1.2.3 Cautions, Warnings, and Contraindications
WARNING Carefully read the operation manual before operating the device. Misuse of
the device may lead to incorrect diagnostic results.
WARNING Do not examine a patients eye longer then 30 minutes. A too long
examination time might lead to damages of the retina.
WARNING The camera housing can get very hot after continuous operation. It is
recommended to switch off the device between examinations. Caution is
recommended when touching the camera housing.
WARNING Do not open the device component housings. Doing so may result in
electrical shock.
WARNING Do not use the device outside the scope of its “Intended use”. Doing so may
lead to malfunctions or damage of the device.
WARNING Do not use PCs, components or accessories that have not been approved by
Heidelberg Engineering. Do not install other software, as this may interfere
with the functionality of the Heidelberg Engineering software or equipment,
cause damage to the system or lead to incorrect measurement results.
WARNING Always use a network connection with network isolation in accordance with
IEC 60601-1 (isolating transformer). Without isolation transformer, user and
patient could be at risk of electrical shock in the event of an error.
WARNING Make sure that the environmental requirements are met when the system is
operated. Exceeding environmental conditions may damage the system or
lead to incorrect measuring results.
WARNING Wrong examination preparation of the device and the patient may lead to
bad or insufficient pictures.
WARNING Be aware of possible allergic reactions, when contrast or dye fluid is injected.
Closely follow the package information leaflet. Do not perform more than
one examination per day on the same patient. Multiple injections of the
contrast or dye fluid may result in allergic reactions or shock.
WARNING Incorrect application of contrast / dye fluid may cause allergic reactions or
shock, injury or illness. It may also cause follow up treatment or bad
examination results.
WARNING Make sure the patient is correctly positioned in front of the device before
starting the examination. Wrong positioning may lead to poor images and
incorrect diagnostic results.
WARNING Artefacts on the images could falsify the measured results. Do not use the
measured results if there are artefacts in the images.
WARNING Do not make a diagnostic decision on the basis of one single examination.
The device is not clinically evaluated for the diagnosis of specific
pathologies. So always use alternative information; history data etc. to assist
in a final diagnostic determination.
WARNING Prepare safeguards to ensure that only authorized personnel can access the
patient data. Data loss impedes follow-up analyses and may result in
inappropriate diagnostic decisions.
HRC Installation Instructions Vers. 001
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