Lifewarmer Quantum User manual

Blood & Fluid Warming System
™
™
___________________________
USER MANUAL
Distributed by
35 Tedwall Ct. • Greer SC 29650 • USA

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CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a physician.
It is important that users read and understand all information contained in this
manual concerning the intended use and proper operation of the Quantum
Blodd & Fluid Warming System. This manual is not intended as a substitute for
formal training in the use of intravenous administration systems, which may be
required by local, regional, or state protocol. Consult your local medical director
or governing agency for further information and requirements. For questions
concerning this manual or the device, contact Life Warmer, Inc.
Contact Us:
If you have questions regarding the use of the Quantum Blood and Fluid
Warming System or any component, please contact North American Rescue at
888-689-6277.
ZZ-1098 • REV050619
Blood & Fluid Warming System
™
™
Distributed by
35 Tedwall Ct. • Greer SC 29650 • USA
USA
Life Warmer, Inc
Addison, TX 75001
972-908-9808
[e-mail]

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LIFEWARMER
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Symbol Reference Title/Meaning
ISO-2492 Batch Code/
Manufacturer’s Lot
ISO 7000-1051 Do Not Reuse
ISO 7000-3832 Gravity type
EN 50419
WEEE wheeled bin
Recyle electronic equipment;
Do Not Throw in Trash
ISO 7000-043A Caution
ISO 15223 –
5.4.5
Not made with natural rubber
latex
ISO 7000-1641 Operating Instructions; eIFU
ISO 7010-M002 Follow Instructions for Use
ISO 7000-2724 Non-pyrogenic
ISO 7000-3079 Open here
ISO 7000-2608 Do not resterilize
ISO 7000-0632 Temperature limits; Limits for
safe device exposure
ISO 7000-2621
Atmospheric pressure
limitation; Range which device
can be safely exposed
MDD
93/42/EEC
CE Marks
Signies European technical
conformity
IEC 60086-4 DO NOT disassemble
(battery)
IEC 60086-4 Do NOT incinerate
(battery)
STERILIZE
2
Symbol Reference Title/Meaning
ISO 7000-
2493 Catalogue Number
ISO 7000-
2607
Use-by date;
Date after which the device is
not to be used
21 CFR Part
801.109
Caution: Federal (USA) law
restricts this device to sale byor
on the order of a physician
ASTM F-2503
MR Unsafe;
Device known to pose hazards in
all MR environments
IEC 60417-
5333 Type BF Applied Part
BS EN 15986-
4.2
Non-DEHP
Does not contain the phthalate
plasticizer DEHP
ISO 7000-
2501 Sterilized using ethylene oxide
ISO 7000-
3082 Device Manufacturer
ISO 7000-
2497 Date of manufacture
ISO 7000-
6049 Country of manufacture
ISO 7000-
2726 Number of drops per mllilitre
ISO 7000-
2620
Humidity limitation;
Range which medical device can
be safely exposed
BS/EN 1041 Authorized representative in the
European country
N/A
Global Trade Identication
Number; denotes proximate UDI
barcode
IEC 60086-4 Do NOT crush
(battery)
REF
20
EC REP
GLOSSARY OF SYMBOLS
The following symbols may appear on components or in information related to the Quantum device.

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LIFEWARMER
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TABLE OF CONTENTS
Prescribing Information
Indications for Use .........................................................................................................................6
Warnings ..........................................................................................................................................6-7
Precautions ..........................................................................................................................................7
Intended Users & Use Environments ......................................................................................8
Quantum System Description
Device Description ........................................................................................................................9
Quantum System Components ..........................................................................................9
Quantum System Operation
Thermal Infusion Set (TIS) .................................................................................................... 10
Thermal Transfusion Set (TTS-B) .................................................................................... 11
Charging/Connecting the Battery ................................................................................ 12
• Charging the Battery .................................................................................................... 12
• Checking Battery Charge Status ........................................................................ 12
• Connecting the Battery to the Controller ................................................... 12
• Important Battery Use Information .................................................................. 12
Connecting the Controller ....................................................................................................13
• Connecting the Controller to the TIS or TTS-B Tubing .....................13
• Disconnecting Components/Discontinuing Use ..................................13
Enabling/DIsabling Audible Alert System ...............................................................14
Instructions for Performing Manual Test of Audible Alert ...........................14
Sterility Status .........................................................................................................................................15
Sterile Components....................................................................................................................15
Single-Patient Use and Non-Sterile Reusable Components ...................15
Cleaning and Disinfecting ............................................................................................................15
Visual/Audio Indicators
User interface: Table of visual and audio indicators ................................ 16-17
Technical Specications ........................................................................................................18-19
Essential Performance .............................................................................................................18
System Information/Safety Classication ................................................................18
Performance .....................................................................................................................................18
Component Specications .................................................................................................. 19
Operating, Storage & Distribution Conditions ...........................................................20
EMC Compliance Statement .......................................................................................................21
APPENDIX ....................................................................................................................................................22
Troubleshooting Guide .................................................................................................. 22-23
Quantum Response by Temperature Table ...........................................................23
Glossary of Terms .......................................................................................................................24
Quantum Components List .........................................................................................24-25
Warranty .............................................................................................................................................26

