GE enFlow IV System Manual
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GE enFlow IV System Manual

Fluid and blood warmer
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IV fluid and blood warmer
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Summary of Contents for GE enFlow IV

  • Page 1 enFlow ® IV fluid and blood warmer System manual...
  • Page 2 About this manual This manual has been developed to provide the user with the information necessary to operate and maintain the enFlow IV fluid/blood warming system. It is important that all medical personnel that operate this device read and understand all the information contained within this System Manual. This material is not meant as a substitute for formal training in the use of intravenous delivery systems, which may be required by local, regional or state protocol.
  • Page 3 Symbols used on the equipment The following symbols may be viewed on any of the products or accessories that comprise the enFlow IV fluid/blood warming system. Symbol Symbol description Symbol Symbol description LO T Batch Code Catalog Number RE F...
  • Page 4 Effect or action in both directions away from reference point Electric Energy (Open) Effect or action in both directions towards a reference point 70˚C Temperature Range (Close) -30˚C In transport applications it is advised to cushion and insulate Not made with the Warmer from the patient’s skin and apply the Warmer as DEHP Di(2-ethylhexyl) phthalate...

  • Page 5: Table Of Contents

    Appendix D: Parts list ............................................27 Appendix E: Preventative maintenance procedure ................................28 Appendix F: enFlow IV fluid/blood warming system operational checklist—alternative method ..............38 Appendix G: enFlow IV fluid/blood warming system operational checklist—enCheck Model 400 method ..........39 Appendix H: Glossary ............................................40 4400-0024-EN Rev A...

  • Page 6: 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. Care must be taken to ensure there is not sufficient air in the fluid bag and lines to cause an air embolism.
  • Page 7 Due to highly stable components, microprocessor control, and built-in self-tests, an annual performance check is sufficient. • The steps listed in the enFlow IV fluid/blood warming system operational checklist (Appendix F) should be performed at least once a year, or as required by your accrediting body.

  • Page 8: 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 121 series), the enFlow Disposable Cartridge with IV extension set (Model 202) or without IV extension set (Model 200). Within seconds, this warming system delivers normothermic infusate to the patient at flow rates of Keep Vein Open (KVO defined as 2 mL/min) to 200 mL/min when input fluid temperature is 20 °C.

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

    Unpacking the enFlow IV fluid/blood warming system Upon receipt of the enFlow IV fluid/blood warming system components, visually inspect the shipping containers and internal contents for damage that may have occurred during shipment. If there is any visible or mechanical damage to the contents, or if the order is incomplete, please contact Customer Service immediately.
  • Page 10 POWER 40°C 2:20 P Controller Model 121 40°C 2:20 P 40°C 2:20 P b. Plug the Controller into a hospital grade outlet. c. 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. (Please refer to the “enFlow Controller (Model 121 series) indicators and operations”...
  • Page 11 h. Completely close the covers on the Warmer by pressing down on the cartridge and sliding the covers inward toward each other until they meet. Upon closing the covers, a short audible beep occurs indicating that the Warmer self-test is being performed and confirms operation of temperature sensors and alarm indicators.

  • Page 12: Enflow Controller (Model 121 Series) Indicators And Operation

    enFlow Controller (Model 121 series) indicators and operation Keypad 40°C Controller Display 2:20 P Female Receptacle for Power Indicator Warmer Connector Controller (Model 121 series)—setup instructions 1. Set the clock a. To modify the initial default mode of the Controller, press the center button of the front keys of the display window prior to pushing the power switch that is located in the back of the unit.

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

    Table 1—Controller Display: Normal Operating Model Activity Display reads Display color and function Warmer is connected and power is engaged. Temperature and Clock Identical to Warmer 40 °C temperature LED 9:00 A Warmer is not connected, but Controller is powered on. Not Heating Yellow Warmer is connected, but covers are open on Warmer.

  • Page 14: Cleaning The Enflow Iv Fluid/Blood Warming System Components

    Warmer if this occurs, and contact Technical Support. Refer to Appendix C for the chart on “Warming system response by 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.)

