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Содержание REANIBEX 300

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

Страница 2: ......

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

Страница 4: ...Blank page...

Страница 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...

Страница 6: ...Blank page...

Страница 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...

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Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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