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Operating Instructions WD 290 Item Number: 10532-0150-EN Version: 001-07/09
Index of contents
Index of contents
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1
Introduction... 4
1.1
Before you read on... 4
1.2
Target group... 4
1.3
Changes... 4
1.4
Symbols and notices used... 4
2
For your safety... 5
2.1
Intended use... 5
2.2
Care responsibilities for dealing with the device... 5
2.3
Instruction of personnel... 5
2.4
Safety instructions on the device... 5
2.5
Fields of application for the device... 6
2.6
Process validation... 6
3
Device description... 7
3.1
Device loading side (LS)... 7
3.2
Device unloading side (US)... 8
3.3 3.3.1
Operating unit on loading side (LS)... 9 Description of operating unit on loading side... 9
3.4 3.4.1
Operating unit on unloading side (US)... 11 Description of operating unit on unloading side... 11
3.5 3.5.1
Process status display... 12 Process status display description... 12
3.6
Procedure for changing settings... 13
3.7 3.7.1 3.7.2
Alphanumeric entry... 14 Procedure for alphanumeric entry... 14 Operating buttons... 14
4
Pre-treatment of the medical devices... 16
4.1 4.1.1
Responsibility for pre-treatment... 16 SOP (Standard Operating Procedures)... 16
4.2
Preparation of the medical devices... 16
4.3 4.3.1
Pre-cleaning pre-treatment... 17 Impairment of subsequent cleaning... 17
5
Preparation of the device... 18
6
User log-on... 20
6.1
Log-on via operating unit... 20
6.2
Log-on via barcode reader... 22
7
Automatic start and switch-off, Self-disinfection... 23
7.1 7.1.1
Automatic switch-off... 23 Activating and setting the automatic switch-off function... 23
7.2 7.2.1
Automatic start... 24 Activating and setting the automatic start function... 24
7.3 7.3.1 7.3.2
Self-Disinfection... 25 Why self-disinfection?... 25 Activating and setting the self-disinfection function... 25
001 10532
Operating Instructions WD290 © Belimed
Index of contents
7.3.3
Starting self-disinfection... 26
8
Loading and identifying racks... 27
8.1
Loading racks... 27
8.2 8.2.1 8.2.2
Rack identification... 27 Rack identification via operating unit... 27 Rack identification via barcode... 27
9
Batch content identification... 28
9.1
Batch identification via barcode... 28
10
Loading... 29
10.1
Manual loading... 29
10.2
Automatic loading and unloading (optional)... 31
11
Washing and disinfection... 32
11.1
General instructions... 32
11.2
Washing, disinfecting and drying... 32
12
Unloading... 35
13
Switching off the device... 36
14
Daily maintenance and cleaning tasks... 37
14.1
Maintenance in general... 37
14.2
Maintaining the device... 37
14.3
Maintenance of the lower wash arm... 38
14.4
Maintenance of the upper wash arm... 39
14.5
Cleaning fine screens and coarse screen... 40
15
Device does not clean properly... 41
15.1
Checking the device... 41
15.2
Checking the dosing system... 41
15.3
Checking rack loading... 41
16
Errors... 42
16.1
Error display without process termination... 42
16.2
Error display with process termination... 43
16.3
Device will not operate... 43
17
Options... 44
17.1
Independent Process Data management IPD... 44
17.2 Built-in printer US / LS... 44 17.2.1 Function... 44 17.2.2 Replacing the paper roll... 44 18
Conformity and certifications... 45
19
Glossary... 46
20
Organisation Belimed AG... 48
20.1
Manufacturer... 48
20.2
Subsidiaries, Customer Service... 48
21
Notes... 49
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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 following personnel: Installation instructions
Installer; Operating company; Technical support
Operating instructions
Operator; Operating company; Technical support
Technical manual
Operating company; Technical support
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 documentation are important to avoid harm to health and life. Danger Indicates a hazard with high risk which, if not avoided, causes death or serious 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.
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Operating Instructions WD290 © Belimed
For your safety
2
For your safety We affirm with the EC Declaration of Conformity and the CE mark 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 and in laboratories. All other applications are considered as non-intended use.
2.2
2.3
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 according 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
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.
2.4
Safety instructions on the device Warning"Dangerous voltage"
Warning"Hot surface"
Warning"Caustic substances" Follow safety instructions of the dosage media manufacturer!
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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 Warning No single-use products may be reconditioned! Always adhere to the instructions of the medical device manufacturer!
2.6
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 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.
