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

SRT 10/II
USER MANUAL
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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
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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
A-4550 Kremsmünster
AUSTRIA
Tel.: [phone]
Fax.: [phone]
Mail: [email protected]
PLEASE READ THIS ENTIRE PRODUCT MANUAL
BEFORE USING THE INSTRUMENT FOR THE FIRST TIME.

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USER MANUAL
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CONTENTS
1. INTRODUCTION........................................................................................................................................... 5
1.1 INTENDED USE........................................................................................................................................... 5
2. POTENTIAL DANGERS AND SAFETY PRECAUTIONS............................................................................ 5
2.1 USER PRECAUTIONS.................................................................................................................................. 5
2.2 ELECTRICAL EQUIPMENT ............................................................................................................................ 5
2.3 MECHANICAL EQUIPMENT ........................................................................................................................... 5
2.4 BIOHAZARDOUS MATERIAL.......................................................................................................................... 5
2.5 NOTES ON SAFETY MEASURE...................................................................................................................... 6
2.6 DISPOSAL AND RECYCLING......................................................................................................................... 6
2.7 BIO-HAZARDOUS PARTS DISPOSAL............................................................................................................. 6
2.8 ADDITIONAL PRECAUTIONS......................................................................................................................... 7
3. INSTALLATION ........................................................................................................................................... 8
3.2 POSITIONING OF THE ANALYZER.................................................................................................................. 8
3.3 CONFIGURATION........................................................................................................................................ 9
4. SYSTEM DESCRIPTION ............................................................................................................................ 13
4.1 ANALYZER UNIT ....................................................................................................................................... 13
4.2 PRE-INDICATION OF THE RESULTS............................................................................................................. 13
4.4 READING PLATE....................................................................................................................................... 14
4.5 POWER SUPPLY....................................................................................................................................... 14
4.6 PRINTER.................................................................................................................................................. 14
4.7 TEST TUBES............................................................................................................................................ 14
5. OPERATING PROCEDURE ....................................................................................................................... 16
5.1 READING PRINCIPLE................................................................................................................................. 16
5.2 FUNCTIONAL SEQUENCE OF ANALYSIS...................................................................................................... 17
5.3 SAMPLE COLLECTING ............................................................................................................................... 18
5.4 LABELING ................................................................................................................................................ 18
5.5 SAMPLE MIXING ....................................................................................................................................... 19
5.6 SAMPLE POSITIONING............................................................................................................................... 19
5.7 SAMPLE REMOVAL.................................................................................................................................... 19
6. TEMPERATURE COMPENSATION........................................................................................................... 21
6.1 RESULTS CORRECTION TO 18°C............................................................................................................... 21
6.2 RESULT................................................................................................................................................... 21
7. PRACTICAL USE........................................................................................................................................ 22
7.1 HOW TO USE THE INSTRUMENT ................................................................................................................ 22
8. ERROR INFORMATION AND WARNINGS ............................................................................................... 23
8.1WARNINGS INFORMATION......................................................................................................................... 23
8.2 SYSTEM ERROR WARNINGS ..................................................................................................................... 23
9. MAINTENANCE .......................................................................................................................................... 24
9.1 CLEANING AND DECONTAMINATION INSTRUCTIONS..................................................................................... 24
9.2 SPARE PARTS.......................................................................................................................................... 24
10. TROUBLESHOOTING GUIDE.................................................................................................................. 26
11. TECHNICAL SPECIFICATIONS............................................................................................................... 27
12. PACKAGING INFORMATION .................................................................................................................. 29
APPENDIX .................................................................................................................................................. 30
A. THEORETICAL INFORMATION............................................................................................................. 31

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USER MANUAL
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B. PRINTER CONNECTOR ........................................................................................................................ 32
C. DECONTAMINATION PROCEDURE................................................................................................................ 33

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USER MANUAL
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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. The SRT 10/II follows the sedimentation
of each sample independently, memorizing levels for the whole period of analysis.
Every attempt to use the SRT 10/II ESR analyzer with a purpose different from the
intended use, must be considered improper.
2. POTENTIAL DANGERS AND SAFETY PRECAUTIONS
2.1 User Precautions
Before beginning the use of the analyzer, the operator must know the rules for handling
potentially infectious materials and for handling Electro-mechanical systems.
2.1.1 User Identification
This ESR analyzer is intended for professional use only. The operator must be trained for
working in laboratory using hazardous materials and professional equipment. The use of
this ESR analyzer by a not trained operator is considered an improper use.
2.2 Electrical equipment
As all electrical equipment, the power supply is a potential source of danger. Please avoid
handling electrical parts before disconnecting them from the power supply. Never carry out
maintenance on the instrument when it is under electrical tension. Until the instrument is
packaged, as supplied, the operator is protected against electric shock. Pay attention to
the following electrical parts: the power supply and the printer. The SRT 10/II analyzer, is
powered by low voltage, and it doesn’t present the same dangers of the equipment’s
powered by an electrical line. Even though it has a voltage elevator circuit inside, and it
could provoke strong electrical shocks, it is not dangerous for the service assistance
personnel. We suggest to disconnect the power supply every time a technical operator make
instrument maintenance.
2.3 Mechanical equipment
For the mechanical part of the analyzer, we suggest to not open the machine before having
disconnected it from the power supply. If the power is on, it is not dangerous for the operator,
but instrument would damage if brought into contact with the parts in movement.
2.4 Biohazardous material
As with all in vitro diagnostic equipment, patient samples and quality control (QC) products
that are assayed on this system, should be treated as potentially bio-hazardous. All
materials should be handled according to your facility's biohazard procedure. Always wear
the personal protective equipment recommended by your facility when using the analyzer.

