Related Manuals for INFIMED OPERA IS-01
Summary of Contents for INFIMED OPERA IS-01
- Page 1 User Manual INTEGRATION SYSTEM OPERA IS-01 Serial number …………………………….. Edition 3.1 September 2024 PROJECT……………………………...
- Page 2 Manufacturer: INFIMED Spółka z ograniczoną odpowiedzialnością ul. Kabaty 1 34-300 Żywiec Polska WWW.INFIMED.PL Tel/fax +48 33 861 40 96 SRN: PL-MF-000015633 VAT id no.: PL 553 251 29 67 REGON 243274947 In accordance with Annex VIII to Regulation (EU) 2017/745 of the European Parliament and of the Council , the product has been classified as class I, according to rule 13.
- Page 3 Infimed Sp. z o. o. is not liable for damages that result directly or indirectly from improper use of this document. All rights reserved. No part of this document may be reproduced in any form (by printing, photocopying, etc.), or processed, copied or distributed using electronic systems without the written...
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Page 4: Table Of Contents
Contents: Description of INFIMED Opera system .................... 5 INFIMED Opera system interface ....................9 Home screen ............................9 Operating Table Tab .......................... 10 Operating Light Tab ........................... 12 Camera ............................14 Air Conditioning Tab .......................... 15 Operating Room Tab ......................... 16 Clock Tab ............................ -
Page 5: Description Of Infimed Opera System
The connection between the glass and the panel guarantees tightness and facilitates disinfection. • Infimed Opera IO input/output module, which provides communication between the control unit and other devices. Depending on the configuration, the system may be based on several such modules with power supplies, placed in plastic housings. - Page 6 • Wiring. There is a nameplate on the device (on the OperaIO I/O module and control panel): Description of markings: 1. Manufacturer's name, logo and address 2. Serial number 3. Power supply parameters, power consumption 4. Additional markings, e.g.: applied parts, tightness classes, etc. 5.
- Page 7 Explanation of the UDI-DI-PI code Data presented on the label: No. Element: Pictogram to be used Company logo Manufacturer's name and address Product name Integration system Catalog number CE mark – product compliance with the requirements of the MDR 2017/745 Regulation IP protection class Second class of protection against electric shock Serial number...
- Page 8 No. Element: Pictogram to be used Date of production Read the Instructions for Use Note Medical device UDI code The manufacturer reserves the right to make changes to the product design in connection with the use of newer technological solutions that improve the functionality of the product.
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Page 9: Infimed Opera System Interface
2. INFIMED Opera system interface To turn on the control panel, press the monostable button, which is usually located under the control panel. After loading, which may take a few seconds, the Opera application with a graphical interface will be launched. -
Page 10: Operating Table Tab
Operating Table Tab To switch to the operating table control tab, touch the button: The buttons will be locked by default. To unlock, please hold down the button with the padlock icon. Once unlocked, the following should appear on your screen:... - Page 11 Functions and buttons: 1. Up movement, 2. Down movement, 3. Trendelenburg tilt, 4. Reverse Trendelenburg tilt, 5. Tilt left, 6. Tilt right, 7. Longitudinal slide towards legs, 8. Longitudinal slide towards head, 9. Flex, 10. Reflex 11. Backrest up, 12. Backrest down, 13.
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Page 12: Operating Light Tab
Operating Light Tab To switch to the Operating Light control tab, touch the button: The following tab should appear on the screen. The tab has the following functions: 1. Button for switching to the next head (the active head number is displayed next to the pictogram - the button is not displayed if only one lamp is configured), 2. - Page 13 Lamp endo mode: 1. Increasing the brightness in endo mode using the button, 2. Decreasing the brightness in endo mode using the button, 3. A bar representing the current lighting brightness setting in endo mode (it is possible to change the parameter setting by touching the bar),...
