Defibtech View Operating Guide
Contents
1. ENVIRONMENTAL TEMPERATURE Operating 0 to 50 C 32 to 122 F Standby 0 to 50 C 32 to 122 F RELATIVE HUMIDITY Operating Standby 5 95 non condensing ALTITUDE 500 to 15 000ft 150 to 4500m per MIL STD 810F 500 4 Procedure Il VIBRATION Ground MIL STD 810F 514 5 Category20 PHYSICAL SIZE optional Up to 30 hours of ECG and event data storage no audio option or up to 3 hours of audio audio option ECG and event storage on a removable data card Actual length of storage is dependent on card capacity Helicopter RTCA DO 160D Section 8 8 2 Cat R Zone 2 Curve G Jet Aircraft RTCA DO 160D Section 8 Cat H Zone 2 Curves B amp R SHOCK DROP ABUSE TOLERANCE MIL STD 810F 516 5 Procedure IV 48 inches 1 2 meters any edge corner or surface in standby mode CRUSH TEST 1 000 pounds 450kg 7 3 x 9 5 x 2 3 Inches 18 5 x 24 x 5 8 cm WEIGHT Less than 3 Ibs 1 4kg with battery Specifications subject to change without notice TYPE Pre connected single use non polarized disposable self adhesive electrodes with cable and connector USB PORT Event download and maintenance operations SEALING WATER RESISTANCE IEC60529 class IP55 Protected against dust and waterjets battery pack installed ESD EN61000 4 2 Open air up to 8kV or direct contact up to 6kV EMC Emission CISPR 11 Group 1 Level B and FCC Part 15 EMC Immunity IEC 61000 4 3 and IEC 61002. DDU 2300 AED is not suitable for use in the presence of a flammable anesthetic mixture e Not suitable for use in oxygen enriched atmosphere e The DDU 2300 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 2300 AED is not to be used in the presence of flammable substance air mixtures A WARNINGS Conditions hazards or unsafe practices that may result in serious personal injury or death e Improper use can cause injury Use the DDU 2300 AED only as instructed in the User Manual The DDU 2300 AED delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly e Improper maintenance can cause the DDU 2300 AED not to function Maintain the DDU 2300 AED only as described in the User Manual The AED contains no user serviceable parts do not take the unit apart Electrical Shock Hazard Dangerous high voltages and currents are present Do not open unit remove cover or back or attempt repair There are no user serviceable components in the DDU 2300 AED Refer servicing to qualified service personnel e Lithium battery packs are not rechargeable Any attempt to recharge a lithium battery pack may result in fire or explosion 16 DAC 2533EN CD WARNINGS continued e Do not immerse battery pack in water or other liquids Immersion in fluids may result in fire
3. Information Softkey Icon is present on the screen the user may press the corresponding softkey button for additional information with video instruction To exit press the softkey button again Follow instructions to perform CPR Js Continue to follow the voice and display instructions When instructed do not touch the patient If instructed press SHOCK button 11 10 For more detailed information refer to the User Manual on Defibtech User CD DAC 2533EN CD DAC 2533EN CD ACTIVE STATUS INDICATOR ASI Visually check the Active Status Indicator ASI on a daily basis The ASI should flash green If the ASI flashes red is solid red or if there is no flashing light the unit requires service Anytime the ASI flashes red the unit will also beep periodically to call attention to itself Flashing Green DDU 2300 AED is OFF and ready for use Solid Green DDU 2300 AED is ON and ready for use Flashing or Solid Red DDU 2300 AED needs immediate service Refer to the Troubleshooting section of the User Manual on Defibtech User CD or call Defibtech for service Active Status Indicator e No Flashing Light DDU 2300 AED needs immediate service Refer to the Troubleshooting section of the User Manual on Defibtech User CD or call Defibtech for service AED STATUS SCREEN The AED Status Screen is used to provide a quick overview of the DDU 2300 AED s status and to display select in
4. OR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE DEFIBTECH LLC SHALL IN NO EVENT BE LIABLE FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND INCLUDING BUT NOT LIMITED TO EXEMPLARY DAMAGES SPECIAL PUNITIVE COMMERCIAL LOSS FROM ANY CAUSE BUSINESS INTERRUPTION OF ANY NATURE LOSS OF PROFITS OR PERSONAL INJURY EVEN IF DEFIBTECH LLC HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES HOWEVER OCCASIONED WHETHER BY NEGLIGENCE OR OTHERWISE UNLESS APPLICABLE STATE LAW DOES NOT ALLOW SUCH EXCLUSION OR LIMITATION Manufacturer Defibtech LLC 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 Ec REP Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 Patents pending This product and its accessories are manufactured and sold under one or more of the following United States patents D523 393 D548 346 D551 628 This product and its accessories are manufactured and sold under license to at least one or more of the following United States patents 5 591 213 5 593 427 5 601 612 5 607 454 5 611 815 5 617 853 5 620 470 5 662 690 5 735 879 5 749 904 5 749 905 5 77
