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Bexen REANIBEX 300 User Manual Download Page 1

 

 

 

AED/Manual Defibrillator

 

 

REANIBEX 300

 

 

 

 

 

 

USER MANUAL

 

DIH 0300 B – REV: C / 2014.FEB

 

 

Summary of Contents for REANIBEX 300

Page 1: ...AED Manual Defibrillator REANIBEX 300 USER MANUAL DIH 0300 B REV C 2014 FEB...

Page 2: ......

Page 3: ...REANIBEX 300 USER GUIDE Review Date Approved by Signature C February 2014 Gorka Landaburu R D Manager...

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Page 5: ...this manual may be modified by the manufacturer without requiring prior notice If the information in this User Guide does not correspond to the operation of the device please contact an authorised rep...

Page 6: ...Blank page...

Page 7: ...Coop Direcci n del fabricante Manufacturer s address Edificio Zearrekobuelta Subida de Areitio N 5 48260 Ermua Bizkaia SPAIN Tipo de equipo Type of equipment Desfibrilador Manual AED Defibrillator Ma...

Page 8: ...Blank page...

Page 9: ...0 3 4 CONNECTIONS FOR THE TRANSFER OF INTERNAL EQUIPMENT DATA 20 3 4 1 CONNECTING THE USB MEMORY TO THE EQUIPMENT 21 4 AUTOMATED EXTERNAL DEFIBRILLATION 22 4 1 INTENDED USE 22 4 2 WARNINGS AND PRECAUT...

Page 10: ...TEST RESULTS 49 8 5 3 LATEST EPISODE RESULTS 50 8 5 4 EPISODE DELETION 50 8 6 USB TRANSFER 51 8 6 1 TRANSFER TO USB MEMORY 51 8 6 2 TRANSFER TO A PC VIA A USB CABLE 52 8 7 TESTS 52 8 7 1 HARDWARE TES...

Page 11: ...11 3 MANUAL DEFIBRILLATION PROBLEMS 69 11 4 AUTOMATED DEFIBRILLATION PROBLEMS 70 A 1 SYMBOLS 71 A 2 SCREEN MESSAGES 75 A 3 SPECIFICATIONS AND CHARACTERISTICS 77 A 4 DEFIBRILLATION WAVE 82 A 5 RHYTHM...

Page 12: ...DIH 0300 B USER GUIDE REANIBEX 300 iv TABLE OF CONTENTS...

Page 13: ...on 21 Figure 19 Apply electrodes display in Automated Defibrillator mode 24 Figure 20 CPR time display in Automated Defibrillator mode 25 Figure 21 Energy charge display in Automated Defibrillator mod...

Page 14: ...DIH 0300 B USER GUIDE REANIBEX 300 ii TABLE OF ILLUSTRATIONS Figure 36 Confirmation request during the Hardware Test 54 Figure 37 Defibrillation wave 82...

Page 15: ...f required It guides the user through the operating protocol x ECG Mode Available if the equipment has the patient cable connected to the equipment and always from Manual mode with electrodes no conne...

Page 16: ...GER PC application In addition to the patient related operating modes described above the REANIBEX 300 has a special switch on function that accesses the Configuration mode This mode is used to config...

Page 17: ...ding sections in this guide that explain these functions WARNING The REANIBEX 300 must be used on a single patient at a time 1 3 SAFETY CONSIDERATIONS HAZARD EXPLOSION HAZARD Possible explosion hazard...

Page 18: ...ROUS ELECTRIC SHOCK HAZARD The defibrillator can deliver up to 360 Joules of energy during shock delivery When the shock is being discharged to the patient do not touch the patient or the defibrillati...

Page 19: ...ent must be verified before using the REANIBEX 300 Avoid using the REANIBEX 300 placed next to or on other equipment If the equipment must be used next to or on other equipment make sure that the equi...

Page 20: ...omponents are properly connected Components or accessories that are not properly connected can cause fire or electrical shock PRECAUTION The REANIBEX 300 is intended for use in the presence of high fr...

