RR Mechatronics STARRSED RS User manual

Instructions for Use
Starrsed RS
MRN-074-2-EN Version 2.02

Contents
- Document history overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1 - Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.1 - - Intended use of device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.2 - - Indication for use of device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.3 - - Instrument overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.4 - - Explanation of symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.5 - - EQAS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.6 - - Explanation of available documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.7 - - Starrsed line of ESR instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.8 - - Dilution principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.9 - - Sedimentation measurement principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2 - Instrument description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.1 - - PC Operation and User Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.2 - - Technical specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.3 - - Technical specifications contd.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.4 - - Used reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.4.1 - - Starrsed Rinse solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.4.2 - - Starrsed Saline. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.4.3 - - Starrsed Diluent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.4.4 - - Deionized water. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.4.5 - - Starrsed Disinfectant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.4.6 - - Starrsed Cleaning Agent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3 - Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4 - General safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.1 - - Safety warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5 - Starrsed program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.1 - - Software version. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.2 - - Sample screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.2.1 - - Sample screen sections explanation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.2.2 - - Sample screen with keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.2.3 - - Pipette information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.3 - - History screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Contents
MRN-074-2-EN Version 2.02 Starrsed RS 3

5.3.1 - - Display pipette data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.3.2 - - Display Sample history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.3.2.1 - - Display patient results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.3.3 - - ESR Statistics screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.3.4 - - Display rack history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.3.4.1 - - Display rack status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.3.5 - - QC Results screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.3.5.1 - - QC Normal results (table). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.3.5.2 - - QC abnormal results (table). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.3.5.3 - - QC abnormal results (graph). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.3.5.4 - - QC abnormal results screen extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.3.5.5 - - Display sample history (QC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.3.5.6 - - Linked QC IDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.3.5.7 - - QC Result analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.3.6 - - Set start/end date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.3.7 - - History sample analyse option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.3.8 - - History analyse results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.4 - - Reagents screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.4.1 - - New reagent input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.4.1.1 - - New reagent input (cont). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.4.2 - - Display reagent history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.5 - - Maintenance screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.5.1 - - Prime / Clean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.5.1.1 - - Fill and Clean screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.5.1.2 - - End-of-day-wash procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.5.2 - - Check sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.5.3 - - Display error history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.5.4 - - Display maintenance history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.5.5 - - Maintenance info. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.5.6 - - Close . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
5.5.7 - - End-of-day-wash options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
5.5.8 - - End-of-day-wash schedule settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.6 - - Settings screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.7 - - Service screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6 - Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.1 - - Quick start-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Contents
4MRN-074-2-EN Version 2.02 Starrsed RS

6.1.1 - - Power up sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.1.2 - - ESR Unit check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.1.3 - - Priming the fluid system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.2 - - Fill procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6.2.1 - - Liquid levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6.3 - - Checks during operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
6.4 - - Turn off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
6.4.1 - - End-of-day-wash procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
6.4.2 - - Turn off sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
7 - Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
7.1 - - Result Printout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
7.1.1 - - Report 60-Minute mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
7.1.2 - - Report 30 Minute mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
7.2 - - ESR Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
7.2.1 - - ESR Error and Warning code messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
7.3 - - Limit error settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
7.4 - - Reporting range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
7.5 - - Aspect Hazy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
7.5.1 - - Analyser "HAZY" code messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
8 - Quality control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
8.1 - - Control pipettes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
8.2 - - Monitoring measurement quality with Starrsed Control. . . . . . . . . . . . . . . . . . . . . . . . . . 69
8.2.1 - - Limitations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
8.2.2 - - Expected value range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
8.2.3 - - Temperature correction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Contents
MRN-074-2-EN Version 2.02 Starrsed RS 5

8.2.4 - - Usage options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
8.2.5 - - Quality control procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
8.2.6 - - QC Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
8.2.6.1 - - QC Error messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
8.2.6.2 - - QC Result analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
9 - Waste disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
9.1 - - Replacing the waste container. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
10 - Data safety management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
10.1 - - Power failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
11 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
11.1 - - General error procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
11.2 - - Flushing liquids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
11.3 - - Reagents alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
11.4 - - Separator error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
11.5 - - Fill time-out error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
11.6 - - Hazy reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
11.7 - - Leaking pipettes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
11.8 - - Liquid level sensor not sensing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
11.9 - - Air bubbles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
11.9.1 - - Pipette looks like zebra crossing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
11.9.2 - - Foam in column. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
11.9.3 - - One air bubble about 5 mm under meniscus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
11.9.4 - - One air bubble rising in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
11.9.5 - - Small air bubbles rising in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
11.9.6 - - Random air bubbles in pipette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
11.10 - - Quality control troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
12 - Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
12.1 - - Daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
12.2 - - Weekly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
12.2.1 - - Check the sensors in service mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
12.2.2 - - Cleaning waste separator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
12.3 - - Level 4 maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
12.3.1 - - Pump tube replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
12.3.2 - - Replace bacterial filters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
12.3.3 - - Fill-nozzle O-ring replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
12.3.4 - - Fill and clean procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Contents
6MRN-074-2-EN Version 2.02 Starrsed RS

