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User Manual - us defib medical technologies

1. 5 DISCARDING THE EQUIPMENT In order to avoid contamination of the environment people or other equipment make sure you have properly disinfected and decontaminated the equipment before disposing of it according to national laws for equipment with electrical content and electronic parts In order to discard parts and accessories follow the local regulations regarding hospital waste US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Electrical and Electronic Equipment Waste Discard them separately from other objects from the establishment Consult the local regulation for waste garbage consult the European Policy 2002 96 CE AED DEFIBSTART DESCRIPTION AND ITS COMPONENTS 5 1 Introduction The Automated External Defibrillator AED DefibStart is a portable equipment biphasic and designed for application in defibrillation procedures enabling the application of electric stimulation to the heart The Biphasic Technology enables its use in any environment such as stadiums and gymnasiums bus and railway stations malls and commercial centers ports and airports hotels temples trains subways airplanes and boats ambulances and air ground rescue vehicles of the police and fire departments venues for events of any kind in addition to hospital allowing basic and advanced life support This revolutionary defibrillation technology requires less than half of t
2. 6 5 Cable Connections and 55 9 7 AED DEFIB START FEATURES defen e nives Z1 Patent Analysis Systemi AED usa vii p TET VE ranean 7 2 Entry for External Power Supply in Ambulances and Aircrafts optional accessory 7 3 Entry for Compact Flash Card COBDONS 15 7 4 Installing the AED Backup dO 8 8 1 Unpacking and Accommodating Equipment ar MET T TN i 17 SURE ISIN I TE 17 9 POWER SUPPLY BATTERY 10 ISOLATING THE PATIENT THE OPERATOR AND THE EQUIPMENT 1 19 10 1 Safety anA PEOTOCHUN 19 11 GUIDELINES 2010 AMERICAN HEART 6 19 ER NS RT T I TI T TTE CT 12 HANDLING CABLES AND ACCESSORIES accedi vU SU a EE 13 1 Semi Automatic Mode Model DEFIBSTART BB 13 2 Medical Mode Model DEFIBSTART 27 14 APPHED TECHNOLOG 30 14 1 Heart Rate Deter
3. 14 1 1 Recording 30 14 1 2 Rate Pace SOUCO EANET 222 30 14 1 3 Pace Selection Criteria TETTE T ne Se ere eee eo eee 30 14 1 4 Annotation Methods 30 14 1 5 Detector Performance Results 30 14 2 Truncated Exponential Biphasic 31 14 2 1 Variations According to the Patient Thoracic Impedance 21 MEC IBI lc MC rtr 33 16 PRECAICUONS AND SPECIAL 33 17 EQUIPMENT AND ACCESSORIES CLEANING AND DESINFECTION 33 18 STORAGE AND TRANSPORTATION cccccsssecscsecsececsscsesecsucecsecsesatsecacsuesucetsucaeeatsseatseseeees 34 Wb e SzHzcy CSI c r P 34 20 MAINTENANCE AND INSPECTION 35 PAM C ids ASPETTO TTE UESTRE A 20 1 1 EN E MENU ISSN NN EI oo 20 1 2 Preventive Inspections and Cleaning 20 1 3 36 21 REPLACING THE NON RECHARGEABLE 36 HOW IO Repla
4. 200 4 150 2007 360 5 Other settings be supplied Note In case of pediatric use the equipment automatically selects the appropriate sequence as soon as the pediatric paddles are connected 12 1 Semi Automatic Mode Model DEFIBSTART Utilization When using this mode with voice command and indicator lights the rescuer will be guided to a work of defibrillation procedures and or CPR cardiopulmonary resuscitation 1 1 Turn the equipment Press on off key After completing the initialization the information below will be displayed on the screen e Beats per minute bpm and the ECG trace of the patient e Battery and timer indicator icons As soon as the equipment is turned on the timer is automatically triggered This information is displayed through the icon 00 00 13 23 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart e Number of triggered shocks indicates how many shocks were triggered on the patient This information is displayed through the icon 0 29 Visual and Sound Instructions After turning the equipment on it runs an internal SELF TEST and starts a sequence of voice command and instructions on the display Wait for the first voice command and the following message will be displayed 00 00 13 0 READY FOR USE bem 39 Connect the electrodes on the equipment blu
5. Generally the parts of the EQUIPMENT and ACCESSORIES of the Automatic External Defibrillator Monitor AED intended to come into contact with biological tissues cells and body fluids are tested and analyzed according to the guidelines and principles of ISO 10993 1 which deals exclusively with biocompatibility testing of the applied parts A ATTENTION There is a risk of polluting the environment associated with the use of accessories and consumables at the end of their lifespan The accessories and consumables should be disposed in hospital waste according to environmental law The batteries should be returned to the manufacturer after replacing due to defect or end of lifespan US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 2 CLASSIFICATION AND SYMBOLS 2 Hazardous Electricity Voltage Continuous Electrical Current AN ATTENTION Consult accompanying documents 1 Defibrillation Proof Type Applied Part Ik Defibrillation Proof BF Type Applied Part 17 This side up indicates correct position which the box should be transported Fragile indicates that the package should be transported and handled carefully Number 5 indicates stacking up to five units overlapped Minimum and Maximum Temperature Keep it dry indicates that package should be kept on a dry location IB 50 C 4 MEDICAL Indicates that it is a medical equipment and the
6. child pediatric patients 5 4 3 Accessories Pictures Figure 3 External Adhesive Transthoracic Electrodes Figure 4 External Adhesive Transthoracic Electrodes used for defibrillation model F7959W Adult used for defibrillation model F7959P Child disposable material Pediatric disposable material 12 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Figure 5 Battery Charger non disposable accessory Figure 6 Interconnection cable with the external Figure 7 Compact Flash Card optional accessory battery permanent use accessory Exclusive 5 4 3 1 Important Notes All of the accessories should be stored on well ventilated and humidity and dust free location 4 The user should be aware to place a new pair of adhesive transthoracic electrodes after its use so that the equipment is always ready for another emergency You should verify the expiry date of the electrodes to perform a prompt and fast treatment If the electrodes are expired they should be replaced immediately 5 5 Cable Connections and Accessories 13 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart E x i Shock Electrodes TFA Battory Figure 6 Connection of the cables and accessories of the AED DefibStart 1 Connection of the external adhesive transthoracic electrodes used for defibrillation 2 C
7. quality should correspond drop in Ut for 0 5 Nr to the voltage supplied in a cycle typical commercial or Voltage drop 40 Ut hospital environment Short interruption and 60 of voltage If the AED DefibStart user fluctuation on the 9 According requires the continuous drop in Ut for 5 supplied voltage M operation even when there according to IEC is interruption power 61000 4 11 Supply the AED DEFIBSTART should 30 of voltage receive energy without interruption or with drop in Ut for 25 battery cycles 43 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart lt 5 Ut gt 95 of voltage drop in Ut for 5 seconds Magnetic field on 3 A m Magnetic field on the power the power supply supply frequency should be frequency 50 60 According at characteristic levels of a Hz according to typical location in a hospital the IEC 61000 4 8 or commercial typical Note Ut is the voltage of A C power supply before the application of the assay level Table 8 THE AED DEFIBSTART was designed to operate in any environment presented below The client or AED DefibStart user should ensure its operation in one of these environments Resistance Test Assay Level of f to ABNT IEC Accordance Electromagnetic Environment interference 60601 Level Guidance o Equipment of communication of portable and mobile RF should not be used near any part of