Page 21: ...Do not use the batteries in environments with high humidity Make sure that the batteries do not get wet Do not crush bang dent or deform the batteries WARNING In AED mode place the disposable multifun...

Page 22: ...2 1 BASIC ORIENTATION This section provides basic guidelines regarding the REANIBEX 300 equipment its controls indicators and connectors 2 1 1 FRONT VIEW The following illustration shows the front vie...

Page 23: ...ding on the type of patient configured in the equipment the corresponding LED will light up under the adult paediatric icon ELECTRODE LOCATION INDICATOR When the electrodes are not connected to the eq...

Page 24: ...RY HOUSING This is where the battery is connected 2 1 3 SIDE VIEWS Figures 3 and 4 show the side views of the REANIBEX 300 The ECG connector can be seen on the left side for ECG mode A 3 lead patient...

Page 25: ...he display screen Several clearly differentiated areas are shown x BIOLOGICAL PARAMETER The biological parameter or vital sign of the patient is found at the top right of the display screen The parame...

Page 26: ...hen a VT VF alarm is active and the Channel 1 signal is being analysed o Internal memory status icon There are three different statuses to indicate the status of the internal memory Internal Memory OK...

Page 27: ...gned to each of these programmable buttons depends on the operating mode The operating mode on startup can be chosen in configuration mode between manual or DEA To change modes also use the softkeys T...

Page 28: ...cated under the display varies according to the operating mode in use x Manual Defibrillator Mode When the MENU button is pushed in this mode the options shown in the programmable buttons can be used...

Page 29: ...is switched on in the various operating modes The equipment is performing a test or requests user confirmation to check proper operation of the status indicator 2 6 BATTERIES The REANIBEX 300 can onl...

Page 30: ...attery is 5 years ATTENTION Only use batteries supplied by OSATU S Coop or its authorised distributors Using another type of battery may mean that the device does not operate correctly WARNING Follow...

Page 31: ...ent automatically detects the cable that is connected so the various leads can be viewed The reference of the patient cable approved by the manufacturer is listed in section A 7 ACCESORIES Figure 12 3...

Page 32: ...storage conditions Also check the expiry date of these electrodes ATTENTION Carefully follow the instructions indicated on the labels of the defibrillation and the monitoring electrodes Both the defi...

Page 33: ...ans of disposable multifunction electrodes for both adult and paediatric patients The equipment automatically detects the connection of the cable to the equipment and the type of patient depending on...

Page 34: ...d Figure 15 Battery installation To remove the battery press the dark grey lock inwards and pull firmly until the battery comes out See instructions in figure 15 Figure 16 Battery removal 3 4 CONNECTI...

Page 35: ...ch the equipment off and align the USB memory with the corresponding USB connector 2 Press until the USB memory is perfectly connected to the equipment Figure 17 USB memory connection WARNING Insert a...

Page 36: ...is performed automatically when the equipment detects a shockable rhythm If ventricular tachycardia is detected the shock is automatically synchronised with the signal The Automated Defibrillator mode...

Page 37: ...E ECG Do not perform the analysis inside moving vehicles The interferences caused by the movement of the vehicle can generate incorrect diagnoses Detection of movement can also delay the analysis WARN...

Page 38: ...onfiguration If it switches on in AED mode or the equipment is in another mode and the user wants to enter Manual mode press the mode change button and select AED mode When the REANIBEX 300 is switche...

Page 39: ...CPR has been set to OFF in the configuration options the pause for resuscitation is suspended In other words neither the progress bar nor the counter is displayed and the following message appears PRE...

Page 40: ...quipment the equipment will display the message SHOCK NOT DELIVERED and the value in the shock indicator at the top of the display will not increase Depending on the configuration of the equipment num...

Page 41: ...orised by a doctor or medical director and with the following aptitudes and training x Training in advanced resuscitation equivalent to that recommended by the AHA or the ERC x Recognition and treatme...

