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.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 6 of 26

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.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 7 of 26

 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.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 8 of 26

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. The parts list for each model is reflected below:

 Model 100

o Warmer
o Warmer Cord Clip

‡

 Model 121

o Controller
o Warmer Mount (Warmer Mount Instructions)

 Model 200

o Disposable Cartridge
o IFU

 Model 202

o Disposable Cartridge with IV Extension Set
o IFU

 All systems shipped with power cord and operators manual.

‡ Units shipped prior to 2012 may not contain the Warmer Cord Clip

To Begin Operation of the enFlow IV Fluid/Blood Warming System

a) Place the Controller on a firm, level surface or on an IV pole with an outside dimension of no

greater than 3.0 cm (1.25 in.) Two Controllers may also be mounted next to each other on an
IV pole as shown below. The Controller’s display will have a “right-side-up” orientation
regardless of its position.

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.

d) Connect the enFlow IV Fluid/Blood Warmer cable to the Controller. This action is accomplished

in three steps:

1. Insert the male plug end of the Warmer into the female

receptacle on the front face of the Controller. Push it in so that
the plug cover is tight against the receptacle.

2. The plug and receptacle are “keyed” in both orientation and

configuration. This feature ensures that the Warmer can only be
plugged in properly. Additionally, it prevents other plug devices
from fitting into this receptacle.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 9 of 26

3. Turn right to lock. (See arrows on label.)

IV Line Clip

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” occurs, and
the LED’s light up for about one (1) second.
Note The Controller automatically switches for operation at either
115 VAC or 230 VAC

f) Open the covers on the Warmer by sliding them apart.

g) Connect the infusion set and or extension set to the

Disposable Cartridge; then prime with fluid using
standard medically approved protocols. Next, connect
the infusion set to the patient and place the Disposable
Cartridge into the Warmer.

h) Completely close the covers on the Warmer by sliding

them inward toward each other until the covers meet.

Upon closing the covers, a short audible “Beep” occurs

indicating that the Warmer self-test is being performed
that confirms operation of temperature sensors and alarm
indicators. After this process is complete, regulated power

is delivered to the Warmer’s heating surface, which then

begins heating the infusate through the Disposable
Cartridge. Adjust the fluid flow to the desired rate.

i) Place the IV line in the IV Line clip in order to prevent it from kinking.

j) The Warmer is designed to be placed on the bed and/or attached to a patient coverings in

close proximity to the site of infusion using the cord clip P/N 980309VS. Cushion the patient
from the Warmer to aid in the prevention of perioperative peripheral neuropathies

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 10 of 26

k) Do not wrap the Warmer in towels, sheets, blankets or drapes.

Controller Display
Power

Keypad

Female
Receptacle
for Warmer
Connector

l) 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

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 11 of 26

Controller Display

Activity

Display Reads

Display Color and

Function

Warmer Over Temperature

Display alternates between

Over Temp and

Press Key to Mute

Identical to Warmer

Temp LED

Mute button activated.

Over Temp

Muted

Identical to Warmer

Temp LED

Fault detected

System Fault XX

If a system fault message is

on the Controller display,

contact Technical Support.

Red

High Priority Alarm

Activity

Display Reads

Display Color and

Function

While powering up the Controller,
hold the center button down until
the clock screen is displayed. Then,
use the buttons to set the clock.

09:00 A

Blue

Activity

Display Reads

Display Color and

Function

Warmer is connected and power is
engaged.

Temperature and Clock

40 °C

9:00 A

Identical to Warmer

Temp LED

Warmer is not connected, but
Controller is powered on.

Not Heating

Yellow

Warmer is connected, but covers
are open on Warmer.

Not Heating

Yellow

Warmer is connected, and covers
are either open or closed on
Warmer; however, disposable is not
in Warmer.

