User manual

FastSCAN 53

• Operate the device so that it is pointing away from windows, doors, mirrors and

other shiny reﬂective surfaces, and areas where other people are working.

• There are no controls, adjustments or user serviceable parts that can affect the

laser output. In the event of equipment failure, return the Wand to the manufac-

turer or agent for repair and servicing.

The product includes the following safety features:

• The laser is only activated when the spring-loaded trigger is depressed.

• An indicator light is illuminated when the laser is operating.

• All controls can be operated without direct viewing of the beam.

• Warning labels and a label indicating the laser aperture are attached to the Wand

in the positions indicated on the following ﬁgures in Section 12.4: Warning La-

bels and Locations (overleaf):

Caution: Use of controls and adjustments, or performance of procedures other than

those speciﬁed in this manual may result in hazardous laser radiation exposure.

12.3 Use for Medical Applications

Polhemus is a Good Manufacturing Practices (GMP) Contract Manufacturer under

U.S. FDA Regulations. We are not a manufacturer of Medical Devices. Polhemus sys-

tems are not certiﬁed for medical or bio-medical use. Any references to medical or

bio-medical use are examples of what medical companies have done with the Prod-

ucts after they have obtained all necessary or appropriate medical certiﬁcations. The

end user/OEM/VAR must comply with all pertinent FDA/CE regulations pertaining

to the development and sale of medical devices and all other regulatory requirements.