Home

User Manual - AED Superstore

1. 40 8 RECORDING SAMARITAN AED S USAGEFE 41 8 1 RECORDED ECG INFORMATION ee 41 8 2 EVENTS LOG 42 8 3 AUDIO REC OR DIN Gis NG 42 8 4 OTHER INFORMATION 2 48 0000000 42 9 UNDERSTANDING HOW THE SAMARITAN AED 43 9 1 WHAT IS THE SAMARITAN 2 20 00 000000000 43 92 WHAT DOES A SAMARITAN AED DO 43 9 3 WHAT IS HEART 44 9 4 How DOES THE SAMARITAN AED 2 2 8 45 9 5 WHY IS IMPEDANCE MEASURED 000000000000 48 10 MAINTAINING THE SAMARITAN AED 49 10 1 CHECKING AFTER EACH USE 0000 50 10 2 DAILY CHECKS PERFORM 506000 51 10 3 MONTHLY CHECKS TO PERFORM 51 10 4 CLEANING THE DEVICE ene 52 10 5 STORING THE DEV E net ne en 52 10 6 CONFIGURING THE SAMARITAN AEFD 52 11 ACCESSORIES FOR THE SAMARITAN AEBD 53 12 TROUBLESHOOTINCG 55 13 WARRANTY AND REPAIR
2. ECG Connector ECG Cable ECG Cable The ECG Monitoring Cable uses AMC Multi Clip electrode connector that locks on to both resting snap and diagnostic tab electrodes They can be applied easily with one hand without applying excessive pressure on the electrode site and is more comfortable for the patient and more ergonomic for the health professional HeartSine Technologies Inc Page 25 samaritan AED User Manual How to Use the Samaritan AED ECG Monitoring Cable 1 Locate the yoke of the ECG cable This yoke illustrates the proper placement of the ECG electrodes on the patient Make sure the patient s chest is clean and dry Apply ECG electrodes to the patient s chest as illustrated on the cable yoke 4 Locate the Multi Clip on ECG Cable Notice that each Multi Clip has a small lever This lever is used to clamp onto Or release from the round ECG electrodes Open the Multi Clip levers Match the appropriate color coded Multi Clip with its appropriately positioned electrode as shown on cable yoke diagram and attach by lowering lever 7 Once Multi Clip s are attached to the patient switch on the samaritan AED unit using the On Off key 8 The samaritan AED will begin to analyze the patient s heart rhythm If Shock Advised If an irregular heart rhythm is analyzed that requir
3. 56 14 APPEND Gasa 57 SAMARITAN AED TECHNICAL SPECIFICATIONS 0 000 58 SCOPE BIPHASIC WAVEFORM 61 C ECG ANALYSIS DETECTION SYSTEM DESCRIPTION 0 00 62 Page ii O HeartSine Technologies Inc User Manual User Manual D ECG ARRHYTHMIA ANALYSIS ALGORITHM 27 63 SCOPE BIPHASIC CLINICAL SUMMARY smorvvrnnnvernnnnennnnvvnnnnvennnnsnenennvennnnvennnessenene 65 GLOSSARY EN 68 HeartSine Technologies Inc Page iii User Manual Introduction 1 Introduction This manual explains how to use the Samaritan AED The Samaritan AED is a semi automatic device used for the delivery of external defibrillation therapy to resuscitate victims of sudden cardiac arrest SCA who are unresponsive to stimulus are not breathing or have no signs of circulation The Samaritan AED can also be used in conjunction with the Saver system The Saver system is software and hardware that is used to configure and to analyze the use of the Samaritan AED Information about Saver is provided in the Saver User Manual for that product Note United States Federal Law restricts this device to use by or on the order of a physician 1 1 Regulatory Requirements Defibrillator Tracking Requirements The U S Federal Regulations 21 CFR 821 requires that manufacturers of defibrillators track the location o
4. 12 5 4 ENSURING THE SAMARITAN AED IS WORKING CORRECTLY 13 5 5 WHERE TO PLACE THE 13 6 USING THE SAMARITAN AELD 14 6 1 USEFUL HINTS sekst Ne 14 6 2 QUICK INSTRUCTIONS a a ha aqa ea es 15 6 3 STEP BY STEP INSTRUCTIONS evornnerernnererenevereneverenevennnueserenevenenevennnuvensenenener 16 6 4 POST USE PROCEDURE ai 20 6 5 nar 21 6 6 MANUAL OVERRIDE 00000000 22 6 7 ECG MONITORING CABLE USER 25 O HeartSine Technologies Inc Page i samaritan AED User Manual 6 8 DATA PAK RECHARGEABLE BATTERY AND CHARGER INSTRUCTIONS 28 7 UNDERSTANDING THE SAMARITAN AED 30 7 1 ALTERING THE CONTRAST sic 31 7 2 TURNING OFF THE 31 7 3 UNDERSTANDING VISUAL 6 00000 0000000 32 TA UNDERSTANDING DISPLAY 34 7 5 TEXT VS ICON MESSAGES 37 7 6 ICON MESSAGES sa ae vv 37 7 7 AUDIBLE 8
5. 1 Contrast Controls the contrast of the display On Off Used to turn on and off the Samaritan AED Shock Used to deliver a defibrillation shock to a patient a N Backlight Turns on and off the backlight of the display Manual Override Optional function to manually operate the Samaritan AED samaritan AED Follow Prompts Figure 4 1 Samaritan AED Controls O HeartSine Technologies Inc Page 7 samaritan AED User Manual 4 4 The Samaritan AED Display and Status Indicator The Samaritan AED has a large LCD display and a status indicator The screen will display important information while using the Samaritan AED to help guide the rescuer Unique to the Samaritan AED are text or visual prompts that appear in the lower center of the screen A variety of universal key images coincide with audible prompts to instruct the rescuer each step of the way 1 Satus indicator 5 Battery Level 2 Data 6 Visual Prompts 3 ECG 7 Shocks Delivered 4 Elapsed Time 8 Heart Rate Figure 4 2 Samaritan AED display Page 8 HeartSine Technologies Inc User Manual Quick Overview 4 5 The Samaritan AED Data Pak Battery The Data Pak is a combination battery and data recorder for the Samaritan AED Once inserted into the Samaritan AED it prompts the AED to perform self tests on a regular basis to assure that the Samaritan AED is ready for use The integrated data recorder in the battery gives you data re
6. Inc Page 35 samaritan AED User Manual The Samaritan AED is able to minimize the effects of e Electrical noise e Respiration e Transience due to shock therapy As a consequence of the suppression of these interferences the ECG waveform can be quickly re established after therapy to resume ECG analysis immediately Patient Therapy Information The LCD displays information relating to both the patient and the AED The four types of information displayed are Heart rate this can display up to 240 beats minute BPM Elapsed time this can display up to 99hrs 59mins 59secs Charging status this graphic displays current therapy energy Patient timer this one minute countdown timer indicates when Samaritan AED is disabled and CPR may be safely applied e Shock counter this displays the number of shocks delivered since the device was switched on e Status icon this displays either a or symbol that tells you if data recording is active between the Samaritan Data Pak Battery and the Samaritan AED gt The Samaritan AED can be used to administer therapy while is displayed but data will not be recorded e Shocks Remaining Indicator This is only displayed when the Data Pak battery capacity drops to a level where 10 or less shocks may be delivered It indicates the appropriate number of shocks that may be delivered before the battery is depleted Page 36 HeartSine Technologies Inc User
7. using Saver 7 3 Understanding Visual Indicators Patient cable indicator m samaritan AED Status indicator Shock button indicator Figure 7 3 Samaritan AED employs three different indicators in order to signal that something is wrong or to tell you the status of the device These are e Status indicator e Patient cable indicator e Shock button indicator The following sections provide you with information on understanding the messages conveyed by each of these indicators Page 32 HeartSine Technologies Inc User Manual Understanding the Samaritan AED Interface Status Indicator The Status indicator is located above the On Off button on Samaritan AED The Status indicator verifies that the Samaritan AED Data Pak is inserted and that the self test has been successful The Status indicator can be interpreted by the following e the Status indicator is blank Samaritan AED is powered the self test has been successful Ifthe red exclamation mark is displayed in the Status indicator and is steady Samaritan AED is not powered If the red exclamation mark is flashing in the Status indicator the Samaritan AED has detected one or more errors A Do not use Samaritan AED if a flashing red exclamation point is displayed in the Status indicator Patient Cable Indicator The patient cable indicator is a flashing amber indicator located next to the patient cable connector The indicator will flas
8. 3 Lead Monitoring Cable AAMI 3 Lead Monitoring Cable IEC AED Prep Kit Samaritan AED Training System Samaritan AED Trainer Samaritan AED Trainer Replacement Battery Charger Samaritan AED Trainer Defibrillation Pad 1 set Samaritan AED Trainer Nylon Carry Case Samaritan AED ECG Defibrillation Simulator HeartSine Technologies Inc User Manual Troubleshooting 12 Troubleshooting This chapter provides some useful troubleshooting information for the Samaritan AED e Ifthe Samaritan AED indicator is not grey or is flashing e Check that a Data Pak is inserted into the Samaritan AED e Check that the Data Pak is correctly inserted When inserting the Data Pak you will hear a click once it is properly seated lf the unit is properly powered the Status Indicator will remain solid grey Contact support HeartSine com if you find that the device is still not working correctly HeartSine Technologies Inc Page 55 samaritan AED User Manual 13 Warranty and Repair HeartSine Technologies will provide the following services under warranty e All faulty components which fail due to defective manufacturing will be replaced free of charge for the following periods from the original date of purchase e Samaritan AED 5 years e Data Pak 2 years e HeartSine is responsible for extensions of the warranty period only when specifically agreed between HeartSine Technologies and the distributor A
