OPERATION & MAINTENANCE MANUAL Electronic Table -Top Autoclaves models 1730, 2340, 2540, 3545, 3850, 3870E 2340, 3850, 3870 EA 2450EK Cat. No. MAN205-0112-003E Rev. D Brinkmann Instruments, Inc., One Cantiague Road. P.O. Box 1019, Westbury, NY 11590-0207, Brinkmann Instruments (Canada) Ltd.
TABLE OF CONTENTS PARAGRAPH PAGE NO. 1. GENERAL 4 2. 1.1 Incoming Inspection 1.2 Warranty TECHNICAL DATA 4 4 5 3. 2.1 Introduction 2.2 Stand – by heating mode 2.3 Environment Emission Information 2.4 Operating Conditions 2.5 Utilities 2.6 Construction 2.7 Symbol Description 2.8 Electrical Data 2.9 Specifications 2.10 Technical Specifications 2.11 Directives and Standards 2.12 Water quality KEYBOARD (keys and display) 5 5 5 6 6 6 6 7 8 9 10 11 14 4. 3.1 Indicator Light Description 3.
TABLE OF CONTENT (Cont.) PARAGRAPH PAGE NO. 7. PREPARATION BEFORE STERILIZATION 32 8. OPERATING INSTRUCTIONS 35 9. MAINTENANCE INSTRUCTIONS 38 10. 9.1 Preventive and Scheduled Maintenance 9.2 Replacing the Air Filter (models EA) 9.3 Draining the Reservoir 9.4 Cleaning Air Jet 9.5 Replacing the Door Gasket 9.6 Checking the Safety Valve 9.7 Replacing the Cartridge Fuse 9.8 Cleaning water outlet strainer 9.9 Cleaning Table Top Autoclaves with Chamber Brite ™ 9.
TABLE OF CONTENT (Cont.) DRAWINGS PAGE NO.
2. TECHNICAL DATA 2.1 Introduction This table-top autoclave is designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, hospitals, laboratories etc. This autoclave is an electrically - heated sterilizer using steam as the sterilizing agent.
1. GENERAL Read the Operating Instructions carefully, before beginning any operation on the autoclave! 1.1 Incoming Inspection Upon receiving your Tuttnauer Autoclave carefully inspect the outside of the shipping carton for signs of damage. If any damage to the carton is found note the location with respect to the autoclave and check that area of the autoclave carefully once it is fully unpacked. Observe packing method and retain packing materials until the unit has been inspected.
2.4 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. ● - Room temperature range 5ºC to 40ºC. ● - Installation Category II. ● - Pollution Degree 2. ● - Maximum relative humidity 80% for temperature up to 31ºC decreasing linearly to 50% relative humidity at 40ºC. ● - Mains supply voltage fluctuations up to +/-10% of the nominal voltage.
2.8 Electrical Data 1730 E 2340 2540 E, EA E, EA 3545 EK E 3850 3870 E, EA E, EA Ampere (A) at 230/240V 4.6 6 6 9.6 10.4 10.4 13 Ampere (A) at 120V 8.8 11.7 11.7 20.
2.9 Specifications Overall Dimensions Model 1730 mm 2340 2540 3545 3850 3870 in mm in mm in mm in mm in mm in A 440 17.4 510 20.0 510 20.0 590 23.2 660 26.0 660 26.0 B 305 12.0 365 14.4 365 14.4 450 17.7 525 20.7 525 20.7 C 455 17.9 540 21.5 545 21.5 566 21.9 695 27.5 875 34.5 D 750 29.5 910 35.8 910 35.8 990 39.0 1155 45.5 1335 53.0 E 560 22.0 630 24.8 655 25.8 755 29.7 815 32.0 815 32.0 F 350 13.8 415 16.4 415 16.4 488 19.
Page 9 of 53 Pages 31.3 x 39.1 (12” x 15”) 38 ª 58 cm. (15" ª 23" ) 38x76 cm (15" x 30") 3850 3870 84 l. (22 US gal) 65 l. (17US gal) 34.4 l (7.8 gal.) 2 2 28 x 67 x 2.5cm ( 11" x 26" x 1" ) 35 x 67 x 2.5 (14" x 26" x 1") 2 28 x 50 x 2.5 cm (11" x 20 " x 1" ) 35 x 50 x 2.5cm (14" x 20 " x 1") 19.8 x 40.8 x 2.2 (7.8 x 16.1 x 1) 25.6 x 40.8 x 2.5 (10.1 x 16.1 x 1) 4 25.4 x 47.5cm 23 l. 17 x 41.5 x 2 cm (10" x 19") (6 US gal.) (6.7" x 16.3" x0.8") 3545 2540 3 3 No. of trays 19 l.
