GSI
Allegro Tympanometer
User Manual
D-0120695 Rev D 2022-06 Page 45
APPENDIX - EMC GUIDANCE & MANUFACTURER’S DECLARATION
Portable and Mobile RF communications equipment can affect the GSI Allegro. Install and
operate the GSI Allegro according to the EMC information presented in this appendix.
The GSI Allegro has been tested for EMC emissions and immunity as a standalone instrument. Do
not use the device adjacent to or stacked with other electronic equipment. If adjacent or stacked
use is necessary, the user should verify normal operation in the configuration.
The use of accessories, transducers and cables other than those specified, with the exception of
servicing parts sold by GSI as replacement parts for internal components, may result in increased
EMISSIONS or decreased IMMUNITY of the device. Anyone connecting additional equipment is
responsible for making sure the system complies with the IEC 60601-1-2 standard.
ELECTROMAGNETIC COMPATIBILITY
Although the instrument fulfils the relevant EMC requirements precautions should be taken to
avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones, etc. If the device
is used adjacent to other equipment it must be observed that no mutual disturbance appears.
ELECTRICAL SAFETY, EMC AND ASSOCIATED STANDARDS
UL 60601-1: Medical Electrical Equipment, Part 1 General Requirements for Safety
IEC/EN 60601-1: Medical Electrical Equipment, Part 1 General Requirements for Safety
CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment, Part 1 General Requirements for
Safety Electrical Equipment for Laboratory Use
IEC/EN 60601-1: Collateral Standard, Safety Requirements for Medical Electrical Systems
IEC/EN 60601-1-2: Medical Electrical Equipment, Part 1 - Electromagnetic Compatibility -
Requirements and Tests
Essential Requirements of the current
Medical Device Regulation (EU) 2017/745
RoHS (Restriction of the use of certain Hazardous Substance)
WEEE (Waste Electrical & Electronic Equipment) Legislation
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