9. Joules following the set CPR protocol until NSR Normal Sinus Rhythm is restored 200 only available for patients with impedance greater than or equal to 250 In the case of lt 25Q further therapy will continue at 150J gt The escalating energy protocol be configured using Saver LU Refer to the Saver User Manual for details on configuring the escalating energy protocol gt Samaritan AED will automatically disable energy charging and delivery for one minute at the end of any sequence of three automated or manual deliveries to allow for CPR Biphasic Waveform Description The Samaritan AED generates therapy in the form of a Biphasic truncated exponential wave The patient s impedance is measured and this forms the basis of the Waveform parameters which are adjusted by Samaritan AED before therapy Samaritan AED charges the internal storage capacitors to a selected level The output pulse phase is adjusted to ensure delivery of the selected level of energy 29 Phase and Phase B of the output pulse envelope are always of the same duration O HeartSine Technologies Inc Page 47 samaritan AED User Manual 9 5 Why is Impedance Measured An impedance measurement is performed when a Samaritan AED is switched on This measurement is important for the following reasons It checks the integrity of the pad patient contact and of the pad leads If the impedance is too high patient pad contact is
10. Manual Understanding the Samaritan AED Interface 7 5 Text vs Icon Messages Depending on the version of software operating your Samaritan AED you will see either text or icons instructions in the lower portion of the display See the below example for Stand Clear TEXT MESSAGES ICON MESSAGES 7 6 Icon Messages Icon messages can be displayed on the LCD to signal information to the user visually Icons are used to provide a universally accepted means of communicating with an operator making the Samaritan AED virtually language independent The Icon Messages are accompanied by audible prompts in most cases The following is a list of icons that may appear during operation Display Icon YZ Apply Pads to Patient PLUG IN PAD CONNECTOR HeartSine Technologies Inc Page 37 samaritan AED User Manual MONITORING or Analyzing SHOCK ADVISED DON T TOUCH PATIENT ON OFF BUTTON PRESSED STAND CLEAR CHARGE 100J o READY TO SHOCK CHARGE TO 150J 2 CHARGE TO 200J PRESS ON OFF KEY ONCE CHARGE 230J 5 38 O HeartSine Technologies Inc User Manual Understanding the Samaritan AED Interface CHECK PADS PRESS SHOCK KEY ONCE PRESS CONTRAST KEY CHECK PATIENT AO PRESS KEY XX SHOCKS LEFT AW PRESS ANY KEY If YOU CAN READ THIS MESSAGE Serial number Self Test Failed XXXXXXXX DEMO VERSION 6
11. Pak SBP 002 Instructions for Charging and Use provided with the Data Pak battery Warranty HeartSine Technologies warrants the Data Pak SBP 002 battery to be free from defects in material and workmanship until the expiration date shown on battery Do not use the Data Pak SBP 002 battery after its expiration date HeartSine Technologies warrants the SBP 010 charger for one 1 year from date of purchase A Insertion of the SBP 002 into a Samaritan AED unit configured with software versions below 1 0 24 may result in corruption of the SBP 002 Corruption will render the SBP 002 unusable HeartSine Technologies Inc Page 29 samaritan AED User Manual 7 Understanding the Samaritan AED Interface This chapter contains the following sub sections Altering the Contrast Turning Off the Backlight Understanding Visual Indicators Understanding Display Information Icon Messages Audible Instructions Figure 7 1 The Samaritan AED uses a large high resolution Liquid Crystal Display LCD screen The screen displays information as text icons and numerically Audible prompts are also given from the AED speaker The visual display can be altered e Directly by Samaritan AED operator e Indirectly by PC programmed configuration LU Refer to the Saver User Manual for further information on configuring the LCD display using Saver This chapter provides you with the information that you require to succes
12. Please Note HeartSine Technologies or the distributor are not obliged to carry out service under warranty if e Unauthorized modifications have been made to the device e Non standard components are used e The user has not used the device in accordance with the instructions provided in this manual e The serial number of the apparatus is removed defaced misused or altered e The device pads or batteries are stored or used operationally outside of environmentally specified conditions listed within this manual e Defibrillation pad packaging is not returned Any claims made under warranty must be directed via the distributor from whom the device was originally purchased The distributor before carrying out service under warranty may require evidence of purchase The product must be used in accordance with the user manual and for the purpose that it was intended If you have a query please contact support HeartSine com for assistance Page 56 HeartSine Technologies Inc User Manual Appendix 14 Appendix This chapter contains the following sub sections A Samaritan AED technical specifications SCOPE Biphasic waveform specifications ECG analysis detection system description D ECG arrhythmia analysis algorithm performance E SCOPE Biphasic waveform clinical summary O HeartSine Technologies Inc Page 57 samaritan AED User Manual A Samaritan AED Technical Specifications PHYSIC
13. Quick Overview 5 1 5 2 Preparing the Samaritan AED for Use This chapter contains the following sub sections Quick List Installing the Samaritan Data Pak Battery Ensuring the Samaritan AED is Working Correctly Where to Place the Samaritan AED It is imperative that the AED is always prepared for operational use since it is designed for use in emergency situations This section provides you with information that will help you ensure that the device is always ready for emergency use Quick List Ensure that you follow this quick list to make certain that the Samaritan AED is ready for use Ensure that Samaritan AED is clean and dry Insert the Samaritan Data Pak Battery into Samaritan AED Switch on the Samaritan AED Ensure the Status Indicator is blank indicating ready for use Switch off the Samaritan AED Position the Samaritan AED in a suitable and pre arranged location The Samaritan AED Data Pak Battery The Samaritan Data Pak Battery is the power source for the Samaritan AED and is also used to store configuration information for your Samaritan AED This configuration information can be changed using Saver gt Saver is software that is used to configure the Samaritan AED and to view information that has been saved to the Samaritan Data Pak Battery during the use of Samaritan AED HeartSine Technologies Inc Page 11 samaritan AED User Manual 5 3 Installing the Samaritan AED Data Pak Battery Befor
14. is UNCONSCIOUS NOT BREATHING WITHOUT CIRCULATION Insert Pod Connector Apply To AED Follow Prompts Pads To Patient ta www heartsine com Figure 6 1 Samaritan AED Quick Instruction Card O HeartSine Technologies Inc Page 15 samaritan AED User Manual 6 3 Step by Step Instructions Preparing patient It is essential that the Samaritan AED Disposable Defibrillation Electrodes be connected correctly to the patient It is these electrodes that monitor the heart and deliver the therapeutic shock treatment When preparing the patient for their therapy you should use the following checklist to ensure that patient is correctly prepared Dry the patient s chest and remove excessive hair Ensure the disposable defibrillation electrodes are properly attached to the patient s skin Ensure the patient is not in contact with metal objects To connect the electrodes to the patient 1 Press the On Off button once to switch on the Samaritan AED 2 Open the defibrillation electrode pads package Remove the protective liner from the pads Pads should not be damaged and conductive gel should not be dried out 4 Firmly place the pads sticky side down on the patient s bare chest as indicated on the electrode label 5 Place one pad just below the right collarbone and place the other pad over the patient s ribs in line with the armpit and below the left breast See Figure 6 2 Proper Pad Placement 6 En
15. AL Size 20 5cm H x 25 8cm W x 6cm D 8 1in H x 10 2in W x 2 4in D Weight 1 9kg 4 2Ibs including battery and 2 sets of electrodes DEFIBRILLATOR Waveform SCOPE Self Compensating Output Pulse Envelope Biphasic Escalating waveform Optimized biphasic waveform compensates energy slope and envelope for patient impedance Energy Selection Pre configured automated protocol escalating from 100J 150J to 200J user configurable Manual override 100J 150J 200J and 230J Charge Time 100J in less than 6 seconds and 200 in less than 10 seconds with new non rechargeable battery pack typical Shock Cycle Time lt 60 seconds for three analysis shock cycles typical Controls On Off shock manual override display contrast and backlight LCD PATIENT ANALYSIS SYSTEM Method Evaluates patient s ECG signal quality electrode contact integrity and patient impedance to determine if defibrillation is required Sensitivity Specificity Meets AAMI DF 39 requirements DISPLAY Display Type High Resolution LCD switchable backlight Display Size 100 mm x 75 5 mm 4 in W x 3 in H Frequency Response 1 to 20 Hz Heart Rate 30 to 280 BPM ECG View Time 3 8 seconds Sweep Speed 25 mm sec Page 58 HeartSine Technologies Inc User Manual Appendix Leakage Current lt 100 uA Display Information ECG waveform amp heart rate optional shock counter elapsed time battery capacity gauge CPR duration graph e
