Defibtech DDU-2450 Operating Guide

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Deﬁbtech DDU-2000 Series Automated External Deﬁbrillator

• DDU-2300

• DDU-2400

• DDU-2450

AHA/ERC 2010

Operating Guide

ELECTRONIC

DISTRIBUTION

DAC-E25 30EN- BC

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Notices

Deﬁbtech, LLC 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.

For more detailed information regarding the Deﬁbtech DDU-2000 Series AED, please refer to the User Manual on the Deﬁbtech User CD.

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.

Contents

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

When To Use ....................................................................................... 5

Diagram Of Components ................................................................... 6

Setting Up The AED ............................................................................ 8

Using The AED ...................................................................................10

Using The AED - ECG Display Monitor (DDU-2400 & DDU-2450 only) .... 14

Using The AED - Manual Mode (DDU-2400 only) ................................ 15

Checking AED Status ....................................................................... 16

Routine Maintenance ........................................................................17

The Deﬁbrillation Pads ......................................................................18

The Battery Pack ................................................................................19

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.

Dangers, Warnings, And Cautions ................................................... 20

Technical Speciﬁcations ................................................................... 22

Warranty Information ....................................................................... 24

Contacts ............................................................................................ 25

This DDU-2000 Series Operating Guide

is to be used for quick reference.

For comprehensive information go to the

User Manual on the Deﬁbtech User CD.

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QUICK USE INSTRUCTIONS WHEN TO USE

PRESS “ON”

BUTTON

APPLY PADS

FOLLOW AED

INSTRUCTIONS

IF INSTRUCTED,

PRESS “SHOCK”

BUTTON

WHEN TO USE THE AED (INDICATIONS)

The DDU-2000 Series Semi-Automatic External Deﬁbrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:

• Unconscious and unresponsive

• Not breathing

For patients under 8 years old or less than 55 pounds (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.

WHEN NOT TO USE THE AED

The AED should not be used if the patient shows any of the following signs:

• Conscious and/or responsive

• Breathing

• Has a detectable pulse

OPERATOR TRAINING REQUIREMENTS

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

• 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.

Manual Mode (DDU-2400) is intended for use only by qualiﬁed medical personnel trained in advanced life support skills and ECG recognition who want to deliver a shock independent of AED Mode.

ECG Monitor Mode (DDU-2400 and DDU-2450 only) is intended to be used by personnel trained in basic life and/or advanced life support, or other physicianauthorized emergency medical training. Users should be trained in ECG recognition to allow for rhythm and heart rate monitoring using standard ECG monitoring electrodes.

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For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

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DIAGRAM OF COMPONENTS

LL LA

Unit Serial Number

Display Screen –

Displays video, text prompts and information

SHOCK Button – Enabled/disabled by software to allow the user to discharge a shock to the patient

Speaker

ON/OFF Button –

Turns AED on and off

FRONT OF AED

Active Status Indicator (ASI) –

Indicates the current status of the AED

Pads Connector Socket – Socket for pads connector

Softkey Buttons

(Top, Center, Bottom) –

Buttons used to navigate

menus or select options

USB Port

Deﬁbtech

Data Card

(DDC Card)

(Optional)

USB and Deﬁbtech

Data Card (DDC Card)

Access Door – Access to the

USB connector port and

Deﬁbtech Data Card slot

Battery Pack Opening

Battery Pack

Eject Release Latch

Pad Storage Area

Pads Connector

ECG Monitoring Adapter

(Optional; DDU-2400/2450 only)

BACK OF AED

Deﬁbtech DDU-2000 Series Automated External Deﬁbrillator

• DDU-2300

• DDU-2400

• DDU-2450

Deﬁbrillation Pads

Expiration Date

(on back of package)

Battery Pack

Serial Number

Battery Pack

Expiration Date

BATTERY PACK

Operating Guide

OPERATING GUIDE

BOOKLET

Quick Reference

Deﬁbrillation

Pads

DEFIBTECH USER CD

Comprehensive User Manual

can be found on the CD

DEFIBRILLATION

PADS PACKAGE

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For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

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SETTING UP THE AED

The DDU-2000 Series AED is designed to be stored in a “ready”

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

CONNECT

THE PADS TO

THE AED

Ensure that the pads package has not expired.

