User manual
Contents
1.2. o gt USB connector t t ISO 780 This side up T ISO 780 Fragile equipment a ISO 780 Maximum stacking of 4 units EG ISO 780 Keep away from rain i 90000 Minimum and maximum temperature x ISO 780 p T g ISO 7000 Minimum and maximum atmospheric pressure og ISO 7000 Minimum and maximum relative humidity HY 48 IEC TR 60878 Recyclable paper pa Directive 2002 96 CE Remains of electrical and electronic equipment Dispose of separately from other disposables brud Mark of conformity according to the European Community XXXX XXXX Directive 3ga EEC stands for the number of the certification authority IEC 60417 5031 Direct current k IEC 60417 5036 CF applied part defibrillation proof D IEC 60417 5010 On Off push push EN 980 Manufacturer cc rer EN 980 European representative SN EN 980 Serial Number 16 The Equipment Front Panel 01210 CPR 00 47 00000 2 Follow the instructions Place pads on the patient Manual 1 Touch screen presents operational 2 Operational status indicator information and allows for manual interaction with the device 3 Start button On the next pages you will find the detailed description of each component of the front panel 17 User manual The Equipment 1 Touch screen A IN AUTOMATIC MODE As default the device starts operating in AUTOMATIC MODE In this configuration the Isis PRO presents the following items on the sc
3. Event viewer window After downloading the information contained in the CardioMax memory the list of events stored by the device will be displayed in this area in chronological order Double click on an event to view it on the main screen Definition of events displayed in AED mode 47 User manual Operating Soft DEA INTERNAL DISCHARGE Power discharged internally due to pressing the start button for an excessive amount of time TREATMENT PERFORMED A shock was delivered to the patient SHOCK INDICATED Shock indicated due to the patient s ventricular fibrillation or ventricular tachycardia pattern SHOCK NOT INDICATED Shock not indicated on account of the electrocardiogram pattern not requiring a shock ANALYZING AED Analyzing 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 Equipment indicating the CPR procedure 48 User manual Operating Soft DEA Adjustments Click the settings button to access the screen that allows you to update the clock and set the sound level emitted by the speaker on the equipment In order to make changes the Isis Isis PRO device must be turned on and connected to the PC running Soft DEA via the supplied USB cable OD Sonne 3 22 INSTRAMED ADJUST adji update clock
4. volume level UWbWN Re OG 1 Update clock Click the update button to synchronize the clock with the time on the PC connected to the Isis Isis PRO device update 2 Volume level Using the mouse simply select one of the five volume presets for the equipment audio 49 User manual Operating Soft DEA Changing languages on rem a EN adjust LANGUAG ES r lanc ges in the device Portugu s Portugu s English English Espan l Espan l Pycckuh Isis Only T rk e Isis Only All CardioMax Only Under the in the SoftDEA option Change the language of the software interface Does not require a device to be connected Under the in the device option when an Isis Isis PRO device is connected Change the language of voice prompts emitted by the speaker on the device to the selected language Under the in the device option when a CardioMax device is connected The CardioMax language can be changed through the device s settings menu see page 48 General setup However if the voice prompts emitted by the CardioMax device show signs of degradation or defects this function can be used to restore the equipment s speech synthesis files Other buttons 1 Back Click this button to return to the previous page menu 50 User manual Operating Soft DEA 2 Exit Click this button to close Soft DEA 3 Q9 51 Pre
5. s resuscitation are very slim ATTENTION the CPR techniques shown in this manual are only refer ential and do not substitute the specialized presential training which is mandatory for emergency care professionals 41 Use in children Using the Isis PRO on children under 8 years old The Isis PRO can be used on children from the age of one year onwards However on patients from one year of age to eight years of age or patients who weigh less than 25kg some precautions must be taken e Use child pads Ifthe 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 Chest Shorter than Back 4cm 42 PC Connection Introduction The Isis PRO can be connected to a PC allowing the user access to new functions as View save in external media or print list of the last 100 events View save in external media and print ECG activity of the last two hours Change the operational configurations of the Isis PRO only for authorized technicians Check and update firmware version of the equipment only for authorized technicians Requirements Connecting the Isis PRO to a PC requires installation of the Soft DEA application in the computer to which a connection will be made This software is in the CD which comes with the equipment To install Soft DEA observe the following requirements Windows XP Windows Vista or W
6. also be interpreted according to the frequency as in the table below Number of beeps Failure description Two CPU failure Three Failure in defibrillation module Four Discharged battery Five General failure in battery module ATTENTION the device will not switch on if the battery is discharged or showing general failure In this case only the sound warning of the respective failure will be emitted 21 User manual The Equipment 3 Start button The Isis PRO offers exclusive technology which allows to operate the device completely safely with a single button v Switch on Analyze Deliver shock 1 press 2 press The start button has the functions of e Turning on the device Starting the automatic process of the patient s clinical analysis e Applying shock therapy active only when the automatic clinical analysis of the patient indicates the need for it More information in the Operation section NOTE it is not necessary to switch the Isis 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 follow ing message will be heard The device is being turned off Press the button in order to turn the machine back on Still there are three ways of switching it off manually pressing the start button for three seconds removing the pads or plugg
