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Defibtech DDU-100 Semi-Automatic External Defibrillator User Manual

1. 1 5 Operator Training Requirements eese 4 2 Dangers Warnings and Cautions ee ceeeeeeeeeee eene nennen nnn 5 2 1 Shock Fire Hazard Explosion eeseseee mmn 5 VAEMEZITUHIJI 5 2 12 Battery Paek ans a n an E On AH Cien a COPEPHEHELERE ENTER 5 2 1 3 Usage Environment sn 2 14 Defibrillation Shock Delivery isses sisse enean nnne 6 215 Maititeahce ei EE ERR RR RHIHII 7 2 2 Improper Device Performance sssssesee meme 7 2 2 1 Usage Environment Au ri bee in E EORR TERES DR 7 22 2 C m sn 8 2 2 3 Patient Analysis iet eo A iei d 8 2 2 4 Shock Delivery id 225 UEnMbicmeet HG 9 23 GOnGral eC Tcp 9 3 Setting up the DDU 100 AED ee eeeeeeeeeeeen nennen nnn nnn nnn 11 EN MEO S 11 3 2 Installing the Data Card iiit ent reason nha tnn hia rianas enhn a e rra 12 3 3 Installing the Active Status Indicator 9V Battery ccccccceeeceeeeeeeeeeeneeees 12 3 4 Installing and Removing the Battery Pack 3 5 Connecting the Pads cs scere endi an Em Raw d DVEa ELA EV Ma ER dive 3 6 Performing Manually Initiated Self Tests ceeeeeeeeeeeeeeeee teen eeeeeeneeeeee 3 7 Storing the DDU 100 AED ds ssencencasicecuces seen e rues AEEY 4 Using the
2. Battery pack low voice prompt Unit will still operate to treat 9V battery low or missing patients replace 9V battery as Soon as possible Replace 9 volt battery voice prompt 34 DAC 510E EN AB Symptom Possible Cause Corrective Action ake sure pads connector Connector not in properly is oriented correctly and fully Plug in pads connector voice inserted prompt Pad connector broken Replace pads Unit s connector broken Return unit for servicing Pads not connected to patient Place pads on patient Apply pads to patient s bare Pads not making good connection to chest as shown voice prompt patient Check pad connection to patient Pads or pad cable damaged Replace pads Poor pad contact to patient Dry pads Replace pads or Press pads firmly voice prompt Partial pad connection Check that pads are placed securely on patient Check pads voice prompt Pads touching EN D Ue Stop motion voice prompt Patient motion has been detected Stop patient motion Stop interference voice External interference has been Stop external interference prompt detected isi M interrupted voice Motion or interference detected Stop motion or interference Patient s ECG rhythm changed No action necessary Shock cancelled voice prompt Shock button not pushed within 30 Push shock button within 30 seconds seconds Low battery insufficient to charge Replace battery
3. 9V battery is installed in the DDU 100 AED an LED indicator located in the corner of the unit actively indicates unit status If the unit is fully operational the Active Status Indicator ASI will blink green and if the unit needs attention the ASI will blink red Anytime the ASI blinks red and a good 9V battery is installed the unit will also beep periodically to call attention to itself The indicator is powered by a replaceable 9V battery in the battery pack If the 9V battery has discharged active status indication will not be available In this case the 9V battery should be immediately replaced to restore active status indication If only the 9V battery is depleted the DDU 100 AED will still be fully functional when turned on and can be used in the on state normally Off Battery pack not installed AED is defective or the 9V battery is discharged Install functional battery pack or replace the 9V battery in the battery pack Steady On green DDU 100 AED is ON and operating Active normally Status Blinking green DDU 100 AED is OFF and ready to operate normally Blinking red DDU 100 AED is OFF and the AED or battery pack needs attention Steady On red DDU 100 AED is ON and has detected an error Indicator 4 3 Turning on the DDU 100 AED Press the ON OFF button to turn the DDU 100 AED on The unit will emit a beep and all the LEDs will light up temporarily The ON OFF button will illuminate green anytime t
4. DDU 100 AED e eee eee eeeee eee eeeeeeenenseeeeeeneeenenene 17 AT OVGIVIOW M M ES 17 4 2 Checking DDU 100 AED Status ssessseeee mene 18 4 3 Turning on the DDU 100 AED isssse In emen nean 18 DAC 510E EN AB 4 4 Ptepatatlon oorr eoe yer enaa e nein nep EA ren vnnd ues Edd exb aaa 19 44 1 Callfor Help oi oe oir rei i he teen es 19 442 Preparing the Patient iinc eiu Fe ene elects 19 44 3 Opening the Pad Package ii anra 19 4 4 4 Connecting Defibrillation Pads to the DDU 100 AED 19 4 4 5 Applying Pads to the Patient enra nnne 20 44 6 Follow DDU 100 AED Prompts visioista nnn nennen nns 21 4 5 Heart Rhythm Analysis 4 6 Delivering the Shock 4 7 No Shock Required esses ementi emere 4 8 Post Shock CPHR uiii ete ee iedtoeicus aida aa a ez voseu guste uda Ree 4 9 Post Use Procedures 4 10 Operational Environment 5 Maintaining and Troubleshooting the DDU 100 AED 27 HNIC E 27 5 2 Routine Maintenance aree eedeecc ee ouo e ocio ko jesse ea R y nag ae nasa Calo era a RERO RERO 28 5 2 1 Checking Active Status Indicator 28 5 2 2 Checking the Condition of the Unit and Accessories sss 29 5 2 3 Running a Manually Initiated Self Test sssseennnn 29 524 Heplacing Pads ei ettet tad pet d ede Ete pep ke
5. Energy Delivered Ohms msec msec Joules 25 2 8 2 8 53 50 4 1 4 1 51 Z5 72 4 8 52 100 9 0 6 0 51 Pediatric Patient Impedance Phase A Duration Phase B Duration Energy Delivered Ohms msec msec Joules 25 4 1 4 1 35 50 5 8 3 8 47 75 5 8 3 8 51 100 72 4 8 53 8 1 5 Patient Analysis System The DDU 100 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 In an initial ECG signal conditioning stage ECG data are received and digital processing is done to remove baseline wander and high frequency noise An ECG signal processing stage identifies and removes artifacts from the patient s ECG signal artifacts may arise from a variety of sources including noise patient motion respiration muscular contractions and pacemakers If excessive artifacts inhibiting the DDU 100 AED Patient Analysis System from accurately determining the patient s ECG rhythm are present in the ECG signal the ECG signal processing system informs the user that interference and or motion has been detected The ECG signal processing stage also computes the ECG signal s power spectrum The ECG signal and the power spectrum data are then processed by the ECG signal analysis 45 DAC 510E EN AB 46 DAC 510E EN AB routines These routines perform both spectral and t
6. Standard Lithium Battery Pack Category Specification Model number DBP 1400 Main battery type 15VDC 1400 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable Capacity A new battery typically will provide 125 shocks or 8 hours of operating time at 25 C Charge Time fresh Pack Typically lt 9 seconds Shelf life prior to installation Typically gt 5 years Standby life after installation Typically up to 5 years Active Status Indicator ASI battery 9VDC 1200 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable ery shelf life prior to installation y gt 5 years ery standby life after installation y 1 year 52 DAC 510E EN AB 8 3 Self Adhesive Defibrillation Monitoring Pads Use only Defibtech Pads with your DDU 100 AED Defibtech self adhesive defibrillation monitoring pads have the following characteristics Category Specification Model number DDP 100 DDP 200P Type Adult Child 8 years Intended use Disposable Disposable Adhesion Self adhesive Self adhesive Active gel surface area 103 cm2 each nominal 50 cm2 each nominal Cable connector type Integrated Integrated Cable length 122 cm typical 122 cm typical Note n the event of a suspected pad defect the pads should be clearly marked Not for Use and returned to Defibtech L L C for analysis Refer to Contacts section for
7. be used without a 9V battery If needed a non lithium based 9V battery may also be used but standby status indication life will be reduced Once the fresh 9V battery is installed the battery pack status LED should periodically flash green to indicate a ready state If the indicator does not flash either the battery pack is defective or the 9V battery is discharged Once the battery pack is installed into the unit the DDU 100 AED s Active Status Indicator should flash green every five seconds 3 4 Installing and Removing the Battery Pack The lithium battery pack provides power to the DDU 100 AED Before inserting the battery pack into the AED the 9V lithium battery should be installed in the battery pack itself as described in the previous section In an emergency the battery pack can be used without a 9V battery but under normal operating conditions the 9V battery should be installed Do not install the battery pack after the expiration date printed on the label The battery pack is non rechargeable A green Active Status Indicator on the label side of the battery pack will blink periodically to indicate that the battery pack is ready for use If the status indicator is not blinking either the 9V status battery has discharged or the battery pack is not suitable for use If the indicator does not blink after a new 9V battery has been installed the battery pack should no longer be used and should be removed from service When the batt
8. delayed diagnosis by the patient analysis system Do not place adult defibrillation pads in the anterior posterior front back position A shock or no shock decision may be inappropriately advised The DDU 100 AED requires that the adult defibrillation pads be placed in the anterior anterior front front position Some very low amplitude or low frequency rhythms may not be interpreted as shockable VF rhythms Also some VT rhythms may not be interpreted as shockable rhythms 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 During analysis and from Shock Advised until Shock Delivered patient movement and vibration must be minimized A WARNING In patients with cardiac pacemakers the DDU 100 AED may have reduced sensitivity and not detect all shockable rhythms If you know the patient has an implanted pacemaker do not place electrodes directly over an implanted device 2 2 4 Shock Delivery A WARNING A WARNING 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 During defibrillation air pockets between the skin and defibrillation pads can cause patient skin burns To he
9. located inside the battery pack provides Active Status Indicator ASI power This auxiliary battery is used to provide standby indicator power independently of the main lithium battery contained in the battery pack allowing the main battery pack to have a significantly longer shelf and standby life The unit will operate without a 9V battery installed in the battery pack but active status indication will not be provided If no 9V battery is installed status can still be checked by turning the unit on Only a fresh 9V lithium battery should be used as a replacement Refer to the Maintenance section for more information on replacement batteries The 9V battery is installed into the battery pack in the 9V battery compartment To install remove the cover covering the 9V battery compartment by pushing on it sideways The cover will slide and detach from the battery pack Insert the 9V battery into the 9V battery compartment so that the contacts on the battery touch the contacts in the battery pack The orientation of the battery contacts is shown in a picture on the inside bottom of the 9V battery compartment Replace the 9V battery compartment door by placing it in the almost closed position and then sliding it A closed K 12 DAC 510E EN AB If the battery pack is stored outside the unit for an extended period of time removal of the 9V battery will extend the 9V battery s life Note that in an emergency situation the battery pack may
