Gamma Cardio CG: User Manual
Contents
1. 24 Figure 15 Peripheral electrodes positionitit 1a 26 Figure 16 Standard position of precordial electrodes 2 27 Figure 17 Precordial electrode placement on 5 2 2 21 42 1 28 Figure 18 Simultaneous display of 12 leadS i 29 Figure 19 Form for patient data ehi 30 Freare 20 Patient Data Dace ile 31 Figure 21 Example of a printed report ilari 32 Index of Tables Table 1 Composition of the Gamma Cardio CG system eene 6 Table 2 Identification of the critical electrodes cables n 17 Table 3 Connection between electrodes and the patient 25 Table 4 Standard position of chest electrodes 2 Table 5 Versions of Gamma Cardio CG 37 Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 4 Gamma Cardio CG User Manual Gamma Cardio CG User Manual Introduction Gamma Cardio CG is an Electrocardiographic diagnostic system ECG that records the standard 12 lead ECG one lead at time The system offers the high recording quality the performance and the features included in high end products with a straightforward user interface The Gamma Cardio CG system includes an acquisition unit tha2. heme Date of it 1 m becchetti claudio 14 06 1968 M Burrel John 01 01 1967 M Address roma otranto Italy De Maio Wanda Profili Pippo 01 01 1967 M Phone 39 0543 273521 D Rossi Mario 16 04 1956 184 n simulato normale M email no specific deaseses Info on Patient Drugs v bi ECG database of Mario Rossi Report recorded on 10 11 2007 i This is an essentially normal tracing 10_11_2007_h20_18_18 Rossi Mario 10 11 2007 h20 Cut x Rate 72 b m ECG Regular Sinus Rhythm PR 0 13 sec No AY Block QRS 0 1 sec No BBB QTc 0 39 sec Axis normal Range 50 degrees Dr Hans Wilson the 10 11 2007 The ECGs saved on the computer or on the network can be loaded using the button Open The system will display the usual Windows screen for opening files Note Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 31 Gamma Cardio CG User Manual that the names of the ECG files have a structure like ecg Surname Name Date Time bce where the date and time refers to the time when the ECG was recorded for example Smith_Tom_12_07_2013_h16_50_36 bce 6 4 Reporting The Gamma Cardio CG includes a module for professional printing The generated report includes the patient data the 12 lead ECG and the interpretation The following figure shows an example of such report The report can be printed sent via fax or saved in pdf format Print PreviewRossi Mario 10 11 2007 ore 20
3. Erud ca uae ane ee ee ete cee M E M as Distances Reset T Baseline A e ene Cut T2 Trace Record m Mate el ean elector ec hese M pecd mm sec mm p a Ca M i o Filter a VL a VH a VF Manual LI m Hedium 35 25 ERUIT Me n ee di Net Filter TES ig uU ET EMIT Figure 3 Detail of the main screen The main screen is divided into four areas 1 the command keyboard to control the electrocardiograph screen bottom side enclosed in the area marked with 1 Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 14 Gamma Cardio CG User Manual 2 the display area where ECG recordings are shown screen left side enclosed in the area 2 3 the toolbox area screen right side enclosed in area marked with 3 4 the advanced command area of top screen enclosed area marked with 4 4 1 Commands Keyboard bottom area of the screen The keyboard contains the command buttons usually found in the conventional electrocardiographs The keyboard layout has been designed to resemble the conventional electrocardiographs The keyboard contains the buttons controlling recording in the left panel In particular is used to automatically record a predefined number of seconds of all the ECG 12 leads The system will start recording one lead at t
4. Artefacts are mainly generated by interference from the mains supply patient muscle tremors instability of the isoelectric line 4 3 Interference from Power line When interference from the power line is significant the ECG recording contains an additional signal oscillating at a frequency of 50 times per second 50 Hertz or 60 Hertz according to the local power line frequency as shown in the example of Figure 5 Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 16 Gamma Cardio CG User Manual un m EH ada THERE EIE Figure 5 Lead V 1 with artefacts from power line The possible reasons from such interference are due to 1 high electromagnetic fields generated for example by other medical electrical equipment or neon lamps 2 high voltage electric cables close to the patient 3 poor electrode skin connection 4 faulty patient cable 5 poor connection between the electrodes and patient cable If the problem is due to the presence of voltage conductors or neon lamps such elements may be placed far from the patient area The poor electrode skin contact can be improved by hydrating skin where electrods are placed or by using conductive paste gel The conductor fault may be identified since interference completely hide the ECG signal It is recommended to replace patient cable if it is damaged To find thecritical lead connection refer to the table below and to the section 5 2 check the
5. EUR FIRE DA radere TT AEREA REA Bogen ge a eg ge anus Ga Re FON GS BT ol A HMM ee eb cb ff pn fd IE E EUER Ht XD DEED USES ea ae ae e ERU EI HI TE Mee Re Report GA 4 Ir Nl FF ee ECan Distance FAE eel den A AL HER D SERERE udo pe a EE i Filters 2 go EHE Hd p but pI ey et a sp se ete lan la et ae i ssa Figure 18 Simultaneous display of 12 leads If the isoelectric line is not sufficiently horizontal leads may overlap In this case insert the anti drift baseline filter Within this report you can also include exclude filters or change the sensitivity speed of the recording after recording The ECG waveforms will be updated accordingly This process is reversible that is no degradation is obtained in changing sensitivity speed or in changing filter configuration Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 29 Gamma Cardio CG User Manual N WARNING the 12 leads are not simultaneously recorded and therefore lea
6. area This information will be included in the report containing the ECG recording Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 30 Gamma Cardio CG User Manual N Warning press the button Save to save the ECG recording on permanent memory hard disk network storage This action will also update the internal database Without this operation the ECG will be deleted after the following ECG recording 6 2 Patient database The Gamma Cardio CG manages saved reports automatically on the database The database can be accessed by pressing Uptions 5 on the main form and clicking on the tab Patient Database The form shown in the following figure is divided into four areas After selecting a patient in the upper left area the other three areas will be completed automatically with the associated data In particular the upper right area will contain the data of the patient the lower right area will contain the ECG associated to the patient and the lower right area will contain the interpretation for the selected ECG The database is automatically updated when an ECG is saved or deleted Figure 20 Patient Database 6 3 Loading a saved ECG Patient Database General Options Report Model Generic mail Mail to Service Center Mail Options Insert Delete Modify Save Export 8 Patient x Patient A Patient Database Database gt Archive Exit Patient Database About Mario Rossi
7. caused by unintentional patient muscle activity due to 1 perceived cold environment 2 irritability 3 too narrow examination table 4 patient disease e g Parkinson s If the causes cannot be eliminated it is possible to insert the Muscle Noise Filters to 25 high effect and 35 Hertz average effect The filter at 25 Hz has a deeper noise reduction compared to the 35 Hertz Warning Muscle noise filters have the effect of rounding peaks such as the QRS complexes Consider this effect in the ECG interpretation 4 4 ECG Display The ECG display shows the ECG similarly to the physical ECG printers The top bar Figure 9 contains placeholders i e triangles that in absence of tracing are equally spaced at a distance of one second The number of beats per minute is placed between two placeholders 1 second distance corresponds to 60 beats per minute according to the formula for beat frequency calculation Beats per minutes 60 average distance in seconds between two ORS complexes Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 19 Gamma Cardio CG User Manual EE HEE E pp EEE EEE NEI ALI EEA EEA IAA CANGIA EEE Figure 9 ECG with placeholders indicating the number of beats per minute HH EE EB When an ECG is displayed pacemakers are aligned to ORS complexes This allows a quick computation of the cardiac frequency rhythm 4 5 Toolbox area This area
