Before the first use of the instrument each day, or if suspect or inconsistent results are
apparent, the checks specified in the Routine Maintenance section should be carried out. If
the system is not functioning properly, do not operate it until all necessary repairs are
made and the unit is tested and calibrated for proper functioning in accordance with
Grason-Stadler published specifications.
No parts of the equipment can be serviced or maintained while in use with the patient.
Latex is not used anywhere in the manufacturing process. The base material for the
earphone cushions is made from natural and synthetic rubber.
Fluids
The device is not intended to be used in environments exposed to fluid spills.
No means is specified for fluid protection (not IP classed). Do not use the
device in the presence of fluid that can contact any of the electronic
components or wiring. Should the user suspect fluids have contacted the
system components or accessories, the unit should not be used until deemed safe by an
authorized service technician. Do not immerse the unit in any fluids. See the Routine
Maintenance Section of this manual for the proper cleaning procedure for the instrument
and its accessories and the function of single-use parts.
Damage
Do not drop or otherwise impact this instrument. If the instrument is dropped
or damaged, return it to the manufacturer for repair and/or calibration. Do
not use the instrument if any damage is suspected.
Do not attempt to open, modify or service the instrument. Return the instrument to the
manufacturer or distributor for all repair and servicing requirements. Opening the
instrument will void the warranty. See Warranty and Repair in the Appendix
Connecting Additional Equipment
This equipment is intended to be connected to other equipment thus forming
a Medical Electrical System. External equipment intended for connection to
signal input, signal output or other connectors shall comply with the relevant
product standard e.g., IEC 60950-1 for IT equipment and the IEC 60601-series
for medical electrical equipment. In addition, all such combinations – Medical Electrical
Systems – shall comply with the safety requirements stated in the general standard IEC
60601-1, edition 3, clause 16. Any equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the patient environment i.e., at least 1.5
m from the patient support or shall be supplied via a separation transformer to reduce the
leakage currents.
D-0131088 Rev C, 2022-07
GSI AudioStar Pro Instructions for Use
Page 12 of 84