RR Mechatronics STARRSED TL User manual

STARRSED TL USER
MANUAL
Version 1.00 MRN-171-EN
Master Registration Number: MRN-171-EN

Manufacturer: RR Mechatronics Manufacturing B.V.
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
Internet: http://www.rrmechatronics.com
Postal address:
P.O. Box 225
1620 AE Hoorn
The Netherlands
Office address:
De Corantijn 13
1689 AN Zwaag
The Netherlands
© Copyright RR Mechatronics Manufacturing B.V.
All rights reserved.
Subject to changes without prior notice.
Issued by the Support Department of RR Mechatronics

Introduction
Starrsed TL User Manual Page 3
Version 1.00 MRN-171-EN
Document history overview
MRN-171-EN
Published date Wednesday, 17 October 2018
Issue No Date Revised Section(s) Changes Authorised
1.00 Oct. 2018 All  Manual updated up to latest
configuration and software
version 6.11
H. Schavemaker
DRAFT may
2016
 First issue H. Schavemaker

Contents
Starrsed TL User Manual Page 5
Version 1.00 MRN-171-EN
CONTENTS
1.INTRODUCTION .......................................................................................................... 11
1.1.Intended use of device ............................................................................................ 11
1.2.Indication for use of device ...................................................................................... 11
1.3.Instrument overview ................................................................................................ 12
1.4.Explanation of symbols ............................................................................................ 13
1.5.EQAS ....................................................................................................................... 14
1.6.Explanation of available documentation .................................................................. 14
1.7.Starrsed line of ESR instruments ............................................................................ 14
1.8.Dilution principle ...................................................................................................... 15
1.9.Sedimentation measurement principle .................................................................... 15
2.INSTRUMENT DESCRIPTION ..................................................................................... 16
2.1.Technical specifications ........................................................................................... 18
2.2.Accessory kit ........................................................................................................... 19
2.3.Used reagents ......................................................................................................... 20
2.3.1.Starrsed Rinse solution ................................................................................. 20
2.3.2.Starrsed Diluent ............................................................................................ 20
2.3.3.Deionized water ............................................................................................ 20
2.3.4.Starrsed Disinfectant .................................................................................... 20
2.3.5.Starrsed Cleaning Agent ............................................................................... 20
3.GENERAL SAFETY INSTRUCTIONS ......................................................................... 21
3.1.Safety warning ......................................................................................................... 21
3.2.Moving parts warning .............................................................................................. 22
4.INSTALLATION ........................................................................................................... 23
5.STANDARD OPERATING PROCEDURES (S.O.P.) ................................................... 24
5.1.Basics of bio safety .................................................................................................. 24
5.2.S.O.P. for working with bio hazardous materials ..................................................... 25
5.2.1.Facts and definitions: .................................................................................... 25
5.2.2.Medical requirements: .................................................................................. 25
5.2.3.General laboratory practices: ........................................................................ 25
5.2.4.Specific laboratory practices and requirements: ........................................... 26
5.3.E.C. Declaration Starrsed TL ................................................................................... 27
5.4.Labels and stickers on containers ........................................................................... 28
6.STARRSED TL PROGRAM ......................................................................................... 29
6.1.Software version ...................................................................................................... 29
6.2.Sample screen ......................................................................................................... 30
6.2.1.Sample screen sections explanation ............................................................ 32
6.2.2.Sample screen with keyboard ....................................................................... 34
6.2.3.Pipette information ........................................................................................ 34

