Tuttnauer T-Top 10 Operation And Maintenance Manual
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Tuttnauer T-Top 10 Operation And Maintenance Manual

Table top steam sterilizer
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Operation and Maintenance Manual
Table Top Steam Sterilizer
Models T-Top 10
Cat. No. MAN205-0502033EN Rev. E
Tuttnauer Europe b.v.Hoeksteen 11, 4815 PR Breda,
P.O. Box 7191, 4800 GD Breda, Netherlands)Tel: +31/76-5423510, Ê Fax: +31/76-5423540

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  • Page 1 Operation and Maintenance Manual Table Top Steam Sterilizer Models T-Top 10 Cat. No. MAN205-0502033EN Rev. E Tuttnauer Europe b.v.Hoeksteen 11, 4815 PR Breda, P.O. Box 7191, 4800 GD Breda, Netherlands)Tel: +31/76-5423510, Ê Fax: +31/76-5423540...
  • Page 2 Operation and Maintenance Manual Table Top Steam Sterilizer Models T-Top 10 Cat. No. MAN205-0502033EN Rev. E June 2023 Tuttnauer Europe b.v.Hoeksteen 11, 4815 PR Breda, P.O. Box 7191, 4800 GD Breda, Netherlands)Tel: +31/76-5423510, Ê Fax: +31/76-5423540...

  • Page 3: Table Of Contents

    Table of Contents Paragraph Page No. 1. GENERAL INFORMATION 1.1 Manufacturer and Authorized Representative 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 / Intended Purpose 1.6 Intended Users 1.7 Warranty Description 1.8 Warranty Statement...
  • Page 4 6.2 Filling Water 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 7. CONTROL PANEL 7.1 Home screen Description and Functions 7.2 Opening the Device Door 7.3 Starting a Cycle 7.4 Available Sterilization and Test Programs 7.5 Cycle Succeeded / Cycle Failed Notifications and Follow-on 7.6 Aborting a cycle...

  • Page 5: General Information

    Box 7191, 4800 GD Breda, Netherlands. ) Tel: +31/76-5423510, Ê Fax: +31/76-5423540 1.2 Applicable Regulation and Quality Standards The life cycle of Tuttnauer's T-Top 10 is in compliance with the following regulation and quality standards: Regulation (EU) 2017/745 (MDR) EN ISO 13485 Quality Management System –...

  • Page 6: Legend For Symbols Appearing On The Labels And In This Manual

    1.3 Legend for Symbols appearing on the Labels and in this Manual Manufacturer Year of Manufacturing European Authorized Representative Medical Device Model Number Serial Number Consult the Operation and Maintenance Manual (User Manual) before use European compliance Mark of compliance with the European Medical Device Regulation (Number xxxx identifies the Notified Body that performed the examination) Keep away from sunlight and protect from heat.
  • Page 7 Keep dry 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 Page 3...

  • Page 8: General Description Of The Device

    USB device to be transferred to a PC. The device is Wi-Fi compatible, enabling remote tracking and monitoring by technicians and HQ services. Tuttnauer's R.PC.R software can be connected to the device via Wi-Fi or the Network Port. Page 4...

  • Page 9: Intended Use / Intended Purpose

    1.5 Intended Use / Intended Purpose The T-Top 10 tabletop autoclave is 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 & dental clinics) and laboratories.

  • Page 10: Warranty Statement

    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.

  • Page 11: Device Specifications

    1.10 Device Specifications 1.10.1 Device Overall Dimensions - T-Top 10 1.10.2 T-Top 10 fit into sterilization center cabinet - required 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 : Width - 482 mm;...
  • Page 12 1.10.3 Device Properties Property Dimension Width 462 mm Height 460 mm External size 585 mm supporting common install base carry a 605 mm counter Depth Diameter 249 mm Depth 450 mm Chamber Volume 23 lit Usable chamber 75% ( ~17 L) space Max.
  • Page 13 Property Dimension reservoir Safety relief valve 2.8 bar Load No. counter Counting from 0 to 500.00 and nullifies. 1.10.4 Device Electrical Data Property Value Total Power 1800W Voltage 1Ph / 230 VAC Amperage Protection against electrical IEC 61010-1 shock Mains supply fluctuation +/- 10% Frequency (Hz) 50Hz...

