Sapphire 800 Users Manual

User Manual of SAPPHIRE 800 Auto-Chemistry Analyzer
800
USERs MANUAL
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Instruction:
Dear user, thanks for purchasing our SAPPHIRE 800 Auto-Chemistry Analyzer.
Please read the user manual carefully in order to operate the instrument correctly. Incorrect operation may
affect the precision and accuracy of the test results, or endanger personal safety.
Please keep the user manual safely for your any time reference.
Note:
Instrument should be operated by medical inspection specialist, physician, nurse or lab assistant who are
specially trained.
Instrument should be controlled by special software. Please install the software that is appointed by our
company. Installation of other software/hardware may interferer normal operation. Dont operate other software
when instrument operating.
Dust may accumulate on the surface of instrument after long time storage. Soft cloth or gauze can be used for
cleaning work, and a little detergent can be used if necessary. Please cut off the power supply before cleaning.
When instrument is not used, make sure shut the lid down.
As to the use and storage method of the sample, reagent, Controls, Calibrator, please refer to the relevant
instructions.
Sample, Controls, Calibrator and waster solution have the potential biochemical infectivity, the detergents are
corrosive that may hurt eyes, skin and mucosa. Operator should refer to the safety regulation for lab operation.
Protective measure should be taken to operator (Such as lab protective clothes and gloves).
Avoid contact with eyes and skin, in case of skin contact, flush the area with water, rinse immediately with
plenty of water and seek medical advice.
Operator should comply with the local regulation when draining and dealing with reagent, waste solution,
waste sample, consumable etc. Please dispose the waste solution and instrument consumable according to the
regulation of medical waste, infective waste and industrial waste.
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Warning:
Instrument should be operated in a good ground condition, and an independent power supply is a must, the
input power should be conformed to instrument requirement.
Dont pull the electrical wire with wet hand, or there is a risk of electrical shock.
Doesnt stamp, twist, drag the wire and cable, or it may cause a fire.
Please dont open the back and side cover board before cutting the general power supply except Audit
Diagnostics special service staff.
If liquid occurs in instrument interior or there is an internal pipeline leakage, please immediately cut off the
general power supply, and contact Audit Diagnostics customer service dept.
Please dont touch sample probe, reagent probe and stirring rod, etc. when instrument operating, dont put
your hand into the opening part, or it may cause body injury or instrument damage.
Cut off the power supply before replace light source lamp. Dont touch the lamp before it is cool to avoid
burning.
Periodic maintenance should be executed strictly according to the user manual. Or it may cause instrument
malfunction, and affect the accuracy and precision of test results.
Make sure that the Auto-Chemistry Analyzer is operated according to the user manual, or the measuring
result is not a reliable one, and the damage on instrument may endanger human safety.
Please dont place combustible material around the instrument.
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Catalogue
Chapter 1 Brief Introduction...............................................................................................................................1
1.1 Summary........................................................................................................................................................1
1.2 Main technical index .....................................................................................................................................1
1.3 Composition of instrument ............................................................................................................................3
1.4 Configuration and function ............................................................................................................................8
1.5 Instrument Symbol ......................................................................................................................................21
Chapter 2 Function and Measuring Principle ...................................................................................................22
2.1 Mechanism movement principle..................................................................................................................22
2.2 Assay mode .................................................................................................................................................25
2.3 Check of measure value ...............................................................................................................................61
2.4 ISE testing principle ....................................................................................................................................66
Chapter 3 Instrument Installation .....................................................................................................................69
3.1 Installation requirement ...............................................................................................................................70
3.2 Open package ..............................................................................................................................................71
3.3 Installation procedure ..................................................................................................................................72
Chapter 4 Accessory Device.............................................................................................................................79
4.1 Sample disk barcode reader .........................................................................................................................79
4.2 Reagent barcode reader ...............................................................................................................................80
4.3 Purified water equipment.............................................................................................................................83
Chapter 5 SAPPHIRE 800 Software Operation ...............................................................................................84
5.1 Software interface instruction ......................................................................................................................84
5.2 Software Operation ......................................................................................................................................88
5.3 Instrument standard specification ................................................................................................................92
Chapter 6 Instrument Operation .......................................................................................................................94
6.1 Overview of operation .................................................................................................................................94
6.2 Detailed operation........................................................................................................................................95
Chapter 7 Calibration Information..................................................................................................................137
7.1 Colorimetric calibration .............................................................................................................................137
7.2 ISE calibration ...........................................................................................................................................143
Chapter 8 Quality Control ..............................................................................................................................145
8.1 QC registration ..........................................................................................................................................145
8.2 QC interval ................................................................................................................................................150
8.3 Monthly quality control .............................................................................................................................153
Chapter 9 System Setup ..................................................................................................................................155
9.1 Chemistry parameter..................................................................................................................................155
9.2 Item combination .......................................................................................................................................163
9.3 Calculated item ..........................................................................................................................................164
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9.4 Cross contamination ..................................................................................................................................166

9.5 Report sheet format ...................................................................................................................................169
9.6 ISE Setup ...................................................................................................................................................173
9.7 Other setup.................................................................................................................................................174
9.8 Manual item setup .....................................................................................................................................175
9.9 Host communication setup ........................................................................................................................176
9.10 Reagent setup...........................................................................................................................................178
Chapter 10 System management ....................................................................................................................179
10.1 User information ......................................................................................................................................179
10.2 Hospital information ................................................................................................................................180
10.3 Other information ....................................................................................................................................182
10.4 Workload statistics ..................................................................................................................................187
10.5 Database maintenance .............................................................................................................................189
10.6 System log ...............................................................................................................................................190
Chapter 11 System Help .................................................................................................................................191
11.1 System help application ...........................................................................................................................191
Chapter 12 System Maintenance ....................................................................................................................192
12.1 System maintenance preparation .............................................................................................................192
12.2 The Application of system maintenance menu ........................................................................................193
12.3 Maintenance and checkup points and parts .............................................................................................203
12.4 Maintenance and check up method..........................................................................................................206
12.5 ISE device maintenance...........................................................................................................................229
Chapter 13 Alarm Data Processing.................................................................................................................236
13.1 Alarm information type ...........................................................................................................................236
13.2 Countermeasure to malfunction do not issue alarm.................................................................................236
13.3 Instrument alarm list ................................................................................................................................238
Chapter 14 Risk Evaluation ............................................................................................................................267
Chapter 15 Instrument Transportation and Storage ........................................................................................273
15.1 Transportation requirement .....................................................................................................................273
15.2 Storage requirement.................................................................................................................................273
15.3 Storage environment ................................................................................................................................273
Addendum A Product Warranty ......................................................................................................................274
Addendum B Product Description ..................................................................................................................275
Statement ...........................................................................................................................................................280
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Chapter 1 Brief Introduction
1.1 Summary
SAPPHIRE 800 Auto-Chemistry Analyzer is an instrument with discrete system, reagent open function,
emergency priority function as well as an external computer. The instrument is composed of humanized software
operation system, intelligent zed optical unit, complicated mechanism system, precision liquid path and accuracy
electrical system. The instrument could automatically realize sampling, reagent injection, anti-interference,
mixture, pre-temperature, reaction measurement, rinse, calculation, display and print function. The substitution
of manual operation for automatic operation could not only enhance the working efficient but also decrease the
test error, thus greatly enhance the accuracy and precision of test results.
SAPPHIRE 800 Auto-Chemistry Analyzer could carry out the immunology check and biochemical analyze of
blood, urine, ascites, cerebrospinal fluid and other body fluid. The instrument could also carry out clinic test,
such as: myocardium enzymogram, blood sugar, blood fat, liver function, renal function, immunoglobulin, etc.
1.2 Main technical index
Instrument structure: Discrete system
Throughput: Constant speed, 400 tests/ hour (800 tests/ hour with ISE)
Simultaneous analysis item No.: At most 88 colorimetric items,
3 ISE items (K, Na, Cl).
Sample volume: 2 to 35l (Stepping 0.1l)
Reagent volume: 20 to 350l (Stepping 1l)
Reaction solution volume: 150450l
Liquid level sensor: Integration of sample probe and reagent probe with touch sensor and sample probe
block test function.
Stirring: Independent stirring after reagent injecting.
Sample disk : 115 samples position (50 routine samples, 34 Calibrators, 20 STAS samples, 8
Controls, 3 Detergents)
Reagent disk: Dual disk
Disk 1: 45 positions for Reagent 1, Reagent 4, diluents and CS anti-bacterial

phosphor-free detergent.
Disk 2: 45 positions for Reagent 2, Reagent 3, CS anti-bacterial phosphor-free

detergent.
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Photometer: Grating spectrophotometry system in a range of 340750nm, wavelength: 340,
380, 405, 450, 480, 505, 546, 570, 600, 660, 700, 750nm
Wave length accuracy: 2nm
Light source: 20W /12V Long life quartz halogen lamp (water cooling)
Measurement range: 0 to 3.3Abs
Reaction disk: 120 pcs of reusable rigid optical plastic reaction cuvette.
Reaction cuvette optical diameter: 6mm
Reaction cuvette rinse: Automatic
Incubation bath temperature: 370.1
Reaction time: 15 minutes at most (optional for 3, 4, 5, 10 and 15 minutes)
Analysis method: Rate assay, end-point assay, 2-point assay.
Calibration method: 1-point linearity, 2-point linearity, multi-point linearity, non-linearity method.
Reagent bottle volume: 20ml, 70ml
Reagent cooling unit: All reagents keep at 5 - 15, semiconductor refrigeration.
Barcode scanning: 3 internal barcode scanner (scan the barcode on the routine sample, and reagent
on the R1, R2 disk)
Reagent volume test : Test and report the reagent remaining volume.
Power supply: ~220/230V 50Hz
Ambient temperature: 1532 Optimum temperature: 18 to 25
Relative humidity: 40% 85%
Appearance dimension: 10607901150mm (lengthwidthheight)
Fixing power: 2000VA
Weight: About 300Kg
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1.3 Composition of instrument
1.3.1 Appearance of instrument

1.3.1.1 Front of instrument
Model symbol Cover Left front door Right front door
Figure 1-1 Front of instrument
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1.3.1.2 Front of opening door
ISE pipetting syringe ISE diluting syringe ISE inner standard solution syringe
CS-Alkaline detergent port Sample syringe R2 syringe R1 syringe
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Figure 1-2 Front of opening door
1.3.1.3 Rear of instrument
Power supply inlet RS-232 interface Cooling fan Diluted waste solution outlet
Purified water inlet Vacuum tank waste solution outlet Concentrated waste outlet
Port of concentrated waste level sensor
Figure 1-3 Rear of instrument

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1.3.1.4 Top of instrument

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Sample pipetting mechanism Cuvette rinsing mechanism Reaction disk
R1 stirring mechanism R1 reagent pipetting mechanism R1 reagent disk
Pilot lamp of sample disk rotation cooling lip of inner track of sample disk Sample disk
R2 reagent pipetting mechanism 11 R2 stirring mechanism 12 R2 reagent disk
Figure 1-4 Top of instrument
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1.3.1.5 Right of instrument
Analytical unit switch (cooling power supply is excluded) Pilot lamp of cooling power supply (green)
General power supply switch (breaker) Pilot lamp of power supply (red)
Figure 1-5 Right of instrument
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1.3.2 System configuration
Figure 1-6 System configuration
1.4 Configuration and function
SAPPHIRE 800 Auto-Chemistry Analyzer is composed by operating system and analytical system. The two
parts is connected by RS-232 serial wire.
1.4.1 Operating system

Operating system is composed of host, 17 inch CRT display monitor, keyboard, mouse and printer.
Host computer: Windows XP system
Special applied software and database.
Computer configuration: Basic frequency2.8GHz.
Hard disk160G Memory1G
With RS-232 serial interface, website interface and USB interface.
CRT display monitor: Display all kinds of form, curve and test data of SAPPHIRE 800 software.
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Keyboard: Operation control and data input.
Mouse: Carry out software operation.
Printer: Print out test data and chart.
1.4.2 Analytical system

Analytical system is composed of sample disk, sample pipetting mechanism, reagent disk, reagent pipetting
mechanism, reaction disk, stirring mechanism, cooling system, rinsing mechanism, optical system etc.
1.4.2.1 Sample disk
! Warning:
z When instrument operating, be sure to close the cooling lid on the inner track of sample disk and screw the
knob.
z The sparkling of LED pilot lamp indicates that sample disk is turning or going to turn, do not change
sample or touch sample disk at this time, or it may cause body injury or instrument damage.
Outer track Middle track Inner track Sample disk inner track pin
Handgrip of sample disk inner track Sample disk guide pin Locking block of inner/outer disk
Handgrip of sample disk outer track Sample barcode reader
Figure 1-7 Sample disk
(1) Composition and function
Sample disk is composed of outer track, middle track, inner track and LED pilot lamp. The inner track has
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cooling function, thus the Controls and Calibrator on inner track of disk can be restored in 515.
Place the containers (standard cup, micro cup, test tube) which contain Calibrator, sample, Controls on the
sample disk, and then the sample disk will send them to the sampling position in the sampling mechanism.
(2) Specifications (Sample No.)
(Outer track): For routine samples (1-50).50cups
(Middle track): For Calibrator (S1-S17)...17cups
For STAT sample (E51-E70)... 20 cups
For detergent (W1-W3)..3 cups
(Inner track): For Calibrator (S18-S34)..17 cups
For Controls (C1-C8)....8 cups
(3) Movement
At Power on: Sample disk turns counterclockwise to move routine sample No.1 to the sampling position.
At analysis: At start of analysis, sample disk makes the same movement as power on. During analysis,
sample disk turns to the direction allowing a quicker access.
At resetting: Make the same movement as at power on.
(4) Mounting / dismounting
When mounting the sample disk, be sure to set the sample disk matching with the guide pin. Set the latch
on the inner track. Also, be sure to secure the cooling unit lid on the inner track, the outer track can be
demounted without removing the inner track.
Note:
When mounting/demounting the routine sample disk (outer track), be sure to hold the hooks with both
hands. In order to change the sample in inner track, be sure that sample probe has stopped sampling or
been under the stand-by status and take out the disk cover first. Before operating, please check the disk
position.
(5) Action check
Single-click maintenance key, select mechanism operation checkup, input the check times,
single-click Execute button. Alarm is issued when abnormality exists.
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1.4.2.2 Sampling mechanism
! Warning
Please dont touch the sampling mechanism when operating, or it may cause body injury or instrument
damage.
Sample probe up and down mechanism Sample probe rotation arm
Sample probe Rinsing bath of sample probe
Figure 1-8 Sampling mechanism

(1) Function
Assimilates a specified amount of sample from sample container and pipets it into reaction cuvette. The
sample probe possesses the liquid level detect function. Alarm is issued when touch occurs in descending
process, and alarm is issued also when sample probe is blocked.
(2) Specification
Sampling mechanism can assimilate 2.0-35.0l sample volume, set in 0.1ul stepping. Sample probe will
assimilate more than specified amount. Minimum sample volume requires more than 100 l.
(3) Movement
At power on: The sample probe comes over above the reaction cup, and then returns above the sample
probe rinse bath.
At analysis: The sample probe circulates up and down motions as the following sequence: Sample
container, reaction cuvette, sample rinsing bath. Automatic sample probe rinsing is carried
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out when sampling finished. At start of analysis, the sample probe makes the same
movement as at power on. In the rinsing bath, the inner and outer walls of the probe are
rinsed. Sample probe block test is carried out simultaneously.
At resetting: Makes the same movement as at power on.
Assimilate sample: sampling is taken when sample probe descent 1.7 mm below liquid level.
(4) Automatic rinsing
Automatic rinsing of probe: After assimilating the sample, the sample probe will return above the rinsing
bath to wash the inner and outer walls of probe. When sampling is finished, the CS-alkaline detergent is
assimilated from the position W1 of the sample disk.
(5) Operation check
Single-click the Maintenance key, select mechanism operation checkup and input the check times.
Click Execute. If abnormality exists, instrument will issue alarm.
1.4.2.3 Reagent disk
! Warning:
Please dont touch the lid of the reagent disk when running or it may cause body injury and instrument
damage.
Reagent disk cover Locking knob of cover Reagent bottle (on the reagent rack)
Track pin of reagent disk Handgrip of reagent disk. Reagent disk guide pin
Reagent disk open detector
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Figure 1-9 Reagent disk

(1) Function
The reagent disk accommodates reagent bottles and carries the specific reagent, diluents and
CS-anti-bacterial phosphor-free detergent to the pipetting position in pipetting mechanism. Cooling
system can keep the reagent disk in a lower temperature to store reagent. There is a barcode reader on the
wall of reagent cooling unit, which can scan the barcode on reagent bottle.
(2) Specification
Reagent disk 1 (R1): R1, R4, diluents and detergent, total 45 bottles. Number 45 position is specially
used for CS-anti-bacterial phosphor-free detergent.
Reagent disk 2 (R2): R2, R3, diluents and detergent, total 45 bottles. Number 45 position is specially
used for CS-anti-bacterial phosphor-free detergent.
Reagent bottle capacity: 70ml, 20ml
Single-reagent usage: Single-reagent can be used as Reagent 1 or Reagent 2 that is putted into both
two reagent disk.
(3) Movement
At power on: Turning clockwise, Position 1 of R1 and R2 disks carry each bottle to the reagent pipetting
position.
At analysis: Initial operation is the same as at power on. Subsequently, the disks rotate in the direction
which allows a quicker access.
At resetting: Make sure same as at power on.
(4) Operation check
(5) Mounting/ Dismounting
Fix the disk with 2 latches at the center of disk. To remove the disk, loose the latches. For mounting, be
sure to set the disk matching with the guide pin and fasten it with the latches. The reagent disk cover
must be attached except for replacement of the disk of reagent. During operation, the reagent probe may
moves, so avoid detaching the reagent disk cover at this time.
Note:
If operator open the disk cover during stand-by or running state, alarm occurs. Reagent horizontal
scanning will be automatically carried out when cover the reagent disk lid at stand-by status.
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1.4.2.4 Reagent pipetting mechanism
! Warning:
Be sure to close the lid of reagent disk when instrument operating, and fasten the knob.
Reagent probe up and down mechanism Rotating arm of reagent probe
Reagent probe Rinsing bath of reagent probe
Figure 1-10 Reagent pipetting mechanism
(1) Function
Assimilate a specified amount of reagent from each reagent bottle and pipets it into a reaction cuvette. The
reagent probe acts as a sensor at the liquid surface level. The remaining amount of reagent in a bottle is
calculated from the descending distance of reagent probe and displayed on the reagent info. menu.
(2) Specification
Reagent volume: 20 to 350ul set in 1 ul stepping.
(3) Movement
At power on: Move toward the reaction cup side once and then returns above the probe rinsing bath.
At analysis: Reagent probe circulates the motion as the following sequence: reagent bottle--reaction
cuvette--reagent probe rinsing bath.
At resetting: Make the same action as at power on.
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Assimilate CS-anti-bacterial phosphor-free detergent from the position 45 on the reagent disk for three
times and infuse it into reaction cuvette for three times and return to the probe rinsing bath to wash inner
and outer walls of the probe.
(5) Movement check
1.4.2.5 Reaction disk
! Warning:
Please dont touch the reaction disks during operating, or it may cause mechanical failure.
Reaction cuvette rinsing mechanism Reaction disk Fixing screw
Fixing knob of reaction disk Guide pin and hole Reaction cup groupware handgrip
Figure 1-11 Reaction disk
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(1) Function
Fasten reaction cuvette by screw, and be sure to keep chemical reaction in constant temperature of 37.
Each reaction cuvette also serves as a cell for absorbance measurement.
(2) Specification
Reaction cuvettes No: 20 cuvettes/set6 sets (120 cuvettes in total)
Optical diameter: 6mm
Material of reaction cuvette: Optical plastic
(3) Operation
Always rotates counterclockwise
At power on: Rotates and stops at the start position. At this time, the first reaction cuvette is located under
the first rinse nozzle.
At analysis: Initially operates the same as at power on, then circulates a cycle of half turn and one pitch
advance (covering 61 reaction cuvettes) followed by temporary stop. Each full turn takes about 18
seconds.
At resetting: Make the same action as at power on.
(4) Rinsing
At position No.45 of both reagent disks, set a bottle containing CS-anti-bacterial phosphor-free detergent
and open its cap. Carry out rinsing reaction cuvette in the maintenance window, all the reaction
cuvettes will be rinsed. It is usually rinsed by CS-alkaline detergent in the front-left of instrument, so daily
maintenance for reaction cuvettes is unnecessary.
(5) Operation check
Single-click the Maintenance key, select mechanism movement checkup, and input the check times.
Click Execute. If abnormal exist, instrument will issue alarm.
(6) Demounting
Reaction disk: Remove the rinse mechanism from above the reaction disk and completely loosen the
fixing knob at the center. The reaction disk can be lifted out. For mounting, align the guide pin of
instrument with the guide hole of the reaction disk and tighten the fixing screw.
Reaction cuvette: Remove the cuvette setscrew and pull up the reaction cuvette block by holding the
handgrip, and the reaction cuvette can be removed from the reaction disk.
Note: Keep reaction cuvette immersed in purified water. Besides, if the instrument will be not used more than
3 days, reaction cuvette should be removed and immersed in purified water.
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1.4.2.6 Incubation bath
! Warning:
Keep the cleanness of purified water in incubation bath, or it may effect the test precision.
When instrument startup or rinsing incubation bath, make sure there is enough CS-anti-bacterial
phosphor-free detergent at No.45 position.
(1) Function
Keep the reaction solution in the reaction cuvette at a constant temperature.
(2) Operation
At power on: Automatic exchanges the constant temperature water once, the CS-anti-bacterial
phosphor-free detergent in position No.45 of both reagent disks is added in incubation bath.
At analysis: Incubation bath water is circulating. Instrument may automatically supply water when water
shortage comes in operation process.
Exchange water: In maintenance window, select rinsing incubation bath, and then the constant
temperature water may exchange, and then add 6ml CS anti-bacterial phosphor-free detergent in incubation
bath water.
Note: After running for 24 hours, instrument may require incubation bath water exchange, please carry out
Rinsing incubation bath.
1.4.2.7 Stirring mechanism
!Warning:
Please dont touch stirring mechanism When operate, or it may cause body injury or instrument damage.
(1) Function
Stirring the reaction solution in each reaction cuvette.
(2) Operation
At power on: Move to the side of reaction cuvette and then stops above the rinsing bath, move to the
side of reaction cuvette again, and then stops above the rinsing bath.
At analysis: The mechanism descends, rotates, rises and stops between two locations: reaction cuvette
and stirring rod rinsing bath.
Stirring is carried out after each addition of reagent 1(R1), reagent 2(R2), reagent3(R3), reagent 4(R4).
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R1 and R4 use Stirring rod mechanism 1. R2 and R3 use Stirring rod mechanism 2.
Automatic rinsing of stirring rod: when stirring rod descends into stirring rod rinsing bath, mechanism
may automatically rotate and washes the stirring rod with purified water.
Sampling finishing: Stirring rod is stirring in reaction cuvette in which detergent is added, thus rinse the
stirring rod.
(4) Operation check
Single-click the maintenance key, select mechanism operation check, and input the check times.
1.4.2.8 Reaction cuvette rinsing mechanism

! Warning:
Please dont touch the rinsing mechanism when operate, or it may cause body injury or instrument
damage.
Avoid directly contact with body, or it may cause infection. Please adopt protective measure. In case of
skin contact, flush the area with water, rinse immediately with plenty of water and seek medical advice.
(1) Function
Eliminates the reaction solution, rinse the reaction cuvette, injects and eliminates purified water which
used for test cell blank.
(2) Composition of rinsing nozzle
B F G F
C D A B A B E
Rotational direction of 4 times cell blank measurement, 1 stop, 3 pass.

Reaction disk
Figure 12 Arrangement of Rinse Nozzles
Above figure shows that seven steps are needed when rinsing reaction cuvette. (Four times cell blank test is
added), therefore, to finish rinsing one reaction cuvette, 11 steps are needed.
Step 1: Nozzle 1D assimilates reaction solution, then 1C discharges detergent to reaction cuvette.
Step 2: Nozzle 2B assimilate detergent from reaction cuvette, then 2A discharges purified water to reaction
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cuvette.
Step 3: Nozzle 3B assimilates the purified water from reaction cuvette, then 3A discharges the purified
water to reaction cuvette.
Step 4: Nozzle 4B assimilates the purified water from reaction cuvette, and wipes the reaction cuvette at
the same time.
Step 5: Nozzle 5E discharges the purified water to reaction cuvette.
Step 6, 7, 8, and 9: Carry out the cell blank check measurement at the fifth nozzle. The reaction cuvette
with full purified water allows 4 times cell blank measurement. (1 time static measurement, 3
times dynamic measurement when reaction cuvette passed by during reaction disk turning)
Step 10: Nozzle 6F assimilates the purified water, which has carried out the cell blank absorbency check.
Step 11: Nozzle 7F assimilates the remaining water in reaction cuvette, and wipes the reaction cuvette at
the same time. Nozzle 7G only discharges the purified water in rinsing process before sampling,
rinse the nozzle tip.
Distribution of 11 rinsing nozzles:
A. For discharging purified water .2 nozzles
B. For assimilating rinse water.3 nozzles
C. For discharging detergent..1 nozzle
D. For assimilating reaction solution ... 1 nozzle
E. For discharging purified water for cup blank1 nozzle
F. For aspirating purified water for cup blank.2 nozzles
G. For discharging purified water ..1 nozzle
(3) Operation
At power on: Rises when already down
At analysis: Rinse the reaction cuvette and carry out the water blank test in the rotational direction of
arrangement of rinse nozzle in Figure.1-13.
(4) Operation check
Single-click the maintenance key, select mechanism operation check, and input the check times.
Click Execute. If abnormality exist, instrument will issue alarm.
(5) Dismounting
The rinse mechanism can be shifted from the reaction disk by loosening the fixing screw at the head.
1.4.2.9 Reagent cooling system

(1) Composition and function:
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Cooling system is composed of reagent cooling system and sample cooling system, which could cool the
reagent, controls and Calibrator respectively.
2Specifications
Temperature: 5 -- 15
Warning:
Even the analyzing system is power off, cooling system is still at working status. The cooling system
only stop working when main power supply is cut off.
The usage and storage of Reagent should be performed strictly according to user manual.
1.4.2.10 Optical system
Concave
Detector (340-750nm) diffraction
12 fixed wavelength grating
Light source
Reaction
lamp
cuvette
Figure 1-13 Photometer

(1) Function
When the reaction disk rotates, the absorbance of purified water or reaction solution is measured in each
reaction cuvette. As above figure shows.
(2) Specification:
Carry out photometry with dual-wavelength or single-wavelength at wavelengths: 340nm, 380nm, 405nm,
450nm, 480nm, 505nm, 546nm, 570nm, 600nm, 660nm, 700nm, 750nm.
Wavelength accuracy: 2nm
Measuring range: 0-3.3 Abs
Spectral bandwidth: FHW 8 to 10nm
Detector: Silicon photodiode
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Light source: 12V, 20W halogen lamp
1.5 Instrument Symbol
Symbol Meaning
To perform as the instruction under the symbol,

emphasize the important information and special contents.
To perform as the instruction under the mark,

or it may cause biological infection
AC symbol
Only diagnostic use
Storage at
Batch code
Use by
Serial number
Measurement Control
Date of Manufacture
Grounding terminal
Table 1-2 Instrument symbol

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Chapter 2 Function and Measuring Principle

The function and measuring principle is composed of mechanism movement principle and analyzing assay.
2.1 Mechanism movement principle
SAPPHIRE 800 Auto-Chemistry Analyzer consists primarily of the sample disk, sampling mechanism, reagent
disk, reagent pipeting mechanism, reaction disk, reaction bath, rinsing mechanism and photometer.
Operation of each mechanism is explained according to figure 2-1:
After starting, instrument carries out resetting first, rotates the R1 reagent disk and R2 reagent disk to Position
1, then rotate them for 360 degrees, the R1 reagent probe, R2 reagent probe, sample probe, R1 stirring rod,
R2 stirring rod are all stopped at the upper side of their rinsing bathes respectively.
Upon pressing the start key, the rinse mechanism starts rinsing from reaction cuvette No1. The reaction disk
rotates by 22 patches and stops temporarily, and then rotates by 37 patches and stops, sequently, 2 more
patches and then stops. This sequence is carried out again to cover one full turn plus 2 patches (18 seconds).
Cell blank is measured when the reaction cuvette passes through the photometric unit during rotation of the
reaction disk. The measured value of cell blank becomes the reference value for the subsequent absorbance
measurement. The liquid in the reaction cuvette is assimilated through the nozzle of rinse mechanism.
After rinsing the reaction cuvette for 3 minutes (the reaction disk rotates 10 circles), the sampling mechanism
begins to work when reaction disk rotates the 11th turns, and the sample probe moves above of the sample cup
and decends into the cup. Since the sample probe comprises a liquid level sensor, the probe stops descending
when its tip enters the sample. A set volume of sample is assimilated with the sample pipettor. Next, the
sample probe moves to the top of No.1 reaction cup and descends until its tip reaches the bottom of the cuvette,
where the sample is discharged. The sample probe further moves to the inside of probe rinsing bath, where its
inner and outer walls are washed with purified water.
On the other hand, the reagent pipetting mechanism assimilates reagent 1 (with R1 probe), while the reaction
disk rotates by 22 patches, stops temporarily and the rotates by 37 patches after the fore mentioned sampling
mechanism has discharged the sample into the reaction cuvette. When the reaction disk stops temporarily after
the above rotation, reagent 1 is discharged into the reaction cuvette. And when the reaction disk stops
temporarily after rotating by 2 patches, the R1 stirring mechanism mixes the sample and reagent. The reagent
pipetting mechanism rotates to the top of reagent bottle in the specified channel and descends while assimilates
and discharges reagent. A set volume of reagent is assimilated, then the reagent probe moves to the top of
reaction cuvette and discharges the reagent, followed by returning to the rinsing bath and washing of its inner
and outer walls. Add reagent R1 and start photometry. Measurement is made when each reaction cuvette
passes through the optical path during rotation of the reaction disk. The reaction disk rotates15 turns plus 22
patches to the reagent 2 pipetting position, where reagent 2 is added with R2 probe. Reagent 2 is stirred with
the R2 stirring mechanism after the reaction disk rotates by 16 turn plus 2 patches and stops temporarily, and
then rotates 22 patches and stops temporarily.
After 26 turns plus 37 patches , reaction disk comes to the reagent 3 sampling position, and reagent probe 2
assimilates reagent 3. R2 stirring rod begins to work after 2 more patches of reaction cuvette.
After 41 turns plus 37 patches , reaction disk comes to the reagent 4 sampling position, and reagent probe 1
22
assimilates reagent 4. R1 stirring rod begins to work after 2 more patches of reaction cuvette
After the lapse of about 15 minutes (60 circles), the first cup measurement is over, and the reaction solution in
No. 1 reaction cup is assimilated with the nozzle of cuvette rinsing mechanism, which will discharge cleaning
liquid and water into the reaction cup to rinse the cup. The instrument stops and goes to standby status when
the last reaction cuvette has been washed, and goes to the the cell blank status. The reagent probe and sample
probe will be rinsed respectively by their own detergents added by themselves after every test.
Reagent combination (R1, R2, R3, R4) of each item and reaction time (3~15 mins) is set in the Analytical
parameter form in System setup.
2.1.1 Operating Position

Operating principle of 120 reaction cuvette is showed as below:
Reset point
Rinsing mechanism Position No. of reaction cuvette
Photoelectric
detection
Sop and wipe

62,R1 stirring
position
63,R4 stirring
Sample probe
position
60 R1 Pipetting
61 R4 Pipetting
Reference position
number
Reagent probe 2,3 Stirring probe
Figure 2-1 Each mechanism operation position
23
2.1.2 Analytical flow

The analytical flow of SAPPHIRE 800 Auto-Chemistry Analyzer is show in figure 2-2:
Table 2-1 Analytical flow
2.1.3 Photometric Features

This instrument adopts the whole reaction monitoring system, which intermittently measures the absorbance of
reaction solution for a reaction time of 15 minutes.
The reaction disk rotates 1 turn plus 2 pitches in about 18 seconds and during this time the absorbance is
measured for all of 120 reaction cuvettes which go across the optical axis of the photometer. For each reaction
cuvette, measurement is made10 times in a reaction time of about 3 minutes. 13 times measurement is made
during 4 minutes (13 photo metric point.). 16 times measurement is made during 5 minutes (16 photo metric
point33 times measurement is made during 10 minutes (33 photo metric point.) .49 times measurement is
made during 15 minutes (49 photo metric point.).
SAPPHIRE 800 multi-wavelength photometer condenses the white light emitted from the light source lamp
through the lens, passes the condensed light through the reaction cuvette and separates the light with the
concave diffraction grating. The separated respective wavelength components are simultaneously received on
the 12 fixed detectors and amplified by 12 amplifiers, then logarithmically converted to obtain the absorbance
or difference in absorbance. In 2 wavelengths photometry, concentration is measured by the value of the
difference of dominant wavelength and complementary wavelength. This means that the photometer features a
24
correcting effect for lipemia, hemolysis and icterus of sample and has a compensating effect for fluctuation in
source voltage, thus realizing stable measurement.
2.2 Assay mode
The assay mode of Auto-Chemistry Analyzer is based on the Beer-Lambert law that the material selective
absorption light.
The main principle is: When monochromatic light with specific wavelength passes through the cuvette with
sample, the monochromatic light absorbency and sample liquid concentration are varies directly as the
distance which is passed through sample liquid by light:
I
A = lg1/T= lg 0 = b c
It
A Absorbency of the light when passing through liquid
T Transmitted intensity and incident intensity ratio: transmittance It/I0
I0 Incident intensity
It Transmitted intensity
Molar absorption coefficient of solutionmlmmol1cm1
c Mol concentration of the solutionmmol/ml
b Solution layer thicknesscm
Solution layer thickness (b): Optical path, which is fixed by instrument. Molar absorption coefficient () is the
correlation coefficient of the wavelength, solution and solution temperature. Linear relationship is displayed
between solution thickness and absorbency when in stable temperature and single wavelength ( value is given
on the reagent bottle by factory).
If the sample liquid adequate distribution, interaction between liquid and incidence monochromatic light only
happens during absorbing process. No fluorescence, disperse and photochemical appear. No interaction
between substances in the solution while absorbing process. The absorbency possess conducts nature, and this
condition conforms to the Beer-Lambert law
25
2.2.1 Assay mode variety

