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DIESTRO 103 AP v4
Auto Basic
V 4.00
Rev. 9, February 2015
RE 0809
DIESTRO 103 AP ELECTROLYTE ANALYZER
CONTENTS
1 - INTRODUCTION .......................................................................................................................................................... 7
2 - SAFETY INSTRUCTIONS ........................................................................................................................................... 8
1. IMPORTANT SAFETY INSTRUCTIONS................................................................................................................ 8
2. SYMBOLS.......................................................................................................................................................... 9
3 - INSTALLATION ......................................................................................................................................................... 11
1. UNPACKING ................................................................................................................................................... 11
2. INSTALLATION REQUIREMENTS .................................................................................................................... 11
3. CONNECTION ................................................................................................................................................. 12
TOUCHSCREEN CALIBRATION ........................................................................................................... 19
4. RETRACTABLE FILL PORT ............................................................................................................................. 19
4.1 Capillary Adapter ..................................................................................................................... 20
4 – CALIBRATING SOLUTION PACK (PACK) .......................................................................................................... 22
1. PACK .............................................................................................................................................................. 22
TWO TYPES AND IDENTIFICATION OF PACKS ...................................................................................... 22
2. PACK OF CALIBRATING SOLUTIONS MICROCHIP (UCHIP) ......................................................................... 23
3. CALIBRATING SOLUTIONS PACK VALIDITY ................................................................................................. 23
4. CALIBRATING SOLUTIONS CONSUMPTION ................................................................................................... 24
5. PACK´S PERFORMANCE ................................................................................................................................. 24
6. REPLACEMENT OF THE PACK ....................................................................................................................... 25
5 - SERUM/PLASMA/WHOLE BLOOD MEASURING .............................................................................................. 28
1. GENERAL COMMENTS ................................................................................................................................... 28
2. SAMPLE FILLING ............................................................................................................................................ 28
3. MEASURING ................................................................................................................................................... 29
4. PRINTED ELECTROLYTE REPORT .................................................................................................................. 32
5. SAMPLE DATA ENTER (OPTIONAL) ............................................................................................................... 32
6 – URINE MEASUREMENT .......................................................................................................................................... 34
1. GENERAL COMMENTS ................................................................................................................................... 34
2. SAMPLE FILLING ........................................................................................................................................... 34
3. MEASURING ................................................................................................................................................... 34
4. PRINTED ELECTROLYTE REPORT................................................................................................................. 37
5. SAMPLE DATA ENTER (OPTIONAL) .............................................................................................................. 36
7 - CALIBRATION ........................................................................................................................................................... 39
1. GENERAL COMMENTS ................................................................................................................................... 39
2. ONE POINT CALIBRATION............................................................................................................................. 39
3. TWO POINT CALIBRATION ............................................................................................................................ 39
3.1 Automatic Calibration .............................................................................................................. 39
3.2 On Demand Calibration ........................................................................................................... 39
4. CALIBRATION RESULT .................................................................................................................................. 40
5. PRINTED CALIBRATION REPORT ....................................................................................................... 42
6. SAVED RESULTS ....................................................................................................................................... 42
7. CALIBRATION OPTIONS ........................................................................................................................ 43
7.1 Electrolyte Enabling/Disabling ................................................................................................ 44
7.2 Units Modification .................................................................................................................... 45
7.3 Delta Correction Setting ........................................................................................................... 46
7.4 Delta Correction Rates ............................................................................................................. 48
8. ELECTRODES HISTORY .................................................................................................................................. 40
8.1 General Comments .................................................................................................................... 48
9. INSTALLED PACK HISTORY ........................................................................................................................... 50
9.1 General Comments .................................................................................................................... 50
10. STANDBY FUNCTION .................................................................................................................................... 52
8 – RINSE AND CLEANING ........................................................................................................................................... 53
1. GENERAL COMMENTS ................................................................................................................................... 53
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
2. AUTOMATIC RINSE......................................................................................................................................... 53
3. ON DEMAND RINSE ........................................................................................................................................ 53
4. AUTOMATIC CLEAN ....................................................................................................................................... 54
5. ON DEMAND CLEAN ....................................................................................................................................... 55
6. SODIUM CONDITIONER .................................................................................................................................. 56
7. CLEAN OF CAPILLARY FOR SAMPLING ........................................................................................................ 57
9 - PURGE ........................................................................................................................................................................... 60
1. GENERAL COMMENTS.................................................................................................................................... 58
2. AUTOMATIC PURGE ....................................................................................................................................... 58
3. ON DEMAND PURGE ....................................................................................................................................... 58
10 – QUALITY CONTROL .............................................................................................................................................. 62
1. GENERAL COMMENTS.................................................................................................................................... 62
2. QUALITY CONTROL PROCEDURE .................................................................................................................. 62
3. QUALITY CONTROL RESULTS ....................................................................................................................... 63
4. DELTA CORRECTIONS .................................................................................................................................... 65
5. DEFINITIONS ................................................................................................................................................... 65
11 - CLOCK ........................................................................................................................................................................ 67
1. DEFINITION..................................................................................................................................................... 67
2. CLOCK ADJUSTMENT ..................................................................................................................................... 67
12 – RESULT STORAGE .................................................................................................................................................. 69
1. GENERAL COMMENTS.................................................................................................................................... 69
2. MEASURMENT RESULTS ................................................................................................................................ 69
13 – NON DETECTED SAMPLES................................................................................................................................... 71
1. GENERAL COMMENTS.................................................................................................................................... 71
2. DISABLING THE SAMPLE SENSOR ................................................................................................................... 72
14 – CONFIGURATION OF PRINTER, SERIAL OUT, LANGUAGE AND LABORATORY´S DATA ............... 73
1. GENERAL COMMENTS.................................................................................................................................... 73
2. PRINTER, SERIAL OUT AND LANGUAGE CONFIGURATION ............................................................................ 74
15 - ERROR MESSAGES .................................................................................................................................................. 78
1. LIST OF ERRORS ............................................................................................................................................. 78
2. INTERNAL ERRORS 01 OR 02 .......................................................................................................................... 80
16 – MAINTENANCE........................................................................................................................................................ 83
1. DAILY MAINTENANCE.................................................................................................................................... 83
1.1 Analyzer´s Decontamination ............................................................................................................ 83
1.2 Clean ................................................................................................................................................. 84
2. WEEKLY MAINTENANCE ............................................................................................................................... 84
2.1 Sodium Conditioner ......................................................................................................................... 84
2.2 Internal Clean Of the Analyzer ........................................................................................................ 84
3. OTHER MAINTENANCE AND SPARE PARTS OR COMPONENT REPLACEMENT ................................................ 85
4. OPEN THE FRONT PANEL ................................................................................................................................ 85
5. CLOSE THE FRONT PANEL .............................................................................................................................. 85
6. INSTALLATION/REPLACEMENT OF THE DIESTRO FILL PORT CLEANER ..................................................... 86
7. TRANSPORTATION OF THE ANALYZER........................................................................................................... 87
7.1 Transportation within the laboratory............................................................................................... 87
7.2 If tranportation involves large movements, but it will be reinstalled within a day ......................... 87
7.3 If the analyzer will not be installed in more than two days ............................................................. 88
8. DISCARD OF CONSUMABLES ........................................................................................................................... 89
9. FINAL DISCARDING OF THE ANALYZER ......................................................................................................... 89
17 – SERVICE .................................................................................................................................................................... 90
1. GENERAL COMMENTS.................................................................................................................................... 90
