Philips HeartStart FR2+ Instructions For Use Manual Download Page 84

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M3860A/M3861A HEARTSTART FR2+

C-6

ili

dic

tem

M3849A charger
for the M3848A FR2+ rechargeable battery

Refer to operating instructions.

Lithium manganese dioxide battery chemistry (M3863A)

Lithium ion battery chemistry (M3848A)

12 volts direct current output.

Insert into FR2+ in this direction.

Meets the requirements of the European medical device
directives.

Fragile.

Protect from moisture.

Contains one battery.

Printed on recycled paper.

symbol

description

Refer to operating instructions.

symbol

description

Summary of Contents for HeartStart FR2+

Page 1: ...P O W E R T O S A V E A L I F E M3860A M3861A Edition 10 H E A R T S T A R T F R 2 D E F I B R I L L A T O R I N S T R U C T I O N S F O R U S E ...

Page 2: ...or data card tray Data card optional Used to store and review information about an 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 help seal the FR2 against fluids The tray should be kept installed in the FR2 even if no data card is used Microphone Used optionally to record surrounding audio during an in...

Page 3: ...P h i l i p s M e d i c a l S y s t e m s H E A R T S T A R T F R 2 D E F I B R I L L A T O R Q U I C K R E F E R E N C E C A R D ...

Page 4: ...P h i l i p s M e d i c a l S y s t e m s Intentionally left blank ...

Page 5: ...P h i l i p s M e d i c a l S y s t e m s H E A R T S T A R T F R 2 M3860A M3861A Defibrillator I N S T R U C T I O N S F O R U S E Edition 10 ...

Page 6: ...rs and operators alike Philips Medical Systems reserves the right to make changes in specifications or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication Authorized EU Representative Philips Medizinsysteme Boeblingen GmbH Hewlett Packard Strasse 2 71034 Boeblingen Germany 49 7031 14 5151 CAUTION...

Page 7: ...Using Your HeartStart FR2 Overview 3 1 Step 1 Preparation 3 2 Step 2 ECG Analysis and Monitoring 3 3 Step 3 Shock Delivery 3 4 ECG Display for Ongoing Observation 3 5 4 Maintaining Testing and Troubleshooting Your HeartStart FR2 Overview 4 1 Maintenance 4 1 After Using the HeartStart FR2 4 2 Cleaning the HeartStart FR2 4 3 Operator s checklist 4 3 Testing 4 5 Battery insertion selftest 4 5 Periodi...

Page 8: ...ol parameters 6 1 Automatic protocol parameters 6 2 Manual override parameters 6 4 Using Setup Features 6 5 Reviewing current setup 6 6 Revising setup 6 6 Receiving setup 6 7 Reading setup 6 8 Sending and Receiving Clock Settings 6 8 Using Advanced Mode Features 6 9 Using the manual analyze feature 6 10 Using the manual charge feature M3860A only 6 11 7 Data Management and Review Overview 7 1 Reco...

Page 9: ...s A 1 Suggested Additional Items A 2 B Technical Specifications HeartStart FR2 Defibrillator Specifications B 1 Accessories Specifications B 6 C Glossary of Symbols and Controls Instructions for Use C 1 HeartStart FR2 M3860A and M3861A Defibrillator Symbols and Controls C 1 Accessories Symbols C 3 D Glossary of Terms Index ...

Page 10: ...M3860A M3861A HEARTSTART FR2 P h i l i p s M e d i c a l S y s t e m s Notes ...

Page 11: ...hat is always active so you can tell at a glance if it is ready for use The front panel of the FR2 has an On Off button at the top and a Shock button at the bottom A display screen in the center of the panel provides text prompts and incident information Voice prompts are provided through a speaker located at the base of the FR2 See the diagram on the inside front cover for details The FR2 is avai...

Page 12: ...sed with the FR2 ECG assessment module to display the rhythm of a responsive or breathing patient regardless of age The FR2 Defibrillator used with the FR2 ECG assessment module provides a non diagnostic display for attended patient monitoring While connected to the FR2 ECG assessment module the FR2 displays and evaluates the patient s ECG and disables its shock capability How Does the HeartStart ...

