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Manufacturer

Instramed Indústria Médico Hospitalar Ltda.

Industrial unit:
Beco José Paris, 339 – Pavilhões 18 e 19

Postal code: 91140-310

Porto Alegre – RS, Brazil

Phone/Fax number: +55 51- 3073 8200

Email: [email protected]

www.instramed.com.br

European representative

Obelis S.A.
Bd. Général Wahis 53, 1030, Brussels - Belgium

Tel. : + 32.2.732.59.54

Fax : + 32.2.732.60.03

E-mail : [email protected]

ATTENTION: Instramed assumes no responsibility for any damage caused to

individuals or property brought by failure to use this product in accordance

with the information, recommendations and warnings presented in the user

manual, alterations made in the device, attempts of repair not provided by

authorized technical assistance centers, operation by unqualified personnel,

use of defective device or use of accessories and parts not supplied by the

manufacturer.
For information about warranty or technical assistance, please contact

Instramed’s technical support.

Médico Hospitalar Ltda. The internal software of this product is Instramed’s intellectual property, being protected under

international copyright laws. It is provided exclusively to be used with this present device, identified by the serial number, and

may not be, in whole or in part, evaluated, recompiled or altered in any way.

I.on/I.on PRO User Manual R1.10 English 2020-08-09

ANVISA

10242950016

2460

Содержание I.ON

Страница 1: ...User manual AUTOMATED EXTERNAL DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION ...

Страница 2: ...the device attempts of repair not provided by authorized technical assistance centers operation by unqualified personnel use of defective device or use of accessories and parts not supplied by the manufacturer For information about warranty or technical assistance please contact Instramed s technical support Copyright 2019 Instramed The I on I on PRO Instramed and its respective logos are trademar...

Страница 3: ...battery charge may be consumed Therefore whenever the device is not connected to the mains for 8 months it is recommended to fully charge the battery only for rechargeable batteries If this procedure is not performed there is a risk of draining the battery and consequently being unable to use the I on I on PRO in its portable configuration not connected to the electric current Rechargeable batteri...

Страница 4: ...ual and SOFTDEA management PC software Optional items A power supply for charging internal battery A cable for connecting the power supply to the electric current A pair of disposable child size adhesive pads 3 Lead ECG cable Accessory for chest compression CPR Maestro Replacement parts You can ask Instramed for replacements of the following items consult Instramed for prices Shipping costs may be...

Страница 5: ...andards 15 Device care 15 Cleaning 16 Connection to other equipment 17 Disposing of the device 17 Precautions 17 Classification and symbols 18 The equipment 20 Front Panel Models I on and I on PRO with LCD screen 20 1 Touch screen 21 Front panel Model I on without LCD screen 24 1 Indicative LEDs of the care stage 25 2 Operational status indicator 26 3 Speaker 27 4 Start button 28 5 Microphone opti...

Страница 6: ...arging the battery 32 Operating in AED mode 33 Step 1 34 Step 2 35 Step 3 36 Step 4 37 Step 5 37 Simplified diagram of procedure in adults 38 Operating in manual mode 40 Step 1 41 Step 2 42 Step 3 43 Step 4 44 Step 5 44 Simplified diagram of procedure in adults 45 Applying CPR 47 Use in children 49 Using the I on I on PRO on children under 8 years old 49 ECG monitoring 50 Using ECG 51 ...

Страница 7: ...ling the SoftDEA using the website 58 Connecting the I on I on PRO to a PC 58 Operating SoftDEA 59 Initial screen 59 1 Close button 59 2 Minimize button 59 Adjusts screen 60 1 Options bar 60 2 Back button 60 3 Clock button 60 4 Volume level 61 Languages screen 62 1 On the application 62 2 On the equipment 62 Recordings screen 63 1 Download 63 2 Open 63 3 List of audios 63 4 Player 64 ...

Страница 8: ... Precautions restrictions and warnings 68 Electromagnetic compatibility 68 Attention 68 Warnings 68 Electromagnetic emissions 69 Electromagnetic immunity General 70 Electromagnetic immunity Equipment with life support functions 71 ECG analysis algorithm 74 Types of arrhythmia analyzed 76 Specifications 77 General specifications 77 Environmental specifications 79 Defibrillator 79 CPR Maestro 81 Pre...

