HeartSine PDU 400 User Manual
Contents
1. Placement Active area Cable length Shelflife Therapeutic shock Waveform Energy Event recording Type Memory Review Single use self contained battery Non rechargeable Lithium Manganese Dioxide LiMnO2 12V 1 4AH gt 30 shocks or 6 hours of continuous monitoring Typically 5 5 years from Date of Manufacture DoM Single use pre attached Combined ECG sensor ICG sensor Defibrillation pad Anterior lateral 120 em 3 5 ft 1m Typically 5 5 years from DoM Low tilt biphasic waveform 120 Joules non escalating Removable SD memory card 100hrs of ECG and event incident recording SD memory card connected to PC via card slot or reader Saver EVO windows based data review software Electro magnetic compatibility EMC Radiated emissions Electrostatic discharge RF immunity Magnetic field immunity Aircraft EN 60601 1 2 2 Edition 2001 CISPR11 1997 1A 1999 A2 2001 Group Class B EN61000 4 2 1995 8KV Immunity A1 1998 A2 2000 EN61000 4 3 1996 80MHz 2 5GHz 10V m A1 1998 A2 2000 EN61000 4 8 1993 3 A m A1 2000 RTCA DO 160D 1997 Section 21 Category M The PDU 400 delivers a Low Tilt biphasic waveform The waveform is HeartSine has conducted extensive research in an attempt to both increase automatically tailored for a wide range of patient impedances from 20 ohms to elficacy and decrease delivered energy In clinical trials it has been shown 230 ohms and delivers2. If possible alternate with another person The PDU 400 will only administer a shock If it is needed A voice prompt will tell you when to press the shock button to administer defibrillation therapy cg The PDU 400 should not be used on someone who is responsive when shaken or breathing normally WARNINGS AND PRECAUTIONS A P P P P F amp F gt P P PP P P P P P It is advised that the PDU 400 is used by a person trained in Cardio Pulmonary Resuscitation Defibrillation CPR D The HeartSine PDU 400 has the capability to deliver therapeutic electrical shocks The electrical shock can cause serious harm to either operators or bystanders Caution must be taken to ensure that neither the operators nor bystanders touch the patient when a shock is to be delivered To safeguard against interference you must operate the PDU 400 2 meters 6 feet away from all Radio Frequency devices and other susceptible equipment Alternatively switch off equipment affected by or causing electromagnetic interference The PDU 400 has been designed to work on unconscious non responding patients If the patient is responsive or conscious do not use the PDU 400 to provide treatment Touching the patient during the analysis phase of treatment can cause interference with the diagnostic process Avoid contact with the patient while analysis is being carried out The device will instruct you when itis safe to touch the patient It has been determ
3. an optimized impedance compensated waveform at that using a low tilt waveform increases the efficacy of the therapeutic shock and allows a reduction of delivered energy from over 150 Joules to 120 a fixed energy of 120 Joules Delivered Energy 120 Joules 10 Peak Voltage 1190 Volts 8 1 phase duration 3 12 5mSecs phase duration Equal to db phase duration Inter phase duration 0 4 mSecs Fibrillation to Normal Sinus Rhythm the less the damage to the tissue of the Joules A Lov Tilt waveform is one in which the difference in voltage between the start and end of both phases is of the order of 20 compared to the previous differences of some 50 or greater The results of the clinical trials have shown that with a low tilt circa 20 waveform and a 120 Joule energy the efficacy of conversion is currently Itis known that the lower the energy required for conversion from Ventricular shown to be equivalent to the standard tilt circa 50 waveform delivering 0 Joules heart and the less likely the patient is to suffer repeat attacks which formerly This pioneering research was conducted by HeartSine Technologies Ltd in might have ensued from defibrillation However there is a threshold below association with the Royal Victoria Hospital Belfast which the energy might not be effective Volts 1500 Max 1000 Low Tilt circa 20 1 Phase Inter Phase Duration 0 4m KE H e E DT EE iiien ME r pee rop
4. in weight or equivalent to a child of aproximately eight years old or over Copyright 2009 HeartSine Technologies All rights reserved samaritan is a registered trademark of HeartSine Technologies Saver EVO and SCOPE are trademarks of HeartSine Technologies All other trademarks and registered trademarks are the property of their respective owners YOUR PDU 400 Mounting ndicator Shock Button le e e ee Action KEE Arrows Speaker mmer On Off Electrode Drawer Green Tab HeartSine Technologies PDU 400 user manual YOUR PDU 400 On Off button Press this button to turn the device on and off Shock button Press this button to deliver a therapeute shock Status indicator When the indicator is flashing green the PDU 400 is ready for use Attach pads indicator The action arrows around this icon will flash to intruct the user that the PDU 400 pads should be attached to the patient as indicated Safe to touch icon It is safe to touch the patient when the action arrows around this icon are flashing You may perform CPR or check the patient Do not touch icon Do not touch the patient when the action arrows around this icon are flashing The PDU 400 may be analysiing the patients heart rhythm or about to upload to deliver a shock ATTENTION INDICATIONS FOR USE The HeartSine PDU 400 is indicated for use on victims of Sudden Cardiac Arrest wh
