Defibtech DDU-2300 Manual de usuario

DAC-2513EN-AB

Deﬁbtech DDU-2300

Semi-Automatic

External Deﬁbrillator

User Manual

PRESS “ON”

BUTTON

APPLY PADS

FOLLOW AED

INSTRUCTIONS

IF INSTRUCTED,

PRESS“SHOCK”

BUTTON

DAC-2513EN-AB

iii

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.

Chapter 12 of this manual.

Federal Law (USA) restricts this device

to sale by or on the order of a physician.

CAUTION

DANGER

WARNING

DAC-2513EN-AB

Contents

1 Introduction To The DDU-2300 AED ........................................................... 1-1

Overview ............................................................................................................................1-1

The Deﬁbtech DDU-2300 AED ...........................................................................................1-2

Indications...........................................................................................................................1-4

Contraindications ................................................................................................................1-4

Operator Training Requirements.........................................................................................1-4

2 Dangers, Warnings, And Cautions............................................................... 2-1

Dangers ..............................................................................................................................2-1

Warnings.............................................................................................................................2-1

Cautions.............................................................................................................................. 2-2

3 Setting Up The DDU-2300 AED................................................................... 3-1

Overview ............................................................................................................................3-1

Connecting The Pads.......................................................................................................... 3-1

Installing The Deﬁbtech Data Card (DDC card) (Optional) ..................................................3-2

Installing And Removing the Battery Pack..........................................................................3-3

Checking The DDU-2300 AED Status................................................................................. 3-3

Completing The Installation ................................................................................................3-4

Storing The DDU-2300 AED ............................................................................................... 3-4

4 Using The DDU-2300 AED In Rescue Mode................................................. 4-1

Overview ............................................................................................................................4-1

Preparation..........................................................................................................................4-2

Heart Rhythm Analysis .......................................................................................................4-5

Delivering The Shock ..........................................................................................................4-5

CPR Period..........................................................................................................................4-5

Post Use Procedures ..........................................................................................................4-6

Rescue Mode Voice And Text Prompts ..............................................................................4-6

Operational Environment ..................................................................................................4-10

5 Maintenance And Troubleshooting ............................................................. 5-1

Routine Unit Maintenance ..................................................................................................5-1

Self-Tests ............................................................................................................................5-5

Cleaning ..............................................................................................................................5-5

Storage ...............................................................................................................................5-5

Operator’s Checklist............................................................................................................ 5-6

Troubleshooting ..................................................................................................................5-7

Repair..................................................................................................................................5-8

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See page references noted in green throughout this book for other interactive links.

DAC-2513EN-AB

6 Maintenance Mode ...................................................................................... 6-1

Overview ............................................................................................................................6-1

Navigation (in Maintenance Mode) .....................................................................................6-1

Entering Maintenance Mode ..............................................................................................6-2

AED Main Menu Screen .....................................................................................................6-2

AED Status Screen .............................................................................................................6-2

AED Maintenance Screen...................................................................................................6-3

AED Options Screen........................................................................................................... 6-5

Rescue Options Screen ......................................................................................................6-7

Help Topics Screen .............................................................................................................6-9

7 DDU-2300 AED Accessories........................................................................ 7-1

Deﬁbrillation Pads ...............................................................................................................7-1

Battery Packs...................................................................................................................... 7-1

Data Cards ..........................................................................................................................7-1

USB Cable...........................................................................................................................7-1

8 Event Viewing ............................................................................................. 8-1

DeﬁbView II ........................................................................................................................ 8-1

Deﬁbtech Data Cards (DDC cards) .................................................................................... 8-1

Downloading The Internal Data Log ...................................................................................8-1

9 Technical Speciﬁcations.............................................................................. 9-1

Deﬁbtech DDU-2300 AED ..................................................................................................9-1

Battery Packs...................................................................................................................... 9-5

Self-Adhesive Deﬁbrillation Pads ........................................................................................9-5

Event Documentation .........................................................................................................9-6

Deﬁbtech Event Viewer...................................................................................................... 9-6

Recycling Information .........................................................................................................9-6

Notice To European Union Customers ............................................................................... 9-6

10 Electromagnetic Conformity ..................................................................... 10-1

Guidance And Manufacturer’s Declaration........................................................................ 10-1

11 Glossary Of Symbols ................................................................................. 11-1

12 Contacts .................................................................................................... 12-1

Click any of the section headings above to be automatically re-directed to that page.

See page references noted in green throughout this book for other interactive links.

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1-1

1. Introduction

1 Introduction To The DDU-2300 AED

This User Manual provides information to guide trained operators in the use and maintenance of the Deﬁbtech

DDU-2300 Semi-Automatic External Deﬁbrillator (“AED”) and its accessories. The DDU-2300 refers to all AEDs in the

DDU-2300 series of AEDs.

This chapter includes intended use, an overview of the AED, a discussion of when it should and should not be used,

and information on operator training.

Overview

The DDU-2300 AED is a Semi-Automatic External Deﬁbrillator (“AED”) that is designed to be easy to use, portable,

and battery powered. It has two primary user controls: the ON/OFF and SHOCK buttons. Voice prompts, text

prompts, and a display screen with visual prompts provide a simple interface for the operator. The DDU-2300

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-2300 AED performs the following tasks:

• Prompts the operator, through audio, text, and video prompts, to prepare the patient for treatment.

