Heartsine Samaritan pad 300 User manual

Samaritan® PAD

USER INSTRUCTIONS

For using

Model SAM 300

With Software Version complaint with AHA/ERC Guidelines

2000 and 2005

2006 VERSION H017-001-006-2

2 © Heartsine Technologies

Manufactured by:

HeartSine Technologies Inc HeartSine Technologies Ltd

(Worldwide Headquarters) (European Operations)

105 Terry Drive Canberra House

Newtown, PA 18940 203 Airport Road West

Belfast, BT3 9ED, Northern Ireland

Telephone:

+1-215-860-8100

Telephone:

+44 28 9093 9400

Fax:

+1-215-860-8192

Fax:

+44 28 9093 9401

Website:

www.HeartSine.com

E-Mail:

support@HeartSine.com

Information in this document is subject to change without notice and does not represent a commitment on behalf

of HeartSine Technologies. No part of this manual may be reproduced or transmitted in any form or by any

means, electrical or mechanical, including photocopying and recording for any purpose without the express

written permission of HeartSine Technologies.

“samaritan” is a registered trademark of HeartSine Technologies.

“Saver”, and “SCOPE” are trademarks of HeartSine Technologies.

All other trademarks and registered trademarks are the property of their respective owners.

PAD User Manual

AVAILABLE PAD CONFIGURATIONS

AHA/ERC 2000 or AHA/ERC 2005

3 Shocks

1 Shock

60 sec CPR Pause

120 sec CPR Pause

150J – 150J – 200J

HeartSine Technologies provides you with a fully configureable samaritan PAD system to

allow you to comply with your chosen SCA treatment protocol. Our current devices can

be configured to be compliant with the 2000 or 2005 version of the AHA/ERC guidelines

on Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC).

You should have been trained in the appropriate version of the AHA/ERC guidelines and

the use of your device configuration. Please refer to page 12 of this manual for

identification of your device’s configuration. Contact your authorised HeartSine distributor

for further information.

ICONS USED IN THIS MANUAL



NOTE

WARNING



VOICE PROMPT



TO DO or CHECKS

4 © Heartsine Technologies

Content

1 INTRODUCTION, REGULATORY REQUIREMENTS..................................6

2 WARNINGS ..............................................................................................7-8

3 OVERVIEW OF THE SAMARITAN® PAD ..................................................9

3.1 Indications for Use.............................................................................................9

3.2 The samaritan® PAD Controls......................................................................9-10

3.3 Samaritan® PAD symbols ..........................................................................11-12

4 PREPARING THE SAMARITAN

PAD FOR USE .....................................13

4.1

Quick List.........................................................................................................13

4.2

Understanding and installing the Pad-Pak™...............................................13-14

4.3

Ensuring the samaritan

PAD is working correctly...........................................14

4.4

Where to place the samaritan

PAD................................................................15

5 PREPARING THE PATIENT ......................................................................16

5.1

Patient Checklist..............................................................................................16

5.2

Placing Pads on the Patient........................................................................16-17

6 USING THE SAMARITAN® PAD............................................................... 18

6.1 Quick Start.......................................................................................................18

6.2 Useful Hints.....................................................................................................18

6.3 Step-by-Step Instructions............................................................................19-22

6.4 Understanding Check Patient Mode.................................................................23

6.5 Post Use Procedure....................................................................................23-24

7 UNDERSTANDING THE SAMARITAN® PAD........................................... 25

7.1

What is the samaritan

PAD?..........................................................................25

7.2

What does the samaritan

PAD do?................................................................25

7.3

What is heart rhythm?......................................................................................26

7.4

How does the samaritan

PAD work? .............................................................26

7.5 What is biphasic? ............................................................................................27

7.6

Escalating energy protocol...............................................................................28

7.7

Biphasic waveform specifications.....................................................................28

7.8

How is impedance measured?.........................................................................29

PAD User Manual

8 UNDERSTANDING THE SAMARITAN

PAD INTERFACE....................... 30

8.1

Understanding visual indicators.......................................................................30

8.2

Status Indicator................................................................................................30

8.3

Defibrillation Pads Connection Indicator...........................................................31

8.4

Shock Button Indicator.....................................................................................31

