Do you have a question about the T-Edge 10 and is the answer not in the manual?
Questions and answers
Kim Moss-Allen
April 2, 2025
Message on our T-Edge 10 Table Top Steam Sterilizer says "Time to clean the exhaust filter in your devise." Manual has no mention of exhaust filter. Is this the "drain filter?"
1 comments:
Mr. Anderson
April 2, 2025
No, the exhaust filter message is not referring to the drain filter. The drain filter (P/N: CMT511-0048) is specifically located at the chamber bottom and is replaced using an M14 wrench. There is no indication in the provided context that the exhaust filter and the drain filter are the same component.
Table of Contents GENERAL INFORMATION ......................6 ........6 ANUFACTURER AND UROPEAN UTHORIZED EPRESENTATIVE NFORMATION ................6 PPLICABLE EGULATION AND UALITY TANDARDS 1.2.1 And in consideration with: ..................... 7 ..........8 EGEND FOR YMBOLS APPEARING ON THE ABELS AND IN THIS ANUAL ....................
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....................31 ILLING WATER IN THE RESERVOIR 1.14 ..........32 EE THE REQUIREMENTS CONCERNING ATER UALITY ECTION ....................... 32 ETTING ATE AND ........................33 ATE AND B ........................35 LASS LASS B ......................37 ETTING CLASS AND CLASS CONTROL PANEL ........................41 ...................
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..................83 HAMBER CLEAN LEANING PROCEDURE FACTORY CODES FOR END USER ................89 List of Tables Table 1 - Device labeling ..........................9 Table 2 -Device Properties ........................14 Table 3 - Device Electrical Data ........................ 15 Table 4 - Utility Requirements ........................15 Table 5 - Water Quality ..........................
1 General Information Manufacturer and European Authorized Representative Information T-Edge 10 Autoclave is manufactured by Tuttnauer Ltd., Located Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel. Tel: +972-2- 9904611 The American Authorized Representative is: Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA. ...
ANSI/AAMI ST55:2016 Tabletop steam sterilizers IEC 61010-1 3.1 Edition, January 2017 Safety Requirements for electrical equipment for measurement control and laboratory use. EN 61010-2-40: 2015 Safety requirements for sterilizers and washer- disinfectors used to treat medical materials. EN ISO 15223-1: 2016 Symbols for use in the labeling of medical devices. EN 1041: 2008 + A1:2014 Information to be supplied by the manufacturer of medical devices EN 60529:1992 + A2:2013 Degrees of protection provided by enclosures...
Legend for Symbols appearing on the Labels and in this Manual Manufacturer European Authorized Representative Year of Manufacturing Catalog Number Serial Number Consult the Operation and Maintenance Manual (User Manual) before use IP31 Ingress Protection European compliance Mark of compliance with the European Medical Device Directive (Number xxxx identifies the Notified Body that performed the examination) European compliance Mark of compliance with the European...
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 Manual (User Manual) Caution! Hot Surface Table 1 - Device labeling General Description of the Device The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and...
The device features built-in memory to record up to 999 sterilization cycles. These can be exported to a USB device to be transferred to a PC. The device has a built-in Network Port for use with optional Tuttnauer’s R.PC.R software when connected to your local network.
Intended Users The T-Edge 10 tabletop autoclave is intended for use by hospital personnel and other medical personnel as well as laboratory personnel. All autoclave users must receive training in proper usage from an experienced employee. Every new employee must undergo a training period under an experienced employee.
All transportation charges must be paid both ways by the owner. For technical information or service please contact us at: Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA. Tel (631) 737 4850, (800) 624 5836, Fax: (631) 737 0720 Tuttnauer Ltd., Har –...
1.11.2 T-Edge10 fit into sterilization center cabinet - recommended dimensions: To allow adequate cooling & ventilation of the autoclave placed inside the sterilization center Cabinet, the following T-Edge10 Cabinet sizes are recommended: Width - 22.85”- 23.65”/58-60cm; Height – 22.25”- 22.65”/56.5-57.5cm; Min. Depth 24.9”- 25.2”/63.2-64cm 1.11.3 Device Properties...
