Defibtech Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120 Operating Manual

DAC-A581- EN-DG

Defibtech Automated External Defibrillator

• Lifeline/ReviveR DDU-100

• Lifeline/ReviveR AUTO DDU-120

Operating Guide

For concise guidance on
set-up, use, maintenance
and technical specifications

check pads

do not touch patient

analyzing

check pads

do not touch patient

analyzing

ELECTRONIC

DISTRIBUTION

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DAC-A5 81-EN-D G DAC-A5 81-EN-D G

Issued: 2018-06-08

This manual applies to the following models and trade names

Trade Names Model Number

Lifeline/ReviveR DDU-100

Lifeline/ReviveR AUTO DDU-120

The Lifeline/ReviveR is referred to as the DDU-100 from this point forward in this manual.
The Lifeline/ReviveR AUTO is referred to as the DDU-120 from this point forward in this manual.
Statements that apply to all trade names/model numbers listed above are referred to in this
manual as “DDU-100 Series.”

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
any 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, L.L.C. with respect to the products contained
herein.

Copyright

Copyright © 2018 Defibtech, L.L.C.

All rights reserved. Copyright questions should be directed to Defibtech.
For contact information, refer to the “Contacts” section of this document.

Tracking

U.S.A. fed eral regulations require Defibtech to maintain reco rds for each AED it distributes
(reference 21 CFR 821, Medical Devic e Tracking). These re quirements also apply anytime
there is a change in the AED’s loc ation, including if you move, sell, donate, give away,
export or even throw it away. We depend o n AED owners/users to contact us when the se
things happen to ensure the tra cking information remains accurate in the event we need to
share important pro duct notices. If your location is outside t he U.S.A., we ask you share
your information for exactly th e same reasons. To keep your information up to date, please
visit ww w.defibtech.com/regi ster.



CA UT I ON : Federal law (USA) restricts this device to

sale by or on the order of a physician.

Contents

Quick Use Instructions ............................................................................ 4

When to U se (Indications, Contraindications, Summary of Primary

Clinical Studies , Potential Adverse Effects of the Device on Health,

Operator Training Requirements) .............................................................5

Diagram of Components .........................................................................6

Setting Up the AED .................................................................................. 8

Using the AED ........................................................................................ 10

The Defibrillation Pads .......................................................................... 14

The Battery Pack .................................................................................... 15

The Defibtech D ata Card (optional)...................................................... 16

Checking AED St atus ............................................................................. 17

Maintenance ...........................................................................................18

Troubleshooting .....................................................................................20

Warnings and Cautions .........................................................................22

Technical Specifications ........................................................................ 24

Glossary of Symb ols ..............................................................................26

Warranty Information ............................................................................29

Contacts ..................................................................................................30

This Operating Guide is to be used for concise guidance on set-up, use,

maintenance and technical specifications on DDU-100 and DDU-120 AEDs.

For comprehensive training on set-up, use and maintenance as well as complete

technical specifications, refer to the User Manual at www.defibtech.com

IM PORT ANT: This Operating Guide only applies to
DDU-100 and DDU -120 AEDs running software version

3.2 or higher that include the mark ing shown at left on
the rear panel AED pad holder lab el as shown at right.

Please refer to www.defibtech.com/support for
information about DDU -100 and DDU-120 AEDs running
earlier software versions.

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For more detailed information, refer to the User Manual (at www.defi btech.com).

QUI CK US E INSTR UCTION S WHEN TO USE

1

2

3

PRESS “ON”

BUTTO N

APPLY PADS

FOLLOW AED

INSTRUCTIONS

INDICATIONS

Lifeline/ReviveR DDU -100 and Lifeline/ReviveR AUTO DDU -120 Automated External
Defi brillators (AE Ds) are indicated for use on victims of sudden cardiac arrest (SC A)
who are:

• Unconscious and unresponsive

• Not breathing or not breathing normally

Lifeline/ReviveR DDU -100 and Lifeline/ReviveR AUTO DDU -120 AEDs may be used
with Defi btech adult defi brillation pads (model number DDP -100). For patients under 8
years old, or weighing less than 55 lbs ( 25 kg), use Defi btech child/infant defi brillation
pads (model number DDP -200P), if available.

CONTRAINDICATIONS

Lifeline/ReviveR DDU -100 and Lifeline/Revi veR AUTO DDU-120 Automated External
Defi brillators (AEDs) should not be used if the victim is resp onsive or conscious.

IM PO RTAN T

Do not delay therapy to determine exact age or weight. If pedi atric pads are not
available, apply adult pads in the po sition as shown for a child/infant and use the AED.

OPERATOR TRAINING REQUIREMENTS

In order to safely and effectively operate the DDU -100 Series AED, a person shall have
met the following requirements:

• Defi btech DDU-100 Series AED and/or defi brillation training as required by
local, state, provincial, or national regulatio ns.

• Any additional training as required by the authorizing p hysician.

• Thorough knowledge and unde rstanding of the material presented in the User
Manual (available for viewing/downl oad at www.defi btech.com).

Refer to User M anual Section 8.1.6 for Summary of Primary Clinical Stud ies and
User Manual Se ction 8.1.7 for Potential Adverse Effect s of the Device on Healt h.

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For more detailed information, refer to the User Manual (at www.defi btech.com).

DIAGRAM OF COMPONENTS

N

H

M

G

F

E

D

C

B

A

K

J

I

L

O

A. Speaker. The speaker projects the voice prompts when the 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 † (DDU-100 ONLY). This button will fl ash when a shock is recommended - push

this button to deliver the shock to the patient. This button is disabled at all other times.

†

IMPORTANT: On the fully-automatic DDU-120, a SHOCK Required Indicator which fl ashes

when a shock is recommended and the unit has charged and is to deliver a shock is in the
SHOCK button location. Do not touch the patient while this indicator is fl ashing.

