Installation and operating instructions ENG

Installation and operating instructions ENG
Installation and operating instructions ENG
CLED23
Examination light
SYMBOLE; SYMBOLS
The warning symbols indicate all instructions that are important for safety. Failure to comply with them can lead to injury,
damage to the luminaire or the equipment. In combination with the following signal words the warning symbols means:
DANGER
Can lead to death or serious injury
WARNING
Can lead to injury
Comply with operating Instructions
CE conformity mark
Protective earth, protection class I device
Protection class II device
Neutral conductor/return conductor for the electrical current
Live conductor
Storage humidity
Storage temperature
Disposal
Manufacturer
Date of manufacture
Item number
Batch code
Serial Number
2
VARIANTS
CLED23 T1C
CLED23 TXPPS
Contents
1
4
5
6
7
8
9
10
11
12
13
SAFETY INSTRUCTIONS ....................................................................................................................................... 4
1.1
Intended use ................................................................................................................................................. 4
1.2
User profiles ................................................................................................................................................. 4
1.3
Safety instructions ........................................................................................................................................ 4
1.4
Warning levels .............................................................................................................................................. 4
1.5
Specific mounting instructions ...................................................................................................................... 4
2
SCOPE OF SUPPLY .................................................................................................................................... 5
2.1
CLED23 T1C ................................................................................................................................................ 5
2.2
CLED23 TXPPS ........................................................................................................................................... 5
3
ASSEMBLY CLED23 T1C ............................................................................................................................ 5
3.1
Load data...................................................................................................................................................... 5
3.2
Attach ceiling bracket.................................................................................................................................... 5
3.3 Assemble the luminaire on ceiling tube ............................................................................................................. 7
ASSEMBLY CLED23 TXPPS .................................................................................................................................. 7
4.1
Load data...................................................................................................................................................... 7
4.2
Assembly ...................................................................................................................................................... 7
OPERATION ............................................................................................................................................................ 7
5.1
CLED23 T1C ................................................................................................................................................ 7
5.2
CLED23 ........................................................................................................................................................ 7
5.2
Transport position ......................................................................................................................................... 8
DISINFECTION CLEANING .................................................................................................................................... 8
SAFETY INSPECTIONS .......................................................................................................................................... 8
DEMOUNTING ........................................................................................................................................................ 9
8.1
Disposal ........................................................................................................................................................ 9
ACCESSORIES ....................................................................................................................................................... 9
ADDITIONAL INSTRUCTIONS................................................................................................................................ 9
TROUBLESHOOTING ........................................................................................................................................... 10
TECHNICAL DATA ................................................................................................................................................ 10
ELECTROMAGNETIC COMPATIBILITY (EMC) .................................................................................................... 12
3
ENG
1
SAFETY INSTRUCTIONS
1.1
Intended use
med®
The luminaire D
CLED23 is an examination
luminaire. 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 a risk for the
patient. The luminaire can not be used in operating
rooms.
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 luminaire thanks to professional
training, knowledge and experience and knowledge of
the regulations.

1.4
The luminaire 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 luminaire is in operation.
The luminaire must not be operated near to
external heat sources that exceed the maximum
ambient temperature of the luminaire.
The luminaire must not be used in environmental
conditions other than those for which it is intended.
The luminaire 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.
It’s recommended to protect the luminaire with an
additional earth leakage circuit breaker.
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
1.3













4
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 luminaire (including repairs) must
be carried out by qualified electricians only.
Mounting must be performed by a qualified
professional only.
The luminaire 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 luminaire power supply is a
potential ignition source.
The luminaire must only be operated in dry, dustfree rooms.
The luminaire must not be left switched on without
supervision.
For luminaires in protection class I, it is essential
for the earthing conductor to be connected to the
luminaire housing.
Do not use any luminaire 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 luminaire again.
In order to prevent electric shocks, only connect
the luminaire to a power supply with an earth
conductor (only C-version).
Never place additional loads on the luminaire head
or the arm.
Indication of hazards that can lead to damage to
property if measures are disregarded.
1.5
Specific mounting instructions
CLED23 T1C





