Greiner Bio-One Sed Rate Timer 10/II User Manual
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Greiner Bio-One Sed Rate Timer 10/II User Manual

Esr analyzer, including software (g2m110bo, vers. 1.1),
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Sed Rate Timer 10/lI (SRT10/II)
including Software (G2M110BO, Vers. 1.1)
ESR Analyzer
(optional thermal printer available)
USER'S MANUAL
MAN-003 – Revision 09
Revision date: January, 2019
SRT 10/II
USER MANUAL
page 1 of 37

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  • Page 1 Sed Rate Timer 10/lI (SRT10/II) including Software (G2M110BO, Vers. 1.1) ESR Analyzer (optional thermal printer available) USER'S MANUAL MAN-003 – Revision 09 Revision date: January, 2019 SRT 10/II USER MANUAL page 1 of 37...
  • Page 2 This user manual follows the directions as prescribed by the CEN/TC 140 recommendations for in -vitro diagnostic instruments: INSTRUMENT NAME: Sed Rate Timer 10/II (SRT 10/II) including Software (G2M110BO, Vers. 1.1) Short cut name: SRT 10/II Automatic Sed-Rate analyzer, 10 measuring channels Greiner Bio-One GmbH Bad Haller Straße 32...

  • Page 3: Table Of Contents

    CONTENTS 1. INTRODUCTION ............................5 1.1 I ............................5 NTENDED USE 2. POTENTIAL DANGERS AND SAFETY PRECAUTIONS ................5 2.1 U ..........................5 RECAUTIONS 2.2 E ..........................5 LECTRICAL EQUIPMENT 2.3 M ........................... 5 ECHANICAL EQUIPMENT 2.4 B .......................... 5 IOHAZARDOUS MATERIAL 2.5 N ........................
  • Page 4 B. PRINTER CONNECTOR ........................32 C. D ........................ 33 ECONTAMINATION ROCEDURE SRT 10/II USER MANUAL page 4 of 37...

  • Page 5: Introduction

    1. INTRODUCTION 1.1 Intended use The SRT 10/II analyzer is an automatic instrument controlled by a microprocessor and exclusively employed for analysis of the in vitro diagnostics determination (IVD) of erythrocyte sedimentation rate (ESR). It constantly and simultaneously scans 10 test tubes, which are custom-made for ESR analysis.

  • Page 6: Notes On Safety Measure

    2.4.1 Human samples Always wear gloves and eye protective glasses when handling human samples. Treat all samples as potentially bio-hazardous and infectious. If any sample is spilt on the instrument, utilize the correct personal protective equipment (PPE-gloves, lab coat, etc.), wipe it up immediately and clean the contaminated surface with a disinfectant (e.g.sodium hypochlorite 0.5%) solution.

  • Page 7: Additional Precautions

    2.8 Additional Precautions The following symbols are placed on the instrument and/or on the outer box to assure correct usage: Caution In vitro diagnostic Consult instructions medical device for use Biological risks See chapter 2.6 Electrostatic discharge ‘Disposal and recycling’ sensitive device (ESDS) DC (direct current) Manufacturer...

  • Page 8: Installation

    3. INSTALLATION 3.1 Delivery contents Check contents of carton using this list • 1x SRT 10/II • 1x 12-volt power supply • 1x Power cable with Schuko plug • 1x Control unit (contains three ESR Tubes with different long plastic sticks) •...

  • Page 9: Configuration

    Connect the SRT10/II to the electricity supply by plugging the 12V power supply into the intended power inlet on the SRT10/II. Only use the power supply provided. 3.3 Configuration Before switching on the analyzer, please set-up the dip-switch placed in the rear panel following the table below: Switch Function...
  • Page 10 15 minutes analysis time N° Function Position Switch Enable 15' analysis time. Enable 60' analysis time (works only if switch 1 = off) Enable additional result formats (works only if switch 1 = off) Enable temperature compensation Enable the printer Enable sedimentation curve graph Enable the internal fan Enable power supply on printer connector (DPT100 printer)
  • Page 11 Each time SRT 10/II is switched on, it carries out an electronic initialization and an instrument check test. On the display appears this message: greiner Bio-One SRT10/II V.1.1 then configuration data appears (dependant on the switch settings defined in chapter 3.3...
  • Page 12 If the printer is connected, on the display appears this message: Print curve ON... Printer OK... If the printer is not enabled the following message appears: Printer OFF... if the temperature compensation is active, the following message appears on the display: 18°C temp.

