CellAED AED 2 100-2.2-094 Automated External Defibrillator User Manual
- June 14, 2024
- CellAED
Table of Contents
AED 2 100-2.2-094 Automated External Defibrillator
Product Information: – Product Name: SINGLE-USE
AED 2 100-2.2-094 – Product Type: Automated External Defibrillator
– Model Number: RMDOC0007v3 Product Usage
Instructions: 1. Operating Instructions Manual
Information – Notice: All trademarks indicated in this
document are owned by CellAED Life Saver Pty Ltd. – Software
License Statement: The software in this product is copyrighted to
RRR or its vendors. It shall not be copied, decompiled,
reverse-engineered, disassembled, or used in any way without
permission. 2. Operating Instructions – Read the
operating instructions carefully before using the product. – Ensure
compliance with local regulations. – The manufacturer’s
responsibility is limited. – Indemnification may be required. 3.
Safety Information – The user is responsible for
the proper usage and training requirements. – Pad placement and
chest compression CPR instructions are provided for patients
weighing greater than 10 kg (22 lbs) and infants weighing less than
10 kg (22 lbs). – Assess the safety of the location before
responding to a sudden cardiac arrest. 4. Getting
Started – The packaging includes instructions, controls,
indicators, and labels. – Follow the steps mentioned below to
respond to a sudden cardiac arrest: – Step 1: Assess the safety of
the location. – Step 2: Determine whether the patient is in sudden
cardiac arrest. – Step 3: Activate the AED if required. – Step 4:
Start chest compression CPR. – Step 5: Prepare the patient for
defibrillation. – Step 6: Remove the AED from the packaging. 5.
Voice Prompt Instructions – Detailed voice prompt
instructions are provided for proper usage. Refer to section 08 for
more information. 6. Troubleshooting – Section 09
provides troubleshooting information in case of any issues with the
product. 7. Technical Specifications and
Information – Technical terminologies, characteristics,
and specifications are provided in section 10. – Information
regarding the biphasic exponential waveform, ECG interpretation,
and electromagnetic emissions is included. 8. Dangers,
Warnings & Cautions – Section 11 highlights potential
dangers, warnings, and cautions associated with the product. 9.
Contacts – Section 12 provides contact information
for further assistance. Please refer to the user manual for
complete details and instructions on using the SINGLE-USE AED 2
100-2.2-094.
SINGLE-USE AED 2 100-2.2-094
USER MANUAL
AUTOMATED EXTERNAL DEFIBRILLATOR
Read the User Manual carefully before using the CellAED® and keep it for
future reference
SNAP PEEL STICK
RMDOC0007v3
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
4.2 CellAED® intended use 4.2.1 What is sudden cardiac arrest?
4.3 CellAED® indications for use 4.4 Contraindications 4.5 Safety terms 4.6
Operation with other devices 4.7 Warranty 4.8 More Information
15
5.2.5 Heart rhythm analysis
19
15
5.2.6 Defibrillation waveform
19
16
5.2.7 Use-by Date
19
16
16 06 GETTING STARTED
20
16
6.1 Unpacking and inspecting the CellAED® 20
17
6.2 Packaging, instructions, controls, indicators
17
and labels
22
6.3 Storing the CellAED®
28
02 GLOSSARY
6 05 ABOUT CellAED®
18
6.4 Maintaining the CellAED®
28
5.1 The CellAED®
18
6.5 Disposing of the CellAED®
31
03 SYMBOLS USED IN THIS MANUAL / DEVICE 8
5.2 Capabilities and key features
18
5.2.1 Accessories
18 07 HOW TO USE THE CellAED®
32
04 SAFETY INFORMATION 4.1 Responsibility of user and training requirements
15
5.2.2 Simple Snap Peel StickTM operation 18
7.1 Pad placement and chest compression CPR
5.2.3 Automated operation
18
15
5.2.4 Continuous battery diagnostic
19
for patients weighing greater than 10 kg
(22 lbs)
32
2
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
3
01
OPERATING INSTRUCTIONS MANUAL INFORMATION
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 ©2023.
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; cellaed.info/open-source
For latest company Privacy Policy, please refer to the following URL;
cellaed.info/privacy-policy
4
1.3 REGARDING THIS MANUAL
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
To the maximum extent permitted by law, 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 an authorized distributor, or RRR at the contact address shown in
Section 12, page 69 with written notice of the Claim, promptly after the
Purchaser obtains 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 and/or
distributor (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) to an authorized distributor or
the manufacturer 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.
5
02 GLOSSARY
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 Asystole
Irregular gasping or labored breathing, accompanied by strange vocalizations
and involuntary, irregular (lacking rhythm) muscle spasms that resemble
seizures.
Asystole is the state characterised by a lack of heart rhythm, commonly known
as flatlining. It occurs when the heart has stopped beating and there is no
electrical activity in the heart.
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 Defibrillation
Cardiopulmonary resuscitation involves the delivery of chest compressions to a
patient in SCA to keep their blood circulating.
Delivery of an electrical shock to the heart for the purpose of reversing
ventricular fibrillation and ventricular tachycardia.
6
ECG Fibrillation
Heart attack LED Non-shockable rhythm Normal sinus rhythm (NSR) Patient RRR
Shockable rhythm Sudden cardiac arrest (SCA) Ventricular fibrillation (VF)
Ventricular tachycardia (VT)
Electrocardiogram. A composite picture of what is occurring electrically in
the heart. 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. A non-specific term referring to the death of heart muscle tissue
resulting from interruption of blood supply, often confused with cardiac
arrest. Light emitting diode
A heart rhythm that is detected by the CellAED® that does not need a shock,
but may need CPR. 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. In this manual, the person
suffering from sudden cardiac arrest.
RRR Manufacturing Pty Ltd
A heart rhythm that is detected by the defibrillator as requiring a shock, for
example, ventricular fibrillation. A sudden cardiac arrest occurs when the
heart stops pumping blood. It can be caused by an electrical or mechanical
problem with the heart. A life-threatening, chaotic heart rhythm originating
in the ventricle.
A life-threatening, rapid heart rhythm originating in the ventricle.
7
03 SYMBOLS USED IN THIS MANUAL/DEVICE
SYMBOLS
DESCRIPTION
Manufacturer
Date of Manufacture (yyyy-mm-dd)
RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
ISO 15223-1 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.
ISO 15223-1 Medical devices — Symbols to be used with medical device labels,
labelling and information to be supplied — Part 1: General requirements
(5.1.3)
Automated External Defibrillator
AS 1319-1994 Emergency Information Signs. Emergency Signs indicate the location of life saving equipment.
Authorised Representative ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and in the European Community information to be supplied Part 1: General requirements (5.1.2)
UKCA mark related to The Medical Devices Regulations 2002 (UK)
The Medical Devices Regulations 2002 (UK); Products with the mark indicates conformity with the applicable requirements in The Medical Devices Regulations 2002 (UK) have been verified and are able for commercial supply within Great Britain.
8
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, WEEE Directive 2012/19/EU. The full text of the EU declaration of conformity is available at the following internet address: cellaed.info/declaration-of-conformity
Regulatory Compliance Mark related to electrical
safety and EMC requirements
Hereby, RRR Manufacturing Pty Ltd declares that the CellAED® meets the AS/NZS 4417.1:2012 Regulatory Compliance Mark for Electrical and Electronics Equipment Use of the Mark.
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) 9
SYMBOLS 10
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.
SYMBOLS
DESCRIPTION
RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
15°C (59°F)
0%
35°C (95°F)
95%
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.
(Continued page 12) 11
SYMBOLS
P 12
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.
Patent
rapidresponserevival.com/legal
Logo
RRR Worldmark Logo
SYMBOLS
DESCRIPTION SNAP PEEL
RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
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.
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 Electrotechnical
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 EN 60529 are indicated by short symbols that
consist of the two code letters IP and a code numeral for the amount of the
protection.
(Continued page 14) 13
SYMBOLS 14
DESCRIPTION
RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION
Electromagnetic Interference
Interference may occur in the vicinity of equipment.
Batch code
Use-by Date as yyyy-mm-dd
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.
ISO 15223-1 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 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.
04 SAFETY INFORMATION
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. 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. Online
access to a PDF of the User Manual and step-by-step video instructions are
accessible by scanning the QR codes 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.
To the maximum extent permitted by law, 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, transitoperable, 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.
4.2.1 WHAT IS SUDDEN CARDIAC ARREST (SCA)?
A sudden cardiac arrest occurs when the heart stops pumping blood. It can be
caused by an electrical or mechanical problem with the heart. 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 StickTM
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 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
15
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 patients 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).
Always consult a Healthcare Professional for any health concerns (e.g. chest
pain). The CellAED® is intended to treat SCA only.
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. The CellAED® is not intended for use on injured skin.
4.5 SAFETY TERMS
You may encounter the following terms throughout this manual and while using
the CellAED®: Danger Hazards that could result in immediate 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.
16
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 2 years from date of manufacture, or until Use-by Date, whichever
occurs first.
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.
For Australian consumers, our goods come with guarantees that cannot be
excluded under the Australian Consumer Law. You are entitled to a replacement
or refund for a major failure and compensation for any other reasonably
foreseeable loss or damage. You are also entitled to have the goods repaired
or replaced if the goods fail to be of acceptable quality and the failure does
not amount to a major failure.
For New Zealand consumers, this warranty in no way limits or affects any
rights you may have under the NZ Consumer Guarantees Act.
For United Kingdom customers, this warranty does not affect your statutory
rights.
In case of a defect, cease using the CellAED® and contact the manufacturer at
the contact address shown in Section 12, page 69. In the event of a warranty
claim being made, RRR and the Purchaser will each bear their own expenses in
relation to the preparation and assessment of any warranty claim.
