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Summary of Contents for Tuttnauer ELARA
- Page 1 OPERATION & MAINTENANCE MANUAL Pre-vacuum Table–top Autoclave Model ELARA Cat. No. MAN205-0342001EN Rev D Tuttnauer Europe b.v., Paardeweide 36, 4824 EH, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510, Fax: +31/76-5423540...
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Page 3: Table Of Contents
T A B L E O F C O N T E N T 1. GENERAL........................ 4 1.1..................4 NCOMING NSPECTION 1.2...................... 4 ARRANTY 1.3................. 4 ARRANTY TATEMENT 2. SAFETY INSTRUCTIONS ..................6 3. GENERAL INFORMATION ................. 7 3.1. - Page 4 10. OPERATING INSTRUCTIONS ................44 10.1. T ..............44 URNING ON THE AUTOCLAVE 10.2 ..................44 PENING THE DOOR 10.3 ....................... 44 OADING 10.4. O ....................45 PERATIONS 10.5. U ....................45 NLOADING 10.6. S ................45 TOPPING THE PROCESS 10.7.
- Page 5 T A B L E O F I L L U S T R A T I O N S FRONT VIEW ......................14 REAR VIEW ......................15 TRAY HANDLE ......................55 POUCH RACK ......................55 TRAY ..........................55 TRAY HOLDER......................55 Page 3 of 56...
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Page 6: General
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 7 No products will be accepted for repair without proper authorization from us. All transportation charges must be paid both ways by the owner. This warranty will be void if the unit is not purchased from an authorized full service Tuttnauer dealer. Page 5 of 56...
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Page 8: 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 guidance provided by the manufacturer: how to operate the autoclave, the door safety mechanism, and the hazards involved in circumventing safety means and how to select an adequate sterilization program. -
Page 9: General Information
GENERAL INFORMATION 3.1. Intended Use This table-top autoclave is designed for sterilization of medical and surgical goods such as unwrapped and wrapped, solid, hollow, porous products and goods that are defined as hollow A in ophthalmic, dental and medical clinics, first aid rooms, small laboratories etc. 3.2. -
Page 10: Operating Conditions
3.3. Operating Conditions This device is for indoor use only! The sterilizer should be loaded only with autoclavable material! Minimum room ventilation shall be10 cycles per hour The environment shall not exceed an ambient temperature range of 5ºC-40ºC and a relative humidity of 85% respectively. The operation altitude shall not be over 2000 meters (ambient pressure shall not be lower than 80 kPa (11.6 psi)). -
Page 11: Specifications
3.4. Specifications Overall Dimensions Front View Top View Property Value Max. Allowable Working Pressure (MAWP) 2.8 bar (40 psi) Diameter 280 mm (11”) Chamber Depth 504 mm (19.8”) Chamber volume 28.5 lit. (7.5 gal) Width (A) 530 mm (20.8”) Height (B) 444 mm (17.4”) External dimensions Length (C) -
Page 12: Utilities
Property Value Weight 66 kg (145.5 lb) 1.71 N/m2 Weight per support area (max. load) (0.036 lb/ft2) Shipping weight 71 kg (156 lb) Width 63 cm (24.8”) Height 71 cm (28.0”) Shipping dimensions Length 80 cm (35.8”) Volume 0.36 m3 (14.5 ft3) Max. -
Page 13: Construction
3.8. Construction The main parts of the autoclave are made of materials as indicated below: • Chamber is built of stainless steel 316 L. • Door is made of stainless steel 316. • Trays are made of stainless steel 316. •... -
Page 14: Water Quality
3.10. Water Quality Physical characteristics and contaminants levels The distilled or mineral – free water supplied to the autoclave should have the physical characteristics and maximum acceptable level of contaminants indicated in the table below: Physical Characteristics and Maximum acceptable contaminants levels in water or steam, for steam generator and sterlizers (According to EN 285:2006). -
Page 15: Directives And Standards
3.11. Directives and Standards Every autoclave meets the provisions of the following Directives and is in compliance with the following Standards: 3.11.1. Technical Standards EN 13060:2004 – Small Steam Sterilizers. ASME Code, section VIII division 1 for pressure vessels. EN 61326, Electrical equipment for measurement, control and laboratory use-EMC requirements UL/IEL/EN 61010-1... -
Page 16: Front View
FRONT VIEW No. Description No. Description Water reservoir funnel Operating key board Autoclave cover Printer cover Water level side gauge Printer (option) Mineral-free water reservoir cover Legs Chamber and steam generator safety Waste water reservoir drain valve valves Mineral-free water reservoir drain Waste water reservoir cover valve Display... -
Page 17: Rear View
REAR VIEW No. Description Mineral-free water reservoir cover Waste water reservoir cover Ventilation grills Air filter service cover Opening for calibration Main power electric cable socket Page 15 of 56... -
Page 18: Keyboard
KEYBOARD Description Display Keypad Printer Page 16 of 56... -
Page 19: Description And Functions Of The Front Panel Keyboard
4.1. Description and Functions of the Front Panel Keyboard The front panel is composed of 3 sections: 1. Display screen. 2. Keypad. 3. Printer 4.1.1. Display screen The display is a graphical screen used to display the current status of the autoclave while using Operational Messages and Error Messages. - Page 20 4.1.2. Keypad The keypad consists of 3 keys as described below: UP key This key has the following functions: • In the main screen: o This key enables the operator to brows through the cycles. • In the directories available: o When the cursor is blinking on a number, the UP ▲...
