User Manual Water Steam Sterilizer LISA MB17/22 201 10 AEN REV.
SUMMARY 1. UNPACKING 1.1. 1.2. 2. SET-UP 2.1. 2.2. 2.3. 3. 4.6. 4.7. 4.8. 4.9. Main menu Description of the water tank Filling of the main water tank Draining of the used water tank Programming 4.5.1. Selecting a language 4.5.2. Programming the name of the doctor / surgery 4.5.3. Programming the date and time 4.5.4. Programming the printer 4.5.5. Adjusting the brightness of the touch screen 4.5.6. Programming the stand-by mode 4.5.7. Maintenance program 4.5.8. Service program CYCLE SELECTION 4.6.1.
RECOMMENDATIONS – SAFETY The purpose of this user manual is to provide you with all the information you need in order to ensure: ព A proper installation and set-up. ព Optimal use. ព A safe and reliable operation. ព A regular and correct servicing requirements. DECLARATION OF CONFORMITY The Lisa sterilizer MB 17/22 is a Medical device class IIb, in accordance with rule 15 - Appendix IX of the European Directive 93/42/CEE.
GENERAL RECOMMENDATIONS – SAFETY The user is responsible for operating and servicing the sterilizer in accordance with the instructions listed in this manual. The sterilizer has not been designed for the sterilisation of liquids. The sterilizer has not been designed to operate in the presence of gas or explosive vapours. The chamber is automatically heated to 110°C as soon as the sterilizer is switched on. The trays and the load will still be hot at the end of each cycle.
1. UNPACKING The sterilizer, the accessories, the user manual and the warranty card are supplied in a sturdy box. Check the condition of the packaging on receipt. Contact the carrier immediately and inform your supplier if the outer packaging is damaged. 1.1.
1.2. UNPACKING THE ACCESSORIES Open the door and remove the accessories from the sterilization chamber. Check the contents: 5 anodised aluminium trays Reversible rack for 3/5 trays Tray holder Drain tube Mains cable Funnel User manual and warranty card Declaration of conformity 1 2 4 6 3 5 7 Insert the rack into the sterilization chamber and click it into position.
2. SET-UP 2.1. INSTALLATION The sterilizer has been calibrated and tested in the factory. It does not require calibration during installation. Working temperature range: Storage temperature range : 10°C to 40°C / Humidity : 0 to 90%. -20°C to 60°C / Humidity : 0 to 90% (Water tanks empty). Install the sterilizer as outlined below: ព ព Install the sterilizer on a flat and level surface. ព ព ព ព Leave a gap of 5 cm at the back and 2 cm on each side of the sterilizer to ensure adequate ventilation.
2.2. ELECTRICITY SUPPLY The electrical installation must comply with the current standards in the country. ព The electricity supply must be single phase 230 volts ±10%, 50/60Hz, 10A. ព ព Installation category / Mains overload category = II An earth connection is essential. The sterilizer must be connected to an electrically earthed plug. Use only the mains cable delivered with the sterilizer. The maximum absorbed power of the sterilizer is 2100 W (9,2A).
2.3. PRINTER CONNECTION (OPTIONAL) Attention ! We recommend to use the following printer: - Custom DP40H. It has been tested and is perfectly compatible with the sterilizer and its software. The use of another printer is undertaken with the full responsability of the user, clearing the manufacturer, W&H l STERILIZATION of responsability for warranty and any other claim. Connect the printer cable to the 25 pin parallel port socket at the back of the sterilizer.
3. DESCRIPTION 3.1. FRONT VIEW OF THE STERILIZER Touch screen Door Service door Main switch / circuit breaker * Switch ON/OFF of the sterilizer. Use this switch to interrupt a cycle only in the case of a noted defect. 9 pin serial port For technical department only. * Replaces the fuses.
3.2.
4. USE 4.1. MAIN MENU Activate the mains switch, the selection screen appears. Manual stand-by Cycle selection (§ 4.6.2.) Access to sub menus (§ 4.5.) If the sterilizer is not used for a certain period of time, it will automatically go into stand-by mode. Stand-by mode time is programmable (§ 4.5.6.). When the sterilizer is switched ON, the chamber is automatically heated to 110°C. Pre-heating starts from room temperature and takes approximately 10 minutes.
