Frye Electronics FONIX COLT Audiometer
3
%
90%
5%
The shipping/storage humidity of the Colt Audiometer is 5 to 90% relative
humidity (non-condensing).
This symbol on the insert earphone eartip packaging indicates that eartips
should be discarded after use in order to prevent the possible spread of
infection. They cannot be cleaned, sterilized, or reused.
This symbol indicates that Frye Electronics, Inc. conforms to the
Medical Device Directive 93/42/EEC. Any attached external computer or
other electrical device should also have a CE mark in order for the Colt Audi-
ometer to remain compliant.
Safety Classification for IEC 60601-1
Type of protection against electric shock: Class I
Degree of protection against electric shock: Type B
Protection against harmful ingress of water: IPX0
Mode of operation: Continuous
The Colt Audiometer does not require sterilization or disinfection.
Warning: This equipment is not suitable for use in the presence of flammable anaesthetic
mixture with air or with oxygen or nitrous oxide.
Warning: To avoid the risk of electric shock, this equipment must only be connected to a sup-
ply mains with protective earth.
Warning: Do not touch the contacts of connectors and the patient simultaneously.
The Colt base unit and attached accessories may be used within the patient environment. The
android tablet may also be used within the patient environment, except when it is connected
to mains power. The android tablet should be kept out of the patient environment, while it is
being charged.
Connection of peripheral equipment to the Colt Audiometer
All electrical equipment attached to the Colt Audiometer, such as audio equipment, computer
equipment, etc. must, at a minimum, meet one of the following conditions:
a. The equipment complies with IEC 60601-1
b. The equipment complies with relevant IEC and ISO safety standards and is supplied
from a medical grade isolation transformer.
c. The equipment complies with relevant IEC and ISO safety standards and is kept at
least 1.5 meters from the patient.
