HeartStart OnSite Defibrillator OWNER’S MANUAL Guide to Set Up, Operation, Maintenance, and Accessories M5066A Edition 8
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front view AA back view top top BB KK LL C D I F E G H PHILIPS MEDICAL SYSTEMS The HeartStart OnSite Defibrillator M5066A A Pads Cartridge Handle. Pull the handle to turn on the HeartStart and remove the cartridge’s hard cover. B Ready Light. This green light tells you the readiness of the HeartStart. Blinking: Solid: Off: C standby mode (ready for use) in use needs attention (HeartStart “chirps” and i-button flashes) On/Off Button. Press this green button to turn on the HeartStart.
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HeartStart OnSite Defibrillator P H I L I P S M E D I C A L S Y S TE M S QUICK REFERENCE
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HeartStart OnSite M5066A Automated External Defibrillator OWNER’S MANUAL Edition 8 IMPORTANT NOTE: P H I L I P S M E D I C A L S Y S TE M S It is important to understand that survival rates for sudden cardiac arrest are directly related to how soon victims receive treatment. For every minute of delay, the chance of survival declines by 7% to 10%. Treatment cannot assure survival. In some victims, the underlying problem causing the cardiac arrest is simply not survivable despite any available care.
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About this edition Authorized EU representative The information in this guide applies to the model M5066A HeartStart OnSite Defibrillator. Its technical contents apply to all models in the HeartStart HS1 family of defibrillators, including the HeartStart, the HeartStart OnSite, and the HeartStart First Aid Defibrillator. This information is subject to change. Please contact Philips at www.philips.com/ productdocumentation or your local Philips representative for information on revisions.
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CONTENTS 1 INTRODUCTION TO THE HEARTSTART ONSITE Description ........................................................................................................... Sudden Cardiac Arrest ...................................................................................... Indications for Use ............................................................................................. Training and practice ..........................................................................................
APPENDICES A Accessories for the HeartStart OnSite B Glossary of terms C Glossary of symbols/controls D Warnings and precautions E Technical information F Configuration H Additional technical information required for European conformity ii P HI L I P S M E D I C A L S Y S T E M S G Testing and troubleshooting
1 1 INTRODUCTION TO THE HEARTSTART DESCRIPTION The Philips HeartStart OnSite Defibrillator M5066A is part of the Philips HeartStart HS1 family of defibrillators. Small, lightweight, and battery powered, it is designed for simple and reliable operation. P H I L I P S M E DI C A L S Y S TE M S SUDDEN CARDIAC ARREST The OnSite is used to treat the most common causes of sudden cardiac arrest (SCA), including ventricular fibrillation (VF).
TRAINING AND PRACTICE The OnSite is one part of a well-designed emergency response plan. Any emergency response plan should be under the oversight of a physician and should include training in cardiopulmonary resuscitation (CPR). Philips recommends that you train on the device you will be using. Several national and local organizations offer combined CPR/defibrillator training. Contact your Philips representative, or visit us online at www.philips.
2 SETTING UP THE HEARTSTART ONSITE 2 PACKAGE CONTENTS P H I L I P S M E DI C AL S Y S TE M S Check the contents of the HeartStart OnSite Defibrillator M5066A box to be sure it contains: • 1 HeartStart OnSite Defibrillator • 1 battery M5070A • 1 Adult SMART Pads Cartridge M5071A, containing one set of adhesive defibrillation pads • 1 Owner’s Manual • 1 Quick Reference Guide • 1 Quick Start poster Training materials and optional accessories for the HeartStart OnSite are also available from Phi
3. Insert the cartridge into the cartridge well on the front of the OnSite It should click into place when properly seated. The green PULL handle should be all the way down. 55 + lb s / 25 + kg 55 + lb s / 25 + kg NOTE: To prevent the pads’ adhesive gel from drying out, do not open the hard cover or film seal of the cartridge until you need to use the pads. 4. top back 5. The OnSite will automatically run a self-test when the battery is inserted. Press the Shock button when instructed.
6. Place the OnSite in the carry case, pressing it firmly into place. Insert the Quick Reference Guide,* face up, in the clear plastic window on the inside of the case. If you purchased a spare SMART Pads Cartridge or an Infant/Child Pads Cartridge, place it in the storage area in the case. NOTE: Do not store anything in the defibrillator carry case that it is not designed to accommodate. Store all objects in their intended location in the case. P H I L I P S M E DI C A L S Y S TE M S 7.
