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OPERATION
&
MAINTENANCE
MANUAL
Electronic Tabletop Autoclaves
Models EZ9, EZ10, EZ10K
Cat. No. MAN205-0263001EN Rev. K
Tuttnauer Ltd., Har Tuv B Industrial zone P.O.Box 170, 9910101, Beit Shemesh IsraelTel: 972 2 9904611,
Fax: 972 2 9904730
Tuttnauer U.S.A. Co Ltd., Ltd. 25 Power Drive Hauppauge, NY, 11788, USA. Tel (631) 737 4850, (800) 624 5836,
Fax: (631) 737 0720
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Summary of Contents for Tuttnauer EZ10
- Page 1 Tuttnauer Ltd., Har Tuv B Industrial zone P.O.Box 170, 9910101, Beit Shemesh IsraelTel: 972 2 9904611, Fax: 972 2 9904730 Tuttnauer U.S.A. Co Ltd., Ltd. 25 Power Drive Hauppauge, NY, 11788, USA. Tel (631) 737 4850, (800) 624 5836, Fax: (631) 737 0720...
- Page 2 Web site: http//www.tuttnauerUSA.com...
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Page 3: Table Of Contents
TABLE OF CONTENTS Paragraph Page No. GENERAL ............................4 Manufacturer and US Official Correspondence Information ........4 Intended Use ........................4 Intended Users ........................4 Incoming Inspection ......................4 Warranty ........................... 4 Warranty Statement ......................5 SAFETY INSTRUCTIONS ......................6 TECHNICAL DATA ........................ - Page 4 MAINTENANCE INSTRUCTIONS ................... 40 10.1 Preventive and Scheduled Maintenance ................ 40 10.2 Replacing the Air Filter ....................42 10.3 Draining the Reservoir ....................43 10.4 Cleaning the Air Jet ....................... 44 10.5 Replacing the Door Gasket .................... 45 10.6 Checking the Safety Valve....................46 10.7 Replacing the Fuse ......................
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Page 5: General
Tuttnauer. All Tuttnauer products are carefully inspected prior to shipment and all reasonable precautions are taken in preparing them for shipment to assure safe arrival at their destination. -
Page 6: Warranty Statement
No product will be received or accepted for repair without prior return authorization from Tuttnauer. All transportation charges to and from Tuttnauer must be paid by the owner of the autoclave. During the first 90 days after purchase of an autoclave, Tuttnauer will pay shipping costs on an individually evaluated basis and ONLY with pre-approval. -
Page 7: Safety Instructions
SAFETY INSTRUCTIONS The autoclave has unique characteristics. Please read and understand the operation instructions before first operation of the autoclave. This manual includes instructions and guidance provided by the manufacturer: how to operate the autoclave, the door safety mechanism, and the dangers involved in circumventing safety means, how to ensure that the door is closed, and how to select a correct sterilization program. - Page 8 14. Make sure there are no leaks, breaks, blockages, whistles, or strange noises. 15. Perform maintenance operations as instructed. The owner of the autoclave is responsible to perform the maintenance operations. 16. Notify the person in charge immediately of any deviation from the proper function of the device.
