BELIMED WD 290 User manual

Instruction Manual
WD290
Article number: 10268-0068
Version: 001-03/08

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001 Instruction Manual WD290
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Inhaltsverzeichnis
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Before you read on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Target group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 Amendments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4 Symbols and references used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2 For your safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2 Duty of care in handling the device. . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3 Non-intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.4 Instruction of personnel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.5 Fields of application for the device . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.6 Process validation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1 Device unclean side (US) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 Device clean side (CS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.3 Controller unclean side (US). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.4 Controller clean side (CS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4 Pre-treating medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.1 Responsibility for pre-treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.1.1 SOPs (Standard Operating Procedures) . . . . . . . . . . . . . . . . . . . . 10
4.2 Preparing medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.3 Pre-cleaning pre-treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.3.1 Avoiding subsequent cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5 Preparing the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6 Self-disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6.1 Why self-disinfection? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6.2 Starting self-disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7 User identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.1 Identification via operating panel . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.2 Identification via barcode reader. . . . . . . . . . . . . . . . . . . . . . . . . . . 16
8 Loading and identifying racks . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.1 Loading racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.2 Rack identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.2.1 Rack identification via the operating panel . . . . . . . . . . . . . . . . . . . 17
8.2.2 Rack identification via barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
9 Identification of batch content. . . . . . . . . . . . . . . . . . . . . . . . . . . 18
9.1 Batch content identification via operating panel . . . . . . . . . . . . . . . 18
9.2 Batch content identification via barcode . . . . . . . . . . . . . . . . . . . . . 18
10 Loading from the unclean side . . . . . . . . . . . . . . . . . . . . . . . . . . 19
10.1 Manual loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
10.2 Automatic rack station (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . 21
11 Washing and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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11.1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
11.2 Washing, disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
12 Unloading from the clean side. . . . . . . . . . . . . . . . . . . . . . . . . . . 23
13 Switching off the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
14 Daily servicing and cleaning work . . . . . . . . . . . . . . . . . . . . . . . 25
14.1 Servicing in general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
14.2 Servicing the bottom washing arm . . . . . . . . . . . . . . . . . . . . . . . . . 25
14.3 Servicing the top washing arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
14.4 Cleaning the surface sieve and coarse sieve . . . . . . . . . . . . . . . . . 27
15 Device fails to clean properly . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
15.1 Checking the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
15.2 Checking dosing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
15.3 Checking rack loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
16 Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
16.1 Fault text without process interruption . . . . . . . . . . . . . . . . . . . . . . 29
16.2 Fault text with process interruption . . . . . . . . . . . . . . . . . . . . . . . . . 30
16.3 Device does not run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
17 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
17.1 Modem connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
17.1.1 Activating the connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
17.2 Independent measurement data acquisition IPD . . . . . . . . . . . . . . 31
17.3 Tank heating manually switchable . . . . . . . . . . . . . . . . . . . . . . . . . 32
17.3.1 Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
17.3.2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
17.4 Built-in printer CS / US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
17.4.1 Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
17.4.2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
17.4.3 Changing paper rolls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
17.5 Emergency stop CS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
17.5.1 Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
17.5.2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
18 Conformity and certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
19 Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
20 Organisation Belimed AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
20.1 Manufacturer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
20.2 Subsidiaries, Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
21 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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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 own-
er, users, operators, as well as servicing personnel. They must be accessible for
this group of persons.
1.3 Amendments
The text, graphics and data correspond to the technical status of the product at
the time of going to print. Amendments in the sense of technical development re-
main reserved.
1.4 Symbols and references used
The following symbols and references to occupational safety used throughout
the documentation are important to avoid harm to health and life.
DANGER!
There is an imminent risk to the life and health of persons.
WARNING!
There may be a risk to the life and health of persons.
CAUTION!
A situation for which there is a warning of damage to property and equip-
ment.
NOTE
User tips and useful information on the best possible use of the equipment.