Contents
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Version 1.00 MRN-171-EN
6.3.History screen .......................................................................................................... 35
6.3.1.Display pipette data ...................................................................................... 36
6.3.2.Display Sample history ................................................................................. 37
6.3.2.1.Display patient results .............................................................................. 38
6.3.2.2.History sample analyse option .................................................................. 39
6.3.2.3.Set start/end date ..................................................................................... 40
6.3.3.ESR Statistics screens ................................................................................. 41
6.3.4.QC Results screens ...................................................................................... 42
6.3.4.1.QC Normal results (table) ......................................................................... 42
6.3.4.2.QC abnormal results (table) ..................................................................... 43
6.3.4.3.QC abnormal results (graph) .................................................................... 45
6.3.4.4.QC abnormal results screen extended ..................................................... 46
6.3.4.5.Display sample history (QC) ..................................................................... 46
6.3.4.6.Linked QC ID's ......................................................................................... 47
6.3.4.7.QC Result analysis ................................................................................... 48
6.3.5.History analyse ............................................................................................. 48
6.3.6.History analyse results dilution ..................................................................... 49
6.3.7.History aspect ............................................................................................... 49
6.3.8.History analyse error ..................................................................................... 50
6.3.9.History analyse warning ................................................................................ 50
6.4.Reagents screen ..................................................................................................... 51
6.4.1.Display reagent history ................................................................................. 52
6.4.2.New reagent input ......................................................................................... 52
6.4.2.1.New reagent input (cont) .......................................................................... 53
6.5.Maintenance screen ................................................................................................ 54
6.5.1.Prime / Clean ................................................................................................ 55
6.5.1.1.Fill and Clean screen ................................................................................ 57
6.5.1.2.End-of-day-wash procedure ..................................................................... 57
6.5.2.Check sensors .............................................................................................. 58
6.5.2.1.Check sensors in service mode ................................................................ 60
6.5.3.Display error history ...................................................................................... 61
6.5.4.Display maintenance history ......................................................................... 62
6.5.5.Maintenance info .......................................................................................... 63
6.5.6.Close ............................................................................................................. 63
6.5.7.End-of-day-wash options .............................................................................. 64
6.5.8.End-of-day-wash schedule settings .............................................................. 65
6.6.General settings ...................................................................................................... 65
6.6.1.ON and OFF selection .................................................................................. 67
6.6.2.Display settings ............................................................................................. 68
6.6.3.Carousel control ............................................................................................ 69
6.6.3.1.Pipette flow tests ...................................................................................... 71
6.6.3.2.Set new rinse position .............................................................................. 73
6.6.4.Diluter settings .............................................................................................. 74
6.6.4.1.Dilution adjustment 60 till 140% ............................................................... 74
6.6.4.2.Dilution error detection 0 till 25% .............................................................. 74
6.6.4.3.Auto dilution adjust ................................................................................... 75
6.6.4.4.Diluent flow check..................................................................................... 75
6.6.5.Limit error settings ........................................................................................ 76
6.6.6.QC Settings .................................................................................................. 77
6.7.Service screen ......................................................................................................... 79

Contents
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6.7.1.TLAX settings ............................................................................................... 80
6.7.1.1.Service...................................................................................................... 80
6.7.1.2.Service Monitor......................................................................................... 86
6.7.2.LIMS settings ................................................................................................ 87
6.7.2.1.Set LIMS communication settings ............................................................ 87
6.7.2.2.Set protocol settings ................................................................................. 88
6.7.3.ESR unit settings .......................................................................................... 89
6.7.4.Manual control .............................................................................................. 90
6.7.4.1.Needle Control.......................................................................................... 91
6.7.4.2.Valve control ............................................................................................. 92
6.7.5.Display error history (Service) ...................................................................... 93
6.7.6.Display maintenance history (Service) ......................................................... 93
7.GETTING STARTED .................................................................................................... 94
7.1.Limit filter settings .................................................................................................... 94
7.2.Liquid levels ............................................................................................................. 94
7.3.Reagents preparation .............................................................................................. 94
7.3.1.Starrsed Cleaning Agent ............................................................................... 96
8.REPORTING ................................................................................................................ 97
8.1.Protocols .................................................................................................................. 97
8.2.Result Printout ......................................................................................................... 97
8.2.1.Report 60-Minute mode ................................................................................ 97
8.2.2.Report 30 Minute mode ................................................................................ 99
8.2.3.ESR Error ..................................................................................................... 99
8.2.3.1.ESR Error and Warning code messages .................................................. 99
8.2.4.Limit error settings ...................................................................................... 101
8.2.5.Reporting range .......................................................................................... 101
8.2.5.1.Reporting range minumum value ........................................................... 101
8.2.6.Aspect Hazy ................................................................................................ 102
8.2.6.1.Analyser "HAZY" code messages .......................................................... 103
9.OPERATION .............................................................................................................. 104
9.1.Quick start-up ........................................................................................................ 104
9.1.1.Power up sequence .................................................................................... 104
9.1.2.Check list .................................................................................................... 104
9.1.3.Liquid levels ................................................................................................ 104
9.2.Checks during operation ........................................................................................ 105
9.3.Manual sampling ................................................................................................... 105
9.4.Priming the fluid system ........................................................................................ 106
9.5.End of day ............................................................................................................. 107
9.5.1.End-of-day-wash procedure ....................................................................... 107
9.5.2.Turn off sequence ....................................................................................... 107
10.QUALITY CONTROL ................................................................................................. 108
10.1.Control pipettes .................................................................................................. 108
10.2.Monitoring measurement quality with Starrsed Control ..................................... 108
10.2.1.Limitations ................................................................................................... 108
10.2.2.Expected value range ................................................................................. 108

