GE enFlow IV Operator's Manual

*

Vital Signs

a GE Healthcare Company

enFlow

IV Fluid / Blood Warming System

Operator’s Manual

About this Manual

This Operator’s 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 Operating 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 one of the following for assistance:

Customer Service

E-mail: [e-mail]
Phone: [phone], option 1

Technical Support

Phone: [phone]
FAX: [phone]

Service Center Address:

Vital Signs
20 Campus Road
Totowa, New Jersey, 07512 USA

GE Medical Systems SCS,
283 rue de la Miniere,
78530 BUC, FRANCE
Tel: [phone]
Fax: [phone]

Vital Signs, Inc.
a GE Healthcare Company
20 Campus Road
Totowa, New Jersey, 07512, USA

© 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.
Vital Signs, Inc., a General Electric company, doing business as GE Healthcare.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 2 of 26

Symbol

Symbol Description

Symbol

Symbol Description

Batch Code

On

Catalog Number

Off

Serial Number

Not made with natural rubber latex
National Stock No. (US Military)

Expiration Date

Single Use Only; Do Not Re-Use

Direct Current

Sterilized Using Irradiation

Alternating Current

Keep Dry

Type BF applied part, defibrillation-proof

Do Not Re-Sterilize

Do Not Use if Package is Damaged.

ATTENTION

Fuse

Temperature; Thermometer

Non-Pyrogenic

Danger High Voltage

Note

This symbol indicates that additional information is
being provided.

Electric Energy

Effect or action in both directions away from reference
point. (Open)

Storage Temperature Range

Effect or action in both directions towards a reference
point. (Close)

Di(2-ethylhexyl) phthalate Free

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

IP21

Degree of protection provided by
enclosure, no ingress of object > 12.5
mm diameter, protected against
dripping water

IP68

Degree of protection provided by enclosure, dust tight,
continuous water immersion

Caution: U.S. Federal law restricts this
device to sale by or on the order of a
physician.

TUV Rheinland of North America, Inc. 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 UL 60601-1:2003 R6.03, CAN/CSA-C22.2 No.

601.1-M90, IEC 60601-1-1:2000, and IEC 60601-1­4:2000.

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.

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.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 3 of 26

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).

Interek 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/CSA­C22.2 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.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 4 of 26

TABLE OF CONTENTS

ENFLOW® IV FLUID/BLOOD WARMING SYSTEM DESCRIPTION ................................................... 6

INDICATION FOR USE ......................................................................................................................... 6

CLINICAL AND TRAINING INFORMATION ....................................................................................... 6

WARNINGS ........................................................................................................................................... 7

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 .................... 15

STORING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ....................... 16

ENFLOW IV FLUID/BLOOD WARMING SYSTEM OPERATIONAL CHECKLIST ........................... 17

SERVICING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ................... 18

APPENDIX A: TECHNICAL SPECIFICATIONS .................................................................................. 19

APPENDIX B: GLOSSARY .................................................................................................................. 23

APPENDIX C: WARMING SYSTEM RESPONSE BY TEMPERATURE ............................................. 25

APPENDIX D: PARTS LIST ................................................................................................................. 26

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 5 of 26

enFlow 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.

The Warmer is the reusable heating unit designed to work in conjunction
with the Disposable Cartridge. Two multicolored light emitting diode (LED)
indicators on the Warmer indicate its power status and the fluid/blood
infusate temperature. The infusate within the Disposable Cartridge is
warmed when in contact with the heating surface of the Warmer. This surface is heated by means
of electrical resistance. The Warmer contains redundant temperature sensors to help ensure fluid
temperature accuracy and reliability. It also includes two independent over-heating protectors.
Continuous internal diagnostics monitor essential components and system parameters when
heating fluid/blood.

The Controller serves as a power supply for the Warmer unit. The
Controller is designed to mount on an IV pole or sit on a table top.
The front panel includes a Controller reading in degrees Celsius, as
well as a keypad, which controls the clock and the mute feature.
The Controller display is always shown “right-side-up”.

Each Disposable Cartridge and the Disposable Cartridge with IV
extension set are radiation sterilized and non-pyrogenic as well as
latex and DEHP free. The Disposable Cartridge connects to the IV
Extension Set or any infusion set employing standard luer connectors.
Once primed, the Disposable Cartridge in conjunction with the
Warmer and the Controller combine to complete the enFlow IV
Fluid/Blood Warming System.

