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User Manual Defibtech DDU-2000 Series

1. 5 4 Initiating Charge To initiate charging press the softkey associated with the CHARGE Softkey Icon middle button The AED s main screen will display a progress bar and produce an audible rising tone while charging The CHARGE Softkey Icon will change to the DISARM Softkey Icon 00 01 30 200d PALL PDAS PAS lt DISARM Softkey Icon Charging Charging Screen While charging pressing the softkey associated with the DISARM Softkey Icon middle button will cancel the charge 5 5 Delivering The Shock When charging is complete the AED will prompt the user to press the flashing SHOCK button and will produce a two toned audible alarm The user should follow the AED s onscreen text instructions and press the flashing SHOCK button Note If the SHOCK button is not pressed within 30 seconds the AED will automatically disarm IMPORTANT The DDU 2000 Series AED will not automatically deliver a shock the user must press the flashing SHOCK button 00 00 20 200d Seren eee A NASAAN LVN V UAA V Vr of The user can abort charging or shock delivery at any time while Manual Mode in Manual Mode by pressing the DISARM softkey middle button Press SHOCK Button or by pressing and holding down the AED s ON OFF button for approximately two seconds to turn the unit off Shock Delivery Screen 29 DAC E2510EN BA 6 ECG Monitor Mode DDU 2400 2450 only At the discretion of em
2. System Time The System time option allows the user to set the time of the internal AED clock Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to System time AED Main Menu gt AED options gt System time What it does The System time option allows the user to set the time of internal AED clock using the 24 hour clock Once the System time option is selected press the CENTER softkey button to enter set time mode The hours selection will be highlighted green e Press the TOP or BOTTOM softkey buttons to adjust the hours to the desired time e Press the CENTER softkey button to accept the hours setting The minutes selection will be highlighted green e Press the TOP or BOTTOM softkey buttons to adjust the minutes to the desired time e Press the CENTER softkey button to accept the minutes setting The seconds selection will be highlighted green e Press the TOP or BOTTOM softkey buttons to adjust the seconds to the desired time e Press the CENTER softkey button to accept the seconds setting The time 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 System Date E The System date option allows the user to set the date of the internal AED clock Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to System date AED Ma
3. Video Mode _ gt O lt Manual Mode Softkey when in Mode of Operation DDU 2400 only ETETE OT AED ECG Mode When Manual Mode is entered the main screen automatically switches to ECG view and text prompts provide instruction NOTE Voice prompts are disabled while in Manual Mode f the pads are not applied the display will show a dashed ECG and prompt the user to apply the pads When the pads are applied the display shows the patient s ECG and heart rate Mode of Operation screen 00 00 58 00 00 12 I Energy Select Softkey Icon zeg Initiate Charge JALAL 4 Softkey Icon Manual Mode Manual Mode gem Mode Select Apply Pads to Patient LS ABTEI AE Softkey Icon Manual Mode unapplied pads Manual Mode pads applied 5 2 Exiting Manual Mode To exit Manual Mode press the softkey associated with the Mode Select Icon and select a mode of operation 28 DAC E2510EN BA 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 Pressing the Energy Select Icon will cycle the energy through the following options e 25 50 70 100 150 200 Joules Adult pads attached e 25 50 70 100 Joules Pediatric non attenuating pads attached e 50 Joules not selectable Pediatric attenuating pads attached
4. 200 Joules adult defibrillation pads Energy 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 See battery charge time specifications in Section 11 2 of this manual are e SHOCK button flashing Charge complete indication e Two tone alarm Shock delivery Shock is delivered by a single SHOCK button e Within 30 seconds after charge complete if operator has not pressed SHOCK button Automatic or DISARM e f defibrillation pads are removed from patient or unplugged from unit e f operator presses the manual DISARM softkey or ON OFF button pressed for Manual greater than 2 seconds Defibrillator ECG Mode DDU 2400 amp DDU 2450 only Displayed ECG ECG information is received from defibrillation pads in anteriorlateral or pray anteriorposterior positions or from the 3 wire ECG Monitor Adapter in Lead II TET Color LCD with backlight 53 6mm x 71 5mm 320 x 240 pixels Sweep Speed Frequency Response 1 Hz to 22 Hz 3 dB nominal Seele nominal 20 to 200 bpm updated once second Heart rate display e Displayed when ECG viewing is enabled e An out of range heart rate is indicated by dashed lines in the display Note The ECG Display provides non diagnostic ECG of the patient s heart rhythm It is not intended to provide diagnostic or ST segment interpretation Note The EC
5. Important The DDU 2000 Series AED will not automatically deliver a shock the user must press the flashing SHOCK button If while waiting for the SHOCK button to be pressed the unit detects a rhythm change to a non shockable rhythm the unit will cancel the shock Also if the SHOCK button is not pressed within 30 seconds of the initial press flashing SHOCK button prompt the unit will automatically cancel the shock The user can abort charging or shock delivery at any time by pressing and holding the ON OFF button for approximately two seconds to turn the unit off 4 5 CPR Period The operator will be prompted to begin CPR The unit will not monitor the patient s ECG rhythm during the CPR period During the CPR period the AED will not advise the user to stop motion even if motion is present The user should follow the AED instructions during this time Once the CPR period is complete the unit will continue in Heart Rhythm Analysis mode CPR coaching is provided through a series of voice and visual prompts and audible tones The factory default setting provides prompts for chest compressions only no breathing However breathing prompts can be enabled disabled by pressing the softkey button next to the Rescue Breathing Options icon displayed on the screen during rescue Refer to the Rescue Breathing Options Softkey Icon section below Breathing prompts can also be enabled disabled by setting the menu option in Maint
6. W d 1 2 P d 2 3V P 61 DAC E2510EN BA 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 VV according to the transmitter manufacturer Note 1 As 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Note A These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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
7. electrodes or pads to monitor ECG signals and if necessary to deliver defibrillation energy to the patient These pads are provided in a single use disposable package The DDU 2000 Series AED determines proper pad to patient contact by measuring the impedance between the two pads impedance varies with the electrical resistance of the patient s body The DDU 2000 Series AED user interface is clear and concise It has two primary 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 In Manual Mode additional functions are provided through the three softkeys to the right of the display 6 DAC E2510EN BA 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 In Manual Mode the DDU 2400 only offers user selected energy levels from 25 to 200 Joules Defibrillation and AED operating power is supplied by a replaceable non recharge
8. hazards or unsafe practices that may result in serious personal injury or death e Improper use can cause injury Use the DDU 2000 Series AED only as instructed in the User Manual The DDU 2000 Series AED delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly e Improper maintenance can cause the DDU 2000 Series AED not to function Maintain the DDU 2000 Series AED only as described in the User Manual The AED contains no userserviceable parts do not take the unit apart e No modification of this equipment is allowed e Electrical Shock Hazard Dangerous high voltages and currents are present Do not open unit remove cover or back or attempt repair There are no user serviceable components in the DDU 2000 Series AED Refer servicing to qualified service personnel e Lithium battery packs are not rechargeable Any attempt to recharge a lithium battery pack may result in fire or explosion e Do not immerse battery pack in water or other liquids Immersion in fluids may result in fire or explosion e Do not let fluids get into the DDU 2000 Series AED Avoid spilling fluids on the AED or its accessories Spilling fluids into the DDU 2000 Series AED may damage it or cause a fire or shock hazard e Do not sterilize the DDU 2000 Series AED or its accessories e Use only Defibtech disposable self adhesive defibrillation pads battery packs and other accessories supplied by Defi
9. 2000 Series has passed the most recent self test scheduled or user initiated If the unit needs service the ASI will flash red Anytime the ASI flashes red the unit will also beep periodically to call attention to itself The ASI also uses a distinct flash pattern to assist people with color blindness green will flash a single flash and red will flash a double flash The ASI is powered by the battery pack If the battery pack has been completely discharged or is not installed in the unit the active status indication will be off In this case immediately replace the battery pack or reinsert it into the unit to restore active status indication Flashing Green The DDU 2000 Series AED is OFF and ready for use Solid Green The DDU 2000 Series AED is ON and ready for use Flashing or Solid Red The DDU 2000 Series AED needs immediate service Refer to the Troubleshooting section in Chapter 7 of this manual or call Defibtech for service Active Status No Flashing Light The DDU 2000 Series AED needs immediate service Refer to the Indicator Troubleshooting section in Chapter 7 of this manual or call Defibtech for service ASI 15 DAC E2510EN BA Checking The DDU 2000 Series AED Status continued To check the status of the AED AED status when the unit is off press the center softkey button The display Battery status screen will show unit status battery Expires 01 2017 pack status and pad status After eut
10. 210 Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 This device must accept any interference received including interference that may cause undesired operation This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help CE Marking And European Union Compliance Radio Transmitter Defibtech LLC declares that the DDU 2000 Series AED radio transmitter is in compliance with the essential re
11. 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 pads if any nicks cuts or broken cables are found STEP 2 Connect The Pads To The Unit 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 Press the pads connector in firmly until it is fully seated in the unit STEP 3 Store The Pads In Back Of Unit The pads package can then be stored in the pad storage slot in the back of the DDU 2000 Series AED After connecting the pads connector to the unit push the pads package rounded end first with the pictures on the package facing up and out into the pad holder compartment on the back of the AED When the pads package 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 pads package The defibrillation pads are intended for one time use only and must be discarded after use or if the package has WARNING been opened 34 DAC E2510EN BA 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 accesso
12. 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 Make sure that the pads are not touching each other If the pads are not sticking due to moisture dry the patient If the pads are not sticking due to excessive hair shave or clip excessive chest hair If the prompts continue try replacing the pads with a new set Motion Interference Prompts Stop motion Stop Motion Purpose The DDU 2000 Series AED has detected possible motion in the patient Stop all patient motion including CPR in response to this prompt Stop interference Stop Interference Purpose The DDU 2000 Series AED has detected interference on the ECG signal Eliminate any radio or electrical sources of interference Check the pads to make sure they are adhering properly to the patient If the environment is very dry minimize movement around the patient to reduce static discharges Pausing for CPR Pausing for CPR Purpose The user should stop attempting to resolve motion and or interference problems and assess the condition of the patient The user will be prompted to begin CPR 24 DAC E2510EN BA Heart Rhythm Analysis Prompts Analyzing heart rhythm Analyzing Rhythm Analyzing Analyzing Purpose The DDU 2000 Series AED is actively analyzing the patient s ECG signal The AED will continue analyzing until it has determined whe
13. connection Replace pads Check that pads are placed securely on patient Check pads prompt Pads touching Separate pads and place correctly on patient Stop motion prompt Stop interference prompt Patient motion has been detected External interference has been detected Stop patient motion Stop external interference Analyzing interrupted prompt Motion or interference detected Stop motion or interference Shock cancelled prompt Patient s ECG rhythm changed No action necessary Shock button not pressed within 30 seconds Press shock button within 30 seconds Low battery insufficient to charge Replace battery pack Bad pad to patient connection Check that pads are placed securely on patient Dry pads Replace pads Replace data card prompt DDC card is full Replace DDC card with a card that is not full DDC card has failed Replace DDC card Pads missing prompt 7 7 Repair Pads not connected to unit Make sure pads connector is oriented correctly and fully inserted into unit The DDU 2000 Series AED contains no user serviceable parts If the unit needs servicing call Defibtech Refer to Chapter 14 of this manual for contact information 39 DAC E2510EN BA 8 Maintenance Mode 8 1 Overview Maintenance Mode for the Defibtech DDU 2000 Series AED permits the user to perform maintenance r
