ExamVision 20789 Manuel utilisateur
Instruction For Use
Total Pure/Intense LED
2
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 ........................................................................................3
Getting Started ...................................................................................4
Cleaning and disinfection....................................................................6
Cautions ..............................................................................................7
Safety Notice.......................................................................................8
More info ............................................................................................9
Technical Description........................................................................12
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.
ExamVision headlamps are to be used by Health Care Professionals
only, such as dentists, hygienists, doctors, surgeons, and clinicians
and are not intended to come into contact with patients.
Total LED comes in two versions: Pure and Intense. They should only
be used with ExamVision Light system control units and with original
ExamVision lamp cables.
To achieve the optimum result from your new light system, please
follow all instructions and videos carefully. If in doubt, please ask
your local ExamVision dealer for assistance.
Total LED has no defined Essential Performance. Temporary
degradation of performance can occur due to electromagnetic
disturbances. If this occurs turn the lamp unit off and on again.
4
Getting Started
Mounting the
framepart to the loupe
Use two screws (included) to attach the framepart to the loupes as
shown above. Tip: remove the loupe nosepad for easier access.
Recommended tool (not included): Philips PH00 screwdriver
Attach
ing Total LED to the loupe
Attach the lamp to
the framepart.
Connect the USB-C
connector to the lamp unit.
Fix the cable on
the right or left temple.
Connect the USB-C connector to
the Control Unit.
Follow your ExamVision Control Unit IFU to activate your Total LED.
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
onto the lamp unit with the
screw
facing upwards.
Tighten the pinol screw to fix the
Curing filter in place using the hex
key (included).
If the filter parts are separated,
slide the Curing filter into the
Curing filter ring.
Ensure curing filter is attached
securely and cannot be pulled off
before use.
6
Using
the curing filter
To activate:
Flip Curing filter down
To deactivate:
Flip Curing filter up
Cleaning and disinfection
Your Total lamp should be cleaned and disinfected before and after
each use.
1. Clean the product surface with a clean, soft, dampened cloth.
a. Ensure any physical residues (e.g. blood/tissue) are
removed from the surface.
b. Ensure all connections are free of dust.
2. Wipe the surface of the product with an alcohol-free
disinfection* wipe, taking care not to allow fluid into the USB-C
port.
CAUTION
•To ensure correct disinfection, follow the specific instructions on
the disinfection product.
•Do NOT use alcohol-based products, ultrasonic cleaners,
autoclave, UV disinfections methods or other chemical
disinfection, this will damage the product.
•Excessive liquids in the USB port can damage the product.
*Ammonium chloride <1% product similar to “Bossklein – Alcohol
free surface disinfection wipes”.
7
Cautions
This LED device has a very powerful light. Do not look directly into
the light, and do not point it into the eyes of other people.
To obtain an optimal lifetime of your product, always handle the
device with care. 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. Clean off any splashes
immediately to avoid damaging your unit. See section 5 for correct
cleaning and disinfection procedure.
Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of Total Lamp, including cables
specified by the manufacturer. Otherwise, degradation of
performance of this equipment could result.
Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Do not attempt to repair or modify your ExamVision product
yourself. Should the device become damaged or not work properly,
contact your ExamVision dealer for assistance.
8
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
product.
9
More info
Spare part list
Description
ExamVision
catalogue no.
Lamp Cable 1,3m USB-C 45/USB-C 45
20872
Total Lamp Curing filter
20871
Connect v3 Frame part
20795
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
Keep dry
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
Humidity range
Atmospheric pressure range
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3
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