BELIMED WD 290 Manuel utilisateur

Operating Instructions

WD 290

Item Number: 10532-0150-EN

Version: 001-07/09

2/49

001 Operating Instructions WD290

10532 © Belimed

Index of contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.1 Before you read on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.2 Target group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.3 Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.4 Symbols and notices used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2 For your safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.2 Care responsibilities for dealing with the device . . . . . . . . . . . . . . . . 5

2.3 Instruction of personnel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.4 Safety instructions on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.5 Fields of application for the device . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.6 Process validation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.1 Device loading side (LS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.2 Device unloading side (US) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.3 Operating unit on loading side (LS) . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.3.1 Description of operating unit on loading side . . . . . . . . . . . . . . . . . . 9

3.4 Operating unit on unloading side (US) . . . . . . . . . . . . . . . . . . . . . . 11

3.4.1 Description of operating unit on unloading side . . . . . . . . . . . . . . . 11

3.5 Process status display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.5.1 Process status display description . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.6 Procedure for changing settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.7 Alphanumeric entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.7.1 Procedure for alphanumeric entry. . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.7.2 Operating buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4 Pre-treatment of the medical devices . . . . . . . . . . . . . . . . . . . . . 16

4.1 Responsibility for pre-treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.1.1 SOP (Standard Operating Procedures) . . . . . . . . . . . . . . . . . . . . . 16

4.2 Preparation of the medical devices. . . . . . . . . . . . . . . . . . . . . . . . . 16

4.3 Pre-cleaning pre-treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.3.1 Impairment of subsequent cleaning . . . . . . . . . . . . . . . . . . . . . . . . 17

5 Preparation of the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

6 User log-on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

6.1 Log-on via operating unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

6.2 Log-on via barcode reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

7 Automatic start and switch-off, Self-disinfection . . . . . . . . . . . 23

7.1 Automatic switch-off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

7.1.1 Activating and setting the automatic switch-off function . . . . . . . . . 23

7.2 Automatic start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

7.2.1 Activating and setting the automatic start function . . . . . . . . . . . . . 24

7.3 Self-Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

7.3.1 Why self-disinfection? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

7.3.2 Activating and setting the self-disinfection function . . . . . . . . . . . . 25

Index of contents

Operating Instructions WD290 001

3/49

7.3.3 Starting self-disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

8 Loading and identifying racks . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

8.1 Loading racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

8.2 Rack identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

8.2.1 Rack identification via operating unit . . . . . . . . . . . . . . . . . . . . . . . 27

8.2.2 Rack identification via barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

9 Batch content identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

9.1 Batch identification via barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

10 Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

10.1 Manual loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

10.2 Automatic loading and unloading (optional) . . . . . . . . . . . . . . . . . . 31

11 Washing and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

11.1 General instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

11.2 Washing, disinfecting and drying . . . . . . . . . . . . . . . . . . . . . . . . . . 32

12 Unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

13 Switching off the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

14 Daily maintenance and cleaning tasks . . . . . . . . . . . . . . . . . . . . 37

14.1 Maintenance in general. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

14.2 Maintaining the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

14.3 Maintenance of the lower wash arm . . . . . . . . . . . . . . . . . . . . . . . . 38

14.4 Maintenance of the upper wash arm. . . . . . . . . . . . . . . . . . . . . . . . 39

14.5 Cleaning fine screens and coarse screen. . . . . . . . . . . . . . . . . . . . 40

15 Device does not clean properly. . . . . . . . . . . . . . . . . . . . . . . . . . 41

15.1 Checking the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

15.2 Checking the dosing system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

15.3 Checking rack loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

16 Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

16.1 Error display without process termination . . . . . . . . . . . . . . . . . . . . 42

16.2 Error display with process termination . . . . . . . . . . . . . . . . . . . . . . 43

16.3 Device will not operate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

17 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

17.1 Independent Process Data management IPD . . . . . . . . . . . . . . . . 44

17.2 Built-in printer US / LS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

17.2.1 Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

17.2.2 Replacing the paper roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

18 Conformity and certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

19 Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

20 Organisation Belimed AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

20.1 Manufacturer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

20.2 Subsidiaries, Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

21 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

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001 Operating Instructions WD290

10532 © Belimed

Introduction

1 Introduction

1.1 Before you read on

Your product meets high standards and is easy to operate. Nevertheless, please

take time to read these instructions carefully. You will become familiarised with

your product and be able to use it to its best.

1.2 Target group

These instructions are a component of the product and are intended for the fol-

lowing personnel:

They must be accessible for this group of persons!

1.3 Changes

The text, graphics and data correspond to the technical status of the product at

the time of going to print. Changes due to further development may occur.

Language original for this document is German (DE)

1.4 Symbols and notices used

The following symbols and occupational safety alerts used throughout the docu-

mentation are important to avoid harm to health and life.

Installation instructions Installer; Operating company; Technical support

Operating instructions Operator; Operating company; Technical support

Technical manual Operating company; Technical support

Danger

Indicates a hazard with high risk which, if not avoided, causes death or seri-

ous injury.

