ROLLER 10 Technical Manual SW 2.00A - Ed. 1 Rev 2

Doc. No: D205.07.02 UK- Ed. 1 - Rev.
2
Software Version 2.00A - UK
Last revision: 18.05.2009
10 – 10PN – 20PN
TECHNICAL MANUAL
Software Version 2.00 A (Multilanguage)
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 10 family trademarks are property of Alifax S.p.A.
The ROLLER 10 family software is provided only with restricted and limited rights based on Italian regulations.
INDEX
ROLLER 10 – 10PN – 20PN PRESENTATION ............................................................................................................................................1

ROLLER 10 – 10PN INTERNAL VIEW...........................................................................................................................................................1
ROLLER 20 PN INTERNAL VIEW .................................................................................................................................................................2
ROLLER 10 – 10PN – 20PN REAR SIDE VIEW ..........................................................................................................................................3
INSTRUMENT PLASTIC COVER REMOVING ..............................................................................................................................................4
1.0 – ROLLER 10 TECHNICAL SPECIFICATIONS D205.06.03 - 1.7 – 27.05.2008 Technical Specifications UK ...................5
2.0 - WARNINGS ...........................................................................................................................................................................................9
3.0 - UNPACKING AND INSTALLATION .....................................................................................................................................................11
4.0 – PRELIMINARY CHECKS, FIRST INSTALLATION AND SOFTWARE UPGRADE ..............................................................................12
5.0 – WASTE TANK REPLACE / EMPTY ....................................................................................................................................................12
6.0 – WASHING TANK LEVEL CONTROL (Available only on PN Models) (under development) .................................................................12
7.0 – INCREASE AVAILABILITY TEST USING THE SMART CARD ( UP TO 6 PARAMETERS )...............................................................13
7.1 – SMART CARD ERRORS ........................................................................................................................................................16
7.2 – MULTIPARAMETRIC CARDS.................................................................................................................................................16
8.0 – SWITCH ON........................................................................................................................................................................................17
9.0 – MENU DESCRIPTION.........................................................................................................................................................................18
9.1 – MAIN MENU........................................................................................................................................................................................18
9.1.1 – MEASURE MENU ............................................................................................................................................................................18
9.1.1.1 – IDENTIFICATION BY External Bar Coded Reader ........................................................................................................................19
9.1.1.2 – MANUAL ID INSERTION OF THE PATIENT.................................................................................................................................20
9.1.1.3 – AUTOGENERATED ID..................................................................................................................................................................21
9.1.1.4 – MANUAL WITHDRAWAL PROCEDURE (ONLY FOR Roller 10PN and Roller 20PN)...................................................................22
9.1.1.5 – ANALYSIS RESULTS (Display and Printouts) ...............................................................................................................................24
9.1.2 – WASH MENU (Roller 10 Model) .......................................................................................................................................................25
9.1.2.1 – WASH MENU (Roller 10 PN and Roller 20 PN) .............................................................................................................................26
9.1.2.2 – INTERNAL WASH (Roller 10, Roller 10 PN and Roller 20 PN)....................................................................................................26
9.1.2.3 – AUTOMATIC WASH (Roller 20 PN) .............................................................................................................................................27
9.1.2.4 – EXTERNAL WASH (Roller 10 PN and Roller 20 PN)....................................................................................................................28
9.1.2.5 –WASHINGS PROCEDURE DESCRIPTION ...................................................................................................................................29
WASHING USING 2 TEST TUBES .................................................................................................................................................29
WASHING USING 3 TEST-TUBES (optionally third tube filled with a detergent liquid) ....................................................................30
WASHING PROCEDURE FOR MAINTENANCE (USEFUL ALSO IN CASE OF OBSTRUCTED TUBING AND/OR NEEDLE).......30
9.1.2.6 WASHING PROCEDURE IN CASE OF USE OF LATEX CONTROLS ..............................................................................31
9.1.2.7 – END OF WORKING DAY WASHING PROCEDURE (Wash and Sleep) .......................................................................................32
9.1.2.8 – WASHING ERRORS .....................................................................................................................................................................33
9.1.3 – STANDARD (Latex control / calibration) ...........................................................................................................................................34
9.1.3.a – BoosterY calculation .....................................................................................................................................................................37
9.1.4 – MIXER ..............................................................................................................................................................................................39
9.1.5 – EMPTY ROLLER..............................................................................................................................................................................39
9.1.6 – INTERNAL QUALITY CONTROL .....................................................................................................................................................40
9.1.6.1 – WASHING QUALITY CONTROL PRINTOUT - Graph meaning ....................................................................................................41
9.1.6.2 – “NORMAL” ESR AVERAGE CONTROL PRINTOUT - Graph meaning..........................................................................................42
9.1.6.3 – “GLOBAL” ESR AVERAGE CONTROL PRINTOUT - Graph meaning...........................................................................................44
9.1.6.3.b – INTERPRETATION OF THE STATISTICAL MEANING..............................................................................................................46
9.1.6.4 – “NORMAL” CUMULATIVE ESR DISTRIBUTION PRINTOUT - Graph meaning.............................................................................48
9.1.6.5 – “GLOBAL” CUMULATIVE ESR DISTRIBUTION PRINTOUT - Graph meaning .............................................................................49
9.1.6.6 – “NORMAL” DAILY ESR DISTRIBUTION PRINTOUT - Graph meaning .........................................................................................50
9.1.6.7 – “GLOBAL” DAILY ESR DISTRIBUTION PRINTOUT - Graph meaning ..........................................................................................51
9.1.6.8 –INSTRUMENT VERIFICATION USING THE LATEX CONTROL KIT .............................................................................................52
9.1.6.9 – ERASE STATISTICAL DATABASE...............................................................................................................................................54
9.2 – SETUP MENU.....................................................................................................................................................................................56
9.2.1 – CPS MENU ......................................................................................................................................................................................56
9.2.1.1 – CPS’ PARAMETERS.....................................................................................................................................................................56
9.2.1.1.a – MODIFY BOOSTERY’s VALUE.................................................................................................................................................57
9.2.1.1.b – MODIFY WHOLE PARAMETRES’ VALUES (Technical password required) .............................................................................58
9.2.1.1.c – MODIFY MODEL FACT’s VALUES ...........................................................................................................................................58
9.2.1.1.d – MODIFY Offset Sensors VALUES .............................................................................................................................................58
9.2.1.1.e – MODIFY THERMOSTAT reference value ..................................................................................................................................59
9.2.1.2 – CPS Read ADC .............................................................................................................................................................................59
9.2.1.3 – FIRST UP ......................................................................................................................................................................................60
9.2.2 – MIX MENU........................................................................................................................................................................................60
9.2.3 – DATE TIME MENU..........................................................................................................................................................................60
9.2.3.1 – MODIFY DATE TIME VALUE (User level password required) ......................................................................................................61
9.2.4 – FL (Flag List) MENU .........................................................................................................................................................................62
9.2.5 – SETTINGS MENU ............................................................................................................................................................................63
9.2.5.1 – SOFTWARE VERSION .................................................................................................................................................................63
9.2.5.2 – PRINT EXPANDED .......................................................................................................................................................................63
9.2.5.3 – PRINT IN RUN ..............................................................................................................................................................................64
9.2.5.4 – LANGUAGE SETUP......................................................................................................................................................................64
9.2.6 – SETTINGS MENU with “USER LEVEL” PASSWORD LEVEL ACCESS ..........................................................................................64
9.2.6.1 – WASH TIME ..................................................................................................................................................................................65
9.2.7 – SETTINGS MENU with “TECHNICAL LEVEL” PASSWORD LEVEL ACCESS ................................................................................65
9.2.7.1 – INSTRUMENT SERIAL NUMBER .................................................................................................................................................66
9.2.7.2 – DEBUG..........................................................................................................................................................................................67
9.2.7.3 – CONFIGURATION OF KIND OF ROLLER (Available from software version 1.00N)......................................................................67
9.2.7.4 – MAINTENANCE LEVEL RESET....................................................................................................................................................68
9.2.7.5 – MAINTENANCE LEVEL THRESHOLD SETUP .............................................................................................................................68
9.2.7.6 – INSTRUMENT GENERAL RESET ................................................................................................................................................69
9.2.8 – LOG IN-OUT.....................................................................................................................................................................................69
9.3 – AVAILABILITY MENU .........................................................................................................................................................................71
9.3.1 – WARNING LEVEL (User level password required) ...........................................................................................................................71
9.3.2 – DISPLAY AVAILABILITY..................................................................................................................................................................72
9.4 – COMM MENU (Technical password required) .....................................................................................................................................73
9.4.1 – SETUP MENU ..................................................................................................................................................................................74
9.4.1.1 – INSTRUMENT NUMBER...............................................................................................................................................................74
9.4.1.2 – TIMEOUT ......................................................................................................................................................................................75
9.4.1.3 – ATTEMPTS ...................................................................................................................................................................................75
9.4.1.4 – MISSING ID...................................................................................................................................................................................76
9.4.1.5 – DO ON TIMEOUT UART ...............................................................................................................................................................76
9.4.1.6 – ACK...............................................................................................................................................................................................76
9.4.1.7 – BAYER (only with BCI interface)....................................................................................................................................................77
9.4.1.8 – 6 Parameters Transmission (under development). ........................................................................................................................77
9.4.1.9 – PROTOCOL INTERFACE OPTIONS ............................................................................................................................................78
9.4.1.9.a – DAT 8 INTERFACE (NO QUERY) ..............................................................................................................................................79
9.4.1.9.b – DAT 15 INTERFACE (NO QUERY) ............................................................................................................................................80
9.4.1.9.c – BCI INTERFACE (QUERY).........................................................................................................................................................81
9.4.1.9.d – No HOST ....................................................................................................................................................................................81
9.4.1.10 – PROTOCOL INTERFACE EXPLICATION ...................................................................................................................................82
9.4.1.11 – LATEX PROTOCOL INTERFACE EXPLICATION .......................................................................................................................84
9.4.1 – TEST MENU.....................................................................................................................................................................................84
9.5 – TECH MENU (Technical password required).......................................................................................................................................86
9.5.1 – PUMP CONFIGURATION (NORMAL and PN MODELS) .................................................................................................................87
Automatic taking: ..........................................................................................................................................................................87
Manual taking: ..............................................................................................................................................................................87
Fast: .............................................................................................................................................................................................88
Retention: .....................................................................................................................................................................................88
Reset persistaltic: .........................................................................................................................................................................88
Wash pump: .................................................................................................................................................................................88
9.5.2 – SYRINGE AUTO ..............................................................................................................................................................................89
Up and Down: ...............................................................................................................................................................................89
Up in Wash: ..................................................................................................................................................................................89
9.5.3 – SYRINGE MAN (AVAILABLE ONLY ON PN MODELS) ...................................................................................................................90
Out limit: .......................................................................................................................................................................................90
9.5.4 – CARRIAGE ALIGNMENT (AVAILABLE ONLY ON ROLLER 20 PN INSTRUMENTS)......................................................................91
9.5.5 – ROTOR ............................................................................................................................................................................................92
9.5.6 – SENSORS........................................................................................................................................................................................93
9.5.6. a – ROTOR ADJUSTMENT FOR SARSTEDT TUBES.......................................................................................................................93
9.5.7 – ROTATING VALVE (AVAILABLE ONLY ON ROLLER 10 PN and ROLLER 20 PN INSTRUMENTS) ..............................................95
10.0 – FIRST INITIALIZATION AND STARTUP ...........................................................................................................................................96
11.0 – SOFTWARE UPGRADE .................................................................................................................................................................101
12.0 – NEEDLE REPLACE ........................................................................................................................................................................103
13.0 – INSIDE ROLLER Family Instruments ..............................................................................................................................................109
13.1 – UI Board and Syringe Group............................................................................................................................................................110
13.2 – Syringe Group Replacement and/or carriage realignment (Roller 10 and 10 PN).............................................................................111
13.3 –Syringe Group Replacement ONLY for Roller 20 PN ........................................................................................................................114
13.4 – Adjusting Needle excursion inside sample tube ...............................................................................................................................117
13.5 – Peripherals Hub Sensors and Boards ..............................................................................................................................................119
13.6 – Motor and Communication Boards...................................................................................................................................................120
13.7 – Peristaltic Pump ..............................................................................................................................................................................121
13.8 – Reading Unit....................................................................................................................................................................................122
13.8. a – Un-mounting the Reading Unit and Capillary Replacement (Roller 10) ........................................................................................123
13.8. b –Capillary Replacement and Un-mounting the Reading Unit (Roller 10 PN and 20 PN).................................................................129
To replace capillary from needle to rotating valve: .........................................................................................................................129
Replace capillary between external tip and Rotating Valve:............................................................................................................132
Reading Unit capillary Replace 1: ..................................................................................................................................................133
13.9 – Rotor Motor, Rotor Alignment and Rotor’s Sensors .......................................................................................................................137
13.10 – INSIDE ROLLER 10: Power Supply Board ....................................................................................................................................141
14 – OPERATIVE SOFTWARE UPGRADE AND BOOT LOADER REINSTALLATION .............................................................................142
14.1- OPERATIVE SOFTWARE UPGRADE (TAGS) .................................................................................................................................143
14.1.1 – Operational Software Upgrade......................................................................................................................................................144
14.2- UPGRADE OF the FIRMWARE (directly on the electronic boards) ...................................................................................................145
14.2.1 - PROCEDURE FOR THE REMOVAL OF THE COVER .................................................................................................................145
14.3- INSTALLATION ON THE PC OF THE SOFTWARE TO PROGRAM THE ELECTRONIC BOARDS.................................................146
14.4- INSTALLATION ON THE PC OF THE SOFTWARE TO PROGRAM THE DISPLAY ........................................................................146
14.5- PROCEDURE FOR LOADING “BOOT – LOADER” SOFTWARE ON ROLLER10 ELECTRONIC BOARDS ....................................147
14.5.1 - MOTOR BOARD SOFTWARE UPGRADE....................................................................................................................................149
14.5.2 – UNIT INTERFACE BOARD SOFTWARE UPGRADE...................................................................................................................149
14.5.3 - COMMUNICATION BOARD SOFTWARE UPGRADE ..................................................................................................................150
14.5.4 - ANALOG BOARD SOFTWARE UPGRADE ..................................................................................................................................151
14.5.5 - DISPLAY BOARD SOFTWARE UPGRADE..................................................................................................................................151
15.0 – ERROR LIST ...................................................................................................................................................................................153
15.1 – SYSTEM ERROR LIST .......................................................................................................................................................154
16.0 - SANITATION PROCEDURE ............................................................................................................................................................155
17.0 - SWITCHING OFF ............................................................................................................................................................................155
18.0 PROGRAMMED MAINTENANCE PROCEDURE..............................................................................................................................156
19.0 – SPARE PART LIST .........................................................................................................................................................................158
20.0 - ROLLER – REFERENCES..............................................................................................................................................................160
APPENDIX A - IMPROVEMENTS WITH SOFTWARE VERSIONS from 1.00A to 2.00A. .........................................................................161
APPENDIX B – SANITATION FORM .........................................................................................................................................................162
Note: The paragraphs written with the italic characters (as on this note), have been added or modified
respect to the previous version of the manual; the same is true in case the chapter appears in
blue in the index, this means the chapter has been added or there changes done inside this
chapter.
ROLLER 10 – 10PN – 20PN PRESENTATION
Samples Loading Smart Card Slot

Door
Touchscreen
Open Lever LCD
Printer
ROLLER 10 – 10PN INTERNAL VIEW
Rotor
Capillary
Piston Assembly
Waste Tank
D205.07.02 UK – rev 2 Software 2.00 A - Roller 10 – 10PN – 20PN Technical Manual Page 1
ROLLER 20 PN INTERNAL VIEW
Washing pump
Rotor with 20
positions
Capillary
Needle
Washing Cell
Input water tube

Discharge tube
from the
Carriage washing cell
Stepper Motor
Piston and
Carriage
Assembly
Waste Tank
Washing Tank
External Tip
for internal
motor
washing options
Retractable Tip for external

withdraw (useful for tubes with
plastic cap and/or paediatric tubes)
ROLLER 10 – 10PN – 20PN REAR SIDE VIEW
Main fuses box
Fan Intakes
MAIN Switch and Power

Supply Plug.
Voltage: 85 – 264
Switch Mode Power Supply
(SMPS)
EBCR Serial
Port
HOST
Computer Serial
Port
USB Port (future

applications)
To replace the fuses use the following procedure:

• Locate the fuses’ box
• Using 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 completely the fuse box
• Replace BOTH fuses (*)
• Then insert again the fuse box inside

the Main Switch block.
• Finally press firmly to assure the

box’s tongue fits on the hook
(*)
To work with 230 Vac fuse must be of 2.5 Amp
To work with 115 Vac fuse must be of 5.0 Amp
INSTRUMENT PLASTIC COVER REMOVING
To remove instrument’s plastic cover proceed as follows:
Remove the 4 screws using a Phillips screw driver and then unthread the cover form the instrument pulling a bit
both sides and then lifting up the whole plastic cover.
Remove the 2 screws located at the instrument’s upper rear side using a Phillips screw driver, then unthread the
metallic cover pulling toward you and then lifting up.
1.0 – ROLLER 10 TECHNICAL SPECIFICATIONS D205.06.03 - 1.7 – 27.05.2008 Technical Specifications UK
OPERATIONAL SPECIFICATIONS
NAME: The instrument is available in three different configurations:
SI R10 Roller 10: base model with one rotor for 10 samples
SI R10 PN Roller 10 Plus Needle: model with one rotor for 10 sample plus an external
withdrawal tip for pediatric test-tubes or for test tubes
without rubber cap
SI R20 PN Roller 20 Plus Needle: model with 2 rotors for 20 samples total equipped with
automatic washing system and manual external
withdrawal tip for pediatric test-tubes or for test tubes
without rubber cap
DESCRIPTION: Automatic Analyzer for Erythrocyte Sedimentation Rate (ESR) determination of human blood
ANALYSIS PRINCIPLE: Microphotometrical capillary using stopped flow kinetic analysis.
RESULTS: Given in mm/h on the range from 2 to 120 mm/h.
SAMPLE REQUIREMENTS:
Sample requirements common to all three models:

- the sample must be of whole blood collected in EDTA anti-coagulant.
- the blood sample must be neither coagulated nor hemolyzed.
- the sample must be tested within 4 hours from venipuncture or within 24 hours if kept at +4 / +8
°C, allowing it to warm-up to room temperature befo re testing.
- the minimum blood volume (dead volume) is 1 ml
- the working volume is 175 microliters (average) except for the first two samples from which
supplementary 116 microliters are withdrawn for priming. In total from the first two samples
around 232 microliters are withdrawn. In case there is only one sample, the amount withdrawn
for priming is around 232 microliters.
- samples separation into the capillary using air bubble.
- the blood samples must remain capped (don’t uncap and recap them since the instrument’s
performances would be affected).
Sample requirements specific for SI R10 PN / SI R20 PN in case of manual withdrawal:

- the minimum blood volume required for the analisys is 100 microliters, except for the first two
samples from which are withdrawn supplementary 66 microlites for priming. In case there is
only one sample, the amount withdrawn for priming is around 132 microliters.
- samples separation into the capillary using air bubble.
TUBE REQUIREMENTS: Test-tubes 13x75 mm like BD Vacutainer® or Greiner Bio-one or with 13 mm diameter and from
75 to 83 mm high, cap included (like for example the Sarstedt tubes that measure 11,5x66 mm
without cap).
The sample volume must 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
General Operative performances:
• New design with thermoplastic cover, front door for easy access to waste and washing tank and needle.
• Simplified and safe needle replacing procedure.
• Simplified Smart Card downloading.
• Photometer check after each washing, to ensure continuous control of instrument.
• New photometer (CPS) with three detectors for ESR analysis and blood flow management.
• New automatic washing programmable at the end of each cycle (Only Roller 20 PN Model).
• New withdrawal tip for pediatric test-tubes or for test tubes without rubber cap (PN Models).
• Management of Latex Controls for TEST1 family analyzers (Ord. code SI 305.100-A/SI 305.102-A or SI 305.300-A/ SI
305.302-A).
Operative performances for SI R10 and SI R10 PN instruments:
Automatic withdrawal:
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)..
First result available after 4,4 minutes (mixing) e 35 seconds (analysis), the other results are
printed every 35 seconds each; 10 samples processed in about 10 minutes (60 samples per
hour) without considering the time taken for loading and unloading of test-tubes from the
instrument.
The above throughput could be delayed in case of connection to the Host Computer with replay
output time more than 1 second.
Manual withdrawal (SI R10 PN model):

from 2 to 1000 rotations (recommended 32 RPM @ 140 rotations, about 4,4 minutes).
Results available after 4,4 minutes (mixing) e 35 seconds (analysis) per sample.
This times are considered without including sample loading and unloading from rotor and also
without considering the time for uncap and recap.
35 seconds is the time the instrument takes to perform the analysis,
The above operation could be delayed in case of connection to the Host Computer with replay
Operative performances for SI R20 PN instruments:
Automatic withdrawal:
from 2 to 1000 rotations (recommended 32 RPM @ 140 rotations, about 4,4 minutes)..
First result available after 4,4 minutes (mixing) e 35 seconds (analysis), the other results are
printed every 35 seconds each; 20 samples processed in about 16 minutes (75 samples per
hour) without considering the time taken for loading and unloading of test-tubes from the
instrument.
The above throughput could be delayed in case of connection to the Host Computer with replay
Manual withdrawal:
from 2 to 1000 rotations (recommended 32 RPM @ 140 rotations, about 4,4 minutes).
Results available after 4,4 minutes (mixing) e 35 seconds (analysis) per sample.
This times are considered without including sample loading and unloading from rotor and also
without considering the time for uncap and recap.
35 seconds is the time the instrument takes to perform the analysis,
The above operation could be delayed in case of connection to the Host Computer with replay
CAPACITY: Roller 10 / Roller 10 PN max 10 sample/session

Roller 20 PN max 20 sample/session
ANALYTICAL PERFORMANCES (obtained with 3 ml test-tubes):

2
Agreement: with TEST 1: R = 0.91
Repeatability: mean CV% = 15.3% on the whole range 2 - 120 mm/h
METHOD LIMITATIONS: 1. The erythrocyte sedimentation rate is a phenomenon confined to fresh blood and transient
(1), not a hematic 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, hematocrit, erythrocyte mean corpuscular volume, plasma viscosity, etc.) (1).
Based on the acquired experience, TEST 1 family instruments (TEST 1, MicroTEST 1, Roller 20
and Roller 10), are limitedly affected by these variables. 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)… (1) that is affected by several technical aspects (2). The
ESR is often normal in patients with cancer...(2).
International guidelines for diagnosis and management of multiple myeloma do not mention the
Erythrocyte Sedimentation Rate (3). It is then necessary to point out that even though TEST 1
analytical performances have been confirmed in patients affected by multiple myeloma (4,5),
there have been some cases of patients affected by multiple myeloma in which TEST 1 has
reported clinically negative ESR values in comparison to other methods. Based on this
experience there could be cases in which ROLLER 10 gives low ESR results likewise TEST 1 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
result 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. The use of such tubes optimizes the mixing
phase and consequently the results reproducibility.
ENVIRONMENTAL AND PHYSICAL 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.
Humidity : from 5% to 95% - no dew
Size and weight: Width: 240 mm

Depth: 380 mm
Height: 450 mm
Weight: 13 Kg.(Roller 10 )
14 Kg (Roller 10 PN)
16 Kg.(Roller 20 PN)
ELECTRICAL SPECIFICATIONS
Voltage: 85 - 264 Vac Power consumption: 66 W

Switch Mode Power Supply (SMPS) Switch on cons: 132 W
Frequency: 47 to 63 Hz
Classification: Class I (EN61010-1 – IEC 1010-1 – CEI 66-5)
OTHER OPERATIVE SPECIFICATIONS:
Heat dissipation in the environment: about 230 BTU/hour
Noise: at low speed mixing: 55,0 db(A)

at high speed mixing: 50,6 db(A)
Maximum rated altitude: 3000 mt asl
Communication: 2 serial RS232 ports located on the rear side of the instrument:
Port 1 (DB25) is dedicated to connect an external scanner
Port 2 (DB) is dedicated to connect the instrument to an Host Computer
1 USB serial ports (future applications)
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 and sensor’s life.
Restrictions: Indoor user appliance
Rated pollution degree: Grade 2
Working life of the instrument: 10 years (if maintenance is done correctly)
INTERNAL QUALITY CONTROL
Latex Controls: Latex Controls for TEST 1 family analyzers allow the control of the calibration stability of TEST 1,
MicroTEST 1; 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
TEST 1 Family Quality Control: it is a software (code SI19562001) designed to collect and process the data from one or
more TEST-1 family analyzers (TEST 1, MicroTEST 1, Roller 10, Roller 20) for evaluating their
performances.
CONSUMABLES
Printer Paper: Thermal roller paper 58 +0/-1 mm x Max 32 mm external diameter
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 RC901) - 4,000 (Ord. code SI RC904) - 10,000 (Ord. code SI
RC910) - 20,000 (Ord. code SI RC920) test / Smart Card
Waste Tank: 500 ml plastic waste tank with screw cap.

