Defibtech DDU-2200 Manual de usuario

DAC-E2532EN-BB

Deﬁbtech DDU-2200

Fully-Automatic

External Deﬁbrillator

Operating Guide

For concise guidance on

set-up, use, maintenance

and technical speciﬁcations

ELECTRONIC

DISTRIBUTION

DAC-E2532EN-BB

DAC-E2532EN-BB (Issued: 2020-01-27)

Notices

Deﬁbtech, L.L.C. 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.

For more detailed information regarding the Deﬁbtech DDU-2200 AED, please refer to

the User Manual at www.deﬁbtech.com.

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.

information, refer to the “Contacts” section of this guide.

Tracking

U.S.A. federal regulations require Deﬁbtech to maintain records for each AED it

distributes (reference 21 CFR 821, Medical DeviceTracking). 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

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 visit www.deﬁbtech.com/register.

Federal Law (USA) restricts this

device to sale by or on the order

of a physician.

CAUTION

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

use, maintenance and technical speciﬁcations on the DDU-2200 AED.

For comprehensive training on set-up, use and maintenance

as well as complete technical speciﬁcations,

refer to the User Manual at www.deﬁbtech.com

Contents

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

When to Use (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 Data Card (optional)....................................................16

Checking AED Status .......................................................................17

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

Troubleshooting............................................................................... 22

Warnings and Cautions....................................................................24

Technical Speciﬁcations ................................................................. 26

Glossary of Symbols ....................................................................... 30

Warranty Information...................................................................... 33

Contacts............................................................................................ 34

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

QUICK USE INSTRUCTIONS WHEN TO USE

PRESS “ON”

BUTTON

APPLY PADS

FOLLOW AED

INSTRUCTIONS

INDICATIONS

The DDU-2200 Automated External Deﬁbrillator (AED) is indicated for use on

victims of sudden cardiac arrest (SCA) who are:

• Unconscious and unresponsive

• Not breathing or not breathing normally

For patients under 8 years old, or weighing less than 55 lbs (25 kg), use child/

infant deﬁbrillation pads, if available. Do not delay therapy to determine exact age

or weight. Apply the pads as shown for a child/infant and use the AED.

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

CONTRAINDICATIONS

None.

OPERATOR TRAINING REQUIREMENTS

In order to safely and effectively operate the DDU-2200 AED, a person shall have

met the following requirements:

• Deﬁbtech DDU-2200 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 the

User Manual (available for viewing/download at www.deﬁbtech.com).

Refer to User Manual Section 9.1.6 for Summary of Primary Clinical Studies and

User Manual Section 9.1.7 for Potential Adverse Effects of the Device on Health.

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

DIAGRAM OF COMPONENTS

DEFIBRILLATION

PADS PACKAGE

BATTERY PACK

BACK OF AED

Pads

Connector

Deﬁbrillation Pads

Expiration Date

(on back of package)

Deﬁbrillation Pads

(inside of package)

Battery Pack Opening Battery Pack

Eject Release

Latch

Pad Storage Area

Active Status Indicator (ASI) –

Indicates the current status of the AED

Softkey Buttons

(Top, Center, Bottom) –

Buttons used to navigate

menus or select options

Pads Connector Socket –

Socket for pads connector

USB and Deﬁbtech

Data Card (DDC Card)

Access Door –Access to the

USB connector port and

Deﬁbtech Data Card slot

Display Screen –

Displays video,

text prompts

and information

Speaker

Deﬁbtech

Data Card

(DDC Card)

(optional)

USB Port

FRONT OF AED

OPERATING GUIDE

(For more detailed information,

refer to the User Manual

at www.deﬁbtech.com)

Deﬁbtech DDU-2200

Fully-Automatic

External Deﬁbrillator

Operating Guide

ON/OFF Button –

Turns AED on and off

SHOCK Required

Indicator –

Flashes when a

shock is advised, the

unit has charged, and

is about to deliver a

shock.

Do not touch the

patient while this

indicator is ﬂashing.

