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1. Le Menu Keys MODE ENERGY Selector Knob ANALYZE CHARGE Button SHOCK Button The paramedic CU ER2 20 Freedom of Choice In manual mode the Paramedic CU ER2 has to be operated by personnel trained in advance cardiac life Support The operator should have the skill to interpret ECG rhythms In this mode the operator has the freedom to set the energy level of the defibrillating shock The choices are in Joules 2 3 5 7 10 20 30 50 70 100 150 200 R Wave Synchronization The Paramedic CU ER2 has the capability to synchronize the shock delivery with the R Wave of the patient s ECG Highly portable The Paramedic CU ER2 weighs only approximately 2 8 kg It comes with an optional Carrying Case that could contain all the necessary devices and accessories needed for a rescue operation Versatile Power Supply The Paramedic CU ER2 is equipped with a rechargeable Nickel Metal Hydride battery pack as a standard component The battery may be recharged through an AC adapter standard accessory or through a car cigar lighter jack power cord optional The battery has a capacity of 200 shocks 150 Joules each when new and fully charged Battery Compartment SmartMedia Card Port Cover AC DC Adapter Port IrDA Port UART Port Side view of the paramedic CU ER1 Rescue Data Storage The data collected during a rescue operation is stored in the internal flash memory or the optional external SmartM
2. open Power on Remove ofthe clothes 2 Open the disposable pads Open pads Take the pads Plug of the connector of the pads Main Rescue Seguence 1 Attach pads on patient then connect to AED Peel off Attach pads 2 Press the SHOCK button if instructed Press button as directed by Voice prompt Y P pu Press button 3 Perform CPR The NF1200 directs you to do CPR after delivering one shock Indicators and Voice Prompts Graphical Rescue Guide lights up the third step of the rescue operation For other indicators and voice prompts see CPR Protocol The CPR protocol depends on the following settings Rescue Provider Lay Rescuer Healthcare Provider 7 2 Compression Ventilation Ratio 30 2 30 compressions 2 breaths 15 2 15 compressions 2 breaths CU ER1 Single Mode AED AC Adapter Input 100 240V AC 50 60Hz 1 2A Output 12V DC 3 5A Size 305mm X 250mm X 95mm LX W X H Weight Approximately 2 7 Kg Screen Size 320 x 240 Graphic LCD Galvanic Protection BF Type Self Test Periodic test daily weekly monthly Waveform TC ube Biphasic Technology Energy 150J into a 50Q load default setting The Paramedic CU ER1 is a semi automated external defibrillator designed to deliver a defibrillating shock to victims of sudden cardiac arrest It is designed for easy use and high portability Easy to Use The Paramedic C
3. i E i td Chi Freg es H2 Mo period found Chi pk pk 2 al V alka Tii ii LEIS Ma ooms ii 11 47 20ms 16 Jun 2004 17 08 27 Phase A Duration Phase B Duration Energy Delivered milliseconds milliseconds Joules ECG Analysis System Category Nominal Specifications mi Determines the impedance of the patient and evaluates the ECG of the patient to determine whether it is shockable or non shockable Impedance Range 450 to 1109 Function Shockable Rhythms Ventricular Fibrillation or Fast Ventricular Tachycardia ECG rhythms other than Ventricular Fibrillation or Fast Ventricular Tachycardia Sensitivity amp Specificity Meets AAMI DF39 guidelines Display Auto scaled 0 3 to 1 mV signals are displayed with 10mm mV gain Sensitivity outside of that range the peak to peak value is displayed as 10 mm on the LCD display Heart Rate Display Limits 30 bpm to 300 bpm beats per minute Controls Indicators and Prompts Category Nominal Specifications High resolution 320X240 pixels backlighted liquid crystal display screen Non Shockable Rhythms LCD Screen ON OFF button Controls SHOCK button Menu Keypad buttons F2 Self Tests Power On Self Test Run Time Self Test it daily weekly monthly User Initiated Manual Self test Battery AC DC Adapter Category Nominal Specifications Power Supply 100V to 240V AC 50 to 60Hz Output 12V D
4. f Heart Rate d d Shock Count Alarm Status KA Fi Indicator Energy i f f Y f f SPO Value 4 4 Y EE AN __ ENERGY kr 10 ndicator sh 150J I ay Poon Roue Contact Quality Defibrillation 4 Indicator Delivery i Indicator d ECG Display ECG Lead ti PCG Lead F i Text Prompt Indicator jll Check Pads Disconnected Cable i i Battery Level b ee Elapsei indicator 00 00 15 Time T A AN Key Labels Rescue Data Storage The data collected during a rescue operation is stored in the internal flash memory or the optional external SmartMedia Card When the SmartMedia card is used the option to record audio signals during a rescue operation may be turned ON not available when recording in internal flash memory The data can be downloaded to a personal computer using the CU EX1 data management software for archiving review and printing KA CU HD1 Defb amp Monitor Display TFT Colour LCD 7 inch diagonal 152 X 91mm Resolution 800 X 480 pixels Defibrillation Defib Common e Waveform Truncated Exponential Biphasic E cube e Battery Less than 7 seconds to 200 Joules e Charge time Adapter Less than 5 seconds to 200 Joules AED Mode e Shock Delivery Via multifunction defib electrode pads e Output Enegy 200 Joules Manual Mode e Output Energy 1 10J 15J 20 30 50 100J 120J selected 150 170J 200 e Shock Delivery External paddle with paediatric
5. 140mm X 85mm Weight 890g Standard Accessories User s Manual Defibrillator connector 9V Battery DATA MANAGEMENT S W CU EX1 Expert of Data Management Software The CU EX1 is The Company s data management software intended to facilitate the handling of data recorded during a rescue operation The software has three main functions These are a archiving b data review and c data printing Archiving The CU Expert manages the downloading of ECG and Rescue Data from devices manufactured by The Company The supported devices are Paramedic CU ER1 Paramedic CU ER2 and Cardio meter CU PH1 The CU Expert enables the user to enter patient information Name Age Sex and Address after downloading Review The ECG and Rescue Data that have been archived on a personal computer can be opened for review using the CU Expert ECG and Rescue Data Management Software The software can be set for ECG data review using any of the three available ECG gains These are 5 mm mV 10 mm mV and 20 mm mV The review is easily controlled through control buttons PLAY PAUSE STOP BACKWARD FAST FORWARD The CU Expert also allows the user to jump to a particular Rescue Event Highlight during ECG review 7CU Expert 210 x Be Yow Tool Help KAHEKS 17 55 09 Analyzing 17 55 13 No Shock Ad 6 17 55 06 Analyzing a Summary 17 55 09 Shock Advise Grid size is 2seconds x ASmV 17 56 17 Armed 17 55 19 Shock 1 17 55 25 Analyz
