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Step 4.
Secure the finger switch connector by carefully pushing it into the finger switch port (Figure 13).
Step 5.
Remove the protective dust cap from the end of the new optical fiber cable.
Step 6.
Open the hinged door covering the emission port and insert the fiber tip straight into the emission port (Figure 14). Twist the
metal connector clockwise onto the threaded emission port until tight.
3. Device Description
The laser systems include a therapeutic laser console and optical delivery system. The optical delivery system consists of a flexible optical fiber
connected to a hand piece with interchangeable treatment heads. A custom software application allows the user to select from built-in treatment
protocols that adjust dosage and wavelength based on the patient's characteristics and condition. The device also provides the ability to set
custom treatment parameters including output power, treatment time, and pulse rate. Once the user has selected the desired treatment
parameters, activation of laser emission requires that the operator follow a sequence of predetermined steps.
3.1.
Indications for Use
810 nm and 980 nm wavelength:
The laser system emits energy in the visible and near-infrared spectrum to provide topical heating for the purpose of elevating tissue
temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary
increase in local blood circulation; the temporary relaxation of muscle.
The device is meant for professional use only by licensed practitioners.
Caution: Federal, national, or local laws may restrict this device to sale by or on the order of a licensed practitioner licensed by the
applicable authorities to use and/or prescribe use.
3.2.
Contraindications
•
Do not apply infrared light to abdominal or lumbosacral points in pregnant females.
Do not apply infrared light to the epiphyseal lines in children.
•
•
Do not apply infrared light to the thoracic region or over the pacemaker itself in patients with pacemakers.
•
Do not apply infrared light over the thyroid gland, ovaries or testicles.
Do not apply infrared light to patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to
•
certain types of steroids.
3.3.
Maximum Permissible Exposure (MPE)
Maximum Permissible Exposure (MPE) is the highest power density (in W/m
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
3.4.
Laser Console Diagrams
1.
Power Button
2.
Emission Indicator LED
3.
Emergency Stop Button
4.
Touchscreen Display
5.
Laser Warning Labels
6.
Fiber Optic Cable
7.
Strain Relief
8.
Hand Piece Handle
9.
Hand Piece Clip
10. Speaker
11. Fiber Manager Spool
12. USB Port
13. Remote Interlock
14. Foot Switch Port
15. DC Input (Power Supply Port)
16. Warranty Seal
17. Finger Switch Marking
18. Applied Part Marking
19. Optical Applicator Marking
20. Battery Cover
21. Product Label
RSR-000886-000 (5)
Figure 14
4
3
2
1
12
13
Emission port
(behind hinged cover)
Finger Switch port
(USB-C port)
Figure 13
2
) from a light source that does not require clinical evidence to be
2
and the skin MPE is 3027.1 W/m
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16
15
14
2
.
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