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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.
2.4.2 Waste solution and solid waste
Avoid direct contact with waste solution and/or solid waste. Both should be handled as
potentially bio-hazardous. Dispose of waste solution and/or solid waste according to local
governmental regulations.
2.5 Notes on safety measure
Please pay attention to the sample collection. The vacuum test tubes used for this
instrument, have been studied to draw the right level of blood. To fill the test tube with a
higher volume of blood, could cause a serious infection risk for tube leakage. Furthermore
the leakage could damage the inner optical part of the instrument and annul the guarantee.
2.6 Disposal and Recycling
Herewith we declare that this instrument is subject to the European Directive 2011/65/EU
(RAEE Directive) and 2011/65/EU. Therefore the instrument must be disposed separately,
not as urban waste and delivered to the specific collection centre in accordance with the
Directive 2011/65/EU.
The user may request that the supplier collect the instrument for correct disposal, if a new
instrument is ordered.
2.7 Bio-Hazardous Parts Disposal
All parts which have a direct contact with samples must be disposed as POTENTIALLY
INFECTIOUS. Follow local regulations.
The instrument is not intended to be integrated into a system

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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
medical device
Consult instructions
for use
Biological risks
See chapter 2.6
‘Disposal and recycling’
Electrostatic discharge
sensitive device (ESDS)
DC (direct current)
Manufacturer
Date of manufacture
Serial number
Conformité Européenne
(European Conformity)
Catalogue number

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USER MANUAL
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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)
•1x User Manual on an USB Stick
•1x Dust cover
•1x Certificate of Quality
Optional –not included in the packaging
836582 Thermal printer for SRT 10/II, SRS 20/II and SRS 100/II
836595 ACCUSED PLUS QC Control Blood for SRS
3.2 Positioning of the analyzer
The SRT 10/II must not be placed near centrifuges, oscillating agitators or other vibrating
instruments that might cause movement of the bench. Please keep in mind that ESR is very
sensitive to vibrations that could cause a false increase of results. The bench must be flat
and level. Direct light on the instrument and sudden changes of temperature should be
avoided. Keep a free area of at least 15 cm around the instrument to allow instrument cooling
by the internal back panel fan. Connect the instrument power supply only of the type
described in this User’s Manual. Use the mains plug to disconnect the apparatus from the
mains supply. The mains plug must be accessible at all times.
Do not use this device in close proximity to sources of strong electromagnetic
radiation (e.g. unshielded intentional RF sources), as these may interfere with
proper operation.
Therefore the electromagnetic environment should be evaluated prior to operation
of the device.
The instrument is not intended to be integrated into a system.
Do not replace the detachable power cord by an inadequately rated power cord.

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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
1
Enable 15' analysis time.
2
Enable 60' analysis time (works only if switch 1 = off)
3
Enable additional result formats (works only if switch 1 = off)
4
Enable temperature compensation
5
Enable the printer
6
Enable sedimentation curve graph
7
Enable the internal fan
8
Enable power supply on printer connector ( DPT100 printer )
WARNING!: Do not switch on power when using a different type of
printer, as serious damage could be caused.
To enable each function be sure that the corresponding switch is in the ON position. For
the analysis time and the results formats the following configurations are possible:
SW1
SW2
SW3
Analysis
time
Results format(s)
On
x
x
15'
mm/1hr
Off
On
On
60'
mm/2hr & mm/1hr & mm/30'
Off
On
Off
60'
mm/2hr
Off
Off
On
30'
mm/1hr & mm/30'
Off
Off
Off
30'
mm/1hr
(where 'x' = don't care, has no effect)
Example:
to configure instrument for 15 and 30 minutes analysis time, results corresponding to 1
hour Westergren, with temperature compensation, connected to the thermal printer (Item
number 836582), switches are placed: (Default Setting)

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USER MANUAL
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15 minutes analysis time
N°
Switch
Function
Position
1
Enable 15' analysis time.
ON
2
Enable 60' analysis time (works only if switch 1 = off)
x
3
Enable additional result formats (works only if switch 1 = off)
x
4
Enable temperature compensation
ON
5
Enable the printer
ON
6
Enable sedimentation curve graph
OFF
7
Enable the internal fan
ON
8
Enable power supply on printer connector (DPT100 printer)
ON
(where 'x' = don't care, has no effect)
30 minutes analysis time
N° Switch
Function
Position
1
Enable 15' analysis time.
OFF
2
Enable 60' analysis time (works only if switch 1 = off)
OFF
3
Enable additional result formats (works only if switch 1 = off)
OFF
4
Enable temperature compensation
ON
5
Enable the printer
ON
6
Enable sedimentation curve graph
OFF
7
Enable the internal fan
ON
8
Enable power supply on printer connector (DPT100 printer)
ON