1.11.4 Device Electrical Data Property Value Total Power 2000W Voltage 1Ph / 230 VAC Amperage Protection against Class I (IEC 60601-1) electrical shock Mains supply fluctuation +/- 10% Frequency (Hz) 60Hz Table 3 - Device Electrical Data 1.11.5 Utility Requirements Property Value Mineral-free water...
Device Environmental Information The peak sound level generated by the autoclave is 67dBa with background noise of 48dBa during sterilization stage, and 65dBa during drying stage. The total heat per hour transmitted by the autoclave is <200Wh. Requirements with concern to Water Quality The distilled or mineral-free water supply to the autoclave shall be according to the table below: TABLE1: Suggested Maximum Limits of Contaminants in Water for Steam...
1.13.1 Tap water supply The range of hardness value 0.7-2.0 mmol/l (70- 200 mg/l CaCO3) The use of soft water is strictly forbidden! Please consult a water specialist! Note: We recommend testing the water quality once a month. The use of water for autoclaves that does not comply with the table above may have severe impact on the working life of the sterilizer and can invalidate the manufacturer’s guarantee.
2 Safety Principle Safety Warnings and Precautions Always operate the autoclaves strictly as instructed in this user manual. Caution! Instruments should not be loaded into the autoclave to be sterilized unless Steam Sterilization is instructed in their User Caution! Manual. The instructed Steam Sterilization Program should be verified against the programs available in this autoclave.
Safety Notes All new autoclave users must undergo a period of training in proper usage under an experienced employee. Before initial use, check the autoclave chamber to ensure that no packaging materials have been left inside. Before use, check inside the autoclave chamber to ensure that no items have been left from the previous cycle.
3 Content of the Device Package Part Number Part Description Quantity Supplied AMS10-230-W-T T-Duke23 Autoclave DEV000 0663 Aluminum Tray for 10” TRH511-0001 Wire Tray holder for trays or Cassettes TRH511-0004 tray stoppers (to be assembled on tray holder) Tray Handle CMT240-0002 PIP411-0042 Tube for Reservoir Drain...
4 Depiction of System Parts Front View No. Description Description Touch screen Door switches On/off switch Air filter Chamber Door USB socket Door Gasket Door Handle Mineral-free (left) and waste water (right) Mineral-free water reservoir opening reservoir drains Chamber Chamber Table 8 - Front View...
Rear View No. Description Description USB ports Waste outlet Mineral-free inlet (available in AMS10- LAN socket 230-W-T) Cut-off Thermostat Safety valve Circuit breaker on off Aeration Ventilation opening switch Power socket Table 9 - Rear View Mind the Power socket. Keep it and its vicinity dry. Danger of electrocution.
5 Installation Instructions Lifting and Carrying Cautions! Before moving the autoclave, make sure that the electric cord is disconnected from the power, and there is no pressure in the chamber. Drain the water from the reservoir (see draining the reservoir, 8.9) Do not drop the device! To avoid injuries, lifting and carrying should be done with at least two people or by using a fork-lift or any other mechanical aid.
8. Check and verify that the ambient relative humidity does not exceed 9. The operational altitude shall not be over 13123 ft (4000 meters). 10. Ambient pressure shall not be lower than 8.8 psi (60.5 KPa) (if the altitude and temperature are kept in the manufacturer's instructed ranges above, and no forced extreme negative pressure is applied near the autoclave, then ambient pressure of 8.8 psi (60.5 KPa) or higher is guaranteed, as it is a function of altitude and temperature).
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2. Turn ON the semi-automatic ON/ OFF button switch located on the bottom left side of the back panel of the autoclave (see the rear view), and then. Semi- automatic ON/OFF Switch 3. Turn on the ON/ OFF Switch mounted on the bottom left side of the front panel (see the front view).
Clean instruments immediately after use to remove any residue. It is recommended that all instruments be ultrasonically cleaned using Tuttnauer’s Clean & Simple enzymatic cleaning tablets or other suitable solution. After cleaning, rinse instruments under tap water for 30 seconds and pat or air dry to remove residual minerals.
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Launder textile wraps prior to sterilization, thoroughly rinse wraps laundered in chlorine bleach. Chlorine bleach can harm your stainless-steel instrument and the sterilizer. Follow the instrument manufacturer’s instructions on the use of products for cleaning and lubricating instrument that have been ultrasonically cleaned. ...
