Alifax Roller 20 Service Manual · ESR_TM_SIR20-XX_ROLLER20-SW3_2-10_EN Roller PN Service Manual Page 4 . INSTRUMENT PLASTIC COVER REMOVING . To remove instrument’s plastic cover

301-4480 Revision AA

Alifax Roller 20 Service

Manual

Rev: Ed. 2 - Rev. 10 Issue: 24.April .2014

SERVICE MANUAL

Valid for ref code: SI R20 PN with all Software Versions 3 (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 PRESENTATION ...................................................................................................................................................... 1 ROLLER PN INTERNAL VIEW ................................................................................................................................................ 1 ROLLER REAR SIDE VIEW .................................................................................................................................................... 3 INSTRUMENT PLASTIC COVER REMOVING ........................................................................................................................ 4 1.0 – ROLLER PN TECHNICAL SPECIFICATIONS ESR_PTDS_SI205_ROLLERPN_2-4_EN 2014-Janwary-31 ......... 5 2.0 - WARNINGS ...................................................................................................................................................................... 9 2.1 INDEX OF SYMBOLS ....................................................................................................................................................... 11 3.0 - UNPACKING AND INSTALLATION ............................................................................................................................... 12 4.0 – PRELIMINARY CHECKS, FIRST INSTALLATION AND SOFTWARE UPGRADE ....................................................... 13 5.0 – WASTE TANK REPLACE / EMPTY .............................................................................................................................. 13 6.0 – WASHING TANK LEVEL CONTROL............................................................................................................................. 13 7.0 – INCREASE AVAILABILITY TEST USING THE SMART CARD ..................................................................................... 14

7.1 – SMART CARD ERRORS ................................................................................................................................................................................ 16 7.2 – MULTIPARAMETRIC CARDS ....................................................................................................................................................................... 16 7.2 – PAPER ROLL LOADING - REPLACEMENT .............................................................................................................................................. 17

8.0 – SWITCH ON .................................................................................................................................................................. 18 9.0 – MENU DESCRIPTION ................................................................................................................................................... 18 9.1 – MAIN MENU .................................................................................................................................................................. 19 9.1.1 – MEASURE MENU ....................................................................................................................................................... 19 9.1.1.1 – PATIENT IDENTIFICATION BY External Bar Coded Reader .................................................................................. 20 9.1.1.2 – MANUAL INSERTION OF THE PATIENT ID ........................................................................................................... 21 9.1.1.3 – AUTOGENERATED ID ............................................................................................................................................ 22 9.1.1.4 – RESTORE LAST SESSION ..................................................................................................................................... 23 9.1.1.5 – EXTERNAL SAMPLING PROCEDURE, USING INTERNAL MIXING ..................................................................... 24 9.1.1.6 – EXTERNAL SAMPLING WITHOUT INTERNAL MIXING ........................................................................................ 26 9.1.1.7 – ANALYSIS RESULTS (Display and Printouts) ......................................................................................................... 28 9.1.1.8 – ANALYSIS RESULTS DURING SECOND TAKE OF SAMPLE AND SAMPLE MISSING ....................................... 29 9.1.2 – WASH MENU.............................................................................................................................................................. 30 9.1.2.1 – INTERNAL WASH ................................................................................................................................................... 30 9.1.2.2 – AUTOMATIC WASH ................................................................................................................................................ 31 9.1.2.3 – EXTERNAL WASH .................................................................................................................................................. 32 9.1.2.4 –WASHINGS PROCEDURE DESCRIPTION ............................................................................................................. 33

WASHING USING 2 TEST TUBES ........................................................................................................................................................................ 33 WASHING USING 3 TEST-TUBES (optionally third tube filled with a detergent liquid) ............................................................................... 34 WASHING PROCEDURE FOR MAINTENANCE ................................................................................................................................................ 34 9.1.2.5 WASHING PROCEDURE IN CASE OF USE OF LATEX CONTROLS ........................................................................................... 35

9.1.2.6 – END OF WORKING DAY WASHING PROCEDURE (Wash and Sleep) ................................................................. 36 9.1.2.7 – WASHING ERRORS ............................................................................................................................................... 37 9.1.2.8 –WASHINGS PROCEDURE ERRORS (MEANING OF WASHING FLAGS IN DEBUG ON) .................................... 37 9.1.3 – STANDARD (Latex control / calibration) ..................................................................................................................... 40 9.1.3.a – BoosterY adjustment when comparing against Westergreen Method ..................................................................... 45 9.1.4 – MIXER ........................................................................................................................................................................ 47

9.1.5 – EMPTY ROLLER ........................................................................................................................................................ 47 9.1.6 – INTERNAL QUALITY CONTROL ............................................................................................................................... 48 9.1.6.1 – WASHING QUALITY CONTROL PRINTOUT - Graph meaning .............................................................................. 49 9.1.6.2 – “NORMAL” ESR AVERAGE CONTROL PRINTOUT - Graph meaning ................................................................... 50 9.1.6.3 – “GLOBAL” ESR AVERAGE CONTROL PRINTOUT - Graph meaning .................................................................... 52 9.1.6.3.b – INTERPRETATION OF THE STATISTICAL MEANING ....................................................................................... 54 9.1.6.4 – “NORMAL” CUMULATIVE ESR DISTRIBUTION PRINTOUT - Graph meaning ..................................................... 56 9.1.6.5 – “GLOBAL” CUMULATIVE ESR DISTRIBUTION PRINTOUT - Graph meaning ...................................................... 57 9.1.6.6 – “NORMAL” DAILY ESR DISTRIBUTION PRINTOUT - Graph meaning .................................................................. 58 9.1.6.7 – “GLOBAL” DAILY ESR DISTRIBUTION PRINTOUT - Graph meaning ................................................................... 59 9.1.6.8 –INSTRUMENT VERIFICATION USING THE LATEX CONTROL KIT ...................................................................... 60 9.1.6.9 – ERASE STATISTICAL DATABASE ......................................................................................................................... 63 9.2 – SETUP MENU ............................................................................................................................................................... 65 9.2.1 – CPS MENU ................................................................................................................................................................. 65 9.2.1.1 – CPS’ PARAMETERS ............................................................................................................................................... 65 9.2.1.1.a – MODIFY TYPE OF REFERENCE (CHOOSE BOOSTERY TYPE) (Technical password required) ..................... 66 9.2.1.1.b – MODIFY BOOSTERY’s VALUE (Technical password required) .......................................................................... 67 9.2.1.1.c – MODIFY WHOLE PARAMETRES’ VALUES ....................................................................................................... 68 9.2.1.1.d – MODIFY MODEL FACT’s VALUES (Technical password required) .................................................................... 68 9.2.1.1.e – MODIFY Offset Sensors VALUES (Technical password required) ...................................................................... 68 9.2.1.1.f – MODIFY THERMOSTAT reference value (Technical password required) ............................................................ 69 9.2.1.2 – CPS Correctors Parameters (Available only if a Multiparametric card is used) (Technical password required) ....... 69 9.2.1.3 – CPS Read ADC ....................................................................................................................................................... 70 9.2.1.4 – FIRST UP ................................................................................................................................................................ 70 9.2.2 – MIX MENU .................................................................................................................................................................. 70 9.2.3 – DATE TIME MENU .................................................................................................................................................... 71 9.2.3.1 – MODIFY DATE TIME VALUE (User level password required) ................................................................................ 71 9.2.4 – FL (Flag List) MENU ................................................................................................................................................... 73 9.2.5 – SETTINGS MENU ...................................................................................................................................................... 75 9.2.5.1 – SOFTWARE VERSION ........................................................................................................................................... 75 9.2.5.2 – PRINT EXPANDED ................................................................................................................................................. 75 9.2.5.3 – PRINT IN RUN ......................................................................................................................................................... 76 9.2.5.4 – LANGUAGE SETUP ................................................................................................................................................ 76 9.2.6 – SETTINGS MENU with “USER LEVEL” PASSWORD LEVEL ACCESS .................................................................... 76 9.2.6.1 – WASH TIME ............................................................................................................................................................ 77 9.2.7 – SETTINGS MENU with “TECHNICAL LEVEL” PASSWORD LEVEL ACCESS .......................................................... 77 9.2.7.1 – INSTRUMENT SERIAL NUMBER ........................................................................................................................... 78 9.2.7.2 – DEBUG .................................................................................................................................................................... 79 9.2.7.3 – CONFIGURATION OF KIND OF ROLLER (Available from software version 1.00N) ............................................... 79 9.2.7.4 – MAINTENANCE LEVEL RESET .............................................................................................................................. 80 9.2.7.5 – MAINTENANCE LEVEL THRESHOLD SETUP ....................................................................................................... 80 9.2.7.6 – INSTRUMENT GENERAL RESET .......................................................................................................................... 81

9.2.7.7 – PRINT PARAMETERS ............................................................................................................................................ 81 9.2.7.8 – 2 CPS ...................................................................................................................................................................... 82 9.2.7.9 – LATEX PRIMING ..................................................................................................................................................... 82 9.2.7.10 – SYRINGE FAST ..................................................................................................................................................... 82 9.2.7.11 – PEDIATRIC SAMPLES .......................................................................................................................................... 83 9.2.7.12 – ERROR LOG ......................................................................................................................................................... 83 9.2.8 – LOG IN-OUT ............................................................................................................................................................... 84 9.3 – AVAILABILITY MENU .................................................................................................................................................... 85 9.3.1 – WARNING LEVEL (User level password required) ..................................................................................................... 85 9.3.2 – DISPLAY AVAILABILITY ............................................................................................................................................ 86 9.4 – COMM MENU (Technical password required) ............................................................................................................... 87 9.4.1 – SETUP MENU ............................................................................................................................................................ 88 9.4.1.1 – INSTRUMENT NUMBER ......................................................................................................................................... 88 9.4.1.2 – TIMEOUT ................................................................................................................................................................. 89 9.4.1.3 – ATTEMPTS .............................................................................................................................................................. 89 9.4.1.4 – MISSING ID ............................................................................................................................................................. 90 9.4.1.5 – DO ON TIMEOUT UART ......................................................................................................................................... 90 9.4.1.6 – ACK ......................................................................................................................................................................... 90 9.4.1.7 – BAYER (only with BCI interface) .............................................................................................................................. 91 9.4.1.8 – 6 Parameters Transmission (under development). .................................................................................................. 91 9.4.1.9 – Curve Parameters Transmission (under development). ........................................................................................... 91 9.4.1.10 – PROTOCOL INTERFACE OPTIONS .................................................................................................................... 92 9.4.1.10.a – DAT 8 INTERFACE (NO QUERY) ...................................................................................................................... 93 9.4.1.10.b – DAT 15 INTERFACE (NO QUERY) .................................................................................................................... 94 9.4.1.10.c – BCI INTERFACE (QUERY) ................................................................................................................................. 95 9.4.1.10.d – No HOST ............................................................................................................................................................ 95 9.4.1.11 – PROTOCOL INTERFACE EXPLICATION ............................................................................................................. 95 9.4.1.12 – LATEX PROTOCOL INTERFACE EXPLICATION................................................................................................. 97 9.4.1 – TEST MENU ............................................................................................................................................................... 98 9.5 – TECH MENU (Technical password required) ............................................................................................................... 100 9.5.1 – PUMP CONFIGURATION ........................................................................................................................................ 101

• Internal taking: ....................................................................................................................................................................................................... 101 • External taking: ..................................................................................................................................................................................................... 101 • Fast: ........................................................................................................................................................................................................................ 102 • Retention: ............................................................................................................................................................................................................... 102 • Reset persistaltic: ................................................................................................................................................................................................. 102 • Wash pump: .......................................................................................................................................................................................................... 102

9.5.2 – SYRINGE AUTO ....................................................................................................................................................... 103 • Up and Down: ........................................................................................................................................................................................................ 103 • Up in Wash: ........................................................................................................................................................................................................... 103

9.5.3 – SYRINGE MAN ......................................................................................................................................................... 104 9.5.4 – CARRIAGE ALIGNMENT (AVAILABLE ONLY ON ROLLER 20 PN/LC INSTRUMENTS) ....................................... 105 9.5.5 – ROTOR ..................................................................................................................................................................... 106 9.5.6 – SENSORS ................................................................................................................................................................ 107

9.5.6. a – ROTOR ADJUSTMENT FOR SARSTEDT TUBES .............................................................................................. 107 10.0 – FIRST INITIALIZATION AND STARTUP ................................................................................................................... 109 11.0 – LATEX CALIBRATION ............................................................................................................................................... 111 12.0 – NEEDLE REPLACE ................................................................................................................................................... 119 13.0 – ROLLER Start-Up Sequence and Boards Description ............................................................................................... 123 13.1 – UI Board and Syringe Group ...................................................................................................................................... 127 13.2 – Syringe Group Replacement and/or carriage realignment ......................................................................................... 128 13.3 –Syringe Group Replacement ONLY for Roller 20 PN .................................................................................................. 131 13.4 – Adjusting Needle excursion inside sample tube ......................................................................................................... 133 13.5 – Motor and Communication Boards ............................................................................................................................. 135 13.5.1 – Motor Boards Details ............................................................................................................................................. 136 13.6 – Peristaltic Pump ......................................................................................................................................................... 139 13.7 – Reading Unit (CPS) ................................................................................................................................................... 140 13.8. a – Un-mounting the Reading Unit and Capillary Replacement (Internal Circuit) ......................................................... 141 13.8. b –Capillary Replacement and Un-mounting the Reading Unit (External Circuit) ........................................................ 146 13.9 – Rotor Motor, Rotor Alignment and Rotor’s Sensors ................................................................................................. 147 13.10 – INSIDE ROLLER 10: Power Supply Board .............................................................................................................. 151 14 – SOFTWARE UPGRADE ............................................................................................................................................... 152 14.1 – Operative Software Upgrade ...................................................................................................................................... 152 15.0 – ERROR LIST ............................................................................................................................................................. 155 16.0 - SANITATION PROCEDURE ...................................................................................................................................... 157 17.0 - SWITCHING OFF ....................................................................................................................................................... 157 18.0 PROGRAMMED MAINTENANCE PROCEDURE ........................................................................................................ 158 19.0 – SPARE PART LIST.................................................................................................................................................... 160 20.0 - ROLLER – REFERENCES ........................................................................................................................................ 163 APPENDIX A - IMPROVEMENTS WITH SOFTWARE VERSIONS from 1.00A to 3.X ....................................................... 163 APPENDIX B – SANITATION FORM ................................................................................................................................... 166

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.

