esr um si195 test1 sw6-51 1-2 en · user manual test1 rev.1.2 – 2015.10.10 user manual...

Rev.1.2 – 2015.10.10

USER MANUAL

Valid for Software Version 6.51E

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

Module T patent pending

In Vitro Diagnostic Medical Device for professional use

Copyright Alifax S.r.l. This manual contains ALIFAX reserved information. All rights reserved.

Unauthorized copying of this manual or parts of it is prohibited. The TEST 1 family software is provided only with restricted and limited rights based on Italian regulations.

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Rev.1.2 – 2015.10.10

USER MANUAL ESR_UM_SI195_TEST1_SW6-51_1-2_EN Pag 1

INDEX

1- TYPOGRAPHICAL CONVENTIONS ............................................................................................................................. 3

DISPLAY of WARNINGS and NOTES ............................................................................................................................................... 3

USED WARNINGS SYMBOLS .......................................................................................................................................................... 3

OTHER SYMBOLS ............................................................................................................................................................................ 4

2- TECHNICAL DATASHEET ESR_PTDS_SI195_TEST1_1-2_EN – 2015. 10. 10 ........................................................ 5

3- WARNINGS FOR A CORRECT USE OF THE INSTRUMENT .................................................................................... 12

GENERAL SAFETY ......................................................................................................................................................................... 12

OPERATIVE SAFETY ..................................................................................................................................................................... 13

MECHANICAL SAFETY .................................................................................................................................................................. 14

ELECTRICAL SAFETY .................................................................................................................................................................... 14

BIOLOLGICAL SAFETY .................................................................................................................................................................. 16

LASER SAFETY .............................................................................................................................................................................. 17

TEST1 SAFETY LABELS AND TYPE LABELS ............................................................................................................................... 17

4- UNPACKING AND INSTALLATION............................................................................................................................. 18

5- INSTRUMENT DESCRIPTION and start-up ................................................................................................................ 18

6- VOLTAGE SELECTOR AND FUSES REPLACEMENT .............................................................................................. 19

7- KEYBOARD SPECIAL FUNCTIONS ........................................................................................................................... 20

8- SWITCH ON THE INSTRUMENT ................................................................................................................................ 21

9- TANK EMPTYING / REPLACING ................................................................................................................................ 21

10- MAIN MENU OPTIONS ............................................................................................................................................... 22

11- CHANGE DATE & TIME .............................................................................................................................................. 22

12- PROCEDURE FOR PAPER LOADING INTO THE PRINTER ..................................................................................... 23

13- AVAILABILITY TEST INCREASING ............................................................................................................................ 24

14- UNIVERSAL CARD ..................................................................................................................................................... 25

15- SMART CARD ERRORS ............................................................................................................................................. 25

16- RACK CONFIGURATION ............................................................................................................................................ 26

17- USE OF PAEDRIATIC TEST-TUBE ............................................................................................................................ 29

18- STARTING ANALYSIS SESSION ............................................................................................................................... 30

PROGRAMMING TEST1 WITH AUTOMATIC ID’s (for TEST1 THL only) ................................................................................................. 30

PATIENT IDENTICY CODES READING BY MEANS OF EXTERNAL BAR CODE READER (on TEST1THL only) .................................. 30

PATIENT ID INTRODUCED BY KEYBOARD AND CORRECTION (for TEST1 THL only) ......................................................................... 32

ANALYTICAL CYCLE ON ANALYSERS EQUIPPED BY DIRECT INSERTION KIT ........................................................................ 34

ANALYSIS CYCLE .......................................................................................................................................................................... 37

END OF CYCLE .............................................................................................................................................................................. 38

RESULT REPRINTING .................................................................................................................................................................... 38

ESR ALIGNMENT VALUES............................................................................................................................................................. 38

RACK EXTRACTION ....................................................................................................................................................................... 38

19- NOTE for the analysis cycle and washings ................................................................................................................. 39

20- MAINTENANCE TIME ................................................................................................................................................. 39

21- WASHING PROCEDURE ............................................................................................................................................ 40

WASHING USING 2 TEST TUBES ................................................................................................................................................. 40

WASHING USING 3 TEST TUBES ................................................................................................................................................. 40

WASHING PROCEDURE FOR MAINTENANCE (useful even to unlock the needle and capillary ) ........................................................................ 40

WASHING PROCEDURE IN CASE OF DAILY CONTROLS BY MEANS OF LATEX KIT ............................................................... 41

22- QUALITY CHECK USING LATEX CONTROL KIT ...................................................................................................... 42

23- INTERNAL QUALITY CONTROL SYSTEM PRESENTATION .................................................................................... 44

INSTRUMENT QUALITY CONTROL USING LATEX CONTROL KIT .............................................................................................. 45

HEMATIC STATISTICAL DATA PRINTOUT .................................................................................................................................... 46

DISTRIBUTION PRINTOUT ............................................................................................................................................................ 50

WATER DATA PRINTOUT - Graph meaning................................................................................................................................... 52

24- ERRORS LIST ( from version 5.00C onwards ).

.......................................................................................................................... 53

25- ESR AND LATEX ERRORS LIST ................................................................................................................................ 56

26- APPENDIX A - USE OF TEST1-THL WITH DIFFERENT TYPES OF RACKS ............................................................ 57

CORRECT WAY TO INSERT TEST-TUBES IN THE RACK : ......................................................................................................... 58

27- NEEDLE REPLACEMENT PROCEDURE ................................................................................................................... 59

APPENDIX B – NEEDLE REPLACEMENT PROCEDURE on piston SI195.021/V, SI195.022/V SI195.023/V up to sn 1793 .......... 60

APPENDIX C – NEEDLE REPLACEMENT PROCEDURE on piston SI195.021/M/D from sn 1794 till sn 2137 ............................... 64

APPENDIX D – NEEDLE REPLACEMENT PROCEDURE from sn 2138 onward ............................................................................ 67

28- APPENDIX E – LATEX CODES TYPED MANUALLY ................................................................................................. 69

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29- IMPROVEMENTS WITH SOFTWARE VERSIONS (from 5.00C onwards)

............................................................................. 70

30- SANITIZATION PROCEDURE .................................................................................................................................... 73

31- SWITCH OFF THE INSTRUMENT .............................................................................................................................. 73

32- TEST1 - REFERENCES .............................................................................................................................................. 74

33- APPENDIX F – SANITIZATION FORM ....................................................................................................................... 75

Note: Paragraphs written on italic blue characters, point-out an update or modification in the manual as regards the previous version.

We reserve the right to make changes in the course of technical development without previous notice.

Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval of Alifax S.r.l.

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1- TYPOGRAPHICAL CONVENTIONS

The warnings, notes and symbols described hereafter are used in the current manual, on the instrument and on its packaging.

DISPLAY of WARNINGS and NOTES

The signal word "Danger" and a relating symbol point to imminent dangers. The non-observance of a danger warning can result in death or at least serious irreversible injury. A damage of the system or an adverse effect on the system function cannot be excluded. The signal word "Warning" and a relating symbol points to potential dangers. The non-observance of a warning can result in death or at least serious irreversible injury. A damage of the system or an adverse effect on the system function cannot be excluded. The signal word "Caution" and a relating symbol point to potential dangers/ problems. The non-observance of safety instructions can result in minor injuries. A damage of the system or an adverse effect on the system function cannot be excluded. The signal word "Caution" points to potential problems. The non-observance of a safety instruction can result in damage of the system or an adverse effect on the system function.

The signal word "Note" points to potential problems. The non-observance of notes can result in an adverse effect on the system function (result deterioration).

USED WARNINGS SYMBOLS

Caution, risk of danger to person or damage to equipment!

Consult instructions for use!

Biohazard! Caution, moving parts inside!

Electrical hazard! Mechanical hazard! ù

Laser hazard! Cut injury / sharp hazard!

Ground! Automatic start-up!

Consult instructions for use

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OTHER SYMBOLS

Manufactured by Lot number Expiration date Temperature limitations

CE mark ID number Serial number

Disposal of Electrical and Electronic Equipment

In the European Union, electrical and electronic equipment must not be disposed of with other household-type waste. It must be collected separately. Please observe the relevant legal regulations effective in your country. Following labels refers to TEST1 THL and contains between others the reference serial number of the instruments

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2- TECHNICAL DATASHEET ESR_PTDS_SI195_TEST1_1-2_EN – 2015. 10. 10

OPERATIONAL SPECIFICATIONS

Equipment name: TEST1 THL (SI 195.210/THL) - Model with thermoplastic white cover and Latex Control management.

TEST1 BCL (SI 195.220/BCL) - Model with thermoplastic white cover, Latex Control management and configured with direct insertion of Beckman Coulter LH 700 SERIES cassettes and Alifax green plastic racks.

TEST1 SDL (SI 195.230/SDL) - Model with thermoplastic white cover, Latex Control management and configured with direct insertion of Sysmex SF/SE/XE Cell Blood Counters cassettes and Alifax yellow plastic racks.

TEST1 YDL (SI 195.240/YDL) - Model with thermoplastic white cover and Latex Control management. and configured with direct insertion of BAYER/SIEMENS ADVIA 120 Cell Blood Counter cassettes and Alifax blue plastic racks.

TEST1 MDL (SI 195.250/MDL) - Model with thermoplastic white cover and Latex Control management and configured with direct insertion of Beckman Coulter LH500 Cell Blood Counter cassettes.

TEST1 XDL (SI 195.260/XDL) - Model with thermoplastic white cover and Latex Control management and configured with direct insertion of Beckman Coulter DxH 800 Cell Blood Counter cassettes.

Intended Use: Automatic analyser for Erythrocyte Sedimentation Rate (ESR) determination.

Principle of measure: Photometrical capillary stopped flow kinetic analysis.

Results: ESR: results are printed in mm/h on the range from 2 to 120 mm/h.

Sample requirements:

• The sample must be whole blood collected in EDTA anti-coagulant.

• The blood sample must be neither coagulated nor hemolyzed.

• It would be better to test the sample within 4-6 hours from venipuncture or within 24 hours if kept at +4/+8 °C, provided it is rewarmed to room temperature before testing.

• The minimum blood volume (dead volume) is 800 microliters.

• The working volume is 175 microliters (average) with the exception of the first two samples for which further 116+/-10% microliters are needed for priming (232+/-10% in case there is only one sample).

• Samples separation into the capillary using air bubble of about 530 mm (255 microlitres).

Tube requirements: Test-tubes 13x75 mm like BD Vacutainer® or Greiner Bio-one Vacuette® or with 13 mm diameter and from 75 to 83 mm high, cap included (like for example the Sarstedt Monovette® tubes that measure 11,5x66 mm without cap). The Sarstedt Monovette® tubes need specific adapters (please refer to the Price list). Tubes with 95 mm can be used with the Alifax 15 positions metal rack (code SI195500) only on TEST1 THL. It is suggested the sample volume should not exceed the 50-60% of the total volume of the test-tube.

Only for TEST1 THL: Optional Terumo® cap adapter for Terumo Venojet II

® tubes

Optional Sarstedt® cap adapter for Sarstedt Monovette

® tubes

Operative performances: Samples mixing can be programmed in speed (60, 32 and 23 RPM) and in number of rotations, from 5 to 1000 rotations (recommended 32 RPM @ 140 rotations, about 4,4 minutes of mixing time). -First result available after 4,4 minutes of mixing and 20 seconds of analysis, the other results (from 2

nd to 60

th) are given every 20 seconds.

60 samples processed in 24 minutes (150 samples per hour) without considering the time taken for loading and unloading the rack from the instrument. -The above throughput could be reduced in case of connection to the Host Computer with reply output time more than 1 second. -Audible alarm in case of error or malfunction: The instrument emits a series of 62,5dBA sounds until the error is solved.

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-The instrument is equipped by an internal Scanner programmed to read codes such:

• CODE 39 • 2/5 INTERLEAVED • CODABAR • CODE 128 • EAN 128 • ALL EAN/UPC

In the event customer uses collecting tubes with 4ml capacity, it is possible to obtain good correlation with the method used into the laboratory with the following tips:

1. Using the gain of the instrument during correlation with lab reference method 2. Increasing the mixing time (this can be obtained using an external mixer before the

ESR analysis or/and increasing the mixing time of the ESR analyzer). 3. If the CBC has the venting function, possibly execute first the CBC analysis and then

the ESR analysis.

Capacity: TEST1 THL: Standard TEST1 racks, up to 60 samples / session, Cell Blood Counter adapters, from 40 to 48 samples / session.

TEST1 BCL: ALIFAX green plastic racks, up to 60 samples / session, CBC Beckman Coulter LH 700 SERIES cassettes, 48 samples / session.

TEST1 SDL: ALIFAX yellow plastic racks, up to 40 samples / session, up to 40 samples / session with Sysmex SF/SE/XE Cell Blood Counters cassettes.

TEST1 YDL: UP to 40 samples / session with BAYER/SIEMENS ADVIA 120 Cell Blood Counters cassettes. ALIFAX blue plastic racks, up to 40 samples / session.

TEST1 MDL: Up to 40 samples / session with Beckman Coulter LH500 Cell Blood Counters cassettes.

TEST1 XDL: UP to 40 samples / session with Beckman Coulter DxH 800 Cell Blood Counters cassettes.

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

Intra-Assay Reproducibility (Repeatability): The intra-assay precision has been evaluated by performing 10 replicates of 7 K3 EDTA-anticoagulated fresh whole blood samples with ESR values ranging from 10 mm/h to 117 mm/h. The following results have been obtained

(1):

Sample ESR Mean +/- SD (mm/h) Coefficient of Variation (%) 1 10 +/- 0.86 7.52 2 15 +/- 0.49 3.28 3 23 +/- 0.87 3.77 4 33 +/- 1.48 4.49 5 46 +/- 1.51 3.29 6 56 +/- 1.51 2.70 7 117 +/- 3.32 2.83

Overall CV(%) 3.98

Reproducibility: Evaluated by comparing two instruments on the whole range from 2 to 120 mm/h using the same samples (60 samples) of blood: R = 0,984, Slope: 1,0071

Correlation with ICSH reference method (Westergren in EDTA): it has been evaluated on 509 K3 EDTA-anticoagulated fresh whole blood samples with a different range of hematocrit values. The following results have been obtained

(2):

Y=0.92 x + 3.54; r=0.93

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and, grouping the above 509 samples in 10 classes on the basis of ESR values:

ESR values range (mm/h)

BIAS Upper and Lower Limits of the Bias

95% Confidence Interval of the Bias

2-10 1.77 -6.10 – 9.65 0.90 – 2.64 11-20 -0.94 -15.94 – 14.05 -2.56 – 0.67 21-30 -1.43 -14.96 – 12.10 -3.24 – 0.38 31-40 -1.35 -15.63 – 12.92 -3.54 – 0.83 41-50 3.42 -17.76 – 24.61 -0.03 – 6.88 51-60 2.29 -26.46 – 31.05 -2.59 – 7.18 61-70 1.7 -28.32 – 31.72 -3.19 – 6.59 71-80 4.4 -21.32 – 30.12 -0.50 – 9.30 81-90 4.41 -31.18 – 40 -4.92 – 13.75 91-100 -1.7 -46.63 – 43.23 -18.09 – 14.69

Stability of samples stored for 24 h at 4 °C: It has been evaluated on 1140 K3EDTA-anticoagulated whole blood samples comparing the results obtained within 4 hours from the sample collection and 24 hours after storage at +4 °C. The following results have been obtained

(2):

ESR values range (mm/h)

BIAS Upper and Lower Limits of the Bias

95% Confidence Interval of the Bias

2-10 0.32 -3.18 – 3.82 0.13 – 0.50 11-20 1.05 -5.74 – 7.85 0.60 – 1.51 21-30 1.92 -13.29 – 17.14 0.56 – 3.3 31-40 4.32 -5.85 -14.5 3.23 – 5.42 41-50 4.18 -8.83 – 17.2 2.37 – 6.0 51-60 4.14 -12.84 – 21.13 1.16 – 7.12 61-70 5.83 -13.67 – 25.33 2.04 – 9.61 71-80 9.38 -15.28 – 34.04 4.59 – 14.16 81-90 10.17 -12.35 – 32.70 4.26 – 16.08 >90 9.55 -6.32 – 25.43 6.81 – 12.96

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. Good correlation was found between the results taken at 4 hrs and those at 24 hrs on the samples stored at 4 °C (r=0.980). Those stored at room temperature did not correlate quite as well as those stored at 4 °C, but still had very good correlation (r=0.917)

(3).

