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Safety Considerations

M3860A and M3861A H

EARTSTREAM

 FR2 Defibrillator

5-5

5

Monitoring Cautions

Maintenance Cautions

SAFETY LEVEL

POSSIBLE MISINTERPRETATION OF ECG RECORDINGS

CAUTION

The LCD screen on the H

EARTSTREAM

 FR2 model M3860A is intended only for basic ECG rhythm 

identification. The frequency response of the monitor screen is not intended to provide the resolution 
needed for diagnostic and ST segment interpretation.

SAFETY LEVEL

POSSIBLE FIRE OR SHOCK HAZARD

CAUTION

Electrical shock hazard. Dangerous high voltages and currents are present. Do not open the H

EARTSTREAM

 

FR2, remove its covers, or attempt repair. There are no user-serviceable components in the H

EARTSTREAM

 

FR2. The H

EARTSTREAM

 FR2 should be returned to an authorized service center for repair.

CAUTION

Improper maintenance may damage the H

EARTSTREAM

 FR2 or cause it to function improperly. Maintain the 

H

EARTSTREAM

 FR2 only as described in this User's Guide or as designated by your program's Medical 

Director.

Содержание Heartstream FR2

Страница 1: ...Agilent Heartstream FR2 M3860A M3861A Agilent Technologies www ardusmedical com...

Страница 2: ...User s Guide Agilent M3860A M3861A Heartstream FR2 Semi Automatic External Defibrillator AED...

Страница 3: ...ptional Used to store and review information about the incident including ECG and optional voice recording Data card tray Special sleeve that holds the data card and fits into the data card port to he...

Страница 4: ...PATIENT IS UNRESPONSIVE NOT BREATHING WITHOUT A PULSE TURN ON FOLLOW PROMPTS PRESS SHOCK BUTTON IF INSTRUCTED HEARTSTREAM FR2 AED QUICK REFERENCE GUIDE...

Страница 5: ...oeblingen Germany 49 7031 14 5151 CAUTION FEDERAL LAW USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN The HEARTSTREAM FR2 is designed to be used only with Agilent Technologies appr...

Страница 6: ...ur HEARTSTREAM FR2 Overview 3 1 Step 1 Preparation 3 2 Step 2 ECG Analysis and Monitoring 3 3 Step 3 Shock Delivery 3 4 4 Maintaining Testing and Troubleshooting Your HEARTSTREAM FR2 Overview 4 1 Main...

Страница 7: ...tocol Parameters 6 2 Manual Override Parameters 6 4 Using Setup Features 6 6 Reviewing Current Setup 6 6 Revising Setup 6 7 Receiving Setup 6 7 Reading Setup 6 8 Sending and Receiving Clock Settings 6...

Страница 8: ...A Accessories for the HEARTSTREAM FR2 B Technical Specifications C Differences between the FORERUNNER and the HEARTSTREAM FR2 AEDs D Glossary of Symbols and Controls E Glossary of Terms F Clinical Su...

Страница 9: ...iv Contents Notes...

Страница 10: ...t the base of the FR2 See the diagram on the inside front cover for details The HEARTSTREAM FR2 is available in two models the M3860A and the M3861A They share a set of basic features In addition the...

Страница 11: ...al defibrillation therapy to someone in cardiac arrest Defibrillation therapy is the best available way to treat a variety of potentially fatal heart arrhythmias The FR2 is extremely easy to use When...

Страница 12: ...in a gray plastic case There is a yellow latch at one end that holds the battery pack in place when it is correctly installed in the FR2 Before installing the battery make sure the defibrillation pad...

Страница 13: ...ed lets you review the history of the FR2 review the history of the battery being used access setup data set the clock or return to the first menu See Chapter 4 Maintaining Testing and Troubleshooting...

Страница 14: ...nd Advanced Mode Features for instructions Manually set the date and the time To manually set the clock 1 Use the lower Option button to move the highlight bar to the part of the clock setting you wan...

Страница 15: ...and the selftest will start automatically NOTE If you connect defibrillation pads that are applied to the patient to the FR2 during a battery insertion selftest the selftest will stop so that the FR2...

Страница 16: ...etailed periodic selftests to make sure that it remains ready for use See Appendix B for the environmental storage specifications While the FR2 is in the standby mode the Status Indicator shows the fl...

Страница 17: ...Placing and Securing the HEARTSTREAM FR2 2 6 Preparing Your HEARTSTREAM FR2 for Use Notes...

Страница 18: ...eath the protective backing To work effectively the gel must not be dried out It may be necessary to dry the patient s chest or to clip or shave excessive chest hair to provide good contact between th...

