the User Manual Cardialys
Contents
1. 13050077 17 40 04 BlueTooth neighbourhood Inquiry magkita aika 40 00 17 40 10 8 BlueTooth device s seen Remote Device Ctrl D 17 43 16 Discovery of device s profile s 17 43 18 D13050077 1 profile s found 17 43 18 MS SPP dient 00 19 86 00 03 9C is now connect 17 43 19 1 Adding Device Cardialys a 17 43 19 1 Current time is 02 11 2015 at 17 43 19 Nr samples uncompressed 17 43 19 1 Read request of configuration v 2 Nr bytes compressed 17 43 19 1 Serial Number D13050077 F 17 43 19 1 Mac Address 00 71 CC 4E FF 1E Recording length 17 43 19 1 Read request of configuration v 2 17 43 19 1 Read of configuration completed Modem Initialisation GPRS UDP Click on Remote Mac Address Then click on Write to save the new MAC address 10 15 2015 Version Page 44 of 68 User Manual Cardialys _ D13050077 Remote Mac Address 00 71 CC 4E FF 1E 17 40 04 BlueTooth 17 40 10 8 BlueTooth es seen 17 43 16 Discovery of device s profile s 17 43 18 D13050077 1 profile s found 17 43 18 MS SPP client 00 19 86 00 03 9C is now conneci 17 43 19 1 Adding Device Cardialys 17 43 19 1 Current time is 02 11 2015 at 17 43 19 17 43 19 1 Read request of configuration v 2 17 43 19 1 Serial Number D13050077 17 43 19 1 Mac Address 00 71 CC 4 FF 1E 17 43 19 1 Read request of configuration v 2 17 43 19 1 Read of configuration comple2. We recommend you to communicate the name of the stack provider to the PARSYS Telemedicine After Sales Service before any installation N In the latter case we recommend not to try the installation before obtaining confirmation procedure by the PARSYS Telemedicine After Sales Service 10 15 2015 Version Page 37 of 68 4 3 2 Pairing of Cardialys with a Windows 8 8 1 PC Insert the USB Bluetooth adapter into an USB port on the PC then run the installation CD If the CD does not run automatically please run it manually in Windows Explorer 10 15 2015 Version BlueTooth O Device Install Parsys Software Install PDFCreator Software Quit installation PARSYS Agree and Install Bluetooth Software You have read and agreed to the terms of the license agreement Click to start the installation process Do not install You do not want to install this software and would like to eat this program By installing this software application you agree you have read and accepted the Bluetooth End User License Agreement Click on Agree and Install Bluetooth Software Page 38 of 68 User Manual Cardialys Use Bluetooth hands free devices to do calls over Skype or other VoIP applications Wait until the installation completes Installation Complete Thank you Some of the Bluetooth functionality might not be available until the next time y
3. ECG Preview ee Place the precordial YA electrodes from V1 Fa C a N to V6 according to DEREI the recommendations No NA of use 1 A 5 ECG Preview With a 18 Lead cable Position the V3R V4R and V5R electrodes symmetrically from V3 V4 and V5 V5R can also be A positioned in VE according to practice 10 15 2015 Version Page 54 of 68 ECG Preview With a 18 Lead cable Position the V7 V8 and V9 electrodes on the subject s back ECG Preview Position the peripheral electrodes aVR aVL and the Neutral 10 15 2015 Version Page 55 of 68 ECG Preview Connect the differentiator and the wired electrodes ECG Preview Press the ON button on the differentiator until the eip comes on 10 15 2015 Version Page 56 of 68 ECG Preview The light is displayed on the differentiator unit to indicate that the RADIO LINK is ESTABLISHED ECG Preview The patient should remain CALM and RELAXED during capture 10 15 2015 Version Page 57 of 68 ECG Preview The ECG trace is continuously and automatically transmitted to the terminal Personal Computer or Touchscreen Tablet ECG Preview J Press the Capture button to make an ECG capture 10 15 2015 Version Page 58 of 68 ECG Preview The ECG capture is automatically displayed on the screen ECG Preview L Press again the ON button on the differentiator unit until the light off
4. a a M AA DSR InstallShield Wizard Completed The InstallShield Wizard has successfully installed WIDCOMM Bluetooth Software Click Finish to exit the wizard Some of the Bluetooth Functionality might not be available until the next time you log on Click on Finish Open the Program Files folder 32 bit processors or Program Files x86 64 bit processors Accueil Partage Affichage Gestion A X Couper kh XxX p 4 Nouvel l ment m Ouvrir EH S lectionner tout E Copier le chemin d acc s i Acc s rapide a Modifier 55 Aucun Copier Coller D placer Copier Supprimer Renommer Nouveau Propri t s a Coller le raccourci vers vers x dossier x Historique oo Inverser la s lection Presse papiers Organiser Nouveau Ouvrir S lectionner v T gt CePC Disquelocal C Program Files x86 Parsys NG Rechercher d LL O Nom Modifi le Type Taille E Bureau socket dll 11 06 2015 14 33 Extension de l app 552 Ko E Emplacements r cer sqimdb dil 11 06 2015 14 32 Extension de l app 78 Ko B T l chargements a tcf exe 11 06 2015 14 34 Application 100 Ko ai tcgprint exe 11 06 2015 14 35 Application 117 Ko Groupe r sidentiel a tcgtocsv exe 11 06 2015 14 37 Application 25 Ko A seb Walicki a tcgtojpg exe 11 06 2015 14 35 Application 159 Ko E tcgtoxml exe 11 06 2015 14 35 Application 158 Ko Bi cepc me nn EY ae ee oZ u R seau men B telecardialys
5. interference Check that the capture protocol has been followed in particular the correct position of the electrodes absence of contact between the electrodes and any objects likely to cause electrical interference absence of mobile phones nearby The patient and operator must be as relaxed as possible in order to avoid any tense movements when capturing the ECG 12 3 The Cardialys ECG remains frozen when in operation If the machine blocks when in operation for more than 1 minute use the reset cable or a metallic object paper clip pair of scissors or wire to connect the charging contacts under Cardialys and hold in contact for 1 second place the equipment back on the charger and wait for the Charger indicator to come on connect in settings mode to update the internal real time clock stop then restart the instrument 12 4 The Cardialys ECG is not charging Check that the charging protocol has been followed in particular that the Cardialys is in the correct position on the charger that the wired cable has been disconnected during charging to unburden Cardialys and to ensure proper contact with the metal contacts on the base that the red LED on the base is on during charging that the base is correctly plugged into the mains Should you note a low battery level after 1 hour s charging please contact the PARSYS Telemedicine After sales Service 10 15 2015 Version Page 67 of 68 13 PARSYS Telemedici