ESR_TM_SIR20-XX_ROLLER20-SW3_2-10_EN Roller PN Service Manual Page 1

ROLLER PRESENTATION

ROLLER PN INTERNAL VIEW

Smart Card Slot

Touchscreen LCD

Printer

Samples Loading Door

Open Lever

Waste Tank

Piston and Carriage Assembly

Rotor with 20 positions

Capillary

Washing Tank for internal

washing options

Discharge tube from the

washing cell

Needle Washing Cell

Input water tube

Washing pump

Carriage Stepper Motor


Retractable Tip for external withdraw (useful for tubes with

plastic cap and/or paediatric tubes)

External Tip motor


ROLLER REAR SIDE VIEW

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

• Remove completely the fuse box and replace BOTH

fuses (*)

• Insert again the fuse box inside the Main Switch block pressing it firmly to assure the box’s tongue fits on the hook.

(*) The fuse which is placed in appliance inlet shall be replaced only by a T5,0 A L 250 V dimensions 5x20 mm or T5,0 A H 250 V dimensions 5x20 mm. A T5,0 Ampere fuse; it is suitable for both 115 and 230 Vac.

MAIN Switch and Power Supply Plug.

Voltage: 115 – 230 Switch Mode Power Supply

(SMPS) Power Supply Fan Intakes

EBCR Serial Port

HOST Computer Serial

Port

USB Port (future applications)

Main fuses box

Instrument cooling Fan and Cooling Fan Intakes


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, there are also two screws located below the loading door, these also must be removed, then unthread the metallic cover pulling toward you and then lifting up.


1.0 – ROLLER PN TECHNICAL SPECIFICATIONS ESR_PTDS_SI205_ROLLERPN_2-4_EN 2014-Janwary-31

NAME: Roller20PN - Code SI R20 PN DESCRIPTION: Automatic Analyzer for the determination of human blood Erythrocyte Sedimentation Rate (ESR).

Model with 2 rotors for 20 samples total equipped with an automatic washing system and manual external withdrawal tip for pediatric test-tubes and for test tubes that can be uncapped.

ANALYSIS PRINCIPLE: Microphotometrical capillary using stopped flow kinetic analysis. RESULTS: Given in mm/h in the range from 2 to 120 mm/h. SAMPLE REQUIREMENTS: Sample requirements in case of automatic withdrawal:

- the sample must be of whole blood collected in EDTA anti-coagulant. - the blood sample must be neither coagulated nor hemolyzed. - it would be better to test the sample within 4-6 hours from venipuncture or within 24 hours if kept

at +4 / +8 °C, allowing it to warm-up to room temperature before testing. - the minimum blood volume for the withdrawal (dead volume) is 800 microliters - the minimum blood working volume required for the analysis is about 175 microliters except for

the first two samples from which supplementary 116 microliters are approximately 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 inside the capillary by air bubble. Sample requirements in case of manual withdrawal:

- the minimum blood working volume required for the analysis is about 100 microliters, except for the first sample from which supplementary 100 microliters are approximately withdrawn for priming.

- samples separation inside the capillary by air bubble. TUBE REQUIREMENTS: Test-tubes 13x75 mm like BD Vacutainer® or BD Microtainer® 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 Operative performances:

• New design with thermoplastic cover, front door for easy access to waste and washing tanks and to the needle. • Simplified and safe needle replacing procedure. • Simplified Smart Card downloading. • Photometer check after each washing, to ensure continuous control of the instrument. • New photometer (CPS) with three detectors for ESR analysis and blood flow management. • New automatic washing programmable at the end of each cycle. • New withdrawal tip for pediatric test-tubes and for test tubes that can be uncapped. • To compare the ESR testing between manual and automatic procedure performed with Roller 20 PN it is mandatory to

open the cap of the tube both for automatic - manual procedure and vice versa • Management of Latex Controls kits for TEST1 family analyzers (Ord. code SI 305.100-A/SI 305.102-A and SI

305.300-A/ SI 305.302-A).


Automatic withdrawal: • Samples mixing can be programmed in three speeds (60, 32 and 26 RPM) and in number of rotations, from 2 to 1000

rotations (recommended 32 RPM @ 140 rotations, about 4,2 minutes mixing). • First result available after 4,2 minutes (mixing) and 30 seconds (analysis), the other results are given every 30 seconds

each; 20 samples processed in about 10 minutes (120 samples per hour) without considering the time taken for loading and unloading of test-tubes from the instrument. With Syringe fast enabled, mixing time is the same, but analysis time reach 24 seconds per sample, and so 20 sample are processed in about 8 minutes. The above throughput could be delayed in case of connection to the Host Computer with reply output time more than 1 second.

Manual withdrawal: • Samples mixing can be programmed in three speeds (60, 32 and 26 RPM) and in number of rotations, from 2 to 1000

rotations (recommended 32 RPM @ 140 rotations, about 4,2 minutes mixing). • First result available after 4,2 minutes (mixing) and 30 seconds (analysis), the other results are given every 30 seconds

each. This times are considered without including the time taken for loading and unloading the test-tubes from the instrument and also for uncapping and recapping the test-tubes.. The above operation could be delayed in case of connection to the Host Computer with reply output time more than 1 second.

Error notice: The instrument in case of error or malfunction, reports this situation with a specific message on the screen plus with an acoustic intermittent signal of 62,5 dBA.

CAPACITY: max 20 samples/session ANALYTICAL PERFORMANCES (obtained with 3 ml test-tubes):

Agreement with TEST1: R2 = 0.91

Repeatability: mean CV% = 5.7% on the whole range 2 - 120 mm/h Reproducibility: mean CV% = 5.1% on the whole range 2 - 120 mm/h

Stability of samples stored for 24 h at room temperature: In order to view the effects of different methods of storage on the ESR value, 272 K3EDTA-anticoagulated whole blood samples, some of which have been stored at 4 °C and some others at room temperature, have been analyzed after 4 hrs and after 24 hrs on TEST1 device. Good correlation was found between the results taken at 4 hrs and those taken at 24 hrs on the samples stored at 4 °C (r=0.980). Those stored at room temperature did not correlate quite as well as those stored at 4 °C, but still had very good correlation (r=0.917)(1).

METHOD LIMITATIONS: 1. The erythrocyte sedimentation rate is a phenomenon confined to fresh blood and transient(2), 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.)(2). Based on the acquired experience,TEST1 family instruments (TEST1, MicroTEST1, Roller), 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)… (2) that is affected by several technical aspects (3). The ESR is often normal in patients with cancer...(3).

International guidelines for diagnosis and management of multiple myeloma do not mention the Erythrocyte Sedimentation Rate (4). It is then necessary to point out that even though TEST1 analytical performances have been confirmed in patients affected by multiple myeloma (5,6), there have been some cases of patients affected by multiple myeloma in which TEST1 has reported clinically negative ESR values in comparison to other methods. Based on this experience there could be cases in which Roller gives low ESR results likewise TEST1 in presence of Multiple Myeloma. It is then highly recommended to perform other tests together with the ESR in the diagnosis of cancer since a normal ESR value is not enough to exclude that the patient is not affected by this pathology.


Furthermore in presence of this disease it is possible to observe deviations form other methods since other phenomena in addition to the rouleaux formation can contribute to the sedimentation like for example amorphous aggregates formation (crystallization of paraproteins or mineral materials like calcium) resulting from bone tissue alteration.

3. Samples mixing is programmed at the beginning of the analysis with the purpose of disaggregating erythrocytes. An inefficient disaggregation or micro-clots presence can affect the 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: 16 Kg

ELECTRICAL SPECIFICATIONS

Voltage: 115 - 230 Vac Power consumption: 115 VA Switch Mode Power Supply (SMPS) Switch on cons: 132 W Frequency: 50/60 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 (for 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’s and sensors’ life.

Restrictions: Indoor user appliance Rated pollution degree: Grade 2 Working life of the instrument: 10 years (if maintenance is done correctly)


INTERNAL QUALITY CONTROL Latex Controls: Latex Controls for TEST1 family analyzers allow the control of the calibration stability of

TEST1, MicroTEST1; Roller and JO-PLUS. 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 TEST1 Family Quality Control: it is a software (code SI195620) designed to collect and process the data from one or more

TEST1 family analyzers (TEST1, MicroTEST1, Roller) 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 195901) - 4,000 (Ord. code SI 195904) - 10,000 (Ord. code SI 195910) - 20,000 (Ord. code SI 195920) tests / Universal Card for TEST1 family analyzers (TEST1; MicroTEST1; Roller).

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 (SI195820)

REFERENCES:

1. E. Heverin (Galway-Mayo Institute of Technology, Ireland): ”Comparison of the Westergren method versus the TEST1 technique for determining the Erythrocyte Sedimentation Rate”, May 2002, private communication

2. NCCLS “Reference and Selected procedure for the Erythrocyte Sedimentation rate (ESR) Test; Approved

Standard-Fourth Edition”, Vol. 20 No. 27

3. Sox HC, Liang MH: “The Erythrocyte Sedimentation Rate”, Annals of Internal Medicine 1986; 105:515-523.

4. NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology “Multiple Myeloma” (V.I.2007)

5. Ajubi et al.: “Determination of the lenght of sedimentation reaction in blood using the TEST1 system:

comparison with the Sedimatic 100 method, turbidimetric fibrinogen levels, and the influence of M-proteins”, Clin Chem Lab Med 2006; 44 (7): 904-906

6. Mercurio S. et al.: “Comparison between two methods for ESR measure in patients affected by myeloma”, 37° SIBioC National Congress, 11-14 October 2005 Rome.


7.

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.

Is absolutely forbidden exchanging any electronic board from one instrument to another instrument.

This instrument is not intended for use by persons with reduced physical, mental and sensorial capabilities or lack of experience and knowledge, unless they have been given supervision or preliminary instructions for the use of the analyzer by a person responsible for their safety.

The instrument has to be installed on a dry surface sheltered from sun light to avoid sun rays hit the door sensor when the door is open generating unplanned consequences.

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)

In case of use of the external withdrawing tip, it is mandatory to clean it following the washing procedure in order to avoid blood dries inside the tip causing the formation ob blood clogs inside it. The tip must be washed within 10 minutes before last sample analysis.

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 windrowing probe).

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 metallic or electronic parts are damaged, ask for the immediate replacing of them. This will be done supplying original spare parts especially for the mains parts (power cord, mains group, power switch) .

The instrument, can be exposed to potential infective materials. It’s, therefore, compulsory to adopt all the precautions and the necessary warnings, in accordance with national laws, which apt to avoid any physical contact.

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 …)

Prior to install and use the instrument for the first time, it is suggested an evaluation of the electromagnetic environment

Do not use the instrument in proximity of sources of strong electromagnetic radiations (e.g. mobiles, CB’s, radio transmitting units and similar or unshielded intentional RF sources) as these may interfere with the proper operation of the instrument

In order to avoid possible mistakes in the Query-Host communication and/or the transmission of patient ID to the Host computer, it is recommended the use of bar-code codification which includes the “check-digit” option in its protocol.

Battery for Unit Interface board SI205001 (S25.001x) is Kinetic #MH60B3AL3; Ni MH; 3,6V 60 mAh

Instrument is compliant with IEC 61326 emissions and immunity requirements

THE FOLLOWING LABELS ARE STUCK AS WARNINGS ON THE INSTRUMENT AND MUST NOT BE REMOVED..

