Defibtech Lifeline/ReviveR DDU-100 User manual

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Defibtech DDU-100
Semi-Automatic
External Defibrillator
User Manual
AHA /ERC 2010
ELECTRONIC
DISTRIBUTION
www.AmericanAED.com

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Notices
Defibtech shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use of
this material.
Information in this document is subject to change without notice. Names and data
used in the examples are fictitious unless otherwise noted.
Limited Warranty
The “Limited Warranty” shipped with Defibtech AED products serves as the sole
and exclusive warranty provided by Defibtech, LLC with respect to the products
contained herein.
Copyright
Copyright © 2014 Defibtech, LLC.
All rights reserved. Copyright questions should be directed to Defibtech.
For contact information, refer to the “Contacts” section of this manual.
Tracking
U.S.A. federal regulations require Defibtech to maintain records for each AED it
distributes (reference 21 CFR 821, Medical Device Tracking). These requirements
also apply anytime there is a change in the AED’s location, including if you move,
sell, donate, give away, export or even throw it away. We depend on AED owners/
users/holders to contact us when these things happen to ensure the tracking
information remains accurate in the event we need to share important product
notices. If your location is outside the U.S.A., we ask you share your information
for exactly the same reasons. To keep your information up to date, please inform
Defibtech using the information in the “Contacts” section contained in this
document.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Contents
1 Introduction to the DDU-100 Series AED .....................................................1
1.1 Overview .................................................................................................................. 1
1.2 The Defibtech DDU-100 AED................................................................................... 2
1.3 Indications................................................................................................................ 4
1.4 Contraindications .................................................................................................... 4
1.5 Operator Training Requirements ............................................................................ 4
2 Dangers, Warnings and Cautions..................................................................5
2.1 Shock, Fire Hazard, Explosion................................................................................ 5
2.1.1 Electricity............................................................................................................ 5
2.1.2 Battery Pack........................................................................................................ 5
2.1.3 Usage Environment........................................................................................... 6
2.1.4 Defibrillation/Shock Delivery ............................................................................ 6
2.1.5 Maintenance ...................................................................................................... 7
2.2 Improper Device Performance................................................................................ 7
2.2.1 Usage Environment........................................................................................... 7
2.2.2 Pads .................................................................................................................... 8
2.2.3 Patient Analysis.................................................................................................. 8
2.2.4 Shock Delivery ................................................................................................... 9
2.2.5 Maintenance ...................................................................................................... 9
2.3 General ................................................................................................................... 10
3 Setting up the DDU-100 AED......................................................................11
3.1 Overview ................................................................................................................ 11
3.2 Installing the Data Card ........................................................................................12
3.3 Installing the Active Status Indicator 9V Battery ...............................................12
3.4 Installing and Removing the Battery Pack ..........................................................13
3.5 Connecting the Pads .............................................................................................14
3.6 Performing Manually Initiated Self-Tests ............................................................15
3.7 Storing the DDU-100 AED .....................................................................................15
4 Using the DDU-100 AED .............................................................................17
4.1 Overview ................................................................................................................17
4.2 Checking DDU-100 AED Status ............................................................................18
4.3 Turning on the DDU-100 AED................................................................................18

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4.4 Preparation............................................................................................................. 19
4.4.1 Call for Help ..................................................................................................... 19
4.4.2 Preparing the Patient....................................................................................... 19
4.4.3 Opening the Pad Package ............................................................................... 19
4.4.4 Connecting Defibrillation Pads to the DDU-100 AED.................................... 19
4.4.5 Applying Pads to the Patient...........................................................................20
4.4.6 Follow DDU-100 AED Prompts .......................................................................21
4.5 Heart Rhythm Analysis .........................................................................................22
4.6 Delivering the Shock .............................................................................................23
4.7 No Shock Required................................................................................................25
4.8 Post-Shock CPR .....................................................................................................26
4.9 Post Use Procedures .............................................................................................27
4.10 Operational Environment .....................................................................................27
5 Maintaining and Troubleshooting the DDU-100 AED ..................................29
5.1 Self-Tests................................................................................................................29
5.2 Routine Maintenance............................................................................................30
5.2.1 Checking Active Status Indicator....................................................................30
5.2.2 Checking the Condition of the Unit and Accessories....................................31
5.2.3 Running a Manually Initiated Self-Test..........................................................32
5.2.4 Replacing Pads ................................................................................................32
5.2.5 Checking Pad and Battery Pack Expiration Dates..........................................33
5.2.6 Checking the DDC If One Was Installed..........................................................33
5.3 Replacing the Lithium 9V ASI Battery .................................................................34
5.4 Cleaning .................................................................................................................35
5.5 Storage ...................................................................................................................35
5.6 Operator’s Checklist..............................................................................................36
5.7 Troubleshooting.....................................................................................................37
5.8 Repair .....................................................................................................................39
6 DDU-100 AED Accessories .........................................................................41
6.1 Defibrillation/Monitoring Pads.............................................................................41
6.2 Battery Packs .........................................................................................................41
6.2.1 Battery Pack Active Status Indicator...............................................................42
6.2.2 Active Status Indicator Battery.......................................................................42
6.3 Data Cards..............................................................................................................42
6.4 Recycling Information ...........................................................................................43
6.4.1 Recycling Assistance .......................................................................................43
6.4.2 Preparation.......................................................................................................43
6.4.3 Packaging .........................................................................................................43
6.4.4 Notice to European Union Customers ..........................................................44

