Philips Heartstart OnSite User manual

HeartStart OnSite Defibrillator

OWNER’S MANUAL Guide to Set-Up, Operation, Maintenance, and Accessories

M5066A

Edition 7

The HeartStart OnSite Defibrillator

ABCDE

JKL

top

front view

back view

Pads Cartridge Handle. Pull

the handle to turn on the HeartStart and remove the cartridge’s hard cover.

Ready Light. This green light

tells you the readiness of the HeartStart.

Blinking: standby mode

(ready for use) Solid: in use Off: needs attention

(HeartStart “chirps” and i-button flashes)

On/off Button. Press this

green button to turn on the HeartStart. To turn off the HeartStart, press the green button again and hold it down for one (1) second.

Information-Button. This

blue “i-button” flashes when it has information you can access by pressing it. It also flashes at the beginning of a patient care pause when CPR Coaching is enabled.

Caution Light. This triangular

light flashes during rhythm analysis and is on when a shock is advised, as a reminder that no one should be touching the patient.

Shock Button. When

instructed by the HeartStart to deliver a shock, press this flashing orange button .

Infrared (IR)

Communications Port.

special lens, or “eye,” is used to transfer HeartStart data directly to or from a computer.

This

Speaker. When the device is

being used, its voice instructions come from this speaker.

Beeper. The HeartStart

“chirps” through this beeper to alert you when it needs attention.

SMART Pads Cartridge. This

disposable cartridge contains selfadhesive pads with attached cable. Shown with adult pads cartridge.

SMART Pads Cartridge

Slide the latch to the right

Latch.

to release the pads cartridge for replacement.

Battery. The disposable

battery is inserted in a recess on the back of the HeartStart.

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HeartStart OnSite Defibrillator

QUICK REFERENCE

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Intentionally blank.

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HeartStart OnSite

M5066A Automated External Defibrillator

OWNER’S MANUAL

Edition 7

IMPORTANT NOTE:

It is important to understand that sur vival 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%.

Defibrillation 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

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. This information is subject to change. Please contact Philips at www.medical.philips.com/heartstart or

1.800.263.3342 for information on revisions.

Edition history

Edition 7 Publication date: January 2007 Publication #: M5066-91900 Assembly #: 011666-0007 Printed in the U.S.A.

No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or translated into any human or computer language in any form by any means without the consent of the copyright holder.

Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of Philips Medical Systems to provide accurate and up-to-date information to users and operators alike.

Authorized EU representative

Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Strasse 2 71034 Boeblingen, Germany (+49) 7031 463-2254

Caution

The Philips HeartStart OnSite Defibrillator is designed to be used only with Philips-approved accessories. The HeartStart may perform improperly if non-approved accessories are used.

Device tracking

In the U.S.A., this device is subject to tracking requirements by the manufacturer and distributors. If the defibrillator has been sold, donated, lost, stolen, exported, or destroyed, notify Philips Medical Systems or your distributor.

Device manufacturer

The HeartStart OnSite Defibrillator is manufactured by Philips Medical Systems, Seattle, Washington, USA.

Patents

This product is manufactured and sold under one or more of the following United States patents: US6047212, US6317635, US5892046, US5891049, US6356785, US5650750, US6553257, US5902249, US6287328, US6662056, US5617853, US5951598, US6272385, US6234816, US6346014, US6230054, US6299574, US5607454, US5803927, US5735879, US5749905, US5601612, US6441582, US5889388, US5773961, US6016059, US6075369, US5904707, US5868792, US5899926, US5879374, US5632280, US5800460, US6185458, US5611815, US6556864, US5607454, and other patents pending.

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HEARTSTART ONSITE M5066A

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CONTENTS

1 Introduction to the HeartStart OnSite

Description ........................................................................................................... 1-1

Sudden Cardiac Arrest ....................................................................................... 1-1

Indications for Use .............................................................................................. 1-2

Training and practice .......................................................................................... 1-2

State and local requirements ............................................................................ 1-2

For more information ......................................................................................... 1-3

2 Setting up the HeartStart OnSite

Package contents ................................................................................................. 2-1

Setting up the OnSite ......................................................................................... 2-1

Recommended accessories ............................................................................... 2-4

3 Using the HeartStart OnSite

Overview ............................................................................................................... 3-1

STEP 1: PULL the green handle ........................................................................ 3-2

STEP 2: PLACE the pads .................................................................................... 3-3

STEP 3: PRESS the Shock button ..................................................................... 3-4

Treating infants and children ............................................................................ 3-5

When emergency medical services arrive ..................................................... 3-6

4 After using the HeartStart OnSite

After each use ...................................................................................................... 4-1

OnSite data storage ............................................................................................ 4-2

5 Maintaining the HeartStart OnSite

Routine Maintenance .......................................................................................... 5-1

Periodic checks .................................................................................................... 5-1

Cleaning the OnSite ............................................................................................ 5-2

Disposing of the OnSite ..................................................................................... 5-2

Troubleshooting tips ........................................................................................... 5-2

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

G Testing and troubleshooting

H Additional technical information required for European conformity

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HEARTSTART ONSITE M5066A

1 Introduction to the HeartStart OnSite

Description

The Philips HeartStart OnSite Defibrillator M5066A (“OnSite”) is part of the Philips HeartStart HS1 family of defibrillators. Small, lightweight, and battery powered, it is designed for simple and reliable operation.

