GE Vital Signs enFlow User manual

enFlow*
IV Fluid / Blood Warming System
Service Manual

4400_0060 enFlow Service Manual Rev. F 04/12 Page 2 of 36
About this Manual
This Service Manual has been developed to provide authorized agents of Vital Signs Inc., with the necessary information
to service the enFlow IV Fluid/Blood Warming System. It is important that all such agents responsible for servicing this
device read and understand all the information contained within this Service Manual. Please note an Operator’s Manual
is also available.
WARNING:
This Service Manual is available in English only.
If a customer’s service provider requires a language other than English, it is the customer’s responsibility to provide
translation services.
Do not attempt to service the equipment unless this Service Manual has been consulted and is understood.
Failure to heed this Warning may result in injury to the service provider, operator or patient from electric shock,
mechanical or other hazards.
If you have questions or concerns regarding these manuals or product, please contact one of the following for
assistance:
Customer Service
Phone: [phone]m, option 1
Email: vitalsignscustom[email protected]
Technical Support
Phone: [phone]
Service Center Address
Vital Signs, Inc.
a GE Healthcare Company
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_0060 enFlow Service Manual Rev. F 04/12 Page 3 of 36
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
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 60601-1-
4:2000.
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.

4400_0060 enFlow Service Manual Rev. F 04/12 Page 4 of 36
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).
Not Heating
Heating, Normal Operation
Alarm Muted (for an intermittent time
period)
Press Any Key to Mute Alarm.
System Fault XX
Authorized Representative in the European Community
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/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.

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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 ....... 11
WARMER (MODEL 100 SERIES)........................................................................................... 11
CONTROLLER/AC POWER PACK (MODEL 120 SERIES) - SETUP INSTRUCTIONS ....... 12
CONTROLLER/AC POWER PACK (MODEL 120 SERIES) AND AC POWER PACK (MODEL
120 SERIES)............................................................................................................................ 12
ENFLOW FLUID WARMING SYSTEM TEMPERATURE CONTROL AND ALARMS........... 15
ENFLOW TROUBLESHOOTING ........................................................................................... 16
APPENDIX A: TECHNICAL SPECIFICATIONS ..................................................................... 18
APPENDIX B: WARMER FAULT CODE TABLE .................................................................... 24
APPENDIX C: GLOSSARY...................................................................................................... 25
APPENDIX D: WARMING SYSTEM RESPONSE BY TEMPERATURE................................. 26
APPENDIX E: PARTS LIST .................................................................................................... 26
APPENDIX F: PREVENTIVE MAINTENANCE RECORD ..................................................... 26

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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.
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 only distinction between the two versions of the Warmer, both of which are Model 100 series, is the
connector at the end of the power cord, which determines whether the unit will powered from alternating or
direct current.
Model 100
Hubbell Connector
Multi-Purpose Military Hubbell
Connector (MMHC)
Alternating Current
/
Alternating Current / or
Direct Current
The Controller/AC Power Pack serves as a power supply for the Warmer
unit. The Controller/AC Power Pack is designed to mount on an IV pole or
sit on a table top. The front panel includes a temperature display
reading in degrees C, as well as a keypad, which controls the clock and
the mute feature. Regardless of the orientation of the unit, the
temperature readout is always displayed in a “right-side-up”view.
The AC Power Pack also serves as a power source for the Warmer unit. It is
similar in design to the Controller/AC Power Pack only without the display
feature.

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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.
The Disposable Cartridge connects to the enFlow IV Extension Set or any infusion set employing
standard luer connectors. Once primed, the Disposable Cartridge in conjunction with the Warmer and the
Controller/AC Power Pack 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. This device may also help make patients more comfortable during IV infusions.

4400_0060 enFlow Service Manual Rev. F 04/12 Page 8 of 36
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®part # GDB 5A or equivalent. Bussmann® is 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.
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
oplace 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.
oThe 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.
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/AC Power Pack should only be plugged into a hospital grade outlet.
Do not block the fan in the Controller/AC Power Pack as this may cause overheating.

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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:
oketones (MEK, acetone, etc.) or
oabrasive cleaners.
Do not sterilize the Warmer with:
osteam sterilization (autoclave) or
odry 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/AC Power Pack 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/AC Power Pack 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 clip provided 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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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/AC Power Pack 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.
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.
5. Confirm operation. Connect the Warmer to a Controller. Insert a Disposable Cartridge into the
Warmer and close the covers. Turn the Controller/AC Power Pack to the ON position, and allow the
start up procedure to run until complete.
Cleaning the Controller/AC Power Pack or AC Power Pack
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.

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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/AC Power Pack 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/AC Power Pack should be stored in a clean, dust free environment. (See
Appendix A)
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 Inc., 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 (+1 973.956.5431) or by e-mail
at vitalsignscust[email protected].
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.
(If the Product is no longer under warranty, the Technical Support 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.
Replaceable parts Warmer:
IV line clip
Covers
Warmer cord clip
To order replacement parts, please reference the Recommended Supply List for specific product numbers.

