AED CellAED User Manual
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AED CellAED User Manual

Single-use automated external defibrillator
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USER MANUAL
SINGLE-USE AUTOMATED EXTERNAL DEFIBRILLATOR
Read the User Manual carefully before using the
2
SINGLE-USE AED
CellAED® and keep it for future reference.
SNAP
PEEL
STICK

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Summary of Contents for AED CellAED

  • Page 1 USER MANUAL SINGLE-USE AUTOMATED EXTERNAL DEFIBRILLATOR Read the User Manual carefully before using the SINGLE-USE AED CellAED® and keep it for future reference. SNAP PEEL STICK...

  • Page 2: Table Of Contents

    4.8 More Information 6.3 Storing the CellAED® 02 GLOSSARY 6.4 Maintaining the CellAED® 05 ABOUT CellAED® 6.5 Disposing the CellAED® 5.1 The CellAED® 03 SYMBOLS USED IN THIS MANUAL / DEVICE 5.2 Capabilities and key features 07 HOW TO USE THE CellAED® 5.2.1 Accessories 04 SAFETY INFORMATION 7.1 Pad placement and chest compression CPR 5.2.2 Simple Snap…Peel…Stick® operation 18 for patients weighing greater than 10 kg 4.1 Responsibility of user and training 5.2.3 Automated operation (22 lbs) requirements 5.2.4 Continuous battery diagnostic...
  • Page 3 7.3 What happens when I activate Step 1 Assess safety of location 10.2 Technical characteristics & specifications the CellAED® Step 2 Determine whether the infant 10.3 Biphasic exponential waveform 7.4 Responding to a sudden cardiac arrest using is in sudden cardiac arrest 10.4 ECG interpretation & performance the CellAED® on a patient weighing greater Step 3 Call emergency services 10.5 Guidance & manufacturer’s declaration – than 10 kg (22 lbs) immediately and retrieve the CellAED® 40 Electromagnetic emissions & immunity Step 1 Assess safety of location Step 4 Start chest compression CPR 10.5.1 Electromagnetic emissions Step 2 Determine whether the Step 5 Prepare the Infant for 10.5.2 Electromagnetic immunity patient is in sudden cardiac arrest treatment with the CellAED® 10.6 Recommended separation distance between Step 3 Call emergency services Step 6 Remove the CellAED® portable and mobile RF communications immediately and retrieve the CellAED® 35...

  • Page 4: Operating Instruction Manual Information

    OPERATING INSTRUCTIONS MANUAL INFORMATION Read the Operating Instructions carefully before 1.2 SOFTWARE LICENSE STATEMENT Neither the name of the copyright holder nor the using the CellAED® and keep it for future reference. names of its contributors may be used to endorse STM32 HAL Library is Copyright © ST Micro. or promote products derived from this software All Rights Reserved. This piece of software is made without specific prior written permission. available under the terms of the BSD Style license, 1.1 NOTICE THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS which can be found below. AND CONTRIBUTORS “AS IS” AND ANY EXPRESS OR IMPLIED It is not permitted to reproduce or duplicate this WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED CMSIS Arm Library is Copyright © ARM Limited. manual in any part without the permission of RRR WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A All Rights Reserved. This piece of software is made...

  • Page 5: Regarding This Manual

    1.3 REGARDING THIS MANUAL CellAED® due to a defect in its design or manufacture. the Claim to RRR (including any electronic records created by the CellAED® of the event involved in This indemnity does not extend to, or cover, any claim The contents of this manual are subject to change the Claim) for analysis of the cause of any failure, or legal action for liability or damages in connection without notice. All efforts have been made to ensure and providing to RRR and its counsel all other with the use of the Purchaser’s CellAED® caused by: that the contents of this manual are correct. If for evidence relevant to the Claim, whether in the form any reason the user suspects an error, please do not - Negligent operation of the CellAED®, or failure of documents or testimony. RRR will promptly hesitate to contact RRR at the address shown on to follow the sequential operating instructions for notify the Purchaser in writing if RRR determines Section 12, page 69. use of the CellAED®, or: that the Claim is not covered by this indemnity, and RRR shall have the unrestricted authority to defend 1.4 LIMITS TO MANUFACTURER’S - Failures or malfunctions of the CellAED® that are or settle any Claims for which indemnification is due to improper maintenance, including, without RESPONSIBILITIES required by this agreement. However, the Purchaser limitation, malfunctions of electrode pads or shall retain the right to participate, at its own RRR Manufacturing Pty Ltd. is not responsible...

