- Defibtech
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1. 4 4 1 Call for Help As soon as the AED is turned on the unit will prompt the user to call for help This indicates that the first step in a rescue should always be to contact professional emergency services If another person is available the user should direct that person to call for help and then continue the rescue without delay 4 4 2 Preparing the Patient Prepare the patient by removing any clothing from the patient s chest Wipe away moisture from the chest if necessary the defibrillation pads will stick better on dry skin If necessary shave excessive chest hair which can prevent effective patient electrode contact To ensure that electrode pads fully contact the patient s skin check that no jewelry or other objects are directly underneath where the pads will be placed 4 4 3 Opening the Pad Package Remove the pad package from the pad storage slot at the back of the AED Open the pad package by tearing along the 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 e Clean of excessive debris for example dirt if the pad was dropped e Not dried out and that the gel is sticky and will adhere to the patient e Not expired Do not use pads after the expiration date printed on the package If any of these conditions is found use a new set of pads 4 4 4 Connecting Defibrillation Pads to2. 7 of 11 e Off No Shock indicated Button is disabled pressing the button will do nothing e 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 charging process or after the AED has been charged the operator may disarm the unit by pressing the ON OFF button 4 7 No Shock Required If the DDU 100 AED ECG analysis algorithm has determined that a shock is not required it will not charge the unit and the SHOCK button will not be ena
3. 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 interference Check the pads to make sure they are adhering properly to the patient If the environment is very dry minimize movement around the patient to reduce static discharges The do not touch patient LED will flash red during this message Pausing for CPR This indicates that the user should stop attempting to resolve motion and or interference problems and assess the conditi
4. 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 DAC 510E I 02 Rev B Page 9 of 11 Continue This indicates that the user should continue 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 operat
5. 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 older than 8 years Place the pads as shown in the diagram For adults and children 8 years or older For infants and children under 8 use use adult pads Place one pad just below child infant pads Place one pad in the the patient s right collar bone as shown in the center of chest and back as shown picture Place the second pad over the ribs on the patient s left side below the left breast also as shown DAC 510E I 02 Rev B Page 4 of 11 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
6. the DDU 100 AED 6 gt 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 DAC 510E I 02 Rev B Page 3 of 11 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 4 4 5 Applying Pads to the Patient Correct pad placement is essential for effective analysis of the patient
7. Defibtech DDU 100 Semi Automatic External Defibrillator User Manual Addendum Changes to Chapter 4 Using the DDU 100 AED of the Defibtech User Manual have been made to reflect the latest version of Defibtech software V2 0 Chapter 4 has been reprinted in this Addendum with changes marked in grey Please keep this Addendum with your User Manual DAC 510E I 02 Rev B 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 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 2006 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 A CAUTION Federal law USA restricts this device to sale by or on the order of a physician DAC 510E l 02 Rev B Contents 4 Using the DDU 100 AED 0 cite ee eee teen eee eee eee ee eeeeeeeeeeeeeemeeeee
8. at accurate ECG analysis is not possible and has ceased analyzing The operator is prompted to resolve the problem see Follow DDU 100 AED Prompts section Once the problem is resolved the unit will enter analysis mode again The analyzing LED will not be illuminated during this message No shock advised This indicates that the DDU 100 AED has determined that a shock is not required The unit will not charge and the SHOCK button will not be enabled The user will be prompted to begin CPR if needed for a period of two minutes Shock advised This indicates that the DDU 100 AED has determined that a shock is recommended and the unit will begin charging in anticipation of a defibrillation shock Analysis will continue and the analyzing LED will continue to flash green 4 6 Delivering the Shock If the DDU 100 AED ECG analysis algorithm has determined that a shock is required the unit will automatically charge in preparation for shock delivery While the AED charges the unit will continue to analyze the patient s heart rhythm If the unit detects that the heart rhythm has changed to one that does 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 motio
9. available In this case the 9V battery should be immediately replaced to restore active status indication If only the 9V battery is depleted the DDU 100 AED will still be fully functional when turned on and can be used in the on state normally Off Battery pack not installed AED is defective or the 9V battery is discharged Install functional battery pack or replace the 9V battery in the battery pack Steady On green DDU 100 AED is ON and operating normally Active Status Blinking green DDU 100 AED is OFF Indicator 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 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 e ASI off or blinking The Device is OFF Press green ON OFF button to turn the device ON ON OFF ASI on green The device is ON Press green ON OFF button to turn DISARM device OFF ASI on red An error has been detected and unit will turn off automatically DAC 510E I 02 Rev B Page 2 of 11 4 4 Preparation
10. bled 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 s m 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 DAC 510E I 02 Rev B Page 8 of 11 If needed begin CPR This indicates that the user should begin CPR if needed for two minutes 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 x Seconds or Continue for 1 Minu
11. eee 1 ALAM VOM ORO o A r vn 1 4 2 Checking DDU 100 AED Status oorntnnnn nn nn nn nn nen 2 4 3 Turning on the DDU 100 AED i s zs s zo non neh o za z a n nar s kosa Dna neni neh 2 4 4 Prepa ratlori s 5 sr2020201 0201n141 nsxbudlrniiaonii ona ES ng ik inkaso lana 4 4 1 Call for Help zssraesasgnevanik ne 4 4 2 Preparing the Patient 4 4 3 Opening the Pad PACK aG Cis os secs sites sete satnecncttenend in Euin iriri 3 4 4 4 Connecting Defibrillation Pads to the DDU 100 AED eees 3 4 4 5 Applying Pads tothe Patientiscccsisciasiteaciceesinandncderedaaadeabassadeonbeans 4 4 4 6 Follow DDU 100 AED Prompt zzisazuas rizadainisn cinuzhnda saa albu ENA RE 5 4 5 Heart Rhythm Analysis otttntnnnnnnnnnnnnnn enet nt 6 4 6 Delivering the Shock s12i4s10 250502010010x201n 2u olaO nn 7 4 7 No Shock Required sx i02unz o u ank su ka m no seis coetenvececcseecedaae 8 4 8 Post Shock CPR 21 x301 n00nx ian kd dn non oni setveeseniseveewsnansddeneatececten 9 4 9 Past Use ProCedures cise cies 0 oiara k nuna naniii 10 4 10 Operational Environment otrtrnnnnnnnnnn nn nen nn nn 10 10 Conta cts isz2s210111721270051157a70021000211 201202111x2251471121buz1 uchlslnuuida isi 11 DAC 510E I 02 Rev B DAC 510E I 02 Rev B 4 Using the DDU 100 AED This chapter describes how to use the DDU 100 AED The DDU 100 AED was designed for simple opera