Wash Tank: 500 ml plastic waste tank with screw cap (Available only on SI R20 PN Model)
OPTIONAL AVAILABLE TOOLS
Patient identification: External CCD bar-code reader (SI19582001)
REFERENCES:
1. NCCLS “Reference and Selected procedure for the Erythrocyte Sedimentation rate (ESR) Test; Approved
Standard-Fourth Edition”, Vol. 20 No. 27
2. Sox HC, Liang MH: “The Erythrocyte Sedimentation Rate”, Annals of Internal Medicine 1986; 105:515-523.
3. NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology “Multiple
Myeloma” (V.I.2007)
4. Ajubi et al.: “Determination of the lenght of sedimentation reaction in blood using the TEST 1 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
5. Mercurio S. et al.: “Comparison between two methods for ESR measure in patients affected by myeloma”,
37° SIBioC National Congress, 11-14 October 2005 Rom e.
2.0 - WARNINGS
The manufacturer does not assume any responsibility for eventual 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.
The syringe group, like the carriage group (Roller 20 PN) moves on “self-lubricating „ sliding guides it is
not therefore necessary to lubricate or to add to any kind of oil or grease to the guides.
Check the instrument is connected to an efficiently ground before its use.
Check the waste tank level before starting the measures, empty or replace the waste tank, if filled to
security level, following the standard safety procedures in use in the laboratory .
Switch to ON the instrument and wait 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 not neither haemolysed nor
coagulated. The optimal performance of the instrument is obtained using exclusively blood samples
withdrawn in EDTA anticoagulant (K2 or K3)
The blood samples must remain capped (don’t uncap and recap them since the instrument’s
performances would be affected Except if analyzed using the external widtrowing tip).
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 such tubes
optimizes the mixing phase and consequently the results reproducibility.
Start analysis within 2-4 hours from venipuncture, 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
Follow the "WASHING PROCEDURE" for a good maintenance of the instrument.
For professional in vitro medical diagnostic use only.
The instrument is designed for indoor uses only
If the instrument has been stored in cold places, wait at least 30 minutes before switching ON the
instrument for the first time in order to avoid eventual damages due to dew presence on internal parts of
the instrument.
Keep away any kind of objects, liquids, or substances not required for the instrument’s use from the
instrument.
Switch OFF the instrument before connecting any external peripheral as external bar code readers, printer
cables and/or RS232 serial cables.
Use only original spare parts supplied by the manufacturer.
Do not remove the panels neither camper the reading sensor. The maintenance operations must be
carried out only by technical personnel authorized by the manufacturer.
For your safety, if any parts are damaged, ask for the immediate replacing with original spare parts,
specially for the parts connected to mains (power cord, fuse-holder and mains switch …)
Avoid the use of the instrument near electromagnetic sources like for example cellular phones, CB’s, radio
transmitting units and similar.
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.
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.
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
PROCEDURE OF INSTRUMENT DISPOSAL AT THE END OF ITS OPERATIONAL LIFE
As stated on European directive 2002/ 96/CE relative 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 (WEEE).
The separate collection of this instrument at the end of its life is organized and managed by You as Importer. The user then,
will contact You and follow the system you have adopted in compliance with your national requirements.
The unauthorized disposal will be pursued according to the local laws and the rules in the nation of use. The penalties will be
effective, proportionate and dissuasive.
3.0 - UNPACKING AND INSTALLATION
Personnel qualified for the installation

The installation of this apparatus cannot be done from the final user, but it must be done only from a qualified
technician authorized from the manufacturer, to avoid the invalidation of the guarantee. In this way, each possible
problematic that it could jeopardize the operation of the instrument of its results, can be evaluated and eventually
resolved from fully trained personnel for these eventualities.
Packing control
The instrument comes packed in a carton box. Before proceeding with the unpacking, perform a control of the
packing, verifying the sides and the corners of the box for possible damages. Any damage must be reported on
the Installation and Testing Form, enclosed to the documentation of the instrument.
Unpacking
Open the pack from the top, extracting the first box that contains the accessories and then extract the instrument.
Place the instrument on the table for allowing the removal of the protective nylon foil. 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 the correct installation
and the correct operation of the instrument; all these accessories are exactly listed on the Packing List form and
they could vary according to the instrument configuration.
The content of the packing and the accessories box must be at least the following:
no. 01 ROLLER 10 instrument
no. 01 operative manual (this one that you are reading now)
no. 01 Packing List form
no. 01 Installation and Testing form
no. 01 Declaration of CE compatibility
no. 01 Final Testing certificate
no. 01 mains cable
no. 02 rolls of thermal paper (one is installed, one into the accessories box)
no. 02 waste tank (one is installed, one into the accessories box)
no. 02 mains fuses
Moreover, in accordance with the configuration, the following accessories can be present:
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 13 Kg) and providing enough
space on the right side to reach the power supply switch, located on the high back side of the instrument.
Choose a location sheltered from the sun direct light and far from sources of moisture, to allow a reliable operation
and a better duration of instrument operational 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 eventually the data cable for the connection with the Lab Informative System (LIS).
Avoid if possible the connection to mains through plug adapters and choose an electrical outlet far from any strong
impulsive voltages, usually generated from centrifuges, refrigerators, elevators and freight elevators.
As reported on the technical specifications, the instrument can handle a voltage from 85 to 256 Vac thus it is not
necessary a voltage selector.
Before power on the instrument, control also the presence and the connection of the waste tank, opening the front
door of the instrument.
After above controls, proceed with the lighting of the instrument, verifying that all the initialization procedure is
correctly completed as described on the Technical Manual of the instrument.
Any possible anomaly must be signaled on the Installation and Testing form.
4.0 – PRELIMINARY CHECKS, FIRST INSTALLATION AND SOFTWARE UPGRADE
Before switching on the instrument is MANDATORY to
• check out the waste tank level and empty or replace it if filled to security level, following the standard
safety procedures in use in the laboratory.
• if it is installed check the wash tank level and fill up with distillate water.
After switching on the instrument is MANDATORY to
• Check the availability of thermal paper
• In case of use of Sarstedt tubes, please refer to chapter 9.5.6.a
• Wait 20 minutes to allow the reading unit reach the thermal stability
For the first installation, please refer to chapter 10
For software upgrade, please refer to chapter 11
5.0 – WASTE TANK REPLACE / EMPTY
Roller 10 control has an internal counter which is incremented at the end of every analysis cycle. This function
calculates the volume of blood unloaded in the tank. When the prefixed threshold alarm is reached, the display will
show a warning message telling the threshold level for the waste tank has been reached and asks to empty or
replace the tank.
At this point, before starting a new analysis cycle, is mandatory to empty or replace the waste tank.
WARNING!! the instrument will set itself in idle and will not allow any kind of activities up to the “EMPTY” button
is not pressed, after that the waste tank counter is reset to 0 and the instrument is ready to star analyze samples
From software version 1.00N the control system has been changed, is not more necessary to set up one
threshold alarm because:
• at every switch ON of the instrument
• at every washing procedure start-up
• at the beginning of every cycle of analysis the instrument controls the level
of liquid inside the waste tank, using the peristaltic pump to aspire from the
tank. If the pump aspires material, the reading unit detects the presence of
the material and blocks the operation of the instrument, informing via
display that the waste tank needs to be emptied/replaced.
• It is important to NOT REMOVE/CUT waste tank discharge tube because
the length is designed specifically for measure safely the level of the waste
tank and advise the operator to empty the tank. 45 mm
• The safe length MUST BE AT LEAST 45 mm
For the disposal of the waste tank content follow the standard
safety procedures in use in the laboratory.
6.0 – WASHING TANK LEVEL CONTROL (Available only on PN Models) (under development)
This function is under development; it is suggested to check water level inside the washing tank and, for security,
fill-up at the beginning of the working session.
7.0 – INCREASE AVAILABILITY TEST USING THE SMART CARD ( UP TO 6 PARAMETERS )
Roller 10 has been developed to analyze up to six blood parameters. This means that according to the blood
desired parameters to be analyzed, will be available different test cards and each single card will upgrade only
the tests for which has been programmed.
Independently from the kind of test, the warning threshold is the same for all them, in other words, setting the
warning level to a specific value, means that that value will be the reference for all type of tests that has been
charged.
When the prefixed threshold alarm is reached by one of the test parameters, the display will show a warning
message telling which are the quantities of test available of each parameter.
In any case if, at least one parameter has a positive amount available, Roller 10 will allow to make an analysis
cycle even if at the end the availability will be negative.
The report will show ONLY the results for the available parameter.
For example:
Imagine the following situation: Warning threshold set to 3 and the following availability
Availability before
Parameter
analysis cycle
ESR 10
A new analysis cycle is started, the instrument will show the above information. The analysis is performed on 4
samples, so at the end this will be the availability
Availability after
Parameter
analysis cycle
ESR 6
The printed out results nor the information sent to LIS will be:
Parameter Results
ESR For 4 samples
Be careful that next time an analysis will be request, the instrument will perform it ONLY to the positive available
credits.
As an example:
A new analysis cycle is started, the instrument will show the above information. The analysis is performed on 10
samples, so at the end this will be the availability
Availability after
Parameter
analysis cycle
ESR 6
The printed out results nor the information sent to LIS will be:
Parameter Results
ESR For first 6 samples
WARNING!! If at the end of cycle no one parameter has a positive residual availability, the instrument will set
itself in idle and will not allow any kind of activities up when the availability will be increased using the specific
smart card.
To increase availability, it is necessary to be in MAIN SCREEN (if the card is inserted while the display shows a
different menu, it will not considered) then insert the appropriate smart card in the reading slot, facing the card
with the integrated circuit toward the left side, like displayed on the picture on chapter 7.1
The instrument will printout and display the current availability,
then will check the personalization:
• If the instrument’s personalization is different from the one programmed in the card it will reject the card.
• If the instrument have no personalization, it will show a message advising that it has no personalization and
will ask to acquire the one set in the smart card.
• if the personalization is the same as the one stored in the card (or the personalization has just been set up
like in the previous step) the instrument will show on display the actual personalization as shown:
Pressing Back the instrument will show the availability of the card inserted inside the slot. In the following image,
the card has an availability of 1000 test and has been programmed to upgrade all the 6 parameters. Other
kind of card will upgrade one or more, but not all the parameters.
Pressing Back again the instrument will show the new availability (as indicated in the next image) and will ask to
remove the card. After that it will display again the MAIN MENU
If, for some reason, the card inserted is defective the instrument will show a message informing about that and
asks to insert a new card, or by pressing “Abort” stops the transfer, in this case it will ask to remove the card,
after that will go back to MAIN MENU.
If the defective card is removed (without pressing Abort), the instrument will show again the actual availability and
allow to press “Continue” to go back to MAIN MENU otherwise if a valid card is inserted, it will start the
procedure as previously described.
In case of not properly card loading: possibly malfunction causes are explained in chapter 7.1
7.1 – SMART CARD ERRORS
The possibly malfunction causes usually are:
1. The smart card is not properly inserted (upside-down) or the Card contact plaque wouldn’t be in the lower
position faced to the instrument.
2. The reader contacts don’t allow the Card to be read.
3. Out Std error means the card has a number of tests that is outside the normal ranges: 1000 – 4000 –
10000 – 20000
4. Not valid Card means the card has already been previously loaded, so the instrument is not able to load
again, or the card is not personalized for this instrument. Take care that Test1 card works only with Test 1
instrument, while Roller/MicroTest1 cards can be loaded only on Roller and Microtest1 instruments.
If the instrument displays error OUT STD 24384 means the card has been inserted upside down or with
the contacts facing the left side instead the right side
GOOD WRONG
ATTENTION:
IN THE VERY FIRST GENERATION OF INSTRUMENTS (BASICALLY ROLLER 10 up to Sn 30) SMART CARD
MUST BE INSERTED AS DISPLAYED IN THE RIGHT PHOTO
Please refer to Chapter 9.3 to see the complete and detailed explication and procedures to set the warning level
and to see the availability.
7.2 – MULTIPARAMETRIC CARDS
With the use of multiparametric cards is possible to activate the analysis of one or more parameters.
At the moment is available the classical ESR card and the ESR + AnF Factor
8.0 – SWITCH ON
Start the instrument by pressing the switch on upper backside, the instrument automatically will start the internal
check up and then display will show the following image:
then, depending the kind of Roller configured, will be changed, in this case (Roller 10) the main screen will be:
This instrument is controlled using the “Touch Screen”, each option, function, process will be activated/deactivated
simply touching the screen in the corresponding “button”.
Available buttons are displayed in the upper screen side:
• Main: allows accessing to common use functions like measure, wash, mixing, and Quality Control
• Setup: allows accessing to some common use functions like date&time, mixing parameters and
also to specific functions protected by passwords (accessible only to technical service)
• Availability: allows accessing to set the test credit warning alarm and also to printout the availability of
credits
• Comm: allows accessing to communication functions protected by passwords (accessible only to

technical service)
• Tech: allows accessing to the whole Technical Menu, protected by passwords (accessible only to
technical service)
• Credits: allows accessing to some references, useful information and technical phone numbers
To be even more user friendly, as you can see, the main screen sets up ready to uses highlighting the 4 main
buttons in order to allow the operator begin analysis without necessity to “look around” for the operative buttons.
9.0 – MENU DESCRIPTION
In the next pages will be explained the functionality of each menu.
WARNING!! Remember that not all the functions inside each one of the menus are freely accessible; the
instrument has four levels of access:
Level 1 Operator Access: free without password can access only some functions like date&time
Level 2 Coordinator: require password can access Level 1 and the Setup functions
Level 3 Technical Service: require a password, allow access to all functions; this password is ONLY
for Technical Service and Alifax Manufacturing dept.
9.1 – MAIN MENU
Main Menu:
Pressing “Main” in the MAIN SCREEN, the instrument shows the following options
9.1.1 – MEASURE MENU
Measure:
Pressing the option “Measure”, the instrument, depending on the model (base model or PN model), requires to
select if the withdrawal will be executed using the external aspiration (paediatric samples or tests-tube with non
perforable plastic cap) or through the internal needle. To such purpose the instrument (only PN models)
requires the operator to select the type of wished withdrawal method, like shown in the photo:
Then, independently from the option previously chosen, the instrument set itself to startup a new session: it
checks the state of the rotor, controls the level of the waste tank, controls the availability of credits and requires
to load the samples one by one to analyze like shown in the photo:
9.1.1.1 – IDENTIFICATION BY External Bar Coded Reader
If the sample is identified by a BCR, read using the external scanner the instrument will show the red ID number
on the screen and after that will move ahead 1 position the rotor in order to allow the sample insertion.
WARNING!! The tube MUST be inserted ONLY AFTER the instrument shows on the display the read ID as in the
following example:
If by mistake has been read the wrong patient ID, just pressing “Delete” is possible to erase the ID and read
again the correct one.
To insert the tube open the tilting door, insert the tube in the available tube holder; the instrument has two
sensors to detect the presence of the tube’s cap and also to detect the presence of fingers. If after few seconds
the outer sensor still detect the fingers, the instrument will show on the display the following message:
Otherwise this one:

as is possible to observe, after the loading of the first sample, the instrument shows the “Start” button; pressing
it the instrument start the analysis.
If more samples are required to be analyzed just repeat the procedure or reading ID using the EBCR.
This means that the instrument is ready to read the next sample’s ID by EBCR or, by pressing:
OK: The instrument will start the analysis cycle

Delete Will ask to remove all the previous inserted tubes, checking one by one they has been removed
9.1.1.2 – MANUAL ID INSERTION OF THE PATIENT
If the instrument doesn’t have an external bar code reader (EBCR) but in any case the sample is identified by a
barcode label, it is possible to load sample’s ID by “keyboard” as explained in this chapter.
After have pressed “Measure” in the Main Menu, the instrument shows the following message:
now pressing “Manual ID” the instrument allow to type manually the sample’s ID then, pressing “ENTER” (in this
case the left arrow) the instrument will ask to insert the tube, then pressing “OK” the instrument shows this
message and moves the rotor to the corresponding position to allow the operator insert the tube.
Otherwise this one:

If more samples are required to be analyzed just repeat the procedure.

9.1.1.3 – AUTOGENERATED ID
If the instrument doesn’t have an external bar code reader (EBCR) and/or the sample tube doesn’t have a Bar
Code Label, it is possible to insert the tube allowing the instrument to autogenerate progressive ID .
After have pressed “Measure” in the Main Menu, the instrument shows the following message:
now pressing “Auto” the instrument allow to type manually the sample’s ID then, pressing, then pressing “OK” the
instrument shows this message and moves the rotor to the corresponding position to allow the operator insert the
tube.
Otherwise this one:

If more samples are required to be analyzed just repeat the procedure.

The autogenerated code is composed by a numeric sequence made by the following series of numbers: which
represents the cycle number, the serial number of Roller 10, the wheel number and the position of tube in the rack
(1÷10).
Print-out example:
[Instrument s/n] [Wheel number]
0307920106
[Cycle number] [Sample position]
9.1.1.4 – MANUAL WITHDRAWAL PROCEDURE (ONLY FOR Roller 10PN and Roller 20PN)
When using the external withdrawal procedure, it is mandatory to use gloves and all the others protective tools,
precautions and warnings necessary apt to avoid the contact in accordance with national laws.
Independently from the identification method, when using the external withdrawal, the instrument will ask to load
the samples and will mix them; then (after the mixing cycles have been executed) the instrument will require to
remove the samples from the rotor.
If the analysis is done after a washing procedure, the instrument

will execute a “Priming procedure”. The priming procedure will
mix the blood loaded for the half of the total mixing cycles (in any
case the minimum number of cycles done for mixing is not lower
than 10), then the instrument asks to remove tube 1and withdraw a
small quantity of blood for the priming, then it rotates the rotor by 1
complete turn to return in position 1 and asks to reload the tube;
after that, it continues with the mixing cycles till reaches the
programmed mixing cycles. (Note: in case of pediatric samples
that normally contain few blood, in order not to waste them,
the withdrawal for the priming can be done using a previous
analyzed sample or blood belonging to an adult).
After the mixing, rotor moves in a position where only one specific
sample can be picked by, to avoid to pick up the wrong one.
After having withdrawn the sample to be analyzed, the

instrument will move down the external tip allowing the
operator to insert the tube containing the sample to be
analyzed.
Pressing “OK” and then “Sample” to start the aspiration of the blood.
Note: Before pressing “Sample”, be sure that the
tube is inserted in the external tip.
After that, the instrument will begin to
withdraw the quantity of blood required for
the analysis; when the aspiration is finished,
instrument will beep 3 times, this means the
tube must be removed from the external tip
and recapped.
The tube can be reloaded on the rotor or left outside the instrument (external rack) for other eventual analysis.
After the analysis has been performed, the instrument

will show on the screen the results of the sample. Now
pressing “Back” the instrument will ask to clean the
external tip
To clean the external tip, use simple paper without

adding any kind of detergent. Clean gently the tip
moving from the top to the bottom, do not pull too hardly
in order to avoid to damage the tip. After having cleaned
the tip, press “OK”.
The instrument will move the rotor to the next position and will ask to pick the next sample to be analyzed.
During the analysis the instrument will display on the screen the results obtained. Based on the printer setup, the
printer will printout the results in “real time” (that means after each single analysis) or globally at the end of the
analysis cycle.
The result printout looks like the one showed here:
For each sample is reported:

Date and time of analysis
ID number
ESR results expressed in (mm/h)
Attention, if the waste tank is full (the control is executed

automatically by the instrument before beginning a new
session), it is necessary to empty the waste tank before
starting a new session; otherwise, the instrument
remains in standby until when the waste tank is emptied.
9.1.1.5 – ANALYSIS RESULTS (Display and Printouts)
After the sample analysis (independently of the internal or external withdrawal) the instrument will show on
display results and also printout each sample analysis’s result.
During the analysis the instrument will display on the screen the result obtained. Based on the printer setup, the
printer will printout the results in “real time” (that means after each single analysis) or globally at the end of the
analysis cycle.
The printout result looks like the one showed here:
For each sample is reported:

Date and time of analysis
ID number
ESR results expressed in (mm/h)
, in this case all 6 parameter’s result are displayed, if (as explained in
chapter 7 Increase Availability Test Using Smart Card) one or more
specific parameters are not available, the instrument will printout only
the results for the available parameters.
Attention, if the waste tank is full (the control is executed
automatically by the instrument before beginning a new
session), is necessary to empty the waste tank before
starting a new session; otherwise, the instrument remains in standby until when the waste
tank is emptied.
9.1.2 – WASH MENU (Roller 10 Model)
Wash:
Pressing “Wash” (from Main Menu or from Main Screen) the instrument will set itself to be ready to perform a
wash cycle, will check the rotor status (requiring to remove eventually present tubes)
and then will ask to load, two tubes filled ¾ with distillated water.
At the end of the washing cycle the instrument will printout the photometer parameter and also will show the
same parameter on the screen.
If for any reason the washing procedure reports “PHOTOMETR NOT OK” means that the washing cycle has
not been executed correctly.
Possibly malfunction causes usually are
Now pressing “CLEAR”; the instrument will display the following message that suggest to repeat the washing
procedure.
Attention, if the waste tank is full (the control is executed automatically by the instrument
before beginning a new session), is necessary to empty the waste tank before starting a new
session; otherwise, the instrument remains in standby until when the waste tank is emptied.
9.1.2.1 – WASH MENU (Roller 10 PN and Roller 20 PN)
Wash:
Pressing “Wash” (from Main Menu or from Main Screen) the instrument will set itself to be ready to perform a
wash cycle, will check the rotor status (requiring to remove eventually present tubes)
At this point, instrument requires to select the kind of wash desired:
This option is available

ONLY in Roller 20PN
configuration (chapter
9.1.2.3)
Now the operator need to choose the kind of wash and the instrument will activate the corresponding
procedures:
9.1.2.2 – INTERNAL WASH (Roller 10, Roller 10 PN and Roller 20 PN)
In this configuration, the instrument requires to load 2 tests-tube filled 3/4 with distilled water and then active the
washing procedure.
At the end of the washing cycle, the instrument will printout a report in which it shows the parameters of the
photometer and it will also show them on display, like in the following example.
If for any reason the washing procedure reports “PHOTOMETER NOT OK” means that the washing cycle has
procedure.
9.1.2.3 – AUTOMATIC WASH (Roller 20 PN)
In this configuration, the instrument executes the washing using the water available in the washing tank located
inside the instrument; it is not required to load washing test-tubes.
procedure.
9.1.2.4 – EXTERNAL WASH (Roller 10 PN and Roller 20 PN)
Using this option (PN Models), the instrument executes the wash of the hydraulic circuit connected to the manual
withdrawal needle.
IN this case the instrument doesn’t require to load washing tubes because the washing is executed manually; the
instrument moves down the external tip to the withdrawing position, from where it will aspire water from the
washing tube.
It is only displayed the following message:
Pressing “OK” the instrument begins the external washing procedure aspiring water from the tube that, of
course, must be uncapped. At the end of the washing cycle, the instrument will printout a report in which it
shows the parameters of the photometer and it will also show them on display, like in the following example.
procedure.
9.1.2.5 –WASHINGS PROCEDURE DESCRIPTION
This procedure is designed to guarantee the capillary and all the hydraulic circuitries are maintained clean and
free of blood residuals.
Considering the instrument uses a Teflon tube in which blood, water and latex flows, it is normal that the internal
walls of the capillary tend to become opaque, and also to remain dirty because some blood residual parts remain
inside the capillary.
To ensure a long lasting capillary, the instrument allows to use four different washing options (according to the use
of the instrument: with or without use of latex).
In any case it is important to remember that the use of latex overcomes all the problems related to the use of
haematic samples as control standards.
Washing options:
• Washing using 2 test tubes
• Washing using 3 test tubes (optionally third tube filled with a detergent liquid like those used in CBC)
• Maintenance washing
• Washing if latex controls are used.
At the end of every washing procedure the software, with the attempt to reach the original value (called white
value) which is 3800, updates an internal compensator factor value according to the read water value (e.g. Wt.
3796).
To every incorrect washing procedure, (water value >4095, <2000 water mixed with bubbles, anomalous water
flow, etc.) the instrument will generate a PHOTOMETER NOT OK error and a new washing procedure will be
requested.
WASHING USING 2 TEST TUBES

This option is used when the instrument requires or needs to be washed in a "normal" way. After this has
ended the instrument is ready to continue working.
This procedure requires to load 2 test tubes filled 3/4 with distilled water; tubes are loaded in position 1 and 2 of
the rotor.
To activate the procedure select Wash from the MAIN MENU, and the choose “Internal” and load the tubes and
wait until the "MAIN MENU (0)" is displayed enabling further choices.
For PN Models, if necessary to wash the external windrowing circuit (manual windrowing), choose the “External”
option, in this case, will be washed out the external windrowing circuit.

