Raypa TLV-50(DUAL) Instruction Manual For Use And Maintenance

Autoclaves for sterilization
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TLVi/15
INSTRUCTION MANUAL
FOR USE AND MAINTENANCE
AUTOCLAVES FOR STERILIZATION
Models:
TLV-50(DUAL) / TLV-75(DUAL) / TLV-110(DUAL) / TLV-150(DUAL)
TLV-50FA / TLV-75FA / TLV-110FA / TLV-150FA
TLV-50PD / TLV-75PD / TLV-110PD / TLV-150PD
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Summary of Contents for Raypa TLV-50(DUAL)

  • Page 1 TLVi/15 INSTRUCTION MANUAL FOR USE AND MAINTENANCE AUTOCLAVES FOR STERILIZATION Models: TLV-50(DUAL) / TLV-75(DUAL) / TLV-110(DUAL) / TLV-150(DUAL) TLV-50FA / TLV-75FA / TLV-110FA / TLV-150FA TLV-50PD / TLV-75PD / TLV-110PD / TLV-150PD 1/64...
  • Page 2: Table Of Contents

    TLVi/15 This manual has been written for safety reasons. Read the instructions carefully before installation and use of this apparatus. If this apparatus should be sold or transferred ensure that this manual is given to the new owner, for correct use and installation. Keep this manual in a known place near the instrument to have it available in the case of doubt or for maintenance reasons This symbol indicates that, in accordance with applicable regulations, the product must not be...
  • Page 3: Packing List And Accessories

    TLVi/15 1 PACKING LIST AND ACCESSORIES 1.1 Included elements  1 steam sterilizer  4 pressure hoses  1 instruction manual 1.2 Optional accessories  Built in printer This accessory must be installed at our facilities. It uses thermal paper of Ø50x57mm Ref.
  • Page 4 TLVi/15  Flexible “Heart” probe PT-100 Recommended for sterilizing liquids in flasks of 1 L or bigger. The control is done from the microprocessor. This accessory should be installed in factory. Ref. PT-2-TLV  Bowie & Dick test Checks the absence of residual air. Box with 30 samples.
  • Page 5: Safety

    TLVi/15 2 SAFETY This sterilizer has been built in accordance to current technology and respecting the safety regulations. In spite of this, the device can cause damages:  If it is used to unforeseen.  If it is manipulated by unskilled people or without the adequate training. 2.1 Symbols They identify dangerous situations and precautions that have to be taken.
  • Page 6: Modifications

    TLVi/15 For any damages caused by this kind of uses, the unique responsible will be the user. The following uses are specially considered as improper:  The use of this device in locals or dependences requiring anti- deflagration devices.  The use of this device to sterilize hermetic containers. (only “TLV”, “PD”...
  • Page 7: Description Of The Equipment

    TLVi/15 3 DESCRIPTION OF THE EQUIPMENT PC Panel Lid thermal protection Pushbutton for OPEN-CLOSE the lid Main switch 4 INSTALLATION  After unpacking the equipment, visually check that all components are in good condition. *NOTE: Remove the blue protective foam from the cover. It is important to detect possible transport damage at the time of unpacking in order to be able to complain to the carrier, distributor, etc.
  • Page 8 TLVi/15 It is very important to properly fix the connection 6 to a drain. During operation, there is pressure and temperature inside this hose producing vibrations that in case of not being fixed the hose could be released from the drain and burns could be produced.
  • Page 9 TLVi/15 C. TANK-TLV (optional accessory) External tank to feed the TLV/TLV-FA/TLV-DUAL equipment. It has an acoustic signal that is activated when the level of the tank is minimum. Use the funnel to fill the tank with purified water. Connect the tank hose to the sterilisation water inlet (14).
  • Page 10 TLVi/15 D. TANK-TLV-PD (opcional accesory) External tank to feed the equipment TLV-PD & TLV-DUAL. It has an acoustic signal that is activated when the tank level is at its lowest. Pressure pump. TANK TLV-PD Connect the pressure pump to the inlet (14), connect the sterilisation water outlet to the PD tank (5) and finally connect the canister outlet to the pump inlet.
  • Page 11: Connection To The Mains