Страница 9: ...ion and detector table 82 ECG 85 ECG electrodes adult and child 86 Alarm system 87 Information signals 88 Care and maintenance 90 Preventive Maintenance 90 Corrective Maintenance 90 Accessories 91 Included 91 Optional 92 Warranty certificate 93 ...

Страница 10: ...ation area the user selects the operation mode and charge while visualizing the ECG curve The interface is simple and self explanatory Characteristics Semi automated Artificial Intelligence accurate diagnosis of the patient s conditions indicating shock delivery or not Safety precautions prevents accidental use in cases in which shock treatment is not advisable or in healthy people Operation with ...

Страница 11: ...he most important factor in survival is how fast treatment is delivered Ideally treatment should not be delayed for more than four minutes from the beginning of the defibrillation Principle Defibrillation is the electrical shock therapy responsible for reversing cardiac arrest caused by ventricular fibrillation or ventricular tachycardia without a pulse The I on I on PRO uses the BIPHASIC SHOCK te...

Страница 12: ... Once the removal of the patient is started the defibrillation must be interrupted Qualified users Shall be considered qualified users those who have had training in a recognized institution in the use of automated defibrillators and CPR techniques Cardiopulmonary Resuscitation About the manual The function of this guide is to explain how the I on I on PRO Automated Defibrillator series works aler...

Страница 13: ...ith the patient and keep him still during rhythm analysis WARNING I on I on PRO can be used by patients over 01 one year old regardless of their weight WARNING the patient must be placed on non conductive surfaces Do not use wet or metallic surfaces and if necessary dry the chest before applying the shock WARNING do not touch the patient the equipment the accessories nor any metallic or conductive...

Страница 14: ...to the mains via its AC DC external source The same way I on I on PRO should not be connected to the mains via its AC DC external source while the pads are positioned on the patient Under these conditions the leakage current limits defined in EN 60601 1 and EN 60601 2 4 for this class of equipment may be exceeded ATTENTION I on I on PRO should not be connected to the AC DC external source when in ...

Страница 15: ...ential performance Collateral standard Electromagnetic compatibility Requirements and test IEC 60601 1 6 Medical Electrical Equipment Part 1 6 General requirements for basic safety Collateral Standard Usability IEC 60601 1 8 Medical electrical equipment Part 1 8 General requirements for basic safety and essential performance Collateral standards General requirements testes and guidance for alarm s...

Страница 16: ...e procedure in room temperature CLEANING THE ACCESSORIES For the ECG cable Clean the cable the connection box and the surfaces of contact with the patient with a soft cloth moistened with water or neutral disinfection solution dry the cable to use again The cleaning must be periodic Keep the plugs dry For the CPR MAESTRO Moisten a cloth with clean water and neutral detergent and clean the device u...

Страница 17: ...available on the website www instramed com br or by e mail qualidade instramed com br Avoid contamination of the environment humans or other equipment by make sure to properly decontaminate the equipment before disposing of it Refer to local regulations for the proper disposal of trash in your area For countries that follow European Guidelines refer to 2002 96 CE Precautions Danger of EXPLOSION do...

Страница 18: ...um stacking of 4 units Keep away from rain Storage temperature limits Operation temperature limits Minimum and maximum atmospheric pressure Minimum and maximum relative humidity Recyclable paper Remains of electrical and electronic equipment Dispose of separately from other disposables 2460 Mark of conformity according to the European Community 2460 stands for the number of the Notified Body Inter...

Страница 19: ...er supply Does not contain natural rubber LATEX Do not reuse Non sterile Do not use if the packaging is damaged Keep away from sunlight Adhesive pads operation temperature limits Check instructions for use LOT Lot code REF Catalog number Date after which the product cannot be used The norms EN 60601 1 and ISO 15223 are used as reference to the symbols ...

Страница 20: ...5 1 1 Touch screen presents operational information and allows for manual interaction with the device 2 Operational status indicator 3 Speaker 4 Start button 5 Microphone optional On the next pages you will find the detailed description of each component of the front panel 20 ...

