46 Maintenance Manual
8.2 Safety Classification for IEC 60601-1
Type of protection against electric shock: Class 1
Degree of protection against electric shock: Type B
Protection against harmful ingress of water: IPX0
Mode of operation: Continuous
The 8000 does not require sterilization or disinfection.
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: To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth. Turning the power switch to the off position
or disconnecting the power cord isolates the 8000 from the supply mains.
Warning: Do not touch the contacts of connectors and the patient simultaneously.
Warning: Do not modify this equipment without authorization of the manufacturer.
8.3 Connection of peripheral equipment to the 8000
Compliance with IEC 60601-1: 2005 Safety requirements for medical electrical sys-
tems 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:
1. The equipment complies with IEC 60601-1
2. The equipment complies with relevant IEC and ISO safety standards and is
supplied from a medical grade isolation transformer.
3. 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.
The FONIX 8000 Test System is equipped with USB and RS232 connections that will
allow you to connect to a personal computer and exchange data. You will also
need a software program, such as WinCHAP, on your Windows computer that can
communicate with the analyzer. It is possible to make your own program using the
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