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 Indications for Use 1.6 Intended Users 1.7 Warranty Description...
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6.3 Filling water in the reservoir 6.4 See the requirements concerning Water Quality, in Section 1.11 6.5 Setting Date and Time 6.6 Class S 7. OPERATING INSTRUCTIONS - CONTROL PANEL 7.1 Home screen Description and Functions 7.2 Opening the Device Door 7.3 Starting a Cycle 7.4 Available Sterilization Programs and Test Programs 7.5 Cycle Succeeded / Cycle Failed Notifications and Follow-on...
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12. SYSTEM CLEAN PROGRAM 12.1 General 12.2 System Clean Cleaning Procedure Page III...
1. General Information 1.1 Manufacturer and US Official Correspondence Information T-Top autoclaves are manufactured by Tuttnauer Ltd., Located Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel. )Tel: +972-2-9904611 The US Official Correspondence is the following: + Tuttnauer U.S.A.
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EN 61326- 1 - EMC Requirements for Electrical Equipment. The autoclave defines Class A - devices, are those that are marketed for use in a commercial, industrial, or business environment. IEC 62304 - Medical Device Software – Software life cycle processes Page 2...
1.3 Legend for Symbols appearing on the Labels and in this Manual Manufacturer Year of Manufacturing Medical Device 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...
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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 Page 4...
1.4 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 a clear documentation of the sterilization cycle. Drying is performed with the door closed). This autoclave uses steam as a sterilizing agent.
Indications for Use The T-Top 10 and T-Top 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in healthcare facilities (e.g. hospitals, nursing homes, extended care facilities, freestanding surgical centers, clinics and medical &...
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.
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1.10.2 Device Overall Dimensions - T-Top 11 1.10.3 T-Top fit into sterilization center cabinet - dimensions: To allow adequate cooling & ventilation of the autoclave placed inside the sterilization center Cabinet, the following are the minimum dimensions required for the cabinet : T-Top 10: Width - 19"/482 mm;...
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Dimension Property T-Top 10 T-Top 11 Used (waste) ~127 Ounces (3.75 lit) - up to float water Max. water volume ~182.5 Ounces (5.4lit.) - overflow reservoir Safety relief valve ~40 PSI (2.8 bar) Load No. counter Counting from 0 to 500.00 and nullifies.
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1.10.6 Utility Requirements Value Property 230V 120V Mineral-free water See table in Water Quality Drain Optional - 10mm, withstanding temp. of 80°C * 1 phase, 230VAC ±10%, * 1 phase, 120VAC ±10%, Power supply 50/60Hz 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...
1.11 Requirements with concern to Water Quality Warnings: The use of water for autoclaves that do not comply with the table below may have severe impact on the working life of the sterilizer and can invalidate the manufacturer’s warranty. In the case of a generator: Use only water having the characteristics stated in the table below.
Notify the person in charge immediately of any deviation or risk of proper function of the device or with the shipping carrier, and also notify the Tuttnauer representative. Insufficient space for ventilation may result in malfunction or damage due to overheating.
In order to assure proper operation of the autoclave, it should not be placed in the vicinity of electrical equipment which is not certified for Electromagnetic Compatibility according to IEC/EN 61326-1. The user shall report any serious incident that occurred in relation to the sterilizer, to the manufacturer and the authority having jurisdiction in their locale.
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Software updating requires authentication. Update the autoclave software to the latest version as recommended by the manufacturer. Note: The autoclave software is stand-alone and does not require connecting to the internet. Protective features The autoclave control system includes the autoclave main application and a dedicated agent for cybersecurity and IoT (remote connection capabilities).
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Network Diagram Instructions for users on how to respond upon detection of a cybersecurity vulnerability or incident If you detect a cybersecurity vulnerability or incident, it is important to take immediate action to minimize the impact and prevent further damage. Here are some steps to follow: Disconnect the affected device or system from the network.
3. Depiction of System Parts 3.1 Front View T-Top 10" Description Description Door switch (close) Chamber ON/OFF switch (beneath the service Door gasket panel) Clean water drain (beneath the service Air filter panel) USB port (beneath the service panel) Touch screen Used water drain (beneath the service Door handle panel)
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T-Top 11" Description Description Door switch (close) Chamber ON/OFF switch (beneath the service Door gasket panel) Clean water drain (beneath the service Air filter panel) USB port (beneath the service panel) Touch screen Used water drain (beneath the service Door handle...
3.3 Rear View Description Description Safety valve Power socket Aeration ventilation opening USB port Fuses Overflow drain outlet Warning! Mind the power socket. Keep it and its vicinity dry. Danger of electrocution. Page 21...
4. Installation Instructions 4.1 Lifting and Carrying Warnings! Only technical personnel having proper qualifications and holding technical documentation (including a Technician Manual), and adequate information are authorized to install and serve the apparatus. Before moving the autoclave, make sure that the electric cord is disconnected from the power, and there is no pressure in the chamber.