2.11 Directives and Standards Every autoclave meets the provisions of the following Directives and is constructed in compliance with the following Standards: 2.11.1 Technical Directives 1. 2.11.2 2.11.3 Medical device directive MDD/93/42/EEC. Technical Standards 1. A.S.M.E. Code, Section VIII div.1 for unfired pressure vessels. 2. AAMI/ANSI ST-55:2001 Table-Top steam sterilizers. 3. UL61010-1 Safety for Electrical Equipment for Measurement, Control, and Laboratory Use, General Requirements. 4.
2.12 Water quality 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 acceptable contaminants levels in water, for sterilizers Evaporate residue ≤ 15 mg/l Silica ≤ 2 mg/l Iron ≤ 0.2mg/l Cadmium ≤ 0.005 mg/l Lead ≤ 0.05 mg/l Rest of heavy metals ≤ 0.1 mg/l Chloride ≤ 3 mg/l Phosphate ≤ 0.5 mg/l Conductivity ≤ 50 µs/cm pH 6.
FRONT VIEW No.
REAR VIEW EA,EKA only Cut-Out Thermostat Reset button Page 13 of 53 Pages
3. KEYBOARD (keys and display) FRONT PANEL KEYBOARD Note: See section 3.
3.1 Indicator Light Description Programs Indicators Shows the selected program START Shows the system is running a program HEAT The system is currently in the Heating stage STE The system is currently in the Sterilization stage. EXH The system is in the Exhaust stage. DRY The system is in the Dry stage. FAIL Shows the system has failed as a result of either a malfunction, or the STOP key was pressed. A message is displayed on the screen; the reason for failure.
3.2 Description and Functions of the Control Panel Keyboard 3.2.1 program keys (1) Unwrapped Instruments (2) (3) (4) 3.2.2 Wrapped Instruments Liquids (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. Dry Only Pressing this key allows inclusion of the Additional Drying procedure for a period of time determined by the operator. Time range is 0-99 minutes. Other keys (5) TEMP.
(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. Pressing the CLOCK key again moves the cursor to the month, then year and then time (hour, minute, second). At this point the display shows the currently set date and time.
(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” message will be displayed. This key has no function when the system is not in operation and its only use is to manually stop a cycle. In normal working conditions on completion, the system automatically terminates the cycle, without use of this key.
Low Temp. Message is displayed, fail indicator lights and cycle is aborted, if the temperature drops 2.5ºC (4.5°F) below the required sterilization temperature. Possible causes: ♦ Insufficient water in the chamber (see Low water message) ♦ Sterilization time has been set for to long a period ♦ A bad temperature sensor High Temp.
Door Unlock Message is displayed and the DOOR CLOSED LED indicator remains unlit, if the door is improperly closed when the START button is pressed. If the door accidentally opens during any stage of the cycle, the same message appears, the DOOR CLOSED LED indicator will turn off, and the system reacts as if the STOP key was pressed. High Pres. Message is displayed, fail indicator lights up, and the program is aborted if the pressure rises 10psi (0.6Bar) above the required sterilization pressure.
4. STERILIZATION PROGRAMS The autoclave offers 3 sterilization programs, at a temperatures of 121°C (250°F), 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. Liquids B. Accessory program: 4. Dry only Note: The nominal data of the program (default settings) can be changed to fit the needs or a particular office. This is done by means of the TEMP, STE.
4.2 PROGRAM 2 . Wrapped Instruments and Porous Loads For wrapped instruments and materials, when the manufacturer recommends autoclaving at temperature of 121°C (250°F) with a drying stage. Nominal parameters default settings ♦ Sterilization temperature: 121°C (250°F) ♦ Sterilization time: 15 minutes ♦ Dry time: Models EA − 30 minutes. Models E/EK − 60 minutes. Operations sequence: Heating by actuation of electrical heaters until the sterilization temperature is reached.
4.3 PROGRAM 3: Liquids For distilled water, solutions, medicines and other liquid preparations in closed bottles or flasks. Nominal parameters default settings ♦ Sterilization temperature: 121°C (250°F). ♦ Sterilization time: 30 minutes. ♦ Slow exhaust: 15 to 20 minutes. ♦ Drying time: drying is not allowed. Operations sequence: Heating by actuation of electrical heaters until the sterilization temperature is reached.