  • Page 14: Requirements With Concern To Water Quality

    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 this mandatory). The electrical network must comply with local rules and regulations. Verify that there is an easy access to the main power switch and to the current leakage safety relay (GFCI).
  • Page 15 Substance Feed Water Condensate Conductivity (at 20°C) ≤15 µs/cm ≤ 3 µs/cm pH value 5 to 7.5 5 to 7 Hardness ≤ 0.02 mmol/l ≤ 0.02 mmol/l Appearance Colorless, clean, without sediments Compliance with the above data should be tested in accordance with acknowledged analytical methods, by an authorized laboratory.

  • Page 16: Safety

    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.

  • Page 17: Safety Features Incorporated In The Device

    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.
  • Page 18 Ethernet and Wi-Fi connection Importing and exporting settings by the internet. Exporting settings by the local network. Installing new software versions from the internet. Exporting cycles data by the local network, or by the internet. Monitoring the devices from a local network or from the internet. Recommended instructions for cybersecurity controls: Use known source USB for exporting data.
  • Page 19 The user can monitor the machine and download cycles from the local network. 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.

  • Page 20: Depiction Of System Parts

    3. Depiction of System Parts 3.1 Front View 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) Door switch (lock)

  • Page 21: Top View

    3.2 Top View Description Water tank cover Water tank flip cover Mineral-free water reservoir opening Page 17...

  • Page 22: Rear View

    3.3 Rear View Description Description Safety valve Power socket Aeration ventilation opening USB port Fuses Used water drain outlet Warning! Mind the power socket. Keep it and its vicinity dry. Danger of electrocution. Page 18...

  • Page 23: Installation Instructions

    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.

  • Page 24: Connections To Utility Supplies

    4.3 Connections to Utility Supplies Check and verify that the power supply is a 1 phase, 230VAC ±10%, 50Hz. 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.

  • Page 25: Initial Operation Of The Device

    4.5 Initial Operation of 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.

  • Page 26: Before Starting The Autoclave

    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 45°C. To reset the Atmospheric Pressure manually: In the Quick Option screen, press the Settings icon , then browse to Maintenance/Reset atmospheric pressure.
  • Page 27 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.
  • Page 28 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: 4. Press on the to return to the Info screen.

  • Page 29: Pre-Sterilization Cleaning And Disinfection Of Instruments And Their Loading Into The Device

    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.
  • Page 30 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.

  • Page 31: Operating Instructions

    6. Operating Instructions Warnings! The autoclave is intended for indoor use only. Do not operate the autoclave in the presence of dangerous gases and vapors. If applicable: The Emergency Stop Push-Button in cooperative with key lock mounted on the front panel switches OFF the autoclave operation.

  • Page 32: Turning On The Device

    On closing the autoclave door, make sure that it is properly locked before starting a cycle. Don’t place your hand or head, etc. above/beside/below or close to the door while opening it as hot steam is escaping the chamber. Do not stand near the back panel of the autoclave while the device is operating as the pressure safety valve may release steam.
  • Page 33 The following screen shows that the Waste water tank is full. 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 29...

  • Page 34: Filling Water In The Reservoir

    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.

  • Page 35: Setting Date And Time

    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.

  • Page 36: Control Panel

    7. 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 32...
  • Page 37 Page 33...

  • Page 38: Home Screen Description And Functions

    7.1 Home screen Description and Functions Icon Name Description Home icon Main screen selection icon Menu Menu selection icon Unwrapped 134 Unwrapped Instruments 134°C 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...
  • Page 39 Icon Name Description Warnings Indicates the Alerts Unwrapped 121 Unwrapped 121°C load program Side arrow left Paging backward to the previous programs Bowie Dick / Helix Periodic testing as referred to in ISO 17665-1 Vacuum Test Test program System Clean program cleans the autoclave System Clean chamber and the water and steam piping Prion 134...