Page 13: ... life battery two sets of adult defibrillator pads with integrated cable and connector and a data card tray Other accessories including an FR2 rechargeable battery FR2 infant child reduced energy defibrillator pads and for M3860A only with ECG display enabled a three wire FR2 ECG assessment module are available See Appendix A for a list of accessories and other recommended supplies ...

Page 14: ...P h i l i p s M e d i c a l S y s t e m s M3860A M3861A HEARTSTART FR2 Notes ...

Page 15: ...or is shipped with a M3863A standard long life battery The battery is enclosed in a gray plastic case There is a yellow latch at one end that holds the battery in place when it is correctly installed in the FR2 The optional M3848A FR2 rechargeable battery is enclosed in a blue plastic case and also has a yellow latch Except where otherwise noted the following information applies to both battery ty...

Page 16: ...standard battery unless otherwise noted NOTE This screen will not be displayed if the FR2 is connected to defibrillator pads that are applied to the patient when the battery is inserted and you will not be able to access the menu items In addition the battery insertion selftest and periodic automatic selftests cannot run while the defibrillator pads are connected to the patient Be sure to unplug t...

Page 17: ...ion button to move the highlight bar to NEXT 2 Press the upper Option button to bring up the NEXT screen 3 Press the lower Option button to move the highlight bar to CLOCK 4 Press the upper Option button to bring up the CLOCK screen The CLOCK screen displays the date and time currently set in the internal clock of the FR2 NOTE The date is displayed as day DD month MM and year YY as shown on the sc...

Page 18: ...ugh not displayed are set to 00 when you move the highlight bar out of the time settings NOTE If the battery is removed from the FR2 for more than two hours the clock settings will be lost and must be reset Running the Battery Insertion Selftest Except in an emergency it is recommended that you run this selftest every time you change the battery Make sure the defibrillator pads are not connected t...

Page 19: ... recent self test and is therefore ready for use simply by pressing the On Off button to turn it on Placing and Securing the HeartStart FR2 Place the HeartStart FR2 Defibrillator in an accessible area with the Status Indicator easily visible Useful accessories for placing and securing the FR2 include a carrying case which is suitable for use with a wall mount bracket or defibrillator cabinet See A...

Page 20: ...P h i l i p s M e d i c a l S y s t e m s M3860A M3861A HEARTSTART FR2 Notes ...

Page 21: ...gel beneath the protective backing To work effectively the gel must not be dried out It may be necessary to dry the patient s skin or to clip or shave excessive chest hair to provide good contact between the defibrillator pads and the patient s skin The following pages provide step by step instructions for normal use of the FR2 in an emergency See Chapter 4 Maintaining Testing and Troubleshooting ...

Page 22: ...ee that the pads and attached cable and connector are undamaged Pull off the protective backing from the defibrillator 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 with the sticky side on the patient s skin IMPORT ANT Refer to the drawing on each pad for correct positioning...

Page 23: ...NOTE CPR may interfere 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 and unless the FR2 detects a change in the patient s heart rhythm that may be a shockable rhythm detects interference with rhythm analysis or is turned off If the FR2 detects a pot...

Page 24: ... prompted the FR2 will disarm itself and provide a pause The device will resume analyzing after 30 seconds or when the Resume Analyzing key is pressed Pause for CPR After the programmed number of shocks in a shock series are delivered the FR2 automatically pauses for a programmed amount of time to allow you to perform CPR After the voice and screen prompts tell you that the FR2 has paused there ar...

Page 25: ...e s device connector is inserted in the FR2 s connector socket NOTE It is not necessary to turn the FR2 Defibrillator off prior to connecting the ECG assessment module Once connected the FR2 displays and evaluates the patient s ECG Lead II Follow all prompts from the FR2 If a data card is used when the module is connected to the FR2 all recorded events can be viewed using HeartStart Event Review d...

Page 26: ...ibrillating current away from the heart WARNING Handling or transporting the patient during heart rhythm analysis can cause an incorrect or delayed diagnosis If the FR2 gives a SHOCK ADVISED prompt keep the patient as still as possible for at least 15 seconds so the FR2 can reconfirm the rhythm analysis before a shock is delivered WARNING CPR rates significantly above 100 compressions per minute c...

