B2 Operators Manual WD290-09.pdf

Operating Instructions

WD 290

Item Number: 10532-0150-EN

Version: 001-07/09

2/49 001 Operating Instructions WD290

10532 © Belimed

Index of contents

Index of contents

1 Introduction

1.1 Before you read on

1.2 Target group

1.3 Changes

1.4 Symbols and notices used

2 For your safety

2.1 Intended use

2.2 Care responsibilities for dealing with the device

2.3 Instruction of personnel

2.4 Safety instructions on the device

2.5 Fields of application for the device

2.6 Process validation

3 Device description

3.1 Device loading side (LS)

3.2 Device unloading side (US)

3.3 Operating unit on loading side (LS)

3.3.1 Description of operating unit on loading side

3.4 Operating unit on unloading side (US)

3.4.1 Description of operating unit on unloading side

3.5 Process status display

3.5.1 Process status display description

3.6 Procedure for changing settings

3.7 Alphanumeric entry

3.7.1 Procedure for alphanumeric entry

3.7.2 Operating buttons

4 Pre-treatment of the medical devices

4.1 Responsibility for pre-treatment

4.1.1 SOP (Standard Operating Procedures)

4.2 Preparation of the medical devices

4.3 Pre-cleaning pre-treatment

4.3.1 Impairment of subsequent cleaning

5 Preparation of the device

6 User log-on

6.1 Log-on via operating unit

6.2 Log-on via barcode reader

7 Automatic start and switch-off, Self-disinfection

7.1 Automatic switch-off

7.1.1 Activating and setting the automatic switch-off function

7.2 Automatic start

7.2.1 Activating and setting the automatic start function

7.3 Self-Disinfection

7.3.1 Why self-disinfection?

7.3.2 Activating and setting the self-disinfection function

Index of contents

Operating Instructions WD290 001 3/49 © Belimed 10532

7.3.3 Starting self-disinfection

8 Loading and identifying racks

8.1 Loading racks

8.2 Rack identification

8.2.1 Rack identification via operating unit

8.2.2 Rack identification via barcode

9 Batch content identification

9.1 Batch identification via barcode

10 Loading

10.1 Manual loading

10.2 Automatic loading and unloading (optional)

11 Washing and disinfection

11.1 General instructions

11.2 Washing, disinfecting and drying

12 Unloading

13 Switching off the device

14 Daily maintenance and cleaning tasks

14.1 Maintenance in general

14.2 Maintaining the device

14.3 Maintenance of the lower wash arm

14.4 Maintenance of the upper wash arm

14.5 Cleaning fine screens and coarse screen

15 Device does not clean properly

15.1 Checking the device

15.2 Checking the dosing system

15.3 Checking rack loading

16 Errors

16.1 Error display without process termination

16.2 Error display with process termination

16.3 Device will not operate

17 Options

17.1 Independent Process Data management IPD

17.2 Built-in printer US / LS

17.2.1 Function

17.2.2 Replacing the paper roll

18 Conformity and certifications

19 Glossary

20 Organisation Belimed AG

20.1 Manufacturer

20.2 Subsidiaries, Customer Service

21 Notes

4/49 001 Operating Instructions WD290

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 © Belimed 10532

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!

6/49 001 Operating Instructions WD290

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 © Belimed 10532

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

8/49 001 Operating Instructions WD290

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

Operating Instructions WD290 001 9/49 © Belimed 10532

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

Operating Instructions WD290 001 11/49 © Belimed 10532

3.4 Operating unit on unloading side (US)

3.4.1 Description of operating unit on unloading side

Status bar

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

Status bar icons

1) LED Displays

– a) LED Red flashes - Warning active;

LED Red lights permanently - error ac-tive

– b) LED Green lights permanently -

Program cycle active

– c)LED Green lights permanently -

Doors locked

2) Display

– Displays the

Status bar, activity bar

3) Activity button

Fig 500 a b c

Symbol Description Symbol Description

Automatic system active Automatic system inactive

Doors locked

Doors open Doors closed

Door on loading side open Door on unloading side open

12/49 001 Operating Instructions WD290

Device description

Activity bar

The respective function option of the activity button is shown in the activity bar.

The options available depend on the respective machine status of the device.

Activity bar icons

3.5 Process status display

3.5.1 Process status display description

Process status display

The process status display is located above the washing chamber door on the loading side and the unloading side. The process status display shows the cur-rent operating status of the device.

Symbol Description When displayed

Open door Program completed correctly, door ready to open

Close door Door ready to close

Brightness and background illumination setting

User setting, display settings for unloading side

Contrast setting User setting, display settings for unloading side

Confirmation of display set-tings

User setting, display settings for unloading side

• Display starting position

– All LEDs = Dark (no display)

• Program in Progress-Display

– see description

• Error display

– All LEDs = Red, flashing

• Process interruption display

– All LEDs = Red, flashing

* = 1. LED

Fig 576

Operating Instructions WD290 001 13/49 © Belimed 10532

Display while program is in progress:

• If the remaining run time is more than 55 min, a running light which rotates clockwise is displayed.

• If the remaining run time is between 50 and 55 min, the first LED lights up.

Every 5 min, a further LED lights up.

• At the end of the program, all 12 LEDs flash.