14. data is not logged internally Downloading The Internal Data Log Using The DDC Card To download the internally logged information perform the following procedure e Insert a DDC card into the unit e Turn the unit on in Maintenance Mode by pressing the center softkey button e Press the tool icon to enter the AED Maintenance screen e From the AED Maintenance screen select the Transfer Data To Card option Allow the unit to write the contents of the internal log to the DDC card The DDU 2000 Series AED will write the contents of the internal log onto the DDC card This information can then be reviewed using DefibView software Downloading The Internal Data Log Using The USB Port To download the internal data log using the USB port in the unit connect a USB cable between the unit and a PC Launch the Defibview software and follow USB download directions 51 A Do not operate the DDU 2000 Series AED in Rescue Mode while a USB cable is plugged into the unit DAC E2510EN BA WARNING SS 11 Technical Specifications 11 1 Defibtech DDU 2000 Series AED General 18 5 x 24x 5 8 cm Meets applicable requirements of e IEC 60601 1 e UL 60601 1 Design standards e CAN CSA C22 2 No 601 1 M90 e IEC 60601 1 2 e IEC 60601 2 4 e AAMI DF80 PN ll ith defibrillator f BF i li Device Classification Internally powered with defibrillato proo type patient applied parts per EN 60601 1 Patient safety All patient connections are electrically i
15. delivery voice and or visual prompts will inform the user 55 DAC E2510EN BA Defibtech DDU 2000 Series AED continued Environmental 0 50 C 32 122 ill 5 95 non condensing Maintenance F 700 to 1060 hPa 21 to 31 inHg Se 0 50 C 32 122 F ey ede 5 95 non condensing Transport 500 to 1060 hPa 15 to 31 inHg Altitud 150 to 4500 meters 500 to 15 000 feet per si MIL STD 810F 500 4 Procedure II Shock Drop Abuse Tolerance MILSTD 810F 516 5 Procedure IV 48 in 1 2 meters any edge corner or surface in standby mode MILSTD 810F 514 5 Category 20 Ground Vibration RTCA DO 160D Section 8 8 2 Cat R Zone 2 Curve G Helicopter RTCA DO 160D Section 8 Cat H Zone 2 Curves B amp R Jet Aircraft IEC60529 class IP55 Dust Protected Protected against water jets Battery pack installed ESD and EMI radiated and immunity Refer to Chapter 12 for details R amp TTE Directive 1999 5 EC Radio Frequency Emissions Applicable ETSI EN 300 220 2 V2 1 2 2007 06 Directive and Standards ERC RECOMMENDATION 70 03 ETSI EN 301 489 3 V1 4 1 2002 08 Ep Meets RTCA DO 160G Section 21 RF Radiated Emissions Aviation Category M Patient Analysis System Sealing Water Resistance The DDU 2000 Series Patient Analysis System ensures that the pad patient impedance is within the proper range and analyzes the patient s ECG rhythm to determine whether a shock is required On detection of a n
16. infants and children under 8 years or less than 55 pounds 25kgs is different than placement for adults and children 8 years or older or over 55 pounds 25kgs If you are unsure of a child s age or weight or do not have child infant pads do not delay treatment Place the pads on the patient s bare chest exactly as shown in the picture on the pad See diagrams below Sample Adult Pads Sample Child Infant Pads For adults and children 8 years or older or For infants and children under 8 years or less than over 55 pounds 25kgs use adult pads 55 pounds 25kgs use child infant pads Place one pad just below the patient s right collar bone Note Child infant pads can be identified by as shown in the picture Place the second pad over the ribs on the patient s left side below the left breast Use picture on pad to determine individual pad placement their blue connector and pads package Place one pad in the center of the chest and one pad on the center of the back as shown Use picture on pad to determine individual pad placement 21 DAC E2510EN BA 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 If there is a problem with the pad connection socket connection patient motion or oth
17. is selected use the TOP and BOTTOM softkey buttons to cycle through the different volume settings When the desired volume selection is chosen press the CENTER softkey button to set that volume level The AED will now use that volume setting for all audio except the volume of the Active Status Indicator beep The user may use the TOP or BOTTOM softkey buttons to navigate to other choices in the menu Note The factory default setting of the volume level is high 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 gt AED options gt Audio recording What it does The Audio recording option allows the user to enable disable recording of event audio data Once the Audio recording option item is selected use the TOP and BOTTOM softkey buttons to select either enabled or disabled settings When the desired selection is chosen press the CENTER softkey button to set the feature The AED will now use that audio recording setting The user may use the TOP or BOTTOM softkey buttons to navigate to other choices in the menu Note The factory default setting of the audio recording is disabled To manually configure rescue options such as Rescue protocol and CPR breathing select the Rescue options from the
18. most likely cause is that the battery pack needs to be replaced Refer to the Installing And Removing The Battery Pack section in Chapter 3 of this manual Once the battery pack has been replaced with a fresh battery pack the ASI should once again flash green If it still does not flash green after inserting a new battery pack the DDU 2000 Series AED is non operational and may need servicing Call Defibtech for service Refer to the Contacts section in Chapter 14 of this manual If the ASI is flashing red turn the DDU 2000 Series 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 Flashing Green The DDU 2000 Series AED is OFF and ready for use Solid Green The DDU 2000 Series AED is ON and ready for use Flashing or Solid Red The DDU 2000 Series AED needs immediate service Refer to the Troubleshooting section in this chapter or call Defibtech for service Active Status No Flashing Light The DDU 2000 Series AED needs immediate service Refer to the Indicator Troubleshooting section in this chapter or call Defibtech for service ASI 32 DAC E2510EN BA 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 t
19. needs servicing Replace battery pack or call for service Unit needs servicing Unit needs servicing Call for service Record code number and call for service Battery test failed service code xxxx Battery pack needs servicing Record code number and call for service Service required Unit needs servicing Call for service Replace battery now prompt Battery pack capacity is critically low Unit may not deliver a shock replace battery pack immediately Battery low prompt Battery pack capacity is getting low Replace battery pack as soon as possible Display screen does not work Battery pack depleted Replace battery pack Battery pack not inserted properly Make sure battery pack is oriented correctly and fully inserted Unit needs servicing Call for service Plug in pads connector prompt Pads connector not plugged in Plug in pads connector Pads connector broken Replace pads Unit s connector broken Call for service 38 DAC E2510EN BA Troubleshooting continued Apply pads to patient s bare chest as shown prompt 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 Poor pad contact to patient or Press pads firmly prompt Dry pads Partial pad
20. softkey buttons scroll and highlight the selection Go to main menu Press the CENTER softkey button The unit will exit the Help Topics menu screen and return to the AED Main Menu 48 DAC E2510EN BA 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 These defibrillation pads serve two functions e Allow the unit to read the patient s electrocardiograph ECG rhythm e Deliver defibrillation energy to the patient if needed The Defibtech self adhesive defibrillation pad assembly comes in a leads out sealed package that allows the device to be stored with the pads connected to the AED When the DDU 2000 Series AED is used the operator needs only to turn the device on remove the pad package tear open the package remove the pads from the blue liner apply the pads to the patient and administer care The AED has a storage area in the back of the unit that allows for storage of a single sealed adult pads package 9 2 Battery Packs The DDU 2000 Series AED uses a lithium battery pack to provide the AED with a long shelf and standby life The bat
21. the ECG analysis 26 DAC E2510EN BA CPR Coaching Help Prompts Purpose This guides the user to prepare the patient for rescue breaths and to give breaths Purpose This instructs the user to give rescue breaths Each time the instruction is given the user should give the patient a rescue breath 4 8 Operational Environment The Defibtech AED is designed to operate in a wide range of environmental conditions To ensure the reliability and safety of the AED in a given environment refer to the Environmental section in Chapter 11 of this manual for a detailed list of approved environmental conditions 27 DAC E2510EN BA 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 operatorinitiated 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 The DDU 2400 Manual Mode Charge feature is intended for use only by authorized operators who have been specifically trained in cardiac rhythm recognition and in WARNING manual defibrillation therapy 5 1 Entering Manual Mode When the Mode Select Icon is present on the screen the user may press the corresponding softkey button to bring up the Mode of Operation screen w AED
22. user during a rescue Mode Select Softkey Icon DDU 2400 2450 only When this icon is present on the screen during a rescue the user may press the corresponding softkey button to bring up the Mode of Operation selection screen 4 2 Preparation Checking The DDU 2000 Series AED Status Visually check the Active Status Indicator ASI The ASI should flash green The ASI flashes green to indicate ready for use status The ASI flashes red solid red or is not lit at all to indicate that service is required The ASI is powered by the battery pack If the battery pack has been completely discharged or is not installed in the unit the active status indication will not be available In this case immediately replace the battery pack or reinsert it into the unit to restore active status indication Flashing Green The DDU 2000 Series AED is OFF and ready for use Solid Green The DDU 2000 Series AED is ON and ready for use Flashing or Solid Red The DDU 2000 Series AED needs immediate service Refer to the Troubleshooting section in Chapter 7 of this manual or call Defibtech for service Active Status No Flashing Light The DDU 2000 Series AED needs immediate service Refer to the Indicator Troubleshooting section in Chapter 7 of this manual or call Defibtech for service ASI Turning On The DDU 2000 Series AED Press the green ON OFF button to turn the DDU 2000 Series AED on The unit will emit a beep and the disp
23. 93 5 879 374 6 016 059 6 047212 6 075 369 6 438 415 6 441 582 C T VRheinland 0197 us 65 DAC E2510EN BA
24. AED Main Menu screen Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to Rescue options AED Main Menu gt 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 e CPR breathing e Rescue protocol Settings e Default view e Manual Mode enable 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 Rescue options menu screen and return to the 46 AED Main Menu DAC E2510EN BA 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 gt Rescue options gt 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 When the desired selection is chosen press the CENTER softkey button to set the feature The AED will now use that coaching setting Note The factory default setting of CPR breathing is set to disabled Rescue Protocol The AED supports two rescue protocols at one time The Rescue protocol option allows the user to select a rescue protocol Rescue protocol o
25. Acu a short period of time the display Expires 06 2017 a AED SIN 099999999 screen and the unit will turn off Battery S N 099999999 Software version V2 1 AED Status screen 3 6 Completing The Installation Once you have completed the previous steps to set up your DDU 2000 Series AED follow this procedure 1 Turn the unit on by pressing the ON OFF button 2 Listen for the Call for Help voice prompt 3 Turn the unit off by pressing and holding the ON OFF button 4 Listen for the Powering Off voice prompt 5 Check Active Status Indicator ASI to verify that it is flashing green Refer to the Se f Tests section in Chapter 7 of this manual for instructions on how to run a manually initiated self test 3 7 Storing The DDU 2000 Series AED Store the DDU 2000 Series AED with defibrillation pads attached in environmental conditions within range of the specifications Refer to the Environmental section in Chapter 11 of this manual The unit should also be stored so that the Active Status Indicator ASI can be readily seen The Active Status Indicator ASI should periodically flash with a green light If it flashes with a red light or does not flash at all the DDU 2000 Series AED needs servicing Refer to the Checking The DDU 2000 Series AED Status section in this chapter for more information Defibtech recommends storing your AED in an easily accessible location 16 DAC E2510EN BA
26. Begin CPR Now Purpose This indicates that the user should begin performing CPR immediately The unit will not monitor the patient s ECG rhythm during this CPR period Give Compressions Give xx Compressions Purpose This indicates that the user should begin CPR compressions immediately The unit will emit a beep at the rate that compressions should be given Ei z Ei Continue 5 Continue xx Seconds Continue for 1 minute xx seconds Purpose This indicates that the user should continue performing CPR This phrase is spoken to let the user know that the unit is still operating normally The unit will not be monitoring the patient s ECG rhythm during this mandatory two minute CPR period AHA ERC 2010 Protocol Ending in 5 4 3 2 1 Ending in xx Seconds Purpose This indicates that the user should prepare to finish performing CPR This phrase is spoken during the last several seconds of the CPR period to let the operator know that the unit is still operating normally and that the CPR period is ending Stop CPR Stop CPR Stop Now Stop Now Purpose This indicates that the CPR period has ended and the user should stop CPR The unit will enter Analyze Mode Do not touch the patient Do Not Touch Patient Analyzing heart rhythm Analyzing Rhythm Purpose This indicates the unit has entered Analyze Mode and is performing an ECG analysis The user should not touch the patient during