2. ACCESS TO THE SERVICE MENU ..................................................................................................................... 90
3. REVISION AND ASSESSEMENT OF THE STATE OF ELECTRODES .................................................................... 91
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DIESTRO 103 AP ELECTROLYTE ANALYZER
QUADRATIC ECUATION CORRECTION FOR MEASURMENTS IN SERUM AND URINE. ....................................... 124
Entering Delta correction (Constant value) ............................................................................. 124
Entering quadratic and lineal values ........................................................................................ 125
RANGE OF NORMAL VALUES FOR SERUM AND URINE MEASUREMENTS.......................................................... 127
SCREEN MEASUREMENT TIME CONFIGURABKE AND OPTION TO REMOVE BEEPER. ...................................... 130
NA CLEAN REQUEST EVERY 7 DAYS. ............................................................................................................... 131
SERIAL OUTPUT FOR NET CONNECTIONS (LIS) ............................................................................................... 132
Serial output configuration: .................................................................................................................................. 133
Setting Baud rate, Flow control, Carriage return and Line Feed. ....................................................................... 133
Network delivery of results from memory.............................................................................................................. 133
Commands frm the Host to the Diestro ................................................................................................................. 133
Validation of the sample measurement before sending it to the memory or net .................................................. 133
ANNEX VI – QUALITY CONTROL CHART.............................................................................................................. 134
PARTS, REFERENCE CODES AND WARRANTY ................................................................................................... 135
WARRANTY .................................................................................................................................................. 136
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DIESTRO 103 AP ELECTROLYTE ANALYZER
LIST OF FIGURES
Fig. 1 Power supply and ground connection ................................................................................................... 13
Fig. 2 Pack's tray ............................................................................................................................................. 14
Fig. 3 Placing the Pack .................................................................................................................................... 14
Fig. 4 Connecting the Pack .............................................................................................................................. 14
Fig. 5 Pack ....................................................................................................................................................... 14
Fig. 6 Pack connection tubing kit ..................................................................................................................... 15
Fig. 7 Connected Pack .................................................................................................................................... 15
Fig. 8 Clamping button. .................................................................................................................................... 16
Fig. 9 Front opening - Step 1 ........................................................................................................................... 16
Fig. 10 Front opening - Step 2 ......................................................................................................................... 16
Fig. 11 Front opening - Step 3 ......................................................................................................................... 16
Fig. 12 Front opening - Step 4 ......................................................................................................................... 16
Fig. 13 Peristaltic pump ................................................................................................................................... 17
Fig. 14 Opening the Fill Port Cleaner - Step 1 ................................................................................................. 17
Fig. 15 Opening the Fill Port Cleaner - Step 2 ................................................................................................. 17
Fig. 16 Placing the Fill Port Cleaner - Step 1 .................................................................................................. 18
Fig. 17 Placing the Fill Port Cleaner - Step 2 .................................................................................................. 18
Fig. 18 The analyzer with the Fill Port in standby ............................................................................................ 20
Fig. 19 Fill Port in position for Tube ................................................................................................................. 20
Fig. 20 Fill Port in position for Capillary ........................................................................................................... 20
Fig. 21 Capillary adapter .................................................................................................................................. 21
Fig. 22 Taking sample with a capillary adapter ............................................................................................... 21
Fig. 23 ISE Calibrating Pack and its connection tubing kit .............................................................................. 22
Fig. 24 uChip.................................................................................................................................................... 24
Fig. 25 Closing the waste cap.......................................................................................................................... 26
Fig. 26 Installed Pack ...................................................................................................................................... 26
Fig. 27 Sample filling from a capillar ................................................................................................................ 28
Fig. 28 Sample filling from a tube .................................................................................................................... 28
Fig. 29 Printed electrolyte report...................................................................................................................... 32
Fig. 30 Printed urine report .............................................................................................................................. 37
Fig. 31 Printed calibration report...................................................................................................................... 42
Fig. 32 Drop ..................................................................................................................................................... 58
Fig. 33 Printed results of the quality control .................................................................................................... 65
Fig. 34 Example of laboratory's data in a ticket ............................................................................................... 76
Fig. 35 Front panel lock ................................................................................................................................... 85
Fig. 36 Fill Port Cleaner ................................................................................................................................... 86
Fig. 37 Analyzer connection diagram .............................................................................................................. 90
Fig. 38 Electrode train ...................................................................................................................................... 98
Fig. 39 Opening the electrode protector and taking out the electrode lock ..................................................... 99
Fig. 40 Taking out the defective electrode ....................................................................................................... 99
Fig. 41 Roll-holder opening............................................................................................................................ 103
Fig. 42 Paper roll replacement....................................................................................................................... 103
Fig. 43 Roll-holder closed .............................................................................................................................. 103
Fig. 44 Retractable Fill Port ........................................................................................................................... 105
Fig. 45 Fill Port ............................................................................................................................................... 106
Fig. 46 Pinch tube connection ....................................................................................................................... 106
Fig. 47 Front view .......................................................................................................................................... 109
Fig. 48 Side view ........................................................................................................................................... 109
Fig. 49 Front view with the front panel opened .............................................................................................. 110
Fig. 50 Rear view ........................................................................................................................................... 110
Fig. 51 Rear panel detail ................................................................................................................................ 111
Fig. 52 Electrode chamber............................................................................................................................. 111
Fig. 53 Example of patient ID in a ticket ........................................................................................................ 125
Fig. 54 Printed electrolyte report with values out of normal range ................................................................ 130
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
1 - INTRODUCTION
The Diestro analyzer is an IVD Medical Device manufactured with state-of-the-art
technology, accurate, reliable and designed to be simple in use as well as in maintenance.
Intended Use
The Diestro 103AP Electrolyte analyzer is an In Vitro Medical Device that allows the
measurement of electrolytes in whole blood, serum, plasma and urine samples.
It is capable to measure up to 5 electrolytes simultaneously: sodium, potassium,
chloride, calcium and lithium.
The health professionals utilize the obtained data for diagnosis purposes.
The contents of this manual and the hardware are protected under intellectual property laws and
international treaties. File No. 323588.
It is prohibited to reproduce all or part of this manual, the hardware or the menus of the Analyzer by any
means without the written permission of the owner of JS Medicina Electronica SRL.
The manufacturer reserves the right to modify the contents of the manual or equipment specifications
without notice.
The manufacturer is not liable for losses or damages directly or indirectly to users or third parties arising
from the use of this analyzer or the interpretation of the results.
JS Medicina Electrónica® manufacture under GMP standards according to the Regulations of ANMAT
(National Administration of Drugs, Food and Medical Technology of the Argentine Republic –
MERCOSUR-).
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DIESTRO 103 AP ELECTROLYTE ANALYZER
2 – SAFETY INSTRUCTIONS
1. IMPORTANT SAFETY INSTRUCTIONS
DANGER – Misuse of electrical equipment can cause electrocution, burns, FIRE
and other HAZARDS.
Basic safety precautions should always be taken, including all those listed below.
The user manual includes instructions and guidelines to observe during the start-up,
operation and maintenance of the Analyzer.
Therefore, the operator or any person that manipulate the analyzer Diestro 103AP
should read carefully the manual before start using it. This manual should always be near
of the Analyzer. The buyer of the analyzer is responsible to instruct and do read the
manual to each new operator.
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
2. Symbols
Several safety instructions are given in each chapter of the manual and on the analyzer to
highlight aspects relating to a safe operation.
Attention: Risk of DANGER. Before using read instructions in the user Manual or related
documentation
Biological RISK. There are parts of the Analyzer, accessories or consumables that may
cause biological damage. Be careful.
USE GLOVES WHENEVER you WORK WITH THE Analyzer,
THEIR PARTS AND SAMPLES ARE POTENTIALLY DANGEROUS.
Not discard the product as household waste. Failure to observe these instructions may have
harmful effects. The owner of the product has a responsibility to dispose of it in a location
designated for the recycling of electrical and electronic equipment. This action and subsequent
recycling of discarded material will contribute to the conservation of natural resources and
protecting the environment and its inhabitants. To determine what the correct location for the
recycling of discarded products, consult local authorities, with its collection of waste or recyclable material
services or the establishment in which you obtained the product.
Socket polarity
Ground connection
Temperature limits
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Warranty:
Quantity of months of
warranty
Fragile
-For more information about the analyzer press the Info button at anytime at any time.
Info button
Print
information
Go down
Select
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
3 - INSTALLATION
1. Unpacking
Carefully unpack and verify that the following items are inside the box:
. REF EQ 07XX Analyzer Diestro 103AP V4.
. REF IN 0100 ISE Calibrating Pack.
. REF IN 0305 Pack connection tubing kit.
. REF IN 0300 ISE Urine Diluent.
. REF IN 0400 ISE Cleaning Solution.
. REF IN 0600 Na+ conditioner.
. REF IN 0050 Fill Port Cleaner.
. REF IN 0750 Diestro Trilevel.
. REF IN 0700 Diestro Control.
. REF RE 0809 CD Manual.
. REF RE 0815 Quick Start guide.
. REF RE 0902 Power Supply 15V 2.5A.
. REF RE 0100 Peristaltic Pump tubing.
. REF RE 0200 Capillary for sampling.
. REF RE 0400 Capillary adapters.
. REF RE 1000 Ground wire.
. REF RE 1005 Pack’s Tray.
See section “Diagrams” to find parts and accessories of the Analyzer. Page 137
See section “Technical Specifications” to find detailed information. Page 141
2. Installation requirements
Power voltage and the power socket must comply with local electrical regulations.
There must be a connection to ground available to connect the ground wire of the
Analyzer. The voltage should be free of noise and fluctuations. If it is necessary install a
voltage stabilizer.
