Quality QIF-01-12 User manual

QIF-IFU-00001 Rev. A6
December 2022
Warrior Extreme
Blood and Fluid Warmer
Model QIF-01-12
Instruction for Use (IFU)

QIF-IFU-00001 Rev. A6
Page 2 of 28
PROPRIETARY AND CONFIDENTIAL
Copyright © 2022 by Quality in Flow (QinFlow) Ltd.
All rights reserved. No part of this manual may be reproduced or copied in any form by any means-
graphic, electronic, or mechanical, including photocopying, typing or information retrieval systems-
without written permission of Quality in Flow Ltd.
Quality in Flow (QinFlow) Ltd. 23 Ha-Yetsira St. Petah Tikva Israel 4951251
MedNet EC-REP GmbH Borkstrasse 10, 48163 Münster, Germany
0482

Table of Contents
QIF-IFU-00001 Rev. A6
Page 3 of 28
TABLE OF CONTENTS
1. Indications for Use _________________________________________________________ 4
2. Intended Use ______________________________________________________________ 4
3. Package Contents __________________________________________________________ 4
4. System Description_________________________________________________________ 5
5. System Components________________________________________________________ 6
Base Unit _________________________________________________________________________________ 6
Compact Disposable Unit_____________________________________________________________________ 6
Intended Users _____________________________________________________________________________ 7
Fluid Warming Capacity _____________________________________________________________________ 7
6. Preparing and Operating the System __________________________________________ 8
Charging the Battery ________________________________________________________________________ 8
Preparing the System for Warming _____________________________________________________________ 9
Connecting the Base Unit to the Compact Disposable Unit___________________________________________ 9
Connecting the Warrior Extreme to the Fluid Bag and Patient _______________________________________ 11
Warming Blood or Intravenous Fluid Products ___________________________________________________ 13
General Operation Instructions________________________________________________________________ 14
Self-Test _________________________________________________________________________________ 14
Stopping the Warrior Extreme device Fluid / Blood Warming _______________________________________ 14
Battery Replacement during Administration _____________________________________________________ 15
7. System Notifications and Troubleshooting ____________________________________ 17
8. Specifications and Characteristics ___________________________________________ 19
Electrical Specifications _____________________________________________________________________ 19
Physical Properties _________________________________________________________________________ 19
Environmental Conditions ___________________________________________________________________ 20
Electromagnetic Compatibility (EMC) Conditions ________________________________________________ 20
9. Cleaning the System_______________________________________________________ 24
Cleaning the Compact Disposable Unit _________________________________________________________ 24
Cleaning the Base Unit and Battery ____________________________________________________________ 24
10. System Precautions _______________________________________________________ 25
11. Warnings __________________________________________________________ 26
12. Disclaimer and Warranty __________________________________________________ 27
Disclaimer _______________________________________________________________________________ 27
Warranty_________________________________________________________________________________ 27
13. Symbols and Legends______________________________________________________ 28

Do not use the Warrior Extreme system before viewing training materials and
carefully reading the following instruction for use!
1. Indications for Use
QinFlow (QiF)Blood and Fluid Warmer device (the “Warrior Extreme”) is intended
for warming blood, blood products, and intravenous fluids prior to administration.
It is intended to be used by healthcare professionals in hospital, clinics and field
environments, to help prevent hypothermia.
2. Intended Use
Whenever parenteral introduction of normothermic fluid is required or indicated.
3. Package Contents
The Warrior Extreme package includes the following items:
Figure 1. Package contents
a. One Base Unit (BU) (item a).
b. One Rechargeable Battery (item b).
c. One Battery Charger – model Fuyuang FY2552000 (item c).
d. One Charger adapter (item d).
e. Quick user guide
*The Warrior Extreme is provided in a hand carry bag. The bag can contain one
additional battery, and its top compartment can be used for carrying up to 4 Compact
Disposable Unit.

