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

Fully automatic external defibrillator
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Defibtech DDU-120
Fully Automatic
External Defibrillator
User Manual
ELECTRONIC
DISTRIBUTION
AHA /ERC 2010
DAC-530E-EN-BD

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Summary of Contents for Defibtech DDU-120

  • Page 1 Defibtech DDU-120 Fully Automatic External Defibrillator User Manual ELECTRONIC DISTRIBUTION AHA /ERC 2010 DAC-530E-EN-BD...
  • Page 3 DAC-530E-EN-BD...
  • Page 4 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.

  • Page 5: Table Of Contents

    Contents 1 Introduction to the DDU-120 Series AED .............1 1.1 Overview ........................1.2 The Defibtech DDU-120 AED .................. 1.3 Indications ........................ 1.4 Contraindications ....................1.5 Operator Training Requirements ................2 Dangers, Warnings and Cautions ..............5 2.1 Shock, Fire Hazard, Explosion ................
  • Page 6 4.4.1 Call for Help ..................... 4.4.2 Preparing the Patient ..................4.4.3 Opening the Pad Package ................4.4.4 Connecting Defibrillation Pads to the DDU-120 AED ........4.4.5 Applying Pads to the Patient................4.4.6 Follow DDU-120 AED Prompts ............... 4.5 Heart Rhythm Analysis ..................
  • Page 7 7 Event Viewing .....................41 Defibtech Data Cards .................... Downloading the Internal Data Log ..............8 Technical Specifications ................43 8.1 Defibtech DDU-120 AED ..................8.1.1 General ......................8.1.2 Environmental....................8.1.3 Defibrillator ...................... 8.1.4 Waveform Specifications ................8.1.5 Patient Analysis System ..................
  • Page 8 viii DAC-530E-EN-BD...

  • Page 9: Introduction To The Ddu-120 Series Aed

    Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator. The DDU-120 AED has one push-button control and several LED indicators.

  • Page 10: The Defibtech Ddu-120 Aed

    C. “analyzing” LED (Light Emitting Diode). This green LED flashes when the DDU-120 AED is analyzing the patient’s ECG rhythm. D. “do not touch patient” LED. This red LED flashes when the DDU-120 AED detects motion or other interference that prevents analysis of the signal or when the user should not be touching or moving the patient.
  • Page 11 I. Battery pack opening. Insert the battery pack firmly into this opening until the latch clicks into place. J. Battery pack eject button. This button releases the battery pack from the DDU-120 AED. To remove the battery pack, push the button until the battery pack is partially ejected from the unit.

  • Page 12: Indications

    Indications The DDU-120 AED is indicated for use on victims of sudden cardiac arrest (“SCA”) when the patient is: • Unconscious and unresponsive. • Not breathing. For patients under 8 years old, use child/infant electrode pads. Do not delay therapy to determine exact age.

  • Page 13: Dangers, Warnings And Cautions

    This chapter includes a list of danger, warning, and caution messages that relate to the Defibtech DDU-120 AED and its accessories. Many of these messages are repeated elsewhere in this User Manual and on the DDU-120 AED or accessories. The entire list is presented here for convenience.

  • Page 14: Usage Environment

    The DDU-120 AED has not been evaluated or approved for use in hazardous  locations as defined in the National Electric Code standard. In compliance with IEC classification the DDU-120 AED is not to be used in the presence of DA N GE R flammable substance/air mixtures. Do not immerse any portion of this product in water or other fluids. Do not allow ...

  • Page 15: Maintenance

    Improper use can cause injury. Use the DDU-120 AED only as instructed in the  User Manual. The DDU-120 AED delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly. Do not discharge with WA R NI NG defibrillation pads touching or gel surface exposed.

  • Page 16: Pads

    Do not place adult defibrillation pads in the anterior-posterior (front-back)  position. A shock or no shock decision may be inappropriately advised. The DDU-120 AED requires that the adult defibrillation pads be placed in the anterior- WA RN I N G anterior (front-front) position.

  • Page 17: Shock Delivery

     Improper maintenance can cause the DDU-120 AED not to function. Maintain the DDU-120 AED only as described in this User Manual. The AED contains CAU T I O N no user serviceable parts – do not take the unit apart.
  • Page 18 DAC-530E-EN-BD...

  • Page 19: Setting Up The Ddu-120 Aed

    This chapter describes the steps required to make your Defibtech DDU-120 AED operational. The DDU-120 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 20: Installing The Data Card

    3.2 Installing the Data Card The Defibtech Data Card (“DDC”) is used to store event and audio information collected by the AED. All DDU-120 AEDs will operate without DDCs and will still store critical event information internally. Different DDC versions store different amounts of information. DDCs are available in versions that store and don’t store audio information.

