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Lisa
User manual
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W&H Lisa User manual

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Table of Contents
1. INTRODUCTION................................................................................................................................................... 1
2. UNPACKING ........................................................................................................................................................ 3
3. UNIT DESCRIPTION ............................................................................................................................................ 4
4. INSTALLATION .................................................................................................................................................... 8
4.1.1 Securing the sterilizer with a safety bracket ................................................................................. 8
4.4.1 LAN connection ......................................................................................................................... 10
4.4.2 Serial connection ....................................................................................................................... 10
4.5.1 Connecting an external water supply system (demineralizer) .................................................... 11
4.6.1 Connecting the drain tube .......................................................................................................... 11
5. GETTING STARTED .......................................................................................................................................... 12
5.4.1 Manual filling .............................................................................................................................. 14
5.4.2 Automated water supply (optional) ............................................................................................ 14
5.5.1 Manual draining ......................................................................................................................... 15
5.5.2 Continuous draining ................................................................................................................... 15
5.6.1 Inserting / removing the memory card ....................................................................................... 15
6. PROGRAMMING ................................................................ ................................................................................ 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
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6.7.1 System info ................................................................................................................................ 25
6.7.2 Formatting the memory card ...................................................................................................... 25
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
6.11.1 Starting a sterilization cycle ....................................................................................................... 35
6.11.2 End of a sterilization cycle ......................................................................................................... 36
7. RUNNING A STERILIZATION CYCLE .............................................................................................................. 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
8. DISPLAY MESSAGES ....................................................................................................................................... 44
9. ALARMS ........................................................................................................................................................... 46
10. ALARM CODE TABLE ....................................................................................................................................... 47
11. MAINTENANCE ................................................................................................................................................. 49
12. USE OF THE MEMORY CARD .......................................................................................................................... 55
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
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1. INTRODUCTION
NOTE:
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.
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.
1.2 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.
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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.
Not observing the instructions as specified in this manual can lead to unsafe opera­tion for the user.
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.
1.6 GENERAL AND SAFETY RECOMMENDATIONS
o The user is responsible for the proper installation, the correct use and maintenance of the steri-
lizer in accordance with the instructions listed in this manual. For further information call your local service provider.
o The sterilizer has not been designed for the sterilization of liquids. o The sterilizer must not be used in the presence of gas or explosive vapours. o The chamber is automatically heating to 120°C as soon as the sterilizer is switched on. o 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.
o Do not exceed the maximum load weight limits as specified in this manual (see § 7.1) o Do not remove the name plate or any label from the sterilizer. o To avoid electrical short circuits, do not pour water or any other liquid over the sterilizer. o Switch off the sterilizer and unplug the mains cable before inspecting, carrying out maintenance
or servicing the sterilizer.
o Repairs, maintenance or service must be carried out by authorized W&H service technicians
only with the use of original spare parts.
o In case of transport:
- Drain both water tanks completely (§ 5.5).
- Allow the sterilization chamber to cool down.
- Use original or appropriate packaging.
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2. UNPACKING
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.
Total weight:
Lisa 517 40 kg Lisa 522 50 kg
NOTE:
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.
ACCESSORIES PLACED INSIDE THE STERILIZATION CHAMBER
Accessory
Description
Quantity
Tray
Perforated anodized aluminum tray
5
Reversible rack
Stainless steel rack to accommodate 5 trays or 3 cassettes.
Optional racks available (see Appendix 8). For more information contact your dealer.
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
2.1 UNPACKING THE STERILIZER
2.2 STANDARD ACCESSORIES
Following accessories are supplied together with the sterilizer:
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Sliding cover for manual filling of the clean water tank
Service door
Chamber
door
Door seal
Sterilization
chamber
Dust filter
Touch- screen
Door pin
Water tank cover
Bacteriological filter
Main switch
Quick connector for
manual draining of
clean water tank
Quick connector for
manual draining of
used water tank
Connection to unlock the chamber door (ser­vice technicians only)
Connection for the Air Detector Test Device (optional)
Memory card slot
3. UNIT DESCRIPTION
3.1 FRONT VIEW
3.2 SERVICE DOOR
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3.3 REAR VIEW
Circuit breaker
(manual reset)
Mains plug socket
Condenser vent
Mains cable guide
Parallel port (printer)
Safety valve cover Male serial port
Air filter
Plug for an external water supply system
Test connection
D1
D2
D3
D4
Fitting for continuous draining of used water
Fitting for an external
water supply system
Female serial port
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NOTE:
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.