8. ABNT NBR Class A IEC CISPR 11 The AED DefibStart is suitable for utilization in all of Harmonic the home establishments and those directly Emissions Class A connected to the public power grid of low voltage IEC 61000 3 that supplies buildings for domestic use 2 Emissions 42 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart voltage scintillation fluctuation IEC 61000 3 3 Table 7 THE AED DEFIBSTART was designed to operate in any environment presented below The client or user of the AED DefibStart should ensure its operation in where of these environments Resistance Test ASSAY LEVET Accordance Electromagnetic ABNT NBR IEC k to interference 60601 Level Environment Guidance Dischard of 6kV per contact Floors should be made of al 8 kV by the air wood or cement and Static Electricity hould h ic til DSE according should nave ceramic tiles to According If the floor is made of com a IEC 61000 synthetic material the 4 2 relative humidity should be of at least 30 Disorders 2 kV on the power triggering supply lines electrical fast 1 kV on input transients output ines tne voltage su ied in a typical IEC 61000 4 4 ge supp commercial or hospital 1 kV differential Overvoltages environment mode 4 according to EORHERORS According the IEC 61000 4 5 mod lt 5 Ut gt 95 of voltage The supplied voltage
9. American Heart Association AHA was enhanced in the new guidelines Besides the emphasis on the high quality CPR the chain acquired another link Post cardiopulmonary arrest CPA care The first link of the chain still is the immediate recognition of the emergency situation which includes CPA and calling the Emergency Medical Service 19 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Picture 1 AHA Chain of survival in Adult ACE The links of the new Chain of Survival Adult ACE are CPA and activation of the emergency Service Early CPR with emphasis on the chest compressions 3 Fast defibrillation 4 Effective Advanced Life Support Integrated Post CPR Care na Figure 9 Reproduced from American Heart Association Highlights of the 2010 American Heart Association Guidelines for CPR and ACE Translated from the Portuguese version 2 he new guidelines encourage CPR only with chest compressions CPRSCT for the layperson who witness a sudden cardiac arrest CPRSCT is easier to be performed by untrained individuals and it can easily be instructed by phone by the Emergency Medical Service EMS attendant 3 The breathing assessment See Listen and Feel was removed from the SBV algorithm These steps are shown to be inconsistent as well as the time consuming 4 The recommended treatment sequence for a rescuer that acts alone was modified No
10. equipment to charge it again Charging time with the battery fully discharged is of approximately 2 hours 15 PRECAICUONS AND SPECIAL CARE It is recommended to keep a few auxiliary materials such as surgical scissors disposable razor blade for the removal of the chest hair and disposable gloves in case its use is necessary when there is an accident 16 EQUIPMENT AND ACCESSORIES CLEANING AND DESINFECTION 33 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart It is recommended a cleaning to be performed every other three months on the AED DefibStart and accessories following the instructions below Do not spill any type of liquid and or place needles and objects in general on equipment and or accessory Do not immerge the equipment and accessories in any type of liquid to clean it The cabinet cleaning and disinfection should be performed with a slightly moistened cloth in demineralized water and neutral liquid soap and another slightly soft and moistened cloth in demineralized water with 2 of hypochlorite Do not use Cleaning agents with abrasives organic solvents chlorine alcohol or hydrocarbon solvent In order to prevent scratches on the panel display screen display carefully wipe with dry flannel in case of dirt slightly moistened cloth in water and remove the dust or dirt particles The tags present on the equipment are important and for that should not be remo
11. introduce the new battery and carefully plug in the connectors 2 After placing the battery press the on off key of the equipment and check the voice and text message READY TO USE IMPORTANT The defibrillator batteries should be returned to US DEFIB MEDICAL TECHNOLOGIES LLC after the replacement because of defect or end of the lifespan Do not disassemble or discard in fire there is also the risk of explosion Rechargeable Battery In order to recharge the equipment battery just connect it to the battery charger When connecting the battery charger to the power grid the green led connected to the power grid lights up indicating that the charger is connected to the power grid When connecting it to the equipment the red led charging lights up indicating that the battery is being charged When completing the charge the red led charging turns off and the green led connected to the power grid will remain lit A ATTENTION The AED when it uses data card it is equipped with internal batteries model CR 2032 that may be replaced between 4 to 5 years This replacement should be performed on the factory or at the authorized TECNICAL ASSISTANCE 21 ADVERSE EFFECTS The US DEFIB MEDICAL TECHNOLOGIES LLC as the manufacturer of medical and hospital equipment asks the users to report possible defects or the occurrence of any undesirable event to ensure the quality of the equipment Therefore if there is any failure or
12. loss of battery charge when performing AUTOTESTs decreasing the battery lifespan It is recommended to replace the battery when there is intervention for monitoring and discharges Preventive Maintenance 4 Perform operating test every other 2 months IMPORTANT AED can be connected to the charger indefinitely but when its use is necessary it should be disconnected from the charger because the equipment DOES NOT operate connected to the power grid ONLY with the internal battery power supply The equipment features an interlocking system where it is not possible to turn it on while connected to the battery charger 26 APPENDIX THE MANUFACTURER GUIDELINES AND DECLARATION ELECTROMAGNETIC EMISSIONS The AED DefibStart was designed to operate in any environment presented below The client or AED DefibStart user should ensure its operation in one of these environments RF EMISSION MEASUREME ELECTROMAGNETIC ENVIRONMENT NT ACCOISDPINEE GUIDANCE CIERTO THE AED DEFIBSTART is suitable for utilization in 160D 1997 M According environmental conditions and test procedures for section 21 Aero transported Equipment category M RF Emissions THE AED DEFIBSTART uses RF energy exclusively According to Group 1 for its internal functions So its RF emission is too ABNT NBR P low and it is not likely to cause any interference in IEC CISPR 11 electronic equipment nearby RF Emissions According to
13. malfunction contact the closest Authorized TECHNICAL ASSISTANCE or directly with the Sales consultant on the phone or website below US DEFIB MEDICAL TECHNOLOGIES LLC Phone 1 305 887 7552 Fax 1 305 887 7541 www usdefib com IMPORTANT NOTE not shock with short circuited paddles because the triggering gadget may be damaged Always transport the equipment with the paddles inside its transportation bag 37 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart It is required to keep the patient totally still during the ECG analysis to avoid readings errors NOTE The pictures contained herein are illustrative only and are subject to minor modifications without prior notice 22 GENERAL TECHNICAL SPECIFICATIONS Truncated Exponential Biphasic Waveform High Impact Cabinet electrically isolated Defibrillator with degree of protection against electric shock Defibrillation Proof CF Type Applied Part Automatic system for triggering in 150 200 and 200 J on the Adult Mode according to the setting and 50 J fix on the Child Pediatric Mode according to the setting The AED PEDIATRIC MODE for pediatric use the charge is automatically limited to of the energy for adult When the PEDIATRIC PADDLE is inserted the system automatically limits the energy in proportion to the sequence of the 19 2 and Subsequent shocks respectively Suitable for a
14. may require a further reference The ongoing consultation of this manual is a prerequisite to obtain a better performance of the equipment proper operation and to provide greater safety for both the operator and for the patient This manual also contains information related to technical assistance Carefully read the warnings contained on pages 5 and 6 of this manual US VEERE Automated External Defibrillator AED Defibstart SUMMARY EE Culto etes 2 CLASSIFICATION AND 4 ACRONYMS USED THIS USER MANUAL cssscsscssesscssesecseecsecsessecsecsucsecsecsecsatsacsecsacseeeee8 5 DISCARDING THE EQUIPMENT acc arts 8 6 AED DEFIBSTART DESCRIPTION AND ITS 9 MAO e INTERES O2 e cuu a ope a eee er eee eee T s ii 10 6 3 Identifications of Parts and COMMANAS ccseccsesecsesscsecsesecsesessesecsesecsesecsesccuesesseseeseaeees 11 6 4 AED DefibStart List of Parts and Accessories eee eene nennen LL 6 4 1 Accessories Accompanying the 1 41 0 LL Oa Cee See 12 od DO 6 4 3 1 Important