  • Page 21: Installing And Removing The Battery Pack

    If the indicator does not flash, either the battery pack is defective or the 9V battery is discharged. Once the battery pack is installed into the unit, the DDU-120 AED’s Active Status Indicator should flash green every five seconds.

  • Page 22: Connecting The Pads

    Insert the connector end of the defibrillation pad cable into the pads connector port on the top-left corner of the DDU-120 AED as shown. Insert pads connector firmly until it is fully seated in the unit. The connected pad package can then be stored in the pad storage slot in the back of the DDU-120 AED.

  • Page 23: Performing Manually Initiated Self-Tests

    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 DDU-120 AED needs servicing – refer to the “Checking Active Status Indicator” section for more information.
  • Page 24 DAC-530E-EN-BD...

  • Page 25: Using The Ddu-120 Aed

    It also has four light emitting diode (LED) indicators. Concise and easily understandable voice messages and prompts guide the operator through the use of the unit. The following sections describe in detail how to use the DDU-120 AED. The basic steps for use are: • Turn the DDU-120 AED ON by pressing the ON/OFF button.

  • Page 26: Checking Ddu-120 Aed Status

    In this case, the 9V battery should be immediately replaced to restore active status indication. If only the 9V battery is depleted, the DDU-120 AED will still be fully functional when turned on and can be used in the on-state normally. • Off: Battery pack not installed, AED is defective, or the 9V battery is discharged.

  • Page 27: Preparation

    If any of these conditions is found, use a new set of pads. 4.4.4 Connecting Defibrillation Pads to the DDU-120 AED The DDU-120 AED is designed to be stored with the defibrillation pad connector attached to the unit, while the pads themselves remain sealed in their package.

  • Page 28: 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 DDU-120 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...

  • Page 29: Follow Ddu-120 Aed Prompts

    4.4.6 Follow DDU-120 AED Prompts At this point, the DDU-120 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 30: Heart Rhythm Analysis

    Motion/Interference related voice prompts: “Stop motion” – This indicates that the DDU-120 AED has detected motion in the patient. Stop all patient motion, including CPR, in response to this message. If the patient is being transported, stop the vehicle to stop the motion. The “do not touch patient” LED will flash red during this message.

  • Page 31: Delivering The Shock

    “Analyzing interrupted” – This indicates that the DDU-120 AED has determined that accurate ECG analysis is not possible and has ceased analyzing. The operator is prompted to resolve the problem – see “Follow DDU-120 AED Prompts” section. Once the problem is resolved, the unit will enter analysis mode again. The “analyzing” LED will not be illuminated during this message. “No shock advised” – This indicates that the DDU-120 AED has determined that a shock is not The unit will not charge. The user will be prompted to begin CPR, if needed, for a period required. of two minutes.

  • Page 32: No Shock Required

    “ Shock advised” – This indicates that the DDU-120 AED is about to deliver the shock. Stand clear of the patient. “ Three…two…one” – This indicates that the DDU-120 AED has fully charged, that the heart rhythm analysis algorithm still indicates a shock is recommended, and the unit is about to deliver a shock. The shock will automatically be delivered after the count reaches “One.

  • Page 33: Post-Shock Cpr

    “Stop now, ” “Do not touch the patient” – This indicates that the two-minute CPR period has ended and the user should stop CPR. The unit will enter Analyzing mode and the “analyzing” LED will flash. 4.8 Post-Shock CPR If the DDU-120 AED has delivered a shock, the unit will require a mandatory two-minute CPR period. No patient ECG rhythm monitoring will be done during this period. Once the two-minute period is complete, the AED will continue in Analyzing mode. Post-Shock CPR Voice Prompts: “It is safe to touch the patient”...

  • Page 34: Post Use Procedures

    flash. 4.9 Post Use Procedures After the DDU-120 AED has been used on a patient, the unit should be cleaned following procedures in the “Cleaning” section and prepared for the next use. The following steps should be performed: • Remove battery pack.

  • Page 35: Maintaining And Troubleshooting The Ddu-120 Aed

    five seconds. The unit will run a series of Self-Tests, report the results and will automatically shut down. If the DDU-120 AED is required for an emergency, push the ON/OFF button again to stop the Self-Tests and shut the unit off and then push the button to turn the unit on in the normal operating mode again.

  • Page 36: Routine Maintenance

    If the ASI is flashing red, turn the DDU-120 AED on. If the unit does not turn on or does not speak, the AED is non-operational and requires servicing. If the unit does turn on, the voice prompts will indicate the nature of the problem.

  • Page 37: Checking The Condition Of The Unit And Accessories

    The code number will indicate to the service personnel the type of problem that the unit is experiencing. “Service required” – This indicates that the DDU-120 AED has detected an internal error, is non- operational and needs servicing.

