P O W E R TO SAV E A L I F E HEARTSTART FR2+ DEFIBRILLATOR INSTRUCTIONS FOR USE M3860A, M3861A Edition 10
A Battery. Standard long-life or rechargeable battery used to power the FR2+. (Check local regulations for disposal and recycling requirements.) G Infrared (IR) communications port. A special lens, or “eye,” used to transfer data directly to or from another device. M Speaker. Amplifies voice prompts during use of the FR2+. B On/Off button. Turns on the FR2+ and starts voice and screen prompts. Second press turns off the FR2+. H Data card port. Receptacle for data card tray. N Pads placement diagram.
Philips Medical Systems HEARTSTART FR2+ DEFIBRILLATOR QUICK R E FER E NCE CAR D
Philips Medical Systems Intentionally left blank.
HEARTSTART FR2+ M3860A, M3861A Defibrillator I NSTR UCTIO NS FOR U SE Philips Medical Systems Edition 10
Instructions for Use Authorized EU Representative Equipment specifications are subject to alteration without notice. All changes will be in compliance with regulations governing manufacture of medical equipment. Philips Medizinsysteme Boeblingen GmbH Hewlett-Packard Strasse 2 71034 Boeblingen, Germany (+49) 7031-14-5151 Printed in the U.S.A. CAUTION Publication date: August 2003 Publication number: M3860-91900 Part number: 011120-0010 © 2003 Philips Electronics North America Corp.
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? ................................................ 1-1 1-2 1-2 1-3 2 Preparing Your HeartStart FR2+ for Use Overview .............................................
2 5 Clinical and Safety Considerations Clinical Considerations .............................................................................. Indications ............................................................................................. Contraindications ................................................................................ Safety Considerations ................................................................................ General dangers, warnings, and cautions .....................
3 Appendices A Accessories for the HeartStart FR2+ HeartStart Accessories ............................................................................. Suggested Additional Items ..................................................................... A-1 A-2 B Technical Specifications HeartStart FR2+ Defibrillator Specifications ........................................ Accessories Specifications ......................................................................
Philips Medical Systems Notes M3860A/M3861A HEARTSTART FR2+
1 1 Introduction to the HeartStart FR2+ What is the HeartStart FR2+? The HeartStart FR2+ Defibrillator (“FR2+”) is an automated external defibrillator. It is compact, lightweight, portable, and battery powered. It is designed for simple and reliable operation by a trained responder. N O T E : The HeartStart FR2+ is an enhanced version of the defibrillator previously sold as the Heartstream FR2. The FR2+ has all the features of the FR2.
1-2 When Is the HeartStart FR2+ Used? The HeartStart FR2+ Defibrillator is used with disposable defibrillator pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): lack of responsiveness and lack of breathing. Defibrillation should not be performed on anyone who is responsive or is breathing. Infant/child reduced-energy defibrillator pads are available for use with the FR2+ on children under the age of 8 or weighing less than 55 pounds (25 kg).
1-3 How Is the HeartStart FR2+ Supplied? Philips Medical Systems The HeartStart FR2+ Defibrillator is supplied with a standard long-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.
Philips Medical Systems Notes M3860A/M3861A HEARTSTART FR2+
2 Preparing Your HeartStart FR2+ for Use 2 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. The instructions presented here briefly describe the normal sequence of preparation.
2-2 When the battery is installed, the FR2+ automatically turns on. The Status Indicator displays a flashing black hourglass. The Shock button light and the indicator light for the defibrillator pads connector socket turn on briefly. The display screen brings up the main menu. From this menu, you can start the FR2+ battery insertion selftest, review information from the last time the FR2+ was used, or go to the next screen for other options.
2-3 N O T E : If you make no selection for 10 seconds, the selftest will 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. You can press the On/Off button at any time to turn off the FR2+ and return it to standby (ready for use) mode. To use the FR2+, press the On/Off button again.
2-4 To manually set the clock: 1. Use the lower Option button to move the highlight bar to the part of the clock setting you want to change. 2. Press the upper Option button repeatedly to scroll through the settings until you reach the one you want. If you go past it, keep scrolling until it comes up again. 3. Use the lower Option button to select the next part you want to change, and repeat the process, until all parts of the date and time have been set. 4.
