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QIF-IFU-00001 Rev. A6

December 2022

Warrior Extreme

Blood and Fluid Warmer

Model QIF-01-12

Instruction for Use (IFU)

Содержание QIF-01-12

Страница 1: ...QIF IFU 00001 Rev A6 December 2022 Warrior Extreme Blood and Fluid Warmer Model QIF 01 12 Instruction for Use IFU...

Страница 2: ...is 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...

Страница 3: ..._____________________________________________ 14 Self Test_________________________________________________________________________________ 14 Stopping the Warrior Extreme device Fluid Blood Warming _...

Страница 4: ...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 t...

Страница 5: ...rrior 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 Th...

Страница 6: ...ng 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...

Страница 7: ...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...

Страница 8: ...rger 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 th...

Страница 9: ...osable 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 Disposab...

Страница 10: ...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...

Страница 11: ...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 th...

Страница 12: ...atient 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 nece...

Страница 13: ...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...

Страница 14: ...le 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 flu...

Страница 15: ...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 r...

Страница 16: ...ng 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 Initiali...

Страница 17: ...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...

Страница 18: ...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 9...

Страница 19: ...ry 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 join...

Страница 20: ...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 Electromagne...

Страница 21: ...maintaining basic safety and essential performance with regard to electromagnetic disturbances for the expected service life provided in table 7 Essential performance of the QiF device is that the out...

Страница 22: ...ospital environment IEC 61000 4 8 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...

Страница 23: ...from RF wireless communications equipment 450 MHz 28 V m 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 5240 MHz 9 V m 5500 MHz 5785 MHz IEC 61000 4...

Страница 24: ...74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended distance can be determined using the equation applicable t...

Страница 25: ...the Warrior Extreme reusable parts 10 System Precautions a Do not use the Warrior Extreme if the audio and or visual indications are not functioning b For blood blood product intravenous fluid infusio...

Страница 26: ...rming 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 an output temperature lower than 38 2 C c Do not use the Warrior Ext...

Страница 27: ...d 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 here...

Страница 28: ...efibrillation proof CF applied part Temperature limitation Do NOT reuse YY MM Use by YY MM meaning the end of the indicated month i e 20 03 is valid until March 2020 Do NOT re sterilize Sterilized usi...

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