Defibtech DDU-2000 Series Automated External Defibrillator • • DDU-2300 DDU-2450 User Manual For comprehensive training on set-up, use and maintenance; source for complete technical specifications ELECTRONIC DISTRIBUTION DAC-A2510EN-BG
PRESS “ON” BUTTON 1 APPLY PADS 2 FOLLOW AED INSTRUCTIONS 3 2 DAC-A2510EN-BG
Notices Defibtech, L.L.C. 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 any examples are fictitious unless otherwise noted. Limited Warranty The “Limited Warranty” shipped with Defibtech AED products serves as the sole and exclusive warranty provided by Defibtech, L.L.C.
Contents 1 2 Introduction To The DDU-2000 Series AED.......................................................6 1.1 Overview............................................................................................................................ 6 1.2 The Defibtech DDU-2000 Series AED................................................................................ 8 1.3 Usage...............................................................................................................................
7 8 Maintenance Mode...........................................................................................38 7.1 Overview.......................................................................................................................... 38 7.2 Navigation (in Maintenance Mode)................................................................................... 38 7.3 Entering Maintenance Mode............................................................................................ 39 7.
Introduction To The DDU-2000 Series AED 1. Introduction 1 This User Manual provides information to guide trained operators in the use and maintenance of the Defibtech DDU-2000 Series Automated External Defibrillator (AED) and its accessories. It includes comprehensive training on set-up, use, and maintenance and is the source for complete technical specifications.
1. Introduction Defibrillation and AED operating power is supplied with a replaceable (non-rechargeable) battery pack that provides for long standby life and low maintenance operation. Each battery pack is marked with an expiration date. The DDU-2000 Series AED records event documentation internally and, optionally, on a Defibtech Data Card (DDC). The optional DDC card inserts into a slot in the AED and enables the AED to record event documentation and, optionally, audio data onto the card.
1.2 The Defibtech DDU-2000 Series AED B. S HOCK Button. This button will flash when a shock is recommended. Pressing this button will deliver a shock when the button is flashing. This button is disabled at all other times. C. D isplay Screen. Color display panel used to display text and video prompts, messages, indicators for rescue, unit status, and maintenance operations. The display screen provides visual prompts, including CPR coaching. DDU-2450 models can also show an ECG trace. D. ON/OFF Button.
E. Pads Connector Socket C. Display Screen G. S oftkey Buttons (Top, Center, Bottom) B. SHOCK Button H. USB Port A. Speaker I. D efibtech Data Card (DDC Card) (optional) FRONT OF AED J. U SB and Defibtech Data Card (DDC Card) Access Door R. E CG Monitoring Adapter (optional; DDU-2450 only) K. Battery Pack Opening L. B attery Pack Eject Release Latch M. Pad Storage Area N. Pads Connector BACK OF AED O. Defibrillation Pads P. D efibrillation Pads Expiration Date Q.
1.3 Usage 1. Introduction Indications The DDU-2000 Series Automated External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are: • Unconscious and unresponsive • Not breathing or not breathing normally For patients under 8 years old, or weighing less than 55 lbs (25 kg), use child/infant defibrillation pads, if available. Do not delay therapy to determine exact age or weight. Apply the pads as shown for a child/infant and use the AED.
2 Dangers, Warnings, And Cautions This chapter includes a list of danger, warning, and caution messages that relate to the Defibtech DDU-2000 Series AED and its accessories. Many of these messages are repeated elsewhere in this User Manual and on the DDU-2000 Series AED or accessories. The entire list is presented here for convenience. 2.1 ! ! DANGERS: ! Immediate hazards DANGER that will result in serious personal injury or death. CAUTION WARNING • Hazardous electrical output.
WARNINGS (continued) • Avoid contact between parts of the patient’s body and conductive fluids such as water, gel, blood or saline, and metal objects, which may provide unwanted pathways for defibrillating current. • Disconnect all non-defibrillator proof equipment from the patient before defibrillation to prevent electrical shock hazard and potential damage to that equipment. • Aggressive or prolonged CPR to a patient with defibrillation pads attached can cause damage to the pads.
3 Setting Up The DDU-2000 Series AED This chapter describes the steps required to make your Defibtech DDU-2000 Series AED operational. The DDU-2000 Series 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-2000 Series AED.
3.2 Connecting The Defibrillation Pads The DDU-2000 Series AED defibrillation pads are supplied sealed in a package with the connector and part of the cable exposed. WARNING DO NOT open the sealed pads package until the pads are to be used. The packaging should be opened only immediately prior to use, otherwise the pads may dry out and become non-functional. Note: The DDU-2000 Series AED is designed to be stored with the pads connector already installed.
