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CardioStart Defibrillator Monitor

1. 84 US DEFIB TIT MEDICATECHNOLOGES VC CARDIOSTART Defibrillator Monitor 9 4 BASELINE DISPLACEMENTS This trace disturb causes an ECG baseline displacement regarding the central zero of the graphic center of the printing paper taking a while to return to the normal condition depending on the order of the internal filters of the equipment The trace can momentarily raising difficulties to the exam figure B4 The main causes are related as follows Inappropriate connection of the electrode to the patient with little gel or using worn out electrodes Fixation tape of the electrodes poorly positioned or without adherence Presence of strange particles dirt for example between electrode and patient skin Rupture in the junction between patient and electrode In this case normally appears abrupt oscillations between the graphic extremities with delay on the return to the baseline Image B4 ECG with oscillation on the baseline drift 9 5 MOVEMENT ARTIFACTS The movement artifacts have its origin on the interface of contact between the electrode the conductor gel and the patient skin Actually the electrode works not only as an electric sensor but performs a more complex electrochemical transduction the frequency scouted by the equipment is placed between 30 and 300 ppm with a 3 accuracy transforming the ionic activity of the skin surface that reflect the internal electrical g
2. Image 2 Simplified Adult CBV Algorithm Non responsive no breathing or with abnormal breathing just gasping rithm shock Compress quickly indicated ATA Compress tighly Check the Image42 Reproduced from American Heart Association Highlights of American Heart Association 2010 for CPR and ECC Guidelines Translated from the Portuguese version 19 1 REFERRALS This text was based in the new guidelines for CPR of AHA available in http www heart org idc groups heart ublic wcm ecc documents downloadable ucm 317343 pdf 20 HEART PACE DETECTOR AED MODE OPTIONAL The CARDIOSTART DEFIBRILLATOR MONITOR is prepared to recognized and indicate cardiac rhythms defibrillation of ventricular tachycardia VT of several frequencies and QRS width and rhythms of ventricular fibrillation VF of several amplitudes AUTOMATICALLY remaining to operator to connect the Pads on the patient chest 63 US DEFIB IW MEDICANTECHNOLOGIES OC CARDIOSTART Defibrillator Monitor The rhythm detection system of the CARDIOSTART DEFIBRILLATOR MONITOR analyses the patient ECG and informs in case the defibrillator has detected a rhythm that needs to be submitted to shock and contrariwise The system allows a person without the training of the ECG rhythm to use defibrillation actions for ventricular fibrillation and ventricular tachycardia in victims without pulse The rhythm detection system of the CARDIOSTART DEFIBRILLATOR MO
3. Continuous Current Defibrillation proof BF type applied part Defibrillation proof CF type applied part This side up indicates the correct position in which the box should be transported Fragile indicates that the package should be transported and handled carefully Keep it dry indicates the package should be kept in a dry place Minimum and maximum temperature Number 5 indicates maximum pilling of five units Indicates medical equipment and therefore it deserves special treatment Indicates composition with recyclable raw material US DEFIB TIT MICA TECHNOLOGIES VC CARDIOSTART Defibrillator Monitor Representative in the European Community ao Symbol of compliance with the European Community Electrical and Electronic Equipment Waste Dispose it separate from other objects 3 MEASUREMENT UNITS Symbols Unt Description hz rom bpm Frequency Hertz breeding per minute beat per minute pulses per opm minute Volts millivolts m s mm s bps Speed Meter per second millimeter per second beat per second m liters per minute Q Q impedance Ohms gt gt O Jo Enegy Joues gt Cubic meters cubic millimeters 4 ACRONYMS USED IN THIS USER MANUAL CLAS Cardiology Life Advanced Support AHA American Heart Association BLS Life Basic Support IDM Implantable Defibrillator Monitor ECG Electrocardiogram VF Ventricular Fibrillation Hb Hemoglobin Hbc
4. Hemoglobin concentration HbOQ Oxihemoglobin CHbO gt 2 oxihemoglobin concentration PRI Printer INCOR Heart Institute LDE Light Diode Emissary 10 US DEFIB TIT MEDIATECHNOLOGES VC CARDIOSTART Defibrillator Monitor LCD Liquid Crystal Display PM Pacemaker SAN Sinu atrial Node ABP Arterial Pressure CRA Cardio Respiratory Arrest NIBP Non Invasive Blood Pressure IBP Invasive Blood Pressure DBI Defibrillator CPR Cardiopulmonary Resuscitation BSC Brazilian Cardiology Society SPO Oxygen Saturation VT Ventricular Tachycardia ICU Intensive Care Unit VOO Pacemaker Asynchronous Mode VVI Pacemaker on Demand Mode 5 THROWING AWAY THE EQUIPMENT To prevent the contamination of the environment people or other equipment be sure to have disinfected and decontaminated the equipment properly before you dispose of it according to the national laws for equipment with electrical content and electronic parts To discard parts and accessories follow local regulations concerning medical waste Electrical and electronic equipment waste Discard it separately from other objects of the establishment Refer to local regulations for waste disposal consult the European Directive 2002 96 EC 6 DESCRIPTION OF CARDIOSTART DEFIBRILLATOR MONITOR AND ITs COMPONENTS 6 1 PRESENTATION The CARDIOSTART DEFIBRILLATOR MONITOR is a portable with dual phase equipment able
5. ATTENTION Do not use cuffs and or pipes with water inside because there is risk to damage the equipment If liquid infiltration to the equipment occurs turn it off from the power grid store it and call a technician to check the equipment NIBP cuff must be placed on the patient according to the following instructions NIBP Module M nA Fi The guideline must be SQ CEE restricted to He wai t Correct postioning indication of the indicated space within cuff on the patient the two white arrows Image 34 Adjusting the cuff to the patient 52 US DEFIB Y MICA TECHNOLOGIES VC CARDIOSTART Defibrillator Monitor 17 4 ADAPTING PACEMAKER PADDLES Connect the extension cable on the paddles PADDLEs and then insert the other end connector on the defibrillator monitor terminal Insert the connector and fasten with moderate pressure So the pacemaker will be ready for application Image35 Paddles Positioning Variations of Pacemaker on the patient The stimulation electrodes should be positioned in a way that doesn t interfere in a possible defibrillation Normally non invasive stimulation is performed in the configuration Apex Front or Front Back Nevertheless is recommended the configuration Front Back to ease the defibrillation procedure 17 4 1 PACEMAKER USE INSTRUCTION When equipment is turned on the pacemaker module begins a self test routine In this routine it checks high voltage circuit and output pulses pa
6. ECG signal 15 Auto Charge Enables YES or disables NO the automatic charging of the defibrillator 16 Sel by Paddles Enables YES or disables NO the command by the paddles buttons 17 Date Set the day month year NOTE When you select the AED Key the equipment will enable the AED MODE automatically In order to exit the AED MODE press the AED key again 16 1 3 ECG SETUP MENU Exit Derivation Filter 60Hz Filter 35Hz Tachycardia Bradycardia Speed Gain Beep Alarm 1 Exit Returns to previous Menu 2 Derivation Defines the electrocardiogram derivation to be presented on display CAL calibration D1 D2 D3 AVR AVL AVF V 3 Filter 60Hz Enable yes or disable no 60 Hertz filter 4 Filter 35Hz Enable yes or disable no 35 Hertz filter 44 US DEFIB MEDICAL TECHNOLOGIES CARDIOSTART Defibrillator Monitor 5 Tachycardia Defines the bom value for alarm operation in tachycardia 100 200 6 Bradycardia Defines bpm value for alarm operation in bradycardia 30 60 7 Speed Select the sweeping speed of ECG for 12 5 25 or 50mm s 8 Gain Select the ECG amplitude for N 2 N or 2N 9 Beep Enable yes or disable no the synchronism beep with QRS complex of ECG signal 10 Alarm Enable yes or disable no any ECG alarm Note Gains N2 0 5 cm N 1 0 cm and 2N 2 0 cms 16 1 4 PACEMAKER SETUP MENU Pacemaker Exit Mod
7. Exit or press the Exit shortcut key located on the panel on the side of the navigation button NOTE In the modules Configuration Menu only the ones that are installed in the Cardiostart Defibrillator Monitor will appear configuration options Rotating the navigation key without pressing it will allow the selection of the charge to be released in case of treatment 1 to 200 joules or other as requested 16 1 1 SETUP SCREEN Exit Setup ECG Pacemaker SPO2 Printer NIBP IBP Capnography Ventilation Drugs 16 1 2 SYSTEM SCREEN Exit AED Mode sync ON Auto Charge Sel by Paddles Volume Alarm 43 US DEFIB TIT MEDICATEGHNOLOGES VS CARDIOSTART Defibrillator Monitor BPM Volume Volume Key Beep Key Date Time Language 2 Exit Returns to the previous menu 3 Alarm Vol Set the alarm volume mute 001 max 009 4 BPM Volume Sets the beeper volume BPM 001 mute 009 max 5 Volume key Sets the volume of the beeper keyboard mute 001 max 004 6 Beep key Enables YES or disables NO the beep sound on the keyboard 7 Language PTG Portuguese English ENG SPA Spanish 8 Year Changes the Year 9 Month Changes the Month 10 Day Changes the Day 11 Time Changes the Time 12 Minute Changes Minutes 13 AED Mode Enables YES or disables NO AED mode 14 Sync ON Enables YES or disables NO the synchronism with the QRS complex of the
8. differences in tracing tones of a manufacturer or different batch 56 US DEFIB Y MEDIATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor 17 6 1 INSTRUCTIONS TO PLACE THERMAL PAPER IN THE TR 50 OR SP 48 PRINTER 1 Press the cover latch as shown in the image 2 Move the lid until it is positioned at 70 as shown in the image 3 Enter the print platen in the loop and print side up 4 Drag out the paper centering in the direction shown in the image below 5 Lift the printer cover ensuring that it doesn t lock 6 Set the print paper again so that it centralizes with the printer 7 After the correct positioning of the paper press the printer cover until it locks After locking the lid the equipment will be ready for use If the paper does not move properly during em printing repeat the procedure Image37 Placing the Paper on the Printer 17 7 USING CAPNOGRAPHY AND SENSORS CARDIOSTART DEFIBRILLATOR MONITOR can use either the nasal line or intubated for the Ccapnography In case of capnography use on intubated patients one of the adaptors shown in the images below should be used The capnography can be damaged due to the reuse of the water filter Follow the instructions of accessories use supplied by its manufacturer The filter should be replaced at each patient according to the use instructions of the manufacturer 57 US DEFIB Y MEICANTEGHNOLOGES VC CARDIOST
9. external and internal electrodes adult pediatric or neonatal Mobile Crash Cart Equipment support 14 US DEFIB Y MMICANTEGHNOLOGES OC CARDIOSTART Defibrillator Monitor The images contained herein are merely illustrative 7 3 ACCESSORIES PHOTO fe f J Image2 5 Way Patient Cable permanent use accessory Image3 3 Way Patient Cable permanent use accessory optional Image4 ECG Contact Gel disposable content Image5 Disposable ECG Electrodes 15 US DEFIB ESEO VEREEN CARDIOSTART Defibrillator Monitor Image6 Shock Electrodes for defibrillation and Image7 Pediatric Disposable Adhesive Electrodes cardioversion shock permanent material Paddles AED MODE single use material e SS Image8 AdultDisposable Adhesive Electrodes Paddles External paddle Model F7959W single use Image9 Capnography Intubation Line optional accessory material Image10 Capnogr abies adaptor Optional Image11 Capnography nasal line optional accessory 16 US DEFIB MEDICAL TECHNOLOGIES CARDIOSTART Defibrillator Monitor Image12 Adult oximetry sensor permanent use Image13 Adult Pediatric Neonatal oximetry sensor accessory optional permanent use accessory optional Image14 Ear Oximetry Sensor permanent use Image15 Disposable Oximetry Sensor Optional accessory optional Image16 Invasive pressure transducer optional Image17 Medex Inva
10. impedance indicator is only shown in the display when using the ECG reading via shock PADDLES The impedance index is divided into 4 four sections where the ideal operating section is Section 2 impedance range from 30 c to 150 c Impedance Range Description Presented Color c Contact 1 20 lt IMP lt 300 GOOD 2 30 lt IMP lt 150 GREAT 3 150 lt IMP lt 180 REGULAR 4 180 lt IMP Low Red Impedance Indicator Section 1 Section 2 Section 3 Section 4 In addition to the indicator in the display of the equipment the STERNUM paddle contains an indicator of contact with the patient Image 22 This led assists in positioning the paddles at the time of the shock Green Good Contact Red blinking Low Bad Contact 35 US DEFIB IW meoir TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor Image29 Indicator of paddle contact to the patient 10 COMPACT FLASH CARD SLOT OPTIONAL It is possible to record the curves date and time of the events occurred during the use of CARDIOSTART DEFIBRILLATOR MONITOR is this just connect the memory card in the indicated location The input connector only allows the card to be connected to the right side it is not necessary indication of the mating Each time the equipment is initialized the information will be recorded for approximately 100 hours of continuous recording In order to view the information recorded on the card just disconnect it from t
11. interference or may interrupt the operation of near equipment It may be necessary to take migratory actions like re orientation or relocation of the DEFIBRILLATOR MONITOR or the shielding of the location 14 CARE WHEN APPLYING DEFIBRILLATION CARDIOVERSION Do not place the Paddles directly on ECG electrodes In patients with pacemakers some care should be taken in order to prevent damage to the device and to the patient himself o The applied energy should be the lowest possible o Check pacemaker right after defibrillation o Keep proper distance between the generator and the patient pacemaker and the DEFIBRILLATOR MONITOR paddles A N the protection against the defibrillator discharge effects is located in the intern modules of the equipment The cable electrodes and accessories don t have protection against burns caused by the use of high frequency equipment 15 TRIGGERING TEST OF DELIVERED ENERGY The CARDIOSTART DEFIBRILLATOR MONITOR is equipped with borne for energy trigger testing which are positioned on the side of the paddle attachment places The User must select a charge advisable a load between 10 and 50 joules the 1 key Selection press the 2 key Charge after issuance of the beep that will identify that the charge is ready for triggering run the process of shock triggering with the paddles placed upon the borne applying a pressure of about 10 kg As soon as the trigger buttons are pressed a lumi
12. is undetermined when it is between 0 and 69 The oximetry used in the equipment measures the functional saturation where oxygenated hemoglobin is expressed as a percentage of the hemoglobin that can transport oxygen The oxygen saturation SPO2 is defined by the concentration rate of two of the main forms of blood hemoglobin the arterial hemoglobin or oxyhemoglobin HbO2 and the concentration of HbO2 unsaturated hemoglobin Hb i e cHbO2 cHb The oxygen saturation is expressed in percentage and calculated by the formulae below 25 US DEFIB Y MICANTEGHNOLOGES VC CARDIOSTART Defibrillator Monitor SPO2 cHbO2 X 100 CHbO2 Hbc Available technologies optional Masimo Nellcor 8 6 PACEMAKER TECHNICAL SPECIFICATION AND CHARACTERISTICS The external pacemaker was designed to stimulate heart in cases of rhythm disturbance and flaw to conduct internally electric pulse It is used in cardiac surgeries aS emergency cardiac pacemaker Some indicated transthoracic applications of pacemaker are Treatment of symptomatic bradycardia or bradyasystole during emergency During and after cardiac surgery To favor the insertion of a transvenous stimulator electrode amp 6 1 PACEMAKER CHARACTERISTICS The external pacemaker applies in the heart a square wave of variables frequency and current intensity Its function is to stimulate the organ to perform the heartbeat The pacemaker uses electrical stimulation to reproduce
13. line Disposable tube adaptor 29 US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor 8 10 ST SEGMENT ANALYSIS The acute myocardial infarction is a necrosis of a part of the heart muscle by interrupting the blood flow in the coronary arteries Early diagnosis is a fundamental factor for the reduction of mortality and of the possible consequences for the patient One of the most accurate for this diagnosis is the identification of anomalies in ST segment though the electrocardiogram Patients with ST Segment positive deflection may be suffering a myocardial infarction and patients with ST Segment depression in aVR and v1 can be suffering a myocardial ischemia malnutrition of a certain part of the myocardium 8 10 1 ST SEGMENT ANALYSIS CHARACTERISTICS The first step in order to make the analysis of the ST segment is to digitize the signal for 10 seconds at a rate of 500 samples per second Eight of the derivations are of direct acquisition I ll and V1 to V6 The remaining four derivations Ill aVR aVL and aVF are derived via Einthoven s law as follows IMI I I avr V0 2 Pm ee 2 avF 1 2 The result of these steps is the digital ECG After the acquisition the program measures the ECG as the second phase of the interpretation process The measurements may be detailed in five steps 1 QRS Detection This step is very important because if it is performed incorrectly the next steps wil
