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Defibtech DDU-100 Semi-Automatic External Defibrillator User Manual

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1. Patient pads connector Insert into Pads Connector Port item G to connect pads to the DDU 100 AED 3 DAC 510E EN BF 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 e 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 regulations e Any additional training as required by the authorizing physician e Thorough knowledge and understanding of the material presented in this User Manual 4 DAC 510E EN BF 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 Immedi
2. 2 1 Shock Fire Hazard Explosion EEN 5 ZiT Elemtiert M 5 2 12 Battery Pak anana Ee EE 5 2 13 Usage Envirohmeht b rete EE IRE a Ale patate eee 6 2 14 Defibrillation Shock Delivery eese sisse ntn 6 2 15 Malriternalice ai ee d p tae RAT ana rt RR UE ERRARE ERE 7 2 2 Improper Device Performance eeesseeeeeeeeeeeenne nennen 7 2 2 1 Usage Environment reb Uva esi ee Evo REPE EORR EBENE EG 7 2 22 Pads sassen 8 2 2 3 Patient Analysis nete Ue pe Pede ica ad 8 22A Shock Delivery EE 9 2 2 5 Maintenance 2 3 CET 10 3 Setting up the DDU 100 AED see RENE ENEE ENEE ENEE EEN 11 Bil e TT 11 3 2 Installing the Data Cardis degegeebegE ENEE LEE erret notte tenens oen 12 3 3 Installing the Active Status Indicator 9V Battery eee 12 3 4 Installing and Removing the Battery Pack eee 13 3 5 Connecting the Pads niece imer testa suc n iata ace arabe kai iasi 14 3 6 Performing Manually Initiated Self Tests eeeeeeee 15 3 7 Storing the DDU 100 AED eeeeeseeeeeneeeenennnennennne enne nnne nnne 15 4 Using the DDU 100 AED iier ER paas pu iedeen aiani Redes 17 CAES TT 17 4 2 Checking DDU 100 AED Status REENEN 18 4 3 Turning on the DDU 100 AED esses enne tnn treten 18 V DAC 510E EN BF DAC 5
3. 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 To perform a manual Self Test begin with the unit powered off Press and hold the ON OFF button until the unit announces that it is performing a Self Test this should take approximately 5 seconds Once you hear the announcement release the ON OFF button The unit will prompt you to press flashing shock button When prompted press and release the flashing SHOCK button The unit will run a series of internal tests including charge and shock tests The manually initiated Self Test can be aborted by pressing the ON OFF button again to turn the unit off When the Self Test is complete the unit will announce its status and power off If the Self Test passes The unit will announce UNIT OK and power off The unit may then be immediately used by pressing the ON OFF button again If the Self Test fails The unit will announce the symptom The user should refer to the Troubleshooting section in Chapter 5 of this manual for appropriate action 29 DAC 510E EN BF 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 t
4. 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 The pads are intended for one time use only and must be discarded after use or if the package has been opened 14 DAC 510E EN BF 3 6 Performing Manually Initiated Self Tests Upon initial setup perform a manually initiated Self Test as described in the following paragraph To perform a manual Self Test begin with the unit powered off Press and hold the ON OFF button until the unit announces that it is performing a Self Test this should take approximately 5 sec
5. Specifications The unit 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 BF 16 DAC 510E EN BF 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 e Connect pads to AED if not yet connected Place pads on patient follow instructions on pad package Follow voice prompts e Press SHOCK button if instructed by the AED 4 1 Overview Pad Active Status Connector Ba Indicator defibtech ON OFF Button C check pads Indicator LEDs EH do not touch patient ECH analyzing Shock Button Speaker 17 DAC 510E EN BF 4 2 Checking DDU 100 AED Status Once a fully functional battery
6. active status indication and automatic self tests will not be provided Status can still be checked by turning the unit on 34 DAC 510E EN BF 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 Soapy water Ammonia based cleaners Hydrogen peroxide Isopropyl alcohol 70 percent solution 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 standard 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 stor
7. 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 has 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 sh
8. 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 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
9. fully adhering to the patient Make sure that the pads are not touching each other If the pads are not sticking due to moisture dry the patient If the pads are not sticking due to excessive hair shave or clip excessive chest hair If the prompts continue try replacing the pads with a new set The check pads LED will flash red during this message 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 sources of inter
