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45

DEVICE SAFETY AND PERFORMANCE SUMMARY

Clinical summaries of several key studies 
using Philips automated external 
defibrillators is in the HeartStart Home 
Defibrillator Instructions for Use available 
online at www.philips.com/AEDsupport.

 

HS1_Home_OM_English.book  Page 45  Thursday, June 13, 2019  1:18 PM

Содержание HeartStart Home

Страница 1: ...HeartStart Home Owner s Manual Your guide to set up operation maintenance and accessories IN AN EMERGENCY CALL EMS FIRST HS1_Home_OM_English book Page 1 Thursday June 13 2019 1 18 PM ...

Страница 2: ...le Ready light On Off button Information button i button Caution light Shock button Pads cartridge compartment shown here with cartridge installed Cartridge latch Battery front HS1_Home_OM_English book Page 2 Thursday June 13 2019 1 18 PM ...

Страница 3: ...victims are defibrillated For every minute of delay the chance of survival drops by about 10 However it is important to understand that defibrillation cannot always assure survival In some cases the cause of the cardiac arrest simply cannot be survived no matter how quickly the victim is treated HS1_Home_OM_English book Page i Thursday June 13 2019 1 18 PM ...

Страница 4: ...ON HISTORY Edition 11 Publication date June 2019 Publication number 453564883351 LANGUAGES Please contact Philips at 1 866 333 4246 with questions about the HeartStart Defibrillator in other languages NOTICES 2019 Koninklijke Philips N V All rights reserved Specifications are subject to change without notice Trademarks are the property of Koninklijke Philips N V or their respective owners HS1_Home...

Страница 5: ...aining the HeartStart 20 When to replace the battery 22 When to replace the pads 23 How to clean it 24 How to check that it s ready for use 20 What to do when it chirps 20 How to have it repaired 25 Common Questions 26 Is it safe for the user and bystanders 26 Can I use it on an infant or child 27 Can I use it on wet or metal surfaces 28 Can I travel with it 28 What if I donate the HeartStart Home...

Страница 6: ...on ________________________ Customer Support _________________________ SMART Pads Cartridge installed on ___________________________________ expiration date ________________________________ installed on ___________________________________ expiration date ________________________________ HeartStart Battery installed on ___________________________________ expiration date ____________________________...

Страница 7: ...doctor A defibrillator is not a replacement for seeking medical care SUDDEN CARDIAC ARREST Sudden cardiac arrest SCA occurs when the heart unexpectedly stops pumping blood through the body This is usually caused by a disorganized heartbeat called VF for ventricular fibrillation Many victims of SCA do not have warning signs or symptoms Some people may have a higher risk for SCA than others Causes v...

Страница 8: ... heart attack can lead to SCA If you feel the signs of a heart attack such as pain pressure or a squeezing feeling in your chest or anywhere in your upper body shortness of breath and stomach upset you should call Emergency Medical Services EMS right away and also call your doctor For people with certain medical conditions who are likely to suffer SCA an implantable cardioverter defibrillator ICD ...

Страница 9: ...5 pounds 25 kg or 8 years old when used with the optional Infant Child SMART pads Model M5072A If Infant Child SMART pads are not available or you are uncertain of the child s age or weight proceed with treatment using adult SMART pads Model M5071A CONTRAINDICATIONS The HeartStart Home Defibrillator should not be used when a patient is conscious or breathing normally TRAINING AND PRACTICE The Hear...

Страница 10: ...tart cannot be used by the victim of SCA another person must use it to treat the victim It is important to review these materials periodically They are intended to help make sure that in an emergency you will be able to use the HeartStart quickly and confidently In addition you can buy reusable supplies from Philips for practicing how to use your HeartStart See Ordering Accessories for ordering in...

Страница 11: ...our area contact us by phone at 1 866 DEFIBHOME 1 866 333 4246 or online at www philips com AEDSupport STATE AND LOCAL REQUIREMENTS Check with your state health department to see if there are any local or state requirements about owning and using a defibrillator You can find contact information for learning about your state s requirements online at www philips com AEDSupport HS1_Home_OM_English bo...

