Defibtech DDU-100 User Manual

Deﬁbtech DDU-100 Semi-Automatic External Deﬁbrillator

AHA /ERC 2010

User Manual

ELECTRONIC

DISTRIBUTION

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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.

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.

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CAUTIO N: Federal law (USA) restricts this device to

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sale by or on the order of a physician.

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

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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

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.

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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.

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.

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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:

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• 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.

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

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DANGER

2.1.2 Battery Pack

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CAUTION

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WARNING

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WARNING

Hazardous electrical output. This equipment is for use only by qualiﬁed personnel.

Follow all battery pack labeling instructions. Do not install battery packs after the expiration date.

Lithium battery packs are not rechargeable. Any attempt to recharge a lithium battery pack may result in ﬁre or explosion.

Do not immerse battery pack in water or other liquids. Immersion in ﬂuids may result in ﬁre or explosion.

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Do not attempt to recharge, short-circuit, puncture, or deform battery. Do not

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WARNING

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CAUTION

2.1.3 Usage Environment

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DANGER

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DANGER

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CAUTION

expose battery to temperatures above 50°C (122°F). Remove battery when depleted.

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.

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.

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.

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.

2.1.4 Deﬁbrillation/Shock Delivery

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CAUTION

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WARNING

The DDU-100 AED should be stored and used only within the range of environmental conditions speciﬁed in the technical speciﬁcations.

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.

Improper use can cause injury. Use the DDU-100 AED only as instructed in the

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WARNING

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CAUTION

2.1.5 Maintenance

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WARNING

2.2 Improper Device Performance

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.

Disconnect all non-deﬁbrillator proof equipment from the patient before deﬁbrillation to prevent electrical shock hazard and potential damage to that equipment.

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.

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.

2.2.1 Usage Environment

Radio frequency (RF) interference from RF devices such as cellular phones and

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WARNING

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CAUTION

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.

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

Use only Deﬁbtech disposable self-adhesive deﬁbrillation/monitoring pads,

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WARNING

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CAUTION

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WARNING

2.2.3 Patient Analysis

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WARNING

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.

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).

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.

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.

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WARNING

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WARNING

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WARNING

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WARNING

CPR during analysis can cause incorrect or delayed diagnosis by the patient analysis system.

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.

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.

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.

In patients with cardiac pacemakers, the DDU-100 AED may have reduced

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WARNING

2.2.4 Shock Delivery

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WARNING

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2.2.5 Maintenance

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WARNING

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.

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.

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.

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.

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WARNING

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CAUTION

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WARNING

Use of damaged equipment or accessories may cause the device to perform improperly and/or result in injury to the patient or operator.

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.

No modiﬁcation of this equipment is allowed.

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2.3 General

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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

• Deﬁbtech Data

• 9V lithium battery

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.

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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.

If the battery pack is stored outside the unit for an extended period of time, removal of the 9V battery will extend the 9V battery’s life. Note that in an emergency situation, the battery pack may be used without a 9V battery. If needed, a non-lithium based 9V battery may also be used, but standby status indication life will be reduced.

Once the fresh 9V battery is installed, the battery pack status LED should periodically ﬂash green to indicate a ready state. If the indicator does not ﬂash, either the battery pack is defective or the 9V battery is discharged. Once the battery pack is installed into the unit, the DDU-100 AED’s Active Status Indicator should ﬂash green every ﬁve seconds.

3.4 Installing and Removing the Battery Pack

The lithium battery pack provides power to the DDU-100 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.

In an emergency, the battery pack can be used without a 9V battery, but under normal operating conditions the 9V battery should be installed. Do not install the battery pack after the expiration date printed on the label. The battery pack is non-rechargeable.

A green Active Status Indicator on the label side of the battery pack will blink periodically to indicate that the battery pack is ready for use. If the status indicator is not blinking, either the 9V status battery has discharged or the battery pack is not suitable for use. If the indicator does not blink after a new 9V battery has been installed, the battery pack should no longer be used and should be removed from service. When the battery pack is in the AED, a “beep” will provide notice that the 9V battery’s capacity is low and that the 9V battery should be replaced.

To insert the battery pack into the DDU-100 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 pack all the way in until the latch clicks. If the pack does not slide all the way in, it is most likely inserted upside down. Once fully inserted, the battery pack surface should be ﬂush 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.

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Within moments of insertion (if a non-discharged 9V ASI battery is installed) the DDU-100 will turn on and run a battery pack insertion self-test. The unit will automatically shut off after the test is run. Afterwards, the Active Status Indicator on the top corner of the DDU-100 AED will periodically ﬂash (if a nondischarged 9V ASI battery was previously installed in the battery pack). If the indicator ﬂashes green, the AED and battery pack are functioning properly, if the indicator ﬂashes red, there is a problem. Refer to the “Checking DDU-100 AED Status” section for more details on the meaning of the indicator.

3.5 Connecting the Pads

The DDU-100 AED deﬁbrillation/monitoring pads are supplied sealed in a pouch with the connector and part of the cable exposed. This allows the pads to be stored in a pre-connected state for rapid deployment during an emergency.

Caution: DO NOT remove the deﬁbrillation pads from the sealed package until the 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.

Note: The DDU-100 AED is designed to be stored with the pads connector already installed. This simpliﬁes the procedure for setting up and operating the device in an emergency.

their expiration date should not be used and should be discarded.

Insert the connector end of the deﬁbrillation pad cable into the pads connector port on the top-left corner of the DDU-100 AED as shown. Insert pads connector ﬁrmly until it is fully seated in the unit.

The connected pad package can then be stored in the pad storage slot in the back of the DDU-100 AED. After connecting the pads connector to the unit, push the pad package, with the pictures on the package facing out, rounded end ﬁrst, into the pad holder compartment on the back of the AED. When the pad package is fully inserted, press the pad cable into the groove in the back of the unit to hold it in place and tuck any excess cable behind the pad package.

Caution: The pads are intended for one time use only and must be discarded after use or if the package has been opened.

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First, check to ensure that the pad package has not expired. Pads past

3.6 Performing Manually Initiated Self-Tests

Upon initial setup, perform a manually initiated Self-Test as described in the following paragraph.

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. The unit will then prompt you to “press ﬂashing shock button.” When prompted, press and release the ﬂashing SHOCK button. 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 “UNIT 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. The user should refer to the “Troubleshooting” section in Chapter 5 of this manual for appropriate action.

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.

In addition, every time a battery pack with a non-depleted 9V battery is inserted, the unit runs a Battery Pack Insertion Self-Test to test the battery pack. When the test is completed, the unit reports the status of the battery pack and powers off. The unit may then be immediately used by pressing the ON/OFF button again.

3.7 Storing the DDU-100 AED

The DDU-100 AED (preferably with pads attached) should be stored in environmental conditions within range of the speciﬁcations - refer to the “Environmental” section of “Technical Speciﬁcations”. The unit should also be stored so that the Active Status Indicator can be readily seen.

The Active Status Indicator should periodically blink with a green light. If it blinks with a red light or does not blink at all, the DDU-100 AED needs servicing – refer to the “Checking Active Status Indicator” section for more information.

Deﬁbtech recommends storing your AED in an easily accessible location.

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