14. listed above are not followed A ATTENTION The CARDIOSTART DEFIBRILLATOR MONITOR features an automatic system for battery charge and it may remain connected to the power grid continuously 11 2 1 DIGITAL STATUS OF THE BATTERY CHARGE On the equipment panel there is a battery indicator as shown below Connected to the power grid ae 39 US DEFIB Y MEICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor besa Battery charging CA J Battery discharged TA 11 2 2 TRANSPORT CONDITIONS 9 9 besa Ambient temperature range from 0 a 50 C Relative humidity range from 10 to 95 Atmospheric pressure range from 700 hPa to 1060 hPa 525mmHg to 795mmHg NOTE US DEFIB does not warrant and shall not be liable for any damage that occurs to the equipment which is transported or stored in another packaging must only and exclusively be transported in its original box 11 3 EQUIPMENT INSTALLATION AND HANDLING RECOMMENDATIONS If the patient is connected to CARDIOSTART DEFIBRILLATOR MONITOR with floating isolation is connected to any other device that cannot have the same type of isolation the patient could touch the conductive parts and cancel the equipment protection effect It features a isolation protection to the patient for connection to any other device that cannot have the same isolation type the patient could touch the conductive parts and cancel the equipment protec
15. of heaviness in the chest weakness fatigue chest pain among others 32 US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Cardiac arrhythmias can be classified in various ways depending on frequency formation mechanism place of origin etc Regarding frequency arrhythmias may be classified as Bradycardia it occurs when the heart beats less than 60 times per minute In some people it can be a normal finding such as athletes Various types of bradycardia are known each one with its own peculiar characteristics Cardiac pacemakers are used in the treatment of this type of arrhythmia There are 3 basic types of bradycardia depending on the location where the electrical system of the heart occurs When blockage occurs in the sinus node the heart s natural pacemaker it is called the sinus node dysfunction In addition the electrical impulse can occur in the atrioventricular node or in the right or left of the electrical system of the heart The important thing is that all of these blockages can lead to a decrease in the number of heartbeat and cause symptoms such as dizziness and fainting Depending on the type of blockage and the symptoms that it is causing there may be a need to deploy an artificial pacemaker Tachycardia it occurs when the heart beats 100 times per minute It usually occurs during physical activity emotional stress in the presence of anemia and other diseases There are several typ
16. on a neonatal patient is done by the fixation of an adhesive tape that cannot be used excessively to avoid lesions to the skin or incorrect readings NOTE The use of oximetric sensors is not recommended during a MRI because the sensors may affect the image or affect the oximetry accuracy 74 US DEFIB TIT MEDICATEGHNOLOSES UC CARDIOSTART Defibrillator Monitor 4 3 1 SENSOR PROLONGED USE Oximetry sensors adult pediatric or universal are not suitable so prolonged use due to the heat emitted by the sensor and the continuous pressure applied to the patient For a longer period of monitoring it is recommended repositioning it to another location in every patient 2 two hours or 4 hours in accordance to the type of sensor 4 3 2 SENSOR CLIP UTILIZATION To place the finger sensor on the patient open the posterior fins of the sensor so that it does not chafe or rub on the finger If the indicator cannot be used for the sensor connection use preferably a small finger do not use the finger sensor on the thumb The sensor should be positioned so that its cable crosses at the top of the hand image below When selecting a location for the sensor choose an extremity limb free from other devices such as arterial catheter blood pressure gauge or intravascular infusion lines Image45 Placing the Oximetry Sensor adult When faults are found in the reading the user must accommodate the patient to correct his posture and t
17. or disables the beep synchronized with the pacemaker pulses D Inhibit pulse Enables or disables the pacemaker pulses deflagration E EMERGENCY Changes the pacemaker configuration to the ones from the Emergency Mode VOO 70 rom 150 mA 40ms 16 1 12 2 PRINTER When the key is pressed for the first time the ECG printing is initiated when it is pressed again the procedure is interrupted 16 1 12 3 NIBP When the key is pressed for the first time the Arterial Pressure scouting is initiated when it is pressed again the procedure is interrupted 16 1 12 4 SYNC ON Enables or disables the electric discharge with the R wave peak When the equipment is turned on the synchronism is off when activated a Sync ON message will appear on the display right below the heart frequency indication and its lead will appear lit The synchronism is performed either by shock paddles as the ECG cable When used simultaneously in the patient ECG cable and shock paddles the Cardiostart Defibrillator Monitor prioritizes the synchronism by the shock paddles An order to defibrillate unsynchronized shock never press the SYNC key because if so the trigger will not occur Only requires defibrillation ventricular fibrillation and ventricular tachycardia and in these cases are not synchronized 16 1 12 5 CANCELS LOAD This key should be activated when the deflagration of the electric discharge is no longer desired in order to dis
18. or regulate the rhythm of the heart Its function is to provide pulses for cardiac stimulation These pulses have two characteristics to be adjusted the number of pulses per minute PPM and current intensity mA It features three possible modes of operation of the pacemaker VOO In this operation mode the system stimulates the patient continuously according to frequency parameters amplitude and width configured in the pacemaker menu VVI In this mode the system only stimulates when it detects a cardiac frequency lower than the configured value on the menu maintaining the stimulus until the patient natural cardiac frequency returns to a value that is equal or greater to that configured to avoid inhibition of abnormal or extra systole T waves The pacemaker has a refractory period of approximately 250ms Emergency Regardless of the chosen mode when the EMERGENCY key is pressed the pacemaker switches to the VOO mode configured in 100 mA 70 ppm and 20 ms NOTE In VOO and VVI modes the pacemaker will be stimulating and transmitting information to the display amplitude width frequency and mode Stimulation current Without connected charge 200 mA Off 0 mA Power supply 12V ECG capture through its adhesive Paddles 26 US DEFIB IW MICANTECHNOLOGIES OC CARDIOSTART Defibrillator Monitor Stimulation output through the adhesive paddles External pacemaker transthoracic non invasive mult
19. to reverse arrhythmias of ventricular fibrillation or ventricular tachycardia with no pulse in adult and pediatric patients as well as cardioversion of arrhythmias which may be required 11 US DEFIB TIT MICATECHNOLOGES VC CARDIOSTART Defibrillator Monitor The Dual Phase defibrillation technology requires less energy than that used by the conventional single phase producing a better performance in patient treatment This equipment can be used in any hospital and rescue units air and ground providing excellent care in advanced life support This equipment includes several functions like patient defibrillation and vital signs monitoring It is possible to visualize on the equipment screen ECG curve Non Invasive Blood Pressure NIBP Invasive Blood Pressure IBP Oxygen Blood Saturation Scouting SPO2 Capnography CO2 external multi programmable Pacemaker to reproduce or regulate the cardiac rhythm The CARDIOSTART DEFIBRILLATOR MONITOR features high resolution colorful liquid crystal display LCD which allows perfect visualization from different angles It also features the optional touch screen display It is possible to record all of the events occurred on the equipment in two ways at the client discretion Through the memory card compact Flash o In order to visualize the data just connect the card to the computer and transfer the data through the AEDRescue software By recording the events in the internal storage
20. with the correct accessories and that it is operated by qualified statf and that all of the precautions listed in the user s manual are followed We accentuate some basic procedures of special care 4 1 ECG MODULE The appropriate gel should be placed on the electrodes as indicated in this manual only at the moment of the use on the patient If the electrode is pre gel do not forget to check the expiry date Use permanent or disposable electrodes of good quality All of these procedures must be followed regardless of the patient Adult or Pediatric Neonatal 4 2 NON INVASIVE BLOOD PRESSURE NIBP MODULE You must use the appropriate cuff for each type of patient Adult teenager pediatric and neonatal and install it properly Certify of the correct equipment configuration so that its use is in accordance with the patient in order to make the pressure to be compatible with it and avoid this way the circulation interruption Only use the cuff supplied by US DEFIB 4 3 OXIMETRY MODULE A sensor composed of LEDs and light sensors is placed on the patient finger adult or pediatric The sensor position must be changed every 4 hours to avoid possible skin burns bruises or lesions to the skin Neonatal and pediatric patients deserve special care using another type of sensor model on Y format its position must be changes every 2 hours to avoid possible skin burn bruises or lesions to the skin This application
21. 0 for CPR and ECC Guidelines Translated from the Portuguese version 2 The new guidelines only encourage CPR with chest compressions RCPSCT for the layman who witness a sudden cardiac arrest RCPSCT is easier to be performed by untrained people and can be easily instructed by phone by an attendant of the Emergency Medical Service EMS 3 The assessment of breathing See hear and feel was removed from the BLS algorithm These steps were shown to be inconsistent as well as time consuming 4 The sequence for recommended for a first responder attendance that acts alone was modified Now the recommendation is to start chest compressions before rescue breath The old sequence AGC airway Good ventilation Chest Compression is now CAG The sequence AGC remains for neonatal care because almost always the cause of CRP in the newborn is asphyxiation 61 US DEFIB TIT MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor 5 There was no change in the recommendation concerning compression ventilation ratio of 30 2 for a single rescuer of adults children and infants babies excluding newborns 6 The greater emphasis of the 2010 Guidelines is the need for a high quality CPR Minimum compression frequency of 100 minute instead of approximately 100 minute as before Compression depth of at least 5 cm in adults Total Return after each chest compression Minimizing interruptions in chest compressions
22. 08 09 10 15 20 25 30 35 40 45 50 Joules e Adult Mode 01 02 03 04 05 06 07 08 09 10 15 20 25 30 35 40 45 50 70 90 100 110 120 150 180 200 240 360 Joules Cardiostart Defibrillator Monitor features intelligent safety system that limits the charge for internal use for pediatric neonatal use 21 US DEFIB TIT MEDICATECHNOLOGES VC CARDIOSTART Defibrillator Monitor Patient thoracic impedance analysis increased defibrillation efficiency and reduced cardiac injuries risk Automatic internal discharge after 30 seconds if there is no trigger or manually through the Erase Charge Key at the user discretion at any time Trigger indicator for the equipment routine tests through flash neon lamp Clock Date Shock Counter It features interchangeable adult pediatric permanent paddles The shock paddles are fixed on the equipment through ima Visual indicator of contact on the PADDLES optional It monitors the contact of the paddles on the patient s chest via barragraph on the display and optionally on the paddles itself via led Performs self test when it is switched on Rechargeable internal battery External reserve batteries with specific charger optional Battery Status Indicator Low charging and charged Capacity to perform up to 150 shocks 200 with full load new battery fully charged Color liquid crystal display which shows the ECG Trace SPO2 NIBP Pacemaker AED Mode Pr
23. 8 73 175 120 80 200 60 40 165 37 Delivered Energy X Charge Energy x Charges Energy in J Charge in Ohms 10J 30 J 50 J 70 J 100 J 120 J 150 J 180 J 200 J NOTE All of the data is subjected to a tolerance of approximately 5 21 MAINTENANCE 21 1 CORRECTIVE AND PREVENTIVE MAINTENANCE 21 1 1 PRECAUTIONS AND SPECIAL CARE 2 Do not place any material on the equipment 67 US DEFIB W MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor Do not reuse disposable materials after its use they should be discarded in appropriate places as special procedures for hospital waste We recommend keeping some auxiliary materials such as surgical scissors disposable razor to remove hair of the chest and disposable gloves if necessary 21 1 2 PREVENTIVE INSPECTIONS AND CLEANING For longer lifespan of CARDIOSTART DEFIBRILLATOR MONITOR and its accessories we recommend that the Inspections and Preventive Cleaning are performed regularly as in the chart below Applied Verification schedule Preventive Inspections Half Yearly Weekly For each process make sure that the equipment is switched off and its electrodes disconnected thus avoiding the risk of shock This process should be performed following the criteria below 21 1 2 1 PREVENTIVE INSPECTIONS We recommend that an inspection is performed every six months in CARDIOSTART DEFIBRILLATOR MONITOR and its acce
24. 8 9 CAPNOGRAPHY MODULE ETCO2 The CO2 produced during the cellular metabolism is transported by the venous system to the atrium and to the right ventricle gets to the loans and diffuses itself from the capillaries to the alveoli From the alveoli this gas is finally eliminated with the exhaled mixture The amount of CO2 that reaches the alveolar spaces is proportional to the cardiac output and to the pulmonary blood flux The elimination of this gas for the environment depends on the ventilation accuracy Thus the measurement of carbon dioxide in exhaled at the end tidal ETCO2 allows continuous monitoring and noninvasive alveolar gas indirectly reflecting its circulating The Capnography is a non invasive measurement which graphical presentation is held according to the patient s respiratory rate rom and involves the measurement of exhaled carbon dioxide to the end of expiration EtCO and the inspired FICO CO2 detection can be performed through two types of sensors Side stream and Mainstream Both sensors have self calibration system that does not require the use of specific gases for periodic calibration 8 9 1 FUNCTIONAL CHARACTERISTICS OF THE CAPNOGRAPHY Side stream and Mainstream type Sensors Exhaled CO2 curve showed continuously on the screen Auto calibration optional procedure that dismisses the specific gases use for periodic calibration Disposable water filter Disposable nasal line Disposable intubated
25. ART Defibrillator Monitor Mean stream Capnography Module Side stream Capnography Module Water Filter Water Trap Fig 45b ss Side Stream System Mean stream System Image38s Placing the CO2 sensor Place the adaptor in position as in the Insert the Plug the figure bellow pipe as ae indicated stream Sensor Front sensor View as in the figure gt Sensor adaptor Image39 Mean Stream Assembling Design 17 8 USING THE IBP INVASIVE BLOOD PRESSURE In case of using two channels of pressure assemble two systems Material 01 disposable dome e 01 syringe e 02 three ways 01 extensor oe oe we First add the two three ways to the domes this increases security and makes the work easier Connect the dome to the pressure transducer To make the connection from dome to transducer the system should be opened for air 58 US DEFIB TIT MEDICANTECHNOLOGES VC CARDIOSTART Defibrillator Monitor All of the system bellow should be filled up with the saline and if possible with heparin Make sure that there are no bubbles especially in the tube that connects to patient Do not use any latex in the circuit The transducer should be placed around the patient midline otherwise the values of pressure will not be accurate The path of the IBP system should be inspected observing the existence of air bubbles in these ways If the air bubbles exist it should be eliminated by allowing t
26. After cleaning and abrasion of the location for example using gauze moistened with alcohol the impedance of skin contact may be reduced from 200KOhms to something around 5KOhms in 90 of the patients Some practices may help minimize the movement artifacts on the ECG 1 Always use electrodes in perfect condition preferentially of Ag AgCl 2 The electrodes of all derivations must be made of the same material to minimize the resultant DC potential and impede the amplifier saturation 3 Clean the skin with alcohol to remove the oil and layer of dead cells 4 Use gel or conductive paste with a Cl basis specific for ECG exams never use other kind of gels for example gel for ultra sound exam 5 Never apply abrasive or conductive paste on the injured skin 6 If it is necessary to remove the hair excess perform the trimming and not the shaving of the area 7 Use the proper adhesive tape micro pore or patch on the back of the electrodes and fix it to the place of contact with the skin making sure that there is a light pressure of the electrode against the skin 8 When the connection is well done when the electrodes are moved you should observe a little momentary artifact with a quick restitution of the trace to normal 9 In long registers the conductor gel tends to dry modifying the interface characteristics in these cases for example registers of verge of bed proceed the periodic replacement of the electrodes on th
