Defibtech DDU-120 User Manual
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Defibtech DDU-120 User Manual

Lifeline aed ddu-100 series automated external defibrillator
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  • Page 1 Defibtech Lifeline AED Manual Get an original copy of the Defibtech Lifeline AED Operators Guide for manufacturer information about service, available accessories and how to use and maintain your device.

  • Page 2: User Manual

    Defibtech DDU-100 Series Automated External Defibrillator • DDU-100 • DDU-120 User Manual For comprehensive training on set-up, use and maintenance; source for complete technical specifications ELECTRONIC DISTRIBUTION DAC-A580-EN-DF...
  • Page 3 DAC-A580-EN-DF...

  • Page 4: Limited Warranty

    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 any examples are fictitious unless otherwise noted.

  • Page 5: Table Of Contents

    2.3 Cautions ........................3 Setting Up the DDU-100 Series AED ............11 3.1 Overview ....................... 3.2 Installing the Defibtech Data Card (“DDC”) ............3.3 Installing the Active Status Indicator 9V Battery ..........3.4 Installing and Removing the Battery Pack ............3.5 Connecting the Pads ....................
  • Page 6 5.2.5 Checking Pad and Battery Pack Expiration Dates ........5.2.6 Checking the Defibtech Data Card ..............5.2.7 Checking the AED Software Version Number ..........5.2.8 Running an Application from a Defibtech Data Card ........5.3 Replacing the Active Status Indicator 9V Battery ........... 5.4 Cleaning .........................
  • Page 7 7 Event Viewing ................... 43 DefibView ......................7.2 Defibtech Data Cards (DDC Cards) ..............7.3 Downloading the Internal Data Log..............7.3.1 Downloading the Internal Data Log Using a DDC Card ......8 Technical Specifications ................45 8.1 Defibtech DDU-100 & DDU-120 AED..............

  • Page 8: Introduction To The Ddu-100 Series Aed

    The operator must press the SHOCK button to initiate defibrillation. • DDU-120 — The DDU-120 is a fully automatic external defibrillator. It has only one user control: the ON/OFF button. It WILL shock a patient automatically without additional interaction by the operator if a shock is advised.

  • Page 9: The Defibtech Ddu-100 Series Aed

    (audio enabled cards only) if sufficient space is available on the card. Audio recording is available only for units with installed audio-enabled Defibtech Data Cards. Event documentation stored internally can be downloaded onto a DDC for review.
  • Page 10 L. Patient pads. The defibrillation pads that are placed on the patient. The pads should be stored in the pad storage area on the back of the unit. M. Defibtech Data Card (DDC). This optional plug-in card provides enhanced storage capabilities to the AED.

  • Page 11: Indications

    In order to safely and effectively operate the DDU-100 Series AED, a person shall have met the following requirements: • Defibtech DDU-100 Series AED and/or defibrillation training as required by local, state, provincial, or national regulations. • Any additional training as required by the authorizing physician.

  • Page 12: 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-100 Series AED and its accessories. Many of these messages are repeated elsewhere in this User Manual and on the DDU-100 Series AED or accessories. The entire list is presented here for convenience.
  • Page 13 WA R N I N G 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 WA R N I N G perform improperly.
  • Page 14 Warnings (continued)  Do not open sealed pads package until pads are to be used. WA R N I N G  Do not touch the patient during defibrillation. Defibrillation current can cause operator or bystander injury. WA R N I N G ...
  • Page 15 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 WA R N I N G damaged during use. Possible Radio Frequency (RF) interference from RF devices such as cellular ...

  • Page 16: Cautions

    Do not re-use defibrillation pads. Discard defibrillation pads after use (in the event of suspected pad malfunction, return pads to C AU T I O N Defibtech for testing).  The defibrillation pads should not be in continuous contact with the patient’s skin for more than 24 hours.
  • Page 17 If possible, disconnect the DDU-100 Series AED from the patient prior to use of other defibrillators. C AU T I O N  Using non-Defibtech Data Cards (DDC cards) may damage the unit and will void the warranty. C AU T I O N ...

