Instructions for Use
80 Pages
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Page 1
Instruction for use
UM009ENG LISA FULLY AUTOMATIC 201 10 REV. 7
Table of Contents 1.
2.
3.
4.
5.
6.
INTRODUCTION................................................................................................................................................... 1 1.1 SCOPE ..............................................................................................................................................................................................1 1.2 FOREWORD .....................................................................................................................................................................................1 1.3 APPLICABLE EUROPEAN DIRECTIVES/NORMS ..........................................................................................................................1 1.4 INTENDED USE ...............................................................................................................................................................................1 1.5 SYMBOLS DISPLAYED ON THE STERILIZER ...............................................................................................................................2 1.6 GENERAL AND SAFETY RECOMMENDATIONS ...........................................................................................................................2 UNPACKING ........................................................................................................................................................ 3 2.1 UNPACKING THE STERILIZER .......................................................................................................................................................3 2.2 STANDARD ACCESSORIES ...........................................................................................................................................................3 UNIT DESCRIPTION ............................................................................................................................................ 4 3.1 FRONT VIEW ....................................................................................................................................................................................4 3.2 SERVICE DOOR ...............................................................................................................................................................................4 3.3 REAR VIEW ......................................................................................................................................................................................5 3.4 DESCRIPTION OF THE INTERNAL WATER TANKS .....................................................................................................................6 3.5 CHAMBER RACK .............................................................................................................................................................................7 3.6 USABLE SPACE IN THE CHAMBER ...............................................................................................................................................7 INSTALLATION .................................................................................................................................................... 8 4.1 SETUP ..............................................................................................................................................................................................8 4.1.1 Securing the sterilizer with a safety bracket ................................................................................. 8 4.2 ELECTRICAL POWER SUPPLY ......................................................................................................................................................9 4.3 PRINTER (optional) ..........................................................................................................................................................................9 4.4 LISAWARE - CONNECTING THE STERILIZER TO A COMPUTER (optional) .............................................................................10 4.4.1 LAN connection ......................................................................................................................... 10 4.4.2 Serial connection ....................................................................................................................... 10 4.5 AUTOMATIC WATER SUPPLY ......................................................................................................................................................11 4.5.1 Connection to the water supply and to the drain ........................................................................ 11 4.5.2 Demineralizer (optional) ............................................................................................................. 11 4.5.3 Drain tube mounting kit with fittings (optional) ........................................................................... 11 GETTING STARTED .......................................................................................................................................... 12 5.1 THE USER INTERFACE .................................................................................................................................................................12 5.2 INITIAL WARNINGS AND SLEEP MODE ......................................................................................................................................13 5.3 DATE-CLOCK SETTING ................................................................................................................................................................13 5.4 FILLING THE CLEAN WATER TANK .............................................................................................................................................14 5.4.1 Manual filling .............................................................................................................................. 14 5.4.2 Automated water supply (optional) ............................................................................................ 14 5.5 DRAINING THE USED WATER TANK ...........................................................................................................................................15 5.5.1 Manual draining ......................................................................................................................... 15 5.5.2 Continuous draining ................................................................................................................... 15 5.6 MEMORY CARD .............................................................................................................................................................................15 5.6.1 Inserting / removing the memory card ....................................................................................... 15 PROGRAMMING ................................................................................................................................................ 16 6.1 SETUP MENU .................................................................................................................................................................................16 6.1.1 Language ................................................................................................................................... 16 6.1.2 Sleep mode................................................................................................................................ 17 6.1.3 Printer ........................................................................................................................................ 17 6.1.4 Label printer ............................................................................................................................... 17 6.1.5 Offset X and Y ........................................................................................................................... 17 6.1.6 Automatic printing ...................................................................................................................... 17 6.1.7 Manual printing .......................................................................................................................... 17 6.1.8 Storage time/weeks ................................................................................................................... 17 6.1.9 User name ................................................................................................................................. 17 6.1.10 Date-Clock setting ..................................................................................................................... 17 6.1.11 Date format ................................................................................................................................ 18 6.1.12 Clock format............................................................................................................................... 18 6.1.13 Brightness .................................................................................................................................. 18 6.1.14 Display backlight ........................................................................................................................ 18 6.1.15 Acoustic tones ........................................................................................................................... 18 6.1.16 Night cycle shortcut ................................................................................................................... 19 6.1.17 Connection to PC/Log ................................................................................................................ 20 6.1.18 RSDATA port selection .............................................................................................................. 20 6.2 TEST CYCLES ................................................................................................................................................................................21 6.3 DELAYED CYCLE START ..............................................................................................................................................................22 6.4 CYCLE HISTORY ...........................................................................................................................................................................23 6.5 MAINTENANCE ..............................................................................................................................................................................24 6.6 SERVICE.........................................................................................................................................................................................24
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6.7
UTILITY ........................................................................................................................................................................................... 24 6.7.1 System info ................................................................................................................................ 25 6.7.2 Formatting the memory card ...................................................................................................... 25 6.8 USER AUTHENTICATION ............................................................................................................................................................. 25 6.9 FUNCTIONS AVAILABLE FOR THE ADMINISTRATOR ............................................................................................................... 26 6.9.1 Access the administrator functions ............................................................................................ 26 6.9.2 Modifying a user name .............................................................................................................. 27 6.9.3 Changing the administrator’s password ..................................................................................... 28 6.9.4 Resetting a user’s password to the default value (0000) ........................................................... 29 6.9.5 Deleting a user........................................................................................................................... 30 6.9.6 Adding a new user ..................................................................................................................... 31 6.9.7 Use of a computer to edit and copy the user list ........................................................................ 31 6.9.8 Setting the user identification options for all users ..................................................................... 32 6.10 FUNCTIONS AVAILABLE TO THE OPERATOR(S): PASSWORD MODIFICATION .................................................................... 