Human HumaCount 60TS User manual

HumaCount 60TS
|User Manual
16420/601

REVISION LIST OF THE MANUAL
Rev. /DATE REVISION DESCRIPTION
01/2010-03 First edition
02/2010-07 Update for software 1.4
SYSTEM VERSION
HumaCount 60TS with software version 1.4 .
COPYRIGHT
Copyright 2010, Human GmbH, Wiesbaden, Germany. All rights reserved.
No part of this documentation may be reproduced in any form, nor processed, copied or
distributed 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
2 SYSTEM DESCRIPTION 11
2.1 THE INSTRUMENT 11
2.1.1 Patient Testing 11
2.1.2 Reagents 12
2.1.3 Technical Operation 12
2.1.4 Calibration 13
2.2 UNPACKING AND INSTALLATION 13
2.2.1 Environmental Factors 14
2.2.2 Turning the Instrument ON, MAIN Menu 16
2.2.3 Turning the Instrument OFF 17
2.2.4 Preparing for Shipment 18
2.2.5 Handling in Emergency 19
2.2.6 Replacing Paper into the Printer 20
2.2.7 Accessories 21
2.3 INSTRUMENT FEATURES 22
2.4 PARTS OF THE ANALYZER 23
2.5 CONTROL MATERIAL 24
2.6 MENU SYSTEM 24
2.6.1 Touch Screen Calibration 24
2.6.2 Navigating in the Menu System 25
2.6.3 Menu Structure 26
2.7 METHOD OF OPERATION 27
2.7.1 Impendance method 27
2.7.2 Principle of HGB Measurement 28
2.7.3 Parameters 28
2.7.4 Absolute and Linearity Ranges of Parameters 30
2.7.5 Quality Control 30

3 ROUTINE UTILIZATION AND MEASUREMENT 35
3.1 SAMPLE HANDLING 35
3.2 SAMPLE ANALYSIS 37
3.2.1 Sample Preparation 37
3.2.2 Running a (new) Sample 38
3.2.3 Results 41
3.2.4 Warning flags 41
3.2.5 Paramter Limits (Normal Ranges) 44
3.2.6 Blank Measurement 44
3.2.7 Using Pre-Diluted Mode 45
3.3 THE MEASUREMENT PROCESS 46
3.3.1 Control Panels 46
3.3.2 Display 47
3.3.3 Touch screen 47
3.4 PRINTING 47
3.4.1 Printouts 47
4 ADVANCED OPERATION 51
4.1 DIAGNOSTICS 51
4.1.1 Device Infomation 51
4.1.2 Self Test 52
4.2 DATABASE 53
4.2.1 Database Service 54
4.2.2 The Filter / Select Function 56
4.2.3 Printing Records 57
4.2.4 Manage Records 57
4.3 CALIBRATION 58
4.3.1 Calibration with factors 59
4.3.2 Calibration by measurement 59
4.4 SETTINGS 60
4.4.1 Printer Settings 61
4.4.2 General Settings 63
4.4.3 Measurement 63
4.4.4 Date and Time 66
4.4.5 Multi User Mode 67
5 MAINTENANCE 71
5.1 CLEANING 71
5.2 REAGENT STATUS 73
5.2.1 How to Empty Waste Container 74

CONTENTS
5.2.2 Neutralization of Waste 74
5.3 WEEKLY USER MAINTENANCE 76
5.3.1 Cleaning Needle Washing Head 76
6 TROUBLESHOOTING 77
6.1 REGULAR TROUBLESHOOTING PROCEDURES 77
6.2 SPECIFICATIONS 77
6.3 FLUIDIC SCHEMATICS 79
7 APPENDIX 81
7.1 REAGENT SOLUTIONS AND CONSUMPTION 81

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
operator’s hand as well as at the maintenance operator’s availability. For accu-
rate installation, use and maintenance, please read the following instructions
carefully. In order to avoid instrument damage or personal injury, carefully read
the ”GENERAL SAFETY WARNINGS”, describing the suitable operating proce-
dures. In case of breakdowns or any troubles with the instrument, apply to the
local Technical Service.
1.2 User Warranty
HUMAN warrants that instruments sold by one of its authorised
representativesshallbefreeofanydefectinmaterialorworkmanship,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,
alteredinanywaynotspecifiedbyHUMAN,notregularlymaintained,usedwith
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
completed 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.

HumaCount 60TS | User manual
6
1.3 Intended Use of the Instrument [IVD]
The instrument is intended for in vitro diagnostic application by professio-
nal users. It has to be used for the expected purposes and in perfect technical
conditions, by qualified personnel, in working conditions and maintenance
operations as described in this manual, according to the GENERAL SAFETY
WARNINGS. This manual contains instructions for professional qualified
operators.
1.4 General Safety Warnings
Use only chemical reagents and accessories specified and supplied by
HUMANand/ormentionedinthismanual.Placetheproductsothatithasproper
ventilation.
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
conductor of the power cord connected to earth ground.
Use only the fuse type and rating specified by the manufacturer for this
instrument, use of fuses with improper ratings may pose electrical and fire ha-
zards.
To avoid fire or shock hazard, observe all ratings and markings on the
instrument.
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
appearing in this manual, should be carefully considered.