OPTICLUX 10-1 LED Magnifier Light with Double Arm Installation Guide
- September 7, 2024
- OPTICLUX
Table of Contents
10-1 LED Magnifier Light with Double Arm
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Specifications:
- Product Name: OPTICLUX
- Model: 10-1 C T1 / 10-2 C T1 / 10-1 P TX / 10-2 P TX
- Intended Use: Laboratory or quality control
- Lifetime: 10 years
Product Usage Instructions:
1. Safety Instructions:
Ensure to follow these safety instructions while using the
OPTICLUX:
-
Never place additional loads on the light head or arm.
-
Avoid covering the light with cloth while in operation.
-
Keep ventilation openings clear during operation.
-
Avoid operating near external heat sources exceeding maximum
ambient temperature. -
Use only in intended environmental conditions.
-
Do not look into the UV rays (Wood light version only).
-
Cover the magnifier after use to prevent fire or burns.
-
Advise patients to keep eyes closed during UV light exposure
(Wood light version only).
2. Specific Mounting Instructions:
Mount the OPTICLUX according to the specific instructions for
your model:
-
OPTICLUX 10-1 C T1 / OPTICLUX 10-2 C T1:
Ceiling mounting requires appropriate material and must be fixed
securely. -
OPTICLUX 10-1 P TX / OPTICLUX 10-2 P TX:
Professional installation is needed for wall mounting. Use suitable
mounting material.
3. Assembly Instructions:
Follow these steps for assembly:
-
Load Data:
- Bending Moment MB: 25Nm
- Vertical Weight FG: 90N
-
Attaching the Ceiling Bracket:
-
Assembly must be done by qualified personnel only.
-
Ceiling must be solid concrete for a secure hold.
-
An external all-pole switch is required for mains
separation. -
Voltage supply needs overcurrent release for safety.
-
FAQ:
Q: Can I use the OPTICLUX in any environmental condition?
A: No, the OPTICLUX must only be used in the
specific environmental conditions it is intended for.
Q: How often should I replace the light in OPTICLUX?
A: The lamp is intended for a lifetime of 10
years, so it does not require frequent replacement.
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ENG
1 SAFETY INSTRUCTIONS
1.1 Intended use
The light Dmed® OPTICLUX is an examination light. Its intended use is to
illuminate the body of the patient to support diagnosis or treatment. An
interruption of the diagnosis or treatment caused by a light failure is always
possible without posing any risk for the patient. The light cannot be used in
operating rooms. Moreover, Dmed® OPTICLUX can also be used in the
laboratory or in quality control.
1.2 User profiles
Medical professional A medical professional is any person who has completed
medical training and is working in his or her professional field. Cleaning
professional A cleaning professional is trained in national and jobrelated
hygiene regulations. Electrician An electrician is trained in the fields of
electronics and electrical engineering and is familiar with the relevant
standards and regulations. Qualified professional A qualified professional is
capable of mounting and dismounting the light thanks to professional training,
knowledge and experience and knowledge of the regulations.
1.3 Safety instructions
Operation by a medical professional The instructions form part of the product.
They must
be stored and made accessible to all subsequent users. Any work on the light
(including repairs) must be carried out by qualified electricians only.
Mounting must be performed by a qualified professional only. The light must
not be altered or manipulated in any way. Only approved original parts must be
used. Any use other than the intended use with original parts may give rise to
other technical values and life-threatening danger. Operation in potentially
explosive areas is prohibited. The light power supply is a potential ignition
source. The light must only be operated in dry, dust-free rooms. The light
must not be left switched on without supervision. For lights in protection
class I, it is essential for the earthing conductor to be connected to the
light housing. Do not use any light that is damaged. Defective cables are also
potential hazards. Do not place the cable close to any heat source or on sharp
edges. Damage to the eyes. Never look directly into the light source. Replace
any glass that is damaged before operating the light again. In order to
prevent electric shocks, only connect the light to a power supply with an
earth conductor (only C-version). Luminaires which are equipped with a
hospital grade plug (UL 817, only US- and Canada version), the earth connector
is used as a functional earth within the luminaire.