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Height: 270mm
Width: 164mm
Depth: 465mm
Weight: 5,4 Kg
The power socket for the equipment power supply must have easy access to the
connection and disconnection of the Analyzer in any condition.
See section “Power Supply specifications” to find detailed information. Page 141
3. Connection
Before installation see the section “Diagrams” Page 137 to identify the parts and
accessories for your Analyzer.
Use cables and provided accessories with your equipment. If necessary to replace one, use
spare parts provided or recommended by the manufacturer. Se section “Parts, reference
and codes” Page 83
3.1 Connect the ground wire to the Equipment ground terminal and then to the
ground connection. In the Laboratory that connection must be certificated by qualified
personnel. (Fig. 1)
3.2 Connect the power supply plug to the jack in the Analyzer. (Fig. 1)
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
uChip connection
USB connection
RS232 connection
Ground terminal
3.3 If the Analyzer is connected to a PC or external serial printer RS232, connect the cable
now. Use a Null-modem cable for the serial connection.
See section “Cables” to find detailed information. Page 108
3.4 Screw the Pack’s Tray to the back of the Analyzer. Use the provided Allen key.
3.5 Place the ISE Calibrating Pack on the Pack’s Tray. ( Fig. ).
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Clamping
screws
1) 2)
Fig. 2 Pack’s tray Fig. 3 Placing the Pack
3)
Fig. 4 Connecting the Pack
Fig. 5 Pack
3.6 Unscrew the caps, break the aluminum security seals and insert the special connection
caps from de Analyzer. Keep the caps to cover the bottles of the Pack at the moment of
discarding.
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
3.7 Connect the microchip adapter cable to the analyzer and the pack.
Be careful to match the color encoding and the texts on the Analyzer and Pack.
ISE Cleaning
solution
Caps
Analyzer couplings
Connected uChip
3.9 Open the front panel by making a quarter on the clamping button. Lean the front
panel forwards.
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Clamping
button
1) 2)
Fig. 9 Front opening - Step 1 Fig. 10 Front opening - Step 2
3) 4)
Fig. 11 Front opening - Step 3 Fig. 12 Front opening - Step 4
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
Remove one of the peristaltic tubing fittings and wrap around the peristaltic support pump
head with the pipe, to make contact with the roller head and insert the coupling in the free
support.
Bracket
See section “Peristaltic Pump Tubing replacement” to find detailed information. Page 104
3.11 Take the new Diestro Fill Port Cleaner, open the flask sealed and removed the
security seal.
Fig. 14 Opening Fill Port Cleaner - Step 1 Fig. 15 Opening Fill Port Cleaner - Step 2
3.12 Carefully lift the Fill Port capillary to take a horizontal position, present the Diestro
Fill Port Cleaner in front of the position guides and slide it gently until it stops against
the inner wall of the Diestro analyzer 103AP.
Make sure the Fill Port Cleaner is in the correct position, with the label "Front / Front"
facing the operator.
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Fig. 16 Placing Fill Port Cleaner - Step 1 Fig. 17 Placing Fill Port Cleaner - Step 2
See section “Installation / Replacement of the Diestro Fill Port Cleaner” Page 86
3.15 Verify the date and time of the Analyzer. It can be changed by the operator following
the steps detailed in the “Clock” section
If it’s needed to perform a touch screen calibration due to a bad functioning of it, follow the
next sequence:
-Wait a few seconds. Plug again the power source. Inmediately press the touch screen.
-The next screens will show up. You shall press with a finger or a not sharp plastic element
the points indicated by the arrows.
-Afterwards, the main menu will appear and the touch screen calibration will be over.
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Fig. 19 Fill Port in position for Tube Fig. 20 Fill Port in position for Capillary
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
Take major safety precautions regarding Bio safety. The samples, capillary and adapter are
potentially infectious. Handle with gloves.
Clean the Fill Port with a gauze wet in Cleaning Solution ISE REF IN 0400 after removing
the sample.
It is specially made for adapt the analyzer fill port to a capillary. It is easy to use:
4.1.1 In the Main Menu, move the handle to the Capillary position.
4.1.2 Connect to an extreme of the capillary.
4.1.3 Take the end of the fill port and connect the other extreme of the adapter to the
fill port and press fill.
4.1.4 When it is ready, remove the capillary and the adapter. Discharge them.
1) 2)
Fig. 21 Capillary adapter Fig. 22 Taking sample with a capillary adapter
Take major safety precautions regarding Bio safety. The samples, capillary and adapter are
potentially infectious. Handle with gloves.
Clean the Fill Port with a gauze wet in Cleaning Solution ISE REF IN 0400 after removing
the sample.
REF IN 0100
For the model without tubings (REF RE 0100) there is a Pack connection tubing Kit
(REF IN 0305), that consists of 3 caps, green, orange and red, with their corresponding
couplings and tubings to connect the analyzer to the pack. This kit is not for single use, it is
reused and remains connected to the analyzer. (It is a part of the Analyzer)
JS Medicina Electrónica recomends to replace simultaneously the Fill port Cleaner with the
ISE Calibrating Pack.
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
The type of Pack your Analyzer requires can be identified in the following screen of the
Analyzer: If the type of Pack is not the appropriate, the Analyzer shows an error message:
“Invalid Pack”.
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Fig. 24 uChip
The uChip provides the Analyzer information about volumes of the calibrating
Solutions, calibration values, batch number and date of expiry of the Pack.
The exhausted Pack contains potentially dangerous waste disposals, handle with gloves.
Do not open. See section “Discard of consumables” Page 87
Take care not to contaminate the caps, the green and orange tubings and their respective
socket, they will be used for the next Pack.
In the exhausted pack, put the green, orange and red caps that came with the Pack to their
5. Pack bottles before discarding to avoid losses.
Performance
The Pack performance depends on the way of use and maintenance of the Analyzer.
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
The Pack has been designed in such a way that the Pack solutions are always sufficient
for the doses calculated by the Analyzer under different amount of ions installed in the
Analyzer. In this manner, surplus solutions may remain in the Pack without being used
even if the “Exhausted PACK” message is shown.
It is recommended not to open the Pack.
The consumption of Standard A and Standard B will never be similar. Therefore, there will be
always proportional surplus of one more than the other.
The Analyzer will show the “Exhausted PACK” message when one of the solutions is
exhausted.
JS Medicina Electrónica recomends to replace simultaneously the Fill port Cleaner with the
ISE Calibrating Pack.
Take care to not contaminate green and orange caps and their respective tubing, they will
be used for the next pack In the exhausted Pack, put the green, orange and Red caps
which brought the Pack, to their respective flasks before discard it, to prevent leaks.
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DIESTRO 103 AP ELECTROLYTE ANALYZER
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
6.8 Reconnect the Power Supply to the Voltage Line. The analyzer turns on and
automatically performs Purge and Calibration.
+
See section “Calibration” y “Purge”. Pages 37 and 58 respectively.
Once the Calibrating process is over, the Analyzer display shows the following screen
and is ready to measure:
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Ensure the correct working of your Analyzer keeping it maintained and performing a Quality
Control. Refer to the “Maintenance” Page 83 and “Quality Control” Page 62 sections.
2. Sample Filling
Take major safety precautions regarding Bio safety. The samples, capillary and adapter are
potentially infectious. Handle with gloves.
Before measuring, clean well the fill port with cleaning solution ISE REF IN 0400 and then
rinse with distilled water.
The sample can be filled from a tube, syringe, or from a capillary (with an adapter).
When you fill from a Capillary, insert the capillary with the adapter into the needle. (Fig. )
From a tube or Syringe the filling is without adapter. (Fig. )
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
3. Measuring
- From the root menu, press Meas. (If the analyzer is on the principal screen skip the first
two steps)
In case 10 minutes have passed without use, the analyzer will need a Rinse befote
measurement.
- For samples from tube or syringe start measurement by moving the handle to its tube
position (45º). For samples from a capillary move the handle to its capillary position
(horizontal).
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Be careful with the Biological Risk. The samples, capillaries and adapters are potentially
infectious. Handle with gloves.
The Operator may fill the sample manually in case that is a non detected sample (a low
conductivity sample), pressing Sens. See section “Non detected samples” Page 71
If you have small amount of sample, the analyzer makes a beep to indicate that has
charge the minimum and necessary amount of sample to measure, from this warning
the user can remove the sample to reduce the amount that the equipment consumes
The Operator may enter information from the Sample by pressing Info. See section “Sample
Data enter” Page 32
- Once the filling is over, the Analyzer will give out a beep sound and will show the
following screen:
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
- The analyzer automatically positions the Sample in the Measuring Chamber and
performs its measurement.
