USER MANUAL (Instruction for Use) SW 6.1
Safety
Version 6.1.6 dated 2020-01-31 EN Page 26 of 201
WARNING
Risk of injury! Persons with pacemakers!
The SCHWIND AMARIS fulfils the requirements of IEC 60601-1 and IEC 60601-
1-2 for safety and electromagnetic compatibility of medical electrical devices.
Accordingly, the laser should have no influence on heart pacemakers that
comply with a device standard compatible with the above-mentioned
standards.
However we cannot exclude any influence completely.
Recommendations of the pacemaker manufacturer should also be observed.
Potential electromagnetic radiation can influence functionality of the laser and
other medical devices.
2.5.2 Device Safety
Follow the accident prevention regulations and regulations concerning installation,
operation and usage of medical products as listed in chapter 2.2 Regulations for Medical
Devices.
Use the system / medical device only for its intended purpose (refer to chapter 3.1
Intended Use).
Provide proper and secure conditions for the product.
Maintain all documentation in good condition and store them with the system / device.
Make sure that none of the labels on the system are removed or made illegible.
Request the inspection of the system / medical device at regular intervals (TSC).
2.5.3 Electrical Safety
To ensure the safety of personnel and the device, the following arrangements must be kept by
the operator:
Only a trained and from SCHWIND eye-tech-solutions authorized technician should perform
the service or repair works on the electrical equipment of the device.
Inspect the electrical equipment for proper fitting and connection, damage to cables, lines
and housing at regular intervals.
Disconnect the power supply immediately in case of fire.
Extinguish fire only with CO
2
or powder extinguisher.
To Next Page
Loading...