6. ECG database of The Company The detection tests measure the Sensitivity and Specificity of the Arrhythmia Detector Algorithm Sensitivity is a measure of the capability of the algorithm to correctly identify shockable rhythms while Specificity is a measure of the algorithm s capability to correctly identify nonshockable rhythms E The tests using the databases show the following results Sensitivity Specificity The detector continuously monitors the ECG of the patient as long as the defibrillation pads are connected to the patient If a patient s ECG changes from shockable to nonshockable after the AED has charged its defibrillating capacitor the shock delivery is aborted and the charge is dumped on the internal dump resistance of the AED REFERENCES The Company is committed to its mission of providing public access life saving devices The company s thrusts are 1 To provide a complete rescue solution and 2 To incorporate high end features at highly competitive prices Alongside with its defibrillators The Company offers a patient simulator for training purposes and a data management software for the archiving review and printing of rescue data Its defibrillators are equipped with features found in more expensive defibrillators from other companies The AED from The Company features voice and text prompts that guide the user throughout the rescue operation Rescue operation data is stored in the internal or in the optiona
7. Internal paddle e Synchronous Cardioversion Printer e Continuous ECG Strip Real time 8 seconds delay e Printing Speed 25mm s e Auto printing Recorder can be configured to print marked event charge shock and alarms e Paper 50mm width 40mm Diameter Automatic Self test e Power On self test e Run Time self test e Manual self test e Periodic self test Daily Weekly Monthly Power Sources External Battery Pack Lithium Polymer e Type 14 8V 3 1Ah Rechargeable e Output 18V 6A e Capacity When new minimum 100 shock deliveries 200J AC Power Pack oa 27 Non invasive Pacing e Waveform Monophasic Truncated Exponential e Mode Demand and Fixed Mode e Amplitude Accuracy 0 200mA 5mA e Pulse Width 20ms 1 5 e Pulse Rate 30 180PPM 1 5 e Refractory Period 340 msec 30 80ppm 240 msec 90 180ppm ECG Monitoring e Input 3 lead cable I II III 5 lead cable I II III aVR aVL aVF or V 10 lead cable I II III aVR aVL aVF or V1 V2 V3 V4 V5 V6 display view All 12 lead ECG waves display simultaneously e Lead Fault Lead fault message and dashed line display If an electrode or lea wire becomes disconnected e Heard rate display 30 300 bpm 3bpm e ECG Size 5 10 20mm mV and auitogain e Heart rate Arrhythmia Alarm HR Asystole VF VT SpO2 Pulse Oximetry e Sacturation 70 100 3 digits e Pulse Rate 20 250 bpm bpm e Perfusion 0 2 e Module Manufacturer
8. Nellcor e SpO2 Alarm Less than minimum setting rate Over than maximum setting rate Data Storage e External memory card SD Card ECG data Event Voice Accessories e External Paddle e Internal Paddle e Internal Paddle Adapter e Multifunction defib pads e 3 lead ECG Cable e 5 lead ECG Cable e 10 lead ECG cable e SpO2 finger probe e SpO2 extension cable e Bed hanger e Carrying case e Cart bracket CARDIOMETER CU PH1 ECG MONITOR The Cardio Meter CU PH1 is the highly portable three lead ECG monitor from The Company CU PH1 Top View E Power indicator N Power switch 3 Alarm LED 4 LCD display 5 Left arrow button 23 i a k Green LED lit when the device is ON Used to turn the device ON or OFF Red LED flashes when the device detects an ECG signal with beat rate that is beyond the normal range defined by the user Displays the following a ECG signal acguired from the patient b ECG signal recorded in the memory of the device c Menu d Device settings Used to scroll the menu highlight to the right or downward This button is also used to turn the ORS beeper ON or OFF PJ A Used to activate the menu 6 Menu button When the menu is activated it is used to select the highlighted menu item Used to scroll the menu highlight to the left or upward 7 Right arrow button This button is also used to change the Lead of the ECG signal being acquired Hig
9. available when recording in internal flash memory The data can be downloaded to a personal computer using the CU EX1 data management software for archiving review and printing Automated Self Tests To ensure that the Paramedic CU ER1 is always ready for a rescue operation the device is programmed to run self tests automatically the battery has to be connected and should have sufficient charge Prompts and alarms are given off if the device fails the self tests Accessories Car Cigar Lighter Jack Power Cord Defibrillation Pads assembly Power Cord AC Adapter External Rechargeable SmartMedia ECG Monitoring Thermal Printer Battery Card Cable Connector Carrying Case CU ER1 TECHNICAL SPECIFICATIONS physical Category Nominal Specifications 3 74 inches high X 9 84 inches wide X 12 inches deep 95 mm high X 250 mm wide X 305 mm deep l Environmental Category Nominal Specifications eae 32 F to 122 F 0 C to 50 C Conditions Humidity 5 to 95 non condensing Conditions Humidity 5 to 95 non condensing Shock Drop Abuse Tolerance Meets IEC 60601 1 clause 21 Mechanical Strength Meets MIL STD 810E Method 514 4 Category 10 Meets IEC 60601 1 clause 44 Overflow spillage leakage Sealing humidity ingress of liquids cleaning sterilization and disinfection Meets IEC 60601 1 2 limits method EN 55011 1998 Group 1 Level B EMI Radiated Meets IEC 60601 1 2 limits method I
10. in order to get a display of the patient s ECG rhythm Lead I II III 3 Lead ECG cable Lead I II III aVR aVL aVF or V 5 Lead ECG cable The Paramedic CU ER5 automatically records ECG and events such as shock deliveries in nonvolatile memory during rescue operations These data may be printed directly using a portable printer or downloaded to a personal computer for printing and archiving The Paramedic CU ER3 is capable of monitoring pulse oximetry SPO2 Nellcor in manual and AED modes Pulse oximetry measurement is automatically done when the pulse oximetry gt sensor is connected to the appropriate port on the device Po 7 kh i a mi a 2 SPO2 Monitoring is indicated when it is beneficial to assess a J patient s oxygen saturation level Versatile Power Supply The Paramedic CU ER5 is powered by an internal rechargeable Nickel Metal Hydride battery pack It may also be powered by an optional external disposable LiMn0 battery pack or its AC DC adapter While the internal battery is being recharged by the AC DC adapter the AC DC adapter also supplies power to the whole device which enables it to be fully functional Automated Self Tests The Paramedic CU ER5 runs automatically initiated self tests even during storage to test its readiness for rescue operations Faults during these tests are communicated to the user through prompts and alarms Heart Rate Calculation Source Indicator