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

SETTING UP THE AED

CONNECT

THE PADS TO

THE AED

INSTALL THE

BATTERY PACK

CHECK THE

STATUS

READ THE

USER MANUAL

(at www.deﬁbtech.com)

Comprehensive information about the

DDU-2200 AED can be found in the

User Manual (at www.deﬁbtech.com).

The DDU-2200 AED is designed to be stored in a “ready” state

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

XXXX

YYYY

Check pads expiration date before connecting to

AED as shown. Record pads expiration date for

future reference.

For more pads information, refer to page 14.

XXX-XXXX -XX

YYYY-MM-DD

KMMDDYY-NN

(01) XXXXXXXXXXXXXX

(17) XXXXXX

(10) XXXXXXX-XX

LOT

REF

XXX-XXXX -XX

YYYY-MM-DD

KMMDDYY-NN

(01) XXXXXXXXXXXXXX

(17) XXXXXX

(10) XXXXXXX-XX

LOT

REF

XXX-XXXX -XX

YYYY-MM-DD

KMMDDYY-NN

(01) XXXXXXXXXXXXXX

(17) XXXXXX

(10) XXXXXXX-XX

LOT

REF

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 battery pack information, refer to page 15.

XXXX

YYYY

Check battery pack expiration date as shown. Record

battery pack expiration date for future reference.

MADEIN USA

PATENTSPENDING

YYYY-MM-DD

DBP-2003

BATTERYPACK

741 Boston Post Road, Suite 201

Guilford, CT 06437 USA

ELS-LP120-402

XXXXXXXXX

(01)XXXXXXXXXXXXXX

(17)XXXXXX

(21)XXXXXXXXX

MADEIN USA

PATENTSPENDING

YYYY-MM-DD

DBP-2003

BATTERYPACK

741 Boston Post Road, Suite 201

Guilford, CT 06437 USA

ELS-LP120-402

XXX XXXXX X

(01)XXXXXXXXXXXXXX

(17)XXXXXX

(21)XXXXXXXXX

DBP-1400

DBP-L006-004

0°C/

32°F

50°C/

122°F

YYYY-MM-DD

XXXXXXXXX

(01)XXXXXXXXXXXXXX

(17)XXXXXX

(21)XXXXXXXXX

741 Boston Post Road, Suite 201

Guilford, CT 06437 USA

patents - www.deﬁbtech.com/patents

NON-RECHARGEABLE

BATTERY PACK

For more information, refer to page 17.

With the AED off, press and release the CENTER

softkey button (as indicated by the arrow above). Ensure

that the AED Status screen appears as shown above

and that the “AED Status” is “OK”.

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.

AED status OK

Battery status

Expires 01/20xx

Pads status Adult

Expires 06/20xx

AED S/N 099999999

Battery S/N 099999999

Software version Vx.x

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

USING THE AED

TURN

AED ON

PREPARE

THE PATIENT

Press “ON/OFF” button to turn AED on.

Follow the voice and onscreen instructions.

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

hold the ON/OFF button for approximately 2 seconds.)

Remove clothing from patient’s chest.

If necessary, dry chest and remove excess chest hair.

PREPARE

PADS*

PLACE

PADS

Apply pads to patient’s bare chest.

For more information, refer to page 14.

ADU LT

PATIENT

CHILD/INFANT

PATIENT

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.

If the patient is unconscious or unresponsive, and is

not breathing or not breathing normally, ensure emergency

medical assistance has been called and start using the AED.

Peel adhesive pads

from blue liner.

Tear open

pads package.

*NOTE: If the patient is an infant or child under 8 years or

less than 55 pounds (25 kg) and pediatric deﬁbrillation pads

are available, disconnect the adult pads connected to the AED

and connect the pediatric pads (see step 1 in the “Setting Up

the AED” section on page 8 for details). Do not delay therapy

to determine exact age or weight. If pediatric pads are not

available, apply adult pads in the position as shown in

step 4 below for a child/infant and use the AED.