Not Heating

Yellow

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

Table 2: Controller Display: Alarm Mode

Table 3: Controller Display: Setup Mode

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

enFlow Warmer (Model 100 series) Indicators and Operation

Sliding Covers

Temperature Status LED

(Indicated by symbol )

Power LED

(Indicated by symbol )

Power Cable

Heating Surface

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.
Temperature - indicates that the infusate temperature is within an acceptable operating range (35

°C to 42 °C).

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 13 of 26

Table 4: Indicator Status

Status

Warmer
Covers

Disposable
Cartridge

Power
LED
Indicator

Temperature
LED
Indicator

Audible
Indicator

Description

Action Required

Ready

Open or
Closed

None

Flashing
Green
every 3
seconds

Unlit

None

Warmer unit has
power, but is not
heating

None

Power up
of device

Closed

In place

Red ½
second

Red ½
second

½ second
beep

Successful device
power up and over
temperature circuit
test

Observe. If the
LED does not flash
red, replace the
Warmer; and
contact Technical
Support.

In
Operation

Closed

In place

Solid
Green

Flashing Blue

None

Infusate
temperature is
< 33 °C.

None

In
Operation

Closed

In place

Solid
Green

Solid Blue

None

Infusate
temperature is
≥ 33 °C and < 35 °C.

None

In
Operation

Closed

In place

Solid
Green

Solid or
Flashing Blue
>30 seconds

None

Warmer is unable
to heat the infusate
within operational
range. Infusate
temperature is
< 20 °C and/or the
flow rate is > 200
mL/min.

Reduce the flow
rate if possible. If
there is no
change in
operational
temperature,
consider replacing
the Warmer and
contact Technical
Support.

In
Operation

Closed

In place

Solid
Green

Solid Green

None

Infusate
temperature is
≥ 35 °C and ≤ 42 °C.

None

In
Operation

Closed

In place

Solid
Green

Solid Yellow

None

Infusate (and/or
ambient
temperature) is >
42 °C but less than

an “Over Temp”

condition.

Observe. This
state whereby the
infusate is > 42 ºC
should only be
entered
periodically during
changes in flow
rate or infusate
temperature.

In
Operation

Closed

In place

Flashing
Red

Continuous
audible
burst

Internal failure in
the Warmer

Replace the
Warmer if this
occurs, and
contact Technical
Support.

Continuous
Operation

Closed

In place

Solid
Green

Flashing Red

High Priority
Alarm

Continuous
audible
burst

Infusate (and/or
ambient
temperature) is >
45 °C signifying an

“Over Temp”

condition.

Stop the fluid flow,
and slide the
Warmer covers
open to stop
warming. Replace
the Warmer if this
occurs, and
contact Technical
Support.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 14 of 26

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
 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.
Do not allow cleaning solutions to accumulate on the Controller.

The Warmer and Controller are chemically resistant to most common hospital grade instrument
cleaning solutions and non-caustic detergents. The following list of approved cleaning solutions may
be used to clean the Warmer and Controller:

 Isopropyl alcohol
 Mild detergent solution
 Diluted chlorine bleach (30 mL/L water)
 Ammonia based cleaners
 Glutaraldehyde-based cleaners
 Chlorhexidine

Cleaning the Warmer

Wipe down and or wash

1. After each use, clean the Warmer only as required. In many instances, it may only need to be

wiped clean.

2. If the warmer needs to be cleaned more intensively, use a cleaning solution and a soft bristle

brush to gently scrub the Warmer to remove any foreign material.

3. Rinse thoroughly with distilled water. Do not immerse the Warmer’s electrical plug

connector.

Drying

1. After cleaning, dry completely before placing back into use.

2. If disinfecting is required, dry completely before disinfecting so that the disinfecting solution

will not be diluted.

Disinfecting

1. The enFlow Warmer may be disinfected using commercially available solutions with no

greater than 2.4 % glutaraldehyde and by following the solution manufacturers’
recommendations.

2. Soak the Warmer in the disinfectant solution according to the manufacturer’s application

time guidelines. Do not immerse the Warmer’s electrical plug connector in the solution.