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LIFEWARMER
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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 sucient
air in the uid bag and lines to cause an air embolism.
• DO NOT ax, 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 modications to the mechanics,
electronics, and/or software of the system.
• DO NOT operate or store Quantum components
outside of the specied 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
outow temperatures. If this occurs, the
Controller will indicate a System Error.

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LIFEWARMER
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PRESCRIBING INFORMATION (continued)
WARNINGS: (continued)
• Use of accessories, transducers and cables other than
those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of
this equipment and result in improper operation.
• Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas) should be used no closer than 30
cm (12 inches) to any part of the Quantum Fluid
Warming System, including cables specied by
the manufacturer. Otherwise, degradation of the
performance of the equipment could result.
PRECAUTIONS:
• Examine all system components for damage, wear,
and functionality prior to use. If any component
appears faulty, damaged or defective, DO NOT USE.
• Inspect all casings, components and
enclosures for damage, cracks, breaks, or
loss of integrity. If any of these are observed,
do not use and replace component.
• Exceeding recommended ow rates and/
or low ambient temperature may result
in lower output temperature.
• Some drugs or drug preparations may be sensitive
to warming. As with any uid or blood warming
system, carefully review the drug manufacturers’
literature for information about thermal sensitivity.
• Do not position the device in a manner that
makes it dicult to view or disconnect the
Controller and/or change the Battery.
• When the useful life of the lithium Battery
has been reached, it should be disposed of
separately in accordance with national and
local codes. Contact your local environment
control or disposal agency for further details.
• Used, single-use components (TIS, TTS-B)
should be disposed of in accordance with
local, national and/or international biohazard
protocols by the appropriate personnel.
• The Controller and Battery are not
intended for patient contact.
• Although the Quantum has been tested to
insure it will survive a drop of 1 meter (3.28 ft),
care should be taken that the system is not
dropped to reduce the potential of damage.
• It is recommended proper Battery and
Controller performance be veried
before each use of the Quantum.
• Fully charge new batteries upon receipt and
prior to use or storage to extend battery life.
• Check Battery charge status prior to each use to
ensure adequate charge for device operation.
• It is recommended that the Battery be fully
charged before initiating warming.
• It is recommended that the Battery
be charged after each use.
• The Battery Charger must be connected
to an earthed mains socket outlet.
• The Controller Jacket should be replaced after every
10 uses (approximate) or six months (whichever
occurs rst) or at anytime the Controller Jacket
appears damaged, loose-tting, or compromised.

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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
Cross Section
Heating element
Binding layer securing
the heating element
Inner tubing (conducts
sterile uid path and
absorbs heat)