8. of the Software on only one product at a time Use means loading the Software in temporary memory or permanent memory in the product If you have multiple licenses for the Software you may use as many copies as you have licenses at any time The user must ensure that the number of persons using the Software installed on a network server does not exceed the number of licenses that you have Where this happens the user must purchase additional licenses until the number of licenses equals the number of users The Software is protected by copyright laws and international treaties of the EU You may make one copy of the Software solely for backup or archival purposes or transfer it to a single hard disk provided keep the original solely for backup or archival purposes You may not lease or lease the Software or copy the written materials accompanying the Software but you may permanently transfer the Software and its documentation as part of a sale or transfer of the product Gamma Cardio CG provided you retain no copies and the Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 39 Gamma Cardio CG User Manual recipient agrees to the terms of this contract Any transfer must include the most recent update and all prior versions You may not reverse engineer decompile or disassemble the Software If the package accompanying your product contains compact discs you may use only the disks appropriate for your product You may not use the disks on an
9. of the patient and operators the system has been designed with performance that are much higher than required by current standards IEC EN 60601 IEC EN 60601 1 IEC EN 60601 2 25 IEC EN 60601 1 2 Regarding the clinical validation the diagnostic performances are guaranteed through the compliance to ANSI AAMI EC 11 standard The instructions for use are outlined in the following figure Cardiologist Operator Performs Patient acquisition acquisition Performs internretation Electrodes Patient cable Figure 1 System usage The operator places the electrodes on the patient and records the ECG through the user interface available on the ECG Application Program The ECG recording is stored on computer disk or on other available media USB devices network cloud areas The ECG file can be transferred later to a qualified doctor for reporting The mail system embedded in the ECG Application Program may be also used to send ECG recording The operator that records the ECG can be a doctor a nurse and in general a properly trained user Note that the patient can record the ECG by himself through the help of other personnel for electrodes placing In this case the role of the operator coincides with the role of patient WARNING the ECG interpretation can be performed only by specialist medical doctors For rapid interpretation the specialist can use 1 the display of the ECG on the computer screen 2 the ECG
10. plug marked with pesos the label onallthe i2icads N gak on all leads except I left ankle verify the electrode the electrode has positioned on the colour if the interference is on all leads except E left wrist Yelow _ on all leads except tight wrist only a precordial precordial position No color on suction La Cx derivation V x x see section 5 3 electrodes Table 2 Identification of the critical electrodes cables If artefacts cannot be eliminated insert the net filter by pressing the corresponding button pi Net Filter This operation can also be performed after recording For example activating the line filter on the ECG of Figure 5 will eliminate interference showing the ECG tracing as in the following figure Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 17 Gamma Cardio CG User Manual Figure 6 Lead V 1 with artefacts from mains supply figure 5 and net filter activated 4 3 1 Isoelectric Line Instability The isoelectric line is the straight line obtained in absence of electrical activity This line should be horizontal During recording the ECG waveform moves cyclically with respect to the isoelectric line due to the electrical activity of the hearth When interference is on the isoelectric line the ECG waveform will have a non regular trend that is not parallel to the horizontal axis as shown in the examples of the following figure popup EEE
11. printed on paper Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 10 Gamma Cardio CG User Manual 3 the ECG sent by fax The operator can send the recording to a specialist through the fax printing function of the ECG Application Program when the PC is connected to a PSIN line and the computer has the fax application properly installed 4 the display of the ECG file received by e mail stored on removable media or on network cloud drive The ECG Application Program allows sending ECG recording via e mail and or it can store the recording into a media such as USB pen drive hard disk CD ROM storage area network The ECG can be stored in a standard format Acrobat PDF or in the Gamma Cardio Soft proprietary format To show ECG recording specialists require a PC containing Acrobat Reader freely available on Internet to display the standard format PDF or The ECG Application Program to display the proprietary format With the Gamma Cardio Soft ECG Application Program the specialist or the operator has the possibility apply or remove filters to eliminate artefacts or to delete parts of the ECG even after recording have been performed The specialist can also use special diagnostic tools for rapid interpretation included in the program The specialist can save the ECG with interpretation in the patient archive included in the ECG Application Program It is possible to send ECG and the associated interpretation via fa
12. the menu programs and locate the menu Gamma Cardio CG where the program The installation program places the icon on the desktop and the menu Gamma Gamma Cardio CG can be started Gamma Cardio Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 13 Gamma Cardio CG User Manual 4 Key Features To access the main features simply press the associated buttons available on screen of the ECG Application Program These buttons have similar appearance and behavior to the buttons present in the ECG physical devices To select the functions associated to the buttons 1 place the mouse arrow on the button to be selected 2 the arrow will turn into a virtual hand i and the button will be selected the button color will become lighter 3 press the left mouse button to push the selected button function For computers with touch screen simply use the finger to select the required function The features are grouped spatially in a consistent manner as shown in the following figure Ae Print com oe Send Fax Help i 5 beats minute ECG NOT CONNECTED Step by step Interpretation Step by step Recording EE AAT ae eee ee ET DOSE ODDS EDT DEDE D IDEE um HE EA GE GEE EE E EE DEED EDU
13. 18 18 Zoom po oom e Fe Save Print Close Full DP e S Width E a P e on Ge in TE Send Far Fatient Mario Rossi Date of Birth 16 04 1956 Comments HEREIN ERI dE usd pum at tr a M T Hp HEINE Hu PHME UU Dag ERE ERES UE nune UU EE 77 17 7 HECUUIEHEHERESI CDU EUH OE SUUM EE MEHR EE EE EFFE mui E 22 uli 1 d o o o D ee GRA ad nme faa tl ES pe A ES ST EET HEEE eee eee ee ae ROCA Page 1 1 Figure 21 Example of a printed report 6 5 Usage with defibrillator The Gamma Cardio CG system is protected by defibrillator discharges provided that the supplied cable or a cable approved by Gamma Cardio Soft is used At this aim it is recommended 1 to follow the instructions of the defibrillator 2 to place the defibrillator paddles in areas well separat