15. of the precautions described in this User Manual are followed The disposable electrodes are Single Use therefore should not be re sterilized Do not use the disposable electrodes if the package is damaged Risk of burn on the patient skin when applying the defibrillation Refer to the operation instructions and the other accompanying documents 22 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 12 USE INSTRUCTIONS The DefibStart Defibrillator features 02 clinical modes Semi Automatic Mode Medical Mode According to the 2010 AHA Guideline The settings of shock with biphasic waveform trace differ depending on the manufacturer none of which were directly compared in humans concerning relative efficiency Due to these differences on the waveform settings the professionals should use energy charge recommended by the manufacturer 120 a 200J for the respective waveform If the charge recommended by the manufacturer is not known consider the defibrillation the maximum permissible charge The DEFIBSTART Defibrillators are configured with the sequence of shocks on the manufacture standard ADULT 150 150 150 joules PEDIATRIC 50 50 50 joules Optional of available Settings according to the user needs it features the following options for shock sequence 1 90 130 150 150 150 2002 150 200
16. the AED DefibStart including cables with separating distance shorter than the recommended this safe distance will be calculated from the equation applicable to the transmitter frequency Conducted Recommended Separating Distance RF _ IEC 61000 4 6 3 Vrms V1 V d 3 5 E1 VP80 MHz to 800Mhz 150 kHz to 80 Mhz According Radiated RF d 7 E1 VP 800 MHz to 2 5 Ghz IEC 61000 4 3 3 V m E1 V m where Pis the maximum nominal 80 Mhz to 2 5 Ghz According potency of the transmitter output in watts w according to the transmitter manufacturer and dis distance of the recommended separation in meters m It is recommended that the field intensity established by the RF transmitter as determined through an electromagnetic inspection on the 44 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart location is lower than the level of accordance in each range of frequency An interference may occur to the surroundings of the equipment marked with the following symbol Note 1 Jn 80 MHZ and 600 MHZ the higher frequency range is applied Note 2 7hese guidelines not be applicable all of the situations The electromagnetic propagation is affected by the absorption and reflexing of structures objects and persons The field intensities established by the fixed transmitters such as radio base stations phone wireless phones and mobile terrestri
17. 14 SELF TEST The AED DefibStart when turned off performs a SELF TEST periodically for monitoring its battery charge This monitoring has the purpose of automatically inform the AED status for the user Each 4 hours the AED DefibStart automatically turns on and checks its status When detected that the battery only has 50 of its capacity the equipment will trigger the battery alarms by emitting a luminous and sound signal beep of the alarm The frequency in which the SELF TEST is performed is altered according to the battery capacity The frequency of the SELF TEST increases insofar as the battery gradually loses charge in other words insofar as the battery level decreases the alarms become more frequent indicating that the battery needs to be replaced or charged if it is rechargeable Frequency of SELF TEST Battery Capaci Alarm Each 4 hours Over 5090 of the charge Each 2 5 minutes Below 5090 of the charge Sound and Visual Alarm each 2 5 minutes minutes minute 30 seconds 4 Below 2 of the battery charge it is not possible to turn the equipment NOTE Even with the low battery alarm the equipment is still able to perform shocks If the battery is not rechargeable from the moment in which the equipment starts to emit the low battery alarm it is advisable to get in contact with US DEFIB MEDICAL TECHNOLOGIES LLC to acquire a new battery If the battery is rechargeable just connect the charger to the
18. DVD ROM drive If the installer does not automatically start locate the Setup exe file on the CD software and double click Follow the instructions displayed on the screen After the installation is complete click on the software icon that will be displayed on the computer start menu The figure bellow shows the AED Backup Screen AED Backup File Edit Show Tools Dri an 1 Events Gen Info 0004 QUU UU Jw QUU mu os Tg i T P i E sag m WE Sell a m d dE ach ame 1 Event Status 2 Figure 7 AED Software Screen In order to view the information contained in the memory card just connect it to the computer click on the menu File Import The information will be displayed the screen with the event ECG Trace Date and Hour At the Event tab all of the occurred events will be displayed with date and hour At the General Information tab figure below The equipment data will be displayed automatically and it is possible to insert comments The patient information should be filled by the rescuer or professional who is operating the software To print the information just click on the print icon on the screen 16 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillato
19. EFIBSTART TECHNICAL SPECIFICATIONS NBR IEC 60601 1 1 2004 NBR IEC 60601 1 2 2010 NBR IEC 60601 1 4 2004 NBR IEC 60601 2 4 2005 NBR IEC 60601 2 27 1997 NBR IEC 60601 2 49 2003 MDD 93 42 EEC 2007 EN ISO 14971 2007 EN ISO 13485 2003 and other Relevant Certifications Product Certification INMETRO Degree of protection against electric AED Defibrillation Proof CF Type Applied shock Part Protection against hazardous 4 54 penetration of water Safety degree of utilization in the Equipment not suitable for use in the presence of flammable anesthetic presence of flammable mixture with air mixture O2 and N20 According to the Harmonized Technical Regulations 1 5KV Max Defibrillator Output Specifications 50A Max Continuous with intermittent charge Operation Mode Minimum Interval between triggering 30 seconds Operating Humidity Dimension 25 25 0 0 Weight 2 Operating Atmospheric Pressure soni to 1060 hPa 525 mmHg to 795 23 1 Terms Definition BF Type Equipment which provides a special degree of protection against electric shock especially in relation to admissible leakage currents and reliability of the grounding connections for protection CF Type Equipment which provides a superior degree of protection to the BF Type applied part against electric shock especially in relation to admissible leakage currents 40 US MEDICAL TECHNOLOGIES Aut
20. MED 00 01 15 A MJ Fal 21 096 Important If there is no triggering Treatment Button 30 seconds automatic internal discharge will occur and the AED will proceed with the analysis automatically 7 Non Indicated Treatment When the AED displays the message NON INDICATED TREATMENT and the patient does not breath normally the rescuer should perform the basic procedure of CPR according to the 2010 AHA Guidelines 26 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 00 01 22 zs 091 bpm 00 00 59 0 PERFORM CPR FOR 2 MIN 091 bpm NOTE The timer with the time of CPR will be displayed on the screen After 2 minutes the AED automatically restarts the additional analysis of the rhythm of ECG and guides the rescuer if the TREATMENT IS INDICATED or NON INDICATED or if it will require performing CPR for 02 minutes Uncertainty of the timer is on the order of 1 5 ms min FOR MORE INFORMATION AND CLARIFICATIONS IT 19 RECOMMENDED FOLLOW THE PROTOCOL preconized by the American Heart Association AHA Guideline 2010 12 2 Medical Mode Model DEFIBSTART Utilization When using this mode it issues voice commands and indicator lights but the assessment control and determination of shock treatment is exclusive of the medical rescuer 1 Turn the equipment Press on off key After c