2-5 3. Press the upper Option button to activate the test. 4. OR make no selection for 10 seconds, and the selftest will start automatically if the FR2+ has been turned off for at least 5 minutes. N O T E : If you connect defibrillator pads (that are applied to the patient) to 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.
Philips Medical Systems Notes M3860A/M3861A HEARTSTART FR2+
3 Using Your HeartStart FR2+ Overview This chapter describes how to use the HeartStart FR2+ Defibrillator in an emergency incident. Some general things to remember are: Try to relax and stay calm. The FR2+ automatically provides appropriate voice and display prompts to guide you. The defibrillator pads must have good contact with the patient’s skin. The pads have a layer of sticky, conductive gel beneath the protective backing. To work effectively, the gel must not be dried out.
3-2 Step 1: Preparation • OFF ON Press the On/Off button to turn on the HeartStart FR2+ Defibrillator. Follow the instructions provided by the FR2+ voice and screen prompts in the order indicated. Remove clothing from the patient's upper body. Wipe moisture from the patient's skin and clip or shave excessive chest hair, if necessary. If the patient appears to be under eight years of age or 55 lbs (25 Kg), use M3870A FR2 infant/child reduced-energy defibrillator pads, if available.
3-3 Step 2: ECG Analysis and Monitoring Follow the instructions provided by the HeartStart FR2+ Defibrillator’s voice and screen prompts in the order indicated. 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.
3-4 Step 3: Shock Delivery Press the Shock button to deliver the shock. I M P O R T A N T : You must press the button for a shock to be delivered. The HeartStart FR2+ Defibrillator will not automatically deliver a shock. There are four ways you can tell that the FR2+ is ready to deliver a shock: you hear a voice prompt telling you to deliver a shock, you see the Shock button flashing, you hear a steady tone, and/or you see a screen prompt telling you to press the orange (Shock) button.
3-5 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. The system is intended for use on a conscious or breathing patient, regardless of age.
3-6 cleaning the FR2+ Defibrillator. (See Chapter 4, “Maintaining, Testing, and Troubleshooting Your HeartStart FR2+.”) W A R N I N G : During defibrillation, air pockets between the skin and defibrillator pads can cause patient skin burns. To help prevent air pockets, make sure defibrillator pads completely adhere to the skin. Do not use dried-out defibrillator pads.
4 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. The FR2+ performs many maintenance activities itself.
4-2 daily monthly maintenance 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 selftest. If the selftest passes, the FR2+ is ready to use.
4-3 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 cleaning agents (see list below).
4-4 OPERATOR'S CHECKLIST HeartStart FR2+ Model No.: ______________________Serial No.
4-5 Testing The HeartStart FR2+ Defibrillator has several ways of testing itself and alerting you if it finds a problem. In addition to the selftest performed each time a battery is installed, the FR2+ also automatically performs periodic selftests daily. N O T E : The FR2+ selftests are designed to check that the FR2+ is ready for use. 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.
4-6 When you install the battery, the screen tells you whether or not a data card is installed. If so, a screen message displays how much recording time is left until the data card is full. (See Chapter 7, “Data Management and Review,” for how to review the incident information from the internal memory of the FR2+ or from a data card, if one is used.) N O T E : The data card is typically capable of storing a number of incidents. However, it is recommended that it be replaced after every use.
4-7 The screen displays a message that the selftest has failed. After a short time, an error code is displayed. Write down the error code and contact Philips Medical Systems for technical support. The Status Indicator shows a flashing or solid red X. Replace the battery with a new battery and repeat the test. If the second selftest fails, contact Philips Medical Systems for technical support.
4-8 The following table describes the parts of the FR2+ tested in the interactive part of the selftest and any action you are asked to take. feature speaker test description Screen prompt: CHECK SPEAKER SOUND (2 beeps) > Listen for the two beeps from the speaker. lights Screen prompt: CHECK SHOCK BUTTON LIGHT AND PADS CONNECTOR LIGHT > Check that the lights come on.