Warrior Extreme Blood and Fluid Warmer Instructions for Use
System Description
QIF-IFU-00001 Rev. A6
Page 5 of 28
4. System Description
What is the Warrior Extreme Blood and Fluid Warmer?
The Warrior Extreme Blood and Fluid Warmer is an inline, battery-powered,
lightweight and completely portable system, for warming blood, blood product and IV
fluids. The Warrior Extreme can be used to help prevent hypothermia
The system is positioned out of the patient's body, between the IV tubing and the patient,
with a temperature set point of 38 °C ± 2 °C (100.4 °F ± 3.6 °F). The Warrior Extreme
provides both audio and visual notifications.
Figure 2. Warrior Extreme Blood and Fluid Warmer (illustrated set-up)
Fluid bag
Warrior Extreme
Base Unit
Compact
Disposable unit
IV set
Outflow tube from
Disposable Unit with
heated fluid to the
patient
Inflow from IV
bag to QIF
Disposable Unit
Base Unit to
Disposable
Unit
connecting
Cable

Warrior Extreme Blood and Fluid Warmer Instructions for Use
System Components
QIF-IFU-00001 Rev. A6
Page 6 of 28
5. System Components
The Warrior Extreme includes a reusable Base Unit and a sterile, single patient use
disposable cartridge, called the Compact Disposable Unit (CDU).
Base Unit
The Base Unit comprises an LCD, On/Off switch, green pushbutton, and a detachable
rechargeable battery. It also includes a connecting cable that when not in use, is wrapped
around its back side.
The battery is inserted from the bottom of the Base Unit.
The LCD, located on the front of the Base Unit, displays the fluid outflow and inflow
temperature, the battery charging level and additional notifications described later on.
The On/Off button is on the Base Unit rear side and the green Mute/”Self-Test” button is
on the Base Unit front side.
Figure 3. Base Unit front and rear views
Compact Disposable Unit
The Compact Disposable Unit is a sterile, single patient use disposable cartridge which
includes a heat exchanger. At the bottom of the Compact Disposable Unit are inlet and
outlet fluid flow Luer connectors.
The Fluid Bag is connected with a standard IV / blood administration set to the Compact
Disposable Unit Inlet Luer. The Outlet Luer of the Compact Disposable Unit is
connected to a standard Venflon.
A connecting cable connects between the Base Unit and the Compact Disposable Unit.
1. LCD
2. Self-Test/Mute
button
3. Connecting
Cable
4. Rechargeable
Battery
5. On/Off Switch
1
2
4
3
Front view Rear view
2
1
3
4
5

Warrior Extreme Blood and Fluid Warmer Instructions for Use
System Components
QIF-IFU-00001 Rev. A6
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Figure 4. Compact Disposable Unit
Intended Users
Who should use the Warrior Extreme Blood and Fluid Warmer?
The Warrior Extreme should only be used by qualified healthcare professionals that have
read the training materials and this IFU, and fully understand how to operate this system.
Fluid Warming Capacity
How much fluid can the Warrior Extreme warm using a fully charged battery?
The amount of fluid the Warrior Extreme can warm depends on the battery charge level,
inlet fluid temperature and flow rate.
When using a fully charged battery, at flow rate of 160–180 ml/min, the Warrior Extreme
can warm up to three liters of parenterally administrated fluid with an inlet temperature
of 4 °C (39.2 °F).
When there are extreme changes in the flow rate or the inlet fluid temperature, the
Warrior Extreme will require an adjustment period of up to 20 seconds. A set of internal
2
1
3
3
2
1
1
Inlet Luer
2
Outlet Luer
3
Connector to Base Unit or Extension Cable
Connecting
Cable
Out
In
Base Unit
Figure 5. Base Unit connected to the
Compact
Disposable Unit

