Related Manuals for Raypa TLV-40MP
Summary of Contents for Raypa TLV-40MP
- Page 1 TLV-MP-CEi/01 INSTRUCTION MANUAL FOR USE AND MAINTENANCE AUTOCLAVES FOR STERILIZATION Models: TLV-40MP / TLV-60MP / TLV-80MP / TLV-100MP 1/56...
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Page 2: Table Of Contents
TLV-MP-CEi/01 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 TLV-MP-CEi/01 Logging Menu ......................18 5.4.1 Protocol view ....................18 5.4.2 Print protocols .................... 19 5.4.3 Printing template ..................20 5.4.4 Print traceability label ................. 20 5.4.5 Traceability of labelled items ..............21 5.4.6 Batch control ....................21 Settings ........................21 5.5.1 User settings ....................
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Page 4: Packing List And Accessories
TLV-MP-CEi/01 1 PACKING LIST AND ACCESSORIES 1.1 Included elements 1 steam sterilizer 4 pressure hoses 1 instruction manual 2 dosing tubes 1 dosing pedal 1 dosing hose holder 2 dosing hose fixings 1 capacity meter for inner tank ... - Page 5 TLV-MP-CEi/01 Water purifier external water Ref. ECOPUR-500 supply tank Ref. TANK-KLL Private cloud server Software licenses Ref. SERVER Ref. CLOUD-B Ref. CLOUD-P Automatic filling pump Doser To feed the autoclave Ref. DW-MP from external container or directly from a water source distilled.
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Page 6: Safety
TLV-MP-CEi/01 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. Security labels: Risk of entrapement. -
Page 7: Symbols
TLV-MP-CEi/01 2.1 Symbols They identify dangerous situations and precautions that have to be taken. WARNING Information of a risk that can be dangerous for the health or damage the device. Proceed following the indicated procedure. ELECTRIC RISK Risk of electrical accident if accessing to the zones indicated by this symbol, or during operations indicated in this manual. -
Page 8: Modifications
TLV-MP-CEi/01 2.5 Modifications All modifications made in the instrument, in its functioning and in its accessories or spare parts, can expose the operator to some risks unforeseen in this manual. Any modifications need the written consent of R T Espinar, S.L. 2.6 Safety measures This equipment is provided with safety features to assure a suitable operation:... -
Page 9: Description Of The Equipment
TLV-MP-CEi/01 3 DESCRIPTION OF THE EQUIPMENT 1. PC Panel 2. Inlets to inner tank. 3. Pusher OPEN-CLOSE cover. 4. Dosing pump head. 5. Culture medius outlet. 6. Dosing selector. 7. Mixer speed control. 8. Main switch. 25. Drain valve. 24. USB-Data download 9. -
Page 10: Installation
TLV-MP-CEi/01 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 11: Connection To The Mains
TLV-MP-CEi/01 It is very important that connections 12 and 16 are properly attached to a drain. During the operation of the equipment, there is pressure and temperature in these pipes, producing vibrations that can cause the tube to come out of the drain if not properly attached, in which case there is a risk of burning. - Page 12 "CAB-2" in position. 3- Fit the head (10) into the pre- assembled additional head "CAB-2". Assembly complete. Characteristics according to model: Model References TLV-40MP TLV-60MP TLV-80MP TLV-100MP Maximum capacity for preparing culture media L Minimum capacity for preparing 5 or 5...
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Page 13: Controller/Programmer Description
TLV-MP-CEi/01 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 You can also enable or disable the option to create new users. 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.
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Page 15: Sterilization Menu
TLV-MP-CEi/01 5.2 Sterilization Menu 5.2.1 Select a program 1. After completing the access, the “Sterilization” tab will be displayed. 2. The available programs will be displayed on the initial screen. The screen displays 4, but moving the screen down will show the rest. 3. -
Page 16: Raypatrace
TLV-MP-CEi/01 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 17: 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 18: 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 19: Print Protocols
TLV-MP-CEi/01 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 20: Printing Template
TLV-MP-CEi/01 5.4.3 Printing template Ticket format for TLV-MP St: Stage FL: Filling SF11: 1 Pre-vacuum SH: Heating SS: Sterilization SC: Cooling 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. -
Page 21: Traceability Of Labelled Items
TLV-MP-CEi/01 5.4.5 Traceability of labelled items 1- Search for the "Logging" tab. 2- Press the Scan icon located in the upper right side of the screen. 3- A pop-up window will appear. Scan the barcode on the sterilized product label with the barcode scanner. -
Page 22: Network Settings
TLV-MP-CEi/01 To delete the account press the "Delete" button 5.5.2 Network settings 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 23 TLV-MP-CEi/01 Online Mode If the user creates a RAYPAcloud account directly from the device or via the web, a backup copy of the protocols and parameters will be saved in the RAYPAcloud online storage. In the settings, you can enable or disable the Online mode by activating or deactivating the corresponding box.
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Page 24: Language 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 25 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 26 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.
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Page 27: Audit Logs (Only Visible With Fda-Enabled Mode)
TLV-MP-CEi/01 5.5.6 Audit Logs (Only visible with FDA-enabled mode) It will show the entire operations log performed with each of the user accounts. In Admin mode, the log can be exported to a USB stick and if you have a RAYPAcloud account, they will also be saved in the cloud automatically. - Page 28 TLV-MP-CEi/01 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. If the export fails, remove the USB stick and restart the computer.
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Page 29: Calibration
TLV-MP-CEi/01 Batch control After sterilization, it should be indicated if the indicator is correct, or wait to confirm it later. 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. -
Page 30: Logout
TLV-MP-CEi/01 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 31: Raypacloud Software
TLV-MP-CEi/01 5.9 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 32 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 33 TLV-MP-CEi/01 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.
