DiaCent-12 User Manual V 6.1 Feb 2007

Identification

Document DiaCent-12 User Manual Version : 6.1

Version

Date

Comment

Nb. : H 009121

1.0

First edition

2.0

Second edition

3.0

Third edition

4.0

11.03

Fourth edition

5.0

26.01.05

Fifth edition, adaptation of the new layout

6.0

19.08.05

Uniformization of contents

6.1

16.02.07

New document numbers WEEE compliance

Copyright © The reproduction, even partially, of this document is forbidden. No part may be copied in any form, and it may not be used, edited nor transmitted by any electronic means (photocopy, photography, magnetic supports or other recording processes), without the written authorization of DiaMed AG. All rights and particularly reproduction, translation, edition, distribution and also industrial property and recording are reserved. Printed in Switzerland

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Table of Contents

Table of Contents 1

Generalities ...6 1.1 Appropriate Use...6 1.2 Glossary ...7 1.2.1 Persons...7 1.2.2 Product ...8 1.3 Typographical conventions...8 1.3.1 Description...8 1.3.2 Command ...8 1.3.3 Procedure ...9 1.3.4 Cross reference ...9 1.3.5 List of items...9 1.3.6 Troubleshooting ...9 1.3.7 Warnings...10 1.3.8 Recommendation and Note ...11

2

Safety and handling...12 2.1 Introduction...12 2.1.1 Principle ...12 2.1.2 Importance of the safety instructions ...12 2.1.3 Non-compliance with the safety rules ...12 2.2 Environmental conditions ...13 2.3 General safety instructions ...14 2.3.1 Observations and informations ...15 2.4 Special safety instructions ...16 2.5 Storage conditions...16 2.5.1 Deactivation and storage ...16 2.5.2 Handling and transportation...17

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Description ...18 3.1 Principles of the process ...18 3.2 General description ...19 3.2.1 Design...19 3.3 System description ...20 3.3.1 Power connections, miniature fuse, and power switch ...20 3.3.2 Control panel ...20 3.3.3 Acoustic signals ...21 3.4 Features ...22 3.5 Technical data ...23 3.5.1 Performance data ...23 3.5.2 Transport data ...23 3.5.3 Physical data ...23 3.5.4 Dimensions and weight...24 3.5.5 Environmental conditions...24 3.5.6 Emissions ...24 3.6 Commercial information...25

4

Commissioning ...26 4.1 Unpacking and setting up the ID-Centrifuge...26 4.1.1 Installation site ...26 4.1.2 Unpacking...28 4.1.3 Connecting the ID-Centrifuge to the power network...29 4.1.4 Unpacking the centrifuge head ...29 4.2 Initial operation ...31 4.2.1 Configuring the general parameters ...31 4.3 Faults during the initial operation...39 4.3.1 Rectifying faults ...39 4.3.2 Keeping a maintenance record...39

5

Operation ...40 5.1 Operating procedures...41 5.1.1 Normal procedure ...41 5.2 Abnormal procedures ...45 5.2.1 Emergency stop...45 5.3 Turning off the centrifuge...45 5.3.1 Short interruption of operations ...45 5.3.2 Longer interruption of operations...46

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Maintenance ...47 6.1 Maintenance record...47 6.2 Maintenance plan ...48 6.3 Auxiliary materials ...49 6.3.1 Cleaning agents...49 6.3.2 Measuring devices...49 6.4 Cleaning ...50 6.4.1 Procedure ...51 6.5 Decontamination...52 6.6 Check and test of the instrument...53 6.6.1 Seal and lid ...53 6.6.2 Mobility of the sample tube holder ...53 6.6.3 Checking the target speed...55 6.6.4 Checking the centrifugation time ...57

7

Troubleshooting...60 7.1 List of possible problems ...61

8

Appendix...63 8.1 Graphical symbols ...63 8.1.1 Instrument-related symbols ...63 8.1.2 Package-related symbols ...63 8.2 Quality system ...64 8.2.1 Decontamination certificate ...64 8.2.2 Maintenance record ...66 8.2.3 Performance variation...68 8.3 N Conformity ...68

8.4 Spare parts ordering...68 8.5 Device disposal ...69 8.5.1 General warnings...69 8.5.2 Disposal ...69 8.6 List of documents ...70 8.6.1 User Manual ...70 8.6.2 Service Manual (english only)...70 8.7 Identification plate ...70

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Generalities 1

Chapter contents This chapter contains basic information on the structure of the document, its specifications and on the documentation. Preface This manual is dedicated to persons operating or carrying out any activities on the DiaMed AG DiaCent-12. It contains all the information necessary for safe operation and work with your ID-Centrifuge. The centrifuges are normally supplied with a User Manual available in several languages.