3. Thoroughly rinse the Warmer of all solution using distilled water.

4. Completely dry the Warmer before placing into service.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 15 of 26

5. Confirm operation. Connect the Warmer to a Controller. Insert a Disposable Cartridge into the

Warmer and close the covers. Turn the Controller to the ON position, and allow the start up
procedure to run until complete.

Cleaning the Controller

1. Use only approved cleaning solutions.

2. Moisten a clean cloth with the cleaning solution; do not spray or pour cleaning solutions

directly on to the Controller.

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)

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 16 of 26

enFlow IV Fluid/Blood Warming System Operational Checklist

Procedure Instructions

Pass
Fail

Input
Temp

Output
Temp

Inspection

Ensure that all cords and connectors are in good condition and void of any cuts, cracks, or frays.
Ensure that the units are clean and void of any cracks or other signs of damage.

Performance Test Setup

Set up the system for normal operation. Provide a 0.5 liter source of fluid at 20 °C ± 2 °C. Measure the temperature within 22.9 cm (9 in.) of
both the input and output connections of the Disposable Cartridge by inserting a T connector in the direct fluid path which will
accommodate a temperature probe. Connect the temperature probes to a meter capable of measuring between 10 °C and 60 °C with 0.1
°C accuracy. Prime the IV line setup according to standard IV protocols. Turn the enFlow system on and establish a fluid flow of 100 ± 20
mL/min. Wait for the temperature probes to stabilize.

Record the input fluid temperature. Input fluid temperature 20 °C ± 2 °C.

Record the output fluid temperature. Output fluid temperature 40 °C ± 2 °C.

Over-Temperature Alarm Check

Use performance testing setup. Change the source of fluid’s temperature to 50 °C ± 2 °C. Turn the enFlow system on and establish a fluid
flow of 100 ± 20 mL/min. Wait for the temperature at the probes to stabilize.

Record the input and output fluid temperatures.

The High Priority Over Temp Alarm occurs within less than 20 seconds of reaching input
temperature. (See Appendix C)

High Priority Alarm indicated by Audible beep and Over-Temp message in Red appearing on the
Controller.

Red Temperature LED flashes on the Warmer, Also indicating a High Priority Alarm

Electrical Safety

Follow safety analyzer manufacturer’s instructions

Test leakage current at the AC power cord using a safety analyzer.

Test leakage current of the Warmer to the saline in the IV line using a safety analyzer.

Inspected By

Enter initials and confirm date.

Comments, Observations or Corrective Actions

Warmer Serial No_________ Controller Serial No_________
Warming System Location/Identifier__________
Date:

Note Please reference the Service Manual for the specific procedures in order to perform the tests listed

above.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 17 of 26

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 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. If the unit stops working properly, contact Customer Service to obtain an RGA number
prior to returning the unit to the enFlow Service Center. If damage has occurred to the heating
surface, immediately remove it from service.

RGA Number

Prior to returning any Product, Original Purchaser must receive prior consent and must receive a
Return 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 800-932-0760
or by e-mail at [e-mail].

The Service 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. (If the Product is no longer under warranty, the Service Representative will discuss
repair/replacement options.) You will be issued a Return Goods Authorization (RGA) number. You will
be instructed to return the Product in packaging sufficient to prevent damage in transit, clearly
marking the RGA number on the outside of the box. The return address will be provided to you.

Note Federal (U.S.A.) Law requires contaminated Medical Equipment to be cleaned and disinfected
before shipment. If this is not done, your unit will be immediately returned as it is received.

Warmer (Model 100 series)

The Warmer is permanently sealed against fluid ingress and has no user serviceable parts inside.

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.

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 should be
performed at least once a year, or as required by your accrediting body.

Controller (Model 120 series)

The Controller (Product No. 980121) contains no user serviceable parts inside. Check the fuses
located in the power entry module if the Controller fails to function. The AC line power cord must be
removed to do this.