5. any excess cable behind the pads package WHICH PADS TO USE ADULT PADS CHILD INFANT PADS AAN For adults and children For infants and children under 8 years 8 years or older or over or less than 55 pounds 25kgs use child 55 pounds 25kgs use infant pads Note child infant pads can be adult pads identified by their blue connector and pads package WHEN TO REPLACE THE PADS The Defibtech defibrillation pads are intended for one time use only The pads must be replaced after each use or if the package has been damaged It is important to check the expiration date of the pads The expiration date is printed on the outside of the sealed package Do not use pads past their expiration date Discard expired pads Use only Defibtech electrode pads You may also check the status of the pads when the unit is off by pressing the center softkey button to display the AED Status Screen and enter Maintenance Mode 14 DAC 2533EN CD HOW TO INSERT AND REMOVE THE BATTERY PACK Before inserting the battery pack into the DDU 2300 AED ensure that the battery pack opening in the back of the AED is clean and clear of any foreign objects Insert the battery pack into the opening in the back of the AED Push the pack all the way in until the latch clicks The battery pack will only fit in one way If the battery pack does not fit rotate the battery pack before trying again Once fully inserted the battery pack surface should
6. be flush with the back of the AED Within moments of insertion the DDU 2300 AED will turn on and run a battery pack insertion test When the test is completed the unit will report the status of the battery pack and shut down The battery pack must be removed from the unit for more than 10 seconds for the battery pack self test to be performed automatically To remove the battery pack push the battery pack eject release latch After the battery pack is partially ejected pull the battery pack out WHEN TO REPLACE THE BATTERY PACK It is important to check the expiration date of the battery pack The expiration date is printed on the label on the battery pack The battery pack should be used before the expiration date When the battery pack is low the unit will indicate battery low or replace battery now and the Active Status Indicator will flash red The battery pack should be replaced immediately Use only Defibtech battery packs You may also check the status of the battery pack when the unit is off by pressing the center softkey button to display the AED Status Screen and enter Maintenance Mode Battery Pack Expiration Date 15 oO For more detailed information refer to the User Manual on Defibtech User CD DAC 2533EN CD A DANGERS Immediate hazards that will result in serious personal injury or death e Hazardous electrical output This equipment is for use only by qualified personnel e The
7. monthly circuitry tests BATTERY INSERTION System integrity test on battery insertion PAD PRESENCE Pads preconnected 18 tested daily DAC 2533EN CD DISPLAY High resolution color LCD VIDEO PROMPTS Full motion video On screen text prompts CPR COACHING VOICE PROMPTS Extensive voice prompts guide user through operation of the unit RESCUE PROTOCOL AHA 2005 DEFIBRILLATION MONITORING PADS MODEL SURFACE AREA Adult DDP 2001 77cm nominal each pad Child Infant DDP 2002 50cm nominal each pad EVENT DOCUMENTATION INTERNAL EVENT RECORD REMOVABLE STORAGE Supports protocol updates by the user Video and voice coaching On demand video help password protected Typical with new battery at 25 C SENSITIVITY SPECIFICITY Meets AAMI DF 80 specifications and AHA recommendations CAPACITY 125 shocks or 8 hours continuous operation STANDBY LIFE 4 years LOW BATTERY INDICATIONS Visible Audible Typical with new battery at 25 C STATUS SCREEN Unit self tests results Pads and battery information status and expiration USER INITIATED Unit and battery pack system test initiated by the user STATUS INDICATION Visual and audible indication of unit status Critical ECG segments and rescue event parameters are recorded greater than 60 minutes and can be downloaded to a removable data card PC BASED EVENT REVIEW ECG with event tag display and audio playback when available
8. or explosion e Do not let fluids get into the DDU 2300 AED Avoid spilling fluids on the AED or its accessories Spilling fluids into the DDU 2300 AED may damage it or cause a fire or shock hazard Do not sterilize the DDU 2300 AED or its accessories Use only Defibtech disposable self adhesive defibrillation 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 Do not open sealed pads package until the pads are to be used Do not touch the patient during defibrillation Defibrillation current can cause operator or bystander injury Do not allow pads to touch metal objects or equipment in contact with the patient Do not touch equipment connected to the patient during defibrillation Disconnect other electrical equipment from the patient before defibrillation Do not shock with defibrillation pads touching each other Do not shock with gel surface exposed 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 The defibrillation pads are intended for one time use only and must be discarded after use Reuse can lead to potential cross infection improper pe
