Table of Contents
Troubleshooting
Related Manuals for Defibtech DDU-2200
Summary of Contents for Defibtech DDU-2200
- Page 1 Defibtech DDU-2200 Fully-Automatic External Defibrillator User Manual For comprehensive training on set-up, use and maintenance; source for complete technical specifications ELECTRONIC DISTRIBUTION DAC-E2512EN-BB...
- Page 2 PRESS “ON” BUTTON APPLY PADS FOLLOW AED INSTRUCTIONS DAC-E2512EN-BB...
- Page 3 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.
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Page 4: Table Of Contents
3.3 Installing and Removing the Battery Pack ............... 14 3.4 Checking the DDU-2200 AED Status ................15 3.5 Installing the Defibtech Data Card (DDC Card) (optional) ..........16 3.6 Completing the Installation ..................... 16 3.7 Storing the DDU-2200 AED ..................... 16 Using the DDU-2200 AED ................17... - Page 5 7 .4 USB Cable ........................45 Event Viewing ....................46 8.1 DefibView ........................46 8.2 Defibtech Data Cards (DDC Cards) ................. 46 8.3 Downloading the Internal Data Log ................. 46 Technical Specifications ..................47 9.1 Defibtech DDU-2200 AED ....................47 9.1.1 General ........................47 9.1.2 Defibrillator ......................
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Page 6: Introduction To The Ddu-2200 Aed
The DDU-2200 AED determines proper pad-to-patient contact by measuring the impedance between the two pads. The DDU-2200 AED user interface is clear and concise. It has push-button controls and a display screen. Easily understandable voice messages and text and video prompts guide the operator through the use of the unit. The device communicates the status of the AED and of the patient to the operator. -
Page 7: The Defibtech Ddu-2200 Aed
1.2 The Defibtech DDU-2200 AED A. Speaker. The speaker projects the voice I. Defibtech Data Card (DDC card). prompts when the DDU-2200 AED is on. The This optional plug-in card provides enhanced speaker also emits a “beep” when the unit is storage capabilities to the AED. - Page 8 B. SHOCK Required Indicator H. USB Port A. Speaker I. Defibtech Data Card (DDC Card) (optional) J. USB and Defibtech Data Card (DDC Card) Access Door FRONT OF AED K. Battery Pack L. Battery Pack Opening Eject Release Latch M. Pad Storage Area N.
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Page 9: Usage
Contraindications None. Operator Training Requirements In order to safely and effectively operate the DDU-2200 AED, a person shall have met the following requirements: • Defibtech DDU-2200 AED and/or defibrillation training as required by local, state, provincial, or national regulations. • Any additional training as required by the authorizing physician. -
Page 10: Warnings And Cautions
50°C (122°F). Remove battery when depleted. • Do not let fluids get into the DDU-2200 AED. Avoid spilling fluids on the AED or its accessories. Spilling fluids into the DDU-2200 AED may damage it or cause a fire or shock hazard. - Page 11 • 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. • Do not connect the DDU-2200 AED to a PC or other device (using the USB port) while the unit’s electrodes are still connected to the patient.
