Ed. 1 Rev.13 -2014 -2014,, Apri l, 05
ROLLER 20 LC OPERATOR OPERATOR MANUAL Software v ersion 6.51 6.51C C Capillary Micro-photometer for the Erythro-Sedimentation Rate ( ESR)
In Vitro Diagnostic Medical Device for Professional Use Copyright Alifax S.P.A. This manual contains ALIFAX reserved information. All rights reserved. Unauthorized copying of this manual or parts of it is prohibited. ROLLER 20 software is is provided only with with restricted and limited limited rights based on Italian regulations. regulations.
OPER OP ERA A TO TOR R MA MA NU NUA AL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, -2014, Apr il, 05
SI R20LC – ROLLER20LC USER MANUAL REVISIONS
Rev.
Description
Issue date
13
Inserted EAC certification Logo
05/04/2014
12
Technical specification upgrade (page 5)
05/02/2014
11
Technical specification upgrade (page 5)
15/01/2014
10
Page 54 updated +revision page inserted
30/09/2013
9
Page 21 updated
20/12/2012
8
Technical sheet Upgrade + add error messages on chapter 28 (alert list)
27/08/2009
7
Re-written chapter 32 and add APPENDIX B Sanitation module.
02/04/2008
6
Chapter 13 updated
30/09/2009
5
Re-written the “Priming process” chapter
18/05/2009
4
“ Washing procedure” chapter updated
20/01/2009
3
Rewritten chapter dedicated to maintenance.
27/08/2009
2
Technical sheet Upgrade (chapter 2)
06/02/2008
1
Upgrade Latex Calibration and Control Procedures
27/04/2007
0
Release software version 6.51C
20/11/2006
Page 1 ESR_UM_SIR20LC_ ROLL ROLLER20LC ER20LC SW 6.51C_1-13_EN.DOC
USER MANUA MANUAL L
OPER OP ERA A TO TOR R MA MA NU NUA AL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, -2014, Apr il, 05
Summary
Page
1 SIMBOLS INDEX AND LABELS .......................................................... .................................................................. .. 3 (D102.06.03 - 1.7 –27.08.2009) 2 TECHNICAL SPECIFICATIONS ........................................................................................... 5 3 WARNINGS TO ENSURE A CORRECT INSTRUMENT USE................................................................................. USE ................................................................................. 9 4 UNPACKING AND INSTALLATION ................................................................ ....................................................... 11 5 VOLTAGE SELECTOR AND FUSES REPLACEMENT REPLACEMENT ....................................................... ................................. 12 6 SYRINGE CHOICE ........................................................ .................................................................. ...................... 13 7 KEYBOARD SPECIAL FUNCTIONS .............................................................. ....................................................... 14 8 SWITCH the ANALYSER ON ..................................................................................................................... ........... 15 9 WASTE TANK LEVEL MESSAGE .................................................................. ....................................................... 15 10 MAIN MENU .......................................................................................................................................................... 16 11 TO CHANGE DATE & TIME ................................................................ .................................................................. 17 12 PAPER LOADING PROCESS INTO THE PRINTER ............................................................ ................................. 18 13 SMART CARD TO INCREASE CREDITS ............................................................................................................. 19 13.1 AVAILABILITY TEST INCREASING INCREASING ................................................................ ...................................................... 19 13.2 UNIVERSAL CARD ............................................................................................................................................... 19 13.3 SMART CARD ERRORS .......................................................... .................................................................. ........... 20 14 USE OF PAEDRIATIC TEST-TUBE ............................................................... ....................................................... 21 15 TEST TUBES INSERTION READING THE ID CODE (by External Bar Code Reader) ......................................................... 22 16 TEST TUBES INSERTION AFTER HOST INTERROGATION ........................................................ ...................... 24 17 TEST TUBES INSERTION (MATCHED WITH PATIENT ID CODE TYPED MANUALLY) .......................................................... .......... 26 18 TEST TUBES INSERTION (MATCHED WITH AUTOGENERATED ID CODE) ............................................................................... 27 19 PRIMING PROCESS and MEASURING PHASE .................................................................................................. 28 20 ESR RESULTS PRINTED OUT ON PAPER ................................................................................... ...................... 29 21 RESULTS REPRINTING .......................................................... .................................................................. ........... 30 22 TEST TUBES EXTRACTION................................................................ ................................................................. 30 23 MANUAL WASHING PROCEDURE ............................................................... ....................................................... 31 23.1 WASHING USING 2 TEST TUBES ............................................................................................................ ........... 31 23.2 WASHING USING 3 TEST TUBES ............................................................................................................ ........... 31 23.3 WASHING PROCEDURE FOR MAINTENANCE (useful even to unlock the needle and capillary ) ............................................... 31 23.4 WASHING PROCEDURE PROCEDURE IN CASE OF DAILY CONTROLS BY MEANS OF LATEX KIT .................................... 31 24 LATEX FOR QUALITY CONTROL PRESENTATION. PRESENTATION. ......................................................... ................................. 33 24.1 QUALITY CHECK USING LATEX CONTROL KIT ..................................................................................... ........... 33 24.2 RECALLED LATEX ID CODE .............................................................. .................................................................. 35 24.3 LATEX CODES TYPED MANUALLY.............................................................. ....................................................... 35 25 QUALITY CONTROL TOOLS PRESENTATION ........................................................ ........................................... 36 25.1 QUALITY CONTROL BY MEANS OF LATEX CONTROL KIT ................................................................... ........... 37 25.2 HEMATIC STATISTICAL DATA PRINTOUT ............................................................. ............................................ 38 25.3 DISTRIBUTION PRINTOUT PRINTOUT ...................................................................................... ............................................ 42 25.4 WATER DATA PRINTOUT PRINTOUT - Graph meaning ....................................... ................................................................. 44 26 GAIN ADJUSTMENT ................................................................ .................................................................. ........... 45 27 MAINTENANCE TIME ............................................................... .................................................................. .......... 46 28 GENERIC ERROR LIST ............................................................ .................................................................. .......... 47 29 ALERTS LIST and LATEX ERROR ERROR LIST.................................................................. ............................................ 48 30 NEEDLE REPLACEMENT........................................................ .................................................................. ........... 49 31 SOFTWARE REVISION HISTORY ................................................................. ....................................................... 51 32 SANITATION PROCEDURE................................................................................................. PROCEDURE................................................................................................. ................................. 52 33 BEFORE SWITCHING OFF THE ANALYSER ...................................................................................................... 52 34 REFERENCES ...................................................................................................................................................... 53 35 APPENDIX A - SANITATION SANITATION FORM FORM ............................................................... ...................................................... 54
Note:
The paragraphs written with the italic characters (as on this note) were added or modified as regards the previous version of the manual. Page 2
ESR_UM_SIR20LC_ ROLL ROLLER20LC ER20LC SW 6.51C_1-13_EN.DOC
USER MANUA MANUAL L
OPER OP ERA A TO TOR R MA MA NU NUA AL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, -2014, Apr il, 05
1
SIMBOLS INDEX AND LABELS
Inside this manual and also in the instrument, can be find out many symbols used internationally. Here we describe the meaning of this symbols:
Symbol
MEANING
Symbol
Attention, read the instruction for the use
Product Code
_ REF _
MEANING
Manufacturer
Ground terminal connection
In Vitro Diagnostic Medical Device
SN
Caution: parts in movement inside the instrument
Serial Number of the instrument
Waste tank
Attention: Biologic risck
Attention: High voltage Attention: Sharpened objects inside the instrument
ROLLER 20 _ REF REF _ SI R 20-LC _ SN SN …………………..……….…… (yyyy/mm) ………..………….... Power Pow er 115/230 Vac 50/60 Hz 225 VA Mains Fuses T2.5A 5x20 mm SIRE Analy tical Systems
Made in ITALY
Rx Only (USA)
THERMOSTAT TEST OK Date: SIRE Analytical Systems
PWR SUPPLY TEST OK Date: SIRE Analytical Systems Page 3 ESR_UM_SIR20LC_ ROLL ROLLER20LC ER20LC SW 6.51C_1-13_EN.DOC
USER MANUA MANUAL L
OPER OP ERA A TO TOR R MA MA NU NUA AL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, -2014, Apr il, 05
Roller20
s.n. ______
Techni Techni cal Servic e Tel. Tel. No. ______________ _____________________ _________ __
FUSE 2,5AT5x20 or 3 15AT5x2 15AT5x20 0
Page 4 ESR_UM_SIR20LC_ ROLL ROLLER20LC ER20LC SW 6.51C_1-13_EN.DOC
USER MANUA MANUAL L
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
2
TECHNICAL SPECIFICATIONS
(D102.06.03 - 1.9 )
OPERATIONAL SPECIFICATIONS Equipment name:
ROLLER 20 (code SI R20-LC): model with thermoplastic white cover and Latex Control management.
Equipment descript ion :
Automatic Analyzer for the determination Sedimentation Rate (ESR).
Analysis pri nciple :
Photometrical capillary stopped flow kinetic analysis.
Results:
Given in mm/h in the range from 2 to 120 mm/h.
Sample requirements:
- the sample must be of whole blood collected in EDTA anti-coagulant. - the blood sample must be neither coagulated nor hemolyzed.
of human
blood Erythrocyte
- it would be better to test the sample within 4-6 hours from venipuncture or within 24 hours if kept at +4/+8 °C, provided it is rewarmed to room temperature before testing. - the blood samples must remain capped (don’t uncap and recap them since the instrument’s performances would be affected). - the minimum blood volume (dead volume) is 800 microliters, the working volume is about 175 microliters while about 87 microliters per sample are withdrawn from the first and second samples for priming. In case there is only one sample, the amount withdrawn for priming is around 175 microliters. - samples separation inside the capillary using air bubble of about 530 mm (255 microlitres).
Tube requirements:
Test-tubes 13x75 like BD Vacutainer® or Greiner Bio-one or with 13 mm diameter and from 75 to 83 mm high, cap included, verifying that the sample volume does not exceed the 50-60% of the total volume of the test-tube. Optional Terumo® cap adapter for Terumo Venojet II® tubes Optional Sarstedt® cap adapter for Sarstedt Monovette® tubes
Operative performances: Samples mixing can be programmed in speed (60, 32 and 24 RPM) and in number of rotations, from 2 to 1000 rotations (recommended 32 RPM @ 140 rotations, about 4,4 minutes of mixing). First result available after 4,4 minutes of mixing and 20 seconds of analysis, the other results (from 2nd to 18th) are produced in 20 seconds each. 18 samples processed in 10 minutes (100 samples per hour) without considering the time taken for loading and removing the test-tubes from the instrument. The above throughput could be delayed in case of connection to the Host Computer with reply output time more than 1 second. -Audible alarm in case of error or malfunction: The instrument emits a series of 62,5dBA sounds until the error is solved.
Capacity:
20 position wheel, 18 positions for samples plus 2 positions for washing test tubes.
