Chapter 6 Safety and Regulatory
Page 222 of 314 Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
The LIQUID OPTICS™ Interface is a Type B Patient Applied Part per IEC 60601-1. The footrest,
seat, backrest, headrest, and armrests for the Mobile Patient Bed are Type BF Applied parts. The
headrest, backrest, seat, and footrest for the Patient Chair are Type B Applied parts.
The LIQUID OPTICS™ Interface is not made with natural rubber latex.
The CATALYS® System is Class 1 (Electrical Protection) medical electrical equipment.
This device complies with Industry Canada’s license-exempt RSSs. Operation is subject to the
following two conditions: (1) This device may not cause interference; and (2) This device must
accept any interference, including interference that may cause undesired operation of the
device.
6.2 Ocular Protection
WARNING
Never look directly into the laser aperture or scattered laser light from reflective surfaces when
the treatment beam is activated. Severe eye damage could occur.
Laser Safety Eyewear
There are two conditions of system operation that need to be considered when defining the
requirements for use of Laser Safety Eyewear: normal system operation and system alignment
verification.
Normal System Operation
During normal operation of the CATALYS® Precision Laser System, there is no user-accessible
exposure to the Class 4 and Class 3 beams except for the intentional exposure of the patient for
therapeutic purposes. The patient is in contact with the laser aperture of the system by means
of the LIQUID OPTICS™ Interface. The interface keeps the laser beam confined to the patient
and prevents accidental exposure to the treatment room personnel. The CATALYS® System also
imposes multiple sensor and safety checks to insure that no laser energy is emitted unless there
is a patient in contact with the laser aperture by means of the LIQUID OPTICS™ Interface.
For the OPTIMEDICA CATALYS® Precision Laser System during normal system operation, the
NOHD is 0 (zero) m. Laser safety eyewear is not required for any personnel during normal
system operation.
System Alignment Verification
During performance of the daily system alignment verification, as described in System Basics on
page 39, the trained operator does not need to wear laser safety eyewear, because the
treatment beam is directed into the opaque backing of the clear plastic hemisphere.
CAUTION
Use only OPTIMEDICA part number SA‐08044 for verifying system alignment. Previous versions
of the plastic hemispheres are obsolete and should not be used.
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