Page 1
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 M3860A, M3861A Edition 10...
Page 2
Status Indicator. Shows you the readiness status of the FR2+. Display screen. Displays text prompts and incident data. The FR2+ M3860A screen also displays the patient’s ECG. Option buttons. Adjust the contrast of the screen display and control special functions.
Page 3
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 5
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
FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. The HeartStart FR2+ is designed to be used only with Philips- approved accessories. The HeartStart FR2+ may perform improperly if non-approved accessories are used.
Contents 1 Introduction to the HeartStart FR2+ What is the HeartStart FR2+? ... When Is the HeartStart FR2+ Used? ... How Does the HeartStart FR2+ Work? ... How Is the HeartStart FR2+ Supplied? ... 2 Preparing Your HeartStart FR2+ for Use Overview ...
Page 8
Reading setup ... Sending and Receiving Clock Settings ... Using Advanced Mode Features ... Using the manual analyze feature ... 6-10 Using the manual charge feature (M3860A only) ... 6-11 Overview ... Recording Incident Data ... Recording data in internal memory ...
Page 9
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...
FR2+. (See the diagram on the inside front cover for details.) The FR2+ is available in two models, the M3860A and the M3861A. They share a set of basic features, detailed in Chapter 6. The principle differences...
Basic Life Support (BLS), in Advanced Life Support (ALS), or in other physician-authorized emergency medical response. At the discretion of emergency care personnel, the M3860A FR2+ with ECG display enabled can also be used with the FR2+ ECG assessment module to display the rhythm of a responsive or breathing patient, regardless of age.
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.
Preparing Your HeartStart FR2+ for Overview There are a few basic steps to preparing your HeartStart FR2+ Defibrillator for use: Install data card (optional). Install a battery. Set the clock in the FR2+ (optional). Run the battery insertion selftest. Place the FR2+ with recommended accessories in a convenient location.
Page 16
Chapter 6, “Setup and Advanced Mode Features, ” for information on the setup option.) M3860A/M3861A HEARTSTART FR2+ This screen will not be displayed if the FR2+ is connected to To move around the menus displayed, use the Option buttons as...
If you make no selection for 10 seconds, the selftest will N O T E automatically run. If you want to select something different from either of these menus, you must do so before the selftest begins, or remove and reinstall the battery to bring up the main menu.
1. Make sure the defibrillator pads are not connected to the device. 2. Insert the battery into the battery port. The first screen displayed has M3860A/M3861A HEARTSTART FR2+ clock setting you want to change. until you reach the one you want. If you go past it, keep scrolling until it comes up again.
3. Press the upper Option button to activate the test. make no selection for 10 seconds, and the selftest will start automatically if the FR2+ has been turned off for at least 5 minutes. If you connect defibrillator pads (that are applied to the patient) to N O T E the FR2+ during a battery insertion selftest, the selftest will stop and the FR2+ will go to its standby mode to be ready for use.
Be sure to read the Warnings and Cautions on the last page I M P O R T A N T of this chapter. These directions apply to both the model M3860A and the model N O T E M3861A FR2+, except where otherwise noted.
Connect the pads to the FR2+. Insert the defibrillator pads connector firmly into the connector socket. A flashing light shows you where the socket is located, at the top left of the FR2+. M3860A/M3861A HEARTSTART FR2+ ’ S EXACT AGE...
As soon as the FR2+ detects that the defibrillator pads are connected properly, it automatically begins analyzing the patient’s heart rhythm. Do not touch the patient during rhythm analysis. The M3860A FR2+ can display the patient’s ECG on the screen. When the ECG display is enabled, the patient’s heart rate is also displayed during background monitoring and when...
The screen also shows how much time has gone by since the FR2+ was turned on, * and how many shocks have been delivered. The M3860A FR2+ also displays the ECG, if enabled, during this period. M3860A/M3861A HEARTSTART FR2+ You must press the button for a shock to be delivered.
ECG Display for Ongoing Observation At the discretion of emergency care personnel, the M3860A FR2+ with ECG display enabled can also be used with the M3873A/M3874A FR2+ ECG assessment module. The FR2+ used with the FR2+ ECG assessment module provides a non-diagnostic ECG display of the patient’s heart rhythm for attended patient monitoring.