16. D will alert you that it is safe to touch the patient It will monitor analyze and display the patient s ECG until the unit is detached from the patient or switched off Post Use Procedure Once therapy is completed check the Data Pak energy level to determine how much battery capacity remains If your protocols call for it power off the device and replace Data Pak Press On off button to turn the Samaritan AED off e Ifthe Samaritan AED is displaying 10 shocks or less completely remove the Data Pak from the Samaritan AED and dispose of it safely e Insert a new Data Pak in the Samaritan AED if required e Clean the Samaritan AED properly as described in the Cleaning and Maintenance section of this manual e Check the Status Indicator e Position the Samaritan AED in a suitable and pre arranged location e Discard used defibrillation electrodes and check that new electrodes are available Page 20 HeartSine Technologies Inc User Manual Using the Samaritan AED 6 5 Aborting a Shock SAM 001 SAM 002 and SAM 003 Models Samaritan AED allows you to abort a shock using the Manual Override button You may disarm the Samaritan AED when the Samaritan AED is charging or has reached the full charge state when the Samaritan AED advises to press the Shock button After a shock has been aborted the Samaritan AED will return to automatic mode and begin assessing the patient s rhythm To abort a shock during defibrillator c
17. HEARTSINE TECHNOLOGIES samaritan AED User Manual User Manual User Manual Table of Contents 1 INTRODUCTION vr 1 1 1 REGULATORY REQUIREMENTS 1 2 OVERVIEW OF THIS MANUALIL 3 2 1 NORS INU sa 3 22 VANNS 3 2 3 REFERENCES TO OTHER SOURCES OF 00 4 2 4 ETSTSOR INSTRUCTIONS ee 4 2 5 BUTTON GN 4 3 WARNINGS amp CAUTION S 5 3 1 ELECTROMAGNETIC INTERFERENCE PRECAUTION 20 0000 5 3 2 TEMPERATURE AND HUMIDITY CONSTRAINTS 5 4 QUICK OVERVIEW 6 4 1 UNDERSTANDING THE 3 DIFFERENT SAMARITAN AED MOpElIS 6 4 2 INDICATIONS FOR USB eee EG 6 43 THE SAMARITAN AED 5 0 00000000 7 4 4 THE SAMARITAN AED DISPLAY AND STATUS INDICATOR 8 4 5 THE SAMARITAN AED DATA PAK 9 46 SAMARITAN AED CARRY 10 47 INTERNATIONAL 8 0 0 0 0 22 606900 0 10 5 PREPARING THE SAMARITAN AED FOR USE 11 5 1 OMTRENT NG 11 52 THE SAMARITAN AED DATA PAK BATTERY 22 00 00 0 11 5 3 INSTALLING THE SAMARITAN AED
18. Sine Technologies Inc User Manual Recording Samaritan AED s Usage 8 Recording Samaritan AED s Usage This section contains the following sub sections Recorded ECG Information Events Log Audio Recording Other Information Recorded A sophisticated event recording system is automatically started each time the Samaritan AED is powered on The battery pack can hold all the information gathered during a battery lifetime without the need for retrieval gt A battery lifetime can be up to 12 hours monitoring with the backlight on or 16 hours monitoring with the backlight off Each time the Samaritan AED is powered on a new session is begun and the data recorded during this session is retrievable as a block via Saver LU Refer to the Saver User Manual for information on retrieving information saved by the Samaritan Data Pak Battery The four types of information the Event Recording System records are ECG information events that occur during the therapy sounds recorded within five feet 1 5 metres of the device and other information such as date time and serial number This chapter provides information on each of these different types of information 8 1 Recorded ECG Information The Samaritan AED is able to record the electrical activity of the heart ECG before during and after therapy gt A clear indication of the heart s activity is given Transience and other adverse effects are suppressed HeartS
19. amaritan AED Part Number SAM 001 SAM 002 SAM 003 SBP 001 SBP 002 SBP 010 SDE 201 SDE 210 SDU 001 SDU 002 SDU 003 Unit Samaritan AED Defibrillators Samaritan AED Advanced Text IconECG Display and Manual Override Samaritan AED Basic Text Icon amp ECG Display Capability Samaritan AED Basic Text Icon Only Samaritan Data Pak Battery Samaritan Data Pak Battery non rechargeable Samaritan Data Pak Battery rechargeable Samaritan Data Pak Charger Samaritan AED Defibrillation Electrodes 1 set of defibrillation electrodes 10 sets of defibrillation electrodes Samaritan AED Data Storage and Recall Samaritan AED Data Recovery Unit SDRU amp SAVER Software System Additional SAVER Data Management amp Review Software Licenses Additional Samaritan AED Data Recovery Units SDRU HeartSine Technologies Inc Page 53 samaritan AED SSS 001 SSS 002 SSS 011 SSS 012 SSS 013 SSS 014 SSS 021 SAC 009 SAC 010 SAC 011 STU 001 STU 002 STU 003 STU 004 STU 005 Page 54 User Manual Samaritan AED Carrying Cases and Storage Systems Soft Carrying Case Samaritan AED Hard Carrying Case Samaritan AED Rescue Cabinet with Alarm Deluxe Designed to fit AED amp 02 tank Rescue Cabinet with Alarm Basic Designed to fit AED Wall Bracket Samaritan AED Vehicle Bracket Samaritan AED AED Wall Sign includes triangular wall mount Samaritan AED Accessories
20. ar the audio prompt Do not touch the patient Once the Samaritan AED unit is charged you will see the Shock button illuminate hear a constant tone and the audio prompt Shock advised press the Shock button now Press the Shock button to deliver the therapy A Do not touch the patient while defibrillation therapy is in process Defibrillation energy can cause injury The patient s heart rhythm will automatically be analyzed to determine if the shock was successful If the Shock button is not pressed within 30 seconds after recommendation the device will disarm and resume analyzing the patient s heart rhythm HeartSine Technologies Inc Page 19 samaritan AED User Manual 6 4 Follow the audio and visual instructions to repeat therapy if the initial shock was unsuccessful e The Samaritan AED initially uses the base energy level to provide the shock You can specify the base energy level using Saver whenever you configure the device If the initial shock is unsuccessful the device will use the next highest energy level that has been specified in the configuration of the AED to deliver another shock After three shocks or after a successful shock you will be prompted to check patient and if needed to perform CPR for 60 seconds After this time has elapsed automated patient analysis will resume f no shock has been advised during any of the three automated shock delivery sequence Samaritan AE
21. asic waveform system O HeartSine Technologies Inc Page 67 samaritan AED User Manual Glossary Battery Pack The Samaritan Data Pak Battery is a special battery that supplies power to Samaritan AED and is also able to save information about the use of the device Biphasic Shock A biphasic shock is an electrical current that is passed through the heart first in one direction and then in another Defibrillation Electrodes Defibrillation Electrodes are pads that are connected to the patient s chest in order to administer therapy Electromagnetic Interference Electromagnetic interference is radio interference that may cause erroneous operation of Samaritan AED Impedance Measurement Impedance measurement is a check that is performed to verify the integrity of pad patient contact Manual Override The Manual Override is a feature of Samaritan AED that allows the operator to abort a shock or manually administer a shock Samaritan AED Samaritan AED is a semi automatic device used for the delivery of external defibrillation therapy to resuscitate victims of sudden cardiac arrest SCA who are unresponsive to stimulus are not breathing or do not exhibit signs of circulation Saver Saver is software that can be used in conjunction with Samaritan AED to retrieve and view information about therapy delivered using Samaritan AED and to configure Samaritan AED so that you can tailor the device to suit your requ
22. bout your Samaritan AED and various key features Before using the Samaritan AED familiarize yourself with the device by reading through this chapter 4 1 Understanding the 3 Different Samaritan AED Models The Samaritan AED is available in 3 different configurations Each configuration differs in the type of optional capabilities that are enabled To determine which model Samaritan AED you have turn over your Samaritan AED and look for the Model number SAM 001 SAM 002 or SAM 003 on the Model Number label Samaritan Model Text Icon ECG Manual Type Number Display Display Override SAM 001 Yes Yes Yes Standard SAM 002 Yes Yes Basic SAM 003 Yes No No 4 2 Indications for Use The HeartSine Samaritan AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs e Unconscious e Not Breathing e Without Circulation no pulse A The SamaritanAED is intended for use by personnel who have been trained in its operation Users should have received training in basic life support AED advanced life support or a physician authorized emergency medical response training program The Samaritan AED is not currently indicated for use on children less than 8 years old Page 6 HeartSine Technologies Inc User Manual Quick Overview 4 3 The Samaritan AED Controls The Samaritan AED has 5 Control buttons These controls have specific operational aspects that can be helpful when using the Samaritan AED