C. “analyzing” LED (Light Emitting Diode). This green LED fl ashes when the AED is analyzing

the patient’s ECG rhythm.

D. “do not touch patient” LED. This red LED fl ashes when the 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 fl ashes when the 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 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

the AED.

H. Battery pack. The battery pack provides a replaceable main power source for the AED.

I. Battery pack opening. Insert the battery pack fi rmly into this opening until the latch clicks into place.

J. Battery pack eject button. This button releases the battery pack from the AED. To remove the

battery pack, push the button until the battery pack is partially ejected from the unit.

K. Active Status Indicator (ASI). The ASI indicates the current status of the AED. This indicator fl ashes

green to indicate the unit has passed its last self-test and is ready for use. It fl ashes red to indicate
unit needs attention from the user or needs servicing.

L. Patient pads. The defi brillation pads that are placed on the patient. The pads should be stored in

the pad storage area on the back of the unit.

M. Defi btech Data Card (DDC). This optional plug-in card provides enhanced storage capabilities to

the AED.

N. Active Status Indicator (ASI) battery. This 9V lithium battery provides power to the Active

Status Indicator (ASI). 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 AED.

P. Operating Guide. Quick reference information for the DDU-100 and DDU-120 AED.

(The full DDU-100 Series AED User Manual can be found at www.defi btech.com.)

P

*DDU-100 series AEDs will continue to perform standby and ASI functions without the 9V ASI

battery installed, but battery pack standby life will be reduced.

Defi btech Automated
External Defi brillator

Operating Guide

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DAC-A5 81-EN-DG DAC -A581-EN -DG

For more detailed information, refer to the User Manual (at www.defi btech.com).

SETTING UP THE AED

1

2

CON NECT

THE PADS TO

THE AED

INSTALL THE

LITHIU M

9V ASI BATTERY

INTO THE

BATTERY PAC K*

The DDU-100 Series AED is designed to be stored in a “ready”

state so that few steps are required to begin using the AED.

4

5

CHECK THE

STAT US

READ THE

USER MANUAL

(at www.defi btech.com)

When the AED i s off,

the Active Status Indicator
(ASI) should fl ash green. If the
ASI fl ashes red, is solid red, or
if there is no fl ashing light , the

unit requires service.

For more information,

refer to page 17.

Comprehensive information about the DDU-100 Series AED

can be found in the User Manual (at www.defi btech.com).

3

INSTALL THE

BATTERY PAC K

INTO THE AED

Ensure that the pads package has not expired.

Expired pads must not be used.

For more information, refer to page 14.

Ensure that the lithium 9V battery has not expired.

For more information, refer to page 15.

*NOTE: DDU-100 series AEDs will continue to perform

standby and ASI functions without the 9V ASI battery

installed, but battery pack standby life will be reduced.

Ensure that the battery pack

has not expired. Expired battery

packs must not be used.

When the battery pack is

installed, the AED will turn on

and run a battery pack test.

Wait for the test to complete

and for the unit to turn off.

For more information,

refer to page 15.

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DAC-A5 81-EN-DG DAC -A581-EN -DG

For more detailed information, refer to the User Manual (at www.defi btech.com).

USING THE AED

1

2

TURN

AED ON

PREPARE

THE PATIENT

Press ON/OFF but ton to turn AED on.

Follow the voice prompt instructions.

(NOTE: To power off the AED at any time, press and hold

the ON/OFF button for approximately two seconds.)

Remove clothing from patient’s chest.

If necessary, dry chest and remove excess chest hair.

3

4

PREPARE PADS

PLACE PA DS

Peel adhesive pads

from blue liner.

Tear open

pads package.

Apply pads to patient’s bare chest.

For more information, refer to page 14.

ADULT

PATIENT

CHILD/INFANT

PATIENT

OR

If the patien t is unconscious o r unresponsi ve, and is

not breath ing or not breath ing normally, ensure e mergency

medical as sistance has b een called an d start using t he AED.

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DAC-A5 81-EN-DG DAC -A581-EN -DG

For more detailed information, refer to the User Manual (at www.defi btech.com).

USING THE AED (continued)

5

6

STAN D C LEA R

IF INSTRUCTED,

PRESS SHOCK

BUTTO N

When instructed, do not touch the patient.

7

8

PERFORM CPR

CONTINUE

TO FOLLOW

INSTRUCTIONS

Follow instructions to perform CPR, if needed.

Continue to follow the voice prompt instructions.

If instructed, press “SHOCK” button.

IM POR TANT: The semi-automatic DD U-100 A ED

will deliver the shock after the SHOC K button has

been pressed; the fully-automatic D DU-120 AED

will shock the patient automatically without a ny user

intervention. D o not touch the pat ient while th e

SHOCK Requ ired (“auto”) indicator i s fl ashi ng.

auto

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DAC-A5 81-EN-DG DAC -A581-EN -DG

For more detailed information, refer to the User Manual (at www.defi btech.com).

THE BATTE RY PACKTHE DE FIB RILLATI ON PADS

HOW TO CONNECT THE PADS

Insert the connector end of the defi brillation pad cable into the pads connec­tor socket on the top-left corner of the DDU-100 Series AED as shown at left.
Insert the pads connector fi rmly until it is fully seated in the unit. The connec­tor will only fi t in one way – if the connector does not fi t, rotate the connector
before trying again.

The connected pads package should then be
stored in the pad storage area on the back of the

DDU-100 Series AED (see diagram at right). After
connecting the pads connector to the unit, push the pads package,
rounded end fi rst, with the pictures on the package facing out, into the
pad storage area. When the pads package is fully inserted, press the
pad cable into the groove in the back of the unit to hold the cable in
place and tuck any excess cable behind the pads package.

WHICH PADS TO USE

WHEN TO REPLACE THE PADS

The Defi btech defi brillation pads are intended for one-time use only. The pads must be replaced
after each use or if the package has been damaged.