14. E p uu por EE See Eg muni Figure 7 ECG with instability of the isoelectric line These artefacts are generally caused by 1 inadequate connection between the cable and the electrode or between the electrode and the skin 2 polarization of the electrodes especially at the beginning of the ECG tracing 3 movements of the patient In case 1 check for possible critical connections on patient cabling referring to Table 2 If necessary repeat the procedure for the electrode displacement moistening and rubbing the skin contact area In the other two cases the problem is usually limited to a specific area of the ECG and therefore after recording it is possible to delete the unsuitable ECG parts affected by artefacts using the button re During recording if the ECG is slowly approaching to the horizontal isoelectric line as in the right part of the previous figure it is possible to quickly restore the horizontal behaviour by of pushing the button giu Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 18 Gamma Cardio CG User Manual When the problem cannot be eliminated the Net filter may greatly reduce the artefact button NetFilter 4 3 2 Muscle tremor The EGC recording affected by noise due to muscle tremors appears as in the figure below Aa Aa ie Ne 22 2 Figure 8 ECG with artefacts due to muscle tremors The ECG shows a behaviour that resembles the classic saw tooth pattern Muscle tremor is
15. Gamma Cardio Soft Gamma Cardio CG ECG Multifunctional System User Manual Revision 1 22 14 02 2013 Gamma Cardio CG User Manual Gamma Cardio Soft Srl via Felice Cascione 10 00128 Rome www GammaCardioSoft it Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx Introduction 92 IN Gamma Cardio CG User Manual Table of Contents O5 191 How to use this manual General Warnings N 11 Operating Environment 8 1 2 Connecting Unit to the PC 8 1 3 Before use 9 Intended Use 9 Installation 12 3 1 Minimum Computer Requirements 12 3 2 Installation procedure 12 3 2 1 Connecting the unit to the computer 13 3 9 Running the ECG Application Program 13 Key Features 14 41 Commands Keyboard bottom area of the screen 15 4 2 Noise reduction and artefacts 16 4 3 Interference from Power line 16 4 3 1 Isoelectric Line Instability 18 4 3 2 Muscle tremor 19 44 ECG Display 19 4 5 Toolbox area 20 4 5 Deleting ECG parts 20 4 5 2 Deleting leads from the PC memory 20 4 5 3 Record a new ECG 20 4 5 4 Measurement of intervals 21 First use 22 5 1 Preparing the ECG system 23 5 2 Connecting the electrodes to the patient cable 25 5 9 Electrodes placement 25 5 4 recording 28 5 4 1 Reducing artefacts 28 Additional Features 29 6 1 Entering patient data 30 6 2 Patient database 31 6 3 Loading a saved ECG 31 6 4 Reporting 92 6 5 Usage with defibrillator 32 6 6 Other features 33 Maintenance 33 7 1 Warranty and Disclaim
16. al v7 17 Mar 2014 EN docx 36 Gamma Cardio CG User Manual Medical device class IIB Safety Rules IEC EN 60601 IEC EN 60601 1 IEC EN 60601 2 25 Electromagnetic compatibility EN 60601 1 2 Class I IEC EN 601 1 Class IIb 93 42 EEC standards The technical characteristics and the figures shown in this publication are subject to change for updates in the used technology in software or in changed requirements 8 8 Versions The Gamma Cardio CG is sold in the following versions Version Special features Base Patient Specific version for trained patients Extended Contains additional features see previous paragraphs Multichannel Allows the simultaneous acquisition of all channels Table 5 Versions of Gamma Cardio CG The acquisition unit can be connected to the PC through the USB port or serial port 8 9 Electro Magnetic Compatibility Tables The following table shows the EMC emission and immunity performances according to Article 6 of EN 60601 1 2 Such performances are based on evidences and tests Aspects of emission Equipment in which there is intentionally generated or used conductively coupled RF energy that is necessary for the internal functioning of the equipment itself Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Group 1 CISPR 11 Equipment suitable for use in all domestic establishments and t
17. as been used according to the instructions for the twelve months following its first purchase To this end the date indicated on the original invoice or receipt will be considered Any use out of the specified intended use and or any bad or incorrect use of the product will make any warranty not applicable Where applicable failure to comply with any general and or particular warning invalidate warranty automatically Gamma Cardio Soft Srl does not guarantee that the Gamma Cardio CG meets the needs and expectations of the purchaser and it does not assume any responsibility for any direct or indirect damage caused by the installation of software improper use of the system or errors inherent in the program and or in the system even in the case where the company had had prior knowledge that such damage could occur The buyer is then responsible for the selection installation of software and the use of the system and the results obtained All service must be performed only by authorized personnel of the Gamma Cardio Soft Srl and with original spare parts Repairs carried out by unauthorized personnel and or when spare parts are not original this is a reason to make any warranty not applicable Gamma Cardio Soft Srl is not liable and cannot under any circumstances be held liable for errors and or misuse of the product and the resulting accidents Within the limits established by Italian law Gamma Soft Cardio Srl shall not under any circumstan
18. bility of changing the parameters of sensitivity and speed in real time or stored on the track with no degradation in quality 5 10 25 50 mm second 75 100 200 mm second zoom recording speed 5 10 20 mm mv 30 40 50 mm mv zoom recording Recording Speed zoom Sensitivity zoom Pacemaker display performance according to the standard AAMI 11 The scissor tool allows the elimination of non significant ECG segments Pacemaker Scissor tool Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 35 Gamma Cardio CG User Manual 8 5 Reporting tool Feature Performance The ruler tool is used to calculate horizontal and vertical distances between two points on reporting the results in millimetres milliseconds and millivolts beats per minute The system automatically displays the distance in seconds between two ORS complexes and the instantaneous ventricular frequency beats per second Ruler tool calculating distances between two points of the ECG Automatic calculation of the frequency System for calculation of parameters of the ECG Expert system query for System that identify set of conditions given the parameters of the reporting ECG Extended Version Extended Version 8 6 Electrical Specifications Acquisition Unit Electrical Specifications Performance In real time in manual mode one channel at a time ECG Acquisition in automatic acquisition of 12 lead ECG in sequence single channel v
19. ces and in any way be recognized responsible for any damage whether direct incidental consequential exemplary or punitive damages for loss of business profits business interruption of activity loss of information or other pecuniary loss due to the purchaser of the product or the subject on which it is used in operational use or inability to use the product In any case the responsibility of Gamma Cardio Soft Srl will be limited to an amount corresponding to the price actually paid for the Gamma Cardio CG Gamma Cardio Soft Srl expressly declares that the Gamma Cardio CG should be used only by qualified personnel in the use of electrocardiographic equipment Gamma Cardio Soft Srl moreover expressly declares that only qualified personnel can perform ECG interpretation and the diagnosis of cardiac diseases Gamma Cardio Soft Srl warns buyers that interpretation of the ECG by unskilled personnel constitutes a serious potential danger to the health of patients Always be informed and respect local medical regulation Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 34 Gamma Cardio CG User Manual 8 Technical Specifications Gamma Cardio CG is a system for diagnostic electrocardiography able to record the standard 12 lead ECG one lead at a time The following are the main performances 8 1 Database Feature Performance Ecg records and reports Automatic storage of medical reports and ECG records Automatic storage of patient data an