  • Page 18: Setting Up The Ddu-100 Series Aed

    3 Setting Up the DDU-100 Series AED This chapter describes the steps required to make your Defibtech DDU-100 Series AED operational. The DDU-100 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 19: Installing The Defibtech Data Card ("Ddc")

    3.2 Installing the Defibtech Data Card (“DDC”) The Defibtech Data Card (“DDC”) is used to store event and audio information collected by the AED. All DDU-100 Series AEDs will operate without DDCs and will still store select event information internally.

  • Page 20: Installing And Removing The Battery Pack

    3.4 Installing and Removing the Battery Pack NOTE: DDU-100 series AEDs will continue to perform standby and ASI functions without the 9V ASI battery installed, but battery pack standby life will be reduced. The lithium battery pack provides power to the DDU-100 Series AED. Before inserting the battery pack into the AED, the 9V lithium battery should be installed in the battery pack itself as described in the previous section.

  • Page 21: Performing Manually-Initiated Self-Tests

    First, check to ensure that the pad package has not expired. Pads past their expiration date should not be used and should be discarded. Insert the connector end of the defibrillation pad cable into the pads connector port on the top-left corner of the AED as shown at left. Insert the pads connector firmly until it is fully seated in the unit.

  • Page 22: Storing The Aed

    The Active Status Indicator should periodically blink with a green light. If it blinks with a red light or does not blink at all, the AED needs servicing (refer to Section 4.2 for more information). Defibtech recommends storing your AED in an easily-accessible location where the unit can be seen and heard. DAC-A580-EN-DF...

  • Page 23: Using The Ddu-100 Series Aed

    Indicator do not touch patient shock when the button LEDs analyzing is flashing. DDU-120: SHOCK Required auto Indicator Flashes when a shock is Speaker advised and the unit has charged and is about to deliver a shock.

  • Page 24: Checking The Aed Status

    4.2 Checking the AED Status Once a fully-functional battery pack is installed in the AED, an LED indicator located in the corner of the unit actively indicates unit status. If the unit is fully operational, the Active Status Indicator (“ASI”) will blink green and if the unit needs attention, the ASI will blink red. When the ASI blinks red, the unit will also “beep”...

  • Page 25: Preparation

    4.4 Preparation 4.4.1 Call for Help As soon as the AED is turned on the unit will prompt the user to “Call for Help” . This indicates that the first step in a rescue should always be to contact professional emergency services. If another person is available, the user should direct that person to call for help and then continue the rescue without delay.

  • Page 26: Applying Pads To The Patient

    If not needed for immediate use, the pad package can then be stored in the pad storage slot in the back of the AED. After connecting the pads connector to the unit, push the pad package, with the pictures on the package facing up and out, rounded end first, into the pad holder compartment on the back of the AED.

  • Page 27: Follow Aed Prompts

    4.4.6 Follow AED Prompts At this point, the 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. If there is a problem with the pad connection, connector connection, patient motion or other inter- ference, the AED will guide the operator with audible and visual prompts.

  • Page 28: No Shock Required

    4.7 No Shock Required If the AED’s ECG analysis algorithm has determined that a shock is not advised, it will not charge the unit, and the DDU-100 AED’s SHOCK button will not be enabled. If needed, the operator will be prompted to begin CPR.

  • Page 29: Aed Voice Prompts

    4.10 AED Voice Prompts 4.10.1 General Prompts “Call for help” Purpose: As soon as the AED is turned on, the user will be prompted to call for help. This indicates that the first step in a rescue should always be to contact professional emergency services.
  • Page 30 Pad Connection/Pad Application Related Prompts (continued) “Apply pads to patient’s bare chest as shown” Purpose: The AED has determined that the pads are not placed on the patient or not properly applied. Place pads on the patient following instructions on the pads package. If the prompts continue, try replacing the pads with a new set.