• The LEDs are turned off when the door is opened or in the event of an error.

3.6 Procedure for changing settings

Example - Setting the date:

� Select date display

The current cursor position is lighted up

� Select value to be modified using the activity button

� Increase value using activity button , or decrease with

� After setting all values, confirm settings with <OK> -Button

O Settings

Operating language

German �

Date

09.02.2009 �

Weekday

Monday �

Time

07:15 �

� O � � �

14/49 001 Operating Instructions WD290

Device description

3.7 Alphanumeric entry

The alphanumeric entry screen consists of three separate screens.

1st screen = Capital letters

2nd screen = Lower case letters

3rd screen = Numbers

To change screens, press activity button > > .

Example - Capital letters:

3.7.1 Procedure for alphanumeric entry

If a text is to be edited, or if entry of a user password is required, the screen switches to alphanumeric entry, and the text to be edited is copied into the line.

The cursor is positioned after the last character.

The initial screen is always the entry screen with capital letters. The line is de-fined according to the screen that was selected before.

Only one character is edited at a time. The cursor position is indicated by the background of the character flashing, the background alternating between white and light green.

By pressing the <OK> -Button, the edited text is saved and the display reverts to the original screen.

3.7.2 Operating buttons

Selection buttons

The characters of the respective line can be selected using the selection buttons.

Pressing for the first time selects the first character of the line. Pressing again causes the cursor to jump to the next character on the right. After the last char-acter, the cursor returns to the first character again.

O

XXX

XXX

A B C D E F G �

H I J K L M N �

O P Q R S T U �

V W X Y Z _ - �

S a m p l e t e x t

Operating Instructions WD290 001 15/49 © Belimed 10532

Confirmation button

Activity buttons

Icon:

Icon description: Confirmation button

Function when acti-vated:

Display reverts to original screen; the edited text is saved

Icon:

Icon description: Back

Function when acti-vated:

Display reverts to original screen; the edited text is not saved

Icon: > > > > > >

Icon description: Capital letters Lower case let-ters

Numbers

Function when acti-vated:

Screen switches to capital letters

Screen switches to lower case letters

Screen switches to numbers

Icon:

Icon description: Delete

Function when acti-vated:

Deletes character at cursor position; cursor stays at this position

Special function: For password entry (depending on activated option), it is possible to log on the user under "No Identifica-tion"; Display <NIdent>; when a character is entered, the function switches to "Delete" -activity

Icon:

Icon description: Cursor forward

Function when acti-vated:

Cursor moves forward one position

OK

16/49 001 Operating Instructions WD290

Pre-treatment of the medical devices

4 Pre-treatment of the medical devices

4.1 Responsibility for pre-treatment

The operating company is responsible for pre-treatment of medical devices. The best possible washing results are only to be achieved with correct pre-treatment according to instructions.

4.1.1 SOP (Standard Operating Procedures)

The contents of the following criteria and specifications must be defined:

• Product responsibility

• Transport routes and disposal time (time for soiling to dry in)

• Type of soiling (blood, ointments, bone meal...)

• Material properties and compatibility of the items to be washed (risk groups acc. to RKI Ordinance)

• Consideration of all operating instructions and reconditioning regulations for medical devices

• Necessary knowledge of the medical devices to be reconditioned

• Maintenance plan and regular inspections

Belimed recommends producing work instructions which describe the procedure within a working process.

4.2 Preparation of the medical devices

All inner and outer surfaces must be accessible for cleaning (open valves, taps, articulated instruments...). Special attention should be given to the lumina. Dis-assemble MIS or other complex instruments according to the manufacturer's specifications.

Caution Always observe the manufacturer's specifications for the medical device to be treated!

Caution Not all medical devices are suitable for mechanical reconditioning (see Chap.

2.5 "Fields of application for the device")

Pre-treatment of the medical devices

Operating Instructions WD290 001 17/49 © Belimed 10532

4.3 Pre-cleaning pre-treatment

Remove coarse soiling immediately after use. Dried-on blood or tissue reduces the effectiveness of cleaning.

4.3.1 Impairment of subsequent cleaning

Various treatments fix proteins and may contribute to preserving prion infectiosi-ty.

The following pre-treatment methods may cause impairments in subsequent washing:

• Pouring antiseptic solutions on the items to be rinsed

• Pre-treatment with aldehydic disinfectants

• Pre-treatment with alcohol solutions

• Aldehyde and alcohol vapours

Note We recommend cold rinsing of the pre-treated washing utensils prior to mechanical cleaning and disinfection.

Caution Excessive foam can prevent pressure building up in the cleaning system and therefore impair optimal contact between the cleaning agent and the items to be washed.

18/49 001 Operating Instructions WD290

Preparation of the device

5 Preparation of the device

� Open utility supply

� Check the quantity of dosage media (see Chap. 16 "Errors")

� Switch the device on with button (see Chap 3.3 "Operating unit on loading side (LS)"). The start screen appears on the operating unit

Table 1: Start screen

� Press the menu button (see Fig. 686). The menu screen is displayed

1 Menu

2 Menu button

3 Operating mode

Warning Only operate the device if it is in a technically faultless condition! Damaged or defective components must immediately be reported to technical support.