34 6.11 STARTING AND ENDING A STERILIZATION CYCLE WITH IDENTIFICATION OF THE USER ................................................ 36 6.11.1 Starting a sterilization cycle ....................................................................................................... 36 6.11.2 End of a sterilization cycle ......................................................................................................... 37 7. RUNNING A STERILIZATION CYCLE .............................................................................................................. 38 7.1 THE AVAILABLE STERILIZATION CYCLES ................................................................................................................................. 38 7.1.1 Starting a sterilization cycle ....................................................................................................... 40 7.1.2 ECO-Dry feature ........................................................................................................................ 40 7.1.3 Cycle in-progress ....................................................................................................................... 41 7.1.4 End of cycle ............................................................................................................................... 41 7.2 MANUAL STOP .............................................................................................................................................................................. 42 7.3 REAL-TIME CYCLE DATA INFORMATION ................................................................................................................................... 43 7.4 CYCLE DATA SUMMARY .............................................................................................................................................................. 44 8. DISPLAY MESSAGES ....................................................................................................................................... 45 9. ALARMS 47 10. ALARM CODE TABLE ....................................................................................................................................... 48 11. MAINTENANCE ................................................................................................................................................. 50 11.1 MAINTENANCE PROGRAM .......................................................................................................................................................... 50 11.2 CLEANING THE DOOR SEAL ....................................................................................................................................................... 51 11.3 CLEANING THE CHAMBER AND CHAMBER COMPONENTS .................................................................................................... 51 11.4 CLEANING THE CHAMBER FILTER ............................................................................................................................................. 51 11.5 CLEANING THE EXTERNAL STERILIZER SURFACES ............................................................................................................... 52 11.6 REPLACING THE BACTERIOLOGICAL FILTER .......................................................................................................................... 52 11.7 REPLACING THE DUST FILTER ................................................................................................................................................... 52 11.8 CLEANING THE WATER TANKS .................................................................................................................................................. 53 11.9 REPLACING THE DOOR SEAL ..................................................................................................................................................... 54 11.10 SERVICE CONDUCTED BY AN AUTHORIZED SERVICE TECHNICIAN .................................................................................... 55 12. USE OF THE MEMORY CARD .......................................................................................................................... 56 12.1 TECHNICAL CHARACTERISTICS OF THE MEMORY CARD ...................................................................................................... 56 12.2 READING OF MEMORY CARD DATA WITH A PC/MAC .............................................................................................................. 56 12.3 MINIMUM HARDWARE REQUIREMENTS FOR A PC/MAC......................................................................................................... 56 12.4 CONNECTING THE EXTERNAL USB CARD READER TO YOUR PC/MAC ............................................................................... 57 12.5 SAVED FILE ................................................................................................................................................................................... 57 12.6 CONTROL CODE ........................................................................................................................................................................... 57 12.7 FILE NAMES ................................................................................................................................................................................... 57 12.8 DIRECTORY NAME ....................................................................................................................................................................... 57 12.9 MEMORY CARD MANAGEMENT .................................................................................................................................................. 58 12.10 SAVING A FILE .............................................................................................................................................................................. 59 13. TROUBLESHOOTING ....................................................................................................................................... 60 14. RECYCLING / DISPOSAL INSTRUCTIONS ...................................................................................................... 61 Appendix 1 TECHNICAL CHARACTERISTICS ................................................................................................... 62 Appendix 2 STERILIZATION LOAD PREPARATION .......................................................................................... 63 Appendix 3 MAINTENANCE OF DENTAL HANDPIECES ................................................................................... 64 Appendix 4 BOWIE AND DICK TEST .................................................................................................................. 65 Appendix 5 HELIX TEST ...................................................................................................................................... 66 Appendix 6 VACUUM TEST ................................................................................................................................. 67 Appendix 7 WATER QUALITY ............................................................................................................................. 68 Appendix 8 EXAMPLE OF A CYCE DATA REPORT .......................................................................................... 69 Appendix 9 ACCESSORIES ................................................................................................................................. 70 Appendix 10 HELIX TEST DOCUMENTATION FORM .......................................................................................... 72
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1.
INTRODUCTION
1.1
SCOPE
The purpose of this user manual is to provide you with information about Lisa 517/522 sterilizers to ensure: • proper installation and set-up. • optimal use. • safe and reliable operation. • compliance with regular maintenance and servicing requirements. NOTE:
1.2
All drawings, images and texts contained in this manual are the property of the manufacturer. All rights reserved. Even partial duplication of drawings, images or text is prohibited. The information contained in this document is subject to change without notice.
FOREWORD
There are two types of users who may operate the sterilizer and who shall read this manual carefully: Administrator The head of the clinic / practice, who is legally responsible for the efficiency of the hygiene protocol in place as well as the sterilization process. He/she is also responsible for the OPERATORS’ training and the correct operation and maintenance of the equipment. Records of attendance at training are maintained, and evidence of understanding demonstrated. 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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1.5
SYMBOLS DISPLAYED ON THE STERILIZER
Consult this table whenever one you see one of these symbols in this manual or on the sterilizer. ATTENTION Where this symbol is displayed on the sterilizer, the user must refer to this document. When shown in the user manual this symbol means ATTENTION IMPORTANT NOTES. To disregard the instructions given in this manual, incorrect use, poor maintenance or servicing by unauthorized personnel, clears the manufacturer of any responsibility for warranty and any other claims. HOT SURFACES This symbol is displayed at the front of the sterilizer beneath the chamber door. It reminds the user to take special care to avoid burns when dealing with the sterilization load, the sterilization chamber, the chamber door and the area around the chamber door.
The material the sterilizer is composed of must be disposed according to the directive 2002/96/CEE.
1.6
GENERAL AND SAFETY RECOMMENDATIONS o
o o o o o o o o o o
The user is responsible for the proper installation, the correct use and maintenance of the sterilizer in accordance with the instructions listed in this manual. For further information call your local service provider. The sterilizer has not been designed for the sterilization of liquids. The sterilizer must not be used in the presence of gas or explosive vapours. The chamber is automatically heating to 120°C as soon as the sterilizer is switched on. The trays and the sterilization load will be hot at the end of each cycle. Use tray or cassette holders to empty the sterilization chamber. Do not exceed the maximum load weight limits as specified in this manual (see § 7.1) Do not remove the name plate or any label from the sterilizer. To avoid electrical short circuits, do not pour water or any other liquid over the sterilizer. Switch off the sterilizer and unplug the mains cable before inspecting, carrying out maintenance or servicing the sterilizer. Repairs, maintenance or service must be carried out by authorized W&H service technicians only with the use of original spare parts. In case of transport:
- Drain both water tanks completely (§ 5.5). - Allow the sterilization chamber to cool down. - Use original or appropriate packaging. Not observing the instructions as specified in this manual can lead to unsafe operation for the user.
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2.
UNPACKING
2.1
UNPACKING THE STERILIZER If the sterilizer had been kept in a place with temperature and humidity different from the installation location, wait for an appropriate time before installing and switching ON the sterilizer. Sterilizers arriving from cold locations could contain moisture, affecting the electrical parts and it could lead to unsafe operation for the user if switched ON immediately. The sterilizer must be removed from the box and transported by two people. Lisa 517: 43.9 kg Total weight: Lisa 522: 46.2 kg NOTE:
2.2
Check the external condition of the box and the sterilizer. In case of any damages, immediately contact your dealer or the shipping agent that has carried out the transport.
STANDARD ACCESSORIES
Following accessories are supplied together with the sterilizer: ACCESSORIES PLACED INSIDE THE STERILIZATION CHAMBER Accessory
Description
Tray
Perforated anodized aluminum tray
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.
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Tray holder
Tray holder for removing trays from the sterilization chamber.
1
Drain tube (manuale drain)
Transparent drain tube with quick connector
1
Tube for drain (continuous drain)
Black tube (length = 3 meters) to install a drain line.
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
line
Quantity
DOCUMENTS PLACED INSIDE THE PACKAGE Sterilization chamber:
1
Sterilizer:
1
User manual
Current user manual
1
Warranty card
Warranty card
1
Norm EN 13060: small steam sterilizers.
1
Declaration of conformity CE
Works Test Report
ACCESSORIES PLACED INSIDE THE PACKAGE Memory card USB reader
External memory card reader
1
Memory card
Reads and saves cycle data
1
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3.