- Subsequently, the Analyzer fills and places the Std. A for washing and one point
calibration.
If the analyzer can not fills with Std. A, it will show a Not filled error and the measurement is
not performed. See section “Error Messages” Page 77.
- When the measuring is complete, the Analyzer shows the results in the screen:
If the result of Sodium is lower than expected, perform a Sodium Conditioner Wash.
See section “Sodium Conditioner” Page 55.
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DIESTRO 103 AP ELECTROLYTE ANALYZER
Refer to the section “Reference Values” for further details about normal and critical ranks
suggested of the electrolytes in serum. Page 107
Refer to the section “Annex I – Clinical Significance of Serum/Plasma/Blood Electrolytes
Page 114
The Measuring Results is saved in memory and can be recovered as well as printed.
The analyzer can save the last 1000 measurements.
The user can enter sample information (Patient Nº) with the sequence:
- Pressing info you have access to the information screen about the sample to be
processed.
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DIESTRO 103 AP ANALIZADOR DE ELECTROLITOS
- The sample number is incremental and non editable. It is placed by the analyzer.
- Once the Patient Nº is entered, press “Esc” to continue the measuring sequence.
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DIESTRO 103 AP ELECTROLYTE ANALYZER
6 – URINE MEASUREMENT
1. General Comments
Ensure the correct working of your Analyzer keeping it maintained and performing a Quality
Control. Refer to the “Maintenance” Page 83 and “Quality Control” Page 62 sections.
2. Sample Filling
Take major safety precautions regarding Bio safety. The samples, capillary and adapter are
potentially infectious. Handle with gloves.
Before measuring, clean well the fill port with cleaning solution ISE REF IN 0400 and then
rinse with distilled water.
The Urine sample is always filled from a tube, always DILUTED with ISE Urine Diluent
REF IN 0300 provided with the Analyzer.
3. Measuring
- The measuring can be started from the principal screen pressing Urine:
- Press Esc and then move the handle to its Tube position.
In case 10 minutes have passed without use, the analyzer will need a Rinse before
measurement.
- Immerse the fill port in the sample and press fill. (Fig. 16)
Be careful with the Biological Risk. The samples, capillaries and adapters are potentially
infectious. Handle with gloves.
The Operator may fill the sample manually in case that is a non detected sample (a low
conductivity sample), pressing Sens. See section “Non detected samples” Page 69.
If you have small amount of sample, the analyzer makes a beep to indicate that has
charge the minimum and necessary amount of sample to measure, from this warning
the user can remove the sample to reduce the amount that the equipment consumes
The Operator may enter information from the Sample by pressing Info. See section “Sample
Data enter” Page 30.
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- Once the filling is over, the Analyzer will give out a beep sound and will show the
following screen:
Clean the Fill Port with a wet gauze in cleaning solution ISE REF IN 0400 after removing
the sample.
If you do not move the handle to its standby position the analyzer will not continue with the
measurement.
- The analyzer automatically positions the Sample in the Measuring Chamber and
performs its measurement.
- Subsequently, the Analyzer fills and places the Std A for washing and one point
calibration.
If the analyzer can not fills with Std. A, it will show a Not filled error and the measurement is
not be performed. See section “Error Messages”. Page 77.
- When the measuring is complete, the Analyzer shows the results in the screen
(“O” = Urine)
If the result of Sodium is lower than expected, perform a Sodium Conditioner Wash.
See section “Sodium Conditioner”. Page 55.
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See section “Reference Values” for further details about normal and critical ranks suggested
of the electrolytes in serum. Page 107
See section “Electrode Slope Range”. Page 113
The result is stored in the memory and can be recovered as well as printed. The
analyzer can store the last 1000 measures.
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- The sample number is incremental and non editable. It is placed by the analyzer.
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7 - CALIBRATION
1. General Comments
Ensure the correct working of your Analyzer keeping it maintained and performing a Quality
Control. Refer to “Quality Control” Page 62 and “Maintenance” Page 83.
3. Two-point Calibration
3.2.1 It can be performed on the Operator’s demand through the sequence starting
from the principal screen pressing menu:
In case 10 minutes have passed without use, the analyzer will need a Rinse. It is
recommended make it before the calibration, but it is not necessary.
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When the two-point calibration starts, the Analyzer fills and stabilizes twice for each
calibration solution automatically. Start with Std B then continues with Std. A.
If the analyzer can not fills with any of both Std. it will show a Not Filled error and the
Calibration is aborted.
4. Calibration Result
4.1 When the Calibration process is complete, the analyzer reports the results through the
screen, showing each electrode with its slopes and status:
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4.2 Pressing the “Ca.” key, you have 4.3 Pressing the “Na..” key, you can
access to the remaining electrodes. see again the three first electrodes.
The “Calibrated” caption indicates that the electrode is ready for measuring.
See section "Technical Specifications" Page 135 to see the allowed Gain Ranges.
If the result of Sodium is lower or higher than expected, perform a Sodium Conditioner
Wash. See section “Sodium Contitioner”. Page 55.
4.4 In case one of the electrodes did not calibrate, the analyzer will show it in the report.
The “Not CALIB” caption indicates that the electrode is not ready for measuring. In this case
the electrolyte will not be measured.
Refer to section “Error Messages” Page 77.
The results of the last Calibration are saved in the memory analyzer and can be seen by
the user at any time
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6. Saved results
6.1 The results of the last calibration can be seen by the operator with the following
sequence, starting in the principal screen:
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7. Calibration Options
All the calibration option starts in the calibration menu.
- To access this menu, in the principal screen press menu
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Disabling an electrode implies it will not take part in the subsequent measurements.
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7.1.4 In this screen you can enable or disable all the electrolytes
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Before using Deltas, verify the appropriate working order of your Analyzer, performing a
Quality Control since a problem may be hiding. Never apply Deltas if the equipment is not
precise, in other words, if it does not repeat a sample correctly.
See section “Maintenance” Page 82 y “Quality Control” Page 60.
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7.3.1 The sequence for the Modification of Delta values is as follows in the calibration
menu, press Opt.
7.3.3 Now you can change the delta value. Each electrode has a delta for each type of
sample
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The Analyzer allows you to use the following ranks according to the type of sample.
Serum Range Resolution Urin Range Resoluti
Na -12.7 a 12.7 0.1 e on
K -1.28 a 1.27 0.01 NaU -51.2 a 50.8 0.4
Cl -12.8 a 12.7 0.1 KU -9.92 a 9.92 0.08
Ca -1.28 a 1.27 0.01 ClU -51.2 a 50.8 0.4
Li -1.28 a 1.27 0.01
In case of using Deltas with extreme values, make sure the pattern and use is the
appropriate and/ or the equipment is working properly.
8. Electrode History
General Comments:
This menu contains all the data related to the installed electrodes, such as:
-Serial number.
-Manufacturing date.
-Date until which can be in stock without being installed.
-Date on which it was installed.
-Type of electrode.
Amounts of:
-Times that the analyzer was turned on.
-Calibrations.
-Serum measurements.
-Urine measurements.
-Rinses.
-Washes.
-Sodium washes.
This way is possible to verify how the electrodes are being used.
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8.1 To access this menu press Cal from the Root Menu.
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8.5 To access the history of an electrode, press the desired electrode. For example K:
Page 1 Page 2
Page 3
Page 1 Page 2
Page 3
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While the Analyzer is in this mode the automatic operations of calibration and washes are
canceled.
In this mode two operations are executed:
-Wet A&B: It is performed when it would have made a two-point calibration.
-Wet A: It is performed between each Wet A&B.
In this way the performance of the Pack is improved, without losing the benefit of
maintaining of electrodes, valves and tubing.
We recommend to keep the Analyzer on 24/7 the 365 days of the year.
Screen Saver
While the Analyzer is in standby mode, if the operator touches the screen and instead of
executing the action in the reasignable key (left) presses menu and navigates through the
menus, alter 5 minutes of inactivity, the Analyzer goes automatically to the standby screen.
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While the analyzer measure or calibrate, it will need to rinse the electrodes. The rinse
renews the Std. A in the electrodes preventing the mixing of different substances Turing
the different process, also clean the flowing circuit removing bubbles, clots, dirt, or other
substance that can change the result of the measurement or calibration.
2. Automatic Rinse
3. On Demand Rinse
3.1 It can be performed on the Operator’s demand through the sequence starting from the
principal screen pressing menu:
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3.5 When the rinse start the analyzer will charge and wash with Std. A .
3.6 When the process is complete, the analyzer will show the rinse screen:
4. Automatic Clean
4.1 The analyzer will need a Clean every 24Hs. When this time from the last clean were
passed the analyzer will show. Dose in a tube clean solution and then press clean.
