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User Manual Defibrillator MonitorE-HEART

1. The US DEFIB MEDICAL TECHNOLOGIES assures Legal Warranty against any manufacturing defect applicable to the following conditions 1 The valid warranty period lasts 12 twelve months from the emission of the sales receipt related to the purchase date of the equipment by the customer with obligatory model identification serial number and equipment characteristics 2 US DEFIB does not grant any warranty for equipment that is not accompanied by the customer sales receipt 2 1 Prescribed conditions of this warranty Any defect found during installation and or product use the customer should contact US DEFIB MEDICAL immediately that will contact the authorized representatives listed on this manual They on the other hand can only perform any intervention with FORMAL AUTHORIZATION following the validity terms of this authorization The manufacturer is responsible for the replacement of parts and products that present abnormalities proved to be manufacturing defects besides the involved labor in this process Sensors cables in general and accessories required for the correct product operation are warranted against manufacturing defects by a legal term of 90 ninety days from the product purchase date indicated in the customer sales receipt 2 2 The warranty will be cancelled when 1 The equipment s serial number is removed or changed in any way 2 The equipment was installed or used in a way different than t
2. A SY LA a D SS AD x AA SN A amp Sa SS i SS AAS A SJ A AA ES 23 In places where there isn t a US DEFIB authorized technical support the expenses of device transport or M authorized technician displacement to the place where the equipment is it will be charged at the service petitioner A I Customer A y 7 Serial N y B A a SL SIL Seo US DEFIB sis cis aah Defibrillator Monitor E HEART 33 VERSION CONTROL USER MANUAL PROJECT NAME E HEART BIPHASICO DEFIBRILLATOR MONITOR CODENOME ENG CBI400 VERSION CONTROL Ver Date Author _ Description Nov 06 2011 Luara Delfin 24
3. 18 Foundations 18 1 Defibrillation Concept 18 1 1 Defibrillation Importance 18 2 The Cardioversion 18 3 External Transthoracic Cardioversion Defibrillation Indirect on adults 19 E HEART Biphasic Defibrillator Monitor Classification 19 1 General Classification 19 2 Detector of Cardiac Rhythm AED Mode Optional 19 2 1 Recording Methods for AED Mode 19 2 2 Rhythm source for AED Mode 19 2 3 Rhythm Selection Criteria for AED Mode 20 Note Methods 20 1 Detector performance results 21 Applied Technology 21 1 Comparative Monophasic X Biphasic 21 2 Truncated Exponential Dual Phase Waveform 21 3 Variation according to Patient Thoracic Impedance _ UV MEDICAL TECHNOLOGIES Defibrillator Monitor E HEART ae 15 15 15 15 15 16 16 16 16 16 7 __ 18 20 21 24 23 235 14 14 16 16 __16 16 17 17 18 __ 18 18 19 19 19 19 19 20 20 14 14 21 4 Variation of delivered energy and duration of defibrillation phases performed with Truncate Dual Phase Waveform 21 5 Delivered Energy X Charge 22 Maintenance 22 1 Corrective and Preventive Maintenance 22 1 1 Precautions and Special Care 22 1 1 1 Preventive Inspections and Cleaning 22 1 2 Preventive Inspections 22 1 3 Cleaning 22 1 4 Preventive maintenance 23 Additional information 24 Troubleshooting 25 Precautions and Special Care 25 1 Equipment and Accessories Cleaning and Disinfection 25 2 Storage and Transport 25 3 Cables and Acces
4. Allows adjusting the high and low alarm range Resp Allows adjusting the high and low alarm range Insp Allows adjusting the alarm range Apnea Allows adjusting the alarm range Speed Allows to vary the scanning speed of the screen to 12 5 mm s 25 mm s and 50 mm s Curve Allows varying between full line or just the line Gain The available gains are from 0 5N to 2N Patient Select patient adult or child 10 Line width the available widths are 1px to 3px 11 Alarm Enables YES or disables NO the Capnography alarm oe aN O CO N 16 1 11 VENTILATION SETUP MENU VENTILATION gt 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 tracheostomy 4 Peripheral AV Allows you to set between YES or NO 5 Central AV Allows you to set between IJV VSC OUT NO 14 US DEFIB i stint Defibrillator Monitor E HEART 16 1 12 OTHER FUNCTIONS Besides the accessible items on the Configuration Menu there are other accessible functions on the E HEART BIPHASIC DEFIBRILLATOR MONITOR panel 16 1 12 1 PACEMAKER OPTIONAL A Turns on off Enables or disables the pacemaker B MODE Sync or Assync Changes between the VOO and VVI modes
5. Neonatal Oximetry Sensor Figure 12 Capnography Sensors permanent use permanent use accessory Exclusive accessory Exclusive Figure 13 Permanent ECG electrodes permanent use accessory Exclusive Figure 15 3 way Patient Cable permanent use accessory Figure 16 5 way Patient Cable permanent use Exclusive accessory Exclusive US DEFIB MEDICAL TECHNOLOGIES Defibrillator Monitor E HEART Figure 17 Adult Adhesive Electrode Paddles AED and Figure 19 Adult NIBP Cuff Pacemaker disposable permanent use accessory Exclusive Figure 18 3 pole Power Cable permanent use accessory Figure 20 Potential equalization cable permanent use Exclusive accessory Exclusive US DEFIB MEDICAL TECHNOLOGIES Important observation All accessories should be stored in a ventilated place and humidity and dust free In order to clean the paddles and cables use a compress moistened with demineralized water and neutral soap Defibrillator Monitor E HEART o NOJAAN 7 PARTS AND COMMANDS IDENTIFICATION OF E HEART BIPHASIC DEFIBRILLATOR MONITOR Figure 21 Commands identification of the Front Panel Turn the equipment On Off Luminous Alarm Indicator Luminous Battery Indicator Luminous Battery Charging Indicator NIBP Printer Sync Disables alarm for 2 minutes 9 Defibrillator charge command 10 Enables Disables AED Mode 11 Shock trigger command Cancel Charge 1
6. Selects the level of the injected drug Lidocaine Selects the level of the injected drug Amiodarone Selects the level of the injected drug Dofetilide Selects the level of the injected drug Sotalol Selects the level of the injected drug Verapanil Selects the level of the injected drug Drugs 8 and others used in CPR Drugs 9 and others used in CPR OCONOORWND gt 16 1 9 IBP SETUP MENU gt Exit Blood Pressure Maximum Gain Average speed Minimum Alarm Patient Calibrate 1 2 3 4 3 6 Exit Returns to the previous menu Maximum Allows adjusting the alarm range Average Allows adjusting the alarm range Minimum Allows adjusting the alarm range Patient Select patient adult or child Blood Pressure When activated we have access to the following pressure types PVC AD VD PAP PCP AE VE AO PA PIC P1 P2 P3 P4 16 US DEFIB a sim Defibrillator Monitor E HEART 7 Gain The available gains are from 0 5N to 2N 8 Speed Allows to vary the scanning speed of the screen to 12 5 mm s 25 mm s and 50 mm s 9 Alarm Enables YES or disables NO the IBP alarm 10 Calibrate When activated it calibrates the pressure channel with the air measuring subsequently the desired pressure safely 16 1 10 CONFIGURATION MENU OF THE CAP CAPNOGRAPHY Curve Gain Patient Line width Alarm Exit Returns to the previous menu EtCO2
7. 20 28 4 ECG TECHNICAL SPECIFICATIONS Diagnosis 0 05 to 100 Hz Muscular Low pass 35 Hz 5 10 20 mm Vm Tolerance Defibrillation protection Audible beep Calibration sign 1mVpp 3 pimVppt3 o Protection level against electric shocks CF type applied part defibrillation proof ALARMS o ALARMS 25 to 220 BPM Adjust Manual maximum and minimum limits 28 US DEFIB sisi PAPERE Defibrillator Monitor E HEART Silent alarm sound beep disabled for 120 seconds 0 to 7 seconds Table 21 28 5 NON INVASIVE BLOOD PRESSURE TECHNICAL SPECIFICATIONS NIBP Reading range Operation mode Manual automatic Time programming 1 to 60 minutes Protection level against electric shock CF type applied type defibrillation proof Reading range o oo o Maximum blood pressure ALARMS __ o G O Table 22 28 6 OXIMETRY TECHNICAL SPECIFICATIONS 20 to 250 RPM 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 of the sensors Protection level against electric shock BF type applied type defibrillation proof ALARMS ee Manual maximum and minimum limits _ Manual maximum and minimum limits Table 23 29 US DEFIB ial i Defibrillator Monitor E HEART 28 7 DISPOSABLE ACCESSORIES MANUFACTURERS Accessory Module Manufacturer Model ECC ECG ECG Conductive Gel Suprimed Industry and Commerce Ltd R
8. are more general common in everyday life Regarding frequency arrhythmias may be classified as e 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 p A report of the ACC AHA ACP ASIM Task Force on Clinical Competence ACC AHA Committee to Develop a Clinical Competence Statement on Electrocardiography and Ambulatory Electrocardiography ACC AHA Competence Statement 2001 104 3169 3178 24 US DEFIB ih cli Defibrillator Monitor E HEART Types of Bradycardia There are three basic types of bradycardia depending on where the heart s electrical system blockage occurs When blockage occurs in the sinus node which is the heart s natural pacemaker it is called the sinus node dysfunction Besides the blockade of the electrical impulse may occur in the atrioventricular node or the right or left branch of the heart s electrical system The important thing is that all of these types of blocks can lead to reduction of heart rate and cause symptoms such as dizziness and fainting Depending on the type of block and of the symptoms shown it may require a pacemaker implant e Tachycardia it occurs when the heart beats 100 times per minute It usually occurs during physical activity emotional stre
9. at the beginning middle and end of the ST segment Intrinsic deflection time from start of the QRS complex to the peak 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 derivation of the median cardiac cycle is also stored as it is useful for printed reports 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 Nd 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 22 US DEFIB tic am Defibrillator Monitor E HEART All medical criteria used in this ST segment analysis fluctuate from a mere recommendation or alerting about the ECG result
10. basis specific for ECG exams never use other kind of gels for example gel for ultra sound exam Apply the gel only under the contact area of the electrode Never apply abrasive or conductive paste on the injured skin If it is necessary to remove the hair excess perform the trimming and not the shaving of the area 8 Use the proper adhesive tape micro pore or patch on the back of the electrodes and fixate it to the place of contact with the skin certifying that there is a light oressure of the electrode against the skin 9 When the connection is well done if the electrodes are moved you should observe a little momentary artifact with a quick restitution of the trace to normal 10 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 the patient preferentially in a place Slightly different from the previous 11 Clean the skin after the exam applying gauze moistened with neutral soap for complete removal of the conductor gel Pere US DEFIB OW MEDICALTECHNOLOGIES C C CSCSCSCSCSCSCSCSCSCC W ef rillator Monitor _E HEART 12 Clean the electrodes with running water If necessary use water under pressure water pick Dry them totally before storing them A B c Figure B5 ECG with contamination by movement artifacts In A and B the detection of cardiac
11. does not need specific precaution concerning the equipment In NIBP use with cuff which has no metallic wires therefore it does not cause any interference when used together with other High frequency equipment oe Measurement by oscillometer in adult pediatric infantile and neonatal patients Manual and automatic operation mode Measurements of systolic diastolic and average arterial pressure Configurable interval to inflate the cuff SCS 2S e 2S SCS 19 US DEFIB ai it Defibrillator Monitor E HEART Automatic zero before each measurement Alarm of minimum average and maximum pressure PAR Technology 8 7 INVASIVE BLOOD PRESSURE MODULE IBP The invasive blood pressure module IBP presents on the screen the systolic diastolic and average pressures mmHg The E HEART BIPHASIC DEFIBRILLATOR MONITOR is normally supplied with the pressure cable to connect the reusable transducers In the connection of the transducer to the cable observe the narrows that are present on the two pieces that indicate the correct fitting position All of the IBP system should be fulfilled with saline if possible with heparin Make sure that there are no bubbles especially in the tube that goes to the patient Do not use latex in the circuit The transducer must be assembled around the midline of the patient in order to achieve trustable pressure measures 8 7 1 FUNCTIONAL CHARACTERISTICS OF THE TBP The trac
12. of ECG signal 10 Alarm Enable yes or disable no any ECG alarm o1 e WO CO NO 16 1 4 PACEMAKER SETUP MENU Pacemaker gt Exit Frequency Mode Beep Width Pulse Amplitude ok Exit Returns to previous Menu 2 Mode Select Pacemaker operation mode PM of the following modes e VOO The PM send pulses according to configured parameters regardless of any ECG signal detected in patient e 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 30 to 300 ppm pulse per minute Beep Enable yes or disable no pulse beep Pulse Enable yes or disable no the PM pulse sending NOOA 14 US DEFIB i a li Defibrillator Monitor E HEART 8 Alarm Enables YES or disables NO any alarm 16 1 5 SPO2 SETUP MENU gt Exit Max Sat Min Sat Max PPM Min PPM 1 Exit Returns to previous Menu 2 Max Sat Defines the minimum saturation for alarm operation from 40 to 100 3 Min Sat Defines the minimum saturation for alarm operation from 40 to 100 4 Max PPM Defines the pulsation maximum frequency for alarm operation from 40 to 240 ppm 5 Min PPM Defines the pulsation minimum frequency for alarm operation from 30 to 120 ppm
13. on clinical evaluation Prolonged measurement of non invasive blood pressure in automatic mode may be associated with content ischemia and neuropathy in the limbs that are using the cuff When monitoring a patient examine the ends of the members frequently if it presents normal color and temperature and sensitivity If any abnormality is observed stop the blood pressure measurements TN ccs Do not use cuffs and or pipes with water inside with risk to damage the equipment If equipment liquid infiltration occurs turn it off from the electric power grid store it and call a technician to check the equipment 19 US DEFIB iii som Defibrillator Monitor E HEART Arrows indicate maximum and minimum space for cuff use NIBP Module PNI EEE E oS Position reference this patient Cuff extension 2 m Q z F Fia 15 3 The guideline should g limit indicated inside space by two white arrows Fig 16 Cuff correct position indication on the patient Guide line INDEX LINE 17 4 ADAPTING PACEMAKER PADDLES Connect the extension cable on paddles PADs and then insert the other end of the connector to the defibrillator monitor terminal Insert the connector and fasten with moderate pressure So the pacemaker will be ready for application a g Frente Ei Figure 29 Paddles pacemaker position variants on patient Tras The stimulation electrodes should be positioned in a way that d