27. Avoid excessive ventilation 7 The new guidelines minimize the importance of checking the pulse by trained health professionals The pulse detection can be difficult even for experienced providers especially when blood pressure is very low When executed checking the pulse cannot take more than 10 seconds 8 Previous recommendations to use the Automatic External Defibrillator AED as soon as possible in cases of off hospital witnessed cardiac arrest was reinforced When the CRP is not witnessed EMS staff should start CPR if not already held by the layman while the AED verifies the pace In such cases one may consider 1 to 3 minutes of CPR before the first defibrillation shock 9 It was encouraged to implement programs that establish AED accessible in public places where there is a relatively high probability of CRP witnessed The AHA recommends that such programs are accompanied by planning training and integration with EMS for better effectiveness 10 The post CRP care include optimization of cardiopulmonary function and perfusion of vital organs after the return of spontaneous circulation transport for a proper hospital or ICU which has resources for post CPR care including the ability to intervene in cases of acute coronary syndromes temperature control to improve neurological prognosis and treatment and prevention of multiple organ dysfunction 62 US DEFIB Y MEDICANTEGHNOLOGES VC CARDIOSTART Defibrillator Monitor
28. ES 4 1 ECG MODULE 4 2 NON INVASIVE BLOOD PRESSURE NIBP MODULE 4 3 OXIMETRY MODULE 4 3 1 SENSOR PROLONGED USE 4 3 2 SENSOR CLIP UTILIZATION 4 3 3 Y TYPE SENSOR UTILIZATION 4 4 DEFIBRILLATION MODULE 4 5 INVASIVE BLOOD PRESSURE MODULE IBP 4 6 CAPNOGRAPHY MODULE 5 ADVERSE EFFECTS 6 TECHNICAL SPECIFICATIONS 6 1 PACEMAKER TECHNICAL SPECIFICATIONS 6 2 CAPNOGRAPHY TECHNICAL SPECIFICATIONS ETCO2 6 3 INVASIVE BLOOD PRESSURE TECHNICAL SPECIFICATIONS TBP 6 4 ECG TECHNICAL SPECIFICATIONS CARDIOSTART Defibrillator Monitor 6 5 NON INVASIVE BLOOD PRESSURE TECHNICAL SPECIFICATIONS NIBP 6 6 OXIMETRY TECHNICAL SPECIFICATIONS 7 DISPOSABLE ACCESSORIES MANUFACTURERS 7 1 PERMANENT ACCESSORIES MANUFACTURERS 8 APPENDIX A FUSE REPOSITION 8 1 FUSE REPOSITION PROCEDURE 9 APPENDIX B ECG TRACE INSTABILITY AND NOISES 9 1 THE MOST COMMON ECG INTERFERENCES 9 2 AC POWER SUPPLY INTERFERENCE 9 3 MUSCULAR ARTIFACTS 9 4 BASELINE DISPLACEMENTS 9 5 MOVEMENT ARTIFACTS 10 APPENDIX C MANUFACTURER GUIDELINES AND DECLARATION ELECTROMAGNETIC EMISSIONS 11 TECHNICAL ASSISTANCE PERMANENT TECHNICAL ASSISTANCE 12 CUSTOMERS REGISTERING TEMPLATE 13 VERSION CONTROL 74 74 74 75 75 A 76 IL es 17 77 79 79 SO SO SO 6l Sl 82 82 82 82 83 84 84 85 85 86 90 9 92 US DEFIB Y MICA TECHNOLOGIES VC CARDIOSTART Defibrillator Monitor 1 WARNINGS Fire The CARDIOSTART DEFIBR
29. ILLATOR MONITOR was designed for clinical monitoring applications with guaranteed operation when used correctly in an appropriate medical place and by qualified staff FP eines The operator should proceed to check the equipment conditions and its accessories regular tests as well as its operation before use Z warnine The operator should have knowledge and be aware of all possible collateral effects that can be caused during use of CARDIOSTART DEFIBRILLATOR MONITOR Z warnina CARDIOSTART DEFIBRILLATOR MONITOR Is restricted to one patient at a time and NON FREQUENT USE AN warnina Do not touch the patient the bed stretcher the equipment or any other accessory connected to the patient and or the defibrillator monitor during electrical discharge shock Pv ean When installing the equipment make sure that it is in a place with enough space for ventilation 10cm of upper side 15cm at rear side and 10cm at sides and far from heat radiation AN warnina Equipment and devices connected to CARDIOSTART DEFIBRILLATOR MONITOR different equipment connected to same patient should be connected to the equalization terminals in order to perform equally the potential among them thus preventing damage to them otherwise the system equipment patient grounding may be compromised Pesan There is risk of electric shock if the equipment case is open There are no internal fuses to be replaced by the user All sorts of servic
30. INSTALLING THE RESCUE EAD SOFTWARE 11 EQUIPMENT INSTALLATION 11 1 11 2 11 2 1 11 2 2 11 3 EQUIPMENT UNPACKING AND ADAPTATION POWER SUPPLY BATTERY DIGITAL STATUS OF THE BATTERY CHARGE TRANSPORT CONDITIONS EQUIPMENT INSTALLATION AND HANDLING RECOMMENDATIONS 12 SAFETY AND PROTECTION 13 USING CARDIOSTART DEFIBRILLATOR MONITOR IN STRONG ELECTROMAGNETIC FIELDS 13 1 CARDIOSTART DEFIBRILLATOR MONITOR IN HIGH FREQUENCY ENVIRONMENT 14 CARE WHEN APPLYING DEFIBRILLATION CARDIOVERSION 15 TRIGGERING TEST OF DELIVERED ENERGY 16 OPERATION MODE 16 1 16 1 1 16 1 2 16 1 3 16 1 4 16 1 5 16 1 6 16 1 7 16 1 8 EQUIPMENT CONFIGURATION SETUP SCREEN SYSTEM SCREEN ECG SETUP MENU PACEMAKER SETUP MENU SPO2 SETUP MENU PRINTER SETUP MENU NIBP SETUP MENU DRUGS SETUP MENU 10 10 lI 12 13 14 3 21 23 24 24 25 26 27 27 28 28 29 29 30 30 32 34 36 38 38 39 40 40 4 4 4 42 42 42 42 43 43 44 45 45 46 46 47 US DEFIB Y MEDIATECHNOLOGES VC CARDIOSTART Defibrillator Monitor 16 1 9 IBP SETUP MENU 16 1 10 CAP CAPNOGRAPHY CONFIGURATION MENU 16 1 11 SETUP MENU OF VENTILATION 16 1 12 OTHER FUNCTIONS 16 1 12 1 PACEMAKER 16 1 12 2 PRINTER 16 1 12 3 NIBP 16 1 12 4 SYNC ON 16 1 12 5 CANCELS LOAD 16 1 12 6 FREEZES 16 1 12 BEEP 16 1 12 8 2MIN 16 1 12 9 SELECTION 16 1 12 10 LOAD CHARGE 16 1 12 11 TREATMENT 16 1 12 12 AED MODE 17 ADAPTING CABLES AND ACCES
31. INTERFERENCE The power supply induces a specific frequency interference 50 or 60 Hz which juxtaposes to the ECG sign as shown in picture B2 The main causes of contamination by the AC network may be related as follows Presence of magnetic fields next to the equipment and electrode cables as X ray electrical transmission lines reactors for fluorescent lamps and so on Insufficient connection to the grounding Electrode cable of the patient and supply cable crossing Break or disruption of the electrode cable In this case the interference is of a high amplitude and appears exclusively on the derivation related to the damaged cable Loose or worn out electrode lack of conductor gel or insufficient preparation of the patient skin These conditions increase the impedance of the electrode skin interface and deregulate the sign impedance read by the equipment compromising the rejection effect of common mode of the input amplifiers In these cases the trace normally appears saturated Image B2 ECG with 60 Hz interference on the AC Power Supply 9 3 MUSCULAR ARTIFACTS The muscular activity appears juxtaposed to the ECG as irregular and inconstant waves as the trace exemplified on figure B3 The main causes are listed below Unquiet patient due to cold or discomfort during the exam Specific pathologies for example Parkinson s disease Image B3 ECG contaminated with muscular artifacts muscle tremors
32. LATOR MONITOR US DEFIB lists the procedures to assure security informing the DANGER and RISK according to the Norm NBR IEC 60601 1 4 2003 General Security Prescriptions Collateral Norm Electromedical Programmable Systems reducing the probability of systematic failure risks For better clarifying doubts or request for Technical Assistance please contact US DEFIB US DEFIB MEDICAL TECHNOLOGIES LLC WWW USDEFIB COM INFO USDEFIB COM PHONE 1 305 887 7552 FAX 1 305 887 7541 1 TROUBLESHOOTING The user should always check the equipment conditions This section has the purpose of solving functionality problems of CARDIOSTART DEFIBRILLATOR MONITOR The solutions here suggested involve common procedures that are easy for the User to solve These procedures do not involve the opening of the main cabinet AT ALL of the modules or the permanent accessories lf the procedures here described do not solve the problems the User should collect the equipment and contact the Technical Assistance of US DEFIB Among the items that should be observed are The conditions of the cabinet if it is in one piece or presents any cracks or dirty The battery conditions if it is charged or not Are all the accessories required for the use present adults or pediatric electrodes patient cables oximetry sensor among others Are the accessories in good conditions PROBLEM RECOMMENDED ACTION C ARDIOSTART DEFIBRILLATOR Check
33. NITOR Detects contact of the electrode Analyses automatically the ECG Provides orientation for the operator during the defibrillation therapy It features voice and text command to instruct the rescuer during the CPR sequence The transthoracic impedance of the patient will be measured by the defibrillation electrodes If the impedance of the base line is greater than the maximum limit value the CARDIOSTART DEFIBRILLATOR MONITOR will determine if the electrodes don t have the adequate contact with the patient or haven t been correctly connected to CARDIOSTART DEFIBRILLATOR MONITOR Consequently the ECG analysis and the release of the defibrillation shocks will be interrupted The text message on the display will instruct the user to replace the electrodes at the patient s chest if the electrodes contact is not enough Optionally in the AED Mode for Pediatric use the charge is limited to 50J automatically When the PEDIATRIC PADS are inserted the system automatically limits the energy in proportion of the sequence of 1st 2nd and subsequent shocks respectively 20 1 RECORDING METHODS FOR AED MoDE The possible arrhythmias for VT and VF defibrillation are pre setup in the equipment eliminating the necessity for operator configuration resulting in significant gain in treatment time 20 2 RHYTHM SOURCE FOR AED MobE Through the Defibrillator Analyzer equipment cardiac rhythm
34. OSTART Defibrillator Monitor Field to write the patient s name Field to write the patient s age and weight Date and time Printing Beginning and Ending Time Number of applied shocks NIBP Average Diastolic Systolic Blood saturationSPO2 ECG Amplitude on the Curve Bypass Speed Heart Rate Other data may be deployed if requested by the client PULSE OXIMETRY CHARACTERISTICS Pulse oximetry with plethysmographic curve and saturation indication of numeric oxygen in percentile Amplitude of the plethysmographic wave adjusted on the screen It features complete alarms system and audio and visual indication of the level of SPOs though the pulse signal tone the alarms volumes and the audio pulse indicator are adjusted independently audiovisual adjustable alarms low and high level of SPOzsand cardiac frequency bradycardia and tachycardia non detected pulse alarms disconnected sensor searching for pulse Good response at low perfusion The frequency measured by the equipment is situated approximately between 10 and 300 bpm with a precision of 3 The pulse oximetry is used in situations where the oxygen saturation SPOz is essential in anesthesia during surgeries and in post surgery patients under intensive care treatment in ambulances or even at home It has been proven efficient with a sample range from 70 to 100 with accuracy of 3 The scouted saturation accuracy
35. R MONITOR 7 1 PARTS LIST ACCESSORIES 01 conductive gel tube 100 ml 01 Interchangeable and permanent external electrodes pair Paddles adult child 01 5 way patient cable 50 AG AGCL Disposable electrodes 01 Adult NIBP Cuff only in versions with NIBP 01 Pediatric NIBP Cuff only in versions with NIBP 13 US DEFIB TIT MEICANTECHNOLOGES VC CARDIOSTART Defibrillator Monitor 01 IBP kit only in versions with IBP 01 CO2 kit only in versions with Capnography 01 Adult SpO2 Sensor Clip only in versions with SpO2 01 3 pole power supply cable 01 Grounding equalization cable 01 CD with User manual Software for card reading in versions with Data Card 01 Pair of Adult Pediatric Disposable External Electrodes only in versions with pacemaker and AED Mode 01 Roll of Thermal Printer Paper only in versions with Thermal Printer Warranty Certificate OPTIONAL ACCESSORIES 3 way Patient cable ECG Pediatric oximetry sensor type clip Ear oximetry sensor Adult Pediatric Neonatal type Y oximetry sensor Shock paddles for Internal adult pediatric defibrillation and cardioversion Compact Flash Memory Card Transport Case destined for transport and also safer storage of CARDIOSTART DEFIBRILLATOR MONITOR Connection cable for external battery used in ambulances aircrafts or occasions where electrical energy is not available for long periods of time Cables sensors paddles
36. SORIES Izi ECG MODULE PADDLE CONNECTOR 17 2 SPO2 OXIMETRY SENSOR 17 3 ADAPTING THE NIBP CUFF 17 4 ADAPTING PACEMAKER PADDLES 17 4 1 PACEMAKER USE INSTRUCTION 17 5 ADAPTING CARDIOSTART DEFIBRILLATOR MONITOR PADS 17 6 INSERTING THERMAL PAPER IN THE PRINTER 17 6 1 INSTRUCTIONS TO PLACE THERMAL PAPER IN THE TR 50 OR SP 48 PRINTER 17 7 USING CAPNOGRAPHY AND SENSORS 17 8 USING THE IBP INVASIVE BLOOD PRESSURE 17 8 1 RESETING IBP 18 FOUNDATIONS 18 1 DEFIBRILLATION CONCEPT 18 2 DEFIBRILLATION IMPORTANCE 18 3 THE CARDIOVERSION 19 GUIDELINES 7010 AMERICAN HEART ASSOCIATION 19 1 REFERRALS 20 HEART PACE DETECTOR AED MODE OPTIONAL 20 1 RECORDING METHODS FOR AED MODE 20 2 RHYTHM SOURCE FOR AED MODE 20 3 RHYTHM SELECTION CRITERIA FOR AED MODE 20 4 ANNOTATION METHODS 20 5 DETECTOR PERFORMANCE RESULTS 20 6 APPLIED TECHNOLOGY 21 MAINTENANCE 21 1 CORRECTIVE AND PREVENTIVE MAINTENANCE 21 1 1 PRECAUTIONS AND SPECIAL CARE 21 1 2 PREVENTIVE INSPECTIONS AND CLEANING 21 1 2 1 PREVENTIVE INSPECTIONS 21 1 3 CLEANING 21 1 4 PREVENTIVE MAINTENANCE 22 ADDITIONAL INFORMATION TROUBLESHOOTING 2 CABLES AND ACCESSORIES HANDLING 3 POWER SUPPLY AND GROUNDING 4 PHYSIOLOGICAL EFFECTS m 47 48 48 48 48 49 49 49 49 49 49 49 50 50 50 50 50 50 51l 2 53 53 56 56 s eyi 59 60 60 60 60 6l 63 63 64 64 64 64 65 65 67 67 67 68 68 68 69 70 70 72 73 74 US DEFIB MEDICAL TECHNOLOGI
37. User Manual CardioStart Defibrillator Monitor APEX Pas y o SE D Pus DEFIB F rnasic Z eripritator JMonrror Sel Pa Pacemaker E SAA E N l gt G 18 17 13 A Charge Shock gt ito rinter NIBP Cancel Sync Freeze charge Assync yy US DEFIB MEDICAL TECHNOLOGIES Manufacturer US Defib Medical Technologies Address 7831 NW 72 AVENUE MEDLEY MIAMI Zip Code 33166 Phone 1 305 8877552 1 305 8877541 Legal Representative Amanda Felix OBELIS s a AV DE TERVUEREN 34 BTE 44 BRUSSELS CITY BELGIUM US DEFIB IV MEDICAL TEGHNOLOGES OC CARDIOSTART Defibrillator Monitor FOREWORD Congratulations for acquiring the US DEFIB equipment This product incorporates up to date technology We are sure you will be very satisfied with the CARDIOSTART DEFIBRILLATOR MONITOR READ ALL OF THE OPERATION INSTRUCTIONS BEFORE operating CARDIOSTART DEFIBRILLATOR MONITOR This User Manual contains all of the required information for a full interaction with the equipment from information concerning operation to necessary care for better conservation of CARDIOSTART DEFIBRILLATOR MONITOR This equipment should only be used by a qualified professional to provide advanced life support After you finish reading the entire User Manual keep it in a protected location so you can refer to it at any moment A future reference could be required for new users The pe
38. ata will be presented automatically and it is possible to insert comments The patient information should be filled by the rescuer or professional who operates the software To print the information just click on the print icon on the screen 37 US DEFIB Y MICANTEGHNOLOGES VC CARDIOSTART Defibrillator Monitor AED Rescue fae D ki 2 cos Events Geninfo 00 0005 00 00 06 00 00 07 G0 00 08 00 00 09 00 60 10 000041 000012 000013 000014 Event Saia irene 1000 Image31 AED Software General Information Screen 11 EQUIPMENT INSTALLATION 11 1 EQUIPMENT UNPACKING AND ADAPTATION Remove the equipment from the package Accommodate it on an adequate and easy access location Install it away from other equipment which generates strong magnetic fields like radiological devices air conditioning system and others Ensure that the installation place has an adequate ventilation and is within the pressure and temperature range indicated in this manual item 31 This equipment was designed to operate in environments without flammable anesthetic e cleaning agents Do not operate it in presence of flammable gases in general 11 2 POWER SUPPLY BATTERY CARDIOSTART DEFIBRILLATOR MONITOR features a Lithium Steel or Lithium Polymer both batteries with capacity of up to 150 shocks trigger at 200 J 50 shocks triggers at 360J or up to 38 US DEFIB TIT MICA TECHNOLOGIES VC CARDIOSTART Defibrillato
39. be calculated from the equation that is IEC 61000 4 3 applicable to the transmitter frequency 3 Vrms V1 V 150 kHz to 80 Mhz Compliant Conducted RF 3 V m IEC 61000 4 6 80 Mhz to 2 5 Ghz E1 V m Compliant Recommended Separation Distance d 3 5 V1 VP d 3 5 V1 VP 80 MHz to 800 Mhz 88 US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor d 7 E1 VP 800 MHz to 2 5 GHz where P is the maximum nominal potency of the transmitter output in watts w according to the transmitter manufacturer and d is the recommended separation distance in meters m It is recommended that The field intensity established by the RF transmitter as determined through an electromagnetical inspection on then location is smaller than the conformity level in each frequency range Interference may occur around the equipment marked with the following symbol Co Note 1 n 80 Mhz and 800 MHz it is applied a higher frequency range Note 2 These guidelines may not be applicable in all of the situations The electromagnetic propagation is affected by structures objects and people absorption and reflection 2 The field intensities established by the fixed transmitters such as radio base telephone wireless cell phone and mobile terrestrial radios amateur radio AM and FM radio transmissions and VT transmission may not be theoretically predicted with accuracy To evaluate the electromagnetical environment due
