Manual Roller 20 PDF

Ed. 1 Rev.
13 -2014, April, 05
ROLLER 20 LC
OPERATOR MANUAL
Software version 6.51C
Capillary Micro-photometer for the Erythro-Sedimentation Rate (ESR)
In Vitro Diagnostic Medical Device for Professional Use
Copyright  Alifax S.P.A.

This manual contains ALIFAX reserved information. All rights reserved.
Unauthorized copying of this manual or parts of it is prohibited.
ROLLER 20 software is provided only with restricted and limited rights based on Italian regulations.
OPERATOR MANUAL
ROLLER 20LC(SI R20-LC)
Ed. 1 Rev.13 -2014, April, 05
SI R20LC – ROLLER20LC
USER MANUAL REVISIONS
Rev. Description Issue date
13 Inserted EAC certification Logo 05/04/2014

12 Technical specification upgrade (page 5) 05/02/2014
11 Technical specification upgrade (page 5) 15/01/2014
10 Page 54 updated +revision page inserted 30/09/2013
9 Page 21 updated 20/12/2012
8 Technical sheet Upgrade + add error messages on chapter 28 (alert list) 27/08/2009
7 Re-written chapter 32 and add APPENDIX B Sanitation module. 02/04/2008
6 Chapter 13 updated 30/09/2009
5 Re-written the “Priming process” chapter 18/05/2009
4 “Washing procedure” chapter updated 20/01/2009

3 Rewritten chapter dedicated to maintenance. 27/08/2009
2 Technical sheet Upgrade (chapter 2) 06/02/2008
1 Upgrade Latex Calibration and Control Procedures 27/04/2007
0 Release software version 6.51C 20/11/2006
Page 1
ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC USER MANUAL
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
Summary Page
1 SIMBOLS INDEX AND LABELS .............................................................................................................................. 3
2 TECHNICAL SPECIFICATIONS (D102.06.03 - 1.7 –27.08.2009)........................................................................................... 5
3 WARNINGS TO ENSURE A CORRECT INSTRUMENT USE................................................................................. 9
4 UNPACKING AND INSTALLATION....................................................................................................................... 11
5 VOLTAGE SELECTOR AND FUSES REPLACEMENT ........................................................................................ 12
6 SYRINGE CHOICE ................................................................................................................................................ 13
7 KEYBOARD SPECIAL FUNCTIONS ..................................................................................................................... 14
8 SWITCH the ANALYSER ON ................................................................................................................................ 15
9 WASTE TANK LEVEL MESSAGE ......................................................................................................................... 15
10 MAIN MENU .......................................................................................................................................................... 16
11 TO CHANGE DATE & TIME .................................................................................................................................. 17
12 PAPER LOADING PROCESS INTO THE PRINTER ............................................................................................. 18
13 SMART CARD TO INCREASE CREDITS ............................................................................................................. 19
13.1 AVAILABILITY TEST INCREASING ...................................................................................................................... 19
13.2 UNIVERSAL CARD ............................................................................................................................................... 19
13.3 SMART CARD ERRORS ....................................................................................................................................... 20
14 USE OF PAEDRIATIC TEST-TUBE ...................................................................................................................... 21
15 TEST TUBES INSERTION READING THE ID CODE (by External Bar Code Reader) ......................................................... 22
16 TEST TUBES INSERTION AFTER HOST INTERROGATION .............................................................................. 24
17 TEST TUBES INSERTION (MATCHED WITH PATIENT ID CODE TYPED MANUALLY) .................................................................... 26
18 TEST TUBES INSERTION (MATCHED WITH AUTOGENERATED ID CODE)............................................................................... 27
19 PRIMING PROCESS and MEASURING PHASE .................................................................................................. 28
20 ESR RESULTS PRINTED OUT ON PAPER ......................................................................................................... 29
21 RESULTS REPRINTING ....................................................................................................................................... 30
22 TEST TUBES EXTRACTION ................................................................................................................................. 30
23 MANUAL WASHING PROCEDURE ...................................................................................................................... 31
23.1 WASHING USING 2 TEST TUBES ....................................................................................................................... 31
23.2 WASHING USING 3 TEST TUBES ....................................................................................................................... 31
23.3 WASHING PROCEDURE FOR MAINTENANCE (useful even to unlock the needle and capillary ) ............................................... 31
23.4 WASHING PROCEDURE IN CASE OF DAILY CONTROLS BY MEANS OF LATEX KIT .................................... 31
24 LATEX FOR QUALITY CONTROL PRESENTATION. .......................................................................................... 33
24.1 QUALITY CHECK USING LATEX CONTROL KIT ................................................................................................ 33
24.2 RECALLED LATEX ID CODE ................................................................................................................................ 35
24.3 LATEX CODES TYPED MANUALLY ..................................................................................................................... 35
25 QUALITY CONTROL TOOLS PRESENTATION ................................................................................................... 36
25.1 QUALITY CONTROL BY MEANS OF LATEX CONTROL KIT .............................................................................. 37
25.2 HEMATIC STATISTICAL DATA PRINTOUT ......................................................................................................... 38
25.3 DISTRIBUTION PRINTOUT .................................................................................................................................. 42
25.4 WATER DATA PRINTOUT - Graph meaning ........................................................................................................ 44
26 GAIN ADJUSTMENT ............................................................................................................................................. 45
27 MAINTENANCE TIME ........................................................................................................................................... 46
28 GENERIC ERROR LIST ........................................................................................................................................ 47
29 ALERTS LIST and LATEX ERROR LIST .............................................................................................................. 48
30 NEEDLE REPLACEMENT ..................................................................................................................................... 49
31 SOFTWARE REVISION HISTORY........................................................................................................................ 51
32 SANITATION PROCEDURE.................................................................................................................................. 52
33 BEFORE SWITCHING OFF THE ANALYSER ...................................................................................................... 52
34 REFERENCES ...................................................................................................................................................... 53
35 APPENDIX A - SANITATION FORM ..................................................................................................................... 54
Note: The paragraphs written with the italic characters (as on this note) were added or modified as regards
the previous version of the manual.
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OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
1 SIMBOLS INDEX AND LABELS

Inside this manual and also in the instrument, can be find out many symbols used internationally.
Here we describe the meaning of this symbols:
Symbol MEANING Symbol MEANING

Attention, read the instruction
_ REF _ Product Code
for the use
Manufacturer Ground terminal connection
In Vitro Diagnostic Serial Number of the

SN
Medical Device instrument
Caution: parts in
movement inside the Waste tank
instrument
Attention: Biologic
risck
Attention: High
voltage
Attention:
Sharpened objects
inside the
instrument
ROLLER 20
_ REF _ SI R 20-LC
_ SN …………………..……….……
(yyyy/mm) ………..…………....
Power 115/230 Vac 50/60 Hz 225 VA
Mains Fuses T2.5A 5x20 mm
SIRE Analytical Systems Made in ITALY Rx Only (USA)
THERMOSTAT TEST OK
Date:
SIRE Analytical Systems
PWR SUPPLY TEST OK

Date:
SIRE Analytical Systems
Page 3
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
Roller20 s.n. ______
Technical Service Tel. No.
_______________________
FUSE
2,5AT5x20 or
3,15AT5x20
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OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
2 TECHNICAL SPECIFICATIONS (D102.06.03 - 1.9 )
OPERATIONAL SPECIFICATIONS
Equipment name: ROLLER 20 (code SI R20-LC): model with thermoplastic white cover and Latex
Control management.
Equipment description: Automatic Analyzer for the determination of human blood Erythrocyte
Sedimentation Rate (ESR).
Analysis principle: Photometrical capillary stopped flow kinetic analysis.
Results: Given in mm/h in the range from 2 to 120 mm/h.
Sample requirements: - the sample must be of whole blood collected in EDTA anti-coagulant.
- the blood sample must be neither coagulated nor hemolyzed.
- it would be better to test the sample within 4-6 hours from venipuncture or within
24 hours if kept at +4/+8 °C, provided it is rewarmed to room temperature before
testing.
- the blood samples must remain capped (don’t uncap and recap them since the
instrument’s performances would be affected).
- the minimum blood volume (dead volume) is 800 microliters, the working volume
is about 175 microliters while about 87 microliters per sample are withdrawn from
the first and second samples for priming. In case there is only one sample, the
amount withdrawn for priming is around 175 microliters.
- samples separation inside the capillary using air bubble of about 530 mm (255
microlitres).
Tube requirements: Test-tubes 13x75 like BD Vacutainer® or Greiner Bio-one or with 13 mm diameter
and from 75 to 83 mm high, cap included, verifying that the sample volume does
not exceed the 50-60% of the total volume of the test-tube.
Optional Terumo® cap adapter for Terumo Venojet II® tubes
Optional Sarstedt® cap adapter for Sarstedt Monovette® tubes
Operative performances: Samples mixing can be programmed in speed (60, 32 and 24 RPM) and in
number of rotations, from 2 to 1000 rotations (recommended 32 RPM @ 140
rotations, about 4,4 minutes of mixing).
First result available after 4,4 minutes of mixing and 20 seconds of analysis, the
other results (from 2nd to 18th) are produced in 20 seconds each.
18 samples processed in 10 minutes (100 samples per hour) without considering
the time taken for loading and removing the test-tubes from the instrument.
The above throughput could be delayed in case of connection to the Host
Computer with reply output time more than 1 second.
-Audible alarm in case of error or malfunction: The instrument emits a series of
62,5dBA sounds until the error is solved.
Capacity: 20 position wheel, 18 positions for samples plus 2 positions for washing test tubes.
Analytical performances (obtained with 3 ml Test-tubes):

Trials made using TEST1 as comparison instrument [1]:
Correlation: R2 = 0.97, Slope: 0.942
Repeatability:
Evaluated by performing 5 replicates using the same samples ob blood [2]
ESR values N° Coefficient of

range (mm/h) Samples Variation (%)
∼ 0 – 20 10 8.96
∼ 21 - 40 11 4.06
∼ 41 - 60 8 2.78
∼ 61 - 80 5 2.70
∼ 81 - 120 3 2.38
37 4.99
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OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
To do this evaluation, has been used 37 samples, obtaining a mean

CV% = 5% ranging from ∼ 0 - 120 mm/h
Stability of samples stored for 24 h at room temperature:
In order to view the effects of different methods of storage on the ESR value, 272
K3EDTA-anticoagulated whole blood samples, some of which have been stored at 4
°C and some others at room temperature, have been analysed after 4 hours and after
24 hrs on TEST1 device.
Good correlation was found between the results taken at 4 hours and those taken at
24 hrs on the samples stored at 4 °C (r=0.980). Those stored at room temperature did
not correlate quite as well as those stored at 4 °C, but still had very good correlation
(r=0.917) (3).
Method limitations: 1. The erythrocyte sedimentation rate is a phenomenon confined to fresh blood and
transient (4), not a haematic matrix component (at corpuscular / molecular level). The
procedures used to determine the ESR cannot be calibrated as they are susceptible
to a variety of errors (temperature, haematocrit, erythrocyte mean corpuscular
volume, plasma viscosity, etc.)(4). Based on the acquired experience on TEST1, also
ROLLER 20, being a member of the same family, can be considered affected by
these variables to a limited degree. For this reason it is possible to observe
instrument performances deviations compared to other procedures if the above
variables are not taken into account.
2. Erythrocyte sedimentation remains an only partly understood phenomenon….is a

nonspecific reaction (from a clinical point of view)… (4) that is affected by several
technical aspects (5).The ESR is often normal in patients with cancer (5).
International guidelines for diagnosis and management of multiple myeloma do not
mention the Erythrocyte Sedimentation Rate (6). However there are national
guidelines that include ESR together with other clinical tests. It is then necessary to
point out that even though TEST1 analytical performances have been confirmed in
patients affected by multiple myeloma (7,8), there have been some cases of patients
affected by multiple myeloma in which TEST1 has reported clinically negative ESR
values in comparison to other methods. Based on this experience there could be
cases in which ROLLER 20 gives low ESR results likewise TEST1 in presence of
Multiple Myeloma.
It is then highly recommended to perform other tests together with the ESR in the
diagnosis of cancer since a normal ESR value is not enough to exclude that the
patient is not affected by this pathology.
Furthermore in presence of this disease it is possible to observe deviations form
other methods since other phenomena in addition to the rouleaux formation can
contribute to the sedimentation like for example amorphous aggregates formation
(crystallization of paraproteins or mineral materials like calcium) resulting from bone
tissue alteration.
3. Samples mixing is programmed at the beginning of the analysis with the purpose
of disaggregating erythrocytes. An inefficient disaggregation or micro-clots presence
can affect the results given by the instrument that in fact measures erythrocytes
aggregation kinetics.
4. The above instrument performances have been obtained using test tubes with a
capacity of 3 ml and 13x75 mm size with K3EDTA anticoagulant. This kind of tubes
has a sufficient air volume that favours the blood homogenization and consequently
the results reproducibility.
ENVIRONMENTAL AND PYSICAL SPECIFICATIONS