27. D was turned on and connected to the patient until the unit is turned off e Provides maintenance personnel with additional parameter information to assist in troubleshooting a device suspected of malfunctioning Defibview is a stand alone software application Defibview cannot be used while the AED is in operation and its function is solely to support post event review A Not intended for clinical use Information presented by CAUTION Defibview should not be used for making clinical decisions 10 2 Defibtech Data Cards DDC Cards If a DDC card is installed in the unit every time the DDU 2000 Series AED is turned on the following information is recorded on a new file on the card e The time the AED was turned on e Other data such as ECG data time data audio data audio enabled cards only event milestones such as motion detection shock advice shock delivery information This information can be reviewed using the Defibview application Using non Defibtech Data Cards DDC cards may damage the unit CAUTION and will void the warranty 10 3 Downloading The Internal Data Log Regardless of whether a DDC card is installed in the unit select information is recorded internally within the DDU 2000 Series AED The information recorded is limited to e The time the AED was turned on e Other data such as event milestones motion detection shock advice shock delivery information etc e Important ECG information Note Audio
28. Defibtech DDU 2000 Series Automated External Defibrillator e DDU 2300 e DDU 2400 e DDU 2450 User Manual AHA ERC 2010 PRESS ON BUTTON APPLY PADS FOLLOW AED INSTRUCTIONS IF INSTRUCTED PRESS SHOCK BUTTON 2 DAC E2510EN BA 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 Limited Warranty The Limited Warranty shipped with Defibtech AED products serves as the sole and exclusive warranty provided by Defibtech LLC with respect to the products contained herein Copyright Copyright 2013 Defibtech LLC All rights reserved Copyright questions should be directed to Defibtech For contact information refer to Chapter 14 of this manual 3 DAC E2510EN BA Contents 1 Introduction To The DDU 2000 Series AED ek 6 ETE e EE 6 1 2 Th Defibtech DDU 2000 Series AED 8 E Meter le 10 EE e ae Elle tel EE 10 1 5 Operator Training Heourements cee ennai e ae aiiai 10 Dangers Warnings And Cautions c0cececeenenceeeeeneeeneeenenceeeeeneeeeeeenenenees 11 2 1 A Dangers Eeer 11 2 2 A Warnings Genee apa pid E baba acca A A tat Sewedvons 11 2 3 cautions SAAR ENEE Ate gaa RES ae naa ae aie ae
29. G Monitor MOG ince egchumgusgetekregekueguneeh EEE E EL 30 6 2 Applying The ECG Monitoring Electrodes cee eeeceeeeeeeeeeeeeeentnseeeeenaes 30 6 3 Monitoring Ihe Patient EE 31 Click any of the section headings above to be automatically re directed to that page See page references noted in green throughout this book for other interactive links 4 DAC E2510EN BA 10 11 12 13 14 Maintenance And Troublesboottng enee ENNEN ENEE EN ENEE ENEE En 32 7A Routine Unt Maitena Esnie E N E E dee Se 32 TA SEO ane te re re rere tre 36 K SSEN 36 TA Storage EE 36 75 Operators nl 37 76 MMOUDISSHOOUMG sietne eie e iaei ee eia ieai aaa e aaen 38 Det EE EE EE 39 Maintenance Node ue 40 GN Net A0 8 2 Navigation in Maintenance Model 40 8 3 Entering Maintenance Mode ege exceed eeeres vie dh onseed eersgude donee EEN 41 8 4 AED Malin Menu Schel renperrs iiyn arap sind ei a apia aiet 41 Bs AES EENEG 41 8 6 AED Maintenance SCreem sisscidcciviadsiase EENEG parar aei TEOR AEE EEO E Taa Ne 42 Bf AED Ree EE 44 GH Rescue Options Ebene EES gege 46 8 9 Help Topics E 48 DDU 2000 Series AED Accessories ee EN ENNEN NEE REENEN ENNEN EE ENEE ENN 49 g1 Tt elle ie 49 EE E EE 49 KC 49 GE USB EI EE 50 9 5 ECG Monitoring Adapter ccccecccccc cee cee cee eeeeeeeeeeeeeeeeecaeeeeeeeeeeeeesseeeeecteseeeeessneeeeeiaes 50 Event VA E 51 191 ebe gece Deiere eet de Zeie Seege Ee EN 10 2 Detibtech Data Cards DDC Cards ssicdstesuns
30. G waveform sensitivity and magnification settings are fixed and are not user adjustable 53 DAC E2510EN BA 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 max Vi 4 B t V min MI The waveform is adjusted to compensate for measured patient impedance Nominal phase times and energy delivered are shown in the tables below Phase Times DDP 2001 Adult and DDP 2003 Non attenuating Pediatric Defibrillation Pads Energy AED Mode DDP 2001 Adult Defibrillation Pads Nominal 25 50 75 100 125 150 175 150 J 153 151 152 151 153 146 142 Energy AED Mode DDP 2003 Non attenuating Pediatric Defibrillation Pads Nominal 54 DAC E2510EN BA Defibtech DDU 2000 Series AED continued Energy Manual Mode DDP 2001 Adult and DDP 2003 Non attenuating Pediatric Defibrillation Pads Nominal DDP 2003 pediatric defibrillation pads Selected Energy range is limited from 25 to 100 J Phase Time and Energy DDP 2002 Attenuating Pediatric Defibrillation Pads Applies to both AED and Manual Modes Note f impedance is out of range for proper analysis and shock
31. K button to be pressed the unit detects a rhythm change to a non shockable rhythm the unit will cancel the shock Also if the SHOCK button is not pressed within 30 seconds of the initial press flashing SHOCK button prompt the unit will automatically cancel the shock 25 DAC E2510EN BA Shock Related Prompts continued 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 No Shock Required Prompts No shock advised No Shock Advised It is safe to touch the patient OK to Touch Patient Purpose The DDU 2000 Series AED has determined that a shock is not required The unit will not charge and the SHOCK button will not be enabled The user will be prompted to begin CPR CPR Prompts Note CPR breathing coaching prompts can be set through the Rescue options menu option listed on the AED Main Menu screen The factory default setting provides prompts for chest compressions only no breathing Breathing prompts can be included either by changing the menu option refer to the CPR Breathing section in Chapter 8 of this manual or by pressing a softkey button during rescue Refer to Rescue Breathing Options Softkey Icon section of this chapter Begin CPR now
32. MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy 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 2000 Series is used exceeds the applicable RF compliance level above the DDU 2000 Series should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the DDU 2000 Series AED Separation Distances DDU 2000 Series AEDs are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of a DDU 2000 Series AED can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the DDU 2000 Series AED as recommended below according to the maximum output of the communications equipment Recommended separation distances between portable and mobile RF communications equipment and DDU 2000 Series AEDs eee Separation distance according to frequency of transmitter m Rated maximum 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter
33. Ventricular Tachycardia and Asystole Patient Analysis System Performance Meets the AAMI DF80 requirement and AHA recommendation of Sensitivity gt 90 Meets the AAMI DF80 requirement and AHA recommendation of Sensitivity gt 75 Meets the AAMI DF80 requirement of Specificity gt 95 and the AHA recommendation of Specificity gt 99 Meets the AAMI DF80 requirement and the AHA recommendation of Specificity gt 95 Meets the AAMI DF80 requirement and the AHA recommendation of Specificity gt 95 Shockable Rhythm Ventricular Fibrillation Shockable Rhythm Ventricular Tachycardia Non Shockable Rhythm Normal Sinus Rhythm Non Shockable Rhythm Asystole Non Shockable Rhythm All other non shockable rhythms 1 From Defibtech ECG Rhythm Databases 2 Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety American Heart Association AHA Task Force on Automatic External Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 95 1677 1682 3 Schneider T Martens PR Paschen H et al Multicenter randomized controlled trial of 150 J biphasic shocks compared with 200 to 360 J monophasic shocks in the resuscitation of out of hospital cardiac arrest victims Circulation 2000 102 1780 1787 Note Additional informati
34. able 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 Defibtech Data Cards DDC cards The optional DDC card plugs into a slot in the AED and enables the AED to record event documentation and optionally audio data onto the card Audio recording is selectable through configuration settings Event documentation stored internally can be downloaded onto a DDC card for review A USB port is provided to perform maintenance and data recovery The USB interface allows connection to a personal computer Defibtech PC maintenance software helps support event downloading and unit maintenance operations 7 DAC E2510EN BA 1 2 The Defibtech DDU 2000 Series AED A Speaker The speaker projects the voice prompts when the DDU 2000 Series AED is on The speaker also emits a beep when the unit is off and has detected a condition that requires attention from the user or needs servicing 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 C Display 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 coac
35. ade follow the displayed and spoken instructions Transfer Data To Card E Transfer data to card will initiate a data transfer from the DDU 2000 Series AED to a Defibtech Data Card DDC card inserted in the device Internal event data and device history is written to the DDC card Before you begin Be sure the unit is in Maintenance Mode Be sure a DDC Card is installed in the device Refer to the Installing The Defibtech Data Card DDC card section in Chapter 3 of this manual To enter Navigate to Transfer data to card AED Main Menu gt AED maintenance gt Transfer data to card What it does The unit begins transferring rescue data to the card The unit says Transferring data to data card The unit displays Transferring Data The unit will finish transferring data to the data card and will speak and display data transfer complete Do not turn off the unit or remove the battery WARNING pack or data card until the operation is complete Note f 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 transferring the data to the data card it will automatically return to the AED Maintenance menu screen Format Data Card D Format data card is a maintenance tool used to repair corrupted cards Itis unnecessary to perform this s
36. aging For Recycling Packaging should be recycled in accordance with local and national requirements 11 8 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 At the end of its lifetime this device can only be disposed of in compliance with the provisions of the above mentioned European directive and following possible revisions as well as with the corresponding nation al regulation Severe penalties are possible for unauthorized disposal Electrical and Electronic Equipment EEE may contain polluting components and hazardous substances the accumulation of which could pose serious risk for the environment and human health It is for this reason that local administrations provide regulations which encourage reuse and recycling and prohibit the disposal of WEEE as unsorted municipal waste and require the collection of such WEEE separately at specifically authorized treatment facilities Manufacturer and authorized distributors are required to supply information about a safe treatment and disposition of the specific device You may also return this equipment to your distributor when purchasing a new one As for reuse and recycling notwithstandi
37. alcohol 70 percent solution Chlorine bleach 30 mi liter water e Ensure that the connector socket is completely dry before reinstalling the pads cable After cleaning allow the unit to completely dry Before returning it to service always check the AED operational status Refer to Checking The AED Status Using The AED Status Screen earlier in this chapter 7 4 Storage The DDU 2000 Series AED should be placed in a readily accessible location in an orientation where the Active Status Indicator ASI next to the ON OFF button can be easily seen In general the unit should be stored in clean dry and moderate temperature conditions Make sure that the environmental conditions of the storage location are within the ranges detailed in the Environmental section in Chapter 11 of this manual 36 DAC E2510EN BA 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 Defibtech DDU 2000 Series Operator s Checklist Defibtech DDU 2000 Series AED Serial Number Defibtech DDU 2000 Series AED Location Check unit and accessories for damage dirt and contamination Clean or replace as necessary Check that spare battery pack and pads are available Check that battery pack and pads a
38. ata card USB port access door by slightly pushing and then sliding the door down to release the latch The door will spring open Insert the DDC card into the thin slot in the side of the AED centered above the USB port opening notched end first label side up until it clicks into place The card should 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 To remove the DDC card press the card as far as it will go and then release Upon release the DDC card will be partially ejected and can be removed by pulling the DDC card the rest of the way out Close the data card USB port access door by closing and then pushing the door up until the door latch engages Using non Defibtech Data Cards DDC cards may damage the unit CAUTION and will void the warranty 14 DAC E2510EN BA 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 The battery pack will onl
