Table of Contents Paragraph Page No. 1. GENERAL INFORMATION 1.1 Manufacturer and US Official Correspondence Information 1.2 Applicable Regulation and Quality Standards 1.3 Legend for Symbols appearing on the Labels and in this Manual 1.4 General Description of the Device 1.5 Intended Use 1.6 Intended Users 1.7 Warranty Description...
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7.2 Filling Water 7.3 Filling water in the reservoir 7.4 See the requirements concerning Water Quality, in Section 1.12 7.5 Setting Date and Time 7.6 Class S and Class B 7.7 Setting Class S and Class B 8. CONTROL PANEL 8.1 Home screen Description and Functions 8.2 Opening the Device Door 8.3 Starting a Cycle...
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12.2 System Clean Cleaning Procedure Page III...
) Tel (631) 737 4850, (800) 624 5836, Ê Fax: (631) 737 0720 1.2 Applicable Regulation and Quality Standards The life cycle of Tuttnauer's T-Edge VET-11 is in compliance with the following regulation and quality standards: Global Unique Device Identification...
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Safety requirements for electrical equipment for IEC 61010-1 / UL 61010-1: measurement, control, and laboratory use – Part 1: General requirements Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2- IEC 61010-2-040: 040: Requirements for sterilizers and washer- disinfectors used to treat medical materials EN 613261-1: EMC Requirements for Electrical Equipment...
1.3 Legend for Symbols appearing on the Labels and in this Manual Manufacturer Year of Manufacturing Model Number Serial Number Consult the Operation and Maintenance Manual (User Manual) before use 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)
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Fragile (during transport and shipment) A warning or precaution as detailed in the Operation and Maintenance Manual (User Manual) Caution! Hot Surface Page 4...
USB device to be transferred to a PC. The device is Wi-Fi compatible, enabling remote tracking and monitoring by technicians and HQ services. The device has a built-in Network Port for use with optional Tuttnauer’s R.PC.R software when connected to your local network.
Tuttnauer’s obligation is limited to the repair or replacement of parts for the device. This warranty will be void if the unit is not purchased from an authorized Tuttnauer dealer. No other warranties or obligations are expressed or implied.
1.9 Customer Inspection Upon Receival of the Device 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.
1.10 Device Specifications 1.10.1 Device Overall Dimensions - T-Edge VET-11 1.10.2 T-Edge VET-11 fit into sterilization center cabinet - recommended dimensions: To allow adequate cooling & ventilation of the autoclave placed inside the sterilization center Cabinet, the following T-Edge VET-11 cabinet sizes are recommended: Width - 23.65”- 24.40”/60-62cm;...
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1.10.3 Device Properties Property Dimension Width ~19.7"(50cm) Height ~19.7"(50cm) External size ~22.8" (58 cm) supporting common install base carry a Depth ~23" (60 cm) counter top Diameter ~11"(28 cm) Depth ~18"(46 cm) Chamber Volume ~913 Ounces (27.2lit) Usable chamber space ( ~685 Ounces / ~20.5 L) Max.
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Property Dimension Max. water Up to the float ~144 Ounces (4.25lit) volume Min. water ~33.8 Ounces (1lit) volume The volume used by the sterilization ~30 Ounces (~900ml) for cycle/load Wrapped 273F + virus protect having the highest steam consumption Waste water ~182.6 Ounces (5.4lit) tank volume Used (waste)
1.10.5 Utility Requirements Property Value Mineral-free water See table in Water Quality Mineral-free water inlet Optional - 1/2" automatic Drain Optional - 3/4", withstanding temp. of 80°C Power supply * 1 phase, 120VAC ±10%, 50/60Hz Recommended circuit breaker * According to the local network. Caution! In order to avoid any injury by electrical hazard, it is recommended that a ground fault protection device (GFCI) be installed in the electrical panel feeding the autoclave (local codes may make...
1.12 Requirements with concern to Water Quality The distilled or mineral-free water supply to the autoclave shall be according to the table below: Suggested Maximum Limits of Contaminants in Water for Steam Sterilization per EN13060 Substance Feed Water Condensate Evaporate residue ≤...
2. Safety Always operate the autoclaves strictly as instructed in this user manual. Caution! The device is designed to carry safeguards against cybersecurity threats. If you fear the device has been compromised, immediately contact the authorized representative. Attention! Instruments should not be loaded into the autoclave to be sterilized unless Steam Sterilization is instructed in their User Manual.
2.1 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 AMS11-120-W-T-TV T-Edge VET-11 Autoclave TRY510-0001 Aluminum Tray for 11” Wire Tray holder for 5 trays or TRH510-0001 Cassettes, USA CMT240-0002 Tray Handle PIP411-0042 Tube for Reservoir Drain Cable, Plug + Socket 110V...
