Instruction Manual
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Instruction Manual WD290 Article number: 10268-0068 Version: 001-03/08
Inhaltsverzeichnis
2/39
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 4.1.1
Responsibility for pre-treatment... 10 SOPs (Standard Operating Procedures)... 10
4.2
Preparing medical devices... 10
4.3 4.3.1
Pre-cleaning pre-treatment... 11 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 8.2.1 8.2.2
Rack identification... 17 Rack identification via the operating panel... 17 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... 22 001 10268
Instruction Manual WD290 © Belimed
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
Instruction Manual WD290 © Belimed
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 owner, 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 remain 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 equipment.
NOTE User tips and useful information on the best possible use of the equipment.
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For your safety
2
For your safety With the EC Declaration of Conformity and the CE mark, we affiirm that this product 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
2.3
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 accordance 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
Non-intended use All other applications are considered as non-intended use. Damages caused by operator error, non-intended use, failure to observe the instructions, 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 understood. 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:
2.6
•
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
Process validation The aim of process validation is to achieve a high level of safety in the reconditioning of medical devices in order to afford the operators and patients the greatest 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.
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Device description
3
Device description 3.1
Device unclean side (US)
10 9 1
2
8
3
4
7 5
6
Abb 201
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
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Device description
3.2
Device clean side (CS)
1 2
3
4
Abb 301
1 2 3 4
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Door drive (behind the panel) Operating panel with door button Wash compartment doors made of double-layer safety glass Service panel
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Device description
3.3
Controller unclean side (US) 1) Display – With screensaver "BELIMED INFECTION CONTROL"; this means that this display automatically appears after approx. 1 h. Press any button, display"Program ready" appears again
1 2
3
4
5
Program 1
1
Program 2
2
Program 3
3
Program 4
4
Program 5
5
Program 6
6
2) Cursor left – Print operating data such as program formula and setup parameters – Self disinfection On/Off – IPD verification On/Off
6
3) Cursor right – Acoustic signal On/Off 4) Cursor down – Printer On/Off
7
8
5) Cursor up – Shift button Programs P7 - P12 6) Program buttons – Selection of Programs P1 - P6, with Shift P7 - P12
Abb 179
7) Door button – Opens/close door 8) On/Off button – Display batch number (press 4 seconds)
3.4
Controller clean side (CS) 1) Display – With screensaverBELIMED INFECTION CONTROL; this means that this display automatically appears after approx. 1 h. Press any button, display"Program ready" appears again
3
1 RUN ERROR
2
2) Door button – Door opens/closes
4
3) RUN LED lit = In progress 4) ERROR LED lit = Fault (See Chap. 16 "Faults")
Abb 178
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Pre-treating medical devices
4
Pre-treating medical devices 4.1
Responsibility for pre-treatment CAUTION! Always observe the specifications from the medical device manufacturer!
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. CAUTION! The air bubbles in the foam prevent pressure building-up in the cleaning system and therefore the best possible contact between the cleaning agent and the items to be washed.
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 CAUTION! Not all medical devices are suitable for mechanical reconditioning (see Chap. 2.5 "Fields of application for the device") 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.
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Pre-treating medical devices
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 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"). Check the quantity of detergents (see Chap. 16 "Faults") Switch the device on at the main switch (Fig. 209) possible display texts may now appear
0I
with the button. Four
Abb 209
Performing self-disinfection (See Chap. 6 "Self-disinfection") Display text: Self-disinfection Start
Program ready Continue with program flow (see Chap. 7 "User identification") Display text: Program ready
Fault without process interruption Rectify fault (see Chap. 16 "Faults") Example display text: Dosing device Empty
Fault with process interruption Report to the technical specialist Example display text: No pressure Fault Code 110
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Self-disinfection
6
Self-disinfection 6.1
Why self-disinfection? Microorganisms form in the washing chamber, tubing and DI boiler after a prolonged 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-disinfection after a programmed period (24 hours as standard) following the last program run. 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-disinfection is switched on.
6.2
Starting self-disinfection Open the door with the
button
Slide in the empty rack 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. Close the wash compartment door with the button User identification (see Chap. 7 "User identification") 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 personnel must be informed to rectify the problem. The device is ready to start Display text: Self Disinfection Start
Press any program button
1 to
6
Display text: SD |_| Desinf
13min A068
89°C
Legend: SD |_| = program step status 13min = remaining run time Desinf = program name A068 = current A0 value 89°C = temperature of rinsing agent or drying air
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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 0I
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. The end of the program is indicated with an acoustic signal Display text: 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.
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User identification
7
User identification The user must logon each time before using the device. The password identification is forwarded to the printer or the digital documentation system and assigned 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. User Name o No.? --
Inputting the identification number via the operating panel 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. Example 1: No.
Name
11
M. Smith
12
H. Jones
0
No Identification
66
No Identification
Device ready Display text: Program ready
Display text for a prolonged period of disuse (see Chap. 6 "Self-disinfection"): 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: User Name o No.? --
Reading the barcode with the barcode reader 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). Display text: Example 2:
Abb 182
First name / last name Heike Meyer No Identification 0 / 66 Program ready Display text: Program ready --.--.----
--:--
Display text for a prolonged period of disuse (see Chap. 6 "Self-disinfection"): Self Disinfection Start
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Loading and identifying racks
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 instructions supplied with the rack. DANGER! Always wear protective goggles and gloves when handling the items to be washed. Soiled items to be washed may cause infections!
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: Rack Name o No.? --
Inputting the identification number via the operating panel 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.
8.2.2
Rack identification via barcode Display text: Rack Name o No.? --
Read barcode 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 documentation 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: Read Content No. No=--?
Inputting the identification number via the operating panel 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.
9.2
Batch content identification via barcode Display text: Quantity of Contents --
Reading the batch content with the barcode reader NOTE The reading process can be cancelled with the with no. 66.
0I
button. Always conclude
Reading is terminated after reaching a max. 18 batch contents. 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). Example:
Abb 227
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Loading from the unclean side
10 Loading from the unclean side DANGER! Always wear protective goggles and gloves when loading. Soiled items to be washed may cause infections!
10.1 Manual loading Attach the transfer trolley with the loaded rack to the device (Fig. 203 Pos. 1)
2
1 3
4
Abb 203
1 2 3 4
Attachment and detachment hook Rack Locking hook 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) 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!
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Loading from the unclean side
1 2
Abb 168
1 2
Rack Rack downholder
Close the washing compartment with the
button
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 personnel must be informed to rectify the problem. The device is ready to start. Program ready dd.mm.20yy
hh:mm
NOTE Check that the date and time are correct. This is important for the batch documentation. Report discrepancies to the technical specialist!
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