Frye Electronics, Inc. is a Registered Firm of British Standards
Institution, and we conform to the ISO 13485 standard.
Safety Classification for IEC 60601-1
Protection against electric shock—Class 1, Type B
Protection against harmful ingress of water—Ordinary
Mode of operation—Continuous
Warning: This equipment is not suitable for use in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide.
Warning: Connect only to the power supply packaged with the FP35.
Warning: To comply with IEC 60601-1, all electrical equipment attached to the
FP35 must also comply with these standards. Any video monitors, computer
equipment, etc. must be “medical grade” or used with a medical grade isolation
transformer.
1.7 Maintenance
We recommend checking the calibration of the FP35 analyzer once a year. See
Appendix C for details. Because of the configuration of the FP35, the micro-
phones should not go out of calibration. If you perform the checks described in
Appendix C and find that the microphones are in need of calibration, contact
your local service representative or Frye Electronics because this could be a sign
that further repairs to your system are needed.
When used in a hospital environment, where such test equipment is commonly
available, periodic current-leakage testing should be done on the power supply
while the FP35 is connected. Testing on a yearly basis is sufficient.
1.7.1 Servicing the Instrument
Contact Frye Electronics, Inc., P.O. Box 23391, Tigard, Oregon 97281-3391 for
service. Our toll-free number is 1-800-547-8209. Our regular number is (503)
620-2722, or you may contact your local Frye representative. We are also avail-
able on the internet. Our e-mail address is: service@frye.com, and our web site
is www.frye.com.
Units may be returned to Frye Electronics, Inc., 9826 S.W. Tigard St., Tigard,
Oregon 97223. Please contact the company or your local Frye representative
16 FONIX FP35 Hearing Aid Analyzer
