Chapter 4. Warnings And Precautions - Adaptec Sensica UO Instructions For Use Manual

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
C 4. W
HAPTER ARNINGS AND
Read carefully before use.
General Warnings
Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put into
CAUTION
service according to the EMC information provided in the charts at the end of
these Instructions for Use.
Portable and mobile RF communications equipment can affect MEDICAL
CAUTION
ELECTICAL EQUIPMENT.
The Sensica UO System for ICU should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the Sensica UO
CAUTION
System for ICU should be observed to verify normal operation in the
configuration in which it will be used.
The Sensica UO System for ICU has a degree of protection against electric
shock of applied parts classified as Type BF. This device is classified as an IEC
CAUTION
Class 2 product.
To avoid the risk of electric shock, this equipment must be connected to a supply
CAUTION
mains with protective earth.
Do not immerse or submerge the Sensica UO Stand, Display Monitor or Ring in
water or other liquids. Do not pour liquids over the display monitor or ring. If
CAUTION
liquids accidentally spill onto device, wipe off liquid with soft cloth as soon as
possible. See Part III for complete care instructions.
This device is not suitable for use in the presence of flammable mixtures.
CAUTION
This device is not suitable for use in oxygen rich environments.
CAUTION
The use of transducers and cables other than those specified, with the exception
of transducers and cables sold by Adaptec Medical Devices as replacement
CAUTION
parts, may result in increased EMISSIONS or decreased IMMUNITY of the
Sensica UO System for ICU.
Operation Warnings
Federal law restricts this device to sale or use by or on the order of a licensed
CAUTION
physician.
The Sensica UO System for ICU should only be used on the request by and
CAUTION
under the direction of a licensed physician.
Do not use Sensica UO Ring (disposable) if product appears broken.
CAUTION
The "Load Cell Self-Test" should be performed prior to first use, when there is a
question about system accuracy, and after any servicing or repairs to ensure
CAUTION
accurate measurements. If the load cell self-test fails, re-test with different
P/N 005-0175 Rev A
P
RECAUTIONS
Adaptec Medical Devices 22