HeartSine samaritan PAD SAM 500P User manual

HeartSine samaritan PAD
with CPR Advisor
SAM 500P
User Manual

2
Contents
Contents 2
Warnings and Cautions 4
Introduction 9
The HeartSine Samaritan PAD with CPR-
Advisor SAM 500P 9
Sudden Cardiac Arrest (SCA) 9
Ventricular brillation 9
CPR Quality 10
Impedance cardiogram (ICG) 10
Recommended training 11
CPR metronome 11
SAM 500P Overview 12
Preparation 13
Unpacking 13
Checks before putting into service 13
Guidelines for storage 15
Register your SAM 500P 15
Using the SAM 500P 16
When to use 16
Using the SAM 500P 16
After use 17
Service and Maintenance 19
Tracking Requirements 20
Data Management 21
Troubleshooting 22
Status indicator ashing red 22
Low battery warning 22
Memory full warning 22
Audible warnings 22
Device service required 23
Sources of support 23
Warranty exclusion 23
Technical Data 24
Appendix A 37
Voice prompts 37

3
Symbols used in this manual
Warning: Risk of death or
serious injury
Caution: Risk of injury
Notice: Risk of damage to data
or material
i
Further information
Symbols used on this device
On/Off
IP56 Ingress protection classied as IP56
according to EN 60529
Consult operating instructions
Follow instructions for use
Single use item. Do not re-use
Debrillation protected,
Type BF connection
Do not expose to high heat or open
ame. Do not incinerate
Does not contain natural rubber latex
Non-sterile
Recyclable
Non- rechargeable battery
Do not short circuit battery
Do not crush battery
Temperature limitation as indicated
Use by yyyy/mm
Dispose of in accordance with country
requirements
3XN6
Automated External Debrillator
With respect to electrical shock, re and
mechanical hazards only in accordance with
• ANSI/AAMI ES60601-1:2005
• CSA C22.2 NO. 60601-1:2008
• IEC60601-2-4:2010
• UL60601-1:2006
• CSA C22.2 No.601.1 M90
• IEC60601-2-4:2002

4
Warning
Patients suitable for treatment
The SAM 500P has been designed to
work on unconscious, nonresponsive
patients. If the patient is responsive or
conscious, do not use the SAM 500P to
provide treatment.
The SAM 500P uses an interchangeable
battery and electrode pack called Pad-
Pak. The SAM 500P in combination with
an adult Pad-Pak is suitable for use on
patients of over 25 kilograms (55 pounds)
in weight or equivalent to a child of
approximately eight years old or over.
For use on children, remove the adult
Pad-Pak and install a paediatric Pad-Pak.
If a paediatric Pad-Pak or an alternative
suitable debrillator is not available, you
may use an adult system.
If you treat a paediatric patient with
an adult Pad-Pak, ignore any voice
prompts regarding the quality of the
cardiopulmonary resuscitation (CPR). The
CPR Advisor is currently only intended to
provide feedback on adult patients.
Do not delay treatment trying to nd out
the patient’s exact age and weight.
Risk of electric shock
The SAM 500P delivers therapeutic
electrical shocks that can cause serious
harm to either operators or bystanders.
Take care to ensure that nobody touches
the patient when a shock is to be
delivered.
Avoid opening or repairing
The SAM 500P has no serviceable
parts. Do NOT open or repair the device
under any circumstances as there could
be danger of electric shock. If damage
is suspected, replace the SAM 500P
immediately.
Warnings and Cautions

5
Avoid explosive or ammable
gases
It has been determined that the SAM
500P is safe to use with oxygen mask
delivery systems. However, to avoid
the risk of an explosion, it is strongly
advised that you do NOT use the SAM
500P in the vicinity of explosive gases,
including ammable anaesthetics or
concentrated oxygen.
Caution
Correct placement of the electrode
pads
Proper placement of the SAM 500P’s
electrode pads is critical. You must strictly
observe the instructions shown in the
Quick Start Guide and on the device.
Wrong placement, or the presence of
air, hair, surgical dressings or medicine
patches between the pads and the skin,
could cause skin burns. Slightly red skin
after shock therapy is normal.
Do not touch the patient during
analysis
Touching the patient during the analysis
phase of treatment can cause interference
with the diagnostic process. Avoid contact
with the patient while analysis is being
carried out. The device will instruct you
when it is safe to touch the patient.