Carry-over: it has been evaluated alternating samples with a low ESR value with samples characterized by a high ESR value and it is given by the following formula: (affected value – unaffected value)/ affecting value. It has been found not to exceed +/- 4.5% on the average basis.

Method limitations: 1. “The erythrocyte sedimentation rate is a phenomenon confined to fresh blood and transient”

(4), 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.)

(4). Based on the acquired experience, TEST1 family instruments (TEST1,

MicroTEST1, Roller10 and ROLLER 20) are affected by these variables to a limited degree. For this reason it is possible to observe instrument performances deviations compared to other procedures if the above variables are not taken into account.

2. “Erythrocyte sedimentation remains an only partly understood phenomenon….is a nonspecific reaction (from a clinical point of view)…”

(4) that is affected by several technical

aspects (5)

. “The ESR is often normal in patients with cancer...” (5)

. International guidelines for diagnosis and management of multiple myeloma do not mention the Erythrocyte Sedimentation Rate

(6). However there are national guidelines that include

ESR together with other clinical tests. It is then necessary to point out that even though TEST1 analytical performances have been confirmed in patients affected by multiple myeloma

(7;8), there have been some cases of patients affected by multiple myeloma in

which TEST1 Laboratory ESR Analyser has reported clinically negative ESR values in comparison to other methods. 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

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sedimentation like for example amorphous aggregates formation (crystallization of paraproteins or mineral materials like calcium) resulting from bone tissue alteration.

It is then highly recommended to perform other tests together with TEST1 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.

3. Samples mixing is programmed at the beginning of the analysis with the purpose of disaggregating erythrocytes. An inefficient disaggregation or micro-clots presence can affect the results given by the instrument that in fact measures erythrocytes aggregation kinetics.

4. The above instrument performances have been obtained using test tubes with a capacity of 3 ml and 13x75 mm size with K3EDTA anticoagulant. This kind of tubes has a sufficient air volume that favours the blood homogenization and consequently the results reproducibility.

ENVIRONMENTAL AND 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: 480 +/- 3 mm Depth: 539 +/- 3 mm

Height: 595 +/- 3 mm Weight: 47,4 +/- 0.5 Kg

41 +/- 0,5 Kg (only THL) Packaging: Cardboard box Width: 660 mm Depth: 610 mm Height: 840 mm Gross Weight: 54 Kg Volume: 0,3382 m

3

Pallet: Yes

ELECTRICAL SPECIFICATIONS

Voltage: 230 Vac ± 10% or Power cons: 150 VA, circa 83W 115 Vac ± 10% selectable with voltage selector Switch on cons: 225 VA, circa 135 W Frequency: 50 or 60 Hz ± 2 Hz Classification: Class I (EN61010-1 – IEC 1010-1 – CEI 66-5)

OTHER OPERATIVE SPECIFICATIONS:

Heat dissipation in the environment: about 300 BTU/hour Noise: at low speed mixing: 62,6 dB(A)

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at high speed mixing: 58,2 dB(A) Maximum rated altitude: 3000 mt asl Communication: 2 serial RS232 DB 25 ports located on the rear side of the instrument:

Port 1 is dedicated to connect an external scanner Port 2 is dedicated to connect the instrument to an Host Computer Note: if the Internal Bar Code Reader (IBCR) is used, it is not possible to connect an external scanner unless a technical setup is done inside the instrument.

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 good capillary and sensor’s life.

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

CONSUMABLES

Printer Paper: Thermal roller 57 mm x 25 meters (code SI19580001 4 rolls)

Smart Card: Conform to ISO 7816-1 specifications - 85.6 x 54 x 0.8 mm - coded using Alifax proprietary algorithm. Available for 1,000 (code SI 195.901) - 4,000 (code SI 195.904) - 10,000 (code SI 195.910) - 20,000 (code SI 195.920) tests/ Universal Card for the TEST1 family instruments (TEST1, MicroTEST1, Roller10, ROLLER 20).

Waste Tank: 500 ml plastic waste tank with screw cap (code SI195801).

INTERNAL QUALITY CONTROL Latex Controls: Latex Controls for TEST 1 family analyzers allow the control of the calibration stability of TEST1,

MicroTEST 1; Roller 10, Roller 20 and JO-PLUS. They are available in two kinds of test tubes: ♦ 13x75mm Greiner: Latex Controls (6 tests) - code SI 305.100-A; Latex Controls (30 tests) – code SI 305.300-A. ♦ 11,5x66mm Sarstedt: Latex Controls (6 tests) - code SI 305.102-A;

Latex Controls (30 tests) - code SI 305.302-A. TEST 1 Family Quality Control: it is a software (code SI19562001) designed to collect and process the data from one or

more TEST1 family analyzers (TEST1, MicroTEST1, Roller10, ROLLER 20 and JO-PLUS) for evaluating their performances.

OPTIONAL AVAILABLE TOOLS

Patient identification: External CCD bar-code reader (SI195820) or Internal Laser Scanner bar-code reader (DS 11002111).

ADAPTERS (for TEST1 THL only):

SI195500 TEST1 - Standard rack for TEST1 with Internal Bar Code Reader (IBCR) (15 positions) SI195510 BAYER/SIEMENS - Adapter for Bayer/Siemens Advia 120 Cell Blood Counter racks (10 positions) SI195540 ABBOTT L - Adapter for Abbott Cell-Dyn 4000/3200 CBC racks (long type - 10 positions) SI195540 As the previous, but with retaining comb for Sarsted test-tubes SI195542 ABBOTT - Adapter for Abbott Cell-Dyn 3500/3700 CBC racks (short type) or for Sysmex SF/SE/XE CBC

racks or for ABX Pentra 80 CBC racks (short type - 10 positions) SI195542 As the previous, but with retaining comb for Sarsted test-tubes SI195550 ABX - Adapter for ABX Pentra 120 Cell Blood Counters racks (10 positions) SI195580 COULTER M - Adapter for Beckman Coulter LH 500 CBC (keeps 2 racks of 5 positions each)

KITS TO CONVERT TEST1 THL TO INSTRUMENTS FOR LOADING CBC CASSETTES DIRECTLY:

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SI195320 Kit for the direct insertion of the LH 700 SERIES 12 positions rack from Beckman Coulter cell blood counters. The same direct insertion can also accept, without any modification, the new Alifax green plastic rack with 15 positions (code SI195505).

The application of this kit is however possible only on instruments equipped with Internal Bar Code Reader (kit code SI195400).

SI195330 Kit for the direct insertion of the Sysmex SF/SE/XE 10 positions rack from Sysmex cell blood counters. The same direct insertion can also accept, without any modification, the new Alifax yellow plastic rack with 10 positions (SI195506).


SI195340 Kit for the direct insertion of the BAYER/SIEMENS ADVIA 120 10 positions rack directly from SIEMENS/ BAYER cell blood counters. The same direct insertion can also accept, without any modification, the new Alifax blue plastic rack with 10 positions (SI195507).


SI195350 Kit for the direct insertion of the Beckman Coulter LH500 rack directly from the BECKMAN COULTER cell blood counters. Each direct insertion carries 2 mini-cassettes of 5 positions each.


SI195360 Kit for the direct insertion of the SYSMEX 10 positions rack directly from SYSMEX cell blood counters. It has been designed specifically to manage Sarstedt test-tubes.


SI195370 Kit for the direct insertion of the COULTER DxH 800 rack directly from the Beckman COULTER

cell blood counters. Each direct insertion carries 2 mini-cassettes of 5 positions each. The application of this kit is however possible only on instruments equipped with Internal Bar Code

Reader (kit code SI195400).

VARIOUS / OTHER FEATURES

Common features:

• New design with thermoplastic cover, front door for easy access to waste tank and needle.

• Simplified needle replacing procedure with magnetic unlocking and screw needle.

• Simplified Smart Card downloading using a single operation.

• Automatic washing alarm request programmable between 5 and 180 minutes from the last

processed sample.

• Photometer check during each washing, to ensure continuous control of the instrument.

• Management of Latex Controls Kit for TEST1 family analysers SI 305.100-A/SI 305.102-A (6 tests) – SI 305.300-A/SI 305.302-A (30 tests): for the control of the calibration stability of the instrument.

• New latex controls management algorithms for a best equalization of different instruments.

• New priming procedure that withdraws the blood from the first two available test-tubes, half

cutting in this way the volume that previously was withdrawn only from the first test tube.

Specific features: TEST1 BCL: This model is set mechanically and also from software point of view, to receive and handle directly, without any kind of adapter, Beckman Coulter LH 700 SERIES CBC cassettes and without further modifications, also the new ALIFAX green plastic rack for 15 positions (code SI19550501).

TEST1 SDL: This model is set mechanically and also from the software point of view, to receive

and handle directly, without any kind of adapter, Sysmex SF/SE/XE CBC cassettes and without further modifications, also the new ALIFAX yellow plastic rack for 10 positions (code SI19550601).

TEST1 YDL: This model is set mechanically and also from the software point of view to receive

and handle directly, without any kind of adapter BAYER/SIEMENS ADVIA 120 cassettes.

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TEST1 MDL: This model is set mechanically and also from the software point of view, to receive and handle directly, without any kind of adapter Beckman Coulter LH500 cassettes.

TEST1 XDL: This model is set mechanically and also from the software point of view, to receive and handle directly, without any kind of adapter Beckman Coulter DxH 800 cassettes.

REFERENCES:

(1) M. Plebani, S. De Toni, M.C.Sanzari, D. Bernardi and E. Stockreiter: “The TEST1 Automated System”, American Journal of Clinical Pathology, Vol. 110, 1998

(2) M. Plebani and E. Piva: “Erythrocyte Sedimentation Rate”, American Journal of Clinical Pathology, Vol. 117, 2002

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

(4) NCCLS “Reference and Selected procedure for the Erythrocyte Sedimentation rate (ESR) Test; Approved Standard-

Fourth Edition”, Vol. 20 No. 27

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

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

(7) Ajubi et al.: “Determination of the lenght of sedimentation reaction in blood using the TEST 1 system: comparison

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

(8) Mercurio S. et al.: “Confronto tra due metodi per la determinazione della VES in pazienti con mieloma”, 37° Congresso

Nazionale SIBioC, 11-14 ottobre 2005 Roma

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3- WARNINGS FOR A CORRECT USE OF THE INSTRUMENT

The following safety instructions must be observed at all times, both before and during operation and during maintenance.

Handling of Instructions for use Manual the instructions for use manual is provided for your safety and gives important instructions for the handling of the system described. • Read all instructions! • Keep the instructions for use manual nearby the system. • he instructions for use manual must be accessible to the user at any time. TEST1 system is designed and manufactured in accordance with the safety requirements for electronic and medical systems. If the law issues regulations concerning the installation and/or operation of the instrument, then it is the operator's responsibility to adhere to them. The manufacturer have done everything possible to guarantee that the equipment functions safely, both electrically and mechanically. The systems are tested by the manufacturer and supplied in a condition that allows safe and reliable operation.

GENERAL SAFETY

Non-Observance of Warnings The non-observance of warnings can result in serious personal injury and material damages.

• Follow all warnings included in this manual. • Follow all warnings marked on the instrument. • 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.

Use of the System according to Intended Use only

� Improper use of the instrument, not in compliance with the manufacturer specifications, could lead protection impairment and damages to both operator and/or instrument as well as can result in wrong results, damage of the system and personal injury.

• The handling and maintenance of the system must only be performed by trained and authorized personnel.

• Before the operation of the system, the Instruction for use manual must have been read and understood.

• The instrument must only be used in accordance with its intended use. • The instrument is designed for indoor uses only. • For professional in vitro medical diagnostic use only. The English language

knowledge is required in those countries where neither Italian nor French nor Spanish nor German is spoken.

• Use only the consumables and accessories described herein • Keep away any kind of objects, liquids, or substances not required for the

instrument’s use from the instrument. • The manufacturer assumes no liability for any damages, including those to third

parties, caused by improper use or handling of the system, 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 out if required.

• This instrument is not intended for use by persons with reduced physical, mental and sensorial capabilities or lack of experience and knowledge,

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Rev.1.2 – 2015.10.10


unless they have been given supervision or preliminary instructions for the use of the analyzer by a person responsible for their safety.

� IN CASE UNAUTHORIZED SOFTWARE IS INSTALLED ON THE INSTRUMENT, THIS

MIGHT GENERATE MALFUNCTIONING OF THE INSTRUMENT AND/OR EVENTUALLY UNRELIABLE ANALYTICAL RESULTS; FURTHERMORE INSTALLING UNAUTHORIZED SOFTWARE INVALIDATE THE WARRANTY OF THE INSTRUMENT.

OPERATIVE SAFETY Mobile Phones Do not use a mobile phone next to a running system. It is possible to affect the correct function of the system. Instrument use in routine

• Switch to ON the instrument and wait at least 20 minutes before its use to reach the appropriate temperature inside the instrument and the thermal stabilization of the electronic circuitry.

• Before starting a new session, the instrument visualizes a control check-list, is mandatory to verify all check that all the parameters in the check-list are as expected, otherwise contact the Technical Service

• For professional in vitro medical diagnostic use only. The English language knowledge is required in those countries where neither Italian nor French nor Spanish nor German is spoken.

• Check the waste tank level before starting the measures. Empty or replace it, if filled to security level; for the disposal of waste tank content, follow the standard safety procedures in use in the laboratory.

• Carry-out appropriate "WASHING PROCEDURES" to a good instrument maintenance • Keep away any kind of objects, liquids, or substances not required for the instrument’s

use from the instrument. • Check if the tube contains at least 1 ml of blood and verify that the blood is not neither

haemolysed nor coagulated. Use exclusively blood samples withdrawn in EDTA anticoagulant (K2 or K3).

• Use preferably tubes with a capacity of 3 ml verifying that the sample volume should not exceed the 50-60% of the total volume of the test-tube in order to optimise the blood homogenization and consequently the results reproducibility.

• In the event customer uses collecting tubes with 4ml capacity, it is possible to obtain good correlation with the method used into the laboratory with the following tips: 1. Using the gain of the instrument during correlation with lab reference method 2. Increasing the mixing time (this can be obtained using an external mixer before the ESR

analysis or/and increasing the mixing time of the ESR analyzer). 3. If the CBC has the venting function, possibly execute first the CBC analysis and then the

ESR analysis.

• Start the analysis within 2-4 hours from vein-puncture, 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 their analysis.

• Do not pour liquids or leave to fall anything inside the fridge and thermostat units. In such case, switch OFF IMMEDIATELY the instrument and call the Technical Service. Do not try to remove any object, even if visible, when the unit is switched ON.

• In case of a vial is broken inside the instrument, it is mandatory to call the Technical Service

• An acoustic signal will be activated when the loading door remains opened. Close the door to allow the system to progress with the analysis.

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MECHANICAL SAFETY

Danger of Electrocution or Mechanical Injury by Missing or Opened Protective Covers To avoid serious injury with lethal consequences due to electrocution or injury by the system (e.g. contusion, cuts etc.), protective covers must not be opened or removed by no reason by user; only authorized Technical Service Engineers or manufacturer Engineers can remove protective covers.

• Do not remove the panels neither camper the reading sensor. • The internal carriage moves over a sliding guide which is an “auto lubricating”

guide, so it is not necessary to lubricate or add any kind of oil or grease along the rails of the carriage guides.

• Switch off the system, separate it from the mains supply and protect it against restarting.

• For your safety, if any part should be damaged, ask for the immediate replacing with original spare parts, specially for the parts connected to mains (power cord, fuse-holder and mains switch …)

• It is very important to check the tube’s height because: - TEST1 BCL, SDL, YDL, MDL and XDL cannot use tubes with a height over

than 83 mm (cap included). - TEST1 THL: Can use tubes up to 95 mm (cap included) but working with

only 15 samples Alifax rack (code SI19550003). • 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.

• Use only original spare parts supplied by the manufacturer. • Use only peripherals authorized by the Manufacturer

Maintenance must be carried out only by qualified Technical Engineers authorized by the manufacturer

• Use only original spare parts supplied by the manufacturer. • Use only peripherals authorized by the Manufacturer • Make sure that nobody works on the system and that all covers are attached and

closed before you reconnect the system to the mains supply. • Perform maintenance works with highest caution. • Only perform maintenance works described in this manual. • The unit shall be inspected and maintained each 30 000 analyses.