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7 Event Viewing .............................................................................................45
7.1 Defibtech Data Cards ............................................................................................45
7.2 Downloading the Internal Data Log.....................................................................46
8 Technical Specifications .............................................................................47
8.1 Defibtech DDU-100 AED ........................................................................................47
8.1.1 Physical.............................................................................................................47
8.1.2 Environmental..................................................................................................47
8.1.3 Defibrillator ......................................................................................................48
8.1.4 Waveform Specifications ................................................................................48
8.1.5 Patient Analysis System..................................................................................49
8.1.5.1 Shockable Rhythm Criteria ......................................................................50
8.1.5.2 Patient Analysis System Performance.....................................................51
8.1.6 Clinical Summary ............................................................................................51
8.1.6.1 Background..............................................................................................51
8.1.6.2 Methods..................................................................................................52
8.1.6.3 Results ....................................................................................................52
8.1.6.4 Conclusion ..............................................................................................52
8.1.7. Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions and Immunity....................................................53
8.2 Battery Packs .........................................................................................................56
8.2.1 High-Capacity Lithium Battery Pack ...............................................................56
8.2.2 Standard Lithium Battery Pack .......................................................................56
8.3 Self-Adhesive Defibrillation/Monitoring Pads ....................................................57
8.4 Defibtech Data Cards (DDCs)................................................................................57
8.5 DefibView...............................................................................................................58
9 Glossary of Symbols...................................................................................59
10 Contacts ....................................................................................................63
11 Warranty Information.................................................................................65

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1 Introduction to the DDU-100 Series AED
This User Manual provides information to guide trained operators in the use and maintenance of the
Defibtech DDU-100 series Semi-Automatic External Defibrillator (“AED”) and its accessories. This
chapter includes an overview of the AED, a discussion of when it should and should not be used, and
information on required operator training.
1.1 Overview
The DDU-100 AED is a Semi-Automatic External Defibrillator (“AED”) that is designed to be easy to
use, portable and battery powered. It has only two user controls: the ON/OFF and SHOCK buttons.
Voice prompts and visual indicators provide a simple interface for the operator. The DDU-100 AED is
capable of recording event information including ECG, audio data (optional), and SHOCK/NO-SHOCK
recommendations.
When connected to a patient who is unconscious and not breathing, the DDU-100 AED performs the
following tasks:
• Prompts the operator to take necessary actions to enable analysis.
• Automatically analyzes the patient’s ECG.
• Determines whether a shockable rhythm is present.
• Charges the defibrillation capacitor and arms the SHOCK button if the AED
detects a shockable rhythm.
• Prompts the operator to press the SHOCK button when the device is ready and a shock is
recommended.
• Delivers a shock once the device has determined a shock is required and the SHOCK button has
been pressed.
• Repeats the process if additional shocks are required.
The Defibtech DDU-100 AED will NOT shock a patient automatically; it will only advise the operator.
The SHOCK button is enabled only when a shockable rhythm is detected and the device is charged
and ready to shock. Charging occurs automatically when the device detects a shockable rhythm. The
operator must press the SHOCK button to initiate defibrillation.
The DDU-100 AED uses two self-adhesive defibrillation/monitoring pads to monitor ECG signals and,
if necessary, to deliver defibrillation energy to the patient. These pads (also known as electrodes) are
provided in a single-use, disposable package.
The DDU-100 AED determines proper pad-to-patient contact by monitoring the impedance between
the two pads (impedance varies with the electrical resistance of the patient’s body). Visual and audio
prompts inform the operator of possible problems with patient contact. Voice prompts and visual
indicators communicate the status of the AED and of the patient to the operator. The DDU-100 AED
has two push-button controls and several LED indicators.