14. properly observed PAO In special cases if necessary US DEFIB will keep available with agreement all of the 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 MEDICAL TECHONLOGIES LLC US DEFIB _ UV MEDICAL TECHNOLOGIES CSCC fi rillator Monitor E HEART 2 SYMBOLS AND ABBREVIATIONS g Terminal or potential equalization point 4 Dangerous Electric Voltage A N Check attached documents UEN BF type Equipment applied part with patient isolation 9 CF type Equipment with defibrillator protection iT This side up indicates the correct position in which the box should be transported Fragile indicates that the package should be transported and handed carefully Number 5 indicates maximum pilling of five units a Keep dry indicates the package should be kept in dry place x 5 E Indicates medical device and therefore special treatment Indicates composition with recyclable raw material X Symbol for marking of electrical and electronic devices in accordance to the Directive 2002 96 EC The device accessories and packaging must be disposed properly at the end of its use Please follow local ordinances or regul
15. 1 1 PRECAUTIONS AND SPECIAL CARE e Do not place any material on the equipment e Do not reuse disposable materials after its use they should be discarded in appropriate places as special procedures for hospital waste 16 US DEFIB ai it Defibrillator Monitor E HEART e We recommend keeping some auxiliary materials such as surgical scissors disposable razor to remove hair of the chest and disposable gloves if needed 22 1 1 1 PREVENTIVE INSPECTIONS AND CLEANING For longer lifespan of the E HEART BIPHASIC DEFIBRILLATOR MONITOR and its accessories we recommend that the Inspections and Preventive Cleaning are performed regularly as in the chart below Applied Verification Preventive Inspections Half yearly Weekly Table 12 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 22 1 2 PREVENTIVE INSPECTIONS We recommend that an inspection is performed every six months in the E HEART BIPHASIC DEFIBRILLATOR MONITOR and its accessories regardless of whether the equipment was used or not following the instructions below e 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 by the manufacturer US DE
16. 2 External Paddle for Shock Triggering 13 Display 14 Transport handle 15 External Paddle for Shock Triggering US DEFIB tit iit Defibrillator Monitor E HEART 16 Pacemaker on off switch 19 Disables Pacemaker Beep 17 Select between Synchronous and 20 Disables Pulse Asynchronous Mode 21 Navigation Button Browser 18 Pacemaker emergency mode Va L KV Mox AJOA Max 0 Figure 22 Module Identification 1 ECG Connector 4 Adhesive Paddles Connector for MP module 2 External Shock Paddles Connector 5 NIBP Connector 3 Adhesive Paddles Connector for AED 6 SPO2 Connector module US DEFIB _ UV MEDICAL TECHNOLOGIES CSCC fi rillator Monitor E HEART Figure 23 Rear Panel Identification 1 Power Grid Connector 2 Fuse Port 3 Ambulance Inlet Connector 8 E HEART BIPHASIC DEFIBRILLATOR MONITOR CHARACTERISTICS Truncated dual phase exponential waveform with charge of 1 to 200 Joules or optional of 1 to 360 Joules with operating instructions on the panel of E HEART BIPHASIC DEFIBRILLATOR MONITOR or any other energy configuration desired by the user With the equipment powered by electric grid or even powered by the new battery and fully charged its charge time for maximum energy of up to 5 seconds for 200 joules or up to 6 seconds for 360 joules Adaptable to any patient including intelligent safety system that limits the charge for internal use and pediatric neonatal use Patient thor
17. 6 Gain Select the SPO2 amplitude for N 2 1N or 2N 7 Beep Enable yes or disable no the pulses beep 8 Alarm Enable yes or disable no SPO2 alarm 16 1 6 PRINTER SETUP MENU gt Exit Automatic Report 1 Exit Returns to previous Menu 2 Automatic Enable or disable Automatic Printing when blade detects ECG 3 Report Enable yes or disable no the report Printing 16 1 7 NIBP SETUP MENU gt Exit Average Patient Diastolic Mode Start Stop Automatic Alarm systolic 1 2 3 4 Exit Returns to previous Menu Patient Select patient Adult or Child Mode Select measurement mode Manual or Automatic Automatic defines the measurement time interval when the automatic mode is selected 15 US DEFIB ii clit Defibrillator Monitor E HEART 5 Systolic Configures the systolic pressure for alarm triggering from 30 to 300 mmHg 6 Average Configures the average pressure for alarm triggering from 30 to 300 mmHg 7 Diastolic Configures the diastolic pressure for alarm triggering from 30 to 300 mmHg 8 Start Stop Enable yes or disable no NIBP module 9 Alarm Enable yes or disable no NIBP alarm 16 1 8 DRUGS SETUP MENU Exit Lidocaine Adrenaline Mexiletine Amiodarone Noraadrenaline Atropine Potassium Sodium Bicarb Procainamide Calcium Sotalol Dofetilide Verapamil Exit Returns to the previous menu Procainamide
18. ARNINGS FP cree The E HEART BIPHASIC DEFIBRILLATOR MONITOR was designed for cardioversion and clinical monitoring applications with guaranteed operation when used correctly in an appropriate medical place and by qualified personal PP cosines The operator should proceed to check the equipment conditions and its accessories regular tests as well as its operation before use Fy race The operator should have knowledge and be aware of all possible collateral effects that can be caused during use of E HEART BIPHASIC DEFIBRILLATOR MONITOR FT essen The E HEART BIPHASIC DEFIBRILLATOR MONITOR is restricted to one patient at a time and NON FREQUENT USE ee Do not touch the patient the bed stretcher the equipment or any other accessory connected to the patient and or DEFIBRILLATOR MONITOR during the electrical discharge shock Patan When installing the equipment make sure 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 ARNE Equipment and devices connected to E HEART BIPHASIC DEFIBRILLATOR MONITOR different equipment connected to same patient should be connected to perform equal potential among them to obtain perfect potential equalization thus preventing damage to them otherwise the system equipment patient grounding may be compromised Tein There is risk of electric shock if the equipment case is open There are no i
19. Arrhythmias analysis and software for ventilation intubation mode Drugs Calculation Easy to use E HEART BIPHASIC DEFIBRILLATOR MONITOR offers through AED mode the possibility to be used by trained staff and under medical supervision It is highly safe and presents minimum risks for accidents for patient and operator In AED mode optional it provides a voice and text command to instruct the rescuer during the CPR sequence The use of E HEART BIPHASIC DEFIBRILLATOR MONITOR increases human survival rates in a cardio respiratory arrest The E HEART BIPHASIC DEFIBRILLATOR MONITOR could be configured and adapted according to your necessity and be delivered in the following versions 11 US DEFIB i ei ati Defibrillator Monitor E HEART ECG PRI DEFIBRILLATOR MONITOR of ECG Defibrillator and 01 channel Thermal Printer and optionally 02 or 03 channels ECG PM DEFIBRILLATOR MONITOR with ECG defibrillator and external pacemaker transthoracic non invasive multi programmable ECG SPO2 NIBP DEFIBRILLATOR MONITOR with ECG Defibrillator Pulse Oximetry and Arterial Pressure Scouting ECG SPO2 NIBP PRI DEFIBRILLATOR MONITOR with ECG Defibrillator Pulse Oximetry Arterial Pressure Scouting and single channel thermal printer ECG AED MODE DRUG CALCULATION IBP CAPNOGRAPHY Defibrillator monitor with AED voice and text command drug calculation Invasive Blood Pressure IBP Capnography and Telemetry NOTE The E
20. C Inhibits beep Enables or disables the synchronized beep with the pacemaker pulses D Inhibits pulse Enables or disables the pacemaker pulses deflagration E EMERGENCY Changes the pacemaker configuration for the ones from the Emergency Mode VOO 70 rpm 150 mA 40 ms 16 1 12 2 PRINTER OPTIONAL When the key is pressed for the first time the ECG printing gets started when it is pressed again the procedure is interrupted 16 1 12 3 NIBP OPTIONAL When the key is pressed for the first time the Arterial Pressure scouting gets started when it is pressed again the procedure is interrupted 16 1 12 4 SYNC ON Enables or disables the electric discharge with the peak of the R wave 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 led will appear on 16 1 12 5 CANCEL LOAD This key should be activated when the deflagration of the electric discharge is no longer desired in order to discharge the capacitor 16 1 12 6 2 MIN It inhibits the sound alarms for 2 minutes 16 1 12 7 SELECTION MENU It allows adjusting the load level that is going to be used in the next trigger 15 US DEFIB i bint Defibrillator Monitor E HEART 16 1 12 8 LOAD CHARGE lt charges the capacitor preparing the equipment for the next trigger If the equipment is not configured for command by the pad
21. C 60601 1 NBR IEC 60601 1 1 NBR IEC 60601 1 2 NBR IEC 60601 1 4 NBR IEC 60601 2 4 NBR IEC 60601 2 27 NBR IEC 60601 2 30 NBR IEC 60601 2 49 MDD 93 42 EEC EN ISO 14971 2007 EN ISO 13485 2003 and others Protection type against electrical shock Protection rating against electrical shock Applicable of each CF and BF module Closed equipment with splash protection ae IPX4 and projection of water Equipment is not adequate to use in presence of inflammable air mixture O2 and NO with filter 0 5 35 Hz Frequency response without filter 0 5 100 Hz Thermal Printer of High Resolution Thermal Paper 48 mm width x 30m length Paper dimensions 48 mm width x 20m length O i Electroluminescent Color Display 7 in Liquid Crystal Display LCD 745 Opening angle According to harmonized technical standards Use safety rating in presence of inflammable anesthetic mixture Internal power supply DC internal 12 VDC 2300 mAh Lithium Polimer battery LI PO Rechargeable Internal power supply DC internal 12 VDC 2400 mAh Lithium lron LI IR battery optional Rechargeable consecutive shocks respectively Pads output current at 50 ohms 26 US DEFIB ith acm Defibrillator Monitor E HEART Ch lt 5s for 200 J arging time lt 6s for 360 J High impact with electric isolation lt 240ms O Discharge time lt 240 ms Discharge time with synchronism 700 Pa to 1060 Pa 525 mmHg 795
22. CPR sequence SS gt gt 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 E HEART BIPHASIC DEFIBRILLATOR MONITOR will determine if the electrodes don t have the adequate contact with the patient or haven t been correctly connected to the E HEART BIPHASIC 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 4 of the energy for adults automatically When the PEDIATRIC PADDLE is inserted the system 18 US DEFIB ai it Defibrillator Monitor E HEART automatically limits the energy in the proportion of the sequence of the 1st 2 and 3 shocks respectively 19 2 1 RECORDING METHODS FOR AED Mope The possible arrhythmias for TV and VF defibrillation in the equipment eliminating the necessity for operator configuration result significant time gain in the treatment 19 2 2 RHYTHM SOURCE FOR AED Mope Through the Defibrillator Analyzer equipment model QA 40M of METRON Company cardiac rhythms likely to defibrillation are simulated such as TV and VF the natural rhythms in several widths and frequenci
23. CS 2S SCS e hS 15 8 1 e 9 SCS SCS 2S SCS e SCS e SCS 2S SCS SCS 2S SCS e 2S 8 2 US DEFIB aiak re kit Defibrillator Monitor E HEART Memory data card of 250 MB that corresponds to over 100 hours of continuous recording Charge level selection by the APEX Paddle key and charging by the STERNUM paddle key and triggering by pressing both paddles keys simultaneously 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 Pads adhesive Pacemaker transthoracic Pads through reusable defibrillator Pads and or through ECG patient cable Cardiac frequency Any frequency reading frequency from 10 to 300 rom with numerical presentation Protection against defibrillation and cardioversion Filter rejects band of 35Hz and 60Hz pass low frequency 120Hz and pass high frequency 0 5Hz QRS detector Pacemaker detection and rejection Synchronized beep with QRS Display Beep indicator Cardiac Frequency Indicator on display bpm Pacemaker Indicator on display Speed control for curve tracing ECG channel gain control ST Segment and Arrhythmias analysis PATIENT ANALYSIS SYSTEM AED MODE OPTIONAL ECG evaluation automatic system that detec
24. D Stimulator Operation PARNING The described procedure is recommended for support stimulation in bradysystole patient missing intrinsic rhythm In case of bradycardia support should assure that the stimulation frequency is higher than the patient own rhythm and 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 The reduction of the energy delivered to the patient to prolong the equipment battery duration If the patient is conscious seek parameter values that cause less inconvenience to him her E Operation Modes The Pacemaker of E HEART BIPHASIC DEFIBRILLATOR MONITOR features two operation modes 1 VOO 2 VVI In the VOO and VVI modes the Pacemaker will be stimulating and transmitting information to the operator through the display In the VOO mode the pacemaker stimulates the patient continuously In the VVI mode stimulation will only be triggered when the patient natural frequency is below the selected by the operator 22 US DEFIB ih kit Defibrillator Monitor E HEART F Mode Selection You can the operation between Synchronous and Asynchronous mode by pressing the MODE key G Parameter Configuration The parameters are configured inside the pacem
25. FIBDO NORDESTE LTD or any representative e 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 it should be bought new material only by the manufacturer e 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 22 1 3 CLEANING We recommend a cleaning to be performed every three months in the E HEART BIPHASIC DEFIBRILLATOR MONITOR and its accessories following the instructions below e Use a cloth lightly moistened with a solution of 70 alcohol and perform the cleaning of equipment and its accessories e Do not spill any liquid on the equipment and or its accessories 17 US DEFIB _ VET MEDICAL TECHNOLOGIES o Defibrillator Monitor E HEART e Do not immerse the equipment and its accessories in any liquid to perform the cleaning e To perform these cleanups the labels contained in the equipment should not be removed 22 1 4 PREVENTIVE MAINTENANCE The corrective and or preventive maintenance of the E HEART BIPHASIC DEFIBRILLATOR MONITOR must only be performed exclusively by US DEFIBDO NORDESTE LTDA or any representative which frequency of this maintenance is up to the customer in accordance to the table below Mainten