4.8 MORE INFORMATION
Contact the manufacturer 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
cellaed.info/technical-specs
17
05 ABOUT CellAED®
The CellAED® conforms to all mandatory clinical requirements in compliance
with EN 60601-24:2011+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 preprogrammed 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, such
as NSR, or abnormal heart rhythms not associated with SCA, such as asystole
and all other arrhythmias (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 mode 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.
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 STICKTM OPERATION
CellAED® is designed to enable minimally trained individuals to perform
defibrillation in the event of a cardiac arrest with a quick and simple Snap
Peel StickTM 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.
18
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.
Contact the manufacturer for a replacement and instructions to dispose of the
CellAED®.
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 periodic flashing GREEN LED
(every 30 seconds) indicates the CellAED® is fully operational and ready to
use.
A periodic flashing AMBER LED (every 30 seconds) indicates that the battery is
low and the CellAED® should be replaced immediately. Contact the manufacturer
for a replacement.
No LED indicates that the battery has expired and the CellAED® should be
replaced immediately. Contact the manufacturer for a replacement and
instructions to dispose of the CellAED®.
5.2.5 HEART RHYTHM ANALYSIS
The CellAED® evaluates the patient’s heart rhythm. Refer to Section 10.4, page
57 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
energyefficient biphasic defibrillation waveform. The waveform is
automatically adjusted to compensate for patient impedance. The CellAED® does
not detect patient motion.
5.2.7 USE-BY DATE
Your CellAED® has an expiry date, after which it should be replaced. Please
refer to the Use-by Date that is printed on the back of the protective case
(Figure 4A (c), page 26).
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).
19
06 GETTING STARTED
The CellAED® package contains:
– One CellAED® single-use automated external defibrillator 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® – A Monthly Product Inspection
Checklist
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 the
manufacturer.
2. Open the outer packaging and remove the CellAED® in its 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). If the tamper
evident seal has been broken, contact the manufacturer.
Do not store the CellAED® in the outer packaging, as the LED indicator and
expiry date will not be visible.
3. Check and confirm the Use-by Date on the
protective case has not expired (Figure 4A (c),
page 26). Verify that the green LED indicator is
flashing. The green LED will flash approx. every
30 seconds (Figure 5 (e), page 34), and is visible
through the protective case (Figure 1 (d), page 21). A green LED flashing
means the CellAED® is
ready for use. If the CellAED® has expired or the green LED is not blinking,
contact the manufacturer. 4. Save the outer packaging and any inserts in case
the CellAED® requires transporting in the future.
Contact the manufacturer with any questions about the CellAED®.
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.
CAUTION: Only open the sealed packaging and activate the CellAED® prior to
immediate use.
CAUTION: Once the unit is unsealed, the CellAED® must either be used in an
appropriate manner or disposed of as per instructions from the manufacturer.
20
(a) CellAED® (c) Protective
case
(b) Tamper evident seal
FIGURE 1B: Opening the tamper seal
(d) Sealed transparent bag
FIGURE 1: CellAED® protective case front Images are representative only and
may vary between regions
(e) Operational instructions
(Continued page 22) 21
6.2 PACKAGING, INSTRUCTIONS, CONTROLS, INDICATORS AND LABELS
This Section introduces the packaging, instructions, controls, indicators, and
labels of the CellAED®.
LABELS, INSTRUCTIONS AND WARNINGS
The outer packaging box (Figure 3B, page 25) and protective case (Figure 4A,
page 26) feature storage and handling instructions, warnings, and the Date of
Manufacture/ Use-by Date of the CellAED® on the back. QR codes (Figure 3B,
page 25 and Figure 4A (b), page 26) provide online access to a PDF of the User
Manual, and step-by-step video instructions for responding to a patient in
SCA.
CellAED® PROTECTIVE CASE
For personal, home, public, or office use, the CellAED® is stored inside a
hard protective case (Figure 1 (c), page 21). The back of the case details
additional environmental and operational safety requirements, and features a
tamper evident seal (Figure 1 (b), page 21). The CellAED® operational label
(as seen through the transparent bag and front of the transparent protective
case) provides clear
and simple operational instructions to follow when a patient has suspected SCA
(Figure 1 (e), page 21).
Do not open this case until the CellAED® needs to be used to treat SCA.
The CellAED® is sealed in a transparent bag with `Tear here’ tabs (Figure 2B,
page 23). These should only be torn open when the CellAED® will be used.
Each CellAED® has a unique Serial Number (SN) (Figure 5 (g), page 34). Each
CellAED® also has a Unique Device Identification number (UDI) (Figure 4A (a),
page 26). The UDI is the combination of the Global Trade Item Number (GTIN),
the manufacturing date, the expiry date, the batch number and the unique
serial number. These identification numbers are located beside (01), (11),
(17), (10), and (21), respectively.
22
FIGURE 2A: CellAED® sealed transparent bag front Images are representative only and may vary between regions
N/A
AU
Sponsor RRR Manufacturing NZ Limited C/- Nightingale Associated Ltd. Level 2,
347 Parnell Road Parnell, Auckland 1052 NZ
Do not re-use Refer to Operating Instruction Manual/Booklet rapidresponserevival.com/patents REF CA-22d-EN-00-1
15oC (59oF)
0%
35oC (95oF)
15-35oC/59-95oF
95% 0-95%
FIGURE 2B: CellAED® sealed transparent bag back
23 10-NZv0
SSIINNGGLLEE–UUSSEEAAEEDD 22
AUTOMATED EXTERNAL DEFIBRILLATOR
AUTOMATED EXTERNAL DEFIBRILLATOR
Warning: Always consult a Healthcare Professional for any health concerns
(e.g. chest pain). CellAED® is an automated external defibrillator for
emergency use during sudden cardiac arrest only.
TTMM
SNAP PEEL STICK
FIGURE 3A: CellAED® outer packaging front
Images are representative only and may vary between regions 24
Sponsor RRR Manufacturing NZ Limited C/- Nightingale Associated Ltd. Level 2, 347 Parnell Road Parnell, Auckland 1052 NZ
CA-22d-EN-00-1
FIGURE 3B: CellAED® outer packaging back Images are representative only and may vary between regions
QR codes 25
FIGURE 4A: CellAED® protective case back & side
Images are representative only and may vary between regions 26
(a) UDI Label
(b) QR codes (c) Date of Manufacture
and Use-by Date
FIGURE 4B: CellAED® protective case inside
Images are representative only and may vary between regions 27
6.3 STORING THE CellAED®
CAUTION: Store the CellAED® out of reach of pets or children.
Store the CellAED® in its protective case in a location that is visible, easy
to access, easy to remember, has good cellular connectivity and is free of
obstacles. Avoid storing the CellAED® in areas that will expose the CellAED®
to moisture, dust, or extreme temperatures. Consider locating the CellAED®
near other emergency equipment, such as fire extinguishers and first-aid kits.
Position the CellAED® so that the LED Indicator (Figure 5 (e), page 34) on the
front of the CellAED® is easy to see.
DANGER: Do not store or use the CellAED® near flammable gases (such as in an
oxygen-enriched atmosphere) or in direct contact with flammable material.
Store in a dry location away from any heat sources (including direct
sunlight). Turn off local gas sources or move source away from patient during
defibrillation. Failure to comply with any of these conditions presents a risk
of explosion.
Although the CellAED® and electrodes are designed to withstand a range of
temperatures, it is important to follow the recommended storage temperature as
28
described in this manual. Failure to do so may result in damage to the
CellAED® and improper operation.
WARNING: Extreme and fluctuating temperatures will reduce the life of the
battery and electrodes contained within the CellAED®.
The CellAED® should be stored between 15° – 35°C (59° – 95°F). Temperatures
exceeding 35°C (95°F) can permanently damage the internal battery.
6.4 MAINTAINING THE CellAED®
The CellAED® does not require routine maintenance.
Plan a monthly inspection of the CellAED® to:
1. Check the current date is within the CellAED® Use-by Date. If this date
has passed, contact the manufacturer for a replacement and instructions to
dispose of the CellAED®.
2. Check the CellAED® packaging is in good condition; If damage, rips,
cracks, discoloration, or foreign substances (e.g. oil, dirt or dust) are
present, or if the tamper evident seal is compromised, contact the
manufacturer for a replacement and instructions to dispose of the CellAED®.
DANGER: Never use a compromised, damaged, expired, or pre-used CellAED®, as
doing so may
result in ineffective treatment or user injury.
DANGER: The CellAED® is a single-use device and cannot be re-used or recycled.
If the packaging has been broken or damaged in any way, contact the
manufacturer.
3. Observe the LED Indicator on the front of the CellAED® (Figure 5 (e), page
34):
– A periodic flashing GREEN LED (every 30 seconds) indicates that the CellAED®
is fully operational and ready to use.
– A periodic flashing AMBER LED (every 30 seconds) indicates that the battery
is low and the CellAED® should be replaced immediately. Contact the
manufacturer for a replacement.
– NO LED indicates that the battery has expired and the CellAED® must be
replaced immediately. Contact the manufacturer for a replacement and
instructions to dispose of the CellAED®.
WARNING: Colourblind users may have difficulty differentiating between the
GREEN and AMBER LEDs. Please seek assistance and be aware of the product’s
shelf life.
It is strongly recommended that useful items supporting the use of the
CellAED® (towel, safety razor, and scissors) can be easily accessed.
Document your assessment in the Monthly Product Inspection Checklist included with the CellAED®:
HAVE YOU DONE YOUR 3 CHECKS?
Serial Number:
Use-by Date*:
/
/
SAMPLE To complete the below checklist, simply start with present month and year and continue to check monthly until you reach the Use-by Date month.