ONLY in Roller 20PN
9.1.2.3)
At the end of the washing

procedure, the instrument
will be ready to continue with
the analytical sessions.
WASHING USING 3 TEST-TUBES (optionally third tube filled with a detergent liquid)
This option is used at the end of the working day and offers the possibility to maintain the capillary moist
overnight. This is useful because all the hydraulic circuitry remains filled with water or with detergent (CBC
detergent).
The advantage of this procedure is that all residual blood particles that eventually have remained inside the
capillary, are kept moist avoiding them to remain stuck over the internal capillary walls.
This procedure requires 3 test tubes that will be loaded in two consecutive steps.
First step is the same described in the previous chapter “washing using 2 test-tubes”.
In the second step, independently from the typology of chosen wash (Internal, Automatic or External), the
instrument prints out the result of washing procedure, then requires to remove the two tests-tube, only if the
instrument is Roller 10 or Roller 10PN, while for the Roller 20 PN requires it ONLY if the “Internal” washing has
been chosen. After have removed the tests-tube from positions 1 and 2, the instrument, independently from its
configuration, requires the insertion of an ulterior test-tube always with distilled water (or cbc liquid detergent) in
position 1. From this test-tube it will windrow approximately 1/3 of the content, then the instrument will stop the
pump leaving the needle inside the test-tube and it will ask to switch OFF the instrument.
This system maintains all the hydraulic circuit filled with water (or cbc detergent) and avoids that eventual residual
particles of blood dries and stick to the inner wall of the capillary.
At the next switch ON the instrument will empty the residual water from the capillary and will ask the removal for
the test-tube
If the third test-tube had been filled up with liquid detergent, an ulterior washing must be executed using 2
tests-tube filled up for ¾ with 'distilled water; this washing is used to remove completely all the residual liquid
detergent before beginning a new analytical session.
The procedure of washing with 3 tests-tube IT MUST BE DONE at the end of the working day in order to
guarantee a good and efficient maintenance of the instrument
WASHING PROCEDURE FOR MAINTENANCE (USEFUL ALSO IN CASE OF OBSTRUCTED TUBING AND/OR NEEDLE)
This option MUST be used if the instrument works without latex controls.
For a good maintenance of the instrument it is required to use Sodium Hypochlorite (diluted at 5%) on a specific
basis according to the quantity of samples analyzed daily:
20 or less samples a day: every 2 weeks

40 or less samples a day: every week
60 or more samples a day: twice a week
Execute one first washing, selecting “Wash”, then option “Internal”, load 2 test-tube filled ¾ with
distilled water in positions 1 and 2 of the rotor.
ONLY in Roller 20PN
9.1.2.3)
Execute a second washing selecting “Wash” then option “Internal ” and to load in position a 1 test-tube
filled up ¾ with sodium hypochlorite (diluted at 5%), while in position 2, a test-tube filled up ¾ with
distilled water.
Execute one third session of washing selecting “Wash”, then option “Internal”, load 2 test-tube filled ¾
with distilled water in positions 1 and 2 of the rotor.
The procedure can be carried out also of capillary and/or needle in the event obstructed
9.1.2.6 WASHING PROCEDURE IN CASE OF USE OF LATEX CONTROLS
If the instrument is controlled using Latex Control Kit, this procedure MUST be done every time
latex controls are used.
At the beginning of each Latex Controls session:
distilled water in positions 1 and 2 of the rotor
Execute a second washing selecting “Wash” then option “Internal ” and to load in position a 1 test-
tube filled up ¾ with sodium hypochlorite (diluted at 5%), while in position 2, a test-tube filled up ¾
with distilled water.
Now is possible to execute the Latex Control session. Choose the option “Standard” located inside
“Main” menu. Load in position a 1 test-tube filled up ¾ with distilled water, then the three latex-
tubes and the others two tests-tube filled up for ¾ with distilled water following the instructions
indicated on the screen.
At the end of the working day:

Prepare 3 tests-tube filled up ¾ with distilled water (eventually the third test-tube can contain a
liquid detergent).
Select the option “Wash and Sleep” located inside “Main” menu, then option “Internal” (if the
external withdrawing tip has been used, select “External” ), and follow the instructions shown on
the screen.
After have removed tests-tube from positions 1 and 2, the instrument, independently from its
configuration (Roller 10, Roller 10PN or Roller 20PN), requires to load the third test-tube always
with distilled water (or liquid detergent) in position 1. From this test-tube it will be windrowed
approximately 1/3 of the content, then the instrument will stop the pump leaving the needle inside
the test-tube and it will ask to switch OFF.
9.1.2.7 – END OF WORKING DAY WASHING PROCEDURE (Wash and Sleep)
This option is used at the end of the working day and offers the possibility to maintain the capillary moist
overnight. This is useful because all the hydraulic circuitry remains filled with water or with detergent (CBC
detergent).
The advantage of this procedure is that all residual blood particles that eventually have remained inside the
capillary, are kept moist avoiding them to remain stuck over the internal capillary walls.
Wash and Sleep:

To activate the procedure select “Wash and Sleep” from the MAIN MENU,the instrument asks to select the
tipology of desired washing:
This option is available ONLY in Roller 20PN configuration (chapter 9.1.2.3)
Selecting the “Internal”, the instrument requires the insertion of two tests-tube(in position 1 and 2 of the rotor) filled
up 3/4 with distilled water and then active the washing procedure.
If for any reason the washing procedure reports “PHOTOMETER NOT OK” means that the washing cycle has not
been executed correctly.
procedure.
In the second step, independently from the typology of chosen wash (Internal, Automatic or External), the
instrument after have printed out the result of washing procedure, will requires to remove both tests-tube, only if
the instrument is Roller 10 or Roller 10PN, while for the Roller 20 PN will require it ONLY if the “Internal” washing
has been chosen. After have removed the tests-tube from positions 1 and 2, the instrument, independently from
its configuration, requires the insertion of an ulterior test-tube always with distilled water (or cbc liquid detergent) in
position 1. From this test-tube it will windrow approximately 1/3 of the content, then the instrument will stop the
pump leaving the needle inside the test-tube and it will ask to switch OFF the instrument.
This system maintains all the hydraulic circuit filled with water (or cbc detergent) and avoids that eventual residual
particles of blood dries and stick to the inner wall of the capillary.
At the next switch ON the instrument will empty the residual water from the capillary and will ask to remove the
test-tube.
If the third test-tube had been filled up with liquid detergent, an ulterior washing must be executed using 2
tests-tube filled up ¾ with distilled water; this washing is used to remove completely all the residual detergent
liquid before beginning a new analytical session.
The procedure of washing with 3 tests-tube MUST BE EXECUTED at the end of each working day in order to
guarantee a good and efficient maintenance of the instrument.
9.1.2.8 – WASHING ERRORS
not been executed correctly or has been found anomalies in the system.
The possible causes of malfunctioning can be:
It has been inserted an empty WASH tube,

One or both tube are missing
Washing reference level lower than 2500
Washing reference level inside the range (2500 – 4000) but not detected sample’s end
Washing reference level higher than 4095
Detected air bubbles during the washing procedure
Washing tank empty
9.1.3 – STANDARD (Latex control / calibration)
PRINCIPLE OF METHOD
The Control kit is based on the use of three samples with known turbidity values, on which the analyzer performs
transmittance measurements related to ESR values. The results obtained should fit the expected ranges.
Otherwise the calibration of the instrument shall be verified.
Please refer to chapter 9.1.6 for quality control and statistical tools.

liquid detergent).
the screen.
Pressing “Standard” (from Main Menu) the instrument will set itself to be ready to perform a control or
calibration using Latex Controls.
If latex Calibrators are loaded, instrument will require to login as Technical User otherwise it will not
allow to continue with the calibration process.
The instrument will ask to insert respecting the sequence:

• 1 tube filled ¾ with distilled water
• 1 tube “tube 2” of Latex control previous identification by EBCR or typing manually the number printed below the bar
code
code
code
• 2 tubes filled ¾ with distillated water
The instrument will check:
• If the Latex expiration date has been passed, in this case it will withdraw the content of the 3 latex tubes
without performing the control or calibration
• if the three tubes belongs to the same kit, if not will tell the inserted codes are inconsistent, in that case
press “Clear” and the instrument will ask to remove the tubes.
• if more than 5 weeks has passed after the first piercing date of the inserted triplet, in this case it will
withdraw the content of the 3 latex tubes without performing the control or calibration
• if the loaded triplet has been used more than 6 times, in this case it will withdraw the content of the 3 latex
tubes without performing the control or calibration
If all checks are ok, it will begin the control procedure.
At the end, if everything went ok, the instrument will printout the control/calibration results in the following
sequence:
1. Reference levels (the same printed on the label stuck on the latex control/calibrator box)
2. Read level, will display the three latex levers read by each one of the two sensor
3. Now the instrument (If the latex are Calibrators) asks to set (just press “SET” option on the
screen) the new reference levels
4. The instrument will display again the reference values (the same printed on the label stuck on the latex
control/calibrator box) and new values got by the CPS unit after the calibration.
5. All the previous information is also printed out.
6. Press back.
7. The instrument will ask to remove, one by one, the tubes used during calibration/control.
This image shows a printed report after a Calibration, as is possible see it is divided in 4 main parts:
Part 1:
Washing sequence, were the instrument make a wash of the hydraulic circuit to
remove all possible residual blood particles and then reads “water reference”
Part 2:
Latex Calibration / Control labels read by External Bar Code Reader or inserted
typing manually
Part 3:
In this part the instrument printout the previous settings (only during Calibration)
Part 4:
In this part the instrument printout the result get after the Calibration / Control
procedure
Latex calibrators/controls are tested and measured using a STANDARD PHOTOMETER, this means that using
calibration latex, the values obtained (MFact1 and MFact2) guaranties that an instrument is perfectly aligned
with all the other instruments around the world because all the latex controls are referred to a STANDARD
PHOTOMETER measure.
In other words, a blood sample analyzed in one instrument will have the same result in another instrument
located in any other lab around the world if that instrument was also calibrated using latex.
1. Suggested option
Work with the latex reference (MFact) BoosterY MUST be set to 1.000. In this way the instrument is
perfectly aligned and works in standard mode, that means all the ESR values will be calculated using the
value obtained by latex calibration which is aligned with the STANDARD PHOTOMETER measure.
2. Work without latex reference, in this case the MFact’s obtained with calibration are still used as a method to
keep under control the instrument, BUT the BoosterY value IS NOT SET to 1.000, in fact, the laboratory will
increase or decrease manually the reference value and will setup the BoosterY based on its historical
data. In this case the equipment will work OUT OF STANDARD because it is aligned to the laboratory’s
historic data and not aligned to the STANDARD PHOTOMETER measure.
Even if the second option is chosen, each time the instrument run the Latex Controls, the reading unit is in any
case kept under control even considering the instrument works OUT OF STANDARD. In any case consider
that the Latex Control procedure runs considering the MFact value as its reference.
When the instrument is calibrated using latex calibrators and BoosterY has been set to 1.000 (option 1), could
be that the new ESR values (compared with the ESR values obtained before the calibration) will be constantly:
higher or lower
• HIGHER means the instrument overestimates the ESR (compared with previous laboratory’s historical
data)
• LOWER means the instrument underestimates the ESR (compared with previous laboratory’s historical
data)
But in both cases the instrument works fine (according to the calibration values obtained by latex because the
instrument is perfectly aligned with the STANDARD PHOTOMETER measure).
The three ESR resulting values should fit the ranges reported both on the print itself (“Reference values”) and on
the outer label in the table “REFERENCE VALUES”.
In case the obtained values after control keep staying outside the expected ranges it will be necessary to check
the instrument hardware. In this case please call the Technical Service to check the instrument performances.
9.1.3.a – BoosterY calculation
In order to have a calibrated instrument and, at the same time, ESR results that are correlated with the
laboratory’s historical data it is necessary to understand very well the following explications.
Option 1: Set BoosterY = 1,000 Option 2: Set BoosterY ≠ 1,000
Latex Calibration gives a new MFact Latex Calibration gives a new MFact
Set BoosterY = 1 Let’s say BoosterY = BY1
Let’s say BoosterY = BY1 Historical lab’s data says the new ESR values are
overestimated compared to the previous ESR results.
New ESR results are correlated with historical In this case it is necessary to modify BoosterY
laboratory’s data.
In this case everything is ok and works fine, no further Now to have a better understanding we will use numeric
modifications are required examples:
Let’s say MFact = 1.200 (obtained by calibration)
Let’s say MFact = MF1 = 1.200

(*) suppose that 1.100 is a value set according to
the laboratory’s operator’s experience or by We said that BoosterY ≠ 1
calculating the Alignment Factor.
Let’s say BoosterY = BY1 = 1.100 (*)
More analysis are done and the results are correlated to

 n ESRi exp ected 
AF =  ∑  the historic data, and everything is ok
 i =1 ESRi obtained  On the same way if the results after the calibration are
underestimated it is necessary to increase the
Where i = samples analyzed
BoosterY, taking always as reference the MFact value.
In this case BoosterY will be set to the AF value
With this is possible to get the ESR results correlated to
the historical laboratory’s data
Here follows a graphic example that show how to apply the AF correction:
Lab STD 30 12 18 12
Lab STD After Latex with BY = 31 53 72 49
ESR Calibration Adjust
32 90 120 81
Factor
33 68 91 62
Mfact xx 1,2627 1,2627 34 2 4 3
BY yy 1,000 0,6743 35 5 8 5
1 3 5 4 36 10 15 10
2 20 29 19 37 24 34 23
3 36 50 34 38 56 76 51
4 75 101 68 39 78 104 70
5 20 29 19 40 54 73 49
6 25 35 24 41 84 112 76
7 6 10 6 42 12 18 12
8 2 4 3 43 23 33 22
9 2 4 3 44 35 48 33
10 3 5 4 45 7 11 7
11 4 7 5 46 43 59 40
12 53 72 49 47 78 104 70
13 20 29 19 48 54 73 49
14 12 18 12 49 10 15 10
15 10 15 10 50 2 4 3
16 6 10 6 51 3 5 4
17 2 4 3 52 6 10 6
18 3 5 4 53 76 102 69
19 5 8 5 54 89 119 80
20 8 12 8 55 53 72 49
21 11 16 11 56 21 30 20
22 20 29 19 57 24 34 23
23 35 48 33 58 12 18 12
24 36 50 34 59 25 35 24
25 45 62 41 60 15 22 15
26 24 34 23 61 2 4 3
27 3 5 4 62 9 14 9
28 5 8 5 63 11 16 11
29 65 88 59 64 13 19 13

Where:
o Lab STD ESR are the ESR results before capillary replace and calibration using latex.
o After Calibration are the ESR results of the same samples but with MFact obtained by calibration
procedures and BY =1,000
o Lab STD with BY = Adjust Factor are the ESR results of the same samples after have modified the
BoosterY with the value obtained applying the AF formula.
Using the Adjust Factor method is possible to obtain a quite good match between Lab’s standard results and
the result obtained by Roller10.
The following graph shows the correlation between column 2 and 4
ESR Comparison before and after Latex calibration,

adjusted applying Adjust Factor, to match the previous
Laboratory's Values
90
y = 0,8907x + 1,1802
80
R 2 = 0,9999
70
60
50 Serie1
40 Lineare (Serie1)
30
20
10
0
0 20 40 60 80 100
It’s important remember that, even if the instrument’s MFact and BoosterY are different, in any way, every time
the Latex Control is used, the instrument will be checked up using the MFact reference, this means the
BoosterY value will not be influent in the Latex procedures.
Other important thing to remember is that with BoosterY different from MFact, the instrument will work out of
standard (according to the Latex Calibration/Control) but will work fine according to the Lab’s
standards.
To change BoosterY’s value please refer to chapter 9.2.1.1.a
9.1.4 – MIXER
By pressing “Mixer”, (from Main Menu or from Main Screen) the instrument will activate the mixing function that
will do the samples mixing without any analysis.
This function becomes useful if a haematology mixer is not available during the comparative proofs between the
instrument and the method used in laboratory. The inserted samples are mixed performing the same number of
rotations programmed for the analysis, and then are kept mixed through a 3 rotations each 5 seconds up to the
pressure “Back”, the instrument will ask to remove all inserted tubes, checking one by one they has been
removed from the rotor, at the last tube remotion, it will display the MAIN SCREEN
Pressing “Clear” is possible to abort the procedure, in this case the instrument will ask to remove all inserted
tubes, checking one by one they has been removed from the rotor, at the last tube remotion, it will display the
MAIN SCREEN
9.1.5 – EMPTY ROLLER
By pressing “Empty Roller”, (from Main Menu or Main Screen) the instrument will allow to remove all inserted
tubes, checking one by one they has been removed from the rotor.
9.1.6 – INTERNAL QUALITY CONTROL
The ROLLER 10 family analyser provides a series of control tools for an effective product performances
monitoring; such control tools are the following:
1. Photometrical check done during each washing.
2. Statistical daily control, that uses as reference population the same samples analyzed during the last 30
days, till a maximum of 6000 data. There are possible four different printouts, that report the control on all
the range of the results (from 2 to 120 mm/h) or only those relative to results considered normal (AON -
Average Of Normal - from 2 to 30 mm/h).The explanation of such controls is detailed in the chapter
"Presentations of statistical data".
3. The ESR determination is susceptible to several variables (temperature, performing, sample state, results
reading).
Since the phenomenon of erythrocyte sedimentation is confined to fresh blood and is transient, quality
control procedures are based on the comparison of the results with the reference method performed on
fresh samples. According to these remarks, the traditional control materials are not able to reproduce
correctly the phenomenon.
For laboratory quality control it is then important to have at disposal a control system reproducible and
easy to handle. This system is available using a Latex Control kit (Ord. code SI 305.100-A/SI 305.102-A or
SI 305.300-A/ SI 305.302-A) that was designed expressly for TEST1 family (TEST1, MicroTEST1, Roller20)
and now also for ROLLER 10 family (Roller 10, Roller 10 Plus Needle, Roller 20 Roller 20 Plus Needle). Refer
to chapter 9.1.3 for latex control procedures.
Pressing “Q.C.”, (from Main Menu) the instrument will display the following image
The instrument collects data from:

• Washing procedures
• ESR statistical analysis classified by:
a) average, cumulative and daily distribution on the “Global” range (ESR from 2 to 120)
b) average, cumulative and daily distribution on the “Normal” range (ESR from 2 to 30)
• Latex Control results
• Washing procedures
9.1.6.1 – WASHING QUALITY CONTROL PRINTOUT - Graph meaning
This function allows to printout statistical data about the washings (independently they are Internal, External or
Automatic) executed on the instrument:
The printout of the washing control allows to estimate the efficiency of the photometer. The diagram visualizes the
trend of washing values detected by the three sensors, which are directly correlated to the photometric signal.
Normally, the instruments are regulated automatically around to an absolute value of 3800 during the washing with
distilled water. This value tends to move down during the time, because of the residues of biological material
inside the capillary.
Pressing “Print (5-1)” activates the printout that represents the behaviour and the tendency of the photometric
values correspondents to the values of the water.
Come si può vedere dal grafico sottostante, lo strumento mostra la tendenza degli ultimi 30 giorni, da cui si può
facilmente individuare eventuali derive o comportamenti anomali.
Explanation and interpretation of the diagram:
References of the sensors: 1, 2 and stop

Lower and Upper limits of water acceptability, ideal reference is 3800.
This indication that identify the instrument has been switched

ON, not used and switched OFF
This indication identify that the instrument has been switched

ON, used and then switched OFF without have been washed
This indication means that the instrument has been washed and the
three sensors has detected a water value included within the lower
and higher limits:
sensor 1: 3757
sensor 2: 3770
stop sensor: 3829
On the graphical print out, the instrument prints always the last
washing executed in the day, independently from how many had been
effectively is executed. In case more washings had been done during
the same day, the data is overwritten. At midnight (change of the day),
the instrument memorizes definitively the data of the last wash; that
data is the one printed out.
In the lower part of the report is printed out the statistical data about
the last 30 days;_ this means, for every sensor: the average and the
SD of the period. The most important thing is that the three averages
remain as close as possible to 3800 which is the reference value.
Executing the washings as described in below will help to maintain photometrical signals close to an absolute
value of 3800.

liquid detergent).
the screen.
If the photometrical signals fall under a value of 3600 or rises above a value of 4000, the instrument will generate
“PHOTOMETER NOT OK” error and will suggest ti retry the washing procedure. In this case, eventually is
possible to try the maintenance washing. If the value does not come again inside the range call the technical
service.
9.1.6.2 – “NORMAL” ESR AVERAGE CONTROL PRINTOUT - Graph meaning
This option prints out the statistical data relative to the ESR average values grouped under:
• average on the “Normal” range (ESR from 2 to 30)

• average on the “Global” range (ESR from 2 to 120)
Pressing “Normal (1-1)” will be activate the graph printout that representing the behaviour of normal average
values
The population referring to the lab should have, on an average, the same kind of patients and consequently the
mean ESR value for this lab and the ESR distribution should remain constant. This is particularly significant with
increasing the samples considered daily. If all ESR data are considered together, since 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).
Comparing the daily mean ESR value for all patients with the cumulative mean ESR value, the reliability of the
instrument can be evaluated. What can be expected is that the daily mean ESR value oscillates around the more
stable cumulative mean ESR value, which represents the reference.
The graphical plot can be used to evidence eventual systemic drifts from the cumulative mean ESR value. In this
case a problem of instrument reliability can be suspected.
Explanation of the diagram: Printout of the averages reported to

the interval of normality (from 2 to 30 mm/h)
Number of sample analyzes in the day, that falls inside in the interval of normality
Lower and Upper acceptability limits
5 15 25 limits: from 2 to 30
|-----|-----|-----|-----|-----|
8.88 ● black dot is the progressive average
4.11 o white dot is the average of day 1
6.69 ● progressive average (day 1 + day 2)
7.14 ● progressive average (day 1 + day 2 + day 3)
Data belonging today’s analysis
In the lower part of the plot, are reported the values of daily and progressive
average and SD:
STD o 2.85 19 corresponds to the daily SD, while the number to
side (19) means the samples analyzed “this day” that falls in the limit 2 - 30.
STD ● 0.83 30 corresponds to the progressive SD, while the
number to side (1807) means the samples analyzed “in the last 30 days
that falls in the limit 2 – 30. Limits >5 and <10 indicate that the progressive
average is between 5 and 10.
The stability with time of the mean value of “normal population” is not affected 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.
9.1.6.3 – “GLOBAL” ESR AVERAGE CONTROL PRINTOUT - Graph meaning
This option prints out the statistical data relative to the ESR average values grouped under:
• average on the “Normal” range (ESR from 2 to 30)

• average on the “Global” range (ESR from 2 to 120)
Pressing “Global (1-2)” will be activate the graph printout that representing the behaviour of global average
values
Explanation of the diagram: Printout of the averages reported to

global range (from 2 to 120 mm/h)
Like as explained for the interval 2-30, the same considerations can also be
applied for the interval 2-120
Number of samples, analyzed in the day, that falls inside the global range
Lower and Upper acceptability limits
5 15 25
|-----|-----|-----|-----|-----|
In the lower part of the plot, are reported the values of daily and progressive
average and SD:
STD o 4.31 20 corresponds to the daily SD, while the number to
side (20) means the samples analyzed “this day” that falls in the limit 2 -
120.
STD ● 1.34 1807 corresponds to the progressive SD, while the
number to side (1807) means the samples analyzed “in the last 30 days.
Limits >5 and <13 indicate that the progressive average is between 5 and
10.
Even if the two diagrams, apparently looks equal, the fact that in this diagram
are considered ALL the samples in the interval 2-120, means this diagram is
more sensible to variations, in fact comparing the statistical data of trend the 2-
30 and trend the 2-120is possible to notice the differences.
Guide to the interpretation of the diagram and statistical/clinical meaning
What reported on the previous pages still more meaningful if referred to the “normal population” if referred to the
stability, along the time, of the average of the ESR values in the normality range. The average ESR and
distribution of the normal values is without doubt more stable than the average and the distribution of the global
values, because in the global case are considered all the patients day after day can come from various ward
units, from particular ward units etc. It must also be remembered that the patients with ESR values in the normal
range are also, of usual, the majority of the samples who reach the laboratory.
This option must be considered like an analytical control based “on the population of the samples „ and it
presupposes the role of the control of the instrument. This kind of control can be considered like a continuous
calibration of the instrument.
For a sufficient number of samples, it can be always considered that in a laboratory with the same instrument, the
distribution of the ESR values and the average ESR value, should not oscillate in a meaningful way, if the
analytical performances of the instrument are sure.
It is reasonable think that in general terms the samples who arrive in the same laboratory, represent a constant
population that refers to the laboratory and that this population will maintain a constancy distribution of the ESR
values, especially if the number of samples considered you is statistically meaningful. The mean value of the ESR
of the population, therefore like the ESR distribution, can be used like “standard„ in order to control the reliability
of the instrument.
9.1.6.3.b – INTERPRETATION OF THE STATISTICAL MEANING
Interpreting the statistical printout of the data.
Data that belong to 30ts day
The printout corresponds to the mean and progressive ESR that is obtained selecting
from the Main Menù, the option Q.C. and then the pressing “Normal”
The trend of the behaviour of the daily average progressive ESR of all the samples will be
similar to that one shown to side:
(1-1) Daily samples inside the range 2 - 30
5 15 25
|-----|-----|-----|-----|-----|
This graphical printout represents the last 30 days of analysis, and an anomalous
tendency of daily average respect the cumulative average, can be easily evidenced, thus
alerting the user for a possible systemic error or instrument problem. The data are shown
from oldest (on the top) to most recent (on bottom of graph).
Be careful in interpreting the data to consider the number of samples of the day and an
eventual different source of samples. The cumulative average line becomes stable
after a certain point (more than 100 samples) and the daily average moves around the
cumulative trend line. In this way a problem on instrument could be immediately
evidenced by a rapid deflection of the trend line of daily and cumulative averages.
The instrument is able to collect 6000 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 6000 samples, it will discard the first 1000
(using the FIFO rule), coming back to 5000 samples to avoid that the cumulative average
trend becomes too much stable to be moved.
At the end of the graph, the Standard Deviations of cumulative average and daily average
are printed:
STD o 2.85 19 corresponds to the daily SD, while the number to side (19)
means the samples analyzed “this day” that falls in the limit 2 - 30.
STD ● 0.83 30 corresponds to the progressive SD, while the number to side
(1807) means the samples analyzed “in the last 30 days that falls in the limit 2 –
30. Limits >5 and <10 indicate that the progressive average is between 5 and 10.
From a statistical point of view, 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 (7.58) and the three standard deviations of the daily average (2.85 x 3 =
8.55), we can say that the last daily average is in range if don't exceeds the three standard deviations of the cumulative data.
In this example, the lower limit it will be 7.58 – 8.55 = abs(-0,97), in other word 1, and the upper limit it will be 7.58 + 8.55 =
16.13. In this case, the daily value 8.55 falls between the lower and upper limits, so the instrument is working properly.
Remember that if this doesn't happen, the cause should be searched on the samples processed during the day and from the
kind of patients analyzed (a lot of pathological or a lot of healthy patients). This first graph is referred to all the ESR results
from 2 to 30, and this data can be highly instable. For this reason, also the next graph is printed out.
.
This according to plot look identical to the previous one, but in this case the
analysis covers the entire ESR results comprised between 2 - 120, this means the
GLOBAL range of values.
This plot is slightly less stable, because data that compose it includes also the
pathological patients.
As is possible to see, even without changing the total data analyzed, the diagram
is slightly less stable because in this case appears average data that tends to
move upwards the daily ESR average and consequently also the daily and
progressive SD raises.
This is corroborated also from the fact that the upper limit goes from <10 to <13
and the SD increases respective from 2.85 to 4.31 (daily) and from 0.83 to 1.84
(progressive)
9.1.6.4 – “NORMAL” CUMULATIVE ESR DISTRIBUTION PRINTOUT - Graph meaning
This option prints out the statistical data relative to the cumulative ESR values grouped under:
• cumulative on the “Normal” range (ESR from 2 to 30)

• cumulative on the “Global” range (ESR from 2 to 120)
Pressing “Normal (2-1)” will be activate the graph printout that representing the behaviour of normal cumulative
values
Interpretation of the diagram: Printout of the normal cumulative

ESR distribution (from 2 to 30 mm/h)
Total Number of samples, inside the normality interval
Statistical data: Average and SD of the data analyzed.