Page 26
C A U T I O N damage the pads. Discard the defibrillator pads if they become damaged. M3860A/M3861A HEARTSTART FR2+ During defibrillation, air pockets between the skin and Do not let the defibrillator pads touch each other or other ECG...
Maintaining, Testing, and Troubleshooting Your HeartStart FR2+ Overview This chapter provides information on HeartStart FR2+ Defibrillator maintenance, detailed descriptions of the selftests, and a guide to troubleshooting. Maintenance Maintenance of the FR2+ is very simple, but it is a very important factor in its dependability.
Check the outside of the FR2+ and the connector socket for cracks or other signs of damage. If you see signs of damage: Contact Philips Medical Systems for technical support. Check the operation of the FR2+ by removing and reinstalling the battery and running the battery insertion selftest.
Check the connector socket to make sure that defibrillator pads are disconnected from the FR2+ when it is not in use. Check to make sure the data card tray is installed, even if a data card is not being used. Cleaning the HeartStart FR2+ The outside of the FR2+, including the defibrillator pads connector socket, can be cleaned with a soft cloth dampened in one of several appropriate...
Page 30
“Install Before” date • Data cards, undamaged, and spare data card tray Status Indicator Shows alternating hourglass/square; selftest passed. Inspected by Signature or initials of operator completing the maintenance inspection Remarks, Problems, Corrective Actions M3860A/M3861A HEARTSTART FR2+ OPERATOR'S CHECKLIST...
However, in the event that the FR2+ has been dropped or mishandled, it is recommended that the battery be removed and reinstalled to initiate a selftest. If the FR2+ has visible signs of damage, contact Philips Medical Systems for technical support.
Page 32
FR2+ prior to installing the battery. If the automatic part of the selftest fails: M3860A/M3861A HEARTSTART FR2+ The data card is typically capable of storing a number of incidents. It is recommended that the M3848A FR2+ rechargeable battery not...
Page 33
FR2+ will be ready for use. If something 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 Philips Medical Systems for technical support.
Page 34
Screen prompt: > Press the Shock button and listen for a beep to confirm the press. > Look at the screen to be sure the button press has been verified. M3860A/M3861A HEARTSTART FR2+ test description CHECK SPEAKER SOUND CHECK SHOCK BUTTON LIGHT AND PADS CONNECTOR LIGHT PRESS THE OPTION BUTTONS confirm each press.
If proper operation of all features has not been verified in the interactive selftest, you may want to rerun the battery insertion selftest. If a feature of operation cannot be verified, contact Philips Medical Systems for technical support. Periodic selftests In addition to the battery insertion selftest, the FR2+ automatically performs periodic selftests (PSTs).
The battery history information is read from the internal memory of the battery. It includes: M3860A/M3861A HEARTSTART FR2+ — how many tests have been run. Four figures are shown: daily TESTS (upper left), weekly (upper right), and monthly (lower left) periodic selftests, and battery insertion selftests (lower right).
N O T E 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.
POOR PADS CONTACT • The defibrillator pads, cable, or Voice and screen prompts: REPLACE PADS • The FR2+ has detected a possible M3860A/M3861A HEARTSTART FR2+ possible cause low. depleted. The FR2+ will turn off if a new battery is not installed.
Page 39
symptom • The patient is being moved or jostled. Voice prompts: • Radio or electrical sources are ANALYZING INTERRUPTED interfering with ECG analysis. • The environment is dry and movement CANNOT ANALYZE around the patient is causing static electricity to interfere with ECG STOP ALL MOTION analysis.
CHIRPING Screen prompt (displayed for 10 seconds at the end of a BIT, before FR2+ turns off): NOT READY FOR USE SELFTEST FAILED M3860A/M3861A HEARTSTART FR2+ possible cause low. recommended temperature range. the self-test. its daily self-tests. recommended action • Replace battery with a new...
Page 41
symptom • The battery is missing or completely Status Indicator: depleted. SOLID RED X • The training & administration pack is Audio signal: being used in the administration NONE function (the solid red X is normal in this case) or has been left in the FR2+ by mistake.
