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Rescue Life - User Manual Rev. 3.1

APPENDIX E – INSTRUCTION FOR USE FOR DISPOSABLE
MULTIFUNCTION ELECTRODES FOR DEFIBRILLATOR

Disposable Multifunctional

Electrodes for Defibrillator

(defibrillation, synchronized stimulation, transcutaneous cardiac stimulation, ECG monitoring)

DFB

STD

/ DFB

PRC

(Adult)

DFB

PED

STD

/ DFB

PED

PRC

(Pediatric)

0068

V2.0

Rev. 2018/02

Summary of Contents for Rescue LIFE

Page 1: ...Rescue LIFE EXTERNAL BIPHASIC DEFIBRILLATOR and MONITOR USER MANUAL ELPRO S r l Strada del Rondello 5 10028 Trofarello TO ITALY Rev 3 1 Distributed by...

Page 2: ...Distributed by Rescue Life User Manual Rev 3 1...

Page 3: ...ING ON 5 ELECTRICAL SAFETY GUIDELINES 5 SYMBOLS USED 6 INTRODUCTION 8 UNPACKING AND INSPECTING 8 DEVICE OPERATION AND STORAGE GUIDELINES 8 8 CLEANING AND MAINTENANCE 9 CONNECTING TO POWER 10 BATTERY C...

Page 4: ...32 DEFIBRILLATION MODE 33 DEFIBRILLATOR PROCEDURE IN MANUAL MODE 34 DEFIBRILLATOR PROCEDURE IN ADVISORY MODE ADV 35 AUTOMATED EXTERNAL DEFIBRILLATION AED 36 INDICATIONS FOR USE 36 ECG ANALYSIS ALGORI...

Page 5: ...SE SCREEN 60 DATA RETRIEVAL 61 DATE AND TIME SETUP 62 PRINTING AND PAPER CHANGE 62 AUTO TEST 63 RESCUE LIFE CHECKLIST 65 APPENDIX A 66 CLINICAL INFORMATION 66 How does biphasic waveform defibrillate 6...

Page 6: ...al Rev 3 1 V APPENDIX D 76 TECHNICAL FEATURES 76 APPENDIX E INSTRUCTION FOR USE FOR DISPOSABLE MULTIFUNCTION ELECTRODES FOR DEFIBRILLATOR 81 OPERATING INSTRUCTION 83 DECLARATION OF EC CONFORMITY 88 AP...

Page 7: ...e information and procedures related to all features and options of the RESCUE LIFE monitor defibrillator Your RESCUE LIFE monitor defibrillator may not have all of these features or optional Please r...

Page 8: ...our customers to ensure that the appropriate person s within their organization have access to this information including general safety information which are given in this manual GENERAL Assure your...

Page 9: ...DENTALLY CREATING CURRENT PATH FOR THE DEFIBRILLATION IMPULSE THE PARTS OF THE PATIENT BODY SUCH AS THE HEAD OR LIMBS MUST NOT BE IN TOUCH WITH METAL PARTS BED FRAMES OR STRETCHERS THE PATIENT MUST NO...

Page 10: ...IL DO NOT CLEAN WITH KETONES OR OTHER FLAMMABLE AGENTS DO NOT AUTOCLAVE OR STERILIZE THIS DEFIBRILLATOR OR ACCESSORIES UNLESS OTHERWISE SPECIFIED USE CARE WHEN OPERATING THIS DEVICE CLOSE TO OXYGEN SO...

Page 11: ...MONITOR SCREEN THE OPERATOR HAS TO CONNECT IMMEDIATELY THE AC POWER CORD TO AN OUTLET ELECTRICAL SAFETY GUIDELINES Use only the original power cord during recharging The right value for the AC power...

Page 12: ...nufacturer identification Date of production Defibrillation proof BF type Defibrillation proof CF type Alternated Class II Danger of an electrical shock The user must to consult the instructions for u...

Page 13: ...Rev 3 1 7 Follow local regulations on battery disposal or recycling CE Mark Notified Body identification Fragile content handle with care on the package To keep dry and to not exposure to weathering o...