11. resolution 200 samples sec 12 bits e Real time monitoring of BPM trend 2 Display e Screen Type High resolution display Graphic LCD e Screen size 4 inches 10 16 cm diagonal 320X240 pixels e Sweep speed 25mm sec nominal EN 30 e Viewing time 3 2 seconds e Backlight Can be turned ON or OFF e QRS Beeping Can be turned ON or OFF e Screen Information ECG Heart Rate Current Lead s Elapsed time Status of Battery Alarm and Recording Data Storage amp Management e Recording Time 600 minutes e Data Recording ECG Waveform Recording Time BPM Trend e Data communication IrDA 2 Safety Standards e IEC 601 1 IEC 601 2 25 MDD 93 42 EEC e Class IIa Type BF Power e 1 5V x 2 AAA LRO3 type batteries physical e Length 133 mm e Width 108 mm e Thickness 22 mm e Weight 230 g Package Contents e Device 1 ECG Cable 3 lead 2 Battery 1 5V AAA ECG Electrodes Optional Accessories Carrying Case ECG Electrodes 50EA Pack Data management software CU EX1 for patient information Multi purpose Cradle for the device CU PH2 ECG SP02 gt The i Viewer CU PH2 is a lightweight portable battery operated 5 lead Electrocardiogram ECG and SPO2 monitoring device It has a high resolution 320x240 pixels liguid crystal display LCD One ofthe leads and the plethysmographic wave is displayed simultaneously The i Viewer CU PH2 runs on four AAA size 1 5V batteries I
12. systems using monophasic devices for early defibrillation have documented better than 20 survival to hospital discharge for cardiac arrest patients found in ventricular fibrillation VF Attempts to improve this survival rate have adapted proposals to change the waveform and energy level of defibrillation shocks 6 Biphasic waveform defibrillators incorporate two way current flow in which P lt 0 0091 P lt 0 0001 P lt 0 0001 P 0 01 E Biphasic B Monophasc Percent of VF Patients X N lt Defib in 1 Defibin12 Defib in 1 3 Defib Pro ROSC Shock Shocks Shocks hospital Electrical currenat first flows in one direction then reverses the direction in opposite Extensive animal and human data with implanted devices demonstrate that biphasic waveforms offer substantial reductions in defibrillation thresholds and produce less myocardial dysfunction than monophasic waveforms 1 4 The defibrillation efficacy of the 150 J biphasic waveform was superior to that of the 200 J to 360 J conventional escalating energy monophasic waveforms for 115 patients who presented with VF 5 AA 20 g NG i Le 7 E whe i pS 2 A 20 A l E 440 2 60 E o A z L 8 i 100 200 300 40 500 GCM 700 Time ns Transmembrane potential for a single Beeler Reuter cell subject to monophasic and biphasic Each stimulus amplitude A is 17 0 mV duration is 10 ms and is applied 360 ms after the init
13. C 3 5A Operating 32 F to 104 F 0 C to 40 C Environmental Requirements Storage 22 F to 185 F 30 C to 85 C Relative Humidity 5 to 95 non condensing Conformance Testing EN 60601 1 Defibrillator Pads Category Nominal Specifications Disposable self adhesive pre gelled adult defibrillator pads Pads Cable and Connector gt Minimum area of 100cm 7 Integrated connector Data Storage and Management SmartMedia Card Memory Category Nominal Specifications Type Removable Flash Memory Card 48 hours of Event and ECG recording or Capacity 7 1 hour recording if voice recording is enabled Internal Flash Memory Type Flash Memory Capacity 7 12 hours of event and ECG recording CU ER2 Dual Mode AED The Paramedic CU ER2 has all the features of the Paramedic CU ER1 In addition a manual mode is provided for advanced users Easy to Use The Paramedic CU ER2 in automatic mode is designed to automatically analyze the ECG ofthe patient Analysis starts as soon as the ECG pads are properly attached The user is guided by a combination of text and voice prompts throughout the rescue operation The ECG of the patient is displayed in a liquid crystal display LCD Defibrillator ECG Monitoring Pads Connector Port Quick Reference Guide ON OFF Button Indicator Lamps PT ja SYNC Button PAUSE DISARM Button LCD Screen Microphone 955 Speaker
14. DEFIBRILLATORS JULY 2008 Arsiconsult 38 Av Guy de Maupassant 78400 Chatou France Tel 33 1 30 53 07 11 Email medical arsiconsult com MEDICAL PRODUCTS DEFIBRILLATORS Quality System Standard applied ISO 13485 2003 EN46001 MDD 93 42 EEC CE Certification COMPANY C 2 2 2 tect ee eee eee eee Page 3 TECHNOLOGY CUBE BIPHASIC TECHNOLOGY nee tia ta ia al dere ceded avaja ika Page 4 ARRYTHMIA DETECTION crentosa inaa a AE E altari ait ad Page 9 I PAD NF1200 mm Page 11 CU ER1 Single Mode AED 222 222 222 eee eee eee eee eee Page 14 CU ER2 Dual Mode AED 22 22 2222 eee eee ee eee ee eee eee eee eee Page 20 CU ER3 Dual Mode SpO2 2222222 eee ee eee Page 22 CU ERS Defb amp Monitor 2 2 2 eee sn Page 24 CU HD1 Defb amp Monitor 2 2 2222 eee eee Page 27 CULPHL ECE MONITOR EEE ainn ae teeta lue eee D 0 CDs die ce idee Page 29 COPALEEGISBOD LEE Se ns SA en ee Sue 2 Page 32 COMPANY SCI The Company is a high technology company involved in the design development manufacture selling and service of emergency medical devices with the latest IT technology We provide safe reliable and intelligent cardiac monitoring and defibrillation technology that significantly raises access speed to defibrillation Our mission is for our Paramedic se
15. EC 61000 4 3 1996 Level 2 EMI 1 Immunity 3V m 26MHz to 1GHz l Defibrillator Category Nominal Specifications Operating Mode Semi automated e cube Biphasic Technology Truncated exponential type impedance compensated Waveform Defibrillator continued Energy 150J and 180J nominal into a 50Q load 150J 150J 150J Preprogrammed series 150J 150J 180J 150J 180J 180J Automatic by Software Arrhythmia Detection System and Charging Control Charge Control Charge time from Shock Advised lt 10 seconds typical Shock to Shock cycle time lt 15 seconds typical including analysis 7 Text prompt CHARGING COMPLETE followed by text and voice prompts PRESS THE SHOCK BUTTON gt flashing backlight of SHOCK button 7 beep from the beeper Charge complete indicator Once charged the Paramedic CU ER1 disarms if Patient s heart rhythm changes to non shockable rhythm or The SHOCK button is not pressed within 15 seconds after the Paramedic CU ER1 is armed or The ON OFF button is pressed to turn OFF the Paramedic CU ERI or The defibrillator pads are removed from the patient or the pads connector is disconnected from the Paramedic CU ER1 Disarm Shock is delivered if the SHOCK button is pressed while the Paramedic CU ER1 is armed Shock Delivery Vector Via adult defibrillator pads in the anterior anterior Lead II position Patient Isolation Type BF Shock Delivery Tek stop E