10. 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 A WARNING 6 DAC 510E EN BF 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 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 A WARNING AN 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
11. 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 THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES TO THE DEGREE PERMITTED BY APPLICABLE STATE LAW ALL OTHER EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE NO PERSON INCLUDING ANY AGENT DEALER OR REPRESENTATIVE OF DEFIBTECH LLC IS AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANTY 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 A CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND INCLUDING BUT NOT LIMITED TO EXEMPLARY DAMAGES SPECIAL PUNITIVE COMMERCIAL L
12. the pads cable and replace if any nicks cuts or broken cables are found Insert the connector end of the defibrillation pad cable into the pads connector port on the corner of the AED as shown Press the pads connector in firmly until it is fully seated in the unit 32 DAC 510E EN BF 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 package 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 immediate
13. will illuminate green anytime the 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 e ASI off or blinking The device is OFF Press green ON OFF button to turn the device ON SEN e 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 BF 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 packag
14. 10E EN BF 44 Preparation ooo encre ementi eoi ete eei EECH 19 44 1 Call f r Help e 19 442 Preparing the Patient it i monet vp sov eta ee deu 19 44 3 Opening the Pad Package rrr ta FUR ER HR HARE 19 4 4 4 Connecting Defibrillation Pads to the DDU 100 AED 19 44 5 Applying Pads to the Patient nare ce EES Eee ug a ann 20 44 6 Follow DDU 100 AED Prompts eese sienten iine tnnt ntn nnns 21 45 Heart Rhythm Analysis ANEREN 22 4 6 Delivering the Shock eem trennen tnit dEEEeEdEEEEE KSE 23 AT No ShockRequited iei esae tit rere Ere bee eek rao eo va Pee FEN oe ERE EE ERR 25 4 8 Post Sliock CPR 5eiiieeeeitirnned ie EES citet nere antur arare seite Ee 26 4 9 Post Use Procedures ierit niente eone citetne cuite snnt ie iine sita noon ania EES 27 4 10 Operational Environment eseeeeeeeeeeeeeeenneennennnnnnenn nennen nenne 27 5 Maintaining andTroubleshooting the DDU 100 AED 29 5T Self Tests eiie eni eei etui crees ierit hate encanta ries 29 5 2 Routine Maintenance ei deer beh erede ce dera eed aaRS RESE 30 5 2 1 Checking Active Status Indicator eese 30 5 2 2 Checking the Condition of the Unit and Aocessories 31 5 2 3 Running a Manually Initiated Zelt Iesrt AA 32 5 24 Heplacing PAS sice cesecivazseezctececsescectssestactscencecaceeahest
15. 61 31 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 52 DAC 510E EN BF 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 Emissions test Compliance Electromagnetic environment guidance RF 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 nearby 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 immuni
16. DC 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 46 DAC 510E EN BF 8 Technical Specifications 8 1 Defibtech DDU 100 AED 8 1 1 Physical 8 5 x 11 8 x 2 7 inches 22 x 30 x 7 cm Approximately 4 2 Ibs 1 9 kg with DBP 1400 Battery pack Approximately 4 4 Ibs 2 kg with DBP 2800 Battery pack 8 1 2 Environmental 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 II e 81 Di Shock Drop Abuse Tolerance MILSTD 810F 516 5 rocedure IV 1 meter any edge corner or surface in standby mode L STD 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 Dust Protected Splash Proof Battery pack installed 61000 4 2 1998 Severity Level 4 Open air discharges up to 8 kV or direct contact discharges up to 6 kV 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 to exceed 37 dB uV from 230 to 1000 MHz 60601 1 2 2001 A1 2006 method EN 61000 4 1998 Leve
17. Defibtech DDU 100 Semi Automatic External Defibrillator User Manual ELECTRONIC DISTRIBUTION AHA ERC 2010 DAC 510E EN BF Iv DAC 510E EN BF 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 2013 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 se 1 je Tim M 1 1 2 The Defibtech DDU 100 AED ae 2 E WT E d eroe onmi ax eee Er neret sre deret t En Creer er IY HEU 4 1 4 Contraindicatioris 5 rni rerit tir Eire P Ee to Fei EP eer Eee REESEN EE ETE EH CE EUER 4 1 5 Operator Training Requirements eeeeeeeeeeeneenennenennnne nennen 4 2 Dangers Warnings and Cautions e eeeeeeeeeeeer eene nennen nnn 5
18. ED is designed to recommend a defibrillation shock when it detects proper pad impedance and one of the following Peak to peak amplitude at least 200 y Volts Ventricular Fibrillation AN Warning Some very low amplitude or low frequency VF rhythms may not be interpreted as shockable Cardiac rhythm rate of at least 180 bpm and peak to peak amplitude at least 200 pVolts including ventricular flutter and Warning Some very low amplitude or low frequency VT rhythms Ventricular Tachycardia polymorphic VT 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 50 DAC 510E EN BF 8 1 5 2 Patient Analysis System Performance Rhythm Class Shockable Rhythm Ventricular Fibrillation Shockable Rhythm Ventricular Tachycardia ECG Test Algorithm Performance Sample Specifications Size 90 Lower 2 Performance Confidence Limit Meets the AAMI DF39 requirement and AHA recommendation of Sensitivity gt 90 Meets the AAMI DF39 requirement and AHA recommendation of Sensitivity gt 75 Non Shockable Rhythm Normal Sinus Rhythm Meets the AAMI DF39 requirement of Specificity gt 95 and the AHA recommendation of Specificity gt 99 Non Shockable Rhythm Asystole Meets the AAMI DF39 requi