As to how to set the assay parameter and standard liquid parameter, please refer to user manual. Assay mode is
showed as table 2-2:
Method Item Photometry point Cell blank Formula Note
L 0 0 0
1-point B1 + B 2 + B 3 AL + AL 1
Assay 1L49 3 2
t : time
L M 0- 0 (minute)
2-point B1 + B 2 + B 3 ( AM + AM 1 ) k ( AL + AL 1 )
between
Rate Assay 1LM49 3 2 photometry
point L,m
L M 0 0 AM + AM 1 AL + AL 1
2-point B1 + B 2 + B 3
assay 2 2
1LM49 3
t
L M 0 - 0
1LM49 B1 + B 2 + B 3
First half A( M L )
3
1-point &
L +2M
Rate Assay
L 0 0 0
Second B1 + B 2 + B 3 AL + AL 1
half 1MNLPQ49 3 2
MNPQ
Rate A 1MNLPQ49 B1 + B 2 + B 3
Assay AQ- P-kAN -M
3
M+2N, P+2Q
Rate A
Assay with L 0 0 0
Serum B1 + B 2 + B 3 AL + AL 1
Index
Measurem
1LMN49 3 2
ent.
MN00
Rate B B1 + B 2 + B 3 ( AN + AN 1 ) k ( AM + AM 1 )
Assay First half
(mode 1 ) 1LMN49 3 2
26
P-Ndifferent wavelength from

L M 0 0
Second 3LMNP49 B1 + B 2 + B 3 the first Half Two

half 3 conditions
L +2M A(P-N)k A(M-L) (same
wavelength as the second half)

NP00
3LMNP49 B1 + B 2 + B 3
First half A( M L )
3
N+2P
Rate B
Assay L M 0 0
(mode 2 )
3L M N P Q
Second B1 + B 2 + B 3
A(R-Q) kA(P-N)
half R49 3
L +2M
Table 2-2 Assay mode table
Explanation of symbols:
L, m, n, p, q, r : Photometric points
Rn : Volume of nth reagent ,n=1 to 4
SB : Stopped cell blank
B1, B2, B3 : Passed cell blanks
Ax : Absorbance at photometric point x
A(m-L) : Change in absorbance per minute between photometric points L and M
k : Liquid volume correction factor
a
S + Rj
j =1
k= b
S + Ri
i =1
S : Sample volume
Rj ,Ri : No. of reagents with correction (at Al measurement)
B : No. of reagents without correction (at Am measurement)
Note 1: The 5 th Photometric point wont be Stirred after adding reagent 2. Stirring when the reaction disk
pauses after rotates one circle plus 2 pitches.
27
Note 2: liquid in the reaction cuvette should be more than or equal to 150 ul, less than or equal to 450ul.
Note 3: Do input 0 if the photometric point is not used.
(1) 1-point Assay

Endpoint assay in which absorbance is measured at a designated photometric point (specific time point when
reaction reach balance) after addition of reagents. Figure 2-2 explains the 1-point assay.
Absorbance
Cell blanks
/ R2 R4
R1
A L + A L 1
S 2
SB B1 B2 B3
Time
Figure 2-2 1-point Assay
(a) Photometric point : L-0-0-0 1< L 49
(b) Calculation of absorbance
The average of absorbance at measurement points Land L-1 is used.
AL + AL 1
AX =
2
(c) Calculation of concentration
C X = {K ( AX B ) + C1 } IFA + IFB
SB: Stopped cup blank
R1~R3: Passed cup blank
R1~R4: Reagent adding position
Cx: Concentration of standby sample
C1: Concentration of standard 1 solution(reagent blank)
K: Factor
28
B: Absorbance of blank
IFA and IFB: Instrument constants, representing slope and intercept
(d) Analytical items
TP, ALB, etc.
(2) 2-point Assay

Endpoint assay in which measurement is made twice at different points to obtain the difference in absorbance.
One point is measured as the action initial, the other point is measured when the action reach endpoint or
balance. The difference between the absorbance of two photometric points is used for calculation sample
concentration. Figure 2-3 explains the 2-point assay:
Absorbance
Cell blanks
/ R2 R4
A m + A m 1
R1
2
S A L + A L 1
2
SB B1 B2 B3
Time
Figure 2-3 2-point Assay
(a) Photometric point : L-M-0-0 1 L 49
The difference between the average of absorbance at measurement point m and m-1 and that at
measurement point l and l-1 is used.
AX=
( Am + Am 1) k ( AL + AL 1)
2
a
S + Rj
j 1
k= b
S + Ri
i 1
a: No. of reagents at Al measurement
b: No. of reagents at Am measurement
29
C X = {K ( AX B ) + C1 } IFA + IFB
R1~R3: Passed cup blank
Ax: the deference between the photometric point M and L
Cx concentration of standby sample
C1: Concentration of standard 1 solution(reagent blank)
K: Factor
IFA and IFB: Instrument constants, representing slope and intercept
CRE, etc.
(3) 2-point Rate Assay

Measurement is made twice at different measurement points (The two point are neither measured initial nor
endpoint) to determine the change in absorbance per minute in order to calculate sample concentration. For
check of reaction limit level, refer to Figure 2-4:
Absorbance
Reaction limit level

Am-1 Am
Cell blanks R2 R4
/ AL
AL-1 A m + A m 1
R1
A L + A L 1 2
S
2
t
SB B1 B2 B3
Time
Figure 2-4 2-point Rate Assay
30
(a) Photometric point : L-M-0-0 1< L <M 49
The difference between the average of absorbance at measurement points M and M-1 and that at
measurement points L and L-1, then divide the result by time.
( Am + Am 1) ( AL + AL 1)

AX= 2 2
t
t: Time (minute) between measurement points L and M
C X = {K ( AX B ) + C1 } IFA + IFB
B1~B3: Passed cup blank
Ax: Average change in absorbance per minute between measurement points L and M
C1: Concentration of standard solution 1(reagent blank)
K: Factor
IFA and IFB: Instrument constants, representing slope and intercept.
BUN, CRE etc.
31
(4) Rate A Assay

Ordinary Rate Assay. The concentration or activity level is obtained from the change in absorbance between
the specified measurement points. Figure 2-5 explains the Rate A Assay.
S
Absorbance
R1
R2 R4
Cell blanks
AL Am
S B1 B2 B3
Time
Figure 2-5 Rate A Assay
(a) Photometric point : L-M-0-0 1<L <M 49 L+2<m)
The change in absorbance per minute between measurement point L and M is obtained by the least
squares method
AX=A(L-m)
C X = {K ( AX B ) + C1 } IFA + IFB
A(L-m): Change in absorbance per minute between measurement point L and M
32
K: Factor
AST, ALT, etc.
(5) 1-point & Rate Assay

Two tests are analyzed by the endpoint assay and rate assay in a single channel. Test A is analyzed by the
endpoint assay in the first half of the specified reaction time and test B is analyzed by the rate assay in the
second half. Figure 2-6 explains the 1-point & rate assay.
Figure 2-6 1-point& Rate Assay
(a)Input of analytical parameter
Correct input of test A and test B is required respectively
(Text A): Photometric point : L-0-0-0
Dual tests assay: designate B
Text B :Photometric point: M-N-P-Q
1<mnLPQ49
M+2N, P+2Q
For test A, the average of absorbance at measurement points L and L-1 is used, and used for the test B is
33
the difference obtained by subtracting the change in absorbance per minute between measurement
points L and M from that between measurement points N and P
AL + AL 1
AA=
2
AB=Apq-kAmn
a
S + Rj
j 1
K= b
S + Ri
i 1
a: A(N-M): No. of reagents.
b: A(Q-P) : No. of reagents.
(c) Calculation of concentration.
For each of tests A and B, calculation is made according to the following formula.
C X = {K ( AX B ) + C1 } IFA + IFB
Rn: Reagent adding position
AA and AB : Each calculated absorbance of tests A and B
k: Liquid volume correction factor
S: Sample volume
Rj,Ri: Volume of each reagent
Cx: concentration of standby sample
K: Factor
AX: Calculated absorbance
B: absorbance of standard solution 1(reagent blank)
In the rate assay, the change in absorbance per minute is obtained by the least squares method
34
(6) 3-point dual assay

Endpoint assay and endpoint assay without sample blank are carried out simultaneously in the same cup. The
first half reaction time is used for test A, and the left half is used for test B. Figure 2-7 explains the rate A assay
with serum index measurement.
Absorbance
Cell blank
Time
Figure 2-7 3-point dual assay
(a)Input of analytical Parameters
Correct input of test A and test B is required respectively
(Test A)Photometric point : L-0-0-0
(Test B) Photometric point: M-N-0-0
1< LM<N49
The average value of absorbance at photometric points L and L-1 is for test A, and test B, the difference
between the average absorbance at photometric points N and N-1 and that of photometric points Mind
M-1.
AL + AL 1
AA =
2
( AN + AN 1 ) k ( AM + AM 1 )
AB =
2
35
a
S + Rj
j =1
k= b
S + Ri
i =1
a: AM : No. of reagent when tested
b: AN : No. of reagent when tested
C X = {K ( AX B ) + C1 } IFA + IFB
Rn: Reagent adding position
S: Sample volume
K: Factor
(7) Rate B Assay (mode 1)

Two tests are analyzed by the rate assay in a single channel. In the first half of reaction time, test A is measured,
and test B is measured in the second half. In the rate B assay, correction is possible with sample blank and for
an endogenous reaction. However, the method of correction of such reaction varies with measuring wavelength.
So this assay is categorized into modes 1 and 2 for easier explanation. Mode 1 is subdivided depending on
whether or not measuring wavelength is the same between test A and B. Figure 2-8 explains the rate B assay
(mode 1).
36
Figure 2-8 Rate B Assay (mode 1)
When wavelength differs between tests A and B
(a) Input of analytical parameters
Respective entry is required for each of tests A and B.
(Test A) photometric point: L-M-0-0
(Test B ) photometric point: N-P-0-0
3Lmnp49 L+2m,n+2p
Used for test A is the change in absorbance per minute between measurement point l and m, which is
obtained by least squares method. Used for test B is the change in absorbance per minute between
measurement points n and p, which is obtained by the same method, but do not carry out blank
correction.
AA=A(M-L)
AB=A(P-N)
C X = {K ( AX B ) + C1 } IFA + IFB
37
S: Sample volume
K: Factor
When wavelength is the same between tests A and B
(Test B ) photometric point: N-P-0-0
3Lmnp49 L+2m,n+2p
Used for test A is the change in absorbance per minute between measurement points l and m, which is
obtained by least squares method. Used for test B is the difference obtained by subtracting the above
change for test A from the change in absorbance per minute between measurement points n and p, which
is obtained by the same method
AA =AL- M
AB =AP- N-kAL- M
38
a
S + Rj
j =1
k= b
S + Ri
i =1
a: AM - LNo. of reagents with correction
b: AP- QNo. of reagents without correction
C X = {K ( AX B ) + C1 } IFA + IFB
S: Sample volume
K: Factor
39
(8) Rate B Assay (mode 2)

Two tests are analyzed by the rate assay in a single channel. In the first half of reaction time, test A is measured,
and test B is measured in the second half. Correction of endogenous reaction is carried out by using the ratio of
change in absorbance within a time period after measurement of the first test in the first half of reaction time.
Figure 2-9 explains the rate B assay (mode 2).
Figure 2-9 Rate B Assay (mode 2)
(Test B ) photometric point: N-P-Q-R
3Lmnp49 L+2m,n+2R
Used for test A is the change in absorbance per minute between measurement points l and m, which is
obtained by the least squares method. Used for test B is the difference obtained by subtracting the
change in absorbance per minute between measurement points n and p from that between measurement
points q and r, which is obtained by the same method
AA =AL- M
AB =AP- Q-kAP- N
40
a
S + Rj
j =1
k= b
S + Ri
i =1
a: AP- NNo. of reagents
b: AR- QNo. of reagents
C X = {K ( AX B ) + C1 } IFA + IFB
S: Sample volume
K: Factor
2.2.2 Calibration Method

(1) Linearity Method (1-point linearity)
The absorbance and input K value of blank (or standard 1) is measured to prepare a working curve. Figure
2-10 explains the linear method.
41
Absorbance
Concentration
Figure 2-10 1-point linearity
(a) Calibration Parameter input
Calibration type: 1-point linear
Calibration point: 1 (number of standard sample )
Span point: 0
(b) Input K factor in calibration result menu
Input K factor in the calibration result
(c) Calculation of parameters for working curve
S1ABS (B): Change in absorbance per minute of blank (standard 1)
K: Input value.
C1: Concentration of standard 1reagent blank ), input value.
(d) Calculation of concentration
C X = {K ( AX B ) + C1 } IFA + IFB
AX: Calculated absorbance or change of absorbance per minute.
(e) Applicable assay
1-point assay, 2-point rate assay, 2-point assay, 3-point assay, 1-point&rate assay, rate A assay and rate B
assay
42
(2) Linearity Method ( 2-point linearity )

Blank (or standard 1) and standard sample (standard 2) are measured to prepare a linear working curve Figure
2-11 explains the linear method.
Absorbance
Concentration
Figure 2-11 2-point linearity
Calibration type: 2-point linearity
Calibration point: 2 (number of standard sample )
Span point: 2~6
(b) Calculation of parameters for working curve
S1ABS (B): Absorbance or change in absorbance per minute of blank (standard 1)
K: Calculated from measured values and input values of blank (standard 1) and standard sample
(standard 2).
C1: Concentration of standard 1reagent blank)
C2: Concentration of standard 2
A2: Absorbance or change in absorbance per minute of standard 2.
C 2 C1
K=
A2 B
C X = {K ( AX B ) + C1 } IFA + IFB
43
AX: Absorbance or change in absorbance per minute
(d) Applicable assay
assay
(3) Linearity Method (Multi-point linearity)

Blank (or standard 1) and standard samples (standard 2 and standards 6) are measured and linear working
curve. Figure 2-12 explains the linear method.
Absorbance
Concentration
Figure 2-12 Multi-point linearity
Calibration type: multi-point linearity
Calibration point: 3-6 (number of standard sample)
Span point: 3-6
S1ABS (B):Linear primary regression intercept for absorbance or change in absorbance per minute of
blank (standard)
K: Inverse number of working curve slope in the result of linear primary regression.
S1ABS and K values can be calculated by the formulas below:
44
X Cr
S1ABS ( B) = A
Y
Y
K = 10 4 10 a
X
(Cri )( )
n
X: Cr Ai A
i =1
(Cri Cr )
n
2
Y:
i =1
n
A : Ai / n
i =1
n
Cr : Cri / n
i =1
A1, A2: Each measured absorbance in duplicate measurement of standard (1)
n: No. of standards (N) 2
Cri: Concentration of standard (i)
C X = {K ( AX B ) + C1 } IFA + IFB
AX: Absorbance of sample or its change per minute.
(d) Applicable assay
assay
45
(4) Logit-log 3P (Non-linearity Method)

This is applied to a working curve in which the absorbance converges as the concentration increase. Figure
2-13 explains the non-linearity method.
Figure 2-13 Logit-log3P
Calibration type: Logit-log3P
Calibration point: 3-6(number of standard sample)
Span point: 0span calibration invalid
B: the absorbance or approximate value measure of the absorbance change per minute when CX
approaches .
K: blank (standard 1) absorbance or value calculate by the approximation formula of the absorbance
change per minute subtraction B.
a: Constants in approximation formula. Automatically calculated.
B, K, a are displayed on the Calibration List screen.
C X = (C + C1 ) IFA + IFB
K
AX = B +
1 + aC )
46
1 K ( AX B )
C=
a AX B
Cx: Concentration of standby sample.
C1: Blank concentration.
K: Constants in approximation formula. The more Cx approaches , AX approaches B.
When K0, AXB+K or K0, When AXB+K, C=C1
IFA, IFB Instrument constants, representing slope and intercept.
(d) Calculation of SD value
(A )
N 2
, 2
IJ A1
i =1 j =1
SD =
2N 3
N=3~6, j=1or 2
(Aij-Ai): Difference between approximate absorbance Ai and measured value Aij or A12. Each standard
sample is measured in duplicate so the number as measurement points Aij is 12 at maximum.
1-point assay, 2-point rate assay, 2-point assay, Rate A assay.
(5) Logit-log4P (Non-linearity method 2)

It is applied to a working curve in which the absorbance converges as the concentration increases. Figure 2-14
explains the non-linearity method.
Absorbance
Concentration

47
Calibration type: Logit-log4P
Calibration point: 4-6 (number of standard sample)
Span point: 0
B: approximation for the absorbance or its change per minute when CX approaches .
K: Blank (standard 1) absorbance or value calculate by the approximation of the absorbance change per
minute subtraction B.
a ,b : Constants in approximation formula. Automatically calculated.
B,K,a are displayed on the Calibration List screen.
K
AX = B +
1 + aC b
1 K ( AX B )
C = b
a AX B
K: Constants in approximation formula. The more Cx approaches , AX approaches B
When K0, AXB+K or when K0, AXB+K C1=0
IFA,IFB Instrument constants, representing slope and intercept.
(A )
N 2
, 2
IJ A1
i =1 j =1
SD =
2N 4
48
N=4~6,j=1or 2
Aij-Ai: Difference between approximate absorbance Ai and measured value Aij or A12. Each
standard sample is measured in duplicate so the number as measurement points Aij is 12 at maximum
(6) Logit-log5P (Non-linear method 3)

There is no distinct difference between the working curves prepared by the non-linear method 2 and 3.
However, in some cases, the non-linear method 3 allows more accurate approximation because this method has
one more calculation because this method has one more calculation parameter than the non-linear method 2.
Figure 2-15 explain the non-linear method 3.
Absorbance
Concentration
Calibration type : Logit-log5P
Calibration point: 5-6( number of standard sample )
Span point: 0Span point calibration invalid.
B: approximation for the absorbance or its change per minute when CX approaches .
K,a,b,c: Constants in approximation formula. Automatically calculated.
B,K,a ,b,c :are displayed as S1ABS,K,A,B,C on the Calibration List screen.
49
AX B
a+blnC+cC-ln{ }=0
K (A BX )
Calculate C according to the Newton approximation formula.
K
1 + exp ( a b ln C c C )
AX=B+
K: Constants in approximation formula. The more Cx approaches , AX approaches B
When K0, AXB or when K0, AXB, C=0
(A )
N 2
, 2
IJ A1
i =1 j =1
SD =
2N 4
N=5~6,j=1 or 2
(7) Exponential function method (Non-linear method)

Unlike non-linear methods 1, 2 and 3.Exponetial function method prepares a working curve in which the
absorbance disperses as the concentration increases. Figure 2-16 explains the exponential function method.
50
Absorbance
Concentration
Figure 2-16 Exponential function method
Calibration type: exponential function
B: approximation formula for the absorbance or its change per minute of blank (standard 1)
K,a,b,c: Constants in approximation formula. Automatically calculated.
B,K,a ,b,c :are displayed as S1ABS,K,A,B,C on the Calibration List screen.
AX=B+K exp{a (ln C ) + b (ln C ) + c (ln C )

2 3
}
A B
a (ln C ) + b (ln C ) + c (ln C ) -ln X =0
2 3
C1, C2~CN: Blank and standard concentration.
51
When K>0, AXB or when K<0, AXB, C=0
(A )
N 2
, 2
IJ A1
i =1 j =1
SD =
2N 5
N=5~6,j=1 or 2
1-point Assay, 2-point Rate assay, 2-point Assay, Rate A assay.
(8) Spline function method (Non-linear method)

In this method, line is connected in each section so as to form a curve as a whole. Since each section is
smoothed including the error in measured value, more accurate approximation is possible than the polygonal
line approximation. Figure 2-17 explains this method.
Figure 2-17 Spline function method
Calibration type: Spline function
52
A(1),b(1),c(1),d(1): Constants in approximation formula, l=1~N
In the calibration menu, S1ABS show as a (1) (intercept of absorbance axis ).
(
AX=a(I)+b(I) (C X C (1) + c(I)) C X C (1) ) + d (I) (C - C(1) )
3
2
X
f (C X C ( I )) = a ( I ) + b ( I ) (C X C ( I )) + d ( I ) (C X C ( I )) 2 + d ( I ) (C X C ( I )) 3 AX
C1~CN: Blank and standard concentration.
AX, A2~AN: Absorbance of sample and standard or its change per minute.
IFA, IFB Instrument constants, representing slope and intercept.
(A )
N 2
, 2
IJ A1
i =1 j =1
SD =
2N 4
N=5~6,j=1 or 2
1-Point Assay, 2-Point Rate Assay, 2-Point Assay, Rate A Assay.
(9) Polygon method (Non-linear method)

The range between standard samples 1 to 6 is subject to approximation in consideration of measured values
across them and line is connected in each section so as to form a curve as a whole. Since each section is
smoothed including the error in measured value, more accurate approximation is possible than the polygonal
line approximation. Figure 2-18 explains the polygonal line method
53
Absorbance
Concentration
Figure 2-18 Polygon method
Calibration type: polygon
S1ABS is the two measure value (absorbance or its change) of STD (1)
C 2 C1
K=
A2 B
B: Absorbance or its change of standard (1)
A2: Absorbance or its change of standard (2)
C1: standard (1) concentration (input value)
C2: standard (2) concentration (input value)
C X = {K N ( AX AN ) + C N } IFA + IFB
1-Point Assay, 2-Point Rate Assay, 2-Point Assay, Rate A assay.
(10) Isozyme Method

In a sample in which 2 different isozymes coexist, a reagent containing inhibitor may fail to completely
54
suppress the activity of either isozyme alone. In this case, isozyme activity is determined from total activity
and activity residual rate. Each working curve for total activity and isozyme activity are prepared by using 2
channels. If the activity of a specific isozyme of the coexistent two can be suppressed completely by using
monoclonal antibody, etc. this calibration method is unnecessary. As figure 2-19, 2-20 shows:
Absorbance
Absorbance
A2 STD(2)
A3 A3
STD(3)
STD(3)
AF AM Sample
Sample
A4 A4
STD(4) STD(4)
B STD(1) B STD(1)
C1 CF C2 concentration C1 CM concentration
Figure 2-19 Isozyme Method Figure2-20 Isozyme Method
(a) calibration principle
Isozymes method uses 2 reagent position. The total activity Cf is supposed to be calculated first with a
certain reagent in the isozyme P position. Calculate the activity Cm or Cn of isozymes M or N with a
reagent which can suppress N or M substance.
The isozymes M inhibitor testing isozymes M.
Generally speaking isozymes N inhibitor cannot suppress the activity of isozymes N completely, and the
activity of isozymes M is suppressed in a degree at the meantime.
The isozymes Method uses 2 channels to test the total activity and standard cost of isozymes M,N, K
value is tested by total activity channel, both two channels are used.
M and N activity residual rate of M and N is calculated by inhibitor (ratio between absorbance of
standard 3 and standard 4 in two channel.).Calculate the total activity and isozymes M activity upon
above method. The activity of isozymes N is observed by calculation.
(b) Input of parameters:
Reagent and standard samples.
Reagent: Reagent for measurement of total activity, reagent for measurement of isozyme activity.
Standard sample: Standard sample F (containing both isozymes M and N), standard sample M
(containing isozyme M), standard sample N (containing isozyme N)
Reagent position: isozymes M and N are placed in different positions
(d) Entry on Chemistry parameters screen.
Make entry for each of the isozyme P and Q channels as shown in below Table:
55
Con. and Pos.of F Activity Con.and Pos. of M isozyme

Calibrator
(Isozyme P) (Isozyme Q) (Isozyme Q)
(concentration) (position) (concentration) (position)
Blank concentration .. [S1] Blank concentration..[S1]
Calibrator1
Concentration value of calibrator F[S2] 0.0
0 [S3] (Isozyme M Calibrator) 0..[S3](Isozyme M Calibrator)
Calibrator2
0.[S4] (Isozyme N Calibrator) 0. [S4](Isozyme N Calibrator)
Calibrator3
Calibrator4
Table 2-3
S1 to S4 are calibrator code numbers of calibrator 1 to calibrator 4 respectively. Enter the same
calibrator code number in both channels for each of calibrator 1,3,4. Set standard sample of isozyme M
at position Calibrator 3 and that of isozyme N at position Calibrator (4). It is unnecessary to enter the
concentrations of calibrator 3,4,2 for the isozyme Q channel. The channel number M of isozyme M is
specified in the isozyme P channel. But it need not be specified on the isozyme Q side. Unless M is
entered, Isozyme parameter error alarm occurs to disable analysis
(c) Working curve for total activity measurement channel (isozyme P) K factor is calculated by the
following formula:
C 2 C1
K=
A2 B
B: Absorbance of blank (standard 1) or its change per minute
A2: Absorbance of standard sample F (standard 2) or its change per minute
C1: Activity of blank (standard 1 )
C2:Activity of standard sample F(standard 2 )
(d) Calculation of activity for total activity measurement channel (isozyme P)
CF={KAF-B-C1}IFA-IFB
C3={KA3-B-C1}IFA-IFB
C4={KA4-B-C1}IFA-IFB
CF, C3, C4: is sample, activity of standard 3, standard4. Ap, A3, A4: is absorbance or change of the
absorbance per minute of standard 3 , standard 4. IFA,IFB Instrument constants, representing slope and
intercept.
56
(e) Calculation of activity for isozyme measurement channel (Q)
CM={KAM-B-C1}IFA-IFB
C3={KA3- B-C1}IFA-IFB
C4={KA4- B-C1}IFA-IFB
CM: Isozyme M activity of sample. AM: Isozyme absorbance of sample or its change per minute. C3,
C4:each inhibited activity of standard 3 and 4. A3, A4Each inhibited absorbance of standard 3 and 4 or
its change per minute. B: Absorbance of blank or its change per minute IFA,IFB Instrument constants,
representing slope and intercept.
(f) Calculation of activity residual rate
{K (A 3 '-B) + C1} IFA + IFB

=
{K (A 3 - B) + C1} IFA + IFB
{K (A 4 '-B) + C1} IFA + IFB

=
{K (A 4 - B) + C1} IFA + IFB
when C1=0, IFA=1, IFB=0
A3, -B,
=
A3-B
A4
-B
=
A4-B
(g) Calculation of isozyme M activity Cm
CM=CM+CN
CM CM
CM= CF-CN= CF -

CM=CF -CM+CM
-CM= CM-CF
57
C M ' CF
CM=
( )
(h) Applicable assay
1-Point Assay, 2-Point Rate Assay, 2-Point Assay, Rate A Assay.
Note: Suggest operator use 6 calibrators in Logit-log5P, exponential, spline non-linear calibration.
2.2.3 Calibration points

According to the number of calibration points, calibration can be effected in different ways. Blank calibration:
Only reagent blank (standard 1 ) is calibrated. Span calibration: Only one standard solution other than the
reagent blank is calibrated. 2-point calibration: Reagent blank and a single standard solution are calibrated.
Full-point calibration: All standard solutions specified on the Chemistry Parameters screen are calibrated.
These are selectively usable so as to meet your analytical purpose. Each calibration is explained below.
(1) Blank Calibration

Only reagent blank (standard 1) is calibrated. The previously measured working curve is corrected for a
change in absorbance or absorbance change rate (through calculation of S1ABS). Table 2-4 lists the
calculation method for each calibration type. (a) S1ABS calculation
Calibration type SIABS calculation
1 point linearity A11+ A12/2
2 point linearity A11+ A12/2
Multi-point linearity {AU+ A12/2-AU+ A12/2}+SIABS
Isozyme P A11+ A12/2
Isozyme Q A11+ A12/2
Logit-Log 3P {A11+ A12/2-A11+ A12/2}+SIABS
Logit-Log 4P {A11+ A12/2-A11+ A12/2}+SIABS
Logit-Log 5P A11+ A12/2
Exponential function A11+ A12/2
Spline function {A11+ A12/2- SIABS}+aI
Polygon method A11+ A12/2
58
Table 2-4 S1ABS Calculation

A11, A12: 1st and 2nd absorbance values of standard (1) measured presently.
A11, A12: 1 st and 2 nd absorbance values of standard (1) measured previously.
SIABS: Previous SIABS value
aI: I=1~N, N representing the number of standard solution and factor of the curverefer to 5.3.38
Logit-Log 5P method.
This calibration method needs be specified for each test on the calibration test selection screen of Routine
job Menu.
Note*: Only blank calibration can be carried out in case 1 is entered for the number of standard solutions
(K factor method).
(b)Applicable calibration types
Linear (2-point), Linear (multi-point), Linear (1-point: K factor), Isozyme P, Isozyme Q, Logit-log 3P,
Logit-log4P, Logit-log 5P, Exponential, Spline.
(2) Span Calibration

Only one standard solution other than reagent blank is calibrated. The standard solution which corresponds to
the span point entered on the Chemistry Parameters screen is measured and the previously measured working
curve is corrected for its slope. Table 2-5 lists the calculation method for each calibration type. This calibration
method need be specified for each test on the Calibration Test Selection screen.
(a) K factor and S1ABS calculation
Calibration type K factor calculation S1ABS
Two-point calibration C2-C1/A2-S1ABS Previous value
Full-point calibration C2-C1/AN-S1ABS Previous value
Table 2-5 S1ABS, K value calculation
C2: Concentration of standard (2)
CN: Concentration of standard N (N represents span point)
A2: Average of measured absorbance values of standard (2)
AN: Average of measured absorbance values of standard (N)
(b) Applicable assay
Linear (2-point), Linear (multi-point),

59
(3) 2-point calibration

Reagent blank and a single standard solution are calibrated. The standard solution and reagent blank, which
correspond to the span points entered on the Chemistry Parameters screen, are measured and the previously
measured working curve is corrected for S1ABS and slope. Table 2-6 explains the calculation method.
(a) K factor and S1ABS calculation
Calibration type S1ABS Calculation K factor calculation
Two-point linearity A11+ A12/2 C2-C1/A2-S1ABS
Full-point linearity AU+ A12/2 CN-C1/AN-S1ABS
Table 2-6 S1ABS, K value calculation
A11, A12: 1st and 2nd absorbance values of standard (1) measured presently.
CN: Concentration of standard N (N represents span point)
A2: Average of measured absorbance values of standard (2)
AN: Average of measured absorbance values of standard (N)
A1: Average of measured absorbance values of standard(1)
(b) Applicable assay
Linear (2-point), Linear (multi-point),
(4) Full-point Calibration

All standard solutions (including reagent blank) specified on the Chemistry Parameters screen are calibrated.
After this calibration, all working curve parameters S1ABS,K,a,b and c displayed on the Calibration List
screen are updated.
(a) Calculation formula
The calculation varies from the calibration methods.
(b)Applicable calibration types
Linearity (multi-point),Isozyme P, Isozyme Q, Logit-log 3P, Logit-log 4P, Exponential, Spline
60
2.3 Check of measure value
Various checks are performed to enhance the reliability of measured results. Below are check description
2.3.1 Calibration check

(1) Blank level check
In calibration, a warning level alarm is issued if the measured absorbance of blank is not within the input
range of standard 1 absorbance. In this case, the result of measurement and alarm (S1ABS) are printed out.
To avoid check, enter--3.33.3.
(2) Discrete check
A warning level alarm is issued if the difference of the two times measured absorbance value is larger than
the set value. In calibration, each Calibrator (include reagent blank: Calibrator 1) is tested twice.
To avoid the check, enter3.3.
Discrete check is performed by the below formula:
Absorbance Discrete CheckABS
(3) Sensitivity check
If the difference of standard absorbance (average between 2 times measure) from Max. concentration
standard absorbance (sensitivity) exceeds the permissible absorbance sensitivity value (Sensitivity Limit), a
warning- level alarm is issued. In this case, alarm mark is printed out together with the result of
measurement.
The working curve of the alarmed analytical item will be renewed, and the K value wont be renewed. To
avoid the check, enter-0.
Check the permissible sensitivity by the below formula:
ASTDN ASTD1
lower lim it upper lim it
C STDN C STD1
(4) K factor check
If the fluctuation in factor K value between previous calibration and current calibration is 20% ,a warning
level alarm is issued. The working curve and K factor will be renewed and testing can be carried out. Make
sure check the reason of alarm.
Check the K factor by the below formula:
61
K this K last
100% 20%
(K this + K last ) / 2
(5) Drift rate check
In calibration, a warning level alarm is issued if the difference between the calculated absorbance and
tested absorbance has exceeded the drift rate set value. The working curve and K factor will be renewed and
testing can be carried out. Make sure to check the reason of alarm. To avoid the check, enter3.3.
2.3.2 Absorbance of reaction limited check

As to the Rate assay, correct data wont be obtained when concentration or activity exceeds the quantitative
span. Thus, set the upper limit value and lower limit value of the absorbance, print the alarm sign. Input the
calibration value on the screen. To avoid the check, enter-0 (decrease) or 3.3 (increase).
When 4 or more than 4 tested absorbance value is not accord with the set value of reaction limit absorbance,
alarm is issued as figure 2-21 shows:
ABS
Time
Input photometry range
Figure 2-21
2.3.3 Linearity Abnormal Check

In the rate assay, relation between absorbance change and time should be Linearity. Thus, check on the
linearity is a necessity.
Select Linearity check in Alarm Info., and input the limit check value in corresponding textbox as figure
2-22 shows:
62
Figure 2-22
If not selected, even if input value in textbox, linearity check is not carried out.
(1) When number of measurement points (N) more than 9 (N>9)