Page 27: ...stalled in the FR2 The FR2 requires no calibration or verification of energy delivery The FR2 has no user serviceable parts CAUTION Improper maintenance may damage the FR2 or cause it to function improperly Maintain the FR2 only as described in this User s Guide or as designated by your program s Medical Director CAUTION Electrical shock hazard Dangerous high voltages and currents are present Do n...

Page 28: ...task response Check the Status Indicator If you see the flashing black hourglass The FR2 is ready to use No action required If you see anything other than a flashing black hourglass remove and reinstall the battery to run the selftest If the selftest passes and the Status Indicator shows the flashing black hourglass the FR2 is ready to use If the selftest fails install a new battery and run the se...

Page 29: ...ymatic cleaners Clean the FR2 and the connector socket with a soft cloth dampened with one of the cleaning agents listed below Isopropyl alcohol 70 solution Soapy water Chlorine bleach 30 ml l water Ammonia based cleaners Glutaraldehyde based cleaners Hydrogen peroxide CAUTION Do not immerse any portion of the FR2 in water or other fluids Do not allow fluids to enter the FR2 Avoid spilling any flu...

Page 30: ...ency HeartStart FR2 Clean no dirt or contamination no signs of damage Supplies Available Two sets defibrillator pads sealed undamaged within expiration date Ancillary supplies hand towel scissors razor pocket mask gloves Spare M3863A battery within Install Before date Data cards undamaged and spare data card tray Status Indicator Shows alternating hourglass square selftest passed Inspected by Sign...

Page 31: ...en you insert the battery a menu is displayed and a two part selftest will run unless you make another selection from the menu within 10 seconds The selftest includes an automatic part and an interactive part NOTE Under certain circumstances the behavior of your FR2 will be different For example the menu screen will not appear when a battery is inserted if the defibrillator pads are attached to a ...

Page 32: ...reen displays a message that the FR2 must pass a selftest before being used It is recommended that you always have a spare battery available However if a screen display prompts you to replace the battery or the Status Indicator shows a flashing red X but you do not have a spare battery you can continue to use the FR2 until the battery is completely depleted This may be necessary in an emergency NO...

Page 33: ...ts and speaker on the FR2 are working properly Screen prompts guide you through a series of steps in the interactive part of the selftest Some ask you to observe that a feature of the FR2 works properly Others ask you to take certain actions for example to press a button The screen then displays a message showing that the button s operation has been verified If you do not press the button or if yo...

Page 34: ...on buttons and listen for a beep to confirm each press Look at the screen to be sure the button presses have been verified display screen Screen prompt CHECK DISPLAY ADJUST CONTRAST IF NEEDED 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 pressing t...

Page 35: ...hing red X or a solid red X on the Status Indicator Device history The FR2 stores key information about its history in internal memory To review the history of your FR2 select NEXT from the menu screen displayed when you insert the battery then select DEVICE HISTORY from the next menu displayed The device history information is read from the internal memory of the FR2 It includes USES how many tim...

Page 36: ...creen displayed when you insert the battery then select BATTERY HISTORY from the next menu displayed The battery history information is read from the internal memory of the battery It includes USE MINUTES the total operating time in minutes including selftest time for this battery CHARGES the total number of full defibrillation charges that have been provided by this battery including selftest cha...

Page 37: ...k the device screen for text prompts NOTE After completing emergency use of the FR2 if you are unable to clear the problem as described in this Troubleshooting section and the Status Indicator does not show the flashing black hourglass contact Philips Medical Systems for technical support In the unlikely event that the device becomes unresponsive during use 1 cycle power press the On Off button on...

Page 38: ...LY or PLUG IN CONNECTOR Or voice prompts INSERT CONNECTOR FIRMLY or PRESS PADS FIRMLY TO PATIENT S BARE CHEST or POOR PADS CONTACT The defibrillator pads are not properly applied to the patient or are not making good contact with the patient s bare chest because of moisture or excessive hair or are touching each other The defibrillator pads connector is not firmly inserted in the connector socket ...

Page 39: ...ve them from the area Responders and bystanders should minimize motion particularly in dry environments that can generate static electricity Voice and screen prompts NO SHOCK DELIVERED The patient impedance is not appropriate for the FR2 to deliver a shock Make sure the defibrillator pads are correctly positioned on the patient according to the diagram on the back of the pads Make sure the defibri...