    TLVi/15 Main switch: In the ON position the water level sensor will be activated. When the water level reaches the minimum it will beep. To deactivate the beep, press the switch to the OFF position, refill the tank and turn on the device. 4.2 Connection to the mains A characteristics plate situated in the rear of the equipment shows voltage, power, etc.
  • Page 12 TLVi/15 TLV connections: TLV-FA connections: TLV-PD connections: TLV-DUAL connections: 12/64...
  • Page 13: Controller/Programmer Description

    TLVi/15 5 CONTROLLER/PROGRAMMER DESCRIPTION 5.1 Login After turning on the device, the login menu will appear. To create a new user account, click on the add user button located on the upper right side of the screen. 3 options are displayed: 1- Create local account without connection to RAYPAcloud server (left).
  • Page 14 Enter the password twice and confirm with the "Registration" button. When Raypa validates the account, the user will receive an email indicating that the account is already in operation. To access the account choose the email address from the list and enter the password.
  • Page 15: Raypacloud Software

    TLVi/15 5.1.1 RAYPAcloud software RAYPAcloud is a web software for managing Raypa autoclaves. You can connect to RAYPAcloud at https://www.raypacloud.com with a PC, Smartphone, Tablet, etc. Register a user account Real-time view of directly from the autoclave, Email notification autoclave data through the or on the web at management.
  • Page 16 Register Page 3- After pressing the REGISTER button, an email will automatically be sent to Raypa. The user will see a notification on the screen. 4- When Raypa validates the account, the user will receive an email confirming that the account is activated and is already in operation.
  • Page 17 TLVi/15 Protocol template View of the different equipment options By clicking on the image button, it will show the different options available in the selected equipment: Protocols / Programs / Backups / Audit Trails / Notifications By clicking on the button will show the entire operation log.
  • Page 18: Connection To The Local Private Cloud Server

    TLVi/15 5.1.2 Connection to the local private cloud server (A private cloud server is required) 1- Connect an Ethernet cable from the private cloud server to a router. 2- Browse Settings  Network  Choose server 3- Choose the option “Add a server from a local network” 4- The system will search for the server.
  • Page 19: Raypatrace

    TLVi/15 5.2.2 RAYPAtrace RAYPAtrace is a tool that allows you to provide a complete and traceable documentation for sterilization processes in a simple and professional way. 1. If RAYPAtrace is activated (Settings  Sterilization  RAYPAtrace documentation upload), the wizard will be displayed when the program starts. NOTE: Use with barcode scanner and label printer.
  • Page 20: Monitor

    5.3 Information Menu In the information tab you can contact Raypa technical support directly from the touchscreen screen. It is also possible to view the step-by-step videos.
  • Page 21: Remote Support With Teamviewer

    "Support" button on the "Information" tab and on the next screen select the "Share screen with RAYPAsupport" option. This option can only be made if a specific time has been previously agreed with Raypa to make the connection. This can be done via phone, email, or directly from the computer, by sending an email to RAYPAsupport.
  • Page 22: Print Protocols

    TLVi/15 5.4.2 Print protocols 1- Search for the "Logging" tab. 2- Search for the protocol in the list shown on the left side of the screen. 3- Click on the protocol to have a detailed view to the right of the screen. 4- Press the print button located in the upper right side of the screen to open the print window.
  • Page 23: Printing Template

    TLVi/15 5.4.3 Printing template Settings  Sterilization  Print data points ON/OFF Ticket format for TLV and TLV-FA Ticket format for TLV-PD / TLV-DUAL St: Stage SW: Pre-heating SF11: 1 Pre-vacuum SF12: 1 vacuum pulse SF21: 2 vacuum pulse SF22: 2 pressure pulse SF31: 3 vacuum pulse...
  • Page 24: Print Traceability Label

    TLVi/15 5.4.4 Print traceability label 1- Search for the "Logging" tab. 2- Search for the protocol in the list shown on the left side of the screen. 3- Click on the protocol to have a detailed view to the right side of the screen. 4- Press the print button located in the upper right side of the screen to open the print window.
  • Page 25: Batch Control

    TLVi/15 5.4.6 Batch control When using biological indicators, you can have a cycle control by activating the Batch control option (SettingsSterilizationBatch control). Once the cycle is finished, go to the “Logging” tab and when selecting the cycle you can indicate whether the result of the indicator is correct or not. There is also the option to input the result later.
  • Page 26: Lan Connection

    TLVi/15 WiFi network connection 1- Enable the WLAN ON/OFF option 2- Press Manage WLAN connections to see the list of available networks. Press on the desired network to enter the required data and password. This network will be stored in the device memory and will connect to it by default.
  • Page 27: Language Settings