Used water tank
Water level sensors
Quick connector for
manual draining of
clean water tank
Quick connector for ma­nual draining of used water tank
Water inlet for manual filling of
clean water tank
Fittings for automatic fill­ing/draining of tanks
Clean water tank
Vent
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).
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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.
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
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.
H
W
D
3.6 USABLE SPACE IN THE CHAMBER
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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.
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.
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113
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.
Wall
Minimum distance
(millimeters)
2 holes Ø3x20
Screws Ø4,8x22
4. INSTALLATION
4.1 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)
4.1.1 Securing the sterilizer with a safety bracket
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4.2 ELECTRICAL POWER SUPPLY
- 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.
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.
The electrical power supply of the sterilizer must comply with all applicable standards in the country of use. The following characteristics are required:
4.3 PRINTER (optional)
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W&H does not accept any responsibility should the MOXA interfere with the normal functioning of your network.
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.
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
- 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.
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.
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4.5 DEMINERALIZER (optional)
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 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)
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 manuals.
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 steri-
lizer.
- 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.
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.
D4 = draining
DRAIN
WATER
SUPPLY
Interface
cable
D2 = filling
W&H Sterilization offers external water supply systems for automated supply of demineralized water to the sterilizer(s) (Dem32 or Osmo).
4.6 CONTINUOUS DRAINING (optional)
4.6.1 Connecting the drain tube
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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:
Menu option
Sleep mode
Available cycles
Current date
Current time
Cycle selection
Cycle counter
Selection
confirmation
Start cycle
5. GETTING STARTED
5.1 THE USER INTERFACE
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 confir- mation” icon.
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.
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5.2 INITIAL WARNINGS AND SLEEP MODE
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.
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).
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.
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.
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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).
Every time you fill the clean water tank, drain the used water tank (see § 5.5).
If an automated water supply system is connected to the sterilizer (see §
4.5), the clean water tank automatically fills 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.
5.4 FILLING THE CLEAN WATER TANK
5.4.1 Manual filling
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.
5.4.2 Automated water supply (optional)
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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.
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!
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.
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.
5.5.1 Manual draining
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.
5.6 MEMORY CARD
5.6.1 Inserting / removing the memory card
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Press the menu icon to view the list of availa­ble options.
The available menu options are shown below:
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 *
§ 6.1.6 – Manual printing *
§ 6.1.7 – Storage time *
§ 6.1.8 – User name
§ 6.1.9 – Date-Clock setting
§ 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
* The sub-menus related to label printing are only available when the label printer LisaSafe is con­nected.
6.1.1 Language
Use this menu to select the user interface lan­guage.
Menu
Exit and return to
higher menu level
Scroll up
Scroll-down
Current selection
Confirm and re-
turn to previous
menu
Exit and
return to higher
menu level
Scroll up
Current selection
Scroll down
Confirm and return to
previous menu
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.
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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 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 press-
ing 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.
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.
Confirm and return to
previous menu
Exit and return to
higher menu level
Increase time
Decrease time
Increment
Exit and return to
higher menu level
Decrement
Move next
User
or office name
Confirm and return
to previous menu
Move previous
Exit and return to
higher menu level
Increment
Decrement
Confirm and return
to previous menu
Date
Time
Move next
Scroll up
Current selection
Scroll down
Confirm and return
to previous menu
Exit and return to
higher menu
level
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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.
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.
6.1.12 Display contrast
Use this menu to change the screen contrast for a better visualization in regards to the sur-
rounding environment. Press the “Increase
contrast” and “Decrease contrast” icons to ad-
just 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.
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.
Exit and return to
higher menu level
Scroll up
Scroll down
Confirm and return
to previous screen
Exit and return to
higher menu level
Scroll up
Scroll down
Confirm and return
to previous screen
Exit and return to
higher menu level
Increase
Decrease
Confirm and return
to previous screen
Exit and return to
higher menu level
Increase
Confirm and return
to previous screen
Decrease
Exit and return to
higher menu level
Scroll up
Scroll down
Confirm and return
to previous screen
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6.1.15 Night cycle shortcut
Select the “Night cycle shortcut” option by pressing ”Scroll up” and “Scroll down”. Press “Confirm” to enter the option.