RECOMMENDED ACCESSORIES It is always a good idea to have a spare battery and a spare pads set.
3 USING THE HEARTSTART ONSITE IMPORTANT NOTE: Be sure to read the Reminders section at the end of this chapter as well as the warnings and precautions in Appendix D. OVERVIEW P H I L I P S M E DI C A L S Y S TE M S If you think someone is in SCA, act quickly and calmly. If someone else is available, ask him or her to call for emergency medical assistance while you get the OnSite. If you are alone, follow these steps: • Call your emergency services provider.
STEP 1: PULL THE GREEN HANDLE Turn on the OnSite by pulling the SMART Pads Cartridge’s green handle.* Remove the hard cover from the pads cartridge and set it aside. Remain calm and follow the OnSite’s instructions. 55 + lb s / 25 + kg * You can also turn on the OnSite by pressing the green On/Off button. 3-2 P H I L I P S M E D I C A L S Y S TE M S The OnSite starts by directing you to remove all clothes from the patient’s chest.
STEP 2: PLACE THE PADS Pull the tab at the top of the pads cartridge to peel off the film seal. Inside are two adhesive pads on a plastic liner. Remove the pads from the cartridge. 3 P H I L I P S M E DI C A L S Y S TE M S Peel one pad off the liner. Place the pad on the patient’s bare skin, exactly as shown in the picture on the pad. Press the pad down firmly. Then repeat this with the other pad. Be sure the pads have been removed from the liner before placing them.
STEP 3: PRESS THE SHOCK BUTTON As soon as the OnSite detects that the pads are attached to the patient, it begins analyzing the patient’s heart rhythm. It tells you that no one should be touching the patient, and the Caution light begins flashing as a reminder. If a shock is needed: The Caution light goes from flashing to solid, the orange Shock button starts flashing, and the OnSite tells you to press the flashing orange button. Before you press the button, make sure no one is touching the patient.
TREATING INFANTS AND CHILDREN WARNING: Most cardiac arrests in children are not caused by heart problems. When responding to cardiac arrest in an infant or child: • Provide infant/child CPR while a bystander calls EMS and brings the OnSite. • If no bystander is available, provide 1-2 minutes of CPR before calling EMS and retrieving the OnSite. • If you witnessed the child's collapse, call EMS immediately and then get the OnSite. 3 Alternatively, follow your local protocol.
If the patient is under 55 pounds or 8 years old, but you do NOT have an Infant/Child Pads Cartridge: • DO NOT DELAY TREATMENT. • Remove all clothing from the torso, to bare both the chest and the back. • Apply the OnSite using the adult pads cartridge, but place one pad in the center of the chest between the nipples, and the other in the center of the back (anterior-posterior). If the patient is over 55 pounds or 8 years old, or if you are not sure of the exact weight or age: DO NOT DELAY TREATMENT.
REMINDERS • Remove any medicine patches and residual adhesive from the patient’s chest before applying the pads. • Do not allow the pads to contact other electrodes or metal parts that are in contact with the patient. • Avoid placing the pads directly over an implanted pacemaker or defibrillator. A noticeable lump with a surgical scar should indicate the position of an implanted device. P H I L I P S M E DI C A L S Y S TE M S • If the pads do not stick well, check that the pads adhesive has not dried out.
NOTES P H I L I P S M E D I C A L S Y S TE M S
4 AFTER USING THE HEARTSTART ONSITE P H I L I P S M E DI C A L S Y S TE M S AFTER EACH USE 1. Check the outside of the OnSite for signs of damage, dirt, or contamination. If you see signs of damage, contact Philips for technical support. If the OnSite is dirty or contaminated, clean it according to the guidelines in Chapter 5, “Maintaining the HeartStart.” 2. Insert a new SMART Pads cartridge into the OnSite. Check supplies and accessories for damage and expiration dates.
Follow your local protocol with regard to prompt data transfer for medical review after using the OnSite.* Details about data transfer and timing are provided in Event Review documentation. The information automatically stored by the OnSite includes a summary of last-use data and detailed data about its last clinical use. You can get a voice summary of information about the last use of the OnSite by holding the i-button down until it beeps once.
5 MAINTAINING THE HEARTSTART ONSITE ROUTINE MAINTENANCE The OnSite is very simple to maintain. The OnSite performs a self-test every day. In addition, a battery insertion self-test is run whenever a battery is installed in the device. The OnSite’s extensive automatic self-test features eliminate the need for any manual calibration. The OnSite has no user-serviceable parts. WARNING: Electrical shock hazard. Do not open the OnSite, remove its covers, or attempt repair.
