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Defibtech User Manual - Automated External Defibrillator

1. sesseseseeeeeneenneennne nennen 18 4 3 Turning on the DDU 100 AED eene nnne 18 4 4 Preparation rennen eres ire tee eve RED dee eva Ee e decree Yap aequa 19 4 4 1 Preparing the attente dp et dp bd ale edid ie 19 4 4 2 Opening the Pad Package 19 4 4 8 Connecting Defibrillation Pads to the DDU 100 AED sss 19 4 4 4 Applying Pads to the Patient 20 4 4 5 Follow DDU 100 AED Prompts essi seine einen innt innen nnne then nn 21 4 5 Heart Rhythm Analysis eese eee eese eene nano nan snat nna sna nna tasso narrar 22 46 Delivering the ShOck eicere de tren iint ctiain shoe aan Do aro nba daa E 23 4 7 No Shock Required sssesesessssssssseeeeeeeenn nennen nennt nennen tnnt nnn nnne 24 4 8 Post Three Shock Sequence CPR sese 25 LEWIS AIR HIT 26 4 10 Operational Environment 26 5 Maintaining and Troubleshooting the DDU 100 AED 27 5A Self Tests EE 27 5 2 Routine Maintenance eerte reiner add 28 5 2 1 Checking Active Status Indicator E 28 5 2 2 Checking the Condition of the Unit and Accessories sess 29 5 2 3 Running an Extended Seit Test 29 5 24 Replacing Pads inire E RO E 30 5 2 5 Checking Pad and Battery pack Expiration Dates sss 30 5 2 6 Checking the DDC If One Was Installed sese 31 5 3 Replacing the Lithium 9V ASI Batter
2. Shock to shock cycle time e SHOCK button flashing Charge complete indication Press Shock button voice prompt e if Patient Analysis System decides rhythm is no longer shockable or within 30 seconds after Charge complete if operator Automatic has not pressed SHOCK button or DISARM f E if defibrillation pads are removed from patient or unplugged from unit if operator presses the OFF DISARM button at any time Manual to disarm and turns off the device 8 1 4 Waveform Specifications The DDU 100 AED delivers a 150J Biphasic Truncated Exponential waveform to patients with impedances ranging from 25 to 180 ohms v V max v1 A gt B t V min MII Y The waveform is adjusted to compensate for measured patient impedance as follows Patient Impedance Phase A Duration Phase B Duration Energy Delivered Ohms msec msec Joules 25 2 83 2 83 150 Duration 5 Energy 1296 8 1 5 Patient Analysis System The DDU 100 Patient Analysis System ensures that the pad patient impedance is within the proper range and analyzes the patient s ECG rhythm to determine whether a shock is required In an initial ECG signal conditioning stage ECG data are received and digital processing is done to remove baseline wander and high frequency noise An ECG signal processing stage identifies and removes artifacts from the patient s ECG signal artifacts may arise from a variety of sou
3. x seconds This indicates that the user should continue CPR if needed for x more seconds The unit will be in monitoring mode and will continue to analyze the patient s ECG any time the signal has no motion e g CPR artifacts If a shockable rhythm is detected the unit will immediately enter Analyze mode The analyzing LED will flash to indicate that background rhythm monitoring is occurring Continue This indicates that the user should continue CPR if needed This phrase is spoken between continue for x seconds prompts to let the operator know that the unit is still operating normally If a shockable rhythm is detected the unit will immediately enter Analyze mode The analyzing LED will flash to indicate that background rhythm monitoring is occurring Do not touch the patient This indicates that the one minute CPR period has ended and the user should stop CPR The unit will enter Analyze mode and the analyzing LED will flash 4 8 Post Three Shock Sequence CPR If the DDU 100 AED has delivered three consecutive shocks the unit will require a mandatory one minute CPR period No patient ECG rhythm monitoring will be done during this period Once the one minute period is complete the AED will continue in Analyzing mode Post Shock CPR Voice Prompts Pausing for CPR This indicates that the unit is pausing for a mandatory one minute CPR period The unit will not be monitoring the patient s
4. 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 Every three shocks the AED will enter Post Shock CPR mode see below otherwise after each shock the unit will return to Analyze mode Shock cancelled This indicates that the DDU 100 AED has aborted shock mode internally discharged and gone back to Analyzing mode 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 press shock button prompt the unit will automatically cancel the shock and will go back to Analyzing mode Note The DDU 100 AED will not automatically deliver a shock the user must press the SHOCK button Note At any time during the charging process or after the AED has been charged the operator may disarm the unit by pressing the ON OFF button 4 7 No Shock Required If the DDU 100 AED ECG analysis algorithm has determined that a shock is not required it will not charge the unit and will continue analyzing in Monitoring mode The operator will be prompted to begin CPR if needed for a period of one minute Any time the operator pauses CPR the AED will auto
5. 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 Install By or 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 latch clicks If the pack does not slide all the way in it is most likely inserted upside down Once fully inserted the battery pack surface should be flush with the side of the AED To remove the battery pack push the battery eject button on the side of the AED After the battery p
6. 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 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 da 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 Insert the connector end of the defibrillation pad cable into the pads connector port on the corner of the DDU 100 AED as shown Press the pads connector in firmly until it is fully seated in the unit The pad package can then be stored in the pad storage slot in the back of the DDU 100 AED After connecting the pads connector to the unit push the pad package with the pictures on the package facing up and out rounded end first into the pad holder compartment on the back of the AED When the pad pack is fully inserted press the pad cable into the groove in the back of the unit to hold it in place
7. ECG rhythm during this required one minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended 25 26 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 one minute CPR period The do not touch patient LED will be off to indicate that it is safe to touch the patient Check airway If needed begin CPR This indicates that the user should begin CPR if needed for one minute The unit will not be monitoring the patient s ECG rhythm during this required one minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue for x seconds This indicates that the user should continue CPR if needed for x more seconds The unit will not be monitoring the patient s ECG rhythm during this required one minute CPR period The analyzing LED will not flash indicating that background rhythm monitoring has been suspended Continue This indicates that the user should continue CPR if needed This phrase is spoken between continue for 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 one minute CPR period The analyzing LED will not flash indicating that