4.3 Connections to Utility Supplies Check and verify that the power supply is as follows: 230V - 1 phase, 230VAC ±10%, 50/60Hz. 120V - 1 phase, 120VAC ±10%, 60Hz. Check and verify that the electrical net is protected by a current leakage safety relay. The autoclave is defined as a Class A device, marketed for use in a commercial, industrial, or business environment.
4.5 Configuring the Device Note: Remove all external 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 ON/ OFF Switch mounted on the front panel, behind the control door. When you turn on the autoclave, it will automatically warm up.
4.6 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 Printer Configuration Select the printer type from the Machine Configuration screen, and press Checking the device Version information. 1. In the Quick Option screen, press the Info option 2. Select the Version information. Page 27...
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4. Press on the to return to the Info screen. Page 28...
Check the instructions of the item manufacturer as to the proper procedure for cleaning, disinfecting and sterilizing each item. It is recommended that instruments be ultrasonically cleaned using Tuttnauer’s Clean & Simple enzymatic cleaning tablets or other suitable solution. 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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Tilt on edge items prone to entrap air and moisture, e.g. hollowware, so that only minimal resistance to air removal exist, the passage of steam and condensate will be met. Wrapped instruments should be placed in material which will allow steam penetration and promote drying, such as autoclave bag, autoclave paper, or muslin towels.
6. Initial Operating Instructions 6.1 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 ON/ OFF Switch mounted on the front panel, behind the control door. 6.2 Filling Water Cautions! In the beginning of each day, check the water level in the reservoir.
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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. Page 32...
6.3 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 warranty. 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.
6.5 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.
6.6 Class S Class S: General description Class S used in the USA obtain weaker vacuum level and is less effective than Class B in the sterilization of hollow instruments. The following tables provide: Table A provides the types of sterilization cycles. Table C provides the T-Top, Class S sterilization programs.
7. Operating Instructions - 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. 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 36...
7.1 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 Proper water level Sufficient Water in the clean reservoir...
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Icon Name Description Warnings Indicates the Alerts Handpieces 270F Handpieces 269.6°F load program Side arrow left Paging backward to the previous programs Wrapped Pouches Wrapped Pouches 270F partial load program 270F/2kg Duplicates a sterilization program and enables modifying the settings. Custom Note: This is not an FDA approved program! Bowie Dick Helix...
7.2 Opening the Device Door Warnings! During loading and unloading use safety gloves and glasses in accordance with local safety regulations and good practice. If applicable: Do not remove the top cover during a running cycle. Hot water / steam may exit! This machine is equipped with an electronic door lock.
7.3 Starting a Cycle It is recommended to perform B&D test cycle at the beginning of each working day. Note: Run the cycle with the tray holder and trays in the chamber. Before each cycle, check visually that the gasket is intact, not loose and clean. Load the autoclave properly (see chapter 5).
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When the door is closed, the open-door symbol is replaced with the closed-door symbol , and the door-lock symbol will not appear until initiating a cycle. 7. Press the button to start the cycle. For cycle process description, see Sterilization Cycle Description. Warning! Do not remove the top cover during a running cycle.
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Note: For the results of the cycle, see description in section 7.4 Page 43...
Do not overload! Exceeding the maximum load weight (see Class S tables below), may result in moist instruments, consequently leading the user to increase the dry time. Class S Maximum load weight Load type Suitable for programs T-Top 10 T-Top 11 Handpieces 5 units Handpieces Solid Unwrapped ~13 lbs ( 6.0kg) ~19.8 lbs ( 9.0kg)
Drying: performed with the door closed by pulling vacuum and using the accumulated heat in the chamber and the load to remove leftover moisture from the instruments and wraps. 7.4.3 Description of the Vacuum Test Stages Vacuum is produced in the chamber, down to P1=2.17 psi (15 kPa.) At this stage all the valves close. The autoclave remains in this stage for 5 minutes.
Warning! The load has not completed a sterilization cycle; therefore, it is not sterile. Handle it as a contaminated load. Any failure means that the load is not sterile. 7.6 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.
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Press the button to confirm the displayed message. Warning! The load has not completed the cycle; therefore, it is not sterile. Handle it as a contaminated load. Page 47...
7.7 Custom Programs Custom programs are not FDA approved! Validation of the sterilized cycle is the user's responsibility. T-Top offers the user a customized program, adjusted in order to sterilize items that cannot be sterilized in any of the preceding default programs. To utilize a customized program: Have your dealer or service technician create a customized program.
3. Press to begin the customized cycle. 7.8 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.
7.9 Opening the door and Unloading Press to confirm the "Successful" or the "error" message to unlock the door. Open the door. Use the tray handle or wear heat-resistant gloves to remove the load from the autoclave. After unloading, visually inspect the load to ascertain that it is dry, and that sterilization indicators have made the required color change.
7.11 Draining the Reservoirs Warnings! Never reuse waste water. 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! This procedure applies to the mineral-free water reservoir (left) and to the waste-water reservoir (on the right).