Permissible environment conditions for operation: Temp. from +10 to +30°C.
Humidity from 15% to 85% - no dew
Permissible environment conditions for transportation
and storage: Temp. from -20 to +65°C.
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OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
Humidity from 5% to 95% - no dew

Size and weight: Width: 320 mm
Depth: 560 mm
Height: 580 mm
Weight: 23,2 Kg
ELECTRICAL SPECIFICATIONS
Voltage: 230 Vac ± 10% or Power cons: 100 VA, about 56W
115 Vac ± 10% selectable with voltage selector Switch on cons:225 VA, about 135 W
Frequency: 50 or 60 Hz ± 2 Hz
Classification: Class I (EN61010-1 – IEC 1010-1 – CEI 66-5)
OTHER OPERATIVE SPECIFICATIONS:
Heat dissipation in the environment: about 190 BTU/hour Noise: 54,0 dB(A)
Maximum rated altitude: 3000 mt asl
Communication: 2 serial RS232 DB 25 ports located on the rear side of the instrument:
Port 1 is dedicated to connect an external scanner
Port 2 is dedicated to connect the instrument to an Host Computer
Functioning: The instrument is designed to remain switched ON 24 hours a day, it is
however suggested to switch it off at the end of the working day, applying
previously a washing procedure using 3 washing tube to ensure a long
capillary’s and sensors’ life.
Restrictions: Indoor user appliance
Rated pollution degree: Grade 2
Working life of the instrument: 10 years (if maintenance is done correctly)
CONSUMABLES
Printer Paper: Thermal roller 57 mm x 25 meters (code SI19580001 4 rolls)
Smart Card: Conform to ISO 7816-1 specifications - 85.6 x 54 x 0.8 mm
Coded using SIRE Analytical Systems / Alifax Group proprietary algorithm.
Available for 1,000 (Ord. code SI 195.901) - 4,000 (Ord. code SI 195.904) - 10,000 (Ord.
code SI 195.910) - 20,000 (Ord. code SI 195.920) tests / Universal Card for TEST1 family
analyzers (TEST1; MicroTEST1; Roller 10; Roller 20).
Waste Tank: 250 ml plastic waste tank with screw cap (code SI10280101)
INTERNAL QUALITY CONTROL

TEST1 Family Quality Control: it is a software (code SI19562001) designed to collect and process the data
from one or more TEST1 family analyzers (TEST1, MicroTEST1, ROLLER 10,
ROLLER 20) for evaluating their performances.
Latex Controls: Latex Controls for TEST1 family analyzers allow the control of the calibration
stability of TEST1, MicroTEST1; ROLLER 10 and ROLLER 20. They are
available in two kinds of test tubes:
♦ 13x75 mm Greiner: Latex Controls (6 tests) - code SI 305.100-A;
Latex Controls (30 tests) – code SI 305.300-A
♦ 11,5x66 mm Sarstedt: Latex Controls (6 tests) - code SI 305.102-A;
Latex Controls (30 tests) - code SI 305.302-A
VARIOUS / OTHER FEATURES
Patient identification: External CCD bar-code reader (SI19582001).
Common features: - New design with thermoplastic cover, front door for an easier access to waste tank
and to the needle.
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OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
- Simplified-needle replacing procedure with magnetic unlocking and screw needle

- Automatic rotation of the wheel during the test-tube insertion / removal.
- Automatic priming at the end of the mixing cycle.
- Simplified Smart Card downloading using a single operation.
- Automatic washing if no blood flux is detected after three successive test-tubes.
- Automatic washing at the end the analysis cycle (programmable from 0 to 99
minutes).
- Photometer check at the end of each washing to ensure continuous control of
instrument.
- Management of Latex Controls Kit for TEST1 family analyzers SI 305.100-A/SI
305.102-A (6 tests) – SI 305.300-A/SI 305.302-A (30 tests) for the control of the
calibration stability of the instrument.
REFERENCES:
(1) Micoli M. et All. Lab. Analisi Chimico-Cliniche ed Ematologiche Osp. Civile Verona: “Roller T1: Una nuova generazione
di analizzatori per la Velocità di Eritrosedimentazione” , Biochimica Clinica, 2004, Vol 28, pg 203
1 1 1 2 3 1
(2) Kagawa Yuko , Nobuko Ikeda , Shingo Ito , Makino Sahei , Miyake Noriko : Clinical Test Section of Eiju Hospital ,
2 3
Finggal Link Co. Ltd , Dept. of Clinical Pathology of Juntendo Univeristy : “Evaluation for ESR automated measuring
instrument with EDTA” 36th Japan Society for Clinical Laboratory Automation, 30 September 2004, Japan.
(3) E. Heverin (Galway-Mayo Institute of Technology, Ireland): ”Comparison of the Westergren method versus the TEST1
technique for determining the Erythrocyte Sedimentation Rate”, May 2002, private communication
(4) NCCLS “Reference and Selected procedure for the Erythrocyte Sedimentation rate (ESR) Test; Approved Standard-
Fourth Edition”, Vol. 20 No. 27
(5) Sox HC, Liang MH: “The Erythrocyte Sedimentation Rate”, Annals of Internal Medicine 1986; 105:515-523.
(6) NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology “Multiple Myeloma”
(V.I.2007)
(7) Ajubi et al.: “Determination of the lenght of sedimentation reaction in blood using the TEST1 system: comparison with
the Sedimatic 100 method, turbidimetric fibrinogen levels, and the influence of M-proteins”, Clin Chem Lab Med 2006;
44 (7): 904-906
(8) Mercurio S. et al.: “Comparison between two methods for ESR measure in patients affected by myeloma”, 37° SIBioC
National Congress, 11-14 October 2005 Rome.
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OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
3 WARNINGS TO ENSURE A CORRECT INSTRUMENT USE

 The manufacturer does not assume any responsibility for any damages to persons or things due to
improper use of the instrument, installation not in compliance with the manufacturer's specifications,
use of the instrument not in security, use of not suitable materials regarding those specified in the
user's manual, use of the instrument for various scopes different from those for which it has been
designed and built, use of the instrument by not expert staff person or however non-authorized to the
use of the instrument and/or in case the sanitization procedure will not be carried on if required.
 Be sure that the instrument is connected to an efficient ground before its use.
 Check the waste tank level before starting the measures. Empty or replace the waste tank, if filled to
security level; for the disposal of waste tank content, follow the standard safety procedures in use in the
laboratory.
 Switch the instrument on and wait for at least 20 minutes before its use to reach the thermal circuitry
equilibrium.
 Check if the tube contains at least 1 ml of blood and verify that the blood is neither haemolysed nor
coagulated. Use exclusively blood samples withdrawn in EDTA as anticoagulant (K2 or K3)
 Blood samples must remain capped. Don’t uncap and recap them because this could corrupt the
instrument performances.
 Use, preferably, tubes with a capacity of 3 ml verifying that the sample volume does not exceed the 50-
60% of the total volume of the test-tube to optimise the sample homogenisation. The use of test tubes
with different volumes/capacity might change the effect of the instrument performances.
 Start the analysis within 4-6 hours from venepuncture. Otherwise keep the samples in refrigerator at +
4÷8 °C for a maximum of 24 hours. If the samples have been conserved in refrigerator at + 4÷8 °C. it is
necessary to leave them at room temperature at least for 30 minutes before executing their analysis.
 Carry out the "WASHING PROCEDURE" with peculiarity in order to maintain the instrument efficient
along the working time.
 For professional in vitro medical diagnostic use only.
 The instrument is designed for indoor use only
 For your safety, if any parts are damaged, demand original spare parts, specially for the parts
connected to mains (power cord, fuse-holder and mains switch …), for the replace.
 The instrument, can be exposed to potentially infective materials, is therefore indispensable to adopt all
the precautions and warnings necessary apt to avoid the contact in accordance with national laws..
 Avoid the use of the instrument near electromagnetic sources like, for example, mobiles, CB’s, radio transmitting units
and similar.
 Battery for CPU S195.001C is Wentronic #23323 BH170-3P; Ni MH; 3,6V 230 mAh..
RISCHIO BIOLOGICO- USARE I GUANTI

BIOLOGICAL RISK - USE GLOVES
PERICOLO - NON TOCCARE LA PARTE ALTA

DEL PISTONE DURANTE IL CAMBIO AGO
DANGER- NEVER TOUCH THE UPPER AREA OF
PISTON DURING NEEDLE REPLACING
 If the instrument is new and it has been stored in cold places, before lighting it wait for at least 30
minutes in order to avoid any damages due to dew presence on internal parts.
 Keep away any kind of objects, liquids, or substances not required for the use of the instrument.
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OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
 Switch the instrument off before connecting external devices as External Bar Code Readers, printer
cables or RS232 serial cables.
 Use original spare parts only supplied from the manufacturer.
 Do not remove panels neither camper the reading sensor. The maintenance operations must be carried
out only by technical personnel authorized from the manufacturer.
 Prior to install and use the instrument for the first time, it is suggested an evaluation of the
electromagnetic environment
 Do not use the instrument in proximity of sources of strong electromagnetic radiations (e.g. mobiles,
CB’s, radio transmitting units and similar or unshielded intentional RF sources) as these may interfere
with the proper operation of the instrument
 In order to avoid possible mistakes in the Query-Host communication and/or the transmission of patient
ID to the Host computer, it is recommended the use of bar-code codification which includes the “check-
digit” option in its protocol.
 Battery for CPU S195.001C is Wentronic #23323 BH170-3P; Ni MH; 3,6V 230 mAh..
 Instrument is compliant with IEC 61326 emissions and immunity requirements
PROCEDURE OF INSTRUMENT WASTE AT THE END OF ITS OPERATIONAL LIFE
As stated on European directive 2002/ 96/CE on waste of electrical and electronic equipment (WEEE)
appropriate measures should be adopted to minimize the disposal as unsorted municipal waste and to
achieve a high level of separate collection of WEEE, according to the applicable local laws and rules.
The crossed-out wheeled bin symbol on side, placed also close to the plate of the apparatus, points out
the necessity of the separate collection of the electrical and electronic equipment (WEEE).
The separate collection of this instrument at the end of its life is organized and managed by your
distributor. The user who is going to get rid of it will therefore contact his distributor and follow the system
that he has adopted in order to dispose the separate collection of the equipment that has reached the end
of its working life.
The unauthorized disposal will be pursued according to the local laws and the rules in the nation of use.
Penalties will be effective, proportionate and dissuasive.
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Ed. 1 Rev.13 -2014, April, 05
4 UNPACKING AND INSTALLATION