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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.
Controller/AC Power Pack (Model 120 series) - Setup Instructions
1. Set the clock
a. To modify the initial default mode of the Controller, press any of the front keys of the display
window prior to pushing the power switch that is located in the back of the unit. The key must
be held down continuously until the clock is displayed.
b. Once the clock appears, toggle the center button to move through the fields. To change a
field, press the right or left arrow keys.
2. Set the Controller/AC Power Pack display default mode to symbols
a. Continue to toggle through to the set zone field. Press either the right or left arrow key to
access the padlock symbol to enter the password screen.
b. An underscore will display under the first digit field. Press the arrow key to set the appropriate
digit.
c. Next, press the center key again to toggle to the next place.
d. Repeat steps three and four for the second and third digits. If an incorrect password is
entered, the system reverts to the set zone screen.
e. After the third digit is set, press the center key again. First a green padlock and then the zone
USA will appear. Press the right arrow to change to INTL.
f. Press the center key again to set. The system begins to operate.
g. After the initial setup, whenever the Controller/AC Power Pack is powered on the display
screen defaults to the last mode entered.
h. The password is 781.
Controller/AC Power Pack (Model 120 series) and AC Power Pack (Model 120
series)
The enFlow Controller/AC Power Pack (Model 120 series) and AC Power Pack (Model 120 series) contains
some parts that may be replaced. Check the fuses located in the power entry module if the Controller/AC
Power Pack or AC Power Pack fails to function. The AC line power cord must be removed to do this.
Replaceable parts Controller/AC Power Pack and AC Power Pack:
Clock battery (See below for instructions on how to
replace.)
Fuse - Bussmann #GDB 5A or equivalent (See below
for instructions on how to replace.)
Cover (Bottom Only)
Screws
Pole clamp screw
Power cord
Warmer Mount
To order replacement parts, please reference the Recommended Supply List for specific product numbers.
For information on safety checks, please see Appendix F: Preventive Maintenance Procedure.

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Instructions for replacing the Controller/AC Power Pack clock battery.
1. Turn Controller/AC Power Pack over.
2. To remove the bottom, unscrew Pole Clamp screw; unscrew 4 screws shown below. Next, lift the cover.
3. Power Assembly
a. On the power supply assembly, unscrew 2 screws shown below (see Diagram 5).
b. Gently lift up assembly by holding pole clamp, and prop up with a small block or box (see
Diagram 6).
Diagram 1
Diagram 2
Diagram 4
Diagram 5
Diagram 6
Diagram 3

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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. Pull the display panel away from the fan assembly.
d. Take a pair of pliers and gently pull out battery.
e. Insert new battery. Push firmly into place.
f. Reinsert and tighten all screws on the display board
5. Reassembly
a) Reseat fan assembly and display board (see Diagram 5).
b) When reseating display board, make sure that all wires are between the two white posts (see
Diagram 6).
c) When reseating the fan assembly on the display board end, make sure that the wires are inside
the corner post_1 (see Diagram 5) and wrap around the edge of the fan assembly.
d) On the opposite end from the display board, make sure the wires go around the outside of the
corner post_2 (see Diagram 5).
e) Reinsert and tighten the 2 screws for the power assembly (see Diagram 5).
f) Attach bottom cover; reinsert and tighten the six related cover screws (see Diagram 3).
g) Reinsert pole clamp screw.
h) Dispose of the old battery in accordance with any government regulations in affect in your area.
Diagram 7

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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.
2. Pull the broken fuse out of the case.
3. Replace the fuse with (Bussmann #GDB 5A or equivalent). When reinserting the fuse case into the socket
on the Controller, it is keyed so that it can only be inserted in the correct orientation. Push the case in
gently, but firmly, until it snaps into place. At this point, it will be flush with the surrounding surface.
enFlow Fluid Warming System Temperature Control and Alarms
Temperature Control
The enFlow IV Fluid/Blood Warming System includes multiple safety features to prevent over-heating 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. Closed-loop temperature control software
2. Audible and visual alarms
3. Software system monitor
4. Independent heater temperature monitoring circuit
Audible / Visual Alarms
The enFlow Warmer incorporates an audible/visual alarm system. This system monitors the fluid
temperature for an over-temperature condition and system faults. The alarm function is tested each time a
Cartridge is inserted. The audible alarm is briefly sounded, and the red light emitting diode indicator is also
briefly illuminated. If a dangerous condition occurs, a continuous audible and visual alarm is activated.
When used with the Model 121 Controller, the audible alarm will come from the Controller, and the display
will identify the alarm condition. When the Warmer is used with Model 120 power supply, the temperature
LED will flash and the audible alarm will come from the Warmer. Over-temperature conditions are
calculated according to ASTM Standard F2172-02 (an FDA Recognized Standard for fluid warmers). This
standard allows for spikes in the fluid temperature without activating an alarm. The alarm has a linear time-
temperature relationship, therefore, the hotter the fluid the less time it will take for the alarm to be activated.
At 45 ºC the alarm will sound after about 20 seconds while at 50 ºC it will be essentially instantaneous. The
alarm will be activated by either the Warmer over-heating the fluid or if the fluid entering the Warmer is too
hot. The audible aspect of the alarm can be muted for 1 minute by pressing any key on the Controller. The
alarm can also be ended completely by sliding open the covers on the Warmer. (For further information,
please reference test for Over-temperature Alarm located in Appendix F: Preventive Maintenance Procedure.
Fusecase
Fuses

