AED CellAED User manual

SINGLE-USE AED 2
USER MANUAL
PEELSNAP STICK
SINGLE-USE AUTOMATED EXTERNAL DEFIBRILLATOR
Read the User Manual carefully before using the
CellAED® and keep it for future reference.

2
TABLE OF CONTENTS
01 OPERATING INSTRUCTION
MANUAL INFORMATION 4
1.1 Notice 4
1.2 Software license statement 4
1.3 Regarding this manual 5
1.4 Limits to manufacturer’s responsibilities 5
1.5 Indemnification 5
1.6 Compliance with local regulations 5
02 GLOSSARY 6
03 SYMBOLS USED IN THIS MANUAL / DEVICE 8
04 SAFETY INFORMATION 15
4.1 Responsibility of user and training
requirements 15
4.2 CellAED® intended use 15
4.2.1 What is sudden cardiac arrest? 15
4.3 CellAED® indications for use 16
4.4 Contraindications 16
4.5 Safety terms 16
4.6 Operation with other devices 16
4.7 Terms of Warranty 17
4.8 More Information 17
05 ABOUT CellAED® 18
5.1 The CellAED® 18
5.2 Capabilities and key features 18
5.2.1 Accessories 18
5.2.2 Simple Snap…Peel…Stick® operation 18
5.2.3 Automated operation 18
5.2.4 Continuous battery diagnostic 19
5.2.5 Heart rhythm analysis 19
5.2.6 Defibrillation waveform 19
5.2.7 Shelf Life 19
06 SHELF LIFE 20
6.1 Unpacking and inspecting the CellAED® 20
6.2 Packaging, instructions, controls, indicators
and labels 22
6.3 Storing the CellAED® 28
6.4 Maintaining the CellAED® 28
6.5 Disposing the CellAED® 31
07 HOW TO USE THE CellAED® 32
7.1 Pad placement and chest compression CPR
for patients weighing greater than 10 kg
(22 lbs) 32

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7.2 Pad placement and chest compression
CPR for infants weighing less than 10 kg
(22 lbs) 32
7.3 What happens when I activate
the CellAED® 32
7.4 Responding to a sudden cardiac arrest using
the CellAED® on a patient weighing greater
than 10 kg (22 lbs) 35
Step 1 Assess safety of location 35
Step 2 Determine whether the
patient is in sudden cardiac arrest 35
Step 3 Call emergency services
immediately and retrieve the CellAED® 35
Step 4 Start chest compression CPR 35
Step 5 Prepare the patient for
treatment with the CellAED® 36
Step 6 Remove the CellAED®
from the packaging 37
Step 7 Defibrillate using the CellAED® 37
7.5 Responding to a sudden cardiac arrest using
the CellAED® on an infant weighing less than
10 kg (22 lbs) 40
Step 1 Assess safety of location 40
Step 2 Determine whether the infant
is in sudden cardiac arrest 40
Step 3 Call emergency services
immediately and retrieve the CellAED® 40
Step 4 Start chest compression CPR 40
Step 5 Prepare the Infant for
treatment with the CellAED® 40
Step 6 Remove the CellAED®
from the packaging 41
Step 7 Defibrillate using the CellAED® 42
08 VOICE PROMPT INSTRUCTIONS 44
09 TROUBLESHOOTING 50
10 TECHNICAL SPECIFICATIONS
AND INFORMATION 52
10.1 Technical terminologies / acronyms 52
10.2 Technical characteristics & specifications 53
10.3 Biphasic exponential waveform 56
10.4 ECG interpretation & performance 57
10.5 Guidance & manufacturer’s declaration –
Electromagnetic emissions & immunity 58
10.5.1 Electromagnetic emissions 58
10.5.2 Electromagnetic immunity 59
10.6 Recommended separation distance between
portable and mobile RF communications
equipment and the CellAED® 62
11 DANGERS, WARNINGS & CAUTIONS 64
12 CONTACTS 69