3.4 Checking The DDU-2000 Series AED Status Active Status Indicator (ASI) Once a fully functional battery pack is installed in the DDU-2000 Series AED, an LED indicator located to the right of the ON/OFF button actively indicates unit status. If the unit is ready for use, the Active Status Indicator (ASI) will flash green. Ready for use means that the DDU-2000 Series has passed the most recent self-test (scheduled or user initiated). If the unit needs service, the ASI will flash red.
3.5 Installing The Defibtech Data Card (DDC Card) (optional) The Defibtech Data Card (DDC card) is used to store event and audio information collected by the AED. All DDU-2000 Series AEDs will operate without DDC cards and will still store select event information internally. Information stored on the DDC card is retrievable with a separate Defibtech PC-based software package. (Refer to the “DefibView” section in Chapter 9 of this manual.) Before installing the DDC card, ensure the AED is turned OFF.
4. Using The DDU-2000 Series in AED Mode 4 Using The DDU-2000 Series In AED Mode This chapter describes how to use the DDU-2000 Series in AED Mode. In AED Mode, the unit analyzes the patient’s rhythm and automatically charges if a shockable rhythm is detected. Push-button controls include an ON/OFF button, three softkey buttons, and a SHOCK button. All units inlcude a display screen.
4. Using The DDU-2000 Series in AED Mode Overview (continued) Unit Video Display Screen (During AED Mode) Battery Indicator Rescue Breathing Options Softkey Icon Information Softkey Icon Main Screen Text Prompts Give 30 Compressions Mode Select Softkey Icon (DDU-2450 only) (sample display screen) Battery Indicator – The Battery Indicator indicates the approximate remaining battery capacity. Main Screen – The Main Screen displays video instructions to guide the user during a rescue.
4. Using The DDU-2000 Series in AED Mode Unit ECG Display Screen (During AED Mode, DDU-2450 only) Battery Indicator Main Screen Text Prompts Analyzing Mode Select Softkey Icon (sample display screen) Battery Indicator – The Battery Indicator indicates the approximate remaining battery capacity. Heart Rate Indicator – The Heart Rate Indicator displays the patient’s heart rate. Elapsed Time – The Elapsed Time displays the time since the start of the event in hr:min:sec.
4. Using The DDU-2000 Series in AED Mode Selecting an Alternate Spoken Language Follow Instructions Some AED models are factory configured to support an alternate spoken language. If the AED supports an alternate language, a Language Softkey Icon (represented in the form of a flag) will be displayed. When the Language Softkey Icon is present, the user may press the corresponding softkey to switch the spoken voice prompts to the alternate language. (Note: Text prompts continue in the primary language.
4. Using The DDU-2000 Series in AED Mode Applying The Defibrillation Pads To The Patient Follow this procedure to apply the defibrillation pads to the patient: 1. Tear the defibrillation pads package along the dotted line near the top of the package. 2. Remove the pads from the package and follow the directions and diagram showing proper pad placement located on the pads package. 3. Peel off the protective backing from one of the pads before placing it as shown on the diagram on the pad.
4. Using The DDU-2000 Series in AED Mode Follow DDU-2000 Series AED Instructions At this point, the DDU-2000 Series 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.
4. Using The DDU-2000 Series in AED Mode 4.6 Post-Use Procedures After the DDU-2000 Series AED has been used on a patient, the unit should be cleaned following procedures in the “Cleaning” section in Chapter 6 of this manual and prepared for the next use. The following steps should be performed: 1. Connect a new pads package (check to make sure the package is not expired and package is not damaged). 2. Perform a self-test manually. Unit will report status at the end of the self-test.
4. Using The DDU-2000 Series in AED Mode Pad Connection/Pad Application-Related Prompts (continued) Voice Text “Peel adhesive pads from blue liner” Peel Pads Purpose: This instructs the user to peel each pad from the blue liner before placing the pads on the patient. Peel the pads from the blue liner only when the pad is ready to be placed. Place the pads with the sticky side of the pad on the patient’s bare skin.
4. Using The DDU-2000 Series in AED Mode Heart Rhythm Analysis Prompts Voice Text “Analyzing heart rhythm” “Analyzing” Analyzing Rhythm Analyzing Purpose: The DDU-2000 Series 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 if analyzing is interrupted for some reason.
4. Using The DDU-2000 Series in AED Mode Shock-Related Prompts (continued) Voice Text “SHOCK button not pressed” Button Not Pressed Purpose: After shock is advised, the DDU-2000 Series AED will prompt user to press the flashing shock button. If after 30 seconds the shock button is not pressed, the AED will give this prompt and immediately go to CPR mode. Note: The DDU-2000 Series AED will not automatically deliver a shock – the user must press the SHOCK button.