8. User s Manual The DDU 100 AED delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly Do not discharge with defibrillation pads touching or gel surface exposed Disconnect all non defibrillator proof equipment from the patient before defibrillation to prevent electrical shock hazard and potential damage to that equipment 2 1 5 Maintenance 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 WARNING CAUTION 2 2 2 Pads WARNING 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 Use only Defibtech disposable self adhesive defibrillation monitoring pads battery packs and other accessories supplied by Defibtech or its authorized distributors Substitution of non Defibtech approved accessories may cause the device to perform improperly CAUTION Follow a
9. 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 Install By and or expiration date of the battery pack is printed on the label on the pack The battery pack should be installed by this date when the battery pack is used up the unit will indicate low battery or replace battery and will flash the Active Status Indicator red Once an accessory is past its expiration date it should be replaced immediately Follow the instructions in the Installing and Removing the Battery pack and Connecting the Pads sections to replace the part with an unexpired part Patient pads should be discarded Battery packs should be appropriately recycled 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 y battery pack eject button on the side of the unit The DDC card is loc
10. background rhythm monitoring has been suspended Do not touch the patient This indicates that the manditory one minute CPR period has ended and the user should stop CPR The unit will enter Analyze mode and the analyzing LED will flash 4 9 Post Use Procedures After the DDU 100 AED has been used on a patient the unit should be cleaned following procedures in the Cleaning section and prepared for the next use The following steps should be performed e Remove battery pack Remove DDC if installed Replace with a new DDC Reinsert battery pack Check that the battery 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 Extended Self Test Unit will report status of self test and shut off 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 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 wh
11. battery standby life after installation Typically gt 5 years Typically 1 year 8 3 Self adhesive Defibrillation Monitoring Pads Use only Defibtech Pads with your DDU 100 AED Defibtech self adhesive defibrillation monitoring pads have the following characteristics Category Specification Model number DDP 100 Intended use Disposable Adhesion Self adhesive Active gel surface area 103 cm2 each nominal Cable connector type Integrated Cable length 122 cm typical Note In 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 Model Number Details Up to 3 hours of ECG data Up to 6 hours of ECG data Up to 12 hours of ECG data Audio enabled DDCs Model Number Details DDC 20AE Up to 20 minutes of Audio and 1 hour of ECG data 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 49 50 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
12. condensing 150 to 4500 meters 500 to 15 000 feet per MIL STD 810F 500 4 Procedure II Shock Drop Abuse Tolerance MIL STD 810F 51 6 5 Procedure IV 1 meter any edge corner or surface in standby mode MIL STD 810F 514 5 Category 20 RTCA DO 160D Section 8 8 2 Cat R Zone 2 Curve G Vibration Helicopter RTCA DO 160D Section 8 Cat H Zone 2 Curves B amp R Jet Aircraft 1EC60529 class IP54 Splash Proof Dust Protected Battery pack installed EN61000 4 2 1998 Severity Level 4 Open air discharges up to 8 kV or direct contact discharges up to 6 kV EN60601 1 2 limits 1993 method EN5501 1 1998 Group 1 Level B Not to exceed 30 dB uV from 30 Hz to 230 MHz and not to exceed 37 dB uV from 230 to 1000 MHz EN60601 1 2 limits 1993 method EN61000 4 3 1998 Level 3 EMC Immunity Field strength 10V m carrier frequency range 26 MHz to 1 GHz AM modulation 80 percent index at 3 frequencies 1 5 and 20 Hz 43 44 8 1 3 Defibrillator COTO ENTE Typically lt 6 seconds with a fresh DBP 2800 battery pack and lt 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 Charge time from shock advised Typically lt 17 seconds with a fresh DBP 2800 Battery pack and lt 20 seconds with a fresh DBP 1400 battery pack including analysis time Charge time may increase at the end of battery life and at temperatures below 10 C
13. ii ta 4 1 5 Operator Training Requirements EEN 4 2 Dangers Warnings and CautiONS oonmoonnccnnccnnccnncnnncnnncnnncnnnnnnnennnnnanennnenanenanes 5 2 1 Shock Fire Hazard Explosion eeeseeseeeeee eene ener nennen conan nnn 5 2211 ZI TH THIS 5 LAR Battery pack o RE aaa 5 2 13 Usage Environment nie naa a Tue acu 6 2 1 4 Defibrillation Shock Delivery eese siis einsehen iint nnns nnne 6 E ET eem 7 2 2 Improper Device Performance AANEREN 7 2 2 1 Usage Environment oe DEP Ue Ried 7 2 2 2 Pad ise Oe RR HE E E Ee e ee e PEE ere en 7 2 2 3 Patient Analysis te itte Hr tee e NN eL ete ed echoes 8 2 2 4 Shock Delivery ED 9 2 2 5 Maintenance iden ae AR de eia 9 A A OO 9 3 Setting up the DDU 100 AED 2 cceeceeeceeeeeeeceeeeeeeeeeeeeeeeeeeeeeneeeeneeneeees 11 3 1 Overview SAA A Ad di 11 3 2 Installing the Data Cardona d nde 12 3 3 Installing the Active Status Indicator 9V Battery eee 12 3 4 Installing and Removing the Battery pack seen 13 3 5 Connecting the Pads 5 into iih cas 14 3 6 Running Manually Initiated Self Tests eeeeenne 15 3 7 Storing the DDU 100 AED eeeseeeeeeeneennenennnnnneene nennen nnns 15 4 Using the DDU 100 AED ENEE ENEE RENE EE ENEE ENER EEN EEN 17 4 1 e EE 17 4 2 Checking DDU 100 AED Status
14. on the patient following instructions on the pad package 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 the patient Check that the connector is fully inserted into the unit If the prompts continue try removing and reinserting the pads connector or try a new set of pads The check pads LED will flash red during this message Poor pad contact to patient Press pads firmly This indicates that the pads are not making proper contact with the patient and that the impedance is out of range for proper ECG analysis and shock delivery Check that the pads are properly placed and fully adhering to the patient and that there are no air bubbles between the pads and the patient Make sure that the pads are not touching each other If the pads are not sticking due to moisture dry the patient If the pads are not sticking due to excessive hair shave or clip excessive chest hair If the prompts continue try replacing the pads with a new set The check pads LED will flash red during this message Replace pads This indicates that the pads are not making proper contact with the patient and that the impedance is out of range for proper ECG analysis and shock delivery If another set of pads is available replace the pads otherwise check
15. pads also known as electrodes serve two functions e Allow the unit to read the patient s electrocardiograph ECG rhythm Deliver defibrillation energy to the patient when needed The Defibtech self adhesive defibrillation monitoring pad assembly comes in a leads out sealed package that allows the device to be stored with pads connected When the DDU 100 AED is used the operator needs only to remove the pad packaging tear open the package and turn the device on to administer care The AED has a storage area in the back of the unit that allows for storage of a single sealed pad package 6 2 Battery Packs The Defibtech AED uses a lithium battery pack The battery pack contains the main lithium battery cells an LED status indicator and a 9V lithium battery Different capacity battery packs are available Refer to the Battery Packs section for detailed information on the available packs The battery pack is inserted into the battery pack opening on the side of the AED and latches into place 37 38 The main battery is based on a lithium battery technology and provides the AED with a long shelf and standby life Battery pack status indication is provided by a blinking green status LED Status indicator power is supplied by a user replaceable 9V lithium battery 6 2 1 Battery Pack Active Status Indicator The battery pack s Active Status Indicator ASI is located on the label face of the battery pack and is u