Страница 19: ...king from the defibrillation pads and check that the gel has not dried out If the pads are damaged or the gel has dried out use a new set of pads Place each pad on the patient The pads must be placed...

Страница 20: ...ere with background monitoring During CPR periodically pause for 15 seconds to check the patient and allow the FR2 to analyze the patient s heart rhythm without CPR artifact Monitoring continues until...

Страница 21: ...text prompts to guide you through additional shocks if appropriate NOTE If you do not press the Shock button within 30 seconds of being prompted the FR2 will disarm itself and provide a pause for CPR...

Страница 22: ...Do not use dried out defibrillation pads WARNING Handling or transporting the patient during heart rhythm analysis can cause an incorrect or delayed diagnosis If the HEARTSTREAM FR2 gives a SHOCK ADV...

Страница 23: ...Step 3 Shock Delivery 3 6 Using Your HEARTSTREAM FR2 Notes...

Страница 24: ...tem In addition a detailed selftest is run whenever a battery is installed in the FR2 The HEARTSTREAM FR2 requires no calibration or verification of energy delivery The HEARTSTREAM FR2 has no user ser...

Страница 25: ...and run the selftests DO NOT ATTEMPT TO CHARGE THE M3863A BATTERY It is not rechargeable If supplies accessories or spares are damaged or have expired Do not use damaged or expired accessories Replac...

Страница 26: ...d cleaners Glutaraldehyde based cleaners Hydrogen peroxide CAUTION Do not immerse any portion of the HEARTSTREAM FR2 in water or other fluids Do not allow fluids to enter the HEARTSTREAM FR2 Avoid spi...

Страница 27: ...ID __________________________________________________________________ DATE SCHEDULED FREQUENCY HEARTSTREAM FR2 Clean no dirt or contamination no signs of damage Supplies Available Two sets defibrillat...

Страница 28: ...circumstances the behavior of your FR2 will be different For example the menu screen will not appear when a battery is inserted if the defibrillation pads are attached to a patient indicating that the...

Страница 29: ...2 is ready for use During the automatic part of the selftest the screen displays a bar that fills in as the test continues When that part of the test is finished the HEARTSTREAM FR2 beeps The results...

Страница 30: ...thing does not work correctly for example if lights do not come on or you do not hear beeps when expected make a note of the problem and contact Agilent Technologies NOTE Do not use the HEARTSTREAM FR...

Страница 31: ...D Check the test pattern displayed on the screen Adjust the contrast if desired using the Option buttons NOTE Screen contrast can be adjusted at any time during the interactive selftest by repeatedly...

Страница 32: ...n in the left column of numbers and the total time in minutes it has been used shown in the right column of numbers SHOCKS the total number of shocks it has delivered TRAINING how many times it has be...

Страница 33: ...sponses to problems that may occur during use and provide recommendations for how to resolve them Although there is some overlap in the information presented for ease of reference the tables separatel...

Страница 34: ...le 3 Turn on the device by pressing the On Off button 4 Follow the voice prompts In some instances for example if the battery power is low and you do not have a spare battery available it may not be p...

Страница 35: ...with a spare battery if available 3 Turn on the device by pressing the On Off button 4 Follow the voice prompts In this condition the FR2 may not perform to its specifications However if voice and sc...

Страница 36: ...all the battery and perform the battery insertion selftest If it fails install a new battery and repeat the test If it fails again contact Agilent Technologies for technical support Make sure defibril...

Страница 37: ...completion of a selftest that fails The code can be redisplayed by pressing the On Off button NOTE You can stop the battery insertion selftest to use the FR2 as soon as you see the Status Indicator c...

Страница 38: ...or Training Administration Pack the FR2 turns off Replace the battery with a new battery or the Training Administration Pack with a fully charged Pack immediately OTHER SIGNAL POSSIBLE CAUSE RECOMMEN...

Страница 39: ...maged The FR2 has detected a possible defect in the defibrillation pads or cable Replace the defibrillation pads with new HEARTSTREAM defibrillation pads OTHER SIGNAL POSSIBLE CAUSE RECOMMENDED ACTION...

Страница 40: ...sitioned on the patient Make sure the defibrillation pads connector is completely inserted in the connector socket Press the defibrillation pads firmly to the patient s chest Replace the defibrillatio...

Страница 41: ...Troubleshooting Guide 4 18 Maintaining Testing and Troubleshooting Your HEARTSTREAM FR2 Notes...

Страница 42: ...ng in basic life support advanced life support or other physician authorized emergency medical response The HEARTSTREAM FR2 is not intended for administration of energy at pediatric energy settings In...