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Defibrillation energy is delivered as an impedance compensated biphasic truncated exponential
waveform. The device delivers 150 Joules into a 50-ohm load when using adult pads or when
using attenuated child / infant pads, 50J of defibrillation energy into a 50-ohm load. Energy
delivered does not change significantly with patient impedance, although the duration of the
generated waveform will vary. The Defibtech AED is designed to deliver up to 150J of defibrillation
energy through a patient impedance range of 25 – 180 ohms or 50J of defibrillation energy when
using the child / infant pads.
Defibrillation and AED operating power is supplied by a replaceable (non-rechargeable) lithium
battery pack that provides for long standby life and low maintenance operation. Battery packs are
available in several configurations optimized for use in specific applications. Each pack is marked
with an expiration date.
The DDU-100 AED records event documentation internally and, optionally, on Defibtech Data Cards
(“DDC”). The optional DDC plugs into a slot in the AED and enables the AED to record event
documentation, and audio (audio enabled cards only) if sufficient space is available on the card.
Audio recording is available only for units with installed audio-enabled Defibtech Data Cards. Event
documentation stored internally can be downloaded onto a DDC for review.
1.2 The Defibtech DDU-100 AED
A. Speaker. The speaker projects the voice prompts when the DDU-100 AED is on. The
speaker also emits a “beep” when the unit is in standby mode and has detected a condition
that requires operator attention.
B. SHOCK button. This button will flash when a shock is recommended - push this button to
deliver the shock to the patient. This button is disabled at all other times.
C. “analyzing” LED (Light Emitting Diode). This green LED flashes when the DDU-100 AED is
analyzing the patient’s ECG rhythm.
D. “do not touch patient” LED. This red LED flashes when the DDU-100 AED detects motion
or other interference that prevents analysis of the signal or when the user should not be
touching or moving the patient.
E. “check pads” LED. This red LED flashes when the DDU-100 AED detects that the pad
connection to the patient is poor or pads are not applied.
F. ON/OFF button. Push button to turn the DDU-100 AED on. Push again to disarm and turn
the AED off.
G. Pads connector port. Insert Patient Pads Connector (item O) into this port to connect pads
to DDU-100 AED.

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H. Battery pack. The battery pack provides a replaceable main power source for the DDU-100 AED.
I. Battery pack opening. Insert the battery pack firmly into this opening until the latch clicks
into place.
J. Battery pack eject button. This button releases the battery pack from the DDU-100 AED. To
remove the battery pack, push the button until the battery pack is partially ejected from the unit.
K. Active Status Indicator (ASI). When the unit is off, this indicator blinks green to indicate the
unit is fully operational and blinks red to indicate unit needs attention from the user or servicing.
L. Patient pads. The defibrillation/monitoring pads that are placed on the patient. The pads
may be stored in the pad storage area on the back of the unit.
M. Defibtech Data Card (DDC). This optional plug-in card provides enhanced storage
capabilities to the DDU-100 AED.
N. Active Status Indicator (ASI) battery. This is a 9V lithium battery that provides power to
the Active Status Indicator. It is inserted into a compartment in the battery pack.
O. Patient pads connector. Insert into Pads Connector Port (item G) to connect pads to the
DDU-100 AED.
G
F
E
D
C
B
A
KL
M
J
N
H
I
O

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1.3 Indications
The DDU-100 AED is indicated for use on victims of sudden cardiac arrest (“SCA”) when the
patient is:
• Unconscious and unresponsive.
• Not breathing.
For patients under 8 years old, use child/ infant electrode pads. Do not delay therapy
to determine exact age or weight.
The DDU-100 AED must be used by or on the order of a physician.
1.4 Contraindications
The DDU-100 AED should not be used if the patient shows any of the following signs:
• Conscious and/or responsive.
• Breathing.
• Has a detectable pulse.
1.5 Operator Training Requirements
In order to safely and effectively operate the DDU-100 AED, a person shall have met the following
requirements:
• Defibtech DDU-100 AED and/or defibrillation training as required by local, state, provincial,
or national regulations.
• Any additional training as required by the authorizing physician.
• Thorough knowledge and understanding of the material presented in this User Manual.

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2 Dangers, Warnings and Cautions
This chapter includes a list of danger, warning, and caution messages that relate to the Defibtech
DDU-100 AED and its accessories. Many of these messages are repeated elsewhere in this
User Manual and on the DDU-100 AED or accessories. The entire list is presented here for
convenience.
DANGER: Immediate hazards that will result in serious personal injury
or death.
WARNING: Conditions, hazards, or unsafe practices that may result in
serious personal injury or death.
CAUTION: Conditions, hazards, or unsafe practices that may result in
minor personal injury, damage to the DDU-100 AED, or loss
of data.
2.1 Shock, Fire Hazard, Explosion
2.1.1 Electricity

DANGER
Hazardous electrical output. This equipment is for use only by qualified
personnel.
2.1.2 Battery Pack

CAUTION
Follow all battery pack labeling instructions. Do not install battery packs after
the expiration date.

