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GE enFlow IV Operator's Manual
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GE enFlow IV Operator's Manual

GE enFlow IV Operator's Manual

Fluid / blood warming system
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enFlow
*
IV Fluid / Blood Warming System
Operator's Manual
Vital Signs
a GE Healthcare Company

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Summary of Contents for GE enFlow IV

  • Page 1 IV Fluid / Blood Warming System Operator’s Manual Vital Signs a GE Healthcare Company...

  • Page 2: About This Manual

    © 2012 General Electric Company – All rights reserved. All specifications subject to change without notice. GE, GE Monogram, and Vital Signs are trademarks of General Electric Company. * enFlow is a trademark of General Electric Company Enginivity, LLC., a subsidiary of Vital Signs, Inc.
  • Page 3 Symbols Used on the Equipment The following symbols may be viewed on the any of the products or accessories that comprise the enFlow IV Fluid/Blood Warming System. Symbol Symbol Description Symbol Symbol Description Batch Code Catalog Number Serial Number Not made with natural rubber latex National Stock No.
  • Page 4 System Fault XX Low Battery Lock or Password required Unlock The CE Mark is the manufacturer’s or importer’s mark of Do not throw in trash conformity declaring compliance with all applicable directives (Safety, EMC, Machinery, Medical and others). Interek is accredited by OSHA as a NRTL, as well as by the Standards Council of Canada.

  • Page 5: Table Of Contents

    CAUTIONS ............................. 7 UNPACKING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM ..........9 TO BEGIN OPERATION OF THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM ....... 9 ENFLOW CONTROLLER (MODEL 120 SERIES) INDICATORS AND OPERATION ....... 11 ENFLOW WARMER (MODEL 100 SERIES) INDICATORS AND OPERATION ....... 13 CLEANING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ....

  • Page 6: Enflow Iv Fluid/Blood Warming System Description

    IV Fluid/Blood Warming System Description The enFlow IV Fluid/Blood Warming System consists of the enFlow Warmer (Model 100 series), the enFlow Controller (Model 120 series), the enFlow Disposable Cartridge with or without IV Extension Set (Model 200 series). Within seconds, this Warming System delivers normothermic infusate to the patient at flow rates of Keep Vein Open (KVO) to 200 mL/min when input fluid temperature is 20 °C.

  • Page 7: Warnings

    WARNINGS  All IV fluid bags must be vented of air per IV fluid manufacturers’ directions prior to connecting to the infusion set. Standard IV line protocols for priming the complete infusion set, the enFlow Disposable Cartridge, and the extension set must be followed before connecting to a patient.
  • Page 8  Do not block the fan in the Controller as this may cause overheating.  Although the Warmer has been tested to insure it will survive a drop of 1 m (3.28 ft.), care should be taken that the device is not dropped to reduce the potential of damage. ...

  • Page 9: Unpacking The Enflow Iv Fluid/Blood Warming System

    Setting the clock to the local time is optional, but usually done on initial use. No changes in performance are affected by the clock’s setting. d) Connect the enFlow IV Fluid/Blood Warmer cable to the Controller. This action is accomplished in three steps: 1.
  • Page 10 3. Turn right to lock. (See arrows on label.) e) The rear mounted I/0 (ON/OFF) switch on the Controller turns the power on and off. Switch the Controller to ON. Upon startup, the Controller conducts a self-test. The power indicator illuminates green, the Controller display flashes “enFlow”, a short audible “Beep”...

  • Page 11: Enflow Controller (Model 120 Series) Indicators And Operation

    k) Do not wrap the Warmer in towels, sheets, blankets or drapes. Opening the Warmer covers immediately stops the heating but not the flow. m) To turn off the device, use the switch located at the rear of the controller. enFlow Controller (Model 120 series) Indicators and Operation Keypad Controller Display...
  • Page 12 Controller Display The Controller display continuously reflects the specific infusate temperature that the Warmer monitors and maintains. The various readouts that may be depicted on the Controller display are described in the following tabulation: Table 1: Controller Display: Normal Operating Model Activity Display Reads Display Color and...

  • Page 13: Enflow Warmer (Model 100 Series) Indicators And Operation

    enFlow Warmer (Model 100 series) Indicators and Operation The Warmer monitors and maintains the infusate temperature at 40 °C ± 2 °C . On the top of the Warmer, there are two status indicator lights (multicolored LEDs), which reflect the following: Power - indicates the power and operational status of the Warmer.
  • Page 14 Table 4: Indicator Status Status Warmer Disposable Power Temperature Audible Description Action Required Covers Cartridge Indicator Indicator Indicator Ready Open or None Flashing Unlit None Warmer unit has None Closed Green power, but is not every 3 heating seconds Power up Closed In place Red ½...