  • Page 40: Opening The Device Door

    For the Prion cycle, only the physical sterilization parameters were validated (i.e. sterilization holding time, sterilization temperature) as the national regulations require this validation only. There is no regulatory requirement to validate the sterilization effect on the Prion protein such as elimination or deactivation. In accordance with the regulations, the sterilization temperature is 134°C and the sterilization holding time is 18 minutes.

  • Page 41: Starting A Cycle

    7.3 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 5). Choose the appropriate sterilization program.
  • Page 42 The next screen will prompt the selected program information. Close the door by both: Pushing the door gently; Pulling the handle 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 7.
  • Page 43 Screen display while "Unwrapped 134" sterilization program is in progress. Note: For the results of the cycle, see description in section 7.4 Page 39...

  • Page 44: Available Sterilization And Test Programs

    7.4 Available Sterilization and Test Programs Notes: 1. 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. 2.
  • Page 45 7.4.2 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. Heating stage: steam is inserted into the chamber until the sterilization temperature is reached. Sterilization: sterilization temperature is maintained constant during the sterilization time.

  • Page 46: Cycle Succeeded / Cycle Failed Notifications And Follow-On

    7.5 Cycle Succeeded / Cycle Failed Notifications and Follow-on 7.5.1 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". 7.5.2 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"...

  • Page 47: Aborting A Cycle

    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. 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.

  • Page 48: Custom Programs

    Custom programs require validation by the user! Validation of the sterilized cycle is the user's responsibility. T-Top 10 offers the user a customized program, adjusted in order to sterilize items that cannot be sterilized in any of the preceding default programs.

  • Page 49: Cycles History

    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.

  • Page 50: Opening The Door And Unloading

    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.

  • Page 51: Draining The Reservoirs

    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).
  • Page 52 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.

  • Page 53: Preventive And Scheduled Maintenance To Be Performed By The Operator

    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 Europe . 8.1 Daily Maintenance Caution! Make sure the autoclave is not hot before cleaning it.

  • Page 54: Monthly Maintenance

    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.
  • Page 55 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.
  • Page 56 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 ).
  • Page 57 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.

  • Page 58: Full List Of Informative Screen Display Symbols, Operating Messages, Error Messages And Troubleshooting

    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.

  • Page 59: Error Messages & Troubleshooting

    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.
  • Page 60 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"...
  • Page 61 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”...
  • Page 62 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 >...
  • Page 63 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.
  • Page 64 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.
  • Page 65 Message Description 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_ NAME]” If the issue occurs during the cycle, stop the cycle and show the error “Analog Input Freezed - [AI_NAME]”...

  • Page 66: Tsc Printer Installation (Optional)

    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.
  • Page 67 Page 63...

  • Page 68: Safety Instructions

    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.

  • Page 69: Setting Printer Definitions

    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.
  • Page 70 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...

  • Page 71: System Clean Program

    11. System Clean Program 11.1 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#: SYSTEM CLEAN 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.

  • Page 72: System Clean Cleaning Procedure

    11.2 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.
  • Page 73 9. System Clean - Start cycle. Press 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. Page 69...
  • Page 74 12. Upon cycle completion, follow the instructions below: Open the autoclave door to enable the chamber to cool Remove the water tank top cover Empty both clean water and waste water reservoirs Wipe the walls, bottom and the electrode of the clean water reservoir Wipe the walls and bottom of the waste water reservoir When the chamber cools completely, wipe the walls of the chamber Note: The electrode in the clean water reservoir detects water;...
  • Page 75 15. Turn off the power and enable the chamber to cool completely. 16. Place the tray holder and trays back in the chamber. Page 71...
  • Page 76 Cat. No. MAN205-0502033EN Rev. E COPYRIGHT ©...

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