Summary of Contents for Philips HeartStart OnSite M5066A
Philips HeartStart OnSite AED Manual Get an original copy of the Philips HeartStart OnSite AED Manual for manufacturer information about service, available accessories and how to use and maintain your device.
H e a r t S t a r t O n S i t e D e f i b r i l l a t o r O W N E R ’ S M A N U A L Guide to Set Up, Operation, Maintenance, and Accessories M5066A Edition 14...
front view back view The HeartStart OnSite Defibrillator M5066A Pads Cartridge Handle. Information Button. Speaker. This When the device is Pull the handle to turn on the “i-button” flashes blue when it being used, its voice instructions HeartStart and remove the has information you can access by come from this speaker.
HeartStart OnSite M5066A Automated External Defibrillator O W N E R ’ S M A N U A L Edition 14 IMPORTANT NOTE: 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%.
Philips Medizin Systeme Boeblingen GmbH If you need technical support, please contact your local Hewlett-Packard Strasse 2 Philips representative by calling the regional number on 71034 Boeblingen, Germany the back cover of this manual, or go to (+49) 7031 463-2254 www.philips.com/AEDsupport.
CONTENTS 1 INTRODUCTION TO THE HEARTSTART ONSITE Description ....................... 1-1 Sudden cardiac arrest ..................1-1 Indications for use ..................1-1 Implementation considerations ..............1-2 For more information ..................1-2 2 SETTING UP THE HEARTSTART ONSITE Package contents ..................... 2-1 Setting up the OnSite ..................2-1 Recommended accessories ................
APPENDICES A Accessories for the HeartStart OnSite B Glossary of terms C Glossary of symbols/controls D Warnings and precautions E Technical information Configuration G Testing and troubleshooting H Additional technical information required for European conformity...
INTRODUCTION TO THE HEARTSTART ONSITE DESCRIPTION The Philips HeartStart OnSite Defibrillator M5066A (“OnSite”) is part of the Philips HeartStart HS1 family of automated external defibrillators (AEDs). Small, lightweight, and battery powered, the OnSite is designed for simple and reliable operation.
(CPR). Several national and local organizations offer combined CPR/AED training. Philips recommends that you train on the device you will be using. Contact your Philips representative for information, or visit us online at www.philips.com/ AEDservices to learn about certified training and web-based refresher training (offered in select areas) available through Philips AED Services.
SMART Pads Cartridge. Training materials and optional accessories for the HeartStart are also available from Philips. See Appendix A for information. SETTING UP THE HEARTSTART ONSITE Setting up the OnSite is simple and quick. The HeartStart Quick Setup Guide provides illustrated instructions for setup, which is described in detail below.
Quick Reference Guide is face up in the clear plastic window on the inside of the carry case. Philips recommends that you store a spare pads cartridge and spare battery with your OnSite. If you are using a standard carry case,...
Use the maintenance provided to record the expiration date of EXP. 09/2010 DATE the installed pads INSTL. DATE cartridge. If you have a spare pads cartridge EXP. EXP. EXP. 09/2010 09/2010 09/2010 DATE DATE DATE EXP. DATE INSTALL 08-2011 INSTALL 08-2011 BEFORE BEFORE...
— to dry the victim's skin for good pads contact Philips has a Fast Response Kit with all these items. See Appendix A for information. If you may need to defibrillate an infant or a child under 25 kg (55 pounds) or 8 years old, it is recommended that you order the infant/child SMART Pads cartridge, available separately.
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 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.
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. 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. Peel one pad off the liner. Place the pad on the patient’s bare skin, exactly as shown in the picture on the pad.
* The default configuration for the OnSite provides CPR Coaching when you press the i-button in this situation; however, the default setting can be revised by your Medical Director using Philips software available separately. See Appendix F for more information.
CPR Coaching. Place the pads exactly as shown on the illustration on the pads. * Philips recommends that the OnSite be stored with an adult pads cartridge installed, as pediatric cardiac arrest is not common. † This lower energy level may not be effective for treating an adult.
If the patient is under 25 kg (55 pounds) or 8 years old, but you do NOT have an infant/child SMART Pads Cartridge: • DO NOT DELAY TREATMENT. • Remove all clothing from the torso, to bare both the chest and the back.
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.
AFTER EACH USE 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 OnSite.”...