7. for the safety of cardiac defibrillators e EN 60601 2 4 2003 IEC 60601 2 4 2002 Medical electrical equipment Particular requirements for safety Particular requirements for the safety of cardiac defibrillators e ANSI AAMI DF80 2003 Particular requirements for the safety of cardiac defibrillators including automated external defibrillators e NBR IEC CISPR11 1995 Electromagnetic compatibility Irradiated and Conductive Device care Do not place the equipment where it may fall on the patient Do not lift the equipment by its cables or connections Place cables connected to the patient in order to restrict the possibility of strangulation Always keep the equipment and its accessories clean and well maintained If you suspect a fall or external damage do not use the equipment Cleaning and disinfection Instramed recommends cleaning and disinfecting the equipment and its accessories every three months or shorter periods whenever excessive dirt or contamination is noticed See the procedures for cleaning and disinfection below External parts of the equipment Remove the equipment from the electric current before cleaning it e Wipe the external part of the equipment with a cloth dampened with water and neutral soap or isopropyl alcohol e Never immerse the defibrillator in liquids Connection to other equipment When connecting the Isis PRO to any device ensure that the equipment is operating correctly before
8. the patient s skin The skin should be dry or electrical current leakage may happen enlarging burn area and reducing treatment efficiency Standards The Isis PRO was designed according to safety and performance standards such as NBR IEC 60601 1 1997 IEC 60601 1 1995 Medical electrical equipment Part 1 General Requirements for Safety e EN 60601 1 1990 Amendment A1 1993 A2 1995 A13 1996 IEC 60601 1 1988 A1 1991 A2 1995 Medical electrical equipment Part 1 General Requirements for Safety NBR IEC 60601 1 2 2006 IEC 60601 1 2 2004 Medical electrical equipment Part 1 2 General Requirements for Safety Collateral standard Electromagnetic compatibility Requirements and tests e EN 60601 1 2 2007 IEC 60601 1 2 2007 Medical electrical equipment General requirements for basic safety and essential performance Collateral standard electromagnetic compatibility Requirements and tests e ABNT NBR IEC 60601 1 4 2004 IEC 60601 1 4 2000 Medical electrical equipment Part 1 4 General Requirements for Safety Collateral standard Programmable electrical medical systems e IEC 60601 1 4 2000 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical 13 User manual Safety Information systems NBR IEC 60601 2 4 2005 IEC 60601 2 4 2002 Medical electrical equipment Part 2 Particular requirements
9. 0 kHz up to 80 MHz outside bands ISM 12 Conducted RF IEC 10V m 80 MHz to 800 MHz 61000 4 6 80MHz up to 2 5GHz EN m a 2 VP 80 MHz to 2 5 GHz Where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer and d is the advisable separation distance in meters m Field strengths established by RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference can occur around equipment marked with G the following symbol NOTE 1 At 80MHz and 800MHz the highest frequency range is 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 150kHz and 80MHz are 6 765MHz to 6 795MHz 13 553Mhz to 13 567MHz 26 957MHz to 27 283MHz and 40 66MHz to 40 70MHz gt The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range between 80MHz and 2 5GHz are intended to reduce the likelihood of mobile and portable communications equipment causing interference if inadvertently brought into the patient areas Therefore an additional factor of 10 3 is used in calculating the advisable separation distance for transmitters in these frequency ranges Field strengths establishe
10. PR for 2 minutes breathing No pulse no breathing recovery 38 Shock recommended Move away from the patient Activate AED Shock delivered Recovers pulse breathing CPR for 2 minutes User manual Operating in manual mode Simplified diagram of procedure in adults Layperson Unconscious Call emergency service Conscious RT ii Panting Check patient s condition Not breathing Place victim in a dry flat steady area Place pads Activate the Isis Restarts the cycle Restarts the cycle The Isis analyzes patient s condition Shock Shock NOT recommended recommended P Move away from the patient CPR for 2 minutes Activate AED It recovers breath and or movements It doesn t recover breath Shock applied and or movements It recovers CPR for 2 minutes breath and or movements 39 Applying CPR CPR cardiopulmonary resuscitation is a technique which consists in mechanical stimulation of the lungs and heart Through simple actions it aims to maintain the oxygenation of the brain avoiding irreversible damage 1 Lay the victim on his back on a hard flat surface 2 Run your fingers from the center of the victim s thorax descending until finding a bone that comes to a tip in the middle of the chest Sternum right above the stomach 3 Keep two fingers right below this point 4 Place the palm of your other hand above the two f
11. SR A E annie 09 Purpose EE EE EE ee eee 10 0 EE ERT 10 Fe 11 Qualified D ERE 11 POUL Ne NEA Landes odd e iA 11 Safety Information 12 110 EEE EE EN ET EET 12 Adverse Geek eske 13 StandaldS EE ER RT EE 13 Device EEE NE EE 14 eng and AISNEN av aszceetes vascteseeaceectacteececeseaeeasaeneeeecceaseecceereenente 14 Connection to other equipment L euuasuanammmunstmnnaianmedednnivnen 14 Disposing of the device s s cssseccccsesscssseseesescseseesseceecnsscenctensesteaeseeneaseenneneaeitens 15 Precaution EE E E E 15 Classification and 5 VIMO EEE EE EE 16 The Equipment 17 Rv 17 1 PN SE anemi did 18 2 Operational status indicator asdiesccardnsncarsicedgaansittashanssacincdvaiinatsianabatetunaniaaaasutes 20 S Start UNO EE EN NN 22 User manual Index SV EEE NE EE EEE EE 23 EE Te EEE EE EE 24 2 Battery power supply COMNeclor Ruymuemmnanmmunermnnidesnnmie dv 24 3 Battery COMP CNM CIN si recsiatauissayeveasinna seduidaamniedeancndeasheatatsuada Sabhelasdindiqsaiaceantnes 24 4 USB Connector sss eccszesctcraccstsacacatshasuedsacnastanchetuasnedcaadeasceaatadaaacaisasnnnitecentcadens 24 5 Disposable pads Compartment csccccscsssssssssssessesseeesseesseeescssaraneseees 24 6 Disposable pads OE nsrcrenamasnnisnenanuimiamemamaaucaatn 25 T Cabinet is a eriein aniei raai aA S Aa Ean aE i iaaa ne 25 Operating in AED mode 26 SIOD ENE EEE ENE e REESE 27 EEE ETER DE 28 SIED Se ee ne ee ee E 29 GJ ER EE EEE atmenaaat
12. TRAQYED 1 Graphic display button Click this button to display the ECG waveforms and event list stored on the device The displayed interval corresponds to the user defined time frame see item 7 on page 47 of this manual 45 User manual Operating Soft DEA Graphic display screen E SoDEA 3 22 INSTRAMED og ELECTROCARDIOGRAM 1 Download The set of information that is currently being viewed can be saved on the PC by clicking this button A window will open enabling the user to select the desired location in which to store the file download 2 Open Click this button to open a dea file that was previously saved on the computer 46 User manual Operating Soft DEA 3 Print Click this button to print the set of information that is currently displayed on the screen Use the printer driver dialog box to set printing options 4 PDF Click this button to generate a file showing the set of information that is currently displayed on the screen in pdf format The user must select the desired directory in which to save the file 5 Amplitude selection Allows the user to vary the ECG amplitude from 0 5 mV to 3 0 mV 6 Time frame Allows the ECG to be viewed in time frames from 1 second to 60 seconds 7 Time frame scroll Allows the ECG to be viewed throughout its time scale 8 Amplitude scroll Allows the ECG to be viewed throughout its amplitude scale 9