Page 40: ...fails install a new battery and repeat the test If it fails again do not use the FR2 Make sure defibrillator pads are not attached to the FR2 Status Indicator FLASHING OR SOLID RED X Audio signal CHIRPING Screen prompt displayed for 10 seconds at the end of a BIT before FR2 turns off NOT READY FOR USE or SELFTEST FAILED A test revealed a failure or error The FR2 performs self tests every time it i...

Page 41: ...e test If it fails again do not use the FR2 Status Indicator SOLID RED X Audio signal CHIRPING The training administration pack is being used in the ADMINISTRATION function and more than 10 minutes have passed without user interaction button press or pads change The training administration pack is being used in the TRAINING function and more than 30 minutes have passed without user interaction but...

Page 42: ...P h i l i p s M e d i c a l S y s t e m s M3860A M3861A HEARTSTART FR2 Notes ...

Page 43: ...n also be used with the FR2 ECG assessment module to display the rhythm of a responsive or breathing patient regardless of age There are no known contraindications to use of the FR2 ECG assessment module Contraindications The HeartStart FR2 is contraindicated for use should not be used on patients who show either of the following signs Responsiveness Presence of normal breathing Safety Considerati...

Page 44: ...HEARTSTART FR2 HAS NOT BEEN EVALUATED OR APPROVED FOR USE IN HAZARDOUS LOCATIONS AS DEFINED IN THE NATIONAL ELECTRICAL CODE ARTICLES 500 503 IN ACCORDANCE WITH THE IEC CLASSIFICATIONS SECTION 5 5 THE HEARTSTART FR2 IS NOT TO BE USED IN THE PRESENCE OF FLAMMABLE SUBSTANCE AIR MIXTURES DANGER DO NOT RECHARGE THE M3863A FR2 STANDARD BATTERY WARNING Use the HeartStart FR2 only as described in this man...

Page 45: ...lator pads Use the defibrillator pads before the expiration date shown on the package Do not reuse the defibrillator pads Discard them after use CAUTION Aggressive handling of the defibrillator pads in storage or prior to use can damage the pads Discard the defibrillator pads if they become damaged CAUTION Follow all instructions supplied with the M3863A FR2 standard battery Install the battery be...

Page 46: ... safety level possible shock hazard WARNING Defibrillation current can cause operator or bystander injury Do not touch the patient during defibrillation Disconnect the pads connector from the HeartStart FR2 before using any other defibrillator safety levels possible ECG misinterpretation WARNING For safety reasons some very low amplitude or low frequency heart rhythms may not be interpreted by the...

Page 47: ...possible patient injury CAUTION The HeartStart FR2 advanced mode s MANUAL CHARGE feature is intended for use only by authorized operators who have been specifically trained in cardiac rhythm recognition and in defibrillation therapy using manual charge and shock delivery safety level possible misinterpretation of ECG recordings CAUTION The LCD screen on the HeartStart FR2 model M3860A is intended ...

Page 48: ... s t e m s CAUTION Improper maintenance may damage the HeartStart FR2 or cause it to function improperly Maintain the HeartStart FR2 only as described in this User s Guide or as designated by your program s Medical Director safety level possible fire or shock hazard ...

Page 49: ...works Non protocol parameters The parameters listed in the following table enable features of FR2 operation that are not related to the patient treatment protocol The table describes each of these non protocol parameters lists the settings available for it and identifies the default setting parameter settings default description speaker volume 1 2 3 4 5 6 7 8 8 Sets volume of the FR2 s speaker 1 i...

Page 50: ...pause The length of the CPR pause after completion of a Shock Series is defined by the CPR Timer setting A new Shock Series begins when a shock is delivered after the FR2 is turned on after the automatic CPR pause or after the Pause Key if enabled has been pressed or if the time since the previous shock exceeds the Protocol Timeout setting protocol timeout minutes 0 5 1 0 1 5 2 0 2 5 3 0 3 5 infin...

Page 51: ...e length of the CPR pause is defined by the NSA Action time setting If shocks have been delivered in the current Shock Series e g the NSA decision follows a shock the length of the CPR pause is instead defined by the CPR Timer setting CPR prompt LONG SHORT LONG Sets the level of detail provided in the CPR reminder voice prompts provided at the completion of a Shock Series LONG provides detailed co...

