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
Page 7 of 28
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
Page 8 of 28
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
Page 9 of 28
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.