UNIT DESCRIPTION
3.1
FRONT VIEW
Door seal
Water tank cover
Sliding cover for manual filling of the clean water tank
Chamber door
Sterilization chamber
Touch- screen
Door pin Service door Dust filter
3.2
SERVICE DOOR
Bacteriological filter
Connection to unlock the chamber door (service technicians only) Connection for the Air Detector Test Device (optional)
Main switch Memory card slot Quick connector for manual draining of clean water tank Quick connector for manual draining of used water tank
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3.3
REAR VIEW
Male serial port Female serial port
Parallel port (printer)
Circuit breaker (manual reset)
Mains plug socket Safety valve cover Mains cable guide
Test connection
Condenser vent
Air filter
Fitting for an external water supply system Fitting for continuous draining of used water
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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. 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 (4 l) 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 (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 § 4.5). Vent Used water tank
Clean water tank Water level sensors
Water inlet for manual filling of clean water tank
Quick connector for manual draining of clean water tank
Fittings for automatic filling/draining of tanks
Quick connector for manual draining of used water tank
NOTE:
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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 7-11 sterilization cycles.
3.5
CHAMBER RACK Insert the rack into the sterilization chamber, align it at the center/bottom of the chamber and push it gently into position until it clicks. The chamber rack is reversible and can be used for: 5 trays horizontally or 3 cassettes vertically;
or, if inserted in a 90° degree rotated position,
3 trays or 3 cassettes horizontally.
3.6
USABLE SPACE IN THE CHAMBER The chamber usable space is the maximum volume of the chamber for accommodating a sterilization load. This volume is equivalent to a pipe with the following dimensions: Lisa 517 195 x 195 x 297mm (WxHxD); equal to the volume of 11.5 litres
H
Lisa 522 195 x 195 x 390mm (WxHxD); equal to the volume of 15 litres W A
D Ri-
The capacity/volume is identical for all sterilization cycles and types of load.
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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) 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: 55.9 kg (Lisa 517) 59.7 kg (Lisa 522) Leave a gap of 50mm in the back and 10mm on each side of the sterilizer to ensure adequate ventilation. Mount the supplied wall spacers at the back of the sterilizer (see image to the right). Do not place the sterilizer near a sink or in a location where it is likely to be splashed with water - danger of electric short circuit! Install the sterilizer in a well-ventilated room. Keep the sterilizer away from all sources of heat.
4.1.1
Securing the sterilizer with a safety bracket If the bench on which the sterilizer is installed is small, there is a risk of the sterilizer tilting when the chamber door is opened and leaned upon. Use the safety bracket (optional; see Appendix 9) to avoid tilting.
- Move the two front feet in the rear position. - Drill two holes on the installation surface and fix the bracket with the supplied screws. Wall Screws Ø4,8x22
113 Minimum distance (millimeters)
40
2 holes Ø3x20
Refer to safety bracket installation procedures for further details. Position the sterilizer on the bench with one of the rear feet inserted in the safety bracket.
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4.2
ELECTRICAL POWER SUPPLY
The electrical power supply of the sterilizer must comply with all applicable standards in the country of use. The following characteristics are required: - Single - phase 200 - 240 VAC ±10%, 50/60 Hz, 10 A, on a dedicated circuit. - Installation category / mains overload category = II - 10 A differential circuit breaker with a sensitivity of 30 mA. The circuit breaker must be a certified type according to applicable norms. - Maximum power consumption of the sterilizer is 2,000 2,400W (10 A) - A grounded connection is essential. Check that the voltage specified on the name plate located on the backside of the sterilizer corresponds to the supplied mains voltage. The overall electrical safety of the sterilizer is guaranteed only if the mains voltage supply is properly grounded according to all applicable norms. If unclear, have the electrical installation checked by a qualified electrician. Do not plug other equipment into the same socket/circuit. Do not bend or twist the mains cable. Only use the original mains cable as supplied with the sterilizer. Do not use cable extensions.
4.3
PRINTER (optional) We recommend the use of LisaPrint (conforms to the IEC 61010-1 norm) as it has been tested for compatibility with the sterilizer and its software. The use of printers other than the ones listed in the relevant printer setup menu (see 6.1.3) clears the manufacturer of any responsibility for warranty or any other claims.
- Connect the printer cable to the 25-pin parallel port socket at the back of the sterilizer. Cable length should not exceed 2 meters.
- Connect the printer mains cable. - Switch ON the printer. - Select the printer type (§ 6.1.3). LisaPrint is the default setting (Print-p). All necessary data to document sterilization cycles is automatically printed (for details see Appendix 8). NOTE:
Lisa 517/522 sterilizers offer the option to digitally save cycle data on removable memory cards.
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4.4
LISAWARE - CONNECTING THE STERILIZER TO A COMPUTER (optional)
Connect up to four Lisa 517/522 sterilizers to a computer or computer network with LisaWare, a computer software that allows automatic saving of cycle data on a computer and the remote monitoring of the cycle progress on the computer screen. Sterilizers can be connected to a computer in two ways, either via a LAN connection using a MOXA ethernet to serial adaptor, or via a serial connection.
4.4.1
LAN connection W&H recommend using the MOXA NPort 5110 which has been tested and is compatible with the Lisa sterilizer and its software. The use of other ethernet to serial adaptors removes all responsibility from the manufacturer in regards to the correct functioning of the system, the warranty and any other claims.
-
Your sterilizer features two serial ports in the back: male and female; either port can be used for data transfer. Switch on the sterilizer, access the setup menu, enter the “RSDATA port selection” option and select one of the two available serial ports for data transfer (see 6.1.18). - Scroll to the “Connection to PC/Log” option in the setup menu and select and confirm “yes” (see 6.1.17. - Please refer to the MOXA configuration sheet for instructions on how to configure your MOXA NPort 5110 to your network. - Once you have configured your MOXA, use one of the supplied serial cables (F-F and F-M) to connect the MOXA to the serial port you selected for data transfer. - Connect the MOXA to the LAN using an ethernet cable (or if connecting directly to the computer use a cross-wire cable). - Use the supplied cable to connect the MOXA to the mains power supply. For further information, please refer to the “Connection Lisa to LAN or PC” quick-start guide. W&H does not accept any responsibility should the MOXA interfere with the normal functioning of your network.
4.4.2 -
Serial connection
Your sterilizer features two serial ports in the back: male and female; either port can be used for data transfer. Switch on the sterilizer, access the setup menu, enter the “RSDATA port selection” option and select one of the two available serial ports for data transfer (see 6.1.18). - Scroll to the “Connection to PC/Log” option in the setup menu and select and confirm “yes” (see 6.1.17). - 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
AUTOMATIC WATER SUPPLY
Your sterilizer can be connected to an external water supply system and to a continuous drain line. Once connected, the clean water tank will be automatically filled when empty, and the used water will drain continuously. Thus, neither manual filling nor draining are required. The water supply system must deliver demineralized water meeting the requirements as listed in Appendix 7. Do not add any chemical / additive to the water. The manufacturer’s warranty is void if the sterilizer was used with water containing contaminant or chemical levels exceeding those listed in Appendix 7. The water supply system must be fitted with a backflow preventing device complying to IEC 61770. Max. delivered pressure: 8.6 bar Min. flow: 2.5 litres/min.
4.5.1
Connection to the water supply and to the drain Remove the two caps installed on the elbow fittings on the rear side of the sterilizer. Connect the water supply to the D2 port using a 6mm ext/4 mm int. dia. tube (not included). Connect the drain tube to the D4 port using an 8mm ext/6mm int. dia. plastic tube: a 3 meter piece of tube is included in the package.
