Related Manuals for INFIMED NEXUS OL-01
Summary of Contents for INFIMED NEXUS OL-01
- Page 1 User Manual OPERATING LIGHT NEXUS OL-01 and OL-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 lamp has been classified as class I, according to rule 13.
- Page 3 Safety ............................... 4 1.1. General safety remarks ....................... 4 1.2. General remarks concerning the safe use of the product............4 1.3. Technical parameters ........................5 1.4. General requirements ......................... 9 1.5. Products description........................9 1.6. Description of the light elements ....................10 1.7 Electromagnetic compatibility ....................
- Page 4 1. Safety The product was designed and manufactured in order to ensure the safe use and maintenance of the device. In order to use the lamp safely it is necessary to read, understand and follow the rules set out in this manual. This marking has been placed on parts and mechanisms whose handling contrary to the guidelines of the instructions may result in a hazard to the safety of the patient or the staff.
- Page 5 (especially shorter distances) the permissible values of optical radiation power may be exceeded. Failure to following the above requirements, principally the ones concerning washing and disinfecting will result in a loss of warranty for the product 1.3. Technical parameters InfiMED Technical parameters of operating lights OL-01 OL-02 Nexus:...
- Page 6 >94 >94 Red color rendering index [R9] Irradiance Ee in DRef = 1000 mm <570W/m2 <520W/m2 Maximum irradiance Etotal in DMI = 850 mm < 690 W/m2 < 620 W/m2 Integrated system of endo lighting with adjustable Green light (white light)* Green light (white light)* intensity <40,00 <40,00...
- Page 7 Configuration of lights NEXUS OL-01 and OL-02 Single ceiling suspension Wall suspension Mobile base and triple ceiling suspension (two arms with rotation n<360°, third one with rotation nx360°) Triple ceiling Mobile base suspension...
- Page 8 Double ceiling suspension with rotation nx360° Double ceiling suspension "T" type (two arms with rotation n<360°) Double ceiling suspension with rotation nx360° for rooms with low height...
- Page 9 1.5. Products description Operating lights NEXUS OL-01 and OL-02 use LED diodes as light source. They are designed to light operating field during surgical treatments and operations. The most important features are very good, persistent technical parameters, very low temperature radiation or very long working time.
- Page 10 1.6. Description of the light elements Example of the structure of light heads: NEXUS OL-01 Side panel of the light head Main, central panel of the light head Control Sterile panel holder NEXUS OL-02 Main, central panel of the light head...
- Page 11 1.7 Electromagnetic compatibility Medical device: OL-01 and OL-02 is an electrical device. Electrical devices are a source of electromagnetic radiation and are themselves subject to its influence. The use of an electrical appliance requires the use of proper precautions related to electromagnetic compatibility.
- Page 12 Assembly the system of ceiling plate to the existing ceiling according to the Building Preparation Manual for the Infimed operating and treatment lights. d) Install suspension of the lamp, depending on lamp version (installation according to Installation manual on the holder provided by manufacturer)
- Page 13 The product is intended for installation and operation only in closed rooms with the following environmental conditions: - temperature: 25⁰C (77⁰F) ± 10⁰C (18⁰F) - humidity: 50% ± 25% - atmospheric pressure 700 to 1060 hPa 3. Use and operation 3.1.
- Page 14 Lamp parameters control panel Switching between light head functions shadowless function (green on, white inactive) Light head parameters adjustment On/off button LCD touch panel with control of camera Switching between light head functions Camera parameters adjustment Camera On/off button Functions can be adjusted from the panel: - Zoom, - Rotate the camera, - Manual and auto iris...
- Page 15 - synchronized control of the parameters of both head lights. Membrane keyboard Power supply indication (main/backup) Light head parameters adjustment On/off button...
- Page 16 Intelligent shadowless function (additional option) shadowless function (green on, white inactive) Activation by pressing the symbol in the upper right corner causes the activation of sensors detecting obstacles (e.g. surgeons' heads) - the operation is signaled in green. Sensors switch off the light panels covered with an obstacle above the operating field, and increase the remaining ones to maintain the lighting parameters in the operating field.
