Human HumaStar 600 User manual

HumaStar 600
|User Manual
Cat No. 16660/001

REVISION LIST OF THE MANUAL
Rev. /DATE. REVISION DESCRIPTION
01/2007-09 First edition
02/2007-11 Correction of typing errors
03/2008-03 New features of SW 1.7.1 implemented
04/2008-10 New features of SW 1.7.3 implemented
(calibration status, reagent status, ISE module update)
05/2009-01 Typing errors corrected
06/2010-05 New features of SW 1.8.1 implemented
(clot detection, power user, wear, BCR for controls and standards)
07/2011-06 Update for software 1.8.1 r2011.05.30
08/2011-09 Correction dimension
09/2014-12 Adding of System Wash Solution, chapter of ISE module excluded
10/2017-05 Update for Software 2.5.0
SYSTEM VERSION
COPYRIGHT
Copyright 2017, Human Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden, Germa-
ny. All rights reserved.
No part of this documentation may be reproduced in any form, nor processed, copied or distrib-
uted by means of electronic systems, without prior permission of Human GmbH in writing. Since
all precautionary measures were taken into account in producing these operating instructions,
the manufacturer accepts no responsibility for any errors or omissions. This includes any liability
for damage that could arise from possible incorrect operation based on this information. Subject
to changes without notice as result of technical development.
SERVICE UND SUPPORT

CONTENTS
TABLE OF CONTENTS
1 SAFETY INSTRUCTIONS 5
1.1 INTRODUCTION 5
1.2 USER WARRANTY 5
1.3 INTENDED USE OF THE INSTRUMENT [IVD] 6
1.4 GENERAL SAFETY WARNINGS 6
1.5 DISPOSAL MANAGEMENT CONCEPT 7
1.6 INSTRUMENT DISINFECTION 7
1.7 BIOHAZARD WARNING 8
1.8 ADDITIONAL LABELS 8
2 INTRODUCTION 9
3 SYSTEM DESCRIPTION 11
3.1 UNPACKING 11
3.2 INSTALLATION 11
3.2.1 Installation Requirements 11
3.2.2 Electrical connections 12
3.2.3 Hydraulics 12
3.2.4 Handling of biological fluids 13
3.2.5 Computer setup 14
3.2.6 Parameters 15
3.2.7 Tools 23
3.3 PARTS OF THE INSTRUMENT 28
3.3.1 Front view 28
3.3.2 Top view 28
3.3.3 Left side 29
3.3.4 Samples and sample sectors 29
3.3.5 Reagents 30
3.3.6 Barcodes 30
3.3.7 Cuvettes 30
3.4 SOFTWARE FUNCTIONS OVERVIEW 31
3.4.1 Levels of access 31
3.4.2 Data menu 32
3.4.3 Main Screen 33
3.4.4 Quick Key Menus 36

4 GET READY FOR OPERATION 41
4.1 AUTOMATIC OPERATION 41
4.1.1 Clot detector 42
5 ROUTINE TASKS 43
5.1 REAGENTS 43
5.1.1 Reagent tray 43
5.1.2 Loading barcoded reagents, Diluent and Cleaning Solutions 44
5.1.3 Loading non barcoded reagents and solutions 45
5.1.4 Removing reagents and solutions 45
5.1.5 Refilling reagent bottles (only for open channels) 47
5.1.6 Method assignment to trays 47
5.2 SAMPLES 47
5.2.1 Working with patients 48
5.2.2 Defining sample data and tests 49
5.2.3 Removing a sample 50
5.2.4 Removing tests 51
5.2.5 Copy data 51
5.2.6 Loading samples 52
5.2.7 Removing a sample 53
5.2.8 Placing a sector on the tray 53
5.2.9 Removing a sector 54
5.2.10 Loading a STAT 54
5.2.11 Reports 55
5.3 TEST RESULTS 56
5.3.1 Acceptance of Results 57
5.3.2 Reflex Tests 57
5.3.3 Printout of results 57
5.3.4 Cuvette 57
5.4 CALIBRATION 58
5.4.1 Calibrator sets 59
5.4.2 Requesting a calibration 61
5.4.3 Ordering a calibration 63
5.4.4 Calibration acceptance 63
5.4.5 Automatic calibration 64
5.5 REAGENT BLANK 65
5.6 QUALITY CONTROL 67
5.6.1 Creating a control set 69
5.6.2 Requesting a control 71
5.6.3 Processing a control 72