Qualified for the installation personnel
To avoid the guarantee invalidation, the installation of this apparatus cannot be done by a final user, but it must
be done by a qualified technician being authorized from the manufacturer. In this way, any possible problem
that could jeopardize the work of the instrument or its results, can be evaluated and eventually resolved by
these trained people.
Packing control
The instrument comes packed in a carton box with wood socket. Before unpacking it, carry-out a pack
verification verifying if sides and corners of the box are damaged. Check the wood base also.
Any damage, has to be reported in the installation and Testing Form documentation available in
the instrument package.
Unpacking
Two people are required to unpack the instrument because the weight and the volume of the instrument don't
allow to be performed by a single person.
Open the pack from the top, extract the first box that contains the accessories and then the instrument from
sides using the cardboard tool that facilitates that work.
Place the instrument on the floor or on a low table to remove of the protective nylon foil easily.
Report any damage of instrument plastic covers on the Installation and Testing Form.
Packing control contents
Beyond the instrument, the pack contains a flat box with all the necessary accessories for a correct installation
of the instrument. All these accessories are listed on the Packing List form and they could vary according with
the instrument configuration.
The packing content and the accessories box must contain:
no. 01 ROLLER 20LC instrument.
no. 01 packing List form.
no. 01 installation and Testing form.
no. 01 declaration of CE conformity.
no. 01 final Testing certificate
no. 01 mains cable
no. 02 thermal paper rolls (one is installed, one is in the accessories box).
no. 02 waste tank (one is installed, one in the accessories box)
no. 02 mains fuses
Moreover, according to the configuration of the instrument, the following accessories may be found:
no. 01 external bar-code reader (EBCR)
Refer however to the Packing List form for the control of the packing and accessories box contents, signaling
any difference between the pack contents and those listed on the Packing List on the Installation and Testing
form. This will help us to guarantee better controls during manufacturing and packing.
Instrument installation
The instrument must be installed on a working table able to support its weight (about 40 Kg) and providing
enough space on the right side to reach the power supply switch, located on the back side of the instrument,
just above the mains cord.
Choose a location sheltered from direct sun light and far away from moisture fonts in order to allow accuracy
work and to increase the instrument working life.
Besides, provide at least 10 cm of clearance on the back side of the instrument to allow the connection of
the mains cable and data cable for the connection with the Laboratory Informative System (LIS).
Avoid connections to mains through plug adapters and choose an electrical outlet far from strong impulsive
voltages generated, usually, from centrifuges, refrigerators, elevators and freight elevators.
Before connecting the cable to mains outlet, make sure that the mains voltage selector, located on the back
side of the instrument and just above the mains power switch, corresponds to the supplied voltage. Details of it
are reported in the next page.
Moreover, before powering the instrument on, open the front flap and check if the waste tank has been put in its
location and if the terminal part of the capillary has been inserted in it.
Afterwards, light the instrument and check if MAIN MENU is displayed at the end of the initialization procedure.
Any possible anomaly must be signaled on the Installation and Testing form document.
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Ed. 1 Rev.13 -2014, April, 05
5 VOLTAGE SELECTOR AND FUSES REPLACEMENT

Before switching the instrument on for the first time, it is necessary to verify the position of the voltage selector
The factory sets the voltage to 230 Vac.
Locate the voltage selector on the rear side of the instrument, as displayed on the
photo, then by means of a small flat screwdriver, rotate
the selector toward right to set it to 115 Vac.
On the Main Switch block are located 2 fuses, which are easily accessible to be
replaced.
To replace the fuses use the following procedure:

• Locate the fuse box
• By a flat screwdriver, push down the small tongue that keeps the box inside
the switch block and pull it out using a small pliers (if necessary).
• Remove the fuse box

completely
• Change both fuses (*)
• Insert the fuse box inside the

Main Switch block again.
(*)
The fuse which is placed in appliance inlet should be replaced by T 2,5 A 250 V dimensions 5x20 mm for a
power of 230Vac and by T 3,5 A 250 V dimensions 5x20 mm for a power of 110Vac.
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6 SYRINGE CHOICE
ROLLER20LC is supplied normally with the CBC syringe designed to work with ordinary BC \ Greiner test
tubes.
It is possible, however, to require the analyser with installed other kind of syringe like for Sarstedt or Terumo
test tubes.
Photo 1 Photo 2 Photo 3
CBC syringe. Sarstedt syringe Terumo syringe

Code SI195.021 Code SI195.022 Code SI102M23
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7 KEYBOARD SPECIAL FUNCTIONS

The keyboard uses special keys that activate the choice.
The keys point out not only the numerical value but even the function that activates, if pressed.
The keys are:

0 - Availability Increase To Increase the availability of credits.
1 - Rack Insertion Used to start an analysis cycle.
2 - Washing To clean the needle and capillary
3 - Rack Removal To remove test tubes from the wheel.
4 - Date & Time
5 - Tech. Menu Described in the Technical Manual.
6 - Electronic calibration Used to run the instrument control by Latex.
7 - RX Data Waiting Not used
8 - Operat. Menu
9 - Tank Replace
REPRINT To activate the printing of the statistical data
PAUSE Reserved to technical service
MAIN MENU
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Ed. 1 Rev.13 -2014, April, 05
8 SWITCH the ANALYSER ON

Verify if the front door is closed and light the instrument pushing the switch set on the instrument rear side. Wait
at least 20 minutes before starting the analysis to allow the temperature to reach the 37° C stability.
The printer is going to printed out:
ROLLER 20
IT ver. 4.xx
UK ver. 6.51C Identification message of the installed software version

ROLLER 20 SN. xxx Instrument Serial Number
GG/MM/AAAA HH:MM Date & Time
======================
Availability
ESR 20000
A message as above is printing while the instrument generates two acoustic beeps.
All mechanical parts movements will be checked and the instrument initialized automatically.
After that, the printer is going to print out:
======================
8 - MENU
======================
TEMP. 37.0 Nominal temperature of work.
Any test tubes and washing tubes still in the wheel, must be removed at the automatic requesting time.
9 WASTE TANK LEVEL MESSAGE

An added function in the software, calculates the volume of liquid wasted into the waste tank after the analysis.
The number of analysis that can be processed without emptying the waste tank is fixed to 1000.
A counter is increased after each processed sample.
If the alarm threshold is reached, the following message will be printed-out while….
===============
Waste Level
detected
EMPTY the tank.
===============
… the yellow led set in the left side of the keypad is blinking and the display is showing the message like:
0 - NOT EMPTY 1) Open the front flap and empty or replace the tank.
1 - EMPTY 2) Press key "1" to turn the counter to 0
To disposal the waste tank content, follow the standard safety procedures the
laboratory works with.
Note:
1) If it is not necessary emptying or replacing the tank, press 0 to close the procedure without resetting the
counter.
2) Pressing key 9 at MAIN MENU it is possible recalling the displayed options as described above.
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10 MAIN MENU
MAIN MENU
choose
Pressing key 8 (Operat. Menu ), the display is going to show the following options:
1 - To print Menu
2 - To mix
Pressing key 1, the printer is going to print-out a list as below:
0- AVAILABILITY 0. Is to increase the availability of test

1- MEASURE 1. Is to start a new analysis cycle
2- WASHING 2. Is to start a new washing procedure
3- RACKS EXTRACTION 3. Is to remove test tubes from the instrument
4- DATE & TIME 4. Is to change Date & Time
5- TECHNICAL MENU 5. Is to access Technical Menu (the password is required)
6- CALIBRATION EC 6. Is to perform an instrument check by a Latex Control kit.
7- RS 232 RX DATA 7. No longer in use.
9- TO CHANGE TANK 9. Is to reset the alarm counter of the wasted liquid.
REP - STATISTICAL DATA REP. Is to prints out the statistical data
a- Latex Control trend plots
b- Blood trend plots
c- Cumulative average ESR.
d- Cumulative standard deviation.
e- ESR average of the working day.
f- Standard deviation of the working day.
g- Washing data
Pressing key 2, the mixing function is going to be activated.

The inserted samples will be mixed without analyzing them. Open the front door and insert the sample tubes
following the displayed instructions.
This function becomes useful if a hematology mixer is not available during the comparative proofs between the
instrument and the method used in the laboratory. The inserted samples are mixed by means of the same
number of rotations programmed for the analysis, and at the end they are kept mixed through a rotation on
each 10 seconds until ENTER key is pressed.
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11 TO CHANGE DATE & TIME

This procedure can be executed pressing key 4 – Date & Time from MAIN MENU
The following message will be shown:
DD/MM/YYYY where DD=Day, MM=month, YYYY=Year

setup DATE
If some digit has to be changed, press CLEAR and type the correct date. Press ENTER, then, to bypass the
time field. If time is correct, press ENTER key twice to go back MAIN MENU.
To change the time press ENTER from the date. At this point the displayed message is:
HH:MM where HH=hour, MM=minutes

setup TIME
If time is correct press ENTER key.

If some digit has to be changed, press CLEAR and type the correct TIME in whole time format.
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12 PAPER LOADING PROCESS INTO THE PRINTER

The described procedure has to be done at instrument ON.
1- Open the cover of the printer set above the keyboard and remove
the residual part of paper. If the printer model is “CUSTOM PLUS”
then to open the cover force the two lateral clips which retain it.
If the printer model is “CUSTOM PLUS II” then to open the cover
press the green central key.
2- Pull-out roughly 15cm of paper from the roll, remove the part stuck
on paper and be sure that the paper stream descends from the
bottom side of the roll.
3- Place the new roll into the printer lodgement with the paper border
Photo 4 CUSTOM PLUS
out from the printer.
4- Close the cover pressing it deeply until the two retaining clips are
locked to the printer.
5- Press PAPER FEED on keypad or on the printer to obtain

more paper if it is necessary.
Photo 5 CUSTOM PLUS II
Note:
If the paper roll is sold with the code 195.800, its exhaustion is indicated by a red colour line painted on the
last part of the strip. Please remember that from the initial appearance of colour the strip can guarantee
the printing of 60 samples and therefore it is suggested to replace the roll immediately after finishing the
analysis cycle or before starting a new one.
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13 SMART CARD TO INCREASE CREDITS

13.1 AVAILABILITY TEST INCREASING
The instrument works with credits of test which can be loaded by means of a Smart Card ALIFAX supplies.
The amount of credits the customer can require is between 1000, 4000, 10000, 20000.
By this software version, the Smart Card and process to load credits are managed by the instrument which
includes options printed-out on paper during the loading process activation.
If, on MAIN MENU, key 0 is pressed, the printer will be able to print-out a menu as reported below:
1 – increase AVAIL.
2 – smart status
3 – print log smart
To increase credits by ordinary Smart Card, press key 1, insert the card
into the reader slot and then press ENTER when “SM FST AREA OK” (the AVAILABILITY
ESR 1995
instrument’s personalization has been matched to the card personalization) New personalization
is displayed. The printer is going to print-out messages like those reported ALIFAX SPA
on the right. Remove the Card and press ENTER. SMVALUE 1000
To check the card press 2. The instrument displays the request to insert the card into the slot. Insert the card
and wait. The display will show information according to the Smart Card status. It could be :
…...if the card is already used. Remove the Used card

Used Card Sn 0
Press ENTER card and press ENTER while the printer is Contain xxxxxx tests
going to print-out the message like the one set Download date 31/03/2010
on the right..
……if the card is unused. Remove the card Not used card
Not used Card
Press ENTER and press ENTER while the printer is going to Sn 0
Contain xxxxxx tests
print-out the message like the one set on the Manufacturing year 2000
right.
To get the SMART CARD LOG press 3. The printer is going to print-out the history of all loadings been
executed; e.g:
----------LOG SMART CARD----------

Date Aut I Card Aut. A Sn Year
31/03/10 1995 1000 2995 0 2000
25/03/10 200 1000 1200 0 2000
31/03/10 1000 10000 11000 0 2000
Note:
When key 1 (Rack insertion ) is pressed and the present availability is between 0 and 1000, the request to
increase the availability will be recalled automatically.
If the availability is 0 or negative, the instrument will not allow the execution of new analysis; until new credits
are loaded.
13.2 UNIVERSAL CARD

Recently Alifax has introduced a new Smart Card which is an
evolution of the previous ones. It is designed to work with all ESR
line devices ALIFAX developed. The procedure to work with this
kind of card is similar than the previous ones and sale codes and
amount of credits stored is similar too.
Photo 6
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13.3 SMART CARD ERRORS

During the loading process, incorrect procedures or possible malfunctions can be caused by:
1. …the smart card not inserted properly or inserted upside-down
2. …the card contact plaque not set to the internal side of the instrument.
3. …the reader contacts don’t allow the card to be read.
Error messages could appear on display like:
OUT STD XXXX it means the card has a number of tests that is outside the
Press ENTER
normal ranges: 1000 – 4000 – 10000 – 20000
SM FST AREA NOK it means the inserted card has a personalization that doesn’t match the
Press ENTER
instrument personalization and so the instrument rejects that card.
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14 USE OF PAEDRIATIC TEST-TUBE

The insertion of pediatric test-tube in the wheel requires the use of adapter. The adapters Alifax can supply are
not universal but designed in three different measures for
SARSTEDT (Photo 7)
TAPVAL (Photo 8)
VACUTAINER (Photo 9)
The sale codes of the adapters are:
SI195595 (adapter for SARSTEDT test-tube)

SI195590 (adapter for TAPVAL test-tube)
SI195593 (adapter for VACUTAINER test-tube)
Photo 7 Photo 8 Photo 9
Note:
Other kind of pediatric test-tube cannot be used because of lack of adapter.
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15 TEST TUBES INSERTION READING THE ID CODE (by External Bar

Code Reader)
MAIN MENU Press key 1 which will activate: BCR, ENTER o

choose measure START
1. Open the front door.