  • Page 38: Replacing Pads

    The DDU-120 AED defibrillation/monitoring pads are supplied in a sealed pouch with the connector and part of the cable exposed. The DDU-120 AED is designed to be stored with the electrode cable already installed. This allows the pads to be stored in a pre-connected state for rapid deployment during an emergency.

  • Page 39: Checking Pad And Battery Pack Expiration Dates

    In that case, remove the card, flip it over and try inserting it again. Note: A DDC is not required for the DDU-120 AED to operate. Even if a DDC card is not installed, basic essential information will still be recorded internally.

  • Page 40: Cleaning

    The following are important guidelines to be adhered to when cleaning the device: • The battery pack should be installed when cleaning the DDU-120. • Do not immerse the DDU-120 in fluids or allow fluids to enter the unit. Use a soft cloth to wipe the case clean.

  • Page 41: Operator's Checklist

    “Environmental” section. 5.6 Operator’s Checklist The following checklist may be used as the basis for an Operator’s Checklist. The table should be copied and illed out as recommend by the schedule in the “Routine Maintenance” section. As each item is completed it should be checked off. Defibtech DDU-120 Operator’s Checklist Defibtech DDU-120 Serial Number: ___________________________________________________ Defibtech DDU-120 Location: __________________________________________________________ Date: Check unit and accessories for damage, dirt and contamination.

  • Page 42: Troubleshooting

    5.7 Troubleshooting The following table lists the common causes for problems, the possible cause and the possible corrective actions. 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. Symptom Possible Cause Corrective Action Battery pack not inserted Insert battery pack Battery pack depleted or non-...
  • Page 43 Symptom Possible Cause Corrective Action Make sure pads connector Connector not in properly is oriented correctly and fully inserted “Plug in pads connector” voice prompt Pad connector broken Replace pads Unit’s connector broken Return unit for servicing Pads not connected to patient Place pads on patient Pads not making good connection to “Apply pads to patient’s bare Check pad connection to patient chest as shown”...

  • Page 44: Repair

    5.8 Repair The DDU-120 AED contains no user serviceable parts. If the unit need servicing, return to an authorized service center. Refer to “Contacts” section for contact information. DAC-530E-EN-BD...

  • Page 45: Ddu-120 Aed Accessories

    “leads-out” sealed package that allows the device to be stored with pads connected. When the DDU-120 AED is used, the operator needs only to remove the pad packaging, tear open the package and turn the device on to administer care.

  • Page 46: Battery Pack Active Status Indicator

    For example, the DDU-120 AED can record more than ten hours of ECG only or approximately one hour and forty minutes of audio and ECG data on a large DDC card.

  • Page 47: Recycling Information

    The DDC is inserted into a slot above the battery pack opening in the AED - refer to the “Installing the Data Card” section. A new and initialized DDC card should be used each time the AED is operated to maximize recording time. A new event ile is created on the DDC each time the AED is turned on and the following information is recorded (DDC cards may contain a maximum of 255 event files): •...

  • Page 48: Notice To European Union Customers

    6.4.4 Notice to European Union Customers The crossed-out wheeled bin symbol on this device indicates that this equipment has been put on the market after 13 August 2005, and is included in the scope of the directive 2002/96/ EEC on Waste Electrical and Electronic Equipment (WEEE) and of the national decree(s) which transpose provisions of such directive.

  • Page 49: Event Viewing

    For details about the features and use of the application, refer to the DefibView documentation. Defibtech Data Cards If a DDC is installed in the unit, every time the DDU-120 is turned on the following information is recorded on a new file on the card: • The time the AED was turned on.

  • Page 50: Downloading The Internal Data Log

    • Allow the unit to write the contents of the internal log to the DDC by waiting for the unit to turn off automatically. The DDU-120 will write the contents of the internal log onto the DDC. This information can then be reviewed using the DefibView software.

  • Page 51: Technical Specifications

    8 Technical Specifications 8.1 Defibtech 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 Equipment Classification Internally powered with defibrillator-proof BF-type patient applied parts. (per EN 60601-1) 8.1.2 Environmental...

  • Page 52: Defibrillator

    • If operator presses the OFF/DISARM button at any time Manual to disarm and turns off the device. 8.1.4 Waveform Specifications The DDU-120 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 below.

  • Page 53: Patient Analysis System

    If excessive artifacts inhibiting the DDU-120 AED Patient Analysis System from accurately determining the patient’s ECG rhythm are present in the ECG signal, the ECG signal processing system informs the user that interference and/or motion has been detected. The ECG signal processing stage also computes the ECG signal’s power spectrum.

  • Page 54: Shockable Rhythm Criteria

    8.1.5.1 Shockable Rhythm Criteria When placed on a patient meeting the indications for use criteria, the DDU-120 AED is designed to recommend a defibrillation shock when it detects proper pad impedance and one of the following: Peak-to-peak amplitude at least 200 µVolts.

