ExamVision 20789 User manual

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

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.
Please note, our warranty does not cover defects caused by normal
wear or tear, misuse, neglect, accidental damage, modification,
shipping in non-original packaging, or faults due to improper fitting,
maintenance, service, cleaning or disinfection procedures.
This warranty is also void if the product is not used according to the
Instruction for use.
Additional information:
Detachable cables and curing filters are considered replaceable parts
that can be expected to wear.
Replaceable parts are covered for manufacturing defects for one
year.
In the event of malfunction, please return the device to your
ExamVision dealer for repair.
For more information about ExamVision Warranty please see
Examvision.com/warranty.

12
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
Maximum light intensity at 35 cm Total Pure: 11,300 Lux
Total Intense: 25,400 Lux
Colour rendering index Total Pure: >90 CRI
Total Intense: >70 CRI
LED Chip Total Pure LED Samsung LH351D 5000K

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 – 106 kPa
Product information Over-current protection,
Over-voltage protection

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 -
Collateral Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6:2010 + A1:2013 + A2:2020
-Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance -
Collateral standard: Usability
IEC 62471:2006
-Photobiological safety of lamps and lamp systems
IECEE CB Scheme
-Certificate for medical Equipment

15
Technical Data
Phenomenon
Test method
Emission class and group/
Immunity test level
Conducted RF
emissions
CISPR 11
N/A
Radiated RF
emissions
CISPR 11
Class A Group 1
NOTE The EMISSIONS
characteristics of this
equipment make it suitable
for use in industrial areas
and hospitals (CISPR 11 class
A). If it is used in a
residential ENVIRONMENT (for
which CISPR 11 class B is
normally required) this
equipment might not offer
adequate protection to
radio-frequency
communication services.
The user might need to take
mitigation measures, such as
relocating or re-orienting
the equipment.
Harmonic
current
emissions
IEC 61000-3-2
N/A
Voltage
fluctuations
and flicker
IEC 61000-3-3
N/A

16
Phenomenon
Test method
Emission class and group/
Immunity test level
Electrostatic
discharge
immunity
IEC 61000-4-2
±8 kV Contact
±2, ±4, ±8, ±15 Air
Radiated RF
electromagne
tic field
immunity
IEC 61000-4-3
80 MHz – 2.7 GHz, 10 V/m,
80% AM 1 kHz
Immunity to
proximity
fields from RF
wireless
communicati
on equipment
IEC 61000-4-3
385 MHz, 27 V/m, 18 Hz PM
(50 % duty cycle square
wave)
450 MHz, 28 V/m, FM +/- 5
kHz dev., 1 kHz sine
710 MHz, 9 V/m, 217 Hz PM
(50 % duty cycle square
wave)
745 MHz, 9 V/m, 217 Hz PM
(50 % duty cycle square
wave)
780 MHz, 9 V/m, 217 Hz PM
(50 % duty cycle square
wave)
810 MHz, 28 V/m, 18 Hz PM
(50 % duty cycle square
wave)
870 MHz, 28 V/m, 18 Hz PM
(50 % duty cycle square
wave)

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
PM (50 % duty cycle square
wave)
2450 MHz, 28 V/m, 217 Hz
PM (50 % duty cycle square
wave)
5240 MHz, 9 V/m, 217 Hz
PM (50 % duty cycle square
wave)
5500 MHz, 9 V/m, 217 Hz
PM (50 % duty cycle square
wave)
5785 MHz, 9 V/m, 217 Hz
PM (50 % duty cycle square
wave)
Electrical fast
transient/bur
st immunity
IEC 61000-4-4
N/A
Surge
immunity
IEC 61000-4-5
N/A

18
Phenomenon
Test method
Emission class and group/
Immunity test level
Immunity to
conducted
disturbances
induced by RF
fields
IEC 61000-4-6
N/A
Power
frequency
magnetic
field
immunity
IEC 61000-4-8
N/A
Voltage dips,
short
interruptions
and voltage
variations
immunity
IEC 61000-4-11
N/A
Electrical
transient
conduction
along supply
lines
ISO 7637-2
N/A
Proximity
magnetic
fields
IEC 61000-4-39
N/A

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