GE enFlow IV User guide

enFlow®
IV fluid and blood warmer
System manual

About this manual
This manual has been developed to provide the user with the information necessary to operate and maintain the enFlow IV uid/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. As
with any medical device, please consult your local medical director or governing agency for further information and requirements. If you have questions or
concerns regarding this manual or product, please contact Customer Service or Technical Support for assistance:
Customer Service
E-mail: gmb-medspec-[email protected]
Phone: [phone], option 1
Technical Support
Phone: [phone]
Manufactured for
Vital Signs, Inc. a GE Healthcare Company
20 Campus Road
Totowa, New Jersey 07512, USA
EC RE P GE Medical Systems SCS
283 rue de la Miniere,
78530 Buc, France
© 2015 General Electric Company – All rights reserved. All specications 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. Vital Signs, Inc., a General
Electric company, doing business as GE Healthcare.
4400-0024-EN Rev A

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Symbols used on the equipment
The following symbols may be viewed on any of the products or accessories that comprise the enFlow IV uid/blood warming system.
Symbol Symbol description Symbol Symbol description
LO T
Batch Code On
RE F Catalog Number O
SN
Serial Number
LATEX
Not made
with natural
rubber latex
Not Made With Natural Rubber Latex
NS N
National Stock No. (US Military) Expiration Date
2Single Use Only;
Do Not Re-Use Direct Current
STERIL
ER
Sterilized Using Irradiation Alternating Current
Keep Dry Type BF Applied Part, Debrillation-Proof
STERILIZ E
2Do Not Re-Sterilize Do Not Use if Package is Damaged
Caution Fuse
Temperature; Thermometer NON-PYROGENIC Non-Pyrogenic
Danger High Voltage
Note
This symbol indicates that additional information is being
provided.

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Electric Energy Eect or action in both directions away from reference point
(Open)
70˚C
-30˚C
Temperature Range Eect or action in both directions towards a reference point
(Close)
DEHP Not made with
Di(2-ethylhexyl) phthalate
In transport applications it is advised to cushion and insulate
the Warmer from the patient’s skin and apply the Warmer as
loosely as acceptable checking regularly for signs of potential
pressure-related injury
Manufacturer IP67 Degree of protection provided by enclosure, dust tight,
temporary water immersion
IP31 Degree of protection provided by enclosure, no ingress of
object > 2.5 mm diameter, protected against dripping water IP68 Degree of protection provided by enclosure, dust tight, continuous water immersion
Rx ONLY Caution: U.S. Federal law restricts this device to sale by or on
the order of a physician Surface may be hot
Consult Instructions for Use
Do not encase the Warmer with any external coverings like:
towels, sheets, blankets or drapes. Covering the Warmer
restricts the natural convection of heat.
xx
System Fault XX Low Battery
Lock or Password Required Unlock
Do Not Throw in Trash
The CE Mark is the manufacturer’s or importer’s mark of
conformity declaring compliance with all applicable directives
(Safety, EMC, Machinery, Medical and others).
C
CM
US
4005716
Intertek is accredited by OSHA as a NRTL, as well as by the
Standards Council of Canada. This mark indicates that the
product has been tested to CAN/CSA-C22.2 No. 60601-
1:2008 Ed 03, AAMI ES60601-1:2005, IEC 60601-1:2005 Ed
03, IEC 60601-1 -6:2010 Ed 3 and IEC 60601-1-8: 2006 Ed 2.
Mute the Audible‘High Priority Alarm’For 1 Minute

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Table of contents
Warnings.............................................................................................................................................................................................................................................. 6
Cautions............................................................................................................................................................................................................................................... 6
enFlow IV uid/blood warming system description ........................................................................................................................................................... 8
Indications for use................................................................................................................................................................................................................... 8
Clinical and training information....................................................................................................................................................................................... 8
Unpacking the enFlow IV uid/blood warming system..................................................................................................................................................... 9
To begin operation of the enFlow IV uid/blood warming system ............................................................................................................................... 9
enFlow Controller (Model 121 series) indicators and operation...................................................................................................................................12
Controller (Model 121 series)—Setup Instructions...................................................................................................................................................12
Controller Display..................................................................................................................................................................................................................12
enFlow Warmer (Model 100 series) indicators and operation.......................................................................................................................................13
Cleaning the enFlow IV uid/blood warming system components............................................................................................................................14
Caution......................................................................................................................................................................................................................................14
Cleaning the Warmer............................................................................................................................................................................................................15
Cleaning the Controller.......................................................................................................................................................................................................15
Storing the enFlow IV uid/blood warming system components...............................................................................................................................15
Servicing the enFlow IV uid/blood warming system components ...........................................................................................................................16
Instructions for replacing the Controller clock battery............................................................................................................................................16
Instructions for changing the Controller fuse.............................................................................................................................................................18
enFlow uid warming system temperature controls and alarms.................................................................................................................................19
Temperature control.............................................................................................................................................................................................................19
Audible/Visual alarm ............................................................................................................................................................................................................19
enFlow troubleshooting..............................................................................................................................................................................................................19
Electromagnetic interference ...........................................................................................................................................................................................19
Interference conrmation ..................................................................................................................................................................................................19
Interference reduction steps.............................................................................................................................................................................................19
enCheck®(Model 400) user guide.............................................................................................................................................................................................20
Cleaning the enCheck .........................................................................................................................................................................................................21
Appendix A: Technical specications......................................................................................................................................................................................22
Appendix B: Warmer fault code table .....................................................................................................................................................................................25
Appendix C: Warming system response by temperature................................................................................................................................................26
Appendix D: Parts list....................................................................................................................................................................................................................27
Appendix E: Preventative maintenance procedure...........................................................................................................................................................28
Appendix F: enFlow IV uid/blood warming system operational checklist—alternative method..................................................................38
Appendix G: enFlow IV uid/blood warming system operational checklist—enCheck Model 400 method...............................................39
Appendix H: Glossary....................................................................................................................................................................................................................40