  • Page 15: Cleaning The Enflow Iv Fluid/Blood Warming System Components

    Refer to Appendix C for the chart on “Warming System Response versus Fluid Temperature”. Refer to Warnings for additional information. Cleaning the enFlow IV Fluid/Blood Warming System Components Caution Do not clean with:  ketones (MEK, acetone, etc.) or ...

  • Page 16: Storing The Enflow Iv Fluid/Blood Warming System Components

    Controller. If fluid ingress is detected, set the Controller aside for an extended period of time to allow it to dry. Storing the enFlow IV Fluid/Blood Warming System Components The Warmer and Controller should be stored in a clean, dust free environment. (See Appendix A) 4400-0024 enFlow Operator’s Manual EN Rev.

  • Page 17: Enflow Iv Fluid/Blood Warming System Operational Checklist

    IV Fluid/Blood Warming System Operational Checklist Warmer Serial No_________ Controller Serial No_________ Warming System Location/Identifier__________ Date: Procedure Instructions Pass Input Output Fail Temp Temp Inspection Ensure that all cords and connectors are in good condition and void of any cuts, cracks, or frays.

  • Page 18: Servicing The Enflow Iv Fluid/Blood Warming System Components

    The systems use current Surface Mount Technology (SMT) and materials. If service is required, it must be performed by Vital Signs – a GE Healthcare Company or one of its authorized agents. Service by others voids the warranty and transfers the liability for malfunctions of the device to the servicer.

  • Page 19: Appendix A: Technical Specifications

    Appendix A: Technical Specifications Warmer: 12.7 cm L x 6.6 cm W x 3.0 cm H, (5.0 in. L x 2.6 in. Size W x 1.2 in. H) Controller: 23.6 cm L x 16.8 cm W x 9.7 cm H, (9.3 in. L x 6.6 in.
  • Page 20 Continuous Note Electromagnetic Compatibility (EMC) The enFlow IV Fluid / Blood Warmer System has been tested and found to comply with the limits for medical devices as set forth in IEC 60601-1-2: (2001) and related standards. These limits are designed to provide reasonable protection against electromagnetic interference (EMI) in a typical medical installation.
  • Page 21 Guidance and Manufacturer’s Declaration - Emissions The enFlow 100 with enFlow 120 is intended for use in the electromagnetic environment specified below. The customer or user of the enFlow 100 with enFlow 120 should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –...
  • Page 22 D=(3.5/3V/m)(Sqrt P) 80 to 800 MHz D=(7/3V/m)(Sqrt P) 800 MHz to 2.5 GHz where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (3Vrms and 3V/m).
  • Page 23 Rain- Operational 1. Place an enFlow Power Supply /Controller in the rain chamber. 2. Connect the enFlow IV Fluid Warmer and the extended power cable to the power supply. 3. Turn “on” the power supply. 4. Expose to 1” of rain per minute in its left IV pole orientation for 10 minutes.

  • Page 24: Appendix B: Glossary

    Appendix B: Glossary enFlow IV Fluid/Blood The enFlow IV Fluid/Blood Warming System consists of three products: Warming System the Warmer (No. 980100), the Controller (No. 980121), and the Disposable Cartridge (No. 980200), which together form a system designed to warm intravenous fluids and blood products helping reduce hypothermic effects.

  • Page 25: Appendix C: Warming System Response By Temperature

    Appendix C: Warming System Response by Temperature Fluid Heater Temperature LED on Display on Controller Audible Temp Warmer Alarm 30 °C Active Blue Flashing 30°C Blue Flashing 31 °C Active Blue Flashing 31°C Blue Flashing 32 °C Active Blue Flashing 32°C Blue Flashing 33 °C Active...

  • Page 26: Appendix D: Parts List

    Appendix D: Parts List 980105VS Warmer 980121EU Controller 980200EU Disposable cartridge 980202EU Disposable cartridge with IV extension set 980305VS Warmer Holder 980309VS Warmer Cord Clip 980307 enCheck Alarm testing Tool 44000024 Operator’s manual (USA) 44000060 Service manual (electronic version only, not available in print) 44000120 enCheck Users Guide English(EN) 91000178...

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