Defibtech DDU-2400 User Manual

Defibtech DDU-2400 User Manual

Automated external defibrillator
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Defibtech DDU-2000 Series
Automated External Defibrillator
• DDU-2300
• DDU-2400
• DDU-2450
User Manual
DAC-E2510EN-BA
ELECTRONIC
AHA / ERC 2010
DISTRIBUTION

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Summary of Contents for Defibtech DDU-2400

  • Page 1 Defibtech DDU-2000 Series Automated External Defibrillator • DDU-2300 • DDU-2400 • DDU-2450 User Manual DAC-E2510EN-BA ELECTRONIC AHA / ERC 2010 DISTRIBUTION...
  • Page 2 PRESS “ON” BUTTON APPLY PADS FOLLOW AED INSTRUCTIONS IF INSTRUCTED, PRESS“SHOCK” BUTTON DAC-E2510EN-BA...
  • Page 3 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.
  • Page 4: Table Of Contents

    3.1 Overview ......................... 13 3.2 Connecting The Defibrillation Pads .................. 13 3.3 Installing The Defibtech Data Card (DDC Card) (Optional) ..........14 3.4 Installing And Removing The Battery Pack ..............15 3.5 Checking The DDU-2000 Series AED Status ..............15 3.6 Completing The Installation .....................
  • Page 5 9.4 USB Cable ........................50 9.5 ECG Monitoring Adapter ....................50 Event Viewing ....................51 10.1 Defibview ........................51 10.2 Defibtech Data Cards (DDC Cards) ................51 10.3 Downloading The Internal Data Log ................51 Technical Specifications ..................52 11.1 Defibtech DDU-2000 Series AED ..................52 11.2 Battery Packs ........................
  • Page 6: Introduction To The Ddu-2000 Series Aed

    • Allows user to select between Video display or ECG display (DDU-2400 and DDU-2450 only). In ECG Monitor Mode (DDU-2400 and DDU-2450 only), the AED allows display of the patient ECG using an optional 3-wire (LEAD II) ECG adapter cable. ECG Monitor Mode provides a non-diagnostic display of the heart rhythm of a responsive or breathing patient for attended patient monitoring.
  • Page 7 50 J of defibrillation energy (into a 50-ohm load) when using child/infant pads (also known as pediatric defibrillation pads). Energy delivered does not change significantly with patient impedance, although the duration of the generated waveform will vary. In Manual Mode, the DDU-2400 (only) offers user-selected energy levels from 25 to 200 Joules.
  • Page 8: The Defibtech Ddu-2000 Series Aed

    This optional plug-in card provides enhanced storage capabilities to the AED. U. ECG Monitoring Adapter. This optional adapter for the DDU-2400 and J. USB and Defibtech Data Card (DDC card) the DDU-2450 provides a non-diagnostic Access Door. Behind the access door is the ECG display of the patient’s heart rhythm...
  • Page 9 B. SHOCK Button H. USB Port A. Speaker I. Defibtech Data Card (DDC Card) (optional) J. USB and Defibtech Data Card (DDC Card) Access Door FRONT OF AED U. ECG Monitoring Adapter (optional; DDU-2400/2450 only) K. Unit Serial Number L. Battery Pack Opening M.
  • Page 10: Indications

    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 physician-authorized emergency medical training. Users should be trained in ECG recognition to allow for rhythm and heart rate monitoring using standard ECG monitoring electrodes.
  • Page 11: Dangers, Warnings, And Cautions

    Dangers, Warnings, And Cautions This chapter includes a list of danger, warning, and caution messages that relate to the Defibtech DDU-2000 Series AED and its accessories. Many of these messages are repeated elsewhere in this User Manual and on the DDU-2000 Series AED or accessories.
  • Page 12: Cautions

    • 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 only by authorized operators who have been specifically trained in cardiac rhythm recognition and in manual defibrillation therapy.
  • Page 13: Setting Up The Ddu-2000 Series Aed

    Setting Up The DDU-2000 Series AED This chapter describes the steps required to make your Defibtech DDU-2000 Series AED operational. The DDU-2000 Series 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.
  • Page 14: Installing The Defibtech Data Card (Ddc Card) (Optional)

