Summary of Contents for Quality QIF-01-12
- Page 1 Warrior Extreme Blood and Fluid Warmer Model QIF-01-12 Instruction for Use (IFU) QIF-IFU-00001 Rev. A6 December 2022...
- Page 2 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 QIF-IFU-00001 Rev.
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Page 3: Table Of Contents
Table of Contents TABLE OF CONTENTS Indications for Use _________________________________________________________ 4 Intended Use ______________________________________________________________ 4 Package Contents __________________________________________________________ 4 System Description _________________________________________________________ 5 System Components ________________________________________________________ 6 Base Unit _________________________________________________________________________________ 6 Compact Disposable Unit _____________________________________________________________________ 6 Intended Users _____________________________________________________________________________ 7 Fluid Warming Capacity _____________________________________________________________________ 7 Preparing and Operating the System __________________________________________ 8 Charging the Battery ________________________________________________________________________ 8... -
Page 4: Indications For Use
Do not use the Warrior Extreme system before viewing training materials and carefully reading the following instruction for use! 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. -
Page 5: System Description
Warrior Extreme Blood and Fluid Warmer Instructions for Use System Description 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. -
Page 6: System Components
Warrior Extreme Blood and Fluid Warmer Instructions for Use System Components 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. -
Page 7: Intended Users
Warrior Extreme Blood and Fluid Warmer Instructions for Use System Components Inlet Luer Outlet Luer Connector to Base Unit or Extension Cable Figure 4. Compact Disposable Unit Base Unit Connecting Cable Figure 5. Base Unit connected to the 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... -
Page 8: Preparing And Operating The System
Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System sensors constantly measure the fluid temperature and adjust the power supplied to the heat exchanger accordingly. Preparing and Operating the System Charging the Battery The Warrior Extreme is powered by a researchable battery, which should be fully charged before use. -
Page 9: Preparing The System For Warming
Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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. - Page 10 Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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...
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Page 11: Connecting The Warrior Extreme To The Fluid Bag And Patient
Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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: •... - Page 12 Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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.
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Page 13: Warming Blood Or Intravenous Fluid Products
Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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”... -
Page 14: General Operation Instructions
Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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. -
Page 15: Battery Replacement During Administration
Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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. - Page 16 Warrior Extreme Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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.
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Page 17: System Notifications And Troubleshooting
Warrior Extreme Blood and Fluid Warmer Instructions for Use System Notifications and Troubleshooting 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. - Page 18 Warrior Extreme Blood and Fluid Warmer Instructions for Use Audio Description LCD Notification User Action (if required) Notification Fluid is hot! ''Fluid is Hot'' message might appear Fluid is warmer than due to flow irregularities (e.g. block, Tout: XX °C (YY °C) 41 °C back flow, large bubbles) or sudden The LCD blinks...
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Page 19: Specifications And Characteristics
Warrior Extreme Blood and Fluid Warmer Instructions for Use Specifications and Characteristics 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... -
Page 20: Environmental Conditions
Warrior Extreme Blood and Fluid Warmer Instructions for Use Specifications and Characteristics 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 &... - Page 21 Warrior Extreme Blood and Fluid Warmer Instructions for Use Specifications and Characteristics equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, and cables other than those specified 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.
- Page 22 Warrior Extreme Blood and Fluid Warmer Instructions for Use Specifications and Characteristics Voltage dips and 0 % UT for 0,5 Not required The Warrior EXTREME is cycle battery powered equipment. interruptions on power supply input lines IEC 0 % UT for 1 61000-4-11 cycle 70 % UT for...
- Page 23 Warrior Extreme Blood and Fluid Warmer Instructions for Use Specifications and Characteristics Proximity fields from RF wireless 450 MHz 28 V/m communications equipment 710 MHz 9 V/m 745 MHz 780 MHz 810 MHz 28 V/m 870 MHz 930 MHz 1720 MHz 1845 MHz 1970 MHz 2450 MHz...
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Page 24: Cleaning The System
Warrior Extreme Blood and Fluid Warmer Instructions for Use Cleaning the System Table 9. Recommended safety distances between portable and mobile RF telecommunications devices Recommended safety distances between portable and mobile RF telecommunications devices and the QiF Warrior Extreme blood and fluid warmer The QiF Warrior Extreme blood and fluid warmer is intended for use in an electromagnetic environment in which radiated RF disturbance variables are controlled. -
Page 25: System Precautions
Do not use this system until it is repaired or replaced by Quality in Flow Ltd., or one of its representatives h Always replace the Compact Disposable Unit when replacing a blood IV administration set. -
Page 26: Warnings
Warrior Extreme Blood and Fluid Warmer Instructions for Use Warnings k The Warrior Extreme requires a fully charged battery for its operation. The battery does not have a memory effect and may be recharged even though it has not been fully discharged. -
Page 27: Disclaimer And Warranty
Disclaimer and Warranty Disclaimer Quality in Flow Ltd. shall not be held responsible in any manner for any bodily injury and/or property damage arising from operation or use of the Warrior Extreme, other than that which adheres strictly to the instructions and safety precautions contained herein and in all supplements hereto. -
Page 28: Symbols And Legends
Warrior Extreme Blood and Fluid Warmer Instructions for Use Symbols and Legends Symbols and Legends Symbol Description Manufacturer Authorized representative in the European community Catalogue number Serial Number Warning Refer to instruction manual/booklet Defibrillation proof CF applied part Temperature limitation Do NOT reuse Use by YY/MM (meaning the end of the indicated month.