Страница 21: ...hen connected to the patient 1 Heart beats per minute 2 CPR interval counter counts the interval between discharge delivery helping in the CPR 3 Battery status 4 Orientation message 5 ECG curve 6 Icon indicating the defibrillation stage 00 19 80 Shocks 0 00 00 20 Derivation D2 0 25 mV 1 2 3 4 6 5 only I on with LCD screen ...

Страница 22: ...19 80 6 1 2 5 3 4 7 8 9 1 Heart beats per minute 2 Shocks counter shows the total number of defibrillations successfully executed 3 General timer shows the total time of the equipment being on 4 CPR interval counter counts the interval between discharge delivery helping in the CPR Cardiopulmonary resuscitation massage 5 Battery status 6 Orientation message 7 Manual mode button 8 ECG curve 9 Icon i...

Страница 23: ... 2 5 3 4 7 8 9 10 11 1 Heart beats per minute 2 Shocks counter shows the total number of defibrillations successfully executed 3 General timer shows the total time of the equipment being on 4 CPR interval counter in manual mode this indicator shows the continuous counting since the beginning of the operation 5 Battery status 6 Charge selector allows the user to select the desired energy charge 7 S...

Страница 24: ...del I on without LCD screen 2 3 4 5 1 1 Indicative LEDs of the care stage 2 Operational status indicator 3 Speaker 4 Start button 5 Microphone optional On the next pages you will find the detailed description of each component of the front panel ...

Страница 25: ...User manual The equipment 25 1 Indicative LEDs of the care stage Visual accompaniment LEDs of the care stage light up in sequence ...

Страница 26: ...rechargeable battery change the battery immediately In case of rechargeable battery charge the battery immediately After changing or recharging the battery turn on the equipment to perform the auto test If the indicator remains red contact Instramed Technical Support or an authorized representative It indicates that the device DOES NOT HAVE ENOUGH CHARGE It indicates that the device DOES NOT HAVE ...

Страница 27: ...vice will not turn on in case of low battery or presenting general failure In this case only the audible beep warning will be issued 3 Speaker The I on I on PRO is a highly complex equipment which from the moment of activation assesses the steps of the operation and the general state of the patient Based on this analysis the device guides the user through verbal commands which may be warnings inst...

Страница 28: ...witch the I on I on PRO off Fifteen seconds after the removal of pads from the patient or disconnection of pads from the equipment the device switches itself off saving battery charge In this moment the following message will be heard The device is being turned off Press the button in order to turn the machine back on Even so there are two ways to manually switch off press the start button for thr...

Страница 29: ...User manual The equipment 29 Side connectors 3 2 1 1 ECG connector only in the models with LCD screen 2 CPR Maestro connector 3 Disposable pads connector ...

Страница 30: ... of disposable pads to the equipment ATTENTION whenever the pads set is replaced remember to keep the new pair already connected ATTENTION disposable pads have defined expiration date Check the enclosure for limit date for use and if it is not used within this time replace them with a new pair ATTENTION only use original pads supplied by Instramed Failure to do so may result in malfunction Only mo...

Страница 31: ...B connector 1 Battery compartment It holds the internal batteries of the equipment ATTENTION in case of battery replacement use original replacements from Instramed supplied by its authorized distributors 2 USB Connector Used for connecting the equipment to a PC see chapter 10 ...

Страница 32: ...the charger using the input indicated below 1 1 Battery charger connector VISUAL INDICATOR Visual indicators of the charging process may be found in the charger 1 2 1 BATTERY LED ON indicates that the internal battery is being charged OFF indicates complete charge 2 MAINS LED ON indicates that the equipment is connected to the mains supply ...

Страница 33: ...ly memorize the detailed guide on the next pages before operating the equipment 3 2 4 1 5 6 Press button to start cycle Press button to deliver shock Equipment analyzes patient s condition Shock delivered start CPR Cardiopulmonary Resuscitation Place pads on patient Analysis is concluded shock is recommended The energy delivered is pre adjusted at the factory according to the values below The oper...