Linearity is checked by dividing the difference in absorbance change between the first and last 6
measurement points by the average absorbance change for all. If the value thus obtained is beyond the limit
linearity value, alarm is printed out together with the result of measurement as figure 2-23 shows:
Af Ab
A 100Limit linearity value%
Figure 2 23 Linearity check N9
(2) When number of measurement points (N) between 4 and 8 4N8
Linearity is checked by dividing the difference in absorbance change between the first and last 6 measurement
points by the average absorbance change for all. If the value thus obtained is beyond the limit linearity value,
alarm is issued as figure 2-24 shows:
Af Ab
A 100Limit linearity value%
63
Figure 2-24 Linearity check4N8
2.3.4 Prozone check

In immunoreaction, working curve descends if antigen concentration is abnormally high beyond the suitable
range (prozone area). This is called prozone or zone phenomenon.
This instrument can check whether concentration is in the absorbance decreasing range (post zone). For
prozone check, the following 2 methods are available: antigen readdition method in 1-point assay with prozone
check and reaction rate method in 2-point assay. To Avoid check, input -3.3 lower limit in checkup value
function box in analyze parameter menu.
(1) Antigen supplement method:

Take 1-point essay for example, measure reagent 1, and take its value as reference value. Replace reagent with
serum diluents, which contain antigen, add 20ul. Compare the prozone limit value with absorbance difference
(before add reagent 2 and after add reagent 2).
Input method:
Prozone check value (PC value):
Upper /lower limit:
Analytical method:
Photometric point: Q1 Q2 0 0
1Q1Q249
Aq 2 + A( q 2 1) Aq1 + A( q1 1)
PC = k
2 2
64
K=total liquid volume when test q1/total liquid volume when test q2
When 1Q1Q24 or 5Q1Q216, 17Q1Q231, 32Q1Q249 K=1.
AQ1,AQ2: absorbance of photometric point:Q1,Q2
Figure 2-25 Antigen supplement method
(2) Reaction speed ratio method:

Take 2-point assay for example, the ratio between average reaction speed and reaction speed with serum
(prozone check value: PC value), then compare the PC value with prozone limit value.
Prozone checkup value(PC value)
Upper/lower limit:
Analyze method:
photometric point: q1 q2 q3 q4
5q1q249,5q3q449
( Aq 4 Aq 3) /( q 4 q 3)
PC = 100
( Aq1 Aq 2) /( q1 q 2)
photometric point: Aq1,Aq2,Aq3,Aq4: absorbance: q1,q2,q3,q4
photometric point q1,q2,q3,q4 test time point:q1,q2,q3,q4
Do not carry out prozone check when following condition occur:
test point: q1=q2=q3=q4

65
test for No.1 standard liquid (reagent blank)
Figure 2-26 explains antigen supplement method:
Figure 2-26 Reaction speed ratio method
2.4 ISE testing principle
2.4.1 Operation principle

After analysis, SIP injection pump aspirates 65uL reference liquid first and discharges into reference electrode
liquid line, the sample probe aspirates 15uL sample and discharges into diluting cup where DIL injection pump
infuses 450uL diluent, then, SIP injection pump will aspirates the diluted sample and discharge it into electrode
liquid line for the determination of its potential, thereafter, the remaining diluted sample is sucked out by a
vacuum nozzle, sequently, IS injection pump infuses 600uL internal standard solution to the diluting cup for
cleaning Cup, which will be sucked away by the vacuum nozzle. IS injection pump injects 450uL internal
standard solution into diluting cup, SIP injection pump aspirates 65uL reference liquid first and discharges into
reference electrode liquid line for the determination of its potential, and the redundant internal standard solution
is pumped by the vacuum nozzle to empty the diluting cup for the next round of testing.
2.4.2 Electric potential generation principle

The electric potential is calculate by Nernst formula.
RT
E = E 0 + 2.303 l og(ai ) (1)
nF
ai = f Ci . (2)
E 0 : Standard electrode potential of tested system
R: Gas constant8.314510 J*mol-1*K-1
66
T : Absolute temperaturet+273.15(K)
F : Faraday constant9.6485309104C* mol-1
ai : Ioniactivity
f : Activity coefficient
Ci: Concentration
n: electric charge of given iconCation is positive, Anion is negative
2.4.3 Test method

The following procedure explains the preparation of working curve, the test of internal standard liquid
concentration, calculation of concentration, and result revision.
2.4.3.1 Working curve preparation

Test low concentration slope liquid (S1) and high concentration slope liquid (S2), set the slope (sensitivity) of
K,NA, Cl electrode.
E ( H ) E ( L)
SL = (3)
C(H )
log
C ( L)
SL: Slope
E(H): Electrode potential of high concentration slope liquid
E(L): Electrode potential of low concentration slope liquid
C(H): Concentration value of high concentration slope liquid input value 0
C(L): Concentration value of low concentration slope liquid input value 0
2.4.3.2 Internal standard liquid concentration test

Test the concentration of internal standard liquid when working curve prepared.
E ( IS ) E ( L )
C ( IS ) = C ( L) 10 SL
(4)
C(IS): Concentration of internal standard liquid
E(IS): Electrode potential of internal liquid.
2.4.3.3 Concentration calculation.

67
Make internal standard liquid concentration as reference value, calculate basic sample, emergency sample, QC
product concentration. The internal standard liquid is tested according to different sample.
E ( S ) E ( IS )
C ( S ) = C ( IS ) 10 SL
.(5)
C(S): Sample concentration
E(S): Sample electrode
2.4.3.4 Result revision

Test Calibrator (S3) after calibration, and the calculate the concentration, make the difference between test
concentration and input value as compensation value, and add/ subtract the sample concentration of standby
sample.
C (VALUE ) = C (C ) C ( X ) ..(6)
C(VALUE): Compensate value
C(C): Input value of serum Calibrator concentration
C(X):Measure value of serum Calibrator concentration
C ' ( S ) = IF {C ( S ) + C (VALUE )} (7)
C(S):Sample concentration after revision
IF: Instrument constant1.0
.4.3.5 Standard specification of ISE
Item Specification
Sample syringe 15ul
Diluent liquid volume 450ul
Capacity 80 sample/houronly for electrolyte test
Na 20~200mmol/Lonly for serum test
10~400mmol/Lfor urine test
Range K+ 1.0~15.0mmol/Lonly for serum test
Cl- 20~200mmol/Lonly for serum test
68
Internal standard liquid 1050ul/sample (only for electrolyte continual test)

Reagent consumption
Diluent 450 ul/sample
volume
Reference electrode liquid 130 ul/sample
Table 2-7 ISE standard specification

Note: During operation, if ISE analysis is not taken more than 10 minutes, the internal standard liquid will be
pipetted once in order to activate electrode.
69
Chapter 3 Instrument Installation

Analyzer has passed all tests before transportation. Packing it gently in order to avoid damage while
transportation. To make sure normal operation, install or initialize the SAPPHIRE 800 only by authorized staffs
from Audit Diagnostics Company.
3.1 Installation requirement
Due to the relatively large weight of the instrument itself, so it should be installed at the level of the ground, do
not install on the surface of desktop and other objects.
Before installation, operator should check the space, power and environment requirement.
3.1.1 Space Requirement

To make sure the space of maintenance, please follow the instruction as below:
Space between left (right) side of analyzer and the wall should 50cm
Space between rear panel of analyzer and the wall should 50cm
Space in front of analyzer should100cm
Make sure there is enough space for waste device and purified water equipment.
3.1.2 Environment requirement

Operate or store the analyzer according to the following requirement:
Working environment: 1532
Relative humidity: 40 85
Atmospheric pressure: 76kPa106kPa
Environment should with no dust, no mechanical vibration, no noise source and power interference.
Do not put the analyzer in the vicinity of brush motor, flicker fluorescent tube and other constant on-off
electrical equipment.
Avoid direct sunlight, do not put the analyzer in front of heat source and wind source.
The maximum voice at the distance, 1 meter, around the equipment shall be 40dB when it normally works.
3.1.3 Power requirement:

Power supply: ~220V\230V, 50Hz
Power: 2000 VA
Circuit breaker: 250V, 20A
70
A well grounded power supply socket is a must. (Socket at least with one 15 A and three 5A). Large
electrical appliance such as air condition, refrigerator, even cannot use the same electrical wire as analyzer.
Instrument is equipped with a three core electrical wire, red wire is live line, blue wire is zero line, and
yellow green wire is ground lead. Three-core power cord rated temperature: 70 . As figure 3-1 shows:
HO
Figure 3-1
For reliable analyzing, the switchboard should provide with at least 20A, and at least there should be a
20A switchboard for analyzer, three 5A sockets for the display, host and printer. Other electrical equipments
with large loads, similar to air conditioner, refrigerator, oven, should not be connected to the same socket.
In order to realize reliable connection between analyzer and power supply, do not use a power supply
socket but a switchboard when installing the power connection of analyzer. Make sure no much distance
between switchboard and analyzer for convenient for cutting off the power once emergence occurs.
Note: The unqualified environment may cause test value inaccuracy, analyzer damage and it is also
harmful to human body.
3.2 Open package
3.2.1 Procedure
Check if there is a physical damage on the packing when analyzer arrived. If yes, contact Audit
71
Diagnostics company or local distributor. If not, open the package according to below procedure.
Make sure that arrow on the package is up, upright the package.
Open the accessory box and mainframe box, check if parts in box are complete, if not, please contact
Audit Diagnostics company or local distributor.
Check the packing and appearance of the analyzer, if there is a damage, please contact Audit
Diagnostics company or local distributor.
3.2.2 Transportation method

Do not move analyzer until discharge liquidoperation finished. For detailed operation please refer to
12.4.8.
Only push the analyzer in short and smooth distance.
Protect the display screen and sample probe of front panel from outside force while transportation.
Make sure analyzer stands upright, no slope, no side lay.
Avoid vibration while transportation, check and debug the analyzer after transportation.
3.3 Installation procedure
3.3.1 software installation

Install hardware only by professional staff of company. Do not disassemble the analyzer except normally
system maintenance.
Install software only by professional staff of our company. User is not allowed to uninstall software unless
abnormality occurs. Uninstall the software according to the following procedure:
Put SAPPHIRE 800 applied software into CD-Rom, click setup.exe file, installation program initialize as
figure 3-2 shows:
72
Figure 3-2
Figure 3-3
Click next button in figure 3-3, a software select window of install folder will pop up. The default
destination folder is C:\Program Files\Changchun Audit Diagnostics Industrial CO., LTD\SAPPHIRE 800
Auto-Chemistry Analyzer. User could revise installation path by click self-defining button as figure 3-4
shows:
Figure 3-4
73
Figure 3-5
Click install button in figure 3-5, initialize the software as figure 3-6, 3-7 shows:
Figure 3-6
74
Figure 3-7
Click finish button in figure 3-7 to complete the installation process.
3.3.2 Connection of peripheral equipment

3.3.2.1 Connection of pure water pipeline
Connect the outlet interface of pure water supplier and the pure water inlet interface of the analyzer.
3.3.2.2 Connection of waste liquid outlet pipeline

a) Outlet pipeline of concentrated waste: connect one end of the concentrated waste pipeline taken with the
analyzer with the concentrated waste liquid outlet interface ( in figure 1-3), and place the other end into the
waste liquid collector.
Note: please deal with the waste liquid under the local rules and laws.
b) Outlet pipeline diluted waste: connect one end of the concentrated waste pipeline taken with the analyzer
with the concentrated waste liquid outlet interface( in figure 1-3), and place the other end into the waste
liquid collector.
c) Connection of liquid level sensor of concentrated waste solution: connect one end of the concentrated waste
pipeline taken with the analyzer with the concentrated waste liquid outlet interface( in figure 1-3), and place
the other end into the waste liquid collector.
3.3.2.3 Connection of computer

Connect one end of the communication cable taken with the analyzer with the interface of RS-232 in the
analyzer, and place the other end into the concentrated waste liquid collector.
3.3.2.4 Printer installation
75
Make sure do the following checkup before print:
(1) Check if install the driver of printer.
(2) Check if data line is connected well between printer and analyzer.
(3) Check if there are papers in printer, printout after turn on the switch.
3.3.3 System login

After installation, following power supply need to be got through:
General power supply of the instrument, analytical system, computer host, display of computer and printer.
Then, click the icon on computer screen or click start-up, then find the software SAPPHIRE
800 in program and click it, after that, enter system logging window as the figure3-8 and 3-9 show.
Figure 3-8
Figure 3-9
Input user name, password, click login to get into the main menu of software, as figure 3-11 shows: click
76
back cancel login.( Initial user name: 001, password: 001)
Figure 3-11
After successfully login, the software show as offline state, browse menu, check alarm information, user
logout function can be used at this state. Click on-line button, user could then process all browse and testing
operation.
If the wrong user name and password is inputted, a hint form will pop up, as figure 3-12 show:
Figure 3-12
If 3 times failed consecutively the user name and password, the program will exit automatically.
The function keys in the figure3-11 are described as following:
a) Connection: in figure3-11, click , connecting will show, after success of access, the status
77
bar will display sleep. At this time, all operation and tests can be carried out.
After logging, the instrument partially connected or not connected the cable, click the Connection, the screen
will show as figure 3-13 shows.
Figure 3-13
If this shows on the screen, connect after get the power supply connected.
b) Exit system: In the window as figure 3-11 shows, click , enter window figure 3-14 shows:
Figure 3-14
Click yes in figure 3-14 to exit software.
Only exit system at off-line state. If analyzer is on-line, click offline button to exit system, dormant could be
carried out when analyzer stand-by.
Note: In order to prevent data from being damaged or revised by other people, exiting software when
doctor takes a rest is strongly suggested. Periodically backup database in order to avoid data lose.
Input initial user name and password when first login, select user information in management
menu, set user name, password and access authority for next time login.
The analyzer will be in sleep status after 20 mins of power on (waiting for the stability of power and
temperature).
3.3.4 Uninstallation of software

If the uninstallation of applied software of full-automatical chemistry analyzer of SAPPHIRE 800 is needed,
please enter addition or cancel program in setting board, click cancel button, window addition or cancel
program will pop up. Then window like figure 3-15 will show:
78
Figure 3-15
In the figure 3-15, click Yes to complete the uninstallation.
Chapter 4 Accessory Device
4.1 Sample disk barcode reader
4.1.1 Scan range of barcode reader

Barcode reader on sample disk is used to identify barcode of 1-50 sample positioned on the outer track of
sample disk.
4.1.2 Container requirement

(a) Specification: cuvette: 10mm75mm,10mm100mm,13mm75mm,
13mm100mm(1 mm),
Standard cup: 14mm37mm(1 mm)
(b) Orifice of the cuvette should be regular. Deformation and extrusion is not allowed.
4.1.3 Barcode requirement

(a) Type: Code bar,code 128,code 39,code 93,12of5,UPC/EAN
(b) Size: Blankness between start and finish line should within be 3mm when cutting barcode as figure 4-1
show:
Width
Start blank Length End blank

Figure 4-1 Blank and length
(c) Digit of different barcode types
Sample barcode type Digit

Code39
510
Code93
412
Code128
522
79
12of5
415
UPC-A 11
UPC-E 6
EAN-8 7
4.1.4 Stick requirement Figure 4-1

(a) No cockle, no contamination one the label, no line deformity when stick barcode , otherwise the barcode
reader cannot correctly read the barcode.
(b) Stick barcode on correct place:
In order to obtain correct barcode, 15mm-20mm between cuvette bottom and barcode lower line is required.
Make sure barcode is on the outer side of sample disk when place on the test tube rack., as figure 4-2 show:
Barcode
Figure 4-2
When the CODE39 is not capitalized, please add + before the corresponding capitalized letters of the ID
code displayed on the screen and the report sheet printed after scanning.
Note: the , , ( ) are not allowed for the barcode, or it cannot be identified.
4.1.5 Barcode reader checkup

When test startup, sample disk will stop turning on barcode reader position, and then barcode reader will read
barcode. If barcode is not identified correctly, the barcode reader will repeat scanning three times. Sample
supplement cannot be taken when scanning, it can be taken only after scanning. If scan sample barcode is set,
sample probe will stop sampling operation, sample disk will turn to barcode reader position, start scanning.
Sample disk turns to sampling position when scanning finish. Scanning information will be showed in sample
register and test result menu.
Barcode reader will continually identify 1-50 sample on outer track of sample disk when processing barcode
reader checkup, and the scanned information will be showed in maintenance menu.
?? means no effective barcode exist.
4.2 Reagent barcode reader
4.2.1 Scanning range

Barcode reader on reagent disk is used for identifying barcode on reagent disk 1 and reagent disk 2.
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4.2.2Reagent bottle requirement

Specification: 70ml, 20ml.
4.2.3 Operation requirement
(a) Type: Code 12817 digit
(b) Size: width within: 12mm-15mm, length within 40mm. As figure 4-1 show.
(c) Blankness between start and finish should within be 3mm when cutting barcode as figure 4-1 show.
4.2.4 Stick requirement

(a) Stick the barcode with no cockle, make sure there is no deformity on barcode line. Contamination is not
allowed on label, or barcode cannot be read correctly.
(b) Stick the barcode on the correct place.
Blankness between bottle bottom and barcode should be within 15mm-25mm, thus barcode could be read
correctly.

Carry out barcode scanning in reagent info. menu, reagent barcode reader will continually scan on the two
reagent disks twice. If barcode cannot be identified while scanning, barcode reader will repeat scanning three
times
When checking reagent barcode reader in system maintenance, reader will identify barcode info. and
display the scanning result of R1, R2 reagent disks in the window system maintenance.
?? means no effective barcode exist.
4.2.6 Reagent barcode rule

Reagent barcode information can only be read by barcode reader, the information will coupling with chemistry
parameter which stored in instrument, and this process is called reagent registry information. Reagent
information registration could check reagent position on reagent disk.
The read information could be showed in reagent information menu as disc No., position, reagent
name, reagent type, remaining reagent volume, remaining test No..
Reagent name: Chemical name of analyze item.
Position: Each reagent disk has 1-45 positions, 1-44 are used for place reagent, and 45 position is specially
used for place CS-anti-bacterial phosphor-free detergent.
Note: Regular clearing of the reading window of sample disk and reagent disk barcode reader is required.
User can prepare with their own barcodes according to circumstances. Rules are as shown in Table 4-2.
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Detailed explanation
Barcode
Information Barcode range of barcode Remark
digit
implication
Biochemical reagent
0~94 item code ( represent
different item name)
ISE- Internal standard
95
solution
96 ISE- Diluent
1~2 Item name ISE- Reference
97
solution
CS-antibacterial
98 phosphor-free
detergent
99 CS-alkaline detergent
1 20ml
2 70ml
Bottle
3 3 100ml
specification
4 500ml
5 2000ml
1 R1
2 R2
3 R3
4 Reagent type 4 R4
Reagent type reagent
should be 5 if item code is
5 No
ISE reagent or CS Series
cleaning liquid.
0~9 Year
Production
5~9 01~12 Month
date (Lot)
01~31 Day
1 2 weeks
2 1 month
3 3 months
4 6 months
10 Expiry date 5 12 months
6 18 months
7 2 year
8 3 year
9 5 year
11~14 Bottle code 0001~9999 The XXXXXth bottle
Numeric or alphanumeric
15~17 Parity bit
(automatically generated)
Table 4-2
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4.3 Purified water equipment
Instrument consumes 25L/h water at peak value. The purified water equipment should meet the following
requirement:
water should be obtained from tap water pipe
water conductivity should within 1uS/cm
water supply volume should reach 40L/h or more
The hydraulic pressure should within 49-343 Kpa
Note: To use/maintenance the purified water equipment, please refer to user manual, or consult the distributer or
manufacturer.
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Chapter 5 SAPPHIRE 800 Software Operation
5.1 Software interface instruction
5.1.1 Main interface composition

The main menu of software is composed of status bar, main function keypad, workspace, software
information.
(a) Status bar: Shows display status on the top of menu. As figure 5-1 shows:
Figure 5-1
Description:
: Represent display status: stand-by, testing, emergence stop, sampling stop, maintenance
operation, sleeping mode.
: Communication monitor mark. When communication is under normal status, the icon turns blue, when
communication abnormal, the icon turns black. Once the icon color turns from blue to black, that indicate
communication failure.
: Alarm icon. This icon occurs in status bar when alarm is issued. Click the icon, start alarm checkup,
solve the problem according to the remedy.
: Display temperature of circulating water in incubation bath, regular water temperature is

within 370.1. Alarm issued when temperature above 45. Alarm also occurs during test status.
: Display ID information of current user. To setup, change or remove the

information, click user information in management menu.
: Display computer system time (year-month-day week hour-minute-second).

Click time and date button to change time and date.
(b) Main function keypad: Select menu by single mouse click. Single click on corresponding function key, the
border will change color correspondingly. As figure 5-2 show:
84
Figure 5-2
(c) Working space: enter specific operating space, as figure 5-3 show. Single click corresponding function key
enter working space menu, the border color change correspondingly.
Figure 5-3
(d) Hint bar: instruct user how to use software, hint the input range, input method, operation error, as figure 5-4
show:
Figure 5-4
(e) Shortcut key space: for convenience use, as figure 5-5 shows. Single mouse click on corresponding function
key or press F2-F9 on keypad.
Figure 5-5
85
(f) Software information space:
Click key to display edition information of software. Edition No.: 1.20. As

figure 5-6 show. This form is a mode form, click ok key to close.
Figure 5-6
5.1.2 Keypad function

(a) Num Lock
This button is used for checking if number keypad is open.
(b) Caps Lock
This button is used for switch letter case.
(c) Function key
F1 Software help shortcut
F2 Start analysis shortcut
F3 Sampling stop shortcut
F4 Emergence stop shortcut
F5 System monitor shortcut
F6 Alarm information shortcut
F7 User log-out
F8 Exit system shortcut.
86
5.1.3 Software function frame
Sample test Edit sample, doctor, patient test information
Delete result, result query, review, preview, audit, print, batch print, batch
Test result print, reaction curve
Reagent Info Manual registry, remove reagent info, barcode scan, reagent level
Calibration registry Calibration registry type and item

Calibration
Information
Calibration result Calibration data and reaction curve.
QC registry QC registry and parameter setup
QC control QC interval Analyze QC test data
Chart monthly Analyze QC data in one month
Parameter Analyze, calibration, range parameter

SAPPHIRE 800 Automatic Chemistry Analyzer
Item combination Edit item combination information
Calculate item Edit calculation item information
Cross infect Cross contamination avoiding
System setup Report format Report Info, print sequence, print format setup
ISE setup ISE parameter setup
System setup Barcode, ISE, time awaken setup.
Manual item setup Add manual item.
LIS setup ISE communication setup.
Reagent setup Reagent fill setup.
User Info. Operator ID, name, password, access authority.
Hospital info Test delivery department and doctor.

Sample type, patient type, clinic
Other Info. diagnose, report remark,item unit.
System
Management Workload statistic
Database backup and restore
System log Login, maintenance, operation, alarm log

System
Maintenance Periodical maintenance and checkup
87 System help Provide help to user

Figure 5-7
5.2 Software Operation
Select function key of software by single click mouse button. Input value and character combine with keypad
(switch by shift + control, input method is depend on windows system).
5.2.1 Cursor move

Cursor moves as single mouse click on target input space or target item.
5.2.2 Function key select
Select function key by single mouse click.
5.2.3 Open Form

In order to open form, click function key corresponding to form. Form is divided into mode form and modeless
form.
Mode form: other menu cannot be opened until mode menu is closed. Click exit or close button to exit. As
figure 5-8 show:
Figure 5-8
Modeless form: other menu can be opened when modeless menu open, system will automatically close last menu
88
when other menu is opened. As figure 5-9 show:
Figure 5-9
5.2.4 List box and scroll bar

(a) List box
List box is used for displaying a information. List box is also used for finding and selecting needed
information from displayed information. As figure 5-10 shows:
89
Figure 5-10
(b) Scroll bar
Scroll bar is used for adjusting display range in list box. Scroll bar is divided into longitudinal scroll bar and
horizontal scroll bar. As figure 5-10 shows:
5.2.5 Pull-down menu

Click on the right side of menu to open or close pull-down menu. More information can be showed in
pull-down menu. Once select, the selected item can be showed on the top column, and pull-down menu
disappears at the same time.
5.2.6 Button box and Check box

Button box: only one function can be chosen between two functions, as figure 5-11 shows:
Figure 5-11
Check box: more than two functions can be chosen at the same time, as figure 5-12 shows:
90
Figure 5-12
91
5.3 Instrument standard specification
Performance index Standard specification
Plat image grating spectra photometry system, photometry by 12 wavelength.

Wavelength range
Wavelength: 340 , 380 , 405 , 450 , 480 , 505 , 546 , 570 , 600 , 660 , 700 , 750nm
Wavelength precision 2nm
Basic Reaction temperature 370.1
feature Test item Reagent open, 88 colorimetry test, 3 ISE item can be taken at the same time.
Measure method End point essay, Rate essay,turbidimetry
Constant speed 400 test /hour, SAPPHIRE 800A/B speed 800/1000 tests /hour with
Measure speed
ISE
115 position (basic sample: 50, standard product: 34, emergence sample 20),
Sample disk,Sample position
QC product: 8, detergent:3
R1, R2 cooling reagent disk, each reagent disk conclude 45 reagent position (45
Reagent disk,Reagent position
position is special for placing CS-anti-bacterial phosphor-free detergent).
Sample
Sample barcode identify system 3 build-in barcode reader (basic sample, reagent 1, reagent 2)
system
Sample type Serum, blood, urine, cerebrospinal fluid, ascetic fluid
Sample volume 235l
Sample liquid level sensor Integrate with sample probe.
Reagent volume 20350l
Reagent Reagent bottle volume 20mL ,70mL

system
Reagent restore temperature Temperature within 515, adopt semi conducting cooling
Reagent liquid level sensor Integrate with reagent probe

Reaction cuvette type Discrete system
Reaction cuvette optical diameter 6mm
Reaction position 6sets(20), total :120
Reaction time No more than 15 minute3, 4, 5, 10, 14 minute can be setup.
Analyze Reaction liquid volume 150450l

system
Light source 20W/12Vlong life quartz halogen lamp
Absorbance range 03.3Abs
Quality control QC interval, Monthly QC

Automatic rinsing Rinsing cuvette automatically.
Stirring rod mechanism Singleness stirring after reagent adding
Data Interface TCP/IP interface, standard RS-232 and USB2.0 interface
92
system Printer stylus printer, support user-defined mode

Connect with LIS/HIS system Connect with LIS/HIS system
Weight About 300Kg
Ntegrated
size 1060 mm790 mm1150mm(lengthwidthheighth)
Equipment
system Power consumptionVA 2000VA
Figure 5-16
Note: according to different test condition, sometimes instrument processing capability is lower than 400
test/hour
Test condition Processing capability lower degreeestimated
Test after sample diluent 133tests/hourtest under pre-diluent condition
At least 200test/hourreaction cuvette,sample probe

Cross contamination avoiding function
200400test/hourreagent probe
R1-R4 test At least 200 test/hour
Figure 5-17
93
Chapter 6 Instrument Operation
6.1 Overview of operation
Table 6.1 shows the operation flow. For detailed operation, please refer to table 6.2.
Form / function Consult

Operation step Operation
key index
1. Check before operation Check before turning on power 6.2.1
2.Connect water unit and turn on Open water faucet, turn on the power of purified
SAPPHIRE 800 power water unit and SAPPHIRE 800 6.2.2
Software login System Login Input operators ID No. and password.
3. Check instrument status
1 Check alarm Alarm information Please refer to chapter 13 alarm maintenance
Execute light quantity checkup, check if test
value is within regular range
2 Check light quantity of System maintenance Execute cell blank check, check if test value is 6.2.3
photometer within regular range
3 Check cell blank System maintenance Check if temperature of incubation bath is within
37.00.1
4 Check temperature of incubation bath. Status bar
4. Check analytical conditions
1 Item added System setup Add chemistry item
6.2.4
2 Chemistry parameter System setup Check chemistry parameter
3 Check K value Calibration info Check calibration curve and K factor
5. Reagent preparation (reagent info)
1 Check reagent residual volume Reagent info Check reagent remaining volume and remaining
test times. Place the reagent at the corresponding
6.2.5
position on the Reagent disk.
2 Preparation for photometry item and Reagent info
preparation for ISE item
6. Setup of calibration and control item Calibration info Check item name of calibration analysis
6.2.6
and test Quality control Check item name of QC
7. Sample registration and test Sample registration Registry and check sample info, patient info, and
6.2.7
operator info.
8. Start analyze
1 Preparation of sample, standard solution, Put routine sample, standard and control sample
6.2.8
Controls, detergent on sample disk
2 Start test start analyze Execute start analyze.
9. Testing Monitor the instrument when testing.
1 System monitor System monitor
2 Sampling stop/continue Sampling
3 Emergence stop stop/continue 6.2.9
Emergence stop
4 Sample super addition. Sample registry Carry out sample edit when testing and click start
analyze.
To search, amend, delete test result, check sample
10. Check test result (result data) Result data 6.2.10
reaction curve
In recheck form, click start recheck, and send
11. Recheck sample test Test result 6.2.11
the recheck instruction.
12 Completion of analysis
1 Recheck result Test result Check and printout the test result.
2 Database backup System management Periodical backup database, one week is
suggested.
6.2.12
3 System dormancy Instrument could automatic start at specified time
after setting
4 Turn off instrument Turn off instrument, computer, connect water
5 Preparation of next operation unit.
Table 6-1 Overview of the operation process
94
6.2 Detailed operation
6.2.1 Check before measurement

(a) Check power supply and voltage.
(b) Check communication wire and power wire which connecting host computer, instrument and printer.
Make sure the wires are well connected .
(c) Check if print paper is enough, add paper if necessary.
(d) Check if there are water drops, contamination and bending of reagent probe, sample probe and stirring
mechanism.
(e) Check if the detergent is enough. Place CS anti-bacterial phosphor-free detergent at 45th position on R1, R2
reagent disk. CS alkaline detergent in detergent box should be enough, detergent at sample disk W1, W2,
W3 should be enough. For detailed information please refer to 12.1.3 detergent .
(f) Check if waste solution. bottle is empty. Ignore this operation if drainage device is connected with down
pipe.
(g) Check if there are air bubbles in syringes (leakage and air bubble may cause incorrect data).
! Warning :
CS serial detergent is corrosive liquid. In case of skin contact, flush the area with water, rinse immediately
with plenty of water and seek medical advice.
6.2.2 Power on and software login

(a) Turn on the power of purified water, and open the water faucet.
(b) Turn on the power supply of SAPPHIRE 800.The main power switch lies in the right lower side of
instrument. Turn on the switch when there are reagents in reagent disk, therefore the cooling system may
under normal working condition. The power of analyzed part lies in the right upper side of instrument.
(c) Login SAPPHIRE 800 software, make sure carry out online instruction before testing.
6.2.3 Check instrument status

6.2.3.1 Check alarm
(a) Letter display of alarm information
Single-click key in the shortcut area to check alarm. When alarm issues during operation,
the alarm code, level, description and time can be displayed on the screen. (As figure 6-1shows)
95
Figure 6-1
For detailed information, click the information, and the detailed description will be displayed in the textbox
(as figure 6-2 shows).
Figure 6-2
At the same time, the remedy will be displayed simultaneously in remedy textbox (as figure 6-3 shows).
Figure 6-3
(b) Buzzer Hint:
indicates buzzer on, the instrument will make a buzz when alarm issues.
indicates buzzer off. Even if the alarm is issued, there is no buzz.
(c) Alarm icon hint
When alarm is issued, the alarm icon may occur. Click the icon to display the alarm information
form.
(d) Delete alarm information
96
Click key, all the information in the alarm info. form will be deleted. Select one of the
alarm information and click key, the selected information will be deleted.
(e) Alarm information setup. (As figure 6-4 shows)
ISE reagent remaining volume alarm: Setup the lowest test number of reference liquid, diluent , Internal
standard liquid of ISE test.
Sampling stop alarm: Select the function, and alarm will issue when sampling stops.
Linearity check: Input the limit value of Rate assay or linearity assay.
Figure 6-4
6.2.3.2 Check light quantity
Single-click button, select light quantity check option, and click execute button.
Instrument will automatically carry out light quantity check. The light value of current time and last time can
be showed in result column. As figure 6-5 shows:
97
Figure 6-5
Click button to print out the test result.
As light source lamp aging gradually, the check value may increase daily. AD value of all wavelengths should
be less than 18000. If the AD value is more than 18000, please replace new light source according to chapter
12.4.3.
6.2.3.3 Check cell blank
Single-click the key, select cell blank check option, and then click key.
Instrument will automatically carry out the cell blank check. The cell blank value can be displayed in result
column. Click key to print out the test result. (As figure 6-6 shows)
98
Figure 6-6
Cell blank value of the first reaction cuvette should be less than 18000, the difference between cuvettes (the
difference between current one and the first one) should be within 800. When test value out of this range,
please replace reaction cuvette according to chapter 12.2.4.
Before a new reaction cuvette is replaced, immerse it into 2% CS anti-bacterial phosphor-free detergent for
more than 8 hours, and then flush it with purified water before install. Only carry out test when cell blank
value is qualified.
6.2.3.4 Check the temperature of incubation bath

Observe the temperature in status bar on the top of screen, check if the temperature of incubation bath is within
370.1. A warning level alarm is issued when temperature over 370.5, but instrument will continue
analyze at this time. A warning level alarm is issued when temperature of incubation bath over 45 (computer
stand-by).
Note:
After power on, it takes 20 minutes to ensure the constant (370.1) of incubation bath. And it also takes
several minutes to stabilize the light source lamp. Therefore, form information can be browsed, parameter can
be login, alarm info. can be check even computer is not in standby status. Sample testing can be only carried
out after computer stand-by.
6.2.4 Check analyze condition