After a prolonged period without using the device (approx. 1 week), the device must be prepared in accordance with the specifications for daily main-tenance work (see Chap. 14 "Daily maintenance and cleaning tasks").

Program

P01

Program Name �

P02

Program Name �

P03

Program Name �

P04

Program Name �

� O � � O

I

Fig 686

Preparation of the device

Operating Instructions WD290 001 19/49 © Belimed 10532

Table 2: Menu screen

Menu displays:

• Log on

(see Chap. 6 "User log-on")

• Automatic start / Autom. switch-off / Self-disinfection

(see Chap. 7 "Automatic start and switch-off, Self-disinfection")

• Machine information e.g. machine type, machine name, machine number, ...

• Messages, Errors

Messages: Rectify error (see Chap. 16 "Errors")

Alerts: Notify technical support

• Settings e.g. operating language, date, time, ...

• Cleaning the screen

• User Management

• Measurements

Menu

Log on �

Automatic start / Autom. switch-off

/ Self-disinfection

Machine information �

Messages, Errors �

O O � � O

Menu

Settings �

Cleaning the screen �

User Management �

Measurements �

O O � � O

20/49 001 Operating Instructions WD290

User log-on

6 User log-on

The user must log on each time before using the device. The log-on data are for-warded to the printer or the digital documentation system and assigned to the re-spective batch.

Log-on data are entered via the operating unit or via barcode reader.

6.1 Log-on via operating unit

After switching on the device, a program can be selected.

� Select program. The background of the selected program is displayed in a light shade

� Confirm selection by pressing <OK> -Button. User log-on appears

� Select list. The display for user password entry appears

� Enter user password via operating unit

Display:

Program

P01

Program Name �

P02

Program Name �

P03

Program Name �

P04

Program Name �

� O � � O

O Log on

User 01 �

User 02 �

User 03 �

User 04 �

� O � � O

O User password

User log-on

Operating Instructions WD290 001 21/49 © Belimed 10532

Example 1:

� Confirm entry by pressing <OK> -Button. The notification display for the log-on appears or

� Device is ready for starting the program

Note The length of the password input is limited to 20 characters. The activity but-ton can only be pressed if no character has been entered yet.

For entry by the operating unit we recommend a list of numbers with the cor-responding names (see Example 1).

No. Name

1 M. Smith

2 H. Jones

3 A. Baker etc

O Note

O User

User 01 O

Logged on

Level: X O

O

O O O O �

O Note

O

Wrong password O

O

O

� O O O O

Note The user can be logged on directly via password. The system finds the user by matching the password.

22/49 001 Operating Instructions WD290

User log-on

6.2 Log-on via barcode reader

After switching on the device, a program can be selected

� Select program. The background of the selected program is displayed in a light shade

� Confirm selection by pressing <OK> -Button. User log-on appears

� Read in the barcode via the barcode reader

� Confirm entry by pressing <OK> -Button. The notification display for the log-on appears (see Chap. 6.1 "Log-on via operating unit")

Sample barcode:

� Device is ready for starting the program

Program

P01

Program Name �

P02

Program Name �

P03

Program Name �

P04

Program Name �

� O � � O

O Log on

User 01 �

User 02 �

User 03 �

User 04 �

� O � � O

Note The length of the identification input is limited to 20 characters.

Barcodes for name labels can be produced from the Internet by the user him-self (free of charge). (http://www.barcodemagic.com/barcodemagic.html).

First name / last name

Patrick Schwarz

Fig 571

Automatic start and switch-off, Self-disinfection

Operating Instructions WD290 001 23/49 © Belimed 10532

7 Automatic start and switch-off, Self-disinfection

The display is selected via the menu screen (see Table 2 in Chap. 5 "Preparation of the device").

7.1 Automatic switch-off

In an automatic start, a washing program can be started automatically at a time which can be freely selected. After completing the program, the device switches automatically to "Stand by" -Mode. In this mode, the device does not continue to keep the DI tank at the specified temperature.

7.1.1 Activating and setting the automatic switch-off function

� Select "Automatic switch-off" -Function

� Select function and enter value for setting via operating unit

� After entering settings, confirm values by pressing <OK> -Button

O Automatic start / switch-off / SD

Automatic switch-off �

Automatic start �

Self-Disinfection �

O

� O O O O

O Automatic function:

Selection On / Off

Time:

Time for automatic switch-off can be freely selected.

Automatic switch-off

Automatic function

On �

Time

19.00 �

O

O

� O O O �

24/49 001 Operating Instructions WD290

Automatic start and switch-off, Self-disinfection

7.2 Automatic start

In an automatic start, a washing program can be started automatically at a time which can be freely selected.

7.2.1 Activating and setting the automatic start function

� Select "Automatic start" -Function

� Select function and enter value for setting via operating unit

� After entering settings, confirm values by pressing <OK> -Button

O Automatic function:

Selection On / Off

Time:

Time for automatic start can be freely selected.