21. User Manual Defibstart Automated External Defibrillator Hs is a PLACE ELECTRODES PATIENT 70 Electrodes AN 55 gt lt n Lp AX HAS LE SE Ate Ow ere Se ieee ign eee Aud c EDS ER a tig eS US MEDICAL TECHNOLOGIES Manufacturer US Defib Medical Technologies Address 7831 NW 7274 AVENUE MEDLEY MIAMI Zip Code 33166 Phone 1 305 8877552 1 305 8877541 Legal Representative Amanda Coelho Rodrigues Felix OBELIS S A DE TERVUEREN 34 BTE 44 BRUSSELS CITY BELGIUM US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart FOREWORD Congratulations on your purchase of US DEFIB MEDICAL TECHNOLOGIES LLC Equipment This product incorporates state of the art technology We are certain you will be satisfied with the AED DefibStart READ ALL INSTRUCTIONS CONTAINED IN THIS MANUAL BEFORE operating the AED DefibStart This User s Manual contains all the information required for a complete interaction with the equipment from information about the operation to the required care for better conservation of the AED DefibStart The AED should only be used by trained professionals physicians or trained rescuers to provide basic and or advanced life support When you finish reading the User Manual keep it in a protected location so that you can refer to it anytime New users
22. acturer US DEFIB MEDICAL TECHNOLOGIES LLC or in some representative Check the conservation of the equipment and its accessories if there is any irregularity on the equipment it should be shipped to the manufacturer for maintenance and in case of the accessories a new material should be acquired only from the manufacturer Perform the SELF TEST on the equipment following the instructions already described on the manual if there is any irregularity contact an authorized TECHNICAL ASSISTANCE or directly the US DEFIB MEDICAL TECHNOLOGIES LLC A ATTENTION The AED DefibStart contains no parts serviceable by the user Opening the equipment will void all warranties 20 REPLACING THE NON RECHARGEABLE BATTERY The REPLACEMENT OF THE NON RECHARGEABLE BATTERY should be performed when the equipment emits a visual and sound signal beep of low battery For more information about the alarm frequency of the status indicator consult the section SELF TEST of this manual NOTE The user should request from US DEFIB MEDICAL TECHNOLOGIES LLC the supply of a new battery due to replacement at the end of the lifespan or in case of defect 36 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 20 1 How to Replace the Battery 1 There is a compartment that contains a Philips Screwdriver at the bottom of the equipment unscrew the 04 screws and remove the battery support remove the old battery and
23. al and ECG analysis to identify shockable arrhythmias VT Ventricular Tachycardia VF Ventricular Fibrillation The AED DefibStart can be set according to the need and be supplied in the following setting AED DefibStart US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Automated External Defibrillator AED with voice and text command NOTE it is possible to include Rechargeable battery Includes US DEFIB MEDICAL TECHNOLOGIES LLC battery charger Medical Mode Software where it is possible to change the setting for the evaluation control and determination of shock treatment When enabled the decision whether the treatment will be performed or not is made exclusively by the medical rescuer Any option can be set up at criterion of the specifics needs of each client it doesn t alter the characteristics of the product purpose 5 2 Overview u LE Electrodes 1 FAN On Battery e AUTOMATED ExrERNAL DEFIBRILLATOR NE mmm Figure 1 Overview of the AED DefibStart 10 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 5 3 Identifications of Parts and Commands E ces S Avtromareo EXTERNAL DEFISRILLATOR AED O P nme 2 Figure 2 General Identification of the AED DefibStart On and Off Key Treatment Button used for triggering the shock When flashing confirms tha
24. al radios amateur radio AM and FM radio transmission and VT transmission cannot be theoretically predicted with precision In order to evaluate the electromagnetic environment due to transmitters of fixed RFS an electromagnetic inspection Is recommended on the location If the measure of the field intensity on the location in which the AED DefibStart s used exceeds the level of accordance used above the AED DefibStart should be observed to check if the operation is Normal If an abnormal performance is observed additional procedures be required such as the reorientation or repositioning of the AED DefibStart 9 Above the frequency range of 150 kHz to 80 MHZ the intensity of the field should be lower than V1 Wm Table 9 45 5 MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 27 TECHNICAL ASSISTANCE US DEFIB MEDICAL TECHNOLOGIES Permanent TECHNICAL ASSISTANCE Mr Owner The US Defib Medical Technologies LLC has a list of representatives and TECHNICAL ASSISTANCE In order to provide you a personalized service please send us the registration form This aims to update our database for the best direction of the Authorized TECHNICAL ASSISTANCE services for each region training and others For complaints questions suggestions and TECHNICAL ASSISTANCE contact the Customer Assistance Service below US DEFIB MEDICAL TECHNOLOGIES Manufacturer US Defib Medical Te
25. ce Battery ma US DEFIB Automated External Defibrillator AED Defibstart 22 ADVER E EFPELIS M LM Pd M 37 23 GENERAL TECHNICAL SPECIFICATIONS tuu e Unas Ge ccu der e CLE 38 24 AED DEFIBSTART TECHNICAL 5 5 lt 40 REE HIRE eT 40 25 TECHNICAL SPECIFICATIONS AED lt lt lt 4 4 4 41 26 BATTERY IMPORTANT NOTE 41 27 APPENDIX THE MANUFACTURER GUIDELINES AND DECLARATION ELECTROMAGNETIC EME 162 Ui LM i c EE 42 ZU TECANICALA SSE TAN a 2 EUM MEE 46 customers Stir PON sess ince sivas ird n er neve mx pM ogxdsN d dus EE VES dax 47 29 FOR FURTHER yn 47 VERTON CONTROL cemere 48 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 1 WARNINGS ATTENTION The AED DefibStart must be used by properly trained personnel in basic or advanced life Support or by personnel authorized by physicians
26. chnologies Address 7831 NW 72 AVENUE MEDLEY FL Zip Code 33166 Phone 1 305 8877552 1 305 8877541 Legal Representative Amanda Coelho Rodrigues Felix OBELIS S A TERVUEREN 34 44 BRUSSELS CITY BELGIUM A ATTENTION In special cases if deemed necessary the US Defib MEDICAL TECHNOLOGIES LLC maintains available upon agreement all the technical material such as circuit diagrams list of materials technical information lists of components instructions for Calibration and gauging or whatever is necessary so that the qualified personnel by the user may proceed repairs on the parts designated repairable by the manufacturer The authorization for maintenance should be formally expressed by the US Defib MEDICAL TECHNOLOGIES LLC 46 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Customers Registration Form US DEFIB MEDICAL TECHNOLOGIES Equipment Description Serial Number Automated External Defibrillator AED Defibstart TECHNICAL ASSISTANCE ATTENTION Mr Owner Please complete the gaps above with your data and send us via FAX so that we can register them in our system in order to maintain our contacts for questionings and TECHNICAL ASSISTANCE 28 FOR FURTHER INFORMATION For additional information please call Phone 1 305 8877552 1 305 8877541 or write to Address 7831 NW 72nd AVENUE MEDLEY FL 33166 USA or se
27. continuously without the use of the AED s internal battery For that just connect it through the linking cable with the external battery figure14 Only use linking cables with external battery supplied by US DEFIB MEDICAL TECHNOLOGIES LLC Other cables may damage the equipment 6 3 Entry for Compact Flash Card Optional It is possible to record the traces date and hour of the events occurring during the use of the AED DefibStart for that just connect the memory card where indicated figure 2 The input connector only allows the card to be connected on the correct side so it is not necessary to indicate the fitting side Each time the equipment is initialized the information approximately up to 100 hours of continuous recording will be registered In order to view the information recorded on card just disconnect it from the equipment through the handle figure 15 and connect it to the card entry of the computer or if that is not possible just use and compact flash USB adaptor to unload the data on the AED Rescue Backup Software NOTE The Compact Flash Memory Card 256MB is supplied by US DeFib Medical Technologies LLC In the event of use of another card other than the one supplied by the manufacturer the card reader will have its warranty voided 6 4 Installing the AED Backup Software 15 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Insert the software CD on the CD