It is important to check the expiration date of the pads. The expiration date is printed on the outside
of the sealed package. Do not use pads past their expiration date. Discard expired pads. Use only
Defi btech defi brillation pads.

For adults and children

8 years or older or over

55 pounds (25 kg),

use adult pads

For infants and children under 8 years
or less than 55 pounds (25 kg), use child/
infant pads (NOTE: Child/infant pads can

be identifi ed by their blue connector

and blue pads package)

ADULT PADS CHILD/INFANT PADS

IM POR TANT: DDU-100 Series AEDs that carry the mar king shown at left
on the pad holder label on the unit’s rear panel (see top of pa ge 3) should
use battery packs that also inc lude this marking. Earlier model battery packs
without this marking will function during a resc ue, but should not be used
for standby. If an earlier model battery p ack is installed, the AED will prompt
the user on shut down that an unknown batter y type is present. The battery
pack should be replaced with one th at includes the marking shown at left.

INSTALLING THE ACTIVE STATUS INDICATOR 9V BATTERY

To meet battery pack specifi cations (see pages 24 -25), a lithium 9V battery
should be installed into the battery pack. NOTE: While DDU-100 Series AEDs

will operate rescue and standby functions with a battery pack that does not
contain 9V battery, battery pack standby life will be reduced.

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. Replace the 9V battery compartment door by placing it in the almost closed
position and then sliding it closed. Only a fresh 9V lithium battery should be used as a replacement.

INSTALLING AND REMOVING THE BATTERY PACK

The lithium battery pack provides power to the DDU-100 Series AED. Before inserting the battery
pack into the AED, the 9V lithium battery should be installed in the battery pack itself as described
in the previous section. Do not install the battery pack after the expiration date printed on the label.
The battery pack is non-rechargeable.

To insert the battery pack into the AED, orient the battery pack so that
the label faces up. Make certain that the battery opening in the side
of the AED is clean and clear of any foreign objects. Insert the battery
pack into the opening in the side of the AED. Slide the battery pack
all the way in until the latch clicks. If it does not slide all the way in, it
is most likely inserted upside down. Once fully inserted, the battery
pack surface should be fl ush with the side of the AED. To remove the
battery pack, push the battery eject button on the side of the AED.
After the battery pack is partially ejected, pull the battery pack out.

Within moments of insertion, the AED will turn on and run a battery pack insertion self-test. The
AED will announce “Battery OK” after successful completion of the test. The unit will automatically
shut off after the test is run. Afterwards, the Active Status Indicator on the top corner of the AED
will periodically fl ash. If the indicator fl ashes green, the AED and battery pack are functioning
properly; if this does not happen, there is a problem. Refer to page 17 for more details on the
meaning of the indicator.

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DAC-A5 81-EN-DG DAC -A581-EN -DG

QUICK USE INSTRUCTIONS

For more detailed information, refer to the User Manual (at www.defi btech.com).

THE DEFIBTECH DATA CARD (optional) CHECKING AE D STATUS

ACTIVE STATUS INDICATOR (ASI)

Once a fully-functional b attery pack with a non- discharged 9V battery is installed in the AED, an
LED indicator located in the corner of the unit a ctively indicates unit status. If the unit is fully
operational, the Active Status Indic ator (“ASI”) will blink green and if the unit needs attention, the
ASI will blink red. When the AS I blinks red, the unit will also “beep” periodically to call attention
to its elf.

ACTIVE
STATUS

INDICATOR

• Off: Battery pack not installed or the AED is defective. Install a functional

battery pack in the AED.

• Steady-on green: The AED is ON and operating normally.

• Blinking green: The AED is OFF and ready to operate normally.

• Blinking red: The AED is OFF and the AED or battery pack needs attention.

Refer to “Troubleshooting” on page 20 or call Defi btech for service.

SE LF-TE STS

Power-on self-tests are performed every time the unit is turned on to test the basic operation of
the unit. The unit also performs daily, weekly, monthly and quarterly self-tests automatically to
check the integrity of the unit’s hardware and software.

Manually-initiated self-tests may be run at any time by the user to test the AED’s systems,
including the charging and shocking functions (the shock is internally dissipated and no voltage will
be present at the pads).

Note: Every time the manually initiated self-test is run, the unit does an internal shock test. This
test reduces the capacity of the battery pack by one shock.

To perform a manual self-test, begin with the unit powered off. Press and hold the ON/OFF button
until the unit announces that it is performing a self-test – this should take approximately 5 seconds.
Once you hear the announcement, release the ON/OFF button and follow the AED’s spoken
instructions until the test is complete. The unit will run a series of internal tests, including charge and
shock tests. The manually initiated self-test can be aborted by pressing the ON/OFF button again to
turn the unit off. When the self-test is complete, the unit will announce its status and power off.

• If the self-test passes: The unit will announce: “AED OK” and power off. The unit may then be

immediately used by pressing the ON/OFF button again.

• If the self-test fails: The unit will announce the symptom. Refer to the “Troubleshooting”

section on page 20.

INSTALLING AND REMOVING THE DEFIBTECH DATA CARD (DDC CARD)

Each time the AED is used, an event fi le is created on the Defi btech Data Card (if installed). If the
unit was used to treat a patient, the DDC in the unit should be removed and provided to the patient’s
care provider. A new DDC should be installed before the next use.

To remove the DDC, fi rst remove the battery pack by pressing the
battery pack eject button on the side of the unit. The DDC card is
located in a slot directly above the battery pack opening in the unit.
To remove the DDC card, press the DDC in all the way and then
release. The DDC will be partially ejected and can be removed by
pulling it the rest of the way out. To install a new DDC, insert the
DDC, label side up, in the thin slot on the top of the opening for the
battery pack. The card should click into place and be fl ush 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, fl ip
it over and try inserting it again.

