RR Mechatronics STARRSED TL User manual

User Manual
Starrsed TL
MRN-171-EN Version 1.01

Contents
- Copyright. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
- Document history overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1 - Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.1 - - Intended use of device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.2 - - Indication for use of device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.3 - - Instrument overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1.4 - - Explanation of symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1.5 - - EQAS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.6 - - Explanation of available documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.7 - - Starrsed line of ESR instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.8 - - Dilution principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.9 - - Sedimentation measurement principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2 - Instrument description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.1 - - Technical specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.2 - - Accessory kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.3 - - Used reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.3.1 - - Starrsed Rinse solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.3.2 - - Starrsed Diluent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.3.3 - - Deionized water. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.3.4 - - Starrsed Disinfectant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.3.5 - - Starrsed Cleaning Agent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3 - General safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.1 - - Safety warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.2 - - Moving parts warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4 - Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5 - Standard Operating Procedures (S.O.P.). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.1 - - Basics of bio safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.2 - - S.O.P. for working with bio hazardous materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Contents
MRN-171-EN Version 1.01 Starrsed TL 3

5.2.1 - - Facts and definitions:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.2.2 - - Medical requirements:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.2.3 - - General laboratory practices:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.2.4 - - Specific laboratory practices and requirements:. . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.3 - - E.C. Declaration Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5.4 - - Labels and stickers on containers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.4.1 - - Stickers of the reagents containers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6 - Starrsed TL program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
6.1 - - Software version. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.2 - - Sample screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.2.1 - - Sample screen sections explanation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6.2.2 - - Sample screen with keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
6.2.3 - - Pipette information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.3 - - History screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.3.1 - - Display pipette data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.3.2 - - Display Sample history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.3.2.1 - - Display patient results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6.3.2.2 - - History sample analyse option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.3.2.3 - - Set start/end date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6.3.3 - - ESR Statistics screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.3.4 - - QC Results screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.3.4.1 - - QC Normal results (table). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6.3.4.2 - - QC abnormal results (table). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.3.4.3 - - QC abnormal results (graph). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
6.3.4.4 - - QC abnormal results screen extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.3.4.5 - - Display sample history (QC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.3.4.6 - - Linked QC IDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.3.4.7 - - QC Result analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
6.3.5 - - History analyse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
6.3.6 - - History analyse results dilution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.3.7 - - History aspect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.3.8 - - History analyse error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6.3.9 - - History analyse warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Contents
4MRN-171-EN Version 1.01 Starrsed TL

6.4 - - Reagents screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
6.4.1 - - Display reagent history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.4.2 - - New reagent input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.4.2.1 - - New reagent input (cont). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.5 - - Maintenance screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6.5.1 - - Prime / Clean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
6.5.1.1 - - Fill and Clean screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.5.1.2 - - End-of-day-wash procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
6.5.2 - - Check sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
6.5.2.1 - - Check sensors in service mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
6.5.3 - - Display error history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
6.5.4 - - Display maintenance history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
6.5.5 - - Maintenance info. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
6.5.6 - - Close . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
6.5.7 - - End-of-day-wash options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
6.5.8 - - End-of-day-wash schedule settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.6 - - General settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.6.1 - - Display settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
6.6.2 - - Carousel control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6.6.2.1 - - Pipette flow tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
6.6.2.2 - - Set new rinse position. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.6.3 - - Diluter settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
6.6.3.1 - - Dilution adjustment 60 till 140%. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
6.6.3.2 - - Dilution error detection 0 till 25%. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
6.6.3.3 - - Auto dilution adjust. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
6.6.3.4 - - Diluent flow check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
6.6.4 - - Limit error settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
6.6.5 - - QC Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
6.7 - - Service screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Contents
MRN-171-EN Version 1.01 Starrsed TL 5

