ID-Incubator 37 SI & 37 SII User Manual V 8.0 Oct 2010

Identification

Document ID-Incubator 37 SI & 37 SII User Manual Version : 8.0

Version

: H009119

Date

Comment

1.0

First edition

2.0

Second edition

3.0

Third edition

4.0

11.02

Fourth edition

5.0

11.03

Fifth edition

6.0

15.07.04

Sixth edition, adaptation of the new layout

7.0

22.08.05

Reordering of the chapters, minor editorial changes.

7.1

17.11.06

New document number

8.0

25.10.10

Brand Change

Manufacturer DiaMed GmbH 1785 Cressier FR Switzerland Tel.

+41 (0)26 67 45 111

Fax

+41 (0)26 67 45 145

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 Bio-Rad. All rights and particularly reproduction, translation, edition, distribution and also industrial property and recording are reserved. Printed in Switzerland

ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

Table of Contents

1

Generalities ...7 1.1 Appropriate Use ...7 1.2 Glossary ...8 1.2.1 Persons...8 1.2.2 Product ...9 1.3 Typographical conventions ...9 1.3.1 Description ...9 1.3.2 Command ...9 1.3.3 Procedure ...9 1.3.4 Cross reference ...10 1.3.5 List of items...10 1.3.6 Troubleshooting...10 1.3.7 Warnings...11 1.3.8 Recommendation and Note...12

2

Safety and handling ...13 2.1 Introduction ...13 2.1.1 Principle...13 2.1.2 Importance of the safety instructions...13 2.1.3 Non-compliance with the safety rules...13 2.2 Environmental conditions ...14 2.3 General safety instructions ...15 2.3.1 Observations and informations...17 2.4 Special safety instructions...17 2.5 Storage conditions ...18 2.5.1 Deactivation and storage ...18 2.5.2 Handling and transportation ...19

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Table of Contents 3

Description... 21 3.1 Principles of the process... 21 3.2 General description... 22 3.2.1 Housing and lid... 23 3.2.2 ID centrifuge head and ID-Card holder... 23 3.3 System description ... 25 3.3.1 Power socket, fuse and power switch ... 25 3.3.2 Operating panel... 26 3.3.3 Microprocessor ... 26 3.3.4 Acoustic signals ... 27 3.4 Features ... 27 3.5 Technical data... 27 3.5.1 Performance data... 27 3.5.2 Transport data ... 28 3.5.3 Physical data ... 28 3.5.4 Dimensions and weight ... 29 3.5.5 Environmental conditions... 29 3.5.6 Emissions ... 29 3.6 Commercial information... 30

4

Commissioning... 31 4.1 Unpacking and setting up the ID-Incubator ... 31 4.1.1 Installation site ... 31 4.1.2 Unpacking ... 33 4.1.3 Connecting the ID-Incubator to the power network ... 34 4.2 Initial operation... 35 4.2.1 Configuring the general parameters ... 35 4.3 Faults during the initial operation ... 38 4.3.1 Rectifying faults... 38 4.3.2 Keeping a maintenance record... 38

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ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

Table of Contents 5

Operation ...39 5.1 Operating procedure ...40 5.1.1 Normal procedures ...40 5.1.2 Loading the ID-Incubator ...44 5.1.3 Performing incubation ...46 5.2 Abnormal procedures...47 5.2.1 Emergency stop...47 5.3 Turning off the ID-Incubator...50

6

Maintenance...51 6.1 Maintenance record...51 6.2 Maintenance plan ...52 6.3 Auxiliary materials...53 6.3.1 Cleaning agents ...53 6.3.2 Measuring devices...53 6.4 Cleaning ...54 6.5 Decontamination ...56 6.6 Check and test of the instrument...57 6.6.1 Seal and cover ...57 6.6.2 Inspecting the fan filter...57 6.6.3 Checking incubation temperature...57 6.6.4 Checking incubation time ...58

7

Troubleshooting ...59 7.1 List of possible problems...60 7.2 Other operations...62 7.2.1 Checking the plug for the heating connection...62 7.2.2 Cleaning of the fan ...65

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Table of Contents 8

Appendix ... 67 8.1 Graphical symbols ... 67 8.1.1 Instrument-related symbols ... 67 8.1.2 Package-related symbols... 67 8.2 Quality system ... 68 8.2.1 Decontamination certificate ... 68 8.2.2 Maintenance record ... 70 8.2.3 Performance variation ... 72 8.3

 Conformity... 72

8.4 Device disposal... 72 8.4.1 General warnings ... 72 8.4.2 Disposal ... 72 8.5 List of documents ... 73 8.5.1 User Manual ... 73 8.5.2 Service Manual (english only) ... 73 8.6 Identification plate... 74

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ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

Generalities 1

Chapter Overview This chapter contains basic information on the structure of the document, its specifications and on the documentation.