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.


2.1 INDEX OF SYMBOLS

Inside this manual and also on the instrument can be find many internationally used symbols, here we describe the meaning of this symbols:

Symbol Meaning Symbol Meaning

_ REF _ Product code

Attention, see instructions for use

Manufacturer

Ground terminal lug on the equipment.

In Vitro Diagnostic Medical Device

SN

Serial Number

Caution: Moving Parts Inside

Caution: Biological Risk

Caution: Laser Radiation

Caution: High Voltage

Caution: Sharp Objects Inside


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 16 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 family uses an internal control system to check the level of waste tank:

• 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.

• 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

This tank doesn’t have any kind of liquid level control, it is suggested at least once per day check the level of washing water inside the tank.

45 mm


7.0 – INCREASE AVAILABILITY TEST USING THE SMART CARD

Roller 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 ESR parameter, display will show a warning message requiring to increase the availability. All the other test will be also automatically increased. Instrument allows to go in negative availability only one time; supposing the ESR availability is 1, instrument allows to run up to 20 samples and goes in a negative availability of -19; at the next test increase, the availability of test will be discounted by 19 tests. 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, only for the credits enabled:

then will check the personalization, the number of credits and which type of credit are enabled:

• If the instrument’s personalization is different from the one programmed in the card it will reject the card. Then after pressed “OK” the instrument asks to remove the card and comes back to Main Menu. In this case the credits don’t increase.


• If the instrument have no personalization, it will acquire the one set in the smart card. Then after pressed “OK” the instrument asks to remove the card and comes back to Main Menu. In this case the credits increase as is possible to see in the printout.

• If the personalization is the same as the one stored in the card, the instrument, after pressed “OK”, asks to remove the card and comes back to Main Menu. In this case the credits increase as is possible to see in the printout.

r If, for some reason, the card inserted is defective the instrument will show a message informing about that, then after pressed “OK”, the instrument asks to remove the card and comes back to MAIN MENU. 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 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

GOOD WRONG


7.2 – PAPER ROLL LOADING - REPLACEMENT In the event the paper ends, instrument shows on screen a message informing paper has ended

Replace the roll is simple and quick:

Pull the plastic lever of the printer, lift up the plastic cover and remove the plastic core (is present) of the old roll

Keep the plastic cover up and insert the new roll of paper being sure to pull it a bit in order to allow paper being captured and pressed by printer’s rubber roll.

Close the plastic cover and press the “advance paper” button to check if paper is coming out correctly; after that press OK on the display

Wait while instrument finish the internal checks; at the end Main menu will be displayed


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 20 PN)

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)

• More: allows accessing to some info, like useful information and technical phone numbers, or to the data of the last session

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, offers these possible options:

• Internal normal withdrawing; • Internal pediatric withdrawing (only if pediatric flag is enabled); • External normal withdrawing; • External pediatric withdrawing (only if pediatric flag is enabled); • External withdrawing without mixing.

Then, independently from the option previously chosen, the instrument checks the state of the rotor, controls the level of the waste tank, controls the availability of credits and requires to identify and load the samples to be analyzed.


9.1.1.1 – PATIENT 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 “Back” is possible to 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: Start: The instrument will start the analysis cycle Back: Will ask to remove all the previous inserted tubes, checking one by one they has been removed


9.1.1.2 – MANUAL INSERTION OF THE PATIENT ID

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.

If by mistake has been written the wrong patient ID, just pressing “Back” is possible to write 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.



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.

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.



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]

[Cycle number] [Sample position] 9.1.1.4 – RESTORE LAST SESSION This function allows to restore the last session, in case of the instrument is switched off for mistake, for an error or for a black out. Notice that this function doesn’t work for external withdrawing without mixing. When this occurs, after switched on the instrument again, it after few second asks this question: “Restore last session?”

Then, is possible to choose if restore the session or no, in fact, pressing “YES” button, the instrument starts to mixing the champions and after continues with the interrupted session analysing the champions remaining. Otherwise, pressing “NO” or “Back” button, the instrument definitively aborts the current session, asks to remove the champions and comes back to main menu. In any case, when the instrument comes back to main menu, is possible to see the results of the last session, pressing “Last session”, inside menu More.

0307920106


9.1.1.5 – EXTERNAL SAMPLING PROCEDURE, USING INTERNAL MIXING 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. In case the option chosen is external sampling normal or pediatric (with internal mixing), 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.

ONLY If the analysis is done after a washing procedure, the instrument will execute a “Priming procedure”.

For the priming procedure, instrument 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 1 and withdraw a small quantity of blood for the priming. Take out tube from position 1, uncap, insert inside the external probe and press START. Instrument will take a small amount of blood form the tube, then it will issue 3 beeps, this means the tube MUST be removed from the probe. Next the blood is moved inside the reading unit to prepare the capillary receive the blood. Meanwhile instrument asks to reload tube in position 1 and continues with the mixing cycles till reaches the programmed mixing cycles. Note: Only with pediatric session, is possible to do priming with pediatric champions, with normal session, is mandatory to use a normal champion (adult champion) for the priming, in order to don’t waste pediatric champions.

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. At the end of the priming procedure, the tip come back to home position.


After the instrument has finished the mixing, will ask to remove from rotor the tube, then the probe will be moved out and (after having uncapped) insert the tube over the probe all the way down. Next just press START.

Note; 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. During the analysis, 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.

Then the instrument will move the rotor to the next position and will ask to pick the next sample to be analyzed. During the session 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.

IMPORTANT: In case of use of the external withdrawing tip, it is mandatory to clean it following the washing procedure in order to avoid blood dries inside the tip causing the formation ob. blood clogs inside it. The tip must be washed within 10 minutes before last sample analysis.


9.1.1.6 – EXTERNAL SAMPLING WITHOUT INTERNAL MIXING 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. In case the option chosen is external sampling WITHOUT MIXING,

Then, ONLY If the analysis is done after a washing procedure, the instrument will execute a “Priming procedure”.

For the priming procedure, take a tube, uncap, insert inside the external probe and press START. Instrument will take a small amount of blood form the tube, then it will issue 3 beeps, this means the tube MUST be removed from the probe. Next the blood is moved inside the reading unit to prepare the capillary receive the blood. Meanwhile instrument asks to reload tube in position 1 and 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) 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 the priming, instrument asks to identify the sample to be analyzed; as for the previous cases, the option are:

• Autogenerated ID • Manual ID (typed manually) • EBCR

Once pressed OK instrument asks to sample the tube just identified previously; after pressing START the instrument will aspire the blood. In case of mistake, pressing the “BACK” button (not visible in the photo here displayed) instrument returns to previous screen were user can re-insert the ID.

Note; when the aspiration is finished,

instrument will beep 3 times, this means the tube must be removed from the external tip and recapped.

During the analysis, 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.

At the end of the analysis, instrument show on the screen the result (and also print it if the flag “print in run” is enable), than after press OK button, reappears the ID insertion screen and so you can choose if analyse another sample, or pressing BACK button, to end the session.

IMPORTANT:


In case of use of the external withdrawing tip, it is mandatory to clean it following the washing procedure in order to avoid blood dries inside the tip causing the formation ob. blood clogs inside it. The tip must be washed within 10 minutes before last sample analysis. 9.1.1.7 – 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 session is reported: Date and time of analysis Session number (01 = first session of day) Then for each sample is printed its position inside the rotor, patient’s ID and the 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.


9.1.1.8 – ANALYSIS RESULTS DURING SECOND TAKE OF SAMPLE AND SAMPLE MISSING This function allows, in case of the champion value is not detectable [NF (-4) / NR (-2)], to try a second taking. With external withdrawing (normal, pediatric or without mixing) the instrument asks to following a specific procedure. When the value of one sample is not detectable, the instrument shows this screen: Then, is possible to choose if analyse again the sample or no, in fact, pressing “YES” button, the instrument asks to analyse again the sample and after pressing “START” button, is executed again the analysis procedure. Otherwise, pressing “NO” or “Back” button, the instrument doesn’t analyse again the sample and then shows, prints and sends to host (if is present) the value NF (-4) or NR (-2). With internal withdrawing (normal or pediatric) the instrument does this operation automatically, moving the motors and analyzing the sample again. Also with this kind of withdrawing, if the second attempt fails, the instrument shows, prints and sends to host (if is present) the value NF (-4) or NR (-2). Moreover only with this kind of withdrawing, if a sample falls out from the rotor, the instrument notices it, in fact, after 2 attempts the instrument shows, prints and sends to host (if is present) the value S.M. (-1). NOTE: Every failed attempt, is saved inside the Error Log (see chapter 9.2.7.12) in this way:

1ST NF (INT or EXT) = failed first take (internal or external), not detected continuous blood flow; 2ND NF (INT or EXT) = failed second take (internal or external), not detected continuous blood flow; 1ST NR (INT or EXT) = failed first take (internal or external), sample not detectable; 2ND NR (INT or EXT) = failed second take (internal or external), sample not detectable; WARN. SM = failed first take (only internal), sample missing; SM = failed second take (only internal), sample missing;

NOTE: After 3 consecutive Samples Missing during the analysis (S.M.) the instrument generate the SM01 error like in photo:

If this happen, please perform Roller technical assistance. However is possible press “OK” to continue.


9.1.2 – WASH MENU 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:

9.1.2.1 – INTERNAL WASH

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 (this only with “Debug on”), like in the following example.


If for any reason the washing procedure reports “PHOTOMETER NOT OK” means that the washing cycle has not been executed correctly. Now pressing “OK”; 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.

9.1.2.2 – AUTOMATIC WASH

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.

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 (this only with “Debug on”), like in the following example.




9.1.2.3 – EXTERNAL WASH

Using this option, 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.

Then after inserting the washing tube over the needle, pressing Start the washing procedures is activated. 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 (this only with “Debug on”), like in the following example.




9.1.2.4 –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.



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

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.



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

9.1.2.5 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:

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

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.


9.1.2.6 – 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:


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. 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 (this only with “Debug on”), like in the following example.

If for any reason the washing procedure reports “PHOTOMETER NOT OK” means that the washing cycle has not been executed correctly.


Now pressing “OK”; the instrument will display the following message that suggest to repeat the washing 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. 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.

9.1.2.7 – WASHING ERRORS If for any reason the washing procedure reports “PHOTOMETER NOT OK” means that the washing cycle has 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

9.1.2.8 –WASHINGS PROCEDURE ERRORS (MEANING OF WASHING FLAGS IN DEBUG ON) When configured in DEBUG ON the instrument, during washing procedures (even on latex) shows on the right side of the screen


Four flags which at the beginning of the washing are all at zero; during the washing flags start to change to 1.

• 1° flag means capillary constantly empty • 2° flag means it has been detected the front water arriving (this DOESN’T MEANS DETECTION OF

CONSTANT FLOW), in other word a simple drop of water will change the flag from 0 to 1 • 4° flag means detection of constant flow during 5 seconds for a normal was and 8 second for washing

before latex readings (first water tube before control/calibrators) • 3° flag means detection of capillary empty after a correct detection of water flow, this happens after 4th

flag change from 0 to 1 Referring the table here after, photometer recognizes ADC values as:

• >= 2500 points, means capillary full • < 2500 points means capillary empty

Possibile situations:

Flags Meaning Cause

0000 Capillary not empty Not done First-Up (only on new capillaries or when CPS is new in that case DAC is set at 1023 thus photometer sees ADC >2500 and consequently it is not able to detect the initial emptiness of capillary)

1000 Capillary empty but no water flow detected

- Empty tube - Led o photometer damaged (photometer detect always 0 and understand as capillary empty) - Washing Tank empty (R20PN on automatic wash sequence)

1100 Capillary empty, detected water flow but not enough constancy of flow (5/8 seconds)

- Capillary or needle obstructed - Few water inside washing tubes - Air bubbles aspired due to old stopper or weared out stopper (internal washing) - Air bubbles aspired due to damaged capillary (leakage between funnel and needle or capillary pierced) - Air bubbles aspired due needle not well fixed not fully screwed in or needle loosed (internal and automatic washing) - Air bubbles aspired due external probe not well fixed not fully screwed in or needle loosed (external washing) - Washing Tank empty (R20PN on automatic wash sequence) - Air bubbles stuck inside capillary surface, run a wash with beach top remove them - DAC set at maximum value during calibration washing (>1013 points)

1101 Capillary empty, detected constancy of water flow for 5/8 seconds but capillary still not empty

- Capillary or needle obstructed - Error during emitter calibration procedure, air bubble in front the photometer (extremely rare because since Sw 2.00C a specific control routine has been issued) - Waste tank full which doesn’t allow waste flow to be discharged inside the tank (extremely rare due to sw control routines)

1111 Washing OK (capillary empty) Eventually 3rd flag could remain 0 is a drop of water is still in front the sensor even with capillary conceptually 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.