4.5.2
Demineralizer (optional)
W&H’s Multidem is the water filtration system designed to provide high quality demineralized water for the sterilization process and for all the other needs of the dental practice. Technical data of W&H Multidem: Inlet pressure: between 2 and 8.6 bar Flow 0.25 - 0.5 l/min. Back-syphonage prevention device complying to IEC 61770. Contact your dealer for more information.
4.5.3 Drain tube fittings (optional)
mounting
kit
with
This kit (see image on the left) allows to connect the sterilizer drain tube to an existing drain pipe in a fast and easy way.
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5.
GETTING STARTED
5.1
THE USER INTERFACE To power the sterilizer press the main switch located behind the service door (see image to the left). When the sterilizer is switched ON, the chamber automatically heats to 120°C. This process (pre-heating) takes approximately 10 minutes. If a sterilization cycle is initiated during the pre-heating phase, it will start automatically once the pre-heating temperature is achieved. Once the sterilizer is switched on, the following screen appears: Sleep mode
Menu option
Available cycles
Current time Current date Selection confirmation
Cycle selection
Cycle counter
To run a sterilization cycle, place the load in the sterilization chamber and close the chamber door. Select a cycle by pressing the “Cycle selection” icon and confirm the selection by pressing the “Selection confirmation” icon.
Start cycle
A screen will inform you about the maximum load weight limits for the cycle you selected. Initiate the cycle by pressing the “Start cycle” icon.
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5.2
INITIAL WARNINGS AND SLEEP MODE
This message will appear if the sterilizer is switched on and the clean water tank is empty. Fill the clean water tank with distilled or demineralized water (see § 5.4).
NOTE:
If this message is displayed it is not possible to initiate a sterilization cycle. The message disappears automatically once the clean water tank is filled.
If the sterilizer is not used for a certain programmable time period, it will automatically switch to “Sleep mode” to conserve energy (programmable time-out; default 1 hour; see § 6.1.2). Press the “Sleep mode” icon to get back to the main menu. Sleep mode
5.3
DATE-CLOCK SETTING
To properly save or print cycle data on a memory card or on a printout, the internal sterilizer time and date has to be set since these parameters are included in the sterilization cycle data report. Please refer to § 6.1.10 for details on how to properly set the sterilizer date and time.
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5.4 5.4.1
FILLING THE CLEAN WATER TANK Manual filling Use only high quality distilled or demineralized water meeting the requirements listed in Appendix 7. Do not add any chemical / additive to the water. The manufacturer’s warranty is void if the sterilizer was used with water containing contaminant or chemical levels exceeding those listed in Appendix 7. • • • • • • •
Slide the tank cover to the right to access the clean water tank inlet. Remove the cap (1) from the tank inlet. Insert the funnel and fill the clean water tank with app. 3.5 litres of distilled or demineralized water. Once the clean water tank is almost full, an audible tone will sound; stop filling. Place the cap (1) to close the tank. Slide the tank cover back into its original position. Drain the used water tank (see § 5.5).
The water level in the clean water tank decreases during every sterilization cycle, while the water level in the used water tank is rising. The sterilizer is equipped with an internal water conductivity sensor that constantly monitors the water quality in regards to mineral content. Should the mineral content go beyond a maximum threshold (conductivity >15µS/cm), a warning message is displayed on the screen.
Every time you fill the clean water tank, drain the used water tank (see § 5.5).
5.4.2
Automated water supply (optional) If an automated water supply system is connected to the sterilizer (see § 4.5), the clean water tank 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 on 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. If 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.
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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.
5.5.1
Manual draining • • • •
Open the service door at the front of the sterilizer. Insert the drain tube into the quick connector for the used water (grey connector / right). Drain the used water tank until it is completely empty. Press the push-button on top of the quick connector to dislodge the drain tube. Never reuse water from the used water tank!
5.5.2
Continuous draining
If the permanent drain tube for automated draining of the used water is mounted, the used water tank gets drained automatically. For more information see § 4.5. If the sterilizer is not used for more than 3 days, both water tanks should be completely drained in order to avoid algae growth or any other deposits.
5.6 5.6.1
MEMORY CARD Inserting / removing the memory card Lisa 517/522 sterilizers are equipped with a digital cycle data recording system. Cycle data are written and saved on removable/rewritable memory cards.
- Insert the memory card into the dedicated slot behind the service door until it clicks into its final position. Ensure that the flat corner of the card points to the top/right (see image to the right).
- Periodically remove the memory card to download cycle data to a computer.
- To remove the memory card, slighty push it in and pull it out gently. For further instructions on the use of the memory card, see § 12.
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6.
PROGRAMMING
Lisa 517/522 sterilizers allow the user to program a number of different features. The following section shows step by step how each of these features can be programmed. Press the menu icon to view the list of available options.
The available menu options are shown below:
Menu
6.1
SETUP MENU
The Setup menu permits to set the following options: § 6.1.1 – Language § 6.1.2 – Sleep mode § 6.1.3 – Printer § 6.1.4 – Label printer * § 6.1.5 – Offset X and Y * Exit and return to § 6.1.6 – Automatic printing * higher menu level § 6.1.7 – Manual printing * § 6.1.8 – Storage time * Confirm and § 6.1.9 – User name return to previous menu § 6.1.10 – Date-Clock setting § 6.1.11 – Date format § 6.1.12 – Clock format § 6.1.13 – Display contrast § 6.1.14 – Display backlight § 6.1.15 – Acoustic tones § 6.1.16 – Night cycle shortcut § 6.1.17 – Connection to PC/Log § 6.1.18 – RSDATA port selection
Scroll up Current selection
Scroll-down
* The sub-menus related to label printing are only available when the label printer LisaSafe is connected.
6.1.1
Scroll up
Language
Use this menu to select the user interface language.
Exit and return to higher menu level
Confirm and return to previous menu
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Current selection
Scroll down
6.1.2
Sleep mode
In “Sleep mode” the sterilizer reduces the power consumption to a minimum. The sterilizer will switch to sleep mode whenever it is idling without being used. Use this menu to program the time before the sterilizer automatically switches to sleep mode. The time range is from 0 (never in sleep mode) to 8 hours. The factory setting is 1 hour.The time can be set in fixed increments of 10 minutes.
6.1.3
Printer
Use this menu if you want to connect a printer for cycle data recording. Select the printer by using the scroll icons, press “Confirm” to save the configuration. For more information on connecting a printer to your sterilizer, see § 4.3.
6.1.4
Label printer
6.1.5
Offset X and Y
6.1.6
Automatic printing
6.1.7
Manual printing
6.1.8
Storage time/weeks
6.1.9
User name
Exit and return to higher menu level
Confirm and return to previous menu
Exit and return to higher menu level Confirm and return to previous menu
Increase time
Decrease time
Scroll up
Current selection
Scroll down
These menu items are available only if a LisaSafe label printer is connected. Refer to the LisaSafe user manual for a description of these commands.
Exit and return to Use this menu to program the user or the higher menu level office name. The name will be included in the cycle data report. Select a character by User or office name pressing the ”Increment” or “Decrement” icons. Press the “Move next” icon to move to the next Confirm and return to previous menu position. When the setting is completed, press the “Confirm” icon.