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
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sensors constantly measure the fluid temperature and adjust the power supplied to the
heat exchanger accordingly.
6. Preparing and Operating the System
Charging the Battery
The Warrior Extreme is powered by a researchable battery, which should be fully
charged before use. The battery shall be charged using the supplied Battery Charger
model FUYUANG FY2552000. Charging requires 120/240 [V], 50/60 Hz.
Plug the Battery into the Battery Charger using the charger
adapter, and plug the Battery Charger into an AC electrical
outlet.
Note: the battery shall be charged using only its
designated charging adapter.
Note: the battery charger adapter shall be attached to
the battery in the correct orientation: the charger
adapter label in on the opposite side of the battery
label, as shown in the picture on the right
Allow the battery to charge until the battery is fully
charged. When the battery is fully charged, the battery
charger green LED lights.
(This is expected to be approximately 4—5 hours if the
battery is empty).
When the battery is fully charged, disconnect the battery
from the battery charger adapter and place the battery
inside the Base Unit or store it for later use.
Note: The battery has a correct insertion orientation.
Before inserting, make sure the battery label is
alongside the Base Unit label. If the battery is
inserted in the wrong orientation, the battery will
not dock into the Base Unit.
Important! Recharge the Battery after each use and ensure it is full before each use
Store only fully charged batteries.
When placed in long storage, charge the batteries every 4-6 months.
WARNING: Never throw the Warrior Extreme battery into the trash. The battery should
be disposed of at a designated battery disposable collection point.

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
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Preparing the System for Warming
WARNING: Follow all the instructions provided by the manufacturer of the
blood/intravenous fluid administration set when administrating blood or fluid through the
Warrior Extreme.
The Compact Disposable Unit cartridge is provided sterile
in a sterile bag. Visually inspect the Compact Disposable
Unit package before opening to ensure that there is no
damage to the packaging or to the product.
Do not use the Compact Disposable Unit if the sterile
package is damaged or is not fully sealed.
Do not reuse the Compact Disposable Unit. The
Compact Disposable Unit is for a single use only.
YY/MM; Do not use if the date has passed the end of
the indicated expiration month (i.e. 20/03, valid until
31st of March 2020).
Do not re-sterilize the Compact Disposable Unit
Insert the battery into the Base Unit and close the side
latches.
Pay attention to the correct battery insertion orientation:
the battery label should be alongside theBase Unit label. If
you insert the battery in the wrong orientation, the battery
will not dock with the Base Unit. If this happens, remove
the battery, turn it 180 degrees and reinsert into the Base
Unit.
For more instructions on how to replace the battery during
administration, see section 6.9.
Open the Compact Disposable Unit sterile package.
Connecting the Base Unit to the Compact Disposable Unit
Note: When connecting the cable to the Compact
Disposable Unit, verify the protrusion marks on
the connector and on the Compact Disposable

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
Page 10 of 28
Unit are aligned (see arrow marks in the images
on the right)
Connect the Base Unit cable to the Compact Disposable
Unit
Note: the disconnections of the cable shall be
performed by holding and pulling the designated
connector (top image on the right), and NOT by
holding and pulling the cable or holding and
pulling the ferrites on the cable (bottom image on
the right).
Important! Disconnect the cable from the Compact
Disposable Unit only by pulling the designated
connector.

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
Page 11 of 28
Connecting the Warrior Extreme to the Fluid Bag and Patient
The Warrior Extreme is compatible with any standard IV administration set that utilizes
standard Luer connections.
WARNINGS:
•Warming IV fluids/blood at flow rates higher than 200 ml/min (for example by using
a pressure infusion bag or fluid pump) may result in temperature outputs of lower
than 38 ± 2 °C.
•Do not use Warrior Extreme in MRI, X-ray and CT environments!
•Warming medications through the Warrior Extreme was not validated!
•No modification of this equipment is allowed!
•Use of the Warrior Extreme inconsistent with its instructions may result in failure of
the system or injury to patient.
Remove the Inlet Luer cap from the inlet tube of the
Compact Disposable Unit (marked as "IN" on the CDU
casing).
The inlet tube connects to the IV set outlet.
Note: When connecting the IV tubing to the Inlet Luer
do not over tighten! (apply similar force as
applied when connecting the IV tubing to the
venflon).
Connect IV tubing to the Inlet Luer, and tighten until
resistance is met.
Remove the Outlet Luer cap from the outlet end of the IV
extension tube (marked as "OUT" on the CDU casing).
The outlet tube connects to the venflon.