The Service Manual is available in English for the DiaCent-12 but only to authorized technical staff. See section “8.6 List of documents” on page 70 This manual is produced by DiaMed AG with the same care as the DiaCent-12. It is a fixed part of the IDCentrifuge. If you have any questions or are unclear about something, please contact your DiaMed AG agent immediately or contact us directly.

1.1

Appropriate Use The DiaCent-12 is used in modern human blood analysis technology. The DiaCent-12 is intended exclusively for the centrifugation of human blood samples in sample tubes. DiaMed AG’s DiaCent-12 may only be used by trained and authorised personnel in a medical laboratory. It may not be used in the patient’s direct environment. The centrifugation of materials other than those described in the User Manual is forbidden. Any other application is considered improper use of the centrifuge. The instructions contained in the present User Manual must be adherred to in particular the safety instructions.

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Generalities 1 1.2

Glossary The following terms, among others, are used in the present User Manual.

1.2.1

Persons Manufacturer The manufacturer of the DiaCent-12 is : DiaMed AG, CH-1785 Cressier sur Morat.

Operator The operator is the owner of an ID-Centrifuge, both when using it as its owner and when transferring it to a third-party.

Personnel The personnel gathers persons who have any kind of activity with the DiaCent-12 and who are qualified are in accordance with the manufacturer’s requirements and who are consequently authorised.

Technical personnel The term «technical personnel» designates the duly trained persons, who are allowed to perform specific tasks on the DiaCent-12. For instance, an electrician is designated as technical personnel for the activities linked to wiring the DiaCent-12 to the electrical network.

Personnel qualifications Several kinds of personnel qualifications are required in order to perform the activites related to the DiaCent-12. These qualifications are described in the corresponding sections of the present User Manual. The personnel qualifications define the minimal requirements which must be met by the authorised personnel.

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Generalities 1 Serious injury A serious injury is an injury (ICAO definition) which is sustained by a person in an accident and which : •

requires hospitalization for more than 48 hours, commencing within seven days from the date the injury was received;

•

results in a fracture of any bone (except simple fractures of fingers, toes, or nose);

•

involves lacerations which cause severe hemorrhage, nerve, muscle or tendon damage;

•

involves injury to any internal organ;

•

involves second or third degree burns, or any burns affecting more than 5 per cent of the body surface;

•

involves verified exposure to infectious substances or injurious radiation.

Light injury Any injury not corresponding to the definition of a serious injury is considered as a light injury.

1.2.2

Product This is the DiaCent-12 distributed by the manufacturer. ID-Centrifuge The term “ID-Centrifuge” is used for the DiaCent-12 for 100–240 VAC (Art.no. 840 000) made by DiaMed AG, CH - 1785 Cressier sur Morat, Switzerland.

1.3

Typographical conventions The following styles are used in this manual.

1.3.1

Description This style, use in conjunction with illustration numbers, is preceded with the corresponding numbers: Example:

(1)

First element

(2)

Second element

(3)

Etc...

1.3.2

Command Any software command, button, function key, window, icon, option, tab, checkbox, selection box, article, menu, tool bar, field and section used in this document is represented by a bold italic font. Example: The Exit command allows to quit the software.

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Generalities 1 1.3.3

Procedure Each procedure step to be carried out step-by-step by the user is preceded by a letter. Example:

A.

Open the drawer.

B.

Put the microplate into position as shown.

C.

Close the drawer.

1.3.3.1

Procedure result

A procedure result is shown by the following symbol . Example:

A.

1.3.4

Click on the Parameters button.

;The parameter window is displayed. Cross reference This style is used to help the user find complementary information linked to the current subject.

 1.3.5

Example: See section “4.2.4 Sensor Board Positioning” on page 37.

List of items This style is used in order to display a list of elements. Example:

1.3.6

•

item 1;

•

item 2;

•

item 3.