At the beginning of each Latex Controls session:

Execute one first washing, selecting “Wash”, then load 2 test-tube filled ¾ with distilled water in positions 1 and 2 of the rotor (or in case of external circuit, wash it using 1 tube)



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.


Considering the instrument mounts two independent reading units (CPS), after having pressed “Standard” (from Main Menu) the instrument will first ask to select which circuit will be interested by the latex procedure.

After the selection the procedure is exactly the same for both circuits, the main difference is in the internal circuit instrument does everything automatically after water and latex loading on the rotor. If the external circuit is choosen, the instrument also asks to load the water and latex tubes (like for internal circuit) but then after mixing it will ask to remove one by one the tubes and perform every step by hand. If latex Calibrators are loaded, instrument will require to login as Technical User otherwise it will not allow to continue with the calibration process.


After the selection Internal / External instrument asks to insert tubes following a sequence:

• 1 tube filled ¾ with distilled water • 1 tube “tube 2” , “tube 3” and “tube 4” of Latex control previous identification by EBCR or typing manually the

number printed below the bar code as it is possible to see, latex ID can be inserted by means of:

• External Bar Code Reader (just read the label and insert the tube)

• Typing manually (after having selected “Manual”) and pressing the arrow, then press ok and insert the tube

• Recalling an already memorized triplet (after having selected “Memo”), press OK button and insert the tube

IMPORTANT: AFTER THE SAME TRIPLET’S CODES HAVE BEEN USED 6 TIMES, IN THE EVENT OF A 7th EXTERNAL LOADING PROCEDURE, INSTRUMENT WILL AUTOMATICALLY DISCARD THE TUBE’S CONTENT TO WASTE TANK USING THE INTERNAL NEEDLE

• And the 2 more 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 “Exit” and the instrument will ask to remove the tubes.

• if more than 6 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. After the mixing, if the internal circuit is chosen instrument does the procedure automatically, if external circuit is chosen, instrument will ask to remove one after the other the tubes in sequence.

Probe will be moved down and instrument will aspire water and the latex guiding the User step by step.

Sequence 1) Take out the first tube (water) and close the door, after that tube is inserted over the probe and user press

START

2) Instrument asks to wipe the probe, then to take out the first latex tube, close the door, after that tube is inserted over the probe and user press START, instrument will perform a PRIMING procedure aspiring a small quantity of latex and then will issue 3 beeps, this means the tube MUST BE REMOVED FORM THE PROBE, and the probe wiped out meanwhile the instrument does the priming.

3) After priming instrument asks to wipe the probe, and then to reinsert tube 2 on the probe and pressing START instrument initiate the latex control/calibration aspiring the aliquot of latex, then will issue 3 beeps, this means the tube MUST BE REMOVED FORM THE PROBE and the probe wiped out

The same procedure will be repeated for tube 3 and 4 of latex


4) After latex, take out tube 5 (water) to run first washing after latex, followed by a second wash after latex (tube 6).

5) Finished the washing procedures, instrument will display the expected values and the obtained values

Printout displayed in next page shows a printed report after a Latex Control, as is possible see it is divided in 4 main parts:


Latex Control Printout: Part 1: Barcodes of latex inserted: Latex 2: first code of latex read Latex 3: second code of latex read Latex 4: third code of latex read Part 2: Latex lot number and progressive number of the lot. Values of the DAC before and after washing

Part 3: Washing sequence, here instrument print out the water values of the three tubes (1st before latex and then last 2 after latex) Also report if Photometer is OK or NOT OK Part 4: Operative parameters set to the Reading Unit: Type of reference (EDTA or Citrate ) BoosterY (EDTA or Citrate, in base to the reference chosen) MFact 1 MFact2 Temperature Part 5: In this part the instrument printout the result get after the Control procedure Expected values Measured values.


9.1.3.a – BoosterY adjustment when comparing against Westergreen Method

The BoosterY enables the adjustment and eventual correction of Roller results when compared to those obtained with WESTERGREN in EDTA reference method. The procedure for calibration is :

1. Use fresh blood samples (less than 3 hours from withdrawal) with an hematocrit level higher than 0.37. 2. Evaluate with ROLLER instrument the ESR values, then select at least 30 samples with ESR values in

the range 20÷80 mm/H. 3. On these samples evaluate the ESR WESTERGREN in EDTA and compare the results with those

obtained with the TEST1. If systematic divergence is observed between methods, it is necessary to adjust the BoosterY. How to calculate the new BoosterY:

1. Use the ESR value to obtain its relative integral (associated integral) as listed in table below.

2. Calculate the ratio between the integral of WESTERGREN ESR and the integral of ROLLER instrument ESR.

3. Calculate the MEAN RATIO of all values of ratios obtained in 2.

4. Multiply this MEAN RATIO by the GAIN recorded into ROLLER instrument. The result will be the new

GAIN value giving the best fit of ROLLER instrument results to WESTERGREN 1H in EDTA.

TABLE OF ESR VALUES ASSOCIATED TO RELATIVE INTEGRAL

ESR associated

integral ESR associated integral ESR associated

integral ESR associated integral ESR associated

integral 0 3.4 25 8.5 50 10.9 84 13.3 124 15.7 1 4.1 26 8.6 51 11.0 85 13.4 126 15.8 2 4.6 27 8.7 53 11.1 87 13.5 128 15.9 3 4.9 28 8.8 54 11.2 88 13.6 130 16.0 4 5.2 29 8.9 55 11.3 90 13.7 132 16.1 5 5.5 30 9.0 57 11.4 91 13.8 134 16.2 6 5.7 31 9.1 58 11.5 93 13.9 136 16.3 7 5.9 32 9.2 59 11.6 95 14.0 138 16.4 8 6.1 33 9.3 60 11.7 96 14.1 140 16.5 9 6.3 34 9.4 62 11.8 98 14.2 142 16.6 10 6.5 35 9.5 63 11.9 100 14.3 144 16.7 11 6.6 36 9.6 65 12.0 101 14.4 146 16.8 12 6.8 37 9.7 66 12.1 103 14.5 148 16.9 13 6.9 38 9.8 67 12.2 105 14.6 150 17.0 14 7.1 39 9.9 69 12.3 107 14.7 152 17.1 15 7.2 40 10.0 70 12.4 108 14.8 154 17.2 16 7.3 41 10.1 72 12.5 110 14.9 156 17.3 17 7.5 42 10.2 73 12.6 112 15.0 158 17.4 18 7.6 43 10.3 74 12.7 114 15.1 160 17.5 19 7.8 44 10.4 76 12.8 115 15.2 163 17.6 20 7.9 45 10.5 77 12.9 117 15.3 165 17.7 21 8.0 46 10.5 79 13.0 119 15.4 167 17.8 22 8.1 47 10.6 80 13.1 120 15.5 169 17.9 23 8.3 48 10.7 81 13.1 121 15.5 170 18.0 24 8.4 49 10.8 82 13.2 122 15.6 171 19.0


Example of Roller values underestimated respect to reference WESTERGREN 1H in EDTA:

Sample. N.

ESR Roller

associated integral ESR WG associated

integral Ratio

1 12 6.8 20 7.9 7.9/6.8 = 1.16 2 44 10.4 65 12.0 12.0/10.4 = 1.15 3 80 13.1 130 16.0 16.0/13.1 = 1.22 4 3 4.9 7 5.9 5.9/4.9 = 1.20 5 22 8.1 36 9.6 9.6/8.1 = 1.18 6 49 10.8 76 12.8 12.8/10.8 = 1.18 7 88 13.6 140 16.5 16.5/13.6 = 1.21 8 62 11.8 98 14.2 14.2/11.8 = 1.20 9 55 11.3 78 13.0 13.0/11.3 = 1.15 10 35 9.5 58 11.5 11.5/9.5 = 1.21

The calculated MEAN RATIO is 1.18:

(1.16+1.15+1.22+1.20+1.18+1.18+1.21+1.20+1.15+1.21)/10= 1.18 = Mean Ratio

Example of Roller values overestimated respect to reference WESTERGREN 1H in EDTA:

Samp. N. ESR Roller

associated integral

ESR WG associated integral

Ratio

1 20 7.9 12 6.8 6.8/7.9 = 0.86 2 65 12.0 44 10.4 10.4/12.0 = 0.86 3 130 16.0 80 13.1 13.1/16.0 = 0.81 4 7 5.9 3 4.9 4.9/5.9 = 0.83 5 36 9.6 22 8.1 8.1/9.6 = 0.84 6 76 12.8 49 10.8 10.8/12.8 = 0.84 7 140 16.5 88 13.6 13.6/16.5 = 0.82 8 98 14.2 62 11.8 11.8/14.2 = 0.83 9 78 13.0 55 11.3 11.3/13.0 = 0.87

10 58 11.5 35 9.5 9.5/11.5 = 0.82

The calculated MEAN RATIO is 0.83:

(0.86+0.86+0.81+0.83+0.84+0.84+0.82+0.83+0.87+0.82)/10= 0.83 = Mean Ratio.

Example: 1.15 = previous recorded BoosterY 1.18 = MEAN RATIO The new adjusted BoosterY is: 1.15x1.18 = 1.357

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 “Back” before starting mixing, 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

ROLLER 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, in case of Roller instrument having two independent reading units has also two independent statistical databases so before getting access to the statistics options it is necessary select the circuit of interest:

After that, instrument displays the Statistical Main Menu: The instrument collects data from:

• 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.

How can see from the graph below, the instrument shows the trend of the last 30 days, from which is easy to identify any possible drift or abnormal values.

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 or every time Photometer NOK is issued 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.


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



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.


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 to 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 References to the type of data: Daily average, Cumulative average Lower and Upper acceptability limits 5 15 25 limits: from 2 to 30 |-----|-----|-----|-----|-----| 8.88 ● black dot is the cumulative average 4.11 o white dot is the average of day 1 6.69 ● cumulative average (day 1 + day 2) 8.67 o white dot is the average of day 2 7.14 ● cumulative average (day 1 + day 2 + day 3) 8.82 o white dot is the average of day 3 Data belonging today’s analysis Total number of days analysis In the lower part of the plot, are reported the values of daily and progressive average and SD: 7,58 is the last cumulative value, and has to fall down into the calculate

range [min – max]; STD o 2.85 corresponds to the daily mean of the SD; STD ● 0.83 corresponds to the cumulative mean of the SD; CV% ● 8,63 corresponds to the cumulative mean of the CV%.


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)

Number of samples, analyzed in the day, that falls inside the global range (2-120)

References to the type of data: Daily average, Cumulative average Lower and Upper acceptability limits 5 15 25 |-----|-----|-----|-----|-----| 8.88 ● black dot is the cumulative average 4.11 o white dot is the average of day 1 6.69 ● cumulative average (day 1 + day 2) 8.67 o white dot is the average of day 2 7.14 ● cumulative average (day 1 + day 2 + day 3) 11.48 o white dot is the average of day 3 Data belonging today’s analysis Total number of days analysis In the lower part of the plot, are reported the values of daily and progressive average and SD: STD o 4.31 corresponds to the daily mean of the SD; STD ● 1.34 corresponds to the cumulative mean of the SD; CV% ● 10,37 corresponds to the cumulative mean of the CV%.


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 2-120 is 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 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. Data belonging today’s analysis Total number of days analysis

At the end of the graph, the Standard Deviations of cumulative average and daily average are printed: 7,58 is the last cumulative value, and has to fall down into the calculate range

[min - max]; [min = mean of all cumulative values – 3 x cumulative STD ●] [max = mean of all cumulative values + 3 x cumulative STD ●]

STD o 2.85 corresponds to the daily mean of the SD; STD ● 0.83 corresponds to the cumulative mean of the SD; CV% ● 8,63 corresponds to the cumulative mean of the CV%.

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 (cumulative STD x 3 0.83 x 3 = 2.49), 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 mean of all cumulative values, except the last one (daily value), is (7.14), and so the lower limit it will be (7.14 – 2.49 = 4,65), and the upper limit it will be (7.14 + 2.49 = 9,63). In this case, the daily cumulative value (7.58) 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 cumulative SD raises.


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 (2-2)” 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 Statistical data: Average and SD of the data analyzed. The mean and SD values refers to the data in the interval 2-120. As it can be seen, the instrument generates a statistical report in which the ESR results are redistributes in subintervals (of the normal interval 2-120) For each subinterval is available: limits of the interval percentage of samples in each interval number of samples analyzed that belong to each subinterval

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 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


9.1.6.7 – “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 (3-2)” 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 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

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 9 mm/h), one intermediate level (around 19 mm/h) and a high level (around 65 mm/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


Execute one first washing, selecting “Wash”, then option “Internal / External” (depending the circuit to be controlled), load 2 test-tube filled ¾ with distilled water in positions 1 and 2 of the rotor

Execute a second washing selecting “Wash” then option “Internal / External” (depending the circuit to be controlled), 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.