16. storage area on the back of the unit M Defibtech Data Card DDC This optional plug in card provides enhanced storage capabilities to the DDU 100 AED Active Status Indicator ASI battery This is a 9V lithium battery that provides power to the Active Status Indicator It is inserted into a compartment in the battery pack Patient pads connector Insert into Pads Connector Port item G to connect pads to the DDU 100 AED 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 e Atleast eight years old The DDU 100 AED must be used by or on the order of a physician 1 4 Contraindications The DDU 100 AED should not be used if the patient shows any of the following signs e Conscious and or responsive Breathing e Has a detectable pulse s younger than eight years old 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 Defibrillation training as required by state province or national regulations e Defibtech DDU 100 AED Training e Any additional training as required by the authorizing physician e Thorough knowledge and understanding of the material presented in this User s Manual 2 Dangers Warnings and Cautions This chapter includes a list of danger warning and caution messages that relate to the
17. to turn the unit off Shock related voice prompts Charging This indicates that the DDU 100 AED has determined that a shock is recommended and is charging the unit in anticipation of a defibrillation shock Analysis will continue during this phase and the analyzing LED will continue to flash green A tone will sound to indicate charging progress If the unit detects a rhythm change to a non shockable one charging will abort and the unit will return to Analyzing mode 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 unit will return to Analyzing mode Press red 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 23 24 e Off No Shock indicated Button is disabled pressing the button will do nothing Flashing Red Shock is recommended The device is charged and ready to shock Button is enabled Press the button to administer shock Shock x
18. turn on the voice prompts will indicate the nature of the problem Maintenance related voice prompts Power on self test failed service code xxx indicates that the DDU 100 AED has failed the power on s elf 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 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 indicates that the DDU 100 AED has detected an internal error is non operational and needs servicing Battery pack low indicates that the battery pack capacity is low and should be replaced soon The AED will still be able to deliver at least a minimum of six defibrillation shocks the first time this message is spoken Replace battery pack 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 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 patien
19. used it is possible that only ECG i e no Audio will be logged Every time the unit is turned on a file is created on the DDC the DDC card can hold a maximum 255 files Once a card is completely filled with data or files all DDC logging will stop but selected internal ECG logging will continue 8 5 Defibtech Event Viewer The Defibtech Event Viewer is a PC based application program that allows review of ECG data and other patient and device performance parameters after an emergency event The Defibtech Event Viewer runs on Windows 98 and Windows 2000 Minimum system requirements for adequate performance are as follows o Pentium Il Processor at 300 MHz o 32 Mbyte System Memory o 100 Mbyte free space on hard disk Refer to the Defibtech Event Viewer User Manual for a complete description of the Event Viewer 9 Glossary of Symbols Meaning High voltage present Refer to operating instructions User Manual Shock Button Delivers defibrillation shock to the patient when the device is ready to shock 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 51 52 10 Contacts Defibtech L L C 753 Boston Post Road Guilford CT 06437 Phone 866 333 4241 Fax 203 453 6657 Emails sales defibtech com Sales reporting defibtech com Medical Device Reporting servi
20. 2 1 3 Usage Environment DANGER DANGER CAUTION CAUTION Possible explosion hazard if used in the presence of flammable anesthetics or concentrated oxygen The DDU 100 AED has not been evaluated or approved for use in hazardous locations as defined in the National Electric Code standard In compliance with IEC classification the DDU 100 AED is not to be used in the presence of flammable substance air mixtures Do not immerse any portion of this product in water or other fluids Do not allow fluids to enter the device Avoid spilling any fluids on this device or accessories Spilling fluids into the DDU 100 AED may damage it or present a fire or shock hazard Do not autoclave or gas sterilize the DDU 100 AED or its accessories The DDU 100 AED should be stored and used only within the range of environmental conditions specified in the technical specifications 2 1 4 Defibrillation Shock Delivery WARNING 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 WARNING WARNING Improper use can cause injury Use the DDU 100 AED only as instructed in the
21. 31 LY MAE CDI E 32 BD I ET stesecsessecncsceense ties cay dasectsctede E cacunageastsieveyardeatenanvicorteccarne 32 5 6 Operators Checklist ii iii A A NA 33 5 7 e TE E EE 34 A OOO NO 36 6 DDU 100 AED Accessories ccomomcononcnnoncncnnonennnnoncnnonnnnnnnnrnnnnnnnnnnnrnnnnnnnnenannos 37 6 1 Defibrillation Monitoring Pads esee 37 6 2 Battery Pa kE a r a eio Reo mete diran 37 6 2 1 Battery Pack Active Status Indicator essent 38 6 2 2 Active Status Indicator Batter 38 6 3 Datta Cardin EP rU E 38 7 Event Viewing eeRERE KEREN RENE REENEN nenne EE ENEE EE KEEN EEN EEN ENEE RENE 41 7 3 Defibtech Data Cards rne A A Ene vn 41 7 2 Downloading the Internal Data Log eene 42 8 Technical Specifications REENEN ENNER ENEE ENER ENEE ENEE ENEE A3 8 1 Defibtech DDU 100 AED ui id 43 SAT Physical ut ed e made 43 8 T 2 ee EE 43 98 1 3 ET 44 8 1 4 Waveform Specifications easi ie seien narran 44 8 1 5 Patient Analysis System coooconccccinconocinocnconancncnnncrnnarnnnnn nana 45 8 1 5 1 Shockable Rhythm Criteria c e enn 45 8 1 5 2 Patient Analysis System Performance 46 LN BE NTTITHTESIen Lam 46 81 6 T Background isst b t un decl 47 GR 47 A THOSUIS ccxcvassgevndussdeveacsgdumenatestedcanatsst mangas stede ieabinenetastbateediustonceits Geese 47 8 1 6 4 Conclusion i eene e Cai 47 32 Battery Packs coin iii a aa 48 8 2 1 High Capacity Lithium B
22. Defibtech DDU 100 AED and its accessories Many of these messages are repeated elsewhere in this User s Manual and on the DDU 100 AED or accessories The entire list is presented here for convenience DANGER Immediate hazards that will result in serious personal injury or death WARNING Conditions hazards or unsafe practices that may result in serious personal injury or death CAUTION Conditions hazards or unsafe practices that may result in minor personal injury damage to the DDU 100 AED or loss of data 2 1 Shock Fire Hazard Explosion 2 1 1 Electricity Hazardous electrical output This equipment is for use only by qualified DANGER personnel 2 1 2 Battery pack Follow all battery pack labeling instructions Do not install battery packs after caution the install by or expiration date Lithium battery packs are not rechargeable Any attempt to recharge a lithium WARNING battery pack may result in fire or explosion Do not immerse battery pack in water or other liquids Immersion in fluids may result in fire or explosion WARNING WARNING 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