ELECTRICAL SAFETY

Electrocution/Fire Hazard! Non-observance of rules and regulations can cause serious personal injury with lethal consequences and material damage. National rules and legal regulations for the safe electrical operation of the system must be observed. During Installation please be sure

• Avoid improper connection of the system and the peripheral devices to mains supply can cause serious personal injury with lethal consequences and material damage (e.g. fire).

• Use only connection and extension cables with a protective conductor and sufficient capacity (performance, power) to connect the system and the peripheral devices to the mains supply.

• Never interrupt the grounding contacts. • Grounding of the system and its peripheral devices to the same protective earth

potential must be ensured and it is connected to a mains socket with a Protective Earth terminal before its use

• The use of a multi plug is not allowed!

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• Use a Smart Ups with at least 1500 VA capacity. • Damaged connecting cables can cause serious personal injury with lethal

consequences. Damaged connecting cables must be replaced immediately! • No objects may be placed on the connecting cables. • Connecting cables must be laid so that they cannot be squeezed or damaged. • Connecting cables must be laid so that they do not lay in accessible or drivable

areas. • Switch OFF the instrument before connecting any external peripheral as external

bar code readers, printer cables and/or RS232 serial cables

Danger due to Improper Place of Installation Improper place of installation of the system can cause accidents with serious injuries with lethal consequences, fire or serious system damages because the system cannot be switched off or be separated from the mains supply.

• Ensure the place of installation of the system is so that the power supply and mains switch are easily accessible.

• 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 manufacturer does not assume any responsibility for eventual damages to persons or things due to improper, installation not in compliance with the manufacturer's specifications.

Electrocution/Fire Hazard! During the normal routine working please:

• Keep away any kind of objects, liquids, or substances not required for the instrument’s use.

• Do not pour liquids or leave to fall anything inside the fridge and thermostat units. In such case, switch OFF IMMEDIATELY the instrument and call the Technical Service. Do not try to remove any object, even if visible, when the unit is switched ON.

Electrocution/Fire Hazard! During Maintenance/ Technical Service activities be sure to:

• Immediately separate the defective system from the mains supply, if a safe usage is no longer possible.

• Secure the defective system against reconnection. • Label the defective system clearly as being defective.

Battery Handling The product may contain an internal lithium manganese dioxide, vanadium pentoxide, or alkaline battery or battery pack. There is risk of fire and burns if the battery pack is not handled properly. To reduce the risk of personal injury:

• Do not attempt to recharge the battery. • Do not expose to temperatures higher than 60°C (140°F). • Do not disassemble, crush, puncture, short external contacts, or dispose of in fire

or water. • Risk of explosion if battery is replaced by an incorrect type. Dispose of used

batteries according to the instructions. • Replace only with the spare designated for this product. • Battery for PC Motherboard Lithium battery is BR2032 3 V. • Battery for computer S195.001C in left drawer is Wentronic #23323 BH170-3P;

Ni MH; 3,6V 230 mAh.

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Transient Emissions and Interference Resistance The instrument meets the requirements described in standard IEC 61326 and IEC61326-2 on transient emissions and interference resistance.

• This instrument can cause radio interference in domestic environment. In this case it may be required to take action to eliminate such interference.

• Before setup and operation of the instrument, the electromagnetic environment should be evaluated.

• Do not use the instrument in the vicinity of sources with excessive electromagnetic radiation (e.g. unshielded, deliberately operated high frequency sources) since they could interfere with the proper operation of the instrument

• 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.

• Avoid the use of the instrument near electromagnetic sources like for example cellular phones, CB’s, radio transmitting units and similar

• This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference

BIOLOLGICAL SAFETY

Risk of infection!

� The instrument, can be exposed to potentially infective materials; system therefore must be treated as being potentially infectious, is thus indispensable to adopt all the precautions and warnings necessary apt to avoid the contact (mandatory the use of gloves and glasses during vial manipulation) in accordance with national laws.

Improper handling of infectious parts can cause skin irritations, illnesses and possibly to death.

• Use appropriate gloves! • Use an appropriate lab coat! • Avoid contact between skin/mucous membrane and samples/test reagents or

parts of the instrument. • Clean, disinfect and decontaminate the system immediately if potentially infectious

material has been spilled. • Do not use broken or chipped tubes or bottles. • Observe the instructions in the package inserts for a correct use of the reagents.

Waste and Disposable procedures

• Observe local and national provisions, legislation and laboratory regulations. • Observe the legal regulations for the handling of infectious material. • Dispose used vials, following the standard safety procedures in use in the

laboratory.

Maintenance

During Maintenance/ Technical Service activities be sure to:

• use gloves to protect agains any possible accidental contact with infectious materials presents inside instrument .

• if during maintenance the instrument has been stored /moved to a cold places, wait at least 30 minutes before switching ON again the instrument for the first time in order to avoid eventual damages due to dew presence on internal parts of the instrument.

• It is mandatory to do the sanitization (use gloves and protective glasses) and locking drawers procedure before maintenance or before send back to the manufacturer

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LASER SAFETY

Eye Injury due to Laser Radiation Laser radiation cause eye irritations if you look into the laser beam for a longer period of time. TEST1 has a laser mounted inside the incubator plate.

• THIS PRODUCT CONTAINS A LASER CLASS 1 B (IEC 60825-1) LASER PRODUCT. DO NOT REMOVE THE PROTECTIVE PLASTIC OR METALLIC COVERS DURING OPERATION OF INSTRUMENT.

• Do not look at the laser beam directly or through lenses when the laser diode is activated.

• The laser beam emitted by laser diode is harmful if aimed directly into human eye.

• If during Technical Maintenance, if it is necessary to work near the laser zone, it is mandatory to wear protective glasses or googles designed to protect eyes against LASER CLASS 1 B light (IEC 60825-1).

• Maintenance must be carried out ONLY by technicians certified and authorized by Alifax. Maintenance done by non-authorized technicians could cause severe damages inside the instrument and affect the reliability and the safety of the instrument.

• Never look directly into the laser beam! • Do not use optical devices. • Take off watches and mirroring jeweler before operating the laser. • Please note that the wrong usage of operating elements or of adjustments or the

non-observance of processes can cause a dangerous emission of laser radiation.

TEST1 SAFETY LABELS AND TYPE LABELS

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

CAUTION!

TO PREVENT ELECTRIC SHOCK

DISCONNECT POWER CORD

ATTENZIONE!

PER PREVENIRE SCARICHE

ELETTRICHE SCOLLEGARE

IL CAVO DI ALIMENTAZIONE

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PROCEDURE OF INSTRUMENT WASTE AT THE END OF ITS OPERATIONAL LIFE

As stated in the European directive 2002/ 96/CE related on waste of electrical and electronic equipment (WEEE), appropriate measures should be adopted to minimize the disposal of the instrument as unsorted municipal waste and to achieve a high level of separate collection of WEEE, according to the applicable local laws and rules. The crossed-out wheeled bin symbol on side, placed also close to the plate of the apparatus, points out the necessity of the separate collection of the electrical and electronic equipment (WEEE). The separate collection of this instrument at the end of its life is organized and managed by your distributor. The user who is going to get rid of it will therefore contact his distributor and follow the system that he has adopted in order to dispose the separate collection of the equipment that has reached the end of its working life. The unauthorized disposal will be pursued according to the local laws and the rules in the nation of use. Fines will be effective, proportionate and dissuasive.

4- UNPACKING AND INSTALLATION

Please refer to Service manual chapter 4.

5- INSTRUMENT DESCRIPTION and start-up

Please refer to Service manual chapter 5.

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6- VOLTAGE SELECTOR AND FUSES REPLACEMENT

Before turning the instrument on for the first time, it is necessary verifying the voltage selector position (from factory is set to 230 Vac). Locate the voltage selector on the rear side of the instrument, as displayed on the

photo, then using a small flat screwdriver, rotate the selector toward right to set it to 115 Vac.

On the Main Switch block are located 2 fuses, which are easily accessible to be

replaced. To replace the fuses use the following procedure: • Locate the fuses box • Using a flat screwdriver push down the small tongue that keeps the box inside

the switch block and pull it out using a small pliers (if necessary). • Remove completely the fuse box

• Replace BOTH fuses (*)

• Then insert again the fuse box

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

box’s tongue fits on the hook (*) The fuse which is placed in appliance inlet shall be replaced only by a T5,0 A L 250 V dimensions 5x20 mm . A T5,0 Ampere fuse; it is suitable for both 115 and 230 Vac.

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7- KEYBOARD SPECIAL FUNCTIONS

Each keyboard key reports not only the numerical value but also the function can be activated pressing that key. It should be understood that such options are intended when the instrument is standing on “MAIN MENU”

The keys are:

0 - Availability Increase (to increase the availability of test)

1 - Rack Insertion (to insert the rack into the instrument)

2 - Washing (to start a washing procedure)

3 - Rack Removal (to remove any rack from the instrument)

4 - Date & Time (to modify date and time)

5 - Tech. Menu (to access Technical Menu)

6 - Calibrat. Std (to start a control process)

7 - RX Data Waiting (used only in absence of both internal and external scanner)

8 - Operat. Menu (to activate the list printing or the mixing without performing any analysis)

9 - Tank Replace (to reset the wasted liquid counter)

REPRINT - (to activate the Statistical Data printing)

PAPER FEED (to activate the paper feed)

CLEAR - (to replace the needle)

Photo 1

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8- SWITCH ON THE INSTRUMENT

Verify whether the front door is closed, than turn the instrument on pressing the rear-side switch. Wait at least 20 minutes before starting the analysis to allow the temperature reaching the 37°C and getting its stability. At the beginning of the instrument working life, it is important checking whether the configuration of the racks is right (it is printed out on the first printing) in order to avoid mechanic and syringe group damaging. When activated, the instrument is going to print out like :

TEST1

UK ver. 6.51X This identifies the installed SW version. TEST1 SN. xxx Serial Number of the instrument DD/MM/YYYY HH:MM Date & Time

======================= Bar code inside:DS1100 An internal Bar-Code Reader is detected Mixing speed 2 Mixing speed

Rack label 1 xxxxxxxx � �

Rack label 2 xxxxxxxx � �

Rack label 3 xxxxxxxx � � R1 On R2 On R3 On R4 On Rack Rack enabled for the functioning. AVAILABILITY ESR 200 warning (<1000) Credits availability to carry out ESR analysis and threshold indication

(operative only if the credits amount is below the set threshold).

======================= Press 8 for menu ======================= TEMP. 37,0

9- TANK EMPTYING / REPLACING

Warning!! A SW function calculates the volume of blood wasted into the waste tank after analysis. A counter is going to increase after each processed sample and the number of analysis that can be processed before activating the waste tank alarm is set to 1500.

When the alarm threshold is reached, the following message is going to be printout on paper:

================ Waste Level detected ================ EMPTY the tank. ================

At the same time the display is going to show this message:

0 - NOT EMPTY 1 - EMPTY

At this point and after opening the front flap, it is mandatory emptying or replacing the waste tank. Key "1" (EMPTY) is to reset the wasted samples counter to 0. Key 0 (NOT EMPTY) instead allows the instrument going on counting for the further discarded tests. The reset process can also be recalled manually pressing key 9 - Tank Replace on MAIN MENU and then 9.

Note: For the disposal of the waste tank content, follow the standard safety procedures in use in the laboratory.

During printing, the instrument gives out two acoustic beeps. Then it is going to proceed with the initialization phase moving all mechanical parts. After that, the printer is going on print out messages like those reported on the left example.

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10- MAIN MENU OPTIONS

Pressing key 8 (Operat. Menu), the display is going to show the following message: Pressing Key 1 it is possible to print-out the list of the functions assigned to each key:

Pressing key 2, the instrument is going to activate the mixing of samples. It will be done without doing 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 rotation at each 30 seconds up to the pressure of ENTER key.

11- CHANGE DATE & TIME

To change Date & Time, press key 4 on MAIN MENU. The LCD display will show this message:

DD/MM/YYYY setup DATE

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

If date is correct press ENTER key to confirm. Unlikely if the date needs to be changed, press CLEAR and type the correct date. For the year, only the last two digits can be changed.

At this point the displayed message is:

HH:MM setup TIME

where HH=hour, MM=minutes

If time is correct, then, press ENTER. Unlikely if the time needs to be changed, press CLEAR and type the correct one.

1 - Menu printing 2 - Mixing

0 - AVAILABILITY

1 - MEASURE

2 - WASHING

3 - RACKS EXTRACTION

4 - DATE & TIME

5 - TECHNICAL MENU

6 - CALIBRATION EC

7 - RS232 RX DATA

9 - TO CHANGE TANK

REP - STATISTICAL DATA

CLEAR - NEEDLE REPLACING

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12- PROCEDURE FOR PAPER LOADING INTO THE PRINTER

The described procedure has to be done at instrument ON.

1- Open the cover of the printer set above the keyboard and remove the residual part of paper. If the printer model is “CUSTOM PLUS” then to open the cover force the two lateral clips which retain it. If the printer model is “CUSTOM PLUS II” then to open the cover press the green central key.

2- Pull-out roughly 15cm of paper from the roll, remove the part stuck on paper and be sure that the paper stream descends from the bottom side of the roll.

3- Place the new roll into the printer lodgement with the paper border out from the printer.

4- Close the cover pressing it deeply until the two retaining clips are locked to the printer.

5- Press PAPER FEED on keypad or on the printer to obtain more paper if it is necessary.

Note:

If the paper roll is sold with the code 195.800, its exhaustion is indicated by a red colour line painted on the last part of the strip. Please remember that from the initial appearance of colour the strip can guarantee the printing of 60 samples and therefore it is suggested to replace the roll immediately after finishing the analysis cycle or before starting a new one.

Photo 2 CUSTOM PLUS

Photo 3 CUSTOM PLUS II

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13- AVAILABILITY TEST INCREASING

The instrument works with credits of test which can be loaded by means of Smart Card ALIFAX supply. The amount of credits the customer can require is between 1000, 4000, 10000, 20000. By this software version, the Smart Card and process to load credits are managed by the instrument which includes options printed-out on paper during the loading process activation.

If, on MAIN MENU, key 0 is pressed, the printer will be able to print-out a menu as reported below:

To increase credits by ordinary Smart Card, press key 1, insert the card into the reader slot and then press ENTER when “SM FST AREA OK” (the instrument’s personalization has been matched to the card personalization) is displayed. The printer is going to print-out messages like those reported on the right. Remove the Card and press ENTER. To check the card press 2. The instrument displays the request to insert the card into the slot. Insert the card and wait. The display will show information according to the Smart Card status. It could be :

To get the SMART CARD LOG press 3. The printer is going to print-out the history of all loadings been executed; e. g: Note: When Rack insertion (key1) is pressed and the present availability is between 0 and 1000, the procedure to increase the availability will be recalled automatically. If the availability is 0 or negative, the instrument will not allow the execution of new analysis until new credits will be loaded.

…...if the card is already used. Remove the card and press ENTER while the printer is going to print-out the message like the one set on the right..

……if the card is unused. Remove the card and press ENTER while the printer is going to print-out the message like the one set on the right.

1 – increase AVAIL.

2 – smart status

3 – print log smart

Used Card Press ENTER

Not used Card Press ENTER

Used card Sn 0 Contain xxxxxx tests Download date 31/03/2010

Not used card Sn 0 Contain xxxxxx tests Manufacturing year 2000

----------LOG SMART CARD---------- Date Aut I Card Aut. A Sn Year 31/03/10 1995 1000 2995 0 2000 25/03/10 200 1000 1200 0 2000 31/03/10 1000 10000 11000 0 2000

AVAILABILITY

ESR 1995

New personalization

ALIFAX S.r.l.

SMVALUE 1000

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14- UNIVERSAL CARD

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

15- SMART CARD ERRORS

During the loading process, incorrect procedures or possible malfunctions can be caused by:

1. the smart card not inserted properly or inserted upside-down

2. the card contact plaque not set to the internal side of the instrument.

3. The reader contacts don’t allow the card to be read.

Error messages could appear on display like:

it means the card has a number of tests that is outside the normal ranges: 1000 – 4000 – 10000 – 20000

it means the inserted card has a personalization that doesn’t match the instrument personalization and so the instrument rejects that card.

OUT STD XXXX

Press ENTER

SM FST AREA NOK

Press ENTER

Photo 4 Universal Smart Card

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16- RACK CONFIGURATION

This software version is able to manage different kind of racks which can be loaded into the instrument directly, assuming the instrument is equipped by a direct insertion kit and internal Scanner (IBCR), or using adapter designed for TEST1THL.