4.2. DESCRIPTION OF THE WATER TANK The sterilizer is equipped with 2 independent water tanks of equal volume - 3.5 litres (MB17) or 4,5 litres (MB22). The left tank also called the "main tank" contains the distilled or demineralized water required for each cycle. It is fitted with 2 level sensors, minimum (0.5 l) and maximum (3.5 l on MB17 or 4.5 l on MB22). The right tank called the "used water tank" contains the used water collected at the end of each cycles. It is fitted with a maximum level sensor (3.
4.3. FILLING OF THE MAIN WATER TANK Attention ! Use only high quality distilled or demineralized water (see Annex 7). Remove the main water tank cap located on the top of the sterilizer … …Fill the tank with approx. 3 litres on MB17 (or 4 litres on MB22) of water... …Once the tank is almost full, an audible tone will be heard. When you hear the tone proceed carefully. You must stop filling as soon as the water level reaches the lower edge of the opening to the water tank.
4.4. DRAINING OF THE USED WATER TANK When the used water tank is full, it is impossible to run another cycle. The following message appears: DRAIN THE U S E D W AT E R TA N K ♦ Open the service door. ♦ Insert the drain tube into the quick coupling drain connection of the used water tank (right) as shown in the diagram. ♦ Allow the entire contents of the tank to empty and discard the used water. NEVER RE-USE THE USED WATER ! Disconnect the drain tube by pressing the push button on the drain connection.
4.5. PROGRAMMING Press the "M" key on the selection screen… …The program menu is displayed… To exit the program menu Cursor UP Consult: § 4.5.1. § 4.5.2. § 4.5.3. § 4.5.4. § 4.5.5. § 4.5.6. § 4.5.7. § 4.5.8. ➔ ➔ ➔ ➔ ➔ ➔ ➔ ➔ LANGUAGE USER NAME D AT E / C L O C K PR I N T E R TOUCH SCREEN S TA N D - B Y MAINTENANCE SERVICE Cursor DOWN Access to sub-menu … Place the cursor ">" in front of the desired sub-menu using the "UP" and "DOWN" keys. Confirm the selection by pressing the sub-menu access key.
4.5.1. SELECTING THE LANGUAGE To exit the sub-menu Cursor UP Cursor DOWN Selection confirmation 4.5.2.
4.5.3. PROGRAMMING THE DATE AND TIME It is essential to adjust the date and time especially if the sterilizer is connected to a printer. These parameters are systematically printed at the beginning and at the end of the cycle report. Place the selection cursors under the data that is to be adjusted. Increase or decrease its value, move the cursors under the next value and repeat operation. Confirm the adjustment by pressing the "Ok" key.
4.5.5. PROGRAMMING THE BRIGHTNESS OF THE TOUCH SCREEN Darker Lighter Confirmation, exit from the sub-menu 4.5.6.
4.5.7. MAINTENANCE PROGRAM This screen shows the number of cycles remaining before replacement of the bacteriological filter (400), the door seal (1000) as well as when general servicing (4000) is required. The three counters are decreased in value after each cycle. When one of the counters reaches 0 a corresponding message appears at the bottom of the selection screen.
4.6. CYCLE SELECTION 4.6.1. CYCLE TABLE STERILIZATION CYCLES B CYCLE B CYCLE B CYCLE B-STANDARD B-PRION B-STANDARD 134 134 121 TYPE OF CYCLE TEST CYCLES B&D/ HELIX TEST VACUUM TEST Temperature 135.5°C 135.5°C 122.5°C 135.5°C -- Pressure 2.16 bar 2.16 bar 1.16 bar 2.16 bar -0.
4.6.2. SELECTION – START OF THE CYCLE Exit, if necessary, from the stand-by mode… …Enter cycle select menu… Exit and return to selection screen Cursor UP Cursor DOWN Confirmation of the selection Position the cursor in front of the required cycle. Confirm your selection by pressing the "OK" key. Start the selected cycle.
4.6.3. CYCLE PROCEDURE The following information is displayed during the cycle: Date Time Access to technical data ➫ § 4.8 Selected cycle N° of the cycle Temperature Pressure Manual stop ➫ § 4.7 Current phase Total duration You can access the technical parameters at any time by pressing the "Info" icon (see § 4.8.). If needed, the cycle can be interrupted by pressing the "STOP" icon for 2 seconds. An audible tone will confirm your request.
