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WARNINGS
CLEANING INSTRUCTIONS Disconnect the LED from all components of the system (magnifying system, Control Unit) before cleaning. Use a microfiber cloth to clean the lens. The LED can be cleaned with a soft cloth soaked with a gentle detergent solution. Do not immerse or spray any components into or with detergents and other liquids. This device cannot be sterilised. Make sure the device is completely dry before use
Operating conditions Temperature Relative humidity Atmospheric pressure
da +10°C a +30°C 10% a 90%; da 50 kPa a 106 kPa da -10°C a +50°C 10% a 90% da 50 kPa a 106 kPa
Instructions for use - LynxPro LIGHTING SYSTEM Thank you for your trust in us and congratulations on your choice. Read the following information before using the device.
EN | English
Read the following warnings carefully before using the device. Failure to follow these safety instructions could result in fire, electric shock, injury or damage to the LED lighting system or to other property. Do not use the device if it has been damaged. Contact your authorised dealer. Do not tamper with or disassemble any component of the system. Do not attempt any repairs unless expressly indicated. The LynxPro device has a built-in rechargeable lithium battery, which cannot be replaced or disassembled by the user or by unauthorized personnel. The battery must be replaced and disassembled exclusively by personnel authorized by Univet. Do not try to change the battery by yourself: improper substitution or the use of wrong spare part can cause risk of explosion. Do not expose the device to conditions that could ignite the battery. Avoid contact with heat sources or open flames. Do not use in spaces with flammable anesthetic mixtures. Do not immerse any component in liquid substances. Prevent liquid substances from entering the slots or the connection port. Do not look directly at the light emitted by the LED or direct the light to the patient’s eyes. Use the supplied components only: do not combine the components of the system with other lighting systems or electronic equipment. Use only the power supply if supplied or compliant with technical specifications indicated in this information note. Avoid sudden movements with your head when using the device. Avoid walking with the device worn. In the event of a malfunction, stop using the device. If mounted correctly, the device must not come into contact with the user’s skin. Clean the device before use. When charging with adaptor, the socket-outlet shall be installed near the equipment and shall be easily accessible as the power supply plug allows you to disconnect the device from the mains supply. PRECAUTIONS Before operating the device it is recommended to fully charge it, waiting for all green LEDs on the Control Unit to light indicating that it is fully charged. When not in use, store the device in its container. Pay attention to your posture during prolonged use of the device in combination with Univet loupes. ADVERSE EFFECTS No adverse effects detected. SUPPLY MODE This device is not supplied sterile. This is not a single use device.o. STORAGE AND/OR HANDLING Store the device at the temperatures and humidity indicated in the “Technical Specifications” section. When not in use, store the cleaned device in its original packaging, disconnecting the Control Unit from LED. MAINTENANCE Clean the device as described in the “cleaning instructions” section. Keep the original packaging required for return/maintenance shipment and contact your authorised dealer. Any eventual activity / maintenance operation of the device must be carried out only and exclusively by Univet authorized personnel. The device does not need preventive maintenance activities. TRAINING AND QUALIFICATIONS FOR USE None.
Storage and transportation condition Temperature
DISPOSAL INSTRUCTIONS In the event of disposal/demolishing, do not dispose of the device in the environment. Comply with the relevant national regulations on electronic devicesci.
Relative humidity Atmospheric pressure
DESCRIPTION OF THE COMPONENTS The list of components and spare parts are indicated in the documents provided along with the device. SYMBOLS Below is the symbols present on the device label (when applicable):
REGULATIONS / DIRECTIVES / STANDARDS Compliance: IEC EN 60601-1; IEC EN 60601-1-2; IEC EN 62471. Unless otherwise indicated, the standards are to be considered in the latest applicable revisions.
HEALTH RISKS No health risk detected.
TECHNICAL SPECIFICATIONS Recommended Power supply Power supply approved in accordance with IEC 60950-1 standard (SELV approved) or in accordance with IEC IEC 62368-1 standard (ES1 approved) or in accordance with IEC 60601-1 standard (MOOP approved). Input power supply ................................................................................... 100-240 V~ ; 50-60 Hz ; 350 mA ; Output Power Supply ............................................................................. 5 V 2 A Control Unit Battery type ............................................................................................. Li-Ion / 3,7 V 7000 mAh Charging time .......................................................................................... ≥ 5 h Run time ................................................................................................... approx. 9h ± 10% Radio Module WARRANTY See the instructions laid down by the warranty. Report any serious accidents involving the device to the manufacturer and the competent authority of the Member state in which the user and/or the patient resides.
In accordance with Regulation (EU) 2017/745 on medical devices
Manufacturer’s recommendations and declarations Electromagnetic emission
This product cannot be dissed of in unsorted municipal waste
Emissions test
Compliance
Electromagnetic environment - Guideline
Country of manufacture Date of manufacture
Medical Device MD
Manufacturer
Instructions for use
RF emissions according to CISPR 11 EN 55011
This device uses RF energy only for its internal operation. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
IT
Gruppo 1
Serial number
Batch number
Catalogue number
Caution
90 %
106 kPa
RF emissions according to CISPR 11
+50 °C
Atmospheric pressure limitation
Humidity limitation
Temperature limitation
Class B
The device is suitable for use in a Professional healthcare environment.
-10 °C
50 kPa
10 %
INTENDED USE The Univet LynxPro LED (Light Emitting Diode) system is a portable lighting device that, when worn by the operator, illuminates the visual field during work activities. The lighting system is an accessory intended to be used, in combination with a “magnifying system” medical device, to illuminate the area viewed by the user. Intended users: medical professionals. Intended patients: no limitation except as stated in the “contraindications” section. DEVICES THAT CAN BE USED TOGETHER The device can be comfortably attached to all Univet magnifying system models, thus providing an integrated vision system. CONTRAINDICATIONS The device is contraindicated in the event of: - Patients highly sensitive to light; - Applications requiring lighting stability that cannot be achieved with devices mounted on the user’s head.
Harmonic emissions IEC 61000-3-2
Not applicable
RF Power ................................................................................................... 9.9 dBm EIRP Operating Frequency Band ................ .................................................... 2402-2480 MHz LED Colour temperature ................................................................................ 5700 K Maximum brightness ............................................................................. 50000 lux
The device is solely battery powered.
Voltage fluctuations / flicker emissions IEC 61000-3-3
Not applicable
Risk Group 2 CAUTION: Possibly hazardous optical radiation is emitted from this product. Do not stare at operating lamp. May be harmful to the eyes. Product tested against IEC 62471
Further documentation on electromagnetic compatibility (EMC) is available at the manufacturer web site. For languages not included in these use instructions, please see the following link: www.univetloupes.com/instructions
Univet Loupes Spa – Via G.Prati 87, 25086, Rezzato (BS) Italy - www.univetloupes.com Email: info@univetloupes.com - Telephone number: +39 030 2499411
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