39. btech or its authorized distributors Substitution of non Defibtech approved accessories may cause the device to perform improperly e Do not open sealed pads package until pads are to be used e Do not touch the patient during defibrillation Defibrillation current can cause operator or bystander injury e Do not allow pads to touch metal objects or equipment in contact with the patient Do not touch equipment connected to the patient during defibrillation Disconnect other electrical equipment from the patient before defibrillation e Do not shock with defibrillation pads touching each other Do not shock with gel surface exposed e Do not allow defibrillation pads to touch each other or to touch other ECG electrodes lead wires dressings transdermal patches etc Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart e The defibrillation pads are intended for one time use only and must be discarded after use Reuse can lead to potential cross infection improper performance of the device inadequate delivery of therapy and or injury to the patient or operator e 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 e Disconnect all non defibrillator proof equipment from the patient before defibrillation to prevent elec
40. ce pads on the patient following instructions on the pads package If the prompts continue try replacing the pads with a new set Poor pad contact to patient Poor Pad Contact Press pads firmly Press Pads Firmly Purpose The pads are not making proper contact with the patient and the impedance is out of range for proper ECG analysis and shock delivery Check that the pads are properly placed and fully adhering to the patient and that there are no air bubbles between the pads and the patient If the pads are not sticking due to moisture dry the patient If the pads are not sticking due to excessive hair shave or clip excessive chest hair If the prompts continue try replacing the pads with a new set Check pads Check Pads Purpose The pads are making improper contact with the patient or touching each other and the impedance is out of range for proper ECG analysis and shock delivery Check that the pads are not touching each other and that the patient is dry If the prompts continue try replacing the pads with a new set Pausing for CPR Pausing for CPR Purpose H too long a period of time has passed the user should stop attempting to resolve problems with the pads and assess the condition of the patient The user will be prompted to begin CPR Replace pads Replace Pads Purpose The pads are making improper contact with the patient or touching each other and the impedance is out of range for proper ECG analysis
41. d 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 Concise and easily understandable voice messages and text and video prompts guide the operator through the use of the unit The following sections describe in detail how to use the DDU 2000 Series AED The basic steps for use are e Turn the DDU 2000 Series AED ON by pressing the ON OFF button e Plug in pads connector into Pad Connector Socket on AED if not yet plugged in e Place defibrillation pads on patient follow instructions on pads package e Follow voice and display prompts e Press SHOCK button if instructed by the AED e Perform CPR when instructed 4 1 Overview Pads Connector Socket Socket for pads connector Active Status Indicator ASI Indicates the current status of the AED ON OFF Button Turns AED on and off Softkey Buttons Top Center Bottom Buttons used to navigate menus or select options Display Screen Displays video or ECG text prompts and information Speaker Creates audio output from device SHOCK Button Enabled disabled by software to allow the user to discharge a shock to the patien
42. dapter optional DDU 2400 2450 only K Unit Serial Number L Battery Pack Opening M Battery Pack Eject Release Latch N Pad Storage Area O Pads Connector BACK OF AED S Battery Pack P Q Defibrillation Pads Defibrillation Expiration Date Pads ve a on back of package T Battery Pack Expiration Date R Battery Pack Serial Number BATTERY PACK 9 DEFIBRILLATION PADS PACKAGE DAC E2510EN BA 1 3 Indications The DDU 2000 Series Semi Automatic External Defibrillator AED is indicated for use on victims of sudden cardiac arrest SCA who are e Unconscious and unresponsive e 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 4 Contraindications The AED should not be used if the patient shows any of the following signs e Conscious and or responsive e Breathing e Has a detectable pulse 1 5 Operator Training Requirements In order to safely and effectively operate the AED a person shall have met the following requirements e AED and or defibrillation training as required by local state provincial or national regulations e Any additional training as required by the authorizing physician e Thorough knowledge and understanding of the material presented in this User Manual Manual Mode DDU 2400 is intended for use only by qualified medical personnel tra
43. e for rapid deployment during an emergency Pads Connector This connector attaches the patient pads to the unit at the Pads Connector Socket item E Defibrillation Pads The defibrillation pads are pads that are placed on the patient The pads may be stored in the pad storage area item N on the back of the unit Defibrillation Pads Expiration Date back side The defibrillation pads expiration date is located on the back side of the pads package Do not use the pads after the printed date has passed Battery Pack Serial Number The battery packe serial number is located on the label on the battery pack Battery Pack The battery pack provides a replaceable main power source for the DDU 2000 Series AED Battery Pack Expiration Date The battery pack expiration date is printed on the label on the battery pack Do not use the battery pack after the printed date has passed ECG Monitoring Adapter This optional adapter for the DDU 2400 and the DDU 2450 provides a non diagnostic ECG display of the patient s heart rhythm for attended patient monitoring 8 DAC E2510EN BA E Pads Connector Socket D ON OFF Button F Active Status Indicator ASI C Display Screen G Softkey Buttons Top Center Bottom B SHOCK Button A Speaker H USB Port l Defibtech Data Card DDC Card optional J USB and Defibtech Data Card FRONT OF AED DDC Card Access Door U ECG Monitoring A
44. e unit is in Maintenance Mode Be sure a DDC Card with a card application is installed in the device Refer to the Installing The Defibtech Data Card DDC card section in Chapter 3 of this manual To enter Navigate to Run application from card AED Main Menu gt AED maintenance gt Run application from card Do not turn off the unit or remove the battery WARNING pack or data card until the operation is complete Note f 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 To manually configure AED options such as time date volume and audio recording select the AED options from the AED Main Menu screen Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to AED options AED Main Menu gt AED options 44 DAC E2510EN BA 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 e System time e System date e Volume level e 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
45. ectly to Rescue Mode The other menu options will perform different functions and are described in detail below The AED Status screen displays unit specific data such as current status battery pack charge state battery pack expiration date defibrillation pads expiration date unit serial number battery pack serial number and software version number Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to AED status AED Main Menu gt AED status Note When the unit is turned off the AED Status screen can also be accessed by pressing the center softkey button What it does The unit will display the AED Status screen This is an informational screen only no action is taken by the AED To exit To exit the AED Status screen press and release the BOTTOM softkey button The unit will exit the AED Status screen and return to the AED Main Menu screen 41 DAC E2510EN BA 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 gt AED maintenance What it does The unit will display the AED Maintenance menu screen This screen will allow the user to navigate further to perform various maintenance tasks e Perform AED test e Upgrade AED e Transfer data to card e Format data card e Run application from card T
46. eed aa aS 12 Setting Up The DDU 2000 Series AED ek REENEN ENEE ENEE EEN 13 Ge e 13 3 2 Connecting Wett el Ed ele Me 13 3 3 Installing The Defibtech Data Card DDC Card Optional 14 3 4 Installing And Removing The Battery Pack 15 3 5 Checking The DDU 2000 Series AED Status esscr a aa 15 3 6 Complen The INstallatiOnse isaccessued ature treteeie Seege Sheet aes 16 3 7 storing ihe DDU 2000 Series AED isi ievccseraisioans iaviagnaabnekonad eee ea aA 16 Using The DDU 2000 Series In AED Mode 22202c2cecceeeeeeeeeeeeeeeeeeeceeeeeeeenens 17 Al e e 17 4 2 Dreparanon ee ee eee eee ee 19 4 3 Hean RAY TAINAN ELV SIS sccseeceencendueaetetes seandde day reg ENE eE Zeg Zeg d e gege 22 AA Delivering TINE SHOCK oe eecscavarsbedavs vg ege tober agefuer 22 Ny PIR le CHOC EE 22 E lee 23 4 7 AED Mode Voice And Text Prompte risie sisines atei aiaia i S 23 4 8 Operationall GA el EE 27 Manual Mode DDU 2400 op ee EN ENEE REENEN EEN 28 5 1 Entering Manual Mes icosssiesecsnavded enana conse edusdenetde decease HEEN 28 52 Exiting Manual MOGE ecco scccciexssedeviaesavciyarveghvanctwctgapenadavevneteatvonsapteuean ctueteaanaptdiateecheds 28 5 3 Selecting ME te VE 29 5A Initiating GATOS E 29 55 Delivering TINE SNOOK sre cess cans vahaswcecuss sven sabenzuecasssihbsad snyuends sulebpndenenacaaatebawehnenecabasteandanels 29 ECG Monitor Mode DDU 2400 2450 only secesscteceeceeeceeeeeeeeseeeeeeeeeeaseeeeeeeeeseeeeoes 30 6 1 Entering EC
47. elated 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 When a softkey icon for example an arrow appears on the display screen directly to the left of a softkey button the softkey button is functional for that screen If a softkey icon is not displayed on the screen then the corresponding softkey button has no functionality for that screen Note While the unit is in Maintenance Mode it cannot perform a rescue Maintenance Mode allows the user to go directly to AED Mode by selecting the Rescue now option The Rescue now option appears at the top of every screen menu when the unit is in Maintenance Mode The user can also exit Maintenance Mode at any time and go to AED Mode by pressing the ON OFF button to turn the unit off and then immediately pressing the ON OFF button again to turn the unit back on The Display Screen During Maintenance Mode Options AED maintenance AED options Rescue options Help topics Turn AED off Softkey Buttons Title The name of the menu appears in a banner across the top of the screen Softkey Buttons Softkey buttons are used to scroll through menus and to select menu options Sof
48. enance Mode Refer to the CPR Breathing section in Chapter 8 of this manual Rescue Breathing Options Softkey Icon During a rescue when this icon is present on the screen the user may press the corresponding softkey button to select CPR coaching with compressions only no breathing or CPR coaching with compressions and breathing Note Refer to the CPR Breathing section in Chapter 8 of this manual for instructions on how to change the factory default setting When this Information Softkey Icon is present on the screen the user may press the corresponding softkey button for additional information with video 22 instruction To exit press the softkey button again DAC E2510EN BA 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 Refer to the Se f Tests section in Chapter 7 of this manual for instructions on how to run a manually initiated self test 3 Turn off the unit by pressing the ON OFF button 4 Check to make sure that the Active Status Indicator ASI is flashing green 4 7 AED Mode Voice And Text Prompt
49. er interference the AED will guide the operator with both audible and displayed instructions Text prompts are identical to or are an abbreviated form of the audio prompts Video prompts reinforce the audio and text prompts and aid in high ambient noise environments 4 3 Heart Rhythm Analysis Once the DDU 2000 Series AED has determined that the pads are making a good connection to the patient the AED will start the ECG rhythm analysis The unit analyzes the ECG signal and determines whether a shockable or non shockable rhythm is present While analyzing the AED will continue to monitor signal and pad conditions and will reassess analysis and prompt the user if additional user action is needed 4 4 Delivering The Shock If the DDU 2000 Series AED ECG analysis algorithm has determined that a shock is required the unit will automatically charge in preparation for shock delivery While the AED charges the unit may emit a charging tone and will continue to analyze the patient s heart rhythm If the unit detects that the heart rhythm has changed to one that does not require a shock the unit will prompt the user to begin CPR While analyzing the AED will continue to monitor signal and pad conditions If the unit has determined that a shock is required and has completed charging the SHOCK button will flash and the user will be instructed to press the flashing SHOCK button The user should follow the AED instructions and press the SHOCK button
50. ergency 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 While connected to the ECG Monitoring Adapter the DDU 2400 2450 AED s shock capability is disabled but it continues to evaluate the patient s ECG There are no known contraindications to use of the ECG Monitoring Adapter Note The AED does not have to be turned off before changing from defibrillation pads to the ECG Monitoring Adapter or vice versa To deliver a shock to the patient disconnect the ECG Monitoring Adapter and attach the defibrillation pads 6 1 Entering ECG Monitor Mode Remove the defibrillation pads and plug in the optional ECG Monitoring Adapter The AED will automatically switch to ECG Monitor Mode with ECG view and onscreen text prompts will provide instruction NOTE Voice prompts are disabled while in ECG Monitor Mode f the pads are not applied the display will show a dashed ECG and prompt the user to apply the pads When the pads are applied the display shows the patient s ECG and heart rate Note The ECG Monitoring Adapter uses the same connector socket in the AED used by the defibrillation pads 6 2 Applying The ECG Monitoring Electrodes Apply ECG monitoring electrodes to the patient s chest as sh