9. 0 4 8 19 DAC 2533EN CD ORIGINAL END USER S LIMITED WARRANTY COVERAGE Defibtech LLC provides a limited warranty that the defibrillator and its associated accessories e g batteries and pads whether purchased concurrently with the defibrillator as part of a configuration or separately shall be substantially free from defects in material and workmanship Defibtech s limited warranty shall only extend to the original end user where the original end user purchased the items from an authorized Defibtech LLC retailer This limited warranty may not be assigned or transferred The terms of the Limited Warranty in effect as of the date of original purchase shall apply to any warranty claims LENGTH OF WARRANTY The defibrillator s limited warranty is for a period of five 5 years from the date of purchase The battery s limited warranty is for a period of four 4 years from the date of purchase but in no event shall the limited warranty period extend past the date printed on the battery Single use accessories e g the pads shall have a limited warranty up to use or for a period up to the expiration date whichever is earlier The limited warranty for all other accessories is for a period of one 1 year rom the date of purchase or to the expiration date whichever is earlier LIMITED WARRANTY LIMITATIONS This limited warranty does not cover damage of any sort resulting from but not limited to accidents improp
10. 6 166 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 21 DAC 2533EN CD
11. Defibtech DDU 2300 Semi Automatic External Defibrillator Operating Guide DAC 2533EN CD 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 For more detailed information regarding the Defibtech DDU 2300 AED please refer to the User Manual on the Defibtech User CD Limited Warranty The Limited Warranty shipped with Defibtech AED products serves as the sole and exclusive warranty provided by Defibtech LLC with respect to the products contained herein Copyright Copyright 2010 Defibtech LLC All rights reserved Copyright questions should be directed to Defibtech For contact information refer to the Contacts section of this guide Federal Law USA restricts this A device to sale by or on the order of a physician CAUTION Contents Quick Use Instructions When To Use Diagram Of Components Setting Up The AED Using The AED Checking AED Status Routine Maintenance The Electrode Pads The Battery Pack Dangers Warnings And Cautions Technical Specifications Warranty Information Contacts Click any of the section headings above to be automatically re directed to that page See page references noted throughout this guide for other in
12. downloading rescue data and upgrading software To enter Maintenance Mode press T the bottom softkey button to the right of the tool icon on the AED Status Screen For instructions on how to access the AED Status Screen see previous page To exit Maintenace Mode simply turn the unit off by pressing the ON OFF button For comprehensive information about Maintenance Mode refer to Chapter 6 of the User Manual on Defibtech User CD D For more detailed information refer to the User Manual on Defibtech User CD AED maintenance AED options gt Rescue options Help topics Turn AED off The Display Screen During Maintenance Mode 13 DAC 2533EN CD HOW TO CONNECT THE PADS Insert the connector end of the defibrillation pad cable into the pads connector socket on the top left corner of the DDU 2300 AED as shown Insert pads connector firmly until it is fully seated in the unit The connector will only fit in one way if the connector does not fit rotate the connector before trying again The connected pads package can then be stored in the pad storage slot in the back of the DDU 2300 AED After connecting the pads connector to the unit push the pads package rounded end first with the pictures on the package facing out into the pad holder compartment on the back of the AED When the pads package is fully inserted press the pad cable into the groove in the back of the unit to hold the cable in place and tuck
13. er storage improper operation alterations unauthorized service ampering abuse neglect fire flood war or acts of God Additionally this limited warranty does not cover damage of any sort to the defibrillator or its associated accessories resulting rom the use of the defibrillator with unapproved accessories or use of the accessories with unapproved medical devices The defibrillator and its associated accessories are not warranted o be compatible with any other medical device LIMITED WARRANTY VOIDED The limited warranty is immediately voided if the defibrillator or its associated accessories are serviced or repaired by any entity including persons not authorized by Defibtech LLC specified maintenance is not performed the defibrillator is used with one or more unauthorized accessories the associated accessories are used with an unauthorized defibrillator or the defibrillator or associated accessories are not used in accordance with Defibtech LLC approved instructions 20 DAC 2533EN CD EXCLUSIVE REMEDY At Defibtech LLC s sole discretion Defibtech shall have the option to repair replace or provide a credit In the event of replacement Defibtech shall have the right at its sole discretion to replace the item with a new or refurbished same or similar item Determination of a similar item shall be at the sole discretion of Defibtech In the case of replacement the replacement at a minimum shall reflect the prora