26. FIBRILLATION IMPORTANCE The Early Defibrillation it is a link of the Survival Chain It allows a complete myocardium depolarization enabling 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 most serious arrhythmia characterized by irregular wave s presence in amplitude and frequency defining the chaotic cardiac rhythm In case of VF it is necessary to perform the early defibrillation because the chance for well succeed treatment in these cases decreases quickly as time goes by about 7 seven to 10 ten percent at each minute 16 US DEFIB _UVET_MEDICALTECHNOLOGIES CC C CSCSCSCSCSCSC W fi rillator Monitor E HEART 18 2 THE CARDIOVERSION 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 that the QRS complex is detected by the defibrillator monitor it provides a visual and sound signal Remember that in certain situations there is a mechanism to inhibit the energy exit the signals captured by ECG are difficult to detect for instance when there was a wide and s
27. LASSIFICATION Class Equipment CF and BF Type Equipment internally energized Equipment should not be used near flammable agents like nitrous oxide Intermittent Operation Mode Equipment Equipment not destined for frequent use SSSss The protection rating CF or BF type is according to the module in the equipment and is indicated near the connector of this module 19 2 DETECTOR OF CARDIAC RHYTHM AED MODE OPTIONAL The E HEART BIPHASIC DEFIBRILLATOR MONITOR is prepared to recognized and indicate cardiac rhythms defibrillation of ventricular tachycardia TV of several frequencies and QRS width and rhythms of ventricular fibrillation VF of several amplitudes AUTOMATICALLY remaining for the operator to connect the paddles on the patient chest The rhythm detection system of the E HEART BIPHASIC DEFIBRILLATOR MONITOR analyses the patient ECG and informs if 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 measures for ventricular fibrillation and ventricular tachycardia in victims without pulse The rhythm detection system of the E HEART BIPHASIC DEFIBRILLATOR MONITOR gt Detects contact of the electrode Analyses automatically the ECG Provides orientation for the operator during the therapy of defibrillation It offers voice and text command to instruct the rescuer during the
28. RA right arm represents the chest upper right side Black RL right leg represents the chest lower right side SSSss 16 US DEFIB aiibi et Defibrillator Monitor E HEART Figure 27 Patient electrodes positioning Use water and neutral soap to clean the reusable electrodes After dried disinfect using a moistened compress with ethylic alcohol at 70 Do not use steel sponges on metallic parts because the thin silver layer could be removed and make it useless To clean and disinfect 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 its use they should be discarded in appropriate places following special procedures of hospital waste 17 2 SPO2 OXIMETRY SENSOR Figure 28 Oximetry sensor positioning Connect the oximetry sensor observing the correct position and in a way that the connector is inserted until the end Put the sensor on the patient finger as indicated in the above figure some care should be taken in order to obtain the correct reading e Remove enamel and dummy nails because th
29. TOR MONITOR Above the frequency range of 150 KHz to 80 MHz the field intensity should be smaller than V1 V m Table C3 20 US DEFIB ii iia cobs Defibrillator Monitor E HEART 32 TECHNICAL ASSISTANCE US DEFIB MEDICAL TECHNOLOGIES Permanent Technical Assistance Mr Owner The US Defib Medical Technologies LLC has available a large list of representative and technical support In order to be able to offer a personalized service we ask you to send a registering form lt seeks to update our databank to better address authorized technical support service for each region training and others For complaints doubts suggestions and technical support contact with our CAS Customer Assistance Service bellow US DEFIB MEDICAL TECHNOLOGIES Manufacturer US Defib Medical Techonlogies LLC Address 7831 NW 72 Avenue Medley Miami na Zip Code 33166 Phone 1 305 8877552 1 305 8877541 Legal Representative Amanda Coelho Rodrigues Felix OBELIS s a EC AV DE TERVUEREN 34 BTE 44 BRUSSELS CITY BELGIUM 21 US DEFIB MEDICAL TECHNOLOGIES Defibrillator Monitor E HEART CUSTOMERS REGISTERING TEMPLATE US DEFIB MEDICAL TECHNOLOGIES EQUIPAMENT DESCRIPTION Serial Number DESFIBRILLADOR MONITOR E HEART CUSTOMER NAME ADDRESS TECHNICAL SUPPORT Attention Mr Owner Please fill in the blanks above in order to update our databank for questioning and make sur
30. US DEFIB _ UV MEDICAL TECHNOLOGIES CCC fi rillator Monitor E HEART User Manual Defibrillator Monitor E HEART E HEART SF US DEFIB LLLLLLLIN Hitl US DEFIB MEDICAL TECHNOLOGIES Manufacturer US Defib Medical Technologies LLC Address 7831 NW 72 Avenue Medley Miami pas Zip Code 33166 Phone 1 305 8877552 1 305 8877541 Legal Representative Amanda Coelho Rodrigues Felix OBELIS s a EC AV DE TERVUEREN 34 BTE 44 BRUSSELS CITY BELGIUM O an SGS 0120 US DEFIB ii i la Defibrillator Monitor E HEART FOREWORD Congratulations for acquiring a US DEFIBequipment This product incorporates up to date technology We are sure you will be very satisfied with E HEART BIPHASIC DEFIBRILLATOR MONITOR READ ALL OF THE OPERATION INSTRUCTIONS BEFORE operating E HEART BIPHASIC DEFIBRILLATOR MONITOR This User Manual contains all of the necessary information for a complete interaction with the equipment from information concerning operation to necessary care for better conservation of E HEART BIPHASIC DEFIBRILLATOR MONITOR This equipment should only be used by a well trained professional to provide advanced life support After you finish reading the entire User Manual keep it protected so you can check it at any moment A future reference could be necessary for new users The permanent consultation of this manual is a requirement to obtain better equipment performance correct operation a
31. acic 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 key 14 US DEFIB ii acl itm Defibrillator Monitor E HEART L2 e Clock date and shock counter e Clear phase identification charging ready discharging and disarming Use of reusable electrodes permanent adult pediatric interchangeable paddles that needs activation of two simultaneous controls one in each paddle Performs self test when switched on Rechargeable internal battery with manageable charger with alarms and status indicator for several levels low level charging medium and high and full charge with indication in approximately 6 levels on the display Capacity to perform up to 220 discharges with full load new battery fully charged External reserve batteries with internal charger optional Electroluminescent liquid crystal display that shows signal of ECG SPO2 optional Capnography and invasive blood pressure optional Non invasive blood pressure optional derivation cardiac frequency beep indicator battery status alarms pacemaker pulse programming parameters indicating the selected energy for triggering Event memory including curve date and hour optional of approximately 250 MB that corresponds to over 100 hours of continuous recording Indicates mode and charge val
32. ain accurate values of pressure 17 10 INTERNAL BATTERY The E HEART BIPHASIC DEFIBRILLATOR MONITOR has a rechargeable internal battery which allows operation without power grid cable The battery charging is automatic when you connect the power cable to electric power grid 127 and 220 V regardless if equipment is switched on in upper panel User should proceed to check or replace the internal battery through US DEFIB when observing degradation in the useful charge time IMPORTANT The DEFIBRILLATOR MONITOR battery should be returned to manufacturer after a substitution motivated by defect or end of useful life 7 esata The E HEART BIPHASIC DEFIBRILLATOR MONITOR should remain connected to the power grid 24 hours a day in order to keep the battery fully charged the equipment is also able to operate normally when connected to the POWER SUPPLY 18 FOUNDATIONS 18 1 DEFIBRILLATION CONCEPT The Defibrillation is the emergency procedure that consists in the application of an electric current shock non synchronized on 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 pulsation It should be differentiated from Cardioversion that consists in an elective or emergency procedure that needs synchronization and is classically indicated in instable tachycardia cases or with medical criteria 18 1 1 DE
33. aker menu Press the Browser menu to enter main menu rotate the Browser until the Pacemaker menu and press it again Navigate until the desired parameter press the button again turn it to alter and select the Navigator to confirm H Emergency Regardless of the operation mode selected for the E HEART BIPHASIC DEFIBRILLATOR MONITOR Pacemaker when you press the EMERGENCY key the pacemaker changes to VOO mode and takes on the following parameters 100mA 20ms and 7Oppm SWITCH ON AND OFF PACEMAKER In order to turn the pacemaker on or off you should press the following button check page 40 item 3 5 I Pacemaker Specifications Stimulation configurable parameters Frequency Amplitude and Pulse width Current stimulation without any charge connected 100mA off 3mA Power supply 12V Stimulation system specifications Stimulation frequency 30ppm to 200ppm in steps of 1ppm Pulse amplitude OmA to 200 mA in steps of 1mA Pulse width Oms to 50ms in steps of 1ms Emergency VOO 70ppm 100mA 20ms Defibrillation protection 400 joules Location of stimulation electrodes The stimulation electrodes should be positioned in a way that does not interfere with a possible defibrillation Normally the non invasive stimulation is performed in the Apex Front and Front Back configuration Nevertheless we recommend the Front Back configuration to ease the defibrillation procedure if necessary 23 US DEFIB i kit Defi
34. al 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 following is a list of medical criteria ANVARNING The interpretive ST segment analysis report using the E HEART BIPHASIC DEFIBRILLATOR MONITOR is one of the valuable tools that helps the physician to interpret ECG efficiently but only if combined with a detailed patient history and medical exams All computerized ECG system is unable to analyze the ECG waveform as the human eye brain system The physician should re read and correct the automatic ECG interpretation report FP cei The ACC AHA recommended the computerized interpretation of ECGs to doctors 23 US DEFIB i kit Defibrillator Monitor E HEART 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 Japa
35. alance 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 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 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 from 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
36. ame time In case of doubt disconnect the ECG cable v This equipment may cause radio 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 location shielding 15 CARE WHEN APPLYING DEFIBRILLATION CARDIOVERSION v Do not place the paddles directly on ECG electrodes Some care should be taken with patients on pacemaker in order to avoid damages to device and to patient himself e hS The applied energy should be the lowest possible Keep an external pacemaker nearby Check pacemaker after defibrillation Keep distance between the generator and the patient pacemaker and the defibrillator monitor paddles SCS e SS hS IMPORTANT e The protection against the defibrillator discharge effects is located in the intern modules of the equipment e The cable electrodes and accessories don t have protection against burn outs caused by the use of high frequency equipment 16 OPERATION MODE 16 1 EQUIPMENT CONFIGURATION When you press the navigation button of E HEART BIPHASIC DEFIBRILLATOR MONITOR the Configuration Menu modules will appear on the display A cursor with an arrow shape gt appears at left of the items of this menu indicating that this is the selected item one By rotating the navigation button clockwise or anticlockwise the cursor moves to a new menu item according to rota
37. ance Frequency Indication Every 3 months Half yearly Annually Mandatory Table 13 E HEART BIPHASIC DEFIBRILLATOR MONITOR requires no periodic calibration because it is calibrated at the factory according to technical specifications without the need of new calibrations 23 ADDITIONAL INFORMATION The E HEART BIPHASIC 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 the E HEART BIPHASIC DEFIBRILLATOR MONITOR US DEFIB Medical Technologies LLC Relates 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 For better clarifying doubts or request for Technical Assistance please contact US DEFIB MEDICAL TECHONLOGIES LLC US DEFIBMEDICAL TECHNOLOGIES LLC www usdefib com or info usdefib com 24 TROUBLESHOOTING The user should always verify the conditions of the equipment This section has the purpose of solving functionality problems of the E HEART BIPHASIC DEFIBRILLATOR MONITOR The solutions suggested here involve common procedures that are easy for 18 US DEFIB ih cli Defibrillator Monitor E HEART the User to solve These procedures do not involve the opening of the main cabin
38. ations for disposal 3 MEASUREMENT UNITS Symbols Unit Description Length Meter centimeter millimeter Hour minute second millisecond Kilogram gram US DEFIB ith acm Defibrillator Monitor E HEART Me mint 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 cHb Hemoglobin concentration HbOz2 Oxihemoglobin CHbO2 oxihemoglobin concentration PRI Printer INCOR Heart Institute LDE Light Diode Emissor LCD Liquid Crystal Display PM Pacemaker SAN Sinu atrial Node ABP Arterial Pressure CPA Cardio respiratory Arrest NIBP Non Invasive Blood Pressure IBP Invasive Blood Pressure DBI Defibrillator CPR Cardiopulmonary Resuscitation BCS Brazilian Cardiology Society SPOz2 Oxygen Saturation VT Ventricular Tachycardia UTI Intensive Care Unit VOO Pacemaker Asynchronous Mode VVI Pacemaker on Demand Mode 10 US DEFIB hi tint Defibrillator Monitor E HEART 5 DESCRIPTION OF E HEART BIPHASIC DEFIBRILLATOR MONITOR AND ITs COMPONENTS 5 1 PRESENTATION The E HEART BIPHASIC DEFIBRILLATOR MONITOR is a portable and dual phase equipment truncated dual phase pulse It can be used in any position in ground hospital environment in the surgical be
39. brillator Monitor E HEART After the connection of both units with interface cable and switching on the pulse generator you should press the EMERGENCY key to select the more suitable stimulation In this configuration the Front Electrode 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 v Remove or loosen the patient cloths v Clean and dry the skin area with a dry cloth v Check the expiration date of the stimulation Pads v 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 v lf the electrode does not adhere adequately discard it and repeat the previous steps with a new pair v Insert the self fixing connector indicated on the electrodes cable end to the correspondent extension cable connector of E HEART BIHASIC DEFIBRILLATOR MONITOR v In case of doubt always follow the instructions indicated by the stimulation electrodes manufacturer 17 6 ADAPTING THE DEFIBRILLATOR MONITOR PADDLES At the trigger moment conductive gel should be on the paddles that should be firmly positioned as on the figure and the paddles trigger keys pressed simultaneously Figure 30 Shock Paddles P