Weekday:

Weekday selection. Options see note below

Program number:

Selection of an existing program

Automatic start

Automatic function

On �

Time

5:00 �

Weekday

Monday-Friday �

Program number

02 �

� O O O �

Note Selection of weekly programs: Monday-Friday; Monday-Saturday; Monday-

Sunday; Sunday-Friday; Saturday-Thursday

Automatic start and switch-off, Self-disinfection

Operating Instructions WD290 001 25/49 © Belimed 10532

7.3 Self-Disinfection

7.3.1 Why self-disinfection?

Microorganisms form in the washing chamber, tubing and PW tank after a pro-longed period not using the device. Following a thermal disinfection step, resi-dues of dead germs on the medical device may constitute a risk for patients.

If self-disinfection is active, the user is requested to perform self-disinfection af-ter a programmed period (24 hours as standard) following the last program run.

7.3.2 Activating and setting the self-disinfection function

� Select "Self-disinfection" -Function.

� Selection of function and enter value for setting via operating unit

� After entering settings, confirm values by pressing <OK> -Button

Caution Never carry out self-disinfection without a rack!

Always carry out self-disinfection with empty rack!

Note When the power supply is interrupted (main switch "Off"), the timer is inac-tive. For this reason, the request "Start self-disinfection" always appears when the device is switched on and self-disinfection is active.

Always carry out self-disinfection with empty rack!

O Operation:

Selection On / Off

Waiting time:

Waiting time can be freely selected. 1-99 h.

Self-disinfection

Operation

On �

Waiting time

24 �

O

� O O O �

26/49 001 Operating Instructions WD290

Automatic start and switch-off, Self-disinfection

7.3.3 Starting self-disinfection

� Open washing chamber door with activity button

� Insert empty rack

� Close washing chamber door with activity button .

� User identification (see Chap. 6 "User log-on")

� Start self-disinfection in the "Self-disinfection" sub-menu

This is always the last of the programs available

Procedure in case of error:

� If an error occurs during operation, resolve the error and confirm error reso-lution.

� Select "Confirm error resolution" -Function

� If the error persists -->see Chap. 16 "Errors"!

� If the error cannot be rectified, technical support must be informed

� End of program is displayed and additionally indicated by flashing process status display

Caution Do not wash any items with the self-disinfection program! No cold pre-rinse is carried out. There is a risk of excessive foam formation and fixing proteins.

O Process error Program Name

Error xxx O xxxxxxx

Step x.x:

Date:

Time:

xxxxx xx.xx.xxxx xx:xx

O

Program intervention �

Confirm resolution �

O O O O O

Danger If smoke is emitted or water escapes, immediately press Emergency Stop and disconnect the device from the building power supply. Call technical sup-port to have system repaired.

Note For manual loading and unloading, unload the rack in reverse from the LS after the program has ended. The US washing chamber door remains locked.

For automatic loading and unloading, the self-disinfection function is inactive.

Loading and identifying racks

Operating Instructions WD290 001 27/49 © Belimed 10532

8 Loading and identifying racks

8.1 Loading racks

The loading of racks has a significant influence on the washing outcome. For correct and intended loading it is absolutely necessary to follow the in-structions supplied with the rack.

8.2 Rack identification

The rack identification is forwarded to the printer or the digital documentation sys-tem and assigned to the relevant batch.

Identification is entered via the operating unit or via barcode reader.

8.2.1 Rack identification via operating unit

Display:

� Enter the identification number via the operating unit.

� Confirm entry by pressing <OK> -Button

8.2.2 Rack identification via barcode

Display:

� Read in the barcode via the barcode reader

� Confirm entry by pressing <OK> -Button

Danger Always wear protective goggles and gloves when handling the items to be washed. Soiled items to be washed may cause infections!

O Rack identification

XXX

Note The length of the identification input is limited to 20 characters. The activity button can only be pressed if no character has been entered yet.

O Rack identification

XXX

Note The length of the identification input is limited to 20 characters (see Chap. 6.2

"Log-on via barcode reader").

Barcodes can be produced from the Internet by the user himself (free of charge). (http://www.barcodemagic.com/barcodemagic.html).

28/49 001 Operating Instructions WD290

Batch content identification

9 Batch content identification

The identification of batch content is forwarded to the printer or the digital docu-mentation system and assigned to the relevant batch.

Detection takes place via the operating panel or by means of barcode reader.

9.1 Batch identification via barcode

Display:

� Read in the barcode via the barcode reader

� Confirm entry by pressing <OK> -Button

Example:

O Batch identification

XXX

Note The length of the identification input is limited to 20 characters (see Chap. 6.2

"Log-on via barcode reader").

Barcodes can be produced from the Internet by the user himself (free of charge). (http://www.barcodemagic.com/barcodemagic.html).

Reading-in is terminated automatically after reaching a max. of 18 batch con-tents.

Fig 227

Loading

Operating Instructions WD290 001 29/49 © Belimed 10532

10 Loading

10.1 Manual loading

� Latch transfer cart with loaded rack onto the device (Fig. 578 Pos.1)

1 Attachment and detachment hook

2 Transfer cart

3 Unlocking lever

4 Rack

� Open washing chamber door with activity button .

� Insert the loaded rack into the washing chamber (Fig. 578)

- Rack docking site must coincide with device docking site

- Rack must snap into place on the retainer (Fig. 579)

Danger Always wear protective goggles and gloves when loading. Soiled items to be washed may cause infections!