Setup the analyze item added, chemistry parameter, calibration parameter and control parameter before
99
testing. As to the parameter setup, usage method and storage information, please refer to the user manual or
consult the relative manufacturer or distributor.
6.2.4.1 Check analysis conditions of colorimetric item
1Add / Remove item
Item should be added before parameter setup. Click the key, and its -click the
in form. For detailed operation please refer to chapter 9.1.
Item name and number cant overlap, if the same item of different company is added, please distinguish them
with different letters or numbers. Test takes place in terms of the sequence (from small to big) of item No..
2Check chemistry parameter
Set up/check the reagent chemistry parameter according to the reagent manual. Some parameters are necessary,
such as: test item name, wavelength, test light point, test time, sample volume, reagent volume, reagent
position, reaction type, reaction direction and decimal digits etc. and some parameters are significant to a
reliable test result, such as linearity range, absorbance limit, etc. Strongly suggest the operator input correct
parameter before test.
Click key, then click key. Please setup the chemistry parameter
according to the reagent manual. For detailed operation, please refer to chapter 9.1
3Profile item setup
The function of profile item is to put the relative items together, such as perform the whole set of liver function
or the whole set of kidney function. Use one key to finish many items registration, which is convenience for a
rapid sample registration.
Click key, then click key. For detailed operation, please refer to chapter 9.2.
4Calculated test setup
The function of calculated test is to determine result on the basis of test A, B or more test in order to calculate
test result of a new item.
Click in main function key field, then click key,. For detailed operation,
100
please refer to chapter 9.3
5Cross contamination setup
The function of cross contamination is to decrease or avoid cross contamination among different items. It
includes the cross contamination of reagent probe, reaction disk and sample probe.
Note:
Due to the different reagent formula, the analytical result of other items can be effect. The contamination
degree is different according to varied reagents. For detailed information, please consult the manufacture or
distributor. Strongly suggest the operator setup the reagent which cross contamination may occur separately.
Or through the Cross contamination setup to decrease the cross contamination among tests.
Click key, then click key. For detailed operation, please refer to
chapter 9.4
6Check calibration K factor
If 1 point linearity method is used for calibration, Click key, then click calibration result key,
as figure 6-7 shows.
Figure 6-7
101
Input K factor in column, and click key .
6.2.4.2 Check analysis conditions of ISE item
1Activate ISE
If the instrument has equipped with ISE module, please activate ISE in system setup form first, then carry
out ISE test. means ISE is activated. And means ISE is not
selected, all ISE function cant be used.
If sign in washing after test, sample probe will assimilate the CS-ISE detergent (locate in W2 position
of sample disk), then rinse the diluent bath and ISE pipeline. This operation wont take place if it is not
selected.
Click save key after setup.
2ISE parameter setup
Select item name and sample type in ISE setup menu. In calibration parameter work area, select Calibrator
position from the pull-down menu, input the concentration of Calibrator. There are three kinds of Calibrators:
low concentration, high concentration and blood sample. 15ul is a fixed sampling volume of Calibrator, there
is no need to set again. Input the reference range, linearity range, decimal digits, QC interval (default value:0.
input interval time if needed), slope and intercept, and then click save parameter key, as figure 6-8 shows:
102
Figure 6-8
Note : The sample volume of ISEis fixed, 15ul, and no set value is needed.
6.2.5 Reagent Preparation (Reagent information)

6.2.5.1 Colorimetric item Preparation
(1) Reagent usage
(a) Reagent confect, use and storage should be performed strictly according to reagent manual. Avoid air
bubbles occur in reagent. Due to the surface active agent of reagent may cause bubbles. And when liquid level
sensor touches the bubbles, it may misjudge it as reagent, thus cause the inaccuracy of sampling volume and
affect the test result.
(b) Dont replenish reagent.
If the added reagent is coming from different plant or different lots of the same plant, it may cause the change
of the reagent component, thus effect the test result.
(c) Turn the reagent knob counter-clockwise, open the lid, and put reagent bottle at the relevant position on
reagent disk. Table 6-10 shows the reagent type:
Reagent type Reagent disk
Reagent 1
Reagent disk1
Reagent 4
Reagent 2
Reagent disk 2
Reagent 3
Table 6-2 Reagent type and Reagent disk
Such as a bar code on the reagent bottle, the bar code labels have confirmed that non-polluting or off.
Note: Diluent is pure water outflow from R1 reagent probe.
! Warning:
Execute resetting process before barcode reading. Sample probe, reagent probe and stirring rod mechanism
will start up later. So please leave the instrument after closing the cover of reagent disk. Dont extend your
hand into instrument in order to avoid body injury.
2Reagent manual registration
(a) Single-click key , and then click reagent information key, input reagent information in
manual registration form as figure 6-9 shows.
103
Figure 6-9
(b) Select reagent disk number and reagent position .
Select 1 (reagent disk 1), 2 (reagent disk 2) in the pull-down menu. Input reagent position from 1 to 44.
Position 45 of both reagent disks is for CS-anti-bacterial phosphor-free detergent. Select reagent name, reagent
type, bottle specification in the pull-down menu, then click register key.
(c) Reagent scanner cannot recognize unclear barcode, to solve this, click barcode key to registry by manual,
input valid barcode in barcode input box, click registration to register reagent information.
Note: Reagent information cannot be only registered or removed under running status.
3Barcode scanning (automatic registration)
Reagent can be automatically registered through barcode scan when barcode information are clear and
complete.
Single-click barcode setup key, input the barcode number and item name, and then click add key, as figure
6-10 shows.
104
Figure 6-10
Select the information to be deleted, then click delete to eliminate the information. Single-click close key
to exit the form.
Click key in reagent info. menu, instrument will automatically scan reagent on both
reagent disk, relative reagent information (such as reagent position, name, type, shelf time, model, batch
number and bottle standard) will be displayed in reagent info. list. When reagent remaining test number is 0,
gray color will appear, when expire, red color will appear. As figure 6-11 shows.
Figure 6-11
105
4Reagent Horizontal
Click key in form, instrument will check remaining reagent volume and
remaining test number, and the test information can be showed in reagent info. list.
Once reagent probe sucked reagent, the remaining reagent volume and remaining test number are tested and
updated.
5Display reagent remaining volume
Single-click Reagent Remains. key in the window Reagent info. as figure 6-12 shows:
Figure 6-12
The reagent name, location, and the remaining amount, the remaining times and such detailed information will
be displayed. In the testing process, so long as the probe sucked reagent kit, it will detect the remaining
amount of reagent, meanwhile, the reagent remainder volume and remaining test times.
6Delete reagent information
Select the information to be deleted by mouse, click key, a delete form will pop up, as figure
6-13 shows.
Figure 6-13
106
Click Yes key, the reagent information will be deleted.
Note:
(a) If the reagent disk cover is open during measuring, a warning level alarm will be issued. Do not open the
cover when testing in order to avoid dangerous and instrument damage.
(b) After reagent information registry, carry out reagent level check before test in order to check the reagent
remaining volume and remaining test number.
6.2.5.2 ISE item preparation

(1) Reagent placement
Open the top cover, place internal standard liquid (IS), diluent (DIL) , reference electrode (REF) in ISE
position at the left side of unit system.
(2) Input remaining reagent volume.
Input the reagent volume of internal standard solution (IS), diluent (DIL) , reference electrode (REF) in ISE
setup Form. Click save button to same parameter. Remaining volume will automatically reduce after
instrument use ISE reagent.
(3) Carry out ISE (all) rinse in maintenance menu . If one reagent is changed, do the relevant rinse.
(4) The reagent wastage (ml) is showed in table 6-3, 6-4:
Power Start Operation Change reagentISE prime

Reagent on up ml/test Adjust
IS DIL REF IS+DIL ALL
Internal 2.4 2.4 1.05 1.05 22.7 10.7 10.7 22.7 22.7
standard
Diluent 1.2 1.2 0.45 0.15 0.2 11.0 0.2 11.0 11.0
Reference 0.9 0.9 0.13 0.065 0.8 0.8 12.8 0.8 12.8
electrolyte
Table 6-3
Reagent ISE check
Internal standard 2.4+0.45*N
Diluent 1.2
Reference electrolyte 0.9+0.65*N
Table 6-4
Note: N is the time of checking.
Note: In standby or test, if there is no command of ISE testing in 10 minutes, the equipment will automatically
carry out "adjustment".
107
6.2.6 Calibration item and QC items registration

(1) Calibration item registration
(a) Click key, select calibration method in calibration pull down menu in
form, and select test name and test item .
The four kinds of calibration methods is showed in Table 6-5:
Calibration Standard solution Object Applied assay Application example

type volume mode
Blank Blank solution renew reagent All calibration K coefficient method, when
calibration blank value methods standard solution test is omitted
Span One point except Renew k value Two point linear, Recheck standard solution point 1
calibration of blank solution multi-points linear
Renew reagent Linear 2 points method finish

2 points Blank solution and blank value and Two point linear, standard curve.
calibration span points K value multi-points linear Multi-point method, omitted the
quantity of calibration solution
Multi-point linear,
Full points All concentration Renew standard isozyme Q , Multipoint standard curve, isozyme
calibration registered curve by all isozyme P , method
points nonlinear working
curve calibration
Table 6-5
(b) Select calibration item in test item work area. Sign in the function block by single-clicking mouse,
show as: , double-click to cancel it, and is showed.
(c) Click calibration register functional key, the registered item name and item type will be displayed in the
browse area. In order to check the concentration and position of calibration item, single-click the desired item
name, the calibration parameter will be displayed in the right side. As figure 6-14 shows:
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Figure 6-14
(d) Delete the calibration item. Select the desired item, click delete key, the item will be deleted.
(e) In order to execute ISE calibration, single-click button, select execute ISE.
(f) Click key to exit the calibration info. menu.
Note: The test item should in execute status, and calibration before analyze.
(2) QC item registration
Click key, register the name, position, batch No. information according to chapter 9, and set
up its target value and standard deviation. Click the "QC test" to send commands to be tested.
Note: QC registration of colorimetry item is the same as ISE item, select it in QC test pull down menu.
6.2.7 Sample registration
Click key, and then check sample info. form. As figure 6-15 show.
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Click to exit.
Figure 6-15
(1) Single sample registration
(a) Input sample number in sample number functional block, or click previous / next key to select the
sample number.
(b) In order to register routine sample, select the sample disk number from 1 to 9 in disk number menu.
Input sample position No. from 1 to 50 in position number functional block. If sample disk number is
changed, instrument will issue stop level alarm, but analysis do not stop. Single-click continue key, sample
probe begin to sampling from new sample disk.
In order to register emergent sample, single-click emergence key, input number 51-70 in position
functional block.
(c) Set up sample type, sample volume, cup type and check date etc. information.
(d) For sample diluting, click dilute key.
Note: If the sample is both dilute item and undiluted item, you must first choose whether to do diluted then
check the item info., click the register sample, then as figure 6-16 shows, complete registering after
confirmed the item info.. If all sample need to be diluted, then choose Always diluent in Analyze
Parameters of system setup.
110
Figure 6-16
(e) Click the item name to be tested by mouse in item information work area. indicate select. Items can
be also inputted the by profile function.
Setup and deletion of compounding item, please refer to chapter 9.2.
Note: After adding items, if not set parameters in "chemistry parameters", the item in "item info." is
grayed-out, can not be choosed.
(f) After editing, click Register sample key. The registered information will be displayed at the right side.
Sample number: Input sample number to functional block, the number is uniqueness, one sample only
has one number in a day.
Barcode number: Barcode number is stick on the outside of sample tube, when scanning, the scanned
value will be displayed in barcode number functional block. If barcode number scanning failure, input the
effective number in barcode number functional block.
Sample type: Select sample type in pull down menu. This function is in other info. of the system
administration form. For detailed operation please refer to chapter 8.3.
Check date: Display the current date.
Repeated test: The test times to same record. The default time is 1, the max. is 100
Dilute: Indicate if sample need to be diluted. Select diluent position in chemistry parameter. Input sample
volume, diluent volume, sample volume after diluting. Dilution function must be selected in sample
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information.
Previous sample: When register or delete sample, sample number decease 1 by single-click mouse
button.
Next sample: When register or delete sample, sample number increase 1 by single-click mouse button.
(2) Registration of batch routine sample
When various samples are registered in same test item, batch sample registration can be used.
Single-click key in sample register menu. enter batch sample registration menu as
figure 6-17 shows.
Figure 6-17
(a) Input the start sample number in the first functional block and the last sample number in the second
functional block of Sample No. range. The last sample number should be large than the first number.
(b) Select the start disk number in disk No. menu, input the beginning position No. (1 to 50) in position .
Sample disk No. and sample position No. will automatically increase from little to large when batch
registration.
(c) Select the relevant info. in sample type sample volume menu.
(d) Single-click item name by mouse , select test item , item compounding function can be used also.
(e) After edit, click register key. If one of batch registration samples is the same as single registration
sample, instrument will remind user that registration failed in hint bar , display as figure 6-18.
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Figure 6-18
Edit the right batch samples again.
(f) Single-click close key to exit the batch registration menu.
(3) Edit the patient info
Single-click key in sample register menu. As figure 6-19 shows:
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Figure 6-19
(a) Input sample No. in sample No. functional block, click Previous Next key to choose sample No.
(b) In functional block, choose or input patient name, age, gender, case history No., patient type, delivery
dept. , delivery doctor, bed No., Check doctor, audit doctor, delivery date, clinic diagnoses and remark etc.
Patient name must be input when edit patient info.. Or instrument will refuse registration.
(c) Single-click patient registration key, patient name will be automatically displayed in the browse area.
(d) Single-click sample info. key enter the menu. Click close key to exit the menu.
Age: Select age from pull-down menu: year, month, day, and time. And then input numbers.
Patient type: Select clinic, medical insurance, hospital, physical exam in pull-down menu. This
function can be setup in other info. of menu. For detailed operation, please refer to
chapter 10.3 .
Dept.: Select the type of sample delivery dept. in pull-down menu. This function can be setup in hospital
info. of menu. For detailed operation, please refer to chapter 10.2.
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Doctor: Select the doctor name. This function can be setup in hospital info. of menu.
For detailed operation, please refer to chapter 10.2.
Auditor: Select the doctor name. For detailed operation refer to chapter 10.1.
(4) Modification and deletion of sample information
Single-click the desired item in browse area, or click previous next key to choose the right sample, or
directly input the sample number to be modified in sample No. functional bock, then click OK key to edit
new information, click sample registration key to enter overlay confirmation menu. As figure 6-20 shows.
Figure 6-20
In order to delete sample, click key in sample info. menu, as figure 6-21 shows:
Figure 6-21
In the left functional block, input the start sample No. to be deleted. Input the end sample No. in the right one.
For deleting one piece of information, input the same sample No. in the start and end functional block. The
start sample No. should be less than/equal to the end No..
Note 1: Registered sample (Not yet test) can be modified or deleted during stand-by and operating.
Registered Sample (Already test) cannot be modified or deleted during operating.
Note 2: Operator can register sample info. firstly, then register patient info.
6.2.8 Test preparation

(1) Prepare routine sample, Calibrator, Controls and detergent.
Place routine sample, Calibrator, Controls and detergent. in the relevant position on sample disk.
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(a) Detergent placement .
Test colorimetric item, place CS-alkaline detergent in the position of sample W1 disk, test ISE item, please
place CS-ISE detergent in the position of sample W2 disk, avoid crossed contamination, place CS-acidic
detergent in the set position.
(b) Calibrator placement
According to the Calibrator position, which is set in chemistry parameter, place the relevant Calibrator in
middle or inner track of sample disk.
(c) Placement of controls
Place the relevant QC sample in inner track in terms of the QC position set in QC registration menu.
(d) Sample placement
According to the routine sample registration position of sample register menu, place routine sample in
positions 1 to 50 of outer track, and place the emergency in the positions 51~70 of middle track.
Note: QC sample and Calibrator should be tested in standard cup and micro cup.
2Start test.
After sample registration, click start test key to start analysis.
Note : Instrument began to test according to calibration QC sample sequence. If there are ISE items, test
according to ISE colorimetric sequence.
6.2.9 Testing
1System monitor
During sample testing, the status of sample disk, analysis disk and reagent disk can be real time monitored.
(a) Enter menu, click key, select reagent disk in , and

then click the reagent position in reagent disk chart, all the relevant information will come forth, as figure
6-22shows:
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Figure 6-22
Reagent remaining volume: Single-click the corresponding position of reagent in the reagent disk chart,
the reagent remaining volume will be showed directly by chart and percent mode in menu.
Remaining volume test: In terms of the remaining volume and the set volume in chemistry parameter,
instrument will automatically calculate the remaining test quantity.
Remaining volume: Display the reagent remaining volume in the current position in ml unit.
Reagent status: Different color indicates different reagent status.
Reagent normal: Test volume conforms to the test requirement. Show as green color.
Reagent shortage: Reagent volume or reagent remaining test times is less than setup value in System
setup form. This is called reagent shortage. Show as violet color.
Reagent absence: Reagent volume is 0 ml. Show as red color.
Reagent not in use: Reagents has registered but it is not used for test. Show as white color.
(b) Enter the menu, single-click key, and then click the relevant position in
reaction disk chart. All information of reaction cuvette will be displayed as figure 6-23 show:
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Figure 6-23
Test status: Display the current reaction cuvette status. In the monitor chart, different color indicates
different status.
Vacancy : The reaction cuvette is not used for current test. Show as white color.
Sampling: The reaction cuvette is sampling. Show as yellow color.
Reagent 1, 4 : Reagent in the reaction cuvette is infused with reagent 1(R1) and reagent 4 ( R4) . Show
as blue color.
Reagent 2, 3 : Reagent in the reaction cuvette is infused with reagent 2(R2) and reagent 3 ( R3) . Show
as pink color.
Completion : Result has been calculated from the tested sample of the reaction cuvette. Show as green
color.
Dirty cuvette: The cell blank value has exceeded the normal range. Show as red color.
Sample No.: The No. of sample that is tested in the reaction cuvette.
Item name: The name of analyzed item, which is tested in the reaction cuvette.
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(c) Enter the menu, click key, select the disk No. from sample disk menu
and the sample No. from sample No. menu, or click the monitor chart of sample disk by mouse, the relevant
information will be displayed as figure 6-24 shows:
Figure 6-24
Test status: Display the current sample status. In sample disk chart, different color indicates different
status.
Vacancy: Sample in this position doesnt register. Show as white color.
Waiting for test: Sample in this position is registered, but not sampling. Show as green color.
Sampling: Sample probe is assimilating in this position and adding them to reaction cuvette. Show as
yellow color.
Analysis: Sampling Complete, and sample is being analyzed. Waiting for the result. Show as pink color.
Completion: Get the sample result.
(2) Sampling stop or sampling continue
Sampling stop can be execute only when testing, click the continue key to continue sampling.
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If disk number changes, instrument sampling may temporarily stop, click continue key to go on sampling.
(3) Emergence stop
Click key when testing, instrument may stop the current action. Emergence stop is not allowed
when scanning sample barcode.
(4) Sample addition
When testing, other sample could be edited in Sample registry form. Click key to send
sample add order.
6.2.10 Test result checkup (Result data)
! Warning:
Sample with lipemia, homolysis and icterus could affect the test result.
Make sure that sample is not cloudy and with no clot, or sample probe could be jammed and effect test
result.
Substance in sample, such as medicine, anticoagulant , preservative , may disturb test result.
Avoid long time contact with air, or sample will volatilize, thus affects test result.
Incorrect parameter setup could effects test result.
System maintenance that not conform to user manual could cause contamination and instrument damage,
thus effects test result.
Revise or add test result is not recommended by our company. And we are not responsible for this
operation.
Click key. Operator could check, delete, modify, audit, report preview, report printout, manual
recheck, history review of test result.
(1) Daily result
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For checking daily result, select the same day results in . All daily sample
information can be displayed in the result data menu as figure 6-25 shows.
Figure 6-25
Sample information is at the left side of menu. Sample test result is at the right side of menu.
(a) Reaction curve.
In order to check sample reaction curve, click key, select the desired sample number and test
item, Select the wavelength type, that is dominant wavelength and secondary wavelength. The absorbency of
each light point is connected by line. As figure 6-26:
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Figure 6-26
In order to check the absorbency value of test light point, select the desired point in pull down menu. The
absorbency value can be displayed.
(b) Review
In order to audit single sample, single-click the record key. In order to check batch sample,
single-click key, input the start and end sample number in sample number range functional
block, and then click key. As figure 6-27 show:
Figure 6-27
Single-click close key to exit.
Note 1: The start sample No. should be less than or equal to the end sample No..
Note 2: Sample without result or name is not allowed to audit.
Note 3: Just administrator privileges can modify and delete the audited sample.
Note 4: The administrator can modify the current and the previous test results, the operator can only modify
the test results of the day.
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(c) Report preview and print
Single-click to preview the record to be printed, as figure 6-28shows. Click cancel key to
exit.
Figure 6-28
In order to print single sample report, choose the record, then click key.
In order to print batch sample report, single-click key. Input the start and end sample No. in
sample No. range functional block, and then click key . For example, print sample result from
1 to 14, as figure 6-29 show:
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Figure 6-29
Single-click print the audited report, this procedure only apply for checked sample report, not for the
unchecked report. If dont choose this function, all report will be printed out.
Single-click key to exit.
Note: When printing batch report, the number of start sample must be less than the number of end sample.
(d) Modify and delete the result
Double- click the sample record to be modified, enter the menu. Input the new result in the check result
functional block, and then click save key. As figure 6-30 shows.
Figure 6-30
Click close key to exit the current menu.
Note: Addition of result and modification are not allowed if no result happens to some samples.
Single- click the sample record to be deleted. Then click key , as figure 6-31 shows.
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Figure 6-31
Enter the start and end of samples No. samples, and then select the analysis item, click the "Delete" key to
delete records.
(e) Addition result
All samples except those are being tested result can be added with both analytical item and manual item.
Click Superadd Resultkey in test result to enter addition result form, select , as
figure6-32 shows.
Figure 6-32
Addition of analytical items: this method is applicable to the sample registered already.
(a) Select analytical item sample No. in sample No. pull-down functional block.
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(b) Select short form of analytical item sample No. in analytical item pull-down functional block.
(c) Click Superadd key.
(d) Click start analysis key to carry out the addition test.
Add manual item: this method is applicable to the items not tested in the instrument but needed to add result in
test result.
Click key in addition result form to start manual item addition, as figure 6-33 shows.
Figure 6-33
(a) Select additional manual item sample No. in sample pull-down functional block.
(b) Select additional manual item short form in item info. functional block.
(c) Click Superadd key.
Note: Manual results can be added to the test results only after the item information has been registered in the
"Manual item settings" of previous window "System Settings".
(2) Check results within three days
Single-click radio button.
(3) Query all the result
Single-click key to check all data. As figure 6-34 shows:
126
Figure 6-34
(a) Query by date
Select the inquiry record as the start date: to the end date .
Single-click key, the qualified record will be displayed in the functional block. In order to
check one day record, input the same date in block.
(b) Query by patient name
Input the patients whole name or last name in functional block, click
key. The qualified record will be displayed in the functional block.
(c) Query by sample number
Input the sample number in functional block, click key. The

qualified record will be displayed in the functional block.
(d) Query by case number
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Input the case number in functional block, click key. The

(e) Query by bed number
Input bed number in functional block, then click key. The

(f) Query by barcode
Input the sample barcode in functional block click key. The

(g) Query by delivery dept.
Select the delivery dept. in the pull-down menu of , click key.

The qualified record will be displayed in the functional block. Contents of the pull-down menu is from
hospital info. from.
(h) Query by delivery doctor
Select the delivery doctor in the pull-down menu of , input either the doctors whole
name or the last name , then click functional key, The qualified record will be displayed in
the functional block. Contents of the pull-down menu is from hospital Info. form.
Click key to exit, and then continue other operation.
(i) Print list: Click the key, and a list of test results will be printed for archiving.
(j) Modify the results: Click key after select the required test item to have test results
modified (input the revised results in the box behind test result).
(4) Query item reuslt
Click " " in the interface shown as figure 6-25 to enter into test item search query window as
figure 6-35 shows:
128
Figure 6-35
(a) Enter the start date and finish date required in the box behind the test date.
(b) Enter the start and end number required in the box behind sample code.
(c) Enter the item name required behind the item name, and the projects complying with all conditions will be
displayed on the right side column.
(d) Click on the " " to the item coefficient of variation as following shows:
Figure 6-36
The maximum, minimum, extreme difference, mean, standard deviation and coefficient of variation view can
be available, which can conveniently confirm the repeatability of the instrument.
Note: When the alarm of sample probe abnormality as in 5-13 occurs, the test result will be marked with red
color which means the result can be unreliable due to abnornmal assimilation of sample, a yellow color which
means the result can be a reference for the tested volume is less than the set volume. Yellow will be used to
mark if there is neither sample nor reagent.
6.2.11 Sample recheck

There are two register methods: automatically registration and manual registration. Sample number is not
change when recheck. Reset the sample volume in chemistry parameter form.
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(1) Automatic registration.
After sample test finished, instrument will automatically add sample info into reset form. The reset information
is defaulted set the same as first test. Operator can alter the data. Relationship between sample type and
sample volume is as table 6-6 shows:
Conditions for automatic registration Sample type

The lower limit of technical limit over Increment
The upper limit of technical limit over Decrement
The limit of reaction absorbency over Decrement
Prozone check value over Decrement
The limit of reaction solution absorbency over 3.3ABS Decrement
Table 6-6
Single-click key, instrument will carry out recheck test.
(2) Manual registration
After the initial test, if samples need to recheck, click the " " key in the "Results" window, such as
" ", the item information will be added to the recheck
list. Click on the " " key, as shown in figure 6-37:
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Figure 6-37
Recheck sample should be confirmed in the "Recheck item settings" window, click as
figure 6-38, input sample No. and choose the rerun item, click to register the sample for
rerunning.
131
Figure 6-38
Click " " button, select the reasons needed of recheck as shown in figure 6-39:
132
Figure 6-39
After settings, click on the " " key to automatically return to "Recheck item settings" window,
click " " to test. This window is the model window so that other operation can be available after
click "Close" button.
Note 1: Only the test results of the day can be rechecked.
Note 2: Sending recheck instruct by single-clicking Start Recheck to execute recheck.test.
6.2.12 Analyze complete
1Recheck test result
After rerunning, right-click the results of the sample in menu, as Figure 6-40 shows:
133
Figure 6-40
Click " " to replace the rerun results, as shown as Figure 6-41, and then confirm,
review and print the test results.
134
Figure 6-41
Click " " to replace all the rerun results.
Note: The test results also can be covered with rerunning results by audit.
2Database backup
Backup database In menu to avoid data lost.
3System sleep
Sleep indicates that instrument is at half-stop status, only cooling system keeps working. Instrument will
automatically start up in specified time.
Set up the time to awaken the instrument in system setup menu. Click sleep key. Instrument will shut off
all power supply besides cooling system. Status bar remind of instrument sleep. Sleep mode can be set only
in the stand-by state.
If awakened time is not coming, click awaken key to relieve sleep mode, instrument will carry out the same
135
operations as power on.
4Turn off instrument
Exit the software program of SAPPHIRE 800, turn off the power supply according to the following sequence:
printer power supply, host computer power supply, display power supply, analysis system of control power
supply, general power supply (general power cannot be cut when reagents are in cooling unit).
5Preparation for next measuring
Check if the reagent lid is closed well or not. Take away the sample cup or test tube with Calibrator, Controls,
diluent and sample. Drain the waste solution. in waste barrel. Check if reagent probe, sample probe and
stirring rod are contaminated or bended. Check if the surface of analyze unit /operation unit is dirty.
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Chapter 7 Calibration Information
Single-click the key to carry out the registration of calibration information and the check of
calibration result.
7.1 Colorimetric calibration
7.1.1 Calibration registration for colorimetric items
Single-click key in calibration information menu, then click the
key, as the figure 7-1 shows:
Figure 7-1
(a) Select the proper calibration type in calibration type menu. Calibration type is as table 7-1 shows:
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Calibration Standard Calibration

Calibration method Application example
Type solution volume result
K coefficient method,
Blank renew reagent All points calibration
Blank solution when standard solution
calibration blank value method
test is omitted.
Two points linear and
multi-points linear
Span One point except Recheck standard solution
Renew k value Calibration
calibration blank solution. point 1
Logit- Log3P
Logit- Log4P
Linear two points and Linear 2 points method
Renew reagent multi-points linear finish standard curve.
2 points Blank solution
blank value and calibration Multi-point method,omitted
calibration and span points
K value Logit- Log3P the quantity of calibration
Logit- Log4P solution.
Linear multi-point
Calibration
Renew standard
Full points All registered isozyme Q Multipoint standard curve
curve by all
calibration calibrator isozyme P isozyme method
points
nonlinear working
curve calibration
Table 7-1
For detailed information please refer to chapter 2.2.2, 2.2.3
(b) Select desired calibration item
Select the item name to be calibrated in registered calibration item form. As figure 7-2 shows:
138
Figure 7-2
(c) Single-click register calibration item key, the selected items will automatically be displayed in
registration list. New registration item will carry out calibration. If not, even select the calibration test
function, instrument will not carry out calibration. The concentration and position of Calibrator can be showed
in the form.
(d) In order to delete calibration item , select it and then click delete key.
(e) After registration of the calibration information, click the "calibration test" to calibration test.
7.1.2 Calibration result of colorimetric item

(1) Calibration result
Single-click key, check calibration result, such as: Reagent blank , K factor, approximate
function of constant A.B.C from multi-points calibration curve etc. As figure 7-3 shows:
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Figure 7-3
In order to modify the calibration result, delete the old result, input the new one, and then single-click
key.
(2) Calibration curve
(a) Single-click key in calibration result menu. and then select the desired item name to
be checked. The item of calibration type, S1ABS, K, A, B, C will be displayed in the form.
(b) The reaction curve of the calibration item is showed as figure 7-4. The abscissa represents the
concentration, the ordinate represents the absorbency. Absorbency range can be changed by revise
. Click key to exit.
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Figure 7-4
(c) If view the calibration absorbance values, in the "STD" drop-down list box to choose to view the
calibration solution (calibration solution 1 ~ 6), the calibration of the two absorbance values will be displayed .
3Calibration tracing
Instrument will automatically store the absorbency of Calibrator. The tracing graph can check the stability of
absorbency variety, therefore the calibration accuracy can be checked.
(a) Single-click key, select the item name, the number of Calibrator. then click
key. The 50 times absorbency value will be displayed in the graph. The abscissa represents
the calibration times, the ordinate represents the absorbency value. Absorbency range can be altered by revise
. as figure 7-5 show.
(b) In order to print the calibration trace graph, single-click key.
(c) Single-click key to exit.
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Figure 7-5
4Reaction process
Check the absorbency variety of each item in different time point through reaction monitor form. Check the
reaction status and check if the test value of absorbency is stable or not through reaction curve graph.
(a) Single-click key in calibration menu, select the item name and the Calibrator number.
Because of each Calibrator is tested twice, select the test times, main wavelength, sub wavelength etc., then the
reaction curve graph of Calibrator will be displayed. The abscissa represents the photometric point, the
ordinate represent the absorbency as figure 7-6 shows:
142
Figure 7-7
(b) In order to check the detailed absorbency value of one photometric point, select the desired point in
photometric point pull-down list. The absorbency value will be displayed.
(c) Change the absorbency range by revising . Single-click key to print
out reaction curve, single-click key to exit.
Main wavelength: display the reaction curve of main wavelength.
Sub wavelength: display the reaction curve of sub wavelength
Main wavelength- Sub wavelength: display reaction curve of main wavelength subtracting sub
wavelength.
Note: after adding new item, calibration of the new should be implemented first, and in correct calibration
result may affect accuracy of result.
(5) print result
Click print result to preview the result of colorimetric item calibration. In order to print the result, click
print key upper side of screen.
7.2 ISE calibration
Single-click key in menu to check the registration and result of ISE

calibration items, as figure 7-7 shows:
143
Figure 7-7
(1) Calibration registration
If carry out the calibration for ISE items, sign in front of the item.
(2) Calibration result
Instrument will automatically display the calibration result when carries out ISE test calibration. Alarm is
issued when abnormality exists.
In ISE calibration, Calibrator has been measured for three times. In calculation, the mean value of the second
and the third times result is used.
Check the slope value, the concentration of internal standard liquid, compensation value in Calibration
result . After finishing ISE calibration, instrument will automatically calculate the compensation value. If the
compensation value is the difference between the input value and the test value of Calibrator 3. In order to
revise the compensation value, delete the origin value, and input the number, then click key.
(3) Print result
Click print result to preview the result of ISE item calibration. In order to print the result, click print key
upper side of screen.
144
Chapter 8 Quality Control