28. de 50 Joules the amount of shocks will be proportionally higher Optional Intelligent battery charger with time of maximum complete charge in up to 2 hours for Lithium Polymer Batteries LI PO rechargeable 18 5 MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 9 ISOLATING THE PATIENT THE OPERATOR AND THE EQUIPMENT not use the equipment inside puddles of water nor use it near flammable agents and flammable anesthetic gases Always move away from the patient when performing the treatment Do not touch the contact surface of the adhesive paddles on the patient or in conductive material that is in contact with the patient during the ECG analysis or defibrillation If the patient s chest is wet it is recommended that the rescuer dries it before connecting the electrodes 9 1 Safety and Protection 1 Patient 4 The capacitor is charged shortly before the triggering and the charge voltage is linked to the electrodes only at the moment of the shock 2 Operator The equipment only operates with internal battery lithium polymer 3 Aircraft Low radiation level of electromagnetic fields High immunity to transient and external electromagnetic fields High mechanical resistance to vibration 10 GUIDELINES 2010 AMERICAN HEART ASSOCIATION 1 The importance of the Chain of Survival for the Emergency Cardiovascular Care ECC proposed by the
29. e and white connector and fix the paddles on the patient The next voice command and the message on the display request the rescuer to place the electrodes on the patient s chest 00 00 18 0 mra PLACE ELECTRODES ON THE PATIENT M You should open the transportation bag the Emergency Cabin of the DefibStart remove the electrodes and open its package Important Note The rescuer should open the patient s shirt for quick access to the chest check if it is dry and if it has a great amount of hair it requires trichotomy hair shaving for better contact of the electrodes with the patient s chest and fix the electrodes on the chest and on the AED Optionally the electrodes may already be pre connected to the device Pay attention to the anterolateral position of the electrodes as shown in the handling instructions on the Transportation Bag internal lid of the DefibStart the figure bellow They can according to the 2010 AHA Guidelines be used in other positions front back front left subscapular and front right subscapular with the same efficiency 24 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart STERNUM 8 1 9 Figure 11 Where to fix the Electrodes the patient s chest In adults and children older than 08 years of age children who are between 01 08 years old At this moment the ECG trace will be disp
30. erating Humidity 30 a 75 Storage Temperature 0 a 50 C Shipping and Transportation Temperature 0 a 50 C Relative Humidity 10 a 95 without condensation Operating Atmospheric Pressure 700 hPa to 1060 hPa 525 mmHg to 795 mmHg Allows the register in memory of continuous ECG and critical events optional Internal Event Memory including curve date and hour optional of approximately 256MB that corresponds to over 100 hours of continuous recording Allows through the connection or other mean communication with microcomputer for memory data visualization Allows a reading posterior of the ECG trace through of hardware and or software Text and voice messages Language Portuguese English Spanish German and others Possibility of language switch through of the software ECG with beep The ECG is monitored by the paddles during and after the shock System of patient analysis 39 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Automatic ECG evaluation system that detects QRS complexes and automatically identifies malignant arrhythmias VT VF that require defibrillation Impedance measurement for adjust of the phase 1 and 2 of the biphasic wave mentioned on the pages 28 and 29 not allowing triggering in patients with low impedance impedance with open paddles or in short circuit 20 200 Ohms Event Memory until 72 seventy and two hours 23 AED D
31. fibstart POWER SUPPLY BATTERY The AED DefibStart features two options of battery Non rechargeable battery 11 1V 2200mA Rechargeable battery 11 1V 2200mA The battery charger is supplied with the equipment Lithium Polymer Battery Pack non rechargeable lifespan of 5 years in standby new and unused battery capacity of more than 5 hours of monitoring or up to 140 shocks of 150J adult mode Lithium Polymer Battery rechargeable specific manageable charger accompanying the equipment with lifespan of approximately of 5 years in standby with capacity of 5 hours of monitoring or up to 140 shocks in 150J adult mode In order to obtain the time of monitoring or the number of charges described it is necessary the battery to be fully charged new battery fully charged a It is important to observe that the battery LI PO requires a special attention that is described below ATTENTION Do not use another battery charger other than the one recommended by US DEFIB MEDICAL TECHNOLOGIES LLC The equipment will not operate for treatment while connected to the battery charger This equipment is ready to operate only with the battery power supply Do not short circuit the battery Charge it in a ventilated location Do not completely discharge the battery Do not compress or disassemble it Battery operating temperature 0 to 60 C Risk of burn fire and explosion When you use charges with the pediatric electro
32. g replaced by the user because there are differences on the connectivity amongst manufacturers 19 1 1 Calibration It is not necessary to perform the periodic Calibration of the AED DefibStart because it is calibrated in the factory according to the parameters of the 2010 American Heart Association Guide so new calibration is not necessary 19 1 2Preventive Inspections and Cleaning For increased durability of the AED DefibStart and its accessories we recommend that the Preventive Inspections and Cleaning are performed periodically following the table below 35 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Applied Verification Preventive Inspections Quarterly Table 6 For each process make sure that the equipment is turned off and its electrodes disconnected thus avoiding the risk of shocks The tags labels on the equipment should not be removed when cleaning it This process should be performed following the criteria described on the item 18 of this manual 19 1 3 Preventive Inspections We recommend an inspection to be performed on the AED DefibStart and its accessories semiannually regardless if the equipment was used or not following the instructions below Check the expiry date of the accessories shock paddles and battery if some of these accessories are close to expire or already have expired we request that you acquire a new material only by the manuf
33. he energy required by the conventional monophasic defibrillator monitors The AED DefibStart offers the possibility to be used by laypersons after training and or under medical supervision It features simple operation with the capability of recording in Memory via Date Card of 256MB that corresponds to over 100 hours of continuous recording Optional and event memory that includes the ECG pace rhythm recording and identification of the treatment stage It presents high sensitivity and specificity in the diagnosis of shockable arrhythmias Optionally includes the recording of ambient sounds It is possible to integrate to the equipment the function of measurement of blood oxygen Saturation optional The use of the AED DefibStart increases the possibility of survival to a cardiopulmonary arrest CPA The AED DefibStart features a liquid crystal display or colored in several sizes and resolutions optional for visualization of the procedures in emergency care and for the cardiac monitoring It features a microprocessor for the analysis of the cardiac activity which time for analysis is lower than 12 seconds It is a waterproof equipment resistant to dust impact and height The AED DefibStart can be applied in adult patients and optionally in pediatric patients who are in Cardiopulmonary Arrest It features voice and text command to instruct the rescuer during the CPR sequence memorization Compact Flash and ambient sound recording option