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Never place additional loads on the light head or the arm.
The light must not be covered by a cloth or any similar item while it is in
operation.
The ventilation openings (where they exist) must be free whenever the light is
in operation.
The light must not be operated near to external heat sources that exceed the
maximum ambient temperature of the light.
The light must not be used in environmental conditions other than those for
which it is intended.
The light must only be used for the intended use described in this document.
The manufacturer cannot be held responsible for any injury or damage that is
caused as a result of any use other than the intended use or of any failure to
comply with safety instructions and warnings.
Do not look into the UV rays (Wood light version only).
After use, always cover the magnifier with the magnifier cover (danger of fire
or burns).
During an examination in which the eyes may come into contact with UV light
(Wood light version only), the user must advise the patient to keep his or her
eyes closed.
The lamp is intended for a lifetime of 10 years
1.4 Warning levels
DANGER
Indication of hazards that can lead to death or serious injury if measures are
disregarded.
WARNING
Indication of hazards that can lead to injury if measures are disregarded.
CAUTION
Indication of hazards that can lead to damage to property if measures are
disregarded.
1.5 Specific mounting instructions
OPTICLUX 10-1 C T1 / OPTICLUX 10-2 C T1
Mounting material is not included. The ceiling mounting must only be fixed to
ceilings
that have a concrete stability class B25 (C20/25) or higher. Solid ceiling
reinforcement parts must not come into contact with the ceiling mounting. If
there is any doubt, an authorized professional must confirm that mounting is
possible on the mounting base being used. Drilling must be done by specialists
in compliance with the drilling tolerances for the reinforcement anchor that
have been approved by the manufacturer. Screws must be tightened carefully
using a torque key that complies with the instructions of the reinforcement
anchor manufacturer.
OPTICLUX 10-1 P TX / OPTICLUX 10-2 P TX
Mounting material is not included. When using the accessory “wall mount”, the
installation must be undertaken by a professional. The wall must guarantee a
firm hold. Use only mounting material which is suitable for the
corresponding substrate.
2 SCOPE OF SUPPLY
2.1 OPTICLUX 10-1 C T1 / OPTICLUX 10-2 C T1
A
C
B
F
D
E
A:
1x ceiling bracket (inner surface of B)
B:
1x ceiling cover
C:
1x end ring
D:
1x ceiling tube incl. cable
E:
1x light with adaptor (pre-assembled)
F:
1x loupe cap
ENG 2.2 OPTICLUX 10-1 P TX / OPTICLUX 10-2 P TX
1x light
1x power cable
1x loupe cap
3
ASSEMBLY of OPTICLUX 10-1 C T1 /
OPTICLUX 10-2 C T1
3.1 Load data
Bending moment MB
25Nm
Vertical weight FG
90N
3.2 Attaching the ceiling bracket
DANGER
Assembly by qualified personnel Assembly must be carried out by qualified
personnel only. Lack of appropriate knowledge could be life-threatening.
DANGER
Life-threatening danger from falling light. The ceiling must be made of solid
concrete to
guarantee a secure hold.
DANGER
Electric shocks are life threatening It must be possible to separate the light
from the
mains by an external all-pole switch (not included).
DANGER
Electric shocks are life-threatening Voltage supply from the power connection
must be
protected on all poles by means of an overcurrent release (according to
national installation requirements; it is not included in the scope of
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ENG
supply).
Pay attention to the minimum distance of the ceiling tube!
Saw ceiling tube to the desired length at the top end using a metal saw and
deburr.
Risk of injury from falling parts Mounting must be performed by two people.
CAUTION Use protective equipment in line with the tool manufacturer’s
instructions
Remove fastening screw.
Insert ceiling tube 1 into ceiling bracket 2 and drill with d= 9mm 3. Use the
existing hole in the ceiling bearing as a guide.
Make 4 opposited drill hole markings (Ø13mm), note the position of the Ø60mm
drill hole for electrical connections
Drill the bore holes, then blow them out using bellows DANGER
Risk of injury from falling light The ceiling must be made of solid concrete
to
guarantee a secure hold. Use suitable ceiling anchors.