The goal of quality control in lab is to guarantee test result reliability for each sample. The reliability include two
aspects, one is precision: the test result is in good repetition, daily test result changes little, the main purpose is to
eliminate or reduce the influence caused by random error, the other one is high accuracy: that the test result is
correct, close to the truth, and eliminate or reduce the influence caused by system error.
Random error: The difference between test result and the mean value of the same target tested many times in
a repetitious conditions is called random error.
System error: The difference between true value and the mean value of the same target tested many times in a
repetitious conditions is called system error.
Accuracy: The integration of system error and random error in the test result, indicate the consistent degree
between test result and true value.
Precision: The consistent degree among many test result of one target in a specified conditions, indicate the
degree of random error magnitude among the test results.
L-J ( levey Jennings) QC chart: QC chart is a kind of graph with quality control limit. QC limit is
controllable analysis method to known specimen (QC sample) carry out repetitious test to get the mean value
( X ) and standard deviation (SD). X 2 SD is warning limit. X 3SD is out of control limit.
8.1 QC registration
Single-click the key, then click the key. At most eight QC samples can be used
simultaneously to carry out quality control. As figure 8-1 shows.
145
Figure 8-1
8.1.1 QC regulation setup
(a) Click key, the Westgard QC regulation is showed in figure 8-2:
146
Figure 8-2
Operator could select the needed QC regulation, click to save the setup. After setup, the
QC interval and Monthly QC may process QC analyze according to the regulation.
According to Westgard multi-rule judgment base, carry out the incontrollable analysis to the test result, as
figure 8-2 shows:
QC Data
NO
Under control
1
YES NO
NO NO NO NO
10 X
1 2 R 4
YES YES YES YES YES
Out of control
Figure 8-3
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Judgment benchmark instruction:
1 2S: One QC result exceeds mean value 2 SD, which is judged as warning regulation, and initializes other
regulation to check QC data.
1 3S: One QC result exceeds mean value 3 SD, which is judged as lose control, this regulation is sensitive
to random error.
2 2S: Two consecutive QC result simultaneously exceed mean value +2 SD or -2 SD, which is judged as lose
control, this regulation is sensitive to system error.
R 4S: One control result exceeds mean value +2 SD, another exceeds -2 SD, which is judged as lose control,
and this regulation is sensitive to random error.
4 1S: Four consecutive QC results exceed simultaneously mean value +1 SD or -1 SD, which is judged as
lose control , this regulation is sensitive to system error.
10 : Ten consecutive QC results all are in the same side of mean value (higher or lower than mean value, no
X
requirement to the degree of deflection), which is judged as lose control, this regulation is sensitive to
system error.
8.1.2 QC name setup
Click button, and click , as figure 8-4 shows:
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Figure 8-4
Input Controls name in QC name, and then click key.
In order to delete, select the QC name in pull down menu, and click key, click
key to exit.
8.1.3 QC item registration

(a) Select the position of QC sample from C1-C8 in the position pull down menu.
(b) Select the item name in the QC name pull-down menu.
(c) Input lots No. of Controls in the QC lot number functional field.
(d) Select type of Controls, such as blood, urine, in sample type pull down menu.
(e) Input target value and standard deviation.
(f) Click add key when above parameters are correctly inputted. All inputted parameter is saved in the left
work area.
Note: After register the QC item, make sure check which item may carry out QC test, click execute key in
front of QC item.
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In order to carry out QC test according to QC interval, input QC interval in chemistry parameter. In order to
carry out one time QC test before sample test, click key, and then click .
8.1.4 QC parameter modification

If registered parameter need modify, single-click the desired items in the left side of filed, the color will
change. Saved QC parameter will display in the right side of field. Directly input the parameter on the item,
then click key to finish this procedure.
8.1.5 Delete QC item

Single-click the item to be deleted in the left side of field to eliminate the registered color changes after being
clicked. Click key to finish this operation. All information of this item will be deleted.
Note: At the same time does not permit to test the same item of different QC name on a location.
8.2 QC interval
The QC interval is set in the chemistry parameter menu, and instrument will automatically carry out QC test
according to the set interval sample number. After analysis finish, check the QC result in the
menu, and a QC result chart is showed as well. In the chart, the abscissa represent test times, the ordinate
represent concentration.
(a) Select QC item and lot No. in the pull-down menu, QC result will be displayed in the QC
chart, as figure 8-5 shows:
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Figure 8-5
(b) Single-click key to analyze QC data according to Westgard Multi-rule Judgment base.
(c) Single-click to check and modify the QC result, in order to revise the result , input the
new data , click result revise key as figure 8-6 shows
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Figure 8-6
In order to add QC result, single-click Add key after input desired QC item result in the Result functional
block.
In order to modify QC result, single- click the desired QC result in the left side working area, input
modification result into the Result functional block.
In order to delete QC result, single-click the desired QC result in the left side of working area, the click
Delete key.
Single-click Close to exit QC result.
(d) Single-click key to check the whole reaction process of QC test.
(e) Single-click key to print out the QC chart.
After QC test finish, instrument will automatically calculated real test QC target value (mean value), standard
deviation, coefficient of variation, range (alteration range) etc. data.
- Xi
i =1
Target value X :
N
( Xi MV )
2
i =1
Standard deviationSD :
N 1
SD
Coefficient VariationCV% : 100%
mv
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Range: X max Xmin

N: test times, Xi : test result.
8.3 Monthly quality control
After finish analysis, check the QC result in the form. This abscissa of QC chart represent test
date, ordinate indicate concentration.
(a) Select QC item and lot No. and month in the pull-down menu, QC result will be displayed in
the QC chart as figure 8-7 shows:
Figure 8-7
(b) Single-click key to analyze QC data according to Westgard Multi-rule Judgment base.
(c) Single-click to check and modify the QC result, in order to revise the result , input the
new data , and click result modify key.
(d) Single-click key to check the whole reaction process of QC test.
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(e) Single-click key to print out the QC chart.
After Qc test finish, instrument will automatically calculated real test QC target value (mean value), standard
deviation, coefficient of variation, range (alteration range) etc, data.
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Chapter 9 System Setup

System setup menu includes: chemistry parameter, profile item, calculated item, cross contamination, report
format, ISE setup, other setup,manual item, host communtication, reagent setup (If the reagent set is open, then
there is no reagent setup interface in the system setup). As the figure 9-1 shows:
Figure 9-1
Click key to exit system setup menu.
9.1 Chemistry parameter
Click functional key in main functional field . Chemistry parameter has

three sub-menu: analyze parameter, calibration parameter, range parameter.
Note: After the parameter of each menu is edited, operator should click to save the data.
9.1.1 Add/delete item

Before edit chemistry parameter, add chemistry item first.
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Click key at the lower right side of form, add or delete the test items as figure 9-2 shows:
Figure 9-2 Add and delete items
After enter add item menu, input the item number item name, and click add key to finish this
operation.
In order to delete item, move the scroll bar at the right side of list box to look for desired item, click it by
mouse, the color of chosen item will change, appear in front of chosen item, click delete key, The item
will be deleted.
Carry out other operation after click close key.
9.1.2 Analysis parameter
Click key in menu. Operator can edit or revise the analysis parameter
of colorimetric items. As figure 9-3 shows:
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Figure 9-3
Item name: Select the items abbreviation from the pull-down menu. All items may display automatically in
the list box.
Decimal digits: Operator can select the decimal digits of test result and printout result in the pull-down list
box.
Items full name: Input the full name of testing item, such as ALT, whose full name is Alanine
Aminotransferase.
Quality control interval: Input the quantity of interval sample. Input the integral number of 10 times, the
least interval quantity is 10, the most is 1000.
Test method: Select one method in the pull-down menu which is conform to reagent requirement, 1 point
assay, 2 point assay, rate A assay, rate B assay, 1 point rate assay, 2 point rate assay, 3 point assay. For
detailed introduction, please refer to 2.2.1
Item unit: Choose the chemistry item in the pull-down menu, For the add and delete of item unit, please
refer to chapter 8.3
Test time: Test time can be selected from the test result pull-down menu.
Photometry point: Instrument will record one time absorbency every 18 seconds. Please input proper
photometry point according to reagent instruction. Effective photometry point should be inputted within 2
to 49 (0 represent no input). Tested absorbency value of each test light points can be searched from reaction
157
curve.
Main wavelength: There are 12 optional wavelengths in pull down menu, select them according to reagent
manual. Main wavelengths : 340 nm,380 nm,405 nm,450 nm,480 nm,505 nm,546 nm,570 nm,600 nm,660
nm,700 nm and 750nm.
Sub wavelength: When adopting double wavelength assay to test or analyze sample, select the wavelength
from 12 wavelength in pull down menu. Secondary wavelength include: 340 nm,380 nm,405 nm,450
nm,480 nm,505 nm,546 nm,570 nm,600 nm,660 nm,700 nm and 750nm . The difference of the absorbance
value between main wavelength and secondary wavelength is used for calculated result. when select single
wavelength test, select 0 of secondary wavelength.
Instrument factor (Y=a X + b): Carry out relation calibration. The test result will be higher or lower than
expected result or result from other instrument. In order to make result in accordance with expected result
or result from other analyzer, add the calibration relation in result calculation.
Relation equation:
Y=a X + b
Y : Result after calibration
X : Real result from analyzer
a : Slope value (multiplication calibration factor)
b : Intercept value (compensation calibration factor)
When test result of the analyzer is the same as expected value, or when results of any two analyzer is
accordant, let a=1, b=o.
When results from two analyzers are different, analyzer can get an accordant result by calibration of slope
value and intercept value. Slope value is a positive number, which is less than 8 digits. Intercept value is a
real number, which is less than 8 digit.
sample volume work area: Sample volume includes normal volume, increased value and decreased
value. Left side of sample volume work area is for serum sample, right side is an optional area. Operator
can select sample type from pull down menu, as figure 9-5 shows:
Figure 9-4 sample volume
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Normal volume
In normal volume work area operator can specify sample normal volume. This work area are divided
three functional key field: sample volume, diluted sample volume, diluent volume.
[ Normal/ sample volume] : The sample volume (2ul to 35ul) is absorbed from sample container( sample
cup or tube) . If predilute is not required, the total volume of sample and reagent should be greater than or
equal to 150ul, smaller than or equal to 450ul. If diluent is required, the total volume of sample and
detergent should be greater than or equal to 105ul, the total volume of diluted sample and reagent should
be greater than 150ul, less than or equal to 450ul.
[ Normal/ diluted sample volume ] : If predilute is required, the parameter is used to set up diluted
sample volume which sucked from dilute cup and infuse to reaction cuvette that is used for analyze
reagent. The input value is within 2ul to 35ul. Input 0 to avoid predilute.
[Normal/diluent volume]: If predilute is required, the parameter is used for set up diluent volume for
dilute sample. The input value is within 2ul to 350ul. Input 0 to avoid predilute.
Decreased volume ( sample volume decrease)
Decreased volume work area is used for specify sample volume when sample concentration exceed the
upper limit of reagent linearity range. (lower than normal volume). This area is divided into 3 functional
key field: sample volume, diluted sample volume, diluent volume. After test, instrument will automatically
change decreased test result into normal volume and display on result information.
[Decrease/ sample volume]: Select a sample volume (from 2ul to 35ul, and less than normal volume),
which is sucked from sample container (sample cup or tube). If predilute is not required, the total volume
of sample and detergent should be greater than or equal to 150ul, smaller than or equal to 450ul. If dilute
is required, the total volume of sample and detergent should be greater than or equal to 150ul, the total
volume of diluted sample and reagent should be larger than 150ul, less than or equal to 450ul.
[Decrease/diluted sample volume] : If predilute is required, the parameter is used for set up diluted
sample volume which is sucked from dilute cup and infuse to reaction cuvette that is used for analyze
reagent. The input value is within 2ul to 35ul, Input 0 to avoid predilute.
[ Decrease/diluent volume] : If predilute is required, the parameter is used for set up diluent volume for
dilute sample . The input value is within 2ul to 350ul, Input 0 to avoid predilute.
Increased volume( sample volume increase)
Increased volume work area is used to specify sample volume when sample concentration exceed the
lower limit of reagent linearity range. (more than normal volume). This area is divided into 3 functional
key field: sample volume, diluted sample volume, diluent volume.
[Increase/ sample volume] : Select the sample volume (2ul to 35ul,more than normal volume) ,which is
sucked from sample container ( sample cup or tube). If predilute is not required, the total volume of
sample and reagent should be greater than or equal to 150ul, smaller than or equal to 450ul. If predilute is
required, the total volume of sample and detergent should be larger than or equal to 105ul, the total
volume of diluted sample and reagent should be larger than 150 ul, smaller than or equal than 450ul. Input
0 to avoid predilute
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[Increase/diluted sample volume] : If predilute is required, the parameter is used for set up diluted
sample volume which sucked from dilute cup and infuse to reaction cuvette that is used for analyze, The
input value is within 2ul to 35ul. Input 0 to avoid predilute.
[Increase/diluent volume] : If predilute is required, the parameter is used to set up diluent volume for
dilute sample . The input value is within 2ul to 350ul, Input 0 to avoid predilute.
Reagent work area: Contents of reagent include reagent volume and reagent position. Reagent 1(R1) ,
reagent 2 (R2), reagent 3 (R3), reagent 4 (R4) are reagent type . R1 and R4 are in reagent disk 1, R1 probe
absorb reagent. R2 and R3 are in reagent disk 2, R2 probe absorb reagent. As figure 9-5 shows:
Figure 9-5
Reagent volume: Reagent unit: ul. Reagent probe can exactly suck 20ul to 350ul solution. 0 represent
no reagent is added.
Position: Display reagent position in reagent disk. Register this parameter in reagent info.
Second half item of two test analyze: In order to carry out two test analyze, select the name of second half
item in second half item of two test analyze pull down menu.
Prozone check: input the range value of prozone check, setup the upper limit and lower limit.
Absorbance limit: Input the range value of absorbance, setup the positive reaction and negative reaction.
9.1.3 Calibration parameter
Click button in form, as figure 9-6 shows:
160
Figure 9-6
(1) Select item name in select test pull-down menu.
(2) In terms of reagent instruction, Check calibration type, calibration point, span point, and weight
coefficient etc. parameter.
(3) Input the concentration and position of Calibrator.
(4) Input the parameter of calibration check. For detailed operation, please refer to chapter 2.3.1
(5) For automatic calibration, input the overtime of automatic calibration according to relevant calibration
type. If automatic calibration time comes when stand-by, instrument will automatically carry out
calibration before test next time. In same item, if automatic calibration conflict with manual calibration,
carry out manual calibration only. Click 0 in time position if automatic calibration to avoid automatic
calibration.
(6) After check the parameter, click save key to save.
Calibration point: Input the quantity of Calibrator in functional field. (among 1-6).
Span point: Input the relevant span point in functional field. (among 2-6).
9.1.4 Range parameter
Click key in the form to setup the reference value range and
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linearity range. Click save button to save the parameter.
Figure 9-7
Special reference range: If patient age, and patient gender are different, the reference value range are
different too. Click key. For example, the special reference range of UA:
0.1~0.34 for male aged 0~15, female 0.12~0.33 aged the same. 0.21~0.43 for male aged 14~50, 0.15~0.36
for female aged the same. 0.28~0.50 for male aged more than 50, 0.21~0.43 for female aged the same. As
figure 9-8 shows:
162
Figure 9-8
Note: If you choose this, the operator must calculate the results of equipment prior to patient age and sex of the
set, otherwise the test results will not be the scope of information and tips.
Default reference range: select default reference value range when the reference value
range are the same despite the difference patient age and gender.
For example, the default reference value range of urine amylase is 0~640U/L , as figure 9-9 shows.
Figure 9-9
Linearity range: Input the upper limit and lower limit of reagent linearity in functional field. Alarm is issued
when test result exceed the range.
Note: The chemistry parameter in the manual is taken as an example, not real test parameter. Operator should set
parameter according to reagent manual .
9.2 Item combination
Click key system setup form, set up item combination, as figure 9-10 shows:
163
Figure 9-10
(1) Input the number of combination item in number functional field, the number cant be repeated, or it
cannot be saved.
(2) Input the name of item combination in item combination name functional field, Character and number are
all allowed, but cant be repeated. Or it cannot be saved.
(3) Select item of item combination, click check box in front of item name, indicate that is selected. Click
check box again, and indicate that it is cancel.
(4) Click key, Combination item number, name will be displayed in the right side of
functional field. Click the number or name, all items will be automatically showed in functional field.
(5) Select the number or name of desired combination item, click key to delete the
combination item.
9.3 Calculated item
Test Calculation is on the base of two or more item test results, use special calculation method to get a new item,
such as A/G..
164
Click key in form. As figure 9-11 shows:
Figure 9-11
(1) Input test name in test item Functional field.
(2) Input item name in test full name functional field.
(3) Select the unit of new calculated item in unit pull down menu. Select the decimal digits of new
calculated item in decimal digits pull down menu.
(4) Select the reference value range of new calculated item in reference value range pull down menu.
(5)Edit the calculation formula the edited information will be showed in calculation formula functional field,
click add key to finish edition work.
(6) In order to delete calculation item, click the desired item, and then click delete key.
Edition method of calculation formula ( for instance: A/G )
Set up item name, unit, decimal digit, reference value range according to the above procedure, select ALB
in test name pull down menu, select/,in sign pull down menu, select TP in item name pull
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down menu, select - in sign pull down menu. The edit of formula can be showed in calculation
formula. If there are some number in formula, select any number among 0,1,2,3,4,5,6,7,8,9 in number pull
down menu. After input finish, click key, the formula will be showed at the right side of
functional field.
Figure 9-12
Click key beside the calculation formula functional field to delete the wrong content.
9.4 Cross contamination
Cross contamination obviation is a function to avoid cross contamination among analyzing items. The degree
of cross contamination is different due to different reagent ingredient. For avoiding cross contamination among
reagents, we strongly suggest separate the items with cross contamination and the items without cross
contamination. If all item cannot be separated, automatic washing function can be added before tested item in
order decrease the cross contamination in maximum extent. But the cross contamination function may decrease
the test velocity.
Cross contamination include: reagent probe, reaction cuvette, sample probe. Detergent is located at position 45
in reagent disk 1 and reagent disk 2.
Click key in menu.
9.4.1 Reagent probe cross contamination
Click key in menu to setup avoid cross contamination of reagent

probe. As figure 9-13 shows:
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Figure 9-13 Reagent probe cross contamination
(1) Select reagent probe R1 or R2 in reagent work field. indicate R1 has been selected.
Input the detergent volume (ul).
(2) Select the reagent type in item pull down menu in from reagent work area.
(3) Select reagent type in item pull down menu in to reagent work area
(4) Click key, the set information will be displayed in left side functional field.
(5) Click key, relevant information will be deleted.
9.4.2 Reaction cuvette cross contamination
Click key to set avoiding cross contamination. As figure 9-14 shows:
167
Figure 9-14
(1) Select item that needs to be set in item name pull down menu.
(2) Input R1 detergent volume (ul) in R1 detergent Volume work area.
(3) Input R2 detergent volume (ul) in R2 detergent volume work area.
(4) Click key, the set information will be displayed in left side of functional field.
(5) Click key, information will be deleted. And click close key to exit the current menu.
9.4.3 Sample probe cross contamination
Click key to set sample cross contamination obviation, as figure 9-15 shows:
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Figure 9-15
(1) Select the items to be set in item name pull -down menu.
(2) Select detergent position from W1,W2,W3.
(3) Click add key, the set information will be displayed in the left side of functional field.
(4) Click delete key , information will be deleted. Click close key to exit the current menu.
9.5 Report sheet format
Click key to set printout info. and format. As figure 9-16 shows:
169
Figure 9-16
9.5.1 Basic information setup

(1) Input the first name and second name of the organization in basic report information work area. If there
is no second name, do not input it.
(2) If endnotes of report is used, please sign in report endnotes functional field. Input the first and
second line of report content. Endnotes may not be inputted if no need.
(3) Please sign in automatic add calculated item functional field to add the item name into print list.
(4) Click key to save basic information of report.
9.5.2 Print sequence setup

Input the print sequence of report item in print order work area. Print them in the sequence of 0,1,2,3,from
small to large. If select 0, instrument will print according to the item number. Click to save
the setup parameter.
9.5.3 Report printout format setup
Click key to set report template and print option.
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9.5.3.1 Report template setup
(a) Click to select report template in pull down menu, preview the printout report
template at the right side of form, adjust the preview scale in functional field. As figure
9-17 shows.
Figure 9-17
(b) Click key to edit template in template menu.
(c) Select one template and click key to delete template..
(d) Click key to input new template name, As figure 9-18 show.
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Figure 9-18
(e) Click key to exit report template setup menu.
9.5.3.2 Print option setup
(a) Click key to set printout report option. As figure 9-19 show.
Figure 9-19
(b) Select the contents of report and sign in functional field. Select print all item, and all reminding, item
code, check result, item name, unit , reference value will be printed.
(c) Select and click to save select information.
(d) Click key to exit print option setup menu.
9.5.3.3 default format setup
Click key in report format work area. And select a report format.
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9.6 ISE Setup
Single-click key in system setup menu to setup ISE parameter. As figure 9-20 shows.
Figure 9-20
(1) Select the items name and sample type, decimal digits, item unit, QC interval, etc.
(2) Input the concentration of Calibrator in calibration parameter work area and select the relevant
calibration position. Calibrator 1 is ISE low concentration Calibrator. Calibrator 2 is ISE high concentration
Calibrator. Calibrator 3 is compensation liquid.
(3) Input the remaining volume of Reference Liquid, Internal Standard Liquid and Diluent in reagent
remaining volume work area in ml, click save key. Instrument will automatically subtract the wastage and
display the remaining volume in work area.
(4) Set reference value range in parameter setup work area.
(5) Single-click key to save the set data.
(6) Single-click key to exit the menu.
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9.7 Other setup
Single-click key to set the sample barcode, reagent barcode, sample alarm, reagent alarm, ISE,
time wakening etc. function. Single-click key to save the parameter. Click
key to exit. As figure 9-21 shows:
Figure 9-21
(a) Barcode setup
Check barcode device, if barcode device is connected well, and use would like to execute barcode device
checkup of sample disk, R1 reagent disk, R2 reagent disk, select in functional block, if barcode device is
not connected, use should not select , or it alarm may occurs. Scanning barcode before sample analyze, in
order to checkup sample barcode scanning function, select in functional block.
Scan reagent open area barcode: Reagent close area must execute reagent barcode scanning, in order to scan
reagent open area barcode, select in functional block.
174
Clean reagent open area barcode info.: If want to delete Reagent name, Reagent type in the reagent open
area barcode , select in functional block.
(b) ISE setup
Execute ISE: Sign in ISE setup if any test required ISE test.
(c) Timing wakening:
If sign in functional block, the instrument will automatically be awakened in specified time. Input the
desired date in awaking date list, and the wakening time in functional block ( such as : ** hour ** minute)
(d) Reagent alarm
Reagent remaining times: input reagent remaining test times. When instrument detect the remaining test times
is less than set value, an alarm will be issued.
Reagent remaining volume: input reagent remaining volume. When instrument detect the remaining volume is
less than set value, an alarm will be issued.
(e) ISE reagent alarm
Reference Liquid remaining volume: Input the Reference Liquid volume for alarm in ml.
Internal Standard Liquid remaining volume: Input the Internal Standard Liquid volume for alarm in ml.
Diluent remaining volume: Input the Diluent volume for alarm in ml.
9.8 Manual item setup
Manual item means the test is not processed in the instrument, but to add the result by handwork in test
result block.
Single-click manual item setup key to setup the item short form, item name, item unit, reference range.
Single-click add to save parameter after setup as figure 9-22 shows.
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Figure 9-22
Single-click close to exit.
(a) Input the manual item short form in the item short form functional block.
(b) Input the manual item name in the item name functional block.
(c) Select the manual unit in the unit pull-down block.
(d) Input the manual item reference value range in the reference range functional block.
(e) In order to delete the set information, single-click the set information in work area, single-click delete
key.
9.9 Host communication setup
Host communication setup is needed in system setup interface for the online between the analyzer and other
LIS systems. Standard RS-232 serial communications is adopted, and the ASTM1394 protocol standards are
obeyed as figure 9-23 shows:
176
Figure 9-23
1. Open communication: Select this option, start communications with the LIS communication, whereas, LIS
communications fails.
2. Bidirectional: Select this option to fulfill bidirectional communications with the LIS.
3. Simplified mode: Data transmission and transmission frequency can be reduced in terms of effective
bidirectional communications.
4. Data transmission mode: Two modes, real-time mode, namely, when all the items of each sample are
completed, real-time transmission is carried out in the unit of sample, batch mode, namely, batch manual
transmission can be only conducted after the completion of the result.
5. Gather sample mode: Only used for bidirectional communications. Sample No." conducts sample
registration based on the only index number, serial number of sample. "Sample ID (Barcode)" conducts sample
registration based on the only index number, sample barcode, whereas, this mode requires selecting sample
barcode used by equipment in the "Other Setup" of system Settings.
6. Sample save mode: Only used for bidirectional communications. "First analyzer" means that the registered
sample will be taken for storage when the sample applied at the side of LIS exists at side of the instrument,
which will not be registered. "First HOST" means that the sample applied at the side of LIS exists at side of
the instrument will be taken for storage, which will replace the registered sample.
7. Analyzer ID: It is used for communications mark in the transmission with LIS.
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8. Host ID: It is the LIS system mark of communications with instrument.
9. Serial port: Serial number of communications can not use serial port 1. No default value requires user to set
up according to the actual situation.
10. Baud rate: Select the serial baud rate of communications among 4800,9600,19200.
11. Data bits: Select the data bit of communications at 7 or 8.
12. Stop bits: Select stop bit of communications at 1 or 2.
13. Parity : Select the communication parity bit among N, M, E, O, S.
14. Timeout retry time: Free time can be set for interval time.
15. Timeout retry count: Overtime and retry times can be set.
Note: The default value for equipment communications protocol are 19200, N, 8,1. Please contact distributor
for the detailed information of LIS online.
9.10 Reagent setup
Click Reagent top-up settings", as shown in figure 9-24, ISE reagent, alkaline cleaning liquid, anti-bacterial
phosphor-free cleaning liquid can be added.
Figure 9-24
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In this interface, the reagent information can be viewed. When the reagent volume is insufficient, the
instrument will issue alarm automatically after the current test and refuse to next test, and the shortage volume
of reagent requires supplement.
Enter barcode number of the corresponding supplied reagent in the barcode box, click the " " key,
and " " will be displayed in the prompt field, thereafter, test can
be continued after top-up of reagent in reagent disk.
If you enter the wrong barcode number, the column shows the prompt
" ", please check the bar code information,
and re-enter it to carry out top-up of reagent.
Chapter 10 System management
10.1 User information
The user with administrator permission can add, delete or modify the user information.
Single-click the key in main functional filed, then click key to set the operator ID,
name, password, reconfirm password ( two times inputted password should be the same) , mnemonics, etc. As
figure 10-1 shows:
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Figure 10-1
Single-click key, the relevant info. will be displayed in the form. Click
key to eliminate the user information.
Click key to exit .
Administrator: User with administrator permission can set, delete, check , browse and test all functions
Inquiry: some function windows are available to user, setup and test unavailable.
Operation: User with operator permission can set, delete, check, browse and test all functions except for
user information.
10.2 Hospital information
Single-click the key in menu, to set the delivery dept. delivery doctor, sample
type, patient type and item unit, as figure 10-2 shows :
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Figure 10-2
Single-click key to exit the current menu.
These items will be displayed automatically after setup in patient info. form corresponding pull-down block.
10.2.1 Delivery dept
Single-click the key to set department number, name and mnemonics
Dept. No.: Input the dept. No. The information will be displayed in pull-down menu of sample register
menu.
Delivery dept.: Input the name of delivery dept., the information will be displayed in the relevant pull-down
list of sample register menu.
Mnemonics: Help the user input the information quickly. For example: the mnemonics of department
numbers can be set as KSBH, then the contents of patient type option can be replaced by inputting KSBH,
click enter key, the department number will be automatically inputted.
10.2.2 Delivery doctor
Single-click key in functional field to set Doctor No. Doctor Name etc. information. As figure
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10-3 shows:
Figure 10-3
Click key, all the information will add to delivery doctor menu. Select the info. bar to be
deleted, then click delete key , the info. bar will be eliminated.
10.3 Other information
10.3.1 Sample type
Single-click key in form, then set the serial number, sample type, mnemonics
etc information . As figure 10-4 shows:
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Figure 10-4
Select the info. bar to be deleted, then click key , the info. bar will be eliminated.
10.3.2 Patient type
Single-click key in work area to set serial number, patient type, mnemonics etc. as the figure
10-5 shows:
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Figure 10-5
10.3.3 Clinic diagnosis
Single-click key in work area to set the clinic diagnosis information. As the figure 10-6
shows:
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Figure 10-6
10.3.4 Report remark
Single-click key in working area to set the report remark information, as the figure 10-7 shows:
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Figure 10-7
Input No. remark, mnemonics in functional block, click to register remark.
10.3.5 Test unit
Click key to set the test unit, as figure 10-8 shows:
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Figure 10-8
Click key, the inputted information can be showed in test unit form. Select the info. bar to
be deleted, then click key , the info. bar will be eliminated.
10.4 Workload statistics
Workload statistics function is used for checking the workload of delivery department, deliver doctor and
check doctor. According to the desired time slice select the statistic contents, click key to
complete statistic, result is showed as statistic chart, as figure 10-9 shows:
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Figure 10-9
Click print key to preview and print the statistics chart, as figure 10-10 shows:
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Figure 10-10
10.5 Database maintenance
In order to prevent data lost, database should be backup periodically.
Single-click to backup and recover the data. As the figure 10-11shows:
Note: Please implement database backup and recovery in offline status.
Figure 10-11
Database backup: Before database backup, user could select the save path, or the database will be saved to the
default software installation folder. The file name of database is the current date plus the current time, the
postfix is *.back. Periodically backup database can avoid the data lost. When the path of backup is selected,
click backup key. The form will display the status of database backup and provide backup finish hint.
Database recover: When the software cant be used, the database backup file can recover the former data.
Select the save path of backup file, then select the backup file according to the date and time, click
recover key. The form will display the information of recovered database. If the path and file of database
backup are not selected, a hint information will pop up.
Note: In order to connect LIS system, connect it after data backup before the closure of LIS system.
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10.6 System log
Click key in menu. As the figure 10-12 shows:
Figure 10-12
System log realizes these function to check system operation, including user login, operation log, maintenance
log and alarm log. Select one log type in type work area, select the start date and finish date in date work
area, click key, all the relevant log information will be listed.
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Chapter 11 System Help
Any questions arise when operate instrument, the user could click to seek help. As figure 11-1
shows:
Figure 11-1
11.1 System help application
(1) Single-click the catalogue key, check the desired menu in the list. Single-click the back key to return
to the last menu. If instruction contents are not displayed completely, pull the scroll bar to browse the
rest.
(2) Single-click the close key to finish this application.
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Chapter 12 System Maintenance
12.1 System maintenance preparation
To ensure the accuracy and precision of the SAPPHIRE 800, the user should operate strictly according to the
SAPPHIRE 800 User Manual, and a regular maintenance is also a necessity. This is the only way to make
sure a long useful life and a reliable result, which is provided by instrument.
Please prepare the following items before carry out system maintenance
12.1.1 Instrument and Tools

(1) Accessories (prepared with SAPPHIRE 800)
Cross screwdriver..(for demounting instrument cover board)
Stainless steel ware (with diameter 03mm and 0.5mm)..(for cleaning sample probe and reagents probe)
Fixing block..(for adjusting the height of the stirring rod)
Cleaning probe tool....(for cleaning probe when blocked)
(2) To be prepared by user
Clean gauze (cleaning parts )
Swab.(for cleaning sample probe and reagents probe)
Vacuum Cleaner(for cleaning cooling fan and radiator filter)
Buckets (two)(for drainage the cold water and discharge the reagent waste)
Test tube brush.(for cleaning the cleaning tank)
Graduate or breaker (3L or 5L)(for water supply to tank)
12.1.2 Pure water

For routine run, maintenance and checkup, please use purified water with conductivity 1 us/cm max. A regular
maintenance of the purified water equipment is also a necessity. Please operate according to the manual of the
purified water equipment or contact the supplier of the purified water equipment.
12.1.3 Detergent
The detergent is used for cleaning all parts of instrument. All kinds of detergents could be purchased from
Audit Diagnostics company. Other brand detergents may cause the uncleanness of cuvette, reagent probe,
sample probe, stirring rod, pipe line, and finally result a cross contamination. Our company is not responsible
for the inaccuracy, which is conducted by the other kind of detergent.
There are five kinds detergents for CS serial:
CS-anti-bacterial phosphor-free detergent: Place CS anti-bacterial phosphor-free detergent on the 45

position on reagent disk 1, reagent disk2. Put 6ml CS anti-bacterial phosphor-free detergent in incubation
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bath when exchange water. If the detergent is not added in, air bubble may attach on the cuvette, and the
bacterial may grow in the incubation bath. Owing to there is no conductance, the liquid sensor can not detect
liquid level normally. The reagent probe may automatically suck detergent on 45 position for reagent probe
cleaning. Wipe all parts of instrument or immersion cuvette with 2% CS anti-bacterial phosphate-free
detergent.
CS-alkaline detergent: The CS-alkaline detergent in the detergent bottle which located in the front of
instrument is used for cleaning cuvette. Detergent on W1 position in sample disk is used for cleaning sample
probe.
CS-acidic detergent: The CS-acidic detergent on W3 position is used for the cleaning which could avoid
sample probe cross contamination.
CS-ISE detergent: The CS-ISE detergent on W2 position is used for cleaning for sample probe, dilution bath,
ISE pipe line after ISE test.
CS-solenoid valve cleaning liquid: Clean the concentrated waste liquid pipeline.
12.2 The Application of system maintenance menu
Click button of the main function menu to start the instrument maintenance. Select
maintenance information in the list by mouse, or remove key on keyboard, click

button, start maintenance. Instrument will carry out reset operation first among all maintenance operation.
Some maintenance item allow stop in the midway, click to finish the maintenance
operation. For those not allow stop in the midway, take other operation after maintenance finish. In order to
exit the system maintenance menu, click button.
If there is an abnormity, an alarm hint will be showed on the menu.
12.2.1 Reset
Select Instrument Reset in maintenance item list work area, then click Execute. The instrument will
automatically return to the initial position. There will be an alarm hint if mistakes happen. Emergency stop is
not allowed while resetting. Take other operation when computer stand-by. Strongly suggest user execute reset
operation after emergency stop or after adjustment of reagent probe, sample probe and stirring rod.
12.2.2 Cleaning water tank

Select water tank in maintenance item list work area, and then click Execute. The instrument will
automatically cleaning the water tank immediately. Emergency stop is not allowed during operation. Take
other operation when computer stand-by. The water quality will be contaminated if bacterial grow in the
incubation bath.
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12.2.3 Light quantity checkup