Expired pads must not be used.

For more information refer to page 18 of this guide.

INSTALL THE

BATTERY PACK

CHECK THE

STAT U S

READ THE

USER MANUAL

(CD)

AED status OK

Battery status Expires 01/2018 Pads status Adult Expires 06/2018 AED S/N 099999999 Battery S/N 099999999 Software version V2.2

AED Status screen

AND

When the AED is off, the Active

Status Indicator (ASI) should ﬂash green. If the ASI ﬂashes red, is solid red, or if there is no ﬂashing light, the unit requires service.

For more information refer to page 16 of this guide.

With the AED off, press and release the CENTER softkey button. Ensure that the AED Status screen appears and that the “AED Status” is “OK”.

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 19 of this guide.

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Comprehensive information about the

DDU-2000 Series AED is found in the User Manual (on Deﬁbtech User CD).

For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

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USING THE AED

Turn the unit ON and then follow

the voice and display instructions.

Note

: When this Information Softkey Icon is present on the screen,

the user may press the corresponding softkey button for additional information with video instruction. To exit, press the softkey button again.

TURN

AED ON

PREPARE

THE PATIENT

Press “ON” button

PREPARE

ELECTRODE

PADS

PLACE PADS

Tear open

pads package

ADULT

PATIENT

Peel pads

from blue liner

CHILD/INFANT

PATIENT

Remove clothing from patient’s chest.

If necessary, dry chest and remove excess chest hair.

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For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

Apply pads to patient’s

bare chest as shown

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USING THE AED (continued)

Note

: When this Information Softkey Icon is present on the screen,

the user may press the corresponding softkey button for additional information with video instruction. To exit, press the softkey button again.

STAND CLEAR

IF INSTRUCTED,

PRESS SHOCK

BUTTON

When instructed, do not touch the patient

PERFORM CPR

Follow instructions to perform CPR

CONTINUE

TO FOLLOW

INSTRUCTIONS

If instructed, press “SHOCK” button

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Continue to follow the voice

and display instructions

For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

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USING THE AED - ECG DISPLAY MONITOR

(DDU-2400 AND DDU-2450 ONLY)

USING THE AED - MANUAL MODE

(DDU-2400 ONLY)

SELECTING ECG DISPLAY

The DDU-2400 and DDU-2450 allow the user to display the patient ECG when the unit is being used as an AED.

To select ECG display, press the bottom softkey button next to the Mode Select Icon (shown at left) to bring up the Mode of

Operation screen (shown at right).

Press the corresponding softkey (bottom button) to select AED / ECG Mode.

USING THE 3-LEAD ECG MONITORING ADAPTER

The DDU-2400 and DDU-2450 allow the user to perform 3-lead monitoring using the optional ECG Monitoring Adapter (DAC-2020/2021).

To enable ECG Monitor Mode, unplug the deﬁbrillation pads and plug the ECG Monitoring Adapter into the pads connector socket. The AED will automatically switch to ECG Monitor Mode.

To perform a rescue, unplug the ECG Monitoring Adapter and plug in the deﬁbrillation pads.

The ECG Display provides non-diagnostic ECG of the patient’s

WARNING

heart rhythm. It is not intended to provide diagnostic or ST segment interpretation.

AED / Video Mode

Manual Mode

AED / ECG Mode

(with corresponding softkey buttons)

Mode of Operation

Mode of Operation screen

Monitoring

ECG Monitor Mode screen

The DDU-2400 AED provides a Manual Mode to override the AED features of the deﬁbrillator. Manual Mode provides operator-initiated analysis, charge, shock, and disarm functions and is intended for use by qualiﬁed medical personnel trained in advanced life support skills and ECG recognition who want to deliver a shock independent of AED Mode.