Disassemble the securing element from the ceiling tube (Allen wrench is
enclosed; do not lose the threated pin!)
Insert the cable (with loose ends first) and pull up to the stop
Check clearances
DANGER Risk of injury from falling parts The ceiling bracket must be secured
to the
fastening material, which must be suitable for the corresponding ceiling
condition.
DANGER
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Pull the light cable of the ceiling tube through the
light mount. Insert ceiling tube into light mount Secure using the M8 safety
screw and nut 1
Hold the ceiling bracket against the ceiling and strike the ceiling anchor
with a hammer
Tighten fastening in line with manufacturer’s data
ENG
Push cover and end ring over the ceiling bracket and tighten them (0.5Nm)
3.3 Assemble the light on ceiling tube
WARNING
The light will fall if fastening is done incorrectly The securing element must
be screwed in fully and
correctly.
Tighten M8 safety screw and nut 1 (20 Nm / 14.75 lbf ft)
Tighten all 4 threaded pins 2 (5 Nm / 3.68 lbf ft) DANGER
Mortal danger from electric shock Disconnect from the power supply and secure
against unintended switching on before starting work on the power connection.
Make power connection
Connect the secondary cable to the connection point
Pay attention to the polarity: + = black Connect the brown cable = white
Connect the blue cable
Insert the light and the adapter 1 into the ceiling tube 2
Insert securing element with threated pin 3 and screw in to the stop
Loosen by one quarter-turn to ensure the operation of the turnover axis
4 ASSEMBLY of OPTICLUX 10-1 P TX / OPTICLUX 10-2 P TX
4.1 Load data
Bending moment MB
25Nm
Vertical weight FG
20N
4.2 Assembly
The lights are equipped with an adapter pin. The light must be positioned in
one of the accessories described in chapter 9.
5 OPERATION
5.1 OPTICLUX 10-1 C T1 / OPTICLUX 10-2 C T1
DANGER
Electric shocks are life-threatening
Only connect to a mains power supply with a protective conductor
5.2 OPTICLUX 10-1 C T1 / OPTICLUX 10-2 C T1 / OPTICLUX 10-1 P TX / OPTICLUX
10-2 P TX
DANGER
Electric shocks are life-threatening
Do not insert any power cable that is damaged. If there is any sign of damage
to the power cable,
replace it immediately with a new one. The connection voltage and frequency
must match
the data on the type plate.
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ENG
WARNING Risk of eye damage Never look directly into the beam of light.
Insert power cable Connect the cable to the mains Perform a function test
before every use:
All LED’s in the light cone must illuminate.
5.3 Transport position
Only transport the light in this position.
OPTICLUX 10-1 C T1 / OPTICLUX 10-1 P TX
6 CLEANING
DANGER
Electric shocks are life-threatening
Switch off the power and secure against unintended switching on before
cleaning.
CAUTION
Damage to property caused by incorrect cleaning
Use only detergents that will not affect the functional capability of the
light.
No cleaning agents containing solvents, chlorine or abrasive products must be
used. Those agents can cause damage to the plastic parts.
The cleaning agents must be suitable and approved for plastics like PC, PMMA,
PA and ABS.
Concentrated disinfectants may damage the light. Pay attention to the
specifications from the data
sheet of the agent for concentration and effectiveness time. Unsuitable cloths
can cause scratches.
CAUTION
Dirt decreases luminosity
Clean regularly to keep the screen clean. Cleaing only by wiping is permitted.
Switch the LED module on/off Press and hold the button for dimming
OPTICLUX 10-2 C T1 / OPTICLUX 10-2 P TX
A B
Clean the PMMA screen with a non-abrasive cleaning cloth and a suitable
cleaning agent.
CAUTION
To minimize the risk of disease transmission, in addition to complying with
this instruction for use, you must also comply with the applicable
occupational health and safety regulations and the requirements of national
bodies with responsibilities for hygiene and disinfection.
