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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

C to 35

C (32

F to 95

F), 0% to 95% RH (relative humidity) (non-condensing)

STANDBY/STORAGE CONDITIONS

C to 35

C (59

F to 95

F), 0% to 95% RH (relative humidity) (non-condensing)

TRANSPORT CONDITIONS

C to 35

C (32

F to 95

F), 0% to 95% RH (relative humidity) (non-condensing)

ALTITUDE

-100 m to 4,000 m

ATMOSPHERIC PRESSURE

60 kPa to 102 kPa

Содержание CellAED

Страница 1: ...SINGLE USE AED 2 USER MANUAL PEEL SNAP STICK SINGLE USE AUTOMATED EXTERNAL DEFIBRILLATOR Read the User Manual carefully before using the CellAED and keep it for future reference...

Страница 2: ...ty terms 16 4 6 Operation with other devices 16 4 7 Terms of Warranty 17 4 8 More Information 17 05 ABOUT CellAED 18 5 1 The CellAED 18 5 2 Capabilities and key features 18 5 2 1 Accessories 18 5 2 2...

Страница 3: ...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 CP...

Страница 4: ...in 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 di...

Страница 5: ...ot 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...

Страница 6: ...rmination 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 defibrillato...

Страница 7: ...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 pacemak...

Страница 8: ...phical symbols for use on equipment Date of Manufacture yyyy mm dd ISO 15223 1 2016 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 Genera...

Страница 9: ...rmity is available at the following internet address www rapidresponserevival com declaration of conformity Catalogue or model number ISO 15223 1 Clause 5 1 6 Medical devices Symbols to be used with m...

Страница 10: ...formation 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...

Страница 11: ...le 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...

Страница 12: ...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 t...

Страница 13: ...vation 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 mi...

Страница 14: ...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...

Страница 15: ...ng 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...

Страница 16: ...You may encounter the following terms throughout this manual and while using the CellAED Danger Immediate hazards that will result in serious personal injury or death to the user and or the patient Wa...

Страница 17: ...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...

Страница 18: ...thms 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...

Страница 19: ...s visual feedback to indicate the state of readiness A blinking GREEN LED every 30 seconds indicates the CellAED is fully operational and ready to use A blinking AMBER LED every 30 seconds indicates t...

Страница 20: ...heck the Date of Manufacture Use by Date on the back side of protective case Figure 4A page 26 Confirm that the current date is within 13 months of the manufacturing date The CellAED expires 13 months...

Страница 21: ...21 Continued page 22 FIGURE 1B Opening the tamper seal c Protective case b Tamper evident seal e Operational instructions a CellAED d Sealed transparent bag FIGURE 1 CellAED protective case front...

Страница 22: ...case details additional environmental and operational safety requirements and features a tamper evident seal Figure 1 b The CellAED operational label as seen through the transparent bag and front of...

Страница 23: ...23 FIGURE 2A CellAED sealed transparent bag front FIGURE 2B CellAED sealed transparent bag back Back liner label...

Страница 24: ...SINGLE USE AED AUTOMATED EXTERNAL DEFIBRILLATOR PEEL SNAP STICK 2 24 FIGURE 3A CellAED outer box front...

Страница 25: ...25 FIGURE 3B CellAED outer box back QR codes...

Страница 26: ...26 FIGURE 4A CellAED protective case back side b QR codes SN 0000111122223333 yyyy mm dd Designed manufac CellAED Instru CellAED Operat INFAN LES THAN 1 a UDI Label...

Страница 27: ...27 FIGURE 4B CellAED protective case inside...

Страница 28: ...nently damage the internal battery 6 4 MAINTAINING THE CellAED The CellAED does not require routine maintenance Plan a monthly inspection of the CellAED to check 1 That the current date is within the...

Страница 29: ...HECKLIST FOR USERS Serial Number 00112233445566 Date of Manufacture yyyy mm dd Date of Inspection yyyy mm dd Use by Date yyyy mm dd Package Condition Good Damage or rips or cracks Foreign Substances N...