The user should be qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response. At the discretion of emergency care personnel, the M3860A FR2+ N O T E with ECG display enabled can also be used with the FR2+ ECG assessment module to display the rhythm of a responsive or breathing patient, regardless of age.
GROUPS: SAFETY CONCERNS ABOUT THE HEARTSTART FR2+ IN GENERAL USE, DEFIBRILLATION, MONITORING, AND MAINTENANCE ACTIVITIES. The dangers, warnings, and cautions listed in the following tables apply to both the model M3860A and the model M3861A HeartStart FR2+, unless otherwise noted. General dangers, warnings, and cautions safety level...
Page 45
Poor electrode pad-to-patient contact may result in a related defibrillator prompt or other indication. Check all electrical and patient connections. CAUTION The HeartStart FR2+ is designed to be used only with Philips-approved accessories. The HeartStart FR2+ may perform improperly if non-approved accessories are used. CAUTION Follow all instructions supplied with the HeartStart defibrillator pads.
CAUTION Use only Philips-approved data cards. The HeartStart FR2+ may perform improperly if non-approved accessories are used. safety level WARNING Radio-frequency (RF) interference from devices such as cellular phones and two-way radios can cause improper HeartStart FR2+ operation. The HeartStart FR2+ should be used at least 6 feet (2 meters) away from RF devices, as stated in accordance with EN 61000-4-3:1996.
ECG recordings CAUTION The LCD screen on the HeartStart 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.
Page 48
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. M3860A/M3861A HEARTSTART FR2+ possible fire or shock hazard...
1, 2, 3, 4, 5, 6, 7, 8 record voice YES, NO ECG display ON, OFF (M3860A only) autosend PST ON, OFF default description Sets volume of the FR2+’s speaker. 1 is lowest; 8 highest. The speaker is used for voice prompts and the charge-done tone.
(minutes) CPR timer 0.5, 1.0, 1.5, (minutes) 2.0, 2.5, 3.0 M3860A/M3861A HEARTSTART FR2+ default Sets the number of shocks that must be delivered to activate an automatic CPR pause. The length of the CPR pause after completion of a Shock Series is defined by the CPR Timer setting.
Page 51
parameter settings NSA action MONITOR (minutes) 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 CPR prompt LONG SHORT monitor prompt 1.0, 1.5, 2.0, interval 2.5, 3.0, ∞ (minutes) (infinite) default description Sets how the FR2+ behaves following a NO SHOCK MONITOR ADVISED (NSA) decision: MONITOR —...
— disables advanced mode features. — enables user-initiated rhythm analysis and ANALYZE disarm, and (M3860A only) automatically turns on ECG display when advance mode is entered. (M3860A only) — in addition to enabling the CHARGE analyze feature, enables user-initiated charging and disarming.
parameter settings resume key advanced use 0.5, 1.0, 1.5, prompt 2.0, 2.5, 3.0 interval (minutes) Using Setup Features N O T E follows: • Press the item to another on the menu. • Press the scroll through the settings for that item. The FR2+ comes with a factory default setup designed to meet the needs of most users.
3. The last screen allows you to select Revising setup There are several ways to change the setup of your HeartStart FR2+. All of them require use of products or accessories available separately from Philips Medical Systems. M3860A/M3861A HEARTSTART FR2+...
Use the infrared communications feature of the FR2+ to receive the revised setup from another FR2+. (Instructions are provided later in this chapter.) Use the infrared communications feature of the FR2+ to receive the revised setup from a computer running HeartStart Event Review software.
1. Remove and reinstall the battery of both FR2+ devices to bring up the 2. Select 3. Select 4. Locate the infrared communications port on each FR2+ and line them up M3860A/M3861A HEARTSTART FR2+ “receiving” FR2+ displays a SETUP COMPLETE HeartStart FR2+ immediately uses the new setup.
uninterrupted view of the “eye” in the other. (See the diagram on the back of the first page of this manual.) The two devices should be no more than 1 meter apart. 5. Select from the SEND TIME CLOCK FR2+. 6.