YEAR
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
20____
20____
20____
Dec
20____
*CellAED® is a single-use, disposable product. Users must be aware of the Use-by Date to ensure your CellAED® is ready for use in an emergency situation. Highlight the month of expiry in the
checklist with an asterisk.
29
DANGER: Damaged or expired equipment may result in ineffective treatment, or
user injury.
The CellAED® may be damaged by mechanical or physical abuse, such as immersion
in water or dropping the CellAED®. Avoid spilling any fluids on the CellAED®
enclosure or its electrode pads. Do not clean with ketones or other flammable
agents. In case of physical or mechanical abuse, contact the manufacturer for
a replacement and instructions to dispose of the CellAED®.
Do not attempt to service or modify the CellAED®. The CellAED® is not intended
for maintenance or service by the user. Modification will void all warranties
and present a serious risk of harm to the user and/or patient.
Maintaining ideal standby/storage environmental conditions (15° – 35°C (59° –
95°F)) is crucial to optimise the performance and maximise the shelf life of
the CellAED®. Certain critical components, such as the battery and the
electrode gel, can be influenced significantly by environmental conditions
outside of the specifications of the CellAED®.
The CellAED® battery is non-rechargeable. As with all batteries, this battery
will decay over time due to its natural self-discharge. Exposure to
temperatures
outside of the specifications of the CellAED® may permanently increase the
self-discharge rate of the battery, which can ultimately lead to a significant
reduction in the expected shelf life of the battery and the CellAED®
accordingly.
Users are strongly encouraged to perform a regular inspection of their
CellAED® and maintain a record. An example of an inspection record is also
provided on page 29.
30
6.5 DISPOSING OF THE CellAED®
The CellAED® is designed to be single use and then disposed of as per the
instructions from the manufacturer.
The CellAED® is non-rechargeable. When the battery is low, the LED will flash
AMBER to indicate the need to replace the CellAED®. Contact the manufacturer
for a replacement and instructions to dispose of the CellAED®.
DANGER: The CellAED® battery is not rechargeable. Do not attempt to recharge,
open, crush, or burn the battery, as these actions present a risk of explosion
or fire and can cause harm to the user. If the battery is depleted, the
CellAED® needs to be replaced. Contact the manufacturer for a replacement and
instructions to dispose of the CellAED®.
expired, is damaged, or you have doubts about the condition of the CellAED®,
contact the manufacturer, who will provide instructions for the disposal of
the CellAED®. Correct disposal procedure must be observed to ensure that no
dangerous substances are released, which may adversely impact human and/or
environmental health.
Return the CellAED® to an authorized distributor or the manufacturer to ensure
that the correct disposal procedure is implemented.
WARRANTY: The Manufacturer provides a Warranty for the battery. For more
details, please refer to Section 4.7 (Terms of Warranty, page 17).
DANGER: Keep a snapped CellAED® out of the reach of children, as the cable presents a risk of strangulation. After use, contact the manufacturer for a replacement and instructions to dispose of the CellAED®.
CAUTION: After the CellAED® has been used, is
31
07 HOW TO USE THE CellAED®
The CellAED® is designed to enable minimally trained individuals to perform
defibrillation in the event of SCA, prior to arrival of Emergency Services.
The use of the CellAED® involves a three-step process, as illustrated in
Figure 5 (page 34):
1. SNAP – Snap the CellAED® to activate it.
2. PEEL – The user must peel the protective liner from the electrode gel
pads.
3. STICK – The user places the electrode gel pads firmly on the patient.
The CellAED® can be used on patients weighing greater than 10 kg (22 lbs) and
infants weighing less than 10 kg (22 lbs) (typically less than 1 year old).
The electrode pads must be positioned appropriately (refer to Section 7.1 and
7.2, page 32). For infants weighing less than 10 kg (22 lbs), the CellAED®
will deliver an adjusted treatment during defibrillation.
DANGER: The CellAED® has a differentiated use for infants weighing less than
10 kg (22 lbs). You must use the Infant Mode on infants weighing less than 10
kg (22 lbs). Failure to do so may result in ineffective
treatment. Activate the CellAED® Infant Mode by pressing the Infant Mode
Button when prompted by the audio (voice) prompts (Figure 5 (d), page 34) only
for infants that weigh less than 10 kg (22 lbs), or typically less than 1 year
old.
CAUTION: If an infant’s age or weight is unknown, make a reasonable
estimation. The World Health Organisation advises that an average 12-month (1
year) old infant weighs 10 kg (22 lbs), meaning that an infant younger than 1
year old can be assumed to be less than 10 kg (22 lbs) in weight.
7.1 PAD PLACEMENT AND CHEST COMPRESSION CPR DELIVERY FOR PATIENTS WEIGHING
GREATER THAN 10 kg (22 lbs)
Both electrode pads are placed on exposed skin on the front of the patient.
STICK one pad firmly onto the patient’s exposed skin just below their right
collar bone, above the breast. STICK the other pad onto the patient’s exposed
skin on their left side, below or under the breast (Figure 9B, page 37).
Chest compressions are delivered between shocks, with both hands placed on top
of each other over the sternum (center of the chest) and are used to deliver
chest compressions to a depth of no more than one third of the patient’s chest
cavity.
7.2 PAD PLACEMENT AND CHEST COMPRESSION CPR FOR INFANTS WEIGHING LESS THAN 10
kg (22 lbs)
For infants less than 10 kg (22 lbs), one of the CellAED® electrode gel pads
is placed on the front of the chest between the nipples, and the other in the
centre of the back (Figure 14, page 42). For infants weighing less than 10 kg
(22 lbs), remove the front chest pad, if applied, before delivering chest
compressions. Chest compressions are delivered with two (2) fingers over the
sternum (center of the chest) (refer to Figure 12, page 41) in between shocks.
This is to control the pressure applied; the user must deliver chest
compressions to a depth of no more than one third of the infant’s chest
cavity.
32
7.3 WHAT HAPPENS WHEN I ACTIVATE THE CellAED®?
The CellAED® label provides images that represent cues for action (Figure 5,
page 34).
i) The series of images at the top demonstrates the CellAED® Snap Peel StickTM
actions for a patient weighing greater than 10 kg (22 lbs). The series of
images at the bottom demonstrates the CellAED® Snap Peel StickTM actions for
an infant weighing less than 10 kg (22 lbs).
ii) Once the CellAED® has been snapped apart into two parts along the
perforated Label Mark for snapping (Figure 5 (a), page 34), the audio (voice)
prompts are activated to guide the user.
iii) The audio (voice) prompts instruct the user to apply the electrode pads
for a patient weighing greater than 10 kg (22 lbs) or for an infant weighing
less than 10 kg (22 lbs) (Figure 5 (b) and (c), page 34). Peeling the lining
from the bottom of the electrode pads enables the pads to be applied to the
patient’s skin.
iv) If the patient weighs less than 10 kg (22 lbs), press the infant button
(Figure 5 (d), page
- when prompted. Press the infant button a second time to confirm and enable
Infant Mode when prompted.
v) If a shockable rhythm is detected, the CellAED® will start charging the electrodes for defibrillation. The red LED will turn on to indicate the CellAED® is charging, and the audio (voice) prompts notify the user not to touch the patient and to stand clear of the patient.
vi) The CellAED® uses audio (voice) prompts to advise the user when to perform chest compression CPR in between shocks, emits a metronome to guide the chest compression rate, and advises the user when to discontinue chest compression CPR. Section 8, pages 44 – 49, describes the audio (voice) prompt instructions and provides a step-by-step reference to using the CellAED®.
vii) The CellAED® defibrillation and audio (voice) prompt functions can be deactivated by pressing the gel sides of the electrode pads together for at least five seconds (refer to Figures 16A and 16B, pages 46-49).
DANGER: Do not remove the electrode pads from the patient during or after rhythm recognition,
during charging, or while the shock is being delivered. The shocks delivered
by the CellAED® can cause serious harm to user(s) or bystanders if the
instructions are not followed.
WARNING: Do not handle or transport the patient while the CellAED® is attached
to the patient and analysing the heart rhythm, as this can cause incorrect or
delayed diagnosis. Keep the patient as still as possible while the CellAED® is
attached.
WARNING: The CellAED® cannot abort a shock once a shockable rhythm has been
detected. The CellAED® delivers up to 85 Joules of electrical energy with
every electrical pulse (shock).
WARNING: Do not attempt to operate the CellAED® unless thoroughly familiar
with this manual and the functions of all controls, indicators and of the
electrode pads.
WARNING: Do not insert any object into the CellAED®.
WARNING: Do not place the electrode pads together when in use, as this may
deactivate the CellAED® functions including audio (voice) prompts, heart
rhythm detection and classification, capacitor charge and discharge, and
render the CellAED® unusable.
(Continued page 34) 33
(a) Perforated Label Mark for snapping the two Electrode Pads apart during
SNAP…PEEL… STICKTM action
(b) Placement of electrode pads for defibrillation of patients weighing
greater than 10 kg (22 lbs)
(c) Placement of electrode pads for defibrillation of infants weighing less
than 10 kg (22 lbs)
(d) Press button for defibrillation of infants weighing less than 10 kg (22
lbs)
(e) LED indicator
(f)Audio speaker
(g) Serial Number
FIGURE 5: CellAED® enclosure with cues for action
Images are representative only and may vary between regions 34
7.4 RESPONDING TO A SUDDEN CARDIAC ARREST USING THE CellAED® ON A PATIENT WEIGHING GREATER THAN 10 kg (22 lbs)
STEP 1 ASSESS SAFETY OF LOCATION
Ensure that no obvious danger is present, and that the area is safe for you to
provide chest compression CPR and administer the CellAED®.
DANGER: Do not use the CellAED® while the patient is in or is near a pool of water or on any other conductive surface(s). Carefully remove the patient if necessary. Ensure that the patient is dry before using the CellAED®.
