Defibtech DDU-100 User Manual
Semi-automatic external defibrillator
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Summary of Contents for Defibtech DDU-100
- Page 1 Defibtech DDU-100 www.AmericanAED.com Semi-Automatic External Defibrillator User Manual ELECTRONIC DISTRIBUTION AHA /ERC 2010 DAC-510E-EN-BG...
- Page 3 DAC-510E-EN-BG...
- 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.
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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 ..............
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Page 9: Introduction To The Ddu-100 Series Aed
(impedance varies with the electrical resistance of the patient’s body). Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator. The DDU-100 AED has two push-button controls and several LED indicators. -
Page 10: The Defibtech Ddu-100 Aed
E. “check pads” LED. This red LED flashes when the DDU-100 AED detects that the pad connection to the patient is poor or pads are not applied. F. ON/OFF button. Push button to turn the DDU-100 AED on. Push again to disarm and turn the AED off. - Page 11 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. J. Battery pack eject button. This button releases the battery pack from the DDU-100 AED. To remove the battery pack, push the button until the battery pack is partially ejected from the unit.
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Page 12: Indications
• 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. -
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
The DDU-100 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-100 AED is not to be used in the presence of DA N G E R flammable substance/air mixtures. -
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 WA RN I N G with 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 WA RN I N G anterior-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-BG... -
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-BG...
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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
4.3 Turning on the DDU-100 AED Press the ON/OFF button to turn the DDU-100 AED on. The unit will emit a “beep” and all the LEDs will light up temporarily. The ON/OFF button will illuminate green anytime the AED is on. -
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. -
Page 31: Delivering The Shock
The “analyzing” LED will flash green during this period. “Do not touch the patient” – This indicates that the DDU-100 AED is trying to analyze the patient’s heart rhythm and that the operator should not touch the patient. This message will be spoken at the beginning of the analysis period and also if motion or interference has been detected. - Page 32 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.
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Page 33: No Shock Required
At the end of the two-minute period, the unit will enter normal Analyzing mode. No Shock Required Voice Prompts: “It is safe to touch the patient” – This indicates that the DDU-100 AED analysis algorithm has determined that no shock is required. The unit will not charge and the SHOCK button will not be enabled. -
Page 34: Post-Shock Cpr
If the AED has delivered a shock, the unit will require a mandatory two-minute CPR period. DDU-100 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. -
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. - Page 36 DAC-510E-EN-BG...
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Page 37: Maintaining And Troubleshooting The Ddu-100 Aed
9V battery is present to check the integrity of the unit’s hardware and software. Manually initiated Self-Tests may be run to test the DDU-100’s systems, including the charging and shocking functions (the shock is internally dissipated and no voltage will be present at the pads) at any time. -
Page 38: Routine Maintenance
If it does not, the battery pack may be defective. In that event, the battery pack should be replaced. If it still does not flash after inserting a new battery pack, the DDU-100 AED is non- operational and needs servicing. -
Page 39: Checking The Condition Of The Unit And Accessories
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 40: Running A Manually Initiated Self-Test
5.2.3 Running a Manually Initiated Self-Test The DDU-100 AED runs a Power-On Self-Test every time the unit is powered up to test the basic operation of the unit. The unit also runs daily, weekly and monthly automatic Self-Tests when a non-depleted 9V battery is present. -
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. -
Page 44: 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: ___________________________________________________... -
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. - 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...
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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-BG... - Page 48 DAC-510E-EN-BG...
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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
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: •... -
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... -
Page 56: Defibrillator
* nominal (±15%) delivered into a 50 ohm load. 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. -
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. -
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. -
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 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 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.
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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
• 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-BG... -
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. Internally powered with defibrillator-proof BF-type patient applied parts (per EN 60601-1). Manufacturer. Y Y Y Y Y Y Y Y Y Y Y Y Date of manufacture.
- Page 69 Symbol Meaning 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.
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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) DAC-510E-EN-BG... - Page 72 DAC-510E-EN-BG...
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Page 73: 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 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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