23. Defibtech DDU 100 Semi Automatic External Defibrillator User s Manual Manual Version 1 2 Software Version 1 2 January 2003 USE ONLY IF PATIENT IS UNCONSCIOUS UNRESPONSIVE NOT BREATHING PUSH ON BUTTON ON OFF FOLLOW VOICE PROMPTS IF INSTRUCTED PUSH SHOCK BUTTON 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 information in the Defibtech AED User s Manual does not constitute any warranty as to the Defibtech AED or any related products The Limited Warranty shipped with Defibtech AED products serves as the sole and exclusive warranty provided by Defibtech L L C with respect to these products Copyright Copyright 2001 2002 2003 Defibtech L L C All rights reserved No part of this documentation may be reproduced or transmitted in any form by any means without the express written consent of Defibtech L L C O 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 keen 1 E e E TEE 1 1 2 The Defibtech DDU 100 AED see 2 EC WII m EE 4 1 4 Contiaindications centi
24. ack is partially ejected pull the battery pack out 13 14 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 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 sh
25. ated 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 NOTE A DDC is not required for the DDU 100 AED to operate Even if a DDC card is not installed basic essential information will still be recorded internally The AED will still operate properly even after a replace memory card message 5 3 Replacing the Lithium 9V ASI Battery The 9V ASI battery is located in the battery pack in the 9V battery compartment see figure To install remove the cover covering the 9V battery compartment by pushing on it sideways The cover will slide approximately a 1 4 inch and then can be detached from the battery pack Insert the 9V battery into the 9V battery compartment so that the contacts on the battery touch the contacts in the battery pack The orientation of the battery contacts is shown in a picture on the inside bottom of the 9V battery compartment Replace the 9V battery compartment door by reversing the process used to remove the d
26. atient This button is disabled at all other times C analyzing LED Light Emitting Diode This green LED flashes when the DDU 100 AED is analyzing the patient s ECG rhythm D do not touch patient LED This red LED flashes when the DDU 100 AED detects motion or other interference that prevents analysis of the signal or when the user should not be touching or moving the patient E check pads LED This red LED flashes when the DDU 100 AED detects that the pad connection to the patient is poor or pads are not applied F ON OFF button Push button to turn the DDU 100 AED on Push again to disarm and turn the AED off Pads connector port Insert Patient Pads Connector item O into this port to connect pads to DDU 100 AED Battery pack The battery pack provides a replaceable main power source for the DDU 100 AED Battery pack opening Insert the battery pack firmly into this opening until the latch clicks into place Battery pack eject button This button releases the battery pack from the DDU 100 AED To remove the battery pack push the button until the battery pack is partially ejected from the unit Active Status Indicator ASI When the unit is off this indicator blinks green to indicate the unit is fully operational and blinks red to 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
27. attery Dack sisse iis einen nnn nnn 48 8 2 2 Standard Lithium Battery pack 48 8 3 Self adhesive Defibrillation Monitoring Pads eee 49 8 4 Defibtech Data Cards DDCs EEN 49 8 5 Defibtech Event Viewer NENNEN 50 9 Glossary of Svmbols SEENEN REENEN ENEE eee eee eee ENNEN ENEE ENEE EE 51 10 Coritacts EE 53 1 Introduction to the DDU 100 Series AED This User s Manual provides information to guide trained operators in the use and maintenance of the Defibtech DDU 100 series Semi Automatic External Defibrillator AED and its accessories This chapter includes an overview of the AED a discussion of when it should and should not be used and information on required operator training 1 1 Overview The DDU 100 AED is a Semi Automatic External Defibrillator AED that is designed to be easy to use portable and battery powered It has only two user controls the ON OFF and SHOCK buttons Voice prompts and visual indicators provide a simple interface for the operator The DDU 100 AED is capable of recording event information including ECG audio data optional and SHOCK NO SHOCK recommendations When connected to a patient who is unconscious and not breathing the DDU 100 AED performs the following tasks e Prompts the operator to take necessary actions to enable analysis e Automatically analyzes the patient s ECG e Determines whether a shockable rhythm is present Charges the defibrillation capacitor a
28. bably 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 Replace 9 volt battery voice prompt Plug in pads connector voice prompt Apply pads to patient s bare chest voice prompt Poor pad contact to patient or Press pads firmly voice prompt Check pads voice prompt Stop motion voice prompt Stop interference voice prompt Analyzing interrupted voice prompt Shock cancelled voice prompt Shock not delivered voice prompt Replace memory card voice prompt Unit makes periodic beep sound All indicator LEDs blinking unit does not operate Connector not in properly ake sure pads connector is oriented correctly and fully inserted Pad connector broken Replace pads Unit s connector broken Pads not connected to patient Return unit for servicing Place pads on patient Pads not making good connection to patient Check pad connection to patient Pads or pad cable damaged Dry pads Replace pads Replace pads Partial pad connection Check that pads are placed securely on patient Pads touching Separate pads and p
29. battery compartment To install remove the cover covering the 9V battery compartment by pushing on it sideways The cover will slide and detach from the battery pack Insert the 9V battery into the 9V battery compartment so that the contacts on the battery touch the contacts in the battery pack The orientation of the battery contacts is shown in a picture on the inside bottom of the 9V battery compartment Replace the 9V battery compartment door by placing it in the almost closed position and then sliding it 2 closed 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 status indicator should flash green every five seconds 3 4 Installing and Removing the Battery pack The lithium battery pack provides power to the DDU 100 AED Before inserting the battery pack into the AED the 9V lithium battery should be installed in the battery pack itself as described in the
30. ce defibtech com Service and Repair 53
31. d 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 20 4 4 4 Applying Pads to the Patient If not needed for immediate use 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 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 Pe
32. e the unit s dependability Monthly After Each Use Action Check that Active Status Indicator is flashing green Check the condition of the unit and accessories Run Extended 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 ASI is flashing red th If the ASI is not flash replaced Follow the If it is flashing red or not flashing at all the AED needs attention Anytime the e unit will periodically emit a beep to call attention to itself ng at all the most likely cause is that the ASI 9V battery needs to be 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 f 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