4. Depiction of System Parts 4.1 Front View Description Description Mineral-free water reservoir opening ON/OFF switch Touch screen Chamber Mineral-free (left) and waste water Air filter (right) reservoir drains Chamber Door Door switches Door Gasket Door Handle Page 16...
4.2 Rear View Description Description Aeration ventilation opening LAN socket ON/OFF switch Safety valve Power socket Mineral-free inlet USB port Waste outlet Warning! Mind the power socket. Keep it and its vicinity dry. Danger of electrocution. Page 17...
5. Installation Instructions 5.1 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 8.12 Draining the Reservoirs) 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.
5.3 Connections to Utility Supplies Check and verify that the power supply is a 1 phase, 120VAC ±10%, 50/60Hz. Check and verify that the electrical net is protected by a current leakage safety relay. The autoclave defines Class A - devices are those that are marketed for use in a commercial, industrial, or business environment.
5.5 Initial Operation of the Device Note: Remove all packaging material before turning ON the device. Plug the power cord into the power socket. Warning! Mind the power socket. Keep it and its vicinity dry. Danger of electrocution. Turn ON the semi-automatic ON/ OFF button switch located on the bottom left side of the back panel of the autoclave.
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Turn on the ON/ OFF Switch mounted on the bottom left side of the front panel. When you turn on the autoclave, it will automatically warm up. Warning! Be careful the surfaces may be hot! 5. Fill the Mineral Free Water Reservoir with water meeting the quality specs (see Water Quality and Filling the Mineral-Free Water Reservoir).
5.6 Before starting the Autoclave Note: The device automatically resets the Atmospheric Pressure when turned on. Open the Autoclave door for 2 minutes and verify that the ambient temperature is below 113°F. To reset the Atmospheric Pressure manually: In the Quick Option screen, press the Settings icon , then browse to Maintenance/Reset atmospheric pressure.
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This data is used for: Monitoring Viewing and downloading device history Software updates while validating the integrity of the update (applicable for users with Tuttnauer code) The data is backed-up on the device main board. Note: In case of connection failure, the data may be exported manually.
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Press The Wi-Fi is connected successfully. Press Checking the device Version information. 1. In the Quick Option screen, press the Info option 2. Select the Version information. 3. The Version information is displayed. For an example, see below: Page 24...
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4. Press on the to return to the Info screen. 5. Select the Play tutorial option to watch the T-Edge Instructional Video 6. The T-Edge Instructional Video can be accessed below: https://tuttnauer.com/t-edge10/en/video/how-to Page 25...
The item manufacturer’s instructions always supersede any other instructions. 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.
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steel trays (mixing will result in damage to the instruments or trays from the oxidation of these materials). Load items within the boundaries of the tray so that they do not touch the chamber walls or fall off when the tray is moved. Items should not be allowed to touch the walls of the Chamber as the hot metal can damage the item.
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cleaned or that the instruments were not adequately cleaned or dried prior to sterilization. If removal of the spot reveals pitting, then the spot is most likely rust. Rust spots on an instrument are not uncommon on inexpensive instruments. It may also be an indication that the instruments were rinsed in tap water with a high mineral content.
7. Operating Instructions 7.1 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. Turn ON the semi-automatic ON/ OFF bottom Switch located on the rear panel of the autoclave. Turn ON the ON/OFF switch mounted under the cover on the front of the autoclave.
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Proper Water level icon appears when the water reservoir is properly filled. The water level icon appears when the water level in the reservoir is full. When this icon appears, do not fill water! The following screen shows that the Waste water tank is full. The following screen shows that the Waste water tank is empty.
7.3 Filling water in the reservoir Note: Use only water having the characteristics stated in Water Quality. Using tap water will clog the system and invalidate the manufacturer’s guarantee. To fill water in the reservoir: Lift up the water reservoir cover (see below). Pour water into the reservoir through the water filter on top of the autoclave unit.
7.5 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 Quick Option screen. From the Quick Option screen, press the Set Date and Time icon Note: The only functionality to be performed by the user (on a regular basis) is setting the date and time.
7.6 Class S and Class B Class B: General description Class B (that conform to the European standard) mainly provides deeper vacuum in the autoclave chamber than Class S, therefore, includes a more complete air removal from the most difficult load types. It allows the system to perform vacuum in difficult hollow or porous instruments and perform effective sterilization of these materials.
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Table C — Class S: sterilization programs Cycle Name Sterilization Temp. 269.6°F Unwrapped Instr. 270F Wrapped Pouches 270 F 269.6°F Unwrapped Delicate 250F 249.8°F Handpieces 270F 269.6°F System Clean Rapid Wrapped Pouches 269.6°F 270F Page 35...