4-9 feature test description Screen prompt: PRESS THE ON/OFF BUTTON on/off button > Press the On/Off button and listen for a beep to confirm press. > Look at the screen to be sure the button press has been verified. The screen then displays a message that the test is complete. When the interactive part of the battery insertion selftest is complete, the FR2+ turns off and goes to standby mode to be ready for use.
4-10 TESTS — how many tests have been run. Four figures are shown: daily (upper left), weekly (upper right), and monthly (lower left) periodic selftests, and battery insertion selftests (lower right). REV — device language, model, and software revision. Battery History Information about use of the battery currently installed in your FR2+ is also available.
4-11 Troubleshooting Guide Status indicator summary status indicator meaning Flashing black hourglass The FR2+ passed the battery insertion self-test or the last periodic self-test and is therefore ready for use. Flashing red X accompanied by a chirping sound. A self-test error has occurred or the battery is low or depleted. Solid red X The battery is completely depleted or a self-test failure occurred. N O T E : Perform CPR (if needed) any time there is a delay before the FR2+ can be used.
4-12 If neither of these actions clears the problem, do not use the FR2+. Attend to the patient, providing CPR if needed, until emergency medical personnel arrive. Troubleshooting during patient use symptom possible cause recommended action STATUS INDICATOR: FLASHING RED X Screen and voice prompts: LOW BATTERY Screen and voice prompts: REPLACE BATTERY NOW • The energy remaining in the battery is low. • The energy in the battery is nearly depleted.
4-13 symptom Voice prompts: ANALYZING INTERRUPTED or CANNOT ANALYZE or STOP ALL MOTION Voice and screen prompts: NO SHOCK DELIVERED Voice prompt: recommended action • The patient is being moved or jostled. • Radio or electrical sources are interfering with ECG analysis. • The environment is dry and movement around the patient is causing static electricity to interfere with ECG analysis. • Stop CPR; do not touch the patient. Minimize patient motion.
4-14 symptom Status Indicator: FLASHING RED X Audio signal: CHIRPING Status Indicator: FLASHING OR SOLID RED X Audio signal: CHIRPING possible cause recommended action • The energy remaining in the battery is low. • The FR2+ has been stored outside the recommended temperature range. • An error has been detected as part of the self-test. • The FR2+ has been unable to perform its daily self-tests.
4-15 symptom Status Indicator: SOLID RED X Audio signal: NONE Status Indicator: SOLID RED X Audio signal: CHIRPING Status Indicator: Philips Medical Systems NONE possible cause recommended action • The battery is missing or completely depleted. • The training & administration pack is being used in the administration function (the solid red X is normal in this case) or has been left in the FR2+ by mistake. • A self-test detected a failure.
Philips Medical Systems Notes M3860A/M3861A HEARTSTART FR2+
5 Clinical and Safety Considerations Clinical Considerations Indications The HeartStart FR2+ is indicated for use on victims of sudden cardiac arrest exhibiting the following signs: Unresponsiveness Absence of normal breathing The HeartStart FR2+ is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response.
5-2 C A U T I O N — conditions, hazards, or unsafe practices that can result in minor personal injury, damage to the HeartStart FR2+, or loss of data stored in the device. THESE SAFETY CONSIDERATIONS ARE DIVIDED INTO FOUR 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.
5-3 Philips Medical Systems safety level possible improper device performance WARNING Prolonged or aggressive CPR to a patient with defibrillator pads attached can damage the pads. Replace the defibrillator pads if they are damaged during use or handling. WARNING Using damaged or expired equipment or accessories may cause the HeartStart FR2+ to perform improperly, and/or injure the patient or the user.
5-4 safety level CAUTION safety level WARNING possible improper device performance Use only Philips-approved data cards. The HeartStart FR2+ may perform improperly if non-approved accessories are used. possible electrical interference with ECG monitoring Radio-frequency (RF) interference from devices such as cellular phones and two-way radios can cause improper HeartStart FR2+ operation.
5-5 safety levels possible burns and ineffective energy WARNING Do not allow the defibrillator pads to touch each other or other ECG electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may also divert the defibrillation current away from the heart. WARNING During defibrillation, air pockets between the skin and defibrillator pads can cause patient skin burns.
5-6 safety level 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.