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Cassettes should be placed on the tray rack in place of the trays. They should not be touching each other or the Chamber walls. There should be about 2.5cm between cassettes or packs for proper steam circulation. If spotting is detected on the instruments it is necessary to determine if the spot is dirt or rust.
7 Operating Instructions The following are the operation instructions. Turning on the Device Plug the power cord into the socket on the rear panel of the autoclave (see the rear view) and into the wall outlet. semi Turn ON the -automatic ON/ OFF bottom Switch located on the rear panel of the autoclave (see the rear view).
Filling Water Cautions! In the beginning of each day, check water level in the reservoir. Note: Improper Water level icon appears when the water reservoir needs to be filled. See the ‘filling procedure’ (7.3 below) and ‘Draining the Reservoir’ ( A general alarm symbol will appear.
The following screen shows that the Waste water tank is empty. Caution! Before filling the reservoir, verify that the autoclave is idle and there is no pressure in the chamber. Filling water in the reservoir Use only water having the characteristics stated in Water Quality. Note: Using tap water will clog the system and invalidate the manufacturer’s guarantee.
The clean water level indicator will change from a red water droplet symbol to a blue water droplet, as shown below: See the requirements concerning Water Quality, in Section 1.14 Setting Date and Time Note: The Initial log-in including setting of drying time as well as other initial parameters will be performed only by a qualified technician upon installation On the main screen, press the menu symbol to open the settings screen.
Set Date and Time Press the Set Date and Time icon to open the Set Date and Time screen. This quick option enables the operator to set the machine date and time. Select day, month and year, as depicted: After adjusting the date and time, the system will automatically restart.
The following tables provide: Table1 for types of sterilization cycles Table 2 provides the T-EDGE 10, Class B sterilization programs. Table 3 provides the T-EDGE 10, Class S sterilization programs. Table 1 — Types of sterilization cycles Class B The sterilization of products as represented by the test loads in the standard.
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Table 2 — Class B: sterilization cycles Cycle Name Sterilization Temp. Pre / Post Vac Unwrapped Instr. 273F 273F Pre / Post Vac Wrapped Pouches 273F 273F Pre / Post Vac Unwrapped Delicate 250F 250F Pre / Post Vac Wrapped Delicate 250F 250F Chamber Clean Bowie and Dick...
Your autoclave contain class S as a standard. If you (the customer) would like to upgrade your system to a class B, please contact Tuttnauer USA representatives or your dealer. Tuttnauer will ask you for the autoclave serial number. In return Tuttnauer will provide you with a code/password.
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3. Press on the required class type. 4. Enter Password. 5. Click on set. 6. Class setting is in progress, press OK.
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The autoclave is now converted to Class B and the screens displayed will have a class B identification. Note: the Class B sign are on screen header. The entire autoclave is now in class B system, a sample of the screens after the conversion to class B, are shown below: Class B i.d...
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Note: It is possible to switch back from class B to class S if desired, following the steps above, by selecting S in step 3.above instead of B. Entering the code password is required.
8 Control Panel The display is a graphic Touch screen LCD panel used to display the autoclave current status, any Operational or Error Messages and for operating the machine. Image 1: Home screen –Program Select Screen This screen will be presented when the autoclave is switched on: Additional programs are accessible by paging using the side arrows:...
Home screen Description and Functions Icon Name Description Home icon immediate use only Menu Menu selection icon Unwrapped 273F Exposed Unwrapped 273F load program Pressure Momentary Pressure in the chamber Temperature Momentary temperature in the chamber Load no. ID Load cycle number Date and time It enables the operator to set the machine date and time screen Water full...
Opening the Device Door This machine is equipped with an electronic door lock. The door is locked when either the system is running a sterilization cycle, or there is pressure in the chamber, or the power is off. If you need to open the door after cycle completes, press the confirm button: Showing Class S In any case, if the door is not locked, it can be opened as illustrated below.
Starting a Cycle It is recommended to perform B&D test cycle at the beginning of each working day. Before each cycle, check visually that the gasket is intact, not loose and clean. Load the autoclave properly (see chapter 6). Choose the appropriate sterilization program. Note: The program can only be selected when the door is open.
