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Part Number - 00824 Revision K, DCO 2017-0074
© 2017 Thermedx
®
, LLC
Section 5 – Important Safety Information
The safe and effective use of surgical equipment is dependent, to a large degree, upon factors
solely under the control of the operator. There is no substitute for a properly trained and vigilant
operating room staff. It is important that the operating instructions supplied with this or any
other surgical equipment be read, understood, and followed.
WARNING
General Usage:
Read and follow all instructions, labeling, and accompanying documents supplied with this
medical device. Failure to follow instructions, including all warnings and cautions, could
lead to misuse of the device or device malfunction. Death or serious injury may occur to
the patient or user if these warnings are not followed.
Do not use the FluidSmart
®
in high-energy fields such as: MRI, X-RAY, portable and mobile
RF communications equipment, and other such devices. The FluidSmart
®
may act as a
projectile in a strong magnetic field, cause image artifacts, or not function as intended.
Do not operate the FluidSmart
®
in the presence of a flammable anesthetic mixture with
air, oxygen, or nitrous oxide. The risk of explosion exists if the FluidSmart
®
is operated in
a potentially explosive environment.
Exposed conductors on the power cord can cause an electrocution hazard. Remove device
from service if the power cord has exposed wires.
The power cord is to be used for mains disconnection.
Use only with a dedicated, properly grounded, 120 volt, 20 amp receptacle for P2000
model or 240 volt, 10 amp receptacle for W2100 model. Risk of electric shock exists if the
equipment is not connected to a properly grounded receptacle.
The tubing must be properly placed in the Bubble Detector. Failure to do so may result in
failure of the device to operate properly.
While the warming cartridge contains two bubble traps, the following are recommended
to further reduce the potential risk of an air embolism:
o
Remove and purge all air from fluid lines and instrument before using. Failure to
do so can result in infusion of air into the surgical site.
o
Ensure the tubing sets are fully primed with fluid prior to use, and that the
respective suction and irrigation lines are correctly attached.
o
Do not reuse partially full fluid bags. Fluid bags that have been partially drained,
un-spiked, and reinstalled may contain air, which if used can increase the risk of
introducing air into the surgical site. Use only new fluid bags from which the air
has been removed.
o
Ensure correct patient positioning.
o
Proper surveillance through the use of standard monitoring devices, such as
transesophageal echocardiography (TEE), precordial Doppler ultrasound, end-tital
CO2 monitoring, pulse oximetry, or other appropriate methods, is suggested as a
possible additional precaution, if deemed necessary by the physician for higher
risk procedures.
The FluidSmart
®
is for use only with Thermedx
®
supplied or approved parts, accessories,
and disposable sets. The device may not function as intended with the use of unapproved
parts, accessories, or disposable sets.
