Defibtech DDU-2000 Series Automated External Defibrillator • • • DDU-2300 DDU-2400 DDU-2450 User Manual DAC-E2510EN-BB AHA / ERC 2010 ELECTRONIC DISTRIBUTION
PRESS “ON” BUTTON 1 APPLY PADS FOLLOW AED INSTRUCTIONS 2 IF INSTRUCTED, PRESS “SHOCK” BUTTON 3 B 2 DAC-E2510EN-BB
Notices Defibtech, LLC 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 2 Introduction To The DDU-2000 Series AED.......................................................6 1.1 Overview............................................................................................................................ 6 1.2 The Defibtech DDU-2000 Series AED................................................................................ 8 1.3 Indications........................................................................................................................
7 8 Maintenance And Troubleshooting..................................................................32 7.1 Routine Unit Maintenance................................................................................................ 32 7.2 Self-Tests.......................................................................................................................... 36 7.3 Cleaning.........................................................................................................................
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 Semi-Automatic External Defibrillator (AED) and its accessories. This chapter includes intended use, an overview of the AED, a discussion of when it should and should not be used, and information on operator training. 1.
1. Introduction Defibrillation energy is delivered as an impedance compensated biphasic truncated exponential waveform. In AED Mode, the device delivers 150 Joules of defibrillation energy (into a 50-ohm load) when using adult defibrillation pads and 50 J of defibrillation energy (into a 50-ohm load) when using child/infant pads (also known as pediatric defibrillation pads). Energy delivered does not change significantly with patient impedance, although the duration of the generated waveform will vary.
1.2 The Defibtech DDU-2000 Series AED K. Unit Serial Number. The unit’s serial number can be found on the back of the AED, above the battery pack opening. B. SHOCK 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. M. Battery Pack Eject Release Latch. This release latch releases the battery pack from the DDU-2000 Series AED. C. D isplay Screen.
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 U. ECG Monitoring Adapter (optional; DDU-2400/2450 only) K. Unit Serial Number L. Battery Pack Opening M. B attery Pack Eject Release Latch N. Pad Storage Area O. Pads Connector BACK OF AED S. Battery Pack P. Defibrillation Pads Q.
1.3 Indications 1. Introduction The DDU-2000 Series Semi-Automatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are: • Unconscious and unresponsive • Not breathing For patients under 8 years old or less than 55 pounds (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight. 1.
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) • Aggressive or prolonged CPR to a patient with defibrillation pads attached can cause damage to the pads. Replace the defibrillation pads if they become damaged during use. • Possible Radio Frequency (RF) interference from RF devices such as cellular phones and two-way radios can cause improper AED operation. Normally using a cell phone near the AED should not cause a problem; however, a distance of 2 meters (6 feet) between RF devices and the DDU-2000 Series AED is recommended.
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.
Connecting The Defibrillation Pads (continued) Insert the connector end of the defibrillation pad cable into the pads connector socket on the top-left corner of the DDU-2000 Series AED as shown. Insert pads connector firmly until it is fully seated in the unit. The connector will only fit in one way – if the connector does not fit, rotate the connector before trying again. The connected pads package can then be stored in the pad storage slot in the back of the DDU-2000 Series AED.
3.4 Installing And Removing The Battery Pack The battery pack provides power to the DDU-2000 Series AED. Do not install the battery pack after the expiration date printed on the label. The battery pack is non-rechargeable. Before inserting the battery pack into the DDU-2000 Series AED, ensure that the battery pack opening in the back of the AED is clean and clear of any foreign objects. Insert the battery pack into the opening in the back of the AED. Push the pack all the way in until the latch clicks.
Checking The DDU-2000 Series AED Status (continued) AED status Battery status Pads status AED S/N Battery S/N Software version OK Expires 01/2018 Adult Expires 06/2018 099999999 099999999 V2.2 To check the status of the AED when the unit is off, press the center softkey button. The display screen will show unit status, battery pack status, and pad status. After a short period of time, the display screen, and the unit will turn off. AED Status screen 3.
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. The DDU-2000 Series AED was designed for simple operation, allowing the operator to focus on the patient. There are two primary control buttons and 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-2400/2450 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-2400/2450 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 Apply pads correctly to patient. Follow AED voice and text prompts. Correct pad placement is essential for effective analysis of the patient’s cardiac rhythm and subsequent shock delivery (if required). Remove the pads from the pads package by tearing the package along the dotted line near the top of the package.
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 7 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 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 DDU-2000 Series AED will give this prompt and immediately go to CPR mode.
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 Manual Mode (DDU-2400 only) The DDU-2400 AED provides a Manual Mode to override the AED features of the defibrillator. Manual Mode provides an ECG display of patient’s rhythm as well as operator-initiated charge, shock, and disarm functions. Manual Mode should only be used by qualified medical personnel trained in advanced life support skills and ECG recognition who want to deliver a shock independent of AED Mode.
5.3 Selecting Energy The user may select the desired energy level by pressing the softkey associated with the Energy Select Icon (upper button). The default energy when entering Manual Mode is always 150 J (adult pads) or 50 J (pediatric pads).
6 ECG Monitor Mode (DDU-2400/2450 only) At the discretion of emergency care personnel, the DDU-2400 and 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.