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Page 14: Camera
Camera The camera tab has the following functions: 1. Zoom + cameras, 2. Zoom – cameras, 3. Rotate camera left, 4. Rotate camera right, 5. Enable Auto-focus, 6. Freeze frame mode, 7. Turn camera on/off. -
Page 15: Air Conditioning Tab
Air Conditioning Tab To switch to the air conditioning tab, touch the air conditioning button: The following tab should appear on the screen. The tab has the following functions: 1. Setting the desired temperature using the touch slider, 2. Displaying the current temperature setting, 3. -
Page 16: Operating Room Tab
Operating Room Tab To switch to the "Operating Room" tab, please press the button: The following tab should appear on the screen: The tab has the following functions: 1. General lighting on/off button, 2. Saved name of assigned door (for example "Corridor"), 3. -
Page 17: Clock Tab
Clock Tab To switch to the clock tab, please press the button: The following tab should appear on the screen. This tab displays the current time and date. -
Page 18: Timer
Timer To quickly switch to the stopwatch tab, please press the button: The following tab should appear on the screen: The tab has the following functions: 1. Displaying the remaining time, 2. Start/pause, 3. Changing the time setting, 4. Deleting and stopping the timer. While the timer is running, the tab can be changed to another at any time, the timer will continue to run in the background, which means that when you return to this tab, it will continue to run. -
Page 19: Screen Lock
Screen lock To quickly switch to the stopwatch tab, please press the button located at the top of the screen: The following icon should appear on the screen: The screen lock can be used, for example, when disinfecting the screen. To unlock the screen, please hold the padlock symbol for a moment. -
Page 20: Possible Problems And Displayed Warnings
3. Possible problems and displayed warnings In the event of a lack of connection with external devices, the relevant fields are greyed out or a warning message is displayed. In the event of a lack of connection to the lamp (for example, no power supply), the options related to it become inactive and the following message is displayed: The Opera IO module in this project is connected to the air conditioning unit, in case of power supply/connection problems, it is not possible to change the settings or read the air conditioning... -
Page 21: Product Life Cycle
5. Product life cycle The manufacturer specifies the product lifespan as 10 years. 6. Washing and disinfection For cleaning and disinfection, use detergents that do not contain active oxygen or chlorine. After disinfection, rinse the product with distilled water to eliminate streaks. Use a dry, soft, sterile cloth to thoroughly dry it. -
Page 22: Liquidation Of The Product
- checking the general technical condition - checking the functionality - checking the electrical installation 9. Liquidation of the product When deciding to discontinue use of the product, the user is obliged to disinfect it (a product that is not disinfected in accordance with applicable environmental protection regulations is hazardous waste). -
Page 23: Electromagnetic Emissions
11. Electromagnetic Emissions The medical device: IS-01 is intended for use in the electromagnetic environment specified below. The user should ensure that the medical device: IS-01 is used in such an environment. Emission type Classification Explanations and guidance Medical Device: IS-01 generates RF energy only for its own internal RF Emissions Group 1 functions. - Page 24 Medical device: IS-01 is intended for use in an electromagnetic environment with the following characteristics. The user should ensure that the medical device: IS-01 is used in such an environment. IEC 60601-1-2 Immunity Immunity level Explanations and guidance Test level Portable radio communication...
- Page 25 Appendix No. 1 Recommended agents for cleaning and disinfecting surfaces of products and elements made of glass, aluminum, powder-coated steel and plastics STEEL AND PLASTIC AND PREPARATION DISTRIBUTOR/MANUFACTURER ALUMINUM GLASS Aesculap-Chifa Sp.z o.o. ELISEPTOL ul. Tysiąclecia 14 64-300 Nowy Tomyśl tel: 061 4420100 fax: 061 4437505...
- Page 26 Appendix No. 2 Card of performed repairs and product inspections Product type......Serial number …......Date of purchase ......…… Notes noted during the inspection or Signature of the Inspection type Person performing Inspection Inspection person performing repair (annual, semi- the inspection or the inspection or or repair annual)
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