Indications For Use Cautions; Training Requirements; Electromagnetic Compatibility; Emc Warnings - GE CARESCAPE ONE User Manual

CARESCAPE ONE User Manual DRAFT 26 October 2017
Safety
WARNING

Indications for use cautions

CAUTION
CAUTION

Training requirements

No product-specific training is required for the use of the CARESCAPE ONE.

Electromagnetic compatibility

EMC warnings

WARNING
WARNING
WARNING
WARNING
34
INTRAHOSPITAL TRANSPORT. Vibrations during intrahospital
transport may disturb SpO
and IP measurements.
U.S. Federal law restricts this device to sale by or on the order
of a physician.
SUPERVISED USE. This equipment is intended for use under
the direct supervision of a licensed healthcare practitioner.
Use only approved accessories, including mounts, and
defibrillator-proof cables and invasive pressure transducers.
For a list of approved accessories, see the supplemental
information provided. Other cables, transducers and
accessories may cause a safety hazard, damage the
equipment or system, result in increased emissions or
decreased immunity of the equipment or system, or interfere
with the measurement.
Pins of connectors identified with the ESD warning symbol
should not be touched. Connections should not be made
to these connectors unless electrostatic discharge (ESD)
precautions are used.
Do not use the device in high electromagnetic fields (for
example, during magnetic resonance imaging).
EMC. Magnetic and electrical fields are capable of interfering
with the proper performance of the device. For this reason
make sure that all external devices operated in the vicinity of
the monitor comply with the relevant EMC requirements. X-ray
equipment or MRI devices are a possible source of interference
as they may emit higher levels of electromagnetic radiation.
Changes or modifications to this device/system not expressly
approved by GE may cause EMC issues with this or other
equipment. This device/system is designed and tested to
comply with applicable standards and regulations regarding
EMC and needs to be installed and put into service according
to the EMC information stated as follows: This device/system
is suitable for use in all establishments other than domestic
and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes. Mains power should be that of a typical commercial
or hospital environment. Device is compliant to Class A.
CARESCAPE ONE
, ECG, impedance respiration, NIBP,
2
2094480-001