Analytical performances (obtained with 3 ml Test-tubes): Trials made using TEST1 as comparison instrument [1]: Correlation: R2 = 0.97, Slope: 0.942
Repeatability: Evaluated by performing 5 replicates using the same samples ob blood [2] ESR values range (mm/h) ∼ 0
– 20 ∼ 21 - 40 ∼ 41 - 60 ∼ 61 - 80 ∼ 81 - 120
N° Samples 10 11 8 5 3 37
Coefficient of Variation (%) 8.96 4.06 2.78 2.70 2.38 4.99 Page 5
ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
To do this evaluation, has been used 37 samples, obtaining a mean CV% = 5% ranging from ∼ 0 - 120 mm/h
Stability of samples sto red for 24 h at room t emperature: In order to view the effects of different methods of storage on the ESR value, 272 K3EDTA-anticoagulated whole blood samples, some of which have been stored at 4 °C and some others at room temperature, have been analysed after 4 hours and after 24 hrs on TEST1 device. Good correlation was found between the results taken at 4 hours and those taken at 24 hrs on the samples stored at 4 °C (r=0.980). Those stored at room temperature did not correlate quite as well as those stored at 4 °C, but still had very good correlation (r=0.917) (3).
Method limitations:
1. The erythrocyte sedimentation rate is a phenomenon confined to fresh blood and transient (4), not a haematic matrix component (at corpuscular / molecular level). The procedures used to determine the ESR cannot be calibrated as they are susceptible to a variety of errors (temperature, haematocrit, erythrocyte mean corpuscular volume, plasma viscosity, etc.)(4). Based on the acquired experience on TEST1, also ROLLER 20, being a member of the same family, can be considered affected by these variables to a limited degree. For this reason it is possible to observe instrument performances deviations compared to other procedures if the above variables are not taken into account.
2. Erythrocyte sedimentation remains an only partly understood phenomenon….is a nonspecific reaction (from a clinical point of view)… (4) that is affected by several technical aspects (5).The ESR is often normal in patients with cancer (5). International guidelines for diagnosis and management of multiple myeloma do not mention the Erythrocyte Sedimentation Rate (6). However there are national guidelines that include ESR together with other clinical tests. It is then necessary to point out that even though TEST1 analytical performances have been confirmed in patients affected by multiple myeloma (7,8), there have been some cases of patients affected by multiple myeloma in which TEST1 has reported clinically negative ESR values in comparison to other methods. Based on this experience there could be cases in which ROLLER 20 gives low ESR results likewise TEST1 in presence of Multiple Myeloma. It is then highly recommended to perform other tests together with the ESR in the diagnosis of cancer since a normal ESR value is not enough to exclude that the patient is not affected by this pathology. Furthermore in presence of this disease it is possible to observe deviations form other methods since other phenomena in addition to the rouleaux formation can contribute to the sedimentation like for example amorphous aggregates formation (crystallization of paraproteins or mineral materials like calcium) resulting from bone tissue alteration.
3. Samples mixing is programmed at the beginning of the analysis with the purpose of disaggregating erythrocytes. An inefficient disaggregation or micro-clots presence can affect the results given by the instrument that in fact measures erythrocytes aggregation kinetics.
4. The above instrument performances have been obtained using test tubes with a capacity of 3 ml and 13x75 mm size with K3EDTA anticoagulant. This kind of tubes has a sufficient air volume that favours the blood homogenization and consequently the results reproducibility.
ENVIRONMENTAL AND PYSICAL SPECIFICATIONS Permissi ble environment condit ions 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. Page 6
ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
Humidity from 5% to 95% - no dew
Size and weight:
Voltage:
Width: Depth: Height: Weight:
320 mm 560 mm 580 mm 23,2 Kg
ELECTRICAL SPECIFICATIONS 230 Vac ± 10% or Power cons: 100 VA, about 56W 115 Vac ± 10% selectable with voltage selector Switch on cons: 225 VA, about 135 W
Frequency: 50 or 60 Hz ± 2 Hz Classification : Class I (EN61010-1 – IEC 1010-1 – CEI 66-5) OTHER OPERATIVE SPECIFICATIONS: Heat dissipation i n the environment: about 190 BTU/hour
Noise: 54,0 dB(A)
Maximum rated altitude:
3000 mt asl
Communication :
2 serial RS232 DB 25 ports located on the rear side of the instrument: Port 1 is dedicated to connect an external scanner Port 2 is dedicated to connect the instrument to an Host Computer
Functioning :
The instrument is designed to remain switched ON 24 hours a day, it is however suggested to switch it off at the end of the working day, applying previously a washing procedure using 3 washing tube to ensure a long capillary’s and sensors’ life.
Restrictions:
Indoor user appliance
Rated pollution degree:
Grade 2
Working life of the instrument:
10 years (if maintenance is done correctly)
CONSUMABLES Printer Paper : Smart Card :
Waste Tank :
Thermal roller 57 mm x 25 meters (code SI19580001 4 rolls) Conform to ISO 7816-1 specifications - 85.6 x 54 x 0.8 mm Coded using SIRE Analytical Systems / Alifax Group proprietary algorithm. Available for 1,000 (Ord. code SI 195.901) - 4,000 (Ord. code SI 195.904) - 10,000 (Ord. code SI 195.910) - 20,000 (Ord. code SI 195.920) tests / Universal Card for TEST1 family analyzers (TEST1; MicroTEST1; Roller 10; Roller 20). 250 ml plastic waste tank with screw cap (code SI10280101)
INTERNAL QUALITY CONTROL TEST1 Family Quality Control: it is a software (code SI19562001) designed to collect and process the data from one or more TEST1 family analyzers (TEST1, MicroTEST1, ROLLER 10, ROLLER 20) for evaluating their performances.
Latex Control s : ♦ ♦
Latex Controls for TEST1 family analyzers allow the control of the calibration stability of TEST1, MicroTEST1; ROLLER 10 and ROLLER 20. They are available in two kinds of test tubes: 13x75 mm Greiner: Latex Contr ols (6 tests) - c ode SI 305.100-A;
Latex Cont rols (30 tests) – co de SI 305.300-A 11,5x66 mm Sarstedt: Latex Contr ols (6 tests) - c ode SI 305.102-A; Latex Cont rols (30 tests) - c ode SI 305.302-A VARIOUS / OTHER FEATURES
Patient identification: External CCD bar-code reader (SI19582001).
Common features:
- New design with thermoplastic cover, front door for an easier access to waste tank and to the needle. Page 7
ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
- Simplified-needle replacing procedure with magnetic unlocking and screw needle - Automatic rotation of the wheel during the test-tube insertion / removal. - Automatic priming at the end of the mixing cycle. - Simplified Smart Card downloading using a single operation. - Automatic washing if no blood flux is detected after three successive test-tubes. - Automatic washing at the end the analysis cycle (programmable from 0 to 99 minutes). - Photometer check at the end of each washing to ensure continuous control of instrument. - Management of Latex Controls Kit for TEST1 family analyzers SI 305.100-A/SI 305.102-A (6 tests) – SI 305.300-A/SI 305.302-A (30 tests) for the control of the calibration stability of the instrument.
REFERENCES: (1) Micoli M. et All. Lab. Analisi Chimi co-Clinic he ed Ematologic he Osp. Civi le Verona: “ Roller T1: Una nuova generazione di analizzatori per la Velocità di Eri trosedi mentazione” , Biochi mica Clinic a, 2004, Vol 28, pg 203 (2) Kagawa Yuko 1, Nobuko Ikeda1, Shingo Ito 1, Makino Sahei 2, Miyake Noriko 3: Clinical Test Section of Eiju Hospital 1, Finggal Link Co. Ltd 2, Dept. of Clinical Pathology of Juntendo Univeristy 3: “Evaluation for ESR automated measuring instrument with EDTA” 36th Japan Society for Clinical Laboratory Automation , 30 September 2004, Japan. (3) E. Heverin (Galway-Mayo Institute of Technology , Ireland): ” Comparison of the Westergren method versus the TEST1 techniqu e for determining the Erythro cyte Sedimentation Rate”, May 2002, private commu nicatio n (4) NCCLS “ Reference and Selected procedure for the Erythro cyte Sedimentation rate (ESR) Test; Appro ved StandardFourth Editi on” , Vol. 20 No. 27 (5) Sox HC, Liang MH: “The Erythr ocyte Sedimentation Rate” , Annals of Internal Medicine 1986; 105:515-523. (6) NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology “ Multipl e Myeloma” (V.I.2007) (7)
Ajubi et al.: “ Determination of the lenght of sedimentation reaction in blood using the TEST1 syst em: compari son with the Sedimatic 100 method, turbi dimetri c fibr inogen levels, and the influ ence of M-proteins ” , Clin Chem Lab Med 2006; 44 (7): 904-906
(8) Mercurio S. et al.: “ Comparison between two methods for ESR measure in patients affected by myeloma” , 37° SIBioC National Congress, 11-14 October 2005 Rome.
Page 8 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
3
WARNINGS TO ENSURE A CORRECT INSTRUMENT USE
The manufacturer does not assume any responsibility for any damages to persons or things due to improper use of the instrument, installation not in compliance with the manufacturer's specifications, use of the instrument not in security, use of not suitable materials regarding those specified in the user's manual, use of the instrument for various scopes different from those for which it has been designed and built, use of the instrument by not expert staff person or however non-authorized to the use of the instrument and/or in case the sanitization procedure will not be carried on if required.
Be sure that the instrument is connected to an efficient ground before its use.
Check the waste tank level before starting the measures. Empty or replace the waste tank, if filled to security level; for the disposal of waste tank content, follow the standard safety procedures in use in the laboratory.
Switch the instrument on and wait for at least 20 minutes before its use to reach the thermal circuitry equilibrium.
Check if the tube contains at least 1 ml of blood and verify that the blood is neither haemolysed nor coagulated. Use exclusively blood samples withdrawn in EDTA as anticoagulant (K2 or K3)
Blood samples must remain capped. Don’t uncap and recap them because this could corrupt the instrument performances.
Use, preferably, tubes with a capacity of 3 ml verifying that the sample volume does not exceed the 5060% of the total volume of the test-tube to optimise the sample homogenisation. The use of test tubes with different volumes/capacity might change the effect of the instrument performances.
Start the analysis within 4-6 hours from venepuncture. Otherwise keep the samples in refrigerator at + 4÷8 °C for a maximum of 24 hours. If the samples have been conserved in refrigerator at + 4÷8 °C. it is necessary to leave them at room temperature at least for 30 minutes before executing their analysis.
Carry out the "WASHING PROCEDURE" with peculiarity in order to maintain the instrument efficient along the working time.
For professional in vitro medical diagnostic use only.
The instrument is designed for indoor use only
For your safety, if any parts are damaged, demand original spare parts, specially for the parts connected to mains (power cord, fuse-holder and mains switch …), for the replace.
The instrument, can be exposed to potentially infective materials, is therefore indispensable to adopt all the precautions and warnings necessary apt to avoid the contact in accordance with national laws. .
Avoid the use of the instrument near electromagnetic sources like, for example, mobiles, CB’s, radio transmitting units and similar.
Battery for CPU S195.001C is Wentronic #23323 BH170-3P; Ni MH; 3,6V 230 mAh..
RISCHIO BIOLOGICO- USARE I GUANTI BIOLOGICAL RISK - USE GLOVES PERICOLO - NON TOCCARE LA PA RTE ALTA DEL PISTONE DURANTE IL CAMB IO AGO DANGER- NEVER TOUCH THE UPPER AREA OF PISTON DURING NEEDLE REPLACING
If the instrument is new and it has been stored in cold places, before lighting it wait for at least 30 minutes in order to avoid any damages due to dew presence on internal parts.