19. OSS FROM AN CAUSE BUSINESS INTERRUPTION OF ANY NATURE LOS OF PROFITS OR PERSONAL INJURY EVEN IF DEFIBTEC LLC HAS BEEN ADVISED OF THE POSSIBILITIES OF SUC DAMAGES HOWEVER OCCASIONED WHETHER BY NEGLIGENCE OR OTHERWISE UNLESS APPLICABLE STATE LAW DOES NOT ALLOW SUCH EXCLUSION OR LIMITATION lt Io XO Applicable to defibrillators and associated accessories having a date of manufacture on or after January 1 2013 For all others refer to warranty information in effect at the time of manufacture DAC 510E EN BF 65 activex forever IMPROVING OUTCOMES IMPROVING LIVES Scottsdale www ActiveForever com Peoria 10799 N 90th Street 9299 W Olive Avenue Scottsdale AZ 85260 1 800 377 8033 Suite 604 Peoria AZ 85345 p 480 767 6800 p 623 215 8470 f 602 296 0297 Sales ActiveForever com f 623 215 8471 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 6 075 369 6 438 415 6 441 582 66 DAC 510E EN BF
20. Replace 9 volt battery voice prompt 37 DAC 510E EN BF Possible Cause 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 Dry pads Replace pads Poor pad contact to patient or Press pads firmly voice prompt Partial pad connection Check that pads are placed securely on patient Check pads voice prompt Pads touching EDU PASA QE Stop motion voice prompt Patient motion has been detected Stop patient motion Stop interference voice External interference has been Stop external interference prompt detected Analyzing interrupted voice Motion or interference detected Stop motion or interference prompt 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 pack Run manually initiated Self Test Hardware failure n return unit for servicing Shock not delivered voice prompt Check that pads are placed Bad pad to patie
21. 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 43 DAC 510E EN BF 6 4 4 Notice to European Union Customers The crossed out wheeled bin symbol a 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 Manufacturer and author
22. ackage If the prompts 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 21 DAC 510E EN BF 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
23. age location are within the ranges detailed in the Environmental section 35 DAC 510E EN BF 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 36 DAC 510E EN BF 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 functional refer the unit for servicing Battery pack not inserted Insert battery pack Battery pack depleted or non functional Replace battery pack it is non functional Return unit for service ery pack depleted Replace battery pack Unit immediately turns off it is non functional Return unit for serv
24. 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 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 instal
25. asssdetcusssvas cxievaeedeeccissapecezes 32 5 2 5 Checking Pad and Battery Pack Expiration Dates sss 33 5 2 6 Checking the DDC If One Was Installed sse 33 5 3 Replacing the Lithium 9V ASI Battery eeeeeeeeeneeeneennene 34 XM rupe 35 LE MEDICO ARE 35 56 Obperator s Checklist enceinte rye RENE de dE ere ERR EIER Enia 36 5 7 Toubleshootirig eerie conten anne oat aa adaa iaiu riaan akene inn 37 5 8 C LIII 39 6 DDU 100 AED Accessories 5 eREEREEREERENR ENNER REENEN REENEN REN EEN REENEN ENN 41 6 1 Defibrillation Monitoring Pads esee 6 2 Battery Packs oi eene rne bue osa E ETE 6 2 1 Battery Pack Active Status Indicator 6 2 2 Active Status Indicator Batter 6 3 Data Card iivicccicciccasciisivscccecnesecivessvosuiasevdduedavavedeviasierdaveeusenedsweantenderddusassdveiauiadexess 6 4 Recycling Information 6 4 1 Recycling ASSISIANCE iuueni ire setenta etn taa inna bare kia rearea 6 4 2 LC m vs 64 3 PACKAGING 22s 6 4 4 Notice to European Union Customers essere 44 PFEBASUDSBULUCIRDMEMERICIPIDLC 45 21 QDe fibtech Data Cards error rn ent rere cere rae vore 45 72 Downloa
26. ata For details about the features and use of the application refer to the DefibView documentation 71 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 45 DAC 510E EN BF 72 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 write the contents of the internal log to the D
27. ate 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 BF gt WARNING gt CAUTION Do not attempt to recharge short circuit puncture 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