Select light quantity checkup in Maintenance item list, and then click Execute. The instrument will carry
out the light quantity checkup. The previous absorbency value and current one could be showed at the
same time. (As figure 12-1 shows). Check the menu to choose printout the result or not. The absorbency value
should be 18000. Click end maintenance to complete the light quantity checkup operation.
Normally, carry out the light quantity checkup once a month. Carry out the light quantity checkup after replace
bulb, then proceed the test after the absorbency value qualified.
Figure 12-1
12.2.4 Cell blank check

Select cell blank test in Maintenance item list work area, then click Execute. The instrument will carry
out cell blank check for 120 cuvettes.
The cell blank check value will be showed on the system maintenance menu (as figure 12-2 shows). Click
print button to print out the cell blank check value. Click end maintenance key to complete the cell blank
check operation.
Normally, carry out the cell blank check once a week is suggested. Carry out cell blank check after replace the
cuvette. Then proceed the test after the cell blank check value qualified. Do not proceed sample test if the cell
blank check value is abnormal, it may influence the accuracy of the test result.
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Figure 12-2
Cuvette number tandem: display the number of 1-120 cuvettes
340-750tandem: display the cell blank value of 120 cuvettes corresponding to the different wavelength of
340, 380, 405, 450, 480, 505, 546, 570, 600, 660, 700, 750(nm).
1(No.1 cuvette) rank: display the cell blank value of 12 type different wavelength of No.1 cuvette. A <18000
cell blank value is considered as a qualified one.
2(No.2 cuvette) rank: display the difference between two cuvette: the difference cell blank value between
No.1 cuvette and No.2 cuvette, a 800 difference value is considered as a qualified one.
3-120 cuvette rank: display the difference between 3-120 cuvette.
12.2.5 Air exhaustion of syringe

Select syringe exhaust in Maintenance work area. then click Execute. The plunger of syringe move up
and down in order to exhaust the air of syringe. Emergency stop is not allowed during operation. Take other
operation when computer stand-by.
Carry out Air exhaustion function when replace syringe or replace the connection pipeline of syringe.
12.2.6 Rinsing /air exhaust detergent pipeline

Select Rinsing/air exhaustion of detergent pipeline function, click Execute. The instrument will
automatically exhaust the air in detergent pipeline. Emergency stop is not allowed during operation. Take other
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Carry out this function when detergent bottle with CS-alkaline-detergent discharged, and there is air in the
connection pipeline.
12.2.7 Rinsing reaction cuvette

Select Rinsing reaction cuvette function, click Execute, instrument will automatically Rinsing 120
cuvettes. Click end maintenance key to end this operation.
Rinsing cuvette once a week in order to avoid the dirt in cuvette influence the test result. Carry out Rinsing
cuvette function when cell blank value abnormal, if cell blank value is still not qualified after Rinsing, replace
the cuvette.
12.2.8 Rinsing ISE

Select Rinsing ISE key, and click execute after ISE device is well connected. Instrument will
automatically rinse ISE system (Dilute bath and ISE pipeline), click end maintenance key to end this
operation.
We suggest user execute Rinsing ISE once a day after analyze finish. ISE calibration must be execute before
next test.
Note : If ISE device is not connected, or connected but not set, all ISE maintenance cannot be used, the hint
bar may hint: please check if ISE device can be used.
12.2.9 Rinsing ISE+ Reaction cuvette

If ISE device is well connected, select Rinsing ISE+ Reaction cuvette key, click execute key, instrument
will rinsing reaction cuvette and ISE system (Dilute bath and ISE pipeline) together. Click end maintenance
key to end this operation.
We suggest user execute Rinsing ISE + Reaction cuvette once a week. If rinsing all is executed, rinsing ISE +
Reaction cuvette should not be carried out again.
12.2.10 Rinsing incubation bath

Click Rinsing Incubation bath function in Maintenance item list. And then click Execute .The
instrument will automatically carry out the whole process, expel the water from the incubation bath and infuse
new purified water. Meanwhile, reagent probe 1 and reagent probe 2 will suck the CS-anti-bacterial phosphor
free detergent at 45 position of reagent 1 disk and reagent 2 disk. Each probe suck 6 times, each time 500ul. 6
ml CS-anti-bacterial phosphor free detergent is added in the incubation bath. Stop is not allowed in this
operation.
Carry out incubation bath water replace function when constant temperature water is contaminated. Incubation
bath will automatically replace water when instrument start up. If the instrument is continuously used for more
than 24 hour, alarm issued to hint to carry out the incubation bath water replace function.
12.2.11 Sample probe vertical checkup

Select sample probe vertical checkup function, click Execute, instrument will carry out single-step vertical
operation of sample probe lift mechanism. Click next to proceed next operation, click end maintenance to
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stop the maintenance operation. Stop is not allowed during maintenance operation, take other operation when
computer stand-by.
For detail introduction of sample probe vertical checkup, please refer to 12.4.1(4).
Figure 12-3
12.2.12 Sample probe horizontal checkup

Select sample probe horizontal checkup function, click Execute, instrument will carry out single-step
horizontal operation of sample probe lift mechanism. Click next to proceed next operation, click end
maintenance to stop the maintenance operation. Stop is not allowed during maintenance operation, take other
For detail introduction of sample probe horizontal checkup, please refer to 12.4.1(4).
This operation is taken when carry out sample probe position adjustment or sample probe position checkup.
12.2.13 Reagent probe vertical checkup

Select reagent probe vertical checkup function, click Execute, instrument will carry out single-step
vertical operation of reagent probe lift mechanism. Click next to proceed next operation, click end
maintenance to stop the maintenance operation. Instrument will automatically memorize the altitude of the
test, and this would view as reference value to calculate the remaining volume of reagent. Stop is not allowed
during maintenance operation, take other operation when computer stand-by.
For detail introduction of reagent probe vertical checkup, please refer to 12.4.1(4).
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12.2.14 Reagent probe horizontal checkup

Select reagent probe horizontal checkup function, click Execute, instrument will carry
out single-step horizontal operation of reagent probe lift mechanism. Click next to proceed
next operation, click end maintenance to stop the maintenance operation. Stop is not allowed during
maintenance operation, take other operation when computer stand-by.
For detail introduction of reagent probe horizontal checkup, please refer to 12.4.1(4).
This operation is taken when carry out reagent probe position adjustment or reagent probe position checkup.
12.2.15 Stirring mechanism horizontal checkup

Select stirring mechanism horizontal checkup function, click Execute, instrument will carry out
single-step operation checkup of stirring rod lift mechanism.
This function is carry out when adjust the stirring mechanism position (at the side of cuvette or on the top of
rinsing bath).
12.2.16 Mechanism operation checkup

Select mechanism operation checkup function, input check times, click Execute. Instrument will
automatically carry out mechanism operation checkup.
Alarm issued to hint to carry out the mechanism operation checkup

Click bar code reader checkup function, list all kinds barcode in system maintenance: reagent disk barcode
checkup, sample disk barcode checkup, select one of them and click Execute key. Click end maintenance
button to complete scan. Figure 12-4 explain the reagent disk barcode scan and sample disk barcode scan:
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Figure 12-4
12.2.18 ISE checkup

Select ISE checkup function, input check times, and click Execute. The check value can be displayed in
the result work area, click end maintenancekey to end the operation.
Execute ISE checkup when exchange electrode or after issue ISE alarm.
Note: The difference of two test value of same electrode should be less than 0.2.
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Figure 12-5 ISE check
12.2.19 ISE rinsing reagent pipeline

Select ISE Rinsing reagent pipeline function in Maintenance item list menu, and click Execute key.
Click end maintenance key to end this operation.
We suggest user execute SIE rinsing reagent pipeline once a month.
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Figure12-6
12.2.20 ISE pipeline exhaust
Single-click in main keypad and select ISE pipeline exhaust, and then execute, the
instrument will carry out pipeline exhaust automatically after implement this function when bubbles exist in
ISE pipeline and ISE injection pump.
12.2.21 Automatically rinse the pipeline of concentrated liquid

The centrifuged serum may contain fibrin to make concentrated waste liquid pipeline blocked if the serum
sample are not concreted completely when testing, or blocked by bacteria that may be growing it. After test
10000 samples, upper machine software automatically prompts: "Please rinse concentrated waste liquid
pipeline", and execute rinsing as following steps:
(a) Replace the CS-phosphor-free anti-bacterial cleaning liquid at the positions 45th of R1 reagent and R2
reagent disks with CS-solenoid valve cleaning liquid.
(b) Single-click in main keypad and select Automatically rinse concentrated waste liquid
pipeline, and then single-click Execute, the instrument will carry out pipeline rinsing automatically as
figure 12-7 shows:
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Figure 12-7
12.2.22 Manually rinse concentrated waste liquid pipeline

When concentrated waste liquid pipeline is dirty, execute manual rinsing of the pipeline as following steps:
(a) Clamp the concentrated waste liquid outlet at the right lower side of instrument back cover board with a
hemostatic clamp (about 50mm away from the back cover board).
(b) Unplug the nozzle 1 of rinsing mechanism first as figure 12-8 shows:
Nozzle 1
Figure 12-8
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(c) Take a 70ml reagent bottle (containing CS- solenoid valve cleaning liquid and make sure the distance
between liquid level and bottle lip is approximately 20mm), and insert nozzle 1 into the bottle, and then
single-click key, then select Manually rinse concentrated waste liquid pipeline, afterwards,
the instrument will execute rinsing automatically after click Execute as figure 12-9 shows:
Figure 12-9 Rinse concentrated waste liquid pipeline
(d) After about 5~6 minutes, remove the clamp on the outlet of concentrated liquid, and waste liquid will be
discharged automatically after rinsing.
(e) Replace the CS-reagent solenoid valve cleaning liquid in the 70ml bottle with purified water, and repeat the
operation carried out above.
12.3 Maintenance and checkup points and parts
12.3.1 Periodic cleaning, checkup and parts replacement

Table 12-5 gives periodic cleaning and replacement parts (based on use of 5 hours daily).
(: denotes periodic cleaning and check up and : denotes periodic replacement part.)
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Frequency
Quantity Yearly
No Part Refer to
Per use Quantity Every 3 Every 6
Daily Required Weekly Monthly Yearly
month month
1 Sample cup
2 Sample probe 12.4.1
3 Reagent probe 12.4.1

Rinsing bath of
reagent probe
4
Rinsing bath of
sample probe
12.4.1
Rinsing bath of
stirring rod
5(a)
Reaction cuvette sets
20pcs*6set
6set 72set 12.4.2
6
Drain filter of the
incubation bath
12.4.2
7(b) Halogen lamp 1 2 12.4.3
8
Rinsing mechanism
nozzle
12.4.4
9 Stirring rod 12.4.5
10
Sample probe syringe
Reagent probe syringe
12.4.11
11 Water supply filter 12.4.6
CS-anti-bacterial
12 phosphor free 12.1.3
CS-alkaline detergent
13 Vacuum tank 12.4.7
14 Cooling water bath 12.4.8
15
Reagent cooling unit
Sample cooling unit
12.4.9
16 Cooling fan 12.4.10
17(c) Printer ribbon cassette specificat

ion
18(d) Cell blank check 12.2.4
19(e)
Purified water
equipment
specificat
ion
20 Waste discharge
21 Detergent bottle 12.4.2
Table 12-1 Periodic Cleaning, Checkup and Parts Replacement List
Note:
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(a) Statistics in above table is a maximum statistics, if cell blank value is still qualified after 1 month,
continue to use it, if cell blank value is abnormal after Rinsing, replace it.
(b) Replace the lamp as soon as the photometer check value (340nm wavelength) exceeds 18,000 hours, or
the lamp use time more than 750 hours
(c) Instrument could use laser, ink mist, stylus printer, select accessory according to different printer.
(d) A cell blank alarm may occur if cell blank is not executed every week
(e) If the purified water has exceeded 1us/cm, consult the water supplier
12.3.2 Periodical replacement parts list

Make it a rule to stock as many spare parts as necessary for operation.
Quantity to
item Model name Description
Stock
1 Halogen lamp (light source lamp) 12V 20W 2
2 Reaction cuvette set20pcs6set 72set
3 3603 ethylene tube 1/81/4 inch 5m
4 3603 ethylene tube 1/161/8 inch 5m
5 Teflon FEP rigid tube 1.5mm2.5mm 5m
6 Teflon FEP rigid tube 0.031/16 inch 3m
7 Silica gel tube 8mm14mm 10m

Proper
8 Ribbon cassette For printer
amount
Proper
9 Printing paper For printer
amount
For supply water
10 Water supply filter 1
connection
11 Sample probe For sample 1
12 Reagent probe For sampling 2
13 Stirring rod For stirring 2
14 Nozzle 1, 2 of rinsing mechanism For cleaning 2

R1 reagent probe
15 R1 reagent probe syringe 1
sampling
R2 reagent probe
16 R2 reagent probe syringe 1
sampling
Sample probe
17 Sample probe syringe 1
sampling
Table 12-2
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12.4 Maintenance and check up method
Warning:
Do not spill water, reagent or detergent over the instrument or mechanical /electrical parts in order to
avoid the damage.
Do not touch the suction mechanism, sampling mechanism, stirring mechanism, reaction cuvette rinsing
mechanism during operation, or there will be a risk of infection or injury.
Protective measures should be taken to the operator, such as with protective gloves, protective glasses
and work uniform during operation. Otherwise, there maybe an infection when touch the contaminated
areas and contaminated liquid. Corrosive liquids may cause a skin injury. If the contaminated liquid or
corrosive liquids accidentally touched the body, please rinse with water immediately, and seek medical
advise.
12.4.1 Sample probe and reagent probe

If the probe inside or outside is contaminated, the serum, reagent, water, etc. might easily adhere, thereby
degrading the sampling accuracy and precision or clogging the interior. Wash or clean the probe from time to
time.
(1) Daily washing (automatic washing)
(a) Remove the sample disc cover, place 1ml CS-alkaline detergent (as figure 12-10 shows) on W1 position
of sample disc. Placed 1ml CS-acidity detergent on W3 position to avoid cross-contamination. Detergent
quantity should be taken according to the frequency of rinsing.
Figure 12-10
(b) Set 70ml CS-anti bacterial phosphor-free detergent on 45 position in the reagent disc(R1,R2).
When sample and reagent probe finish sampling respectively, they may automatically assimilate CS-anti
bacterial phosphor-free detergent or CS alkaline detergent to process the rinsing.
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Note: Place the detergent on a designated position When doing cuvette, sample probe avoiding
cross-contamination rinsing.
Figure 12-11
(2) Cleaning outside of probe tip
(a) Turn off the POWER switch of analyzer.
(b) Remove the sample or reagent disk cover, and move the probe arm to the top of disk by hand.
Figure 12-12
(c) Using gauze moistened with alcohol solution, clean the outside of probe.
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Figure 12-13
(d) Turn on the POWER switch of analyzing unit. Each probe will then return to its reset (home) position
automatically.
Note: As alcohol is flammable, Pay attention to it and do not place large amount alcohol in the vicinity of
the instrument.
(3) Cleaning clogged probe
(a) Turn off the POWER switch of analyzing unit
(b) Pinch the jaw of probe arm and remove the cover, and loosen the connector as figure 12-14 shows:
Jaw
Figure 12-14
Loosen the probe retaining nut as figure 12-15 shows.
Tube
Figure 12-15
(c) Remove the probe.
(d) Connect the end of needle cleaner with the probe connector on the connection well as shown in Figure
12-14, thereafter, take a clean standard tube and infuse sodium hypochlorite into the tube, henceforth, put the
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probe top into the solution and pull syringe piston to suck the cleaning fluid which should be discharged
after it retains in the needle for 5 minutes. If the probe is still cloted, repeat the action of pulling and pushing
the syringe piston after 5 minutes immersing of the probe in hot water .
Figure 12-14
(e) Followed the steps (d), if no liquid comes out of probe top, which indicats that probe is severely cloted,
which needs the penetration of acupuncture needle through the probe tip as shown in Figure 12-15:
Figure12-15
Repeat step (d) with needle cleaner assembly after clean-up.
(4) Adjusting probe position
(a) Turn on the POWER switch of analyzer
(b) Open the system maintenance menu
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(c) Click sample probe horizontal checkup, sample probe vertical checkup , reagent sample horizontal
checkup and reagent sample vertical checkup in the maintenance item.
Note: During adjusting sample probe, make sure to implement the horizontal checkup firstly, then implement
the vertical checkup. The tip of sample probe should be at the center of the reaction cuvette.
(d)During sample probe horizontal checkup, the probe stops above the reaction cuvette. At this step, adjust
the reagent probe so that its tip will be aligned with the center of reaction cuvette.
Reaction
cuvette
Probe tip
Figure 12-18
Please contact maintenance man if the probe tip is not aligned with the center of reaction cuvette.
(e) During reagent probe horizontal checkup, the probe stops above the reaction cuvette. At this step adjust
the reagent probe so that its tip will be aligned with the center of the reaction cuvette.
(f) To execute stirring mechanism horizontal checkup , when the stirring rod stops above the reaction
cuvette, at this step, check muddler probe tip is aligned with the center of reaction cuvette.
From overlooking angle to view the sample probe and reagent probe and stirring rod, the relevant position of
the reaction cuvette is as following:
Figure 12-19
Click end maintenance key to end operation
Please contact maintenance man if the probe tip and stirring rod probe tip are not aligned with the center of
reaction cuvette.
Process of sample probe up-down mechanism horizontal check:
The movement of the sample probe:
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Sample probe above the reaction cuvette Rinsing bath (pause) outer track 1 position on sample
disk(descend) above the reaction cuvette Rinsing bath (pause) Middle track W1 position on sample
disk (descend) Above the reaction cuvette Rinsing bath (pause) Inner track C8 position on sample
disk (descend) Above the reaction cuvette Rinsing bath (pause) ISE diluent bath Above the
reaction cuvette repeated the whole process.
Note: ISE diluent bath Above the reaction cuvette action only be taken where ISE function is provided.
Home position of the sample probe is reset point.
Process of reagent probe up-down mechanism horizontal check:
The movement of the Reagent probe:
Reagent probe (R1,R2) Above the reaction cuvette Rinsing bath Reagent bottle Rinsing bath
(pause) Above the reaction cuvette repeated the whole process.
*Sample probe R1 and R2 have the same movement according to the sample probe movement.
The movement of the Stirring rod
Stirring rod Above the reaction cuvette Rinsing bath Above the reaction cuvette repeated the
whole process.
R1,R2 have the same movement according to the Stirring rod movement
(g) Sample probe vertical check.
Select sample probe vertical check, in maintenance key, and then click Execute key, thus, the sample
probe descends until the bottom of sample cup is detected.
(h) During reagent probe vertical checkup, place an empty and dry reagent bottle at position 1 on reagent
disk 1 and reagent disk 2, single-click next, the reagent probe will descend from top to the bottom to
memorize the descent distance as the reference value of the remaining reagent.
(5) Cleaning rinsing bath
(a) If the Rinsing bath is contaminated, use a tube brush cleaning it with 2% CS-anti-bacterial phosphor-free
detergent as figure 12-20shows:
Rinsing bath
Figure 12-20
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(b) Infuse 10ml 2% CS-anti-bacterial phosphor-free detergent into Rinsing bath.
Figure 12-21
(c) Then, infuse 100ml water into Rinsing bath to wash.
After cleaning, contamination can be eliminated and bacterial can be restrained. Cleaning can be taken every
month. If the instrument is contaminated while the operation, please cleaning it in time.
12.4.2 Reaction cuvette

A contaminated reaction cuvette or incubation bath would cause faulty data. Beside, reaction cuvette get
aging after a long period usage. Periodically rinsing reaction cuvette, check the cell blank value of reaction
cuvette, if cell blank value is abnormal, replace the reaction cuvette .
(1) The confirmation of the contaminated Reaction cuvette
(a) Turn on the POWER switch of analyzer.
(b) Select cell blank function in the Maintenance menu, click Execute, the instrument will carry out
the cell blank check automatically.
(c) The cell blank value of the first reaction cuvette should 18000, and the difference between 2-120
cuvette should within the range of 800.
The cell blank value is the absorbency of each reaction cuvette before adjust the photometer, data value
represent the absorbency of each reaction cuvette from the second reaction cuvette, data value represent the
margin between each reaction coveter (from the second reaction cuvette) and the first reaction cuvette.
(d) If the cell blank value is not within a rage of 800, the relevant reaction cuvette is contaminated. Clean
the reaction cuvette.
Note: The cell blank value can be displayed or printed(previous value will be replaced when the second test
finished)
(2) Reaction cuvette cleaning
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If the cell blank value is not within a rage of 800, the relevant reaction cuvette is contaminated. Clean the
reaction cuvette. If the usage of the reaction cuvette has exceed the time limit for replacement, please place a
new one.
(a) Place the CS-anti-bacterial phosphor free detergent (70ml/bottle) on position 45 in the R1, R2 reagent
disk
(b) Click Rinsing reaction cuvettebutton in maintenance item list work area, then click Execute key.
(c) After cleaning reaction cuvette, carry out the cell blank check again. If the cell blank value exceeds the
800, please place a new one.
Note: In order to avoid uncleanness cleaning after long time use, immerse the reaction cuvette in 2% CS
anti-bacterial phosphor-free detergent for more than 8 hours every week. Wash the immersed reaction cuvette
with water, and then wash the reaction cuvette with purified water, and then mount the cuvette on the reaction
disk, carry out cell blank check, test after cell blank check value is qualified.
(3) Replace reaction cuvette.
If the blank cell value is not qualified after cleaning or if the cuvette is used for over two month, replace it
with a new one.
Note: A new reaction cuvette should be immersed in 2% CS-anti-bacterial phosphor detergent for 8 hours,
clean the surface of the cuvette by purified water, and then Mount the cuvette on the reaction disk, carry out
testing. The abnormal cell blank value will influence the accuracy and repetition of the testing result.
(a) Turn off the power switch.
(b) Remove the setscrew of rinsing mechanism when wear protective gloves.
Figure 12-22
(c) Remove the setscrew of reaction cuvette as figure 12-23shows.
213
Figure 12-23
(dTake out six set reaction cuvette as figure 12-24 shows:
Figure 12-24
(e) Mount new reaction cuvette on the reaction disk. 6 sets reaction cuvette should be placed at the same
time in counter direction.
(f) Turn on the power switch.
(g) Select cell blank test in maintenance menu. Make sure carry out the cell blank check after replace
reaction cup. Testing can be carried out after the cell blank value is qualified.
Note 1: A once-employed reaction cuvette might be contaminated heavily if allowed to dry. Immerse it in
purified water to store it. If the instrument will be left unemployed for 3 days or more, remove the reaction
cuvettes from the reaction disk and keep them immersed in purified water.
Note 2: Never use any organic solvent (benzene, alcohol) for washing the cuvettes.
(4) Cleaning Incubation Bath and the drain filter of the Incubation Bath.
A clog on drain filter or Incubation contamination will cause the inaccuracy of the testing data. Thus, Clean the
incubation bath periodically. (once a month)
(a) Select Rinsing incubation bath function in the maintenance item list work area, after closing the
214
light source lamp, the constant temperature water will be drained from the Incubation bath. Turn off the
power switch.
(b) Loosen the rinsing mechanism retaining screw, and remove the rinsing nozzle head, as figure 12-25
shows:
Figure 12-25
(c) Take out the 6 set reaction cuvette into purified water, Loose the retaining screw of the reaction disk, take
out the reaction disk. Place the reaction cuvette in a location free from dust.
Note: If take out the reaction disk and cuvette at the same time, water droplet attached on the outside of
reaction cuvette will drop into the instrument so that cause the instrument malfunction. Therefore take over the
reaction cuvette firstly and then take over the reaction disk secondly.
(d) Using washed gauze moisturized with water, clean the reaction bath and photometric window as figure
12-26 shows. Be careful not to flaw them or attached scrape.
Photometry
window
Figure 12-26
(e) Take out the drain filter of the incubation bath as figure 12-27 shows, cleaning by water, and then return
it in place.
215
Filter
Figure 12-27
(f) Click next key in the maintenance form, infuse pure water into the incubation bath, turn light and
circulation syringe power on.
(g) Mount the reaction disk and reaction cuvette after Incubation bath rinsing.
(h) Return the rinsing mechanism nozzle head in place and secure it.
(i) Select cell blank check function in maintenance item list work area. Test can be carried out after the
cell blank check value is qualified.
(5) Liquid level sensor of the incubation bath
Take out the sensor out of the incubation bath, wipe the outside of sensor with gauze moisturized with 2%
detergent. In order to prevent water from being contaminated by sensor probe, rinsing once a month is advised.
(6) Cleaning detergent bottle
As the CS-alkaline detergent in the detergent bottle is added timely and by this way maintain the day-to-day
use. After a period of time, there will be dust or white substance separate out Thus, clean it up monthly.
(a) Take over the detergent bottle from the instrument, loose the detergent bottle cap which is located on the
upper sprue. Insert the accessory tool from upper sprue to bottom outfall, then tighten the screw to prevent
leakage when detach the interface of the bottle bottom. Clean the bottle when there is only a few detergent
existed.
216
Bottle lid
Figure 12-28
(b) Detach the bottom interface after rag prepared, Take care that the pipe port position must be lower than
bottle.
Pipe joint
Figure 12-29
(c) Take out the detergent bottle, clean the outside and inside of the bottle, then wash it by water, At last
wash it by purified water. Detach the tool and wash away the attached detergent.
(d) Dry the inside water droplet, wipe the outside water droplet, return the detergent bottle in place, add
CS-alkaline detergent.
(e) Select maintenance item list work area, implement "pipeline for pouring detergent exhaust" function.
12.4.3 Light source lamp

If the light source lamp deteriorates, the quantity of light would be out of the specified photometric range or
noise would increase so that an accurate measurement would be impossible. If the check value exceeds,
replace the lamp.
(1) Light quantity check
217
Select Light quantity check function in maintenance form. The photometer light quantity is checked
and the results will be displayed by AD value or printed out.
Usually the value is a maximum at 340nm.
(2) Replace the light source lamp
Method 1:
(a) Prepare a new lamp.
Figure 12-30
Note: Do not touch the glass surface of the new lamp. Otherwise the lamp characteristics may change. If the
glass surface is found stained with fingerprints, etc, wipe them off with gauze wetted with alcohol.
(b) Select Rinsing incubation bath function, click Execute key, the constant water in incubation bath is
automatically discharged.
(c) Wait a few minute, cooling light room (30 minute).
(d) Loosen the retaining button of the reaction disk, take out the reaction disk. Place the reaction disk in a
position free from dust.
Note: Reaction disk should be placed in dry and clean area, prevent the droplet on reaction cuvette dropping
on the inside of the instrument.
(e) Loosen two retaining terminals of lamp lead wire and disconnect the lamp lead wires.
Retaining
terminal
218
Figure 12-31
(f) Loosen the retaining screw of the retaining light seat, take out the lamp as figure 12-32 show.
Retaining
screw
Figure 12-32
(g)In the reverse order of step 6-8, mount the new light source lamp. Do not distort the rubber tube used for
cooling light room. Make sure that the lead wire of the lamp not in loose status.
(h) Mount the reaction disk and cuvette and the Rinsing mechanism, turn the power on, execute next in
maintenance, infuse pure water into reaction cuvette. Execute light volume check function. While light
volume value is qualified, testing can be proceeded.
Method 2:
(a)~(c) are the same as above mentioned.
(d)Take over a set reaction cuvette instead of Rinsing mechanism. Keep the reaction cuvette clean. Turning
the reaction disk by holding the retaining button of the reaction disk, make the reaction disk, which is
detached from reaction cuvette turning underneath the Rinsing mechanism. Loosen the retaining button and
take over the reaction disk.
Following steps are the same as Method 1.
12.4.4 Cleaning the rinsing nozzle

If the rinsing nozzle clogs, the reaction cuvette may not be cleaned adequately so that cause a data error or
other instrument malfunction. Beside, rinsing water may overflow on the reaction disk to make it impossible to
provide correct data.
(a) Loosen the rinsing mechanism retaining screw by turning it counterclockwise, and remove the rinsing
nozzle head.
219
(b) Wipe the outside of the nozzle with gauze wetted in 2% anti-bacterial phosphor-free detergent.
Nozzle
Wipe block
Figure 12-33
Note: If the nozzle chip is contaminated heavily or worn excessively, replace it with a new one.
(c) Take out wiping block lightly, rinse it with pure water after rinsing it with 2% CS-anti-bacterial
phosphor-free detergent.
(d) Return the wiping block (keep lower horizontal level of wiping block the same level with the rinsing
probe) as figure 12-34:
Rinsing nozzle
Press
into
Nozzle
Reaction
cuvette
Figure 12-34
220
(e) Mount the rinsing mechanism in home position.
(f) Carry out the Mechanism Check 10 times, wiping block cant touch the reaction cuvette and the rinsing
water is filled up to the upper limit level in the reaction cuvette and it does not overflow from the incubation
bath.
12.4.5 Stirring rod

(1) Cleaning the Stirring Rod
A contaminated stirring rod would cause a cross contamination so that influence the accuracy and precision of
the testing result. Clean the Stirring Rod periodically.
Wipe the Stirring rod using gauze moistened with 2% anti-bacterial phosphor-free detergent, then wash away
the detergent on the surface of the Stirring rod by gauze moistened with purified water.
Caution: Do not bend the Stirring Rod.
Figure 12-35
(2)Replacing the stirring rod
(b) Loosen the two setscrews one round as figure 12-36 shows.
221
Figure 12-36
(c) wipe front of the new stirring rod with gauze moisturized with 2% CS-anti-bacterial phosphor-free
detergent.
(d) Insert the new stirring rod until its end touches the bottom of axis motor. Then, secure it by M2 as figure
12-37 shows.
Stirring rod
Motor
M2 Screw Stirring rod
Figure 12-37
(e) Place stirring rod adjust block on the rack of reaction cuvette, then move the stirring rod above the adjust
block as figure 12-38 shows.
222
Stirring mechanism
Reaction cuvette
71 position
Height adjust screw
Place the adjust block here
Adjust block
Figure 12-38
(f) loosen M2 screw, adjust the stirring rod position, its tip and upper side of adjust block are supposed to be
attached as figure 12-39 shows: tighten M2 screw.
Stirring rod
Adjust block top

Reaction cuvette tray
Figure 12-39
(g) Select stirring mechanism horizontal check in maintenance form, single-click Execute, next to
confirm stirring rod position weather correct. Please contact with after service.
(h) Execute 10 times mechanism movement check to confirm no abnormality exists.
12.4.6 Supply water filter

The main function of the supply water filter is to prevent the rubber grain and ion exchange resin get into the
inner line of instrument. If these filters are clogged, water supplied to the incubation bath and water used for
probe/ stirring rod rinsing are decreased significantly so that cause a data error. To prevent this, clean them
every month.
(a) Turn off the purified water supply unit to stop the water supply
(b) Turn off the power switch of analyzing unit.
(c) Make the gauze as a cushion of the filter cap, Loosen the filter cap. Prepare a water container to receive
the water flow.
223
Figure 12-40
(d) Pull out the filter, rinse the filter with water. Then reassemble it in the reverse order of the above.
12.4.7 The vacuum tank

Vacuum tank must be emptied if the waste liquid spills into a vacuum tank. Otherwise, abnormality of other
parts may occur (Contact the company after-sales service staffs when instrument abnormality occurs).
(a) Switch off the instrument main power.
(b) Loosen the two fixing screws of rubber hose on the back of the analyzer, and remove the hose as figure
12-41 shows.
(c) Unplug the cork and collect the outflow waste liquid with barrel or kind of containers.
Two fixing screws of rubber hose
Figure 12-41
(d) Plug the cork of rubber hose after empty the vacuum tank, and fix the hose on the cover with the two
screws.
224
12.4.8 Cooling water tank

Cooling water tank is located in the front left of instrument, and constant temperature water tank is located in
the lower left of the instrument.
(1) Adding purified water in water tank
If water in the cooling water tank is used many times, it will be dirty and will be in bad water circulation, and
the volume will be reduced due to evaporation To prevent this, exchanging water in the cooling water bath
once a year is a must.
(a)Turn off the power switch of analyzer.
(b)open the left front door of the instrument, remove the cover of front left lower side of the instrument.
Figure 12-42
(c) Remove the rubber plug from the cooling water bath, and drain water using the hose pump (prepare a
water reservoir or bucket).
High level tube
Low level tube
Figure 12-43
(d) Fill purified water into the cooling water bath until purified water spills out of the high level of the hose.
225
(e) Switch on the main power for several minutes. Replenish purified water again into the low water level of
hose until the purified water spills again from the high level of the hose (approximate 3L water).
(f)recover the rubber plug.
(g)Return the cover of the analyzer in place.
(2) Discharge the purified water in constant temperature water tank.
In case of transportation, discharge the purified water in the cooling water tank first.
(a) Turn off the main power supply of instrument.
(b) Demount the front left cover of instrument. Pull of the rubber plug as figure 12-44 shows.
Constant
temperature
Water tank
Robber plug
for hose
Figure 12-44
(d) Fill in the rubber plug after discharge the water, and mount the cover of instrument.
12.4.9 Reagent cooling unit and Sample disk tray

The reagent cooling unit and the sample disk tray will be contaminated with sample or dust. Clean them at
least once a month.
(a) Remove the reagent disk and clean the inside of the reagent cooling unit with gauze.
Reagent cooling unit

226
Figure 12-45
(b) Then, with gauze, clean the read-out window of the reagent barcode reader.
Barcode reader
window
Figure 12-46
(c) Remove the sample disk, and clean the inside of the sample disk tray with gauze.
Figure 12-47
12.4.10 Cooling fan and dustproof cover

Long-term use of the instrument can make the cooling fan and dustproof cover surface accumulated dust, so
every 6 months cleaning should be carried out once.
227
(1) Cooling fan cleaning
(a) Switch off instrument main power.
(b) Clean the dust on fan with vacuum cleaner.
(2) Dustproof cover cleaning
(a) Hold the handles of cooling fan at the both sides and remove the cover directly as figure 12-48 shows:
Handles of dustproof cover
Figure 12-48
(b) Clean the dust on the cover with vacuum cleaner.
(c) Rinse the cover with clean water.
(d) Remount the cover after wipe it with cloth.
12.4.11 Sample syringe