12. ing 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 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 e Remove DDC if installed Replace with a new DDC e Reinsert battery pack Check that the battery insertion self test passes e Connect a new pad package check to make sure the package is not expired e Hold ON OFF button down for at least five seconds to initiate a manually initiated Self Test Unit will report status of 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
13. 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 DAC 510E I 02 Rev B Page 10 of 11 10 Contacts Defibtech L L C 741 Boston Post Road Guilford CT 06437 Tel 866 333 4241 Toll free within North America 203 453 4507 Fax 203 453 6657 Emails sales defibtech com Sales reporting defibtech com Medical Device Reporting service defibtech com Service and Repair European Authorized Representative Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 CE 0197 DAC 510E l 02 Rev B Page 11 of 11 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 D498 848 6 577 102 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 6 047 212 6 075 369 6 438 415 6 441 582 DAC 510E I 02 Rev B
14. n or interference and will abort charging if those conditions are detected The user can abort at any time by pushing the ON OFF button to turn the unit off Shock related voice prompts Charging This indicates that the DDU 100 AED has determined that a shock is recommended and is charging the unit in anticipation of a defibrillation shock Analysis will continue during this phase and the analyzing LED will continue to flash green A tone will sound to indicate charging progress If the unit detects a rhythm change to a non shockable one charging will abort and the user will be prompted to begin CPR if needed for a period of two minutes Stand Clear This indicates that the DDU 100 AED is charging and that the operator and others should stand clear of the patient Analysis will continue during this phase and the analyzing LED will continue to flash green A tone will sound to indicate charging progress If the unit detects a rhythm change to a non shockable one charging will abort and the user will be prompted to begin CPR if needed for a period of two minutes Press flashing shock button This indicates that 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 DAC 510E I 02 Rev B Page
15. on of the patient The user will be prompted to begin CPR if needed for a two minute period 4 5 Heart Rhythm Analysis Once the DDU 100 AED has determined that the pads are making a good connection to the patient the AED will start the ECG rhythm analysis The unit analyzes the ECG signal and determines whether a shockable or non shockable rhythm is present While analyzing the AED will continue to monitor the pad connections and will abort analysis if it detects any pad problems It will also continue to monitor for excessive motion or interference and will abort analysis if those conditions are detected Analysis related voice prompts Analyzing heart rhythm This indicates that the DDU 100 AED is actively analyzing the patient s ECG signal The AED will continue analyzing until it has determined whether a rhythm is shockable or non shockable or analyzing is interrupted for some reason The analyzing LED will flash green during this period Do not touch the patient This indicates that the DDU 100 AED is trying to analyze the patient s 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 DAC 510E I 02 Rev B Page 6 of 11 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 th
16. 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 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 patien s bare chest as shown This indicates that the DDU 100 AED has determined that the pads are not placed on the patient Place pads on the patient following instructions on the pad package If the 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 d
17. te x Seconds This indicates that the user should continue CPR if needed for x more seconds or for 1 minute and x more seconds respectively The unit will not be monitoring the patient s ECG rhythm during this two minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue This indicates that the user should continue CPR if needed This phrase is spoken between the continue for x seconds or continue for 1 minute x seconds prompts to let the operator know that the unit is still operating normally The unit will not be monitoring the patient s ECG rhythm during this two minute CPR period The analyzing LED will remain off to indicate that background rhythm monitoring has been suspended Continue for 5 4 3 2 17 Stop CPR This indicates that the user should finish performing CPR This phrase is spoken during the last several seconds of the two minute CPR period to let the operator know that the unit is still operating normally and that the two minute period is ending Stop now Do not touch the patient This indicates that the two minute CPR period has ended and the user should stop CPR The unit will enter Analyze 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
18. tion 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 a Connect pads to AED if not yet connected Place pads on patient follow instructions on pad package Follow voice prompts Press SHOCK button if instructed by the AED 4 1 Overview Pad Active Status Connector I Z Indicator defibtech_ _ ON OFF Button SD check pads Indicator LEDs amp do not touch patient gt analyzing Shock Button Speaker DAC 510E I 02 Rev B Page 1 of 11 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 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
19. uring this message Poor pad contact to patient Press pads firmly This indicates that the pads are not making proper contact with the patient and that the impedance is out of range for proper ECG analysis and shock delivery Check that the pads are properly placed and fully adhering to the patient and that there are no air bubbles between the pads and the patient Make sure that the pads are not touching each other If the pads are not sticking due to moisture dry the patient If the pads are not sticking due to excessive hair shave or clip excessive chest hair If the prompts continue try replacing the pads with a new set The check pads LED will flash red during this message Replace pads This indicates that the pads are not making proper contact with the patient and that the impedance is out of range for proper ECG analysis and shock delivery If another set of pads is available replace the pads otherwise check that the pads are properly placed and fully adhering to the patient Make 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 DAC 510E I 02 Rev B Page 5 of 11 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
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