14. formation without turning the unit on in Rescue Mode With the AED off press and release the CENTER softkey button to display the AED Status Screen The AED Status Screen will be displayed for a short period of time If the unit does not turn on check to make sure a good battery pack is installed Refer to the Troubleshooting section of the User Manual on Defibtech User CD 12 DAC 2533EN CD AED status Battery status m Expires 01 2012 Pads status Adult Expires 06 2012 AED SIN 099999999 Battery S N 099999999 TH Software version V1 2 AED Status Screen Although the DDU 2300 AED is designed to be very low maintenance simple maintenance tasks must be performed by the owner operator on a regular basis to ensure the unit s dependability Check that the Active Status Indicator is flashing green Check the condition of the unit and accessories Run manually initiated self test Replace pads Check pad and battery pack expiration dates Check the DDC card if one was installed If the unit needs attention refer to the Troubleshooting section of the User Manual on Defibtech User CD or call Defibtech for service For contact information refer to the Contacts section of this guide MAINTENANCE MODE Maintenance Mode permits the user to perform maintenance related actions such as viewing unit information initiating unit self tests changing unit parameters
15. ide With the AED off press AED status and release the CENTER Battery status r softkey button Ensure Expires 01 2012 Pads status Adult that the AED Status Expires 06 2012 AED SIN safes Screen appears and that Battery S N PEE EEE EEL Software version V1 2 the AED Status is OK AED Status Screen AND When the AED is off the Active Status Indicator ASI should flash green If the ASI flashes red is solid red or if there is no flashing light the unit requires service For more information refer to page 12 of this guide e Comprehensive information about the DDU 2300 Defibtech AED is found in the User Manual on Defibtech User CD 7 J For more detailed information refer to the User Manual on Defibtech User CD DAC 2533EN CD Note Turn the unit ON and then follow When this Information Softkey Icon is present on the screen the user may press the corresponding softkey button for additional information the voice and display instructions with video instruction To exit press the softkey button again Tear open Peel pads Press ON button pads package from blue liner ADULT CHILD INFANT PATIENT PATIENT Apply pads to patient s Remove clothing from patient s chest bare chest as shown If necessary shave excessive chest hair 9 8 For more detailed information refer to the User Manual on Defibtech User CD DAC 2533EN CD DAC 2533EN CD Note When this
16. rformance of the device inadequate delivery of therapy and or injury to the patient or operator WARNINGS continued e Avoid contact between parts of the patient s body and conductive fluids such as water gel blood or saline and metal objects which may provide unwanted pathways for defibrillating current Disconnect all non defibrillator proof equipment rom the patient before defibrillation to prevent electrical shock hazard and potential damage to hat equipment Aggressive or prolonged CPR to a patient with defibrillation pads attached can cause damage to he pads Replace the defibrillation pads if they become damaged during use Possible Radio frequency RF interference from RF devices such as cellular phones and two way radios can cause improper AED operation Normally using a cell phone near the AED should not cause a problem however a distance of 2 meters 6 feet between RF devices and the DDU 2300 AED is recommended CPR during analysis can cause incorrect or delayed diagnosis by the patient analysis system 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 In patients with cardiac pacemakers the DDU 2300 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 D
17. t crush Use and store the DDU 2300 AED only within the range of environmental conditions specified in the echnical specifications If possible disconnect the DDU 2300 AED from he patient prior to use of other defibrillators Do not connect the DDU 2300 to a PC or other device using the USB port while the unit s electrodes are still connected to the patient Using non Defibtech Data Cards DDC cards may damage the unit and will void the warranty Although the DDU 2300 AED is designed for a wide variety of field use conditions rough handling beyond specifications may result in damage to the unit e Federal Law USA restricts this device to sale by or on the order of a physician 17 DAC 2533EN CD DEFIBRILLATOR TYPE ENERGY Semi Automatic Adult 150 Joules external defibrillator Child Infant 50 Joules Nominal into MODEL a DDU 2300 series pe Chron WAVEFORM CONTROLS Biphasic Truncated Lighted ON OFF button Lighted Shock button Exponential Impedance CHARGE TIME compensated Less than 4 seconds shock decision to shock PATIENT ANALYSIS SYSTEM PATIENT ANALYSIS Automatically evaluates patient impedance for proper pad contact Monitors signal quality and analyzes patent ECG for shockable non shockable rhythms BATTERY PACK MODEL DBP 2003 POWER 12V 2800 mAh TYPE Lithium Manganese Dioxide Disposable recyclable non rechargeable SELF TESTS AUTOMATIC Automatic daily weekly and
