L500-300 AEN
Table of Contents
1.
2.
3.
4.
5.
6.
INTRODUCTION................................................................................................................................................... 1
1.1
SCOPE ...................................................................................................................................................... 1
1.2
FOREWORD ............................................................................................................................................. 1
1.3
APPLICABLE EUROPEAN DIRECTIVES/NORMS ................................................................................... 1
1.4
INTENDED USE ........................................................................................................................................ 1
1.5
SYMBOLS DISPLAYED ON THE STERILIZER ........................................................................................ 2
1.6
GENERAL AND SAFETY RECOMMENDATIONS .................................................................................... 2
UNPACKING ........................................................................................................................................................ 3
2.1
UNPACKING THE STERILIZER ................................................................................................................ 3
2.2
STANDARD ACCESSORIES .................................................................................................................... 3
UNIT DESCRIPTION ............................................................................................................................................ 4
3.1
FRONT VIEW ............................................................................................................................................ 4
3.2
SERVICE DOOR ....................................................................................................................................... 4
3.3
REAR VIEW ............................................................................................................................................... 5
3.4
DESCRIPTION OF THE INTERNAL WATER TANKS ............................................................................... 6
3.5
CHAMBER RACK ...................................................................................................................................... 7
3.6
USABLE SPACE IN THE CHAMBER ........................................................................................................ 7
INSTALLATION .................................................................................................................................................... 8
4.1
SETUP ....................................................................................................................................................... 8
4.1.1
Securing the sterilizer with a safety bracket ................................................................................. 8
4.2
ELECTRICAL POWER SUPPLY ............................................................................................................... 9
4.3
PRINTER (optional) ................................................................................................................................... 9
4.4
LISAWARE - CONNECTING THE STERILIZER TO A COMPUTER (optional) ....................................... 10
4.4.1
LAN connection ......................................................................................................................... 10
4.4.2
Serial connection ....................................................................................................................... 10
4.5
DEMINERALIZER (optional) .................................................................................................................... 11
4.5.1
Connecting an external water supply system (demineralizer) .................................................... 11
4.6
CONTINUOUS DRAINING (optional) ...................................................................................................... 11
4.6.1
Connecting the drain tube .......................................................................................................... 11
GETTING STARTED .......................................................................................................................................... 12
5.1
THE USER INTERFACE ......................................................................................................................... 12
5.2
INITIAL WARNINGS AND SLEEP MODE ............................................................................................... 13
5.3
DATE-CLOCK SETTING ......................................................................................................................... 13
5.4
FILLING THE CLEAN WATER TANK ...................................................................................................... 14
5.4.1
Manual filling .............................................................................................................................. 14
5.4.2
Automated water supply (optional) ............................................................................................ 14
5.5
DRAINING THE USED WATER TANK .................................................................................................... 15
5.5.1
Manual draining ......................................................................................................................... 15
5.5.2
Continuous draining ................................................................................................................... 15
5.6
MEMORY CARD ..................................................................................................................................... 15
5.6.1
Inserting / removing the memory card ....................................................................................... 15
PROGRAMMING ................................................................................................................................................ 16
6.1
SETUP MENU ......................................................................................................................................... 16
6.1.1
Language ................................................................................................................................... 16
6.1.2
Sleep mode................................................................................................................................ 17
6.1.3
Printer ........................................................................................................................................ 17
6.1.4
Label printer (available only when a LisaSafe label printer is connected) .................................. 17
6.1.5
Automatic printing (available only when a LisaSafe label printer is connected) ......................... 17
6.1.6
Manual printing (available only when a LisaSafe label printer is connected) ............................. 17
6.1.7
Storage time/weeks (available only when a LisaSafe label printer is connected) ...................... 17
6.1.8
User name ................................................................................................................................. 17
6.1.9
Date-Clock setting ..................................................................................................................... 17
6.1.10 Date format ................................................................................................................................ 18
6.1.11 Clock format............................................................................................................................... 18
6.1.12 Display contrast ......................................................................................................................... 18
6.1.13 Display backlight ........................................................................................................................ 18
6.1.14 Acoustic tones ........................................................................................................................... 18
6.1.15 Night cycle shortcut ................................................................................................................... 19
6.1.16 Connection to PC/Log ................................................................................................................ 20
6.1.17 RSDATA port selection .............................................................................................................. 20
6.2
TEST CYCLES ........................................................................................................................................ 21
6.3
DELAYED CYCLE START ...................................................................................................................... 22
6.4
CYCLE HISTORY .................................................................................................................................... 23
6.5
MAINTENANCE ....................................................................................................................................... 24
6.6
SERVICE ................................................................................................................................................. 24
6.7
UTILITY ................................................................................................................................................... 24
a
6.7.1
System info ................................................................................................................................ 25
6.7.2
Formatting the memory card ...................................................................................................... 25
6.8
USER AUTHENTICATION ...................................................................................................................... 25
6.9
FUNCTIONS AVAILABLE FOR THE ADMINISTRATOR ........................................................................ 26
6.9.1
Access the administrator functions ............................................................................................ 26
6.9.2
Modifying a user name .............................................................................................................. 27
6.9.3
Changing the administrator’s password ..................................................................................... 28
6.9.4
Resetting a user’s password to the default value (0000) ........................................................... 29
6.9.5
Deleting a user........................................................................................................................... 30
6.9.6
Adding a new user ..................................................................................................................... 31
6.9.7
Setting the user identification options for all users ..................................................................... 32
6.10 FUNCTIONS AVAILABLE TO THE OPERATOR(S): PASSWORD MODIFICATION .............................. 33
6.11 STARTING AND ENDING A STERILIZATION CYCLE WITH IDENTIFICATION OF THE USER .......... 35
6.11.1 Starting a sterilization cycle ....................................................................................................... 35
6.11.2 End of a sterilization cycle ......................................................................................................... 36
7.
RUNNING A STERILIZATION CYCLE .............................................................................................................. 37
7.1
THE AVAILABLE STERILIZATION CYCLES .......................................................................................... 37
7.1.1
Starting a sterilization cycle ....................................................................................................... 39
7.1.2
ECO-Dry feature ........................................................................................................................ 39
7.1.3
Cycle in-progress ....................................................................................................................... 40
7.1.4
End of cycle ............................................................................................................................... 40
7.2
MANUAL STOP ....................................................................................................................................... 41
7.3
REAL-TIME CYCLE DATA INFORMATION ............................................................................................ 42
7.4
CYCLE DATA SUMMARY ....................................................................................................................... 43
8.
DISPLAY MESSAGES ....................................................................................................................................... 44
9.
ALARMS ........................................................................................................................................................... 46
10. ALARM CODE TABLE ....................................................................................................................................... 47
11. MAINTENANCE ................................................................................................................................................. 49
11.1 MAINTENANCE PROGRAM ................................................................................................................... 49
11.2 CLEANING THE DOOR SEAL ................................................................................................................ 50
11.3 CLEANING THE CHAMBER AND CHAMBER COMPONENTS ............................................................. 50
11.4 CLEANING THE CHAMBER FILTER ...................................................................................................... 50
11.5 CLEANING THE EXTERNAL STERILIZER SURFACES ........................................................................ 51
11.6 REPLACING THE BACTERIOLOGICAL FILTER .................................................................................... 51
11.7 REPLACING THE DUST FILTER ............................................................................................................ 51
11.8 CLEANING THE WATER TANKS ........................................................................................................... 52
11.9 REPLACING THE DOOR SEAL .............................................................................................................. 53
11.10 SERVICE CONDUCTED BY AN AUTHORIZED SERVICE TECHNICIAN .............................................. 54
12. USE OF THE MEMORY CARD .......................................................................................................................... 55
12.1 TECHNICAL CHARACTERISTICS OF THE MEMORY CARD ............................................................... 55
12.2 READING OF MEMORY CARD DATA WITH A PC/MAC ....................................................................... 55
12.3 MINIMUM HARDWARE REQUIREMENTS FOR A PC/MAC .................................................................. 55
12.4 CONNECTING THE EXTERNAL USB CARD READER TO YOUR PC/MAC ......................................... 56
12.5 SAVED FILE ............................................................................................................................................ 56
12.6 CONTROL CODE .................................................................................................................................... 56
12.7 FILE NAMES ........................................................................................................................................... 56
12.8 DIRECTORY NAME ................................................................................................................................ 56
12.9 MEMORY CARD MANAGEMENT ........................................................................................................... 57
12.10 SAVING A FILE ....................................................................................................................................... 58
13. TROUBLESHOOTING ....................................................................................................................................... 59
14. RECYCLING / DISPOSAL INSTRUCTIONS ...................................................................................................... 60
Appendix 1
TECHNICAL CHARACTERISTICS ................................................................................................... 61
Appendix 2
STERILIZATION LOAD PREPARATION .......................................................................................... 62
Appendix 3
MAINTENANCE OF DENTAL HANDPIECES ................................................................................... 63
Appendix 4
BOWIE AND DICK TEST .................................................................................................................. 64
Appendix 5
HELIX TEST ...................................................................................................................................... 65
Appendix 6
VACUUM TEST ................................................................................................................................. 66
Appendix 7
WATER QUALITY ............................................................................................................................. 67
Appendix 8
EXAMPLE OF A CYCLE DATA REPORT ........................................................................................ 68
Appendix 9
ACCESSORIES ................................................................................................................................. 69
Appendix 10 HELIX TEST DOCUMENTATION FORM .......................................................................................... 71
b
1.
INTRODUCTION
1.1
SCOPE
The purpose of this user manual is to provide you with information about Lisa 517/522 sterilizers to
ensure:
proper installation and set-up.
optimal use.
safe and reliable operation.
compliance with regular maintenance and servicing requirements.
NOTE:
1.2
All drawings, images and texts contained in this manual are the property of the manufacturer.
All rights reserved. Even partial duplication of drawings, images or text is prohibited.
The information contained in this document is subject to change without notice.
FOREWORD
There are two types of users who may operate the sterilizer and who shall read this manual carefully:
Administrator
The head of the clinic / practice, who is legally responsible for the efficiency of the hygiene protocol in
place as well as the sterilization process. He/she is also responsible for the OPERATORS’ training and
the correct operation and maintenance of the equipment.
Operator
The person(s) who use(s) the sterilizer according to the ADMINISTRATOR’S instructions.
1.3
APPLICABLE EUROPEAN DIRECTIVES/NORMS
Lisa 517/522 sterilizers conform to the following European Directives:
Medical Device Directive 93/42/CEE for devices class IIb, in accordance with rule 15 - Appendix IX
of the above directive.
Directive 97/23/CEE (Pressure Equipment Directive – PED) for every sterilization chamber
designed and manufactured in conformity to Annex I and to the procedure described in form
D1 annex III.
Directive 2002/96/CEE (RAEE) for disposal of parts coming from electrical or electronic
parts.
The sterilizer has been developed, produced and tested in accordance with the European
Norm relative to small water steam sterilizers EN13060, and with the applicable safety
norms (see Appendix 1).
In the enclosed documents, you will find the Declaration of Conformity and a Warranty Card specific to your sterilizer.
1.4
INTENDED USE
Lisa 517/522 sterilizers are fully automated bench top steam sterilizers that generate steam using electrical
heaters.
Lisa 517/522 sterilizers are used for medical purposes, e.g. in general medical practices, dental offices, facilities for personal hygiene and beauty care and veterinary practices. They are also used for materials and
equipment that is likely to be exposed to blood or body fluids, e.g. instruments used by beauty therapists,
tattooists, body piercers and hairdressers.
The types of loads that can be sterilized with Lisa sterilizers are described in Table 1 of the reference technical norm EN 13060. These loads include solid, porous, hollow loads type A and hollow loads type B, unwrapped, single wrapped and double wrapped.
Lisa sterilizers cannot be used to sterilize liquids or pharmaceutical products.
1
1.5
SYMBOLS DISPLAYED ON THE STERILIZER
Consult this table whenever one you see one of these symbols in this manual or on the sterilizer.
ATTENTION
Where this symbol is displayed on the sterilizer, the user must refer to this document.
When shown in the user manual this symbol means ATTENTION IMPORTANT NOTES.
To disregard the instructions given in this manual, incorrect use, poor maintenance or
servicing by unauthorized personnel, clears the manufacturer of any responsibility for
warranty and any other claims.
HOT SURFACES
This symbol is displayed at the front of the sterilizer beneath the chamber door. It reminds the user to take special care to avoid burns when dealing with the sterilization
load, the sterilization chamber, the chamber door and the area around the chamber
door.
The material the sterilizer is composed of must be disposed according to the directive
2002/96/CEE.