    TLVi/15 Select an option: The autoclave will search for the Private Server in the local area network. After finding it confirm by pressing the "Save" button If the autoclave is connected to the internet, the RAYPAcloud can be used instead of the private Server.
  • Page 28: System Settings

    Check for updates This option should only be selected after consultation with the Raypa SAT. In some cases it may be more convenient NOT to update it, especially if the software is validated. 1- The autoclave must be connected to the internet.
  • Page 29 If an internet connection is not available, updates can be installed with a USB stick. You can request the “update.zip” file from Raypa and copy it to the USB memory stick. Use the back port of the device lid to connect the USB stick and activate this option to download and install updates.
  • Page 30: Audit Logs (Only Visible With Fda-Enabled Mode)

    USB stick and if you have a RAYPAcloud account, the option to export a copy of the database to the cloud will also be available. Raypa admin enabled Option only for inquiries to Raypa SAT. Display UART Logs It displays the communication between PC Panel and the board.
  • Page 31: Sterilization Settings

    TLVi/15 Press the "Save" button to apply the changes. 5.5.8 Sterilization settings Step-by-step guide Enables/disables the step-by-step guide. Export protocols to a USB stick Place a USB stick in the port located on the back of the device to export the protocols. NOTE: Some USB sticks may not be written immediately.
  • Page 32 TLVi/15 Export all protocols to RAYPAcloud Once registered with RAYPAcloud account, backup copy will automatically be made to RAYPAcloud online storage. This action can be verified if a “check” appears in the cloud of each of the protocols. Label designer If no barcode label is available, the user can use the label designer tool.
  • Page 33: Calibration

    TLVi/15 5.5.9 Calibration It allows to edit temperature and pressure probe offsets. This section should only be handled by specialized personnel. 5.5.10 Lockout (only in Administrator mode) This option will only be available in administrator mode. Parameters that the administrator can block to the user accounts. Only editable for the "Admin" account and accounts with administrator privileges.
  • Page 34: Logout

    TLVi/15 5.6 Logout To end the session press the icon on the upper left side of the screen. 5.7 Create a new program (only in Administrator mode) Press the icon located at the top of the screen. Fill in the values on the next screen and click on the "save"...
  • Page 35: Preset Programs

    TLVi/15 5.8 Preset programs “TLV-PD” & “TLV-DUAL” Models Program Name Vacuum Temperature Time Drying SOL/LIQ Probe SOLID VACUUM SOLID Porous-134 SOLID Prion-134 SOLID Porous-121 SOLID Hollow-134 SOLID Hollow-121 SOLID Wrapped-134 SOLID Wrapped-121 SOLID Solids-134 SOLID Solids-121 SOLID Flash-134 SOLID Liquid LIQUID Liquid Probe LIQUID...
  • Page 36: List Of Errors And Alarms

    TLVi/15 5.9 List of errors and alarms Errors If an error occurs during sterilization, the device will display a visual and acoustic alarm. If configured, a notification will also be sent by email. The device will perform the necessary operations to discharge the pressure of the device and stop the heating automatically.
  • Page 37 TLVi/15 Check water supply, the tap must be Water does not reach the steam open. Verify that water is pumped into NO WATER generator during the process. the autoclave with the necessary pressure. Reset it manually once it is cold. If the RESET SAFETY The safety thermostat has tripped.
  • Page 38: Load Distribution

    TLVi/15 Vacuum is not reached to properly Check the vacuum pump or any ERROR CLOSE DOOR 1 close the door. possible leakage in the vacuum lines. Sensor 2 is failing or some sensor One of the previous component is ERROR CLOSE DOOR 2 from the lid is failing or closing ring failing or not properly adjusted.
  • Page 39 TLVi/15 Always avoid touching the material directly with your hands Protect the hands from sharp and/or cutting objects Wash your hands thoroughly, even if gloved, once you have finished handling the material to be sterilized Then proceed to carefully clean the material to be sterilized by eliminating all types of residues.
  • Page 40: Start Up