Страница 12: ...rtStart Home Defibrillator box Take the HeartStart out of its red case NOTE Leave the pads cartridge installed To avoid drying out the adhesive pads do not open the cartridge until you need to use the pads in an emergency Pull out the red tab to start the automatic battery self test 1 2 3 HS1_Home_OM_English book Page 6 Thursday June 13 2019 1 18 PM ...

Страница 13: ...at the bottom and remove the wrapping Then reinstall the defibrillator in its carry case If there was no voice during the self test if the HeartStart tells you the Shock button was not verified when you pressed it or if the green Ready light is not blinking at the end of the test call 1 866 DEFIBHOME 1 866 333 4246 for customer service NOTE Leave the battery installed The HeartStart runs a self te...

Страница 14: ...uick Reference Guide face up in the clear plastic window inside the carry case This Owner s Manual is also designed to be stored in the case in the pocket behind the Quick Reference Guide window Write your address on the Call 911 card on the back of the carry case If 911 is not your local EMS number use the back of the card and write in your EMS number A smaller Call 911 card is on the front of th...

Страница 15: ...an easily check that its green Ready light is blinking and hear it chirping if a self test reveals a problem It should be somewhere the temperature stays between 50 F and 109 F It will work at temperatures between 32 to 122 F Be sure everyone who may use it knows where the HeartStart is kept Help us stay in touch with you Fill out the HeartStart Support Program enrollment card in the box or call u...

Страница 16: ...s contact a pocket mask or face shield to protect the user a towel or absorbent wipes to dry the victim s skin for good pads contact Philips has a Fast Response Kit with all these items You can buy special Infant Child SMART Pads for use on children less than 8 years or less than 55 pounds Practice Kits with reusable adult or training pads and pad placement guides are also available See Ordering A...

Страница 17: ...houlder and shout Are you OK Someone who is just sleeping will respond Someone who is not responsive but not in sudden cardiac arrest will be breathing normally To check for breathing put your ear near the person s mouth and look at the chest to see if it rises and falls Infants and children more often become unresponsive due to breathing or other issues than to heart problems See page 27 for dire...

Страница 18: ...ay be in SCA act calmly and quickly Time is critical Call Emergency Medical Services usually 911 immediately or if possible have someone else call while you use the HeartStart Clearly tell the emergency operator This is give your name and location Someone here has collapsed I have a HeartStart Home Defibrillator Please send help immediately Quickly get the defibrillator Put it on the same side of ...

Страница 19: ... HeartStart s voice instructions Quickly remove clothing from the person s chest If necessary cut off the clothing with the scissors If the victim is an infant or young child remove all clothing from the upper body to bare both the chest and the back 55 lb s 25 kg HS1_Home_OM_English book Page 13 Thursday June 13 2019 1 18 PM ...

Страница 20: ...ient remove any medicine patches from the person s chest any headphones and other electrical devices with a wire or a cable It is okay to use the HeartStart on someone who has an implanted device such as a pacemaker or ICD but do not place the pads directly over the implant You can tell where an implant is located by a lump in the skin and a scar It is safe to use the HeartStart on someone wearing...

Страница 21: ...t the skin firmly Then peel and place the other pad as shown in its picture Where to place pads on adults and children 8 years old or 55 pounds or more Where to place pads on children less than 8 years old or 55 pounds One on ribs wrapping around side One on upper chest by collarbone One on chest one on back HS1_Home_OM_English book Page 15 Thursday June 13 2019 1 18 PM ...

Страница 22: ...lyze the patient s heart rhythm It tells you that no one should be touching the patient and the Caution light starts flashing If a shock is needed the HeartStart tells you to press the flashing orange button When you press the Shock button the HeartStart gives a shock It tells you the shock has been delivered then pauses so you can perform CPR if needed The HeartStart then analyzes the heart rhyth...

Страница 23: ...ED If the person is breathing you do not need to do CPR If the person is not breathing you should perform CPR The HeartStart tells you to press the i button for coaching on how to perform CPR NOTE For CPR coaching you must press the i button while it is flashing WHAT TO DO NEXT Leave the HeartStart turned on Leave the pads on Follow the HeartStart s instructions and tend to the patient until EMS a...