12.4 - - Level 3 maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
12.5 - - Reagents replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
12.6 - - Check or replace sample probe or outer needle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
12.7 - - Cleaning Touch screen display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
13 - Work instruction Starrsed RS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
14 - Appendix for Starrsed RS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
14.1 - - Error list Starrsed RS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
14.2 - - Maintenance schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
15 - Glossary of Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
- Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Contents
MRN-074-2-EN Version 2.02 Starrsed RS 7

Document history overview
MRN--074-2-EN
Issue No Date Revised Section(s) Changes Authorised
2.02 Aug. 2021 Program • Disable pipette option
• Reagent information
mandatory
H. Schavemaker
2.01 Jan. 2020 • General update H. Schavemaker
2.00 June 2017 Introduction
Safety
Program
Maintenance
• Introduction chapters added
• Introduction new software
layout
• Explanation of symbols
• Updated maintenance
instructions and maintenance
information
H. Schavemaker
1.08 November
2015
Instrument
description
• Addition of technical
specifications
• Instrument naming
H. Schavemaker
1.07 October
2014
Introduction
Safety
Appendix
• General safety instructions
• Explanation of
documentation
• Error list revised and E21,
E29, E32 added
H. Schavemaker
1.06 November
2013
History screen
Quality control
Troubleshooting
• Introduction of chapter
Quality Control
H. Schavemaker
1.05 February
2013
History screen
Maintenance screen
Maintenance
Error list
• Addition print result header
• Hazy aspect not suppressed
in case of limit error
• Prime/Clean text
• Maintenance items up to
level 4 included
• Reagent installation
• Error 19 added
H. Schavemaker
1.04 July 2012 Reagents screen
Reporting
Operation
Troubleshooting
• Reagent barcode reader
• Limit error settings
• Air bubble troubleshooting
H.E. van Dijk
1.03 January
2012
• Annual update and
publication
1.02 June 2011 Turn off • It is not a problem if the
Starrsed RS is on all the time.
However,....>
H.E. van Dijk
Document history overview
8MRN-074-2-EN Version 2.02 Starrsed RS

1.01 February
2011
Sample screen
History screen
• Rack pictogram explained H.E. van Dijk
1.00 July 2010 All • Reviewed K. Artz
Preliminary July 2010 All • Manual build from MRN-71 K. Artz
Document history overview
MRN-074-2-EN Version 2.02 Starrsed RS 9

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
10 MRN-074-2-EN Version 2.02 Starrsed RS

1.3 - Instrument overview
The Starrsed Blood Sedimentation Rate Instrument (hereafter called Starrsed RS) is an in vitro diagnostic
medical device that automatically carries out the erythrocyte sedimentation rate (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 RS 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.
▪ In the EDTA mode , the dilution of EDTA blood with citrate is considerably more accurate 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 (LIS/LIMS)
▪ The used sedimentation pipettes are automatically washed and dried.
▪ Minimum sample volume is 1.4 ml for the Starrsed RS.
▪ The Starrsed RS has fully automatic sample loading.
▪ The Rack system can work with a variety of hematology analyzer racks with most common EDTA blood
sample tubes.
▪ The instrument is equipped with a rack adapter for processing a predefined type of rack. It is possible
to exchange the rack adapter for processing other hematology rack types.
▪ Windows based System Software is 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
MRN-074-2-EN Version 2.02 Starrsed RS 11

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
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 .
Introduction
12 MRN-074-2-EN Version 2.02 Starrsed RS

1.6 - Explanation of available documentation
Manuals for the Starrsed RS 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 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 RS 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).
Introduction
MRN-074-2-EN Version 2.02 Starrsed RS 13

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
14 MRN-074-2-EN Version 2.02 Starrsed RS

2
Instrument description
The Starrsed RS can accommodate sample racks from different manufacturers. The individual rack with the
blood samples is snapped into the RR Mechatronics rack adapter and need only be placed on the entry
platform of the Starrsed Rack unit.
The operator simply presses the button "Sample mode".
The instrument picks up the rack, barcode labels are read and the blood is mixed by rotating the rack 8
times, as recommended by the ICSH. Blood is aspirated from the first sample tube. Thereafter the rack is
rotated one time to ensure each blood sample is thoroughly mixed and the sample is picked up to be
aspirated. Aspiration takes place via Mechatronics proprietary double needle mechanism.
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 saline solution.
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 RS 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.
Blanco
Blanco
Blanco
Instrument description
MRN-074-2-EN Version 2.02 Starrsed RS 15

