Defibtech DDU-120 Fully Automatic External Defibrillator User Manual AHA /ERC 2010 ELECTRONIC DISTRIBUTION DAC-530E-EN-BH
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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.
Contents 1 Introduction to the DDU-120 Series AED......................................................1 1.1 1.2 1.3 1.4 1.5 Overview................................................................................................................... 1 The Defibtech DDU-120 AED................................................................................... 2 Indications................................................................................................................. 4 Contraindications.....
4.4 Preparation.............................................................................................................. 19 4.4.1 Call for Help...................................................................................................... 19 4.4.2 Preparing the Patient........................................................................................ 19 4.4.3 Opening the Pad Package................................................................................ 19 4.4.
Event Viewing..............................................................................................43 7.1 7.2 Defibtech Data Cards............................................................................................. 43 Downloading the Internal Data Log...................................................................... 44 8 Technical Specifications..............................................................................45 8.1 Defibtech DDU-120 AED..................................
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1 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. 1.
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. Energy delivered does not change significantly with patient impedance, although the duration of the generated waveform will vary.
H. Battery pack. The battery pack provides a replaceable main power source for the DDU-120 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-120 AED. To remove the battery pack, push the button until the battery pack is partially ejected from the unit. K. Active Status Indicator (ASI).
1.3 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. The DDU-120 AED must be used by or on the order of a physician. 1.4 Contraindications The DDU-120 AED should not be used if the patient shows any of the following signs: • Conscious and/or responsive. • Breathing.
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. DANGER: Immediate hazards that will result in serious personal injury or death. WARNING: Conditions, hazards, or unsafe practices that may result in serious personal injury or death.
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. Recycle or dispose of lithium battery packs in accordance with with local, state, provincial, and/or national regulations. To avoid fire and explosion hazard, do not burn or incinerate the battery. WARNING CAUTION 2.1.3 Usage Environment Possible fire or explosion. Do not use in the presence of flammable gases or anesthetics.
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 defibrillation pads touching or gel surface exposed. Disconnect all non-defibrillator proof equipment from the patient before defibrillation to prevent electrical shock hazard and potential damage to that equipment.
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 the device to perform improperly. Follow all defibrillation pad label instructions. Use defibrillation pads prior to their expiration date. Do not re-use defibrillation pads.
WARNING 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. 2.2.4 Shock Delivery Do not allow defibrillation pads to touch each other, or to touch other ECG electrodes, lead wires, dressings, transdermal patches, etc.
2.3 General CAUTION 10 DAC-530E-EN-BH Federal law (USA) restricts this device to sale by or on the order of a physician.
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. 3.1 Overview The following components and accessories are included with your DDU-120 AED. Replacement and other accessories are detailed in the “DDU-120 AED Accessories” section.
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. Refer to the DDC technical specification for exact storage capabilities.
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. Once the fresh 9V battery is installed, the battery pack status LED should periodically flash green to indicate a ready state.
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).
3.6 Performing Manually Initiated Self-Tests Upon initial setup, perform a manual Self-Test as described below: Note that a manual Self-Test consumes approximately one shock’s worth of energy, and will therefore reduce the usable capacity of the battery. To perform a manual Self-Test, begin with the unit powered off. Press and hold the ON/OFF button until the unit announces that it is performing a Self-Test – this should take approximately 5 seconds.
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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. The following sections describe in detail how to use the DDU-120 AED. The basic steps for use are: • • • • • 4.
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. Anytime the ASI blinks red and a good 9V battery is installed, the unit will also “beep” periodically to call attention to itself.
4.4 Preparation 4.4.1 Call for Help As soon as the AED is turned on the unit will prompt the user to “call for help”. This indicates that the first step in a rescue should always be to contact professional emergency services. If another person is available, the user should direct that person to call for help and then continue the rescue without delay. 4.4.2 Preparing the Patient Prepare the patient by removing any clothing from the patient’s chest.
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. When the pad pack is fully inserted, press the pad cable into the groove in the back of the unit to hold it in place and tuck any excess cable behind the pad package. 4.4.
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. If there is a problem with the pad connection, connector connection, patient motion or other interference, the AED will guide the operator with audible and visual prompts.
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. If another set of pads is available, replace the pads, otherwise check that the pads are properly placed and fully adhering to the patient.
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. “Do not touch the patient” – This indicates that the DDU-120 AED is trying to analyze the patient’s heart rhythm and that the operator should not touch the patient.
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.
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. During this two-minute period, the AED will not advise the user to “stop motion” even if motion is present. During the two-minute period, the AED will announce time remaining in 15-second intervals.
“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.
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. Remove DDC if installed. Replace with a new DDC. Reinsert battery pack. Check that the Battery Pack Insertion Self-Test passes. Connect a new pad package (check to make sure the package is not expired).
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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. The DDU-120 AED contains no user serviceable parts except for the ASI 9V battery. 5.
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” to call attention to itself.