CLEANING THE ONSITE The outside of the OnSite and its carry case can be cleaned with a soft cloth dampened in soapy water, chlorine bleach (2 tablespoons per quart or liter of water), or ammonia-based cleaners. REMINDERS: • Do not use isopropyl (rubbing) alcohol, strong solvents such as acetone or acetone-based cleaners, abrasive materials, or enzymatic cleaners to clean your OnSite. • Do not immerse the OnSite in fluids or allow fluids to spill onto it. • Do not sterilize the OnSite or its accessories.
A A ACCESSORIES FOR THE HEARTSTART ONSITE Accessories* for the HeartStart OnSite Defibrillator available separately from your Philips representative or on-line at www.philips.
• Training • Adult Training Pads Cartridge [REF: M5073A] • Adult Training Replacement Pads [REF: M5093A] • Adult Pads Placement Guide [REF: M5090A] • Infant/Child Training Pads Cartridge [REF: M5074A] • Infant/Child Training Replacement Pads [REF: M5094A] • Infant/Child Pads Placement Guide [REF: 989803139281] • HeartStart OnSite Instructor's Training Toolkit [REF: M5066-89100] • HeartStart Trainer [REF: M5085A] • Internal Manikin Adapter [REF: M5088A] • External Manikin Adapter, 5 pack
B GLOSSARY OF TERMS B The terms listed in this Glossary are defined in the context of the Philips HeartStart OnSite Defibrillator and its use. AED AED mode analysis P H I L I P S M E DI C A L S Y S TE M S arrhythmia Automated external defibrillator (a semi-automatic defibrillator). The standard treatment mode for the HeartStart OnSite Defibrillator. It provides voice instructions guiding the rescuer through applying the adhesive pads, waiting for rhythm analysis, and delivering a shock if needed.
HeartStart Event Review i-button infrared communications A suite of data management software applications for use by trained personnel to review and analyze HeartStart OnSite Defibrillator patient use and by authorized personnel to alter OnSite configuration. Information is available from Philips Medical Systems on the internet at www.philips.com/eventreview. A blue “information” button on the front of the HeartStart OnSite Defibrillator.
periodic self-tests protocol A sequence of operations performed by the HeartStart OnSite Defibrillator to direct patient care in the AED mode. protocol pause A pause provided by the HeartStart OnSite Defibrillator after a shock series, during which the responder can administer CPR. The OnSite does not conduct background monitoring of the patient’s heart rhythm during this pause.
standard NSA pause sudden cardiac arrest (SCA) waveform See “NSA pause.” The sudden stopping of the heart’s pumping rhythm, accompanied by loss of consciousness, absence of respiration, and lack of a pulse. See “SMART biphasic waveform.
C GLOSSARY OF SYMBOLS/CONTROLS symbol description Pads cartridge handle. Green. Pulling the handle turns on the OnSite and opens pads cartridge for use. P H I L I P S M E DI C A L S Y S TE M S Refer to operating instructions. On/Off button. Green. Pressing the On/Off button when the OnSite is in standby mode turns the OnSite on; pressing and holding the On/Off button for one second when the OnSite is on turns the OnSite off and disarms the defibrillator.
symbol description Indicates that this device is optimized for Guidelines 2005. Certified by the Canadian Standards Association. Reference order number. Authorized representative in the European Community. Expiration date. Lithium manganese dioxide battery. Do not crush the battery. Do not expose the battery to high heat or open flames. Do not incinerate the battery. Do not mutilate the battery or open the battery case. Class 9 miscellaneous dangerous goods.
symbol description This side up. Transportation requirements (refer to associated thermometer symbol). Storage requirements (refer to associated thermometer symbol). P H I L I P S M E DI C A L S Y S TE M S Environmental (temperature and relative humidity) requirements. These pads are disposable and are for single patient use only. Cartridge contents: one set of two defibrillation pads. Store the pads at temperatures between 0° and 43° C (32° and 110° F).
symbol description Lot number. Federal law (USA) restricts this device to sale by or on the order of a physician. Dispose of in accordance with your country's requirements. Printed on recycled paper.