5.0 PRINTER (Optional) The printer is an optional device. If the autoclave is not equipped with a printer paragraph 5 is not applicable. 5.1 Printer Operation The autoclave is equipped with a character printer, which prints a detailed history of each cycle performed by the instrument (for the record or for subsequent consideration).
PRINTER OUTPUT Autoclave No:01 Load number: 0003 Operator :___________ O.K.
5.2 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: 5.2.1 Gently push the clips for removing the front panel, remove the panel and pull out the printer gently. 5.2.2 Set the paper roll on the shaft (See Figure 1).
6. INSTALLATION INSTRUCTIONS Caution: The sterilizer must be placed on a rigid and leveled surface. The stand must be able to hold the load of the device and loaded material. Note: Make sure while placing the autoclave, to leave space around the machine, to give the technician access to service the machine. 6.1 Electrical The electrical connection should comply with the devices power requirement. It must also comply with local installation and safety rules and regulations.
6.1.2 Setup for units 1730 & any unit with serial number prior to 2003000 Proper adjustment of the chamber pitch is one of the most important things you can do for the sterilizer. Proper chamber pitch insures that among other things the sterilizer will have the proper amount of water in the chamber at the beginning of each cycle. Insufficient water in the chamber at the beginning of the cycle will generate a LOW WATER message at some point during the cycle when the water level becomes to low.
6.2 Automatic Water Filling 6.2.1 For new units 2340, 2540, 3545, 3850 & 3870 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. Press STOP key repeatedly until the message “code xxx” appears on the display. 2.
6.2.3 Checking the automatic fill To check the automatic fill, follow these steps: To check the automatic fill, follow these steps: 1. Remove any water that is in the chamber. 2. Make sure the unit is turned on. 3. Place a collecting vessel under the autoclave's door. 4. With the door open, press and hold the door switch, then press the START key. 5. When water starts flowing into the chamber release the door switch. 6.
6.4 6.5 Loading and unloading the Device 6.4.1 Safety Protective equipment and clothes and other safety instructions should be implemented in accordance with local and national regulations and/or rules! For proper sterilization - Do not overload the chamber. Only autoclavable products shall be used; please refer to the materials or instruments manufacturers instructions for sterilization of unknown materials or instruments. 6.4.
7. PREPARATION BEFORE STERILIZATION The purpose of packaging and wrapping items for sterilization is to provide an effective barrier against contamination during storage, once the items have been sterilized. Instruments to be sterilized must be free from all residual matter, such as blood or organic tissue. Instruments must also be dry and free from mineral deposits. Such substances may cause damage to the instruments themselves or the Sterilizer. 1. 2. 3. 4. 5. 6. 7. 8. 9.
13. Verify that packaging methods are in accordance with the good practice approach and the packaging materials used are in agreement with applicable standards 14. Empty canisters should be placed upside-down in order to prevent the accumulation of water. 15. Do not overload the Sterilizer trays. Overloading will cause inadequate sterilization & drying. 16. Allow a distance of approximately 1" between trays to permit steam circulation. 17.
21. Liquids should only be sterilized in heat proof glass. The beaker should only be filled 2/3 full and the lid should be on loosely to allow for expansion. 22. 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.
8. OPERATING INSTRUCTIONS It is important to clean the hole of the air jet, as described in sec. 9.3 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). 2. Plug the power cord into the back of the autoclave and into the wall outlet. 3.
8. During any program that has a drying stage scheduled, the dry stage begins after the steam exhaust stage. Models EA are equipped with an air compressor that during the drying stage, draws air through a HEPA filter (0.2µm), 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. 8.
MAINTENANCE INSTRUCTIONS Page 37 of 53 Pages
9. MAINTENANCE INSTRUCTIONS 9.1 Preventive and Scheduled Maintenance The maintenance operations described in this chapter need to be followed as indicated to keep the device in good working condition. The instructions that follow can easily be carried out by the office personnel and do not require a service technician. Should the need arise technical assistance or a serve technician can be requested by either calling your dealer or Tuttnauer USA. 9.1.
9.2 Replacing the Air Filter (models EA) To facilitate drying the instruments with the door of the chamber closed, models EA are 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.
9.3 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. 1. Connect the silicone hose, supplied with the autoclave, to drain into a bucket. 2. Turn drain valve counter clockwise to the open position. 3. Fully drain the reservoir. 4.