Select “Yes” using “Scroll up” and “Scroll down” and press “Confirm” to save the setting.
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.
Most recent cycle type
Time of most recent cycle
Current date or
date of next day
“Shortcut to
night cycle”
Scroll up Scroll down
Exit and return to
higher menu level
Selection
confirmation
Confirm and return
to previous screen
Exit and return to
higher menu level
Scroll down
Scroll up
SETTINGS icon; press to enter delayed cycle selection screens
START Cycle
icon to launch
delayed cycle
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.
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Page 24
Select the “Connection to PC/Log?” op­tion by pressing the “Scroll up” and “Scroll down” icons. Press “Confirm” to enter the option.
Select “Yes” using the “Scroll up” and
“Scroll down” icons and press the “Con­firm” icon to save the setting.
Select the “RSDATA port selection” op-
tion by pressing the “Scroll up” and “Scroll
down” icons. Press the “Selection confir- mation” icon to enter the option.
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 us-
ing the “Scroll up” and “Scroll down” icons and press the “Confirm” icon to save the
setting.
Scroll up Scroll down
Exit and return to
higher menu level
Selection
confirmation
Scroll down Scroll up
Exit and return to
higher menu level
Selection
confirmation
Scroll up Scroll down
Selection
confirmation
Exit and return to
higher menu level
Confirm and return
to previous screen
Exit and return to
higher menu level
Scroll down
Scroll up
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.
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).
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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.
Selection
confirmation
Scroll down
Scroll up
Exit and return
to higher
menu level
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Once you entered the “Delayed cycle start” op­tion, you will see a list of all available steriliza­tion and test cycles. Select the cycle(s) you want to start delayed by pressing the “Scroll up” and “Scroll down” icons; use the “confirm selection” icon to select, de-select and sort the cycles of your choice. Once set correctly, press the “confirm settings” icon to go to the next screen.
2
2
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.
On this screen the selected cycle(s) is/are shown. Press the "Cycle start" icon to launch the delayed cycle.
The current and the set delayed date and time appear on the screen indicating when the de­layed cycle(s) will start.
Manual stop
Current date
and time
Delayed cycle
date and time
Confirm set-
tings and enter
next screen
Increment
Set time
Decrement
Move next
Set date
Return to pre-
vious screen
Exit and re-
turn to higher
menu level
Scroll up
Scroll down
Confirm set-
tings and enter
next screen
Confirm selection
Return to
previous
screen
Cycle start
Cycle
counter
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).
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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 se- lect “Cycle history” from the menu (see § 6).
Use the “Scroll up” and ”Scroll down” icons to se- lect a cycle you want to view. Press “Confirm” to
view further details of the selected cycle:
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.
Return to
previous
screen
Scroll up
Scroll down
Print cycle
Return to pre-
vious screen
Selection
confirmation
Scroll up
Scroll down
Saved cycles
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)
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Select the counter you wish to reset by pressing
the ”Scroll up” and “Scroll down” icons.
Reset the counter by pressing the “Confirm re-
set” icon.
Confirm by selecting "Yes" or "No" from the
maintenance screen shown aside.
To guarantee an efficient sterilization process and the correct functioning of the steri­lizer, we strongly recommend to follow the maintenance program (see § 11.1).
6.7 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 “Utili- ty” from the menu (see § 6).
Scroll up
Scroll down
Confirm reset
Yes
No
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 reset manually:
6.6 SERVICE
This menu is used for service and diagnostic operations. It can be accessed by authorized service techni­cians only.
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6.7.1 System info
Use this menu to view the sterilizer system information.
Model Serial Number Firmware revision Loader revision Power FW revision
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, the card is ready to be used
Cancel
Confirm
Cancel
Confirm
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.
6.8 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.
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Scroll up Scroll down
Abort and return to
previous screen
Confirm and go
ahead
Abort and return
to previous
Confirm and go
ahead
Scroll down
Scroll up
Abort and return
to previous
screen
Erase the last entry
Move to the
previous position
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.
3) A list of users will be displayed: scroll the list until the ADMINISTRATOR is highlighted and confirm.
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.)