6.7.1 - - TLAX settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
6.7.1.1 - - Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
6.7.1.2 - - Service Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
6.7.2 - - LIMS settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
6.7.2.1 - - Set LIMS communication settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
6.7.2.2 - - Set protocol settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
6.7.3 - - ESR unit settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
6.7.4 - - Manual control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
6.7.4.1 - - Needle Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
6.7.4.2 - - Valve control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
6.7.5 - - Display error history (Service). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
6.7.6 - - Display maintenance history (Service). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
7 - Getting started. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
7.1 - - Limit filter settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
7.2 - - Liquid levels sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
7.3 - - Reagents preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
7.3.1 - - Starrsed Cleaning Agent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
8 - Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
8.1 - - Result Printout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
8.1.1 - - Report 60-Minute mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
8.1.2 - - Report 30 Minute mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
8.2 - - ESR Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
8.2.1 - - ESR Error and Warning code messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
8.3 - - Limit error settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
8.4 - - Reporting range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
8.4.1 - - Reporting range minumum value. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
8.5 - - Aspect Hazy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
9 - Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
9.1 - - Quick start-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Contents
6MRN-171-EN Version 1.01 Starrsed TL

9.1.1 - - Power up sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
9.1.2 - - Check list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
9.1.3 - - Liquid levels sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
9.2 - - Checks during operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
9.3 - - Manual sampling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
9.4 - - Priming the fluid system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
9.5 - - End of day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
9.5.1 - - End-of-day-wash procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
9.5.2 - - Turn off sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
10 - Quality control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
10.1 - - Control pipettes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
10.2 - - Monitoring measurement quality with Starrsed Control. . . . . . . . . . . . . . . . . . . . . . . . 118
10.2.1 - - Limitations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
10.2.2 - - Expected value range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
10.2.3 - - Temperature correction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
10.2.4 - - Usage options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
10.2.5 - - Quality control procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
10.2.6 - - QC Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
10.2.6.1 - - QC Error messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
10.2.6.2 - - QC Result analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
11 - ESR analyser unit system messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
11.1 - - System messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
11.2 - - Test messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
11.3 - - System time-out <xxxx>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
11.4 - - Error Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
12 - Waste handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
12.1 - - Waste line connection to central waste system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
13 - General maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
13.1 - - Daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
13.2 - - Weekly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
13.2.1 - - Check the sensors in service mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
13.2.2 - - Cleaning liquid separator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
13.3 - - Level 4 maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Contents
MRN-171-EN Version 1.01 Starrsed TL 7

13.3.1 - - Pump tubes replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
13.3.2 - - Replace bacterial filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
13.3.3 - - Fill-nozzle O-ring replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
13.3.4 - - Fill and clean procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
13.3.5 - - Replace needle O-ring and check needle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
13.4 - - Level 3 maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
13.5 - - Level 2 maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
13.6 - - Level 1 maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
13.7 - - Replace needle O-ring and check needle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
13.8 - - Reagents replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
13.9 - - Cleaning Touch screen display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
14 - Data safety management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
14.1 - - Power failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
14.2 - - PC output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
14.3 - - Specifications for the RS232 port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
14.4 - - Folder Structure on PC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
15 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
15.1 - - Peristaltic pumps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
15.1.1 - - Rinse solution not primed through the system. . . . . . . . . . . . . . . . . . . . . . . . . . 141
15.1.2 - - Rinse solution spilling over the instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
15.1.3 - - Rinse and Saline pump failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
15.1.4 - - Needle assembly not washed after aspiration (17). . . . . . . . . . . . . . . . . . . . . . . 143
15.1.5 - - Pipettes not dry after washing and drying cycle. . . . . . . . . . . . . . . . . . . . . . . . . 143
15.2 - - Liquid level sensor not sensing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
15.3 - - Flushing liquids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
15.3.1 - - De-ionized water. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
15.3.2 - - Disinfectant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
15.4 - - Diluter system not sufficiently primed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
15.5 - - Diluter errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
15.6 - - Air bubbles entering the Diluent system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
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8MRN-171-EN Version 1.01 Starrsed TL