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
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WARNING: Always flush the line with intravenous
fluid / blood / blood product before administrating to
patient.
WARNING: Warming medications through the
Warrior Extreme was not validated.
Note: The Compact Disposable Unit is a single use
item, supplied sterile and ready for use. If
cleaning during use is necessary, wipe the
external surfaces of the Compact Disposable Unit
with a damp cloth with water or alcohol (Iso-
Propanol/Ethanol).
Connect the IV line to the fluid bag and flush the line with
the intravenous fluid/blood.
Priming the
CDU

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
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Warming Blood or Intravenous Fluid Products
WARNING: Always flush the line with intravenous fluid / blood / blood product before
administration to the patient.
Switch on the Base Unit, by moving the On/Off switch on
the back side of the system to “I” position.
The LCD displays the “Initializing…” message and you
will hear a steady beep.
Start flowing IV fluid / blood through the Compact
Disposable Unit. The system will reach the set-point
temperature in a few seconds.
During this time the LCD displays:
Heating
Tout: outflow temp °C (inflow temperature °C); the
temperature is presented in Celsius degrees (°C).
For example: “Tout: 38 °C (8 °C)”.
Verify the system warms the intravenous fluid, blood or
blood product to the set-point temperature; and check the
LCD display from time to time to verify normal system
operation.
Read the notification on the LCD display following each
audio notification (short or steady beep).
From this stage on, follow the fluid or blood
administration instructions provided by the manufacturer
of the IV/blood administration set and your facility
protocols.
Note: You can administer several fluid bags using the
same Compact Disposable Unit. The Warrior
Extreme does not need to be shut off while
replacing the fluid bag.

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
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General Operation Instructions
During infusate administration, the Base Unit can be positioned beside the patient in an
upright position or on its back, ensuring the LCD is visible.
The Compact Disposable Unit can be located beside the patient or hung on a
pole/gurney, in a secured place to avoid a sudden pull.
WARNING: Do not cover the display or the speaker of the Base Unit.
WARNING: Do not use the Warrior Extreme if there is a display and/or a speaker
malfunction.
During administration keep track of the display and sound notifications. For details on
system notifications and troubleshooting, see Chapter 7.
Self-Tes t
To check the Base Unit is properly communicating with the Compact Disposable Unit
(i.e., in case the system is not heating the fluid/blood), use the “Self-Test” feature by
pressing the green pushbutton for 3 seconds.
Figure 5. Self-Test/Mute Button
In “Self-Test” mode the blood or fluid flows through the system but is not warmed.
See additional details in the troubleshooting chapter (Chapter 7).
Stopping the Warrior Extreme device Fluid / Blood Warming
You do not have to replace the Compact Disposable Unit when replacing the fluid or
blood bag. You can administer several fluid bags using the same Compact Disposable
Unit.
You do not have to shut off the Warrior Extreme system when replacing the fluid bag.
When blood / intravenous fluid administration is stopped, verify that the fluid / blood
flow also stopped, and disconnect the Compact Disposable Unit outlet from intravenous
catheter.
Always replace the Compact Disposable Unit when replacing the blood IV
administration set, and repeat stages a—d is section 6.4 above.
Dispose of the Compact Disposable Unit taking biohazard precautions.
Self-Test /Mute
Button

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
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WARNING: Always flush the line with intravenous fluid/blood before administration to
the patient’s body.
Battery Replacement during Administration
The battery status is reported by audio and visual notifications.
Table 1. Battery Indications
Battery Indications Battery Status Required Action
Note: Battery is
getting Low!
The LCD blinks, and
a steady beep is
sound.
25—30% capacity Pay attention, a ''Battery Empty''
message will follow.
Battery Empty 5—10% capacity The device will continue warming
the fluid until the battery is fully
depleted. The system will then shut
down.
During battery replacement there is no need to stop the fluid flow; although unheated
fluid will flow during this time.
To replace the battery and resume fluid heating, follow the instructions below without
delay.
WARNING: While the Base Unit is in the “Off”
position the fluid/blood continues flowing through
the system without being warmed until the system is
turned on, completes initialization and starts warming
again.
Shut off the Warrior Extreme Base Unit by pressing the
On/Off switch on the back of the system to “0” position.