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5) Select the desired option using the scroll buttons and confirm your selection:
1) Modify a user name
2) Change my password
3) Reset a user’s passwords to the default value (0000)
4) Delete a user
5) Add a new user
6) Define the user identification options
Abort and return
to previous
screen
Confirm the choice
and go ahead
Scroll down
Scroll up
Abort and return
to previous
screen
Confirm the choice
and go ahead
Scroll down
Scroll up
Abort and return
to previous
screen
Confirm the choice Scroll down
Scroll up
Abort and return
to previous
screen
Confirm the
changes
Scroll letters down
Scroll letters up
Move to previous position
Move to next position
The letter being
changed is high-
lighted
You can choose the following options:
6.9.2 Modifying a user name
1) Scroll the menu options and select the “Modify user name” option.
2) Select the name of the user to be modified and confirm.
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.
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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
Confirm the choice
Scroll down
Scroll up
Abort and return
to previous
screen
Erase the last entry
Move to the previ-
ous position
Press to continue
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.
2) Enter the new four-digit password.
3) Press the confirmation button to save and exit the function.
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6.9.4 Resetting a user’s password to the default value (0000)
NOTE
The user is now able to set a new password. See section 6.10
Abort and return
to previous
screen
Confirm the choice
Scroll down
Scroll up
Abort and return
to previous
screen
Confirm the choice
Scroll down
Scroll up Press to continue
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.
2) Select the name of the user who needs a new password and confirm.
3) The old password has been deleted and the new password is “0000”. Press the confirmation button to
exit the sub-menu.
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Abort and return
to previous
screen
Confirm the choice Scroll down
Scroll up
Abort and return
to previous
screen
Confirm the choice Scroll down
Scroll up
Abort and return to previous screen
Confirm deleting
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.
2) Select the user to be deleted and confirm
3) Confirm the operation
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6.9.6 Adding a new user
ATTENTION! The new user will be created as soon as the confirmation button is pressed.
Abort and return
to previous
screen
Confirm the choice
Scroll down
Scroll up
Abort and return
to previous
screen
Confirm the name
Scroll letters down
Scroll letters up
Move to pre­vious position
Move to next position or add a space
The letter being
introduced is
highlighted
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.
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.
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NOTES
- The use of passwords can only be activated if the relevant identification option has been activated too.
- The selected user identification options apply to all operators as well as to the admin­istrator.
Abort and return
to previous
screen
Confirm the choice
Scroll down
Scroll up
Accept and return
to previous screen
Tick – untick the highlighted item
Scroll the list down
Scroll the list up
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”.
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.
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 themselves. 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, they 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, they will be asked to enter the secret password If the password is entered incorrectly, no labels will be printed.
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6.10 FUNCTIONS AVAILABLE TO THE OPERATOR(S): PASSWORD
Scroll up
Scroll down
Abort and return
to previous screen
Confirm and go ahead
Abort and return
to previous
screen
Confirm and
go ahead
Scroll down
Scroll up
Abort and return
to previous
screen
Erase the last entry
Move to the
previous position
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.
3) A list of users will be displayed: scroll through the list until your name is highlighted, then press the con­firmation button.
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
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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
Confirm the choice
Abort and return
to previous
screen
Erase the last entry
Move to the
previous position
Press to continue
5) The “Change my password” function is now available: select it by pressing the confirmation button.
6) The password keypad appears. Enter your NEW four-digit password.
7) The following screen will appear: press the confirmation button to continue.
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NOTE
The instructions in this chapter are valid only if the “User Authentication” option is acti­vated. See § 6.8
Abort and return
to previous
screen
Confirm and
go ahead
Scroll down
Scroll up
Abort and return
to previous
screen
Erase the last entry
Move to the previ-
ous position
6.11 STARTING AND ENDING A STERILIZATION CYCLE WITH IDENTIFICATION OF THE USER
6.11.1 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.
- 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.
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Scroll through the list until your name is highlighted and confirm.
- If the “Password at load release” option has been activated, the password keypad will appear. Enter your password.
Abort and return
to previous
screen
Confirm and
go ahead
Scroll down
Scroll up
Abort and return
to previous
screen
Erase the last entry
Move to the
previous position
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.
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
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7. RUNNING A STERILIZATION CYCLE
B UNIVERSAL 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.
B PRION 134
(with ECO-Dry)
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.