16. Monitor Capability Space 80 MB 80 MB 80 MB 80 MB 100 MB 16 bits 16 bits 16 bits 16 bits 16 bits Color a
17. Test Mode Indicatce LED Intended use The CU SM1 is intended for cardiac rescue simulations during trainings for cardiac emergency responders The CU SM1 is not intended for the precise and accurate measurements of defibrillator outputs The measurement accuracy of the device is not guaranteed when used to measure shocks with energies less than 50 Joules For shocks with energies between 50 and 200 Joules the indicated measurement is within 10 of the true value The maximum voltage and energy that the device can handle are 2000V and 200 Joules respectively Even though the shock energy and leading edge voltage measurements are not guaranteed for defibrillation shocks with energies below 50 Joules the device may still be used in rescue simulations where the delivered shock energy is less than 50 Joules In this case the simulated ECG output of the simulator is still useful to the defibrillator The delivered shock energy measurement however has to be discarded The connector cable that is included with the device is specifically designed for the family of defibrillators from CU The Company To use the CU SM1 with defibrillators from other manufacturers ECG cables fitted with banana connectors will have to be provided by the user ECG Signal Simulation The CU SM1 can generate Normal Sinus Rhythm Ventricular Tachycardia Supraventricular Tachycardia Ventricular Fibrillation fine Ventricular Fibrillation and Asystole ECG signals T
18. U ER1 is designed to automatically analyze the ECG of the patient Analysis starts as soon as the ECG pads are properly attached The user is guided by a combination of text and voice prompts throughout the rescue operation The ECG of the patient is displayed in a liquid crystal display LCD Defibnlator ECG Monitonng Pads Connector Port ON OFF Button Indicator Lamps LCD Screen Quick Reference Guide GPI SHOCK Button Defibrillation Pads 14 Microphone Menu Keys Speaker Highly portable The Paramedic CU ER1 weighs only approximately 2 7 kg It comes with an optional Carrying Case that could contain all the necessary devices and accessories needed for a rescue operation Versatile Power Supply The Paramedic CU ER1 is eguipped with a rechargeable Nickel Metal Hydride battery pack as a standard component The battery may be recharged through an AC adapter standard accessory or through a car cigar lighter jack power cord optional The battery has a capacity of 200 shocks when new and fully charged Battery Compartment IrD Port WART Port Cover SmartMedia Card Port AC OC Adapter Port Side view of the paramedic CU ER1 Rescue Data Storage The data collected during a rescue operation is stored in the internal flash memory or the optional external SmartMedia Card When the SmartMedia card is used the option to record audio signals during a rescue operation may be turned ON not
19. actor in cardiopulmonary resuscitation in the present situation that fewer than 5 of the 250 000 persons who experience out of hospital cardiac arrest each year survive to hospital discharge How E cube Biphasic waveform Defibrillate For defibrillation to be successful a sufficient amount of electrical current must be delivered to the heart muscle How to deliver the electrical current to the heart muscle is the core technigue to defibrillate the heart Successful defibrillation would be done when the cell membranes of the heart are coated with positive ions on one side and negative ions on the other side enough to depolarize nearly 100 percent of the cardiac cells at the same instant Optimal current is determined with the pressure this means electric Voltage that controls what a amount of current can be pushed and the duration of time the current flows This defibrillation current is commonly described in joules of energy Energy is a measure of the amount of current voltage and duration of time the current flows Energy joules Current amps X Voltage volts X Time sec When the Defibrillation shock is delivered current flow is affected by transthoracic impedance the body s resistance from electrode to heart Impedance is dependent on the anatomy of the chest skin Surface air in the chest hair fat and bone as well as the size and location of the defibrillation electrodes Voltage volts Current amps Resi
20. ad III SpO2 Monitoring e Heart Rate and SpO2 Alarm System e Automatic and operator initiated self tests The Paramedic CU ERS defibrillator monitor is designed to accommodate both basic and advanced life support personnel AED Mode In AED Mode the Paramedic CU ERS analyzes the ECG of the patient to determine whether the patient has a shockable or nonshockable ECG rhythm In this mode the Paramedic CU ERS provides you with voice and text prompts throughout a rescue operation 150 Fixed Manual Mode In Manual External Defibrillation Mode the Paramedic CU ER5 lets you control the defibrillation process You assess the ECG of the patient and set the energy of the shock to be delivered You may also perform synchronous cardioversion for the treatment of a trial fibrillation in this mode In synchronous cardioversion the defibrillating shock is delivered within 60 milliseconds of the occurrence of a QRS peak in the patient s ECG In Manual Internal Defibrillation Mode the Paramedic CU ER5 operates as in the Manual External Defibrillation Mode except that the energy is limited to a maximum of 50 Joules and the shock is delivered Output Energy 1 10J 15J 20 30 50 70J 100 120J 150 170 200J ECG Monitoring Mode In Monitoring Mode the Paramedic CU ER5 acquires ECG and SPO2 signals from the patient Various alarms may be activated in this mode This mode is also used in tandem with the manual modes
21. al rescue operations as it cannot deliver a defibrillating shock ER 34 10 Standard Scenarios Scenarios Description Ventricular Fibrillation with multiple Shocks required for Conversion Ventricular Fibrillation with two shocks required for conversion Non Shockable Rhythm with two conversion Ventricular Fibrillation Shocks required for followed by refibrillation with two conversion Ventricular Fibrillation Shocks required for followed by refibrillation Ventricular Fibrillation with single shock conversion Device Error with Shock required for conversion one Ventricular Fibrillation conversion with refibrillation Ventricular Fibrillation low battery with one shock required for conversion Shockable rhythm 3 shocks 1 minute CPR time out 4th shock Non shockable rhythm Shockable rhythm 2 shocks Non shockable rhythm Non shockable rhythm throughout Shockable rhythm 2 shocks Non shockable rhythm Refibrillation shockable rhythm after 50 sec 3rd shock Non shockable rhythm Shockable rhythm 1 shocks Non shockable rhythm Refibrillation shockable rhythm after 10 sec 2rd shock Non shockable rhythm Shockable rhythm 1 shock Non shockable rhythm Shockable rhythm 1 shock Non shockable rhythm Device Error Shockable rhythm 1 shock Non shockable rhythm Refibrillation Shockable rhythm after 20 sec 2nd shock Non shockable rhythm Ventricular fibrillation t