1.6
GENERAL AND SAFETY RECOMMENDATIONS
o
o
o
o
o
o
o
o
o
o
o
The user is responsible for the proper installation, the correct use and maintenance of the sterilizer in accordance with the instructions listed in this manual. For further information call your
local service provider.
The sterilizer has not been designed for the sterilization of liquids.
The sterilizer must not be used in the presence of gas or explosive vapours.
The chamber is automatically heating to 120°C as soon as the sterilizer is switched on.
The trays and the sterilization load will be hot at the end of each cycle. Use tray or cassette
holders to empty the sterilization chamber.
Do not exceed the maximum load weight limits as specified in this manual (see § 7.1)
Do not remove the name plate or any label from the sterilizer.
To avoid electrical short circuits, do not pour water or any other liquid over the sterilizer.
Switch off the sterilizer and unplug the mains cable before inspecting, carrying out maintenance
or servicing the sterilizer.
Repairs, maintenance or service must be carried out by authorized W&H service technicians
only with the use of original spare parts.
In case of transport:
- Drain both water tanks completely (§ 5.5).
- Allow the sterilization chamber to cool down.
- Use original or appropriate packaging.
Not observing the instructions as specified in this manual can lead to unsafe operation for the user.
2
2.
2.1
UNPACKING
UNPACKING THE STERILIZER
If the sterilizer had been kept in a place with temperature and
humidity different from the installation location, wait for an appropriate time before installing and switching ON the sterilizer. Sterilizers arriving from cold locations could contain moisture, affecting
the electrical parts and it could lead to unsafe operation for the
user if switched ON immediately.
The sterilizer must be removed from the box and transported by
two people.
Lisa 517 40 kg
Total weight:
Lisa 522 50 kg
NOTE:
2.2
Check the external condition of the box and the sterilizer. In case of any
damages, immediately contact your dealer or the shipping agent that has
carried out the transport.
STANDARD ACCESSORIES
Following accessories are supplied together with the sterilizer:
ACCESSORIES PLACED INSIDE THE STERILIZATION CHAMBER
Accessory
Description
Tray
Perforated anodized aluminum tray
Reversible rack
Stainless steel rack to accommodate 5 trays or 3
cassettes.
Optional racks available (see Appendix 8). For more
information contact your dealer.
Quantity
5
1
Tray holder
Tray holder for removing trays from the sterilization
chamber.
1
Drain tube
Transparent drain tube with quick connector
1
Mains cable
Length = 2 meters
1
Funnel
Funnel to fill the clean water tank.
1
Wall spacer
Spacer to keep distance between wall and steril.
2
DOCUMENTS PLACED INSIDE THE PACKAGE
Declaration of conformity CE
Sterilization chamber:
1
Sterilizer:
1
User manual
Current user manual
1
Warranty card
Warranty card
1
Works Test Report
Norm EN 13060: small steam sterilizers.
1
ACCESSORIES PLACED INSIDE THE PACKAGE
Memory card USB reader
External memory card reader
1
Memory card
Reads and saves cycle data
1
3
3.
3.1
UNIT DESCRIPTION
FRONT VIEW
Door seal
Water tank cover
Sliding cover for
manual filling of
the clean water
tank
Chamber
door
Sterilization
chamber
Touch- screen
Door pin
Service door
Dust filter
3.2
SERVICE DOOR
Bacteriological filter
Main switch
Quick connector for
manual draining of
used water tank
Quick connector for
manual draining of
clean water tank
4
Connection to unlock
the chamber door (service technicians only)
Connection for the
Air Detector Test
Device (optional)
Memory card slot
3.3
REAR VIEW
Parallel port
(printer)
Circuit breaker
(manual reset)
Male serial port
Female serial port
Mains plug socket
Safety valve cover
Mains cable guide
Test connection
Condenser vent
Plug for an external
water supply system
Air filter
Fitting for an external
water supply system
D1
D3
D2
D4
Fitting for continuous
draining of used water
5
3.4
DESCRIPTION OF THE INTERNAL WATER TANKS
The sterilizer is equipped with two independent water tanks, one for clean water and one for used water
(capacity of 3.5 litres each).
The tank on the right side is called "clean water tank" and has to be filled with distilled or demineralized
water required for the sterilization process. It is fitted with a minimum (0.6l) and a maximum (3.5l) water
level sensor. The tank can be filled manually through the tank hole on the top of the sterilizer or automatically with an external water supply system (Dem 32 or Osmo) connected to point D2 at the back of the sterilizer (see § 4.5.1).
Use the quick connector behind the service door (left/blue) to drain the clean water tank for cleaning purposes (see chapter on maintenance).
The tank on the left side is called "used water tank" and contains the used water collected at the end of
each sterilization cycle. It is fitted with a maximum water level sensor (3.5l).
Use the quick connector behind the service door (right/grey) to drain the used water tank (see chapter on
maintenance).
The used water tank can also be drained automatically by connecting a drain tube to the D4 fitting located
at the back of the sterilizer (see § 4.6).
Vent
Clean water tank
Used water tank
Water level sensors
Water inlet for manual filling of
clean water tank
Quick connector for
manual draining of
clean water tank
Fittings for automatic filling/draining of tanks
Quick connector for manual draining of used
water tank
NOTE:
6
The water consumption per sterilization cycle varies depending on the type and weight of the
sterilization load. The capacity of the clean water tank is sufficient to run 8 - 12 sterilization
cycles.
3.5
CHAMBER RACK
Insert the rack into the sterilization chamber, align it
at the center/bottom of the chamber and push it
gently into position until it clicks.
The chamber rack is reversible and can be used
for:
5 trays horizontally or 3 cassettes vertically;
or, if inserted in a 90° degree rotated position,
3 trays or 3 cassettes horizontally.
3.6
USABLE SPACE IN THE CHAMBER
The chamber usable space is the maximum volume of the
chamber for accommodating a sterilization load. This volume is
equivalent to a pipe with the following dimensions:
Lisa 517
195 x 195 x 297mm (WxHxD); equal to the volume of 11.5 litres
H
W
A
D
Ritor
no
alla
sch
er
mata
pre
ceden
te
Lisa 522
195 x 195 x 390mm (WxHxD); equal to the volume of 15 litres
The capacity/volume is identical for all sterilization cycles and
types of load.
7
4.
4.1
INSTALLATION
SETUP
The sterilizer has been calibrated and intensively tested in the factory prior to shipping. It does not require
any calibration during installation.
Observe the following environmental conditions:
Working temperature range: from +5°C to +40°C / relative humidity: 0 - 90%
Storage temperature range: from -20°C to +60°C / relative humidity: 0 - 90% (empty tanks)
Install the sterilizer as outlined below:
Place the sterilizer on a flat and level surface.
Do not place the sterilizer so that it is difficult to open the service
door and operate on the controls in it (main switch, microbiological
filter, drains)
The maximum weight of the sterilizer with a full clean water tank
and the chamber fully loaded is:
52 kg (Lisa 517)
63 kg (Lisa 522)
Leave a gap of 50mm in the back and 10mm on each side of the
sterilizer to ensure adequate ventilation.
Mount the supplied wall spacers at the back of the sterilizer
(see image to the right).
Do not place the sterilizer near a sink or in a location where it is
likely to be splashed with water - danger of electric short circuit!
Install the sterilizer in a well-ventilated room.
Keep the sterilizer away from all sources of heat.
4.1.1
Securing the sterilizer with a safety bracket
If the bench on which the sterilizer is installed is small, there is a
risk of the sterilizer tilting when the chamber door is opened and
leaned upon.
Use the safety bracket (optional; see Appendix 9) to avoid tilting.
- Move the two front feet in the rear position.
- Drill two holes on the installation surface and fix the bracket
with the supplied screws.
Wall
Screws Ø4,8x22
113
Minimum distance
(millimeters)
40
2 holes Ø3x20
Refer to safety bracket installation procedures for further details.
Position the sterilizer on the bench with one of the rear feet inserted in the safety bracket.
8
4.2
ELECTRICAL POWER SUPPLY
The electrical power supply of the sterilizer must comply with all applicable standards in the country of use.
The following characteristics are required:
- Single - phase 200 - 240 VAC ±10%, 50/60 Hz, 10 A, on a
dedicated circuit.
- Installation category / mains overload category = II
- 10 A differential circuit breaker with a sensitivity of 30 mA.
The circuit breaker must be a certified type according to applicable norms.
- Maximum power consumption of the sterilizer is 2,000 2,400W (10 A)
- A grounded connection is essential.
Check that the voltage specified on the name plate located on the backside of the
sterilizer corresponds to the supplied mains voltage.
The overall electrical safety of the sterilizer is guaranteed only if the mains voltage
supply is properly grounded according to all applicable norms.
If unclear, have the electrical installation checked by a qualified electrician.
Do not plug other equipment into the same socket/circuit.
Do not bend or twist the mains cable.
Only use the original mains cable as supplied with the sterilizer.
Do not use cable extensions.
4.3
PRINTER (optional)
We recommend the use of LisaPrint (conforms to the IEC 61010-1 norm) as it has
been tested for compatibility with the sterilizer and its software.
The use of printers other than the ones listed in the relevant printer setup menu (see
6.1.3) clears the manufacturer of any responsibility for warranty or any other claims.
- Connect the printer cable to the 25-pin parallel port socket at the back
of the sterilizer. Cable length should not exceed 2 meters.
- Connect the printer mains cable.
- Switch ON the printer.
- Select the printer type (§ 6.1.3). LisaPrint is the default setting
(Print-p).
All necessary data to document sterilization cycles is automatically printed
(for details see Appendix 8).
NOTE:
Lisa 517/522 sterilizers offer the option to digitally save cycle data on removable memory cards.
9
4.4
LISAWARE - CONNECTING THE STERILIZER TO A COMPUTER (optional)
Connect up to four Lisa 517/522 sterilizers to a computer or computer network with LisaWare, a computer
software that allows automatic saving of cycle data on a computer and the remote monitoring of the cycle
progress on the computer screen.
Sterilizers can be connected to a computer in two ways, either via a LAN connection using a MOXA ethernet to serial adaptor, or via a serial connection.
4.4.1
LAN connection
W&H recommend using the MOXA NPort 5110 which has been tested and is compatible with the Lisa sterilizer and its software.
The use of other ethernet to serial adaptors removes all responsibility from the manufacturer in regards to the correct functioning of the system, the warranty and any
other claims.
-
Your sterilizer features two serial ports in the back: male and female; either port can be used for
data transfer. Switch on the sterilizer, access the setup menu, enter the “RSDATA port selection”
option and select one of the two available serial ports for data transfer (see 6.1.17).
- Scroll to the “Connection to PC/Log” option in the setup menu and select and confirm “yes” (see
6.1.16).
- Please refer to the MOXA configuration sheet for instructions on how to configure your MOXA
NPort 5110 to your network.
- Once you have configured your MOXA, use one of the supplied serial cables (F-F and F-M) to
connect the MOXA to the serial port you selected for data transfer.
- Connect the MOXA to the LAN using an ethernet cable (or if connecting directly to the computer
use a cross-wire cable).
- Use the supplied cable to connect the MOXA to the mains power supply.
For further information, please refer to the “Connection Lisa to LAN or PC” quick-start guide.
W&H does not accept any responsibility should the MOXA interfere with the normal
functioning of your network.
4.4.2
Serial connection
-
Your sterilizer features two serial ports in the back: male and female; either port can be used for
data transfer. Switch on the sterilizer, access the setup menu, enter the “RSDATA port selection”
option and select one of the two available serial ports for data transfer (see 6.1.17).
- Scroll to the “Connection to PC/Log” option in the setup menu and select and confirm “yes” (see
6.1.16).
- Use one of the supplied serial cables (F-F and F-M) to connect the sterilizer (from the selected
serial port) directly to the serial port on your computer.
For further information, please refer to the “Connection Lisa to LAN or PC” quick-start guide.
10
4.5
DEMINERALIZER (optional)
W&H Sterilization offers external water supply systems for automated supply of demineralized water to the
sterilizer(s) (Dem32 or Osmo).
Once installed, the clean water tank no longer needs
to be filled manually but will be filled automatically
with demineralized water. The Dem32/Osmo features
WATER
SUPPLY
resin cartridges to remove minerals from city water to
assure a constant supply of good quality water for the
sterilization process.
4.5.1
Connecting an external water
supply system (demineralizer)
D2 = filling
To install a Dem32/Osmo water supply system, an
interface cable and the fittings D2 and D4 located at
the back of the sterilizer are used.
For more information, refer to the Dem32/Osmo user
Interface
cable
4.6
4.6.1
manuals.