Preface This manual is intended for all persons operating or carrying out any activities on the ID-Incubator 37 SI or 37 SII. It contains all the information necessary for safe operation and work with your ID-Incubator. The incubators are normally supplied with a User Manual available in several languages.



The Service Manual is available in english for the ID-Incubator 37 SI and 37 SII but only to authorized technical staff. See chapter “8.5 List of documents” on page 73

This manual is produced by DiaMed GmbH with the same care as the ID-Incubator 37 SI and 37 SII. It is a fixed part of the ID-Incubator. If you have any questions or are unclear about something, please contact your Bio-Rad agent immediately or contact us directly.

1.1

Appropriate Use The ID-Incubator 37 SI and 37 SII may be used only for incubation with ID-Cards. The ID-Incubator 37 SI and 37 SII 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 incubation of materials other than those described in the User Manual is forbidden (e.g. tubes with sample material). Any other application is considered improper use of the incubator. The instructions contained in the present User Manual must be adherred to in particular the safety instructions.

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1 Generalities 1.2

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

1.2.1

Persons Manufacturer The manufacturer of the ID-Incubator 37 SI and 37 SII is : DiaMed GmbH, CH-1785 Cressier sur Morat. Operator The operator is the owner of an ID-Incubator, 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 ID-Incubator 37 SI or 37 SII and who are qualified 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 ID-Incubator 37 SI or 37 SII. For instance, an electrician is designated as technical personnel for the activities linked to wiring the ID-Incubator 37 SI or 37 SII to the electrical network. Personnel qualifications Several kinds of personnel qualifications are required in order to perform the activites related to the ID-Incubator 37 SI or 37 SII. 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. 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.

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ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

Generalities 1 1.2.2

Product This is the ID-Incubator 37 SI or 37 SII distributed by the manufacturer. ID-Incubator The term “ID-Incubator” is used for the ID-Incubator 37 SI and 37 SII for 100–240 VAC made by DiaMed GmbH, CH - 1785 Cressier sur Morat, Switzerland. If information refers exclusively to a certain type of ID-Incubator, this is indicated in the text.

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.

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.

Click on the Parameters button.

The parameter window is displayed.

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1 Generalities 1.3.4

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 47. List of items This style is used in order to display a list of elements. Example: • item 1; • item 2; • item 3.

1.3.6

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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Remedy

ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

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: • ANSI Z535.4; • ISO 3864, ISO 3864-1:2002, and ISO 3864-2:2004.

1.3.7.1

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 letters below the DANGER symbol. However, mentioning a specific risk does not exclude the presence of subsidiary risks. 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.

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1 Generalities 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:

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. Bio-Rad denies any responsibility in case of non-compliance with the recommendations. Example:

Check that the instrument is closed before switching it on.

1.3.8.2

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

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

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ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

Safety and handling 2

Chapter Overview This chapter defines the safety instructions which guarantee a safe and troublefree operation of the ID-Incubator 37 SI and 37 SII.

2.1

Introduction

2.1.1

Principle

The user must have read and understood this chapter before he performs any intervention on the ID-Incubator 37 SI or 37 SII instrument.

In case of unclear information, please contact the manufacturer or your Bio-Rad 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 environmental 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 are applied in the country and at the place of use of the IDIncubator 37 SI or 37 SII 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 environmental pollution.

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2 Safety and handling 2.2

Environmental conditions The ID-Incubator 37 SI or 37 SII 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 ID-Incubator 37 SI or 37 SII 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 ID-Incubator 37 SI or 37 SII may not be used in buildings prone to explosion hazards.

The ID-Incubator 37 SI or 37 SII must be kept away from any interference source. The incubator may only be operated on a suitable work surface. The ID-Incubator 37 SI or 37 SII 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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ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

Safety and handling 2 2.3

General safety instructions

ELECTROCUTION During maintenance operations, when the ID-Incubator 37 SI or 37 SII is powered and its cover is 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.

