HeartSine samaritan SAM 350P User manual

USER MANUAL
HeartSine®samaritan®PAD
SAM 350P Semi-Automatic Debrillator
SAM 360P Fully Automatic Debrillator
SAM 450P Semi-Automatic Debrillator

Use of This Manual
It is important that you read this manual carefully before using your samaritan®PAD.
This manual is presented in support of any training you may have received.
If you have any questions, contact your Authorized Distributor or
HeartSine®Technologies directly.
CAUTION:
U.S. Federal law restricts this device to sale by or on the order of a physician.

1
Contents
Indications for Use....................................... 2
Contraindications for use.............................2
Caution ...........................................................2
Warnings and Precautions........................... 3
Overview ......................................................6
Sudden Cardiac Arrest...................................6
Sinus Rhythm and Ventricular Fibrillation .....6
Ventricular Tachycardia.................................6
Treatment by AED..........................................6
Introduction................................................. 8
About the samaritan PAD.............................8
CPR Metronome.............................................8
CPR Rate Adviser............................................8
Recommended Training................................9
Safety and Eectiveness Data .....................9
SAM 350P Layout .........................................10
SAM 360P Layout..........................................11
SAM 450P Layout......................................... 12
Set-up ..........................................................13
Unpacking .....................................................13
Pad-Pak ..........................................................13
Putting the samaritan PAD
into Service...................................................14
Preparation Checklist.................................. 15
Using the samaritan PAD............................16
Pediatric-Pak ...............................................21
Treating Small Children and Infants ......... 21
Electrode Placement ................................... 21
Aer Using the samaritan PAD ................. 23
Cleaning the samaritan PAD ......................23
Downloading and Submitting Event
Information................................................. 24
Disposal ........................................................25
Tracking ...................................................... 26
Service and Maintenance........................... 27
Testing with Simulators
and Manikins ...............................................27
APPENDICES................................................ 28
Appendix A Symbols ..................................A-1
Appendix B Troubleshooting.....................B-1
Appendix C Technical Data........................C-1
Appendix D Voice Prompts....................... D-1
Appendix E
Safety and Eectiveness Data ..................E-1
SAM 350P 360P 450P User Manual

2
The HeartSine samaritan PAD SAM 350P (SAM 350P),
HeartSine samaritan PAD SAM 360P (SAM 360P) and
HeartSine samaritan PAD SAM 450P (SAM 450P)
all have the identical indications for use. Each is
indicated for use on victims of cardiac arrest who are
exhibiting the the following signs:
• Unconscious
• Not breathing
• Without circulation (without a pulse)
The devices are intended for use by personnel who
have been trained in their operation. Users should
have received training in basic life support/AED,
advanced life support or a physician-authorized
emergency medical response training program.
The devices are indicated for use on patients
greater than 8 years old or over 55 lb/25 kg when
used with the adult Pad-Pak™(Pad-Pak-01 or
Pad-Pak-07). They are indicated for use on children
between 1 and 8 years of age or up to 55 lb/25 kg
when used with the Pediatric-Pak™(Pad-Pak-02).
Contraindications for Use
If the patient is responsive or conscious, do not use
the samaritan PAD to provide treatment.
Caution
U.S. Federal law restricts this device to sale by or on
the order of a physician.
Indications for Use

3
WARNINGS
Patients Suitable for Treatment
The samaritan PAD has been designed to work
on unconscious, nonresponsive patients. If the
patient is responsive or conscious, do not use the
samaritan PAD to provide treatment.
The samaritan PAD uses an interchangeable battery
and electrode pack called Pad-Pak. The samaritan
PAD in combination with an adult Pad-Pak is
suitable for use on patients of over 55 lb (25 kg) 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 Pediatric-
Pak. If a Pediatric-Pak or an alternative suitable
debrillator is not available, you may use an adult
Pad-Pak.
If you treat a pediatric patient with an adult
Pad-Pak, ignore any voice prompts regarding the
rate of CPR. The SAM 450P CPR Rate Advisor is
currently only intended to provide feedback on
adult patients.
Do Not Delay Treatment
Do not delay treatment trying to nd out the
patient’s exact age and weight.
Risk of Electric Shock
The samaritan PAD delivers therapeutic electrical
shocks that can cause serious harm to either
users or bystanders. Take care to ensure that no
one touches the patient when a shock is to be
delivered.
Do Not Open or Repair
The samaritan PAD 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, immediately replace
the samaritan PAD.
Avoid Explosive or Flammable Gases
The samaritan PAD 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 samaritan PAD in the vicinity of
explosive gases, including ammable anesthetics
or concentrated oxygen.
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 the samaritan PAD is analyzing the patient.
The device will instruct you when it is safe to touch
the patient.
Warnings and Precautions
WARNINGS AND PRECAUTIONS