20. contact with the previously moistened skin areas The following figure shows the position of the limb electrodes based on their color F cad 1 Black Right Ankle Figure 15 Peripheral electrodes positioning The standard positions of the suction electrodes precordial are summarized in the following table Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 26 Gamma Cardio CG User Manual Code of the terminal PENY Derivation electrode Position the patient European IEC standard 4th left intercostal space at the right parasternal line name USA Table 4 Standard position of chest electrodes m V3 4 l 5 The next figure shows the electrode placement in more detail co a P N 79 97 Figure 16 Standard position of precordial electrodes For a faster positioning of precordial electrodes consider the following indications e and C2 to the right and left of the sternum about 3 cm above the sternum xiphoid process IV intercostal space oth left intercostal space at the mid clavicular line e 8 at the midway point between C2 and C4 on the same horizontal level of C4 fifth intercostal space but respectively on the front and the left axillary line on the line media Note however that the ECG recording is unaffected by millimetric errors in positioning the electrodes The next figure shows the placement of the electrodes
21. contains tools for 1 deleting parts of the recording 2 measuring distances 3 measuring current heart frequency rate When the Gamma Cardio CG system recognizes the ORS complexes average heart frequency rate is displayed with a blinking heart symbol synchronized with hearth systoles 4 5 1 Deleting ECG parts To delete ECG segments within a derivation 1 place mouse pointer over the starting point of the section to be deleted 2 hold down the left mouse button and drag the mouse to the end point of the section to be deleted 3 release the mouse button and press the button P N WARNING It is recommended to remove only segments including complete beats for example from the beginning of a P wave to the beginning of the following P wave of the next beats so as not to introduce discontinuities in ECG recording or artificial artefacts 4 5 2 Deleting leads from the PC memory To delete the selected lead or all the recorded leads not yet saved on disk press the button Cut without selecting any ECG segment The ECG Application Program will Trace show a window with options for deleting recorded leads in memory Note that this procedure does not delete leads saved in disks 4 5 3 Record a new ECG When the button is pressed the eventual ECG stored in memory is deleted and a new ECG 1s recorded Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 20 Gamma Cardio CG User Manual Trace The ECG stored in memory may be de
22. d fast retrieval of the Electronic Health Record associated ECG and reports 8 2 Telemedicine functions Feature Performance Embedded integrated E mail capability with fast delivery to address book recipients or telemedicine centres ECGs and reports can be transmitted via Printer or Fax A PC including a modem card Fax and a fax printer is required Assisted step by step Tools for assisted rapid ECG interpretation frequency rhythm interpretation capability axis assisted measuring Assisted step by step fast Step by step driven procedure for rapid ECG recording suitable recording capability for less experienced operators 8 3 Reporting Feature Performance Professional report module that can be saved in proprietary or standard Acrobat PDF format Print preview with zooming capability X 2 X 3 and printing of ECG in high quality on plain paper A4 size Report Format Print Preview 8 4 ECG Display Performance Filters in real time and in post Possibility of activating deactivating filters in real time mode or acquisition after the recording without degradation of the ECG Filters Baseline filters Net filter Muscle Noise filter at 25 and 35 Hz Automatic recovery of isoelectric line in the presence of high artefacts or defibrillator discharge Manual recovery button is also available Automatic recovery of isoelectric line Sensitivity and speed of the track in real time and in post acquisition Possi
23. ds are related to different time instants For this reason the ORS complexes of different leads are not aligned Consider this circumstance when interpreting the ECG 6 1 Entering patient data Before saving ECG on the hard disk or on the network it is suggested to enter patient data In this way the saved ECGs of a specific patient will be easily retrieved To enter patient data 1 Press the button as e available after pressing Analyze kety 2 Enter data into the form shown in the following figure Report Burrel John 12 06 2005 Patent information printed on the report Data for the Patient Folder Address Telephone Height Patent Information Surname Burrel Mame John Id Code SexF Mf Bithda 11 01 1967 47 anni Weight 180 Additional Mates routine exam Report This is an essentially normal tracing Rate 2 bem Regular Sinus Rhethm 013 sec No amp V Block HRS 01 sec BBB OTe 0 39 sec Awe normal Range 50 degrees Hypertrophy Ho Infarction Data 16 07 2005 Dr Print Model Exit I Save LJ Figure 19 Form for patient data entry N WARNING The ECG interpretation must be completed by qualified personnel If the interpretation is performed after recording as in the case of a telemedicine scenario it is suggested to include all relevant data for interpretation health motivation examination in the Additional Notes
24. e refer to the section 7 1 Warranty and Disclaimer The acquisition unit shall be placed and used on a flat stable surface away from heat sources and areas with risks of potential fire The system shall not be used in its packaging The acquisition unit must be placed far from objects experiencing easy combustion Special attention should be considered in storage separating the device from clothing sheets and anything that may generate possible fire The eventual conductive gel used to improve electric conductivity must be suitable for ECG examinations The supplied materials should be used only for functions for which they were designed built and sold including the packaging and this manual The equipment must be used in the environmental conditions of temperature and humidity specified in this Manual The Manual describes also how to maintain equipment efficiently In case of storage the device shall be placed in environments with low humidity and temperature see operating and storage conditions The device should be used at environment pressure and natural air Do not use the unit in presence of gases or flammable vapours or in oxygen rooms even for a limited time The device is supplied with an enclosure completely closed but not sealed accidental drops of liquid on the casing can seriously damage the unit The electrodes cables and other accessories must be cleaned thoroughly after each use also to avoid infections and or contam
25. ed from the ECG electrodes Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 32 Gamma Cardio CG User Manual 3 not to touch the body of the patient during defibrillation The Gamma Cardio CG System will restore the ECG waveform few seconds after defibrillator wh Reset discharge To restore the isoelectric line more quickly press 6 6 Other features The Gamma Cardio Soft system allows also e sending the ECG to an ECG Interpretation Services Centre and or to Doctors cardiologists using the integrated email system e printing professional reports e saving the ECG in Acrobat PDF format e sending the ECG via fax e the automatic storing of reports in the database These functions are available through the buttons on the advanced features placed in the right area of the form shown in Figure 17 or in the top area of advanced commands of Figure 3 For the use of an external e mail management program it is necessary that the computer is equipped with an e mail application compliant to the standard MAPI Microsoft Windows Outlook Express Lotus Notes and that there is the availability of an Internet connection The fax function can be used if the PC is equipped with a Fax modem card and the fax printer application is installed 7 Maintenance The Gamma Cardio CG does not require special maintenance operations Refer to the instructions of the electrodes and the cable for the specific maintenance For assistance re
26. er 34 Technical Specifications 35 8 1 Database 35 Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 8 2 Telemedicine functions 35 8 3 Reporting 35 8 4 ECG Dlsplay 35 8 5 Reporting tool 36 8 6 Electrical Specifications Acquisition Unit 36 8 7 Additional Features 36 8 8 Versions 37 8 9 Electro Magnetic Compatibility Tables 37 9 Copyright Notice 39 91 Software License Agreement 39 Index of Figures Figure liceo 10 Figure 2 Connect the USB cable to the acquisition 1 13 Figure 3 Detail Of the Main SCLC CI ucraini 14 Figure 4 Lead Selector Panel 16 Figure 5 Lead V 1 with artefacts from power line eere 17 Figure 6 Lead V 1 with artefacts from mains supply figure 5 and net filter activated 18 Figure 7 ECG with instability of the isoelectric 2 2 2 2 2 18 Figure 8 ECG with artefacts due to muscle tremors eene 19 Figure 9 ECG with placeholders indicating the number of beats per minute 20 Figure 10 Tool for measuring distances i 21 Figure 11 Gamma Cardio CG Ge 6 Css crested ehe anette 22 Figure 12 Step by step Recording procedure 23 Figure 15 Mam application WIdo Wool 24 Figure 14 Connection between patient cable and acquisition unit