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.
Borings must be made by specialists in compliance
with the boring 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.
CLED23 TXPPS




Mounting material is not included.
When using the accessory "wall mount", the
installation must be done by a professional.
The wall must ensure a firm hold.
Use only mounting material which is suitable for
the corresponding substrate.
ENG
2
SCOPE OF SUPPLY
3
ASSEMBLY CLED23 T1C
2.1
CLED23 T1C
3.1
Load data
Bending moment MB
25Nm
Vertical weight FG
90N
3.2
Attach 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 luminaire.
 The ceiling must be made of solid concrete to
guarantee a secure hold.
A:
B:
C:
D:
E:
1x ceiling bracket
1x ceiling cover
1x end ring
1x ceiling tube incl. cable
1x luminaire with adaptor (pre-assembled)
2.2
CLED23 TXPPS
DANGER
Electric shocks are life threatening





1x Luminaire
1x Power cable
The luminaire must be separated from the mains
by an external all-pole switch.
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.

Remove fastening screw.

Insert ceiling bracket 1 into ceiling bracket 2 and drill
with d= 9mm 3. Use the existing hole in the ceiling
bearing as a guide.
5
ENG

Make 4 opposited bore hole markings (Ø13mm),
consider the position of the Ø60mm bore for
electrical connections

Check clearances

Disassemble the securing element from the ceiling
tube (Allen wrench is enclosed, do not lose the
threaded pin!)

Insert the cable (with loose ends first) and pull up to
the stop

Pull the luminaire cable of the ceiling tube through
the luminaire mount.
Insert ceiling tube into luminaire mount
Secure using the M8 safety screw and nut 1
DANGER
Risk of injury from falling parts

The ceiling bracket must be secured to the
fastening material, that must be suitable for the
corresponding ceiling condition.
DANGER
Risk of injury from falling parts

Mounting must be performed by two people.


CAUTION
Use protective equipment in line with tool
manufacturer's instructions



Hold the ceiling bracket against the ceiling and strike
the ceiling anchor with a hammer
Tighten fastening in line with manufacturer's data
Drill the bore holes, then blow them out using
bellows
DANGER
Risk of injury from falling luminaire


The ceiling must be made of solid concrete to
guarantee a secure hold.
Use suitable ceiling anchors.


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

6
Disconnect or remove fuses before carrying out any
work on the power connection
ENG
4
ASSEMBLY CLED23 TXPPS
4.1
Load data
Bending moment MB
25Nm
Vertical weight FG
20N
4.2

Make power connection

Assembly
The luminaire are equipped with an adapter pin. The
luminaire must be positioned in one of the
accessories described in chapter 9.
5
OPERATION
5.1
CLED23 T1C
DANGER
Electric shocks are life-threatening


Connect the secondary cable to the conncection
point
Pay attention to the polarity: + = red = brown
– = blue

5.2
Only connect to a mains power supply with a
protective conductor
CLED23
DANGER
Electric shocks are life-threatening



Push cover and end ring over the ceiling bracket and
tighten them (0.5Nm)

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.
3.3 Assemble the luminaire on ceiling tube
WARNING
WARNING
The luminaire will fall if fastening is done incorrectly




Risk of eye damage

Never look directly into the beam of light.
The securing element must be screwed in completely
and correctly.



Insert power cable to the luminaire
Connect the cable with the mains
Perform a function test before every use:
All LED’s in the light cone must illuminate.