40. cessary to be careful not to discharge the defibrillator during the vulnerable period because in that case a ventricular fibrillation could be induced v A special care should be taken regarding the different use conditions of the equipment Defibrillation or Cardioversion 24 US DEFIB it kit Defibrillator Monitor E HEART To use the equipment as a defibrillator if the synchronism function is on it will not perform the shock in the cases of ventricular fibrillation VF or Asystole even when the paddles 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 make the user think that the equipment has a defect but actually the 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 presence of the R wave Consequently in the randomness of the trigger the shock can occur during the vulnerable p
41. compartment as shown in figure A 1 and figure A 2 below 1 a Introduce the screwdriver in the fillister of the fuse compartment and press it moderately until it reaches the limit 1 6 Still pressing the screwdriver turn it approximately 45 on the counterclockwise until it reaches the limit Now just remove the screwdriver and the set will be released for the fuse removal Check if the fuse is broken observing a thin wire in its interior figure A 2 If it is replace it with the reserve or with another from the same type and characteristic 1 c To replace the fuse in the fuse compartment proceed the opposite way changing only the screwdriver turn figure A 1c on the opposite way CONDUCTIVE THIN WIRE i SCREW DRIVER Figure A 1 Figure A 2 Procedure for fuses replacement AN warnine Always when withdrawing or replacing the fuse do it with the equipment off 31 US DEFIB si ci aah Defibrillator Monitor E HEART 30 APPENDIX B ECG TRACE INSTABILITY AND NOISES When you realize 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 2 9 Status of the electrodes connection cable Observe the existence of cracks or breaks over the cable that must be homogenous in all its extension Integrity of cable extremities and junct
42. ctures below The capnography can be damaged because of the reuse of the water filter Follow the accessories use instructions The filter should be replaced at every patient according to the manufacturer instructions 14 US DEFIB MEDICAL TECHNOLOGIES Mean stream Capnography Module Fig 40a Fig 40b Defibrillator Monitor E HEART Side stream Capnography Module Side Stream System Mean stream System Place the adaptor in luo tha mcitinn acin th Insert the Plug the position as in the i moi figure bellow peu dnan indicated Sensor Front sensor View as inthe figure gt Sensor adaptor Figure 34 Mean Stream Assembling Design 17 9 USING THE IBP INVASIVE BLOOD PRESSURE In case of using 2 channels of pressure 2 systems should also be used Material needed 01 disposable dome 01 syringe 02 three ways 01 extensor First add the two three ways to the dome this increases security and makes the work easier Connect the dome to the pressure transducer To connect the dome to the transducer the system should be opened for the air e All of the system bellow should be filled up with the saline and if possible with heparin US DEFIB i ei tit Defibrillator Monitor E HEART 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 midline of the patient if not the values o
43. d and benches rescue units by air or land providing better handling in advanced life support This equipment was designed to apply electric stimulus to the heart in cases that the cardioversion and or defibrillation are indicated This revolutionary defibrillation technology requires less energy than that used by conventional single phase DEFIBRILLATOR MONITOR producing a better performance This equipment is indicated for adult and pediatric use and it integrates several functions like Defibrillation ECG Monitoring Non invasive Blood Pressure NIBP optional and Invasive Blood Pressure IBP optional Oxygen Blood Saturation Scouting SPO2 Capnography monitoring optional and an external Pacemaker with non invasive multi programmable module asynchronous and by demand and switching for emergency modes also presents a Thermal Printer optional The ECG can be captured by monitoring electrodes and by the external defibrillation paddles allowing event memorization Compact Flash The DEFIBRILLATOR MONITOR has a high resolution and high contrast liquid crystal display LCD that allows perfect visualization in different angles with the exclusive Lap Top check page 14 figure 2 for cardiac monitoring It also has a microprocessor for heart activity analysis which takes approximately 10 seconds ECG analysis ventricular fibrillation ventricular tachycardia and optionally it can be supplied with the software for ST Segment and
44. d grounding described in this manual see page 50 Proximity to external interference sources radio frequency generators and power lines if that occurs move them away 10 Equipment filters adjustment 11 For additional support don t hesitate to contact US DEFIB MEDICAL TECHONLOGIES LLC US DEFIB ith siti tabi Defibrillator Monitor E HEART 30 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 Figure B1 Noiseless Electrocardiogram 30 2 AC POWER SUPPLY 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 gt Presence of magnetic fields next to the equipment and electrode cables as X ray electrical transmission lines reactors for fluorescent lamps and so on gt Insufficient connection to the grounding gt Electrode cable of the patient and supply cable crossing gt 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 dama
45. dles buttons the capacitor will only be charged if this key is pressed 16 1 12 92 SHOCK TRIGGERING When activated it performs the treatment The treatment can also occur when both of the blade buttons are activated simultaneously NOTE lf the equipment is configured for command through the paddle buttons there will be the following functions 1 Sternum gt Loads the capacitor 2 APEX gt Select 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 its own shock paddles by pressing simultaneously both the keys of the paddles 16 1 12 10 AED MODE When the AED mode is activated the equipment performs the functions of an AED automatically to exit the AED mode you just have to press the AED key again on the control panel 17 ADAPTING CABLES AND ACCESSORIES 17 1 ECG MODULE Connect the patient cable to the defibrillator monitor observing the correct position through 5 ways 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 drawing indicated positions as in figure 31 using the color in the correct place for each wire Blue V precordial represents the six precordial Green LL left leg represents the chest lower left side Yellow LA left arm represents the chest upper left side Red
46. e BPM 001 mute 009 max Volume key Sets the volume of the keyboard beep mute 001 max 004 Beep key Enables YES or disables NO the beep sound on the keyboard Language PTG Portuguese English ENG SPA Spanish Time Changes the Time Sync ON Enables YES or disables NO the synchronism with the QRS signal of the ECG sign 9 Auto Charge Enables YES or disables NO the defibrillator charge automatic sequence ONDOORWD 32 US DEFIB ii acl itm Defibrillator Monitor E HEART 10 Paddles Selection Enables YES or disables NO the paddles button command 11 Date Adjust Day Month Year 16 1 3 ECG SETUP MENU ELECTROCARDIOGRAM gt Exit Derivation Filter 60Hz Filter 35Hz Tachycardia Bradycardia 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 Filter 35Hz Enable yes or disable no 35 Hertz filter Tachycardia Defines the bom value for alarm operation in tachycardia 100 220 Bradycardia Defines bpm value for alarm operation in bradycardia 30 60 Speed Select the sweeping speed of ECG for 12 5 25 or 50mm s Gain Select the ECG amplitude for N 2 1N or 2N Beep Enable yes or disable no the synchronism beep with QRS complex
47. e indicated transthoracic applications of pacemaker are 17 US DEFIB hii it Defibrillator Monitor E HEART gt Treatment of symptomatic bradycardia or bradyasystole during emergency gt During and after cardiac surgery gt To ease the insertion of a transvenous stimulator electrode 8 5 1 PACEMAKER CHARACTERISTICS v External pacemaker transthoracic non invasive multi programmable in modes on Demand assynchorouns 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 30 and 200 bpm Other frequencies may be optionally configured according to the user choice Note The operator can control the stimulation process by means of E HEART BIPHASIC DEFIBRILLATOR MONITOR keyboard The stimulation pulse application can be visualized through a panel LED v 3 pacemaker operation modes are possible 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 menu value remaining the stimulus until the patient natural cardiac freque
48. e is shown continuously on the screen Option to select the blood pressure types AP AO LV AE PVC AD RV PAP PCP PIC Right Left Esf Maximum average and minimum blood pressures shown continuously on the screen mmHg e Manual control of gain of 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 oe SS hS e 2S 8 8 CAPNOGRAPHY MODULE ETCO2 The Capnography module uses the Sidestream and Mainstream sensors miniaturized with optional procedure of auto calibration that dismisses the use of specific gases for periodic calibration It presents to the user the following parameters e Exhaled CO2 curve showed continuously on the screen e Value of the exhaled CO2 e Minimum of inhaled CO2 e Respiratory frequency value After connecting the sensor it is necessary to wait for approximately 1 minute in order to set up to be ready for the measurements After this while a light must be observed on the sensor indicating its habilitation Once connected to the respirator tube we ll 20 US DEFIB le sit Defibrillator Monitor E HEART have the patient information The Capnography sensor should be on the adaptor to avoid the condensation if that occurs interfere on the
49. e you send us the registration form in order to get a customized service 22 US DEFIB MEDICAL TECHNOLOGIES Defibrillator Monitor E HEART SS SS E SS SS S SS E S je al Ss at oe SIE SHER ke M V A a S ae gt gt l gt p eN Pal Pal Pal US DEFIB MEDICAL TECHNOLOGIES LLC WARRANTY CERTIFICATE Ss Sz pm N SJ SI eS eZ LA SJ SS ea S amp S SJ Sy AJAS uss A az SJ SS Sa ai SJ A S gt aS SJ D I amp A ZA Aaz SJ ZAI Al SS E E D CaS SI SJ eS Ss AI A S gt aS SI Al az
50. ectromagnetic Environment resistance test ABNT NBR IEC level Orientation i 8 US DEFIB _ VET MEDICALTECHNOLOGIES CSCW fb rillator Monitor _E HEART EE 60601 oS Static Electricity Discharge SED 6kV per contact The floors must be made of wood or cement and should have according to IEC 8kV by air Conform ceramic tiles If the floor is made of synthetic material the relative 61000 4 2 humidity must be of at least 30 Fast transient aleciric in the supply disturbances l 1kV in the input omen Electricity supply quality should triggers accoraing output lines correspond to the voltage supplied to IEC 61000 4 4 p eny ge supp ie in a typical commercial Over voltages m au rer environment or hospital according to IEC Keomo Conform 61000 4 5 mode lt 5 Ut gt 95 of voltage The quality of the supplied voltage drop in Ut for 0 5 quality should correspond to the cycle voltage supplied in a typical 40 Ut commercial environment or Voltage drops 60 of voltage hospital If the user of the E brief interruptions drop in Ut for 5 HEART BIPHASIC and floatation on cycles Conio DEFIBRILLATOR MONITOR the supplied 70 Ut requires continuous operation voltage according 30 of voltage even when there are interruptions to IEC 61000 4 11 drop in Ut for 25 on the electricity supply the E cycles HEART BIPHASIC lt 5 Ut DEFIBRILLATOR MONITOR gt 95 of voltage should receive ene
51. egister in Ministry of Health od Brazil 80184040004 Gel In Shape 3M do Brasil ECG Disposable Electrode Adult Electrode Model Register in Ministry of Health od Brazil 10002070152 Child Neonatal Electrode Model Adult Pediatric Electrode Model Thermal Sensitive Paper Daru Register in Ministry of Health od Brazil Not required 48mm x 16mm x 30m thermal paper Pacemaker Paddles set PADs sone a AED Mode Paddles Set PADs FIAB SpA exclusive use F 959 F7959P Table 24 28 8 PERMANENT ACCESSORIES MANUFACTURERS Accessory Module Manufacturer Model ECG bse cS ns Se eS 5 ways patient cable exclusive use BIO LIGHT or GE DINAMAP 3 ways patient cable exclusive use BIO LIGHT or GE DINAMAP Permanent Electrodes POLIMED AG802 SPOR SPO gt Adult Sensor BIO LIGHT or NELLCOR BIO LIGHT or NELLCOR SPOsz Y Pediatric Sensor BIO LIGHT or NELLCOR Others US Defib n AC 0015 EX Invasive Blood Pressure Sensor Clamp Support Sergeant US DEFIB iti i Defibrillator Monitor E HEART NIBP Cuff BAUMANOMETER Transducer support MEDEX n MX262 Table 25 29 APPENDIX A FUSE REPLACEMENT 29 1 FUSE CHANGE 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 With the help of a screwdriver remove the cover of the fuse
52. ent circuit control of battery charging 2 Optionally with sealed lead acid battery 3 Optionally with external battery for ambulances aircraft Y In occasions when there is no power grid available by periods of long use don t use the network cable when the power supply cable for ambulances is used for ambulance 28 US DEFIB ai kit Defibrillator Monitor E HEART 4 Optionally with external batteries Spare with its own charger with a maximum charge time of approximately 4 hours v External batteries can be delivered in different charging capacity versions that varies between 2 and 15 hours of monitoring or 50 to 200 consecutive shocks respectively with a proper charger v External Batteries are easily replaced battery interchangeable Tee The E HEART BIPHASIC DEFIBRILLATOR MONITOR can remain connected to the power grid 24 hours a day to keep the battery fully charged and it is also able to operate normally 11 3 DIGITAL STATUS OF BATTERY LOAD In the panel of equipment is an LED indicator such as below of v v 11 4 SSS 12 Connected to the power grid AS Battery status gt Loading ma O TT mG Battery status 7 Discharged pes TTI a TRANSPORT CONDITIONS Ambient temperature range from 40 to 70 C Relative humidity range from 10 to 100 Atmospheric pressure range from 700 hPa to 1060 hPa 525mmbHg to 795mmHg EQUIPMENT INSTALLATION AND HANDLING RECOMMENDATIONS Avoid tu