6. to encrypt the data thatthe Qos devices exchange To complete the pairing process type the required passkey and then click Next If you donot know the passkey see the instructions that came with T07 J Le Ga Enter the pairing passkey The installer asks for a passkey Type the code 02101124 and click on Next gt 10 15 2015 Version Page 22 of 68 User Manual Cardialys Bluetooth Service Selection Select the services you are interested in The following services are available through the selected Bluetooth Device Select the service that you want to access on the selected device Bluetooth Serial Port Establish a virtual serial port connection with a remote application that supports the COM port number assigned Te Click on Finish My Bluetooth Places Shortcuts for the selected services have been created on the My Bluetooth Places screen of Windows Explorer Create shortcuts Click on Do not display this message again then on OK Explore My Bluetooth Places Add a Bluetooth Device Bluetooth Configuration Quick Connect b Stop the Bluetooth Device To finalize the installation of the Bluetooth device make a right click on the Bluetooth icon in the bottom right of the screen Then click on Bluetooth Configuration 10 15 2015 Version Page 23 of 68 User Manual Cardialys Bluetooth Configuration General Accessibility Loca
7. to turn it off 10 15 2015 Version Page 59 of 68 7 Updating the PC software device firmware We shall contact you periodically by e mail concerning download of updated software firmware versions The updates are performed during maintenance 10 15 2015 Version Page 60 of 68 PARSYS User Manual Cardialys 8 Electromagnetic emissions Table 1 Directives and MANUFACTURER S statement ELECTROMAGNETIC EMISSIONS For all DEVICES and EM SYSTEMS Directives and manufacturer s statement electromagnetic emissions The device is made to be used in the electromagnetic environment specified below The client or user of the device must ensure that the device is used in such environment Eman Conformity Electromagnetic environment directives The device uses RF energy only through his internal RF Emissions Group 1 functions As a consequence its RF emissions are very CISPR 11 weak and are not likely to cause interferences in a nearby electronic device RF Emissions Class B CISPR 11 T TEE The charging power box catalogue product must armonic Emissions Non applicable solely be used with the device in sleep mode CEI 61000 3 2 disconnected from the patient Pulse fluctuations Ne Flicker CEI 61000 3 3 A Table 2 Directives and MANUFACTURER S statement electromagnetic IMMUNITY For all DEVICES and EM SYSTEMS Directives and manufacturer s statement electromagnetic immunity The device is made to be u
8. with the ground or other exposed metal parts When the ECG is capturing the device s differentiator box must be in contact with the patient In case of a simultaneous use of the device and another it should take care that the sum of the patient leakage currents to the ground doesn t exceed safety limits In case of a simultaneous use of the device with a defibrillator do not place the defibrillator s electrodes into contact with the device s electrodes 10 15 2015 Version Page 6 of 68 PARSYS User Manual Cardialys 2 Equipment description 2 1 Overview ON OFF button starts stops the device 6 KO 2 ON OFF LED o y N N Charging contacts Cardialys is a portable electrocardiograph with the following characteristics capture by wired electrodes possibility of acquiring a 12 or 18 lead ECG on the same number of tracings each lead is recorded simultaneously over a 12 second period or an adjustable period on request during use in autonomous mode transmission of the signal to a PC via Bluetooth lla class ECG device for temporary use 10 15 2015 Version Page 7 of 68 2 2 Functional description 2 2 1 Use in Direct mode Cardialys can be set to automatically capture and transmit an ECG trace to a PC with the supplied software Telecardialys configured in Direct mode direct capture of an ECG trace without preview 2 2 2 Use in Preview mode Cardialys can be set to automatically capt
9. 0 03 9C is now connect Amplitude sensibility ONEMV 34 17 43 19 1 Adding Device Cardialys 17 43 19 1 Current time is 02 11 2015 at 17 43 19 a 17 43 19 1 Read request of configuration v 2 Nr bytes compressed 17 43 19 1 Serial Number D13050077 BE 17 43 19 1 Mac Address 00 71 CC 4E FF 1E Pera ania 17 43 19 1 Read request of configuration v 2 17 43 19 1 Read of configuration completed Modem Initialisation GPRS UDP The interface window with the medical device is then visible Action Edit BlueTooth Languages Soft Version 21 18 Hard Version 00 10 Message Version NM SerialNr v D13050077 17 40 04 BlueTooth neighbourhood In 17 40 10 8 BlueTooth device s seen 17 43 16 Discovery of device s profile s 17 43 18 D13050077 1profile s found 17 43 18 MS SPP dient 00 19 86 00 03 9C is now conneci 17 43 19 1 Adding Device Cardialys N 17 43 19 1 Current time is 02 11 2015 at 17 43 19 ee 17 43 19 1 Read request of configuration v 2 Nr bytes compressed 17 43 19 1 Serial Number D13050077 a 17 43 19 1 Mac Address 00 71 CC 4E FF 1E an 17 43 19 1 Read request of configuration v 2 17 43 19 1 Read of configuration completed Modem Initialisation GPRS UDP Click on Remote Mac Address Then click on Local Device The PC MAC address will be registered 10 15 2015 Version Page 34 of 68 User Manual Cardialys Soft Version 21 18 Batte
10. 11 5 ECO NG aa ANA AA AA AA 12 INSTALLATION OF TELECARDIALYS PC SOFTWARE cccesseceseeceseensseeseeeenseenseeeeseenneesasennass 13 BLUETOOTH PAIRING PROCEDURE OF THE CARDIALYS TO A PC nnnrnnnnnne 14 4 1 WINDOWS XP OPERATING SYSTEM 2020000007710 a 15 4 2 WINDOWS 7 OPERATING SYSTEM 2magnuoa saba ONG daa ANAKAN 0 IA 26 A1 SATII OU NES srei nee nn dd ne be le a ae ot 26 4 2 1 1 Check if the PC fixed portable PC ultraportable Tablet PC to pair with the ECG includes a preinstalled Bluetooth internal module 26 4 2 1 2 If no internal module is preinstalled use the Bluetooth USB adapter supplied with your kit 26 4 2 1 3 If your computer is equipped with a preinstalled Bluetooth internal module check the origin of its stack 26 4 2 2 Pairing of Cardialys with a Windows 7 PC rires 27 4 3 WINDOWS 8 8 1 OPERATING SYSTEM 0000000070000 37 AST BG O LG AA ta cie it ie 37 4 3 1 1 Check if the PC fixed portable PC ultraportable Tablet PC to pair with the ECG includes a preinstalled Bluetooth internal module sise 37 4 3 1 2 If no internal module is preinstalled use the Bluetooth USB adapter supplied with your kit 37 4 3 1 3 If your computer is equipped with a preinstalled Bluetooth internal module check the origin of its stack 37 4 3 2 Pairing of Cardialys with a Windows 8 8 1 PC 38 USING TELECARDIALYS PC SOFTWARE cccccceseceseceeeceeeceneeeseeessensee
11. 200 to C Program Files WIDCOMM Bluetooth Software InstallShield j Cancel Click on Next gt i WIDCOMM Bluetooth Software 5 5 0 9200 Ready to Install the Program The wizard is ready to begin installation Click Install to begin the installation IF you want to review or change any of your installation settings click Back Click Cancel to exit the wizard InstallShield ma Click on Install 10 15 2015 Version Page 17 of 68 User Manual Cardialys i WIDCOMM Bluetooth Software 5 5 0 9200 Installing WIDCOMM Bluetooth Software The Bluetooth software is being installed Please wait while the InstallShield Wizard installs WIDCOMM Bluetooth Software This may take several minutes Status Copying new files COO a InstallShield Wait until the installation completes i WIDCOMM Bluetooth Software InstallShield Wizard Completed The InstallShield Wizard has successfully installed WIDCOMM Bluetooth Software Click Finish to exit the wizard Some of the Bluetooth Functionality might not be available until the next time you log on Click on Finish 10 15 2015 Version Page 18 of 68 User Manual Cardialys Explore My Bluetooth Places Add a Bluetooth Device Bluetooth Configuration Quick Connect b Stop the Bluetooth Device Make a right click on the Bluetooth icon at the bottom right of the screen Send Business Card Blue