    WARNING 3.3 Installing The Defibtech Data Card (DDC Card) (Optional) The Defibtech Data Card (DDC card) is used to store event and audio information collected by the AED. All DDU- 2000 Series AEDs will operate without DDC cards and will still store critical event information internally. DDC cards may be reviewed with a separate Defibtech PC-based software package. (Refer to the “Defibview” section in Chapter 10 of this manual.)
  • Page 15: Installing And Removing The Battery Pack

    • 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 in Chapter 7 of this manual or call Defibtech for service. Active Status •...
  • Page 16: Completing The Installation

    The Active Status Indicator (ASI) should periodically flash with a green light. If it flashes with a red light or does not flash at all, the DDU-2000 Series AED needs servicing. (Refer to the “Checking The DDU-2000 Series AED Status” section in this chapter for more information.) Defibtech recommends storing your AED in an easily accessible location. DAC-E2510EN-BA...
  • Page 17: Using The Ddu-2000 Series In Aed Mode

    Using The DDU-2000 Series In AED Mode This chapter describes how to use the DDU-2000 Series in AED Mode. In AED Mode, the unit analyzes the patient’s rhythm and automatically charges if a shockable rhythm is detected. The DDU-2000 Series AED was designed for simple operation, allowing the operator to focus on the patient. There are two primary control buttons and a display screen.
  • Page 18 DDU-2400/2450 only) The user may then select AED Mode with video, AED Mode with ECG, or Manual Mode (available only for DDU-2400 with Manual Mode enabled) by pressing the corresponding softkey button. If no selection is made within 8 seconds, the AED will continue in the current mode.
  • Page 19: Preparation

    Text Prompts – The Text Prompt Area displays text prompts to guide the user during a rescue. Mode Select Softkey Icon (DDU-2400/2450 only) – When this icon is present on the screen (during a rescue), the user may press the corresponding softkey button to bring up the Mode of Operation selection screen.
  • Page 20 The Defibtech AED should be stored with the pads connector attached to the unit. However, if pads were damaged or not properly connected, you may need to substitute a new set of pads during an emergency.
  • Page 21 Applying The Defibrillation Pads To The Patient Apply pads correctly to patient. Follow AED voice and text prompts. Correct pad placement is essential for effective analysis of the patient’s cardiac rhythm and subsequent shock delivery (if required). Remove the pads from the pads package by tearing the package along the dotted line near the top of the package. Follow the directions and diagram showing proper defibrillation pad placement located on the defibrillation pads package and on the pads.
  • Page 22: Heart Rhythm Analysis

    Follow DDU-2000 Series AED Instructions At this point, the DDU-2000 Series AED will check to make sure that the pads are well connected to the patient and that an adequate ECG signal is being received. Do not touch the patient. Eliminate any patient movement, and cease CPR at this time.
  • Page 23: Post Use Procedures

    4.6 Post Use Procedures After the DDU-2000 Series AED has been used on a patient, the unit should be cleaned following procedures in the “Cleaning” section in Chapter 7 of this manual and prepared for the next use. The following steps should be performed: 1.
  • Page 24 Pad Connection/Pad Application Related Prompts (continued) Voice Text “Peel pads from blue liner” Peel Pads Purpose: This instructs the user to peel each pad from the blue liner before placing the pads on the patient. Peel the pads from the blue liner only when the pad is ready to be placed. Place the pads with the sticky side of the pad on the patient’s bare skin.
  • Page 25 Heart Rhythm Analysis Prompts Voice Text “Analyzing heart rhythm” Analyzing Rhythm “Analyzing” Analyzing Purpose: The DDU-2000 Series AED is actively analyzing the patient’s ECG signal. The AED will continue analyzing until it has determined whether a rhythm is shockable or non-shockable or if analyzing is interrupted for some reason. “Do not touch the patient”...
  • Page 26 Shock Related Prompts (continued) Voice Text “SHOCK button not pressed” Button Not Pressed Purpose: After shock is advised, the DDU-2000 Series AED will prompt user to press the flashing shock button. If after 30 seconds the shock button is not pressed, the DDU-2000 Series AED will give this prompt and immediately go to CPR mode.
  • Page 27: Operational Environment

