AED Leader Heartsine Samaritan PAD-350P User manual

This manual for Heartsine Samaritan PAD-350P is brought to you
by AED Leader, a leading distributor of automated external
defibrillators and original manufacturer accessories.
Phone: [phone]
Website: https://www.aedleader.com

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Contents
Contents 2
Indications for Use 4
Indications for use 4
Contraindications for use 4
Intended users 4
Warnings and Cautions 5
Introduction 10
The SAM 350P 10
Sudden cardiac arrest (SCA) 10
Ventricular brillation 10
Recommended training 11
CPR metronome 11
SAM 350P Overview 12
Preparation 13
Unpacking 13
Checks before putting into service 13
Preparation checklist 15
Using the SAM 350P 16
When to use 16
Using the SAM 350P 16
After use 17
Paediatric-Pak 19
Service and Maintenance 21
Tracking Requirements 22
Data Management 23
Troubleshooting 24
Status indicator ashing red 24
Low battery warning 24
Memory full warning 24
Audible warnings 24
Device service required 25
Sources of support 25
Warranty exclusion 25
Technical Data 26
List of Voice Prompts 38
Adult patient/child patient 38
If a shock is not required… 38
If a shock is required… 38

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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
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
Follow instructions for use
e.g. “yyD01234567”
yy = year of manufacture

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Indications for use
The HeartSine®samaritan®PAD
350P is indicated for use on victims of
cardiac arrest who are exhibiting the
following signs:
• Unconscious
• Not breathing
• Without circulation
The samaritan PAD 350P (SAM 350P) is
indicated for use on patients greater than 8
years old or over 25 kg (55 lbs) when used
with the adult samaritan Pad-Pak™. The
SAM 350P is indicated for use on children
between 1 and 8 years of age or up to 25
kg (55 lbs) when used with the samaritan
Paediatric-Pak™.
Contraindications for use
If the patient is responsive or conscious,
do not use the SAM 350P to provide
treatment.
Intended users
The SAM 350P is intended for use by
personnel who have been trained in its
operation. Users should have received
training in basic life support / AED,
advanced life support or a physician-
authorised emergency medical response
training program.
Indications for Use

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Warning
Patients suitable for treatment
The SAM 350P has been designed to
work on unconscious, nonresponsive
patients. If the patient is responsive or
conscious, do not use the SAM 350P to
provide treatment.
The SAM 350P uses an interchangeable
battery and electrode pack called Pad-
Pak. The SAM 350P 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 smaller children (from 1 to 8
years old), remove the adult Pad-Pak and
install a Paediatric-Pak. If a Paediatric-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 350P 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 350P 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 350P
immediately.
Warnings and Cautions

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Avoid explosive or ammable
gases
It has been determined that the SAM
350P 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
350P in the vicinity of explosive gases,
including ammable anaesthetics or
concentrated oxygen.
Caution
Correct placement of the electrode
pads
Proper placement of the SAM 350P
electrode pads is critical. You must strictly
observe the instructions shown in the
Emergency User 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 reduce debrillation effectiveness.
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.
Warnings and Cautions

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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 the
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 350P at least 2 m
(6 feet) away from all radio frequency
devices. Alternatively, switch off the
equipment causing the electromagnetic
interference.
Temperature range for operation
The SAM 350P, with its battery, pads and
electrodes, is designed to operate in the
temperature range of 0 ºC to 50 ºC (50 °F
to 122 °F). Use of the device outside this
range may cause malfunction.
Ingress protection
The IP56 rating does not cover the
immersion of any part of the SAM 350P
in water or any type of uid. Contact with
uids may seriously damage the device or
cause re or a shock hazard.

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Prolonging battery life
Do not turn on the device unnecessarily
as this may reduce the standby life of
the device.
Standby storage outside the range of 0 ºC
to 50 ºC (50 °F to 122 °F) may decrease
the shelf-life of the Pad-Pak.
Do not test on simulators and
manikins
Our devices cannot be tested
using industry-standard simulators
and manikins.
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 SAM 350P.
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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Warnings and Cautions

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Operator training
The SAM 350P is intended for use by
personnel who have been trained in its
operation. Users should have received
training in basic life support / AED,
advanced life support or a physician-
authorised emergency medical response
training program.
Use of accessories
The SAM 350P is a self-contained device.
Do not use any unauthorised accessories
with it. The SAM 350P may malfunction if
non-approved accessories are used.
Regular maintenance
Check the device periodically. See
‘Service and Maintenance’ on page 21.
Correct disposal of the device
Dispose of the device in accordance
with your national or local regulations, 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.

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The SAM 350P
The SAM 350P is a semi-automatic
external debrillator designed to quickly
deliver a debrillation shock to victims of
sudden cardiac arrest (SCA).
The SAM 350P is designed to operate
in accordance with the joint European
Resuscitation Council (ERC) and
American Heart Association (AHA)
2015 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 and effective 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

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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 350P 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 350P 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
During CPR the SAM 350P will play
an audible beep and ash the “Safe To
Touch” indicator at a rate compliant with
2015 AHA/ERC guidelines. This feature
is referred to as the CPR metronome.
Use the metronome as a guide on how
frequently to compress a patient’s chest if
you need to apply CPR.

