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GE Vital Signs enFlow Service Manual
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GE Vital Signs enFlow Service Manual

GE Vital Signs enFlow Service Manual

Iv fluid / blood warming system
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IV Fluid / Blood Warming System
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Summary of Contents for GE Vital Signs enFlow

  • Page 1 enFlow IV Fluid / Blood Warming System Service Manual...
  • Page 2 © 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 Symbol Symbol Description Symbol Symbol Description The following symbols may be viewed on the any of the products or accessories that comprise the enFlow IV Fluid/Blood Warming System. 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). Not Heating Heating, Normal Operation Alarm Muted (for an intermittent time Press Any Key to Mute Alarm.

  • Page 5: Table Of Contents

    TABLE OF CONTENTS ENFLOW IV FLUID/BLOOD WARMING SYSTEM DESCRIPTION ........6 INDICATION FOR USE ......................7 CLINICAL AND TRAINING INFORMATION ................7 WARNINGS ..........................8 CAUTIONS..........................8 CLEANING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ..10 STORING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ..11 SERVICING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ..

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

    enFlow IV Fluid/Blood Warming System Description The enFlow IV Fluid/Blood Warming System consists of the enFlow Warmers (Model 100 series, the enFlow Controller/AC Power Pack (Model 120 series), the enFlow AC Power Pack (Model 120 series), the enFlow Disposable Cartridge with or without an 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: Indication For Use

    Additionally, another portable source of power compatible with the enFlow Warming System is the Battery Pack (Model 300 series). (For further information on this item please reference the Energy I Operator’s Manual.) Each Disposable Cartridge and the Disposable Disposable Cartridge with extension set are radiation sterilized and non-pyrogenic as well as latex and DEHP free.

  • Page 8: 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 9  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.  Do not clean with: o ketones (MEK, acetone, etc.) or o abrasive cleaners.

  • Page 10: Cleaning The Enflow Iv Fluid/Blood Warming System Components

    Cleaning the enFlow IV Fluid/Blood Warming System Components Caution Do not clean with:  ketones (MEK, acetone, etc.) or  abrasive cleaners. Do not sterilize the Warmer with:  steam sterilization (autoclave) or  dry heat. Do not disinfect or sterilize the Controller. Do not spray or pour cleaning solutions directly on the Controller.

  • Page 11: Storing The Enflow Iv Fluid/Blood Warming System Components

    Goods Authorization (RGA) number from Vital Signs, Inc. No Product may be returned without an RGA number. Our Customer Service Representatives can be reached by phone at (+1 973.956.5431) or by e-mail at vitalsignscustomerservice@ge.com. The Technical Support Representative will troubleshoot your Product issue with you on the phone. If it is necessary to return a Product under warranty, a replacement loaner will be shipped to you within 48 hours.

  • Page 12: Controller/Ac Power Pack (Model 120 Series) - Setup Instructions

    Caution Normal wear and tear during use of the Warmer may cause the device to be susceptible to fluid ingress. Carefully inspect the heating surface of the Warmer for tears or foreign matter before each use and take out of service if necessary. For information on safety checks, please see Appendix F: Preventive Maintenance Procedure.
  • Page 13 Instructions for replacing the Controller/AC Power Pack clock battery. 1. Turn Controller/AC Power Pack over. Diagram 1 Diagram 2 2. To remove the bottom, unscrew Pole Clamp screw; unscrew 4 screws shown below. Next, lift the cover. Diagram 3 Diagram 4 3.
  • Page 14 4. Display Panel a. On the display panel remove the two screws (4 and 5) at the end of the panel next to the display screen (see Diagram 7). b. There are three other screws (1-3) that need to be loosened half-way on this panel. c.

  • Page 15: Enflow Fluid Warming System Temperature Control And Alarms

    Instructions for changing the Controller/AC Power Pack or AC Power Pack fuse. 1. Insert a screwdriver on either side of the fuse box and push gently to pop the fuse case out of its socket. Fuses Fusecase 2. Pull the broken fuse out of the case. 3.

  • Page 16: Enflow Troubleshooting

    enFlow Troubleshooting Electromagnetic Interference  ECG, EEG or EMG (cardiac or neuro monitoring) artifact or other interference caused by the enFlow is an uncommon event.  Cardiac or neuro monitoring interference is common and well documented in the medical literature. ...
  • Page 17 If the current mode is set on “Diagnostic” consider adjusting it to “Monitoring”. Check the ECG pads impedance. Contact your current supplier of monitoring pads or your local GE Healthcare representative to determine if a lower impedance version is available. High impedance monitoring pads are less sensitive to the very low signal strength from the heart beat and appear to be more prone to pronounced interference.