2. By the External Bar Code Reader plugged to the “SERIAL PORT 1” plug, read the code of the label
applied on a patient test tube.
The confirmation to have accepted that specimen to carry out the analysis is given by the rotor
rotation. It rotates to the next position and wait for the sample tube insertion while the display shows
the following information…
yyyyyyyyyy yyyyyyyyyy = patient identify code (ID)
measure START X X = rotor position for the test tube insertion
…followed by this message after having inserted the test tube in the assigned location:
BCR, ENTER or
to end START
3. Read the successive code and follow the instructions from point 2.
The wheel accepts from 1 to 18 sample test tubes, then, at the end of the insertion, the analyser waits for the
START key pressure and after closing the door, the rotor is going to rotate in order to move the wheel to the
19th position.
The analyser waits for the first insertion of the two test tubes with contains distilled water inside.
The software is designed to activate their use at the end of the pre-set time to run an automatic washing.
At the requesting time: Ins. wash. n°1
i. Open the door and insert the first tube with distillate water into the 19th position.
ii. Press ENTER key and insert the second washing tube in the 20th position
iii. Press ENTER key again and close the door.
The mixing process is going to run automatically followed by the measuring phase.
Note:
The analyser requires these two test tubes:
1. at the first analysis cycle of a new day assuming the analyser has been turned off for the night.
2. at the first analysis cycle after turning the analyser off and then on.
3. at the first analysis cycle after an automatic washing executed.
The analyser does not require these two test tubes again whether:
1. the capillary is cleaned by a manual previous washing procedure.
2. a new analysis cycle is run before the end of the pre-set time calculated from the end of the analysis
cycle since water of these two inserted test tubes has not been aspirated.
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Extra NOTE
If the identity code label read by the scanner does not match with the displayed one (scanner error) it is
possible to erase the wrong code pressing CLEAR key and repeat the reading.
If an automatic washing is performed between the end of the analysis cycle and the beginning of the
successive one because the washing preset time is expired, at the successive analysis cycle the
washing tubes will be required again.
If the automatic washing is not activated between the end of the analysis cycle and the beginning of the
successive one, at the successive analysis cycle the washing tubes will not be required.
If the analyzer is switched off at the end of an analysis cycle and then on, at the successive analysis
cycle and at the end of the loading process of the sample test tubes, the two test tubes for wash will be
required. When the analyzer is off, in-fact, it loses all the information concerning the inserted test tubes.
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16 TEST TUBES INSERTION AFTER HOST INTERROGATION

1. Open the front door.

2. By the External Bar Code Reader plugged to the “SERIAL PORT 1” plug, read the code of the label
applied on a patient test tube.
If the instrument is connected to the informatics system, generally called LIS or HOST at every ID
code read, ROLLER 20 interrogates HOST to verify if that specimen has to be analyzed or not.
In the positive case, the rotor rotates to one position to allow the test tube insertion to the assigned
wheel position.
The display is going to show the following message
yyyyyyyyyy Note:
yyyyyyyyyy points out the patient code (ID).
Insert X
X identifies the rotor position for the test tube insertion.
Insert the test tube into the assigned location and repeat the procedure from point 2 for the
successive test tube.
For the negative case the rotor does not move. The instrument gives three acoustic beeps and the
following message displayed for two seconds…
Not request Note:

X This number identifies the wheel position for the sample tube
measure START X
insertion
…followed by
BCR, ENTER o
measure START
3. Discard that test tube and repeat the procedure from point 2 for the successive test tube.
If the patient ID read through the EBCR does not find its correspondence code in the patient list of
HOST, the instrument analyzes that specimen in any case.
The following information, therefore, will be displayed for a couple of seconds…
Not find Note:

X This number identifies the wheel position for the sample tube
measure START X
insertion
…followed by
BCR, ENTER o
measure START
Press ENTER to assign an auto-generated code and insert the test tube into the assigned location.
Repeat the procedure from point 2 for the successive test tube
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19th position. The analyser waits for the first insertion of the two test tubes with contains distilled water inside.
ii. Press ENTER key and insert the second washing tube into position 20th position
The mixing process is going to run followed by the measuring phase.
Note:
2. at the first analysis cycle after turning off and then on the analyser.
3. at the first analysis cycle after an automatic washing done
1. the capillary is cleaned by a previous manual washing procedure.
cycle since the water of these two test tubes has not been aspirated.
Extra NOTE
If the identity code label read by the scanner does not match with the displayed one (scanner error) it is
possible to erase the wrong code pressing CLEAR key and repeat the reading.
If an automatic washing is performed between the end of the analysis cycle and the beginning of the
successive one because the washing preset time is expired, at the successive analysis cycle the
washing tubes will be required again.
If the automatic washing is not activated between the end of the analysis cycle and the beginning of the
successive one, at the successive analysis cycle the washing tubes will not be required.
If the analyzer is switched off at the end of an analysis cycle and then on, at the successive analysis
cycle and at the end of the loading process of the sample test tubes, the two test tubes for wash will be
required. When the analyzer is off, in-fact, it loses all the information concerning the inserted test tubes.
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17 TEST TUBES INSERTION (MATCHED WITH PATIENT ID CODE TYPED

MANUALLY)

1. Open the front door

2. Type the specimen ID code from yyyyyyyyyy Note:
the numerical keys. If the typed yyyyyyyyyy points out the patient
code is incorrect, press CLEAR to measure START code (ID).
erase digit by digit and type the
right code .
3. Press ENTER to confirm.

The wheel is going to rotate to the next position to allow the test tube insertion
4. Insert the test tube into the yyyyyyyyyy Note:

assigned location yyyyyyyyyy points out the patient
Insert X code (ID).
X identifies the rotor position for
the test tube insertion.
5. Repeat this procedure from point 2 to 4, if others samples test tube have to be inserted.
ii. Press ENTER key and insert the second washing tube into the 20th position
Note:
cycle since the water of these two test tubes has not been aspirated.
The extra note is similar than on the previous cases as written on page 22
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18 TEST TUBES INSERTION (MATCHED WITH AUTOGENERATED ID CODE)

If a test tube contains blood of a patient but it is not marked by the patient ID code, the analyzer can assign one
progressive number by itself:

1. Open the front door
2. Press ENTER key yyyyyyyyyy Note:

yyyyyyyyyy points out the auto-
insert x generated patient code (ID).
X points out the rotor position for the
test tube insertion
The wheel is going to rotate to the next position to allow the test tube insertion.
3. Insert the test tube in the assigned location and repeat the procedure from point 2 to 3, if others
samples test tube have to be inserted.
ii. Press ENTER key and insert the second washing tube in position 20th position

cycle since water of these two test tubes has not been aspirated.
The extra note is similar than on the previous cases as written on page 23
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19 PRIMING PROCESS and MEASURING PHASE

“Priming” is a process which has the purpose to remove water particles from the capillary due to a previous
washing procedure done and to avoid diluting of blood in the reading cell at the first measuring phase.
The priming procedure consists in aspirating 87µl of blood from the 1st and then from the 2nd sample test tube
assuming at least two of them have been loaded in the wheel. If it has been inserted only one, the two aliquots
of blood of 87µl each are withdrawn from that test tube.
After loading the test tubes in the wheel and starting the analysis cycle, assuming the capillary has been
cleaned by a washing procedure executed previously, the analyzer splits up the time of the mixing process to
carry out priming. At the end of it and if the priming has been done unsuccessfully, a washing procedure will
start automatically aspirating water from the 19th and 20th inserted test tubes.
The instrument, then, is going to repeat the priming and if it is done successfully the analyzer is able to go
ahead executing the second half of mixing followed by the measuring phase. Otherwise if it is done
unsuccessfully the analyzer is going to activate and display the request of a new automatic washing.
ENTER Washing
CLEAR to end
Pressing ENTER, the wheel is going to rotate to the 19th position. It will require to remove the inserted test tube
in order to refill the position with a new test tube filled with distilled water. Upon inserted a new test tube into the
19th position and pressed ENTER again, the wheel is going to rotate to the 20th position for the second washing
test tube insertion. After inserting the second test tube, press ENTER and close the door. The rotor is going to
rotate again to run the new automatic washing procedure moving the wheel to the 19th position and then to the
20th.
All this processes will be repeated, until the priming is executed successfully; except when CLEAR key is
pressed.
The instrument is able to start mixing again followed by the measuring phase of each inserted sample test tube,
if the priming has been executed successfully.
If during the measuring phase the analyzer gives 3 consecutive “NF”, which means no blood flow, the
instrument will carry out a washing procedure automatically aspirating water from the 19th and 20th test tubes.
The mixing cycle will start again, for the washing done successfully, and then the instrument will jump the 3
sample tubes that have caused the malfunctioning.
Another “priming” process will be run again aspirating blood from the successive sample test tube and
eventually, with the priming done successfully, the cycle will go ahead without others requests.
Note:
If a sample tube falls down during the mixing cycle (the tube sensor checks if the samples are inserted) the
instrument gives an error message printing these result as CM.
The analytical cycle stops if 3 successive missed sample tubes will be detected.
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20 ESR RESULTS PRINTED OUT ON PAPER

For each analyzed specimen, the printed out results will have a format similar than:
Example of format with details printing option enabled:@
============================
Tube n° 1 04/11/2011 15:07:13
ID 847297429742
ESR 16
Tube n° 2 04/11/2011 15:07:31
ID 987892722244
ESR 2
Tube n° 3 04/11/2011 15:07:50
ID 654754626728
ESR 9
Tube n° 4 04/11/2011 15:08:08
ID 986348232467
ESR 30
============================
Example of format with printing details option disabled @
04/11/2011 15:07:13
============================
ID 847297429742 ESR 16
ID 987892722244 ESR 2
ID 654754626728 ESR 9
ID 986348232467 ESR 30
Example of possible results:
04/11/2011 15:07:13 An asterisk (*) printed-out next by the ESR result, points out that
============================ this particular sample has a low value of hematocrit (20 % roughly).
ID 986348232467 ESR 30 * CM (Sample missed) message can occurs when the syringe have not
ID 986255542424 ESR C.M. hit with the sample test tube. Probably dropped down during
mixing.
ID 986242242333 ESR NF
NF (No flow) message occurs when blood is not present in the
ID 234245646567 ESR NR reading cell at the measuring phase.
ID 242448482472 ESR <2 # NR (No reliable) message occurs when during the measuring phase
the red cells of the specimen cannot aggregate between them and
ID 343443232344 ESR >120# accordingly the result has not been calculated correctly.
============================ <2 This means the real ESR is lower than 2mm/h but since the
reading scale starts with 2mm/h, the instrument cannot prints out a
value lower than 2.
>120 This means the real ESR is higher than 120mm/h but since the
reading scale ends with 120mm/h, the instrument can prints out
instrument cannot prints out a value higher than 120.
@ Note: To enable or disable the details printing call the technical service.
# Note: To be printed out, the limits (<>) have to be enabled in the appropriate field available in the
technical menu. To do that call the technical service.
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21 RESULTS REPRINTING
At the end of the analysis cycle the instrument is going to generate acoustic beeps while the following message
displays:
1- REPRINT 1= it reprints detailed information of all the analysed specimens.