Keep away any kind of objects, liquids, or substances not required for the use of the instrument. Page 9
ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
Switch the instrument off before connecting external devices as External Bar Code Readers, printer cables or RS232 serial cables.
Use original spare parts only supplied from the manufacturer.
Do not remove panels neither camper the reading sensor. The maintenance operations must be carried out only by technical personnel authorized from the manufacturer.
Prior to install and use the instrument for the first time, it is suggested an evaluation of the electromagnetic environment
Do not use the instrument in proximity of sources of strong electromagnetic radiations (e.g. mobiles, CB’s, radio transmitting units and similar or unshielded intentional RF sources) as these may interfere with the proper operation of the instrument
In order to avoid possible mistakes in the Query-Host communication and/or the transmission of patient ID to the Host computer, it is recommended the use of bar-code codification which includes the “checkdigit” option in its protocol.
Battery for CPU S195.001C is Wentronic #23323 BH170-3P; Ni MH; 3,6V 230 mAh..
Instrument is compliant with IEC 61326 emissions and immunity requirements
PROCEDURE OF INSTRUMENT WASTE AT THE END OF ITS OPERATIONAL LIFE As stated on European directive 2002/ 96/CE on waste of electrical and electronic equipment (WEEE) appropriate measures should be adopted to minimize the disposal as unsorted municipal waste and to achieve a high level of separate collection of WEEE, according to the applicable local laws and rules. The crossed-out wheeled bin symbol on side, placed also close to the plate of the apparatus, points out the necessity of the separate collection of the electrical and electronic equipment (WEEE). The separate collection of this instrument at the end of its life is organized and managed by your distributor. The user who is going to get rid of it will therefore contact his distributor and follow the system that he has adopted in order to dispose the separate collection of the equipment that has reached the end of its working life. The unauthorized disposal will be pursued according to the local laws and the rules in the nation of use. Penalties will be effective, proportionate and dissuasive.
Page 10 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
4
UNPACKING AND INSTALLATION
Qualified for the installation personnel To avoid the guarantee invalidation, the installation of this apparatus cannot be done by a final user, but it must be done by a qualified technician being authorized from the manufacturer. In this way, any possible problem that could jeopardize the work of the instrument or its results, can be evaluated and eventually resolved by these trained people.
Packing control The instrument comes packed in a carton box with wood socket. Before unpacking it, carry-out a pack verification verifying if sides and corners of the box are damaged. Check the wood base also. Any damage, has to be reported in the installation and Testing Form documentation a vailable in the instrument package.
Unpacking Two people are required to unpack the instrument because the weight and the volume of the instrument don't allow to be performed by a single person. Open the pack from the top, extract the first box that contains the accessories and then the instrument from sides using the cardboard tool that facilitates that work. Place the instrument on the floor or on a low table to remove of the protective nylon foil easily. Report any damage of instrument plastic covers on the Installation and Testing Form.
Packing control contents Beyond the instrument, the pack contains a flat box with all the necessary accessories for a correct installation of the instrument. All these accessories are listed on the Packing List form and they could vary according with the instrument configuration. The packing content and the accessories box must contain: no. 01 ROLLER 20LC instrument. no. 01 packing List form. no. 01 installation and Testing form. no. 01 declaration of CE conformity. no. 01 final Testing certificate no. 01 mains cable no. 02 thermal paper rolls (one is installed, one is in the accessories box). no. 02 waste tank (one is installed, one in the accessories box) no. 02 mains fuses Moreover, according to the configuration of the instrument, the following accessories may be found: no. 01 external bar-code reader (EBCR) Refer however to the Packing List form for the control of the packing and accessories box contents, signaling any difference between the pack contents and those listed on the Packing List on the Installation and Testing form. This will help us to guarantee better controls during manufacturing and packing.
Instrument installation The instrument must be installed on a working table able to support its weight (about 40 Kg) and providing enough space on the right side to reach the power supply switch, located on the back side of the instrument, just above the mains cord. Choose a location sheltered from direct sun light and far away from moisture fonts in order to allow accuracy work and to increase the instrument working life. Besides, provide at least 10 cm of clearance on the back side of the instrument to allow the connection of the mains cable and data cable for the connection with the Laboratory Informative System (LIS). Avoid connections to mains through plug adapters and choose an electrical outlet far from strong impulsive voltages generated, usually, from centrifuges, refrigerators, elevators and freight elevators. Before connecting the cable to mains outlet, make sure that the mains voltage selector, located on the back side of the instrument and just above the mains power switch, corresponds to the supplied voltage. Details of it
are reported in the next page. Moreover, before powering the instrument on, open the front flap and check if the waste tank has been put in its location and if the terminal part of the capillary has been inserted in it. Afterwards, light the instrument and check if MAIN MENU is displayed at the end of the initialization procedure. Any possible anomaly must be signaled on the Installation and Testing form document.
Page 11 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
5
VOLTAGE SELECTOR AND FUSES REPLACEMENT
Before switching the instrument on for the first time, it is necessary to verify the position of the voltage selector The factory sets the voltage to 230 Vac. Locate the voltage selector on the rear side of the instrument, as displayed on the photo, then by means of a small flat screwdriver, rotate the selector toward right to set it to 115 Vac.
On the Main Switch block are located 2 fuses, which are easily accessible to be replaced. To replace the fuses use the following procedure: • Locate the fuse box • By
a flat screwdriver, push down the small tongue that keeps the box inside the switch block and pull it out using a small pliers (if necessary).
• Remove
the fuse box completely
• Change
both fuses (*)
• Insert
the fuse box inside the Main Switch block again.
(*) The fuse which is placed in appliance inlet should be replaced by T 2,5 A 250 V dimensions 5x20 mm for a power of 230Vac and by T 3,5 A 250 V dimensions 5x20 mm for a power of 110Vac.
Page 12 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
6
SYRINGE CHOICE
ROLLER20LC is supplied normally with the CBC syringe designed to work with ordinary BC \ Greiner test tubes. It is possible, however, to require the analyser with installed other kind of syringe like for Sarstedt or Terumo test tubes.
Photo 1
Photo 2
Photo 3
CBC syringe.
Sarstedt syringe
Terumo syringe
Code SI195.021
Code SI195.022
Code SI102M23
Page 13 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
7
KEYBOARD SPECIAL FUNCTIONS
The keyboard uses special keys that activate the choice. The keys point out not only the numerical value but even the function that activates, if pressed. The keys are: 0 - Availability Increase
To Increase the availability of credits.
1 - Rack Insertion
Used to start an analysis cycle.
2 - Washing
To clean the needle and capillary
3 - Rack Removal
To remove test tubes from the wheel.
4 - Date & Time 5 - Tech. Menu
Described in the Technical Manual.
6 - Electronic calibration
Used to run the instrument control by Latex.
7 - RX Data Waiting
Not used
8 - Operat. Menu 9 - Tank Replace REPRINT
To activate the printing of the statistical data
PAUSE
Reserved to technical service
MAIN MENU
Page 14 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
8
SWITCH the ANALYSER ON
Verify if the front door is closed and light the instrument pushing the switch set on the instrument rear side. Wait at least 20 minutes before starting the analysis to allow the temperature to reach t he 37° C stability. The printer is going to printed out: ROLLER 20
IT ver.
4.xx
6.51C UK ver. ROLLER 20 SN. xxx GG/MM/AAAA HH:MM ======================
Identification message of the installed software version Instrument Serial Number Date & Time
Availability ESR 20000 A message as above is printing while the instrument generates two acoustic beeps. All mechanical parts movements will be checked and the instrument initialized automatically. After that, the printer is going to print out: ====================== 8 - MENU ====================== TEMP.
37.0
Nominal temperature of work.
Any test tubes and w ashing tubes still in the wheel, must be removed at the aut omatic requesting time.
WASTE TANK LEVEL MESSAGE
9
An added function in the software, calculates the volume of liquid wasted into the waste tank after the analysis. The number of analysis that can be processed without emptying the waste tank is fixed to 1000. A counter is increased after each processed sample. If the alarm threshold is reached, the following message will be printed-out while…. =============== Waste Level detected EMPTY the tank. =============== … the yellow led set in the left side of the keypad is blinking and the display is showing the message like: 0 - NOT EMPTY
1)
Open the front flap and empty or replace the tank.
1 - EMPTY
2)
Press key "1" to turn the counter to 0
To disposal the waste tank content, foll ow t he standard safety p rocedures the laboratory works with. Note: 1) If it is not necessary emptying or replacing the tank, press 0 to close the procedure without resetting the counter. 2) Pressing key 9 at MAIN MENU it is possible recalling the displayed options as described above.
Page 15 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
10
MAIN MENU MAIN MENU choose
Pressing key 8 (Operat. Menu ), the display is going to show the following options:
1 - To pri nt Menu 2 - To mix
Pressing key 1, the printer is going to print-out a list as below:
012345679REP -
AVAILABILITY MEASURE WASHING RACKS EXTRACTION DATE & TIME TECHNICAL MENU CALIBRATION EC RS 232 RX DATA TO CHANGE TANK STATISTICAL DATA
0. Is to increase the availability of test 1. Is to start a new analysis cycle 2. Is to start a new washing procedure 3. Is to remove test tubes from the instrument 4. Is to change Date & Time 5. Is to access Technical Menu (the password is required) 6. Is to perform an instrument check by a Latex Control kit. 7. No longer in use. 9. Is to reset the alarm counter of the wasted liquid. REP. Is to prints out the statistical data a- Latex Control trend plots b- Blood trend plots c- Cumulative average ESR. d- Cumulative standard deviation. e- ESR average of the working day. f- Standard deviation of the working day. g- Washing data
Pressing key 2, the mixing function is going to be activated. The inserted samples will be mixed without analyzing them. Open the front door and insert the sample tubes following the displayed instructions. This function becomes useful if a hematology mixer is not available during the comparative proofs between the instrument and the method used in the laboratory. The inserted samples are mixed by means of the same number of rotations programmed for the analysis, and at the end they are kept mixed through a rotation on each 10 seconds until ENTER key is pressed.
Page 16 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
11
TO CHANGE DATE & TIME
This procedure can be executed pressing key 4 – Date & Time from MAIN MENU The following message will be shown:
DD/MM/YYYY setup
where DD=Day, MM=month, YYYY=Year
DATE
If some digit has to be changed, press CLEAR and type the correct date. Press ENTER, then, to bypass the time field. If time is correct, press ENTER key twice to go back MAIN MENU. To change the time press ENTER from the date. At this point the displayed message is:
HH:MM
where HH=hour, MM=minutes
setup TIME If time is correct press ENTER key. If some digit has to be changed, press CLEAR and type the correct TIME in whole time format.
Page 17 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
12
PAPER LOADING PROCESS INTO THE PRINTER
The described pr ocedure has to be done at ins trument 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 more paper if it is necessary.
Photo 4 CUSTOM PLUS
on the printer to obtain
Photo 5 CUSTOM PLUS II
Note: If the paper roll is sold with the code 195.800, its exhaustion is indicated by a red colour line painted on the last part of the strip. Please remember that from the initial appearance of colour the strip can guarantee the printing of 60 samples and therefore it is suggested to replace the roll immediately after finishing the analysis cycle or before starting a new one.