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Page 34: Connection To The Local Private Cloud Server
TLV-MP-CEi/01 5.9.1 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 35 TLV-MP-CEi/01 The manual front valve or drain Close the valve which has been valve has been opened during the MANUAL VALVE OPEN detected as opened. cycle. Reset manually once cold. If the error RESET SAFETY The safety thermostat has tripped. repeats, check steam generator and THERMOSTAT safety thermostat.
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Page 36: Load Distribution
There is also the possibility of working with the F0 function or with time using the pre-vacuum option. For more information, consult the RAYPA technical service. For proper sterilization, arrange the instruments in the trays as indicated below: Instruments made of different metals (stainless steel, tempered steel, brass, aluminum etc.) must be placed in different baskets, or in any case sufficiently... -
Page 37: Start Up
TLV-MP-CEi/01 When the instruments are not made of stainless steel, a non-woven tissue- type water-repellent paper must be placed between the container and the instruments to avoid direct contact between the two materials. In any case, the instruments must always be sufficiently separated from each other. - Page 38 TLV-MP-CEi/01 Water quality (cooling) Preferably use decalcified water to avoid clogging of pipes. Automatic filling with mains water (see section “WATER QUALITY”) In this case the tank will be filled when the cycle starts, with the entire process being performed automatically.
- Page 39 TLV-MP-CEi/01 Close the lid with the side button (3). In some cases, some manual pressure may be necessary, helping to lower the lid to close it properly (e.g., if the autoclave has not cooled sufficiently). Select the appropriate program and press "START". If the lid is not closed properly or the device has no water, a message will appear on the screen.
- Page 40 TLV-MP-CEi/01 If during the cycle, there has been an abnormal situation or the “STOP” button is pressed, the corresponding error message will appear on the screen and the device will perform the appropriate operations for its safe opening. Sterilization After starting a sterilization program, the data will appear on the screen: The device will start to warm up and a timer (total counter) will appear indicating the time elapsed since the start.
- Page 41 TLV-MP-CEi/01 In a liquid program is used, in order to avoid sudden temperature changes, a cooling process is carried out. Once this phase is finished, an end of process message will appear with an acoustic warning. If all the phases have been successfully completed, the end of cycle message that will appear on the screen will be “PROGRAM COMPLETED SUCCESSFULLY”...
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Page 42: Dosing Configuration
TLV-MP-CEi/01 Operation of the dosing pump The dosing pump is equipped with a head that allows access to the pipe for extraction. Simply pull upwards on the top of the head. It is compatible with several sizes of tubing which, combined with control of the speed, allows for a wide variety of flow rates. - Page 43 TLV-MP-CEi/01 Click on the header of the WORK Screen to access the Dosing configuration. Enter the values (See section DOSING Screen). Once the values have been configured, Dispensing can begin. Dosing Make sure the tubes are correctly driven to a proper container (see section 4.1) Close the pump head as indicated in the section TUBE LOADING.
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Page 44: Calibration Port
It is very important to ensure total tightness when passing the corresponding probes, since the port is connected with the pressure vessel. For further information, please contact Raypa Technical Service. In case an OQ/PQ qualification has to be performed, one of the following... -
Page 45: Maintenance
TLV-MP-CEi/01 After the cycle, the icon (compressor / purge) is used to purge the dosing line. The compressor will start running. The pressure will start building up, until achieving the selected counterpressure in the program. The front manual valve has to be opened carefully and slowly. - Page 46 TLV-MP-CEi/01 The ordinary maintenance described below, consists of easy manual operations and preventive interventions with the use of simple instruments. IN THE EVENT OF REPLACEMENT OF COMPONENTS OR SPARE PARTS OF THE AUTOCLAVE, REQUEST AND/OR USE ORIGINAL SPARE PARTS ONLY. Ordinary Maintenance Program The table summarizes the interventions to be carried out in the autoclave in order to always keep it in an efficient state of operation.
- Page 47 TLV-MP-CEi/01 - Do not use acid cleaning agents, chlorine solvents or salt solutions for cleaning. - Do not allow limestone deposits or other substances to accumulate in the sterilization chamber, in the lid or in the gasket; perform a periodic cleaning in such regard.
- Page 48 TLV-MP-CEi/01 8.2.5 Bacteriological filter sterilization To sterilise the bacteriological filter, it must be pulled from the machine in order to remove it. 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 ...
- Page 49 TLV-MP-CEi/01 5) Press the cover until it is firm (fig. 1.20). 6) Remove excess paper using the toothed belt (fig. 1.21). 8.2.9 Safety valve maintenance This operation is required to ensure the proper functioning of the valve in a long- lasting manner.
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Page 50: Repairs And Spare Parts
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. -
Page 51: Warranty
TLV-MP-CEi/01 10 WARRANTY This equipment is warranted for one year, against any workmanship defect or defective part. The warranty does not cover damages caused by improper use or for causes beyond the control of R T Espinar, S.L. Any handling of the equipment by personnel not authorized by R T Espinar, S.L. automatically voids the warranty. -
Page 52: Annexes
TLV-MP-CEi/01 11 ANNEXES 11.1 Electric diagram 52/56... - Page 53 TLV-MP-CEi/01 53/56...
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Page 54: Piping Diagram
TLV-MP-CEi/01 11.2 Piping diagram 54/56... -
Page 55: Declaration Of Conformity
TLV-MP-CEi/01 11.3 Declaration of conformity 55/56... - Page 56 TLV-MP-CEi/01 56/56...
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