PASCAL
®
Synthesis TwinStar Ophthalmic Scanning Laser Systems
Page 25 of 142
88293-EN, Rev C
Additional Safety Considerations
WARNING
US federal law restricts this device to sale by or on order of a physician. (CFR
801.109(b)(1))
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
Iridex Corporation medical devices are solely for use by physicians trained in the
operation of laser photocoagulation and associated delivery devices.
To avoid potential injury to the user and the patient and/or damage to this device, the user
must:
•
Read this manual thoroughly and be familiar with its contents prior to using this
equipment.
•
Be a qualified physician, having complete knowledge of the use of this device.
•
Test this device prior to a procedure.
•
Attempt no internal repairs or adjustments not specifically detailed in this manual.
Do not modify this equipment without authorization of the manufacturer.
When the laser system is interconnected with other medical electrical equipment, leakage
currents may be additive. Ensure all systems are installed according to the requirements
of IEC 60601-1.
If the laser system is used adjacent to or stacked with other equipment, observe and verify
normal operation of the laser system in the configuration in which it will be used prior to
use.
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the
laser system, including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
CAUTION
Condensation may occur if the equipment is exposed to high humidity for an extended
period of time.