  • Page 13: System Description

    4. SYSTEM DESCRIPTION 4.1 Analyzer unit The SRT 10/II ESR analyzer is an automatic instrument controlled by a microprocessor and exclusively employed for analysis of the erythrocyte sedimentation rate. It’s total absence of commands, its precision and its ability to obtain the result already corrected to a temperature of 18°C (according to Manley) in either 15, 30 or 60 minutes make it the most innovative and versatile system for this kind of analysis.

  • Page 14: Reading Plate

    4.3 Display A 40-character two-line LCD display with backlight, allows a continuous monitoring of the analysis and a visualization of the results. On the display can be also shown a sample or a system error message. Please note that the display can indicate more than one results for each sample, according to dip-switch configuration set up by operator.
  • Page 15 4.8 Performance criteria and limitations 1) PERFORMANCE CRITERIA A. Mechanical / Optical precision of detection +/- 0.2 mm B. Coefficient of determination (reading time 15 min.) = 0.958 C. Coefficient of determination (reading time 30 min.) = 0.970 D. Automatic temperature conversion Accepted range: 15°C - 32°C to 18°C.

  • Page 16: Operating Procedure

    5. OPERATING PROCEDURE 5.1 Reading principle Ten infrared barriers cover vertically the ten test tubes with a cycle of about 60”. The whole test tubes, every 0.2 mm gap are analyzed. As soon as the reading plate, including 10 pairs of I.R.

  • Page 17: Functional Sequence Of Analysis

    5.2 Functional Sequence of Analysis STAND BY TUBE DETECTION INDEPENDENT PRE-INDICATION READING OF RESULTS PROCESS READING TIME CALCULATION TEMPERATURE DETECTION TEMPERATURE CORRECTION RESULTS GRAPH ENABLE OPTIONAL PRINTING GRAPH SRT 10/II USER MANUAL page 17 of 37...

  • Page 18: Sample Collecting

    5.3 Sample collecting ® Samples must be collected following the vacuum technique with VACUETTE ESR Vacuum Test Tubes, 1.6 ml draw (Item Nr. 729093) or 1.5 ml draw (Item Nr.729073). During sample collecting to be sure to have the right volume of blood, it is necessary to wait until the test vacuum tube finished the blood drawing.

  • Page 19: Sample Mixing

    External agents a) Dilution ratio b) Bubbles c) Strongly hemolytic samples d) Sudden agitation e) Temperature f) Time after sample-taking g) Direct sunlight h) Foam i) Lipemic samples 5.5 Sample mixing When it is not possible to analyze the sample immediately after sample collecting, it must be ®...
  • Page 20 5.8 Brief working instructions 1. Set up instrument: Connect power supply and printer, 2. Switch on printer and analyzer unit: On the display appears some information (i.e. software release) and this symbol: “ . ” appears for each free channel. It indicates free positions on which the operator can put samples.

  • Page 21: Temperature Compensation

    6. TEMPERATURE COMPENSATION 6.1 Results correction to 18°C The results achieved are correlated to the method of reference, considering the room - temperature. SRT 10/II, measures constantly the inner temperature; further reconverts the values in according to the Manley table (1) shown below, at the temperature of 18 degrees. Therefore, this instrument guarantees a better reproducibility instead of instruments which perform results without temperature compensation.

  • Page 22: Practical Use

    7. PRACTICAL USE 7.1 How to Use the Instrument SRT 10/II is very simple to use and the procedure can be learnt quickly. Being already pre- set, no configuration is necessary after switching on, so the operator does not input data. For this reason there is no user interface keyboard.

  • Page 23: Error Information And Warnings

    7.2 Limit of the Instrument SRT 10/II reading limits is max. 140 mm. at 18°C. When a sample has a value > 140 mm, this message is displayed or printed: “> 140” 8. ERROR INFORMATION AND WARNINGS 8.1 Warnings information check the printer! This message appears when printer is enabled in the SRT 10/II, but not switched on.

  • Page 24: Maintenance

    4. Wipe areas again with cloth or paper towel with reagent grade water to remove the Solution A. 5. Dry areas thoroughly. 9.2 Spare parts SED RATE TIMER 10/II - SPARE PARTS LIST Code Description ESR-Spare part SEM30-001 Fan 836250 for SRT 10/II, MultiMixer 12 Vdc;...
  • Page 25 9.2 Periodic test In order to assure the correct performance of instrument and obtaining precise results, it needs to perform a periodic test, once a month, which controls the accurate calibration of the device. The test has to be done using the Greiner Control Unit (Control Tool). This tool can be used by service people to check the mechanical calibration and functionality of the instrument.