• Automatically analyzes the patient’s ECG.

• Determines whether a shockable rhythm is present.

• Charges the debrillation 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.

• Provides instructions to perform CPR.

• Repeats the process if additional shocks are required.

The Deﬁbtech 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-2300 AED uses two self-adhesive deﬁbrillation pads (also known as electrode pads, electrodes, monitoring

pads, or pads) to monitor ECG signals and, if necessary, to deliver deﬁbrillation energy to the patient. These pads

are provided in a single-use, disposable package. The DDU-2300 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).

The DDU-2300 AED user interface is clear and concise. It has two primary push-button controls and a display screen.

Easily understandable voice messages and text and video prompts guide the operator through the use of the unit.

The device communicates the status of the AED and of the patient to the operator.

Deﬁbrillation energy is delivered as an impedance compensated biphasic truncated exponential waveform. The

device delivers 150 Joules of deﬁbrillation energy (into a 50-ohm load) when using adult pads and 50J of deﬁbrillation

energy (into a 50-ohm load) when using attenuated child/infant pads (also known as pediatric pads). Energy delivered

does not change signiﬁcantly with patient impedance, although the duration of the generated waveform will vary.

Deﬁbrillation and AED operating power is supplied by a replaceable (non-rechargeable) battery pack that provides

for long standby life and low maintenance operation. Battery packs are available in several congurations optimized

for use in speciﬁc applications. Each battery pack is marked with an expiration date.

The DDU-2300 AED records event documentation internally and, optionally, on Deﬁbtech Data Cards (“DDC cards”).

The optional DDC card plugs into a slot in the AED and enables the AED to record event documentation and, optionally,

audio data onto the card. Audio recording is selectable through conﬁguration settings. Event documentation stored

internally can be downloaded onto a DDC card for review.

A USB port is provided to perform maintenance and data recovery. The USB interface allows connection to a personal

computer. Deﬁbtech PC maintenance software helps support event downloading and unit maintenance operations.

AW-102

D. ON/OFF Button

C. Display Screen

E. Pads Connector Socket

F. Active Status Indicator (ASI)

B. SHOCK Button

G. Softkey Buttons

(Top, Center, Bottom)

H. USB Port

I. Defibtech Data Card

(DDC Card) (optional)

J. USB and Defibtech Data Card

(DDC Card) Access Door

N. Pad Storage Area

A. Speaker

L. Battery Pack Opening

K. Unit Serial Number

M. Battery Pack

Eject Release Latch

R. Battery Pack

Serial Number

S. Battery Pack

Q. Defibrillation Pads

Expiration Date

(on back of package)

T. Battery Pack

Expiration Date

P. Defibrillation

Pads

O. Pads Connector

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1-2

DAC-2513EN-AB

1-3

FRONT OF AED

DEFIBRILLATION

PADS PACKAGE

BATTERY PACK

BACK OF AED

1. Introduction

A. Speaker. The speaker projects the voice

prompts when the DDU-2300 AED is on.

The speaker also emits a “beep” when the

unit is off and has detected a condition that

requires attention from the user or needs

servicing.

B. SHOCK Button. This button will ﬂash

when a shock is recommended. Pressing

this button will deliver a shock when the

button is ﬂashing. This button is disabled at

all other times.

C. Display Screen. Color display panel

used to display text and video prompts,

messages, indicators for rescue, unit status,

and maintenance operations. The display

screen provides visual prompts, including

CPR coaching, to assist rescuers with

step-by-step instruction.

D. ON/OFF Button. This button is used to turn

the DDU-2300 AED on and off.

E. Pads Connector Socket. The Pads

Connector (item O) is inserted into

this socket.

F. Active Status Indicator (ASI). The ASI

indicates the current status of the AED.

This indicator ﬂashes green to indicate the

unit is ready for use and ﬂashes red to

indicate unit needs attention from the

user or needs servicing.

G. Softkey Buttons. Three context

sensitive softkey buttons are used to

navigate menus or select actions.

H. USB Port. The USB port is provided to

perform data recovery and maintenance.

Not to be used during rescue operation.

I. Deﬁbtech Data Card (DDC card). This

optional plug-in card provides enhanced

storage capabilities to the DDU-2300 AED.

J. USB and Deﬁbtech Data Card (DDC card)

Access Door. Behind the access door is the

USB connector port and Deﬁbtech Data Card

(DDC card) slot.

K. Unit Serial Number. The unit’s serial

number can be found on the back of the

AED, above the battery pack opening.

L. Battery Pack Opening. This opening is

where the battery pack is inserted into the

unit.

M. Battery Pack Eject Release Latch.

This release latch releases the battery pack

from the DDU-2300 AED.

N. Pad Storage Area. The pad storage area

is found on the back of the AED allowing the

pads to be stored in a pre-connected state

for rapid deployment during an emergency.

O. Pads Connector. This connector attaches

the patient pads to the unit at the Pads

Connector Socket (item E).