CONTINUOUS DRAINING (optional)
Connecting the drain tube
DRAIN
The sterilizer can be connected to a drain (or simply to a sink)
for continuous draining of the used water tank.
- Unscrew the plug from the D4 fitting at the back of the sterilizer.
- Install the 1/8” barb fitting and the drain tube from the kit
and route the tube to a drain or sink (kit ordering number:
G0053060). If unclear, have the installation checked by a
qualified plumber.
D4 = draining
The drain tube must not be longer than 5
meters.
The draining point must be at least 20cm
below the surface on which the sterilizer is
placed.
For further information, refer to the Dem32/Osmo user manuals.
11
5.
5.1
GETTING STARTED
THE USER INTERFACE
To power the sterilizer press the main switch located behind the service
door (see image to the left).
When the sterilizer is switched ON, the chamber automatically heats to 120°C.
This process (pre-heating) takes approximately 10 minutes.
If a sterilization cycle is initiated during the pre-heating
phase, it will start automatically once the pre-heating temperature is achieved.
Once the sterilizer is switched on, the following screen appears:
Sleep mode
Menu option
Available cycles
Current date
Current time
Selection
confirmation
Cycle selection
Cycle counter
To run a sterilization cycle, place the load in the sterilization chamber and close the chamber door. Select
a cycle by pressing the “Cycle selection” icon and confirm the selection by pressing the “Selection confirmation” icon.
Start cycle
A screen will inform you about the maximum load weight limits for the cycle you selected. Initiate the cycle
by pressing the “Start cycle” icon.
12
5.2
INITIAL WARNINGS AND SLEEP MODE
This message will appear if the sterilizer is switched on and the clean water tank is empty. Fill the clean
water tank with distilled or demineralized water (see § 5.4).
NOTE:
If this message is displayed it is not possible to initiate a sterilization cycle. The message disappears automatically once the clean water tank is filled.
If the sterilizer is not used for a certain programmable time period, it will automatically switch to “Sleep
mode” to conserve energy (programmable time-out; default 1 hour; see § 6.1.2). Press the “Sleep mode”
icon to get back to the main menu.
Sleep mode
5.3
DATE-CLOCK SETTING
To properly save or print cycle data on a memory card or on a printout, the internal sterilizer time and date
has to be set since these parameters are included in the sterilization cycle data report. Please refer to §
6.1.9 for details on how to properly set the sterilizer date and time.
13
5.4
5.4.1
FILLING THE CLEAN WATER TANK
Manual filling
Use only high quality distilled or demineralized water (see Appendix 7).
Slide the tank cover to the right to access the clean
water tank inlet.
Remove the cap (1) from the tank inlet.
Insert the funnel and fill the clean water tank with
app. 3.5 litres of distilled or demineralized water.
Once the clean water tank is almost full, an audible
tone will sound; stop filling.
Place the cap (1) to close the tank.
Slide the tank cover back into its original position.
Drain the used water tank (see § 5.5).
The water level in the clean water tank decreases during every sterilization cycle, while the water level in
the used water tank is rising. The sterilizer is equipped with an internal water conductivity sensor that constantly monitors the water quality in regards to mineral content. Should the mineral content go beyond a
maximum threshold (conductivity >15µS/cm), a warning message is displayed on the screen.
Every time you fill the clean water tank, drain the used water tank (see § 5.5).
5.4.2
Automated water supply (optional)
If an automated water supply system is connected to the sterilizer (see §
4.5), the clean water tank gets automatically filled once the water level drops
below the minimum level.
An internal water conductivity sensor constantly monitors the water quality in
regards to mineral content. Should the mineral content go beyond a maximum threshold (>15µS/cm conductivity as defined by the European Norm
EN 13060), a warning message is displayed on the screen (see screenshot
to the left).
Water of low quality with high mineral contents can impair the sterilization process
and seriously damage the internal components of the sterilizer. Damages caused by
water of poor quality will not be covered by the manufacturer’s warranty. Once the non
conform water message is displayed, check the water source (refer to the water supply
system user manual; replace resin cartridges etc.). In case distilled or demineralized
water is purchased, switch to a brand of better quality.
14
5.5
DRAINING THE USED WATER TANK
When the waste water in the used water tank reaches the maximum level, the
following message is displayed:
The message will disappear once the used water tank got drained. Keep
draining the tank until it is completely empty.
5.5.1
Manual draining
Open the service door at the front of the sterilizer.
Insert the drain tube into the quick connector for the
used water (grey connector / right).
Drain the used water tank until it is completely empty.
Press the push-button on top of the quick connector to
dislodge the drain tube.
Never reuse water from the used water tank!
5.5.2
Continuous draining
If the permanent drain tube for automated draining of the used water is mounted, the used water tank gets
drained automatically. For more information see § 4.6.
If the sterilizer is not used for more than 3 days, both water tanks should be completely
drained in order to avoid algae growth or any other deposits.
5.6
5.6.1
MEMORY CARD
Inserting / removing the memory card
Lisa 517/522 sterilizers are equipped with a digital cycle data recording
system. Cycle data are written and saved on removable/rewritable memory cards.
- Insert the memory card into the dedicated slot behind the service door
until it clicks into its final position. Ensure that the flat corner of the
card points to the top/right (see image to the right).
- Periodically remove the memory card to download cycle data to a
computer.
- To remove the memory card, slighty push it in and pull it out gently.
For further instructions on the use of the memory card, see §12.
15
6.
PROGRAMMING
Lisa 517/522 sterilizers allow the user to program a number of different features. The following section
shows step by step how each of these features can be programmed.
Press the menu icon to view the list of available options.
The available menu options are shown
below:
Menu
6.1 SETUP MENU
The Setup menu permits to set the following options:
§ 6.1.1 – Language
§ 6.1.2 – Sleep mode
§ 6.1.3 – Printer
§ 6.1.4 – Label printer *
§ 6.1.5 – Automatic printing *
Exit and return to
higher menu level
§ 6.1.6 – Manual printing *
§ 6.1.7 – Storage time *
§ 6.1.8 – User name
Confirm and return to previous
§ 6.1.9 – Date-Clock setting
menu
§ 6.1.10 – Date format
§ 6.1.11 – Clock format
§ 6.1.12 – Display contrast
§ 6.1.13 – Display backlight
§ 6.1.14 – Acoustic tones
§ 6.1.15 – Night cycle shortcut
§ 6.1.16 – Connection to PC/Log
§ 6.1.17 – RSDATA port selection
Scroll up
Current
selection
Scroll-down
* The sub-menus related to label printing are only
available when the label printer LisaSafe is connected.
6.1.1
Language
Scroll up
Use this menu to select the user interface lanExit and
return to higher
guage.
menu level
Confirm and return to
previous menu
16
Current
selection
Scroll down
6.1.2
Sleep mode
In “Sleep mode” the sterilizer reduces the
power consumption to a minimum. The sterilizer will switch to sleep mode whenever it is
idling without being used. Use this menu to
program the time before the sterilizer automatically switches to sleep mode.
The time range is from 0 (never in sleep mode)
to 8 hours. The factory setting is 1 hour.The
time can be set in fixed increments of 10 minutes.
6.1.3
Printer
Use this menu if you want to connect a printer
for cycle data recording. Select the printer by
using the scroll icons, press “Confirm” to save
the configuration. For more information on
connecting a printer to your sterilizer, see §
4.3.
6.1.4
Exit and return to
higher menu level
Confirm and return to
previous menu
Exit and return to
higher menu
level
Increase
time
Decrease
time
Scroll up
Current
selection
Confirm and return
to previous menu
Scroll down
Label printer (available only when a LisaSafe label printer is connected)
6.1.5
Automatic printing (available only when a LisaSafe label printer is connected)
6.1.6
Manual printing (available only when a LisaSafe label printer is connected)
6.1.7
Storage time/weeks (available only when a LisaSafe label printer is connected)
6.1.8
User name
Use this menu to program the user or the office name. The name will be included in the
cycle data report. Select a character by pressing the ”Increment” or “Decrement” icons.
Press the “Move next” icon to move to the next
position. When the setting is completed, press
the “Confirm” icon.
Exit and return to
higher menu level
User
or office name
Confirm and return
to previous menu
Increment
Move next
Decrement
Move previous
6.1.9
Date-Clock setting
Use this menu to set the internal time and date
of the sterilizer. It is important to set these parameters as they are included in the cycle data
report.
Select a character by pressing the ”Increment”
or “Decrement” icons. Press the “Move next”
icon to go to the next position. When the setting is completed, press the “Confirm” icon.
Exit and return to
higher menu level
Date
Increment
Time
Move next
Confirm and return
to previous menu
Decrement
17
6.1.10
Date format
Use this menu to change the date format.
Press the “Scroll up” and “Scroll down” icons
to select the format. Press the “Confirm” icon
to save the selection.
Exit and return to
higher menu level
Scroll up
Confirm and return
to previous screen
Scroll down
6.1.11
Clock format
Use this menu to change the clock format.
Press the “Scroll up” and “Scroll down” icons
to select the format. Press the “Confirm” icon
to save the selection.
Exit and return to
higher menu level
Scroll up
Confirm and return
to previous screen
Scroll down
6.1.12
Display contrast
Use this menu to change the screen contrast
for a better visualization in regards to the surrounding environment. Press the “Increase
contrast” and “Decrease contrast” icons to adjust the contrast. Press the “Confirm” icon to
save the selection.
6.1.13
Display backlight
Use this menu to adjust the screen backlight.
Press the “Increment” and “Decrement” icons
to change the setting. Press the “Confirm” icon
to save the selection.
Exit and return to
higher menu level
Increase
Confirm and return
to previous screen
Decrease
Exit and return to
higher menu level
Increase
Confirm and return
to previous screen
Decrease
6.1.14
Acoustic tones
Use this menu to set the amount of audible
tones the sterilizer is generating for various
procedures:
“All”: All actions come with audible tones.
“Reduced”: Most actions come with audible
tones.
“Minimum”: Only critical actions come with
audible tones (e.g., alarms, end of cycle,
etc.).
Press the “Scroll up” and “Scroll down” icons
to select the setting. Press the “Confirm“ icon
to save the setting.
18
Exit and return to
higher menu level
Scroll up
Confirm and return
to previous screen
Scroll
down
6.1.15
Night cycle shortcut
If you frequently use the delayed cycle start option (see § 6.2) you can activate an icon on the main screen
(cycle selection screen) that will serve as a shortcut to the delayed cycle start submenu.
Select the “Night cycle shortcut” option by
pressing ”Scroll up” and “Scroll down”.
Press “Confirm” to enter the option.
Exit and return to
higher menu level
Scroll up
Selection
confirmation
Scroll down
Select “Yes” using “Scroll up” and “Scroll
down” and press “Confirm” to save the
setting.
Exit and return to
higher menu level
Scroll up
Confirm and return
to previous screen
Scroll down
Once you have selected the shortcut option, a shortcut icon will appear on the
main screen (cycle selection screen; see
picture to the right).
Note: The shortcut icon will only appear if
you have used the delayed cycle start
function at least once in the past.
Whenever you wish to use the delayed
cycle start function, press the shortcut to
night cycle icon. You will access a screen
showing your most recent settings for delayed cycle start cycle type and time/date.
Note: The suggested date will be set by
default to either the current day or the
next day, depending on your past programming pattern.
If you wish to modify any of the default
settings, press the “Settings” icon. This
will send you to the delayed cycle selection screens. Please refer to § 6.2 for further information.
To launch the delayed cycle, press the
“start cycle” icon.
“Shortcut to
night cycle”
Most recent
cycle type
Current date or
date of next day
START Cycle
icon to launch
delayed cycle
Time of most
recent cycle
SETTINGS
icon; press to
enter delayed
cycle selection
screens
19
6.1.16
Connection to PC/Log
Use this menu if you want your sterilizer to communicate with a computer in conjunction with the LisaWare
software package. For further details please see § 4.4.
Select the “Connection to PC/Log?” option by pressing the “Scroll up” and “Scroll
down” icons. Press “Confirm” to enter the
option.
Exit and return to
higher menu level
Scroll up
Selection
confirmation
Scroll down
Select “Yes” using the “Scroll up” and
“Scroll down” icons and press the “Confirm” icon to save the setting.
Exit and return to
higher menu level
Scroll up
Confirm and return
to previous screen
Scroll down
6.1.17
RSDATA port selection
Use this menu to allocate one of the rear serial ports for data transfer to your computer in conjunction with
the LisaWare software package (see § 4.4).