Switch the LED module on/off
Insert the luminaire and the adapter 1 into the ceiling
tube 2
Insert securing element with threaded pin 3 and
screw in to the stop
Loosen by one quarter-turn to ensure the function of
the turnover axis
7
ENG
CAUTION
Damage to property caused by incorrect cleaning



Set the desired colour temperature according to the
following table:

COLOUR
COL. TEMP.
RECOMMENDATION

blue
cold white
Ideal for identifying
individual vessels
for wound follow-up
treatment and small
procedures
Ideal for various types
of skin examinations

orange
warm white

Use only disinfectants that will not affect the
functional capability of the luminaire.
No cleaning agents containing alcohol, solvents,
chlorine or abrasive products must be used. Those
agents can cause damages in the plastic parts.
The cleaning and disinfection agents must be
suitable and approved for plastics like PC, PMMA,
PA and ABS.
Concentrated disinfectants may damage the cover.
Pay attention to the specifications from the data
sheet of the agent for concentration and residence
time.
Unsuitable cloths can cause scratches.
NOTE
Dirt decreases luminosity



5.2
Clean regularly to keep the screen clean.
Disinfection only by wiping is permitted.
Set the desired Illuminance in 25% dimmer steps
Transport position

Clean the PA screen with a not abrasive cleaning
cloth and a suitable cleaning agent.
CAUTION

6
Transport the luminaire only in this position.
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.
DISINFECTION CLEANING
DANGER
7
DANGER
Electric shocks are life-threatening

Remove the plug from the mains before the
disinfection cleaning.
SAFETY INSPECTIONS
Electric shocks are life-threatening


Remove the plug from the mains.
The connecting cable must be checked for
damage at least once per year.
NOTE


8
Maintenance and repairs must only be carried out
by qualified electricians.
The corresponding user profile is described in
Chapter 1, Safety instructions
ENG
8
DEMOUNTING
DANGER
Electric shocks are life-threatening

