6 Device application specification
6.1 Description
The device is a transportable, hand-held and battery powered medical laser with which the operator administers non-invasive laser
light/radiation to a patient.
6.1.1 Expected life before service required
Three to four years.
6.2 Medical purpose/intended use
Intended to reduce pain and inflammation, Parkinson’s and Fibromyalgia symptoms, as well as to promote tissue repair.
6.3 Patient
Human.
6.4 Operator
Ordinary and patient operators:
- An ordinary operator is a medically trained practitioner who uses medical lasers in his or her day-to-day practice; and
- A patient operator uses the device according to the accompanying documents (this manual) for home care self-treatment with
guidance or instruction from a non-present ordinary operator.
6.5 Application
Contact application on intact skin and skin around orifices.
Caution/warning: Never to be applied on eyes, eyelids or used for treatments through the lens of the eye, including intra-beam
viewing.
6.6 Environment
Indoors, 10 - 90 % atmospheric humidity at temperatures ranging from +5 - 30° C and at air pressure of 700 -1060 hPa.
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