Select the “RSDATA port selection” option by pressing the “Scroll up” and “Scroll
down” icons. Press the “Selection confirmation” icon to enter the option.
Exit and return to
higher menu level
Scroll up
Selection
confirmation
Scroll down
There are two serial ports for data transfer fitted in the back of the sterilizer. Looking at the sterilizer from the back, the
serial port on the right side is of a female
type (RS232), whereas the port on the left
is of a male type (RS232). Any of the two
ports can be used for data transfer; the
LisaWare package includes both male
and female cables. Select the serial port
you wish to allocate for data transfer using the “Scroll up” and “Scroll down” icons
and press the “Confirm” icon to save the
setting.
20
Scroll up
Exit and return to
higher menu level
Selection
confirmation
Scroll down
6.2
TEST CYCLES
Use this menu to run a variety of test cycles that
might be mandatory in your country. Press the
"Menu" icon on the main screen and select
"Test cycles" from the menu (see § 6).
Select the Test cycle by pressing the ”Scroll
up” and “Scroll down” icons and initiate the
cycle by pressing the "Selection confirmation" icon. For more information on test
cycles see appendices 3-5.
Exit and return
to higher
menu level
Scroll up
Selection
confirmation
Scroll down
21
6.3
DELAYED CYCLE START
Use this menu to delay the start of one or up to three consecutive cycles (e.g., if you want to load the sterilizer in the evening and run a Vacuum Test followed by Bowie and Dick Test or a standard sterilization
cycle early the next morning before office hours). It is possible to set both the date and the time in which
the selected cycle(s) will start. Place the test or sterilization load in the chamber, close the chamber door,
press the "Menu" icon on the main screen and select "Delayed cycle start" from the menu. If this option is
frequently used, there is the possibility to add a shortcut icon on the main screen (cycle selection screen;
see § 6.1.15).
Once you entered the “Delayed cycle start” opScroll up
Exit and retion, you will see a list of all available steriliza2turn to higher
tion and test cycles. Select the cycle(s) you
2 menu level
want to start delayed by pressing the “Scroll
up” and “Scroll down” icons; use the “confirm
Scroll down
Confirm setselection” icon to select, de-select and sort the
tings and enter
cycles of your choice.
next screen
Once set correctly, press the “confirm settings”
Confirm selection
icon to go to the next screen.
Set the date and time of the delayed cycle start
by pressing the “Increment” or “Decrement”
icons. Press the “Move next” icon to go to the
next character. When the setting is completed,
press the “Confirm” icon to go to the next
screen.
Return to previous screen
Increment
Set date
Confirm settings and enter
next screen
Set time
Decrement
Move next
On this screen the selected cycle(s) is/are
shown. Press the "Cycle start" icon to launch
the delayed cycle.
Return to
previous
screen
Cycle
start
Cycle
counter
Manual stop
The current and the set delayed date and time
appear on the screen indicating when the delayed cycle(s) will start.
Current date
and time
Delayed cycle
date and time
22
6.4
CYCLE HISTORY
Use this menu to view cycle data of the most recent
30 sterilization and/or test cycles. Cycle data is
recorded on the main CPU board on a “first in – first
out” basis.
Press the “Menu” icon on the main screen and select “Cycle history” from the menu (see § 6).
Return to previous screen
Scroll up
Saved cycles
Selection
confirmation
Scroll down
Return to
previous
screen
Scroll up
Use the “Scroll up” and ”Scroll down” icons to select a cycle you want to view. Press “Confirm” to
view further details of the selected cycle:
Print cycle
Scroll down
It is possible to print or save this data by selecting the appropriate icons:
prints the cycle report (only if a printer is connected to the sterilizer; see § 4.3 and 6.1.3)
saves the cycle report on the memory card
prints cycle labels (only if a LisaSafe label printer is connected to the sterilizer; see § 6.1.4)
If you have several accessories connected to your sterilizer, more icons
will be available (see aside).
If more than two options are active, a
selection key
appears to allow
you to select the desired icon and
action.
23
6.5
MAINTENANCE
Certain consumables have to be replaced periodically to guarantee a faultless operation of the sterilizer.
Display messages will inform you whenever it is time to replace one of those components (see § 8).
Press the "Menu" icon on the main screen and select "Maintenance" from the submenu (see § 6). Use
this menu to view the number of cycles remaining before it is time to replace the:
bacteriological filter (every 400 cycles)
dust filter (every 400 cycles)
door seal (every 800 cycles)
or perform a general service by a qualified technician (every 4000 cycles)
The 4 counters decrease in value after each cycle. When one of the counters reaches 0, the corresponding message appears on the touch-screen (see § 8).
In case a consumable gets replaced before the respective counter has reached 0, the counter has to be
Scroll up
reset manually:
Select the counter you wish to reset by pressing
the ”Scroll up” and “Scroll down” icons.
Reset the counter by pressing the “Confirm reset” icon.
Confirm by selecting "Yes" or "No" from the
maintenance screen shown aside.
Confirm reset
Scroll
down
Yes
No
To guarantee an efficient sterilization process and the correct functioning of the sterilizer, we strongly recommend to follow the maintenance program (see § 11.1).
6.6
SERVICE
This menu is used for service and diagnostic operations. It can be accessed by authorized service technicians only.
6.7 UTILITY
Use this menu to view the sterilizer system information and to format the
memory card. Press the “Menu” icon on the main screen and select “Utility” from the menu (see § 6).
24
6.7.1
System info
Use this menu to view the sterilizer system information.
Model
Serial Number
Firmware revision
Loader revision
Power FW revision
6.7.2
Formatting the memory card
Use this menu to format your memory card in case you want to erase all the data on the card. Press the
“Menu” icon on the main screen and select “Utility” from the menu (see § 6). Press “Format MMC” to initiate the formatting.
The system first verifies the card.
Next you will see this screen asking if
you want to format the card. Press
"Confirm" to proceed with the formatting or "Cancel" to exit the formatting
menu.
If you confirm to proceed with formatting, all data will be lost on the
card. Press “Cancel” to exit the
formatting menu.
Once the formatting is completed,
Confirm
the card is ready to be used
6.8
Confirm
Cancel
Cancel
USER AUTHENTICATION
W&H Lisa 517/522 sterilizers, in combination with the optional LisaSafe package for label printing, provide
an ultra-safe traceability concept in an extremely user-friendly way.
They provide the following options, all separately selectable:
Management of multiple users by the Administrator (dentist)
Identification via user name and saving of the user who has started the cycle
Password-protected cycle start once the user has been identified
Identification via user name and saving of the user who has released the load
Password-protected load release once the user has been identified
Printing of bar-code labels containing the name of the user who has released the load
Inhibition of label printing if the cycle has not completed successfully (alarm, cycle interruption etc.)
so as to avoid all human error
Easy management and access to all traceability options directly from the sterilizer touch-screen.
25
6.9
FUNCTIONS AVAILABLE FOR THE ADMINISTRATOR
6.9.1
Access the administrator functions
To access the ADMINISTRATOR functions:
1) Press the “Menu” icon on the main screen that appears when the unit is switched ON.
2) Scroll the options until the “User authentication" option is highlighted and confirm.
Abort and return to
previous screen
Scroll up
Confirm and go
ahead
Scroll down
3) A list of users will be displayed: scroll the list until the ADMINISTRATOR is highlighted and confirm.
Scroll up
Abort and return
to previous
screen
Confirm and go
ahead
Scroll
down
4) Enter the secret password to gain access to the ADMINISTRATOR functions.
(The default password for the Administrator (and for any new user) is 0000.)
Abort and return
to previous
screen
Move to the previous position
Erase the last entry
26
5) Select the desired option using the scroll buttons and confirm your selection:
You can choose the following options:
1) Modify a user name
Abort and return
to previous
2) Change my password
screen
3) Reset a user’s passwords to the default value
(0000)
4) Delete a user
Confirm the choice
5) Add a new user
and go ahead
6) Define the user identification options
6.9.2
Scroll up
Scroll
down
Modifying a user name
1) Scroll the menu options and select the “Modify user name” option.
Abort and return
to previous
screen
Scroll up
Confirm the choice
and go ahead
Scroll
down
2) Select the name of the user to be modified and confirm.
Abort and return
to previous
screen
Scroll up
Confirm the choice
Scroll down
3) Select the letter(s) to be modified using the PREVIOUS and NEXT position buttons. Use the SCROLL
UP and SCROLL DOWN buttons to select the correct letter.
Once finished, confirm the changes: this will save the changes and exit the menu.
Abort and return
to previous
screen
Scroll
letters up
The letter being
changed is highlighted
Confirm the
changes
Scroll
letters
down
Move to
previous
position
Move to
next
position
27
6.9.3
Changing the administrator’s password
The default password for the Administrator (and for any new user) is 0000.
To change the Administrator’s password proceed as follows:
1) Scroll through the menu options and select the “Change my password” option and confirm.
Abort and return
to previous
screen
Scroll up
Confirm the choice
Scroll down
2) Enter the new four-digit password.
WARNING!
The password is saved as soon as
the fourth digit has been entered.
If you are unsure of the sequence
you have entered, DO NOT EXIT
THE FUNCTION and repeat the procedure.
Abort and return
to previous
screen
Move to the previous position
Erase the last entry
3) Press the confirmation button to save and exit the function.
Press to continue
28
6.9.4
Resetting a user’s password to the default value (0000)
Use this function if a user has lost or forgotten his/her own password: it can be reset to "0000" so that the
user can then enter with “0000” and save a new valid password.
To reset a user’s password proceed as follows:
1) Scroll through the menu and select the “Reset password (0000)” option and confirm.
Abort and return
to previous
screen
Scroll up
Confirm the choice
Scroll down
2) Select the name of the user who needs a new password and confirm.
Abort and return
to previous
screen
Scroll up
Confirm the choice
Scroll down
3) The old password has been deleted and the new password is “0000”. Press the confirmation button to
exit the sub-menu.
Press to continue
NOTE
The user is now able to set a new password. See section 6.10
29
6.9.5
Deleting a user
To delete the name of a user who no longer uses the sterilizer, proceed as follows:
1) Scroll through the menu options and select the “Delete user” option.
Abort and return
to previous
screen
Scroll up
Confirm the choice
Scroll down
2) Select the user to be deleted and confirm
Abort and return
to previous
screen
Scroll up
Confirm the choice
Scroll down
3) Confirm the operation
Abort and return
to previous
screen
Confirm deleting
30
6.9.6
Adding a new user
This function allows to create a new user who is permitted to operate the sterilizer.
1) Scroll through the menu options, select the “Add new user” option and confirm.
Abort and return
to previous
screen
Scroll up
Confirm the choice
Scroll down
2) Enter the user name using the UP and DOWN buttons to select the correct letter, and PREVIOUS and
NEXT buttons to move along the character positions.
Once entered correctly, confirm the changes.
Abort and return
to previous
screen
ATTENTION!
The new user will be created as
soon as the confirmation button
is pressed.
Scroll
letters up
The letter being
introduced is
highlighted
Scroll
letters
down
Confirm the name
Move to previous position
Move to next position
or add a space
31
6.9.7
Setting the user identification options for all users
Depending on the organization of the practice and the traceability requirements, the ADMINISTRATOR
can set the following options:
- Identification and saving of the operator who has started the cycle;
- Password-protected cycle start once the operator has been identified;
- Identification and saving of the operator who has released the load;
- Password-protected load release and label printing once the operator has been identified.
1) Scroll through the menu options and select “User Identification options”.
Abort and return
to previous
screen
Scroll up
Confirm the choice
Scroll down
2) The following screen will appear. Use the UP and DOWN buttons, and activate / deactivate each option
with the TICK button. The “” symbol confirms that the option has been activated.
Accept and return
to previous screen
Scroll the
list up
Tick – untick the
highlighted item
Scroll the
list down
The following options can be activated:
- User name at cycle start:
When the cycle has been selected and is started, the user will be asked to identify him/herself. The operator’s name will be saved and included in the cycle report.
If this option has been activated and no operator is identified, it will not be possible to start the cycle.
- Password at cycle start:
Once the user has been identified, he/she will be asked to enter the secret password.
If the password is entered incorrectly, it will not be possible to start the cycle.
- User name at load release:
When the door is opened at the end of the cycle, the user will be asked to identify him/herself to release
the load. The user name will be saved, included in the cycle report and printed on the load identification labels.
If this option has been activated and no user is identified, no labels will be printed.
- Password at load release:
Once the user has been identified, he/she will be asked to enter the secret password
If the password is entered incorrectly, no labels will be printed.
- The use of passwords can only be activated if the relevant identification option has
been activated too.
NOTES
- The selected user identification options apply to all operators as well as to the administrator.
