RSR-000885-000 (6)
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14
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Press the
exit
button and reset the system. Make sure that the ambient temperature of the laser system is within the operating temperature
range of the device. If the problem still exists, contact Customer Care for further troubleshooting.
If the laser system will not turn on:
•
Make sure that the power cord is correctly attached and plugged into a functioning power outlet.
5.3. Calibration Check Procedure
The instructions below provide steps for performing a calibration “check” that may be performed with certified, NIST traceable equipment. This
procedure is recommended to be performed once a year but is not required unless there is evidence of significant damage or diminished
output. If during the execution of this procedure, the stated requirements are not met, then factory maintenance and re-calibration may need
to be performed on the device. Factory calibration must be performed by certified Service Personnel.
Caution
: Calibration is a service procedure to be done only by certified Service Personnel. Adjustment to any internal components
by anyone other than certified Service Personnel voids any existing manufacturer’s warranty on the Laser System.
Warning:
Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous
radiation exposure. Avoid eye or skin exposure to direct or scattered radiation when open.
Laser Power Calibration Check Instructions
Warning:
ALWAYS wear laser safety goggles when performing the laser calibration check procedure and follow all laser safety
guidelines.
Equipment Needed:
Certified traceable power meter and detector (
Figure 27
) with appropriate wavelength
and power measurement capabilities
Step 1.
Turn off the laser.
Step 2.
Inspect and attach optical fiber and power cord as directed. Make sure the optical fiber is clean
and free of any dust, fluid or other contaminants.
Step 3.
Turn on the laser system and enter Standby mode.
Step 4.
Increase the power setting until it reaches the maximum wattage setting.
Step 5.
Place the laser in Ready mode.
Step 6.
Using the aiming beam, direct the distal end of the fiber into the active area of the power meter.
Keep the fiber tip 2-3 cm away from the surface of the active area of the power detector.
Step 7.
Activate the laser and record the value in watts from the power meter display. The laser power
reading should be within ± 20% of the power setting.
a. If the results are outside the 20% range, ensure that: all of the light from the fiber is entering the detector, the fiber
is connected correctly, and the fiber is not damaged. Replace with a new fiber if necessary and repeat.
b. If the results are still outside the 20% range, discontinue this procedure and contact Customer Care for assistance.
6. Quality and Regulatory
6.1. Quality Systems
The LightForce Therapy Laser Systems were designed, developed, and manufactured in accordance with ISO13485:2016 – Medical Devices
– Quality management systems.
6.2. Device Classification
According to the applicable standards, the laser systems are classified as follows:
•
Class I Type B device per EN/IEC 60601-1
•
Class 4 laser product according to EN/IEC 60825-1
6.3. Declaration of Conformity (EU)
PRODUCT IDENTIFICATION
Product name
Model/number
LightForce
®
Therapy Lasers
LTS-2500-L-S8
LightForce
®
XPi
LTS-4000-L-S8
LightForce
®
XLi
MANUFACTURER
Name of company
Address
Representative
LiteCure, LLC
101 Lukens Drive, Suite A
New Castle, DE 19720
USA
Quality & Regulatory Director
AUTHORIZED REPRESENTATIVE
Name of company
Address
Telephone/email
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
+31.70.345.8570 - phone
+31.70.346.7299 - fax
europe@emergogroup.com
REGISTRATION INFORMATION
Notified Body and ID #
Marking
CE certificate number
BSI Group, 2797
CE 542523
Figure 27
Summary of Contents for LIGHTFORCE XLi
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