Increment
Move next
Decrement Move previous
6.1.10 Date-Clock setting Use this menu to set the internal time and date of the sterilizer. It is important to set these parameters as they are included in the cycle data report. Select a character by pressing the ”Increment” or “Decrement” icons. Press the “Move next” icon to go to the next position. When the setting is completed, press the “Confirm” icon.
Exit and return to higher menu level Date Confirm and return to previous menu
Increment Time Move next Decrement Move previous
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6.1.11 Date format Use this menu to change the date format. Press the “Scroll up” and “Scroll down” icons to select the format. Press the “Confirm” icon to save the selection.
Exit and return to higher menu level
Scroll up
Confirm and return to previous screen Scroll down
6.1.12 Clock format Use this menu to change the clock format. Press the “Scroll up” and “Scroll down” icons to select the format. Press the “Confirm” icon to save the selection.
Exit and return to higher menu level
Scroll up
Confirm and return to previous screen Scroll down
6.1.13 Brightness Use this menu to change the screen contrast for a better visualization in regards to the surrounding environment. Press the “Increase contrast” and “Decrease contrast” icons to adjust the contrast. Press the “Confirm” icon to save the selection.
6.1.14 Display backlight Use this menu to adjust the screen backlight. Press the “Increment” and “Decrement” icons to change the setting. Press the “Confirm” icon to save the selection.
Exit and return to higher menu level
Increase
Confirm and return to previous screen Decrease
Exit and return to higher menu level
Increase
Confirm and return to previous screen Decrease
6.1.15 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.
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Exit and return to higher menu level
Scroll up
Confirm and return to previous screen Scroll down
6.1.16 Night cycle shortcut If you frequently use the delayed cycle start option (see § 6.3) you can activate an icon on the main screen (cycle selection screen) that will serve as a shortcut to the delayed cycle start submenu.
Select the “Night cycle shortcut” option by pressing ”Scroll up” and “Scroll down”. Press “Confirm” to enter the option.
Exit and return to higher menu level
Scroll up
Selection confirmation Scroll down
Select “Yes” using “Scroll up” and “Scroll down” and press “Confirm” to save the setting.
Exit and return to higher menu level
Scroll up
Confirm and return to previous screen
Scroll down
Once you have selected the shortcut option, a shortcut icon will appear on the main screen (cycle selection screen; see picture to the right). Note: The shortcut icon will only appear if you have used the delayed cycle start function at least once in the past.
Whenever you wish to use the delayed cycle start function, press the shortcut to night cycle icon. You will access a screen showing your most recent settings for delayed cycle start cycle type and time/date. Note: The suggested date will be set by default to either the current day or the next day, depending on your past programming pattern. If you wish to modify any of the default settings, press the “Settings” icon. This will send you to the delayed cycle selection screens. Please refer to § 6.3 for further information. To launch the delayed cycle, press the “start cycle” icon.
“Shortcut to night cycle”
Time of most recent cycle Current date or date of next day
START Cycle icon to launch delayed cycle
Most recent cycle type
SETTINGS icon; press to enter delayed cycle selection screens
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6.1.17 Connection to PC/Log Use this menu if you want your sterilizer to communicate with a computer in conjunction with the LisaWare software package. For further details please see § 4.4.
Select the “Connection to PC/Log?” option by pressing the “Scroll up” and “Scroll down” icons. Press “Confirm” to enter the option.
Exit and return to higher menu level
Scroll up
Selection confirmation Scroll down
6.1.18 RSDATA port selection Use this menu to allocate one of the rear serial ports for data transfer to your computer in conjunction with the LisaWare software package (see § 4.4).
Select the “RSDATA port selection” option by pressing the “Scroll up” and “Scroll down” icons. Press the “Selection confirmation” icon to enter the option.
Exit and return to higher menu level
Scroll up
Selection confirmation Scroll down
There are two serial ports for data transfer fitted in the back of the sterilizer. Looking at the sterilizer from the back, the serial port on the right side is of a female type (RS232), whereas the port on the left is of a male type (RS232). Any of the two ports can be used for data transfer; the LisaWare package includes both male and female cables. Select the serial port you wish to allocate for data transfer using the “Scroll up” and “Scroll down” icons and press the “Confirm” icon to save the setting.
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Scroll up Exit and return to higher menu level
Selection confirmation Scroll down
6.2
TEST CYCLES
Use this menu to run a variety of test cycles that might be mandatory in your country. Press the "Menu" icon on the main screen and select "Test cycles" from the menu (see § 6). Select the Test cycle by pressing the ”Scroll up” and “Scroll down” icons and initiate the cycle by pressing the "Selection confirmation" icon. For more information on test cycles see appendices 3-5.
Exit and return to higher menu level
Scroll up
Selection confirmation Scroll down
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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 § 6.1.16). Once you entered the “Delayed cycle start” Scroll up Exit and return to option, you will see a list of all available higher menu sterilization and test cycles. Select the cycle(s) level you want to start delayed by pressing the “Scroll up” and “Scroll down” icons; use the Scroll down Confirm “confirm selection” icon to select, de-select and settings and enter next sort the cycles of your choice. screen Once set correctly, press the “confirm settings” Confirm selection icon to go to the next screen. Set the date and time of the delayed cycle start by pressing the “Increment” or “Decrement” icons. Press the “Move next” icon to go to the next character. When the setting is completed, press the “Confirm” icon to go to the next screen.
Return to previous screen
Increment
Confirm settings and enter next screen
Set time
Decrement Move next
On this screen the selected cycle(s) is/are shown. Press the "Cycle start" icon to launch the delayed cycle.
Return to previous screen Cycle start Cycle counter
Manual stop
The current and the set delayed date and time appear on the screen indicating when the delayed cycle(s) will start.
Current date and time Delayed cycle date and time
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6.4
CYCLE HISTORY
Use this menu to view cycle data of the most recent 100 sterilization and/or test cycles. Cycle data is recorded on the main CPU board on a “first in – first out” basis. Press the “Menu” icon on the main screen and select “Cycle history” from the menu (see § 6).
Return to previous screen
Scroll up
Saved cycles
Selection confirmation Return to previous screen
Scroll down Scroll up
Use the “Scroll up” and ”Scroll down” icons to select a cycle you want to view. Press “Confirm” to view further details of the selected cycle: Print cycle
Scroll down
It is possible to print or save this data by selecting the appropriate icons: prints the cycle report (only if a printer is connected to the sterilizer; see § 4.3 and 6.1.3) saves the cycle report on the memory card prints cycle labels (only if a LisaSafe label printer is connected to the sterilizer; see § 6.1.4)
If you have several accessories connected to your sterilizer, more icons will be available (see aside).
If more than two options are active, a selection key appears to allow you to select the desired icon and action.