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Page 9: Technical Data
2 hours. This feature is standard on model EZ10K and optional on EZ9 and EZ10 models. Environmental Emission Information 1. The peak sound level generated by the autoclave is less than 70 dBA... -
Page 10: Operating Conditions
2. The total heat per hour transmitted by the autoclave is < 100 Wh for all models. Operating Conditions This device is to be used for indoor use. This autoclave is intended for NORMAL environment conditions as follows: Altitude up to 2000m. ... -
Page 11: Symbol Description
Symbol Description Manufacturer Year of Manufacturing Medical Device Model Number Serial Number Consult the Operation and Maintenance Manual (User Manual) before Keep away from sunlight and protect from heat. For Indoor Use Only Keep dry Disposal according to electronic scrap ordinance This side up (during transport and shipment) Fragile (during transport and shipment) A warning or precaution as detailed in the Operation and Maintenance... -
Page 12: Electrical Data
11.7 Watts (W) 1400 1400 2200 Frequency 50 / 60 Hz Protection against electrical shock IEC 61010-1 AUTOCLAVE TYPE DESCRIPTION EZ9, EZ10 EZ10K 120V 230V 230V Circuit breaker (A) Air pump fuse (A) 1.25 1.25 Water pump fuse (A) 1.25 1.25... -
Page 13: Maximum Solid Load Sizes
Maximum Solid Load Sizes (Textile load = 1/3 of solid load) Loads Models 1730 2340 (EZ9) 2540 (EZ10) 3140 11.0 3850 13.6 3870 14.0 3.10 Specifications Overall Dimensions... -
Page 14: Technical Specifications
Model EZ10, EZ10K Dimensions 20.0 20.0 Overall Dimensions 14.4 14.4 21.5 21.5 Maximum 35.8 35.8 Dimensions (door 24.8 25.8 open) 11.8 11.8 16.6 16.6 Distance Between Supporting Legs 15.8 15.8 Reservoir Volume 3 lit. 0.8 gal. 3 lit. 0.8 gal. -
Page 15: Directives And Standards
3.12 Directives and Standards Every autoclave meets the provisions of the following Directives and is in compliance with the following Standards: Medical Device Directive 93/42/EEC as amended by 2007/47/EC Medical Device Single Audit Program – (MDSAP) ISO 9001: Quality Management System Quality Management System –... -
Page 16: Water Quality
3.13 Water Quality The distilled or mineral-free water supply shall be according to the table below: Suggested maximum limits of contaminants in water for steam sterilization per EN13060 Substance Feed Water Condensate ≤ 10 mg/l ≤ 1.0 mg/l Evaporate residue ≤... - Page 17 FRONT VIEW Description Description Reservoir water drain valve Air relief valve Ring for drain valve Panel base Door closing device Front panel key board Door switch (under door) Printer Autoclave cover Main switch Water reservoir cover RS232 port cover Water reservoir – assembly Completion to panel Safety valve...
- Page 18 REAR VIEW...
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Page 19: Keyboard (Keys And Display)
KEYBOARD (Keys and Display) FRONT PANEL KEYBOARD Note: See section 4.2 for a description of the Keyboard buttons... -
Page 20: Indicator Light Description
Indicator Light Description Programs Shows the selected program Indicators START Shows the system is running a program. HEAT The system is currently in the Heating stage. The system is currently in the Sterilization stage. The system is in the Exhaust stage. The system is in the Dry stage. -
Page 21: Description And Functions Of The Control Panel Keyboard
Description and Functions of the Control Panel Keyboard 4.2.1 Program keys (1) Unwrapped Instruments (2) Wrapped Instruments (3) Glassware (slow exhaust, no drying) Pressing one of the above program keys determines the chosen program. The program parameters are displayed, and the program indicator lights. - Page 22 (9) DN Pressing these keys in combination with TEMP. (5), STE TIME (6), DRY Time (7) and CLOCK (9) lowers these values. (10) CLOCK Pressing the CLOCK programming key displays the date, with the cursor under the day. Pressing the UP or DN keys changes the date.
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Page 23: Description Of The Display Panel
(13) STOP This key issues the only command accepted by the system during the running of a program. Pressing this key for over 1 second causes the program to immediately cease running and enters the EXHAUST stage, at the end of which the “MAN. STOP”... - Page 24 Low Heat Message is displayed, and sterilization does not start if the autoclave has not reached sterilization temperature after heating for 50 minutes while in the Wrapped or Unwrapped programs (80 minutes in the Glassware program). Possible causes: A clogged Air Jet (see cleaning the Air Jet sec 9.4). ...
- Page 25 Message is displayed, if during a normal heat up stage the system determines that there is insufficient water in the chamber to complete the cycle. This determination is made by the combined input of two sensors, the Water Electrode and the Safety Thermostat. Also, if a power failure occurs during the heat or sterilization stage after the power returns, the system will check the Water Electrode to see if there is sufficient water in the chamber to resume the cycle.