  • Page 31: Motion/Interference Prompts

    4.10.3 Motion/Interference Prompts “Stop motion” Purpose: The AED has detected possible motion in the patient. Stop all patient motion, including CPR, in response to this prompt. “Stop interference” Purpose: The AED has detected interference on the ECG signal. Eliminate any radio or electrical sources of interference.

  • Page 32: Shock-Related Prompts

    Purpose: The AED has aborted the shock. If the unit detects a rhythm change to a non- shockable rhythm, the unit will cancel the shock. Also, on the DDU-120 AED, if the SHOCK button is not pressed within 30 seconds of the initial “Press flashing SHOCK button” prompt, the unit will automatically cancel the shock.

  • Page 33: No Shock Required Prompts

    Purpose: The AED has determined that a shock is not required. The unit will not charge and the unit will not enable the SHOCK button (DDU-100) or automatically deliver the shock (DDU-120). If the AED is charged, the shock will be canceled. The user will be prompted to begin CPR.

  • Page 34: Led Indicators

    Flashes when DDU-100 AED is fully charged and ready to (DDU-100 ONLY) deliver a shock (user must press button to deliver a shock). Flashes when DDU-120 AED is about to automatically “SHOCK Required” (auto) deliver a shock. Do not touch the patient while this LED (DDU-120 ONLY) indicator is flashing.

  • Page 35: Maintaining And Troubleshooting The Ddu-100 Series Aed

    5 Maintaining and Troubleshooting the DDU-100 Series AED This chapter describes the maintenance and troubleshooting procedures for the DDU-100 Series AED. The Self-Tests that are automatically performed by the device are described along with recommended routine maintenance. A troubleshooting guide is provided to help diagnose user serviceable problems.

  • Page 36: Routine Maintenance

    5.2 Routine Maintenance The DDU-100 Series 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 environment where the AED is deployed, and ultimately the maintenance program is at the discretion of the emergency response program’s medical director.

  • Page 37: Maintenance-Related Prompts

    5.2.2 Maintenance-Related Prompts “Power-on test failed” “Service code ‘xxxx’ ” Purpose: This indicates that the AED has failed the power-on self-test and may be non- operational and may require servicing. The code number will indicate to service personnel the type of problem the unit is experiencing. “Battery test failed”...

  • Page 38: Checking The Condition Of The Aed And Accessories

    5.2.3 Checking the Condition of the AED and Accessories Inspect the unit for cracks or other signs of damage on the case, as well as dirt or contamination, especially in the areas around the connector socket and battery pack opening. If any cracks or other signs of damage are observed, remove the unit from service and contact an authorized service center.

  • Page 39: Checking Pad And Battery Pack Expiration Dates

    5.2.6 Checking the Defibtech Data Card Each time the AED is used, an event file is created on the Defibtech Data Card (if installed). If the unit was used to treat a patient, the DDC in the unit should be removed and provided to the patient’s care provider.

  • Page 40: Checking The Aed Software Version Number

    5.2.8 Running an Application from a Defibtech Data Card To run an application from a Defibtech Data Card (DDC), perform the following procedure: 1. Press the orange battery pack eject button to eject the battery pack from the AED.

  • Page 41: Replacing The Active Status Indicator 9V Battery

    complete, the AED will announce “AED Upgrade Complete, Version X point X” where “X point X” is the software version number (i.e. “Version 3 point 2”). The unit should then be powered off by pressing the green ON/OFF button (NOTE: If the AED does not power off when the ON/OFF button is pressed, the upgrade is still in progress).

  • Page 42: Cleaning

    5.4 Cleaning Periodically clean the AED of any dirt or contaminants on the case and connector socket. The following are important guidelines to be adhered to when cleaning the device: • The battery pack should be installed when cleaning the AED. •...

  • Page 43: 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 Maintenance” section. As each item is completed, it should be checked off. Defibtech DDU-100 Series Operator’s Checklist AED Serial Number: ___________________________________________________...