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6.5
MAINTENANCE
Certain consumables have to be replaced periodically to guarantee a faultless operation of the sterilizer. Display messages will inform you whenever it is time to replace one of those components (see § 8). Press the "Menu" icon on the main screen and select "Maintenance" from the submenu (see § 6). Use this menu to view the number of cycles remaining before it is time to replace the: • bacteriological filter (every 400 cycles) • dust filter (every 400 cycles) • door seal (every 800 cycles) • or perform a general service by a qualified technician (every 4000 cycles) The 4 counters decrease in value after each cycle. When one of the counters reaches 0, the corresponding message appears on the touch-screen (see § 8). In case a consumable gets replaced before the respective counter has reached 0, the counter has to be Scroll up reset manually: • Select the counter you wish to reset by pressing the ”Scroll up” and “Scroll down” icons. • Reset the counter by pressing the “Confirm reset” icon. • Confirm by selecting "Yes" or "No" from the maintenance screen shown aside. Confirm reset
Scroll down
Yes
No
To guarantee an efficient sterilization process and the correct functioning of the sterilizer, we strongly recommend to follow the maintenance program (see § 11.1).
6.6
SERVICE
This menu is used for service and diagnostic operations. It can be accessed by authorized service technicians only.
6.7
UTILITY
Use this menu to view the sterilizer system information and to format the memory card. Press the “Menu” icon on the main screen and select “Utility” from the menu (see § 6).
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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
6.7.2
Formatting the memory card
Use this menu to format your memory card in case you want to erase all the data on the card. Press the “Menu” icon on the main screen and select “Utility” from the menu (see § 6). Press “Format MMC” to initiate the formatting. The system first verifies the card. Next you will see this screen asking if you want to format the card. Press "Confirm" to proceed with the formatting or "Cancel" to exit the formatting menu. If you confirm to proceed with formatting, all data will be lost on the card. Press “Cancel” to exit the formatting menu. Once the formatting is completed, Confirm the card is ready to be used
6.8
Confirm
Cancel
Cancel
USER AUTHENTICATION
W&H Lisa 517/522 sterilizers, in combination with the optional LisaSafe package for label printing, provide an ultra-safe traceability concept in an extremely user-friendly way. They provide the following options, all separately selectable: • Management of multiple users by the Administrator (dentist) • Identification via user name and saving of the user who has started the cycle • Password-protected cycle start once the user has been identified • Identification via user name and saving of the user who has released the load • Password-protected load release once the user has been identified • Printing of bar-code labels containing the name of the user who has released the load • Inhibition of label printing if the cycle has not completed successfully (alarm, cycle interruption etc.) so as to avoid all human error • Easy management and access to all traceability options directly from the sterilizer touch-screen.
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6.9 6.9.1
FUNCTIONS AVAILABLE FOR THE ADMINISTRATOR Access the administrator functions
To access the ADMINISTRATOR functions: 1) Press the “Menu” icon on the main screen that appears when the unit is switched ON.
2) Scroll the options until the “User authentication" option is highlighted and confirm. Abort and return to previous screen
Scroll up
Confirm and go ahead
Scroll down
3) A list of users will be displayed: scroll the list until the ADMINISTRATOR is highlighted and confirm. Abort and return to previous
Scroll up
Confirm and go ahead
Scroll down
4) Enter the secret password to gain access to the ADMINISTRATOR functions. (The default password for the Administrator (and for any new user) is 0000.) Abort and return to previous screen
Move to the previous position
Erase the last entry
26
5) Select the desired option using the scroll buttons and confirm your selection: You can choose the following options: Abort and return 1) Modify a user name to previous 2) Change my password screen 3) Reset a user’s passwords to the default value (0000) 4) Delete a user Confirm the choice and go ahead 5) Add a new user 6) Define the user identification options
6.9.2
Scroll up
Scroll down
Modifying a user name
1) Scroll the menu options and select the “Modify user name” option. Abort and return to previous screen
Confirm the choice and go ahead
Scroll up
Scroll down
2) Select the name of the user to be modified and confirm. Abort and return to previous screen
Scroll up
Confirm the choice Scroll down
3) Select the letter(s) to be modified using the PREVIOUS and NEXT position buttons. Use the SCROLL UP and SCROLL DOWN buttons to select the correct letter. Once finished, confirm the changes: this will save the changes and exit the menu. Abort and return to previous screen
Scroll letters up
The letter being changed is highlighted Confirm the changes
Scroll letters down Move to next position
Move to previous position
27
6.9.3
Changing the administrator’s password
The default password for the Administrator (and for any new user) is 0000. To change the Administrator’s password proceed as follows: 1) Scroll through the menu options and select the “Change my password” option and confirm. Abort and return to previous screen
Scroll up
Confirm the choice Scroll down
2) Enter the new four-digit password.
WARNING! The password is saved as soon as the fourth digit has been entered. If you are unsure of the sequence you have entered, DO NOT EXIT THE FUNCTION and repeat the procedure.
Abort and return to previous screen
Move to the previous position Erase the last entry
3) Press the confirmation button to save and exit the function.
Press to continue
WARNING! If the Administrator’s password gets lost or forgotten, please contact technical service.
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6.9.4
Resetting a user’s password to the default value (0000)
Use this function if a user has lost or forgotten his/her own password: it can be reset to "0000" so that the user can then enter with “0000” and save a new valid password. To reset a user’s password proceed as follows: 1) Scroll through the menu and select the “Reset password (0000)” option and confirm. Abort and return to previous screen
Scroll up
Confirm the choice Scroll down
2) Select the name of the user who needs a new password and confirm. Abort and return to previous screen
Scroll up
Confirm the choice Scroll down
3) The old password has been deleted and the new password is “0000”. Press the confirmation button to exit the sub-menu.
Press to continue
NOTE
The user is now able to set a new password. See section 0
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6.9.5
Deleting a user
To delete the name of a user who no longer uses the sterilizer, proceed as follows: 1) Scroll through the menu options and select the “Delete user” option. Abort and return to previous screen
Scroll up
Confirm the choice Scroll down
2) Select the user to be deleted and confirm Abort and return to previous screen
Scroll up
Confirm the choice Scroll down
3) Confirm the operation
Confirm deleting
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Abort and return to previous screen
6.9.6
Adding a new user
This function allows to create a new user who is permitted to operate the sterilizer. 1) Scroll through the menu options, select the “Add new user” option and confirm. Abort and return to previous screen
Scroll up
Confirm the choice
Scroll down
2) Enter the user name using the UP and DOWN buttons to select the correct letter, and PREVIOUS and NEXT buttons to move along the character positions. Once entered correctly, confirm the changes. Abort and return to previous screen
Scroll letters up
The letter being introduced is highlighted
ATTENTION! The new user will be created as soon as the confirmation button is pressed.
Scroll letters down
Confirm the name
Move to previous position
6.9.7
Move to next position or add a space
Use of a computer to edit and copy the user list
Editing the user list (adding, deleting, changing a user name) is also possible from a computer. Ask your ® Dealer for a special Microsoft Excel spreadsheet, which also permits copying and transferring the user list from a sterilizer to another.
31
6.9.8
Setting the user identification options for all users
Depending on the organization of the practice and the traceability requirements, the ADMINISTRATOR can set the following options: • - Identification and saving of the operator who has started the cycle; • - Password-protected cycle start once the operator has been identified; • - Identification and saving of the operator who has released the load; • - Password-protected load release and label printing once the operator has been identified. 1) Scroll through the menu options and select “User Identification options”. Abort and return to previous screen
Scroll up
Confirm the choice Scroll down
2) The following screen will appear. Use the UP and DOWN buttons, and activate / deactivate each option with the TICK button. The “ ” symbol confirms that the option has been activated. Accept and return to previous screen
Scroll the list up
Tick – untick the highlighted item Scroll the list down
The following options can be activated: - User name at cycle start: When the cycle has been selected and is started, the user will be asked to identify 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. NOTES
If the user does not identify him/herself at the end of the cycle, or if the password is incorrect, the name will not be printed on the traceability labels.