Page 18 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
13
SMART CARD TO INCREASE CREDITS
13.1 AVAILABILITY TEST INCREASING The instrument works with credits of test which can be loaded by means of a Smart Card ALIFAX supplies. The amount of credits the customer can require is between 1000, 4000, 10000, 20000. By this software version, the Smart Card and process to load credits are managed by the instrument which includes options printed-out on paper during the loading process activation. If, on MAIN MENU, key 0 is pressed, the printer will be able to print-out a menu as reported below: 1 – increase AVAIL. 2 – smart status 3 – print log smart
To increase credits by ordinary Smart Card, press key 1, insert the card into the reader slot and then press ENTER when “SM FST AREA OK” (the 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.
AVAILABILITY ESR 1995 New personalization ALIFAX SPA SMVALUE 1000
To check the card press 2. The instrument displays the request to insert the card into the slot. Insert the card and wait. The display will show information according to the Smart Card status. It could be : Used Card Press ENTER
Not used Card Press ENTER
…...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.
Used card Sn 0 Contain xxxxxx tests Download date 31/03/2010
Not used card Sn 0 Contain xxxxxx tests Manufacturing year 2000
To get the SMART CARD LOG press 3. The printer is going to print-out the history of all loadings been executed; e.g: ----------LOG SMART CARD---------Date Aut I Card Aut. A Sn 31/03/10 1995 1000 2995 0 25/03/10 200 1000 1200 0 31/03/10 1000 10000 11000 0
Year 2000 2000 2000
Note: When key 1 (Rack in sertion ) is pressed and the present availability is between 0 and 1000, the request to increase the availability will be recalled automatically. If the availability is 0 or negative, the instrument will not allow the execution of new analysis; until new credits are loaded.
13.2 UNIVERSAL CARD Recently Alifax has introduced a new Smart Card which is an evolution of the previous ones. It is designed to work with all ESR line devices ALIFAX developed. The procedure to work with this kind of card is similar than the previous ones and sale codes and amount of credits stored is similar too.
Photo 6 Page 19 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
13.3 SMART CARD ERRORS During the loading process, incorrect procedures or possible malfunctions can be caused by: 1. …the smart card not inserted properly or inserted upside-down 2. …the card contact plaque not set to the internal side of the instrument. 3. …the reader contacts don’t allow the card to be read.
Error messages could appear on display lik e: OUT STD XXXX Press ENTER
it means the card has a number of tests that is outside the normal ranges: 1000 – 4000 – 10000 – 20000
SM FST AREA NOK Press ENTER
it means the inserted card has a personalization that doesn’t match the instrument personalization and so the instrument rejects that card.
Page 20 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
14
USE OF PAEDRIATIC TEST-TUBE
The insertion of pediatric test-tube in the wheel requires the use of adapter. The adapters Alifax can supply are not universal but designed in three different measures for SARSTEDT TAPVAL VACUTAINER
(Photo 7) (Photo 8) (Photo 9)
The sale codes of the adapters are: SI195595 (adapter for SARSTEDT test-tube) SI195590 (adapter for TAPVAL test-tube) SI195593 (adapter for VACUTAINER test-tube)
Photo 7
Photo 9
Photo 8
Note: Other kind of pediatric test-tube cannot be used because of lack of adapter.
Page 21 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
15
TEST TUBES INSERTION READING THE ID CODE (by External Bar Code Reader)
MAIN MENU choose
Press key 1 which will activate:
BCR, ENTER o measure START
1.
Open the front door.
2.
By the External Bar Code Reader plugged to the “SERIAL PORT 1” plug, read the code of the label applied on a patient test tube. The confirmation to have accepted that specimen to carry out the analysis is given by the rotor rotation. It rotates to the next position and wait for the sample tube insertion while the display shows the following information…
yyyyyyyyyy = patient identify code (ID)
yyyyyyyyyy measur e START
X
X = rotor position for the test tube insertion
…followed by this message after having inserted the test tube in the assigned location:
BCR, ENTER or to end START 3.
Read the successive code and follow the instructions from point 2.
The wheel accepts from 1 to 18 sample test tubes, then, at the end of the insertion, the analyser waits for the START key pressure and after closing the door, the rotor is going to rotate in order to move the wheel to the 19th position. The analyser waits for the first insertion of the two test tubes with contains distilled water inside. The software is designed to activate their use at the end of the pre-set time to run an automatic washing. At the requesting time:
i. ii. iii.
Ins.
wash.
n°1
Open the door and insert the first tube with distillate water into the 19th position. Press ENTER key and insert the second washing tube in the 20th position Press ENTER key again and close the door.
The mixing process is going to run automatically followed by the measuring phase.
Note: The analyser requires these two test tubes: 1. 2. 3.
at the first analysis cycle of a new day assuming the analyser has been turned off for the night. at the first analysis cycle after turning the analyser off and then on. at the first analysis cycle after an automatic washing executed.
The analyser does not require these two test tubes again whether: 1. 2.
the capillary is cleaned by a manual previous washing procedure. a new analysis cycle is run before the end of the pre-set time calculated from the end of the analysis cycle since water of these two inserted test tubes has not been aspirated.
Page 22 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
Extra NOTE If the identity code label read by the scanner does not match with the displayed one (scanner error) it is possible to erase the wrong code pressing CLEAR key and repeat the reading. If an automatic washing is performed between the end of the analysis cycle and the beginning of the successive one because the washing preset time is expired, at the successive analysis cycle the washing tubes will be required again. If the automatic washing is not activated between the end of the analysis cycle and the beginning of the successive one, at the successive analysis cycle the washing tubes will not be required. If the analyzer is switched off at the end of an analysis cycle and then on, at the successive analysis cycle and at the end of the loading process of the sample test tubes, the two test tubes for wash will be required. When the analyzer is off, in-fact, it loses all the information concerning the inserted test tubes.
Page 23 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
16
TEST TUBES INSERTION AFTER HOST INTERROGATION MAIN MENU choose
Press key 1 which will activate:
BCR, ENTER o measure START
1.
Open the front door.
2.
By the External Bar Code Reader plugged to the “SERIAL PORT 1” plug, read the code of the label applied on a patient test tube. If the instrument is connected to the informatics system, generally called LIS or HOST at every ID code read, ROLLER 20 interrogates HOST to verify if that specimen has to be analyzed or not. In the positive case, the rotor rotates to one position to allow the test tube insertion to the assigned wheel position. The display is going to show the following message
yyyyyyyyyy Insert
X
Note: yyyyyyyyyy points out the patient code (ID). X identifies the rotor position for the test tube insertion.
Insert the test tube into the assigned location and repeat the procedure from point 2 for the successive test tube. For the negative case the rotor does not move. The instrument gives three acoustic beeps and the following message displayed for two seconds…
Not request measur e START
X
Note: X This number identifies the wheel position for the sample tube insertion
…followed by
BCR, ENTER o measure START 3.
Discard that test tube and repeat the procedure from point 2 for the successive test tube. If the patient ID read through the EBCR does not find its correspondence code in the patient list of HOST, the instrument analyzes that specimen in any case. The following information, therefore, will be displayed for a couple of seconds…
Not find measur e START
Note: X
X This number identifies the wheel position for the sample tube insertion
…followed by
BCR, ENTER o measure START Press ENTER to assign an auto-generated code and insert the test tube into the assigned location. Repeat the procedure from point 2 for the successive test tube
Page 24 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
The wheel accepts from 1 to 18 sample test tubes, then, at the end of the insertion, the analyser waits for the START key pressure and after closing the door, the rotor is going to rotate in order to move the wheel to the 19th position. The analyser waits for the first insertion of the two test tubes with contains distilled water inside. The software is designed to activate their use at the end of the pre-set time to run an automatic washing. At the requesting time:
Ins.
wash.
n°1
Open the door and insert the first tube with distillate water into the 19th position. Press ENTER key and insert the second washing tube into position 20th position Press ENTER key again and close the door.
i. ii. iii.
The mixing process is going to run followed by the measuring phase.
Note: The analyser requires these two test tubes: 1. 2. 3.
at the first analysis cycle of a new day assuming the analyser has been turned off for the night. at the first analysis cycle after turning off and then on the analyser. at the first analysis cycle after an automatic washing done
The analyser does not require these two test tubes again whether: 1. 2.
the capillary is cleaned by a previous manual washing procedure. a new analysis cycle is run before the end of the pre-set time calculated from the end of the analysis cycle since the water of these two test tubes has not been aspirated.
Extra NOTE If the identity code label read by the scanner does not match with the displayed one (scanner error) it is possible to erase the wrong code pressing CLEAR key and repeat the reading. If an automatic washing is performed between the end of the analysis cycle and the beginning of the successive one because the washing preset time is expired, at the successive analysis cycle the washing tubes will be required again. If the automatic washing is not activated between the end of the analysis cycle and the beginning of the successive one, at the successive analysis cycle the washing tubes will not be required. If the analyzer is switched off at the end of an analysis cycle and then on, at the successive analysis cycle and at the end of the loading process of the sample test tubes, the two test tubes for wash will be required. When the analyzer is off, in-fact, it loses all the information concerning the inserted test tubes.
Page 25 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
17
TEST TUBES INSERTION (MATCHED WITH PATIENT ID CODE TYPED MANUALLY)
MAIN MENU choose 1.
Press key 1 which will activate:
BCR, ENTER o measure START
Open the front door Type the specimen ID code from yyyyyyyyyy the numerical keys. If the typed code is incorrect, press CLEAR to measure START erase digit by digit and type the right code .
2.
Note: yyyyyyyyyy points out the patient code (ID).
Press ENTER to confirm.
3.
The wheel is going to rotate to the next position to allow the test tube insertion 4.
Insert the test tube into the assigned location
yyyyyyyyyy Insert
5.
Note: yyyyyyyyyy points out the patient X
code (ID). X identifies the rotor position for the test tube insertion.
Repeat this procedure from point 2 to 4, if others samples test tube have to be inserted.
The wheel accepts from 1 to 18 sample test tubes, then, at the end of the insertion, the analyser waits for the START key pressure and after closing the door, the rotor is going to rotate in order to move the wheel to the 19th position. The analyser waits for the first insertion of the two test tubes with contains distilled water inside. The software is designed to activate their use at the end of the pre-set time to run an automatic washing. At the requesting time: i. ii. iii.
Ins.
wash.
n°1
Open the door and insert the first tube with distillate water into the 19th position. Press ENTER key and insert the second washing tube into the 20th position Press ENTER key again and close the door.
The mixing process is going to run automatically followed by the measuring phase.
Note: The analyser requires these two test tubes: 1. at the first analysis cycle of a new day assuming the analyser has been turned off for the night. 2. at the first analysis cycle after turning off and then on the analyser. 3. at the first analysis cycle after an automatic washing done The analyser does not require these two test tubes again whether: 1. the capillary is cleaned by a manual previous washing procedure. 2. a new analysis cycle is run before the end of the pre-set time calculated from the end of the analysis cycle since the water of these two test tubes has not been aspirated.
The extra note is similar t han on the pr evious cases as wri tten on p age 22 Page 26 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
18
TEST TUBES INSERTION (MATCHED WITH AUTOGENERATED ID CODE)
If a test tube contains blood of a patient but it is not marked by the patient ID code, the analyzer can assign one progressive number by itself:
MAIN MENU choose 1.
Open the front door
2.
Press ENTER key
Press key 1 which will activate:
yyyyyyyyyy insert
BCR, ENTER o measure START
Note: yyyyyyyyyy points out the autox
generated patient code (ID).