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 /

External” (depending the circuit to be washed), load 2 test-tube filled ¾ with distilled water in positions 1 and 2 of the rotor; if external withdrawing tip has been used just follow the instructions shown on 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:

-20 -10 1 +10 +20 DEV % |------------|------------|-----------|-----------| 0 | | ● | | 0 | | o | | 0 | | ● | | 8 | | | o | | 1 | | |● | | 1 | | |o | | -2 | | ● | | | -4 | | o | | | -2 | | ● | | | 4 | | | o | | Sens ● AV 1,22 - STD: 0,47 Sens o AV 2,55 - STD: 0,48

In order to better understand the meaning of the results printed out, imagine a series of three controls with values of 9, 19 and 65 mm/h (values of reference). Executing the control of the analyzer, if the values will be identical (9, 19 and 65 that is the ideal case), there won't be a shift (y=1.00*x) and the dots symbol will printed exactly on the column 1, as on the first line on the aside graph. On the contrary, if the results are for example 10, 21 and 70 mm/h, the shift would be +8,00% (y=1.08*x) and the dots will be positioned between column 1 and column +10%, like the fourth white dot in the graph aside. At the bottom are printed out the Average of DEV% values (AV) and the Standard Deviation (STD).


Results obtained during the latex calibration procedure are stored by the instrument; it is therefore possible to print out a report pressing the key “Datalogger”. With this option it is possible to visualize precise information about all calibrations done, like the LOT and the KIT of the triplet, the date of withdrawal, old and new Model Fact1 and Model Fact 2, the type of withdrawal and if the flag priming latex is on or off

Printout explanation:

LOT number, KIT number, date of withdrawal Mfact1 old -> new (value of Model Fact1 pre and post calibration) Mfact2 old -> new (value of Model Fact1 pre and post calibration) DAC1 old -> new (value of DAC1 pre and post calibration) DAC2 old -> new (value of DAC2 pre and post calibration) DACSTOP old -> new (value of DACSTOP pre and post calibration) Ext circuit: 0 or 1 (0 = calibration done with internal withdrawal) (1 = calibration done with external withdrawal) Prim latex: 0 or 1 (0 = calibration done with priming latex disable) (1 = calibration done with priming latex enable) Code: 1 or 2 or 3 (1 = ID inserted manually) (2 = ID inserted with “Memo” button) (3 = ID inserted with External Barcode Reader)


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”. Pressing “Q.C.”, (from Main Menu) the instrument, in case of Roller instrument having two independent reading units has also two independent statistical databases so before getting access to the statistics options it is necessary select the circuit of interest:


After that, instrument displays the Statistical Main Menu 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. For the 2 latex database, “Print (4-1) and “Datalogger”, when pressed “Res.” also Datalogger database will be erased. 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

In case of Roller instrument having two independent reading units, before accessing the CPS parameters is necessary to select the circuit of interest:

After having done the selection, the following menus are identical; they reports the configuration for the internal or external circuit.

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 TYPE OF REFERENCE (CHOOSE BOOSTERY TYPE) (Technical password required) As stated before, to have the possibility to modify this parameter it is necessary to be logged 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 (1990 for technical level). This function allows to choose the type of reference that the instrument uses. Be careful that, once the reference was choose, is recommended to not changing it anymore. After pressed “SET” to choose the type of reference, the instrument asks to confirm, so if is pressed “NO” or “Back” button the instrument comes back to CPS menu, otherwise if is pressed “YES” the instrument allows to choose the reference:

In fact is possible to choose the reference just pressing “EDTA” (for EDTA BoosterY) or “Sodium Citrate” (for Sodium Citrate BoosterY) and finally press “OK” :

Then the instrument will display again the previous image with the current reference.


9.2.1.1.b – MODIFY BOOSTERY’s VALUE (Technical password required) As stated before, to have the possibility to modify these parameters it is necessary to be logged 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 (1990 for technical level). For modify BoosterY EDTA, press “SET” to modify the value according to local Lab’s references or Westergren references; on the other hand pressing “AUTO”, BoosterY’s value will be automatically calculated and configures as the average of the two ModelFact’s values.

To modify just type the desired value

then press the “left arrow” to confirm or “Back” to exit without change anything, the instrument will display again the previous image with the BoosterY’s new value. Pressing “OK” is possible to go back to CPS Menu. For modify BoosterY Citrate, press “SET” to modify the value according to local Lab’s references or Westergren references:


then press the “left arrow” to confirm or “Back” to exit without change anything, the instrument will display again the previous image with the BoosterY’s new value. Pressing “OK” is possible to go back to CPS Menu.


9.2.1.1.c – MODIFY WHOLE PARAMETRES’ VALUES

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 THESE PARAMETERS CAN AFFECT INSTRUMENT’S PERFORMANCES AND CAN CAUSE AN INCORRECT BLOOD ANALYSIS RESULTS.

TECHNICIANS THAT MODIFY THESE 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.d – MODIFY MODEL FACT’s VALUES (Technical password required)

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.


then press the “left arrow” to confirm or “Back” to exit without change anything, the instrument will display again the previous image with the new Model Fact value. Pressing “OK” is possible to go back to CPS Menu.

9.2.1.1.e – MODIFY Offset Sensors VALUES (Technical password required)

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 “Back” to exit without change anything, the instrument will display again the previous image with the new Offset value. Pressing “OK” is possible to go back to CPS Menu.


9.2.1.1.f – MODIFY THERMOSTAT reference value (Technical password required)

To modify thermostat sensor reference value press “SET” to access configuration page, where is possible so set manually the desired temperature. As explained before, numbers are typed using the keyboard.


then press the “left arrow” to confirm or “Back” to exit without change anything, the instrument will display again the previous image with the new Model Fact value. Pressing “OK” is possible to go back to CPS Menu.

9.2.1.2 – CPS Correctors Parameters (Available only if a Multiparametric card is used) (Technical password required) This function is conceptually similar to BoosterY; the main difference is it allows to change the “gain” of the other supplementary parameters the instrument is able to measure. The supplementary parameters are enabled by means of a “Multiparametric Card” loaded on the instrument. Field Engineers logged as Technical Service User can have access to this page and check the configuration of the gain of each one of the parameters. By default all the values are set at 1.0000 and MUST REMAIN AT 1.

To change the value of a parameter, press “SET” to access configuration page, where is possible so set manually the desired value. Numbers are typed using the keyboard; 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 new Model Fact value. Pressing “Back” is possible to go back to CPS Menu.


9.2.1.3 – 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 latex 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 reference value of 3800 (printed out during washing procedure). DAC reference number goes from 0 to 1023; normal working range goes from 500 to 800,.

ADC: 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 normal value should be around 2000 - 2200

To modify DAC’s values proceed as described for the others examples, for each sensor appears a keyboard in which the technician can set the desired value. Values goes from 0 to 1023.

9.2.1.4 – 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 2 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” • The desired number of Cycles Centrifugations (for pediatric mode): pressing “set” the instrument will

display a keyboard where the operator can type the desired number of cycles (from 2 up to 100), then pressing the “left arrow” confirm the new value.

• by default the instrument is set up at medium speed, 140 cycles and 30 centrifugation cycles. Finally the operator can check practically the rotor speed, 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

This function’s accessibility is linked to a password level. 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)


As stated before, to have the possibility to modify these parameters it is necessary to be logged as “user level” 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.

then press the “left arrow” to confirm or “Back” to exit without change anything, the instrument will display 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 of both reading Units

In the Flag List are printed out all the operational parameters of the instrument. UNIT INTERFACE

Date and time of the software compilation Instrument serial number Debug (ON or OFF) (Only Technical Service) Threshold level for Maintenance intervention requesting. (Only Technical Service) reference value: 30000 Maintenance counter, counts the number of analyses Threshold (in minutes) for automatic washing. (Only Technical Service) reference value 60 patient ID and ESR results printing on real time (ON or OFF) IDs and ESR results on double height printing (ON or OFF) Specify if 1 or 2 CPS are installed on the instrument (Only Technical Service) Specify if the latex priming is enabled or not (Only Technical Service) by default is enabled Specify if pediatric samples are enabled or not (Only Technical Service) Test availability for the ESR and other parameters analysis ESR and other parameters counter of executed test Smart warning (Only Technical Service) reference value 1000 Smart personalization (distributor name)

MOTOR BOARD Motor Board Software version. Date and time of the Motor Board software compilation. Number of mixing revolutions, from 2 to 1000. Mixing speed, 1=60 RPM (default), 2=32 RPM and 3=26 RPM Withdrawal volume of blood in automatic sampling, reference value 175 Withdrawal volume of blood in manual sampling, reference value 100 Upward steps done by syringe in automatic sampling, reference value 3450 Upward steps done by syringe in washing procedure, reference value 4500 Tube offset, (used to align rotor in front of loading sensors), reference value 0 Syr Fast, define if the syringe moves up-down slow or fast reference value OFF Centrifugation cycles, number of cycles for pediatric samples, from 2 to 100


CPS BOARD (INTERNAL) Analogical Board Software version. Date and time of the CPS Board software compilation. Instrument BoosterY reference (EDTA or Sodium Citrate) (Only Technical Service) Instrument Gain (BY EDTA or CITRATE) in base to the reference chosen (Only Technical Service) Latex gain factor Sensor 1, values accepted between 0,6000 to 1,6000 (Only Technical Service) Latex gain factor Sensor 2, values accepted between 0,6000 to 1,6000 (Only Technical Service) Compensator factor to instrument calibration for Sensor 1 (Only Technical Service) Compensator factor to instrument calibration for Sensor 2 (Only Technical Service) Reading Unit temperature, values accepted between 20 to 40 (Only Technical Service) Instrument switching off counter without washing procedure Value of washing water read and memorized for Sensor 1 Value of washing water read and memorized for Sensor 2 Value of washing water read and memorized for Stop Sensor Analogical Reference for Sensor 1 (Only Technical Service) Analogical Reference for Sensor 2 (Only Technical Service) Analogical Reference for Stop Sensor (Only Technical Service) CPS BOARD (EXTERNAL) Analogical Board Software version. Date and time of the CPS Board software compilation. Instrument BoosterY reference (EDTA or Sodium Citrate) (Only Technical Service) Instrument Gain (BY EDTA or CITRATE) in base to the reference chosen (Only Technical Service) Latex gain factor Sensor 1, values accepted between 0,6000 to 1,6000 (Only Technical Service) Latex gain factor Sensor 2, values accepted between 0,6000 to 1,6000 (Only Technical Service) Compensator factor to instrument calibration for Sensor 1 (Only Technical Service) Compensator factor to instrument calibration for Sensor 2 (Only Technical Service) Reading Unit temperature, values accepted between 20 to 40 (Only Technical Service) Instrument switching off counter without washing procedure Value of washing water read and memorized for Sensor 1 Value of washing water read and memorized for Sensor 2 Value of washing water read and memorized for Stop Sensor Analogical Reference for Sensor 1 (Only Technical Service) Analogical Reference for Sensor 2 (Only Technical Service) Analogical Reference for Stop Sensor (Only Technical Service) COMMUNICATION BOARD Communication Board Software version. Date and time of the Communication Board software compilation. Serial communication protocol Instrument number, if there is more than one instrument in series. 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 Max number of attempts if the host don’t receive the ACK The instrument will/will not do the analysis if TIMEOUT event happens (Only Technical Service)


9.2.5 – SETTINGS MENU This function’s accessibility is linked to a password level. 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 X means the release of software. The release is expressed by a letter from A up to Z Interface Unit Board Software Version Display Software Version Motor Board Software Version Analogical Board Software Version Analogical Board Software Version (if is a Roller 20PN) 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.

Roller SW RELEASE: R10-03.00X


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; to access the function press “Language” the instrument will display: Available languages are:

English Italian Spanish French Russian

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 As stated before, to have the possibility to modify these parameters it is necessary to be logged as “user level” otherwise the instrument will not allow to access the function. 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 change date and time set up of the instrument: Now, pressing “Setup” in the main menu and 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

then press the “left arrow” to confirm or “Clear” to exit without change anything, the instrument will display 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:

Buttons for changing page, from page 1 to page 2 (>>>>) and vice versa (<<<<). 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. XXXX” (in the Setup Menu), the instrument will display a keyboard allowing to type the desired serial number: then press the “left arrow” to confirm or “Clear” to exit without change anything, the instrument will display again the previous image. Pressing “Back” is possible to go back to MAIN SCREEN.

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.

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 5 typologies of Roller 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; • Roller 20 WN: the same as Roller 20 PN, but only with the internal withdraw. • Roller 20 MC: instrument only with manual external withdrawal without mixing (available soon, so don’t

use or select this type of Roller)

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 “OK” the instrument will display again the Setting Menu screen

DEBUG


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:

then press the “left arrow” to confirm or “Clear” to exit without change anything, the instrument will display again the previous image. Pressing “Back” is possible to go back to MAIN SCREEN.