5. of your PDU 400 etc please contact us with the updated information HeartSine Technologies PDU 400 user manual 79 000 O OO TROUBLESHOOTING If the status indicator is flashing Red and or device emitting a Beep check the expiry date on your PDU 400 has not expired If the device is within the expiry date switch on the PDU 400 and listen for the voice prompt call for emergency services Then switch off This may correct the problem If not contact HeartSine or your distributor The first time the device plays the message warning low battery during an event it will be possible to deliver at least 10 shocks If this happens the device will still function properly This warning can be played even when the PDU 400 is new and can occur if the storage or operating temperature is or has been very low This does not indicate a fault If the device plays the message warning memory full then no further ECG data or events can be recorded to the memory However the device will still be able to analyse and deliver a shock if required Contact HeartSine Technologies technical support If the device emits 3 beeps rapidly at switch off it has sensed that the ambient temperature is outside of the specified operating range This could also occur during weekly self test Physical damage If the device shows any signs of physical damage contact HeartSine or your distributor During use if the status indicator chan
6. only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Immunity test IEC 60601 test level A Electromagnetic environment guidance 6kV contact Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 8kv air 2kV for power supply lines 1kV for input output lines 1 kV line s to line s 2kV line s to earth lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s Complies Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Complies Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Complies Note Uris the a c mains voltage prior to application of the test level 17 Guidance and manufacturer s declaration electromagnetic immunity The HeartSin
7. storage outside the range or 10 50 C may decrease the shelf life of the device The PDU 400 has no serviceable parts Under no circumstances should the device be opened or repaired as there could be danger of electric shock If damage is suspected the PDU 400 must be replaced immediately For disposal in accordance with the European WEEE Directive contact your HeartSine Distributor Do not switch device on unneccessarily as this may reduce the standby life of the unit The PDU 400 is a self contained device Do not use any unauthorized accessories with the PDU The PDU 400 may not function properly if non approved accessories are used HeartSine Technologies PDU 400 user manual AFTER USE Switch Off the PDU 400 Remove pads from the patient and stick together face to face Do NOT dispose of the PDU 400 or any of its parts in normal waste Return it to your distributor for disposal or replacement DATA MANAGEMENT Contact HeartSine or your distributor about the After Use Data Management Service Distributor information Withdraw the memory card from PDU 400 Insert the memory card into your card reader connected to a PC Launch the HeartSine Saver EVO utility and print or save the file as an Adobe PDF Do NOT attempt to read the memory card with any program other than Saver EVO Do NOT FORMAT the card 11 SERVICE AND MAINTENANCE HeartSine recommends users pe
8. to be put Dry wet skin Either press SHOCK button or perform CPR for 2 minutes or 5 cycles Alternate with second person after one cycle until emergency services arrive HeartSine Technologies PDU 400 user manual Technical Data Physical Size 24 5x16x7 5cm Weight 1 1kg 2 4 lbs Environmental operating limits Operating temperature 0 to 50 C 32 to 122 F Standby temperature 10to 50 C 50 to 122 F Relative humidity 5 to 95 non condensing Enclosure IEC 60529 EN 60529 IP44 Altitude Oto 15 000 feet 0 4 575 meters Shock MIL STD 810F Method 516 5 Procedure 40G s Vibration MIL STD 810F Method 514 5 Procedure 1 Category 4 MIL STD 810F Method 514 5 Procedure 1 Category 7 Patient analysis system Method Sensitivity Specificity User Interface Visual Prompts Audible prompts Languages Controls Defibrillator performance Times to shock delivery fresh battery or after 6 shocks Fromswitchon Less than 20 seconds From ShockAdvised Less than 12 seconds Following CPR Typically 9 seconds Meets ISO 60601 2 4 and AAMI DF80 2003 Meets ISO 60601 2 4 and AAMI DF80 2003 Illuminating icons Extensive audible prompts Contact your HeartSine authorised distributor Two buttons On Off and Shock Low Tilt waveform specification Evaluates patient s ECG ICG and patientimpedance Battery Battery type Battery capacity Standby life Electrodes Type