Note: A DDC card is not required for the AED to operate. Even if a DDC card is not installed,
relevant event information will still be recorded internally. The AED will still operate properly even
after a “replace data card” message.

!

CAUTION

Using non-Defi btech Data Cards (DDC cards) may damage
the unit and will void the warranty.

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QUICK USE INSTRUCTIONS

For more detailed information, refer to the User Manual (at www.defi btech.com).

MAINTENANCE

ROUTINE MAINTENANCE

The DDU-100 Series AED is designed to be very low maintenance. Simple maintenance tasks are
recommended to be performed regularly to ensure its readiness (see sample maintenance table
below). Different maintenance intervals may be appropriate depending on the environment where
the AED is deployed, and ultimately the maintenance program is at the discretion of the emergency
response program’s medical director.

Daily Monthly After Each Use Action

• • •

Check that Active Status Indicator (ASI) is fl ashing green

• •

Check the condition of the unit and accessories

•

Run manually-initiated self-test

•

Replace pads

•

Check pads and battery pack expiration dates

•

Check the DDC, if one was installed

Note: If the unit has been dropped, mishandled, or abused, a manually-initiated self-test should
be performed.

If the unit still requires attention after a manually-initiated self-test has been performed, refer to
“Troubleshooting” on page 20 or call Defi btech for service (refer to “Contacts” section on page 30).

CHECKING THE CO NDITION OF THE UNIT AND ACCESSORI ES

Inspect the unit for cracks or other signs of damage on the case, as well as dirt or contamination,
especially in the areas around the connector socket and battery pack opening. If any cracks or other
signs of damage are observed, remove the unit from service and contact an authorized service
center. If any dirt or contamination is observed, refer to the “Cleaning” section of the full User
Manual (available at www.defi btech.com).

It is important that the patient pads and the battery packs not be used past their expiration dates.
The expiration date of the pad package is printed on the outside of the sealed package. The
expiration date of the battery pack is printed on the label on the pack. The battery pack should be
removed and replaced by this date; when the battery pack is used up, the unit will indicate “battery
low” or “replace battery now” and the Active Status Indicator will fl ash red.

Once an accessory is past its expiration date, it should be replaced immediately. Follow the
instructions in the “Installing and Removing the Battery Pack” and “How to Connect the Pads”
sections of this guide to replace the part with an unexpired part. Patient pads should be discarded.
Battery packs should be appropriately recycled.

Run manually-initiated self-test

Run manually-initiated self-test

CLEAN ING

Periodically clean the AED of any dir t or contaminants on the case and connector socket. The following
are important guidelines to be adhered to when cl eaning the device:

• The battery pack sho uld be installed when cleaning the AED.

• Do not immerse the AED in fl uids or allow fl uids to enter the unit. Use a soft cloth to wip e the
case clean.

• Do not use abrasive materials or strong solvents such as acetone or a cetone-based cleaning
agents. The following cleaning agents are recomme nded for cleaning the AED case and the
connector socket:

– Soapy water
– Ammonia based cleaners
– Hydrogen perox ide
– Isopropyl alcohol (70 percent solu tion)
– Chlorine bleach (30 ml /liter water)

• Ensure that the connector socket is completely dry before reinstalling the p ads cable. After
cleaning the device and before returning it to service, always tur n the unit on for a few seconds,
which will cause the unit to run a standard power- on self-test.

Please note that none of the items provided with the DDU -100 Series AED (including the AED it self)
are sterile or require sterilization.

!

WARNING

Do not sterilize the DDU-100 Series AED or its accessories.

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For more detailed information, refer to the User Manual (at www.defi btech.com).

TROUBLESHOOTING

The following table lists the common c auses for problems, the possible cause, and the possib le
corrective actions. Refer to the User Manual (available at w ww.defi btech.com) for detailed
explanations on how to implement the corrective acti ons.

To have the unit report what the root cause of the problem is, power the AED on an d then power it off
by pressing the ON/OFF but ton for approximately two seco nds. While powering off, the unit should
issue a voice prompt that details the cause of the problem. Use t he chart below to determine the
appropriate corrective action base d upon what prompt was spoken by the unit.

If the unit continues to be non-functio nal, call Defi btech for ser vice (refer to the “Contacts” section on
page 3 0).

Symptom Possible Cause Corrective Action

Unit will not turn on

Battery pack not inserted Insert battery pack

Battery pack depleted or needs
servicing

Replace battery pack or call for
service

Unit needs servicing Call for service

Unit immediately turns off

Battery pack depleted Replace battery pack

Unit needs servicing Call for service

ASI fl ashes red and/or unit
makes periodic “beep” sound

Unit may need servicing

Power unit on and then power
off by pressing ON/OFF button
for approximately two seconds;
note problem indicated by voice
prompt and, if necessary, call for
service

Battery pack non-functional Replace battery pack

Defi brillation pads are not pre­connected to unit

Connect defi brillation pads to
unit

ASI does not fl ash at all while
the unit is in standby (powered
off)

Battery pack not inserted Insert battery pack

Battery pack is low or needs servicing

Replace battery pack or call for
service

Unit needs servicing Call for service

“Power on test failed, service
code ‘xxx’” prompts

Unit needs servicing

Record code number and call for
service

“Battery test failed, service
code ‘xxx’“ prompts

Battery pack needs servicing

Record code number and replace
with new battery pack

“Service required” prompt Unit needs servicing Call for service

“Replace battery now” prompt Battery pack capacity is critically low

Unit may not deliver a shock,
replace battery pack immediately

“Battery low” prompt Battery pack capacity is getting low

Replace battery pack as soon as
possible

Symptom Possible Cause Corrective Action

“Unknown battery type”
prompt

Battery pac k not recommended for
use with unit (see top of pa ge 15).