A: Switch the LED module on/off A: Press and hold the button for dimming B:
Switch to Woodlight
20
7 SAFETY INSPECTIONS
DANGER
Electric shocks are life-threatening Remove the mains plug from the mains. The
connecting cable must be checked for
damage at least once per year.
CAUTION Maintenance and repairs must only be carried out
by qualified electricians. The corresponding user profile is described in
Chapter 1, Safety instructions
8 DISMANTLING
DANGER
Electric shocks are life-threatening Disconnect from the power supply and
secure
against unintended switching on before disassembling.
8.1 Disposal
Do not dispose of the light in household refuse. Dispose of the light at a
disposal point in accordance with local regulations or take them to a dealer
that provides an appropriate disposal service. Cut off the cable directly on
the housing. The products listed above are more than 95% recyclable. The
lights have been constructed to be compatible with recycling so that a high
proportion of the materials used in these products can be recycled or
converted into energy after their end of service life. They contain no
materials that are dangerous or that need to be monitored.
9 ACCESSORIES
Table clamp (Art. No.: D14.228.000 – black)
Rail clamp (Art. No.: D13.269.000)
ENG
Wall bracket (Art. No.: D13.231.000 – pure white) Roller stand (Art. No.: D15.595.000)
10 ADDITIONAL INSTRUCTIONS
The light itself is maintenance-free.
You can obtain additional documents about this product from the manufacturer
upon request. These lights do not affect any other devices. To save energy,
the light should only be switched on when actually needed.
Universal mount (Art. No.: D13.430.000 – pure white)
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ENG
11 TROUBLESHOOTING
Fault
Possible cause
Troubleshooting
The light does not light
Contact problem
Switch on again
The light does not light
No mains voltage
Check mains voltage, check all connections
The light does not light
LED module defective Contact manufacturer service
User profiles All Electrician
By manufacturer service only
12 TECHNICAL DATA
Electrical data: Rated input voltage Frequency range Power consumption Input
current Power factor Power supply secondary side
Photometric values: Central illuminance Ev at 15 cm (0.5 feet) distance (380
780nm, 6500K) Central irradiance Ee at 15 cm (0.5 feet) distance (315 400nm,
Wood light) Light field diameter d10 at 15 cm (0.5 feet) distance Colour
temperature Colour rendering index Ra Colour rendering index R9 Total
irradiance Ee at maximum intensity Ratio irradiance Ee to illuminance Ec
100 – 240VAC 50/60 Hz 10.8-12W (11.4-14.2 VA) 0.059-0.116 A 0.84 0.93 24VDC
6`000 lx 7,6 W/m2 Ø = 56 cm (1.9″) 6000 6500 K >93 >90 <25 W/m2 4
mW/m2/lx -10% / +20% tolerance
Ambient conditions for transport, storage and operation: Ambient temperature
(storage and transport) Ambient temperature (operation) Relative humidity
(non-condensing) (storage and transport) Relative humidity (non-condensing)
(operation)
Weight: OPTICLUX 10-1 C T1 / OPTICLUX 10-2 C T1 OPTICLUX 10-1 P TX / OPTICLUX
10-2 P TX
Mode of operation: Mode of operation
Classification: OPTICLUX 10-1 C T1 / OPTICLUX 10-2 C T1 OPTICLUX 10-1 P TX /
OPTICLUX 10-2 P TX Degree of protection according to IEC 60529 Classification
according to directive 93/42/EWG annex IX (medical device class) U.S. FDA
Device Class
Electrical safety test and EMC according to:
Blue light hazard according to EN/IEC 62471 Service life of the light source:
Service life LED
-20°C to +70°C (-4°F to +158°F) +10°C to +35°C (+50°F to +95°F) max. 90% max. 75%
9kg (19.8 lb) 2kg (4.4 lb)
Continuous operation
Protection class I (C-version) Protection class II (P-version) IP 20 Class I
Class I IEC 60601-1; IEC 60601-2-41 IEC 60601-1-2 OPTICLUX 10-1:RG 0 /OPTICLUX
10-2: RG 1
50`000h L80/B10
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ENG
13 ELECTROMAGNETIC COMPATIBILITY (EMC)
Electromagnetic interference guidelines
The medical device is intended for operation in an electromagnetic environment such as the one specified below. The user must
ensure that it is operated in such an environment.