- Page 17 3.2. Adjustment by regulation holder (additional option) After the light head is turned on, it is possible to change the light parameters of the lamp using the sensor and the sterilized handle. Switching the functions is done by moving the hand under the sensor located in the light head, in the following order: intensity adjustment, field adjustment, color temperature adjustment, and the selected function is highlighted in blue.
- Page 18 3.3. Positioning of the light heads depending on the spring arm Ondal Arms For positioning of the lamp head are used: sterilized regulation holder and holders placed on the edges of the lamp head. The height is adjustable by suspension arms. It is possible to adjust the tension arm.
- Page 19 Spring arm Inside ring Space for inside ring Swivel Swivel cover Spring arm Hinge mechanism SPR parts Rotary arm Direction for spring increasing – for larger weights Spring arm Direction for spring decreasing – for smaller weights Iambus key Adjustment of a spring arm Do not adjust the function screw.
- Page 20 Functional screw Spring arm Functional screw place 4. Mains supply and battery charging Mains supply is indicated on the ceiling cover: green LED - operating main network, orange LED - operating emergency network. If the lamp is equipped with a charger which enables the charging of the lamp batteries, it should be connected to mains with supply parameters according to rating level.
- Page 21 Green LED – batteries charged Orange LED – battery charge on a level of 60% - you may connect and charge Red LED – battery charge below a level of 30% - charging of batteries is absolutely required The charging process may be started when the orange LED is lighted. After connecting the power, the green LED will light.
- Page 22 In the case the lamp is not fully operational, that is, the parameters are not in accordance with the description in the user’s manual, its use is not allowed. You should contact the supplier, maintenance service or the manufacturer. The use of a defective device may cause damage for which the user will be responsible, and for which the manufacturer is not responsibility.
- Page 23 In order to ensure a long and trouble-free operation of the lamp only original parts provided by the manufacturer should be used. Since the product contains elements which may create an environmental hazard, the used parts have to be disposed in accordance with the environmental protection regulations. In case of battery replacement, the manufacturer is required to reclaim the used batteries.
- Page 24 b) insecure fixation of sterilized handle - replace the handle with the new one In case of doubts contact the manufacturer in order to obtain the necessary help and explanations. 12. Product liquidation The user, making decision of resigning from further product exploitation, is obliged disinfect the product (the non-disinfected product according to rules concerning environmental protection is dangerous waste).
- Page 25 13. Electromagnetic emissions Medical devices operating lights OL-01 and OL-02 should be used in electromagnetic environment specified below. The customer or the user of medical devices the OL-01 and OL-02 should assure that they are used in such an environment. Emission type Classification Explanations and guidances...
- Page 26 Medical devices operating lights OL-01 and OL-02 should be used in electromagnetic environment specified below. The customer or the user of medical devices the OL-01 and OL-02 should assure that they are used in such an environment. IEC 60601-1-1 Immunity test Compliance level Explanations and guidances Test’s level...
- Page 27 14. Labels Labels on operating light NEXUS OL-01 and OL-02 : Safety instructions for rechargeable lamps Rating label NEXUS OL-01 Rating label NEXUS OL-02 Potential equalization socket...
- Page 28 Rating label Description of designation: 1. Manufacturer’s name, logo and address 2. Serial number 3. Power parameters, power consumption 4. Additional markings, e.g. application parts, tightness classes, etc 5. Product symbol 6. CЄ mark 7. Code UDI-DI-PI...
- Page 29 UDI-DI-PI code explanation...
- Page 30 Data presented on the label: No. Element: Pictogram to use Company logo Manufacturer's name and address Name Operating Lamp Part Number CE mark – compliance of the product with the requirements of the MDR Regulation 2017/745 IP rating Serial Number Production date Read the User’s Manual Remark...
- Page 31 Annex no. 1 Agents recommended for cleaning and disinfection of surfaces of products and elements made of aluminum, epoxy coated steel and plastics. STEEL AND AGENT MATERIAL DISTRIBUTOR/MANUFACTURER ALUMINUM Aesculap-Chifa Sp.z o.o. ELISEPTOL ul. Tysiąclecia 14 64-300 Nowy Tomyśl tel: 061 4420100 fax: 061 4437505 Bochemie PL Sp.
- Page 32 Annex no. 2 Card of repairs and inspections of product Operating light 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) inspection or repair...
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