APPENDIX 3 – USE WITH NON-MEDICAL EQUIPMENT
45
OM033-4 - CA850 Series 5 Operating Manual
APPENDIX 3 – USE WITH NON-MEDICAL EQUIPMENT
Any person who connects external equipment to signal input, signal output or other connectors has created a
medical electrical system and is therefore responsible for the system complying with the requirements of
clause 16 of IEC 60601-1:2005
(General requirements for basic safety and essential performance).
If connections are made to standard equipment such as printers and computers, special precautions must be
taken in order to maintain medical safety. The following notes are provided for guidance in making such
connections to ensure that the general requirements of clause 16 of IEC 60601-1:2005 are met.
The following signal inputs and outputs on the CA850 audiometer are specified for user connections and are
electrically isolated to the requirements of IEC 60601-1 in order to reduce any potential hazard associated
with the use of mains-powered equipment connected to these inputs and outputs:
Socket
Identification
Socket Type
Socket Function
Typical
Connection
USB
PRINTER
USB Type A
(Master)
USB device
connection
Printer
USB Drive
USB
PC
USB Type B
(Slave)
USB device
connection
Computer
External equipment intended for connection to signal input, signal output or other connectors, shall comply
with the relevant IEC or international standards (e.g. IEC 60950, CISPR 22 & CISPR 24 for IT equipment, and
the IEC 60601 series for medical electrical equipment).
Equipment not complying with IEC 60601 shall be kept outside the patient environment, as defined in IEC
60601-1 (at least 1.5m from the patient).
The operator must not touch the connected equipment and the patient at the same time as this would result
in an unacceptable hazard.
Refer to Section 4 of this operating manual for a typical test arrangement and to Diagrams 1 to 3 below for
example configurations of connected peripheral equipment. Refer to Amplivox Limited at the address given
on the front of this user manual if advice is required regarding the use of peripheral equipment.
Diagram 1: CA850 used with the medically-approved mains adapter
Mains Outlet
Medical Mains Adapter
CA850
Audiometer