  • Page 6: Glossary

    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 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. American Medical Association Irregular gasping or labored breathing, accompanied by strange vocalizations and involuntary, irregular (lacking rhythm) Agonal breathing muscle spasms that resemble seizures. Cardiac arrest The termination of the heart’s pumping action, resulting in lack of heartbeat, pulse and/or normal breathing.
  • Page 7 European Union Chaotic activity of the heart’s electrical system. This condition can occur in the atria or the ventricles. When it occurs in the Fibrillation 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 Heart attack confused with cardiac arrest. Light emitting diode Non-shockable rhythm A heart rhythm that is detected by the CellAED® that does not need a shock, but may need CPR. The rhythm that originates from the heart’s natural pacemaker and describes the characteristic rhythm of the healthy human Normal sinus rhythm (NSR) heart. The rate in NSR is generally regular but will vary depending on autonomic inputs into the heart’s natural pacemaker. Patient In this manual, the person suffering from sudden cardiac arrest. RRR Manufacturing Pty Ltd Shockable rhythm A heart rhythm that is detected by the defibrillator as requiring a shock, for example, ventricular fibrillation. SCA is usually caused by an electrical malfunction in the heart’s electrical system, which causes the heart to stop pumping Sudden cardiac arrest (SCA) effectively, restricting blood flow to the body. Ventricular fibrillation (VF) A life-threatening, chaotic heart rhythm originating in the ventricle. Ventricular tachycardia (VT) A life-threatening, rapid heart rhythm originating in the ventricle.

  • Page 8: Symbols Used In This Manual / Device

    SYMBOLS USED IN THIS MANUAL / DEVICE SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION RRR MANUFACTURING PTY LTD 2- 6 Skinner Road Riverwood NSW 2210 AUSTRALIA Manufacturer ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements) ISO 7000-3082 — Graphical symbols for use on equipment. Date of Manufacture ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and (yyyy-mm-dd) information to be supplied — Part 1: General requirements (5.1.3) Mdi Europa GmbH Langenhagener Str. 71 Authorised Representative D-30855 Langenhagen in the European Community ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (5.1.2)
  • Page 9 SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION Hereby, RRR Manufacturing Pty Ltd declares that the CellAED® meets the provision of the following CE marking and Notified Union harmonisation legislation: Council Directive 93/42/EEC, Radio Equipment Directive 2014/53/ Body Number related to EU (radio equipment type class 1), RoHS Directive 2011/65/EU. The full text of the EU declaration of CE conformity conformity is available at the following internet address: www.rapidresponserevival.com/declaration- of-conformity ISO 15223-1, Clause 5.1.6 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied Catalogue or model number ISO 7000- 2493 — Graphical symbols for use on equipment ISO 15223-1, Clause 5.1.7 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Serial number ISO 7000-2498 — Graphical symbols for use on equipment. Refer to Operating ISO 7010-M002 — Refer to instruction manual / booklet Instruction Manual / Booklet...
  • Page 10 SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION Caution: Read all warnings and precautions in ISO 15223-1, Clause 5.4.4 Medical devices — Symbols to be used with medical device labels, labelling instructions for use. Refer and information to be supplied. to the Section about IEC 60601-1-11:2015, Table D.1, Symbol 10 Medical electrical equipment — Part 1: General requirements General Warnings, Alerts for basic safety and essential performance. and Cautions for more ISO 7000-0434 — Graphical symbols for use on equipment. information about the warnings and cautions. ISO 7000 — Graphical symbols for use on equipment — Registered symbols.
  • Page 11 SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION Do not open until ISO 7010 - Graphical symbols, safety colours and safety signs. ready for use ISO 15223-1, Clause 5.4.2 Medical devices — Symbols to be used with medical device labels, labelling Do not re-use and information to be supplied. ISO 7000-1051 — Graphical symbols for use on equipment. Separate collection for EN 50419 — Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of waste of electrical Directive 2002/96/EC (WEEE). Recycle: Electronic Equipment DO NOT THROW IN TRASH. and electronic equipment 35°C Indicates the temperature limits to which the medical device can be safely exposed. (95°F) ISO 15223-1, Clause 5.3.7 Medical devices — Symbols to be used with medical device labels, labelling Storage temperature range and information to be supplied.
  • Page 12 SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION ISO 15223-1, Clause 5.3.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Keep dry ISO 7000-0626 — Graphical symbols for use on equipment. A potential or actual hazard EN 60601-1-11 : 2015 exists. Warning, high voltage IEC 60417. Committee: IEC/SC 3C. Type BF applied part. Reference number: 5333. Type: For use on Type BF applied part equipment. ISO 15223-1, Clause 5.4.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Consult Instructions for Use 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/patents Logo RRR Worldmark Logo...
  • Page 13 SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION Visually represents the action required to activate the CellAED®. The CellAED® is separated along the SNAP 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 PEEL by separation of the two halves of the CellAED®, exposing the adhesive gel pads and extending the electrical connecting cable. Visually represents the activation process of the CellAED®. Audio (voice) prompts instruct the user to STICK apply the electrode gel pads of the CellAED® to the patient appropriately. A two-digit number established by the International Electro Technical Commission, is used to provide an (Enclosure) Protected from Ingress Protection rating to a piece of electronic equipment or to an enclosure for electronic equipment. tools & wires greater than 2.5 The protection class after EN60529 are indicated by short symbols that consist of the two code millimeters & water spray less letters IP and a code numeral for the amount of the protection. than 15 degrees from vertical Class IIb Medical Electrical Indicates and refers to the level of electrical isolation provided by the part.
  • Page 14 SYMBOLS DESCRIPTION RELATIVE SYMBOL REGULATIONS AND MORE INFORMATION Electromagnetic Interference may occur in the vicinity of equipment. Interference ISO 15223-1, Clause 5.1.5 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Batch code ISO 7000-2492 — Graphical symbols for use on equipment. ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (5.1.4) Indicates the date after which the Use-by Date as medical device is not to be used. yyyy-mm-dd ISO 7000-2607 — Graphical symbols for use on equipment. Do not use if package is ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (5.2.8) damaged ISO 15223-1, Clause 5.3.1 Medical devices — Symbols to be used with medical device labels, labelling Fragile, handle with care 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.