D WARNINGS AND PRECAUTIONS It is important to understand how to use your HeartStart OnSite Defibrillator safely. Please read these warnings and precautions carefully. A warning describes something that could cause serious personal injury or death. A precaution describes something that could cause minor personal injury, damage to the OnSite, loss of data stored in the OnSite, or less chance of successful defibrillation.
pads Do not allow the pads to contact other electrodes or metal parts that are in contact with the patient. PRECAUTIONS device handling maintenance Improper maintenance may damage the OnSite or cause it to function improperly. Maintain the OnSite according to directions. skin burns Do not let the pads touch each other or other electrodes, lead wires, dressings, medicine patches, etc.
E TECHNICAL INFORMATION HEARTSTART ONSITE DEFIBRILLATOR SPECIFICATIONS The specifications provided in the following tables are nominal values. Additional information can be found in the Technical Reference Manuals for HeartStart Automated External Defibrillators, located online at www.philips.com/ productdocumentation. PHYSICAL category P H I L I P S M E DI C A L S Y S TE M S size weight specifications 2.80” H x 7.40” D x 8.30” W (7.1cm H x 19cm D x 21cm W). Approximately 3.3 lbs (1.
category sealing ESD/EMI (radiated and immunity) specifications Drip proof per EN60529 class IPx1. Solid Objects per EN60529 class IP2x. See Electromagnetic Conformity tables. CONTROLS AND INDICATORS category controls audio speaker beeper E-2 Green SMART Pads cartridge handle Green On/Off button Blue i-button Orange Shock button Ready light: green; blinks when the OnSite is in standby mode (ready for use); solid when the defibrillator is being used.
DEFIBRILLATION WAVEFORM category P H I L I P S M E DI C A L S Y S TE M S waveform parameters specifications Biphasic truncated exponential. Waveform parameters are automatically adjusted as a function of patient defibrillation impedance. In the diagram at left, D is the duration of phase 1 and E is the duration of phase 2 of the waveform, F is the interphase delay (500 μs), and Ip is the peak current. The HeartStart delivers shocks to load impedances from 25 to 180 ohms.
category energy* (pediatric doses indicated are based on CDC growth charts for the 50th percentile weights for boys.) specifications Using HeartStart Adult SMART Pads: 150 J nominal (±15%) into a 50 ohm load. Using HeartStart Infant/Child SMART Pads: 50 J nominal (±15%) into a 50 ohm load.
ECG ANALYSIS SYSTEM category specifications function Evaluates impedance of adhesive pads for proper contact with the patient’s skin, and evaluates the ECG rhythm and signal quality to determine if a shock is appropriate. shockable rhythms Ventricular fibrillation (VF) and some ventricular tachycardias associated with a lack of circulation, including ventricular flutter and polymorphic ventricular tachycardia (VT). The HeartStart uses multiple parameters to determine if a rhythm is shockable.
ECG ANALYSIS PERFORMANCE rhythm class ECG test samplea size meets AHA recommendationsb for adult defibrillation observed 90% one-sided performance lower confidence limit 300 sensitivity >90% (meets AAMI DF80 requirement) (87%) shockable rhythm — ventricular tachycardia 100 sensitivity >75% (meets AAMI DF80 requirement) (67%) non-shockable rhythm — normal sinus rhythm 300 specificity >99% (meets AAMI DF80 requirement) (97%) non-shockable rhythm — asystole 100 specificity >95% (meets AAMI DF8
ACCESSORIES SPECIFICATIONS BATTERY M5070A category battery type capacity shelf life (prior to insertion) standby life (after insertion) P H I L I P S M E DI C A L S Y S TE M S training life specifications 9 VDC, 4.2 Ah, lithium manganese dioxide. Disposable, long-life primary cell. When new, a minimum of 200 shocks or 4 hours of operating time at 77° F (25° C).
ENVIRONMENTAL CONSIDERATIONS By complying with your national regulations regarding disposal of electric, electronic, and battery waste, you can make a positive contribution to our shared environment. Such waste can introduce harmful elements into the environment as a whole and may also endanger human health. product defibrillator The defibrillator contains electronic components. Do not dispose of it as unsorted municipal waste.
F CONFIGURATION OVERVIEW The Philips HeartStart OnSite Defibrillator comes with a factory default configuration designed to meet the needs of most users. This configuration can only be changed by an authorized person using HeartStart Configure software. This software is for use by trained personnel. Information about HeartStart data management products is available online at www.philips.com/eventreview.