10. picture Place the second as shown pad over the ribs on the patient s left side below the left breast also as shown 4 4 6 Follow DDU 100 AED Prompts At this point the DDU 100 AED will check to make sure that the pads are well connected to the patient and that an adequate ECG signal is being received Do not touch the patient eliminate any patient movement and cease CPR at this time If there is a problem with the pad connection connector connection patient motion or other inter ference the AED will guide the operator with audible and visual prompts Visual prompts consist ing of flashing LEDs with associated labeling reinforce the audio prompts and aid in high ambient noise environments Pad related voice prompts Plug in pads connector This indicates that the DDU 100 AED has determined that the pads are not properly connected to the unit Check that the connector is fully inserted into the unit If the prompts continue try removing and reinserting the pads connector or try a new set of pads The check pads LED will flash red during this message Remove pads from package in back of unit This indicates that the user should remove and tear open the pad package located in the back of the unit Apply pads to patient s bare chest as shown This indicates that the DDU 100 AED has determined that the pads are not placed on the patient Place pads on the patient following instructions on the pad package If the prom
11. service and contact an authorized service center 5 2 3 Running a Manually Initiated Self Test The DDU 100 AED runs a Power On Self Test every time the unit is powered up to test the basic operation of the unit The unit also runs daily weekly and monthly automatic Self Tests when an operational 9V ASI battery is present The user may also run an extensive userinitiated Self Test at any time To initiate the manually initiated Self Test with the unit off press and hold the ON OFF button for at least five seconds until the AED enters into Self Test mode The unit will run tests for approximately 10 seconds and report its status before automatically shutting down 29 DAC 510E EN AB 30 DAC 510E EN AB Note The manually initiated Self Test can be aborted by pressing the ON OFF button again to turn the unit off The unit may then be immediately used to treat a patient Note Every time the manually initiated Self Test is run the unit does an internal shock test This test reduces the capacity of the battery pack by one shock 5 2 4 Replacing Pads The Defibtech defibrillation monitoring pads are intended for one time use only The pads must be replaced after each use or if the package has been damaged d The DDU 100 AED defibrillation monitoring pads are supplied in a sealed pouch with the connector and part of the cable exposed The DDU 100 AED is designed to be stored with the electrode cable already installed This allows
12. the DefibView documentation for a complete description of the application DefibView is available for download at the Defibtech website at www defibtech com 9 Glossary of Symbols Meaning High voltage present Refer to operating instructions User Manual SHOCK Button Delivers defibrillation shock to the patient when the device is ready to shock OPE ON OFF DISARM Button Turns the device ON when it is OFF Turns the device OFF when it is ON DISARMS the device when it is charged and then turns the device OFF Caution consult accompanying documents User Manual Do not expose to high heat or open flame Do not incinerate Recyclable Consult operating instructions Do not damage or crush A amp Li V A Follow proper disposal procedures Meets the requirements of the European Medical Device Directive ofN A ice N 55 DAC 510E EN AB 56 DAC 510E EN AB Temperature limitation Use by yyyy mm i p EgE3 e Defibrillation protected Type BF connection Date of manufacture Do not re use For USA users only Catalogue number Manufacturer and date of manufacture Wl EN Serial number 10 Contacts Defibtech L L C 741 Boston Post Road Guilford CT 06437 Tel 866 333 4241 Toll free within North America 203 453 4507 Fax 203 453 6657 Emails sale
13. while turning the unit on continue holding the ON OFF button down for at least five seconds The unit will run a series of Self Tests report the results and will automatically shut down If the DDU 100 AED is required for an emergency push the ON OFF button again to stop the Self Tests and shut the unit off and then push the button to turn the unit on in the normal operating mode again Note manually initiated Self Tests will use approximately one shock s worth of energy from the battery pack and running manually initiated Self Tests will reduce the usable capacity of the battery 27 DAC 510E EN AB 28 DAC 510E EN AB 5 2 Routine Maintenance Although the DDU 100 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 Monthly After Each Use Action Check that Active Status Indicator is flashing green Check the condition of the unit and accessories Run manually initiated Self Test Replace pads Check pads and battery pack expiration dates Check the DDC if one was installed 5 2 1 Checking Active Status Indicator The Active Status Indicator ASI is located in the upper corner of the DDU 100 AED and indicates the operational readiness state of the unit It will periodically flash green to indicate a fully functional condition If it is flashing red or not flashing at all the AED needs at
14. 6 075 369 6 438 415 6 441 582
15. 6 957 MHz to 27283 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 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 51 DAC 510E EN AB 8 2 Battery Packs 8 2 1 High Capacity Lithium Battery Pack Category Specification Model number DBP 2800 Main battery type 15VDC 2800 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable Capacity A new battery typically will provide 300 shocks or 16 hours of operating time at 25 C Charge time fresh pack Typically 6 seconds Shelf life prior to installation Typically gt 5 years Standby life after installation Typically up to 7 years note pre installation plus post installation total life of 10 years Active Status Indicator ASI battery 9VDC 1200 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable ASI battery shelf life prior to installation Typically gt 5 years ASI battery standby life after installation Typically gt 1 year 8 2 2
16. Defibtech DDU 100 Semi Automatic External Defibrillator User Manual Software V2 0 DAC 510E EN AB DAC 510E EN AB USE ONLY IF PATIENT IS UNCONSCIOUS UNRESPONSIVE VAN NOT BREATHING PUSH ON BUTTON FOLLOW VOICE PROMPTS IF INSTRUCTED PUSH SHOCK BUTTON DAC 510E EN AB DAC 510E EN AB Notices Defibtech shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material Information in this document is subject to change without notice Names and data used in the examples are fictitious unless otherwise noted 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 O 2010 Defibtech LLC All rights reserved Copyright questions should be directed to Defibtech For contact information refer to the Contacts section of this manual CAUTION Federal law USA restricts this device to sale by or on the order of a physician Contents 1 Introduction to the DDU 100 Series AED ee eseserreeeeeeA 1 1 1 OVerviQW e nnr a Jetuhaute a aaa ordi daaa ent fuas ta sns ANNETA 1 1 2 The Defibtech DDU 100 AED sssseessennenn nnne nennen nnns nnn 2 1 3 Indications oer nen 1 4 Contraindications
17. Y AGENT DEALER OR EPRESENTATIVE OF DEFIBTECH LLC IS AUTHORIZED TO AKE ANY REPRESENTATION ORWARRANTY CONCERNING THE DEFIBRILLATOR OR ITS ASSOCIATED ACCESSORIES EXCEPT TO REFER TO THIS LIMITED WARRANTY THE EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE DEFIBTECH LLC SHALL IN NO EVENT BE LIABLE FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND NCLUDING BUT NOT LIMITED TO EXEMPLARY DAMAGES SPECIAL PUNITIVE COMMERCIAL LOSS FROM ANY CAUSE BUSINESS INTERRUPTION OF ANY NATURE LOSS 4 DOUL DZU m ZU OF PROFITS OR PERSONAL LLC HAS BEEN ADVISED SUCH DAMAGES HOWEVE STATE LAW DOES NOT AL LIMITATION JURY EVEN IF DEFIBTECH OF THE POSSIBILITIES OF R OCCASIONED WHETHER BY NEGLIGENCE OR OTHERWISE UNLESS APPLICABLE LOW SUCH EXCLUSION OR 59 DAC 510E EN AB 60 DAC 510E EN AB Patents pending This product and its accessories are manufactured and sold under one or more of the following United States patents D514 951 6 955 864 D499 183 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 5 836 993 5 879 374 6 016 059 6 047212
18. art rhythm and that the operator should not touch the patient This message will be spoken at the beginning of the analysis period and also if motion or interference has been detected The do not touch patient LED will flash red during this message Analyzing interrupted This indicates that the DDU 100 AED has determined that accurate ECG analysis is not possible and has ceased analyzing The operator is prompted to resolve the problem see Follow DDU 100 AED Prompts section Once the problem is resolved the unit will enter analysis mode again The analyzing LED will not be illuminated during this message No shock advised This indicates that the DDU 100 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 if needed for a period of two minutes Shock advised This indicates that the DDU 100 AED has determined that a shock is recommended and the unit will begin charging in anticipation of a defibrillation shock Analysis will continue and the analyzing LED will continue to flash green 4 6 Delivering the Shock If the DDU 100 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 will continue to analyze the patient s heart rhythm If the unit detects that the heart rhythm has changed to one that does no
19. as detected a condition that requires operator attention B SHOCK button This button will flash when a shock is recommended push this button to deliver the shock to the patient This button is disabled at all other times C analyzing LED Light Emitting Diode This green LED flashes when the DDU 100 AED is analyzing the patient s ECG rhythm D do not touch patient LED This red LED flashes when the DDU 100 AED detects motion or other interference that prevents analysis of the signal or when the user should not be touching or moving the patient E check pads LED This red LED flashes when the DDU 100 AED detects that the pad connection to the patient is poor or pads are not applied F ON OFF button Push button to turn the DDU 100 AED on Push again to disarm and turn the AED off Pads connector port Insert Patient Pads Connector item O into this port to connect pads to DDU 100 AED Battery pack The battery pack provides a replaceable main power source for the DDU 100 AED Battery pack opening Insert the battery pack firmly into this opening until the latch clicks into place Battery pack eject button This button releases the battery pack from the DDU 100 AED To remove the battery pack push the button until the battery pack is partially ejected from the unit Active Status Indicator ASI When the unit is off this indicator blinks green to indicate the unit is fully operational and blinks red to ind
20. ations e Any additional training as required by the authorizing physician e Thorough knowledge and understanding of the material presented in this User Manual 2 Dangers Warnings and Cautions This chapter includes a list of danger warning and caution messages that relate to the Defibtech DDU 100 AED and its accessories Many of these messages are repeated elsewhere in this User Manual and on the DDU 100 AED or accessories The entire list is presented here for convenience DANGER Immediate hazards that will result in serious personal injury or death WARNING Conditions hazards or unsafe practices that may result in serious personal injury or death CAUTION Conditions hazards or unsafe practices that may result in minor personal injury damage to the DDU 100 AED or loss of data 2 1 Shock Fire Hazard Explosion 2 1 1 Electricity A Hazardous electrical output This equipment is for use only by qualified DANGER personnel 2 1 2 Battery Pack A Follow all battery pack labeling instructions Do not install battery packs after caution the expiration date A Lithium battery packs are not rechargeable Any attempt to recharge a lithium WARNING battery pack may result in fire or explosion A Do not immerse battery pack in water or other liquids Immersion in fluids may result in fire or explosion WARNING 5 DAC 510E EN AB gt WARNING gt CAUTION Do not attempt to recharge short circuit punctu
