RSR-000885-000 (6)
Page
6
of
20
3.3. Maximum Permissible Exposure (MPE)
Maximum Permissible Exposure (MPE) is the highest power density (in W/m
2
) from a light source that does not require clinical evidence to be
considered safe. For the laser radiation from the laser system, the MPE for ocular and skin exposure is determined by the wavelength, beam
divergence, and exposure time. For times between 10 and 3000 seconds, the ocular MPE is 418.9 W/m
2
and the skin MPE is 3027.1 W/m
2
.
3.4. Laser Console Diagrams
3.5. Empower IQ™ Delivery System
Caution:
Do not bend the optical fiber too sharply: the minimum permissible bending radius is 40 mm. Mishandling of the fiber may
lead to damage to the fiber or delivery system and/or harm to the patient or laser operator.
Warning:
•
If any part of the Empower IQ Delivery System overheats or produces smoke, immediately power off the Laser System,
discontinue operation, and contact Customer Care for assistance.
•
The new Empower IQ features are not meant to replace user training or the need to observe and respond to patient feedback
during treatment.
•
The use of accessories and/or optical fiber cables not specified for use with this Laser System may result in unsafe emissions
or damage to the Laser System.
•
When treating at higher powers (>25W), wait five minutes between successive treatments of >15,000 Joules to prevent
overheating. If the handpiece becomes uncomfortable to hold, discontinue treatment. If the handpiece continues to produce
excessive heat, then discontinue use of the device and contact Customer Care for assistance.
The Empower IQ Delivery System is composed of a double-sheathed optic fiber and a hand piece with interchangeable
treatment heads. The laser emission is controlled with a finger switch on the hand piece. The functionality of the finger switch
is influenced by the “Override” setting in Setup. When the operator is administering a treatment with Override
Off
, the finger
switch must be held down continuously to enable emission. When Override is
On
, the finger switch acts as an ON/OFF switch
allowing the operator to press once and release to enable continuous emission.
Warning:
The
Override On
setting for the finger switch should only be used by a qualified laser technician.
To end emission, the operator will then press and release again, which will return the laser to
Ready
mode. The laser system will remain in
Ready
mode until the operator resumes the treatment or selects
Standby
on the touchscreen
to return to
Standby
mode.
Warning:
•
DO NOT press the finger/foot switch without first verifying the safe orientation and
proper positioning of the distal end of the optical fiber and hand piece. Ensure
compliance with all safety precautions.
•
DO NOT
operate the laser system without a treatment head (
Figure 12
). This can
cause serious injury.
•
DO NOT
operate the laser system with an improperly attached or loose-fitting
treatment head (
Figure 13
). This can cause serious injury.
Figure 12
Figure 13
11
1.
Power Button
2.
Emission Indicator LED
3.
Emergency Stop Button
4.
Touchscreen Display
5.
Front Vent & Speakers
6.
Laser Warning Labels
7.
UDI Label
8.
Product Label
9.
Remote Interlock
10.
Warranty Seal
11.
Rear Vents
12.
Foot Switch Receptacle
13.
VGA Port (For Mfg Use ONLY)
14.
USB Port
15.
Power Cord Receptacle
5
3
4
2
1
9
7
8
10
6
Recommendation:
As the aiming beam passes down the same delivery system as the working beam, it provides a good means of
checking the integrity of the delivery system. If the aiming beam is not present at the distal end of the delivery system, its intensity is
reduced or it looks diffused, this is a possible indication of a damaged or malfunctioning delivery system.
11
14
15
12
13
Summary of Contents for LIGHTFORCE XLi
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