The mean and SD values refers to the data in the interval 2-30.
As it can be seen, the instrument generates a statistical report in which the ESR
results are redistributes in subintervals (of the normal interval 2-30)
For each subinterval is available:

limits of the interval
percentage of samples in each interval
number of samples analyzed that belong to each subinterval
9.1.6.5 – “GLOBAL” CUMULATIVE ESR DISTRIBUTION PRINTOUT - Graph meaning
This option prints out the statistical data relative to the cumulative ESR values grouped under:
• cumulative on the “Normal” range (ESR from 2 to 30)

• cumulative on the “Global” range (ESR from 2 to 120)
Pressing “Global (2-1)” will be activate the graph printout that representing the behaviour of global cumulative
values
Interpretation of the diagram: Printout of the global cumulative

ESR distribution (from 2 to 120 mm/h)
Total Number of samples, inside the “global” interval


It is important to notice that in “Global” distribution the intervals do not match

the intervals defined for the “Normal” distribution neither in number of samples,
in fact it’s natural expecting that the total number of samples analyzed will be
higher than those considered in the “Normal” distribution, because in the global
distribution are considered all the samples between 2 and 120, while in the
normal distribution only the samples between 2 and 30
9.1.6.6 – “NORMAL” DAILY ESR DISTRIBUTION PRINTOUT - Graph meaning
This option prints out the statistical data relative to the daily ESR distribution values grouped under:
• daily on the “Normal” range (ESR from 2 to 30)

• daily on the “Global” range (ESR from 2 to 120)
Pressing “Normal (3-1)” will be activate the graph printout that representing the behaviour of normal values
Interpretation of the diagram: Printout of the normal daily ESR

distribution (from 2 to 30 mm/h)
Daily samples, inside the normality interval


9.1.6.7 – “GLOBAL” DAILY ESR DISTRIBUTION PRINTOUT - Graph meaning
This option prints out the statistical data relative to the daily ESR distribution values grouped under:
• daily on the “Normal” range (ESR from 2 to 30)

• daily on the “Global” range (ESR from 2 to 120)
Pressing “Global (3-1)” will be activate the graph printout that representing the behaviour of normal values
Interpretation of the diagram: Printout of the global daily ESR

distribution (from 2 to 120 mm/h)
Daily samples, inside the global interval


The distribution of ESR values in the population referring to the same

laboratory, especially the distribution of ESR values within the normal range
can be assumed to be constant with time. This is true when the number of
samples considered is statistically significant.
With this check it is easy to explain an eventual oscillation of the daily mean
ESR value, which could alert the technician. This variation can be due to a
casual variation in the number of pathological samples coming from
particular wards.
If the distribution of ESR values of the day is considered, it can be easily seen that the distribution in the medium
to high values can be varied, while the distribution within the normal range is 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, then
higher the number of samples the lower the variations compared to the cumulative parameters.
9.1.6.8 –INSTRUMENT VERIFICATION USING THE LATEX CONTROL KIT
The Latex Controls kit (Ord. code SI 305.100-A/SI 305.102-A or SI 305.300-A/ SI 305.302-A) is a valid tool for the
functional verification of the analyser Roller 10. The results of the control simulate three ESR values, a first level
(around 5 mm/h), one intermediate level (around 20 mm/h) and a high level (around 60mm/h). By comparing the
results obtained from the analyzer with those reported on the kit package it will be very easy to control if the
instrument is reporting reliable results or not. In this way, the instrument can be kept monitored during its whole
operational life.
Before of the execution of the latex controls, the instrument demands a washing procedure using two washing
tubes filled ¾ with distilled water as described in previous chapters.
It is necessary to follow the instructions for use included into the Latex Controls kit and at the end of the
procedure compare the printed results from the analyzer against the values reported in Table 2 on the package kit
box: if the results obtained by analyser fits the expected range reported on Table 2 , it means that the analyzer is
calibrated.
On the contrary, if one or more results are different from the ones reported on the kit package, it is recommended
to call the Technical Service for a functional verification and calibration of the apparatus.
Below is reported the procedure used to check instrument using Latex Control kit

liquid detergent).
the screen.
Results obtained during the latex control

procedure are stored by the instrument; it is
therefore possible to print out a report pressing
the key “Print( 4-1)”. With this option it is
possible to visualize the tendency of the
instrument and being able to find eventual drifts
that will require an accurate control of the
instrument. The graphical printout cover the last
30 days.
The trend of the latex must be interpreted as a tendency pointer.
The starting reference are the values obtained during the calibration and
then, for every control executed with the Latex Kit, the trend will show how
much the read latex values drifts from the reference values printed on the
box and also on the printout report generated during each control procedure.
Analyzing the diagram it is possible to observe that:
For each sensor there is a reference marker which represents the drift from
the reference (1) obtained from the analyzer against the reference values.
This trend, when is completely full, represents a maximum of 30 days of

analysis, therefore anomalous tendency in the daily values, against the
reference is easily identifiable. Consequently the customer is able to
understand if there is systematic error or an instrument error. Data are
shown from the oldest (lower part) to the most recent (upper part of the
diagram).
Explication of the printout report:
In order to better understand the meaning of the results

-20 -10 1 +10 +20 printed out, imagine a series of three controls with values of
DEV% |----------|----------|----------|----------|
| | | ● | | 5, 20 and 60 mm/h (values of reference). Executing the
| | | o | | control of the analyzer, if the values will be identical (5, 20
| | |● | | and 60 that is the ideal case), there won't be a shift (y=1.00*x)
| | o* | | and the dots symbol will printed exactly on the column 1, as on
| | |● | | line 4 on the aside graph. On the contrary, if the results are for
| | | o | | example 6, 22 and 64 mm/h, the shift would be +5,36%
| | |● | | (y=1.0536*x) and the dots will be positioned between column 1
| | o | | and column +10%, like the first black dot in the graph aside.
| | | ● | | At the bottom are printed out Standard Deviation (SD.) and the
| | |o | | Percentage Coefficient of Variation (CV%).
If the CV% remains under +/- 10% it means that the analyzer
Sens ● Dev. St. 6,15 CV% = 8,05 does perform efficiently. If the CV% exceeds the above limits a
Sens o Dev. St. 5,15 CV% = 7,05 revision of the analyzer calibration by the technical service is
recommended.
In order to explain as the value of 5.36% is obtained, it is necessary to make a small graph to be able to relate the
numbers indicated in the example reported in the manual.
Values of reference Obtained values Average 30,67
5 6 Std. Dev. 26,15
20 22
60 64
The column “Obtained values” contains the values obtained after to have carried out a cycle of control or
calibration.
In the plot appear two lines of tendency:

Blue (reference) it is generated by values 5, 20 and 60 and the straight line is its corresponding
regression
Red (obtained) it is generated by values 6, 22 and 64 and the straight line is its corresponding
regression.
How interpretate the equation of the second straight line y = 1,0536x + 0,8144?
Value 1.0536 that is 5.36% indicates that the instrument has a slightly superior gain compared with the
ideal values (y = 1,000x).
The second value (0,8144) is the value where the straight line crosses the Y axes.
Software uses also this value to obtain a more accurate calibration of the measurement unit since it allows to
compensate possible small imperfections of the capillary.
It is clear that to each group of three values belongs a straight line associated by making a linear regression; in
this way every time a control or calibration takes place, the equipment calculates a straight line and with the
collected data updates the tendency plots that are printed out.
9.1.6.9 – ERASE STATISTICAL DATABASE
To erase statistical database, it is necessary to be logged as Technical User
To login is necessary to access Setup and “Log In-out”, then press “LOGIN”
and type the appropriate password (1990 for technical level).
press the “LEFT ARROW” and then “BACK”. On the MAIN SCREEN will be indicated the level of login: User or
Technical level”.
Then from Main Menu select “Q.C.”, the instrument will display the following image
Now just press “Res.” To erase desired statistical database. Each database is independent so, to erase all
database it is necessary to press “Res.“ for each one of them.
At the end press “Back” to return to main menu.
9.2 – SETUP MENU
Setup Menu:
Pressing “Setup” from the MAIN SCREEN, the instrument shows the following options
9.2.1 – CPS MENU
CPS:
This function’s accessibility is linked to a password level.
Pressing “CPS” (in the Setup Menu) without any password level activated, the instrument will display:
9.2.1.1 – CPS’ PARAMETERS
then pressing “Parameters” will be displayed CPS’s parameter but without the possibility to modify anything as
showed in the next image:
9.2.1.1.a – MODIFY BOOSTERY’s VALUE
As stated before, to have the possibility to modify these parameters it is necessary to be logged as “user level”
(with limited access) or as “technical level” (with full access to the functions) otherwise the instrument will not
allow to access the function.
To login is necessary to access Setup and “Log In-out”, then press “LOGIN” and type the appropriate
password (1010 for user level; 1990 for technical level).
press the “LEFT ARROW” and then “BACK”. On the MAIN SCREEN will be indicated the level of login: User or
Technical level”.
User level allow only to modify BoosterY value.
Pressing “SET” the instrument allow to modify BoosterY’s value according to local Lab’s references or
Westergren references.
To modify just type the desired value
then press the “left arrow” to confirm or “Clear” to exit without change anything, the instrument will display
again the previous image with the BoosterY’s new value. Pressing “Back” is possible to go back to MAIN
SCREEN.
9.2.1.1.b – MODIFY WHOLE PARAMETRES’ VALUES (Technical password required)
Once logged as Technical Service is possible to modify all CPS setup value
IT IS VERY IMPORTANT TO UNDERSTAND THAT MODIFYING ONE OR MORE OF THIS PARAMETERS

CAN AFFECT INSTRUMENT’S PERFORMANCES AND CAN CAUSE AN INCORRECT BLOOD ANALYSIS
RESULTS.
TECHNICIANS THAT MODIFY THIS PARAMETERS MUST KNOW VERY WELL THE FUNCTIONALITY OF
EACH ONE OF THESE PARAMETERS.
IN ANY CASE IS STRONGLY RECOMMENDED TO PRINTOUT A FLAG LIST BEFORE DOING ANY
VARIATION ON THIS OPERATIVE PARAMETERS.
9.2.1.1.c – MODIFY MODEL FACT’s VALUES
To modify each one of the two ModelFact values press “SET” to access each one of the parameters configuration
page, where is possible so set manually the desired value. As explained before, numbers are typed using the
keyboard.
again the previous image with the new Model Fact value. Pressing “Back” is possible to go back to MAIN
SCREEN.
9.2.1.1.d – MODIFY Offset Sensors VALUES
To modify each one of the two Offset sensors values press “SET” to access each one of the parameters
configuration page, where is possible so set manually the desired value. As explained before, numbers are typed
using the keyboard.
In this case, due to the Offset can be positive or negative, first type the number and then press +/- if you need a
negative reference, then press the “left arrow” to confirm or “Clear” to exit without change anything, the
instrument will display again the previous image with the new Offset value. Pressing “Back” is possible to go
back to MAIN SCREEN.
9.2.1.1.e – MODIFY THERMOSTAT reference value
To modify thermostat sensor reference value sensors values press “SET” to access configuration page, where is
possible so set manually the desired temperature. As explained before, numbers are typed using the keyboard.
again the previous image with the new Model Fact value. Pressing “Back” is possible to go back to MAIN
SCREEN.
9.2.1.2 – CPS Read ADC
This function allow technician to verify CPS’s Analog-Digital Converters reference (without the possibility to
modify anything if not logged as technical service)
Pressing “Read ADC” will be displayed CPS’s Analog-Digital Converters reference (without the possibility to
modify anything if not logged as technical service).
DAC: which is changeable refers to the power emitted by the LED inside the reading unit. This value changes
every time a washing procedure is done and the change is adjusted in order to obtain a value of DAC which
guarantees a water value as close as possible to the ideal value of 3800. DAC reference number goes
from 0 to 1024 Normal working range goes from 350 to 600, ideal value is around 450
ADC: is not changeable and refers to the effective value that each sensor reads (in other words is the sensibility
of the sensor) , in this case this value changes continuously and each value is independent from the
others. ADC reference number goes from 0 to 4095. There is no specific working range even if the
ideal values is around 3800.
To modify DAC’s values proceed as described for the oters examples, for each sensor appears a keyboard in
which the technician can set the desired value. Values goes from 0 to 254.
9.2.1.3 – FIRST UP
Please refer to chapter 10

9.2.2 – MIX MENU
Pressing “Mix” (in the Setup Menu), the instrument will display:
this function allow the user to set:

• The desired number of rotations: pressing “set” the instrument will display a keyboard where the operator
can type the desired number of rotations (from 5 up to 1000), then pressing the “left arrow” confirm the
new value.
• The desired mixing speed: “low”, “med” or “high”; just press the desired speed “button”
• by default the instrument is set up at medium speed and 140 cycles
Finally the operator can check practically if the desired just done setup is ok by pressing “Go”, in this case the
rotor being to rotate and will still rotate up when the “Stop” is pressed.
Pressing “Back” the instrument will go back and will display the Main Screen
9.2.3 – DATE TIME MENU
Without a password
Pressing “Date time” (in the Setup Menu), the instrument will display:
9.2.3.1 – MODIFY DATE TIME VALUE (User level password required)
otherwise the instrument will not allow to access the function.
To login is necessary to access Setup and “Log In-out”, then press “LOGIN” and type this password: 1010,
press the “LEFT ARROW” and then “BACK”. On the MAIN SCREEN will be indicated “LOGIN: user level”.
User level allow to modify date and time values:
Pressing “SET” the instrument allow to modify DATE or TIME values;
• If the change is applied to DATE, the instrument will ask to modify in the following order: Year, Month and
Day to modify just type the desired value
• If the change is applied to TIME, the instrument will ask to modify in the following order: Hour, and Minute
to modify just type the desired value
again the previous image with the DATE or TIME new value. Pressing “Back” is possible to go back to MAIN
SCREEN.
9.2.4 – FL (Flag List) MENU
Pressing “FL” (in the Setup Menu), the instrument will

printout the Flag List:
In the Flag List are printed out all the operational

parameters of the instrument; the following image
extension the flag list of Roller 10
Date and time of

the software
compilation.
Instrument serial number

Whole analytical parameters printing activation (Only Technical Service)
Threshold level for Maintenance intervention requesting. (Only Technical Service) reference value:
30000
Counter test for Maintenance intervention
Threshold level for waste tank replacing (Only Technical Service) reference value is 3000
Threshold (in minutes) for automatic washing. (Only Technical Service) reference value 15
Enable patient ID and ESR results printing on real time
Enable the IDs and ESR results on double height printing
Test availability for the ESR and other parameters analysis
ESR and other parameters counter of executed test
Alarm threshold for tests

This parameter contains the name of the personalization owner
Motor Board Software version.

Date and time of the Motor Board software compilation.
Number of mixing revolutions, from 1 to 1000.
Mixing speed, 1=60 RPM (default), 2=32 RPM and 3=24 RPM
Analogical Board Software version.

Instrument Gain. values accepted between 0,6000 to 1,6000
Compensator factor to instrument calibration for Sensor 2
Latex gain factor Sensor 1, values accepted between 0,6000 to 1,4000 (Only Technical Service)
Latex gain factor Sensor 2, values accepted between 0,6000 to 1,4000 (Only Technical Service)
Compensator factor to instrument calibration for Sensor 1
Reading Unit temperature, values accepted between 20 to 40 (Only Technical Service)
Instrument switching off counter without washing procedure
Maximum value of washing water read and memorized for Sensor 1
Maximum value of washing water read and memorized for Sensor 2
Maximum value of washing water read and memorized for Stop Sensor
Water Reference Level for Sensor 1 (Only Technical Service) reference value 100 TO 160
Water Reference Level for Sensor 2 (Only Technical Service) reference value 100 TO 160
Water Reference Level for Stop Sensor (Only Technical Service) reference value 100 TO 160
Communication Board Software version.

Date and time of the Communication Board software compilation.
Serial communication protocol.
Analysis enabling for samples with patient ID not recognised.
Enable the extended waiting time to receiving “T” messages from Host
Enable (disable) Bayer protocol compatibility.
Timeout for Host waiting in serial interface
The instrument will/will not do the analysis if TIMEOUT event happens (Only Technical Service)
9.2.5 – SETTINGS MENU
Without a password is possible to access only few functions
Pressing “Settings” (in the Setup Menu), the instrument will display:
9.2.5.1 – SOFTWARE VERSION
This instrument uses 5 different processors to work, this means that not all of them necessarily have the same
or last version installed; to know which software version is installed in each processor press “SW version” the
instrument will display software version’s installed.
where XXX means the release of software. The

release is expressed by a letter from A up tp Z
Roller RELEASE: R10-01.XXX
Display Software Version
Interface Unit Board Software Version
Motor Board Software Version
Analogical Board Software Version
Communication Board Software Version
Pressing “Back” the instrument will display again the

Setting Menu screen
9.2.5.2 – PRINT EXPANDED
This function, if activated, allow to printout the IDs and ESR results on double height; to access the function press
“Print exp.” the instrument will display.
In this example the function is set to “YES”
Pressing “Back” the instrument will display again

the Setting Menu screen
9.2.5.3 – PRINT IN RUN
This function, if activated, allow to printout the IDs and ESR results after the corresponding sample analysis; to access
the function press “Print in run.” the instrument will
display.
In this example the function is set to “YES”
Pressing “Back” the instrument will display again

the Setting Menu screen
9.2.5.4 – LANGUAGE SETUP
This function, if activated, allow to setup the language in which will be displayed messages and warnings
Available languages are:

English
Italian
Spanish
French
Just press the desired language, in this case

English to setup the instrument in English
language
Pressing “Back” the instrument will display

again the Setting Menu screen
9.2.6 – SETTINGS MENU with “USER LEVEL” PASSWORD LEVEL ACCESS
To login as user level is necessary to access Setup and “Log In-out”, then press “LOGIN” and type 1010 as
password, then press the “LEFT ARROW” and then “BACK”. On the MAIN SCREEN will be indicated “LOGIN:
user level”.
User level allow also to modificate date and time set up of the instrument:
Now, pressing “Setup” in the main menu ands then

“Settings” (in the Setup Menu), the instrument
will display besides the previously activated
options, also the wash time option :
9.2.6.1 – WASH TIME
This option allows to modify the delay of time (in minutes) for the alarm activation for a washing procedure
requesting. The counter’s countdown starts at the end of the analysis cycle.
To access this function, press “Wash Time” (in the Setup Menu), the instrument will display:
To modify the waiting time, just type the desired value
again the previous image. Pressing “Back” is possible to go back to MAIN SCREEN.
9.2.7 – SETTINGS MENU with “TECHNICAL LEVEL” PASSWORD LEVEL ACCESS
As stated before, to have the possibility to modify these parameters it is necessary to be logged as “technical
level” otherwise the instrument will not allow to access the whole functions.
To login is necessary to access (from Main Screen) to Setup
To access this function, press “Log In - Out” (in the Setup Menu), the instrument will display:
pressing “LOGIN” the instrument will display a keyboard, type 1990 as password, then press the “left arrow” to
confirm or “Clear” to exit without change anything, in both cases, the instrument will display again the previous
image, then press “Back”.
Then, pressing “Settings” (in the Setup Menu), the instrument will display:
As is possible see, the tech level password allow to access the previously explained functions (SW version, Print
in run, Print exp, Wash time, Reset Maint) plus others which will be explained in the next pages.
Remember that from software version 1.00N the control system has been changed, threshold is not more
necessary to set up a threshold level alarm for the waste tank because:
• at every switch ON of the instrument
• at every washing procedure start-up
• at the beginning of every cycle of analysis
the instrument controls the level of liquid inside the
waste tank, using the peristaltic pump to aspire
from the tank. If the pump aspires material, the
reading unit detects the presence of the material
and blocks the operation of the instrument,
informing via display that the waste tank needs to
be emptied/replaced.
9.2.7.1 – INSTRUMENT SERIAL NUMBER
This option allows to modify the Instrument’s Serial Number.
To access this function, press “s.n.” (in the Setup Menu), the instrument will display a keyboard allowing to type
the desired serial number:
TYPE SERIAL
NUMBER
(1 – 9999 )
9.2.7.2 – DEBUG
This function, if activated, allow the instrument to print out useful information for the technical service personnel.
This information can also be required by SIRE Foreign Technical Service in order to help local technical service
solve eventually problems with the instrument.
to activate the function press “Debug” the instrument will display.
DEBUG
In this example the function is set to “YES”. Pressing “Back” the instrument will display again the Setting Menu
screen
9.2.7.3 – CONFIGURATION OF KIND OF ROLLER (Available from software version 1.00N)
This function, allow the Technical Service Personnel to “configure” the installed software according with the kind
of Roller it will be used in.
The software installed and also eventually software upgrades are designed to be fully compatible with the 3
typologies of Roller 10 available:
• Roller 10: the small one, with a capacity of 10 samples
• Roller 10 PN: the same as Roller 10 plus the manual external withdrawal tip for pediatric test-tubes or for
test tubes without rubber cap
• Roller 20 PN: with the capacity of 20 samples, equipped with an automatic washing system and manual
external withdrawal tip for pediatric test-tubes or for test tubes without rubber cap
to activate the function press “Kind Of R.” the instrument will display.
Then pressing the appropriate button, software will activate the functionalities corresponding to each type of
instrument according to the option chosen.
Pressing “Back” the instrument will display again the Setting Menu screen
9.2.7.4 – MAINTENANCE LEVEL RESET
This function, if activated, allows TO CANCEL the maintenance counter. This counter increases every time an
analysis is executed.
When the threshold of maintenance is reached up (by default is set to 30000), the instrument will begin to advise
the necessity of technical maintenance.
If for some reason the maintenance is made before of the 30000 tests, pressing “Reset Maint.” The counter will
be set again to 0
Pressing “Back” the instrument will display again the Setting Menu screen
9.2.7.5 – MAINTENANCE LEVEL THRESHOLD SETUP
This function, if activated, allows setup the maintenance counter warning threshold at whose level the
instrument will require the maintenance service. The threshold is set by default to 30000 test.
Pressing “Maintenance” the instrument will display a keyboard allowing to type the desired threshold warning
level:
9.2.7.6 – INSTRUMENT GENERAL RESET
This function, if activated, allows to RESET the instrument to the default parameter’s values.
Press “Reset” in order to access the reset function, the instrument will ask for confirmation before resetting the
instrument
Then just press YES or NO to activate or not the function; in this example the function is set to “YES”. Pressing
“Back” the instrument will display again the Setting Menu screen without have reset the instrument.
9.2.8 – LOG IN-OUT
nd rd
As stated before, the user will be required to type in a password to rise up from the 2 to the 3 level of the
instrument’s setup, otherwise the instrument will not allow to access the whole functions.
pressing “LOGIN” the instrument will display a keyboard to type the password, type the proper password, then
press the “left arrow” to confirm or “Clear” to exit without change anything, in both cases, the instrument will
display again the previous image, then press “Back”.
To Logout, access this function, press “Log In - Out” (in the Setup Menu), press “LOGOUT” the instrument
will return to level 0. Pressing “Back” is possible to go back to MAIN SCREEN.
Password levels:
level access
1 No password required, allow access only to the elementary functions
“LOGIN – USER LEVEL”:

2 allow access to the elementary setup functions. When the instrument is switched off, the instrument loose
this password, so next time the instrument is switched on it will be setup as level 1 user.
“LOGIN – TECH LEVEL”:

3
this level is only for Technical Service Personnel.
9.3 – AVAILABILITY MENU
Pressing “Availability” from the MAIN SCREEN, the instrument shows the following options
9.3.1 – WARNING LEVEL (User level password required)
To access this function it is necessary a password
Without a password
This function do not work without a password level and the instrument will display the following
message
As stated before, to activate this function it is necessary to be logged as “user level” or technical level
To login is necessary to access (from Main Screen) to Setup and the to “Log In-out”, then press “LOGIN” and
type 1010 as password (user level password) or 1990 as technical password, then press the “LEFT ARROW”
and then “Back”. On the MAIN MENU will be indicated the “LOGIN: user level”. Now is possible to access
“Availability” (from Main Screen) and then pressing “Warning level” the instrument will display the current
warning level and also the SET button.
Pressing SET the instrument allow to modify threshold level using the keyboard.
To increase availability type the desired warning value, then press the “Left Arrow” to confirm. The instrument
will display the previous image with the new warning reference; pressing “Back” it is possible to go back to MAIN
SCREEN.
9.3.2 – DISPLAY AVAILABILITY
To access this function it is NOT necessary a password
Pressing “Display Availability” the instrument will printout and display the current availability,
pressing “Back” it is possible to go back to MAIN SCREEN.
9.4 – COMM MENU (Technical password required)
Under this menu resides all the functions and options related with the communication between Roller 10 and a
Host Computer. To modify the whole parameters’ values is MANDATORY to login using the Technical
Service password (see chapter 9.2.7).
Without a password
message
As stated before, to activate this function it is necessary to be logged as “tech level” otherwise the instrument
will not allow to access the function.
pressing “LOGIN” the instrument will display a keyboard to type the password, type the password:1990 then
Now on MAIN MENU will be indicated the “LOGIN: tech level”. Then pressing “Setup” from Comm menu, the
instrument shows the following options
9.4.1 – SETUP MENU
After have pressed “Setup” the instrument will display:
9.4.1.1 – INSTRUMENT NUMBER
This option is useful to connect more instruments to the same PC Lab is for assigning a number to every
instrument between 01 to 99.
This number will be also reported in the Q and R strings of Query protocol.
Pressing “Str. n.” the instrument will display a keyboard, type the desired instrument number (for example
number 08), then press the “Left Arrow” to confirm or “Clear” to exit without change anything. The instrument will
display the previous image with the new instrument number displayed inside the corresponding button.
9.4.1.2 – TIMEOUT
This function (used only during the ESR result transmission to host) allows to increase the waiting time to get an
answer from Host computer. This option is useful if the instrument is connected to a network where the Host
computer (due to its working load) needs more than 2 seconds to answer a query.
The default value is 2 seconds, and the possible choice is between 0 to 60 seconds.
This function works if “ACK” flag has been activated, if not, timeout is 2 seconds which is the default
value.
Pressing “Timeout.” the instrument will display a keyboard, type the desired timeout waiting time (for example 05
seconds), then press the “Left Arrow” to confirm or “Clear” to exit without change anything. The instrument will
display the previous image with the new timeout number displayed inside the corresponding button;
9.4.1.3 – ATTEMPTS
This function allows to set the number of attempts (of timeout events) for:
• Query Host computer (Q message)

• Wait an answer from Host computer (T message)
• Refertation (wait an ACK from Host computer) after have sent the results (R message)
This function works according to the status of “Do on T. out” and “ACK” flags
• Q message: after “n” attempts (without getting an ACK from Host computer) the instrument will allow to load
the sample if “Do on T.out” flag is set to “Yes”, otherwise will deny the sample load.
• T message: after “n” attempts (without getting a T message from Host computer) the instrument will allow to
load the sample if “Do on T.out” flag is set to “Yes”, otherwise will deny the sample load
• R message: after “n” attempts (without getting a ACK that confirms the reception from Host computer) the
instrument will skip the transmission of that sample result, will only printout the result and will
proceed to analyze the next sample if “Do on T.out” flag is set to “Yes”, otherwise will deny the
sample load.
Pressing “Attempts.” the instrument will display a

keyboard, type the desired attempts, the possible choice
is between 0 and 99, (for example 10 attempts), then
press the “Left Arrow” to confirm or “Clear” to exit
without change anything.
The instrument will display the previous image with the
new attempts number displayed inside the corresponding
button;
Pressing “Back” it is possible to go back to MAIN SCREEN.
9.4.1.4 – MISSING ID
This function, if activated, allow analysis of samples that:
• Host doesn’t recognize (instrument receives a

NAK answer after a query)
• After the attempts trials has expired and the ID
number inside Q message do not match the ID
number inside T message
To access the function press “Missing ID” then, to

activate the function press “YES”, or to deactivate the
function, press “NO”; after that, pressing “Back” the
instrument will display again the Setup Menu screen.
9.4.1.5 – DO ON TIMEOUT UART
This function, if activated, allow analysis of samples if:
• The waiting time set on “Timeout” menu

(9.4.1.2.) has expired and Host computer hadn’t
send back a T message or a NAK message
during the timeout time.
To access the function press “Do on T.out” then, to

9.4.1.6 – ACK
This function is directly related with “Timeout Uart” (9.4.1.2); if activated allows the TIMEOUT UART function to
extend the delay time for wait a “T” message (Query answer from the HOST computer) and ACK (acknowledge
message from HOST computer).
To access the function press “ACK” then, to activate the function press “YES”, or to deactivate the function, press
“NO”; after that, pressing “Back” the instrument will display again the Setup Menu screen.
9.4.1.7 – BAYER (only with BCI interface)
The function is used in “R” message to grant the Bayer protocol compatibility. This option is used if Host
computer handles Bayer DAT protocols.
• If Bayer is enabled (default), the instrument uses

the Bayer DAT protocol directives.
• If Bayer is disabled, the instrument uses the
modified DAT protocol
Bayer communication protocol detects the Bayer field

value (the field before the ESR result) in the “R”
message. If Bayer function is enabled, the field will
contain '01' (hex 30 and 31) to maintain the Bayer
protocol compatibility otherwise if it is disabled, the field
will report the number of Cycle.
To access the function press “Bayer” then, to activate the function press “YES”, or to deactivate the function,
press “NO”; after that, pressing “Back” the instrument will display again the Setup Menu screen.
9.4.1.8 – 6 Parameters Transmission (under development).
The function is used to send additional results to host computer. Roller family instruments are able to analyze
blood and in addition to ESR determine also other 5 parameters. Depending how many of this parameters has
been activated (using a specific smart card like one in the photo, in this case only for ESR and Anemia Factor),
the instrument will send results to host computer.
• If “Send 6 par” is disabled (default), the instrument

sends only ESR resul to host computer.
• If “Send 6 par” is enabled, the instrument sends
also the results of the other activated parameters.
To access the function press “Send 6 Par” then, to

Here is an example of parameters transmission from instrument to Host computer (in this example all 6
parameters are activated)
ESR Result
Aggregation Factor
Anemia Factor
Viscosity Factor
Hematocrit Factor
Hemoglobine Factor
NOTE: at the moment it is not suggested to activate 6 parameters transmission to host computer because
Host protocol is not deigned to receive all 6 parameters, only ESR.
9.4.1.9 – PROTOCOL INTERFACE OPTIONS
In the lower part of the Communication Setup configuration screen is possible to choose the protocol to be used to
communicate between the Roller 10 and the Host computer. The instrument offers 4 choices:
PORT2 connection.
The instrument communicates through Serial Port 1.This port

uses a 9 pin male (DB9) serial connector.
The used pins are: n° 2 for TXDATA, n° 3 for RXDATA and 7

for ground. The remaining pins are connected together as null-
modem configuration.
This cable must have a D-type 9 pin female connector from

one side and a D-type 9 pin female connector at the opposite
side.
SERIAL CABLE PIN CONNECTIONS TO CONNECT ROLLER10PN/20PN TO PC-LAB:
DB9 F DB9 F
1 1
2 2
3 3
4 4
5 5
6 6
7 7
8 8
9 9
Interface protocol uses the following parameter:
Speed: 9600
Length: 8 bit
Parity: N
Stop: 1 bit
9.4.1.9.a – DAT 8 INTERFACE (NO QUERY)
Pressing “DAT 8 button, the instrument will highlight and activate this option as communication protocol
PROTOCOL Query DESCRIPTION R message structure SYMBOLS NOTES

Used to read the ☻ Checksum note
maximum patient STX 1 byte Checksum value is the result of
identity length of R 1 byte Exclusive OR (XOR) of all
8 characters by Not used 2 byte characters of the message,
an external bar Identification no 8 byte excluded STX, ETX and
Checksum. If the Checksum value
code reader Not used 6 byte ♥
calculated by the analyzer is 03
(EBCR) It can be ESR result 4 byte (corresponding to ETX), or 02
DAT8 also used to Checksum 1 byte (corresponding to STX), or 00
No insert patient IDs ETX 1 byte (corresponding to NULL), the
manually. value will be automatically
TOTAL = 24 byte replaced with 7F hex value.
Software House must adopt the
same procedure when
calculating checksum of the
strings received from the
analyzer.
DAT8 transmission and its examination:
Hex Length Note1:

Field name Symbol Description
value Checksum value is the result of
Exclusive OR (XOR) of all
STX ☻ 02 1 char Start transmission characters of the message,
‘R’ 52 1 char R states for result message excluded STX, ETX and
Workstation Is the number identifying the instrument if more Checksum. If the Checksum value
2 char
Number than one is connected to Host computer calculated by the analyzer is 03
Patient ID (corresponding to ETX), or 02
8 char Patient identification
Number (corresponding to STX), or 00
Wheel no. 2 char Indicate the progressive number of analysis made (corresponding to NULL), the
Position 2 char Indicate the sample position inside the wheel value will be automatically
Bayer replaced with 7F hex value.
2 char See note 2 Software House must adopt the
(Note 2)
Result 4 char ESR result same procedure when
Checksum calculating checksum of the
1 char See note 1
(Note 1) strings received from the
analyzer.
ETX ♥ 03 1 char End transmission
Note2: Bayer field not used, in this
case show s the progressive
analysis cycle
Total length 24 char
9.4.1.9.b – DAT 15 INTERFACE (NO QUERY)
Pressing “DAT 15” button, the instrument will highlight and activate this option as communication protocol

Note1:
Checksum value is the result of
characters of the message,
excluded STX, ETX and
Checksum. If the Checksum value
STX 1 byte ☻ calculated by the analyzer is 03
R 1 byte (corresponding to ETX), or 02
Used to read (corresponding to STX), or 00
Workstation number 2 byte
the maximum (corresponding to NULL), the
Identification n 15 byte value will be automatically
patient identity
Rack number 2 byte replaced with 7F hex value.
DAT15 length of 15
No Position 2 byte Software House must adopt the
characters by same procedure when
Cycle/Bayer 2 byte
an external bar calculating checksum of the
ESR result 4 byte
code reader strings received from the
Checksum 1 byte analyzer.
(EBCR). ♥
ETX 1 byte
TOTAL = 31 byte Note2: If Bayer is NO, the field deals
with the number of Cycle
otherwise if Bayer is YES, the field
will contain '01' (hex 30 and 31) to
maintain the Bayer protocol
compatibility.
DAT15 transmission and its examination:

Hex Length Note1:
2 char
Rack no. 2 char Indicate the progressive number of analysis made (corresponding to NULL), the
(Note 2)
1 char See note 1
analyzer.
Note2:see previous table
9.4.1.9.c – BCI INTERFACE (QUERY)
Pressing “BCI” button, the instrument will highlight and activate this option as communication protocol

Note1:
Used to read Checksum value is the result of
the maximum Exclusive OR (XOR) of all
patient identity characters of the message,
excluded STX, ETX and
length of 15 ☻ Checksum. If the Checksum value
characters by STX 1 byte
calculated by the analyzer is 03
an external bar R 1 byte (corresponding to ETX), or 02
code reader Workstation number 2 byte (corresponding to STX), or 00
(EBCR). The Identification n 15 byte (corresponding to NULL), the
Rack number 2 byte value will be automatically
instrument replaced with 7F hex value.
BCI Yes Position 2 byte
enables Query Software House must adopt the
Cycle/Bayer 2 byte same procedure when
protocol to
ESR result 4 byte calculating checksum of the
interrogate the strings received from the
Checksum 1 byte
host if a ETX 1 byte ♥ analyzer.
specific TOTAL = 31 byte Note2: If Bayer is 0, the field deals
sample needs
with the number of Cycle
to be analyzed otherwise if Bayer is 1, the field
or not. will contain '01' (hex 30 and 31) to
maintain the Bayer protocol
compatibility.
BCI transmission and its examination:

Hex Length Note1:
2 char
Rack no. 2 char Indicate the progressive number of analysis made (corresponding to NULL), the
(Note 2)
1 char See note 1
analyzer.
Note2:see previous table
The main difference between DAT15 and BCI is than in BCI mode the instrument works with the Query Host
Protocol, the “R” has the same composition as in DAT15
9.4.1.9.d – No HOST
Pressing “NO Host” button, the instrument works alone, it is not connected with a Host Computer and no kind of
communication is enabled.
9.4.1.10 – PROTOCOL INTERFACE EXPLICATION
This chapter describes the serial protocol (Query Protocol) used by Roller 10 with an External Bar Code Reader
(EBCR) connected to Serial Port 2 (RS232C).
This protocol is the same used by QUERY TEST1 program; a Windows software designed to be loaded in a
Personal Computer (LAB PC) installed in a laboratory and connected to HOST through a network.
QUERY protocol uses two files to exchange data for the communication with HOST by using the LAB PC like a
bridge between Roller 10 and HOST Computer.
Messages used.
‘Q’ message from Roller 10 ‘T’ message from HOST ‘R’ message from Roller 10
Hex Hex Hex Length

Field name Length Field name Length Field name
value value value
STX (Note 2) 02 1 char STX (Note 2) 02 1 char STX (Note 2) 02 1 char
‘Q’ 51 1 char ‘T’ 54 1 char ‘R’ 52 1 char
Workstation Workstation Workstation
2 char 2 char 2 char
number Number Number
Patient ID Patient ID Patient ID
15 char 15 char 15 char
number Number Number
Result 4 char Result 4 char Rack no. 2 char
Checksum (Note 1) 1 char Checksum (Note 1) 1 char Position 2 char
ETX (Note 2) 03 1 char ETX (Note 2) 03 1 char Cycle/Bayer (Note 5) 2 char
Result 4 char
25
Total length 25 char Total length Checksum (Note 1) 1 char
char
ETX (Note 2) 03 1 char
Protocol explanation:
1. The patient bar code ID stuck on each sample tube can be

read by using of an External Bar Code Reader connected at <STX>Q01123456789 0000a<ETX>
the Roller 10 Serial Port1. The instrument will create and send
“Q” message to the HOST computer through RS232 serial port (or to LAB PC if used like a bridge) if
Query Setup option is 1. (Note 3)
2. HOST computer verify if the patient identity has been inserted in the working list and then it replies with
"T" message. Meantime Roller 10 remains waiting up to 2 seconds for receiving it if ACK option (9.4.1.6)
is NO. It will wait for all the set time (TIMEOUT 9.4.1.2) if ACK option is YES. (Note 4)
As soon as the instrument receives “T” message, it will be <STX>T01123456789 0001e<ETX>
checked.
The wheel will rotate to one position to allow the operator to
insert the sample tube, if “T” message has the result field <STX>T01123456789 0000d<ETX>
compiled with “0001” (that means the sample requires the
analysis). The wheel remains stop, if the result field will be “0000” (the analysis of that particular sample is
not requested).
The procedure explained above starting from 1 to 2 will be repeated for further sample tubes up to
th th
the 10 (Roller 10) or the 20 (Roller 20) before starting the analysis.
3. After measuring (20 seconds about), Roller 10

<STX>R01123456789 0103050012f <ETX>
compile “R” messages replacing the result field value
(0001) with an ESR value that, read on the paper
could be between values of 0002 and 0120 or a <STX>R01123456789 010305-004l <ETX>
negative one. For reading errors, the instrument will
report the error codes like: --001 for SM error, -002 for NR error and -004 for NF error.
4. Host computer should send an ACK confirmation byte ( ♠ symbol looking at Hexadecimal code 0x06
the hyper terminal program) to Roller 10 for having accepted “R” message.
The instrument will ignore it, if ACK option is NO. It will wait for all the set time (TIMEOUT from 2 to 60
seconds) if ACK option is YES.
Warnings:
1. If the patient identity (ID) read by the Scanner doesn’t find its own correspondent in the Host computer
working list, “T” message will be replaced by <NAK> message (§ symbol Hexadecimal code 0x21
looking at the hyper terminal program), the wheel will however rotate to the
next position to allow the operator to insert the tube if the MISS ID option is
set to YES and the sample will be analysed and “R” message sent to host, otherwise the wheel will not
rotate.
2. If no label has been stuck on the tube or the external Scanner cannot read the patient ID, “Q” message
won’t be created. The wheel will rotate to accept the sample by pressing “Next” button on display and then
inserting the tube in the corresponding rotor position.
The sample will be however processed and “R” message sent to host with an identity code generated by
itself. The new patient ID in this case will be composed by 10 characters:
Cycle number (2 characters from 01 to 99), instrument s/n (4 characters), wheel number ( 2 characters)
sample position in the wheel (from 01 to 10- 2 characters).
Example:
Instrument s/n Wheel number
0307920106
Cycle number Sample position in the wheel
A complete “R” string for the transmission will be:
[Workstation number] [Instrument s/n] [Wheel number] [ESR] [Checksum]
<STX>R010307920106 0106030012f
[Cycle number] [Sample position] [Cycle number (Note 5)]
Note 1: Checksum value is the result of Exclusive OR (XOR) of all characters of the message, excluded STX, ETX and
Checksum. If the Checksum value is 03 (corresponding to ETX), or 02 (corresponding to STX), or 00
(corresponding to NULL), the value will be replaced with 7F hex value. The same thing must be done by the
software house.
Note 2: <STX> character (☻symbol looking at the hyper terminal program) in the serial transmission is represented by
0x02 hexadecimal bytes and <ETX> ( ♥ symbol looking at the hyper terminal program) by 0x03.
Note 3: If Query Setup option is 0, no Query protocol will be created; the instrument will accept and analyse all samples.
Note 4: Follow the instruction looking at the Chapter 9.4.1.2 of the technical manual for TIMEOUT UART activation.
Note 5: This field is related to Bayer parameter on SETUP. If Bayer is 0, the field contains the number of Cycle. If Bayer
is 1, the field contains '01' (hex 30 and 31) to keep compatibility with Bayer protocol.
9.4.1.11 – LATEX PROTOCOL INTERFACE EXPLICATION
When the instrument runs latex controls, it is possible to send the results to host computer, in this case the instrument will
send a specific string here explained:
‘R’ message for Latex

Hex Length
Field name Description
value
STX (Note 2) 02 1 char
‘R’ 52 1 char Means the instrument is sending a Result
Identifies the workstation if more instrument are
Workstation Number 2 char
connected, normally is 01
Is the identification of the latex and the Lot
LATEX0 XYZ 9 char
to which they belong
Can be 1, 2 or 3 and identifies level 1, 2 and 3 of
Field 1 1 char
latex
ESR Value 3 char This is the expected Latex ESR value
Space. 20 2 char Two spaces
Field 2 2 char Fixed to 01
Field 3 2 char The same as Field 1
Field 4 2 char The same as Field 2
ESR Value 4 char This is the detected Latex ESR value
Checksum (Note 1) 1 char
ETX 03 1 char
Note 1: Checksum value is the result of Exclusive OR (XOR) of all characters of the message, excluded STX, ETX and
Checksum. If the Checksum value is 03 (corresponding to ETX), or 02 (corresponding to STX), or 00 (corresponding
to NULL), the value will be replaced with 7F hex value.
Software House must adopt the same procedure when calculating checksum of the strings received from the
analyzer.
here are some examples:
<0x2>R01LATEX08451005 0101010002<0x19><0x3>
<0x2>R01LATEX08452036 0102010034<0x1c><0x3>
<0x2>R01LATEX08453083 0103010071<0x13><0x3>
9.4.1 – TEST MENU
After have pressed “Test” the instrument will allow to check the communication between the instrument and
PC-LAB :
And the following results can be displayed on the Pc-Lab monior:
If DAT8 is chosen, the test message having 8 ID digits will be sent to the Host like:
<0x2>R01TESTR10A0001010002U<0x3>
<0x2>R01TESTR10B0001020015S<0x3>
<0x2>R01TESTR10C0001030031U<0x3>
<0x2>R01TESTR10D0001040090^<0x3>
<0x2>R01TESTR10E0001050100V<0x3>
<0x2>R01TESTR10F0001060120T<0x3>
<0x2>R01TESTR10G000107-004N<0x3>
<0x2>R01TESTR10H000108-004N<0x3>
<0x2>R01TESTR10I000109-002H<0x3>
<0x2>R01TESTR10J000110-001@<0x3>
Selecting DAT15 or BCI, the ID digit number to send to the Host is going to be 15 like:
<0x2>R01TESTR10A 0101010002t<0x3>
<0x2>R01TESTR10B 0102010015r<0x3>
<0x2>R01TESTR10C 0103010031t<0x3>
<0x2>R01TESTR10D 0104010090<0x7f><0x3>
<0x2>R01TESTR10E 0105010100w<0x3>
<0x2>R01TESTR10F 0106010120u<0x3>
<0x2>R01TESTR10G 010701-004o<0x3>
<0x2>R01TESTR10H 010801-004o<0x3>
<0x2>R01TESTR10I 010901-002i<0x3>
<0x2>R01TESTR10J 011001-001a<0x3>
If NO HOST is configured, the instrument will not communicate with Host Computer
9.5 – TECH MENU (Technical password required)
Under this menu resides all the functions and options related with the TECHNICAL CONFIGURATION of Roller
10. To modify the whole parameters’ values is MANDATORY to login using the Technical Service password.
NOTE: in this chapter are explained all the technical functions available on the Roller family
instruments, this mean that the explanation will include all configurations (from R10 up to R20 PN).
Furthermore, for each function will be explained which options are available on each instrument
configuration.
Without a password
message
As stated before, to activate this function it is necessary to be logged as “tech level” otherwise the instrument
will not allow to access the function. The tech level password requires the Technical Service Personnel
intervention in fact this kind of password must be requested to the Factory Technical Service Dept.
Now on MAIN MENU will be indicated the “LOGIN: tech level”. Then pressing “Tech” from main menu, the
9.5.1 – PUMP CONFIGURATION (NORMAL and PN MODELS)
This function, if activated, allow to setup the amount of blood to be withdrew from the sample tube:
• Automatic taking:
This option is available on all models; pressing
“SET” will be displayed a digital keyboard where
is possible to set the desired amount of blood to
be withdrew. The amount is expressed in
microliters. The corresponding quantity of steps
made by the peristaltic pump is displayed as
reference.
To set the desired amount of blood, type the “number”

(remember it is expressed in microliters) then press
the “left arrow” to confirm or “Clear” to exit without
change anything, in both cases, the instrument will
display again the previous image.
After have set up a value, the corresponding amount
of step is also displayed.
Pressing “for” or “rev” is possible (having previously inserted a tube and moved up the syringe inside the sample
tube) simulate the withdraw (aspiring or discharging).
If after the simulation, the amount withdrawn is not enough (or so much) it is possible to adjust the quantity setting
a new value repeating the previously explained procedure.
• Manual taking:
This option is available only on PN models;
pressing “SET” will be displayed a digital
keyboard where is possible to set the desired
amount of blood to be withdrew. The amount is
expressed in microliters. The corresponding
quantity of steps made by the peristaltic pump is
displayed as reference.
To set the desired amount of blood, type the “number” (remember it is expressed in microliters) then press the
“left arrow” to confirm or “Clear” to exit without change anything, in both cases, the instrument will display again
the previous image.
After have set up a value, the corresponding amount

Pressing “for” or “rev” is possible (having previously

activated the manual syringe and being ready to insert
a sample tube when requested) simulate the
withdowal even aspiring or discharging.
If after the simulation, the amount withdrowed is not enough (or so much) it is possible to adjust the quantity
setting a new value repeating the previously explained procedure.
• Fast:
“FAST” peristaltic pump is activated and still on
until “FAST” is pressed again. This function is
useful to check if the pump works correctly.
Depending the status, on the right side of the
button will be displayed ON or OFF.
• Retention:
“RETENTION” peristaltic pump is engaged in a stand still status (in this status pump’s internal coils are
powered in a manner the rotor is stopped but it is impossible to move it manually). Pressing again
“RETENTION” the pump is released. This function is useful to check if the pump works correctly.
Depending the status, on the right side of the button will be displayed ON or OFF.
• Reset persistaltic:
This option is available on all models; pressing “RESET PERISTALTIC” the peristaltic pump is reseted
and will be automatically set in a position where both rolls presses the capillary tube. In this way is also
possible to check if the HOME sensor works or not.
This function stops automatically.
• Wash pump:
This option is available ONLY ON Rollor 20 PN; pressing “WASH PUMP”, washing pump is activated
and still on until “WASH PUMP” is pressed again.
Washing pump is used to wash the capillary circuitry. Water is aspired from the wash tank, sent
throughout the capillary and the needle and is discharged in the waste tank.
This function is useful to check if the pump works correctly.
Depending the status, on the right side of the button will be displayed ON or OFF.
Pressing “Back” the instrument will display again the Main Menu screen.
9.5.2 – SYRINGE AUTO
This function, if activated, allow to setup the excursion of the needle inside the sample tube:
• Up and Down:
is possible to set the desired excursion of the
needle inside the sample tube. The excursion is
expressed in steps.
To set the desired excursion, type the “number”

(remember it is expressed in steps) then press the
“left arrow” to confirm or “Clear” to exit without
After have set up a value, the corresponding excursion
Now pressing “Up” the needle will go up, pierce tube’s cap and goes inside the tube until reach the excursion set
previously. On the contrary, pressing “Down” (considering the needle is inside the tube) the needle cames out
from the tube and the piston goes down to home position. If the needle is already in home position, pressing
“Down” will not have any effect.
“Steps” option allow to move up the needle step by step (each step excursion equal xxxx steps). The move down
the needle press “Down”
• Up in Wash:
This option is available ONLY ON Roller 20 PN
models; pressing “SET” will be displayed a
digital keyboard where is possible to set the
desired excursion of the needle inside washing
manhole. The excursion is expressed in steps.