  • Page 15: Safety Information

    SAFETY INFORMATION This Section provides important information to chest compression cardiopulmonary resuscitation may result in harm to the patient or user. (CPR) until Emergency Services arrive. help you safely operate your CellAED®. Familiarise All potential users of the CellAED® should read this yourself with safety terms (Danger, Warning and User Manual and view the CellAED® Instructional 4.2.1 WHAT IS SUDDEN Caution) in this Section. videos (accessible by scanning the QR code on the CARDIAC ARREST (SCA)? back of the outer packaging (Figure 3B, page 25) and protective case (Figure 4A, page 26).

  • Page 16: Cellaed® Indications For Use

    4.4 CellAED® CONTRAINDICATIONS restore the heart’s electrical function to a normal minor personal injury to the user and/or the patient, sinus rhythm (NSR). The CellAED® will then instruct product damage, or property damage. The CellAED® must not be used if a person is: the user to commence chest compression CPR for 2 Please refer to Section 11, pages 64 - 68. • Responsive, minutes. If a shockable heart rhythm is not detected, the CellAED® will not deliver a shock and will 4.6 OPERATION WITH OTHER DEVICES • Conscious, or instruct the user to commence chest compression The CellAED® may cause interference with other...

  • Page 17: Terms Of Warranty

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

  • Page 18: About Cellaed

    5.2 CAPABILITIES AND KEY FEATURES ABOUT CellAED® The following paragraphs introduce specific key features found in the CellAED®. The CellAED® conforms to all mandatory clinical The CellAED® will only administer defibrillation requirements in compliance with EN 60601-2- when the heart exhibits VF and VT, as these are the 5.2.1 ACCESSORIES heart rhythms associated with SCA. The CellAED® 4:2011+A1:2019 and EN 60601-1-11:2015. will not administer an electrical shock if it detects a The unit complies with all relevant standards for No accessories provided.

  • Page 19: Continuous Battery Diagnostic

    A blinking AMBER LED (every 30 seconds) indicates Maintaining the CellAED® in an ideal storage condition audio (voice) prompt invites them to “For infants, press that the battery is low and the CellAED® should be (15°C – 35°C (59°F – 95°F)) is required to maximise infant button.” The user must press the infant button replaced immediately. the performance of the battery as well as the a second time to confirm and enable Infant Mode. CellAED® expected shelf life (refer to Section 6.4, No LED indicates that the battery has expired and The CellAED® will issue audio prompt warnings prior page 28). the CellAED® should be replaced immediately. to shock delivery. Shock delivery is automated by the CellAED®. 5.2.5 HEART RHYTHM ANALYSIS If the patient is transferred to emergency medical The CellAED® evaluates the patient’s heart rhythm. personnel, the medical personnel can remove the Refer to Section 10.4, page 57 (ECG Interpretation CellAED® electrode pads and replace with their own and Performance) for further information.