Page 14: ...S Do not operate or store the device in conditions that are beyond the following specified limits Operating Conditions Temperature 5 C to 46 C Humidity 10 to 95 non condensing Storage Conditions witho...

Page 15: ...SSORIES WITH BLEACH BLEACH DILUTION OR PHENOLIC COMPOUNDS DO NOT USE ABRASIVE OR FLAMMABLE CLEANING AGENTS DO NOT ATTEMPT TO STERILIZE THIS DEVICE OR ANY ACCESSORIES UNLESS OTHERWISE SPECIFIED IN ACCE...

Page 16: ...d is disconnected from an AC outlet or from the defibrillator The internal Lithium Ion battery is rechargeable and intended to be used for standby operation A new completely charged battery provides a...

Page 17: ...To see the battery charge status switch on the device with pads connector not attached When the battery value is under 10 a message appears on display CHARGE BATTERY OR SYSTEM WILL SHUT OFF Insert th...

Page 18: ...oduct name Product serial number Date of purchase Name of sales representative Information of customer and a brief description of the problems encountered All of the service works for the product must...

Page 19: ...prevent possible electrical and mechanical discrepancies When the device is not functioning properly it has to be submitted for maintenance immediately When any abnormalities are found in the device o...

Page 20: ...rrence of the ECG R peak The RESCUE LIFE in the basic configuration has only the manual mode available and the ECG monitoring can be done by defibrillation pads 1 trace or by 5 wire ECG monitoring cab...

Page 21: ...y means of Synchronous defibrillation cardioversion patients with ECG s that show the presence of Atrial Fibrillation It is designed to monitor patient ECG by means of the multiple signal acquisition...

Page 22: ...ess Absence of normal breathing and Lack of detectable pulse Rhythms need a shock Synchronous defibrillation the shock delivery is synchronized with the R peak of the patient s ECG In synchronous defi...

Page 23: ...e disconnected the battery status and clock set up screen will appear In this case to start ECG monitoring press F1 key To access the DATA BASE only on the AED models press F2 key MEMORY To switch off...

Page 24: ...with the standard pads press both push buttons on the pads handles FUNCTION KEYS F1 F5 These keys are used for different functions according to the screen where they are used KEY INITIAL SCREEN OPERAT...

Page 25: ...hted it informs that connection to AC line is carried CASE B When the connection to AC line is removed the LED will switch off Indicator LED BATTERY CHARGE CASE A CASE B CASE A When the LED indicator...

Page 26: ...pull the lead lever and turn left the connector ECG PATIENT CABLE ECG patient cable input RESCUE LIFE displays 3 6 or 12 traces SpO2 INPUT optional When the SpO2 sensor is connected saturation values...

Page 27: ...ith the defibrillation paddles disconnected Battery status and clock are shown Using function keys it is possible to enter in different screens START F1 to enter in Operational screen MEMORY F2 to ent...

Page 28: ...nual Rev 3 1 22 OPERATIONAL SCREEN At power ON if the paddles are connected the RESCUE LIFE will start the operation If the paddles are not connected the start screen will be displayed Press START F1...

Page 29: ...UE LIFE socket otherwise system will shout down automatically in 2 minutes During this time defibrillation functions are disabled DATE AND TIME date and time are shown OPERATION MODE operation mode se...

Page 30: ...printing PACER F3 it allows to enter in Pacemaker screen optional SYNC F4 it allows to activate and deactivate sync mode MENU F5 it allows to open menu SET UP MENU The START UP menu is accessible pres...

Page 31: ...efers to the bandwidth of the signal In MONITOR mode bandwidth in 0 6 Hz to 40 Hz in DIAGNOSTIC mode bandwidth is 0 05 Hz to 120 Hz Notch filter is always active If the ECG trace is acquired by defibr...

Page 32: ...ator is charged using this mode the standard impedance of 50 ohm is assumed ELPRO S r l recommended to make one functional check preventive maintenance and electrical safety test at least once a year...

Page 33: ...ectrodes with expired Use By date codes Disposable electrodes are intended for a single use For best ECG monitoring results use silver silver chloride Ag AgCl electrodes Other types of electrodes will...