21. by pressing the battery pack eject button on the side of the unit The DDC card is located in a slot directly above the battery pack opening in the unit Note DDC is not required for the DDU 100 AED to operate Even if a DDC card is not installed basic essential information will still be recorded internally The AED will still operate properly even after a replace memory card message 5 3 Replacing the Lithium 9V ASI Battery The 9V ASI battery is located in the battery pack in the 9V battery compartment see figure To install remove the cover covering the 9V battery compartment by pushing on it sideways The cover will slide approximately a 1 4 inch and then can be detached from the battery pack Insert the 9V battery into the 9V battery compartment so that the contacts on the battery touch the contacts in the battery pack The orientation of the battery contacts is shown in a picture on the inside bottom of the 9V battery compartment Replace the 9V battery compartment door by reversing the process used to remove A the door 31 DAC 510E EN AB 32 DAC 510E EN AB If the battery pack is stored out of the AED for an extended period of time removal of the 9V battery will extend the 9V battery s life Note that in an emergency situation the battery pack may be used without a 9V battery If needed a non lithium based 9V battery may also be used but standby status indication life will be reduced Once the fresh 9V bat
22. ckable rhythm e Prompts the operator to press the SHOCK button when the device is ready and a shock is recommended Delivers a shock once the device has determined a shock is required and the SHOCK button has been pressed e Repeats the process if additional shocks are required The Defibtech DDU 100 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 The DDU 100 AED uses two self adhesive defibrillation monitoring pads to monitor ECG signals and if necessary to deliver defibrillation energy to the patient These pads also known as electrodes are provided in a single use disposable package The DDU 100 AED determines proper pad to patient contact by monitoring the impedance between the two pads impedance varies with the electrical resistance of the patient s body Visual and audio prompts inform the operator of possible problems with patient contact Voice prompts and visual DAC 510E EN AB 2 DAC 510E EN AB indicators communicate the status of the AED and of the patient to the operator The DDU 100 AED has two push button controls and several LED indicators Defibrillation energy is delivered as an impedance compensated biphasic truncated exponen
23. den pw EN 60601 1 2 2001 A1 2006 method EN 61000 4 3 1998 Level 3 EMC Immunity Field strength 10V m carrier frequency range 26 MHz to 1 GHz AM modulation 80 percent index at 3 frequencies 1 5 and 20 Hz 43 DAC 510E EN AB 8 1 3 Defibrillator Dweetom Oi eao Infant child 50 J nominal delivered into a 50 ohm load Typically 6 seconds with a fresh DBP 2800 battery pack and 9 seconds with a fresh DBP 1400 battery pack Charge time may increase at the end of battery life and for temperatures below 10 C e SHOCK button flashing Press Shock button voice prompt Charge time from shock advised Charge complete indication f Patient Analysis System decides rhythm is no longer shockable or Within 30 seconds after Charge complete if operator Automatic has not pressed SHOCK button or DISARM ea f f defibrillation pads are removed from patient or unplugged from unit f operator presses the OFF DISARM button at any time Manual o disarm and turns off the device 8 1 4 Waveform Specifications The DDU 100 AED delivers a 150J Biphasic Truncated Exponential waveform to patients with impedances ranging from 25 to 180 ohms va V max V min vt Y The waveform is adjusted to compensate for measured patient impedance Nominal phase times and energy delivered are shown in the tables below 44 DAC 510E EN AB Adult Patient Impedance Phase A Duration Phase B Duration
24. di vin 41 7 2 Downloading the Internal Data Log cccceeeceeeeeeeeeeteeeeeeeeeeeaeeeeeesaeees 42 8 Technical Specifications eee Lee e cere eere eere eren rennen nnn 43 8 1 Defibtech DDU 100 AED conicere ici ananas iene curn hama oa n nan nina anat 43 8 11 Physical 43 812 Environmental eie rir penu tone durar AeA a RARE eua EE aede uro Reto iE uu 43 8 13 Defibrillator sue eer EU eU ERR EE ERREUR 44 amp 14 Waveform Specifications o ed e is 44 8 15 Patient Analysis System sciret aret rana EREE ESEA ERRATEA ENEA 45 amp 15 1 Shockable Rhythmi Criteria ss ie deese epe erdt 46 8 15 2 Patient Analysis System Performance sss 47 8 16 Clinical SUImtlabyiuu aiii iiec diera b HA OR EVER AER AR E GU HER ER RRIA FER eae 47 amp 16 1 Background s e d pee ardet eu Pee ei e UE 47 81 62 Methods P 48 8 1 6 3 Results iacu mte o dr E e E bci bees 48 BOA CONCIUSION m 48 8 1 7 Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immun sis ee 8 2 Battery Pack eec ice oce ei rera ces esunweeddiecebecee seeni risainia eiae 8 2 1 High Capacity Lithium Battery Pack 8 2 2 Standard Lithium Battery Pack sisse einen 8 3 Self Adhesive Defibrillation Monitoring Pads 8 4 Defibtech Data Cards DDCs 8 5 JDefibVIQW i ic tuex raus izeu eno a oe
25. e applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Power frequency magnetic fields should not be greater than levels characteristic of a typical location in a commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the DDU 100 including cables than necessary The recommended separation distance calculated from the equation applicable to the frequency of the transmitter is shown in the following table Interference may occur in the vicinity of equipment marked with the following symbol o 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 27283 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 100 is used exceeds the applicable RF compliance level above the DDU 100 should be observed to verify normal operation If abnormal performance is observed addi
26. e below Biphasic Patients Monophasic Patients Number Number P Value Defibrillation Efficacy 1 shock lt 2 shocks lt 3 shocks 52 54 96 36 61 59 lt 0 0001 52 54 96 39 61 64 lt 0 0001 53 54 98 42 61 69 lt 0 0001 Patients defibrillated 54 54 100 49 58 84 0 003 ROSC 41 54 76 33 61 54 0 01 Survival to Hospital Admission 33 54 61 31 61 51 0 27 Survival to Hospital Discharge 15 54 28 19 61 31 0 69 8 1 6 4 Conclusion More patients were defibrillated with an initial biphasic shock than monophasic shock and ultimately the biphasic waveform defibrillated at higher rates than the monophasic waveform A higher percentage of patients achieved Return Of Spontaneous Circulation ROSC after biphasic shocks Rates of survival to hospital admission and discharge did not statistically differ between the two waveforms 8 1 7 Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immunity Electromagnetic conformity Guidance and manufacturer s declaration The DDU 100 is intended for use in the electromagnetic environment specified below The customer or the user of the DDU 100 should assure that it is used in such an environment Electromagnetic emissions RE emissions The DDU 100 uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nea
27. e pads are intended for one time use only and must be discarded after use or if the package has been opened 3 6 Performing Manually Initiated Self Tests Upon initial setup perform a manually initiated Self Test as described in the following paragraph Note a manually initiated Self Test will use approximately one shock s worth of energy from the battery pack and will reduce the usable capacity of the battery To run a manually initiated Self Test as the unit is being turned on press the ON OFF button for at least five seconds until the AED enters into Self Test mode In this mode the DDU 100 AED will run a complete set of internal tests including charge and discharge tests When the tests are completed the unit will report its status and shut off The unit may then be immediately used by pressing the ON OFF button again The manually initiated Self Test can be aborted by pushing the ON OFF button to turn the unit off In addition every time a battery pack with a non depleted 9V battery is inserted the unit runs a Battery Pack Insertion Self Test to test the battery pack When the test is completed the unit reports the status of the battery pack and shuts down The unit may then be immediately used 3 7 Storing the DDU 100 AED The DDU 100 AED preferably with pads attached should be stored in environmental conditions within range of the specifications refer to the Environmental section of Technical Specifications The unit
28. e 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 The check pads LED will flash red during this message 21 DAC 510E EN AB 22 DAC 510E EN AB Check pads This indicates that the pads are making improper contact with the patient or touching each other and that 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 The check pads LED will flash red during this message Pausing for CPR This indicates that 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 if needed for a two minute period Motion Interference related voice prompts Stop motion This indicates that the DDU 100 AED has detected motion in the patient Stop all patient motion including CPR in response to this message If the patient is being transported stop the vehicle to stop the motion The do not touch patient LED will flash red during this message Stop interference This indicates that the DDU 100 AED has detected interference on the ECG signal Eliminate any radio or electrical sourc
29. emporal analysis to assess the shape and character of the ECG power spectrum and to compute the patient s cardiac rate The arrhythmia detection process determines whether or not to advise shocking the patient by examining the outputs of these analyses once per second for a period of 5 to 7 seconds The arrhythmia detection process employs a number of parameters to determine if a rhythm is shockable 8 1 5 1 Shockable Rhythm Criteria When placed on a patient meeting the indications for use criteria the DDU 100 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 y Volts AN Warning Some very low amplitude or low frequency VF rhythms may not be interpreted as shockable Ventricular Tachycardia including ventricular flutter and polymorphic VT Cardiac rhythm rate of at least 180 bpm and peak to peak amplitude at least 200 pVolts A Warning Some very low amplitude or low frequency VT rhythms may not be interpreted as shockable The DDU 100 AED is designed to recommend no shock for all other rhythms including Normal Sinus Rhythms fine Ventricular Fibrillation 200 Volts and some slow Ventricular Tachycardias and Asystole 8 1 5 2 Patient Analysis System Performance Rhythm Class Shockable Rhythm Ventricular Fibrillation ECG Test Algorithm Performance Sample Specificatio