9. PERSONAL DEFIBRILLATION UNIT WT e User Manual ENGLISH www heartsine com INTRODUCTION The HeartSine PDU 400 is a semi automatic external defibrillator designed for fast delivery of defibrillation electric shock treatment on victims of sudden cardiac arrest SCA The PDU 400 is designed to operate in accordance with the joint European Resuscitation Council ERC and American Heart Association AHA 2005 guidelines on Cardiopulmonary Resuscitation CPR and Emergency Cardiovascular Care ECC Sudden Cardiac Arrest SCA Sudden cardiac arrest is a condition in which the heart suddenly stops pumping effectively due to a malfunction of the heart s electrical system Often victims of SCA have no prior warning signs or symptoms SCA can also occur in people with previously diagnosed heart conditions Survival for an SCA victim depends on immediate cardio pulmonary resuscitation CPR The use of an external defibrillator within the first few minutes of collapse can greatly improve the patients chances of survival Heart attack and SCA are not the same though sometimes a heart attack can lead to a SCA If you are experiencing symptoms of a heart attack pain pressure shortness of breath squeezing feeling in chest or elsewhere in the body seek emergency medical attention immediately Ventricular Fibrillation The normal electrical rhythm by which the heart muscle contracts to create blood flow around the body is
10. ce electrocardiogram Even after a Shock advised decision has been made the PDU 400 analysis detection system continuously assesses the patient s ECG If the patient s heart rhythm spontaneously returns to a non shockable rhythm the PDU 400 will automatically disarm and advise the operator ECG Test Performance 90 One Sided Lower EE Sample Size l U TE Results Confidence Limit High Rate broad complex Ventricular Tachycardia HRVT Sensitivity gt 75 without cardiac output High Rate broad complex Ventricular Tachycardia HRVT with Specificity gt 95 100 100 cardiac output HeartSine Technologies PDU 400 user manual Technical Data Guidance and manufacturer s declaration electromagnetic emissions The HeartSine PDU 400 is intended for use in the electromagnetic environment specified below The customer or user of the HeartSine PDU 400 should assure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance D les RF emissions Harmonic emissions Siapanaieanis IEC 61000 3 2 PP Voltage fluctuations flicker Not applicable emissions Guidance and manufacturer s declaration electromagnetic immunity The HeartSine PDU 400 is intended for use in the electromagnetic environment specified below The customer or user of the HeartSine PDU 400 should assure that it is used in such an environment RF emissions CISPR 11 The HeartSine PDU 400 uses RF energy
11. e PDU 400 is intended for use in the electromagnetic environment specified below The customer or user of the HeartSine PDU 400 should assure that it is used in such an environment Immunity test IEC 60601 test level oe Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the HeartSine PDU 400 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter 3 Vrms Recommended separation distance Conducted RF 150 kHz to 80 MHz Not applicable IEC 61000 4 6 outside ISM bands 12 gt 80MHz to 800 MHz 10 Vrms Not applicable d x i 150 kHz to 80 MHz in ISM PP E bands Radiated RF 10 Vim q 22 p 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz 1 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ko Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from struc
12. e re ro tT ro gt Land 1 0 1 2 3 9 10 11 32 13 md 500 2 Phase 1000 Thelowtiltwaveform characteristics for a 120J pulse are shown below Resistance Ohms T af gt af SS af o RSR Waveform Voltages Waveform Duration v Tilt 3 3 4 5 5 5 7 10 11 15 Arrythmia detection algorithm The HeartSine PDU 400 incorporates an innovative new algorithm for the detection of shockable heart rhythms This new algorithm uses two sensor technologies to determine if a therapeutic shock is required Electro cardiogram ECG detection is coupled with impedance cardiogram ICG to determine ifa suspected victim of Sudden CardiacArrest SCA requires a therapeutic shock Detection system description During the periods of patient analysis the PDU 400 analysis detection system continuously analyzes both the ECG and ICG signals If the presence of a shockable rhythm is confirmed typically 6 to 8 seconds of analysis then the PDU 400 shall provide a Shock advised audible and visual prompt A No shock advised is provided otherwise The PDU 400 analysis detection system has been designed to provide a no shock advised decision for ECG arrythmias consisting of but not limited to Normal sinus rhythm Ventricular Tachycardia which is not HRVT i e not high rate or broad complex Bradycardia Pulseless electrical activity PEA Asystole or fine ventricular fibrillation the peak to amplitude lt 200yV The PDU 400 anal
