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4. A separation device (isolation device) is needed to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular, such a
separation device is required when a network connection is made. The requirements for separation
devices are defined in IEC 60601-1, edition 3, clause 16.
5. The system must not be used in the presence of explosive or flammable gases.
6. The system must be switched off before cleaning.
7. Do not use any additional multiple-socket outlet or extension cord.
8. For irrigators, to avoid the risk of electric shock, this equipment must only be connected to a supply
main with protective earth.
9. The manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel designated by the
manufacturer to repair those parts of this system.
10. For maximum electrical safety, turn off the power to the equipment when it is left unused.
11. The equipment is not protected against harmful ingress of water or other liquids. If any spillage
occurs, check the equipment carefully before use or contact the manufacturer for service.
12. Do not use the equipment before service, if it shows a visible or suspected damage.
13. Grade 2 laser stimulus is used in the Orion Auto
Traverse / Orion Comprehensive chairs and the
System 2000 Auto Traverse / System 2000
Comprehensive chairs against the booth enclosure.
Both operator and patient should avoid looking into
the laser beam. There are no user-serviceable
components in the laser box assembly.
14. Do not service any part of the equipment while in use with a patient.
CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not
avoided, could result in damage to the equipment.
1. Before using the system, it is mandatory to read the user manual, labels and other additional
information. The system should be used as described in the user manual only.
2. The system should only be operated by qualified technicians with appropriate training.
3. The system must be serviced at least once a year. The service must include a safety test.
4. Handle the device components carefully to avoid system damage.
5. Allow the system to obtain room temperature before using the equipment. Any components that
have been stored previously should be brought to room temperature before usage.
6. It is important to ensure that the rotational chair center is situated at least 1 meter (39 inches) from
the center axis to any adjacent object to accommodate its reclined position.
NOTICE
NOTICE is used to address practices not related to personal injury or damage to the equipment.
1. A CLASS 1 laser stimulus is used in the EyeSeeCam goggles. A
CLASS 1 laser is safe under all conditions of normal use. This means
the maximum permissible exposure (MPE) for this beam is not
exceeded when viewed with the naked eye or with the aid of typical
magnifying optics.
2. No other PC programs should be running or minimized while testing the patient with the software.
This can interfere with the VisualEyes™ system's software.
3. To prevent system faults, take appropriate precautions to avoid PC viruses and similar.
4. Although the equipment fulfils the relevant EMC requirements, precautions should be taken to avoid
unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used
adjacent to other equipment, it must be observed that no mutual disturbance appears.
D-0134090-A – 2022/11
VisualEyes™ - Instructions for Use - EN
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