Replace installed battery pack
with recommended battery pack

“Pads missing” prompt Pads not connected

Make sure pads connector
is oriented correctly and fully
inserted into unit

“Plug in pads connector”
prompt

Pads connector not plugged in Plug in pads connector

Pads connector broken Replace pads

Unit’s connector broken Call for service

“Apply pads to patient’s bare
chest as shown” prompt

Pads not connected to patient Place pads on patient

Pads not making good connection to
patient

Check pad connection to patient

Pads or pad cable damaged Replace pads

“Poor pad contact to patient”,
“Press pads fi rmly”, “Replace
pads”, “Non-rescue pads”
or “Warning” prompt

Dry pads Replace pads

Partial pad connection

Check that pads are placed
securely on patient

Pads touching

Separate pads and place
correctly on patient

Non-rescue pads (e.g. trainer pads)
connected while in AED (rescue)
mode

Replace non-rescue pads with
rescue pads

“Check pads” prompt Pads touching

Separate pads and place
correctly on patient

“Stop motion” prompt Patient motion has been detected Stop patient motion

“Stop interference” prompt

External interference has been
detected

Stop external interference

“Analyzing interrupted”
prompt

Motion or interference detected Stop motion or interference

“Shock cancelled” prompt

Patient’s ECG rhythm changed No action necessary

Shock button not pushed within
30 seconds (DDU-100 ONLY)

Push shock button within
30 seconds (DDU-100 ONLY)

Low battery – insuffi cient to charge Replace battery pack

Hardware failure

Run manually initiated Self-Test,
return unit for servicing

Bad pad to patient connection

Check that pads are placed
securely on patient

Dry pads Replace pads

“Replace data card” prompt

DDC card is full

Replace DDC card with a card
that is not full

DDC has failed Replace DDC card

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DAC-A5 81-EN-DG DAC -A581-EN -DG

For more detailed information, refer to the User Manual (at www.defi btech.com).

WARNINGS A ND CAUTIONS

!

WARNINGS:

Immediate hazards that will result in
serious personal injury or death

.

•

Hazardous electrical output. This equipment is for use only by

qualifi ed personnel.

•

Possible fi re or explosion. Do not use in the presence of

fl ammable 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 defi brillation, if necessar y.

•

The DDU-100 Series AED has not been evaluated or approved
for use in hazardous locations as defi ned in the National Electric
Code standard. In compliance with IEC classifi cation, the DDU­100 Series AED is not to be used in the presence of fl ammable
substance/air mixtures.

Conditions, hazards, or unsafe practices that may
result in serious personal injury or death.

•

Not intended to be used in an environment with high-

frequency electrosurgical equipment.

•

Improper use can cause injury. Use the DDU-100 Series AED

only as instructed in the User Manual and Operating Guide. The
DDU-100 Series AED delivers electrical energy that can potentially
cause death or injury if it is used or discharged improperly.

•

Improper maintenance can cause the DDU-100 Series AED

not to function. Maintain the DDU-100 Series AED only as
described in the User Manual and Operating Guide. The AED
contains no user-serviceable parts — do not take the unit apart.

•

No modifi cation of this equipment is allowed.

•

Electrical Shock Hazard. Dangerous high voltages and currents

are present. Do not open unit, remove cover (or back), or attempt
repair. There are no user serviceable components in the DDU­100 Series AED. Refer servicing to qualifi ed service personnel.

•

Lithium met al battery packs are not rechargeable. Any attempt

to recharge a lithium metal battery pack may result in fi re or
explosion. Do not attempt to recharge the primary battery pack
or lithium 9V battery.

•

Do not immerse battery pack in water or other liquids.

Immersion in fl uids may result in fi re or explosion.

•

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.

•

Do not let fl uids get into the DDU-100 Series AED. Avoid

spilling fl uids on the AED or its accessories. Spilling fl uids into
the DDU-100 Series AED may damage it or cause a fi re or
shock hazard.

WARNINGS (continued)

•

Do not sterilize the DDU-100 Series AED or its accessories.

•

Use only Defi btech disposable self-adhesive defi brillation pads,

battery packs, and other accessories supplied by Defi btech
or its authorized distributors. Substitution of non-Defi btech
approved accessories may cause the device to perform
improperly.

•

Do not open sealed pads package until pads are to be used.

The packaging should be opened only immediately prior to use,
otherwise the pads may dry out and become non-functional.

•

Do not touch the patient during defi brillation. Defi brillation

current can cause operator or bystander injury.

•

Do not allow pads to touch metal objects or equipment in

contact with the patient. Do not touch equipment connected to
the patient during defi brillation. Disconnect all non-defi brillator
proof equipment from the patient before defi brillation to prevent
electrical shock hazard and potential damage to that equipment.

•

Do not shock with defi brillation pads touching each other. Do

not shock with gel surface exposed.

•

Do not allow defi brillation 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 defi brillation and may divert
defi brillating energy away from the heart.

•

The defi brillation 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.

•

Avoid contact between parts of the patient’s body and

conductive fl uids such as water, gel, blood or saline, and
metal objects, which may provide unwanted pathways for
defi brillating current.

•

Aggressive or prolonged CPR to a patient with defi brillation

pads attached can cause damage to the pads. Replace the
defi brillation pads if they become damaged during use.

•

Possible Radio Frequency (RF) interference from RF devices

such as cellular phones and two-way radios can cause
improper AED operation. Normally using a cell phone near the
AED should not cause a problem; however, a distance of 2
meters (6 feet) between RF devices and the DDU-100 Series
AED is recommended.

•

CPR during analysis can cause incorrect or delayed diagnosis

by the patient analysis system.

•

Do not place adult defi brillation pads in the anterior-posterior

(front-back) position. A shock or no shock decision may be
inappropriately advised. The DDU-100 Series AED requires
that the adult defi brillation pads be placed in the anterior­anterior (front-front) position.

WARNINGS (continued)

•

Some ver y low amplitude or low frequency VF rhythms may

not be interpreted as shockable. Some very low amplitude
or low frequency VT rhythms may not be interpreted as
shockable.