Contents
Page 8 Starrsed TL User Manual
Version 1.00 MRN-171-EN
10.2.3.Temperature correction .............................................................................. 109
10.2.4.Usage options ............................................................................................. 109
10.2.5.Quality control procedure ............................................................................ 110
10.2.6.QC Results ................................................................................................. 110
10.2.6.1.QC Error messages .............................................................................. 111
10.2.6.2.QC Result analysis ............................................................................... 112
11.ESR ANALYSER UNIT SYSTEM MESSAGES ......................................................... 113
11.1.System messages .............................................................................................. 113
11.2.Test messages ................................................................................................... 113
11.3.System time-out <xxxx> ..................................................................................... 114
11.4.Error Messages .................................................................................................. 114
12.WASTE HANDLING ................................................................................................... 115
12.1.Waste line connection to central waste system ................................................. 115
13.GENERAL MAINTENANCE ....................................................................................... 116
13.1.Daily ................................................................................................................... 116
13.2.Weekly ............................................................................................................... 116
13.2.1.Check the sensors in service mode ............................................................ 117
13.2.2.Cleaning liquid separator ............................................................................ 117
13.3.Level 4 maintenance .......................................................................................... 118
13.3.1.Pump tubes replacement ............................................................................ 118
13.3.2.Replace bacterial filter ................................................................................ 121
13.3.3.Fill-nozzle O-ring replacement .................................................................... 121
13.3.4.Fill and clean procedure ............................................................................. 121
13.3.5.Replace needle O-ring ................................................................................ 123
13.4.Level 3 maintenance .......................................................................................... 125
13.5.Level 2 maintenance .......................................................................................... 125
13.6.Level 2 maintenance .......................................................................................... 126
13.7.Check or replace needle .................................................................................... 126
13.8.Reagents replacement ....................................................................................... 129
14.DATA SAFETY MANAGEMENT ............................................................................... 132
14.1.Power failure ...................................................................................................... 132
14.2.PC output ........................................................................................................... 132
14.3.Specifications for the RS232 port ...................................................................... 132
14.4.Folder Structure on PC ...................................................................................... 132
15.TROUBLE SHOOTING .............................................................................................. 133
15.1.Peristaltic pumps ................................................................................................ 133
15.1.1.Rinse solution not primed through the system ............................................ 133
15.1.2.Rinse solution spilling over the instrument ................................................. 134
15.1.3.Rinse pump failure ...................................................................................... 134
15.1.4.Sample probe is not washed after aspiration .............................................. 134
15.1.5.Pipettes not dry after washing and drying cycle ......................................... 135
15.2.Liquid level sensor not sensing .......................................................................... 135