Страница 34: ... connector to the plug on the right side of the equipment After disposing of used pads always leave a replacement pair already connected to the equipment avoiding having to replace them at the moment of the emergency ATTENTION this device has electronic safeguards and will not operate in inadvisable situations Check patient s condition Only use the equipment if the patient is not breathing ...

Страница 35: ... whole thoracic cage ATTENTION the area in contact with the pads must be dry ATTENTION the presence of too much hair in the contact area may affect scanning In this case shave hair ATTENTION the pads must be applied directly over the skin DO NOT place pads over clothes ATTENTION the pads are disposable and for single use cannot be reused under any circumstances ATTENTION after opening the wrapping...

Страница 36: ...nd Visual indications of each step will also be shown on the LCD screen or indicated by means of indicative LEDs according to the model ATTENTION the patient must be on a steady surface Any movement du ring the process of clinical analysis will result in mistaken scans ATTENTION the pads are disposable and can be used in only one patient at a time Remember to always keep extra ones with the equipm...

Страница 37: ... in contact with him her during shock delivery under risk of suffering a powerful electric discharge ATTENTION disconnect other equipment which do not have defibrillation protection before defibrillating the patient If clinical scans show that defibrillation is not recommended the I on I on PRO will announce TREATMENT NOT RECOMMENDED Check that the patient did not move during the analysis period I...

Страница 38: ... Recovers pulse breathing Restarts the cycle Restarts the cycle CPR for 2 minutes No pulse no breathing recovery Shock recommended Shock delivered Check patient s condition Place victim on a dry flat and steady area The I on I on PRO analyzes patient s condition Shock NOT recommended Move away from the patient Activate AED CPR for 2 minutes Wait for emergency team Wait for emergency team Place pad...

Страница 39: ... Call emergency service Check patient s condition Not breathing Place victim in a dry flat steady area Place pads Activate the I on I on PRO The I on I on PRO analyzes patient s condition Shock NOT recommended CPR for 2 minutes It doesn t recover breath and or movements Shock recommended Move away from the patient Activate AED Shock applied CPR for 2 minutes Wait for emergency team Wait for emerge...

Страница 40: ...de change the I on I on PRO ceases to emit sound and visual orientation in addition to the automatic safeguards against shocks Press button to start cycle Press button to deliver shock Place pads on patient Shock delivered Start CPR Cardiopulmonary Resuscitation Activate manual mode Select charge and charge energy ATTENTION the use of the manual mode is the user s entire responsibility The use by ...

Страница 41: ...nector to the plug on the right side of the equipment After disposing of used pads always leave a replacement pair already connected to the equipment avoiding having to replace them at the moment of the emergency ATTENTION this device has electronic safeguards and will not operate in inadvisable situations Check patient s condition Only use the equipment if the patient is not breathing only I on P...

Страница 42: ...e thoracic cage ATTENTION the area in contact with the pads must be dry ATTENTION the presence of too much hair in the contact area may affect scanning In this case shave hair ATTENTION the pads must be applied directly over the skin DO NOT place pads over clothes ATTENTION the pads are disposable and for single use cannot be reused under any circumstances ATTENTION after opening the wrapping the ...

Страница 43: ... on the device s screen Confirm this choice on the following screen The I on I on PRO will switch to manual mode Follow the instructions Place pads on the patient Do you confirm switch to Manual Mode Yes No If the user does not confirm the switch in 5 seconds the device will return to automatic mode only I on PRO ...

Страница 44: ...ivered ATTENTION the user must not touch the patient or conductive surfaces in contact with him her during the shock delivery under risk of suffering a powerful electric discharge ATTENTION disconnect other equipment which do not have defibrillation protection before defibrillating the patient Step 5 After the shock start the CPR procedure see more in section 6 only I on PRO ...

Страница 45: ...vers pulse breathing Restarts the cycle Restarts the cycle CPR for 2 minutes No pulse no breathing recovery Shock recommended Shock delivered Check patient s condition Place victim on a dry flat and steady area The I on I on PRO analyzes patient s condition Shock NOT recommended Move away from the patient Activate AED CPR for 2 minutes Wait for emergency team Wait for emergency team Place pads Act...