4. Using The DDU-2000 Series in AED Mode CPR Coaching Help Prompts Voice Text “Place hands” Place Hands Purpose: This reminds the user of the correct placement of hands for CPR. “Press” “Compress Chest” Press Compress Chest Purpose: This reminds the user to perform CPR compressions. “Tilt head back” “Pinch nose” “Give rescue breaths” Tilt Head Back Pinch Nose Give “x” Breaths Purpose: This guides the user to prepare the patient for rescue breaths and to give breaths.
5 ECG Monitor Mode (DDU-2450 only) At the discretion of emergency care personnel, the DDU-2450 AED can also be used with an optional ECG Monitoring Adapter (DAC-2020/2021) to provide a non-diagnostic ECG display of the patient’s heart rhythm for attended patient monitoring. The system is intended for use on a conscious or breathing patient, regardless of age. While connected to the ECG Monitoring Adapter, the DDU-2450 AED’s shock capability is disabled, but it continues to evaluate the patient’s ECG.
5.3 Monitoring The Patient After the ECG monitoring electrodes are connected, the defibrillator displays a non-diagnostic ECG of the patient’s heart rhythm and heart rate in a Lead II configuration. While in ECG Monitor Mode, the defibrillator’s shock capability is disabled; however, the defibrillator continues to evaluate the patient’s ECG for a potentially shockable rhythm.
6. Maintenance and Troubleshooting 6 Maintenance and Troubleshooting This chapter describes the maintenance and troubleshooting procedures for the DDU-2000 Series AED. The selftests that are automatically performed by the device are described along with recommended routine maintenance. A troubleshooting guide is provided to help diagnose user serviceable problems. The DDU-2000 Series AED contains no user serviceable parts. 6.
6. Maintenance and Troubleshooting Checking The AED Status Using The AED Status Screen You may also check the status of the unit when it is off by pressing the center softkey button to enter Maintenance Mode and display the AED Status Screen. The AED Status Screen shown at left is used to provide a quick overview of the DDU-2000 Series AED’s status and to display select information without turning the unit on in AED Mode.
6. Maintenance and Troubleshooting Checking The Condition Of The Unit And Accessories Inspect the unit for dirt and contamination, especially in the pads connector socket and around the battery pack opening. (Refer to the “Cleaning” section in this chapter of this manual for guidance on cleaning your AED.) Inspect the unit display screen for damage. Look for cracks or other signs of damage on the case, especially near the connector socket.
6. Maintenance and Troubleshooting Checking Pad And Battery Pack Expiration Dates It is important to check the expiration dates of the pads and battery pack. Both may be checked when the unit is off by pressing the center softkey button to display the AED Status Screen. (Refer to the “AED Status Screen” section in Chapter 7 of this manual.
6. Maintenance and Troubleshooting 6.2 Self-Tests The DDU-2000 Series AED provides for both automatic and manually initiated self-tests. These self-tests test various components of the AED, including the system controls, battery pack condition, charge/discharge functions, and measurement and signal acquisition functions. Automatic Unit Self-Tests Every time the unit is turned on, power-on self-tests are performed to test the basic operation of the unit.
6. Maintenance and Troubleshooting 6.5 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 Unit Maintenance” section of this chapter. As each item is completed it should be checked off.
6. Maintenance and Troubleshooting 6.6 Troubleshooting The following table lists the symptoms, the possible causes, and the possible corrective actions for common problems. 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. (Refer to Chapter 13 of this manual for contact information.
Symptom Possible Cause Corrective Action Pads not connected to unit Make sure pads connector is oriented correctly and fully inserted into unit Pads connector not plugged in Plug in pads connector Pads connector broken Replace pads Unit’s connector broken Call for service Pads are beyond expiration date shown on pads package Replace pads 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 R
7 Maintenance Mode 7.1 Overview Maintenance Mode for the Defibtech DDU-2000 Series AED permits the user to perform maintenance-related actions such as viewing unit information, initiating unit self-tests, changing unit parameters, downloading rescue data, and upgrading software. Maintenance Mode is navigated through a series of screens, menus, and menu options. In Maintenance Mode, the softkey buttons located directly to the right of the display screen are used to scroll through and select menu options.
7.3 Entering Maintenance Mode Before You Begin: Make certain the DDU-2000 Series AED is turned off and a battery pack is installed. STEP 1 – Press and release the CENTER softkey button. AED status Battery status Pads status AED S/N Battery S/N Software version OK Expires 01/20xx Adult Expires 06/20xx 099999999 099999999 Vx.x Result – The unit will turn on and display the AED Status Screen for a short period of time. If the unit does not turn on, check to make sure a good battery pack is installed.