53. ent or disposable electrodes of good quality All of these procedures must be followed independently of the patient Adult or Pediatric Neonatal Other standard procedures should be followed too already mentioned in the E HEART BIPHASIC DEFIBRILLATOR MONITOR Description and its components item Presentation of this manual See page 11 26 2 NON INVASIVE BLOOD PRESSURE NIBP v 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 compatible with it and avoid this way the circulation interruption 26 3 OXIMETRY MODULE v 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 v Neonatal and pediatric patients require special care using another type of sensor model on Y format its position must be changed every 2 hours to avoid possible skin burn bruises or lesions to the skin This application on a neonatal patient is performed by fixating an adhesive tape that cannot be used excessively to avoid lesions to the skin or incorrect readings v Other standard procedures listed in this manual see pages 19 and 31 should also be followed 26 4 DEFIBRILLATION MODULE v It is ne
54. erence gt Presence of strange particles dirt for example between electrode and patient skin gt 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 I Lam i at A alla 7 a al pal a i i Figure B4 ECG with oscillation on the baseline drift 30 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 O and 300 ppm with a 3 accuracy transforming the ionic activity of the skin surface that reflects the internal electrical generators among them the cardiac activity in electrical current US DEFIB wi iii eh Defibrillator Monitor E HEART 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 b
55. eriod and cause ventricular fibrillation 26 5 INVASIVE BLOOD PRESSURE MODULE 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 26 6 CAPNOGRAPHY MODULE The adaptors should be verified both in the side stream system and in the mainstream system to check if they are clean sterilized in perfect condition to avoid a possible bacterial contamination 27 ADVERSE EFFECTS The US DEFIB manufacturer of hospital medical equipment requests the users to report possible defects or occurrences of any undesirable event with the purpose to warrant the equipment quality Therefore any flaw or mal function contact the nearest Authorized Technical Support or directly with the sale consultant on our web site www usdefib com or Phone 1 305 887 7552 7541 Important Observations Do not apply shock with short circuited paddles in because the trigger device could be damaged For the functionality test of the defibrillation trigger at the triggering terminals there must be an interval between the discharges and charges of at least 30 seconds Always transport the equipment with Pads inside its transport case 25 US DEFIB i cit Defibrillator Monitor E HEART It is recommended maintain the patient totally immobile during ECG analysis with the purpose to avoid reading errors 28 TECHNICAL SPECIFICATIONS NBR IE
56. es 19 2 3 RHYTHM SELECTION CRITERIA FOR AED Mope The selected rhythms are the well known classic indication for defibrillation such as ventricular fibrillation and ventricular tachycardia 20 NOTE METHODS The E HEART BIPHASIC DEFIBRILLATOR MONITOR is equipped with an electroluminescent liquid crystal display where the emergency attending procedures and ECG tracing are plotted allowing cardiac rhythms graph registration 20 1 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 stop 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 19 US DEFIB i ic ahi Defibrillator Monitor E HEART 21 APPLIED TECHNOLOGY 21 1 COMPARATIVE MONOPHASIC X BIPHASIC The defibrillation pulse waves are classified into monophasic and biphasic In the monophasic type the polarity is constant the biphasic type the current is conducted in one direction the polarity is reversed in the opposite direction after a short pause the waves are also classified according to the form and t
57. et AT ALL of the modules or the permanent accessories If 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 e The conditions of the cabinet if it is in one piece or presents any cracks or dirty e The battery conditions if it is charged or not e Are all the accessories required for the use present adults or pediatric electrodes patient cables oximetry sensor among others e Are the accessories in good conditions PROBLEM RECOMMENDED ACTION The E HEART BIPHASIC Check the tripolar supply cable making DEFIBRILLATOR MONITOR does not sure that it is correctly connected to the turn on electricity The supply cable is in perfect conditions Check the security fuse located at the but still the E HEART BIPHASIC back part After disconnecting the DEFIBRILLATOR MONITOR does not equipment from the electricity open the turn on fuse 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 3A 20AG see Appendix A Instability of the parameter curves The main causes of the trace instability are bad sensor and electrodes connection in the patient and the lack of grou
58. ey can block the sensor light blocking the correct reading 17 US DEFIB ii clin Defibrillator Monitor E HEART e Do not use adhesive to fix sensor like plaster for instance The sensor is a very fragile device e Avoid dropping or leaving it on floor e For reusable sensors after its use clean the cable and sensor with a cloth moistened with demineralized water and neutral soap Disinfect with an isopropyl alcohol moistened compress 17 3 ADAPTING THE NIBP CUFF This topic was elaborated to the ones that are operating the equipment for the first time It allows a very simplified basic functions training of NIBP channel This channel provides diastolic average and systolic arterial pressure The Non invasive Blood Pressure Module NIBP has discharge protection against cardiac defibrillator and specific precaution concerning the equipment is not necessary lt was detected damages to the Ulnae nerve during the use of blood pressure automatic cycle in some researches A special attention is required not to block the patient s blood circulation e Do not leave the cuff over the elbow Ulnae nerve path e Select a measurement interval that regulates the adequate venous drain during cuff deflection e Check periodically the member that support the cuff to discover Venous Stasis e Avoid compression or restriction of pressure pipes this can cause the equipment mal function Connect the air hose to the cuff and the socke
59. f it is performed incorrectly the next steps will 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 21 US DEFIB itt Defibrillator Monitor E HEART 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 if the duration of the PR interval is varying 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 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 SCS 2S 2 hesa SCS 2S Ss hS SCS 2S SCS hS SCS 2S SCS hS SCS 2S 9 Duration of normal QRS complex 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
60. f pressure will not be accurate The path of the IBP system should be inspected observing the existence of air bubbles in these ways If there are air bubbles they should be eliminated by letting the saline flow all the way until we can verify that there are no such bubbles in the IBP system For IBP Calibration we have NOTE Before calibration check the correct assembly of the blood pressure measurement system select the channel of the blood pressure and close the 3 way so that the transducer is closed for the patient Open the 3 way for the air and hit ZERO After the ZERO O appears the equipment will be able to measure the pressure Now just close the 3 way In order to measure the pressure of the RV right ventricle and LV left ventricle the pressure to be measured must correspond to the pressure type displayed in the equipment since that measurements don t have an average pressure value The tolerance for calibration is within the interval of 100 mm Hg ft Sensor Module Connection Cable IBF Sensor IEP Sensor Figure 35 IBP Assembling Design IMPORTANT The whole IBP system should be filled with saline if possible with heparin Make sure that there are no bubbles especially in the tube that connects to patient Do not use any 15 US DEFIB ai it Defibrillator Monitor E HEART latex in the circuit The transducer should be placed around the middle line of the patient in order to obt
61. g agents Do not operate it in presence of inflammable gases in general 11 2 POWER SuppPLy BATTERY 11 2 1 LITHIUM POLYMER LI PO Rechargeable Lithium Polymer Li PO with specific manageable battery charger internal to the equipment For a long lifespan keep the charger connected to the equipment and the power grid With a capacity of up to 150 shocks at 200 J and up to 6 hours of monitoring when the battery is fully charged new battery fully charged This device has an internal intelligent battery charging control circuit Remembering that this battery LI PO should have special attention as described below AANG Do not use any battery charger other than the one recommended by US DEFIB MEDICAL TECHONLOGIES LLC Do not short circuit the battery Charge in a well ventilated location Do not discharge the battery completely Do not compress or disassemble it i 7 Risk of burns fire and explosion if the recommendations above are not followed h N Optionally with Lithium lron Battery LI FE Lithium lron LI IR rechargeable battery with a proper manageable charger internal to the equipment For a prolonged lifespan keep the charger connected to the equipment and the power grid With a capacity of 6 hours of monitoring battery fully charged or at least 160 shocks at 360 J or 220 shocks at 200 J when the battery is fully charged new battery fully charged This device has an internal intellig
62. ganic solvents chloride alcohol or hydrocarbon solvents To prevent scratches on the panel exhibition screen display wipe carefully with a dry flannel or in case of dirty a cloth lightly moistened in water and remove dust or dirty particles The labels existent on equipment are important and for this reason cannot be removed The cleaning and disinfection of permanent cables should be done at every equipment use This cleaning is performed with a cloth lightly moistened with demineralized water and neutral liquid soap After it dries disinfect it using a moistened compress with ethylic alcohol at 70 For disposable electrodes and accessories after use they should be discarded in appropriate places according to special procedures for hospital waste For the capnography sensor cleaning after the use use a cloth moistened in demineralized water with a small quantity of neutral liquid soap and for disinfection use gauze moistened in isopropyl alcohol The pipes water filter side stream water trap mainstream sensor adaptor and miscellaneous are considered disposable they must not be reused and should be disposed in hospital waste according to each hospital procedure e 21 US DEFIB ih im Defibrillator Monitor E HEART To clean the NIBP and hose use a mild solution of soap and water and do not immersed it in chemicals detergent and water Accidental entry of fluid in the tubing or bladder can damage
63. ged cable gt 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 lili Figure B2 ECG with 60 Hz interference on the AC Power Supply SS 30 3 MUSCLE 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 US DEFIB ii iit Defibrillator Monitor E HEART gt Undquiet patient due to cold or discomfort during the exam gt Specific pathologies for example Parkinson s Disease Figure B3 ECG contaminated with muscular artifacts muscle tremors 30 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 raise difficulties to the exam figure B4 The main causes are related as follows gt Inappropriate connection of the electrode to the patient with little gel or using worn out electrodes gt Fixation tape of the electrodes poorly positioned or without adh
64. he one indicated in the USER MANUAL 3 The equipment was used with cables sensors accessories or consumable materials not indicated by US DEFIB or outside normal use conditions as expiry date or period or use 4 The customer will lose his warranty right during the mentioned period of 12 twelve months if the equipment a had a maintenance or repair performed by a non authorized professional according to the list provided by the manufacturer b was used in a way different than the one described in the user manual c suffer any damages caused by accidents and natural phenomenon 5 The manufacturer will not be responsible for expenses related to installations damaged products or accessories due to transport accident handling scratches kneading non operation or flaws caused by electric energy supply shortage WY A I eB SZ WN SY eA ZAS gt I AA E SI SS AS A
65. he paper roll with the printed millimeter part upward Place both roll sides holes until the side clamps fit inside depending on the model After the roll placement leave some paper spare outside of the printer and place the lid on horizontal position Pull the paper outward the printer and position it centralized related to paper passage slot Push the printer lid so it locks Then it is ready to use see next illustration 17 7 1 INSTRUCTIONS TO PLACE THERMAL PAPER IN THE TR 50 OR SP 48 PRINTER sa gur S 2 Move the lid until it is positioned at 70 9 3 Enter the print platen in the loop and print side up 4 Drag out the paper centering 5 Lift the printer cover in the opposite direction ensuring that it doesn t lock a 1 Press the cover latch 25 US DEFIB sith i ia Defibrillator Monitor E HEART Figure 32 ai SV Ps oa 6 Set the print paper again so that it centralizes with the printer oo 7 After the correct positioning of the ee paper press the printer cover until it locks After locking the lid the pe equipment will be ready for use If the A paper does not move properly during ra printing repeat the procedure Figure 33 17 8 USING CAPNOGRAPHY AND SENSORS The E HEART BIPHASIC DEFIBRILLATOR MONITOR can use either the nasal line or intubated for the capnography To use the capnography in intubated patients adaptors should be used as shown in pi
66. he standard NBR 13534 Electrical Installations on Health Assistance Establishments Requirements for safety published by ABNT in November 1995 In the lack of power supply the E HEART BIPHASIC DEFIBRILLATOR MONITOR starts to operate through its internal battery with duration from 30 minutes to 3 hours depending on the equipment configuration 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 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 26 PHYSIOLOGICAL EFFECTS In general the E HEART BIPHASIC DEFIBRILLATOR MONITOR doesn t offer any damage or causes any physiological effects provided that it is installed to function in an 23 US DEFIB ih kit Defibrillator Monitor E HEART appropriate medical location which it is used with the correct accessories and that it is operated by qualified staff and that all of the precautions listed in the user s manual are followed We accentuate some basic procedures of special care 26 1 ECG MODULE v v v v v The appropriate gel should be placed on the electrodes as indicated in this manual only at the moment of the use on the patient lf the electrode is pre gel do not forget to check the validity date Use perman