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. Pressing “Back” the instrument will display again the Setting Menu screen without have reset the instrument.

9.2.7.7 – PRINT PARAMETERS This function, if activated, allows to print or not the other 5 parameters. Press “Print Par.” in order to access the print function, the instrument will display: Now for every single parameter you can choose if print it (ON) or not (OFF), but if only a multi parameters card has been loaded. In fact, if there are no credits for all the 5 parameters, the instrument don't print them, even though the print selection is ON. For the ESR, the instrument always print it, independently if print selection is ON or OFF, of course If there are ESR credits.


9.2.7.8 – 2 CPS

This function, allows to configure the instrument. Pressing “2 CPS” is possible identify if the instrument works with:

• 2 CPS (set by default) refers to instrument without rotating valve and using two independent reading units and hydraulic circuits

• 1 CPS, this must be set in case the instrument is still mounting the Rotating Valve

9.2.7.9 – LATEX PRIMING This function, if enabled (by default it is) configure the instrument to perform a priming (the same concept used for blood) also for latex. After mixing latex, instrument, before doing latex readings, makes a priming of the capillary using the most clear latex in order to prepare the capillary.

After the priming, instrument performs the latex readings as normally done.

The function is applicable to both the internal and external circuits.

9.2.7.10 – SYRINGE FAST This function, if enabled (by default it is not) configure the instrument to move the internal syringe in a fast mode, this is piercing of tubes loaded on the rotor is done quickly. The main advantage is the movement is done quickly and this increases a bit the performance of instrument.

If the syringe fast is enabled, it is important to be sure the shaft of the stepper motor is very well lubricated, otherwise a minimal friction could cause a stall of the syringe.


9.2.7.11 – PEDIATRIC SAMPLES This function, if enabled (by default it is not) configure the instrument to permit it to analyse also the pediatric samples. In this mode, instrument rotor mix the sample with a special function, called centrifugation, that is much powerful and fast than normal mixing. But remember this type of mixing must be used only with pediatric samples, not with normal samples!

9.2.7.12 – ERROR LOG This function, if activated, allows to see and print the mechanical and analytical errors. Press “Errors Log.” in order to access the errors log, the instrument will display: The screen show all the errors, and relative counters, only if the single error occurred in the instrument, otherwise this is invisible until it occurs. You can Print the Errors Log, pressing “Print” button, and also delete them pressing “Delete” and when the instrument ask you to confirm, if you press “Yes” the function erases all the data, instead if you press “No” the instrument come back to Setup menu. Example of printout errors log:


9.2.8 – LOG IN-OUT As stated before, the user will be required to type in a password to rise up from the 2nd to the 3rd level of the instrument’s setup, otherwise the instrument will not allow to access the whole functions. To login is necessary to access (from Main Screen) to Setup


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 1. 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

2 “LOGIN – USER LEVEL”: 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 (base level).

3 “LOGIN – TECH LEVEL”: 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 otherwise the instrument will not allow to access the function. 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 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 “tech level” otherwise the instrument will not allow to access the function. To login is necessary to access (from Main Screen) to Setup


pressing “LOGIN” the instrument will display a keyboard to type the password, type the password:1990 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”.


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 09. 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.

pressing “Back” it is possible to go back to MAIN SCREEN.


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;

pressing “Back” it is possible to go back to MAIN SCREEN. 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 analyse 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 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.

9.4.1.6 – 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 analyse 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), the instrument will send results to host computer.

• If “Send 6 par” is disabled (default), the instrument sends only ESR result 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 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.

NOTE: at the moment it is not suggest to activate 6 parameters transmission to host computer because Host protocol is not designed to receive all 6 parameters, only ESR. 9.4.1.9 – Curve Parameters Transmission (under development).

The function is used to send additional results to host computer. Roller family instruments are able to send the parameters of the blood curve to host computer.

• If “Curve Par” is disabled (default), the instrument sends only ESR result to host computer.

• If “Curve Parr” is enabled, the instrument sends also the blood curve parameters.

To access the function press “Curve Par” 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.

NOTE: at the moment it is not suggest to activate curve parameters transmission to host computer because Host protocol is not designed to receive them.


9.4.1.10 – 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.

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

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.


9.4.1.10.a – DAT 8 INTERFACE (NO QUERY)

Pressing “DAT 8 button, the instrument will highlight and activate this option as communication protocol

DAT8 transmission and its examination:

Field name

Symbol Hex

value Length

Description Note1: Checksum value is the result of Exclusive OR (XOR) of all characters of the message, excluded STX, ETX and Checksum. If the Checksum value calculated by the analyzer is 03 (corresponding to ETX), or 02 (corresponding to STX), or 00 (corresponding to NULL), the value will be automatically replaced with 7F hex value. Software House must adopt the same procedure when calculating checksum of the strings received from the analyzer.

Note2: Bayer field not used, in this case show s the progressive analysis cycle

STX ☻ 02 1 char

Start transmission ‘R’ 52 1 char R states for result message Workstation Number 2 char Is the number identifying the instrument if more than

one is connected to Host computer Patient ID Number 8 char

Patient identification Wheel no. 2 char Indicate the progressive number of analysis made Position 2 char Indicate the sample position inside the wheel Bayer (Note 2) 2 char

See note 2 Result 4 char ESR result Checksum (Note 1) 1 char See note 1

ETX ♥ 03 1 char End transmission

Total length 24 char

PROTOCOL Query DESCRIPTION R message structure SYMBOLS NOTES

DAT8 No

Used to read the maximum patient identity length of 8 characters by an external bar code reader (EBCR) It can be also used to insert patient IDs manually.

STX 1 byte R 1 byte Not used 2 byte Identification no 8 byte Not used 6 byte ESR result 4 byte Checksum 1 byte ETX 1 byte TOTAL = 24 byte

☻

♥

Checksum note Checksum value is the result of Exclusive OR (XOR) of all characters of the message, excluded STX, ETX and Checksum. If the Checksum value calculated by the analyzer is 03 (corresponding to ETX), or 02 (corresponding to STX), or 00 (corresponding to NULL), the value will be automatically replaced with 7F hex value. Software House must adopt the same procedure when calculating checksum of the strings received from the analyzer.


9.4.1.10.b – DAT 15 INTERFACE (NO QUERY)

Pressing “DAT 15” button, the instrument will highlight and activate this option as communication protocol

DAT15 transmission and its examination:

Field name

Symbol Hex

value Length


Note2:see previous table

STX ☻ 02 1 char

Start transmission ‘R’ 52 1 char R states for result message

Workstation Number 2 char Is the number identifying the instrument if more than


Patient identification Rack no. 2 char Indicate the progressive number of analysis made Position 2 char Indicate the sample position inside the wheel Bayer (Note 2) 2 char

See note 2 Result 4 char ESR result

Checksum (Note 1) 1 char See note 1




DAT15 No

Used to read the maximum patient identity length of 15 characters by an external bar code reader (EBCR).

STX 1 byte R 1 byte Workstation number 2 byte Identification n 15 byte Rack number 2 byte Position 2 byte Cycle/Bayer 2 byte ESR result 4 byte Checksum 1 byte ETX 1 byte TOTAL = 31 byte

☻

♥

Note1: Checksum value is the result of Exclusive OR (XOR) of all characters of the message, excluded STX, ETX and Checksum. If the Checksum value calculated by the analyzer is 03 (corresponding to ETX), or 02 (corresponding to STX), or 00 (corresponding to NULL), the value will be automatically replaced with 7F hex value. Software House must adopt the same procedure when calculating checksum of the strings received from the analyzer.

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.


9.4.1.10.c – BCI INTERFACE (QUERY)

Pressing “BCI” button, the instrument will highlight and activate this option as communication protocol

BCI transmission and its examination:

Field name

Symbol Hex

value Length


Note2:see previous table

STX ☻ 02 1 char

Start transmission ‘R’ 52 1 char R states for result message

Workstation Number 2 char Is the number identifying the instrument if more than


Patient identification Rack no. 2 char Indicate the progressive number of analysis made Position 2 char Indicate the sample position inside the wheel Bayer (Note 2) 2 char

See note 2 Result 4 char ESR result

Checksum (Note 1) 1 char See note 1



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 9.4.1.10.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. 9.4.1.11 – PROTOCOL INTERFACE EXPLICATION


BCI Yes

Used to read the maximum patient identity length of 15 characters by an external bar code reader (EBCR). The instrument enables Query protocol to interrogate the host if a specific sample needs to be analyzed or not.

STX 1 byte R 1 byte Workstation number 2 byte Identification n 15 byte Rack number 2 byte Position 2 byte Cycle/Bayer 2 byte ESR result 4 byte Checksum 1 byte ETX 1 byte TOTAL = 31 byte

☻

♥

Note1: Checksum value is the result of Exclusive OR (XOR) of all characters of the message, excluded STX, ETX and Checksum. If the Checksum value calculated by the analyzer is 03 (corresponding to ETX), or 02 (corresponding to STX), or 00 (corresponding to NULL), the value will be automatically replaced with 7F hex value. Software House must adopt the same procedure when calculating checksum of the strings received from the analyzer.

Note2: If Bayer is 0, the field deals

with the number of Cycle otherwise if Bayer is 1, the field will contain '01' (hex 30 and 31) to maintain the Bayer protocol compatibility.


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

Field name Hex value Length Field name Hex

value Length Field name Hex value

Length

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 number 2 char Workstation

Number 2 char Workstation Number 2 char

Patient ID number 15 char Patient ID

Number 15 char Patient ID Number 15 char

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

Total length 25 char Total length 25 char Checksum (Note 1) 1 char

ETX (Note 2) 03 1 char

Total length 31 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 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 checked. The wheel will rotate to one position to allow the operator to insert the sample tube, if “T” message has the result field 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 the 10th (Roller 10) or the 20th (Roller 20) before starting the analysis.

3. After measuring (20 seconds about), Roller 10 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 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 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.

<STX>Q01123456789 0000a<ETX>

<STX>T01123456789 0001e<ETX>

<STX>T01123456789 0000d<ETX>

<STX>R01123456789 0103050012f <ETX>

<STX>R01123456789 010305-004l <ETX>

Hexadecimal code 0x06


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 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]

[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. 9.4.1.12 – LATEX PROTOCOL INTERFACE EXPLICATION

<STX>R010307920106 0106030012f

Hexadecimal code 0x21


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 Field name Hex

value Length Description

STX (Note 2) 02 1 char ‘R’ 52 1 char Means the instrument is sending a Result

Workstation Number 2 char Identifies the workstation if more instrument are connected, normally is 01

LATEX0 XYZ 9 char Is the identification of the latex and the Lot to which they belong

Field 1 1 char Can be 1, 2 or 3 and identifies level 1, 2 and 3 of 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 Total length 31 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>R01LATEX08451009 0101010002<0x19><0x3> <0x2>R01LATEX08452019 0102010034<0x1c><0x3> <0x2>R01LATEX08453065 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 NO HOST is configured, the instrument will not communicate with Host Computer

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>


9.5 – TECH MENU (Technical password required)

Under this menu resides all the functions and options related with the TECHNICAL CONFIGURATION of Roller 20. To modify the whole parameters’ values is MANDATORY to login using the Technical Service password. 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. To login is necessary to access (from Main Screen) to Setup


pressing “LOGIN” the instrument will display a keyboard to type the password, type the password:1990 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”. Now on MAIN MENU will be indicated the “LOGIN: tech level”. Then pressing “Tech” from main menu, the instrument shows the following options


9.5.1 – PUMP CONFIGURATION

This function, if activated, allow to setup the amount of blood to be withdrew from the sample tube: • Internal 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.

• External taking:

This option is for 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 of step is also displayed. Pressing “for” or “rev” is possible (having previously activated the manual syringe and being ready to insert a sample tube when requested) simulate the withdrawal even 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.

• Fast:

This option is available on all models; pressing “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: This option is available on all models; pressing “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 Roller 20 PN and 20 LC; 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:

This option is available on all models; pressing “SET” will be displayed a digital keyboard where 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 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. “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:

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.

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 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 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. Pressing “Back” the instrument will display again the Main Menu screen.


9.5.3 – SYRINGE MAN

This function, if activated, is used to check the movement of the external needle in order to allow the instrument analyze paediatric sample or sample tubes with plastic cap. Pressing “Out” the needle moves to the withdrawing position. In this way is possible to check stop sensor operativity. Pressing “Home” 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.

Pressing “Back” the instrument will display again the Main Menu screen.


9.5.4 – CARRIAGE ALIGNMENT (AVAILABLE ONLY ON ROLLER 20 PN/LC 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 (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, the instrument ask you to confirm, then if you press “YES” button, 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. If you press “NO” button, never change and the instrument come to the menu. 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 inter displacement 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 tube from position. Pressing “Take tube from 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 “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

Insert tube in position .: Pressing “Insert position” allow rotor to be moved in front the loading door. Stopping position belong to the corresponding sample tube selected. To select which tube must be placed just type the “number” 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


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 can easily exit from the sensor reading path. 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.