12. 8 Ko Ss tkOb dll 11 06 2015 14 32 Extension de l app 1194 Ko Ss tkOc dll 11 06 2015 14 32 Extension de l app 160 Ko 3 tkOd dil 11 06 2015 14 32 Extension de l app 308 Ko Sy tk01 dil 11 06 2015 14 32 Extension de l app 290 Ko Ss tk03 dil 11 06 2015 14 32 Extension de l app 67 Ko Ss tk04 dil 11 06 2015 14 32 Extension de l app 94 Ko S tki dil 11 06 2015 14 38 Extension de l app 3 709 Ko S twainmgr dil 11 06 2015 14 35 Extension de l app 33 Ko L unins000 dat 25 06 2015 19 38 Fichier DAT 117 Ko B unins000 exe 25 06 2015 19 37 Application 1 446 Ko wavecom dil 11 06 2015 14 32 Extension de l app 74 Ko wbtsowl dil 11 06 2015 14 33 Extension de l app 456 Ko S wbtsvc dil 11 06 2015 14 31 Extension de l app 227 Ko 50 l ment s 1 l ment s lectionn 267 Ko Then open the Parsys folder and start the TCP EXE software Remote Device Start HANDSHAKE FH S lectionner tout Sa Aucun oo Inverser la s lection S lectionner Crtl B v When the software is opened set the device Call Client mode 10 15 2015 Version Rechercher d Page 40 of 68 p PARSYS User Manual Cardialys Ver 3 0 PARSYS TELEMEDECINE KN ual i KE 118 avenue de France F 75013 PARIS support parsys com NE Qi ULE 0459 LULU Cardialys 25 005 V1 1 35 C Turn back the Cardialys box Note the device ID S N on its labe
13. 9C is now conneci 17 43 19 1 Adding Device Cardialys 17 43 19 1 Current time is 02 11 2015 at 17 43 19 L 17 43 19 1 Read request of configuration v 2 Nr bytes compressed 17 43 19 1 Serial Number D13050077 17 43 19 1 Mac Address 00 71 CC 4E FF 1E ee 6 Gai 17 43 19 1 Read request of configuration v 2 Battery Measure Se aa bina maa aag Modem Initialisation GPRS UDP Low High The interface window with the medical device is then visible 10 15 2015 Version Page 43 of 68 User Manual Cardialys Soft Version 21 18 Hard Version 00 10 Message Version NM sa m7 17 40 04 BlueTooth neighbourhood In 17 40 10 8 BlueTooth device s seen 17 43 16 Discovery of device s profile s 17 43 18 D13050077 1 profile s found 17 43 18 MS SPP dient 00 19 86 00 03 9C is now connect 17 43 19 1 Adding Device Cardialys f 17 43 19 1 Current time is 02 11 2015 at 17 43 19 eee 17 43 19 1 Read request of configuration v 2 Nr bytes compressed 17 43 19 1 Serial Number D13050077 k 17 43 19 1 Mac Address 00 71 CC 4E FF 1E Pasasaan 17 43 19 1 Read request of configuration v 2 17 43 19 1 Read of configuration completed Modem Initialisation GPRS UDP Click on Remote Mac Address Then click on Local Device The PC MAC address will be registered Action Edit BlueTooth Languages Soft Version 21 18 Hard Version 00 10 Message Version VM SerialNr
14. PARSYS Telemedecine Head office 118 avenue de France 75013 Paris France Technical center 5 7 avenue de Paris 94300 Vincennes France Tel 33 0 1 60 31 70 40 Fax 33 0 1 64 02 31 93 info parsys com User Manual CARDIALYS 37 055 V3 0 Date of the first placing on the market of the product 04 05 2010 C o459 TELEMEDECINE 10 15 2015 Version SUMMARY 1 R CONTENT ws cerca ca cm cia eae na sc ecw ct ceteea rewe e ee etm eee cece eee see neeeans 4 1 1 COMPONENTS AND ACCESSORIES OF THE KIT ccceceececcecceceececceeeeceeeeeseeeeceeceuneeaeeeesenaeseeeeseeaeseenenneeeesenness 4 1 2 LIST AND EXPLANATION OF THE MEANING OF THE SYMBOLS USED 2 200007 nnn 5 1o WARNINGS AA 6 2 EQUIPMENT DESGRIPTION 722 AASA AA 7 al NERVE seen nee nee seed ee ANA PA AA AA pA 7 22 FUNCTIONALPESCRIPTION TAN eo GRAE NG GANA en ne dde Ce de 8 CE SCI DOC MOOO a AA 8 CE WSC TA OI EN Oe a De nn on ee ee 8 2 2 3 Starling Stopping the devi E siccsiszinicesccczrestsesguassctetscadsnendensorsz e EE EER 8 ETE ND CDC ae ea eee ee a ae anne et ee ou 9 2 4 GHARGING SYSTEME msama AG a dose nee aaa 10 CO SO 10 2 4 2 Starting the charger scccccccseececcccnseeseeecsnaeueeecssnaucseecesaauuneeessaaeeueeessaaauseeesssaaaaeeesssaaaeeesssaaaaseess 10 2 4 3 Description of indicators sise 10 2 4 4 Cardialys charging procedure seen 10 2 4 5 When should charge Cardialys 7
15. RMS IN THIS END USER LICENSE AGREEMENT PLEASE READ THE TERMS CAREFULLY BY CLICKING ON THE YES BUTTON YOU ACKNOWLEDGE THAT YOU HAVE READ THIS AGREEMENT UNDERSTAND IT AND AGREE v OT do not accept the terms in the license agreement InstallShield Ca fus Accept the agreement then click on Next gt i WIDCOMM Bluetooth Software 5 5 0 9200 Destination Folder Click Next to install to this Folder or click Change to install to a different folder CI Install WIDCOMM Bluetooth Software 5 5 0 9200 to C Program Files WIDCOMMiBluetooth Software InstallShield Cancel Click on Next gt 10 15 2015 Version Page 28 of 68 User Manual Cardialys i WIDCOMM Bluetooth Software 5 5 0 9200 Ready to Install the Program The wizard is ready to begin installation Click Install to begin the installation If you want to review or change any of your installation settings click Back Click Cancel to exit the wizard InstallShield Install Cancel Click on Install i WIDCOMM Bluetooth Software 5 5 0 9200 Installing WIDCOMM Bluetooth Software The Bluetooth software is being installed Please wait while the InstallShield Wizard installs WIDCOMM Bluetooth Software This may take several minutes Status Copying new files InstallShield Wait until the installation completes 10 15 2015 Version Page 29 of 68 User Manual Cardialys i WIDCOMM Bluetooth Software IE
16. aessuaeseuaeeas 65 11 USERS TRAINING a ANNA TA AA ee eee ee eee 66 12 FAULT OR AA ARA 67 12 1 THE CARDIALYS ECG DOES NOT SEND ANY TRACE cscececccecececccccececuccccececcceaececscueauaesecstauaeneneretass 67 12 2 THE ECG IS SUBJECT TO INTERFERENCE wc cetceadecacicoutcvereasnevine acsauavesccandnndvasesmtecaswdeneve AA ANA NAAN 67 12 3 THE CARDIALYS ECG REMAINS FROZEN WHEN IN OPERATION ssccecececcecccececcecaccececcececaccucecceceuaecass 67 12 4 THE CARDIALYS ECG IS NOT CHARGING u s 67 13 PARSYS TELEMEDICINE WARRANTY AND AFTER SALES SERVICE cccescecescecescecesecesceenss 68 10 15 2015 Version Page 3 of 68 We thank you for having chosen PARSYS Telemedicine equipment We hope that it will bring you full satisfaction in your daily electrocardiography practice 1 Kit contents 1 1 Components and accessories of the kit ON OFF button aS Ui Starts Stops the device M ka Lz N ja EA Bluetooth LED Radio link status Charging contacts Firstly please check the components and accessories of your Cardialys Kit Ref 200 001 2 3 4 12 derivations with clips Ref 200 003 2 derivations with bananas Ref 200 001 18 derivations with clips Ref 200 004 18 derivations with bananas Ref 200 002 It must contain the following items 1 Differentiator box Cardialys Ref 25 005 1 Bluetooth USB adapter Ref 36 002 1 Patient cable according to option v 12 lead with clips 4mm Re