34. its voice and text commands 13 1 1 Recording Methods The arrhythmias subject to defibrillation VT and VF are pre programmed on the equipment eliminating the need of setup by the operator resulting in significant gain on the time of treatment 13 1 2 Rate Pace Source Through the equipment Defibrillator Analyzer model QA 40M manufactured by METRON the heart rates rhythm subject to defibrillation are simulated such as VT and VF the natural rhythm in several amplitudes and frequencies 13 1 3 Pace Selection Criteria The selected rhythms are those notoriously known as classic indication for a defibrillation these being ventricular fibrillation and ventricular tachycardia 13 1 4 Annotation Methods The AED DefibStart is equipped with a electroluminescent liquid crystal display or colored in several resolutions optional where the procedures of emergency care and the ECG trace are plotted allowing the graphic register of the heart rates 13 1 5 Detector Performance Results Rhythm Classification Ventricular Tachycardia A A B Ventricular Fibrillation A A B Table 2 True Positive A Accurate classification of rhythm subject to defibrillation 30 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart True Negative B Organized rhythm or in infusion or asystole that was incorrectly classified as a rhythm subject to defibrillation False positive C It is a VT or VF associa
35. layed on the screen the timer reporting the treatment period and the patient beats per minute and the analysis will be initiated 4 Clear After fixing the electrodes the voice command and the following message will be displayed 00 00 38 0 MOVE AWAY FROMTHE PATIENT 183 bpm Important Note Make sure that the patient is totally still to avoid readings errors 59 Analysis Wait for the voice command and the message that will be displayed 00 00 51 APA hel soil 20 18 Important Note The equipment will be analyzing the patient conditions and checking whether the shock is necessary or not There are two possibilities indication or non indication for the treatment 6 Treatment Indicated If the TREATMENT IS INDICATED the following information will be provided through the voice command and the display 00 00 55 Al 00 00 38 M wd 0 A Ave SAN sil 70 TREATMENT INDICATED 1 83 183 bpm 25 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart After the INDICATION OF THE TREATMENT the following sequence of commands and voice instructions will occur 1 CLEAR 00 00 38 APA Me Ael soa 183 bpm 2 AUDIBLE SOUND Charging the Capacitor 00 01 06 ge 185 3 PRESS THE TREATMENT BUTTON Press the Button 2 PRESS TREATMENT BUTTON 185 bpm 4 TREATMENT PERFOR
36. nal Defibrillator AED Defibstart already been started by the layperson while the AED checks the rhythm In these cases you may consider 1 to 3 minutes of CPR before of the first defibrillation shock 9 The implementation programs which set accessible AED in public places were encouraged where there is a relatively high probability of witnessed CPA The AHA recommends these programs to be followed by planning training and integration with the EMS for improved efficiency 10 The post CPA care include cardiopulmonary function and infusion of the vital organs optimization after the return of spontaneous circulation transportation to a suitable hospital or ICU that features means for post CPA treatment including capacity of intervention in cases of acute coronary syndromes temperature control to improve the neurological prognosis and treatment and prevention of multiple organ dysfunction Picture Simplified adult BLS algorithm Compress forcefully Compress quickly Figure 10 Reproduced from American Heart Association Highlights of the 2010 American Heart Association Guidelines for CPR and ACE Translated from the Portuguese Version 21 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 10 1 References This text was based on the new AHA guidelines for CPR American Heart Association Highlights of the 2010 American Heart Association Guidelines for CPR and ACE Translated fr
37. nal Defibrillator AED Defibstart Presents all of accessories required for its use Adult and or pediatric electrodes Problem Recommended Action The AED does not turn on Check the Battery conditions if it is discharged or installed incorrectly The AED turns but keeps repeating the Check the electrodes connection to the AED message Place the Electrodes if the Patient has a lot of chest hair it will Patient s Chest be necessary to perform a Trichotomy hair Shaving and or change such electrodes The AED emits a beep frequently This is the SELF TEST sign that the battery is low and therefore should be recharged or replaced Table 7 NOTE If the recommended actions are not enough to correct the problem contact the TECHNICAL ASSISTANCE Authorized by US Defib Medical Technologies LLC 19 MAINTENANCE AND INSPECTION 19 1 Maintenance The corrective and or preventive maintenance of the AED DefibStart should be performed exclusively by US DEFIB MEDICAL TECHNOLOGIES LLC or with some representative where is at the client discretion the periodicity to execute this maintenance according to the table below Maintenance Frequency Indication Quarterly Advisable Semiannually Annually Mandatory Table 5 The lithium polymer battery the disposable external transthoracic electrodes should be acquired EXCLUSIVELY through the US DEFIB MEDICAL TECHNOLOGIES LLC for a low cost bein
38. nd an e mail for info usdefib com Service Hours From Monday to Friday 09 00am to 05 00pm 47 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 29 VERSION CONTROL USER MANUAL PROJECT NAME Automated External Defibrillator AED DefibStart CODENAME ENG AED200 VERSION CONTROL Date Auho Nov 05 2012 Luara Delfin 48
39. ny patient Patient thoracic impedance analysis adjusting the time duration the level of electric current of the shock increasing the efficiency on the defibrillation and decreasing the risk of damage caused to the heart Time of charge until 150J lower than 5 seconds High Speed Electronic Commutation System for biphasic energy delivery Timer seconds counter Utilization of adhesive disposable paddles 4 SELF TEST 4 Possibility to use a rechargeable or non rechargeable battery 4 Intelligent Charger for Lithium Polymer rechargeable battery optional 4 Indicator of battery charge Low Battery Alarm sound and visual Battery Status 38 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Electroluminescent Monochromatic Liquid Crystal Display or colored in several resolutions optional that displays ECG trace in real time Cardiac Frequency Any frequency reading of 10 to 300 bpm with Numerical Introduction Only enables shock if the patient is fibrillating or the patient has ventricular tachycardia Allows programming alteration of the shock protocols without the need of any complementary accessory Optional Possibility of charge of up to 360 joules optional Weight approximately 1 9 Kg with battery of lithium polymer Approximated Dimensions 295 x 225 x 155 mm Shipped Firmware AED_100_A001 Operating Temperature 10 C a 40 C Op
40. om the Portuguese Version Available on http www heart org idc aroups heart ublic wcm ecc documents downloadable ucm 317343 pdf 11 HANDLING CABLES AND ACCESSORIES 4 Before placing the equipment in contact with the patient the operator should regularly check if it is in good operating conditions Check the expiry date and the transthoracic electrodes package integrity regularly 4 Only use the accessories consumables and others listed in this manual The US DEFIB MEDICAL TECHNOLOGIES LLC does not guarantee the correct operation of the equipment with the use of unknown accessories besides the company will not take any responsibility for operating failures of the equipment or possible damage caused by them A ATTENTION Generally the EQUIPMENT Parts and Accessories of the External Automated Defibrillator Monitor AED designed to be in contact with biological tissues cells or body fluids are tested and analyzed according to the ISO 10993 1 guidelines and principles which deals exclusively with biocompatibility test of the applied parts The US Defib Medical Technologies LLC ensures that all of the permanent and disposable material in contact with the patient does not cause any type of damage or harmful physiological effect as long as the procedures described in this manual are followed it is installed in an appropriate medical location it is used with the correct accessories it is operated by trained personnel and all
