Cautions - General
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.
Warning - Connecting Additional Equipment
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 collateral standard IEC 60601-1-1 or 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.
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
qualified medical technician or your local representative.
A Separation Device (isolation device) is needed to isolate the equipment located
outside the patient environment from the equipment located inside the patient
environment. In particular such a Separation Device is required when a network
connection is made. The requirement for the Separation Device is defined in IEC
60601-1-1 and in IEC 60601-1, edition 3, clause 16.
The AC power outlets on the isolated transformer/power box are intended for use
with GSI approved components only. Use of any other equipment may result in
damage to the power unit. Follow all safety standards set by each place of
employment.
NOTE:
If the instrument is connected to a PC, power to the monitor and
computer must be controlled by the isolation transformer. Always leave the
monitor and computer power switches in the ON position and control power from
the isolation transformer. Always turn OFF system power before connecting or
disconnecting system components to help guard against personal injury.
Warning - Electric Shock Hazards
Do not open the case of the GSI Instrument. Do not remove any GSI instrument
covers. Refer servicing to qualified personnel.