Leaf User Manual
P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 62 of 85
Additional Safety Considerations
US federal law restricts this device to sale by or on order of a physician.
Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
Norlase 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. Do not use cables or accessories other than those
provided with the laser system, as this may result in the increased electromagnetic
emissions or decreased immunity to such emissions.
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.
Condensation may occur if the equipment is exposed to high humidity for an
extended period of time.
Vibration or physical shock may affect the quality, performance and reliability of
the equipment.
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