17. ally in Windows Explorer Parsys Software Install PDFCreator Software Quit installation PARSYS Do nothing until this window appears Click on Install Bluetooth Device 10 15 2015 Version Page 15 of 68 User Manual Cardialys Welcome to the InstallShield Wizard for WIDCOMM Bluetooth Software 5 5 0 9200 The Install5hield R Wizard will install WIDCOMM Bluetooth Software 5 5 0 9200 on your computer To continue click Next WARNING This program is protected by copyright law and international treaties j Cancel Click on Next gt i WIDCOMM Bluetooth Software 5 5 0 9200 License Agreement Please read the Following license agreement carefully END USER LICENSE AGREEMENT THE SOFTWARE ACCOMPANYING THIS END USER LICENSE AGREEMENT THE SOFTWARE IS LICENSED TO YOU ONLY ON THE CONDITION THAT YOU ACCEPT ALL OF THE TERMS IN THIS END USER LICENSE AGREEMENT PLEASE READ THE TERMS CAREFULLY BY CLICKING ON THE YES BUTTON YOU ACKNOWLEDGE THAT YOU HAVE READ THIS AGREEMENT UNDERSTAND IT AND AGREE v O1 do not accept the terms in the license agreement InstallShield ex No Accept the agreement then click on Next gt 10 15 2015 Version Page 16 of 68 User Manual Cardialys i WIDCOMM Bluetooth Software 5 5 0 9200 Destination Folder Click Next to install to this Folder or click Change to install to a different folder ey Install WIDCOMM Bluetooth Software 5 5 0 9
18. aseeaseonseoasecasennseoasenasenaes 46 COCAPTORES DAANAN NLA AA NA AA 47 6 1 CARDIALYS IN DIRECT MODE 2200000 000 47 6 2 GARDIALYS IN PREVIEW MODE 0202200000110 AA 53 UPDATING THE PC SOFTWARE DEVICE FIRMWARE cccccssscsssccssecssecseecseeneeneeeneeseseaesenes 60 ELECTROMAGNETIC EMISSIONS 00200020000200 aman aman aasa nG ANGKAN NAA NN KANA A NAAN NAAN KA ANAN ANAN ANNA ANNA ANNA ANNA ANNA ANNA 61 TECHNICAL PEATURES ANA een ended weekends nt ee ncn 64 9 1 INDIVIDUAL RECORDING CHARACTERISTICS cecceceececcecceceeceeeeeeeceeeeeeeeeeceeseeseeueeeeseeneseeeeeneeaeeeenenaeeeesenness 64 92 QGENERALFEATUR G aNG ri ernn enaena Aa n 64 9 3 ELECTRICAL SPECIFICATIONS ccccceceececcecceceeceececeeceeceececeeceeseeeeceseuseeeeceeseeeeeaeceeneeeecseseuseraeseeneeneenesenness 64 10 MAINTENANCE 2 de a do 65 10 15 2015 Version Page 2 of 68 10 1 CLEANING DISINFECTION c ceccececcececcececcecuccececececuececuucecueaucueuececausecuenecuunecsuaecsuaecsueseccesecscaeceuaesass 65 10 2 PROCEDURE IN THE EVENT THAT THE INSTRUMENT IS DROPPED OR FALLG ccceccececcecceccececceceeceececeeeee 65 10 3 RESET PROCEDURE ccccceccececcececcccecccececcecuucecuecucseuucecuucecsececuenucueuunueuucecsucecsuaecsueueeauaucausecsuaesseaeeas 65 10 4 METROLOGICAL CHECKS 211 senc eemeecemecemeneemen een eee anaana 65 10 5 PROCESSING OF OUT OF USE EQUIPMENT cccccececcececcececcecccececcecuccececuceucuececueaecueaeeueuececat
19. compliance level above it is necessary to observe the behavior of the medical device to check that the operation is normal If abnormal performances are observed additional measures may be necessary such as reorienting or repositioning of the medical device on its operation site b In the frequency range of 150kHz to 80MHz it is appropriate that the field strengths are smaller than 3 V m 10 15 2015 Version Page 62 of 68 PARSYS User Manual Cardialys Recommended separation distances between portable and mobile RF communicating devices and the medical device The medical device is intended for use in an electromagnetic environment where radiated RF disturbances are controlled The customer or the user of the device can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communicating device transmitter and the medical device as recommended below according to the maximum power emission of the communication device Fane miter maxon Separation distance according to the transmitter frequency m Asolgnpa a output from 150kHz to 80MHz from 150kHzto 80MHz from 150kHz to 80MHz d 1 2VP d 1 2VP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters whose maximum assigned transmission power is not given above the recommended separation distance d in meters m can be estimated b
20. d Dial up Networking Required Network Access Required Bluetooth Serial Port Required COM4 Add COM port Delete COM port Ae Go to the Client Applications tab Click on Bluetooth Serial Port Then click on Properties Bluetooth Properties COM Pott Uncheck Secure connection Click on Apply then on OK 10 15 2015 Version Page 25 of 68 4 2 Windows 7 Operating System 4 2 1 Requirements 4 2 1 1 Check if the PC fixed portable PC ultraportable Tablet PC to pair with the ECG includes a preinstalled Bluetooth internal module Note In the case of a fixed PC there is a good chance that there is no internal module but mobile computers often have a preinstalled Bluetooth internal module 4 2 1 2 If no internal module is preinstalled use the Bluetooth USB adapter supplied with your kit tis fundamental that your computer has an active Internet connection Just plug your Bluetooth USB adapter on a USB port driver installation is automatic via the Internet N In this case your computer must be connected to the Internet to install the Bluetooth USB adapter driver updating 4 2 1 3 If your computer is equipped with a preinstalled Bluetooth internal module check the origin of its stack Microsoft WidComm stack Pairing is automatic between Cardialys and the computer you have no other manipulation to perform Another provider stack We recommend you
21. ed into the rear of the machine unit The Cardialys charger is a horizontal or vertical mounting model specially designed for use on carts cases or vehicles potentially in confined spaces 2 4 2 Starting the charger The charger charges the machine completely in approximately 2 5 hours using a 220V 50Hz source via the mains adapter supplied The charger requires a 220V 50HZ power source So just plug it into the mains to power it and therefore proceed with charging the Cardialys ECG battery The Cardialys charger does not have a switch Charging the device switches on when the charger receives the necessary power from the power cable connected to the mains We recommend you not to modify the Cardialys charger as permanent damage not covered by the warranty of the device 2 4 3 Description of indicators The charge light indicator is OFF while Cardialys is not correctly inserted or missing from the slot RED as Cardialys is charging GREEN when Cardialys is charged 2 4 4 Cardialys charging procedure The Cardialys ECG must be positioned in the load position screws must be inserted in the charger to ensure good contact with the charging metal contacts i Warning The Cardialys box WITH its Patient cable fixed together by clamping The charger ensures full recharging of Cardialys in about 2 5 hours N WARNING THE DEVICE MUST NOT BE USED WHILE IT IS CHARGING 10 15 2015 Version Page 10 of 68 2 4 5 Whe