  • Page 26: Troubleshooting Guide

    10. TROUBLESHOOTING GUIDE Before calling a service technician, please check the handling of sample collection, mixing procedures and operating instructions. ALARM OR TROUBLE CAUSE REMEDY a) sample level high or low a)repeat sample collection b) the label was not placed in its b)replace label and repeat analysis proper position.

  • Page 27: Technical Specifications

    11. TECHNICAL SPECIFICATIONS Area of application Blood sedimentation rate analysis Instrument size: Width 290 mm Depth 190 mm Height 170 mm Weight: about 2 kg Instrument input and output: 12 VDC 1.5 A (external power supply unit) External power supply unit input: 100 - 240 VAC +/-10%, 1.8A, 50/60 Hz Operating Conditions: temperature 15°...
  • Page 28 EMC Standards: EN 61326-6:2006 Safety Standards: IEC/EN 61010-1:2010 IEC/EN 61010-2-101:2015 Machine Directives: 98/79/EC Transport and Storage: Do not refrigerate during transport Storage temperature: 4 – 30°C Storage relative humidity: 20%-85% Appropriate decontamination shall be performed prior to transportation, removal from use and/or disposal. See Decontamination instruction ESR Instrument for details.

  • Page 29: Packaging Information

    12. PACKAGING INFORMATION BOX SIZE: 30 x 60 x 36 cm WEIGHT: 3.5 kg Closed box Open box Unpacked ESR instrument ACCESSORIES included in the packaging Power supply Power cable Control Unit - self-test tool Dust cover User Manual on USB Stick Certificate of Quality SRT 10/II USER MANUAL...
  • Page 30 Optional Accessories not included in the packaging 836582 836595 Thermal printer for SRT 10/II, ACCUSED PLUS QC Control Blood for SRS SRT 10/II USER MANUAL page 30 of 37...

  • Page 31: Appendix

    APPENDIX A. THEORETICAL INFORMATION A.1 Westergren Method This is the standard method in accordance with the National Committee for Clinical Laboratory Standards. It consists in a support that keeps the Westergren tubes, containing non-clottable blood perfectly vertical and hermetically sealed. Westergren tubes have a diameter of not less than 2.55 mm and are graduated up to 200 mm.
  • Page 32 B. Moderate increase of ESR C. Normality of ESR (most cases) 1. Acute and chronic contagious diseases 1. First stage acute appendicitis 2. Acute localized infections (in the first 24 hours) 3. Reactivation of a chronic infection 2. Precocious integral ectopic pregnancy 4.
  • Page 33 The contents of this instruction can also be changed without prior warning. Greiner Bio-One cannot be held responsible for any damage resulting from changes made to the instrument after it was supplied. Greiner Bio-One cannot be held responsible for any damage resulting from not complying to the specifications supplied with the instrument.
  • Page 34 We always try to be as complete as possible but we can imagine that questions remain after reading this document. Please feel free to contact us in case of any questions. Product Management Preanalytics Greiner Bio-One Austria SRT 10/II USER MANUAL...
  • Page 35 Safety Requirements and Restrictions. Personal protections. When performing this procedure, wear, at a minimum, safety glasses, gloves and disposable lab coat (according Good Laboratory Practice). Spills of fluid waste prior to decontamination. Wipe up spills with paper towels. Clean area with decontamination solution. Dispose of paper towels in a container designated for biohazard waste or autoclave before putting in general trash.
  • Page 36 Decontamination Procedure Although the Instrument only uses closed ESR tubes and therefore the contamination of the Instruments is reducing to an absolute minimum one has to treat any foreign material on any surface of the Instrument as a biohazard for safety. Treated surface should remain in contact with decontamination solution for at least 10 minutes.
  • Page 37 Executor Engineer: Distributor stamp: Date (dd/mm/yyyy) Name: Signature: Greiner Bio-One GmbH – Bad Haller Str. 35 - 4550 - Kremsmuenster - Austria Tel.: +43 7583 6791-0 - Fax: +43 7583 6318 - E-mail: faq.at@gbo.com - Website: www.gbo.com SRT 10/II USER MANUAL...

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