TEST1 XDL (see to Photo 5):

TEST1XDL is developed to accept Coulter DXH-800 cassette which carries 5 positions. Can be load 2 cassettes in each direct insertion support to a total of 8. This model is even supplied with the internal bar code reader (IBCR) already configured.

Immediately after turning the instrument on, a first printing reports the kind of rack stored in the software E.g.

Rack label 1 XDL DI � � label 1 is assigned to COULTER DXH-800 cassette.



For any incongruence, contact the technical service.

TEST1 YDL (see to Photo 6):

TEST1YDL is developed to accept Bayer/Siemens the ADVIA-120 cassette which carries 10 positions. This model is even supplied with the internal bar code reader (IBCR) already configured.

Immediately after turning the instrument on, a first printing reports the kind of rack stored in the software E.g.

Rack label 1 BAYER DI � � label 1 is assigned to Bayer/Siemens cassette




TEST1 MDL (see to Photo 7):

TEST1MDL is developed to accept Beckman Coulter LH 500 SERIES (Max-M) cassettes. Can be load 2 cassettes in each direct insertion support to a total of 8. This model is even supplied with the internal bar code reader (IBCR) already configured.

Immediately after turning the instrument on a first printing reports the kind of rack stored in the software E.g.

Rack label 1 MAX-M DI � � label 1 is assigned to Beckman Coulter Max-M (LH500 series) cassettes




TEST1 SDL (see to Photo 8):

TEST1SDL is developed to accept Sysmex SF/SE/XE cassettes which carries 10 positions. This model is even supplied with the internal bar code reader (IBCR) already configured.


Rack label 1 SYSMEX DI � � label 1 is assigned to Sysmex cassettes




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TEST1 BCL (see to Photo 9 Photo 10):

TEST1 BCL is developed to accept Beckman Coulter LH700 SERIES cassettes which carry 12 positions and ALIFAX plastics green racks which carry 15 positions. This model is even supplied with the internal bar code reader (IBCR) already configured.


Rack label 1 COULTER D � � label 1 is assigned to Beckman Coulter / Alifax green cassette




Photo 5 TEST1-XDL

Photo 6 TEST1-YDL

Photo 7 TEST1-MDL

Photo 8 TEST1-SDL

Photo 9 TEST1-BCL

Photo 10 TEST1-BCL

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TEST1 THL:

TEST1THL model works with different kind of racks too but it is requires an appropriate adapter for each kind of them.

TEST1 RACK (does not require any adapter)

ADAPTER FOR ABBOTT CELL Dyn 3500-3700 / SYSMEX sf-se-xe RACK

ADAPTER FOR ABX Pentra 120 RACK

Photo 14

COULTER H ADAPTER FOR COULTER LH700 RACK

Photo 15 COULTER M ADAPTER FOR COULTER LH500 RACK

Photo 16 ADAPTER FOR ABBOTT CELL Dyn 3200-4000 (Abbott Long)

Photo 17 BAYER ADAPTER FOR Bayer Advia 120 RACK

Photo 18

COULTER RT ADAPTER FOR COULTER LH700 RACK

Note: Details for rack management for TEST1THL are available on page “ 57 APPENDIX A”.

Photo 11 Photo 12 Photo 13

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17- USE OF PAEDRIATIC TEST-TUBE

The insertion of pediatric test-tube in the rack, requires the use of adapter. Such adapter is not universal but designed in three different measures for SARSTEDT (Photo 19) TAPVAL (Photo 20) VACUTAINER (Photo 21) The sale codes of the adapters are: SI195595 (adapter for SARSTEDT test-tube) SI195590 (adapter for TAPVAL test-tube) SI195593 (adapter for VACUTAINER test-tube)

Note: Other kind of paediatric test-tube cannot be used because of lack of adapter.

Photo 19 Photo 20 Photo 21

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18- STARTING ANALYSIS SESSION

PROGRAMMING TEST1 WITH AUTOMATIC ID’s (for TEST1 THL only)

If TEST1THL has been equipped with an internal scanner, the patient identification code (ID) will be read automatically during the analysis cycle. The analysis enabling of each specimen is decided by host computer whereas the analyser is linked with it through serial connection. Press key 1(Rack Insertion) to run the analysis cycle and wait until the following message is displayed .

Open the front door, remove any rack that might be still inserted and put-on the rack with the samples to analyse. Close the front door.

It will follow the below message

If the display is going to display the message like:

… or: …then follow the indication described at point 8 on page 39 (Note for the analysis cycle and washings).

PATIENT IDENTICY CODES READING BY MEANS OF EXTERNAL BAR CODE READER (on TEST1THL only)

Introduction: This procedure can be used only on TEST1THL and whether the analyser has not been equipped with internal barcode reader/scanner (IBCR). If the ESR results have to be matched with the patients ID code, the analyser has to be equipped with an external barcode reader/scanner (EBCR) connected at SERIAL PORT 1 (upper serial-port) set on the instrument rear side. After filling the rack with test tubes containing blood specimens and before reading the patient identity code (ID) the rack has to be OPEN reading a particular code on label applied on each adapter rear side (C001). After this, it will be possible to read the identity code (ID) of each specimen up to the 15

th (they will be displayed one by one). If the code read by the reader doesn’t correspond to the

displayed ID, pressing CLEAR key, present on the TEST1 keyboard, it is possible to erase the incorrect ID and reading it again. At the end of the patient identity code reading (ID) the rack has to be CLOSED reading the code again as described below.

To activate this procedure press key 1 (Rack Insertion). The following message is going to be displayed:

Reading the special label “C001”, the yellow central led, set under the LCD display, is going to be lighted and the following message displayed:

This means rack 01, identity code in reading 00

If other racks have to be inserted on the same analytical cycle, repeat the steps described before. On the contrary press START to run mixing followed by the analysis process.

Insert rack, or

START to measure

Insert rack

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Insert rack

01 00

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TEST1

Rev.1.2 – 2015.10.10


Read the first barcode label by the EBCR so that the following message will be displayed:

This means rack 01 and the 1st

identity code in reading. Xxxxxxxxx is the patient Identification number

Reads the successive ID codes (max 15) and at the end of the rack, read again the code “C001” to close the rack. This is confirmed by the yellow led off.

Then the display will appear:

Open the front door, remove any rack still present and load the rack containing the specimens to analyse. Close the door.

It will follow the below message:


… or: …then follow the indication described at point 8 on page 39 (Note for the analysis cycle and washings).

If START is pressed, the analytical cycle will be run, otherwise reading the code “C001” again, a new rack will be open again to run a new programming procedure. This procedure can be repeated for inserting successive racks (max 4). Note:

1. If during readings, one ID code has not been read correctly, pressing CLEAR the inserted code could be erased and therefore that ID code could be read again. Pressing ENTER, instead, it is possible to replace or generate one ID code by a univocal code of 6 characters: it will be formed by 2 characters that identify the cycle number, 2 characters that identify the number of rack and two characters that identify the sample position in the rack.

2. Follow the indication described on page 39 (Note for the analysis cycle and washings).

If other racks have to be inserted in the same analysis cycle, repeat the operation described previously. Otherwise press START to run mixing and the analysis process.

01 01

xxxxxxxxxx

Insert rack

other rack or

press START

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Rev.1.2 – 2015.10.10


PATIENT ID INTRODUCED BY KEYBOARD AND CORRECTION (for TEST1 THL only)

This procedure will be disabled, if in the instrument there is installed an Internal Bar Code Reader and recognised by the analyser.

To activate this procedure press RX Data Waiting (7) key. The following message will be displayed:

Wait RX data START to measure

Open the front door, the yellow central LED under the LCD display will light.

The following message is displayed:

insert ID 1 - 01

(the code 1 - 01 corresponds to the rack #1 and sample #1)

Type the entered patient identity code. It will be displayed as on the example below:

Digitate ID 1 - 01 89012791

(the 89012791 is the patient Identification number)

Press ENTER and type the further patient identity codes. Some other messages will be displayed as :

Digitate ID 1 - 04 89012797

(the code 1 - 04 corresponds to the rack # 1 and sample # 4) (the 89012797 is the fourth patient Identification number read)

When the ID code of all samples of the first rack are read, close the front door to close the rack. The dark yellow led points out that the rack closed while the following message is displayed:

wait RX data START to measure

If there are other racks to insert (maximum 4), open the front door and repeat the procedure.

When the above message appears and at least one rack is programmed, it is possible to activate, if necessary, a check / correction procedure of the inserted ID codes:

• To see the number of codes set in each rack, Key “1” activates the list printout as the following example: RACK 01 15 RACK 02 00 RACK 03 00 RACK 04 00

• To see all codes typed in each rack, key “2” activates the list printout as the following example:

RACK 01 15 1……2345678 2……3245679 3……5532535 4……35353… 5………… …….. 15 2543789

RACK 02 02 1……2343434 2……3245454

RACK 03 00 RACK 04 00

In this example, the list points out that there is only the first rack programmed with 15 patients ID codes.

In this example, the list points out that there is the first rack programmed with 15 patients ID codes and the second programmed with 2 patients ID codes. All codes of the respective racks are printed out.

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TEST1

Rev.1.2 – 2015.10.10


By pressing PAUSE(↓) or REPRINT(↑) , it is possible to scroll up and down to all IDs of all programmed racks. When the ID to correct is displayed, press CLEAR to delete it and typed, the correct one confirming with ENTER.

The same procedure can be activated even if the TEST1 programming process is done via RS232 by automatic data exchange.

When the programming and correction is done, the “START” key is going to activate the measuring process. Pressing START, the following message is displayed:

insert rack

Open the front door, remove any rack if present yet, insert the rack with the samples to process and close the door. The following message is displayed:

other rack, or START to measure

If other racks have to be inserted in the same analytical cycle, repeat the described step, or press START to start the analysis. Four racks at maximum can be inserted together. In this case, after the insertion of the fourth rack the analysis starts automatically. Note: The analytical cycle cannot be interrupted for insertion of further racks. When the analytical cycle starts the following message is displayed:

MIXING

Warning!! For instruments TEST1 THL the tubes must be lodged and locked tightly into the rack, then insert the rack into the slide to the end.

Note: follow the indication described on page 39.(Note for the analysis cycle and washings).

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TEST1

Rev.1.2 – 2015.10.10


ANALYTICAL CYCLE ON ANALYSERS EQUIPPED BY DIRECT INSERTION KIT

General caution valid for all “DI configurations”: Before inserting the rack in the instrument, be careful to check that all tubes have their bar code label turned to the right side of the rack. The internal bar code reader (IBCR) therefore will not read the label. In this new model, it is possible to leave empty places, even consecutively. In any case the instrument will perform (if required) the ESR without aborting the cycle (as before).

To insert samples tubes into the rack, with the labels properly oriented.

The tubes must be inserted sequentially and it is allowed to leave some free location among them, starting from position 1. The rack can be inserted into the TEST1 even if loaded with only one sample tube. After pressing Rack Insertion (1) wait until the following message is displayed:

Open the front door, remove any rack that might be still inserted and put-on the rack with the specimens to analyse. Close the front door.

It will follow the below message


… or: …then follow the indication described at point 8 on Page 39.(Note for the analysis cycle and washings).

The following photos, explain how to load the samples (depending the type of Direct Insertion configuration):

TEST 1 XDL

Open the loading door (Photo 22), press the guide until it is unhooked (Photo 23), pull out it until it is extracted completely (Photo 24). Insert the cassette in the guide (Photo 25) and rotate the test-tubes that don't allow the complete exposure of the bar codes labels then slide the guide inside the instrument. Push it up until the guide is hooked and close the sliding door.

Photo 22

Photo 23

Photo 24

Photo 25

If other racks have to be inserted on the same analytical cycle, repeat the steps described before. On the contrary press START to run mixing and the analysis process.

Insert rack

other rack, or

press START

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Rev.1.2 – 2015.10.10


TEST 1 YDL

Open the loading door (Photo 26), press the guide until it is unhooked (Photo 27), pull out it until it is extracted completely (Photo 28). Push toward right side the lever to rotate the sliding guide in order to allow the cassette entering over the guide (Photo 29). Release the lever and check the cassette fits correctly inside the sliding guide, rotate eventually the test-tubes that don't allow the complete exposure of the bar codes labels then slide the guide inside the instrument. Push it up until the guide is hooked and close the sliding door.

Photo 26 Photo 27 Photo 28 Photo 29

TEST 1 MDL:

Open the loading door (Photo 30), press the guide until it is unhooked (Photo 31), pull out it until it is extracted completely (Photo 32). Insert the racks as indicated by the Photo 33 and then fix them pushing gently from the two extreme sides to lift the test-tubes and allow their complete exposure of the bar codes. Rotate eventually the test-tubes that don't allow the complete exposure of the bar codes labels. Slide in the guide, push it up until feel hooked and close the sliding door.


TEST 1 SDL:

Open the loading door (Photo 34), press the guide until it is unhooked (Photo 35) pull out it until it is extracted completely (Photo 36). Push toward right side the lever to rotate the sliding guide (Photo 37) in order to allow the cassette entering over the guide (Photo 38). Release the lever and check if the cassette fits correctly inside the sliding guide. Rotate eventually the test-tubes that don't allow the complete exposure of the bar codes labels then slide the guide inside the instrument (Photo 39). Push it up until it is hooked and close the sliding door.


Photo 38 Photo 39

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TEST1

Rev.1.2 – 2015.10.10


TEST 1 BCL:

Open the loading door (Photo 40), press the guide until it is unhooked (Photo 41). Accompany it up for the complete extraction (Photo 42) and insert the rack toward the inside position. Press then it on two extreme sides for lifting the test-tubes (Photo 43) and allow the complete exposure of their bar codes. Rotate ant test-tubes that don't allow the complete exposure of the bar codes labels. Slide in the guide, push it up until it is hooked and close the sliding door.

Photo 40

Photo 41

Photo 42

Photo 43

Note:

1) If the label is unreadable or not properly oriented, the TEST1 will assign an identification number automatically that represents the cycle number, the serial number of TEST1, the rack number (1÷4) and the position of tube in the rack (1÷15).

Example: 0007027501 5 0007014639 18 0007024687 2 0102530104 35 identification number not detected (01 for first cycle, 0253 for TEST1 sn. 253

01 for rack 01 and 04 for sample position 04 on rack). 0007024633 78

2) Follow the indication described on page 39.(Note for the analysis cycle and washings).

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TEST1

Rev.1.2 – 2015.10.10


ANALYSIS CYCLE

At the middle of mixing and only if the capillary has been washed previously, the instrument is going to withdraw a blood aliquot from the first and from the second test-tube put into position one and two of the inserted first rack. If there is only one test-tube inserted, the system then, is going to aspirate the same aliquot of blood twice from the first test-tube. The two aliquots of blood, then, will be moved forward and backward into the capillary for a few times in order to remove any residual particle of water from the Teflon capillary. This procedure is named “priming”. The two segments, then, will be wasted into the waste tank and then the instrument is going to continue the mixing process of the specimens to complete their homogenization. Afterwards the system is going to aspirate the suitable amount of blood, according to host computer decision if connected in Query Host way, to carry-out the analysis. The printer, if it has been enabled, then, will print-out the ESR analysis result of the present specimen and the successive ones whereas the analysis has been required. They will be printed-out by the following format at 20 seconds intervals.

Graph meaning:

The RACK field points-out the number of rack (1-4) and the position of the sample (1-x) where x depends on the capacity of the rack. Analysis date & time. ID of the patient: read by scanner (IBCR) or auto generated.

A ESR result like “< 2” occurs when the real value is lower than 2mm/h as it is the minimum value of the reading scale. The instrument filters it to 2.

A ESR result followed by an asterisk (*) occurs when the analyzed sample has a low level of hematocrit ( ~ 20%).

N.F. = No Flow occurs when there was no blood or air bubble into the capillary at the reading time. (*Note) A ESR result like “>120” occurs when the real value is higher than 120mm/h as it is the minimum value of the reading scale. The instrument filters it to 120.

Other kind of results could be N.R. which means not reliable. This occurs when the ESR result is far out of range or not detectable because of strange morphology of the blood. The analysis repetition of that specimen should help in solving the problem as to the specimen is mixed twice. *Note:

� In case of three consecutive N.F.s the analysis cycle stops working and a washing procedure will be required. A possible needle or capillary obstruction could be removed and the analysis could be rerun again.