22. exe 11 06 2015 14 38 Application 5 519 Ko Ss tk00 dil 11 06 2015 14 31 Extension de l app 239 Ko tk0a dil 11 06 2015 14 32 Extension de l app 708 Ko tkOb dll 11 06 2015 14 32 Extension de l app 1 194 Ko tkOc dll 11 06 2015 14 32 Extension de l app 160 Ko tkOd dll 11 06 2015 14 32 Extension de l app 308 Ko tk01 dil 11 06 2015 14 32 Extension de l app 290 Ko tk03 dil 11 06 2015 14 32 Extension de l app 67 Ko tk04 dil 11 06 2015 14 32 Extension de l app 94 Ko 2 tki dil 11 06 2015 14 38 Extension de l app 3 709 Ko twainmgr dil 11 06 2015 14 35 Extension de l app 33 Ko _ unins000 dat 25 06 2015 19 38 Fichier DAT 117 Ko B unins000 exe 25 06 2015 19 37 Application 1 446 Ko 3 wavecom dil 11 06 2015 14 32 Extension de l app 74Ko wbtsowl dil 11 06 2015 14 33 Extension de l app 456 Ko wbtsvc dil 11 06 2015 14 31 Extension de l app 227 Ko 50 l ment s 10 15 2015 Version 1 l ment s lectionn 267 Ko Then open the Parsys folder and start the TCP EXE software Page 30 of 68 User Manual Cardialys Cas ocal L EVICE Remote Device Start HANDSHAKE Crtl B When the software is opened set the device Call Client mode PARSYS TELEMEDECINE o 4 H 118 avenue de France 35 C F 75013 PARIS support parsys com dk LS S N D07050001 0459 LULU Cardialys 25 005 V1 1 Turn back t
23. f 23 023 A v 12 lead with bananas Ref 23 023 B v 12 to 18 lead clips 4mm Ref 23 024 A v 12 to 18 lead bananas Ref 23 024 B 1 Charging base DC 5V 1 1A Ref 25 019 1 Medical EN 60601 5V power supply and cord Ref 16 001 1 Water spray Ref 36 006 1 Reset black cord for device reset Ref 23 051 1 Carry case Ref 34 003 1 User Manual Cardialys EN Ref 37 055 1 Warranty Card EN Ref 37 003 If any of the items is missing please contact us at the address given in the manual 10 15 2015 Version Page 4 of 68 1 2 List and explanation of the meaning of the symbols used Warning consult attached documents O gt Please read the notice pa BF type applied part Do not dispose of in the bin but through the appropriate recycling channels Non ionizing radiation Product manufactured by PARSYS Telemedecine Ep x Device climatic range of use or storage S N Serial number oN N Medical device European compliance 10 15 2015 Version Page 5 of 68 1 3 Warnings PARSYS Telemedicine draws the attention of the user on the following points regarding AN AN The device must not be used simultaneously with an electric surgery tool The device is not intended for cardiac direct use reserved to CF class devices The ECG capture must not be performed when the device is charging on its charger When the ECG is capturing electrodes unplugged on the patient must not come into contact
24. f configuration v 2 17 43 19 1 Read of configuration completed Modem Initialisation GPRS UDP Click on Disconnect 10 15 2015 Version Page 35 of 68 User Manual Cardialys P D13050077 17 40 04 BlueTooth neighbourhood In 17 40 10 8 BlueTooth device s seen Back to the start window of the TCP software Close the window to exit 10 15 2015 Version Page 36 of 68 4 3 Windows 8 8 1 Operating System 4 3 1 Requirements 4 3 1 1 Check if the PC fixed portable PC ultraportable Tablet PC to pair with the ECG includes a preinstalled Bluetooth internal module Note In the case of a fixed PC there is a good chance that there is no internal module but mobile computers often have a preinstalled Bluetooth internal module 4 3 1 2 If no internal module is preinstalled use the Bluetooth USB adapter supplied with your kit tis fundamental that your computer has an active Internet connection Just plug your Bluetooth USB adapter on a USB port driver installation is automatic via the Internet N In this case your computer must be connected to the Internet to install the Bluetooth USB adapter driver updating 4 3 1 3 If your computer is equipped with a preinstalled Bluetooth internal module check the origin of its stack Microsoft WidComm stack Pairing is automatic between Cardialys and the computer you have no other manipulation to perform Another provider stack
25. he Cardialys box Note the device ID S N on its label Number starting with D 10 15 2015 Version Page 31 of 68 Make the connection Hold down the ON OFF button until the display of its ID on the screen Action Edit BlueTooth Languages D13050077 00 07 80 51 E4 22 17 40 04 BlueTooth nei Inquir 17 40 10 8 BlueTooth device s seen The different connectable Bluetooth devices are recognized by the system You can refine the search by type of equipment Telecardia Cardialys etc 10 15 2015 Version Page 32 of 68 User Manual Cardialys Action Edit BlueTooth Languages P 17 40 04 BlueTooth neighbourhood In 17 40 10 8 BlueTooth device s seen If the search is unsuccessful you can click on Refresh which will start a new search Action Edit BlueTooth Languages P 17 40 04 BlueTooth neighbourhood 17 40 10 8 BlueTooth device s seen Once the desired device is visible click its icon although check the serial number Then click on Choose 10 15 2015 Version Page 33 of 68 User Manual Cardialys Soft Version 21 18 Battery 92 Hard Version 00 10 a Message Version MM SerialNr 13050077 Remote Mac Address 00 71 CC 46 FF 1E 17 40 04 BlueTooth nei In 17 40 10 8 BlueTooth device s seen 17 43 16 Discovery of device s profile s 17 43 18 D13050077 1 profile s found 17 43 18 MS SPP dient 00 19 86 0
26. he ON OFF button until the display of its ID on the screen Bluetooth Device Selection Select a device Remote devices must be in Discoverable mode for this computer to find them For assistance in making a remote device discoverable refer to the remote device s documentation vs 8 E amp B07050132 B07050254 CHARIOT ORDI VALIDA PC SEB a 8 Station test 107050343 Search Again Show all devices If the device you are looking for is not in the list verify that the device has power and is operational On some devices you must press the Connect button to make the device discoverable Select the device In the list select your Cardialys and click on Next gt If necessary click on Search Again 10 15 2015 Version Page 21 of 68 User Manual Cardialys Bluetooth Security Setup Bluetooth Pairing Paired devices exchange a secret key each time they connect This key is unique a s for each pair of devices it is used to verify identity and to encrypt the data thatthe Qos devices exchange To complete the pairing process type the required passkey and then click Next If you do not know the passkey see the instructions that came with T07 J P Pairing Pairing starts with Cardialys Bluetooth Security Setup Bluetooth Pairing Paired devices exchange a secret key each time they connect This key is unique yi for each pair of devices it is used to verify identity and
27. l Number starting with D Make the connection Hold down the ON OFF button until the display of its ID on the screen 10 15 2015 Version Page 41 of 68 User Manual Cardialys Action Edit BlueTooth Languages D13050077 00 07 80 51 E4 22 Services 17 40 04 BlueTooth neighbourhood Inquir 17 40 10 8 BlueTooth device s seen The different connectable Bluetooth devices are recognized by the system You can refine the search by type of equipment Telecardia Cardialys etc Action Edit BlueTooth Languages P D13050077 00 07 80 51 E4 22 17 40 04 BlueTooth neighbourhood Inquir 17 40 10 8 BlueTooth device s seen If the search is unsuccessful you can click on Refresh which will start a new search 10 15 2015 Version Page 42 of 68 User Manual Cardialys Action Edit BlueTooth Languages 17 40 04 BlueTooth neighbourhood Inquir 17 40 10 8 BlueTooth device s seen Once the desired device is visible click its icon although check the serial number Then click on Choose Action Edit BlueTooth Languages K kan Battery 92 D13050077 D0 00 07 50 51 E4 22 Disconnect Serial D13050077 Remote Mac Address 00 71 CC 4E FF IE 17 40 04 BlueTooth neighbourhood Inquiry 17 40 10 8 BlueTooth device s seen 17 43 16 Discovery of device s profile s 17 43 18 D13050077 1profile s found 17 43 18 MS SPP client 00 19 86 00 03
