HEINE OMEGA 600 Mode D'emploi page 10

Light exposure hazard
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. 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.
ISO 15004-2: Group 2 (LED)
Caution – The light emitted from this instrument is potentially
hazardous. The longer the duration of exposure, the greater the
risk of ocular damage. An exposure time with this instrument at
maximum intensity of longer than (see table exposure guideline)
will lead to the guideline hazard value being exceeded.
ANSI Z80.36-2016: Group 2 (LED)
Caution – The light emitted from this instrument is potentially
hazardous. The longer the duration of exposure, the greater is
the risk of ocular damage. Exposure to light from this instrument
when operated at maximum intensity will exceed the recommen-
ded maximum exposure (RME) of 2.2 J/cm2, unless additional
action is taken by the user to minimize exposure, after __ min
(see table exposure guideline). The risk of retinal injury at an
exposure of 2.2 J/cm2 is not high, but because some patients
may be more susceptible than others, caution is advised if this
radiant exposure value is exceeded. However, because of a
significant risk of injury at exposures exceeding 10 J/cm2, the
user should avoid exposures longer than __ min. (see table
exposure guideline).
Exposure Guidelines
Data for the highest brightness setting in visionBOOST
Working
distance
Without
ophthalmo- 400 mm *
scopylens
With
ophthalmo- 400 mm **
scopylens***
*) from instrument
**) from instrument to HEINE A.R. Aspheric Ophthalmoscopy Lens
(A.R. 16D), diameter: 54 mm, focal length: 16 dpt.
***) HEINE A.R. Aspheric Ophthalmoscopy Lens (A.R. 16D),
diameter: 54 mm, focal length: 16 dpt.
Disposal
The product must be recycled as separated electrical and
electronic devices. Please observe the relevant state-specific
disposal regulations.
Dispose the rechargeable battery (10) at your local collection
point.
The appendix contains following tables
- Electromagnetic disturbances – Requirements and tests
- Technical specification
- Explanation of the used symbols
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Duration Duration
according to according to
ANSI Z80.36- EN ISO
2016
15004-2:2007
30 sec 2 min 44 sec
28 min 169 min
MED 234766 2022-01-20