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

USING THE AED (continued)

STAND CLEAR

IF SHOCK

REQUIRED

INDICATOR

FLASHES,

DO NOT TOUCH

THE PATIENT

When instructed, do not touch the patient.

PERFORM CPR

CONTINUE

TO FOLLOW

INSTRUCTIONS

Follow instructions to perform CPR, if needed.

Continue to follow the voice

and onscreen 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.

If the DDU-2200 AED determines that a shock

is required, the unit will indicate this by

a vocal announcement and by ﬂashing the

Shock Required Indicator for 5 seconds.

After completing charge-up, the unit will shock the

patient automatically, without any user intervention.

Do not touch the patient while the

Shock Required Indicator is ﬂashing.

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

THE DEFIBRILLATION PADS THE BATTERY PACK

HOW TO INSERT AND

REMOVE THE BATTERY PACK

Before inserting the battery pack into the DDU-

2200 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-2200 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. (Note: The battery

pack must have been removed from the unit for

at least 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.

WHEN TO REPLACE THE BATTERY PACK

It is important to check the expiration date of 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 check the status of the battery pack

when the unit is off by pressing the center

softkey button to display the AED Status Screen.

The expiration date is also printed on the label on

the battery pack as shown at right.

Battery Pack Label

Located Here

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-2200 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 should be stored in the pad storage area on

the back of the DDU-2200 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.

Note: Deﬁbtech recommends that the AED be stored with adult deﬁbrillation pads connect-

ed to the unit and that a set of pediatric deﬁbrillation pads be stored in an accessible location

near the AED (e.g. in an AED storage case), but not connected to the unit.

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. Do not use pads past their expiration

date. Discard expired pads. Use only Deﬁbtech deﬁbrillation pads.

You may check the status of the pads when the unit is off by pressing the center softkey

button to display the AED Status screen.

The expiration date is also printed on the outside of the sealed package.

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)

ADULT PADS CHILD/INFANT PADS

WHICH PADS TO USE

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

THE DEFIBTECH DATA CARD (OPTIONAL) CHECKING AED STATUS

• Flashing Green: The DDU-2200 AED is OFF and ready for

use.

• Solid Green: The DDU-2200 AED is ON and ready for use.

• Flashing or Solid Red: The DDU-2200 AED needs

immediate service. Refer to“Troubleshooting” on page 22 or

call Deﬁbtech for service.

• No Flashing Light: The DDU-2200 AED needs immediate

service. Refer to“Troubleshooting” on page 22 or call

Deﬁbtech for service.

Active

Status

Indicator

ACTIVE STATUS INDICATOR (ASI)

The Active Status Indicator (ASI) should be visually checked on a regular basis to ensure that

the AED is ready for use. The ASI should ﬂash green. If the ASI ﬂashes red, is solid red, or if

there is no ﬂashing light, the unit requires service. The unit will also “beep” periodically to

call attention to itself when the ASI is ﬂashing red.

AED STATUS SCREEN

The AED Status screen is used to provide a

quick overview of the DDU-2200 AED’s sta-

tus 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

brieﬂy be displayed.

If the unit does not turn on at all, check to

make sure a good battery pack is installed

(refer to “Troubleshooting” on page 22).

AED Status screen

AED status OK

Battery status

Expires 01/20xx

Pads status Adult

Expires 06/20xx

AED S/N 099999999

Battery S/N 099999999

Software version Vx.x

HOW TO INSERT AND REMOVE THE DEFIBTECH DATA CARD

The optional Deﬁbtech Data Card (DDC card) is used to store event and audio information

collected by the AED. All DDU-2200 AEDs will operate without DDC cards and will still store

select event information internally. Information stored on the DDC card is retrievable with a

separate Deﬁbtech PC-based software package. (Refer to the “DeﬁbView” section of the

DDU-2200 User Manual available at www.deﬁbtech.com.)

Before installing the DDC card, ensure the AED is turned OFF.