13. User manual ISIS PRO AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION INSTR AQYJE D Manufacturer Instramed Industria M dico Hospitalar Ltda ra Industrial Unity Rua Beco Jos Paris 339 Pavilh o 19 Postal code 91140 310 Porto Alegre RS Brazil Phone Fax number 55 51 3073 8200 Email comercial instramed com br Website www instramed com br European representative EC re Obelis S A Bd G n ral Wahis 53 1030 Brussels Belgium Phone 32 2 732 59 54 Fax 32 2 732 60 03 E mail mail obelis net 0499 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 Copyright 2013 Instramed The Isis PRO Instramed and its respective logos are trademarks of Instramed Industria M dico 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
14. asaenk 30 Sj EE TE RE 30 Simplified diagram of procedure in adults ccssssssseseceeccssssesssssessseeeeseeesseasass 31 Operating in manual mode 33 EE SE 34 NR EE EN 35 SE EE A E E 36 Se RE EN EE PE E 37 SOP Ira ES 37 Simplified diagram of procedure in adults ccscssssssseccecssseeseesseseseseseesseeeeacees 38 Applying CPR 40 VI User manual Index Use in children 42 Using the Isis PRO on children under 8 years old noovsvsvrvrervrvsrrrrrrrrrnererersrener 42 PC Connection 43 ict s t E E R 43 EG VL 101 ENE EE a E 43 OM DEA Re 44 Connecting the Isis PRO to a FC jncitnsnivinasuacumnimsnniiementanmen anit 44 Operating Soft DEA 45 SE Joel RE SEE EE ENE 45 1 Graphic display button siccasciiacdcasdsssccasacasestsvenasncdccacascesearasatecsacssastaiesaacaazatwnts 45 Graphic display SCreeRisnatemenmn tane A 46 1 Downoad RE N 46 EG EE NN NE 46 Fl 47 PI LE 47 5 Amplitude selection ccccccesesesssssssscsescsesescsssssesseseeeesesseseasacacaserseasasananeeees 47 THIS 6 EE a E ER 47 T ime frame SOON event 47 GLT 810 nanan 47 9 Event viewer WIC OW nes eeke atan aaria ai 47 GS EE ER ET 49 Nee fa 125010 EE EEE E NE 49 NEED 49 Changing NAVA EE EE 50 Vil User manual Index GI 1 IOUS RT EN EN ER ET EE 50 Fs 50 EE EEE 51 Precautions restrictions and warnings 52 Electromagnetic Compatibility warnings and notices 52 Electromagnetic METER 53 Electroma
15. cautions restrictions and warnings The Isis PRO is a device built according to NBR and IEC standards and therefore is completely safe for the patient and the user However all safety precautions described below must be followed The operation of the Isis PRO may be affected by the presence of electromagnetic power supplies such as electrosurgical equipment and computer tomography CT Electromagnetic Compatibility warnings and notices WARNING Using the Isis PRO requires special precautions concerning Electromagnetic Compatibility in compliance with the information contained in this manual Mobile and portable RF communications equipment such as a cellphones may affect the functioning of the Isis PRO Maximum length of accessory cables in order to comply with the requirements of Electromagnetic Compatibility is 2 5 m All parts and accessories which go with the equipment listed below follow the requirements for Electromagnetic compatibility Pair of disposable adhesive pads adult size e Pair of disposable adhesive pads child size e Power supply for charging internal battery e USB cable WARNING using cables and accessories different from the ones specified above except for cables and accessories sold by Instramed as replacement pieces may result in emission gain or immunity decrease of the equipment The Isis PRO must not be used too close to or piled over other equipment 52 User manual Precautions re
16. ch 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 only open the wrapping and remove adhesive electrodes immediately before use ATTENTION a pair of adhesive electrodes can hold up to 50 defibrilla tion discharges However once used even if only once it is advisable to replace them after 24 hours User manual Operating in AED mode Step 3 Analyzing heart rhythm Press START button The Isis PRO will automatically enter cardiac rhythm analysis mode and will start giving vocal instructions clearly and pausedly so that the user can perfectly understand them ATTENTION the patient must be on a steady surface Any movement during 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 equipment For replacements please contact Instramed 29 User manual Operating in AED mode Step 4 Treatment recommended Don t touch the patient Push the flashing button to treat the patient If the need for shock is detected the shock symbol will blink and the device will ask the user to press the start button again Press START button again The shock will be delivered ATTENTION the user must not touch the patient or cond
17. clinical use The equipment or accessories connected to the device must be certified according to the IEC 950 standard for data processing equipment 14 User manual Safety Information Disposing of the device Avoid contamination of the environment humans or other equipment by making sure to properly sterilize and 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 A Danger of EXPLOSION Do not use the Isis PRO in the presence of flammable anesthetics Risk of ELECTRICAL SHOCK Never open the equipment When necessary this must be done by authorized individuals Do not use the equipment in the presence of magnetic resonance devices This equipment was designed to be resistant to electromagnetic interference However equipment performance can be affected if in the presence of strong sources of electromagnetic interference or radio frequencies such as mobile phones radio communicators etc 15 User manual Safety Information Classification and Symbols Symbol Standard Description AN IEC TR 60878 Attention only use according to the instructions of this manual A IEC TR 60878 Careful dangerous high electrical voltage E IEC TR 60878 Power supply connector ke IEC TR 60878 Non ionizing radiation gt
18. cn koom m 200J of energy at 75R impedance H 1 _ PE EP EE FESTE EEE SVEEN Gil 500v P4 00ms User manual Specifications 200J of energy at 100R impedance Gil soov pTO oms 200J of energy at 125R impedance a soov a pliooms 200J of energy at 150R impedance ae petits Pre ee ee 65 User manual Specifications 200J of energy at 175R impedance fl 500V Pi10 oms 66 Inspection and maintenance Preventive Maintenance Instramed recommends that the Isis PRO be examined by a qualified technician every 12 months We recommend that you contact the manufacturer for more information about qualified and trained personnel in your area to perform preventive maintenance It is recommended that periodic inspections be performed on the equipment 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 certificate may no longer be valid No internal parts are to be fixed by the user ATTENTION periodic maintenance is needed independently of the equipment s use frequency 67 Warranty Certificat
