-6-
LIFEWARMER
™
PRESCRIBING INFORMATION
INDICATIONS FOR USE:
The Quantum™ Blood & Fluid Warming System is indicated for warming blood, blood products and intravenous
solutions prior to administration in adult patients. It is intended for use by healthcare professionals in hospital, clinical,
eld and transport environments to help prevent hypothermia.
WARNINGS:
• For the safe operation of the Quantum System,
all instructions, warnings and precautions
in this document must be followed. Failure
to follow instructions for proper use may
result in device malfunction or injury.
• Only the uid path and areas under protective
end caps are STERILE. If end protectors
are not in place, DO NOT USE.
• DO NOT place tubing sets or protective
end caps in a sterile eld.
• The TIS/TTS-B is for SINGLE PATIENT USE ONLY.
DO NOT RESTERILIZE.
• The Quantum Thermal Infusion Set (TIS) IS NOT
for standalone use with blood or blood products.
• A RED LED strobe and sustained audible alert on the
battery indicates a uid over-temperature condition
which can result in hemolysis of blood and elevation
of touch temperature of the thermal tubing.
• The over-temperature Audible Alert System
may be manually disabled. Ensure that the
Audible Alert System is always enabled
unless a tactical hazard is posed.
• Replace Quantum Transfusion (TTS-B) and Infusion
Sets (TIS) in accordance with CURRENT AABB/
CDC guidelines and/or institutional protocols.
• All IV uid bags must be vented of air per IV uid
manufacturers’ directions prior to connecting to tubing
set. Care must be taken to ensure there is not sucient
air in the uid bag and lines to cause an air embolism.
• DO NOT ax, place or bind the thermal (heated)
portion of the thermal tubing directly to a patient.
• It is recommended that the Controller, Battery, and
Charger be surfaced cleaned and disinfected after
each patient use following the instructions in this
manual or according to standard institutional protocol.
• DO NOT touch the Battery pins and
the patient at the same time.
• Warning: Use of this equipment adjacent to or
stacked with other equipment should be avoided
because it could result in improper operation. If
such use is necessary, this equipment and the other
equipment should be observed to verify that they are
operating normally.
• The Quantum System (including Thermal
Tubing TIS and TTS-B) is MR UNSAFE .
• The Quantum is intended for gravity administration.
However, performance testing has been
conducted in accordance with ISO 1135-5 for
single use transfusion sets with pressure infusion
and found to be mechanically stable. Thus,
the clinician may apply reasonable pressure
to the infusate bag if it is determined that
increased uid ow is clinically indicated.
• DO NOT attempt to use the Quantum System
components, including tubing sets (TIS,
TTS-B), Controller, Battery, or Charger with
uid warming devices/components from other
manufacturers. They are not compatible.
• DO NOT attempt to use charging devices, power
cables or components from other manufacturers
with the Quantum System components. They
are not compatible and pose a safety hazard.
• DO NOT attempt to sterilize, autoclave
or submerge the Controller, Battery, or
Charger. Surface clean/disinfect only.
• There are no user-serviceable parts including the
Battery. For all matters concerning functionality
and service, contact Life Warmer, Inc.
• DO NOT attempt to open or access the
Controller, Battery, or Charger. Doing so may
damage the components and/or result in
device malfunction, failure or injury.
• DO NOT attempt to modify any component
of the Quantum System. There may be NO
changes or modications to the mechanics,
electronics, and/or software of the system.
• DO NOT operate or store Quantum components
outside of the specied environmental
limits. A safety hazard may occur.
• DO NOT use a multiple socket outlet or extension
cord with any Quantum component.
• Degradation of sensors can result in inaccurate
temperature readings and subsequent
outow temperatures. If this occurs, the
Controller will indicate a System Error.