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Preparing and Operating the System
QIF-IFU-00001 Rev. A6
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Remove the empty battery from the Warrior Extreme by
opening the two side latches and pulling out the battery.
Replace the empty battery with a fully charged battery
and close the side latches.
Pay attention to the correct battery insertion orientation:
the battery label should be alongside theBase Unit label.
If you insert the battery in the wrong orientation, the
battery will not dock with the Base Unit. If this happens,
remove the battery, turn it 180 degrees and reinsert into
the Base Unit.
Switch on the Base Unit. The LCD displays the
“Initializing…” message and a steady beep is sound.
Start flowing IV fluid / blood through the Compact
Disposable Unit The system will reach the set-point
temperature in a few seconds.
During this time the LCD displays:
Heating
Tout: outflow temp °C (inflow temperature °C); the
temperature is presented in Celsius degrees (°C).
For example: “Tout: 38 °C (8 °C)”.
Follow the fluid or blood administration instructions
provided by the manufacturer of the IV/blood
administration set and your facility protocols.

Warrior Extreme Blood and Fluid Warmer Instructions for Use
System Notifications and Troubleshooting
QIF-IFU-00001 Rev. A6
Page 17 of 28
7. System Notifications and Troubleshooting
The following table provides descriptions of possible issues that may occur while
operating the system including the visual and audible notifications, and suggested actions
for fixing the problem.
Table 2. System Notifications and Troubleshooting
Description LCD Notification Audio
Notification User Action (if required)
System Initializing QiF-01 (VX.X) Is
Initializing Steady beep Monitor the LCD
System waiting for
Compact Disposable
Unit connection
System is Ready
Connect the DU No
Connect the Base Unit to the
Compact Disposable Unit with the
Connecting Cable.
Normal Operation
Heating
Tout: XX °C (YY °C)
XX °C is the outflow
temperature; YY °C is
the inflow temperature
No Keep monitoring the LCD display
Fluid flow
irregularities Change in Flow No
•Open the IV set roller clamp until
the required flow is reached.
•Look for IV kink and release it.
•Replace the IV tubing if necessary.
No display on LCD,
though the system is
turned on
No display No
Check the On/Off switch is turned on.
If it is, replace the battery.
If after replacing the battery the
display is still not working, do not use
this Warrior Extreme until repaired by
the manufacturer or by its
representative.
Fuel gauge Battery bar No Monitor and pay attention to the
battery status
Battery energy status
is at 25-30% capacity
Note: Battery is Getting
Low!
The LCD blinks Steady beep
Pay attention, a ''Battery Empty''
message will follow.
You can Mute the audio notification
with a short press on the Self-
Test/Mute button.
Battery is critically
low
Battery Empty
Tout: XX °C (YY °C) Steady beep
Replace the empty battery with a fully
charged, battery (see section 6.9 for
instructions).
You can Mute the audio notification
with a short press on the Self-
Test/Mute button.