Fig 578

Caution Sharp or pointed objects may fall down when inserting the rack. This can cause injuries.

Wash arms must not be blocked by objects that are too high, or that protrude below the rack. Check rotation by hand!

30/49 001 Operating Instructions WD290

Loading

1 Rack

2 Retainer

� Close washing chamber door with activity button

� Device is ready to start

Display:

Fig 579

Program

P01

Program Name �

P02

Program Name �

P03

Program Name �

P04

Program Name �

� O � � O

Note Check to ensure that date and time are correct. These data are important for batch documentation. Report inconsistencies to technical support immedi-ately!

Loading

Operating Instructions WD290 001 31/49 © Belimed 10532

10.2 Automatic loading and unloading (optional)

For correct operation and maintenance in accordance with specifications, it is ab-solutely necessary to follow the operating instructions for the automatic loading and unloading module included in delivery.

1 Rack

2 Emergency Stop

3 Operating buttons

4 Rollers with automatic drive

5 Automatic loading and unloading module

Fig 582

32/49 001 Operating Instructions WD290

Washing and disinfection

11 Washing and disinfection

11.1 General instructions

Emergency Stop Function

Emergency Stops are located on the loading and on the unloading side. Activat-ing the Emergency Stop immediately stops and terminates a running process.

If a problem occurs during a process, the following steps must be taken:

� Press Emergency Stop

The current process is stopped and terminated

� Rectify error (see Chap. 16 "Errors")

� Restart program

11.2 Washing, disinfecting and drying

� Select required program

� Confirm program selection by pressing <OK> -Button

Program cycle starts

These steps proceed automatically for automated program recognition (option-al).

Warning Only operate the device with the original device panelling! Uncontrolled escape of water due to breakage of pipes or ruptured tubes can cause scald-ing. Only remove the device panelling once the device is disconnected from the mains supply.

Program

P01

Program Name �

P02

Program Name �

P03

Program Name �

P04

Program Name �

� O � � O

Note For "Automatic program recognition", the items to be washed must be checked whether they fit the program name!

Washing and disinfection

Operating Instructions WD290 001 33/49 © Belimed 10532

Display while program is in progress:

Procedure in case of error:

� If an error occurs during operation, resolve the error and confirm error reso-lution

� Select "Confirm error resolution" -Function

� If the error persists -->see Chap. 16 "Errors"!

� If the error cannot be rectified, technical support must be informed

� End of program is displayed and additionally indicated by flashing process status display

Program PXX in progress

Program Name

Remaining Run Time: 9.5 min O Step: 1.1 Dry

Actual: Target:

Time: 3.1 15 min O Temp.: 52 35 °C

A0 Value: 0

Batch information �

Terminate program �

O O O O O

O Process error Program Name

Error xxx O xxxxxxx

Step x.x:

Date:

Time:

xxxxx xx.xx.xxxx xx:xx

O

Program intervention �

Confirm resolution �

O O O O O

Danger If smoke is emitted or water escapes, immediately press Emergency Stop and disconnect the device from the building power supply. Call technical sup-port to have system repaired.

34/49 001 Operating Instructions WD290

Washing and disinfection

Display for end of program on LS:

O Program finished

O

Program PXX

Program Name O

Correctly Finished

O

O O O O O

Unloading

Operating Instructions WD290 001 35/49 © Belimed 10532

12 Unloading

Display for end of program on US:

� Attach the transfer cart to the device

� Open washing chamber door on US with activity button

� Withdraw washed items (Fig. 581)

1 Rack

2 Transfer cart

3 Interlock

4 Attachment and detachment hook

5 Operating unit

� Close washing chamber door on US with activity button

� Device is ready for reloading from loading side

� Visually inspect cleaning result. If washed items are still contaminated, re-peat washing with the same program!

� Detach the transfer cart using the interlock (Fig. 581 Pos. 3)

� Washed items are ready for further processing

Correctly Finished

Caution The washed items and washing chamber are hot! Always wear protective goggles and gloves when unloading.

Fig 581

Caution There must be no more contaminations (incrustations, deposits) visible.

36/49 001 Operating Instructions WD290

Switching off the device

13 Switching off the device

� Switch the device off with button after use

� Close utility shut-off valves

I

Note All manually operated utility shut-off valves must be closed while the device is not operating.

Note If the device is switched off at the main switch, the controller is no longer active. Consequently, the water level is not checked and, in the event of a broken valve, water can overflow.

Daily maintenance and cleaning tasks

Operating Instructions WD290 001 37/49 © Belimed 10532

14 Daily maintenance and cleaning tasks

14.1 Maintenance in general

The operating company is responsible for carrying out maintenance and cleaning work.

14.2 Maintaining the device

The device must be cleaned and maintained for reasons of hygiene.

� Clean outside surface of the device

1 Operating panel

2 Chrome steel surface

3 HI-MACS Synthetic surface

For outside cleaning, clean each surface of the device with a suitable clean-ing and maintenance agent.

Recommended cleaning agents:

Danger Before performing any maintenance work on components exposed to live electricity, the main switch must be switched off and secured against being switched back on.

Only carry out maintenance and cleaning work wearing safety goggles and gloves! Contamination residues can cause infections!

Caution Never spray the device for cleaning. The device is not waterproof.