23. complete and you will hear the following audio prompt Deliver shock now The display will provide a prompt indicating ready to shock Press the Shock button to deliver the selected energy After the shock is administered you will hear the following audio prompt Shock delivered The Samaritan AED will revert back to the automatic mode after delivery of the shock If required the process can be repeated either under the automatic or manual mode gt After any sequence of three automated or manually delivered shocks the Samaritan AED will pause for 60 seconds to allow for CPR to be performed gt Performing Cardiopulmonary Resuscitation CPR on a patient connected to Samaritan AED may interfere with ECG monitoring The Samaritan AED will automatically pause for 60 seconds after each set of 3 shocks to allow for CPR to be performed without affecting the ECG analysis After the pause for CPR the Samaritan AED will resume ECG rhythm analysis The Samaritan AED will provide an audio prompt to Stop CPR at the completion of the pause for CPR The manual override is an optional feature and should only be used under the authorization and direction of a medical director If you are an advanced user and have been authorized by your medical director to use the Manual Override feature the Manual Override feature will allow you to select the energy and charge the defibrillator without having to wait for the ECG rhythm anal
24. configures itself with the default settings in the Samaritan Data Pak Battery A If the STATUS INDCATOR is solid gray the Samaritan AED is ready for use If the STATUS INDICTOR box displays a static or flashing Exclamation Mark check your battery install before date and capacity or contact HeartSine Technologies for support 5 5 Where to Place the Samaritan AED The Samaritan AED should be placed in an easily accessible location when not in use The Status Indicator must be clearly visible The AED performs periodic self checks with a Data Pak installed to ensure that it remains ready for use gt It is recommended that Samaritan AED is stored with a Samaritan Data Pak Battery installed HeartSine Technologies Inc Page 13 samaritan AED User Manual 6 Using the Samaritan AED This chapter contains the following sub sections Useful Hints Quick Instructions Step by Step Instructions Post Use Procedures Manual Override Instructions ECG Monitoring Cable Instructions Data Pak Rechargeable Battery Instructions This chapter provides you with all of the instructions that you need to use the Samaritan AED in an emergency The Quick Instructions section has been designed for immediate reference in times of emergency but users should also read this section whenever they receive the equipment It is imperative that the patient is fully prepared prior to use of a Samaritan AED This chapter also provides you with instructions
25. cording reliability Data Pak Non Recharaeable samaritan AED Figure 4 3 Samaritan AED and Data Pak Data Pak Rechargeable A The Samaritan Data Pak Battery must be installed into Samaritan AED by the install before date printed on the pack Once installed the Samaritan Data Pak has a 2 year standby life See Appendix A for Data Pak capacity The Data Pak is a non rechargeable battery and must be disposed of carefully when depleted HeartSine also produces a Data Pak battery that is rechargeable see chapter 6 HeartSine Technologies Inc Page 9 samaritan AED User Manual 4 6 Samaritan AED Carry Case The Samaritan AED carrying case is available to carry your Samaritan AED plus other items you may need in a rescue Below is an example of what the carry case holds Window to view status indicator Pocket for Prep Kit Pockets hold 2 defibrillation pads Place for the quick instructions Space for a spare battery Samaritan AED securely screws down into bag Figure 4 4 Samaritan AED Carry Case 4 7 International Considerations The Samaritan AED is available for use worldwide With this in mind there may be subtle differences in the appearance of Samaritan AEDs sold in different territories to accommodate for language variations These differences relate to the top label of the Samaritan AED and the spoken voice prompts Page 10 HeartSine Technologies Inc User Manual
26. e you begin to use the Samaritan AED the Samaritan Data Pak Battery must be fitted correctly This is easily achieved as the battery can only be inserted in one direction To insert the Samaritan Data Pak Battery Slide the Samaritan Data Pak Battery firmly into the slot on the right hand side of Samaritan AED until it clicks as illustrated in Figure 5 1 below Push in firmly until you hear and feel a click 4 Gav w The Status indicator will change from an exclamation point to solid gray once battery is installed Figure 5 1 Inserting the Samaritan Data Pak Battery gt Once the battery pack has been successfully inserted the red exclamation mark on the Status Indicator on the front panel of the Samaritan AED will disappear Page 12 HeartSine Technologies Inc User Manual Quick Overview 5 4 Ensuring the Samaritan AED is Working Correctly After insertion of the Samaritan Data Pak battery the Samaritan AED should be switched on to ensure that the system is functioning correctly This is indicated by the voice prompt Apply Pads in the absence of defibrillation pads being connected Check that there is sufficient battery power shown by the battery indicator on the LCD screen and that no low battery warning voice prompts have been given An automatic self test occurs weekly and each time the Samaritan AED is switched on For this test the AED performs basic checks and
27. ecificity gt 99 NSR Specificity gt 95 NSR Specificity gt 95 NSR Performance Results 94 75 100 99 47 90 One Sided Lower Confidence Limit 93 66 100 100 A Association for the Advancement of Medical Instrumentation DF 39 1993 Standard for Automatic External Defibrillators and Remote Control Defibrillators Arlington VA AAMI 1993 B Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety and Efficacy AHA Task Force on Automatic HeartSine Technologies Inc Page 63 samaritan AED User Manual External Defibrillation Subcommittee on AED Safety and Efficacy Circulation 1997 Vol 95 1677 1682 C AHA and MIT NST databases Page 64 O HeartSine Technologies Inc User Manual Appendix E SCOPE Biphasic Clinical Summary The HeartSine SCOPE Biphasic waveform has been clinically tested in a three phase validation program Numerous animal studies have been conducted to compare the efficacy of the SCOPE biphasic to other defibrillation waveforms Results of these studies have been published Optimization of transthoracic ventricular defibrillation biphasic and triphasic shocks waveform rounding and synchronized shock delivery Kidwai Mcintyre A Anderson J Adgey AAJ Journal of Electrocardiology Vo
28. es defibrillation such as ventricular fibrillation the samaritan AED will instruct the operator to attach the defibrillation pads through audible prompts Apply Pads Once defibrillation pads are attached to the patient the samaritan AED will operate in it s normal AED mode 29 Defibrillation can only when defibrillation pads connected to the samaritan AED Page 26 O HeartSine Technologies Inc User Manual Using the Samaritan AED Troubleshooting If the following audio prompts occur while using the ECG Monitoring Cable Check Pads and Pads Connector 1 Check ECG electrodes Make sure they are attached to the patient correctly Assure that ECG cable connector is plugged into samaritan AED firmly If no ECG trace is displayed on the screen of the samaritan AED e Turn over the samaritan AED and check that model number is SAM 001 or SAM 002 If SAM 003 ECG will not be displayed A It should be noted that the ECG cable has an expiration date Verify that this has not been exceded before use The date can be checked on the Use Until label attached to the ECG cable HeartSine Technologies Inc Page 27 samaritan AED User Manual 6 8 Data Pak Rechargeable Battery and Charger Instructions SBP 002 SBP 010 co Read these instructions before charging and using the SBP 002 Data Pak battery or SBP 010 Charger Note The SBP 002 Data Pak battery is only compat
29. f each defibrillator it manufactures This regulation further requires that each purchaser or owner of a defibrillator notify the manufacturer if the product is lost stolen or destroyed If the defibrillator changes ownership either by donation reselling or distribution the manufacturer must be notified of the new location Notification of Adverse Events Requirements Medical Device Reporting US Incident reporting EU and Mandatory Problem Reporting Canada regulations require that HeartSine Technologies is notified of any specific adverse events involving a HeartSine Technologies product These events relate to serious reports involving death serious injury or illness of a patient and near incidents Further information can be found in U S Federal Regulations 21 CFR 803 the EU Medical Devices Directive 93 42 EEC and Canadian Medical Devices Regulations If you are unsure of what to do always HeartSine Technologies Inc Page 1 samaritan AED User Manual report any Samaritan AED malfunctions or failures to HeartSine Technologies Page 2 O HeartSine Technologies Inc User Manual Overview of this manual 2 Overview of this Manual This manual describes how to use the Samaritan AED It helps you understand the basic operation of the device and takes you through it using task driven exercises To draw your attention to certain items of importance in the manual and to help you understand instructions this guide