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Page 12: Cautions
• Recycle or dispose of lithium battery packs in accordance with local, state, provincial, and/or national regulations. To avoid fire and explosion hazard, do not burn or incinerate the battery pack. Do not crush. • Use and store the DDU-2200 AED only within the range of environmental conditions specified in the technical specifications. -
Page 13: Setting Up The Ddu-2200 Aed
Setting Up the DDU-2200 AED This chapter describes the steps required to make your Defibtech DDU-2200 AED operational. The DDU-2200 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 14: Connecting The Defibrillation Pads
AED and battery pack are ready for use. If the indicator flashes red, is solid red, or there is no flashing light, the AED requires service (refer to Section 3.4, “Checking the DDU-2200 AED Status” , for more details on the meaning of the indicator). -
Page 15: Checking The Ddu-2200 Aed Status
Active Status Indicator (ASI) Once a fully-functional battery pack is installed in the DDU-2200 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. -
Page 16: Installing The Defibtech Data Card (Ddc Card) (Optional)
The Active Status Indicator (ASI) should periodically fl ash with a green light. If it fl ashes with a red light or does not fl ash at all, the DDU-2200 AED needs servicing (refer to Section 3.4, “Checking the DDU-2200 AED Status” , for more information). -
Page 17: Using The Ddu-2200 Aed
Using the DDU-2200 AED This chapter describes how to use the DDU-2200. During a rescue, the unit analyzes the patient’s rhythm and automatically charges if a shockable rhythm is detected. Push-button controls and indicators include an ON/OFF button, three softkey buttons, and a SHOCK Required LED indicator. The unit includes a display screen. Concise and easily understandable voice messages and text and video prompts guide the operator through the use of the unit. -
Page 18: Preparation
Turning On the DDU-2200 AED Press the green ON/OFF button to turn the DDU-2200 AED on. The unit will emit a “beep” and the display screen will turn on. The ASI indicator next to the ON/OFF button will illuminate green anytime the AED is on. (To turn the unit off, press AND HOLD the ON/OFF button for approximately two seconds;... - Page 19 AED and connect the pediatric pads (see the “Connecting the Defi brillation Pads to the DDU-2200 AED” section above for details). Do not delay therapy to determine exact age or weight. If pediatric pads are not available, apply adult pads in the position for a child/infant as shown in the “Applying the Defi brillation Pads to the Patient”...
- Page 20 Using the DDU-2200 AED (continued) Applying the Defi brillation Pads to the Patient Follow this procedure to apply the defi brillation pads to the patient: 1. Tear the defi brillation pads package along the dotted line near the top of the package.
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Page 21: Heart Rhythm Analysis
Follow DDU-2200 AED Instructions At this point, the DDU-2200 AED will check to make sure that the pads are well connected to the patient and that an ade- quate ECG signal is being received. Do not touch the patient. Eliminate any patient movement, and cease CPR at this time. -
Page 22: Post-Use Procedures
Call for Help Purpose: As soon as the DDU-2200 AED is turned on, the user will be prompted 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. - Page 23 Apply Pads to Patient Purpose: The DDU-2200 AED has determined that the pads are not placed on the patient or not properly applied. Place pads on the patient following instructions on the pads package. If the prompts continue, try replacing the pads with a new set.
- Page 24 “Analyzing” Analyzing Purpose: The DDU-2200 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. “Do not touch the patient”...
- Page 25 OK to Touch Patient Purpose: The DDU-2200 AED has determined that a shock is not required. The unit will not charge or automatically deliver the shock. If the AED is charged, the shock will be canceled. The user will be prompted to begin CPR.
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Page 26: Operational Environment
4.8 Operational Environment The Defibtech DDU-2200 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 Section 9.1.4 of this manual (“Environmental”) for a detailed list of approved environmental conditions. -
Page 27: Maintenance And Troubleshooting
“Contacts” section in Chapter 12 of this manual). If the ASI is fl ashing red, turn the DDU-2200 AED on. If the unit does not turn on or does not speak, the AED is non- operational and requires servicing. If the unit does turn on, then turn the unit off and the voice prompts will indicate the nature of the problem. - Page 28 “Service code ‘xxxx’ ” Service Code “xxxx” Purpose: The DDU-2200 AED will report this message when it powers off, indicating a service code that was previously detected. “Service required”...
- Page 29 The DDU-2200 AED defi brillation pads are supplied in a sealed pouch with the connector and part of the cable exposed. The DDU-2200 AED is designed to be stored with the electrode cable already installed. This allows the pads to be stored in a pre-connected state for rapid deployment during an emergency.
- Page 30 Checking the Defi btech Data Card (DDC Card) Each time the DDU-2200 AED is used, an event fi le is created on the Defi btech Data Card (DDC card), if installed. If the unit was used to treat a patient, the DDC card in the unit should be removed and provided to the patient’s care provider.