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QUANTUM SYSTEM COMPONENTS:
The Quantum Blood & Fluid Warming System consists of sterile thermal
IV tubing (TTS-B or TIS), a Controller (including Jacket), Battery, and Battery Charger..
TUBING SETS:
Thermal Transfusion Set -Blood (TTS-B) |Thermal Infusion Set (TIS)
Intravascular administration sets for infusion (TIS) of IV uids and transfusion (TTS-B) of blood/blood products and IV
uids. The sets are assembled and consist of Life Warmer’s proprietary thermoplastic tubing with integrated copper-
nickel heating elements, temperature sensing thermistors, and standard IV administration components (see Figures 2
and 3). The TIS and TTS-B connect to the Controller via the circuit cartridge connector. The TIS and TTS-B are provided
sterile, for single-patient use only.
Cleaning Kit:
Kit contains hydrophobic coating pack, extra Controller Jacket, and cleaning brush for Jacket connector slot.
Controller:
The Controller is the command center of the Quantum System. It contains the microprocessor
and control algorithm that continually assesses temperature input from tubing thermistors and
regulates the energy provided to the tubing heating elements in the proximal and/or distal
segments to reach and maintain temperature between 38ºC ± 2ºC / 100.4ºF ± 2) at patient
delivery. The Controller receives power when connected to the Battery. The Controller is
reusable. Surface clean/disinfect only. (Controller does not support/require sterilization)..
Controller Jacket:
The Controller comes tted with a Jacket that permits the mating (connection) of the TIS or
TTS-B tubing circuit connector to the connector slot on the Controller. The Jacket must remain
in place for device operation. The Jacket also protects the Controller and should be replaced
after approximately 10 uses or 6 months.
Battery:
Supplies power to the Controller. Battery is lithium-
polymer and rechargeable. Surface clean/disinfect only.
(Battery does not support/require sterilization).
Charger:
For charging the Quantum Battery. AC-powered reusable
component. Surface clean/disinfect only. (Charger does
not support/require sterilization).
Figure 2:
TTS-B Thermal
Transfusion Set -
BLOOD
RED Roller
Clamps
RED Downstream
Roller Clamp
BLUE Roller Clamp
“Y” type
dual spikes
Male Luer
Connector
Male Luer
Connector
Controller
in jacket
Battery Charger
Battery
Injection
Ports
Injection
Ports
& Slide clamps
Slide
Clamps
200 micron ltered
drip chamber
Circuit cartridge
connector
Circuit
cartridge
connector
Drip
chamber
20 gtt/ml
Figure 3: TIS
Thermal Infusion
Set - IV FLUIDS

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THERMAL INFUSION SET (TIS) –
For Infusion of IV Solutions
• Standard spike with vent
• 15 micron particle lter
• Luer activated injection sites
• Male Luer lock adapter
• Tubing length: 80” (230cm) long
• Priming volume: 16 mL
TIS USE: (Use Aseptic Technique):
1. Open pouch where indicated. Remove tubing set
and close roller clamp. DO NOT place tubing, or
protective end caps in sterile eld.
2. Remove Spike protector end cap. Insert spike into
the uid container. Note: keep vent cap closed
unless infusing from a rigid solution container.
3. Fill the drip chamber by squeezing the drip
chamber until approximately half full.
4. Remove protector end cap from male Luer adapter.
5. Slowly open roller clamp to prime tubing and purge
air. Invert and tap injection ports while priming. Once
primed, close roller clamp.
6. Attach adapter to vascular access device. Twist to secure
Luer lock connection.
7. Slowly open roller clamp and adjust for desired ow rate.
Luer Activated Injection Site:
Use only standard Luer connection devices. DO NOT USE needles or blunt cannulas to access the swabable valves.
Using a sterile alcohol pad, swab the Luer activated surface and let it air dry. Carefully connect the syringe or Luer
connector STRAIGHT into the valve in a clockwise twisting motion. To disconnect, twist counter clockwise. Flush the
Luer activated site after each use per facility protocol.
To Initiate Fluid Warming:
1. Completely prime the system following the steps above, purging all air
from the line, and start infusion at desired ow rate. (Note: 7 mL/minute
minimum ow rate is needed to initiate warming. Once warming begins
(Flashing Blue LED), User may titrate to lower ow rates if desired.
2. Briey press the ‘Status’ button on the Battery to check battery
charge. Three green LEDs indicate a full charge. One LED or
no LEDs indicate insucient charge to operate the device. If
the Battery has sucient charge, remove the protective cover
and connect the Controller to the Battery. A green blinking
Controller LED indicates system is ready for use. (Image 1)
3. Connect the Controller to the circuit cartridge
of the TIS by removing its red protective cap
exposing the circuit cartridge. (Image 2)
4. Connect the Controller to the tubing by rmly
pressing the tubing’s circuit cartridge into the
connector slot on the Controller (Image 3). A
Blue ashing LED indicates the uid is warming
but is <36ºC. A solid green LED indicates uid is
≥36ºC and < 44ºC. At steady state, the System
strives to maintain infusion at a set point of
38ºC +/- 2ºC. (Image 4) Note: the System will
attain set point only during owing infusion.
5. Depending on uid temperature and ow rate, the
User may need to adjust the infusion rate to stay in the set point range.
6. When infusion is complete, disconnect the Controller
from the TIS and battery to conserve power.
QUANTUM OPERATION:
To begin using the Quantum Blood & Fluid Warming System, select the
appropriate tubing set for infusion of IV solutions (TIS) or transfusion of blood/blood products or IV solutions (TTS-B).
Follow the directions on page 9 for either the TIS or TTS-B tubing selected.
WARNING:
TIS IS NOT for standalone use with blood products.
Only uid path and area under protective end caps are STERILE.
Status Button
Image 1
Circuit cartridge
Image 2
Image 3
Image 4

