PASCAL
®
Synthesis TwinStar Ophthalmic Scanning Laser Systems
Page 124 of 142
88293-EN, Rev C
Instructions for Use
Intended Use Environment
The intended Use Environment of the laser system is as follows:
•
Professional Healthcare Facility Environment
•
Physician offices, clinics, multiple treatment facilities, hospitals except for near
active HF surgical equipment and the RF shielded room of an ME system for
magnetic resonance imaging, where the intensity of EM disturbances is high.
Patient Environment
The Patient Environment is defined by the following:
•
When the patient or inspector comes in contact with the devices (including the
connecting devices)
•
When the patient or inspector touches the person that comes into contact with the
devices (including the connecting devices).
In the patient environment (shown below), use the device conforming to IEC 60601-1
standard. If you are compelled to use any device not conforming to the standard, use an
insulation transformer which conforms to IEC 60601-1 standard.
Devices applicable to the
use in patient environment:
•
Insulation transformer
Radius 1.5 m
1.5 m
1.5 m
2.5 m
