37
D-0116492-B (OM022)
– Otosure Operating Manual
11.
USE WITH NON-MEDICAL ELECTRICAL 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 Amplivox Otosure audiometer are electrically isolated to the
requirements of IEC 60601-1 in order to reduce any potential hazard associated with the use of connected
mains-powered equipment:
Socket
Label
Socket Type
Typical
Connection
USB Connector
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 the diagram below for a typical configuration of a connected computer. Refer to Amplivox Ltd at the
address given on the front of this user manual if advice is required regarding the use of peripheral
equipment.
Otosure used with a PC via a USB connection
Otosure Audiometer
Mains Outlet
PC via
USB Socket
PC Power Supply
Summary of Contents for Otosure
Page 1: ...Otosure Operating Manual...