27. ersion Frequency input signal 0 05 to 150 Hz AAMI EC 11 Leads Standard 12 lead ECG AAMI EC 11 Horizontal Resolution 0 83 milliseconds acquisition 1200 samples second Vertical resolution amplitude 2 5 microvolt in acquisition Dynamic Range 5 millivolts AAMI EC11 Accuracy overall error lt t 5 AAMI EC11 Maximum potential bias on the 300 millivolts AAMI EC11 electrodes Time Constant lt 3 2 sec AAMI EC11 Input Impedance gt 20M Q AAMI EC11 CMRR gt 100 dB Leakage current in the patient Much lower than maximum limit 10 u A Patient Input Type CF isolated with protection against defibrillator discharge Calibration Calibration function with step 1 millivolt 8 7 Additional Features Performance Built in test that allows detecting faults in the acquisition unit at module level terminals standard 12 lead patient cable Electrodes four clip electrodes and six precordial electrodes with suction cups Included Accessories cable to connect PC to Acquisition Unit USB 2 0 A Male to B Male Cable user manual e CD with the ECG Application program Weight 170 grams without the patient cable and the USB Dimensions 9 x 15 x 2 Acquisition unit SEPT Power from the USB port no need for batteries or transformers connected to the mains Connection to the PC USB port Environmental conditions Operating 5 C to 40 C humidity 25 to 95 Gamma Cardio CG User Manu
28. fer to Gamma Cardio Soft Srl Rome Italy www GammaCardioSoft it The cleaning of the patient cables must only be carried out with the product disconnected The use of a cloth moistened with suitable detergent solutions non ionic surface active and disinfectant solutions 0 1 0 2 quaternary ammonia based components is recommended After cleaning use a cloth moistened with water in order to remove all detergent residues Dry well the electrodes before use Do not immerse the power cord and Gamma Cardio Soft acquisition unit in liquid solutions The electrodes can be washed with detergents and disinfectants suitable for surgical instruments After cleaning rinse with clean water and dry Do not use ultrasonic baths for cleaning the electrodes The Gamma Cardio Soft acquisition unit can be cleaned with a cloth moistened with water and then dried with care Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 33 Gamma Cardio CG User Manual Warning for environmental protection In the European Union this label indicates that this product must not be disposed of with household waste The device should be disposed in an appropriate plant that is able to perform operations for recovery and recycling Please protect the environment deliver this device to a specialized centre at the end of life 7 1 Warranty and Disclaimer Gamma Cardio Soft guarantees that the product will be free from production defects if and only if the product h
29. for an adult Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 27 Gamma Cardio CG User Manual FAV Figure 17 Precordial electrode placement on adults To apply the precordial electrodes hold the suction cup squeeze the rubber ball and then press the electrode until a good adherence of the contour of the cup on the skin is obtained Then release the rubber ball A bad contact between the electrode and skin introduces artifacts as shown in section 4 2 In case of excessive hair in the chest area the use of a conductive paste gel may help improving conductivity between the electrode and the skin In the most critical cases chest area has to be shaved 5 4 ECG recording The automatic mode may be used to quickly record a new ECG press the button sonate and wait until all the 12 leads are recorded It is suggested not to activate noise filters during recording to avoid that the ECG signal slow down on the display for computers with limited performance The anti interference filters can also be activated after ECG has been recorded When recording only the peripheral leads I II III aVL aVR aVF automatic recording can be stopped by pressing BEES 5 4 1 Reducing artefacts Make sure that ECG recording does not include significant artifact as described in paragraph 4 2 Noise reduction and artefacts To do this use the lead selector panel to display all the leads It is recommended to repeat recordin
30. fy the information contained in this publication without prior notice Refer to the online user manual available in the ECG Application Program for the latest updates 9 1 Software License Agreement The Gamma Cardio CG System is protected by copyright laws by the laws on copyright and industrial inventions and by the provisions of international treaties This document is a legal contract in effect between the user and the Gamma Cardio Soft Srl This agreement covers all software that is distributed with the product Gamma Cardio CG with the exception of components that are distributed with specific licensing agreements see Gammacardiosoft_copyright txt file included in the installation CD This agreement is not for the purpose of sale of the Software or any other intellectual property All title and intellectual property rights in the Software thereto are the property of the holder and owner of the Software Any rights not expressly granted under this Agreement are reserved to the manufacturer or the owner of the Software By opening or breaking the seal on the Software packet installing or downloading the Software or using the Software that has been preloaded or is embedded in the product you agree to be bound by the terms of this contract If you do not accept such terms you must return within 7 days of purchase all items of the Software disks written materials and packaging and delete any preloaded or embedded Software You may use one copy
31. g for leads including significant artifacts by using the manual mode button Manual Follow the procedures in section 4 2 to eliminate artifacts improving skin electrode and verifying electrode cable connections and check the effectiveness of these procedures on ECG recording quality Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 28 Gamma Cardio CG User Manual Press the Stop button at the end of the manual recording If artifacts are located in a limited area the cut trace button Cut may be used to eliminated selected areas of Trace recording If the causes of artifacts cannot be eliminated insert anti interference filters 6 Additional Features button All the twelve leads can be shown using the Analyze keg This button will show a report where ECG quality can be verified as shown in the following figure i ECG Analysis Burrel John 12 06 2005 JE i LL EG un m E EE fia EE EE ETE Ee DEREN G Tools Filters Sensitivity Speed Close Close g Print ae id IL TL et Ty Te Hei erste onda SVE UE ee ee an EN E ne aH nT au ee AE av gee eae eR aE EE ADE GEG GET NONA Ed ae AGO GEO EERE VUE
32. hall not undergo sterilization processes AN The system has leakage currents in the patient that are more limited than the maximum allowed by current safety standards IEC 60601 However if you simultaneously connect multiple devices to the patient the sum of the leakage currents may exceed the allowed limit There are no risks associated with the use of this device with pacemakers Note that the ECG trace may appear later Disable filters to reduce this delay 1 2 Connecting Unit to the PC The system has been built in compliance with current regulations on medical devices i e Medical Device Directive The acquisition unit electrically isolates the patient from the computer with a double insulation indicated with the symbol unit has been designed to achieve the maximum safety level of electrical insulation CF parts applied to the patient symbol 489 this is the highest safety performance level that may be achieved by an ECG Note that some computers and in particular the majority of portable computers do not have metal parts which can be touched by the user and therefore they are equipped with plug without earth connection plug with two poles These computers do not require additional specific measures when used in medical environments If your computer is equipped with metal parts accessible to the user the plug has a third terminal for grounding three prong plug If regulatory requirements are not attended for exa