STEP 2
DETERMINE WHETHER THE PATIENT IS IN SUDDEN CARDIAC ARREST
A patient in SCA is typically:
· Unconscious, · Unresponsive when you talk to, shout at, touch,
or gently shake them (Figure 6, page 35), and · Not breathing or taking
occasional gasping
breaths, accompanied by strange vocalizations and muscle spasms (agonal
breathing).
Can you hear me? Please talk
to me.
FIGURE 6: Check if the patient is responsive
STEP 3
CALL EMERGENCY SERVICES IMMEDIATELY AND RETRIEVE THE CellAED®
If the patient is unconscious, unresponsive, and not breathing normally, or if
you are unsure whether they are in SCA, call or have a bystander call
Emergency Services. Send a bystander to retrieve the CellAED®, or if you are
alone, retrieve the CellAED® before commencing chest compression CPR (for
instructions, see STEP 4).
If the patient is between 1-8 years old, you are alone, and a telephone is not
close by, commence chest compression CPR (for instructions,
see STEP 4) for 1 minute (60 seconds), before retrieving a telephone and
calling Emergency Services, and retrieving a CellAED®. Inform Emergency
Services that you have a CellAED® and follow their instructions.
STEP 4 START CHEST COMPRESSION CPR
Start chest compression CPR to keep the patient’s blood flowing. To perform
chest compression CPR on a patient weighing greater than 10 kg (22 lbs)
(Figure 7, page 36), complete the following:
i) Place the heel of one hand over the sternum, in the centre of the patient’s
chest. Place your other hand on top of the first and interlock your fingers.
ii) Position yourself above the patient’s chest.
iii) Keeping your arms straight, press straight down on their chest and
deliver chest compressions of no more than one third of the patient’s chest
cavity.
iv) Release the pressure. Pressing down and releasing is 1 compression.
Perform chest compression CPR at a rate of 120 per minute (twice per second)
for 1 minute (60 seconds).
(Continued page 36) 35
FIGURE 7: Chest compression CPR
STEP 5
PREPARE THE PATIENT FOR TREATMENT WITH THE CellAED®
The CellAED® has been designed for use on people who are unconscious, unresponsive, and who have ceased breathing or have abnormal (agonal) breathing associated with SCA.
DANGER: Do not store or use the CellAED® near flammable gases (such as in an oxygen-enriched atmosphere) or in direct contact with flammable material. Store in a dry location away from any heat sources (including direct sunlight). Turn off local gas sources or move source away from patient during defibrillation.
36
WARNING: The CellAED® should not be used if the patient is conscious,
responsive, or breathing normally. No shockable rhythm will be detected and
the CellAED® will not provide shocks. Call Emergency Services if symptoms of
concern are present.
If you are unsure whether a sudden cardiac arrest is occurring, use the
CellAED®.
If the patient remains unconscious, unresponsive, or not breathing normally
after 60 seconds, obtain the CellAED® and prepare the patient for treatment.
– Remove clothing and jewellery and expose the patient’s chest (Figure 8, page
36). Cut through clothing with scissors if necessary.
– Shave any excessive hair in the areas where you will place the pads.
– If the chest is dirty or moist, wipe the chest with a towel to make the skin
dry and clean for good pad contact.
– Remove any medicine patches on the patient’s chest.
– Remove any electronic devices or equipment attached to the patient that do
not feature the `defibrillation-proof’ mark.
WARNING: Certain materials making contact with the electrode pads during
defibrillation can cause electrical sparks, skin burns, and divert electricity
away from the heart. Do not allow the electrode pads to touch each other or
any metal parts or objects (such as a bed frame or stretcher); medication
patches; dressings; or any other material on the patient’s chest or in contact
with the patient.
– Continue to provide chest compression CPR. – If possible, call for
assistance as you prepare
the CellAED® for use.
FIGURE 8: Expose chest for defibrillation
STEP 6
REMOVE THE CellAED® FROM THE PACKAGING
i) Open the tamper evident seal by lifting the red tab and peeling the red
seal from the lateral edges of the protective case (Figure 1, page 21)
ii) Remove the sealed transparent bag and the CellAED®.
iii) Tear open the sealed transparent bag where the bag reads `Tear here’ and
remove the CellAED® (Figure 2B, page 23).
STEP 7 DEFIBRILLATE USING THE CellAED®
To activate the CellAED®, perform the Snap Peel StickTM actions as shown in
Figure 9A, page 37.
i) Hold the CellAED® with two hands with the label side facing up and side
featuring `THIS SIDE FACE DOWN’ facing down.
ii) SNAP the CellAED® into two separate pads along the center line, by
applying pressure downwards in a snapping or folding motion.
iii) This activates the CellAED® to deliver audio (voice) prompts (Section 8,
pages 44 – 49) to guide you in using the CellAED®.
FIGURE 9A: Instructions for patients weighing greater than 10 kg (22 lbs)
iv) Pull the two pads apart and PEEL off the protective liner from the bottom
marked `THIS SIDE FACE DOWN’. It should be completely removed so that the
adhesive pads are exposed and ready to apply to the patient.
v) Fully extend the cable connecting the two pads.
vi) STICK one pad firmly onto the patient’s exposed skin just below their
right collar bone, above the breast. STICK the other pad onto the patient’s
exposed skin on their left side, below or under the breast (Figure 9B, page
37). Press firmly so that the entire pad adheres to the patient’s skin.
FIGURE 9B: STICK placement for adult males & females
(Continued page 38) 37
DANGER: Correct pad placement and good pad contact with the skin is critical
(refer to Figure 9A, page 37 for patients weighing greater than 10 kg
(22lbs)).
WARNING: Air pockets between the skin and electrode pads can cause ineffective
treatment. Make sure electrode pads are completely adhered to the skin. If
necessary and possible, shave hair from the area to ensure good contact. Do
not use damaged, expired, or dried out electrode pads.
vii) If the patient has a pacemaker (indicated by a raised bump under their
skin), position the pads at least 2.5 cm (1″) from the device.
WARNING: If a patient has a pacemaker, never stick an electrode pad over the
pacemaker, as it may reduce the accuracy of analysis, generate errors in
detecting shockable rhythms, and result in ineffective treatment.
viii) Follow the audio (voice) prompt instructions as directed and do not
touch the patient unless instructed to do so.
If the CellAED® heart rhythm analysis determines that a shock is needed, the
audio (voice) prompts will announce SHOCK ADVISED and then instruct DO NOT
TOUCH PATIENT, followed by STAND CLEAR FOR SHOCK. Do 38
not touch the patient when these prompts are heard and whilst the red LED is
illuminated. The CellAED® will advise when to commence chest compression CPR.
DANGER: Do not remove the electrode pads from the patient during or after
rhythm recognition, during charging, or while the shock is being delivered.
The shocks delivered by the CellAED® can cause serious harm to user(s) or
bystanders if the instructions are not followed.
WARNING: The CellAED® cannot abort a shock once a shockable rhythm has been
detected. The CellAED® delivers up to 85 Joules of electrical energy with
every electrical pulse (shock).
WARNING: The energy emitted by the CellAED® can be conducted through the
patient or conductive matter touching the patient. Therefore:
– Do not touch the patient, electrode pads, metal objects such as a bedframe
or stretcher in contact with the patient, or any other material in contact
with the patient while the shock is being delivered. These shocks can cause
serious harm to user(s) or bystanders if the instructions are not followed.
– Do not use the CellAED® when the patient is in or is near a pool of water or
on any other conductive surface(s). Carefully remove the patient if necessary.
Ensure the patient is dry before using the CellAED®.
Deliver chest compression CPR when instructed by the audio (voice) prompts.
The CellAED® will issue an audio mentronome to guide the user in providing
chest compressions at the correct rate (120 per minute). Continue chest
compression CPR until:
– The patient recovers and is breathing normally, or
– Qualified medical help is ready to take over, or
– A healthcare professional instructs you to stop, or
– It is physically impossible to continue, or
– The CellAED® advises the user to stop chest compression CPR.
If the patient starts moving, coughing, or breathing regularly, place the
patient in the recovery position (Figure 10, page 39) and keep them as still
as possible until Emergency Services arrive.
DANGER: Pregnant women must be lain on their left side in the recovery
position.
CAUTION: Temporary redness of the skin may occur where the electrodes were
attached. This is not concerning unless the patient experiences pain, in which
case inform the patient’s healthcare provider so that the patient can receive
the appropriate care.
When finished using the CellAED®, stick the gel side of the pads together for
at least five seconds. This will deactivate the CellAED® defibrillation
functions and audio (voice) prompts.
FIGURE 10: Move patient into recovery position
(Continued page 40) 39
7.5 RESPONDING TO A SUDDEN CARDIAC ARREST USING THE CellAED® ON AN INFANT
WEIGHING LESS THAN 10 kg (22 lbs)
DANGER: Infant Mode can only be enabled at the correct time. See Step 7, page
42.
STEP 1 ASSESS SAFETY OF LOCATION
Ensure that no obvious danger is present, and that the area is safe for you to
provide chest compression CPR and administer the CellAED®.
DANGER: Do not use the CellAED® while the infant is in or is near a pool of
water or on any other conductive surface(s). Carefully remove the infant if
necessary. Ensure that the infant is dry before using the CellAED®.
STEP 2
DETERMINE WHETHER THE INFANT IS IN SUDDEN CARDIAC ARREST
STEP 3
CALL EMERGENCY SERVICES AND RETRIEVE THE CellAED®
If the infant is unconscious, unresponsive, and not breathing normally, or if you are unsure whether they are in SCA, remain with the infant and call or have a bystander call Emergency Services. Send a bystander to retrieve the CellAED®. Inform Emergency Services that you have an automated external defibrillator (AED) and follow their instructions.