The DDU-2400 Manual Mode Charge feature is intended for use

WARNING

SELECTING MANUAL MODE

To select Manual Mode, press the

bottom softkey button next to the Mode Select Icon (shown at left) to bring up the Mode of Operation

screen (shown at right).

Press the corresponding softkey (middle button) to select Manual Mode.

only by authorized operators who have been speciﬁcally trained in cardiac rhythm recognition and in manual deﬁbrillation therapy.

Mode of Operation

AED / Video mode

Manual Mode

AED / ECG Mode

Mode of Operation screen

USING MANUAL MODE

While in Manual Mode, pressing the softkey associated with the icons below allows the user to:

Energy Select: Select the desired energy level (top button).

CHARGE: Initiates a charge (middle button).

DISARM: Cancels a charge (middle button after a charge is initiated).

When charging is complete, press the ﬂashing SHOCK button.

Manual Override

Manual Mode screen

Manual Mode

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For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

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CHECKING AED STATUS ROUTINE MAINTENANCE

ACTIVE STATUS INDICATOR (ASI)

Visually check the Active Status Indicator (ASI) on a daily basis. The ASI should ﬂash green. If the ASI ﬂashes red, is solid red, or if there is no ﬂashing light, the unit requires service. Anytime the ASI ﬂashes red, the unit will also “beep” periodically to call attention to itself.

• Flashing Green: The DDU-2000 Series AED is OFF and

ready for use.

• Solid Green: The DDU-2000 Series AED is ON and ready

for use.

• Flashing or Solid Red: The DDU-2000 Series AED needs

immediate service. Refer to the“Troubleshooting” section

Active Status

Indicator

AED STATUS SCREEN

The AED Status screen is used to provide a quick overview of the DDU-2000 Series AED’s status and to display select information without turning the unit on for a rescue.

With the AED off, press and release the CENTER softkey button to display the AED Status screen. The AED Status screen will be displayed for a short period of time.

If the unit does not turn on at all, check to make sure a good battery pack is installed. (Refer to the “Troubleshooting” section of the User Manual (on Deﬁbtech User CD).

of the User Manual (on Deﬁbtech User CD) or call Deﬁbtech for service.

• No Flashing Light: The DDU-2000 Series AED needs

immediate service. Refer to the “Troubleshooting” section of the User Manual (on Deﬁbtech User CD) or call Deﬁbtech for service.

AED status OK

Battery status Expires 01/2018 Pads status Adult Expires 06/2018 AED S/N 099999999 Battery S/N 099999999 Software version V2.2

AED Status screen

Although the DDU-2000 Series AED is designed to be very low maintenance, simple maintenance tasks must be performed by the owner/operator on a regular basis to ensure the unit’s dependability.

Daily Monthly After Each Use Action

• • •

• •

•

If the unit needs attention, refer to the “Troubleshooting” section of the User Manual (on Deﬁbtech User CD) or call Deﬁbtech for service. For contact information, refer to the “Contacts” section of this guide.

MAINTENANCE MODE

Maintenance Mode permits the user to perform maintenance-related actions such as viewing unit information, initiating unit self-tests, changing unit parameters, downloading rescue data, and upgrading software.

To enter Maintenance Mode press the bottom softkey button to the right of the Tool Icon (shown at left) on

the AED Status screen (for instructions on how to access the AED Status screen, see previous page). To exit Maintenance Mode, simply turn the unit off by pressing the ON/OFF button. For comprehensive information about Maintenance Mode, refer to Chapter 8 of the User Manual (on Deﬁbtech User CD).