•

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. If the patient is
being transported, stop vehicle before beginning ECG analysis.

•

In patients with cardiac pacemakers, the DDU-100 Series 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.

•

During defi brillation, air pockets between the skin and

defi brillation pads can cause patient skin burns. To help
prevent air pockets, make sure self-adhesive defi brillation pads
completely adhere to the skin. Do not use dried out or expired
defi brillation pads.

•

Defi brillation may cause skin burns around the defi brillation

pads area.

•

User-initiated and automatic self-tests are designed to assess

the DDU-100 Series 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.

•

Use of damaged equipment or accessories may cause the

device to perform improperly and/or result in injury to the
patient or operator.

•

In the event the voice prompts cannot be heard for any reason

(e.g. noisy environment), follow the LEDs on the front of the
AED to complete the rescue.

•

It may be possible for the AED to not detect a shockable

rhythm, not deliver a shock to a shockable rhythm or not
deliver the intended energy during defi brillation.

•

It may be possible that the AED recommends a shock for a

non-shockable rhythm, and if a shock is delivered, VF or cardiac
arrest may occur.

•

Even if defi brillation occurs, the sudden cardiac arrest event

may not result in survival.

•

Defi brillation may cause myocardial damage or post-shock

dysfunction.

•

Therapy cannot be delivered while an AED software update
is in process.

•

Do not turn off the AED or remove the battery pack or the

update data card until an AED software update process is
complete as these actions may render the AED incapable
of delivering therapy. If any of these interruptions occur,
restart the update procedure from the beginning.

!

CAUTIONS:

Conditions, hazards, or unsafe practices that
may result in minor personal injury, damage to the
DDU-100 Series AED, or loss of data.

•

Follow all battery pack labeling instructions. Do not install

battery packs after the expiration date.

•

Follow all defi brillation pad label instructions. Use defi brillation

pads prior to their expiration date.

•

The defi brillation pads should not be in continuous contact
with the patient’s skin for more than 24 hours.

•

Allergic dermatitis or a minor skin rash may result in patients

that are sensitive to the materials used for the defi brillation
pads. Remove the defi brillation pads from the patient as soon
as practical.

•

Recycle or dispose of lithium battery packs in accordance with

local, state, provincial, and/or national regulations. To avoid fi re
and explosion hazard, do not burn or incinerate the battery
pack. Do not crush.

•

Use and store the DDU-100 Series AED only within the

range of environmental conditions specifi ed in the technical
specifi cations.

•

If possible, disconnect the DDU-100 Series AED from the

patient prior to use of other defi brillators.

•

Using non-Defi btech Data Cards (DDC cards) may damage the

unit and will void the warranty.

•

Defi bView software is not intended for clinical use. Information

presented by Defi bView should not be used for making clinical
decisions.

•

Although the DDU-100 Series AED is designed for a wide

variety of fi eld use conditions, rough handling beyond
specifi cations may result in damage to the unit.

•

Federal Law (USA) restricts this device to sale by or on the

order of a physician.

24 25

DAC-A5 81-EN-DG DAC -A581-EN -DG

For more detailed information, refer to the User Manual (at www.defi btech.com).

TECH NICAL SPEC IFI CATIONS

PATIENT ANALYSIS

Automatically evaluates p atient impedance for
proper pad contact . Monitors signal quality and
analyzes patient ECG for shockable/non-shockable
rhythms.

SENSITIVITY/SPECIFICITY

Meets IEC 60 601-2-4 and AAM I-DF80
specifi cations and AH A recommendations

PATIE NT ANA LYSIS SYSTE M

TYPE

Automated exte rnal
defi b rillator

MODELS

DDU -100 and D DU-120

WAVE FOR M

Impedance
Compensated Biphasic
Truncated Exponential

RESCUE PROTOCOL

AHA/ ERC (default);
future protocols via fi eld
updates

ENER GY*

Adult: 150 Joules
Child/Infa nt: 50 Joules

CHARGE TIME

4 seconds or less
(from shock advised )**
Charge time may
increase at the end
of battery life and for
temperatures below
10°C

CONTROLS

Lighted ON/OFF button
Lighted Shock but ton

(DDU -100 only)

INDICATORS

• “check pads”

• “do not touch
patient”

• “analyzing”

• AED Status LED

• Shock Required LED
(DDU-120 only)

CPR PA CIN G

Metronome

VOICE PROMPTS

Extensive voice prom pts
guide user through
operation of the unit

DEFIBRILLATOR

*Nominal (±15%) delivered
into a 50 ohm load
**Typical, new battery, at 25°C

AUT OM ATIC

Automatic daily, weekly, monthly
and quarterly circuitry tests

BATTERY INSER TION

System integrity test on battery
insertion

PAD PR ESENC E

Pads precon nected tested daily

USER-INITIATED
Unit and battery p ack system test
initiated by the user

STATUS INDICATION

Visual and audible in dication
of unit status

SE LF-TE STS

Specifi cations subject to change without notic e.