Page 52: ...y when advance mode is entered CHARGE M3860A only in addition to enabling the analyze feature enables user initiated charging and disarming pause key OFF MONITOR ALWAYS OFF Enables or disables user initiated CPR pause in the automatic protocol The length of the pause is defined by the CPR Timer setting When an Advanced mode feature ANALYZE or CHARGE is enabled and accessed the Pause key is disable...

Page 53: ...ibrillator pads that are applied to the patient when the battery is inserted and you will not be able to access the menu items In addition the battery insertion selftest and periodic automatic selftests cannot run while the defibrillator pads are connected Be sure to unplug the pads connector from the FR2 after each use Do not store the FR2 with the pads connected resume key ON OFF OFF Enables ON ...

Page 54: ...derstand the setup of your FR2 is to review the setup it currently uses 1 Select REVIEW SETUP from the SETUP menu The first of a series of REVIEW SETUP screens is displayed 2 After reviewing the screen contents press the upper Option button to select NEXT and move to the next screen 3 The last screen allows you to select RETURN and go back to the SETUP menu Revising setup There are several ways to...

Page 55: ...etup directly from one HeartStart FR2 to another which must have the training administration pack installed in it or from a computer running HeartStart Event Review software See instructions provided with HeartStart Event Review To receive setup from another FR2 follow these steps 1 Locate the infrared communications port on each HeartStart FR2 and line them up with one another so that the infrare...

Page 56: ...ion from the data card immediately 4 If you select EXIT before the transfer is complete the revised setup will not be copied When the transfer is finished the screen displays a SETUP COMPLETE message Your FR2 immediately uses the revised setup Sending and Receiving Clock Settings To synchronize the clock settings of your HeartStart FR2 with the clock of another FR2 or a computer running HeartStart...

Page 57: ...ned Using Advanced Mode Features The HeartStart FR2 provides an advanced mode that allows responders who are appropriately trained to override the programmed FR2 protocol and take responsibility for certain aspects of the operating sequence used by the FR2 to treat the patient As described earlier in this chapter the factory default setup of the FR2 must be modified to provide access to advanced m...

Page 58: ...may set up a tiered response system The HeartStart FR2 is specifically designed to provide different product features appropriate to each tier of responder In a scenario where a BLS responder is the first on the scene of an incident he or she is trained to treat the patient immediately for example to check for breathing and responsiveness to apply the defibrillator pads and connect them to the Hea...

Page 59: ...a Shock Advised decision the FR2 begins charging prompts you to press the Shock button and displays a MANUAL DISARM option at the top of the screen If for any reason you want to cancel the shock press the upper Option button to disarm the FR2 To return to non manual AED mode operation turn the FR2 off by pressing the On Off button Then turn the FR2 on by pressing the On Off button again Using the ...

Page 60: ... 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 beeping changes to a continuous tone and the Shock button light flashes press the Shock button to deliver a shock However if the ECG display shows that the patient s rhythm has changed to a non shockable rhythm press the upper Option button to disarm...

Page 61: ...om a data card Recording Incident Data The HeartStart FR2 has two ways of recording information about an emergency incident so that it can be reviewed after the incident in internal memory and on an optional data card Recording data in internal memory Summary data for an incident is automatically recorded in internal memory by the FR2 while you are using it Recording data on a data card The M3854A...

Page 62: ...g out of data card space during an incident it is recommended that each data card be used to record the information for only one incident and that it be replaced after each use of the 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 recording a new incident To do this load the data card into the da...

Page 63: ...ata card tray into the port Reviewing Incident Data Reviewing data from internal memory Summary information from the last incident that is stored in the internal memory of the HeartStart FR2 can be displayed on its screen for review To review this information 1 Remove the data card if one is installed and unplug the pads connector 2 Remove and reinstall the battery Make sure you are using the gray...

Page 64: ... not contain event data only the summary information from FR2 internal memory will be displayed when REVIEW INCIDENT is selected 5 To review the events that occurred during the incident select REVIEW EVENTS A new screen comes up This and following screens accessed by selecting NEXT EVENTS display elapsed time information for critical activities in using the FR2 These include POWER ON when the FR2 ...