HI-MACS Synthetic surface Moist cloth and mild cleaning agent

Operating panel Commercially available glass cleaning agent

Chrome steel surface Maintenance oil

Fig 687

Do not use any solvents for cleaning!

38/49 001 Operating Instructions WD290

Daily maintenance and cleaning tasks

14.3 Maintenance of the lower wash arm

1 Clamp bearing

2 Direction of rotation for loosening

3 Upper bearing bush

4 Lower wash arm

5 Lower bearing bush

6 Supporting bearing

7 Sealing O-ring for clamp bearing

� Twist the clamp bearing (Fig. 177 Pos.1) counter-clockwise and pull it up-wards

� Disassemble the remaining components acc. to Fig. 177

� Check the seal on the clamp bearing (Fig. 177 Pos.7) for damage

� Check wash arm (Fig. 177 Pos.4) for clogged nozzles and clean as required

� Clean the bearing bushes (Fig. 177 Pos.3+5), check for wear and replace as required

Replacement criteria: Score marks or deep scratches

� Reassemble components

� Check rotation of the wash arm

Warning Pointed or sharp objects can cause injuries when cleaning the device.

Fig 177

The rinsing nozzles of the lower wash arm must point upwards!

Daily maintenance and cleaning tasks

Operating Instructions WD290 001 39/49 © Belimed 10532

14.4 Maintenance of the upper wash arm

1 Wash arm sleeve

2 Upper wash arm

3 Cap nut

4 Slide ring

5 Rotor bearing

� Undo cap nut (Fig. 108 Pos.3)

� Disassemble the remaining components acc. to Fig. 108

� Check wash arm (Fig. 108 Pos.2) for clogged nozzles and clean as required

� Check rotor bearing (Fig. 108 Pos.5) for wear and replace as required

Replacement criteria: Score marks or deep scratches

� Reassemble components

� Check rotation of the wash arm

Fig 108

Note Do not lose the slide ring (Fig. 108 Pos.4)!

The rinsing nozzles of the upper wash arm must point downwards!

40/49 001 Operating Instructions WD290

Daily maintenance and cleaning tasks

14.5 Cleaning fine screens and coarse screen

1 Tank heating elements

2 Level floats

3 Coarse screen

4 Fine screen

� Remove fine screens (Fig. 502 Pos.4) and clean as required

� Remove coarse screen (Fig. 502 Pos.3) and clean as required

� Remove foreign objects from washing chamber

� Reinsert coarse screen correctly

� Reinsert fine screens correctly

Fig 502

Caution The tank heating elements can be very hot!

Never operate the device without fine screens and coarse screen!

Device does not clean properly

Operating Instructions WD290 001 41/49 © Belimed 10532

15 Device does not clean properly

15.1 Checking the device

• Has the right program been selected for the items to be washed?

• Do the wash arms rotate? (see Chap. 14 "Daily maintenance and cleaning tasks")

• Are the wash arms correctly installed? (see Chap. 14 "Daily maintenance and cleaning tasks")

• Are the wash arm nozzles clogged? (see Chap. 14 "Daily maintenance and cleaning tasks")

• Are the screens contaminated or not inserted? (see Chap. 14.5 "Cleaning fine screens and coarse screen")

• Does the rack docking system of the device function properly?

• Are the exhaust air, waste water and utility connections correctly estab-lished? (see Chap. 5 "Preparation of the device") The checks must be per-formed by technical support!

15.2 Checking the dosing system

• Are there sufficient amounts of dosage media in the containers? (see Chap.

16.1 "Error display without process termination")

15.3 Checking rack loading

• Are the items to be washed properly loaded on the appropriate rack as spec-ified? (see Chap. 8 "Loading and identifying racks")

• Are the washing nozzles on the rack clogged? (see Chap. 8.1 "Loading racks")

• Is the rack correctly inserted? (see Chap. 10.1 "Manual loading")

• Have the items to be washed been pre-treated as specified? (see Chap. 4

"Pre-treatment of the medical devices")

Warning Wearing protective goggles and gloves is compulsory when handling any dosage media!

Follow safety instructions of the dosage media manufacturer!

42/49 001 Operating Instructions WD290

Errors

16 Errors

16.1 Error display without process termination

If an error occurs while the program is in process, a message is displayed on the operating unit.

Example of a message display:

O Note

O

Dosage Medium 1 Empty O

O

O

� O O O O

Operating unit display Cause Remedy

Dosage medium XXX empty

Container for dosage medium is empty.

Empty indicator float incorrectly fit-ted or defective.

1) Supply new container.

2) Withdraw the empty-indicator lance from the empty container and correctly insert it into the new container.

3) Activate washing program.

Warning!

Always wear protective goggles and gloves when refilling the dosage media!

Follow safety instructions of the dosage media manufacturer!

Error 118

Program recognition

Rack position in washing chamber is not correct.

Reed sensor for "Automatic pro-gram recognition" defective.

Withdraw and reinsert rack.

Inform technical support.

Door locked

Select Pr once more

If the program is terminated with button , the washing chamber door remains locked.

New program can be selected.

Sensor difference is too large

Difference between monitoring sen-sor and control sensor is too large

(+- 2°C).

New program can be selected.