Using the manual analyze feature The Manual Analyze feature is available in both the M3860A and the M3861A models, when enabled in setup. To enter the advanced mode during use of an FR2+ that has this feature enabled, press both Option buttons simultaneously.
On/Off button. Then turn the FR2+ on by pressing the On/Off button again. Using the manual charge feature (M3860A only) The manual charge feature is available only in the M3860A, when enabled in setup. To enter the advanced mode during use of an FR2+ that has this feature enabled, press both Option buttons simultaneously.
Page 60
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. M3860A/M3861A HEARTSTART FR2+ MANUAL CHARGE , and the label for the arrowhead pointing to the upper Option...
I M P O R T A N T N O T E must be installed before you turn on the FR2+. The FR2+ is designed to be used only with Philips-approved C A U T I O N accessories. The FR2+ may perform improperly if non-approved accessories are used.
Page 62
To ensure that no incident data are lost, turn the FR2+ off (return it to standby mode) before replacing the battery. M3860A/M3861A HEARTSTART FR2+ over the matching yellow area on the data card. The label on the card should face up.
To replace a data card: You must turn the FR2+ off (return it to standby mode) before I M P O R T A N T you remove the data card, to ensure that no incident data are lost. 1. Press the On/Off button to turn off the FR2+. Never replace the data card unless the FR2+ is turned off.
2. Make sure the data card is installed. Unplug the pads connector. 3. Remove and reinstall the battery. 4. Select 5. To review the events that occurred during the incident, select M3860A/M3861A HEARTSTART FR2+ from the menu. A new screen comes up. This REVIEW INCIDENT screen displays: —...
Page 65
Additional information may be displayed if your FR2+ is using a revised setup allowing advanced mode operation. 6. To review the first six seconds of the recorded presenting incident, select . A new screen comes up. This screen REVIEW ECG displays a three-second segment of the presenting incident.
2 pairs of gloves, a pair of paramedics scissors, and an absorbent wipe) M3873A/M3874A FR2+ ECG assessment module, 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 &...
Technical Specifications The specifications for the HeartStart FR2+ provided in this chapter apply to both the M3860A and M3861A, unless otherwise noted. Additional information can be found in the Defibrillator, located online at www.medical.philips.com. HeartStart FR2+ Defibrillator Specifications Physical category Size 2.6"...
Page 70
M3860A/M3861A HEARTSTART FR2+ nominal specifications nominal specifications the final voltage.
Page 72
• the defibrillator pads are removed from the patient, OR • the pads connector is disconnected from the FR2+. in advanced mode CHARGE (M3860A only) • the manual disarm button is pressed, OR • a shock is not delivered within 30 s after charging, OR •...
Page 73
II) position or from FR2 infant/child reduced-energy defibrillator pads in anterior-posterior position. (Displayed on M3860A only.) ECG information can also be displayed in the M3860A using the FR2+ ECG assessment module. NO TE: The ECG display provided by the FR2+ Defibrillator is not is not intended to provide diagnostic or ST segment interpretation.
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 32° to 109° F (0° to 43° C). M3860A/M3861A HEARTSTART FR2+ nominal specifications warning, as appropriate. REPLACE BATTERY...
Page 75
(Optional) M3848A FR2+ rechargeable battery category Battery Type 11.3 VDC, 6.5 Ah, lithium ion. Rechargeable cell using the M3849A charger. Capacity When freshly charged and used at 77° F (25° C) , provides a minimum of 80 (typically 100) shocks, or 3.5 hours (typically 5 hours) of ECG display time only, before recharging is indicated.
Page 76
Environmental 32° to 113° F (0° to 45° C). Requirements 35% to 85% relative humidity (non-condensing). Conformance Testing International: EN60335-1:1994 Class I North America: UL 1310 Class 2 M3860A/M3861A HEARTSTART FR2+ nominal specifications nominal specifications nominal specifications nominal specifications...
Page 77
Application For use with the FR2+ M3860A with ECG display enabled and running version 1.5 software or higher (denoted by FR2+ on the front panel or rear label). 100 inches (182 cm); ≤ 1 lb. (2.2 kg). Length and Weight Operating Temperature and 32°...