13. ges from green to red and the device starts to beep there is insufficient battery capacity to deliver a shock The device will continue to analyze the patient s heart rhythm and advise CPR If you have completed the troubleshooting steps above and you find the device is still not working correctly contact your distributor or HeartSine Technical Support at support heartsine com HeartSine or its authorized distributors are not obliged to replace or repair under warranty if The device has been opened 2 Unauthorized modifications have been made 3 It has not been used in accordance with the Indications for Use and instructions provided in this Manual 4 The serial number has been removed defaced altered or by any other means made unreadable 5 The device is used or stored outside its indicated temperature range 13 KEEP CALM LIFE SAVING IS SO SIMPLE Available as a pocket folder Quick Reference 1 2 PERSON NOT RESPONSIVE NO SIGNS OF LIFE Perform CPR until a GENERAL Check breathing open the airway PDU 400 is available CES vw serice woa verg ft List en Co Remove patient from a risk area Ensure your own safety Engage other people to help you get PDU 400 Switch on PDU 400 4 and follow 5 Open PDU 400 remove electrodes peel electrodes from instructions Remove clothes SE SC pads of electrodes to bare chest as shown in If necessary shave part of chest where electrodes are
14. ich causes the heart muscle to contract to create blood flow around the body Self Test A self test is an automatic test that is used to check that the PDU 400 is working correctly Ventricular Fibrillation Is a life threatening heart rhythm that is treatable with an electrical shock using the PDU 400 19 HeartSine HeartSine PDU 400 UNIT 5 5 Years guarantee 5 5 Years shelf time of battery and electrodes Wall bracket User Manual DATA MANAGEMENT amp ACCESSORIES Saver EVO Software Saver Software CD ROM amp License Worldwide Headquarters Manufactured by HeartSine Technologies Inc HeartSine Technologies Ltd 105 Terry Drive Canberra House Newtown 203 Airport Road West PA 18940 USA Belfast BT3 9ED UK Tel 1 215 860 8100 Tel 44 0 28 9093 9400 Fax 1 215 860 8192 Fax 44 0 28 9093 9401 www heartsine com Authorised Distributor C 0120 H024 001 100 4 English February 2009
15. ined that the PDU 400 is safe to use in conjunction with oxygen mask delivery systems However to avoid the risk of an explosion it is strongly advised that the PDU 400 should not be used in the vicinity of explosive gases This includes flammable anaesthetics or concentrated oxygen The HeartSine PDU 400 must only be used on patients over 25 kilograms 55 pounds in weight or equivalent to a child of approximately eight years old or over Proper placement of the PDU 400 s pads is critical Strict observance of pad positioning instructions as indicated in the section HOW DO DEFIBRILLATE and on the device is essential Care must be taken to ensure pads are adhered to the patient s skin properly Wrong placement or air between pads and skin could burn skin Slightly red skin after shock therapy is normal Periodic checks of this device must be undertaken to ensure amongst other things that the HeartSine PDU 400 has not become damaged in any way Check the green LED is flashing every 5 seconds the red light is not flashing the device is within expiry date and free from any physical damage The PDU 400 is a single use item and must be replaced after each use or if the pouch that seals defibrillation electrodes has been broken or compromised in any way The PDU 400 with its battery pads and electrodes is designed to operate in the temperature range of 0 C to 50 C Use of device outside this range may cause malfunction Standby
16. known as Normal Sinus Rhythm NSR Ventricular Fibrillation VF caused by chaotic electrical signals in the heart is often the cause of SCA In victims of SCA itis possible to re establish normal sinus rhythm by means of an electric shock across the heart This treatment is called defibrillation Training SCA is a condition requiring immediate emergency medical intervention Due to the nature of the condition this intervention can be performed prior to seeking the advice of a physician In order to properly diagnose this condition HeartSine recommends that all potential users of the PDU 400 are fully trained in cardiopulmonary resuscitation CPR basic life support BLS and in particular the use of an Automated External Defibrillator It is also recommended that this training be kept up to date by means of regular refresher courses as and when recommended by your training provider If potential users of the PDU 400 are not trained in these techniques contact your HeartSine dealer or HeartSine directly either of whom can arrange for training to be provided Alternatively contact your local government health department for information on certified training organisations in your region HeartSine Technologies PDU 400 user manual ABOUT THIS MANUAL It is important that you read this manual before using the HeartSine PDU 400 This manual is presented in support of any training you may have received Please read carefully If you have any que