Page 34: ...Distributed by Rescue Life User Manual Rev 3 1 28 Precordial lead electrodes sites for the 10 wires ECG cable Figure I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 derivations on frontal and orizzontal planes...

Page 35: ...ation The American Heart Association has identified the following as critical links in the chain of survival from cardiac arrest Early access Early CPR by first responders or bystanders Early defibril...

Page 36: ...for treating atrial fibrillation atrial flutter paroxysmal supraventricular tachycardia and in relatively stable patients ventricular tachycardia The biphasic defibrillation waveform used in this dev...

Page 37: ...ne near the top of the package Remove the pads from the package and follow the directions and diagram showing proper defibrillation pad placement located on the defibrillation pad package The correct...

Page 38: ...ng them Remove the coating only when the electrode is ready to be applied Put the electrodes with the adhesive side of the patient s skin Place the electrodes as shown in the diagram The placement of...

Page 39: ...SCUE LIFE automatically analyze heart rhythm In ADVISORY mode ADV RESCUE LIFE only analyzes and suggest if patient needs defibrillation after that users have to choose energy value charge defibrillato...

Page 40: ...ck 9 The shock has to be released within 25 sec from the charge completed after 25 sec the RESCUE LIFE will discharge internally 10 If the defibrillation is not required press the DISARM F1 key to dis...

Page 41: ...tart charging 5 If you are using disposable pads press the CHARGE button on the device panel to start charging 6 On the screen the charge status bar indicates that the charging procedure is on at the...

Page 42: ...in basic life support CPR AED The device is indicated for emergency treatment of victims exhibiting the following symptoms of a sudden cardiac arrest un consciousness absence of normal breathing and...

Page 43: ...nded by the European Resuscitation Council ERC 1 1 European Resuscitation Council ERC Guidelines for cardiopulmonary resuscitation CPR European Resuscitation Council vol 81 2010 Upon detecting a shock...

Page 44: ...e display below status battery indicator It means that device will record for 1 minute the ECG trace on the USB FLASH STORAGE 3 If RESCUE LIFE recognizes a shockable rhythm it automatically will charg...

Page 45: ...User Manual Rev 3 1 39 DO NOT TOUCH THE PATIENT DURING HEART RHYTHM ANALYSIS DO NOT TOUCH THE PATIENT DURING DEFIBRILLATION TURNING OFF THE DEFIBRILLATOR BEFORE RECORDING IS FINISHED IT WILL PRODUCE...

Page 46: ...Distributed by Rescue Life User Manual Rev 3 1 40 SEMIAUTOMATIC AED MODE FLOW CHART...

Page 47: ...at the device is doing an analysis of the patient s ECG SHOCK ADVISED Indicates that the patient has a shockable ECG rhythm PRESS THE RED BUTTON NOW Indicates that the user have to press the SHOCK but...

Page 48: ...probability of successful pacing or of skeletal muscle activity The failure to successfully pace a patient is not a reliable indicator of pacemaker performance In the same way the patient s muscular...

Page 49: ...set pacing parameter KEY FUNCTION RYTHM F1 Press key and use the Speed Dial to change the value to set the pacing rhythm CURRENT F2 Press key and use the Speed Dial to change the value to set the pac...

Page 50: ...d positioned below the right clavicle Lateral plate positioned on the middle axillary line at the height of his left nipple position V6 PACING PROCEDURE 1 Switch on the device pressing the ON OFF butt...

Page 51: ...light absorption by that blood changes during the pulse plethysmography A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorp...

Page 52: ...eusable sensors may be reused on different patients after cleaning and disinfecting Do not use other sensors aside from the ones recommended Before using carefully read the sensor directions for use i...

Page 53: ...Medical designed the Advantage A to meet the needs of the most challenging clinical application with internal automatic modes low voltage communication protocols the lowest power consumption in the in...

Page 54: ...ally referred to as the mean arterial pressure MAP As cuff deflation continues the diastolic pressure can be determined based upon the rapidly diminishing amplitude of the pressure fluctuations Thus s...

Page 55: ...IZED BY ELPRO S R L Accuracy of any blood pressure measurement may be affected by the position of the subject his or her physical condition and use outside of the operating instructions detailed in th...