4
WARNINGS
Fully Automatic Debrillator (SAM 360P)
The SAM 360P is a fully automatic debrillator.
When required, it will deliver a shock to the patient
WITHOUT user intervention.
CPR Rate Advisor Function (SAM 450P)
The CPR Rate Advisor function is intended for use
on adult patients only. If a Pediatric-Pak is used, the
CPR Rate Advisor function is disabled. In this case,
the rescuer is prompted to begin CPR in time with
the metronome but receives no CPR Rate Advisor
feedback.
PRECAUTIONS
Correct Placement of Electrode Pads
Proper placement of the samaritan PAD electrode
pads is critical. You must strictly observe the
instructions shown on pages 19-22 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 eectiveness. Slightly red skin aer
shock therapy is normal.
Do Not Use Electrode Pads if Pouch is Not Sealed
The Pad-Pak and Pediatric-Pak are single-use
items which must be replaced aer each use or if
the pouch that seals the electrode pads has been
broken or compromised in any way. If you suspect
that the Pad-Pak or Pediatric-Pak is damaged,
replace it immediately.
Susceptibility to Electromagnetic Interference
To safeguard against interference, operate the
samaritan PAD at least 6 feet/2 meters away from
all radio frequency devices. Alternatively, switch
o the equipment causing the electromagnetic
interference.
Temperature Range for Operation
The samaritan PAD, with its battery and electrodes,
is designed to operate in the temperature range of
32°F to 122°F/0°C to 50°C. Use of the device outside
of this range may cause the device to malfunction.
Warnings and Precautions continued

5
WARNINGS AND PRECAUTIONS
Ingress Protection
The samaritan PAD has an IP56 rating against
dust and sprays of water. However, the IP56 rating
does not cover the immersion of any part of the
samaritan PAD in water or any type of uid. Contact
with uids may seriously damage the device or
cause re or a shock hazard.
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
32°F to 122°F/0°C to 50°C may decrease the
shelf-life of the Pad-Pak.
Operator Training
The samaritan PAD 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-authorized emergency medical
response training program.
Use of Accessories
The samaritan PAD is a self-contained device. Do
not use any unauthorized accessories with the
device as the samaritan PAD may malfunction if
non-approved accessories are used.
Regular Maintenance
Check the device periodically. See Service and
Maintenance on page 27.
Correct Disposal of the Device
Dispose of the device in accordance with your
national or local regulations, or contact your
Authorized Distributor for assistance. Please follow
the steps provided in Aer Using the samaritan PAD
on page 25.
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.

6
Overview
Sudden Cardiac Arrest
Sudden cardiac arrest (SCA) is a condition in which
the heart suddenly stops pumping blood eectively
due to a malfunction of the heart’s electrical system.
Oen victims of SCA have no prior warning signs
or symptoms. SCA also can occur in people with
previously diagnosed heart conditions. Survival
from SCA depends on immediate and eective
cardiopulmonary resuscitation (CPR).
The use of an external debrillator within the rst
few minutes of a collapse can greatly improve
a patient’s chance 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), immediately seek medical
attention.
Sinus Rhythm and Ventricular Fibrillation
The normal heart rhythm, known as sinus rhythm,
creates electrical activity resulting in coordinated
contraction of the heart muscle. This generates
normal blood ow around the body.
Ventricular brillation (V-b or VF) is a condition
in which there is uncoordinated contraction of the
heart muscle, making it quiver rather than contract
properly. Ventricular brillation is the most
commonly identied arrhythmia in SCA patients. 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.
Ventricular Tachycardia
Ventricular tachycardia (VT) is a type of tachycardia
(rapid heartbeat) that arises from improper
electrical activity of the heart. VT starts in
the bottom chambers of the heart, called the
ventricles. Although there are many dierent types
of VT, this arrhythmia can be potentially life-
threatening if the patient presents with no pulse
and is unresponsive. If not treated with immediate
debrillation VT may lead to other arrhythmias.
Treatment by AED
It is a common misconception that CPR alone
and calling emergency services is enough. CPR is
a temporary measure that maintains blood ow
and oxygen to the brain. CPR alone will not return a
heart to a normal rhythm during VF or VT. The key
to survival is debrillation – and the sooner
the better.
Debrillation is a common treatment for life-
threatening arrhythmias, mainly ventricular
brillation. Debrillation consists of delivering an
electrical shock to the heart with a device called
a debrillator. This restores normal heart muscle
contractions and allows normal sinus rhythm to
be restored by the body’s natural pacemaker in
the heart.