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4.2 Move the handle to its Tube position, put the Cleaning Solution and press Fill.
4.3 When ready will make a beep, show a screen that says remove. Remove the tube and
move the handle to its standby position.
4.5 When the clean finishes will need a 2 point calibration. Will show it in the screen, after
1 minute will start the calibration automatically.
4.6 When the calibration is complete, the Analyzer will be Reddy to measure.
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5. On Demand Clean
5.1 It can be performed on the Operator’s demand through the sequence starting from the
principal screen pressing menu:
5.4 Press Cln and move the handle to its tube position to start.
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5.6 When ready will make a beep, show a screen that says remove. Remove the tube and
move the handle to its standby position.
5.8 When the process is complete, the analyzer will show the rinse screen:
6. Sodium Conditioner
Pass the sodium conditioner when the electrode has lower values, higher or instability in
the measurement.
JS Medicina Electrónica recomends to replace simultaneously the Fill Port cleaner with
®
the Pack Diestro .
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Drop
Fig. 32 Drop
The access to the new wash settings is detailed in the following steps:
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7.3 By increasing the amount of steps, the sample will recede more, so if a large number
is configured it is possible that during the wash the needle drops, decreasing the life of the
Fill Port cleaner. The suggested value is 700 but it should be corroborated on your
Analyzer.
7.5 Pressing Esc twice you can return to the main menu.
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9 - PURGE
1. General Comments
During this process the tubing of the Pack and the analyzer are filled with both
calibrating solutions.
2. Automatic Purge
This is performed automatically when a new Pack is installed in the analyzer, or when
installing a Pack with remaining volume previously used in another equipment.
If for any reason, the tubings of the Pack in use get disconnected, it is essential to perform a
Purge manually via the keyboard. Refer to “On Demand Purge”. Otherwise, it comes to
calibration and/or washing errors.
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3.5 When the purge start the display shows the sequence:
3.6 When the process is complete, the analyzer will show the rinse screen:
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10 – QUALITY CONTROL
1. General Comments
The Diestro analyzer has the ability to perform statistical calculations to assist the operator
in the quality control of your equipment. The QC ampoules usually come in 3 levels low,
medium (usually the normal value) and high.
Take major safety precautions regarding Bio safety. Handle with gloves.
Greater amount of control samples measures, more accurate is the analysis. The analyzer
allows the operator to store up to 22 samples of each level in its internal memory.
The analyzer calculates statistics with 5 samples by level or more (up to 22); with fewer
samples won't calculate statistical results although it will store the results.
If the operator wants to corroborate the specifications of the analyzer must perform 22
measurements and have the equipment in optimum conditions of maintenance.
Statistical calculations are: average value, standard deviation and coefficient of variability.
You can choose the level to evaluate, press QC1 if you want to measure the level 1,
QC2 for level 2 and for level 3, QC3 do not interleave levels, make all measurements of
one level and then another and the remaining then. The example we will explain in the
manual is for level 2, for other levels is exactly the same, entering by the corresponding
option.
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Pressing Clear, you must confirm and the memory with previous results will be deleted.
If you press Mem, you can view the memory of the chosen level with the results for each
electrolyte.
“Yes” means that the sample enters statistics, if you press Yes/No change the status of
included or not included in statistics.
“No” is for a sample that was loaded with bubbles or for some reason the operator wants
to put it out of statistics.
The equipment sets in “No” the 2 first samples, because it is understood that they are
conditioning samples. The operator is free to put them into “Yes” when he wants, as well
as placing in “No” to any other.
With arrows memory can be explored; the number between the arrows is the number of
sample within the 22 possible that is watched at this moment.
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If you press Print, a ticket with all including measurements and statistical values will be
printed (see next page).
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If you press ESC, a confirmation is asked, because if you are within a measurement
process, exits and returns to enter, clears the memory of results and starts a new cycle of
measurements, this is so to not mix controls carried out in different hours or days.
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4. Delta Corrections
In some cases during a Quality Control, some difference may arise in the results obtained
by the Analyzer regarding the ones given out in the result chart of the chosen
Control. This situation can be solved using Delta Correction.
Delta Correction allows you to correct the results obtained by the Analyzer, in such a way
that they can be matched or leveled with those given out by either other measuring
equipments, Internal or External Quality Controls, or desired Standards.
The Analyzer comes out of the factory with a Delta= 0.00 for every ion and types of
sample, which can be modified by the operator all the time.
Delta Correction can be applied independently for each ion and according to the type of
sample (Serum or Urine).
The value of Delta Correction (Delta) depends on the desired measuring result.
Example: If the average result outlined by your Analyzer for Na is 140, and your
Control indicates
Na = 144, you can level your Analyzer to the Control placing a Delta= 4.
If your Control indicates
Na = 137, place a Delta = - 3.
5. Definitions
Precision is the ability to obtain the same result upon repeated measurement of a
specimen. It is verified by the Standard deviation and coefficient of variation.
Accuracy or recovery is the ability to recover the correct amount of analyte (the assigned
value) present in the specimen. It is verified comparing the average value obtained with
the assigned value provided by the QC´s manufacturer.
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11 - CLOCK
1. Definition
The analyzer is able to memorize the time and date even thought the analyzer is power off
for a long time.
2. Clock Adjust
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2.4 Now you are able to change the time and date of the analyzer.
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12 – RESULT STORAGE
1. General Comments
Allow the operator to have access to previous measurement results, ordered by sample’s
number. The analyzer can save the last 1000 measurement.
2. Measurement Result
2.1 Start pressing menu
2.4 Select sample number and press Result to see the measurement result.
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If you press Rinse, the analyzer will wash and you loose the sample, the analyzer after the
rinse will be ready for measuring again.
If Esc. is pressed the sample can be measured
2.2 Open the front panel to be able to position correctly the sample into the electrode
chamber.
2.3 When press Esc. the analyzer goes to Root Menu, press Meas.
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2.5 Select what the type of sample and move the handle to its Tube position.
2.7 In this moment, while is pressed, the sample moves forward filling the chamber.
If the sample was filled before entering this option (because a not filled error occurs) you
only have to keep press until the sample fills completely the electrode chamber.
2.8 When the chamber is filled, move the handle to its standby position to start measuring.
The user is the only responsible of how the sample is positioned. Position it from the reference
electrode covering the more electrodes you can according to the sample volume you have. But
remember that the reference electrode must always be in touch with the sample. Be carefull with the
electrodes that do not touch the sample, those results will be wrong. Is the operator's responsibility not
to bear in mind those electrodes results.
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Allows configuring the available outs in the Analyzer: Printer, Serial Out and choose the
language.
The Serial Out (RS232) allows connecting the Analyzer to a printer, or any other type of
Interface (for example a PC or data network).
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2.4 In this screen you can enable or disable the printer, serial out, change the language
and the laboratory’s data.
When pressed Print for example an asterisk will appear, which means that is enabled.
If pressed Print again the asterisk will disappear meaning that the printer is disabled.
The language can be changed by pressing the language button, switching between the
available languages.
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When editing:
<==> Next character.
Increase or decrease value.
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When editing:
<==> Switch to the next character
Choose the character.
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2.5 Pressing Esc. goes to the Root Menu or if the serial out is enabled will appear the
options for the serial out
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15 – ERROR MESSAGES
1. List of errors
Check the following chart for a list of errors
Insufficient Sample.
Sample with coagula
and fibrins.
Check sample.
The Sample Operator’s error. The operation in
Not Filled Check filling process.
Could not be Tubing and/ or process is not
Obstructions in tubing,
filled. Electrode circuit complete.
sampling, peristaltic and
obstructed.
electrodes.
Defective Peristaltic
Check valves.
Tubing.
Replace electrode or
contact technical service.
The measuring Tubing or Electrode
The operation in
No Empty chamber cannot circuit obstructed.
process is not
be emptied. Defective Peristaltic
complete.
Tubing.
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Internal Error Hardware or software Does not Calibrate. Contact technical service
01 error. Does not measure.
Hardware or software Does not Calibrate. Contact technical service
02 Internal Error
error.. Does not measure.
The balance
during
1 point
calibration
C differs from the
last
2 points
calibration. External interference
Repeat measurement or
during measurement.
The balance calibration
Bubbles in the circuit of
Turing 1 point Check obstructions in
liquids. Failure of the
L calibration differs
electrode. Failure in The result is not
tubing and electrodes.
from the last 1 Check Valve or Peristaltic
the measurement valid.
point calibration. Tubing.
channel.