Locate the data card/USB port access door on the right-hand

side of the unit. Open the data card/USB port access door

by slightly pushing and then sliding the door down to release

the latch. The door will spring open. Insert the DDC card into

the thin slot in the side of the AED centered above the USB

port opening, notched end ﬁrst, label side up, until it clicks

into place. The card should 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 card, press the card as far as it will go and then release. Upon release,

the DDC card will be partially ejected and can be removed by pulling the DDC card the rest

of the way out.

Close the data card/USB port access door by closing and then pushing the door up until the

door latch engages.

EVENT DATA

As part of Deﬁbtech’s on-going regulatory compliance activities, event data shared with

Deﬁbtech may be used by Deﬁbtech to fulﬁll regulatory obligations. Any identifying personal

data or health information received is considered conﬁdential within Deﬁbtech and will not be

used for any other purpose. Please contact Deﬁbtech at support@deﬁbtech.com should there

be any further questions.

XX XX XX

CAUTION

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

unit and will void the warranty.

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

MAINTENANCE

ROUTINE MAINTENANCE

The DDU-2200 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 environ-

ment 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 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

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 22 or call Deﬁbtech for service. For contact information, refer

to the “Contacts” section on page 34.

SAMPLE

Check the condition of the unit and accessories

SAMPLE

Check the condition of the unit and accessories

Run manually-initiated self-test

SAMPLE

Run manually-initiated self-test

Replace pads

SAMPLE

Replace pads

Check pad and battery pack expiration dates

SAMPLE

Check pad and battery pack expiration dates

Check the DDC card, if one was installed

SAMPLE

Check the DDC card, if one was installed

MAINTENANCE MODE (AED Main Menu)

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). The AED Main Menu will now be displayed,

as shown at right. If the AED is needed to perform

a rescue while in Maintenance Mode, navigate to

and select the “Rescue now” menu option.

AED Main Menu screen

(Maintenance Mode)

Rescue now

AED status

AED maintenance

AED options

Rescue options

Help topics

Turn AED off

AED Main Menu

MAINTENANCE MODE (AED Maintenance)

The AED Maintenance screen allows the user to select

such options as AED tests, software upgrades, data

backups, and data card functions.

For detailed information about each of the functions

that can be accessed from this screen,

refer to the

DDU-2200 User Manual, which can be viewed at or

downloaded from www.deﬁbtech.com.

MAINTENANCE MODE (Help Topics)

The Help Topics screen provides a list of available videos

that detail various aspects of using and maintaining the

DDU-2200 AED.

To exit Maintenance Mode, turn the unit off by pressing

the ON/OFF button or navigate to the AED Status Screen

by selecting the “Go to main menu” option and then

navigate to and select the “Turn AED off” option.

MAINTENANCE MODE (AED Options)

The AED Options screen allows the user to manually

conﬁgure AED options such as time, date, volume, and

audio recording.

For detailed information about each of the functions

that can be accessed from this screen,

refer to the

DDU-2200 User Manual, which can be viewed at or

downloaded from www.deﬁbtech.com.

MAINTENANCE MODE (Rescue Options)

The Rescue Options screen allows the user to manually

conﬁgure rescue options such as rescue protocol and

CPR breathing.

For detailed information about the functions that can

be accessed from this screen,

refer to the DDU-2200

User Manual at www.deﬁbtech.com.

Rescue now

Perform AED test

Upgrade AED

Transfer data to card

Format data card

Run application from card

Go to main menu

AED Maintenance

Rescue now

Preparing the patient

Analyzing and shocking

Performing CPR

Replacing the battery

Replacing the pads

Checking the AED status

Replacing the data card

Go to main menu

Help Topics

Rescue now

System time hh:mm:ss

System date yyyy mm dd

Volume level High

Audio recording Disabled

Status broadcast Disabled

Go to main menu

AED Options

Rescue now

CPR breathing Disabled

Rescue protocol AHA

Settings

1 / 2 / 30 / 50 / 100

Go to main menu

Rescue Options

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