Page 65: ...resenting ECG for the incident select REVIEW ECG A new screen comes up This screen displays a three second segment of the presenting ECG from the incident 7 Select NEXT ECG SEGMENT to review the second three second segment of the presenting ECG Data cards can be reused if desired Using a personal computer running HeartStart Event Review software you can copy the information from a data card then e...

Page 66: ...P h i l i p s M e d i c a l S y s t e m s M3860A M3861A HEARTSTART FR2 Notes ...

Page 67: ...le for use only with an M3860A FR2 configured for ECG display for connection to ECG electrodes per AAMI M3873A or IEC M3874A convention M3864A training administration pack M3855A charger for the training administration pack only includes power cord PFE7023D PFE7024D defibrillator cabinets 07 10900 training pads YC hardshell waterproof carrying case The M3848A FR2 rechargeable battery is designed f...

Page 68: ...needed when an incident occurs Some suggested supplies include a pair of paramedic s shears or scissors a disposable razor designed for removing chest hair a pocket mask or face shield disposable gloves a towel or antiseptic wipes a source of oxygen Your medical director may have other requirements for supplies Contained in the fast response kit available from Philips Medical Systems ...

Page 69: ...kg with optional M3848A FR2 rechargeable battery installed category 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 humidity non condensing Applies to HeartStart FR2 with battery installed and stored with defibrillator pads Altitude Meets MIL 810E 500 3 P...

Page 70: ...load impedances from 25 to 180 ohms The duration of each phase of the waveform is dynamically adjusted based on delivered charge in order to compensate for patient impedance variations as shown below adult defibrillation load phase 1 phase 2 delivered resistance ohms duration ms duration ms energy J 25 2 8 2 8 140 50 4 09 4 09 150 100 9 0 6 0 157 125 12 0 8 0 161 150 12 0 8 0 157 pediatric defibri...

Page 71: ... Disease Control and Prevention 2000 Charge Control Controlled by Patient Analysis System for automated operation Can be programmed for manual initiation using advanced mode of the M3860A Charge Time from Shock Advised 10 seconds typical including confirming analysis Charge time increases near end of battery service life Shock to Shock Cycle Time 20 seconds typical including analysis in AED mode C...

Page 72: ...via FR2 infant child reduced energy defibrillator pads placed in the anterior posterior position category nominal specifications category nominal specifications Function Evaluates impedance of defibrillator pads for proper contact with patient skin and evaluates the ECG rhythm and signal quality to determine if a shock is appropriate Protocols Follows pre programmed settings to match local EMS gui...

Page 73: ...A only ECG information can also be displayed in the M3860A using the FR2 ECG assessment module NOTE The ECG display provided by the FR2 Defibrillator is not is not intended to provide diagnostic or ST segment interpretation Display Range M3860A only Differential 2 mV full scale nominal Screen Type High resolution liquid crystal display LCD with backlight Screen Dimensions 2 8 wide x 2 3 high 70 mm...

Page 74: ...icator Solid or flashing red X Status Indicator on front panel screen display LOW BATTERY or REPLACE BATTERY warning as appropriate category nominal specifications category nominal specifications Battery Type 12 VDC 4 2 Ah lithium manganese dioxide Disposable long life primary cell Capacity When new a minimum of 300 shocks or 12 hours of operating time at 77 F 25 C Shelf Life prior to installation...

Page 75: ...f the FR2 Storage Temperature 32 to 109 F 0 to 43 C Standby Life after installation 6 months when installed fully charged in a defibrillator labeled FR2 category nominal specifications Application For use with M3848A FR2 rechargeable battery only Power Requirements 100 to 240 VAC 47 to 63 Hz 30 Watts Environmental Requirements 32 to 122 F 0 to 50 C 0 to 95 relative humidity non condensing Conforma...

Page 76: ...ns Battery Type 12 V 1 1 Ah nickel metal hydride Disposable rechargeable cell using the M3855A charger Capacity Provides 4 hours of operating time at 77 F 25 C Status Indicators Low battery flashing red X on the front panel of the FR2 Dead battery solid red X on the front panel of the FR2 Storage Temperature 50 to 104 F 10 to 40 C category nominal specifications Application For use with M3864A tra...

Page 77: ...ature and Humidity 32 to 109 F 0 to 43 C 0 to 75 relative humidity non condensing Patient Lead Wire Designation M3873A AAMI M3874A IEC positive lead red positive lead green negative lead white negative lead red reference lead black reference lead yellow Typical Lead II Connection Lead II vectors positive left leg negative right arm reference left arm Other limb vectors can be obtained by different...