X points out the rotor position for the test tube insertion The wheel is going to rotate to the next position to allow the test tube insertion. 3.
Insert the test tube in the assigned location and repeat the procedure from point 2 to 3, if others samples test tube have to be inserted.
The wheel accepts from 1 to 18 sample test tubes, then, at the end of the insertion, the analyser waits for the START key pressure and after closing the door, the rotor is going to rotate in order to move the wheel to the 19th position. The analyser waits for the first insertion of the two test tubes with contains distilled water inside. The software is designed to activate their use at the end of the pre-set time to run an automatic washing. At the requesting time: i. ii. iii.
Ins.
wash.
n°1
Open the door and insert the first tube with distillate water into the 19th position. Press ENTER key and insert the second washing tube in position 20th position Press ENTER key again and close the door.
The mixing process is going to run automatically followed by the measuring phase.
The analyser requires these two test tubes: 4. at the first analysis cycle of a new day assuming the analyser has been turned off for the night. 5. at the first analysis cycle after turning off and then on the analyser. 6. at the first analysis cycle after an automatic washing done
The analyser does not require these two test tubes again whether: 3. the capillary is cleaned by a manual previous washing procedure. 4. a new analysis cycle is run before the end of the pre-set time calculated from the end of the analysis cycle since water of these two test tubes has not been aspirated.
The extra note is similar t han on the pr evious cases as wri tten on page 23
Page 27 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
19
PRIMING PROCESS and MEASURING PHASE
“Priming” is a process which has the purpose to remove water particles from the capillary due to a previous washing procedure done and to avoid diluting of blood in the reading cell at the first measuring phase. The priming procedure consists in aspirating 87µl of blood from the 1st and then from the 2nd sample test tube assuming at least two of them have been loaded in the wheel. If it has been inserted only one, the two aliquots of blood of 87µl each are withdrawn from that test tube. After loading the test tubes in the wheel and starting the analysis cycle, assuming the capillary has been cleaned by a washing procedure executed previously, the analyzer splits up the time of the mixing process to carry out priming. At the end of it and if the priming has been done unsuccessfully, a washing procedure will start automatically aspirating water from the 19th and 20th inserted test tubes. The instrument, then, is going to repeat the priming and if it is done successfully the analyzer is able to go ahead executing the second half of mixing followed by the measuring phase. Otherwise if it is done unsuccessfully the analyzer is going to activate and display the request of a new automatic washing.
ENTER Washing CLEAR to end Pressing ENTER, the wheel is going to rotate to the 19th position. It will require to remove the inserted test tube in order to refill the position with a new test tube filled with distilled water. Upon inserted a new test tube into the 19th position and pressed ENTER again, the wheel is going to rotate to the 20th position for the second washing test tube insertion. After inserting the second test tube, press ENTER and close the door. The rotor is going to rotate again to run the new automatic washing procedure moving the wheel to the 19th position and then to the 20th. All this processes will be repeated, until the priming is executed successfully; except when CLEAR key is pressed. The instrument is able to start mixing again followed by the measuring phase of each inserted sample test tube, if the priming has been executed successfully. If during the measuring phase the analyzer gives 3 consecutive “NF”, which means no blood flow, the instrument will carry out a washing procedure automatically aspirating water from the 19 th and 20th test tubes. The mixing cycle will start again, for the washing done successfully, and then the instrument will jump the 3 sample tubes that have caused the malfunctioning. Another “priming” process will be run again aspirating blood from the successive sample test tube and eventually, with the priming done successfully, the cycle will go ahead without others requests.
Note: If a sample tube falls down during the mixing cycle (the tube sensor checks if the samples are inserted) the instrument gives an error message printing these result as CM. The analytical cycle stops if 3 successive missed sample tubes will be detected.
Page 28 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
20
ESR RESULTS PRINTED OUT ON PAPER
For each analyzed specimen, the printed out results will have a format similar than: Example of format with details printing option enabled:@ ============================ Tube n° 1 04/11/2011 15:07:13 ID 847297429742 ESR 16 Tube n° 2 04/11/2011 15:07:31 ID 987892722244 ESR 2 Tube n° 3 04/11/2011 15:07:50 ID 654754626728 ESR 9 Tube n° 4 04/11/2011 15:08:08 ID 986348232467 ESR 30 ============================ Example of format with printing details option disabled @ 04/11/2011 15:07:13 ============================ ID 847297429742 ESR 16 ID 987892722244
ESR 2
ID 654754626728
ESR 9
ID 986348232467
ESR 30
Example of possible results: 04/11/2011 15:07:13 ============================ ID 986348232467 ESR 30 * ID 986255542424
ESR C.M.
ID 986242242333
ESR NF
ID 234245646567
ESR NR
ID 242448482472
ESR 120#
============================
An asterisk (*) printed-out next by the ESR result, points out that this particular sample has a low value of hematocrit (20 % roughly). CM (Sample missed) message can occurs when the syringe have not hit with the sample test tube. Probably dropped down during mixing. NF (No flow) message occurs when blood is not present in the reading cell at the measuring phase. NR (No reliable) message occurs when during the measuring phase the red cells of the specimen cannot aggregate between them and accordingly the result has not been calculated correctly. 120 This means the real ESR is higher than 120mm/h but since the reading scale ends with 120mm/h, the instrument can prints out instrument cannot prints out a value higher than 120.
@ Note: To enable or disable the details printing call the technical service. # Note: To be printed out, the limits () have to be enabled in the appropriate field available in the technical menu. To do that call the technical service. Page 29 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
21
RESULTS REPRINTING
At the end of the analysis cycle the instrument is going to generate acoustic beeps while the following message displays:
1- REPRINT
1= it reprints detailed information of all the analysed specimens.
2- REPRINT ESR
2= it reprints the patient ID code matched with the ESR result only of all the analysed specimens.
followed by
3- SEND TO HOST ENTER EXIT
3= it sends the result string of all the analysed specimens to host computer. ENTER= is to exit from the analysis cycle. The test tubes extraction will be required before going back to MAIN MENU.
Note: The REPRINT options are displayed consecutively and in loop.
22
TEST TUBES EXTRACTION
After turning the analyser on and the initialization phase, the wheel is going to rotate to all positions, one by one automatically, in order to identify if test tubes are still inserted in it. If it identifies a test tube, the display will point-out it. Open the front door and remove it from the wheel. The wheel, then, is going to rotate to find out an hypothetic successive test tube automatically. If the analyser is on MAIN MENU, any test tube still present in the wheel can be removed, with the exception of the two inserted for the automatic washing assuming these were not been used yet, pressing key 3 (Rack Removal). The LCD display shows this message:
wait positioning and after a few seconds
Extract CLEAR to end Open the front door and one by one extract the inserted test tubes and close the door.
Page 30 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
23
MANUAL WASHING PROCEDURE
This procedure is designed to clean the complete capillary tubing and so to set it free from blood or Latex residuals. Since along the working life, blood, water and latex flow inside the Teflon capillary tube, particles of them tend to hang on the internal walls of it. This fact, accordingly, increases the capillary opacity reducing the reading scale of the ESR values. In order to maintain the capillary cleaned and to increase its own working life, the operator should carry-out washings in different ways as described below:
23.1 WASHING USING 2 TEST TUBES Despite the software has been designed to activate automatic washings, the user can carry out washings manually. But, while for the automatic washing, which is activated at the end of the pre-set time, it is required two test tubes filled for ¾ with distilled water and put in the 19th and 20th position of the wheel, the manual washing foresees two test tubes filled for ¾ with distilled water too but put in the 1st and 2nd position. Press key 2 (Washing) on MAIN MENU, open the door and then insert the 1st test tube in the first position of the wheel and press ENTER, insert the 2nd to the second position and press ENTER twice. Close the door and wait for the end of this process.
23.2 WASHING USING 3 TEST TUBES At the end of the working day, the execution of this option has the purpose to maintain the needle and capillary cleaned during the night and any residual of blood particles wet increasing, therefore, the capillary working life. The residuals will be removed easily at the beginning of the new day. To activate the procedure, it is required 3 test tubes filled for ¾ with distilled water. They have to be inserted in the first three positions of the wheel after pressing key 2 (Washing) from MAIN MENU. The needle will aspirate the content from the first and second test-tubes completely and partially from the third test-tube remaining inside it while the analyzer is displaying the message “ ROLLER20 off – ENTER cont inue ”. The user can chose to continue with the ordinary activities pressing “ENTER” or to switch the instrument off. After switching on the instrument which should be at the beginning of the new working day, the needle is going to exit from the third test-tube and the pump is going to rotate to empty the needle and capillary. Water and any wet residual particles of blood will be discarded into the waste tank.
23.3 WASHING PROCEDURE FOR MAINTENANCE (useful even to unlock the needle and capillary ) For a good maintenance of the instrument and in case the needle and/or capillary are obstructed, carry-out this procedure using distilled water and Sodium Hypochlorite (5% of dilution). The frequency of use can be calculated according with the number of analyzed specimens. E.g.
once per 2 weeks up to 60 specimens per day once per 1 weeks for over 60 specimens per day
The procedure is: 1. Prepare two test-tubes filled 3/4 with distilled water and press key 2 (Washing) to start. Put them in the 1st and 2nd position of the wheel and wait for the end of the procedure. 2. Prepare one test-tubes filled 3/4 with Sodium Hypochlorite (5% of dilution) and one test tube filled 3/4 with distillate water. Press key 2 (Washing) to start and put the 1 st test tube into the 1 st position of the wheel and the 2nd test tube in the 2nd position. Close the door and wait for the end of the procedure. 3. In order to rinse the capillary, prepare two test-tubes filled 3/4 with distilled water and press key 2 (Washing) to start again. Put the test tubes in the 1st and 2nd position of the wheel, close the door and wait for the end of the procedure.
23.4 WASHING PROCEDURE IN CASE OF DAILY CONTROLS BY MEANS OF LATEX KIT The washing procedure in case of daily controls by means of Latex kit is the same of the previous described procedure (washing procedure for maintenance ). It has to be used every time before starting the control process in order to carry-out quality control of the instrument (QC).
Page 31 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
At the end of each washing procedure, the software is going to report its value matched with the suffix T100 . E.g.
========================= T. 100 (3503) MAX Sens. 3574 T100 3503 pt MAX Sens. 3574 T100 3503 pt Ch2
S1 3574
S2 3574
14/11/2005
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.
=========================
1 3574 2 3574 Washing executed Wt 3574 *** PHOTOMETER OK ***
Read values report from the first and second tube.
At every incorrect washing procedure, the printed-out result will be 2048 and the software will generate Z error. A new washing procedure will be requested. If the T. 100 fields reports a value of 2960 roughly, it means that the tubing is going to be opaque. In this case try to carry-out the WASHING PROCEDURE FOR MAINTENANCE in order to reduce the opacity of the capillary. The value then should increase to 3505. If it remains closed to 2960, the technical service should be called in order to replace the complete tubing.
Note: T. 100 value is reported on flag list which can be obtained in this way: 1. turn the instrument on 2. within two seconds after hearing two beeps sounds, press REPRINT key
Page 32 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
24
LATEX FOR QUALITY CONTROL PRESENTATION.