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LIFEWARMER
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THERMAL TRANFUSION SET (TTS-B) –
for Blood/Blood Products and IV Solutions
• Dual spike/one vent
• 200 micron lter
• Luer activated injection sites (2)
• Male Luer lock adapter
• Tubing length: 80” (230cm) long
• Priming volume: 22 mL
WARNING: Only uid path and area under protective end caps are STERILE.
TTS-B USE: (Use Aseptic Technique)
Luer Activated Injection Site:
Use only standard Luer connection devices. DO NOT USE needles or blunt cannulas to access the swabable valves.
Using a sterile alcohol pad, swab the Luer activated surface and let it air dry. Carefully connect the syringe or Luer
connector STRAIGHT into the valve in a clockwise twisting motion. To disconnect, twist counter clockwise. Flush the
Luer activated site after each use per facility protocol.
To Initiate Fluid Warming:
1. Open pouch where indicated. Remove the
tubing set and close all three roller clamps.
IMPORTANT: Only uid path is sterile.
DO NOT place tubing, or protective end caps in
sterile eld.
2. Remove Spike protector end cap. Insert one
spike into the uid container, open roller clamp
under uid container. Note: keep vent cap
closed unless infusing from a rigid container.
3. Invertlterchamber.Partially open roller
clamp downstream of lter chamber. Allow
approximately ½ of chamber to ll with uid.
Close downstream (regulating) roller clamp.
4. Partially open roller clamp on unused lead, prime and
close this roller clamp.
5. Return lter chamber to upright position and tap to
displace air trapped in lter. Slowly open downstream
roller clamp to prime, purge air and ll tubing. Invert and
tap injection ports while uid is owing. Ensure air is
expelled, repeat prime if necessary.
6. Attach adapter to vascular access device, twist to secure
Luer lock connection.
7. Slowly open roller clamp and adjust for desired ow rate.
To administer blood, attach blood container to unused
lead. Close roller clamp under solution container. Open
roller clamp under blood container..
1. Completely prime the system following the steps above, purging all air
from the line, and start infusion at desired ow rate. (Note: 7 mL/minute
minimum ow rate is needed to initiate warming. Once warming begins
(Flashing Blue LED), user may titrate to lower ow rates if desired.
2. Briey press the ‘Status’ button on the Battery to check battery charge.
Three green LEDs indicate a full charge. One LED or no LEDs indicate
insucient charge to operate the device. If the Battery has sucient
charge, remove the protective cover and connect the Controller to the
Battery. A green blinking controller LED indicates system is ready for use.
(Image 1).
3. Connect the Controller to the circuit cartridge of the
TTS-B by removing its red protective cap exposing the
circuit cartridge. (Image 2).
4. Connect the Controller to the tubing by rmly pressing
the tubing’s circuit cartridge into the connector slot on
the Controller (Image 3). A Blue ashing LED indicates
the uid is warming but is < 36ºC. A solid green LED
indicates uid is between ≥36ºC and < 44ºC. At steady
state, system strives to maintain infusion at a set point
of 38ºC +/- 2ºC. (Image 4) Note: the System will attain
set point only during owing infusion.
5. Depending on uid temperature and ow rate, the
User may need to adjust infusion rate to stay in the
temperature set point range.
6. When infusion is complete, disconnect the Controller from TTS-B.
Status Button
Image 1
Circuit cartridge
Image 2
Image 3
Image 4