19. cycles without loss of performance see battery specifications in chapter 8 When the device presents a drop in battery performance with low autonomy please request a new unit from Instramed s technical assistance The batteries are rechargeable Lithium lon Li ion The battery can be removed by the side opening in the lower left part identified by the symbol 3B see picture on page 22 Remove the screw unplug the connectors from the battery remove it and replace it with the new set observing the correct position of the connectors and making sure the lid remains steady The battery s shelf life is at least 500 cycles full charges and discharges Package contents Included items When opening the package please check whether all items below are present An Isis PRO automated defibrillator A power supply for charging internal battery A cable for connecting the power supply to the electric current A pair of disposable adult size adhesive pads A pair of disposable child size adhesive pads A user manual A first aid Kit A transport bag A USB cable ACD with the Soft DEA management Software Replacement parts You can ask Instramed for replacements of the following items consult Instramed for prices Shipping costs may be applied Batteries replacement Adult child adhesive pads replacement To request pieces and services please contact Instramed Index Introduction 09 IG pe 1 111 el EE
20. d by fixed transmitters such as base stations for radio telephones cell phone wireless mobile land radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with any accuracy In order to evaluate the electromagnetic environment due to fixed RF transmitters it is advisable to consider an electromagnetic site survey If the measured field strength in the site where the Isis PRO is used exceeds the level of RF compliance used above the Isis PRO should be observed to check if operation is normal If abnormal performance is observed additional procedures may be required such as reorienting or repositioning the Isis PRO 4 Over the frequency range 150kHz to 80MHz the field intensity should be less than V1 V m 55 User manual Precautions restrictions and warnings Electromagnetic immunity Life support function equipment Advisable separation distances between mobile and portable RF communications equipment and the Isis PRO The Isis PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the defibrillator can help to prevent electromagnetic interference by maintaining a minimum distance between the mobile and portable RF communications equipment transmitters and the Isis PRO as recommended below according to the maximum output power of the communication equipment x 150 kHz to 80 MHz 150 kHz to 80 MHz Maximum outp
21. e Instramed Industria M dico Hospitalar Ltda warrants the equipment described in this Certificate for 12 twelve months starting from the delivery date This warranty covers manufacturing or material defects that prevents proper functioning according to the specifications stated herein as long as the conditions presented in this Certificate are respected During the warranty period Instramed Industria M dico Hospitalar Ltda or its representative will repair or replace defective parts at no expense to the equipment s owner This warranty will no longer be valid if any damage occurs due to accident natural disaster improper connection 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 Industria M dico 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 Instramed Industria M dico Hospitalar Ltda is not responsible for the improper use of this equipment by people who are not familiar with its function or the techniques recommend for its proper use EQUIPMENT SERIAL NUMBER PURCHASE DATE FISCAL RECEIPT NUMBER 68 ISIS PRO AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION INSTRAMED www instramed com br 55 51 3073 8200
22. e a nonshockable rhythm Values measured with the AED using the specified database VFIVT Nonshockable Rhythms Shock INDICATED NO shock INDICATED Sensibility 97 05 Specificity 95 18 58 User manual Precautions restrictions and warnings Types of arrhythmia analyzed Nonshockable Sinus Rhythm Sinus Tachycardia Sinus Bradycardia Atrial Tachycardia Atrial Fibrillation Atrial Flutter Supraventricular Tachyarrhythmia Normal Rhythm with 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 Isis PRO meets IEC 60601 2 4 requirements for sensitivity gt 90 Shock VT The Isis PRO meets IEC 60601 2 4 requirements for sensitivity gt 75 Nonshockable rhythms The Isis meets PRO IEC 60601 2 4 requirements for specificity gt 95 59 Specifications General specifications Dimensions Weight Internal rechargeable battery Battery power supply charger Battery storage Pre adjusted defibrillation scales Internal memory storage Protection rating Classification 22 cm 8 7 in L 13 cm 5 1 in W 29 cm 11 4 in H Equipment 2 90 Kg 6 38 Ibs Type Li ion 14 4VDC 4 0 A h Life 10 hours in cardiac rhythm recognition mode fully charged battery or a minimum of 200
23. erformed when the device is switched on Should any problem be found the voice message problem with the automatic test will be emitted with the visual indicator of failure VISUAL INDICATOR Shows that the device is operating and ready for use Shows that the device DOES NOT HAVE ENOUGH BATTERY CHARGE TO OPERATE or has another internal defect Charge battery immediately If the indicator remains red please call technical assistance e Mains supply LED on means device is connected to the electric current e Mains supply LED blinking when in normal use means the battery needs charging In this state the Isis PRO guarantees at least 3 full energy discharges e Battery LED on means internal battery is being charged A blinking LED beside this symbol means full charge Notice EVEN WHEN THE BATTERY HAS BEEN FULLY CHARGED the operational status indicator will still be showing X The display will only change from X to W when the Isis PRO performs the auto test routine or if the device is turned on of by the user That is to change the display from X to Y user s intervention is neces sary after the battery has been completely charged 20 User manual The Equipment ATTENTION remember to check the status of the operational status indi cator at least every 30 days SOUND INDICATOR Along with visual indication the Isis PRO emits electronic beeps which can be identified by the user from a distance and can
24. for these kinds of cardiac dysrhythmia is electrical defibrillation a technique by which electrical shocks are applied to the anterior thoracic wall Obviously the success of defibrillation depends on the metabolic conditions of the myocardium The more the ventricular fibrillation lasts the greater the metabolic deterioration is and consequently the fewer chances of the electrical shock converting it into a steady rhythm However if it lasts shortly as in the cases of quickly assisted cardiac arrests shock response is almost always positive Therefore the 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 bi 45 phasic SHOCK Defibrillation is the electrical shock therapy responsible for reversing cardiac arrest caused by ventricular fibrillation or ventricular tachycardia without a pulse The Isis PRO uses the BIPHASIC SHOCK technology which is characterized by a current which is released in a direction and after a very short time reverts in the opposite direction During the defibrillation the whole myocardium is briefly depolarized by a strong positive impulse and a negative one of adjustable intensity Biphasic Truncated Exponential Shock This impulse is used for eliminating atrial and ventricular fibrillation and ventricular disturbances Compared to monophasic shock the fo