30. ep EH apa hee 30 5 2 5 Checking Pad and Battery Pack Expiration Dates sss 30 5 2 6 Checking the DDC If One Was Installed sse 31 5 3 Replacing the Lithium 9V ASI Battery suse 31 LE EET ITI T III TIT TTL TT 32 5 5 Sragen e D IET 32 5 6 Operator s Checklist eine ee rore eterna eu oa niea aea Ea YR Re soo YR Pee so oup pre 33 5 7 TWro bleshooting 2 noir ees Deux c xe sepe coto eyuoe eee gU etu E uxo euseu aA 34 LAEEUCIISM 36 6 DDU 100 AED Accessories ce elurlleieeiecieee nennen hann nra nana 37 6 1 Defibrillation Monitoring Pads eeeeeeenmH mm 6 2 Battery Packs iioc coner e pxe eue e oue rca ex unes ueu s Gkos aE 6 2 1 Battery Pack Active Status Indicator 6 2 2 Active Status Indicator Battery sss sisse nnne 6 3 Data Cards viiccvcccccectsstekescedcadevepenee ce setae aa ieia ar VAI RiMe s care 6 4 Recycling Information 6 4 1 Recycling Assistance 642 dici eree 6 4 3 PACKAGING A P 6 4 4 Notice to European Union Customers esses eerie tnnt 40 DAC 510E EN AB 7 Event Viewing c lerlullllllecieniecieee ener nna nre n en anra ars a anna nna n ran 41 7 4 Defibtech Data Cards eret be oro e oo S Rn voe FEY pon eg 1S Gu e euch Fo Ya De bed a Fo ru
31. ery pack is in the AED a beep will provide notice that the 9V battery s capacity is low and that the 9V battery should be replaced To insert the battery pack into the DDU 100 AED orient the battery pack so that the label faces up Make certain that the battery opening in the side of the AED is clean and clear of any foreign objects Insert the battery pack into the opening in the side of the AED Slide the pack all the way in until the latch clicks If the pack does not slide all the way in it is most likely inserted upside down Once fully inserted the battery pack surface should be flush with the side of the AED To remove the battery pack push the battery eject button on the side of the AED After the battery pack is partially ejected pull the battery pack out 13 DAC 510E EN AB 14 DAC 510E EN AB Within moments of insertion if a non discharged 9V ASI battery is installed the DDU 100 will turn on and run a battery pack insertion self test The unit will automatically shut off after the test is run Afterwards the Active Status Indicator on the top corner of the DDU 100 AED will periodically flash if a nondischarged 9V ASI battery was previously installed in the battery pack If the indicator flashes green the AED and battery pack are functioning properly if the indicator flashes red there is a problem Refer to the Checking DDU 100 AED Status section for more details on the meaning of the indicator 3 5 Con
32. es 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 The do not touch patient LED will flash red during this message Pausing for CPR This indicates that 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 if needed for a two minute period 4 5 Heart Rhythm Analysis Once the DDU 100 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 the pad connections and will abort analysis if it detects any pad problems It will also continue to monitor for excessive motion or interference and will abort analysis if those conditions are detected Analysis related voice prompts Analyzing heart rhythm This indicates that the DDU 100 AED is actively analyzing the patient s ECG signal The AED will continue analyzing until it has determined whether a rhythm is shockable or non shockable or analyzing is interrupted for some reason The analyzing LED will flash green during this period Do not touch the patient This indicates that the DDU 100 AED is trying to analyze the patient s he
33. g the charging process or after the AED has been charged the operator may disarm the unit by pressing the ON OFF button 4 7 No Shock Required If the DDU 100 AED ECG analysis algorithm has determined that a shock is not required it will not charge the unit and the SHOCK button will not be enabled The operator will be prompted to begin CPR if needed for a period of two minutes The unit will not be monitoring the patient s ECG rhythm during this two minute CPR period During this two minute period the AED will not advise the user to stop motion even if motion is present During the two minute period the AED will announce time remaining in 15 second intervals At the end of the two minute period the unit will enter normal Analyzing mode No Shock Required Voice Prompts It is safe to touch the patient This indicates that the DDU 100 AED analysis algorithm has determined that no shock is required The unit will not charge and the SHOCK button will not be enabled The user will be prompted to begin CPR if needed for a period of two minutes The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Check airway Check breathing This indicates that the user should check the condition of the patient in order to determine if it is appropriate to perform CPR If needed begin CPR This indicates that the user should begin CPR if needed for two minutes The unit will not be monit
34. ge The expiration date of the battery pack is printed on the label on the pack The battery pack should be removed and replaced by this date when the battery pack is used up the unit will indicate low battery or replace battery and will flash the Active Status Indicator red Once an accessory is past its expiration date it should be replaced immediately Follow the instructions in the Installing and Removing the Battery Pack and Connecting the Pads sections to replace the part with an unexpired part Patient pads should be discarded Battery packs should be appropriately recycled e To remove the DDC card press the DDC in all the way and then release The DDC will be partially ejected and can be removed by pulling it the rest of the way out To install a new DDC insert the DDC label side up in the thin slot on the top of the opening for the battery pack The card should click into place and be flush with the surface of the slot If the card does not push in all the way it may have been inserted upside down In that case remove the card flip it over and try inserting it again 5 2 6 Checking the DDC If One Was Installed Each time the DDU 100 AED is used an event file is created on the DDC if installed If the unit was used to treat a patient the DDC in the unit should be removed and provided to the patient s care provider A new DDC should be installed before the next use To remove the DDC first remove the battery pack
35. he AED is on Voice prompts will guide the operator in the use of the unit To turn the unit off press the button again The Active Status Indicator ASI will indicate the state of the unit ASI off or blinking The device is OFF Press green ON OFF button to turn the device ON ON OFF ASI on green The device is ON Press green ON OFF DISARM button to turn device OFF ASI on red An error has been detected and unit will turn off automatically 18 DAC 510E EN AB 4 4 Preparation 4 4 1 Call for Help As soon as the AED is turned on the unit will prompt the user to call for help This indicates that the first step in a rescue should always be to contact professional emergency services If another person is available the user should direct that person to call for help and then continue the rescue without delay 4 4 2 Preparing the Patient Prepare the patient by removing any clothing from the patient s chest Wipe away moisture from the chest 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 electrode pads fully contact the patient s skin check that no jewelry or other objects are directly underneath where the pads will be placed 4 4 3 Opening the Pad Package Remove the pad package from the pad storage slot at the back of the AED Open the pad package by tearing along the dot
36. he DDU 100 AED has fully charged that the heart rhythm analysis algorithm still indicates 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 23 DAC 510E EN AB e Off No Shock indicated Button is disabled pressing the button will do nothing Flashing Shock is recommended The device is charged and ready to shock Button is enabled Press the button to administer shock 24 DAC 510E EN AB Shock x delivered This indicates that the DDU 100 AED has delivered the shock The x indicates the number of shocks that have been delivered since the unit was turned on note if the unit delivers more than 15 shocks during one on period the count will get reset to one on the sixteenth shock After each shock the AED will enter Post Shock CPR mode see below Shock cancelled This indicates that the DDU 100 AED has aborted shock mode and internally discharged 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 Note The DDU 100 AED will not automatically deliver a shock the user must press the SHOCK button Note At any time durin
37. hichever is earlier The limited warranty for all other accessories is for a period of one 1 year from the date of purchase or to the expiration date whichever is earlier LIMITED WARRANTY LIMITATIONS This limited warranty does not cover damage of any sort resulting from but not limited to accidents improper storage improper operation alterations unauthorized service tampering abuse neglect fire flood war or acts of God Additionally this limited warranty does not cover damage of any sort to the defibrillator or its associated accessories resulting from the use of the defibrillator with unapproved accessories or use of the accessories with unapproved medical devices The defibrillator and its associated accessories are not warranted to be compatible with any other medical device LIMITED WARRANTY VOIDED The limited warranty is immediately voided if the defibrillator or its associated accessories are serviced or repaired by any entity including persons not authorized by Defibtech LLC specified maintenance is not performed the defibrillator is used with one or more unauthorized accessories the associated accessories are used with an unauthorized defibrillator or the defibrillator or associated accessories are not used in accordance with Defibtech LLC approved instructions EXCLUSIVE REMEDY At Defibtech LLC s sole discretion Defibtech shall have the option to repair replace or provide a credit In the event
38. icate unit needs attention from the user or servicing Patient pads The defibrillation monitoring pads that are placed on the patient The pads may be stored in the pad storage area on the back of the unit Defibtech Data Card DDC This optional plug in card provides enhanced storage capabilities to the DDU 100 AED Active Status Indicator ASI battery This is a 9V lithium battery that provides power to the Active Status Indicator It is inserted into a compartment in the battery pack Patient pads connector Insert into Pads Connector Port item G to connect pads to the DDU 100 AED 3 DAC 510E EN AB 4 DAC 510E EN AB 1 3 Indications The DDU 100 AED is indicated for use on victims of sudden cardiac arrest SCA when the patient is e Unconscious and unresponsive e Not breathing For patients under 8 years old use child infant electrode pads Do not delay therapy to determine exact age or weight The DDU 100 AED must be used by or on the order of a physician 1 4 Contraindications The DDU 100 AED should not be used if the patient shows any of the following signs e Conscious and or responsive Breathing e Has a detectable pulse 1 5 Operator Training Requirements In order to safely and effectively operate the DDU 100 AED a person shall have met the following requirements e Defibtech DDU 100 AED and or defibrillation training as required by local state provincial or national regul
39. information on defect returns 8 4 Defibtech Data Cards DDCs Use only Defibtech Data Cards in the DDU 100 AED Defibtech Data Cards are available as follows Standard DDCs Model Number Details DDC 6 Up to 6 hours of ECG data DDC 12 Up to 12 hours of ECG data Audio enabled DDCs Model Number Details DDC 50AE Up to 50 minutes of Audio and 1 hour of ECG data DDC 100AE Up to 1 hour and 40 minutes of Audio and ECG data Note The DDU 100 will attempt to log at least an hour of ECG data if possible In audio enabled DDCs audio logging will be turned off if needed to preferentially record ECG information If a partially filled DDC is used it is possible that only ECG i e no Audio will be logged Every time the unit is turned on a file is created on the DDC the DDC card can hold a maximum 255 files Once a card is completely filled with data or files all DDC logging will stop but selected internal ECG logging will continue 53 DAC 510E EN AB 54 DAC 510E EN AB 8 5 DefibView DefibView is a PC based application program that allows review of ECG data and other patient and device performance parameters after an emergency event DefibView runs on various Windows platforms including Windows 98 Windows 2000 and Windows XP Minimum system requirements for adequate performance are as follows e Pentium II Processor at 300 MHz e 32 Mbyte System Memory 100 Mbyte free space on hard disk Refer to