Instructions for Use symbol Meets the requirements of the European medical device directives. Printed on recycled paper. HeartStart FR2+ M3860A and M3861A Defibrillator Symbols and Controls Control panel and back label symbol On/Off button. Turns the HeartStart FR2+ on or off;...
Page 80
HeartStart FR2+ display screen M3860A/M3861A HEARTSTART FR2+ symbol High voltage. Refer to operating instructions. Meets the requirements of the European medical device directives. This product has passed relevant safety tests by CSA, a nationally recognized test lab. IP54 With data card tray and battery installed, meets IEC 529 class IP54.
Status indicator symbol Flashing black hourglass. Ready for use. Solid red X. Not ready for use. (See Chapter 4, “Maintaining, Testing, and Troubleshooting Your HeartStart FR2+. ” ) Flashing red X. Troubleshooting required. (See Chapter 4, “Maintaining, Testing, and Troubleshooting Your HeartStart FR2+.
Page 82
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Pad placement for adults. (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.
Page 83
symbol Box contents = 2 pouches. (DP2) Box contents = 6 pouches. (DP6) This side up. Fragile. Protect from moisture. Printed on recycled paper. M3863A standard battery and M3848A FR2+ rechargeable battery symbol Do not crush. Do not expose to high heat or open flames. Do not incinerate.
Page 84
M3849A charger for the M3848A FR2+ rechargeable battery M3860A/M3861A HEARTSTART FR2+ symbol 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.
Page 85
symbol High voltage. Protect from moisture. On/Off indicator. 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.
Page 86
M3873A/M3874A FR2+ ECG assessment module M3864A training & administration pack M3860A/M3861A HEARTSTART FR2+ symbol 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.
Page 87
C -9 symbol description Do not crush. Do not expose to high heat or open flames. Do not incinerate. Do not mutilate 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.
Page 88
C-10 M3855A charger for the M3864A training & administration pack) M3860A/M3861A HEARTSTART FR2+ symbol Printed on recycled paper. symbol Refer to operating instructions. High voltage. Protect from moisture. On/Off indicator. Charger status indicator. Meets the requirements of the EMC directives.
FR2+ and its use..A programmable treatment mode that permits an authorized user to control advanced mode when the FR2+ starts rhythm analysis and (model M3860A only) when to begin defibrillator charging for shock delivery..Automated external defibrillator.
Page 90
(VTs). See “ ... A dedicated data management software system (formerly sold as HeartStart Event Review 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.
Page 91
non-shockable A heart rhythm that the HeartStart FR2+ determines is not appropriate for rhythm shock delivery..No Shock Advised decision, made by the HeartStart FR2+ based on analysis of the patient’s heart rhythm..External or implanted cardiac pulse generator that stimulates the heart pacemaker electronically.
Page 92
... This is a special window in the upper right-hand corner of the front panel of status indicator the HeartStart FR2+ that lets you know the status of the device. sudden cardiac The sudden cessation of the heart’s pumping rhythm. arrest M3860A/M3861A HEARTSTART FR2+ SMART analysis. ” SMART biphasic waveform. ”...
Page 93
training & An optional accessory for the FR2+ that enables training and administrative administration pack functions. The integral battery should be charged only using the M3855A charger. SMART ... See “ waveform ... A feature of the HeartStart FR2+ that allows it to record setup information on write (data) a data card.
Page 95
Index accessories additional, recommended A-2 adult defibrillator pads A-1 available to order A-1 charger for M3848A rechargeable battery A-1 charger for training & administration pack A-1 data card A-1 data card tray A-1 fabric carrying case A-1 fast response kit A-1 FR2+ ECG assessment module infant/child defibrillator pads A-1 rechargeable battery A-1...
Page 102
P O W E R S A V E Philips Medical Systems is part of Royal Philips Electronics L I F E Philips Medical Systems Philips Medical Systems 2301 Fifth Avenue, Suite 200 Seattle, WA 98121, USA (800) 263-3342 Canada...
Need help?
Do you have a question about the M3860A and is the answer not in the manual?
Questions and answers