33. el 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 Place the pads as shown in the diagram Place one pad just below the patient s right collar bone as shown in the picture Place the second pad over the ribs on the patient s left side below the left breast also as shown 4 4 5 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 interference the AED will guide the operator with audible and visual prompts Visual prompts consisting 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 Apply pads to patient s bare chest This indicates that the DDU 100 AED has determined that the pads are not placed on the patient Place pads
34. g a Shock This reconfirmation of ECG analysis may result in an inappropriate reversal of a Shock Advised prompt 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 WARNING 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 WARNING WARNING CAUTION 2 3 General CAUTION Periodic user initiated and automatic self tests are designed to assess the DDU 100 AED s readiness for use However no degree of testing can assure performance or detect abuse damage or a defect that occurred after the most recent test is completed Use of damaged equipment or accessories may cause the device to perform improperly and or result in injury to the patient or operator Improper maintenance can ca
35. ge 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 user replaceable 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 installed status can still be checked by turning the unit on Only a fresh 9V lithium battery should be used as a replacement Refer to the Maintenance section for more information on replacement batteries The 9V battery is installed into the battery pack in the 9V
36. ich 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 Basic Self Tests are performed every time the unit is turned on and test the basic operation of the unit The unit also performs daily weekly monthly and quarterly self tests automatically when a non discharged 9V battery is present without any intervention from the operator to check the integrity of the unit s hardware and software Manually initiated Extended Self Tests may be run to test the DDU 100 s systems including the charging and shocking functions the shock is internally dissipated i e no voltage will be present at the pads at any time To run an Extended Self Test while turning the unit on continue holding the ON OFF button down for at least five seconds The unit will run Extended Self Tests report the results and will automatically shut down If the DDU 100 AED is required for an emergency push the ON OFF button again to stop the self tests and shut the unit off and then push the button to turn the unit on in the normal operating mode again Note Each Extended Self Test uses up one shock from the battery pack 27 28 5 2 Routine Maintenance Although the DDU 100 AED is designed to be very low maintenance simple maintenance tasks must be performed b y the owner operator on a regular basis to ensur
37. ion by initials or signature 33 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 s 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 nsert battery pack Bat ery pac depleted or non Replace battery pack functional it is non ional Return unit for service ery pac Replace battery pack Unit immediately turns off it is non Return unit for service ASI is solid red Unit detected an error Run Extended Self Test 9V battery low Replace ASI 9V battery ASI blinks red it needs servicing Turn unit on and run Extended Self Tests ery pack non functional Replace battery pack 9V battery depleted Replace ASI 9V battery ery pack not inserted nsert battery pack ASI does not blink at all ery pack non functional Replace battery pack Unit is non functional Return unit for service ni Power on self test failed BS Record code number and return A d A Unit needs servicing 1 n service code xxx unit for servicing Battery pack self test failed Gi Record code number and replace S dee Battery pack needs servicing service code xxx with new battery pack Service required Unit needs servicing Return unit for service Unit will pro
38. ischarges The do not touch patient LED will flash red during this message 4 5 Heart Rhythm Analysis Once the DDU 100 AED has determined that the pads are making a good connection to the patient the AED will start the ECG rhythm analysis The unit analyzes the ECG signal and determines whether a shockable or non shockable rhythm is present While analyzing the AED will continue to monitor the pad connections and will abort analysis if it detects any pad problems It will also continue to monitor for excessive motion or interference and will abort analysis if those conditions are detected Analysis related voice prompts Analyzing heart rhythm This indicates that the DDU 100 AED is actively analyzing the patient s ECG signal The AED will continue analyzing until it has determined whether a rhythm is shockable or non shockable or analyzing is interrupted for some reason The analyzing LED will flash green during this period Do not touch the patient This indicates that the DDU 100 AED is trying to analyze the patient s 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
39. lace correctly on patient Patient motion has been detected Stop patient motion External interference has been Stop external interference detected Motion or interference detected Patient s ECG rhythm changed Stop motion or interference No action necessary Shock button not pushed within 30 seconds Low battery insufficient to charge Push shock button within 30 seconds Replace battery pack Hardware failure Run Extended Self Test return unit for servicing Bad pad to patient connection Dry pads DDC card is full Check that pads are placed securely on patient Replace pads Replace DDC card with a card that is not full DDC has failed Replace DDC card Unit has detected a condition that Turn unit on to run the power on needs user attention self test Run Extended Self Test return Hardware failure s Se unit for servicing 35 36 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 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 These
40. ll 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 2 2 3 Patient Analysis WARNING WARNING WARNING WARNING WARNING WARNING Aggressive or prolonged CPR to a patient with defibrillation pads attached can cause damage to the pads Replace the defibrillation pads if they become damaged during use CPR rates above the American Heart Association guidelines of 100 BPM beats per minute can cause incorrect or delayed diagnosis by the patient analysis system Do not place 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 defibrillation pads be placed in the anterior anterior front front position Some very low amplitude or low frequency rhythms may not be interpreted as shockable VF rhythms Also some VT rhythms may not be interpreted as shockable rhythms Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis especially if very low amplitude or low frequency rhythms are present Following Shock Advised prompts patient movement and vibration must be minimized for at least 15 seconds to allow reconfirmation of ECG analysis before deliverin