  • Page 20: Shelf Life

    GETTING STARTED The CellAED® package contains: 2. Open the outer packaging and remove the 4. Save the outer packaging and any inserts in case protective case. Check that the tamper evident the CellAED® requires transporting in the future. - One CellAED® single-use automated external seal (Figure 1 (b), page 21) on the protective case defibrillator Contact RRR with any questions about the has not been broken. Do not remove the tamper CellAED® (Section 12, page 69). - This is sealed inside a transparent bag and a evident seal, and do not remove the CellAED®...
  • Page 21 (b) Tamper evident seal (a) CellAED® (c) Protective case FIGURE 1B: Opening the tamper seal (e) Operational instructions (d) Sealed transparent bag FIGURE 1: CellAED® protective case front (Continued page 22)

  • Page 22: Packaging, Instructions, Controls, Indicators And Labels

    2B, page 23). These WARNINGS should only be torn open when the CellAED® will be used. The outer packaging box (Figure 3B, page 25) and protective case (Figure 4A, page 26) feature storage Each CellAED® has a unique Serial Number (SN) and handling instructions, warnings, and the Date (Figure 5 (g), page 34). Each CellAED® also has a of Manufacture/ Use-by Date of the CellAED® on Unique Device Identification number (UDI) (Figure the back. QR codes (Figure 3B, page 25 and Figure 4A (a), page 26). The UDI is the combination 4A (b), page 26) provide online access to a PDF of of the Global Trade Item Number (GTIN), the the Operating Instructions, and step-by-step video manufacturing date, the expiry date, the batch instructions for responding to a patient in SCA.
  • Page 23 Back liner label FIGURE 2A: CellAED® sealed transparent bag front FIGURE 2B: CellAED® sealed transparent bag back...
  • Page 24 AUTOMATED EXTERNAL DEFIBRILLATOR SINGLE-USE AED SNAP PEEL STICK FIGURE 3A: CellAED® outer box front...
  • Page 25 QR codes FIGURE 3B: CellAED® outer box back...
  • Page 26 INFAN THAN 1 (a) UDI Label CellAED Operat ® CellAED Instru ® (b) QR codes yyyy-mm-dd 0000111122223333 FIGURE 4A: CellAED® protective case back & side Designed & manufac...
  • Page 27 FIGURE 4B: CellAED® protective case inside...

  • Page 28: Storing The Cellaed

    CellAED® near other emergency equipment, such as (59° - 95°F). Temperatures exceeding 35°C (95°F) fire extinguishers and first-aid kits. can permanently damage the internal battery. 3. The LED on the front of the CellAED® (Figure 5 Position the CellAED® so that the LED Indicator (e), page 34): 6.4 MAINTAINING THE CellAED® (Figure 5 (e), page 34) on the front of the CellAED® - A blinking GREEN LED (every 30 seconds) The CellAED® does not require routine maintenance. is easy to see. indicates that the CellAED® is fully operational Plan a monthly inspection of the CellAED® to check: and ready to use. DANGER: Do not store or use the CellAED® near 1. That the current date is within the use by period - A blinking AMBER LED (every 30 seconds)
  • Page 29 An example of an Inspection Record as shown: PRODUCT INSPECTION CHECKLIST FOR USERS Serial Number 00112233445566 Date of Manufacture yyyy-mm-dd Date of Inspection yyyy-mm-dd Use-by Date yyyy-mm-dd ■ Good Package Condition ■ Damage or rips or cracks* ■ None present Foreign Substances ■ Oil, dirt, dust present* ■ LED blinks GREEN ■ LED blinks AMBER* LED indicator Replace the CellAED® immediately ■ Accessible Useful items ■ Not accessible * Dispose of the CellAED® safely and immediately according to local council regulations.
  • Page 30 DANGER: Damaged or expired equipment or As with all batteries, this battery will decay over accessories may result in ineffective treatment, or time due to its natural self-discharge. Exposure to user injury. temperatures outside of the specifications of the CellAED® may permanently increase the self- The CellAED® may be damaged by mechanical discharge rate of the battery, which can ultimately or physical abuse, such as immersion in water or lead to a significant reduction in the expected shelf dropping the CellAED®. Avoid spilling any fluids on life of the battery and the CellAED® accordingly. the CellAED® enclosure or its electrode pads. Do not clean with ketones or other flammable agents. In Users are strongly encouraged to perform a regular case of physical or mechanical abuse, dispose of the inspection of their CellAED® and maintain a record CellAED® safely and immediately according to local of this. An example of an inspection record is also council regulations. provided on page 29. 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 rucial 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 non-rechargeable battery provided with the CellAED® has an estimated shelf life of 13 months.