Inform technical support immedi-ately. Recalibrate the sensors at a minimum of 80°C.

Replace filter The sterile filter for the drying sys-tem is clogged.

Inform technical support immedi-ately.

I

Errors

Operating Instructions WD290 001 43/49 © Belimed 10532

16.2 Error display with process termination

If an error occurs while a program is in progress, the process is interrupted auto-matically and the error is indicated on the display.

Example of error display:

16.3 Device will not operate

• Is the main switch turned on? To be checked by technical support only!

• Error is shown on the display? (see Chap. 16 "Errors")

• Is the building power supply interrupted?

• Are the washing chamber doors correctly locked? (see Chap. 5 "Preparation of the device")

• Are the fuses intact? To be checked by technical support only!

Periodic servicing Maintenance prompt after specified number of batches. (Generally every 1500 batches)

New program can be selected.

Initiate service call by contractual partner.

Exhaust facility defective Building exhaust facility failure. New program can be selected.

Inform technical support immedi-ately.

Peak load shutdown The building peak load manage-ment has blocked the device as a load.

A new program cannot be selected.

Wait until it is enabled once again.

No Communication with Batch Doc Syst

Connection to PC for batch record-ing is interrupted.

New program can be selected.

Re-establish connection between device and PC for batch recording.

Operating unit display Cause Remedy

Warning Report error displays with process termination to technical support immedi-ately! Do not continue working with the device under any circumstances!

O Process error Program Name

Error xxx O xxxxxxx

Step x.x:

Date:

Time:

xxxxx xx.xx.xxxx xx:xx

O

Program intervention �

Confirm resolution �

O O O O O

44/49 001 Operating Instructions WD290

Options

17 Options

17.1 Independent Process Data management IPD

With automatic verification, the ongoing process is interrupted with the relevant error message. The function can be switched on and off from the operating unit.

If the function is switched "On" the process is terminated, if switched "Off", only a message is shown on the display.

Activation:

17.2 Built-in printer US / LS

17.2.1 Function

The built-in printer is used for printing out operating data such as program steps, errors and program interruptions.

17.2.2 Replacing the paper roll

� Open flap by pressing left/centre (printer on LS) or right/centre (printer on

US)

� Replace roll

� Close flap. Guide paper through paper slit

� Printer ready for operation again

Verification IPD

On

Fig 655

O Printer:

Printer On/Off/Only in case of error

Printer language:

Selection of printer language from three languages

Test printout:

Direct activation of a test printout

Reprint:

Activation of printout for last batch.

Settings

Printer

On �

Printer language

English EN �

Test printout

Print �

Reprint

Print �

� O � � O

Conformity and certifications

Operating Instructions WD290 001 45/49 © Belimed 10532

18 Conformity and certifications

Belimed AG Dorfstrasse 4 CH-6275 Ballwil

Wir erklären in alleiniger Verantwortung, dass der Reinigungs- und Desinfektionsautomat Nous déclarons sous notre propre responsabilité que l’automate de lavage et de désinfection Under our sole responsibility we herewith declare that the washer and disinfectors

Typ: WD 290 (09) Serien-Nr.:

994000094001

994000094007 nach Anhang IX der Richtlinie 93/42/EWG, als ein Medizinprodukt der Klasse IIA eingestuft wird und gemäss der Bestimmungen der Richtlinien est conforme, selon l’annexe IX de la directive 93/42/CEE sur les dispositifs médicaux de la classe IIA, aux directives des normes according to annex IX of directive 93/42EEC, is rated as a médical device of class IIA and under the terms of reference

93/42/EWG

93/42/CEE

93/42/EEC

mit den folgenden harmonisierten Normen, nationalen Normen oder normativen Dokumenten übereinstimmt.

selon les normes harmonisées, les normes nationales ou autres documents normatifs suivants.

is confirm with the following harmonised standards, national standards or other normative documents.

Sicherheit

EMV

SVGW

Typenprüfung

Konformitätsbewertungsverfahren Procédure d’évaluation de la conformité Conformity assessment procedure

Nach 93/42 EWG, Anhang II (Vollständiges Qualitätssicherungssystem)

Konformitätsbewertungsstelle Organisme notifié Notified Body

TÜV NORD CERT GmbH Langenmarkstrasse 20, 45141 Essen, Gemany

Ballwil, 27. April 2009

W. Schürpf Head Research & Development

E. Ammann Head Application / Process Engineering

KONFORMITÄTSERKLÄRUNG

DÉCLARATION DE CONFORMITÉ

DECLARATION OF CONFORMITY

EN 61010-1: 2001

EN 61326-1: 2006

W/TPW106: 2001

EN ISO 15883-1: 2006

EN 61010-2-040: 2005

EN 61326-3-11: 2000

EN 61326-3-12: 2005

IEC 61010-1: (ed.2)

IEC 61326-1: 2005

EN 61770

IEC 61010-2-040: (ed.1)

IEC 61326-3-11: 2000

IEC 61326-3-12: 2004

46/49 001 Operating Instructions WD290

Glossary

19 Glossary

Authorised persons

Approved persons, more particularly, persons who have been granted certain rights.

Cleaning Removal of contaminations from surfaces to be cleaned by means of an aqueous medium, with or without process chemicals as required.