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Read the Operating Instructions carefully before
using the CellAED® and keep it for future reference.
1.1 NOTICE
It is not permitted to reproduce or duplicate this
manual in any part without the permission of RRR
Manufacturing Pty Ltd, hereafter referred to as RRR.
All rights are reserved ©2020.
All images are Copyright Protected©: CellAED® is a
registered trademark of CellAED Life Saver Pty Ltd.
All Trademarks indicated in this document are
owned by CellAED Life Saver Pty Ltd.
Software in this product is copyrighted to RRR or
its vendors. All rights are reserved. The embedded
firmware and software shall not be copied,
decompiled, reverse-engineered, disassembled or
otherwise used in any way, and remain the property
of RRR.
1.2 SOFTWARE LICENSE STATEMENT
STM32 HAL Library is Copyright © ST Micro.
All Rights Reserved. This piece of software is made
available under the terms of the BSD Style license,
which can be found below.
CMSIS Arm Library is Copyright © ARM Limited.
All Rights Reserved. This piece of software is made
available under the terms of the BSD Style license,
which can be found below.
BSD LICENSE
Redistribution and use in source and binary forms,
with or without modification, are permitted provided
that the following conditions are met:
Redistributions of source code must retain the above
copyright notice, this list of conditions and the
following disclaimer.
Redistributions in binary form must reproduce the
above copyright notice, this list of conditions and
the following disclaimer in the documentation and/
or other materials provided with the distribution.
Neither the name of the copyright holder nor the
names of its contributors may be used to endorse
or promote products derived from this software
without specific prior written permission.
THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS
AND CONTRIBUTORS “AS IS” AND ANY EXPRESS OR IMPLIED
WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT
SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE
LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT
NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR
SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS
INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY
OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR
TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN
ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF
ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
For latest Free and Open Source Software
licensing info, please refer to the following URL;
www.rapidresponserevival.com/opensource
For latest company Privacy Policy, please refer to
the following URL;
www.rapidresponserevival.com/legal
01 OPERATING INSTRUCTIONS MANUAL INFORMATION

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1.3 REGARDING THIS MANUAL
The contents of this manual are subject to change
without notice. All efforts have been made to ensure
that the contents of this manual are correct. If for
any reason the user suspects an error, please do not
hesitate to contact RRR at the address shown on
Section 12, page 69.
1.4 LIMITS TO MANUFACTURER’S
RESPONSIBILITIES
RRR Manufacturing Pty Ltd. is not responsible
for the safety and reliability of the CellAED® if
the CellAED® is not used in accordance with all
Instructions and danger, warning and caution notices
in this manual.
1.5 INDEMNIFICATION
RRR Manufacturing Pty Ltd. provides the following
indemnity to persons or legal entities that have
purchased a CellAED® from RRR or an authorized
distributor appointed by RRR (hereafter referred to as
“the Purchaser”).
RRR will, at its cost, defend, indemnify, and hold
harmless the Purchaser from third-party claims or legal
actions for liability or damages resulting from bodily
injury or death caused by a mechanical or electrical
failure of the CellAED®, or the malfunction of the
CellAED® due to a defect in its design or manufacture.
This indemnity does not extend to, or cover, any claim
or legal action for liability or damages in connection
with the use of the Purchaser’s CellAED® caused by:
- Negligent operation of the CellAED®, or failure
to follow the sequential operating instructions for
use of the CellAED®, or:
- Failures or malfunctions of the CellAED® that are
due to improper maintenance, including, without
limitation, malfunctions of electrode pads or
batteries that occur after expiration of their shelf
life, or malfunction of repairs, replacement parts,
pads, or batteries that were not provided by RRR.
This indemnification is expressly conditioned
on the Purchaser’s fulfilling the following
obligations with respect to any claim for which
indemnification will be requested (hereafter
referred to as “the Claim”). The Purchaser will
send it to RRR at the contact address shown
in Section 12, page 69 with written notice of
the Claim, promptly after the Purchaser obtain
knowledge of the Claim.
- The Purchaser also will provide to RRR all assistance
reasonably requested for evaluation of the Claim or
Defense of the Claim. Such assistance will include:
- Transferring possession of the CellAED® involved in
the Claim to RRR (including any electronic records
created by the CellAED® of the event involved in
the Claim) for analysis of the cause of any failure,
and providing to RRR and its counsel all other
evidence relevant to the Claim, whether in the form
of documents or testimony. RRR will promptly
notify the Purchaser in writing if RRR determines
that the Claim is not covered by this indemnity, and
RRR shall have the unrestricted authority to defend
or settle any Claims for which indemnification is
required by this agreement. However, the Purchaser
shall retain the right to participate, at its own
expense, in the defense or settlement of any Claim
that is covered by this indemnity.
All claims in respect of the above must be sent in a timely
manner by registered mail or by electronic mail (email) at
the Contact address in Section 12, page 69.
1.6 COMPLIANCE WITH LOCAL
REGULATIONS
All users must comply with any statutory and local
regulations and requirements associated with ownership
and use of a defibrillator in the region where it is to be
used; check with the Government Health Department
for this information. In case of a difference between the
regulations and these operating instructions, comply
with the regulations in the region of use.