The Syringe includes R1 reagent probe syringe, R2 reagent probe syringe, sample probe syringe. If connected
with ISE, it may include SIP Syringe, DIL syringe, IS syringe too. The span of the syringe can be 1 million times,
and replacement is must in 15 months if use correctly. Contact the after service department in order to change a
new one.
12.4.12 Cooling machine

The cooling machine is at the rear of instrument, as figure 12-49 shows:
LED Display
228
Figure 12-49
The LED display of cooling machine will circulated display the circuit value of semi-conductor cooling chip
1-4, water tank temperature of cooling system, and instrument interior temperature.
When the temperature of water tank of cooling system < 5~15, or the C1-C4 current value is less than 5-7 A,
alarm will be issued, please contact after service department.
12.5 ISE device maintenance
12.5.1 Periodical cleaning, checkup and parts replacement

Periodic Cleaning, Checkup and Parts Replacement list
Table 12-3 gives periodic cleaning and replacement parts (based on use of 5 hours daily).
(:denotes periodic cleaning and check up and : denotes periodic replacement part.)
Frequency
Every Every Every Refer
No Item to
Daily Required Weekly Monthly 2 3 6
Month Month Month
1 Sample syringeSIP,IS,DIL 12.4.11
2 Vacuum tank 12.4.7
3 Sample pipeline rinsing 12.5.2
4 Waste pipeline rinsing 12.5.7
5 Reagent pipeline rinsing 12.5.3
6 Na electrode 12.5.4
7 K electrode 12.5.4
8 Cl electrode 12.5.4
9 Indicator electrode 12.5.4
10 SIP tubesuction tube 12.5.5
11 Cleaning of the waste 12.5.6
Table12-3
12.5.2 Daily rinsing

(automatically rinsing)
The pipe line could be contaminated by bacteria, fat and protein when testing electrolyte. Thus daily rinsing is
229
a necessity.
(a) Input 1ml CS-ISE detergent at W2 position in sample disk.
(b) Set rinsing after test in Maintenance menu as effective before the last test. If rinsing after test,
calibration should be taken when test ISE next time.
12.5.3 ISE reagent pipeline rinsing

(ISE infuse)
The ISE reagent pipeline could be contaminated after long time use. Rinsing it monthly according to the
following procedure.
(1) Carry out the infusion
(a) Dilute the CS-ISE detergent 20 times with purified water.
(b) Infuse the internal standard liquid, diluent bottle with above diluted CS-ISE, carry out ISE (IS+DIL)
infuse in maintenance menu.
(c) After infusion finished, wash out the CS-ISE detergent which attached on the tube with water, wipe out
the water droplet with gauze, and put it back..
(d) Carry out twice ISE(IS+DIL) infusion in system maintenance menu.
(2)ISE check up
Carry out 30 times ISE checkup in maintenance menu, and the result is showed.
Note : print value of the same electrode should within 0.2
12.5.4 Electrode replacement

Note:
Do not open ISE cover under normal situation, or temperature control error may cause test result inaccuracy.
Replace the electrode and check the instrument within 1 hour.
12.5.4.1 Na, K, Cl electrode replacement

After long time usage of ion selective electrode, the electric potential becomes weak, Thus replace a new
electrode is in need.
(1) Electrode replacement time
When slope value is abnormal, alarm will be issued, as table 12-4 shows:
Slope value
Alarm
Na K Cl
ISE prepare
above 68.1mV abov68.1mV below -68.1mV
abnormal
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68.1mV37mV 68.1mV37mV -68.1mV-32mV Normal
ISE prepare
37mV32mV 37mV32mV -32mV-25mV
abnormal
ISE slope value
below 32mV below 32mV above -25mV
abnormal
Table 12-4
When ISE prepare alarm issued, analysis of current day could be proceed as normal, replace a new electrode
next day. When ISE slope value error occur, replace a new electrode immediately.
If alarm issued even the slope value within normal rage, that indicates the electrode response error. This is
caused by pipeline contamination. Rinse the pipeline to solve this problem.
If the calibration value is normal in previous day, but slope value change rapidly now, do not exclude other
reasons except electrode error. Check if there is a leakage or block in the pipeline.
(2) Replacement method of electrode
(a) Open ISE cover at the left side of analyzer, turning-in the left side handgrip as figure 12-50 shows:
Hand shank
Figure 12-50
Remove the electrode by hand or by forceps after loosen the electrode as figure 12-51 shows:
231
Figure 12-51
(b) Pull out of the electrode lead, connect the colored lead after replace the new electrode. As figure 12-52
shows:
Reference Na+ K+ Cl-
Reference
Na+ K+ Cl-
Figure 12-52
(c)Range in Cl (green),K(red), Na(yellow), sequence, turning-in the handgrip.
Note 1: In order to prevent remaining of conductive component while replacing electrode, wipe out the
liquid in the vicinity of the electrode.
Note 2: In order to ensure gas tightness of electrode tube, a tube with O-ring is a must. Check if there is an
O-ring after replace new electrode.
(3) Electrode debugging
Debugging the electrode according to following sequence after replace a new electrode.
232
(a) Carry out ISE (IS,REF) infusion twice in maintenance menu.
(b) Carry out 10 times ISE checkup in maintenance menu ten minutes later. The result of the ISE checkup
will be showed in maintenance form.
(c) Carry out ISE (full point)calibration, check if the slope value in within reference range.
12.5.4.2 Reference electrode replacement

(1) Replacement time
When the slope value of Na, K, Cl are all unstable or lower, please replace a new one.
(2) Replacement method
(a) Open left ISE cover of analyzing unit pull-in the handgrip, remove any electrode of Na, K, Cl after loosen
the electrode.
(b) Pull out of the electrode lead.
(c) Remove the fixing block of reference electrode, as figure 12-53 shows:
Fixed Reference
block electrode
Figure 12-53
Note1: Push down the wrench on the side of Na, K, Cl electrode side, fix the fixing block, the electrode could
be pull out easily by doing so.
Note2: In order to easily replacement, nip the reference electrode by forceps.
Note3: Owing to the conductivity of the dropping liquid, wipe out the liquid by gauze wetted with purified
water.
(d) Replace new electrode, connect the electrode lead.
(3) Reference electrode debugging
233
(a) Carry out ISE (REF) infusion twice in maintenance menu.
(b) Carry out 10 times ISE checkup in system maintenance ten minutes later. The result of the ISE checkup
will be showed in maintenance form. The value difference of the same electrode should within 2Mv.
(c) Carry out ISE (full point) calibration, check if the slope value is within reference range.
12.5.5 SIP tube replacement

(a) Open the ISE cover of instrument analyze unit.
(b) Pull out of the tube and replace a new one. Make sure the tube is not slack while connecting. As figure
12-54 shows:
(c) Wipe out the dropping liquid with gauze wetted with purified water.
(d) Close the ISE cover.
SIP tube
Figure 12-54
12.5.6 ISE waste cleaning

The crystal substance attached on the ISE waste interface may cause inaccuracy of the test result. Cleaning it
once a week.
(a) Wash the crystal attached on the ISE waste interface into waste container by purified water, and then
wash the waste container by purified water. As figure 12-55 shows:
234
REF Tube Screw
Waste
interface
Waste
container
Detergent bottle
Figure 12-55
(b) Wipe out the liquid by gauze wetted with purified water, Thus there will be no conductive component in
the waste interface and waste container.
Note: Touching the waste tube may cause noise jamming while testing.
12.5.7 Waste pipeline cleaning

The sample probe, waste hose, electrode, ISE channel should be cleaned once a week.
(a) Place 1 ml CS-alkaline detergent at W1 position on sample disk, Place 1 ml CS-ISE detergent at W2
position on the sample disk.
(b) Place the CS-anti-bacterial phosphor-free detergent at 45 position on reagent disk 1 and reagent disk 2.
(c) Carry out Rinsing reaction cuvette + ISE in maintenance menu.
Note: Owing to the pipeline of electrolyte is cleaned at the same time, the electrode state may change, thus
carry out calibration before ISE test.
235
Chapter 13 Alarm Data Processing
13.1 Alarm information type
Alarm level includes: Warning level, sample stop level, stop level, as table 13-1 shows:
Alarm level Instrument action
Data alarm Alarm for testing result. Operation proceeds as normal.
Note appear both in data alarm and instrument malfunction. Buzzer calling, but the operation
Warning
proceed as usual, stop or proceed is judged by operator.
Alarm for instrument malfunction. Buzzer calling. Stop adding new sample. Sample on testing
Sampling stop
will proceed analyze.
Stop Alarm for malfunction. Buzzer calling. Instrument stop immediately. Test result is invalid.
Table 13-1
13.2 Countermeasure to malfunction do not issue alarm
13.2.1 Data malfunction which do not issue alarm

Some instrument malfunction is neither displayed in the data note nor issued the buzzer. These instrument
236
malfunction could be tested through recheck, observe instrument state and test control sample.
Dada malfunction and solution as figure 13-2 shows.
Malfunction Description Countermeasure
1.Maintenance according to the user manual.

2.Replace a new reagent, use or preserve it correctly.
1.Maintenance is not carried out periodically.
3.Water conductivity should within 1uS/cm.
2.Reagent deteriorate, insoluble matter exist
4.Add detergent, carry out rinsing reaction cuvette in
3.Purified water unqualified.
maintenance.
4.CS-anti-bacterial phosphor-free detergent,
Repeatability 5.Use detergent produced by Audit Diagnostics
CS-alkaline detergent shortage.
error Company.
5.Cristal occurs in reagent cooling unit. (low value
6.Separate place the reagent which may cause cross
repetitive error.)
contamination, or use cross contamination obviation
6.Cross contamination exist between analysis item.
function.
7.Sample disqualification, fibrin exists in sample.
7.Separate the disqualified sample, or collect sample
again.
1.Immediately use the standard liquid as long as its
1.Standard liquid concentrate failure.
put into the sample cup.
Accuracy error 2.Reagent concoct fault.
2.Replace a new reagent.
3.Analyze condition set error.
3.Correctly setup the parameter.
Table 13-2
13.2.2 Instrument malfunction which do not issue alarm
Malfunction Description Countermeasure
Sample probe with 1 Sample probe contaminated. 1 Clean it through maintenance check.
water droplet 2 Sampling system (pipeline, syringe) leakage. 2 Carry out maintenance check.
1 Fill it.
1 CS-anti-bacterial phosphor-free detergent for
2 Check interface
Water drop from cleaning reaction cuvette has run down
3 Clean it through maintenance check. For
washing mechanism 2 Rinsing mechanism pipeline leakage
replacement purpose, contact service
3 Nozzle and pipeline block.
department.
1 Outlet the air in pump.
Instant temperature 1 Water supply pump with air
2 Clean it through maintenance check.
Water do not 2 Incubation bath filter block.
3 Connect with power, do not use the same
outflow 3 Purified unit do not electrify.
circuit with instrument.
Clean it through maintenance check . For

Water cannot outflow
Nozzle, pipe line block. replacement purpose, contact the service
from Rinsing nozzle
department.
Water cannot outflow

from Rinsing bath
Rinsing outlet port. For replacement purpose
(sample probe, Outlet port, pipeline block.
contact the service department.
reagent nozzle,
stirring rod)
237
Constant temperature
water(from rinsing Clean it through maintenance check . For
mechanism to Nozzle, pipeline block. replacement purpose, contact the service
reaction cuvette) department.
overflow.
1 Incubation water level lower or incubation 1 Carry out water exchange in incubation
Incubation bath with bath is contaminated. bath
bubble. 2 Incubation water exchange carry out before 2 Carry out water exchange after purified
Purified water unit power on. water unit electrified
1 Radiator filter with dust block. 1 Clean it through maintenance check.

Reagent cooling error
2 Cooling unit malfunction. 2 Contact service department.
Sample syringe with

Interface installation error Re-install after leakage confirmed.
leakage
1 Re-install after air enter in confirmed

Sample syringe with 1 Interface installation error 2 Carry out again. If small air bubble exist,
bubble 2 Sample syringe degas insufficient tap the syringe while reagent or detergent
flow. Eliminate it with shake.
Table 13-3
13.3 Instrument alarm list
238
Code Level Name Describe Countermeasure
1.Check if the reagent is confected or positioned in the right way.

2.Check if the incubation bath is contaminated.
Absorbance The absorbance to be used for calculation
0-1 Warning 3.Check if there is the impurity interfuse.
over after cell blank correction exceeds 3.3ABS
4.Check if the reaction cuvette is blurred. 5.Check if there is an obstacle on the
optical path of photometer.
Reagent blank The mean value of two tests with standard

0-2 Warning horizontal solution 1 is larger than the setup value of Check if reagent is still valid.
checkup over. cell blank horizontal check.
The difference between two times test 1.Check if the value of deviation permissible absorbance is correct.
Divergence
0-3 Warning standard solution absorbance is larger than 2.Check if sample syringe is leakage and if the incubation bath is contaminated.
checkup over
deviation permissible absorbance. 3.Check if there is a cross contamination.
The difference between calculate K factor 1.Check if K factor is proper.
K factor check
0-4 Warning and previous one is more than plus or 2.Check if the standard solution is deteriorate.
value over
minus 20% 3.Check if reagent is deteriorate.
Technical limit The measured value is out of the technical 1.Dilution the sample and rerun the test.
0-5 Warning
over limit range of test item. 2.Check setup value.
1.Check if there is impurity in the sample.
Calculation in the specified photometric
Linearity 2.Check if there is impurity and bubble in the reagent.
0-6 Warning range, and there is a different exceeding the
abnormal 3.Dilution the sample and rerun the test.
linearity limit value.
4.Check Stirring mechanism.
Sensitivity is checked for linear(2-6

points), non-linear or Isozyme-P
1.Call up main screen, check if sensitivity limit value is properly setup.
calibration. This error is indicated if the
Sensitivity 2.Check if reagent is deteriorate.
0-7 Warning difference in mean absorbance between
abnormal 3.Check the input concentration value of standard solution is properly setup.
standard solution 1 and standard solution
4.Check if standard solution deteriorate.
(N) is smaller than the sensitivity limit
(input value).
239
In the Antigen addiction assay and reaction

1.Dilution the sample and rerun the test.
Prozone check assay, the prozone check value (PC
0-8 Warning 2.Check if the reagent is confected or positioned in the right way.
value over value),exceeds the specified upper/lower
3.Check if the specified upper/ lower limit is properly set up.
limit.
Absorbency In Rate A assay and Rate B assay, The 1.Test after dilute the sample.
0-9 Warning reaction limit check value of substrate is larger than the 2.Check if the reagent is confected or positioned in the right way.
over setup limit value. 3.Check if the check value is properly setup.
1.The denominator becomes zero in
calculation. 1.Check if there is a logical error in calculation formulas.
Calculation 2.An over flow occurs in logarithmic or 2.Check the concentration setup of standard liquid when multi-point
0-10 Warning
disable exponential calculation. calibration.
3.The absorbance of test item is less than 3.Check the absorbance value of photometry point of the test.
the absorbance of standard liquid 1.
In multi-point calibration, the absorbance 1.Check if calibration liquid is positioned in the right way.
Calculation
0-11 Warning of standard liquid do not increase when 2.Check if absorbance value of different concentrationis increase.
disable
concentration increase. 3.Please rerun the calibration.
ISE calculated In calculation the denominator became
0-12 Warning Please check if ISE reagent and sample are enough,and in right position.
error zero
ISE request New ISE calibration is required if overtime
0-13 Warning Execute ISE calibration
calibration calibration occurs in ISE calibration.
Concentrated
waste liquid Concentrated waste liquid pipeline need to Call up the system maintenance menu, carry out the program "Auto Rinsing
0-14 Warning
pipeline need to Rins Concentrated waste liquid pipeline"
Rins
1.Check the barcode stick information.
0-20 Warning Barcode repeat Barcode repeat on R1 disk
2.Scan barcode again after check.
Reagent R2 and
0-21 Warning R3 is found on Reagent R2 and R3 is found on R1 disk.
R1 disk.
240
Detergent
Detergent should be placed at 45 position
placed error at 1.Check the barcode stick information.
0-22 Warning on R1 disk.or barcode stick error at 45
45 position on 2.Scan barcode again after check.
position on R1 disk.
R1 disk.
1.when reagent residual volume is less than

R1 disk barcode setup reagent residual volume, the barcode 1.Check the barcode stick information.
0-23 Warning
blank out. is blank out. 2.Scan barcode again after check.
2.barcode is used after blank out.
1.Barcode checkup failure.

1.Check barcode stick information.
R1 disk barcode 2.Barcode reagent name do not occur in
0-24 Warning 2.Scan barcode again after check.
invalid "barcode item setup".
3.Corresponding item is added in barcode item setup.
3.Barcode reagent type checkup error.
R2 disk barcode 1.Check the barcode stick information.
0-25 Warning R2 disk barcode repeat.
repeat 2.Scan barcode again after check.
Reagent R1 and
0-26 Warning R4 is found on R1 and R4 detergent is found on R1 or R4
R2 disk
Detergent
Detergent should be placed at 45 position
placed error at 1.Check the barcode stick information.
0-27 Warning on R2 disk.Barcode stick error at 45
45 position on 2.Scan barcode again after check.
position on R2 disk.
R2 disk.
1.when reagent residual volume is less than
R2 disk barcode setup reagent residual volume, the barcode 1.Check the barcode stick information.
0-28 Warning
blank out. is blank out. 2.Scan barcode again after check.
2.barcode is used after blank out.
1.Barcode checkup failure.
1.Check barcode stick information.
R2 disk barcode 2.Barcode reagent name do not occur in
0-29 Warning 2.Scan barcode again after check.
invalid. "barcode item setup".
3.Corresponding item is added in barcode item setup.
3.Barcode reagent type checkup error.
241
ISE exceed the

ISE QC exceed the lower limit of Please check if Controls volume and reagent volume is enough, if the position is
0-31 Warning lower limit of
measuring range. right.
measuring range
ISE exceed the
ISE QC exceed the upper limit of Please check if Controls volume and reagent volume is enough, if the position is
0-32 Warning upper limit of
measuring range
ISE exceed the
ISE QC exceed the lower limit of Please check if Controls volume and reagent volume is enough, if the position is
0-33 Warning lower limit of
measuring range
ISE exceed the
ISE QC exceed the upper/lower limit of Please check if Controls volume and reagent volume is enough, if the position is
0-34 Warning upper limit of
measuring range
ISE exceed the ISE QC exceed the upper limit of Please check if sample volume and reagent volume is enough, if the position is
0-35 Warning
measuring range measuring range. right.
Communication Communication abnormal. No response 1.Check if serial port line is well connected.
0-254 Stop
abnormal when instruction send to host computer. 2.Restart the instrument and software and then carry out on-line instruction.
Communication Abnormal occur when communicate with 1.Check if serial port line is well connected.
0-255 Stop
abnormal host computer and communication halt. 2.restart the instrument and software and then carry out on-line instruction.
1.Call up the mechanism check screen and carry out the check program
R1 Stirrer The R1 stirring mechanism does not reach
"mechanism check.
1-1 Stop mechanism the upper dead point in ascending motion
2.Various malfunctions or trouble can not be restored. Contact the service
abnormal (at the rinsing bath side)
department.
"mechanism check.
abnormal ( at the reaction cuvette side)
department.
R1 Stirrer
The R1 stirring mechanism does not leave "mechanism check ".
1-3 Stop mechanism
the upper dead point in descending motion. 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
242
"mechanism check ".
1-4 Stop mechanism the rinsing bath position in movement to
abnormal the rinsing bath side.
department.
"mechanism check ".
1-5 Stop mechanism the reaction cuvette position in movement
abnormal to the reaction cuvette side
department.
R1 Stirrer
In resetting, the R1 stirring mechanism "mechanism check ".
1-6 Stop mechanism
does not reach the rinsing bath position 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
R1 Stirrer
1-7 Stop mechanism
does not leave the rinsing bath position 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
R1 Stirrer
In rotation of R1 stirring mechanism, it is "mechanism check ".
1-8 Stop mechanism
not set at the upper dead point. 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
R1 Stirrer
The R1 stirring mechanism has ascend "mechanism check ".
1-9 Stop mechanism
/descend error 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
R1 Stirrer
"mechanism check ".
1-10 Stop mechanism The R1 stirring mechanism has sway error
abnormal
department.
243
"mechanism check ".
abnormal (at the rinsing bath side)
department.
"mechanism check ".
abnormal (at reaction cuvette side)
department.
R2 Stirrer
The R2 stirring mechanism does not leave "mechanism check ".
2-3 Stop mechanism
the upper dead point in descending motion. 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
"mechanism check ".
2-4 Stop mechanism the rinsing bath position in movement to
abnormal the rinsing bath side
department.
"mechanism check ".
2-5 Stop mechanism the reaction cuvette position in movement
abnormal to the reaction cuvette side
department.
R2 Stirrer
2-6 Stop mechanism
does not reach the rinsing bath position 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
R2 Stirrer
2-7 Stop mechanism
does not leave the rinsing bath position 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
244
R2 Stirrer
In rotation of R2 stirring mechanism, it is "mechanism check ".
2-8 Stop mechanism
not set at the upper dead point. 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
R2 Stirrer
The R2 stirring mechanism has ascend "mechanism check ".
2-9 Stop mechanism
/descend error 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
R2 Stirrer
"mechanism check ".
2-10 Stop mechanism The R2 stirring mechanism has sway error
abnormal
department.
Rinsing
The rinse mechanism does not reach the "mechanism check ".
3-1 Stop mechanism
upper dead point in ascending motion 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
Rinsing
The rinse mechanism dose not leave the "mechanism check ".
3-2 Stop mechanism
upper dead point in the descending motion. 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
1.This trouble is liable to occur after the reaction disk is washed. In this case,
thoroughly wipe water droplets off the bottom of the reaction disk.
Reaction disk The reaction disk cannot detect the stop
4-1 Stop 2.Check if water droplets adhere to the light coupler and code wheel located
abnormal position.
below the reaction disk.
3.if trouble can not be restored, contact the service department.
Reaction disk The reaction disk does not stop at the
abnormal specified position
3.if trouble can not be restored, contact the service department.
245
Reaction disk In resetting, the reaction disk cannot detect
abnormal the home position
3.if trouble can not be restored , contact the service department.
In resetting, the first reaction cuvette on the thoroughly wipe water droplets off the bottom of the reaction disk.
Reaction disk
4-4 Stop reaction disk does not stop at the specified 2.Check if water droplets adhere to the light coupler and code wheel located
abnormal
position. below the reaction disk.
3.if trouble can not be restored , contact the service department.
In rotation of the reaction disk any of the
sample probe, reagent probe, stirring 1.Call up the mechanism check screen and carry out the check program
Reaction disk mechanism and rinse mechanism is not at "mechanism check".
4-5 Stop
abnormal the upper dead point (at the reaction 2.Various malfunctions or trouble can not be restored. Contact the service
cuvette side) Warning: any other alarm department.
may occur simultaneously
CS-alkaline
CS-alkaline detergent place in front of
4-6 Warning detergent Please add CS-alkaline detergent in detergent bottle.
instrument is shortage.
shortage
The sample probe does not reach the upper
Sample probe "mechanism check".
5-1 S .Stop dead point in descending motion.(at other
abnormal 2.Various malfunctions or trouble can not be restored. Contact the service
than the reaction cuvette side)
department.
The sample probe does not reach the upper
5-2 Stop dead point in descending motion.(at the
reaction cuvette side)
department.
Sample size is 1.Check if there is sample in sample cup.
5-3 Warning Insufficient in sample size is Insufficient in sample cup 2.check if sample cup place in the correct position.
sample cup 3.Check if sample cup is bend.
246

"mechanism check".
The sample probe goes down abnormally
Sample probe department.
5-4 Stop in descending motion (at the reaction
abnormal 3.Check if check the altitude between probe and cup bottom is set properly.
cuvette side)
4.Call up the system maintenance menu, carry out "sample probe horizontal
checkup".
5.Check if the sample cup is placed deflective.
The sample probe does not leave the upper
5-5 S. Stop dead point in descending motion.(at the
sample cup side)
department.
The sample probe does not leave the upper
5-6 Stop dead point in descending motion.(at the
reaction cuvette side)
department.
Sample probe Sample probe stay in liquid level detect
5-7 S. Stop Please contact service department when this error occur repetitively.
abnormal effective status.
The sample probe cannot detect the cell
5-8 S. Stop position in rotation to the reaction cuvette
side.
department.
The sample probe does not leave the 1.Call up the mechanism check screen and carry out the check program
Sample probe reaction cuvette position in rotation from "mechanism check".
5-9 S. Stop
abnormal the reaction cuvette side to any other 2.Various malfunctions or trouble can not be restored. Contact the service
position. department.
Sample probe Sample probe descend abnormally when "mechanism check".
5-10 S. Stop
abnormal discharge ISE test sample 2.Various malfunctions or trouble can not be restored. Contact the service
department.
247
Sample probe Abnormal touch occur (at the sample cup "mechanism check".
5-11 Warning
abnormal side) when sample probe descend. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample probe In rotation of reagent-1 probe, it is not set "mechanism check".
5-12 S. Stop
abnormal at the upper dead point. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample cup is
5-13 Warning Sample probe cannot find sample cup Check if there is sample cup on sample disk.
not placed
1.Check if there is obstacle on sample disk.
Sample probe Sample probe cannot reach sample liquid
5-14 S. Stop 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal when descend.
department.
Sample probe Sample probe mechanism ascend/ descend "mechanism check".
5-15 Stop
abnormal abnormal 2.Various malfunctions or trouble can not be restored. Contact the service
department.
5-16 Stop Sample probe mechanism sway abnormal
department.
Sample probe Detergent is not detected when sample
5-17 Warning Check if detergent is placed at W1, W2, W3.
abnormal descending.
Sample disk The sample disk does not detect the "mechanism check".
6-1 S. Stop
abnormal specified position on the outer track 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample disk The sample disk does not stop in the "mechanism check".
6-2 S. Stop
abnormal specified position on the outer track 2.Various malfunctions or trouble can not be restored. Contact the service
department.
248
Sample disk The sample disk cannot detect the stop "mechanism check".
6-3 S. Stop
abnormal position on the intermediate track. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample disk The sample disk cannot stop in the specific "mechanism check".
6-4 S. Stop
abnormal position on the intermediate track 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample disk The sample disk cannot detect the stop "mechanism check".
6-5 S. Stop
abnormal position on the inner track. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample disk The sample disk cannot stop in the specific "mechanism check".
6-6 S. Stop
abnormal position on the inner track 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample disk In resetting, the sample disk cannot detect "mechanism check".
6-7 Stop
abnormal the home position. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample disk In resetting, the sample disk does not leave "mechanism check".
6-8 Stop
abnormal the home position 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample disk In resetting the sample disk does not stop at "mechanism check".
6-9 Stop
abnormal sample 1 position on the outer track. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
sample barcode 1.Check if barcode device is well connected.
6-10 Warning Sample barcode reader cannot be found.
device abnormal 2.Trouble cannot be restored, Contact the service department.
249
Sample syringe The sample syringe is not at the upper dead "mechanism check".
7-1 S. Stop
abnormal point. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Sample syringe The sample syringe does not leave the "mechanism check".
7-2 S. Stop
abnormal upper dead point. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
R1 probe The R1 probe does not reach the upper "mechanism check".
8-1 Stop
abnormal dead point in ascending motion 2.Various malfunctions or trouble can not be restored. Contact the service
department.
1.Check if there is still reagent in the bottle.
2.Check if the reagent bottle is open.
R1 probe The R1 probe goes down abnormally in
8-2 Warning 3.Check if the reagent disk cover is put in its proper place.
abnormal descending motion
4.Check if the reagent-1 probe is bent.
5.Check if reagent bottle is lean placed.
R1 probe The R1 probe does not leave the upper "mechanism check".
8-3 Stop
abnormal dead point in descending motion 2.Various malfunctions or trouble can not be restored. Contact the service
department.
R1 probe R1 probe stay in liquid level detect
8-4 Warning Please contact service department when this error occur repetitively.
The R1 probe cannot detect the cell
R1 probe "mechanism check".
8-5 Stop position in rotation to the reaction cuvette
side.
department.
R1 probe The R1 probe cannot leave the cell position "mechanism check".
8-6 Stop
abnormal in rotation to the reaction cuvette side. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
250
R1 probe In rotation of R1 probe, it is not set at the "mechanism check".
8-7 Stop
department.
R1 probe
8-8 Warning R1 probe cannot find reagent bottle Check if there is reagent bottle on R1 reagent disk.
abnormal
R1 probe R1 probe cannot reach reagent liquid level 1.Check if there is obstacle on R1 reagent disk.
8-9 Stop
abnormal when descend. 2.trouble cannot be restored, contact the service department.
R1 probe R1 probe mechanism ascend/ descend "mechanism check".
8-10 Stop
abnormal abnormal 2.Various malfunctions or trouble can not be restored. Contact the service
department.
8-11 Stop R1 probe mechanism sway abnormal
department.
1.Call up the system maintenance menu and carry out the check program "reset".
R2 probe The R2 probe does not reach the upper
9-1 Stop 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal dead point in ascending motion
department.
1.Check if there is still reagent in the bottle.
2.Check if the reagent bottle is open.
R2 probe The R2 probe goes down abnormally in
9-2 Warning 3.Check if the reagent disk cover is put in its proper place.
abnormal descending motion
4.Check if the reagent-1 probe is bent.
5.Check if reagent bottle is lean placed.
R2 probe The R2 probe does not leave the upper "mechanism check".
9-3 Stop
abnormal dead point in descending motion 2.Various malfunctions or trouble can not be restored. Contact the service
department.
R2 probe R2 probe stay in liquid level detect
9-4 Warning Contact the service department when this error occurs repetitively.
251
The R2 probe cannot detect the cell
9-5 Stop position in rotation to the reaction cuvette
side.
department.
R2 probe The R2 probe cannot leave the cell position "mechanism check".
9-6 Stop
abnormal in rotation to the reaction cuvette side. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
R2 probe In rotation of R2 probe, it is not set at the "mechanism check".
9-7 Stop
department.
R2 probe
9-8 Warning R2 probe cannot find reagent bottle. Check if there is reagent bottle on R2 reagent disk.
abnormal
R2 probe R2 probe cannot reach reagent liquid level 1.Check if there is obstacle on R2 reagent disk.
9-9 Stop
abnormal when descend. 2.Trouble cannot be restored, contact the service department.
R2 probe R2 probe mechanism ascend/descend Various malfunctions or trouble can not be restored. Contact the service
9-10 Stop
abnormal abnormal department.
R2 probe R2 probe mechanism ascend/descend Various malfunctions or trouble can not be restored. Contact the service
9-11 Stop
abnormal abnormal department.
R1 disk "mechanism check".
10-1 Stop The R1 disk cannot detect the stop position
department.
R1 disk The R1 disk does not stop at the specified "mechanism check".
10-2 Stop
abnormal position 2.Various malfunctions or trouble can not be restored. Contact the service
department.
252
R1 disk The R1 disk cannot detect the home "mechanism check".
10-3 Stop
abnormal position. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Bar code device 1.Check if barcode device is well connected.
10-4 Warning of R1 reagent Barcode reader of R1 disk cannot be find 2.Various malfunctions or trouble can not be restored. Contact the service
disk abnormal department.
R1 reagent
10-5 Stop number R1 reagent number invalidity. Please contact the service department.
invalidity
R2 disk "mechanism check".
11-1 Stop The R2 disk cannot detect the stop position
department.
R2 disk The R2 disk does not stop at the specified "mechanism check".
11-2 Stop
abnormal position 2.Various malfunctions or trouble can not be restored. Contact the service
department.
R2 disk The R2 disk cannot detect the home "mechanism check".
11-3 Stop
abnormal position. 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Bar code device 1.Check if barcode device is well connected.
11-4 Warning of R2 reagent Barcode reader of R2 disk cannot be find 2.Various malfunctions or trouble can not be restored . Contact the service
disk abnormal department.
R2 reagent
11-5 Stop number R2 reagent number invalidity. Please contact the service department.
invalidity
R1 Syringe The R1 syringe is not at the upper dead
14-1 Stop When this error occurs repetitively, please contact service department.
abnormal point.
253
R1 Syringe The R1 syringe does not leave from the

abnormal upper dead point
R2 Syringe The R2 syringe is not at the upper dead
abnormal point.
R2 Syringe The R2 syringe does not leave from the
abnormal upper dead point
1.Call up the system maintenance menu,first carry out the program "reset",then
Electrolyte SIP SIP sipper does not reach the lower dead go on "mechanism check"
16-1 Warning
Sipper abnormal point (when reset and operate) 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Electrolyte SIP SIP sipper does not leave the lower dead go on "mechanism check"
16-2 Warning
Sipper abnormal point 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Electrolyte
The vacuum nozzle does not reach the go on "mechanism check"
17-1 Warning vacuum Sipper
lower dead point 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
Electrolyte
The vacuum nozzle does not leave the go on "mechanism check"
17-2 Warning vacuum Sipper
lower dead point. 2.Various malfunctions or trouble can not be restored. Contact the service
abnormal
department.
Electrolyte
SIP syringe does not at the upper dead
18-1 Warning sample Syringe Contact the service department.
point.
abnormal
Electrolyte
SIP syringe does not leave the upper dead
point.
abnormal
Electrolyte
The diluent syringe is not at the upper dead
point.
abnormal
254
Electrolyte
The diluent syringe is not leave the upper
dead point.
abnormal
Electrolyte
The internal standard solution syringe is
not at the upper dead point.
abnormal
Electrolyte
The internal standard solution syringe is
not leave the upper dead point.
abnormal
The ISE function stops due to an
go on "mechanism check"
19-1 Warning ISE stop alarm.Warning: Displayed if restart is
given in sample stop status.
department.
Incubation bath 1.Check if cooling fan is operate normally.
The water temperature in the incubation
20-1 Warning water temp 2.Check if colling fan dustproof cover is cloged by dirt
bath is over 45C
abnormal 3.Trouble can not be restored, contact the service department.
1.Check if the room temperature is within a range of 15-32C.
Incubation bath The water temperature in the incubation 2.Check if cooling fan is operated normally.
20-2 Warning water temp bath is over the range of 37 plus or minus 3.Check if cooling fan dustproof cover is cloged by dirt.
abnormal 0.5C.(check in operating) 4.Check if the incubation bath water is circulation.
5.Trouble can not be restored, contact the service department.
1.Clean liquid level sensor probe of incubation bath.
Incubator water The water level in the incubation bath is 2.Check if there are water in purified water machine and pipeline.
21-1 Warning
level error too low 3. Please restart the instrument.
4.If the trouble cann't be restored, contact the service department.
Incubation bath A period of 24 hours has passed since
22-1 Warning Carry out "Incubator water exchange" or restart the instrument.
water exchange exchanging water in the incubation bath.
Water level too The distilled water tank is not supplied with water, Check the water pressure,
23-1 Stop The water level in the water tank is too low
low water cock, and other water supply systems.
255
Waste water in The vacuum tank contains some waste

