If There Are Scratches On The Massage Ball; Calibration Check Procedure; Laser Power Calibration Check Instructions; Quality And Regulatory - Companion Ctx Benutzerhandbuch

5) When the unit is charging properly, the battery icon will blink green. Unplug the cord from the rear of the laser to determine charge
state. If the icon does not blink and the unit still does not power on when plugged in, then contact Customer Care for further
assistance.
8.2.3.

If there are scratches on the massage ball:

There may be minor scratches on the massage ball resulting from normal use. These will not affect the efficacy of the laser treatment. Figure
32 shows a massage ball treatment head with a ball that has some minor scratches. If the scratches on the massage ball become significant,
then the massage ball treatment head should be replaced (see Figure 33).
To minimize scratches, make sure that you use a soft, non-fibrous wipe (e.g., Kimwipes
when cleaning the massage ball between patients. Do not wipe with a dry cloth: always dampen the cloth before wiping.
8.3.

Calibration Check Procedure

Regulatory agencies require that manufacturers of US FDA CDRH Class IIIb and IV laser products supply their customers with instructions
for verifying the measurement system within the laser meets the requirements of 21 CFR1040.11. 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: Adjustment to any internal components by anyone other than certified Service Personnel voids any existing
manufacturer's warranty on the Laser System.
Warning: ALWAYS wear laser safety goggles when performing the laser calibration check procedure and follow all laser safety
guidelines.
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 radiaition when open.
8.4.

Laser Power Calibration Check Instructions:

Equipment Needed: Certified traceable power meter and detector with appropriate wavelength and power measurement capabilities
Step 1. Turn off the laser.
Step 2. Inspect and attach optical fiber. 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 detector. 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.
9.

Quality and Regulatory

9.1.

Laser Product Regulations

The Companion ® laser system complies with 21 CFR Chapter 1, Subchapter J, as administered by the Center for Devices and Radiological
Health (CDRH) of the US Food and Drug Administration (FDA).
9.2.

Device Classification

According to the applicable standards, the laser system is classified as follows:

Class I Type B device per EN/IEC 60601-1

Class 4 laser product according to IEC 60825-1
In order to safely perform its intended use, the system requires the following Class I accessories:
RSR-000929-000 (0)
Figure 32
User Manual – CTX
Figure 33
®
) moistened with 70% isopropyl alcohol solution
Page 18 of 25