51. est if necessary the defibrillation pads will stick better on dry skin If necessary shave excessive chest hair which can prevent effective patient electrode contact To ensure that defibrillation pads fully contact the patient s skin check that no jewelry or other objects are directly underneath where the pads will be placed Connecting The Defibrillation Pads To The DDU 2000 Series AED Connect pads to unit if not already connected Follow AED voice and display instructions The DDU 2000 Series AED is designed to be stored with the defibrillation pads connector attached to the unit while the pads themselves remain sealed in their package This reduces the time needed to setup and start treatment in an emergency The Defibtech AED should be stored with the pads connector attached to the unit However if pads were damaged or not properly connected you may need to substitute a new set of pads during an emergency The pads connector socket is on the top left corner of the AED To detach a set of pads from the unit pull firmly on the pad connector Do not reuse used pads Insert the connector for the new pads as shown above The connector will only fit in one way if the connector does not fit rotate the connector before trying again Insert connector firmly until it is completely seated in the unit When this Information Softkey Icon is present on the screen the user may press the corresponding softkey button for additional informati
52. eticcnmisnsnetecwmien tenants 51 10 3 Downloading The Internal Daalog 51 Technical Specifications kee 52 11 1 Defibtech DDU 2000 Series AED 52 WZ Battery PACKS creiere i E EE rane reeled Fete eee 58 11 3 Self Adhesive Defibrillation Pad 58 11 4 ECG Monitoring Adapter Cable Optional cee eeeseeeeeeeeeteeeeteneeeens 58 T15 Event DOCUIMONTAUON a gegen te Eege Deen dnote Ee Eege 59 11 6 Detibtech Event Meet 27 Age ee AEN eben Eeer WR eon Wes 59 11 7 Recycling I AFORMATION sccccciccssvizvossieres SSES 59 11 8 Notice To European Union Customers isrann irrena a a a 59 Electromagnetic Conftormity ENER REENEN cece eee EEN ENEE ENEE ENEE GO 12 1 Guidance And Manufacturer s Declaration c cccccccceeeceeeteeceeeeeeeeeeeteeeecneesetteenteeeenees 60 Glossary Of SyMbDols 2 21ccccceeee eee ee eee eee eee ee ee eee ee EN 63 COMEAGCES won E E eee eae bende ewes estes eee ek het i eet eel 65 Click any of the section headings above to be automatically re directed to that page See page references noted in green throughout this book for other interactive links 5 DAC E2510EN BA 1 Introduction To The DDU 2000 Series AED 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 inf
53. etting is set to Video 8 et Manual Mode Enable DDU 2400 only The Manual Mode enable option allows the user to enable or disable the Manual override feature of the DDU 2400 only Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to Manual Mode enable AED Main Menu gt Rescue options gt Manual Mode enable What it does Enables or Disables the Manual Mode feature of the AED Use the TOP and BOTTOM softkey buttons to select the desired mode When the desired selection is chosen press the CENTER softkey button to set the feature The AED will now use that setting Note The factory default setting is set to Enabled This menu item is only available in the DDU 2400 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 gt Help topics What it does The Help topics provides a list of available help topics The Help topics are the following e Preparing the patient e Analyzing and shocking e Performing CPR e Replacing the battery e Replacing the pads e Checking the AED status e Replacing the data card Use the TOP and BOTTOM softkey buttons to scroll through the different Help topics items When the desired help selection is highlighted with a box press the CENTER softkey button to get more information To exit Using the TOP or BOTTOM
54. fibrillation pads Discard defibrillation pads after use in the event of suspected pad malfunction return pads to Defibtech for testing e Recycle or dispose of lithium battery packs in accordance with federal state and or local laws To avoid fire and explosion hazard do not burn or incinerate the battery pack Do not crush e Use and store the DDU 2000 Series AED only within the range of environmental conditions specified in the technical specifications e f possible disconnect the DDU 2000 Series AED from the patient prior to use of other defibrillators e Do not connect the DDU 2000 Series AED to a PC or other device using the USB port while the unit s electrodes are still connected to the patient e Using non Defibtech Data Cards DDC cards may damage the unit and will void the warranty e Although the DDU 2000 Series AED is designed for a wide variety of field use conditions rough handling beyond specifications may result in damage to the unit 12 DAC E2510EN BA 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 Replacement and o
55. follow the text prompts to address the condition requiring attention or refer to the 7 Troubleshooting section in Chapter 7 of this manual To exit Press any softkey button The self test status pop up window will clear and the display will return to the AED Maintenance menu screen Upgrade AED The Upgrade AED menu selection is a method of performing a unit upgrade and will activate the system upgrade procedure from a Defibtech Data Card DDC card containing an upgrade application Note Upgrades can also be performed directly from the AED Status Screen if an upgrade card is present when the AED Status Screen mode is launched Before you begin Be sure the unit is in Maintenance Mode 42 DAC E2510EN BA To enter Navigate to Upgrade AED AED Main Menu gt AED maintenance gt Upgrade AED What it does f an upgrade data card is present the unit will start performing the upgrade process Follow any prompts and instructions that the upgrade application provides Do not turn off the unit or remove the battery WARNING pack or data card until the operation is complete Note f the DDC 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 Press any softkey button to acknowledge the message and then install a Defibtech Data Card DDC card To exit When the unit finishes performing the AED upgr
56. he AED Status Screen The AED Status Screen 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 Rescue Mode AED status With the AED off press and release the CENTER softkey button to display the AED Status Screen The AED Status Screen will be displayed Battery status f E for a short period of time Expires 01 2017 Pads status Adult If the unit does not turn on check to make sure a good battery pack is Expires 06 2017 SS or AED SIN 999999999 installed Refer to the Troubleshooting section in this chapter Battery SIN 099999999 Se From the AED Status Screen you can enter Maintenance Mode by pressing the Software version V2 1 softkey button to the right of the Tool Icon Note f the unit requires service the AED Status Screen will present information about the problem to the user The user should follow the text prompts to address the condition requiring attention Card Application Softkey Icon If an application is present on an inserted Defibtech Data Card DDC card a card icon will also appear next to the center softkey button Pressing this button will load and run the application contained on the card Maintenance Related Prompts Power on test failed Power On Test Failed Service code xxxx Service Code xxxx Purpose This indicates that the DDU 2000 Series AED has failed the poweron se
57. he 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 After connecting the pads connector to the unit push the pads package rounded end first with the pictures on the package facing out into the pad holder compartment on the back of the AED When the pads package is fully inserted press the pad cable into the groove in the back of the unit to hold the cable in place and tuck any excess cable behind the pads package The pads are intended for one time use only and must be discarded after use or if the package has been opened WARNING or damaged 3 3 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 critical event information internally DDC cards may be reviewed with a separate Defibtech PC based software package Refer to the Defibview section in Chapter 10 of this manual Before installing the DDC card ensure the AED is turned OFF Locate the data card USB port access door on the right hand side of the unit Open the d
58. hing to assist rescuers with step by step instruction DDU 2400 2450 models can also show an ECG trace D ON OFF Button This button is used to turn the DDU 2000 Series AED on and off E Pads Connector Socket The pads connector item O is inserted into this socket F Active Status Indicator ASI The ASI indicates the current status of the AED This indicator flashes green to indicate the unit is ready for use and flashes red to indicate unit needs attention from the user or needs servicing G Softkey Buttons Three context sensitive softkey buttons are used to navigate menus or select actions H USB Port The USB port is provided to perform data recovery and maintenance Not to be used during rescue operation l Defibtech Data Card DDC card This optional plug in card provides enhanced storage capabilities to the AED J USB and Defibtech Data Card DDC card Access Door Behind the access door is the USB connector port and Defibtech Data Card DDC card slot K Unit Serial Number The unit s serial number can be found on the back of the AED above the battery pack opening Battery Pack Opening This opening is where the battery pack is inserted into the unit Battery Pack Eject Release Latch This release latch releases the battery pack from the DDU 2000 Series AED Pad Storage Area The pad storage area is found on the back of the AED allowing the pads to be stored in a pre connected stat
59. in Menu gt AED options gt System date What it does The System date option allows the user to set the date of internal AED clock Once the System date option is selected press the CENTER softkey button to enter set date mode The year selection will be highlighted green e Press the TOP or BOTTOM softkey buttons to adjust the year e Press the CENTER softkey button to accept the year setting The month selection will be highlighted green e Press the TOP or BOTTOM softkey buttons to adjust the month e Press the CENTER softkey button to accept the month setting The day selection will be highlighted green e Press the TOP or BOTTOM softkey buttons to adjust the day e Press the CENTER softkey button to accept the day setting 45 DAC E2510EN BA 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 E 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 To enter Navigate to Volume level AED Main Menu gt AED options gt Volume level What it does The Volume level option allows the user to set AED audio to high medium or low volume Once the Volume level option
60. ined in advanced life support skills and ECG recognition who want to deliver a shock independent of AED Mode ECG Monitor Mode DDU 2400 and DDU 2450 only is intended to be used by personnel trained in basic life and or advanced life support or other physician authorized emergency medical training Users should be trained in ECG recognition to allow for rhythm and heart rate monitoring using standard ECG monitoring electrodes 10 DAC E2510EN BA 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 A DANGERS Immediate hazards that will result in serious personal injury or death e Hazardous electrical output This equipment is for use only by qualified personnel e Potential for explosion The DDU 2000 Series AED is not suitable for use in an oxygen enriched atmosphere or in the presence of a flammable anesthetic mixture with air or nitrous oxide e The DDU 2000 Series AED has not been evaluated or approved for use in hazardous locations as defined in the National Electric Code standard In compliance with IEC classification the DDU 2000 Series AED is not to be used in the presence of flammable substance air mixtures 2 2 A WARNINGS Conditions
61. lay 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 the unit will emit a beep and power off Call For Help Call professional emergency services for help As soon as the AED is turned on the unit will prompt the user to Call for help This is a reminder 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 19 DAC E2510EN BA Selecting an Alternate Spoken Language 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 Pressing the Language Softkey Icon again will switch the spoken language back to the primary language The Language Softkey Icon is available only until the defibrillation pads are Follow Instructions connected to the patient Preparing The Patient Prepare the patient by removing any clothing from the patient s chest Wipe away moisture from the ch
62. lf test and is non operational and needs servicing The code number will indicate to service personnel the type of problem the unit is experiencing Battery test failed Battery Test Failed Service code NN Service Code xxxx Purpose This indicates that the DDU 2000 Series AED s battery pack is non operational and needs servicing The code number will indicate to the service personnel the type of problem that the unit is experiencing Service code xxx Service Code xxxx Purpose The DDU 2000 Series AED will report this message when it powers off indicating a service code that was previously detected Service required Service Required Purpose This indicates that the DDU 2000 Series AED has detected an internal error is non operational and needs servicing Battery low Battery Low Purpose This indicates that the battery pack capacity is low and that the battery pack should be replaced soon The AED will still be able to deliver at least six defibrillation shocks the first time this message is spoken Replace battery now Replace Battery Now Purpose This indicates that the battery pack is almost discharged and that the AED may not be able to deliver defibrillation shocks Replace the battery pack immediately Purpose This indicates that the unit did not detect connected pads during a self test Pads expired Pads Expired Purpose This indicates that defibrillation pads have ex