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This document contains some terms that may be unfamiliar. This table includes the terms that you need to be familiar with to use the CellAED®.
TERMINOLOGY / ACRONYMS DESCRIPTION
AED Automated external defibrillator. A device that evaluates the patient’s heart rhythm and delivers an electrical shock to the
heart if a shockable rhythm is detected.
AMA American Medical Association
Agonal breathing Irregular gasping or labored breathing, accompanied by strange vocalizations and involuntary, irregular (lacking rhythm)
muscle spasms that resemble seizures.
Cardiac arrest The termination of the heart’s pumping action, resulting in lack of heartbeat, pulse and/or normal breathing.
CellAED®
The CellAED® is a single-use, portable, transit-operable, fully automated external defibrillator (AED), intended for use by
minimally trained individuals to treat sudden cardiac arrest (SCA), in conjunction with chest compression cardiopulmonary
resuscitation (CPR) until Emergency Services arrive.
CPR Cardiopulmonary resuscitation involves the delivery of chest compressions to a patient in SCA to keep their blood
circulating.
Defibrillation Delivery of an electrical shock to the heart for the purpose of reversing ventricular fibrillation and ventricular tachycardia.
ECG Electrocardiogram. A composite picture of what is occurring electrically in the heart.
02 GLOSSARY

7
EU European Union
Fibrillation Chaotic activity of the heart’s electrical system. This condition can occur in the atria or the ventricles. When it occurs in the
ventricles, they quiver in a rapid, chaotic manner, preventing them from pumping blood to the body.
Heart attack A non-specific term referring to the death of heart muscle tissue resulting from interruption of blood supply, often
confused with cardiac arrest.
LED Light emitting diode
Non-shockable rhythm A heart rhythm that is detected by the CellAED® that does not need a shock, but may need CPR.
Normal sinus rhythm (NSR) The rhythm that originates from the heart’s natural pacemaker and describes the characteristic rhythm of the healthy human
heart. The rate in NSR is generally regular but will vary depending on autonomic inputs into the heart’s natural pacemaker.
Patient In this manual, the person suffering from sudden cardiac arrest.
RRR RRR Manufacturing Pty Ltd
Shockable rhythm A heart rhythm that is detected by the defibrillator as requiring a shock, for example, ventricular fibrillation.
Sudden cardiac arrest (SCA) SCA is usually caused by an electrical malfunction in the heart’s electrical system, which causes the heart to stop pumping
effectively, restricting blood flow to the body.
Ventricular fibrillation (VF) A life-threatening, chaotic heart rhythm originating in the ventricle.
Ventricular tachycardia (VT) A life-threatening, rapid heart rhythm originating in the ventricle.

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SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
Manufacturer
RRR MANUFACTURING PTY LTD
2- 6 Skinner Road Riverwood NSW 2210 AUSTRALIA
ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements)
ISO 7000-3082 — Graphical symbols for use on equipment.
Date of Manufacture
(yyyy-mm-dd)
ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements (5.1.3)
Authorised Representative
in the European Community
Mdi Europa GmbH
Langenhagener Str. 71
D-30855 Langenhagen
ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements (5.1.2)
03 SYMBOLS USED IN THIS MANUAL/DEVICE

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SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
CE marking and Notified
Body Number related to
CE conformity
Hereby, RRR Manufacturing Pty Ltd declares that the CellAED® meets the provision of the following
Union harmonisation legislation: Council Directive 93/42/EEC, Radio Equipment Directive 2014/53/
EU (radio equipment type class 1), RoHS Directive 2011/65/EU. The full text of the EU declaration of
conformity is available at the following internet address: www.rapidresponserevival.com/declaration-
of-conformity
Catalogue or model number
ISO 15223-1, Clause 5.1.6 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied
ISO 7000- 2493 — Graphical symbols for use on equipment
Serial number
ISO 15223-1, Clause 5.1.7 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied.
ISO 7000-2498 — Graphical symbols for use on equipment.
Refer to Operating
Instruction Manual / Booklet ISO 7010-M002 — Refer to instruction manual / booklet
(Continued page 10)