41. matically analyze the patient s heart rhythm and if required will immediately enter Heart Rhythm Analysis mode as discussed previously During this one minute period the AED will not advise the user to stop motion even if motion is present During the one minute period the AED will announce time remaining in 15 second intervals The user may pause periodically during this period to allow the unit to analyze the patient s ECG At the end of the one 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 and the unit will enter monitoring mode The analyzing LED will flash to indicate that the DDU 100 AED is continuing to monitor the patient s heart rhythm Check airway If needed begin CPR This indicates that the user should begin CPR if needed for one minute The unit will be in monitoring mode and will continue to analyze the patient s ECG any time the signal has no artifacts If a shockable rhythm is detected the unit will immediately enter Analyzing mode to confirm the patient s rhythm and will give the operator appropriate instructions The analyzing LED will flash to indicate that background rhythm monitoring is occurring Continue for
42. n Heart Association AHA Task Force on Automatic External Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 95 1677 1682 8 1 6 Clinical Summary Meets the AAMI DF39 requirement and the AHA recommendation of Specificity 9596 The DDU 100 AED uses a Biphasic Truncated Exponential waveform with specifications that are substantially equivalent to the waveform specifications of the device used in the study cited below The DDU 100 AED has not been the subject of a published clinical study Schneider T Martens PR Paschen H et al Multicenter randomized controlled trial of 150J biphasic shocks compared with 200 to 360 J monophasic shocks in the resuscitation of out of hospital cardiac arrest victims Circulation 2000 102 1780 1787 8 1 6 1 Background 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 8 1 6 2 Methods AEDs were prospectively randomized according to defibrillation waveform on a daily basis in four emergency medical services systems First responders used either the 150 J biphasic AEDs or 200 to 360 J monophasic waveform AEDs on victims where defibrillation was indicated A sequence of up to three defibrillation shocks was delivered 150J 150J 150J for the biphasic units and 200J 200J 360J for the monophasic units Defibrillation was defined as termination of VF for 5 seconds wi
43. n this case the 9V battery should be immediately replaced to restore active status indication If only the 9V battery is depleted the DDU 100 AED will still be fully functional when turned on and can be used in the on state normally Off Battery pack not installed AED is defective or the 9V battery is discharged Install functional battery pack or replace the 9V battery in the battery pack Steady On green DDU 100 AED is ON and operating Active normally Status Blinking green DDU 100 AED is OFF and ready to operate normally Blinking red DDU 100 AED is OFF and the AED or battery pack needs attention Steady On red DDU 100 AED is ON and has detected an error Indicator 4 3 Turning on the DDU 100 AED Press the ON OFF button to turn the DDU 100 AED on The unit will emit a beep and all the LEDs will light up temporarily The ON OFF button will illuminate green anytime 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 ASI off or blinking The Device is OFF Press green ON OFF button to turn the device ON ON OFF e ASI on green The device is ON Press green ON OFF DISARM button to turn device OFF e ASI on red An error has been detected and unit will turn off automatically 4 4 Preparation 4 4 1 Preparing the Patient Prepare the patient by removi
44. nd 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 AED will NOT shock a patient automatically it will only advise the operator The SHOCK button is enabled only when a shockable rhythm is detected and the device is charged and ready to shock Charging occurs automatically when the device detects a shockable rhythm The operator must press the SHOCK button to initiate defibrillation The DDU 100 AED uses two self adhesive defibrillation monitoring pads to monitor ECG signals and if necessary to deliver defibrillation energy to the patient These pads also known as electrodes are provided in a single use disposable package The DDU 100 AED determines proper pad to patient contact by monitoring the impedance between the two pads impedance varies with the electrical resistance of the patient s body Visual and audio prompts inform the operator of possible problems with patient contact Voice prompts and visual 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
45. ng 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 2 Opening the Pad Package Remove the pad package from the pad storage slot at the back of the AED Open the pad package by tearing along the 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 e Free from obvious signs of damage Clean of excessive debris for example dirt if the pad was dropped e Not dried out and that the gel is sticky and will adhere to the patient e Not expired Do not use pads after the expiration date printed on the package If any of these conditions is found use a new set of pads 4 4 3 Connecting Defibrillation Pads to the DDU 100 AED 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 da 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 nee
46. ning in the AED refer to the Installing the Data Card section A new and initialized DDC card should be used each time the AED is operated to maximize recording time A new event file is created on the DDC each time the AED is turned on and the following information is recorded DDC cards may contain a maximum of 255 event files The time the AED was turned on Other data such as ECG data time data audio data audio enabled card only event milestones such as motion detection shock advice shock delivery information When an audio enabled DDC gets low on available storage the AED will stop recording the less critical audio data to allow room for additional ECG data in an attempt to record at least one hour of ECG total recording time is limited by available space on the DDC Data from a previous event will NOT be erased If the DDC fills completely the AED will still be operable and the most critical event documentation for the current session is still recorded internally Internally recorded event information can be downloaded for external review by inserting a blank DDC into the Battery pack and following the Data Download procedure refer to the Downloading the Internal Data Log section 39 40 7 Event Viewing The Defibtech Event Viewer is a Windows based software application that reads data stored on a DDC and displays it on a personal computer The Event Viewer serves four primary functions e tenables emergenc
47. o Extended Self Test mode In this mode the DDU 100 AED will run a complete set of internal tests including charge and discharge tests When the tests are completed the unit will report its status and shut off The unit may then be immediately used by pressing the ON OFF button again The Extended Self Test can be aborted by pushing the ON OFF button to turn the unit off Note Extended Self Tests will use approximately one shock s worth of energy from the battery pack and running Extended Self Tests will reduce the usable capacity of the battery In addition every time a battery pack with a non depleted 9V battery is inserted the unit runs a battery pack Insertion Self Test to test the battery pack When the test is completed the unit reports the status of the battery pack and shuts down The unit may then be immediately used 3 7 Storing the DDU 100 AED The DDU 100 AED preferably with pads attached should be stored in environmental conditions within range of the specifications refer to the Environmental section of Technical Specifications The unit 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 15 16 4 Using the DDU 100 AED This chapter describes h