Страница 30: ...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...

Страница 31: ...ter use dispose of the CellAED safely and immediately according to local council regulations CAUTION After the CellAED has been used is expired is damaged or you have doubts about the condition of the...

Страница 32: ...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...

Страница 33: ...mits 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 s...

Страница 34: ...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 FIGURE 5 CellAED enclosure...

Страница 35: ...talk to me 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 th...

Страница 36: ...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 Shave any excessive ha...

Страница 37: ...ges 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...

Страница 38: ...t 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 s...

Страница 39: ...39 Continued page 40 4 2 3 1 FIGURE 10 Move patient into recovery position...

Страница 40: ...one 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 Emer...

Страница 41: ...quipment 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 sk...

Страница 42: ...dy 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...

Страница 43: ...ssion CPR 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...

Страница 44: ...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...

Страница 45: ...VERED 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 F...

Страница 46: ...e rhythm PRESS FOR INFANT USE ONLY 10KG PRESS FOR INFANT USE ONLY 10KG PRESS FOR INFANT USE ONLY 10KG PRESS FOR INFANT USE ONLY 10KG For adult apply pads across chest For infant apply pads to chest ba...

Страница 47: ...elp arrives or patient recovers CellAED deactivated Dispose of the CellAED safely and immediately SHOCK DELIVERED Stand clear for shock Begin CPR Shock delivered Device deactivated Voice commands If p...

Страница 48: ...Remain calm SNAP PEEL STICK For infants press infant button Press infant button to confirm Infant Mode Infant Mode enabled PRESS FOR INFANT USE ONLY 10KG Analysing heart rhythm INSTRUCTIONS FOR INFANT...

Страница 49: ...advised Do not touch patient Shock not advised Begin CPR Stand clear for shock Begin CPR Shock delivered If no shockable rhythm If shockable rhythm Device deactivated Continue CPR Stop CPR If pads to...

Страница 50: ...or Dispose of the CellAED safely and immediately according to local council regulations Peeling or damaged sealed transparent bag on visual inspection Expired CellAED Damaged CellAED Administer chest...

Страница 51: ...n 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 o...

Страница 52: ...to the flow of electrical current IP Ingress Protection ISO International Organization for Standardisation ISTA International Safe Transit Association Joule J The basic unit of energy delivered by a d...

Страница 53: ...SPECIFICATIONS 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 PROG...

Страница 54: ...ING CABLE 1 m 28 AWG CONTACT AREA Total combined area 166 cm2 ELECTRODE MATERIAL Hydrogel ELECTRODE DIMENSIONS 9 cm x 9 25 cm ENVIRONMENTAL SPECIFICATIONS OPERATING CONDITIONS 0 C to 35 C 32 F to 95 F...

Страница 55: ...MA 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 4 201...

Страница 56: ...5 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 AUDITORY ALARM VOLUME...

Страница 57: ...s 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 200 V and V...

Страница 58: ...uding industrial establishments domestic establishments and establishments directly connected to the public low voltage power supply for domestic purpose The CellAED is intended for use in the electro...

Страница 59: ...lectrostatic discharge Power frequency magnetic field IEC IEC 61000 4 8 2009 EN 61000 4 8 2009 30 A m 50Hz 30 A m 50Hz Power frequency magnetic fields should not be greater than magnitudes which are t...

Страница 60: ...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...

Страница 61: ...n 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 t...

Страница 62: ...0 12 00 23 00 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 b...

Страница 63: ...l 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 th...

Страница 64: ...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 sou...

Страница 65: ...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 us...

Страница 66: ...gency 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...

Страница 67: ...hm 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 hea...

Страница 68: ...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 ineffec...

Страница 69: ...ermany Manufacturer RRR MANUFACTURING PTY LTD 2 6 Skinner Avenue Riverwood NSW 2210 Australia 61 1300 727 580 www rapidresponserevival com info rapidresponserevival com EU Representative EC REP 2 2CAE...

Страница 70: ......

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