28. cations 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 DAC 510E EN BF 55 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 300 shocks or 16 hours of continuous operation Charge time 6 seconds Standby life installed in unit 7 years Active Status Indicator ASI battery 9VDC 1200 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable ASI battery standby life after installation 1 year typical new battery at 25 C 8 2 2 Standard Lithium Battery Pack Category Specification Model number DBP 1400 Main battery type 15VDC 1400 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable Capacity 125 shocks or 8 hours of continuous operation Charge Time lt 9 seconds Standby life installed in unit 5 years Active Status Indicator ASI battery 9VDC 1200 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable ASI battery standby life after installation 1 year typical new battery at 25 C 56 DAC 510E EN BF 8 3 S
29. charging process or after the AED has been charged the operator may disarm the unit by pressing the ON OFF button 24 DAC 510E EN BF 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 u
30. d 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 No modification of this equipment is allowed 9 DAC 510E EN BF 2 3 General A Federal law USA restricts this device to sale by or on the order of a physician CAUTION 10 DAC 510E EN BF 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 section Before getting started identify each component and ensure that your package is complete e DDU 100 AED Battery pack Defibtech Data e 9V lithium battery Card DDC optional Defibtech DDU 100 Semi Automatic External Defibrillator Defibrillation pad package e User Manual User Manual 11 DAC 510E EN BF 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 without DDCs
31. ding the Internal Data Log eee 46 8 Technical Specifications 2 2 2 2 c2cceeeeeeeeeee nee eee ee eaeeeeeeeeaeeeeeeeeeeeeeeeeeeeeee 47 8 1 Defibtech DDU 100 AED 47 CE BE le E 47 8 12 d ET EE 47 amp T3 TT ttti troia e EP A WR reus 48 8 14 Waveform Specifications tI ERE E HER FER REM ERR HER 48 8 15 Patient Analysis Systerm aie eere ettet nto etapa inasre npa NEERA AEREE Aia 49 8 1 5 1 Shockable Rhythm Critera eet 50 8 15 2 Patient Analysis System Performance sss 51 8 16 Clinical Summary B 8 16 4 Background eoe adeo ie edi tede E E EE E CCCII EP E GONCIUSION DE 8 1 7 Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immunity esee 53 8 2 Battery Packs esses ennt nnne nn nennen nii nn sr di sariari 8 2 1 High Capacity Lithium Battery Pack m 8 2 2 Standard Lithium Battery Pack 8 3 Self Adhesive Defibrillation Monitoring Pads eene 57 8 4 Defibtech Data Cards DDCsl ENEE 57 8 5 epuer 58 9 Glossary E 59 10 Contacts e 63 11 Warranty Information eene ec a cereo GENEE eEEE ee See ene 65 vii DAC 510E EN BF viii DAC 510E EN BF 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 Defibrillato
32. e by tearing along the dotted 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 BF If not needed for immediate use the pad package can then be stored in the pad storage
33. e 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 is experiencing Service required This indicates that the unit has detected an error which rendered it inoperable and the unit requires 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 three 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 mi
34. elf 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 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 DDC 6 Up to 6 hours of ECG data DDC 12 Up to 12 hours of ECG data Audio enabled DDCs 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 ca
35. est Unit will report status of the Self Test and shut 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 27 DAC 510E EN BF 28 DAC 510E EN BF 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 to test the basic operation of the unit The unit also performs daily weekly monthly and quarterly self tests automatically when a non depleted 9V battery is present 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 and no voltage will be present at the pads at any time Note
36. evice 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 ip gt WARNING gt WARNING 8 DAC 510E EN BF 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 during analysis can cause incorrect or 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 e
37. ference 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 22 DAC 510E EN BF 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 t
38. g shock button This indicates that the 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 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 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 during the
39. h 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 BF 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 Connecting 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 da 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
40. he patient s heart 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
41. he 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 attention 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 30 DAC 510E EN BF Maintenance Related Voic
42. hods 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 table below Biphasic Patients Monophasic Patients Number Number P Value Defibrillation Efficacy 1 shock lt 2 shocks lt 3 shocks Patients defibrillated 54 54 100 49 58 84 ROSC 41 54 76 33 61 54 Survival to Hospital Admission 33 54 61 31 61 51 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 Survival to Hospital Discharge 15 54 28 19