Страница 46: ... emergency service Check patient s condition Not breathing Place victim in a dry flat steady area Place pads Activate the I on I on PRO The I on I on PRO analyzes patient s condition Shock NOT recommended CPR for 2 minutes It doesn t recover breath and or movements Shock recommended Move away from the patient Activate AED Shock applied CPR for 2 minutes Wait for emergency team Wait for emergency t...

Страница 47: ...t above the stomach 3 Keep two fingers right below this point 4 Place the palm of your other hand above the two fingers that indicate the base of the Sternum bone This is the correct spot for the massage 5 Put one palm on top of the other keeping your fingers curled up without touching the thorax In small children however use only your fingers Apply force according to the victim s size 6 Keep your...

Страница 48: ...terval to perform mouth to mouth breathing check if the patient s pulse is back The massage and ventilation cycle must be done for two minutes If the patient s pulse does not return restart shock procedure with the I on I on PRO After the third complete CPR and shock cycle chances of the patient s resuscitation are very slim ATTENTION the CPR techniques shown in this manual are only referential an...

Страница 49: ...ards However on patients from one year of age to eight years of age or patients who weigh less than 25 Kg some precautions must be taken Use child pads If the pads cannot be placed within the minimal distance of 4 centimeters between them place one of them on the child s chest and another on his back Shorter than 4 cm Chest Back Larger than 4 cm ...

Страница 50: ... The I on I on PRO monitors only the DII ECG derivation The ECG sweep speed is fixed at 25 mm s The displayed ECG amplitude scale is automatic and shown in mV according to images below I on PRO 00 19 80 Shocks 0 00 00 20 0 25 mV I on with LCD screen 00 19 80 Shocks 0 00 00 20 Derivation D2 0 25 mV only models with LCD screen ...

Страница 51: ...col Only ECG cable connected the equipment silently monitors the patient s ECG always in DII derivation and alarms when it detects a cardiac arrest situation In this situation and in case of shock indicated the adhesive pads must be connected Using ECG Connect the ECG patient cable to the equipment using the input indicated below located on the side of the equipment Electrode technical description...

Страница 52: ...e displayed on CPR Maestro and I on I on PRO screens and through sound recommendations NOTE because it is an accessory it cannot be used by itself Only connected to I on I on PRO The on screen and audible messages will only be displayed after the guidance Perform CPR for 2 minutes To turn off the CPR Maestro simply press the ON OFF button for 3 seconds Using the CPR Maestro 1 Connect the CPR Maest...

Страница 53: ...ation of the compressions Initialization with the device out of the recommended position may cause incorrect compression evaluations CAUTION for long lasting CPR in naked chest place a gauze between the skin and the CPR MAESTRO to avoid risk of skin abrasion ATTENTION do not use CPR MAESTRO on patients under 8 years old or under 25 Kg 4 A message on the CPR MAESTRO will be displayed to confirm tha...

Страница 54: ...hest expansion the rescuer is not allowing the patient s chest to return to total relief position Compress softer the rescuer exceeded the limit of chest compression which is of 60mm Compress faster the rescuer is performing the compressions at a frequency below the ideal limit which is of 100 to 120 compressions per minute Compress slower the rescuer is performing the compressions at a frequency ...

Страница 55: ...wider in the indicated direction 3 Depth indicative bar indicates the current depth of the compression 4 Maximum depth indicator when filled with the white indicates that the compression reached the ideal depth When filled with the red indicates too hard compression 5 Frequency indicative bar indicated the frequency of the compressions When aligned with the red rectangles indicates need of frequen...

Страница 56: ...User manual CPR Maestro 56 When the rescuer stops the compressions a chronometer is automatically displayed on the graphic area ...

Страница 57: ...eck and update firmware version of the equipment only for authorized technicians Requirements Connecting the I on I on PRO to a PC requires installation of the SoftDEA application in the computer to which a connection will be made This software is in the CD which comes with the equipment To install SoftDEA observe the following requirements Windows 7 or Windows 10 operating system CPU of 500 MHz o...