25. gnetic immunity General cecceeesteseeeeseeseenssseeeeteeereeeeeeteneeteneeres 54 Electromagnetic immunity Equipment with life support functions sseesessseeeeereeee 55 ECG analysis COON EEE EE 57 Types of arrhythmia analyzed iRun umemuneivimemeiesnresnssemsei estinvidtuae 59 Specifications 60 General Specificato EE EE riaa aieia 60 Environmental specifications RE 61 B T 0 EE EE ee ee ee ee ee 61 Precision of applied energy seen tena ieee tee eden cena 63 Patient s impedance response table csccssescsccsssssseesessesesesseseeseseseseesteeseacens 63 ECG rhythm recognition and detector table oo ceececeseeteieeeeetseeseeteeeteteteeeneeeee 63 Inspection and maintenance 67 Preventive Nebe iatpas nceasscaraiasaciantitaa esgasdaabvncsasnsnietasadieaiiedtalauaraiaedianciaienn 67 Corrective MAUMEN ANC veccscacuatisusasicincatsteensdcecensbsnatstvicednedaunssbicanatatecachsiavdiesenenieasnss 67 Warranty Certificate 68 Vill Introduction The Isis PRO is a new generation Semi Automated External Defibrillator AED Using Neural Network technology the Isis PRO guides by voice makes the diagnosis considers clinical variables and applies treatment safely with the touch of only a single button Designed for emergency care it is compact light resistant and easy to use In its PRO version the Isis offers the flexibility of the manual mode which allows the health care professional to select the pa
26. ice Conscious RT ii Panting Check patient s condition Not breathing Place victim in a dry flat steady area Place pads Activate the Isis Restarts the cycle Restarts the cycle The Isis analyzes patient s condition Shock Shock NOT recommended recommended P Move away from the patient CPR for 2 minutes Activate AED It recovers breath and or movements It doesn t recover breath Shock applied and or movements It recovers CPR for 2 minutes breath and or movements 32 Operating in manual mode The Isis PRO enables manual mode operation as a conventional defibrillator In this situation the device does not interfere with the treatment and the user is responsible for choosing the energy charging the charge and delivering the shock After confirming the mode change the Isis PRO ceases to emit sound and visual orientation in addition to the automatic safeguards against shocks 3 Activate manual mode Manual 2 Place pads Select 4 on patient q gt charge and charge energy Press button Press button to start cycle to deliver 1 6 shock 5 Shock delivered Start CPR Cardiopulmonary Resuscitation ATTENTION The use of the manual mode is the user s entire responsibil ity The use by non qualified professional may cause severe damage and even the patient s death 33 User manual Operating in manual mode Step 1 Before starting the
27. illator should ensure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient Burst IEC61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE U is the ac mains voltage prior to application of the test level Test Level ABNT NBR IEC 60601 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode phase phase 2 kV common mode phase ground lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for cycle of 5 seconds Compliance Level 6 kV contact 8 kV air 2 kV for power supply lines 1 KV for input output lines 1 kV differential mode phase phase 2 kV common mode phase ground lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for cycle of 5 seconds 54 Electromagnetic Environment Directives Floors should be made of wood concrete or tiles If floors are covered with synthetic material the relative humidity should be at least 30 The quality of the power supply should be that of a t
28. ime User manual Specifications Automatic after identifying an arrhythmia Front panel button when blinking 20s The rhythm detector and recognizer does not continue analyzing ECG after a shockable rhythm is detected 50 Joules lt 2 seconds 150 Joules lt 4 seconds 200 Joules lt 6 seconds 270 Joules lt 7 seconds The rhythm detector and recognizer does not continue analyzing ECG after a shockable rhythm is detected Pads size Maximum output voltage Maximum output current Adult area 82 cm 32 3 in Child area 30 cm 11 8 in 2000V 80A 250 62 User manual Specifications Precision of applied energy Selected Impedance Impedance every os 7 MK OK ai mo mo so ss ms so ssla an ters 2015 2085 2060 2038 1020 i770 sien Patient s impedance response table ee Shock inhibited lt lt 250nms s Ohms Shock inhibited gt 25 Ohms e lt 300 Ohms Shock delivered with a waveform adjusted to the patient s impedance gt 300 Ohms Shock inhibited ECG rhythm recognition and detector table PVR and VT All other ECG rhythms Sensitivity 97 05 Specificity 95 18 Tests carried out with the MIT BIH database 63 User manual Specifications Values on the Y axis refer to voltage volts and values on the X axis refer to time milliseconds 200J of energy at 25R impedance 200J of energy at 50R impedance si miii
29. in manual mode Step 3 Analyzing heart rhythm Press START button Press the MANUAL button on the device s screen Confirm this choice on the following screen The Isis PRO will switch to manual mode Auto Manual Auto Do you confirm switch If the user does not confirm the switch in 5 seconds the device will return to automatic mode 36 User manual Operating in manual mode Step 4 O80 CPR 00 00 O00 Manual Auto Use d and gt buttons to select the desired charge Use i gt button to store the charge Press co The shock will be delivered 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 applying CPR 37 User manual Operating in manual mode Simplified diagram of procedure in adults Healthcare professional Conscious Panting Unconscious Check patient s condition Not breathing Place victim Call emergency service on a dry flat and steady area Place pads Activate the Isis Restarts the cycle The Isis analyzes Restarts the cycle patient s condition Shock NOT recommended Recovers pulse C
30. indows 7 operating system CPU of 300 MHz or faster 02 GB free hard disk space Minimum 512 MB RAM 1 GB recommended CD or DVD ROM reader unit For physical connection to the PC One available USB port 43 User manual PC Connection Soft DEA Installation Insert the software CD in the CD DVD ROM drive If the autorun does not start automatically find the softdeasetup exe file in the CD and double click it Follow the installation instructions which will show up on the screen Connecting the Isis PRO to a PC Connect the equipment only after installing Soft DEA After the installation connect the device through the USB cable given The location of the device drivers to be installed will be required They can be found in this folder C Program Files Instramed Soft DEA DRIVERS Start the Soft DEA application On the language selection screen choose among Spanish English or Portuguese You only have to select a language the first time you start the software After the software reads the Isis PRO data see following section the ECG and the events list will appear on the software s screen ATTENTION the equipment must not be connected to the patient when communication via USB with the Soft DEA application occurs ATTENTION the equipment blocks any operation on the patient when communication via USB with PC occurs 44 Operating Soft DEA Startup screen SoftDEA show graphics INS