7
OVERVIEW
The samaritan PAD uses the HeartSine samaritan
ECG arrhythmia analysis algorithm. This algorithm
will evaluate the patient’s ECG to ascertain if a
therapeutic shock is appropriate. If a shock is
required, the samaritan PAD will charge and advise
the user to press the shock button (SAM 350P/450P)
or will automatically deliver a shock (SAM 360P). If
no shock is advised, the device will pause to allow
the user to deliver CPR.
It is important to note that cardiac debrillators,
like the HeartSine samaritan PAD, will not
administer a shock unless a lifesaving shock is
required.

8
This manual provides instructions for the following
models of the HeartSine samaritan PAD:
samaritan PAD 350P (SAM 350P)
samaritan PAD 360P (SAM 360P)
samaritan PAD 450P (SAM 450P)
About the samaritan PAD
The samaritan PAD family of AEDs is designed to
quickly deliver a debrillation shock to victims
of sudden cardiac arrest (SCA). Each samaritan
PAD is designed to operate in accordance with the
current joint American Heart Association (AHA) and
European Resuscitation Council (ERC) guidelines
on Cardiopulmonary Resuscitation (CPR) and
Emergency Cardiovascular Care (ECC).
While all of the samaritan PAD models are very
similar in use, there are distinct dierences
between the models as shown in Table 1 below.
The SAM 350P is a semi-automatic debrillator, the
SAM 360P is a fully automatic debrillator, and the
SAM 450P is a semi-automatic debrillator with
integrated CPR Rate Advisor™.
WARNING: The SAM 360P is a fully
automatic debrillator. When required, it will
deliver a shock to the patient WITHOUT user
intervention.
CPR Metronome
When the samaritan PAD instructs you to perform
CPR, you will hear an audible beep and see the Safe
to Touch indicator ash at a rate compliant with
2015 AHA/ERC guidelines. This feature, referred to
as the CPR metronome, will guide you to the rate at
which to compress a patient’s chest during CPR.
CPR Rate Advisor
When providing CPR treatment to a victim of sudden
cardiac arrest, it is vital the chest compressions are
Introduction
SAM 350P SAM 360P SAM 450P
Shock delivery Semi-Automatic Fully Automatic Semi-Automatic
Four-year electrode and battery life 444
Audible and visual indicators 444
CPR coaching with metronome 444
CPR Rate Advisor 4
Pediatric use-compatible (with Pediatric Pad-Pak) 444
Table 1. samaritan PAD AEDs

9
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 ineective CPR due to
inexperience.
The SAM 450P with CPR Rate Advisor provides
feedback to the rescuers on the rate of the CPR they
are providing to the victim. The SAM 450P uses
impedance cardiogram measurements to analyze
the speed of compressions and provide the user
with instructions to push faster or push slower or to
continue to provide compressions at a good speed
according to the AHA resuscitation guidelines. The
SAM 450P uses both audible and visual feedback to
give the responder instruction on CPR rate. Refer to
Technical Data in Appendix C on page C-7.
WARNING: The CPR Rate Advisor function
is intended for use on adult patients only. If a
Pediatric-Pak is used, the CPR function is disabled.
In this case, the rescuer is prompted to begin CPR
in time with the metronome but receives no
CPR Rate Advisor feedback.
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.
The samaritan PAD 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-authorized
emergency medical response training program.
HeartSine Technologies 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 samaritan PAD are
not trained in these techniques, contact your
Authorized 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 organizations in your area.
Safety and Eectiveness Data
Please refer to Appendix E for the potential risks
associated with the use of an AED and a summary
of SAM 350P, SAM 360P and SAM 450P safety and
eectiveness data.
INTRODUCTION