4.7. MANUAL STOP If needed, the cycle can be interrupted at any moment by pressing the "STOP" key for 2 seconds. An audible tone will confirm the request… 2” MANUAL STOP PLEASE WAIT LOAD NOT STERILE …This is followed by a phase of approximately 2 minutes, required to reinitialise the system and return the chamber to atmospheric pressure. The door can be opened when the "Exit" key appears on the display at the end of this phase.
4.8. CYCLE DATA INFORMATION You can access the technical data at any time during the cycle by pressing the "Info" icon. ..The following data will be displayed… Date Time Chamber pressure T° calculated/Pressure T° of the steam T° chamber heater T° steam generator Phase in progress Duration of the phase Exit and return to the current cycle screen.
4.9. CYCLE DATA SUMMARY (end of cycle) At the end of the cycle, before opening the door, the "Info" icon gives access to the technical data summary of the completed cycle. The first screen lists the pressure and duration of each phase until the process... ( PV- vacuum pulse / PP- pressure pulse ) Exit and return to "cycle end" screen …The second screen indicates the temperature and pressure relating to the sterilization phase: Measured pressures : begin. / end / min. / max.
5. MESSAGES A certain number of messages can appear at the beginning or at the end of the cycle. This is merely information and not an alarm. The user can continue to operate the sterilizer with complete confidence. During a cycle, the micro-processor continuously analyses all the parameters. The cycle would be interrupted immediately and an alarm displayed, if there was a concern with the sterilization quality (see § 6).
6. ALARMS The micro-processor continuously analyses all the cycle parameters. If there is any doubt regarding sterilization efficiency, the cycle is immediately interrupted and an alarm displayed. This is followed by a phase of approximately 2 minutes required to reinitialise the sterilization system and to return the chamber to atmospheric pressure.
6.1. DESCRIPTION OF THE ALARMS N° Description Action Mains Mains failure or significant fall in voltage occurred A01 during the cycle. The load cannot be considered sterile. The cycle must be repeated. Sterilization chamber The time spent to reach the sterilization plateau is Clean the door seal, repeat the cycle. If the problem persists ℡ service. The temperature of the chamber heating element Repeat the cycle. If the problem persists ℡ service.
DESCRIPTION OF THE ALARMS (continue) N° Description Action Vacuum pump During a vacuum phase, the maximum achieved Clean and check the door seal (§ 7.2.), repeat the cycle. If the problem persists ℡ service. During a vacuum phase, the maximum achieved Clean and check the door seal (§ 7.2.), repeat the cycle. If the problem persists ℡ service. A31 vacuum is not lower than – 0.20 bar. A32 vacuum is not lower than – 0.50 bar.
7. USER MAINTENANCE A distinction must be made between two levels of maintenance, that performed regularly by the user and preventive maintenance carried out by an approved technician (§ 8). Remove the mains cable before examining the sterilizer. 7.1. MAINTENANCE PROGRAM Frequency / Weekly N° of cycles 50 Spare number Description Cleaning the door seal. - § 7.2. Cleaning the chamber, the trays and the rack. - § 7.3. Cleaning the external surfaces. - § 7.4. W322400X § 7.5. - § 7.6.
7.2. CLEANING THE DOOR SEAL Clean the door seal and the porthole with a lint free cloth saturated with alcohol. The porthole can also be cleaned with a non-abrasive detergent. 7.3. CLEANING THE CHAMBER, TRAYS AND TRAY HOLDER Remove the trays from the chamber. Disconnect and remove the rack. Clean the chamber with a damp sponge moistened with a detergent or scouring agent if necessary. Rinse with a damp sponge to remove all traces of the cleaning agent.
7.6. CLEANING THE WATER TANKS Completely drain both water tanks (main and used water tank). Open the service door. Insert the drain tube into the quick coupling drain connection of the used water tank (right). Allow the entire contents of the tank to empty and discard the used water. Disconnect the drainage hose by pressing the push-button on the drain connection. + Insert the drain tube into the quick coupling drain connection of the main water tank (left).
7.7. REPLACING THE DOOR SEAL Fully open the door of the sterilizer. Remove the door seal by hand. Carefully clean the seal seat with a cotton bud moistened with alcohol. Moisten the new seal. Insert the seal in the sequence illustrated in the following diagrams: Insert the seal starting as follows: Up Down Left and right.