32
6.10 FUNCTIONS AVAILABLE TO THE OPERATOR(S): PASSWORD
MODIFICATION
Proceed as follows:
1) Press the “Menu” icon on the main screen that appears when the unit is switched ON.
2) Scroll the menu options and select the “User authentication” option.
Abort and return
to previous screen
Scroll up
Confirm and go ahead
Scroll down
3) A list of users will be displayed: scroll through the list until your name is highlighted, then press the confirmation button.
Abort and return
to previous
screen
Confirm and
go ahead
Scroll up
Scroll
down
4) You will then be asked to enter your OLD password. If you are inserting a password for the first time, or
after it has been reset to the default, the password is 0000
Abort and return
to previous
screen
Move to the
previous position
Erase the last entry
33
5) The “Change my password” function is now available: select it by pressing the confirmation button.
Abort and return
to previous
screen
Confirm the choice
6) The password keypad appears. Enter your NEW four-digit password.
WARNING!
The password is saved as soon as
the fourth digit has been entered.
If you are unsure of the sequence
you have entered, DO NOT EXIT THE
FUNCTION and repeat the procedure.
Abort and return
to previous
screen
Move to the
previous position
Erase the last entry
7) The following screen will appear: press the confirmation button to continue.
Press to continue
34
6.11 STARTING AND ENDING A STERILIZATION CYCLE
WITH IDENTIFICATION OF THE USER
NOTE
6.11.1
The instructions in this chapter are valid only if the “User Authentication” option is activated. See § 6.8
Starting a sterilization cycle
The steps required to start a sterilization cycle are basically the same as described in §7.1.1, with the following changes:
- After selecting and confirming the cycle, if the “Identification at cycle start” option has been activated, a
list of all the authorized users will appear.
Scroll through the list until your name is highlighted and confirm.
Scroll up
Abort and return
to previous
screen
Confirm and
go ahead
Scroll
down
- If the “Password at cycle start” option has been activated, the password keypad will appear.
Enter your password to start the sterilization cycle.
The name of the user that launched the cycle will be saved.
Abort and return
to previous
screen
Move to the previous position
Erase the last entry
35
6.11.2
End of a sterilization cycle
At the end of a cycle when the door is opened, if the “User name at load release” option has been activated, a list of all authorized users will appear.
Scroll through the list until your name is highlighted and confirm.
Scroll up
Abort and return
to previous
screen
Confirm and
go ahead
Scroll
down
- If the “Password at load release” option has been activated, the password keypad will appear. Enter your
password.
Abort and return
to previous
screen
Move to the previous position
Erase the last entry
The name of the user who released the load will be saved and printed on the cycle report.
If the LisaSafe (optional label printer) is connected and the label printing option is activated, the name of
the user who released the load will be printed on the load identification labels
36
7.
RUNNING A STERILIZATION CYCLE
7.1
THE AVAILABLE STERILIZATION CYCLES
The following table shows the available sterilization cycles and the different type of loads that can be
processed in the sterilizer. In total there are 3 type B sterilization cycles available; all offering the ECODRY feature (see below).
B UNIVERSAL 134
(with ECO-Dry)
B PRION 134
(with ECO-Dry)
This is the factory setting default sterilization cycle of the sterilizer (a different
default cycle can be set by the user). The cycle is a type B sterilization cycle
(suitable for all types of loads; solid, porous, hollow A and B; unwrapped,
bagged, single or double wrapped) that features a pre-vacuum phase, a plateau time (sterilization or holding time) of 4 minutes at a temperature of
134°C and a pulsed vacuum drying phase. See the table on the following
page for further details.
This is a special sterilization cycle in accordance with the WHO’s recommendations on CJD (Creutzfeld Jakob Disease) for a longer sterilization plateau.
The cycle is a type B sterilization cycle (suitable for all types of loads; solid,
porous, hollow A and B; unwrapped, bagged, single or double wrapped) that
features a pre-vacuum phase, a plateau time (sterilization or holding time) of
18 minutes at a temperature of 134°C and a pulsed vacuum drying phase.
See the table on the following page for further details.
B UNIVERSAL 121
This is a low-temperature sterilization cycle (121°C) primarily designed to sterilize items that cannot withstand the temperature of 134°C (plastics, textiles).
The cycle is a type B sterilization cycle (suitable for all types of loads; solid,
porous, hollow A and B; unwrapped, bagged, single or double wrapped) that
features a plateau time (sterilization or holding time) of 15 minutes at a temperature of 121°C and a pulsed vacuum drying phase. See the table on the
following page for further details.
ECO-Dry FEATURE
When selecting a “B-UNIVERSAL 134” or a “B-PRION 134” cycle, the
sterilizer automatically adjusts the time of the drying phase to the
amount of load placed, thus delivering the shortest cycle duration
possible at all times. For further details see § 7.1.2.
2.16
Pressure (bar)
B-Universal 134
All available sterilization cycles feature
the same pressure profile as shown in
the graph aside. Only the duration of the
sterilization time (or holding time), drying
time and the sterilization temperature
change.
Time
-1
PV1
PP1 PV2 PP2 PV3
Fractionated
pre-vacuum
PPH
PR
Holding
time
DV
LEV
End
Pulsed
vacuum drying
37
Legend:
PV1 – PV3
Vacuum pulse (removal of air from the sterilization chamber/load)
PP1 - PP2
Pressure pulse (steam injection)
PPH
Pressure pulse and heating (steam injection and heating to sterilization temp.)
PR
Process (plateau/sterilization/holding time)
DV
Vacuum drying
SEP
Water separator draining phase
LEV
Leveling
STERILIZATION CYCLES
B UNIVERSAL 134
Sterilization temperature
Sterilization pressure
B PRION 134
TEST CYCLES
B UNIVERSAL 121
Helix
B&D
Air leakage
Vacuum test
134°C
134°C
121°C
134°C
--
2.16 bar
2.16 bar
1.16 bar
2.16 bar
-0.87bar
Duration of the plateau phase
4'
18'
15'
3'30
10'
Duration of the drying phase
5-16'
5-16'
20'
4'
--
23’
24’
26’
25’
TOTAL CYCLE
DURATION
LOAD TYPE
(including drying
time)
Small
load
Small load
Full Load
Lisa 517
22’
48’
34’
Lisa 522
24’
56’
35’
Full
Load
Small load
Full Load
52’
41’
56’
62’
42’
62’
Full solid (probes,
tweezers, burs,…)
YES
YES
YES
Small porous items
(gauze, cotton,…)
YES
YES
YES
Full porous (80% of the
usable space).
YES
YES
YES
Hollow A (hand pieces,
forceps, scissors,)
YES
YES
YES
Hollow B (vacuum
tips,…)
YES
YES
YES
Unwrapped, bagged,
single/double wrapped
YES
MAXIMUM LOAD
WEIGHT LIMITS:
Empty chamber
or test pack
See appendices
6 and 7
YES
YES
Lisa 517: 4.5 kg solid items / 1.5 kg porous items
Lisa 522: 6.0 kg solid items / 2.0 kg porous items
Total type-B concept: All available sterilization cycles can sterilize and dry all types of loads: full solid, porous, hollow A, hollow B, plastics, rubber, etc.; unwrapped, bagged, single or double wrapped, but :
For preparation of the load, follow the instructions provided by the instrument manufacturer.
For guaranteed sterilization, stay within the maximum load weight limits as specified in this table.
Using the sterilizer with a load type different from the one given in the table above or bigger
than specified in the table above could result in non-sterile conditions at the end of the cycle
and expose people to the hazard of cross-infections.
The indication of sterile load given on the display at the end of the cycle is not valid if the
type and quantity of the load are not complied.
38
7.1.1
Starting a sterilization cycle
Exit from sleep mode by pressing the
"Sleep mode" icon.
Exit sleep mode
Select a cycle by pressing the "Cycle selection"
icon and confirm the selection by pressing the "Selection confirmation" icon.
Enter sleep mode
Confirm selection
Menu
option
Cycle selection
Once a cycle is selected and confirmed, the following screen informs about the maximum load weight limits that can be processed with the selected cycle (see cycle table § 7.1 for further information).
Press the "Start cycle" icon to initiate the selected cycle.
Return to
previous menu
Start cycle
NOTE:
7.1.2
If the “user authentication” option is activated, the user will be asked to identify himself before starting the cycle.
If the password protection is activated as well, a password will be requested.
See §6.11 for further details.
ECO-Dry feature
The ECO-Dry feature is active whenever you initiate a sterilization cycle. The feature is designed to automatically provide you with the shortest possible cycle times always, while assuring that any load placed in
the sterilizer will be perfectly dry at the end of the cycle. The on-board sterilizer computer is able to determine the amount of the load you placed in the sterilizer chamber and will automatically adjust the cycle drying time to that specific load. That means the smaller the load, the faster the cycle, thus eliminating the
need for selecting a quick or a flash cycle. Place loads of 500 grams or less (e.g., up to 8 wrapped dental
handpieces) to enjoy the shortest cycle time of just over 20 minutes. This feature helps you to save time,
energy and money, and works fully automatic.
NOTE:
To enjoy the full benefit of short cycle times when placing small loads, always place the
load on the upper tray of the chamber rack and remove all other trays from the chamber.
Ensure that the paper side of sterilization bags faces up.
39
7.1.3
Cycle in-progress
While a cycle is in progress, the following parameters are displayed on the touch-screen:
Sterilization temperature and pressure – measured inside the chamber.
Elapsed time – time elapsed from the beginning of the sterilization cycle.
Residual time - time remaining until cycle completion.
Current cycle phase (e.g., PV1)
Cycle name
Cycle counter
Cycle name
Info
Manual stop
In the central part of the screen, a simplified
cycle pressure profile is shown. As the cycle
Progress
bar
proceeds, a progress bar overwrites the
Cycle
completed cycle pressure profile, showing in
phase
Cycle
real time the actual phase the cycle is in.
pressure
If you press the "Info" icon, further technical
profile
parameters are displayed. The "Info" icon
can be pressed at any time, also if there is no
Elapsed
Residual
cycle in progress; it provides important infortime
time
mation especially for service technicians.
Cycle counter
7.1.4
End of cycle
Once the cycle is complete, the screen ap- Unlock door
pears as in the image aside.
Info
To unlock the door press the “Unlock door”
icon.
To view the parameters of the last cycle
press the “Info” icon before unlocking the
door.
ATTENTION! Load and trays will be hot at the end of the cycle!
Use tray or cassette holders to remove the load.
NOTE:
If you do not open the chamber door at the end of the sterilization cycle (the sterilization load
remains in the chamber), the sterilizer vacuum pump is activated for a few seconds every 10
minutes for a time period of 40-60 minutes to keep the load dry.
NOTE:
If the “user authentication” option is activated, the user will be asked to identify himself before releasing the load.
If the password protection is activated as well, a password will be requested.
See §6.11 for further details.
The name of the user who released the load will be saved on the memory card and
printed on the cycle report.
40
7.2
MANUAL STOP
A sterilization cycle in progress can be aborted manually at any time by pressing the manual stop icon.
Once pressed, a warning screen will appear asking for a confirmation (see image below, top right). If the
manual stop is confirmed, the alarm code A990 (see picture below) is displayed, and a two-minute reset
phase starts to drain the pneumatic circuits and to depressurize the chamber (see image below, bottom
left). Do not switch off or unplug the sterilizer during this reset phase! At the end of this phase, the door can
be unlocked by pressing the "Unlock door" icon (see image below, bottom right).
Manual
stop
Confirm
Cancel and continue cycle
Unlock door
If a cycle gets interrupted before the sterilization/plateau phase (PR) of the sterilization
cycle is completed, the following message will be displayed:
!! Load not sterile !!
If the cycle gets interrupted after the sterilization/plateau phase of the sterilization
cycle (e.g., during the drying phase), the following message will appear:
!! Sterile conditions achieved, drying interrupted !!
Both messages are printed or saved on the memory card.
41
7.3
REAL-TIME CYCLE DATA INFORMATION
Press the “Info” icon at any time during the sterilization cycle or when the sterilizer is idling to view a list of
the most important technical parameters of the unit (see screen below, right).
Scroll-up
Info
Manual
stop
Pause
Scroll-down
The INFO screen is controlled by an automatic timeout. Press the “Pause” icon to prevent the screen from
automatically returning to the previous screen.
See the table below for a description of the displayed technical parameters:
Legend:
42
P Chamber
Pressure/vacuum inside the sterilization chamber
T Theo.
Theoretical temperature calculated from chamber pressure
T Chamber Heat
Temperature of the chamber heating element
T Steam gen.