2= it reprints the patient ID code matched with the ESR result only of
2- REPRINT ESR
all the analysed specimens.
followed by
3- SEND TO HOST 3= it sends the result string of all the analysed specimens to host
computer.
ENTER EXIT ENTER= is to exit from the analysis cycle. The test tubes extraction will
be required before going back to MAIN MENU.
Note:
The REPRINT options are displayed consecutively and in loop.
22 TEST TUBES EXTRACTION

After turning the analyser on and the initialization phase, the wheel is going to rotate to all positions, one by one
automatically, in order to identify if test tubes are still inserted in it. If it identifies a test tube, the display will
point-out it. Open the front door and remove it from the wheel. The wheel, then, is going to rotate to find out an
hypothetic successive test tube automatically.
If the analyser is on MAIN MENU, any test tube still present in the wheel can be removed, with the exception of
the two inserted for the automatic washing assuming these were not been used yet, pressing key 3 (Rack
Removal).
The LCD display shows this message:
wait
positioning
and after a few seconds
Extract
CLEAR to end
Open the front door and one by one extract the inserted test tubes and close the door.
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23 MANUAL WASHING PROCEDURE

This procedure is designed to clean the complete capillary tubing and so to set it free from blood or Latex
residuals.
Since along the working life, blood, water and latex flow inside the Teflon capillary tube, particles of them tend
to hang on the internal walls of it. This fact, accordingly, increases the capillary opacity reducing the reading
scale of the ESR values.
In order to maintain the capillary cleaned and to increase its own working life, the operator should carry-out
washings in different ways as described below:
23.1 WASHING USING 2 TEST TUBES

Despite the software has been designed to activate automatic washings, the user can carry out washings
manually. But, while for the automatic washing, which is activated at the end of the pre-set time, it is required
two test tubes filled for ¾ with distilled water and put in the 19th and 20th position of the wheel, the manual
washing foresees two test tubes filled for ¾ with distilled water too but put in the 1st and 2nd position.
Press key 2 (Washing) on MAIN MENU, open the door and then insert the 1st test tube in the first position of
the wheel and press ENTER, insert the 2nd to the second position and press ENTER twice. Close the door and
wait for the end of this process.
23.2 WASHING USING 3 TEST TUBES

At the end of the working day, the execution of this option has the purpose to maintain the needle and
capillary cleaned during the night and any residual of blood particles wet increasing, therefore, the capillary
working life. The residuals will be removed easily at the beginning of the new day.
To activate the procedure, it is required 3 test tubes filled for ¾ with distilled water. They have to be inserted in
the first three positions of the wheel after pressing key 2 (Washing) from MAIN MENU.
The needle will aspirate the content from the first and second test-tubes completely and partially from the third
test-tube remaining inside it while the analyzer is displaying the message “ROLLER20 off – ENTER continue”.
The user can chose to continue with the ordinary activities pressing “ENTER” or to switch the instrument off.
After switching on the instrument which should be at the beginning of the new working day, the needle is going
to exit from the third test-tube and the pump is going to rotate to empty the needle and capillary. Water and any
wet residual particles of blood will be discarded into the waste tank.
23.3 WASHING PROCEDURE FOR MAINTENANCE (useful even to unlock the needle and capillary )
For a good maintenance of the instrument and in case the needle and/or capillary are obstructed, carry-out this
procedure using distilled water and Sodium Hypochlorite (5% of dilution).
The frequency of use can be calculated according with the number of analyzed specimens.
E.g. once per 2 weeks up to 60 specimens per day
once per 1 weeks for over 60 specimens per day
The procedure is:
1. Prepare two test-tubes filled 3/4 with distilled water and press key 2 (Washing) to start. Put them in the
1st and 2nd position of the wheel and wait for the end of the procedure.
2. Prepare one test-tubes filled 3/4 with Sodium Hypochlorite (5% of dilution) and one test tube filled 3/4
with distillate water. Press key 2 (Washing) to start and put the 1st test tube into the 1st position of the
wheel and the 2nd test tube in the 2nd position.
Close the door and wait for the end of the procedure.
3. In order to rinse the capillary, prepare two test-tubes filled 3/4 with distilled water and press key 2
(Washing) to start again. Put the test tubes in the 1st and 2nd position of the wheel, close the door and
wait for the end of the procedure.
23.4 WASHING PROCEDURE IN CASE OF DAILY CONTROLS BY MEANS OF LATEX

KIT
The washing procedure in case of daily controls by means of Latex kit is the same of the previous described
procedure (washing procedure for maintenance). It has to be used every time before starting the control
process in order to carry-out quality control of the instrument (QC).
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At the end of each washing procedure, the software is going to report its value matched with the suffix T100.
E.g.
=========================
T. 100 (3503) Previous washing procedure value.
MAX Sens. 3574 T100 3503 pt Water value read from test-tube no.1 and former maximum reading
MAX Sens. 3574 T100 3503 pt sensitivity.
Ch2 S1 3574 S2 3574 Water value read from test-tube no.2 and former maximum reading
sensitivity.
14/11/2005
=========================
1 3574 2 3574
Washing executed
Wt 3574
*** PHOTOMETER OK *** Read values report from the first and second tube.
At every incorrect washing procedure, the printed-out result will be 2048 and the software will generate Z error.
A new washing procedure will be requested.
If the T. 100 fields reports a value of 2960 roughly, it means that the tubing is going to be opaque.
In this case try to carry-out the WASHING PROCEDURE FOR MAINTENANCE in order to reduce the opacity
of the capillary. The value then should increase to 3505.
If it remains closed to 2960, the technical service should be called in order to replace the complete tubing.
Note:
T. 100 value is reported on flag list which can be obtained in this way:
1. turn the instrument on
2. within two seconds after hearing two beeps sounds, press REPRINT key
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24 LATEX FOR QUALITY CONTROL PRESENTATION.

24.1 QUALITY CHECK USING LATEX CONTROL KIT
Latex Controls kit (sale code SI 305.100-A for 6 Controls or SI 305.300-A for 30 Controls) is a valid tool to
verify the analyser functioning and so to keep it monitored during its whole working life.
Before starting the Control process, the analyser can require a washing procedure. In this case, the
operator should carry-out the washing procedure as the instruction at MANUAL WASHING PROCEDURE
chapter explains. At the end of the Control process, the printed out results are three ESR values: the first
one is closed to 9 mm/h roughly, the intermediate one is closed 20 mm/h roughly and a high level is closed
to 60mm/h. The obtained results should be compared with the values reported on the label, second table
applied on the kit package. If the obtained results are into to the expected ranges, it means that the
analyser is calibrated correctly. On the contrary, if one or more results are out of the expected ranges, it is
recommended to call the Technical Service for a functional verification and calibration of the analyser.
At the Control process time, if the external scanner is able to read all three Latex codes, then the mixing
process will start automatically. At the same time the read codes will be stored into the chip memory of the
analyser. The read codes, then, are maintained stored in it until the number of the executed Controls is
over the scheduled ones. At the successive attempt to carry-out a new Control process, the instrument is
going to empty the test-tubes completely discarding the residual amount of Latex still present into them. By
this way, Alifax can guarantee the quality of the product to a maximum of 6 Controls and to a maximum
time of 6 weeks from the first Latex aspiration.
To run a Control procedure:
(1) Carry-out a washing procedure:
a. Execute a first washing procedure (press key 2 at MAIN MENU) using 2 test tubes filled for ¾ with
distilled water. The tubes have to be loaded into the position 1 and 2 of the wheel.
b. Execute a second washing procedure (press key 2 at MAIN MENU) using one test tube filled for ¾
with Sodium Hypochlorite and one test tube filled for ¾ with distilled water. The first test tube has
to be loaded into the position 1 of the wheel, the second into the position 2 of it.
(2) Verify that the analyser is on Main Menu, with the following message on display:
MAIN MENU
choose
(3) To start the Latex Control procedure press key 6 (Electronic Calibration). If the instrument needs a
washing again, the following message is displayed…
Make a Washing Follow the instructions described above at point (1) “a”.
…otherwise, or when the washing is completed, the following message is displayed.
1 -STD Procedure
2 Change STD
(4) Press key 1 to start, open the door and insert one test tube containing at least 3 ml of distilled water
into the first position of the wheel. Press ENTER so that the wheel is going to rotate to the second
position.
(5) By the external scanner, read the label of the first Latex test tube marked as number 2, insert the test
tube into the second position of the wheel and press ENTER.
(6) Repeat the same process for inserting the second and third Latex test tubes and marked respectively 3
and 4 into the 3rd and 4th positions of the wheel, pressing ENTER after each inserted tube.
(7) Insert the remaining two test tubes containing at least 3 ml of distilled water into the positions 5th and 6th
of the wheel pressing ENTER after each inserted tube.
(8) Close the door.
The analyser is going to start mixing which takes about one minute and half to be completed.
MIXING Note: if instead of mixing appears the message “STD N X xxxx” it
means that the scanner have not read the code of one or more test-
tubes. In this case, type the code as described in the next chapter.
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At the end of mixing, the needle is going to aspirate water from the first test tube and then a little amount of
Latex from the second in order to carry out priming. After priming done successfully, the analyser is going
to aspirate Latex again from the same test tube and then from the others two for the analysis process.
Afterwards the analyser is going to aspirate water from the successive last two test tubes in order to rinse
the capillary.
During the water and Latex aspiration the display shows some messages like those reported below as
example:
A 1023 B 960 related to the first washing
T100 3529
MEASURE wait appears during the latex analysis
A 1023 B 960 is related to the last tubes of washing

T100 3529
At the end of the aspiration of the last test tube, the printer is going to print out the latex analysis report.
An example is reported just below:
Message Meaning Notes
1543 921507 First Latex test tube marked n°2
0921 921507 Second Latex test tube marked n°3
0566 921507 Third Latex test tube marked n°4
Lot n° 1921 KIT 507 Lot and kit number
========================
Date and time of the washings process
10/11/2011 11:03:12
aspirating water from the first test tube.
Washing Executed
They are printed out together with the
========================
message that confirms the correct
*** PHOTOMETER OK ***
functioning of the photometer.
========================
FDF 0,9909 Water compensator value
========================
10/11/2011 11:04:47 Date and time of the washings process
Washing Executed aspirating water from the fifth test tube.
======================== They are printed out together with the
*** PHOTOMETER OK *** message that confirms the correct
======================== functioning of the photometer.
FDF 0,9920 Water compensator value.
========================
Reference values The printed values are the same The results of latex controls
LEVEL 2 = 10 ( 7 : 13) reported on the label of the box as must be within the range
LEVEL 3 = 27 (22 : 32) reference on the Latex Control kit. pointed out from the printing.
LEVEL 4 = 80 (69 : 82) This range is also reported in
========================= Table 2 on the kit package.
Photometer Param. They are the following: The controls results
ESR LEVEL 2
ROLLER 20  Type of the instrument
ESR LEVEL 3
UK ver. 6.51C  Software version ESR LEVEL 4
ROLLER20 SN. 1640  Serial Number (SN.) should be compared with the
FDF 0,9920 T100 3618  Water compensator and values reference values of the first
BoosterY 1.0704 MFACT 1.0704  Gains value printing (reference values).
Offset channel 125  Offset value.
========================== The reference values could
ESR LEVEL 2 = 10  The final values given from latex vary from Lot to Lot: refer to
ESR LEVEL 3 = 26 controls, which should stay within the the instructions of use
ESR LEVEL 4 = 79 ranges of the reference values. inserted in the kit.
==========================
When the analysis is completed, we have:

Extract Open the loading door and remove the test tubes one by one or press
CLEAR to exit without removing them.
CLEAR to end
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24.2 RECALLED LATEX ID CODE

During the second or one of the remaining four Latex Control processes, if the scanner cannot read one or more of the
three codes, the user could choose to recall the code stored at the first Control process of that kit assuming the lot
number is not expired.
E.g.
At display Insert value press ENTER basically and the stored
STD N 2 code will be confirmed automatically. Memo xxxx xxxxxx
Insert the test tube and press ENTER

24.3 LATEX CODES TYPED MANUALLY

At the first use of a new kit and if the analyser is not equipped with an external scanner or the scanner cannot read
one or more of the three codes, maybe the label is ruined, each Latex code could be typed manually before the mixing
process:
At display Insert value press ENTER, CLEAR and type the complete code number reported on
STD N 2 the label, glued on the test tube marked as 2.
Press ENTER, insert the test tube in the assigned wheel location and press ENTER again.
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25 QUALITY CONTROL TOOLS PRESENTATION