The Controller should be subjected to routine safety checks as required by local regulations, (i.e.
Earthing Impedance, Leakage Current).

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 18 of 26

Appendix A: Technical Specifications

Size

Warmer: 12.7 cm L x 6.6 cm W x 3.0 cm H, (5.0 in. L x 2.6 in.
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. W x 3.8 in. H)
Disposable Cartridge: 11.4 cm L x 3.8 cm W x 1.0 cm H, (4.5
in. L x 1.5 in. W x 0.4 in. H)
Extension Set: 120 mm L x 10.6 mm W,
(4.7 in. L x 0.4 in. W)

Weight

Warmer: (w/o Disposable): 279 g, (9.8 oz.)
Controller: 1.8 kg, (3.9 lb.)
Disposable Cartridge: 33 g (1.2 oz.)
Extension Set: 2 g (0.07 oz.)

Disposable Cartridge and (optional IV Extension Set):

Priming Volume

Disposable Cartridge: 4 mL
(optional IV Extension Set): 0.5 mL

Sterility

Gamma Sterilized

Biocompatibility

ISO 10993

Infusion Set Compatible

ISO 8536-4

Performance

Fluid Temperature Output

40 °C ± 2 °C

Flow Rate Range

KVO to 200 mL/min

Input Voltage

Warmer: 28 VDC at a maximum of 300 Watts
Controller: 110-120 or 220-240 VAC

Temperature Set Point

40 ºC

Over Temperature Set Point

ASTM F-2172-02

Alarms

IEC60601-1-8:2006

Input Current

5 A

Input Frequency Range

Warmer: DC
Controller: 47-63 Hz

Environmental/ Physical Requirements

Temperature, Operating

-5 °C to 50 °C

Temperature, Storage

-30 °C to 70 °C

Water Resistance

Warmer: IEC 529 IP67 30 minutes immersion at a depth of

91.4 cm (36 in.); Controller: IEC 529 IP21 dripping water;
Disposable Cartridge and (optional IV Extension Set): IEC
529 IP68 IV Extension Set): IEC 529 IP68 continuous
immersion

Penetration

Warmer: IEC 529 IP67 dust tight
Controller: IEC 529 IP21 ≥ 12.5 diameter (See Page 23)
Disposable Cartridge and (optional IV Extension Set): IEC

529 IP68 dust IV Extension Set): IEC 529 IP68 dust tight

Electrical Safety

UL 60601-1:2005 R6.03, CAN/CSA-C22.2 No. 60601.1:2008,
IEC 60601-1-6:2010, AAMI ES60601-1:2005, IEC 60601-1­4:2000 (Canada)

Relative Humidity, Operating and
Storage

Warmer: 10 % to 90 %
Controller: 10 % to 90 %
Disposable Cartridge and (optional
IV Extension Set): 10 % to 90 %

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 19 of 26

Altitude, Operating and Storage

up to 15,000 ft

Air Pressure, Operating and Storage

570 hPa, (17 inHg) to 1060 hPa (31 inHg)

Shock/Drop Abuse Tolerance

MIL-STD-810F

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
shock

Class I, or Internally Powered

Degree of protection against electric
shock

Type BF, Defibrillation-Proof
Mode of operation

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. The enFlow System generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause interference to other devices in
the vicinity. However, there is no guarantee that interference will not occur in a particular
installation. If the enFlow System does cause interference to other devices, which can be determined
by turning the Controller off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:

- Reposition the Warmer and any intertwined cables.

- Check ECG monitoring electrode contact and impedance.

- Confirm monitoring lead wires are functioning properly and shielding is intact.

- Connect the Controller into an outlet on a circuit different from that to which the other

device(s) are connected.

- Consult the manufacturer for help.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 20 of 26

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 – Guidance

RF Emissions
Radiated
CISPR 11

Group 1, Class B

The enFlow 100 with enFlow 120 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.