Check that the Active Status Indicator is ﬂashing green

Check the condition of the unit and accessories

Run manually initiated self-test

Replace pads

Check pad and battery pack expiration dates

Check the DDC card, if one was installed

AED Main Menu

Rescue now

AED status

AED maintenance

AED options

Rescue options

Help topics

Turn AED off

The display screen during

Maintenance Mode

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For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

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THE DEFIBRILLATION PADS

THE BATTERY PACK

HOW TO CONNECT THE PADS

Insert the connector end of the deﬁbrillation pad cable into the pads connector socket on the top-left corner of the DDU-2000 Series AED as shown. Insert pads connector ﬁrmly until it is fully seated in the unit. The connector will only ﬁt in one way – if the connector does not ﬁt, rotate the connector before trying again.

The connected pads package can then be stored in the pad storage area on the back of the DDU-2000 Series AED (see diagram on page 7).

After connecting the pads connector to the unit, push the pads package, rounded end ﬁrst, 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

ADULT PADS CHILD/INFANT PADS

HOW TO INSERT AND REMOVE THE BATTERY PACK

Before inserting the battery pack into the DDU2000 Series AED, ensure that the battery pack opening in the back of the AED is clean and clear of any foreign objects. Insert the battery pack into the opening in the back of the AED.

Push the pack all the way in until the latch clicks. The battery pack will only ﬁt in one way. If the battery pack does not ﬁt, rotate the battery pack before trying again. Once fully inserted, the battery pack surface should be ﬂush with the back of the AED. Within moments of insertion, the DDU-2000 Series AED will turn on and run a battery pack insertion test. When the test is completed the unit will report the status of the battery pack and shut down. (The battery pack must be removed from the unit for more than 10 seconds for the battery pack self-test to be performed automatically.)

To remove the battery pack, push the battery pack eject release latch. After the battery pack is partially ejected, pull the battery pack out.

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

identiﬁed by their blue connector

and blue pads package)

WHEN TO REPLACE THE PADS

The Deﬁbtech deﬁbrillation 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 Deﬁbtech deﬁbrillation pads.

You may also check the status of the pads when the unit is off by pressing the center softkey button to display the AED Status screen and enter Maintenance Mode.

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WHEN TO REPLACE THE BATTERY PACK

It is important to check the expiration date of the battery pack. The expiration date is printed on the label on the battery pack. The battery pack should be used before the expiration date. When the battery pack is low, the unit will indicate “battery low” or “replace battery now” and the Active Status Indicator will ﬂash red. The battery pack should be replaced immediately. Use only Deﬁbtech battery packs.

You may also check the status of the battery pack when the unit is off by pressing the center softkey button to display the AED Status Screen and enter Maintenance Mode.

For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

Battery Pack

Expiration Date

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DANGERS, WARNINGS, AND CAUTIONS

DANGERS:

Immediate hazards that will result in serious personal injury or death.

• Hazardous electrical output. This equipment is for use

only by qualiﬁed personnel.

• 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-2000 Series 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-2000 Series AED is not to be used in the presence of ﬂammable substance/air mixtures.

WARNINGS:

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

• Improper use can cause injury. Use the DDU-2000

Series AED only as instructed in the User Manual. The DDU-2000 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-2000

Series AED not to function. Maintain the DDU-2000 Series AED only as described in the User Manual. The AED contains no user serviceable parts – do not take the unit apart.

• No modiﬁcation 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 DDU-2000 Series AED. Refer servicing to qualiﬁed service personnel.

• Lithium battery packs are not rechargeable. Any

attempt to recharge a lithium battery pack may result in ﬁre or explosion.

WARNINGS (continued)

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

• Do not let ﬂuids get into the DDU-2000 Series AED. Avoid spilling ﬂuids on the AED or its accessories. Spilling ﬂuids into the DDU-2000 Series AED may damage it or cause a ﬁre or shock hazard.

• Do not sterilize the DDU-2000 Series AED or its accessories.

• Use only Deﬁbtech disposable self-adhesive deﬁbrillation pads, battery packs, and other accessories supplied by Deﬁbtech or its authorized distributors. Substitution of non-Deﬁbtech approved accessories may cause the device to perform improperly.