The Starrsed RS analyzer consists of the following units:
ESR analyser unit
▪ ESR measuring instrument with a belt holding 84 precision's bore glass Westergren pipettes.
▪Automated aspiration of the sample tube.
▪ Automated dilution of EDTA blood sample with citrate.
▪ Automated measurement of ESR after 30 or 60 minutes.
▪ Automated cleaning and drying of pipettes.
Starrsed Rack
▪ Add-on unit for sampling and rack handling.
▪ Barcode reader for sample identification.
▪ Rack transport unit.
▪ Automatic mixing of sample tubes before sampling.
▪ Needle unit.
▪ Diluter module.
PC with touch screen LCD monitor
▪Windows based platform
▪ Dedicated instrument software
▪ Optional network connections
▪ USB port
Option:
▪ External barcode reader, which can be connected to the USB port of the ESR analyser unit. This
barcode reader can be used for reagent handling and for ID-input in sample history search.
Starrsed RS with long level sensors
This model uses large bulk containers for reagent supply instead of the 0.5-liter onboard containers. This
means longer operation time without reagent preparation and no cleaning time. This model is delivered with
longer level sensors and special reagents cover assembly.
2.1 - PC Operation and User Interface
The entire operation of the Starrsed RS 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
16 MRN-074-2-EN Version 2.02 Starrsed RS

2.2 - Technical specifications
Technical specifications for the Starrsed RS:
Instrument model Model name
Starrsed RS
Starrsed RS-LS
Catalogue number
(REF)
VERA109900
VERA109910
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
Throughput: (100% ESR requirement on total number of samples)
30 minute method 135/hour
60 minute method 75/hour
Reagents:
Reagents used QRR 010931 Starrsed Diluent
QRR 010947 Starrsed Disinfectant
QRR 010933 Starrsed Saline
QRR 010934 Starrsed Rinse Solution
De-ionized water
Blood volume:
Aspirated blood volume per
sample
1.4 ml in EDTA mode
Rack and tube types:
Instrument description
MRN-074-2-EN Version 2.02 Starrsed RS 17

Rack types Abbott, Bayer, Advia, Beckman Coulter, Horiba, Horiba ABX,
Roche, Siemens, Sysmex
Sample tube types Most commonly used brands/types.
Closed tubes with concentric cap only.
Barcode reader:
Barcode reader type CCD.
Reading capabilities Most common barcode labels
Code39, ITF, Industrial 2 or 5, CodaBar,EAN/UPC, CODE128
Data storage:
Storage medium Hard disk on external PC
Storage capacity indication approx. 5 Mb per 1000 samples (results and raw data)
LIS connectivity:
Communication Ethernet and serial, bi-directional according various protocols
2.3 - Technical specifications contd.
Environment:
Sound level Less than 65 dBA
Environment temperature 18 - 28 °C
Relative humidity 10-90%
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
Rack unit:
Mains voltage 12 Volt DC from the ESR unit
Instrument description
18 MRN-074-2-EN Version 2.02 Starrsed RS

Power consumption 50 VA
Weight 21.5 kg
Dimensions
Table space (incl. PC) 1500x660 mm
Height 770 mm
Weight empty (ESR unit+rack) 70 kg
Table size (Min.)
Width (excl. space for PC) 1100 mm
Width (incl. space for PC) 1500 mm
Depth 660 mm
Instrument description
MRN-074-2-EN Version 2.02 Starrsed RS 19

2.4 - Used reagents
NOTE:
The latest version of the Material Safety Data Sheet (MSDS) of the used reagents can
be found on our web site rrmechatronics.com
2.4.1 - 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).
2.4.2 - Starrsed Saline
Starrsed Saline is a dedicated IVD product, developed exclusively for the automatic cleaning of the needle
and fill-nozzle assembly in Starrsed ESR analyzers. Approximately 1 ml of saline is used for each sample.
This reagent is supplied in a 5-liter container (QRR 010933).
2.4.3 - Starrsed Diluent
Starrsed Diluent is a dedicated IVD product, developed exclusively for the automatic dilution of blood
samples in Starrsed ESR analyzers.
▪ Approximately 0.5 ml Diluent is used for each sample.
▪ Approximately 2.5 ml is used for one Prime cycle.
This reagent is supplied in a 5-liter container (QRR 010931).
The solution should be discarded if it becomes turbid.
If onboard containers are used:
If the diluent does become turbid, clean the diluent bottle thoroughly with 50 ml bleach (containing
approximately 5% Na-hypochlorite) and 950 ml de-ionized water (=5% solution). Make sure that the
container is thoroughly rinsed with de-ionized water after cleaning.
If large cubitainers are used:
Replace the Diluent cubitainer.
2.4.4 - Deionized water
After each aspiration, the fill nozzle is flushed with de-ionized water. The water container must be filled up
when empty.
Add one or two drops of Starrsed Saline to the deionized water to avoid Reagent alarm.
2.4.5 - 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).
Instrument description
20 MRN-074-2-EN Version 2.02 Starrsed RS