Harmonics
IEC 61000-3-2

Class A

The enFlow 100 with enFlow 120 is suitable for use in all establishments,
other than domestic, and those directly connected to the public low
voltage power supply network that supplies buildings used for domestic
purposes.

Flicker IEC 61000-3-3

Complies

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

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.

Immunity Test

EN/ IEC 60601

Test Level

Compliance Level

Electromagnetic Environment – Guidance

ESD
EN/IEC 61000-4-2

Level 3 (±6kV)
Contact

Level 3 (±8kV)
Air

Level 3 (±6kV)
Contact

Level 3 (±8kV)
Air

Floors should be wood, concrete or
ceramic tile. If floors are synthetic, the
r/h should be at least 30%
EFT
EN/IEC 61000-4-4

±2kV Mains
±1kV I/Os

±2kV Mains
±1kV I/Os

Mains power quality should be that of a
typical commercial or hospital environment.

Surge
EN/IEC 61000-4-5

±1kV Differential
±2kV Common

±1kV Differential
±2kV Common

Mains power quality should be that of a
typical commercial or hospital environment.

Voltage
Dips/Dropout
EN/IEC 61000-4-11

>95% Dip for

0.5 Cycle

60% Dip for
5 Cycles

30% Dip for
25 Cycles

>95% Dip for
5 Seconds

100% Dip for

0.5 Cycle

60% Dip for
5 Cycles

30% Dip for
25 Cycles

See Note 1

Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the enFlow
100 with enFlow 120 requires
continued operation during power mains
interruptions, it is recommended that
the enFlow 100 with enFlow 120 be
powered from an uninterruptible
power supply or battery.

Power Frequency
50/60Hz
Magnetic Field
EN/IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields
should be that of a typical commercial
or hospital environment.

Note 1) During the 5 Second event, the enFlow 100 and 120 power off, but return to normal operation as soon as
power is restored.

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.

Immunity Test

EN/IEC 60601
Test Level

Compliance
Level

Electromagnetic Environment – Guidance

Conducted RF
EN/IEC 61000­4-6

Radiated RF
EN/IEC 61000-

3 Vrms
150 kHz to 80 MHz

3 V/m
80 MHz to 2.5 GHz

3 Vrms

3 V/m

Portable and mobile communications
equipment should be separated from
the enFlow 100 with enFlow 120 by no
less than the distances calculated/listed
below:

D=(3.5/3V/m)(Sqrt P)

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 21 of 26

4-3
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).
Interference may occur in the vicinity of
equipment containing a transmitter.

Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the enFlow

The enFlow 100 with enFlow 120 is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the enFlow 100 with enFlow 120 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications
Equipment and the enFlow 100 with enFlow 120 as recommended below, according to the maximum output power
of the communications equipment.

Max Output Power

(Watts)

Separation (m)
150kHz to 80MHz
D=(3.5/V1)(Sqrt P)

Separation (m)
80 to 800MHz
D=(3.5/E1)(Sqrt P)

Separation (m) 800MHz to 2.5GHz
D=(7/E1)(Sqrt P)

0.01

.1166

0.12

0.23

0.1

.3689

.3689

.7378

1

1.1666

1.1666

2.3333

10

3.6893

3.6893

7.3786

100

11.6666

11.6666

23.3333

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 22 of 26

Controller: IEC 529 IP21 ≥ 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. Expose to 1” of rain per minute in its left IV pole orientation for 10 minutes.

5. Rotate the power supply 180 degrees to its right IV pole orientation.

6. Expose to 1” of rain per minute for 10 minutes.

7. Use the camera to record what happens while power supply is running in the rain chamber.

8. Turn “off” and remove from the rain chamber.

9. Unplug the power supply and wipe excess water away from the outside.

10. Perform validation test to confirm proper operation. Record serial numbers of test items. (TPTR_083)

11. Using a screwdriver, open the power supply. Note any moisture inside the power supply or use a camera to record its
location inside the supply.

Notes: The EDUT was placed in the Singleton Model 22 Rain Chamber.

