Related Manuals for QinFLOW Warrior QiF-01-12
Summary of Contents for QinFLOW Warrior QiF-01-12
- Page 1 Warrior Blood and Fluid Warmer Model QiF-01-12 Instruction for Use (IFU) QPORT1700 Rev. A15 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 QPORT1700 Rev.
-
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
Indications for Use QinFlow (QiF) Blood and Fluid Warmer device (the “Warrior”) 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 Blood and Fluid Warmer Instructions for Use System Description System Description What is the Warrior Blood and Fluid Warmer? The Warrior Blood and Fluid Warmer is an inline, battery-powered, lightweight and completely portable system, for warming blood, blood product and IV fluids. The Warrior 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 ±... -
Page 6: System Components
Warrior Blood and Fluid Warmer Instructions for Use System Components System Components The Warrior 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
Fluid bag Warrior Blood and Fluid Warmer Instructions for Use System Components Inlet Luer Outlet Luer Connector to Base Unit or Extension Cable Figure 3. Compact Disposable Unit Fluid bag Base Unit Connecting Cable Compact Disposable Unit Figure 4. Base Unit connected to the Compact Disposable Unit Intended Users Who should use the Warrior Blood and Fluid Warmer? The Warrior should only be used by qualified healthcare professionals that have read the... -
Page 8: Preparing And Operating The System
Warrior Blood and Fluid Warmer Instructions for Use Preparing and Operating the System When using a fully charged battery, at flow rate of 160–180 ml/min, the Warrior can warm up to three liters of parenterally administrated fluid with an inlet temperature of 4 °C (39.2 °F). -
Page 9: Preparing The System For Warming
Warrior Blood and Fluid Warmer Instructions for Use Preparing and Operating the System When placed in long storage, charge the batteries every 4-6 months. WARNING: Never throw the Warrior battery into the trash. The battery should be disposed of at a designated battery disposable collection point. 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... -
Page 10: Connecting The Base Unit To The Compact Disposable Unit
Warrior Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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 top side of the cable connector is next to the protrusions on top of the Compact Disposable Unit Connect the Base Unit cable to the Compact Disposable... -
Page 11: Connecting The Warrior To The Fluid Bag And Patient
Warrior Blood and Fluid Warmer Instructions for Use Preparing and Operating the System Connecting the Warrior to the Fluid Bag and Patient The Warrior 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 ±... - Page 12 Warrior 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 was not validated. Note: The Compact Disposable Unit is a single use item, supplied sterile and ready for use.
-
Page 13: Warming Blood Or Intravenous Fluid Products
Warrior 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: Self-Test
Warrior Blood and Fluid Warmer Instructions for Use Preparing and Operating the System Self-Test 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. -
Page 15: Battery Replacement During Administration
Warrior Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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 25—30% capacity Pay attention, a ''Battery Empty'' getting Low! - Page 16 Warrior Blood and Fluid Warmer Instructions for Use Preparing and Operating the System 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 the Base Unit label. If you insert the battery in the wrong orientation, the battery will not dock with the Base Unit.
-
Page 17: System Notifications And Troubleshooting
Warrior 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 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...
-
Page 19: Specifications And Characteristics
Warrior 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 22 VDC from a fully charged battery... -
Page 20: Electromagnetic Compatibility (Emc) Conditions
Warrior Blood and Fluid Warmer Instructions for Use Specifications and Characteristics 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**** IP33 The Base Unit does not require any calibration or maintenance. - Page 21 Warrior Blood and Fluid Warmer Instructions for Use Specifications and Characteristics Essential performance of the QiF device is that the outflow temperature stabilizes on 38 ± 2 °C (100.4 ± 3.6 ºF). QiF device shall only be used with the cables provided by the manufacturer. Base Unit cable length is 90cm (approximately 34 in.);...
- Page 22 Warrior Blood and Fluid Warmer Instructions for Use Specifications and Characteristics NOTE: UT is the AC mains voltage prior to application of the test level. Table 8. Electromagnetic interference resistance Immunity test IEC 60601 level Compliance level IEC 61000-4-6 3 Vrms [V] = 3 Vrms Conducted RF 150 kHz to 80 MHz...
- Page 23 Warrior Blood and Fluid Warmer Instructions for Use Specifications and Characteristics 5240 MHz 9 V/m 5500 MHz 5785 MHz IEC 61000-4-39 8 A/m 8 A/m Immunity to magnetic fields in 30 kHz 30 kHz close proximity 65 A/m 65 A/m 134.2 kHz 134.2 kHz 7.5 A/m...
-
Page 24: Cleaning The System
Warrior Blood and Fluid Warmer Instructions for Use Cleaning the System Cleaning the System Cleaning the Compact Disposable Unit The CDU is provided sterile and ready for use. The CDU is a single patient use item; do not reuse it! WARNING: Do not submerge, sterilize or autoclave the CDU. -
Page 25: System Precautions
Warrior Blood and Fluid Warmer Instructions for Use System Precautions System Precautions a Do not use the Warrior if the audio and/or visual indications are not functioning. b For blood / blood product / intravenous fluid infusion instructions, refer to your facility/organization protocol. -
Page 26: Warnings
The Warrior is manufactured by Quality in Flow Ltd. and is warranted to be free from manufacturer defects. The system is covered for one year from date of purchase. For support & service and information contact: support@qinflow.com. QPORT1700 Rev. A15... -
Page 27: Symbols And Legends
Warrior 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.
Need help?
Do you have a question about the Warrior QiF-01-12 and is the answer not in the manual?
Questions and answers