WARNING
Lithium battery packs are not rechargeable. Any attempt to recharge a lithium
battery pack may result in fire or explosion.

WARNING
Do not immerse battery pack in water or other liquids. Immersion in fluids may
result in fire or explosion.

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
WARNING
Do not attempt to recharge, short-circuit, puncture, or deform battery. Do not
expose battery to temperatures above 50°C (122°F). Remove battery when
depleted.

CAUTION
Recycle or dispose of lithium battery packs in accordance with local, state,
provincial, and/or national regulations. To avoid fire and explosion hazard, do not
burn or incinerate the battery.
2.1.3 Usage Environment

DANGER
Possible fire or explosion. Do not use in the presence of flammable gases
or anesthetics. Use care when operating this device close to oxygen sources
(such as bag-valve-mask devices or ventilator tubing). Turn off gas source or
move source away from patient during defibrillation, if necessary.

DANGER
The DDU-100 AED has not been evaluated or approved for use in hazardous
locations as defined in the National Electric Code standard. In compliance
with IEC classification the DDU-100 AED is not to be used in the presence of
flammable substance/air mixtures.

CAUTION
Do not immerse any portion of this product in water or other fluids. Do not
allow fluids to enter the device. Avoid spilling any fluids on this device or
accessories. Spilling fluids into the DDU-100 AED may damage it or present a
fire or shock hazard. Do not autoclave or gas sterilize the DDU-100 AED or its
accessories.

CAUTION
The DDU-100 AED should be stored and used only within the range of
environmental conditions specified in the technical specifications.
2.1.4 Defibrillation/Shock Delivery

WARNING
Defibrillation current can cause operator or bystander injury. Do not touch the
patient during defibrillation. Do not touch equipment connected to the patient
or metal objects in contact with the patient during defibrillation. Disconnect
other electrical equipment from the patient before defibrillating. Disconnect
the DDU-100 AED from the patient prior to use of other defibrillators.

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
WARNING
Improper use can cause injury. Use the DDU-100 AED only as instructed in the
User Manual. The DDU-100 AED delivers electrical energy that can potentially
cause death or injury if it is used or discharged improperly. Do not discharge
with defibrillation pads touching or gel surface exposed.

WARNING
Disconnect all non-defibrillator proof equipment from the patient before
defibrillation to prevent electrical shock hazard and potential damage to that
equipment.

CAUTION
Avoid contact between parts of the patient’s body and conductive fluids such
as water, gel, blood or saline, and metal objects, which may provide unwanted
pathways for defibrillating current.
2.1.5 Maintenance

WARNING
Electrical shock hazard. Dangerous high voltages and currents are present.
Do not open unit, remove covers, or attempt repair. There are no user
serviceable components in the DDU-100 AED. Refer servicing to qualified
service personnel.
2.2 Improper Device Performance
2.2.1 Usage Environment

WARNING
Radio frequency (RF) interference from RF devices such as cellular phones and
two-way radios can cause improper AED operation. In accordance with IEC
801.3, a distance of 2 meters (6 feet) between RF devices and the DDU-100
AED is recommended.

CAUTION
Although the DDU-100 AED is designed for a wide variety of field use
conditions, rough handling beyond specifications can result in damage to the
unit.

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2.2.2 Pads

WARNING
Use only Defibtech disposable self-adhesive defibrillation/monitoring pads,
battery packs, and other accessories supplied by Defibtech or its authorized
distributors. Substitution of non-Defibtech approved accessories may cause
the device to perform improperly.

CAUTION
Follow all defibrillation pad label instructions. Use defibrillation pads prior to
their expiration date. Do not re-use defibrillation pads. Discard defibrillation
pads after use (in the event of suspected pad malfunction, return pads to
Defibtech for testing).

WARNING
The defibrillation pads are intended for one time use only and must be
discarded after use. Reuse can lead to potential cross infection, improper
performance of the device, inadequate delivery of therapy and/or injury to the
patient or operator.
2.2.3 Patient Analysis

WARNING
Aggressive or prolonged CPR to a patient with defibrillation pads attached can
cause damage to the pads. Replace the defibrillation pads if they become
damaged during use.

WARNING
CPR during analysis can cause incorrect or delayed diagnosis by the patient
analysis system.