48. oapy water Ammonia based cleaners Hydrogen peroxide Isopropyl alcohol 70 percent solution Chlorine bleach 30 ml liter water 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 Ooo0 oO 5 5 Storage The DDU 100 AED should be placed in a readily accessible location in an orientation where the Active Status Indicator in the upper corner of the unit can be easily seen In general the unit should be stored in clean dry and moderate temperature conditions Make sure that the environmental conditions of the storage location are within the ranges detailed in the Environmental section 5 6 Operator s Checklist The following checklist may be used as the basis for an Operator s Checklist The table should be copied and filled out as recommend by the schedule in the Routine Maintenance section As each item is completed it should be checked off Defibtech DDU 100 Operator s Checklist Defibtech DDU 100 Serial Number Defibtech DDU 100 Location Date Check unit and accessories for damage dirt and contamination Clean or replace as necessary Check that spare battery pack and pads available Check that battery pack and pads not past expiration dates Check ASI flashing green Comments Inspect
49. oor 31 32 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 active status indication and automatic self tests will not be provided Status can still be checked by turning the unit on 5 4 Cleaning Periodically clean the DDU 100 AED of any dirt or contaminants on the case and connector socket The following are important guidelines to be adhered to when cleaning the device The Battery pack should be installed when cleaning the DDU 100 Donotimmerse the DDU 100 in fluids or allow fluids to enter the unit Use a soft cloth to wipe the case clean 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 S
50. ould 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 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 3 6 Running Manually Initiated Self Tests Although the DDU 100 AED automatically runs self tests on a daily basis if a non discharged 9V battery is installed any time any of the procedures in this chapter have been performed it is recommended that DDU 100 AED be turned ON which will cause a Power On Self Test to be run The AED will run a number of self tests to ensure the unit is operational Note that the AED can be used normally at this time If the unit is not needed it should be powered OFF a few seconds later To run an Extended Self Test as the unit is being turned on press the ON OFF button for at least five seconds until the AED enters int
51. ow to use the DDU 100 AED The DDU 100 AED was designed for simple operation allowing the operator to focus on the patient There are only two control buttons and four light emitting diode LED indicators Concise and easily understandable voice messages and prompts guide the operator through the use of the unit The following sections describe in detail how to use the DDU 100 AED The basic steps for use are Turn the DDU 100 AED ON by pressing the ON OFF button Connect pads to AED if not yet connected Place pads on patient follow instructions on pad package Follow voice prompts Press SHOCK button if instructed by the AED ooo oO 4 1 Overview Pad Active Status Connector __ Indicator ON OFF Button amp check pads Indicator LEDs amp S do not touch patient O anaiyzing Shock Button Speaker 17 18 4 2 Checking DDU 100 AED Status Once a fully functional battery 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 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 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 I
52. 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 will continue analyzing in monitoring mode Analysis will continue and the analyzing LED will continue to flash green Shock advised This indicates that the DDU 100 AED has determined that a shock is recommended and the unit will begin charging in anticipation of a defibrillation shock Analysis will continue and the analyzing LED will continue to flash green 4 6 Delivering the Shock If the DDU 100 AED ECG analysis algorithm has determined that a shock is required the unit will automatically charge in preparation for shock delivery While the AED charges the unit will continue to analyze the patient s heart rhythm If the unit detects that the heart rhythm has changed to one that does not require a shock the unit will abort the charging process and go back to analyzing the rhythm 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
53. r Specification DBP 2800 Main battery type 15VDC 2800 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable Capacity A new battery typically will provide 300 shocks or 16 hours of operating time at 25 C Charge time fresh pack Typically 6 seconds Shelf life prior to installation Typically gt 5 years Standby life after installation Typically up to 7 years note pre installation plus post installation total life of 10 years Active Status Indicator ASI battery ASI battery shelf life prior to installation 9VDC 1200 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable Typically gt 5 years ASI battery standby life after installation 8 2 2 Standard Lithium Battery pack Category Model number Typically 1 year Specification DBP 1400 Main battery type 15VDC 1400 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable Capacity A new battery typically will provide 125 shocks or 8 hours of operating time at 25 C Charge Time fresh Pack Typically 9 seconds Shelf life prior to installation Typically gt 5 years Standby life after installation Typically up to 5 years Active Status Indicator ASI Battery 9VDC 1200 mAh Lithium Manganese Dioxide Disposable recyclable non rechargeable ASI battery shelf life prior to installation ASI
54. rces including noise patient motion respiration muscular contractions and pacemakers If excessive artifacts inhibiting the DDU 100 AED Patient Analysis System from accurately determining the patient s ECG rhythm are present in the ECG signal the ECG signal processing system informs the user that interference and or motion has been detected The ECG signal processing stage also computes the ECG signal s power spectrum The ECG signal and the power spectrum data are then processed by the ECG signal analysis routines These routines perform both spectral and temporal analysis to assess the shape and character of the ECG power spectrum and to compute the patient s cardiac rate The arrhythmia detection process determines whether or not to advise shocking the patient by examining the outputs of these analyses once per second for a period of 5 to 7 seconds The arrhythmia detection process employs a number of parameters to determine if a rhythm is shockable 8 1 5 1 Shockable Rhythm Criteria When placed on a patient meeting the indications for use criteria the DDU 100 AED is designed to recommend a defibrillation shock when it detects proper pad impedance and one of the following Peak to peak amplitude at least 200 uVolts Ventricular Fibrillation LI 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 Ventricular Tach
55. rmation is recorded internally within the DDU 100 AED The information recorded is limited to The time the AED was turned on e Other data such as event milestones such as motion detection shock advice shock delivery information Eight seconds of ECG data immediately before a decision 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 e 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 DDC by waiting for the unit to turn off automatically The DDU 100 will write the contents of the internal log onto the DDC This information can then be reviewed using the Defibtech Event Viewer 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 lbs 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