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

• Do not touch the patient during deﬁbrillation. Deﬁbrillation 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 deﬁbrillation. Disconnect other electrical equipment from the patient before deﬁbrillation.

• Do not shock with deﬁbrillation pads touching each other. Do not shock with gel surface exposed.

• 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.

• 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.

• 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.

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

WARNINGS (continued)

• 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.

• 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-2000 Series AED is recommended.

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

• Handling or transporting the patient in any way 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-2000 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 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.

•

User-initiated and automatic self-tests are designed to assess the DDU-2000 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.

•

The DDU-2400 Manual Mode Charge feature can deliver dangerous energy when used inappropriately; Manual Mode is intended for use by authorized operators who have been speciﬁcally trained in cardiac rhythm recognition and in manual deﬁbrillation therapy.

WARNINGS (continued)

•

Possible misinterpretation of ECG data. The frequency response of the LCD display is intended for basic ECG rhythm identiﬁcation; it does not provide the resolution required for pacemaker pulse identiﬁcation or accurate measurements, such as QRS duration and ST segment interpretation. For such purposes an ECG Monitor with an appropriate frequency response should be used.

•

Follow voice prompts if the LCD screen becomes blank or unreadable.

CAUTIONS:

Conditions, hazards, or unsafe practices that may result in minor personal injury, damage to the DDU-2000 Series AED, or loss of data.

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

• 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).

• 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 pack. Do not crush.

• Use and store the DDU-2000 Series AED only within the range of environmental conditions speciﬁed in the technical speciﬁcations.

• If possible, disconnect the DDU-2000 Series AED from the patient prior to use of other deﬁbrillators.

• Do not connect the DDU-2000 Series to a PC or other device (using the USB port) while the unit’s electrodes are still connected to the patient.

• Using non Deﬁbtech Data Cards (DDC cards) may damage the unit and will void the warranty.

• Although the DDU-2000 Series AED is designed for a wide variety of ﬁeld use conditions, rough handling beyond speciﬁcations may result in damage to the unit.

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For more detailed information, refer to the User Manual (on Deﬁbtech User CD).

Page 12

TECHNICAL SPECIFICATIONS

OPERATING MODES

AED MODE (ALL MODELS) High resolution video display (animated instructions and CPR coaching)

ECG MONITOR MODE (DDU-2400 & 2450 ONLY)

Displays ECG data and event information (with 3-lead electrodes)

DEFIBRILLATOR

TYPE Semi-Automatic external deﬁbrillator

MODEL DDU-2000 Series

WAVEFORM Impedance Compensated Biphasic Truncated Exponential

RESCUE PROTOCOL AHA/ERC 2010 Supports protocol updates by the user (password protected)

ENERGY* AED Mode:

Adult: 150 Joules Child/Infant: 50 Joules

Manual Mode:

Adult: User selectable from 25-200 Joules Child/Infant: User selectable from 25-100 Joules (50 Joules only when using DDP-2002 attenuating pediatric deﬁbrillation pads)

PATIENT ANALYSIS SYSTEM

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

BATTERY PACKS

MODEL DBP-2003 (standard), DBP-2013 (aviation; TSO C-142a)

POWER 12VDC, 2800 mAh

TYPE Lithium/Manganese Dioxide Disposable, recyclable, nonrechargeable

MANUAL MODE (DDU-2400 ONLY)

Displays ECG data and event information and deﬁbrillation energy selection from 25-200 Joules with charge, shock and disarm control

CHARGE TIME AED Mode:

4 seconds or less (from shock advised)**

Manual Mode:

9 seconds or less (150 Joules)*** 12 seconds or less (200 Joules)***

CONTROLS Lighted ON/OFF button Lighted Shock button

DISPLAY High-resolution color LCD

SENSITIVITY/SPECIFICITY Meets AAMI-DF-80 speciﬁcations and AHA recommendations.