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CHARGING/CONNECTING THE BATTERY
STEP1: Charging the Battery
• Plug the Charger into an AC wall outlet using the AC power cord provided.
The Charger is powered from 100 to 264 Vac, 50/60 Hz
• Connect the Battery to the Charger as shown.
• A solid green LED on the Charger indicates ready for use. A ashing blue
LED on the Charger indicates battery charging failure and the battery
should be removed/replaced.
• Charge status progression is displayed by green LEDs on the battery. This
may be delayed when battery is warm and will initiate automatically once
the battery temp is safe to charge. When fully charged, the battery enters
sleep mode and the LEDs turn o.
• Allow the Battery to charge for 90 minutes (if fully discharged).
STEP2:Checking Battery Charge Status
Verify the charge status of the Battery by briey pressing the Status
button and observing the LED indicators:
• 1 LED illuminated: Battery charge is “Low”. Battery has insucient
charge to operate the device. Charge or replace the Battery.
• 2 LEDs Illuminated: Battery is approximately 50% charged.
• All 3 LEDs illuminated: Battery is fully charged. Allow the Battery
to charge for 90 minutes (if fully discharged).
Note: Battery charge status should be checked prior to each use.
STEP3:Connecting the Battery to the Controller (if preparing to warm uids)
• Remove the protective cover from the Battery.
• Connect the Controller to the Battery by inserting the barrel connector end.
• Upon connection, all three (3) Battery RED LEDs will blink simultaneously with or without an audible tone
(depending on whether the Audible Alert System is enabled) while the Controller initiates its start-up sequence
(i.e., LED ash sequence: blue, yellow, green).
• A green, blinking LED indicates the controller is ready for use
• The Controller (with connected Battery) is now ready for connection to the TIS or TTS-B
Important Battery Use Information:
• The Battery should be FULLY charged on receipt and prior to each use.
• Recharge the Battery after each use – even if not fully discharged.
• Replace the Battery if no green LEDs are illuminated on status check.
• Connect to charger to troubleshoot.
• A fully charged Battery should provide sucient power to warm two (2)
units of refrigerated blood products or approximately 1.0 L of intravenous
solution or at a ow rate of 100 mL/minute (based on a uid input
temperature of 4ºC (38ºF).
• The waterproof vent on the bottom of the Battery is important to maintaining protection from moisture and
Vent
particles. Before use, ensure the vent is intact. If the vent is worn, frayed, or not securely attached,
obtain a new Battery).

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CONNECTING THE CONTROLLER
Connecting the Controller to the TIS or TTS-B tubing
STEP1: Remove the red protective cap from
the middle connector of the tubing set to expose
the circuit cartridge. Discard the red protective cap.
STEP2: Firmly press the circuit cartridge on
the tubing into the connector slot on the black
Controller Jacket as shown in the photo..
STEP3:
Refer to Controller LED illumination for System status.
A ashing Blue LED that increases in intensity and
speed indicates the uid is warming but is <36ºC.
A solid green LED indicates the uid is between ≥36ºC
and < 44ºC.
One green LED ash every second (while connected
to tubing) indicates stand by mode, no ow or uid
ow is too slow to warm.
A solid yellow LED indicates a low battery condition.
A yellow strobe LED indicates a dry line, poor
connection, disconnection or tubing mechanical
failure.
Disconnecting Components /Discontinuing Use
• When infusion is complete, disconnect the Controller from the tubing.
• Disconnect the Controller from the Battery.
• Dispose of contaminated biohazard materials according to CDC and institutional Guidelines.
• Surface clean/disinfect Controller, Battery, and Charger.
• Connect Battery to Charger and allow to charge for 90 minutes for a fully depleted battery.
Circuit cartridge
Step 1
Step 2

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LIFEWARMER
™
ENABLING/DISABLING AUDIBLE ALERT SYSTEM
The Quantum Blood & Fluid Warming System is equipped with a visual and Audible Alert system in the event of an
over-temperature condition. An over-temperature condition can result in hemolysis to blood and/or elevated touch
temperature of the intravascular tubing. Quantum Systems are provided with this feature fully enabled.
However, the Audible Alert System may pose a hazard to certain military and/or tactical medical users depending
on the use environment. For these users and use cases only, if the presence of the audible alert presents a
potential hazard, it may be disabled by following the instructions below.
Disabling Audible Alert System
1. Press and hold the Status button on the Battery
continuously for 15 seconds until hearing 3 beeps and
seeing three ashes of the Red LEDs.
2. The Audible Alert System is now deactivated.
The audible alert self check tone on component
connection and in the event of an over-temperature
condition is now silenced until user re-enables. (Note:
the visual over-temperature alert (Red LED strobe)
remains active.
Re-enabling/Self Check
of the Audible Alert System
1. Press and hold the Status button continuously for 15 seconds until hearing the audible alert beep 1 time and the 3
LEDs blink once.
2. The Audible Alert System is now reactivated.
3. The audible self-check tone will now be active when the controller is connected to the battery.
It is strongly recommended that the (over-temperature) Audible Alert System remain enabled unless a tactical hazard
is posed. Re-enable the Audible Alert System following the steps above as soon as possible after the tactical hazard is
no longer present.