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SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
Caution: Read all warnings
and precautions in
instructions for use. Refer
to the Section about
General Warnings, Alerts
and Cautions for more
information about the
warnings and cautions.
ISO 15223-1, Clause 5.4.4 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied.
IEC 60601-1-11:2015, Table D.1, Symbol 10 Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance.
ISO 7000-0434 — Graphical symbols for use on equipment.
Keep away from sunlight
ISO 7000 — Graphical symbols for use on equipment — Registered symbols.
To indicate that transport package shall not be exposed to sunlight. Reference No:
0624. Registration date: 2014-06-04. Status: Active.
Do not damage Do not damage or crush
Keep away from
high heat Do not expose to high heat or open flame. Do not incinerate.

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SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
Do not open until
ready for use ISO 7010 - Graphical symbols, safety colours and safety signs.
Do not re-use
ISO 15223-1, Clause 5.4.2 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied.
ISO 7000-1051 — Graphical symbols for use on equipment.
Separate collection for
waste of electrical
and electronic equipment
EN 50419 — Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of
Directive 2002/96/EC (WEEE). Recycle: Electronic Equipment DO NOT THROW IN TRASH.
Storage temperature range
Indicates the temperature limits to which the medical device can be safely exposed.
ISO 15223-1, Clause 5.3.7 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied.
ISO 7000-0632 — Graphical symbols for use on equipment.
Storage humidity range
ISO 15223-1, Clause 5.3.8 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied. Indicates the range of humidity to which the medical device can be
safely exposed.
ISO 7000-2620 — Graphical symbols for use on equipment.
15°C
(59°F)
35°C
(95°F)
(Continued page 12)
0%
95%

12
SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
Keep dry
ISO 15223-1, Clause 5.3.4 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied.
ISO 7000-0626 — Graphical symbols for use on equipment.
A potential or actual hazard
exists. Warning, high voltage EN 60601-1-11 : 2015
Type BF applied part IEC 60417. Committee: IEC/SC 3C. Type BF applied part. Reference number: 5333. Type: For use on
equipment.
Consult Instructions for Use
ISO 15223-1, Clause 5.4.3 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied.
IEC 60601-1-11:2015, Table D.1, Symbol 11 Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance.
ISO 7000-1641 — Graphical symbols for use on equipment.
PPatent rapidresponserevival.com/patents
Logo RRR Worldmark Logo

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SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
SNAP
Visually represents the action required to activate the CellAED®. The CellAED® is separated along the
centreline, into two halves. The SNAP simultaneously commences audio (voice) prompts, guiding the
user through the next steps.
PEEL
Visually represents the activation process of the CellAED®. The gel pad liner is removed completely
by separation of the two halves of the CellAED®, exposing the adhesive gel pads and extending the
electrical connecting cable.
STICK Visually represents the activation process of the CellAED®. Audio (voice) prompts instruct the user to
apply the electrode gel pads of the CellAED® to the patient appropriately.
(Enclosure) Protected from
tools & wires greater than 2.5
millimeters & water spray less
than 15 degrees from vertical
A two-digit number established by the International Electro Technical Commission, is used to provide an
Ingress Protection rating to a piece of electronic equipment or to an enclosure for electronic equipment.
The protection class after EN60529 are indicated by short symbols that consist of the two code
letters IP and a code numeral for the amount of the protection.
Class IIb Medical Electrical
Equipment Indicates and refers to the level of electrical isolation provided by the part.
(Continued page 14)

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SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
Electromagnetic
Interference Interference may occur in the vicinity of equipment.
Batch code
ISO 15223-1, Clause 5.1.5 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied.
ISO 7000-2492 — Graphical symbols for use on equipment.
Use-by Date as
yyyy-mm-dd
ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements (5.1.4) Indicates the date after which the
medical device is not to be used.
ISO 7000-2607 — Graphical symbols for use on equipment.
Do not use if package is
damaged
ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements (5.2.8)
Fragile, handle with care
ISO 15223-1, Clause 5.3.1 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied. Indicates a medical device that can be broken or damaged if not
handled carefully. / ISO 7000-0621 — Graphical symbols for use on equipment.