56. sed to indicate battery pack status A periodically blinking green LED indicates that the battery pack status is OK and the battery pack is ready for use Absence of a blinking green LED indicates a battery pack problem or a depleted or missing 9V battery Refer to the Checking DDU 100 AED Status section for information on battery pack LED indications 6 2 2 Active Status Indicator Battery 6 3 Data Cards The Active Status Indicator ASI battery is a 9V lithium battery It provides power to the Active Status Indicator to prevent the main defibrillation battery from being depleted for non essential functions This provides a significantly longer standby life for the AED and battery pack and extends the lifetime during which the DDU 100 AED can deliver defibrillation shocks The Active Status Indicator battery is a lithium 9 volt battery DDU 100 AED is designed to optionally use Defibtech Data Cards DDC The AED will operate with or without a DDC but if a DDC is installed additional event storage capacity is available The DDU 100 AED accepts DDC cards of different capacities each designed to record an assortment of data for a given period of time For example the DDU 100 AED can record more than ten hours of ECG only or approximately one hour and forty minutes of audio and ECG data on a large DDC card Cards are available with and without audio logging enabled The DDC is inserted into a slot above the battery pack ope
57. that the pads are properly placed and fully adhering to the patient Make sure that the pads are not touching each other If the pads are not sticking due to moisture dry the patient If the pads are not sticking due to excessive hair shave or clip excessive chest hair If the prompts continue try replacing the pads with a new set The check pads LED will flash red during this message 21 22 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 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 interference Check the pads to make sure they are adhering properly to the patient If the environment is very dry minimize movement around the patient to reduce static d
58. thout 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 Defibrillation Efficacy 1 shock 2 shocks 3 shocks 52 54 9696 36 61 59 52 54 9696 39 61 6496 53 54 9896 42 61 6996 Patients defibrillated 54 54 10096 49 58 84 ROSC 41 54 7696 33 61 5496 Survival to Hospital Admission 33 54 6196 31 61 51 Survival to Hospital Discharge 15 54 2896 19 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 4 48 8 2 Battery Packs 8 2 1 High Capacity Lithium Battery pack Category Model numbe
59. ts The 9V battery should be replaced as soon as possible 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 5 2 3 Running an Extended Self Test The DDU 100 AED runs a Power On Self Test every time the unit is powered up to test the basic operation of the unit The unit also runs daily weekly and monthly automatic self tests when an operational 9V ASI battery is present The user may also run an extensive user initiated self test at any time To initiate the Extended Self Test with the unit off press and hold the ON OFF button for at least five seconds The unit will run tests for approximately 10 seconds and report its status before automatically shutting down NOTE The Extended Self Test can be aborted by pressing the ON OFF button again to turn the unit off The unit may then be immediately used to treat a patient 29 30 NOTE Every time the Extended Self Test is run the unit does an internal shock test This test reduces the capacity of the battery pack by one shock 5
60. use the DDU 100 AED not to function Maintain the DDU 100 AED only as described in this User s Manual The AED contains no user serviceable parts do not take the unit apart Federal Law USA restricts this device to sale by or on the order of a physician 10 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 DDU 100 AED Battery pack Defibtech Data e 9V lithium battery Card DDC optional Defibrillation pad package User s Manual User s Manual 11 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 A without DDCs and will still store critical event information internally Different DDC versions store different amounts of information DDCs are available in versions that store and don t store audio information Refer to the DDC technical specification for exact stora
61. waveform The device delivers 150 Joules 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 Defibrillation and AED operating power is supplied by a replaceable non rechargeable lithium battery pack that provides for long standby life and low maintenance operation Battery packs are available in several configurations optimized for use in specific applications Each pack is marked with an install by or 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 p
62. y 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 tenables a patient s primary care giver to review the emergency episode e tallows Defibtech and regulatory personnel to reconstruct a cardiac episode for review of device performance t provides maintenance personnel with additional parameter information to assist in troubleshooting a device suspected of malfunctioning The Defibtech Event Viewer 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 The DDC from an event should be transported to a medical facility with the patient allowing medical professionals to review the data For details about the features and use of the Defibtech Event Viewer refer to the Defibtech Event Viewer User Manual 7 1 Defibtech Data Cards If a DDC is installed in the unit every time the DDU 100 is turned on the following information is recorded on a new file on the card e The time the AED was turned on e Other data such as ECG data time data audio data audio enabled cards only event milestones such as motion detection shock advice shock delivery information This information can be reviewed using the Defibtech Event Viewer 41 7 2 Downloading the Internal Data Log Regardless of whether a DDC is installed in the unit select info
63. ycardia least 200 Volts including ventricular flutter and polymorphic VT LI Warning Some very low amplitude or low frequency VT rhythms may not be interpreted as shockable The DDU 100 AED is designed to recommend no shock for all other rhythms including Normal Sinus Rhythms fine Ventricular Fibrillation 200 uVolts and some slow Ventricular Tachycardias and Asystole 45 46 8 1 5 2 Patient Analysis System Performance Rhythm Class Shockable Rhythm Ventricular Fibrillation ECG Test Sample Size Algorithm Performance Performance 90 Lower Confidence Limit Specifications Meets the AAMI DF39 requirement and AHA recommendation of Sensitivity 9096 Shockable Rhythm Ventricular Tachycardia Meets the AAMI DF39 requirement and AHA recommendation of Sensitivity 7596 Non Shockable Rhythm Normal Sinus Rhythm Meets the AAMI DF39 requirement of Specificity gt 95 and the AHA recommendation of Specificity 9996 Non Shockable Rhythm Asystole Meets the AAMI DF39 requirement and the AHA recommendation of Specificity 9596 Non Shockable Rhythm All other non shockable rhythms 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 America

Defibtech User Manual - Automated External Defibrillator

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