Temperature of the steam generator heating element
T Condenser
Temperature of the heat exchanger (condenser)
Power Steam gen.
Power consumption of steam generator
Power Chamber heat.
Power consumption of the chamber jacket heater
Cond. H20
Water conductivity
H20
Water volume pumped inside the steam generator
7.4
CYCLE DATA SUMMARY
Press the "Info" icon at the end of a cycle before unlocking the chamber door (see image below, left)
to view a summary of the cycle parameters (see images below, middle and right).
The information screen lists the following parameters:
Cycle name
Cycle counter
Time/duration, pressure and temperature readings at the end of each cycle phase.
Temperature and pressure readings of the actual sterilization/plateau phase.
Legend:
PV
Vacuum pulse (air removal)
PP
Pressure pulse (steam injection)
PPH
Pressure pulse and heating
PR
Process (sterilization/plateau phase)
DV
Vacuum drying
43
8.
DISPLAY MESSAGES
Once the sterilizer is switched on, a variety of messages can appear on the touch-screen. Messages show
the status of the sterilizer; an example is shown aside.
A message counter indicates the number of messages
pending (e.g., message 01/02).
Messages are divided into three main categories:
Warning messages
Information messages
Maintenance messages
Check the table below for instructions on how to respond
to the various messages
Message
counter
Message
WARNING MESSAGES
Message
Fill water tank
Drain used water
tank
Cause
Action
The clean water tank is empty.
Fill the clean water tank with distilled or demineralized water (see § 5.4).
The used water tank is full.
Drain the used water tank (see § 5.5).
Door locking system The door could not be locked / unlocked
problem - Try again properly.
Check (clean) the door seal and try again.
Call for service if the message persists.
Note: When these messages appear on the screen, the cycle selection command is disabled. It is not possible to
initiate a cycle until the necessary action is carried out.
INFORMATION MESSAGES
According to the sterilizer water conductivity
sensor, the water quality (in terms of µS)
does not conform to the norm and it may
damage the sterilizer (see Appendix 7).
Completely drain the clean water tank and refill
it with water of good quality.
If you use an automated water supply system,
check and replace resin filters.
According to the sterilizer water conductivity
sensor, the water quality (in terms of µS)
Unacceptable water
does not conform to the norm and it may
DO NOT run cycle!
seriously damage the sterilizer (see Appendix 7).
Completely drain the clean water tank and refill
it with water of good quality.
If you use an automated water supply system,
check and replace resin filters.
Non conform water
replace water
CPU battery flat
The CPU board battery is worn.
Lost connection with The sterilizer is unable to establish a conPC/Log
nection with the computer.
Call for service.
Check that the cables between the sterilizer
and the computer or between sterilizer, MOXA
and LAN are inserted correctly. If problem persists, call for service.
MAINTENANCE MESSAGES
Replace bacteriologi- This message informs that the bacteriological filter
cal filter needs to be replaced.
Replace the bacteriological filter (see § 11.6).
Replace dust filter
This message informs that the dust filter
needs to be replaced.
Replace the dust filter (see § 11.7).
Replace door seal
This message informs that the door seal
needs to be replaced.
Replace the door seal (see § 11.9).
Clean clear and used This message informs that the water tanks
water tanks
need to be cleaned.
Clean the water tanks (see § 11.8).
4000 cycles reached This message informs that a 4000 cycle
Call for service
overhaul needs to be performed.
Call for service.
44
Note: When these messages appear on the screen:
It is not possible to initiate a cycle (the cycle selection icon will disappear).
The message must be acknowledged by pressing the “Confirm” icon.
The “Yes” or “No” option from the "Reset counter" screen must be selected.
The necessary actions must be carried out as described above.
The "Reset counter" function allows the user to postpone the necessary action (e.g. when the consumable
part to be replaced is not available).
If you press the “Yes” icon, the maintenance message will disappear and the maintenance counter will be
reinitialized. If you press the “No” icon, the maintenance message will reappear after five cycles and the
counter will keep counting up.
Yes
No
Lisa sterilizers must be maintained according to the maintenance program (see §
11.1). Inadequate or inappropriate maintenance can lead to frequent malfunctions and
expensive repairs and may void the manufacturer’s warranty.
45
9.
ALARMS
Lisa sterilizers constantly monitor a variety of parameters during the sterilization cycle to assure a proper
sterilization of the load. In case any of the parameters are off, potentially affecting the sterilization efficiency, the cycle is immediately interrupted and an alarm message is displayed.
Once the sterilizer generates an alarm message, a twominute reset phase starts to drain the pneumatic circuits
and depressurizes the chamber. Do not switch off or unplug the sterilizer during this reset phase!
At the end of the reset phase, the door can be unlocked by
pressing the “Unlock door” icon. The screen will display the
type of alarm that was generated and indicate the condition
of the sterilization load. Refer to § 10 for alarm-code troubleshooting.
If an alarm message is generated before the sterilization/plateau phase (PR) of the
sterilization cycle is completed, the following message will be displayed:
!! Load not sterile !!
If an alarm message is generated after the completion of the sterilization/plateau
phase of the sterilization cycle (e.g., during the drying phase), the following message
will be displayed:
!! Sterile conditions achieved, drying interrupted !!
Both messages are printed or saved on the memory card.
46
10.
ALARM CODE TABLE
Refer to the table below for troubleshooting assistance in case the sterilizer generates an alarm code.
Code
Description
Action
Power supply
A010
The load cannot be considered sterile. The cycle
Power failure or significant drop in voltage occurred
must be repeated. Check building power supply to
during the cycle.
the sterilizer.
Sterilization chamber
Observe the maximum load weight limits, clean,
check or replace the door seal and the face side of
the chamber and repeat the cycle.
If the problem persists   service.
A100
The time it took to reach the sterilization plateau is
too long (overload, leaks, etc.).
A130
During the sterilization phase of the cycle, the presRepeat the cycle.
sure measured inside the sterilization chamber is
If the problem persists   service.
above the maximum threshold.
A140
During the sterilization phase of the cycle, the pres- Clean, check or replace the door seal and the face
sure measured inside the sterilization chamber is
side of the chamber and repeat the cycle.
below the minimum threshold.
If the problem persists   service.
A150
During the sterilization phase of the cycle, the temperature of the steam is below the minimum threshold.
Clean, check or replace the door seal and the face
side of the chamber and repeat the cycle.
If the problem persists   service.
A160
During the sterilization phase of the cycle, the temperature of the steam is above the maximum threshold.
Repeat the cycle.
If the problem persists   service.
A170
The temperature sensor of the chamber heating
element is broken or disconnected.
  service
A180
The internal temperature sensor of the chamber is
broken or disconnected.
  service
A190
Air detector alarm
Clean, check or replace the door seal and the face
side of the chamber and repeat the cycle.
If the problem persists   service.
Steam generator
A230
The temperature sensor of the steam generator is
  service
broken or disconnected.
A240
Fault of the steam generator heater.
A250
The internal temperature sensor of the air detector
  service
system is broken or disconnected.
  service
47
Code
Description
Action
Vacuum pump
A310
During a vacuum phase of the cycle, a vacuum of
–0.20 bar or lower could not be achieved.
A320
During a vacuum phase of the cycle, a vacuum of
–0.50 bar or lower could not be achieved.
A330
Vacuum pump fault
  service
A350
Vacuum pump fault
  service
A380
Leak between the reading points P1 and P2 of the
Vacuum Test
Clean, check or replace the door seal (see § 11.2)
and the face side of the chamber; repeat the cycle. If
the problem persists   service.
A390
Leak between the reading points P2 and P3 of the
Vacuum Test
Clean, check or replace the door seal (§11.2) and the
face side of the chamber; repeat the cycle.
If the problem persists   service.
Note: Ensure that the sterilizer chamber is cold and
dry when initiating Vacuum Tests!
Water pump
A400
Water pump fault
  service
A410
Water conductivity meter fault
  service
A420
Flow meter fault
  service
Door locking
A520
The chamber door locking mechanism blocked
during opening.
  service
A530
The chamber door locking mechanism blocked
during closing.
  service
Electric valves
A601…8 Electric valve fault
  service
Condenser
A720
Fan fault
  service
Water tanks
A810
Water level sensor fault
  service
Manual stop
A990
48
The “Manual stop” icon was pressed
Wait until the end of the reset phase (see § 7.2).
11.
MAINTENANCE
There are two levels of maintenance:
-
Maintenance performed regularly by the user.
Maintenance carried out by authorized service technicians (see § 11.10).
Before carrying out any maintenance on the unit, remove the mains cable.
11.1 MAINTENANCE PROGRAM
Certain consumables have to be replaced periodically to guarantee a faultless operation of the sterilizer.
Display messages will inform you whenever it is time to replace one of these components. Check the table
below for an overview of the various maintenance tasks and the frequency of replacement.
# of
Consumable
Frequency *
Operation
Description
cycles*
part number
Clean the door seal and the chamber face side.
Monthly
50
§ 11.2
Clean the chamber, the trays and the rack.
§0
Clean the chamber filter.
§ 11.4
Clean the external sterilizer surfaces.
§ 11.5
Replace the bacteriological filter.
§ 11.6
Replace the dust filter.
see
Appendix 9
800
Clean both water tanks.
-
§ 11.8
800
Replace the door seal.
see
Appendix 9
§ 11.9
4000
Have the sterilizer serviced by an authorized
service technician.
-
§ 11.10
Every 3
months
400
Every 6
months
Every year
§ 11.7
* whichever comes first
In addition to the maintenance program above, local or national rules, guidelines
and standards could mean that periodical checks, maintenance and calibration of
the sterilizer are required.
The sterilizer shall be checked, maintained and serviced in accordance with all
rules in force in the Country of use.
The Maintenance sub-menu (see § 6.5) indicates the
number of cycles remaining before it is time to replace the
various consumables or when general servicing is required. The maintenance counter decreases in value after
each cycle. When one of the counters reaches 0, the corresponding message appears on the touch-screen (see §
8).
Maintenance
counter
Reset the
highlighted
counter
Scroll
up
Scroll
down
49
11.2
CLEANING THE DOOR SEAL
ATTENTION!
Operation to be carried out when the
sterilization chamber is cold
Clean the door seal and the chamber face side with a non abrasive cloth and a mild detergent solution. Rinse with clean water.
11.3
CLEANING THE CHAMBER AND CHAMBER COMPONENTS
ATTENTION!
Operation to be carried out when the sterilization chamber is cold
Remove the trays from the chamber.
Remove the chamber rack.
Clean the chamber with a damp sponge and a mild detergent solution.
Rinse the chamber with a sponge and remove all traces of the cleaning agent.
Apply the same procedure for the rack, trays or cassettes.
Thoroughly clean all around the sterilization chamber and the internal chamber interface at the back of the chamber.
Do not bend or damage the temperature sensor at the bottom/right of the chamber.
Never use disinfectants or sharp objects to clean the chamber.
11.4
CLEANING THE CHAMBER FILTER

ATTENTION!
Operation to be carried out
when the sterilization chamber
is cold



50

Empty the sterilization chamber by removing
the trays and rack.
Remove the filter cap at the back of the
chamber (bottom/center) by turning it counter-clockwise.
Remove the cartridge filter and rinse it with
tap water.
Insert the filter on the cap, plug it in and lock
it by turning clockwise.
11.5 CLEANING THE EXTERNAL STERILIZER SURFACES
Disconnect the mains cable.
Never use disinfectants or abrasive products.
Clean all external covers with a damp cloth and a mild detergent solution.
Do not use excessive amounts of water to wash the sterilizer as this may
damage the electrical components and safety mechanisms.
Take care not to scratch the plastic film in front of the touch-screen; avoid cleaning it with detergents or pointed objects.
11.6 REPLACING THE BACTERIOLOGICAL FILTER
Open the service door.
Unscrew the bacteriological filter by hand (counter-clockwise).
Screw on the new filter (clockwise) and tighten it snug.
ATTENTION!
Disposal of used consumables shall be done in
compliance with local laws and rules
11.7 REPLACING THE DUST FILTER
Pull out the filter from the bottom/front of the sterilizer.
Detach the used filter from the handle.
Attach the new filter to the handle.
Slide the filter back into its position.
ATTENTION!
Disposal of used consumables shall be
done in compliance with local laws and
rules
51
11.8
CLEANING THE WATER TANKS
Disconnect the mains cable.
Completely drain both tanks (see § 5.5).
Leave the drain tube attached to one of the drain
quick connectors.
Turn the 5 screws of the tank cover a ½ turn counterclockwise with the use of a screwdriver (or coin; see
image to the right) and lift the cover to gain access to
the water tanks.