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Close the door by both: Pushing the door gently; Turning the handle clockwise while pushing the door until it comes to the closed position, then releasing the handle. When the door is closed, the open-door symbol is replaced with the closed-door symbol...
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Press the Start button to start the cycle. For cycle process description, see Sterilization Cycle Description. Warning! Do not remove the top plastic cover during a running cycle. Hot water / steam may exit! After pressing start, the sterilization process starts Image 3: screen display while "Unwrapped 134"...
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Showing the time left until the end of the process...
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Chamber Chamber pressure temperature Program/ test description: Program icon & name Program/ test description: Sterilization temperature Sterilization time Stop button System status Name of stage Error and operational messages Progress bar Note: For the results of the cycle, see description in paragraph 8.5.
Available Sterilization Programs and Test Programs List of available Sterilization and Test Programs 8.4.1 (refer to sec.8.4.2 for maximal allowed weight of load) Sterili- zation Dry time Type of use Cycle Icon Name Temp Load type time (minutes) type (min.) Unwrapped immediate 1 (default)
8.4.2 Maximum Load Weight per Load type Load type Maximum Suitable for programs Load Weight Textile, porous 3.0 lbs (1.5kg) Wrapped Solid Unwrapped 13 lbs ( 6.0kg) Unwrapped Solid Wrapped 7 lbs (3.5kg) Wrapped Table 12 - Maximum Load Weights 8.4.3 Description of the Sterilization Cycle Stages Air-removal stage: Pre vacuum pulses are performed.
8.4.5 Description of Bowie-Dick Test Stages Air-removal stage: vacuum pulses are performed. Heating stage: steam is inserted into the chamber until the sterilization temperature and pressure are reached. Sterilization stage: temperature and pressure are maintained constant at the pre-set level for sterilization time. Fast exhaust stage: steam is exhausted out of the chamber at a fast rate until pressure decreases to ambient pressure.
8.5.2 Cycle Failed In the event of a failure at any stage, the exhaust valve will be opened to release pressure from the chamber, the message "Fail" and a relevant failure message will be displayed on the screen: Warning! The load has not completed a sterilization cycle; therefore, it is not sterile.
Aborting a cycle It is possible to stop the cycle while the autoclave is operating. Press the Stop button at any stage (except exhaust) of the process to stop the operation. If the cycle is aborted, the load is not sterile. A “fail” message will be displayed with an error message explaining the reason for the failure.
Opening the door and Unloading 1. Push the button to confirm the "Successful" or the "error" message to unlock the door. 2. Open the door. Caution! Open the door a little to release the steam from the chamber. Only after the steam escaped, open the door widely.
Checking Waste Water Level When the waste water level is high, the general alarm symbol will appear. A relevant text alarm will appear in the alarms list. This situation is normal, but the operator cannot run a new cycle before draining the waste water reservoir (see ‘Draining the Reservoir’...
To drain the reservoir: 1. See item (5) with the plastic hose (6) attached to it (supplied with the autoclave). Clean Water Waste Water 2. Put the other end of the hose into a drain bucket. 3. Insert part (5) into valve (3) and press it until you hear a click. The drain valve opens immediately.
Note: Technician manual describes the maintenance operations required from qualified technician, every two months and once a year. Should the need arise, technical assistance or a service technician can be requested by either calling your dealer or Tuttnauer Europe. Daily Maintenance Caution! Make sure the autoclave is not hot before cleaning it.
Monthly Maintenance Caution! Make sure the autoclave is not hot before cleaning it. Turn the unit on momentarily to allow the door to be opened. Open the door, unplug the autoclave again, and proceed with cleaning. Clean and descale the chamber. ...
Periodic Maintenance Caution! Make sure the autoclave is not hot before cleaning it 1. Replace the air filter, every 6 months or after 1000 cycles (whichever comes first) according to 12.3. 2. Every 3 months check the door gasket for any signs of physical damage and ask the technician to replace it if there is tear or leakage.
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2. Disconnect the pipe. 3. Connect the new filter. 4. Screw in the new filter. 5. Ensure the new filter is all the way in and seated properly. Note: make sure that the arrow on the filter body points inwards, toward the chamber.