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Page 31: Self-Tests
Note: Running a manually-initiated self-test will consume approximately one shock’s worth of energy from the battery. 5.3 Cleaning After each use, clean the DDU-2200 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: •... -
Page 32: 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 recommended by the schedule in the “Routine Unit Maintenance” section of this chapter. As each item is completed it should be checked off. Defibtech DDU-2200 AED Operator’s Checklist Defibtech DDU-2200 AED Serial Number: ___________________________________________________... -
Page 33: Troubleshooting
5.6 Troubleshooting The following table lists the symptoms, the possible causes, and the possible corrective actions for common problems. Refer to the other sections of this 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 12 of this manual for contact information). -
Page 34: Repair
“ Replace data card” prompt DDC card has failed Replace DDC card 5.7 Repair The DDU-2200 AED contains no user serviceable parts. If the unit needs servicing, call Defibtech (refer to Chapter 12 of this manual for contact information). DAC-E2512EN-BB... -
Page 35: Maintenance Mode
Maintenance Mode 6.1 Overview Maintenance Mode for the Defi btech DDU-2200 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. -
Page 36: Entering Maintenance Mode
6.3 Entering Maintenance Mode Before You Begin: Make certain the DDU-2200 AED is turned off and a battery pack is installed. STEP 1 – Press and release the CENTER softkey button. AED status Result – The unit will turn on and display the AED Status Screen for a short period of time. -
Page 37: Aed Maintenance Screen
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... - Page 38 Transfer Data To Card Transfer data to card will initiate a data transfer from the DDU-2200 AED to a Defibtech Data Card (DDC card) inserted in the device. Internal event data and device history is written to the DDC card.
- Page 39 Note: Formatting the data card will erase all existing data on the data card. Before you begin: Be sure the unit is in Maintenance Mode. Be sure a Defibtech Data Card (DDC card) is currently installed in the device (refer to the “Installing the Defibtech Data Card (DDC Card)”...
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Page 40: Aed Options Screen
Note: If a data card is not inserted, the unit will speak and display “Data Card Missing” (refer to the “Installing The Defibtech Data Card (DDC Card)” section in Chapter 3 of this manual). To exit: When the unit finishes performing the application, follow the displayed and spoken instructions. - Page 41 Audio Recording The Audio recording option allows the user to enable or disable recording of event audio data to a Defibtech Data Card (DDC card). Before you begin: Be sure the unit is in Maintenance Mode. To enter: Navigate to Audio recording: AED Main Menu Ú...
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Page 42: Rescue Options Screen
Status Broadcast The Status broadcast option allows the user to enable or disable wireless (RF) transmission of status data to an optional data receiver (contact your Defibtech distributor for details). Before you begin: Be sure the unit is in Maintenance Mode. -
Page 43: Help Topics Screen
CPR cycles, and number of shocks between CPR). This code is custom generated by Defibtech. If the code is not entered correctly the protocol will not be changed. Based on the protocol code entered, the currently selected protocol will be changed to that described by the special protocol code. -
Page 44: Ddu-2200 Aed Accessories
7.2 Battery Packs The DDU-2200 AED uses a lithium battery pack to provide the AED with a long shelf and standby life. The battery pack is inserted into the battery pack opening on the back of the AED and latches into place. Standard battery packs (discernible by their yellow plastic casing) are not rechargeable. -
Page 45: Usb Cable
7.4 USB Cable An optional USB cable may be used with the DDU-2200 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. -
Page 46: Event Viewing
CAUTION 8.2 Defibtech Data Cards (DDC Cards) If a DDC card is installed in the unit, every time the DDU-2200 AED is turned on, the following information is recorded on a new file on the card: • The time the AED was turned on. -
Page 47: Technical Specifications
Technical Specifications 9.1 Defibtech DDU-2200 AED 9.1.1 General Category 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) Meets applicable requirements of •... -
Page 48: Waveform Specifications
Defibtech DDU-2200 AED (continued) 9.1.3 Waveform Specifications The DDU-2200 AED delivers a 150 J (Adult) 50 J (Pediatric) Biphasic Truncated Exponential waveform to patients with impedances ranging from 25 to 180 ohms. V max V min The waveform is adjusted to compensate for measured patient impedance. -
Page 49: Environmental
8 and 16 kHz sine waves at 74 uA peak-to-peak maximum current are applied to the patient. The DDU-2200 Patient Analysis System ensures that the patient impedance is within the proper range and analyzes the patient’s ECG rhythm to determine whether a shock is required. On detection of a non-shockable rhythm, the user is prompted to perform CPR. -
Page 50: Shockable Rhythm Criteria
Defibtech DDU-2200 AED (continued) 9.1.5.1 Shockable Rhythm Criteria When placed on a patient meeting the indications for use criteria, the DDU-2200 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. - Page 51 Philips AEDs or 200 to 360J monophasic waveform AEDs on victims where defibrillation was indicated. As noted above, the data provided by Defibtech demonstrates that the waveforms from Philips and Defibtech are almost identical. Therefore, the clinical data for adult defibrillation included in the Schneider publication was leveraged to support the safety and effectiveness of the Defibtech waveform.