Change Electrode
Sharp Bad ground
Investigate possible
differences connection.
interference from other
during the Noisy power line.
Q measurement
equipments or devices.
Contact Technical Service.
process.
Sharp
differences
during the
U stabilization of
the sample.
Low
measurements of Low measurements
Sodium electrode is dirty Pass sodium conditioner
sodium of sodium
The errors are displayed on the principal screen with an exclamation sign as shown in
the picture:
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(*) 1 minute should pass between the equipment is switched on and switched off. Otherwise
a Pack Error can be generated.
2. Internal errors 01 or 02
Some types of internal errors can be fixed with an alphanumerical code. This consists of
entering a code from the keyboard, (16 alphanumeric digit combination 0, 1, 2, 3, 4,
5, 6, 7, 8, 9, A, B, C, D, E, F) supplied by the Manufacturer from a code generated by the
Analyzer.
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2.7 From that point, the manufacturer will provide you a new code that you must enter in
the analyzer from keyboard pressing Mod.:
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16 – MAINTENANCE
The Analyzer has been designed to require an easy and minimum maintenance.
1. Daily maintenance
Take major safety precautions regarding Bio safety. The samples, capillary and adapter are
potentially infectious. Handle with gloves.
1.1.1 Keep the worktop and the surface of the Analyzer in hygienic conditions.
1.1.2 Clean all the surfaces with a soft cloth wet in 1:10 Sodium Hypochlorite Solution.
1.1.3 Decontaminate the Fill Port with a ISE Cleaning Solution REF IN 0400
1.2 Clean
To protect the Analyzer from possible contamination and from blockage and obstructions
perform a Clean daily.
It is recommended to make the clean at the end of the working day for remove possible
waste in the fluid circuit.
If the Clean is not performed 24 hours after any measuring, the Analyzer will not permit to
continue working until the Clean is complete.
2. Weekly maintenance
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The set frequencies are only preventative and indicative. Such frequencies can be
modified depending on the amount of processed samples or according to need.
Precaution. Potentially dangerous elements. Discard them according to the regulations currently in
force in your country for the treatment of Pathological Waste. Use gloves in the replacement.
In the following chart you will find instructions for components, suggested frequencies and
authorized service to perform such replacements:
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Clamping button
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The life of The Fill Port Cleaner is calculated for 800 samples for an estimated consumption of 100
samples day or 3 months for a consumption of 10 samples day.
JS Medicina Electrónica suggests replace the Fill Port Cleaner simultaneously with the
Pack Diestro.
Note that if a rinse is made without the Fill port Cleaner it will drip on the area below the
sample.
Note that if whole blood is passed then the time in which the Fill Port Cleaner is effective
may be decreased by having landslides or fibrin clots in the dressing cleaner.
The needle and the used Diestro Fill Port Cleaner may contain potentially infectious
waste: be cautious, wear gloves and avoid splashing.
Discard the cloth or towel and the used Diestro Fill Port Cleaner in accordance with the
clarifications in “Discard of Consumables”. Page 89.
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6.4 Remove the security seal of the new cleaning module as shown in figure
Fig. 13 Opening the Fill Port cleaner – Step 1 Fig. 14 Opening the Fill Port cleaner – Step 1
6.5 Present the new Diestro Fill Port Cleaner in front of the guide position, make sure it is
in the correct position and gently slide it on till hit the central wall of the analyzer.
Make sure the Fill Port Cleaner is in the correct position, with the label "Front / Front"
facing the operator.
Fig. 16 Placing the Fill Port cleaner – Step 1 Fig. 17 Placing the Fill Port cleaner – Step 2
Perform, clean and if necessary decontaminate all the surfaces of the Analyzer.
Prevent damage to the power cord during transport or storage of the analyzer. In case of
damage change it with a new one.
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7.2 If transportation involves large movements, but it will be reinstalled within a day,
proceed as follows:
7.3 If the analyzer will not be installed in more than two days.
1. Disconnect the caps of Std. A and Std. B.
2. Empty the equipment’s tubing.
a. In the Valve menu, open the A valve, then in manual movements menu, press
CW until the waste tubing is emptied.
b. Repeat the operation with the B valve open.
c. Repeat the operation with the M valve open
3. Connect a tubing to the couplings of Standard A and B of the analyzer and immerse in
distilled water, then proceed as in step 2 to wash all the circuit.
4. Repeat step 2 without the tubings immersed in water.
5. Disconnect the waste container.
6. Turn off the analyzer.
7. Close tight the bottles of the Pack. (Model of PACK without tubings REF IN 0100)
8. Do not tilt the Analyzer.
9. If necessary, pack for transport. Use the original box of the Analyzer with the
accessories to prevent hits and movements. If this box is not available, use a similar one.
10. Follow the installation procedures.
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8. Discard of consumables
To discard the consumables should proceed as usual in your laboratory according the
local rules or ask to the environmental authorities.
As orientation we recommend:
Close tight the Pack bottles and consider as pathological waste.
Close tight the Std. A and B bottles and consider as pathological waste.
The spare parts used with biological samples and not decontaminated are
pathological waste.
With each of these groups identified, contact to the corresponding company/s authorized
by the Ministry of the environment of its jurisdiction to discarding them properly.
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17 – SERVICE
1. General Comments
This is a feature of the software of the Analyzer which allows the Technician, the Operator
trained by the Manufacturer, or the Authorized Dealer to check and assess the fluid flow
and the state of the electrodes.
2.1 The Operator can access the Test Menu, following the sequence. First press Menu
2.2 Press Serv and then Test for entering Test Menu (Service Menu)
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Thus, in some cases it may be useful to determine which voltage generates a given
Sample in the Measuring Chamber.
The positioning of either the Calibrating Solutions or the Sample in the measuring
chamber can be performed manually as well as automatically.
3.1.1. Before the positioning is by hand, it is necessary to open the corresponding valves.
To do this press mV
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If you want to charge air, open Valve M and don’t put any sample.
Is not recommended to open more than one valve at each time because can enter air in the
piping system. If necessary, after all tests purge the analyzer
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3.1.7 In this screen you can move fluid, see the conductivity and the tension measured by
the electrodes
: The peristaltic turn in clockwise direction. Charge the electrode chamber with
Std. A, Std. B, sample or Air. Make that the solution that leave the electrode chamber go to
waste. (Direction right)
When is moving the peristaltic and 5 second after the peristaltic pump stops
rotating will show the value being measured by the sample detector with the existing liquid
in the measuring chamber, also appear a symbol that represent the measuring chamber
status:
Chamber Empty
Chamber Filled
3.1.8 Position the Solution or sample chosen pressing continuously. The indicator of
the Measuring Chamber state turns from empty ( ) into filled ( ) when the
positioning of the Std A is complete. Once the “Filled” message is visible, stop clicking on
the button.
In case it was necessary to move back the Solution in the Measuring Chamber, you MUST
ENABLE THE VALVE corresponding to the sample. See step 3.1.1 to 3.1.5
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Subsequently, you can press until the Solution is properly located in the Measuring
Chamber.
Five seconds after the Peristaltic Pump stops rotating, the display shows the voltages
generated by the chosen Calibrating Solution or entered Sample. Allow then to stabilize
during 30 seconds so that no significant variations are perceived.
Bear in mind only the voltages corresponding to the enabled electrolytes in the analyzer.
3.1.9 Press Esc. and go back to Service Menu. All open valves will be closed.
3.2.1 Press mV
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Bear in mind only the voltages corresponding to the enabled electrolytes in the analyzer.
4. Threshold Option
The “Threshold Option” allows you to modify the threshold conductivity from which your
Analyzer detects Std A, Std B, Serum or Urine.
To be handled only by trained Technicians. It will affect the liquid filling operation in case it
is altered improperly.
4. The access to this feature is displayed below, in the service menu press Thrsh.
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To be handled only by trained Technicians. It will affect the liquid filling operation in case it is
altered improperly.
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5.1 The access to this feature is displayed below, in the service menu press Needle
5.2 In this menu you can set the needle wash and Sample BIP (alert sound that
indicates the minimum amount of sample needed for the analyzer to measure
correctly). When the analyzer cleans makes the liquid recede so it can wash the
inside of the needle and drips onto the Fill Port Cleaner cleaning the remains of
Sampling serum and fillings.
By increasing the number of steps, the liquid recede more and increases the drip.
Note: A high cleaning value will reduce the performance of the Fill Port Cleaner.
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18 – ELECTRODE REPLACEMENT
1. Replacement
Purchase original spare parts from the manufacturer.