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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
350P is ready for use.
On/Off button
Press this button to turn
the device on or off.
Do not touch icon
Do not touch the patient when
the action arrows around this
icon are ashing. The SAM 350P
may be analysing the patient’s
heart rhythm or about to charge,
preparing to deliver a shock.
Action arrows
Speaker
Paediatric
ready icon
Safe to touch icon
It is safe to touch the
patient when the action
arrows around this icon
are ashing.
Data port
Shock button
Press this button
to deliver a
therapeutic shock.
Electrode drawerGreen tab
SAM 350P Overview

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Unpacking
Check that the contents include the User
Manual, soft case, Pad-Pak, Warranty
Card and Emergency User Guide.
A Pad-Pak is a single-use removable
battery and electrode pack in one unit. It
is available in two versions1: grey coloured
Pad-Pak for use with adults and a pink
coloured Paediatric-Pak for use with
children (see the illustration below).
1 A third version is also available specically for airlines
Checks before putting into service
1. 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.
Preparation
Paediatric-Pak
Adult Pad-Pak
2017 / 05

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2. Unpack the Pad-Pak. Retain the
packaging in case you need to return
the Pad-Pak to HeartSine. Place the
SAM 350P on a at surface. Insert
the Pad-Pak into the SAM 350P (see
the illustration below). Listen for the
“click” sound and ensure both tabs
are fully engaged.
3. If required, the SAM 350P 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 350P Overview’ on page
12) will blink. If so, your SAM
350P is ready for use.
4. Turn on the SAM 350P by pressing
on the front panel to check that
the device is operating correctly.
Listen for the voice prompts but do
NOT follow them. Make sure that no
warning messages are played.
Notice: Do NOT pull the green
tab on the Pad-Pak. If you have
opened the electrode drawer,
you may have to replace
your Pad-Pak.
Only turn the SAM 350P on
ONCE. If you turn it on and off
repeatedly, you will exhaust
the batteries prematurely
and you may need to replace
the Pad-Pak.
5. Turn off the SAM 350P by pressing
on the front panel. Check the
status indicator (see ‘SAM 350P
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

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6. Place the SAM 350P in its supplied
soft carry case. Store the SAM
350P in an unobstructed, secure
location in a clean, dry environment
specically where it will be seen and
heard. Be sure to store according to
specications (see ‘Technical Data’
on page 26).
Standby 0 °C to 50 °C
temperature: (50 °F to 122 °F)
Relative 5% to 95%
humidity: (non-condensing)
Notice: HeartSine recommends
that you keep a spare Pad-Pak
with your SAM 350P. You can
store it in the rear section of
the soft carry case.
7. Complete the Warranty Card and
return it to your authorised distributor
or HeartSine Technologies directly
(see ‘Tracking Requirements’
on page 22).
Preparation checklist
❏Step 1. Check the Pad-Pak expiry date.
❏Step 2. Install the Pad-Pak.
❏Step 3. Check for a successful
completion of the self-test routine.
❏Step 4. Turn on to check operation.
❏Step 5. Turn off.
❏Step 6. Store the SAM 350P correctly.
❏Step 7. Register your SAM 350P.
❏Step 8. Create a service schedule
(see ‘Service and Maintenance’
on page 21).

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When to use
The SAM 350P is indicated for use on
victims of sudden cardiac arrest who are
exhibiting the following signs:
Unconscious
Not breathing
Without circulation
The SAM 350P has been designed to
work on unconscious, nonresponsive
patients. If the patient is responsive or
conscious, do not use the SAM 350P to
provide treatment.
The SAM 350P 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 smaller children (from 1 to 8
years old), remove the adult Pad-Pak and
install a Paediatric-Pak.
If a Paediatric-Pak or an alternative
suitable debrillator is not available, you
may use an adult Pad-Pak.
Using the SAM 350P
Refer to the separate Emergency User
Guide. During use the SAM 350P will give
extensive voice prompts. For full list of
voice prompts see ‘List of Voice Prompts’
on page 38.
Notice: The SAM 350P aborts
a ready to shock condition
once a non-shockable rhythm
is detected.
Using the SAM 350P

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After use
1. Turn off the SAM 350P by pressing
on the front panel.
2. 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.
3. The Pad-Pak contains Lithium
batteries. It 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 350P
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.
4. Check the SAM 350P 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 350P 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
350P with abrasive materials,
cleaners or solvents.

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5. Check the SAM 350P for damage. If
the SAM 350P is damaged, replace
it immediately.
6. 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.

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Paediatric-Pak
Using the Paediatric-Pak
The Paediatric-Pak is intended to provide
therapy for paediatric (child) victims of
SCA between the ages of 1 and 8 years
old who are:
Unconscious
Not breathing
Without circulation
Electrode Placement:
For paediatric patients there are two
options for electrode placement:
a. If a child’s chest is small it may be
necessary to place one pad on the child’s
BARE chest in the centre, and the other
pad on the child’s BARE back in the centre
of the ribcage as shown in Method a).
Method a)

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b. If a child’s chest is large enough to
permit a 2.5cm (1 inch) gap between the
pads, pad placement can be used similar
to adult placement. Place one pad on
child’s BARE upper right chest above
nipple and one pad on child’s BARE lower
left ribcage below nipple as shown in
Method b).
Method b)
Electrodes can be placed on the child’s
chest if their chest is large enough OR if
trauma does not allow for the placement
as shown in Method a).
Warning: Debrillation
electrodes must be at least
approx 2.5 cm (1 inch) apart
and should never be touching
one another.
Warning: The Paediatric-
Pak contains a magnetic
component (surface strength
6500 gauss). Avoid storage
next to magnetically sensitive
storage media.
Warning: Not for use on
patients under 1 year old. For
use with children up to the age
of 8 years or up to 25kg (55lbs).
DO NOT DELAY THERAPY
IF YOU ARE NOT SURE OF
EXACT AGE OR WEIGHT.