In order to carry out internal Quality Control, the ROLLER 20LC software includes a series of tools which report
and plot the instrument performances.
Such control tools are the following:
1. INSTRUMENT QUALITY CONTROL USING LATEX CONTROL KIT:

These plots come from Latex kit (code SI 305.100 for 6 tests or code SI 305.300 for 30 test) designed
expressly for the TEST1 family analysers (TEST1, Roller10-20PN, Roller20LC).
2. HEMATIC STATISTICAL DATA PRINTOUT. The graph, which takes into account the population who
refer to the lab, is generated by black and white circles which represent the cumulative and daily
averages of the ESR results.
At the beginning of the instrument working life, the Quality Control system stores values, represented
by the circles on the graph, of specimens analysed during the last 30 days.
Subsequently, the complete plot will be updated automatically.
3. ESR VALUES DISTRIBUTION PRINTOUT

There are four different plots divided in different ranges:
two of them points out ESR results from 2 to 120 mm/h (cover the complete range) and the other two
points out ESR results from 2 to 30 mm/h which in Italy they are considered not pathologic results.
This tool is useful to each lab to define a referent cut-off and split-up pathologic results from the no
pathologic ones.
4. WATER DATA PRINTOUT

By a black point for each day, this wants to report the daily average of the photometrical check done
during each washing procedure.
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25.1 QUALITY CONTROL BY MEANS OF LATEX CONTROL KIT

At the end of each Latex Control process, each obtained result could be represented into a Quality Control
plot trough black circles. The printer, therefore, can print out it for a statistic analysis.
After pressing REPRINT key from "Main Menu", the following message is going to be displayed:
STATISTICAL DATA Press key 1, to display the next message:

ESR STD RATE (1)
1 - TREND ESR Press key 1 (TREND ESR) to print out the following graph
2 - TREND FACT Press key 2 (TREND FACT) to print out the successive graph:
2 40 80 120 This graph shows the trend of the three Latex Controls
ESR values which checks have been performed along the
working days. The first series of symbols (* ° o) lined up on
∗ ο 0 the top line, represents the first analysis of Latex Controls,
∗ ο 0 while the last one on the line at the bottom represents the
∗ ο 0 results of the last check done.
∗
ο 0 Thought this graph it is possible to see the variations in trend
∗ ο 0 of the analyser that can be assessed in qualitative but not in
quantitative way.
∗ ο 0 Furthermore, in case of lot change, if the new lot is
∗ ο 0 characterised by different values from the previous one, the
∗ ο 0 obtained results will appear shifted on the graph, like the 1st
∗ ο 0 four series of symbols in the aside example.
∗ ο 0 In this case, it is suggested to monitor the trend of the new
Latex Control lot for few days and to verify the consistency
of the results obtained compared to the first reading without
comparing them to the previous lot.
Explanation:
-20 -10 1 +10 +20 During the calibration process by Latex, the software
DEV% identifies and stores the necessary gain called ModelFact to
obtain the expected ESR Latex results. That gain is
∗ represented by the vertical axis marked number 1 (see the
∗ graph). At every Control procedure, the operator does for
∗ Quality Control, the system calculates a hypothetic
difference of gain between the referent gain, of the vertical
∗ line marked 1, and the gain calculated during the process. It
∗ will not be stored but the gap value will be pointed-out inside
∗ the range of the graph by a black circle or * as in the
∗ example on the left.
∗ If the identified gain is the same as the referent ones (that it
is the ideal case), there is not a gap and the point will be
∗ printed-out exactly over axis 1. Beneath the graph, the
∗ Standard Deviation (Dev. St.) and the Percentage
∗ Coefficient of Variation (CV%) of the results are reported to
know whether the analyser works efficiently. In fact, if the
DEV. ST. 16,15 CV% remains under +/- 10% it means that the analyser
CV% = 8,05 works efficiently but if the CV% exceeds this limit, a revision
of the analyser calibration by the technical service is
recommended.
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25.2 HEMATIC STATISTICAL DATA PRINTOUT

The internal Quality Control program prints out the statistical data relative to the analysis gathered day by
day and those relative to results cumulated from the beginning of the instrument working life. This option
can be considered as an analytical control based on the “population of samples”, and assumes the
role of instrument check. If the analytical performances of the instrument is reliable and if we take into
account a sufficient high number of samples, (6000 roughly) the ESR mean value should not oscillate by
means of a significant manner.
Press REPRINT key on MAIN MENU to access into Q.C.

After displaying a first option this message comes in streaming:
STATISTICAL DATA Press key 2 to activate the printout of the graph which represents
M. (2) Sp. (3) W (4) the behaviour of the ESR mean values.
Printout of ESR MEAN value in the FULL RANGE (2-120 mm/hr)
(1-1) Samp. n. ww Where:

5 15 25
├───┴───┴───┴───┴───┤ ww = represents the number of samples considered
xx.xx ● (ESR range 2-120 mm/hr)
yy.yy ○
xx.xx ● xx.xx = represents the cumulative mean ESR value
yy.yy ○
xx.xx ● yy.yy = represents the ESR daily mean value
yy.yy ○
… zz.zz = standard deviation of cumulative mean ESR value
…
… vv.vv = standard deviation of daily mean ESR value
xx.xx ●
yy.yy ○ cc.c = CV% of the cumulative mean ESR value
xx.xx ●
yy.yy ○ kkkk = total samples processed
xx.xx ●
yy.yy ○
STD ● zz.zz kkkk

STD ○ vv.vv kkkk
CV% ● cc.c
A representative of patient population referring to the same lab, should generate a constant ESR mean
value. This is particularly significant increasing the daily analysis.
If whole data are taken into account from the first installation, it can be deduced that the mean value for all
these samples tends to reach its final stable point when more samples are cumulated, thus giving a
reference final value for that population (cumulative mean ESR value).
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Comparing the daily mean ESR value of all patients with the cumulative mean ESR value, the reliability of
the instrument can be evaluated.
What we can expect, is that the daily mean ESR value oscillates around the more stable cumulative mean
ESR value, which represents the reference.
The graphic plot can be used to see any systematic drifts from the cumulative mean ESR value. In this
case the instrument reliability can be suspected.
Printout of ESR MEAN value in the NORMAL RANGE (2-30 mm/hr)
(1-2) Samp. n. ww Where:
5 15 ww = represents the number of samples falling in

25 the ESR range 2-30 mm/hr
├───┴───┴───┴───┴───┤
xx.xx ● xx.xx = represents the cumulative mean ESR value
yy.yy ○ for samples within the range 2-30 mm/hr
xx.xx ●
yy.yy ○ yy.yy = represents the ESR daily mean value for
xx.xx ● samples falling within the range 2-30 mm/hr
yy.yy ○
xx.xx ● zz.zz = standard deviation of cumulative mean ESR value
yy.yy ○
… vv.vv = standard deviation of daily mean ESR value
…
… cc.c = CV% of the cumulative mean ESR value
xx.xx ●
yy.yy ○ kkkk = total samples processed
xx.xx ●
yy.yy ○ > min = min limit to be compared with the daily mean
(= cumulative mean - 3 x STD of cumulative)
Samples kkkk
STD ● zz.zz >min < max < max = max limit to be compared with the daily mean
STD ○ vv.vv (= cumulative mean + 3 x STD of cumulative)
CV% ○ cc.c
What is reported in the previous pages, is more significant for the “ normal population”,
In fact, the stability in time of the mean value of “normal population” is not effected by the percentage of
pathological samples that can vary from day to day, influencing the variation of the Mean ESR value.
Normal population of today and normal population of tomorrow will have distribution and mean ESR value
very close.
The “normal population“ is also , generally, the majority of population.
The control of the trend with time, comparing the standard deviation of daily mean ESR value for normal
range with the cumulative mean ESR value for normal range, can point out any systemic drifts of the
instrument.
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EXAMPLE1:
(1-1) Samp. n. 3744 (this is the stored number of samples)
19 29 39
|-----|-----|-----|-----|-----|
30.71 ● the black circle is the cumulative average
31.42 o the white circle is the daily average of first day
30.26 ● cumulative average (day 1 + day 2)
26.38 o daily average of second day
29.78 ● cumulative average (day 1 + day 2 + day 3)
25.19 o daily average for third day
……. …… ……………
This graph represents the last 30 days of analysis, and points out an anomalous
tendency of daily averages respect the cumulative average. This can alert the user for a
possible systemic error but the operator should take into account especially the
cumulative average trend. The data are shown from the oldest (on the top) to the most
recent (on bottom of graph).
The cumulative average line becomes stable after 100 samples stored and the daily
average moves around the cumulative trend line. In this way a problem on instrument
could be pointed out immediately by a rapid deflection of the daily trend line and
cumulative averages.
The instrument is able to collect 5900 samples for calculate the average, so also large
variations on daily statistics will not change in determinant way the cumulative average.
On the opposite side, as soon as it reaches 5900 samples, it will discard the first 1000,
coming back to 4900 samples to avoid that the cumulative average trend becomes too
stable to be moved.
At the end of the graph, the Standard Deviations of cumulative average and daily
average are printed:
STD ● 0.30 30 Standard Deviation for cumulative data (last 30 days)
STD o 4.33 30 Standard Deviation for daily average (last 30 days)
From a statistical point of view, a data can be considered stable if it stays between three
Standard Deviations of the reference population.
In this case, taking the last cumulative average data (29.17) and the three standard
deviations of the daily average (4.33 x 3 = 12.99), we can say that the last daily average
is in range if don't exceed the three standard deviations of the cumulative data.
In this example, the lower limit is: 29.17 - 12.99 = 16.18 and the upper limit 29.17 +
12.99 = 42.16. In this case, the daily value 26.54 enters inside between the two lower
and upper limits, so the instrument is working properly.
Remember that if this doesn't happen, the cause should be searched on the processed
samples during the day and from the kind of patients analysed (a lot of pathological or a
lot of healthy patients). This first graph is referred to all the ESR results from 2 to 120,
and this data can be highly instable. For this reason, also the next graph is printed out.
Number of days in the printout.
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EXAMPLE 2:
This second graph seems identical to the previous, but in this case the range is limited
to ESR results from 2 to 30.
This graph has the cumulative data more stable because specimens not affected with
pathological diseases.
In this case, the considered specimens are less (2351 vs. 3744 ) than those represented
in the previous graph, and this is logical because the no pathologic values in Italy are
surrounded from 2mm/h to 30mm/h.
As on previous case, we can analyse the meaning of this graph and the
results in terms of stability.
(1-2) Samp. n. 2351 (this is the total number of samples processed)
5 15 25
|-----|-----|-----|-----|-----|
13.47 ● the black circle is the cumulative average
13.85 o the white circle is the daily average of first day
13.48 ● cumulative average (day 1 + day 2)
13.53 o daily average of second day
13.57 ● cumulative average (day 1 + day 2 + day 3)
14.26 o daily average for third day
……. …… ……………
As on previous example, at the end of the graph, the Standard Deviations of cumulative
average and daily average are displayed:
STD ● 0.09 Standard Deviation for cumulative data

STD o 1.43 Standard Deviation for daily average
As on previous case, from a statistical point of view, a date can be considered stable if
stays inside three Standard Deviations of the reference population.
Also in this case, taking the last cumulative average data (13.53) and the three standard
deviations of the daily average (1.43 x 3 = 4.29), we can say that the daily average is in
range if don't exceeds the three deviations of the cumulative data.
In this example, 13.53 - 4.29 = 9.24 is the lowest limit and 13.53 + 4.29 = 17.82 is the
upper limit.
Looking at the daily value, 13.21 enter perfectly between the two limits calculated, so
the instrument can still be considered as just calibrated.
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25.3 DISTRIBUTION PRINTOUT

The ESR value distribution which values come from the population who refers to the same laboratory,
especially the distribution which ESR values fall down into the no pathologic range, can be assumed to be
a constant in time..
This variation can be due to a variation in the number of pathological samples coming from particular
wards. Keeping into account the daily ESR values distribution, it can be easily seen that the medium to
high values distribution can be varied, while the distribution within the normal range remains constant.
This observation guarantees that the instrument is working properly and the variation in the daily ESR
mean value can be attributed to a different composition of the population referring to the laboratory. As a
general rule, the higher the samples number is, the lower the variations compared to the cumulative
parameters.
ESR VALUES CUMULATIVE AND DAILY DISTRIBUTION PRINTOUT

Press REPRINT key on MAIN MENU to activate the statistical data printout procedure.
STATISTICAL DATA Press key 3 to activate the following sub menu.