Contents
Starrsed TL User Manual Page 9
Version 1.00 MRN-171-EN
15.3.Flushing liquids .................................................................................................. 135
15.3.1.De-ionized water ......................................................................................... 135
15.3.2.Disinfectant ................................................................................................. 136
15.4.Diluter system not sufficiently primed ................................................................ 136
15.5.Diluter errors ...................................................................................................... 137
15.6.Air bubbles entering the Diluent system ............................................................ 138
15.7.Vacuum .............................................................................................................. 139
15.7.1.Vacuum stabilisation problems ................................................................... 139
15.7.2.Vacuum error .............................................................................................. 140
15.8.Needle system ................................................................................................... 140
15.8.1.Needle not in top position ........................................................................... 141
15.8.2.Sample probe fails to go down ................................................................... 141
15.9.Leaking pipettes ................................................................................................. 141
15.10.Air bubbles ..................................................................................................... 142
15.10.1.Foam in column ....................................................................................... 142
15.10.2.Pipette looks like zebra crossing ............................................................. 143
15.10.3.One air bubble about 5 mm under meniscus .......................................... 143
15.10.4.One air bubble rising in pipette ............................................................... 144
15.10.5.Small air bubbles rising in pipette ........................................................... 144
15.10.6.Random air bubbles in pipette ................................................................ 144
15.11.Rinse nozzle (wash station) alignment ........................................................... 145
15.12.Hazy reports ................................................................................................... 145
15.12.1.Hazy reports after cleaning ..................................................................... 146
15.13.Contaminated instrument ............................................................................... 146
15.14.Fill & Clean adapter preparation ..................................................................... 146
15.15.Fill time-out error ............................................................................................ 147
15.16.Carousel position error ................................................................................... 148
15.17.Sampling and results trouble shooting ........................................................... 149
15.18.Separator error ............................................................................................... 150
15.19.Reagents ........................................................................................................ 150
15.19.1.Reagents alarm ....................................................................................... 151
15.20.Fill nozzle ....................................................................................................... 151
15.20.1.Fill nozzle does not engage with pipette ................................................. 151
15.20.2.Fill nozzle not at fill position .................................................................... 151
15.20.3.Fill nozzle not at home position ............................................................... 151
15.21.Communications ............................................................................................. 152
15.22.Trouble-shooting ethernet interface ............................................................... 152
15.23.Sampling process stops ................................................................................. 152
15.24.Piercing error .................................................................................................. 153
15.25.Sensor errors .................................................................................................. 153
15.26.Not reading the barcode ................................................................................. 153
15.27.Quality control trouble shooting ...................................................................... 154

Contents
Page 10 Starrsed TL User Manual
Version 1.00 MRN-171-EN
16.APPENDIX FOR STARRSED TL ............................................................................... 157
17.WORK INSTRUCTION STARRSED TL ..................................................................... 178
18.GLOSSARY OF TERMS ............................................................................................ 217
19.INDEX ......................................................................................................................... 219

Introduction
Starrsed TL User Manual Page 11
Version 1.00 MRN-171-EN
1. INTRODUCTION
1.1. Intended use of device
Automated analyser for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) of
human blood samples in conformity with the Westergren standard.
For professional use in medical laboratories only. To be used for all patient populations, not
restricted by age or any other anatomical or physiological particulars.
1.2. Indication for use of device
For screening and follow-up of patients with (suspected) inflammatory conditions.

Introduction
Page 12 Starrsed TL User Manual
Version 1.00 MRN-171-EN
1.3. Instrument overview
The Starrsed Blood Sedimentation Rate Instrument (hereafter called Starrsed TL) is an in vitro
diagnostic medical device that automatically carries out the erythrocyte sedimentation rate analysis
according to the Westergren method, conforming to CLSI approved standard H02-A51 and
recommended by the ICSH2, using closed sample tubes filled with citrate or EDTA blood.
The Starrsed TL is an advanced ESR system that offers many unique features and benefits over
the traditional ESR procedures. Automating this method has the following advantages:
 The Westergren pipettes are always filled to the correct level.
 Using closed sample tubes reduces the possibility of contamination for the user and
environment.
 Standard glass Westergren pipettes are used, in which the measurement can be corrected to a
constant temperature (18 °C Celsius). Even small abnormalities can be detected over a longer
period of time, irrespective of where and when the blood sample was taken.
 Every sedimentation measurement is directly linked to an identified sample, so that a manual
work sheet is unnecessary. Patient ID errors are reduced to a minimum by using the bar-code
reader.
 Patient ID's are provided by the Laboratory Information System.
 The Starrsed TL is designed for integration in track-based laboratory systems.
 In the EDTA mode, the accuracy of dilution of EDTA blood with citrate is considerably better
than manual dilution achieved either by "tipping off" or using evacuated blood collection tubes
pre-filled with citrate solution.
 The data can be send to your Lab Information System.
 The used sedimentation pipettes are automatically washed and dried.
 Minimum sample volume is 1.4 ml
 Windows based System Software, running on an external computer.
References:
(1) CLSI Procedures for the Erytrhocyte Sedimentation Rate Test: Approved Standard - Fifth
edition H02-A5, VOl. 31 No 11; 2011
(2) ICSH review of the measurement of the Erythrocyte sedimentation rate / J. M. Jou, Int. Journal
of Laboratory Hematology 2011 (33), p .125-132