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This Section provides important information to
help you safely operate your CellAED®. Familiarise
yourself with safety terms (Danger, Warning and
Caution) in this Section.
4.1 RESPONSIBILITY OF USER AND
TRAINING REQUIREMENTS
The CellAED® is intended for use by minimally trained
individuals (who have undergone training in the use of
the CellAED®) to treat patients of suspected sudden
cardiac arrest (SCA). It is the responsibility of our
customers to ensure that any person who may use this
CellAED® has access to the information in this manual,
including this Safety Information Section.
Read this manual well before use, and take note of
all instructions, cautions, warnings, dangers, and
statements of intended use. Please ensure that all
potential users are familiar with the intended and
correct use of this product, understand the material
presented in this user manual, and receive appropriate
training for the use of this product. Failure to do so
may result in harm to the patient or user.
All potential users of the CellAED® should read this
User Manual and view the CellAED® Instructional
videos (accessible by scanning the QR code on the
back of the outer packaging (Figure 3B, page 25) and
protective case (Figure 4A, page 26).
Operating instructions include chest compression
cardiopulmonary resuscitation (CPR) guidance for
hand placement, compression depth and timing on
pages 35 - 43.
Do not use the CellAED® to treat any condition other
than SCA. The CellAED® must be used in accordance
with the instructions contained in this User Manual, the
visual cues on the CellAED® and the instructional videos.
RRR assumes no responsibility for any adverse results
arising from improper use of this product.
4.2 CellAED® INTENDED USE
The CellAED® is a single-use, portable, transit-
operable, fully automated external defibrillator (AED),
intended for use by minimally trained individuals to
treat sudden cardiac arrest (SCA) in conjunction with
04 SAFETY INFORMATION
chest compression cardiopulmonary resuscitation
(CPR) until Emergency Services arrive.
4.2.1 WHAT IS SUDDEN
CARDIAC ARREST (SCA)?
SCA is usually caused by an electrical malfunction in
the heart’s electrical system, which causes the heart
to stop pumping effectively, restricting blood flow to
the body. SCA is caused by abnormal heart rhythms
such as ventricular fibrillation (VF) and ventricular
tachycardia (VT). SCA can occur in anyone, from
infants to adults. If not treated immediately, SCA can
lead to death.
In combination with CPR, defibrillation is the most
effective treatment for SCA. The CellAED® is
activated with a simple, three-part SNAP, PEEL,
STICK® action (Figure 5 (b) and (c), page 34). After
the CellAED® electrode pads are placed on the
patient’s exposed chest, the CellAED® analyses the
patient’s heart rhythm. If a shockable rhythm such
as VF or VT is detected, the CellAED® will deliver
an intense pulse of electricity (shock) through the
electrode pads to the heart muscle, to attempt to

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restore the heart’s electrical function to a normal
sinus rhythm (NSR). The CellAED® will then instruct
the user to commence chest compression CPR for 2
minutes. If a shockable heart rhythm is not detected,
the CellAED® will not deliver a shock and will
instruct the user to commence chest compression
CPR. The CellAED® automatically repeats this
process. Once removed from the chest, placing the
two pads together deactivates the CellAED®.
4.3 CellAED® INDICATIONS FOR USE
The CellAED® should be used on patients in SCA
for the treatment of VF and VT. The fully integrated
electrode gel pads can be applied to adults and
children weighing greater than 10 kg (22 lbs) and
infants weighing less than 10 kg (22 lbs).
A person in SCA is:
• Unresponsive,
• Unconscious, and
• Not breathing or not breathing normally
(including agonal breathing).
4.4 CellAED® CONTRAINDICATIONS
The CellAED® must not be used if a person is:
• Responsive,
• Conscious, or
• Breathing normally (with no signs of agonal
breathing)
The CellAED® is not intended for use in the
emergency medical services environment.
4.5 SAFETY TERMS
You may encounter the following terms throughout
this manual and while using the CellAED®:
Danger
Immediate hazards that will result in serious personal
injury or death to the user and/or the patient.
Warning
Hazards or unsafe practices that could result in serious
personal injury or death to the user and/or the patient.
Caution
Hazards or unsafe practices that could result in
minor personal injury to the user and/or the patient,
product damage, or property damage.
Please refer to Section 11, pages 64 - 68.
4.6 OPERATION WITH OTHER DEVICES
The CellAED® may cause interference with other
medical equipment. While the CellAED® complies
with radiated emission standards, some medical
equipment may still be impacted by emissions from
the CellAED®. If this occurs, move the impacted
equipment away from the CellAED® until the
CellAED® is no longer needed for the patient, or
Emergency Services arrive.
DANGER
- User modification of, or interference with, the
mechanical/electrical integrity of the CellAED®
may affect the performance of the CellAED®
and/or the electromagnetic emissions, which could
compromise other equipment in close proximity.
- Using other manufacturers’ cables or electrode
pads may cause the CellAED® to perform improperly
and invalidates the safety agency certification.