Page 42: ...bandages etc These contacts can cause electrical arcs and burn the patient s skin deviating a large amount of the defibrillation energy WARNING HAZARD OF BURNING THE PATIENT S SKIN During shock delive...

Page 43: ...following sections describe how to prepare the skin the various therapy electrodes available and how to place them The first step for Manual Defibrillation is to connect the appropriate defibrillatio...

Page 44: ...n Remove any medication patches or ointments from the patient s skin x Do no use pure alcohol or ether to clean the patient s skin since these increase skin resistance x Dry the patient s skin thoroug...

Page 45: ...configuration mode It will not be possible to modify them in manual mode during therapy 2 Charging the energy To charge the energy press the programmable button While the defibrillator is charging th...

Page 46: ...ergy has not been delivered or that the defibrillator is not working properly Defibrillation success is closely associated with the time that elapses between the appearance of a shockable heart rhythm...

Page 47: ...that the user has connected the electrodes the equipment will go to Manual mode automatically defibrillation is prioritized to display the ELECTRODES lead to select a signal analysis to control the c...

Page 48: ...charge capacity is disabled 6 2 WARNINGS AND PRECAUTIONS WARNING Possible misinterpretation of the ECG data The frequency response on the monitor display only identifies the basic ECG rhythm but does...

Page 49: ...nce x Dry the patient s skin thoroughly with a towel or gauze to eliminate skin oil and cells and improve electrode pad adherence Connect the monitoring electrodes to the patient cable before placing...

Page 50: ...lowing figure This figure shows how to place all the monitoring electrode pads depending on the patient cable available with the equipment Figure 23 Placing the monitoring electrode pads Normal placem...

Page 51: ...CG MODE 3 Verify that the lead II of the patient cable is shown in the display 4 Confirm that after a while the equipment shows the value of the patient s heart rate Figure 24 Heart Rate monitoring va...

Page 52: ...lse and is not breathing spontaneously as well as carry out cardiopulmonary resuscitation in addition to knowing the applicable medical protocols and procedures The unit can be used with any type of A...

Page 53: ...ct the default switch on scenario This can be modify during the use of the equipment in auto training mode 1 2 3 4 5 6 7 8 Scenario 7 configuration This establishes the result for each of the ten anal...

Page 54: ...ble Rythm Defibrilable Rythm Non Defibrilable Rythm 5 Defibrilable Rythm Electrodes problem simulation during 20 seconds Defibrilable Rythm Defibrilable Rythm Non Defibrilable Rythm 6 Defibrilable Ryt...

Page 55: ...the configuration of the equipment the various menus are protected by passwords the following symbol appears next to the menu option To modify these parameters a password must be entered Thus only aut...

Page 56: ...meter Once the desired parameters have been modified the changes are implemented by exiting the various menu options until the main Configuration screen appears A screen will appear requesting confirm...

Page 57: ...n ANALYSIS located under the screen again to start another analysis cycle CPR messages This is used to establish the level of detail provided by the voice prompt emitted when CPR 1 time is going to be...

Page 58: ...5 J 75 J and 90 J Paediatric shock energy 3 The third level of the energy protocol 40 J 45 J 50 J 65 J 75 J and 90 J Paediatric compression respiration ratio This establishes the ratio between compres...

Page 59: ...olume From level 1 to level 8 level 4 Keypad sound This establishes the predetermined volume emitted when a button is pressed From level 0 to level 8 level 4 NOTE The 0 setting indicates that no sound...

Page 60: ...described below 8 4 1 EQUIPMENT IDENTIFIER The EQUIPMENT IDENTIFIER consists of 16 characters that identify the equipment being used The default value is the serial number of the equipment but it can...

Page 61: ...operation of the equipment Changes to the default configuration must be performed by authorised personnel Take the following steps to reuse the configuration changes entered initially 1 Switch on the...