40. ing mode and the analyzing LED will flash 4 8 Post Shock CPR If the DDU 100 AED has delivered a shock the unit will require a mandatory two minute CPR period No patient ECG rhythm monitoring will be done during this period Once the two minute period is complete the AED will continue in Analyzing mode Post Shock CPR Voice Prompts It is safe to touch the patient This indicates that it is safe for the user to touch the patient The unit will not be monitoring the patient s ECG rhythm during this required two minute CPR period The do not touch patient LED will be off to indicate that it is safe to touch the patient 25 DAC 510E EN AB Begin CPR now This indicates that the user should perform CPR for two minutes The unit will not be monitoring the patient s ECG rhythm during this required two minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue for x seconds or Continue for 1 minute x seconds This indicates that the user should continue performing CPR for x more seconds or for 1 minute and x more seconds respectively The unit will not be monitoring the patient s ECG rhythm during this required two minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue This indicates that the user should continue performing CPR This phrase is sp
41. ion Before getting started identify each component and ensure that your package is complete e DDU 100 AED i Battery pack Defibtech Data e 9V lithium battery Card DDC optional Defibrillation pad package User Manual User Manual 11 DAC 510E EN AB 3 2 Installing the Data Card The Defibtech Data Card DDC is used to store event and audio information collected by the AED All DDU 100 AEDs will operate IX without DDCs and will still store critical event information internally Different DDC versions store different amounts of information DDCs are available in versions that store and don t store audio information Refer to the DDC technical specification for exact storage capabilities DDCs may be reviewed with a separate PC based software package see Event Viewing section To install the DDC remove the battery pack and push the DDC label side up into the thin slot in the side of the AED centered over the battery pack opening The card should click into place and be flush with the surface of the slot If the card does not push in all the way it may have been inserted upside down In that case remove the card flip it over and try inserting it again To remove the DDC press the card in all the way and then let go The DDC will be partially ejected and can be removed by pulling it the rest of the way out 3 3 Installing the Active Status Indicator 9V Battery A userreplaceable lithium 9V battery
42. is experiencing Service required This indicates that the DDU 100 AED has detected an internal error is non operational and needs servicing Battery pack low This indicates that the battery pack capacity is low and should be replaced soon The AED will still be able to deliver at least a minimum of six defibrillation shocks the first time this message is spoken Replace battery pack This indicates that the battery pack is almost discharged and that the AED may not be able to deliver defibrillation shocks The battery pack should be replaced immediately Replace 9 volt battery This indicates that the 9V battery in the battery pack needs to be replaced The unit may not provide active status indication during standby mode in this condition but the AED is still fully functional when turned on and may be used to treat patients The 9V battery should be replaced as soon as possible Pads missing This indicates that pads were not found connected during a self test 5 2 2 Checking the Condition of the Unit and Accessories Inspect the device for dirt and contamination especially in the connector socket and around the battery pack opening Refer to the Cleaning section for guidance on cleaning your AED Inspect the device visually for damage Look for cracks or other signs of damage on the case especially near the connector socket and joints If any cracks or other signs of damage are visible remove the AED from
43. l face of the battery pack and is used to indicate battery pack status A periodically blinking green LED indicates that the battery pack status is OK and the battery pack is ready for use Absence of a blinking green LED indicates a battery pack problem or a depleted or missing 9V battery Refer to the Checking DDU 100 AED Status section for information on battery pack LED indications 6 2 2 Active Status Indicator Battery 6 3 Data Cards The Active Status Indicator ASI battery is a 9V lithium battery It provides power to the Active Status Indicator to prevent the main defibrillation battery from being depleted for non essential functions This provides a significantly longer standby life for the AED and battery pack and extends the lifetime during which the DDU 100 AED can deliver defibrillation shocks The Active Status Indicator battery is a lithium 9 volt battery DDU 100 AED is designed to optionally use Defibtech Data Cards DDC The AED will operate with or without a DDC but if a DDC is installed additional event storage capacity is available The DDU 100 AED accepts DDC cards of different capacities each designed to record an assortment of data for a given period of time For example the DDU 100 AED can record more than ten hours of ECG only or approximately one hour and forty minutes of audio and ECG data on a large DDC card Cards are available with and without audio logging enabled The DDC is inserted int
44. l refer the unit for servicing Symptom Possible Cause Corrective Action Battery pack not inserted nsert battery pack Battery pack depleted or non functional Replace battery pack it is non functional Return unit for service tery pack depleted Replace battery pack Unit immediately turns off it is non functional Return unit for service ASI is solid red Unit detected an error Run manually initiated Self Test 9V battery low Replace ASI 9V battery needs Servicii Turn unit on and run manually 9 initiated Self Test ASI blinks red ery pack non functional Replace battery pack to m padsare not preconniecieg Connect electrode pads to unit 9V battery depleted ace ASI 9V battery ery pack not inserted rt battery pack ASI does not blink at all ery pack non functional Replace battery pack Unit is non functional Return unit for service ni Power on self test failed M Record code number and return z P n Unit needs servicing e service code xxx unit for servicing Battery pack self test failed Battery pace needs servic Record code number and replace service code xxx yp 9 with new battery pack Unit will probably not deliver ery pack capacity is critically low a shock replace battery pack immediately Replace battery pack voice prompt Unit will still deliver shocks ery pack capacity is getting low replace battery pack as soon as possible
45. lot in the back of the DDU 100 AED After connecting the pads connector to the unit push the pad package with the pictures on the package facing up and out rounded end first into the pad holder compartment on the back of the AED When the pad pack is fully inserted press the pad cable into the groove in the back of the unit to hold it in place and tuck any excess cable behind the pad package 4 4 5 Applying Pads to the Patient 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 pad package by tearing the package along the dotted line near the top of the package Remove the pads from the package and follow the directions and diagram showing proper defibrillation pad placement located on the defibrillation pad package Peel off the protective backing from each pad before placing it as shown on the picture on the pad Peel the backing off only when the pad is ready to be placed Place the pads with the sticky side of the pad on the patient s skin Pad placement on infants or children under 8 years is different than placement for adults or children 8 years or older Place the pads as shown in the diagram s For adults and children 8 years or older use adult For infants and children under 8 use child infant pads Place one pad just below the patient s right pads Place one pad in the center of chest and back collar bone as shown in the
46. lp prevent air pockets make sure self adhesive defibrillation pads completely adhere to the skin Do not use dried out or expired defibrillation pads 2 2 5 Maintenance A WARNING AN WARNING A CAUTION 2 3 General A CAUTION Periodic userinitiated and automatic self tests are designed to assess the DDU 100 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 Use of damaged equipment or accessories may cause the device to perform improperly and or result in injury to the patient or operator Improper maintenance can cause the DDU 100 AED not to function Maintain the DDU 100 AED only as described in this User Manual The AED contains no user serviceable parts do not take the unit apart Federal law USA restricts this device to sale by or on the order of a physician 9 DAC 510E EN AB 10 DAC 510E EN AB 3 Setting up the DDU 100 AED This chapter describes the steps required to make your Defibtech DDU 100 AED operational The DDU 100 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 100 AED Replacement and other accessories are detailed in the DDU 100 AED Accessories sect
47. nals to review the data For details about the features and use of the application refer to the DefibView documentation 7 1 Defibtech Data Cards If a DDC is installed in the unit every time the DDU 100 is turned on the following information is recorded on a new file on the card 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 41 DAC 510E EN AB 42 DAC 510E EN AB 7 2 Downloading the Internal Data Log Regardless of whether a DDC is installed in the unit select information is recorded internally within the DDU 100 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 Eight seconds of ECG data immediately before a shock no shock decision eight seconds immediately after each shock and all ECG data during the charging and waiting to shock periods e Note Audio data is not logged internally To download the internally logged information perform the following procedure Insert a blank DDC into the unit Turn the unit on Once the unit is on turn it off in data download mode by pushing and holding the ON OFF button for at least five seconds e Allow the unit to w
48. necting the Pads The DDU 100 AED defibrillation monitoring pads are supplied sealed in a pouch with the connector and part of the cable exposed This allows the pads to be stored in a pre connected state for rapid deployment A during an emergency Caution DO NOT remove the defibrillation pads from the sealed package until the pads are to be used The packaging should be opened only immediately prior to use otherwise the pads may dry out and become non functional Note The DDU 100 AED is designed to be stored with the pads connector already installed This simplifies the procedure for setting up and operating the device in an emergency First check to ensure that the pad package has not expired Pads past their expiration date should not be used and should be discarded Insert the connector end of the defibrillation pad cable into the pads connector port on the top left corner of the DDU 100 AED as shown Insert pads connector firmly until it is fully seated in the unit The connected pad package can then be stored in the pad storage slot in the back of the DDU 100 AED After connecting the pads connector to the unit push the pad package with the pictures on the package facing out rounded end first into the pad holder compartment on the back of the AED When the pad 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 pad package Caution Th