22. an be turned ON or OFF QRS beeping Can be turned ON or OFF Screen information ECG Heart rate Current lead Elapsed time Status of battery Alarm and recording SpO2 value and Plethysmographic wave Data Storage 8 Management Recording time 600 minutes Data communication IrDA UART Safety Standard IEC 601 1 IEC 601 2 27 MDD 93 42 EEC Class Ila Type CF 1509919 Power Resource 1 5V AA type batteries 4EA AC Adapter DC 12V 3 6A TRAINER CU ERT AED Trainer The CU ERT is a defibrillator simulator designed to mimic the operations of the Paramedic CU ER1 It can simulate all the functions of the Paramedic CU ER1 including charging and shock delivery It has preprogrammed rescue scenarios that were generated in accordance with the recommended rescue protocol of international rescue policy making bodies such as the American Heart Association the European Resuscitation Council and the American Red Cross It is to be used in conjunction with the resuscitation mannequin from The Company It has a standard infrared remote control accessory which renders it operable by an instructor from a distance Intended Use The Paramedic CU ERT is intended for use during Advanced Cardiac Life Support training Basic Life Support training or any other physician approved trainings that deal with the operation of an automated external defibrillator The Paramedic CU ERT is not intended for use during actu
23. ator electrodes According to the measured patient s impedance E cube Biphasic technology adjusts the duration of current flow and voltage level of electric shock to optimize the energy to be delivered E cube Biphasic technology is consisted with 3 core technology 0 4 12 Time msec Current amps 150 Joules at 50 Ohms 1 the technology for measuring patient s impedance 2 the technology for controlling voltage level to be delivered 3 the technology for controlling duration of current flow These technologies can control dynamically what amount of energy joules for defibrillation should be delivered in spite of the variance of patient s impedance E cube Biphasic technology controls the duration of current flow to be long for the patient with high impedance than one with low impedance When escalating energy for example 150J to 200J it controls the voltage level higher if the patient s impedance is not varied 100 ohms 100 ohms More Efficient than monophasic waveform The electrical therapy delivered by transthoracic cardiac defibrillators has changed little since the introduction of direct current defibrillation more than 30 years ago Throughout this time the industry standard shock waveform for external defibrillators has been a monophasic damped sine MDS waveform in which current flows in one direction throughout the shock biphasic monophasic Many well organized emergency medical
24. d access Data Storage amp Management e Internal flash memory 12 hours of event and ECG recording e SmartMedia Card 32M 48 hours of event and ECG recording or 1 hour if voice recording is enable e Review the patient s ECG incident details and the device information e Data management software for storage review and printing of multiple patients rescue data using a PC running on Windows OS Display e Screen Type High resolution display Graphic LCD e Screen size 4 inches 10 16 cm diagonal 320X240 pixels e Sweep speed 25mm sec nominal e Viewing time 3 2 seconds physical e Size 305 mm X 250 mm X 95 mm LXWXH e Weight Approximately 1 4 kg without the external battery pack E AC Adapter e Input 100 240V AC 50 60Hz 1 2A e Output 12V DC 3 5A Battery Pack e 12V LiMnO disposable battery pack e Capacity when new 10 hours of continuous operation External Link e UART port e IrDA port 36 SIMULATOR CU SM1 The CU SM1 is a battery powered defibrillator simulator It outputs simulated ECG rhythms and receives defibrillation shocks from a defibrillator The CU SM1 also measures the energy and leading edge voltage of the shock that it receives from a defibrillator Shock Indicator LED Sternum Conmector Poet Leoo Power Indicator LED meee RG mme g A VS ra ork a A M k a y 1 A Ue D td RIGHT button Apex Connector MENU button Normal Mode indicator LED
25. d in the all patients who received treatment with 150 J biphasic shocks were eventually defibrillated during the resuscitation attempt and without resort to backup manual defibrillators which was not true for the higher energy monophasic waveforms Dynamic control of waveform parameters via impedance compensation with a 150 J biphasic shock provides consistently high defibrillation rates without the need for escalating energies 200 J to 300 J TABLE 4 Rhythms Present after Successful First Shocks Expressed as Percentages of the Number of Successes for Each Shock Type 200 200 130 Monophasic Biphasic Biphasic Rhythm n 61 n 39 n 39 Normal sinus rhythm 52 5 53 8 38 5 Sinus bradycardia 14 8 20 5 25 6 Sinus tachycardia 0 0 0 0 2 6 Supraventricular tachy cardia not sinus 11 5 5 1 5 1 Idioventricu lar 4 9 2 6 5 1 Paced 98 10 3 12 8 lunctional 1 6 5 1 77 Other 4 9 2 6 26 The firstshock efficacy of 200 J biphasic shocks is superior to both the 200 J monophasic shocks and the 130 J biphasic waveform shocks Moreover the mean peak current was almost 50 lower for the 200 J biphasic shocks than for the less efficacious 200 J monophasic shocks 6 Positive evidence for safety and clinical effectiveness of biphasic truncated exponential waveforms for internal and external use was ascertained by the AHA ECC committee 8 9 REFERENCES Chapman PD Vetter JW Souza JJ Wetherbee JN Troup PJ Comparison of monophasic with si