Troubleshooting The complete description along with the error message, the explanation and the remedy appears as follows:

Problem -

Explanation, possible cause 

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Generalities 1 1.3.7

Warnings In relation to the importance of the warning and its related risks, three warning styles are defined. The safety aspects are used in accordance with the requirements contained in the following norms :

1.3.7.1

•

ANSI Z535.4;

•

ISO 3864, ISO 3864-1:2002, and ISO 3864-2:2004.

Danger Used to designate an imminent and dangerous situation which, if not avoided, may lead to death or serious injury. The primary risk is given in capital letter below the specific risk does not exclude the presence of subsidiary risks.

symbol. However, mentioning a

Example:

ELECTROCUTION Never touch an exposed electrical wire. A contact with an electrical wire may cause an electrocution.

1.3.7.2

Warning Used to designate a potentially dangerous situation which, if not avoided, may lead to death or serious injury. Example:

Always disconnect the electrical cord before opening the instrument. A contact with an exposed electrical wire may cause an electrocution. 1.3.7.3

Caution Used to designate a potentially dangerous situation which, if not avoided, may lead to light injury or cause equipment damage. Example:

Do not manipulate a broken mirror with bare hands as this operation may result in cuts.

The use of the CAUTION sign without the warning triangle means that the only risk consists in equipment damage. Example:

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Generalities 1

The use of other cleaning agents or hard objects may damage the instrument. Do not use other cleaning agents or products without obtaining first the authorisation of the manufacturer.

1.3.8

Recommendation and Note When complementary information is required and if their non-compliance only leads to minor inconveniences, recommendations and notes are given.

1.3.8.1

Recommendation Used to designate a prefered procedure or a recommended practice. DiaMed AG denies any responsibility in case of non-compliance with the recommendations. Example:

< Recommendation: Check that the instrument is closed before switching it on. 1.3.8.2

Note Used to accompany a general remark or an purely informative comment.



Example: Note: The reassembly of the instrument is performed in the opposite order of its disassembling.

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Safety and handling 2

Chapter contents This chapter defines the safety instructions which guarantee a safe and troublefree operation of the DiaCent-12.

2.1

Introduction

2.1.1

Principle

The user must have read and understood this chapter before any operation on the DiaCent-12 instrument.

In case of unclear information, please contact the manufacturer or your DiaMed AG dealer.

2.1.2

Importance of the safety instructions Every safety and protection instruction which can be found in this manual must be adhered to in order to avoid personnel injuries, property damages or environnemental pollution. In a similar manner, the legal bylaws, the measures in prevention of accidents and for the protection of the environment, as well as the recognised technical rules aiming at appropriate and safe working conditions which as applied in the country and at the place of use of the DiaCent-12 instrument must be adherred to.

2.1.3

Non-compliance with the safety rules Disregarding the safety rules, as well as existing legal and technical regulations, may lead to accidents, property damages or to environnemental pollution.

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Safety and handling 2 2.2

Environmental conditions The DiaCent-12 must not be located near a water tap or any other source of water. This system may only be used in closed rooms and never in the immediate environment of patients. The electrical safety of the DiaCent-12 instrument is only guaranteed if the electrical installation is conform to the reglementation related to medical-use buildings and laboratories and if this installation works properly. The DiaCent-12 may not be used in buildings prone to explosion hazards.

The DiaCent-12 must be kept away from any interference source. The DiaCent-12 may not be stored under exposure to the direct sunlight, to heat, to dust or to an excessive humidity (only use the instrument in a clean laboratory environment).

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Safety and handling 2 2.3

General safety instructions

ELECTROCUTION During maintenance operations, when the DiaCent-12 is powered and its lidis removed, the instrument may not be left without watch.

INFECTION There is a risk of infection from skin contact with blood samples. Always wear protective gloves when working, in accordance with laboratory safety regulations.

