Range Of Applications; Applicable Standards; Warnings And Cautions - Gima 31527 Manual De Instrucciones

Range of applications

- The Sigma ophthalmoscope is designed for examination of the eye.
- During examination, hold the instrument with your index finger on the lens wheel (a). you can also operate
the aperture wheel (c) in this way.
- Window (b) shows the selected lens value. Minus lenses are shown red, plus lenses black.
Do not use the equipment in case it is damaged. Apply to your retailer.
Operating Instruction
Attach the ophthalmoscope head to the handle and turn on the device for examination, turn the wheel (a)
clockwise or counterclockwise to select the desired lens. The power of the selected lens is visible through
window (b). Sigma ophthalmoscope is equipped with a set of 5 different aperture, which can be selected by
turning the wheel (c).
Changing the lamp
Unscrew the instrument from the handle and pull the lamp (d) downwards. Wipe the new lamp glass clean
and insert it so that the locating pin (e) fits the slit.
Allow lamp to cool down for some time before replacing it.
Cleaning
The housing can be wiped clean with a cloth moistened with alcohol. Glass surfaces can be cleaned with a
cotton wool bud in the same way.

Applicable Standards

ISO 15004-1 (Ophthalmic instruments - Fundamental requirements and test methods).
The performance of this instrument can only be guaranteed if genuine Medical Devices lamps and
alkaline batteries are used.

Warnings and Cautions

The light emitted from the ophthalmoscope is potentially hazardous.
The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instru-
ment, when operated at maximum intensity, will exceed the safety guideline after 13 minutes when Iit with a
LED lamp (blue base). Exposure times are cumulative for a 24-hour period.
• 333 seconds (5 min 33 sec) in case of a free eye
• 227 seconds (3 min 47sec) in case of a fixed eye
When using Halogen illumination, no acute optical radiation hazards are identified. However, Medical
Devices recommends limiting the intensity of the light directed into the patient's eye to the minimum
level that is necessary for diagnosis. Infants, persons with aphasia, and persons with diseased eyes
are at a greater risk. The risk is also increased if the examined person has had any exposure with the
same instrument or any other ophthalmic instrument using a visible light source within the previous
24 hours. This will apply particularly if the eye has had exposure to retinal photography. The intended
use of this device is for routine ophthalmic exams on the order of typically less than 60 seconds per
eye. Although there is a benefit versus risk factor in any medical procedure, these more complicated
exams should not exceed a three minute exam time in 24 hours. Significant use of this device beyond
its intended use is not recommended; it may cause harm to the eyes.
Feature
• Made from impact resistant re-enforced plastic.
• Enhanced Xenon/Halogen super bright light.
• Easy replacement of lamp.
• 5 different apertures.
ENGLISH
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