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CAUTION
- The normal operation of the CellAED®,
including the ability to correctly detect
a shockable rhythm, may be impacted
if it is operated near strong sources of
electromagnetic interference (EMI) and/or
radio frequency interference (RFI). This can
include arc welders and radio transmitters. If it
is safe to do so, keep a separation between the
CellAED® and strong sources of EMI and RFI of
at least 1.2m (4ft).
4.7 TERMS OF WARRANTY
The CellAED® is warranted against defects
in material and manufacture for the duration
of 13 months (as from date of manufacture).
Excluded from this guarantee is damage caused
by an accident or as a result of mishandling.
The warranty entitles free replacement of the
CellAED®. Any liability for subsequent damage is
excluded. The warranty is void if unauthorised or
unqualified persons attempt to make any repairs or
modifications.
In case of a defect, send the apparatus to your
nearest distributor/dealer or directly to the
manufacturer Section 12, page 69.
4.8 MORE INFORMATION
Contact your local CellAED® Distributor for
additional information about the CellAED®. They will
be happy to answer any questions you may have and
to provide you with copies of the clinical summaries
of several key studies involving the CellAED®.
Technical information about the CellAED® is also
available online at www.rapidresponserevival.com

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The CellAED® conforms to all mandatory clinical
requirements in compliance with EN 60601-2-
4:2011+A1:2019 and EN 60601-1-11:2015.
The unit complies with all relevant standards for
patient’s safety and operating conditions.
5.1 The CellAED®
The CellAED® is shipped ready-to-use with the pre-
programmed CellAED® biphasic energy protocol.
It is a fully automated external defibrillation device
to be used for patients weighing greater than 10
kg (22 lbs) or more, and with infants weighing less
than 10 kg (22 lbs) when the Infant Mode button is
pressed, prior to the arrival of Emergency Services.
When electrode pads are properly applied to the
patient’s exposed chest, the CellAED® automatically
analyses the patient’s heart rhythm. If a shockable
rhythm is detected, the CellAED® automatically
delivers an electrical pulse (shock) to the heart
muscle with the aim of restoring NSR.
The CellAED® will only administer defibrillation
when the heart exhibits VF and VT, as these are the
heart rhythms associated with SCA. The CellAED®
will not administer an electrical shock if it detects a
healthy heart rhythm or abnormal heart rhythms not
associated with SCA, such as NSR, asystole and all
other rhythms (refer to Section 10.4, page 57).
After shock delivery, the CellAED® will re-assess the
patient’s heart rhythm, and continue to instruct the
User and deliver shocks in a timely and appropriate
manner as necessary.
For use with an infant weighing less than 10 kg (22
lbs), the CellAED® requires the user to press the
infant button twice to confirm and enable Infant
Mode.
In both modes there are audio (voice) prompts that
guide the user through the defibrillation process.
For detailed instructions for use, refer to Sections
6 - 8, pages 20 - 49.
05 ABOUT CellAED® 5.2 CAPABILITIES AND KEY FEATURES
The following paragraphs introduce specific key
features found in the CellAED®.
5.2.1 ACCESSORIES
No accessories provided.
5.2.2 SIMPLE SNAP…PEEL…STICK®
OPERATION
CellAED® is designed to enable any operator to
perform defibrillation in the event of a cardiac arrest
with a quick and simple SNAP…PEEL…STICK® action,
as illustrated in Figure 5, page 34, prior to arrival of
Emergency Services.
5.2.3 AUTOMATED OPERATION
The ‘SNAP’ action activates the CellAED®. It will
commence audio (voice) prompt instructions to guide
the defibrillation and chest compression CPR process.
When the CellAED® electrode pads are placed
correctly on the patient, they automatically identify
whether a shockable rhythm is present. If a shockable
rhythm is detected, the CellAED® will commence
charging the capacitors to release a shock.