6 Setup and Advanced Mode Features Setup Overview The “setup” of the HeartStart FR2+ Defibrillator is made up of several programmable aspects, or parameters, of FR2+ operation. Some setup parameters govern specific features that are not related to the patient care protocol, some are used to define the automatic patient care protocol used by the FR2+, and some provide options for manual override of the protocol during use. The FR2+ comes with a factory default setup designed to meet the needs of most users.
6-2 Automatic protocol parameters The HeartStart FR2+ is designed to follow an automatic protocol that guides you through patient treatment with the defibrillator. The default settings for programmable parameters used in the automatic protocol can be altered by your Medical Director if desired. parameter settings default description 1, 2, 3, 4 3 Sets the number of shocks that must be delivered to activate an automatic CPR pause.
6-3 parameter NSA action (minutes) settings default MONITOR, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 MONITOR description Sets how the FR2+ behaves following a NO 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 the Monitor Prompt Interval. TIME SETTING — directs the FR2+ to provide a CPR pause period following an NSA decision (NSA CPR Pause).
6-4 Manual override parameters The HeartStart FR2+ provides several ways of overriding the automatic protocol. The parameters in the following table are used to enable different kinds of manual override. parameter advanced settings default OFF, OFF description ANALYZE, Enables or disables advanced mode entry for ALS or tiered-response systems. CHARGE OFF — disables advanced mode features.
6-5 parameter resume key advanced use prompt interval (minutes) settings default description ON, OFF OFF Enables (ON) or disables (OFF) user-initiated interruption of the CPR pause and return to analyzing. If either the CPR Timer or the NSA Action setting is programmed to 1.5 minutes or longer, the Resume Key setting is automatically enabled (ON). If enabled, the Resume Key is accessed by pressing the lower Option button indicated by an arrow on the FR2+ display, as shown in the sample screen: 0.
6-6 2. Within 10 seconds of installing the battery, press the lower Option button to move the highlight bar to NEXT. 3. Press the upper Option button to select NEXT. 4. Press the lower Option button to move the highlight bar to SETUP. 5. Press the upper Option button to bring up the SETUP menu. The SETUP menu allows you to receive setup directly from another HeartStart FR2+ or a computer running HeartStart Event Review software, read setup from a data card, or review current setup.
6-7 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. (Instructions are provided with the HeartStart Event Review software.
6-8 “receiving” FR2+ displays a SETUP COMPLETE message. Your HeartStart FR2+ immediately uses the new setup. Receiving setup from a computer running HeartStart Event Review software is discussed in the directions for use provided with HeartStart Event Review software. Reading setup This method copies setup data from a data card to your HeartStart FR2+. To read the setup, follow these steps: 1. Insert the data card in the data card tray and install the loaded tray into the data card slot in the FR2+. 2.
6-9 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 SEND TIME from the CLOCK screen on the “sending” HeartStart FR2+. 6. Select RECEIVE TIME from the CLOCK screen of the “receiving” FR2+. 7. A new screen comes up. Until the two FR2+ devices are properly positioned, the screen on the receiving FR2+ displays READY TO RECEIVE and prompts you to check the sending FR2+.
6-10 model used. For the M3860A, the user can select ANALYZE, CHARGE, or OFF. For the M3861A the user can select only ANALYZE or OFF. (Detailed directions for use are supplied with the training & administration pack.) C A U T I O N : Alteration of the factory default setup of the FR2+ can affect its performance and should be performed under the authorization of your Medical Director.
6-11 In the M3861A HeartStart FR2+, the patient’s ECG is not displayed; in the M3860A, the display includes the patient’s ECG and heart rate. Press the lower Option button (ANALYZE) to initiate rhythm analysis by the FR2+. If a shock is advised, the FR2+ automatically charges, and prompts you to press the Shock button. After shock delivery, the HeartStart FR2+ returns to the advanced mode display and monitors the patient’s heart rhythm.
6-12 The highlighted top line is labeled MANUAL CHARGE, with an arrowhead pointing to the upper Option button. If the ECG display shows that, in your expert clinical judgment, the patient has a shockable rhythm, press the upper Option button (MANUAL CHARGE). The HeartStart FR2+ will immediately charge for shock delivery. As soon as charging begins, the screen message changes to CHARGING, STAND CLEAR, and the label for the arrowhead pointing to the upper Option button changes to MANUAL DISARM.