67. hey can be truncated or damper sinusoidal as shown below ad A Monophasic Biphasic Current Current Figure 36 Pulse wave types monophasic and biphasic Biphasic technology is safer and more effective to eliminate VF compared with Monophasic Technology as comparative table below Biphasic Technology Monophasic Technology Increased survival rate in the reversal of Decreased survival rate in the reversal of arrhythmia 96 success in the first shock arrhythmia 59 success in the first shock Less energy required 150 to 200J More energy required 360J Less time required to return to normal heart rate More time required to return to normal heart rate Minor occurrence of side effects minor burn Greater occurrence of side effects greater burn injury injury Greater effectiveness when used in cases of Minor effectiveness when used in cases of Prolonged Ventricular Fibrillation Prolonged Ventricular Fibrillation Table 6 20 US DEFIB tick in Defibrillator Monitor E HEART Energy Required Fibrillation Time Figure 44 Energy x Time 21 2 TRUNCATED EXPONENTIAL DUAL PHASE WAVEFORM V 240J 50 Ohms FASE 01 FASE 02 1550 520 520 0 10 17 20 ms Figure 37 Truncated Dual Phase Waveform 21 3 VARIATION ACCORDING TO PATIENT THORACIC IMPEDANCE IMPEDANCE A PHASE 01 B PHASE 02 25 Ohms 30 Ohms 40 Ohms 50 Ohms gt 60 Ohms The phase B c
68. hort 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 25Q to 500 and the paddles buttons are simultaneously operated lt 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 Recommendations about necessary Energy Levels for arrhythmia treatment according to Guideline 2010 of AHA for Truncate Dual Phase Technology 18 3 EXTERNAL TRANSTHORACIC CARDIOVERSION DEFIBRILLATION INDIRECT ON ADULTS Atrial Fibrillation 100J to 120J Atrial Flutter 50J Supraventricular paroxysmal tachycardia 100J Ventricular tachycardia monomorphic 100J Transthoracic External Defibrillation Indirect in adults First Defibrillation 150 J Second Defibrillation 150 to 200 J Third and subsequent Defibrillation 200 J Transthoracic External Defibrillation Indirect in children First Defibrillation 2 J Kg Subsequent Defibrillation 2 to 4 J Kg Internal Defibrillation Direct in children First Defibrillation to use the lowest energy level available with the unit about in 2J Subsequent Defibrillation 3 to 10 J Table 4 17 US DEFIB esi in Defibrillator Monitor E HEART 19 E HEART BIPHASIC DEFIBRILLATOR MONITOR CLASSIFICATION 19 1 GENERAL C
69. imultaneously with an equipment that operates in high frequency ANING 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 i ee In general the EQUIPMENT and ACCESSORIES Parts of E HEART BIPHASIC DEFIBRILLATOR MONITOR designed to be in physical contact with biological tissues cells and corporeal fluids are tested according to ISO 10993 1 guidelines and principles which deals exclusively with the test of biocompatibility of the applied parts US DEFIB a it Defibrillator Monitor E HEART TT essence lf 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 PENNE There is risk of environment pollution associated to the use of accessories and consumption materials at the end of its lifecycle 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 PATING All of the material replacement should be performed according to the specifications included in this manual US DEFIB only guarantees the equipment perfect operation if the orientations are
70. 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 lt may occur interference around the equipment marked with the following o symbol Note 1 In 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 TV transmission may not be theoretically predicted with accuracy To evaluate the electromagnetical environment due to RF fixed transmitters it is recommended an electromagnetical inspection on the location If the field intensity measured on the location that the E HEART BIPHASIC DEFIBRILLATOR MONITOR is used exceeds the conformity level used above the E HEART BIPHASIC 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 E HEART BIPHASIC DEFIBRILLA
71. ions 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 verified a possible damage to the connection cable it should be tested by specialized staff and if necessary replaced Status of the clip type electrodes and precordial 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 for ECG Other gel types as ultra sound gel and or for other aims are not indicated because they can not only introduce noises and make the exam unviable but also cause the early wearing off of the electrodes Preparation of the patient skin before fixating 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 fixation location according to the usual clinic practice hair cleaning and shaving if necessary Grounding of the power supply plug where the E HEART BIPHASIC DEFIBRILLATOR MONITOR is installed Observe the recommendations about power supply an
72. is disconnected causing capacitor discharge b Operator gt Internal battery to isolate the equipment from external electric mains gt Internal manageable battery charger with external power supply and isolation between power grid patient and operator c Aircrafts gt Low level radiation of electromagnetic fields gt High immunity for external electromagnetic fields and transients gt High mechanical resistance for vibration 13 USING E HEART BIPHASIC DEFIBRILLATOR MONITOR IN STRONG ELECTROMAGNETIC FIELDS Subways helicopters and train stations could interfere in DEFIBRILLATOR MONITOR when it is on the automatic external mode because they are composed of intense electromagnetic fields in which were observed high alterations in the sensibility and specificity Do not operate the equipment near cell phones wet surfaces high voltage lines or places near strong electromagnetic fields 14 DEFIBRILLATOR MONITOR OPERATION IN HIGH FREQUENCY ENVIRONMENT v An extreme care should be taken during surgeries that use equipment operating in high frequency especially in patients with pacemaker Besides the risk of 30 US DEFIB a it Defibrillator Monitor E HEART pacemaker damages the electric cauterization currents could cause fibrillation in the patient Always keep a defibrillator monitor nearby v Respect the minimum distance of 15 cm between ECG electrodes and the electric scalpel or defibrillator if are used at s
73. mal printer Warranty Certificate NOTE The user must observe the parameter modules that have been previously configured in his equipment 6 2 V OPTIONAL ACCESSORIES Transport case destined for transport and also safer storage of E HEART BIPHASIC DEFIBRILLATOR MONITOR Connection cable for external battery used in ambulances aircrafts or occasions where electrical energy is not available for long periods of time US DEFIB MEDICAL TECHNOLOGIES Defibrillator Monitor E HEART v Cables sensors paddles external and internal electrodes adult infantile or neonatal v Mobile trolley v Equipment support 6 3 OPTIONAL ACCESSORIES LIST Figure 3 Connection cable for external battery Figure 4 Conductive gel for ECG disposable content permanent use accessory Exclusive Figure 5 Thermal sensitive paper disposable Figure 6 Adult and Child Shock Paddles for external defibrillation and cardioversion permanent material Exclusive Figure 7 Adult Shock Paddles for internal defibrillation and cardioversion permanent use material Exclusive Figure 8 Child Shock Paddles for internal defibrillation and cardioversion permanent use material Exclusive US DEFIB ies ss Defibrillator Monitor E HEART r S Figure 9 Adult oximetry sensor permanent use Figure 11 Ear Oximetry sensor permanent use accessory Exclusive accessory Exclusive Figure 10 Pediatric
74. mmHg Table 17 Operation Atmospheric Pressure 28 1 PACEMAKER TECHNICAL SPECIFICATIONS PM Pacemaker Modes Output pulse frequency 30 to 200 ppm adjustable in steps of 1ppm Pulse width Oms to 50ms adjustable in steps of 1ms Power supply Degree of protection against electric CF Type Applied Part defibrillator proof shock Table 18 28 2 CAPNOGRAPHY TECHNICAL SPECIFICATIONS ETCO2 Parameter reading method Side stream and Mainstream Parameters frequency Yo CO2 Concentration reading range 0 to 50 mmHg Respiratory frequency reading range 0 to 35 RPM Stable condition Graphic line and numerical values O to 99 mmHg with 3 seconds N2O O2 and Deflurane Protection level against electric shock Applied part CF type defibrillator proof ALARMS Manual for maximum and minimum limits of respiratory frequency EtCO2 stable condition and CO2 inhalation Sound alarm disabled for 2 minutes Characteristics Disables audio adjust tone and 2 US DEFIB ia it Defibrillator Monitor E HEART po volume alarm delay Limits CO2 Inhalation 0 to 10 mmHg Respiratory frequency 0 to 35 RPM EtCO2 0 to 50 mmHg 28 3 INVASIVE BLOOD PRESSURE TECHNICAL SPECIFICATIONS IBP Tolerance Zero adjust Protection level against electric shock CF type applied type defibrillation proof 0 to 300 mmHg ALARMS Manual to maximum and minimum value Silent alarm Sonorous alarm disabled for 120s 5 to 75 seconds Table
75. n death and requires immediate cardiopulmonary resuscitation and defibrillation electrical shock As the place of origin these arrhythmias are classified as 25 US DEFIB aa kim Defibrillator Monitor E HEART e Atrial 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 atrial arrhythmias Figure 24 Atrial Arrhythmia Electrocardiogram e Junctional these arrhythmias occur at the junction between the atriums and ventricles e Ventricular it arises within the ventricles some with great potential to lead to death i ii i om wl 25 eea Filtro 35 Be H Md na a E om 3 me fa I i aE a F Pa A a i lt i A Bk alle ad ee Pe Pill ll ie m ll ae wl h j r F j 1 E f d i T F F i F j Pi p i A A A a A a i i Ne 7 r r 5 7 ir a S oe oa ii i F Pb oap p oa eg Bi Bilop pg gdp epea apie ee me Figure 25 Ventricular Arrhythmia Electrocardiogram 10 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 pa
76. ncy returns to a value equal or greater to that configured to avoid inhibition of abnormal T waves or extra systole The pacemaker has 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 OBSERVATION In VOO and VVI modes the pacemaker will be stimulated and transmitting information to display amplitude width frequency and mode SCS SS hS e SS e 2S ppm SCS 2S 9 Stimulation current Without connected charge 200 mA Off 0 mA Power supply 12V ECG capture through own adhesive Pads Stimulation output Adhesive electrodes PADs Frequency It is possible to adjust the stimulation frequency between 30 and 200 Amplitude The amplitude value could be adjusted between 5 and 200 mA Width It is possible to select pulse widths between 5 and 50 ms 18 US DEFIB i tint Defibrillator Monitor E HEART 8 5 2 STIMULATION SYSTEM SPECIFICATION SS hS 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 0 ms to 50 ms in steps of 1 ms Stimulation exit disposable pads ECG capture by the disposable pads Emergency VOO 70 ppm 100 mA 20 ms Protection against defibrillation discharge Up to 400 joules Other specifications may be configured as chosen by the u
77. nd more safety for operator and 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 DW MEDICAL TECHNOLOGIES CSCC fi illator Monitor E HEART Summary Warnings Symbols and Abbreviations Measurement Units Acronyms Used in this User Manual Description of E HEART Biphasic Defibrillator Monitor and Its Components 5 1 Presentation 6 Overview 6 1 Parts List and Included Accessories 6 2 Optional Accessories 6 3 Optional Accessories List 7 Parts and Commands Identification of E HEART Biphasic Defibrillator Monitor 8 E HEART Biphasic Defibrillator Monitor Characteristics 8 1 ECG Characteristics 8 2 Patient analysis system AED Mode optional 8 3 Thermal Printer Characteristics 8 4 Pulse Oximetry Characteristics 8 5 Pacemaker Technical Specification and Characteristics 6 5 1 Pacemaker Characteristics 6 5 2 Stimulation System Specification 8 6 Non Invasive Blood Pressure NIBP 8 7 Invasive Blood Pressure Module IBP 6 7 1 Functional characteristics of the IBP 8 8 Capnography Module EtCO2 6 6 1 Functional characteristics of the Capnography 8 9 ST Segment Analysis Characteristics 9 Some Cardiac Arrhythmias Characteristics 10 Impedance Indicator 11 Equipment Installation 11 1 Equipment Unpacking and Adaptation 11 2 Power Supply Battery 11 2 1 Lithium Polymer Li PO 11 3 Digital S
78. nding 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 IBP cuff and the status of the cables and connectors of the other sensors Instability and noises in the ECG trace 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 19 US DEFIB ith ac Defibrillator Monitor E HEART equipment gt Absence of conductor gel Table 14 NOTE For better information check Appendix B ATTENTION If the recommended actions are not enough to correct the problem contact the Authorized Technical Assistance by US Defib Medical Techonlogies LLC IMPORTANT Every time that you withdraw or put the fuse in do it with the equipment 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 THE DISPLAY Insufficient pressure over 30 seconds the connection tube and cuff The pressure is not high Check the placement of the Wrist pressure is smaller han 10mmHg adult Check the placement of the mode Wrist pressure is smaller O5mmHg or gt 150mmHg than SmmHg neonatal mie Placemen
79. nese study reported that the latest false positive rate and false negative was 18 times higher for computer interoretation 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 11 9 SOME CARDIAC ARRHYTHMIAS CHARACTERISTICS The arrhythmia s symptoms are quite variable and they may be silent that does not present symptoms They can be diagnosed by a physician during a cardiologic exam pulse exam and auscultation of the heart with a specific device The most common symptom is palpitation Fainting can also occur quick and spontaneous recovery with no motor abnormalities dizziness shortness of breath discomfort feeling of heaviness in the chest weakness fatigue chest pain among others Symptoms that indicate gravity are mental confusion low blood pressure chest pain and fainting If any of these symptoms occur it is necessary to perform EMERGENCY medical treatment to prevent the patient s death Cardiac arrhythmias can be classified in various ways depending on frequency formation mechanism place of origin etc We will present some terms that
80. nternal fuses to be replaced by the user All service type or future upgrades of this equipment and its US DEFIB ai kit Defibrillator Monitor E HEART parts can only be performed by trained personnel and authorized by US Defib Medical Technologies LLC Fs castes There is risk of explosion if this equipment is used in presence of flammable agents like anesthetic gases fuels among others Pi essen When the E HEART BIPHASIC DEFIBRILLATOR MONITOR is used simultaneously with an electric scalpel the orientations about equipment operation in the presence of high frequency devices indicated in this manual must be observed Lie The E HEART BIPHASIC 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 iene To prevent fire or shock risks avoid operating or fitting the DEFIBRILLATOR MONITOR near a water source also avoid spilling any liquid product on the case TT eine 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 a cardiac defibrillator discharge effects or when used s
