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HumaLyzer Primus | Service Manual

| Cat.No. 18200/200

REVISION HISTORY No. 1

Rev. / Date. 01/2010-07

Revision Description First edition

SYSTEM VERSION HumaLyzer Primus with software version 2.5e

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

1

2

Safety Instructions

5

1.1 1.2 1.3 1.4 1.5 1.6 1.7

5 5 6 6 7 7 8

User Warranty Intended Use of the Instrument General Safety Warnings Disposal Management Concept Biohazard Warning Instrument Disinfection Notice

System Description

10

2.1 2.2 2.3 2.4

10 10 10 11 11 11 12 13 14 14 15 16 16 17 19 20 21

Unpacking Product Features Product Structure and Composition Installation 2.4.1 Selecting a proper location for the instrument 2.4.2 Power supply requirement 2.4.3 Connecting the instrument to power supply 2.4.4 Installing the flow cell 2.5 Main Structure 2.5.1 Front view 2.5.2 Keypad 2.5.3 Back view 2.5.4 Internal Printer 2.5.5 Flow Cell and Cuvette 2.5.6 Lamp and peristaltic pump 2.5.7 Schematic System Diagram (for reference only) 2.6 Specifications

2

3

4

5

HumaLyzer Primus | Service manual

Functions

22

3.1 3.2 3.3

Function block diagram Functional description of the power supply Rear board functions 3.3.1 Functional description of the rear board 3.3.2 Function block diagram of the back board 3.3.3 Principle description of the rear board 3.4 Front board functions 3.4.1 Description of front board functions 3.4.2 Principle block diagram of front board 3.4.3 Controlling of choosing spectral filter 3.4.4 Control over liquid-intake intake of the peristaltic pump 3.4.5 Detection and controlling of temperature 3.4.6 Sampling and transformation of light energy 3.4.7 Control of the tungsten halogen lamp 3.5 Functional description of the pipeline 3.5.1 Functional Specifications 3.5.2 Structure of the pipeline 3.6 Functional description of the optical path 3.6.1 Functional Specifications 3.6.2 Structure of optical path

22 22 23 23 23 24 25 25 25 26 26 26 26 26 27 27 27 27 27 29

Replacement of modules

31

4.1 4.2 4.3 4.4 4.5 4.6

31 34 35 37 41 42

Disassembling of the analyzer Replacement of lamp Replacement of switch Replacement of spectral filter Replacement of signal receiving board Replacement of pipelines

Regular maintenance

44

5.1 5.2

44 44 44 44

Summary Cleaning the analyzer 5.2.1 Cleaning the surface of the analyzer 5.2.2 Cleaning the cell

3

5.2.3 5.2.4

6

Cleaning eaning the outside of the cell. Cleaning the inside of the cell

44 44

Problem-solving solving guide line

46

6.1 6.2 6.3 6.4

46 47 48 49

Fix pump tube Change the chip Optical setting instructions Change the input voltage between 110V and 220V

4

HumaLyzer Primus | Service manual

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1 SAFETY INSTRUCTIONS This manual is considered part of the instrument and must be available to the operator and the maintenance personnel. personnel For accurate installation, use and maintenance, please read the following instructions carefully. In order to avoid damage to the instrument or personal injury, injury carefully read the ”GENERAL SAFETY WARNINGS” describing the appropriate operating procedures. Please contact the local Technical Service in the event of instrument failure or other difficulties with the instrument.

1.1

User Warranty

HUMAN warrants that instruments sold by one of its authorised representatives 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, 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 pment 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.

1.2

Intended Use of the Instrument

The instrument must be used for its intended purpose (see paragraph 2). It must be operated in perfect technical conditions by qualified personnel in such working conditions and maintained as described in this manual in the GENERAL SAFETY WARNINGS. This manual contains instructions for qualified professional operators.

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1.3

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 ventilation. The instrument should be installed on a flat, f stationary working surface that is free of vibrations. Do not operate in area with excessive dust. Operate at temperature and at a humidity level in accordance with the specifications listed in this manual (chapter 7.1). Do not operate this instrument with covers and panels removed. Use only 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 The use of fuses instrument. uses with improper ratings may pose electrical and fire hazards. To avoid fire or shock hazard, observe all ratings and markings on the instrument. Do not power the instrument in environments that are potentially explosive or at risk of fire. Prior to cleaning clea and/or performing maintenance on the instrument, switch off the instrument and remove the power cord. Only nly cleaning materials described in this manual may be used, as other materials may damage parts. It is recommended to always wear protective apparell and eye protection while using this instrument. All warning arning symbols that appear in this manual must be carefully observed.

1.4

Disposal Management Concept

The applicable local regulations governing disposal must be observed. It is the user’s responsibility to arrange for the proper disposal of the individual components. All parts which may contain potentially infectious materials must be disinfected by suitable, suitable validated procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations regulat for disposal must be carefully observed. The instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to the regulations for the disposal of electronic components. Batteries, power packs and similar power po sources must be removed from electric/electronic parts and disposed of in accordance with applicable local regulations.

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1.5

Biohazard Warning

Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls which whic should be considered at least potentially infectious. Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious.

1.5 Biohazard 1.5-1: The „BIOHAZARD“ warning label must be affixed to instrument prior to first use with biological material !

1.6

Instrument Disinfection

Instruments or parts which may come in contact with biological samples (patient patient specimens, controls etc.) should be considered at least potentially infectious. Before performing any service work on the instrument, it is very important to thoroughly disinfect all possibly contaminated parts. Before the instrument is removed from m the laboratory for disposal or servicing, it must be decontaminated / disinfected. Decontamination/disinfection must be performed by authorised, well trained personnel and in observance of all necessary safety precautions. Instruments to be returned must be accompanied by a disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not supplied, the returning laboratory will be responsible for charges resulting from non-acceptance non of the instrument by the servicing centre or from intervention by governmental authorities.