8.5

Rescuer Action Indicators ...............................................................................32

8.6

Audible prompting............................................................................................33

8.7

Audible indications...........................................................................................33

8.8

Voice prompting...............................................................................................33

9 RECORDING THE SAMARITAN

PAD’S USAGE..................................... 34

9.1

Recorded ECG information..............................................................................34

9.2

Events log...................................................................................................34-35

9.3

Other information recorded..............................................................................35

10 MAINTAINING THE SAMARITAN

PAD.................................................... 36

10.1

Checking after each use.............................................................................36-37

10.2

Monthly checks to perform...............................................................................37

10.3

Cleaning the device.........................................................................................37

10.4

Storing the device............................................................................................38

10.5

Battery specifications.......................................................................................38

11 SELECTED ACCESSORIES FOR THE SAMARITAN® PAD....................39

12 TROUBLESHOOTING................................................................................40

13 WARRANTY AND REPAIR...................................................................40-41

APPENDIX..................................................................................................42

i Samaritan

PAD technical specification .....................................................43-45

ii SCOPE™ Biphasic waveform specification.....................................................46

iii ECG analysis detection system description......................................................47

iv ECG arrhythmia analysis algorithm performance.............................................48

v SCOPE™ Biphasic Clinical Summary.............................................................49

Glossary…………………...........................................................................................51

6 © Heartsine Technologies

1. INTRODUCTION

This manual explains how you use the samaritan® PAD

PAD stands for Public Access Defibrillator. The samaritan® PAD is a semi-automatic

device used for the delivery of external defibrillation therapy to resuscitate victims of

sudden cardiac arrest (SCA), who are unresponsive to stimulus, are not breathing, or

have no detectable pulse. The samaritan® PAD is designed for infrequent use. The

samaritan® PAD can also be used in conjunction with the Saverdata management

system. Saverdata management software and USB communication cable is used to

configure and to review the use of the samaritan® PAD. Information about Saverdata

management software is provided in the separate Saveruser manual.



Consult your local laws for the legal requirements covering the use and sale of

Automated External Defibrillators. United States Federal Law restricts the use

of this device by or on the order of a physician.

REGULATORY REQUIREMENTS

Defibrillator Tracking Requirements:

The U.S. Federal Regulations (21 CFR 821) requires that manufacturers of defibrillators

track the location of each defibrillator it manufactures. This regulation further requires

that each purchaser or owner of a defibrillator notify the manufacture if the product is lost,

stolen or destroyed. If the defibrillator changes ownership (either by donation, reselling

or distribution) the manufacturer must be notified of the new location.

Notification of Adverse Events Requirements:

The Safe Medical Device Act requires that the defibrillator manufacturer and the FDA be

notified of specific adverse events. These reporting events pertain to device related

death, serious injury or illness. Who is required to report and what events are considered

a reportable event can be found in the U.S. Federal Regulations, 21 CFR 803. If you are

unsure of what to do, always report any samaritan® malfunctions or failures to HeartSine

Technologies.



The requirement to report these events in the EU (incident reporting) and

Canada (mandatory problem reporting) is covered in the medical device

directive 93/42/EEC and the Canadian medical devices regulations.

PAD User Manual

2. WARNINGS

This section provide you with important warnings while using the PAD.

The samaritan® PAD has the capability to deliver therapeutic electrical

shocks. The electrical shock can cause serious harm to either operators

or bystanders. Caution must be taken to ensure that neither the operators

or bystanders touch the patient when a shock is to be delivered.

The samaritan® PAD has been designed to work on unconscious/non-

responding patients. Movement of the patient during analysis of heart

rhythm can cause an error or delay in diagnosis. Care must be taken to

minimise movement of the patient while analysis of their heart rhythm is

being carried out.

Touching the patient during the analysis phase of treatment can cause

interference with the diagnostic process. Avoid physical contact with the

patient until analysis and/or treatment has been completed unless the

device instructs the operator to perform CPR.

It has been determined that the samaritan® PAD is safe to use in

conjunction with oxygen mask delivery systems. However, due to the

danger of explosion it is strongly advised that the samaritan® PAD should

not be used in the vicinity of explosive gases. This includes flammable

anaesthetics or concentrated oxygen.