  • Page 15: Cleaning The Warmer

    3. Wipe the surface of the Controller, taking care not to leave excess residual cleaner on the 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)

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

    Servicing the enFlow IV fluid/blood warming system components The enFlow IV fluid/blood warming system components have been designed to be durable and long lasting. The system uses current Surface Mount Technology (SMT) and materials. If a System Fault error occurs, then remove the device from service and refer to the table in Appendix B for proper evaluation and handling.
  • Page 17 1. Turn Controller over. Diagram 1 Diagram 2 Controller Model 121 2. To remove the bottom, unscrew pole clamp screw; unscrew six (6) screws shown below. Next, lift the cover. Diagram 3 Diagram 4 Screw_1 Screw_2 Pole Clamp Screw Screw_4 Screw_3 Screw_5 Screw_6...

  • Page 18: Instructions For Changing The Controller Fuse

    4. Remove display panel a. On the display panel, remove the four (4) screws at the end of the panel next to the display screen (see Diagram 7). b. Pull the display panel away from the fan assembly. c. With pliers, gently pull out battery. d.

  • Page 19: Enflow Fluid Warming System Temperature Controls And Alarms

    Temperature control The enFlow IV fluid/blood warming system includes multiple safety features to prevent overheating of infusion fluids. There are built-in redundancies and back-up safety systems as means for protection in the event of a failure in the primary control mechanism. Several aspects of the system work together to accomplish desired and appropriate safety: 1.

  • Page 20: Encheck (Model 400) User Guide

    Confirm the enFlow and the ECG monitor are plugged into different outlets There are two reasons for this action. It is possible that the two systems are in an electrical phase related conflict, which is being expressed on the monitor. Secondly, it is possible that the outlets are not properly grounded or grounded in different locations.

  • Page 21: Cleaning The Encheck

    Relative Humidity Range: 10% to 90% Cleaning the enCheck 1. Use only approved cleaning solutions. (Please reference “Cleaning the enFlow IV fluid/blood warming system components” for a list of approved cleaning solutions.) 2. Moisten a clean cloth with the cleaning solution; do not spray or pour cleaning solutions directly onto the enCheck.

  • Page 22: Appendix A: Technical Specifications

    Note: Electromagnetic Compatibility (EMC) The enFlow IV fluid/blood warming system has been tested and found to comply with the limits for medical devices as set forth in IEC 60601-1-2: (2014) and related standards. These limits are designed to provide reasonable protection against electromagnetic interference (EMI) in a typical medical installation.
  • Page 23 Guidance and Manufacturer’s Declaration – Emissions The enFlow 100 with enFlow 121 is intended for use in the electromagnetic environment specified below. The customer or user of the enFlow 100 with enFlow 121 should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –...
  • Page 24 Guidance and Manufacturer’s Declaration – Emissions The enFlow 100 with enFlow 121 is intended for use in the electromagnetic environment specified below. The customer or user of the enFlow 100 with enFlow 121 should ensure that it is used in such an environment. Immunity Test EN/IEC 60601 Compliance...

  • Page 25: Appendix B: Warmer Fault Code Table

    Please follow these instructions if any of the fault conditions listed above are displayed on the controller: 1. Thoroughly clean the warmer using the instructions provided in this manual (refer to section titled “Cleaning the enFlow IV fluid/blood warming system components.

  • Page 26: Appendix C: Warming System Response By Temperature

    Appendix C: Warming system response by temperature Fluid Temp Heater Temperature LED on Warmer Display on Controller Audible 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...

  • Page 27: Appendix D: Parts List

    Appendix D: Parts list Part number Part Part number Instructions For Use 980105VS Warmer 44000024 System Manual (USA) 980105INT Warmer (International) 44000073 Instructions For Use German (DE) 980121EU Controller 44000074 Instructions For Use Danish (DA) 980121VSD Domestic only controller 44000075 Instructions For Use Spanish (ES) 980105VSD Domestic only warmer...