The initial operation may only be carried out by engineers who, as a result of their training and experience, are familiar with the initial operation and the operation of laboratory instruments. Maintenance and repairs may only be performed in conformance with the instructions and by the technical personnel authorised by the manufacturer. The sole possession of the Service Manual does not allow the personnel to perform any kind of repair on the DiaCent-12. Take into account all the warnings and follow all the instructions displayed on the DiaCent-12 and which are printed in the documentation. It is mandatory to use the products specified in the present User Manual to clean the DiaCent12. If you plan to use another product, only do so after having obtained the authorisation of the manufacturer. Using materials other than those defined in the User Manual (unauthorised dangerous goods for instance) is forbidden. Breaching this rule will be considered by the manufacturer as guilty negligence. Never try to use replacement pieces other than those authorised by the manufacturer of the DiaCent-12. The centrifuge must not be operated with an open protective lid due to the risks of injury when the head is rotating.

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Safety and handling 2

The DiaCent-12 must be used on an appropriate table (See section “4.1 Unpacking and setting up the ID-Centrifuge” on page 26). Ensure that the ventilation around the DiaCent-12 is sufficient to avoid any excessive heating. A space of 300 mm all around the DiaCent-12 must be left clear of any obstacle. The DiaCent-12 must only be used with accessories approved by the manufacturer (example: ID centrifuge head). Do not operate the centrifuge in the case of damage or switch off immediately. Switch off the power switch and remove the power plug from the power supply! Mark the centrifuge as defective to prevent further use. The DiaCent-12 may not be used in combination with other machines. The manufacturer’s agreement must be obtained before using the DiaCent-12 in conjunction with other equipment.

Use the cleaners mentioned in the User Manual for cleaning the centrifuge. Other cleaners should be used only after consulting the manufacturer. Switch off the power switch and remove the power cord from the power supply when cleaning the centrifuge or when replacing the fuse. Repairs must be carried out by authorised personnel. Do not try to start up the centrifuge yourself (except when indicated by directions in the User Manual). Owning a Service Manual does not mean you are authorised to carry out repairs on the centrifuge. The manufacturer offers special training courses for repairing the DiaCent-12. You can obtain information from your DiaMed representative or manufacturer. This User Manual must always be accessible to all personnel working with the ID-Centrifuge. Never let any liquid enter the system. In case of liquid spill inside the instrument, act immediately as follows: A.

Switch off the instrument using the main switch.

B.

Unplug the power cord.

C.

Dry up the instrument.

D.

Clean and decontaminate the instrument.

E.

Check all its electrical functions.

2.3.1

Observations and informations

< Recommendation: For further information, please contact your DiaMed AG dealer or the manufacturer. In case of defective operation or any other technical incident for which no remedy is described in this manual, please contact immediately the manufacturer or your dealer. Safety measures ordered by the manufacturer are mandatory.

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Safety and handling 2 2.4

Special safety instructions Safety instructions are inserted at certain points in this manual to indicate special hazards which occur only in certain situations. They should be observed in the same way as the general safety instructions contained in this chapter.

2.5

Storage conditions

2.5.1

Deactivation and storage Deactivation is normally performed to transport the centrifuge to a different place inside or outside the laboratory, for repair in an internal or external workshop or for storage for later use.

To prevent danger to any persons during deactivation and during the inactive state, the centrifuge must be decontaminated before being transported to another place. A.

Decontaminate the centrifuge as described in section “6.5 Decontamination” on page 52.

B.

Fill in a decontamination certificate after decontamination. You can find a form for the decontamination certificate in the appendix at the end of this manual.

C.

Make a copy of the decontamination certificate and keep the original together with the centrifuge.

D.

Note the instructions in chapter “2.5.2 Handling and transportation” on page 17 before transporting the centrifuge.

2.5.1.1

Storage If the centrifuge is temporarily stored in a laboratory environment, complete packing is normally not required. However, if the centrifuge is stored in a storage room, basement or similar area for a longer period of time, we recommend that you pack it completely to protect it. Centrifuges must be packed for storage as described in chapter “2.5.2 Handling and transportation” on page 17.

< Recommendation: Use only the original packing to pack the centrifuge. For storage conditions, see chapter “3.5.5.2 Storage” on page 24.

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Safety and handling 2 2.5.2

Handling and transportation

2.5.2.1

Packing

< Recommendation: Use only the original packing for transport and shipping. Packing is required particularly when shipping or for the storage of the centrifuge.

A.

Before packing the centrifuge carry out a complete shut-down.

B.

Reconnect the centrifuge to the power network.

C.

Turn on the centrifuge and open the lid.

D.

Turn off the open centrifuge. Pull the power lead out of the appliance socket and out of the power supply socket.