Page 56: ...material of the cuff Petechia a minute reddish or purplish spot containing blood that appears in the skin formation or Rumple Leede phenomenon multiple petechia on the forearm following the applicatio...

Page 57: ...g The cuff should fit snug to the patient s arm for maximum oscillometric signal quality An appropriate sized cuff should be placed on the non dominate arm where the lower edge of the cuff is located...

Page 58: ...surements from both arms are same When a cuff is going to be positioned on a patient for an extended length of time be sure to occasionally check the limb for proper circulation ACTIVATION AND OPERATI...

Page 59: ...SYS DIA MEAN SET F4 to enter the NIBP set up menu EXIT F5 to exit the NIBP and return to the defibrillator functions NIBP SET UP MENU Pressing the SET F4 key the NIBP set up menu is displayed To modi...

Page 60: ...yed and printed if the automatic print mode is active In manual print mode press the PRINT F2 key to get the hardcopy of the measurement For an automatic measurement enter the set menu select the auto...

Page 61: ...n The patient may have been moving too much Check that the cuff is in the correct position Check that the correct size cuff is being applied EC 4 Exceeded measurement time limit Corrective Action The...

Page 62: ...he hose connections are not damaged or loose EC 88 Safety Timeout Corrective Action Check the patient Check that the cuff is in the correct position The patient may have been moving too much Take anot...

Page 63: ...ppendix 3 Specifications Method of Measurement Oscillometric Diastolic values correspond to Phase 5 Korotkoff sounds Blood Pressure Range Systolic ADULT 40 260 mmHg PEDIATRIC 40 160 mmHg NEONATE 40 13...

Page 64: ...Previous Systolic 30 mmHg NEONATE Previous Systolic 20 mmHg Clinical Accuracy Meets accuracy requirements of ANSI AAMI SP10 2002 and EN1060 4 2004 Pressure Transducer Accuracy 3 mmHg between 0 mmHg an...

Page 65: ...abort a BP measurement if cuff pressure exceeds 300 mmHg Adult Pediatric modes or 150 mmHg Neonate mode at any time the cuff has been inflated for 180 seconds above 15 mmHg Adult Pediatric modes or 90...

Page 66: ...recording is available only in AED mode The recording will start automatically each time the ANALISYS starts When RESCUE LIFE is recording on the top side of the display below battery status indicato...

Page 67: ...t recent file Pressing the DOWN F1 key the next 10 files will be shown Pressing the TOP F2 key the previous 10 file will be shown Pressing the Speed Dial will select a file from the list and rotating...

Page 68: ...int mode enter the menu and select MANUAL or AUTOMTIC mode from PRINT MODE MANUAL MODE To start printing press the PRINT F2 key The hardcopy will start with the set up parameters and with the ECG trac...

Page 69: ...g the leads I II III While print is in progress enter the menu and select the successive derivations aVR aVL aVF Repeat until you have printed all leads Then stop printing AUTO TEST RESCUE LIFE is equ...

Page 70: ...ounds some fault the system will indicate it Note the error code and communicate it to the authorized technical service Pressing the PRINT F3 you can print the test report EVERY REPORT HARDCOPY REFERS...

Page 71: ...ctor and the cable Make sure the paddles are clean and free of traces of gel To test the paddles switch on defibrillator set an energy of 1 Joule charge the capacitor by pressing the buttons on the pa...

Page 72: ...RILLATE 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 techni...

Page 73: ...iaison 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 m...

Page 74: ...e patient Biphasic technology increases the duration of current flow for patients with high impedance When escalating energy for example 150J to 180J it delivers the electrical energy with higher volt...

Page 75: ...Distributed by Rescue Life User Manual Rev 3 1 69...

Page 76: ...ween 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 p...

Page 77: ...t higher rates resulting in more patients who achieved a return of spontaneous circulation Although survival rates to hospital admission and discharge did not differ discharged patients who had been r...

Page 78: ...n 2000 102 1780 1787 6 Steven L Higgins et al A comparison of biphasic and monophasic shocks for external defibrillation Prehospital Emergency Care 2000 4 305 313 7 J P KEENER T J LEWIS The Biphasic M...