49. ns Size 90 Lower 2 Performance Confidence Limit2 Meets the AAMI DF39 requirement and AHA recommendation2 of Sensitivity gt 90 Shockable Rhythm Ventricular Tachycardia Non Shockable Rhythm Normal Sinus Rhythm Meets the AAMI DF39 requirement and AHA recommendation of Sensitivity 7596 Meets the AAMI DF39 requirement of Specificity gt 95 and the AHA recommendation of Specificity 9996 Non Shockable Rhythm Asystole Meets the AAMI DF39 requirement and the AHA recommendation of Specificity 9596 Non Shockable Rhythm All other non shockable rhythms Meets the AAMI DF39 requirement and the AHA recommendation of Specificity 9596 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 8 1 6 Clinical Summary The DDU 100 AED uses a Biphasic Truncated Exponential waveform with specifications that are substantially equivalent below The DDU 100A 8 1 6 1 Background to the waveform specifications of the device used in the study cited ED has not been the subject of a published clinical study The objecti
50. o a slot above the battery pack opening in the AED refer to the Installing the Data Card section A new and initialized DDC card should be used each time the AED is operated to maximize recording time A new event file is created on the DDC each time the AED is turned on and the following information is recorded DDC cards may contain a maximum of 255 event files e The time the AED was turned on e Other data such as ECG data time data audio data audio enabled card only e Event milestones such as motion detection shock advice shock delivery information When an audio enabled DDC gets low on available storage the AED will stop recording the less critical audio data to allow room for additional ECG data in an attempt to record at least one hour of ECG total recording time is limited by available space on the DDC Data from a previous event will NOT be erased If the DDC fills completely the AED will still be operable and the most critical event documentation for the current session is still recorded internally Internally recorded event information can be downloaded for external review by inserting a blank DDC into the battery pack and following the data download procedure refer to the Downloading the Internal Data Log section 6 4 Recycling Information At the end of its useful life recycle the defibrillator and its accessories 6 4 1 Recycling Assistance For recycling assistance contact your local Defibtech distribut
51. of replacement Defibtech shall have the right at its sole discretion to replace the item with a new or refurbished same or similar item Determination of a similar item shall be at the sole discretion of Defibtech In the case of replacement the replacement at a minimum shall reflect the prorated time remaining for the item based on the remaining limited warranty period In the case of a credit the credit shall be the prorated value of the item based on the lower of the original item cost of the same or similar item and the remaining limited warranty period In no event shall the limited warranty period of a replacement item extend past the limited warranty period of the item it is replacing WARRANTY SERVICE In order to obtain warranty service contact the retailer from whom the item was purchased or Defibtech LLC customer service In the event an item must be returned a Return Material Authorization RMA number is required Items returned without an RMA number will not be accepted The item shall be shipped at the original end user s expense to a destination specified by the retailer or Defibtech LLC OBLIGATIONS AND WARRANTY LIMITS HE FOREGOING LIMITED WARRANTY IS IN LIEU OF D SPECIFICALLY EXCLUDES AND REPLACES TO THE EGREE PERMITTED BY APPLICABLE STATE LAW ALL THER EXPRESS OR IMPLIED WARRANTIES INCLUDING UT NOT LIMITED TO THE IMPLIED WARRANTIES OF ERCHANTABILITY AND FITNESS FOR A PARTICULAR URPOSE O PERSON INCLUDING AN
52. off e Check to make sure that the Active Status Indicator is flashing green 4 10 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 for a detailed list of approved environmental conditions 26 DAC 510E EN AB 5 Maintaining and Troubleshooting the DDU 100 AED This chapter describes the maintenance and troubleshooting procedures for the DDU 100 AED The Self Tests that are performed by the device are described along with the frequency and nature of periodic maintenance for which the owner operator is responsible A troubleshooting guide is provided to help diagnose user serviceable problems The DDU 100 AED contains no user serviceable parts except for the ASI 9V battery 5 1 Self Tests Power On Self Tests are performed every time the unit is turned on and test the basic operation of the unit The unit also performs daily weekly monthly and quarterly self tests automatically when a non discharged 9V battery is present without any intervention from the operator to check the integrity of the unit s hardware and software Manually initiated Self Tests may be run to test the DDU 100 s systems including the charging and shocking functions the shock is internally dissipated i e no voltage will be present at the pads at any time To run a manually initiated Self Test
53. oken between the continue for x seconds or continue for 1 minute x seconds prompts 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 required two minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue for 5 4 3 2 17 Stop CPR This indicates that the user should finish performing CPR This phrase is spoken during the last several seconds of the required two minute CPR period to let the user know that the unit is still operating normally and the two minute period is ending Stop now Do not touch the patient This indicates that the mandatory two minute CPR period has ended and the user should stop CPR The unit will enter Analyzing mode and the analyzing LED will flash 4 9 Post Use Procedures After the DDU 100 AED has been used on a patient the unit should be cleaned following procedures in the Cleaning section and prepared for the next use The following steps should be performed e Remove battery pack Remove DDC if installed Replace with a new DDC Reinsert battery pack Check that the Battery Pack Insertion Self Test passes Connect a new pad package check to make sure the package is not expired Hold ON OFF button down for at least five seconds to initiate a manually initiated Self Test Unit will report status of the Self Test and shut
54. or Recycle in accordance with local and national regulations 6 4 2 Preparation Items should be clean and contaminant free prior to being recycled When recycling used disposable electrodes follow local clinical procedures 6 4 3 Packaging Packaging should be recycled in accordance with local and national requirements 39 DAC 510E EN AB 6 4 4 Notice to European Union Customers Pd The crossed out wheeled bin symbol SESS 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 national 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 Man
55. oring the patient s ECG rhythm during this two minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue for x seconds or Continue for 1 minute x seconds This indicates that the user should continue CPR if needed for x more seconds or for 1 minute and x more seconds respectively The unit will not be monitoring the patient s ECG rhythm during this two minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue This indicates that the user should continue CPR if needed This phrase is spoken between the continue for x seconds or continue for 1 minute x seconds prompts to let the operator know that the unit is still operating normally The unit will not be monitoring the patient s ECG rhythm during this two minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue for 5 4 3 2 17 Stop CPR This indicates that the user should finish performing CPR This phrase is spoken during the last several seconds of the two minute CPR period to let the operator know that the unit is still operating normally and that the two minute period is ending Stop now Do not touch the patient This indicates that the two minute CPR period has ended and the user should stop CPR The unit will enter Analyz
56. pack Run manually initiated Self Test Hardware failure se return unit for servicing Shock not delivered voice prompt Check that pads are placed Bad pad to patient connection securely on patient Dry pads Replace pads Replace DDC card with a card Replace memory card voice DDC card is full that is not full prompt DDC has failed Replace DDC card Make sure pads connector Pads missing voice prompt Pads not connected is oriented correctly and fully inserted into unit Unit makes periodic beep Unit has detected a condition that Turn unit on to run the power on sound needs user attention Self Test All indicator LEDs blinking unit Run manually initiated Self Test Hardware failure is does not operate return unit for servicing 35 DAC 510E EN AB 5 8 Repair The DDU 100 AED contains no user serviceable parts If the unit need servicing return to an authorized service center Refer to Contacts section for contact information 36 DAC 510E EN AB 6 DDU 100 AED Accessories This chapter describes the components and accessories that can be used with the Defibtech DDU 100 AED Information on obtaining replacement components and accessories is included in the Contacts section 6 1 Defibrillation Monitoring Pads The DDU 100 AED is used with Defibtech self adhesive defibrillation monitoring pads for adults or with attenuated pediatric pads for infants and children The
57. pts continue try replacing the pads with a new set The check pads LED will flash red during this message Plug in and apply pads This indicates that the DDU 100 AED has determined that the pads are not plugged in and not applied to the patient Check that the connector is fully inserted into the unit If the prompts continue try removing and reinserting the pads connector or try a new set of pads The check pads LED will flash red during this message Poor pad contact to patient Press pads firmly This indicates that the pads are not making proper contact with the patient and that the impedance is out of range for proper ECG analysis and shock delivery 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 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 The check pads LED will flash red during this message Replace pads This indicates that the pads are not making proper contact with the patient and that the impedance is out of range for proper ECG analysis and shock delivery If another set of pads is available replace the pads otherwise check that the pads are properly placed and fully adhering to the patient Make sur
58. rby electronic equipment The DDU 100 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions Not applicable IEC 61000 3 3 Electromagnetic immunity Immunity test IEC 60601 test Compliance level Electromagnetic environment level guidance Electrostatic discharge ESD 6 kV contact 6 kV contact The DDU 100 uses interference IEC 60601 4 2 8 kV air 8 kV air detected and motion detected indicators to notify the user if conditions are not ideal No other ESD requirements are necessary Electrical fast transient burst 2 kV for power line Not applicable IEC 61000 4 4 ply lines V for input output lines Surge x1 kV line s to Not applicable IEC 61000 4 5 line s x2 kV line s to earth 49 DAC 510E EN AB 50 DAC 510E EN AB Immunity test Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 IEC 60601 test level Not applicable Compliance level Not applicable Electromagnetic environment guidance Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2 5 GHz Note 1 At 80 MHz and 800 MHz the higher frequency rang