  • Page 28: Appendix E: Preventative Maintenance Procedure

    Appendix E: Preventive maintenance procedure Employ local regulations to determine the frequency of required testing (i.e. Earthing Impedance, Leakage Current) for the enFlow Warmer (Model 100) and Controller (Model 121). Frequency Functional and Operational Testing Protocols As required by accrediting body or once a year Inspections Temperature Readout Display and Status Indicator Lights Electrical Safety...
  • Page 29 2. Leakage current at the AC power cord Equipment Safety analyzer with test lead enFlow Controller Purpose This test is run to check the chassis leakage in microamps. For the purpose of this test, the Controller is the chassis. Procedure 1.
  • Page 30 Purpose The purpose of this test is to check the leakage of current from the Warmer into saline. As IV fluids are generally conductive, a fluid warmer is considered to be electrically connected to the patient similar to an ECG lead; therefore, the leakage needs to be tested. The setup for this procedure is described below. Safety Analyzer Wire Procedure...
  • Page 31 Purpose The enCheck Tester was developed to quickly and reliably trigger the over-temperature alarm condition on the enFlow Warmer. Within seconds, the enCheck unit will heat the Warmer to an over- temperature scenario causing the alarm to sound. Additionally, the enCheck is designed to verify the Warmer operation at enFlow’s installation site.
  • Page 32 : If the temperature in step 8 above is not 40 °C ± 2 °C, take the Warmer unit out of service. Call Customer Service for an RGA. Please reference the RGA section in “Servicing the enFlow IV fluid/blood warming system components” for further information regarding returns.
  • Page 33 B. Alternative method Equipment enFlow system Power source Infusion pump capable of maintaining up to 200 mL/min IV line set Water bath Source of distilled water or normal fluid - 0.5 L at 20 °C ± 2.0 °C 2 extension sets - 22.9 cm (9 in) Thermometer - capable of measuring 10 °C to 60 °C accurate to ±...
  • Page 34 W ater source 20 °C Power source Pump mL/min IV Line set T em perature probe inserted into enFlow extension set. Controller Extension set enFlow W arm er Extension set T em perature probe inserted into extension set. T herm om eter W aste water container Procedure...
  • Page 35 6. Insert the enCheck unit into the Warmer so the bottom end of the unit is keyed similarly as the Warmer Cartridge, so that it only fits in the correct orientation (curved section on the left side), and close the Warmer covers. 7.
  • Page 36 W ater source 50 °C Power source Pump mL/min IV Line set T em perature probe inserted into enFlow extension set. Controller Extension set enFlow W arm er Extension set T em perature probe inserted into extension set. T herm om eter W aste water container 3.
  • Page 37 Preventative Maintenance Checklist Warmer Controller Initial Serial No. Serial No. and date Pass Pass Pass Pass Pass Pass Pass Pass Fail Fail Fail Fail Fail Fail Fail Fail Pass Pass Pass Pass Pass Pass Pass Pass Fail Fail Fail Fail Fail Fail Fail...

  • Page 38: Appendix F: Enflow Iv Fluid/Blood Warming System Operational Checklist-Alternative Method

    Appendix F: enFlow IV fluid/blood warming system operational checklist—alternative method Warmer Serial No Controller Serial No Warming system location/identifier Date Procedure Instructions Pass/Fail Input Temp Output Temp Inspection Ensure all cords and connectors are in good condition and void of any cuts, cracks, or frays.

  • Page 39: Appendix G: Enflow Iv Fluid/Blood Warming System Operational Checklist-Encheck Model 400 Method

    Appendix G: enFlow IV fluid/blood warming system operational checklist—enCheck Model 400 method Warmer Serial No Controller Serial No Warming system location/identifier Date Procedure Instructions Pass/Fail Temperature Inspection Ensure all cords and connectors are in good condition and void of any cuts, cracks, or frays.

  • Page 40: Appendix H: Glossary

    Appendix H: Glossary enFlow IV fluid/blood warming system The enFlow IV fluid/blood warming system consists of three products: the Warmer (No. 980105VS), the Controller (No. 980121EU), and the Disposable Cartridge (No. 980202EU/980200EU), which together form a system designed to warm intravenous fluids and blood products to reduce hypothermia.

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