26. earn from customers and employees Make Continuous improvement an everyday matter Build teamwork trust and mutual respect QUALITY ASSURANCE The Company continuously encourages quality improvement through Total Quality Management to consistently improve the safety and reliability of our products as well as quality systems With these perspectives The Company strives to comply with the rigorous quality system regulations of the following organizations ISO 13485 2003 Europe with yearly inspections EN46001 Europe Medical Device Directive MDD 93 42 EEC Europe Community Europe CE MARK labelling KFDA Quality Approval Korea FDA Approval U S on processing JOA Approval Japan on processing a C CUBE BIPHASIC TECHNOLOGY What is Defibrillation Sudden cardiac arrest SCA associated with ventricular fibrillation VF remains a leading cause of unexpected death in the Western world It has been estimated that chances for survival from SCA decrease approximately 7 to 10 with each passing minute and that survival rates after 12 minutes are only 2 to 5 The most common cause of SCA is ventricular fibrillation VF a lethal heart rhythm and survival depends on the rapid treatment called de fibrillation an electrical shock sent to the heart to resume normal and healthy heart rhythm So early defibrillation is as the sole definitive determinant of survival and is the key f
27. edia Card When the SmartMedia card is used the option to record audio signals during a rescue operation may be turned ON not available when recording in internal flash memory The data can be downloaded to a personal computer using the CU EX1 data management software for archiving review and printing Automated Self Tests To ensure that the Paramedic CU ER2 is always ready for a rescue operation the device is programmed to run self tests automatically the battery has to be connected and should have sufficient charge Prompts and alarms are given off if the device fails the self tests 21 CU ER3 Dual Mode SpO2 e AED and Manual Mode Defibrillation Synchronized Cardioversion e ECG Monitoring Mode Lead III SpO2 Monitoring e Heart Rate and SpO2 Alarm System e Lightweight and highly portable Versatile power supply e Automatic and operator initiated self tests The Paramedic CU ER3 is a portable semi automated external defibrillator with the following modes of operation Automated External Defibrillation AED Mode Manual Mode AED Mode The Paramedic CU ER3 analyzes the ECG of the patient to determine whether the patient has a shockable or nonshockable ECG rhythm In this mode the Paramedic CU ER3 provides you with voice and text prompts throughout a rescue operation Manual Mode The Paramedic CU ER3 lets you control the defibrillation process You assess the ECG of the patient and set the energ
28. efibrillators Resuscitation 50 2001 61 70 ty ARRYTHMIA DETECTION Sudden Cardiac Arrest is one of the leading causes of deaths in most countries around the world Coarse Ventricular Fibrillation and Rapid Ventricular Tachycardia are the two primary heart rhythms associated with Sudden Cardiac Arrest The American Heart Association AHA recommends that AEDs Should classify Coarse Ventricular Fibrillation and Rapid Ventricular Tachycardia as shockable rhythms 1 The AEDs manufactured The Company use a proprietary Arrhythmia Detection Algorithm that has been designed to detect Coarse Ventricular Fibrillation and Rapid Ventricular Tachycardia The algorithm treats all other rhythms as non shockable The following figures show Coarse Ventricular Fibrillation and Rapid Ventricular Tachycardia mde Er Amplaude mv Ventricular Fibrillation The Arrhythmia Detection Algorithm uses sophisticated Digital Signal Processing techniques to classify the input ECG signals The following chart shows the overview of the steps done during rhythm classification lipur Preprocaegsad filtered ECG Check Amplitude and Frequency Spectrum Chack Baseline Contents Determine and Check ECG rate ECG Classification The Arrhythmia Detection Algorithm has been validated using Human ECG Databases The Databases consist of records from the Physionet Physiologic Signal Archives for Biomedical Research and ECG recordings from the
29. he signal output of the device can be fed to the defibrillators manufactured by The Company to simulate a patient This is useful during trainings on defibrillator use and testing of defibrillators Defibrillator Analyzer Function The CU SM1 can be used to measure the leading edge voltage and the energy output of any defibrillator Training Mode In training mode the CU SM1 switches from a shockable rhythm to normal sinus rhythm after a defibrillating shock is delivered This is useful in simulating a successful resuscitation CU SM1 SPECIFICATIONS Defibrillator Output Energy Measurement Maximum Energy 200Joules Maximum Voltage 2000V Accuracy Energy Measurement 10 of actual value 50J to 200J range Voltage Measurement 10 of actual value Load Resistance 909 5 ECG Waveforms Normal Sinus Rhythm Rates 30 60 120 240 bpm Rate Accuracy 1 of selection Amplitude 1mV peak to peak Amplitude Accuracy 5 Other Waveforms Asystole FVF fine ventricular fibrillation 38 VF ventricular fibrillation SVT supraventricular fibrillation VT138 ventricular tachycardia 138 bpm VT180 ventricular tachycardia 180 bpm General Power 9V battery Operating Conditions Temperature 0 C to 55 C Humidity 0 to 75 Storage Conditions Temperature 20 C to 75 C Humidity 10 to 90 Display Liquid Crystal Display alphanumeric 2 lines 20 characters Dimensions width X length X height 230mm X
30. hly Portable The device weighs only 230 g including the 2 AAA batteries The user has the choice between chest and hand electrodes When the hand electrodes are used the device is capable of acquiring and displaying Lead I ECG only Multiple Lead Capabilities When the chest electrodes are used the device can acquire and display Lead I or II or III The switching is done via an internal analog signal multiplexer thus there is no need to move the electrodes when switching between leads Abnormal Heart Rate Alarm The device can be set to give off an alarm when the detected heart rate is beyond the limits defined by the user ECG Data Recording The ECG data acquired from the patient is automatically recorded in the internal flash memory of the device This record can be subsequently downloaded to a personal computer using the CU EX1 data management software from The Company A total of 600 minutes of ECG record can be stored in the device s nonvolatile internal flash memory Heart Rate Trend The device calculates the average heart rate of the acquired ECG every minute and displays the result in a heart rate trend graph CU PH1 SPECIFICATIONS ECG e Lead I II III with 3 Cable Electrodes e Lead I with hand electrodes e Bandwidth 0 3 to 40 Hz e ECG Vertical Scales 5 10 and 20 mm mvV e ECG Sweep speed 25mm s e ECG Heart Rate 30 300 bpm lt 2 e CMRR gt 90 dB e DC offset correction 300 mV e Sample