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.
32
- Load/test cycle confirmation This option allows to keep trace both of the sterilization cycles whose load was not accepted, and of the test cycles. a) Case of a sterilization cycle: If this option is activated, at the end of the cycle the following screen will appear, asking for confirmation that the load is accepted or not.
Accept the load
Refuse the load
If the load is not accepted, the name of the user who rejected the load is stored in memory. Through the “Cycle history” menu the name of the user who rejected the load can be displayed, and the cycle labels, showing that the load was not accepted, can be printed. b) Case of a test cycle: If this option is activated, the following screen will appear, asking for confirmation that the test was satisfactory or not.
The test is accepted
The test is not accepted
The name of the user who judged the test outcome (either acceptable or unacceptable) is stored in memory, and can be displayed through the “Cycle history” menu.
33
6.10 FUNCTIONS AVAILABLE TO THE OPERATOR(S): PASSWORD MODIFICATION Proceed as follows: 1) Press the “Menu” icon on the main screen that appears when the unit is switched ON.
2) Scroll the menu options and select the “User authentication” option. Abort and return to previous screen
Scroll up
Abort and return to previous screen
Scroll down
3) A list of users will be displayed: scroll through the list until your name is highlighted, then press the confirmation button. Confirm and go ahead Scroll up
Confirm and go ahead
Scroll down
4) You will then be asked to enter your OLD password. If you are inserting a password for the first time, or after it has been reset to the default, the password is 0000 Abort and return to previous screen
Move to the previous position
Erase the last entry
34
5) The “Change my password” function is now available: select it by pressing the confirmation button.
Abort and return to previous screen
Confirm the choice
6) The password keypad appears. Enter your NEW four-digit password. WARNING! The password is saved as soon as the fourth digit has been entered. If you are unsure of the sequence you have entered, DO NOT EXIT THE FUNCTION and repeat the procedure.
Abort and return to previous screen
Move to the previous position
Erase the last entry
7) The following screen will appear: press the confirmation button to continue.
Press to continue
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6.11 STARTING AND ENDING A STERILIZATION CYCLE WITH IDENTIFICATION OF THE USER NOTE
The instructions in this chapter are valid only if the “User Authentication” option is activated. See § 6.8
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. Abort and return to previous screen
Scroll up
Confirm and go ahead
Scroll down
- If the “Password at cycle start” option has been activated, the password keypad will appear. Enter your password to start the sterilization cycle. The name of the user that launched the cycle will be saved.
Abort and return to previous screen
Move to the previous position Erase the last entry
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6.11.2 End of a sterilization cycle At the end of a cycle when the door is opened, if the “User name at load release” option has been activated, a list of all authorized users will appear. Scroll through the list until your name is highlighted and confirm. Scroll up
Abort and return to previous screen
Confirm and go ahead
Scroll down
- If the “Password at load release” option has been activated, the password keypad will appear. Enter your password. Abort and return to previous screen
Move to the previous position
Erase the last entry
The name of the user who released the load will be saved and printed on the cycle report. If the LisaSafe (optional label printer) is connected and the label printing option is activated, the name of the user who released the load will be printed on the load identification labels
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7.
RUNNING A STERILIZATION CYCLE
7.1
THE AVAILABLE STERILIZATION CYCLES
The following table shows the available sterilization cycles and the different type of loads that can be processed in the sterilizer. In total there are 3 type B sterilization cycles available; all offering the ECO-DRY feature (see below). Note: Certain cycles may have been be de-activated in accordance with local requirements or guidelines
B UNIVERSAL 134 (with ECO-Dry)
B PRION 134 (with ECO-Dry)
This is the factory setting default sterilization cycle of the sterilizer (a different default cycle can be set by the user). The cycle is a type B sterilization cycle (suitable for all types of loads; solid, porous, hollow A and B; unwrapped, bagged, single or double wrapped) that features a pre-vacuum phase, a plateau time (sterilization or holding time) of 4 minutes at a temperature of 134°C and a pulsed vacuum drying phase. See the table on the following page for further details. This is a special sterilization cycle in accordance with the WHO’s recommendations on CJD (Creutzfeld Jakob Disease) for a longer sterilization plateau. The cycle is a type B sterilization cycle (suitable for all types of loads; solid, porous, hollow A and B; unwrapped, bagged, single or double wrapped) that features a pre-vacuum phase, a plateau time (sterilization or holding time) of 18 minutes at a temperature of 134°C and a pulsed vacuum drying phase. See the table on the following page for further details.
B UNIVERSAL 121
This is a low-temperature sterilization cycle (121°C) primarily designed to sterilize items that cannot withstand the temperature of 134°C (plastics, textiles). The cycle is a type B sterilization cycle (suitable for all types of loads; solid, porous, hollow A and B; unwrapped, bagged, single or double wrapped) that features a plateau time (sterilization or holding time) of 15 minutes at a temperature of 121°C and a pulsed vacuum drying phase. See the table on the following page for further details.
ECO-Dry FEATURE
When selecting a “B-UNIVERSAL 134” or a “B-PRION 134” cycle, the sterilizer automatically adjusts the time of the drying phase to the amount of load placed, thus delivering the shortest cycle duration possible at all times. For further details see § 7.1.2.
2.16
Pressure (bar)
B-Universal 134
All available sterilization cycles feature the same pressure profile as shown in the graph aside. Only the duration of the sterilization time (or holding time), drying time and the sterilization temperature change.
Time
-1
PV1
PP1 PV2 PP2 PV3
Fractionated pre-vacuum
38
PPH
PR
Holding time
DV
Pulsed vacuum drying
LEV
End
Legend: PV1 – PV3
Vacuum pulse (removal of air from the sterilization chamber/load)
PP1 - PP2
Pressure pulse (steam injection)
PPH
Pressure pulse and heating (steam injection and heating to sterilization temp.)
PR
Process (plateau/sterilization/holding time)
DV
Vacuum drying
SEP
Water separator draining phase
LEV
Leveling
STERILIZATION CYCLES
TEST CYCLES
B UNIVERSAL 134
B PRION 134
B UNIVERSAL 121
Helix B&D
Air leakage Vacuum test
134°C
134°C
121°C
134°C
--
2.16 bar
2.16 bar
1.16 bar
2.16 bar
-0.87bar
Sterilization temperature Sterilization pressure Duration of the plateau phase
4'
18'
15'
3'30
10'
Duration of the drying phase
5-16'
5-16'
20'
4'
--
23’
17’
26’
18’
LOAD TYPE
TOTAL CYCLE DURATION (including drying time)
Small load
Full Load
Lisa 517
20’
46’
Lisa 522
23’
52’
Full Load
34’
60’
37’
66’
Small load
Full Load
41’
56’
42’
62’
Full solid (probes, tweezers, burs,…)
YES
YES
YES
Small porous items (gauze, cotton,…)
YES
YES
YES
Full porous (80% of the usable space).