To replace an electrode, perform the following sequence:
1.1 Disconnect the power supply of the analyzer from the Voltage Line.
1.2 Open the front panel of the Analyzer and loose the holding screw in the top right of
the electrode lock and open the electrode protector in order to have access to the
electrodes.
1.3 Take out the electrode lock by loosing the holding screw in its back part.
1.4 Disconnect the electrode cable to be replaced. If necessary, also disconnect this
cable from the remaining electrodes located on the right of the one to be replaced.
The angular cable is placed by force in each of the pins.
1.5 Loosen the terminal/s of all electrodes in order to move the electrodes which are
1.6 Remove the defective electrode.
1.7 Place the new electrode with the same couplers and relate it to the remaining ones.
1.8 Put again the electrode lock.
1.9 Connect the electrode cables again to the corresponding pins.
1.10 Put again the electrode protector and close the front panel.
1.11 Switch on the equipment and check that it performs the Washing and Calibration
properly.
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Fig. 39 Opening the electrode protector and taking out the electrode lock.
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19 – ELECTROLYTE EXPANSION
1. General Comments
One of the features of your Analyzer is to be an ion expandable device, i.e. it admits
adding ions until it reaches the maximum configuration: Na, K, Cl Ca and Li.
The inclusion of new electrodes, called Expansion, can be performed remotely and
consists of the following steps:
2. Installation in the Analyzer of the Electrode/s and accessories that make up the
expansion.
This can be performed by the Operator, following the guidelines supplied by the
Manufacturer with the new electrode.
2.1 Expansion enabling in the software
This consists of entering a code from the keyboard, (16 alphanumeric digit combination 0,
1, 2, 3, 4, 5, 6, 7, 8, 9, A, B, C, D, E, F) supplied by the Manufacturer from a first code
generated by the Analyzer.
2.1.1 Generate a Code in your Analyzer following the sequence:
Enter Menu by pressing Menu key
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2.2.1 From that point, the Manufacturer will provide you a new Code that you must enter in
the Analyzer from keyboard pressing Mod. key:
2.3.1 When the sequence is complete, it is necessary to enable by keyboard the new
electrode added, this step verify that the code was entered correctly
The enabled ions are showed with an asterisk.
If the ion is not enabled it is showed without the asterisk. Press the desired ion to enable it.
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2. Remove the couplers of the Peristaltic Pump Tubing from the bracket.
Bracket
4. Connect the waste disposal tubing to the replacing peristaltic pump tubing couplers.
5. Place one of the couplers of the peristaltic pump tubing in the bracket. Wrap the
peristaltic pump head with the tubing, so as it makes contact with the head roller and insert
the free coupler into the bracket.
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Pinch tube
Teflon support
Support screw.
Steel axle
Capillary for
sampling
Cautions:
-Once the battery is replaced. Connect the power supply and charge the battery for 8
hours.
This means that during this period of time the operator cannot perform any measurements
with the analyzer.
-Before starting to perform measurements, perform a two-point calibration. (See section 7)
-This is a maintenance free, sealed lead battery.
-Follow the instructions printed on the battery for its disposal.
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24 – REFERENCE VALUES
1. Electrolyte Range
Laboratory must establish its own criterion to determine the normal ranges and critical
values of the electrolytes.
The following chart is provided as a guideline:
The Normal Values for Urine Samples are relative, since they depend to a great extent on
the diet and treatment the patient is subjected to.
In the chart, Reference Values for Urine Samples of 24 hours are indicated in mmoles.
To obtain the value in mMoles/24 hours, it must be multiplied by the 24 hour Urine volume
from such patient, expressed in liters.
Electrode Na K Cl Ca Li
Span (mV) 4.0-7.0 12.0-19.0 3.0-7.0 3.0-7.0 8-13
These values are only for reference. They depend on the electrode performance, time from
the installation, correct working of the analyzer and the Pack.
25 - CABLES
Connection cable between Diestro 103AP Analyzer and a PC
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26 - DIAGRAMS
Printer
Touchpad
Pack
Display
Clamping button
Fill Port
Pack’s Tray
External barcote
Fig. 47 Front View
reader (Opcional)
USB
connector
uChip connector
RS232
connector
External
barcode reader
connector
Power supply
connector
Ground
Borne
Electrode
wire
Electrode
assembly
Electrode
lock
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27 – TECHNICAL SPECIFICATIONS
1. Size and Weight
Height: 270mm
Width: 164mm
Depth: 465mm
Weight: 5,4 Kg.
Weight with the optional battery: 7,4 Kg.
Pack’s weight: 1,4kg
Power supply weight: 215g
ISE Urine Diluent weight: 165g
ISE Cleaning Solution weight: 120g
6. Samples/ Hour
Up to 60 Samples/Hour
10. Electrodes
Maintenance-free Ion Selective Electrodes.
12. Battery
Lithium Cell 3V CR2032
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1. Definition
cK+ (P) is the potassium concentration (K+) in plasma, whereas cK+ (aP) is the equivalent
for arterial blood. In the Ion Analyzer it is shown as K.
2. cK+ indicates
Our body has a total quantity of 3000 - 4000 mmol of potassium of which the major part is
intracellular. The plasma (and the extra cellular fluid) only contains about 4.0 mmol/L,
totaling 50 mmol (the extra cellular fluid is about 12 L.). However, a given plasma
concentration may be found with any body potassium level. Although extra cellular
potassium only accounts for 1-2% of the total potassium, it is of great importance, since
one of its main functions is to mediate the regulation of the entire potassium balance in the
organism. A normal potassium is essential to regulate cardiac function. Values outside the
range of 2.5-7.0, are lethal.
3. Reference Ranges
cK+ (aP) Reference Ranges (adult): 3.7- 5.3 mmol/L.
4. Clinical Interpretation
5. General Comments
High cK+ levels can be caused by Hemolysis. This is because red blood cells present a
higher concentration of this ion regarding serum or plasma, from what there may be
observed an artificially augmented cK+.
It is very common when a traumatic extraction is performed, but it may also occur when
taking a scant sample, (capillary sample). To minimize Hemolysis risks, it is advisable to
separate serum or plasma as soon as possible from the globular Packet, as well as mixing
the sample softly with anticoagulants. When Hemolysis is evident, the values obtained are
very high. For this reason, if the coloration seems to be more reddish than normal in
plasma and serum samples, it is recommended to either repeat the sample or add a
comment on the color next to the ck+ results.
1. Definition
cNa+ (P) is the concentration of sodium in plasma. The systematic symbol for arterial blood
is cNa+ (aP). The Analyzer symbol is Na.
2. cNa+ indicates:
The body has a total sodium level of about 60 mmoL/Kg, the majority of which is divided
between the bone and the extra cellular fluid. The plasma level (about 140 mmol/l), is
regulated by the plasma content of sodium, water and intracellular potassium. Therefore,
high-plasma sodium may be due to low-body water – or vice versa. It represents about the
90% of the inorganic cations in plasma, making it responsible for almost half the osmolality
of the plasma.
3. Reference Ranges
cNa+ (aP) Reference Range (adult): 135 -148 mmol/L.
4. Clinical Interpretation
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5. General comments
Regional edema in the sampling area can cause false decreased values of cNa + .
1. Definition
cCl- (P) is the concentration of chloride (Cl-) in plasma. The systematic symbol for arterial
blood is cCl-(aP).The Analyzer symbol is shown as CI.
2. cCI indicates:
The chloride ion is the body’s major anion in the extra cellular fluid. The plasma level is
about 100 mmol/L, representing the largest fraction of inorganic ions. Sodium and chloride
together represent the majority of the osmotically active plasma components.
The kidney plays a major role in the body’s handling of chloride. Chloride accompanies
a large part of the sodium filtered by the glomerulus and is also active in the
chloridebicarbonate exchange.
3. Reference Range
cCl-(aP) reference range (adult): 98-109 mmol/L.
4. Clinical Interpretation
cCl- itself as a single parameter is of minor importance in most settings. However, low
values can cause muscles seizures, apathy and anorexia. High values may cause
Hyperchloremic metabolic acidosis.
5. General Comments
The major importance of cCl- is in relation to calculation of anion gap.
1. Definition
cCa++(P) is the concentration of Calcium in plasma. The systematic symbol for arterial
blood is cCa2+(aP). The Analyzer symbol is Ca.
2. cCa++ indicates
Ionized Calcium in plasma is the metabolically active part of total calcium, making up
around 50% of the total calcium. Total calcium in plasma is in part bound to proteins
(mainly albumin) 40%, and the remaining 10% bicarbonate, citrate, phosphate, and lactate
anions. The binding to proteins depends on pH. The ionized calcium is necessary for a
number of enzymatic processes and membrane transport mechanisms.