CAPACITY* 125 shocks or 8 hours continuous operation

STANDBY LIFE* 4 years

VIDEO PROMPTS Full motion video On-screen text prompts

CPR COACHING Video and voice coaching On-demand video help

VOICE PROMPTS Extensive voice prompts guide user through operation of the unit.

*Nominal into 50 ohm load **Typical, new battery, at 25°C ***Typical, new battery depleted by 6 shocks, at 25°C

LOW BATTERY INDICATIONS

Visible Audible

*Typical, new battery, at 25°C

DEFIBRILLATION / MONITORING PADS

MODEL Adult – DDP-2001 Child/Infant – DDP-2002 and DDP-2003

SURFACE AREA Adult – 77cm2 (nominal, each pad) Child/Infant – 50cm2 (nominal, each pad)

EVENT DOCUMENTATION

INTERNAL EVENT RECORD Critical ECG segments and rescue event parameters are recorded (greater than 60 minutes) and can be downloaded to a removable data card.

PC-BASED EVENT REVIEW ECG with event tag display, and audio playback when available.

REMOVABLE STORAGE (optional) Up to 30 hours of ECG and event data storage (no audio option) or up to 3 hours of audio (audio option).

ENVIRONMENTAL

TEMPERATURE Operating: 0 to 50°C (32 to 122°F) Standby: 0 to 50°C (32 to 122°F)

RELATIVE HUMIDITY Operating/Standby: 5%-95% (non-condensing)

ALTITUDE

-500 to 15,000ft (-150 to 4500m) per MIL-STD-810F 500.4 Procedure ll

VIBRATION Ground (MIL-STD-810F 514.5 Category 20)

Helicopter (RTCA/DO-160D, Section 8.8.2, Cat R. Zone 2, Curve G)

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

SHOCK/DROP ABUSE TOLERANCE

MIL-STD-810F 516.5 Procedure IV 48 inches (1.2 meters), any edge, corner, or surface, in standby mode

CRUSH TEST 1,000 pounds (450kg)

SEALING/WATER RESISTANCE

IEC 60529 class IP55; Dust protected, Protected against water jets (battery pack installed)

TYPE Pre-connected, single-use, non-polarized, disposable, self-adhesive electrodes with cable and connector

ECG and event storage on a removable data card. Actual length of storage is dependent on card capacity.

USB PORT Event download and maintenance operations.

ESD IEC 61000-4-2: (Open air up to 15kV or direct contact up to 8kV)

EMC (Emission) CISPR 11 Group 1 Level B and FCC Part 15

EMC (Immunity) IEC 61000-4-3 and IEC 61000-4-8

AIRCRAFT Meets RTCA/DO-160G, Section 21, RF Radiated Emissions, Category M

SELF-TESTS

AUTOMATIC Automatic daily, weekly, monthly and quarterly circuitry tests

BATTERY INSERTION System integrity test on battery insertion

PAD PRESENCE Pads preconnected tested daily

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

STATUS INDICATION Visual and audible indication of unit status

STATUS SCREEN Unit self-tests results Pads and battery information (status and expiration)

PHYSICAL

SIZE

7.3 x 9.5 x 2.3 inches (18.5 x 24 x 5.8 cm)

WEIGHT Less than 3 lbs (1.4kg) (with battery)

0197

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DAC-E25 30EN- BC DAC-E25 30EN- BC

Speciﬁcations subject to change without notice

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WARRANTY INFORMATION CONTACTS

ORIGINAL END USER’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 WARRANTY LI MITATIONS

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 WARRANTY 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.

*Applicable to deﬁbrillators and associ ated accessories

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

EXC LUS IVE RE ME DY

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 SERVICE

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 WARRANTY 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.

Manufacturer

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

Tel.: 1-(866) 333-4241 (Toll-free within North America) 1-(203) 453-4507 Fax: 1-(203) 453-6657

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

Patents pending.

This product and its accessories are manufactured and sold under one or more of the following United States patents: D523,393, D548,346, D551,628.

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.

European Authorized Representative

EC REP

Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands

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NOTES

DAC-E25 30EN- BC