24.1 QUALITY CHECK USING LATEX CONTROL KIT Latex Controls kit (sale code SI 305.100-A for 6 Controls or SI 305.300-A for 30 Controls) is a valid tool to verify the analyser functioning and so to keep it monitored during its whole working life. Before starting the Control process, the analyser can require a washing procedure. In this case, the operator should carry-out the washing procedure as the instruction at MANUAL WASHING PROCEDURE chapter explains. At the end of the Control process, the printed out results are three ESR values: the first one is closed to 9 mm/h roughly, the intermediate one is closed 20 mm/h roughly and a high level is closed to 60mm/h. The obtained results should be compared with the values reported on the label, second table applied on the kit package. If the obtained results are into to the expected ranges, it means that the analyser is calibrated correctly. On the contrary, if one or more results are out of the expected ranges, it is recommended to call the Technical Service for a functional verification and calibration of the analyser. At the Control process time, if the external scanner is able to read all three Latex codes, then the mixing process will start automatically. At the same time the read codes will be stored into the chip memory of the analyser. The read codes, then, are maintained stored in it until the number of the executed Controls is over the scheduled ones. At the successive attempt to carry-out a new Control process, the instrument is going to empty the test-tubes completely discarding the residual amount of Latex still present into them. By this way, Alifax can guarantee the quality of the product to a maximum of 6 Controls and to a maximum time of 6 weeks from the first Latex aspiration.
To run a Control pr ocedure: (1) Carry-out a washing procedure: a. b.
Execute a first washing procedure (press key 2 at MAIN MENU) using 2 test tubes filled for ¾ with distilled water. The tubes have to be loaded into the position 1 and 2 of the wheel. Execute a second washing procedure (press key 2 at MAIN MENU) using one test tube filled for ¾ with Sodium Hypochlorite and one test tube filled for ¾ with distilled water. The first test tube has to be loaded into the position 1 of the wheel, the second into the position 2 of it.
(2) Verify that the analyser is on Main Menu, with the following message on display:
MAIN MENU choose (3) To start the Latex Control procedure press key 6 (Electronic Calibration). If the instrument needs a washing again, the following message is displayed…
Make a Washing
Follow the instructions described above at point (1) “ a” .
…otherwise, or when the washing is completed, the following message is displayed.
1 -STD Procedure 2 Change STD (4) Press key 1 to start, open the door and insert one test tube containing at least 3 ml of distilled water into the first position of the wheel. Press ENTER so that the wheel is going to rotate to the second position. (5) By the external scanner, read the label of the first Latex test tube marked as number 2, insert the test tube into the second position of the wheel and press ENTER. (6) Repeat the same process for inserting the second and third Latex test tubes and marked respectively 3 and 4 into the 3rd and 4th positions of the wheel, pressing ENTER after each inserted tube. (7) Insert the remaining two test tubes containing at least 3 ml of distilled water into the positions 5th and 6th of the wheel pressing ENTER after each inserted tube. (8) Close the door. The analyser is going to start mixing which takes about one minute and half to be completed.
MIXING
Note: if instead of mixing appears the message “STD N X xxxx ” it means that the scanner have not read the code of one or more testtubes. In this case, type the code as described in the next chapter. Page 33
ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
At the end of mixing, the needle is going to aspirate water from the first test tube and then a little amount of Latex from the second in order to carry out priming. After priming done successfully, the analyser is going to aspirate Latex again from the same test tube and then from the others two for the analysis process. Afterwards the analyser is going to aspirate water from the successive last two test tubes in order to rinse the capillary. During the water and Latex aspiration the display shows some messages like those reported below as example:
A 1023 B 960 T100 3529 MEASURE wait
related to the first washing
A 1023 B 960 T100 3529
is related to the last tubes of washing
appears during the latex analysis
At the end of the aspiration of the last test tube, the printer is going to print out the latex an alysis report. An example is reported just below:
Message
Meaning
1543 921507 0921 921507 0566 921507 Lot n° 1921 KIT 507 ======================== 10/11/2011 11:03:12 Washing Executed ======================== *** PHOTOMETER OK *** ======================== FDF 0,9909 ======================== 10/11/2011 11:04:47 Washing Executed ======================== *** PHOTOMETER OK *** ======================== FDF 0,9920 ========================
First Latex test tube marked n°2 Second Latex test tube marked n°3 Third Latex test tube marked n°4 Lot and kit number
Notes
Reference values LEVEL 2 = 10 ( 7 : 13) LEVEL 3 = 27 (22 : 32) LEVEL 4 = 80 (69 : 82) =========================
The printed values are the same reported on the label of the box as reference on the Latex Control kit.
Photometer Param.
They are the following:
ROLLER 20
Type
Date and time of the washings process aspirating water from the first test tube. They are printed out together with the message that confirms the correct functioning of the photometer. Water compensator value Date and time of the washings process aspirating water from the fifth test tube. They are printed out together with the message that confirms the correct functioning of the photometer. Water compensator value.
UK ver. 6.51C ROLLER20 SN. 1640 FDF 0,9920 T100 3618 BoosterY 1.0704 MFACT 1.0704 Offset channel 125 ========================== ESR LEVEL 2 = 10 ESR LEVEL 3 = 26 ESR LEVEL 4 = 79 ==========================
of the instrument Software version Serial Number (SN.) Water compensator and values Gains value Offset value. The
final values given from latex controls, which should stay within the ranges of the reference values.
The results of latex controls must be within the range pointed out from the printing. This range is also reported in Table 2 on the kit package. The controls results ESR LEVEL 2 ESR LEVEL 3 ESR LEVEL 4 should be compared with the reference values of the first printing (reference values). The reference values could vary from Lot to Lot: refer to the instructions of use inserted in the kit.
When the analysis is completed, we have:
Extract CLEAR to end
Open the loading door and remove the test tubes one by one or press CLEAR to exit without removing them.
Page 34 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
24.2 RECALLED LATEX ID CODE During the second or one of the remaining four Latex Control processes, if the scanner cannot read one or more of the three codes, the user could choose to recall the code stored at the first Control process of that kit assuming the lot number is not expired. E.g.
At display
Insert value STD N 2
press ENTER basically and the stored code will be confirmed automatically.
Memo xxxx xxxxxx
press ENTER basically and the stored code will be confirmed automatically.
Memo xxxx xxxxxx
press ENTER basically and the stored code will be confirmed automatically.
Memo xxxx xxxxxx
Insert the test tube and press ENTER
At display
Insert value STD N 3
Insert the test tube and press ENTER
At display
Insert value STD N 4
Insert the test tube and press ENTER
24.3 LATEX CODES TYPED MANUALLY At the first use of a new kit and if the analyser is not equipped with an external scanner or the scanner cannot read one or more of the three codes, maybe the label is ruined, each Latex code could be typed manually before the mixing process:
At display
Insert value STD N 2
press ENTER, CLEAR and type the complete code number reported on the label, glued on the test tube marked as 2.
Press ENTER, insert the test tube in the assigned wheel location and press ENTER again.
At display
Insert value STD N 3
press ENTER, CLEAR and type the complete code number reported on the label, glued on the test tube marked as 3.
Press ENTER, insert the test tube in the assigned wheel location and press ENTER again.
At display
Insert value STD N 4
press ENTER, CLEAR and type the complete code number reported on the label, glued on the test tube marked as 4.
Press ENTER, insert the test tube in the assigned wheel location and press ENTER again.
Page 35 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
25
QUALITY CONTROL TOOLS PRESENTATION
In order to carry out internal Quality Control, the ROLLER 20LC software includes a series of tools which report and plot the instrument performances. Such control tools are the following:
1. INSTRUMENT QUALITY CONTROL USING LATEX CONTROL KIT: These plots come from Latex kit (code SI 305.100 for 6 tests or code SI 305.300 for 30 test) designed expressly for the TEST1 family analysers (TEST1, Roller10-20PN, Roller20LC). 2. HEMATIC STATISTICAL DATA PRINTOUT. The graph, which takes into account the population who refer to the lab, is generated by black and white circles which represent the cumulative and daily averages of the ESR results. At the beginning of the instrument working life, the Quality Control system stores values, represented by the circles on the graph, of specimens analysed during the last 30 days. Subsequently, the complete plot will be updated automatically. 3. ESR VALUES DISTRIBUTION PRINTOUT There are four different plots divided in different ranges: two of them points out ESR results from 2 to 120 mm/h (cover the complete range) and the other two points out ESR results from 2 to 30 mm/h which in Italy they are considered not pathologic results. This tool is useful to each lab to define a referent cut-off and split-up pathologic results from the no pathologic ones. 4. WATER DATA PRINTOUT By a black point for each day, this wants to report the daily average of the photometrical check done during each washing procedure.
Page 36 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
25.1 QUALITY CONTROL BY MEANS OF LATEX CONTROL KIT At the end of each Latex Control process, each obtained result could be represented into a Quality Control plot trough black circles. The printer, therefore, can print out it for a statistic analysis. After pressing REPRINT key from "Main Menu ", the following message is going to be displayed: Press key 1, to display the next message:
STATISTICAL DATA ESR STD RATE (1)
Press key 1 (TREND ESR) to print out the following graph Press key 2 (TREND FACT) to print out the successive graph:
1 - TREND ESR 2 - TREND FACT
2
40
80
∗
ο
0
∗
ο
0
120
ESR
∗
ο ∗
0
ο
0
∗
ο
0
∗
ο
0
∗ ∗ ∗ ∗
-20
ο
0
ο
0
ο
0
ο
0
-10
1
+10
+20
DEV% ∗
∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗
DEV. ST. 16,15 CV% = 8,05
This graph shows the trend of the three Latex Controls values which checks have been performed along the working days. The first series of symbols (* ° o) lined up on the top line, represents the first analysis of Latex Controls, while the last one on the line at the bottom represents the results of the last check done. Thought this graph it is possible to see the variations in trend of the analyser that can be assessed in qualitative but not in quantitative way. Furthermore, in case of lot change, if the new lot is characterised by different values from the previous one, the obtained results will appear shifted on the graph, like the 1st four series of symbols in the aside example. In this case, it is suggested to monitor the trend of the new Latex Control lot for few days and to verify the consistency of the results obtained compared to the first reading without comparing them to the previous lot.
Explanation: 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 t he 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 i nside 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.
Page 37 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
25.2 HEMATIC STATISTICAL DATA PRINTOUT The internal Quality Control program prints out the statistical data relative to the analysis gathered day by day and those relative to results cumulated from the beginning of the instrument working life. This option can be considered as an analytical contr ol based on the “ population of samples” , and assumes the role of instrument check . If the analytical performances of the instrument is reliable and if we take into account a sufficient high number of samples, (6000 roughly) the ESR mean value should not oscillate by means of a significant manner. Press REPRINT key on MAIN MENU to access into Q.C. After displaying a first option this message comes in streaming:
Press key 2 to activate the printout of the graph which represents
STATISTICAL DATA M. (2) Sp. (3) W (4)
the behaviour of the ESR mean values.