Страница 43: ...SAFETY LEVEL POSSIBLE SHOCK OR FIRE HAZARD OR EXPLOSION DANGER THERE IS A POSSIBILITY OF EXPLOSION IF THE HEARTSTREAM FR2 IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS OR CONCENTRATED OXYGEN DANGER...

Страница 44: ...before the expiration date shown on the package Do not reuse the defibrillation pads Discard them after use CAUTION Aggressive handling of the pads in storage or prior to use can damage the pads Disca...

Страница 45: ...hythms WARNING Handling or transporting the patient during heart rhythm analysis can cause an incorrect or delayed diagnosis If the HEARTSTREAM FR2 gives a SHOCK ADVISED prompt keep the patient as sti...

Страница 46: ...nostic and ST segment interpretation SAFETY LEVEL POSSIBLE FIRE OR SHOCK HAZARD CAUTION Electrical shock hazard Dangerous high voltages and currents are present Do not open the HEARTSTREAM FR2 remove...

Страница 47: ...Safety Considerations 5 6 Clinical and Safety Considerations Notes...

Страница 48: ...r FR2 and how the different parameter settings affect the way the device works Non Protocol Parameters The parameters listed in the following table enable features of FR2 operation that are not relate...

Страница 49: ...2 s periodic selftests PST from its infrared communications port ECG OUT ON OFF OFF Enables ON or disables OFF ECG data transmission from the infrared communications port of the FR2 ECG data can be se...

Страница 50: ...O SHOCK ADVISED NSA decision MONITOR directs the FR2 to monitor the patient s ECG following an NSA decision and to prompt the user periodically to provide CPR The interval for CPR prompting is set by...

Страница 51: ...mpts provided during FR2 monitoring of the patient s ECG following an NSA decision Selection of infinite means that no repeat prompting will be provided during ECG monitoring PARAMETER SETTINGS DEFAUL...

Страница 52: ...the lower Option button indicated by an arrow on the FR2 display as shown in the sample screen RESUME KEY ON OFF OFF Enables ON or disables OFF user initiated interruption of the CPR pause and return...

Страница 53: ...onnected Be sure to unplug the pads connector from the FR2 after each use Do not store the FR2 with the pads connected 2 Within 10 seconds of installing the battery press the lower Option button to mo...

Страница 54: ...ce operation resulting from changes to the default settings should be specifically covered in user training See the tables describing the various setup parameters at the beginning of this chapter See...

Страница 55: ...ware Reading Setup This method copies setup data from a data card to your HEARTSTREAM FR2 To read the setup follow these steps 1 Insert the data card in the data card tray and install the loaded tray...

Страница 56: ...rom the CLOCK screen of the receiving FR2 7 A new screen comes up Until the two HEARTSTREAM FR2 devices are properly positioned the screen on the receiving FR2 displays READY TO RECEIVE and prompts yo...

Страница 57: ...that include responders who have Basic Life Support BLS training as well as more highly trained responders who may be certified in Advanced Life Support ALS In such situations the Medical Director ma...

Страница 58: ...the HEARTSTREAM FR2 does not analyze and prompt if a shock is advised It is important that you understand that entering the advanced mode entails taking responsibility for these functions If the rhyth...

Страница 59: ...egins the screen message changes to CHARGING STAND CLEAR and the label for the arrowhead pointing to the upper Option button changes to MANUAL DISARM The FR2 beeps while it is charging When the beepin...

Страница 60: ...nformation from a data card Recording Incident Data The HEARTSTREAM FR2 has two ways of recording information about an emergency incident so it can be reviewed after the incident in internal memory an...

Страница 61: ...t it be replaced after each use of the HEARTSTREAM FR2 If you record information from more than one incident on a data card it is important to review how much time is left on the used data card before...

Страница 62: ...FR2 lasted and how many shocks were delivered during the incident This information stays in the HEARTSTREAM FR2 s memory and can be displayed for review until the next time the HEARTSTREAM FR2 is use...

Страница 63: ...ised setup allowing advanced mode operation 6 To review the first six seconds of the recorded presenting ECG for the incident select REVIEW ECG A new screen comes up This screen displays a three secon...

Страница 64: ...r with power cord for use with M3864A Training Administration Pack only 68 PCHAT Fast Response Kit pouch containing a pocket mask a disposable razor 2 pairs of gloves a pair of paramedics scissors and...

Страница 65: ...Accessories A 2 Notes...

