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Table of contents for the manual
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HeartStart OnSite Defibrillator OWNER’S MANUAL Guide to Set Up, Operat ion, Maintenance, and Acces sories M5066A Edition 8[...]
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PHILIPS MEDICAL SYS TEMS Intentionally blank.[...]
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PHILIPS MEDICAL SYSTEMS The Hear tStar t OnSite Def ibr illator M5066A Pads Cartri dge Handle. Pull the handle to turn on the Hear tStar t and remov e the ca r trid ge ’ s h ard cover . Ready Light. This green light tells you the r ead iness of the Hear tStar t. Blinking: standby mode (ready for use) Solid: in use Off: needs attention (HeartStar [...]
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PHILIPS MEDICAL SYS TEMS Intentionally blank.[...]
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PHILIPS MEDICAL SYS TEMS Hear tStar t OnSite Def ibr illator Q UICK REFERENCE[...]
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PHILIPS MEDICAL SYS TEMS Hear tStar t OnSite M5066A Automated Exter nal Defibrillator Edition 8 IMPOR T ANT NO TE: It is impor tant to understand that sur vival rates for sudden cardiac arr est are d irectly r elated to how soon victims r eceive tr eatment. For e v er y minute of dela y , the chance of sur vival declines by 7% to 10%. T reatment ca[...]
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PHILIPS MEDICAL SYSTEMS Intentionally blank.[...]
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PHILIPS MEDICAL SYS TEMS About this edition The information in this gui de applies to the model M5066A Hear tStar t OnSite Defibrillator . Its technical contents apply to all models in the HeartStart HS1 family of defibr illators, including the HeartS tart, the HeartSta rt OnSite , and the Hear tStar t First Aid Defibrillator . This information is [...]
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PHILIPS MEDICAL SYSTEMS Intentionally blank.[...]
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i PHILIPS MEDICAL SYSTEMS CONTENTS 1 INTRODUCTION TO THE HEARTSTART ONSITE Description .......................................... ................................................. ................ 1-1 Sudden Cardiac Arrest . ................................................. .................................... 1-1 Indications for Use ..............[...]
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PHILIPS MEDICAL SYSTEMS ii APPENDICES A Accessories for the HeartStart OnSi te B Glossary of terms C Glossary of sy mbols/controls D Warnings and precautions E Technical information F Configuration G Testing and troubleshooting H Additional technical informatio n required for European conformity[...]
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PHILIPS MEDICAL SYSTEMS 1-1 1 1 INTRODUCTION TO THE HEAR TSTAR T DESCRIPTION The Philips HeartStar t OnSite Defibr illator M5066A is part of the Philips HeartStar t HS1 family of defibr illators. Sm all, lightw eight, and battery p ow ered, it is designed for simple and r eliable operation. SUDDEN CARDIAC AR REST The OnSite is used to treat the mos[...]
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PHILIPS MEDICAL SYS TEMS 1-2 T R AINING AND PR ACTICE The OnSite is on e part of a well-designed emergency response plan. Any emergency response plan should be under the oversight of a ph ysician and should include training in cardiopulmonary resuscitation (CPR). Philips recommends t hat you train on the de vice you will be using. Sev eral national[...]
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PHILIPS MEDICAL SYSTEMS 2-1 2 2 SETTING UP THE HEAR TSTAR T ONSITE PACKAGE CONTENTS Check the contents of the Hear tStar t OnSite Defibrillator M5066A box to be sur e it contains: • 1 Hear tStar t OnSite Defibrillator • 1 battery M5070A • 1 Adult SMAR T Pads Cartridge M5071A, containing one set of adhesive defibr illation pads •1 O w n e r [...]
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PHILIPS MEDICAL SYS TEMS 2-2 3. Insert the car tridge into the cartridge well on the fr ont of the OnSite It should click into place when properly seated . The green PULL handle should be all the wa y down. NO TE: T o pre vent the pads’ adhesive gel fr om drying out, do not open the hard cov er or film seal of the car tridge until y ou need to us[...]
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2-3 PHILIPS MEDICAL SYSTEMS 2 6. Place the OnSite in the carry case, pre ssing it firmly into place . Inser t the Quick Refer ence Guide, * face up, in the clear plasti c windo w on the inside of the case . If you pur chased a spare SMAR T Pa ds Cartridge or an Infant/Child Pads Cartridge, place it in the storage area in the case. NO TE: Do not sto[...]