  • Page 55: Patient Analysis System Performance

    Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997;95:1677-1682. Note: Additional information available upon request. 8.1.6 Clinical Summary The DDU-120 AED uses a Biphasic Truncated Exponential waveform with specifications that are substantially equivalent to the waveform specifications of the device used in the study cited below. The DDU-120 AED has not been the subject of a published clinical study.

  • Page 56: Methods

    8.1.6.2 Methods AEDs were prospectively randomized according to deibrillation 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 57: Guidance And Manufacturer's Declaration - Electromagnetic Emissions And Immunity

    8.1.7. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity Electromagnetic conformity Guidance and manufacturer’s declaration - The DDU-120 is intended for use in the electromagnetic environment specified below. The customer or the user of the DDU-120 should assure that it is used in such an environment. Electromagnetic emissions Emissions test Compliance Electromagnetic environment –...
  • Page 58 AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to ixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DDU-120 is used exceeds the applicable RF compliance level above, the DDU-120 should be observed to verify normal operation. If abnormal performance is observed additional measures may be necessary, such as reorienting or relocating the DDU-120.
  • Page 59 Separation Distances The DDU-120 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DDU-120 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DDU-120 as recommended below, according to the maximum output of the communications equipment. Recommended separation distances between portable and mobile RF communications equipment...

  • Page 60: Battery Packs

    8.2 Battery Packs 8.2.1 High-Capacity Lithium Battery Pack Category Specification DBP-2800 Model number Main battery type 15VDC, 2800 mAh, Lithium/Manganese Dioxide. Disposable, recyclable, non-rechargeable. Capacity A new battery typically will provide 300 shocks or 16 hours of operating time at 25°C. Charge time (fresh pack) Typically <...

  • Page 61: Self-Adhesive Defibrillation/Monitoring Pads

    Up to 1 hour and 40 minutes of Audio and ECG data Note: The DDU-120 will attempt to log at least an hour of ECG data if possible. In audio enabled DDCs, audio logging will be turned off if needed to preferentially record ECG information. If a partially filled DDC is used, it is possible that only ECG (i.e.

  • Page 62: Defibview

    8.5 DefibView DeibView is a PC based application program that allows review of ECG data and other patient and device performance parameters after an emergency event. DefibView runs on various Windows platforms including Windows 98, Windows 2000, and Windows XP . Minimum system requirements for adequate performance are as follows: • Pentium II Processor at 300 MHz. • 32 Mbyte System Memory. • 100 Mbyte free space on hard disk. Refer to the DeibView documentation for a complete description of the application. DefibView is available for download at the Defibtech website at www.defibtech.com. DAC-530E-EN-BD...

  • Page 63: Glossary Of Symbols

    9 Glossary of Symbols Symbol Meaning  High voltage present.  Refer to operating instructions (User Manual). Shock Required Indicator – lashes to indicate that a shock is about to be delivered. auto ON/OFF/DISARM Button – - Turns the device ON when it is OFF . - Turns the device OFF when it is ON. - DISARMS the device when it is charged and then turns the device OFF .  Caution, consult accompanying documents (User Manual). Do not expose to high heat or open flame.
  • Page 64 Temperature limitation. Use by (yyyy-mm). Defibrillation protected - Type BF connection. Date of manufacture. Do not re-use. ! USA For USA users only. Catalogue number. Manufacturer and date of manufacture. Y Y Y Y Serial number. DAC-530E-EN-BD...

  • Page 65: Contacts

    10 Contacts Defibtech, L.L.C. 741 Boston Post Road Guilford, CT 06437 USA Tel.: (866) 333-4241 (Toll-free within North America) (203) 453-4507 Fax : (203) 453-6657 Emails: sales@defibtech.com (Sales) reporting@deibtech.com (Medical Device Reporting) service@deibtech.com (Service and Repair) European Authorized Representative: Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel.: +31 70 345 8570 Fax:...
  • Page 66 DAC-530E-EN-BD...

  • Page 67: Warranty Information

    CAUSE, BUSINESS INTERRUPTION OF ANY NATURE, LOSS specified maintenance is not performed; the defibrillator is used with one, or more, unauthorized accessories; the OF PROFITS OR PERSONAL INJURY, EVEN IF DEFIBTECH, associated accessories are used with an unauthorized LLC HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES, HOWEVER OCCASIONED, WHETHER BY defibrillator;...
  • Page 68 Patents pending. This product and its accessories are manufactured and sold under one or more of the following United States patents: D514,951; 6,955,864; D499,183. This product and its accessories are manufactured and sold under license to at least one or more of the following United States patents: 5,591,213; 5,593,427; 5,601,612;...

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