• Opened up unit to it let dry out. The battery was also replaced. Unit is now functioning
properly. See Retest below.

Notes: Mute button and Orientation tested at end of 3 rotations to minimize water getting inside
the unit.

• Test ended at 10:56AM. Exterior of unit was dried off and then unit was tested.

• Voltage reading started out at 17.03V and started to climb. All features functioned at 20V.

Voltage stabilized at 28.06V at 11:10AM.

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 23 of 26

Appendix B: Glossary

enFlow IV Fluid/Blood
Warming System

The enFlow IV Fluid/Blood Warming System consists of three products:
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.

Warmer
(Model 100)

The Warmer is a small, lightweight, rugged fluid warmer that heats
blood, blood plasma, and intravenous fluids being delivered to the
patient’s body within seconds from 20 ºC to 40 ºC through a flow rate
range of KVO to 200 mL/min.

Controller
(Model 120)

The Controller displays a temperature readout in degrees C, as well as
containing a keypad, which controls the clock and the mute feature.
Additionally, it converts AC line power to 28 Volts DC, and is used as a
power source for the Warmer.

Disposable
Cartridge
(Model 200)

The Disposable Cartridge uses a sterile, single use component to be
used as an in-line component of an IV infusion set for the heating of
the fluids/blood being infused into the patient’s body.

Disposable
Cartridge with IV Extension

Set (Model 200)

The Disposable Cartridge with IV Extension Set product contains the
same Disposable Cartridge described above. In addition, it includes a
sterile, single use IV extension set.

Intravenous Fluids

Fluids such as Normal Saline, Dextrose, Dextron, Packed RBC’s

KVO

“Keep Vein Open” refers to an intravenous infusion rate defined as
approximately 2 mL/min (120 mL/hr).

LED

Light Emitting Diode

mL/min

Milliliters per minute

RBC’s

Packed Red Blood Cells

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 24 of 26

Fluid
Temp

Heater

Temperature LED on
Warmer

Display on Controller

Audible
Alarm

30 °C

Active

Blue Flashing

30°C Blue Flashing

No

31 °C

Active

Blue Flashing

31°C Blue Flashing

No

32 °C

Active

Blue Flashing

32°C Blue Flashing

No

33 °C

Active

Blue

33°C Blue

No

34 °C

Active

Blue

34°C Blue

No

35 °C

Active

Green

35°C Green

No

36 °C

Active

Green

36°C Green

No

37 °C

Active

Green

37°C Green

No
38 °C

Active

Green

38°C Green

No

39°C

Active

Green

39°C Green

No

40 °C

Active

Green

40°C Green

No

41 °C

Off

Green

41°C Green

No

42 °C

Off

Green

42°C Green

No

43 °C

Off

Yellow

43°C Yellow

No

44 °C

Off

Yellow

44°C Yellow

No

45 °C

Off

Red Flashing High Priority
Alarm after 20 seconds

45°C after 20 seconds
Red Flashing "Over
Temp" message

After 20
seconds

46 °C

Off

Red Flashing High Priority
Alarm after 16 seconds

46°C after 16 seconds
Red Flashing "Over
Temp" message

After 16
seconds

47 °C

Off

Red Flashing High Priority
Alarm after 12 seconds

47°C after 12 seconds
Red Flashing "Over
Temp" message

After 12
seconds

48 °C

Off

Red Flashing High Priority
Alarm after 8 seconds

48°C after 8 seconds
Red Flashing "Over
Temp" message

After 8
seconds

49 °C

Off

Red Flashing High Priority
Alarm after 4 seconds

49°C after 4 seconds
Red Flashing "Over
Temp" message

After 4
seconds

50 °C

Off

Red Flashing High Priority
Alarm (immediately)

Red Flashing "Over
Temp" message
(immediately)

Immediately

Appendix C: Warming System Response by Temperature

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12 Page 25 of 26

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

Power Cord USA

Appendix D: Parts List

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