30. ge 51 samaritan AED User Manual 10 4 Cleaning the Device To clean the Samaritan AED wipe the Samaritan AED with a soft cloth that has been dampened in one of the following e Soapy water Isopropyl alcohol 70 solution A Do not immerse any part of the Samaritan AED in water or any type of fluid Contact with fluids may seriously damage the device or cause fire or shock hazard Do not clean the Samaritan AED with abrasive materials cleaners or solvents 10 5 Storing the Device This section provides you with the information on how to store Samaritan AED correctly Important points to remember when storing Samaritan AED are e Store the Samaritan AED in a suitable location for easy access Store the Samaritan AED a clean and dry environment e Ensure that the defibrillation pads are disconnected when not in use 10 6 Configuring the Samaritan AED There are some features of the Samaritan AED that you can configure using Saver This is the same tool that is used to retrieve information saved on the Samaritan Data Pak Battery The features that are configurable using Saver include The clock The backlight timer Therapy sequence Audio recording on or off Speaker volume LU Refer to the Saver User Manual for further information on using Saver to configure the Samaritan AED Page 52 HeartSine Technologies Inc User Manual Accessories for the Samaritan AED 11 Accessories for the S
31. gt 3 Lead cable attached FU No Data Recording Self Test Passed O HeartSine Technologies Inc Page 39 samaritan AED User Manual 7 7 Audible Instructions The Samaritan AED employs two types of audible prompts e Audible indications such as a rising tone which lets you know that the device is charging e Voice prompting such as instructions or warnings Audible Indications An audible indication is used to alert you to the occurrence of two critical events Start up when the On Off button is pressed the Samaritan AED emits a short audible tone to indicate that power has been applied Charging when the Samaritan AED is charging a continuous audible tone is emitted The pitch of the tone will rise according to the increasing voltage A fixed high pitch will indicate that the required charge level has been achieved gt The audible tone emitted during charging will continue until therapy has been applied or aborted Voice Prompts The Samaritan AED features a voice prompt facility They are accompanied by text or icon prompts in most cases Voice messages are used to provide the following types of information e Incorrect use e Progress e Instructions e Warnings A number of languages are available for the Samaritan AED Languages are programmed into the Samaritan AED by the manufacturer prior to delivery For complete list of languages contact your Authorized Heartsine Distributor Page 40 Heart
32. h only if the patient cable is not inserted in Samaritan AED correctly gt If the amber indicator is flashing the patient cable is either not connected or not correctly connected Shock Button Indicator The shock button indicator illuminates the Shock button If the shock button indicator is illuminated then the Samaritan AED is fully charged and ready to deliver therapy once the Shock button is pressed HeartSine Technologies Inc Page 33 samaritan AED User Manual 7 4 Understanding Display Information 1 Heart Rate 5 Elapsed Time 2 Data 6 Battery Level 3 CPR Timer 7 Visual Prompts 4 ECG 8 Shocks Delivered Figure7 4 Samaritan AED Display Information is shown on the LCD screen using several different means e The ECG trace e Information relating to the patient and the AED such as heart rate elapsed time the number of shocks delivered or charging status Text icon messages telling you the status of the therapy or providing instructions ECG Display The Samaritan AED displays the Electrical Activity of the Heart ECG in scrolling mode and exhibits the actual activity under analysis by the embedded software Page 34 O HeartSine Technologies Inc User Manual Understanding the Samaritan AED Interface A The Samaritan AED display is intended only for basic ECG rhythm identification The frequency response is not intended for diagnostic and ST segment interpretation O HeartSine Technologies
33. harging or after the Samaritan AED advises that it is READY TO SHOCK Lift the blue cover from above the Manual Override button so the button is accessible Press the Manual Override button Figure 6 5 Manual Override button under blue flap You will hear the following audio prompt Disarming The device returns to patient monitoring mode gt You can abort a shock whenever the AED is charging or is charged 29 If you wait for 30 seconds after Samaritan AED has first instructed you to press the Shock button the charge will be aborted O HeartSine Technologies Inc Page 21 samaritan AED User Manual 6 6 Manual Override Instructions Only Available in the Samaritan AED Advanced Model SAM 001 Manual Override The Manual Override feature is an option that is set by the manufacturer Only the Samaritan AED Advanced Model SAM 001 has the Manual Override option enabled This feature is disabled in the Samaritan AED Basic SAM 003 and Standard SAM 002 Performing a Manual Shock With the Samaritan AED Advanced SAM 001 model you can perform a manual shock if you believe that the patient requires a shock immediately without waiting for the Samaritan AED to fully analyze the patient Lift the blue cover from above the Manual Override button so the button is accessible samaritan AED You will see the red Manual Override button Press the Manual Override button Figure 6 6 Manual Override but
34. he resuscitation team e Patients lt 36kg e Patients with do not resuscitate DNR instructions e Patients whose cardiac arrest had obviously resulted from a non cardiac cause trauma drowning etc ANALYSIS Each record was interpreted by a qualified cardiologist and annotated to detail each VF VT episode and determine the success or failure of a device to terminate the arrhythmia Successful defibrillation was defined as termination of VF for gt 5 seconds or termination of other shockable Ventricular Tachyarrhythmia for gt 5 seconds Any subsequent recurrence was defined as a new episode Page 66 HeartSine Technologies Inc User Manual Appendix RESULTS Total number of patients HeartSine Samaritan AED 8 Biphasic X 23 VE Summary HeartSine Biphasic Samaritan AED Parameter Total number of episodes 28 0 100 0 62 0 100 0 Total number of successful shocks 28 0 66 7 61 0 39 4 Total number of unsuccessful shocks 14 0 33 3 94 0 60 6 Success within 1 shock 18 0 64 3 36 0 58 1 Success within 2 shocks 24 0 85 7 43 0 69 4 Success within 3 shocks 28 0 100 0 48 0 71 4 Average number of 1 5 25 shocks required Average energy required J 125 0 150 0 Average energy reduction J 25 0 16 6 SUMMARY The initial results from the Human Clinical trial suggests that the HeartSine SCOPE biphasic waveform is at least as effective as the other marketed constant energy biph
35. heart arrhythmias the AED delivery system is charged and the operator will be advised to shock the patient by pressing the illuminated Shock button The Samaritan AED provides the operator with audio and visual prompts These prompts e Instruct the operator on the next step when using the device e Signals to the operator the current activity of the AED e Warns of any problems that have occurred e Advises on safety requirements All events during the monitoring and delivery of the defibrillation therapy are recorded and stored by the AED in the Samaritan Data Pak Battery and can be reviewed later using a PC Refer to the Saver User s Manual for further information on reviewing details of therapy stored in the Samaritan Data Pak Battery O HeartSine Technologies Inc Page 45 samaritan AED User Manual What is Biphasic A biphasic shock involves an electrical current being passed through the heart initially in one direction then in another in order to restart the heart Therapy must not only deliver energy but also discharge it ina controlled and clinically effective manner Extensive research and clinical trials have led to the recognition of the biphasic shock as the best definitive therapy for treating victims of cardiac arrest A biphasic shock has been found to be as effective as higher energy monophasic shocks HeartSine has developed the Samaritan SCOPE biphasic technology The Self Compensating Output Pulse Enve
36. ible with Samaritan AED revision 1 0 24 software or higher The SBP 010 charger is intended only for charging HeartSine Technologies SBP 002 Data Pak rechargeable batteries Instructions for Use 1 Review the SBP 002 Data Pak Instructions for Charging and Use and the SBP 010 Charger s User Manual before charging or using the SBP 002 Data Pak Prior to using the SBP 002 Data Pak battery charge completely Recharge the SBP 002 Data Pak battery in accordance with the Instructions for Charging and Use provided with the battery Page 28 O HeartSine Technologies Inc User Manual Using the Samaritan AED Caution Use only the SBP 010 charger supplied by HeartSine Technologies to charge Data Pak SBP 002 battery Use of any other charger may cause battery damage or malfunction of the Samaritan AED and will nullify the warranty Ensure that the nine 9 contact terminals on the SBP 002 battery are clean shiny and free from corrosion or deep scratches Do not attempt to use or charge the Data Pak SBP 002 battery if charger or battery appears damaged or if battery s charger jack or any charger connections appear loose Only charge the Data Pak SBP 002 battery in a dry environment Do not use the Data Pak SBP 002 battery if it exhibits an unexpectedly short life after a full charge Do not attempt to disassemble or service the Data Pak SBP 002 battery Additional Cautions and Warnings are listed in the Data