18. ted time remaining for the item based on the remaining limited warranty period In the case of a credit the credit shall be the prorated value of the item based on the lower of the original item cost of the same or similar item and the remaining limited warranty period In no event shall the limited warranty period of a replacement item extend past the limited warranty period of the item it is replacing WARRANTY SERVICE In order to obtain warranty service contact the retailer from whom the item was purchased or Defibtech LLC customer service In the event an item must be returned a Return Material Authorization RMA number is required Items returned without an RMA number will not be accepted The item shall be shipped at the original end user s expense to a destination specified by the retailer or Defibtech LLC OBLIGATIONS AND WARRANTY LIMITS THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES TO THE DEGREE PERMITTED BY APPLICABLE STATE LAW ALL OTHER EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE NO PERSON INCLUDING ANY AGENT DEALER OR REPRESENTATIVE OF DEFIBTECH LLC IS AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANTY CONCERNING THE DEFIBRILLATOR OR ITS ASSOCIATED ACCESSORIES EXCEPT TO REFER TO THIS LIMITED WARRANTY THE EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES
19. teractive links This DDU 2300 Operating Guide is to be used for quick reference For comprehensive information go to the User Manual on the Defibtech User CD 2 DAC 2533EN CD WHEN TO USE THE AED Use the AED when the patient is e Unconscious e Unresponsive e Not breathing For patients under 8 years old or less than 55 pounds 25kgs use child infant electrode pads Do not delay therapy to determine exact age or weight WHEN NOT TO USE THE AED The AED should not be used if the patient is e Conscious and or responsive e Breathing e Has a detectable pulse WHO SHOULD USE THE AED The user should have e Defibrillation training as required by local state provincial or national regulations e Any additional training as required by the authorizing physician e Thorough knowledge and understanding of the material presented in this Operating Guide and in the User Manual on Defibtech User CD O J For more detailed information refer to the User Manual on Defibtech User CD 3 DAC 2533EN CD Active Status Indicator ASI Indicates the current status of the AED Pads Connector Socket Socket for pads connector ON OFF Button Turns AED on and off Softkey Buttons Top Center Bottom Buttons used to navigate menus or select options Display Screen Displays video text prompts and information USB Port SHOCK Button Enabled disabled by software to allow
20. the user to discharge a shock to the patient Defibtech Data Card DDC Card Optional USB and Defibtech Data Card DDC Card Access Door Access to the USB connector port and Defibtech Data Card slot Speaker FRONT OF AED Defibtech DDU 2300 Semi Automatic External Defibrillator Operating Guide OPERATING GUIDE BOOKLET Quick Reference DEFIBTECH USER CD Comprehensive User Manual can be found on the CD 4 DAC 2533EN CD Unit Serial Number Battery Pack Opening Battery Pack Eject Release Latch Pad Storage Area BACK OF AED Pads Connector Defibrillation Pads Expiration Date on back of package Battery Pack Defibrillation Expiration Date Pads Battery Pack Serial Number BATTERY PACK DEFIBRILLATION PADS PACKAGE 5 O J For more detailed information refer to the User Manual on Defibtech User CD DAC 2533EN CD 6 DAC 2533EN CD The DDU 2300 AED is designed to be stored in a ready state so that few steps are required to begin using the AED Ensure that the pads package has not expired Expired pads must not be used For more information refer to page 14 of this guide Ensure that the battery pack has not expired Expired battery packs must not be used When the battery pack is installed the AED will turn on and run a battery pack test Wait for the test to complete and for the unit to turn off For more information refer to page 15 of this gu
21. uring defibrillation air pockets between the skin and defibrillation pads can cause patient skin burns To help prevent air pockets make sure self adhesive defibrillation pads completely adhere to the skin Do not use dried out or expired defibrillation pads Userinitiated and automatic self tests are designed to assess the DDU 2300 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 oO For more detailed information refer to the User Manual on Defibtech User CD WARNINGS continued e Use of damaged equipment or accessories may cause the device to perform improperly and or result in injury to the patient or operator A CAUTIONS Conditions hazards or unsafe practices that may result in minor personal injury damage to the DDU 2300 AED or loss of data e Follow all battery pack labeling instructions Do not install battery packs after the expiration date e Follow all defibrillation pad label instructions Use defibrillation pads prior to their expiration date Do not re use defibrillation pads Discard defibrillation pads after use in the event of suspected pad malfunction return pads to Defibtech for testing Recycle or dispose of lithium battery packs in accordance with federal state and or local laws To avoid fire and explosion hazard do not burn or incinerate the battery pack Do no
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