    4.8 Operational Environment The Defibtech AED is designed to operate in a wide range of environmental conditions. To ensure the reliability and safety of the AED in a given environment, refer to the “Environmental” section in Chapter 11 of this manual for a detailed list of approved environmental conditions.
  • Page 28: Manual Mode (Ddu-2400 Only)

    M anual Mode (DDU-2400 only) The DDU-2400 AED provides a Manual Mode to override the AED features of the defibrillator. Manual Mode provides an ECG display of patient’s rhythm as well as operator-initiated charge, shock, and disarm functions. Manual Mode should only be used by qualified medical personnel trained in advanced life support skills and ECG recognition who want to deliver a shock independent of AED Mode.
  • Page 29: Selecting Energy

    5.3 Selecting Energy The user may select the desired energy level by pressing the softkey associated with the Energy Select Icon (upper button). The default energy when entering Manual Mode is always 150 J (adult pads) or 50 J (pediatric pads). Pressing the Energy Select Icon will cycle the energy through the following options: •...
  • Page 30: Ecg Monitor Mode (Ddu-2400/2450 Only)

    ECG Monitor Mode (DDU-2400/2450 only) At the discretion of emergency care personnel, the DDU-2400 and DDU-2450 AED can also be used with an optional ECG Monitoring Adapter (DAC-2020/2021) to provide a non-diagnostic ECG display of the patient’s heart rhythm for attended patient monitoring. The system is intended for use on a conscious or breathing patient, regardless of age.
  • Page 31: Monitoring The Patient

    6.3 Monitoring The Patient After the ECG monitoring electrodes are connected, the defibrillator displays a non-diagnostic ECG of the patient’s heart rhythm and heart rate in a Lead II configuration. While in ECG Monitor Mode, the defibrillator’s shock capability is disabled; however, the defibrillator continues to evaluate the patient’s ECG for a potentially shockable rhythm. Monitoring Plug In Rescue Pads ECG Monitor Mode Screen...
  • Page 32: Maintenance And Troubleshooting

    ASI should once again flash green. If it still does not flash green after inserting a new battery pack, the DDU-2000 Series AED is non-operational and may need servicing. Call Defibtech for service.
  • Page 33 The user should follow the text prompts to address the condition requiring attention. Card Application Softkey Icon: If an application is present on an inserted Defibtech Data Card (DDC card), a card icon will also appear next to the center softkey button.
  • Page 34 Replacing 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. The DDU-2000 Series AED defibrillation pads are supplied in a sealed pouch with the connector and part of the cable exposed.
  • Page 35 Each time the DDU-2000 Series AED is used, an event file is created on the DDC card (if installed). If the unit was used to treat a patient, the Defibtech Data Card (DDC card) in the unit should be removed and provided to the patient’s care provider.
  • Page 36: Self-Tests

    7.2 Self-Tests The DDU-2000 Series AED provides for both automatic and manually initiated self-tests. These self-tests test various components of the AED, including the system controls, battery pack condition, charge/discharge functions, and measurement and signal acquisition functions. Automatic Unit Self-Tests Every time the unit is turned on, power-on self-tests are performed to test the basic operation of the unit.
  • Page 37: Operator's Checklist

    The following checklist may be used as the basis for an Operator’s Checklist. The table should be copied and filled out as recommend by the schedule in the “Routine Unit Maintenance” section of this chapter. As each item is completed it should be checked off. Defibtech DDU-2000 Series Operator’s Checklist Defibtech AED Serial Number: DDU-2000 Series ___________________________________________________...
  • Page 38: Troubleshooting

    7.6 Troubleshooting The following table lists the symptoms, the possible causes, and the possible corrective actions for common problems. Refer to the other sections of the user manual for detailed explanations on how to implement the corrective actions. If the unit continues to be non-functional, refer the unit for servicing. (Refer to Chapter 14 of this manual for contact information.)
  • Page 39: Repair