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Page 21: Displayed Error And Operational Messages
4.2. Displayed Error and Operational Messages Error Error Message Description Corrective Action Number Name Err:001 Pt1 out This message and symbol are Call the technician. displayed when the Chamber Temperature sensor Pt1 is disconnected or out of range. Err:002 This message displayed when Check that the Temperature the temperature drops for... - Page 22 Error Error Message Description Corrective Action Number Name Err:013 Air Valve Message is displayed when the Replace air filter. Error system can't reach the atmosphere pressure in the chamber by opening Air Valve for 3 minutes. Err:014 The message displayed if the Verify that the door Vacuum system can't reach the required...
- Page 23 Error Error Message Description Corrective Action Number Name The autoclave's door is open. Close the door to perform a new cycle. The generator is not ready. Wait for the generator to create steam. Page 21 of 56...
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Page 24: Sterilization Programs
STERILIZATION PROGRAMS The autoclave offers 6 sterilization programs and 2 test programs as follows: Sterilization Programs: Program 1 Flash 134 Program 2 P 134 Program 3 Wdry 134 Program 4 No Dry 121 Program 5 Wdry 121 Program 6 Delicate 121 Tests programs: Test 1 B&D Test... -
Page 25: Program 1: Flash 134
5.1. Program 1: Flash 134 Program 1 is recommended for sterilizing unwrapped instruments, at temperatures of 134ºC/273ºF with 1 minute drying stage, which its manufacturer declares their compliance to be sterilized in the following conditions: The solid load shall not exceed 8kg (17.6 lb). Nominal Parameters •... -
Page 26: Program 2: P 134
5.2. Program 2: P 134 Program 2 is recommended for sterilizing double wrapped instruments, porous loads and Hollow A (e.g. dental hand pieces, suction pipes) loads at temperatures of 134ºC/273ºF with 20 minutes drying stage, which its manufacturer declares their compliance to be sterilized in the following conditions: The solid load shall not exceed 8kg (17.6 lb). -
Page 27: Program 3: Wdry 134
5.3. Program 3: WDry 134 Program 3 is recommended for sterilizing double wrapped instruments, porous loads and Hollow A (e.g. dental hand pieces, suction pipes) loads at temperatures of 134ºC / 273ºF with 20 minutes drying stage, which its manufacturer declares their compliance to be sterilized in the following conditions: The solid load shall not exceed 8kg (17.6 lb). -
Page 28: Program 4: Nodry 121
5.4. Program 4: NoDry 121 Program 4 is recommended for sterilizing unwrapped instruments at a temperature of 121ºC / 250ºF without drying stage, which its manufacturer declares their compliance to be sterilized in the following conditions: The solid load shall not exceed 8kg (17.6 lb). Nominal Parameters •... -
Page 29: Program 5: Wdry 121
5.5. Program 5: Wdry 121 Program 5 is recommended for sterilizing double wrapped instruments, porous loads and Hollow A (e.g. dental hand pieces, suction pipes) loads at temperatures of 121ºC/250ºF with 20 minutes drying stage, which its manufacturer declares their compliance to be sterilized in the following conditions: The solid load shall not exceed 8kg (17.6 lb). -
Page 30: Program 6: Delicate 121
Program 6: Delicate 121 Program 6 is recommended for sterilizing delicate instruments at temperatures of 121ºC/250ºF with slow exhaust, which its manufacturer declares their compliance to be sterilized in the following conditions: The solid load shall not exceed 8kg (17.6 lb). Nominal Parameters •... -
Page 31: Est 1: B&D Test
5.7. Test 1: B&D Test Test 1 is the Bowie & Dick test program, with fixed sterilization parameters 134ºC and 3.5mins, which cannot be modified by the operator or the technician. Nominal parameters • Sterilization temperature: 134ºC • Sterilization time: 3.5 minutes. •... -
Page 32: Test 2: Vactest
5.8. Test 2: VacTest Note: Before performing this test, verify that the autoclave is cold and that the autoclave is dry (not humid and no water drops). Vacuum is produced in the chamber down to P =17 kPa. At this stage all the valves are close. -
Page 33: Monitoring And Changing Parameters And Other Data
MONITORING AND CHANGING PARAMETERS AND OTHER DATA In order to set the autoclave's clock, check the main sterilization parameters (sterilization time, and dry time) and to print the sterilization of one of the 40 previous cycles, the operator can enter three sub-directories and obtain the required data. -