Page 62: ...ct and open the CONFIGURATION PASSWORD option Figure 31 Changing the CONFIGURATION mode access password 5 Use the programmable buttons to enter the new Configuration mode access password 6 After chang...

Page 63: ...mode on a patient o Last Shock The last date on which a defibrillation shock was delivered o Last HW Test The last date on which a Hardware Test was performed by the user in the Configuration mode Se...

Page 64: ...st episodes to a maximum of 10 To view this information 1 Switch on the REANIBEX 300 in Configuration mode 2 Use the programmable buttons to access the EQUIPMENT INFORMATION option 3 Select and open t...

Page 65: ...MEMORY When the user accesses the USB menu in Configuration mode the equipment checks that there is a USB memory connected to the appropriate port If so it displays the USB options so the user can upl...

Page 66: ...r of the data x Upload settings from the equipment to the PC x Upload episodes from the equipment to the PC x Upload the last tests from the equipment to the PC x Upload the last errors from the equip...

Page 67: ...by the REANIBEX 300 in the status indicator is viewed correctly For the audio emission test the user has to confirm that the voice prompt that is emitted can be heard correctly The results of the test...

Page 68: ...TEST This option is used to check that all the buttons and indicators on the user interface work correctly When this option is accessed a screen is displayed representing the user interface of the REA...

Page 69: ...The battery is not installed in the equipment If an Auto Test cannot be performed for the reasons indicated above it will be attempted again if x It is in the time period established for Auto Tests x...

Page 70: ...the type of test the result and date the test was performed The REANIBEX 300 also indicates any incidents affecting the internal memory in charge of saving the episodes since the memory may be affect...

Page 71: ...equipment but not to a patient CHECK THE ELECTRODES The electrodes are connected to the equipment but their terminals are short circuited CHARGE energy in JOULES Charges a level of energy SHOCK energ...

Page 72: ...The equipment will go out of service When this type of failure is detected the status indicator will present the icon When the equipment is switched on the message ERROR XXX with an error code will a...

Page 73: ...tact the Authorised Technical Service Sufficient defibrillation electrodes present None Defibrillation electrodes expired or open Replace the defibrillation electrodes Battery damaged or leaking Repla...

Page 74: ...um compounds x Isopropyl or ethyl alcohol dissolved to 70 in water PRECAUTION The ECG cable must not be cleaned with ultrasounds submerged or sterilised in an autoclave or with stream Do not clean the...

Page 75: ...roken Follow the local regional or national regulations in your country for recycling x For rechargeable Li ion batteries Store the battery at under 30 C and never expose the battery to temperatures o...

Page 76: ...l life of the battery is 2 years or 500 charge discharge cycles To optimise battery performance discharge the battery completely or almost completely whenever possible While it is in operation and whe...

Page 77: ...al procedures applicable to each country The disposable defibrillation and monitoring electrodes must be recycled according to the local regional or national clinical recycling procedures applicable i...

Page 78: ...DIH 0300 B USER GUIDE REANIBEX 300 64 10 MAINTENANCE 10 9 ACCESSORIES The list of all the accessories that can be used with the REANIBEX 300 is included in Section A 7 ACCESSORIES...

Page 79: ...UTION The REANIBEX does not switch on No power supply Insert a fully charged battery An internal fuse has blown Contact the Authorised Technical Service The REANIBEX works but the screen does not swit...

Page 80: ...ed if not contact the Authorised Technical Service The operating mode of the equipment does not correspond to the button that was pressed Make sure that the button pressed corresponds to the selected...

Page 81: ...les are not tense and do not pull on the electrodes Clean and dry the patient s skin and place new electrode pads making sure they adhere properly Breathing interference If possible place the electrod...

Page 82: ...are off connect them again The contact between the cable leads and the patient is not adequate Make sure that the monitoring electrode pads are placed correctly If necessary prepare the patient s ski...