Страница 58: ...to a PC Connect the equipment only after installing SoftDEA After the installation connect the equipment using the USB cable provided To access the USB connector the user must remove the battery and plug the USB connector into the equipment and the PC The equipment will use USB power to connect Start the SoftDEA application On the language selection screen choose among Spanish English or Portugues...

Страница 59: ...Operating SoftDEA 11 59 Initial screen Select I on I on PRO 2 1 1 Close button Press this button to close the application 2 Minimize button Press this button to minimize the application ...

Страница 60: ...he USB cable provided 4 3 1 2 update 1 Options bar Through the bar it is possible to access the software screens just click on the desired option 2 Back button Press this button to return to the initial screen in which it is possible to choose the desired device 3 Clock button Press the update button so that the clock is synchronized with the time of the PC connected to the I on I on PRO ...

Страница 61: ...ring the password to perform the operation will open ATTENTION level 1 is the lowest volume level 55 dB and may be inaudible in a noisy environment In compliance with the standards of alarms IEC 60601 1 8 the change of volume is performed by means of a secure password to avoid misuse The default SoftDEA password is 123456 but it can be changed by the user to have high security criteria ...

Страница 62: ...is feature alters the language of the voice warnings emitted through the speakers for the selected language 2 On the equipment Connect the I on I on PRO to the computer Click on the desired language option This feature alters the language of the voice warnings emitted through the speakers for the selected language ...

Страница 63: ...utton to open wav files previously stored on your computer One or more audio files can be opened at one time 3 List of audios After downloading the audio recorded by the microphone contained in the memory of the I on I on PRO in this area the list will be displayed The file names are equivalent to the date and time they were originally stored For example 19092019105951 is equivalent to day 19 mont...

Страница 64: ...of the audio being played Shocks screen 1 2 1 Define shock sequence Choose the energy value for the first second and third shocks Click the send button to send the values to the device Through this window it is possible to set the values of the three shocks of the device s auto sequence in AED mode 2 Previous sequence Allows to view the last shock sequence recorded on the device ...

Страница 65: ...s previously generated events A window will open allowing the user to choose the desired file storage location 2 Open Press this button to open a dea file previously stored on the computer 3 Print Click this button to print the events selected on the screen Use the Windows print dialog to choose your printer Printing is only done in landscape mode with one page per sheet ...

Страница 66: ...n event in the curve area click on it To select more than one event click one of the desired events then click the ctrl key hold it down and select other events In addition it is possible to select events in sequence by clicking the first event in the sequence then clicking the shift key holding it down and clicking the last event in the desired sequence To view how many events have been selected ...

Страница 67: ...zing heart rhythm ASYSTOLE Asystole detected PADS DISCONNECTED The pads were disconnected CHILD PADS Child pads were connected to the device ADULT PADS Adult pads were connected to the device TURNED ON The equipment was turned on CPR events COMPRESS HARDER It is necessary to compress the patient s chest harder COMPRESS SOFTER It is necessary to compress the patient s chest softer COMPRESS FASTER I...

Страница 68: ...ual Mobile and portable RF communications equipment such as a cellphone may affect the functioning of the I on I on PRO Maximum length of accessory cables in order to comply with the requirements of Electromagnetic Compatibility is 2 5 m All parts and accessories listed below follow the requirements for Electromagnetic compatibility Pair of disposable adhesive pads adult size Pair of disposable ad...

Страница 69: ...that they meet or exceed the minimum values specified WARNING the I on PRO is suitable for use in professional health care environments CAUTION do not use the equipment in the presence of MRI devices Measures must be taken to minimize interference from high frequency surgical equipment The actions to be taken to prevent adverse events to the patient and the operator due to electromagnetic disturba...

Страница 70: ... input output lines The quality of the power supply should be that of a typical commercial or hospital environment Surge EN 61000 4 5 1 KV differential mode phase phase 2 KV common mode phase ground 1 KV differential mode phase phase 2 KV common mode phase ground The quality of the power supply should be that of a typical commercial or hospital environment Voltage dips short interruptions and volt...