31. hroughout Shockable rhythm 1 shock Non shockable rhythm Battery low Accessories Accessories Description Remote Control For AED Trainer raining manikin Included CPR training 10 Scenarios 3 Custom Scenarios Power Off NSR80 Rhythm VF Rhythm VT Rhythm Low Battery Programming Kit For AED Trainer Support multi language through upload main S W Edit user s scenarios for certain purpose and add other scenarios CU ERT SPECIFICATIONS 2 ECG Monitor e Patient connection Defibrillation Pads ECG Electrodes e Bandwidth Monitoring Mode 0 3 to 40 Hz 3 dB AED mode EMS 1 Hz to 30 Hz e ECG size Auto scaled 0 3 to 1 mV signals are displayed with 10mm mvV gain outside of that range the peak to peak value is displayed as 10 mm on the LCD display e Heart rate Digital 30 to 300 bpm 2 Defibrillator e Operating mode Semi automatic e Waveform CH he Biphasic Technology BTE type e Energy 150J into a 50Q load default setting Preprogrammed selection 150J 150J 150J 150J 150J 180J 150J 180J 180 e Charging time Less than 10 seconds e Sensitivity amp Specificity Meets AAMI guidelines e Detection Level gt 0 1 mV ECG e Defibrillation Electrodes Multifunction self adhesive adult electrodes Disposable Pre gelled 24 Voice amp Text Prompt e Voice amp text prompts guide the user through the protocol e All the user interfaces are supported in local language for easy use an
32. hs only approximately 2 8 kg It comes with an optional Carrying Case that could contain all the necessary devices and accessories needed for a rescue operation Versatile Power Supply The Paramedic CU ER3 is eguipped with a rechargeable Nickel Metal Hydride battery pack as a standard component The battery may be recharged through an AC adapter standard accessory or through a car cigar lighter jack power cord optional The battery has a capacity of 200 shocks 150 Joules each when new and fully charged Rescue Data Storage The data collected during a rescue operation is stored in the internal flash memory or the optional external SmartMedia Card When the SmartMedia card is used the option to record audio signals during a rescue operation may be turned ON not available when recording in internal flash memory The data can be downloaded to a personal computer using the CU EX1 data management software for archiving review and printing Automated Self Tests To ensure that the Paramedic CU ER3 is always ready for a rescue operation the device is programmed to run self tests automatically the battery has to be connected and should have sufficient charge Prompts and alarms are given off if the device fails the self tests CU ERS5 Defb amp Monitor e AED and Manual Mode Defibrillation Synchronized Cardioversion e Reusable External Paddle Adult Paediatric amp Multifunction Defib Pads e ECG Monitoring Mode Le
33. ial action potential Notice that for a stimulus of the same amplitude duration and timing the biphasic stimulus is successful at activating the cell whereas the monophasic stimulus fails to activate the cell Monophasic biphasic Keener et al J theor Biol 1999 200 1 17 The difference between monophasic and biphasic waveform is qualitatively similar but varies quantitatively for different parameter values The fundamental difference is that first phase of the biphasic pulse acts as a pre pulse to remove inactivation from the heart cell accelerating its recovery and thereby lowering the activation threshold for defibrillation prior to second phase of biphasic pulse which is reversed current flow This means that Biphasic shock is more effective than a monophasic shock at eliminating reentrant electrical activity in an ionic model of cardiac ventricular electrical activity 7 Enough energy for restoring heart rhythm The Biphasic Truncated Exponential waveform uses a lower energy than the Monophasic waveform But the lower energy of biphasic shock is more efficient than high energy of the monophasic shock for defibrillation to restore heart rhythm Monophasic at 200 Joules Biphasic Truncated Exponential at 150 Joules BTE 53 150 Current Mono 43 200 Time Amps The high defibrillation efficacy of the particular 150 J impedance compensating biphasic waveform is observe
34. ing 17 55 29 Shock Advise 17 55 37 Armed 8 17 55 39 Shock 2 17 55 45 Analyzing 17 55 53 Shock Advise 17 57 01 Armed 4 17 57 03 Shock 3 17 57 07 Paused For C 17 53 17 Analyzing 17 58 21 No Shock Ad 17 53 21 Analyzing 17 53 25 Shock Advise 17 59 33 Armed 17 59 49 Disarmed 17 58 53 Analyzing 17 58 57 No Shock Ad 18 00 16 Power O 26 Printing The CU Expert enables the user to print the ECG waveform and rescue event highlights using a printer connected to the PC The user has the choice to print the whole record opened part of the record or the rescue event highlights only KA System Reguirements Hardware Software Reguirements The following hardware and software are needed when transferring data from the Paramedic CU ER1 to a PC The user may choose between the UART cable and the IrDA Com Port Serial Adapter for the data transmission a Paramedic CU ER1 on CU Expert c CU Expert Version 1 00 S W 4 e UART Cable PC Requirements Operating System Minimum Ram Minimum PC Requirements Windows 98 SE 32 MB Windows ME 32 MB Windows 2000 64 MB Windows XP 128 MB Recommended PC Setup Windows XP or 128 MB 2000 j LT he b PC d Device Key File ABEB KAKKA kif f IrDA Com port Serial Adapter Processor Pendium 150Mhz Pendium 150Mhz Pendium 150Mhz Pendium 233Mhz Pendium 500Mhz Hard disk Free
35. l external flash memory card Power is provided by a rechargeable Nickel Metal Hydride battery DEFIBRILLATORS I PAD NF1200 Intelligence Public Access Defibrillator Size 220mm X 260mm X 70mm LX W X M Weight Approximately 2 2 Kg Self Test Periodic test daily weekly monthly Battery Insertion Test Battery 12 Volt DC 4 2 Ah lithium manganese dioxide disposable long life primary cell Waveform e cube Biphasic Technology impedance compensated Energy 200 Joules nominal into a 509 load The i PAD NF1200 is a semi automated external defibrillator designed for minimally trained individuals It provides simple and direct voice prompts and indications for a straightforward rescue operation It is lightweight and battery powered for maximum portability The t PAD NF1200 is designed to treat Ventricular Fibrillation VF and Fast Ventricular Tachycardia FVT These two are the most common causes of sudden cardiac arrest SCA In SCA the heart of the victim suddenly stops pumping This condition occurs suddenly to any age group without any warning The only effective treatment for VF is the application of a defibrillating shock Simple operation gt LED Status Indicators Patented e cube Biphasic Truncated Exponential shock waveform Automatic self testing gt Especially designed for public usage Economic standard package 11 USING THE NF1200 Rescue Preparetion 1 Open the top cover