9.4.2 Cleaning the Drain Filter Caution! Make sure the autoclave is not hot before cleaning it Cautions! Before proceeding, make sure that the electric cord is disconnected and there is no pressure in the chamber. Clean the drain filter, every month. The DRAIN filter (1) is located inside the autoclave chamber at the bottom far end, to reach the filter open the autoclave chamber door, remove the tray (see below).
9.4.3 Replacing the Drain Filter Note: If after successive cleaning of the filter the result is not satisfactory proceed to the replacement of the drain filter (paragraph 9.4.3 below). Cautions! Before proceeding, make sure that the electric cord is disconnected and there is no pressure in the chamber. Use scissors to open the filter bag and not sharp blades or pointed instrument.
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3. Unscrew the old Drain filter assembly, using M14 wrench. 4. Remove the old Drain filter assembly. 5. Screw the new Drain filter assembly, (P/N: CMT511-0048) to its place in the chamber bottom, tighten it with the M14 wrench. 6. Ensure the new filter is all the way in and seated properly. 7.
10 Full List of Informative Screen Display Symbols, Operating Messages, Error Messages and Troubleshooting The troubleshooting section is provided in order to enable the user to solve minor malfunctions, prior to contracting our service department. However, only technical personnel having proper qualifications and holding technical documentation (including a technician manual) and adequate information are authorized to serve the apparatus (See TABLES 13 &...
Required Symbol / Message Symbol / Message Description Action (if applicable) Sym- Good Water level (Waste water tank) Full Water level (Waste water tank) Sym- Sym- Alert Press to watch the alert description When cycle is selected it is ---- highlighted in red The "cycle succeeded"...
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Req ID Message Description "Chamber This message is displayed if the temperature in the Msg-130 temperature not chamber > End temperature (120C) or < 2C in range" "Chamber This message is displayed if Chamber pressure <ATM Msg-140 pressure not in pressure-40kPa or >ATM Pressure +10kPa).
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Req ID Message Description This message is displayed if the system cannot reach the "Pressure Time Msg-260 required pressure conditions in the chamber, after preset Error" time, during the air removal stage. Msg-270 Msg-280 "Time Error" This message is displayed if the real time clock is faulty. "Door is open This message is displayed when the door is open: During Msg-290...
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Req ID Message Description If high water demand cycle is chosen (e.g. Prion) and Water tank filling, Msg-390 Parameter>0 (Auto fill) - Then before enabling Start Please wait message presented on GUI For prion cycle in manual water filling configuration, when the water tank is not full the “Start”...
Req ID Message Description Utility issue #3 – If I/O card disconnected during power on Please switch OFF Msg-480 and ON machine’s power switch Time jumped If main system clock changed during the cycle Msg-500 during the cycle Msg-510 No-user log-in If CFR-11 on and no user login Table 13 - Error messages &...
How to set, operate, use and maintain the printer after the first installation. General printer information The printer(s) are optional and can be purchased/ordered from Tuttnauer by the customer, the printers can easily be installed and connected to the autoclave following the instructions below.
Important safety instructions Read all the instructions and keep them for future use. 2. Follow all warnings and instructions on the product. 3. Disconnect the power plug from the AC outlet before cleaning or if fault happened. Do not use liquids or aerosol cleaners. Using a damp cloth is suitable for cleaning.
Installation for the first time Unpacking the printer: 1. Carefully open the printer box (1) and remove the printer packing. 2. Place the printer (2) on the table, and remove the two tapes (3). 3. Remove the rest of the box content which includes USB communication cable (6), electrical power cable (7), CD (5), adapter (8), blue cable (9), and the printer instructions (4).
Open the printer top cover 1. Remove the two tapes bonding the printer body to its cover (1) on each opposite sides of the printer. 2. Pull the two handles left and right (2) simultaneously together forward as shown by the arrows in figure 1.
Loading thermal printer paper roll/ Label roll You can either load a thermal paper roll, or label roll on the printer roll compartment opening. You can also connect two printers to the autoclave, one loaded with thermal paper roll, and the second printer loaded with label roll. 1.