5.2.2 Checking the Condition of the Unit and Accessories Inspect the unit for cracks or other signs of damage on the case, as well as dirt or contamination, especially in the areas around the connector socket and battery pack opening. If any cracks or other signs of damage are observed, remove the unit from service and contact an autorized service center. If any dirt or contamination is observed, refer to the “Cleaning” section for guidance on cleaning your unit. 5.2.
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. Insert the connector end of the defibrillation pad cable into the pads connector port on the corner of the DDU-120 AED as shown.
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. The card should click into place and be flush with the surface of the slot. If the card does not push in all the way, it may have been inserted upside down. In that case, remove the card, flip it over and try inserting it again.
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. • Do not immerse the DDU-120 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.
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.
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 9V battery low or missing Unit will still operate to treat patients, replace 9V battery as soon as possible Connector not in properly Make sure pads connector is oriented correctly and fully inserted 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 patient Check pad connection to patient Pads or pad cable damaged Replace pads Dry
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.
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.
The main battery is based on a lithium battery technology and provides the AED with a long shelf and standby life. Battery pack status indication is provided by a blinking green status LED. Status indicator power is supplied by a user replaceable 9V lithium battery. 6.2.1 Battery Pack Active Status Indicator The battery pack’s Active Status Indicator (“ASI”) is located on the label face of the battery pack and is used to indicate battery pack status.
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 file 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): • The time the AED was turned on. • Other data such as: ECG data, time data, audio data (audio enabled card only).
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.
7 Event Viewing DefibView is a Windows based software application that reads data stored on a DDC and displays it on a personal computer. DefibView serves four primary functions: • Enables emergency care personnel to reconstruct a cardiac episode from the time the AED was turned on and connected to the patient until the unit is turned off. • Enables a patient’s primary care giver to review the emergency episode.
7.2 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).
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) Weight Approximately 4.2 lbs (1.9 kg) with DBP-1400 Battery pack Approximately 4.4 lbs (2 kg) with DBP-2800 Battery pack Equipment Classification (per EN 60601-1) Internally powered with defibrillator-proof BF-type patient applied parts. 8.1.
8.1.3 Defibrillator Category Specification Waveform Biphasic Truncated Exponential Energy Adult: 150 Joules* Infant / child: 50 Joules* Charge control Automatic by Patient Analysis System Charge time from shock-advised Typically < 6 seconds with a fresh DBP-2800 battery pack and < 9 seconds with a fresh DBP-1400 battery pack. Charge time may increase at the end of battery life and for temperatures below 10°C.
Adult Patient Impedance (Ohms) Phase A, Duration (msec) Phase B, Duration (msec) Energy Delivered (Joules) 25 2.8 2.8 153 50 4.1 4.1 151 75 7.2 4.8 152 100 9.0 6.0 151 125 12.0 8.0 153 150 12.0 8.0 146 175 12.0 8.0 142 Patient Impedance (Ohms) Phase A, Duration (msec) Phase B, Duration (msec) Energy Delivered (Joules) 25 4.1 4.1 35 50 5.8 3.8 47 75 5.8 3.8 51 100 7.2 4.8 53 125 7.2 4.8 52 150 9.0 6.0 53 175 9.0 6.0 51 Pediatric 8.1.
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. Ventricular Fibrillation Warning: Some very low amplitude or low frequency VF rhythms may not be interpreted as shockable. Ventricular Tachycardia Cardiac rhythm rate of at least 180 bpm and peak-to-peak amplitude at least 200 µVolts.
8.1.5.
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.
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 RF emissions CISPR 11 Compliance Group 1 Class B Electromagnetic environment – guidance The DDU-120 uses RF energy only for its internal function.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Not applicable Not applicable Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should not be greater than levels characteristic of a typical location in a commercial or hospital environment. Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.
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.
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. Disposable, recyclable, non-rechargeable.
8.3 Self-Adhesive Defibrillation/Monitoring Pads Use only Defibtech Pads with your DDU-120 AED.
8.5 DefibView DefibView 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.
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. - DISARMS the device when it is charged and then turns the device OFF. Do not expose to high heat or open flame. Do not incinerate. Recyclable. Consult operating instructions.
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. YYYY YYYY Date of manufacture. YYYY YYYY YYYY YYYY Manufacturer and date of manufacture. YYYY YYYY Do not reuse. For USA users only. Federal Law (USA) restricts this device to sale by or on the order of a physician. Catalogue number. Keep dry. Handle with care.
Symbol Meaning LATEX Does not contain 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. 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.
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10 Contacts Defibtech, L.L.C. 741 Boston Post Road Guilford, CT 06437 USA YYYY Tel.: Fax : 1-(866) 333-4241 (Toll-free within North America) 1-(203) 453-4507 1-(203) 453-6657 Email: sales@defibtech.com (Sales) reporting@defibtech.com (Medical Device Reporting) service@defibtech.
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11 Warranty Information ORIGINAL END USER’S LIMITED WARRANTY* COVERAGE Defibtech, LLC provides a limited warranty that the defibrillator and its associated accessories (e.g., batteries and pads), whether purchased concurrently with the defibrillator as part of a configuration or separately, shall be substantially free from defects in material and workmanship.
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.