33. he acquisition unit to the PC before installing the ECG Application Program unplug the unit and wait a few minutes and then proceed with the insertion of the CD After a few seconds the computer will display the installation program If you don t have a CD reader on the specific PC copy all the CD on an USB network drive If the installation program does not run automatically or if software is not on CD 1 Click on My Computer 2 double click the icon for the CD Rom the drive where the software is located 3 double click on the file Setup_GammaCardioCG exe Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 12 Gamma Cardio CG User Manual Follow the installation instructions that appear on the screen When prompted connect the acquisition unit to the computer as follows 3 2 1 Connecting the unit to the computer Connect the small connector of the USB cable left part of Figure 2 to the acquisition unit a Figure 2 Connect the USB cable to the acquisition unit Connect the large connector with rectangular section to an USB port on your computer 3 3 Running the ECG Application Program Cardio CG among the applications recallable from the start button if applicable for the specific operating system To start the ECG Application Program double click on the desktop icon or start the program by pressing the button ULM For older Windows operating systems select
34. hose directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emissions CISPR 11 Aspects of immunity The product is intended for use in the electromagnetic environment specified below The customer or the user should ensure that the product is used in the specified environment Test level Immunity Test IEC EN 60601 1 2 Electrostatic refer EDI Floors should be wood concrete or ceramic tile discharge ee 8KV inair if floors are covered with synthetic material the IEC EN 61000 4 2 relative humidity should be at least 30 Electrical fast transient burst 1 kV signal lines IEC EN 61000 4 4 Level of Electromagnetic Compliance environment guide 2 lines The quality of the mains voltage should be that signal supply of a typical commercial or hospital environment Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 37 Gamma Cardio CG User Manual Magnetic field Magnetic fields at mains frequency should be at values of a typical area in a commercial or IEC EN 61000 4 8 hospital environment Aspects of immunity to RF The ECG product is intended for use in the electromagnetic environment specified below The customer or the user should ensure that the device is used in such an environment Test level to Immunity test EN 60601 1 2 3 Vims from 3 Vims from The RF communications equipment portable and mobile 150kHzto 150kHz to should not be used near t
35. in the lead selector panel shows that the corresponding lead has been recorded in memory For example in Figure 4 leads I II and II have been already recorded The arrow buttons for the Sensitivity and Speed Figure 3 bottom right allow for changing speed and sensitivity as in the conventional electrocardiographs with the difference that sensitivity and speed can be changed also when the lead has been already recorded The arrows buttons of speed increase or decrease the scrolling speed of the ECG pen as in conventional ECG devices This allows having horizontally enlarged or shortened ECG traces Similarly the sensitivity buttons allow you to change the vertical scale of the ECG recording The system presets the standard speed and sensitivity sensitivity 10 mm mv and speed 25 mm sec Double clicking on the speed sensitivity indications will revert to the standard values Available recording speed are 5 10 25 50 mm second 75 100 200 mm second zoom recording speed Available Sensitivity values are 5 10 20 mm mv 30 40 50 mm mv zoom recording sensitivity It is worth noticing that sensitivity and speed can be changed also after recording Using this capability it is possible to show enlarged details of the ECG morphology display many consecutive waves for evaluating rate and regularity of heartbeats 4 2 Noise reduction and artefacts The noise filters allow reducing artefacts superimposed to the ECG tracing
36. ination of the patient and or user The cables should also be cleaned as indicated by cable user manual Before each use the user must ensure that the usage environment meets the given specifications The ECG device should be placed and used at suitable distance from the equipment for monitoring clinical parameters and devices particularly sensitive to electromagnetic radiations The ECG device must be used in an electromagnetic environment as specified in section 8 9 Electro Magnetic Compatibility Tables Before each use the user must ensure that the ECG system works properly in its hardware and software components The hardware and or software functions may not be continuous and also have errors due to the specific characteristics of the computer A When ECG recording is not performed directly by cardiologists personnel shall carefully read section on electrodes placement Chapter 5 and expressly inform cardiologist that electrodes have been placed by personnel with limited experience if applicable Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 7 Gamma Cardio CG User Manual 1 1 Operating Environment AN WARNING the system js not intended for use in the presence of flammable anaesthetic mixtures or in environments with explosion hazards isnot protected against the penetration of water js not to be installed in adverse environments high humidity direct sunlight and continuous presence of excessive dust sulphur s
37. isition unit m The End user and maintenance manual Table 1 Composition of the Gamma Cardio CG system For product effective usage we recommend reading the Chapter 1 General Information concerning protective measures Chapter 2 Intended use describes the system features Before connecting the unit to the acquisition computer it is recommended that you read Chapter 3 explaining how to install the ECG Application Program Chapter 4 Main Features illustrates the ECG Application Program usage In Chapter 5 First use the user will find a detailed description of recording procedures and electrodes positioning More experienced users can refer to Figure 11 for a summary of the main features available in the system Advanced features reporting printing e mail archive patient are described in Chapter 6 Additional Features Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 6 Gamma Cardio CG User Manual 1 General Warnings A Please read carefully the instructions and the following warnings This section contains general warnings on the proper use of the device Other special warnings are contained in the following paragraphs Failure to comply with any of the specified warnings will automatically invalidate warranty if applicable The manufacturer has no responsibility for damages direct or indirect resulting from non compliance with General warnings or other warnings included in this manual For additional details pleas
38. leted pressing the button and selecting the option new ECG included in the window that is displayed 4 5 4 Measurement of intervals To measure the horizontal and vertical distance between two points 1 press the button 2 place the mouse pointer on the starting point and click with the left mouse button 3 place the mouse cursor on the second point and click with the left button Compute Distances The window of Figure 10 will appear indicating the vertical distance in millimeters and millivolts and the horizontal distance in millimeters seconds and in beats per minute between the two selected points poet e ET DO ME ESO rund uu E EET ni H pp o NEU Ud pes d SEA acl ds 0 84 i eme beats minute 71 4 euo po Eod Mew Measure Close Window cEBEBEBENP NNI Figure 10 Tool for measuring distances Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 21 Gamma Cardio CG User Manual 5 First use The following figure shows the steps required to use the ECG system Prepare Computer and ECG Acquisition Unit Connect the electrodes to the patient cable Place electrodes on patient Record ECG leads Insert biodata Interpret ECG of patient save on PC Print ECG send ECG send ECG Generate a report in via e mail via Fax Acrobat amp PDF Send ECG to an Send ECG ECG service center to a doctor Figure 11 Gamma Cardi
