Related Manuals for INFIMED VIVAX OT-02
Summary of Contents for INFIMED VIVAX OT-02
- Page 1 User Manual OPERATING TABLE VIVAX OT-02 Serial no …………………………….. Edition 3.1 September 2024...
- 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 NIP 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 table has been classified as Class I, according to rule 13.
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Page 3: Table Of Contents
Safety ............................... 5 1.1. General safety remarks ....................... 5 1.2. General remarks concerning the safe use of the product............5 1.3. Technical parameters of operating tables InfiMED VIVAX OT-02 ..........7 1.4. General requirements ......................... 8 1.5. Description ..........................8 1.6. - Page 4 3.5. Table mobility ..........................20 Batteries charging ........................21 Static charge prevention ......................21 Collision hazard ......................... 22 Assessment of correct operation ....................22 Defects and faults ........................22 Cleaning and disinfecting ......................23 10. Emergency power supply (optional) ..................23 11.
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Page 5: Safety
1. Safety The product has been designed and manufactured in order to ensure the safe use and maintenance of the device. In order to use the table safely it is necessary to read, understand and follow the rules set out in this manual. This sign was placed on parts and mechanisms, which may cause a hazard to the patient’s or staff’s safety when not operated in accordance with the manual’s guidelines. - Page 6 - When using the operating table near high-frequency medical devices and defibrillators you should observe the recommendations contained in the user’s manuals of the devices in question. Improper use may cause dangerous accidents. There is a danger of inflicting serious burns on the patient through contact with metal parts of the table or its equipment.
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Page 7: Technical Parameters Of Operating Tables Infimed Vivax Ot-02
1.3. Technical parameters of operating tables InfiMED VIVAX OT-02 Total length of the table with 4 and 5 sections or modular table top 2100 mm Total length of the table with a one-piece top for X-rays 2200 mm Total length of the table with 6 sections table top... -
Page 8: General Requirements
1.5. Description The INFIMED VIVAX OT-02 operating table is made of stainless, acid-resistant steel and is designed to support the patient during all procedures and surgical and specialist operations. The table InfiMED VIVAX OT-02 is equipped with multisectional or one-sectional table top, X-Ray permeable, on mobile base with central braking system. -
Page 9: Description Of Table Elements
1.6. Description of table elements Description of the components of the INFIMED VIVAX OT-02 table with a segmented top – version: OT-02-522, OT-02-422, OT-02-522OHN, OT-02-422OH, OT-02-525, OT-02-525OHN, OT-02-526OHN Description Description Head rest segment Mobile base with central lock Head rest adjustment lever... - Page 10 Description of the elements of the INFIMED VIVAX OT-02 table with shoulder arthroscopy backrest, version OT-02-322OH Description Description Specialistic head rest segment Foot rest abduction adjustment Head rest adjustment lever Fixation of foot rests to seat segment Attaching the headrest to the...
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Page 11: Electromagnetic Compatibility
Description of the construction elements of the INFIMED VIVAX OT-02 table with a one- piece X-ray permeable table top – version OT-02-722HP Description Description Mobile base with central lock Antistatic wheels Column rubber cover Rotation wheel Column cover Potential equalization socket... -
Page 12: Transport And Start-Up
Recommended distances between portable radio communication equipment and the product Rated maximum output power of 150 kHz to 80 MHz 150 kHz to 800 MHz 800 MHz to 2.5 GHz transmitter Rated maximum distance in meters distance in meters distance in meters transmitter output power in watts 0.01... -
Page 13: Installation And First Start-Up
a) Make sure that the transport packaging has been left in the room where the table is to be used for a long time b) Open the shipping box and remove the table protection materials c) Take out and put aside all the additional equipment provided. d) Place the footrests, backrest, headrest in the "zero"... -
Page 14: Use And Operation
3. Use and operation 3.1. Description of remote controller and wireless remote controller 5.10 5.11 5.12 The cable remote is connected to one of two a socket located below the table top. In order to do this, place the plug in the socked (appropriate profiling of the plug prevents incorrect connection) and then tighten the mounting ring. -
Page 15: Operations Implemented With The Remote Controller
used to “zero” the table top position. Pressing and holding this button will result in the table seat and back rest taking a horizontal position in relation to the floor (optionally also backrest segment and kidney bridge, as well as longitudinal slide if the anti-collision system works). In tables equipped with electrohydraulic table top drive or electrohydraulic longitudinal slide there is a limitation of angular ranges of movements of individual functions by anti-collision system that prevents damage to table elements. -
Page 16: Electro-Hydraulic Table Top Segments Angle Change
movement if the anti-collision system works). If the "4" button is released earlier, the table top will remain in the position it has currently reached. 3.2.4. Electro-hydraulic table top segments angle change The change of the angular position of the backrest segment is carried out within the range specified in the technical parameters of the table. -
Page 17: Additional Control Panel
Operating table equipped with alternative drive has additional mechanic-hydraulic system controlled electrically with its own power supply. To perform any hydraulic movement of the table you should push green button „I”, and then button indicating particular movement. Chosen function will be signalized with lighting diode. -
Page 18: Operations Implemented With Mechanical Elements
function. The function is performed as long as you press the button. Button „1” is used for „leveling” of table top. After pushing and pressing his button seat segment will be adjusted to the level in comparison to the ground. Additional control panel after turning on, will turn off automatically after 30 seconds. -
Page 19: Footrests Angle Adjustment