If you are alone, and a telephone is not close by, commence chest compression CPR (for instructions, see STEP 4) for 1 minute (60 seconds), before retrieving a telephone and calling Emergency Services, and retrieving a CellAED®. Inform Emergency Services that you have an automated external defibrillator (AED) and follow their instructions.
An infant in SCA is typically:
· Unconscious, · Unresponsive when you talk to, touch, or tickle
their feet/under their arms (Figure 11, page 41), and · Not breathing or
taking occasional gasping
breaths, accompanied by strange vocalizations and muscle spasms (agonal
breathing). 40
STEP 4 START CHEST COMPRESSION CPR
Start chest compression CPR to keep the infant’s blood flowing. To perform
chest compression CPR on an infant weighing less than 10 kg (22 lbs) (Figure
12, page 41), complete the following:
i) Place 2 fingers over the sternum, in the centre of the patient’s chest.
ii) Press straight down on their chest and deliver chest compressions of no
more than one third of the infant’s chest cavity.
iii) Release the pressure. Pressing down and releasing is 1 compression.
Perform 5 chest compression CPR and check for breathing (Figure 12, page 41).
If the infant remains unresponsive and not breathing normally, commence chest
compression CPR at a rate of 120 per minute (twice per second) for 1 minute
(60 seconds).
STEP 5
PREPARE THE INFANT FOR TREATMENT WITH THE CellAED®
The CellAED® has been designed for use on people who are unresponsive and unconscious, and who have ceased breathing or have abnormal (agonal) breathing associated with SCA.
DANGER: Do not store or use the CellAED® near flammable gases (such as in an oxygen-enriched atmosphere) or in direct contact with flammable material. Store in a dry location away from any heat sources
(including direct sunlight). Turn off local gas sources or move source away from patient during defibrillation.
WARNING: The CellAED® should not be used if the infant is conscious,
responsive, or breathing normally. No shockable rhythm will be detected and
the CellAED® will not provide shocks. Call Emergency Services if symptoms of
concern are present.
If you are unsure whether a sudden cardiac arrest is occurring, use the
CellAED®.
If the infant remains unconscious, unresponsive, or not breathing normally
after 60 seconds, obtain the CellAED® and prepare the infant for treatment.
– Remove clothing and jewellery and expose the infant’s chest (Figure 13, page
41). Cut through clothing with scissors if necessary.
– If the chest is dirty or moist, wipe the chest with a towel to make the skin
dry and clean for good pad contact.
– Remove any medicine patches on the infant’s chest.
– Remove any electronic devices or equipment attached to the patient that do
not feature the `defibrillation-proof’ mark.
FIGURE 11: Check if infant is responsive or normal breathing
FIGURE 12: Chest compression
FIGURE 13: Expose chest for defibrillation
WARNING: Certain materials making contact with the electrode pads during
defibrillation can cause electrical sparks, skin burns, and divert electricity
away from the heart. Do not allow the electrode pads to touch each other or
any metal parts or objects (such as a bed frame or stretcher); medication
patches; dressings; or any other material on the patient’s chest or in contact
with the patient.
– Continue to provide chest compression CPR.
– If possible, call for assistance as you prepare the CellAED® for use.
STEP 6
REMOVE THE CellAED® FROM THE PACKAGING
i) Open the tamper evident seal by lifting the red tab and peeling the red
seal from the lateral edges of the protective case (Figure 1, page 21).
ii) Remove the sealed transparent bag and the CellAED®.
iii) Tear open the sealed transparent bag where the bag reads `Tear here’ and
remove the CellAED® (Figure 2, page 23).
(Continued page 42) 41
STEP 7 DEFIBRILLATE USING THE CellAED®
To activate the CellAED®, perform the Snap Peel StickTM actions (Figure 14,
page 42).
i) Hold the CellAED® with two hands with the label side facing up and side
featuring THIS SIDE FACE DOWN’ facing down. ii) SNAP the CellAED® into two separate pads along the center line, by applying pressure downwards in a snapping or folding motion. iii) This activates the CellAED® to deliver audio (voice) prompts (Section 8, pages 44 – 49) to guide you in using the CellAED®. iv) Pull the two pads apart and PEEL off the protective liner from the bottom marked
THIS SIDE FACE DOWN’. It should be completely removed so that the
adhesive pads are exposed and ready to apply to the infant.
v) Fully extend the cable connecting the two pads. vi) STICK the pad featuring
the blue Infant Mode
button firmly onto the infant’s exposed skin on the chest between the nipples
(Figure 14, page 42). Press firmly so that the entire pad adheres to the
infant’s skin.
42
FIGURE 14: Instructions for infants less than 10 kg (22 lbs)
vii) Grasp the infant’s shoulder to roll them onto their front, supporting
their head where necessary, and STICK the other pad firmly to their back in
the center. Press firmly so that the entire pad adheres to the infant’s skin
and roll them back onto their back.
DANGER: Correct pad placement and good pad contact with the skin is critical
(refer to Figure 14, page 42 for Infants weighing less than 10 kg (22 lbs)).
WARNING: Air pockets between the skin and electrode pads can cause ineffective
treatment. Make sure electrode pads are completely adhered to the skin. Do not
use damaged, expired, or dried out electrode pads.
viii) When prompted, press the infant button. Press the infant button a second
time to confirm and enable INFANT MODE.
ix) Follow the audio (voice) prompt instructions as directed and do not touch
the infant unless instructed to do so.
If the CellAED® heart rhythm analysis determines that a shock is needed, the
audio (voice) prompt will announce SHOCK ADVISED and then instruct DO NOT
TOUCH PATIENT, followed by STAND CLEAR FOR SHOCK. Do not touch the patient
when these prompts are heard and whilst the red LED is illuminated. The
CellAED® will advise when to commence chest compression CPR.
DANGER: Do not remove the electrode pads from the patient during or after
rhythm recognition, during charging, or while the shock is being delivered.
The shocks delivered by the CellAED® can cause serious harm to user(s) or
bystanders if the instructions are not followed.
WARNING: The CellAED® cannot abort a shock once a shockable rhythm has been
detected. The CellAED® delivers up to 45 Joules of electrical energy in Infant
Mode with every electrical pulse (shock).
WARNING: The energy emitted by the CellAED® can be conducted through the
patient or conductive matter touching the patient. Therefore:
– Do not touch the patient, electrode pads, metal objects such as a bedframe
or stretcher in contact
with the patient, or any other material in contact with the patient while the
shock is being delivered. These shocks can cause serious harm to user(s) or
bystanders if the instructions are not followed.
– Do not use the CellAED® when the patient is in or is near a pool of water or
on any other conductive surface(s). Carefully remove the patient if necessary.
Ensure the patient is dry before using the CellAED®.
When the audio (voice) prompts to begin chest compression CPR is heard, remove
the front electrode pad and set aside carefully. The CellAED® will issue an
audio metronome to guide the chest compression rate. Replace the front pad for
heart rhythm analysis when instructed.
DANGER: Take care to place the electrode pad gelside up when removed. Do not
touch the exposed electrode or stick the pad to any object, as this may
contaminate the electroconductive gel and compromise the performance of the
CellAED®.
– The CellAED® advises the user to stop chest compression CPR.
If the infant starts moving, coughing, or breathing regularly, place the
infant in the recovery position (Figure 15, page 43) and keep them as still as
possible until Emergency Services arrive.
CAUTION: Temporary redness of the skin may occur where the electrodes were
attached. This is not concerning unless the infant experiences pain, in which
case inform the infant’s healthcare provider so that the infant can receive
the appropriate care.
When finished using the CellAED®, stick the gel side of the pads together for
at least five seconds. This will deactivate the CellAED® defibrillation
functions and audio (voice) prompts.
Continue chest compression CPR until:
– The infant recovers and is breathing normally, or – Qualified medical help is ready to take over, or – A healthcare professional instructs you to stop, or – It is physically impossible to continue.
FIGURE 15: Infant recovery position 43
08 VOICE PROMPT INSTRUCTIONS
AUDIO (VOICE) PROMPT INSTRUCTIONS CALL FOR HELP. REMAIN CALM. Call your local emergency services, or if possible, have a bystander call the local emergency services. Remain calm.
FOR ADULT, APPLY PADS ACROSS CHEST. FOR INFANT, APPLY PADS TO CHEST AND BACK.
Apply the electrode pads as instructed. Be prepared beforehand to place the electrode pads correctly. Take note of the difference between patients weighing greater than 10 kg (22 lbs) (both pads applied to the chest) and infants weighing less than 10 kg (22lbs) (one pad applied to the chest and one applied to the back) (refer to Figure 9A (page 37) for patients weighing greater than 10 kg (22lbs) and Figure 14 (page 42) for infants weighing less than 10 kg (22lbs)).
FOR INFANTS, PRESS INFANT BUTTON
For infants weighing less than 10 kg (22 lbs) (typically less than 1 year old), press the infant button (Figure 5(d), page 34) within 10 seconds of this audio (voice) prompt to provide the correct therapy. If the button is not pressed, the audio (voice) prompt is repeated once. Failure to use the correct setting may result in harm to the patient and/or ineffective treatment.
PRESS INFANT BUTTON TO CONFIRM INFANT MODE
For infants weighing less than 10 kg (22 lbs) (typically less than 1 year old), press the infant button (Figure 5(d), page 34) within 5 seconds of this audio (voice) prompt to confirm and enable Infant Mode. Failure to use the correct setting may result in harm to the patient and/or ineffective treatment.
INFANT MODE ENABLED
Infant Mode has been enabled. The CellAED® will automatically adjust its therapy. No operator or user action is required.