8. SERVICING CONDUCTED BY THE APPROVED TECHNICIAN Service is essential to continued effective sterilization. We recommend servicing by an approved technician every 3 years or 4000 cycles. Check list: Replacement of the 5 Solenoid valves. Replacement of the vacuum pump membrane kit. Replacement of the water filter. Replacement of the steam generator heating element. Cleaning the sterilization chamber. Cleaning the sterilization chamber filter. Cleaning the steam generator filter (EV5).
9. BREAK-DOWN GUIDE The list below of problems is limited because most defects and incidents are covered in messages (§5) and alarms (§6). PROBLEMS POTENTIAL CAUSES The main switch or network circuit breaker is open (OFF). No voltage at the socket. The mains cable is not properly connected. Activate the main switch or network circuit breaker (ON). Check the electrical circuit. Plug in the cable. Water leaking at the front of the sterilizer. Leaks via the door seal.
Annex 1 TECHNICAL CHARACTERISTICS Electricity supply Single phase 230 VAC ±10% – 50/60Hz – 10A Sterilizer: Name plate situated on the back side: Working temperature / Humidity Storage temperature / Humidity Min. atmospheric pressure Nominal voltage : Max. absorbed power : Max. current : Dimensions overall : Max. space required : Clutter of the door movement : Weight empty : Max. mass in working condition fully loaded : Max. heat output : Max. noise level : 10°- 40°C / 0-90%.
Annex 2. PREPARATION OF THE LOAD 1. Cleaning of the instrument The instruments to be sterilized must be clean and free from all types of residue such as fragments, dentine and blood, etc. These substances can damage the objects placed in the trays and even the sterilizer itself. ♦ Clean the instruments immediately after use. Follow the manufacturer’s instructions when using an ultrasonic cleaner. ♦ Remove all traces of disinfectant from the product as this may cause corrosion on heating.
Annex 3 1. MAINTENANCE OF DYNAMIC INSTRUMENTATION External disinfecting This procedure prevents the risk of infection during cleaning and maintenance. ♦ Wear gloves. ♦ Dampen the instrument with a non-corrosive disinfectant (pH from 2.5 to 9) or with 70-80% ethyl alcohol. ♦ Comply with the disinfection reaction times recommended by the manufacturer. Immerse or vaporise the instruments. Do not allow the disinfectant to come into contact with the instrument, poor rinsing, etc.
Annex 4: BOWIE & DICK TEST The Bowie & Dick Test, also called the Brown Test, is representative of the small porous type load. It comprises several sheets of paper and foam wrapped in a small packet in the middle of which there is a chemical heat-sensitive indicator strip (physic-chemical test). This test is used to validate the equipment performance in terms of textile load sterilization, i.e.: Pre-vacuum efficiency and thus steam penetration.
Annex 5 HELIX TEST The Helix Test is the most complex representation of a hollow instrument load ( type A ). Characteristics: Length: 150 cm Strip test Internal diameter: 2 mm Material : PTFE This test is used to validate the equipment performance in terms of hollow instruments sterilization, namely: Pre-vacuum efficiency, rapid and uniform steam penetration. Temperature and pressure parameters of saturated steam during the holding time. Pressure (bar) 2.
Annex 6 VACUUM TEST This test is used to validate the performance of the sterilizer in terms of leakage: The efficiency of the vacuum pump. The tightness of the pneumatic circuit. Pressure Duration T1 T2 T3 P1 P2 P3 -0.65 -0.85 The profile of the cycle, specific for this test includes: A vacuum phase up to P1 = - 0.85 bar. A stabilisation period of 5' => T2. Reading of P2. A testing period of 16' => T3. Reading of P3.
Annex 7 WATER QUALITY The table below lists the quality of the water to be used for steam sterilization as taken from the new European standard (EN 13060, Annex C) Table C.
Annex 8 ACCESSORIES DESCRIPTION SPARE NUMBER Printer: Custom DP40H/cable A70010XX Anodised perforated aluminium trays 18,5mm x 28,5mm T523200X (MB17) T523202X (MB22) Reversible rack F523002X (MB17) F523006X (MB17) Cassette holder F523000X Tray holder F523001X Drain tubing with quick coupling S230900X Mains cable / Funnel F540902X Bacteriological filter W322400X Door seal F460503X 43 User manual
Manufacturer: W&H Sterilization S.r.l Italy, I-24060 Brusaporto (BG) Via Bolgara, 2 t +39/035/66 63 000 f +39/035/50 96 988 wh.