Your autoclave contains 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 Class type factor (accessible from the S/B screen). In return Tuttnauer will provide you with a code/password.
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2. Press to complete conversion. The autoclave is now converted to Class B and the screens displayed will have a Class B identification. Note: The Class B sign is on the 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: 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 S&B.
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: Page 38...
8.1 Home screen Description and Functions Icon Name Description Home icon Main screen selection icon Menu Menu selection icon Unwrapped Instr. 270F Unwrapped Instruments 269.6°F load program Pressure Momentary Pressure in the chamber Temperature Momentary temperature in the chamber Counter no. ID Daily / General counters Full water level The Water is full in the reservoir...
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Icon Name Description Warnings Indicates the Alerts Unwrapped Delicate Unwrapped Delicate 249.8°F load program 250F Side arrow left Paging backward to the previous programs Wrapped Pouches Wrapped Pouches 269.6°F load program 270F Duplicates a sterilization program and enables modifying the settings. Custom Note: This is not an FDA approved program! Bowie and Dick Test...
8.2 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 If the door is not locked, it can be opened as illustrated below.
8.3 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.
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The next screen will prompt the selected program information. 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 8.
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Image 3: Screen display while "Unwrapped Instr. 270F" sterilization program is in progress. Note: For the results of the cycle, see description in section 8.5 Page 45...
8.4 Virus Protect program The Virus Protect is a program that eliminates viruses and is performed prior to a sterilization cycle. Note: The Virus Protect is not for use for Textile and Porous programs. 1. Select from a sterilization cycle, the Virus Protect option. 2.
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Note: If the Virus Protect program fails, the confirmation message below appears. After pressing on OK in this message, the system will release air outside of the autoclave. Page 47...
8.5 Available Sterilization Programs and Test Programs This device is not a medical device and not intended for medical use. Class B Page 48...
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Class S Note: At the end of the cycle, visually inspect and verify that the instruments are dry. If moisture is detected on the instruments, increase the dry time by clicking , before restarting the cycle. 8.5.1 Maximum Load Weight per Load Type Warning! Do not overload! Exceeding the maximum load weight (see Class B and Class S tables below), may result in moist instruments, consequently leading the user to increase the dry time.
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Class S Load type Maximum Load Weight Suitable for programs Handpieces 5 units Handpieces Solid Unwrapped ~17.6 lbs ( 8.0kg) Unwrapped Solid Wrapped ~9.9 lbs (4.5kg) Wrapped 8.5.2 Description of the Sterilization Cycle Stages Air-removal stage: Pre vacuum pulses are performed. For wrapped cycles, there are 2-3 pulses and the vacuum are deeper.
8.6 Cycle Succeeded / Cycle Failed Notifications and Follow-on 8.6.1 Cycle Succeeded When the cycle has ended successfully, the following "Successful" message is displayed: Push the confirm button to confirm the "Successful" message. Proceed to chapter "Opening the door and Unloading". 8.6.2 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"...
8.7 Aborting a cycle It is possible to stop the cycle while the autoclave is operating. Press 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.
Custom programs are not FDA approved! Validation of the sterilized cycle is the user's responsibility. T-Edge VET-11 offers the user a customized program, adjusted in order to sterilize items that cannot be sterilized in any of the preceding default programs.
3. Press to begin the customized cycle. 8.9 Cycles history The Cycles history menu enables printing a specific cycle. On the Quick Option screen, press the Settings icon , then browse to Advanced options / Handle cycles / Cycles history The following screen is displayed with the status of the cycle.
8.10 Opening the door and Unloading Press to confirm the "Successful" or the "error" message to unlock the door. 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.
8.12 Draining the Reservoirs This procedure applies to the mineral-free water reservoir (left) and to the waste-water reservoir (on the right). Note: Improper Water level icon appears when the water reservoir needs to be filled or drained. The drain valves are located on the front right side of the autoclave after the door is opened. To drain the reservoir: See item (5) with the plastic hose (6) attached to it (supplied with the autoclave).
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Caution! Never reuse waste water. If the drained reservoir is the clean-water reservoir, fill reservoir with distilled water until it reaches the full level. (Approximately 219 Ounces /6.5 liters). The autoclave is now ready for use. 8.12.1 Waste water draining Caution! Waste water should be brought into the public net in accordance with the local rules or requirements i.e ONLY NON-HAZARDOUS LIQUIDS SHALL BE DISPOSED IN PUBLIC SEWAGE!
The instructions that follow can easily be carried out by the operating personnel and do not require a service technician. Should the need arise, technical assistance or a service technician can be requested by either calling your dealer or Tuttnauer U.S.A. 9.1 Daily Maintenance Caution! Make sure the autoclave is not hot before cleaning it.