For your safety
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2 For your safety
With the EC Declaration of Conformity and the CE mark, we affiirm 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, clinical
laboratories and in industry.
2.2 Duty of care in handling the device
• Only use original racks, spare parts and accessories
•Load the racks as intended (see Chap. 8 "Loading and identifying racks")
•Daily servicing work on the device must be carried out regularly and in ac-
cordance with regulations (see Chap. 14 "Daily servicing and cleaning work")
•Validation of the programme parameters must be performed regularly (see
Chap. 2.6 "Process validation")
•Installation, deinstallation, servicing or modification must only be carried
out by persons authorised by Belimed
• In the case ofincorrectly installed, operated or maintained devices all
warranty claims are invalidated
2.3 Non-intended use
All other applications are considered as non-intended use.
Damages caused by operator error, non-intended use, failure to observe the in-
structions, operation by untrained personnel, unauthorised modifications and
conversions without the written consent of the manufacturer, are not permitted
and preclude the manufacturer's liability for the ensuing damage to property and
personal injury.
2.4 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.

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For your safety
2.5 Fields of application for the device
Cleaning and conditioning of:
• Surgical instruments
• Minimal-invasive instruments
• Instruments for anaesthesia and intensive care
• Baby bottles and teats
• Containers
• OP shoes
• Laboratory instruments from 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
(refer to appendix EN ISO 15883-1 November 2001, Chap. 6, Pages 35-37)
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, programmes,
chemicals) which have been validated together.
The safety of operators and patients may be compromised if the devices
used are not validated in accordance with regulations.

Device description
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3 Device description
3.1 Device unclean side (US)
1 Door drive (behind the panel)
2 Wash compartment doors made of double-layer safety glass
3 Operating panel
4 Main switch (with EMERGENCY OFF function)
5 Service panel
6 Location type plate
7 Transfer trolley
8 Rack
9 Automatic wash compartment doors
10 Door safety switching strip
1
3
4
5
2
8
7
9
10
Abb 201
6

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Device description
3.2 Device clean side (CS)
1 Door drive (behind the panel)
2 Operating panel with door button
3 Wash compartment doors made of double-layer safety glass
4 Service panel
1
2
4
3
Abb 301

Device description
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3.3 Controller unclean side (US)
3.4 Controller clean side (CS)
1) Display
– With screensaver "BELIMED INFEC-
TION CONTROL"; this means that
this display automatically appears af-
ter approx. 1 h. Press any button, dis-
play"Program ready" appears again
2) Cursor left
– Print operating data such as program
formula and setup parameters
– Self disinfection On/Off
– IPD verification On/Off
3) Cursor right
– Acoustic signal On/Off
4) Cursor down
– Printer On/Off
5) Cursor up
– Shift button Programs P7 - P12
6) Program buttons
– Selection of Programs P1 - P6, with
Shift P7 - P12
7) Door button
– Opens/close door
8) On/Off button
– Display batch number (press 4 sec-
onds)
1
2
3
4
5
6
Program 1
Program 2
Program 3
Program 4
Program 5
Program 6
1
432
5
6
7
8
Abb 179
1) Display
– With screensaverBELIMED INFEC-
TION CONTROL; this means that this
display automatically appears after
approx. 1 h. Press any button, dis-
play"Program ready" appears again
2) Door button
– Door opens/closes
3) RUN
LED lit = In progress
4) ERROR
LED lit = Fault
(See Chap. 16 "Faults")
RUN
ERROR
1
2
Abb 178
4
3

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Pre-treating medical devices
4 Pre-treating medical devices
4.1 Responsibility for pre-treatment
The owner is responsible for pre-treatment of medical devices. The best possible
washing results are only to be achieved with correct pre-treatment as intended.
Various treatments fix proteins and may contribute to preserving prion infectivity.
4.1.1 SOPs (Standard Operating Procedures)
The contents of the following criteria and specifications must be regulated:
• Product responsibility
• Transport routes and duration of waste disposal (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 Preparing medical devices
All inner and outer surfaces must be accessible for cleaning (open valves, taps,
joint instruments...) Special caution is required for the lumen. Disassemble MIC
or other complex instruments according to the manufacturer's specifications.
CAUTION!
Always observe the specifications from the medical device manufacturer!
CAUTION!
The air bubbles in the foam prevent pressure building-up in the cleaning sys-
tem and therefore the best possible contact between the cleaning agent and
the items to be washed.
CAUTION!
Not all medical devices are suitable for mechanical reconditioning (see Chap.
2.5 "Fields of application for the device")

Pre-treating medical devices
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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 Avoiding subsequent cleaning
Various treatments fix proteins and may contribute to preserving prion infectivity.
The following pre-treatment methods may cause impairments in subsequent
washing:
• Pre-treatment with aldehydic disinfectants
• Pre-treatment with alcohol solutions
• Pouring antiseptic solutions on the items to be rinsed
• Aldehyde and alcohol vapours
• Heat pre-treatment
Small quantities of foam are permissible with manual cleaning in the immersion
bath or ultrasonic cleaning.

