RR Mechatronics STARRSED TL User manual

Instructions for Use
Starrsed TL
MRN-164_2-EN Version 1.08

Contents
- Document history overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1 - Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.1 - - Intended use of device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.2 - - Indication for use of device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3 - - Instrument overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4 - - Explanation of symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.5 - - EQAS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.6 - - Explanation of available documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.7 - - Starrsed line of ESR instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.8 - - Dilution principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.9 - - Sedimentation measurement principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2 - Instrument description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1 - - PC Operation and User Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.2 - - Technical specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3 - - Used reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.1 - - Starrsed Rinse solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.2 - - Starrsed Diluent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.3 - - Deionized water. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.4 - - Starrsed Disinfectant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.5 - - Starrsed Cleaning Agent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3 - General safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.1 - - Safety warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.2 - - Moving parts warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.3 - - Status signals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4 - Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5 - Starrsed TL program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.1 - - Software version. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.2 - - Sample screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.2.1 - - Sample screen sections explanation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.2.2 - - Sample screen with keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.2.3 - - Pipette information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.3 - - History screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Contents
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5.3.1 - - Display pipette data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5.3.2 - - Display Sample history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.3.2.1 - - Display patient results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.3.3 - - ESR Statistics screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.3.4 - - QC Results screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.3.4.1 - - QC Normal results (table). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.3.4.2 - - QC abnormal results (table). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.3.4.3 - - QC abnormal results (graph). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.3.4.4 - - QC abnormal results screen extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.3.4.5 - - Display sample history (QC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.3.4.6 - - Linked QC IDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.3.4.7 - - QC Result analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.3.5 - - History sample analyse option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.3.6 - - Set start/end date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.3.7 - - History analyse results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.4 - - Reagents screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.4.1 - - Display reagent history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.4.2 - - New reagent input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5.4.2.1 - - New reagent input (cont). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5.5 - - Maintenance screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.5.1 - - Prime / Clean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.5.1.1 - - Fill and Clean screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.5.1.2 - - End-of-day-wash procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.5.2 - - Check sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.5.3 - - Display error history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.5.4 - - Display maintenance history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.5.5 - - Maintenance info. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.5.6 - - Close . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.5.7 - - End-of-day-wash options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.5.8 - - End-of-day-wash schedule settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.6 - - Settings screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.7 - - Service screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6 - Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.1 - - Quick start-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Contents
4MRN-164_2-EN Version 1.08 Starrsed TL

6.1.1 - - Check list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.1.2 - - Power up sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.1.3 - - ESR Unit check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.1.4 - - Priming the fluid system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.2 - - Liquid levels sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6.3 - - Checks during operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6.4 - - Fill procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6.5 - - Manual sampling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6.6 - - End of day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.6.1 - - End-of-day-wash procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.6.2 - - Turn off sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.7 - - Control pipettes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
7 - Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
7.1 - - Result Printout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
7.1.1 - - Report 60-Minute mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
7.1.2 - - Report 30 Minute mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
7.2 - - ESR Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
7.2.1 - - ESR Error and Warning code messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
7.2.2 - - Reporting range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
7.3 - - Limit error settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
7.4 - - Reporting range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
7.5 - - Aspect Hazy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
8 - Waste handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
9 - Data safety management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
9.1 - - Power failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10 - Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
10.1 - - Daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
10.2 - - Weekly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
10.2.1 - - Check the sensors in service mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
10.2.2 - - Blood spill removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
10.2.3 - - Cleaning liquid separator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
10.3 - - Level 4 maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Contents
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10.3.1 - - Replace bacterial filters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
10.3.2 - - Fill-nozzle O-ring replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
10.3.3 - - Fill and clean procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
10.3.4 - - Replace needle O-ring and check needle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
10.3.5 - - Cleaning Liquid sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
10.4 - - Pump tubes replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
10.5 - - Reagents replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
10.6 - - Cleaning Touch screen display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
11 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
11.1 - - General error procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
11.2 - - Flushing liquids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
11.3 - - Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
11.3.1 - - Reagents alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
11.4 - - Separator error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
11.5 - - Fill time-out error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
11.6 - - Hazy reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
11.7 - - Leaking pipettes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
11.8 - - Liquid level sensor not sensing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
11.9 - - Sampling and results troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
11.10 - - Robot arm error - general procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
11.11 - - Air bubbles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
11.11.1 - - Pipette looks like zebra crossing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
11.11.2 - - Foam in column. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
11.11.3 - - One air bubble about 5 mm under meniscus. . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
11.11.4 - - One air bubble rising in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
11.11.5 - - Small air bubbles rising in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
11.11.6 - - Random air bubbles in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
11.12 - - Quality control troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
12 - Work instruction Interrliner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
13 - Appendix for Interrliner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
13.1 - - Appendix - Maintenance schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
13.2 - - Spare part list Starrsed TL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
13.3 - - Appendix - Error list Interrliner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
13.4 - - Appendix - List of supported tube types Interrliner. . . . . . . . . . . . . . . . . . . . . . . . . . . 134
14 - Glossary of Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Contents
6MRN-164_2-EN Version 1.08 Starrsed TL

- Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Contents
MRN-164_2-EN Version 1.08 Starrsed TL 7

Document history overview
MRN-164_2-EN
Issue No Date Revised Section(s) Changes Authorised
1.08 Jan. 2020 • General update H. Schavemaker
1.07 Oct. 2018 Maintenance screen
Error List
• Introduction of liquid sensor
• Software version 6.11
• E270-272 added
H. Schavemaker
1.06 Nov. 2017 Operation
Troubleshooting
• Introduction of manual rack input
• Software version 6.09
• Minor corrections
H. Schavemaker
1.05 April 2017 Introduction • Addition of new chapters H. Schavemaker
1.04 January
2017
all • Model TLAX109100 items added
• Minor corrections
H. Schavemaker
1.03 August
2016
Introduction
Maintenance screen
History screen
Appendix
• Revised specifications
• Customised weekdays for End-of-
day-wash
• Send QC results to LIMS added
• Revised Error list
H. Schavemaker
1.02 April 2016 Instrument description
Reporting
all
• Rationale of dilution
• ESR Error reporting
• Minor corrections
H. Schavemaker
1.01 March 2016 all • Fill and clean procedure with
adapter
• Minor corrections
H. Schavemaker
1.00 Feb. 2016 • First issue H. Schavemaker
Document history overview
8MRN-164_2-EN Version 1.08 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
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1.3 - Instrument overview
The Starrsed Blood Sedimentation Rate Instrument (hereafter called Interrliner) is an in vitro diagnostic (see
on page 135) medical device that automatically carries out the erythrocyte sedimentation rate (see on page
135) (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 Interrliner 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 Interrliner 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.
Warning sign to prevent personal injury due to rotating parts.
Introduction
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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
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 Interrliner are available on three levels: for the operator, the supervisor and the service
engineer.
The following manuals are available:
Introduction
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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 Interrliner 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 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
Introduction
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Graphic showing typical absorption values of a sample
Introduction
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2
Instrument description
The Interrliner 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 Interrliner 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 Interrliner 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
Instrument description
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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.
2.1 - PC Operation and User Interface
The entire operation of the Interrliner is driven by a personal computer with Windows operating system. The
user interface is intuitive and can be activated via the keyboard or the optional touch screen. All the data
from each sample, including the raw measuring data and a pictorial representation of the pipette, is stored
and may be retrieved later if needed.
The Main screen shows which pipettes are in use. The section in the middle of the layout gives the sample
number and status for each pipette including "time to go" before the result is due.
A pictorial representation of the pipette at the measuring position and a graph of the optical density over the
length of the entire pipette is shown on the side. This data is retained in memory for subsequent retrieval if
required.
Instrument description
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2.2 - Technical specifications
Technical specifications for the Interrliner:
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.
Instrument description
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Barcode reader:
Barcode reader type Image based
Reading capabilities
Most common barcode labels
Code39, ITF, Industrial 2 or 5, CodaBar,EAN/UPC, CODE128
Total power specifications
Mains voltage 100/230V, 50/60 Hz
Fuse (20 x 5 mm) Slow blow 230V, 2.5 Amp / 115 V, 5 Amp
Power consumption Standby 60 VA / Maximum 500 VA
Heat output Standby 70 Watt / Operation 360 Watt
Environment:
Sound level
Less than 65 dBa
Environment temperature
18 - 35 °C
Relative humidity
10-90%
Total dimensions
Minimum Working space 1700x1100 mm
Total height (cabinet) 1340 mm
Weight empty 140 kg
LIS connectivity:
Communication Ethernet (TCP/IP), bi-directional according various protocols
Data storage:
Storage medium Hard disk on external PC