M. (2) Sp. (3) W (4)
STATISTICAL DATA Press key 1 to activate the cumulative ESR distribution printout
represented by (2 -1) (2 -2) tables.
S. (1) D. (2)
Press key 2 to activate the daily ESR distributions printout
represented by (3 -1) (3 -2) tables.
It works in the range 2-120 mm/hr (step 5 mm/hr)

(2 -1) Samp. n. ww Where:
Av. xx.xx Std yy.yy ww = represents the number of samples considered

============================== in the ESR range 2 - 120 mm/hr
1 - 5 zz.zz nn xx.xx = represents the mean ESR value of the
6 - 10 zz.zz nn samples
11 - 15 zz.zz nn yy.yy = represents the standard deviation
…
… zz.zz = represents the distribution percentage in the
… considered range step, respect to the total
106 - 110 zz.zz nn range 2-120 mm/hr
111 - 115 zz.zz nn nn = represents the number of samples in the
116 - 120 zz.zz nn considered range, respect to the total number
of samples in the range 2 - 120 mm/hr
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It works in the range 2-30 mm/hr (step of 2 mm/hr).

Av. xx.xx Std yy.yy ww = represents the number of samples considered

============================== in the ESR range 2-30 mm/hr
5 - 6 zz.zz nn yy.yy = represents the standard deviation
…
25 - 26 zz.zz nn range 2-30 mm/hr
of samples in the range 2-30 mm/hr
Norm. jj.jj % jj.jj = represents the percentage of values in the
range 2-30 mm/hr, respect to the total number
of samples

Av. xx.xx Std yy.yy ww = represents the number of samples

=============================== considered in the ESR range 2-120 mm/hr
11- 15 zz.zz nn yy.yy = represents the standard deviation
… range 2-120 mm/hr
116- 120 zz.zz nn of samples in the range 2-120 mm/hr

ww = represents the number of samples
Av. xx.xx Std yy.yy
considered in the ESR range 2-30 mm/hr
===============================
xx.xx = represents the mean ESR value of the
1 - 2 zz.zz nn
samples
3 - 4 zz.zz nn
yy.yy = represents the standard deviation
5 - 6 zz.zz nn
zz.zz = represents the distribution percentage in the
…
considered range step, respect to the total
…
range 2-30 mm/hr
…
nn = represents the number of samples in the
25 - 26 zz.zz nn
considered range, respect to the total number
27 - 28 zz.zz nn
of samples in the range 2-120 mm/hr
29 - 30 zz.zz nn
jj.jj = represents the percentage of values in the
range 2-30 mm/hr, respect to the total number
Norm. jj.jj
of samples
The percentage distribution of ESR values is a further control of “constancy of population”. This control
is complementary to the previous control base on the ESR mean values.
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25.4 WATER DATA PRINTOUT - Graph meaning

The washing plot printing is to evaluate the efficiency of the ROLLER20LC photometer (CPS).
The graph visualizes the average, represented by a black circle, of the washings executed daily.
The instruments, normally, are regulated to give an absolute value, which is 3600, during the washing
process with distilled water. This value trends to decrease during the time because biological residuals
trends to deposit inside the capillary. A washing procedure for maintenance, as described in the “MANUAL
WASHING PROCEDURE” chapter, should reset the photometrical signal to 3500, roughly, value again. If
this value, instead decreases under 3300 or increases above 3700, the instrument will generate Z-0 error.
Press REPRINT key on MAIN MENU to activate the statistical data printout procedure.
STATISTICAL DATA Press key 4 to activate the graph printout which point out the trend of
M. (2) Sp. (3) W (4) the washing mean values.
NOT WASHED w
Where:
3300 3500 3700
├───┴───┴───┴───┴ w = Represents the missing washing number
xx. yyy ●
xx .yyy ●
xx. yyy ● xx.= Represents the washing progressive number
xx. yyy ●
xx. yyy ● yyy = Represents the water daily value read
xx. yyy ●
xx. yyy ●
xx. yyy ●
xx. yyy ●
xx. yyy ●
xx. yyy ●
vv.vv = Variation percentage coefficient.
CV% = vv.vv
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26 GAIN ADJUSTMENT
At the beginning of the instrument working life the analyzer comes to the user with the blood gain, called
BoosterY, set according with the Latex calibration executed in the factory where the analyzer has been
developed.
At the installation time or at the end of every maintenance service, the fitter or the technician in charge to do
maintenance should change the gain, if it is required or necessary, to balance the obtained ESR results with
those obtained previously by the referent method.
The fitter or technician, therefore, has to enable an option called Electronic Calibration and then it has to run
an analysis cycle after filling all 18 positions with test tubes.
At the end of the cycle and beyond the various options, the REPRINT key, which is pointed out on display,
activates even an additional option which will be displayed as io the following example:
6- CORR. %
ENTER EXIT
If key 6 is pressed, the display shows:
BoosterY Set
[1] Mod [2] Exit Press 1 to display:
ADJUST % ESR
Press CLEAR and type 1.xx (e.g. 1.10 to increase the ESR results to
10%) or 0.xx (e.g. 0.90 to decrease the ESR results to 10%) and press
+1
ENTER.
Note: in this context, PAUSE key is to make the point.
The next displayed information point out the obtained BoosterY gain.
BoosterY
Press ENTER
+X.XXXXX
Press key 2 to print out the modified RSR results and compare those with the results been obtained by the
referent method. If the results of both systems are balanced, then press ENTER to exit from the REPRINT field.
Otherwise if they need to be modified again, press key 6 and repeat the described procedure which can be
done for many times until it is achieved a good correlation.
After having obtained a good correlation, the fitter or technician has to disable Electronic Calibration
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27 MAINTENANCE TIME
A counter in the analyzer, counts the executed analysis from the last maintenance time.
When, along the working days, it reaches the preset maintenance warning again, which value is 30000
normally, the LED set on the left side, above the keypad, blinks
The operator, therefore, warned by the analyzer about the necessity to carry out a new maintenance service,
has to call the technician trained to carry out this stage.
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28 GENERIC ERROR LIST

Error Cause Effect Solution
code
Syringe error. The syringe doesn’t go On display appears the message Power off the instrument for 10
C-0 back to home position because sensors “Error C – ROLLER OFF” seconds and on again or call the
or motor malfunctions. Analytical cycle is aborted. technical service.
On display appears the message Power off the instrument for 10
D-0 EEPROM damaged / absent “Error D – ROLLER OFF” seconds and on again or call the
Analytical cycle is aborted. technical service.
On display appears the message Power off the instrument for 10
Commutation between EPROM’s banks
D-1 “Error D-1 – ROLLER OFF” seconds and on again or call the
not properly working
Rotor sensor error. The rotor doesn’t On display appears the message Power off the instrument for 10
rotate correctly because sensor or motor “Error E – ROLLER OFF” seconds and on again or call the
malfunction. Sometimes this error is also Analytical cycle is aborted. technical service.
E-0
due to the front door not closed well or
the sensor signal doesn't reflects to
metallic reflecting plate.
System clock error. The CPU clock On display appears the message Power off the instrument for 10
F-0 doesn’t run correctly. “Error F – ROLLER OFF” seconds and on again or call the
Washing not executed after the last On display appears the error Carry out a washing procedure.
analysis of the day. The wash missing “H” while the counter is
H-0 counter is incremented. incremented and the number of
NO washed reported in the flag
list.
Pump sensor not detected, the rotation On display appears the message Power off the instrument for 10
I-0 of the pump is not detectable for pump “Error I – ROLLER OFF”” seconds and on again or call the
motor or pump sensor malfunction. Analytical cycle is aborted. technical service.
Piston sensor not aligned with the On display appears the K error Call the service as soon as possible
K-0 external magnet or damaged. message.
Press ENTER key to continue.
The syringe lifter motor doesn’t rotates. On display appears the message Call the Technical Service as soon
M - 0 The piston is still at low position. “ Error M “ is possible.
Press Enter key to continue
Improper attempt to transfer credits of Call the Technical Service as soon
T-1 ESR from Transfer Smart Card to Press Enter key to continue is possible
ROLLER
Improper attempt to transfer credits of Call the Technical Service as soon
T-3 the other parameters from Transfer Press Enter key to continue is possible
Smart Card to ROLLER
Transfer attempt from ROLLER to Smart Press Enter key to continue Tech. Service message. The
U-0
Card with autonomy less than 1 transfer process cannot be done.
Gain value out of working range (min. Press Enter key to continue Call Technical Service
V-0
0.6000 - max 1,6000
Model Fact value out of working range Press Enter key to continue Call Technical Service
V-1
min. 0.50 - max 2.00
Booster Y value out of working range Press Enter key to continue Call Technical Service
V-2
min. 0.50 - max 2.00
Upgrading the instrument from release Press Enter key to continue This error will disappear
V-3
5.xx to release 6.xx automatically after pressed Enter
During the washing the water value is Press Enter key to continue Perform the washing procedure with
Z-0 outside the tolerance (800 - 1000) chlorine. If the error remains, call
the Technical Service.
Page 47
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
29 ALERTS LIST and LATEX ERROR LIST

Message Cause Solution
The blood flow was not regular, for air It is suggested to execute a washing cycle
NF is printed instead of ESR bubbles or tubing / needle obstruction. before proceeding with further analysis.
value
Result could be NR (not reliable) if the Try to mix again the blood and repeat the
NR (Not Reliable) is printed reading unit is able to detect the measure
instead of ESR value transition between air (empty capillary)
and blood, but is not able to detect the
starting of the aggregation. Sometimes
this is also due to a poor mixed blood.
This error appears when a sample has Check tubes loaded are in conformity with
CM = SM (Sample Missing) is been loaded in the instrument, but it has technical data sheet of the instrument
printed instead of ESR value slipped out from the rotor. Instrument is
expecting to find a tube (because it has
recognized it when loaded) but at the
time of perform the analysis the tube is
not physically inside the rotor
Increase Avail. The test availability is under 2000 test, Press Enter to continue.
Insert CARD the instrument alerts the customer that is To avoid the message, increase the
necessary increase the test availability availability inserting a new CARD.
The following message is The waste tank counter has reached the Replace or empty the waste tank, then press
printed at power up value of tank alarm (2000 by default) key “1- empty” to reset the counter to zero.
Waste level detected The instrument enters automatically in
EMPTY the tank waste tank replacing procedure (9)
The following message is The maintenance counter has reached Call the Technical Service for performing a
printed at power up the value of maintenance alarm (30000 30000 test maintenance.
Maintenance Request by default). Maintenance is required.
Checksum error XXX Error during the checksum control on 'R' Call the Technical Service for the host
message (Results) sent to Host connection.
computer
The three control tubes are expired, the Check the expiration data of the kit, if expired
Exceed expiry date calibration control could be unreliable, replace it with a new one and repeat the
Procedure aborted thus the procedure is aborted. control procedure.
Verify the date printed by the analyzer during
the power-up, correct it if not the current date.
The three control tubes have been used Repeat the control with a new kit or with a kit
Exceed control availability more than 6 times, the calibration control that was analyzed less than six times.
Procedure aborted could be unreliable, thus the procedure
is aborted.
The three control tubes don't report the If between the three test tubes, the codes are
Different kit number same lot number and the analyser is not different, probably one or more tubes comes
Check tube labels able to verify the calibration data from different kit or are from the same kit but
Procedure aborted coherence. from a different column (for the 30 test kit)..
The following message is The values read by the reading cell can Check that the three tubes have the same
printed not be extrapolated to a reference level of latex; check the needle is not
correlation line. The three values can not obstructed, if this happens, follow the washing
Correlation Not OK be plotted over a line and thus the procedures for maintenance.
correlation limit fall outside the minimum
reference R2 >= 0,97
The following message is The memory of expirations of the kits is Check the date of the analyzer, correcting it if
printed momentary not available or exhausted. is not the current one.
The date memorized from the analyzer Try to repeat the control after few days (two or
Unavailable memory in is not the current one. three) to verify if the memory frees an the
E2PROM message disappears.
Procedure aborted If after two or three days the message is still
printed, call the technical service.
Page 48
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
30 NEEDLE REPLACEMENT
To replace the needle be sure that the instrument is OFF. Follow the instruction and see the photo.
1) Open the front panel. 2) Pull firmly the piston assembly towards
you so that the retaining magnets release
the assembly.
3) Push down the piston for CBC adapter and with one 4) Replace the needle using the red special
finger of your other hand pull out the clip and remove tool tightening the new-one without force it
the piston completely. Be careful to the needle to avoid to damage the plastic thread part.
sharp tip that will come out from the piston top!
Use glowers to protect your hands!
Page 49
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
5) Insert the piston looking at its metallic 6) Push down the piston until the metallic
clip that has to fall down in front of you clip it will be over the aluminium hook.
Release the piston.
7) Push the piston assembly until the

magnets retain the piston assembly.
NOTE:
We suggest to do a washing procedure cycle after replacing the needle, using two samples filled to ¾ of
distillate water and verifying if the water flows from the tube through the capillary during the withdraw
without any problems.
Page 50
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
31 SOFTWARE REVISION HISTORY

Date SW Ver. Manual Rev.
21.11.05 Ver. 6.00A Rev. 01 Latex Control management.

