Defibtech DDU-100 User Manual
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Defibtech DDU-100 User Manual

Semi-automatic external defibrillator
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Defibtech DDU-100
Semi-Automatic
External Defibrillator

User Manual

ELECTRONIC
DISTRIBUTION
AHA /ERC 2010
DAC-510E-EN-BF

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Summary of Contents for Defibtech DDU-100

  • Page 1: User Manual

    Defibtech DDU-100 Semi-Automatic External Defibrillator User Manual ELECTRONIC DISTRIBUTION AHA /ERC 2010 DAC-510E-EN-BF...
  • Page 3 DAC-510E-EN-BF...

  • 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 the examples are fictitious unless otherwise noted.

  • Page 5: Table Of Contents

    Contents 1 Introduction to the DDU-100 Series AED .............1 1.1 Overview ........................1.2 The Defibtech DDU-100 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-100 AED ........4.4.5 Applying Pads to the Patient................4.4.6 Follow DDU-100 AED Prompts ............... 4.5 Heart Rhythm Analysis ..................
  • Page 7 7 Event Viewing .....................45 Defibtech Data Cards .................... Downloading the Internal Data Log ..............8 Technical Specifications ................47 8.1 Defibtech DDU-100 AED ..................8.1.1 Physical......................8.1.2 Environmental....................8.1.3 Defibrillator ...................... 8.1.4 Waveform Specifications ................8.1.5 Patient Analysis System .................. 8.1.5.1 Shockable Rhythm Criteria ..............
  • Page 8 viii DAC-510E-EN-BF...

  • Page 9: Introduction To The Ddu-100 Series Aed

    Overview The DDU-100 AED is a Semi-Automatic External Defibrillator (“AED”) that is designed to be easy to use, portable and battery powered. It has only two user controls: the ON/OFF and SHOCK buttons. Voice prompts and visual indicators provide a simple interface for the operator. The DDU-100 AED is capable of recording event information including ECG, audio data (optional), and SHOCK/NO-SHOCK recommendations.

  • Page 10: The Defibtech Ddu-100 Aed

    AED and of the patient to the operator. The DDU-100 AED has two push-button controls and several LED indicators. Defibrillation energy is delivered as an impedance compensated biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load when using adult pads or when using attenuated child / infant pads, 50J of defibrillation energy into a 50-ohm load.
  • Page 11 G. Pads connector port. Insert Patient Pads Connector (item O) into this port to connect pads to DDU-100 AED. H. Battery pack. The battery pack provides a replaceable main power source for the DDU-100 AED. I. Battery pack opening. Insert the battery pack firmly into this opening until the latch clicks into place.

  • Page 12: Indications

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

  • Page 13: Dangers, Warnings And Cautions

    This chapter includes a list of danger, warning, and caution messages that relate to the Defibtech DDU-100 AED and its accessories. Many of these messages are repeated elsewhere in this User Manual and on the DDU-100 AED or accessories. The entire list is presented here for convenience.

  • Page 14: Usage Environment

    National Electric Code standard. In compliance DA N G E R with IEC classification the DDU-100 AED is not to be used in the presence of 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-100 AED only as instructed in the User Manual. The DDU-100 AED delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly. Do not discharge with WA RN I N G 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-100 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-100 AED not to function. Maintain the DDU-100 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: General

    2.3 General  Federal law (USA) restricts this device to sale by or on the order of a physician. CAU T I O N DAC-510E-EN-BF...

  • Page 19: Setting Up The Ddu-100 Aed

    This chapter describes the steps required to make your Defibtech DDU-100 AED operational. The DDU-100 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-100 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-100 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-100 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-100 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-100 AED needs servicing – refer to the “Checking Active Status Indicator” section for more information.
  • Page 24 DAC-510E-EN-BF...

  • Page 25: Using The Ddu-100 Aed

    (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-100 AED. The basic steps for use are: • Turn the DDU-100 AED ON by pressing the ON/OFF button.