37. ice must be maintained and cleaned as advised To properly maintain the Samaritan AED you must carry out regular checks e After each use e Daily e Monthly The following sections include information on what is required for these checks as well as cleaning and storage information HeartSine Technologies Inc Page 49 samaritan AED User Manual 10 1 Checking After Each Use The following procedure should be followed each time the AED is used 1 4 Remove the Samaritan Data Pak Battery from Samaritan and use Saver to download any stored information Re install the Samaritan Data Pak Battery in Samaritan Check the Status Indicator If the Status Indicator is blank Samaritan AED is ready to use If the Status Indicator displays a static or flashing Exclamation mark Remove the battery pack and configure it for full self test via Saver Refer to Saver User Manual for information on configuring Samaritan AED for a 10 Page 50 full self test Re install the battery and press the On Off button on the samartian AED to run the self test If the Status Indicator is blank after the self test the Samaritan AED is ready to use If the self test fails repeat step 2 If the new self test fails contact HeartSine Technologies for technical support Check supplies accessories and spares for damage or expiration replace immediately if any damage or expiration is found Check the exterior of the Samari
38. ine Technologies Inc Page 41 samaritan AED User Manual 8 2 Events Log The Samaritan AED recording system can record events that take place during the therapy session The time and date is stored with each event The types of events that can be recorded are Buttons or keys pressed Mode changes Power up Monitoring Charging Therapy delivery Charge disarm Manual Override Self test Shut down Error codes the error code associated with any visual or audio error messages 8 3 Audio Recording The Samaritan AED can record all audio activity that takes place within 5 feet 1 5 metres of the unit This includes the messages emitted by the Samaritan AED as well as speech from anyone in attendance A The Samaritan AED has the capacity to record 60 minutes of audio Once this limit is reached the Samaritan AED will stop recording audio 8 4 Other Information Recorded Other information specific to the particular Samaritan AED and Samaritan Data Pak battery is recorded for reference The types of specific information stored are Time Date AED serial number Operating software revision number Battery consumption Page 42 O HeartSine Technologies Inc User Manual Understanding How the Samaritan AED Works 9 Understanding How the Samaritan AED Works This chapter contains the following sub sections What is the Samaritan AED What does a Samaritan AED do What is heart rhythm How does a Samaritan AED wor
39. ion is always equivalent to the second phase T3 duration The interphase pause is always a constant 0 4 msec for all patient impedances The specific SCOPE waveform characteristics for a 100 J pulse are listed below Tilt 57 4 3 39 3 3 5 0 34 8 40 1 6 7 ds 120 384 7 7 150 190 205 1420 38 2 11 5 11 5 O HeartSine Technologies Inc Page 61 samaritan AED User Manual ECG Analysis Detection System Description The HeartSine Samaritan AED ECG Analysis Detection System has been designed to provide a Shock Advised decision for the following ECG Arrhythmias e Ventricular Fibrillation consisting of peak to peak amplitude of 150 uV e Ventricular Tachycardia consisting of a heart rate 180 BPM and a QRS duration equivalent to gt 0 16 seconds The HeartSine Samaritan AED ECG Analysis Detection System has been designed to provide a No Shock Advised decision for ECG Arrhythmias consisting of but not limited to e Normal Sinus Rhythm NSR e Supraventricular Tachycardia SVT e Bradycardia e Pulse less Electrical Activity PEA The HeartSine Samaritan AED ECG Analysis Detection System analyzes 5 seconds segments of the patients ECG Should 2 of 3 five seconds contiguous segments of the patients ECG meet the shockable rhythm criteria then the HeartSine Samaritan AED shall provide a SHOCK ADVISED audible and visual prompts Should 2 of 3 five seconds contiguou
40. irements Page 68 HeartSine Technologies Inc User Manual Glossary SCOPE SCOPE stands for Self Compensating Output Pulse Envelope waveform This is the biphasic technology developed by HeartSine that is incorporated into Samaritan AED Sinus Rhythm Sinus Rhythm is the normal electrical rhythm by which the heart muscle contracts and expands to create blood flow around the body Self test A Self test is a semi automatic test that is used to check that Samaritan AED is working correctly Ventricular Fibrillation Ventricular Fibrillation is a life threatening heart rhythm that is treatable with the therapy using Samaritan AED HeartSine Technologies Inc Page 69 World Headquarters HeartSine Technologies Inc 105 Terry Drive Newtown PA 18940 United States of America Toll Free 1 866 HRTSINE 1 866 478 7463 Tel 1 215 860 8100 Fax 1 215 860 8192 Manufactured by HeartSine Technologies Ltd Canberra House 203 Airport Road West Belfast BT3 9ED Northern Ireland Tel 44 0 28 9093 9400 Fax 44 0 28 9093 9401 H011 001 011 9 En
41. k How is impedance measured 9 1 What is the Samaritan AED The Samaritan AED is a semi automatic device used for the delivery of external defibrillation therapy to resuscitate victims of sudden cardiac arrest SCA who are unresponsive to stimulus are not breathing or have no detectable pulse A In accordance with the regulations of the American Heart Association and the European Resuscitation Council the Samaritan AED should not be used on children under 8 years of age 9 2 What does a Samaritan AED do A Samaritan AED provides the rapid application of defibrillation therapy the only definitive treatment for potentially fatal heart arrhythmias When the disposable defibrillation electrodes are properly applied to the patient s chest and a Samaritan AED is used the device e Monitors heart rhythm e Advises whether or not therapy should be applied by providing audio and visual instructions e Delivers therapy using a carefully defined electrical shock designed to stop the chaotic electrical activity experienced within the heart muscle during SCA and return the heart to a normal rhythm HeartSine Technologies Inc Page 43 samaritan AED User Manual 9 3 What is Heart Rhythm The normal electrical rhythm by which the heart muscle contracts and expands to create blood flow around the body is known as Sinus Rhythm When an individual suffers a sudden cardiac arrest SCA the heart may lose this rhythm and cease pum
42. l 35 No 3 2002 In addition a Human Clinical Trial has been conducted comparing the SCOPE biphasic waveform to a currently marketed constant energy biphasic defibrillator Biphasic X Results from this study are submitted below PURPOSE To establish the efficacy of conversion of VF VT at low energies with a new biphasic waveform by demonstrating that the HeartSine Samaritan SCOPE is at least equivalent to another clinically marketed constant energy biphasic system Biphasic X METHODS Standard disposable defibrillator pads were used by both devices The shock protocol used by the arrest team followed the hospital standard of care 150J shocks for the 1st 2nd and 3rd shocks on each VF VT episode The Samaritan AED was used to deliver the 1st shock energy of 100J followed by 150J and then 200 for the 2nd and 3rd shocks respectively Any shocks delivered after these first three shocks were at the discretion of the attending physician for either device CPR proceeded as per UK Resuscitation Council Guidelines HeartSine Technologies Inc Page 65 samaritan AED User Manual DATA COLLECTION The two devices to be compared were utilized on alternate days The responding team arrived at each arrest with the defibrillator appropriate to the day of attendance Inclusions e Known or suspected cardiac arrest patients Exclusions e Any patient who had already received a thoracic shock therapy prior to t
43. lope Waveform is incorporated in the Samaritan AED and delivers maximum effective therapy while minimizing any damage that could be caused by excess current SCOPE is able to do this by adjusting the biphasic energy waveform in terms of e Slope e Amplitude e Width The above manipulation is based on a patient s impedance and provides the most effective defibrillation for the specific patient Performing Cardiopulmonary Resuscitation CPR on a patient connected to a Samaritan AED may interfere with ECG monitoring The Samaritan AED will automatically pause for 60 seconds after each set of 3 shocks to allow for CPR to be performed without affecting the ECG analysis After the pause for CPR the Samaritan AED will resume ECG rhythm analysis The Samaritan AED will provide an audio prompt to Stop CPR at the completion of the pause for CPR Page 46 HeartSine Technologies Inc User Manual Understanding How the Samaritan AED Works Escalating Energy Protocol The Samaritan AED incorporates an escalating energy protocol This is utilized by e An initial shock delivered at 100 Joules e Heart rhythm analysis indicates if further therapy is advised subsequent two shocks may be delivered at 150 and 200 Joules respectively e CPR will be advised if three unsuccessful shocks have been delivered e Heart rhythm analysis indicates if further therapy is advised f further therapy is required the AED will continue at 200