17. o are exhibiting the following signs Unconscious A No life signs Not breathing The HeartSine PDU 400 is indicated for patients over 25 kilograms 55pounds in weight or equivalent to a child of approximately eight years or over WHEN YOU RECEIVE YOUR HEARTSINE PDU 400 KR o 03 2010 O 0O O T eg Check contents include user manual guarantee card and wall bracket Check that the green light is blinking If so your PDU is ready for use Turn the PDU 400 on and verify that it is operating in the correct manner Listen for the appropriate voice prompts Ensure no warning messages are played Turn the PDU 400 off Check the status indicator is flashing GREEN If there have been no warning messages and the status indicator is flashing GREEN the device is ready for use The flashing GREEN LED indicates the availability of the device for immediate use Check the expiry date Mount bracket on wall using suitable screws or place in suitable storage box Place in an unobstructed and secure location Store the PDU 400 in a clean and dry environment Complete the guarantee card and return to Heartsine or your authorised distributor HeartSine Technologies PDU 400 user manual WHAT DO I DO IF I NEED TO USE IT Gi REMOVE DANGER gt Remove the source of danger or move the victim away from danger Ensure your own safety Shake the victim by the shoulders Speak lo
18. rform regular maintenance checks A suggested maintenance check would be Check the status indicator If the green status indicator is not flashing approximately every 5 seconds a problem has been detected Refer to TROUBLESHOOTING Check the expiration date of the PDU 400 If the date has expired replace with a new device or contact your local HeartSine distributor for replacement lf a warning message is heard when the PDU 400 is turned on or if for any reason you have suspicions that your PDU 400 is not working correctly contact your authorised HeartSine dealer or HeartSine directly for support Support heartsine com The PDU 400 performs a self test routine at midnight GMT on Sunday During this self test period the status light will blink RED The status light shall return to GREEN on successful completion of the self test routine The self test will take no more than 10 seconds to complete TRACKING REQUIREMENTS Under the Medical Devices Regulations we are required to track the location of all medical devices sold It is important that you complete the guarantee card with your details and return to HeartSine Technologies or authorised distributor Your participation will allow us to contact you about important notifications about the PDU 400 such as any future software updates or field safety corrective actions If there is a change in the information you have provided to us such as change of address change in ownership
19. stions contact HeartSine Technologies or your authorised distributor for advice or explanation The information in this document is subject to change without notice and does not represent a commitment on behalf of HeartSine Technologies No part of this manual may be reproduced or transmitted in any form or by any means electrical or mechanical including photocopying and recording for any purpose without the express written permission of HeartSine Technologies Explanation of icons Explanation of the symbols This symbol refers to the user manual This symbol warns that the PDU 400 must be used only ONCE Note Warning Important This symbol warns to dispose of the device through controlled waste or send it back to your distributor Voice prompt This symbol warns that the device needs to be recycled Action Lithium Manganese Dioxide Battery Do not open or destroy Send device back to your distributor Caution This symbol shows the operating Temperature Range 0 C 50 C Standby temperature 10 C 500 Check with local government health department for information about any requirements associated with ownership and use of a defibrillator in the region where itis to be used LJ This symbol shows the expiry date of 032010 the PDU 400 the date after which the device should not be used 29898 The HeartSine PDU 400 is intended to be Tel used only on patients over 25 kilograms 55 pounds