Now pressing “Up in wash” the needle will move to the left toward the washing manhole, will up inside and the
instrument washes the needle externally and internally activating also the peristaltic pump to wash the needle
inside.
Pressing “Down” (considering the needle is inside the tube) the needle comes out from the manhole and the
piston goes down to home position.
9.5.3 – SYRINGE MAN (AVAILABLE ONLY ON PN MODELS)
This function, if activated, is used to setup the excursion (outside the plastic cover) of the external needle in order
to allow the instrument analyze paediatric sample or sample tubes with plastic cap.
• Out limit:
Pressing “SET” will be displayed a digital
keyboard where is possible to set the desired
excursion of the external needle outside the
plastic cover of the instrument. The excursion is
expressed in steps.

Now pressing “Out limit” the needle will go outside the plastic cover of the instrument up to reach the steps set
previously. If during the displacement the needle passes the “out of limit sensor” the instrument MUST stop
needle’s run.
Pressing “Home” (considering the needle is outside) the needle comes back to its home position. In this way is
possible to check home sensor operativity. out from the tube and the piston goes down to home position. If the
needle is already in home position, pressing “Down” will not have any effect.
“Taking steps” option allows to move up the needle step by step.
To move up the needle press “Home”
9.5.4 – CARRIAGE ALIGNMENT (AVAILABLE ONLY ON ROLLER 20 PN INSTRUMENTS)
This function, if activated, is used to check and setup carriage movements on instrument with 2 rotors. Needle left
and right displacement must be aligned with the vertical axis of the corresponding left and right rotor. Furthermore,
to be perfectly aligned is also necessary to verify the needle goes inside the left and right tubes without
impediments.
Once selected this function, the instrument will display the following options:
Rotor 2:
This option moves carriage under the “right rotor”.
Rotor 1:
This option moves carriage under the “left rotor”.
Home:
This option moves carriage under the washing
lodgement that is considered also as “Home Position”.
Step Sx:
Pressing this button moves carriage 1 step Left.
Step Dx:
Pressing this button moves carriage 1 step Right.
Save:
Once verified the alignment below every position is good, pressing this button, instrument memorizes the
coordinates that will be used every time carriage moves below corresponding position.
Note: “save” function is not cumulative, must be done for each individual position; once saved the coordinate,
press the button corresponding the next position (it is suggested follow this path: Home, Rotor 1 Rotor 2) and
align carriage by pressing Step Sx or Step Dx, then press “Setup Syringe” to move close the piston to the
home or rotor position in order to check if they “match” together. To move down the syringe, press “Down”.
Reset All
Pressing this option, all memorized coordinates are erased and it is necessary to repeat the alignment of each
individual position, saving again once reached a good alignment between the tube and piston’s tip. The same
must be done for the home/washing position zone.
For the lateral alignment please refer to chapter 13.8 c
9.5.5 – ROTOR
This function, if activated, is used to verify rotor’s alignment (first it is necessary to remove the plastic cover) with
the sample’s tube vertical line taking as reference the “X” axe.
Reset:
Pressing “Reset” the rotor is moved to home
position (that correspond with position 1 in front of
the loading door).
Next pos.:
Pressing “Next Pos.” the rotor is moved one
position ahead, this is useful to verify if the
stepper motor works fine, because each
interdisplacement is made by steps.
Retention.:
Pressing “Retention” rotor’s stepper motor is
configured to keep its coils energized thus
allowing rotor to stay stable and stopped in the
position in which is left. Pressing again
“Retention” stepper motor is released.
Take vial in position.:

Pressing “Take vial in position” allow rotor to be moved just above the piston. Stopping position belong to
the corresponding sample tube selected.
To select which tube must be placed above the
syringe, just type the “number” then press the
change anything, in both cases, the instrument
will display again the previous image and move
the rotor to the corresponding position
Pressing “Clear” the instrument will display again the

Main Menu screen.
9.5.6 – SENSORS
This function, if activated, is used to check if the sensors spread inside the instrument works.
Sensor in grey means that it is activated (magnet

in front of the sensor)
Sensor in blue means that it is not activated
(magnet not in front of the sensor)
NOTE: what above is NOT valid for the

following sensors: Vial UP and Vial Down.
In this case the meaning is exactly opposite:
grey sensor means no tube in front of the
sensor and blue sensor means tube in front of
the sensor.
Vial up and down sensors are used to detect the presence of tube inside the rotor, so when a tube is detected
by the sensor, means the tube has been inserted all the way down the lodgement and the status of both sensors
is as displayed on the above picture.
9.5.6. a – ROTOR ADJUSTMENT FOR SARSTEDT TUBES
If Sarstedt tubes are used, it is necessary to adjust rotor’s position in order to allow “vial down” sensor detect the
presence of tube.
The problem of Sarsted tubes is that the cap ifs very narrow and c an easily exit from the sensor reading path.
GOOD WRONG
GOOD
This photos shows a comparison between a not well aligned tube but in any case inside sensor’s path (left), a
wrong aligned Sarstedt tube outside sensor’s path (right) and a well aligned Sarstedt tube inside sensor’s path.
In order to align rotor and allow tube sensors detect presence of Sarstedt tubes follow the procedure described in
the next page.
Login as “technical level” (with full access to the functions); to login is necessary to access Setup and “Log
In-out”, then press “LOGIN” and type the appropriate password (1990 for technical level).
Open the door and insert a SARSTEDT tube

into the wheel first position.
Then select “Sensors” from the Tech menu

and once the Sensors screen is displayed,
press twice “Tube Offset”.
Instrument will display a Keyboard:

• Type a value between -127 to + 127
• Press on [+/-] key for a negative value; (if
pressed by mistake, press again on [+/-]
to get a positive value).
• Then press the arrow
Rotor will rotate and tube in position 1 will stop in

the new position; now check if “Vial down sensor”
change form blue to grey, in this case tube has
been detected by sensor meaning the adjustment
went fine.
Otherwise repeat that procedure until SARSTEDT tube cap will be centred between the sensor path
On the screen it is also reported the current offset (in this case 0). Offset is also reported on flag list as displayed
in the next picture:
9.5.7 – ROTATING VALVE (AVAILABLE ONLY ON ROLLER 10 PN and ROLLER 20 PN INSTRUMENTS)
This function, if activated, is used to check and setup the electro valves used to drive blood from the windrow
needle (internal or external) to the reading unit.
This valves are also used to drive water from internal or external needle to the reading unit during the washing
procedures..
Pressing “Internal Circuit” is possible to rotate if the valve in

order to withdraw blood/water flow from internal needle to the
reading unit works.
Pressing “External Circuit” is possible to rotate if the valve

in order to withdraw blood/water flow from internal needle to
the reading unit works.
10.0 – FIRST INITIALIZATION AND STARTUP
The instrument is already calibrated in factory, this means it is ready to be installed and used.
Basically, First-Up procedure read a sample of water and automatically adjust the DAC levels (quantity of light
emitted by the 3 LED inside the reading unit) in other to obtain a corresponding values of ADC around 3800.
Normally this procedure is done in factory and should not be executed anymore neither in case of capillary
replacement.
First-Up procedure can eventually be done in case the instrument still report PHOTOMETER NOK, in this case
during the First-Up, DAC are re-set to a value which should correspond to an ADC of around 3800.
To do this login as Technical User
pressing “LOGIN” the instrument will display a keyboard to type the password, type the password: 1990 then
Then access CPS Menu pressing “Setup” from the MAIN SCREEN, the instrument shows the following options
then pressing “First Up” the instrument will ask to load a tube filled ¾ with distillate water into position 1 of the
rotor.
Close the loading door. The instrument will set itself and at the end will ask to remove the sample tube and will
display “First Up OK” if the “White Calibration” went fine.
Now it is necessary to recalibrate again the instrument using a Latex Calibration Kit.
To calibrate is necessary to go back to the Main Screen, choose Standard from Main Menu
If latex Calibrators are loaded, instrument will require to login as Technical User otherwise it will not
allow to continue with the calibration process.
The instrument will ask to insert latex following this sequence:
• 1 tube filled ¾ with distillated water

• 1 tube “tube 2” of Latex control previous identification by EBCR or typing manually the number printed
below the bar code
below the bar code
below the bar code
• 2 tubes filled ¾ with distillated water
The instrument will check:

• If the Latex expired date has been passed, in this case it will withdraw the content of the 3 latex tubes
without performing the control or calibration
• if the three tubes belongs to the same kit, if not will tell the inserted codes are inconsistent, in that case
press “Clear” and the instrument will ask to remove the tubes.
• if more than 5 weeks has passed after the first piercing date of the inserted triplet, in this case it will
withdraw the content of the 3 latex tubes without performing the control or calibration
• if the loaded triplet has been used more than 6 times, in this case it will withdraw the content of the 3 latex
tubes without performing the control or calibration
If all checks are ok, it will begin the control procedure.
At the end, if everything went ok, the instrument will printout the control/calibration results in the following
sequence:
1. Reference levels (the same printed on the label stuck on the latex control/calibrator box)
2. Read level, will display the three latex levers read by each one of the two sensor
3. Now the instrument (If the latex are Calibrators) asks to set (just press “SET” option on the
screen) the new reference levels
4. The instrument will display again the reference values (the same printed on the label stuck on the latex
control/calibrator box) and new values got by the CPS unit after the calibration.
5. All the previous information is also printed out.
6. Press back.
7. The instrument will ask to remove, one by one, the tubes used during calibration/control.
This image shows a printed report after a Calibration, as is possible see it is divided in 4 main parts:
Part 1:
Washing sequence, were the instrument make a wash of the hydraulic circuit to
remove all possible residual blood particles and then reads “water reference”
Part 2:
Latex Calibration / Control labels read by External Bar Code Reader or inserted
typing manually
Part 3:
In this part the instrument printout the previous settings (only during Calibration)
Part 4:
In this part the instrument printout the result get after the Calibration / Control
procedure
Latex calibrators/controls are tested and measured using a STANDARD PHOTOMETER, this means that using
calibration latex, the values obtained (MFact1 and MFact2) guaranties that an instrument is perfectly aligned
with all the other instruments around the world because all the latex controls are referred to a STANDARD
PHOTOMETER measure.
In other words, a blood sample analyzed in one instrument will have the same result in another instrument
located in any other lab around the world if that instrument was also calibrated using latex.
1. Suggested option
Work with the latex reference (MFact) BoosterY MUST be set to 1.000. In this way the instrument is
perfectly aligned and works in standard mode, that means all the ESR values will be calculated using the
value obtained by latex calibration which is aligned with the STANDARD PHOTOMETER measure.
2. Work without latex reference, in this case the MFact’s obtained with calibration are still used as a method
to keep under control the instrument, BUT the BoosterY value IS NOT SET to 1.000, in fact, the
laboratory will increase or decrease manually the reference value and will setup the BoosterY based on
its historical data. In this case the equipment will work OUT OF STANDARD because it is aligned to the
laboratory’s historic data and not aligned to the STANDARD PHOTOMETER measure.
Even if the second option is chosen, each time the instrument run the Latex Controls, the reading unit is in any
case kept under control even considering the instrument works OUT OF STANDARD. In any case consider
that the Latex Control procedure runs considering the MFact value as its reference.
When the instrument is calibrated using latex calibrators and BoosterY has been set to 1.000 (option 1), could
be that the new ESR values (compared with the ESR values obtained before the calibration) will be constantly:
higher or lower
• HIGHER means the instrument overestimates the ESR (compared with previous laboratory’s historical data)
• LOWER means the instrument underestimates the ESR (compared with previous laboratory’s historical data)
But in both cases the instrument works fine (according to the calibration values obtained by latex because the
instrument is perfectly aligned with the STANDARD PHOTOMETER measure).
The three ESR resulting values should fit the ranges reported both on the print itself (“Reference values”) and on
the outer label in the table “REFERENCE VALUES”.
In case the obtained values after control keep staying outside the expected ranges it will be necessary to check
the instrument hardware. In this case please call the Technical Service to check the instrument performances.
To calculate the new BoosterY’s value please refer to chapter 9.1.3.a
If necessary to modify BoosterY’s value proceed as follows:
Access again CPS menu
then pressing “Parameters” will be displayed CPS’s

parameter allowing to modify BoosterY’s value pressing
SET.
Pressing “SET” the instrument allow to modify BoosterY’s value according to local Lab’s references or
Westergren references. To modify just type the desired value
again the previous image with the BoosterY’s new value. Pressing “Back” is possible to go back to MAIN
SCREEN.
Now access again Setup (from Main Screen)
Press “Log In - Out” (in the Setup Menu), the instrument will display:
Press “Logout” to exit from the Technical User level and to allow operator to begin to work with the instrument.
11.0 – SOFTWARE UPGRADE
This instrument uses 5 different processors that are mounted on 5 different specific boards. To upgrade all the 5
boards software it is not required to replace EPROMs (like in Test 1). This new system is upgraded using a
serial cable connected to a PC.
Here follows the procedure required to upgrade the software.
This procedure must be executed only 1 time to install the “Bootloader” program on the PC. (It is
suggested a Laptop).
Load the CD supplied with the instrument, access inside “Roller10 Programmer” directory
1. Install dotnetfx.exe
2. Install langpack.exe
3. Run setup.exe
This installation will create a directory inside c:\programs. This new directory is named AXT\R10 BL MFC and
also creates a shortcut on desktop named “R10 BL MFC”.
If the laptop has no built-in serial port, it is necessary to use an USB to Serial converter, in this case, plug in the
converter in the first available USB port and install (if required) the appropriate driver. Inside the CD is available
the USB to SERIAL driver for the converter available on the supplied kit.
Every software upgrade will be sent directly by email, so after have received it, it is necessary to download and
copy inside c:\programs\AXT\R10 BL MFC.
Every new software release will have a name like this: “R10R10-01.00X.R10” where 00X indicates the release
of software. (X value is a letter from A to Z)
To upgrade physically the instrument proceed as follows:
Switch off Roller10
Plug the serial cable in Roller10 serial port (if necessary unplug the host computer cable)
Execute R10 BL MFC.
This window will be displayed on laptop’s screen
1. Select the serial port of the laptop where you have plugged in the serial cable. If a USB to Serial
converter is used, verify under control panel / system / hardware / Com and LPT, locate the USB/Serial
converter identified as “Prolific USB-to-Serial Comm Port (COM xx)” where “xx” represent the
communication port, in this case the assigned port is port 8. This procedure can also be used if more
than one serial port is available and it is necessary to identify its port number.
2. Select the appropriate software

version changing the “letter” that
indicates software’s release
8
3. Open the serial port
4. Switch on Roller10, the instrument

begin the upgrade process and
“Please wait while downloading
software” is displayed on Roller10’s
display. The process will last about 8
minutes; after that on the laptop’s
screen will appear a message telling
the upload has been successfully
executed.
5. At this point, switch off the instrument,

unplug the serial cable and (if in use)
plug again Host Computer Cable, wait
1 minute and switch again the
instrument; it will configure itself and
will be ready to operate
6. During the upload avoid to run other programs or operate with the laptop.
7. Close the port and the press “annulla” to close the program.
12.0 – NEEDLE REPLACE
The below photos show the quick needle replacing procedure
WARNINGS:
Verify the instrument is switched off
During the needle replacing operations, it is mandatory the use of gloves and protective
glasses, to avoid any contact with potentially infected biological material.
Avoid absolutely to touch the top of the syringe piston, because also a light pressure could
allow the needle to escape and its tip could become extremely dangerous because it could
pierce the glove and the skin. Operate with extreme caution.
REPLACING PROCEDURE
Open the front door pulling up the red lever located on the instrument’s left side of the instrument.
Localize the piston group(displayed in the photo):
Grasp and throw the CBC adapter (piston)
that will tilt to 45°.
Rotate toward right the upper side of the

piston (as shown in the photo.
This procedure allow to access the
piston’s internal side
Insert the red tool (supplied) inside the
piston, unscrew completely the needle
and remove it. This operation has to be
done in safety. Discard the replaced
needle.
Take the new needle, remove the

transparent cap that protects the needle
thread.
The ord. code for the new needle is
SI 195.5077.02.
Insert the tool with the new needle inside
the piston body and tight the needle,
paying attention do not tight excessively to
avoid the thread damage.
Extract the red tool and close the piston’s

cover rotating toward left side.
At this point it’s very important to check the needle comes out from the piston’s tip without any kind of impediments.
To do that the piston must be held using both hands and follow the procedure explained in the next page.
Be careful not to put fingers over the piston’s tip in order to avoid be pierced by the needle’s tip
This operation must be done following
these steps:
1) using right hand press and keep
down the knob located at the
end of the piston
2) if the knob is hard to move
doesn’t or doesn’t move, rotate
a bit to the left and/or to the right
the piston’s body up when the
knob moves inside the piston.
3) Keep the knob inside the piston
to facilitate the piston’s
displacement.
Holding sideways the piston, verify that

moving the piston towards the bottom, the
needle exits from at least 10 millimetres from
the top of the piston.
If there are no impediments, release the
piston, and push toward the internal of the
instrument, till the complete lockage from the
magnets and release the piston.
Once the piston is “locked” and retained by
the magnets Close the door, if necessary
pull up the red lever and push gently the
door to help it sit in the correct position, the
push down the lever to be sure the door is
well hooked.
Note: After needle replacement is suggest to do a washing routine
13.0 – INSIDE ROLLER Family Instruments
Next pages will show all internal components of the instrument. Only Peristaltic pump, Reading Unit, Rotor’s home
sensor and Piston has components that can be replaced by Technical service.
All the 5 boards that are inside the instrument MUST be replaced and not locally repaired.
This plot is intended to represent in a very easy way the internal architecture of the instrument.
Each one of the 5 main boards have its own dedicated processor and all of them are under the control of the Unit
Interface Board that act as a master and handles all the functions of the instrument.
Analogical
Board Communication
(Reading Unit) Board
Unit Interface
Board Peristaltic
Pump
Rotor
Motor
Display and Motor Board
Touch screen
Printer Smart Syringe
Card Motor
Rotor, Pump
and Peripherals
sensor Hub
Board
UI Board and
Display
Syringe and
Carriage Hub
Piston Assembly Board
13.1 – UI Board and Syringe Group
Unit Interface (UI) board has two main functions: drive touch screen display and coordinate the other 4 boards.
It receives “inputs” from the operator by means of the touch screen and, according with the command received,
activates in the appropriate sequence the other boards.
Dedicated
Processor
Signals to/from
other boards
Smart Card
input port
Touch screen
Printer Port
UI Board turned
up side down
If it is necessary to make some technical

intervention on syringe group, it is suggested to
remove it from the carriage assembly. To do that is
required to remove only 4 screws, and unplug flat
cable from the sensor’s hub board.
Internal
Sensor
Syringe (reference to
Motor calculate de
internal
displacement
of the needle
inside sample
tube)
Upper
Sensor
Syringe
Sensors
Board
Syringe
Group
Down
Sensor
13.2 – Syringe Group Replacement and/or carriage realignment (Roller 10 and 10 PN)
In this picture is possible to see the carriage group where the syringe assembly is mounted. The two holes located
in the middle of the lower part of the photo are those where syringe fixing screws are located.
In any case it is better (save time) to unmount the whole group. In this case just remove the 4 screws (indicated by
yellow circles), unplug the flat signal cable and pull out the whole assembly.
Realignment:
This procedure is useful to realign syringe group in order to centre to the sample’s tube vertical line taking as
reference the “X” axe.
First thing to do is to move up close the piston in order to have a good visuality of the position of the piston’s tip
against the sample’s tube cap. To do this it is necessary firstly login as Technical User.
As stated before, to activate this function it is necessary to be logged as “tech level” otherwise the instrument will
not allow to access the function. The tech level password requires the Technical Service Personnel
intervention in fact this kind of password must be requested to the Factory Technical Service Dept.
pressing “LOGIN” the instrument will display a keyboard to type the password, type the password: 1990 then
instrument shows the following options:
select “Syringe Auto”, this function allow to setup the excursion of the needle inside the sample tube and press
“steps” button to allow the syringe move up by steps as close as possible to the sample tube’s cap.
WRONG GOOD WRONG