9.4 Cleaning 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. A clogged air jet will result in receiving the error message “Low Heat”.
9.5 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.
9.6 Checking the Safety Valve (Located in the water reservoir) In order 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. Operate the sterilization cycle according to the manual. 2. Allow a pressure of approximately 30 psi (260 kpa) to build up in the chamber. 3. Turn the unit off 4.
9.7 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 counter clockwise ¼ turn, and pull it out. Insert a new fuse into the holder and turn the cover clockwise until locked. Make sure that the correct fuse is installed 1. Water Pump Fuse: 1.25 amps 2. Air Pump Fuse: 2.0 amps for 120V 1.
9.8 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 1. The strainer’s cover is HOT Do not touch the strainer’s cap, mounted on the exhaust line, during and shortly after operation. Touching the hot strainer’s cap may cause severe injuries. 2. If maintenance operation is performed while strainer cap is hot, use heat resistant gloves to avoid injuries. 1. Open the strainer cap. 2.
9.9 Cleaning Table Top Autoclaves with Chamber Brite ™ CHAMBER BRITE ™ is a cleaning and descaling agent designed specifically for the cleaning and removal of water deposits, oxides and other sediments that are found in steam sterilizers. The material is a combination of acidic salts and additional cleaning materials. Chamber Brite ™ autoclave cleaner has been formulated specifically to be a fast, powerful and easy to use cleaner for steam sterilizers.
10. Remove the tray holder; rinse and wipe the interior of the chamber with a damp cloth. 11. Fill the reservoir with distilled water or mineral free water only. 12. Press the manual water fill button and allow a small amount of water (2-4 ounces) to fill chamber and flush out the fill tube. Remove water from chamber. 13. The instrument is ready to use. IMPORTANT: DO NOT sterilize instruments during the cleaning process!!! CAUTION: Keep out of reach of children. Contains mildly acidic ingredients.
9.10 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. It is easily cleaned using a damp cloth or sponge, you may use a mild soapy solution if you like. It is important to wipe the sides of the sensor as well as the tip, to remove any dirt or debris that may have built up.
Page 49 of 53 Pages ‘Low Heat’ is displayed ‘Low Water’ is displayed ‘Low Pres’ is displayed 3. 4. The machine is not responding Problem 4.3 4.1 4.2 3.3 3.1 3.2 2.2 2.1 1.4 1.3 1.2 1.1 Clean the water level electrode inside the vessel. (see sec 9.10) Check that the door is fully closed, the door gasket is seated and there is no steam leakage. Replace the door gasket if necessary. (see sec. 9.5 Replacing the Door Gasket) Check the leveling of the machine. (see sec. 6, Installation).
Page 50 of 53 Pages If equipped with a printer 10. When the machine is switched on, the printer gives paper feeds all the time. Make sure the ‘feed button’ on the printer is not stuck. 10.1 9.2 Make sure the paper is inserted in the printer. (see sec. 5.2, Printer handling) Switch off the machine and switch it back on while pressing the feed button on the printer. If the printer prints a test printout, the printer is O.K. and there is a problem with the electronics.
Page 51 of 53 Pages 13.1 14.1 13. Water does not exit chamber due to clogged outlet strainer. 14. The drain is clogged Drying cycle may be too short. (see sec 4) Autoclave may be overloaded. (see sec 7) The chamber strainer may be clogged (see sec 9.8). The HEPA filter may be clogged (see sec 9.2) Water sensor may be dirty (see sec 9.10) Wall outlet voltage may be to high Items may be touching the walls or bottom of the chamber.
Page 52 of 53 Pages 19.1 20.1 20.2 21.1 22.1 22.2 23.1 23.2 23.3 23.4 20. Autoclave takes too long to heat up 21. Loud noise coming from reservoir 22. Drying takes too long 23. Chamber not filling 18.2 18.3 18.1 19 Keyboard does not respond 18. Instruments are rusting Problem check water level in reservoir. Check for an obstruction at the bottom of the reservoir blocking the pick up tube Clean the water sensor (see sec 9.
Page 53 of 53 Pages 25.1 25. Trays and rack very dirty If the problem persists, contact your dealer or Tuttnauer USA for further assistance. Remove the trays and rack and clean as per instructions in sec 9.1.2 24.1 Use Chamber Brite ™ to clean the autoclave, very dirty machines may require two cleanings. (see sec 9.9) Solution 24.