  • Page 26: Checking Ddu-100 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-100 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-100 AED The DDU-100 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-100 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 29: Follow Ddu-100 Aed Prompts

    4.4.6 Follow DDU-100 AED Prompts At this point, the DDU-100 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-100 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-100 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-100 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-100 AED has determined that a shock is not required. The unit will not charge and the SHOCK button will not be enabled. The user will be prompted to begin CPR, if needed, for a period of two minutes.
  • Page 32 If the unit detects a rhythm change to a non-shockable one, charging will abort and the user will be prompted to begin CPR, if needed, for a period of two minutes. “Stand clear” – This indicates that the DDU-100 AED is charging and that the operator and others should stand clear of the patient. Analysis will continue during this phase and the “analyzing” LED will continue to flash green. A tone will sound to indicate charging progress.

  • Page 33: No Shock Required

    4.7 No Shock Required If the DDU-100 AED ECG analysis algorithm has determined that a shock is not required, it will not charge the unit and the SHOCK button will not be enabled. The operator will be prompted to begin CPR, if needed, for a period of two minutes. The unit will not be monitoring the patient’s ECG...

  • Page 34: 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-100 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” – This indicates that it is safe for the user to touch the patient.

  • Page 35: Post Use Procedures

    4.9 Post Use Procedures After the DDU-100 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. • Remove DDC if installed. Replace with a new DDC.
  • Page 36 DAC-510E-EN-BF...

  • Page 37: Maintaining And Troubleshooting The Ddu-100 Aed

    The Self-Tests that are performed by the device are described along with the frequency and nature of periodic maintenance for which the owner/operator is responsible. A troubleshooting guide is provided to help diagnose user serviceable problems. The DDU-100 AED contains no user serviceable parts except for the ASI 9V battery. 5.1 Self-Tests Power-On Self-Tests are performed every time the unit is turned on to test the basic operation of the unit.

  • Page 38: Routine Maintenance

    If the ASI is flashing red, turn the DDU-100 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 39: Checking The Condition Of The Unit And Accessories

    Maintenance Related Voice Prompts: “Power-on self-test failed, service code ‘xxx’ ” – This indicates that the DDU-100 AED has failed the power-on self-test and is non-operational and needs servicing. The code number will indicate to the service personnel the type of problem that the unit is experiencing.

  • Page 40: Running A Manually Initiated Self-Test

    The pads must be replaced after each use or if the package has been damaged. The DDU-100 AED defibrillation/monitoring pads are supplied in a sealed pouch with the connector and part of the cable exposed. The DDU-100 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 41: Checking Pad And Battery Pack Expiration Dates

    5.2.6 Checking the DDC If One Was Installed Each time the DDU-100 AED is used, an event file is created on the DDC (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...

  • Page 42: Replacing The Lithium 9V Asi Battery

    Note: A DDC is not required for the DDU-100 AED to operate. Even if a DDC card is not installed, basic essential information will still be recorded internally. The AED will still operate properly even after a “replace memory card” message.

  • Page 43: Cleaning

    The following are important guidelines to be adhered to when cleaning the device: • The battery pack should be installed when cleaning the DDU-100. • Do not immerse the DDU-100 in fluids or allow fluids to enter the unit. Use a soft cloth to wipe the case clean. • Do not use abrasive materials or strong solvents such as acetone or acetone based cleaning agents.

  • Page 44: Operator's Checklist

    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 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 Operator’s Checklist Defibtech DDU-100 Serial Number: ___________________________________________________ Defibtech DDU-100 Location: __________________________________________________________ Date: Check unit and accessories for damage, dirt and contamination. Clean or replace as necessary.

  • Page 45: 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 46 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 47: Repair

    5.8 Repair The DDU-100 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-510E-EN-BF...
  • Page 48 DAC-510E-EN-BF...

  • Page 49: Ddu-100 Aed Accessories

    6 DDU-100 AED Accessories This chapter describes the components and accessories that can be used with the Defibtech DDU-100 AED. Information on obtaining replacement components and accessories is included in the “Contacts” section. 6.1 Defibrillation/Monitoring Pads The DDU-100 AED is used with Defibtech self-adhesive defibrillation/monitoring pads for adults or with attenuated pediatric pads for infants and children.

  • Page 50: Battery Pack Active Status Indicator

    For example, the DDU-100 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 51: Recycling Information

    Data Log”). 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 52: 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 53: 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-100 is turned on the following information is recorded on a new file on the card: • The time the AED was turned on.

  • Page 54: 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-100 will write the contents of the internal log onto the DDC. This information can then be reviewed using the DefibView software.