28. l Services Client Applications Diagnostics Select the services that this computer will provide to other Bluetooth devices Double click a service name to set its security start up options and properties Service Name Startup j Secure Connection COM Port Printer Manu Required Bluetooth Imaging Auto Required Audio Gateway Auto Required Headset Auto Required PIM Synchronization Auto Required File Transfer Auto Required PIM Item Transfer Auto Required Dial up Networking Manu Required Network Access Auto Required Bluetooth Serial Port Auto Required Go to the Local Services tab Click on Bluetooth Serial Port Then click on Properties Bluetooth Properties Notifications COM Pott Check Start up automatically and uncheck Secure connection Click on Apply then on OK 10 15 2015 Version Page 24 of 68 User Manual Cardialys Bluetooth Configuration General Accessibility Local Services Client Applications Diagnostics Specify how this computer will access services on other Bluetooth devices Double click an application name to set its security and edit its properties Application Name Secure Connection COM Part Bluetooth Imaging Required Human Interface Device Not Required Printer Required Audio Gateway Required Headset Required PIM Synchronization Required Fax Required File Transfer Required PIM Item Transfer Require
29. lys Reading Printing Sending PARSYS ECG reading centre Cardiologist or dedicated centre ALAN SET ee Bluetooth transmission ae Charging base 10 15 2015 Version Page 12 of 68 3 Installation of Telecardialys PC Software See the User Manual Telecardialys Software 37 063 V1 0 10 15 2015 Version Page 13 of 68 4 Bluetooth pairina procedure of the Cardialys to a PC Windows XP Windows Vista Windows 7 and above External External adapter External adapter Internal module External External adapter Internal module module Installation CD Installation CD Nothing to do Insert adapter Nothing to do SXXX SXXX Internet is Specific it is essential to follow the appropriate procedure for the operating The pairing procedure of the Cardialys ECG with a PC running Windows 7 and above system of your PC 10 15 2015 Version Page 14 of 68 User Manual Cardialys 4 1 Windows XP Operating System Pairing of Cardialys with a Windows XP PC The Bluetooth USB adapter is pre associated by us with your Cardialys Use the following procedure in the following cases a you change your Bluetooth USB adapter b you do not use the supplied adapter to the benefit of an internal Bluetooth module c you use another Cardialys with the same adapter potential After Sales return Insert the USB Bluetooth adapter into an USB port on the PC then run the installation CD If the CD does not run automatically please run it manu
30. n should I charge Cardialys The Cardialys charge level is indicated by the ON OFF LED on the case of the device Cardialys battery life is short and you should ensure you pay close attention to the color code below Battery ON OFF LED GREEN sufficient battery level ORANGE insufficient battery level RED discharged battery WE RECOMMEND CHARGING THE DEVICE AS SOON AS THE INDICATOR BECOMES ORANGE AND BEFORE THE BATTERY BECOMES FULLY DISCHARGED 10 15 2015 Version Page 11 of 68 User Manual Cardialys Viewing and or transmission of the trace on a PC 2 5 ECG reading Following capture the data is sent to the PC automatically via the Bluetooth radio link which has a free field range of approximately 100 meters This requires the presence of a Bluetooth USB adapter supplied in the kit connected to the PC used to operate Cardialys On the operating PC the Telecardialys software See the User Manual Telecardialys Software 37 063 V1 0 is used to dialogue with the equipment via Bluetooth display the captured ECGs print the ECGs in several report modes send the captured ECGs by e mail archive and view the captured ECGs Capture Reading Transmission Interpretation Wireless b Cs Bluetooth transmission GSM Bluetooth phone Wirel ph na Internet GPRS Bluetooth Satellite transmission ECG captured with PC equipped with Bluetooth device Marine Medical Consultation Centre Telecardia ou Cardia
31. ne Warranty and After Sales Service The Customer agrees to comply with the Warranty Conditions listed on the Warranty Certificate accompanying the Equipment The Equipment is supplied with a one year 1 warranty during which period the Customer will be able to exchange Equipment found to have a latent defect and subject to the Customer having informed PARSYS Telemedicine thereof in writing and in detail In the event of a functional fault or failure of the Equipment the Customer may contact PARSYS Telemedicine by sending an e mail to support parsys com or by calling the PARSYS Telemedicine After Sales Service o Monday to Friday 10 a m 12 30 p m and 2 p m 6p m except for bank holidays o at 33 0 1 60 31 51 71 or by sending a letter by recorded delivery with acknowledgement of receipt to PARSYS Telemedicine After Sales Service 5 7 avenue de Paris 94300 Vincennes FRANCE The PARSYS Telemedicine After Sales Service identifies the nature of the fault or failure of the Equipment before carrying out any repairs or replacing the defective Equipment Beyond the warranty period the Customer has the possibility of subscribing to a maintenance contract with the PARSYS Telemedicine sales department 10 15 2015 Version Page 68 of 68
32. ors or wire to connect the 2 charging contacts under Cardialys and hold in contact for 1 second place the equipment back on the charger and wait for the Charger indicator to come on connect in settings mode to update the internal real time clock stop then restart the instrument 10 4 Metrological checks The instrument shall undergo metrological checks after 1 year maximum and these must be carried out by the PARSYS Telemedicine technical department it alone being able to guarantee maintenance of the instrument s metrological performance throughout its life cycle 10 5 Processing of out of use equipment In accordance with directive 2002 96 EC relating to waste electrical and electronic equipment WEEE the device must not be disposed of with household waste and must be taken to a specialist waste collection centre 10 15 2015 Version Page 65 of 68 11 Users Training Users of the Cardialys ECG must have kind of medical knowledge of physician nurse or first aider hold the associate degree have been trained on this medical device 10 15 2015 Version Page 66 of 68 12 Fault or failure 12 1 The Cardialys ECG does not send any trace After capturing the ECG no trace is received by paired PC the Bluetooth connection is most certainly lost We therefore advise you N NEVER ATTEMPT any direct manipulation on the PC Contact the PARSYS Telemedicine After Sales Service 12 2 The ECG is subject to