63. ll anew DDC card insert the DDC card into the thin slot in the side of the AED centered above the USB port opening notched end first label side up until it clicks into place The card should 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 Close the data card USB port access door by closing and then pushing up the door until the door latch engages Note A DDC card is not required for the DDU 2000 Series AED to operate Even if a DDC card is not installed the unit will still record basic essential information internally The AED will still operate properly even after a replace data card message 35 DAC E2510EN BA 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 poweron self tests are performed to test the basic operation of the unit The unit also performs daily weekly monthly and quarterly self tests automatically without any intervention from the operator to check the integrity of the unit s hardware and software The unit will also perform a battery insert self test when the battery pack i
64. ll turn on and display the AED Status Screen for a short period of time Battery status Expires 01 2017 Pads status Adult If the unit does not turn on check to make sure a good battery pack Expires 06 2017 is installed Refer to the Troubleshooting section in Chapter 7 AED SIN 099999999 Battery S N 099999999 9 of this manual Software version V2 1 S STEP 2 Press the BOTTOM softkey button to the right of the Tool Icon Note If the bottom softkey button is not pressed within a short period of time the unit will automatically turn off Result The unit will enter Maintenance Mode and display the AED Main Menu screen The AED Main Menu screen allows the user to view the status of the AED perform maintenance functions change AED options and access help topics All maintenance functions are accessed through the AED Main Menu screen The user may select from the following options using the softkey buttons Rescue now Puts device in Rescue Mode AED status AED status Displays current AED status information AED maintenance AED maintenance Displays AED Maintenance Menu screen AED options Rescue options AED options Displays AED Options Menu screen Rescue options Displays Rescue Options Menu screen Help topics Turn AED off Help topics Displays Help Topics screen 4 Turn AED off Turns unit off When the user selects Rescue now the unit will exit Maintenance Mode and proceed dir
65. mended e Delivers a shock once the device has determined a shock is required and the SHOCK button has been pressed e Provides instructions to perform CPR e Repeats the process if additional shocks are required e Allows user to select between Video display or ECG display DDU 2400 and DDU 2450 only In ECG Monitor Mode DDU 2400 and DDU 2450 only the AED allows display of the patient ECG using an optional 3 wire LEAD II ECG adapter cable ECG Monitor Mode provides a non diagnostic display of the heart rhythm of a responsive or breathing patient for attended patient monitoring While connected to the ECG adapter cable the AED disables its shock capability Manual Mode DDU 2400 only allows the user to override the automatic features of the AED Manual Mode provides for operator selected energy levels along with charge shock and disarm features In AED Mode the DDU 2000 Series AED will NOT shock a patient automatically it will only advise the operator The SHOCK button is enabled only when a shockable rhythm is detected and the device is charged and ready to shock Charging occurs automatically when the device detects a shockable rhythm The operator must press the SHOCK button to initiate defibrillation In Manual Mode the operator is responsible for making the shock no shock decision initiating charging and delivering the shock The DDU 2000 Series AED uses two self adhesive defibrillation pads also known as electrode pads
66. ng the limits imposed by the nature and the use of this device the manufacturer will do its best to develop recovery processes Please contact the local distributor for information 59 DAC E2510EN BA 12 Electromagnetic Conformity 12 1 Guidance And Manufacturer s Declaration The essential performance of the DDU 2400 2450 AED is successful delivery of defibrillation therapy and accurate differentiation between shockable and nonshockable rhythms DDU 2400 2450 AEDs are intended for use within the electromagnetic environment specified below The customer or the user of the DDU 2400 2450 AED should assure that it is used within the stated environmental specifications ELECTROMAGNETIC EMISSIONS RF emissions Group 1 The DDU 2000 Series AED uses RF energy only for its CISPR 11 Class B internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby CISPR 22 Class B electronic equipment al Part 15 Class B Harmonic emissions Harmonic emissions IEC 61000 3 2 61000 3 2 Not applicable Battery operated equipment Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Battery operated equipment ELECTROMAGNETIC IMMUNITY Electrostatic discharge ESD IEC 60601 4 2 8 kV contact 8 kV contact There are no special requirements 15 kV air 15 kV air with respect to electrostatic discharge 2 kV for power line Electrical fast transient burst su
67. ng this phase 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 Purpose The DDU 2000 Series AED is charging and the operator and others should stand clear of the patient Analysis will continue during this phase and analyzing prompts will continue to be displayed 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 Press flashing SHOCK button Press SHOCK Button Purpose The DDU 2000 Series AED has fully charged the heart rhythm analysis algorithm still indicates that a shock is recommended and the unit is ready to deliver a shock The operator should press the SHOCK button to deliver the shock The SHOCK button will flash during this phase and will cancel after 30 seconds Important The DDU 2000 Series AED will not automatically deliver a shock the user must press the SHOCK button Shock x delivered Shock x Delivered Purpose The DDU 2000 Series AED has delivered the shock The x indicates the number of shocks that have been delivered since the unit was turned on After each shock the AED will enter Post Shock CPR mode AHA ERC 2010 Protocol Shock cancelled Shock Cancelled Purpose The DDU 2000 Series AED has aborted shock mode If while waiting for the SHOC
68. nt Remove clothing from patient s chest Remove Clothing Purpose This instructs the user to remove all clothing from patient s chest Pads must be applied to the patient s bare chest Locate pads package in back of AED Locate Pads Purpose This helps the user locate the pads in the pad storage area which is located on the back of the unit Plug in pads connector Plug In Pads Purpose The DDU 2000 Series AED is unable to detect that the pads are plugged in Check that the connector is fully inserted into the unit If the pads are properly plugged in continue to follow audio and visual instructions Tear open pads package Open Pads Package Purpose This instructs the user to tear open the pads package on the dotted line on the top of the package Once the package is open the user will be able to remove the pads from inside the package 23 DAC E2510EN BA Pad Connection Pad Application Related Prompts continued 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 Apply pads to patient s bare chest as shown Apply Pads to Patient Purpose The DDU 2000 Series AED has determined that the pads are not placed on the patient or not properly applied Pla
69. o exit Use the TOP or BOTTOM softkey buttons to scroll to and highlight the selection Go to main menu Press the CENTER softkey button The unit will exit the AED Maintenance screen and return to the AED Main Menu screen Perform AED Test Perform AED test will initiate a system hardware and software self test Note Running manually initiated AED tests will consume approximately one shock s worth of battery life Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to Perform AED test AED Main Menu gt AED maintenance gt Perform AED test What it does When the user selects Perform AED test selection and presses the CENTER softkey button the unit will begin performing the self test procedure The unit says Performing AED test The unit displays Testing AED The unit will then prompt the user to Press flashing shock button Continue to follow the directions until the test is complete Once the AED test is complete the unit will verbally and visually report the status of the AED The information will be displayed in a pop up window The user must press any softkey button to confirm the test status and return to the AED Maintenance screen If self test passes The unit will speak and display AED OK If self test fails The unit will display an error screen with text prompts providing instructions to address the condition Note f self test fails the user should
70. oftkey button again Mode Select Softkey Icon DDU 2400 2450 only When this icon is present on the screen during a rescue the user may press the corresponding softkey button to bring up the Mode of Operation selection screen WAT ees Manual Mode gt O AED ECG Mode _ O Mode of Operation screen with corresponding softkeys DDU 2400 2450 only The user may then select AED Mode with video AED Mode with ECG or Manual Mode available only for DDU 2400 with Manual Mode enabled by pressing the corresponding softkey button If no selection is made within 8 seconds the AED will continue in the current mode The current mode is indicated with a green check mark next to it 18 DAC E2510EN BA Unit ECG Display Screen During AED Mode DDU 2400 2450 only Battery Indicator gt 00 00 35 Mode Select Text Prompts gt Analyzing lt 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 Shock Count The Shock Count displays the number of shocks delivered for current event Main Screen The Main Screen displays the patient s ECG if the pads are connected Text Prompts The Text Prompt Area displays text prompts to guide the
71. omatic self tests are designed to assess the DDU 2000 Series AED s readiness for use However no degree of testing can assure performance or detect abuse damage or a defect that occurred after the most recent test is completed e Use of damaged equipment or accessories may cause the device to perform improperly and or result in injury to the patient or operator e The DDU 2400 Manual Mode Charge feature can deliver dangerous energy when used inappropriately Manual Mode is intended for use only by authorized operators who have been specifically trained in cardiac rhythm recognition and in manual defibrillation therapy e Possible misinterpretation of ECG data The frequency response of the LCD display is intended for basic ECG rhythm identification it does not provide the resolution required for pacemaker pulse identification or accurate measurements such as ORS duration and ST segment interpretation For such purposes an ECG Monitor with an appropriate frequency response should be used e Follow voice prompts if the LCD screen becomes blank or unreadable 2 3 A CAUTIONS Conditions hazards or unsafe practices that may result in minor personal injury damage to the DDU 2000 Series AED or loss of data e Follow all battery pack labeling instructions Do not install battery packs after the expiration date e Follow all defibrillation pad label instructions Use defibrillation pads prior to their expiration date Do not re use de
72. on available upon request 57 DAC E2510EN BA 11 2 Battery Packs Use only Defibtech battery packs in the DDU 2000 Series AED DBP 2003 and DBP 2013 Battery Packs DBP 2003 Model number oe DBP 2013 Aviation TSO C 142a Wein barernd 12VDC 2800 mAh Lithium Manganese Dioxide EE Disposable recyclable non rechargeable 125 shocks or 8 hours of continuous operation AED Mode e 4 seconds or less from shock advised Charge time Manual Mode e 9 seconds or less 150 J e 12 seconds or less 200 J Standby lfe installed in unit Typical new battery at 25 C typical new battery depleted by 6 shocks at 25 C 11 3 Self Adhesive Defibrillation Pads Use only Defibtech defibrillation pads with your DDU 2000 Series AED Defibtech self adhesive defibrillation pads have the following characteristics lt 55 Ibs 25kgs 50 om each nominal Expiration date 2 5 years from date of manufacture 2 5 years from date of manufacture Note n the event of a suspected pad defect the pads should be clearly marked Not for Use and returned to Defibtech LLC for analysis Refer to Chapter 14 of this manual for contact information regarding returns 11 4 ECG Monitoring Adapter Cable Optional For use only with DDU 2400 and DDU 2450 AEDs Type CF fully defibrillation protected Lead type Placement Patient lead wire designation z 3 Negative White RA Right arm Reference Black LA Yellow L Left a
73. on shockable rhythm the user is prompted to perform CPR For shockable rhythms the AED automatically charges in preparation for shock delivery The patient analysis system will detect electrical noise or artifact in the ECG signal that may interfere with accurate rhythm analysis This artifact may be caused by excessive motion to the patient or by external electrical noise When this artifact is present the AED will prompt the user to Stop motion or Stop Interference until the ECG signal is free of noise and then proceed to analysis 56 DAC E2510EN BA 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 uVolts A Some very low amplitude or low frequency VF rhythms may not be interpreted as shockable WARNING Ventricular Tachycardia Including ventricular flutter and polymorphic VT Cardiac rhythm rate of at least 180 bpm and peak to peak amplitude at least 200 uVolts A Some very low amplitude or low frequency VT rhythms may not be interpreted as shockable WARNING The DDU 2000 Series AED is designed to recommend no shock for all other rhythms including Normal Sinus Rhythms fine Ventricular Fibrillation lt 200 uVolts and some slow