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1.7

Notice

Every effort has been made to avoid errors in text and diagrams diagrams. HUMAN, however, assumes no responsibility for any errors which may appear in this publication. It is the policy of HUMAN to improve products as new techniques and components become available. HUMAN therefore reserve reserves the right to change specifications if necessary in the course of such improvements. Warning:

Warning indications must be obeyed in order to ensure the normal operation of instruments and correct and accurate test results. Boldface is used to indicate warnings.

Warning and Safety Indications This instrument is only used for in vitro diagnosis. Please carefully read the following warnings before usage and strictly obey them. Warning: Please carefully read the following instructions before using this instrument. Immediately turn off the power supply and pull the power plug from the outlet if there is an abnormal smell or smoke. You must then immediately consult the distributor for recommendations about appropriate tests tests. The instrument may cause fire, electric shock or personal injury if it is used continuously in such a condition. Neither blood, reagent nor metal pieces from staples or pins may be dropped into the instrument, as this may cause a short circuit, smoke or fire. In the event of abnormal malfunction, immediately turn off the power supply and pull the power ower plug from the outlet. You must then immediately consult the distributor for recommendations about appropriate tests. Operators may not touch the electric circuit inside the instrument, especially with wet hands (due to the increased risk of electric shock). Rubber gloves must be worn while performing maintenance and inspecting the instrument. The proper tools and spare parts must be used. After finishing the maintenance or inspection, please wash your hands using disinfectant liquid soap. Otherwise, skin skin which has come into contact with blood may be exposed to infection, electrical injury and burns.

HumaLyzer Primus | Service manual

9

Reagent application    

If the reagent contacts your eyes, flush your eyes immediately using large quantities of water and get medical help. If the reagent is accidently consumed (drunk), get medical help immediately and drink large quantities of water to induce vomiting. If your hand or skin is stained by the reagent, flush immediately with water. Tubes and other instruments must be properly disposed of as medical med waste or infectious waste after use. Contact with blood presents a risk of infection by pathogens.

Electrical voltage, connection and earthing 

 



Ensure that the plug is not inserted into an AC electrical outlet with voltage greater than 110/220 VAC AC ± 10%. 10 Otherwise, it may cause fire or electrical shock. The machine must be installed using the included three-pin three power cable. Ensure that it is well earthed. Otherwise, it may cause fire or electrical shock. Be sure not to damage the protective insulation on the power cable. Do not pull strongly on the power cable or hang heavy items off it. Otherwise, it may cause a broken circuit or a short circuit, which may cause electrical shock or fire. The power supply must be disconnected when connecting peripheral equipment. Otherwise, it may cause electrical shock or malfunctions. malfunctions Note:

To change the internal power supply of the instrument to be used with 110V AC power supply, please revert to the corresponding information in this Service Manual.

This change shall only be performed by a HUMAN GmbH trained service engineer.

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2 SYSTEM DESCRIPTION The product is intended for the in vitro diagnostic [IVD] clinical testing of serum, plasma, urine and CSF samples. The HumaLyzer H Primus is a semi-automated Chemistry Analyzer Analyzer.

2.1

Unpacking

Remove all the parts from their package. When unpacking the instrument, please make sure that the following items are contained in the packing. In case of damage or missing item, please cont contact the supplier immediately. HumaLyzer Primus Flow Cell User Manual Power Cord Spare Fuse Aspiration Tube Pump Tube Lamp Dust Cover Waste Bottle

2.2   

  

1 1 1 1 2 1 1 1 1 1

[REF]:18200 [REF]:18200/15 [REF]:18200/100 [REF]:18200/75 [REF]:18200/41 [REF]:18200/18 [REF]:18200/19 [REF]:18200/13 [REF]:18200/80 [REF]:18200/81

Product Features

Monochrome LCD, English menu (Spanish and Russian on request). Two test modes for single wavelength and double wavelength. The following test methods are available: End End-point Fixed Fixed-time Kinetic Bichromatic Absorbance Multi Multi-point calibration It can perform sample analysis of serum, plasma, whole blood and urine. Compatible with reagents without any specific restrictions. Internal printer can print reports and programming programming parameters, etc.

2.3

Product Structure and Composition

The product is composed of an optical system, a sipper system, a computer control system and software. software

HumaLyzer Primus | Service manual

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2.4

Installation

2.4.1 SELECTING A PROPER LOCATION FOR FO THE INSTRUMENT Find a place that is not exposed to direct sunshine. The surface of the selected installation location should be flat and provide sufficient space to accommodate the HumaLyzer Primus. The front edge of the instrument should be near the edge of the working table. Avoid significant vibrations on the working table (for example, do not place a centrifuge on the working table).

Note:

The temperature of the instrument’s operating environment must be between 10…30°C with a relative humidity below 70%.

In order to ensure proper functioning of the instrument, it may not be placed in the following areas:  Areas subject to extreme temperature changes  Very hot or cold areas  Very dusty areas  Areas near electromagnetic devices that produce a magnetic field  Areas exposed d to direct sunshine

2.4.2 POWER SUPPLY REQUIREMENT MENT  110/220Vac ±10%  50/60±1 Hz  80VA

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2.4.3 CONNECTING THE INSTRUMENT UMENT TO POWER SUPPL SUPPLY 1. Insert one end of the power cable into the instrument’s power plug. 2. Insert the other end of the power cable into the power supply’s out outlet. Warning: AC power must be well earthed (near-ground voltage