  • Page 18: 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 19 Vibration MIL-STD-810F Radiated Magnetic Field Emissions MIL-STD 461D, RE101 (7 cm test limit 30 Hz-100Khz); EMC IEC 60601-1-2:2007 Safety Classifications Type of protection against electrical Class I, or Internally Powered shock Degree of protection against electric Type BF, Defibrillation-Proof shock Mode of operation Continuous Note...
  • Page 20 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 21 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 22 interruptions, it is recommended that 30% Dip for 30% Dip for the enFlow 100 with enFlow 120 be 25 Cycles 25 Cycles powered from an uninterruptible power supply or battery. >95% Dip for See Note 1 5 Seconds Power Frequency 3 A/m 3 A/m Power frequency magnetic fields...
  • Page 23 Controller: IEC 529 IP2X ≥ 12.5 diameter Testing 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.

  • Page 24: Appendix B: Warmer Fault Code Table

    Appendix B: Warmer Fault Code Table Warmer Fault Code Table Displayed on Controller/AC Power Pack Name Description Fluid out temperature sensor reading failure Sensor is reading a temperature outside the normal operating range or has been determined to be open or shorted. Fluid in temperature sensor reading failure Sensor is reading a temperature outside the normal operating range or has been determined...

  • Page 25: Appendix C: Glossary

    Appendix C: Glossary enFlow IV Fluid/Blood The enFlow IV Fluid/Blood Warming System consists of three products: Warming System the Warmer (Model 100 series), the Controller/AC Power Pack (Model 120 series), and the Disposable Cartridge (Model 200 series), which together form a system designed to warm intravenous fluids and blood products helping reduce hypothermic effects.

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

    Appendix D: 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 27: Appendix E: Parts List

    Appendix E: Parts List 980105VS Warmer 980121EU Controller 980200EU Disposable cartridge 980202EU Disposable cartridge with IV extension set 380304EU enFlow warmer strap 980305VS Warmer holder 980309VS Warmer cord clip 980307 enCheck Alarm testing Tool 44000060 Service manual (electronic version only, not available in print) 44000108 Preventive Maintenance Record English (EN) (electronic version only, not available in print) 44000120...

  • Page 28: Appendix F: Preventive Maintenance Record

    Appendix F: Preventive Maintenance Record Employ local regulations to determine the frequency of required testing (i.e. Earthing Impedance, Leakage Current) for the enFlow Warmer (Model 100), Controller/AC Power Pack (Model 121), and AC Power Pack. Frequency Functional and Operational Testing As required by As required by Protocols...
  • Page 29 4. Plug the power cord of the Controller/AC Power Pack into the safety analyzer. 5. Set the function knob on the safety analyzer to Ground wire resistance. 6. Set the ground switch to normal. 7. Set the polarity switch to the off position. 8.
  • Page 30 Procedure 1. Leave the cap on the female end of the cartridge. 2. Put an extension set on the male end. 3. Insert a piece of wire into the extension set tubing. 4. Fill the cartridge and extension set tubing with saline. Note: it doesn’t matter which way the wire is inserted into the tubing just be certain that the wire is in contact with the fluid.
  • Page 31 B. Overheat Mode – Alarm Test When operated in the overheat mode, the heat is generated from the contact plate on the underside of the enCheck unit. The enCheck heats the Warmer to > 45 °C. This temperature range simulates an over-temperature situation demonstrating the functionality of the alarm (audible, LED’s, and display (Controller only).
  • Page 32 Procedure Measure Input and Output Temperatures of Fluid 1. Set up the enFlow system for normal operation. (See Operator’s Manual “To Begin Operation of the enFlow IV Fluid/Blood Warming System”.) 2. Attach an IV line set to a 0.5 liter source of fluid at a temperature of ≈ 20 °C ± 2 °C. Then run the IV line through a pump capable of maintaining up to 200 mL/min.
  • Page 33 Purpose The purpose of this test is to determine that the over-temperature alarm on the Warmer is working properly. Procedure 1. Use the performance testing setup described in steps 1- 5 above. 2. Use a clamp to stop the flow in the IV line. 3.
  • Page 34 Blank page enFlow Service Manual Rev. F 04/12 4400_0060 Page 34 of 36...
  • Page 35 Controller Warmer Serial Serial Initial and Date Pass Pass Pass Pass Pass Pass Pass Pass Pass Fail Fail Fail Fail Fail Fail Fail Fail Fail enFlow Service Manual Rev. F 04/12 4400_0060 Page 35 of 36...
  • Page 36 enFlow Service Manual Rev. F 04/12 4400_0060 Page 36 of 36...

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