7 Data Management and Review Overview The HeartStart FR2+ is designed to make it easy to manage incident data. Some information is automatically stored in the internal memory of the HeartStart FR2+. More detailed data can be stored on a data card if desired. The incident information stored in the HeartStart FR2+’s internal memory, or a summary of the information recorded on the data card, can then be displayed on the HeartStart FR2+ screen for review.
7-2 To install a data card: 1. Make sure the data card is clean and dry. 2. Load the data card into its plastic tray, with the tray’s “tongue” fitting over the matching yellow area on the data card. The label on the card should face up. The label has an arrow indicating which side to insert into the data card port. 3. Make sure the FR2+ is off (in standby mode), or that the battery has been removed. 4.
7-3 To replace a data card: I M P O R T A N T : You must turn the FR2+ off (return it to standby mode) before 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. Remove the loaded data card tray by grasping its handle and pulling it out of the port. 3. Remove the data card from the tray. 4. Give the data card to the appropriate person in your organization. 5.
7-4 Reviewing data from a data card If a data card is installed when the HeartStart FR2+ is turned on for use during an incident, the HeartStart FR2+ automatically records detailed information on the data card. To review this information on the HeartStart FR2+ screen: 1. Make sure the training & administration pack is not installed. 2. Make sure the data card is installed. Unplug the pads connector. 3. Remove and reinstall the battery. 4. Select REVIEW INCIDENT from the menu. A new screen comes up.
7-5 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 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. Philips Medical Systems Data cards can be reused if desired.
Philips Medical Systems Notes M3860A/M3861A HEARTSTART FR2+
A Accessories for the HeartStart FR2+ HeartStart Accessories Accessories for the HeartStart FR2+ available separately from Philips Medical Systems include the following: Philips Medical Systems * † ‡ Spare M3863A FR2 standard battery (recommended) DP2/DP6 adult defibrillator pads M3870A FR2 infant/child reduced-energy defibrillator pads Spare M3853A data card tray M3854A data card and tray M3868A fabric carrying case M3869A vinyl carrying case M3857A wall mount bra
A-2 Suggested Additional Items It may be useful to keep some additional items with your HeartStart FR2+ for use if 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.
B B 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 Technical Reference Manual for the FR2 Defibrillator, located online at www.medical.philips.com. HeartStart FR2+ Defibrillator Specifications Physical category nominal specifications Size 2.6" high x 8.6" wide x 8.6" deep (6.6 cm x 21.8 cm x 21.8 cm). Weight Approximately 4.7 lbs (2.
B-2 category nominal specifications EMI (Immunity) Meets EN 60601-1-2 limits (1993), method EN 61000-4-3:1998 Level 2 (3 V/m and 10 V/m at 26 MHz to 1 GHz). Aircraft: Method Meets RTCA/DO-160D:1997 Section 21 (Category M - Charging). Defibrillator category Waveform Parameters nominal specifications Biphasic truncated exponential. Waveform parameters are automatically adjusted as a function of patient defibrillation impedance.
B-3 category Energy nominal specifications Using adult defibrillator pads: 150 J nominal into a 50 ohm load. Using infant/child reduced-energy defibrillator pads: 50 J nominal into a 50 ohm load. Sample pediatric energy doses: age energy dose newborn 14 J/kg 1 year 5 J/kg 2 − 3 years 4 J/kg 4 − 5 years 3 J/kg 6 − 8 years 2 J/kg Doses indicated are based on CDC growth charts for the 50th percentile weights for boys.
B-4 category Disarm (advanced mode) nominal specifications Once charged, the HeartStart FR2+ will disarm if: in advanced mode ANALYZE • the manual disarm button is pressed, OR • a patient’s heart rhythm changes to non-shockable rhythm, OR • a shock is not delivered within 30 seconds after the FR2+ is armed, OR • the On/Off button is pressed to turn off the FR2+, OR • the defibrillator pads are removed from the patient, OR • the pads connector is disconnected from the FR2+.