Introduction
Starrsed TL User Manual Page 13
Version 1.00 MRN-171-EN
1.4. Explanation of symbols
The following symbols can be used in this manual and for the instrument:
Warning sign to prevent personal injury due to biohazard.
Warning sign to prevent personal injury due to rotating parts.
Warning sign to prevent personal injury due to sharp objects.
Warning sign to prevent personal injury due to hot surfaces.
Warning sign to prevent personal injury due to electrical shocks.
General warning.
General note.
This symbol indicates a reference to this or other product
documentation

Introduction
Page 14 Starrsed TL User Manual
Version 1.00 MRN-171-EN
1.5. EQAS
EQAS is RR Mechatronics' comprehensive tool to periodically assess the performance of the
Starrsed instrument at your lab. Through EQAS, the test results of the instrument, obtained with
Starrsed Control are objectively compared with a worldwide peer group using the same type of
instrument. Each customer can sign up for our portal, available through our website
http://www.rrmechatronics.com.
1.6. Explanation of available documentation
Manuals for the Starrsed TL are available on three levels: for the operator, the supervisor and the
service engineer.
The following manuals are available:
1. Instructions for Use (IFU)
Intended for the operator: Contains instructions for normal operation, safety, preventive
maintenance and trouble shooting procedures to solve the most common problems. Available
in several languages.
2. User Manual (UM)
Intended for the lab supervisor. Contains information from the IFU and additional information
concerning settings, service, higher maintenance levels and trouble shooting procedures to
solve more complicated problems. Only available in English.
3. Service Manual (SM)
Intended for trained service engineers. Describes maintenance, servicing and repair of the
instrument in detail. Contains detailed descriptions of parts, assembly drawings, modifications,
extended trouble shooting, flow diagrams etc. Only available in English.
4. Installation Manual (IM)
Intended for trained service engineers. Contains instructions and procedures for installation
and start-up. Only available in English.
Manuals are available in PDF and HTML-format and can be downloaded from
http://www.rrmechatronics.com.
1.7. Starrsed line of ESR instruments
The Starrsed line of ESR automated instruments is unique by the fact that it has automated the
Westergren Method and fully complies with the published reference method, including working with
diluted EDTA blood. The Starrsed line offers several types of ESR analyzers. Our solutions range
from tube-based to rack-based to track-based, the latter resulting in the highest level of automation
possible. Laboratories that operate different Starrsed instruments in different capacities are
assured that correlations are precise and fully reliable.
Starrsed ST, Starrsed RS, Starrsed RL and Starrsed TL are instrument names of RR
Mechatronics. Until 2014 the Starrsed ST was called Inversa 24M, the Starrsed RS was called
Auto Compact, the Starrsed RL was called Interrliner (Standalone). RR Mechatronics changed the
product names to benefit better from the worldwide recognizability of the brand name Starrsed.

Introduction
Starrsed TL User Manual Page 15
Version 1.00 MRN-171-EN
1.8. Dilution principle
The principle of adding Diluent to a flow of whole blood is unique. The Starrsed TL has the
capability of monitoring the air displacement during the aspiration cycle. This is called on-line
dilution. The CPU receives data from the airflow sensor and calculates the syringe speed. Diluter
accuracy is ± 3%.
The citrate dilution (4:1) takes place to reduce the influence of HCt (Hematocrit) on the
sedimentation process. Dilution brings the Hct level from 0.45 (considered as a normal level) to
0.36. The ICSH (1993) recommended the use of EDTA samples with a Hct of 0.35 or less. Dilution
errors up to 25% results in a 5% variation in Hct of the prepared sample. This is within the natural
variation in Hct between individual humans and will not have significant influence on the accuracy
of the ESR measurement.
1.9. Sedimentation measurement principle
The automatic reading of the Westergren sedimentation pipettes is carried out by moving an
optical sensor along the pipettes. While the sensor is moving, a reading is made every 0.25 mm.
The sensor is reading the absorption of infrared light through the Westergren pipette filled with
blood. From these readings, values at a number of absorption levels are determined. All absorption
figures are relative to the darkest and lightest reading (darkest = 100 % and the lightest = 0 %
absorption respectively).
By definition the levels are:
87.5% Cells/ plasma separation
75.0% Hazy detection
50.0% Meniscus detection
Graphic showing typical absorption values of a sample