YES
YES
YES
Hollow A (hand pieces, forceps, scissors,)
YES
YES
YES
Hollow B (vacuum tips,…)
YES
YES
YES
Unwrapped, bagged, single/double wrapped
YES
YES
YES
MAXIMUM LOAD WEIGHT LIMITS: •
Small load
Empty chamber or test pack See appendices 6 and 7
Lisa 517: 4.5 kg solid items / 1.5 kg porous items Lisa 522: 6.0 kg solid items / 2.0 kg porous items
Total type-B concept: All available sterilization cycles can sterilize and dry all types of loads: full solid, porous, hollow A, hollow B, plastics, rubber, etc.; unwrapped, bagged, single or double wrapped, but :
•
For preparation of the load, follow the instructions provided by the instrument manufacturer.
•
For guaranteed sterilization, stay within the maximum load weight limits as specified in this table.
Using the sterilizer with a load type different from the one given in the table above or bigger than specified in the table above could result in non-sterile conditions at the end of the cycle and expose people to the hazard of cross-infections. The indication of sterile load given on the display at the end of the cycle is not valid if the type and quantity of the load are not complied.
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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.
Return to previous menu
Start cycle
NOTE:
7.1.2
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.
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.
NOTE:
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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.
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 • Cycle name Info In the central part of the screen, a simplified Manual stop cycle pressure profile is shown. As the cycle proceeds, a progress bar overwrites the Progress bar completed cycle pressure profile, showing in Cycle real time the actual phase the cycle is in. phase Cycle If you press the "Info" icon, further technical pressure parameters are displayed. The "Info" icon profile can be pressed at any time, also if there is no cycle in progress; it provides important Residual Elapsed information especially for service technicians. time time
7.1.4
End of cycle
Once the cycle is complete, the screen Unlock door appears as in the image aside.
Cycle counter Info
To unlock the door press the “Unlock door” icon. To view the parameters of the last cycle press the “Info” icon before unlocking the door.
ATTENTION! • Load and trays will be hot at the end of the cycle! Use tray or cassette holders to remove the load. • Do not leave the door ajar if the chamber is hot. This will prevent concentration of heat in the chamber door area.
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 him/herself 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.
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7.2
MANUAL STOP
A sterilization cycle in progress can be aborted manually at any time by pressing the manual stop icon. Once pressed, a warning screen will appear asking for a confirmation (see image below, top right). If the manual stop is confirmed, the alarm code A990 (see picture below) is displayed, and a two-minute reset phase starts to drain the pneumatic circuits and to depressurize the chamber (see image below, bottom left). Do not switch off or unplug the sterilizer during this reset phase! At the end of this phase, the door can be unlocked by pressing the "Unlock door" icon (see image below, bottom right). Manual stop
Confirm
Cancel and continue cycle
Unlock door
If a cycle 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.
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7.3
REAL-TIME CYCLE DATA INFORMATION
Press the “Info” icon at any time during the sterilization cycle or when the sterilizer is idling to view a list of the most important technical parameters of the unit (see screen below, right). Scroll-up Info
Pause Scroll-down
The INFO screen is controlled by an automatic timeout. Press the “Pause” icon to prevent the screen from automatically returning to the previous screen. See the table below for a description of the displayed technical parameters: Legend: P chamber
Pressure/vacuum inside the sterilization chamber
T° Theo. Chamber
Theoretical temperature calculated from chamber pressure
T° Chamber ext
Temperature of the chamber external heater (jacket)
T° steam gen
Temperature of the steam generator heating element
T° air detector
Temperature of the air detector
Power Steam gen
Power consumption of steam generator
Power chamber heat
Power consumption of the chamber external heater (jacket)
T° Condenser
Temperature of the condenser
Conductivity H20
Water conductivity
H20
Water volume pumped inside the steam generator
F0
F0 value
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7.4
CYCLE DATA SUMMARY
Press the "Info" icon at the end of a cycle before unlocking the chamber door (see image below, left) to view a summary of the cycle parameters (see images below, middle and right).
The information screen lists the following parameters: • Cycle name • Cycle counter • Time/duration, pressure and temperature readings at the end of each cycle phase. • Temperature and pressure readings of the actual sterilization/plateau phase. Legend:
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PV
Vacuum pulse (air removal)
PP
Pressure pulse (steam injection)
PPH
Pressure pulse and heating
PR
Process (sterilization/plateau phase)
DV
Vacuum drying
8.
DISPLAY MESSAGES
Once the sterilizer is switched on, a variety of messages can appear on the touch-screen. Messages show the status of the sterilizer; an example is shown aside. A message counter indicates the number of messages pending (e.g., message 01/02). Messages are divided into three main categories: • Warning messages • Information messages • Maintenance messages Check the table below for instructions on how to respond to the various messages
Message counter
Message
WARNING MESSAGES Message Fill water tank Drain used water tank
Cause
Action
The clean water tank is empty.
Fill the clean water tank with distilled or demineralized water (see § 5.4).
The used water tank is full.
Drain the used water tank (see § 5.5).
Door locking system The door could not be locked / unlocked problem - Try again properly.
Check (clean) the door seal and try again. Call for service if the message persists.
Note: When these messages appear on the screen, the cycle selection command is disabled. It is not possible to initiate a cycle until the necessary action is carried out. INFORMATION MESSAGES 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.
The CPU board battery is worn.
Call for service.
CPU battery flat
Lost connection with The sterilizer is unable to establish a PC/Log 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 bacteriological 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 This message informs that the water tanks water tanks need to be cleaned.
Clean the water tanks (see § 11.8).
4000 cycles reached This message informs that a 4000 cycle Call for service overhaul needs to be performed.
Call for service.
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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.
•
The "Reset counter" function allows the user to postpone the necessary action (e.g. when the consumable part to be replaced is not available). If you press the “Yes” icon, the maintenance message will disappear and the maintenance counter will be reinitialized. If you press the “No” icon, the maintenance message will reappear after five cycles and the counter will keep counting up.
Yes
No
Lisa sterilizers must be maintained according to the maintenance program (see § 11.1). Inadequate or inappropriate maintenance can lead to frequent malfunctions and expensive repairs and may void the manufacturer’s warranty.
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9.
ALARMS
Lisa sterilizers constantly monitor a variety of parameters during the sterilization cycle to assure a proper sterilization of the load. In case any of the parameters are off, potentially affecting the sterilization efficiency, the cycle is immediately interrupted and an alarm message is displayed.
Once the sterilizer generates an alarm message, a twominute reset phase starts to drain the pneumatic circuits and depressurizes the chamber. Do not switch off or unplug the sterilizer during this reset phase!
At the end of the reset phase, the door can be unlocked by pressing the “Unlock door” icon. The screen will display the type of alarm that was generated and indicate the condition of the sterilization load. Refer to § 10 for alarm-code troubleshooting.
If an alarm message is generated before the sterilization/plateau phase (PR) of the sterilization cycle is completed, the following message will be displayed: !! Load not sterile !! If an alarm message is generated after the completion of the sterilization/plateau phase of the sterilization cycle (e.g., during the drying phase), the following message will be displayed: !! Sterile conditions achieved, drying interrupted !! Both messages are printed or saved on the memory card.
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