USER MANUAL
(Instruction for Use)
SW 2.9
Safety
Version 2.9.7 dated 2020-12-23
Page 17 of 75
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Further information on electromagnetic compatibility (EMC)
Despite adherence to all applicable EMC requirements, malfunctioning cannot be ruled out
entirely. This equipment has been tested and found to comply with the limits of EN 60601-1-2 for
medical devices. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates, uses and radiates radio
frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
Relocate the receiving device.
Separate the equipment by increasing the distance.
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected. Consult the manufacturer or field service engineer for assistance.
2.6
Operator’s Responsibility
In order to ensure the safety of patients and user’s personnel as well as the proper function of
the device, the operator / user must undertake certain measures as listed in the following
chapters.
2.6.1
Patient and Personal Safety
The purpose of safety precautions and preventive measures is to reduce the possibility of injuries
to the patient and to avoid other risks.
WARNING
Risk of injury!
Only a suitable trained and from SCHWIND eye-tech-solutions authorized
personnel should operate, maintain and repair the medical device.
Take care not to injure the patient when positioning the medical device.
Make sure that the patient remains calm and relaxed during the treatment.
Do not swallow, open, recharge or expose to water, fire or high temperature: may
explode, leak or cause damage.
Any complication or difficulty in using the device that could generate
misunderstanding or ambiguities need to be taken into account to avoid risks to
the patient.
After activation and during operation of the medical system pay attention to error
messages and warnings displayed on the computer screen.
