HEINE OMEGA 500 Manual De Instrucciones página 9

not permitted. Please only use disinfectants based on alcohol. The lamp can
be cleaned, with a dry cloth if necessary.
If touched a patients eye with the loupe you can also disinfect the loupe by
Incidin Liquid and Bacillol plus.
® ®
We recommend to use Incidin
®
Cleaning and disinfection is allowed with a damp cloth only.
Sterilisation of OMEGA 500 is not allowed.
Maintenance
OMEGA 500 Indirect Ophthalmoscopes do not require regular maintenance.
Change XHL bulbs if necessary.
Service
OMEGA 500 Indirect Ophthalmoscopes do not require regular service.
Disposal
The product must be recycled as separated electrical and electronic
devices. Please observe the relevant state-specific disposal regulations.
Technical specification
Weight: 470 g (Instrument)
Environmental conditions operation:
Temperature: +5 °C to +35 °C
Relative humidity: 30% to 90%
Air pressure: 800 hPa to 1060 hPa
Environmental conditions storage:
Temperature: -20 °C to +50 °C
Relative humidity: 10% to 95%
Air pressure: 700 hPa to 1060 hPa
Environmental conditions transport:
Temperature: -40 °C to +70 °C
Relative humidity: 10% to 95%
Air pressure: 500 hPa to 1060 hPa
General Notes and Warnings
The indirect opthalmoscope OMEGA 500 in its original packaging meets the
requirements for transport according to ISO 15004-1.
OMEGA 500 meets the requirements according to EN ISO 10943:2011.
General Notes
Check the correct operation of the OMEGA 500 at regular intervals. Do
not use the equipment if it shows visible signs of damage.
OMEGA 500 is not allowed to be entered into strong magnetic fields like
MRI scanners.
Use as little light as possible for the examination and ensure that the
light is switched off after each examination. Please always consider your
medical duty of care.
Do not remove the bulb when it is hot. Please allow the bulb to cool down
prior handling.
Do not look into bright light sources by means of loupes. Hazard of glare.
Avoid the ophthalmoscope lens to be exposed to direct sunlight. Hazard
of fire.
Remove mPack UNPLUGGED Battery if you do not use OMEGA 500 for
a longer time.
It is not allowed to modify OMEGA 500.
Do not use OMEGA 500 in oxygen enriched environment.
Use only original HEINE ophthalmoscope lenses.
Use only original HEINE bulbs (X-004.88.111, X-008.87.200) in combi-
nation with HC 50 L. Other bulbs could influence the light and lead to
an overexposure or underexposure of light, resulting in eye damages or
wrong diagnoses.
Use only Power sources specified by HEINE for the use of the OMEGA
500. Other power sources could influence the light and lead to an over-
exposure or underexposure of light, resulting in eye damages or wrong
diagnoses or lead to overheating of the device.
Only use the OMEGA 500 when the lenses are clean.
Electric shocks or burns can be prevented by only sending the device to
HEINE for repair.
OMEGA 500 is a precise optical instrument. Please handle OMEGA 500
with care and store it in a clean place. Please clean the OMEGA 500
optics in regular intervals to ensure best diagnostic conditions.
Let OMEGA 500 accommodate to ambient conditions when the instru-
ment is cold.
Change the ocular lens only in a clean environment in order to avoid dust
to enter the OMEGA 500.
We can only guarantee the performance of the instrument when fitted
with original HEINE accessories and spare parts.
The LED indicator of the power supply or the charge indicator on the
backside of the mPack UNPLUGGED Battery are the operating indicator
of the OMEGA 500.
Liquid und Bacillol plus to disinfect the device.
®
Phototoxicity
Because prolonged intense light exposure can damage the retina, the
use of the device for ocular examination should not be unnecessarily
prolonged, and the brightness setting should not exceed what is needed
to provide clear visualization of the target structures. This device should
be used with filters that eliminate UV radiation (< 400 nm) and, whenever
possible, filters that eliminate short-wavelength blue light (<420 nm).
The retinal exposure dose for a photochemical hazard is a product of the
radiance and the exposure time. If the value of radiance were reduced
in half, twice the time would be needed to reach the maximum exposure
limit. While no acute optical radiation hazards have been identified for
direct or indirect ophthalmoscopes, it is recommended that the intensity
of light directed into the patient's eye be limited to the minimum level
which is necessary for diagnosis. Infants, aphakes and persons with
diseased eyes will be at greater risk. The risk may also be increased if the
person being examined has had any exposure with the same instrument
or any other ophthalmic instrument using a visible light source during the
previous 24 hours. This will apply particularly if the eye has been exposed
to retinal photography.
OMEGA ® 500 Ophthalmoscope is classified as a Group 2 instrument
according to EN ISO 15004-2:2007. The classification was performed
together with HEINE A.R. 16D/Ø54mm Ophthalmoscopy loupe.
Caution – The light emitted from this instrument is potentially hazardous.
The longer the duration of exposure, the greater the risk of ocular damage.
Exposure to light from this instrument when operated at maximum
intensity should not exceed 21 minutes with the LED light and 15 minutes
with the 5Watt XHL light.
Electromagnetic Compatibility
Medical electric devices are subject to special precautionary measures with
regard to electromagnetic compatibility (EMC). Portable and mobile high
frequency communication equipment can affect medical electric devices. The
HEINE OMEGA
®
ronment specified below. The user of the HEINE OMEGA
assure that it is used in such an environment.
The ME device may not be stacked directly near or used directly beside
other devices. If the ME device is to be operated in a stack or with other
devices, the device should be watched to ensure it operates properly in
this location.
Outgoing
Measurements
RF emissions acc. to
CISPR 11
RF emissions acc. to
CISPR 11
Harmonic emissions
acc. to IEC 61000-3-2
Voltage fluctuations/
flicker emissions acc.
to IEC 61000-3-3
med 0912 2016-06-30
500 LED is intended for use in the electromagnetic envi-
Compliance
environment – Guidelines
Group 1 The equipment uses only RF
energy for its internal function.
Therefore, its RF emissions
are very low and are not likely
to cause any interference in
nearby electronic equipment.
Class B The ME device is suitable for
use in all facilities (e.g. hos-
pitals and medical practices),
including domestic situations
and those directly connected
to the public low-voltage
power supply network that
supplies buildings for domestic
purposes.
Class A Illumination equipment with
controls.
Fulfilled
® 500 LED should
Electromagnetic
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