Status Indicator
The SAM 350P is ready for
use when this indicator is
ashing green.
On/O button
Press this button to
turn on or turn o
the device.
Do Not Touch Icon/
Action Arrows
Do not touch the patient when
the action arrows above this
icon are ashing. The SAM 350P
may be analyzing the patient’s
heart rhythm or about to
charge, in preparation to
deliver a shock.
Speaker
Listen for the
metronome and
verbal prompts.
Adult and
Pediatric Symbols
Indicates that the
SAM 350P is compatible
with both the Pad-Pak
and Pediatric-Pak.
Safe to Touch Icon/
Action Arrows
You may touch the
patient when the action
arrows around this icon
are ashing.
Shock Button
Press this button to deliver
a therapeutic shock.
Data Port
Plug the custom USB cable
into this port to download
event data from the AED.
(See Figure 8, page 24.)
Pad-Pak
Contains the battery
and electrode pads.
Green Tab
Pull this tab to release
the electrodes.
Attach Pads Icon/Action Arrows
Attach the electrode pads to the
patient’s bare chest as indicated
when the action arrows are ashing.
SAM 350P Layout
10
Introduction continued

Status Indicator
The SAM 360P is ready for
use when this indicator is
ashing green.
On/O button
Press this button to
turn on or turn o
the device.
Do Not Touch Icon/
Action Arrows
Do not touch the patient when
the action arrows above this
icon are ashing. The SAM
360P may be analyzing the
patient’s heart rhythm or
about to charge, in preparation
to deliver a shock.
Speaker
Listen for the
metronome and
verbal prompts.
Adult and
Pediatric Symbols
Indicates that the SAM
360P is compatible with
both the Pad-Pak and
Pediatric-Pak.
Safe to Touch Icon/
Action Arrows
You may touch the
patient when the
action arrows around
this icon are ashing.
Shock Icon
Flashes to indicate a shock
will be delivered.
Data Port
Plug the custom USB cable
into this port to download
event data from the AED.
(See Figure 8, page 24.)
Pad-Pak
Contains the battery
and electrode pads.
Green Tab
Pull this tab to release
the electrodes.
Attach Pads Icon/Action Arrows
Attach the electrode pads to the
patient’s bare chest as indicated
when the action arrows are ashing.
SAM 360P Layout
INTRODUCTION
11

12
Status Indicator
The SAM 450P is ready for
use when this indicator is
ashing green.
On/O button
Press this button to
turn on or turn o
the device.
Safe to Touch Icon/
Action Arrows
You may touch the
patient when the action
arrows around this icon
are ashing.
Speaker
Listen for the
metronome and
verbal prompts.
Adult and
Pediatric Symbols
Indicates that the
SAM 450P is compatible
with both the Pad-Pak
and Pediatric-Pak.
Do Not Touch Icon/
Action Arrows
Do not touch the
patient when the
action arrows above
this icon are ashing.
The SAM 450P may
be analyzing the
patient’s heart rhythm
or about to charge, in
preparation to deliver
a shock.
Shock Button
Press this button to deliver
a therapeutic shock.
CPR Rate Advisor Icon
Provides visual feedback
about the rate of chest
compressions during CPR.
Data Port
Plug the custom USB cable
into this port to download
event data from the AED.
(See Figure 8, page 24.)
Pad-Pak
Contains the battery
and electrode pads.
Green Tab
Pull this tab to release
the electrodes.
Attach Pads Icon/Action Arrows
Attach the electrode pads to the
patient’s bare chest as indicated
when the action arrows are ashing.
SAM 450P Layout
Introduction continued

Unpacking
Verify that the contents include the samaritan
PAD, carry case, Pad-Pak, User Manual, Warranty
Statement and Warranty Card.
Pad-Pak
A Pad-Pak is a single-use removable cartridge that
includes the battery and electrode pads in a single
unit. The Pad-Pak is available in two versions:
1. Pad-Pak (gray color shown in Figure 1) for use on
patients weighing over 55 lb/25 kg, or equivalent
to a child of approximately eight years of age
or older.
2. The optional Pediatric-Pak (pink color shown in
Figure 2) for use on smaller children (from 1 to 8
years old and weighing under 55 lb/25 kg).
WARNING: Do not delay treatment trying to
determine the patient’s exact age and weight.
Set-up
Figure 2. Pediatric-Pak
Figure 1. Adult Pad-Pak
1 The Pad-Pak also is available in a TSO-certied version for
use on aircra.
SETUP
13