performed by gas springs. However, they only support the user in the changes of position, and obtaining a proper angle requires the use of physical force. The optional shoulder arthroscopy back rests additionally include two (lateral) removable segments for shoulder surgery. The removable segments are mounted and disassembled using pressure knobs. To attach the side segment, make sure that the pressure knobs are unscrewed tightly enough, then take the segment (standing behind the backrest) and slide it into the mounting socket in the frame. -
Page 20: Assembly And Disassembly Of Selected Elements
3.4. Assembly and disassembly of selected elements 3.4.1. Assembly and disassembly of headrest (or extension segments) The headrest (or extension segments of modular table top) is mounted to the backrest segment. For this purpose, there are used dedicated headrest assembly clamps. In the backrest segment there is a yoke with the bolt placed in upper part of headrest joint (or extension segment). -
Page 21: Batteries Charging
4. Batteries charging The table is equipped with a charger which enables the charging of the table batteries, of both main and alternative drive. The charging system is started by inserting the appropriate end of the power cord in the socket located in the table casing, and putting the plug in the electric power socket, and toggling the switch located in the table casing from position 0 to 1. -
Page 22: Collision Hazard
6. Collision hazard It is possible to set the table so that in some extreme positions, especially when using additional equipment mounted on side rails, mechanical collisions are possible. You should pay attention to avoid such a situation, as not to damage the table or additional equipment. You should operate the table consciously, with caution and full responsibility. -
Page 23: Cleaning And Disinfecting
9. Cleaning and disinfecting For the washing and disinfecting of the product you should use washing agents which do not contain active chlorine or oxygen. After disinfecting, the product should be washed with distilled water in order to remove water stains. Use a soft, sterile cloth for a thorough drying. Do not disinfect the product in a disinfecting chamber. -
Page 24: Removing Of Potential Problems And Diagnostic Of The Table
Only a positive result of the inspection is a basis for further use of the product. Each 12 months the following should be performed. Each 24 months the following must be performed: - detailed technical inspection - functionality testing - electric and hydraulic installation testing - lubrication of movable elements In order to ensure the proper, safe operation of the table the user should check the technical condition of the device at least once every 6 months. - Page 25 1. Give the liquidation order to the producer. 2. Give the liquidation order to the company, having necessary attestation for liquidation or neutralization products in the way assuring protection of life, health of people and environmental protection. 3. Undertake liquidation itself, provided having the staff able to disassemble the product.
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Page 26: Additional Accessories
15. Additional accessories - One position clamp EB-01 - Multi position clamp EB-02 - Knee support EB-03 - Angle arm support EB-04 - Arm support EB-05 - thigh holder EB-06 - Side-shoulder support EB-07 - Side support EB-08 - Anesthetic frame EB-09 - Anesthetic frame with adjustable width EB-10... - Page 27 -Leg support EO-03 -Support for plastering EO-04 -Heel holder EO-05 -Foot support EO-06 -Clamp for orthopedic attachment supports EO-07 - Knee operation attachment for orthopedic attachment (without extension EO-08 device) - Hip support for side position EO-09 - Support for orthopedic attachment arms EO-10 - Knee support for side positions EO-11...
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Page 28: Electromagnetic Emissions
16. Electromagnetic emissions Medical device operating table OT-02 is to be used in electromagnetic environment specified below. The customer or the user of medical device the OT-02 should assure that it is used in such an environment. Electromagnetic environment – guidance Emission type Classification Medical device operating table OT-02 produces energy with radio... - Page 29 Medical device operating table OT-02 is to be used in electromagnetic environment specified below. The customer or the user of medical device the OT-02 should assure that it is used in such an environment. IEC 60601-1-1 Immunity test Compliance level Electromagnetic environment - guidance Test’s level Portable and mobile RF communications...
- Page 30 17. Table labels The following labels can be found on the covers and frames of the table top: Read the user’s manual Transport position Headrest angle adjustment Backrest angle adjustment Foot rest angle adjustment Longitudinal slide Rotation of footrests...
- Page 31 Disinfection Brake lever Batteries charging Rating label Potential equalization socket...
- Page 32 UDI-DI-PI CODE...
- Page 33 Rating label Description of designations: 1. Manufacturer’s name, logo and address 2. Serial number 3. Type of operation for elevating column – 2 minutes of uninterrupted work require 18 minutes break 4. Designation of the application part (B type) and IP class (IPX4) 5.
- Page 34 Data presented on the label: No. Element: Pictogram to be used Company logo Name and address of the manufacturer Product name Operating Table Catalog number CE mark - product compliance with the requirements of MDR Regulation 2017/745 IP protection level Application part (type B) Serial number Production date...
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Page 35: Placement Of Labels On The Table's Construction
18. Placement of labels on the table’s construction Description: 1 – Description of the battery charging 6 – Longitudinal movement of the table method 7 – Back rest angle adjustment 2 – Rating label code UDI-DI-PI 8 – Head rest angle adjustment 3 –... - Page 36 Annex no. 1 Agents recommended for cleaning and disinfection of surfaces of products and elements made of stainless steel and antistatic polyurethane. ANTISTATIC AGENT TAINLESS STEEL ISTRIBUTOR RODUCER POLYURETHANE Aesculap-Chifa Sp.z o.o. ELISEPTOL ul. Tysiąclecia 14 64-300 Nowy Tomyśl tel: 061 4420100 fax: 061 4437505 Bochemie PL Sp.
- Page 37 Annex no. 2 Card of repairs and inspections of product Operating table type ......Serial no …......Purchase date....………. Inspection Inspection type Sign of person Inspection Person performing Comments concerning inspection or or repair (annual, six- performing inspection or repair repair date month)
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