� In order to print-out the arrow (<>) next by an extreme value (2 – 120) in the ESR range, the technician in charge to carry-out maintenance has to enable this function by request.

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TEST1

Rev.1.2 – 2015.10.10


END OF CYCLE

At the end of analysis cycle the message displayed is:

Pressing ENTER, the cycle is going to end and it will go back to MAIN MENU.


… or: …then follow the indication described at point 8 on page 39.(Note for the analysis cycle and washings).

RESULT REPRINTING

At the end of analysis cycle the message displayed is:

REP key starts activating a menu which allows reprinting all results of the last cycle or resend them to host. This can be particularly useful if the real time printing is defective due to paper missing or paper advance fault.

ESR ALIGNMENT VALUES

If it is necessary aligning the ESR results with those been obtained from the same samples by the referent method, the contacted technical service or product specialist should carry-out a correlation between the two methods. TEST1 is equipped with options to do this topic.

RACK EXTRACTION

At the end of the analysis cycle the instrument activates the rack extraction automatically. This procedure, however, can be executed manually pressing key 3 (Rack Removal) on MAIN MENU. The LCD display shows this message:

and after a few seconds

Open the front door and extract the rack and close it again. Repeat this procedure until the last rack is extracted.

REP reprint

ENTER continue

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DETECTED

REP reprint

ENTER continue

Wait

positioning

Extract rack

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TEST1

Rev.1.2 – 2015.10.10


19- NOTE for the analysis cycle and washings

1. Tubes must be inserted and locked tightly in the rack.

2. Insert the rack along the slide completely in case of TEST1THL. Insert deeply the rack in the guide in case of TEST1 equipped with direct insertion kit.

3. The analytical cycle cannot be interrupted to insert others rack of samples to analyse.

4. Four racks as maximum can be inserted in the same cycle.

5. Upon introduced the fourth rack and closed the door, the analysis cycle starts automatically.

6. If the function has been enabled, at every new analytical cycle run, the drawer or the rack guide that has accepted the rack on the previous cycle, will be rotated to 90°. The rack considered as first could be inserted on the successive position. In this way, there will be a controlled rotation of the drawers or rack guides in order to uniform the mechanical parts wearing.

7. If the availability of credits is below than the scheduled and stored, in the setup, threshold, beyond the real availability the printer is going to print out even a warning near by the reported availability. E.g. ESR 200 warning (<1500).

8. At the end of every analytical cycle and after having recovered the rack from the analyser, if the liquid quantity (blood, water, Latex) discarded into the waste tank is a value that comes into the last 200 respect the set threshold (1500 as default) and stored in the setup, the display will show the message “TANK ALMOST FULL”. Press ENTER to bypass the message and go back to MAIN MENU. Such message suggests the operator that he should empty the waste tank and reset the counter to 0 because when the tank is full (1500 points of discarded liquid), the LED of the keypad left side blinks, the printer is going to print out the message “WASTE LEVEL DETECTED-EMPTY THE TANK” and the instrument will no longer allow the run of further analysis cycle. If key 1 is pressed for the purpose to start a new analysis cycle, the display is going to show the message WASTE LEVEL DETECTED. Press ENTER to go back MAIN MENU, empty the tank and reset the counter to 0 by pressing keys 9 and then 1.

20- MAINTENANCE TIME

A counter in the analyzer, counts the executed analysis from the last maintenance time. When, along the working days, it reaches the preset maintenance warning again, which value is 30000 normally, the LED set on the left side, above the keypad, blinks. The operator, therefore, warned by the analyzer about the necessity to carry out a new maintenance service, has to call the technician trained to carry out this stage.

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TEST1

Rev.1.2 – 2015.10.10


21- WASHING PROCEDURE

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

WASHING USING 2 TEST TUBES

This option should be used during the instrument working day when the instrument activates the warning to be washed by automatic request and to avoid leaving the capillary dirty of blood for long time in absence of analysis. To activate the procedure prepare 2 test tubes filled for ¾ with distilled water and insert them in the position 1 and 2 of a rack. Press key 2 (Washing) on MAIN MENU and then insert the rack in the instrument. Wait until MAIN MENU is displayed again which point-out the end of the process.

WASHING USING 3 TEST TUBES

The execution of this option is suggested at the end of the working day to maintain the capillary cleaned during the night and therefore to increase its working life and to an easy way to remove residuals of blood particles from the needle and capillary tubing. To activate the procedure, 3 test tubes filled for ¾ with distilled water have to be prepared and put into the first three positions of a rack and then key 2 (Washing) on MAIN MENU has to be pressed. The rack has to be loaded into the instrument and then the operator has to wait until “Test 1 off” message is displayed. He can chose to continue with the ordinary activities pressing “ENTER” or to switch the instrument off for the night. On both cases and during the washing process, the needle aspirates the content of the first and second test-tubes completely and remains inside the third test-tube filled with distilled water as well as part of the capillary. Pressing “ENTER” or immediately after switching on the instrument, the needle is going to exit from the third test-tube and the instrument then is going to empty the needle and capillary. Water and any wet residual particles of blood, will be discarded into the waste tank.

WASHING PROCEDURE FOR MAINTENANCE (useful even to unlock the needle and capillary )

For a good maintenance of the instrument and in case the needle and/or capillary are obstructed, carry-out this procedure using distilled water and Sodium Hypochlorite (5% of dilution). The frequency of use can be calculated according to the number of analyzed specimens.

E.g. once per 2 weeks up to 60 specimens per day once per 1 weeks for over 60 specimens per day

The procedure is: 1. Prepare two test-tubes filled 3/4 with distilled water and put them in the 1

st and 2

nd position of a rack.

Press key 2 (Washing), to start the procedure, insert the rack into the instrument and wait for the end of the procedure.

2. Prepare one test-tubes filled 3/4 with Sodium Hypochlorite (5% of dilution) and put it in the 1st position

of a rack. Prepare one test tube filled 3/4 with distillate water and put it in the 2nd

position of the rack.. Press key 2 (Washing), to start the procedure, insert the rack into the instrument and wait for the end of the procedure.

3. In order to rinse the capillary, prepare two test-tubes filled 3/4 with distilled water and put them in the 1

st and 2

nd position of a rack. Press key 2 (Washing), to start the procedure, insert the rack into the

instrument and wait for the end of the procedure.

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TEST1

Rev.1.2 – 2015.10.10


WASHING PROCEDURE IN CASE OF DAILY CONTROLS BY MEANS OF LATEX KIT

The washing procedure in case of daily controls by means of Latex is the same of the previous procedure described (washing procedure for maintenance). It has to be used every time before starting with the control process in order to carry-out quality control of the instrument (QC).

At the end of each washing procedure, the software is going to report its value matched with the suffix T100. E.g.

At every incorrect washing procedure, the printed-out result will be 2048 and the software will generate Z * error and a new washing procedure will be requested. If T. 100 tends to reach 2960, it means that the tubing is going to be opaque. In this case try to carry-out the WASHING PROCEDURE FOR MAINTENANCE in order to reduce the opacity of the capillary. The value then should increase to 3505. If it remains closed to 2960, the technical service should be called in order to replace the complete tubing.

• Note: T. 100 value is reported on the flag list which can be obtained pressing REPRINT key within two seconds after hearing two beeps sounds immediately after turning the instrument on.

• *-Note1: Z error can be differentiated to Z-0, Z-1 and Z-2.

Z-0 is generate in case of no detected or no continuous water flow. Z-1 is generate in case, in the TEST1THL, the syringe is not able to detect the test tube filled with distilled water. Z-2 is generate in case, in the instruments equipped with direct insertion kit, the internal scanner is not able to read the code “NO” which label is applied on the drawer for the presence / absence identification of the test tube in the 1

st and 2

nd position of the rack.

� Note2: at the end of the washing procedure in case the display shows a message like:

… or: …, follow the indication described at point 8 on Page 39.(Note for the analysis cycle and washings).

========================= T. 100 (3503)

MAX Sens. 3574 T100 3503 pt

MAX Sens. 3574 T100 3503 pt

Ch2 S1 3574 S2 3574

14/11/2005

=========================

1 3574 2 3574 Washing executed Wt 3574

*** PHOTOMETER OK ***

Previous washing procedure value.

Water value read from test-tube no.1 and former maximum reading sensitivity.

Water value read from test-tube no.2 and former maximum reading sensitivity.

Read values report from the first and second tube.

Memorized value.

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Rev.1.2 – 2015.10.10


22- QUALITY CHECK USING LATEX CONTROL KIT

Latex Controls kit is a valid check tool to monitor the reliability of the analyser during its working life. The kit is supplied in a box. It can contain three test tubes filled with Latex that allow executing a total of 6 controls (sale code SI 305.100-A) or it can contain five test tubes filled with Latex that allow executing a total of 30 controls (sale code SI 305.300-A ). Before starting the Control process, the analyser can require a washing procedure. In this case, the operator should carry-out the washing procedure as “WASHING USING 2 TEST TUBES”, in the previous chapter, explains. At the end of the Control process, the printed out results are three ESR values: the first one can be closed to 9 mm/h, the intermediate one to 20 mm/h and a high level to 60mm/h. The obtained results should be compared with the values reported on the label, second table, applied on the kit package. If the obtained results are into to the expected ranges, reported on the label, it means that the analyser is calibrated correctly. On the contrary, if one or more results are out of the expected ranges, it is recommended to call the Technical Service to carry out a functional verification of the analyser and a new calibration of it.

Before each Control procedure, carry-out a washing procedure: a. Execute a first washing procedure (press key 2 at MAIN MENU) using 2 test tubes filled for ¾ with

distilled water; tubes must be loaded in the position 1 and 2 of the rack. b. Execute a second washing procedure (press key 2 at MAIN MENU) using one test tube filled for

¾ with Sodium Hypochlorite in the position 1 and one test tube filled for ¾ with distillate water in position 2 of the rack.

Afterwards:

1 Verify that the analyser is on Main Menu.

2 Press key 6 (Electronic Calibration) to start the Latex Control procedure. If the instrument needs a washing, the following message will be displayed:

Follow the instructions described above “Before each …” (point “a”).

3 …otherwise, (or when the washing is completed) the following message should be displayed:

Press key 1 to start and then take a rack. Put a test tube containing at least 3 ml of distilled water into the first position of the rack, the three latex control tubes in the positions 2, 3 and 4 respecting the right order of the labels and two test tubes containing at least 3 ml of distilled water in the positions 5

th

and 6th of the rack.

4 At the request, open the door, insert the rack in the instrument and close the door.

Upon inserted the rack with the set test-tubes, the analyser is going to start mixing and the following message will be shown. The mixing process takes about one minute and half to be completed.

Note: If you get a message STD xxxx NX means that the scanner did not read the bar code on the test tubes. In this case, enter the code manually as described in "APPENDIX E - LATEX CODES TYPED MANUALLY”.

5 At the end of mixing, the Latex Controls are analysed and on display some messages are shown. The first message appears during the first washing, the second during the latex analysis, the third during the last test tube of washing. The displayed messages will be similar to:

MAIN MENU

Make a washing

1 STD procedure

2 Modify STD

Insert rack

STD

A1 1023 A2 970

T100 3529

STD procedure

wait

A1 1023 A2 970

T100 3529

Mixing

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Rev.1.2 – 2015.10.10


Afterwards, if the correlation between the referent values and the read once overcomes the 97% (0,97) the Control process will be completed successfully. In case the correlation is below than 97%; the message “Correlation NoK, Procedure aborted” will be printed out on paper and the process aborted.

When the analysis is completed, the printer is printing the latex analysis report as on the example below and the removing rack message displayed.

Message Meaning Notes

Washing Executed *** PHOTOMETER OK *** 07/08/2007 08:03:16 Washing Executed *** PHOTOMETER OK ***

Date and time of washings are printed out to confirms the correct functioning of the photometer.

Two washing messages are printed out on paper because the Control process requires one test tube filled with distilled water, used before aspirating Latex, and other two after aspirating Latex.

Reference values LEVEL 2 = 5 ( 3 : 6) LEVEL 3 = 36 (31 : 41) LEVEL 4 = 98 (89 : 107)

ESR values and ranges the internal scanner reads from the labels at the beginning of the Control process.

The printed out values are the same reported as reference on the Latex Control kit.

Photometer Param. TEST1 UK ver. 6.51X TEST1 SN. 1640 07.09.2007 08:06:57 FDF 1.0310 T100 3481 BoosterY 1.0704 MFACT 1.0704 ========================== ESR LEVEL 2 = 6 ESR LEVEL 3 = 43 ESR LEVEL 4 = 99 ==========================

� Instrument type (Test1) � Software version � Serial Number (SN.) � Date and time of latex control. � The parameters related to the

analyser gains (FDF, BoosterY, MFACT)

� The values given from latex controls, which should stay within the expected ranges.

The results of controls analysis ESR LEVEL 2 ESR LEVEL 3 ESR LEVEL 4 have to be compared with the reference values of the first printing (reference values).

The suitable reference values could vary from Lot to Lot: refer to the instructions of use present in the kit box.

Open the loading door and remove the rack. Close the front door. From this position, the instrument can perform analysis cycle with blood.

Note: 1 At the end of the washing procedure in case the display shows a message like:

… or: …, follow the indication described at point 8 on Page 39.(Note for the analysis cycle and washings).

2 In this software version, it has been introduced an option called Latex priming. This option can be enabled or disabled by a technician trained to do technical service. Latex priming has been thought to maintain the highest Latex result reliable. It works before aspirating the Latex samples from the test tubes filled with Latex. It removes residual particles of water, still present in the capillary, released at the end of the water aspiration time from the first test tube which joins the control process.

Priming Process: At the beginning of the Latex control process and after aspirating the distilled water from the first test tube, the syringe is going to aspirate 116 micro-litres of Latex from the second test tube marked as 2. The analyser, then, is going to move the aspirated aliquot of Latex forward and backward into the capillary for a few times and then it will discarded it. Afterwards the analyser is going to aspirate the real Latex sample from the same test tube forwarded to the others for the measuring process. The last two test tubes filled with distilled water are for rinsing the capillary.

Extract rack

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FULL

WASTE LEVEL

DETECTED

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TEST1

Rev.1.2 – 2015.10.10


23- INTERNAL QUALITY CONTROL SYSTEM PRESENTATION

In order to do internal Quality Control, the TEST1 software includes a series of tools which report and plot the instrument performances. Such control tools are the following:

1. INSTRUMENT QUALITY CONTROL USING LATEX CONTROL KIT (Kit code SI 305.100 for 6 tests or code SI 305.300 for 30 test)

• The first graph represents the Control Latex results executed daily and accordingly with the results it wants to drain a linear exposition of them or drifts.

• The second graph drains the difference of the gain value, any Latex Control process generates, respect the referent position obtained from the Calibration process. The maximum CV allowed is 10%.

2. HEMATIC STATISTICAL DATA PRINTOUT Generates black and white circles which point-out cumulative and daily averages of ESR results of analysed blood samples which belong to patients who refer to the lab. From the beginning of the instrument working life, the Quality Control system stores couples of both cumulative and daily averages which day by day go to increase the plot which the maximum length represents 30 days of analysis. The complete plot, then, will be updated automatically moving the plot up and so leaving space below to add new points that represent the last day of analysis.

3. ESR VALUES DISTRIBUTION PRINTOUT There are four different plots divided in different ranges: two of them points out ESR results from 2 to 120 mm/h (cover the complete range) and the other two points out ESR results from 2 to 30 mm/h which in Italy they are considered not pathologic results. This tool is useful to each lab to split-up pathologic results from the not pathologic ones and get a referent cut-off from pathologic and not pathologic results.

4. WATER DATA PRINTOUT By a black point for each day, this wants to report the daily average of the photometrical check done during each washing procedure. The allowed CV can vary from 0 to 1,6%.