P. Deﬁbrillation Pads. The deﬁbrillation

pads are pads that are placed on the patient.

The pads may be stored in the pad storage

area on the back of the unit.

Q. Deﬁbrillation Pads Expiration Date (back

side).The deﬁbrillation pads expiration date

is located on the back side of the pads

package. Do not use the pads after the

printed date has passed.

R. Battery Pack Serial Number.The battery

pack’s serial number is located on the label on

the battery pack.

S. Battery Pack. The battery pack provides a

replaceable main power source for the

DDU-2300 AED.

T. Battery Pack Expiration Date.The battery

pack expiration date is printed on the label on

the battery pack. Do not use the battery

pack after the printed date has past.

The Deﬁbtech DDU-2300 AED

DAC-2513EN-AB

1-4

Indications

The DDU-2300 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.

The DDU-2300 AED must be used by or on the order of a physician.

Contraindications

The DDU-2300 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 DDU-2300 AED, a person shall have met the following requirements:

• DDU-2300 AED and/or debrillation 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.

1. Introduction

DAC-2513EN-AB

2-1

2. Dangers, Warnings,

And Cautions

2 Dangers, Warnings, And Cautions

This chapter includes a list of danger, warning, and caution messages that relate to the Deﬁbtech DDU-2300 AED and

its accessories. Many of these messages are repeated elsewhere in this User Manual and on the DDU-2300 AED or

accessories. The entire list is presented here for convenience.

CAUTION

DANGER

WARNING

DANGERS:

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

• Hazardous electrical output. This equipment is for use only by qualied personnel.

• The DDU-2300 AED is not suitable for use in the presence of a ammable anesthetic mixture.

• Not suitable for use in oxygen enriched atmosphere.

• The DDU-2300 AED has not been evaluated or approved for use in hazardous locations as dened in the National

Electric Code standard. In compliance with IEC classiﬁcation, the DDU-2300 AED is not to be used in the presence

of ﬂammable substance/air mixtures.

CAUTION

DANGER

WARNING

WARNINGS:

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

• Improper use can cause injury. Use the DDU-2300 AED only as instructed in the User Manual. The DDU-2300 AED

delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly.

• Improper maintenance can cause the DDU-2300 AED not to function. Maintain the DDU-2300 AED only as described

in the User Manual. The AED contains no user serviceable parts – do not take the unit apart.

• 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-2300 AED. Refer servicing to qualiﬁed

service personnel.

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

• Do not immerse battery pack in water or other liquids. Immersion in uids may result in re or explosion.

• Do not let uids get into the DDU-2300 AED. Avoid spilling uids on the AED or its accessories. Spilling uids into

the DDU-2300 AED may damage it or cause a re or shock hazard.

• Do not sterilize the DDU-2300 AED or its accessories.

• Use only Debtech disposable self-adhesive debrillation pads, battery packs, and other accessories supplied by

Debtech or its authorized distributors. Substitution of non-Debtech 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 debrillation. Debrillation current can cause operator or bystander injury.

• Do not allow pads to touch metal objects or equipment in contact with the patient. Do not touch equipment connected

to the patient during deﬁbrillation. Disconnect other electrical equipment from the patient before deﬁbrillation.

• Do not shock with debrillation pads touching each other. Do not shock with gel surface exposed.

• Do not allow debrillation pads to touch each other, or to touch other ECG electrodes, lead wires, dressings,

transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during deﬁbrillation and

may divert deﬁbrillating energy away from the heart.

• The debrillation pads are intended for one time use only and must be discarded after use. Reuse can lead to

potential cross infection, improper performance of the device, inadequate delivery of therapy and/or injury to the

patient or operator.

• Avoid contact between parts of the patient’s body and conductive uids such as water, gel, blood or saline, and metal

objects, which may provide unwanted pathways for deﬁbrillating current.

DAC-2513EN-AB

2-2

• Disconnect all non-debrillator proof equipment from the patient before debrillation to prevent electrical shock haz-

ard and potential damage to that equipment.

• Aggressive or prolonged CPR to a patient with debrillation 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-2300 AED is recommended.

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

• 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.

• In patients with cardiac pacemakers, the DDU-2300 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 debrillation, air pockets between the skin and debrillation 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-2300 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.

CAUTION

DANGER

WARNING

CAUTIONS:

Conditions, hazards, or unsafe practices that may result in minor

personal injury, damage to the DDU-2300 AED, or loss of data.

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

• Follow all debrillation pad label instructions. Use debrillation 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 federal, state, and/or local laws. To avoid re and

explosion hazard, do not burn or incinerate the battery pack. Do not crush.

• Use and store the DDU-2300 AED only within the range of environmental conditions specied in the technical

speciﬁcations.

• If possible, disconnect the DDU-2300 AED from the patient prior to use of other debrillators.

• Do not connect the DDU-2300 to a PC or other device (using the USB port) while the unit’s electrodes are still

connected to the patient.

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

• Although the DDU-2300 AED is designed for a wide variety of eld use conditions, rough handling beyond specications

may result in damage to the unit.

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

2. Dangers, Warnings,

And Cautions

WARNINGS (continued)

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