81. oes not interfere ina possible defibrillation Normally non invasive stimulation is performed in the Apex Front or Front Back configuration Nevertheless we recommend the Front Back configuration to ease the defibrillation procedure 20 US DEFIB iti a lit Defibrillator Monitor E HEART 17 5 PACEMAKER USE INSTRUCTIONS When you turn the equipment on the pacemaker module begins a self test routine In this routine it checks high voltage circuit and output pulses parameter Amplitude Frequency and Width The pulse Pacemaker generator of E HEART BIPHASIC DEFIBRILLATOR MONITOR can be used for non invasive transthoracic stimulation application in a frequency range from 30ppm to 200ppm Tessa NON INVASIVE Pacemaker In the VOO mode the pacemaker can induce ventricular fibrillation if stimulation pulse is applied regularly on ascending portion of patient T wave A E HEART BIPHASIC DEFIBRILLATOR MONITOR Pacemaker General Description The external multi configurable pacemaker offers non invasive stimulation It could be used during cardiac surgeries as cardiac stimulator in emergencies The E HEART BIPHASIC DEFIBRILLATOR MONITOR Pacemaker is composed by a control unit based on micro controller with intelligent data transmission capacity to the 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 freq
82. orresponds to 2 3 of phase A Maximum width A B 20 ms Dead time C 0 5 ms 14 US DEFIB iti ia it Defibrillator Monitor E HEART Patient Impe dance Ohms Figure 38 Variation of waveform according to patient Impedance 21 4 VARIATION OF DELIVERED ENERGY AND DURATION OF DEFIBRILLATION PHASES PERFORMED WITH TRUNCATE DUAL PHASE WAVEFORM Table 8 Capacitor Charge 1237 Volts 150 Joules Q UE H ma Joules 60 40 60 40 7 120 80 200 60 40 100 120 80 200 60 40 1235 120 80 200 60 40 60 40 175 120 80 20 0 60 40 Table 9 Capacitor Charge 1428 Volts 200 Joules Delivered Ph 1 A Oo ms a i ane i m Joules ms 60 40 199 94 196 62 6 100 120 80 20 0 60 40 174 02 125 120 80 20 0 60 40 150 120 80 20 0 60 40 175 120 80 20 0 60 40 0 40 75 120 80 20 0 60 40 186 84 0 40 Table 10 15 US DEFIB DW MEDICAL TECHNOLOGIES OO CCC C C CSCSCSCSCSCSCSC W fi rillator Monitor E HEART Capacitor Charge 1428 Volts 240 Joules Joules 60 40 7 120 80 200 60 40 224 30 60 40 Energy in J Charge in Ohms 10 J 30 J 50 J 0 J 100 J 120 J 150 J 180 J 200 J OBS All of the data is subjected to a tolerance of 15 22 MAINTENANCE 22 1 CORRECTIVE AND PREVENTIVE MAINTENANCE 22
83. ositioning at trigger moment Connect the external adhesives paddles electrodes observing correct position after the correct paddles connection to the equipment and to the patient the ON CHARGE and TREATMENT key should be pressed to release the electric discharge to the patient 24 US DEFIB a it Defibrillator Monitor E HEART Connect the adhesive electrodes AED mode observing the correct position After the correct connection of the electrodes both to equipment and to the patient you must press the ON OFF AED and TREATMENT keys to release the electrical charge to the patient Important Observations v Do not apply shock with short circuited paddles because it could damage the trigger device v Always transport equipment with the paddles protected against dropping v There is as adaptor to use disposable paddles with the BIPHASIC E HEART DEFIBRILLATOR MONITOR 17 7 INSERTING THERMAL PAPER IN PRINTER Use appropriate thermo sensitive paper that is easily found in shops for hospital medical and surgical equipment or directly with US DEFIB MEDICAL TECHONLOGIES LLC so a sharp printing can be warranted lt should be observed that the thermal paper presents a great variation concerning sensibility and abrasion therefore it is possible to find difference in tracing tones from one manufacturer to another or different batch To introduce the paper in printer push the printer lever When the printer lid releases insert t
84. ough tone of pulse signal the alarm volumes and pulse audio indicator are adjusted independently adjustable audiovisual alarms low and high SPOs and low and high cardiac frequency bradycardia and tachycardia pulse alarm not detected low perfusion disconnected sensor key for silent alarm for 02 minutes good behavior in low perfusions The frequency detected by the equipment is between 30 and 250 ppm with a 3 precision The pulse oximetry is used in situations where the oxygen saturation SPOz is essential in anesthesia during surgeries and post surgery patients under intensive care treatment in ambulances or at home It has been proven efficient with a sample range from 70 to 100 with accuracy up to 3 The scouted saturation accuracy is undetermined when it is between 0 and 69 The oxygen saturation SPO2 is defined by the concentration rate of two main forms of blood hemoglobin the arterial hemoglobin or oxihemoglobin HbO2 and the concentration of HbO2 Hb unsaturated hemoglobin ie cHbO2 cHb The oxygen saturation is expressed in percentage and calculated by the formulae below Biolight and Nellcor Technology SPO2 cHbO2 X 100 CHbO2 cHb 8 5 PACEMAKER TECHNICAL SPECIFICATION AND CHARACTERISTICS The external pacemaker was designed to stimulate the heart in cases of rhythm disturbance and flaw to conduct internally electric pulse It is used in cardiac surgeries as emergency cardiac pacemaker Som
85. reading measurement 8 8 1 FUNCTIONAL CHARACTERISTICS OF THE CAPNOGRAPHY oe Sensors Sidestream and Mainstream type e Exhaled CO2 curve showed continuously on the screen e Auto calibration optional procedure that dismisses the specific gases use for periodic calibration Exhaled CO2 value minimum inhaled CO2 and respiratory frequency value showed continuously on the screen Miniaturized sensor with auto calibration Side stream option Mainstream or both Disposable water filter Disposable nasal line Disposable intubated line Disposable tube adaptor Respironics technology oe oe SCS SCS 2S e SCS hS e gt 2S e SCS 8 9 ST SEGMENT ANALYSIS CHARACTERISTICS The first step in order to make the analysis of the ST segment is to scan the signal for 10 seconds at a rate of 500 samples per second Eight of the derivations are of direct acquisition I Il and V1 to V6 The remaining four derivations Ill aVR aVL and aVF are derived via Einthoven s law as follows WI 1I I avr YD 2 aVL E E 2 aVF n We strongly recommend that you filter the signal in order to reject noise and achieve better results 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 i
86. rents with a superior value tend to cause muscle contractions or even burns and ventricular fibrillation Currents bellow 1 mA become imperceptible under the point of view of a shock but they can become lethal generating a cardiac arrest or ventricular fibrillation provided that a current flow in the heart of the order of 20 microamperes lt is extremely important not to let the conductive part of the electrodes transducers connectors and the own patient to be in contact with 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 cable for potential equalization should be used when other equipment are used in the same patient or operator This way it is guaranteed that all of the metallic cases are under the same potential For this connect the terminal banana plug on the E HEART BIPHASIC DEFIBRILLATOR MONITOR and the other extremity alligator plug on another equipment That should be connected to a third equipment and so on In case of cable reposition it should be the same model as the original The patient safe isolation can only be guaranteed if cables electrodes transducers are listed in the manual The adequate grounding is required as a safety measure for the patient We recommend for the installation of the E HEART BIPHASIC DEFIBRILLATOR MONITOR compliance with the requirements of t
87. rgy without drop in Ut for 5 interruptions or with a battery seconds Magnetic field in Magnetic fields in the supply the supplied frequency must be in levels that frequency 50 60 3 A m Conform are characteristic of a typical Hz according to location on a hospital environment IEC 61000 4 8 or commercial typical Note Ut is the AC supply voltage before applying the essay level Table C2 The E HEART BIPHASIC DEFIBRILLATOR MONITOR was designed to operate in any environment presented below The client or user of the E HEART BIPHASIC DEFIBRILLATOR MONITOR must assure its operation in one of those environments Interference Essay level of Conformity Electromagnetic Environment ee test ABNT NBR IEC level Orientation o 60601 Conducted RF 3 Vrms V1 V Portable and mobile RF IEC 61000 4 6 150 KHz to 80 Mhz Conform communication equipment should only be used next to any part of E US DEFIB DW MEDICAL TECHNOLOGIES CC C CSCSCSCSCSCSCSCC ef rillator Monitor _E HEART 3 V m HEART BIPHASIC Radiated IEC 80 Mhz to 2 5 Ghz E1 V m DEFIBRILLATOR MONITOR 61000 4 3 Conform including cables with a separation distance smaller than the recommended This safe distance will be calculated from the equation that is applicable to the transmitter frequency Recommended Separation Distance d 3 5 V1 VP d 3 5 V1 VP 80 MHz to 800 Mhz d 7 E1 VP 800 MHz to 2 5 GHz where P is the maximum nominal potency of the transmitter output
88. rning off the equipment if connected to a patient remove the cable from electrodes before If the patient is connected to E HEART BIPHASIC DEFIBRILLATOR MONITOR with floating isolation not connected to the power grid grounding connected to any other device that cannot have the same isolation type the patient could touch the conductive parts and cancel the equipment protection effect The connection of E HEART BIPHASIC DEFIBRILLATOR MONITOR with any other equipment is only allowed when it is not prejudicial to patient operator and ambient If the additional equipment specifications does not inform about connection effects seek for the manufacturer or expert 29 US DEFIB MEDICAL TECHNOLOGIES Defibrillator Monitor E HEART v The E HEART BIPHASIC DEFIBRILLATOR MONITOR should only be operated by qualified personnel It is the hospital administration responsibility to make available proper and accessible operation instructions v Do not shock with short circuit paddles because the trigger device could be damaged 12 1 SAFETY AND PROTECTION a Patient gt The capacitor is charged just before trigger and the charge voltage is connected to electrodes only at shock moment gt The trigger command is only enabled if capacitor is charged with selected voltage and inside trigger time 30 s Outside this period or during capacitor charging and or is detected any anomaly in the relay operation that controls the capacitor discharge
89. s 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 specific 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 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 L2 SCS SCS 2S SCS SCS 2S SCS SCS SCS This type of diagnosis must not be considered a substitute in any way for diagnosis by cardiologists because they simply are not They 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 relieves the physician from reviewing norm
90. ser SCS 2S SCS e 2S SCS SCS 2S e SS Observation The specifications above can be altered according to the user s needs A ATTENTION gt 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 gt 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 trustable gt Inthe 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 gt This equipment can only be operated by authorized technical staff gt The non invasive pacemaker is suitable for use in pre hospital or hospital environments when urgent cardiac pacemaker use is necessary 8 6 NON INVASIVE BLOOD PRESSURE NIBP This item was elaborated to make possible a simplified understanding of NIBP channel basic functions That channel provides diastolic average and systolic arterial pressure The automatic measurement time is configured by operator The Non Invasive Blood Pressure module NIBP is protected against discharges of cardiac defibrillator and it
91. sign is impossible and in C the amplifier even saturates taking a while to return to the baseline 31 APPENDIX C MANUFACTURER GUIDELINES AND DECLARATION ELECTROMAGNETIC EMISSIONS The E HEART BIPHASIC DEFIBRILLATOR MONITOR was designed to operate in any environment presented below The client or user of the E HEART BIPHASIC DEFIBRILLATOR MONITOR must assure its operation in one of those environments ELECTROMAGNETIC ENVIRONMENT MEASUREMENT ORIENTATION RF emissions The E HEART BIPHASIC DEFIBRILLATOR according to ABNT MONITOR uses RF energy exclusively for its NBR IEC CISPR 11 Group 1 internal functions So its RF emissions are very low and its not probable that they cause any interference in electronic equipment nearby RF emissions according to ABNT Class B NBR IEC CISPR 11 The E HEART BIPHASIC DEFIBRILLATOR Harmonic MONITOR is appropriate for use in all of the emissions IEC Class A residential environments and those that are directly 61000 3 3 connected to the public network of distribution of low Emissions due to voltage electricity that supplies edifications for Scintillation domestic use Tension Float IEC Coniorm 61000 3 3 Table C1 The E HEART BIPHASIC DEFIBRILLATOR MONITOR was designed to operate in any environment presented below The client or user of the E HEART BIPHASIC DEFIBRILLATOR MONITOR must assure its operation in one of those environments Interference Essay level of Conformity El
92. sories Handling 25 4 Power Supply and Grounding 26 Physiological Effects 15 16 16 16 16 17 _17 17 18 18 18 21 21 Ag 22 23 23 26 1 26 2 26 3 26 4 26 5 26 6 US DEFIB MEDICAL TECHNOLOGIES ECG Module Non Invasive Blood Pressure NIBP Oximetry Module Defibrillation Module Invasive Blood Pressure Module Capnography Module 27 Adverse Effects 28 Technical Specifications 26 1 28 2 28 3 28 4 28 5 28 6 28 7 28 8 Pacemaker Technical Specifications PM Capnography Technical Specifications EtCO2 Invasive Blood Pressure Technical Specifications IBP ECG Technical Specifications Non Invasive Blood Pressure Technical Specifications NIBP Oximetry Technical Specifications Disposable Accessories Manufacturers Permanent Accessories Manufacturers 29 APPENDIX A Fuse Replacement 29 1 Fuse change procedure 30 APPENDIX B ECG Trace Instability and Noises 30 1 30 2 30 3 30 4 30 5 The most common ECG Interferences AC Power Supply Interference Muscle Artifacts Baseline displacements Movement artifacts 31 APPENDIX C Manufacturer Guidelines and Declaration Electromagnetic Emissions 32 Technical Assistance 33 Version Control Defibrillator Monitor E HEART 24 24 24 24 23 23 23 26 27 27 28 28 29 29 30 30 3 3l 14 15 15 15 16 16 18 21 ee ae ea ee ae 24 US DEFIB esi in Defibrillator Monitor E HEART 1 W