MODEL

DBP-2800

TYPE

Lithium/Manganese
Dioxide Disposable,
recyclable, non­rechargeable

POWER

15VDC, 2800 mAh

CAPACITY*

300 shocks or 16 hours
of continuous operation

STANDBY LIFE*
7 years (installed in AED
with 9V battery)

LOW BATTERY
INDICATIONS

Visible
Audible

BATTERY PAC K (HIG H-CAPACITY)

*Typical, new battery, at 25°C

MODEL

DBP-1400

TYPE

Lithium/Manganese
Dioxide Disposable,
recyclable, non­rechargeable

POWER

15VDC, 1400 mAh

CAPACITY*

125 shocks or 8 hours
of continuous operation

STANDBY LIFE*
5 years (installed in AED
with 9V battery)

LOW BATTERY
INDICATIONS

Visible
Audible

BATTERY PAC K (STANDARD)

*Typical, new battery, at 25°C

MODELS

Adul t: DDP-10 0
Child/Infa nt: DDP-200P

SURFACE AREA

Adult: 16 inches

2

(103c m2)
(nominal, each pad)
Child/Infa nt: 7.75 inches

2

(50cm2)

(nominal, each pad)

TYPE

Pre-co nnected, single-use,
non-polarized, disposable,
self-adhesive electrodes
with cable and conne ctor

DEFIBR ILLATION / MONITORING PADS

INTERNAL EVENT RECORD

Select ECG segment s and rescue event parameters
are recorded and can be dow nloaded to a removable
data card

PC-BASED EVENT REVIEW

ECG with event tag display, and audi o playback
when available

REMOVABLE STORAGE (optional)
Up to 12 hours of ECG and event data storage
(no audio option) or up to 2 hours of au dio (audio
option). ECG and event storage on a remov able data
card. Actual lengt h of storage is dependent on card
capacity. Data ca rd must already be installed at the
time of event.

EVENT DOCUMENTATION

TE MPE RATUR E

Operating: 0 to 50° C (32 to 122°F)
One Hour Operating Temperatu re
Limit (extreme cold)*: -20 °C (-4°F)
Standby: 0 to 50° C (32 to 122°F)

RELATIVE HUMIDITY

Opera ting/St andby: 5%- 95%
(non-condensing)

ALTITUDE

-150 to 4500 meters (- 500 to
15,000 feet) per M IL-STD -810F

500.4 Pro cedure II

VIBRATION

Ground (MIL-STD -810F 514.5
Categor y 20)

Helicopter (RTCA/DO-160D,
Section 8.8 .2, Cat R. Zone 2,
Curve G)

Jet Aircraft (RTC A/DO-160D
Section 8. Cat H , Zone 2,
Curves B & R)

SHOCK/ DROP ABUSE
TOLERANCE

MIL-STD- 810F 516.5
Procedure IV (1 meter, any edge,
corner, or surface, in stan dby
mode)

SEALING/WATER
RE SIS TANCE

IEC 60529 c lass IP54; Dust
Protected, Splash Pro of,
(battery pack installed)

ESD

EN 61000-4-2
(15kV or direct contact up to 8k V)

EMC (Emission)

EN 55011 Class B Group 1
and FCC Part 15

EMC (Immunity)

EN 61000 -4-3 (20V/m)

EMC (Separation Distances)

DDU-100 Series A EDs
are intended for use in an
electromagnetic environment in
which radiated RF distu rbances
are controlled. The AE D user can
help prevent electromagnetic
interference by maintaining a
minimum distance bet ween
portable and m obile RF
communications equipment
(transmitters) and the AED.
Recommended separation
distances can be foun d in the
DDU-100 Series U ser Manual
at www.defi btech.com.

AIRCRAFT

Meet s RTCA /DO-16 0D,
Section 8, Cat H , Zone 2,
Curves B&R

ENVIRON MENTAL

SIZE

8.5 x 11.8 x 2.7 inches
(22 x 30 x 7 cm)

WEIGHT

Approximately 4. 2 lbs (1.9 kg)
with DBP-1400 ba ttery pack

Approximately 4. 4 lbs (2 kg)
with DBP-28 00 battery pack

PHYSICAL

0197

*From room temperature to

temperature extreme, one hour
duration.

26 27

DAC-A5 81-EN-D G DAC-A5 81-EN-D G

GLOSSARY OF SYMBOLS

Symbol Meaning



High voltage present.

!

Caution, consult accompanying documents.

SHOCK Button – Delivers defibrillation shock to the patient when the device is ready to shock.

(DDU-100 ONLY)

auto

SHOCK Required Indicator – Flashes to indicate that a shock is about to be delivered.

(DDU-120 ONLY)

ON/OFF/DISARM Button –

- Turns the device ON when it is OFF.

- Turns the device OFF when it is ON.

- DISARMS the device when it is charged and then turns the device OFF.

Do not expose to high heat or open flame. Do not incinerate.

Recyclable.

Consult operating instructions.

Refer to instruction manual / booklet.

YYYY

Do not damage or crush.

YYYY

Follow proper disposal procedures.

Meets the requirements of the European Medical Device Directive.

Meets the requirements of the Radio Equipment and Telecommunications Directive,
1999/5/EC.

Symbol Meaning

Operational temperature limitation.

Use by yyyy-mm-dd.

Defibrillation proof - Can withstand the effects of an externally applied defibrillation shock.
Internally powered with defibrillator-proof BF-type patient applied parts (per EN 60601-1).

Manufacturer.

YYYY-MM-DD

YYYY-MM-DD

Date of manufacture.

YYYY-MM-DD

Manufacturer and date of manufacture.

YYYY

Do not reuse.

YYYY

For USA users only.

Federal Law (USA) restricts this device to sale by or on the order of a physician.

YYYY

Catalogue number.

Keep dry.

Handle with care.

Transportation and storage requirements.
See environmental requirements on packaging.

28 29

DAC-A5 81-EN-D G DAC-A5 81-EN-D G

QUICK USE INSTRUCTIONSGLOSSARY OF SYMBOLS (continued)

Symbol Meaning

EC REP

Authorized European Representative:
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands

LATEX

Does not contain latex.

Lot number.

IP54

Dust protected; Protected against water jets.

Classified by TUV Rheinland of NA with respect to electric shock, fire, and mechanical hazard
only in accordance with UL 60601-1, CAN/CSA C22.2 No.601.1-M90, IEC 60601-1, and IEC
60601-2-4. Conforms to UL Standard UL 60601-1. Certified to CAN/CSA Standard C22.2 No.

601.1-M90.

Serial number.

Lithium manganese dioxide battery.

Product is not sterile.