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5. Insert the paper under the two paper guides (item 6) in figure 3 for the paper roll, pull the paper to extend it beyond the printer. Do the same for the label roll (item 6) figure 4. Figure 3 Figure 5 Printer Figure 3 paper roll Figure 4 Label roll.
Connecting the interface cables to the printer 1. Connect the adapter male (1) to the RC-232 Output Port blue cable female plug connection (2), tighten and secure the 2 screws (3) to the adapter. 2. Plug the adapter connected with the blue cable (8) to the printer adapter connection, Tighten the 2 screws (4).
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11.7 Connecting power and interface cables 1. Connect the RC-232 Output Port blue cable (6) to the back of the autoclave (4). 2. Connect the power cable plug connector of cable (6) coming from the printer to the electrical power source on the wall. 3.
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11.8 Starting the printer 1. Press on the button in the front of the printer cover, keep pressing the finger while switching on the printer power at (1) the printer back. (Step 1 and 2 shall be done simultaneously). 2. Switch on the printer power (1) at the printer back, keep pressing the finger in step 1 until the red light bulb in front start flashing.
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11.9 Setting Printer definitions The following are the login procedures for new user: Press on the quick options menu 2. . Press on icon. 3. Enter administration password Select from drop down list. 4. Press Login Enter administration password Select from drop down list 5.
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7. Press on system parameters 8. Select for paper roll printer type 6. Select for label roll label 1. 9. If only the one printer is connected to the autoclave, local=0 or printer=1. The following table gives the various printer possibilities Printer Type Local Only paper roll 6...
The tablet material is a combination of acidic salts and additional cleaning materials. Use one prepacked chamber clean tablet for all T-Edge10 Tuttnauer Autoclave models. Perform chamber clean every week. Chamber Clean Program-Icon Picture...
2. Tablet from packing Close the autoclave door. Fill fully (Approx. 23 liters for T-Edge 10, and 28 Liters for T-Edge 11) clean water reservoir with distilled water only. (Either Automatic or manual filling). For manual filling, select 0, Global select 1 for...
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Chamber Clean Program-Manual fill clean water tank. Chamber Clean Program-Water tank clean & waste...
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10. Select Chamber Clean Program 11. Chamber Clean Program -Start Cycle...
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12. Chamber Clean Program-Water tank alarm 13. Chamber Clean Program -Set manuel mode fill clean water tank...
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14. Please fill water tank to full for start.Chamber Clean Program-Alarm water fill before start, 15. Chamber clean program Stage Cleaning-insert water The chamber clean process last 45 minutes The warming up to 80ºC and hold for 10 minutes at 80ºC, (This stage uses 500ml of water from the clean water reservoir) .Exhaust water from the chamber, goes to air removal , pass to plateau of 3 minutes at 132 ºC and 1 minute drying time.
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Chamber clean program Stage Cleaning-keep After 45 minutes the chamber clean process is completed, the chamber is clean, and the following screen is displayed. Chamber Clean Program-cycle confirm by operator...
Factory Codes for end user Notice: Please, find below Factory Codes for end user. These codes are similar to all T-Edge 10 machines from version 1.0. Level 1 Factory Code 010 7N613IOJT6 Admin - for User Manual Level 1 Factory Code 011...
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Level 1 Factory Code 032 QHR976ZE46 Admin - for User Manual Level 1 Factory Code 033 TMUYMBFBLE Admin - for User Manual Level 1 Factory Code 034 OTEWS95KOU Admin - for User Manual Level 1 Factory Code 035 AOUMETCLQ1 Admin - for User Manual Level 1 Factory Code 036 7Z1X0PZVHD Admin - for User Manual...
Need help?
Do you have a question about the T-Edge 10 and is the answer not in the manual?
Questions and answers
Message on our T-Edge 10 Table Top Steam Sterilizer says "Time to clean the exhaust filter in your devise." Manual has no mention of exhaust filter. Is this the "drain filter?"
No, the exhaust filter message is not referring to the drain filter. The drain filter (P/N: CMT511-0048) is specifically located at the chamber bottom and is replaced using an M14 wrench. There is no indication in the provided context that the exhaust filter and the drain filter are the same component.
This answer is automatically generated