WARNING
Do not place adult defibrillation pads in the anterior-posterior (front-back)
position. A shock or no shock decision may be inappropriately advised. The
DDU-100 AED requires that the adult defibrillation pads be placed in the
anterior-anterior (front-front) position.

WARNING
Some very low amplitude or low frequency rhythms may not be interpreted
as shockable VF rhythms. Also some VT rhythms may not be interpreted as
shockable rhythms.

WARNING
Handling or transporting the patient during ECG analysis can cause incorrect or
delayed diagnosis, especially if very low amplitude or low frequency rhythms
are present. During analysis and from “Shock Advised” until “Shock Delivered,”
patient movement and vibration must be minimized.

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
WARNING
In patients with cardiac pacemakers, the DDU-100 AED may have reduced
sensitivity and not detect all shockable rhythms. If you know the patient has
an implanted pacemaker, do not place electrodes directly over an implanted
device.
2.2.4 Shock Delivery

WARNING
Do not allow defibrillation pads to touch each other, or to touch other ECG
electrodes, lead wires, dressings, transdermal patches, etc. Such contact can
cause electrical arcing and patient skin burns during defibrillation and may divert
defibrillating energy away from the heart.

WARNING
During defibrillation, air pockets between the skin and defibrillation pads can
cause patient skin burns. To help prevent air pockets, make sure self-adhesive
defibrillation pads completely adhere to the skin. Do not use dried out or
expired defibrillation pads.
2.2.5 Maintenance

WARNING
Periodic user-initiated and automatic self-tests are designed to assess the
DDU-100 AED’s readiness for use. However, no degree of testing can assure
performance or detect abuse, damage, or a defect that occurred after the most
recent test is completed.

WARNING
Use of damaged equipment or accessories may cause the device to perform
improperly and/or result in injury to the patient or operator.

CAUTION
Improper maintenance can cause the DDU-100 AED not to function. Maintain
the DDU-100 AED only as described in this User Manual. The AED contains
no user serviceable parts – do not take the unit apart.

WARNING
No modification of this equipment is allowed.

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2.3 General

CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.

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3 Setting up the DDU-100 AED
This chapter describes the steps required to make your Defibtech DDU-100 AED operational. The
DDU-100 AED is designed to be stored in a “ready” state. This chapter tells you how to make the
device ready, so that if and when you need it, few steps are required to begin using the device.
3.1 Overview
The following components and accessories are included with your DDU-100 AED. Replacement
and other accessories are detailed in the “DDU-100 AED Accessories” section. Before getting
started, identify each component and ensure that your package is complete.
• DDU-100 AED • Battery pack
• 9V lithium battery
• Defibtech Data
Card (DDC)
(optional)
• Defibrillation pad
package • User Manual
Defibtech DDU-100
Semi-Automatic
External Defibrillator
User Manual

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3.2 Installing the Data Card
The Defibtech Data Card (“DDC”) is used to store event and audio
information collected by the AED. All DDU-100 AEDs will operate
without DDCs and will still store critical event information internally.
Different DDC versions store different amounts of information. DDCs
are available in versions that store and don’t store audio information.
Refer to the DDC technical specification for exact storage capabilities.
DDCs may be reviewed with a separate PC based software package -
see “Event Viewing” section.
To install the DDC, remove the battery pack and push the DDC, label side up, into the thin slot in
the side of the AED centered over the battery pack opening. The card should click into place and
be flush with the surface of the slot. If the card does not push in all the way, it may have been
inserted upside down. In that case, remove the card, flip it over and try inserting it again.
To remove the DDC, press the card in all the way and then let go. The DDC will be partially ejected
and can be removed by pulling it the rest of the way out.
3.3 Installing the Active Status Indicator 9V Battery
A user-replaceable lithium 9V battery, located inside the battery pack, provides Active Status
Indicator (“ASI”) power. This auxiliary battery is used to provide standby indicator power
independently of the main lithium battery (contained in the battery pack) allowing the main battery
pack to have a significantly longer shelf and standby life.
The unit will operate without a 9V battery installed in the battery pack, but active status indication
will not be provided. If no 9V battery is installed, status can still be checked by turning the unit
on. Only a fresh 9V lithium battery should be used as a replacement. Refer to the Maintenance
section for more information on replacement batteries.
The 9V battery is installed into the battery pack in the 9V battery
compartment. To install, remove the cover covering the 9V
battery compartment by pushing on it sideways. The cover will
slide and detach from the battery pack. Insert the 9V battery
into the 9V battery compartment so that the contacts on the
battery touch the contacts in the battery pack. The orientation of
the battery contacts is shown in a picture on the inside bottom
of the 9V battery compartment. Replace the 9V battery
compartment door by placing it in the almost closed position and
then sliding it closed.