6.3 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.
7. Maintenance And Troubleshooting 7 Maintenance And Troubleshooting This chapter describes the maintenance and troubleshooting procedures for the DDU-2000 Series AED. The self-tests that are performed by the device are described along with the frequency and nature of routine maintenance for which the owner/operator is responsible. A troubleshooting guide is provided to help diagnose user serviceable problems. The DDU-2000 Series AED contains no user serviceable parts. 7.
7. 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 is used to provide a quick overview of the DDU2000 Series AED’s status and to display select information without turning the unit on in AED Mode.
7. 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.
7. Maintenance And Troubleshooting Checking Pad And Battery Pack Expiration Dates It is important to check the expiration dates of the pads and battery pack. The expiration date of the pads package is printed on the outside of the sealed package. The expiration date of the battery pack is printed on the label on the battery pack. Once an accessory is past its expiration date, it should be taken out of service and replaced as soon as possible.
7. Maintenance And Troubleshooting 7.2 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.
7. Maintenance And Troubleshooting 7.5 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.
7. Maintenance And Troubleshooting 7.6 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 14 of this manual for contact information.
7.
8 Maintenance Mode 8.1 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.
8.3 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 01/2018 Adult Expires 06/2018 099999999 099999999 V2.2 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.
8.6 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 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.
CPR Breathing The CPR breathing option allows the user to enable or disable the CPR breathing coaching prompts during CPR. Before you begin: Be sure the unit is in Maintenance Mode. To enter: Navigate to CPR breathing: AED Main Menu Ú Rescue options Ú CPR breathing What it does: CPR breathing allows the user to enable/disable CPR breathing coaching prompts. Use the TOP and BOTTOM softkey buttons to select the desired mode.
Default View (DDU-2400/2450 only) The Default view option allows the user to select Video or ECG as the default view when the AED is powered. Before you begin: Be sure the unit is in Maintenance Mode. To enter: Navigate to Default view: AED Main Menu Ú Rescue options Ú Default view What it does: Selects which view the AED presents on power up. Use the TOP and BOTTOM softkey buttons to select the desired view. When the desired selection is chosen, press the CENTER softkey button to set the feature.
9 DDU-2000 Series AED Accessories This chapter describes the component parts and the 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 14 in this manual. 9.1 Defibrillation Pads The DDU-2000 Series AED must be used with Defibtech self-adhesive defibrillation pads for adults or with child/infant pads for infants and children.
9.4 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. 9.
Event Viewing 10. Event Viewing 10 This chapter includes information about DefibView, Defibtech Data Cards (DDC cards), and downloading internal data logs. 10.1 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.
11 Technical Specifications 11.1 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 – Manual Mode (DDU-2400 only) Category Specification Energy User selectable: 25, 50, 70, 100, 150, 200 Joules (adult defibrillation pads) 25, 50, 70, 100, Joules (pediatric defibrillation pads) Note: energy is limited to 50 J only, when using DDP-2002 (attenuating pediatric defibrillation pads) Charge control User initiated, CHARGE softkey Charge time See battery charge time specifications in Section 11.
Defibtech DDU-2000 Series AED (continued) Waveform Specifications In AED Mode, 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. In Manual Mode, the user can select the energy level. V V max V1 A 11. Technical Specifications t 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) Energy – Manual Mode (DDP-2001 Adult and DDP-2003 Non-attenuating Pediatric Defibrillation Pads) (Nominal) Load Impedance (Ohms) 25 50 75 100 125 150 175 25 J 25 25 26 26 26 25 25 50 J 50 50 51 51 51 50 49 70 J 70 70 71 71 72 70 68 100 J 99 100 101 101 102 100 97 150 J 153 151 152 151 153 146 142 200 J 194 195 198 197 201 195 189 11.
Defibtech DDU-2000 Series AED (continued) Environmental Category Operating/ Maintenance Standby/Storage/ Transport Specification Temperature 0 – 50°C (32 – 122°F) Humidity 5% – 95% (non-condensing) 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) -150 to 4500 meters (-500 to 15,000 feet) per MIL-STD-810F 500.4 Procedure II Shock/Drop Abuse Tolerance MIL-STD-810F 516.
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.
11.2 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.
11.5 Event Documentation Internal Event Record Critical ECG segments and rescue event parameters are recorded (greater than 60 minutes) 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. 11.
12 Electromagnetic Conformity 12.1 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 10 V/m 80 MHz to 2.5 GHz Radiated RF 10 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.
13. Glossary Of Symbols 13 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. YYYY Refer to instruction manual / booklet. YYYY Do not damage or crush.
13. Glossary Of Symbols Glossary Of Symbols (continued) Symbol Meaning Manufacturer. YYYY YYYY YYYY YYYY YYYY Date of manufacture. 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. Transportation and storage requirements. See environmental requirements. LATEX Does not contain latex. Lot number.
14 Contacts Manufacturer Defibtech, L.L.C. 741 Boston Post Road Guilford, CT 06437 USA YYYY YYYY 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) 14. Contacts Patents pending. This product and its accessories are manufactured and sold under one or more of the following United States patents: D523,393, D548,346, D551,628.