GSi AUDIOSTAR PRO Manuel D'instructions page 18

Any person who connects external equipment to signal input, signal output or other
connectors has formed a Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact a qualified medical technician
or your local representative. If the instrument is connected to a PC (IT equipment forming
a system) ensure not to touch the patient while operating the PC. If the instrument is
connected to a PC (IT equipment forming a system) assembly and modifications shall be
evaluated by qualified medical technician according to safety regulations in IEC 60601.
EXPLOSION
This system is not explosion proof.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device near
flammable anesthetic gases.
Do NOT use the system in a highly oxygen-enriched environment, such as a hyperbaric
chamber, oxygen tent, etc.
ENVIRONMENTAL FACTORS
Use and store the instrument indoors only. It is recommended that the
instrument be operated within an ambient temperature range of 15 °C / 59 °F
to 35 °C / 95 °F and in relative humidity between 30 % and 90 % (non-
condensing).
Transport the instrument in temperatures between 20 °C / -4 °F to +50 °C / +122 °F and
store the instrument in temperatures between 0 °C / 32 °F to 50 °C / 122 °F.
ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS
Medical electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information in the Appendix. Although
the instrument fulfills the relevant EMC requirements, precautions should be taken to
avoid unnecessary exposure to electromagnetic fields, e.g., from mobile phones etc. This
appendix provides guidance on the electromagnetic environment in which to operate the
instrument.
Portable and mobile radio frequency (RF) communications equipment can affect medical
electrical equipment. Use of this instrument adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is necessary,
this instrument and the other equipment should be observed to verify that they are
operating normally.
D-0131088 Rev C, 2022-07
GSI AudioStar Pro Instructions for Use
Page 13 of 84