Tap with your fingers on the rubber membrane to
remove any condensation water (see image below/left).
Remove the rubber membrane; clean and dry it. Do not yet remove the two internal tank filters (A)
(see image below/right).
Clean the internal tank surfaces with a soft sponge and a mild detergent solution, then rinse and dry
them. Do not use abrasive or strong detergents or disinfectants. Use a small non-abrasive brush to
clean areas that are difficult to reach. Repeat this procedure for both tanks; make sure the drain tube
it attached to the drain quick connector of the tank you are cleaning (left tank = used water tank –
gray colored connector; right tank = clean water tank – blue colored connector).
Remove the two internal tank filters (A), clean them with tap water (mild detergent can also be used)
and put them back into their positions.
Reposition the rubber membrane by carefully inserting it into its outer seat and the tank dividing wall.
Close the cover and tighten the 5 tank cover screws (clockwise).
If the sterilizer is not used for more than 3 days, both water tanks should be completely
drained in order to avoid algae growth or any other deposits.
52
11.9 REPLACING THE DOOR SEAL
ATTENTION!
Operation to be carried out when the sterilization chamber is cold
Fully open the chamber door of the sterilizer.
Pull out the used door seal by hand.
Carefully clean the seal seat and the chamber face side with a cotton swab moistened with isopropyl
alcohol.
Moisten the new seal with water.
Insert the seal in the sequence as illustrated in the following diagrams:
FIRST: top and bottom
THEN: left and right
Complete the operation by evenly inserting the seal on the entire circumference.
Make sure that the door seal is properly placed to avoid air leaks. It must be evenly inserted on the entire circumference without any bumps or deformations.
ATTENTION!
Disposal of used consumables shall be done in compliance with local laws and rules
53
11.10 SERVICE CONDUCTED BY AN AUTHORIZED SERVICE TECHNICIAN
Regular service is imperative to ensure continuously effective sterilization. LISA 517/522 Sterilizers require
servicing every 4000 cycles by authorized service technicians. The service includes replacement of consumables and other important internal components, a safety and system check as well as thorough cleaning of areas that cannot be accessed by the user.
Replacement parts:
2 Metallic water filters
1 One way valve
2 Solenoid valves (EVE-EVF)
2 Metallic filters - (CH/SG)
2 Pressure safety valve 0-rings
1 Air detector O-ring
1 PT1000 Teflon compression bushing
1 Water separator one way valve
1 Interface one way valve (air)
1 EV A-B-C solenoid valves assembly
1 Vacuum Pump membrane kit
Cleaning:
Cleaning of the sterilization chamber and external surfaces
Cleaning of the sterilization chamber filter
Vacuum-cleaning of the interior of the unit, paying particular attention to the
condenser fins
Checks:
Check of the pneumatic connections.
Check of the electrical connections.
Check of the temperature and pressure calibration.
Check of the door locking system.
Check of the 2 pressure safety valves.
Check of the safety systems.
Check of the steam generator.
54
12.
USE OF THE MEMORY CARD
Lisa 517/522 sterilizers come with a digital cycle data recording system. Cycle data is automatically saved
on a removable/rewritable memory card. Data from memory cards can be managed with your PC or MAC.
Memory cards are supplied with a USB cable and an external USB reader.
Insert the memory card into the dedicated slot behind the service door until it clicks into its final position.
Ensure that the flat corner of the card points to the top/right (see image below). Once a card is inserted,
the unit automatically verifies the condition of the card. The verification time of the memory card takes from
a few seconds to some minutes. It is possible to reduce the verification time if the card is formatted directly
on the sterilizer (see § 6.7.2).
NOTE 1
NOTE 2
Periodically transfer cycle data from
the card to your computer.
The manufacturer does not take responsibility for any damages to the
memory card or loss of data during or
after the warranty period.
To remove the memory card, slighty push it in and
gently pull it out.
12.1 TECHNICAL CHARACTERISTICS OF THE MEMORY CARD
Technology
MMC (Multi Media Card)
Tested brands that can be used with the Lisa
*PQI-Sandisk-Lexar-Transcend-TwinMos-Toshiba
sterilizer
Tested capacity
between 16MB - 1GB
* Brands and products are trademarks of the manufacturers
The supplied memory cards have a storage capacity of not less than 128 MB.
12.2 READING OF MEMORY CARD DATA WITH A PC/MAC
Memory card data can be saved, viewed, copied and printed on a PC/MAC equipped with a USB port
(USB 1.1 or above).
12.3 MINIMUM HARDWARE REQUIREMENTS FOR A PC/MAC
PC/MAC
1 free USB port (1.1 or above)
PC/MAC
CD-ROM reader
PC Operating System
*WINDOWS 98SE, 2000, ME, XP or above
MAC Operating System
*OS 9.1.x, OS X v10.1.2+
* Brands and products are trademarks of the manufacturers
55
12.4
CONNECTING THE EXTERNAL USB CARD READER TO YOUR PC/MAC
To connect the USB reader to your PC/MAC, follow these steps:
Start the PC/MAC
Connect the USB reader to a free USB port on your computer.
NOTE 1
Most operating systems recognize the USB reader and install the device automatically. In
some cases the operating system asks for the installation disk. To complete the installation
follow the messages on your computer screen. For further information refer to the instructions supplied with the USB reader.
NOTE 2
If the computer is connected to a network system it is possible that the USB reader drive is
not visible on your computer even after correct installation. In this case consult your network
administrator or assign a different drive letter to the USB reader.
Once the installation is completed and a memory card with cycle data is inserted into the external card
reader, data can be saved, copied and organized on your PC/MAC.
12.5
SAVED FILE
The sterilization report is saved in a file with a HTM extension. It can be opened, viewed and printed with a
HMTL viewer (e.g., *Microsoft Internet Explorer).
* Brands and products are trademarks of the manufacturers
12.6
CONTROL CODE
Saved files contain a control code for proper identification. Any manipulation of a file will change the code
and compromise the integrity of the saved data. W&H Sterilization will not take responsibility for any manipulated cycle data.
12.7
FILE NAMES
Each cycle report is saved as a file in a HTM format. File names are generated automatically.
Example of a file name:
01898 28-01-06 08_41_22 B&D _ HELIX LISA 517 02-0005.htm
saving format depends on the Date-Clock setting (see § 6.1.10 and 6.1.11)
12.8
DIRECTORY NAME
Files are saved on the memory card in the following structure:
LISA 517 02-0005
∟2006-01
∟01898 28-01-06 08_41_22 B&D _ HELIX LISA 517 02-0005.htm
56
12.9 MEMORY CARD MANAGEMENT
As soon as a memory card is inserted the unit automatically checks the card.
In case the recorder detects that the memory card is
damaged or defective, the following screen is shown.
Confirm
Press the “Confirm” icon and replace the card.
If the card is not formatted or if it is formatted with a different standard (e.g., FAT 12) the following screen is
shown.
Cancel
Press the “Confirm” icon to proceed with the formatting.
Confirm
A confirmation screen will appear, warning you that all
data will be lost if you proceed with the formatting. Press
the “Confirm” icon to proceed or press “Cancel“ to return Cancel
to the main menu.
Confirm
57
If the “Confirm” icon is pressed the formatting begins.
During formatting the system also checks for errors. If it
detects any errors the following screen is displayed. Press
the “Confirm” icon to return to main menu and replace the
card.
Confirm
12.10 SAVING A FILE
If a memory card is inserted, cycle data is saved automatically on the card at the end of every cycle. Is no card inserted, the following screen will be displayed.
Press the “Confirm” icon to get to the cycle end screen.
You always have the option to print or save data of the
most recent cycle (see § 6.4).
Confirm
NOTE
58
No activity will take place if a memory card is inserted while a cycle is in progress. At the
end of the cycle, the memory card will be verified and cycle data will be saved.
13.
TROUBLESHOOTING
Please find below a table of potential problems and easy solutions. For further troubleshooting information
please also refer to § 8 (Display messages) and § 9 (Alarms).
PROBLEMS
The sterilizer remains
switched OFF.
POTENTIAL CAUSES
SOLUTIONS
The main switch or network circuit breaker is OFF.
Activate the main switch or network circuit
breaker (ON).
No voltage at the socket.
Check the electrical power supply.
The mains cable is not properly Plug in the mains cable.
connected.
Water is leaking at the
front of the sterilizer.
Leaks through the chamber
door seal.
Clean or replace the door seal (§ 11.2) and
clean the chamber face side.
Clean water tank got overfilled
or sterilizer got tilted.
Stop filling the clean water tank as soon as
you hear the audible beep tone. If you tilt the
sterilizer some water may leak at the front.
Countertop not properly leveled.
The sterilizer must be installed on a level surface.
At the end of the cycle,
Overloaded chamber.
water remains inside
the chamber and the
load is not perfectly dry. Chamber filter clogged.
Load incorrectly placed.
Comply with the maximum load weight limits
for each type of load (§ 7.1). Always use the
chamber rack for trays and cassettes.
Remove and clean the chamber filter (see §
11.4).
Follow the recommendations as listed in Appendix 2.
Tap water on instruments when Ensure that instruments are dry before they
placed in the sterilizer.
are placed in the sterilizer.
Oxidation or spots on
instruments.
Use of water of poor quality or
water containing chemical substances.
Drain both water tanks (§ 11.8). Use water of
good quality (see Appendix 7).
Organic or chemical residues
on the instruments.
Clean, rinse and dry instruments before placing them in the sterilizer (see Appendix 2).
Ensure that instruments of different materials
Contact between instruments of do not touch (aluminum, carbon or stainless
different materials.
steel, etc.); place them on different trays or
cassettes or bag/wrap them.
Instruments are turning
brown or black.
Scale deposits on the chamber.
Clean the chamber and use water of good
quality (see Appendix 7).
Incorrect temperature selected.
Select a sterilization cycle featuring a lower
sterilization temperature. Follow the instructions of the instrument manufacturer.
Before sending the sterilizer to technical service, remove the mains cable, empty
both water tanks and use the original or appropriate packing.
59
14.
RECYCLING / DISPOSAL INSTRUCTIONS
Lisa 517/522 sterilizers are mainly built from fiber-reinforced polymers, metals and electronic components.
In case of disposal, separate the various components according to the materials they are made of. Drop
the sterilizer with a company that specializes on recycling of related products. Do not abandon the sterilizer
in unsecured places.
When disposing of the sterilizer, as well as of used consumables, always refer to current/applicable laws in
the country of use.
60
APPENDIX 1
TECHNICAL CHARACTERISTICS
Electrical supply:
Sterilizer:
Working temperature
Working relative humidity
Storage temperature / relative humidity
Max. altitude
Min. atmospheric pressure
Nominal voltage
Max. absorbed power
Max. current
Overall dimensions
Max. space required
Size of the door movement
Weight (empty / full loaded)
Max. heat output
Max. noise level
Steam generator:
Power / voltage
Max. pressure / max. temperature
Safety overload valve
Sterilization chamber:
Power / voltage
Max. pressure / max. temperature
Safety overload valve
Total volume
Usable space (identical for all cycles)
Bacteriological filter
Distilled or demineralized water:
Water quality
Min. / max. water consumption per cycle
Tank volume
Single phase 200-240 VAC (±10%); 50/60 Hz; 10 A
From +5°C to +40°C
Max. RH 80% up to 31°C, lineary decreasing to 50% at 40°C
From -20°C to +60°C / 0-90% (empty tanks)
3,000 m asl
0.65 barA
200 - 240 VAC
2,000 – 2,400 W
10 A
W 450 mm / H 435 mm / D 599 mm
W 470 mm / H 485 mm / D 650 mm
W 360 mm / H 410 mm / D 360 mm
LISA 517: 40 / 52 kg
LISA 522: 50 / 63 kg
3,000 kJ/hour
62 dB
2,000 W / 200 VAC
3 bar / 144°C
3 bar
1,000 W / 200 VAC (1,400 W / 240 VAC)
2.6 bar / 140°C
2.6 bar
17 l / Ø 250 mm x D 362 mm (LISA 517)
22 l / Ø 250 mm x D 440 mm (LISA 522)
12 l / L 195 mm x H 205 mm x D 300 mm (LISA 517)
15.5 l / L 195 mm x H 205 mm x D 385 mm (LISA 522)
0.3 µm debris filter
Conform to EN 13060 Annex C (water conductivity < 15µS/cm)
0.30 l / 0.55 l (full porous load - LISA 517)
0.40 l / 0.60 l (full porous load - LISA 522)
3.5 l (good for 8 to 12 cycles depending on load type and weight)
Communication:
1 parallel port - 2 serial ports on the back of sterilizer
Miscellaneous:
Fully micro-processor controlled / touch-screen
Programmable sleep-mode
STERILIZER featuring type B sterilization cycles conform with following directives and norms :
93/42/CEE
Medical Device Directive (MDD)
97/23/CEE
Pressure Equipment Directive (PED)
2002/96/CEE
Waste Electrical and Electronic Equipment (WEEE)
UNI EN 554
Sterilization of medical devices: validation and routine control of sterilization by most heat
EN 13060
Small steam sterilizers
IEC 61010-1
Safety requirements for electrical equipment for measurement, control and laboratory use: general requirements
IEC 1010-2-040
Safety requirements for electrical equipment for measurement, control and laboratory use; particular requirements for autoclaves using steam for the treatment of medical materials and for laboratory processes
EN 61326
Electrical equipment for measurement, control and laboratory use EMC requirements
Name plate on the steam
generator
Name plate on the chamber
Name plate on the back of the sterilizer
61
APPENDIX 2
1.
