GSi TYMPSTAR PRO, User Manual

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Appendix 4: Safety, EMC and Associated Standards
Portable and Mobile RF communications equipment can affect the TympStar
Pro. Install and operate the TympStar Pro according to the EMC information
presented on this appendix.
The TympStar Pro has been tested for EMC emissions and immunity as a
standalone instrument. Do not use the TympStar Pro 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
1. UL 60601-1: Medical Electrical Equipment, Part 1 General
Requirements for Safety
2. IEC/EN 60601-1: Medical Electrical Equipment, Part 1 General
Requirements for Safety
3. CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment, Part 1
General Requirements for Safety Electrical Equipment for Laboratory
Use
4. IEC/EN 60601-1-1: Collateral Standard, Safety Requirements for
Medical Electrical Systems
5. IEC/EN 60601-1-2: Medical Electrical Equipment, Part 1 -
Electromagnetic Compatibility - Requirements and Tests
6. Essential Requirements of the current European Union Medical Device
Directive 93/42/EEC
7. RoHS (Restriction of the use of certain Hazardous Substance)
8. WEEE (Waste Electrical & Electronic Equipment) Legislation