- Page 52 As with the adult Defibtech defibrillation waveform, the data provided by Defibtech demonstrates that the pediatric waveforms from Philips and Defibtech are almost identical. The Tang animal study tested the defibrillation waveform used for defibrillation success and safety on a pediatric model (swine).
- Page 53 Technology-Beth Israel Hospital, Malignant Ventricular Arrhythmia), MIT-BIH SVA (Massachusetts Institute of Technology-Beth Israel Hospital, Supraventricular Arrhythmia), CU VT (Creighton University, Ventricular Tachyarrhythmia), AHA (American Heart Association, Ventricular Arrhythmia), and Defibtech’s internal library of real-life and electronically-manipulated ECG recordings. The Defibtech AEDs meet the recommendations of the AHA and IEC 60601-2-4 for performance goals of arrhythmia analysis algorithms.
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Page 54: Potential Adverse Effects Of The Device On Health
Defibtech DDU-2200 AED (continued) References (as shown throughout “Summary of Primary Clinical Studies” section) 1 Thomas Schneider, Patrick R. Martens, Hans Paschen, Markku Kuisma, Benno Wolcke; Bradford E. Gliner, James K. Russell, W. Douglas Weaver, Leo Bossaert, Douglas Chamberlain, for the Optimized Response to Cardiac Arrest (ORCA) Investigators. -
Page 55: Battery Packs
9.5 Event Data As part of Defibtech’s on-going regulatory compliance activities, event data shared with Defibtech may be used by Defibtech to fulfill regulatory obligations. Any identifying personal data or health information received is considered confidential within Defibtech and will not be used for any other purpose. -
Page 56: Defibtech Event Viewer
9.7 Recycling Information At the end of useful life, recycle the defibrillator and its accessories. Recycling Assistance For recycling assistance contact your local Defibtech distributor. Recycle in accordance with local and national regulations. Preparation For Recycling Items should be clean and contaminant-free prior to being recycled. -
Page 57: Electromagnetic Conformity
The DDU-2200 AED is intended for use within the electromagnetic environment specified below. The customer or the user of the DDU-2200 AED should assure that it is used within the stated environmental specifications. ELECTROMAGNETIC EMISSIONS... - Page 58 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DDU-2200 AED is used exceeds the applicable RF compliance level above, the DDU-2200 AED should be observed to verify normal operation.
- Page 59 WARNING Regulatory Compliance Changes or modifications of this product, not expressly approved by Defibtech, may void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules and Industry Canada Radio Standard RSS-210. Operation is...
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Page 60: Glossary Of Symbols
Glossary of Symbols Symbol Meaning High voltage present. SHOCK Required Indicator – Flashes to indicate that a shock is about to be delivered. auto ON/OFF Button • Turns the device ON when it is OFF . • Turns the device OFF when it is ON. Caution, consult accompanying documents. - Page 61 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. Y YY Y-MM-DD Y Y Y Y- MM -D D Y Y Y Y Y Y Y Y Date of manufacture.
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Page 62: Contacts
Contacts Manufacturer Defibtech, L.L.C. 741 Boston Post Road, Suite 201 Guilford, CT 06437 USA Y Y Y Y- M M -D D Y Y Y Y- MM -D D Tel.: 1-(866) 333-4241 (Toll-free within North America) 1-(203) 453-4507 Fax: 1-(203) 453-6657 Email: sales@defibtech.com...
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