39. mple because room grounding system is not compliant in case of specific failures the patient could receive a shock by touching the metal case of your PC Such an event is independent from the use of the Gamma Cardio Soft ECG Never use any medical device in environments where grounding is not compliant with local regulations A To avoid problems computers with power plug including earth connection three prong plug shall always be connected to a power outlet with a protective grounding compliant to local regulations Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 8 Gamma Cardio CG User Manual If these PC are being used in medical area three options are suitable to comply to EN 60601 1 regardless the use of the Gamma Cardio CG product 1 PCs shall be placed outside of the patient area i e so that the patient can not touch them directly or through other persons or 2 the PC shall be connected to ground with a permanent cable that may be detached only with the use of a tool EN 60601 1 1 BBB 201 1b or 3 the PC shall be connected to an outlet with additional isolating transformer In any case the computer shall meet the safety standards relating to information technology equipment EN 60950 and any applicable regulation Warning The system is protected against defibrillator discharge only when used with the supplied cable In case of damages of the patient cable use an equivalent patient cable or a cable type ap
40. o CG usage The following paragraphs describe the steps outlined in the previous figure For a fast acquisition you can use the step by step procedure that simplify ECG recording Step by step Push the Recording button on right side of the main screen window The following frame will appear Perform each step in order to finalize an ECG recording Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 22 Gamma Cardio CG User Manual Record ECG step by Step procedure 1 Record New ECG 2 Prepare Patient D 3 Record ECG 4 Input cx Patient Data Ji 5 Show all lead records b Save record Lt 7 Send ECG for Send Mail Print lt gt Figure 12 Step by step Recording procedure 5 1 Preparing the ECG system To record an ECG do the following before placing the electrodes on the patient switch on the computer al run the ECG Application Program using the icon 78 3 d T c after few seconds the ECG Application Program window shown below will appear on the screen Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 23 Gamma Cardio CG User Manual Gamma Cardio CG Station Gamma Cardio Soft S r l All Right Reserved o t ZS T GU m Options Help 60 Vv 60 apre beats minute _ECG NOT CONNECTED i Step by step Interpretation i di Ss SESE ESTES f Step by sep Hou ppp p p pu pu pp ec
41. o any part of the ECG including 80 MHz 80 MHz cables except for equipment that complies with the recommended separation distances calculated according to the equation applicable for the transmitter frequency Level of Electromagnetic compliance environment guide RF conducted EN 61000 4 6 Recommended separation distances RF Radiated 3 Vims from 3 Vims from d 1 2 from 150 KHz to 80 MHz 4 4 90MHzto 80 MHz to d 1 2 NP from 80 MHz to 800 MHz EN 61000 4 3 2 5 GHz 2 5 GHz 1 2 3 from 800 MHz to 2 5 GHz where P is the maximum rated output power of the transmitter in watts W according to the transmitter manufacturer and d is the separation distance in meters m The field strengths from fixed RF transmitters as determined by an electromagnetic site survey may be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with this symbol Ko Recommended separation distance between portable and mobile radio communication equipment and the ECG device The ECG product is intended for use in an electromagnetic environment in which the radiated RF interference is under control The customer or the operator of the device can help prevent electromagnetic interference by maintaining a minimum distance between RF mobile and portable communication devices transmitters and the ECG device as recommended below based on the maximum output power of the radio equipmen
42. omatic time from D1 to V6 Warning pressing this button will delete the previous ECG recording hold in memory if it has not been saved on disk allows recording the selected lead until the operator presses the Stop button The selected lead is highlighted in green in the Lead Selector Panel To record a specific derivation press the button corresponding to the lead or click the button with the left mouse gt Manual button and then press the Manual button Warning pressing the Manual button will delete the current lead recording that will not be recovered unless previously saved on disk The Manual button selection does not delete the data and reports for the specific patient and do not delete any other derivations stored in memory Stop interrupts the ECG recording either in automatic mode either in manual mode In manual recording mode the Lead Selector panel shown below is used to choose the lead derivation In Automatic mode the Lead Selector panel shows the derivation under recording If the system is not recording ECG indicated with the Stop button pressed you can display a specific lead by pressing the corresponding button on the Lead Selector Panel Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 15 Gamma Cardio CG User Manual Lead Selector av aY o 2 r Figure 4 Lead Selector Panel The symbol to the right of each single lead button
43. ording Hopp ppp p Hp E REESE SESS CELIO EHI EHE HHH Xm FEE LEER EE ER HE I pup ARA ie TEE Ee a Compute Distances Noise Filters Lead Selector Muscle Noise Filter Speed mm sec Sensitivity mm my 5 LN Off o gt is rn Medium 35 25 v1 v2 9 Net Filter Tes V4 V5 igh 25 Figure 13 Main application window 4 connect the Gamma Cardio CG Acquisition Unit to your PC using the supplied USB cable see paragraph 3 2 N Warning After connecting the PC to the acquisition unit verify that the message Eta disappears from the screen If this message is still displayed on the screen the ECG device is not connected In this case check carefully the PC device connection 3 Connect the patient cable to the acquisition unit Figure 14 Connection between patient cable and acquisition unit The connection of the electrodes to the patient cable and the electrodes placement on the patient are the most critical steps for an effective ECG recording These steps require greater attention by non expert users In the following paragraphs this operation is then Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 24 Gamma Cardio CG User Manual described in details An experienced user can directly refer to Figure 14 and Figure 15 for the c
44. orrect placement of the electrodes 5 2 Connecting the electrodes to the patient cable The Gamma Cardio CG device includes four high quality reusable silver silver chloride clamp electrodes for connection with the limbs and 6 high quality reusable silver silver chloride suction chest electrodes It is also possible to use disposable electrodes using various adapters as for example the pin clips that can be introduced into patient cable plugs AQ To record a standard resting ECG 12 leads 10 electrodes must be positioned on the patient four at the ends of the limbs and six precordial electrodes on the chest The first step consists of connecting the electrodes on the patient cable plugs The clamp electrodes are connected to the plugs according to the following combination of colors must be e connected to the plug bend is the electrode should be connected to standard colour marked by the color band electrode letter the black black i me 1 ES x wrist Table 3 Connection between electrodes and the patient cable Insert the correct plug of the patient cable into the hole of the electrode by tightening the Screw so as to ensure an effective contact The suction electrodes must be connected to the six remaining pins marked by the initials C2 85 0 7 Make sure that the screw is properly tightened on each suction electrode so as to ensure an effective contact Note that American AHA