19
There is an Infant Mode button that the user must press
if the patient is an infant weighing less than 10 kg (22 lbs);
this is a manual action taken when the CellAED®
audio (voice) prompt invites them to “For infants, press
infant button.” The user must press the infant button
a second time to confirm and enable Infant Mode.
The CellAED® will issue audio prompt warnings prior
to shock delivery. Shock delivery is automated by
the CellAED®.
If the patient is transferred to emergency medical
personnel, the medical personnel can remove the
CellAED® electrode pads and replace with their own
defibrillation equipment, if available. The CellAED®
must be removed before any alternative defibrillator
is applied. To deactivate the CellAED®, stick the gel
sides of the electrode pads together for at least five
seconds. Audio (voice) prompts will acknowledge
when the CellAED® has been deactivated. Dispose
of the CellAED® safely and immediately according
to local council regulations.
5.2.4 CONTINUOUS BATTERY DIAGNOSTIC
The CellAED® is constantly aware of the battery status
and provides visual feedback to indicate the state of
readiness.
A blinking GREEN LED (every 30 seconds) indicates
the CellAED® is fully operational and ready to use.
A blinking AMBER LED (every 30 seconds) indicates
that the battery is low and the CellAED® should be
replaced immediately.
No LED indicates that the battery has expired and
the CellAED® should be replaced immediately.
5.2.5 HEART RHYTHM ANALYSIS
The CellAED® evaluates the patient’s heart rhythm.
Refer to Section 10.4, page 57 (ECG Interpretation
and Performance) for further information.
5.2.6 DEFIBRILLATION WAVEFORM
The defibrillation shock, using patented CellAED®
biphasic waveform technology, is a fully-discharging
capacitator method for delivering an energy-
efficient biphasic defibrillation waveform. The
waveform is automatically adjusted to compensate
for patient impedance. The CellAED® does not
detect patient motion.
5.2.7 SHELF LIFE
The CellAED® can be used up to 13 months from
the date of manufacture. This date is printed on the
CellAED® as a Date of Manufacture and indicates
the Use-by Date for the CellAED®.
Maintaining the CellAED® in an ideal storage condition
(15°C – 35°C (59°F – 95°F)) is required to maximise
the performance of the battery as well as the
CellAED® expected shelf life (refer to Section 6.4,
page 28).

20
The CellAED® package contains:
- One CellAED® single-use automated external
defibrillator
- This is sealed inside a transparent bag and a
protective case – do not open these until the
CellAED® is needed to treat SCA
- Instructions for operating the CellAED®
6.1 UNPACKING & INSPECTING THE
CellAED®
To help ensure the integrity of the CellAED® and to
verify that it is complete and ready for use, perform
the following inspection (Figure 1 - Figure 4B, pages
21 - 27):
1. Inspect the outer packaging for signs of damage
that may have occurred during transport. If the
packaging presents rips, cracks, bends, leakages,
discolorations, or deformation, contact your
nearest distributor.
2. Open the outer packaging and remove the
protective case. Check that the tamper evident
seal (Figure 1 (b), page 21) on the protective case
has not been broken. Do not remove the tamper
evident seal, and do not remove the CellAED®
from the protective case and sealed transparent
bag until required for emergency use (Figure 1 (c)
and (d), page 21).
Do not store the CellAED® in the outer packaging,
as the LED indicating battery life and readiness for
use will not be visible.
3. Check the Date of Manufacture/Use-by Date on
the back side of protective case (Figure 4A, page
26). Confirm that the current date is within 13
months of the manufacturing date. The CellAED®
expires 13 months after manufacture. Verify that
the green LED indicator is blinking. The green
LED will blink every 30 seconds (Figure 5 (e),
page 34)), and is visible through the protective
case (Figure 1 (d), page 21). A green LED blinking
means the CellAED® is ready for use.
4. Save the outer packaging and any inserts in case
the CellAED® requires transporting in the future.
Contact RRR with any questions about the
CellAED® (Section 12, page 69).
CAUTION: Do not open the sealed tamper-proof
and protective packaging of the CellAED® unless
you intend to use the CellAED®. This packaging
protects the CellAED® from accidental activation,
and from environmental elements such as water,
heat and dust. Opening the packaging can expose
the CellAED® to environmental contaminants and
compromise its effectiveness. The CellAED® should
be disposed of safely and immediately according to
local council regulations.
Only open the sealed packaging and activate the
CellAED® prior to immediate use.
Once the unit is unsealed, it should either be used
in an appropriate manner or disposed of safely and
immediately according to local council regulations.
06 GETTING STARTED