B-5 category Pacemaker Detection nominal specifications On detection of a pacemaker (in advanced mode or with M3873A/M3874A FR2+ ECG assessment module), provides screen display of PACEMAKER DETECTED alert. M3860A includes pacemaker artifact in ECG display. In both models, pacemaker artifact is removed from the signal for rhythm analysis.
B-6 category nominal specifications Controls On/Off button Shock button Option buttons LED Indicators Connector socket LED, flashes to indicate socket location. LED is covered when defibrillator pad connector is properly inserted. Shock button LED flashes when defibrillator is armed. Audio Speaker Provides voice prompts (volume is adjustable via Setup screen). Beeper Chirps when a selftest has failed. Provides various warning beeps during normal use.
B-7 (Optional) M3848A FR2+ rechargeable battery category nominal specifications 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. Status Indicators Good battery: bar graph on display screen indicating remaining power level.
B-8 category Defibrillator Pad Requirements nominal specifications Use only DP2/DP6, M3870A, M3713A, and M3716A defibrillator pads with the HeartStart FR2+. Place the pads on the patient as illustrated on each pad. (Optional) M3854A data card category Capacity nominal specifications 8 hours of event and ECG data, or 60 minutes with voice recording. (Optional) M3864A training & administration pack category nominal specifications Battery Type 12 V, 1.1 Ah, nickel metal hydride.
B-9 (Optional) M3873A/M3874A FR2+ ECG assessment module category nominal specifications 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). Length and Weight 100 inches (182 cm); ≤ 1 lb. (2.2 kg). Operating Temperature and Humidity 32° to 122° F (0° to 50° C); 0% to 95% relative humidity (non-condensing). Storage Temperature and Humidity 32° to 109° F (0° to 43° C).
Philips Medical Systems Notes M3860A/M3861A HEARTSTART FR2+
C Glossary of Symbols and Controls Instructions for Use symbol C description 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 description • OFF ON On/Off button. Turns the HeartStart FR2+ on or off; disarms HeartStart FR2+, stops automatic self-test.
C-2 symbol description 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. HeartStart FR2+ display screen symbol XX XX:XX TEMPERATURE SETUP REV: XXX X.X XXXX M3860A/M3861A HEARTSTART FR2+ Heart rate. Number of shocks delivered. Time.
C -3 Status indicator symbol description 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+.”) Accessories Symbols M3870A and DP2/DP6 defibrillator pads symbol description These pads are disposable and are for single patient use only.
C-4 symbol description Lot number. Use the pads before the date shown. Date format is YYYY-MM. 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. (DP2/DP6) Meets the requirements of the EMC directives.
C -5 symbol 2 description Box contents = 2 pouches. (DP2) C 6 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 description Philips Medical Systems 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.
C-6 symbol description 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. Printed on recycled paper. M3849A charger for the M3848A FR2+ rechargeable battery symbol description Refer to operating instructions.
C -7 symbol description High voltage. C 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. N11695 V00341 Printed on recycled paper. Philips Medical Systems Electrical input.
C-8 M3873A/M3874A FR2+ ECG assessment module 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. M3864A training & administration pack symbol description Refer to operating instructions. M3860A/M3861A HEARTSTART FR2+ Philips Medical Systems Printed on recycled paper.
C -9 symbol description Do not crush. C 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. Kit contains Training & Administration Pack, Instructions for Use, and set of training pads. Philips Medical Systems Ship and store the product within the temperature ranges shown. This side up. Fragile.
C-10 symbol description Printed on recycled paper. M3855A charger for the M3864A training & administration pack) symbol description Refer to operating instructions. High voltage. Protect from moisture. On/Off indicator. Charger status indicator. Electrical input. Electrical output Printed on recycled paper. M3860A/M3861A HEARTSTART FR2+ Philips Medical Systems Meets the requirements of the EMC directives.
D Glossary of Terms The terms listed in this Glossary are defined in the context of the HeartStart FR2+ and its use. advanced mode ..................... A programmable treatment mode that permits an authorized user to control when the FR2+ starts rhythm analysis and (model M3860A only) when to begin defibrillator charging for shock delivery. AED .......................................... Automated external defibrillator. AED mode ...............................