43. hould stop CPR The unit will enter Analyzing 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 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 contin
44. ice ASI is solid red it detected an error Run manually initiated Self Test 9V battery low Replace ASI 9V battery Turn unit on and run manually initiated Self Test it needs servicing ASI blinks red ery pack non functional Replace battery pack Electrode pads are not pre connected Connect electrode pads to unit to unit 9V battery depleted Replace ASI 9V battery ery pack not inserted Insert battery pack ASI does not blink at all ery pack non functional Replace battery pack is non functional Return unit for service Power on self test failed T Record code number and return e i y Unit needs servicing S service code xxx unit for servicing Unit self test failed o Record code number and return A Unit needs servicing a service code xxx unit for servicing Battery pack self test failed KU Record code number and replace B iut Battery pack needs servicing service code xxx with new battery pack Service required Unit needs servicing Return unit for service 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 Battery pack low voice prompt ery pack capacity is getting low replace battery pack as soon as possible Unit will still operate to treat 9V battery low or missing patients replace 9V battery as Soon as possible
45. ing 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 1 DAC 510E EN BF 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 exponential 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
46. inking 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 42 DAC 510E EN BF 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 into 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 maxim
47. ize 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 card into the unit The DDC slot is located just inside the battery pack opening For instructions on how to install and remove a DDC card see Section 3 2 Installing the Data Card of this manual To download data from the card refer to Section 72 Downloading the Internal Data Log 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 distributor Recycle in
48. ized 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 44 DAC 510E EN BF 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 professionals to review the d
49. l 3 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 47 DAC 510E EN BF 8 1 3 Defibrillator Ener Adult 150 J nominal delivered into a 50 ohm load 9y Infant child 50 J nominal delivered into a 50 ohm load Charge control Automatic by Patient Analysis System 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 f Patient Analysis System decides rhythm is no longer ee or Charge time from shock advised Charge complete indication Within 30 seconds after Charge complete if operator has not pressed SHOCK button or Automatic DISARM Nd f defibrillation pads are removed from patient or unplugged from unit f operator presses the OFF DISARM button at any time o disarm and turns off the device Manual 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 V max Vi V min Ma The waveform is adjusted to compensate for measured patient impedance Nominal phase times and energy delivered are shown in the tables that follow 48 DAC 510E EN BF Adult Patient Impedance Ohms Phase A Durati
50. led 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 nto 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 hen sliding it closed ct 12 Ky DAC 510E EN BF 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 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 Statu
51. ly 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 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 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 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 33 DAC 510E EN BF 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
52. n 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 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 41 DAC 510E EN BF 6 2 1 Battery Pack Active Status Indicator The battery pack s Active Status Indicator ASI is located on the label 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 bl
53. ncluding 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 ui 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 additional measures may be necessary such as reorienting or relocating the DDU 100 54 DAC 510E EN BF 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 tran
54. nit 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 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 25 DAC 510E EN BF Stop now Do not touch the patient This indicates that the two minute CPR period has ended and the user s
55. nt 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 poweron sound needs user attention Self Test All indicator LEDs blinking unit Run manually initiated Self Test Hardware failure e does not operate return unit for servicing 38 DAC 510E EN BF 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 39 DAC 510E EN BF 40 DAC 510E EN BF 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 These 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 whe