6
Do not use if the pouch containing
the electrodes is not sealed
The Pad-Pak is a single-use item and you
must replace it after each use or if pouch
that seals debrillation pads has been
broken or compromised in any way. If you
suspect that the Pad-Pak is damaged, you
must replace it immediately.
Notice
Susceptibility to electromagnetic
interference
To safeguard against interference, you
must operate the SAM 500P at least 2
m (6 feet) away from all radio frequency
devices and other susceptible equipment.
Alternatively, switch off the equipment
affected by or causing electromagnetic
interference.
Temperature range for operation
The SAM 500P, with its battery, pads and
electrodes, is designed to operate in the
temperature range of 0 ºC to 50 ºC. Use of
the device outside this range may cause
malfunction.
Environmental protection
The IP56 rating does not cover the
immersion of any part of the SAM 500P
in water or any type of uid. Contact with
uids may seriously damage the device or
cause re or a shock hazard.
Warnings and Cautions

7
Prolonging standby life
Do not turn the device on unnecessarily
as this may reduce the standby life of
the device.
Standby storage outside the range of 0 ºC
to 50 ºC may decrease the shelf-life of
the device.
Do not test on simulators and
manikins
Our devices cannot be tested
using industry-standard simulators
and manikins.
Standard simulators have a constant r-r
spacing and do not produce the variability
displayed in the normal human heart. Our
algorithm uses heart rate variability as
one of its criteria for measuring ventricular
brillation (VF). Consequently we do not
recommend the use of normal simulators
to test our device.
Further Information
Use of this manual
It is important that you read this manual
carefully before using the HeartSine
Samaritan PAD with CPR-Advisor SAM
500P. This manual is presented in support
of any training you may have received.
If you have any questions, contact your
authorised distributor or HeartSine
Technologies directly for advice or
explanation.
The information in this manual 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.
i

8
Warnings and Cautions
Operator training
HeartSine recommends that the
SAM 500P is used by people trained
in cardiopulmonary resuscitation –
debrillation (CPR-D).
Use of accessories
The SAM 500P is a self-contained device.
Do not use any unauthorised accessories
with it. The SAM 500P may malfunction if
non-approved accessories are used.
Regular maintenance
Check the device periodically. See
‘Service and Maintenance’ on page 19.
Correct disposal of the device
Dispose of the device in accordance with
the European WEEE Directive, or contact
your HeartSine distributor. Please follow
the ‘After use’ on page 17.
Compliance with local regulations
Check with the relevant local government
health department for information about
any requirements associated with
ownership and use of a debrillator in the
region where it is to be used.

9
The HeartSine Samaritan PAD with
CPR-Advisor SAM 500P
The HeartSine Samaritan PAD with CPR-
Advisor SAM 500P is a semi-automatic
external debrillator designed to quickly
deliver a debrillation shock to victims of
Sudden Cardiac Arrest (SCA).
The SAM 500P is designed to operate
in accordance with the joint European
Resuscitation Council (ERC) and
American Heart Association (AHA)
2010 guidelines on Cardiopulmonary
Resuscitation (CPR) and Emergency
Cardiovascular Care (ECC).
Sudden Cardiac Arrest (SCA)
Sudden cardiac arrest is a condition in
which the heart suddenly stops pumping
effectively due to a malfunction of the
heart’s electrical system. Often victims
of SCA have no prior warning signs
or symptoms. SCA can also occur
in people with previously diagnosed
heart conditions. Survival from SCA
depends on immediate cardiopulmonary
resuscitation (CPR).
The use of an external debrillator within
the rst few minutes of collapse can
greatly improve patient’s chances of
survival. Heart attack and SCA are not
the same, though sometimes a heart
attack can lead to an SCA. If you are
experiencing symptoms of a heart attack
(chest pain, pressure, shortness of breath,
tight feeling in the chest or elsewhere
in the body), seek emergency medical
attention immediately.
Ventricular brillation
The normal electrical rhythm by which the
heart muscle contracts to create blood
ow around the body is known as normal
sinus rhythm (NSR). Ventricular brillation
(VF), caused by chaotic electrical signals
in the heart, is often the cause of SCA.
In victims of SCA it is possible to re-
establish normal sinus rhythm by means
of an electric shock across the heart. This
treatment is called debrillation.
Introduction