GOOD

GOOD

WRONG


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 “left 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:


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 To login is necessary to access (from Main Screen) to Setup


pressing “LOGIN” the instrument will display a keyboard to type the password, type the password: 1990 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 access CPS Menu pressing “Setup” from the MAIN SCREEN, the instrument shows the following options


Having the instrument two independent CPS, before doing First-Up it is necessary to select to which one of the two circuits the procedure will be done.

then pressing “First Up” the instrument will ask to load a tube filled ¾ with distillate water into position 1 of the rotor for the internal circuit or a tube inserted in the external probe for the external one. 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.


11.0 – LATEX CALIBRATION

Run the calibration procedure only in DEBUG On Mode Considering the instrument mounts two independent reading units (CPS), after having pressed “Standard” (from Main Menu) the instrument will first ask to select which circuit will be interested by the latex procedure.

After the selection the procedure is exactly the same for both circuits, the main difference is in the internal circuit instrument does everything automatically after water and latex loading on the rotor. If the external circuit is chosen, the instrument also asks to load the water and latex tubes (like for internal circuit) but then after mixing it will ask to remove one by one the tubes and perform every step by hand. To run Calibrators, instrument will require to login as Technical User otherwise it will not allow to continue with the calibration process. To login is necessary to access (from Main Screen) to Setup



pressing “LOGIN” the instrument will display a keyboard to type the password, type the password: 1990 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”. After the selection Internal / External instrument asks to insert tubes following a sequence:

• 1 tube filled ¾ with distilled water • 1 tube “tube 2” , “tube 3” and “tube 4” of Latex control previous identification by EBCR or typing manually the

number printed below the bar code as it is possible to see, latex ID can be inserted by means of:

• External Bar Code Reader (just read the label and insert the tube)

• Typing manually (after having selected “Manual”), pressing the arrow and insert the tube

• Recalling an already memorized triplet (after having selected “Memo”), press OK and insert the tube

IMPORTANT: AFTER THE SAME TRIPLET’S CODES HAVE BEEN USED 6 TIMES, IN THE EVENT OF A 7th EXTERNAL LOADING PROCEDURE, INSTRUMENT WILL AUTOMATICALLY DISCARD THE TUBE’S CONTENT TO WASTE TANK USING THE INTERNAL NEEDLE

• And the 2 more 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 “Exit” and the instrument will ask to remove the tubes.


• if more than 6 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. After the mixing, if the internal circuit is chosen instrument does the procedure automatically, if external circuit is chosen, instrument will ask to remove one after the other the tubes in sequence.

Probe will be moved down and instrument will aspire water and the latex guiding the User step by step.

Sequence 1) Take out the first tube (water) and close the door, after that tube is inserted over the probe and user press

START

2) Instrument asks to wipe the probe, then to take out the first latex tube, close the door, after that tube is inserted over the probe and user press START, instrument will perform a PRIMING procedure aspiring a small quantity of latex and then will issue 3 beeps, this means the tube MUST BE REMOVED FORM THE PROBE, and the probe wiped out meanwhile the instrument does the priming.

3) After priming instrument asks to wipe the probe, and then to reinsert tube 2 on the probe and pressing START instrument initiate the latex control/calibration aspiring the aliquot of latex, then will issue 3 beeps, this means the tube MUST BE REMOVED FORM THE PROBE and the probe wiped out


The same procedure will be repeated for tube 3 and 4 of latex 4) After latex, take out tube 5 (water) to run first washing after latex, followed by a second wash after latex

(tube 6).

5) Finished the washing procedures, instrument will display (if in debug on mode) the photometrical values read by the CPS (this is useful especially in case of latex values out of expected working ranges)

6) Next is the expected values and read values


Pressing “SET”, instrument automatically adjust the ModelFact of each one of the two sensors and displays the new values after gains adjustments. Instead pressing “Exit” the instrument keeps the original (old) ModelFact of both sensors. IT IS IMPORTANT TO REPEAT AT LEAST TWO MORE TIMES THE CALIBRATION PROCEDURE TO CONFIRM THE NEW GAINS ARE EFFECTIVELY BEEN SET AT THE APPROPRIATE VALUE.

Printout displayed in next page shows a printed report after a Latex Calibration, as is possible see it is divided in 6 main parts: Latex Calibration Printout

Part 1: Barcodes of latex inserted: Latex 2: first code of latex read Latex 3: second code of latex read Latex 4: third code of latex read Part 2: Latex lot number and progressive number of the lot. Values of the DAC before and after washing

Part 3: Washing sequence, here instrument print out the water values of the three tubes (1st before latex and then last 2 after latex) Also report if Photometer is OK or NOT OK Part 4: Operative parameters set to the Reading Unit: Type of reference (EDTA or Citrate ) BoosterY (EDTA or Citrate, in base to the reference chosen) MFact 1 before calibration MFact2 before calibration Temperature


Part 5: Photometrical values read by sensors.

Part 6: Corresponding values read using gains MF1 and MF2

ModelFac1 AFTER CALIBRATION ModelFac2 AFTER CALIBRATION

Part 7: Values obtained after having pressed SET adjustment.

Working with the latex reference (MFact) BY EDTA should be set to at the average value of the 2 ModelFact. This can be done from Setup (CPS), see chapter 9.2.1.1.a 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 BY EDTA value should be adjusted calculating a correlation between Roller and Westergren or using a “quick” method explained in the next chapter.

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 because Latex Control procedure is based on the MFact.

To calculate the new BoosterY’s value please refer to chapter 9.1.3.a

If necessary to modify Y’s EDTA value proceed as follows:

Access again CPS menu

Having the instrument two independent CPS, before doing the BY EDTA adjustment it is necessary to select to which one of the two circuits the procedure will be done.


Pressing “Parameters” and “SET” the instrument allow to modify BY’s EDTA value according to local Lab’s references or Westergren references; on the other hand pressing “AUTO”, BY’s EDTA value will be automatically calculated and configures as the average of the two ModelFact’s values.


then press the “left arrow” to confirm or “Clear” to exit without change anything, the instrument will display again the previous image with the BY’s EDTA 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.


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 pushing it till you ear the “click” of the latch .

Localize the piston group(displayed in the photo):


Unscrew the fixing screw

Unscrew the upper side of the piston (as shown in the photo. This procedure allow to access the piston’s internal side

Pull the CBC adapter (piston) that will tilt to 45°.


Take the new needle, remove the transparent cap that protects the needle thread. The ord. code for the new needle is SI 1955077

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.

Insert the green tool (supplied) inside the piston, unscrew completely the needle and remove it. This operation has to be done in safety. Discard the replaced needle.

Apply again the piston’s tip, screw in to the right side (as shown in the photo.


Note: After needle replacement is suggest to do a washing routine

Push back the piston and screw the fixing screw


13.0 – ROLLER Start-Up Sequence and Boards Description

Here is explained by means of a flowchart the start-up sequence, to see the error messages.




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.

Motor Board

Unit

Interface Board

Analogical Board

(Reading Unit)

Display and Touch screen

Communication Board

Rotor Motor

Peristaltic Pump

Printer Smart Card

Syringe Motor

Syringe and Carriage Hub

Board

Piston Assembly

Rotor, Pump and Peripherals

sensor Hub Board

UI Board and Display


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. 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.

UI Board turned up side down

Printer Port

Signals to/from other boards

Smart Card input port

Dedicated Processor

Touch screen

Syringe Group

Syringe Motor

Carriage Sensors Board

Carriage Motor

Syringe Sensor Board

Piston Sensor (located

inside the piston)


13.2 – Syringe Group Replacement and/or carriage realignment 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 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”. Now on MAIN MENU will be indicated the “LOGIN: tech level”. Then pressing “Tech” from main menu, the 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 ALIGNMENT

GOOD ALIGNMENT

WRONG 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.

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:

Home: This option moves carriage under the washing station that is considered also as “Home Position”. Rotor 1: This option moves carriage under the “left rotor”.

Rotor 2: This option moves carriage under the “right rotor”.

Washing Station

Water tubes to Washing Station

Carriage

Carriage Stepper Motor


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.



pressing “LOGIN” the instrument will display a keyboard to type the password, type the password:1990 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”. Now on MAIN MENU will be indicated the “LOGIN: tech level”. Then pressing “Tech” from main menu, the instrument shows the following options


instrument shows the following options:

select “Syringe Auto”, this function allow to setup the excursion of the needle inside the sample tube .

• Up and Down: This option is available on all models; pressing “SET” will be displayed a digital keyboard where 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 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. Pressing “Back” the instrument will display again the Main Menu screen.


13.5 – 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.

Laptop

To/Form Host

Data from Sensors

Mosfet Power Supply

Dedicated Processor

From Main Power Supply

EBCR Port

RS232 Port

USB Port (*)

Bootloader to Upgrade software

Dedicated Processor


13.5.1 – Motor Boards Details In this picture are highlighted in detail each one of the connectors

CPS1 – CPS2 Switching

Board ACK Signal

Automatic Washing Cell

DC Pump

CPS1 – CPS2 Switching

Board “Switching” command

Peristaltic Pump Power

(Trough Switching

Board)

CPS1 CPS2 Thermostatio

n Mosfets

CPS Cooling Fan

CPS1 CPS2 Data (Trough

Switching Board)


External Probe Motor

Carriage Sensors

Motor Board UI Board

Data Cable

Power Supply Cooling Fans

Rotor Motor

Carriage Syringe Motor and Syringe

Sensors


To Motor Board

Technical Door Sensor

Loading Door Sensor

External Probe Sensors

Left Side Tube Sensors

Rotor Sensors

Right Side Tube Sensors


13.6 – Peristaltic Pump New version of Roller20PN uses two independent peristaltic pumps, one for the internal circuit and one for the external circuit. 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 independently and give results to the Unit Interface.

Blood from sample tube

Internal Circuit CPS

Perist. Pump Details

Internal Perist. Pump

Pump Sensor Magnets

External Circuit CPS

External Perist. Pump

Washing Station Pump


13.7 – Reading Unit (CPS) 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. 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.

Dedicated Processor

3 sensors No on board adjustments (all done automatically by software) 1 dedicated DSP Processor

33 LLeedd

33 SSeennssoorrss


13.8. a – Un-mounting the Reading Unit and Capillary Replacement (Internal Circuit) 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. unscrew the fixing screw, 2. remove the screw that keeps the piston in it

place and pull to the front the piston. 3. Pull up the piston to the front 4. Slide out the piston from the syringe group

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 inserting the piston over the syringe, apply the piston fixing screw, mount the needle and the upper terminal, then push beck the syringe to the vertical position and screw in the fixing screw.


13.8. b –Capillary Replacement and Un-mounting the Reading Unit (External Circuit) The same procedure desribed for the internal circuit applieas also to the external one, the only main difference is that instead of removing a needle, it is necessary to remove the external probe.

To remove the external probe just unscrew it from the metallic tongue and the unscrew the treaded terminal from the metallic tongue, finally slid out the capillary till the External CPS and Peristaltic pump. Proceed to replace the capillary following the same procedure explained for the internal CPS and then insert the new capillary in the guide to reach again the external metallic tongue. Screw it in the metallic tongue and finally screw in the external probe.


13.9 – Rotor Motor, Rotor Alignment and Rotor’s Sensors RollerPN 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 .



pressing “LOGIN” the instrument will display a keyboard to type the password, type the password:1990 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”.


Now on MAIN MENU will be indicated the “LOGIN: tech level”. Then pressing “Tech” from main menu, the instrument shows the following options:

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.


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

GOOD ALIGNMENT

WRONG ALIGNMENT

WRONG ALIGNMENT


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.

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

Main Power

Motor

Comm. Board


14 – SOFTWARE UPGRADE INTRODUCTION This procedure describes how to upgrade the operative software of Roller

This procedure must be executed only 1 time to install the “FirmwareLoader” program on the PC. (It is suggested a Laptop). Load the CD supplied with the instrument, access inside “Roller10 Programmer” directory

1. Open Roller10FirmwareLoader.zip 2. Run setup.exe

This installation will create a directory inside C:\Programs\Roller10FirmwareLoader. This new directory is named Roller10FirmwareLoader and also creates a shortcut on desktop named “R10Programmer”. 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.

14.1 – Operative 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, R10-03.00D.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\Roller10FirmwareLoader”,

1. Switch off instrument; 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 Roller10FirmwareLoader (available inside R10Programmer folder on desktop); 4. This window will be displayed on laptop’s screen: Roller10 FirmwareLoader:


5. Select 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. In a Laptop with integrated serial ports, normally the COM number is 1 or 2.