36. ngle and dual capacitor biphasic waveforms for nonthoracotomy canine internal defibrillation J Am Coll Cardiol 1989 14 242 5 Kavanagh KM Tang ASL Rollins DL Smith WM Ideker RE Comparison of the internal defibrillation thresholds for monophasic and double and single capacitor biphasic waveforms J Am Coll Cardiol 1989 14 1343 9 Winkle RA Mead RH Ruder MA et al Improved low energy defibrillation efficacy in man with the use of a biphasic truncated exponential waveform Am Heart J 1989 117 122 7 Ruppel R Siebels J Schneider MA Kuck KH The single endocardial lead configuration for ICD implantation biphasic versus monophasic waveform abstract J Am Coll Cardiol 1993 21 128A T Schneider et al Multicenter Randomized Controlled Trial of 150 J Biphasic Shocks Compared With 200 to 360 J Monophasic Shocks in the Resuscitation of Out of Hospital Cardiac Arrest Victims Circulation 2000 102 1780 1787 Steven L Higgins et al A comparison of biphasic and monophasic shocks for external defibrillation Prehospital Emergency Care 2000 4 305 313 J P KEENER T J LEWIS The Biphasic Mystery Why a Biphasic Shock is More Effective than a Monophasic Shock for De5brillation J theor Biol 1999 200 1 17 AHA Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care an international consensus on science Circulation 2000 102 Suppl 1 U Achleitner et al Waveform analysis of biphasic external d
37. ries AEDs to become the standard tool that is fast effective and extremely easy to use so that more lives are saved in more places Aiming at making The Company a leading medical corporation in the globally connected world of the heart safe community The Company introduced its first brand new AED in 2002 which was subseguently reviewed and upgraded till 2004 Since the introduction of Paramedic CU ER1 AED we have made great strides in putting a lot of importance on the guality of our products and services to encourage the development and adoption of the Paramedic series AEDs by the heart safe community The Company is now mature and well gualified to meet the needs of the global community The challenge now with us is to sustain corporate spirits the competent challenging collaborative clean credible and contributive business units we have created in the last 4 years and continue to spread the benefits of the heart safe community for patients customers and businesses CORPORATE OUALITY POLICY Since we design develop manufacture sell and service our brand new Paramedic series AED and other products as well we put a lot of importance on the quality of our products and services It is our way of showing to our partners and customers not only our concern for safety and reliability but also our belief that guality is the key for long term success in business Do it right the first time to eliminate costly rework Listen to and l
38. stance ohms Research has shown that patient s chest resistance can vary significantly from patient to patient Patients with low impedance are generally easier to defibrillate because the flow of current meets little resistance Those with higher impedance may be more difficult to defibrillate According to the International Guidelines 2000 by the American Heart Association AHA in collaboration with the International Liaison Committee On Resuscitation ILCOR average adult impedance is 70 80 ohms Defibrillation energy should be designed to optimize the delivery of current over a wide range of patient impedances Too much current to the myocardial cells can cause damage to the cells and result in an unsuccessful defibrillation Too little current to the myocardial tissue cells will not depolarize the cells and result in an unsuccessful defibrillation 4 r 50 E cube Biphasic waveform is designed 50 which is easy to compensate patient s impedance variance more efficient than other monophasic waveform and deliver enough energy for restoring heart rhythm 20 10 E cube Biphasic waveform is designed q which is easy to compensate patient s 2 impedance variance more efficient than other monophasic waveform and deliver enough energy for restoring heart rhythm Easy to compensate patient s impedance variance E cube Biphasic waveform is controlled with the patient s impedance through the defibrill
39. t may also run using a supplied AC DC adapter ECG signal acguisition is achieved through a five electrode ECG acguisition assembly with disposable electrodes while SPO2 signal acguisition is done using the recommended Nellcor SPO2 Sensors Ei S n T Y ei User interaction is through three function buttons LEFT RIGHT and MENU Through these buttons the settings of the device can be changed ECG signals can be recorded in the internal nonvolatile memory of the device The stored signals can later be reviewed These recorded signals can also be transferred to a personal computer that is running the CU Expert ECG Data Management Software The CU Expert is available as an option The i Viewer CU PH2 analyzes the signal it acquires from the user and determines the heart rate of the user The device prompts the user through the beeper and the LED alarm indicator if it detects an abnormal heart rate Abnormal heart rate is any heart rate beyond the normal limits defined by the user kAConvenient to use in Hospital emergency rooms Hospital intensive care unit Pre hospital emergency monitoring ElSpecification ECG Lead I II III aVL aVR aVF V with 5 electrode cable ECG Heart Rate 30 300 bpm 2 SpO2 Module Pulse rate 20 250 bpm 42 Saturation 70 100 SpO2 3 Perfusion 0 2 Display Sweep speed 25mm sec nominal Viewing time 3 2 seconds Backligh C
40. y of the shock to be delivered You may also perform synchronous cardioversion for the treatment of a trial fibrillation in this mode In synchronous cardioversion the defibrillating shock is delivered within 60 milliseconds of the occurrence of a QRS peak in the patient s ECG In this mode the operator has the freedom to set the energy level of the defibrillating shock The choices are in Joules 2 3 5 7 10 20 30 50 70 100 150 200 ECG Monitoring Mode The Paramedic CU ER3 may also be used to do ECG monitoring only when it is in Manual mode ECG monitoring only is done by connecting the custom designed ECG monitoring cable assembly from The Company No shocks may be delivered when the ECG monitoring cable assembly is connected to the Paramedic CU ER3 22 The Paramedic CU ER3 uses two kinds of pads These are Multifunction defibrillator pads used for ECG acquisition and shock delivery These pads are used during rescue operations gt ECG pads used for ECG acquisition only together with the ECG monitoring cable and connector assembly The Paramedic CU ER3 is capable of monitoring pulse oximetry SPO2 Nellcor in manual and AED modes Pulse oximetry measurement is automatically done when the pulse oximetry sensor is connected to the appropriate port on the device 2 SPO2 Monitoring is indicated when it is beneficial to assess a patient s oxygen saturation level Highly portable The Paramedic CU ER3 weig
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