Emissions
In accordance Electromagnetic environment
High-frequency emissions (CISPR 11)
Group 1
The medical device uses HF energy exclusively for its internal function. This means that its HF emissions are very low, and it is unlikely that adjacent electronic devices will receive any interference.
High-frequency emissions (CISPR 11)
Professional Healthcare
The medical device is intended for use in all facilities, including residential buildings and facilities that are directly connected (without a transformer) to the same low voltage network as residential buildings.
Emissions from harmonics
Class A
(IEC 61000-3-2)
Emissions from voltage
Compliance
fluctuations/flicker (IEC 61000-3-3)
Electromagnetic interference resistance guidelines
The medical device is intended for operation in an electromagnetic environment such as the one specified below. The user must
ensure that it is operated in such an environment.
Interference resistance to
IEC 60601-1-2 testing
Conformity level of
Electromagnetic environment
level
the medical device
Electrostatic discharge (ESD) (IEC 61000-4-2)
Contact discharge: ± 8 kV Air discharge: ± 15 kV
± 8 kV ± 15 kV
Floors made of timber, concrete or ceramics tiles are preferred. Where synthetic floor covering is used, the relative humidity should be at least 30%.
Fast transients/electrical disturbance variables/bursts (IEC 61000-4-4)
Power supply cables: ± 2 kV Longer input and output cables: ± 1 kV
± 2 kV Not applicable
The quality of the mains power supply should match that of a typical business or hospital environment.
Surge voltages/surges (IEC 61000-4-5)
Line-Line: ±1 kV ±2 kV phase-to-earth voltage
±1 kV ±2 kV
The quality of the mains power supply should match that of a typical business or hospital environment.
Magnetic field in the power supply frequency (50/60 Hz) (IEC 61000-4-8)
Voltage dips and short interruptions to the power voltage (IEC 61000-4-11)
30 A/m
Voltage Dips: 100% / 0,5 periode at 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315° 30% /25/30 period at 0° 100% / 1 Periode bei 0°
100 A/m
0 % UT; 0.5 cycle 40% UT; 10 cycles 70% UT; 25 cycles 0 % UT; 250 cycles
In proximity of this medical device, do not operate devices with unusually
strong network-frequency magnetic fields (transformer stations etc.).
The supply voltage quality should be that of a typical business or hospital
environment. If the user requires continued function during any interruption
of the energy supply system, we recommend that the medical device be powered
by an uninterrupted power supply or a battery.
Radiated HF disturbance variable 3 V/m
10 V/m
Recommended minimum distance of portable and
(IEC 61000-4-3)
80 MHz – 2.5 GHz
80 MHz – 2.7 GHz
mobile radio devices of PEIRP radiated power to the medical device, including its cables: d = 0.35P
Conducted HF disturbance
3 Vrms-value
10 Vrms-value
Recommended minimum distance of portable and
values (IEC 61000-4-6)
150 kHz – 80 MHz
150 kHz – 80 MHz
mobile radio devices of PEIRP radiated power to the
medical device, including its cables: 80 MHz 800 MHz: d = 0.35P 800 MHz – 2.5 GHz: d = 0.7P
d = recommended safe distance [m], P = Rated power of the sender [ W ]. Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with:
Recommended safe distances from portable and mobile HF communications equipment
Rated Power of the sender [ W ]
150 kHz – 800 MHz
800 MHz – 2.5 GHz
0.01
0.035 m (0.11 ft)
0.07 m (0.23 ft)
0.1
0.11 m (0.36 ft)
0.22 m (0.72 ft)
1
0.35 m (1.15 ft)
0.7 m (2.30 ft)
10
1.11 m (3.64 ft)
2.21 m (7.25 ft)
50
2.47 m (8.10 ft)
4.95 m (16.24 ft)
100
3.5 m (11.48 ft)
7 m (22.97 ft)
23
References
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