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Clement Clarke 2001 - Intended Use; Safety and Regulatory Information

Clement Clarke 2001
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3
Synoptophore Instructions
2. Intended Use
The fundamental parts of the Synoptophore are two
independently movable sight tubes. With the instrument
set at zero (sight lines parallel) the two images, super-
imposed, will be seen as one integrated figure by a
subject with normal binocular vision. A subject with
strabismus, divergent or convergent, will only see a
superimposed (fused) figure with ease, when the sight
tubes are set at an angle to each other (angle of
deviation). The muscles are exercised by looking through
the tubes at the deviation angle and moving them
laterally in unison, so that the subject scans left and right
alternatively. Single eye exercise can be given by
gradually changing the angle between the sight tubes
whilst the subject maintains fusion for as long as
possible.
3. Safety and Regulatory
Information
The Synoptophore may only be exposed to the
following environmental/ambient conditions for
transportation, storage purposes:
Ambient temperature: -40˚C to 70˚C
Humidity: 10-95% RH
Atmospheric pressure: 500hPa to 1060hPa
The Synoptophore should be checked for damage
after unpacking.
Defective equipment should always be returned in
appropriate packaging.
Notes on Usage
Only qualified and trained personnel may operate the
equipment.
The training of the operating personnel is the
responsibility of the equipment user.
This type of sensitive measuring equipment should
be checked after exposure to external force (e.g.
unintentional shocks or being allowed to fall) and
if necessary, should be returned to the manufacturer
for repair.
Reinforcement routines on and alterations to the
equipment may only be carried out by authorised
servicing technicians.
The manufacturers of the equipment will not be
liable for any loss or damage resulting from unauthorised
intervention.
In particular, it is forbidden to loosen any screws; this
may reduce the accuracy of the measurement. All
ensuing warranty claims will be deemed null and void
as a result of unauthorised intervention.
Parts in contact with the body:
Chin Rest, Forehead Rest, eye piece and Handles for
adjustment of the horizontal angle between tubes, are the
applied parts.
Operating temperature +10˚C to +40˚C.
Warning:
To avoid risk of electric shock, this equipment must only
be connected to a mains supply with protective earth.
Please Note:
The HB Motor should not be run continuously.
Please switch off between patients.
Please Note:
The weight of the instrument should not exceed 20Kg.
Please Note:
Position the equipment making sure the power lead
and plug are easily accessible.
Please Note:
It is recommeded that the Synoptophore is
serviced annually.
Warning:
No modification of this equipment is allowed.
Recommended Fuse:
Littelfuse, 5 x 20mm, time lag fuse 213 series is
recommended.
Statutory Requirements
The Synoptophore is designed as a Class 1 device with
a measuring function device under rule 12 of the
Medical Device Directive 93/42/EEC.
The Synoptophore complies with the Ophthalmic
regulation ISO 10944:2009 & EN ISO 15004-1:2006.
Caution
The safety regulations displayed in the operating
instructions are to be observed with special care.
Caution
Strictly observe all warning notices!
Electrical Specifications
Voltage: 110V 60Hz/230V 50Hz, 54VA
Fuse Rating: T1AL, T500mAL, 250V AC
Regulatory Information: CE-Mark
The products fulfill the requirements according to the
following standards:
Safety: EN60601-1 Part 1:
General Requirements for Safety,
Medical Electrical Equipment
Electrical: EN60601-1-2 Part 2: Collateral Standard:
Electromagnetic Compatibility
Environmental Conditions
Conditions for safe operation of the Product:
Ambient temperature: +10˚C to +40˚C
Humidity: 30% rh to 75% rh
Atmospheric pressure: 700hPa to 1060hPa
Dust Cover
A cover is provided to prevent dust accumulating.
Please switch the device off before covering.
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