Страница 71: ... applied NOTE 2 these directives may not be applicable in all situations Electromagnetic transmission is affected by the absorption and reflection of structures objects and people a ISM bands industrial medical and scientific between 150 kHz and 80 MHz are 6 765 MHz to 6 795MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency...

Страница 72: ...11 38 3 8 7 3 100 35 120 12 23 For transmitters with a maximum output power not listed above the advisable separation distance d in meters m can be determined by using the equation applicable to the frequency of the transmitter where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer NOTE 1 at 80 MHz and 800 MHz the separation distance for the hig...

Страница 73: ...Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT Band LTE 1 3 4 25 UMTS Pulse modulationb 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 Band LTE 7 Pulse modulationb 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulationb 217 Hz 0 2 0 3 9 5500 5785 NOTE if necessary to reach the IMMUNITY TEST LEVEL the distance between the transmitting an...

Страница 74: ...eport Recording Methods the files were acquired via internet through the MIT BIH database and used via computer ECG Rhythm Sources MIT BIH on http ecg mit edu Rhythm Selection Criteria rhythms were chosen according to notes present in the MIT BIH database Criteria and Annotation Methods the rhythms were recognized and annotated in a separate file Later they were recognized and compared for sensiti...

Страница 75: ...ement units to correctly identify a shockable rhythm A false positive B is the equipment s ability in measurement units to wrongly recognize a shockable rhythm A false negative C is the equipment s ability in measurement units to wrongly recognize a no shockable rhythm A true positive D is the equipment s ability in measurement units to correctly recognize a no shockable rhythm Values measured wit...

Страница 76: ...extrasystoles Sinus rhythm with pacemaker Asystole Shockable Ventricular tachycardia with several QRS amplitudes and widenings Ventricular fibrillation with several amplitudes Rhythm classes Specifications Shock VF The I on I on PRO meetsEN 60601 2 4 requirements for sensitivity 90 Shock VT The I on I on PRO meets IEC 60601 2 4 requirements for sensitivity 75 No shockable rhythms The I on I on PRO...

Страница 77: ...s in 200 J or 15 hours of continuous monitoring and 5 years of lifespan in standby Note discharge tests performed on the I on I on PRO configuration with LCD Rechargeable internal battery Type Li Ion 14 4 VDC 4 0 A h Duration 18 hours in heart rate recognition mode fully charged battery or a minimum of 400 shocks in 200 J Time for battery full charge fully discharged 5 hours Battery power supply c...

Страница 78: ...between 120 J and 360 J Internal memory storage 100 events or 2 hours of ECG recording Ambient sound storage Up to 10 hours optional Protection rating IP56 Classification Class II internally energized equipment Electrical insulation CF type Operating mode Continuous operation Maximum time from rhythm analysis beginning to discharge readiness 20 seconds Maximum time from rhythm analysis beginning t...

Страница 79: ...0 to 50 o C Storage 20 to 50 o C Humidity Operational 10 to 95 RH without condensation Storage 10 to 95 RH without condensation Altitude Recommended to use in altitudes lower than 2000 meters Defibrillator Waveform Biphasic truncated exponential Wave shaped parameters adjusted according to the patient s impedance Shock application By means of multifunctional adhesive pads Commands Front panel butt...

Страница 80: ... beginning to discharge readiness non rechargeable battery and 200 J 30 seconds Maximum time from rhythm analysis beginning to discharge readiness non rechargeable battery and 360 J 35 seconds Maximum charging time Rechargeable battery 50 J 2 seconds 150 J 3 seconds 200 J 4 seconds 250 J 5 seconds 360 J 6 seconds Non rechargeable battery 1400 mAh 50 J 3 seconds 150 J 8 seconds 200 J 11 seconds Non...

Страница 81: ... energy Impedance Accuracy 25 50 75 100 125 150 175 50 49 0 52 0 53 0 52 5 51 5 48 0 45 5 15 150 143 0 151 5 155 0 153 0 148 0 141 0 137 0 15 200 191 5 201 5 205 5 206 0 203 5 192 0 177 0 15 360 344 0 363 0 370 5 370 0 363 0 345 0 322 0 15 Patient s impedance response table Patient s impedance Shock Short circuit Shock inhibited 25 Ohms Shock inhibited 25 Ohms and 300 Ohms Shock delivered with a w...