    TLVi/15 ENVELOPED MATERIAL (“PD” & “DUAL” models only) Envelope instruments separately, or, in case of placing several instruments in the same package, verify that they are made of the same material. Seal the envelopes with adhesive tape for autoclave or with heat sealer. Never use metal clips, pins or other similar items.
  • Page 41 TLVi/15 *Note: keep in mind that distilled water that is too pure (conductivity of lower than 5 µS/cm) is not advisable as it can cause corrosion in stainless steel and water level detection problems in some models. Water quality (cooling) Preferably use decalcified water to avoid clogging of pipes Introduce the material to be sterilized inside the autoclave, so that there are spaces between the material for the steam to circulate.
  • Page 42 TLVi/15 ■ Preheating ■ 1 Pulse Vacuum ■ 2 Pulse Vacuum (“PD”& “DUAL”) ■ 3 Pulse Vacuum (“PD” & “DUAL”) ■ Stabilization ■ Sterilization ■ Unloading ■ Drying (“PD” & “DUAL”) ■ Ventilation ■ Levelling ■ END OF PROCESS At the end of the sterilization cycle (END OF PROCESS) an acoustic warning sounds. If during the cycle, there has been an abnormal situation or the “STOP”...
  • Page 43 TLVi/15 The device will start to warm up and a timer (total counter) will appear indicating the time elapsed since the start. Next the PULSE VACUUM phases will be carried out, according to the number of programmed pulse vacuum phases. The last pressure pulse is the one that will reach the programmed sterilization temperature.
  • Page 44: Test Programs

    TLVi/15 Test programs (“PD” model only) The autoclave has automatic test programs for the verification of a correct sterilization process. The programs are: Vacuum Test Bowie Dick Test Vacuum Test To start the vacuum test, the temperature of the chamber wall probe must be below 30°C.
  • Page 45: Maintenance

    TLVi/15 Once the forced ventilation is finished, a warning beep will sound. Ventilation will be repeated at 8’. If the door is opened at any time, the "FORCED VENTILATION" process would terminate.  8 MAINTENANCE To ensure safe and efficient operation during the autoclave lifespan, it is necessary that the user, in addition to making proper use of it, regularly performs some maintenance operations.
  • Page 46 TLVi/15 Always keep in mind the following general warnings: - Do not subject the autoclave to washing by direct water jets, both under pressure and rain. Possible infiltrations in electrical and electronic components could affect, even hopelessly, the operation of the device or its internal parts. - Do not use abrasive cloths, metal brushes (or other aggressive materials) or products to clean both solid and liquid metals, to clean the autoclave or sterilization chamber.
  • Page 47 TLVi/15 8.2.4 Disinfection of external surfaces To perform sporadic disinfection of the external surfaces, use denatured alcohol. 8.2.5 Cleaning/replacing the discharge filter With use, residues of different types are likely to accumulate in the filter, clogging the lower discharge duct. To clean (or replace) the filter, unscrew the cap indicated in the drawing (it is advisable to place a container underneath to collect the liquid that the tank and the piping circuit may...
  • Page 48 TLVi/15 Periodically remove the bacterial load from the bacteriological filter by subjecting it to a sterilization program at 121ºC. At the end of the program, couple it back into its own support by tightening it thoroughly  THE STERILIZATION PROCESS DOES NOT ELIMINATE FILTER OBSTRUCTIONS, OR PROLONG IN ANY WAY ITS LIFESPAN.
  • Page 49 TLVi/15 8.2.9 Safety valve maintenance This operation is required to ensure the proper functioning of the valve in a long-lasting manner. Previous indications: Perform this operation with the cold autoclave (room temperature) and without pressure. Make sure that the autoclave is switched off and disconnected from the electrical network.
  • Page 50: Emptying The Steam Generator

    TLVi/15 As these controls require, in addition to specific expertise and preparation, the use of particular tools (high precision sensors and probes, data acquisition devices, dedicated software, etc.) properly controlled and calibrated, it is necessary to contact companies that are specialized in this type of activity. Emptying the steam generator ...
  • Page 51: Repairs And Spare Parts

    TLVi/15 9 REPAIRS AND SPARE PARTS Only original RAYPA spare parts guarantee a safe and correct use and operation of the device. Before making any repairs to the equipment, disconnect it from the electrical network. In case of any breakdown, it is advisable to consult your usual dealer first.
  • Page 52: Electrical Diagram

    TLVi/15 11.2 Electrical diagram 52/64...
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  • Page 60 TLVi/15 11.3 Piping 60/64...
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  • Page 62: Declaration Of Conformity

    TLVi/15 11.2 Declaration of conformity 62/64...
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