FONIX® 8000 - Frye Electronics

14 FONIX 8000 Hearing Aid Test System
5%
Probe Tubes
%
90%
The shipping/storage Humidity of the 8000 is 5 to 90
percent relative humidity (non-condensing)
This symbol, included on the probe tube packaging, indicates
that probe tubes should be discarded after use in order to prevent
the possible spread of infection. They cannot be cleaned,
sterilized, or reused.
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: Ordinary
Mode of operation: Continuous
The 8000 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 supply mains with protective earth.
Warning: Do not touch the contacts of connectors and the patient simultaneously.
Connection of peripheral equipment to the 8000
Compliance with IEC 60601-1: 2005 Safety requirements for medical electrical
systems must be determined on a case-by-case basis.
All electrical equipment attached to the 8000, such as video monitors, 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.
The allowable leakage currents of IEC 60601-1: 2005 must not be exceeded. IEC
60601-1: 2005 should be consulted when assembling such a system. Failure to
comply with these instructions could lead to interference with nearby medical
equipment.