Page 78: ...P h i l i p s M e d i c a l S y s t e m s M3860A M3861A HEARTSTART FR2 Notes ...

Page 79: ...f button Turns the HeartStart FR2 on or off disarms HeartStart FR2 stops automatic self test When the optional training 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 HeartStart FR2 is charged Upper and lower Option buttons Allow you to move around in and select an item from a displa...

Page 80: ...y installed meets IEC 529 class IP54 symbol description HR XXX Heart rate XX Number of shocks delivered XX XX Time How much time minutes seconds has passed since the HeartStart FR2 was turned on TEMPERATURE Temperature Recommended storage temperature range has been exceeded since the last battery insertion self test SETUP Setup Setup has been lost from memory factory default setup is being used Co...

Page 81: ... Maintaining Testing and Troubleshooting Your HeartStart FR2 Flashing red X Troubleshooting required See Chapter 4 Maintaining Testing and Troubleshooting Your HeartStart FR2 symbol description These pads are disposable and are for single patient use only Pouch contents one pair of defibrillator pads Store the pads at temperatures between 0 and 43 C 32 and 110 F Refer to operating instructions Non...

Page 82: ...lts DP2 DP6 For use with Philips Heartstream HeartStart and Laerdal HeartStart ForeRunner FR and FR2 AEDs DP2 DP6 Not for use with Laerdal HeartStart models 911 1000 2000 3000 DP2 DP6 Pad placement for infants and children younger than 8 years or lighter than 55 pounds 25 Kg M3870A Meets the requirements of the EMC directives DP2 DP6 Meets the requirements of the European medical device directives...

Page 83: ...attery Box contents 2 pouches DP2 Box contents 6 pouches DP6 This side up Fragile Protect from moisture Printed on recycled paper symbol description Do not crush Do not expose to high heat or open flames Do not incinerate Do not mutilate or open Install before the date shown on this label Date format is MM YYYY symbol description 2 6 ...

Page 84: ...Lithium manganese dioxide battery chemistry M3863A Lithium ion battery chemistry M3848A 12 volts direct current output Insert into FR2 in this direction Meets the requirements of the European medical device directives Fragile Protect from moisture Contains one battery Printed on recycled paper symbol description Refer to operating instructions symbol description ...

Page 85: ...cator Charger status indicator Meets the requirements of the EMC directives This product has passed relevant safety tests by CSA a nationally recognized test lab This product has been certified by the Australian Communication Authority Printed on recycled paper Electrical input Electrical output symbol description N11695 V00341 ...

Page 86: ...symbol description Use the cable and electrodes before the respective dates shown on this label Ship and store the product within the temperature ranges shown Place the electrodes as shown Meets the requirements of the EMC directives Lot number Refer to operating instructions Printed on recycled paper symbol description Refer to operating instructions ...

Page 87: ... or open Nickel metal hydride battery chemistry 12 volts direct current output Insert into FR2 in this direction Meets the requirements of the EMC directives Kit contains Training Administration Pack Instructions for Use and set of training pads Ship and store the product within the temperature ranges shown This side up Fragile Protect from moisture symbol description ...

Page 88: ...training administration pack Printed on recycled paper symbol description Refer to operating instructions High voltage Protect from moisture On Off indicator Charger status indicator Meets the requirements of the EMC directives Electrical input Electrical output Printed on recycled paper symbol description ...

Page 89: ...nd rechargeable battery BLS Basic Life Support continued use A condition in which use of the HeartStart FR2 is interrupted for less than five minutes e g for battery replacement When the battery is reinserted or the unit is turned on again the information stored about the interrupted incident is saved any additional events recorded after the battery is reinstalled are treated as part of the same i...

Page 90: ...re system formerly sold as CodeRunner for use with the HeartStart FR2 It is available from Philips Medical Systems on CD or on the world wide web at http www medical philips com goto eventreview impedance Electrically this is the total opposition offered by the body to the flow of the electrical shock waveform delivered by the HeartStart FR2 The FR2 automatically monitors the electrical impedance ...