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Put the other end of the hose into a drain bucket. Open the valve by turning it counterclockwise. When the water reservoir is empty, close the valve by turning it clockwise and remove the hose. Return the socket cap. Caution! Never reuse waste water. If the drained reservoir is the clean-water reservoir, fill the reservoir with distilled water until it reaches the full level.
7.12 Adjusting the door Warnings! Do not adjust until the sealing cover cools down. Ensure the sealing cover is not too loose as it may cause steam leakage while sterilization. To adjust the door: The tie rod is situated within the door cover, visible at the lower part of the door cover. Gently pull down the tie rod while concurrently making a slight turn to the sealing cover.
The maintenance operations described in this chapter need to be followed as indicated to keep the device in good working condition and to keep any breakdown time to a minimum. Should the need arise, technical assistance or a service technician can be requested by either calling your dealer or Tuttnauer U.S.A . 8.1 Daily Maintenance Caution! Make sure the autoclave is not hot before cleaning it.
8.3 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. Clean the outer parts of the autoclave with a soft cloth.
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The AIR filter is located, when opening the door, in the upper left corner . Pull out the filter. Connect 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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Open the autoclave chamber door and remove the tray . Clean with a soft cloth the filter and the area around the filter. Check that the autoclave functions normally after the drain filter cleaning. Note: If by cleaning the filter the result is not satisfactory, proceed to the replacement of the drain filter. (paragraph 8.4.3 ).
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The drain filter is located inside the autoclave chamber at the bottom far end. To reach the filter, open the chamber door and remove the tray holder. Open the autoclave chamber door and remove the tray. Unscrew the old Drain filter assembly (screw + net). Screw the new Drain filter assembly, (screw + net) to its place in the chamber bottom, tighten it manually.
9. 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 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 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" Gap parameter during the sterilization cycle (stabilize stage) This message is displayed if the temperature rises above "Chamber high temperature error"...
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Message Description 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) "Pressure time error”...
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Message Description 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" = ON and pressure delta every 60sec > Parameter Exhaust rate (System parameter) This message is displayed if, JHT >...
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Message Description This message is displayed when performing vacuum test, if "Leak" after 5 and 10 minutes the pressure is above the Max Pressure Gap parameter This message is displayed if the user decides to start cycle "Start cycle by clock is active" by clock.
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Message Description 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: "It is highly recommended to replace the front filter"- •Will appear when date expired and appears every week until reset is performed.
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Message Description Disk space utilization should be monitored every 12 hours or on start up (writing logs). "Low disk space error" If the disk space is used up by more than 75%: Send telemetry Show notification to user in Active alarms This message is displayed when the door is not open when "Door is not open"...
Safety instructions. Setting printer definitions. 10.1 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.
10.2 Safety instructions Warnings! Hazardous moving parts, keep fingers and body parts away. For an external printer: The print head may be hot and could cause severe burns. Allow the print head to cool. Due to the high temperature exuding from the autoclave’s upper water tank, please refrain from locating the printer or other equipment on the top cover of the device.
10.3 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...
11. Built-in Printer (optional) 11.1 Depiction of Printer Parts Description Description LF button / indicator light Paper roll Lock Fastener Paper case cover Paper roller Page 72...
11.2 General Printer Information 11.2.1 Printer Output: The autoclave is equipped with a character printer, which prints a detailed history of each cycle performed. (This can be used for the record or for subsequent consideration.) The printing is on thermal paper with a defined set of characters per line and contains important information such as some of the main following details: Date:, Time: , Ser.
11.3 Replacing the Paper Roll 1. Extract the rotated wrench from the location indicated by the arrow in Fig. 1 and rotate it until the paper cover opens, as illustrated in Fig. 2. 2. Uncover the paper, insert it into the printer, and pull out a small section, taking note of the paper direction as depicted in Fig.
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12. System Clean Program 12.1 General The System Clean program is a cleaning and descaling process for Tuttnauer's T-Top Autoclaves. It uses one tablet from the package - Cat#: CLE096-0075 - T-System Clean Box with 12 tablets. The T-System Clean 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 Chamber of steam sterilizers.
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12.2 System Clean Cleaning Procedure The System Clean cleaning program for the family of Tuttnauer's T-Top Autoclaves is described below: Important : To avoid burns when removing the trays and holders, the chamber must be cold. Use gloves to protect your hands from the chemicals.
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8. Close the autoclave door. 9. System Clean - Start cycle. Press Page 78...
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10. The cycle cleans the piping and the chamber. The System Clean process lasts approx. 25 minutes. 11. After approx. 25 minutes, the System Clean process is complete and the following screen is displayed. 12. Upon cycle completion, follow the instructions below: Open the autoclave door to enable the chamber to cool Empty both clean water and waste water reservoirs It is recommended to remove the water tank top cover and wipe the walls, bottom and the electrode...
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Note: The electrode in the clean water reservoir detects water; therefore, if the reservoir is not emptied, a notification will reappear on the screen. 14. Press Confirm. 15. Return the tray holder and trays to the chamber, being cautious as the inner chamber wall may be hot! 16.
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Where is the exhaust valve located on the TTop 11 autoclave