20. tSine Technologies PDU 400 user manual GLOSSARY OF TERMS HeartSine PDU 400 The PDU is a semi Automatic External Defibrillator AED AED semi Automatic External defibrillators are medical devices designed to deliver therapeutics electric shocks intended to correct erratic electrical impulses in the heart Arrhythmia An Arrhythmia is any irregularity in the rhythm or shape of the heart s electrical activity Biphasic Shock A biphasic shock is an electrical current that is passed through the heart firstly in one direction and then in another Cardio Cardiac Any physical or electrical activity associated with the heart Defibrillation Electrodes The Defibrillation electrodes pads are the part of the device that are connected to the patient s chest in order to administer therapy Impedance Measurement Impedance measurement is a check that is performed to check the integrity of PDU 400 patient contact and to determine the resistance of the patient to the passage of electricity Radio Frequency Interference Radio Frequency Interference RFI is radio interference that may cause erroneous operation of electronic equipment Saver EVO Software Saver EVO is software that can be used in conjunction with the data card of the PDU 400 and a suitable card reading device Saver EVO can be used to retrieve and view information about therapy delivered using the PDU Sinus Rhythm Sinus Rhythm is the normal electrical rhythm wh
21. tures objects and people a The ISM industrial scientific and medical bands between 150 KHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile potable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths form fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy TO asses the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured filed strength in the location in which the HeartSine PDU 400 is used exceeds the applicable RF compliance level above the HeartSine PDU 400 should be observed to verify normal operation If abnormal operation is observed additional measures may be necessary such as re orienting or relocating the HeartlSine PDU 400 d Over the frequency range 150 kHz to 80 MHz filed strength should be less than V1 V m Hear
22. udly to the victim Check for breathing open airway if necessary p Get other people to help you to get the PDU 400 to stay with the patient while you call emergency services to help with Cardio Pulmonary Resuscitation CPR O PERFORM CPR Perform CPR until emergency services arrive or the PDU 400 is made available S Open the airway with a head tilt chin lift Give 2 breaths Push hard and fast at a rate of 100 beats per minute 3 5cm deep on patients chest 30 compressions 2 breaths 30 2 or 2 breaths 30 compressions HOW DO I DEFIBRILLATE O SWITCH ON when the PDU 400 becomes available switch ON and follow the Voice Prompts Ce N 4 h A Ex gt LAT af gt WW E ii vi K h AV y OK gd en i 5 JN 3 d Gi A e A e LEE NA X k A M lt 4 d gt E 3 Q EN N i i O ZK y x 28 A gt If necessary shave part of chest where electrodes are to be put Dry wet skin GA OPEN THE ELECTRODE POUCH AND PLACE PADS ON PATIENT Pull out pad drawer Tear open pad pouch Place pads on patient s chest as shown HeartSine Technologies PDU 400 user manual HOW DO I DEFIBRILLATE CONTINUED 8 FOLLOW THE VOICE PROMPTS MAKE SURE NO ONE TOUCHES THE PATIENT WHILE DEVICE IS ANALYSING OR DELIVERING A SHOCK Keep giving CPR for 2 minutes the PDU 400 will tell you when to stop and repeat until the emergency services arrive
23. ysis detection system has been designed to provide a shock advised decision for the following ECG arrhythmias whenever the peak to peak amplitude of the ECG signal is higher than 200yUV Ventricular fibrillation Shockable High Rate Ventricular Tachycardia SHRVT ECG Test Performance 90 One Sided Lower AMINES Sample Size PSHE CU ELIE So JETP 7 Results Confidence Limit Shockable Rhythm Ventricular Fibrillation VF Ge See SE ae Shockable Rhythm High Rate broad complex 8 g Ventricular Tachycardia HRVT Hk i without corresponding ICG data Non Shockable Rhythm I Non Shockable Rhythm me S All other Rhythms 188167 Specificity gt 95 99 99 99 98 The ECG Algorithm Performance The PDU 400 ECG Arrhythmia Analysis Algorithm has been extensively evaluated by using the American Heart Association s AHA database and the Massachusetts Institute of Technology MIT NST database1 The algorithm sensitivity and specificity meets the AAMI DF80 2003 requirements and AHArecommendations The PDU 400 ECG analysis fulfils the Arrhythmi Association for the Advancement of Medical Instrumentation DF80 2003 Standard for Medical electrical equipment Part 2 4 with particular requirements for the safety of cardiac defibrillators including automated external defibrillators Whenever the heart rate is higher than 180BPM a broad complex is present and no cardiac disturbance is detected This cardiac disturbance is determined by analyzing the impedan
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