56. on msec Phase B Duration msec Energy Delivered Joules 25 2 8 2 8 53 50 4 1 4 1 51 75 42 4 8 52 100 9 0 6 0 51 8 0 53 8 0 46 Pediatric Patient Impedance Ohms Phase A Duration msec 8 0 Phase B Duration msec 42 Energy Delivered Joules 25 4 1 4 1 35 50 5 8 3 8 47 75 5 8 3 8 51 100 72 4 8 53 42 4 8 52 9 0 6 0 53 9 0 8 1 5 Patient Analysis System 6 0 51 The Patient Analysis System ensures that the pad patient impedance is within the proper range and analyzes the patient s ECG rhythm to determine whether a shock is required On detection of a non shockable rhythm the user is prompted to perform CPR For shockable rhythms the AED automatically charges in preparation for shock delivery The patient analysis system will detect electrical noise or artifact in the ECG signal that may interfere with accurate rhythm analysis This artifact may be caused by excessive motion to the patient or by external electrical noise When this artifact is present the AED will prompt the user to Stop motion or Stop Interference until the ECG signal is free of noise and then proceed to analysis 49 DAC 510E EN BF 8 1 5 1 Shockable Rhythm Criteria When placed on a patient meeting the indications for use criteria the DDU 100 A
57. onds Once you hear the announcement release the ON OFF button The unit will then prompt you to press flashing shock button When prompted press and release the flashing SHOCK button The unit will run a series of internal tests including charge and shock tests The manually initiated Self Test can be aborted by pressing the ON OFF button again to turn the unit off When the Self Test is complete the unit will announce its status and power off If the Self Test passes The unit will announce UNIT OK and power off The unit may then be immediately used by pressing the ON OFF button again If the Self Test fails The unit will announce the symptom The user should refer to the Troubleshooting section in Chapter 5 of this manual for appropriate action 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 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 powers off The unit may then be immediately used by pressing the ON OFF button again 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
58. ould 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 E ON OFF button Push button to turn the DDU 100 AED on Push again to disarm and turn the AED off 2 DAC 510E EN BF 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 indicate 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
59. pack with a non discharged 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 g 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
60. 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 A by reversing the process used to remove the door 4 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 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 status indicator should periodically flash green Note The unit will operate without a 9V battery installed but
61. r 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 shockable 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 Charg
62. rd 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 57 DAC 510E EN BF 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 Il Processor at 300 MHz e 32 Mbyte System Memory 100 Mbyte free space on hard disk Refer to the DefibView documentation for a complete description of the application DefibView is available for download at the Defibtech website at www defibtech com 58 DAC 510E EN BF 9 Glossary of Symbols High voltage present Caution consult accompanying documents SHOCK Button Delivers defibrillation shock to the patient when the device is ready to shock 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 Do not expose to high heat or open flame Do not incinerate Recyclable Consult operating instructions Refer to instruction manual booklet Do not damage or crush Follow proper disposal procedures Meets the requirements of the European Medical Device Directive Note XXXX rep
63. rement and the AHA recommendation2 of Specificity gt 95 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 Note Additional information available upon request 8 1 6 Clinical Summary The DDU 100 AED uses a Biphasic Truncated Exponential waveform with specifications that are substantially equivalent below The DDU 100 A 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 objective 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 Pas shocks compared with 200 to chen H et al Multicenter randomized controlled trial of 150J biphasic 360 J monophasic shocks in the resuscitation of out of hospital cardiac arrest victims Circulation 2000 102 1780 1787 51 DAC 510E EN BF 8 1 6 2 Met