PATIENT TREATMENT PROTOCOL OPTIONS parameter “call EMS” voice reminder timing shock series settings default default description • At power on (when the user turns on the OnSite) • At power on and at the start of the first patient care pause • At the start of the first patient care pause • No reminder At the start of the first patient care pause Provides a voice reminder to make sure emergency medical services have been called, at the start of the first patient care pause.
parameter P H I L I P S M E DI C A L S Y S TE M S protocol pause timer (minutes) NSA pause type settings default default description 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 2.0 A 2-minute protocol pause for CPR automatically starts after voice instruction is given when a shock series is completed. After the protocol pause, the OnSite returns to rhythm analysis.
parameter NSA pause timer (minutes) default default description 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 2.0 A 2-minute NSA pause for CPR automatically starts after voice instruction is given when no shock is advised (NSA).* If the user presses the i-button for optional CPR coaching, the OnSite provides coaching for 5 cycles of CPR, starting and ending with compressions, when the CPR Coaching parameters are also set to their default values.
P H I L I P S M E DI C A L S Y S TE M S parameter settings default default description CPR Coaching adult ventilation instruction Yes, No Yes Optional CPR Coaching includes rescue breaths at the rate determined by the CPR Coaching compression:ventilation ratio for adults when an adult pads cartridge is installed. NOTE: if this parameter is configured to NO, CPR Coaching will always be compressions-only when an adult pads cartridge is installed.
NOTES P H I L I P S M E D I C A L S Y S TE M S
G TESTING AND TROUBLESHOOTING TESTING P H I L I P S M E DI C A L S Y S TE M S As long as a battery is installed, the HeartStart OnSite Defibrillator automatically tests itself every day and alerts you if it finds a problem. The self-test includes pads readiness testing. In addition, it runs a pads self-test each time a pads cartridge is inserted. It alerts you if it finds a problem. See the Technical Reference Manual, available online at www.philips.
battery is available, remove the installed battery for five seconds, then reinsert it and run a battery insertion self-test. If the problem continues, do not use the OnSite. Attend to the patient, providing CPR if needed, until Emergency Medical Services Personnel arrive. TROUBLESHOOTING WHILE THE ONSITE IS IN USE (green Ready light is solid) OnSite tells you: recommended action The battery is nearly depleted. The OnSite will turn off if a new battery is not inserted.
OnSite tells you: ... to stop all motion possible cause • The patient is being moved or jostled. P H I L I P S M E DI C A L S Y S TE M S • The environment is dry and movement around the patient is causing static electricity to interfere with ECG analysis. • Radio or electrical sources are interfering with ECG analysis. recommended action • Stop CPR; do not touch the patient. Minimize patient motion. If the patient is being transported, stop the vehicle.
TROUBLESHOOTING WHILE THE ONSITE IS NOT IN USE (green Ready light is not on) behavior chirps or i-button flashes recommended action • The battery power is low or the SMART Pads cartridge needs to be replaced. • The OnSite may have been turned off without a pads cartridge installed, or the installed pads cartridge may not have its hard cover in place. • Press the blue i-button. Replace the battery or pads cartridge if instructed.
H ADDITIONAL TECHNICAL INFORMATION REQUIRED FOR EUROPEAN CONFORMITY ELECTROMAGNETIC CONFORMITY Guidance and manufacturer’s declaration: The HeartStart OnSite Defibrillator is intended for use in the electromagnetic environment specified in the tables below. The customer or user of the OnSite should assure that it is used in such an environment.
ELECTROMAGNETIC IMMUNITY immunity test electrostatic discharge (ESD) IEC 61000-4-2 power frequency (50/60 Hz) magnetic field IEC 61000-4-8 IEC 60601 test level compliance level electromagnetic environment guidance ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air There are no special requirements with respect to electrostatic discharge.a 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial/hospital environment.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE ONSITE The OnSite is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
IMPORTANT WARNINGS AND REMINDERS • Do not allow the pads to contact other electrodes or metal parts that are in contact with the patient. • Before delivering a shock, it is important to disconnect the patient from other medical electrical equipment, such as blood-flow meters, that may not incorporate defibrillation protections. In addition, make sure the pads are not in contact with metal objects such as a bedframe or stretcher.
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POWER TO S AVE A LIFE Philips Medical Systems is part of Philips Medical Systems Royal Philips Electronics United States Philips Medical Systems 2301 Fifth Avenue, Suite 200 Seattle, WA, USA 98121-1825 (800) 263-3342 Canada Philips Medical Systems 281 Hillmount Road Markham, Ontario L6C 2S3 (800) 291-6743 Europe, Middle East, and Africa Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Strasse 2 71034 Boeblingen, Germany +49 7031 463 2254 Latin America Philips