9.3 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. If the autoclave is only used occasionally, drain the water from the mineral free water reservoir once a week, and refill with fresh mineral-free water or distilled water.
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The AIR filter is located under the mounted cover. Unscrew the filter . Disconnect the pipe. Connect the new filter. Screw in the new filter. 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. Make sure that you don’t bend the filter pipe when reattaching it.
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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). Open the autoclave chamber door and remove the tray (2), (see above). Clean with a soft cloth the filter and the area around the filter.
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Caution! Make sure the autoclave is not hot before cleaning it 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). Replace the old DRAIN filter, by the new DRAIN filter (P/N: CMT511-0048).
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.
Symbol / Message Symbol / Message Required Action (if applicable) Description Alert Press to watch the alert description The "Successful" message and symbol are displayed when the cycle ends successfully. The "Fail" message and symbol are displayed when the cycle Try performing a new cycle in order failed either due to intended cycle to sterilize the load.
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Message Description Chamber pressure < Ambient pressure - 5% This message is displayed if I/O card is disconnected (while "I/O card is not connected" a cycle is running or not) This message is displayed if the temperature drops below the sterilization temperature - Chamber Low Temperature "Chamber low temperature error"...
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Message Description Time elapsed exceeded the "time service counter" parameter This message is displayed if power down has occurred during the cycle. The message will appear in the next "Power Down" power up. (this message will be printed after the autoclave is turned on) This message is displayed if Vacuum pressure fails to reach the required value (parameter Target Pressure)
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Message Description application, Please try to load application first and only afterwards load the settings" This message is displayed if Virus Protect program was "Virus Protect Fail – Press to Confirm" selected, but failed before Stabilize0 stage completed This message is displayed in pulse exhaust if exhaust valve "Exhaust Rate Error"...
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Message Description When float digital input of wastewater tank is true, display "Waste reservoir is full please empty the the message - "Drain waste reservoir" (Waste Water Tank reservoir " (Waste Water Tank is full) is full) This message is displayed when performing vacuum test, if "Leak"...
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Message Description •Will appear 2 weeks before expiration date (for one day) N = 14 •Will appear 1 week before expiration date (for one day) N = POP UP: "Please replace your front filter to preserve sterility in the chamber" Will appear when date expired and appears every month after the expiration date, until reset is performed Notification 2:...
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Message Description (Default: 10Sec, Permission: Factory). If parameter = 0, feature is disabled If parameter >0, Monitor Temperature AI (digital) is within the time frame of “AI monitor time frame” If AI reading is not changed during the time frame, block all outputs If the issue occurs during standby, prevent the cycle from starting and show the error “Analog Input Freezed - [AI_...
Safety instructions. Setting printer definitions. 11.1 General printer information The printer(s) are optional and can be purchased/ordered from Tuttnauer by the customer. The printer can easily be installed and connected to the autoclave following the instructions below. The options includes: One printer connected to the autoclave, loaded either with thermal paper roll, or with label roll.
11.2 Safety instructions Read all the instructions and keep them for future use. Follow all warnings and instructions on the product. 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. The mains socket shall be installed near the equipment and easily accessible.
11.3 Setting printer definitions To enable setting the printer, the user is required to log-in. 1. Press to display the Quick options screen. 2. Press to display the Login screen. 3. Enter the following information: Name - Admin Password - 0001 FactoryCode - IUE0ITADS2 4.
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5. Press to display the Settings screen. 6. Browse to System parameters/ Label printer type or Printer Type. 7. Select for paper roll - Printer Type 6. 8. Select for label roll - Label printer type 1. 9. If only one printer is connected to the autoclave, local = 0 or printer = 1. The table below, displays the various printer possibilities: Printer Type Local...
12. System Clean Program 12.1 General The System Clean program is a cleaning and descaling process for the family of Tuttnauer's T-Edge VET- 11 Autoclaves. It uses one tablet from the package - Cat#: SYSTEM CLEAN The tablet is composed from chemicals that are specifically designed for cleansing and removal of water deposit oxides and other sediments that exist in the piping, and in the Chamber of steam sterilizers.
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6. Select the System Clean program. 7. Close the autoclave door. 8. Remove the water tank cover and place one tablet (1) from the tablet packing (2) in the clean water reservoir (see below). Page 77...
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9. System Clean - Start cycle. Press 10. The System Clean process lasts approx. 30 minutes. Page 78...
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11. After approx. 30 minutes, the System Clean process is complete and the following screen is displayed. Press .The screen below is displayed. 12. Empty the clean water reservoir (see sec. 8.12). 13. Allow the chamber to cool completely before wiping clean. Note: Run an Unwrapped Instrument cycle, to remove residual chemicals from the piping.
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