40. ble 1 IMPEDANCE A PHASE 01 B PHASE 02 25 Ohms 30 Ohms 40 Ohms 50 Ohms 60 Ohms The phase B corresponds to 2 3 of phase A Maximum width A B 20 ms Dead time C 0 5 ms 65 US DEFIB TIT MEDICATECHNOLOSES VC CARDIOSTART Defibrillator Monitor Patient Impedance Ohms Image44 Variation of waveform according to patient Impedance Delivered energy Variation and duration of defibrillation phases performed with Truncate Dual Phase Waveform Table 2 Capacitor Charge 1237 Volts 150 Joules Impedance Phase 1 A Phase 2 B A B Ms Ms Ms Delivered A B Energy in Joules 60 40 80 200 60 40 1401 80 200 60 40 1305 80 200 60 40 1207 80 200 60 40 1115 80 200 60 40 1032 Capacitor Charge 1428 Volts 200 Joules Delivered A B Energy in Joules 60 40 80 200 60 40 186 84 80 200 60 40 80 200 60 40 160 92 80 o 80 Impedance Phase 1 A Phase 2 B A B Ms Ms Ms 60 40 148 70 60 40 137 69 66 US DEFIB MEDICAL TECHNOLOGIES CARDIOSTART Defibrillator Monitor Capacitor Charge 1428 Volts 240 Joules Delivered Impedance ilar i A B A te A B Energy in Joules 25 239 96 50 236 00 75 120 80 200 60 40 224 30 100 120 80 200 60 40 208 95 125 120 80 200 60 40 193 40 150 120 80 200 60 40 17
41. ble battery charger with external power supply and isolation between power grid patient and operator c Aircrafts Low radiation level of electromagnetic fields High immunity for external electromagnetic fields and transients High mechanical resistance for vibration 13 USING CARDIOSTART DEFIBRILLATOR MONITOR IN STRONG ELECTROMAGNETIC FIELDS This equipment is designed for providing resistance to electromagnetic interference However its operation may be affected in the presence of strong sources of electromagnetic interference or radio frequency as for example mobile phones radio communicators etc The Defibrillator Monitor s operation can be affected by the presence of sources of electromagnetic energy such as electrosurgical equipment and computer tomography CT 13 1 CARDIOSTART DEFIBRILLATOR MONITOR IN HIGH FREQUENCY ENVIRONMENT An extreme care should be taken during surgeries that use equipment operating with high frequency especially in patients with pacemaker Besides risk of pacemaker damages the electric cauterization currents could provoke fibrillation to the patient Always keep a DEFIBRILLATOR MONITOR nearby 41 US DEFIB IW MDICANTECHNOLOGIES OC CARDIOSTART Defibrillator Monitor Respect the minimum distance of 15 cm between ECG electrodes and the electric scalpel or defibrillator if they are used at same time In case of doubt disconnect the ECG cable This equipment may cause radio
42. charge the capacitor 16 1 12 6 FREEZES This key when activated freezes the curves that are on the display To unfreeze press it again 16 1 12 7 BEEP It inhibits the identification beep of the R wave 16 1 12 8 2MIN It inhibits the sound alarms for 2 minutes 49 US DEFIB IW MICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor 16 1 12 9 SELECTION It allows adjusting the charge level that is going to be used in the next shock 16 1 12 10 LOAD CHARGE It charges the capacitor preparing the equipment for the next trigger If the equipment is not configured for command by the paddles buttons the capacitor will only be charged if this key is pressed 16 1 12 11 TREATMENT When activated it performs the treatment The treatment can also occur when both of the paddle buttons are activated simultaneously NOTE lf the equipment is configured for command through the blade buttons there will be the following functions 1 STERNUM Loads the capacitor 2 APEX Selects the Load The equipment allows you to perform the selection of load level by pressing the APEX key and also charges the capacitor by pressing the STERNUM key and triggers by pressing simultaneously both the keys of the paddles 16 1 12 12 AED MODE When the AED mode is activated the equipment performs the functions of an AED automatically featuring voice and text command with optional volume control to instruct the rescuer during CPR sequence T
43. d Asynchronous Mode 18 Pacemaker Electrodes Entry Connector 19 5 7 Color Display 20 Adult Pediatric Shock Paddles 21 Treatment Button 22 Charge Button 23 Charge Selection Key 24 Transportation Handle 25 Test Born 26 Compact Flash Card Entry 2 Trigger Button 20 US DEFIB EO ECOL CARDIOSTART Defibrillator Monitor rv 4 L U 1 Tripolar Power Connector 2 Fuse Port 3 Cooling Fan 4 RJ 45 Connector 5 Ambulance Connector Cable Image26 CARDIOSTART DEFIBRILLATOR MONITOR Parts Identification Side and Rear View 8 1 CARDIOSTART DEFIBRILLATOR MONITOR CHARACTERISTICS Defibrillation with truncated dual phase exponential waveform with charge of 1 to 200 Joules and optional of 1 to 360 Joules with operation instructions on the panel of CARDIOSTART DEFIBRILLATOR MONITOR Defibrillation Range Scale 200Joules Version e Pediatric Mode 01 02 03 04 05 06 07 08 09 10 15 20 25 30 35 40 45 50 Joules e Adult Mode 01 02 03 04 05 06 07 08 09 10 15 20 25 30 35 40 45 50 70 90 100 110 120 150 180 200 Joules 270Joules Version e Pediatric Mode 01 02 03 04 05 06 07 08 09 10 15 20 25 30 35 40 45 50 Joules e Adult Mode 01 02 03 04 05 06 07 08 09 10 15 20 25 30 35 40 45 50 70 90 100 110 120 150 180 200 270 Joules y 360Joules Version e Pediatric Mode 01 02 03 04 05 06 07
44. d in the mainstream system to check if they are clean sterilized and in perfect condition to avoid a possible bacterial contamination 5 ADVERSE EFFECTS US DEFIB manufacturer of clinical medical equipment requests to users to report possible defects or occurrences of any undesirable event in order to warrant the equipment quality Therefore any flaw or mal function contact the nearest Authorized Technical Support or directly with the sale consultant US DEFIB MEDICAL TECHNOLOGIES LLC www usdefib com info usdefib com Phone 1 305 887 7552 Fax 1 305 887 7541 6 TECHNICAL SPECIFICATIONS NBR IEC 60601 1 1 2004 NBR IEC 60601 1 2 2010 NBR IEC 60601 1 4 2004 NBR IEC60601 2 4 2005 NBR IEC 60601 2 27 1997 NBR IEC 60601 2 30 1997 NBR IEC 60601 2 49 2003 MDD 93 42 EEC 2007 EN ISSO 14971 2007 EN ISO 13485 2003 and other Relevant Certifications Product Certification INMETRO According to harmonized technical standards Type of protection against electrical shock Applicable to each module Protection rating against electrical shock ECG Pacemaker Defibrillation proof CF applied part Defibrillator SPO2 NIBP CO2 AED Mode Invasive 117 US DEFIB TIT MEDICATEGHNOLOGES VS CARDIOSTART Defibrillator Monitor Blood Pressure Defibrillation proof BF applied part IP22 Equipment not suitable to be used in the presence of inflammable air mixture O and N2O Protection against liquids and
45. darone Selects the level of injected Drug Dofetilide Selects the level of injected Drug Sotalol Selects the level of injected Drug Verapanil Selects the level of injected Drug Drug 8 and other used in CPR Drug 9 and other used in CPR 16 1 9 IBP SETUP MENU Exit Blood Pressure Maximum Gain Average Speed Minimum Alarm Patient Calibrate 1 Exit Returns to the previous Menu 2 Maximum Allows adjusting the Alarm range 3 Average Allows adjusting the Alarm range 4 Minimum Allows adjusting the Alarm range 5 Patient Selects patient Adult or Pediatric 6 Blood Pressure When activated we have the following pressure types PVC AD VD PAP PCP AE VE AO PA PIC P1 P2 P3 and P4 7 Gain The available gains are from 0 5N to 2N or other optional 8 Speed Allows varying the scanning speed of the screen to 12 5mm s 25mm s and 50mm s or other optional 9 Alarm Enables YES or disables NO IBP alarm 47 US DEFIB IW MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor 10 Calibrate When activated it calibrates the pressure channel with air measuring subsequently the desired pressure safely 16 1 10 CAP CAPNOGRAPHY CONFIGURATION MENU Exit Curve EtCO2 Gain Response Patient Insp Line Width Apnea Alarm Speed Exit Returns to the previous Menu EtCO2 Allows adjusting the high and low alarm range Respons
46. dule Manufacturer Model ECG Conductive Gel US DEFIB Suprimed Gel In Shape ECG Disposable Electrode US DEFIB Kendall Medi Trace 200 Thermo Sensitive Paper US DEFIB Daru ECG Other o O Pacemaker Paddles set PADs US DEFIB exclusively AED Mode Paddles Set PADs US DEFIB exclusively 81 US DEFIB IW MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor IBP Complete kit Child Nasal Circuit Adult Intubated Line Adult Air Adapter LDS Air Adapter Side Stream Filter Water strap 7 1 PERMANENT ACCESSORIES MANUFACTURERS Accessory Module Manufacturer Model ECG 5 ways patient cable exclusive use US DEFIB exclusively 3 ways patient cable exclusive use US DEFIB exclusively SPO2 Adult Sensor SPO2 Neonatal Sensor SPO2 Y Pediatric Sensor Other o O 3 pole Power cable MAINS CABLE Ambulance cable Neonatal External Paddles Adult Pediatric External Paddles Extension cable for PADs Mainstream CO2 Sensor Invasive Blood Pressure Sensor Blood Pressure Transducer Clamp Support Sergeant NIBP Cuff 8 APPENDIX A FUSE REPOSITION 8 1 FUSE REPOSITION PROCEDURE For the fuse replacement proceed the following steps 1 Check if the equipment is on If it is turn it off by pressing the ON OFF key on the frontal panel 2 Remove the power cable from the plug and from the equipment 3 On the rear panel unscrew and pull out the fuse support remove the damaged fuse replace for a new
47. e Allows adjusting the high and low alarm range Insp Allows adjusting the Alarm range Apnea Allows adjusting the alarm range Speed Allows varying the scanning speed of the screen to 12 5mm s 25mm s and 50mm s Curve Allows varying between full line and just the line Gain The available gains are from 0 5N to 2N Patient Selects patient Adult or Pediatric 10 Line Width The available widths arefrom1 px to 3px 11 Alarm Enables YES or disables NO Capnography alarm OORUN WO CO N 16 1 11 SETUP MENU OF VENTILATION VENTILA O Exit Ventilation Intubation Peripheral AV Central AV 1 Exit Returns to the previous Menu 2 Ventilation Allows you to set the ventilation mode Spontaneous Assisted Controlled 3 Intubation Allows you to set between YES or NO and the method of intubation Oral Nasal and Tracheotomy 4 Peripheral AV Allows you to set between YES or NO 5 Central AV Allows you to set between VJI VSC OUT NO 16 1 12 OTHER FUNCTIONS Besides the accessible items on the Configuration Menu there are other accessible functions on CARDIOSTART DEFIBRILLATOR MONITOR panel 16 1 12 1 PACEMAKER A On Off Enables or disables the Pacemaker function 48 US DEFIB TYNE MICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor B MODE Sync or Async Alternates between the VOO and VVI modes C Inhibits the beep Enables
48. e Width Amplitude Frequency Beep Pulse 1 Exit Returns to previous Menu 2 2 Mode Select Pacemaker operation mode MP of the following modes VOO The PM sends pulses according to configured parameters regardless of any ECG signal detected in patient VVI The PM sends pulses according to configured parameters only if the patient detected signal is outside these parameters range Width Defines the pulse width from 5 to 50 ms Amplitude Defines the pulse amplitude from 5 to 200 ms Frequency Defines the pulse frequency from 10 to 300 ppm pulse per minute Beep Enables yes or disables no pulse beep o pL S 7 Pulse Enables yes or disables no the PM pulse sending 16 1 5 SPO2 SETUP MENU 45 US DEFIB TIT MEDICANTEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Beep Alarm ee oe Exit Returns to previous Menu Max Sat Defines the minimum saturation for alarm operation from 40 to 100 Min Sat Defines the minimum saturation for alarm operation from 40 to 100 Max PPM Defines the pulsation maximum frequency for alarm operation from 30 to 240 ppm Min PPM Defines the pulsation minimum frequency for alarm operation from 30 to 120 ppm Gain Select the SPO2 amplitude for N 2 1N or 2N Beep Enables yes or disables no the pulse beeps Alarm Enables yes or disables no the SPO2 alarm 16 1 6 PRINTER SETUP MENU Exit ee Auto
49. e applied parts ANVARNING If it is necessary to replace any part of equipment except the disposable materials the manufacturer or authorized network should be contacted to supply the material and to perform the substitution ANANING There is risk of environment pollution associated to the use of accessories and consumption materials at the end of its lifespan The accessories and consumption materials should be discarded in hospital waste according to environmental laws The intern batteries should be returned to the manufacturer after substitution due to defect or end of lifespan Fics All of the material replacement should be performed according to specifications included in this manual US DEFIB only guarantees the equipment perfect operation if the orientations are properly observed Ti sie In special cases if necessary US DEFIB will provide with agreement all technical material like circuit diagrams material list technical information components list calibration and benchmarking instructions or whatever is necessary so the qualified technical personnel can perform repairs in the repairable parts determined by the manufacturer The maintenance authorization should be formally expressed by US DEFIB US DEFIB TIE MEICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor 2 SYMBOLS AND ABBREVIATIONS Grounding terminal for protection Dangerous Electric Voltage Attention Check accompanying documents
50. e patient preferentially in a place slightly different from the previous 10 Clean the skin after the exam applying gauze moistened with neutral soap for complete removal of the conductor gel Image B5 ECG with contamination by movement artifacts In A and B the detection of cardiac sign is impossible and in C the amplifier even saturates taking a while to return to the baseline 10 APPENDIX C MANUFACTURER GUIDELINES AND DECLARATION ELECTROMAGNETIC EMISSIONS 86 US DEFIB TIT MEDICATECHNOLOSES VC CARDIOSTART Defibrillator Monitor CARDIOSTART DEFIBRILLATOR MONITOR was designed for operation in any environment presented below The client or user of CARDIOSTART DEFIBRILLATOR MONITOR must assure its operation in one of those environments RF EMISSIONS ELECTROMAGNETIC ENVIRONMENT MEASUREMENT COMPLIANCE ORIENTATION RF emissions CARDIOSTART DEFIBRILLATOR MONITOR uses RF according to Ground energy exclusively for its internal functions So its RF ABNT NBR IEC p emissions are very low and it s not probable that they CISPR 11 cause any interference in electronic equipment nearby RF emissions according to ABNT NBR IEC Class A CISPR 11 CARDIOSTARTDEFIBRILLATOR MONITOR is suitable Harmonic for use in all of the residential environments and those emissions that are directly connected to the public network of IEC 61000 3 2 distribution of low voltage electricity that supplies Emissions due edifications for domes
51. e the equipment precision Line cuff must not be applied on the same limb or extremity of the SPO sensor When the cuff inflates the SPOsmonitoring may be affected AN Do not place the cuff on any limb or extremity where intravenous infusion is being used or any other area where the blood circulation is compromised 8 8 INVASIVE BLOOD PRESSURE MODULE IP The most accurate way of measuring blood pressure it is performed by using the invasive method This method is performed through a catheter inserted into the artery which is connected to a fluid column The pressure measurement is obtained by means of a pressure transducer that performs the reading By this method there are numerical values and curves that correspond to blood pressure measurement 8 8 1 FUNCTIONAL CHARACTERISTICS OF THE IBP The trace is shown continuously on the screen Selection Visualization of the curve blood pressure values PA AO VE AE PVC AD VD PAP PCP PIC Right Left Esf 28 US DEFIB IW MDICANTECHNOLOGIES OC CARDIOSTART Defibrillator Monitor Maximum average and minimum blood pressures shown continuously on the screen mmHg Manual control of gain in several ranges with baseline variation Possibility of curve Superposing Alarm for the maximum and minimum blood pressures Option of continuous recording of the P I C with aid of a thermal printer with special algorithms for alpha beta and C wave visualization
52. emaker On Off Button Location of stimulation electrodes The stimulation electrodes should be positioned in a way that doesn t interfere with a possible defibrillation Normally the non invasive stimulation is performed in Apex Front configuration as well as in the Front Back configuration Nevertheless we recommend the Front Back configuration to ease the defibrillation procedure if necessary After the connection of both units with the interface cable and after switching on the pulse generator you should press the EMERGENCY key to select the most suitable stimulation In this configuration the Front Electrode front negative pole is located on the V3 derivation and the Electrode Back positive pole on the left scapula near the spinal column J Stimulation Electrodes Application The steps to apply the stimulation electrodes pacing pads are indicated next Remove or loosen the patient cloths Clean and dry the skin area with dry cloth Check the expiration date of the stimulation Paddles Attach them separately following the manufacturer instructions that normally consists in removing the protective cover and attaching them separately pressing them only over the adhesive zones 5 If the electrode does not adhere properly discard it and repeat the previous steps with a new pair oe 55 US DEFIB IW MICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor 6 Insert the autoclaving connector indicated in the elec