93. ss in the presence of anemia and other diseases There are several types some extremely serious Types of Tachycardia Atrial Tachycardia it is a rapid heart rhythm that originates in the atrium e Atrial 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 e 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 e 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 Atrial Fibrillation it is an extra electrical impulses originated in the atriums that trigger rapid irregular and disorganized heartbeats e Extra Ventricular Systole it is an extra electrical impulse originated in the ventricle that promotes beat ahead of time e 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 Ventricular Fibrillation it is a fast disorganized and erratic rhythm which does not produce ventricular contraction that causes sudde
94. t oy the mode Pulse without rhythm Te not be performed cuff The measure exceeded lt measured for over 90 Only if the patient is adult 905 seconds 60 seconds for repeat the measurement do neonatal not measure again if neonatal Over 100 pulses without 100 neutral pulses any esu ware eNe Check the device configuration the device Check the device configuration cuff and repeat the operation Table 15 20 US DEFIB _ UV MEDICAL TECHNOLOGIES CSCC fi rillator Monitor _E HEART Capnography Messages THE DISPLAY DESCRIPTION ACTION Initializing Time spent by the None Capnography module to begin the measuring calibrating minute for the end of the calibration Check the flow of the These last messages Check the conditions of entry line or Check the appear when there is the tube and if flow of the outline some dirt or fold on the necessary replace the Occlusion Hit the reset tube that impedes the air filter option passage Finally reset the Capnography Table 16 25 PRECAUTIONS AND SPECIAL CARE 25 1 EQUIPMENT AND ACCESSORIES CLEANING AND DISINFECTION Do not put serum needles or objects in general on the equipment e The case cleaning and disinfection should be done with a cloth lightly moistened with demineralized water and neutral liquid soap and other soft cloth moistened with demineralized water with 2 de hypochlorite Do not use cleaning agents with abrasives or
95. t QRS complex and identifies automatically malignant arrhythmia ventricular tachycardia and ventricular fibrillation that requires defibrillation synchronism with R wave in case of QRS complex presence when on 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 offers voice and text command to instruct the rescuer during the CPR sequence THERMAL PRINTER CHARACTERISTICS High resolution thermal printer with automatic and manual registration of one channel with optional of two or three channels with the possibility of ECG registration with diagnostic quality with manual or automatic triggering after 16 US DEFIB a it Defibrillator Monitor E HEART defibrillation with annotation of date and time heart rate derivation amplitude of the ECG etc It allows manual records regardless of the defibrillation by the paddles This record is made on thermo sensitive paper of 48 mm width x 30 m length for GSI printer and 48 mm width x 20 m length for TR 50 or SP 48 printers Print speed of 12 5 25 50 mm sec 8 4 PULSE OXIMETRY CHARACTERISTICS Pulse oximetry with plethismography curve and saturation indication of numeric oxygen in percentile plethismography wave amplitude adjusted automatically on screen complete alarms system and audio and visual indication of SPOs level thr
96. t marked with NIBP and place the cuff on the patient s arm as shown below Make sure that the following marking on the cuff is placed on the arm s femoral artery and air hose must be positioned below the cuff to ensure that the hose does not become entangled enmeshed after exiting the cuff The white line on the cuff should be within the range of otherwise you will need to replace it with a more appropriate cuff smaller or larger The cuff should be placed on the same level as the heart in order to avoid false readings caused by the effects of hydrostatic of the blood column between heart and cuff lf the position of the cuff is higher than the level of the heart the reading of the ABP measured tends to be lower and if the position of the cuff is lower than the level of the heart blood pressure reading tends to be far greater 18 US DEFIB a it Defibrillator Monitor E HEART Teese The accuracy of the ABP depends on the adequacy of the cuff Select the size of the cuff according to the size of the patient s arm The cuff width should be 40 of arm circumference or 2 3 of the arm length AN WARNING You should not perform measurements of NIBP in patients in any condition in which skin is damaged or with the possibility to be damaged For a patient with thrombosis it is important to determine whether or not the measurement of blood pressure should be performed automatically The determination should be based
97. tatus of Battery Load 11 4 Transport Conditions 12 Equipment Installation and Handling Recommendations 12 1 Safety and Protection 13 Using E HEART Biphasic Defibrillator Monitor in Strong Electromagnetic Fields 14 Defibrillator Monitor Operation in High Frequency Environment 15 Care When Applying Defibrillation Cardioversion 16 Operation Mode 16 1 Equipment Configuration 16 1 1 Menu Screen 16 1 2 Setup Screen 16 1 3 ECG Setup Menu Electrocardiogram 16 1 4 Pacemaker Setup Menu 16 1 5 SPO2 Setup Menu 16 1 6 Printer Setup Menu 16 1 7 NIBP Setup Menu 16 1 8 Drugs Setup Menu 16 1 9 IBP Setup Menu 16 1 10 Configuration menu of the CAP Capnography 16 1 11 Ventilation Setup Menu 101 12 Other Functions 16 1 12 1 Pacemaker optional NS M US DEFIB 16 1 12 2 Printer optional 16 1 12 3 NIBP optional 16 1 12 4 SYNC ON 16 1 12 5 Cancel load 16 1 12 6 2 MIN 16 1 12 7 Selection Menu 16 1 12 8 Load charge 16 1 12 9 Shock Triggering 16 1 12 10 AED Mode 17 Adapting Cables and Accessories 17 1 ECG Module 17 2 SPO2 Oximetry Sensor 17 3 Adapting The Nibp Cuff 17 4 Adapting Pacemaker Paddles 17 5 Pacemaker Use Instructions 17 6 Adapting The Defibrillator Monitor Paddles 17 7 Inserting Thermal Paper in Printer 17 7 1 Instructions to Place Thermal Paper In the TR 50 or SP 48 Printer 17 8 Using Capnography and Sensors 17 9 Using the IBP Invasive Blood Pressure 17 10 Internal Battery
98. the module and equipment 25 2 STORAGE AND TRANSPORT Once you acquire the equipment make sure that it doesn t have any sign of damage Store all package materials because they can be useful in case of posterior transport o Environment temperature range from 40 to 70 C o Relative humidity range from 10 to 100 o Atmospheric pressure range from 500 hPa to 1060 hPa 525mmbHg to 795mmHg Observation US DEFIB Medical Technologies LLC does not warrant and is not responsible for any damage that occurs in the equipment that has been transported or stored in other package it should only and exclusively be transported in its original package 25 3 CABLES AND ACCESSORIES HANDLING Before putting the equipment in contact with 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 Only use accessories consumable articles and other listed in this manual US DEFIB does not warrant the equipment good operation with the use of unknown accessories besides US Defib is not be responsible for equipment operation flaws or possible damages provoked by the unknown accessories The capnography module could be damaged due to water filter reuse Follow the accessories use instructions supplies by its manufacturer The water filter must be replaced after each patient and or according to the manufacturer use instructions
99. tient The quality and integrity of the shock PADDLES The shock PADDLES contact to the patient s skin The proper connection of the shock PADDLES to the equipment It provides a rapid assessment of the patient impedance CNN NAN 26 US DEFIB i ei ti Defibrillator Monitor E HEART ATTENTION The 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 Contact ies Range Presented Color a 20 lt IMP lt 300 GOOD Bue z 3 a 11 11 1 SSS S 30 lt IMP lt 150 GREAT 150 lt IMP lt 180 REGULAR 180 lt IMP_____ BAD____ Red_ _ _ _ Table 3 Section 1 Section 2 Section 3 Section 4 Figure 26 Impedance Indicator EQUIPMENT INSTALLATION EQUIPMENT UNPACKING AND ADAPTATION Remove the equipment from package Remove the plastic protection Adapt on adequate and easy access place Install the equipment far from other equipment that generates strong magnetic fields like radiological devices and others Make sure that the installation place has an adequate ventilation and is within the pressure and temperature range indicated in this manual page 68 2 US DEFIB a it Defibrillator Monitor E HEART v This equipment was designed to operate in environments without inflammable anesthetic or cleanin
100. tion sense 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 is presented on the display with configuration items of the selected module select the item of the chosen module to be configured proceeding with same manner described previously When you select the item notice that it will blink indicating that it 31 US DEFIB ih cli Defibrillator Monitor E HEART is ready to be altered Rotate the navigation key to alter the item values increasing or decreasing them After choosing the desired value press the navigation button to hold it To exit the menu place the cursor on the item Exit with the browser button NOTE e n the modules Configuration Menu only the ones that are installed in the E HEART BIPHASIC DEFIBRILLATOR MONITOR configuration options will appear e It is possible to select the charge to be released in case of treatment 1 to 200 joules or 1 to 360 Joules according to configuration by rotating the navigation key without pressing it 16 1 1 MENU SCREEN Exit Setup ECG Ventilation Pacemaker Drugs SPO2 Capnography Printer 16 1 2 SETUP SCREEN Exit BPM Volume sync ON Key Volume Auto Charge Beep Key Paddles Selection Date Alarm Volume Time Language Exit Returns to the previous menu Alarm Vol Set the alarm volume mute 001 max 009 BPM Volume Sets the beeper volum
101. ue on the screen Informs when the capacitor is discharging CANCELED Charge automatic adjust e Allows continuous ECG registration in memory critical events and performed procedures Enables communication with microcomputer through connection for memory data visualization Optional Allows posterior reading of ECG tracing through the hardware and or software Optional Language Portuguese possibility to change language to English or Spanish optional It performs synchronized triggering with QRS complex with energy time of lt 20ms when in SYNCHRONIZED MODE Maximum time for signal stabilization 5 seconds after ideal connection of sensor on patient Full system of audible and visual alarms with the possibility of programming maximum and minimum values including besides the physiological alarms for loose electrode asystole tachycardia bradycardia fibrillation When E HEART BIPHASIC DEFIBRILLATOR MONITOR is configured in automatic mode the charge energy follows a trigger sequence of 150J 200J and 200J Pacemaker pulse detection and rejection 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 Arrhythmias analysis optional Telemetry Software optional oe e 9 SCS 2S SCS SCS oe e 2S SCS hS SCS S
102. uency and pulse width enough to execute stimulation in both Pacemaker modes through the membrane keyboard The equipment produces a sound warning that identifies in audible form the stimulation pulses B Non invasive Stimulation As a non invasive transthoracic stimulation pulse the Pacemaker of E HEART BIPHASIC DEFIBRILLATOR MONITOR delivers to patient stimulus that varies from 30 to 200 pulses per minute in asynchronous mode You can program the frequency amplitude and pulse width with the purpose to get reliable stimulation with minimum delivered energy to minimize patient disturbance The Pacemaker stimulator of E HEART BIPHASIC DEFIBRILLATOR MONITOR was designed to help during emergencies By pressing the emergency key you can turn on the VOO stimulation with the following emergency parameters gt Frequency 70 ppm pulses per minute gt Amplitude 100 mA milliamps gt Pulse width 20 ms milliseconds 21 US DEFIB ii clit Defibrillator Monitor E HEART C Applications The non invasive Pacemaker of E HEART BIPHASIC DEFIBRILLATOR MONITOR is Suitable for pre hospital and hospital environment In general it is extremely important when fast cardiac stimulation is required Some transthoracic applications when continuity is indicated are gt Symptomatic bradycardia treatment during emergency gt During and after cardiac surgery gt Toease the implantation intravenous stimulator electrode
103. waRNinc In general the EQUIPMENT Parts and ACCESSORIES of E HEART BIPHASIC DEFIBRILLATOR MONITOR destined 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 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 respected it is installed in appropriate medical place it is used with correct accessories it is operated by qualified people and that follow all precautions described in this User Manual The disposable electrodes are Single Use therefore should not be re sterilized Do not use disposable electrodes if its package is damaged 22 US DEFIB scl ito Defibrillator Monitor E HEART There is risk for patient skin burns when applying defibrillation Check the Operation Mode and other instructions on this manual 25 4 POWER SUPPLY AND GROUNDING When a medical device is connected to the power grid it may be observed the possibility of a current leakage 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 cur
104. xternal Transthoracic Pacemaker AED MODE Drug Calculation Software software for ventilation intubation mode capnography and Invasive Blood Pressure module can be incorporated into the versions of E HEART BIPHASIC DEFIBRILLATOR MONITOR Any option can be assembled at the discretion of the specific needs of each client and it does not change the characteristics of the product purpose 6 OVERVIEW US DEFIB D ON 22 wes ii OFF ls a cco ere par WANN HIL v Figure 1 E HEART BIPHASIC DEFIBRILLATOR MONITOR Front View 12 6 1 v v LYNN NNNN NNN NNN SN US DEFIB tick in Defibrillator Monitor E HEART Ao lea J eee w Figure 2 Side view with the LAP TOP 45 opening PARTS LIST AND INCLUDED ACCESSORIES 01 conductive gel tube 100 ml 01 Interchangeable and permanent external electrodes pair Shock Paddles adult infantile 01 5 way patient cable 05 Disposable electrodes 01 Adult NIBP Cuff only on the versions with NIBP 01 IBP kit only on the versions with IBP 01 CO2 kit Capnography only on the versions with Capnography 01 SpO2 Sensor configuration with SpO2 01 3 pole power supply cable 01 Grounding equalization cable 02 Replacement fuses 01 User manual 01 Set of disposable electrodes only on the versions with AED mode 01 Set of disposable electrodes only on the versions with pacemaker 01 Roll of printer thermal paper only on the versions with ther

User Manual Defibrillator MonitorE-HEART

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