    Pads not connected to unit “ Pads missing” prompt correctly and fully inserted into unit 7.7 Repair The DDU-2000 Series AED contains no user serviceable parts. If the unit needs servicing, call Defibtech. (Refer to Chapter 14 of this manual for contact information.) DAC-E2510EN-BA...
  • Page 40: Maintenance Mode

    Maintenance Mode 8.1 Overview Maintenance Mode for the Defibtech DDU-2000 Series AED 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. Maintenance Mode is navigated through a series of screens, menus, and menu options. In Maintenance Mode, the softkey buttons located directly to the right of the display screen are used to scroll through and select menu options.
  • Page 41: Entering Maintenance Mode

    8.3 Entering Maintenance Mode Before You Begin: Make certain the DDU-2000 Series AED is turned off and a battery pack is installed. STEP 1 – Press and release the CENTER softkey button. Result – The unit will turn on and display the AED Status AED status Screen for a short period of time.
  • Page 42: Aed Maintenance Screen

    The Upgrade AED menu selection is a method of performing a unit upgrade and will activate the system upgrade procedure from a Defibtech Data Card (DDC card) containing an upgrade application. Note: Upgrades can also be performed directly from the AED Status Screen if an upgrade card is present when the AED Status Screen mode is launched.
  • Page 43 Transfer Data To Card Transfer data to card will initiate a data transfer from the DDU-2000 Series AED to a Defibtech Data Card (DDC card) inserted in the device. Internal event data and device history is written to the DDC card.
  • Page 44: Aed Options Screen

     Run Application From Card Run application from card will initiate a card application on the Defibtech Data Card (DDC card). The most typical application is a software upgrade. Before you begin: Be sure the unit is in Maintenance Mode. Be sure a DDC Card, with a card application, is installed in the device.
  • Page 45 What it does: The unit will display the AED options menu screen. This screen will allow the user to modify the following user changeable parameters: • System time • System date • Volume level • Audio recording To exit: Using the TOP or BOTTOM softkey buttons, scroll to and highlight the selection. Go to main menu.
  • Page 46: Rescue Options Screen

    Audio Recording The Audio recording option allows the user to enable or disable recording of event audio data to a Defibtech Data Card (DDC card). Before you begin: Be sure the unit is in Maintenance Mode. To enter: Navigate to Audio recording: AED Main Menu Ú...
  • Page 47 This code is custom generated by Defibtech. If the code is not entered correctly the protocol will not be changed. Based on the protocol code entered, the currently selected protocol will be changed to that described by the special protocol code.
  • Page 48: Help Topics Screen

    Use the TOP and BOTTOM softkey buttons to select the desired mode. When the desired selection is chosen, press the CENTER softkey button to set the feature. The AED will now use that setting. Note: The factory default setting is set to “Enabled. ” This menu item is only available in the DDU-2400. Help Topics Screen The Help Topics option on the AED Main Menu provides a list of available help topics.
  • Page 49: Ddu-2000 Series Aed Accessories

    DDU-2000 Series AED Accessories This chapter describes the component parts and the accessories that can be used with the Defibtech DDU-2000 Series AED. For contact information on obtaining replacement component parts and accessories, refer to Chapter 14 in this manual.
  • Page 50: Usb Cable

    An optional USB cable may be used with the DDU-2000 Series AED for connecting the AED to a personal computer running Defibtech maintenance software. The AED has a mini-USB connector located on the right side of the unit behind the data card/USB port access door.
  • Page 51: Event Viewing

    Event Viewing This chapter includes information about Defibview, Defibtech Data Cards (DDC cards), and downloading internal data logs. 10.1 Defibview Defibview is a Windows-based software application that reads data stored on a DDC card or downloaded through the USB port and displays the data on a personal computer. Defibview serves the following primary functions: •...
  • Page 52: Technical Specifications