STERILIZATION LOAD PREPARATION
Cleaning the instruments
Thorough cleaning of all items prior to sterilization is imperative to ensure effective sterilization. If visible
debris and bio-burden is not removed through cleaning prior to sterilization, it will interfere with microbial
inactivation and compromise the sterilization process!
If possible, clean instruments immediately after use; always follow instrument manufacturer instructions.
Remove all traces of disinfectants from the instruments as this may cause corrosion during the
sterilization process. Rinse and dry instruments thoroughly.
Lubricate dental handpieces after cleaning, prior to sterilization, in accordance with the handpiece
manufacturer’s instructions.
2.
Preparing the trays
Do not overload the chamber; adhere to the maximum load weight limits as listed in “The available
sterilization cycles” in this manual.
Always use the chamber rack to allow adequate steam circulation.
Place pouched items on trays with the paper side facing up.
Do not overload trays; spread single items on multiple trays.
Place cassettes in the vertical position (if possible) to enhance drying.
Place empty containers or non-perforated trays upside down to prevent accumulation of water.
Items made from different materials (stainless steel, carbon steel, aluminium, etc.) must be placed on
separate trays or wrapped/pouched.
If instruments are manufactured from carbon steel, paper should be placed between them and the
sterilizer tray.
Sterilize hinged instruments (e.g., forceps, extraction pliers, etc.) in the opened position.
Wrap items with porous wrapping materials to facilitate steam penetration and drying (e.g., sterilization
bags for autoclaves).
3.
Tubes
Rinse, drain and dry after washing.
Place tubes on a tray allowing the ends to remain open. Do not bend tubes.
4.
Wrapped / bagged items
Abort and return
to previous
Sterilization bags should be placed on trays allowing adequate space
in-between bags.
Ensure that packs do not touch the sterilizer chamber walls.
Place sterilization bags with the paper side facing up.
62
APPENDIX 3
MAINTENANCE OF DENTAL HANDPIECES
1.
External disinfection
This procedure reduces the risk of infection during cleaning and maintenance of the instrument.
Wear protective gloves during disinfection.
Refer to the instructions of the instrument manufacturer.
Avoid using abrasive disinfectants (ph-value 2.5 – 9; no chlorine based disinfectants).
We recommend the use of disinfectant wipes rather than spray disinfection.
Do not immerse instruments in disinfectants.
Residual disinfectants on instruments can cause extensive damage to your instrumentation during
sterilization (oxidation, alteration of technical characteristics of seals, rubbers, fiber optics, etc.).
2.
External cleaning
This procedure involves the removal of residues (blood, dentine, etc.) that adhere to critical areas
such as spray outlets, light ports, knurling etc.
Wear protective gloves during cleaning.
Refer to the instructions of the instrument manufacturer.
Use a soft, damp brush and take care not to scratch the surface of the light ports.
3.
Lubrication
Once the instrument has been disinfected, cleaned and dried (free from residues), it must be lubricated prior to sterilization.
Follow manufacturer’s instructions for proper lubrication.
4.
Packaging
In order to preserve sterility, rotating instruments should be wrapped prior to sterilization. Follow the
manufacturer’s packing instructions when using sterilization packaging (also see “Sterilization load
preparation” in the appendix section of this manual).
63
APPENDIX 4
BOWIE AND DICK TEST
The Bowie & Dick (B&D) Test device, also called Steam Penetration Test device, is representative of the
small porous type load. It comprises several sheets of paper wrapped in a small packet in the middle of
which there is a chemical heat-sensitive indicator sheet.
This test is used to validate the sterilizer performance in terms of textile load sterilization, that is:
Pre-vacuum efficiency and thus steam penetration
Temperature and pressure parameters of saturated steam achieved during the plateau/holding time.
The Bowie & Dick test cycle profile is identical to the profile of the B UNIVERSAL 134 sterilization cycle,
with the following differences:
The plateau period (PR) is shorter (3 minutes 30 seconds instead of 4 minutes), assuring a 30
seconds security margin.
The drying time is reduced to 4 min to not affect the chemical indicator through drying and to save
time. It is therefore normal that the test pack will be wet at the end of the test cycle.
How to carry out the test:
The test must be performed in an empty chamber (EN 13060) without load but with the standard
chamber accessories (chamber rack and trays) mounted.
Place the Bowie & Dick test pack in the center of a tray in the lowest rack position.
Select and initiate the Helix / B&D test cycle from the "Test cycles" submenu.
Once the cycle is finished, open the sterilizer door and remove the test pack.
CAUTION: The packet will be hot!
For correct interpretation of the test results, refer to the instructions of the
test pack manufacturer.
Remove the indicator sheet from the center of the test pack and check the change in colour as explained below:
TEST PASSED
The entire surface of the indicator sheet has
changed colour
TEST FAILED
Certain areas of the indicator
sheet have not changed colour,
e.g., the central part has not
turned dark due to an air pocket
in the center of the test pack
Any unexpected colour change, such as the center of the indicator sheet being paler or of a different colour
than the edges, indicates that there was an air pocket present during the cycle due to sterilizer malfunction.
If the test fails repeatedly call technical service. Follow local/national guidelines on the frequency of testing.
64
APPENDIX 5
HELIX TEST
The Helix Test device is representative of the type A hollow load (EN 13060). It consists of a 1,500 mm long tube
that is open on one side and closed with a capsule on the
other side. An indicator strip is placed inside of the capsule.
Indicator strip
This test is used to validate the sterilizer performance in terms of hollow A load sterilization, that is:
Pre-vacuum efficiency; rapid and uniform steam penetration.
Temperature and pressure of saturated steam achieved during the plateau/holding phase.
The Helix Test cycle profile is identical to the profile of the B UNIVERSAL 134 sterilization cycle with the
following differences:
The plateau period (PR) is shorter (3 minutes 30 seconds instead of 4 minutes), assuring a 30
seconds security margin.
The drying time is reduced to 4 min to not affect the chemical indicator result through drying and to
save time.
How to carry out the test:
The test must be performed in an empty chamber (EN 13060) without load but with the standard
chamber accessories (chamber rack and trays) mounted.
Place an indicator strip inside the capsule. See the test manufacturer instructions.
Close the capsule.
Place the Helix Test in the center of a tray in the lowest rack position.
Select and start the B&D / HELIX test cycle from the “Test cycles” submenu.
Once the cycle is completed, open the sterilizer door and remove the test.
CAUTION: The test will be hot !
For correct interpretation of the test results, refer to the instructions of the
test manufacturer.
Remove the indicator strip from the capsule and check the change in colour as explained below:
PASSED
FAILED
The chemical indicator has turned dark .
Part of the chemical indicator has not turned dark;
e.g. due to residual air inside the capsule.
Insufficient colour change of the indicator strip indicates that there was an air pocket present during the
cycle due to sterilizer malfunction. If the test fails repeatedly call technical service. Follow local/national
guidelines on the frequency of testing.
65
APPENDIX 6
VACUUM TEST
Use this test to validate the performance of the sterilizer in terms of leakage. During the test the following is
checked:
Efficiency of the vacuum pump.
Tightness of the pneumatic circuit.
The cycle profile specific for this test
includes:
A vacuum phase up to P1 (-0.87 bar).
A stabilization period of 5 min.
=> T2. Reading of P2.
A testing period of 10 min.
=> T3. Reading of P3.
The microprocessor makes the following calculation: P3 - P2. The result must be less than 0.013 bar.
When performing a Vacuum Test, the sterilizer chamber must be completely dry
and cold. By not following this instruction, the Vacuum Test might fail even if the
sterilizer works properly.
How to carry out the test:
Select and initiate the Vacuum Test cycle from the "Test cycles" submenu.
A display message will inform at the end of the test cycle if the test passed or failed. If the test failed,
check, clean or replace the door gasket, clean the chamber face side and repeat the test. If the test fails
repeatedly call technical service. Follow local/national guidelines on the frequency of testing.
66
APPENDIX 7
WATER QUALITY
W&H Lisa sterilizers use distilled or demineralized water to generate steam for the sterilization process.
Water quality sensors constantly monitor the quality of the water used for sterilization as water of too high
mineral content can seriously damage the sterilizer and impair the sterilization process.
The total mineral content of water used for sterilization has to be lower than 10 ppm (parts per million) or if
a conductivity meter is used to check the water quality, the conductivity has to be lower than 15 µs/cm.
The table below lists the water quality to be used for steam sterilization (see EN 13060 APPENDIX C).
Contaminants of feed water
Values
Evaporate residue
< 10 mg/l
Silicon oxide, SiO2
< 1 mg/l
Iron
< 0,2 mg/l
Cadmium
< 0,005 mg/l
Lead
< 0,05 mg/l
Rest of heavy metals, excluding iron, cadmium, lead
< 0,1 mg/l
Chloride
< 2 mg/l
Phosphate
< 0,5 mg/l
Conductivity (at 20°C)
< 15 µs/cm
pH value
5-7
Appearance
colorless, clean, without sediment
Hardness
< 0,02 mmol/l
If the sterilizer generates a display message in regards to poor water quality, check the water source (refer
to the water treatment system user manual; replace resin cartridge etc.). In case distilled or demineralized
water is purchased from the market, switch to a brand of better quality.
The use of water with a conductivity greater than 15µS/cm may affect the sterilization process and damage the sterilizer (EN 13060). A conductivity greater than
50µS/cm may strongly affect the sterilization process and seriously damage the
sterilizer.
The use of water for steam generation with contaminants at levels exceeding
those listed in the table above, can greatly shorten the working life of the sterilizer
and void the manufacturer's warranty.
67
APPENDIX 8
68
EXAMPLE OF A CYCLE DATA REPORT
APPENDIX 9
ACCESSORIES
DESCRIPTION
ORDERING NUMBER
LisaPrint
A70010xx
F523204x (Lisa 517)
F523205x (Lisa 522)
Perforated anodized aluminium tray
Chamber racks:
190x43x300/375 *
Chamber rack
(Europe)
190x43x300/375 *
F523008x (Lisa 517)
F523009x (Lisa 522)
190x43x300/375 *
Chamber rack
(USA)
205x35x300/375 *
210x35x300/375 *
205x35x300/375 *
F523020x (Lisa 517)
F523021x (Lisa 522)
190x32x300/375 *
Chamber rack
(for 4 cassettes)
210x32x300/375 *
210x32x300/375 *
F523012x (Lisa 517)
F523015x (Lisa 522)
190x32x300/375 *
190x70x300/375 *
Chamber rack
(for 2 implant cassettes)
190x70x300/375 *
F523016x (Lisa 517)
F523017x (Lisa 522)
Tray holder
F523001x
Drain tube
S230900x
Mains cable
U38010xx
Funnel
F540903x
Bacteriological filter
W322400x
69
DESCRIPTION
ORDERING NUMBER
Door seal
F460504x
Dust filter
F364502x
Wall spacer
F190107x
Memory card USB reader
A801002x
Memory card
A801001x
Safety bracket +screws
X051019x
Used water tank continuous drain kit
G005306x
70
APPENDIX 10
HELIX TEST DOCUMENTATION FORM
Documentation
For the documentation of sterilization cycles
After the sterilization process the chemical indicator strip that was used in the “Helix Test” should be attached here (the strip comes with an adhesive part). The sterilization process was successful when the
previously yellow marked spots turned to a consistent dark color.
Operator No. 1:______________________ Operator No. 2:_________________________
Operator No. 3:______________________ S/N of the sterilizer ____________
Date
Cycle
No.
Operator
No.
Released
Yes - No
Signature
Chemical indicator
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
71
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