Page 91: ...l circuitry presenting ECG The heart rhythm seen by the HeartStart FR2 when it is first connected to the patient via the defibrillator pads and begins rhythm analysis prompts The voice commands and screen text used to guide the responder through use of the HeartStart FR2 to treat the patient protocol A sequence of operations performed by the HeartStart FR2 to direct patient care in the AED mode pr...

Page 92: ...hasic waveform SMART analysis The proprietary algorithm used by the FR2 to analyze the patient s heart rhythm and determine whether a shock is advised SMART biphasic waveform The patented low energy defibrillation shock waveform used by the FR2 It is an impedance compensated biphasic waveform with 150 Joules nominal delivered to a 50 ohm load When delivered via FR2 infant child reduced energy defi...

Page 93: ...ck An optional accessory for the FR2 that enables training and administrative functions The integral battery should be charged only using the M3855A charger waveform See SMART biphasic waveform write data A feature of the HeartStart FR2 that allows it to record setup information on a data card ...

Page 94: ...P h i l i p s M e d i c a l S y s t e m s M3860A M3861A HEARTSTART FR2 Notes ...

Page 95: ...6 10 manual charge 6 11 6 12 D 2 manual disarm 6 12 D 2 programmable settings 6 4 tiered response features 6 9 user qualifications 6 9 AED mode definition D 1 AED definition D 1 ALS definition D 1 applying to child patient 3 2 arrhythmia definition D 1 asystole detection B 4 autosend PST definition 6 1 programmable settings 6 1 B battery description 2 1 D 1 insertion selftest 2 4 replacing during ...

Page 96: ...llation definition D 1 defibrillator specifications B 2 defibrillator pads applying to adult patient 3 2 applying to patient 3 2 checking before use 3 2 connecting to the FR2 3 2 damage during CPR 3 6 description D 1 positioning correctly 3 2 specifications B 7 device history description of data 4 9 reviewing 4 9 disarming the FR2 in advanced mode B 4 in AED mode B 3 manual 6 12 B 4 display screen...

Page 97: ...definition of data on data card 7 4 definition of internal memory data 7 3 reviewing from data card 7 4 reviewing from internal memory 7 3 incident definition D 2 indications and contraindications 1 2 5 1 infrared communications description D 2 receiving setup 6 6 installing the battery 2 1 L LCD display see display screen M M3848A rechargeable battery A 1 B 7 M3849A charger for M3848A rechargeabl...

Page 98: ...6 4 programmable settings 6 4 pause definition D 3 pause time indication 3 4 pediatric defibrillation choosing defibrillator pads 3 2 periodic selftests definition D 3 description 4 9 frequency 4 1 Status Indicator alerts 4 9 presenting ECG definition D 3 description 7 5 prompt interval monitor settings 6 5 prompt intervals advanced use settings 6 5 definition 6 5 prompts definition D 3 protocol t...

Page 99: ...vector B 4 shock waveform B 2 specification B 2 solid red X see Status Indicator speaker volume definition 6 1 programmable settings 6 1 specifications battery B 6 controls and indicators B 5 defibrillator B 2 defibrillator pads B 7 display screen B 5 ECG analysis performance B 5 ECG analysis system B 4 environmental B 1 physical B 1 specificity definition D 4 standby mode definition D 4 standby t...

Page 100: ...ating B 1 standby B 1 tiered response features 6 9 training administration pack charger A 1 description D 5 troubleshooting 4 11 U user qualifications and training 1 2 W warnings cautions and dangers 5 2 waveform see SMART biphasic waveform X X Status Indicator flashing or solid 4 11 solid 4 11 ...

Page 101: ...P h i l i p s M e d i c a l S y s t e m s Intentionally left blank ...

Page 102: ...llmount Road Markham Ontario L6C 2S3 Canada 800 291 6743 Europa Midt Østen og Afrika Philips Medizinsysteme Boeblingen GmbH Hjerte og overvåkingssystemer Hewlett Packard Strasse 2 71034 Boeblingen Tyskland 49 7031 463 1552 Latin Amerika Philips Medical Systems 1550 Sawgrass Corporate Parkway Suite 300 Sunrise FL 33323 USA 954 835 2660 Stillehavslandene i Asia Philips Electronics Hong Kong Ltd 30th...

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Philips HeartStart FR2+, Instructions For Use Manual

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