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TEST1

Rev.1.2 – 2015.10.10


INSTRUMENT QUALITY CONTROL USING LATEX CONTROL KIT

At the end of every process with Latex Control kit, each obtained result is stored in the instrument and it can be represented by a circle or asterisk in the Quality Control system. The Quality Control activation allows printing all represented circles or asterisks that form a plot. After pressing REPRINT at MAIN MENU and waiting for a couple of seconds, the following message will be displayed:

Press key 1, to display the next message:

Press key 1 (TREND ESR) to print out the following graph Press key 2 (TREND FACT) to print out the successive graph:

ESR 2 40 80 120 |------------------I----------------I----------------I I * ° I o I I I * ° I o I I I * ° I o I I I * ° I o I I I * ° I o I I I * ° I o I I I * ° I o I I I * ° I o I I I * ° I o I I I * ° I o I I I * ° I o I I

Graph explanation This graph shows the trend of the three Latex Controls values as the checks are performed along the time. The first series of the symbols (* ° o) lined up on the top, represents the ESR values of the Latex Controls process first execution. The one on the line at the bottom, instead, represents the results of the Latex Controls process last execution. Thought this graph, it is possible to see any variation in trend and any drifts from sides. Therefore, if a new Latex lot characterised by different values from the previous lot number generates shifted points on the graph, like the first four series of symbols in the aside example, it is suggested to monitor the trend of the new Latex Control lot for a few days.

-20 -10 1 +10 +20 DEV% |----------|-----------|-----------|----------| | | | * | | | | | * | | | | |* | | | | * | | | | |* | | | | | * | | | | | * | | | | | * | | | | | * | | | | | * | | Dev. St. 26,15 CV% = 8,05

Graph explanation: During the calibration process by Latex, the software identifies and stores the necessary gain called ModelFact to obtain the expected ESR Latex results. That gain is represented by the vertical axis marked number 1 (see the graph). At every Control procedure, the operator does for Quality Control, the system calculates a hypothetic difference of gain between the referent gain, of the vertical line marked 1, and the gain calculated during the process. It will not be stored but the gap value will be pointed-out inside the range of the graph by a black circle or * as in the example on the left. If the identified gain is the same as the referent ones (that it is the ideal case), there is not a gap and the point will be printed-out exactly over axis 1. Beneath the graph, the Standard Deviation (Dev. St.) and the Percentage Coefficient of Variation (CV%) of the results are reported to know whether the analyser works efficiently. In fact, if the CV% remains under +/- 10% it means that the analyser works efficiently but if the CV% exceeds this limit, a revision of the analyser calibration by the technical service is recommended.

STATISTICAL DATA

ESR STD RATE (1)

1 – TREND ESR

2 – TREND FACT

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


HEMATIC STATISTICAL DATA PRINTOUT

The Quality Control section of the program foresees the print out of the statistical data relating to the average of the daily session (white dots) and those related to the average of all data accumulated since the beginning of the instrument working life until the print out time (blacks dots). This option assumes the value of an analytical control based on the "population of the samples", and it has the effectiveness of a monitoring of the instrument.

It can be assumed that, for a large number of accumulated samples (about 6000) by an instrument in a certain laboratory, the distribution of ESR values in the graph, then the average of these values, can oscillate slightly. The greater the number of patients tested daily, the more this is true. It is also conceivable that the type of sample that is received by the laboratory is always representative of the population that refers to the laboratory, and that this population presents, on average (for large numbers), always the same values distribution.

If the analytical characteristics of the instrument are reliable, it is expected that the black points of the cumulative averages do not fluctuate a lot and remain into three standard deviations of the average of the cumulative averages, which acts as a stable reference. The graph of the cumulative average helps to see if there are systematic drifts over time which points out possible functioning problems in the instrument.

The distribution of the cumulative mean values, is undoubtedly more stable than the average values of patients on different days may come from different or particular departments, etc. This distribution, in fact, is not affected by the contribution of any abnormal samples that can be sporadically present in different percentages in the various days. One must also remember that patients with ESR in the normal range are also, usually, the majority of the samples that arrive at the laboratory. STATISTICAL DATA - Graph meaning Press REPRINT key on MAIN MENU to access in the Quality Control system. After displaying a first option, this message comes in streaming:

Press key 2 to activate the graph printout which represents the behaviour of the ESR mean values.

ESR MEAN value print out in the FULL RANGE (2-120 mm/hr)

ESR AVERAGE VALUES 2-120 (1-1) Samp. n. kkkk

5 15 25 ├───┴───┴───┴───┴───┤ xx.xx ● yy.yy ○ xx.xx ● yy.yy ○ xx.xx ● yy.yy ○ … … xx.xx ● yy.yy ○ xx.xx ● yy.yy ○ xx.xx ● yy.yy ○ STD ● zz.zz ww STD ○ vv.vv ww CV% ● cc.c

Where:

kkkk = represents the whole number of analysed samples. xx.xx = represents the cumulative mean ESR value on

ESR range from 2 to 120 mm/h. yy.yy = represents the ESR daily mean value on ESR

range from 2 to 120 mm/h. zz.zz = standard deviation of cumulative mean ESR value vv.vv = standard deviation of daily mean ESR value cc.c = CV% of the cumulative mean ESR value ww = represent the days of analysis spent to reach kkkk

STATISTICAL DATA

M (2) Sp (3) W (4)

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


Printout of ESR MEAN value in the NORMAL RANGE (2-30 mm/hr)

ESR AVERAGE VALUES 2-30 (1-2) Samp. n. kkkk

5 15 25 ├───┴───┴───┴───┴───┤ xx.xx ● yy.yy ○ xx.xx ● yy.yy ○ xx.xx ● yy.yy ○ xx.xx ● yy.yy ○ … … … xx.xx ● yy.yy ○ xx.xx ● yy.yy ○ Samples ww oooo [min – max ] STD ● zz.zz STD ○ vv.vv CV% ○ cc.c

Where: kkkk = represents the number of analysed samples xx.xx = represents the cumulative mean ESR value for samples within the range 2-30 mm/hr yy.yy = represents the ESR daily mean value for samples falling within the range 2-30 mm/hr zz.zz = standard deviation of cumulative mean ESR value vv.vv = standard deviation of daily mean ESR value cc.c = CV% of the cumulative mean ESR value ww = represents the days of analysis spent to reach kkkk oooo = reports the last value xx.xx which has to fall down

into the calculated range ( [min. and max] ) -[min = min limit allowed to the daily STD

(= cumulative mean - 3 x cumulative STD) -[max = max limit allowed to the daily STD

(= cumulative mean + 3 x cumulative STD)

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


Guide to the interpretation of the graph of values between 2-120 and the clinical / statistical meaning.

• (1-1) Samp. n. 3744 points out the total number of samples processed in 30 days.

The first couple of values (30,71 – 31,42) matched to the relative symbol, points out the

cumulative and daily averages value of the first day of analysis. The successive couples,

convey the values average of the successive day of analysis except the black symbol

which wants to be the average value between the analysis of that day and the previous

cumulative averages.

Example:

19 29 39

|-----|-----|-----|-----|-----|

30.71 ● is the cumulative average of the first day of analysis.

31.42 o is the daily average of the first day of analysis.

30.26 ● is the updated cumulative average (1st day + 2nd day)

26.38 o is the daily average of the successive day

29.78 ● is the updated cumulative average (1st day + 2nd day + 3rd day)

25.19 o is the daily average of the successive day

……. …… ……………

This graph represents the last 30 days of analysis. By this, it is possible to identify an

anomalous tendency of daily averages respect the cumulative once. This is not a big problem

because the analysed specimens that could have been come from different sites day by day,

could have been affected by pathologies which vary the daily average and the matched symbol

position in the graph. . An anomalous tendency of the cumulative averages, instead, should

alert the user for a possible systemic error.

The data are shown from the oldest (on the top) to the most recent (on bottom of graph).

Pay attention on the data interpretation. It is necessary to consider the number of specimens

that come daily and even their origin. The cumulative average line becomes stable after 100

samples stored and the daily average moves around the cumulative trend line. In this way a

problem on instrument could be pointed out immediately by a rapid deflection of the daily trend

line and cumulative averages.

The instrument is able to collect at maximum 5900 samples to calculate the average, therefore

large variations of daily statistics will not change the cumulative average in determinant

manner.

As soon as 5900 samples are reached, the first 1000 will be discarded coming back to 4900

samples. This is to avoid the cumulative average becomes too stable for a variation.

At the end of the graph, the printer prints out the Standard Deviations of both cumulative and

daily average:

STD ● 0.30 30 Standard Deviation for cumulative data (last 30 days)

STD o 4.33 30 Standard Deviation for daily data (last 30 days)

From a statistical point of view, the daily data can be considered stable if they stay into three

Standard Deviations of the cumulative average.

In this example of graph, taking into account the last cumulative average data (29.17) and the

three standard deviations of the cumulative average (0,30 x 3 = 0,9), we can say that the

average of the last day fall down inside the range whether doesn't exceed the three standard

deviations of the cumulative data.

In this example, the lower limit is: 29.17 - 12.99 = 16.18 and the upper limit 29.17 + 12.99 =

42.16. In this case, the daily value 26.54 enters inside between the two lower and upper limits,

so the instrument is working properly.

Remember that if this doesn't happen, the cause should be searched on the processed

samples during the day and from the kind of patients analysed (a lot of pathological or a lot of

healthy patients).

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


Guide to the interpretation of the graph of values between 2-30 and the clinical / statistical meaning.

This graph has both the daily and cumulative data more stable because the analysed

specimens were not affected with pathological diseases.

In this case, the considered specimens are less (2351 vs. 3744) than those represented in the

previous graph, and this is logical because the no pathologic values in Italy are surrounded

from 2mm/h to 30mm/h.

As on previous case, we can analyse the meaning of this graph and the results in terms of

stability.

• (1-2) Samp. n. 2351 this is the total number of samples processed in 30 days. The

first couple of values (13,47 – 13,85) matched to the points, points out the values average

of the first day of analysis. The successive couples, convey the values average of the

successive days of analysis.

Example:

5 15 25

|-----|-----|-----|-----|-----|

13.47 ● the black circle is the cumulative average of the first day.

13.85 o the white circle is the daily average of first day.

13.48 ● updated cumulative average (day 1 + day 2)

13.53 o daily average of second day

13.57 ● updated cumulative average (day 1 + day 2 + day 3)

14.26 o daily average of the third day

……. …… ……………

As the previous graph, this represents the last 30 days of analysis and in the graph, the

operator can identify any irregular tendency in the daily averages compared with the cumulative

ones and establish the functioning stability of the analyser.

From a statistical point of view, data can be considered stable if stays inside three Standard

Deviations of the cumulative average.

At the end of the graph, there are the Standard Deviations of both cumulative and daily

averages:

STD ● 0.09 Standard Deviation for cumulative data

STD o 1.43 Standard Deviation for daily average

In this case the last cumulative average (13.53) has to remain inside the calculated range:

( [9,24 – 17,82] ).

Samples 30 13.53 [ 9,24 – 17.82]

STD 0.09

STD 1.43

CV% 8.3

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


DISTRIBUTION PRINTOUT

From a population who refers to the same laboratory, the ESR results distribution should allocate on constant manner along the time. This is particularly true for the results distribution which stands in the ordinary range. The user, therefore, could separate the range that contains pathologic results from the one that contains no pathologic results. Eventually he can define the two ranges. Nevertheless by the distribution, it is possible to explain any daily averages deviation easy. At the beginning, averages deviation could alert the user but assuming they were not present the day before, this fact can depend from an increase of patient affected by pathologies, maybe came from particular wards. In this case verifying the distribution of the daily data it is possible to observe an increasing of the medium-high values and a constant distribution in the ordinary range. This last observation, grants that the analyser is working correctly and that the daily average swing depends only by a different composition of patients. The values distribution, moreover, allows checking the “population constancy”. This check is complementary to this described previously for the mean values.

ESR VALUES CUMULATIVE AND DAILY DISTRIBUTION PRINTOUT

Press REPRINT key on MAIN MENU to activate the statistical data printout procedure. After displaying a first option this message comes in streaming:

Press key 3 to activate the following sub menu.

Press key 1 to activate the cumulative ESR distribution printout represented by (2 -1) (2 -2) tables.

Press key 2 to activate the daily ESR distributions printout represented by (3 -1) (3 -2) tables.

Cumulative distribution printing in the range 2-120 mm/hr (step 5 mm/hr) (2 -1) Samp. n. ww Av. xx.xx Std yy.yy ============================== 1 - 5 zz.zz nn 6 - 10 zz.zz nn 11 - 15 zz.zz nn … … … 106 - 110 zz.zz nn 111 - 115 zz.zz nn 116 - 120 zz.zz nn

Where:

ww = represents the number of samples considered in the ESR range 2 - 120 mm/hr xx.xx = represents the mean ESR value of the samples yy.yy = represents the standard deviation zz.zz = represents the distribution percentage in the considered range step, respect to the total range 2-120 mm/hr nn = represents the number of samples in the considered range, respect to the total number of samples in the range 2 - 120 mm/hr

STATISTICAL DATA

M (2) Sp (3) W (4)

STATISTICAL DATA

S (1) D (2)

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


Cumulative distribution printing in the range 2 to 30mm/h (step of 2 mm/hr). (2 -2) Samp. n. ww Av. xx.xx Std yy.yy ============================== 1 - 2 zz.zz nn 3 - 4 zz.zz nn 5 - 6 zz.zz nn … … … 25 - 26 zz.zz nn 27 - 28 zz.zz nn 29 - 30 zz.zz nn Norm. jj.jj %

Where:

ww = represents the number of samples considered in the ESR range 2-30 mm/hr xx.xx = represents the mean ESR value of the samples yy.yy = represents the standard deviation zz.zz = represents the distribution percentage in the considered range step, respect to the total range 2-30 mm/hr nn = represents the number of samples in the considered range, respect to the total number of samples in the range 2-30 mm/hr jj.jj = represents the percentage of values in the range 2-30 mm/hr, respect to the total number of samples

Daily distribution printing in the range 2-120 mm/hr (step 5 mm/hr)

(3 -1) Samp. n. ww Av. xx.xx Std yy.yy =============================== 1 - 5 zz.zz nn 6 - 10 zz.zz nn 11- 15 zz.zz nn … … … 106 - 110 zz.zz nn 111 - 115 zz.zz nn 116- 120 zz.zz nn

Where:

ww = represents the number of samples considered in the ESR range 2-120 mm/hr xx.xx = represents the mean ESR value of the samples yy.yy = represents the standard deviation zz.zz = represents the distribution percentage in the considered range step, respect to the total range 2-120 mm/hr nn = represents the number of samples in the considered range, respect to the total number of samples in the range 2-120 mm/hr

Daily distribution printing in the range 22-30 mm/hr (step 2 mm/hr)

(3 -2) Samp. n. ww Av. xx.xx Std yy.yy =============================== 1 - 2 zz.zz nn 3 - 4 zz.zz nn 5 - 6 zz.zz nn … … … 25 - 26 zz.zz nn 27 - 28 zz.zz nn 29 - 30 zz.zz nn Norm. jj.jj

Where:

ww = represents the number of samples considered in the ESR range 2-30 mm/hr xx.xx = represents the mean ESR value of the samples yy.yy = represents the standard deviation zz.zz = represents the distribution percentage in the considered range step, respect to the total range 2-30 mm/hr nn = represents the number of samples in the considered range, respect to the total number of samples in the range 2-120 mm/hr jj.jj = represents the percentage of values in the range 2-30 mm/hr, respect to the total number of samples

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


WATER DATA PRINTOUT - Graph meaning

The print out of washing control allows to evaluate the efficiency of the TEST1 photometer (CPS). The graph visualizes the course of the washing signal, that is directly correlated to the photometrical signal. Normally, the instruments are regulated for an absolute value of 3600 during the washing with distilled water. This value trends to decrease during the time, because biological residuals release deposit inside the capillary. A weekly washing like described in the washing character, will bring again the photometrical signal to an absolute value of around 3500. If this signal decreases under the value of 3300 or increases above the value of 3700, the instrument will generate Z-0 error. In this case try to repeat the washing weekly process and if the value does not come again inside the range 3300-3700, call to the technical service for maintenance. Press REPRINT key on MAIN MENU to activate the statistical data printout procedure. After displaying a first option this message comes in streaming:

Press key 4 to activate the graph printout which point out the trend of the washing mean values

NOT WASHED w

3300 3500 3700 ├───┴───┴───┴───┴ xx. yyy ● xx .yyy ● xx. yyy ● xx. yyy ● xx. yyy ● xx. yyy ● xx. yyy ● xx. yyy ● xx. yyy ● xx. yyy ● xx. yyy ●

CV% = vv.vv

Where: w = Represents the missing washing number xx.= Represents the washing progressive number yyy = Represents the water daily value read vv.vv = Variation percentage coefficient.

STATISTICAL DATA

M (2) Sp (3) W (4)

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


24- ERRORS LIST ( from version 5.00C onwards ).