    Technical Specifications 11.1 Defibtech DDU-2000 Series AED General Category Specification 7 .3 x 9.5 x 2.3 inches Size 18.5 x 24 x 5.8 cm Weight Less than 3 lbs (1.4 kg) (with battery) Power Battery Pack (not rechargeable) Meets applicable requirements of •...
  • Page 53 • If defibrillation pads are removed from patient or unplugged from unit. • If operator presses the manual DISARM softkey or ON/OFF button pressed for Manual greater than 2 seconds Defibrillator – ECG Mode (DDU-2400 & DDU-2450 only) Category Specification ECG information is received from defibrillation pads in anterior-lateral or...
  • Page 54 Defibtech DDU-2000 Series AED (continued) Waveform Specifications In AED Mode, the DDU-2000 Series AED delivers a 150 J (Adult) 50 J (Pediatric) Biphasic Truncated Exponential waveform (AED Mode) to patients with impedances ranging from 25 to 180 ohms. In Manual Mode, the user can select the energy level.
  • Page 55 Defibtech DDU-2000 Series AED (continued) Energy – Manual Mode (DDP-2001 Adult and DDP-2003 Non-attenuating Pediatric Defibrillation Pads) (Nominal) Load Impedance (Ohms) Selected Energy 25 J 50 J 70 J 100 J 150 J 200 J DDP-2003 pediatric defibrillation pads Selected Energy range is limited from 25 to 100 J.
  • Page 56 Defibtech DDU-2000 Series AED (continued) Environmental Category Specification Temperature 0 – 50°C (32 – 122°F) Operating/ Humidity 5% – 95% (non-condensing) Maintenance Air Pressure 700 to 1060 hPa (21 to 31 inHg) Temperature 0 – 50°C (32 – 122°F) Standby/Storage/ Humidity 5% –...
  • Page 57 Specificity > 95% 1. From Defibtech ECG Rhythm Databases. 2. Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. American Heart Association (AHA) Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997;95:1677-1682.
  • Page 58: Battery Packs

    4 years* *Typical, new battery, at 25°C **typical, new battery depleted by 6 shocks, at 25°C 11.3 Self-Adhesive Defibrillation Pads Use only Defibtech defibrillation pads with your DDU-2000 Series AED. Defibtech self-adhesive defibrillation pads have the following characteristics: Model number DDP-2001 DDP-2002 and DDP-2003...
  • Page 59: Event Documentation

    11.7 Recycling Information At the end of useful life, recycle the defibrillator and its accessories. Recycling Assistance For recycling assistance contact your local Defibtech distributor. Recycle in accordance with local and national regulations. Preparation For Recycling Items should be clean and contaminant-free prior to being recycled.
  • Page 60: Electromagnetic Conformity

    DDU-2400/2450 AEDs are intended for use within the electromagnetic environment specified below. The customer or the user of the DDU-2400/2450 AED should assure that it is used within the stated environmental specifications. ELECTROMAGNETIC EMISSIONS...
  • Page 61 Electromagnetic Immunity (continued) IEC 60601 Compliance Electromagnetic environment – Immunity test test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the DDU-2000 Series, including cables, 10 V/m than necessary. The recommended 80 MHz to separation distance calculated Radiated RF...
  • Page 62 Regulatory Compliance Changes or modifications of this product, not expressly approved by Defibtech, may void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules and Industry Canada Radio Standard RSS-210. Operation is...
  • Page 63: Glossary Of Symbols

    13 Glossary Of Symbols Symbol Meaning High voltage present. SHOCK Button – Delivers defibrillation shock to the patient when the device is ready to shock. ON/OFF Button • Turns the device ON when it is OFF . • Turns the device OFF when it is ON. Caution, consult accompanying documents.
  • Page 64 Y Y Y Y Y Y Y Y Glossary Of Symbols (continued) Glossary Of Symbols (continued) Symbol Meaning Do not reuse. For USA users only. Catalogue number. Keep dry. Handle with care. Transportation and storage requirements. See environmental requirements. Authorized European Representative. Does not contain latex.
  • Page 65: Contacts

    14 Contacts Manufacturer Defibtech, L.L.C. 741 Boston Post Road Guilford, CT 06437 USA Y Y Y Y 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 manual is also suitable for:

Ddu-2000 seriesDdu-2500Ddu-2300Ddu-2000Ddu-2450

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