WARRANTY INFORMATION

ORIGINAL END U SER’S LIMITED WARRANTY*

COVERAGE

Defibtech, LLC provides a limited warranty that the defibrillator
and its associated accessories (e.g., batteries and pads),
whether purchased concurrently with the defibrillator as part
of a configuration or separately, shall be substantially free
from defects in material and workmanship. Defibtech’s limited
warranty shall only extend to the original end user, where
the original end user purchased the items from an authorized
Defibtech, LLC retailer. This limited warranty may not be assigned
or transferred. The terms of the limited warranty in effect as of
the date of original purchase shall apply to any warranty claims.

LENGTH OF WARRANTY

The defibrillator’s limited warranty is for a period of eight (8)
years from the date of purchase. The battery’s limited warranty
is for a period of four (4) years from the date of purchase, but
in no event shall the limited warranty period extend past the
date printed on the battery. Single use accessories (e.g., the
pads) shall have a limited warranty up to use or for a period
up to the expiration date, whichever is earlier. The limited
warranty for all other accessories is for a period of one (1) year
from the date of purchase, or to the expiration date, whichever
is earlier.

LIMITED WARR ANTY LIMITATIONS

This limited warranty does not cover damage of any sort
resulting from, but not limited to, accidents, improper
storage, improper operation, alterations, unauthorized service,
tampering, abuse, neglect, fire, flood, war, or acts of God.
Additionally, this limited warranty does not cover damage of any
sort to the defibrillator or its associated accessories resulting
from the use of the defibrillator with unapproved accessories or
use of the accessories with unapproved medical devices. The
defibrillator and its associated accessories are not warranted
to be compatible with any other medical device.

LIMITED WARR ANTY VOIDED

The limited warranty is immediately voided if: the defibrillator
or its associated accessories are serviced or repaired by any
entity, including persons, not authorized by Defibtech, LLC;
specified maintenance is not performed; the defibrillator is used
with one, or more, unauthorized accessories; the associated
accessories are used with an unauthorized defibrillator; or
the defibrillator or associated accessories are not used in
accordance with Defibtech, LLC approved instructions.

EXCLU SIVE RE MEDY

At Defibtech, LLC’s sole discretion, Defibtech shall have the
option to repair, replace, or provide a credit. In the event
of replacement, Defibtech shall have the right at its sole
discretion to replace the item with a new, or refurbished, same
or similar item. Determination of a similar item shall be at
the sole discretion of Defibtech. In the case of replacement,
the replacement at a minimum shall reflect the prorated
time remaining for the item based on the remaining limited
warranty period. In the case of a credit, the credit shall be the
prorated value of the item based on the lower of the original
item cost of the same or similar item and the remaining limited
warranty period. In no event, shall the limited warranty period
of a replacement item extend past the limited warranty period
of the item it is replacing.

WARRANTY SERVI CE

In order to obtain warranty service, contact the retailer from
whom the item was purchased, or Defibtech, LLC customer
service. In the event an item must be returned, a Return
Material Authorization (RMA) number is required. Items
returned without an RMA number will not be accepted. The
item shall be shipped at the original end user’s expense to a
destination specified by the retailer or Defibtech, LLC.

OBLIGATIONS AND WAR RANTY LIMITS

THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND
SPECIFICALLY EXCLUDES AND REPLACES, TO THE DEGREE
PERMITTED BY APPLICABLE STATE LAW, ALL OTHER EXPRESS
OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED
TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.

NO PERSON (INCLUDING ANY AGENT, DEALER, OR
REPRESENTATIVE OF DEFIBTECH, LLC) IS AUTHORIZED TO
MAKE ANY REPRESENTATION OR WARRANTY CONCERNING
THE DEFIBRILLATOR OR ITS ASSOCIATED ACCESSORIES,
EXCEPT TO REFER TO THIS LIMITED WARRANTY.

THE EXCLUSIVE REMEDY WITH RESPECT TO ANY AND
ALL LOSSES OR DAMAGES RESULTING FROM ANY
CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE.
DEFIBTECH, LLC SHALL IN NO EVENT BE LIABLE FOR ANY
CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND,
INCLUDING, BUT NOT LIMITED TO, EXEMPLARY DAMAGES,
SPECIAL, PUNITIVE, COMMERCIAL LOSS FROM ANY
CAUSE, BUSINESS INTERRUPTION OF ANY NATURE, LOSS
OF PROFITS OR PERSONAL INJURY, EVEN IF DEFIBTECH,
LLC HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH
DAMAGES, HOWEVER OCCASIONED, WHETHER BY
NEGLIGENCE OR OTHERWISE, UNLESS APPLICABLE STATE
LAW DOES NOT ALLOW SUCH EXCLUSION OR LIMITATION.

*Applicable to defibrillators and associated accessories

having a date of manufacture on or after Janu ary 1, 2013. For
all others, refer to warranty information in effect at the time
of manufacture.

30

DAC-A581- EN-DG

QUICK USE INSTRUCTIONSCO NTACTS

Manufacturer

Defibtech, L.L.C.
741 Boston Post Road, Suite 201
Guilford, CT 06437 USA

Tel.: [phone] (Toll-free within North America)
1-[phone]
Fax: [phone]

Email:
sales@defibtech.com (Sales)
reporting@defibtech.com (Medical Device Reporting)
service@defibtech.com (Service and Repair)

This product and its accessories are manufactured and sold under license to at least one or
more of the following United States patents: 5,591,213; 5,593,427; 5,601,612; 5,607,454;
5,611,815; 5,617,853; 5,620,470; 5,662,690; 5,735,879; 5,749,904; 5,749,905; 5,776,166;
5,800,460; 5,803,927; 5,836,978; 5,836,993; 5,879,374; 6,016,059; 6,047,212; 6,075,369;
6,438,415; 6,441,582.

For additional patent information, please see:

www.defibtech.com/patents