64. resents the identification number of the notified body Temperature limitation 59 DAC 510E EN BF Use by yyyy mm Defibrillation proof Can withstand the effects of an externally applied defibrillation shock Internally powered with defibrillator proof BF type patient applied parts per EN 60601 1 Manufacturer Date of manufacture Do not reuse For USA users only Catalogue number Keep dry Handle with care Transportation and storage requirements See environmental requirements Authorized European Representative Does not contain latex mim 4 IP54 Dust protected Protected against water jets 60 DAC 510E EN BF Classified by TUV Rheinland of NA with respect to electric shock fire and mechanical hazard only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 M90 IEC 60601 1 and IEC 60601 2 4 Conforms to UL Standard UL 60601 1 Certified to CAN CSA Standard C22 2 No 601 1 M90 Lithium Manganese Dioxide Battery Lithium Manganese Dioxide Battery Dioxide Battery Product is not sterile 61 DAC 510E EN BF 62 DAC 510E EN BF 10 Contacts Defibtech L L C ri 741 Boston Post Road Guilford CT 06437 USA 63 DAC 510E EN BF 64 DAC 510E EN BF 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 whe
65. s 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 battery 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 latc
66. 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 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 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 pic
67. smitters 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 80 MHz to 800 MHz to 2 5 output power of outside ISM bands inside ISM bands 800 MHz GHz transmitter W d 1 16 P d 1 2JP d 1 2JP d 2 3J P 0 01 0 01 0 12 0 12 0 23 0 1 0 1 0 37 0 38 0 73 1 17 1 20 2 30 3 79 Z27 12 00 23 00 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 26 957 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 communi
68. specially 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 help 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 gt WARNING gt CAUTION gt WARNING 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 an
69. ssing 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 service and contact an authorized service center 31 DAC 510E EN BF 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 a non depleted 9V battery is present 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 To perform a manual Self Test begin with the unit powered off Press and hold the ON OFF button until the unit announces that it is performing a Self Test this should take approximately 5 seconds Once you hear the announcement release the ON OFF button The unit will prompt you to press flashing shock button When prompted press and release the flashing SHOCK button The unit will run a series of internal tes
70. that does not 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 23 DAC 510E EN BF 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 flashin
71. ther 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 eight 8 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 whichever 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
72. 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 AN 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 AN 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 devices 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 BF 2 2 2 Pads WARNING 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 d
73. ts including charge and shock tests The manually initiated Self Test can be aborted by pressing the ON OFF button again to turn the unit off When the Self Test is done the unit will announce its status and power off If the Self Test passes The unit will announce UNIT OK The unit may then be immediately used by pressing the ON OFF button again If the Self Test fails The user should refer to the Troubleshooting section in Chapter 5 of this manual 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 6 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 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 Next check to ensure that the pads package has not been torn opened or damaged Dispose of the pads if the package is open or damaged Inspect
74. ture Place the second as shown pad over the ribs on the patient s left side below the left breast also as shown 20 DAC 510E EN BF 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 p
75. ty 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 61000 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 supply lines 1 kV for input output lines Surge 1 kV line s to Not applicable IEC 61000 4 5 line s 2 kV line s to earth 53 DAC 510E EN BF 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 Power frequency magnetic fields should not be greater than levels characteristic of a typical location in a commercial or hospital environment 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 range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Portable and mobile RF communications equipment should be used no closer to any part of the DDU 100 i
76. ue performing CPR This phrase is spoken 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 26 DAC 510E EN BF 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 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 T

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