31. ing and unplugging the USB cable 22 User manual The Equipment Sides Speaker 5 Disposable pads compartment Battery power supply connector 6 Disposable pads connector Battery compartment 7 Cabinet recess USB connector 23 User manual The Equipment 1 Speaker The Isis 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 instructions or status messages Therefore it is extremely important that the speaker is unobstructed and the Isis PRO is in a position which allows the user to hear its instructions ATTENTION do not use the equipment inside bags which may prevent the user from hearing the spoken instructions 2 Battery power supply connector Connect the power supply to the electric current and then to this connector in order to charge the internal battery The equipment operates on voltage between 100 to 240 V in 50 60 Hz ATTENTION the device performs internal routine verifications which consume energy Even when the equipment is not in use a full charge is recommended every 20 days 3 Battery compartment It holds the internal batteries of the equipment The reset button is also placed in this compartment in case restarting the equipment is necessary ATTENTION in case of battery replaceme
32. ingers 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 arms stretched Put pressure on the victim s thorax compressing the chest and then releasing it Follow the BEEPS emitted by the Isis PRO which mark the rhythm of the compressions Every 30 compressions apply 2 mouth to mouth ventilations 7 Performing mouth to mouth breathing 40 User manual Applying CPR Place one hand on the back of the victim s neck and lift it place your other hand on the victim s forehead and force the head back in order to let the air through Close the victim s nostrils with the fingers which are on the forehead Take a deep breath and place your open mouth on the victim s mouth if it is a child also cover the nose with your mouth Force air inside the victim s lungs until the thorax inflates as in normal breathing Allow the person to release the air by removing your mouth 8 At every interval 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 Isis PRO After the third complete CPR and shock cycle chances of the patient
33. isks The information contained in this manual belongs to Instramed and cannot be used fully or in part without expressed written consent Instramed has the right to make any changes to improve this guide and the product without prior notice This guide is a part of the Isis PRO and must be kept for further reference 11 Safety Information A ATTENTION The following factors may cause ECG misinterpretation e Wrongly placed pads e Patient s movements e Pacemaker it may lessen the precision of the cardiac arrest detector Radio frequency interference including mobile phones e Excessive hair or wet skin in the application area of the electrodes e Pieces of clothing between skin and pads Warnings IMPORTANT This equipment may only be operated by qualified technical personnel Read this guide carefully before using the equipment 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 SURFACE WHICH IS IN CONTACT WITH THE PATIENT DURING THE DEFIBRILLATION WARNING DO NOT CONNECT THE PATIENT TO THE ISIS PRO WHEN THE EQUIPMENT IS CONNECTED TO THE ELECTRIC CURRENT WARNING THE PATIENT MUST BE COMPLETELY STILL DURING THE CARDIAC RHYTHM ANALYSIS PHASE DO NOT GIVE CARDIAC MASSAGE AT THIS POINT WARNING ri
34. llowing advantages can be mentioned regarding biphasic technology e Greater efficiency at ending ventricular fibrillation e Lesser damage to the myocardium through the use of lesser energy intensity with attenuation of subsequent myocardial dysfunction e Fewer incidence of refibrillation 10 User manual Introduction Source Sociedade de Cardiologia do Estado de Sao Paulo SOCESP Revista Socesp V 11 no 2 Use criteria A The Isis PRO as well as any other Automated External Defibrillator must only be used if the following circumstances as a whole are presented e Unconscious victim or unresponsive to verbal or physical stimulus Not breathing No pulse for professionals Other important considerations regarding the use of the Isis PRO Not recommended for children under one year old e Pacemakers may affect the device s efficiency e Medicines in adhesive form must be removed before starting defibrillation e Hypothermic patients may not respond well to defibrillation 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 Isis PRO Automated Defibrillator series works alerting the user to safety r
35. nt use original replacements from Instramed supplied by its authorized distributors 4 USB Connector Used for connecting the equipment to a PC see chapter 5 5 Disposable pads compartment Used for storage of disposable pads used in shock delivery ATTENTION the disposable pads have an expiration date Check the expiration date on the wrapping and in case they have not been used during this period replace them with another pair 24 User manual The Equipment ATTENTION only use original pads provided by Instramed Not following this observation may prevent the equipment from working 6 Disposable pads connector Used for connecting disposable pads to the Isis PRO ATTENTION whenever the pads set is replaced remember to keep a new pair already connected to the equipment 7 Cabinet recess Used for attaching the cord of the disposable pads to the equipment s body preventing the cord from getting loose When installing a new pair of pads push the connector s cord in its narrowest part inside the cabinet recess and then twist to fix it 25 Operating in AED mode When in AED mode Automated External Defibrillator the Isis PRO identifies arrhythmias and selects the energy charge automatically Below you will find a simplified introduction to how the Isis PRO operates Be sure to carefully memorize the detailed guide on the next pages before operating the equipment 3 Equipment analyzes patien
36. operation please call the emergency service If the disposable pads have not been connected to the Isis PRO yet attach the 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 mo ment 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 34 User manual Operating in manual mode Step 2 P Remove pads from their wrapping and peel off the film protecting the adhesive Place pads on the patient according to the picture above keeping adhesive area in contact with the skin This position allows the electric current to circulate from one pad to the other thus reaching the whole thoracic cage ATTENTION the area in contact with the pads must be dry 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 only open the wrapping and remove adhesive electrodes immediately before use ATTENTION a pair of adhesive electrodes can hold up to 50 defibrilla tion discharges However once used even if only once it is advisable to replace them after 24 hours 35 User manual Operating