4400_0060 enFlow Service Manual Rev. F 04/12 Page 16 of 36
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.
There are published suggestions to reduce or eliminate the interference which should be employed.
“Interference of the monitored or recorded electrocardiogram is common within operating room and intensive care unit
environments.”
1
The enFlow®IV Fluid / Blood Warmer System as with all electrical devices can be associated
with some electromagnetic interference (EMI), however, it has been uncommon and inconsistently
experienced, even within accounts reporting the issue.
On previous occasions when interference has been reported, we have frequently been successful in
resolving the issue using common troubleshooting suggestions. Please review each and be prepared to
implement them should an account voice a concern.
Interference Confirmation
Turn the unit off.
Turn the power supply on the back of the Controller/AC Power Pack to the OFF position. Reassess the
inference. Knowing that cardiac or neuro monitoring is being affected determine if the interference adversely
affects your ability to care for the patient. Consider attempting to reduce the level of interference by
employing some simple and readily available solutions.
Interference Reductions
Check the monitoring pads
All monitoring pads should be full adhered to the patient’s properly prepared skin. Please confirm that the
pad’s foam insulator is not curled up, peeled back or otherwise exposing the conductive gel layer. Confirm
that the leadwires’ connectors are properly and fully attached. Consider reapplying monitoring electrodes if
there is any suspicion they have become dried out
Confirm the patient is properly grounded.
In many cases, and in all cases using mono-polar or bi-phase cautery a grounding pad should present and
applied according to the manufacturers instructions. As previously suggested confirm the ground pad is fully
adhered to a properly prepared skin surface.
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 and it is getting expressed on the monitor. Secondly, it is possible that the outlets are not properly
grounded or grounded in different locations. While rare it can be the case and outwardly there would be no
way to tell not even on most other equipment in use.
Confirm the warmer cord is not entwined or near the ECG lead cable.
Separating the two cords will allow each ones shielding to work to its full potential.
Confirm the monitoring cables and lead wires are in proper working order
The insulating layer on lead wires and cables degrades over time and with use. Please confirm that the
insulation is intact and operates at its stated specifications.
Review the monitor’s notch filter.
Check to ensure that the monitoring systems frequency filter is set appropriately.
Determine the monitor’s sensitivity setting.
Many physiological monitors have the ability to interpret electrical signals in two distinct modes: a highly
1
Patel, Santosh I. M.D., F.R.C.A. and . Souter, Michael J, M.B., Ch.B., F.R.C.A.; Equipment-related Electrocardiographic Artifacts,
Causes, Characteristics, Consequences, and Correction; Anesthesiology 2008; 108:138–48.

4400_0060 enFlow Service Manual Rev. F 04/12 Page 17 of 36
sensitive ‘Diagnostic” mode or a more filtered “Monitoring” mode. Determine the current mode of operation.
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.

4400_0060 enFlow Service Manual Rev. F 04/12 Page 18 of 36
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 IPX7 30 minutes immersion at a depth of
91.4 cm (36 in.); Controller: IEC 529 IPX1 dripping water;
Disposable Cartridge and (optional IV Extension Set): IEC
529 IPX8 IV Extension Set): IEC 529 IPX8 continuous
immersion
Penetration
Warmer: IEC 529 IP6X dust tight
Controller: IEC 529 IP2X ≥ 12.5 diameter
Disposable Cartridge and (optional IV Extension Set): IEC
529 IP6X dust IV Extension Set): IEC 529 IP6X 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 60601-1-
4:2000 (Canada)
Relative Humidity, Operating and
Storage
Warmer: 10 % to 90 %
Controller: 10 % to 90 %
Disposable Cartridge and (optional
IV Extension Set): 10 % to 90 %
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

4400_0060 enFlow Service Manual Rev. F 04/12 Page 19 of 36
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/AC Power Pack 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/AC Power Pack into an outlet on a circuit different from that to which the
other device(s) are connected.
-Consult the manufacturer for help.
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
Clock Battery Specifications
Cell #....................................................... CR2032
Classification…………………………………. Lithium Coin
Chemical System…………………………… Lithium / Manganese Dioxide (Li/MnO2)
Designation…………………………………….. ANSI / NEDA-5004LC, IEC-CR2032
Nominal Voltage……………………………. 3.0 Volts
Typical Capacity…………………………….. 220 mAh
enErgy Battery Specifications
Voltage……………………………………………….. 28VDC
Capacity……………………………………………… 3 A hrs.
Chemistry……………………………………………. Li-ion

4400_0060 enFlow Service Manual Rev. F 04/12 Page 20 of 36
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 61000-
4-6
Radiated RF
EN/IEC 61000-
4-3
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)
D=(3.5/3V/m)(Sqrt P)
80 to 800 MHz