Error code

Cause Effect Solution

A - 0

Systematic error. It appears when 3 reading errors (NF error) are repeated consecutively.

On display appears the message “Error A-0”

The analysis cycle will be aborted.

Press any key to continue. Before starting a new analysis, carry

out a washing for at least once.

A -1 This error comes after 3 consecutive errors of incorrect syringe movement (the motor lose

more than 250 steps during rising).



It is suggested to call the technical assistance.

A - 2 Si verifica dopo 3 errori “Q-0” consecutivi (capillare ostruito) sullo stesso campione.



Press any key to continue. Before starting a new analysis, carry out

a washing for at least once.

B - 0 (Note 1)

Carriage error. The syringe carriage doesn’t go on correctly cause sensors or motor

malfunctions.

On display appears the message “Error B – TEST1 OFF”

The analytical cycle will be aborted.

Power down the instrument for 10 seconds.

Power it ON and try again.

B - 1 (Note 1)

Carriage error. The carriage cannot reach the home position cause sensors or motor

malfunctions.

On display appears the message “Error B - 1 TEST1 OFF”


Power down the instrument for 10 seconds.


C - 0 (Note 1)

Syringe error. The syringe doesn’t rise on normal manner cause sensors or motor

malfunctions.

On display appears the message “Error C – TEST1 OFF”

The analytical cycle will be aborted

Power the instrument off for 10 seconds.


C - 1

It’s a mechanic problem which generates the syringe loss of steps. It can occur when the

needle is piercing the test-tube and the syringe up and down movement.

On display appears the message “Error C 1 – TEST1 OFF”


Power the instrument off for 10 seconds. Power it ON and try again. If the problem occurs again, than call the

technical service.

D - 0 (Note 1)

EEPROM damaged / absent On display appears the message “Error

D – TEST1 OFF” The analytical cycle will be aborted.


Power it ON and try again

D - 1 (Note 1)

EPROM’s bank commutation not working. On display appears the message “Error

D1 – TEST1 OFF” The analytical cycle will be aborted


Power it ON and try again

E - 0 (Note 1)

Rotor sensor error. The rotor doesn’t rotate correctly for sensor or motor malfunctions.

This error, sometimes is also due to the front door that is not closed well or the sensor doesn't see the metallic reflecting plate.

On display appears the message “Error E – TEST1 OFF”


Power the instrument off for 10 seconds. Power it on and try again. The problem could be due ether the front door that is not close well or the

front door sensor.

E - 1

This error appears whether during the mixing process the accessing door is opened more

than 5 times.

On display appears the message “Error E-1

Analytical cycle is aborted.

The problem could be caused by an incorrect reading of the door sensor. It

is suggested to call the technical service in order to realigned the sensor

respect the door reflecting plate.

E -2

The rotor doesn’t rotate correctly for sensor or motor malfunctions. It occurs after three died away attempts, of the CPU board, to correct incorrect positions of the rotor respect the withdrawal position. It could occur even

whether the loading door has been opened frequently during mixing (voluntary or by

mistake or due to door sensor vibrations).

On display appears the message “Error E-2

Analytical cycle is aborted. Call the technical assistance.

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


E-3 All four racks have been disabled. On display appears the message

“Error E-2 Analytical cycle is aborted

Call the technical service to enable at least one rack.

F - 0 (Note 1)

System clock error. The CPU clock doesn’t run correctly.

On display appears the message “Error F – TEST1 OFF”

Analytical cycle is aborted.

Power the instrument off for 10 seconds, power it on and try again

G - 0

The cycles number has reached its maximum value (32) and has been reset.

(Only on models with Internal Bar Code Reader - IBCR)

On display appears the message “Error G”. The Patient IDs not read from IBCR

may have the first two bytes (cycle number) corrupted.

Press Enter to continue. Verify that the Patient IDs not read from

the IBCR are correct (cn snsn rk pn) that means cycle number, serial no.,

rack, position.

H - 0

Washing not executed on last analysis session (previous day). The wash missing

counter is incremented.

The following message is printed out. “Washing not executed xx” where xx is

the number of missing washings.

Pressing Enter, the instrument executes a Washing Cycle.

I - 0 (Note 1)

Pump sensor not detected. The pump rotation has not been detected cause

problems on pump motor or pump sensor.

On display appears the message “Error I – TEST1 OFF”


Power the instrument off for 10 seconds, power it ON and try again.

J - 0 EEPROM address exceeded in reading Programming error Call Technical Service

K - 0 (Note 2)

The piston’s sensor wires are broken or the sensor is out of its position.

The piston sensor doesn't sees the magnet

Call Technical Service

L - 0 The syringe lifter motor hasn’t executed a

sufficient number of steps

On display appears the message “ Error L “

Press Enter key to continue

Call the Technical Service as soon as possible.

M - 0 The syringe lifter motor doesn’t rotates and

the piston is still at home position

On display appears the message “ Error M “



N - 0 The syringe lifter motor hasn’t executed a

sufficient minimum number of steps.

On display appears the message “ Error N “



O - 0 The pump doesn’t rotate during the

withdrawal phase. Press Enter key to continue

If malfunction repeats again, call the Technical Service.

P - 0 The software has executed an incorrect

selection. Press Enter key to continue Call the Technical Service.

Q-0 The analysed sample has not been

wasted to the waste bottle Press Enter key to continue Call the Technical Service.

R - 0 The availability of test in the Smart Card has

not been loaded in the TEST1 memory.

On display appears the message “Error R”



S - 0 Generic error during data transfer from CPU

to Transfer Smart Card Press Enter key to continue

Tech. Service message, problems during writing Transfer Smart Card

T - 0 Improper attempt to transfer data from

Transfer Smart Card to CPU Press Enter key to continue

Tech. Service message, incorrect transfer procedure (Card to CPU)

U - 0 Transferring attempt from CPU to Smart Card

with CPU autonomy less than 1 Press Enter key to continue

Tech. Service message, transfer not possible, Card already full

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


V - 0 Gain value out of the working range; min.

0.6000 - max 1,6000 Press Enter key to continue

Re-program the Gain within the range, or call Technical Service

V - 1 Model Fact value out of the working range; min. 0.50 - max 2.00 (THL instruments)

Press Enter key to continue Re-program the Model Fact within the

range, or call Technical Service

V - 2 Booster Y value out of the working range; min.

0.50 - max 2.00 (THL instruments) Press Enter key to continue

Re-program the Booster Y within the range, or call Technical Service

V – 3-5 Upgrading the instrument from release 4.xx to

release 6.xx (THL instruments) Press Enter key to continue

This error will disappear automatically after having pressed Enter

V - 4

Points out that the Booster Y parameter will be extract from the division between the Gain

and the FsFact of the previous software version


This warning appears to signalling the upgrade of the parameters of the

previous software version. Press Enter to clear it

W - 0 During the analogical reading, the thermostat

has not been switched off. Press Enter key to continue


Z - 0 During the washing the water value is outside

the tolerance (800 - 1000) Press Enter key to continue

Perform the washing procedure with chlorine. If the error still remains, call

the Technical Service

Z - 1 In case the syringe is not able to detect the water test tube during a washing process.

On display appears the message "Error Z-1"

Repeat the washing procedure and if the error appears again, contact the

technical assistance.

Z - 2

In the instruments equipped by a direct insertion kit and during a washing procedure if

the error appears again, it means that the scanner has read the label that identify the

absence of the test tube.

Error Z-2 appears on display. Repeat the washing procedure and if the error appears again, contact the

technical assistance.

Y-1 Hardware error linked to the EPROM bank

change. Error Y-1 appears on display.

No problem if it occurs only once but if it occurs frequently, the EPROM has to

be changed.

Note 1: If these errors don’t disappear after switching OFF and ON the instrument, call the technical service. Note 2: This error was originally described as EEPROM problem.

USER MANUAL

TEST1

Rev.1.2 – 2015.10.10


25- ESR AND LATEX ERRORS LIST

Message Cause Solution

NF is printed instead of ESR value

The blood flow was not regular, for air bubbles or tubing / needle obstructed.

If this message begins to appear frequently, it is suggested to execute a washing cycle before proceeding with further analysis.

NR (Not Reliable) is printed instead of ESR value

The reading unit detects the transition between air (empty capillary) and blood, but not the aggregation starting. Sometimes this is also due to a poor mixed blood.

Try to mix again the blood and repeat the measure

CM = SM (Sample Missing) is printed instead of ESR value

This error appears when test tube has slipped out from the rotor. Instrument is expecting to find a tube (because it has recognized it when loaded) but at the analysis time, the tube is not physically present in the rotor.

Check tubes loaded are in conformity with technical data sheet of the instrument

On display appears the following message Increase Avail. Insert CARD

The test availability is under the set threshold. The instrument alerts the customer that is necessary to increase the test availability.

Press Enter to by-pass. To avoid the message, it’s necessary to increase availability inserting a new TEST1 CARD.

The following message is printed at power up Waste level detected EMPTY the tank

The waste tank counter has reached the value of tank alarm threshold. The instrument enters automatically in waste tank replacing procedure (9)

Replace or empty the waste tank, then press key “1- empty” to advice the instrument that the tank is now empty. The waste tank counter is so put to zero.

The following message is printed at power up Maintenance Request

The maintenance counter has reached the value of maintenance alarm (30000 by default). Maintenance is required.

Carry out the ordinary maintenance and then reset the counter to 0.

Latex Errors Message Cause Solution

The following message is printed Exceed expiry date Procedure aborted

The three control tubes are expired, the calibration control could be unreliable, thus the procedure is aborted.

Check the expiry date of the kit, if it is expired replace it with a new one and repeat the control procedure.

The following message is printed Exceed control availability Procedure aborted

The three control tubes were used more than 6 times. The calibration control could be unreliable thus the procedure aborted.

The number of controls for one Latex kit is limited to six to avoid excessive piercing of the rubber cap which allow air to enter in causing Latex damaging. Repeat the control with a new kit.

The following message is printed Different kit number Check tube labels Procedure aborted

The three control tubes don't report the same lot and sub-lot code (the last 6 figures on bar-code) thus the analyser cannot verify the calibration data coherence. Into the kit for 30 test there are 5 columns of three test-tubes that must remain matched.

Check that on labels of the three test-tubes is reported the same code of lot and sub-lot (the last 6 figures of bar-code). If the codes are different, probably one or more tubes comes from different kit or are from the same kit but from a different column (for the 30 test kit)..

The following message is printed Correlation Not OK

The values read by the reading cell are not correlated. The three values cannot be plotted over a line and thus the correlation limit falls outside the minimum reference R2 >= 0,97.

Check that the three tubes have been inserted in the right sequence and have the same level of latex; check the needle is not obstructed, if this happens, follow the washing procedures for maintenance.

The following message is printed Unavailable memory in E2PROM Procedure aborted

The memory of expirations of the kits is momentary not available or exhausted. The date memorized from the analyzer is not the current one.

Check the date of the analyser, correcting it if is not the current one. Try to repeat the control after few days (two or three) to verify if the memory frees an the message disappears. If after two or three days the message is still printed, call the technical service.

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26- APPENDIX A - USE OF TEST1-THL WITH DIFFERENT TYPES OF RACKS

By the use of special adapters it is possible inserting racks into TEST1, normally used in Cell Blood Counters (CBC), without transferring the tubes into the TEST1 standard rack. By this version, the software allows using adapters for BAYER/SIEMENS ADVIA 120 racks, Beckman Coulter LH 700 SERIES and LH 500, ABBOTT Cell-Dyn 4000/3200 (long type), ABBOTT Cell-Dyn 3500/3700 (short type), SYSMEX SF/SE/XE, ABX Pentra 80 and Pentra 120 racks.

It is necessary to codify these adapters to enable TEST1 to work with them. These adapters must be labelled as indicated in the following table:

Rack LABEL 1 (one) Rack LABEL 2 (two) Rack LABEL 3 (three)

Label

see picture

No label

label on the right

label on the left

The adapter labelling is obtained sticking properly the labels supplied by producer as indicated in the picture. This process is necessary for TEST1 to define the characteristics of each rack, its number of samples, the distance of samples in the rack , the height of tubes and so on.

The labels generate a code TEST1 reads it and match each type of adapter to the red label. The selection of the kind of rack to associate to the code label is demanded to the technician in charge to do maintenance. TEST1 can be programmed to work with three different kind of racks (maximum) at the same time.

The code label can be used on all the following kind of racks: TEST1 (default) standard rack TEST1 for Internal Bar Code Reader reading window SYSMEX RT adapter Sysmex SF/SE/XE racks with tube retaining on the caps. BAYER/SIEMENS adapter for BAYER/SIEMENS Advia 120 racks SYSMEX adapter for SYSMEX racks (not more in use, replaced from Abbott short model) ABBOTT adapter for Abbott Cell-Dyn 3500/3700 (short model), SYSMEX SF/SE/XE and ABX Penta 80 ABBOTT L adapter for ABBOTT Cell-Dyn 4000/3200 (long model) COULTER H adapter for BECKMAN COULTER LH 700 SERIES racks COULTER M adapter for BECKMAN COULTER LH 500 racks (it keeps 2 racks of 5 positions) COULTER RT adapter for BECKMAN COULTER LH 700 SERIES racks with retaining bar on caps ABX adapter for ABX Pentra 120 racks COULTER D direct insertion guide for Beckman Coulter LH 700 SERIES cassettes or Alifax plastic

racks Next page reports an example of a coded rack:

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Example: LABEL 1 = Rack TEST1 for internal barcode reader. LABEL 2 = Adapter for COULTER cell counter rack. LABEL 3 = Adapter for BAYER/SIEMENS cell counter rack.

WARNING!! Tubes must be locked in the rack properly. Note: It’s convenient to codify the most frequent used rack in the lab with label 1 or no label, with

labels 2 and 3 the less frequent used racks. Example: if the laboratory works with Bayer/Siemens rack, it should be logic assigns the mask code label 1 to Bayer/Siemens rack. Another lab that works with TEST1 rack, will use the mask code label 1 to TEST1 rack and so on….

CORRECT WAY TO INSERT TEST-TUBES IN THE RACK :

Insert sample tubes in the rack to be analysed, facing those (through the rack right side looking at the rack insertion into the instrument), so barcode labels (if available) can be read from the internal scanner (IBCR). These have to fill all positions of the rack starting from 1

ST position without leaving empty positions.

The rack can be inserted even if only one position is occupied.

Label 2 Label 1 Label 3

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27- NEEDLE REPLACEMENT PROCEDURE

The needle replacement procedure for instruments equipped by these kind of pistons is described on page 55

CBC Piston SI 195.021/M/D

The needle replacement procedure for instruments equipped by these kind of piston is described on page 58

The needle replacement procedure for instruments equipped by these kind of piston is described on page 61

CBC Piston SI 195.077

CBC Piston SI 195.021/V

Terumo Piston SI 195.023/V

Sarsted Piston SI 195.022/V

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APPENDIX B – NEEDLE REPLACEMENT PROCEDURE on piston SI195.021/V, SI195.022/V SI195.023/V up to sn 1793

This procedure is useful for all TEST1 instruments (independently from its configuration) up serial number 1793.

The below photos show the quick needle replacing procedure.

WARNINGS:

� During the needle replacing operations, it is recommended wearing 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

With instrument powered ON, open the front door to access the waste tank and rotating the metallic knob open the metallic door to access the needle-syringe group.

Grasp and throw the CBC adapter (piston) that will tilt to 45°. The piston will be unlocked automatically during the tilting.

By pressing CLEAR key at Main Menu, the following message will be displayed: By pressing ENTER the syringe group will move towards the front of the instrument, to allow the best accessibility for the needle replacing. The syringe group will stop and it will be lock to avoid any movement during the needle replacing. During this operation the following message will be displayed:

CHANGE NEEDLE ENTER continue

ENTER to end

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Take the new needle applied on the plastic front door. The ord. code for the new needle is SI 195077.

Cover the needle with a red tool (supplied) and unscrew it to remove the needle completely. This operation has to be done in safety. Discard the replaced needle.

Remove the piston, paying attention to the needle that will remain completely uncovered.

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Insert the needle thread and tight the needle, paying attention do not tight excessively to avoid the thread damage. Extract from the top the red tool, paying attention to avoid the needle contact with hands.

Insert the piston pressing it to verify that the needle can exits without problems from the top of the piston.