74. on with video instruction To exit press the softkey button again Opening The Defibrillation Pads Package Remove the pads package from the pad storage slot at the back of the AED Open the pads package by tearing along the dotted line starting at the black arrow follow directions on the package Check that the pads are e Free from obvious signs of damage e Clean of excessive debris for example dirt if the pad was dropped e Not dried out and that the gel is sticky and will adhere to the patient e Not expired Do not use pads after the expiration date printed on the package If any of these conditions are found use a new set of pads if possible 20 DAC E2510EN BA 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 Follow the directions and diagram showing proper defibrillation pad placement located on the defibrillation pads package and on the pads Peel off each pad from the blue liner before placing it as shown on the picture on the pad Peel the pad off the blue liner only when the pad is ready to be placed on the patient Place the pads with the sticky side of the pad on the patient s skin Pad placement on
75. ormation on operator training 1 1 Overview The DDU 2000 Series AED is a Semi Automatic External Defibrillator AED that is designed to be easy to use portable and battery powered It has two primary user controls the ON OFF and SHOCK buttons along with three softkey buttons for advanced mode features Voice prompts text prompts and a display screen with visual prompts provide a simple interface for the operator The DDU 2000 Series AED is capable of recording event information including ECG audio data optional and SHOCK NO SHOCK recommendations The DDU 2000 Series of AEDs includes the following models e DDU 2300 Operates in AED Mode e DDU 2450 Operates in AED Mode includes patient ECG display and ECG monitor mode using an optional ECG Monitoring Adapter e DDU 2400 Operates in AED Mode or Manual Mode includes patient ECG display and ECG monitor mode using an optional ECG Monitoring Adapter In AED Mode when connected to a patient who is unconscious and not breathing the DDU 2000 Series AED performs the following tasks e Prompts the operator through audio text and video prompts to prepare the patient for treatment e Automatically analyzes the patient s ECG e Determines whether a shockable rhythm is present e Charges the defibrillation capacitor and arms the SHOCK button if the AED detects a shockable rhythm e Prompts the operator to press the SHOCK button when the device is ready and a shock is recom
76. own below AHA LABELS DAC 2020 IEC LABELS DAC 2021 RA Right Arm R Right LA Left Arm L Left LL Left Leg F Foot 30 DAC E2510EN BA 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 00 01 13 00 00 48 p AN an S a A Ze E Neen Ke Ach AN LAA JA P Monitoring Plug In Rescue Pads ECG Monitor Mode Screen Shockable rhythm detected If a shockable rhythm is detected the defibrillator prompts Plug in Rescue Pads e Confirm the patient s condition Not responsive Not breathing No signs of circulation e Remove the ECG Monitoring Adapter and connect the defibrillation pads Rescue Pads to the AED e Apply the defibrillation pads to the patient s chest keeping them at least 2 5 cm one inch away from the ECG monitoring electrodes If necessary remove the ECG monitoring electrodes e Follow the AED s voice and onscreen text prompts 31 DAC E2510EN BA 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 freq
77. pired Replace the pads immediately 33 DAC E2510EN BA 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 If any cracks or other signs of damage are visible remove the AED from service and contact an authorized service center Replacing Pads The Defibtech defibrillation pads are intended for one time use only The pads must be replaced after each use or if the package has been damaged The DDU 2000 Series AED defibrillation pads are supplied in a sealed pouch with the connector and part of the cable exposed The DDU 2000 Series 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 DO NOT remove the defibrillation pads from the sealed A package until the pads are to be used The packaging should be opened only immediately prior to use otherwise CAUTION the pads may dry out and become non functional STEP 1 nspect The Pads First check to ensure that the pads package has not expired Do not use pads past their expiration date Discard expired pads
78. pply lines IEC 61000 4 4 1 kV for input output lines 1 kV line s Surge to line s IEC 61000 4 5 2 kV line s to earth Not applicable Battery operated equipment Not applicable Battery operated equipment Voltage dips short interruptions and voltage variations on power supply Not applicable Not applicable Battery operated equipment input lines IEC 61000 4 11 Power frequency magnetic fields Power frequency 50 60 Hz magnetic should not be greater than levels field IEC 61000 4 8 characteristic of a typical location in a commercial or hospital environment 60 DAC E2510EN BA Electromagnetic Immunity continued Portable and mobile RF communications equipment should be used no closer to any part of the 10 V m DDU 2000 Series including cables 80 MHz to than necessary The recommended Radiated RF 2 5 GHz separation distance calculated IEC 61000 4 3 from the equation applicable to the 80 5Hz AM frequency of the transmitter is shown Modulation in the following table Interference may occur in the vicinity of equipment marked with this symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 26 957
79. ptions include the AHA ERC 2010 protocol or Custom Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to Rescue protocol AED Main Menu gt Rescue options gt Rescue protocol What it does The Rescue protocol option allows the user to select between up to two rescue protocols that have been enabled in the unit The factory default setting of the rescue protocol is AHA ERC 2010 To change the protocol press the CENTER softkey button to highlight the protocol The user will be prompted to enter a password to proceed The password may be obtained from your medical director or from Defibtech For Defibtech contact information please refer to the Contacts section in Chapter 14 Once the password has been entered the user may select between the two protocols To enter the password use the TOP softkey button to scroll through numbers Once the correct number appears use the CENTER softkey button to move to the next space Once all of the numbers have been entered press the CENTER softkey button The user will now be able to choose a different rescue protocol i st Settings Before you begin Be sure the unit is in Maintenance Mode To enter Navigate to Settings AED Main Menu gt Rescue options gt Settings 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 impor
80. quirements and other relevant provisions of Directive 1999 5 EC Applicable standards are listed in the Environmental section in Chapter 11 of this manual 62 DAC E2510EN BA 13 Glossary Of Symbols E e Bei ER e V A Ba High voltage present SHOCK Button De ON OFF Button e Turns the device O e Turns the device O ivers defibrillation shock to the patient when the device is ready to shock when it is OFF FF when it is ON Caution consult accompanying documents Do not expose to high heat or open flame Do not incinerate Recyclable Consult operating instructions o instruction manual booklet damage or crush Follow proper disposal procedures Meets the requirements of the European Medical Device Directive Note XXXX represents the identification number of the notified body Temperature limitation Use by yyyy mm Defibrillation proof Can withstand the effects of an externally applied defibrillation shock Internally powered with defibrillatorproof BFtype patient applied parts per EN 60601 1 Manufacturer Date of manufacture 63 DAC E2510EN BA Glossary Of Symbols continued Do not reuse For USA users only Catalogue number Keep dry Handle with care Transportation and storage requirements See environmental requirements Authorized European Representative CAFE Does not contain latex Der femme IP 55 Dus
81. re not past expiration dates Check that the ASI is flashing green Comments Inspection by initials or signature 37 DAC E2510EN BA 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 Unit will not turn on Battery pack not inserted Insert battery pack Battery pack depleted or needs servicing Replace battery pack or call for service Unit needs servicing Call for service Unit immediately turns off Battery pack depleted Replace battery pack Unit needs servicing Call for service ASI flashes red and or unit makes periodic beep sound ASI does not flash at all Power on test failed service code xxxx Unit needs servicing Go to AED Status Screen by pressing the CENTER softkey button or call for service Battery pack non functional Replace battery pack Defibrillation pads are not pre connected to unit Connect defibrillation pads to unit Defibrillation pads or battery pack expired Battery pack not inserted Replace expired component Insert battery pack Battery pack is low or
82. rm Typical lead connection Lead Il Performance with EE i DDU 2400 2450 AED Meets environmental specifications for DDU 2000 Series 58 DAC E2510EN BA 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 6 Defibtech Event Viewer 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 XP and newer versions Minimum system requirements for adequate performance are as follows e Pentium 4 processor 512 MB system memory 1 GB free space on hard disk USB 1 0 connectivity 11 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 When recycling used disposable electrodes follow local clinical procedures Pack
83. rnal review by inserting a blank DDC card into the unit and following the Data Download procedure Refer to the Downloading The Internal Data Log section in Chapter 10 of this manual A Using non Defibtech Data Cards DDC cards CAUTION ou damage the unit and will void the warranty 49 DAC E2510EN BA 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 5 ECG Monitoring Adapter An optional ECG Monitoring Adapter cable DAC 2020 2021 may be used with the DDU 2400 2450 AED to provide a non diagnostic ECG display of the patient s heart rhythm for attended patient monitoring The adapter uses the same connector socket in the AED used by the defibrillation pads 50 DAC E2510EN BA 10 Event Viewing This chapter includes information about Defibview Defibtech Data Cards DDC cards and downloading internal data logs 10 1 Defibview Defibview is aWindows 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 Defibview serves the following primary functions e Enables emergency care personnel to review a cardiac episode from the time the AE
84. ry is past its expiration date it should be taken out of service and replaced as soon as possible Follow the instructions in the nstalling And Removing The Battery Pack and Connecting The Pads sections of Chapter 3 in this manual to replace an expired part with an unexpired part Pads should be discarded Battery packs should be appropriately recycled You may also check the status of pads and battery pack when the unit is off by pressing the center softkey button to display the AED Status Screen and enter Maintenance Mode Refer to the AED Status Screen section in Chapter 8 of this manual Checking The Defibtech Data Card DDC card If One Is Installed Each time the DDU 2000 Series AED is used an event file is created on the DDC card if installed If the unit was used to treat a patient the Defibtech Data Card DDC card in the unit should be removed and provided to the patient s care provider A new DDC card should be installed before the next use To remove the DDC card ensure the AED is OFF Locate the data card USB port access door on the right hand side of the unit Open the data card USB port access door by slightly pushing and then sliding the door down to release the latch The door will spring open To remove the DDC card press the card in as far as it will go and then release Upon release the DDC card will be partially ejected and can be removed by pulling the DDC card the rest of the way out To insta
85. s The following section provides brief descriptions of some of the voice and text prompts that the user will hear and see in AED Mode General Prompts Call for help Call For Help Purpose As soon as the DDU 2000 Series 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 Pediatric mode Pediatric Mode Purpose This informs the user that child infant pads are attached to the unit Child infant pads should only be used if the patient is an infant or a child under the age of 8 or less than 55 pounds 25kgs For children 8 years or older or over 55 pounds 25kgs and for adults adult pads should be used Do not delay therapy to determine exact age or weight Training pads Training Pads Purpose This informs the user that training pads are attached to the unit Training pads are used for training purposes only and will not deliver a shock In a rescue immediately replace the training pads with defibrillation pads Purpose This informs the user that the unit is turning off Pad Connection Pad Application Related Prompts Follow instructions to apply pads Follow Instructions Purpose This instructs the user to follow the AED prompts in order to apply the pads to the patie
86. s inserted Manual Self Tests Manually initiated self tests may be run at any time by the user to test the DDU 2000 Series AED s systems including the charging and shocking functions the shock is internally dissipated i e no voltage will be present at the pads To run a manually initiated AED test the unit must be put into Maintenance Mode Refer to the AED Maintenance Screen section in Chapter 8 of this manual for detailed information on performing these self tests Note Running a manually initiated self test will consume approximately one shock s worth of energy from the battery 7 3 Cleaning After each use clean the DDU 2000 Series 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 Also applies to ECG Monitoring Adapter DAC 2020 2021 e The battery pack should be installed when cleaning the DDU 2000 Series AED e Do not immerse the DDU 2000 Series AED in fluids or allow fluids to enter the unit e Do not spray cleaning solutions directly on the unit or its connectors e Do not use abrasive materials or strong solvents such as acetone or acetone based cleaning agents e To wipe the DDU 2000 Series AED s case clean use a soft cloth dampened with one of the following recommended cleaning agents Soapy water Ammonia based cleaners e g Windex Formula 409 Fantastik Hydrogen peroxide Isopropyl