14
Putting the samaritan PAD into Service
Follow these steps to place your samaritan PAD into
service:
1. Check the expiration date (year-month-day)
on the rear of the Pad-Pak (see Figure 3). If the
expiration date has passed, do not use and
immediately replace the expired Pad-Pak.
Figure 3. Expiration Date
2. Unpack the Pad-Pak and retain the packaging
in case you need to return the Pad-Pak to
HeartSine Technologies.
3. Place the samaritan PAD face up on a at surface
and slide the Pad-Pak into the samaritan PAD
(see Figure 4) until you hear the “double click” to
indicate that the tabs on the right and le sides
of the Pad-Pak are fully engaged.
Figure 4. Inserting a Pad-Pak
4. Verify that the green Status indicator (see the
layout for your model on pages 10-12) is blinking
to indicate the initial self-test routine has been
performed and the device is ready
for use.
5. Press the On/O Button to turn on the
samaritan PAD. Listen for, but do not follow,
the voice prompts to ensure that no warning
messages are played.
PRECAUTION: Do NOT pull the green tab on
the Pad-Pak at this time. If you have pulled the tab
and opened the electrode drawer, you may need to
replace your Pad-Pak.
Only turn on the samaritan PAD ONCE. If you turn it
on and o repeatedly, you will deplete the batteries
prematurely and may need to replace the Pad-Pak.
Set-up continued

6. Press the On/O Button to turn o the
samaritan PAD. Verify that the Status Indicator is
ashing green. If you have not heard a warning
message and the Status Indicator continues to
ash green, the device is ready for use.
7. Place the samaritan PAD in its supplied so
carry case. Store the samaritan PAD where it
will be seen and heard in an unobstructed,
secure location in a clean, dry environment.
Be sure to store the device according to the
environmental specications (see Technical
Data in Appendix C on page C-1).
PRECAUTION: HeartSine Technologies
recommends that you store a spare Pad-Pak with
your samaritan PAD in the rear section of the so
carry case.
8. Register online, or complete the Warranty Card
and return it to your Authorized Distributor or
HeartSine Technologies directly (see Tracking
Requirements on page 26).
9. Create a service schedule (see Service and
Maintenance on page 27).
Preparation Checklist
Following is a checklist of the steps required to set
up your samaritan PAD:
 Step 1. Check the Pad-Pak expiration date.
 Step 2. Install the Pad-Pak and check for a
green status indicator.
 Step 3. Turn on the samaritan PAD to check
operation.
 Step 4. Turn o the samaritan PAD.
 Step 5. Store the samaritan PAD in a
clean, dry environment at
32°F to 122°F/0°C to 50°C.
 Step 6. Register your samaritan PAD.
 Step 7. Create a service schedule.
(See Service and Maintenance on
page 27.)
SETUP
15

16
Using the samaritan PAD
Follow these steps to use your AED, which will
provide you with step-by-step voice prompts.
For a full list of voice prompts for your device see
Voice Prompts in Appendix D.
PRECAUTION: Once a non-shockable rhythm
is detected, the samaritan PAD will end its ready
to shock condition if it had previously decided to
shock.
1. If necessary, move the patient to a safe location,
or remove any source of danger.
PRECAUTION: You must use the samaritan
PAD at least 6 feet/2 meters from all radio
frequency devices, or switch o any equipment
causing electromagnetic interference.
2. If the patient is non-responsive, shake the
patient by the shoulders while speaking loudly.
If the patient becomes responsive, do not use
the AED.
3. Check that the patient’s airway is not blocked,
using a head-chin tilt if necessary.
Using the samaritan PAD
REMOVE
DANGER
CHECK
FOR A
RESPONSE
CHECK
FOR
AIRWAY

4. Call for medical assistance.
5. Retrieve the AED, asking others nearby to do so.
6. While waiting for the AED, begin CPR, pushing
hard and fast at a rate of between 100 and 120
compressions per minute (cpm) and a depth of
5 to 6 cm. If you feel able to give rescue breaths
perform 30 compressions followed by two
rescue breaths.
7. Press the On/O Button to turn on the AED.
8. Debrillation therapy is tailored depending on
whether a Pad-Pak or Pediatric-Pak is installed. If
the patient is under 55 lb/25 kg or 8 years of age,
remove the Pad-Pak, insert a Pediatric-Pak and
press the On/O button again (see Pediatric-Pak
on page 21). If a Pediatric-Pak is not available,
you may use the Pad-Pak.
PERFORM
CPR
TURN ON
THE AED
USING THE samaritan PAD
17

18
Using the samaritan PAD continued
BARE THE
CHEST
AREA
OPEN
THE
ELECTRODE
POUCH
9. Remove clothing from patient’s chest to expose
bare skin, removing any metal (bras or jewelry)
where possible from the pad placement area.
10. Dry the patient’s chest if wet or clammy, and if
a lot of chest hair is present, shave the patient’s
chest where the electrodes will be placed.
11. Pull the green tab to remove the electrode pad
pouch from the AED.
12. Tear open the pouch to remove the electrode pads.