Push the piston toward the internal of the instrument, till the complete lockage from the magnets. Press the piston toward the bottom until the metallic tongue will hook the piston. Pay attention to hold the piston sideways like on photo, to avoid the sting from the tip of the needle. Release the piston. Holding sideways the piston, verify that moving the piston towards the bottom, the needle exits from at least 10 millimetres from the top of the piston.

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By pressing ENTER key the syringe group will be released and it moves in the working position. Close the metallic door and then the plastic front door.

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Rev.1.2 – 2015.10.10


APPENDIX C – NEEDLE REPLACEMENT PROCEDURE on piston SI195.021/M/D from sn 1794 till sn 2137

This procedure is useful for all TEST1 family instruments (independently from its configuration) from Serial Number 1794

The below photos show the quick needle replacing procedure.

WARNINGS:

� During the needle replacing operations, it is recommended wearing gloves and protective glasses, to avoid any contact with potentially infected biological material.


REPLACING PROCEDURE


Grasp and throw the CBC adapter (piston) that will tilt to 45°.

Unscrew the blockage security screw.

By pressing CLEAR key at Main Menu, the following message will be displayed: By pressing ENTER the syringe group will move towards the front of the instrument, to allow the best accessibility for the needle replacing. The syringe group will stop and it will be lock to avoid any movement during the needle replacing. During this operation the following message will be displayed:

CHANGE NEEDLE

ENTER continue

ENTER to end

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Take the new needle applied on the plastic front door. The ord. code for the new needle is SI 195077.

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

Insert the 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.

Insert the with the new needle inside the piston body and tight the needle, paying attention do not tight excessively to avoid the thread damage.

Extract the green tool and close the piston’s cover rotating toward left side.

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At this point it’s very important to check the needle comes out from the piston’s tip without any kind of impediments. To do that the piston must be held using both hands and follow the procedure explained in the next page. Be careful not to put fingers over the piston’s tip in order to avoid be pierced by the needle’s tip.

Holding sideways the piston, verify that moving the piston towards the bottom, the needle exits from at least 10 millimetres from the top of the piston. If there are no impediments, release the piston, and push toward the internal of the instrument, till the complete lockage from the magnets and release the piston.

This operation must be done following these steps:

1) using right hand press and keep down the knob located at the end of the piston

2) if the knob is hard to move doesn’t or doesn’t move, rotate a bit to the left and/or to the right the piston’s body up when the knob moves inside the piston.

3) Keep the knob inside the piston to facilitate the piston’s displacement.

Pressing ENTER key the syringe group will be released and it moves in the working position. Close the metallic door and then the plastic front door.

Push the piston toward the internal of the instrument, till the complete lockage from the magnets. Then screw the security fixing screw.

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Rev.1.2 – 2015.10.10


APPENDIX D – NEEDLE REPLACEMENT PROCEDURE from sn 2138 onward

This procedure is useful for all TEST1 instruments (independently from its configuration) starting from Serial Number 2138. The below photos show the quick needle replacing procedure.

WARNINGS:

� To start the needle replacing process, it is recommended wearing gloves and protective glasses, to avoid any contact with potentially infected biological material.


REPLACING PROCEDURE


By pressing CLEAR key at Main Menu, the following message will be displayed:

By pressing ENTER the syringe group will move towards the front of the instrument, to allow the best accessibility for the needle replacing. The syringe group will stop and it will be lock to avoid any movement during the needle replacing.

During this operation the following message will be displayed:

CHANGE NEEDLE

ENTER continue

ENTER to end

After having unscrewed the retaining screw that locks the piston assembly to the support, grasp the piston with your fingers and pull it towards you so that it will be inclined to 45°

Unscrew the piston cap. Use the supplied tool if it is necessary.

Take the green tool applied over the plastic flap internal side and insert it into the piston hole and unscrew to remove the needle.

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Rev.1.2 – 2015.10.10


Take the new kit (SI 195.077), with the needle inside, set over the plastic flap internal side and insert it into the piston hole and twist it.

Push the piston assembly gently inside the instrument up the square magnets retains it vertically and lock the piston assembly twisting the retaining screw.

Press ENTER to reset the piston assembly to home position and close the doors.

After removing the green tool re-cap the piston aiding even with the tool if it is

necessary.

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Rev.1.2 – 2015.10.10


28- APPENDIX E – LATEX CODES TYPED MANUALLY

At the beginning of each Control process by Latex kit, the internal scanner, TEST1 is equipped by, reads the label applied on the first test-tube filled with Latex and marked number 2. The scanner then is going to read the code of the second test-tube filled with Latex and marked number 3. Then it will continue reading the code of the third test-tube filled with Latex and marked number 4. If all three codes have been read correctly, then the mixing process starts automatically while the read codes are going to be stored into the chip memory of the analyser. The Control process could be concluded successfully. The read codes, then, will be maintained stored until the number of the executed Controls is over the scheduled ones. At the successive attempt to carry-out a new Control process, the instrument is going to empty the test-tubes completely discarding the residual amount of Latex still present into them. By this way, Alifax can guarantee the quality of the product to a maximum of 6 Controls or to a maximum time of 6 weeks from the first Latex aspiration. At the first use of a new kit and if the scanner cannot read one or more of the three codes, maybe the label was ruined,

each missed code could be typed manually ( * ). If this occurs, before mixing the display should show a messages like:

STD N 2

In that case type the complete code of the test-tube marked number 2. The space between the two parts of code will be assigned automatically.

STD N 3

In that case type the complete code of the test-tube marked number 3. The space between the two parts of code will be assigned automatically..

STD N 4

In that case type the complete code of the test-tube marked number 4. The space between the two parts of code will be assigned automatically.

If the scanner cannot read one or more of the three codes during the second or the remaining four Latex Control processes, the display will report the code stored at the first Control process. E.g.

STD N 2 Memo 1534 xxxxxx

In that case press ENTER basically and the stored code will be confirmed automatically.





( * ) Press CLEAR twice to go back MAIN MENU, recover the rack and take a note of the three codes on paper. After that, press key 6 again

and restart the Control process.

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29- IMPROVEMENTS WITH SOFTWARE VERSIONS (from 5.00C onwards)

Version 5.00C (ONLY TEST1 THL) � Latex Controls management inserted, with the possibility to control and calibrate the instrument using the

same latex kit. � Inserted a new statistical data printing to show the trend of each level of latex control.

Version 6.00A (ONLY TEST1 THL) � Exchanged the function of Booster Y and MFact to simplify the calibration procedure. MFact is now

calculated automatically during the calibration procedure trough the automatic calibration option. Booster Y instead represents the old Gain and its default data is 1.0000. It can be changed manually if the amplification of the instrument needs to be increased or decreased and works only on the results of haematic samples.

� Differentiated the acknowledgement and the management of different kits for the Latex Controls and the Latex Calibrators. If the analyser recognises the Latex Calibrators, it starts automatically the calibration procedure. Otherwise, the calibration procedure cannot be performed and only the control procedure can be performed.

� Introduced a new statistical printout to evaluate the efficiency of the analyser trough the verification of Latex Controls. It is shown the trend shift of the analysed data respect to reference trend of the reference values given with the Latex Controls kit.

� Inserted the control of expiration date of Latex Controls and Latex Calibrators. If the controls or the calibrators are expired or the number of analysis is more that six, the test-tubes are automatically empty and discarded from the analyser.

Version 6.00B (ONLY TEST1 THL) � Any change on Booster Y parameter will modify both haematological and latex results. � Re-enabled the manual patient ID entering through the keyboard.

Version 6.00C (ONLY TEST1 THL) � Inserted new printings for the latex controls, every time the controls are executed a printout shows also

the reference values of the controls and, if the analyser gain (BoosterY) is different from 1.000, the new reference values calculated with the new gain are printed to give a new comparing table.

� Inserted the management of a new adapter for Sysmex rack, with retention of test-tubes on the cap (similar to the adapter Beckman Coulter RT). The name of this new adapter is SYSMEX RT.

� Enabled an extra lift of the needle (positive offset) to predispose the analysers to a new system of needle replacing in safe way. This new needle change tool will be installed on the next lot of instruments.

� Each variation of BoosterY parameter will modify both the latex controls and the haematic sample results. � Re-enabled the manual entering of the patient IDs via keyboard . � Inserted the management of the external quality control (called VEQ) that disables the printing of the

reference values when a kit is recognised as an External Quality Control (VEQ).

Version 6.01A (BOTH TEST1 THL and TEST1 BCL) � The functionality of the two amplification software parameters MFact and BoosterY have again separate to

allow the independent regulation of the values of the latexes (MFact) and of those of the haematic samples (BoosterY).

� With the separation of the two amplification parameters, it has also removed the printing of OUT OF STD with the relative new reference values when the BoosterY parameter is different from 1.000.

� Correct software error that brought again the carriage to home position and showed a repetition of the same samples already analysed after the tubing priming in case of samples without the ESR request with connection to the Host computer in modality Query Host.

� Insertion of management of direct insertion guides for cassettes Beckman Coulter LH 700 SERIES and Alifax plastic racks.

� New latex controls management algorithms for a best equalization of different instruments. � New priming procedure that shares half withdrawing from the first two available test-tubes.

Version 6.01B (BOTH TEST1 THL and TEST1 BCL) � Enabled the latex management also on MicroTEST1 instruments (this functionality was not more available

starting from version 6.01A). � Inserted the possibility of connecting a serial printer on Serial Port 2 to printout the results with an external

printer.

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� Widen the limits on printout of controls and calibrators to be aligned with those printed on the label applied on both calibrators and control kits.

� Inserted the control of positioning of home for the carriage. If the carriage cannot reach the home position, the new Error B-1 is generated and shown.

Version 6.01C (TEST1 THL, TEST1 BCL and TEST1 SDL) � Insertion of management of direct insertion guides for cassettes Sysmex SF/SE/XE. � Re-enabled the washing procedure using 3 samples tubes (on BCL models this function had been

erroneously disabled) Version 6.01D (TEST1 THL, BCL and TEST1 TEST1 SDL) � This version has been replaced by the version 6.01E which has never been released on the market

Version 6.01E (TEST1 THL, BCL, SDL, YDL, MDL) � Added management rack for direct input of chargers-cell counts Bayer / Siemens Advia 120, Beckman

Coulter LH500 "Max-M." � Improved Software in the management of the carriage to keep it locked during the collection phase. � Added a check to see if the reading cell is emptied from the blood sample after analysis. If it is not empty,

it will generate the error Q-0. Version 6.01F (TEST1 THL, BCL, SDL, YDL, MDL) � Latex control procedure error present only in the configuration MDL.

Version 6.01G (TEST1 THL, BCL, SDL, YDL, MDL) � Replace the rotor last position occurred durations mixing of samples and after closing the door access

samples. � Proofreading patient identifier ID after taking the blood sample. � Fixed an issue related software expiration date Lattices whose kit was produced in September 2009 and

the expiry date in 2010.

Version 6.50B (TEST1 THL, BCL, SDL, YDL and MDL) � Insertion of management of direct insertion guides for CBC cassettes Bayer Advia 120 (Testi 1 YDL) and

Beckman Coulter MAX – M LH 500 Series (Test 1 MDL). � Improved the information printed during the analysis: if the ESR is lower than 2, the instrument will display

(if activated in the setup options) a “<” followed by the number 2. This means the real ESR is lower than 2 but the instrument “filters” at 2 to maintain a compatibility with previous systems.

� The same thing for ESR results higher than 120, in this case the instrument will display (if activated in the setup options) a “>” followed by the number 120. This means the real ESR is higher than 120 but the instrument “filters” at 120 to maintain a compatibility with previous systems.

Version 6.51B (TEST1 THL, BCL, SDL, YDL MDL and XDL) � Management of the direct insertion kit for CBC Coulter DXH 800 (Test1 XDL) cassettes. Version 6.51C (TEST1 THL, BCL, SDL, YDL MDL and XDL) � Multilanguage software (Italian, English, German, French and Spanish). � Correction of the direct insertion kit for CBC Coulter DXH 800 (Test1 XDL) cassettes management. It avoids the A-0 error generation after three consecutive NF (No Flow). � Possibility to choose the typology of the result printing (detailed or compressed). � With this software, the analysis time has been reduced from 24 seconds to 20 seconds. Version 6.51D (TEST1 THL, BCL, SDL, YDL MDL and XDL) � Introduced the opportunity to carry out priming for Latex Control. Version 6.51E (TEST1 THL, BCL, SDL, YDL MDL and XDL) � It has been added a warning message for having reaching a pre-set threshold which corresponds to the

full tank level less than 200 points. By this point, the display requests to empty the tank and reset the counter to 0. The analyzer however allows the execution of analysis cycles until the tank is full totally. When the tank is full totally and accordingly the counter counts the maximum level, the analyzer stops working until the tank is empty and the counter reset to 0.

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Rev.1.2 – 2015.10.10


� It has been erased the E2 error.

� The Z-0 error has been slit-up to: Z-0, when a missed stream of water is detected; Z-1, when the syringe is not able to detect the test tube presence; Z-2, when the scanner of an instrument equipped by a direct insertion kit, reads the label "NO" test tube.

� Additional data logger which containing information about the last 8 calibrations (NO CONTROLS).

� It has been added a data logger to report errors detected by the instrument.

� It has been changed the printout format of the ESR quality control of the normal values (2-30) from "CV%> MIN <MAX" to "CV% [MIN - MAX]".

� In the instruments equipped by direct insertion kit, it has been increased the working life of the retaining latches. This function assigns on each new analysis session the "Rack 1" position automatically. The true "rack 1", therefore, will be to position 1 at every 5 sessions.

� It has been added a function to disable damaged racks. The remaining ones could be used normally.

� It has been solved the transmission / reception errors of the character 0x17 released to / from hosts.

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Rev.1.2 – 2015.10.10


30- SANITIZATION 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 sanitization procedures of a working instrument: refer to the Sanitization Form

(APPENDIX F on page 63) The Sanitization Form MUST be filled up and accompany the instrument. In case the sanitization 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 F at each sanitization and to fill it according to the sanitization procedure.

31- SWITCH OFF THE INSTRUMENT

Before switching OFF the instrument it is essential carry-out a WASHING procedure with three test-tubes filled with distilled water. Then the instrument can be switched OFF. Switched ON the instrument again, the instrument is going to print out “WASHING PERFORMED”, whether the washing was done previously. On the contrary the message will be WASHING NOT PERFORMED .

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32- TEST1 - REFERENCES Manufacturer:

ALIFAX S.r.l. Via Merano 30 33045 Nimis (UD) Italy Tel +39 0432 547454 - Fax +39 0432 547378

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

The instrument is ETL certified for the North American market by Intertek

Worldwide distributor:

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

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33- APPENDIX F – SANITIZATION FORM

This module must be filled by the Laboratory / Technical Service Engineer and attached to the instrument before the shipment. The cleaning of the instruments can be difficult regards the elimination of the etiological agents of the TSE (Encephalopathy Spongiform Transmissible). It is reported that after exposure to high titre preparations of TSE agents, detectable infectivity can remain bound to the surface of the laboratory instruments. The removal of all adsorbed protein by the use of sodium hydroxide or chlorine releasing disinfectants (e.g. 20 000 ppm. Chlorine for 1hour) have been considered acceptable approaches where equipment that cannot be replaced as been exposed to potentially contaminated material. Description of sanitization procedures to be done by the Laboratory:

Switch ON the instrument: OK NOK

� Execute the following washing procedure 1. Perform a first wash using two tubes filled with distilled water. � � 2. Perform a second wash using one tube filled with water and one tube filled with sodium Hypochlorite. � � 3. Empty and clean very well the Waste tank avoiding to leave blood residual inside � � For the disposal of the waste tank content follow the standard safety procedures in use in the laboratory. If due to a failure, the instrument cannot be switched ON, mark as NOK .

Description of sanitization procedures to be done by the Technical Service Engineer: Wear protection tools (glove and glasses) and remove the cover of the instrument. If Laboratory Operator marked the washing procedure as NOK, verify if it is possible to make in some way the washing procedures.

� Execute the following washing procedure OK NOK

1. Perform a first wash using two tubes filled with distilled water � � 2. Perform a second wash using one tube filled with water and one tube filled with sodium hypochlorite � � 3. Empty and clean very well the Waste tank avoiding to leave blood residual inside � � For the disposal of the waste tank content follow the standard safety procedures in use in the laboratory. If due to a failure the instrument cannot be switched ON, mark as NOK.

To continue with the sanitization procedure, switch the instrument OFF 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 � �

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

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

SANITIZED

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