Страница 66: ...GORY NOMINAL SPECIFICATIONS Operating Temperature and Humidity 32 to 122 F 0 to 50 C 0 to 95 relative humidity non condensing Standby Temperature and Humidity 32 to 109 F 0 to 43 C 0 to 75 relative hu...

Страница 67: ...s the peak voltage and Vf the final voltage The HEARTSTREAM FR2 delivers shocks to load impedances from 25 to 180 ohms The duration of each phase of the waveform is dynamically adjusted based on deliv...

Страница 68: ...is not delivered within 30 s after the FR2 is armed OR the On Off button is pressed to turn off the FR2 OR the defibrillation pads are removed from the patient or the pads connector is disconnected f...

Страница 69: ...r fibrillation 300 Meets AAMI DF39 requirement and AHA recommendationb sensitivity 90 for adult defibrillation Shockable Rhythm ventricular tachycardia 100 Meets AAMI DF39 requirement and AHA recommen...

Страница 70: ...andwidth Nondiagnostic rhythm monitor 1 Hz to 20 Hz 3 dB nominal Sensitivity 1 16 cm mV nominal Heart Rate Displayed Normal Sinus Rhythm 30 to 300 bpm updated each analysis period Displayed M3860A onl...

Страница 71: ...shocks or 12 hours operating time at 77 F 25 C Shelf Life prior to Installation Typically 5 years from date of manufacture when stored under standby environmental conditions in original packaging Sta...

Страница 72: ...d an optional Training Administration pack with an integrated rechargeable battery and separate charger Other improved features in the FR2 are more subtle such as facilitation of patient hand off in t...

Страница 73: ...ion Requires Training Administration Pack uses integrated rechargeable battery Battery Charger available separately Setup transfer Infrared transfer of setup data PANEL LAYOUT AND CONTROLS Display LCD...

Страница 74: ...aining Administration Pack is being used in the Training function this button is used to select and exit training scripts Shock button Delivers shock to patient when the HEARTSTREAM FR2 is charged Upp...

Страница 75: ...d since the last automatic self test SETUP Setup Setup has been lost from memory factory default setup is being used Contact Medical Director for revised setup REV XXXXXXXXX Software The version of so...

Страница 76: ...Pack Symbols SYMBOL DESCRIPTION Do not crush the battery Do not expose the battery to high heat or open flames Do not incinerate the battery Do not mutilate the battery or open the battery case Insta...

Страница 77: ...Symbols and Controls D 4 Notes...

Страница 78: ...Advanced Life Support Analysis See SMART Analysis Arrhythmia An unhealthy often irregular beating of the heart Battery The sealed lithium manganese dioxide battery used to power the FR2 It is provided...

Страница 79: ...art is associated with sudden cardiac arrest Heart Rhythm ECG Analysis A system used by the FR2 to determine if the patient s heart rhythm is shockable ventricular fibrillation VF or certain ventricul...

Страница 80: ...the responder through use of the HEARTSTREAM FR2 to treat the patient Protocol A sequence of operations performed by the HEARTSTREAM FR2 to direct patient care in the AED mode Protocol Timeout A progr...

Страница 81: ...t is an impedance compensated biphasic waveform with 150 Joules nominal delivered to a 50 ohm load Specificity A measure of the ability of the HEARTSTREAM FR2 to reliably detect and identify non shock...

Страница 82: ...VF as the initial monitored rhythm that were defibrillated in the first series of three shocks or fewer Methods Victims of out of hospital SCA were prospectively enrolled in four emergency medical ser...

Страница 83: ...rvival discharge were not significantly different statistically However patients resuscitated with the lower energy SMART Biphasic waveform were more likely to have good cerebral performance CPC cereb...

Страница 84: ...arnings and dangers 5 2 charge disarming B 3 time from Shock Advised B 2 chirping 4 12 4 13 4 14 cleaning agents to use 4 3 guidelines 4 3 clinical summary F 1 clock receiving settings 2 3 6 9 sending...

Страница 85: ...nce definition E 2 incident data definition of data on data card 7 3 definition of internal memory data 7 3 reviewing from data card 7 3 reviewing from internal memory 7 3 incident definition E 2 indi...

Страница 86: ...y 4 1 monthly 4 1 periodic 2 5 4 1 sensitivity definition E 3 setup definition E 4 reading setup 6 8 receiving setup 6 7 shock see SMART biphasic waveform Shock button description of use D 1 shock ser...

Страница 87: ...erating B 1 standby B 1 tiered response features 6 9 Training Administration Pack battery charger A 1 description E 4 troubleshooting 4 10 U user qualifications and training 1 2 W warnings cautions an...

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