Sudden Cardiac Arrest

The OnSite is used to treat the most common causes of sudden cardiac arrest (SCA), including ventricular fibrillation (VF). SCA is a condition that occurs when the heart unexpectedly stops pumping. SCA can occur to anyone – infant, child, adult, male or female – anywhere, at any time. Many victims of SCA do not have warning

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signs or symptoms.

VF is a chaotic quivering of the heart muscle that prevents it from pumping blood. The only effective treatment for VF is defibrillation.The OnSite treats VF by sending a shock across the heart, so it can start beating regularly again. Unless this is successful within the first few minutes after the heart stops beating, the victim is not likely to survive.

1-1

1-2

Indications for Use

The OnSite should be used to treat someone you think may be a victim of SCA. A person in SCA:

• does not respond when shaken, and

• is not breathing normally.

If in doubt, apply the pads. Follow the voice instructions for each step in using the defibrillator.

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 on-line at www.medical.philips.com, for information about training programs in your area.

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HEARTSTART ONSITE M5066A

NOTE: Training accessories are available from Philips for practicing use of the OnSite. See Appendix A for information on ordering accessories.

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.

1-3

For more information

Contact your local Philips representative for additional information about the OnSite. They will be happy to answer any questions you may have and to provide you with copies of the clinical summaries of several key studies using Philips automated external defibrillators.

You can also find the clinical summaries online at www.medical. philips.com/heartstart. Technical information about all Philips HeartStart automated external defibrillators is also available online, in the Technical Reference Guide for HeartStart Defibrillators.

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* Clinical summaries also include Heartstream ForeRunner and FR2

Defibrillators.

Notes

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HEARTSTART ONSITE M5066A

2 Setting up the HeartStart OnSite

Package contents

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 Philips. See Appendix A for a

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description of these items.

Setting up the OnSite

Setting-up the OnSite is simple and quick.

1. Remove the OnSite from its packaging.

2. Remove a new SMART Pads Cartridge from its package.

* To replace a used cartridge or insert a

different cartridge, first locate the latch at the top edge of the OnSite, and slide it to the side. The pads cartridge will be released. Lift out the cartridge and replace as described in steps 2 and 3.

2-1

2-2

+ kg

55+

lbs

25+ kg

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.

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. Remove the battery from its packaging. Install it in the battery compartment on the back of the OnSite.

5. The OnSite will automatically run a self-test when the battery is inserted. Press the Shock button when instructed. When the self-test is over, the OnSite will report the result, and tell you to push the green On/Off button in case of an emergency. (Do not push the green button unless this is an actual emergency.) Then the OnSite will turn off and go to standby mode. The green Ready light will be blinking to show the OnSite is ready for use.

* As long as a battery is installed, turning the OnSite “off” puts it into standby

mode, which means that it is ready for use.

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HEARTSTART ONSITE M5066A

2-3

NOTE: Always store the OnSite with a pads cartridge and a battery installed, so it will be ready to use and can perform daily self-tests.

6. Place the OnSite in the carry case, pressing it firmly into place. Insert the Quick Reference Guide, window on the inside of the case.

face up, in the clear plastic

†

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.

7. Store the OnSite in accordance with your site’s emergency response protocol. Typically, this will be in a high-traffic area that is easy to access, convenient for checking the Ready light periodically, and easy to hear the alarm chirp if the battery power gets low or the OnSite needs attention. Ideally, the

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OnSite should be stored near a telephone, so the Emergency Response Team or Emergency Medical Services can be alerted as fast as possible in the event of a possible SCA. If possible, keep the spare SMART Pads Cartridge and other accessories with the defibrillator - in the carry case if one is used - for quick access when needed. In general, treat the OnSite as you would any piece of electronic equipment, such as a computer. Be sure to store the OnSite according to its specifications. See Appendix E

* The illustration on the cover of the Quick Reference Guide is a 3-step guide to

using the HeartStart. Detailed illustrated directions are inside, for reference in an emergency, or if you are hearing impaired or using the HeartStart where it is hard to hear the voice instructions.

† If you do not have a carry case, put the Quick Reference Guide in the separate

clear plastic sleeve. Press the hook-and-loop strip on the sleeve onto the strip on the back of the OnSite. Make sure the “Call 911” sticker is easy to see if someone needs to use the OnSite in an emergency. If your Emergency Medical Services number is not 911, use the blank sticker with the telephone symbol to write the correct number. Then put the sticker over the “Call 911” sticker on the front of the sleeve.

