Lifewarmer Quantum - Quantum System Description

-8-
LIFEWARMER
™
INTENDED USERS &
USE ENVIRONMENTS
Intended Users:
Operators of the Quantum should be knowledgeable in the use of IV administration sets for infusion of uids and
transfusion of blood/blood products. The Quantum thermal tubing sets (TIS and TTS-B) deliver IV solutions and
blood/blood products in a similar manner as conventional IV infusion and transfusion sets.The Quantum is designed for
quick set up and deployment using minimal steps. Intended users include military medics, EMS Paramedics, registered
nurses, physicians and mid-level practitioners. Patient-users of the Quantum include any adult patient presenting with
the need for IV solutions, blood or blood products who may benet from warmed uids..
Intended Use Environments:
The Quantum Blood & Fluid Warming System is transportable. The intended use environments include hospitals (e.g.,
in-patient/full services facilities), clinical environments (e.g., satellite emergency centers, outpatient centers, etc.),
and eld environments (e.g., point of injury including civilian and battleeld locations) and transport environments
such as emergency vehicles en route (i.e., xed and rotary wing aircraft and ground and air ambulance). The Quantum
Controller, Battery, TIS/TTS-B are intended for use in the Patient Environment. Note: The Battery Charger should only
be used in hospital and protected xed structure environments.
QUANTUM SYSTEM DESCRIPTION:
Device Description:
The Quantum Blood & Fluid Warming System is a lightweight, battery powered, highly portable, uid warming system
in which the warming element is integrated with specially designed intravascular administration tubing. Fluid warming
is achieved in the tubing through the use of proprietary thermoplastic polyurethane and a software control .algorithm.
The Quantum IV administration
tubing is double-extruded to yield a
conguration that has both an inner
tubing layer and an outer tubing
layer. A conductive heating element
is between the two layers but does
not come in contact with the uid
path [Figure 1]. The outer tubing layer
acts as an insulator while the inner
tubing layer transfers the heat from
the heating element to the uid path.
The Quantum System, fully charged,
is able to warm and maintain up to
2 units ( 900mL +/- 100mL) of cold
(4ºC) blood products or IV solutions to a pre-set temperature of 38ºC ± 2ºC (100.4ºF ± 2) at a ow rate of 100 mL/min
(depending on the ambient temperature). Or, approximately 1700 mL of 20ºC IV solution to a set point of 38ºC +/- 2ºC
at a ow rate of 200 mL/min. Eective warming ow rates range from 2 to 200 mL/minute depending on input uid
temperature and ambient conditions.
Thermistors located in the tubing continually measure temperature and provide that input to the Controller. The
Controller assesses the temperature input and regulates the amount of energy applied to the heating element needed
to reach and maintain a constant uid temperature. The monitoring and independent application of energy (heat) along
the uid path allows the Quantum to respond to varying temperature inputs from the uid source to near the point of
patient entry to ensure uid temperature is ≥ 36ºC to < 44ºC at delivery.
The Quantum is powered by a rechargeable lithium-polymer battery. The complete Quantum Blood & Fluid Warming
System, including the Battery, weighs less than 1,5 lbs. and can travel with the patient across multiple clinical use
environments while maintaining optimum uid temperature.
Outer tubing
Figure 1:
Quantum Tubing
C
ross Section
Heating element
B inding layer securing
the heating element
In ne r tu bi ng (co n du ct s
sterile uid path and
absorbs heat)