Iris roller-20 Service Manual

301-4480 Revision AA

Alifax Roller 20 Service

Manual

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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

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.

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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

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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 m eani ng .................................................................... 52

9.1.6.3.b – INTERPRETATION OF THE STATI STICAL MEANING ....................................................................................... 54

9.1.6.4 – “NORMAL” CUMULATIVE ESR DISTRIBUTION PRINTOUT - Graph meaning ..................................................... 56

9.1.6.5 – “GLOBAL” CUMULATIVE ESR DISTRIBUTION PRINTOUT - Graph m eaning ...................................................... 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 VERIFICATI ON 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

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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 developm ent). .................................................................................................. 91

9.4.1.9 – Curve Parameters Transmission (under dev el opm ent). ........................................................................................... 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

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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.

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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

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Retractable Tip for external

withdraw (useful for tubes with

plastic cap and/or paediatric tubes)

External Tip

motor

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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

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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

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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 Sedimentat ion R ate (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 unc apped.

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 automati c 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 bl ood 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 micr oliter s 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 bet ween manual and automatic procedure perfor med with Roller 20 PN it is mandator y to

open the cap of the tube both for automatic - manual procedur e 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).

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Automatic withdraw al:

• 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 ho ur) 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 rot ations, 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 cons idered 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 mor e than 1 second.

Error notice:

The instrument in case of error or malfunc tion, reports this situation with a spec ific 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: R

= 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 ro om temperature:

In order to view the effects of different methods of storage on the ESR value, 272 K

EDTA- 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 s am pl es 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 erythroc yte 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, plas ma 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 abov e variables are not taken into account.

2. Erythrocyte sedimentation remains an only partly understood phenomenon….is a nonspecif ic 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 m ention the Erythrocyte Sedimentation Rate

(4)

. It is then necessary to point out that even though TEST1

analytical performances have been confirmed in patients affect ed by multiple myeloma

(5,6)

, there

have been some cases of patients affected by multiple myeloma in which TEST 1 has reported clinically negative ESR values in comparison to other methods. Based on this experience there could be cases in which Roller gives low ESR results likewise TEST1 in presence of Multiple Myeloma.

It is then highly recommended to perform other tests t ogether 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.

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Furthermore in presence of this dis ease it is possible to observe deviations form other m ethods since other phenomena in addition to the rouleaux format ion can contribute to the sediment ation 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-clot s presence can affect the result given by the instrument that in fact measures erythrocytes aggregation kinetics.

4. The above instrument performances have been obt ained using test tubes with a capacity of 3 ml and 13x75 mm size with K

EDTA anticoagulant. The use of such tubes opti mizes 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 rem ain 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)

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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 Eryth rocyte Sedimentation Rate”, May 2002, private communicati on

2. NCCLS “Reference and Selected procedure for the Erythrocyte Sedimentation rate (E SR) 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 “Multip le 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 affect ed by myeloma”,

37° SIBioC National Congress, 11-14 October 2005 Rome.

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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 sy ringe group, li ke 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 inst rum ent 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 t hei r anal ysis

 Fol l ow the "WASHING PROCEDURE" for a good maintenance of the instrument.  For professional in vitro medical diagnostic use only.  The i nst rument 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.

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 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 wast e of electrical and electronic equipment (WEEE) appropriate

measures should be adopted to minimize the disposal as unsorted municipal w aste 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 s ide, 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 it s 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 l aws and the rules in the nation of use. T he penalties will be

effective, proportionate and dissuasive.

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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 cod e

Attention, see instructions for use

Manufacturer

Ground terminal lug on the equipment.

In Vitro Diagnostic Medical Device

Serial Number

Caution: Moving Parts Inside

Caution: Biological Risk

Caution: Laser Radiation

Caution: High Voltage

Caution: Sharp Objects Inside

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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 Informativ e 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 el evators. 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.

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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

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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.

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• 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.

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

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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 (BASICAL LY 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

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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 remov e 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

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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 t he whole T echnical M enu, 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

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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.

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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 fol lowing m essage:

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

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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 m essage:

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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

9.1.1.3 – 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 fol lowi ng m essage:

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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

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

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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.

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+ 142 hidden pages

Iris roller-20 Service Manual

Specifications and Main Features

Frequently Asked Questions

User Manual