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Preparing the device
5 Preparing the device
Check the quantity of detergents (see Chap. 16 "Faults")
Switch the device on at the main switch (Fig. 209) with the button. Four
possible display texts may now appear
Performing self-disinfection
(See Chap. 6 "Self-disinfection")
Display text:
Program ready
Continue with program flow (see Chap. 7 "User identification")
Display text:
Fault without process interruption
Rectify fault (see Chap. 16 "Faults")
Example display text:
Fault with process interruption
Report to the technical specialist
Example display text:
WARNING!
Only operate the device if it is in a technically faultless condition! Damaged or
defected components must be reported to the technical specialist.
After a prolonged period of disuse (approx. 1 week), the daily servicing work
must be carried out to prepare the device (see Chap.14 "Daily servicing and
cleaning work").
Self-disinfection
Start
Program ready
Dosing device
Empty
No pressure
Fault Code 110
0 I
Abb 209

Self-disinfection
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6 Self-disinfection
6.1 Why self-disinfection?
Microorganisms form in the washing chamber, tubing and DI boiler after a pro-
longed period of disuse. Following thermal disinfection step, residues of dead
bacteria on the medical device may constitute a risk for patients.
In the case ofactive self-disinfection the owner is requested to perform self-dis-
infection after a programmed period (24 hours as standard) following the last pro-
gram run.
6.2 Starting self-disinfection
Open the door with the button
Slide in the empty rack
Close the wash compartment door with the button
User identification (see Chap. 7 "User identification")
The device is ready to start
Display text:
Press any program button to
Display text:
Legend:
SD |_| = program step status
13min = remaining run time
Desinf = program name
A068 = current A
0
value
89°C = temperature of rinsing agent or drying air
NOTE
If there is no mains supply (mains switch OFF) the timer is not active, as the
request for"Self Disinfection Start" always appears when active self-disinfec-
tion is switched on.
CAUTION!
Do not wash any items with the self-disinfection program! There is no cold
pre-rinse. There is the risk of excessive foam formation and fixing proteins.
WARNING!
Do not touch the door or its surrounding paneling during the closing process.
A crushing hazard exists.
If any objects are trapped between the panel and door, the technical person-
nel must be informed to rectify the problem.
Self Disinfection
Start
SD |_| 13min
Desinf A068 89°C
1
6

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Self-disinfection
Procedure in case of faults:
If a fault occurs during operation, acknowledge with the button
If the fault persists (see Chap. 16 "Faults")
If the fault cannot be rectified, the technical specialist must be informed
The end of the program is indicated with an acoustic signal
Display text:
0 I
DANGER!
If smoke is emitted or water escapes, immediately turn off at the main
switch and isolate the device from the mains supply. Inform the technical
specialist.
Program name
Correctly Finished
NOTE
For manual loading/unloading, unload the rack back to the US again at the
end of the program. The CS door remains locked.
Self-disinfection is inactive for automatic loading/unloading.

User identification
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7 User identification
The user must logon each time before using the device. The password identifi-
cation is forwarded to the printer or the digital documentation system and as-
signed to the relevant batch.
Detection takes place via the operating panel or by means of barcode reader.
7.1 Identification via operating panel
User identification is requested once the device is switched on.
Inputting the identification number via the operating panel
Example 1:
Device ready
Display text:
Display text for a prolonged period of disuse (see Chap. 6 "Self-disinfection"):
User Name o No.?
--
NOTE
For input via the operating panel we recommend a list of numbers with the
corresponding names (Example 1).
The identification number must lie within the range 11-65. Only the digits 1-6
can be used for a number. (Not possible: 17, 18, 19, 27, 28, 29....)
For an input of No. 0 or 66 "No identification" is output.
No. Name
11 M. Smith
12 H. Jones
0 No Identification
66 No Identification
Program ready
Self Disinfection
Start