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LIFEWARMER
™
STERILITY STATUS
Sterile Components
Only the uid path and area under the protective end caps of the TIS and TTS-B tubing sets are STERILE. Sterilization
is achieved by exposure to Ethylene Oxide (EO). Note: the protective end caps on the tubing sets should ONLY be
removed immediately prior to tubing use. DO NOT place tube sets or protective end caps in the sterile eld.
Product must be stored in the original unopened packaging where temperatures are between -20ºC to 60ºC. Verify the
‘Use By’ date on the packaging. If it is past the ‘Use By’ date, DO NOT USE.
Single [Patient] Use Components
The Quantum TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set – Blood) are disposable, for Single Patient
Use Only. Do not reprocess or resterilize.
Non-Sterile/Reusable Components
The Controller with Jacket, Battery and Charger are reusable and are provided non-sterile. These components do
not support sterilization, but instead should be surface cleaned/disinfected after each patient use according to the
instructions contained in this manual.
CLEANING AND DISINFECTING
Cleaning and Disinfecting Instructions
The Quantum Controller with Jacket, Battery, and Charger are supplied non-sterile and should be surface cleaned/
disinfected after each patient use.
Before cleaning, disconnect the Controller from the Battery. Remove the Battery from the Charger and/or unplug the
Charger from AC power. (Failure to do so before initiating cleaning may expose personnel to unsafe conditions and
result in damage to the device). Note: the following procedures are not guaranteed to control the spread of pathogens.
Consult the local hospital infection control administrator regarding cleaning procedure policies at your institution..
Cleaning
After each use, clean all exterior surfaces of the Controller (with Jacket in place), Battery, and Charger, with a soft
cloth moistened with a mild detergent solution. Remove any residual cleaner from the component surfaces. Dry all
component surfaces. As Needed: the Controller Jacket Connector Slot may be cleaned using the brush provided in
the Cleaning Kit.
Disinfecting
After each use, disinfect all exterior surfaces of the reusable components, i.e., Controller with Jacket, Battery, and
Charger, with a low-level disinfectant (sucient for normal use conditions) with one of the following: 70-90% Ethyl or
Isopropyl Alcohol, Sodium Hypochlorite (5.25-6.15% household bleach diluted 1:500). or commercial medical-grade
wipe (e.g., Kim-Wipe). Dry all component surfaces.
Controller Cleaning/Jacket Replacement
After the Controller is used approximately 10 times (or six months), remove the Jacket and clean the entire Controller,
including the inside of the Circuit Cartridge, with 70-90% Ethyl or Isopropyl Alcohol. Let dry 2 minutes. Using Quantum
Cleaning Kit, reapply Hydrophobic Coating to the Circuit Cartridge and install a new Jacket. Note: Once a Jacket has
been removed, it should be discarded and replaced with a new Jacket.
When using in conditions of excessive moisture (e.g., eld use/rain, etc.), reapply hydrophobic coating and replace the
Jacket after each use. (Note: do not reuse Jackets. If the Jacket is removed, it must be replaced with a new Jacket to
ensure proper t).
Note: Do not use caustic or abrasive cleaners or strong solvents.

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LIFEWARMER
™
VISUAL/AUDIO INDICATORS
The Life Warmer Quantum Blood & Fluid Warming System is designed for simple, reliable operation.
Refer to the Visual/Audio Indicators Legend presented below.
Quantum Controller NORMAL Conditions
LED INDICATOR MEANING(S) ACTION REQUIRED
Start-Up Sequence
Controller initializing
sequence No action required.

Blue
Flash

Yellow
Flash

Green
Flash
Clear
Flash
Green Flash - every 4 seconds
when NOT Connected to Tubing
Self-Check OK
Ready for Use Connect Controller to primed tubing set
Green Flash - every second
when Connected to Tubing
Controller connected to
tubing and ready for ow.
(Standby Mode).
No ow or
ow too slow to warm
Increase ow rate if warming is desired.
If no further warming desired, disconnect system
Blue Flashing RAMP UP
(Flashing LED with increasing
intensity/speed)
Fluid is warming and/or
temperature (<36ºC)
Flow rate may be exceeding heating capacity.
Consider reducing ow rate if clinically acceptable.
Check tubing for possible contact
with cold surface outdoors.

Green Solid Fluid is warmed to
≥36ºC (in steady state).
No action required
Refer to Quantum System Response
by Temperature Table in Appendix.