Storage capacity indication approx. 5 Mb per 1000 samples (results and raw data)
Instrument description
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2.3 - Used reagents
2.3.1 - Starrsed Rinse solution
Starrsed Rinse solution is a dedicated IVD product, developed exclusively for automatic rinsing of the
Westergren pipettes in Starrsed ESR analyzers.
This reagent is supplied in a 20- liter container (QRR 010934).
2.3.2 - Starrsed Diluent
Starrsed Diluent is a dedicated IVD product, developed exclusively for the automatic dilution of blood
samples in Starrsed ESR analyzers.
▪ Each blood sample is automatically diluted with Starrsed Diluent
▪ Starrsed Diluent is used after each sample for cleaning the needle and fill nozzle assembly
This reagent is delivered in a 5-liter container (QRR 010931).
The solution should be discarded if it becomes turbid.
If the Diluent does become turbid, replace the Diluent container.
2.3.3 - Deionized water
After each aspiration, the fill nozzle is flushed with de-ionized water. The water container is a 5-liter plastic
container and must be filled up when empty.
If the deionized water comes up with an alarm with a filled container add then one or two drops of Starrsed
Diluent to the deionized water to avoid reagent alarm.
2.3.4 - Starrsed Disinfectant
Starrsed Disinfectant is a dedicated IVD product, developed exclusively for automatic disinfection of the
waste system of Starrsed ESR analyzers.
This reagent is delivered in a 5-liter container (QRR 010947).
2.3.5 - Starrsed Cleaning Agent
Starrsed Cleaning Agent is used to remove protein deposition from the Westergren pipettes of Starrsed ESR
analyzers.
Starrsed Cleaning Agent needs to be prepared for a cleaning procedure which is used in level 4
maintenance.
Starrsed Cleaning agent is supplied in 100 ml bottles.
QRR010905: 1 bag of 2 bottles
Instrument description
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3
General safety information
The instrument described in this manual is designed to be used by properly trained personnel only. For the
correct and safe use of this instrument it is essential that both operating and servicing personnel follow
generally accepted safety procedures in addition to the safety precautions specified in this manual.
▪ Execute your work according to this manual. Read the instructions before operating the instrument.
Observe all cautionary markings in the manual and on the instrument. Keep this manual for future
reference.
▪ Follow the bio-safety procedures when working with blood-contaminated parts.
▪ Be cautious to prevent stinging during cleaning or replacing the needle assembly.
▪ Repair can only be executed by trained and qualified personnel.
▪ Wear protective clothing.
▪ When the instrument is running it is not allowed to:
▪ Open and remove safety covers.
▪ Touch moving parts.
▪ It is not allowed to give access to the instrument to a non-authorised person at any time.
▪ Whenever it is likely that safety-protection has been impaired, the instrument must be made
inoperative and be secured against any unintended operation. The matter should then be referred to
qualified technicians.
▪ Safety protection is likely to be impaired if, for example, the instrument fails to perform the intended
measurements or shows visible damage or unusual smells, smoke, liquids are flowing out.
3.1 - Safety warning
When there was an incident with the Interrliner which caused damage to the instrument, please notify your
superior and your local equipment dealer before you continue using the instrument.
Example:
▪ A collision with a moving object or a person.
▪ Something falling on the instrument.
▪ Liquids spilling into the instrument.
3.2 - Moving parts warning
Do not open the safety cover during sampling! Some components are moving to another
position before operation finally stops and sample mode is automatically switched OFF.
Switch "Sample mode" always OFF before opening the cover for any reason.
General safety information
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3.3 - Status signals
Note the instrument status indicator on top of the instrument:
▪ Orange: the instrument is at standby-mode and/or is operating in the service mode
▪ Green: the instrument is processing samples, do not open the cover
▪ Red: an error has occurred, check error message on the monitor
Note the rack input status indicator (at the front of the cabinet) for safe use of the manual rack input:
During processing three coloured signals are used after activating manual input:
▪ Green: manual rack input can be started
▪ Orange: the instrument is performing another process, please wait
▪ Red: the sampling process is in progress, do not remove rack or tubes
General safety information
20 MRN-164_2-EN Version 1.08 Starrsed TL