53. ement of the ACAL DUE PAR PUEE cuff and repeat the operation Wrong cuff Wrong cuff Review the cuff connection Capnography Messages MESSAGE SHOWN ON to begin the measurement end of the calibration Check the flow of the Check the conditions of the tube and entry line Or Check the if necessary replace the filter flow of the outline The measure has It measured for over 90 seconds 60 seconds exceeded 90s for neonatal These last messages appear when there is some dirt or fold on the tube that impedes the air passage Finally reset the capnography Occlusion Hit the reset option 2 CABLES AND ACCESSORIES HANDLING Before using the equipment on the patient the operator should check if it is in normal operation condition Observe regularly the expiry date and package integrity of the transthoracic electrodes Never use accessories consumables that are not supplied by U S DEFIB We are not responsible for the operation of the equipment if not with the use of all original accessories provided by the U S DEFIB 72 US DEFIB IW MICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor Do not buy similar accessories on the market The capnography module could be damaged due to water filter reuse Follow the accessories use instructions supplied by its manufacturer The water filter must be replaced after each patient and or according to the manufacturer use instructions A ATTENTION In ge
54. enerators among them the cardiac activity in electrical current When it is fixed to the patient body through a layer of conductor gel the electrode establishes conditions of chemical balance in this interface generating a double potential layer called half cell potential The input amplifier realizes this potential as a constant tension level and it does not interfere on the ECG measuring However when the electrode is moved the interface balance is momentarily altered so it is necessary to achieve a new condition of balance This transient disturbance produces an artifact of electrical movement Figure B5 which may be of the order of several times the biometrical sign to be measured Still this type of noise is predominantly of a low frequency spectrally juxtaposing to the ECG and making impossible its elimination through simple filtering The correct application of the conductor gel between electrode and patient skin and electrode utilization of Ag AgCl type reduce substantially the movement artifacts generation stabilizing the electrode gel skin interface 85 US DEFIB IW MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor The appropriate preparation of the location of skin contact with the electrode also contributes to obtaining a more defined ECG sign The superficial layer of the skin corner extract is composed of dead epithelial cells besides having a fat pellicle presenting high impedance characteristics
55. erature Operation Humidity Dimensions Weight Atmospheric Operation Pressure Equipment Software Version CARDIOSTART Defibrillator Monitor COo O 100 consecutive shocks respectively As configuration As configuration High Impact with electric and thermal isolation anti flame Rohs Directive lt 240 ms lt 240ms 0 6 1 PACEMAKER TECHNICAL SPECIFICATIONS Pacemaker Modes Protection against defibrillation HF Filter Output pulse current Output pulse frequency Pulse width Power supply Degree of protection against electric shock OV 12V CF Type Applied Part defibrillator proof 6 2 CAPNOGRAPHY TECHNICAL SPECIFICATIONS ETCO2 Parameter Reading Method Parameters Unit COs Concentration reading range Respiratory Frequency Reading Range Stable condition Compensation Protection level against electric shock ALARMS Type Side stream and Mainstream EtCO2 CO2 Inhalation Respiratory frequency 0 to 50 mmHg 0 to 35 RPM Graphic line and numerical values O to 99 mmHg with 3 seconds N Os and Deflurane CF Type Applied Part Manual for maximum and minimum limits of respiratory frequency EtCO2 stable condition and CO2 inhalation Silent alarm Sonorous alarm disabled for 2 minutes Characteristics Disables audio adjust tone and volume alarm delay US DEFIB TIT MEDICANTECHNOLOSES VS CARDIOSTART Defibrillator Monitor Limits CO2 Inhalation 0 to 10 mmHg Respirator
56. erform the shock in the cases of ventricular fibrillation VF or Asystole even when the blades contacts are activated because the applied charge part is waiting the information of the R wave presence that is not identifiable because the ECG is not on or because the R wave does not exist In this situation the operator activates the paddle keys but the equipment does not trigger This can lead the user to think that the equipment has a defect but actually the 76 US DEFIB IW MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor equipment only triggers when there is no sign of the R wave or when the person turns off the synchronism by pressing the synchronism key on the DEFIBRILLATOR MONITOR control panel In an opposite situation if the objective is the cardioversion synchronized discharge with the R wave and the equipment is configured for defibrillation when the buttons of the paddle trigger are pressed the discharge will occur immediately regardless of the R wave presence Consequently in the randomness of the trigger the shock can occur during the vulnerable period and cause ventricular fibrillation 4 5 INVASIVE BLOOD PRESSURE MODULE IBP The reusable transducers cable should be verified to check if they are in perfect condition of use because they are sealed and sterilized to avoid patient contamination 4 6 CAPNOGRAPHY MODULE The adaptors should be verified both in the side stream system an
57. es some extremely serious o Atrium Tachycardia it is a rapid heart rhythm that originates in the atrium o Atrium Flutter it is an arrhythmia caused by electric circuits of low conduction that originates in the atrium and promotes a rapid and regular rhythm of the heart o Nodal reentrant tachycardia NRT it is an extra electrical pathway near the atrioventricular node which causes the electrical impulse to move in a circle and pass through areas that have been previously passed making the heart beat at a frequency way above normal o Tachycardia by an accessory pathway or Wolff Parkinson White Syndrome it is an extra electrical pathway that exists from birth and connects the atriums to the ventricles causing the electrical impulse to reach the ventricle faster o Atrium Fibrillation it is an extra electrical impulses originated in the atriums that trigger rapid irregular and disorganized heartbeats o Extra Ventricular Systole it is an extra electrical impulse originated in the ventricle that promotes beat ahead of time o Ventricular Tachycardia it is an electrical impulse originated in the ventricles that promotes a rapid potentially life threatening pace Generally it is a medical emergency o Ventricular Fibrillation it is a fast disorganized and erratic rhythm which does not produce ventricular contraction that causes sudden death and requires immediate cardiopulmonary resuscitation and defibrillation electrical s
58. es or future equipment upgrades and its US DEFIB TIE MEICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor parts can only be performed by professionals trained and authorized by US DEFIB MEDICAL TECHNOLOGIES LLC Z warnina There is risk of explosion if this equipment is used in presence of flammable agents like anesthetic gases fuels among others AN warnine When the CARDIOSTART DEFIBRILLATOR MONITOR is used simultaneously with an electric scalpel the orientations about equipment operation indicated in this manual in the presence of high frequency devices must be observed ANANING The CARDIOSTART DEFIBRILLATOR MONITOR equipment is destined for connection to a public network And it doesn t suffer any interference or electromagnetic disturbance in its module operation according to the recommendations from NBR IEC 60601 1 2 CISPR 11 Limits and methods of measuring the characteristics of electromagnetic disturbance in radio frequency of industrial scientific and medical equipment ISM AN wannine The CARDIOSTART DEFIBRILLATOR MONITOR equipment is designed for public network connection and it does not suffer any interference or electromagnetical disturbances in its modules operation according to NBR IEC 60601 1 2 CISPR 11 recommendations Electromagnetic disturbance characteristics in industrial scientific and medic equipment radiofrequency measurement limits and methods ISM Z warnina In
59. exit in certain situations the signals captured by ECG are difficult to detect for instance when there is a wide and short R wave When the DEFIBRILLATOR MONITOR is charged in the synchronized mode its discharge only happens if there is R wave and the patient impedance is within the range from 250 to 500 Q and the Pads buttons are simultaneously pressed It is necessary to be careful not to apply the charge in asynchronous mode during the vulnerable period because in this case a ventricular fibrillation VF could be induced 19 GUIDELINES 2010 AMERICAN HEART ASSOCIATION 1 The importance of the Chain of Survival is the Emergency Cardiovascular Care ECC proposed by the American Heart Association AHA has been strengthened in the new guidelines Besides the emphasis on high quality CPR the chain has added another link Care after cardiopulmonary arrest CPA The first link in the chain remains the immediate recognition of the situation of emergency including CRP and the activation of the Emergency Medical Service as image bellow image 1 AHA ECC Adult Survival Chain The links in the new AHA ECC Adult Survival Chain are b immediate recognition of CPR and contacting the emergency service Early CPR oe beens TH en chest 3 Fast defibrillation 4 Effective advanced life support 5 Integrated Post CPR Care al Image41 Reproduced from American Heart Association Highlights of American Heart Association 201
60. f 1 4 and 4N may be setup PATIENT ANALYSIS SYSTEM AED MODE Automatic system of ECG evaluation that detects QRS complexes and automatically identifies malignant arrhythmias ventricular tachycardia and ventricular fibrillation that require defibrillation Synchronism with R wave in case of QRS complex presence when in synchronized mode Pacemaker detector Impedance measurement to adjust phases 1 and 2 of dual phase wave and it does not allow triggering with open or short circuited Paddles It features voice and text command with volume control and to instruct the rescuer during CPR sequence THERMAL PRINTER CHARACTERISTICS High resolution thermal printer with automatic and manual registration of one channel with optional of two channels with the possibility of ECG registration with diagnostic quality with manual or automatic triggering after defibrillation with annotation of date and time heart rate derivation amplitude of the ECG It allows manual records independent of the defibrillation by the paddles This record is made on thermal sensitive paper of 48 mm width x 30 m length for GSI printer 48 mm width x 20 m length or 75 mm width x 20 m length for TR 50 or SP 48 printers Print speed of 12 5 25 50 mm sec or others speeds at the User discretion when requested Data that are printed on thermal paper Field for signature 24 US DEFIB TIT MEDICATEGHNOLOGES VS CARDI
61. f of the electrodes Preparation of the patient skin before fixing the electrodes The excess of skin oil along with the layer of dead epithelial cells that naturally accumulates on the epidermis increases the impedance of the electrode patient interface causing the degradation of the cardiac sign and introducing noises of several sources on the ECG Proceed the preparations on the electrodes fixing location according to the usual clinic practice hair cleaning and shaving if necessary Grounding of the power supply plug where the CARDIOSTART DEFIBRILLATOR MONITOR is installed Follow the recommendations about power supply and grounding described in this manual see item 25 External interference sources proximity generators of radio frequency and power lines if it occurs move them away 10 Equipment filters adjustment 11 For additional support don t hesitate to contact US DEFIB 9 1 THE MOST COMMON ECG INTERFERENCES The ECG sing registered in normal conditions without noise contamination is shown on figure B1 If the ECG acquisition conditions are not appropriate four main types of interference may occur 1 AC Power supply interference 2 Muscular artifacts muscular tremors 3 Baseline displacement drift and 4 Movement artifacts An Ae da hn Deda da An dds 83 US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Image B1 Noiseless Electrocardiogram 9 2 AC POWER SUPPLY
62. fere with the measurement of SPO2 Movements of the patient s foot may misalign the transmitter receiver joint Y sensor and result in inaccuracies in SPO2 The correct placement of the sensor is essential for a good performance of the oximeter Y Sensor Important Features Pediatric Weight of 15 40 Kg Index finger is the ideal applying area with the cable along the back of the hand Such as alternative areas we recommend the thumb or another finger big toe with the cable along to the bottom of the foot For patients who weight over 30Kg another alternative would be the ear lobe outer ear ear flag Move location between 02 to 04 hours Sensor Expiration Undetermined A ATTENTION When positioning the sensors the patient physiological conditions should always be observed Patients with burns that may present greater sensibility to heat and pressure should receive special care such as moving the area in which the sensor was applied more frequently A ATTENTION Do not use the oximeter in continuous monitoring 4 4 DEFIBRILLATION MODULE It is necessary to be careful not to discharge the defibrillator during the vulnerable period because in that case a ventricular fibrillation could be induced A special care should be taken regarding the different use conditions of the equipment Defibrillation or Cardioversion To use the equipment as a defibrillator if the synchronism function is on it will not p
63. follows a trigger sequence of 150J 200J and 200U Charging Time of 3 seconds for 200J and 5 seconds for 360J Pacemaker pulse detection Impedance detection in the 25 Ohm to 500 Ohm range for the triggering Software for drug calculation optional Software for Ventilation Intubation Mode optional ST Segment and Arrhythmia s Analysis Software optional software with impedance and PADDLES contact indicator Optional Charge level selection by the APEX paddle key and charge by pressing the STERNUM paddle key ECG CHARACTERISTICS 3 derivations DI DII DIII for 3 way ECG cable 12 derivations DI DII DIII aVL aVR aVF and V1 to 6 for 5 way ECG cable Capture of ECG signal through defibrillation Paddles adhesive Pacemaker transthoracic Pads through reusable defibrillator Pads and or through ECG patient cable Cardiac frequency reading from 10 to 300 rpm Protection against defibrillation and cardioversion Filter rejects frequency band of 35Hz and 60Hz pass low frequency 120Hz and pass high frequency 0 5HZz QRS detector Pacemaker pulse detector and rejection 23 US DEFIB TYNE MICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor Synchronized beep with QRS Beep indicator on display Cardiac Frequency Indicator on display bpm Pacemaker Indicator on display Speed control for curve tracing 12 5 25 0 or 50 0 mm s ECG channel gain control in 2 1 and 2N optionally gains o
64. he equipment though the strap and connect it to the card input of the computer or if not possible just use an UBS compact flash adapter for download the data in AED rescue software NOTE Compact Flash Memory Card 256MB is provided by CMOS Drake US DEFIB The uses of a different card other than the one provided by the manufacturer will void the warranty of the card reader 10 1 1 INSTALLING THE RESCUE EAD SOFTWARE gt Insert the program CD into the CD DVD ROM gt If the installer does not start automatically locate the file Setup exe on the program CD and double click gt Follow the instructions that appear on the screen gt Once installation is complete click on the software icon which will appear in the start menu of your computer The image below shows the AEDRescue screen 36 US DEFIB siete CARDIOSTART Defibrillator Monitor AED Rescue fe m D kwi xa ECG Events Gen Info 00 00 06 00 00 06 00 00 07 on 00 04 00 On 09 00 00 10 000011 000012 000013 000014 ae ee oe States 17 02012 1000 Image30 AED Software Main Screen In order to visualize the information contained in the memory card just connect it to the computer enter the menu File Import The information will appear on the screen with the ECG curve date and Time of the event In the Event tab all of the occurred events will be presented with date and time In the General Information tab image below All of the equipment d
65. he saline to flow all the way until we can verify that there are no such bubbles in the IBP system 17 8 1 RESETING IBP NOTE Before calibration check the correct assembles of the blood pressure measurement system Select the channel of the blood pressure and close the T2 three way so that the transducer is closed for the patient Open the T1 3 way for the air and hit ZERO After the ZERO O appears the equipment will be able to measure the pressure Just close T1 and open T2 To measure the pressure of the RV right ventricle and LV left ventricle it is necessary that the pressure to be measured corresponds to the type of pressure showed in the equipment because they don t have an average pressure value The tolerance for calibration is within the interval of approximately 100 mm Hg 59 US DEFIB TYNE MICANTECHNOLOGIES OC CARDIOSTART Defibrillator Monitor Serum and deparin Sensor Module Connection Cable IBP Sensor Ji IBP Sensor Image40 IBP Assembling Design 18 FOUNDATIONS 18 1 DEFIBRILLATION CONCEPT The Defibrillation is the emergency procedure that consists in applying a non synchronized electric current to the patient chest external defibrillation or directly on the cardiac muscle internal defibrillation with the objective to revert the Ventricular Fibrillation or Ventricular Tachycardia without pulse It must be differentiated from Cardioversion that consists in an elective or emerge