Page 79: ...RLFS 008 RLFS 009 RLFS 0010 1 Standard Electrodes for defibrillation 5 leads ECG cable 10 leads ECG cable Adult SpO2 sensor Pediatric SpO2 sensor AC Adapter Disposable electrodes cable Adult disposab...

Page 80: ...ion electrodes for a maximum of 230 Joule 150J 25ohm 230J 50ohm 230J 75ohm 230J 100ohm 230J 125ohm 230J 150ohm For impedance value of 40ohm or less the 230J 175ohm maximum energy is 150J If the energy...

Page 81: ...displayed on the screen The device can not automatically set the sync mode In the sync mode the device releases the defibrillation shock only when the R peak in the QRS complex is detected The maximum...

Page 82: ...filter base line Traces 3 3 1 I II III aVR aVF aVL V with 5 wires patient cable Traces 3 3 6 I II III aVR aVF aVL V1 to V6 with 10 wires patient cable Heart rate Digital readout on the display from 2...

Page 83: ...ry internal rechargeable charging time maximum 3 hours capacity 150 shocks at 230 J battery fully charged Manual mode Energy range 1 230 J from 1 10 J in 1 J steps from 10 230 J in 10 J steps Commands...

Page 84: ...pts Shockable rhythms VF with amplitude 0 15 mV and VT with rhythm 150 bpm Sensitivity Shockable rhythm VF 95 Shockable rhythm VT 75 Specificity Normal sinusoidal rhythm 99 Asystole and other non shoc...

Page 85: ...eonatal 20 100 mmHG PR RANGE 30 220 BPM PR Accuracy 2 or 3 bpm Transducer Accuracy 3 mmHg over full range in operating conditions Operating Modes Manual Long Term Automatic Stat Service Auto Interval...

Page 86: ...nmental Temperature without Disposable Multifunction Electrodes for defibrillator Operational 5 46 C Storage 20 50 C Relative humidity 10 95 Temperature without Disposable Multifunction Electrodes for...

Page 87: ...DISPOSABLE MULTIFUNCTION ELECTRODES FOR DEFIBRILLATOR Disposable Multifunctional Electrodes for Defibrillator defibrillation synchronized stimulation transcutaneous cardiac stimulation ECG monitoring...

Page 88: ...n Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Circulation 2010 122 S640 S946 Journal of the American Heart Association Editor Mary Fran Hazinski RN...

Page 89: ...le paddles CONTRAINDICATIONS PROGETTI disposable multifunction electrodes for adults are generally contraindicated in patients younger than 8 years old 2 weighing less than 25kg 3 4 but can be used if...

Page 90: ...evere arrhythmic disease may develop The points where it is possible to apply the adhesive electrodes are listed in PLACEMENT AND POLARITY Uncover the chest and prepare the skin Remove excessive hair...

Page 91: ...therapy it is not relevant which electrode pad apex sternum is placed in one of the two positions 2 Regarding the polarity of the electrodes in unique version adult pediatric follow the directions on...

Page 92: ...e adhesive pads Do not use the multifunction electrodes if the connector the cable or the clips appear to be damaged Check on the operating instructions of the defibrillator at which safety distances...

Page 93: ...on for use We recommend to report opportunely any malfunction or defect of the product to ELPRO S r l or PROGETTI S r l DESCRIPTION OF USED SYMBOLS 0068 EC Mark Notified Body Identification Manufactur...

Page 94: ...ISO 14971 2012 EN ISO 15223 1 2012 MEDDEV 2 7 1 Rev 4 MEDDEV 2 12 1 Rev 8 MEDDEV 2 12 2 Rev 2 SERIAL NUMBER WE HEREWITH DECLARE THAT THE ABOVE MENTIONED PRODUCT S MEET THE TRANSPOSITION INTO NATIONAL...

Page 95: ...ELPRO S r l This warranty does not cover any accessories ELPRO S r l will replace damaged parts and components according to its option ELPRO S r l will replace cost free those parts and components un...

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Page 98: ...Rescue Life User Manual vers 3 1 ELPRO S r l Strada del Rondello 5 10028 Trofarello TO ITALY www elpromedical com Distributed by...

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