ANALYSING HEART RHYTHM
The CellAED® has begun automatically analysing the patient’s heart rhythm. Do not touch the patient during the analysis.
DO NOT TOUCH PATIENT
Remove all contact of yourself and anyone else touching any part of the patient. Failure to do so may result in ineffective treatment and/or harm to the operator or patient.
44
SHOCK NOT ADVISED SHOCK ADVISED STAND CLEAR FOR SHOCK SHOCK DELIVERED BEGIN
CPR
CONTINUE CPR STOP CPR DEVICE DEACTIVATED
The CellAED® has not detected a shockable rhythm (VF or VT). No operator or
user action is required.
The CellAED® has detected a shockable rhythm (VF or VT) and the CellAED® is
preparing to defibrillate the patient. The red LED will turn on to indicate
the CellAED® is charging. Do not touch the patient during this time. Remove
all contact of yourself and anyone else touching any part of the patient.
Failure to do so may result in ineffective treatment and/or harm to the
operator or patient. The CellAED® has discharged an electric shock to the
patient. No operator or user action is required.
Immediately begin chest compression CPR at the rate provided by the audio
metronome. For instructions on performing chest compression CPR on patients
weighing greater than 10 kg (22 lbs), see Section 7.4, Step 4, page 35. For
instructions on performing chest compression CPR on infants weighing less than
10 kg (22 lbs), see Section 7.5, Step 4, page 40. Continue chest compression
CPR at the rate provided by the audio metronome.
Stop performing chest compression CPR.
The CellAED® has been deactivated. Carefully set aside. Contact the
manufacturer for a replacement and instructions to dispose of the CellAED®.
45
FIGURE 16A: Step-by-Step CellAED® Audio instructions (Patients weighing greater than 10 kg (22 lbs))
INSTRUCTIONS FOR PATIENTS WEIGHING GREATER THAN 10 kg (22 lbs)
SNAP
PEEL
STICK
“Shock not advised” “Begin CPR”
If no shockable rhythm
“Call for help” “Remain calm”
46
If shockable rhythm
“For adult, apply pads across chest. For infant, apply pads to chest & back”
“Analysing heart rhythm”
Check pads for good contact
“Do not touch patient”
“Shock advised” “Do not touch patient”
Voice commands
SHOCK
DELIVERED
“Stand clear for shock”
“Shock delivered”
“Begin CPR”
Continue CPR for 2 minutes or until
help arrives or patient recovers
If pads together
CellAED® deactivated. Contact nearest distributor
for disposal instructions.
“Continue CPR” “Stop CPR”
“Device deactivated”
47
FIGURE 16B: Step-by-Step CellAED® Audio instructions (Infants weighing less
than 10 kg (22 lbs))
INSTRUCTIONS FOR INFANTS WEIGHING LESS THAN 10 kg (22 lbs)
SNAP
PEEL
STICK
“Call for help” “Remain calm”
48
“For adult, apply pads across chest. For infant, apply pads to chest & back”
Check pads for good contact
“For infants, press infant button”
“Press infant button to confirm Infant Mode” “Infant Mode enabled”
“Analysing heart rhythm”
“Do not touch patient”
“Shock not advised” “Begin CPR”
If no shockable rhythm
If shockable rhythm
“Shock advised” “Do not touch patient”
SHOCK
DELIVERED
“Stand clear for shock”
“Shock delivered”
“Begin CPR”
Voice commands
Continue CPR for 2 minutes or until
help arrives or patient recovers
If pads together
CellAED® deactivated. Contact nearest distributor
for disposal instructions.
“Continue CPR” “Stop CPR”
“Device deactivated”
49
09 TROUBLESHOOTING
This Section explains problems you may encounter while using the CellAED®, its
possible causes and what you should do in such an event. Immediately inform
the manufacturer directly or through an authorised dealer about any
malfunction of a CellAED®.
PROBLEM
The CellAED® does not activate or charge
POSSIBLE CAUSES Battery depleted
WHAT TO DO
Administer chest compression CPR if the patient is not responding, not
breathing normally, or not moving, until Emergency Services arrive. Contact
the manufacturer for a replacement and instructions to dispose of the
CellAED®.
There is no LED status
Battery depleted CellAED® expired CellAED® is non-functional
Administer chest compression CPR if the patient is not responding, not breathing normally, or not moving, until Emergency Services arrive. Contact the manufacturer for a replacement and instructions to dispose of the CellAED®.
Peeling or damaged sealed transparent bag on visual inspection
Expired CellAED® Damaged CellAED®
Administer chest compression CPR if the patient is not responding, not breathing normally, or not moving, until Emergency Services arrive. Contact the manufacturer for a replacement and instructions to dispose of the CellAED®.
Cable is not extended completely
50
Cable stuck in enclosure
Pull the pads directly apart using mild force.
PROBLEM Electrode pads are not adhering to the patient
Audio (voice) prompt to apply pads to patient is continuing, after the
operator has applied pads to patient
POSSIBLE CAUSES
Poor surface preparation Electrode pads expired
WHAT TO DO
Clean, shave, and dry the patient’s skin. Firmly press the pads on the
patient’s bare skin. Ensure that the entire pad adheres to the patient’s skin.
If poor detection persists, administer chest compression CPR if the patient is
not responding, not breathing normally, or not moving until Emergency Services
arrive. Contact the manufacturer for a replacement and instructions to dispose
of the CellAED®.
Poor pad contact to patient Poor surface preparation
Clean, shave, and dry the patient’s skin. Firmly press the pads on the patient’s bare skin. Ensure that the entire pad adheres to the patient’s skin. If poor detection persists, administer chest compression CPR if the patient is not responding, not breathing normally, or not moving until Emergency Services arrive. Contact the manufacturer for a replacement and instructions to dispose of the CellAED®.
Audio (voice) prompts sound faint or distorted
Speaker is covered Speaker failure Battery low CellAED® expired
If the Red LED is ON, do not touch patient and stand clear for shock as CellAED® will deliver an electric shock automatically. Ensure that the location of the speaker is not covered, which could muffle or dampen the audio (voice) prompts. If there is no improvement, administer chest compression CPR if the patient is not responding, not breathing normally, or not moving, until Emergency Services arrive. Contact the manufacturer for a replacement and instructions to dispose of the CellAED®.
51
10 TECHNICAL SPECIFICATIONS AND INFORMATION
10.1 TECHNICAL TERMINOLOGIES/ACRONYMS
TERMINOLOGY/ ACRONYMS ABS EIRP EMI EMS ESD IEC Impedance IP ISO ISTA Joule (J) MIL-STD RF RFI SAR 52
DESCRIPTION Acrylonitrile Butadiene Styrene Effective Isotropic Radiated Power Electromagnetic Interference Emergency Medical Services Electrostatic Discharge International Electrotechnical Commission Resistance to the flow of electrical current Ingress Protection International Organization for Standardisation International Safe Transit Association The basic unit of energy delivered by a defibrillator. The amount of energy delivered during defibrillation in Watt-seconds Military Standard Radio Frequency Radio Frequency Interference Specific Absorption Rate
10.2 TECHNICAL CHARACTERISTICS AND SPECIFICATIONS
GENERAL SPECIFICATIONS
ENCLOSURE DIMENSIONS (W X D X H) WEIGHT BATTERY FIRMWARE VERSION
ABS/Polycarbonate fire retardant blend 196 mm x 93 mm x 17 mm Approximately 300 g Non-rechargeable Lithium 1.x
PERFORMANCE SPECIFICATIONS
PRE-PROGRAMMED MAXIMUM NUMBER OF SHOCKS NUMBER OF MAXIMUM ENERGY SHOCKS
DELIVERED WHEN LOW BATTERY EVENT OCCURS CHARGING TIME TO MAXIMUM ENERGY WITH A
NEW BATTERY CHARGING TIME TO MAXIMUM ENERGY WITH A BATTERY AFTER 6 SHOCKS ECG
INTERPRETATION TIME WITH A NEW BATTERY ECG INTERPRETATION TIME WITH A BATTERY
AFTER 6 SHOCKS TIME TO MAXIMUM ENERGY SHOCK AFTER ACTIVATION
20 shocks > 3 shocks < 25 seconds < 25 seconds < 8 seconds < 8 seconds < 50 seconds
(Continued page 54) 53
CLASSIFICATION OF MEDICAL ELECTRICAL EQUIPMENT
EQUIPMENT CLASSIFICATION
Class II Internally Powered Type BF medical device
CONFORMITY (EU)
Council Directive 93/42/EEC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU, WEEE Directive 2012/19/EU
CONFORMITY (AU)
Therapeutic Goods (Medical Devices) Regulations 2002, (AU) Telecommunications Act 1997
CONFORMITY (NZ)
Medicines Regulations 1984, (NZ) Telecommunications Act 2001, RoHS Directive 2011/65/EU
CONFORMITY (UK)
The Medical Devices Regulations 2002, UK Radio Equipment Regulations 2017, The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012, The Waste Electric and Electronic Equipment (WEEE) Regulations 2013