  • Page 55: Technical Specifications

    8 Technical Specifications 8.1 Defibtech DDU-100 AED 8.1.1 Physical 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 8.1.2 Environmental Category Specification Temperature 0 – 50°C (32 – 122°F) Operating / Maintenance Humidity 5% –...

  • Page 56: 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-100 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 57: Patient Analysis System

    Adult Patient Impedance Phase A, Duration Phase B, Duration Energy Delivered (Ohms) (msec) (msec) (Joules) 7 .2 12.0 12.0 12.0 Pediatric Patient Impedance Phase A, Duration Phase B, Duration Energy Delivered (Ohms) (msec) (msec) (Joules) 7 .2 7 .2 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...

  • Page 58: Shockable Rhythm Criteria

    8.1.5.1 Shockable Rhythm Criteria When placed on a patient meeting the indications for use criteria, the DDU-100 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.  Ventricular Fibrillation...

  • Page 59: Patient Analysis System Performance

    The DDU-100 AED has not been the subject of a published clinical study. 8.1.6.1 Background The objective of this study was to compare AEDs that delivered 150-J biphasic shocks with AEDs that delivered high-energy (200- to 360-J) monophasic shocks.

  • Page 60: 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 61: 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-100 is intended for use in the electromagnetic environment specified below. The customer or the user of the DDU-100 should assure that it is used in such an environment. Electromagnetic emissions Emissions test Compliance Electromagnetic environment –...
  • Page 62 AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DDU-100 is used exceeds the applicable RF compliance level above, the DDU-100 should be observed to verify normal operation. If abnormal performance is observed additional measures may be necessary, such as reorienting or relocating the DDU-100.
  • Page 63 Separation Distances The DDU-100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DDU-100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DDU-100 as recommended below, according to the maximum output of the communications equipment. Recommended separation distances between portable and mobile RF communications equipment...

  • Page 64: Battery Packs

    8.2 Battery Packs 8.2.1 High-Capacity Lithium Battery Pack Category Specification Model number DBP-2800 Main battery type 15VDC, 2800 mAh, Lithium/Manganese Dioxide. Disposable, recyclable, non-rechargeable. Capacity 300 shocks or 16 hours of continuous operation.* Charge time < 6 seconds* Standby-life (installed in unit) 7 years* Active Status Indicator (ASI) battery 9VDC, 1200 mAh, Lithium/Manganese Dioxide.

  • Page 65: Self-Adhesive Defibrillation/Monitoring Pads

    Up to 1 hour and 40 minutes of Audio and ECG data Note: The DDU-100 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 66: Defibview

    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 DefibView documentation for a complete description of the application. DefibView is available for download at the Defibtech website at www.defibtech.com. DAC-510E-EN-BF...

  • Page 67: Glossary Of Symbols

    9 Glossary of Symbols Symbol Meaning  High voltage present. Caution, consult accompanying documents. SHOCK Button – Delivers defibrillation shock to the patient when the device is ready to shock. ON/OFF/DISARM Button – - Turns the device ON when it is OFF . - Turns the device OFF when it is ON.
  • Page 68 Symbol Meaning Use by (yyyy-mm). Defibrillation proof - Can withstand the effects of an externally applied defibrillation shock. Y Y Y Y Internally powered with defibrillator-proof BF-type patient applied parts (per EN 60601-1). Y Y Y Y Manufacturer. Y Y Y Y Y Y Y Y Date of manufacture.
  • Page 69 Symbol Meaning 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. Conforms to UL Standard UL 60601-1. Certified to CAN/CSA Standard C22.2 No. 601.1-M90. Serial number. Lithium Manganese Dioxide Battery. Product is not sterile. DAC-510E-EN-BF...
  • Page 70 DAC-510E-EN-BF...

  • Page 71: Contacts

    10 Contacts Defibtech, L.L.C. 741 Boston Post Road Guilford, CT 06437 USA Y Y Y Y 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) European Authorized Representative: Emergo Europe Molenstraat 15...
  • Page 72 DAC-510E-EN-BF...

  • Page 73: Warranty Information

    At Defibtech, LLC’s sole discretion, Defibtech shall have the option to repair, replace, or provide a credit. In the event of replacement, Defibtech shall have the right at its sole *Applicable to defibrillators and associated accessories discretion to replace the item with a new, or refurbished, same having a date of manufacture on or after January 1, 2013.
  • Page 74 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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