  • Page 44: Troubleshooting

    Use the chart below to determine the appropriate corrective action based upon what prompt was spoken by the unit. If the unit continues to be non-functional, contact Defibtech (see Chapter 10 for information). Symptom...
  • Page 45 Troubleshooting (continued) Symptom Possible Cause Corrective Action Replace battery pack as soon as “Battery low” prompt Battery pack capacity is getting low possible “Unknown battery type” Battery pack not recommended for Replace installed battery pack prompt use with unit (see Section 8.2) with recommended battery pack Make sure pads connector “Pads missing”...

  • Page 46: Repair

    5.8 Repair The DDU-100 Series AED contains no user serviceable parts except for the ASI 9V battery. If the unit needs servicing, contact Defibtech (see Chapter 10 for contact information). DAC-A580-EN-DF...

  • Page 47: Ddu-100 Series Aed Accessories

    6 DDU-100 Series AED Accessories This chapter describes the components and accessories that can be used with the Defibtech DDU-100 Series AED. For contact information on obtaining replacement component parts and accessories, refer to Chapter 10 of this manual. For more information about accessories, please visit www.defibtech.com or contact Defibtech or your distributor.

  • Page 48: Active Status Indicator 9V Lithium Battery

    DDC card into the unit. The DDC slot is located just inside the battery pack opening. For instructions on how to install and remove a DDC card, refer to Section 3.2 (“Installing the Defibtech Data Card”) of this manual. To download data from the card, refer to Section 7 .2 (“Downloading the Internal Data Log”).

  • Page 49: Recycling Information

    6.4 Recycling Information At the end of its useful life, recycle the defibrillator and its accessories. 6.4.1 Recycling Assistance For recycling assistance contact your local Defibtech distributor. Recycle in accordance with local and national regulations. 6.4.2 Preparation Items should be clean and contaminant-free prior to being recycled. When recycling used disposable electrodes, follow local clinical procedures.

  • Page 50: Event Viewing

    • Other data such as: ECG data, time data, audio data (audio-enabled cards only), event milestones such as: motion detection, shock advice, shock delivery information.. This information can be reviewed using the DefibView application. Caution: Using non-Defibtech Data Cards (DDC cards) may damage the unit and will void the warranty. DAC-A580-EN-DF...

  • Page 51: Downloading The Internal Data Log

    Downloading the Internal Data Log Regardless of whether a DDC card is installed in the unit, select information is recorded internally within the DDU-100 Series AED. The information recorded is limited to: • The time the AED was turned on. •...

  • Page 52: Technical Specifications

    8 Technical Specifications 8.1 Defibtech DDU-100 & DDU-120 AED 8.1.1 General Category Specification Size 8.5 x 11.8 x 2.7 inches (22 x 30 x 7 cm) Approximately 4.2 lbs (1.9 kg) with DBP-1400 battery pack Weight Approximately 4.4 lbs (2 kg) with DBP-2800 battery pack...

  • Page 53: Defibrillator

    (“Shocking in 3, 2, 1... ” ) DDU-100: Shock is delivered by a single SHOCK button Shock delivery DDU-120: Fully automatic • If Patient Analysis System decides rhythm is no longer shockable • Within 30 seconds after Charge complete, if operator has not pressed...

  • Page 54: Waveform Specifications

    8.1.4 Waveform Specifications The DDU-100 Series AED delivers a 150J Biphasic Truncated Exponential waveform to patients with impedances ranging from 25 to 180 ohms. V max V min The waveform is adjusted to compensate for measured patient impedance. Nominal phase times and energy delivered are shown in the tables that follow.

  • Page 55: Patient Analysis System

    8.1.5 Patient Analysis System The Patient Analysis System ensures that the pad/patient impedance is within the proper range and analyzes the patient’s ECG rhythm to determine whether a shock is required. On detection of a non-shockable rhythm, the user is prompted to perform CPR. For shockable rhythms, the AED automatically charges in preparation for shock delivery.

  • Page 56: Patient Analysis System Performance

    AHA recommendation rhythms of 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.

