HeartSine samaritan PAD SAM 300P User manual

HeartSine samaritan PAD
SAM 300P
User Manual

2
Contents
Contents 2
Warnings and Cautions 4
Introduction 9
The HeartSine samaritan PAD SAM 300P 9
Sudden Cardiac Arrest (SCA) 9
Ventricular brillation 9
Recommended training 10
CPR metronome 10
SAM 300P Overview 11
Preparation 12
Unpacking 12
Checks before putting into service 12
Guidelines for storage 14
Register your SAM 300P 14
Using the SAM 300P 15
When to use 15
Using the SAM 300P 15
After use 16
Service and Maintenance 18
Tracking Requirements 19
Data Management 20
Troubleshooting 21
Status indicator ashing red 21
Low battery warning 21
Memory full warning 21
Audible warnings 21
Device service required 22
Sources of support 22
Warranty exclusion 22
Technical Data 23
Appendix A 34
Voice prompts 34

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
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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 300P has been designed to
work on unconscious, nonresponsive
patients. If the patient is responsive or
conscious, do not use the SAM 300P to
provide treatment.
The SAM 300P uses an interchangeable
battery and electrode pack called Pad-
Pak. The SAM 300P 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.
Do not delay treatment trying to nd out
the patient’s exact age and weight.
Risk of electric shock
The SAM 300P 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 300P 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 300P
immediately.
Warnings and Cautions

5
Avoid explosive or ammable
gases
It has been determined that the SAM
300P 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
300P in the vicinity of explosive gases,
including ammable anaesthetics or
concentrated oxygen.
Caution
Correct placement of the electrode
pads
Proper placement of the SAM 300P’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 300P 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 300P, 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 300P
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 SAM 300P. 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.
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8
Warnings and Cautions
Operator training
HeartSine recommends that the
SAM 300P is used by people trained
in cardiopulmonary resuscitation –
debrillation (CPR-D).
Use of accessories
The SAM 300P is a self-contained device.
Do not use any unauthorised accessories
with it. The SAM 300P may malfunction if
non-approved accessories are used.
Regular maintenance
Check the device periodically. See
‘Service and Maintenance’ on page 18.
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 16.
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 SAM
300P
The HeartSine Samaritan PAD SAM 300P
is a semi-automatic external debrillator
designed to quickly deliver a debrillation
shock to victims of Sudden Cardiac
Arrest (SCA).
The SAM 300P 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
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 300P 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 300P 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 300P 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.
Introduction

11
SAM 300P Overview
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
300P is ready for use.
On/Off button
Press this button to turn
the device on or off.
Action arrows
Speaker
Paediatric
ready icon
Data port
Shock button
Press this button
to deliver a
therapeutic shock.
Electrode drawerGreen tab
Safe to touch icon
It is safe to touch the
patient when the action
arrows around this icon
are ashing.
Do not touch icon
Do not touch the patient
when the action arrows
around this icon are
ashing. The SAM 300P
may be analysing the
patient’s heart rhythm
or about to charge,
preparing to deliver a
shock.

12
Preparation
Paediatric Pad-Pak
Adult Pad-Pak
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

13
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 300P (see the illustration
below). Listen for the “click” sound and
ensure both tabs are fully engaged.
The SAM 300P 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 300P Overview’ on page
11) will blink. If so, your SAM 300P 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 300P 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 300P
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 300P by pressing on
the front panel. Check the status indicator
(see ‘SAM 300P Overview’ on page
11) is ashing green. If you have heard
no warning messages and the status
indicator is ashing green, the device is
ready for use.

14
Guidelines for storage
Place the SAM 300P in its supplied
soft carry case. Store the SAM 300P in
an unobstructed, secure location in a
clean, dry environment. Be sure to store
according to specications (see ‘Technical
Data’ on page 23).
Notice: HeartSine recommends
that you keep a spare Pad-Pak
with your SAM 300P. You can
store it in the rear section of
the soft carry case.
Register your SAM 300P
Complete the guarantee card and return it
to your authorised distributor or HeartSine
Technologies directly (see ‘Tracking
Requirements’ on page 19).
Preparation

15
When to use
The HeartSine Samaritan PAD SAM 300P
is indicated for use on victims of sudden
cardiac arrest who are exhibiting the
following signs:
Unconscious
Not breathing
No life signs
The SAM 300P has been designed to
work on unconscious, nonresponsive
patients. If the patient is responsive or
conscious, do not use the SAM 300P to
provide treatment.
The SAM 300P 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 300P
Refer to the separate Quick Start Guide.
During use the SAM 300P will give
extensive voice prompts to guide the user.
For full list of voice prompts see ‘Appendix
A’ on page 34.
Notice: PAD aborts a ready to
shock condition once a non-
shockable rhythm is detected.
Using the SAM 300P

16
After use
Turn off the SAM 300P 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 300P 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 300P 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 300P 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
300P with abrasive materials,
cleaners or solvents.
Using the SAM 300P

17
Check the SAM 300P for damage. If
the SAM 300P is damaged, replace it
immediately.
Install a new Pad-Pak. Before installing,
check the Pad-Pak expiry date (see
‘Preparation’ on page 12). After
installation check the status indicator is
blinking green.

18
Service and Maintenance
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 21. The SAM 300P 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 300P has a fault (see ‘Troubleshooting’ on page 21).
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 300P Pad-Pak (see ‘Preparation’ on page 12
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 300P or if, for any
reason, you have suspicions that your SAM 300P is not working correctly,
contact your authorised distributor or HeartSine Technologies directly (support@
HeartSine.com).

19
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 300P, 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 300P, please contact us with the updated
information.
Tracking Requirements

20
The HeartSine Saver™ EVO software
is an optional accessory. Contact your
authorised distributor or HeartSine
Technologies directly about the After-Use
Data Management Service.
1. Connect the supplied USB
cable to the SAM 300P (see
illustration below).
2. Connect the USB cable to a PC.
3. Launch the HeartSine Saver™
EVO utility.
Notice. The SAM 300P should
only be connected to an
IEC60950 PC.
Caution. You cannot debrillate
while the SAM 300P is
connected to a PC.
For further information on this
optional accessory, contact your
authorised distributor or HeartSine
Technologies directly.
Data Management