E.

Place the packing and the centrifuge head in the tub of the centrifuge.

F.

Close the lid so that a click is heard.

G.

Place the centrifuge with its packing material into the transport box.

H.

Place all accessories in the box.

I.

Place all necessary papers in the box:

2.5.2.2

•

delivery note with complete information;

•

decontamination certificate.

Packing list The box should contain the following equipment:

2.5.2.3

•

1 ID-DiaCent 12

•

1 power cord (CH, EURO, or US)

•

1 User Manual

•

1 declaration of conformity

•

1 reception form

•

1 installation protocol

Transportation recommendation For domestic transportation, it is recommended to use : car, truck, postal parcel and train.



For international and overseas transportation, it is recommended to use a professionnal shipping company. Note: During transportation, make sure that all the instructions on the parcel are adherred to.

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Description 3

Chapter contents This chapter describes the design and function of individual modules of the DiaCent-12 including the operating and display panels as well as the basic principles of the process.

3.1

Principles of the process The centrifugation of blood samples is carried out in order to assist in the separation of the plasma or serum from the erythrocytes prior to carrying out certain analysis techniques. Direct and indirect antiglobulin tests (DAT, IAT) using the sample tube centrifugation technique also involve centrifugation phases following the addition of anti-human globulin (AHG). Compliance with the centrifugation parameters specified for the test is particularly important, in order to ensure sufficient sensitivity of the entire DAT or IAT process. Centrifugation which is too weak following the addition of AHG does not result in optimal agglutination, while centrifugation which is too strong produces a sediment which sticks firmly to the sample tube (clumps of erythrocytes). This means that excessive shaking is required in order to release this sediment from the bottom of the sample tube. Mechanical stress of this kind may result in the loss of weak or unstable agglutinates. The DiaCent-12 therefore offers the possibility of adjusting the centrifugation parameters in order to ensure optimal conditions for the separation of erythrocytes from serum or plasma and for antiglobulin tests using sample tube centrifugation or other immunohaematological processes which require a centrifugation phase during the test process.

3/4 Serum / Plasma

1/4 Erythrocytes Sample before centrifugation

Sample after centrifugation

Fig. 3-1: Sample before and after centrifugation

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Description 3 3.2

General description The following overview shows and names different modules and accessories from the centrifuge.

(1) (2)

(3) (4) (5)

(8) (6)

(7)

Fig. 3-2: Important modules

(1)

Lid

(2)

Driving axle

(3)

Tub

(4)

Housing

(5)

Operating panel

(6)

Centrifuge head 12 (standard)

(7)

Centrifuge head 6

(8)

Sample tubes

3.2.1

Design The centrifuge is designed with a plastic housing which is composed of two shells. The conical driving axle stands in the centre of the tub and this supports the removable centrifuge head. The tub is sealed tightly with a see-through lid which also has a protective function. The control panel is attached ergonomically to the chamfered front panel.

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Description 3 3.3

System description

3.3.1

Power connections, miniature fuse, and power switch The power supply connection, miniature fuse and power switch are combined and are built into the back wall of the centrifuge.

(1)

Power switch: power supply I = ON O = OFF

(2)

Miniature fuses

(3)

Appliance inlet

(4)

Power cord

(5)

Appliance plug

(6)

Power plug (Swiss, Euro or US version)

3.3.2

(3)

(4)

(5)

(6)

Fig. 3-3: Power socket, fuse and power switch

(1)

(2)

START / STOP / + button: Starts the centrifugation with the selected centrifugation program, or stops centrifugation which is in process. Depending on the operating mode, the button also alters the parameters or confirms the settings.

(2)

(2)

Control panel The control devices are all located on the control panel at the front. The control panel buttons are multi-function buttons, i.e. they are used to control the centrifuge directly, but they are also used for further functions or to input data, depending on the operating mode.

(1)

(1)

Fig. 3-4: DiaCent-12, operating panel

SPEED / TIME / – button: Used to select the centrifugation programs. Depending on the operating mode, the button alters the settings or the speed and the centrifugation time when the pre-selection programs are being configured. The active function of both multi-function buttons are described in detail, depending on the operating mode, in the corresponding descriptions of the relevant functions in See section “4 Commissioning” on page 26 and in See section “5 Operation” on page 40.

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