28-1 Warning Empty the water in vacuum tank according to theUser manual.
Vacuum Tank water
Reagent residual volume in R1 or R4
1.Check if reagent residual volume on the reagent information screen is lower
Reagent reagent bottle on R1 disk is less than the
31-1 Warning than its setup value.
shortage(R1) setup value of reagent residual volume in
2.Check if the setup value of reagent residual volume is reasonable.
system setup interface.
Reagent volume in R2 or R3 reagent bottle
1.Check if reagent residual volume on the reagent information screen is lower
Reagent on R2 disk is less than the setup value of
32-1 Warning than its setup value.
shortage(R2) reagent residual volume in system setup
2.Check if the setup value of reagent residual volume is reasonable..
interface.
Detergent The Detergent volume on No.45 position
33-1 Warning Call for the reagent information screen, check if detergent is enough.
low(R1) of R1 disk is less than 5ml.
Detergent The Detergent volume on No.45 position
34-1 Warning Call for the reagent information screen, check if detergent is enough.
low(R2) of R2 disk is less than 5ml.
1.Reagent name setup error, reagent
Reagent residual test time cannot be checked.
1.Check barcode stick information, scan the barcode again after check.
35-1 Warning information 2.reagent type setup error, reagent residual
2.register the reagent information manually.
setup error(R1) test time cannot be checked. 3.the item is
not set in analyze parameter.
1.Reagent name setup error, reagent
Reagent residual test time cannot be checked.
1.Check barcode stick information, scan the barcode again after check.
36-1 Warning information 2.reagent type setup error, reagent residual
2.register the reagent information manually.
setup error(R2) test time cannot be checked. 3.the item is
not set in analyze parameter.
ISE Reference The remaining volume of Reference Liquid
37-1 Warning Please check if ISE reagent volume is enough.
Liquid shortage is shortage.
1. Add ISE internal standard liquid.
ISE Internal
2. Call up system maintenance screen, carry out ISE internal standard liquid
38-1 Warning standard liquid Internal standard liquid shortage .
pipeline washing.
shortage
3. Carry out ISE calibration. .
256
ISE Diluent
39-1 Warning Diluent liquid shortage. Please check if ISE reagent volume is enough.
liquid shortage
Sampling Sample registered finished sampling, stop
41-1 Warning
finished to adding.
1.Call up the system maintenance screen, first carry out the program "reset",
Automatic Timing calibration is not carried out when
then go on "mechanism check".
51-1 Warning calibration reagent residual volume cannot complete
disable 10 tests.
department.
The mean electromotive force of internal
1.Carry out "ISE Check" on the Mechanisms Check screen.
standard solution (EAV) is out of the
ISE LEVEL 2.If it is not easy for the user to remove the cause of trouble, contact the service
60-1 Warning following range at 3 of 5 measuring
Error department.
points(internal standard
3.For details refer to "electrolyte device maintenance" in "User manual".
solution)Na:-90.0mvEAV-10mv
Error department.
solution)K:-90.0mvEAV-10mv
Error department.
solution)Cl:80.0mvEAV160mv
The difference between the maximum and
minimum electromotive forces of internal 1.Carry out "ISE Check" on the Mechanisms Check screen.
standard solution (FIV) is within the 2.If it is not easy for the user to remove the cause of trouble, contact the service
61-1 Warning ISE Noise Error
following range at 3 of 5 measuring department.
points.(internal standard solution, 3.For details refer to "electrolyte device maintenance" in "User manual".
sample)Na:0.7mv|FIV(2)-FIV(4)|
257

points.(internal standard solution, 3.For details refer to "electrolyte device maintenance" in "User manual".
sample)K:1.0mv|FIV(2)-FIV(4)|
points.(internal standard solution, sample) 3.For details refer to "electrolyte device maintenance" in "User manual".
Cl:0.8mv|FIV(2)-FIV(4)|
1.Upon calibration, the slope level is within
the following range. 1.Carry out "ISE Check" on the Mechanisms Check screen.
ISE Prepare 2.The electrode response is degraded (the 2.If it is not easy for the user to remove the cause of trouble, contact the service
62-1 Warning
Error carryover rate A is as follows) department.
Na:(1)32.0mvSLOPE37.0mv or 3.For details refer to "electrolyte device maintenance" in "User manual".
8.1mvSLOPE
ISE Prepare 2.The electrode response is degraded (the 2.If it is not easy for the user to remove the cause of trouble, contact the service
62-2 Warning
Error carryover rate A is as follows) department.
K:(1)32.0mvSLOPE37.0mv or 3.For details refer to "electrolyte device maintenance" in "User manual".
68.1mvSLOPE
the following range.
2.The electrode response is degraded (the
62-3 Warning ISE Slope Error 2.If it is not a single malfunction, contact the service department.
carryover rate A is as follows)
Cl:(1)-30.0mvSLOPE-25.0mv or
-68.1mvSLOPE
258

63-1 Warning ISE Slope Error 2.The electrode response is degraded (the 2.If it is not a single malfunction, contact the service department.
carryover rate A is as follows) 3.For details refer to "electrolyte device maintenance" in "User manual".
Na:(1)SLOPE < 32.0mv
K:(1)SLOPE < 32.0mv
Cl:(1)SLOPE > -25.0mv
The concentration of internal standard
ISE 1.Carry out "ISE Check" on the Mechanisms Check screen.
solution C(IS)is within the following
64-1 Warning concentration 2.If it is not a single malfunction, contact the service department.
range: Na:C(IS)< 120.0mmol/l or
error 3.For details refer to "electrolyte device maintenance" in "User manual".
160.0mmol/< C(IS)
range: K:C(IS)< 3.0mmol/l or 7.0mmol/<
error 3.For details refer to "electrolyte device maintenance" in "user manual".
C(IS)
range: Cl:C(IS)< 80.0mmol/l or
error 3.For details refer to "electrolyte device maintenance" in "user manual".
120.0mmol/< C(IS)
ISE require Carry out ISE calibration after ISE
65-1 Warning Carry out ISE calibration.
calibration maintenance(ISE rinsing,rinsing all)
259
Time sync
143-1 Stop Time sync instruction transmitting failure. 2.Various malfunctions or trouble can not be restored . Contact the service
failure
department.
1.Check the supplying pipe whether air exists in.check the height of water tank
whether it is more than 1.5 meters (distance from ground)if it will be used.
Add water Water tank liquid path system error, add
143-2 Warning 2.Check if water supplier, pipeline and filter is normal.
overtime water overtime.
department.
AD board reset Error occurs when AD board reset, AD
143-3 Warning 2.Various malfunctions or trouble can not be restored. Contact the service
failure board reset failure.
department.
1.Check if there is waterdrop on the code wheel.
Reaction disk Error occurs when reaction disk resetting 2.Call up the system maintenance menu and carry out the check program "reset".
143-4 Warning
reset failure and reaction reset failure. 3.Various malfunctions or trouble can not be restored. Contact the service
department.
1.Check if there is substance in sample container.
Sample disk Error occurs when sample disk resetting
reset failure and sample disk reset failure.
department.
1.Check if there is substance in reagent R1 container.
R1 disk reset Error occurs when R1 disk resetting and
failure R1 disk reset failure.
department.
1.Check if there is substance in reagent R2 container.
R2 disk reset Error occurs when R2 disk resetting and
failure R2 disk reset failure.
department.
1.Check if incubation filter and diluent waste pipeline is clog.
Water discharge
143-8 Warning Incubation bath discharge failure. 2.Various malfunctions or trouble can not be restored. Contact the service
failure
department.
Adding Detergent is not added completely in 1.Call up the system maintenance menu and carry out the check program "reset".
143-9 Warning detergent specified time by reagent probe 1 and 2.Various malfunctions or trouble can not be restored. Contact the service
overtime reagent 2. department.
260
R1 liquid level R1 probe cannot detect the liquid level
detect failure when adding detergent.
department.
R2 liquid level R2 probe cannot detect the liquid level
detect failure when adding detergent.
department.
1.Check if liquid level sensor of incubation bath is clean and if there are water in
Incubation bath incubation bath
143-12 Warning liquid level Incubation bath liquid level detect failure. 2.Restart the instrument.
detect failure. 3.Various malfunctions or trouble can not be restored. Contact the service
department.
1.Check if liquid level sensor of incubation bath is clean and if there are water in
incubation bath
Incubation bath
143-13 Warning Add water overtime in incubation bath. 2.Restart the instrument.
liquid path error
department.
Barcode 1.Call up the system maintenance menu and carry out the check program "reset".
143-14 Warning scanning Barcode scanning overtime. 2.Various malfunctions or trouble can not be restored. Contact the service
overtime. department.
143-15 Warning Degas overtime Degas overtime 2.Various malfunctions or trouble can not be restored. Contact the service
department.
Reaction
143-16 Stop Reaction initialize failure 2.Various malfunctions or trouble can not be restored. Contact the service
initialize failure
department.
Reaction disk
143-17 Stop Reaction disk stop failure 2.Various malfunctions or trouble can not be restored. Contact the service
stop failure
department.
Sample probe
143-18 S .Stop Sample probe is block To remove the block please according to 12.4.1 in "user manual".
block
261
Add sample After testing upon added sample, call up system maintenance menu, carry out
143-19 S .Stop Last add sample failure
failure "reset".
After testing upon added sample, call up system maintenance menu, carry out
143-20 S .Stop Add R1 failure Last add R1 failure.
"reset"
143-21 S .Stop Add R2 failure Last add R2 failure
"reset"
"reset"
R1 stirring After testing upon added sample, call up system maintenance menu, carry out
143-24 S .Stop Last R1 stirrer failure
failure "reset"
failure "reset"
failure "reset"
failure "reset"
143-28 Warning Waste bottle full The waste bottle is full Empty the waste bottle.
Error on float switch, high liquid level float

1.Call up the system maintenance menu and carry out the check program "reset ".
Float switch switch could detect the signal but the low
error liquid level float switch cannot. is not
department.
detect the signal.
Reagent
horizontal
143-30 Warning Reagent horizontal scanning overtime. 2.Various malfunctions or trouble can not be restored. Contact the service
scanning
department.
overtime.
262
Vacuum pump
143-31 Warning Vacuum pump negative pressure too low. Please contact the maintenance department.
error
Barcode
143-32 Warning scanning Barcode scanning overtime when testing.
"reset".
overtime.
ISE resetting Error occur in ISE resetting process, and
failure the resetting do not accomplish.
department.
ISE check 1.Call up the system maintenance menu and carry out the check program "reset ".
143-34 Warning operation ISE check operation overtime. 2.Various malfunctions or trouble can not be restored. Contact the service
overtime department.
ISE pipeline
143-35 Warning ISE pipeline rinsing overtime. 2.Various malfunctions or trouble can not be restored. Contact the service
rinsing overtime
department.
Error occur when ISE testing, ISE testing
143-36 Warning ISE testing error 2.Various malfunctions or trouble can not be restored. Contact the service
stop.
department.
Gear wheel
143-37 Stop Gear wheel pump pressure too low. Please contact the maintenance department.
pump error
R1 disk cover
143-38 Warning R1 disk cover is open.
open
R1 disk cover is close, instrument will
R1 disk cover
143-39 Warning automatically carry out reagent horizontal
close
scanning.
R2 disk cover
143-40 Warning R2 disk cover is open.
open.
R2 disk cover is close, instrument will
R2 disk cover
143-41 Warning automatically carry out reagent horizontal
close.
scanning.
263
Mapping 1.Call up the system maintenance menu and carry out the check program "reset".
Transmit reagent mapping information
143-42 Stop information 2.Various malfunctions or trouble can not be restored. Contact the service
failure and add reagent may failure too.
transmit failure department
When water tank temperature exceed 36.5
Cooling degree, infuse cold water into water tack, 1.Room temperature is too high or water supply equipment error occur.
143-43 Warning
overtime and water tank temperature cannot reduce 2.Please contact the maintenance department.
to 35.5 degree in 1 minute.
1.Pwer off and restart the instrument.
Instrument
143-44 Stop Error occurs between instrument modules. 2.Various malfunctions or trouble cannot be restored. Contact the service
module error
department.
Continue Carry out cell blank test to judge cup states. If cell blank value is abnormal,
143-45 Stop contaminated Continually 5 contaminated cup occur. please change reaction cuvette cup, if cell blank value is normal please contact
cup occur maintenance department.
In resetting, if trouble cannot remove, or other malfunctions exist, please contact
143-46 Stop AD data error AD data error
maintenance department.
In resetting, if trouble cannot remove, or other malfunctions exist, please contact
143-47 Warning Test ISE error ISE test internal standard liquid failure
maintenance staff.
Read edition 1.Call up the system maintenance menu and carry out the check program "reset".
143-48 Warning number Read edition number overtime 2.Various malfunctions or trouble can not be restored. Contact the service
overtime department.
143-49 Warning Illegal test item Illegal test number and reagent volume Please contact the service department.
1.Check if reagent disk lid is covered. Check if environment temperature is

Cooling system confirm to instrument requirement.
144-1 Warning Cooling time abnormal
abnormal 2.If trouble cannot be removed,or other malfunction exist, please contact the
maintenance department.
Cooling system
144-2 Warning Cooling circuit abnormal Please contact the maintenance department.
abnormal
Cooling system
144-3 Warning Cooling chip abnormal Please contact the maintenance department.
abnormal
264
Cooling system Please add water in cooling system water take according to 12.4.8 in the "user
144-4 Warning Cooling liquid level abnormal
abnormal manual".
Cooling system
144-5 Warning Cooling status abnormal Please contact the maintenance department.
abnormal
Ambience
Ambience temperature is over 15-32
144-6 Warning temperature Please contact the service department.
degree.
over
Cooling status
(1). Cooling system is not connected.
144-7 Warning cannot be Please contact maintenance staff.
(2). Cooling system malfunction.
confirmed.
Cooling fan
144-8 Warning Cooling fan running abnormal. Please contact maintenance staff.
malfunction
Path 1 cooling
145-1 Warning Path 1 cooling circuit is less than 5A Please contact the maintenance department.
chip error
Path 2 cooling
chip error
Path 3 cooling
chip error
Path 4 cooling
chip error
Path 5 cooling
chip error
Path 6 cooling
chip error
Path 1 AD Path 1 AD collector value has exceed
146-1 Warning Please contact the maintenance department.
collector error normal range.
Path 2 AD Path 2 AD collector test value has exceed
265

Note: Alarm code is composed of big sort and small sort.

Small sort
Big sort
266
Chapter 14 Risk Evaluation

In order to avoid any hazard when operator is in equipment use, maintenance, control risks related to instrument
use, and reduce these risks to acceptable level. At the beginning of the design, the instrument has taken
corresponding measures. Hazards and measures taken in the use process are as follows:
Risk Evaluation
Potential Risk Level Risk Reduction
Formative factor S O Before After
risks Measure
measure measure
1. Component between
instrument and flood
electricity pass safety
certificate.
2. Components between
Power supply with switch is
strong electrical
adopted to input AC, so in the
connections are locked
instrument, danger voltage
by heat-shrinkable tube
Electricity exist. S4 P6 N/ACC ACC
and sealed by silicone.
If touch the parts with danger
3. Design of the
voltage, user may get an
instrument ensures that
electric shock.
the users cant touch
danger voltage parts
when they unarmed
disassembling the
instrument.
Label the
biohazardsymbol at
spot where the reagent,
sample and waste liquid
Bio-contamina The tested waste liquid may flows out of the
S4 P4 N/ACC ALARP
tion contain bio-contamination instrument. Emphasize
that user should wear
glove during dealing
waste according to Lab
rules in the manual.
267
Label the
biohazardsymbol at
spot where the reagent,
Re-and/or During maintenance and sample and waste liquid
cross- disposal cast-off, the waste flows out of the
S4 P3 ALARP ACC
contamination urine may bring operator instrument. Emphasize
cross- contamination. that user should wear
glove during dealing
waste according to Lab
rules in the manual.
Add filters in power
Susceptibility Strong electromagnetic supply part and other
to interference may lead parts that have the
S2 P2 ALARP ACC
electromagneti instrument to dead or mistake tendency to be
c interference in running. interfered to enhance
anti-jamming ability.
During circuit design,
magnetic components
Electromagnetic signals are added to
Emissions of emitted by the analyzer radicalization circuitry
electromagneti interfere other instrument S2 P2 ALARP ACC in order to restrain
c interference through electrical wire radiation. And good
radiation or circumjacent specific EMI having 4
layers of circuit boards
is adopted.
Contamination
due to waste
Emphasize how to deal
products Waste liquid has potential
S2 P2 ALARP ACC with the waste strips in
and/or medical contamination.
the instruction.
device
disposal
It may cause the instrument Attach label on the

not run normally that there no appropriate position so
Inadequate
adequate labeling to indicate S2 P3 ALARP ACC that to remind user.
labeling
the operator how to use the The label is explained
instrument. in the manual in detail.
Explained how to
inadequate Leading to misoperation and
operate the instrument
specification abnormal running of S2 P2 ALARP ACC
in the Operation
of operation instrument.
Manual in detail.
268
inadequate
Explained how to
specification
operate the accessories
of accessories Incorrect results may occur by
S3 P3 ALARP ACC and consumable in the
to be used using wrong reagent model.
Operation Manual in
with the
detail.
medical device
Inadequate Illustrate how to check

Leading to misoperation and
specification the analyzer before use
abnormal running of S2 P2 ALARP ACC
of pre-use in Operation Manual in
instrument.
checks detail.
over-complicat Leading to misoperation and Operation Manual is

ed operating abnormal running of S2 P3 ALARP ACC concise and
instructions instrument. comprehensive.
Compile concise and

Inadequate
comprehensive
specification May lead to misoperation of
S3 P2 ALARP ACC operation manual so
of service and instrument
that user can master it
maintenance
soon.
Compile concise and

Used by comprehensive
May lead to misoperation of
unskilled/untra S2 P4 ALARP ACC operation manual so
instrument
ined personnel that user can master it
soon.
Incorrect
Carry out quality
measurement
control on the
and other May lead to incorrect results S3 P2 ALARP ACC
instrument by quality
metrological
controls
aspects
Incompatibilit
Specified reagent is required.
y with Indicate in consumables
Users should not replace them
consumables/a S2 P4 ALARP ACC and accessories in detail
by other Specified. Otherwise
ccessories/oth in the users manual.
test result will be incorrect
er devices
1. Lead to misoperation, at
the same time affect normal
Mistakes and Explain each operation
use.
judgment S2 P3 ALARP ACC interface in detail in the
2. The operator cannot
errors users manual.
understand test result
correctly.
269
Predigest operation and

describe the operation
Violation or
particular in the users
abbreviation The result may be error when
manual. The relevant
of users dont operate the
S1 P3 ALARP ACC prompts shall be
instructions , analyzer according to the
designed in the
procedures , users manual.
operation software, and
etc.
alarm can be issued
when failure occurs.
Add trap in the software

Complex or This may cause the to prevent the hazard
confusing instrument working S2 P3 ALARP ACC spreading and eliminate
control system abnormally the fault when restart
the instrument
That the massage displayed Display the working

Ambiguous or on the screen is not accord status of the instrument
unclear device with the actual status of the S2 P4 ALARP ACC on the screen and
state instrument may cause illustrate the status in
misopetation. the users manual.
Ambiguous or
unclear That the massage displayed Display the working
presentation of on the screen is not accord status of the instruments
settings , with the S2 P3 ALARP ACC on the screen and
measurements actual status of the instrument illustrate the status in
or other may cause misopetation. the users manual.
information
Lack of or
inadequate
specification
for
maintenance Elaborate about the
Cause instrument
including maintenance ways of
performance decline and S1 P4 ALARP ACC
inadequate the instrument in the
affect normal use.
specification users manual
of post
maintenance
functional
checks
Elaborate about the
Cause instrument
Inadequate maintenance ways of
performance decline and S2 P2 ALARP ACC
maintenance the instrument in the
affect normal use.
users manual
270
Elaborate all parts of

Loss of the instrument in the
This may cause the
electrical / operation manual, so
instrument working S4 P2 ALARP ACC
mechanical operator can check
abnormally.
integrity integrity of the
instrument.
Inadequate
Establish the packaging
packaging Inadequate packaging may
standard, List the
(contaminatio cause the instrument or its
S4 P2 ALARP ACC storage and
n and/or parts damage during
transportation condition
deterioration transportation.
in the operation manual
of the device)
Damage severity classification
Classification Criteria
S1 Negligible Little or no possibility of potential hazard
S2 Marginal Lead to mild contamination
Lead to danger and severe infection of life or

S3 Critical
serious injury
S4 Fatal Lead to life-threatening injuries
Hazard probability classification
Classification Frequency/Year/Unit
P1 Frequent >1
P2 Probable 1-10-1
P3 Occasional 10-1-10-2
P4 Remote 10-2-10-4
P5 Unlikely 10-4-10-6
P6 Incredible <10-6
271
Risk assessment standards
Severity
Probability of
Occurrence
S1 S2 S3 S4
Frequent ALARP N/ACC N/ACC N/ACC
Probable ALARP ALARP N/ACC N/ACC
Occasional ALARP ALARP ALARP N/ACC
Remote ACC ALARP ALARP ALARP
Unlikely ACC ACC ALARP ALARP
Incredible ACC ACC ACC ACC
N/ACCNot acceptable. ACCAcceptable. ALARPAs low as reasonable practical
All the risks, remaining after measures, on one hand, are not allowed at N/ACC level, on the other
hand, are allowed at ALARP level with less than n ones.
272
Chapter 15 Instrument Transportation and Storage
15.1 Transportation requirement
Waterproof and moisture proof is required while transportation. Do not extrude or vibrate the instrument.
Handle it gently while carrying and loading.
15.2 Storage requirement
Instrument should be stored in clean room with no chemical, no aggressive gas.
15.3 Storage environment
Instrument should be stored in clean room with no chemical, no corrosive gas. Height above sea level within
2000 meter, temperature within -1040, relative humidity within: 40 85 atmospheric
pressure within: 76kPa106kPa.
273
Addendum A Product Warranty
Dear customer:
Thank you for purchasing SAPPHIRE 800 Auto-Chemistry Analyzer of our company. We can offer you the
following service:
1. Technique consultation is provided at any time.
2. One year warranty from the day purchased. If instrument malfunction is caused by design defect,
manufacture defect, our company will repair them without payment.
3. Paid service is provided in following condition:
(a) Product out of warranty period.
(b) Damage caused by accident or wrong operation.
(c) Operation is not according to the manual requirement.
(d) Repair the instrument without our permission.
4.Upgrading service is provided along with the technique improvement.
For technique support, contact the following address and telephone:
Manufacturer: Audit Diagnostics
Address: Business & Technology Park, Carrigtwohill, Co. Cork, Ireland

Tel: 353 21 4533652; Fax: 353 21 4533653
E-mail: info@auditdiagnostics.ie
Website: http://www.auditdiagnostics.ie
274
Addendum B Product Description
B.1 Product assortment
According to medical equipment product assortment catalogue:
Belong to biochemical analyze system in clinic test analyze instrument (6840), type II in management type.
According to electric shock protection assortment: I type
B.2 Accessory reagent
Following table explains the accessory reagent (often used biochemical reagent parameter table).
275
276
Measurable
wavelength Reagent volume
(nm) Samp Deviat
Photo Sensit Blank
Item Assay le Calibration Calibrati Span Reaction ion Discrete
Time metric ivity horizont
name mode Main Sub volum method on point point direction rate check
point check al check
wavel wavel e R1 R2 R3 R4 check
ength ength
Rate 2-point
ALT 10 340 405 21-31 30 240 0 60 0 2 2 Negative 3.3 0.05 0 0.8-2.5
A linearity
Rate 2-point
AST 10 340 405 21-31 30 240 0 60 0 2 2 Negative 3.3 0.05 0 0.8-2.5
A linearity
Rate 2-point
ALP 10 405 505 21-26 4 200 0 50 0 2 2 Positive 3.3 0.05 0 0-1.0
A linearity
Rate 2-point
GGT 10 405 505 21-31 25 200 0 50 0 2 2 Positive 3.3 0.05 0 0-1.2
A linearity
2point 2-point
TBA 10 405 505 20-26 4 270 0 90 0 2 2 Positive 3.3 0.05 0 0-1.2
rate linearity
1point 2-point
TBIL 10 546 660 31 20 0 0 200 0 2 2 Positive 3.3 0.05 0 0-0.5
assay linearity
1
2-point
DBIL point 10 546 660 31 20 0 0 200 0 2 2 Positive 3.3 0.05 0 -0.1-0.5
linearity
assay
1
2-point
TP point 10 546 700 31 5 250 0 0 0 2 2 Positive 3.3 0.05 0 -0.5-0.5
linearity
assay
1
2-point
ALB point 5 600 700 10 2 300 0 0 0 2 2 Positive 3.3 0.05 0 0-0.5
linearity
assay
Rate 2-point
LAP 10 405 505 21-31 15 240 0 60 0 2 2 Positive 3.3 0.05 0 0-1.2
A linearity
Rate 2-point
SCHE 10 405 505 20-26 3 240 0 60 0 2 2 Positive 3.3 0.05 0 0-1.0
A linearity
Rate 2-point
ICDH 10 340 405 21-31 15 240 0 60 0 2 2 Positive 3.3 0.05 0 -0.1-1.0
A linearity
277
Measurable
(nm) Samp Deviat
Photo Sensit Blank
ength ength
Rate 2-point
GLDH 10 340 405 21-31 15 240 0 60 0 2 2 Negative 3.3 0.05 0 0.5-2.5
A linearity
Rate 2-point
AMY 10 405 505 21-26 5 160 0 40 0 2 2 Positive 3.3 0.05 0 -0.1-1.2
A linearity
2point 2-point
BUN 10 340 405 20-26 3 240 0 60 0 2 2 Negative 3.3 0.05 0 0.8-2.5
Rate linearity
CRE- 2point 2-point
10 546 700 16-31 8 240 0 60 0 2 2 Positive 3.3 0.05 0 -0.1-0.8
E Rate linearity
2point 2-point
CRE 10 505 660 18-23 20 150 0 150 0 2 2 Positive 3.3 0.05 0 0-1.2
rate linearity
2point 2-point
GLU 15 505 660 16-49 2 240 0 60 0 2 2 Positive 3.3 0.05 0 0-0.8
assay linearity
GLU 2point 2-point
10 340 405 15-31 2 240 0 60 0 2 2 Positive 3.3 0.05 0 -0.1-1.0
(HK) assay linearity
2point 2-point
FMN 10 546 700 16-31 15 300 0 0 0 2 2 Positive 3.3 0.05 0 -0.1-0.8
rate linearity
2point 2-point
TC 10 505 660 16-31 3 240 0 60 0 2 2 Positive 3.3 0.05 0 -0.1-0.5
assay linearity
2point 2-point
TG 10 546 700 16-31 3 240 0 60 0 2 2 Positive 3.3 0.05 0 -0.1-0.5
assay linearity
HDL- 2point 2-point
10 546 660 16-31 3 225 0 75 0 2 2 Positive 3.3 0.05 0 0-0.8
C assay linearity
2point 2-point
LDL-C 10 546 660 16-31 4 300 0 100 0 2 2 Positive 3.3 0.05 0 -0.1-0.8
assay linearity
278
Measurable
(nm) Samp Deviat
Photo Sensit Blank
ength ength
CK-M Rate 2-point

10 340 405 25-31 10 200 0 50 0 2 2 Positive 3.3 0.05 0 -0.1-1.2
B A linearity
Rate 2-point
CK 10 340 405 25-31 5 200 0 50 0 2 2 Positive 3.3 0.05 0 -0.1-1.2
A linearity
Rate 2-point
HBDH 10 340 405 21-31 6 240 0 60 0 2 2 Negative 3.3 0.05 0 0.8-2.5
A linearity
Rate 2-point
LDH 10 340 405 21-31 5 240 0 60 0 2 2 Positive 3.3 0.05 0 -0.1-1.0
A linearity
2point
2-point
UA rate 10 546 700 16-31 4 200 0 50 0 2 2 Positive 3.3 0.05 0 -0.1-0.8
linearity
assay
1point 2-point
P 5 340 405 10 4 200 0 0 0 2 2 Positive 3.3 0.05 0 -0.1-0.8
assay linearity
Ca- 2point 2-point
10 570 660 15-31 6 150 0 150 0 2 2 Positive 3.3 0.05 0 -0.1-0.5
CPC assay linearity
1point 2-point
Cl 5 505 660 15 3 300 0 0 0 2 2 Positive 3.3 0.05 0 -0.1-0.5
assay linearity
Ca- 1point 2-point
5 660 750 15 3 300 0 0 0 2 2 Positive 3.3 0.05 0 0-0.8
ARS assay linearity
1point 2-point
Mg 4 546 750 10 3 300 0 0 0 2 2 Positive 3.3 0.05 0 0-1.2
assay linearity
Note: For specific parameter, please refer to reagent instruction. In order to add items, please set according to the parameters of reagent instruction. To calculate sample
result, calibration by calibration serum with the practical factor is advised if the items are tested by rate A assay.
279
Statement
Audit Diagnostics has the final power of interpretation.
Audit Diagnostics is responsible for the security, reliability and capability of SAPPHIRE 800
auto-Chemistry analyzer under following circumstance.
1) Installation, adjustment, improvement and repair are proceeded by Audit Diagnostics company
professionals.
2) Relevant electric equipments are qualified according to state norms.
3) User Manual should be obeyed when operating instrument.
No extra announcement if interface changed.
Any questions, please call
Business & Technology Park,

Carrigtwohill, Co. Cork, Ireland
Tel: 353 21 4533652; Fax: 353 21 4533653
280

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User Manual of SAPPHIRE 800 Auto-Chemistry Analyzer

9.4 Cross contamination ..................................................................................................................................166

Chapter 1 Brief Introduction

1.2 Main technical index

Instrument structure: Discrete system

Simultaneous analysis item No.: At most 88 colorimetric items,

3 ISE items (K, Na, Cl).

Sample volume: 2 to 35l (Stepping 0.1l)

Reagent volume: 20 to 350l (Stepping 1l)

Reaction solution volume: 150450l

Stirring: Independent stirring after reagent injecting.

Reagent disk: Dual disk

Disk 1: 45 positions for Reagent 1, Reagent 4, diluents and CS anti-bacterial

Disk 2: 45 positions for Reagent 2, Reagent 3, CS anti-bacterial phosphor-free

Photometer: Grating spectrophotometry system in a range of 340750nm, wavelength: 340,

Wave length accuracy: 2nm

Measurement range: 0 to 3.3Abs

Reaction cuvette optical diameter: 6mm

Reaction cuvette rinse: Automatic

Incubation bath temperature: 370.1

Reaction time: 15 minutes at most (optional for 3, 4, 5, 10 and 15 minutes)

Analysis method: Rate assay, end-point assay, 2-point assay.

Reagent bottle volume: 20ml, 70ml

Reagent cooling unit: All reagents keep at 5 - 15, semiconductor refrigeration.

Power supply: ~220/230V 50Hz

Ambient temperature: 1532 Optimum temperature: 18 to 25

Relative humidity: 40% 85%

Appearance dimension: 10607901150mm (lengthwidthheight)

Fixing power: 2000VA

Weight: About 300Kg

1.3 Composition of instrument

1.3.1 Appearance of instrument

Model symbol Cover Left front door Right front door

Figure 1-1 Front of instrument

1.3.1.2 Front of opening door

CS-Alkaline detergent port Sample syringe R2 syringe R1 syringe

1.3.1.3 Rear of instrument

Port of concentrated waste level sensor

Figure 1-3 Rear of instrument

1.3.1.4 Top of instrument

Sample pipetting mechanism Cuvette rinsing mechanism Reaction disk

R1 stirring mechanism R1 reagent pipetting mechanism R1 reagent disk

R2 reagent pipetting mechanism 11 R2 stirring mechanism 12 R2 reagent disk

Figure 1-4 Top of instrument

1.3.1.5 Right of instrument

Figure 1-5 Right of instrument

1.3.2 System configuration

Figure 1-6 System configuration

1.4 Configuration and function

1.4.1 Operating system

Host computer: Windows XP system

Special applied software and database.

Computer configuration: Basic frequency2.8GHz.

Hard disk160G Memory1G

With RS-232 serial interface, website interface and USB interface.

Keyboard: Operation control and data input.

Mouse: Carry out software operation.

Printer: Print out test data and chart.

1.4.2 Analytical system

1.4.2.1 Sample disk

Handgrip of sample disk outer track Sample barcode reader

Figure 1-7 Sample disk

(1) Composition and function

(2) Specifications (Sample No.)