Warning

Indicates a hazard with medium risk which, if not avoided, can cause death or

serious injury.

Caution

Indicates a hazard with low risk which, if not avoided, can cause minor or

moderate injury.

Note

Operating tips and useful information on the best possible utilization.

For your safety

Operating Instructions WD290 001

5/49

2 For your safety

We affirm with the EC Declaration of Conformity and the CE mark that this prod-

uct complies with the basic health and safety requirements in accordance with

Directive 93/42/EEC Annex II (see Chap. 18 "Conformity and certifications").

Hazards may still arise from the product if it is used incorrectly by inadequately

trained personnel or not as intended.

2.1 Intended use

This product is exclusively approved for the uses stated in the instructions.

Namely for central sterilisation, substerilisation in surgery, in hospitals and in lab-

oratories. All other applications are considered as non-intended use.

2.2 Care responsibilities for dealing with the device

• Only use original racks, spare parts and accessories

•Load racks as intended (see Chap. 8 "Loading and identifying racks")

•Daily maintenance work on the device must be performed regularly and ac-

cording to instructions (see Chap. 14 "Daily maintenance and cleaning

tasks")

•Validation of the program parameters must be performed regularly (see

Chap. 2.6 "Process validation")

•Installation, deinstallation, maintenance or modification must only be

performed by persons authorised by Belimed

2.3 Instruction of personnel

This product must only be used, maintained and repaired by authorised, trained

and briefed personnel. This assumes that these instructions are read and under-

stood.

Responsibilities and competencies in operation, servicing and maintenance

must be clearly defined and observed.

2.4 Safety instructions on the device

Warning"Dangerous voltage"

Warning"Hot surface"

Warning"Caustic substances"

Follow safety instructions of the dosage media manufacturer!

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001 Operating Instructions WD290

10532 © Belimed

For your safety

2.5 Fields of application for the device

Cleaning and reconditioning of:

• Surgical instruments

• Minimally invasive instruments

• Instruments for anaesthesia and intensive care

• Baby bottles and teats

• Containers

• OT Shoes

• Laboratory instruments used in research and production

• Rigid endoscopes

• Eye instruments

• Neurosurgery

2.6 Process validation

The aim of process validation is to achieve a high level of safety in the recondi-

tioning of medical devices in order to afford the operators and patients the great-

est possible protection.

Process validation consists of:

a) Type testing / factory testing

b) Process validation consisting of:

• IQ (Installation Qualification)

• OQ (Operational Qualification)

• PQ (Performance Qualification)

c) Routine testing / Annual requalification

Warning

No single-use products may be reconditioned! Always adhere to the instruc-

tions of the medical device manufacturer!

Note

Further information on process validation may be obtained from Belimed

Customer Service.

Caution

Validation must only be carried out by authorised persons!

Devices must only be operated with processes validated in accordance with

regulations! Only use components (items to be washed, racks, programs and

dosage media) which have been validated together.

The safety of operators and patients may be compromised if the devices

used are not validated in accordance with the regulations.

Device description

Operating Instructions WD290 001

7/49

3 Device description

3.1 Device loading side (LS)

1 Process status display

2 Operating unit

3 Safety switch actuator

4 Washing chamber door

5 Emergency Stop

6 Lower front panel

7 Location of power rating plate

8 Transfer cart

9 Rack

Fig 496

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001 Operating Instructions WD290

10532 © Belimed

Device description

3.2 Device unloading side (US)

1 Process status display

2 Washing chamber door

3 Lower front panel

4 Emergency Stop

5 Operating unit

Fig 497

Device description

Operating Instructions WD290 001

9/49

3.3 Operating unit on loading side (LS)

3.3.1 Description of operating unit on loading side

Status bar

The status bar draws attention to certain settings and events by means of icons

and data. The status bar is device-dependent and in each case has the same

content on all screens.

Status bar icons

1) Menu button

2) Display

– Displays the

status bar, communication bar,

activity bar, selection options

3) Selection buttons

4) Confirmation button <OK>

5) On/Off button

6) Activity buttons

Fig 499

Symbol Description Symbol Description

Message inactive Warning active

Error active Doors locked

Doors open Doors closed

Door on loading side open Door on unloading side open

Automatic system active Automatic system inactive

Automatic system error

10/49

001 Operating Instructions WD290

Device description

Communication bar

The communication bar comprises an icon for the scroll wheel and a two-line text

display. The scroll wheel icon indicates, whether the operating unit is displaying

the "Home screen" or the "Information screen" .

Communication bar icons

Activity bar

The respective function options of the activity buttons are shown in the activity

bar. For screens with several pages, the respective page number and total num-

ber of pages is additionally displayed in the activity bar.

Activity bar icons

Symbol Description Symbol Description

Scroll wheel Home Scroll wheel Info

Symbol Description Symbol Description

Cursor forward Cursor back

Delete Delete all

Cursor up Cursor down

Capital letters Lower case letters

Numbers New

Page forward Page back

Open door Close door

Value minus (smaller) Value plus (larger)

Back

No user logged on New user

Program pause Program start

Deactivate door contact

pressure

Activate door contact pres-

sure

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