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Page 26: Sterilization Programs
STERILIZATION PROGRAMS The autoclave offers 3 sterilization programs, at temperatures of up to 274F (134C), with or without a drying stage and 1 accessory (dry only) program. A. Three sterilization programs: 1. Unwrapped instruments. 2. Wrapped instruments and porous loads. 3. -
Page 27: Program 2. Wrapped Instruments And Porous Loads
PROGRAM 2. Wrapped Instruments and Porous Loads For wrapped instruments and materials, when the manufacturer recommends autoclaving at temperatures between 250F and 274F (121C and 134C) with a drying stage. Nominal parameters default settings Sterilization temperature: 273F (134C). Sterilization time: 7 minutes. ... -
Page 28: Program 3. Glassware
PROGRAM 3. Glassware For all glassware intended for sterilization. Nominal parameters default settings Sterilization temperature: 250F (121C). Sterilization time: 30 minutes. Slow exhaust: 15 to 20 minutes. Drying time: Drying time is not available in this program. Operations sequence: ... -
Page 29: Printer (Optional)
PRINTER (Optional) The printer is an optional device. If the autoclave is not equipped with a printer, paragraph 6 is not applicable. Printer Operation The autoclave is equipped with a character printer that prints a detailed history of each cycle performed by the instrument (for the record or for subsequent consideration). - Page 30 PRINTER OUTPUT DESCRIPTION Autoclave No: 01 Number of the autoclave with respect to other units in the same location. Load number: 0005 Load number. Useful to determine when to clean the chamber. (Upon reaching 255, this number is reset to 0). Operator:___________ To be filled in manually by operator.
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Page 31: Printer Handling
Printer Handling The printer is driven and controlled automatically by the control unit, while the autoclave performs a sterilization program. Figure 1 Figure 2 To set the paper roll in the printer, perform the following steps: 6.2.1 Gently push the clips for removing the front panel, remove the panel and pull out the printer gently. -
Page 32: Installation Instructions
7.1.1 Setup Your new Tuttnauer Autoclave was set at the factory and requires a minimal of setup. Make sure the counter is level and sturdy. Make sure all the feet are on the autoclave and none have been lost. -
Page 33: Water Filling
Automatic Water Filling The proper amount of water for automatic filling in your new Tuttnauer autoclave has been preset at the factory. However, if in routine operation there is inadequate water in the chamber, the operator can adjust the level with the automatic built-in system by doing the following: 1. -
Page 34: Lifting And Carrying
Warning: If it becomes necessary to RESET the software program, it will be essential to repeat all steps listed above. This will ensure that the correct amount of water enters the chamber for operation. VERY IMPORTANT – Due to the fact that the water lines are empty when the unit is shipped, air may become trapped in the lines. -
Page 35: Filling The Water Reservoir
Filling the Water Reservoir Remove the water reservoir cover. Pour distilled water into the reservoir through the opening on top of the autoclave until it reaches the base of the safety valve holder, approximately 0.7 gallons (3 liters). Use water-having characteristics as per table in sec 3.13 Caution: Under no circumstance should water be filled above the safety valve holder. -
Page 36: Preparation Before Sterilization
6. Do not place materials to be sterilized against the chamber’s wall. Place the material only on the tray or rack. When using a paper / plastic bag, Tuttnauer recommends the use of a Tuttnauer Pouch Rack. If a pouch rack is not available, then Tuttnauer recommends placing the paper side down on the tray. - Page 37 18. Do not stack pouches. It is recommended that a pouch rack such as the Tuttnauer POUCH RACK be used to insure proper steam penetration and adequate drying. Surfaces that are hidden, because the items are being stacked, will not be exposed to the steam, and will not be sterilized.
- Page 38 21. If spotting is detected on the instruments, the first step would be to use an ordinary eraser to remove the spot. If there is no pitting under the spot then the spot was only dirt. Dirt spots on an instrument may be an indication that the autoclave needs to be cleaned or that the instruments were not adequately cleaned or dried.
