Appendix - Emc Guidance & Manufacturer's Declaration; Electromagnetic Compatibility - Welch Allyn MICROTYMP 4 User Manual

Hand held portable tympanometer
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Welch Allyn MicroTymp® 4 Tympanometer User Manual
A
- EMC G
PPENDIX
Portable and Mobile RF communications equipment can affect the Welch Allyn MicroTymp 4.
Install and operate the Welch Allyn MicroTymp 4 according to the EMC information presented in
this appendix and in EMC Tables available at www.welchallyn.com/emc-mt4.
The Welch Allyn MicroTymp 4 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.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the MicroTymp
4, including cables specified by the manufacturer. Otherwise, degradation of the performance of
this equipment could result.
The use of accessories, transducers and cables other than those specified, with the exception of
servicing parts sold by Welch Allyn 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.
E
C
LECTROMAGNETIC
OMPATIBILITY
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.
E
S
, EMC
LECTRICAL
AFETY
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 60601-1-1: 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 European Union Medical Device Directive 93/42/EEC
RoHS (Restriction of the use of certain Hazardous Substance)
DIR 80024157 Ver A
& M
UIDANCE
ANUFACTURER
A
S
AND
SSOCIATED
'
D
S
ECLARATION
TANDARDS
Page 45

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