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Operating Instructions WD290 © Belimed
Device description
3
Device description 3.1
Device loading side (LS)
1
2
3 9
4
5
8 6
7
Fig 496
1 2 3 4 5 6 7 8 9
Operating Instructions WD290 © Belimed
Process status display Operating unit Safety switch actuator Washing chamber door Emergency Stop Lower front panel Location of power rating plate Transfer cart Rack
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Device description
3.2
Device unloading side (US)
1
5
2 4
3
Fig 497
1 2 3 4 5
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Process status display Washing chamber door Lower front panel Emergency Stop Operating unit
001 10532
Operating Instructions WD290 © Belimed
Device description
3.3
Operating unit on loading side (LS) 1) Menu button 2) Display – Displays the status bar, communication bar, activity bar, selection options
1
3) Selection buttons
2
4) Confirmation button <OK> 5) On/Off button
3
6) Activity buttons
4 5
6
3.3.1
Fig 499
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 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
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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 Symbol Description
Symbol Description
Scroll wheel Home
Scroll wheel Info
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 number of pages is additionally displayed in the activity bar. Activity bar icons 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
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No user logged on
New user
Program pause
Program start
Deactivate door contact pressure
Activate door contact pressure
001 10532
Operating Instructions WD290 © Belimed
Device description
3.4
Operating unit on unloading side (US)
a
b
1) LED Displays – a) LED Red flashes - Warning active; LED Red lights permanently - error active – b) LED Green lights permanently Program cycle active – c)LED Green lights permanently Doors locked
1
c
2 3
2) Display – Displays the Status bar, activity bar 3) Activity button
Fig 500
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 Symbol Description
Symbol Description
Automatic system active
Automatic system inactive
Doors locked
Operating Instructions WD290 © Belimed
Doors open
Doors closed
Door on loading side open
Door on unloading side open
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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 Symbol Description
3.5
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 settings
User setting, display settings for unloading side
Process status display
*
•
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
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 current operating status of the device.
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Operating Instructions WD290 © Belimed
Device description
Display while program is in progress:
3.6
•
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.
Procedure for changing settings Example - Setting the date: O Settings Operating language German
09.02.2009
Monday
07:15
Date
Weekday
Time
O 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
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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: 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
_
-
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 defined 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. S a mp l e
t e x t
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 character, the cursor returns to the first character again.
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Device description
Confirmation button Icon:
OK
Icon description:
Confirmation button
Function when activated:
Display reverts to original screen; the edited text is saved
Activity buttons Icon: Icon description:
Back
Function when activated:
Display reverts to original screen; the edited text is not saved
Icon:
>
Icon description:
Capital letters
Function when activated:
Screen switches Screen switches Screen switches to capital letters to lower case to numbers letters
>
>
>
Lower case letters
>
>
Numbers
Icon: Icon description:
Delete
Function when activated:
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 Identification"; Display <NIdent>; when a character is entered, the function switches to "Delete" -activity
Icon: Icon description:
Cursor forward
Function when activated:
Cursor moves forward one position
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Pre-treatment of the medical devices
4
Pre-treatment of the medical devices 4.1
Responsibility for pre-treatment Caution Always observe the manufacturer's specifications for the medical device to be treated! 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 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, articulated instruments...). Special attention should be given to the lumina. Disassemble MIS or other complex instruments according to the manufacturer's specifications.
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Pre-treatment of the 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
Impairment of subsequent cleaning Various treatments fix proteins and may contribute to preserving prion infectiosity. 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.
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Preparation of the device
5
Preparation of the device 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 maintenance work (see Chap. 14 "Daily maintenance and cleaning tasks").
Open utility supply Check the quantity of dosage media (see Chap. 16 "Errors") Switch the device on with button I (see Chap 3.3 "Operating unit on loading side (LS)"). The start screen appears on the operating unit Table 1: Start screen Program P01
Program Name
P02
Program Name
P03
Program Name
P04
Program Name O
O
Press the menu button (see Fig. 686). The menu screen is displayed 1
2
3 Fig 686
1 2 3
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Menu Menu button Operating mode
001 10532
Operating Instructions WD290 © Belimed
Preparation of the device
Table 2: Menu screen 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
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
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User log-on
6
User log-on The user must log on each time before using the device. The log-on data are forwarded to the printer or the digital documentation system and assigned to the respective 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. Program P01
Program Name
P02
Program Name
P03
Program Name
P04
Program Name
O O Select program. The background of the selected program is displayed in a light shade Confirm selection by pressing <OK> -Button. User log-on appears O Log on User 01
User 02
User 03
User 04
O O Select list. The display for user password entry appears Enter user password via operating unit Display: O User password *****
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