D-2 defibrillation shock. Use only DP2/DP6, M3870A, M3713A, and M3716A defibrillator pads with the HeartStart FR2+. ECG .......................................... Electrocardiogram, a display or printout of the electrical rhythm of the heart as detected through defibrillator pads. event ........................................ An action recognized or performed by the HeartStart FR2+ as a step in the sequence of using the device in an incident.
D -3 non-shockable rhythm ................................ A heart rhythm that the HeartStart FR2+ determines is not appropriate for shock delivery. NSA .......................................... No Shock Advised decision, made by the HeartStart FR2+ based on analysis of the patient’s heart rhythm. pacemaker .............................. External or implanted cardiac pulse generator that stimulates the heart electronically. pads ......................................... See “defibrillator pads.
D-4 rhythm analysis ...................... See “SMART analysis.” send (data) ............................. A feature of the HeartStart FR2+ that allows use of its infrared (IR) communications port to send data directly to another FR2+ or a computer running HeartStart Event Review Web software. sensitivity ................................ A measure of the ability of the HeartStart FR2+ to reliably detect and identify shockable heart rhythms. setup ........................................
D -5 training & administration pack .......... 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.
Philips Medical Systems Notes M3860A/M3861A HEARTSTART FR2+
Philips Medical Systems Index A asystole detection B-4 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 A-1 infant/child defibrillator pads A-1 rechargeable battery A-1 standard battery A-1 training & administration pack A-1 vinyl carrying case A-1 wall mount bracket
I-2 continued use 4-5, 7-2, D-1 contrast, adjusting 4-8 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 controls and symbols C-1 disarming the FR2+ in advanced mode B-4 in AED mode B-3 manual 6-12, B-4 CPR prompt definition 6-3 programmable settings 6-3 display screen adjusting contrast 4-8 specifications B-5 CPR timer definition 6-2, D-1 programmable settings 6-2 DP2/DP6 adult defibrillator pads A-1 controls an
I-3 glossary of terms D-1 of symbols and controls C-1 infrared communications description D-2 receiving setup 6-6 H installing the battery 2-1 heart rhythms shockable B-4 L HeartStart M3870A FR2 infant/child reduced-energy defibrillator pads A-1 LCD display see display screen hourglass Status Indicator C-2 M how to install the battery 2-1 M3848A rechargeable battery A-1, B-7 how to remove the data card 7-3 how to review battery history 4-10 M3849A charger for M3848A rechargeable battery A-1, B
I-4 manual mode see advanced mode monitoring, description D-2 N pediatric defibrillation choosing defibrillator pads 3-2 periodic selftests definition D-3 description 4-9 frequency 4-1 Status Indicator alerts 4-9 non-shockable rhythms D-3 presenting ECG definition D-3 description 7-5 NSA action definition 6-3 programmable settings 6-3 prompt interval monitor settings 6-5 NSA, definition D-3 O On/Off button, description of uses C-1 operating temperature B-1 Option buttons description of uses C-1 to
I-5 S safety considerations 5-1 selftests battery insertion 2-4 daily 4-1 monthly 4-1 periodic 2-5, 4-1 sensitivity, definition D-4 setup definition D-4 reading setup 6-8 receiving setup 6-6 shock see SMART biphasic waveform Shock button, description of use C-1 Philips Medical Systems shock series definition 6-2, D-4 programmable settings 6-2 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 scr
I-6 T W temperature operating B-1 standby B-1 warnings, cautions, and dangers 5-2 tiered-response features 6-9 training & administration pack charger A-1 description D-5 troubleshooting 4-11 waveform see SMART biphasic waveform X X Status Indicator flashing or solid 4-11 solid 4-11 U Philips Medical Systems user, qualifications and training 1-2 M3860A/M3861A HEARTSTART FR2+
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P O W E R TO S AV E A L I F E Philips Medical Systems is part Philips Medical Systems of Royal Philips Electronics USA Philips Medical Systems 2301 Fifth Avenue, Suite 200 Seattle, WA 98121, USA (800) 263-3342 Canada Philips Medical Systems 281 Hillmount 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 Me