87. solated Defibrillator AED Mode Waveform Impedance Compensated Biphasic Truncated Exponential Adult 150 Joules nominal 15 delivered into a 50 ohm load Child Infant 50 Joules nominal 15 delivered into a 50 ohm load Charge control Automatic by Patient Analysis System 4 seconds or less from shock advised Energy arge time Charge time may increase at the end of battery life and for temperatures below 10 C Charge time from the initiation of rhythm analysis to Meets or exceeds AAMI DF80 and IEC 60601 2 4 requirements readiness for discharge Charge time measured from initially switching power on to Meets or exceeds AAMI DF80 and IEC 60601 2 4 requirements charge ready eo e SHOCK button flashing Charge complete indication ee e Press flashing shock button voice prompt Shock delivery Shock is delivered by a single SHOCK button e f Patient Analysis System decides rhythm is no longer shockable or e Within 30 seconds after charge complete if operator has not pressed Automatic SHOCK button DISARM or e f defibrillation pads are removed from patient or unplugged from unit e f operator presses and holds the ON OFF button for approximately two Manual i sit as seconds device will disarm and turn off Typical new battery at 25 C 52 DAC E2510EN BA Defibtech DDU 2000 Series AED continued Defibrillator Manual Mode DDU 2400 only User selectable 25 50 70 100 150
88. t 17 DAC E2510EN BA Overview continued Unit Video Display Screen During AED Mode Battery Indicator gt Rescue Breathing Options Softkey Icon Information Main Screen gt P A a lt Softkey Icon Mode Select em 7 Ss neg Softkey Icon Text Prompts Give 30 Compressions lt 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 Text Prompts Ihe Text Prompt Area displays text prompts to guide the user during a rescue Softkey Buttons not pictured The Softkey Buttons are located to the right of the display screen If a softkey button is active it will have a softkey icon displayed next to it The softkey buttons are used to navigate menus or select actions Rescue Breathing Options Softkey Icon When this icon is present on the screen during a rescue the user may press the corresponding softkey button to select CPR coaching with compressions only no breathing or CPR coaching with compressions and breathing Information Softkey Icon When this icon is present on the screen the user may press the corresponding softkey button for additional information with video instruction The additional information is context dependent topics include preparing the patient and performing CPR To exit press the s
89. t 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 Lithium Manganese Dioxide Battery Product is not sterile J Defibrillation proof Can withstand the effects of an externally applied defibrillation shock Internally powered with defibrillatorproof CFtype patient applied parts per EN 60601 1 64 DAC E2510EN BA 14 Contacts Manufacturer Defibtech L L C peal 741 Boston Post Road Guilford CT 06437 USA activex forever IMPROVING OUTCOMES IMPROVING LIVES Scottsdale www ActiveForever com Peoria 10799 N 90th Street 9299 W Olive Avenue Scottsdale AZ 85260 1 800 377 8033 Suite 604 Peoria AZ 85345 480 767 6800 S 623 215 8470 F 602 296 0297 Sales ActiveForever com T 623 215 8471 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 This product and its accessories are manufactured and sold under license to at least one or more of the following United States patents 5 591 213 5 593 427 5 601 612 5 607454 5 611 815 5 617853 5 620 470 5 662 690 5 735 879 5 749 904 5 749 905 5 776 166 5 800 460 5 803 927 5 836 978 5 836 9
90. tant information regarding the protocol 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 You can obtain this code from your medical director or from Defibtech For Defibtech contact information please refer to the Contacts section in Chapter 14 Once the code has been entered the settings will have been changed To enter the code use the TOP softkey button to scroll through numbers letters Once the correct number letter appears use the CENTER softkey button to move to the next space Once all of the numbers letters have been entered press the CENTER softkey button The settings will have been changed based on the code entered 47 DAC E2510EN BA 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 gt Rescue options gt 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 The AED will now use that default view setting Note The factory default s
91. tep on cards purchased with your DDU 2000 Series AED A This step will erase all data on the data card WARNING 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 section in Chapter 3 of this manual 43 DAC E2510EN BA To enter Navigate to Format data card AED Main Menu gt AED maintenance gt 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 Note f the 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 formatting the data card it will automatically return to the AED Maintenance menu screen Using non Defibtech Data Cards DDC cards CAUTION 2Y damage the unit and will void the warranty Run Application From Card Run application from card will initiate a card application on the Defibtech Data Card DDC card The most typical application is a software upgrade Before you begin Be sure th
92. tery pack is inserted into the battery pack opening on the back of the AED and latches into place Battery packs are not rechargeable 9 3 Data Cards The DDU 2000 Series AED is designed to optionally use Defibtech Data Cards DDC cards The AED will operate with or without a DDC card but if a DDC card is installed additional event storage capacity is available The DDU 2000 Series AED accepts DDC cards capable of recording an assortment of data for a given period of time The DDU 2000 Series allows the user to enable or disable recording of audio data Refer to the AED Options Screen section in Chapter 8 of this manual The DDC card is inserted into a slot behind the data card USB port access door found on the side of the AED Refer to the Installing The Defibtech Data Card DDC card section in Chapter 3 of this manual A new event file is created on the DDC card each time the AED is turned on and the following information is recorded e The time the AED was turned on e Other data such as ECG data time data audio data audio enabled card only event milestones such as motion detection shock advice shock delivery information Multiple events may be recorded ona single DDC card If the DDC card becomes full the AED will stop recording to the card however the most critical event documentation for the current session will still be recorded internally Internally recorded event information can be downloaded for exte
93. ther accessories are detailed in the DDU 2000 Series AED Accessories section Before getting started identify each component and ensure that your package is complete DDU 2000 Series AED Battery Pack Defibrillation Pads Package Defibtech Data Card DDC card optional Defibtech DDU 2000 Series Automated External Defibrillator DDU 2300 DDU 2400 DDU 2450 i i User Manual SE SC on Defibtech Y E User CD Operating Guide 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 This allows the pads to be stored in a pre connected state for rapid deployment during an emergency DO NOT open the sealed pads package until the A 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 WARNING Note The DDU 2000 Series AED is designed to be stored with the pads connector already installed This simplifies the procedure for deploying and operating the device in an emergency First check to ensure that the pads package has not expired The expiration date is printed on the pad pouch and is also reported on the AED status screen Do not use pads past expiration date Discard expired pads 13 DAC E2510EN BA Connecting The Pads continued Insert the connector end of the defibrillation pad cable into t
94. ther a rhythm is shockable or non shockable or if analyzing is interrupted for some reason Do not touch the patient Do Not Touch Patient Purpose The DDU 2000 Series AED is trying to analyze the patient s heart rhythm The operator should not touch the patient This prompt will be spoken at the beginning of the analysis period and also if motion or interference has been detected Analyzing interrupted Analyzing Interrupted Purpose The DDU 2000 Series AED has determined that accurate ECG analysis is not possible and has ceased analyzing The operator is prompted to resolve the problem Refer to the Votion Interference Prompts and the Pad Connection Pad Application Related Prompts section in this chapter Once the problem is resolved the unit will enter analysis mode again No shock advised No Shock Advised Purpose The DDU 2000 Series AED has determined that a shock is not required The unit will NOT charge and the SHOCK button will NOT be enabled The user will be prompted to begin CPR Shock advised Shock Advised Purpose The DDU 2000 Series AED has determined that a shock is recommended and the unit will begin charging in anticipation of delivering a defibrillation shock Shock Related Prompts Charging Charging Purpose The DDU 2000 Series AED has determined that a shock is recommended and is charging the unit in anticipation of a defibrillation shock Analysis will continue duri
95. tkey Button Icons The presence of an on screen icon located directly to the left of a softkey button indicates that the softkey is functional Menu Options The list of options available from a particular menu Use the top or bottom softkey buttons to scroll through the list of options Select an option by pressing the center softkey button once an option is highlighted with a box 8 2 Navigation in Maintenance Mode The three softkey buttons located to the right of the display screen are used to navigate in Maintenance Mode Typical functions of the softkey buttons are the following Top softkey button Scroll up Center softkey button Select highlighted option Bottom softkey button Scroll down When a menu option is highlighted and then selected typically by pressing the CENTER softkey button either another screen will be displayed with additional menu options or an action will be performed Exiting Maintenance Mode To exit Maintenance Mode and return to Rescue Mode scroll to and select Rescue now or simply turn the unit off and then back on To exit Maintenance Mode and turn the unit off scroll to and select Turn AED off or simply turn 40 the unit off by pressing the ON OFF button DAC E2510EN BA 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 Result The unit wi
96. trical shock hazard and potential damage to that equipment 11 DAC E2510EN BA WARNINGS continued e 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 e 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 e CPR during analysis can cause incorrect or delayed diagnosis by the patient analysis system e Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis especially if very low amplitude or low frequency rhythms are present If the patient is being transported stop vehicle before beginning ECG analysis e In patients with cardiac pacemakers the DDU 2000 Series 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 e During defibrillation air pockets between the skin and defibrillation pads can cause patient skin burns To help prevent air pockets make sure self adhesive defibrillation pads completely adhere to the skin Do not use dried out or expired defibrillation pads Userinitiated and aut
97. uency 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 1 Routine Unit Maintenance Although the DDU 2000 Series AED is designed to be very low maintenance simple maintenance tasks must be performed by the owner operator on a regular basis to ensure the unit s dependability Check that the Active Status Indicator ASI is flashing green Check the condition of the unit and accessories Run manually initiated self test Replace pads Check pad and battery pack expiration dates Check the DDC card if one was installed Note f the unit has been dropped mishandled or abused a manually initiated self test should be performed Checking The Active Status Indicator The Active Status Indicator ASI is located to the right of the ON OFF button of the DDU 2000 Series AED and indicates the operational readiness state of the unit The ASI will periodically flash green to indicate that the unit is ready for use Ready for use means that the DDU 2000 Series has passed the most recent self test scheduled or user initiated If it is flashing red solid red or not flashing at all the AED needs service Anytime the ASI is flashing red the unit will periodically emit two beeps to call attention to it If the ASI is not flashing at all the
98. y fit in one way if the battery pack does not fit rotate the battery pack before trying again Once fully inserted the battery pack surface should be flush with the back of the AED Within moments of insertion the DDU 2000 Series AED will turn on and run a battery pack insertion self test When the test is completed the unit will report the status of the battery pack and shut down Afterwards the Active Status Indicator ASI adjacent to the ON OFF button of the DDU 2000 Series AED will periodically flash If the indicator flashes green the 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 the Checking The DDU 2000 Series AED Status section below for more details on the meaning of the indicator Note The battery pack must be removed from the unit for more than 10 seconds for the battery pack self test to be performed automatically To remove the battery pack push the battery pack eject release latch After the battery pack is partially ejected pull the battery pack out 3 5 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

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