Страница 24: ... patient Explain as clearly as you can what has happened Then tell them that if they hold down the i button until it beeps the HeartStart Home Defibrillator will report how many shocks it gave and how long ago it was turned on More detailed information can be transferred from the HeartStart s memory to a computer running special software After care is transferred to EMS turn off the HeartStart pre...

Страница 25: ...to contact us by phone at 1 866 DEFIBHOME 1 866 333 4246 or email at www HeartStartHome com You will be helping us learn more about sudden cardiac arrest We are here to answer any questions you may have about the experience Also please let us know if you ever have any problems using or maintaining your HeartStart Home Defibrillator HS1_Home_OM_English book Page 19 Thursday June 13 2019 1 18 PM ...

Страница 26: ...y light is blinking you can be confident that the defibrillator has passed its latest self test and is ready for use WHAT TO DOWHEN IT CHIRPS Your HeartStart tests itself daily weekly and monthly so you can be sure it is ready to use in an emergency Any time the HeartStart chirps it is telling you something is wrong The green Ready light will be off which means you need to take action so that the ...

Страница 27: ...g serious is wrong with your AED It may not be ready to use in an emergency so it s important that you call technical support As long as you re not in an emergency call Philips for technical support right away at 1 866 333 4246 if you hear triple chirps If you re in an emergency and you hear triple chirps try to use the device You can take out the battery and put it back in which will sometimes al...

Страница 28: ... normally lasts for about four years in standby mode Standby mode means the HeartStart is ready for use with the battery installed and the green Ready light blinking When the HeartStart is turned on for use a new battery normally lasts for 4 hours or can give up to 200 shocks After you put the battery in the HeartStart the self test checks it every day When battery power gets low the HeartStart wi...

Страница 29: ... an unopened undamaged cartridge Each cartridge has an expiration date printed on the film seal and the package The HeartStart checks the pads every day as part of its self test If for any reason the pads are no longer good the HeartStart will start chirping and the green Ready light will turn off The pads are designed for only one use Replace the pads when they expire or are used To replace used ...

Страница 30: ...Setting Up the HeartStart for directions on how to put in a new cartridge See Ordering Accessories for ordering information HOW TO CLEAN IT You can clean the outside of the HeartStart and its red carry case with a soft cloth dampened with soapy water chlorine bleach 2 Tbsp quart or liter of water ammonia based cleaners HS1_Home_OM_English book Page 24 Thursday June 13 2019 1 18 PM ...

Страница 31: ...VE IT REPAIRED The HeartStart is not designed for repair by the user Do not open the HeartStart remove its covers or try to repair it You could be injured by dangerous high voltages and currents If the HeartStart is damaged please call 1 866 DEFIBHOME 1 866 333 4246 for service HS1_Home_OM_English book Page 25 Thursday June 13 2019 1 18 PM ...

Страница 32: ... or a bystander as long as the HeartStart is used according to directions and no one is touching the patient when the Shock button is pressed The HeartStart cannot deliver a shock unless it is used on someone whose heart needs a shock Even if you press the orange Shock button the HeartStart will not deliver a shock unless the defibrillator tells you to push it HS1_Home_OM_English book Page 26 Thur...

Страница 33: ...eigh 55 pounds or more use the adult pads that come with the HeartStart WARNING If you are not sure about the child s exact age or weight or if infant child pads are not available DO NOT DELAYTREATMENT Use the adult pads but place them on the child s chest and back as shown on page 14 With the adult pads on a child the optional CPR coaching will be for an adult To treat an infant or child Perform ...

Страница 34: ...l stick well to the skin Can I travel with it Yes The HeartStart is designed to be easily portable Just remember that if you take it along when you travel you should keep it where it can stay within its temperature range see page 8 When you get back put the HeartStart in its normal place so everyone will know where to find it in an emergency There may be rules against taking a defibrillator into s...

Страница 35: ...tStartHome com to find additional training resources HeartStart defibrillators that are used by an organization or in a facility that is not a home require different considerations These may include additional training a review of the organization s medical emergency response policies a site review to ensure proper placement and medical oversight among other things If this device will be given or ...

Страница 36: ... cartridge and pads placement guide M5090A adult pads placement guide M5075A standard carry case for extra storage room M5076A slim carry case comes with the HeartStart Home 68 PCHAT Fast Response Kit pouch with a pair of scissors 2 pairs of disposable gloves a disposable razor a pocket mask and an absorbent wipe Call 1 866 DEFIBHOME 1 866 333 4246 or visit www philips com AEDSupport to order Avai...

Страница 37: ...866 333 4246 We will be happy to answer your questions and to provide you with more information You can find detailed Instructions for Use for the HeartStart Home Defibrillator online at www philips com AEDSupport Clinical summaries of research studies about the technology used in the HeartStart are also available online HS1_Home_OM_English book Page 31 Thursday June 13 2019 1 18 PM ...

Страница 38: ...personal injury or death to the user and or the victim WARNING Conditions hazards or unsafe practices that can result in serious personal injury or death CAUTION Conditions hazards or unsafe practices that can result in minor personal injury damage to the HeartStart or loss of data stored in the device NOTE The HeartStart Home Defibrillator is designed to be used only with Philips approved accesso...

Страница 39: ...s safe to use the HeartStart on someone wearing an oxygen mask battery The HeartStart M5070A battery is not rechargeable Do not try to recharge open crush or burn the battery or it may explode or catch fire WARNINGS battery Removing and reinserting the battery one or more times when the HeartStart emits a series of triple chirps may reset the device and cause it to report it is ready for use 1 HS1...

Страница 40: ...HeartStart from service and contact Philips immediately fluids Do not let fluids get into the HeartStart Avoid spilling any fluids on the HeartStart or its accessories Spilling fluids into the HeartStart may damage it or cause a fire or shock hazard Do not sterilize the HeartStart or its accessories accessories Using damaged or expired equipment or accessories may cause the HeartStart to perform i...

Страница 41: ...tStart time to reconfirm the analysis before telling you to press the Shock button cell phones The HeartStart can work correctly when it is fairly close to equipment like emergency two way radios and cell phones Normally using a cell phone near the patient should not cause a problem for the HeartStart However it is best to keep such equipment only as close as necessary to the patient and the Heart...

Страница 42: ... to cardiac arrest in an infant or child Provide infant child CPR while a bystander calls EMS and retrieves the HeartStart If no bystander is available provide 1 2 minutes of CPR before calling EMS and retrieving the HeartStart If you witnessed the child s collapse call EMS immediately and then get the HeartStart Alternatively follow your local protocol PHILIPS MEDIC AL SYSTEMS HS1_Home_OM_English...

Страница 43: ...irections Avoid directly handling the HeartStart or its accessories if they have been in contact with body fluids from the patient Such substances could contain infectious material causing the spread of harmful diseases Refer to this manual s section on cleaning the HeartStart after a use if necessary maintenance Improper maintenance may damage the HeartStart or cause it to function improperly Mai...

Страница 44: ...ets make sure pads stick well to the skin Do not use dried out pads because they will not provide good contact with the skin shock hazard The HeartStart is not protected from electrical shock hazard if it is opened The HeartStart is protected from electrical shock hazard while it is intact Do not open the HeartStart remove its covers or attempt to repair it There are no user serviceable components...

Страница 45: ...mpacted by emissions from the HeartStart If this occurs move the impacted equipment away from the HeartStart until the HeartStart is no longer needed for the patient or EMS arrives and takes over the scene environmental conditions Using the HeartStart outside of the specified environmental range temperature humidity atmospheric pressure may result in incorrect or intermittent operation Make sure t...

Страница 46: ...art is set to a language that the majority of the users of that HeartStart may be familiar with pacemakers Do not place the pads directly over an implanted pacemaker or defibrillator A noticeable lump with a surgical scar should indicate the position of an implanted device pads If the pads do not stick well to the skin check that the pads adhesive has not dried out Each pad has a layer of adhesive...

Страница 47: ...onds after the instruction the HeartStart will disarm itself and for the first CPR interval give a reminder to make sure emergency medical services have been called The HeartStart will then begin a CPR interval This is designed to minimize interruption of CPR and help ensure ongoing patient support If for any reason you want to turn off the defibrillator during a use you can press the On Off butto...

Страница 48: ...s uses battery power and risks draining the battery prematurely cpr Even when CPR is applied correctly the patient s chest may become bruised or ribs may be fractured Performing CPR incorrectly could cause additional injuries to a patient or may not provide needed benefit to the patient Be sure to follow the CPR Coaching instructions provided by the HeartStart Be sure to turn on CPR coaching if yo...

Страница 49: ...ent If the artifact continues for more than 30 seconds the HeartStart will pause briefly to allow you to deal with the source of the noise then resume analysis PROBABLE ADVERSE EFFECTS OFTHE DEVICE ON HEALTH Following are the probable adverse effects of the device on health Failure to identify shockable arrhythmia Failure to deliver a defibrillation shock in the presence of ventricular fibrillatio...

Страница 50: ...ectly shocking a pulse sustaining rhythm and inducing VF or cardiac arrest Bystander shock from patient contact during defibrillation shock Interaction with pacemakers Skin burns around the defibrillation pads placement area Allergic dermatitis due to sensitivity to the materials used in the defibrillation pads construction Minor skin rash HS1_Home_OM_English book Page 44 Thursday June 13 2019 1 1...

Страница 51: ...summaries of several key studies using Philips automated external defibrillators is in the HeartStart Home Defibrillator Instructions for Use available online at www philips com AEDsupport HS1_Home_OM_English book Page 45 Thursday June 13 2019 1 18 PM ...

Страница 52: ...et troubleshooting information At any time you can press and hold the i button for at least two seconds to get summary information about defibrillator s last use and condition On Off button A green button on the front of the HeartStart Home Defibrillator Press the On Off button to turn the defibrillator on or off disarm the HeartStart or stop the self test that runs when a battery is put in Ready ...

Страница 53: ...m and to transfer the shock if needed Standby mode The status of the HeartStart when the battery is in place and the HeartStart is ready for use when needed A blinking green Ready light means the HeartStart is in standby mode SCA Sudden cardiac arrest The sudden stopping of the heart s ability to pump blood A person in SCA does not respond when shaken and is not breathing normally Ventricular fibr...

Страница 54: ...amily Accessories Philips will replace or repair accessories for the HeartStart HS1 family of defibrillators within the specified warranty period if they are found to be defective in materials or workmanship or if they do not meet the specifications published by Philips The HS1 battery is warranted for four years from the date of installation The SMART Pads cartridge is warranted until the expirat...

Страница 55: ...e shall be limited to the duration of the express warranties set forth in this limited warranty Some states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you Limitation of Remedies In no event shall Philips be liable for any special incidental or consequential damages based upon breach of warranty breach of contract negligence tort or any o...

Страница 56: ...position 15 pads replacement 23 pressing the Shock button 16 R repairing the HeartStart 25 S safety 26 32 set up 6 standby mode 22 37 storing the HeartStart 9 sudden cardiac arrest SCA 1 37 symptoms of SCA 11 T training 4 traveling with the HeartStart 28 turning off the HeartStart 18 turning on the HeartStart 13 HS1_Home_OM_English book Page 0 Thursday June 13 2019 1 18 PM ...

Страница 57: ...NOTES HS1_Home_OM_English book Page 1 Thursday June 13 2019 1 18 PM ...

Страница 58: ...Intentionally blank HS1_Home_OM_English book Page 1 Thursday June 13 2019 1 18 PM ...

Страница 59: ...tuation that called for using the HeartStart Home Defibrillator we urge you to contact us by phone at 1 866 DEFIBHOME 1 866 333 4246 or email at www HeartStartHome com to discuss the experience HS1_Home_OM_English book Page 2 Thursday June 13 2019 1 18 PM ...

Страница 60: ...Philips Medical Systems 22100 Bothell Everett Highway Bothell WA 98021 8431 USA 453564883351 453564883351 HS1_Home_OM_English book Page 3 Thursday June 13 2019 1 18 PM ...

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