10
CPR Quality
When providing cardiopulmonary
resuscitation (CPR) treatment to a victim
of sudden cardiac arrest, it is vital the
chest compressions are of a good quality.
If the quality of the CPR provided is good,
the chances of successfully resuscitating a
patient are greatly increased.
Research has demonstrated that non-
professional responders regularly provide
ineffective CPR due to inexperience. As
a response to this problem, HeartSine
has developed the SAM 500P with
CPR-Advisor.
The SAM 500P with CPR-Advisor can
provide feedback to rescuers on the
effectiveness of the cardiopulmonary
resuscitation (CPR) they are providing
to the victim. The SAM 500P uses
ICG measurements to analyse the
effectiveness and rate of compressions
given and then, based on this analysis,
advises the rescuer to push harder, faster
or slower as appropriate. The SAM 500P
uses both audible and visual prompts to
give the responder feedback on the quality
of the compressions administered.
Warning: The CPR Advisor
function is intended for
use on adult patients only.
If a paediatric Pad-Pak is
used, the CPR function is
disabled. In this case, the
rescuer is prompted to begin
CPR but receives no CPR
Advisor feedback.
Impedance cardiogram (ICG)
The impedance cardiogram is a method
of measuring changes in the patient’s
impedance due to motion, blood ow and
changes to the shape of the heart. The
SAM 500P uses these measurements
to estimate the impedance changes in
the chest and so as a way to determine
the effectiveness of compressions given
during CPR.
Introduction

11
Recommended training
SCA is a condition requiring immediate
emergency medical intervention. Due
to the nature of the condition, this
intervention can be performed before
seeking the advice of a physician.
To properly diagnose this condition,
HeartSine recommends that all
potential users of the SAM 500P
are fully trained in cardiopulmonary
resuscitation (CPR), basic life support
(BLS) and, in particular, the use of
an automated external debrillator.
HeartSine also recommends that
this training be kept up to date
by regular refresher courses as
and when recommended by your
training provider.
If potential users of the SAM 500P
are not trained in these techniques,
contact your authorised distributor
or HeartSine Technologies directly.
Either can arrange for training to be
provided. Alternatively contact your
local government health department
for information on certied training
organisations in your region.
CPR metronome
The SAM 500P will play an audible
click and ash the Safe To Touch
indicator at a rate compliant with
current AHA/ERC guidelines. This
feature is referred to as the CPR
metronome. Responders should
use this as a guide to the rate for
performing compressions.

12
Attach pads icon
The action arrows around this
icon will ash to instruct you
to attach the electrode pads to
the patient as indicated.
Status indicator
When the indicator is
ashing green the SAM
500P is ready for use.
On/Off button
Press this button to turn
the device on or off.
Safe to touch icon
It is safe to touch the patient
when the action arrows
around this icon are ashing.
Action arrows
CPR advisor
icon
Speaker
Paediatric
ready icon
Do not touch icon
Do not touch the patient
when the action arrows
around this icon are
ashing. The SAM 500P
may be analysing the
patient’s heart rhythm or
about to charge, preparing
to deliver a shock.
Data port
Shock button
Press this button
to deliver a
therapeutic shock.
Electrode drawerGreen tab
SAM 500P Overview

13
Unpacking
Check that the contents include the User
Manual, soft case, Pad-Pak, guarantee
card and Quick Start Guide.
A Pad-Pak is a single-use removable
battery and electrode pack in one unit. It is
available in two versions: a pink coloured
Pad-Pak for use with children and a grey
coloured Pad-Pak for use with adults (see
the illustration below).
Checks before putting into service
Check the expiry date (year/month) on the
rear of the Pad-Pak (see the illustration
below). If the expiry date has passed, you
must replace the Pad-Pak.
2017 / 05
Preparation
Paediatric Pad-Pak
Adult Pad-Pak

14
Unpack the Pad-Pak. Retain the
packaging in case you need to return
the Pad-Pak to HeartSine. Insert the
Pad-Pak into the SAM 500P (see the
illustration below).
The SAM 500P will run a self-test routine.
The action arrows will ash during this
process. On successful completion of the
self-test routine, the green status indicator
(see ‘SAM 500P Overview’ on page
12) will blink. If so, your SAM 500P is
ready for use.
Notice: Do NOT pull the green
tab on the Pad-Pak. If you have
opened the electrode drawer,
you must replace your Pad-Pak.
Turn on the SAM 500P by pressing on
the front panel. To check that the device is
operating correctly, listen for appropriate
voice prompts and make sure that no
warning messages are played.
Notice: Only turn the SAM 500P
on ONCE. If you turn it on and
off repeatedly, you will exhaust
the batteries prematurely
and you will need to replace
the Pad-Pak.
Turn off the SAM 500P by pressing on
the front panel. Check the status indicator
(see ‘SAM 500P Overview’ on page
12) is ashing green. If you have heard
no warning messages and the status
indicator is ashing green, the device is
ready for use.
Preparation

15
Guidelines for storage
Place the SAM 500P in its supplied
soft carry case. Store the SAM 500P in
an unobstructed, secure location in a
clean, dry environment. Be sure to store
according to specications (see ‘Technical
Data’ on page 24).
Notice: HeartSine recommends
that you keep a spare Pad-Pak
with your SAM 500P. You can
store it in the rear section of
the soft carry case.
Register your SAM 500P
Complete the guarantee card and return it
to your authorised distributor or HeartSine
Technologies directly (see ‘Tracking
Requirements’ on page 20).