New statistical data printing relate to the three levels of latex controls
06.02.06 Ver. 6.00B Rev. 02 Exchanged Booster Y and MFact functions to simplify calibration
Differentiate management of Latex Controls and Latex Calibrators
New statistical printout to evaluate the analyzer performances
Control of expiration date for both Latex Controls and Calibrators
26.05.06 Ver. 6.00C Rev. 03 Inserted new printings for the latex controls, every time the controls are
executed a printout shows also the reference values of the controls and,
if the analyzer gain (BoosterY) is different from 1.000, the new reference
values calculated with the new gain are printed to give a new comparing
table
Each variation of BoosterY parameter will modify both the latex controls
and the haematic sample results.
Inserted the management of the external quality control (called VEQ) that
disables the printing of the reference values when a kit is recognised as
an External Quality Control (VEQ).
Fixed software error that sometimes caused error E0 during the home
position searching rotation.
14.09.06 Ver. 6.01A Rev. 04 The functionality of the two amplification software parameters MFact and
BoosterY have again separate to allow the independent regulation of the
values of the latexes (MFact) and of those of the haematic samples
(BoosterY).
With the separation of the two amplification parameters, it has also
removed the printing of OUT OF STD with the relative new reference
values when the BoosterY parameter is different from 1.000.
New algorithm for calibration and control with latex, that allow a best
correlation and repeatability between instruments.
Fixed software error that didn't allow the correct management of offset
parameter during the rising of withdrawal piston.
23.04.07 Ver 6.01 A Rev. 05 Updated test tube characteristics, analytical and operative performances,
inserted method limitations and washing procedure if latex controls are
used daily.
20.11.07 Ver 6.01 B Rev. 06 Sw: inserted a routine to better control the stop of blood inside the
reading unit.
02.04.08 Ver 6.01 C Rev. 07 Released sw ver. 6.01C: Operator Manual: updated method limitations,
described sanitation procedures.
Sw: inserted a routine to better control the stop of blood inside the
reading unit.
Ver 6.01D These versions have never been released on the market.
Ver 6.01E
Ver 6.01F
27/08/09 Ver 6.01G Rev. 08 Correction of “Latex expiration date bug” causing Latex Controls and
Calibrators withdrawal even if not expired starting from lots produced in
September 2009 and then expiring in 2010 (from Lot no. 10xx and
further).
27/10/11 Ver. 6.51C Rev. 09 • Possibility to choose the typology of the result printing (detailed
or compressed).
• Multilanguage software (Italian, English, German, French and Spanish).
• Possibility to choose which kind of parameter can be printed out on
paper assuming they have been enabled by means of a Smart Card.
• Possibility to print out the limits next by the lowest and highest ESR
result. E.g. (ESR <2) , (ESR>120).
• Reduced the analysis from 24 seconds to 20.
Page 51
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
32 SANITATION PROCEDURE
The following procedure must be executed before:
1) Collection/shipment of the instrument from laboratory after a demo or for replacement/reparations.

2) Technical service repair or check inside the instrument.
Protection tools and suggested materials to be used:
1) Glasses.
2) Latex gloves.
3) Absorbing paper towels.
4) Plastic bag for waste disposal .
For the description of sanitation procedures of a working instrument: refer to the Sanitation Form (appendix E)
The Sanitation Form MUST be filled up and accompany the instrument.

.
In case the sanitation cannot be executed due to a failure of the washing system, contact your Local Technical
Service.
Note: we suggest to make a copy of the appendix B at each sanitation and to fill it according to the sanitation
procedure.
33 BEFORE SWITCHING OFF THE ANALYSER

Before switching OFF the analyzer it is strongly suggested to clean the capillary with three test tubes filled
with distilled water so that the needle remains inside the third test tube to maintain wet particles of blood still
present in it.
At the end of this process, the instrument prints out “WASHING EXECUTED” and “PHOTOMETER OK”.
Check the message and then turn the analyzer off pressing the rear side switch.
Page 52
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
34 REFERENCES
Manufacturer:
SIRE Analytical Systems s.r.l.

Via Merano 30 33045 Nimis (UD) Italy
Tel +39 0432 547454 - Fax +39 0432 547378
Company certified by
ISO 9001:2008 TÜV Italia S.r.l. 501006107

EN ISO 13485:2012/AC:2012 TÜV SÜD Product Service GmbH Q1N130371065001
ISO 13485:2003 (CMDCAS) TÜV SÜD America Inc. QS1130471065002
The instrument is CE certified

According to directive 98/79/EC relative to In Vitro Diagnostic Medical Devices
Worldwide distributor::
ALIFAX S.p.A.
via F. Petrarca 2
Isola dell'Abbà
35020 Polverara (PD)
Tel. +39-049-0992000
e-mail info@alifax.com
web www.alifax.com
Page 53
OPERATOR MANUAL
Ed. 1 Rev.13 -2014, April, 05
35 APPENDIX A - SANITATION FORM

This module must be filled by the Laboratory / Technical Service Engineer and attached to the instrument before the
shipment. The cleaning of the instruments can be difficult regards the elimination of the etiological agents of the TSE
(Encephalopathy Spongiform Transmissible). It is reported that after exposure to high titre preparations of TSE agents,
detectable infectivity can remain bound to the surface of the laboratory instruments. The removal of all adsorbed protein by
the use of sodium hydroxide or chlorine releasing disinfectants (e.g. 20 000 ppm. Chlorine for 1hour) have been considered
acceptable approaches where equipment that cannot be replaced as been exposed to potentially contaminated material.
Description of sanitation procedures to be done by the laboratory:
Switch ON the instrument:
OK NOK
 Execute the following washing procedure
1. Perform a first wash using two tubes filled with distilled water
2. Perform a second wash using one tube filled with water and one tube filled with
sodium hypochlorite.
3. Empty and clean very well the Waste tank avoiding to leave blood residual inside
For the disposal of the waste tank content follow the standard safety procedures
in use in the laboratory.
If due to a failure, the instrument cannot be switched ON, mark as NOK .
Description of sanitation procedures to be done by the Technical Service Engineer:
Wear protection tools (glove and glasses) and remove the cover of the instrument.
If Laboratory Operator marked the washing procedure as NOK, verify if it is possible to make in some way the
washing procedures.
 Execute the following washing procedure OK NOK
1. Perform a first wash using two tubes filled with distilled water
2. Perform a second wash using one tube filled with water and one tube filled with
sodium hypochlorite
3. Empty and clean very well the Waste tank avoiding to leave blood residual inside
For the disposal of the waste tank content follow the standard safety procedures
in use in the laboratory.
If due to a failure the instrument cannot be switched ON, mark as NOK
To continue with the sanitation procedure, switch OFF and unplug the mains cable.
 If some part inside the instrument are contaminated with blood:
1. Spray the parts with a disinfectant (cationic surfactants).
2. Collect liquid from the sprayed parts with absorbing paper towels.
3. Wash with water and dry with paper
For the disposal of the contaminated stuff and Waste Tank content, follow the standard
safety procedures in use in the laboratory.
 If there are no parts contaminated with blood:
Wash with water and dry with absorbing paper
For the disposal of the contaminated stuff and Waste Tank content, follow the standard safety procedures in use
in the laboratory.
In the event contaminated material is penetrated inside the instrument (thermostated plate) IT IS MANDATORY TO
INDICATE ON the INSTRUMENT and on the SANITATION SHEET that contaminated material has percolated inside
the instrument and it has not been possible eliminate using the external sanitation procedure.
MANDATORY:
If the sanitation was carried on, please cut the lover right side of the page (or make a photocopy) and include the tag in the
shipping documents.
SANITIZED
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Ed. 1 Rev.

Capillary Micro-photometer for the Erythro-Sedimentation Rate (ESR)

In Vitro Diagnostic Medical Device for Professional Use

Copyright  Alifax S.P.A.

USER MANUAL REVISIONS

Rev. Description Issue date

13 Inserted EAC certification Logo 05/04/2014

7 Re-written chapter 32 and add APPENDIX B Sanitation module. 02/04/2008

6 Chapter 13 updated 30/09/2009

5 Re-written the “Priming process” chapter 18/05/2009

4 “Washing procedure” chapter updated 20/01/2009

1 SIMBOLS INDEX AND LABELS

Symbol MEANING Symbol MEANING

Manufacturer Ground terminal connection

In Vitro Diagnostic Serial Number of the

SIRE Analytical Systems Made in ITALY Rx Only (USA)

PWR SUPPLY TEST OK

Roller20 s.n. ______

Technical Service Tel. No.

2 TECHNICAL SPECIFICATIONS (D102.06.03 - 1.9 )

Analytical performances (obtained with 3 ml Test-tubes):

ESR values N° Coefficient of

To do this evaluation, has been used 37 samples, obtaining a mean

2. Erythrocyte sedimentation remains an only partly understood phenomenon….is a

ENVIRONMENTAL AND PYSICAL SPECIFICATIONS

Humidity from 5% to 95% - no dew

INTERNAL QUALITY CONTROL

VARIOUS / OTHER FEATURES

Patient identification: External CCD bar-code reader (SI19582001).

- Simplified-needle replacing procedure with magnetic unlocking and screw needle

3 WARNINGS TO ENSURE A CORRECT INSTRUMENT USE

RISCHIO BIOLOGICO- USARE I GUANTI

PERICOLO - NON TOCCARE LA PARTE ALTA

 Instrument is compliant with IEC 61326 emissions and immunity requirements

PROCEDURE OF INSTRUMENT WASTE AT THE END OF ITS OPERATIONAL LIFE

4 UNPACKING AND INSTALLATION

5 VOLTAGE SELECTOR AND FUSES REPLACEMENT

To replace the fuses use the following procedure:

• Remove the fuse box

• Change both fuses (*)

• Insert the fuse box inside the

Photo 1 Photo 2 Photo 3

CBC syringe. Sarstedt syringe Terumo syringe

7 KEYBOARD SPECIAL FUNCTIONS

The keys are:

8 SWITCH the ANALYSER ON

UK ver. 6.51C Identification message of the installed software version

TEMP. 37.0 Nominal temperature of work.

9 WASTE TANK LEVEL MESSAGE

Pressing key 1, the printer is going to print-out a list as below:

0- AVAILABILITY 0. Is to increase the availability of test

Pressing key 2, the mixing function is going to be activated.

11 TO CHANGE DATE & TIME

DD/MM/YYYY where DD=Day, MM=month, YYYY=Year

HH:MM where HH=hour, MM=minutes

If time is correct press ENTER key.

12 PAPER LOADING PROCESS INTO THE PRINTER

5- Press PAPER FEED on keypad or on the printer to obtain

Photo 5 CUSTOM PLUS II

13 SMART CARD TO INCREASE CREDITS

…...if the card is already used. Remove the Used card

----------LOG SMART CARD----------

13.2 UNIVERSAL CARD