-1
2.16
PR DV
LEV End
B-Universal 134
Pressure (bar)
Time
PV1 PV2 PV3PP1 PP2 PPH
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.
Fractionated
pre-vacuum
Holding
time
Pulsed
vacuum drying
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). Note: Certain cycles may have been be de-activated in accordance with local requirements or guidelines
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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
TEST CYCLES
B UNIVERSAL 134
B PRION 134
B UNIVERSAL 121
Helix
B&D
Air leakage
Vacuum test
Sterilization temperature
134°C
134°C
121°C
134°C
--
Sterilization pressure
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'
--
TOTAL CYCLE
DURATION
(including drying
time)
Lisa 517
Small load
22’
Full Load
48’
Small
load
34’
Full
Load
52’
Small load
41’
Full Load
56’
23’
24’
Lisa 522
24’
56’
35’
62’
42’
62’
26’
25’
LOAD TYPE
Full solid (probes,
tweezers, burs,…)
YES
YES
YES
Empty chamber
or test pack
See appendices
6 and 7
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
YES
YES
MAXIMUM LOAD WEIGHT LIMITS:
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, hol-
low 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.
Legend:
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7.1.1 Starting a sterilization cycle
Exit from sleep mode by pressing the "Sleep mode" icon.
Select a cycle by pressing the "Cycle selection" icon and confirm the selection by pressing the "Se­lection confirmation" icon.
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.
NOTE:
If the “user authentication” option is activated, the user will be asked to identify themselves before starting the cycle. If the password protection is activated as well, a password will be requested. See §6.11 for further details.
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.
Enter sleep mode
Menu option
Exit sleep mode
Confirm selection
Cycle selection
Return to
previous menu
Start cycle
7.1.2 ECO-Dry feature
The ECO-Dry feature is active whenever you initiate a sterilization cycle. The feature is designed to always 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 benefit from the shortest cycle time of just over 20 minutes. This feature helps you to save time, energy and money, and works fully automatic.
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In the central part of the screen, a simplified cycle pressure profile is shown. As the cycle proceeds, a progress bar overwrites the completed cycle pressure profile, showing in real time the actual phase the cycle is in. If you press the "Info" icon, further technical parameters are displayed. The "Info" icon can be pressed at any time, also if there is no cycle in progress; it provides important infor­mation especially for service technicians.
7.1.4 End of cycle
Once the cycle is complete, the screen ap­pears as in the image aside.
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.
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 themselves 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.
ATTENTION! Load and trays will be hot at the end of the cycle! Use tray or cassette holders to remove the load.
Info
Unlock door
Info
Cycle
pressure
profile
Progress
bar
Cycle phase
Residual time
Cycle counter
Manual stop
Elapsed
time
Cycle name
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 counter Cycle name
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7.2 MANUAL STOP
If a cycle is 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 is 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.
Manual
stop
Cancel and continue cycle
Confirm
Unlock door
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).
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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
Manual
stop
Info
Scroll-up
Scroll-down
Pause
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).
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:
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7.4 CYCLE DATA SUMMARY
PV
Vacuum pulse (air removal)
PP
Pressure pulse (steam injection)
PPH
Pressure pulse and heating
PR
Process (sterilization/plateau phase)
DV
Vacuum drying
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:
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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
WARNING MESSAGES
Message
Cause
Action
Fill water tank
The clean water tank is empty.
Fill the clean water tank with distilled or demine­ralized water (see § 5.4).
Drain used water
tank
The used water tank is full.
Drain the used water tank (see § 5.5).
Door locking system
problem - Try again
The door could not be locked / unlocked 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
Non conform water
replace water
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.
Unacceptable water
DO NOT run cycle!
According to the sterilizer water conductivity sensor, the water quality (in terms of µS) does not conform to the norm and it may 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.
CPU battery flat
The CPU board battery is worn.
Call for service.
Lost connection with
PC/Log
The sterilizer is unable to establish a con­nection with the computer.
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-
cal filter
This message informs that the bacteriologi­cal 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
water tanks
This message informs that the water tanks need to be cleaned.
Clean the water tanks (see § 11.8).
4000 cycles reached
Call for service
This message informs that a 4000 cycle overhaul needs to be performed.
Call for service.
Message counter
Message
8. DISPLAY MESSAGES
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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.