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User identification
7.2 Identification via barcode reader
User identification is requested once the device is switched on.
Display text:
Reading the barcode with the barcode reader
Display text:
Example 2:
Program ready
Display text:
Display text for a prolonged period of disuse (see Chap. 6 "Self-disinfection"):
User Name o No.?
--
NOTE
The length of the name input is limited to 20 characters. If the no. 0 or 66 is
read"No identification" is output (see Example 2)
Barcodes for name labels can be produced oneself from the Internet (free of
charge). (http://www.barcodemagic.com/barcodemagic.html).
First name / last name
Heike Meyer
No Identification
0 / 66
Program ready
--.--.---- --:--
Self Disinfection
Start
Abb 182

Loading and identifying racks
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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 document system
and assigned to the relevant batch.
Detection takes place via the operating panel or by means of barcode reader.
8.2.1 Rack identification via the operating panel
Display text:
Inputting the identification number via the operating panel
8.2.2 Rack identification via barcode
Display text:
Read barcode
DANGER!
Always wear protective goggles and gloves when handling the items to be
washed. Soiled items to be washed may cause infections!
Rack Name o No.?
--
NOTE
The identification number must lie within the range 11-65. Only the digits 1-6
can be used for a number. (Not possible: 17, 18, 19, 27, 28, 29....)
For an input of No. 0 or 66 "No identification" is output.
Rack Name o No.?
--
NOTE
The length of the name input is limited to 12 characters. If the no. 0 or 66 is
read"No identification" is output (see Chap. 7.2 "Identification via barcode
reader")
Barcodes can be produced oneself from the Internet (free of charge). (http://
www.barcodemagic.com/barcodemagic.html).

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Identification of batch content
9 Identification of batch content
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 content identification via operating panel
Display text:
Inputting the identification number via the operating panel
9.2 Batch content identification via barcode
Display text:
Reading the batch content with the barcode reader
Example:
Read Content No.
No=--?
NOTE
The identification number must lie within the range 11-65. Only the digits 1-6
can be used for a number. (Not possible: 17, 18, 19, 27, 28, 29....)
For an input No. 66 "No identification" is output.
A maximum of 18 objects can be identified. The same number cannot be
input twice. Always complete input with 66.
Quantity of Contents
--
NOTE
The reading process can be cancelled with the button. Always conclude
with no. 66.
Reading is terminated after reaching a max. 18 batch contents.
0 I
NOTE
The length of the name input is limited to 12 characters. If the no. 0 or 66 is
read "No identification" is output (see Chap. 7.2 "Identification via barcode
reader")
Barcodes can be produced oneself from the Internet (free of charge). (http://
www.barcodemagic.com/barcodemagic.html).
Abb 227

Loading from the unclean side
Instruction Manual WD290 001
19/39
© Belimed 10268
10 Loading from the unclean side
10.1 Manual loading
Attach the transfer trolley with the loaded rack to the device (Fig. 203 Pos. 1)
1 Attachment and detachment hook
2 Rack
3 Locking hook
4 Transfer trolley
Open the washing compartment with the button
Slide the loaded rack into the washing chamber (Fig. 203)
- Rack docking must coincide with the device docking
- The rack has to lock into the guide (Fig. 168)
DANGER!
Always wear protective goggles and gloves when loading. Soiled items to
be washed may cause infections!
1
3
2
4
Abb 203
CAUTION!
Sharp or pointed objects may fall down when sliding the rack. This can cause
injuries.
The rinsing arms must not be blocked by too high objects or objects
protruding downwards. Check rotation by hand!

20/39
001 Instruction Manual WD290
10268 © Belimed
Loading from the unclean side
1 Rack
2 Rack downholder
Close the washing compartment with the button
The device is ready to start.
Abb 168
1
2
WARNING!
Do not touch the door or its surrounding panel during the closing process. A
crushing hazard exists.
If any objects are trapped between the panel and door, the technical person-
nel must be informed to rectify the problem.
Program ready
dd.mm.20yy hh:mm
NOTE
Check that the date and time are correct. This is important for the batch doc-
umentation. Report discrepancies to the technical specialist!
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3
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