Page 34: Parameters
6.2. Parameters This directory enables the operator to watch and change the cycle’s parameters. Therefore it is necessary to choose the required cycle before entering the "MENU" directory (see "operating instructions"). For seeing or changing the parameters proceed as follows: This CYCLE PARAMETERS screen is displayed when entering the "PARAMETERS"... -
Page 35: Setting The Clock
6.3. Setting the Clock This directory enables the operator to set the time and date. This SET CLOCK screen is displayed when entering the directory: When entering the SET CLOCK display, the time and date are displayed. The curser is blinking on the "hour" digit. The time is displayed in the upper row in the form “hh:mm:ss”. -
Page 36: History
6.4. History This directory enables you to print the 40 previous cycles. This HISTORY screen is displayed: When entering the HISTORY display, the following screen is displayed. 1. Choose the required cycle according to its number (Log Load Nu) with the UP and DOWN key 2. -
Page 37: Printer
PRINTER 7.1. Printer Output The printing is made on thermal paper with 24 characters per line and contains the following information: • Software version • Real time • Selected program • Sterilization pressure • Sterilization temperature • Sterilization time • Dry time When the sterilization cycle begins the printer starts printing the above data. - Page 38 PRINTER OUTPUT DESCRIPTION Operator: To be filled in manually by operator Time: 17:09:08 Time sterilization cycle ended Date: 13/02/2006 Date sterilization cycle ended. CYCLE ENDED! D 00:48:46 077.4 036.2 The time, temperature and pressure during drying. Prints drying data every 3 minutes. D 00:30:46 104.8 109.2...
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Page 39: Printer Handling
7.2. Printer Handling 7.2.1. Maintenance Wipe off the soiling on the printer surface with a dry soft cloth with a weak neutral detergent. After that, wipe the printer with a dry cloth. 7.2.2. Setting paper Fig. 1 1. Open the printer's cover door (3) by pulling it at the left bottom corner (2). - Page 40 Notes on treatment of the thermal papers: • Store the papers in a dry, cool and dark place. • Do not rub the papers with hard substance. • Keep the papers away from organic solvent. Cautions Never disassemble the printer. Failure to follow this instruction may cause overheating or burning of the printer or the AC adapter.
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Page 41: Installation
INSTALLATION 8.1. Placing CAUTION: The sterilizer must be placed on a rigid and leveled surface. The stand must be able to withstand the load of the device and loaded material. 1. Counter top able to support 80 kg. 2. Counter space minimum 55cmW x 65cmD (22”W x 25”D) * (see unit dimensions) 8.1.1 Placing the Autoclave... -
Page 42: Filling The Mineral-Free Water Reservoir
8.3. Filling the Mineral-Free Water Reservoir. 1. Open the door (1). 2. Pour water, gently, into the front funnel (2) until it reaches the required level (3) on the side gauge. It is preferable to use a carafe Please note that the side gauge is divided into three sections. The bottom red section (4) indicates that the water level in the reservoir is too low. -
Page 43: Preparation Before Sterilization
PREPARATION BEFORE STERILIZATION The purpose of packaging and wrapping of items for sterilization is to provide an effective barrier against sources of potential contamination in order to maintain sterility and to permit aseptic removal of the contents of the pack. Packaging and wrapping materials should permit the removal of air from the pack, penetration of the sterilizing water vapor into the pack and removal of the sterilizing vapor. -
Page 44: Packs
11. Place a sterilization indicator strip in each tray. 12. Place instruments with ratchets opened and unlocked or clipped on the first ratchet position. 13. Disassemble or sufficiently loosen multiple-part instruments prior to packaging to permit the sterilizing agent to come into contact with all parts of the instrument. -
Page 45: Tubing
1. Wrapped instruments should be packed in material that promotes drying such as autoclave bag, autoclave paper. 2. It is highly recommended to utilize the Tuttnauer Pouch Rack. This rack allows the operator to place pouches on their side, thus increasing the capacity of the autoclave significantly and promoting better drying of the instruments. -