Yellow Solid Low battery condition Charge or replace Battery Pack
Quantum Controller ALERT Conditions
LED INDICATOR MEANING(S) ACTION REQUIRED
Yellow – Flashing
(3 ashes – 1 every half
second)
Dry line
Poor connection
Intentional disconnection*
Tube mechanical failure.
*Reminder to reattach to
tubing set if further
warming is desired.
Disconnect Controller from tubing set, ensure tubing
set is completely primed and no air in line.
If properly primed, reattach the Controller to the
tubing set and the yellow strobe should stop.
If yellow strobe persists, tubing set may have a
mechanical failure. Disconnect Controller and tubing
from patient. Obtain a new Quantum Tubing Set,
follow Quick Start to prime and attach to patient.
Disconnect Controller from Battery to conserve
battery power if no further warming is desired.
NO LEDS
Poor connection to Battery,
Battery Dead or
Controller failure
Check connection to Battery.
Check charge status of Battery.
If connection is proper and Battery is charged,
replace the Controller.
USER INTERFACE VISUAL/AUDIO LEGEND

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LIFEWARMER
™
Quantum Battery Pack ALERT Conditions
LED INDICATOR MEANING(S) ACTION REQUIRED
Red –STROBE and/or
AUDIBLE ALERT
(Sustained)
FLUID OVER
TEMPERATURE
Stop uid ow. Disconnect Controller
from Battery and from tubing set..
Check infusion solution container and line.
If solution container does not feel warm to the touch,
reapply (reconnect) the Quantum System.
Note: If audible alert is disabled,
then only RED LED will strobe.
Audible Alert
is enabled
The Red Battery LEDs and Audible Alert will activate briey
each time the Controller is connected to the Battery in the
normal condition with a charged battery as a functional test.
If NO LEDs, the Battery may be out of charge or
malfunctioning.
3 Red LEDs ash
simultaneously during
Start-Up and Audible Alert
Quantum Battery Pack NORMAL Conditions
LED INDICATOR MEANING(S) ACTION REQUIRED

Green Solid
(Battery Status)
1 Green LED – Battery
Low (insucient to
operate device)
Charge or replace Battery
 
2 Green LEDs – 50%
charged (approximate)
Sucient to power device, but recommend
charging until fully charged
  
3 Green LEDs –
Fully charged No action required
Quantum Charger Conditions
LED INDICATOR MEANING(S) ACTION REQUIRED

Green Solid Normal Charging
Continue charging until Battery status indicates fully
charged (three LEDs illuminated). A fully depleted Battery
requires 90 minutes to fully charge
Blue - Flashing Battery charging failure
Disconnect Battery from Charger, wait 5 seconds
and reconnect to Charger.
If condition persists, obtain a new Battery.
USER INTERFACE VISUAL/AUDIO LEGEND (continued)
Military and Tactical Medicine users: If the presence of an audible alert presents a hazard, it may be deactivated by
the user. Press and hold the status button continuously for 15 seconds until hearing three quick beeps and seeing
three ashes of the Red LEDs, the audible alert is now disabled. To reactivate, press and hold the status button again
for 15 seconds until one beep occurs and the Red LEDs ash once.
VISUAL/AUDIO INDICATORS

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LIFEWARMER
™
TECHNICAL SPECIFICATIONS
The Quantum Blood & Fluid Warming System has been tested and found to comply with recognized
standards for electrical safety and electromagnetic compatibility. These limits are designed to provide
reasonable protection against harmful interferences in clinical use environments. The System generates
radio frequency energy and should be installed and used in accordance with these instructions.
Essential Performance:
The Essential Performance of the Quantum Blood & Fluid Warming System is to indicate outow uid temperature
when at or outside the pre-set temperature range (≥ 36 to < 44ºC at steady state) to the Operatoand to detect proper
operational status.
Essential performance is conrmed by verifying start-up LED sequences of the Battery and Controller upon connection.
This conrmation should be performed before each use of the System. Upon connection, all three (3) Battery RED LEDs
will blink simultaneously with or without an audible tone (depending on whether the Audible Alert System is enabled)
while the Controller initiates its start-up sequence (i.e., LED ash sequence: blue, yellow, green,clear ).
System Information/Safety Classications:
BF Applied Part – TIS/TTS-B Fluid Path
ME System .........................................................................................................................................Battery, Controller, TIS/TTS-B, Charger
ME Equipment.................................................................................................................................Battery, Controller, TIS/TTS-B
Type of protection against electrical shock ..........................................................Class 1 / internally powered
Degree of protection against electric shock ........................................................Type BF
Mode of Operation ......................................................................................................................Continuous
Performance (Warming):
Fluid Temperature Set Point ...............................................................................................38ºC ± 2ºC (100.4ºF ± 2)
Fluid Warming Volume* ..........................................................................................................Up to 1000 mL of blood products at 4ºC
uid input at a ow rate of 100mL/min
Up to 1700 mL of IV solutions at 20ºC input a
a ow rate of 200 mL/min
Eective Set Point Warming Flow Rate* ..................................................................2 to 100 mL/minute 4ºC uid input
2 to 200 mL/min 20ºC uid input
*Based on fully charged battery and depending upon starting ambient temperature.