59. re or deform battery Do not expose battery to temperatures above 50 C 122 F Remove battery when depleted Recycle or dispose of lithium battery packs in accordance with federal state and or local laws To avoid fire and explosion hazard do not burn or incinerate the battery 2 1 3 Usage Environment gt DANGER gt DANGER gt CAUTION gt CAUTION Possible explosion hazard if used in the presence of flammable anesthetics or concentrated oxygen The DDU 100 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 100 AED is not to be used in the presence of flammable substance air mixtures Do not immerse any portion of this product in water or other fluids Do not allow fluids to enter the device Avoid spilling any fluids on this device or accessories Spilling fluids into the DDU 100 AED may damage it or present a fire or shock hazard Do not autoclave or gas sterilize the DDU 100 AED or its accessories The DDU 100 AED should be stored and used only within the range of environmental conditions specified in the technical specifications 2 1 4 Defibrillation Shock Delivery AN WARNING 6 DAC 510E EN AB Defibrillation current can cause operator or bystander injury Do not touch the patient during defibrillation Do not touch equipment connected to the patient or metal objects in contact
60. rite the contents of the internal log to the DDC by waiting for the unit to turn off automatically The DDU 100 will write the contents of the internal log onto the DDC This information can then be reviewed using the DefibView software 8 Technical Specifications 8 1 Defibtech DDU 100 AED 8 1 1 Physical Category Specification 8 5 x 11 8 x 2 inches 22 x 30 x 7 cm Approximately 4 2 Ibs 1 9 kg with DBP 1400 Battery pack Approximately 4 4 lbs 2 kg with DBP 2800 Battery pack 8 1 2 Environmental Category Specification Temperature 0 50 C 32 122 F Operating Maintenance Humidity 596 9596 non condensing Temperature 0 50 C 32 122 F Standby Storage Humidity 596 9596 non condensing 150 to 4500 meters 500 to 15 000 feet per MIL STD 810F 500 4 Procedure Il E 81 Di Shock Drop Abuse Tolerance MIL STD 810F 516 5 rocedure IV 1 meter any edge corner or surface in standby mode MILSTD 810F 514 5 Category 20 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 IEC 60529 class IP54 Splash Proof Dust Protected Battery pack installed Open air discharges up to 8 kV or direct contact discharges up to 6 kV EN 60601 1 2 2001 A1 2006 method EN 55011 1998 Group 1 Level B Not to exceed 30 dB uV from 30 Hz to 230 MHz and not to exceed 37 dB uV from 230 to 1000 MHz m oe a
61. s and the DDU 100 AED is recommended Although the DDU 100 AED is designed for a wide variety of field use conditions rough handling beyond specifications can result in damage to the unit 7 DAC 510E EN AB 2 2 2 Pads AN WARNING A CAUTION gt WARNING Use only Defibtech disposable self adhesive defibrillation monitoring pads battery packs and other accessories supplied by Defibtech or its authorized distributors Substitution of non Defibtech approved accessories may cause the device to perform improperly Follow all defibrillation pad label instructions Use defibrillation pads prior to their expiration date Do not re use defibrillation pads Discard defibrillation pads after use in the event of suspected pad malfunction return pads to Defibtech for testing 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 2 2 3 Patient Analysis gt WARNING gt WARNING gt gt WARNING gt WARNING 8 DAC 510E EN AB 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 CPR rates above the American Heart Association guidelines of 100 BPM beats per minute can cause incorrect or
62. s defibtech com Sales reporting defibtech com Medical Device Reporting service defibtech com Service and Repair European Authorized Representative Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 CE 0197 57 DAC 510E EN AB 58 DAC 510E EN AB 11 Warranty Information ORIGINAL END USER S LIMITED WARRANTY COVERAGE Defibtech LLC provides a limited warranty that the defibrillator and its associated accessories e g batteries and pads whether purchased concurrently with the defibrillator as part of a configuration or separately shall be substantially free from defects in material and workmanship Defibtech s limited warranty shall only extend to the original end user where the original end user purchased the items from an authorized Defibtech LLC retailer This limited warranty may not be assigned or transferred The terms of the Limited Warranty in effect as of the date of original purchase shall apply to any warranty claims LENGTH OFWARRANTY The defibrillator s limited warranty is for a period of five 5 years from the date of purchase The battery s limited warranty is for a period of four 4 years from the date of purchase but in no event shall the limited warranty period extend past the date printed on the battery Single use accessories e g the pads shall have a limited warranty up to use or for a period up to the expiration date w
63. s iu sicuv E ge susp ai uo slender eid adn 9 Glossary of Symbols ccc err cree ede eee o ianea nannini ren Ee sOSR Rn ROM EP 55 puc jcpcWwee c 57 11 Warranty lnformation eroe ee cree ir reed nne ete lessee 59 DAC 510E EN AB DAC 510E EN AB 1 Introduction to the DDU 100 Series AED This User Manual provides information to guide trained operators in the use and maintenance of the Defibtech DDU 100 series Semi Automatic External Defibrillator AED and its accessories This chapter includes an overview of the AED a discussion of when it should and should not be used and information on required operator training 1 1 Overview The DDU 100 AED is a Semi Automatic External Defibrillator AED that is designed to be easy to use portable and battery powered It has only two user controls the ON OFF and SHOCK buttons Voice prompts and visual indicators provide a simple interface for the operator The DDU 100 AED is capable of recording event information including ECG audio data optional and SHOCK NO SHOCK recommendations When connected to a patient who is unconscious and not breathing the DDU 100 AED performs the following tasks Prompts the operator to take necessary actions to enable analysis Automatically analyzes the patient s ECG Determines whether a shockable rhythm is present Charges the defibrillation capacitor and arms the SHOCK button if the AED detects a sho
64. se pads also known as electrodes serve two functions e Allow the unit to read the patient s electrocardiograph ECG rhythm Deliver defibrillation energy to the patient when needed The Defibtech self adhesive defibrillation monitoring pad assembly comes in a leads out sealed package that allows the device to be stored with pads connected When the DDU 100 AED is used the operator needs only to remove the pad packaging tear open the package and turn the device on to administer care The AED has a storage area in the back of the unit that allows for storage of a single sealed pad package 6 2 Battery Packs The Defibtech AED uses a lithium battery pack The battery pack contains the main lithium battery cells an LED status indicator and a 9V lithium battery Different capacity battery packs are available Refer to the Battery Packs section for detailed information on the available packs The battery pack is inserted into the battery pack opening on the side of the AED and latches into place 37 DAC 510E EN AB 38 DAC 510E EN AB The main battery is based on a lithium battery technology and provides the AED with a long shelf and standby life Battery pack status indication is provided by a blinking green status LED Status indicator power is supplied by a user replaceable 9V lithium battery 6 2 1 Battery Pack Active Status Indicator The battery pack s Active Status Indicator ASI is located on the labe
65. should also be stored so that the Active Status Indicator can be readily seen The Active Status Indicator should periodically blink with a green light If it blinks with a red light or does not blink at all the DDU 100 AED needs servicing refer to the Checking Active Status Indicator section for more information Defibtech recommends storing your AED in an easily accessible location 15 DAC 510E EN AB 16 DAC 510E EN AB 4 Using the DDU 100 AED This chapter describes how to use the DDU 100 AED The DDU 100 AED was designed for simple operation allowing the operator to focus on the patient There are only two control buttons and four light emitting diode LED indicators Concise and easily understandable voice messages and prompts guide the operator through the use of the unit The following sections describe in detail how to use the DDU 100 AED The basic steps for use are Turn the DDU 100 AED ON by pressing the ON OFF button Connect pads to AED if not yet connected Place pads on patient follow instructions on pad package Follow voice prompts Press SHOCK button if instructed by the AED 4 1 Overview Pad Active Status Connector PA Indicator defibtech_ _ ON OFF A Button QD check pads Indicator LEDs amp donot touch patient gt analyzing Shock Button Speaker 17 DAC 510E EN AB 4 2 Checking DDU 100 AED Status Once a fully functional battery pack with a non discharged
66. t require a shock the unit will abort the charging process and will prompt the user to begin CPR if needed for a period of two minutes Also while charging the AED will continue to monitor the pad connections and will abort charging if it detects any pad problems It will also continue to monitor for excessive motion or interference and will abort charging if those conditions are detected The user can abort at any time by pushing the ON OFF button to turn the unit off Shock related voice prompts Charging This indicates that the DDU 100 AED has determined that a shock is recommended and is charging the unit in anticipation of a defibrillation shock Analysis will continue during this phase and the analyzing LED will continue to flash green A tone will sound to indicate charging progress If the unit detects a rhythm change to a non shockable one charging will abort and the user will be prompted to begin CPR if needed for a period of two minutes Stand clear This indicates that the DDU 100 AED is charging and that the operator and others should stand clear of the patient Analysis will continue during this phase and the analyzing LED will continue to flash green A tone will sound to indicate charging progress If the unit detects a rhythm change to a non shockable one charging will abort and the user will be prompted to begin CPR if needed for a period of two minutes Press flashing shock button This indicates that t
67. tandard Power On Self Test 5 5 Storage The DDU 100 AED should be placed in a readily accessible location in an orientation where the Active Status Indicator in the upper corner of the unit 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 5 6 Operator s Checklist The following checklist may be used as the basis for an Operator s Checklist The table should be copied and filled out as recommend by the schedule in the Routine Maintenance section As each item is completed it should be checked off Defibtech DDU 100 Operator s Checklist Defibtech DDU 100 Serial Number Defibtech DDU 100 Location Date Check unit and accessories for damage dirt and contamination Clean or replace as necessary Check that spare battery pack and pads available Check that battery pack and pads not past expiration dates Check ASI flashing green Comments Inspection by initials or signature 33 DAC 510E EN AB 5 7 Troubleshooting The following table lists the common causes for problems the possible cause and the possible corrective actions Refer to the other sections of the User Manual for detailed explanations on how to implement the corrective actions If the unit continues to be non functiona
