Human HumaCount 30TS Manual de usuario

HumaCount 30TS and 60TS
|Service Manual
16420/302


REVISION LIST OF THE MANUAL
Rev. /DATE REVISION DESCRIPTION
01/2010-09 First edition
SYSTEM VERSION
HumaCount 60TS and HumaCount 30TSwith software version 1.2 .
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 6
1.4 GENERAL SAFETY WARNINGS 6
1.5 DISPOSAL MANAGEMENT CONCEPT 7
1.6 INSTRUMENT DISINFECTION 7
1.7 BIOHAZARD WARNING 8
2 INTRODUCTION 11
2.1 NAME AND SERIAL NUMBER 11
2.2 INTEGRATED SOFTWARE 11
3 FUNCTIONAL DESCRIPTION 13
3.1 MAIN ELECTRONIC PARTS OF THE ANALYZERS 13
3.1.1 Counting chamber with electrodes and measuring aperture 15
3.1.2 HGB Measuring Head 16
3.1.3 Cell Counter Amplifier Board – HC30TS 16
3.1.4 Cell Counter Amplifier Board – HC60TS 17
3.1.5 MAIN CPU Board 19
3.1.6 Dimm-PC* Module 22
3.1.7 Opto sensors 22
3.1.8 Valve boards 23
3.1.9 TFT Display and START button Board 23
3.1.10 External Power Supply 24
4 MAIN MECHANIC AND FLUIDIC PARTS 25
4.1 SINGLE PARTS 26
4.1.1 Sample/Horizontal and Vertical motors 26
4.1.2 Sampling needle 27
4.1.3 Needle washing head 27
4.1.4 Puffer reservoir 27
4.1.5 Dilutor block – HC30TS 28
4.1.6 Dilutor block – HC60TS 29
4.1.7 Measuring block (HC30TS) 30
4.1.8 Measuring block (HC60TS) 30
4.1.9 Pump 31

4.2 ASSEMBLED ANALYZER 31
4.2.1 Front Panel 31
4.2.2 Side Panel 32
4.2.3 Rear Panel (HC30TS) 32
4.2.4 Construction Front 33
4.2.5 Construction Side 33
5 OPERATION OF THE FLUIDIC SYSTEM 35
5.1 INITIALIZATION OF THE FLUIDIC SYSTEM 35
5.2 OPERATION OF THE FLUIDIC SYSTEM IN HUMACOUNT 30 TS 36
5.2.1 Flow diagram of measurement 36
5.2.2 Sampling process 38
5.2.3 Needle washing process 39
5.2.4 Diluting process 40
5.2.5 Lysing process 41
5.2.6 Counting process 42
5.2.7 Chamber draining process 43
5.2.8 Shutdown process 43
5.3 OPERATION OF THE FLUIDIC SYSTEM IN HC60TS 44
5.3.1 Sampling process 45
5.3.2 Diluting process 46
5.3.3 Lysing process 47
5.3.4 Counting process 48
5.3.5 Chamber draining process 49
5.3.6 Cleaning process 50
5.3.7 Shutdown process 50
6 ADJUSTMENTS 51
6.1 COMMON ADJUSTMENTS 51
6.1.1 Vertical movement, setting timing belt tension 51
6.1.2 Vertical opto sensor and needle settings 51
6.1.3 Setting the needle shaft 52
6.1.4 Setting the position of the chambers 53
6.2 HC30TS SPECIFIC ADJUSTMENTS 54
6.2.1 Setting the dilutor mechanics 54
6.2.2 Setting the horizontal movement 54
6.3 HC60TS SPECIFIC ADJUSTMENTS 55
6.3.1 Setting the dilutor mechanics 55
6.3.2 Setting the horizontal movement 55

CONTENTS
6.4 SERVICE CALIBRATION 56
6.5 SETTING RBC AMPLIFIER GAIN 57
6.6 SETTING WBC AMPLIFIER GAIN 58
7 CHECKIG THE PROPER OPERATION 59
7.1 SELF TEST 59
7.1.1 Self Test Screens 59
7.1.2 Normal range of Self Test parameters 60
7.1.3 Troubleshooting Guide for Self test 60
7.2 SERVICE MENU 61
7.2.1 Entering to Service Menu 61
7.2.2 Troubleshooting 62
7.2.3 Stress 63
7.2.4 Needle position check 64
7.2.5 Log in as SERVICE User 64
8 SERVICE OPERATION 67
8.1 POSSIBLE CAUSES OF NOISE 67
8.1.1 Contaminated reagent 67
8.1.2 Bad earth grounding 67
8.1.3 External electrical noise 68
8.1.4 Internal noise sources 68
9 MAINTENANCE 71
9.1 WEEKLY USER MAINTENANCE 71
9.1.1 Cleaning needle washing head 71
9.2 PERIODIC MAINTENANCE BY SERVICE 72
9.2.1 Check Self test and Device statistics 72
9.2.2 Cleaning and Greasing Dilutor Block 72
9.2.3 Checking and Lubricating Dilutor Piston Tips 72
9.2.4 Checking and Replacing Washing Head 73
9.2.5 Bleaching of Fluidic System 73
10 APPENDICES 75
10.1 WARNING FLAGS 75
10.2 USB B CONNECTOR COMMUNICATION 76
10.2.1 Characters and basic structure 77
10.2.2 Details of the 3.1 protocol 77

10.3 CABLING DIAGRAM 80
10.4 TUBING SCHEMATICS 82
10.5 RECOMMENDED KIT OF TOOLS 84

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
accurate 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 procedures. 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 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 char-
ge, 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
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 da-
mage so incurred shall be reported to the freight carrier for settlement or claim.
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.

HumaCount 30TS / 60TS | Service manual
6
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.
1.3 Intended Use of the Instrument
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
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.
HumaCount 30TS / HumaCount 60TS hematology analyzers are fully auto-
mated cell counters for in vitro diagnostic use. The compact instruments were
developed for small clinics, point-of-cares, and hospitals.
HumaCount 30TS can process 30, HumaCount 60TS can process 60 samples
per hour and they are intended to determine the following 18 hematology
parameters from a 25μL whole blood sample:
- WBC - LYM - MON - GRA - LYM% - MON% - GRA% (three-part WBC
differential)
- HGB - RBC - HCT - MCV - RDW - MCH - MCHC
- PLT - MPV - PCT – PDW
1.4 General Safety Warnings
Use only chemical reagents and accessories specified and supplied by HU-
MAN and/or mentioned in this manual. Place the product so that it has proper
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 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
instrument.
[IVD]
Este manual sirve para los siguientes modelos
1
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