6. Press “Sfoglia” button, then select the appropriate software version file (the more recent release, in this case is R10-03.00D.R10) inside the directory “Roller10FirmwareLoader” and press “OPEN”. The program automatically put it in the field called “Path File”.

7. This is the program's screen after the previous operation:

The check squares are all selected (default option), but if you would or need to program only one or two boards, you can do it selecting/deselecting only the necessary checks.


8. Press “START!” button and only after this, switch on the instrument. 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 5 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. Press OK to close the Roller10 FirmwareLoader window.


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 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

E 0 1 H H H H H Rotor’s home sensor not detected, check if square magnet is present on the rotor

E 0 2 H H H H H Syringe’s home sensor not detected, check if square magnet is present on the piston, check if sensor detects magnet presence

E 0 3 H H H H H Carriage home sensor not detected, check if square magnet is present on the carriage, check if sensor detects magnet presence

E 0 4 H H H H H Not detected home sensor for peristaltic pump even after three complete rotations, check if square magnet is present on the pump’s rotor.

E 0 5 H H H H H Not detected home sensor for external probe, check if square magnet is present on the manual syringe

E 0 6 H H H H H Carriage position 1 sensor not detected, check if square magnet is present on the carriage, check if sensor detects magnet presence

E 0 7 H H H H H Carriage position 2 sensor not detected, check if square magnet is present on the carriage, check if sensor detects magnet presence

E 0 8 H H H H H Not Used

E 0 9 H H H H H Not detected out sensor for external probe, check if square magnet is present on the manual syringe


E 1 1 n H H H H Not Used

E 1 2 - - - - - Not Used


E 1 4 - - - - - CPS. Internal Serial Communication Protocol error, switch off the instrument, wait 10 seconds and switch on again

E 1 5 - - - - - EXT_EEprom. Error during external eeprom access, switch off the instrument, wait 10 seconds and switch on again

E 1 6 - - - - - RTC – Error during internal communication, switch off the instrument, wait 10 seconds and switch on again

E 1 7 - - - - - UI (Unit Interface) – error during writing process on Unit Interface flash memory, switch off the instrument, wait 10 seconds and switch on again

E 1 8 - - - - - COMM. Error during internal data transmission, switch off the instrument, wait 10 seconds and switch on again

E 1 9 - - - - - COMM. Error in the internal protocol, switch off the instrument, wait 10 seconds and switch on again

E 2 0 - - - - - Timeout during SPI transmission to MOTOR switch off the instrument, wait 10 seconds and switch on again board


E 2 1 - - - - - MOTOR. More than one carriage position sensor detected (active) at the same time (physically impossible!) switch off the instrument, wait 10 seconds and switch on again board

E 2 2 - - - - - MOTOR. (syringe) Both sensors sirup and sirdown active at the same time (physically impossible!) switch off the instrument, wait 10 seconds and switch on again board

E 2 3 - - - - - MOTOR. Syringe in sirdown and piston’s sensor not detected. Switch off the instrument, wait 10 seconds and switch on again board

E 2 4 - - - - - MOTOR. (manual syringe) Both sensors sirmanout and sirmanin active at the same time (physically impossible!) switch off the instrument, wait 10 seconds and switch on again board

E 2 5 - - - - - Missing ACK of executed command from Hydraulic Selection Board

E 2 6 - - - - - MOTOR.: Appears after 3 failed attempts to execute the required movement (request 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, for don’t lose the current session, press the “OK” button. When “OK” button is pressed, the instrument automatically try again the last operation (move again the motor) and if this time the error not occurred, continue with the analysis. 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. In the case where an error occurs several times and only if you are a technical operator, is possible to by-pass it, pressing the “square” on the centre of the left side of the screen (the square is invisible), and type the password “1010”.

Then the instrument show the Alifax screen for about 5 second, and after that, show the main screen, without the four principal buttons and automatically is logged in tech mode. Now in this configuration, is possible to enter in tech menu, and also in the other menus, for found what doesn't work correctly or if some sensors are blown. Finally, to use again the instrument in users mode, just switch off it, wait 10 seconds and switch on again.


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 Part Name RSP USER INTERFACE GROUP SI205013 Smart Card Assembly 1 SI205019 Smart Card Flat Cable SI205001 User Interface Gruop with display Lcd Touch Screen SI205018 Printer assembly 1 SI205016 Signal Flat Cable for Printer Assembly SI205017 Flat Cable for User Interface SI205800 Roller10 Thermal Paper SI190418 Stylus Touch Screen (9 pcs) POWER SUPPLY SI205020 Switching Mode Power Supply 115VA 1 SI205021 Back Panel Fans, Cabled (with 2x24v coils) SI205022 Power Supply Cable 220V ( Mains Intlet Group-Power Supply Board ) SI205050 220V Power Supply Cable SI195080 Mains Fuses 5x20 T 2,5A (10 pcs/box) 1 SI195085 Mains Cable SI205024 Mains Inlet Group, complete with fuses MOTORS CONTROL GROUP SI205025 Motor Control Board 1 CARRIAGE COMPONENTS SI205026 Syringe Group Sensors Board 1 SI205027 Syringe Geared Motor, cabled SI205029 Carriage Flat Cable 1 SI205056 Carriage complete assembly for R20-PN SI205061 Carriage stepper Motor SI205064 Carriage position sensors Board 1 WITHDRAWAL GROUP

SI195077 Metal Screw Needle Complete Of Plastic Replacing Tool And Cleaning Wire (Spicilum) 1

SI195092 Tube Sensor Inserted Into Syringe Support – Cabled For instruments with SI1951000 kit

SI1951001 Security Locking Block for metallic piston SI1951002 Metallic Safety Withdrawal Group SI195751 Top Piston Rotating for Terumo Tubes SI195752 Top Piston Rotating for Standard Tubes SI195753 Top Piston Rotating for Sarstedt Tubes SI195754 Plastic Piston complete without Rotating Top 1 SI205010 External probe sensor board 1 SI205030 Metal Piston For CBC Adapters SI205062 External tip Motor SI205065 External Needle 1

HYDRAULIC CIRCUIT


SI105065 DC Pump Complete For Washing Cell SI195036 Pump Head Complete (Without SI195014) SI205034 Pump Sensor Assembly 1 SI205057 Tubing kit for washing cell for R20-PN ( 1 pcs )

SI205069 Complete Internal tubing kit with Click'n Seal connectors From R20 PN sn 001 to sn 091 1

SI205070 Internal Withdrawal to Valve tubing with Click'n Seal connectors (1 pcs)

SI205071 External Withdrawal to Valve tubing with Click'n Seal connectors (1 pcs) From R20 PN sn 001 to sn 091

SI205073 Tubing kit through CPS for R20PN with rotating valve (Tecan) From R20 PN sn 001 to sn 091

SI205074 Waste tubing kit for Roller20-PN with rotating valve (Tecan) From R20 PN sn 001 to sn 091

SI205075 Complete tubing kit Click’n Seal for double CPS Roller20-PN From R20 PN sn 092 to sn XXX 1

SI205076 Complete tubing kit for internal withdrawal for double CPS Roller20-PN From R20 PN sn 092 to sn XXX

SI205077 Complete tubing kit for external withdrawal for double CPS Roller20-PN From R20 PN sn 092 to sn XXX

SI205078 Internal withdrawal tubing kit for double CPS Roller20-PN From R20 PN sn 092 to sn XXX 1

SI205079 External withdrawal tubing kit for double CPS Roller20-PN From R20 PN sn 092 to sn XXX

SI205080 Internal waste tubing kit for double CPS Roller20-PN From R20 PN sn 092 to sn XXX

SI205081 External waste tubing kit for double CPS Roller20-PN From R20 PN sn 092 to sn XXX

SI205801 Roller10 Waste Tank

SI804209 Pump Tube Kit (1 pcs) For instruments with SI205069 Kit ( Click'n Seal connectors ) 1

SIF70606 Tube Holder Clamp ANALYTICAL COMPONENTS SI205033 Pump Geared Motor, complete SI205048 Analogical flat cable

SI205066 Cps Module for Roller10 Family - Complete Of Preamplifier And

Thermostat Boards ( Without tubing kit ) SIBK7320 Glass Flat Light Diffusor For Cps Module 1 TURNTABLE MIXER GROUP SI102033 Spring for retaining rotor tubes (10 pcs) 1 SI205041 Sensors board DX for tubes R10 1 SI205042 Sensors board SX for tubes R10 1 SI205043 Home Rotor Sensor Board 1 SI205044 Front Door Sensor, Cabled 1 SI205045 Access syringe door sensor, cabled SI205046 Roller Rotor Motor, cabled SI205054 Rotor Toothed belt CONNECTION GROUP INSTRUMENT-PC SI205047 Communication Board 1

SI195832 Passthrough Serial Cable Rs232 For Test1 Qc Software - 1,8 Meters

1,8 mt long, with through connector DB25F - DB25M and DB9F terminator

SI195833 Passthrough Serial Cable Rs232 For Test1 Qc Software - 5 Meters

5 mt long, with through connector DB25F - DB25M and DB9F terminator SI205834 RS232 Serial RS232 Cable For Host Or Query Host Connection PLASTIC COVER


SI205055 White Cover for R10 family (Old Version) From R10 PN sn 001 to sn 030 / From R20 PN sn 001 to sn 039

SI205059 White Cover for R10 family (New Version) From R10 PN sn 031 to sn XXX / From R20 PN sn 040 to sn XXX

SI205060 White Front Door for R10 Cover (New version) From R10 PN sn 031 to sn XXX / From R20 PN sn 040 to sn XXX

SI205072 Front Door Latch ACCESSORIES

SI195820 Manual External Bar Code Reader (65mm CCD scanner with serial RS232 interface and cable)

SI205052 Adapter for Paediatric Test Tubes

SI195.948 Transfer Card Allows the transfer of test availability from one instrument to another, personalization included


20.0 - ROLLER – REFERENCES

Manufacturer:

SIRE Analytical Systems s.r.l. Via Merano 30 33045 Nimis (UD) Italy Tel +39 0432 547454 - Fax +39 0432 547378

Company certified by ISO 9001:2008 TÜV Italia S.r.l. 501006107 EN ISO 13485:2012/AC:2012 TÜV SÜD Product Service GmbH Q1N130371065001 ISO 13485:2003 (CMDCAS) TÜV SÜD America Inc. QS1130471065002

The instrument is CE certified According to directive 98/79/EC relative to In Vitro Diagnostic Medical Devices

Worldwide distributor::

ALIFAX S.p.A. via F. Petrarca 2 Isola dell'Abbà 35020 Polverara (PD) Tel. +39-049-0992000 e-mail [email protected] web www.alifax.com

APPENDIX A - IMPROVEMENTS WITH SOFTWARE VERSIONS from 1.00A to 3.X

http://www.alifax.com/


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.

Version 2.00 B Introduced a software function that checks priming procedure; in case priming procedure goes wrong, this

new function requires a washing procedure. Separated BoosterY from ModelFact in the ESR calculations (Latex Std: BoosterY = MFact average, Not

Latex Std, BoosterY different from MFact average) Improved software function that manages latex control.

Version 3.00 A Not released to the market


Version 3.00 B Introduced a double CPS and separated the hydraulic circuits, one for internal sampling and one for

external sampling. Removed Rotating Valve Introduced priming also for latex to improve latex controls and calibrations.

Version 3.00 C Solved a problem of Host Communication; in release 3.00B the results from sample 11 to 20 were not sent

to host. Possible to restore last session if the instrument will switch off.

Version 3.00 D Not released to the market

Version 3.00 E Improved error handling Solved a problem of Host Communication; in release 3.00C in case of Sample Missing (S.M.) was sent to

the host “-000” code instead “-001” Second analysis of the sample if the first result is NF(-4) or NR(-2) Introduced pediatric mode with centrifugation of samples Introduced new BoosterY for Sodium Citrate Introduced new datalogger for calibrations with latex

Version 3.00 F Solved missing sound with datalogic barcode


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 4. Perform a first wash using two tubes filled with distilled water � � 5. Perform a second wash using one tube filled with water and one tube filled with sodium hypochlorite � � 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 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 4. Perform a first wash using two tubes filled with distilled water � � 5. Perform a second wash using one tube filled with water and one tube filled with sodium hypochlorite � � 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

In the event contaminated material is penetrated inside the instrument (thermostated plate) IT IS MANDATORY TO INDICATE ON the INSTRUMENT and on the SANITATION SHEET that contaminated material has percolated inside the instrument and it has not been possible eliminate using the external sanitation procedure.

MANDATORY: If the sanitation was carried on, please cut the lover right side of the page (or make a photocopy) and include the tag in the shipping documents

SANITIZED

Documents

Alifax Roller 20 Service Manual · ESR_TM_SIR20-XX_ROLLER20-SW3_2-10_EN Roller PN Service Manual Page 4 . INSTRUMENT PLASTIC COVER REMOVING . To remove instrument’s plastic cover