Страница 82: ...thms Shock indicated 329 23 Shock NOT RECOMMENDED 10 454 Sensitivity 97 05 Specificity 95 18 Tests carried out with the MIT BIH database Values on the Y axis refer to voltage volts and values on the X axis refer to time milliseconds 200 J of energy at 25 R impedance 200 J of energy at 50 R impedance ...

Страница 83: ...User manual Specifications 83 200 J of energy at 100 R impedance 200 J of energy at 75 R impedance 200 J of energy at 125 R impedance ...

Страница 84: ...User manual Specifications 84 200 J of energy at 175 R impedance 200 J of energy at 150 R impedance ...

Страница 85: ...3 V current 10 µA and impedance 360 kohms The circuit of disconnected derivations active noise detection suppression is 0 2 µA T wave maximum amplitude Meets the recommended minimum rejection value of the T wave amplitude of 1 2 mV Minimum amplitude of the ECG signal The minimum amplitude of the patient s ECG signal is 0 05 mV 50 µV Operation with ECG signals below this range may produce inaccurat...

Страница 86: ...for ventricular tachycardia ECG electrodes adult and child Composition Adhesive conductor with hydrogel and silver sensor Ag AgCl latex free biocompatible according to ISO 10993 1 Use instructions 1 Shave hairs clean the spot and dry with gauze 2 Before removing the protective film attach the ECG wire to the electrode 3 Remove the film from the electrode and put it in place by pressing firmly Prec...

Страница 87: ...he patient SOUND LEVEL Configurable between 65 and 85 dB A through PC software application SoftDEA ALARM SIGNAL GENERATION DELAY Lower than 5 seconds OPERATOR S POSITION The operator must be facing the front side of the device at a maximum distance of 50 cm Pausing and turning off the alarm signals Following the standard EN 60601 2 4 it is not possible to turn off or pause the alarm signals for th...

Страница 88: ...re of the current step of the AED procedure AED mode only Picture that indicates to operator which stage of the automatic procedure the equipment is performing at the moment Battery level indicator Only models with LCD screen Indicates the approximate device s battery level Energy selected manual mode only Only I on PRO Indicates the energy selected by the operator See section The equipment item O...

Страница 89: ...eart rhythm Perform CPR for two minutes Treatment recommended do not touch the patient Treatment is not recommended Put the paddles on the patient s chest Energy is being discharged internally Problem with the automatic test Do not touch the patient The machine is turning off Press the button in order to turn the machine back on Charging complete Children s paddles Treatment successful USB connect...

Страница 90: ...ipment s power supply charger cables and connectors in order to determine possible isolation or internal conductor ruptures Remember to check the status of the operational status indicator at least every 30 days see page 20 Operational status indicator Corrective Maintenance If the equipment needs repair this can only be done by INSTRAMED or its authorized representative otherwise this Warranty ce...

Страница 91: ... by the operator 01 Transport backpack code 14015 Description transport bag to transport the I on I on PRO with all accessories 01 USB cable A B code 10985 Description USB cable to connect I on I on PRO to the PC computer in order to access log events and ECG waveforms 01 CD manuals and software Instramed code 25277 Description CD containing User Manual and software necessary to access the log eve...

Страница 92: ...escription adhesive pads to be used in the Child s chest skin These adhesive pads will monitor and defibrillate the patient it is necessary 3 leads ECG cable code 26005 Description ECG cable with 3 leads with only the D2 derivation waveform with the purpose to only monitor the patient Charger for the internal battery code 13940 Description device to charge the rechargeable battery This battery cha...

Страница 93: ...ion to a power source use distinct from that described in the User manual or irregular working conditions Any attempt to violate adjust or repair this equipment by individuals not authorized by Instramed Indústria Médico Hospitalar Ltda will automatically invalidate this warranty This also applies in case of alterations made to this contract the fiscal receipt or to the equipment s serial number I...

Страница 94: ...www instramed com br 55 51 3073 8200 AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION AUTOMATED EXTERNAL DEFIBRILLATOR ...

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