41. omated External Defibrillator AED Defibstart Internally Energized Equipment It is capable of operating receiving energy from an internal electrical power supply IP54 Closed equipment with protection against splashes of water and protection against dust 24 TECHNICAL SPECIFICATIONS AED MODE Entry Impedance gt 10 Mohms Frequency Response Muscular pass low 35 Hz Gains 10 20mm mV 2020 Range of Beats Reading Tolerance pimVpp 3 Sign of Calibration 1mVpp 3 Shock Application Through multifunctional adhesive paddles Scales for Defibrillation Adult 150 Child Pediatric 502 Selection Adult Child Pediatric Automatic by the type of paddles shock Defibrillator Output Specifications 1 5KV Max Maximum Time since the beginning of 31seconds the defibrillator operation to the discharge ready on the maximum energy Exponential truncated biphasic Waveform parameters adjusted according to the patient impedance Discharge Time 25 BATTERY IMPORTANT NOTE AED DefibStart battery charger alternates the type of recharge automatically it can stay connected to the power grid 24 hours per day there is no need to turn the AED of the battery charger off When performing the testes check the battery charge through the bargraff located on the inferior right corner of the display 4 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 4 There is
42. ompleting the initialization the following information will be displayed e Beats per minute bpm and the ECG trace of the patient e Battery and timer indicator icon As soon as the equipment is turned on the timer is triggered automatically This information is displayed through the icon 00 00 13 e Number of triggered shocks indicates how many shocks were triggered on the patient This information is displayed through of the icon 20 27 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 2 Visual and Sound Instructions After turning the equipment on it runs an internal self test and starts the sequence of voice command and instructions on the display Wait for the first voice command and the message that will be displayed 00 00 13 1 NN 0 READY FOR USE bus 39 Change of USE INSTRUCTIONS The Rescuer should press the TREATMENT key for 3 seconds in order to enable the Medical Mode the identification of this status will be presented on the equipment display with the message MEDICAL USE 49 Connect the electrodes on the equipment blue and white connector and fix the paddles on the patient The next voice command and the message on the display request the rescuer to place the electrodes on the patient s chest 00 00 18 ud 70 PLACE ELECTRODES THE PATIENT You should open the transportation bag or the Emergency Cabin of the DefibStart rem
43. onnection of the battery charger optional 3 Connection for ambulance entry optional accessory 4 Connection for software update optional 6 AED DEFIBSTART FEATURES Defibrillation on the Truncated Exponential Biphasic Waveform with the charge of 150J Joules in adult mode and 50 Joules in pediatric mode It features Intelligent Safety System that limits the charge for pediatric use 14 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Automatic internal discharge after 30 seconds if there is the trigger Capability to perform up to 140 discharges in maximum load new battery fully charged Electroluminescent Liquid Crystal Display that displays the ECG trace waveform 6 1 Patient Analysis System AED Automatic ECG evaluation system that detects QRS complexes and automatically identifies malignant arrhythmias ventricular tachycardia and ventricular fibrillation that require defibrillation Synchronism with R Wave the event of presence of the QRS complex when synchronized mode Pacemaker detection It features voice command with volume and text control to instruct the rescuer during the CPR sequence 6 2 Entry for External Power Supply in Ambulances and Aircrafts optional accessory pd It is possible to use the AED DefibStart utilizing the ambulance or any vehicle or aircraft 12 VDC input the equipment operates
44. ould be followed 1 REQUEST THAT EVERYONE CLEAR FROM THE PATIENT 2 THE RESCUER SHOULD PRESS THE TREATMENT KEY TO CHARGE THE CAPACITOR AUDIBLE SOUND Charging the Capacitor 00 01 06 N Aper TET Z0 CHARGING THE CAPACITOR 185 bpm 3 AFTER THE CAPACITOR CHARGES THE TREATMENT KEY WILL KEEP BLINKING UNTILL IT IS PRESSED BY THE RESCUER SO THAT THE THERAPY IS PERFORMED Press the Button 4 TREATMENT PERFORMED 00 01 15 j wi TREATMENT PERFORMED 5 A NEW CYCLE OF NOTES IS STARTED 29 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Important If there is no triggering Treatment Button in 30 seconds an automatic internal discharge will occur and the AED begins a new cycle of information for analysis Important The Medical Mode will be active until the equipment is turned back on and starts to operate in Semi Automatic Mode FOR MORE INFORMATION AND CLARIFICATIONS IT IS RECOMMENDED TO FOLLOW THE PROTOCOL preconized by the American Heart Association 2010 Guideline 13 APPLIED TECHNOLOGY 13 1 Heart Rate Detector The AED DefibStart is prepared to recognize and indicate defibrillation to cardiac rhythms of ventricular tachycardia VT of several frequencies and widths of QRS and ventricular fibrillation VF of several amplitudes AUTOMATICALLY leaving to the operator to connect the paddles on the patient s chest and to follow
45. ove the electrodes and open its package Important Note The rescuer should open the patient s shirt for quick access to the chest check if it is dry and if it has a great amount of hair it requires trichotomy hair shaving for better contact of the electrodes with the patient s chest and fix the electrodes on the chest and on the AED Optionally the electrodes may already be pre connected to the device Pay attention to the anterolateral position of the electrodes as shown in the handling instructions on the Transportation Bag internal lid of the DefibStart the figure bellow according to the 2010 AHA Guidelines it can be used in other positions front back front left subscapular and front right subscapular with the same efficiency 28 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart STERNUM 8 1 Figure 12 Where to fix the Electrodes on the patient s chest In adults and children older than 08 years of age children who are between 01 08 years old 5 Assessment After fixing the electrodes on the patient the equipment will start providing a ECG rhythm reading that will be evaluated by the rescuer who will determine whether the therapy will be used or not Important Note Make sure that the patient is totally still to avoid readings errors After the ECG signals assessment by the rescuer and if performing the treatment is chosen the sequence below sh
46. r AED Defibstart amp AED Backup File Edit Show Tools D amp um Sen Events info 1 Equipment EquipmentID MemoryCard Starting Time MameFile Comments Patient ECG Patient ID Address LastName Cty FirstName State Gender Gender Country IN Data de Birth Date ZipCode Hight Weight PhoneNumber Patient ECG Status 17022012 1114 Figure 8 AED Software General Information Screen 7 INSTALLING THE AED DEFIBSTART 7 1 Unpacking and Accommodating the Equipment Remove the equipment from the packing box Settle it in an appropriate and easy access location 4 Install it away from other equipment that generates strong magnetic fields such as radiologic device air conditioning system and others Make sure that the installation location has an appropriate ventilation and that it is within the pressure and temperature ranges indicated in this manual item 17 7 1 1 Notes Always keep the AED DefibStart stored in its transportation bag or on Emergency Cabin thus preventing damage This equipment was designed to operate in environments non constituents of Anesthetic and Flammable Cleaning Agents Do not operate it in the presence of flammable gases 17 8 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED De
47. refore deserves a special treatment EQUIPMENT Manufacturer Representative in the European Community s 4 0120 Mark of compliance with the European Community Indicates to be comprised of raw recyclable material Electrical and Electronic Equipment Waste Discard it separately from other objects US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart 3 MEASUREMENT UNITS Symbols Unit Description mmHg hpa hz rpm bpm Hertz breaths per minute beats per minute pulse per ppm minute V Mv Voltage Volts millivolts m s mm s bps Velocity Meter per second millimeter per second beats per second liters minute Energ Joules Volume Cubic meters cubic millimeters Table 1 MEASUREMENT UNITS 4 ACRONYMS USED IN THIS USER MANUAL ACLS Advanced Cardiologic Life Support AHA American Heart Association BLS Basic Life Support ICDM Implantable Cardioverter Defibrillator Monitor AED External Automated Defibrillator Monitor ECG Electrocardiogram VF Ventricular Fibrillation INCOR Heart Institute LCD Liquid Crystal Display CPA Cardiopulmonary Arrest CPR Cardiopulmonary Resuscitation BSC Brazilian Society of Cardiology VT Ventricular Tachycardia ICU Intensive Care Unit PPM Pulse per Minute