  • Page 31: Disposing The Cellaed

    6.5 DISPOSING OF THE CellAED® regulations for disposing of batteries and electrical/ electronic waste. Correct disposal procedure The CellAED® is designed to be used once and according to local council regulations must be then disposed of safely and immediately after use, observed to ensure that no dangerous substances are according to local council regulations. released, which may adversely impact human and/or The single use battery embedded in the CellAED® environmental health. has a shelf life of no longer than 13 months from the Where applicable, follow Directive 2012/19/EU of the date of manufacture; When the battery is low, the European Parliament Policy for Waste Electrical and LED will blink AMBER to indicate the need to replace Electronic Equipment (WEEE). If no collection point the CellAED®. or recycling centre is available, return the CellAED® to the nearest distributor or the manufacturer. DANGER: The CellAED® battery is not rechargeable. Do not attempt to recharge, open, crush, or burn the WARRANTY: The Manufacturer provides a Warranty battery, as these actions present a risk of explosion for the battery and therefore for the CellAED® for a or fire and can cause harm to the user. If the battery period of 13 months from the date of manufacture. is depleted, the CellAED® needs to be replaced. For more details, please refer to Section 4.7 (Terms Dispose of the CellAED® safely and immediately of Warranty, page 17).

  • Page 32: How To Use The Cellaed

    HOW TO USE THE CellAED® The CellAED® is designed to enable any operator treatment. Activate the CellAED® Infant Mode by to deliver chest compressions to a depth of no more to perform defibrillation in the event of SCA, than one third of the patient’s chest cavity. pressing the Infant Mode Button when prompted by prior to arrival of Emergency Services. The use of the audio (voice) prompts (Figure 5 (d), page 34) 7.2 PAD PLACEMENT AND CHEST the CellAED® involves a three-step process, as only for infants that weigh less than 10 kg (22 lbs), or COMPRESSION CPR FOR INFANTS illustrated in Figure 5 (page 34): typically less than 1 year old. WEIGHING LESS THAN 10 kg (22 lbs) 1.

  • Page 33: Responding To A Sudden Cardiac Arrest Using

    (refer to pads to be applied to the patient’s skin. Figures 16A and 16B, pages 46-49). 7.4 RESPONDING TO A SUDDEN CARDIAC iv) If the patient weighs less than 10 kg (22 lbs), ARREST USING THE CellAED® ON A WARNING: Do not handle or transport the patient press the infant button (Figure 5 (d), page PATIENT WEIGHING GREATER THAN 10 kg while the CellAED® is attached to the patient 34) when prompted. Press the infant button...

  • Page 34: (22 Lbs)

    10 kg (22 lbs) (d) Press button for defibrillation of infants weighing less than 10 kg (22 lbs) LED indicator (f) Audio speaker (g) Serial Number FIGURE 5: CellAED® enclosure with cues for action...

  • Page 35: Step 1 Assess Safety Of Location

    STEP 4 START CHEST COMPRESSION CPR Ensure that no obvious danger is present, and that Start chest compression CPR to keep the patient’s the area is safe for you to provide chest compression blood flowing. To perform chest compression CPR CPR and administer the CellAED®. FIGURE 6: Check if the patient is responsive on a patient weighing greater than 10 kg (22 lbs) (Figure 7, page 36), complete the following: DANGER: Do not use the CellAED® while the patient is i) Place the heel of one hand over the sternum, CALL EMERGENCY SERVICES in or is near a pool of water or on any other conductive in the centre of the patient’s chest. Place your STEP 3 IMMEDIATELY AND RETRIEVE THE surface(s). Carefully remove the patient if necessary. Ensure that the patient is dry before using the CellAED®. CellAED®...

  • Page 36: Step 5 Prepare The Patient For

    FIGURE 7: Chest compression CPR Continue to provide chest compression CPR. If the patient remains unconscious, unresponsive, or If possible, call for assistance as you prepare not breathing normally after 60 seconds, obtain the PREPARE THE PATIENT FOR the CellAED® for use. CellAED® and prepare the patient for treatment. STEP 5 TREATMENT WITH THE CellAED® - Remove clothing and jewellery and expose the patient’s chest (Figure 8, page 36). The CellAED® has been designed for use on people who are unconscious, unresponsive, and who - Shave any excessive hair in the areas where you have ceased breathing or have abnormal (agonal) will place the pads. breathing associated with SCA. - If the chest is dirty or moist, wipe the chest with a towel to make the skin dry and clean for good DANGER: Do not store or use the CellAED® near flammable gases (such as in an oxygen-enriched pad contact.

  • Page 37: Step 6 Remove The Cellaed® From The Packaging

    REMOVE THE CellAED® FROM THE STEP 6 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… STICK® actions as shown in Figure 9, page 37. i) Hold the CellAED® with two hands with the FIGURE 9: Instructions for patients weighing greater than 10 kg (22 lbs) label side facing up and side featuring ‘THIS...
  • Page 38 - The patient recovers and is breathing normally, or DO NOT TOUCH PATIENT, followed by STAND pad contact with the skin is critical (refer - Qualified medical help is ready to take over, or CLEAR FOR SHOCK. Do not touch the patient when to Figure 9, page 37 for patients weighing - A healthcare professional instructs you to stop, or these prompts are heard and whilst the red LED greater than 10 kg (22lbs)). - It is physically impossible to continue. is illuminated. The CellAED® will advise when to WARNING: Air pockets between the skin commence chest compression CPR. - The CellAED® advises the user to stop chest and electrode pads can cause ineffective compression CPR. WARNING: The energy emitted by the CellAED® treatment. Make sure electrode pads are If the patient starts moving, coughing, or breathing can be conducted through the patient or conductive completely adhered to the skin. If necessary regularly, place the patient in the recovery position matter touching the patient. Therefore: and possible, shave hair from the area to (Figure 10, page 39) and keep them as still as - Do not touch the patient, electrode pads, metal ensure good contact. Do not use damaged,...
  • Page 39 FIGURE 10: Move patient into recovery position (Continued page 40)

  • Page 40: Responding To A Sudden Cardiac Arrest Using The Cellaed® On An Infant Weighing Less Than 10 Kg (22 Lbs)

    7.5 RESPONDING TO A SUDDEN CARDIAC CALL EMERGENCY SERVICES AND i) Place 2 fingers over the sternum, in the centre STEP 3 ARREST USING THE CellAED® ON AN RETRIEVE THE CellAED® of the patient’s chest. INFANT WEIGHING LESS THAN 10 kg (22 lbs) ii) Press straight down on their chest and deliver If the infant is unconscious, unresponsive, and not breathing normally, or if you are unsure whether chest compressions of no more than one third STEP 1 ASSESS SAFETY OF LOCATION they are in SCA, remain with the infant and call or of the infant’s chest cavity.

  • Page 41: From The Packaging

    FIGURE 11: Check if infant is FIGURE 12: Chest compression FIGURE 13: Expose chest for If the infant remains unconscious, unresponsive, or responsive or normal breathing defibrillation not breathing normally after 60 seconds, obtain the CellAED® and prepare the infant for treatment. REMOVE THE CellAED® FROM THE WARNING: Certain materials making contact STEP 6 - Remove clothing and jewellery and expose the PACKAGING with the electrode pads during defibrillation can infant’s chest (Figure 13, page 41). cause electrical sparks, skin burns, and divert...

  • Page 42: Step 7 Defibrillate Using The Cellaed

    STEP 7 DEFIBRILLATE USING THE CellAED® To activate the CellAED®, perform the SNAP…PEEL… STICK® 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 FIGURE 14: Instructions for infants less than 10 kg (22 lbs) SIDE FACE DOWN’. It should be completely...
  • Page 43 - Do not use the CellAED® when the patient is If the infant starts moving, coughing, or breathing the infant button a second time to confirm and in or is near a pool of water or on any other regularly, place the infant in the recovery position conductive surface(s). Carefully remove the patient (Figure 15, page 43) and keep them as still as enable INFANT MODE. if necessary. Ensure the patient is dry before using possible until Emergency Services arrive. ix) Follow the audio (voice) prompt instructions the CellAED®. as directed and do not touch the infant unless CAUTION: Temporary redness of the skin may occur When the audio (voice) prompts to begin chest instructed to do so. where the electrodes were attached. This is not compression CPR is heard, remove the front electrode concerning unless the infant experiences pain, in If the CellAED® heart rhythm analysis determines pad and set aside carefully. The CellAED® will issue which case inform the infant’s healthcare provider so that a shock is needed, the audio (voice) prompt an audio metronome to guide the chest compression that the infant can receive the appropriate care. will announce SHOCK ADVISED and then instruct rate. Replace the front pad for heart rhythm analysis DO NOT TOUCH PATIENT, followed by STAND when instructed. When finished using the CellAED®, stick the gel side CLEAR FOR SHOCK. Do not touch the patient when of the pads together for at least five seconds. This...

  • Page 44: Voice Prompt Instructions

    10 kg (22lbs) and Figure 14 (page 42) for infants weighing less than 10 kg (22lbs)). FOR INFANTS, PRESS INFANT For infants weighing less than 10 kg (22 lbs) (typically less than 1 year old), press the infant button (Figure 5(d), page 34) BUTTON within 5 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 For infants weighing less than 10 kg (22 lbs) (typically less than 1 year old), press the infant button (Figure 5(d), page 34) CONFIRM INFANT MODE 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.
  • Page 45 SHOCK NOT ADVISED The CellAED® has not detected a shockable rhythm (VF or VT). No operator or user action is required. SHOCK ADVISED The CellAED® has detected a shockable rhythm (VF or VT) and that 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. STAND CLEAR FOR SHOCK 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. SHOCK DELIVERED The CellAED® has discharged an electric shock to the patient. No operator or user action is required. BEGIN CPR 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 CPR Continue chest compression CPR at the rate provided by the audio metronome. STOP CPR Stop performing chest compression CPR. DEVICE DEACTIVATED The CellAED® has been deactivated. Carefully set aside and dispose of the CellAED® safely and immediately, according to...
  • Page 46 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) “Shock not advised” “Begin CPR” SNAP PEEL STICK If no shockable rhythm If shockable rhythm “Call for help”...
  • Page 47 CellAED® Continue CPR for SHOCK deactivated. 2 minutes or until Dispose of the If pads together help arrives or DELIVERED CellAED® safely patient recovers and immediately. “Continue CPR” “Device deactivated” “Stand clear for shock” “Shock delivered” “Begin CPR” “Stop CPR”...
  • Page 48 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” "For infants, press "Analysing heart rhythm" “Do not touch patient”...
  • Page 49 Continue CPR for SHOCK deactivated. 2 minutes or until Dispose of the If pads together help arrives or DELIVERED CellAED® safely patient recovers and immediately. “Shock advised” “Do not touch patient” “Continue CPR” “Device deactivated” “Stand clear for shock” “Shock delivered”...

  • Page 50: Troubleshooting

    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 RRR directly or through an authorised dealer about any malfunction of a CellAED®. PROBLEM...
  • Page 51 WHAT TO DO Electrode pads are not Poor surface preparation Clean, shave, and dry the patient’s skin. adhering to the patient Electrode pads expired 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 nearest distributor. Dispose of the CellAED® safely and immediately according to local council regulations. Audio (voice) prompt Poor pad contact to patient Clean, shave, and dry the patient’s skin. to apply pads to patient Poor surface preparation Firmly press the pads on the patient’s bare skin. Ensure that the entire pad adheres to the patient’s is continuing, after the skin. operator has applied pads...

  • Page 52: Technical Specifications And Information

    TECHNICAL SPECIFICATIONS AND INFORMATION 10.1 TECHNICAL TERMINOLOGIES/ACRONYMS TERMINOLOGY/ ACRONYMS DESCRIPTION Acrylonitrile Butadiene Styrene EIRP Effective Isotropic Radiated Power Electromagnetic Interference Emergency Medical Services Electrostatic Discharge International Electrotechnical Commission Impedance Resistance to the flow of electrical current Ingress Protection International Organization for Standardisation ISTA International Safe Transit Association Joule (J) The basic unit of energy delivered by a defibrillator. The amount of energy delivered during defibrillation in Watt-seconds MIL-STD Military Standard Radio Frequency Radio Frequency Interference Specific Absorption Rate...

  • Page 53: Technical Characteristics & Specifications

    10.2 TECHNICAL CHARACTERISTICS AND SPECIFICATIONS GENERAL SPECIFICATIONS SHELF LIFE 13 months from date of manufacture ENCLOSURE ABS/Polycarbonate fire retardant blend DIMENSIONS (W X D X H) 196 mm x 93 mm x 17 mm WEIGHT Approximately 300 g BATTERY 12.0 V, 900 mAh, non-rechargeable LiMnO FIRMWARE VERSION 1.0.3 PERFORMANCE SPECIFICATIONS NUMBER OF MAXIMUM ENERGY SHOCKS DELIVERED BY A NEW BATTERY > 70 shocks NUMBER OF MAXIMUM ENERGY SHOCKS DELIVERED WHEN LOW BATTERY EVENT OCCURS > 3 shocks PRE-PROGRAMMED MAXIMUM NUMBER OF SHOCKS 20 shocks...
  • Page 54 CLASSIFICATION OF MEDICAL ELECTRICAL EQUIPMENT EQUIPMENT CLASSIFICATION Class IIb Internally Powered Type BF medical device. CONFORMITY Directive 93/42/EEC CellAED® INGRESS PROTECTION IP 22 MODE OF OPERATION Continuous, infrequent single event use only ELECTRODE SPECIFICATIONS ELECTRICAL CONNECTING CABLE 1 m, 28 AWG CONTACT AREA Total combined area: 166 cm 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 15 ºC to 35 ºC (59 ºF to 95 ºF), 0% to 95% RH (relative humidity) (non-condensing)
  • Page 55 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 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 EU Directive 2015/863 SUBSTANCE DIRECTIVE (RoHS) 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 10993-1:2009/AC:2010 TRANSPORTATION ANSI ISTA Procedure 3A...

  • Page 56: Biphasic Exponential Waveform

    The waveform is automatically PATIENT WEIGHING GREATER THAN 10 kg (22 lbs) adjusted to compensate for IMPEDANCE (Ω) ENERGY (J) PEAK I (MS) PEAK I (MS) patient impedance. 1050 42.0 1005 40.2 The CellAED® does not detect patient motion. 1150 23.0 1120 22.4 1183 15.8 14.2 1166 15.6 1204 12.0 18.8 1190 11.9...

  • Page 57: Ecg Interpretation & Performance

    10.4 ECG INTERPRETATION AND PERFORMANCE When placed on a patient meeting the indication SENSITIVITY AND SPECIFICITY OF RHYTHM RECOGNITION DETECTOR for use criteria, the CellAED® is designed to recommend a defibrillation shock when it detects Meets IEC/EN 60601-2-4 requirement proper pad impedance and one of the following Shockable Rhythm – VF...

  • Page 58: Electromagnetic Emissions

    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...

  • Page 59: Electromagnetic Immunity

    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. IEC 60601-1-2:2014/EN 60601- IMMUNITY TEST 1-2:2015 COMPLIANCE LEVEL...

  • Page 60: Recommended Separation Distance Between

    IEC 60601-1-2:2014/EN 60601- IMMUNITY TEST 1-2:2015 COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT TEST LEVEL Radiated RF EM Fields IEC 61000-4- 10 V/m, 20 V/m 80MHz to 2.5GHz 10V/m Portable and mobile RF communications 3:2006/ A1:2007+A2:2010 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 following symbol above. (Continued page 61)
  • Page 61 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.
  • Page 62 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®...
  • Page 63 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.

  • Page 64: Dangers, Warnings & Cautions

    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 immediate hazards that will result in 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. DANGERS Flammable gas 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. Battery 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. Fluids Avoid spilling any fluids on the CellAED® enclosure or its electrode pads. Do not clean the CellAED® with ketones or other flammable agents.
  • Page 65 Use of the CellAED® 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. 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. Patient handling 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.
  • Page 66 Children Store out of reach of children and pets. Keep a snapped CellAED® out of the reach of children as the cable presents a risk of strangulation. A snapped CellAED® should be disposed of safely and immediately after use according to local council regulations. Modification of the Do not attempt to service or modify the CellAED®. The unit is not intended for maintenance or service by the user. Modifying the CellAED® 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. Single-use The CellAED® is a single-use device and cannot be re-used or recycled. Never use a compromised, damaged, expired, or pre-used CellAED®, as doing so may result in ineffective treatment or user injury. Dispose of the CellAED® safely and immediately after use according to local council regulations. WARNINGS Temperature 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. Electrical energy The CellAED® delivers up to 85 Joules of electrical energy with every shock delivery. Mishandling the CellAED® may cause serious injury. Do not insert any object into the CellAED®.
  • Page 67 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. CAUTION Storage Store the CellAED® out of reach of pets or children. Electromagnetic The normal operation of the CellAED®, including the ability to correctly detect a shockable rhythm, may be impacted if it is operated Interference and near strong sources of electromagnetic interference (EMI) and/or radio frequency interference (RFI). This can include arc welders and Radio Frequency 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). Interference...
  • Page 68 Packaging 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. If this occurs, the CellAED® should be disposed of safely and immediately according to local council regulations. Use of the CellAED® 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. Disposal After the CellAED® has been used, is expired, is damaged, or you have doubts about the condition of the CellAED®, dispose of it safely and immediately according to the local council regulations for disposing of batteries and electrical/electronic waste. Correct disposal procedure according to local council regulations must be observed to ensure that no dangerous substances are released, which may adversely impact human and/or environmental health.

  • Page 69: Contacts

    CONTACTS EU Representative Mdi Europa GmbH EC REP Langenhagener Str. 71 D-30855 Langenhagen Germany Manufacturer RRR MANUFACTURING PTY LTD 2 - 6 Skinner Avenue, Riverwood, NSW 2210 Australia +61 1300 727 580 www.rapidresponserevival.com info@rapidresponserevival.com 2.2CAED.P.IFU.110002 Rev .04 Publication date: 30/11/2020...

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