It thereby plays a key role in blood coagulation, cellular growth, neuro-muscular
transmission, and a series of other functions essential to life.
3. Reference Range
cCa++(aP) reference range (adult): 1.00 -1.40 mmol/L ( 4.0 – 5.6 mgrs%).
4. Clinical Interpretation
5. General Comments
There are a number of factors that can affect the cCa++ measured values. To minimize the
mistakes that may be made it is recommended: no more than 30- second estasis applied
to the extremity where the sample is being taken; the patient should remain
sitting for more than 5 minutes before the venipunction; the use of small tubes without
anticoagulant; use tubes with balanced heparin for whole blood or plasma; complete the
tube with sample so as to minimize air drawn into it, and process the sample within one
hour after the sample has been taken.
Whole blood samples taken in tubes with Li or Na heparin, show low cCa++ values
compared to those obtained in the same sample without heparin.This is because heparin
completes and diminishes cCa++. There are commercially balanced heparin which would
diminish this effect. If the amount of heparin added to the tube or syringe may be
diminished, then this mistake would diminish as well, but low levels of anticoagulant
increase the risk of sample coagulation.
Anticoagulated blood with Oxalate or EDTA is not accepted since these compounds are
strong calcium chelators. Venous estasis and an upright position may contribute to elevate
calcium. Estasis produced by keeping tourniquets longer than 1minute may lead to
anaerobic glycolysis with lactic acid production, which diminishes pH and varies the free
Ca++ since the Ca-protein bind is dissociated, showing augmented cCa++ values.
1. Definition
cLi+ (P) is the concentration of lithium (Li+) in plasma, while cLi+ (PDB) is the equivalent to
the arterial blood. In Ion Analyzer displays as Li+.
2. cLi+ indicates
Lithium is a metallic monovalent cation that is usually absent in the body. It is used to treat
psychosis manic - depressive. The drug produced significant effects, but may be
significant clinical complications associated with their use. The binding of lithium to plasma
proteins is less than 10% and their average life is 7 to 35 hours. Its elimination is mainly
urinary (95 to 99% of the daily intake, after fixed state).
3. Reference Range
Lithium has a very narrow therapeutic range. The initial doses are between 0.80 and
1.20 mmol / L.
Reference range CLI + (AP) (adult): 0.50 -1.00 mmol / L
5. General Comments
During treatment with lithium and during maintenance (prophylaxis) is important to adjust
the dosage to achieve plasma levels required because the lithium can cause acute toxicity
if their concentration is just above the therapeutic range (about 2.00 mmol
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/ L, although some patients seem to be more sensitive and have side effects such as
tremors or confusion with even lower doses).
Increases chloride elimination: in rich-salt diet, during the diuretic effect of saluretics and
other similar preparations; in certain acute nephropathies (tubular necrosis), in the poliuric
phase that follows anuria; in chronic nephropathies (pielonephritis, chronic
glomerulonephritis or polycystic kidney), with the saline incontinence syndrome, in
suprarenal insufficiency of Addison’s disease; hypernatruria; it appears in Schwartz-
Bartter syndrome (excessive ADH secretion).
Elimination of Urine Potassium varies within great limits according to the diet. On a
normal mixed diet, normal potasuria oscilates between 1.5 and 3.5 g/ 24 hours, i.e. it does
not exceed 90 mEq./day.
Measurement Technology
Ion selective electrodes (ISE) measure electrolytes by two different technologies, direct
and indirect, commonly known as Direct ISE and Indirect ISE (ISE = Ion Selective
Electrode).
Direct ISE
The automatic Analyzer employs for electrolyte determination the Direct Ion Selective
method which is based on the properties of its transducers or sensors (electrodes) to be
selective to a specific ion in solution.
This is achieved because the membranes of the Ion selective Electrodes develop a
potential measured against a stable reference electrode of constant potential related to the
activity of this particular ion for which they are selective. Such potential is due to the
Nernst equation.
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RT
E E0 ln ai . (+ for cations and – for anions)
nF
RT
But ai fi ci , then E E ln( fi ci )
0
nF
E = Electrical potential measured
Eº = Electrical potencial (constant) that depends on the measure system.
ai = Electrolyte activity.
R = General constant of gases.
T = Temperature
n = Electrolyte Valence.
F = Faraday constant.
ci = Electrolyte concentration.
fi = Electrolyte activity.
Enunciating the equation in terminus of Analyzer functions
E E 0 P ln( fi ci )
This is calculated by the Analyzer measuring the Standard Calibrators A and B and
knowing the concentration of each electrolyte.
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1. Connect the keyboard/bar code reader in the connector installed in the back of the
analyzer. (See Fig. 1)
USB
connection
RS232
connection
External barcode
reader and keyboard
connection
Power supply
connection
Ground
connection
2. Entering information in the Measuring process (See section 5.3 and 6.3 in the user
manual)
2.1. When the needle is out and the next figure appears in the screen, press info
2.2. Type the patient ID in the Keyboard and press enter or read the bar code of the
sample with the bar code reader.
2.3 To continue with the normal procedure of measurement press fill and follow the steps
described in the manual
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The method consist in compare the measurements of the diestro analyzer with the
analyzer to emulate and perform a curve with the form:
B= Quadratic value
A= Lineal value
Constant value = Delta
For more information about the quadratic equation and the way of calculate
this parameters please contact Technical service
Delta Correction allows you to correct the results obtained by the Analyzer, in such a way
that they can be matched or leveled with those given out by either other measuring
equipments, Internal or External Quality Controls, or desired Standards.
Before using Deltas, verify that the analyzer works properly. Never apply Deltas if your
analyzer is not precise, in other words, if it does not repeat the measures correctly.
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3. Now you can change the delta value. Each electrode has a delta for each type of
sample.
3. Now you can change the quadratic factor (Sqr) and the lineal (Lin) value of each ion.
4. Edit the the quadratic factor (Sqr) and the lineal (Lin) value digit by digit beginning with
the sign.
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Serum Urine
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3. Press Out.
*
“ ” = Out activated
Displ. Time is the time (in seconds) the results of the calibration and
measurements are displayed on the screen
Beeper: Yes (The analyzer will make sound alerts)
No (The analyzer is in silent mode)
Then continue with the steps in the manual for the case of the Wash.
See section “Rinse and Cleaning” Page 51.
The “Serial Out” parameter must be changed. It can be found in the Serv->Conf->out
menu.
This parameter includes the following options:
No: Serial output disabled.
Ticket: Transmits through the serial output (RS232) calibrations and measurements
performed by the analyzer in the ticket printer format (equal to the printer ticket).
>Net: Send the measurement data in a string of fields separated by ";" in the
following format:
Note: In this mode the calibration data or measurements of quality control will not
be reported by the serial port. Only the measurements will be reported to the net.
Urine measurement in analyzer with Na-K-Cl-Ca configuration, urine measurement without errors, no
patient ID. All ion units is [mmol/l].
# 8;&;2012/10/13 16:39:57;NaO=251.0 [mmol/l];K O= 21.20 [mmol/l];ClO=251.0 [mmol/l];;;CR
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Note: In the measurement of urine is added an "O" after the ion measured and
reported only sodium, potassium and chloride, the other fields are empty report.
That is never measured Ca and Li in Urine
Setting baud rate, flow control, carriage return and Line Feed.
Pressing Esc in the serv-> Conf-> Out menu having serial out enabled a screen with the
options will appear:
Baud: (Baud rate) The speed of transfer of the serial output data.
Xon – Xoff: It is a choice of serial communication protocol.
Serial communication is: (8N1)
8 data bits
1 sop bit
No Parity
<CR>+<LF>: Some printers or interfaces need this option. (Appears only when the serial
output is configured as a ticket)
In the case the result of a performed measurement must be reported to the network you
can enter in the memory measured results in the meas-> Mem menu and navigate the
measurements using the "v" and "^" to find the searched measurement.
Note: In the search screen you will find the patient ID, sample number, date and time.
Once measurement is found press "Resul" to see the measurement.
Pressing "> Net" measurement data will be sent via RS232.
Yes: Each time you finish a measurement operator gives the OK (pressing "> Net")
for data to be sent via RS232 or "ESC" to cancel sending.
No: Each time you finish a measurement data is sent automatically by RS232.
With error: Each time you finish the measurement and there is an error in
measuring the operator must give the OK (pressing "> Net") for data to be sent via
RS232 or "ESC" to cancel sending. Data without error is sent automatically to the
net without validation by the operator.
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Install by Date: Use of the component must commence by that date (maximum) to
guarantee the component warranty period.
WARRANTY
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