66. hock 33 US DEFIB MEDICAL TECHNOLOGIES CARDIOSTART Defibrillator Monitor As the place of origin these arrhythmias are classified as oe Atrium as we know the heart consists of four cameras or divisions two atriums and two ventricles The normal stimulus for the heartbeat is generated in the right atrium In some arrhythmias these stimuli are generated in excess or in smaller numbers by the structure that normally generates them in others the stimulus appears elsewhere in the atrium leading to the occurrence of atrium arrhythmias Image27 Atrium Arrhythmia Electrocardiogram Junctional these arrhythmias occur at the junction between the atriums and ventricles Ventricular it arises within the ventricles some with great potential to lead to death et Image28 Ventricular Arrhythmia Electrocardiogram gt 9 IMPEDANCE INDICATOR The instrument provides a visual indicator related to the total transthoracic impedance between the defibrillation paddles The impedance indicator is used to evaluate Proper placing of the shock PADDLES on the patient Quality and integrity of the shock PADDLES Shock PADDLES contact to the patient s skin Proper connection of the shock PADDLES to the equipment It provides a rapid assessment of the patient impedance 34 US DEFIB Y MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Attention The
67. i programmable in modes of Demand Asynchronous fixed and Emergency It is composed by One control unit based on micro controller with serial data transmission and one QRS detection circuit One high voltage source and stimulation pulse generator with amplitude and pulse width enough to successfully perform a non invasive transitory stimulation which requires stimulation rate between 10 and 300 bpm Other frequencies may be optionally configured according to the user choice NOTE The operator can control the stimulation process by means of CARDIOSTART DEFIBRILLATOR MONITOR keyboard The stimulation pulse application can be visualized through a LED panel 8 6 2 STIMULATION SYSTEM SPECIFICATION Stimulation frequency 30 ppm to 200 ppm in steps of 1 ppm Pulse amplitude 0 mA to 200 mA in steps of 1 mA Pulse width O ms to 50 ms in steps of 1 ms Emergency VOO 70 ppm 100 mA 20 ms Protection against defibrillation discharge Up to 400 joules Other specifications may be configured at user discretion A ATTENTION The pacemaker operation in the VOO mode is asynchronous If the patient presents proper cardiac pace the pacemaker may induce ventricular fibrillation if the pacemaker pulse is regularly applied to the ascendant portion of the T wave In case of a bradycardia support it must be assured that the stimulation frequency is higher than the patient s own pace and that the detection is tr
68. ific pathology In these cases the physician should determine whether the given measures and other complementary factors are conclusive or not The EQUIPMENT evaluates all medical criteria taking into account all measurements previously made and determines in his conclusions which criteria are unique and which eliminate others due to their greater diagnostic accuracy These criteria were grouped as follows 31 US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Changes in heart rhythm Changes in the electrical axis Left or right ventricular hypertrophy Intraventricular blockade Left branch blockade Changes in the ST segment Changes in T wave Heart attack Other cases This type of diagnosis must not be considered a substitute in any way for diagnosis by cardiologists This ST Segment analysis should be seen as an efficient tool that assists the physician who specializes in its diagnosis because they are highly efficient in the classification of normality and they have high sensitivity for the detection of pathological cases This assists the physician in reviewing normal cases and it can be used as a guide for the classification of pathological cases When the electrocardiographic signs are ambiguous or highly complex the final diagnosis is left to the physician The final diagnosis must come from the physician A N the ACC AHA recommended the computerized interpretation of ECG
69. inter Capnography and Invasive Blood Pressure IBP optional beep indicator battery status alarms pre and post shock programming parameters indicating the selected energy for trigger PADDLE contact and impedance indicator Event memory via Data Card including curve date and time of approximately 256 MB that corresponds to over 100 hours of continuous recording optional Internal event memory with transference though the USB port including curve date and time with approximately 6hours of continuous recording optional Charge Automatic Adjustment Available in the following language Portuguese English or Spanish It features voice and text command with volume control optional to instruct the rescuer during CPR sequence When in SYNCHRONIZED MODE it performs synchronized triggering with QRS complex with energy delivery time of lt 20ms 22 US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Maximum time for signal stabilization approximately 6 seconds after ideal connection of the cable to the patient It features beep for CPR orientation 100 Comp min in AED MODE Full system of sound and visual alarms with the possibility to setup maximum and minimum values including besides the technical for Loose Electrode and physiological alarms for Asystole Tachycardia Bradycardia and Fibrillation When CARDIOSTAR DEFIBRILLATOR MONITOR is configured in automatic mode the energy charge
70. it is dry disinfect it using gauze moistened with 70 ethyl alcohol 21 1 4 PREVENTIVE MAINTENANCE Corrective and or preventive maintenance of CARDIOSTART DEFIBRILLATOR MONITOR must only be performed by US DEFIB or any representative The frequency of this maintenance is up to the customer in accordance to the table below Maintenance Frequency indication Every 3 months Half yearl Annually Mandatory Every 12 months the equipment must be submitted to an authorized service so that a preventive maintenance is performed This procedure ensures that all the features of the equipment are in full working condition CARDIOSTART DEFIBRILLATOR MONITOR does not require periodic calibration because it is factory calibrated as technical specifications requiring no new calibrations Pulse oximetry parameter is calibrated after the manufacturing process is finalized So there is no need for recalibration of the equipment during its lifespan It was calibrated between 70 and 69 US DEFIB IW Mica TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor 100 and in lower values it is not possible to ensure the accuracy of the calibration In the range of 70 100 for an error of 2 22 ADDITIONAL INFORMATION CARDIOSTART DEFIBRILLATOR MONITOR is programmed with several security systems for failure detection following the adequate hardware and software procedure In order to assure the quality and reliability of CARDIOSTART DEFIBRIL
71. k of R wave Projection of the electric axis in the frontal framing P wave RS complex and T wave vectors The ventricular gradient is also measured The last step is the evaluation of medical reports from the ECG measurements made The ST segment analysis has a number of advantages that must be mentioned Considerable time saving of the cardiology professionals devoted to ECG interpretation in hospitals that offer a large number of these examinations Stability and uniformity in the ECG interpretation and uniformity in interpreting ECG Human fatigue or work pressure can cause specialists not to interpret ECGs maintaining the same needed uniformity The EQUIPMENT always applies the same algorithm and the same rules for ECG interpretation thus providing more stable findings in a timely manner The possibility to store all information relating to a patient allows you to get the same examination report several times without any need to repeat the ECG This information is a valuable component to an ECG database in research applications All medical criteria used in this ST segment analysis fluctuate from a mere recommendation or alerting about the ECG results until a complete diagnosis of a specific change That s why these criteria have varying degrees of specificity and may include phrases such as NOT NECESSARILY PATHOLOGICAL CONSISTENT WITH PROBABLE CONSIDERING when there isn t absolute certainty about the spec
72. l be wrong An auxiliary function is computed for QRS detection based on eight independent derivations The complexes are classified as normal or abnormal in order to achieve a normal QRS standard from derivation to derivation Besides the RR interval is measured and the heartbeat is computed 2 Identification of the T wave end This point is very important because it identifies the end of the cardiac cycle and it is used to measure the QT interval 3 P wave study The program looks for the P waves in all segments T Q the end of the T wave to the beginning of the next QRS complex to determine whether the duration of the PR interval is varying or not 4 Beginnings and endings These points are identified for each wave in order to measure its length and find its peaks 5 Measure For each wave amplitude and duration each interval of derivation is measured Also the deviation of the ST segment such as other parameters is measured The result of the measurement process is the following 30 US DEFIB TIT MEDICATECHNOLOGES VC CARDIOSTART Defibrillator Monitor Duration of QRS complex normal Duration of PR interval Length of the QT interval Heart rate beats per minute Duration of PR interval Length of the P Q R and R waves Amplitude of the P P Q S R and T waves Amplitude at the beginning middle and end of the ST segment Intrinsic deflection time from start of the QRS complex to the pea
73. matic Grid Report Exit Returns to previous Menu Automatic Enables YES or disables NO Automatic Printing when paddle detects ECG Grid Enables YES or disables NO Grid Printing Report Enables YES or disables NO Report Printing 16 1 7 NIBP SETUP MENU Exit So eS ND Patient Mode Automatic Systolic Average Diastolic Start Stop Alarm Exit Returns to the previous Menu Patient Selects patient Adult or Pediatric Mode Selects the measurement mode Manual or Automatic Automatic defines the measurement time interval when automatic mode is selected Systolic Configures the systolic blood pressure for alarm triggering from 30 to 300 mmHg Average Configures the average blood pressure for alarm triggering de 30 a 300 mmHg Diastolic Configures the diastolic blood pressure for alarm triggering de 30 a 300 mmHg 46 US DEFIB TIT MEICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor 8 Start Stop Enables YES or disables NO the NIBP module 9 Alarm Enables YES or disables NO NIBP alarm 16 1 8 DRUGS SETUP MENU Exit Adrenaline Amiodarone Atropine Sodium Bicarb Calci Dofetilide Lidocaine Mexiletine Noradrenalin Potassium Procainamide Sotalol Verapamil Exit Returns to the previous Menu Procainamide Selects the level of injected Drug Lidocaine Selects the level of injected Drug Amio
74. ncy procedure that requires synchronization and that is classically indicated in instable tachycardia cases or depending on medical criteria 18 2 DEFIBRILLATION IMPORTANCE The Early Defibrillation is a link of the Survival Chain It allows a complete myocardium depolarization allowing that the cardiac rhythm regulator centers to recover the control of cardiac electrical activity The defibrillation is the only effective treatment for Ventricular Fibrillation VF the more serious arrhythmia characterized by irregular wave s presence in amplitude and frequency defining the chaotic cardiac rhythm In cases of VF it is necessary to perform the early defibrillation because the chance for well succeed treatment in these cases decreases quickly when time goes by about 7 Seven to 10 ten percent at each minute 18 3 THE CARDIOVERSION 60 US DEFIB TIT MICANTECHNOLOGIES OC CARDIOSTART Defibrillator Monitor The Cardioversion is the other electric therapy modality in order to treat certain cardiac arrhythmia Different from defibrillation the cardioversion is performed by applying a synchronized electric discharge with ventricular depolarization The synchronization is obtained with the detection of QRS complex When you choose the synchronized shock SYNC every time the QRS complex is detected by the DEFIBRILLATOR MONITOR it provides a visual and sound signal Remember that there is a mechanism to inhibit the energy
75. neral CARDIOSTART DEFIBRILLATOR MONITOREQUIPMENT Parts and ACCESSORIES designed to be in contact with biological tissues cells or corporeal fluids are tested and analyzed according to the guidelines and principles of ISO 10993 1 which treats exclusively the bio compatible of applied parts US DEFIB warrants that all permanent and disposable materials in contact with the patient do not cause any damage type or prejudicial physiological effect as long as the described procedures in this manual are followed it is installed in appropriate medical place it is used with correct accessories it is operated by qualified people and that all precautions described in this User Manual are followed The disposable electrodes are Single Use therefore should not be re sterilized Do not use disposable electrodes if its package is damaged There is risk for patient skin burning when applying defibrillation 3 POWER SUPPLY AND GROUNDING When a medical device is connected to the power grid the current leak possibility should be observed from some point of its structure to the patient When that occurs a current may circulate between the equipment and the patient body that is eventually connected to it The human body identifies a 1 mA current on average as a sensibility threshold The currents with a Superior value tend to cause muscle contractions or even burns and ventricular fibrillation Currents bellow 1 mA become imperceptible under the p
76. nous flash will be triggered stating the proper functioning of the charge delivery This procedure can be performed daily as means of preventive maintenance This test is important as it ensures that the selected energy is delivered to the patient when the equipment used in actual operation 16 OPERATION MODE 16 1 EQUIPMENT CONFIGURATION 42 US DEFIB TYEE MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor When you press the navigation button of CARDIOSTART DEFIBRILLATOR MONITOR the Configuration Modules Menu will appear on the display A cursor with an arrow shape gt will appear on the left of the menu items indicating it is the selected one By rotating the navigation button clockwise or counterclockwise the cursor moves to a new menu item according to rotation sense In order to configure the desired module position the cursor on this module and press the navigation key After choosing the module to be configured a new menu will be presented on the display with the configuration items of the selected module Select the item to be configured of the chosen module proceeding the same way as described previously When you select the item observe that it will flash indicating that it is ready to be altered Rotate the navigation key to change the item values increasing or decreasing them After you choose the desired value press the navigation button to keep it altered To exit the menu place the cursor on the item
77. nsthoracic stimulation pulse the Pacemaker of CARDIOSTART DEFIBRILLATOR MONITOR delivers to the patient stimulus that varies from 30 to 200 pulses per minute in asynchronous mode It is possible to program the frequency amplitude and pulse width with the purpose to obtain reliable stimulation with minimum delivered energy to minimize patient disturbance C Applications CARDIOSTART DEFIBRILLATOR MONITOR non invasive Pacemaker is appropriate for pre hospital and hospital ambient In general it is extremely important when urgent cardiac stimulation is required Some indicated transthoracic applications are gt Symptomatic bradycardia treatment during emergency gt During and after cardiac surgery gt To ease the implantation of intravenous stimulator electrode D Stimulator Operation A ATTENTION The described procedure is recommended for support stimulation in bradyasystole patient missing of intrinsic rhythm In case of bradycardia support you should make sure that the stimulation frequency is higher than the patient own rhythm and that the patient QRS capture is reliable There is risk to induce ventricular fibrillation if the stimulation pulse happens during T wave ascending period In order to get reliable QRS capture the operator has to alter the amplitude and pulse width to lower levels targeting 2 Reduction of the energy delivered to the patient prolonging the equipment battery duration Search
78. o exit the AED mode just press the AED key on the equipment panel 17 ADAPTING CABLES AND ACCESSORIES 17 1 ECG MODULE PADDLE CONNECTOR Connect the patient cable to the defibrillator monitor observing the correct position through 5 way patient cable tags Insert the connector until the end so it is firm The other end will be positioned on the patient chest as described below Follow the positions indicated in the drawing below using the color in the correct place for each wire l 50 US DEFIB Y MEICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Image32 Patient Electrodes Positioning There are two color patterns for ECG cables Cardiostart Defibrillator Monitor uses IEC standard View table below EE IEC European AHA American Right Arm RA White L Yellow LA Black Left Leg LL Red Right Leg N Black To clean and disinfect the patient cable use a compress moistened with demineralized water and neutral soap and other compress moistened with isopropyl alcohol respectively Do not use abrasive products because the cable could become dry and brittle Do not store the patient cable twisted because it tends to follow this format and consequently break the internal wires and damage it Just put it on the table with bends corresponding approximately to 1 3 of cable For disposable electrodes after use they should be discarded in appropriate places following to special procedures of h