Page 83: ...ction electrodes properly to the patient The screen displays the message PRESS CHARGE The shock button on the user interface has been pressed without previously charging the energy Before delivering t...

Page 84: ...r completion of energy charge The energy has been discharged internally The next time the visible and audible PRESS TO SHOCK message appears after detecting a shockable rhythm and charging the energy...

Page 85: ...2012 12 33 Date and time set up in the equipment 01 27 00 Time elapsed since the equipment was switched on Heart rate pulse rate indicator The Heart Rate HR setting cannot be detected Go to next page...

Page 86: ...ttery empty Equipment ready for use Low battery charge under 20 Equipment missing battery Error detected in the equipment CF Class Equipment Component Unprotected against defibrillation CF Class Equip...

Page 87: ...h applicable European Directives ACCESSORIES Follow the instructions for use Rechargeable battery Disposable battery Symbol of conformity with applicable European Directives Temperature range recommen...

Page 88: ...tery serial number Battery expiry date Battery manufacturing date PACKAGING Fragile Breakable Handle with care Protect from water Pressure range altitude recommended for storage from 52 2 KPa to 76 0...

Page 89: ...errupted during the energy charging process DISARMING The equipment is discharging the energy internally PRESS TO SHOCK The equipment is ready to deliver the shock and waiting for the user to press th...

Page 90: ...DIH 0300 B USER GUIDE REANIBEX 300 76 A 2 SCREEN MESSAGES MESSAGE DESCRIPTION ERROR XXX An error has been detected in equipment operation...

Page 91: ...tion of 1 7 mV Audible alarms The alarm tones are described below Equipment prepared for shock sound Lead off sound Sound to draw attention to the display AED analysis Audible alarm pressure range Tec...

Page 92: ...ion Charging tone end of charge tone and shock button on the user interface flashing for disposable multifunction electrodes Shock Control Front panel button with 4 LEDs Charging time Li ion Less than...

Page 93: ...ty Complies with AHA NSR specificity Complies with AHA Specificity for other signals Complies with AHA Maximum time from start of rhythm analysis to prepared for shock status Li ion Less than 20 secon...

Page 94: ...onnector location indicator Auto Tests On Start up During operation Manuals on user request Automatic daily monthly weekly POWER SUPPLY Rechargeable battery Type Li ion 14 4 VDC rechargeable Capacity...

Page 95: ...r resistance IP 5 Vibration EN1789 Shock EN1789 PHYSICAL CHARACTERISTICS Weight Equipment 2 4 Kg Equipment with disposable electrodes ECG cable 3 lead and battery 2 9 Kg LiSO2 battery 500 g Li ion bat...

Page 96: ...ces that vary between 25 and 300 If impedance is less than 25 the equipment interprets that there is a short circuit in the defibrillation electrodes In the event of impedances greater than 300 the eq...

Page 97: ...ED Defibrillation using biphasic waveforms is currently proving to be more effective than conventional monophasic waveforms because it requires less energy In addition this waveform causes less displa...

Page 98: ...and verify the Rhythm Detection System Each of these databases contain samples of different types of rhythms in both adult and paediatric patients classified by expert doctors The types of rhythms tha...

Page 99: ...be used in the electromagnetic environments described in the following tables The user of the equipment must ensure that it is used in these environments The following tables include the minimum reco...

Page 100: ...Hz d 2 3 P de 800MHz a 2 5GHz P is the maximum output power of the transmitter in Watts W according to the manufacturer of the transmitter and d is the recommended intervening distance in meters m b A...

Page 101: ...KHz to 80 MHz outside ISM bands d 1 2 P 150 KHz to 80 MHz within ISM bands d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 12 0 23 0 1 0 38 0 38 0 38 0 73 1 1 2 1 2 1 2...

Page 102: ...osable multifunction electrode pads for children KSA 0501 A ECG MONITORING 3 lead ECG patient cable KPA 0400 A Disposable monitoring electrode pads for adults 50 electrodes bag TKL 102 A Disposable mo...

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