8 © Heartsine Technologies

The PAD-Pak™ is to be used only on patients greater than 8 years old (≥

55lbs / 25kg in weight). For patients under 8 years old ( <55lbs / 25kg in

weight) the HeartSine PAED-Pak™* (Paediatric electrode and battery

cartridge) must be used.

Periodic checks (as defined in this manual) of this device must be under-

taken to ensure among other things that the samaritan® PAD is not

damaged in any way.

Proper placement of the samaritan® PAD pads is critical. Strict

observance of pad positioning instructions, as indicated on the labelling

and in training, is essential. Care must be taken to ensure pads are

adhered to the patients’ skin properly. Air pockets between the adhesive

pad and skin must be eliminated. Failure in pad adhesion may hinder

effectiveness of therapy or cause excessive skin burns to the patient if a

therapeutic shock is applied. Reddening of the skin may appear after use,

this is normal.

Both the Pad-Pak™ and Ped-Pak™ are single use items and must be

replaced if their pouch seal has been broken or compromised in any way.

If damage is suspected the Pad-Pak™ or Ped-Pak™ must be replaced

immediately.

* Not available this user manual was written. Ask HeartSine or your authorised distributor for more

details.

This device is to be used by a person trained in the use of the product.

PAD User Manual

3. OVERVIEW OF THE SAMARITAN® PAD

This section provides you with essential information that you can use to prepare yourself

for using the samaritan® PAD and as reference information for use while you use the

device. This section contains chapters such as preparing the patient and provides

instructions on how to use the device to deliver therapy:

3.1 Indications for Use

3.2 The samaritan® PAD Controls

3.3 Samaritan® PAD Symbols

3.1 Indications for Use:

The HeartSine samaritan® PAD is indicated for use on victims of cardiac arrest who are

exhibiting the following signs:



Unconscious



Not Breathing



Without Circulation

The samaritan® PAD is intended for use by personnel who have been trained in its oper-

ation. Users should have received training in basic life support / CPR-D, advanced life

support or a physician-authorized emergency medical response training program. The

samaritan® PAD is not currently indicated for use on children less than 8 years old (≥

55lbs/25kg in weight).

3.2 The samaritan

PAD controls

This section of the manual contains a brief description of each of the functions on the

samaritan® PAD. This section is a good starting point for new users of the samaritan®

PAD as it introduces each control on the device and explains their use. Figure 1

illustrates each of these controls. The controls available on the samaritan® PAD is:

1. ON/Off button

Use the On/Off button to turn the samaritan® PAD on or off.

2. Status Indicator

This indicator is a green icon that flashes approximately every five seconds

when the device is operating correctly. When the Status Indicator isn’t flashing

there is a problem with the device.

3. Speaker

The device provides audible prompts and information on the status of the

device.

10 © Heartsine Technologies

4. PAD-Pak™

The patient pads and battery are contained in a tray on the underside of the

device. The pads are attached to the device by a 1-meter cable.

5. Shock button

The Shock button can be pressed to deliver a shock when a shock is advised

by the device. When a shock is advised, the Shock button is illuminated.

6. Electrode Connection Indicator

The electrode connection arrows are illuminated when the pads need to be

applied to the patient or are not correctly attached.

7. Data Port

The Data Port is provided so that you can connect the samaritan® PAD to a

PC computer and download therapy information. In order to download

information, connect the samaritan® PAD to your computer using the data-

recovery cable. Saver™ data management software for the samaritan® PAD

must be installed on your PC in order to review the event data.

NEW Guideline version AHA/ERC 2000 or AHA/ERC 2005.

Figure 1 – samaritan®

PAD Controls

PAD User Manual

3.3 Samaritan

PAD

Symbols

The samaritan® PAD device and Pad-Pak use certain symbols to represent warnings.

Depending on the type of danger apparent, different symbols are used.

The table below provides an outline of the different symbols used:

Symbol Meaning

This symbol appears on the samaritan® PAD and represents a

general warning to take care.

This symbol appears on the samaritan® PAD and indicates that the

samaritan® PAD uses a defibrillation protected Type BF patient

connection.

This symbol appears on the samaritan® Pad-Pak™ and represents

a reference to the user manual.