79. o return the normal blood circulation thus being able to restore the quality of the Signals In the presence of bright light sources such as direct sunlight surgical lamps infrared heating cover the area where the sensor is placed with opaque material With that the possibility of interference from ambient light which could cause erroneous readings will be minimized Avoid applying adhesive tape or adhesive bandage onto reusable the sensor This reduces the risk of venous pulse and saturation wrong measurements and possible damage to the area caused by pressure However the application of an adhesive bandage over the cable can help prevent the sensor to move Sensor Expiration Undetermined 4 3 3 Y TYPE SENSOR UTILIZATION The recommended sensor for pediatric neonatal application is the Y model This sensor is fixed by using an adhesive tape around the foot other areas may not provide acceptable results because of an incorrect infusion or inadequate light Ensure that the fixing tape is secured but not too much avoiding interference in blood flow which may cause inaccurate readings or skin lesions If the sensor is not positioned properly alignment between transmitter and receiver 19 US DEFIB TYNE MEDICAL TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor there may be inaccuracies and instabilities in reading and plethysmographic curve Prevent the radiant light of radiotherapy equipment to exceed the tissue and inter
80. odrigues Felix OBELIS s a EC AV DE TERVUEREN 34 BTE 44 BRUSSELS CITY BELGIUM Mr Final Customer It is with great satisfaction that we deliver the most modern technology in defibrillation and cardioversion 90 US DEFIB TIT MEICANTEGHNOLOSES VC CARDIOSTART Defibrillator Monitor But in order for this equipment to provide the best attendance and utilization we request that the following measures are taken Register your product Why register this registry is necessary to identity the final costumer of the equipment for the cases of preventive and corrective maintenance we will know who and where to contact besides it affirms our commitment regulatory priority assistance to the final user 12 CUSTOMERS REGISTERING TEMPLATE US DEFIB MEDICAL TECHNOLOGIES EQUIPMENT DESCRIPTION SERIAL NUMBER CARDIOSTART DEFIBRILLATOR MONITOR CUSTOMER NAME ADDRESS CITY STATE PHONE NUMBER FAX TECHNICAL SUPPORT ATTENTION Mr Owner Please fill in the blanks above in order to update our databank for questioning and make sure you send us the registration form in order to get a customized service 91 US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor 13 VERSION CONTROL USER MANUAL PROJECT NAME Cardistart Defibrillator Monitor CODENAME ENG CBI300 VERSION CONTROL Rev Date Author Description 92
81. of parameters values which cause less discomfort to the patient in case of unconscious patients E Operation Modes CARDIOSTART DEFIBRILLATOR MONITOR Pacemaker features three operation modes 1 VOO 2 VVI 3 Emergency 54 US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor In the VOO and VVI modes the Pacemaker will be stimulating and transmitting information to the operator through the display Inthe VOO mode the pacemaker stimulates the patient continuously In the VVI mode stimulation will only occur when the patient s natural frequency is lower than the one selected by the operator e e F Modes Selection You can select the operation between Synchronous and Asynchronous mode by pressing the MODE key G Parameter Configuration The parameters are configured in the pacemaker menu Press the Navigator menu to enter main menu rotate the Navigator until the Pacemaker menu and press it again Navigate until the desired parameter press the button again turn to alter and select the Navigator to confirm Check item 15 1 4 H Emergency Regardless of where the Pacemaker operation mode of CARDIOSTART DEFIBRILLATOR MONITOR is running when you press the EMERGENCY key the pacemaker changes to VOO mode and takes on the following parameters 100mA 20ms and 70ppm SWITCHING THE PACEMAKER ON AND OFF In order to turn the pacemaker on or off you should press the Pac
82. of the device o To visualize the data just use the USB port to transfer the data to the AEDRescue software With all these parameters the CARDIOSTART DEFIBRILLATOR MONITOR assists in monitoring the patient and increases the rate of human survival in a cardiac arrest 6 2 CHARACTERISTICS CARDIOSTART DEFIBRILLATOR MONITOR features factory default settings ECG Monitoring and cardiac frequency Dual Phase Defibrillator Monitor Rechargeable Battery In addition to the factory default setting is possible to include the following settings Functional arterial oxygen saturation monitoring SPO2 Non invasive transcutaneous external pacemaker Non invasive pressure monitoring NIBP Capnography CO2 Invasive Blood Pressure IBP Automated external defibrillator monitor mode AED with voice and text commands Thermal Printer Drug software Ventilation intubation Software SZS NOTE Any of the mentioned parameters can be integrated to the Defibrillator Monitor at the discretion of the specific needs of each client and it does not change the intended features of the product 12 US DEFIB TIT MEIATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor 7 OVERVIEW CARDIOSTART DEFIBRILLATOR MONITOR A f Pus DEFIB E rnasic 7 ErerLLaToR Monor Pacemaker EN A E oH ectrodes Image1 CARDIOSTART DEFIBRILLATO
83. oint of view of a shock but they can become lethal generating a cardiac arrest or ventricular fibrillation as long as a current of the order of 10 microamperes circulates in the heart It is extremely important not to let the conductive part of the electrodes transducers connectors and the own patient to contact other conductive parts of the equipment including the ground wire The safe isolation of the patient can only be assured if the cables and electrodes are correctly used by the operator The equipment features a protection grounding terminal located on the rear side of the equipment banana terminal In the lack of power supply CARDIOSTART DEFIBRILLATOR MONITOR starts to operate through its internal battery with approximate duration of 6 hours depending on the battery level When the power supply is normalized the equipment itself will switch to the option of energy supply by the power grid and the battery will recharge automatically 13 US DEFIB Y MEICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Even with the interruption of energy and right after its normalization the equipment will not lose the programmed settings preventing that the user would be required to set them again 4 PHYSIOLOGICAL EFFECTS In general CARDIOSTART DEFIBRILLATOR MONITOR doesn t offer any damage or causes any physiological effects as long as it is installed to operate in an appropriate medical location which it is used
84. one and repeat the opposite operation screwing the support on the rear panel frame 9 APPENDIX B ECG TRACE INSTABILITY AND NOISES 82 US DEFIB TIT MEDICATEGHNOLOSES VC CARDIOSTART Defibrillator Monitor When you notice degradation on the output sign as frequent saturations Sign loss noise presence juxtaposed to the ECG even with the filters activation and wave morphology deformities check carefully the following items 1 Status of the electrodes connection cable Observe if there are cracks or breaks along the cable that must be homogenous in all its extension Integrity of cable extremities and junctions close to the connector to the connection box and the electrodes These points are more susceptible to handling and therefore more susceptible to breaks If you realize a possible damage to the connection cable it should be tested by specialized staff and if necessary replaced Status of the clip and precordial chest type electrodes observing especially the metallic part that stays in contact with the patient skin There should not be any evidence of oxidation or dirt Status of the disposable electrodes that should be of good quality and used just once Type of conductor gel used on electrodes that should be proper to ECG Other gel types as ultra sound gel and or for other aims are not indicated because they can not only introduce noises and the exam unviable but also cause the early wearing of
85. order to prevent fire or shock risks avoid operating or fitting the defibrillator monitor near a water source avoid spilling any liquid product on the case AN warnine The protection against the discharge effects of a cardiac defibrillator is present in the modules inside the equipment The sensors and cables don t have additional protection against the discharge effects of a cardiac defibrillator or when used simultaneously with an equipment that is operating in high frequency TP cpuiies The protection against the effects of a cardiac defibrillator electrical discharge is contained in the modes inside the equipment The sensors and cables do not have additional protection against electrical discharge of the cardiac defibrillator or when used simultaneously with another equipment operated with high frequency US DEFIB TIT MEICATECHNOLOGES VC CARDIOSTART Defibrillator Monitor Z warnine The materials categorized as disposable should not be reused or even submitted to cleaning process and sterilization The disposable materials should be discarded in appropriate places according to special procedures for hospital waste FP cians In general the EQUIPMENT and ACCESSORIES Parts of CARDIOSTART DEFIBRILLATOR MONITOR designed to be in physical contact with biological tissues cells and corporeal fluids are tested according to the guidelines and principles of ISO 10993 1 which deals exclusively with the test of biocompatibility of th
86. ospital waste 17 2 SPO2 OXIMETRY SENSOR Image33 Oximetry sensor positioning Connect the oximetry sensor observing the correct position and the way that the connector is inserted until the end Place the sensor on the patient finger as indicated on the above figure Some care should be taken so that the correct reading is performed Remove enamel and dummy nails because they can block the sensor light blocking the correct reading Do not use adhesive to fix sensor like plaster for instance The sensor is a very fragile device 51 US DEFIB Y MEICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor Avoid dropping or leaving it on floor For reusable sensors after use clean the cable and sensor with a moistened cloth with demineralized water and neutral soap Disinfect with an isopropyl alcohol moistened compress Oximetry sensor Expiration Undetermined 17 3 ADAPTING THE NIBP CUFF A special attention is required not to jeopardize the patient blood circulation when the blood pressure is being measured SCS S SCS S SCS S SCS Do not leave the cuff over the elbow Ulnae nerve path Select a measurement interval that regulates the adequate venous drain during cuff deflection Check periodically the member that supports the cuff to discover Venous Stasis Avoid compression or restriction of pressure pipes this can cause mal function NIBP Cuff Expiration Undetermined
87. prevent scratches on the panel display screen carefully wipe with a dry flannel or in case of dirt a cloth slightly moistened with water and remove the dust or particles of dirt The tags on the equipment are important and for that should not be removed Cleaning and disinfection of the permanent cables should be performed at each equipment use This cleaning is performed with a cloth slightly moistened in demineralized water and neutral liquid soap and another cloth slightly soft and moistened in demineralized water After it is dry disinfect them using gauze moistened with 70 ethyl alcohol For electrodes and disposable accessories after its use they should be discarded in appropriate locations according to special procedures for hospital waste To clean the capnography sensor after its use use a cloth moistened in demineralized water with a small amount of neutral liquid soap and for disinfection use gauze moistened with isopropyl alcohol The tubing water filter Side stream water trap Main stream adaptor sensor and miscellaneous are considered disposable should not be reused and should be discarded in hospital waste according to each hospital procedure Cleaning and disinfection of NIB Cuff should be performed at each equipment use This cleaning is performed with cloth slightly moistened in demineralized water and neutral liquid soap and another cloth slightly soft and moistened in demineralized water After
88. r Monitor 6 hours of monitoring This device has an internal battery charger that performs all of the battery charging control internally with charging time of approximately 6 hours Optionally to increase the shock capacity and monitoring time it is also possible to use external batteries or additional external power supply as follows a The equipment has a connector for power supply in ambulances and aircrafts In occasions when there is no power grid available for long periods of use just connect the equipment to the external power supply thus preserving equipment battery for situations where it is necessary to move the equipment to the location where the patient is Don t use the network cable when the power supply cable for ambulances is being used optional accessory b Easy replacement external batteries reserve with a proper charger a maximum charging period of approximately 4 hours 1 External batteries can be delivered in versions of different charge capacities which vary between 2 hours to 15 hours of monitoring or 50 shocks to 150 consecutive shocks respectively with proper charger FN orcas In case of reserve batteries do not use any charger other than the one supplied by US DEFIB Do not short circuit the battery Charge the battery in a well ventilated environment Do not discharge the battery completely Do not compress or disassemble it Risk of burns fire and explosion if the recommendations
89. rameter Amplitude Frequency and Width If the result is OK it emits a sound signal beep Then the module turns off automatically and the message pacemaker off appears on the display The pulse Pacemaker generator of CARDIOSTART DEFIBRILLATOR MONITOR can be used for non invasive transthoracic stimulation application in a frequency range from 30ppm to 240ppm ATTENTION NON INVASIVE Pacemaker In the VOO mode the pacemaker can induce ventricular fibrillation if the stimulation pulse is applied regularly on the ascending portion of the patient s T wave A CARDIOST ART DEFIBRILLATOR MONITOR Pacemaker General Description The external multi oprogrammable pacemaker offers non invasive stimulation It could be used during cardiac surgeries as cardiac stimulator in emergencies CARDIOSTART DEFIBRILLATOR MONITOR Pacemaker is composed by a control unit based on micro controller with intelligent data transmission capacity to the DEFIBRILLATOR MONITOR 53 US DEFIB IW MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor central CPU and one proper circuit for QRS detection and impedance detection circuit one high voltage power supply and one pulse generator with amplitude frequency and pulse width enough to execute stimulation in both Pacemaker modes by membrane keyboard One LED on the equipment panel identifies in visual form the stimulation pulses B Non invasive Stimulation As this is about non invasive tra
90. rmanent consultation of this manual is a requirement to obtain the equipment best performance correct operation and provide additional safety to the operator as well as to the patient This manual also contains information related to technical support and Warranty Certificate Read carefully the instructions on pages 7 9 of this manual US DEFIB TIT MEICANTEGHNOLOGES VC CARDIOSTART Defibrillator Monitor SUMMARY 3 MEASUREMENT UNITS 4 ACRONYMS USED IN THIS USER MANUAL 5 THROWING AWAY THE EQUIPMENT 6 1 PRESENTATION 6 2 CHARACTERISTICS 7 OVERVIEW 7 1 PARTS LIST ACCESSORIES 7 2 OPTIONAL ACCESSORIES 7 3 ACCESSORIES PHOTO 8 PARTS AND COMMANDS IDENTIFICATION OF CARDIOSTART DEFIBRILLATOR MONITOR 8 1 CARDIOSTART DEFIBRILLATOR MONITOR CHARACTERISTICS 8 2 ECG CHARACTERISTICS 8 3 PATIENT ANALYSIS SYSTEM AED MODE 8 4 THERMAL PRINTER CHARACTERISTICS 8 5 PULSE OXIMETRY CHARACTERISTICS 8 6 PACEMAKER TECHNICAL SPECIFICATION AND CHARACTERISTICS 8 6 1 8 6 2 PACEMAKER CHARACTERISTICS STIMULATION SYSTEM SPECIFICATION 8 7 NON INVASIVE BLOOD PRESSURE NIBP 8 8 INVASIVE BLOOD PRESSURE MODULE IP 6 8 1 FUNCTIONAL CHARACTERISTICS OF THE IBP 8 9 CAPNOGRAPHY MODULE ETCO2 8 9 1 8 10 8 10 1 8 11 FUNCTIONAL CHARACTERISTICS OF THE CAPNOGRAPHY ST SEGMENT ANAL YSIS ST SEGMENT ANALYSIS CHARACTERISTICS CARDIAC ARRHYTHMIAS ANALYSIS 9 IMPEDANCE INDICATOR 10 COMPACT FLASH CARD SLOT OPTIONAL 10 1 1
91. s subject to defibrillation are simulated such as VT and VF the natural rhythms in several widths and frequencies 20 3 RHYTHM SELECTION CRITERIA FOR AED MoDE The selected rhythms are the well known classic indication for defibrillation such as Ventricular Fibrillation and Ventricular Tachycardia 20 4 ANNOTATION METHODS The CARDIOSTART DEFIBRILLATOR MONITOR is equipped with an electroluminescent liquid crystal display where the emergency attending procedures and ECG tracing are plotted and allowing cardiac rhythms graph registration 64 US DEFIB TIT MEDICANTECHNOLOGES VC CARDIOSTART Defibrillator Monitor 20 5 DETECTOR PERFORMANCE RESULTS Rhythm Classification Ventricular tachycardia A A B Ventricular fibrillation A A B True Positive A Rhythm correct classification possible to be defibrillated True Negative B Organized or in perfusion or asystole rhythm that was classified incorrectly as a possible rhythm to be defibrillated False Positive C It is a VT or VF associated with cardiac arrest that was classified incorrectly as not possible to be defibrillated False Negative D Correct classification of all rhythms in which a shock is not indicated 20 6 APPLIED TECHNOLOGY Truncate Exponential Dual Phase Waveform vV 240 50 Ohms FASE 01 FASE 02 1550 0 10 17 20 m3 Image43 Truncate Dual Phase Waveform Variation according to Patient Thoracic Impedance Ta