Page 46: Operating Instructions
OPERATING INSTRUCTIONS It is recommended to perform a B&D test cycle at the beginning of each working day. 10.1. Turning on the autoclave • To start the system, press the main white switch (1) on the right side of the autoclave. •... -
Page 47: Operations
10.4. Operations • Hold the opening handle in open position, while pushing the door until it comes to close position, then release the handle. (The open door symbol is replaced by the next load number). • Select the program UP key: next program DOWN key: previous program •... -
Page 48: Maintenance Instructions
MAINTENANCE INSTRUCTIONS 11.1. Preventive and Scheduled Maintenance The maintenance operations described in this chapter have to be fulfilled periodically to keep the device in good condition and to reduce the breakdown time to a minimum. The user can easily execute these operations in accordance with further instructions. - Page 49 11.1.3 Periodically 11.1.3.1 By the operator Once a month, activate the safety valve (see para. 11.5). Once a month clean the strainer as per para. 11.6. Cleaning frequency may be reduced according to experience. Replace the air filter, every 6 months or after 1000 cycles (the shorter period) according to para.
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Page 50: Draining The Reservoirs
11.2. Draining the Reservoirs (Applies to the clean-water reservoir and to the waste-water reservoir) To drain the reservoir, use item (5) with the plastic hose (6) attached to it (supplied with the autoclave). Insert part (5) into valve (3) and press it until you hear a “click”. The drain valve is open. -
Page 51: Replacing The Air Filter
11.3. Replacing the Air Filter In order to “break” the vacuum, at the end of the dry phase, filtered atmospheric air enters the chamber via a solenoid valve. The filtration of the air is performed by the bacteriological filter that is placed at the inlet of the chamber, through a solenoid valve. -
Page 52: Replacing The Door Gasket
11.4. Replacing the Door Gasket To avoid injuries replace the gasket while the autoclave is cold. Pull off the gasket from the door groove and install the new gasket referring to the drawings as above points 1, 2 and 3. CAUTION! See drawing below for the right direction of the gasket. -
Page 53: Checking The Safety Valve
11.5. Checking the Safety Valve (See "front view"). In order to prevent the safety valve from blockage, it is necessary to allow the steam pressure to escape through it (every month). The safety valves are located in the mineral-free water reservoir. To avoid injuries begin this check while the autoclave is cold. - Page 54 11.5.2 PED-approved type safety valve 1. Operate the sterilization cycle according to the manual. 2. Allow a pressure of approx. 200 kPa (29-psi) to build up in the generator and the chamber. 3. Remove the water reservoir cover. 4. Turn the pressure relief nut clockwise for 2 seconds. Verify steam escapes from the valve.
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Page 55: Cleaning Water Strainer
11.6. Cleaning water strainer CAUTION! Before proceeding, Make sure that the electric cord is disconnected and there is no pressure in the autoclave. CAUTION! Do not touch the strainer shortly after operation. Touching the hot strainer’s cover may cause severe injuries. If maintenance operation is performed while strainer cover is hot, use heat resistant gloves to avoid injuries. -
Page 56: Troubleshooting
TROUBLESHOOTING Only technical personnel having proper qualifications and holding technical documentation (including a technician manual) and adequate information are authorized to service the apparatus. Problem Solution • Display is not Verify that the main switch is in the ‘On’ position. activated •... -
Page 57: Tray Handle
TRAY HANDLE CMT240-0001 POUCH RACK ACS215-0008 TRAY TRY240-0001 TRAY HOLDER TRH254-0001 Page 55 of 56... -
Page 58: Spare Parts List
SPARE PARTS LIST PART NUMBER DESCRIPTION FIL175-0042 Filter, Air, 0.2 Micron, Model 50mm D THE002-0010 Paper, Roll, Printer DPU30 ACCESSORIES PART NUMBER DESCRIPTION ACS215-0008 Pouch rack CMT240-0001 Handle, Tray GAS084-0007 Drain P.V.C. Tube, 8x12 THE002-0009 Printer, DPU30 TRH254-0001 Holder, Tray 11" WIR040-0002 Cable, Electric, Plug + Socket 230V 10A, EUR Page 56 of 56...
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