Related Manuals for Defibtech Lifeline DCF-100
Summary of Contents for Defibtech Lifeline DCF-100
- Page 1 Defibtech DDU-120 www.AmericanAED.com Fully Automatic External Defibrillator User Manual ELECTRONIC DISTRIBUTION AHA /ERC 2010 DAC-530E-EN-BH...
- Page 3 DAC-530E-EN-BH...
- 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-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 Preparation ......................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 8.2 Battery Packs ......................8.2.1 High-Capacity Lithium Battery Pack ............... 8.2.2 Standard Lithium Battery Pack ............... 8.3 Self-Adhesive Defibrillation/Monitoring Pads ............ 8.4 Defibtech Data Cards (DDCs) ................8.5 DefibView ....................... 9 Glossary of Symbols ...................57 10 Contacts ....................61 11 Warranty Information .................63...
- Page 8 viii DAC-530E-EN-BH...
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Page 9: Introduction To The Ddu-120 Series Aed
This User Manual provides information to guide trained operators in the use and maintenance of the Defibtech DDU-120 series Fully Automatic External Defibrillator (“AED”) and its accessories. This chapter includes an overview of the AED, a discussion of when it should and should not be used, and information on required operator training. -
Page 10: The Defibtech Ddu-120 Aed
The Defibtech AED is designed to deliver up to 150J of defibrillation energy through a patient impedance range of 25 – 180 ohms or 50J of defibrillation energy when using the child / infant pads. - Page 11 L. Patient pads. The defibrillation/monitoring pads that are placed on the patient. The pads may 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 DDU-120 AED.
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Page 12: Indications
In order to safely and effectively operate the DDU-120 AED, a person shall have met the following requirements: • Defibtech DDU-120 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
2 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
Do not attempt to recharge, short-circuit, puncture, or deform battery. Do not expose battery to temperatures above 50°C (122°F). Remove battery when depleted. WA RN I N G Recycle or dispose of lithium battery packs in accordance with with local, state, provincial, and/or national regulations. -
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 RN I N G defibrillation pads touching or gel surface exposed. -
Page 16: Pads
2.2.2 Pads Use only Defibtech disposable self-adhesive defibrillation/monitoring pads, battery packs, and other accessories supplied by Defibtech or its authorized distributors. Substitution of non-Defibtech approved accessories may cause WA RN I N G the device to perform improperly. Follow all defibrillation pad label instructions. Use defibrillation pads prior to ... -
Page 17: Shock Delivery
In patients with cardiac pacemakers, the DDU-120 AED may have reduced sensitivity and not detect all shockable rhythms. If you know the patient has an implanted pacemaker, do not place electrodes directly over an implanted device. WA RN I N G 2.2.4 Shock Delivery Do not allow defibrillation pads to touch each other, or to touch other ECG ... -
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-530E-EN-BH... -
Page 19: Setting Up The Ddu-120 Aed
3 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 battery pack is stored outside the unit for an extended period of time, removal of the 9V battery will extend the 9V battery’s life. Note that in an emergency situation, the battery pack may be used without a 9V battery. If needed, a non-lithium based 9V battery may also be used, but standby status indication life will be reduced. -
Page 22: Connecting The Pads
Within moments of insertion (if a non-discharged 9V ASI battery is installed) the DDU-120 will turn on and run a battery pack insertion self-test. The unit will automatically shut off after the test is run. Afterwards, the Active Status Indicator on the top corner of the DDU-120 AED will periodically flash (if a nondischarged 9V ASI battery was previously installed in the battery pack). -
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. Defibtech recommends storing your AED in an easily accessible location. DAC-530E-EN-BH... - Page 24 DAC-530E-EN-BH...
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Page 25: Using The Ddu-120 Aed
4 Using the DDU-120 AED This chapter describes how to use the DDU-120 AED. The DDU-120 AED was designed for simple operation, allowing the operator to focus on the patient. It has only one user control: the ON/OFF button. 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. -
Page 26: Checking Ddu-120 Aed Status
4.2 Checking DDU-120 AED Status Once a fully functional battery pack with a non-discharged 9V battery is installed in the DDU-120 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. -
Page 27: Preparation
This reduces the time needed to setup and start treatment in an emergency. The Defibtech AED should be stored with the pad connector plugged into the unit. However, if pads were damaged or not properly connected, you may need to substitute a new set of pads during an emergency. -
Page 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 the AED. -
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
not sticking due to excessive hair, shave or clip excessive chest hair. If the prompts continue, try replacing the pads with a new set. The “check pads” LED will flash red during this message. “Replace pads” – This indicates that the pads are not making proper contact with the patient and that the impedance is out of range for proper ECG analysis and shock delivery. -
Page 31: Delivering The Shock
Analysis related voice prompts: “Analyzing heart rhythm” – This indicates that the DDU-120 AED is actively analyzing the patient’s ECG signal. The AED will continue analyzing until it has determined whether a rhythm is shockable or non-shockable or analyzing is interrupted for some reason. The “analyzing” LED will flash green during this period. - Page 32 Shock related voice prompts: “Charging” – This indicates that the DDU-120 AED has determined that a shock is recommended and is charging the unit in anticipation of a defibrillation shock. Analysis will continue during this phase and the “analyzing” LED will continue to flash green. A tone will sound to indicate charging progress. 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.