48. t the shock is ready to be applied to the patient Display exhibits the treatment time ECG trace text command for the user according to the voice command Shock paddles connector electrodes Low Battery Indicator Transportation Handle The pictures contained herein are illustrative onlv 5 4 AED DefibStart List of Parts and Accessories 5 4 1 Accessories Accompanying the Equipment 01 Lithium Polymer Battery 01 Pair of Disposable External Electrodes Models F7959W for adult patients and F7959P for child pediatric patients 01 DVD with User Manual and date card reading software Transportation Bag intended to accommodate for transport and also safer storage of the equipment 11 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart Warranty Certificate 5 4 2 Optional Accessories Cardiopulmonary Arrest Mobile Cart Emergency Cabin to hold the equipment up on walls in places easily accessible 4 Interconnect cable for external power supply BLS Rescue Bag Contains Support First Aid Temporary Immobilization Burn and Ventilation Kits 4 Battery charger if the equipment has a rechargeable battery 4 Cleaning Kit Compact Flash 256MB Memory Card Permanent Material Replacement Lithium Polymer Battery Charger Lithium Polymer Battery Consumables Disposable External Electrodes Models F7959W for adult patients and F7959P for
49. ted with a cardiac arrest that was incorrectly classified as non subject to defibrillation False negative D Accurate classification of all of the rhythm in which a shock is not indicated 13 2 Truncated Exponential Biphasic Waveform V E AD Ohms A B PHASE 01 qPHASEO2 1550 D 520 0 d a n 520 0 10 17 20 ms Figure 13 Truncated Biphasic Waveform 13 2 1 Variations According to the Patient Thoracic Impedance IMPEDANCE A PHASE 01 B PHASE 02 25 Ohms 30 Ohms 40 Ohms 50 Ohms gt 60 Ohms Table 3 Variations According to the Patient Thoracic Impedance 31 US MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart The B phase corresponds to 2 3 of the A phase Maximum Width A B 20 ms Dead time C 0 5 ms iD zi a 5 2 gt al i kal c E CL t Om E D E 5 M Time ms Figure 14 Waveform Variation According to the Patient Impedance Capacitor Charge 1237 Volts 150 Joules EE A B A B Joules as s es Ies Capacitor Charge 1428 Volts 200 Joules Delivered Impedance 1 Phase 2 The B A B Energy in Q ms ms ms Joules Table 4 Variation of the delivered energy and of the duration of the defibrillation phases performed with Truncated Biphasic Wave 22 US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart
50. to treat emergency defibrillation in patients with cardiac arrest A ATTENTION The operator should examine the equipment and accessories conditions regular trials the correct functioning prior to use A ATTENTION The operator must have the knowledge and awareness of all side effects caused while using the defibrillator ATTENTION When installing the equipment make sure that it is in a location that has enough space for ventilation so that it is placed away from heat radiation A ATTENTION The AED DefibStart was developed for applications in defibrillation procedures enabling the application of electrical stimulation to the heart It can be used in any hospital or outside hospital environment including air or ground rescue units providing advanced life support ATTENTION o not touch the patient the bed stretcher the equipment or any accessory attached to e patient during the defibrillation SU t A ATTENTION Keep the patient away from conductive and or wet surfaces and dry his her chest if necessary before using the AED DefibStart A ATTENTION In order to prevent fire or undue shock risk avoid operating the defibrillator close to water source and or flammable products do not allow any liquid to get in touch with the cabinet A ATTENTION In order to prevent fire or undue shock risk avoid operating the defibrillator close to water source and or flammable products do not allow any liq
51. uid to get in touch with the cabinet US DEFIB MEDICAL TECHNOLOGIES Automated External Defibrillator AED Defibstart A ATTENTION The electrodes can be left on the patient for a few hours depending on the skin condition ATTENTION There is risk of electric shock if the equipment cabinet is open Every type of service or future updates of this equipment and its parts may only be performed by properly trained personnel and authorized by the US Defib Medical Technologies LLC A ATTENTION Avoid using mobile phones or any devices that captures radio frequency near the equipment The high level of electromagnetic radiation emitted by these appliances can result in a great interference impairing the normal functioning of the defibrillator jeopardizing patient safety A ATTENTION The disposable materials should not be reused even after being subjected to a process of cleaning and sterilization They should be disposed in appropriate locations according to the special procedures for hospital waste A ATTENTION If any part of the equipment needs to be replaced except the disposable material you should contact the manufacturer or authorized network to provide the material and perform its replacement when necessary If accessories from suppliers other than those indicated by the US Defib Medical Technologies LLC are used the company will not be responsible for equipment operation and may have your warranty voided A ATTENTION
52. ved when cleaning it After the use of the disposable electrodes and accessories they should be disposed in appropriate locations according to the special procedures for hospital waste 17 STORAGE AND TRANSPORTATION As soon as you acquire the equipment make sure that it does not have any sign of damage Store all of the packing materials because they can be useful in case of posterior transportation Whenever you transport the AED DefibStart use the original packaging which has the necessary protection and parts indication that should stay on top It should be kept on a dry location and stacked in a maximum of five boxes respecting the limits of the following environmental conditions o Range of Room Temperature of 0 to 50 C o Range of Relative Humidity of 10 to 95 without condensation o Range of Atmospheric Pressure of 700 hPa to 1060 hPa 525mmHg to 795 Note US DEFIB MEDICAL TECHNOLOGIES LLC does not guarantee and does not take any responsibility for any damage that occurs to the equipment that is transported or stored in other package should only be transported in its original packaging 18 TROUBLESHOOTING The User should always be checking the equipment conditions Among the items that should be observed are cabinet conditions if it is intact or presents cracks dirt The battery conditions if it is charged not 34 US DEFIB Automated Exter
53. w the recommendation is that he she starts the chest compressions before the rescue ventilation The old sequence A G C Airway Good ventilation Chest Compression agora is C A G The sequence A G C remains for the neonatal care therefore almost always the cause of CPA in newborns is asphyxia 5 There was no change on the recommendation regarding the compression ventilation ratio of 30 2 for a single rescuer of adults children and babies except newborns 6 The greater emphasis of the 2010 Guideline is the need of a high quality CPR 4 Frequency of minimum compression of 100 minute instead of approximately 100 minute the it was before 4 Minimum compression depth of 5 cm in adults Full return of the chest after each compression 4 Minimization of the interruption the chest compressions Avoid excessive ventilation 7 The new guidelines minimize the importance of checking the pulse by the trained health professionals The pulse detection can be difficult even for experienced providers especially when the arterial pressure is too low When executed the pulse checking cannot take more than 10 seconds 8 The previous recommendation to use the External Automated Defibrillator Monitor AED is in as soon as possible category in case of witnessing an extra hospital CPA was reinforced When the CPA is not witnessed the EMS team should initiate CPR if it hasn t 20 US DEFIB MEDICAL TECHNOLOGIES Automated Exter

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