Printout of ESR MEAN value in th e FULL RANGE (2-120 mm/hr) (1-1) 5
Samp. n. 15
Where:
ww 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
● STD ○ CV% ●
○
●
● ○
ww = represents the number of samples considered (ESR range 2-120 mm/hr) xx.xx = represents the cumulative mean ESR value
●
○
yy.yy = represents the ESR daily mean value zz.zz = standard deviation of cumulative mean ESR value
●
vv.vv = standard deviation of daily mean ESR value
○
● ○ ● ○ zz.zz
kkkk
vv.vv
kkkk
cc.c
cc.c = CV% of the cumulative mean ESR value kkkk = total samples processed
A representative of patient population referring to the same lab, should generate a constant ESR mean value. This is particularly significant increasing the daily analysis. If whole data are taken into account from the first installation, it can be deduced that the mean value for all these samples tends to reach its final stable point when more samples are cumulated, thus giving a reference final value for that population (cumulative mean ESR value).
Page 38 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
Comparing the daily mean ESR value of all patients with the cumulative mean ESR value, the reliability of the instrument can be evaluated. What we can expect, is that the daily mean ESR value oscillates around the more stable cumulative mean ESR value, which represents the reference. The graphic plot can be used to see any systematic drifts from the cumulative mean ESR value. In this case the instrument reliability can be suspected.
Printout of ESR MEAN value in the NORMAL RANGE (2-30 mm/hr) (1-2)
Samp. n.
5 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
ww
15
├───┴───┴───┴───┴───┤ ● ○ ● ○ ● ○ ● ○
ww = represents the number of samples falling in the ESR range 2-30 mm/hr 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 t he 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
○
● ○
Samples kkkk STD ● zz.zz STD vv.vv ○
CV% ○
Where:
>min < max
cc.c
kkkk = total samples processed > min = min limit to be compared with the daily mean (= cumulative mean - 3 x STD of cumulative) < max = max limit to be compared with the daily mean (= cumulative mean + 3 x STD of cumulative)
What is reported in the previous pages, is more significant for the “ normal population” , In fact, the stability in time of the mean value of “normal population” is not effected by the percentage of pathological samples that can vary from day to day, influencing the variation of the Mean ESR value. Normal population of today and normal population of tomorrow will have distribution and mean ESR value very close. The “normal population“ is also , generally, the majority of population. The control of the trend with time, comparing the standard deviation of daily mean ESR value for normal range with the cumulative mean ESR value for normal range, can point out any systemic drifts of the instrument.
Page 39 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
EXAMPLE1: (1-1) Samp. n. 3744
(this is the stored number of samples)
19 29 39 |-----|-----|-----|-----|-----|
30.71
●
31.42
30.26
26.38
29.78
● o
25.19 o ……. ……
the black circle is the cumulative average
o
the white circle is the daily average of first day
cumulative average (day 1 + day 2) daily average of second day
●
cumulative average (day 1 + day 2 + day 3) daily average for third day ……………
This graph represents the last 30 days of analysis , and points out an anomalous tendency of daily averages respect the cumulative average. This can alert the user for a possible systemic error but the operator should take into account especially the cumulative average trend. The data are shown from the oldest (on the top) to the most recent (on bottom of graph). The cumulative average line becomes stable after 100 samples stored and the daily average moves around the cumulative trend line. In this way a problem on instrument could be pointed out immediately by a rapid deflection of the daily trend line and cumulative averages. The instrument is able to collect 5900 samples for calculate the average, so also large variations on daily statistics will not change in determinant way the cumulative average. On the opposite side, as soon as it reaches 5900 samples, it will discard the first 1000, coming back to 4900 samples to avoid that the cumulative average trend becomes too stable to be moved. At the end of the graph, the Standard Deviations of cumulative average and daily average are printed:
STD ● 0.30 30 Standard Deviation for cumulative data (last 30 days) STD o 4.33 30
Standard Deviation for daily average (last 30 days)
From a statistical point of view, a data can be considered stable if it stays between three Standard Deviations of the reference population. In this case, taking the last cumulative average data (29.17) and the t hree standard deviations of the daily average (4.33 x 3 = 12.99), we can say that the last daily average is in range if don't exceed the three standard deviations of the cumulative data. In this example, the lower limit is: 29.17 - 12.99 = 16.18 and the upper limit 29.17 + 12.99 = 42.16. In this case, the daily value 26.54 enters inside between the two lower and upper limits, so the instrument is working properly. Remember that if this doesn't happen, the cause should be searched on the processed samples during the day and from the kind of patients analysed (a lot of pathological or a lot of healthy patients). This first graph is referred to all the ESR results from 2 to 120, and this data can be highly instable. For this reason, also the next graph is printed out.
Number of days in the printout.
Page 40 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
EXAMPLE 2:
This second graph seems identical to the previous, but in this case the range is limited to ESR results from 2 to 30. This graph has the cumulative data more stable because specimens not affected with pathological diseases. In this case, the considered specimens are less (2351 vs. 3744 ) than those represented in the previous graph, and this is logical because the no pathologic values in Italy are surrounded from 2mm/h to 30mm/h. As on previous case, we can analyse the meaning of this graph and the results in terms of stability. (1-2) Samp. n. 2351
13.47
(this is the total number of samples processed)
5 15 25 |-----|-----|-----|-----|-----|
●
the black circle is the cumulative average
13.85
o
the white circle is the daily average of first day
13.53 13.57 14.26 ……. ……
o
daily average of second day
13.48
●
cumulative average (day 1 + day 2)
●
cumulative average (day 1 + day 2 + day 3)
o daily average for third day ……………
As on previous example, at the end of the graph, the Standard Deviations of cumulative average and daily average are displayed:
STD ● 0.09
Standard Deviation for cumulative data
STD o 1.43
Standard Deviation for daily average
As on previous case, from a statistical point of view, a date can be considered stable if stays inside three Standard Deviations of the reference population. Also in this case, taking the last cumulative average data (13.53) and the three standard deviations of the daily average (1.43 x 3 = 4.29), we can say that the daily average is in range if don't exceeds the three deviations of the cumulative data. In this example, 13.53 - 4.29 = 9.24 is the lowest limit and 13.53 + 4.29 = 17.82 is the upper limit. Looking at the daily value, 13.21 enter perfectly between the two lim its calculated, so the instrument can still be considered as just calibrated.
Page 41 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
25.3 DISTRIBUTION PRINTOUT The ESR value distribution which values come from the population who refers to the same laboratory, especially the distribution which ESR values fall down into the no pathologic range, can be assumed to be a constant in time.. This variation can be due to a variation in the number of pathological samples coming from particular wards. Keeping into account the daily ESR values distribution, it can be easily seen that the medium to high values distribution can be varied, while the distribution within the normal range remains constant. This observation guarantees that the instrument is working properly and the variation in the daily ESR mean value can be attributed to a different composition of the population referring to the laboratory. As a general rule, the higher the samples number is, the lower the variations compared to the cumulative parameters.
ESR VALUES CUMULATIVE AND DAILY DISTRIBUTION PRINTOUT Press REPRINT key on MAIN MENU to activate the statistical data printout procedure. After displaying a first option this message comes in streaming:
STATISTICAL DATA
Press key 3 to activate the following sub menu.
M. (2) Sp. (3) W (4)
STATISTICAL DATA
Press key 1 to activate the cumulative ESR distribution printout
S. (1) D. (2)
represented by (2 -1) (2 -2) tables.
Press key 2 to activate the daily ESR distributions printout represented by (3 -1) (3 -2) tables.
It works in the range 2-120 mm/hr (step 5 mm/hr) (2 -1)
Samp. n.
ww
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
Page 42 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
It works in the range 2-30 mm/hr (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
It works 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 1115 zz.zz nn … … … 106 - 110 zz.zz nn 111 - 115 zz.zz nn 116120 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
It works in the range 2-30 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
The percentage distribution of ESR values is a further control of “ constancy of population” . This control is complementary to the previous control base on the ESR mean values.
Page 43 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
25.4 WATER DATA PRINTOUT - Graph meaning The washing plot printing is to evaluate the efficiency of the ROLLER20LC photometer (CPS). The graph visualizes the average, represented by a black circle, of the washings executed daily. The instruments, normally, are regulated to give an absolute value, which is 3600, during the washing process with distilled water. This value trends to decrease during the time because biological residuals trends to deposit inside the capillary. A washing procedure for maintenance, as described in the “MANUAL WASHING PROCEDURE” chapter, should reset the photometrical signal to 3500, roughly, value again. If this value, instead decreases under 3300 or increases above 3700, the instrument will generate Z-0 error. Press REPRINT key on MAIN MENU to activate the statistical data printout procedure. After displaying a first option this message comes in streaming:
STATISTICAL DATA M. (2) Sp. (3) W (4)
NOT WASHED w 3300 xx. yyy xx .yyy xx. yyy
xx. yyy xx. yyy
xx. yyy xx. yyy
xx. yyy xx. yyy
xx. yyy xx. yyy
Where: 3500
3700
├───┴───┴───┴───┴ ● ● ● ● ● ● ● ● ● ● ●
CV% = vv.vv
Press key 4 to activate the graph printout which point out the trend of the washing mean values.
w = Represents the missing washing number xx.= Represents the washing progressive number yyy = Represents the water daily value read
vv.vv = Variation percentage coefficient.
Page 44 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
26
GAIN ADJUSTMENT
At the beginning of the instrument working life the analyzer comes to the user with the blood gain, called BoosterY, set according with the Latex calibration executed in the factory where the analyzer has been developed. At the installation time or at the end of every maintenance service, the fitter or the tech nician in charge to do maintenance should change the gain, if it is required or necessary, to balance the obtained ESR results with those obtained previously by the referent method. The fitter or technician, therefore, has to enable an option called Electronic Calibration and then it has to run an analysis cycle after filling all 18 positions with test tubes. At the end of the cycle and beyond the various options, the REPRINT key, which is pointed out on display, activates even an additional option which will be displayed as io the following example:
6- CORR. % ENTER EXIT If key 6 is pressed, the display shows:
BoosterY
Set
[1] Mod
[2] Exit
ADJUST
%
+1
ESR
Press 1 to display: Press CLEAR and type 1.xx (e.g. 1.10 to increase the ESR results to 10%) or 0.xx (e.g. 0.90 to decrease the ESR results to 10%) and press ENTER. Note: in this context, PAUSE key is to make the point.
The next displayed information point out the obtained BoosterY gain.
BoosterY
Press ENTER
+X.XXXXX
Press key 2 to print out the modified RSR results and compare those with the results been obtained by the referent method. If the results of both systems are balanced, then press ENTER to exit from the REPRINT field. Otherwise if they need to be modified again, press key 6 and repeat the described procedure which can be done for many times until it is achieved a good correlation. Af ter havin g obt ained a go od correlation, the fit ter or tec hnic ian has to di sable El ect ronic Cal ibration
Page 45 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
27
MAINTENANCE TIME
A counter in the analyzer, counts the executed analysis from the last maintenance time. When, along the working days, it reaches the preset maintenance warning again, which value is 30000 normally, the LED set on the left side, above the keypad, blinks The operator, therefore, warned by the analyzer about the necessity to carry out a new maintenance service, has to call the technician trained to carry out this stage.
Page 46 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
28
GENERIC ERROR LIST
Error Cause code
Effect
Solution
Syringe error. The syringe doesn’t go back to home position because sensors or motor malfunctions.
On display appears the message “Error C – ROLLER OFF” Analytical cycle is aborted.
Power off the instrument for 10 seconds and on again or call the technical service.
D-0
EEPROM damaged / absent
On display appears the message “Error D – ROLLER OFF” Analytical cycle is aborted.
Power off the instrument for 10 seconds and on again or call the technical service.