8.1
Remove the plug from the mains before
demounting.
Disposal
Do not dispose the luminaire in household
refuse. Dispose the luminaire 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 luminaires 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 the end of
service life. They contain no materials that
are dangerous or that need to be monitored.
9
ACCESSORIES
Description
Item code
16mm MOBILE BASE
HWSCAM14255
COOLVIEW WALL
BRACKET ASSEMBLY
CABW14271
Rail Mount Bkt 16mm
CABKTR16
1 Meter Medirail kit.
Boxed with endcaps
CABKTRAIL
16mm Desk Clamp
OABKT16D
10
ADDITIONAL INSTRUCTIONS
The luminaire itself is maintenance-free.
You can obtain additional documents about this product
from the manufacturer upon request.
These luminaires do not affect any other devices.
To save energy, the luminaire should only be switched on
when actually needed.
9
ENG
11
TROUBLESHOOTING
Fault
Possible cause
Troubleshooting
User profiles
The luminaire does not light
Contact problem
Switch on again
All
The luminaire does not light
No mains voltage
Check mains voltage, check
all connections
Electrician
The luminaire does not light
LED module defective
Contact manufacturer
service
By manufacturer service only
12
TECHNICAL DATA
Electrical data:
Rated input voltage
100 - 240VAC
Frequency range
50/60 Hz
Power consumption
12-15W (14-20VA)
Input current
0.08-0.14A
Power factor
0.75-0.86
Power supply secondary side
24VDC
Photometric values:
Central illuminance Ec at 0.5m (1.64 feet) distance
60‘000 lx *
Light field diameter d10 at 0.5m (1.64 feet) distance
Ø = 21cm (8.3”) *
Light field diameter d50 at 0.5m (1.64 feet) distance
Ø = 12 cm (4.7”) *
Colour temperature
4500K / 3500K *
Colour rendering index Ra
>95
Colour rendering index R9
>90
Total irradiance Ee at maximum intensity
<230 W/m
Ratio irradiance Ee to illuminance Ec
3.83 mW/m /lx
2
2
* -10% / +20% tolerace
Ambient conditions for transport, storage and operation:
Ambient temperature (storage and transport)
-20°C to +70°C (-4°F to +158°F)
Ambient temperature (operation)
+10°C to +35°C (+50°F to +95°F)
Relative humidity (non-condensing) (storage and transport)
max. 90%
Relative humidity (non-condensing) (operation)
max. 75%
Weight:
Luminaire head
0.6kg (1.3 lb)
CLED23 T1C
9kg (19.8 lb)
CLED23 TXPPS
2kg (4.4 lb)
Mode of operation:
Mode of operation
10
Continuous operation
ENG
Classification:
CLED23
Protection class I (C-version
Protection class II (PPS-version)
Degree of protection according to IEC 60529
Luminaire head (only in horizontal position)
IP 20
IP 43
Classification according to directive 93/42/EWG – annex IX (medical device class)
U.S. FDA Device Class
Class I
Class I
Electrical safety test and EMC according to:
IEC 60601-1
IEC 60601-2-41
IEC 60601-1-2
GMDN-Code
12276
Service life of the light source:
Service life LED
30‘000h (L70/B50)
11
ENG
13
ELECTROMAGNETIC COMPATIBILITY (EMC)
Electromagnetic emission 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
Group 1
The medical device uses HF energy exclusively for its internal function. This
(CISPR 11)
means that its HF emissions are very low, and it is unlikely that adjacent electronic
devices will receive interference.
High-frequency emissions
Class B
The medical device is intended for use in all facilities, including residential
(CISPR 11)
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 the
Electromagnetic environment
level
medical device
Electrostatic discharge (ESD) Contact discharge: ± 6 kV ± 6 kV
Floors made of timber, concrete or ceramics tiles
(IEC 61000-4-2)
Air discharge: ± 8 kV
± 8 kV
are preferred. Where synthetic floor covering is
used the relative humidity should be at least 30%.
Fast transients/
Power supply cables: ± 2
± 2 kV
The quality of the mains power supply should
electrical disturbance
kV
match that of a typical business or hospital
variables/
Longer input and
Not applicable
environment.
bursts (IEC 61000-4-4)
output cables: ± 1 kV
Surge voltages/surges
±1 kV phase-to-phase
±2 kV
The quality of the mains power supply should
(IEC 61000-4-5)
voltage
match that of a typical business or hospital
±2 kV phase-to-earth
±1 kV
environment.
voltage
Magnetic field in the power
3 A/m
3 A/m
In proximity of this medical device, do not operate
supply frequency (50/60 Hz)
devices with unusually strong network-frequency
(IEC 61000-4-8)
magnetic fields (transformer stations etc.) .
Voltage dips and short
Cut >95 %, 0.5 periods
Cut >95 %, 0.5 periods
The supply voltage quality should be that of a
interruptions
Cut 60 %, 5 periods
Cut 60 %, 5 periods
typical business or hospital environment. If the
to the power voltage
Cut 30 %, 25 periods
Cut 30 %, 25 periods
user requires continued function during any
(IEC 61000-4-11)
Cut >95 %, 5 seconds
Cut >95 %, 5 seconds
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
3 V/m
3 V/m
Recommended minimum distance of portable and
variable (IEC 61000-4-3)
80 MHz - 2.5 GHz
mobile radio devices of PEIRP radiated power to
the medical device, including its cables: d = 1.17√P
Conducted HF disturbance
3 Vrms-value
3 Vrms-value
Recommended minimum distance of portable and
values (IEC 61000-4-6)
150 kHz - 80 MHz:
mobile radio devices of PEIRP radiated power to
the medical device, including its cables:
80MHz - 800MHz: d = 1.17√P
800MHz - 2.5GHz: d = 2.33√P
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
0.12 m (0.39 ft)
0.23 m (0.75 ft)
0.1
0.37 m (1.21 ft)
0.74 m (2.43 ft)
1
1.17 m (3.84 ft)
2.33 m (7.64 ft)
10
3.7 m (12.14 ft)
7.37 m (24.18 ft)
50
8.27 m (27.13 ft)
16.48 m (54.07 ft)
100
11.7 m (38.39 ft)
23.3 m (76.44 ft)
12
These installation and operating instructions are for customer information only and will only be updated or replace upon request by the customer
http://www.brandon-medical.com
e-mail: [email protected]
© Brandon Medical Co. Ltd. • D80.020.000 • 04.2014 • Index: 1.2 • Subject to modification • printed in Switzerland
Brandon Medical Co. Ltd.
Elmfield Road, Morley
Leeds
LS27 0EL
Telephone: +44 (0) 113 27 77393
Fax: +44 (0) 113 27 28844
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