44. n in bold sans serif lettering with initial capital letters for example Press the On Off button once to switch on Samaritan AED Page 4 HeartSine Technologies Inc User Manual Overview of this manual 3 Warnings amp Cautions 3 1 Electromagnetic Interference Precaution The Samaritan AED has successfully passed stringent irradiated interference tests however devices such as cellular phones and two way radios may cause the Samaritan AED to operate erroneously due to radio frequency interference RFI Operation of a Samaritan AED may also adversely affect other susceptible equipment A To safeguard against interference you must operate Samaritan AED at least 2 meters 6 feet away from all RF devices and other susceptible equipment Alternatively switch off the equipment affected by or causing the Electromagnetic Interference 3 2 Temperature and Humidity Constraints Successful operation and storage of the Samaritan AED is restricted by important environmental factors Operating during operation of the AED temperature must be between 0 C to 50 C with relative humidity non condensing between 5 to 95 Storage amp Transport during storage of the AED temperature must be between 10 C to 60 C with relative humidity including condensation between 10 to 100 HeartSine Technologies Inc Page 5 samaritan AED User Manual 4 Quick Overview This chapter provides you with essential information a
45. nergy select charge graph test message prompts data recording status icon Indicators Low battery at least 10 discharges remaining audible tone alerts user of electrode disconnect electrode connector LED service icon shows if self tests fail no battery or when service required Voice and Text Icon prompts Extensive voice and text icon prompts guide the user through the operation sequence Languages English and other languages contact your local distributor or HeartSine Technologies for information ENVIRONMENTAL Operating Temperature 0 to 50 C 32 to 122 F Storage Temperature 10 to 60 C Relative Humidity 5 to 95 non condensing Water Resistance IEC 60529 EN 60529 44 Altitude 0 4 575 meters 0 to 15 000 feet Shock MIL STD 810F Method 516 5 Procedure 40G s Vibration MIL STD 810F Method 514 5 Category 4 Truck Transportation US Highways Category 7 Aircraft Jet 737 amp General Aviation Exposure EMC EN 60601 1 2 2001 Second Edition Radiated Emissions EN55011 1991 Class B Electrostatic Discharge Immunity EN61000 4 2 1995 8KV RF Immunity EN61000 4 3 1996 80 MHz 2 5 GHz 10V m Magnetic Field Immunity EN61000 4 8 1994 3 A m Aircraft RTCA DO 1600 1997 Section 21 Category HeartSine Technologies Inc Page 59 samaritan AED User Manual EVENT DOCUMENTATION Type Samaritan Data Pak Battery with memory Memory Capacity 12 hours of ECG full disclosu
46. ping This results in a life threatening but shockable rhythm Ventricular Fibrillation VF An electrical shock can be administered to re establish normal sinus rhythm A Shock therapy should be used only when appropriate Therapy can result in injury or death to the patient if delivered when it is not required The Samaritan AED embeds cardiac rhythm software This software has been developed through many years of research into the accurate detection and identification of Ventricular Fibrillation The device is therefore highly reliable in advising you when to deliver a shock Page 44 HeartSine Technologies Inc User Manual Understanding How the Samaritan AED Works 9 4 How Does the Samaritan AED Work HeartSine and Academia have spent several years researching the analysis of heart rhythms to identify the optimal technique of applying the lowest possible amount of electrical energy in order to resuscitate a victim of SCA The Samaritan AED incorporates an advanced cardiac rhythm detection algorithm and the patented SCOPE biphasic energy delivery system This ensures a high degree of defibrillation efficacy and patient safety The Samaritan AED works as follows e The electrical rhythm of the heart is monitored via disposable defibrillation electrodes and displayed on a large LCD screen e The AED automatically analyzes the heart rhythm If the AED decides the heart rhythm is one of a number of potentially fatal
47. poor If the impedance is too low the pads are touching each other e Itis used to adjust the Biphasic Waveform parameters to ensure optimum efficacy of the therapy When Samaritan AED is switched on The patient pad impedance is measured and Samaritan AED determines if the pads are correctly connected to the patient If a problem is found Samaritan AED will alert the operator and further use of the defibrillator will be disabled until the problem is corrected gt Measurement of the impedance level is continuous Therapy cannot be delivered if proper connection between the pads and patient is lost at any stage The impedance value is used to determine some of the primary parameters of the waveform of the energy that is delivered in order to customize the delivery pattern to the requirements of the individual patient Page 48 HeartSine Technologies Inc User Manual Maintaining the Samaritan AED 10 Maintaining the Samaritan AED This chapter contains the following sub sections Checking after each use Daily checks to perform Monthly checks to perform Cleaning the device Storing the device Configuring Samaritan AED It is imperative that you maintain the Samaritan AED correctly to ensure that you can rely on the device in times of an emergency The Samaritan AED automatically performs self checks weekly to verify the readiness of the unit A Improper maintenance may damage the Samaritan AED or cause malfunction The dev
48. presents particularly important items in a stylized way Conventions are used for the following Notes and Hints Warnings References to Other Sources of Information Lists of instructions Buttons 2 1 Notes and Hints Points worthy of note or those that provide you with a hint are shown in italic lettering with a pencil symbol to bring them to your attention for example 29 The Samaritan AED is designed to be stored with Samaritan Data Pak battery installed 2 2 Warnings Warnings are shown in bold lettering with a symbol of a red triangle and exclamation mark to bring them to your attention for example A If the Status Indicator displays a flashing or solid red exclamation mark a problem has been detected HeartSine Technologies Inc Page 3 samaritan AED User Manual 2 3 References to Other Sources of Information References to other sources of information are shown in sans serif lettering with a book symbol to bring them to your attention for example Refer to the Saver User Manual for further information on reviewing details of therapy stored in the Samaritan Data Pak Battery 2 4 Lists of Instructions Instructions that you must follow in a sequential order are shown a numbered list for example 1 Press the On Off button once to switch on Samaritan AED 2 Insert the connector into the socket beside the flashing light at the top of Samaritan AED 2 5 Buttons Device buttons are show
49. re and event incident recording Up to 60 minutes audio recording Playback Capabilities Samaritan AED Data Recovery Unit and SAVER windows based data review software DATA PAK BATTERY PACK Type Lithium Manganese Dioxide LiMnO2 21V 1 4 Amp Hrs Capacity 120 shocks at 200J or 12 hours of continuous monitoring with backlight on typical Shelf Life 5 years 2 years standby life Weight 0 2kg 0 44 Ibs SAMARITAN AED DEFIBRILLATION ELECTRODES Electrodes Samaritan AED disposable defibrillation electrodes are supplied as standard with each device Standard placement anterior lateral Active Gel Area 120 cm Cable Length 100 7 cm 3 5 ft Shelf Life 2 years A Specifications and performance may be subject to change without notice Page 60 O HeartSine Technologies Inc User Manual Appendix SCOPE Biphasic Waveform Specifications The HeartSine Samaritan AED delivers a Self Compensating Output Pulse Envelope SCOPE biphasic waveform This waveform automatically optimizes the waveform pulse envelope amplitude slope and duration for a wide range of patient impedances from 25 ohms to 190 ohms The delivered waveform to the patient is an optimized impedance compensated biphasic truncated exponential waveform which incorporates an escalating energy protocol of 100 J 150 J 200 J The duration of each phase is automatically adjusted to compensate for varying patient impedances The first phase T1 durat
50. s segments of the patient s ECG meet the non shockable rhythm criteria then the HeartSine Samaritan AED shall provide a NO SHOCK ADVISED audible and visual prompts Even after a SHOCK ADVISED decision is rendered the Samaritan AED ECG Analysis Detection System continuously assesses the patient s ECG if the patient s heart rhythm spontaneously returns to a non shockable rhythm the Samaritan AED will automatically disarm the defibrillator and advise the operator Page 62 HeartSine Technologies Inc User Manual Appendix D ECG Arrhythmia Analysis Algorithm Performance The HeartSine Samaritan AED ECG Arrhythmia Analysis Algorithm Performance has been extensively evaluated by using the American Heart Association s AHA Database and the Massachusetts Institute of Technology MIT NST database The HeartSine Samaritan AED ECG Arrhythmia Analysis Algorithm Sensitivity and Specificity meets the AAMI DF39a requirements and AHAb recommendations The HeartSine Samaritan AED ECG Arrhythmia Analysis Algorithm performance is summarized in the table below Rhythm Class x SUE ample Size Shockable Rhythm Ventricular Fibrillation VF and Ventricular Tachycardia VT Non Shockable Rhythm Normal Sinus Rhythm NSR Non Shockable Rhythm Asystole Non Shockable Rhythm All other Rhythms No error to measure Performance Specifications Sensitivity gt 90 VF Sensitivity gt 75 VT Sp