-19-
LIFEWARMER
™
Controller
PARAMETER VALUE
Operating Input
Voltage (Vdc) 33.0 (min); 44.4 Typical; 55.0 Max
Input Voltage
Absolute Max (Vdc) 56.0
Operating Current (A) 0.001 minimum / 8.0 Max
Power interruption
tolerance (ms) 30
Charge Voltage (Max) 4.20V +/- 0.03V /cell
Charge Current (Max) 1.6A
Liquid/Solid Ingress Controller with Jacket: IP 53
Weight 2.5 oz
Service (Use) Life 1000 insertions/removals
TIS/TTS-B
PARAMETER VALUE
Sterility – Fluid path/
area underneath
protective end caps
Ethylene Oxide
Biocompatibility ISO 10993
Infusion Set
Compatibility ISO 8536-4
Liquid/Solid Ingress
With protective cap on
card connector
IP 53
Weight: ≤ 60g (TIS)
≤ 75g (TTS-B)
Service (Use) Life (Per) Single Patient Use
Charger
PARAMETER VALUE
AC Power 100 to 264 Vac, 50, 60 Hz
Equipment Class Class I
Type Part B
Charge Voltage (Max) 50.4Vdc +/- 1%
Liquid/Solid Ingress IP 22
ESD
Level 3, 4KV direct
contact;
+/-8KV air discharge
Weight 20 oz
Service (Use) Life 2500
insertions/removals
Battery
PARAMETER VALUE
Conguration 12 S1P / Li-Pol pouch cells (3.7v)
Chemical System Lithium
Nominal Voltage 44.4 V
Capacity Rated: 910mAh
Minimum: 850mAh
Conguration 12S1P
Discharge Current
(Max)
6A continuous
9A peak, 200 Hz 50% duty cycle
Discharge Cuto
Voltage 33.0V (2.75V per cell)
Charge Voltage (Max) 4.20V +/- 0.03V /cell
Charge Current (Max) 1.6A
Energy Rating 40.4 Wh
Liquid/Solid Ingress IP 67
Weight 16 0z
Service (Use) Life 3 years/500 cycles
Shelf-Life Stored batteries with 30%
charge will last 3 months.
Component Specications:
TECHNICAL SPECIFICATIONS

-20-
LIFEWARMER
™
TIS / TTS-B Tubing Sets
PARAMETER OPERATING CONDITIONS SHIPPING/STORAGE CONDITIONS
Temperature -15ºC to +60ºC -20ºC to +60ºC
Humidity 0% to 95% relative humidity, non-condensing 0% to 95% relative humidity, non-condensing
Atmospheric Pressure 62 kPA to 106 kPA 62 kPA to 106 kPA
Warm-up/ Cool-Down
from Storage Extremes 2 minutes 2 minutes
Altitude 12,000 ft 12,000 ft
Controller
PARAMETER OPERATING CONDITIONS SHIPPING/STORAGE CONDITIONS
Temperature -15ºC to +50ºC -20ºC to +60ºC
Humidity 0% to 95% relative humidity, non-condensing 0% to 95% relative humidity, non-condensing
Atmospheric Pressure 62 kPA to 106 kPA 62 kPA to 106 kPA
Warm-up/ Cool-Down
from Storage Extremes 2 minutes 2 minutes
Altitude 12,000 ft 12,000 ft
Battery
PARAMETER OPERATING CONDITIONS SHIPPING/STORAGE CONDITIONS
Temperature 0ºC to +45ºC (charging)
-20 to +50ºC (discharging) -20ºC to +60ºC
Humidity 0% to 95% relative humidity, non-condensing 0% to 95% relative humidity, non-condensing
Atmospheric Pressure 62 kPA to 106 kPA 62 kPA to 106 kPA
Warm-up/ Cool-Down
from Storage Extremes 2 minutes 2 minutes
Altitude 12,000 ft 12,000 ft
Charger
PARAMETER OPERATING CONDITIONS SHIPPING/STORAGE CONDITIONS
Temperature -20ºC to +45ºC -20ºC to +60ºC
Humidity 0% to 95% relative humidity, non-condensing 0% to 95% relative humidity, non-condensing
Atmospheric Pressure 62 kPA to 106 kPA 62 kPA to 106 kPA
Warm-up/ Cool-Down
from Storage Extremes 2 minutes 2 minutes
Altitude 12,000 ft 12,000 ft
OPERATING, STORAGE and
DISTRIBUTION CONDITIONS