CONTENTS
5.6.4 Processed controls 72
5.7 TWIN QC 75
5.7.1 QC scheduler 78
5.8 WORKING WITH LIS 80
5.9 DEFINITION AND USE OF SAMPLE PROFILES 80
5.9.1 Defining a sample profile 80
6 DEFINITION OF METHODS 81
6.1 METHOD TYPES AND CALCULATIONS 81
6.1.1 Endpoint 82
6.1.2 Fixed Point 83
6.1.3 Kinetics 84
6.2 METHOD PARAMETERS 84
6.2.1 Common parameters 84
6.2.2 Main Page 85
6.2.3 Quantitative 88
6.2.4 Limits 89
6.2.5 Reference classes 91
6.2.6 Advanced features 92
6.2.7 Consumption 94
6.2.8 Reagent substitution 95
6.2.9 Kits 96
6.3 SOLUTIONS 97
6.4 OPTIONS 98
6.5 CALCULATED METHODS 99
6.6 EXTERNAL METHODS 100
6.7 UNITS AND LIMITS 101
6.8 DEVELOPEMENT OF A METHOD 101
7 ISE MODULE CAT.-NO. 16663-03 103
8 MAINTENANCE 105
8.1 SCHEDULER 105
8.1.1 Schedule 106
8.1.2 Status 107
8.2 DAILY MAINTENANCE 108
8.2.1 Inspection and Cleaning of Probes 108
8.2.2 Check and Replace System Solutions 108
8.2.3 Empty Waste Bottle 109
8.2.4 Hydraulic Testing – System Flush 109

8.3 WEEKLY MAINTENANCE 110
8.3.1 Intensive Cuvette Cleaning 110
8.3.2 Cuvette Water Blank 111
8.3.3 Service Backup 111
8.4 MONTHLY MAINTENANCE 112
8.4.1 Photometer Calibration 112
8.4.2 Washer Volume Calibration 113
8.4.3 Clean System Bottles 114
8.4.4 Intensive Washer Cleaning 115
8.5 MAINTENANCE ON DEMAND 116
8.5.1 Cuvette Change 116
8.5.2 Lamp Replacement 117
8.5.3 Pump tube replacement 117
8.6 COUNTERS 117
9 TROUBLESHOOTING 119
9.1 MESSAGES AND WARNINGS 119
9.2 VISIBLE FAULTS 119
9.2.1 General faults 119
9.2.2 Measurement inconsistencies 120
10 APPENDIX 123
10.1 TECHNICAL SPECIFICATION 123

Safety InStructIonS 5
1 SAFETY INSTRUCTIONS
1.1 Introduction
This manual is considered as a part of the instrument; it has to be at the oper-
ator’s hand as well as at the maintenance operator’s availability. For accurate
installation, use and maintenance, please read the following instructions care-
fully. In order to avoid instrument damage or personal injury, carefully read the
”GENERAL SAFETY WARNINGS”, describing the suitable operating procedures. In
case of breakdowns or any troubles with the instrument, apply to the local Tech-
nical Service.
1.2 User Warranty
HUMAN warrants that instruments sold by one of its authorised representa-
tives shall be free of any defect in material or workmanship, provided that this
warranty shall apply only to defects which become apparent within one year
from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item at no
charge, except for transportation expenses to the point of repair.
This warranty excludes the HUMAN representative from liability to replace any
item considered as expendable in the course of normal usage, e.g.: lamps, valves,
syringes, glassware, fuses, diskettes, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty
if the product is not used in accordance with the manufacturer‘s instructions,
altered in any way not specified by HUMAN, not regularly maintained, used with
equipment not approved by HUMAN or used for purposes for which it was not
designed.
HUMAN shall be relieved of any obligation under this warranty, unless a com-
pleted installation / warranty registration form is received by HUMAN within
15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any
damage so incurred shall be reported to the freight carrier for settlement or
claim.

HumaStar 600 | User manual
6
1.3 Intended Use of the Instrument [IVD]
The instrument is intended for in vitro diagnostic application by professional
users. It has to be used for the expected purposes and in perfect technical con-
ditions, by qualified personnel, in working conditions and maintenance opera-
tions as described in this manual, according to the GENERAL SAFETY WARNINGS.
This manual contains instructions for professional qualified operators.
The external PC must not be used for purposes other than those designated in
this manual. The analyzer is designated for indoor use only. Recommendation
provided in the leaflet for all reagents and consumables have to be observed.
1.4 General Safety Warnings
Use only chemical reagents and accessories specified and supplied by HUMAN
and/or mentioned in this manual. Place the product so that it has proper ven-
tilation.
The instrument should be installed on a stationary flat working surface, free
from vibrations.
Do not operate in area with excessive dust.
Work at room temperature and humidity, according to the specifications listed
in this manual.
Do not operate this instrument with covers and panels removed.
Only use the power cord specified for this product, with the grounding conduc-
tor of the power cord connected to earth ground.
Use only the fuse type and rating specified by the manufacturer for this instru-
ment, use of fuses with improper ratings may pose electrical and fire hazards.
To avoid fire or shock hazard, observe all ratings and markings on the instru-
ment.
Do not power the instrument in potentially explosive environment or at risk of
fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument
and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may
become damaged. It is recommended always to wear protective apparel and eye
protection while using this instrument. Respective warning symbols, if appear-
ing in this manual, should be carefully considered.