51. s working correctly ECG trace along the upper portion of the LCD display Time elapsed since Samaritan AED was switched on in the lower right of the LCD display 5 The battery life remaining in the Samaritan AED Battery Pack in the bottom right of the LCD display 6 Amessage confirming the current status of the therapy at the bottom of the LCD display This will either be text or Icons 7 The number of shocks that have been delivered during the therapy so far is displayed in the bottom left of the LCD display Page 18 HeartSine Technologies Inc User Manual Using the Samaritan AED Keep the patient still during ECG analysis You will be prompted as to how to proceed by audio and visual prompts A You must ensure the patient is kept still and that no one is in contact with the patient during analysis and therapy Moving the patient can lead to incorrect or delayed diagnosis A The Samaritan AED display is intended only for basic ECG rhythm identification The frequency response is not intended for diagnostic and ST segment interpretation If a defibrillation shock is required on the first application to the patient Samaritan AED will prepare for shock delivery by automatically charging the energy delivery system You will hear the audio prompt Analyzing do not touch the patient After a 3 second delay you will hear a rising tone and the Stand Clear visual prompt will be displayed on the LCD You will then he
52. sfully understand and interpret the Samaritan AED interface Page 30 HeartSine Technologies Inc User Manual Understanding the Samaritan AED Interface 7 1 Altering the Contrast Backlight Contrast Figure 7 2 You may wish to alter the contrast of the LCD screen if you cannot see the screen properly To alter the contrast of the LCD screen e Press the Contrast button to increase the contrast to the maximum each press will intensify the contrast of the LCD display gt When the maximum contrast has been reached the next time you press the Contrast button the display will return to the minimum contrast gt The Contrast and Backlight buttons will not operate during the actual delivery of the therapy 7 2 Turning off the Backlight You may wish to turn off the backlight of the LCD screen if you cannot see the screen properly or if you want to ensure that the battery lasts longer 2S default the backlight is turned on To alter the backlight of the LCD screen Press the Backlight button once to turn the backlight off HeartSine Technologies Inc Page 31 samaritan AED User Manual Press the Backlight button again to turn the backlight on You can configure a timer for the backlight using Saver This feature allows you to specify the length of time the backlight should remain on while the device is powered on LU Refer to the Saver User Manual for information on how to set the backlight timer
53. sure pads are completely adhered to skin Page 16 HeartSine Technologies Inc User Manual Using the Samaritan AED Figure 6 2 Proper Pad Placement A The defibrillation pads must not touch each other This can cause electrical arcing and possible skin burns and may divert defibrillating energy away from the heart Insert the connector into the socket beside the flashing light at the top of Samaritan AED as in Figure 6 3 flashing light indicates the socket location Figure 6 3 Plugged in Pad Connector Once the connector is firmly seated the Samaritan AED will automatically begin to analyze the patient You will hear the audio prompt Analyzing Do not touch the patient O HeartSine Technologies Inc Page 17 samaritan AED User Manual If the pads are not correctly attached to the patient you will hear the audio prompts Check pads and pads connector Apply pads to patient s bare chest Plug in pads connector next to flashing light If the pads are correctly connected you will see the following LCD display Figure 6 4 Samaritan AED in Stand Clear mode This display provides the following details of the patient s condition and about the therapy 1 Heartrate BPM in the top left of the LCD display 2 4 or Z symbol in the top right of the LCD display indicating whether the communication between the AED and the Samaritan Data Pak Battery i
54. tan AED and the connector sockets for cracks or other signs of damage contact HeartSine Technologies if any damage is found Check the exterior of the Samaritan AED and the connector sockets for dirt or contamination clean Samaritan if dirt or contamination is found Ensure that the defibrillation pads are disconnected when not in use HeartSine Technologies Inc User Manual Maintaining the Samaritan AED 10 2 Daily Checks to Perform The following checks should be performed daily Check the Status Indicator If the Status Indicator is blank Samaritan AED is ready to use If the Status Indicator box displays a static or flashing Exclamation mark 1 Remove the battery pack and configure it for full self test via Saver 2 Reinstall the battery to run the self test If the Status Indicator is blank after the self test Samaritan AED is ready to use If the self test fails repeat step 2 If the new self test fails contact HeartSine Technologies for technical support 10 3 Monthly Checks to Perform The following checks should be performed monthly e Check supplies accessories and spares for damage or expiration replace immediately if any damage or expiration is found e Check the exterior of the Samaritan AED and the connector sockets for cracks dirt or other signs of damage Clean the Samaritan AED if dirty or contaminated Contact HeartSine Technologies if any damage is found HeartSine Technologies Inc Pa
55. that you should follow to ensure that they are ready to receive therapy 6 1 Useful Hints Don t worry The Samaritan AED will provide audio and visual text prompts to guide the rescuer through the resuscitation process The Samaritan AED will automatically pause for CPR to allow the rescuer to administer Cardiopulmonary Resuscitation CPR after each set of 3 shocks Good contact between the electrodes and the patient is essential A Delivering a shock to a patient that is not adequately prepared can have fatal consequences or may cause the therapy to be unsuccessful Page 14 HeartSine Technologies Inc User Manual Using the Samaritan AED 6 2 Quick Instructions Every Samaritan AED in a carry case comes with a Quick Instruction guide that should be placed with the device at all times This is an easy to follow quick reference card to help rescuers during an emergency The HeartSine Samaritan AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs e Unconscious e Not Breathing e Without Circulation no pulse 1 Turn on AED Press and release the On Off button to switch on the AED 2 Follow Prompts Voice and visual instructions will instruct you to Apply pads to patients bare chest Plug in connector next to flashing light If directed administer therapy by pressing the Shock key samaritan AED Quick Instruction Guide Use samaritan AED when patient
56. ton under blue flap After you press the Manual Override button you will hear the following audio prompt Manual Override Selected The display will indicate manual mode selected Page 22 HeartSine Technologies Inc User Manual Using the Samaritan AED Press the Manual Override button again within 5 seconds to select an energy delivery level You can select an energy delivery level by pressing the Manual Override button 1 2 3 or 4 times in quick successions depending on the energy level required Pressing the Manual Override button a fifth time will resume automated operation In the Manual Override mode you may select one of four energy delivery levels These energy levels are 1 100 Joules 2 150 Joules 3 200 Joules 4 230 Joules With each press of the manual override button the text or Icon display will indicate the selected energy For Text Displays For Icons Displays CHARGE TO 100 J CHARGE TO 150 J 2150 200 J 2200 230 J 2230 gt 200 is not selectable for a patient with an impedance of lt 250 230J is not selectable for patients with an impedance of lt 30Q HeartSine Technologies Inc Page 23 samaritan AED User Manual After selecting an energy level the Samaritan AED will charge and you will hear a rising tone along with the following audio prompt Do not touch the patient The Shock button illuminates when the charging cycle is
57. ysis system to render a shock decision This chapter provides you with the information that you will require to operate the Manual Override function of Samaritan AED Advanced Model A Only authorized advanced users trained in cardiac rhythm recognition and the use of manual charge and shock defibrillation therapy should use the Manual Override feature These advanced users should be certified in Advanced Life Support ALS Page 24 O HeartSine Technologies Inc User Manual Using the Samaritan AED 6 7 ECG Monitoring Cable User Instructions The samaritan AED ECG monitoring Cable can be used on any samaritan AED with 1 0 19 software or higher 29 Only SAM 001 and SAM 002 will display trace Heart Rate SAM 003 devices will only have voice prompts in relation to the patient reading CAUTION As with other ECG monitoring devices the use of monitoring only electrodes are susceptible to excessive ECG signal artifact This artifact can cause inaccurate AED rhythm analysis decisions Itis imperative that the user performs proper skin preparations placement and use of fresh high quality monitoring wet gel electrodes to minimize artifact Should the AED advise to Apply Pads while using the ECG cable adaptor attach the defibrillation electrodes to the patient and follow the AED voice prompts SAC 009 AAMI SAC 010 IEC ECG monitoring ECG monitoring Mutti Clip cable cable

User Manual - AED Superstore

Contents

Download Pdf Manuals

Related Search

Related Contents