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Page 39: Operating Instructions
OPERATING INSTRUCTIONS It is important to clean the hole of the air jet, as described in sec. 10.4 before starting operation of the autoclave for the first time. 1. Remove water reservoir cover. Pour distilled water into the reservoir, through the opening on top of the autoclave, until it reaches the base of the safety valve holder, approximately 0.7 gallons (3 liters). - Page 40 (0.2m), and pushes that air through the heated chamber and out the air outlet valve to remove moisture and facilitate the drying operation. Drying is performed with the door closed. 9. At the end of the cycle a buzzer rings for approximately 5 seconds, the START light switches OFF.
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Page 41: Maintenance Instructions
Should the need arise, technical assistance or a serve technician can be requested by either calling your dealer or Tuttnauer USA. Note: Where daily maintenance is indicated this would only pertain to days the equipment is in use. - Page 42 5. Put a few drops of oil on the 2 door pins and door tightening bolt. 6. Clean the outer parts of the autoclave with a soft cloth. 9.1.3 Periodically Caution! Make sure the autoclave is not hot before cleaning it. 1.
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Page 43: Replacing The Air Filter
10.2 Replacing the Air Filter To facilitate drying the instruments with the door of the chamber closed, the autoclave is equipped with an air compressor and HEPA filter (0.2µm). During the drying stage the compressor draws air through the HEPA filter and forces the circulation of that air through the heated chamber to remove moisture from the wrapped instruments. -
Page 44: Draining The Reservoir
10.3 Draining the Reservoir Caution Before starting, ensure that the electric cord is disconnected and there is no pressure in the autoclave. The drain valve is located on the front left side of the autoclave after the door is opened. The function of the drain valve is to drain the water reservoir. -
Page 45: Cleaning The Air Jet
10.4 Cleaning the Air Jet (Located in the water reservoir.) A dirty air jet is the number one cause of failed spore tests The elimination of air from the sterilization chamber during heat up is critical to the proper operation of the autoclave. Failure of the air removal system will be responsible for incomplete sterilization, indicator strips that do not turn, failed spore tests and aborted sterilization cycles. -
Page 46: Replacing The Door Gasket
10.5 Replacing the Door Gasket Pull off the gasket from the door groove. Install the new gasket as described in drawings 1, 2 and 3 above. Caution! This gasket is designed with a trapezoidal cross section. The gasket should be placed with the widest side towards the door. -
Page 47: Checking The Safety Valve
10.6 Checking the Safety Valve (Located in the water reservoir) To prevent the safety valve from becoming blocked, it is necessary to allow the steam pressure to escape through the valve. This procedure should be done every month as follows: 1. -
Page 48: Replacing The Fuse
10.7 Replacing the Fuse Caution Make sure that the electrical power cord is disconnected! Use a screwdriver to unlock the fuse holder cover by turning it counterclockwise ¼ turn and pull it out. Insert a new fuse into the holder and turn the cover clockwise until locked. -
Page 49: Cleaning Water Outlet Strainer
10.8 Cleaning Water Outlet Strainer Caution! Before proceeding, make sure that the electric cord is disconnected and there is no pressure or water in the chamber. Warnings The strainer’s cover is HOT Do not touch the strainer’s cap, mounted on the exhaust line, during and shortly after operation. - Page 50 Strainer Strainer Gasket element Housing...
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Page 51: Cleaning Tabletop Autoclaves With Chamber Brite
Cleaning Tabletop Autoclaves with Chamber Brite ™ 10.9 CHAMBER BRITE is a cleaning and descaling agent designed specifically for cleaning and removal of water deposit oxides and other sediments that are found in steam sterilizers. The material is a combination of acidic salts and additional cleaning materials. Chamber Brite is not for use on the Elara11 or any other pre/post vac autoclave. -
Page 52: Water Sensor Cleaning
10.10 Water Sensor Cleaning It is required that the water sensor be cleaned at least once per week. Cleaning the sensor will ensure that the water level in the chamber is properly reported to the microprocessor all during the cycle. The water sensor is located in the rear of the chamber.
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