  • Page 57: Methods

    8.1.6.2 Methods AEDs were prospectively randomized according to defibrillation waveform on a daily basis in four emergency medical services systems. First responders used either the 150-J biphasic AEDs or 200- to 360-J monophasic waveform AEDs on victims where defibrillation was indicated. A sequence of up to three defibrillation shocks was delivered: 150J-150J-150J for the biphasic units and 200J-200J-360J for the monophasic units.

  • Page 58: Electromagnetic Conformity

    8.1.7 Electromagnetic Conformity Guidance And Manufacturer’s Declaration The essential performance of the DDU-100 Series AED is successful delivery of defibrillation therapy and accurate differentiation between shockable and nonshockable rhythms. DDU-100 Series AEDs are intended for use within the electromagnetic environment specified below.
  • Page 59 Electromagnetic Immunity (continued) Electromagnetic environment Immunity test IEC 60601 test level Compliance level – guidance Portable and mobile RF communications equipment should be used no closer to any part of the DDU-100 Series AED, including cables, than necessary. The recommended separation 20 V/m distance calculated from the 80 MHz to 2.5 GHz...
  • Page 60 Separation Distances DDU-100 Series AEDs are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of a DDU-100 Series AED can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DDU-100 Series AED as recommended below, according to the maximum output of the communications equipment.
  • Page 61 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 subject to the following two conditions:...

  • Page 62: Battery Packs

    8.2 Battery Packs IMPORTANT NOTE: DDU-100 Series AEDs that carry the marking shown at left on the pad holder label on the unit’s rear panel (see Section 5.2.7 for diagram) should use DBP-1400 and DBP-2800 battery packs that also include this marking. Earlier model battery packs without this marking will function during a rescue, but should not be used for standby.

  • Page 63: Defibrillation Pads

    2.5 years from date of manufacture Note: In the event of a suspected pad defect, the pads should be clearly marked “Not for Use” and returned to Defibtech for analysis. (Refer to the “Contacts” section of this manual for contact information regarding returns.) 8.4 Defibtech Data Cards (DDCs)

  • Page 64: Defibview

    DefibView is a PC-based application program that runs on Windows platforms. It allows review of ECG data and other patient and device performance parameters after an emergency event. To download DefibView software and see system requirements specifications, go to www.defibtech.com/support and click on “Software Utilities.” DAC-A580-EN-DF...

  • Page 65: Glossary Of Symbols

    SHOCK Button – Delivers defibrillation shock to the patient when the device is ready to shock. (DDU-100 ONLY) SHOCK Required Indicator – Flashes to indicate that a shock is about to be delivered. (DDU-120 ONLY) auto ON/OFF/DISARM Button – - Turns the device ON when it is OFF .
  • Page 66 Glossary of Symbols (continued) Symbol Meaning Meets the requirements of the European Medical Device Directive. Meets the requirements of the Radio Equipment and Telecommunications Directive, 1999/5/EC. Operational temperature limitation. Use by yyyy-mm-dd. Defibrillation proof - Can withstand the effects of an externally applied defibrillation shock. Internally powered with defibrillator-proof BF-type patient applied parts (per EN 60601-1).
  • Page 67 Glossary of Symbols (continued) Symbol Meaning Handle with care. Transportation and storage requirements. See environmental requirements on packaging. Authorized European Representative: Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Does not contain latex. LATEX Lot number. IP54 Dust protected; Protected against water jets. Classified by TUV Rheinland of NA with respect to electric shock, fire, and mechanical hazard only in accordance with UL 60601-1, CAN/CSA C22.2 No.601.1-M90, IEC 60601-1, and IEC 60601-2-4.

  • Page 68: Contacts

    YY Y Y- MM - D D Y Y Y Y- M M - D D 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) DAC-A580-EN-DF...

  • Page 69: Warranty Information

    CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE. The limited warranty is immediately voided if: the defibrillator DEFIBTECH, LLC SHALL IN NO EVENT BE LIABLE FOR ANY or its associated accessories are serviced or repaired by any CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, entity, including persons, not authorized by Defibtech, LLC;...
  • Page 70 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. For additional patent information, please see: www.defibtech.com/support/patents DAC-A580-EN-DF...

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