Warrior Extreme Blood and Fluid Warmer Instructions for Use
QIF-IFU-00001 Rev. A6
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Description LCD Notification Audio
Notification User Action (if required)
Fluid is warmer than
41 °C
Fluid is hot!
Tout: XX °C (YY °C)
The LCD blinks
No
''Fluid is Hot'' message might appear
due to flow irregularities (e.g. block,
back flow, large bubbles) or sudden
and significant changes in flow rate
(e.g. changing from 180 ml/min to 40
ml/min).
If none of the above conditions is
apparent, turn off the Base Unit and
replace the Compact Disposable Unit
with a new one.
You can mute the audio notification
with a short press on the Self-
Test/Mute button.
Fluid is warmer than
42 °C
Fluid is hot!!!
Tout: XX °C (YY °C)
The LCD blinks
Steady beep
Fluid outflow
temperature decreased
to 35 °C (95 °F) or
colder, even though it
reached a temperature
above 35 °C (95 °F)
before.
T out indication is 35
°C (95 °F) or below Short beep
Check if fluid input temperature is at
least 4 °C (39.2 °F) and check the
battery status.
Keep track of the LCD display.
System malfunction
(HW/SW) System Error Steady beep Make Sure that the Compact
Disposable Unit is flushed and filled
with fluid and restart the system by
shutting it off and then on again.
If the problem is not resolved shut off
the system, replace the Compact
Disposable Unit with a new one, flush
the air out of the Compact Disposable
Unit, and turn the system back on.
If the problem is not resolved contact
the manufacturer or its representative.
General malfunction
*MALFUNCTION!!*
Tout: XX °C (YY °C)
The LCD blinks
Steady beep

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Specifications and Characteristics
QIF-IFU-00001 Rev. A6
Page 19 of 28
8. Specifications and Characteristics
Note: Operation out of the design specifications may result in a lower outflow temperature
and/or damage to the system.
Electrical Specifications
Table 3. Electrical Specifications
Parameter Value
Nominal Input Voltage 22 VDC from a fully charged battery
Max Current 26 A
Battery life expectancy Up to 400 charging cycles
FUYUANG Charger FY2552000 100–220 VAC
50–60 Hz Max 0.9 A
Defibrillation Proof type CF Applied Part The Compact Disposable Unit is
safe to be used when joined with
a defibrillator
and direct cardiac application
Physical Properties
Table 4. Physical Properties
Parameter Value
Weight of Base Unit with battery Approximately 1720 g (3.79 lb)
Weight of Compact Disposable Unit in
sterile bag
Approximately 117 g (0.26 lb)
Dimensions of Base Unit with battery
H × W × L
Approximately 232×156×78 mm
(9.13×6.14×3.07 in)
Dimensions of Compact Disposable Unit
H × W × L
Approximately 72.2x68.5x117.5 mm
(2.84x2.70x4.63 in)

Warrior Extreme Blood and Fluid Warmer Instructions for Use
Specifications and Characteristics
QIF-IFU-00001 Rev. A6
Page 20 of 28
Environmental Conditions
Table 5. Environmental Conditions
Parameter Value
Storage & Transport conditions -20 °C to 60 °C & 93% RH
(-4 °F to 140 °F & 93% RH)
Transient conditions 20 °C to + 50 °C & 15% to 90% RH
Storage conditions** -30oC to 70oC (-22oF to 158oF)
Operation Temperature & Humidity 5 °C &15% RH to 40 °C & 93% RH
(41 °F &15% RH to 104 °F & 93% RH)
Operating Temperature** -5°C to 40oC (23oF to 104oF)
Atmospheric Pressure/(Altitude)*** 549 to 1,060 hPa
(-400 to 4,572 meters); (-1312 to 15,000 ft)
Compact Disposable Unit Shelf Life 3 years
Base Unit Service Life* 5 years
Water and particles Ingress rate**** IP56
* The Base Unit does not require any calibration or maintenance. At the end of the service
life period turn to the manufacturer for Base Unit refurbishing options.
** In Compliance with EN1789:2007 +A2:2014
*** In compliance with IEC60601-1-11:2010 section 4.2.2c
**** Water and particles Ingress rate (IP rating) of the system is the Base Unit IP
Electromagnetic Compatibility (EMC) Conditions
Table 6. Electromagnetic Compatibility Conditions
Emission Test Compliance Electromagnetic
environment guidance
RF emissions
CISPR 11
Group 1 NA
RF emissions
CISPR 11
Class B The Warrior is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low voltage power
supply network that supplies buildings
used for domestic purposes.
Harmonic Emissions NA
Voltage Fluctuations NA
Warning: This equipment/system is intended for use by healthcare professionals only.
This equipment/system may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as re-
orienting or relocating the QiF device or shielding the location.
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