ALIGNMENT ALIGNMENT ALIGNMENT
If the alignment between the piston’s tip and the sample tube’s middle line is not good (see previous page photos),
it is necessary to align the syringe group in order to centre it to the sample’s tube vertical line taking as reference
the “X” axe.
Loose the four screws that fix the whole carriage group and move gently toward left or right till the syringe reaches
the alignment with the tube’s cap. Tight again the 4screws
To move down the syringe press “Down” button,

then press “Back” till Main Screen is reached.
Now access Setup (from Main Screen)
Press “Log In - Out” (in the Setup Menu), the

instrument will display the following screen. Press
“Logout” to exit from the Technical User level and
then and “Back” till Main Screen is reached.
Now allow operator to begin to work with the instrument.
See also chapter 13.8 c for lateral alignment
13.3 –Syringe Group Replacement ONLY for Roller 20 PN
Roller 20PN instrument mount also a carriage used to move syringe group to left and right positions below each
one of the rotors; the same carriage is also used to move syringe group below the washing area infact this model
is designed also with an internal washing system that withdraw water from the washing tank using a piston pump
which moves it to the washing cell, where the needle is washed and then water is conveyed to te waste tank.
During the washing procedure peristaltic pump also withdraw water from the cell in order to wash internally the
needle and capillary.
Piston Pump
Washing Cell
Output water tube
Input water tube
Carriage
Carriage Stepper
Motor
In this picture is possible to see the carriage group

where the syringe assembly is mounted. Carriage is
mounted with 4 screws (two are marked in yellow
circles, while other two are hidden by the carriage
structure and are marked with yellow dotted circles)
To unmount the whole carriage, it is necessary to

remove the 4 screws (indicated by yellow circles),
unplug flat signal cables, unplug carriage stepper motor
power supply cable (partially hidden by the big flat
cable).
Once removed what above, it is necessary to remove

the rear panel in which are mounted the reading unit,
electro valves and peristaltic pump.
Remove 4 screws marked in red circles
Then remove capillary internal and external capillaries from rotating valve
At the and is possible to reach 4 screws that fix carriage

stepper motor to the internal chassis.
Once removed, it is finally possible to pull out the whole

carriage and piston assembly.
At this point it is possible to eventually replace carriage

stepper motor or eventually mount a complete new
group.
To reassembly the instrument follow backwards the

same procedure.
Remember once finished to reassembly the instrument,

it is necessary to execute the alignment procedure as
described in chapter 13.3 a
CARRIAGE ALIGNMENT (AVAILABLE ONLY ON ROLLER 20 PN INSTRUMENTS)
This function, if activated, is used to check and setup carriage movements on instrument with 2 rotors. Needle left
and right displacement must be aligned with the vertical axis of the corresponding left and right rotor. Furthermore,
to be perfectly aligned is also necessary to verify the needle goes inside the left and right tubes without
impediments.
Once selected this function, the instrument will display the following options:
Rotor 2:
This option moves carriage under the “right rotor”.
Rotor 1:
This option moves carriage under the “left rotor”.
Home:
This option moves carriage under the washing
lodgement that is considered also as “Home Position”.
Step Sx:
Pressing this button moves carriage 1 step Left.
Step Dx:
Pressing this button moves carriage 1 step Right.
Save:
Once verified the alignment below every position is good, pressing this button, instrument memorizes the
coordinates that will be used every time carriage moves below corresponding position.
Note: “save” function is not cumulative, must be done for each individual position; once saved the coordinate,
press the button corresponding the next position (it is suggested follow this path: Home, Rotor 1 Rotor 2) and
adjust it by pressing Step Sx or Step Dx, then press “Setup Syringe” to move close the piston to the home or
rotor position in order to check if they “match” together.
Reset All
Pressing this option, all memorized coordinates are erased and it is necessary to repeat the alignment of each
individual position, saving again once reached a good alignment between the tube and piston’s tip. The same
must be done for the home/washing position zone.
See also chapter 13.8 c for lateral alignment
13.4 – Adjusting Needle excursion inside sample tube
If necessary, is possible to adjust the internal displacement of the needle inside the tube, in this case proceed as
follows:
To activate this function it is necessary to be logged as “tech level” otherwise the instrument will not allow to
access the function. The tech level password requires the Technical Service Personnel intervention in
fact this kind of password must be requested to the Factory Technical Service Dept.
select “Syringe Auto”, this function allow to setup the excursion of the needle inside the sample tube .
• Up and Down:
is possible to set the desired excursion of the
needle inside the sample tube. The excursion is
expressed in steps.
(remember it is expressed in steps) then press the “left
arrow” to confirm or “Clear” to exit without change
anything, in both cases, the instrument will display again
the previous image.
After have set up a value, the corresponding excursion of step is also displayed.
Now pressing “Up” the needle will go up, pierce tube’s cap and goes inside the tube until reach the excursion set
previously. On the contrary, pressing “Down” (considering the needle is inside the tube) the needle comes out
from the tube and the piston goes down to home position. If the needle is already in home position, pressing
“Down” will not have any effect.
13.5 – Peripherals Hub Sensors and Boards
This hubs are used to interconnect all the peripheral sensors and signal generated and to drive them to the
belonging boards, using the Motor Board as a bridge to the other boards.
This HUB board is designed to This HUB board is designed to concentrate

concentrate signal coming from pump, signal generated by syringe sensors and send
rotor and carriage (*) sensors to the Motor and/or UI board plus washing
and send to the Motor and/or UI board pump power supply (Only Rollker 20 PN)
(*) only on Roller 20 PN (equipped with 2 x 10 samples wheels)
13.6 – Motor and Communication Boards
Motor board drives all motor inside the instrument (Rotor, Syringe and Peristaltic), while Communication board
is the interface between the instrument and outside.
Signals
to/from the
Reading Unit
Rotor and
Syringe
Power Supply
Mosfet Power
Supply
Dedicated EBCR
Processor Port
Signals
to/from the UI
Board To/Form
Host
Signals
to/from the
Syringe Board RS232
Port
Perist. Pump
Power Supply USB
Port (*)
From Main Bootloader to

Power Supply Upgrade software
Dedicated Laptop
Processor
13.7 – Peristaltic Pump
Peristaltic Pump is used to move blood from the sample tube to the Reading Unit and to discharge it inside the
waste tank. The Reading Unit is the most important part of the whole instrument, it is where the blood is
“analyzed”. This unit has 3 sensors that works indipende3ntely and give results to the Unit Interface.
Blood from
Reading Unit
Signals to Pump
to/from the
Reading Unit
Magnets
Power Mosfet to
keep the unit
thermostated at
37°C
Blood from
sample tube
Perist. Pump
Blood from
Pump to
waste tank
Rotation
Reading Unit: Dedicated Sensor
Processor
13.8 – Reading Unit
The Reading Unit has been developed to be very compact, easy to be replaced and also to be very simple to be
opened in case of a capillary replacement.
Dedicated
Processor
3 sensors
No on board adjustments (all done automatically by software)
1 dedicated DSP Processor
3 Led
In this photo are evidenced the three led, the corresponding light diffusers, while on the next photos are evidenced
the three sensors, the three collimating holes and the channel where the capillary is inserted.
3 Sensors
13.8. a – Un-mounting the Reading Unit and Capillary Replacement (Roller 10)
Remove the instrument plastic cover and also the black metallic cover, unscrewing the two upper screws to have
a good access from each side of instrument.
Now remove the needle as explained on chapter 12, then remove the piston
This operation must be done following these steps:

1. using right hand press and keep down the
knob located at the end of the piston
2. if the knob is hard to move doesn’t or doesn’t
move, rotate a bit to the left and/or to the right
the piston’s body up when the knob moves
inside the piston.
3. Keep the knob inside the piston and rotate
piston’s body toward right up when the vertical
slot of the piston is reached, now pull the
piston’s body and remove it from the syringe
assembly.
From the bottom push up the capillary,

pull out from the slot and unthread it from
the bottom of the piston support.
Then carefully pull the capillary toward the

back side of the instrument, near the
reading unit (CPS).
To “open” the Reading Unit unplug the flat signal cable and then remove 4 screws that keeps together both parts
of the Reading Unit
.
Then simply pull toward you the electronic board

and the black metallic plate to which is also
mounted the board. At this point the other half of
the unit will remain fixed to the internal chassis
while the capillary is exposed and it is possible to
proceed to replace it.
After have removed the capillary from the left part of

the reading unit, proceed to remove the capillary from
the peristaltic pump, pushing toward right the plastic
clip that keeps fixed the capillary to the pump’s body
and pull it out form its lodgement.
Repeat the same with the right side holding clamp
After have removed both sides of the
capillary from the retaining clips, rotating
manually the pump’s head remove the
capillary from inside the pump. Be careful
when removing the capillary near the home
sensor of the peristaltic pump.
At the end this is the result: the capillary and the neoprene tubing are free outside the peristaltic pump and the
reading unit. Now proceed to unthread the capillary from the waste tank. Then install the new one beginning from
the waste tank following the same path up to the peristaltic pump.
Now insert the new capillary on the left clamp, then rotate the
head (counter clockwise) and insert the other side on the right
clamp as displayed on the next photo.
Once the capillary is fixed inside the peristaltic pump, it is time to install it inside the reading unit. As displayed in
the next photo, insert the capillary inside the groove.
It is important to leave the shortest length
between the exit from the reading unit and the
peristaltic pump income.
When the capillary is fixed inside the groove,

match together both plates and then mount
again the electronic board
When mounting the electronic board BE CAREFUL to
match well both connectors, as displayed on the right
photo
Mount again the 4 screws and the plug the flat cable.
After this step pass the capillary on the right side of the
instrument toward the piston’s assembly
Insert the capillary from

the bottom passing the
head behind the
retaining ring, pull it up,
insert inside the slot
and then pull it down
allowing to take its
place inside the piston’s
head.
Now mount again the piston’s assembly pressing the knob and rotating a bit the piston in order to allow its sliding
guide enter over the knob, then mount the needle, apply again the rear cover and the plastic cover.
13.8. b –Capillary Replacement and Un-mounting the Reading Unit (Roller 10 PN and 20 PN)
Roller 10 PN and Roller 20 PN have a different system of capillary because the reading unit can receive blood
either from the internal needle or the external tip. This means external tip and internal needle uses two different
capillary lines that are then joint together before entering inside the reading unit.
To drive blood’s flow correctly, PN instruments mount a rotating valve in which blood arrives from internal needle
or external probe.
From internal needle

From external probe
To reading unit
To replace capillary from needle to rotating valve:
Remove the needle as explained on chapter 12, then remove the piston
This operation must be done following these steps:

1. using right hand press and keep down the
knob located at the end of the piston
2. if the knob is hard to move doesn’t or doesn’t
move, rotate a bit to the left and/or to the
right the piston’s body up when the knob
moves inside the piston.
3. Keep the knob inside the piston and rotate
piston’s body toward right up when the
vertical slot of the piston is reached, now pull
the piston’s body and remove it from the
syringe assembly.
From the bottom push up the
capillary, pull out from the slot
and unthread it from the
bottom of the piston support.
Then carefully pull the capillary

toward the back side of the
instrument, near the reading
unit (CPS) and then pull it up
alongside the internal chassis
up to the left side of the
rotating valve and unscrew
the connector
Then to mount the new capillary, proceed in the opposite way.
Insert the new one inside the connector and then drag the other side of the capillary to the piston and mount it as
now explained:
Insert the capillary from
the bottom passing the
head behind the
retaining ring, pull it up,
insert inside the slot
and then pull it down
allowing to take its
place inside the piston’s
head.
Now mount again the piston’s assembly pressing the knob and rotating a bit the piston in order to allow its sliding
guide enter over the knob, then mount the needle, apply again the rear cover and the plastic cover.
Replace capillary between external tip and Rotating Valve:
Carefully unscrew the plastic

connector from the electro
valve and unthread it from its
protective plastic raceway
Now gently pull out the capillary

from the withdrawing tip.
If hard to pull, cut the plastic
external sheath, and the pull
out.
To install the new capillary,
thread it inside the metallic tip,
then inside the plastic protective
raceway and then tread it on the
EV1 connector.
Finally insert a new protective
thermo restringing sheath and
with a lighter warm it to shrink it.
At the end this should be the

result:
Reading Unit capillary Replace 1:
As previously explained, Roller 10 PN and Roller 20 PN have a different system of capillary because the reading
unit can receive blood either from the internal needle or the external tip. This means external tip and internal
needle uses two different capillary lines that are then joint together before entering inside the reading unit.
To drive blood’s flow correctly, PN instruments mount two electro valves in which arrive s capillary from internal
needle and external tip. The function of this valves it better explained with this small table:
From external tip

From internal needle
1 2 To reading unit
To replace the part of capillary located between rotating valve and peristaltic pump, proceed as follows:
Unscrew capillary from rotating valve connector, then open the Reading Unit unplug the flat signal cable and then
remove 4 screws that keeps together both parts of the Reading Unit
Then simply pull toward you the electronic board

and the black metallic plate to which is also
mounted the board.
At this point the other half of the unit will remains
fixed to the internal chassis while the capillary is
exposed and it is possible to proceed to replace it.
After have removed the capillary from the left part of

the reading unit, proceed to remove the capillary from
the peristaltic pump, pushing toward right the plastic
clip that keeps fixed the capillary to the pump’s body
and pull it out form its lodgement.
Repeat the same with the right side holding clamp
After have removed both sides of the

capillary from the retaining clips, rotating
manually the pump’s head remove the
capillary from inside the pump. Be careful
when removing the capillary near the home
sensor of the peristaltic pump.
At the end this is the result: the capillary and the
neoprene tubing are free outside the peristaltic
pump and the reading unit. Now proceed to
unthread the capillary from the waste tank.
Alternatively, it is possible to replace only the part
between the “Y” connector and the exit of the
peristaltic pump, this means replace the rubber
and the Teflon tubes.
If this operation is done, remember that teflon

tube MUST ENTER INSIDE rubber tube at least
12 mm. Then install the new one beginning from
the waste tank following the same path up to the
peristaltic pump.
12 mm
Now insert the new capillary on the left clamp, then rotate the
pump’s head (counter clockwise) and insert the other side on
the right clamp as displayed on the next photo.
Once the capillary is fixed inside the peristaltic pump, it is time to install it inside the reading unit. As displayed in
the next photo, insert the capillary inside the groove.
It is important to leave the shortest length
between the exit from the reading unit and the
peristaltic pump income.
When the capillary is fixed inside the groove,

match together both plates and then mount
again the electronic board
When mounting the electronic board BE CAREFUL to

match well both connectors, as displayed on the right
photo
Mount again the 4 screws

and the plug the flat
cable.
Finally insert capillary

inside rubber tube; like
for the pump Teflon tube
must enter inside rubber
at least 12 mm.
At the end insert screw
the capillary on the
rotating valve.
13.9 – Rotor Motor, Rotor Alignment and Rotor’s Sensors
Roller 10 family has been developed thinking also to simplicity, the only mechanical adjustment is related with the
position of the rotor, compared with central line of the sample tube
Realignment:
This procedure is useful to realign rotor in order to centre to the sample’s tube vertical line taking as reference the
“X” axe.
First thing to do is (after have removed the plastic cover) is to load one sample tube in position 1and then rotate it
over the syringe assembly. To do this proceed as follows:
Log in as “tech level” otherwise the instrument will not allow to access the function. The tech level password
requires the Technical Service Personnel intervention .
To access this function, press “Log In - Out” (in the Setup Menu),
the instrument will display:
select “Rotor”, then press “Reset” to be sere the rotor

is located in home position, load one tube in position 1
and then press “take vial in position…” to select
which tube must be placed above the syringe, just type
the “number” (in this case 1) then press the “left
arrow” to confirm or “Clear” to exit without change
anything, in both cases, the instrument will display again
the previous image and move the rotor to the
corresponding position
Now look (from the left side of the instrument) through the slot if the tube is vertically aligned with the piston’s
assembly.
WRONG GOOD WRONG
ALIGNMENT ALIGNMENT ALIGNMENT
If a wrong alignment is detected, press “Reset” to move again the rotor to home position.
Then look at the home sensor position verify the

position of the magnet compared wit the position of the
sensor.
If it is necessary to adjust the position of the sensor,

proceed as follows:
Loose the two screws that fix sensor’s arm

Then move the arm slightly up or down according with:
Rotor stops forward (left photo): move sensor arm

up
Rotor stops backward (right photo): move sensor

arm down
Press again “Reset“ and then “take vial in position…” (in

this case select 1) and check if the alignment is Ok
If OK tight again the two screws and repeat one more

time the checks.
Note:
In recent models has been changed the position in where the home sensor arm is mounted on the instrument’s
internal chassis.
In the previous series, to get access to the arm’s fixing screws were necessary to remove the lateral panel
covering Motors and Communication boards, while in new instruments home sensor arm has been mounted on le
left side (see instrument frontally), so it is not necessary to remove any additional panels to adjust home sensor’s
position.
Next photos shows where are located main arm’s screws and where is located home sensor and sensor support
arm:
To align rotor proceed as explained in previous pages
13.10 – INSIDE ROLLER 10: Power Supply Board
Power Supply Boar is located on the right side of the instrument. This is a completely new designed power supply,
using a PWM switchin module and PFC ,doesn’t require a voltage selector in fact can be fed from 85 to 264 Volt.
Inside this unit there aren’t fuses or other electronic components to be checked or replaced.
Main Power
Supply
Motor
Board Comm.
Board
1. Blue: - 15 Vcd
2. Green: GND
3. Green: GND
4. Orange: + 24 Vcd
5. Green: GND
6. White: + 15 Vcd
7. Green: GND
8. Green: GND
9. Red: + 5 Vcd
10. Red: + 5 Vcd
14 – OPERATIVE SOFTWARE UPGRADE AND BOOT LOADER REINSTALLATION
INTRODUCTION
This technical note is divided in two parts: first it describes the procedure to upgrade the operating software
(tags) of Roller 10, that is the software that is used for daily operations of the instrument, while the second part
describes the reinstallation of the Boot Loader software, which is the software that is installed (in factory) at the
beginning of the operating life of the instrument. This software should be reinstalled only if the instrument doesn’t
accept anymore upgrades via serial port. Boot Loader function is only to allow the instrument to be programmed
via the serial port.
Part 1: upgrade of the operating software (tags) of the instrument.

Roller 10 instrument family has been designed for being updated also on the field, through the serial connection
using personal a computer (PC) on which has been installed the software to execute the update. New versions of
operative software (upgrade tags) will not be distributed anymore in chip (EPROM) but they will be composed by
binary files available on floppy disk, CD ROM, or sent through email or available from ALIFAX’s technical ftp site.
In order to execute the upgrade procedure it is necessary an upgrade kit composed by a serial cable, an
USB/serial adapter with drivers software and by a CD containing the program to carry the upgrade and the
operative software to be updated. This kit can be acquired with the following code:
SIR10UPG-KIT - Roller10 Software Upgrade Kit.
It is suggested to buy a kit for every technician that will operate on Roller 10’s technical assistance.
Upgrade operation very easy: connected a PC to Roller 10 through the supplied serial cable, install the upgrading
software on the PC and then run it to proceed to upgrade the operative software on the instrument.
In case of a notebook, it is required to install the USB/serial adapter’s driver and therefore to connect the serial
cable to USB/serial adapter and then to the notebook. The upgrade operations are the same sights over; once
upgraded, the instrument is ready to work with the new version (release) of the operating software.
Part 2: Re-installation of the Boot Loader software and the Display software.
The second part of this technical note describes the procedure of re-installation of the Boot Loader software. This
is the software that must be loaded using a dedicated and specific tool (programmer plus dedicated cables) to
each one of the 5 electronic boards that constitutes the instrument. This software is called Boot Loader because,
once loaded, it allows an easy and quickly upgrading of the operative software of all the 5 boards through the
serial port of the instrument and notebook.
For the re-installation of the Boot Loader it is necessary a kit that it comprises a programmer tool and its specific
cables to connect it to the electronic boards, a CD with all programs required for the installation of the Boot Loader
and also the programs contained in the CD for upgrading the operative software (SIR10UPG-KIT - Roller10
Software Upgrade Kit). It is also included a cable for the eventual upgrade of the software of the Display.
This kit can be acquired with the following code:
SIR10BL-KIT - Roller 10 family Boot Loader Kit
It is not necessary to acquire this kit, it can be required on a free loan from Alifax’s Technical Assistance in the
event of a re-installation of the Boot Loader.
The re-installation of the Boot Loader must be executed only in case of emergency, that is in the event the
instrument is not upgradeable through the serial port or if it is necessary new programming of one or more of the
electronic boards the instrument.
Once loaded the Boot Loader, it is necessary to upgrade all operative software (tags) of the instrument and then
execute a new water and latex calibration.
WARNINGS
This procedure is valid only for ROLLER10 instruments.
To avoid errors or an incorrect use, this procedure must be executed only by a technician qualified to do
maintenance on Roller 10 instruments.
14.1- OPERATIVE SOFTWARE UPGRADE (TAGS)
As explained in the introduction, this instrument uses 5 different processors that are mounted on 5 different
specific boards. To upgrade the software it is not required to replace EPROMs (like in Test 1 family instruments),
it is required only a serial cable to connect the instrument to a PC.
Required tools:
no. 01 - Personal Computer with Windows 98/ME/XP installed, a CD reader and an available serial port,
or a Notebook with CD reader and an available serial port or an available USB port.
no. 01 - SIR10UPG-KIT - Roller10 Software Upgrade Kit composed by a CD with the upgrading
software to be installed (only 1 time on the pc/notebook), one serial cable to connect the PC to Roller 10,
one USB/Serial adapter to connect a notebook to Roller 10.
Installation of the files transfer software on the PC.
This procedure must be executed only one time and install on the PC (or on a Notebook) the software that
will transfer the files with the operating program (tags) to the instrument through the serial port.
1. Switch on PC and wait the complete loading of Windows.

2. Load CD (SIR10UPG-KIT - Roller10 Software Upgrade Kit) on the CD reader.
3. Access the directory “Roller10 Programmer \requirement “.
4. Execute dotnetfx.exe (if the program is already installed, select Restore).
5. Execute langpack.exe.
6. Return to previous directory “Roller 10 Programmer”
7. Execute setup.exe leaving the options demanded during the installation unchanged.
Installation creates one new directory c:\programms\R10 BL MFC and also one new icon on the desktop with
the name R10 BL MFC.
If the installation is done on a portable PC (notebook) not equipped with a serial port, will be necessary to
install the driver of the serial-usb converter supplied in the kit.
In this phase, don’t plug the converter serial-usb to USB door, wait till the end of the driver’s installation.
In order to install the driver, access the following directory on CD: “driver USB to SERIAL” then execute the
program contained in the directory.
At the end PC will ask to reboot: switch off the PC, plug in the serial-usb converter in one available USB port of
the PC, connect the serial cable from the converter to Roller10 and switch on the PC.
14.1.1 – Operational Software Upgrade
Every software upgrade will be distributed using a file named R10-xx.yyZ.R10, where xx.yy.Z represents the
release version, (in this example, R10-01.00E.R10). This file is available inside the Software Upgrade Kit CD.
More recent releases can be requested directly to the Technical Service or downloaded from Alifax’s Technical
Ftp site. IN this case it is required to have the appropriate privileges to access the ftp site.
Once get the more recent release, the file must be copied inside the following directory: “C:\Programs\AXT\R10
BL MFC”,
1. Switch off Roller10

2. Plug the serial cable from PC (or from USB/Serial adapter) to Roller10’s serial port (if necessary unplug
the host computer cable)
3. Execute R10 BL MFC (available on desktop).
4. This window will be displayed on laptop’s screen: COM_MFC_02:
5. Select the serial port used on the PC to connect it with the Roller 10 (normally, on common PC, will be
COM1 o COM2)
6. If a USB to Serial converter is used, verify under Start / Control Panel / System / Hardware / Com and LPT
locate the USB/Serial converter identified as “Prolific USB-to-Serial Comm Port (COM xx)” where “xx”
represent the communication port. This procedure can also be used if more than one serial port is
available and it is necessary to identify its port number. Write the corresponding COM number on the field
“Porta Seriale” of the displayed window.
7. Select the appropriate software version changing the “letter” that indicates software’s release (in this
example, R10R10-01.00E.R10) then press OPEN. The program will put itself in idle waiting the switch on
of Roller10.
8. Switch on Roller10, after few seconds appear on Roller10’s display the following message: “Please wait
while downloading software” and the followed by a sliding bar that shows the uploading advancement. The
process will last about 8 minutes; after that on the laptop’s screen will appear a message telling the
upload has been successfully executed and the instrument will reboot automatically.
9. At the end of the programming, on COM_MFC_02 screen will appear a message telling the upload has
been successfully!”.
10. Press OK to close the COM_MFC_02 window.
14.2- UPGRADE OF the FIRMWARE (directly on the electronic boards)
This procedure, as indicated in the introduction, is executed in factory and it is not required to repeat unless:
• upgrade of the analogic board (for the instruments within sn. 001 to XYZ) that must be executed EVERY
TIME an upgrade of the software is executed via serial cable.
• the instrument is not more able to execute the upgrade of software through the serial cable
14.2.1 - PROCEDURE FOR THE REMOVAL OF THE COVER
Remove the screws that fix the cover using a Phillips screw driver, bend slightly toward outside
both sides of the cover and the lift up
Using the same screw driver remove both screws that fix
the rear metallic panel to the chassis and lift it up
14.3- INSTALLATION ON THE PC OF THE SOFTWARE TO PROGRAM THE ELECTRONIC BOARDS
This procedure will be used (in principle) to upgrade only, the analogic board in concomitance with the upgrade
of the operational software using the serial cable, only for the instruments from the sn. 001 until the XYZ.
This procedure will be also usable in order reinstall sw on all the electronic boards in case the instrument
is not anymore able to upgrade itself using the serial cable procedure.
Installation of the software to upgrade electronic board’s Firmware.