2-4

for details. As long as a battery and a pads cartridge are installed, the green Ready light should be blinking to show that the HeartStart has passed its most recent self-test and is therefore ready to use.

NOTE: If you have a training pads cartridge, it is recommended that you store it separately from the OnSite, so the training pads cannot be confused with the regular pads in an emergency.

Recommended accessories

It is always a good idea to have a spare battery and a spare pads set. Other things that are useful to keep with the OnSite include:

• scissors — for cutting the victim’s clothes if needed

• disposable gloves — to protect the user

• a disposable razor — to shave the chest if hair prevents good pads 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

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HEARTSTART ONSITE M5066A

Philips has a Fast Response Kit with all these items. See Appendix A for details.

If you may need to defibrillate an infant or a child under 55 pounds (25 kg) or 8 years old, it is recommended that you order the Infant/Child SMART Pads Cartridge, available separately by prescription. When the Infant/Child Pads Cartridge is installed in the OnSite, the OnSite automatically reduces the defibrillation energy to an energy level more appropriate for infants and children. In addition, if optional CPR Coaching is selected, the OnSite provides coaching appropriate for infants and children when the Infant/Child SMART Pads Cartridge is installed. Directions for using the Infant/Child SMART Pads Cartridge are provided in Chapter 3, “Using the HeartStart OnSite.”

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

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.

• Quickly get the OnSite and bring it to the victim’s side. If there is any delay in getting the OnSite, check the patient and perform cardiopulmonary resuscitation (CPR) if needed until the OnSite is available.

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• If the patient is an infant or child, first perform CPR, then call for emergency medical services (EMS) before you apply the OnSite. See special section on treating infants and children on page 3-5.

• Check the immediate environment for flammable gases. Do not use the OnSite in the presence of flammable gases, such as an oxygen tent. However, it is safe to use the OnSite on someone wearing an oxygen mask.

There are three basic steps to using the OnSite to treat someone who may be in sudden cardiac arrest:

1. PULL up the handle on the SMART Pads Cartridge.

2. PLACE the pads on the patient’s bare skin.

3. PRESS the flashing Shock button if instructed.

The following pages provide details about each step.

3-1

3-2

55+

25+

STEP 1: PULL the green handle

Turn on the HeartStart by pulling the SMART Pads Cartridge’s green

handle. aside. Remain calm and follow the HeartStart’s instructions.

Remove the hard cover from the pads cartridge and set it

The OnSite starts by directing you to remove all clothes from the patient’s chest. If necessary, rip or cut off the clothing to bare the person’s chest.

* You can also turn on the OnSite by pressing the green On/Off button.

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HEARTSTART ONSITE M5066A

3-3

Where to place pads on adults and children over

55 pounds or 8 years old (anterior-anterior).

Where to place pads on infants or

children under 55 pounds or 8

years old (anterior-posterior).

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. 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.

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3-4

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. When you press the Shock button, the OnSite tells you that the shock has been delivered. Then the defibrillator tells you it is safe to touch the patient, instructs you to begin CPR, and invites you to press the flashing blue i-button for CPR Coaching if desired.

If a shock is not needed:

The OnSite tells you it is safe to touch the patient and instructs you to perform CPR if needed. (If CPR is not needed - for example, if the patient is moving or regaining consciousness - follow your local protocol until emergency medical personnel arrive.) The blue i-button will start flashing during this patient care pause. Press it in the first 30 seconds of this patient care pause for CPR Coaching if desired.

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HEARTSTART ONSITE M5066A

For CPR Coaching:

Press the flashing blue i-button during the first 30 seconds of the

patient care pause to activate CPR Coaching.

(If the Infant/Child

SMART Pads Cartridge is inserted, CPR Coaching will provide

* 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 by prescription. See Appendix F for more information.

3-5

coaching for infant/child CPR.) When the pause is over, the OnSite tells you to stop CPR, so it can analyze the patient’s heart rhythm. The motion caused by CPR can interfere with analysis, so be sure to stop all motion when instructed.

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.

Alternatively, follow your local protocol.

If the patient is under 55 pounds or 8 years old and you have an Infant/

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Child Pads Cartridge:

• Remove the Infant/Child Pads Cartridge from its package.

• Locate the latch at the top edge of the OnSite, and slide it to the side. The pads cartridge will be released. Remove the old cartridge.

• Install the new cartridge: slide the bottom end of the cartridge into the recess, then press in the cartridge until the latch clicks into place. Be sure the green handle is pressed down firmly. The HeartStart will tell you that Infant/Child pads have been inserted, then it will turn off to be ready for use.

• Pull the green handle to start the rescue.

* Philips recommends that the HeartStart be stored with an adult pads cartridge

installed, as pediatric cardiac arrest is not common.

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