16
When to use
The HeartSine Samaritan PAD with CPR-
Advisor SAM 500P is indicated for use on
victims of sudden cardiac arrest who are
exhibiting the following signs:
Unconscious
Not breathing
No life signs
The SAM 500P has been designed to
work on unconscious, nonresponsive
patients. If the patient is responsive or
conscious, do not use the SAM 500P to
provide treatment.
The SAM 500P is suitable for use on
patients of over 25 kg (55 lbs) in weight or
equivalent to a child of approximately eight
years old or over.
For use on younger children, remove the
adult Pad-Pak and install a paediatric
Pad-Pak. If a paediatric Pak-Pad or an
alternative suitable debrillator is not
available, you may use an adult Pad-Pak.
Using the SAM 500P
Refer to the separate Quick Start Guide.
During use the SAM 500P will give
extensive voice prompts to guide the user.
For full list of voice prompts see ‘Appendix
A’ on page 37.
Notice: PAD aborts a ready to
shock condition once a non-
shockable rhythm is detected.
Using the SAM 500P

17
After use
Turn off the SAM 500P by pressing on
the front panel.
Remove the electrode pads from
the patient and stick them together
‘face to face’. The electrodes may be
contaminated with human bodily tissue,
uid or blood. Dispose of the electrodes
separately as an infectious waste material.
The Pad-Pak is a single-use item
and must be replaced after each use.
Remove the Pad-Pak by pressing the
two tabs on either side of the Pad-Pak.
The Pad-Pak will slide forward (see the
illustration below).
Do not dispose of the SAM 500P or Pad-
Pak in the normal waste. Dispose of it at
an appropriate recycling facility according
to local requirements. Alternatively
return it to your distributor for disposal or
replacement.
Check the SAM 500P for dirt or
contamination. If necessary, clean it
using a soft cloth dampened by one of the
following:
Soapy water.
Isopropyl alcohol (70% solution).
Caution: Do not immerse any
part of the SAM 500P in water
or any type of uid. Contact
with uids may seriously
damage the device or cause a
re or a shock hazard.
Notice: Do not clean the SAM
500P with abrasive materials,
cleaners or solvents.

18
Using the SAM 500P
Check the SAM 500P for damage. If
the SAM 500P is damaged, replace it
immediately.
Install a new Pad-Pak. Before installing,
check the Pad-Pak expiry date (see
‘Preparation’ on page 13). After
installation check the status indicator is
blinking green.

19
HeartSine recommends users perform regular maintenance checks. A suggested
maintenance check would be:
Weekly
1. Check the status indicator. If the green status indicator is not ashing
approximately every 5 seconds, a problem has been detected. See
‘Troubleshooting’ on page 22. The SAM 500P performs a self-test routine at
midnight GMT on Sunday. During this self-test period the status light blinks red
but returns to green on successful completion of the self-test routine. The self-test
takes no more than 10 seconds to complete. If the status indicator continues to
ash red the SAM 500P has a fault (see ‘Troubleshooting’ on page 22).
Monthly
2. If the device shows any signs of physical damage, contact your authorised
distributor or HeartSine Technologies directly.
3. Check the expiry date of the SAM 500P Pad-Pak (see ‘Preparation’ on page 13
for the location of the date). If the date has expired, replace with a new Pad-Pak or
contact your local HeartSine distributor for a replacement.
4. If you hear a warning message when you turn on your SAM 500P or if, for any
reason, you have suspicions that your SAM 500P is not working correctly,
contact your authorised distributor or HeartSine Technologies directly (support@
HeartSine.com).
Service and Maintenance

20
The Medical Devices Regulations require us to track the location of all medical
devices sold.
It is important that you complete the warranty card with your details and return it to your
authorised distributor or HeartSine Technologies directly.
Alternativley please send an email to [e-mail] containing the following
information:
Name
Address
Device serial number
or use our on-line registration tool at https://secure.heartsine.com/UserRegistration.html
Your participation will allow us to contact you with any important notications about the
SAM 500P, such as any future software updates or eld safety corrective actions.
If there is a change in the information you have provided to us, such as a change
of address or a change in ownership of your SAM 500P, please contact us with the
updated information.
Tracking Requirements