7.6 AED Maintenance Screen The AED maintenance screen allows the user to select such options as AED tests, software upgrades, data backups, and data card functions. Before you begin: Be sure the unit is in Maintenance Mode. To enter: Navigate to AED maintenance: AED Main Menu Ú AED maintenance What it does: The unit will display the AED maintenance menu screen.
To enter: Navigate to Upgrade AED: AED Main Menu Ú AED maintenance Ú Upgrade AED What it does: If an upgrade data card is present, the unit will start performing the upgrade process. Follow any prompts and instructions that the upgrade application provides. WARNING Do not turn off the unit or remove the battery pack or data card until the operation is complete. Note: If the DDC card is not inserted, the unit will speak and display “Data Card Missing.
To enter: Navigate to Format data card: AED Main Menu Ú AED maintenance Ú Format data card What it does: The unit will format the DDC card that is inserted in the AED: The unit says: “Formatting data card” The unit displays: Formatting Data Card When unit finishes formatting the DDC card, the unit will return to the menu. Do not turn off the unit or remove the battery WARNING pack or data card until the operation is complete.
What it does: The unit will display the AED options menu screen. This screen will allow the user to modify the following user changeable parameters: • • • • • System time System date Volume level Audio recording Status broadcast To exit: Using the TOP or BOTTOM softkey buttons, scroll to and highlight the selection. Go to main menu. Press the CENTER softkey button. The unit will exit the AED options menu screen and return to the AED Main Menu.
The date is now set and the user may use TOP or BOTTOM softkey buttons to navigate to other choices in the menu. Note: The factory default setting of the internal AED clock is Universal Time (GMT). Volume Level The Volume level option allows the user to set AED audio output to high, medium, or low volume. Changing the volume level will not change the volume of the Active Status Indicator “beep.” Before you begin: Be sure the unit is in Maintenance Mode.
7.8 Rescue Options Screen To manually configure rescue options such as Rescue protocol and CPR breathing, select the Rescue options from the AED Main Menu screen. Before you begin: Be sure the unit is in Maintenance Mode. To enter: Navigate to Rescue options: AED Main Menu Ú Rescue options What it does: The unit will display the Rescue options menu screen. This screen will allow the user to modify certain user changeable parameters: • CPR breathing • Rescue protocol – Settings • Default view 7.
Settings Before you begin: Be sure the unit is in Maintenance Mode. To enter: Navigate to Settings: AED Main Menu Ú Rescue options Ú Settings 7. Maintenance Mode What it does: The Settings option allows the user to change the currently enabled protocol by entering a special protocol code. This code is a special code that encodes all the important information regarding the protocol (i.e.
7.9 Help Topics Screen The Help topics option on the AED Main Menu provides a list of available help topics. Before you begin: Be sure the unit is in Maintenance Mode. To enter: Navigate to Help topics: AED Main Menu Ú Help topics What it does: The Help topics provides a list of available help topics.
8 DDU-2000 Series AED Accessories This chapter describes the component parts and accessories that can be used with the Defibtech DDU-2000 Series AED. For contact information on obtaining replacement component parts and accessories, refer to Chapter 13 in this manual. For more information about accessories, please visit www.defibtech.com or contact Defibtech or your distributor. 8.
8.5 USB Cable An optional USB cable may be used with the DDU-2000 Series AED for connecting the AED to a personal computer running Defibtech maintenance software. The AED has a mini-USB connector located on the right side of the unit behind the data card/USB port access door. Do not have a USB cable attached WARNING to the unit during a rescue. 8.
9 Event Viewing 9. Event Viewing This chapter includes information about DefibView, Defibtech Data Cards (DDC cards), and downloading internal data logs. 9.1 DefibView DefibView is a Windows-based software application that reads data stored on a DDC card or downloaded through the USB port and displays the data on a personal computer.
10 Technical Specifications 10.1 Defibtech DDU-2000 Series AED General Specification Size 7.3 x 9.5 x 2.3 inches (18.5 x 24 x 5.8 cm) Weight Less than 3 lbs (1.4 kg) (with battery) Power Battery Pack (not rechargeable) Design standards Meets applicable requirements of • IEC 60601-1 • UL 60601-1 • CAN/CSA C22.2 No.601.
Defibtech DDU-2000 Series AED (continued) Defibrillator – ECG Mode (DDU-2450 only) Category Specification Displayed ECG ECG information is received from defibrillation pads in anterior-lateral or anterior-posterior positions, or from the 3-wire ECG Monitor Adapter in Lead II Screen type TFT Color LCD with backlight (53.6mm x 71.