Indication for Use

The enFlow IV Fluid/Blood Warming System’s intended use is for warming blood, blood products and
intravenous solutions prior to administration. It is designed to be used by healthcare professionals in
hospital, clinical and field environments to help prevent hypothermia.

Clinical and Training Information

Operators must be trained to set up and deliver blood/ IV solutions in a medically approved manner,
including aseptic techniques and standard hospital procedures. Use of the enFlow IV Fluid/Blood
Warming System, when properly administered, will help to prevent hypothermia and the
complications arising therefrom.

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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.

 The 'High Priority Alarm' is a flashing RED LED, a flashing RED Controller display, and an

audible alarm, indicating that the infusate is over temperature. Stop the fluid flow, and
slide the Warmer covers open to stop warming. If the above occurs, then replace the
Warmer and contact Technical Support. The attending practitioner should remain within
4m of the patient when the device is in use to enable visualisation of the enFlow display
and hear the audible high priority alarm.

 The Warmer contains magnets; do not operate within 15 cm (6 in.) of a pacemaker or

other devices that may be sensitive to strong magnetic fields.

 The Disposable Cartridge may be a potential biohazard during or after use. Handle and

dispose of in accordance with acceptable medical practice and applicable regulations.

 Do not use in the presence of flammable anesthetics.
 Replace the fuses with only Bussmann

registered in the United States or abroad by Cooper Industries, Inc. or its subsidiaries.

 The Disposable Cartridge should not be used for greater than 24 hours.
 Ensure that the Disposable Cartridge expiration date has not passed.
 If the IV line runs dry, disconnect the Disposable Cartridge from the Warmer. Re-prime

the entire IV system using aseptic techniques. Ensure all the air is removed from both the
line and the Disposable Cartridge. Replace the Disposable Cartridge in the Warmer.

 The enFlow Warmer is to be used only with approved enFlow power sources and the

enFlow Disposable Cartridge.

 To avoid risk of electric shock, this equipment must only be connected to a supply main

that is grounded. Should the need arise the device may be disconnected by the appliance
coupler.

®

part # GDB 5A or equivalent. Bussmann® is

Cautions

 Follow the AABB "Guidelines for the Use of Blood Warming Devices" (© 2006) which caution

against warming when administering platelets, cryoprecipitate, or granulocyte suspensions.

 Some drugs or drug preparations may be sensitive to warming. As with any fluid or blood

warming system, carefully review the drug manufacturer's literature for information about
thermal sensitivity.

 The disposable cartridge contains aluminum. Review the preparation or solution

manufacturer's instructions for use about chemical sensitivity.

 Do not affix, place or bind the Warmer directly to a patient during general use.
 Do not wrap the Warmer in towels, sheets, blankets or drapes.
 If the enFlow system is used for pre hospital transport or transfer to another facility

o place an insulating and cushioning fabric layer, such as soft cotton towels or gauze, at

least .25” or 6 mm thick in between the underside of the Warmer and the patient. Do not

use foam or gel pads. Cushioning the patient from the Warmer will help prevent
perioperative peripheral neuropathies.

 The Warmer heating surface and Disposable Cartridge can get quite warm when heating

cold IV fluids/blood at high flow rates. Wait a few seconds after stopping the IV fluid/blood
flow before removing the Disposable Cartridge.

 The Controller should only be plugged into a hospital grade outlet.

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 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.

 Do not clean with:

o ketones (MEK, acetone, etc.) or
o abrasive cleaners.

 Do not sterilize the Warmer with:

o steam sterilization (autoclave) or
o dry heat.

 Do not disinfect or sterilize the Controller.
 Do not spray or pour cleaning solutions directly on the Controller.
 Do not allow cleaning solutions to accumulate on the Controller.
 When using the Controller mounted to an IV pole, it must be tightly secured on the pole no

higher than 122 cm (48 in.) from the ground. The pole should have a base diameter of no less
than 61 cm (24 in.). A Controller mounted too high on the IV pole may cause instability. IV
pole accessories or the attachment of fluid bags may also cause instability.

 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.

 Always secure the infusion set with the provided IV Line Clip on the Warmer power cable to

prevent kinking in the line.

 Do not use a stiff bristle brush or sharp probe to remove foreign material.
 Do not use compressed air to dry.
 Avoid puncturing the heating surface. If damaged, remove the Warmer from service and

replace immediately.

 This equipment is not intended for use in an oxygen rich environment.
 No modification of this equipment is allowed.
 Do not position the device in a way which makes it difficult to disconnect the device.

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