45. other computer or on a network or loan rent lease or transfer them to another user except as permitted by this agreement Gamma Cardio Soft Srl DOES NOT warrants that the functions of the Software will meet your requirements or that operation of the Software will be uninterrupted or error free The user assumes all the responsibility for selecting the Software to achieve your intended results and for the use and results obtained from the Software This license is effective until terminated Terminate upon the conditions set out or if the user does not comply with any of its terms Upon termination you agree that the Software and accompanying materials and all copies thereof will be destroyed This contract is governed by Italian law Each provision of this agreement can be separated If a provision is found to be unenforceable this finding affects the enforceability of the remaining provisions terms or conditions of this contract This agreement is binding on successors and assignees The user acknowledges that he has read this agreement that he understands and agrees to be bound by its terms The unauthorized reproduction or distribution of the Gamma Cardio CG Application Program or part of it will be prosecuted under civil and criminal law All trademarks referenced herein belong to their respective owners Gamma CARDIO Sort The heart in the innovation Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 40
46. proved by Gamma Cardio Soft 1 3 Before use 4 Warning do not connect the ECG acquisition unit to the computer until required by the application program refer to Chapter 3 for installation of the ECG Application Program A Do not connect the metal parts of electrodes to the grounding system A Do not use reusable electrodes other than those supplied or equivalent types Poor quality electrodes may degrade recording significantly A Do not use a cable different from the supplied type The system is protected against defibrillator discharge only using the supplied patient cable The patient cable has also been designed to minimize electrical interference that may introduce artefacts in the ECG recording Make sure that the patient cable is properly connected to the acquisition unit The patient cable must be in good conditions in all its parts and properly connected to the electrodes refer to section 5 2 In particular periodically inspect the patient cabls for signs of wear or damage Damaged cables reduce the ECG quality significantly 2 Intended Use Gamma Cardio CG is a professional ECG certified for use in hospitals home care and outpatient The device shall not be used for continuous monitoring of the ECG signal as for example during intensive care or emergency interventions The device can be used in ambulances Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 9 Gamma Cardio CG User Manual Regarding physical safety
47. standard has different color codes 5 3 Electrodes placement An inadequate placement of the electrodes is a main reason for poor quality ECG recording with eventual artifacts as described in section 4 2 interference from power line instability of the isoelectric line muscle tremors It is the highly recommended to perform the following steps with care Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 25 Gamma Cardio CG User Manual Before placing the electrodes 1 place patient on a wide and comfortable bed to prevent muscle contraction that may occur to retain arms and legs on the bed In case of muscles contraction artifacts may be superimposed on ECG recording 2 uncover patient chest eliminating bracelets and watches from patient wrists 3 verify that the patient is not in contact with metal structures of the table or other metallic objects 4 ensure that the ankles are free from garments in order to allow the application of the electrodes Before placing electrodes wipe the contact skin area with a cotton wool soaked in disinfectant or water in order to moisten it In a resting electrocardiogram four clamp electrodes have to be placed on the ankles and wrists For the electrodes placed on the wrists moisten the external face about 10 cm above the wrist For the electrodes placed on the ankles moisten the external face about 10 cm above the malleolus Place each electrode so that the conductive plate is in
48. t Separation distance to the transmitter frequency m Maximum rated power P quency m output of the transmitter 150 kHz to 80 MHz E 800 MHz to 2 GHz For transmitters rated at a maximum output power not included above the recommended separation distance d in meters m can be calculated using the equation applicable to the frequency of the transmitter where P 1s the maximum rated output of the transmitter in watts W according to the transmitter manufacturer Notes 1 At 80 MHz and 800 MHz the applicable frequency range is the highest 2 These guidelines may not be applicable in all situations Electromagnetic propagation 15 affected by absorption and reflection from structures objects and people Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 38 Gamma Cardio CG User Manual 9 Copyright Notice This document is property of the Gamma Cardio Soft Srl via Felice Cascione 10 00128 Rome Italy www GammaCardioSoft it No part of this document may be reproduced transmitted in any form or by any electronic means mechanical photocopying recording transferred to other documents disclosed to third parties or used for any purpose other than that for which the document was conceived without the express written consent of the Gamma Cardio Soft Srl The system specifications are subject to change for updates in the technology in software or requirements The Gamma Cardio Soft Srl reserves the right to modi
49. t is connected to a personal computer through the USB port and a software ECG application for Windows systems The system is easily managed also by users without a specific computer skill Experienced users will quickly use this medical instrument thanks to graphic interface that resembles most commonly used Ecgs Non experienced users will easily record ECGs through the wizard that shows the recording procedure step by step Physicians have specific tools to simplify reporting An interpretation assistant is also included to produce interpretation reports easily In addition the telemedicine functions and the electronic health record system embedded in the product allow for a remote patient monitoring and management Our goal is to make ECG diagnostic exam as simple as possible to allow the widest usage Gamma Cardio Soft Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 5 Gamma Cardio CG User Manual How to use this manual The Gamma Cardio CG system includes the following components ECG Acquisition Unit CD with the ECG Application Program to be installed on the PC The patient cable connecting patient to the acquisition unit Model 6726 E Fiab R or cable approved by Gamma Cardio Soft A set of electrodes to be connected to the patient including 4 peripheral clamp electrodes Model F9024 PLUS or equivalent 6 suction chest electrodes Model F9009 PLUS or equivalent A USB cable between the PC and the acqu
50. x or e mail directly from the ECG Application Program Alternatively the report with the interpretation and the EGG records can be printed or saved on the computer Gamma Cardio CG User Manual v7 17 Mar 2014 EN docx 11 Gamma Cardio CG User Manual 3 Installation 3 1 Minimum Computer Requirements The Gamma Cardio Soft ECG Application Program requires a PC with the following minimum requirements 1 Windows XP Windows Vista Windows 7 Window 8 or later 2 256 MB RAM minimum 3 video card with minimum resolution of 1024 x 600 4 a free USB port The e mail capability of the ECG Application Program may also rely on an e mail system installed on PC compliant with MAPI Microsoft Windows Outlook Express Lotus Notes and the availability of an Internet connection A fax modem card is required to use the fax function In this case the fax printer application has also to be installed on the PC Follow the instructions for the operating system to install Fax On the XP operating system for example you must 1 Open Add or Remove Programs in the Control Panel 2 Click Add or Remove Windows Components 3 In Windows Components Wizard select the Fax Services check box and then follow the on screen instructions 3 2 Installation procedure N Do not connect Acquisition unit before installing the software Before connecting the acquisition unit insert the installation CD into the computer If you accidentally connect t
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