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PHILIPS MEDICAL SYS TEMS 2-4 RECOMMENDED ACCESSOR IES It is alwa ys a good idea to ha v e a spare battery and a spare pads set. Other things that are useful to k eep with the OnSite include: • scissors — for cutting the victim’ s clothes if needed • disposable glov es — to pr otect the user • a disposable razor — to sha ve the chest i[...]
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PHILIPS MEDICAL SYSTEMS 3-1 3 3 USING THE HEAR TSTAR T ONSITE IMPOR T ANT NO TE: Be sure to read the Reminders section at the end of t his chapter as w ell as the warnings and pr ecautions i n Append ix D . OVER VIEW If you think someone is in SC A, act quickly and calmly . If someone else is available , ask him or her to call for emergency medi ca[...]
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PHILIPS MEDICAL SYS TEMS 3-2 STEP 1: PULL THE GREEN HANDLE T urn on the OnSite by pulling the SMAR T Pads Cartridge’ s gr een handle. * Remove the hard cover fr om the pads cartridge an d set it aside. Remain calm and follow the OnSite’ s instructions. The OnSite star ts by directing you to r emove all clothes fr om the patient’ s chest. If n[...]
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3-3 PHILIPS MEDICAL SYSTEMS 3 STEP 2: PLA CE THE PADS Pull the tab at the to p of the pads cartridge to peel off the film seal. Inside ar e tw o adhesive pads on a plastic liner . Remov e the pads from the cartri dge. Pe el one pad off the liner . Place th e pad on the patient’ s bare skin, exactly as shown in the picture on the pad . Press the p[...]
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PHILIPS MEDICAL SYS TEMS 3-4 STEP 3: PRESS THE SHOCK BUTTON As soon as the O nSite detects that the pads are attached to the patient, it be gins analyzing the patient’ s hear t rh ythm. It tell s you that no one should be touching the patient, and the Caution light be gins flashing as a reminder . If a shock is needed: The Caution light goes fr o[...]
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3-5 PHILIPS MEDICAL SYSTEMS 3 T REATING INFANTS AND CHILDREN W ARNING: Most cardiac arr ests in childr en ar e not caused by he art problems. Wh e n re sp o nd in g to ca rdi a c a r rest in an in fant or child: • Provi de infant/child CPR while a b ystander calls EMS and brings the OnSite. • If n o bystander is available, pro vide 1-2 minutes [...]
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PHILIPS MEDICAL SYS TEMS 3-6 If the patient is under 55 pounds or 8 years old, but you do NO T have an Infant/Child P ads Car tri dge: • DO NO T DELA Y TREA TMENT . • Remove all clothing fr om the torso , to bar e both the chest and the back. • Apply the OnSite usin g the adult pads car tridge, but place one pad in the center of the chest bet[...]
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3-7 PHILIPS MEDICAL SYSTEMS 3 REMINDER S • Remove any medicine patches and re sidual adhesive fr om the patient’ s chest befor e applying the pads. • Do not allow the pads to contact other electrodes or met al par ts that are in contact with the patient. • Av oi d placing the pads directly ov er an implanted pacemak er or def ibrillator . A[...]
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PHILIPS MEDICAL SYS TEMS NOTES[...]
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PHILIPS MEDICAL SYSTEMS 4-1 4 4A F T E R U S I N G T H E HEAR TSTAR T ONSITE AFTER EACH USE 1. Check the outside of the OnSite for signs of damage, dir t, or contamination. If you see signs of damage, contact Philips for technical support. If the OnSite is dirty or contaminated, clean it accord ing to the guidelines in Cha pter 5, “Maintaining th[...]
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PHILIPS MEDICAL SYS TEMS 4-2 Follo w your local pr otocol with r egar d to pr ompt data transfer for med ical re vie w after using the OnSite. * Details about data tra nsfer and timing are pr ovi ded in Event Re view documentation. The information automaticall y stored b y th e OnSite includes a summar y of last-use data and detailed data about its[...]
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PHILIPS MEDICAL SYSTEMS 5-1 5 5 MAINTAINING THE HEAR TSTAR T ONSITE ROUTINE MAINTENANCE The OnSite is ver y simple to maintain . The OnSite performs a self-test every da y . In additi on, a battery inser tion self-test is run whenev er a battery is installed in the device. The OnSite’ s extensive automatic se lf-test featur es eliminate the need [...]
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PHILIPS MEDICAL SYS TEMS 5-2 CLEANING THE ONSITE The outside of the OnSite and its carry case can be cleaned with a soft cloth dampened in soap y water , chlorine bleach (2 tablespoons per quart or liter of water), or ammonia-based cleaners. REMINDERS: • Do not use isoprop yl (rubbing) alcohol , strong solv ents such as acetone or acetone-based c[...]
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PHILIPS MEDICAL SYSTEMS A-1 A A ACCESSOR IES FOR THE HEAR TSTAR T ONSITE Accessories * f or the HeartStar t OnSite Defibr illator a vailable separately fr om y our Philips repr esentati ve or on-lin e at www .philips.com/heartstart include: • Batter y (spare r ecommended) [REF: M5070A] •P a d s • Adult SMAR T Pads Cartridge (spar e recomme nd[...]
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PHILIPS MEDICAL SYS TEMS A-2 • T rain ing • Adult T raining Pads Cartridge [REF: M5073A] • Adult T raining Replacement Pads [REF: M5093A] • Adult Pads Placement Guide [REF: M5090A] • Infant/Child T ra ining Pads Cartridge [REF: M5074A] • Infant/Child T ra ining Replacement Pads [REF: M5094A] • Infant/Child Pads Placement Guide [REF: 9[...]
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PHILIPS MEDICAL SYSTEMS B-1 B B GLOSSAR Y OF TER MS The terms listed in this G lossar y are de fined in the context of the Philips Hear tStart OnSite Defibrillator and its use . AED Automated external def ibril lator (a semi-automatic defibr illator). AED mode The standard treatment mode for the Hear tStar t OnSite Defibrillator . It provides voice[...]
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PHILIPS MEDICAL SYS TEMS B-2 HeartSta rt Event Review A suite of data management so ftware a pplications for use b y trained personnel to re view and analyze HeartStar t OnSite Defi brillator patient use and by authorized personnel to alter OnSite configuration. Information is a vailable from Philips Medical Systems on the inte rnet at www .philips[...]
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B-3 PHILIPS MEDICAL SYSTEMS B period ic self-tests Daily , w eekly , and monthly tests automatically conducted b y the HeartStart OnSite Defibrillator when it is in its sta ndby mode. The test s monitor many k ey functions and parameters of the OnSi te, in cluding batter y capacity , p ads cartridge readiness, and the state of its internal cir cuit[...]
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PHILIPS MEDICAL SYS TEMS B-4 standard NSA pause See “NSA pause . ” sudden car diac ar r est (SC A) The sudden stopping of the hear t’ s pum ping rh ythm, accompanied by loss of consciousness, absence of resp iration, and lack of a pul se. wa v eform See “SMA R T b iphasic wav e form. ”[...]
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PHILIPS MEDICAL SYSTEMS C-1 C C GLOSSAR Y OF SYMBOLS/CONTROLS symbol description Pads cartridge handle. Green. Pulling the handle turns on the OnSite and opens pads cart ri dge for use. Refer to operating instructions. On/Off button. Green. Pr essing the On/Off button when the OnSite is in stan dby mode turns the OnSite on; pressing and holding the[...]
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PHILIPS MEDICAL SYS TEMS C-2 Indicates that this device is optimized for Guidelines 2005. Certified by the Canadian Standar ds Association. Refer ence or der number . Authorized r epresentativ e in the Eur opean Comm unity . Expiration date . Lithium manganese dio xide battery . One batter y in package. Do not crush the batter y . Do not expose the[...]
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C-3 PHILIPS MEDICAL SYSTEMS C This side up . T ranspor tation requir ements (refer to associated ther - mometer symbol). Storage requir ements (r efer to associated thermometer symbol). Envir onmental (temperatur e and r elativ e humidit y) requir ements. These pads are di sposable and are f or single patient use only . Cartridge contents: one set [...]
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PHILIPS MEDICAL SYS TEMS C-4 Lot number . Federal la w (USA) restricts this device to sale b y or on the order of a ph ysician. Dispose of in accordance with y our country's requir e- ments. Printed on r ecycled paper . symbol description[...]
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PHILIPS MEDICAL SYSTEMS D-1 D D W AR NINGS AND PRECAUTIONS It is importan t to understand how to use your HeartStar t OnSite Defibrillator safely . Please r ead these warnings and pr ecautions carefully . A warning describes something that could cause serious personal injury or death. A precaution descr ibes something that could cause minor persona[...]
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PHILIPS MEDICAL SYS TEMS D-2 pads Do not allow the pads to contact other electr odes or metal parts that are in contact with the patient. PRECAUTIONS device handling The OnSi te was designed to be stur dy and r eliable f or many d iff erent use conditions. How ev er , handling the OnSite too roughly can damage it or its accessories and will in vali[...]
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PHILIPS MEDICAL SYSTEMS E-1 E E T ECHNICAL INFOR MATION HEAR TSTAR T ONSITE DEFIBRILLATOR SPECIFICATIONS The specifications pr ovided in the f ollow ing tables are nominal values. Additional information can be found in the T ec hnical Reference Manuals for HeartStar t Automated External Defibrillators, located online at www .philips.com/ productdoc[...]
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PHILIPS MEDICAL SYS TEMS E-2 CONTROLS AND INDICATOR S sealing Drip pr oof per EN60529 class IPx1. Solid Objects per EN60529 class IP2x. ESD/EMI (radiated and immunity) See Electr omagnetic Conformity tables. categor y specifications category specification s controls Green SMAR T Pads car tridge handle Green On/Off button Blue i-button Orange Shock [...]
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E-3 PHILIPS MEDICAL SYSTEMS E DEFIBRILLATION W A V EFORM category specifications wa v eform parameters Biphasic truncated exponent ial. W a veform parameters are automatically adjusted as a function of patient defibril lation impedance . In the diagram at left, D is the duration of phase 1 and E is th e duration of phase 2 of the wa v eform, F is t[...]
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PHILIPS MEDICAL SYS TEMS E-4 energy* (pediatr ic doses indicated are based on CDC gr o wth charts for the 50th percentile w eights for boys.) Using Hear tStart Adult SMAR T Pads: 150 J nominal ( ± 15%) into a 50 ohm load. Using Hear tStar t Infant/Child SMAR T Pads: 50 J nominal ( ± 15%) into a 50 ohm load. Sample pediatr ic energy doses: age ene[...]
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E-5 PHILIPS MEDICAL SYSTEMS E ECG ANALYSIS SYSTEM categor y specifications function Evaluates impedance of adhesive pads for proper contact with the patient’ s skin, and evaluates the ECG rh ythm and signal quality to determine if a shock is app ropria te . shockable rh ythms V entricular fibr illation (VF) and some ventricular tach ycard ias ass[...]
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PHILIPS MEDICAL SYS TEMS E-6 ECG ANALYSIS PERF ORMANCE rh ythm class ECG test sample a size meets AHA recommendations b for adul t de fibri lla tio n obser ved 90% one-sided performance lower confidence limit shockable rh ythm — ventr icular fibrillation 300 sensitivity >90% (meets AAMI DF80 requir ement) (87%) shockable rh ythm — ventr icul[...]
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E-7 PHILIPS MEDICAL SYSTEMS E ACCESSORIES SPECIFICATIONS BATTER Y M507 0A HEAR TSTAR T ADULT SMART P ADS M5071A AND INFANT/CHILD SMAR T P ADS M5072A categor y specifications batter y 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 op erating time at 77° F[...]
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PHILIPS MEDICAL SYS TEMS E-8 ENVIRONMENTAL CONSIDERATIONS By complying with your national r egula tions r egarding d isposal of electric, electronic, and batter y waste , you can mak e a positive contribution to our shared envir onment. Such waste can introduce ha rmful elements into the en vir onment as a whole and ma y also endanger human health [...]
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PHILIPS MEDICAL SYSTEMS F-1 E F CONFI GUR ATION OVER VIEW The Philips HeartStar t OnSite Defibr illator comes wi th a factor y default configuration designed to meet the needs of mos t users. This configuration can only be changed by an authorized person using Hear tStart Configure software. This software is f or use by trained personnel. Informati[...]
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PHILIPS MEDICAL SYS TEMS F-2 PA TIENT TREATMENT PROTOCOL OPTIONS parameter settings default default de scription “call EMS” voice reminder timing • At power on (when the user turns on the OnSite) • At power on and at the star t of the first patient care pause • At the start of the first patient car e pause •N o r e m i n d e r At the st[...]
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F-3 PHILIPS MEDICAL SYSTEMS E protocol pause time r (minutes) 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 2.0 A 2-minute pr otocol pause for CPR automatically starts after voice instruction is given when a shock series is completed. After the pr otocol pause , the OnSite returns to rh ythm analysis. If the user presses the i-button for optional CPR coaching, the [...]
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PHILIPS MEDICAL SYS TEMS F-4 NSA pause timer (minutes) 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 pro vides coaching for 5 cycles of CPR, star ting and ending with compress[...]
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F-5 PHILIPS MEDICAL SYSTEMS E CPR Coaching adult v entil ation instruction Y es, No Y es Optional CPR Coaching includes rescue br eaths at the rate determined by the CPR Coaching compression:v entilation ratio for adults when an adult p ads cartridge is installed. NO TE: if this par ameter is configured to NO, CPR Coaching will always be compressio[...]
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PHILIPS MEDICAL SYS TEMS NOTES[...]
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PHILIPS MEDICAL SYSTEMS G-1 E G T ESTING AND TROUB LESHOOTING TE S T I N G As long as a batter y is installed, the Heart Start OnSite Defibrillator automatically tests itself every da y and aler ts you if it finds a pr oblem. The self -test includes pads readiness testing. In addition, it runs a pads self-tes t each time a pads car tridge is insert[...]
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PHILIPS MEDICAL SYS TEMS G-2 batter y is a vailable, remo v e the installed battery for fiv e seconds, then r einsert it and run a batter y inser tion self-test. If the problem contin ues, do not use the OnSite . Attend to t he patient, pr oviding CPR if needed, until Emergen cy Medical Ser vices Personnel arr ive. T ROUBLESHOOTING WHILE THE ONSITE[...]
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G-3 PHILIPS MEDICAL SYSTEMS E ... to stop all mot ion • The p atient is being mov ed or jostled. • T he envir onment is dry and movement ar ound the patient is causing static electr icity to interfer e with ECG analysis. • Radio or electrical sources ar e interfer ing with ECG analysis. • Stop CPR; do not touch the patient. Minimize patient[...]
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PHILIPS MEDICAL SYS TEMS G-4 T ROUBLESHOOTING WHILE THE ONSITE IS NOT IN USE (green Ready light is not on) beha vior possible cause recommended action chirps or i-button flashes • The batter y power is lo w or the SMAR T Pads cartri dge needs to be replaced. • The OnSite ma y ha ve been turned off without a pads car tridge installed, or the in [...]
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PHILIPS MEDICAL SYSTEMS H-1 E H ADDITIONAL TECHNICAL INF OR MATION REQUIRED FOR EUROPEAN CONFORMITY ELECTROMAGNETIC CONFORMITY Guidance and manufacturer’ s declaration: The Hear tStart OnSite Defibr illator is intended for use in the electr omagnetic en vir onment specified in t he tables belo w . The customer or user of the OnSite should assure [...]
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PHILIPS MEDICAL SYS TEMS H-2 ELECTROMAGNETIC IMMUNITY immunity test IEC 60601 test lev el compliance lev el electromagnetic envir o nment - guidance electr ostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air There ar e no special requirements with respect to electr ostatic disc ha rge . a power fr equency ([...]
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H-3 PHILIPS MEDICAL SYSTEMS E RECOMMENDED SEPARA TION DISTANCES BETWEEN POR TABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE ONSITE The OnSite is int ended for use in an electromagnetic environment in which radiated RF disturbances are contr olled. The customer or the user of the OnSite can help prev ent electromagnetic interference by maintain[...]
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PHILIPS MEDICAL SYS TEMS H-4 IMPOR TANT WAR NINGS AND REMINDER S • Do not allow the pads to contact other electrodes or metal parts that are in contact with the patient. • Before deliv ering a shock, it is impor tant to disconnect t he patient from other medical electrical equipment, such as b lood-flow meters, that may not incorporate defibril[...]
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PO WER T O SA VE A LIFE Philips Medical Systems is par t of Ro yal Philips Electronics Philips Medical Systems United States Philips Medical Systems 2301 Fifth A v enue, Suite 200 Seattle, W A, 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 Phil[...]