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 ID-Incubator 37 SI or 37 SII. Take into account all the warnings and follow all the instructions displayed on the ID-Incubator 37 SI or 37 SII and which are printed in the documentation. The ID-Incubator 37 SI or 37 SII may only be connected to the electrical sources given in section “3.5.3 Physical data” on page 28. It is mandatory to use the products specified in the present User Manual to clean the IDIncubator 37 SI or 37 SII. 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’s manual (unauthorised dangerous goods for instance) is forbidden. Breaking 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 IDIncubator 37 SI or 37 SII.

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2 Safety and handling

The ID-Incubator 37 SI or 37 SII must be used on an appropriate table (See section “4.1 Unpacking and setting up the ID-Incubator” on page 31). Ensure that the ventilation around the ID-Incubator 37 SI or 37 SII is sufficient to avoid any excessive heating. A space of 100 mm all around the ID-Incubator 37 SI or 37 SII must be left clear of any obstacle. The ID-Incubator 37 SI or 37 SII must only be used with accessories approved by the manufacturer (example: ID-Card holder). Do not operate the incubators 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 incubator as defective to prevent further use. The ID-Incubator 37 SI and 37 SII may not be used in combination with other machines. The manufacturer’s agreement must be obtained before using the ID-Incubator 37 SI or 37 SII in conjunction with other equipment.

The incubators must not be operated with an open protective lid, as otherwise fluctuations in the temperature may occur which can affect test results. Use the cleaners mentioned in the user manual for cleaning the incubator. Other cleaners should be used only after consulting the manufacturer. The incubation of materials other than those described in the user manual is forbidden (e.g. tubes with sample material). Any disregard is considered gross negligence by the manufacturer. Switch off the power switch and remove the power cord from the power supply when cleaning the incubator or when replacing the fuse. Repairs must be carried out by authorised personnel. Do not try to start up the incubator yourself (except when indicated by directions in the user manual). Owning a maintenance manual does not mean you are authorised to carry out repairs on the incubator. The manufacturer offers special training courses for repairing the IDIncubator 37 SI and 37 SII. You can obtain information from your Bio-Rad representative or manufacturer. This User Manual must always be accessible to all personnel working with the ID-Incubators.

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ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

Safety and handling 2

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.

For further information, please contact your Bio-Rad dealer or the manufacturer.

2.3.1

Observations and informations 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.

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.

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2 Safety and handling 2.5

Storage conditions

2.5.1

Deactivation and storage Non-operation is normally performed to transport the incubator 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 non-operation the incubator must be decontaminated before being transported to another place.

A.

Decontaminate the incubator as described in section “6.5 Decontamination” on page 56.

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.

Keep the decontamination certificate together with the incubator after you have made a copy.

D.

Note the instructions in chapter “2.5.2 Handling and transportation” on page 19 before transporting the incubator.

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 transportation” on page 19.

for

storage

as

described

in

chapter

“2.5.2

Handling

and

Use only the original packing to pack the centrifuge.

For storage conditions, see chapter “3.5.5.2 Storage” on page 29.

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ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad

Safety and handling 2 2.5.2

Handling and transportation

Use only the original packing for transport and shipping.

2.5.2.1

Packing

Packing is required particularly when shipping or for the long-term storage of the incubator.

A.

Before packing the incubator carry out a complete shut-down including decontamination.

B.

Place the packing in the tub of the incubator (only for ID-Incubator 37 S II).

C.

Close the cover.

D.

Turn the incubator so that the right side is lying on the table.

E.

Place the packing part on the left side of the incubator.

F.

Turn the incubator 180° so that the left packing part is resting on the table.

G.

Place the packing part on the right side of the incubator.

H.

Place all accessories in the box.

I.

Place all necessary papers in the box: • delivery note with complete information; • decontamination certificate.

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2 Safety and handling 2.5.2.2

Packing list The box should contain the following equipment: • 1 ID-Incubator 37 S I (100 VAC to 240 VAC) or 37 S II (100 VAC to 240 VAC); • 1 power cord (Swiss, Euro, UK or US); • 1 user manual; • 1 declaration of conformity; • 1 reception form; • 1 installation protocol.

2.5.2.3

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.

During transportation, make sure that all the instructions on the parcel are adherred to.

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ID-Incubator 37 SI & 37 SII User Manual • © Bio-Rad