37. rameters of shock delivery treatment such as selecting charge up to 270 Joules Through a touch screen with excellent contrast and visualization area the user selects the operation mode and charge while visualizing the ECG curve The interface is simple and self explanatory Characteristics A Semi automated Artificial Intelligence accurate diagnosis of the patients 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 just one button Orientation by voice and indicator lights Internal recording of events PC connection via USB Software for connection download and data management via PC Biphasic shock Automatic self diagnosis of functions and battery Easy access to pads for use and replacement Use in hospital or extra hospital environments including emergency rescue units OD Hy Neural Network Technology 09 User manual Introduction Purpose The defibrillator is a device used for treating cardiac arrhythmias situations in which the heart loses the ability of keeping steady heartbeats blood stops being pumped and oxygen and nutrients do not get to the organs starting a degenerative process known as biological death Among the most common cases of cardiorespiratory arrest are ventricular fibrillation VF and ventricular tachycardia VT and the most efficient treatment
38. reen when connected to the patient 080 CPR 00 00 Manual Analyzing Do not tou 1 Heart beats per minute 2 ECG curve 3 Automatic mode button 4 CPR interval counter counts the interval between discharge delivery helping in the CPR Cardiopulmonary resuscitation massage 5 Orientation message 6 Icon indicating the defibrillation stage 7 Battery status 18 User manual The Equipment B INMANUAL MODE If the user decides to switch to manual mode the equipment will function as a standard defibrillator In this situation it will be necessary to select the appropriate charge according to the type of patient without the Isis PRO s intervention or orientation Energy charging delivering the shock and CPR interval counting will be the user s entire responsibility 080 CPR 00 00 Manual Auto 1 Heart beats per minute 2 ECG curve 3 Manual mode button 4 CPR interval counter in manual mode this indicator shows the continuous counting since the beginning of the operation 5 Orientation message 6 Icon indicating the defibrillation stage 7 Battery status 19 User manual The Equipment 2 Operational status indicator The Isis PRO performs a full auto test weekly allowing the user to know the operational status of the device This status is informed by a visual indicator see picture below voice messages and sound signals The automatic test is also p
39. shocks at 200 Joules Time to fully charge the battery when fully depleted 5 hours AC 100 240 V 50 60 Hz Consumption maximum Electric mains supply 1A Output 24 VDC 1 5A Storing the battery for a long period of time in temperatures higher than 35 C 95 F will reduce its capacity and shelf life Adults 1st shock 150J next shocks 200J Children 50 J 100 events or 2 hours of ECG recording IPXO Internally Energized Equipment CF type 60 Functioning mode Maximum time from rhythm analysis beginning to discharge readiness Maximum time from rhythm analysis beginning to full discharge readiness Environmental specifications Temperature Humidity Defibrillator Waveform Shock application Commands Scales for defibrillation Adults children Selection User manual Specifications Continuous Operation 20s 25s Operational 0 to 50 C 32 to 122 F Storage 0 to 70 C 32 to 158 F Operational 10 to 95 RH without condensation Storage 10 to 95 RH without condensation Biphasic truncated exponential Wave shaped parameters adjusted according to the patient s impedance By means of multifunctional adhesive pads Front Panel Button on off Adult 150 and 200 J Child 50 J Automatic due to the size of the pads 61 Charge command Shock command Maximum time from rhythm analysis beginning to discharge readiness Maximum charging t
40. sk of explosion if the equipment is operated in the presence of flammable liquids or gases WARNING always check the general state of the equipment the battery and the accessories before using it NOTICE each and every repair to the equipment can only be done by Instramed s authorized technical assistance centers NOTICE The use of the Isis PRO is restricted to one patient at a time NOTICE The applied parts are protected against defibrillation discharge during discharge there may be baseline variation 12 User manual Safety Information NOTICE Avoid connecting the patient to several items of equipment at the same time The limits of current leakage may be exceeded NOTICE The applied parts intended to come into contact with the patient have been evaluated and comply with the directives and principles of ISO 10993 1 NOTICE when removing the equipment from the package carefully verify if there is any abnormality or visible damage in the device or its accessories caused by impact or mishandling during transportation In case of irregularities please contact Instramed NOTICE disposable accessories and any other components must be disposed of according to the norms of hospital waste disposal Adverse effects Superficial burns may occur to the patient s skin on the area in contact with the electrodes To minimize this effect apply the pads soon after removing their protective envelope and press them firmly to
41. strictions and warnings Electromagnetic emissions Directives and manufacturer declaration electromagnetic emissions The Isis PRO is intended for use in the specific electromagnetic environment below The customer or user of the defibrillator is advised to ensure that it is used in such an environment Tests Compliance Electromagnetic environment directives The Isis PRO only uses RF power for its internal functions RF Emissions ABNT NBR IEC CISPR11 Nevertheless its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions ABNT NBR IEC CISPR11 The Isis PRO is suited for use in any establishment This Harmonics Emissions IEC 61000 3 2 includes residential establishments and those directly connected to the public network of distribution of low voltage Voltage fluctuations flicker emissions IEC electricity which supply domestic use buildings 61000 3 3 Complies NOTE It is of paramount importance that the true efficacy of the RF shielding and the true attenuation of the RF filter of the shielded location are checked to ensure that they meet or exceed the minimum values specified 53 Electromagnetic immunity General User manual Precautions restrictions and warnings Directives and declaration of the manufacturer electromagnetic emissions The Isis PRO is intended to be used in the specific electromagnetic environment below The user or customer of the defibr