CellAED® INGRESS PROTECTION IP 22
MODE OF OPERATION
Continuous, infrequent single event use only
ELECTRODE SPECIFICATIONS
ELECTRICAL CONNECTING CABLE CONTACT AREA
1 m, 28 AWG Total combined area: 166 cm2
ELECTRODE MATERIAL
Hydrogel
ELECTRODE DIMENSIONS
9 cm x 9.25 cm
ENVIRONMENTAL SPECIFICATIONS
OPERATING CONDITIONS
0 ºC to 35 ºC (32 ºF to 95 ºF), 0% to 95% RH (relative humidity) (non- condensing)
STANDBY/STORAGE CONDITIONS 54
15 ºC to 35 ºC (59 ºF to 95 ºF), 0% to 95% RH (relative humidity) (non- condensing)
TRANSPORT CONDITIONS
0 ºC to 35 ºC (32 ºF to 95 ºF), 0% to 95% RH (relative humidity) (non- condensing)
ALTITUDE
-100 m to 4,000 m
ATMOSPHERIC PRESSURE
60 kPa to 102 kPa
SHOCK/DROP/VIBRATION
Transit Operable, Portable Device (EN 60601-1-11:2015, EN 60601-1-6:2010+A1:2015)
ESD/EMI (radiated and immunity) See electromagnetic conformity tables (Section 10.5, pages 58-61)
UMTS BANDS
800, 850, 900, 1900, 2100
FREQUENCY
GSM 900: 880 MHz ~ 915 MHz, DCS 1800: 1710 MHz ~ 1785 MHz, WCDMA Band 1: 1920 MHz ~ 1980 MHz, CDMA Band 8: 880 MHz ~ 915 MHz
SAR
GSM 900: 0.192 W/kg, DCS 1800: 0.107 W/kg, WCDMA Band 1: 0.189 W/kg, WCDMA Band 8: 0.059 W/kg
EIRP
GSM900: 31.61 dBm, DCS1800: 32.91 dBm, WCDMA 2100 (Band I): 26.48 dBm, WCDMA 900 (Band VIII): 22.65 dBm
STANDARDS COMPLIANCE
MEDICAL DEVICE
IEC 60601-2-4:2010+AMD1:2018, EN 60601-2-4:2011/A1:2019, IEC 60601-1-11:2015 & EN 60601-1-11:2015
SYMBOLS
ISO 15223-1; UL61010
RESTRICTION OF HAZARDOUS SUBSTANCE DIRECTIVE (RoHS)
EU Directive 2011/65/EU
ESD/EMI
EN 60601-1-2:2015, EN 60601-2-4:2011+A1:2019, CISPR 11 Group 1 Class B, EN 61000-4-2 Severity Level 4 (Open air discharges up to 8 kV or Direct/Indirect contact discharges up to 6 kV)
BIOCOMPATIBILITY
EN ISO 10993-1:2020
TRANSPORTATION
ANSI ISTA Procedure 3A
55
10.3 BIPHASIC EXPONENTIAL WAVEFORM
PATIENT WEIGHING GREATER THAN 10 kg (22 lbs)
IMPEDANCE () ENERGY (J)
25
68
50
75
75
78
100
80
125
80
150
81
175
81
V1 (V) 1050 1150 1183 1204 1212 1224 1235
PEAK I1 (A) 42.0 23.0 15.8 12.0 9.7 8.2 7.1
T1 (ms) 5.2 9.7 14.2 18.8 20.1 20.0 20.0
V2 (V) 1005 1120 1166 1190 1200 1212 1221
PEAK I2 (A) 40.2 22.4 15.6 11.9 9.6 8.1 7.0
T2 (ms) 2.7 4.8 7.0 10.0 16.4 22.1 22.1
INFANT WEIGHING LESS THAN 10 kg (22 lbs)
IMPEDANCE () ENERGY (J)
25
36
50
40
75
42
100
43
125
43
150
43
175
43
V1 (V) 762 835 861 876 885 891 896
PEAK I1 (A) 30.4 16.7 11.5 8.8 7.1 5.9 5.1
T1 (ms) 5.2 9.6 14.1 18.5 20.1 20.1 20.1
V2 (V) 743 824 855 872 880 888 892
PEAK I2 (A) 29.8 16.5 11.4 8.7 7.0 5.9 5.1
T2 (ms) 3.1 5.5 8.0 10.6 15.6 21.9 22.2
The energy delivered is within +/- 15% of the nominal values shown above.
56
V V1 T1
V = Voltage t = Time
The waveform is automatically
adjusted to compensate for
T2
patient impedance.
t The CellAED® does not detect patient motion.
V2
PERFORMANCE
WAVEFORM
Equal leading-edge Biphasic Exponential
ENERGY OUTPUT & DELIVERY Up to 85 Joules
RESISTANCE MEASUREMENT 25 to 175 Ohms, non-inductive (<2uH)
2-MINUTE STANDARD CPR AMA standards
SHOCK DELIVERY
Fully Automatic
AUDIBLE VOICE PROMPTS Up to 16 unique messages
AUDIO VOLUME
75 dBA
10.4 ECG INTERPRETATION AND PERFORMANCE
When placed on a patient meeting the indication for use criteria, the CellAED®
is designed to recommend a defibrillation shock when it detects proper pad
impedance and one of the following shockable rhythms:
SHOCKABLE RHYTHMS
VF with peak-to-peak amplitudes of at least 200µV and VT (monomorphic and
polymorphic) of at least 130 bpm and peak-to-peak amplitudes of at least
200µV.
NON-SHOCKABLE RHYTHMS
All other rhythms, including Normal Sinus Rhythms, fine VF with peak-to-peak
amplitudes less than 200µV, some slow VT and Asystole.
SENSITIVITY AND SPECIFICITY OF RHYTHM RECOGNITION DETECTOR
Shockable Rhythm VF
Meets IEC/EN 60601-2-4 requirement Sensitivity > 90%
Shockable Rhythm VT
Meets IEC/EN 60601-2-4 requirement Sensitivity > 75%
Non-shockable Rhythm Normal Sinus Rhythm
Meets IEC/EN 60601-2-4 requirement Specificity > 95%
Non-shockable Rhythm Asystole
Meets IEC/EN 60601-2-4 requirement Specificity > 95%
Non-shockable Rhythm all other rhythms
Meets IEC/EN 60601-2-4 requirement Specificity > 95%
The patient’s transthoracic impedance is measured through the defibrillation
electrode pads. If the baseline impedance is higher than 175 ohms, it is
determined that the electrodes have not made sufficient contact, and ECG
analysis and shock delivery are inhibited. In this instance please check the
electrodes and improve contact.
57
10.5 GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC EMISSIONS AND
IMMUNITY
10.5.1 ELECTROMAGNETIC EMISSIONS (IEC 60601-1-2:2014/EN 60601-1-2:2015 TABLE
201)
The CellAED® is intended for use in the electromagnetic environment specified
below. The users must ensure that it is used in such an environment.
EMISSIONS TEST RF emissions CISPR 11
COMPLIANCE LEVEL
Group 1 Class B
ELECTROMAGNETIC ENVIRONMENT
The RF emissions of the CellAED® are unlikely to cause any interference in
nearby electronic equipment. The CellAED® is suitable for use in all
establishments, including industrial establishments, domestic establishments
and establishments directly connected to the public low-voltage power supply
for domestic purpose.
58
10.5.2 ELECTROMAGNETIC IMMUNITY (IEC 60601-1-2:2014/EN 60601-1-2:2015 TABLE
202)
The CellAED® is intended for use in the electromagnetic environment specified
below. The users must ensure that it is used in such an environment.
IMMUNITY TEST
Electrostatic Discharge (ESD) IEC 61000-4-2:2008, EN61000-4-2:2009
IEC 60601-1-2:2014/EN 606011-2:2015 TEST LEVEL
±2kV , ±4kV, ±6kV for Direct & Indirect Contact ±2kV, ±4kV, ±8Kv for Air
Discharge
COMPLIANCE LEVEL
±2kV , ±4kV, ±6kV for Direct & Indirect Contact ±2kV, ±4kV, ±8Kv for Air
Discharge
ELECTROMAGNETIC ENVIRONMENT
There are no special requirements with respect to electrostatic discharge.
Power-frequency magnetic field IEC IEC 61000-4-8:2009/EN 61000-48:2009
30 A/m 50Hz
30 A/m 50Hz
Power-frequency magnetic fields should not be greater than magnitudes which
are typical of commercial or hospital environments. There are no special
requirements for non-commercial/nonhospital environments.
(Continued page 60) 59
IMMUNITY TEST
Radiated RF EM Fields IEC 61000-43:2006/ A1:2007+A2:2010
IEC 60601-1-2:2014/EN 606011-2:2015 TEST LEVEL
10 V/m, 20 V/m 80MHz to 2.5GHz
COMPLIANCE LEVEL 10V/m
60 (Continued page 61)
ELECTROMAGNETIC ENVIRONMENT
Portable and mobile RF communications equipment should be used no closer to
any part of the CellAED®, including cables, than is necessary. The recommended
separation distance calculated from the equation applicable to the frequency
of the transmitter is shown in the following table.
Recommended separation distance d = 1.20 x P, 80MHz to 800MHz d = 2.30 x P,
800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in meters (m).
Interference may occur in the vicinity of equipment marked with the symbol
above.
Note 1: At 80MHz and 800 MHz, the higher frequency range applies Note 2: These
guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
The ISM (Industrial, Scientific and medical) bands between 150 kHz and 80 kHz
are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283
MHz; and 40.66 MHz to 40.70 MHz
The compliance level in the ISM (Industrial, Scientific and Medical) frequency
bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz
are intended to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into the
area around the patient. For this reason, an additional factor of 10/3 is used
in calculating the recommended separation distance for transmitters in these
frequency ranges. Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey, should be less than the compliance level in
each frequency range. Field strengths from fixed transmitters, such as base
stations for radio (cellular / cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If
the measured field strength in the location in which the CellAED® is used
exceeds the applicable RF compliance level above, the CellAED® should be
observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the
CellAED®. Over the frequency range 150 kHz to 80 MHz, field strengths should
be less than 3 V/m.
61
10.6 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE CellAED® (IEC 60601-1-2:2014/EN
60601-1-2:2015 TABLE 205)
The CellAED® is intended for use in an environment in which radiated RF
disturbances are controlled. The customer or the user of the CellAED® can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
CellAED® as recommended below, according to the maximum output power of the
communications equipment.
RATED MAXIMUM OUTPUT POWER OF TRANSMITTER
(W) 0.01 0.1
1 10 100
SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER (M)
150 KHZ TO 80 MHZ OUTSIDE ISM BANDS
150 KHZ TO 80 MHZ IN ISM BANDS
80 KHZ TO 800 MHZ
d = [3.5/3] x P 0.17 0.37 1.17 3.69 11.70
d = [12/10] x P 0.12 0.38 1.20 3.79 12.00
d = [12/10] x P 0.12 0.38 1.20 3.79 12.00
800 MHZ TO 2.5 GHZ
d = [23/10] x P .023 0.73 2.3 7.27 23.00
62
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be determined using the
equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
Note 2: The ISM (Industrial, Scientific and Medical) bands between 150 kHz and
80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to
27.283 MHz; and 40.66 MHz to 40.70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended
separation distance for transmitters in the ISM frequency bands between 150
kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the
likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects,
and people.
63
11
DANGERS, WARNINGS AND CAUTIONS
It is important to understand how to use the CellAED® safely. Please read the following danger, warning and caution notices carefully. Danger describes hazards that could result in immediate serious personal injury or death to the user and/or the patient. Warning describes hazards or unsafe practices that could result in serious personal injury or death to the user and/or the patient. Caution describes hazards or unsafe practices that could result in minor personal injury to the user and/or the patient, product damage, or property damage. If any serious incidents occur, please contact the relevant representative organization for your region (See Section 12, Page 69)
DANGERS Flammable gas
Battery
Fluids Use of the CellAED®
Do not store or use the CellAED® near flammable gases (such as in an oxygen-
enriched atmosphere) or in direct contact with flammable material. Store in a
dry location away from any heat sources (including direct sunlight). Turn off
local gas sources or move source away from patient during defibrillation.
Failure to comply with any of these conditions may present an explosion risk.
The CellAED® battery is not rechargeable. Do not attempt to recharge, open,
crush, or burn the battery, as this may create an explosion risk or fire
hazard and cause harm to the user. If the battery is depleted, the CellAED®
needs to be replaced. Contact the manufacturer for a replacement and
instructions to dispose of the CellAED®.
Avoid spilling any fluids on the CellAED® enclosure or its electrode pads. Do
not clean the CellAED® with ketones or other flammable agents.
Do not attempt to operate the CellAED® unless thoroughly familiar with this
manual and the functions of all controls, indicators and of the electrode
pads. Users must ensure that they have read and understand the user manual
before use. Use the CellAED® exactly as described in this manual.
64
Use of the CellAED®
Patient handling Children
Infant Mode can only be enabled at the correct time. Once Infant Mode is
enabled, it cannot be reversed into Adult Mode.
The CellAED® has a differentiated use for infants weighing less than 10 kg (22
lbs). You must use Infant Mode for an infant weighing less than 10 kg (22
lbs). Failure to do so may result in ineffective treatment.
When using the CellAED® in Infant Mode and removing the front electrode pad to
begin chest compression CPR, take care to place the electrode pad gel-side up
when removed. Do not touch the exposed electrode or stick the pad to any
object, as this may contaminate the electroconductive gel and compromise the
performance of the CellAED®.
Correct pad placement and good pad contact with the skin is critical.
Do not remove the electrode pads from the patient during or after rhythm
recognition, during charging, or while the shock is being delivered. The
shocks delivered by the CellAED® can cause serious harm to user(s) or
bystanders if the instructions are not followed.
Do not touch the pads to each other outside of deactivation protocol, as this
may damage the electrodes. Do not stick the electrode pad to any object.
The energy emitted by the CellAED® can be conducted through the patient or
conductive matter touching the patient. Therefore: · Do not touch the patient,
electrode pads, metal objects such as a bedframe or stretcher in contact with
the patient, or any other material in contact with the patient while the shock
is being delivered. These shocks can cause serious harm to user(s) or
bystanders if the instructions are not followed. · Do not use the CellAED®
when the patient is in or is near a pool of water or on any other conductive
surface(s). Carefully remove the patient if necessary. Ensure the patient is
dry before using the CellAED®.
Pregnant women must be lain on their left side in the recovery position.
Keep a snapped CellAED® out of the reach of children as the cable presents a
risk of strangulation. After use, contact the manufacturer for a replacement
and instructions to dispose of the CellAED®.
65
Modification of the CellAED®
Single-use
WARNINGS Temperature
Electrical energy
Do not attempt to service or modify the CellAED®. The CellAED® is not intended
for maintenance or service by the user. Modifying the CellAED® in any way may
result in ineffective treatment or cause death or injury. 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.
Modification will void all warranties and present a serious risk of harm to
the user and/or patient. The CellAED® is a single-use device and cannot be re-
used or recycled. If the packaging has been broken or damaged in any way,
contact the manufacturer. Never use a compromised, damaged, expired, or pre-
used CellAED®, as doing so may result in ineffective treatment or user injury.
Contact the manufacturer for a replacement and instructions to dispose of the
CellAED®.
Extreme and fluctuating temperatures will reduce the life of the battery and
electrodes contained within the CellAED®. It is important to follow the
recommended storage temperature as described in this manual. Failure to do so
may result in damage to the CellAED® and improper operation. The CellAED®
should be stored between 15°C – 35°C (59°F – 95°F). Temperatures exceeding
35°C (95°F) can permanently damage the internal battery. The CellAED® cannot
abort a shock once a shockable rhythm has been detected. The CellAED® delivers
up to 85 Joules (45 Joules in Infant Mode) of electrical energy with every
electrical pulse (shock). Do not insert any object into the CellAED®.
66
Use of the CellAED®
Air pockets between the skin and electrode pads can cause ineffective
treatment. Make sure electrode pads are completely adhered to the skin. If
necessary and possible, shave hair from the area to ensure good contact. Do
not use damaged, expired, or dried out electrode pads.
Certain materials making contact with the electrode pads during defibrillation
can cause electrical sparks, skin burns, and/or divert electricity energy away
from the heart. Do not allow the electrode pads to touch each other or any
metal parts or objects (such as a bed frame or stretcher), medication patches,
dressings, or any other material on the patient’s chest or in contact with the
patient.
Do not place the electrode pads together when in use, as this may deactivate
the CellAED® functions including audio (voice) prompts, heart rhythm detection
and classification, capacitor charge and discharge, and render the CellAED®
unusable.
Do not handle or transport the patient while the CellAED® is attached to the patient and analysing the heart rhythm, as this can cause incorrect or delayed diagnosis. Keep the patient as still as possible while the CellAED® is attached.
The CellAED® should not be used if the patient is conscious, responsive, or breathing normally. No shockable rhythm will be detected and the CellAED® will not provide shocks.
If a patient has a pacemaker, never stick the electrode pad over the pacemaker, as it may reduce the accuracy of analysis, generate errors in detecting shockable rhythms, and result in ineffective treatment.
Storage
Colourblind users may have difficulty differentiating between the GREEN and AMBER LEDs. Please seek assistance and be aware of the product’s shelf life.
67
CAUTION Storage Electromagnetic Interference and Radio Frequency Interference
Packaging
Disposal
Store the CellAED® out of reach of pets or children. 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).
Do not open the sealed tamper-proof and protective packaging of the CellAED®
unless you intend to use it. 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. 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 as per
instructions from the manufacturer. After the CellAED® has been used, is
expired, is damaged, or you have doubts about the condition of the CellAED®,
contact the manufacturer, who will provide instructions for the disposal of
the CellAED®. Correct disposal procedure must be observed to ensure that no
dangerous substances are released, which may adversely impact human and/or
environmental health.
68
12
CONTACTS
European Union (EU)
EU Representative EC REP mdi Europa GmbH Langenhagener Straße 71 D-30855
Langenhagen Germany
Manufacturer RRR MANUFACTURING PTY LTD
2 – 6 Skinner Avenue, Riverwood, NSW 2210 Australia
+61 3 7035 4104 rapidresponserevival.com support@rapidresponserevival.com.au
Australia (AU)
Manufacturer RRR MANUFACTURING PTY LTD
2 – 6 Skinner Avenue, Riverwood, NSW 2210 Australia
1300 859 903 rapidresponserevival.com support@rapidresponserevival.com.au
New Zealand (NZ)
United Kingdom (UK)
SPONSOR RRR Manufacturing NZ Limited C/- Nightingale ASSOCIATED LIMITED Level 2, 347 Parnell Road Parnell, Auckland 1052 New Zealand
UK Responsible Person Psephos Limited, Sussex Innovation Centre, Science Park Square, Falmer, Brighton, East Sussex, BN1 9SB, UK
Manufacturer RRR MANUFACTURING PTY LTD
2 – 6 Skinner Avenue, Riverwood, NSW 2210 Australia
Manufacturer RRR MANUFACTURING PTY LTD
2 – 6 Skinner Avenue, Riverwood, NSW 2210 Australia
+64 9884 6891 rapidresponserevival.com support@rapidresponserevival.com.au
+61 3 7035 4104 rapidresponserevival.com support@rapidresponserevival.com.au
Publication date: February 2023
© 2023 CellAED Life Saver Pty Ltd. All rights reserved. Unless otherwise noted all trademarks and the Snap…Peel…Stick trademark are property of CellAED Life Saver Pty Ltd.
69
NOTES
70
NOTES
71
References
- Legal | Rapid Response Revival | AED Company NZ
- Open Source Licensing | Rapid Response Revivial
- Privacy Policy | Rapid Response Revival | AED Company NZ
- Product Specifications | CellAED | Rapid Response Revivial
- Home | AED Suppliers | Rapid Response Revival New Zealand
- Legal | Rapid Response Revival | AED Company NZ
- Legal | Rapid Response Revival | AED Company NZ
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