33. ou log on Click on Finish 10 15 2015 Version Page 39 of 68 Open the Program Files folder 32 bit processors or Program Files x86 64 bit processors User Manual Cardialys Accueil Partage Affichage By X Couper me Xx p Nouvel l ment 7 E Ouvrir _ i Copier le chemin d acc s i E Acc s rapide 7 a Modifier Copier Coller _ D placer Copier Supprimer Renommer Nouveau Propri t s a Coller le raccourci vers X dossier x Historique Presse papiers Nouveau Ouvrir v fF gt CePC gt Disquelocal C Program Files x86 Parsys s om j odifi le e aille R Favoris ON Modifi Typ Taill socket 3 ension de l app o WG Bureau socket dll 11 06 2015 14 33 Extension de l app 552 K E Emplacements r cer S sqimdb dil 11 06 2015 14 32 Extension de l app 78 Ko B T l chargements Q tcf exe 11 06 2015 14 34 Application 100 Ko tcgprint exe 11 06 2015 14 35 Application 117 Ko 9 Groupe r sidentiel a tcgtocsv exe 11 06 2015 14 37 Application 25 Ko A seb Walicki a tcgtojpg exe 11 06 2015 14 35 Application 159 Ko a tcgtoxml exe 11 06 2015 14 35 Application 158 Ko M CePC Bo Sara QE N 4 2 A Pa ali o MG tcp exe 11 06 2015 14 37 Application 268 Ko a Reseau ae B telecardialys exe 11 06 2015 14 38 Application 5519 Ko tk00 dll 11 06 2015 14 31 Extension de l app 239 Ko tkOa dll 11 06 2015 14 32 Extension de l app 70
34. re ECG Position the peripheral electrodes aVR aVL and the Neutral 10 15 2015 Version Page 49 of 68 Capture ECG Check the good connection between the differentiator and the wire electrodes cable Normally held together by a clamp Capture ECG Press the ON button on the differentiator until the eip comes on 10 15 2015 Version Page 50 of 68 Capture ECG The patient should remain CALM and RELAXED during capture Capture ECG H od the differentiator unit to indicate that the RADIO LINK is ESTABLISHED 10 15 2015 Version Page 51 of 68 Capture ECG The ECG trace is automatically sent to the terminal Personal Computer or Touchscreen Tablet Capture ECG There is no need to switch the differentitator off after capture 10 15 2015 Version Page 52 of 68 6 2 Cardialys in Preview mode The electrocardiograph ECG Cardialys in Preview mode allows the user to preview a simultaneous 12 or 18 lead ECG depending on options selected and then to capture an ECG trace To start the Preview and make an ECG capture we recommend that 1 Startthe Preview on the software 2 Follow the instructions below ECG Preview The patient should be BARE CHESTED The ECG can be captured with the subject in the HALF SITTING or LYING position NEVER STANDING We advise removing watches from wrists mobile phones from pockets 10 15 2015 Version Page 53 of 68
35. ry 91 Hard Version 00 10 nn Message Version NM Seriar D13050077 Local Device 17 40 04 BlueTooth neighbourhood Inquiry i 17 40 10 8 BlueTooth device s seen Remote Device 17 43 16 Discovery of device s profile s 17 43 18 D13050077 1 profile s found 17 43 18 MS SPP dient 00 19 86 00 03 9C is now connect Amplitude sensibility ONEMV 17 43 19 1 Adding Device Cardialys a 17 43 19 1 Current time is 02 11 2015 at 17 43 19 nine icone pisse 17 43 19 1 Read request of configuration v 2 Nr bytes compressed 17 43 19 1 Serial Number D13050077 5 17 43 19 1 Mac Address 00 71 CC 4E FF 1E Recording eng 17 43 19 1 Read request of configuration v 2 17 43 19 1 Read of configuration completed Modem Initialisation GPRS UDP Click on Remote Mac Address Then click on Write to save the new MAC address Action Edit BlueTooth Languages O Remote Mac Address 00 71 CC 4E FF 1E 17 40 04 BlueTooth neighbourhood 17 40 10 8 BlueTooth device s seen 17 43 16 Discovery of device s profile s 17 43 18 D13050077 1 profile s found 17 43 18 MS SPP dient 00 19 86 00 03 9C is now connect 17 43 19 1 Adding Device Cardialys 17 43 19 1 Current time is 02 11 2015 at 17 43 19 17 43 19 1 Read request of configuration v 2 17 43 19 1 Serial Number D13050077 17 43 19 1 Mac Address 00 71 CC 4E FF 1E dya mala 17 43 19 1 Read request o
36. sed in the electromagnetic environment specified below The client or user of the device must ensure that the device is used in such environment Immunity trials Trial level Conformity Electromagnetic environment CEI 60601 level directives Electrostatic shocks ES 6 kV in contact Conforms Floors must be made of wood concrete or 8 kV in the air ceramics If the floors are topped with CEI 61000 4 2 synthetic materials it is important that the relative humidity remains at 30 at least Magnetic field at the rate of the Conforms Magnetic fields at the rate of the electric electric network 50 60 Hz network must have the distinctive levels of a representative place located in a CEI 61000 4 8 commercial or hospital environment 10 15 2015 Version Page 61 of 68 PARSYS User Manual Cardialys Table 3 Directives and MANUFACTURER S statement electromagnetic IMMUNITY For all DEVICES and EM SYSTEMS Directives and manufacturer s statement electromagnetic emissions The device is made to be used in the electromagnetic environment specified below The client or user of the device must ensure that the device is used in such environment Trial level Conformity CEI 60601 level Electromagnetic environment directives The portable and mobile RF communicating devices should be not used nearer of any part of the medical devices including cables than the recommended separation distance calculated from the transmit
37. ted Direct Modem Initialisation GPRS UDP Click on Disconnect 00 07 80 51 E4 22 17 40 04 BlueTooth nei neighbourhood Inquir 17 40 10 8 BlueTooth device s seen Back to the start window of the TCP software Close the window to exit 10 15 2015 Version Page 45 of 68 5 Using Telecardialys PC Software See the User Manual Telecardialys Software 37 063 V1 0 10 15 2015 Version Page 46 of 68 6 ECG capture 6 1 Cardialys in Direct mode The electrocardiograph ECG Cardialys in Direct mode allows the user to capture a simultaneous 12 or 18 lead ECG depending on options selected To make an ECG capture we recommend that 1 Start the capture on the software 2 Follow the instructions below Capture ECG The patient should be BARE CHESTED The ECG can be captured with the subject in the HALF SITTING or LYING position NEVER STANDING We advise removing watches from wrists mobile phones from pockets 10 15 2015 Version Page 47 of 68 Capture ECG Place the precordial electrodes from V1 to V6 according to the recommendations of use Capture ECG With a 18 Lead cable Position the V3R V4R and V5R electrodes symmetrically from V3 V4 and V5 V5R can also be positioned in VE according to practice 10 15 2015 Version Page 48 of 68 Capture ECG With a 18 Lead cable Cc Position the V7 V8 and V9 electrodes on the subject s back Captu
38. ter frequency applicable equation Recommended separation distance d 1 2VP RF conducted disturbances 3 Veff CEI 61000 4 6 from 150kHz to 80MHz d 1 2VP from 80MHz to 800MHz d 2 3VP from 800MHz to 2 5GHz RF radiated disturbances 3 V m A where P is the maximum output power of the transmitter in CEI 61000 4 3 from 80 to 2 5GHz watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m of separation It should that field strengths from fixed RF transmitters as determined by an electromagnetic survey on site should be less than the compliance level in each frequency range Interferences may occur in the vicinity of equipment marked with the following symbol e a NOTE 1 to 80MHz and to 800MHZ the higher d range frequency applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM FM radio and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters it should be considered to proceed to an electromagnetic survey on site If the measured field strength in the location where the medical device is used exceeds the applicable RF
39. to communicate the name of the stack provider to the PARSYS Telemedicine After Sales Service before any installation N In the latter case we recommend not to try the installation before obtaining confirmation procedure by the PARSYS Telemedicine After Sales Service 10 15 2015 Version Page 26 of 68 User Manual Cardialys 4 2 2 Pairing of Cardialys with a Windows 7 PC Insert the USB Bluetooth adapter into an USB port on the PC then run the installation CD If the CD does not run automatically please run it manually in Windows Explorer Install BlueTooth O Device Install Parsys Software Install PDFCreator Software Quit installation PARSYS Do nothing until this window appears Click on Install Bluetooth Device Welcome to the InstallShield Wizard for WIDCOMM Bluetooth Software 5 5 0 9200 The Install5hield R Wizard will install WIDCOMM Bluetooth Software 5 5 0 9200 on your computer To continue click Next WARNING This program is protected by copyright law and international treaties j Cancel Click on Next gt 10 15 2015 Version Page 27 of 68 User Manual Cardialys i WIDCOMM Bluetooth Software 5 5 0 9200 License Agreement Please read the Following license agreement carefully END USER LICENSE AGREEMENT THE SOFTWARE ACCOMPANYING THIS END USER LICENSE AGREEMENT THE SOFTWARE IS LICENSED TO YOU ONLY ON THE CONDITION THAT YOU ACCEPT ALL OF THE TE
40. tooth Serial Port Network Access Dial up Networking File Transfer Fax PIM Synchronization Hands free Audio Stereo Audio Audio Gateway Find Devices Explore My Bluetooth Places Add a Bluetooth Device Bluetooth Configuration VV FF AE OS PC HO Quick Connect Stop the Bluetooth Device Click on Quick Connect then on Bluetooth Serial Port then on Find Devices 10 15 2015 Version Page 19 of 68 10 15 2015 Version User Manual Cardialys Bluetooth Device Selection Select a device Remote devices must be in Discoverable mode for this computer to find them For assistance in making 4 remote device discoverable refer to the remote device s documentation ADANTENY ADANTENY F B07030334 B07050006 60705001 7 2 2 ee 607050132 607050254 3 SEE If the device you are looking for is not in the list verify that the device has power and is operational On some devices you must press the Connect button to make the device discoverable Open the drop down menu Show devices and select Show all devices PARSYS TELEMEDECINE 260 4 H 118 avenue de France 35 C F 75013 PARIS support parsys com PING p mEes S N D07050001 0459 LULU Cardialys 25 005 V1 1 Turn back the Cardialys box Note the device ID S N on its label Number starting with D Page 20 of 68 User Manual Cardialys Make the connection Hold down t
41. ts at the base of the device using a special charger Man Machine Interface o On Off push button on the front o blue LED for Bluetooth link o green orange red LED indicating power on and battery status respectively gt 100 20 gt bat gt 5 lt 5 Automatic shut down after one minute of inactivity BF type applied part protected against defibrillation shocks Protection against water ingression ordinary 9 3 Electrical specifications Supply voltage 2 5v to 4 3v DC Consumption 170mA 3 8v type during capture 200 mA 3 8v typ during connection 16 bit scanning 500 Hz sampling frequency 18 simultaneous leads Bandwidth 0 05 Hz gt 40 Hz Voltage input range 5mV Input impedance 10MQ Protected against defibrillation shocks SPP profile class 1 2 0 EDR Bluetooth radio link 10 15 2015 Version Page 64 of 68 10 Maintenance 10 1 Cleaning Disinfection The machine can be cleaned and disinfected by wiping the plastic unit with cotton wool or a wipe soaked in a product such as STERANIOS or equivalent 2 glutaraldehyde solution 10 2 Procedure in the event that the instrument is dropped or falls Mechanical damage to the instrument necessarily implies discontinuation of use of the machine and return to the PARSYS Telemedicine After Sales Service 10 3 Reset procedure If when using the instrument it blocks for more than 1 min use the reset cable or a metallic object paper clip pair of sciss
42. ure and transmit an ECG trace to a PC with the supplied software Telecardialys configured in Preview mode preview of the ECG trace then capture of an ECG trace 2 2 3 Starting Stopping the device The device is switched on by pressing the button on the front of the case for a few seconds until the ON OFF LED goes out ON OFF button Turn off in Direct mode The Cardialys automatically turns off after transmission of the ECG trace to the PC Turn off in Preview mode Turn off the Cardialys by holding down the ON OFF button until the LED stops flashing The shutdown sequence is automatic you can release the button 10 15 2015 Version Page 8 of 68 2 3 Patient cable The patient cable connects to Cardialys using the DB25 plug at the top of the instrument The cable comes with 2 end fittings and in 2 types according to the number of leads to be acquired with banana plug in 12 or 18 lead model with 4 mm clip for adhesive electrodes in 12 or 18 lead model The selection must be made at the time of purchase of the instrument The operating PC software nevertheless makes it possible to select just 12 leads when using an 18 lead cable 10 15 2015 Version Page 9 of 68 2 4 Charging system 2 4 1 Charger use Cardialys is equipped with a separate power supply provided by a rechargeable Lithium Polymer battery allowing approximately 50 traces per charge This battery is recharged using the charger via 2 metal contacts integrat
43. y using the transmitter frequency applicable equation where P is the characteristic of the transmitter maximum transmission power in watts W according to its manufacturer NOTE 1 to 80MHz and to 800MHz the higher d range frequency applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 10 15 2015 Version Page 63 of 68 9 Technical features 9 1 Individual recording characteristics ECG traces 2 second pitch adjustable length in TeleCardia mode of ordinary length 1 second pitch in PC direct reading monitoring mode Number of leads for selection prior to capture 12 18 ECG timestamping Patient identification Identification of the device and the embedded Software version used to make the recording 9 2 General features Type class 2A ECG 12 18 lead device for temporary use Space requirements 130x70x25mm not including patient cable Weight 110 g patient cable 310 g in the 18 lead version Plastic case ABS 26 arbour finish Patient cable interface 25 pin SUB D High mechanical endurance Power supply Lithium Polymer 3 7V 750mAh rechargeable battery power supply replacement part available from the PARSYS Telemedicine After Sales Service Battery life cycle 3 years life cycle Operating temperature range 10C 7 35 C Storage temperature range 10 C 60 C Charging by the charging contac
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