42. t s condition Place Analysis is ads on concluded 2 Patient shock is 4 recommended Press button to Press button to start cycle deliver shock 1 5 Shock delivered start CPR cardiopulmonary resuscitation 6 The energy delivered is preadjusted The user cannot change this protocol For adult electrodes 1st shock 150J the following 200J For child electrodes 50 J 26 User manual Operating in AED mode Step 1 Before starting the operation please call the emergency service If the disposable pads have not been connected to the Isis PRO yet attach the 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 mo ment 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 27 User manual Operating in AED mode Step 2 P Remove pads from their wrapping and peel off the film protecting the adhesive Place pads on the patient according to the picture above keeping adhesive area in contact with the skin This position allows the electric current to circulate from one pad to the other thus reaching the whole thoracic cage ATTENTION the area in contact with the pads must be dry The presence of too mu
43. this present device identified by the serial number and may not be in whole or in part evaluated recompiled or altered in any way isis pro user manual eng r1 5 2014 09 23 Battery use ATTENTION Observe the battery charge maintenance instructions First use The batteries are rechargeable Lithium lon Li ion Before using it for the first time the device must receive a full battery charge In order to do this the equipment needs to be connected to an electric current for at least eight hours To charge the battery connect the charger to the lateral connector in the device B and then to the electric current Time for full battery charge 5 hours The device blocks any operation on the patient when connected to the electric current Occasional use Even when disconnected stand by the Isis PRO executes internal routines checking the status of the equipment In spite of this procedure entailing a low power consumption the battery charge may be consumed Therefore whenever the device has not been connected to an electric current for more than 20 days it is advisable to execute a full battery charge If this procedure is not performed there is a risk of draining the battery and consequently being unable to use the Isis PRO in its portable configuration not connected to the electric current Replacement Every battery has a determined shelf life which is the possible quantity of full charge and discharge
44. uctive surfaces 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 Isis PRO will announce TREATMENT NOT RECOMMENDED Check whether there were patients movements during the analysis If there were restart the process If not remove pads and start the CPR cardiopulmonary resuscitation procedure Details on the next section Step 5 After the shock start the CPR procedure See more in section 6 applying CPR 30 User manual Operating in AED mode Simplified diagram of procedure in adults Healthcare professional Conscious Panting Unconscious Check patient s condition Not breathing Place victim Call emergency service on a dry flat and steady area Place pads Activate the Isis Restarts the cycle The Isis analyzes Restarts the cycle patient s condition Shock NOT recommended Recovers pulse CPR for 2 minutes breathing No pulse no breathing recovery 31 Shock recommended Move away from the patient Activate AED Shock delivered Recovers pulse breathing CPR for 2 minutes User manual Operating in AED mode Simplified diagram of procedure in adults Layperson Unconscious Call emergency serv
45. ut pr outside ISM bands outside ISM bands 80 MHZ10 800 MZ of the transmitter W d 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 80MHz and 800MHz the separation distance for the highest frequency range is applied NOTE 2 The ISM industrial medical and scientific frequency bands between 150kHz and 80MHz are 6 765MHz to 6 795MHz 13 553 MHz to 13 567MHz 26 957MHz to 27 283MHz and 40 66MHz to 40 70MHz NOTE 3 An additional factor of 10 3 is used in calculating the advisable separation distance for transmitters in the ISM frequency bands between 150kHz and 80MHz and in the frequency range 80MHz to 2 5GHz to reduce the likelihood of interference that mobile portable communications equipment could cause if taken inadvertently to patient areas NOTE 4 These directives may not be applicable in all situation Electromagnetic transmission is affected by the absorption and reflection of structures objects and people 56 User manual Precautions restrictions and warnings ECG analysis algorithm Databases used for the VF VT recognition algorithm tests MIT BIH Arrhythmia Database MIT BIH Atrial Fibrillation Database MIT BIH Supraventricular Arrh
46. ypical commercial or hospital environment The quality of the power supply should be that of a typical commercial or hospital environment The quality of the power supply should be that of a typical commercial or hospital environment If the user of the defibrillator requires continued operation during power interruption it is advisable that the Isis PRO is supplied by an uninterrupted power source or a battery Power frequency magnetic fields should be a characteristic levels of a typical commercial or hospital environment User manual Precautions restrictions and warnings Electromagnetic immunity Equipment with life support functions Advisable separation distances between mobile and portable RF communications equipment and the Isis PRO The Isis PRO is intended to be used in the electromagnetic environment specified below The customer or user of the defibrillator should ensure that it is used in such an environment Test Level of ABNT NBR Immunity Test IEC 60601 Compliance Level Electromagnetic Environment Directive Portable and mobile RF communications equipment should not be used near any part of the Isis PRO including cables with a separation distance less than the one advised calculated using the equation applicable to the frequency of the transmitter Advisable Distance of Separation 3 Vrms 150 kHz up to 80 MHz outside Conducted RF IEC Pands ISM 61000 4 6 10Vnm 15
47. ythmia Database European Society of Cardiology Arrhythmia Database Creighton University Arrhythmia Database Test report 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 sensitivity and specificity calculations PINT Nonshockable Rhythms Shock INDICATED NO shock INDICATED A Sensibilidade A C Especificidade 5725 57 User manual Precautions restrictions and warnings Sensitivity is the equipment s percent ability to correctly identify a shockable rhythm Specificity is the equipment s percent ability to correctly identify a nonshockable rhythm A True Positive B False Positive C False Negative D True Negative A true positive A is the equipment s ability in measurement 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 nonshockable rhythm A true positive D is the equipment s ability in measurement units to correctly recogniz
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