THOR PHOTOMEDICINE LTD

Additional Manufacturer Narrative

TESTING OF THE 1W LASER CLUSTER PROBE DID NOT FIND ANY FAULTS WITH THE PROBE. THOR HAS DONE A PROBE TEMPERATURE TEST, RUNNING THE PROBE FOR 10 MINUTES. AT 0 SEC, THE PROBE TEMPERATURE MEASURED 21.4 DEGREES C, AT 1 MIN IT HAD REACHED 21.4 DEGREES C, AT 10 MINS IT MEASURED 28.2 DEGREES C.

Description of Event or Problem

USED ON PATIENT'S POSTERIOR NECK FOR 3 MINUTES ON ONE SIDE OF THE NECK, TOOK A 5 MINUTE BREAK, TREATED OTHER SIDE - THE PROBE GOT VERY HOT AFTER 2 MINUTES. NO BURNS OR POST LASER IRRITATION REPORTED. PRACTITIONER USED IT THAT EVENING ON THEIR ABDOMEN, PROBE GOT HOT AFTER 90 SECONDS. AFTER NOT USING IT FOR A WEEK, PRACTTIONER USED IT OVER THEIR KNEE FOR 3 MINUTES, PROBE DID NOT GET HOT.