This installation must be done only 1 time and it is used to install on PC (or on a Notebook) the software that
will transfer firmware directly to the electronic boars mounted on the instrument.
1. Switch on PC and wait the complete loading of Windows

2. Load CD (SIR10BL-KIT - Roller 10 family Boot Loader Kit) on the CD reader.
3. Access the directory “MP750 “.
4. Run MPLAB v7.50 Install.exe
5. Select option “Complete”
6. Select directory C:\Programs\Microchip
7. Proceed with the installation
8. Return to the main directory of the CD
9. Access the folder “Roller10 Programmer \ requirement”
10. Run dotnetfx.exe (if the program is already installed, select Restore).
11. Run langpack.exe.
12. Return to previous directory “Roller 10 Programmer”
13. Run setup.exe leaving the options demanded during the installation unchanged
The software for the analogic board and the upgrading release are sent together and must be copied in the
directory “C:\Programs\AXT\R10 BL MFC”.
The supply is composed by two files:
• “R10R10-XX.YYY.R10” (XX.YYY Roller software version) used to upgrade the instrument (by means of the
serial cable)
• “R10_ANAL.hex” used to upgrade the (by means of MPLAB).
• Every time a release is received it is compulsorily to upgrade also the analogic board beyond the
upgrade made by the serial cable
14.4- INSTALLATION ON THE PC OF THE SOFTWARE TO PROGRAM THE DISPLAY
Even if this procedure is not required to for the programming of the display because it is updated during the serial
upgrade using the R10 BL MFC program, in any case it is explained how to install the software on the PC, in case it
will be necessary to execute the “first” initialization of the display.
The software for programming the display (programmable using a specific tool) is available in the CD.
1. Switch on PC and wait the complete loading of Windows

2. Load CD (SIR10BL-KIT - Roller 10 family Boot Loader Kit) on the CD reader.
3. Access the directory “setup electronic assembly lcd tool “.
4. Run setup electronic assembly lcd tools.exe
5. After the installation is possible to continue with upgrading procedures based on the specific
necessities.
14.5- PROCEDURE FOR LOADING “BOOT – LOADER” SOFTWARE ON ROLLER10 ELECTRONIC BOARDS
IMPORTANT: While the programming of the operative software from PC (with the serial cable) does not modify
instrument’s settings (configuration stored in eeprom memory), the loading of the Bootloader erases also the
eeprom memory.
To preserve eeprom’s previously stored settings, it is necessary to activate the option “preserve eeprom ":
• Access Programmer, menu select the option “settings”, choose the function “program” and activate
the function “Preserve Eeprom "
In case that option is not active, after an upgrade, it will be necessary to set again all parameters of the card that
has been already programmed.
It is suggested to printout the flag list before beginning the upgrade of the cards; in this way will be possible to set
again the parameters lost during the programming of the electronic boards.
UPGRADE KIT:
This kit is composed, beside the CD, also by:
programmer MPLAB ICD 2
one cable to program Motor, Communication and UI boards
one small cable dedicated only to program the Analogical Electronic Board
INSTRUCTIONS:
1. Plug the MPLAB ICD2 programmer to the PC by means of USB cable.
2. Connect the programmer to the electronic board to be programmed and switch on the instrument.
3. Run MPLAB program (icon on desktop).
4. If eventually required (it should be only the first time), select “installs automatically”, then firstly select the
highlighted driver and, if required, also the other driver
5. Inside Configure menu, select “select device”.
6. Choose the type of processor: dsPIC30F4013 (for the analogic board) and PIC18F8722 for the others 4
boards.
7. From menu Programmer choose option “Select Programmer” and then “MPLAB ICD2”.
8. From File menu choose option “import " and then select the file boot_xxx (xxx correspond to the board
that must be programmed) that it is available in the folder “Roller 10 Bootloader” and to press Open.
9. From menu Programmer select the option “Connect”.
10. Access menu Programmer, select the option “settings”, choose the function “program” and activate the
function “Preserve Eeprom”.
After have selected the option, appears the

windows here over. Press OK and again OK.
11. Finally from Programmer menu, choose "Program"
While the instrument’s upgrade using PC is a standard operation that every technician must know how to execute,
the re programming of bootloader software is like an extreme action, as a last attempt of recovery a not working
electronic board.
This must however be executed by a qualified technician who knows also how to reset the whole instrument
keeping in mind that all setup parameters will be lost during the programming procedure.
Thus only instruments that never had bootloader on board need of the programming of the bootloader
14.5.1 - MOTOR BOARD SOFTWARE UPGRADE
Connector motor
board.
1. Connect the programmer at the electronic board that must be upgraded and switch the instrument.
2. Run MPLAB program
3. Select option “select device” from Configure menu.
4. Select processor model: PIC18F8722
5. From Program menu, select option “Select Programmer” and then choose "MPLAB ICD2".
6. From File menu select "import" and then choose “boot_MOT.hex” which is available inside the folder
“Roller 10 Bootloader” and press Open.
7. From Programmer menu select "Connect".
8. From Programmer, select option "settings", choose "program" and activate "Preserve Eeprom".
9. From Programmer select "Program"
10. At the end, unplug the connecting cable from the electronic board port and precede with the next board if
required.
14.5.2 – UNIT INTERFACE BOARD SOFTWARE UPGRADE
U.I. Connector
6. From File menu select "import" and then choose “boot_UI.hex” which is available inside the folder
“Roller 10 Bootloader” and press Open.
10. At the end, unplug the connecting cable from the electronic board port and proceed with the next board
if required.
14.5.3 - COMMUNICATION BOARD SOFTWARE UPGRADE
Connector
6. From File menu select "import" and then choose “boot_COMM.hex” which is available inside the
folder “Roller 10 Bootloader” and press Open.
10. At the end, unplug the connecting cable from the electronic board port and proceed with the next board
if required.
14.5.4 - ANALOG BOARD SOFTWARE UPGRADE
1. Replace the cable and mount on the MPLAB ICD2 the

other cable withe the white connector (also supplied) that
must be plugged on the electronic board.
4. Select processor model: dsPIC30F4013 used only for the analog board.
6. From File menu select "import" and then choose “boot_CPS.hex” which is available inside the
folder “C:\Programs\AXT\R10 BL MFC” and press Open
10. At the end, unplug the connecting cable from the electronic board port.
14.5.5 - DISPLAY BOARD SOFTWARE UPGRADE
Jumpers to move in order

to program display board
INSTRUCTIONS:
1. Connect a serial cable between the programming tool and the PC.
2. Move towards right the two jumpers located on the display board.
3. Run “EA KIT Editor”.
4. From File menu, choose Open, select “MAIN.kmc” that is
available in the directory “setup electronic assembly lcd tools\
software_display_EN” and then press Open.
5. Switch on the instrument

6. Around row 19 is written the following code
line: “COM1: 9600”, replace COM1 with the
port number belonging to the one where it
is connected the programming tool.
7. Press F5 and confirm the modifications made. During the

programming a sliding bar appears on display; wait till the
end of the process..
8. Switch off the instrument, move the jumpers to their
original position.
IMPORTANT: only the instruments that had never had bootloader on board need of this type of upgrade.
15.0 – ERROR LIST
ERRORS THAT CAUSE INSTRUMENT’S BLOCKAGE:

Errors (error structure) Note
E X X R E S E T
E L A H H H H H
E E X H H H H H MOTOR. Switch off the instrument, wait 10 seconds and switch on again
E N D H H H H H
E 0 0 H H H H H
MOTOR. Rotor’s home sensor not detected, check if square magnet is present on the
E 0 1 H H H H H
rotor
MOTOR. Syringe’s sensor not detected, check if square magnet is present on the
E 0 2 H H H H H
piston, check if sensor detects magnet presence
MOTOR. Carriage sensor not detected, check if square magnet is present on the
E 0 3 H H H H H
carriage, check if sensor detects magnet presence
MOTOR. Not detected home sensor for peristaltic pump even after three complete
E 0 4 H H H H H
rotations, check if square magnet is present on the pump’s rotor.
MOTOR. Not detected home sensor for manual syringe , check if square magnet is
E 0 5 H H H H H
present on the manual syringe
MOTOR. Carriage position 1 sensor not detected, check if square magnet is present
E 0 6 H H H H H
on the carriage, check if sensor detects magnet presence
MOTOR. Carriage position 2 sensor not detected, check if square magnet is present
E 0 7 H H H H H
on the carriage, check if sensor detects magnet presence
MOTOR. Not detected tube’s presence during automatic syringe movement, test tube
E 0 8 H H H H H
not detected
E 0 9 H H H H H MOTOR. Not detected manual syringe Out sensor.
MOTOR. Not detected automatic syringe sensor during operations that foresees its
E 1 0 H H H H H
detection (piston sensor for + instruments).
MOTOR . Power supply falling down (n= number of reference detected low)
n=0: +33V (VREF0)
n=1: -5V (VREF1)
E 1 1 n H H H H
n=2: +8V (VREF2)
Remember to clean alarm flag after detected and restart instrument after exiting from
error procedure.
MOTOR. Nsteps set for manual syringe higher than steps required to reach run end
E 1 2 - - - - -
sensor, set again.
MOTOR. Internal Communication Protocol error, switch off the instrument, wait 10
E 1 3 H H H H H
seconds and switch on again
CPS. Internal Serial Communication Protocol error, switch off the instrument, wait 10
E 1 4 - - - - -
EXT_EEprom. Error during external eeprom access, switch off the instrument, wait 10
E 1 5 - - - - -
RTC – Error during internal communication, switch off the instrument, wait 10 seconds
E 1 6 - - - - -
and switch on again
UI (Unit Interface) – error during writing process on Unit Interface flash memory,
E 1 7 - - - - -
switch off the instrument, wait 10 seconds and switch on again
COMM. Error during internal data transmission, switch off the instrument, wait 10
E 1 8 - - - - -
COMM. Error in the internal protocol, switch off the instrument, wait 10 seconds and
E 1 9 - - - - -
switch on again
Timeout during SPI transmission to MOTOR switch off the instrument, wait 10
E 2 0 - - - - -
seconds and switch on again board
MOTOR. More than one carriage position sensor detected (low) at the same time
E 2 1 - - - - - (physically impossible!) switch off the instrument, wait 10 seconds and switch on again
board
MOTOR. (syringe) Both sensors sirup and sirdown active at the same time (physically
E 2 2 - - - - -
impossible!) switch off the instrument, wait 10 seconds and switch on again board
MOTOR. Syringe in sirdown and piston’s sensor not detected. Switch off the
E 2 3 - - - - -
instrument, wait 10 seconds and switch on again board
MOTOR. (manual syringe) Both sensors sirmanout and sirmanin active at the same
E 2 4 - - - - - time (physically impossible!) switch off the instrument, wait 10 seconds and switch on
again board
E 2 5 - - - - - MOTOR.: Printer has finished paper, load new roll.
MOTOR.: Appears after 3 failed attempts to execute the required movement (request
E 2 6 - - - - - by other board or by operator), switch off the instrument, wait 10 seconds and switch
on again board
In case one of the mentioned errors is reported, switch off the instrument, wait 10 second and then switch 0n again.
The voices: MOTOR, COMM, CPS, RTC, UI, EXT Eeprom belongs to the electronic board that compose the
instrument. This electronic boards contains parts and electronics components that CAN NOT BE
ADJUSTED BY THE LOCAL FIELD ENGINEER. It is possible just to check the
presence/absence of the square magnets on the syringe, carriage and peristaltic pump.
15.1 – SYSTEM ERROR LIST
code note: process

After three consecutive manual washings, CPS unit continues to indicate a negative
SW01 washing
result. switch off the instrument, wait 10 seconds and switch on again board
After three consecutive automatic washings, CPS unit continues to indicate a negative
SW02 washing
result. switch off the instrument, wait 10 seconds and switch on again board
One or more parameters availability is lower than -19 (roller 20) or -9 (roller 10).
SA01 Instrument indicates error. At the next availability upload, data is filtered to -19 (-9 roller autonomies
10) If upload is 1000, residues will be 981 (if -19), or 991 (if -9)
16.0 - 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 B)
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 A at each sanitation and to fill it according to the sanitation
procedure.
17.0 - SWITCHING OFF
Before switching OFF the instrument it is mandatory to use the WASHING procedure.
Then the instrument can be switched OFF using the back side push-button.
When the instrument is switched ON if the washing was done previously, the instrument prints out WASHING
PERFORMED , on the contrary the message will be WASHING NOT PERFORMED . These messages are useful
to start correctly the analytical cycle only if the washing procedure was performed.
18.0 PROGRAMMED MAINTENANCE PROCEDURE
Frequency Part to check Description of checks (please fill in the checks done)
30.000 TEST
Carriage (X axis R20PN)

□ Clean the slides from eventual grease residuals and lubricate again
with a PTFE grease or spray with silicone grease.
Syringe (Z axis) □ Check the status and the tension of belt, in particular the point of
lockage to the syringe carriage, replace it if damaged.
□ Clean and lubricate as explained for carriage (X axis).
□ Check the status of the cable of piston sensor, replace it if
damaged or folded.
Needle □ Check for any damage of the needle and replace it if damaged.
Withdrawal piston □ Remove grease residuals in the inner part of piston on the needle
support.
□ Lubricate the needle support, clean the steel flag on the side facing the
sensor.
Pump tube □ Replace it, even if it seems not damaged.
PTFE tubing □ Check the status of PTFE tubing from syringe to the reading block and
from the pump to waste tank, replace the tubing if deformed or
damaged .
□ Check if blood flow is normal and regular.
Pump □ Check the rotation of pump, pay attention to rolls are regularly rolling.
□ Verify the regularity of pressure of rolls due to springs. If some
squeaking is heard while the rolls operate, lubricate the rolls spraying
them with a bit of silicon oil.
□ Check if the magnets stuck on the head of pump are present, check
the sensor, and look if the sensor, on the commands panel, is lighted
when the magnets face the sensor during rotation.
Rotor and Sensor □ Check if the Home sensor is distant less than 2 mm from the magnet
(the optimal distance is 1 mm) and check if it is detected.
□ Adjust, if necessary the distance moving the sensor toward the rotor.
□ Check the status of belt tension of motor eventually adjust the
tension of belt . Remember that an excessive tension of belt enhances
the motor noise level during rotation.
Alignment □ Align the syringe group (carriage) with the motor group, use the racks
carriage-rotor that are used by customer. The procedure of alignment of carriage
with the rotor is described in the previous chapters.
Front door and □ Check the correct open/close of front door (open and close the doors),
Technical door check if the movement on the hinges is not altering the correct
detection of closed door by the sensor. If opening or closing of door is
not correctly detected by the sensors, check the distance between the
door frame and the sensor mechanical lever, Eventually add a small
thin layer of plastic or rubber in order to allow the door (when closed)
to push down the mechanical lever.
CPS block □ Check its calibration as described in the previous chapter 9.1.3
□ The calibration can be adjusted using the calibration kit SI 305.400,
composed by a series of optical filters and the calibration procedure.
Reset of counters □ When all the described checks are performed at the level of 30.000
test, reset the Maintenance Counter (Chapter 9.2.7.5). When reset,
the instrument will alert the operator when other 30.000 test are
performed, to call technical service. To reset the counter, enter in
RESET MENU
60.000 TEST Perform all checks reported for the 30.000 test as above described and also:
Pump speed reducer □ Check the oscillation of the reduction gear shaft into the bearings. If
the oscillation is higher than 0,5 mm evidencing also a grease leakage,
replace the reduction gear.
Repeatability check □ Execute this test loading a certain number of samples available (max
60), repeat the analysis three cycles consecutively.
□ Compare the results to verify the instrument repeatability.
19.0 – SPARE PART LIST
The next table shows the spare part list for the instrument and the suggested parts (RSP) that should be available
at your warehouse for technical service
Ord. Code Old Code Part Name RSP
SPARE PARTS FOR OPERATOR PANEL ASSEMBLY
SI20501301 Smart Card Assembly 1

SI20501901 Smart Card Flat Cable
SI20500101 User Interface Gruop with display lcd touch Screen
SI20501801 Printer assembly 1
SI20501601 Signal Flat Cable for Printer Assembly
SI20501701 Flat Cable for User Interface
POWER SUPPLY
SI20502001 Switching Mode Power Supply 115VA 1

SI20502101 Back Panel Fans, Cabled (with 2x24v coils)
SI20502201 Power Supply Cable 220V ( Mains Intlet Group-Power Supply Board )
SI20502301 Boards Power Supply Cable
SI19508001 SI 195.080-A Mains Fuses 5x20 T 2,5A (10 pcs/box) 1
SI19508501 SI 195.085-A Mains Cable
SI20502401 Mains Inlet Group, complete with fuses
MOTOR CONTROL BOARD
SI20502501 Motor Control Board 1
CARRIAGE COMPONENTS
SI20502601 Syringe Group Sensors Board 1

SI20502701 Syringe Geared Motor, cabled
SI20502801 Carriage complete assembly for ROLLER 10 ( SI R10 )
SI20502901 Carriage Flat Cable 1
SI19509101 SI 195.091-A Tube Sensor inserted into syringe support, cabled 1
Metallic Piston for CBC adapters (with conical tip, for quick and safe replacing
SI20503001 screw needle)
SI19507702 Metal Screw Needle complete of plastic replacing tool and cleaning wire (spicillum) 10
CPS MODULE ASSEMBLY
SI20503101 Preamplifier Board for CPS with photo-detector

SI20503201 Thermostat Board with high bright leds and temperature sensor
SI20501501 CPS module, visible - complete of Preamplifier and Thermostat Boards 1
SI20503301 Pump Geared Motor, cabled
SI20503401 Pump Sensor assembly 1
SI19503501 SI 195.035-A Pump Head complete ( Without SI20503401 )
SI19506001 SI 195.060-A Pump Tube kit (5 pcs. / box) 1
SI195V6201 SI 195.062/V-A Syringe to CPS "all teflon" Tube kit (5 pcs. / box) 1
SI20503701 Waste Tube (5 pcs. / box)
SI20503801 Complete tubing kit " all teflon " (5 pcs. / box) 1
SI20503901 Analogical Flat Cable
SI20504001 Thermostat Power Supply Cable
Glass Flat Light diffusor for CPS module (used on TEST1, MicroTEST1 and
SIBK732001 SI BK7.320-A Roller10-20)
MIXER TUBES ASSEMBLY
SI20504101 Sensors board DX for tubes R10 1

SI20504201 Sensors board SX for tubes R10 1
SI20504301 Home Rotor Sensor Board 1
SI20504401 Front Door Sensor, Cabled 1
SI20504501 Access syringe door sensor, cabled
SI20504601 Roller Rotor Motor, cabled
SI20505401 Rotor Toothed belt
COMMUNICATION INTERFACE
SI20504701 Communication Board

SI20504801 Communication Board cable ( from Motor control Board to Communication Board )
COLLECTOR BOARDS
SI20504901 Sensors Board Collector, above ( S205.006 )

Sensor Board Collector (Above) signal flat cable ( from pin J14 S205.002 to
SI20505001 S205.006 )
SI20505101 Sensors Board Collector, bottom ( S205.007 )
Carriage Power Supply flat cable ( from pin J5 S205.002 Board to pin J5
SI20505201 S205.007 Board )
SI20505301 Carriage Signal flat cable ( from pin J1 S205.002 Board to pin J1 S205.007 Board )
PLASTIC COVER
SI20505401 Complete Plastic Cover for ROLLER 10 (with fixing screws)
TOOLS
SIF70606 01 SI F706-F-A Tube holder clamp (tool for insert the teflon tubing into the pump rubber tubing) 1
20.0 - ROLLER – REFERENCES
Manufacturer:
SIRE Analytical Systems s.r.l.
Via Biella 121/3
33100 Udine - Italy
ISO 9001:2000 certified by TÜV Italia (n. 50 100 6107/A)
ISO 13485:2003 certified by TÜV Italia (n. 50 100 6107/B)
Worldwide distributor:
ALIFAX S.p.A.
via F. Petrarca 2
Isola dell'Abbà
35020 Polverara (PD) Italy
Tel. +39-049-0992000
e-mail info@alifax.com
web www.alifax.com
The instrument is CE certified .

According to directive 98/79/EC relative to In Vitro Diagnostic Medical Devices.
APPENDIX A - IMPROVEMENTS WITH SOFTWARE VERSIONS from 1.00A to 2.00A.
Version 1.00A
Original software version
Version 1.00B
General improvement of all the software functions and improved handling of the motor movements.
Version 1.00 C
Removed bug that at the start up time did not initialize the RS232 on host communication protocol.
Version 1.00 D
Removed bug on latex handling.
Version 1.00 E
Introduced Bootloader function on firmware.
Version 1.00 F
Removed bug on the First-up function.
Version 1.00 G
Improved software for the motor board
Version 1.00H
The same version as 1.00G but compiled in English
Version 1.00 I
Introduced option to erase maintenance counter
Version 1.00 J
The same version as 1.00I but compiled in English
Version 1.00 K
Introduced option to printout latex statistics
Version 1.00 L
The same version as 1.00 K but compiled in English
Version 1.00 M
Version not available for users, used only for experimental tests
Version 1.00 N
From this software version, updates can be done directly using a laptop PC without necessity of any special
programmer tool.
Version 1.00 O
Improved reading function on the Reading Unit software.
Version 1.00 P
Modified latex string sent to Host computer. From LATEXSTDL to LATEX0+LOT NUMBER.
Version 1.00 Q
Increased acceptability DAC range.
Version 2.00 A
Introduced Multilanguage software
Modified software for the handling of the rotating valve mounted on PN instruments.
APPENDIX B – SANITATION FORM
This module must be filled by the Laboratory / Technical Service Engineer before shipping the instrument.
This document MUST be attached to the instrument.
Description of sanitation procedures to be done by the Laboratory:
Switch ON the instrument:

OK NOK
Execute the Internal 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
If the instrument is a Roller 10PN or Roller 20PN execute also the external washing procedure
6. 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.
OK NOK
Execute the Internal washing procedure
If the instrument is a Roller 10PN or Roller 20PN execute also the external washing procedure
6. 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 the instrument and unplug it from the power supply 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
Notes:
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
DATE: __________ NAME:____________________
SIGNATURE:__________________

ROLLER 10 Technical Manual SW 2.00A - Ed. 1 Rev 2

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Doc. No: D205.07.02 UK- Ed. 1 - Rev.

In Vitro Diagnostic Medical Device for professional use

ROLLER 10 – 10PN – 20PN PRESENTATION ............................................................................................................................................1

Samples Loading Smart Card Slot

ROLLER 10 – 10PN INTERNAL VIEW

Input water tube

Retractable Tip for external

Main fuses box

MAIN Switch and Power

USB Port (future

To replace the fuses use the following procedure:

• Remove completely the fuse box

• Replace BOTH fuses (*)

• Then insert again the fuse box inside

• Finally press firmly to assure the

To remove instrument’s plastic cover proceed as follows:

ANALYSIS PRINCIPLE: Microphotometrical capillary using stopped flow kinetic analysis.

RESULTS: Given in mm/h on the range from 2 to 120 mm/h.

Sample requirements common to all three models:

Sample requirements specific for SI R10 PN / SI R20 PN in case of manual withdrawal:

General Operative performances:

Manual withdrawal (SI R10 PN model):

Operative performances for SI R20 PN instruments:

CAPACITY: Roller 10 / Roller 10 PN max 10 sample/session

ANALYTICAL PERFORMANCES (obtained with 3 ml test-tubes):

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

ENVIRONMENTAL AND PHYSICAL SPECIFICATIONS

Permissible environment conditions for operation: Temp.: from 10 to +30°C.

Permissible environment conditions for transportation

Size and weight: Width: 240 mm

Voltage: 85 - 264 Vac Power consumption: 66 W

Classification: Class I (EN61010-1 – IEC 1010-1 – CEI 66-5)

OTHER OPERATIVE SPECIFICATIONS:

Heat dissipation in the environment: about 230 BTU/hour

Noise: at low speed mixing: 55,0 db(A)

Maximum rated altitude: 3000 mt asl

Restrictions: Indoor user appliance

Rated pollution degree: Grade 2

Working life of the instrument: 10 years (if maintenance is done correctly)

INTERNAL QUALITY CONTROL

Printer Paper: Thermal roller paper 58 +0/-1 mm x Max 32 mm external diameter

Smart Card: Conform to ISO 7816-1 specifications – 85.6 x 54 x 0.8 mm

Waste Tank: 500 ml plastic waste tank with screw cap.

OPTIONAL AVAILABLE TOOLS

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

Check the instrument is connected to an efficiently ground before its use.

Follow the "WASHING PROCEDURE" for a good maintenance of the instrument.

For professional in vitro medical diagnostic use only.

The instrument is designed for indoor uses only

Use only original spare parts supplied by the manufacturer.

RISCHIO BIOLOGICO- USARE I GUANTI

PERICOLO - NON TOCCARE LA PARTE ALTA DEL PISTONE

PROCEDURE OF INSTRUMENT DISPOSAL AT THE END OF ITS OPERATIONAL LIFE

Personnel qualified for the installation

Before switching on the instrument is MANDATORY to

After switching on the instrument is MANDATORY to

• Check the availability of thermal paper

• In case of use of Sarstedt tubes, please refer to chapter 9.5.6.a

For the first installation, please refer to chapter 10

For software upgrade, please refer to chapter 11

5.0 – WASTE TANK REPLACE / EMPTY

then will check the personalization:

The possibly malfunction causes usually are: