Annex 1. Main Specifications
41
Table 3 (continued)
Parameter
Value
Conformance to technical standards
Reference zero for calibration of audiometric
equipment
EN ISO 389-1:2000
EN ISO 389-2:1996
EN ISO 389-3:2016
EN ISO 389-5:2006
EN ISO 389-6:2007
EN ISO 389-8:2004
Stimulus types
EN 60645-1:2015
EN 60645-3:2007
Tone audiometry (P
Т
A)
EN 60645-1:2015 (Type 4)
Otoacoustic emission (OAE)
EN 60645-6:2010 (Type 1)
Auditory brain response (ABR)
EN 60645-7:2010 (Type 1)
Essential Performance Requirements
The essential performance requirements for the system are:
·
stimulus generation and delivery via earphones (or other acoustic transducer);
stimulus parameters must comply with EN 60645 standards, mentioned in Table 4;
·
recording and storage of patient’s response to stimulus.
The correct operation of the system means that the requirements are fulfilled.
Safety and Electromagnetic Compatibility
Electromagnetic compatibility (EMC) is ensured by compliance with EN 60601-1-
2:2015 requirements.
The system is intended for operation in the electromagnetic environment conditions
which are specified in Annex 3 “Electromagnetic Emission and Immunity”.
Do not use the system when other equipment is under or above it or when the system
in close proximity to other equipment. However, if it is required, the correct operation
of the system should be verified.
Portable and mobile RF communication equipment can affect the system work. Do not
use these devices less than 30 cm from any part of the system (including the cables)
to avoid incorrect operation.
The use of the equipment not listed in Table 5 and Table 6 of this technical manual
may result in increase of emission and reduce of immunity of the system.
As for safety, the system complies with EN 60601-1:2006/A1:2013 requirements.
The electronic units are supplied by regulated power supply through USB interface,
have double isolation and BF type applied parts according to EN 60601-
1:2006/A1:2013.