D-1
Commutation between EPROM’s banks not properly working
On display appears the message “Error D-1 – ROLLER OFF” Analytical cycle is aborted.
Power off the instrument for 10 seconds and on again or call the technical service.
E-0
Rotor sensor error. The rotor doesn’t On display appears the message rotate correctly because sensor or motor “Error E – ROLLER OFF” malfunction. Sometimes this error is also Analytical cycle is aborted. due to the front door not closed well or the sensor signal doesn't reflects to metallic reflecting plate.
Power off the instrument for 10 seconds and on again or call the technical service.
F-0
System clock error. The CPU clock doesn’t run correctly.
On display appears the message “Error F – ROLLER OFF” Analytical cycle is aborted.
Power off the instrument for 10 seconds and on again or call the technical service.
On display appears the error “H” while the counter is incremented and the number of NO washed reported in the flag list.
Carry out a washing procedure.
H-0
Washing not executed after the last analysis of the day. The wash missing counter is incremented.
Pump sensor not detected, the rotation of the pump is not detectable for pump motor or pump sensor malfunction.
On display appears the message “Error I – ROLLER OFF”” Analytical cycle is aborted.
Power off the instrument for 10 seconds and on again or call the technical service.
Piston sensor not aligned with the external magnet or damaged.
On display appears the K error message. Press ENTER key to continue.
Call the service as soon as possible
On display appears the message “ Error M “ Press Enter key to continue
Call the Technical Service as soon is possible.
C-0
I-0
K-0
The syringe lifter motor doesn’t rotates. M - 0 The piston is still at low position.
T-1
Improper attempt to transfer credits of ESR from Transfer Smart Card to ROLLER
T-3
Improper attempt to transfer credits of the other parameters from Transfer Smart Card to ROLLER
U-0
Transfer attempt from ROLLER to Smart Card with autonomy less than 1
Press Enter key to continue
Tech. Service message. The transfer process cannot be done.
V-0
Gain value out of working range (min. 0.6000 - max 1,6000
Press Enter key to continue
Call Technical Service
V-1
Model Fact value out of working range min. 0.50 - max 2.00
Press Enter key to continue
Call Technical Service
V-2
Booster Y value out of working range min. 0.50 - max 2.00
Press Enter key to continue
Call Technical Service
V-3
Upgrading the instrument from release 5.xx to release 6.xx
Press Enter key to continue
This error will disappear automatically after pressed Enter
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 remains, call the Technical Service.
Z-0
Press Enter key to continue
Call the Technical Service as soon is possible
Press Enter key to continue
Call the Technical Service as soon is possible
Page 47 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
29
ALERTS LIST and LATEX ERROR LIST Message
Cause
Solution
The blood flow was not regular, for air It is suggested to execute a washing cycle before proceeding with further analysis.
NF is printed instead of ESR bubbles or tubing / needle obstruction. value
Result could be NR (not reliable) if the Try to mix again the blood and repeat the
NR (Not Reliable) is printed reading unit is able to detect the measure instead of ESR value
transition between air (empty capillary) and blood, but is not able to detect the starting of the aggregation. Sometimes this is also due to a poor mixed blood.
This error appears when a sample has Check tubes loaded are in conformity with CM = SM (Sample Missing) is been loaded in the instrument, but it has technical data sheet of the instrument printed instead of ESR value slipped out from the rotor. Instrument is expecting to find a tube (because it has recognized it when loaded) but at the time of perform the analysis the tube is not physically inside the rotor
Increase Avail. Insert CARD
The test availability is under 2000 test, Press Enter to continue. the instrument alerts the customer that is To avoid the message, increase necessary increase the test availability availability inserting a new CARD.
the
The following message printed at power up
is The waste tank counter has reached the Replace or empty the waste tank, then press value of tank alarm (2000 by default) key “1- empty” to reset the counter to zero. The instrument enters automatically in waste tank replacing procedure (9)
The following message printed at power up
is The maintenance counter has reached Call the Technical Service for performing a the value of maintenance alarm (30000 30000 test maintenance. by default). Maintenance is required.
Waste level detected EMPTY the tank
Maintenance Request Checksum error XXX
Exceed expiry date Procedure aborted
Error during the checksum control on 'R' Call the Technical Service for the host message (Results) sent to Host connection. computer The three control tubes are expired, the Check the expiration data of the kit, if expired calibration control could be unreliable, replace it with a new one and repeat the thus the procedure is aborted. control procedure. Verify the date printed by the analyzer during the power-up, correct it if not the current date.
Exceed cont rol availability Procedure aborted
The three control tubes have been used Repeat the control with a new kit or with a kit more than 6 times, the calibration control that was analyzed less than six times. could be unreliable, thus the procedure is aborted.
Different kit number Check tube labels Procedure aborted
The three control tubes don't report the same lot number and the analyser is not able to verify the calibration data coherence.
If between the three test tubes, 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)..
is The values read by the reading cell can not be extrapolated to a reference correlation line. The three values can not be plotted over a line and thus the correlation limit fall outside the minimum reference R2 >= 0,97
Check that the three tubes have the same level of latex; check the needle is not obstructed, if this happens, follow the washing procedures for maintenance.
is The memory of expirations of the kits is momentary not available or exhausted. The date memorized from the analyzer in is not the current one.
Check the date of the analyzer, 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.
The following printed
message
Correlation Not OK
The following printed
message
Unavailable memory E2PROM Procedure aborted
Page 48 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
30
NEEDLE REPLACEMENT
To replace the needle be sure that the instrument is OFF. Follow the instruction and see the photo.
1) Open the front panel.
2) Pull firmly the piston assembly towards you so that the retaining magnets release the assembly.
3) Push down the piston for CBC adapter and with one
4) Replace the needle using the red special
finger of your other hand pull out the clip and remove the piston completely. Be careful to the needle sharp tip that will come out from the piston top! Use glowers to protect your hands!
tool tightening the new-one without force it to avoid to damage the plastic thread part.
Page 49 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
5) Insert the piston looking at its metallic clip that has to fall down in front of you
6) Push down the piston until the metallic clip it will be over the aluminium hook. Release the piston.
7) Push the piston assembly until the magnets retain the piston assembly.
NOTE: We suggest to do a washing procedure cycle after replacing the needle, using two samples filled to ¾ of distillate water and verifying if the water flows from the tube through the capillary during the withdraw without any problems.
Page 50 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
31
SOFTWARE REVISION HISTORY
Date
SW Ver.
Manual Rev.
21.11.05
Ver. 6.00A
Rev. 01
06.02.06
Ver. 6.00B
Rev. 02
26.05.06
Ver. 6.00C
Rev. 03
14.09.06
Ver. 6.01A
Rev. 04
23.04.07
Ver 6.01 A
Rev. 05
20.11.07
Ver 6.01 B
Rev. 06
02.04.08
Ver 6.01 C
Rev. 07
Latex Control management. New statistical data printing relate to the three levels of latex controls Exchanged Booster Y and MFact functions to simplify calibration Differentiate management of Latex Controls and Latex Calibrators New statistical printout to evaluate the analyzer performances Control of expiration date for both Latex Controls and Calibrators Inserted new printings for the latex controls, every time the controls are executed a printout shows also the reference values of the controls and, if the analyzer gain (BoosterY) is different from 1.000, the new reference values calculated with the new gain are printed to give a new comparing table Each variation of BoosterY parameter will modify both the latex controls and the haematic sample results. Inserted the management of the external qualit y control (called VEQ) that disables the printing of the reference values when a kit is recognised as an External Quality Control (VEQ). Fixed software error that sometimes caused error E0 during the home position searching rotation. The functionality of the two amplification software parameters MFact and BoosterY have again separate to allow the independent regulation of the values of the latexes (MFact) and of those of the haematic samples (BoosterY). With the separation of the two amplification parameters, it has also removed the printing of OUT OF STD with the relative new reference values when the BoosterY parameter is different from 1.000. New algorithm for calibration and control with latex, that allow a best correlation and repeatability between instruments. Fixed software error that didn't allow the correct management of offset parameter during the rising of withdrawal piston. Updated test tube characteristics, analytical and operative performances, inserted method limitations and washing procedure if latex controls are used daily. Sw: inserted a routine to better control the stop of blood inside the reading unit. Released sw ver. 6.01C: Operator Manual: updated method limitations, described sanitation procedures. Sw: inserted a routine to better control the stop of blood inside the reading unit. These versions have never been released on the market.
27/08/09
Ver 6.01D Ver 6.01E Ver 6.01F Ver 6.01G
Rev. 08
Correction of “Latex expiration date bug” causing Latex Controls and Calibrators withdrawal even if not expired starting from lots produced in September 2009 and then expiring in 2010 (from Lot no. 10xx and further).
27/10/11
Ver. 6.51C
Rev. 09
• Possibility
to choose the typology of the result printing (detailed or compressed).
•
Multilanguage software (Italian, English, German, French and Spanish). • Possibility to choose which kind of parameter can be printed out on paper assuming they have been enabled by means of a Smart Card. • Possibility to print out the limits next by the lowest and highest ESR result. E.g. (ESR 120). • Reduced the analysis from 24 seconds to 20.
Page 51 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
32
SANITATION PROCEDURE
The following procedure must be executed before: 1) 2)
Collection/shipment of the instrument from laboratory after a demo or for replacement/reparations. Technical service repair or check inside the instrument.
Protection tools and suggested materials to be used: 1) 2) 3) 4)
Glasses. Latex gloves. Absorbing paper towels. Plastic bag for waste disposal .
For the description of sanitation procedures of a working instrument: refer to the Sanitation Form (appendix E) The Sanitation Form MUST be filled up and accompany the instrument. . In case the sanitation cannot be executed due to a failure of the washing system, contact your Local Technical Service. Note: we suggest to make a copy of the appendix B at each sanitation and to fill it according to the sanitation procedure.
33
BEFORE SWITCHING OFF THE ANALYSER
Before switching OFF the analyzer it is strongly suggested to clean the capillary with three test tubes filled with distilled water so that the needle remains inside the third test tube to maintain wet particles of blood still present in it. At the end of this process, the instrument prints out “WASHING EXECUTED” and “ PHOTOMETER OK” . Check the message and then turn the analyzer off pressing the rear side switch.
Page 52 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
OPERATOR MANUAL ROLLER 20LC(SI R20-LC) Ed. 1 Rev.13 -2014, Apr il, 05
34
REFERENCES
Manufacturer: SIRE Analytical Systems s.r.l. Via Merano 30 33045 Nimis (UD) Italy Tel +39 0432 547454 - Fax +39 0432 547378
Company certif ied by ISO 9001:2008 EN ISO 13485:2012/AC:2012 ISO 13485:2003 (CMDCAS)
TÜV Italia S.r.l. TÜV SÜD Product Service GmbH TÜV SÜD America Inc.
501006107 Q1N130371065001 QS1130471065002
The instrument is CE certified According to directive 98/79/EC relative to In Vitro Diagnostic Medical Devices
Worldwide distributor:: ALIFAX S.p.A. via F. Petrarca 2 Isola dell'Abbà 35020 Polverara (PD) Tel. +39-049-0992000 e-mail
[email protected] web www.alifax.com
Page 53 ESR_UM_SIR20LC_ ROLLER20LC SW 6.51C_1-13_EN.DOC
USER MANUAL