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Page 33: No Shock Required
4.7 No Shock Required If the DDU-120 AED ECG analysis algorithm has determined that a shock is not required, 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 rhythm during this two minute CPR period. -
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 AED has delivered a shock, the unit will require a mandatory two-minute CPR period. -
Page 35: Post Use Procedures
• Check to make sure that the Active Status Indicator is flashing green. 4.10 Operational Environment The Defibtech AED is designed to operate in a wide range of environmental conditions. To ensure the reliability and safety of the AED in a given environment, refer to the “Environmental” section for a detailed list of approved environmental conditions. - Page 36 DAC-530E-EN-BH...
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Page 37: Maintaining And Troubleshooting The Ddu-120 Aed
5 Maintaining and Troubleshooting the DDU-120 AED This chapter describes the maintenance and troubleshooting procedures for the DDU-120 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. -
Page 38: Checking Active Status Indicator
5.2.1 Checking Active Status Indicator The Active Status Indicator (“ASI”) is located in the upper corner of the DDU-120 AED and indicates the operational readiness state of the unit. It will periodically flash green to indicate a fully functional condition. If it is flashing red or not flashing at all, the AED needs attention. Anytime the ASI is flashing red and a good 9V battery is installed, the unit will periodically emit a “beep”... -
Page 39: Checking The Condition Of The Unit And Accessories
5.2.4 Replacing Pads The Defibtech defibrillation/monitoring pads are intended for one time use only. The pads must be replaced after each use or if the package has been damaged. The DDU-120 AED defibrillation/monitoring pads are supplied in a sealed pouch with the connector and part of the cable exposed. -
Page 40: Checking Pad And Battery Pack Expiration Dates
First, check to ensure that the pad package has not expired. Pads past their expiration date should not be used and should be discarded. Next, check to ensure that the pads package has not been torn, opened or damaged. Dispose of the pads if the package is open or damaged. Inspect the pads cable and replace if any nicks, cuts, or broken cables are found. -
Page 41: Replacing The Lithium 9V Asi Battery
To remove the DDC card, press the DDC in all the way and then release. The DDC will be partially ejected and can be removed by pulling it the rest of the way out. To install a new DDC, insert the DDC, label side up, in the thin slot on the top of the opening for the battery pack. -
Page 42: Cleaning
5.4 Cleaning After each use, clean the DDU-120 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 DDU-120. •... -
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-120 Operator’s Checklist Defibtech DDU-120 Serial Number: ___________________________________________________... -
Page 44: 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 45 Symptom Possible Cause Corrective Action Unit will still operate to treat “Replace 9 volt battery” 9V battery low or missing patients, replace 9V battery as voice prompt soon as possible Make sure pads connector Connector not in properly is oriented correctly and fully inserted “Plug in pads connector”...
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Page 46: 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-BH... -
Page 47: Ddu-120 Aed Accessories
6 DDU-120 AED Accessories This chapter describes the components and accessories that can be used with the Defibtech DDU-120 AED. Information on obtaining replacement components and accessories is included in the “Contacts” section. 6.1 Defibrillation/Monitoring Pads The DDU-120 AED is used with Defibtech self-adhesive defibrillation/monitoring pads for adults or with attenuated pediatric pads for infants and children. -
Page 48: Battery Pack Active Status Indicator
The Active Status Indicator battery is a lithium 9 volt battery. 6.3 Data Cards The DDU-120 AED is designed to optionally use Defibtech Data Cards (“DDC”). The AED will operate with or without a DDC, but if a DDC is installed, additional event storage capacity is available. -
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: 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 51: Event Viewing
• Enables a patient’s primary care giver to review the emergency episode. • Allows Defibtech and regulatory personnel to reconstruct a cardiac episode for review of device performance. -
Page 52: Downloading The Internal Data Log
Downloading the Internal Data Log Regardless of whether a DDC is installed in the unit, select information is recorded internally within the DDU-120 AED. The information recorded is limited to: • The time the AED was turned on. • Other data such as event milestones (motion detection, shock advice, shock delivery information, etc). -
Page 53: 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. -
Page 54: Defibrillator
8.1.3 Defibrillator Category Specification Waveform Biphasic Truncated Exponential Adult: 150 Joules* Energy Infant / child: 50 Joules* Automatic by Patient Analysis System Charge control Typically < 6 seconds with a fresh DBP-2800 battery pack and < 9 seconds with a fresh DBP-1400 battery pack. Charge time from shock-advised Charge time may increase at the end of battery life and for temperatures below 10°C. -
Page 55: 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 DDU-120 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 56: 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 57: Patient Analysis System Performance
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 58: 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 59: 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-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... - Page 60 Immunity test IEC 60601 test Compliance level Electromagnetic environment - level guidance Voltage dips, short Not applicable Not applicable interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) 3 A/m 3 A/m Power frequency magnetic fields magnetic field should not be greater than levels IEC 61000-4-8...
- Page 61 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.
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Page 62: 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 63: Self-Adhesive Defibrillation/Monitoring Pads
Defibtech, L.L.C. for analysis. Refer to “Contacts” section for information on defect returns. 8.4 Defibtech Data Cards (DDCs) Use only Defibtech Data Cards in the DDU-120 AED. Defibtech Data Cards are available as follows: Standard DDCs: Model Number... -
Page 64: 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-530E-EN-BH... -
Page 65: Glossary Of Symbols
9 Glossary of Symbols Symbol Meaning High voltage present. Caution, consult accompanying documents. Shock Required Indicator – flashes 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. - Page 66 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 67 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 69: 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-530E-EN-BH... - Page 70 DAC-530E-EN-BH...
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Page 71: 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 72 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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