Electromagnetic Compatibility (Emc) - Zeiss Humphrey II-i series User Manual

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HFA Instrument
Appliance Coupler
(input power plug)
Introduction & Instrument Setup
WARNING: If the instrument is externally connected to non-medical peripheral
devices (i.e. printer, storage devices, etc.), the complete system must comply with the
system requirements in standard IEC 60601-1. This standard requires the usage of an
Isolation Transformer to power the non-medical peripheral device(s) if located within
1.5 m from the patient. If the peripheral device is located outside the patient
environment (beyond 1.5 m) and is connected to the HFA, a separation device must
be used or there shall be no metal to metal connection between the non-medical
peripheral device and the HFA.
The person or the responsible organization connecting additional devices or
reconfiguring the system must evaluate the complete system to ensure compliance to
the applicable IEC 60601-1 requirements. The instrument operator must not attempt
to touch the patient and the peripheral device simultaneously.
WARNING: Do not reconfigure system components on the table, nor add non-system
devices or components to the table, nor replace original system components with
substitutes not approved by Carl Zeiss Meditec. Such actions could result in failure of
the table height adjustment mechanism, instability of the table, tipping and damage
to the instrument, and injury to operator and patient.
CAUTION: The appliance coupler (shown on the left) is the main disconnect device of
the instrument. Position the instrument in such a way to have easy access to
disconnect the appliance coupler in case of an emergency.
CAUTION: In case of an emergency, disconnect the appliance coupler.
WARNING: This instrument may cause ignition of flammable gases or vapors. Do NOT
use in the presence of flammable anesthetics such as nitrous oxide, or in the presence
of pure oxygen.
WARNING: Avoid tipping. Do not use the instrument on an uneven or sloped surface.
Do not roll the table in deep pile carpet or over objects on the floor such as power
cords. Failure to observe these precautions could result in tipping of the instrument
and/or table and resulting injury to operator or patient and damage to the
instrument.

Electromagnetic Compatibility (EMC)

i
Note: The HFA II- needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided herein.
Note: Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING: The use of accessories, transducers and cables other than those specified
may result in increased emissions or decreased immunity of the equipment.
WARNING: The HFA II-i should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the equipment or system should
be observed to verify normal operation in the configuration in which it will be used.
Humphrey Field Analyzer II- i series User Manual 2660021145640 A