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.
Yes
No
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.
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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.
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.
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10. ALARM CODE TABLE
Code
Description
Action
Power supply
A010
Power failure or significant drop in voltage occurred during the cycle.
The load cannot be considered sterile. The cycle must be repeated. Check building power supply to the sterilizer.
Sterilization chamber
A100
The time it took to reach the sterilization plateau is too long (overload, leaks, etc.).
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.
A130
During the sterilization phase of the cycle, the pres­sure measured inside the sterilization chamber is above the maximum threshold.
Repeat the cycle. If the problem persists service.
A140
During the sterilization phase of the cycle, the pres­sure measured inside the sterilization chamber 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.
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 broken or disconnected.
service
A240
Fault of the steam generator heater.
service
A250
The internal temperature sensor of the air detector system is broken or disconnected.
service
Refer to the table below for troubleshooting assistance in case the sterilizer generates an alarm code.
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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.
Clean, check or replace the door seal (§11.2) and the face side of the chamber; repeat the cycle. If the problem persists service.
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.
Note: Ensure that the sterilizer chamber is cold and dry when initiating Vacuum Tests!
A390
Leak between the reading points P2 and P3 of the Vacuum Test
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
The “Manual stop” icon was pressed
Wait until the end of the reset phase (see § 7.2).
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11. MAINTENANCE
Before carrying out any maintenance on the unit, remove the mains cable.
Frequency *
# of
cycles*
Operation
Consumable part number
Description
Monthly
50
Clean the door seal and the chamber face side.
§ 11.2
Clean the chamber, the trays and the rack.
§ 0
Clean the chamber filter.
§ 11.4
Clean the external sterilizer surfaces.
§ 11.5
Every 3 months
400
Replace the bacteriological filter.
see
Appendix 9
§ 11.6
Replace the dust filter.
§ 11.7
Every 6 months
800
Clean both water tanks.
-
§ 11.8
Every year
800
Replace the door seal.
see
Appendix 9
§ 11.9
4000
Have the sterilizer serviced by an authorized service technician.
-
§ 11.10
* 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).
Reset the
highlighted
counter
Maintenance
counter
Scroll down
Scroll up
There are two levels of maintenance:
- Maintenance performed regularly by the user.
- Maintenance carried out by authorized service technicians (see § 11.10).
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.
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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.
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 in-
terface 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.
ATTENTION! Operation to be carried out when the sterilization chamber is cold
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.
 
11.2 CLEANING THE DOOR SEAL
11.3 CLEANING THE CHAMBER AND CHAMBER COMPONENTS
11.4 CLEANING THE CHAMBER FILTER
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11.5 CLEANING THE EXTERNAL STERILIZER SURFACES
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 clean-
ing it with detergents or pointed objects.
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
Pull out the filter from the bottom/front of the ste-
rilizer. 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
Disconnect the mains cable. Never use disinfectants or abrasive products. Clean all external covers with a damp cloth and a mild detergent solution.
11.6 REPLACING THE BACTERIOLOGICAL FILTER
11.7 REPLACING THE DUST FILTER
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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 counter-
clockwise 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).
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.
11.8 CLEANING THE WATER TANKS
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).
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11.9 REPLACING THE DOOR SEAL
ATTENTION!
Operation to be carried out when the sterilization chamber is cold
FIRST: top and bottom
THEN: left and right
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
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:
Complete the operation by evenly inserting the seal on the entire circumference.
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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 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
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.
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:
Cleaning:
Checks:
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12. USE OF THE MEMORY CARD
NOTE 1 Periodically transfer cycle data from
the card to your computer.
NOTE 2 The manufacturer does not take re-
sponsibility 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.
Technology
MMC (Multi Media Card)
Tested brands that can be used with the Lisa sterilizer
*PQI-Sandisk-Lexar-Transcend-TwinMos-Toshiba Tested capacity
between 16MB - 1GB
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+
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).
12.1 TECHNICAL CHARACTERISTICS OF THE MEMORY CARD
* 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
* Brands and products are trademarks of the manufacturers
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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.
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.
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
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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. 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. Press the “Confirm” icon to proceed with the formatting.
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
to the main menu.
Confirm
Confirm
Cancel
Confirm
Cancel
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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.
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).
NOTE
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.