Instrument description
Page 16 Starrsed TL User Manual
Version 1.00 MRN-171-EN
2. INSTRUMENT DESCRIPTION
The Starrsed TL picks a tube from the track and moves the tube to a barcode reading position.
Barcode label is read and checked if an ESR is requested. The tube is then moved to the mix
position into the tube disk and the blood is rotated 12 times, as recommended by the ICSH. When
ready, the tube is moved to aspiration position and the blood is aspirated. Aspiration takes place
via Mechatronics proprietary needle mechanism. Then the tube is moved to the pick up position,
from there the tube is placed back on the track system.
The citrate dilution takes place in a 4+1 ratio and is achieved with ± 3% accuracy.
Eighty-four Westergren pipettes are housed in the carousel. Each is of precision bore glass. After
each cycle, the pipette is cleaned automatically with low foam detergent followed by a drying cycle.
The fill line is back-flushed using diluent.
The temperature is corrected to the standard value of 18°C and ESR's may be read after one hour
or 30 minutes. A foretell one-hour result is presented in the 30-minute mode.
The Starrsed TL can be interfaced bidirectionally with Laboratory Information Management
Systems (LIMS) through a variety of interface protocols.
Results of the test are expressed in millimeters. This data together with the patient ID number is
sent to the Laboratory Information System along with the sedimentation time used (60 or 30
minutes), the temperature and the dilution ratio.

Instrument description
Starrsed TL User Manual Page 17
Version 1.00 MRN-171-EN
The Starrsed TL analyzer consists of the following parts:
ESR analyser unit
 ESR measuring unit with a belt holding 84 precision's bore glass Westergren pipettes.
 Automated dilution of EDTA blood sample with citrate
 Automated measurement of ESR after 30 or 60 minutes
 Automated cleaning and drying of pipettes
Processing unit
 Automated aspiration of the sample tube
 Diluter module
 Automatic mixing of sample tubes before sampling
 Barcode readers for sample identification
Robotic arm
 The robotic arm transports the sample tubes from the track to the processing unit and back to
the track system.
Cabinet
 Reagent containers
 Internal power supply
 Connection bracket for external communication
 Built-in PC with:
 Windows based platform
 Dedicated instrument software
 Network connections
 USB port (on Monitor)
 Reset button for PC (on frame)
Touch screen LCD monitor
Manual sampling device
 A special adapter can be manually filled with sample tubes in a rack to be able to sample with
high priority outside track feeding.
This instrument uses large bulk containers for reagent supply and is delivered with level sensors.

Instrument description
Page 18 Starrsed TL User Manual
Version 1.00 MRN-171-EN
2.1. Technical specifications
Technical specifications for the Starrsed TL:
Instrument model Model name
Starrsed TL
Catalogue number (REF)
TLAX109100
ESR method Westergren method
ICSH J. M. Jou; Int. Journal of Laboratory Hematology
2011; 33: 125-132
CLSI Procedures for the Erythrocyte Sedimentation Rate
Test; Approved Standard- Fifth Edition H02-A5, Vol. 31
No. 11; 2011
Temperature compensation
method
R.W. Manley: J. clin Path (1957), 10, 354
30 minute method R. Rogers: Medical Laboratory World 1994
Allowed blood specimen
types
For EDTA mode: Whole blood with < 1% EDTA
anticoagulant.
Automatic dilution 4 vols. blood + 1 vol. Starrsed Diluent
Reported result mm after 1 hour
Blood volume:
Aspirated blood volume per
sample
1.4-1.6 ml in EDTA mode
Throughput:
30 minute method 135/hour
60 minute method 75/hour
Reagents:
Reagents used QRR 010931 Starrsed Diluent
QRR 010947 Starrsed Disinfectant
QRR 010934 Starrsed Rinse solution
De-ionized water
Track and tube types:
Track types Inpeco FlexLab (Inpeco, Siemens Aptio, Abbott ), GLP
Systems Track
Sample tube types Brands/types as recommended by track supplier.
Closed tubes with concentric cap only.