ExamVision 20789 Instructions For Use Manual

Total pure/intense led

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Instruction For Use

Total Pure/Intense LED

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Summary of Contents for ExamVision 20789

Page 1 Instruction For Use Total Pure/Intense LED...
Page 2: Table Of Contents
Model overview This Instruction for Use (IFU) is valid for ExamVision Light system headlamp models: ☐ 20789 Total Pure LED (5000 K) GTIN: (01) 05744000230016 ☐ 20790 Total Intense LED (6500 K) GTIN: (01) 05744000230023 Indhold Model overview .................. 2 Introduction ..................
Page 3: Introduction
Total LED is a headlamp in the ExamVision light system. ExamVision headlamps are passive LED lamp units to be mounted onto ExamVision loupes, and to be powered by an ExamVision light System control unit. The ExamVision Light System is intended to illuminate the magnified working area of ExamVision loupes, for Health Care Professionals while performing medical procedures.
Page 4: Getting Started
Attach the lamp to Connect the USB-C the framepart. connector to the lamp unit. Fix the cable on Connect the USB-C connector to the right or left temple. the Control Unit. Follow your ExamVision Control Unit IFU to activate your Total LED.
Page 5 Aligning the light spot Up/Down adjustment Side to side adjustment Mounting the Curing filter on Total LED Slide the Curing filter ring gently Tighten the pinol screw to fix the onto the lamp unit with the screw Curing filter in place using the hex facing upwards.
Page 6: Cleaning And Disinfection
Using the curing filter To activate: To deactivate: Flip Curing filter down Flip Curing filter up Cleaning and disinfection Your Total lamp should be cleaned and disinfected before and after each use. Clean the product surface with a clean, soft, dampened cloth. a.
Page 7: Cautions
Do not expose the product to hot, cold, or moist conditions that exceed those specified in the technical description, as this can damage the product. Do not short-circuit your ExamVision product. Your ExamVision Light system headlamp and Control unit are not designed to be immersed in water.
Page 8: Safety Notice
Safety Notice ExamVision strongly encourage health professionals to stay in compliance with current regulations and notify any unintended incidents to your local dealer or directly to the manufacturer ExamVision. We continuously strive to incorporate usage experience into corrective action for the benefit of health professional users of the...
Page 9: More Info
Symbol explanation Manufacturer ExamVision ApS, Industrivej 11 8305 Samsø Denmark www.examvision.com Catalogue number 20789 Total Pure LED (5000 K) 20790 Total Intense LED (6500 K) Non-sterile Do not use if package is damaged Fragile, Handle with care Keep away from sunlight...
Page 10 Read the instructions for use before using the product: https://examvision.com/support/ Caution Medical device Unique device identifier GS1: GTIN + Serial No. For indoor use only MR Unsafe WEEE - DIRECTIVE 2012/19/EU Disposal product as electronic waste CE Mark Storage temperature range...
Page 11 Warranty All ExamVision products come with a comprehensive warranty as standard. 20789 Total Pure LED (5000 K) is covered by a 3-year manufacturer warranty. 20790 Total Intense LED (6500 K) is covered by a 3-year manufacturer warranty. This warranty covers all manufacturing defects which might manifest within the warranty term.
Page 12: Technical Description
Technical Description Technical specification Material Aluminium Compatible Control unit 20791 PowerGo Connection type USB-C Spot size at WD 40 cm 70 mm uniform light spot Weight with frame part 18 g Light colour Total Pure: 5000 K Total Intense: 6500 K Maximum light intensity at 25 cm Total Pure: 21,900 Lux Total Intense: 51,500 Lux...
Page 13 LED Chip Total Intense LED Osram GW CSSRM3.PM 6500K Maximum continuous input rating 3 VDC 450 mA Warranty 3 years Operation temperature range 0 °C - 25 °C Storage temperature range -20 °C - 60 °C Humidity range 0 %rh - 60 %rh Atmospheric pressure range 70 kPa –...
Page 14 Technical information The manufacturer declares that this product is compliant with the following regulations, standards, and certifications: MDR EU 2017/745 European medical device regulation IEC 60601-1:2005 + A1:2012 + A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014 + A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -...
Page 15 Technical Data Phenomenon Test method Emission class and group/ Immunity test level Conducted RF CISPR 11 emissions Radiated RF CISPR 11 Class A Group 1 emissions NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
Page 16 Phenomenon Test method Emission class and group/ Immunity test level Electrostatic IEC 61000-4-2 ±8 kV Contact discharge immunity ±2, ±4, ±8, ±15 Air Radiated RF IEC 61000-4-3 80 MHz – 2.7 GHz, 10 V/m, electromagne 80% AM 1 kHz tic field immunity Immunity to IEC 61000-4-3...
Page 17 Phenomenon Test method Emission class and group/ Immunity test level 930 MHz, 28 V/m, 18 Hz PM (50 % duty cycle square wave) 1720 MHz, 28/ V/m, 217 Hz PM (50 % duty cycle square wave) 1845 MHz, 28 V/m, 217 Hz PM (50 % duty cycle square wave) 1970 MHz, 28 V/m, 217 Hz...
Page 18 Phenomenon Test method Emission class and group/ Immunity test level Immunity to IEC 61000-4-6 conducted disturbances induced by RF fields Power IEC 61000-4-8 frequency magnetic field immunity Voltage dips, IEC 61000-4-11 short interruptions and voltage variations immunity Electrical ISO 7637-2 transient conduction along supply...

This manual is also suitable for:

20790 05744000230016 05744000230023