Confirm
Confirm
12.10 SAVING A FILE
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13. TROUBLESHOOTING
PROBLEMS
POTENTIAL CAUSES
SOLUTIONS
The sterilizer remains switched OFF.
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 connected.
Plug in the mains cable.
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.
At the end of the cycle, water remains inside the chamber and the load is not perfectly dry.
Countertop not properly le­veled.
The sterilizer must be installed on a level sur­face.
Overloaded chamber.
Comply with the maximum load weight limits for each type of load (§ 7.1). Always use the chamber rack for trays and cassettes.
Chamber filter clogged.
Remove and clean the chamber filter (see §
11.4).
Load incorrectly placed.
Follow the recommendations as listed in Ap­pendix 2.
Oxidation or spots on instruments.
Tap water on instruments when placed in the sterilizer.
Ensure that instruments are dry before they are placed in the sterilizer.
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).
Contact between instruments of different materials.
Ensure that instruments of different materials do not touch (aluminum, carbon or stainless steel, etc.); place them on different trays or cassettes or bag/wrap them.
Scale deposits on the chamber.
Clean the chamber and use water of good quality (see Appendix 7).
Instruments are turning brown or black.
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.
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).
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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.
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APPENDIX 1 TECHNICAL CHARACTERISTICS
Electrical supply:
Single phase 200-240 VAC (±10%); 50/60 Hz; 10 A
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
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
Steam generator:
Power / voltage Max. pressure / max. temperature Safety overload valve
2,000 W / 200 VAC 3 bar / 144°C 3 bar
Sterilization chamber:
Power / voltage Max. pressure / max. temperature Safety overload valve Total volume
Usable space (identical for all cycles) Bacteriological filter
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
Distilled or demineralized water:
Water quality Min. / max. water consumption per cycle
Tank volume
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 re-
quirements
IEC 1010-2-040 Safety requirements for electrical equipment for measurement, control and laboratory use; particular re-
quirements 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 chamber
Name plate on the steam
generator
Name plate on the back of the sterilizer
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Abort and return
to previous
APPENDIX 2 STERILIZATION LOAD PREPARATION
1. 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
Sterilization bags should be placed on trays allowing adequate space
in-between bags.
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Ensure that packs do not touch the sterilizer chamber walls. Place sterilization bags with the paper side facing up.
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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).
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CAUTION: The packet will be hot! For correct interpretation of the test results, refer to the instructions of the
test pack manufacturer.
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
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.
Remove the indicator sheet from the center of the test pack and check the change in colour as ex-
plained below:
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.
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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.
CAUTION: The test will be hot !
For correct interpretation of the test results, refer to the instructions of the test manufacturer.
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.
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.
Remove the indicator strip from the capsule and check the change in colour as explained below:
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.
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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.
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.
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.
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APPENDIX 7 WATER QUALITY
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
The use of water with a conductivity greater than 15µS/cm may affect the steriliza-
tion 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.
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
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.
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APPENDIX 8 EXAMPLE OF A CYCLE DATA REPORT
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APPENDIX 9 ACCESSORIES
DESCRIPTION
ORDERING NUMBER
LisaPrint A70010xx Perforated anodized aluminium tray
F523204x (Lisa 517) F523205x (Lisa 522)
Chamber racks:
Chamber rack
(Europe)
190x43x300/375 *
190x43x300/375 *
190x43x300/375 *
F523008x (Lisa 517) F523009x (Lisa 522)
Chamber rack
(USA)
205x35x300/375 *
205x35x300/375 *
210x35x300/375 *
F523020x (Lisa 517) F523021x (Lisa 522)
Chamber rack
(for 4 cassettes)
190x32x300/375 * 210x32x300/375 * 210x32x300/375 *
190x32x300/375 *
F523012x (Lisa 517) F523015x (Lisa 522)
Chamber rack
(for 2 implant cassettes)
190x70x300/375 *
190x70x300/375 *
F523016x (Lisa 517) F523017x (Lisa 522)
Tray holder F523001x
Drain tube S230900x
Mains cable
U38010xx
Funnel F540903x
Bacteriological filter
W322400x
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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
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APPENDIX 10 HELIX TEST DOCUMENTATION FORM
Date
Cycle
No.
Operator
No.
Released
Yes - No
Signature
Chemical indicator
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 ____________
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