Unless your protocol requires that the battery remain installed, remove the battery for five seconds, then reinstall it to run the battery insertion self- test to check the operation of the OnSite. When the test is complete, check that the green Ready light is blinking. back Battery installation.
The stored data can be conveniently transferred to a personal computer or a handheld computer running the appropriate application in the Philips HeartStart Event Review data management software suite. Event Review software is for use by trained personnel only. Information about HeartStart Event Review is available online at www.philips.com/eventreview.
WARNING: Electrical shock hazard. Do not open the OnSite, remove its covers, or attempt repair. There are no user-serviceable components in the OnSite. If repair is required, return the OnSite to Philips for service. REMINDERS: • Do not leave the OnSite without a pads cartridge installed; the OnSite will start chirping and the i-button will start flashing.
• If the Ready light is off, and the OnSite is emitting a series of triple chirps, please call Philips for technical support. See “Troubleshooting a chirping HeartStart” on page 5-3 for more information. • If the Ready light is off but the OnSite is not chirping and the i-button is not flashing: there is no battery inserted, the battery is depleted, or the OnSite needs repair.
If you ever hear your AED emit a series of triple chirps: • in stand-by mode — please call Philips immediately for technical support at the regional number listed on the back cover of this manual. •...
ACCESSORIES FOR THE HEARTSTART ONSITE Accessories for the HeartStart OnSite Defibrillator available separately from your Philips representative or on-line at www.philips.com/heartstart include: • Battery (spare recommended) [REF: M5070A] • Pads • Adult SMART Pads Cartridge (spare recommended) [REF: M5071A] •...
• Data Management Software • HeartStart Configure [REF: 861487] • HeartStart Data Messenger [REF: 861451] • HeartStart Event Review [REF: 861489] • HeartStart Event Review Pro [REF: 861431] • HeartStart Event Review Pro, upgrade [REF: 861436] • Infrared cable for use with HeartStart Event Review software [REF: ACT-IR] •...
GLOSSARY OF TERMS The terms listed in this Glossary are defined in the context of the Philips HeartStart OnSite Defibrillator and its use. Automated external defibrillator (a semi-automatic defibrillator). AED mode The standard treatment mode for the OnSite. 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 A suite of data management software applications for use by trained personnel to review and analyze OnSite patient use and by authorized personnel to alter OnSite configuration. Information is available from Philips Healthcare on the internet at www.philips.com/eventreview. i-button An “information”...
periodic self-tests Daily, weekly, and monthly tests automatically conducted by the OnSite when it is in its standby mode. The tests monitor many key functions and parameters of the OnSite, including battery capacity, pads cartridge readiness, and the state of its internal circuitry.
standard NSA pause See “NSA pause.” sudden cardiac arrest Sudden cardiac arrest is the abrupt cessation of the heart’s normal pumping of (SCA) blood, frequently caused by an electrical malfunction in the heart. SCA results in a stoppage of blood flow, absent or abnormal breathing, and unconsciousness. waveform See “SMART biphasic waveform.”...
GLOSSARY OF SYMBOLS/CONTROLS symbol description Pads cartridge handle. Green. Pulling the handle turns on the OnSite and opens pads cartridge for use. Refer to operating instructions. On/Off button. Green. Pressing the On/Off button when the OnSite is in standby mode turns the OnSite on;...
symbol description Meets the requirements of the applicable European Directives, including RoHS Directive 2011/65/EU, The Restriction of the Use of Certain Hazardous Sub- stances in Electrical and Electronic Equipment. Meets the requirements of the European Medical Device Directive 93/42/EEC. The four numerical digits indicate the identification number of the Notified Body involved in assessing the product’s conformity with the directive.
symbol description Class 9 miscellaneous dangerous goods. (Symbol required on outer packaging by freight carrier regula- tions to identify shipments containing lithium batteries.) Install the battery in the defibrillator before the date (MM-YYYY) shown on the associated label. Needs to be protected from moisture. Handle with care.
symbol description Store the pads at temperatures between 0° and 50° C (32° and 122° F). This product is not sterile. N ON - S TERI LE This product is not made with natural rubber latex. LAT EX Pads intended for use on infant or child under 8 years or 25 Kg (55 lb).
OnSite, loss of data stored in the OnSite, or less chance of successful defibrillation. NOTE: The HeartStart OnSite Defibrillator is designed to be used only with Philips-approved accessories. The OnSite may perform improperly if non- approved accessories are used. WARNINGS...
pads Do not allow the pads to contact other electrodes or metal parts that are in contact with the patient. children Keep the HeartStart out of reach of children to avoid the potential risk of inhalation or swallowing of small parts or strangulation by pads cables. PRECAUTIONS device handling The OnSite was designed to be sturdy and reliable for many different use...
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/ productdocs. PHYSICAL category specifications size 7.2cm H x 19cm D x 21cm W (2.85”...
category specifications vibration Operating: meets EN1789 random, road ambulance. Standby: meets EN1789 swept sine, road ambulance. sealing Meets IEC 60529 class IP21. Protected against access to hazardous parts with a finger and protected against ingress of solid foreign objects of 1.25 cm (0.5 in) diameter and greater per IEC 60529 class IP2x.
DEFIBRILLATION WAVEFORM category specifications waveform parameters 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.
category specifications energy* Using HeartStart Adult SMART Pads: 150 J nominal ( 15%) into a 50 ohm (pediatric doses indicated load. Using HeartStart Infant/Child SMART Pads: 50 J nominal ( 15%) into a are based on CDC growth 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).
From Philips Medical Systems ECG rhythm databases. b. American Heart Association (AHA) AED Task Force, Subcommittee on AED Safety & Efficacy. Automatic External Defibrillators for Public Access Use: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporation of New Waveforms, and Enhancing Safety.
ACCESSORIES SPECIFICATIONS BATTERY M5070A category specifications battery type 9 VDC, 4.2 Ah, lithium manganese dioxide. Disposable, long-life primary cell. capacity When new, a minimum of 200 shocks or 4 hours of operating time at 25° C (77° F). shelf life A minimum of 5 years from date of manufacture when stored and maintained (prior to insertion) according to directions provided in this Owner’s Manual.
Substances of Very High Concern (SVHC) if they are present above 0.1% of the article weight. The SVHC list is updated on a regular basis. Therefore, refer to the following Philips REACH website for the most up-to-date list of products containing SVHC above the threshold:...
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 settings default default description “call EMS” voice • At power on (when At the start of Provides a voice reminder to make reminder timing the user turns on the first patient sure emergency medical services the OnSite) care pause have been called, at the start of the...
parameter settings default default description protocol pause timer 0.5, 1.0, 1.5, A 2-minute protocol pause for CPR (minutes) 2.0, 2.5, 3.0 automatically starts after voice instruction is given when a shock series is completed. After the protocol pause, the defibrillator returns to rhythm analysis.
parameter settings default default description NSA pause timer 0.5, 1.0, 1.5, A 2-minute NSA pause for CPR (minutes) 2.0, 2.5, 3.0 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...
parameter settings default default description CPR Coaching Yes, No Optional CPR Coaching includes adult ventilation rescue breaths at the rate instruction 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.
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 Manuals, available online at www.philips.com/productdocs, for a detailed discussion of the self-tests.
defibrillator. If no spare 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:...
OnSite tells you: possible cause recommended action ... to stop all motion • The patient is being moved or • Stop CPR; do not touch the jostled. patient. Minimize patient motion. If the patient is being transported, stop the vehicle. •...
NOTE: In the event of a triple-chirp alert, even if the failure is cleared by a battery insertion test, please contact Philips for service. In the event of repeated instances of a self-test failure resulting in single-chirp alerts, even if such failures are cleared by a battery insertion test, please contact Philips for service. behavior...
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.
Generally, AEDs are sometimes susceptible to interference generated by patient and/or responder motion in environments in which a high static electric field is present (e.g., low humidity, synthetic carpets, etc.). As a safety measure, Philips AEDs incorporate a patented method to sense possible corruption of the ECG signal by such interference and to respond by directing the user to stop all motion.
immunity test IEC 60601 compliance level electromagnetic environment - test level guidance d = 0.60 √ P radiated RF 10 V/m 20 V/m IEC 61000-4-3 80 MHz to 80 MHz to 800 MHz 2.5 GHz d = 1.2 √ P 80 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in...
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. The customer or the user of the OnSite can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OnSite as recommended below, according to the maximum output power of the communications equipment.
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.