Defibtech DDU-2000 Series AED (continued) Waveform Specifications The DDU-2000 Series AED delivers a 150 J (Adult) 50 J (Pediatric) Biphasic Truncated Exponential waveform (AED Mode) to patients with impedances ranging from 25 to 180 ohms. V V max V1 A t 10. Technical Specifications B V min V1' The waveform is adjusted to compensate for measured patient impedance. Nominal phase times and energy delivered are shown in the tables below.
Defibtech DDU-2000 Series AED (continued) Environmental Category Operating/ Maintenance 0 – 50°C (32 – 122°F) Humidity 5% – 95% (non-condensing) One Hour Operating Temperature Limit -20°C (-4°F) (extreme cold)* Air Pressure 700 to 1060 hPa (21 to 31 inHg) Temperature 0 – 50°C (32 – 122°F) Humidity 5% – 95% (non-condensing) Air Pressure 500 to 1060 hPa (15 to 31 inHg) Altitude -150 to 4500 meters (-500 to 15,000 feet) per MIL-STD-810F 500.
Defibtech DDU-2000 Series AED (continued) Shockable Rhythm Criteria When placed on a patient meeting the indications for use criteria, the DDU-2000 Series AED is designed to recommend a defibrillation shock when it detects proper pad impedance and one of the following: Ventricular Fibrillation: Peak-to-peak amplitude at least 200 µVolts. Some very low amplitude or low frequency VF rhythms may not be interpreted as shockable.
10.2 Battery Packs Use only Defibtech battery packs in the DDU-2000 Series AED. DBP-2003 and DBP-2013 Battery Packs Category Specification Model number DBP-2003 DBP-2013 (Aviation;TSO C-142a) Main battery type 12VDC, 2800 mAh, Lithium/Manganese Dioxide. Disposable, recyclable, non-rechargeable. Capacity 125 shocks or 8 hours of continuous operation.* Charge time 4 seconds or less (from shock advised)* Standby-life (installed in unit) 4 years* 10.
10.5 Event Documentation Internal Event Record Select ECG segments and rescue event parameters are recorded and can be downloaded to a removable data card. Removable Storage (optional) Up to 30 hours of ECG and event data storage (no audio option) or up to 3 hours of audio (audio option). ECG and event storage on a removable data card. Actual length of storage is dependent on card capacity. Data card must already be installed at the time of event. 10.
11 Electromagnetic Conformity 11.1 Guidance And Manufacturer’s Declaration The essential performance of the DDU-2000 Series AED is successful delivery of defibrillation therapy and accurate differentiation between shockable and nonshockable rhythms. DDU-2000 Series AEDs are intended for use within the electromagnetic environment specified below. The customer or the user of the DDU-2000 Series AED should assure that it is used within the stated environmental specifications.
Electromagnetic Immunity (continued) IEC 60601 test level Immunity test Compliance level 20 V/m 80 MHz to 2.5 GHz Radiated RF 20 V/m IEC 61000-4-3 80% 5Hz AM Modulation Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the DDU-2000 Series, including cables, than necessary. The recommended separation distance calculated from the equation applicable to the frequency of the transmitter is shown in the following table.
Separation Distances (continued) For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: As 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
12. Glossary Of Symbols 12 Glossary Of Symbols Symbol Meaning High voltage present. SHOCK Button – Delivers defibrillation shock to the patient when the device is ready to shock. ON/OFF Button • Turns the device ON when it is OFF. • Turns the device OFF when it is ON. ! Caution, consult accompanying documents. Do not expose to high heat or open flame. Do not incinerate. Recyclable. Consult operating instructions. Refer to instruction manual / booklet. YYYY Do not damage or crush.
12. Glossary Of Symbols Glossary Of Symbols (continued) Symbol Meaning 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 YYYY- MM- DD Y Y Y Y- MM- DD Date of manufacture. YYYY-M M -DD YYYY YYYY- MM- DD YYYY Manufacturer and date of manufacture. YYYY- MM- D D YYYY-M M -DD Do not reuse. For USA users only.
13 Contacts Manufacturer Defibtech, L.L.C. 741 Boston Post Road, Suite 201 Y Y Y Y- M M -D D Y Y Y-M M -D D Guilford, CT Y06437 USA Tel.: 1-(866) 333-4241 (Toll-free within North America) 1-(203) 453-4507 Fax: 1-(203) 453-6657 Email: sales@defibtech.com reporting@defibtech.com service@defibtech.com (Sales) (Medical Device Reporting) (Service and Repair) 13.