Controller Device that guides the washer/disinfector step by step through the required phases of the process cycle (or cycles), or the process, in accordance with the specified, process-relevant parameters.

Disinfection Reduction of the number of viable micro-organisms on a product to a predefined level suitable for its continued handling or use.

Error Condition of a functional unit in which it is incapable of fulfilling a required func-tion, not including incapacity due to maintenance work or other planned actions or due to absence of required external agents.

Error display Detection by the automatic controller that the specified process variables for the process cycle of the washer/disinfector were infringed.

Gloves Acid and alkali resistant gloves

Hazard Potential source of damage.

Installation qualification

Illustrative and documenting evidence that the device has been equipped and in-stalled in accordance with the relevant specifications.

Intended use Use of a device in accordance with the specifications laid down in the user in-structions.

Load Collective term used to describe all utensils, appliances and materials that are simultaneously inserted into a washer/disinfector for the purpose of treating them in a process cycle.

LS Loading side

Medical devices All instruments, apparatuses, devices, software, materials or other objects, used by themselves or in connection with each other, including the software specially designed by the manufacturer for diagnostic and/or therapeutic purposes and used for the proper function of the medical device, that are intended by the man-ufacturer to be used in humans for the following purposes:

• Diagnosis, prevention, monitoring, treatment or alleviation of diseases;

• Diagnosis, monitoring, treatment, alleviation or compensation of injuries or disabilities;

• Examination, replacement or modification of the anatomic structure or of a physiological process and whose proper main function in or on the human body is neither achieved by pharmacological, immunological nor metabolic means, but whose mode of action may be supported by such means.

Operators Persons who load and unload the device and perform basic cleaning and main-tenance work.

Operating unit Interface between operator and system. The operating unit may be equipped with buttons, switches or a touch panel.

Operating company Persons or companies who are responsible for use and maintenance of devices.

The operating company is the legal proprietor of the devices.

Performance qualification

System by which the process cycle can be interrupted or modified depending on requirements; illustrative and documenting evidence that the device, as it is in-stalled and operated according to the operating procedures, works consistently in accordance with the predefined criteria and therefore products are obtained

Glossary

Operating Instructions WD290 001 47/49 © Belimed 10532 that fulfil their specifications, i.e. the washing/disinfection device delivers prod-ucts that are cleaned and disinfected according to the required standard.

Protective goggles Acid and alkali resistant fully sealed protective goggles

Rack Device used for correct loading and cleaning of washing utensils.

RKI The mission assigned to the Robert Koch Institute includes both observation of the occurrence of diseases and relevant health hazards in the population, as well as the task of deriving and scientifically establishing the required measures for effective protection of the health of the population.

SOP A Standard Operating Procedure is a document which describes the procedure to be followed within a work process which forms part of the operations designed to achieve the business objectives of an enterprise. Frequently recurring work procedures are described in texts and provided for guidance to the persons im-plementing the tasks.

Tank Container permanently installed in the washer/disinfector for storage of solutions required during the process.

Technical service Ensures proper function of all systems, machines and devices and is responsible for servicing and maintenance work.

US Unloading side

Validation, process validation

Documented procedure for obtaining, recording and interpreting the test results required in order to demonstrate that a procedure consistently complies with the prescribed specifications.

Washer/Disinfector

(WD)

Device used for cleaning and disinfecting medical devices and other objects used in medicine, dentistry, pharmacy and veterinary medicine.

Note: Device types designed specifically for cleaning clothing or other laundry items are not included. Specifications for devices intended for use in sterilization or designated "sterilizers" are laid down in other standards, e.g. EN 285.

Washing chamber The part of the washing/disinfection device in which the load is treated.

Note: Steam generators, piping, e.g. drains and connections, from which the chamber can be disconnected, are not defined as part of it.

Washing chamber door

Device for closing and sealing the chamber.

48/49 001 Operating Instructions WD290

Organisation Belimed AG

20 Organisation Belimed AG

20.1 Manufacturer

Belimed AG, Dorfstrasse 4, CH-6275 Ballwil (Switzerland)

Phone +41 41 449 78 88

Fax +41 41 449 78 89 info@belimed.ch

20.2 Subsidiaries, Customer Service

Belgium

Belimed SA Rue de Clairvaux 8 1348 Louvain-La-Neuve Phone +32 10 42 02 40 Fax +32 10 42 02 49 info@belimed.be

Germany

Belimed Deutschland GmbH Edisonstrasse 7a 84453 Mühldorf am Inn Phone +49 8631 9896 0 Fax +49 8631 9896 300 info@belimed.de

Branch Office West Belimed Deutschland GmbH Emil-Hoffmann-Strasse 27 50996 Köln Phone +49 2236 9642 0 Fax +49 2236 9642 200 info.west@belimed.de

France

Belimed SAS Parc GIVIO 330 Allée des Hetres, Hall E 69760 Limonest Phone +33 4 37 41 63 03 Fax +33 4 37 41 63 04 info@belimed.fr

Pharma Belimed SAS Parc Espale 1, av. Pierre Pflimlin 68390 Sausheim Phone +33 3 89 63 65 40 Fax +33 3 89 63 65 41 info@belimed.fr

United…