92. s to physicians Several studies have examined the accuracy of computerized ECG interpretation programs and suggested that computer analysis cannot replace the physician s ECGs interpretation A systematic study of the computerized ECG interpretation performed in 1991 showed that computer programs were on average 6 6 less accurate than the cardiologist in identifying ventricular hypertrophy myocardial infarction MI Rhythm disorders were not assessed in that investigation and informal experience suggests that computer interpretation has a higher error rate in the analysis of the rhythm than in the diagnosis of MI and hypertrophy A Japanese study reported that the latest false positive rate and false negative was 18 times higher for computer interpretation than trainee doctors in more important ECG diagnosis However ECGs computerized interpretation may be useful in the accurate calculation heartbeat conductive intervals and axis as long as there is manual review Thus despite computerized ECG interpretations that may have useful auxiliary value and cannot replace the interpretation of experienced electrocardiograms professionals and should not be used to make clinical decisions 8 11 CARDIAC ARRHYTHMIAS ANALYSIS The arrhythmia s symptoms are quite variable and they may be silent and can be diagnosed by a physician during a cardiologic The most common symptom is palpitation fainting dizziness shortness of breath discomfort feeling
93. sive Blood Pressure Communication Cable Optional 17 US DEFIB TYE MEDICAL TECHNOLOGIES VC CARDIOSTART Defibrillator Monitor A Te e ai ai e i aR ee Image18 Invasive Pressure Transducer Support Image19 NIB Cuff Optional in Neonatal Pediatric Adult and obese sizes permanent use accessory NOT AVAILABLE Image21 Tripolar Power Cable permanent use accessory Image20 Transportation Bag optional Exclusive he h ae Image22 Thermal sensitive paper disposable Image23 External Battery Interconnection Cable optional permanent use accessory optional 18 US DEFIB IV MEDICA TEGHNOLOGES CARDIOSTART Defibrillator Monitor Image24 Compact Flash 256MB Memory Card Optional accessory 8 PARTS AND COMMANDS IDENTIFICATION OF CARDIOSTART DEFIBRILLATOR MONITOR Me OMY OG US DEFIB MEDICAL TECHNOLOGIES CARDIOSTART Defibrillator Monitor Image25 CARDIOSTART DEFIBRILLATOR MONITOR Command Identification 1 On Off 2 Battery Status Indicator 3 AED Mode Electrode Entry Connector 4 AED Mode On Off 5 Disables Alarm for 2 minutes 6 Freeze screen 7 Enable Disable Synchronism 8 Charge Erase 9 NIBP Trigger 10 Print 11 Exit Menu 12 Pacemaker Emergency Mode 13 Pacemaker On Off switch 14 Navigation Button 15 Pacemaker Pulse On Off 16 Disables Pacemaker Beep 17 Select between Synchronous an
94. solids Utilization protection rating in the presence of anesthetic flammable mixture Continuous operation with intermittent charge Operation mode Minimum interval between shocks 30 seconds Printing format 1 channel Automatic and Manual Input impedance lt 10 MQ Impedance detection range 25Q 500 Frequency response w filter 0 5 35 Hz kala i w o filter 0 5 100 Hz AC 60 50 Hz Muscular 35 Hz 5 10 20 mm mV 12 5mm s 25 mm s 50mm s Thermal Printer of High Resolution Thermal Paper Paper Dimensions 48 mm width x 30 m length or 75 mm width x 20 m length LCD 5 7 inches of visible area Colored with contrast adjustment in several sizes and resolutions 5 5to 7 2 inches 100 240 VAC Automatic 50 60 Hz peMenng External DC 10 to 16 VDC Battery 10A Typo Rechargeable Lithium Steel LiFe 14VDC 2300mAh Battery full charging time completely discharged 6 hours Temperature 10 C a 60 C Internal DC Power Supply internal battery Typo optional Rechargeable Lithium Polymer LI PO 11 1 VDC 2200mAh Battery full charging time completely discharged 4hours Temperature 10 C a 60 C 78 US DEFIB MEDICAL TECHNOLOGIES DC External Power Supply reserve AC Current Pads output voltage Pads output current at 50 ohms Maximum charging time Defibrillation Scale Cabinet Discharge time Discharge time with synchronism Operation Temp
95. ssories whether the equipment was used or not following the instructions below Check the validity expiry date of the disposable shock paddles and the accessories functional status If some of these accessories are near expiration or already expired or in bad conditions of use we ask you to purchase a new material only through the manufacturer US DEFIB or any authorized representative Check the maintenance of equipment and its accessories if there is any irregularity in the equipment it needs to be sent to the manufacturer for maintenance and in the case of the accessories you should buy new material only through the manufacturer Perform the triggering test at the terminals of the equipment following the instructions already described in the manual if there is any irregularity send it to the manufacturer or any authorized service center item 15 21 1 3 CLEANING We recommend a cleaning to be performed every three months in CARDIOSTART DEFIBRILLATOR MONITOR and its accessories following the instructions below Cleaning and disinfection of the cabinet should be performed with a cloth slightly moistened with demineralized water and neutral liquid soap and another a cloth slightly moistened with demineralized water with 2 of hypochlorite Do not use cleaning agents 68 US DEFIB TIT MEDICATEGHNOLOSES OC CARDIOSTART Defibrillator Monitor with abrasive organic solvents chlorine alcohol or hydrocarbon solvents To
96. t supplied in a typical commercial environment or vo itage drops enol 60 of voltage drop hospital lf the user of the interruptions and ocianon on ihe in Ut for 5 cycles CARDIOSTART supplied voltage Compliant DEFIBRILLATOR MONITOR according to IEC 70 Ut requires continuous operation 61000 4 11 even when there are 30 of voltage drop interruptions on the electricity in Ut for 25 cycles supply the CARDIOST ART DEFIBRILLATOR MONITOR lt 5 Ut should receive energy without interruptions or with a battery gt 95 of voltage drop 3 Ut for 5 seconds 3 A m Magnetic fields in the supply Magnetic field in the frequency must be in levels supplied frequency that are characteristic of a 50 60 Hz according Compani typical location on a hospital to IEC 61000 4 8 environment or commercial typical Note Ut is the AC supply voltage before applying the essay level CARDIOSTART DEFIBRILLATOR MONITOR was designed for operation in any environment presented below The client or user of CARDIOSTART DEFIBRILLATOR MONITOR must assure its operation in one of those environments Interference resistance test Essay level of ABNT Compliance ELECTROMAGNETIC o NBR IEC 60601 Level ENVIRONMENT ORIENTATION Portable and mobile RF communication equipment should only be used next to any part of CARDIOSTART DEFIBRILLATOR MONITOR including cables with a separation distance smaller than the recommended This safe distance will Radiated RF
97. ter information check Appendix B lf the recommended actions are not enough to correct the problem contact the Authorized Technical Assistance by US DEFIB AN Only remove or replace the fuse while the equipment is turned off Errors Code in the NIBP Module When the equipment detects some error related to the NIBP module it will show a message on the display that should be observed It can be one of the following MESSAGE SHOWN ON THE DISPLAY ERROR DESCRIPTION RECOMMENDED ACTION The module inflated for over 30 seconds Do not repeat the action check the connection tube and cuff Insufficient pressure The pressure is not high enough to produce Check the placement of the result cuff lt 10mmHg or Wrist pressure is smaller than 10mmHg adult Check the placement of the gt 250mmHg mode cuff 05mmHg or gt 150mmHg Wrist pressure is smaller than 5mmHg Check the placement of the Neonatal mode cuff 71 US DEFIB TIT MEICANTECHNOLOGES VC CARDIOSTART Defibrillator Monitor Movement excess Movement excess Try to calm the patient down Irregular measure Irregular measure Check waveform Pulse without rhythm PRS PUIG MER MENEN COU Henle Check the cuff placement performed Only if the patient is adult repeat the measurement do not measure again if neonatal Check the device 100 neutral pulses Over 100 pulses without any result Keep the patient in High blood pressure High blood pressure Check the replac
98. the tripolar supply cable making sure that it is correctly MONITOR does not turn on connected to the electricity Power supply cable is in perfect Check the security fuse located at the rear side After US DEFIB TIT MEDICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor conditions but the equipment still disconnecting the equipment from the electricity open the fuse does not turn on case and remove the fuse that is inside Observe if the internal wire of the fuse is broken If it is replace the component for another of the same model If you can t observe this wire place a new fuse in order to eliminate this possibility fuse model for replacement F 5A 20AG gt See Appendix A The main causes of the trace instability are bad sensor and electrodes connection in the patient and the lack of grounding Therefore if that occurs check if the connections on the patients are perfect and if the equipment is correctly grounded Check for leak in the NIBP cuff and the status of the cables and connectors of the other sensors The majority of the cases of signal instability and excess of noises in the ECG trace is caused by the following factors gt Use of damaged or inappropriate electrodes gt Inappropriate fixation of the electrodes in the patients gt Insufficient grounding of the equipment gt Absence of conducior gel Instability of Parameter Curves Instability and Noises in the ECG Trace NOTE For bet
99. tic use to Scintillation Compliant Tension Float IEC 61000 3 3 RF emissions according to Conlin ABNT NBR IEC p CISPR 14 CARDIOSTARTDEFIBRILLATOR MONITOR is suitable RF emissions for interconnection with other equipment according to Compliant ABNT NBR IEC p CISPR 15 CARDIOSTART DEFIBRILLATOR MONITOR was designed for operation in any environment presented below The client or user of CARDIOSTART DEFIBRILLATOR MONITOR must assure its operation in one of those environments Interference Essay level of ABNT Compliance ELEU TOOTA NEUE istance test NBR IEC 60601 Level ENVIRONMENT resistance tes eve OE ATO 6kV per contact The floors must be made of Static Electricity 8kV by air wood or cement and should Discharge SED have ceramic tiles If the floor according to IEC is made of synthetic material 61000 4 2 the relative humidity must be of at least 30 Compliant Fast transient 2kV in the supply electric disturbances lines triggers according 1kV in the input it Painan to IEC 61000 4 4 output lines ease Rael st Over voltages 1kV differential mode Go aan a environment or according to IEC 2kV common mode p pitat Electricity supply quality Compliant should correspond to the US DEFIB W MEICANTEGHNOLOGES VS CARDIOSTART Defibrillator Monitor J a A lt 5 Ut gt 95 of voltage drop The quality of the supplied in Ut for 0 5 cycle voltage quality should correspond to the voltage 40 U
100. tion effect The interconnection of CARDIOSTART DEFIBRILLATOR MONITOR with any other equipment is only allowed when it is not harmful to the patient to the operator and for the environment If the additional equipment specifications do not inform about interconnection effects contact the manufacturer or an expert The CARDIOSTART DEFIBRILLATOR MONITOR should only be operated by dully qualified personnel Don t shock the patient with short circuited Paddles For the normal activities operation with all of the possible parameters the external shock paddles adult pediatric module should remain connected to the equipment 40 US DEFIB Y MEICATEGHNOLOGES VC CARDIOSTART Defibrillator Monitor 12 SAFETY AND PROTECTION a Patient The shock capacitor is charged just before the trigger and the charge voltage is transferred to the electrodes only at moment of the shock moment in which the physician presses the trigger button The trigger command is only enabled when the capacitor is charged with the selected voltage If the trigger is not performed within 30 seconds after the capacitor charge the equipment cancels the charge automatically through the internal discharge circuit With the pacing module on and the paddles connected to the patient the function of defibrillation of the equipment is automatically disabled b Operator Internal battery to isolate the equipment from external power grid Internal managea
101. to RF fixed transmitters it is recommended an electromagnetical inspection on the location If the field intensity measure on the location that the CARDIOSTART DEFIBRILLATOR MONITOR is used exceeds the conformity level used above the CARDIOSTART DEFIBRILLATOR MONITOR should be observed to check if the operation is normal If an abnormal performance is observed additional procedures may be necessary such as reorientation or replacement of the CARDIOSTART DEFIBRILLATOR MONITOR P Above the frequency range of 150 KHz to 80 MHz the field intensity should be smaller than V1 V m 89 US DEFIB TYNE MICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor 11 TECHNICAL ASSISTANCE US DEFIB MEDICAL TECHNOLOGIES Permanent Technical Assistance Mr Owner US DEFIB has available a large list of representative and technical support all around the Brazilian territory In order to be able to offer a personalized service we request you to send a registering form It aims to update our databank to better addressing authorized technical support service for each region training and others For complaints doubts suggestions and technical support contact with our CAC Customer Assistance Service below US DEFIB MEDICAL TECHNOLOGIES Manufacturer US Defib Medical Techonlogies Address 7831 NW 72 AVENUE MEDLEY MIAMI peat Zip Code 33166 Phone 1 305 8877552 1 305 8877541 Legal Representative Amanda Coelho R
102. trodes cable end to the correspondent extension cable connector of CARDIOSTART DEFIBRILLATOR MONITOR 7 In case of doubt always follow the instructions indicated by the stimulation electrodes manufacturer 17 5 ADAPTING CARDIOSTART DEFIBRILLATOR MONITOR PADS 1 Ensure that the paddles are connected to the Cardiostart Defibrillator Monitor If not plug the cable into the paddles located below the carrying handle of the equipment 2 Place conductive gel electrodes on the paddles 3 Place paddles as image bellow At the trigger moment the Pads must have conductive gel on them and be firmly positioned as image and the Pads trigger keys pushed simultaneously Image36 Positioning of shock Paddles at trigger moment For shocking the operator should press the Select Charge and Load simultaneously to release the electric discharge to the patient Cardiostart Defibrillator Monitor automatically identifies the operation in pediatric mode and limits the energy to 50 Joules Important Observations v Never shock with short circuited paddles 17 6 INSERTING THERMAL PAPER IN THE PRINTER Use appropriate thermal sensitive paper that is easily found in shops for clinical medical and surgical equipment or directly with US DEFIB US DEFIB Thus it warrants equipment clear printing You should observe that the thermal paper has presents a great variation concerning sensibility and abrasion therefore it is possible to observe
103. ustable In the VVI mode the fixation region of the pacemaker electrodes must be verified once that it is external and presents negative voltage the stimulation may produce polarizations that change the common mode voltage compromising the normal detection of the heartbeat This equipment must only be operated by qualified technical staff 8 7 NON INVASIVE BLOOD PRESSURE NIBP 2 US DEFIB IW MEDICA TECHNOLOGIES OC CARDIOSTART Defibrillator Monitor The parameter of noninvasive pressure uses the oscillometric method for the calculation of non invasive blood pressure and provides systolic mean and diastolic blood pressure A cuff is used for transmitting changes in blood pressure caused by blood flow The Non Invasive Blood Pressure module NIBP is protected against discharges of a cardiac defibrillator and does not need specific precaution concerning the equipment In NIBP utilization with cuff which has no metallic wires and does not cause any interference when used together with other High frequency equipment It may be used in adult pediatric child and neonatal patients Manual and automatic operation mode Measurements of systolic diastolic and average arterial pressure Configurable interval to inflate the cuff Automatic zero before each measurement Alarm of minimum average and maximum pressure Resolution 1mmHg Z ony use cuffs supplied by US DEFIB or US DEFIB Other brands may compromis
104. y frequency 0 to 35 RPM EtCO2 0 to 50 mmHg 6 3 INVASIVE BLOOD PRESSURE TECHNICAL SPECIFICATIONS IBP Reading range Tolerance Frequency response Isolation Zero adjustment Transformation standard Digital pressure display Protection level against electric shock Limit values ALARMS Silent alarm Delay 6 4 ECG TECHNICAL SPECIFICATIONS Input impedance Diagnosis 0 05 to 100 Hz Muscular Low pass 35 Hz Beating reading range Tolerance nput Output Offset potential Current leak Defibrillation protection Baseline recovery Systolic indicator QRS Calibration sign Protection level against electric shocks CF type applied part defibrillation proof Limits Adjust Silent alarm Delay 6 5 NONINVASIVE BLOOD PRESSURE TECHNICAL SPECIFICATIONS NIBP Gains 5 10 20 mm Vm 80 US DEFIB TIT MEICANTEGHNOLOSES UC CARDIOSTART Defibrillator Monitor Reading Technique Oscillometric Operation mode Time programming Protection level against electric shock Adult Systolic Adult Diastolic Adult Average Neonatal Systolic Neonatal Diastolic Neonatal Average Adult Neonatal Resolution 6 6 OXIMETRY TECHNICAL SPECIFICATIONS Tolerance 70 to 100 2 digits finger clip 70 to 100 4 digits ear clip 70 to 95 3 digits neonatal Under 70 undefined for all sensors Protection level against electric shock Type Limits Silent Alarm Delay 7 DISPOSABLE ACCESSORIES MANUFACTURERS Accessory Mo

CardioStart Defibrillator Monitor

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