68. ted line starting at the black arrow follow directions on the package Pull the protective backing from the pads and check that the pads are Free from obvious signs of damage Clean of excessive debris for example dirt if the pad was dropped Not dried out and that the gel is sticky and will adhere to the patient Not expired Do not use pads after the expiration date printed on the package If any of these conditions is found use a new set of pads 4 4 4 Connecting Defibrillation Pads to the DDU 100 AED 6 The DDU 100 AED is designed to be stored with the defibrillation pad 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 pad connector plugged into 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 pad connector is on the corner of the AED To remove an old set of pads pull firmly on the pad connector Do not reuse used pads Insert the connector for the new pads as shown 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 19 DAC 510E EN AB 20 DAC 510E EN AB If not needed for immediate use the pad package can then be stored in the pad storage s
69. tention Anytime the ASI is flashing red and a good 9V battery is installed the unit will periodically emit a beep to call attention to itself If the ASI is not flashing at all the most likely cause is that the ASI 9V battery needs to be replaced Follow the directions in the Replacing the Lithium 9V ASI Battery section to replace the ASI battery Once the battery has been replaced with a fresh battery the ASI should once again flash green If it does not the battery pack may be defective In that event the battery pack should be replaced If it still does not flash after inserting a new battery pack the DDU 100 AED is non operational and needs servicing If the ASI is flashing red turn the DDU 100 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 the voice prompts will indicate the nature of the problem Maintenance Related Voice Prompts Power on self test failed service code xxx This indicates that the DDU 100 AED has failed the poweron self test and is non operational and needs servicing The code number will indicate to the service personnel the type of problem that the unit is experiencing Battery pack self test failed service code xxx This indicates that the DDU 100 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
70. tery is installed the battery pack status LED should periodically flash green to indicate a ready state If the indicator does not flash either the battery pack is defective or the 9V battery is discharged Once the battery pack is installed into the unit the DDU 100 AED s status indicator should periodically flash green Note The unit will operate without a 9V battery installed but active status indication and automatic self tests will not be provided Status can still be checked by turning the unit on 5 4 Cleaning Periodically clean the DDU 100 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 e The battery pack should be installed when cleaning the DDU 100 e Do notimmerse the DDU 100 in fluids or allow fluids to enter the unit Use a soft cloth to wipe the case clean e Do not use abrasive materials or strong solvents such as acetone or acetone based cleaning agents The following cleaning agents are recommended for cleaning the DDU 100 case and the connector socket o Soapy water o Ammonia based cleaners o Hydrogen peroxide o Isopropyl alcohol 70 percent solution o Chlorine bleach 30 ml liter water e Ensure that the connector socket is completely dry before reinstalling the pads cable After cleaning the device and before returning it to service always turn the unit on for a few seconds which will cause the unit to run a s
71. the pads to be stored in a pre connected state for rapid deployment during an emergency Caution DO NOT remove the defibrillation pads from the sealed package until the pads are to be used The packaging should be opened only immediately prior to use otherwise the pads may dry out and become non functional First check to ensure that the pad package has not expired Pads past their expiration date should not be used and should be discarded Insert the connector end of the defibrillation pad cable into the pads connector port on the corner of the DDU 100 AED as shown Press the pads connector in firmly until it is fully seated in the unit The pad package can then be stored in the pad storage slot in the back of the DDU 100 AED After connecting the pads connector to the unit push the pad package with the pictures on the package facing up and out rounded end first into the pad holder compartment on the back of the AED When the pad pack is fully inserted press the pad cable into the groove in the back of the unit to hold it in place and tuck any excess cable behind the pad package Caution The pads are intended for one time use only and must be discarded after use or if the package has been opened 5 2 5 Checking Pad and Battery Pack Expiration Dates It is important that the patient pads and the battery packs not be used past their expiration dates The expiration date of the pad package is printed on the outside of the sealed packa
72. tial waveform The device delivers 150 Joules into a 50 ohm load when using adult pads or when using attenuated child infant pads 50J of defibrillation energy into a 50 ohm load Energy delivered does not change significantly with patient impedance although the duration of the generated waveform will vary The Defibtech AED is designed to deliver up to 150J of defibrillation energy through a patient impedance range of 25 180 ohms or 50J of defibrillation energy when using the child infant pads Defibrillation and AED operating power is supplied by a replaceable non rechargeable lithium battery pack that provides for long standby life and low maintenance operation Battery packs are available in several configurations optimized for use in specific applications Each pack is marked with an expiration date The DDU 100 AED records event documentation internally and optionally on Defibtech Data Cards DDC The optional DDC plugs into a slot in the AED and enables the AED to record event documentation and audio audio enabled cards only if sufficient space is available on the card Audio recording is available only for units with installed audio enabled Defibtech Data Cards Event documentation stored internally can be downloaded onto a DDC for review 1 2 The Defibtech DDU 100 AED A Speaker The speaker projects the voice prompts when the DDU 100 AED is on The speaker also emits a beep when the unit is in standby mode and h
73. tional measures may be necessary such as reorienting or relocating the DDU 100 Separation Distances The DDU 100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the DDU 100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the DDU 100 as recommended below according to the maximum output of the communications equipment Recommended separation distances between portable and mobile RF communications equipment and the DDU 100 Separation distance according to frequency of transmitter m Rated maximum 150 kHz to 80 MHz 150 kHz to 80 MHz 800 MHz to 2 5 output power of outside ISM bands inside ISM bands GHz transmitter W d 1 16P d 1 2P d 2 3P 0 01 0 01 0 12 0 23 0 1 0 1 0 37 0 73 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 As 80 MHz and 800 MHz the separation distance for the higher frequency range applies 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 2
74. ufacturer 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 notwithstanding the limits imposed by the nature and the use of this device the manufacturer will do his best to develop recovery processes Please contact the local distributor for information 40 DAC 510E EN AB 7 Event Viewing DefibView is a Windows based software application that reads data stored on a DDC and displays it on a personal computer DefibView serves four primary functions e Enables emergency care personnel to reconstruct a cardiac episode from the time the AED was turned on and connected to the patient until the unit is turned off e Enables a patient s primary care giver to review the emergency episode e Allows Defibtech and regulatory personnel to reconstruct a cardiac episode for review of device performance e Provides maintenance personnel with additional parameter information to assist in troubleshooting a device suspected of malfunctioning DefibView is a stand alone software application It cannot be used with the AED in operation and exists solely to support post event review of the data recorded on a DDC or downloaded to a DDC from internal storage The DDC from an event should be transported to a medical facility with the patient allowing medical professio
75. ve of this study was to compare AEDs that delivered 150 J biphasic shocks with AEDs that delivered high energy 200 to 360 J monophasic shocks Schneider T Martens PR Paschen H et al Multicenter randomized controlled trial of 150J 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 47 DAC 510E EN AB 48 DAC 510E EN AB 8 1 6 2 Methods AEDs were prospectively randomized according to defibrillation waveform on a daily basis in four emergency medical services systems First responders used either the 150 J biphasic AEDs or 200 to 360 J monophasic waveform AEDs on victims where defibrillation was indicated A sequence of up to three defibrillation shocks was delivered 150J 150J 150J for the biphasic units and 200J 200J 360J for the monophasic units Defibrillation was defined as termination of VF for gt 5 seconds without regard to hemodynamic factors 8 1 6 3 Results Of 338 patients with an out of hospital cardiac arrest 115 had a cardiac etiology presented with ventricular fibrillation and were shocked with one of the randomized AEDs There were no statistical differences between the monophasic and biphasic groups in terms of age sex weight primary structural heart diseases cause or location of arrest bystanders who witnessed the arrest or type of responder A summary of the results is presented in tabl
76. with the patient during defibrillation Disconnect other electrical equipment from the patient before defibrillating Disconnect the DDU 100 AED from the patient prior to use of other defibrillators AN WARNING A WARNING A CAUTION Improper use can cause injury Use the DDU 100 AED only as instructed in the User Manual The DDU 100 AED delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly Do not discharge with defibrillation pads touching or gel surface exposed Disconnect all non defibrillator proof equipment from the patient before defibrillation to prevent electrical shock hazard and potential damage to that equipment 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 2 1 5 Maintenance A WARNING Electrical shock hazard Dangerous high voltages and currents are present Do not open unit remove covers or attempt repair There are no user serviceable components in the DDU 100 AED Refer servicing to qualified service personnel 2 2 Improper Device Performance 2 2 1 Usage Environment A WARNING A CAUTION Radio frequency RF interference from RF devices such as cellular phones and two way radios can cause improper AED operation In accordance with IEC 801 3 a distance of 2 meters 6 feet between RF device

Defibtech DDU-100 Semi-Automatic External Defibrillator User Manual

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