15.7 - - Vacuum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
15.7.1 - - Vacuum stabilisation problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
15.7.2 - - Vacuum error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
15.8 - - Needle system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
15.8.1 - - Needle not in home position (17). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
15.8.2 - - Sample probe fails to go down. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
15.9 - - Leaking pipettes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
15.10 - - Air bubbles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
15.10.1 - - Foam in column. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
15.10.2 - - Pipette looks like zebra crossing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
15.10.3 - - One air bubble about 5 mm under meniscus. . . . . . . . . . . . . . . . . . . . . . . . . . 151
15.10.4 - - One air bubble rising in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
15.10.5 - - Small air bubbles rising in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
15.10.6 - - Random air bubbles in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
15.11 - - Rinse nozzle (wash station) alignment errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
15.12 - - Hazy reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
15.12.1 - - Hazy reports after cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
15.13 - - Contaminated instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
15.14 - - Fill & Clean adapter preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
15.15 - - Fill time-out error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
15.16 - - Carousel position error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
15.17 - - Sampling and results troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
15.18 - - Separator error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
15.19 - - Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
15.19.1 - - Reagents alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
15.20 - - Fill nozzle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
15.20.1 - - Fill nozzle does not engage with pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
15.20.2 - - Fill nozzle not at fill position. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
15.20.3 - - Fill nozzle not at home position. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
15.21 - - Communications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
15.22 - - Troubleshooting ethernet interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
15.23 - - Sampling process stops. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
15.24 - - Piercing error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
15.25 - - Sensor errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
15.26 - - Not reading the barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
15.27 - - Quality control troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
15.28 - - Appendix - Maintenance schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
15.29 - - Appendix - Error list Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Contents
MRN-171-EN Version 1.01 Starrsed TL 9

16 - Appendix for Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
16.1 - - Spare part list Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
16.2 - - Appendix - Tube connections Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
16.3 - - Appendix - PC connections for Starrsed TL (Windows 10). . . . . . . . . . . . . . . . . . . . . . 183
16.4 - - Article reference list Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
16.5 - - Appendix - Default settings Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
17 - Work instruction Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
18 - Glossary of Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
- Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
Contents
10 MRN-171-EN Version 1.01 Starrsed TL

Copyright
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Manufacturer: RR Mechatronics Manufacturing B.V.
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
Internet: 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
Copyright
MRN-171-EN Version 1.01 Starrsed TL 11

Document history overview
MRN-171-EN
Issue No Date Revised Section(s) Changes Authorised
1.01 Jan. 2020 Introduction
Trouble shooting
Appendix
• Minor text changes
• Modification of spare parts
• Introduction of new ordering
numbers
H. Schavemaker
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
Document history overview
12 MRN-171-EN Version 1.01 Starrsed TL

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
MRN-171-EN Version 1.01 Starrsed TL 13

1.3 - Instrument overview
The Starrsed Blood Sedimentation Rate Instrument (hereafter called Starrsed TL) is an in vitro diagnostic
(see on page 245) medical device that automatically carries out the erythrocyte sedimentation rate (see on
page 245) (ESR) 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.
•Sample ID's are read by the barcode reader and each sedimentation measurement is linked to the
identified sample, so that a manual work sheet is unnecessary.
•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
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.
Introduction
14 MRN-171-EN Version 1.01 Starrsed TL

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
MRN-171-EN Version 1.01 Starrsed TL 15

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 .
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
troubleshooting procedures to solve the most common problems. Available in several languages.
2. User Manual (UM)
(If available) Intended for the lab supervisor. Contains information from the IFU and additional
information concerning settings, service, higher maintenance levels and troubleshooting 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
troubleshooting, 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
www.support.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.
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%
Introduction
16 MRN-171-EN Version 1.01 Starrsed TL

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 performed by moving an optical sensor
along the pipettes. While the sensor is moving, it is taking a reading 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
Introduction
MRN-171-EN Version 1.01 Starrsed TL 17

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.
The Starrsed TL analyzer consists of the following parts:
ESR analyser unit
Instrument description
18 MRN-171-EN Version 1.01 Starrsed TL

•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
MRN-171-EN Version 1.01 Starrsed TL 19

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
Instrument description
20 MRN-171-EN Version 1.01 Starrsed TL