the User Manual Telecardia
Contents
1. 20 06 19 BlueTooth neighbourhood Inquiry oe 20 06 26 device s seen ea Cydic Storage Hetero Filtering 20 06 32 Tooth neighbourhood Inquiry 20 06 40 13 BlueTooth device s seen vocal Deg Electrodes Test 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found z 20 06 58 MS SPP dient 00 19 86 00 03 9C is now conneci Modem Initialisation GPRS UDP 20 06 58 1 Adding Device TeleCardia 20 06 58 1 eee 06 58 20 06 59 1 Serial Number TO 20 06 59 1 Mac Address eee 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed Click on Configuration Then click on Write to save all the changes 10 15 2015 Version Page 45 of 72 User Manual Telecardia TO7050343 00 07 60 62 40 46 SerialNr _ T07050343 Remote Mac Address v 40 16 7E 3C 24 88 Max Number of ECG 10 M Cydic Storage V Hetero Filtering geg Inquiry _ Vocal Messages _ Electrodes Test 20 06 40 13 BlueTooth device s seen re 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found 20 06 58 MS SPP client 00 19 86 00 03 9C is now connect 20 06 58 1 Adding Device TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 20 06 59 1 Serial Number T07050343 20 06 59 1 Mac Address 40 16 7E2. T07050343 40 16 7E 3C 24 B8 20 06 19 BlueTooth neighbourhood iry Max Number of ECG In Inquir 20 06 26 ea te device s seen M Cydic Storage V Hetero Filtering 20 06 32 TOO j i Electr 20 06 40 13 BlueTooth device s seen Vocal EE O BEES 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found 20 06 58 MS SPP dient 00 19 86 00 03 9C is now connect y Modem Initialisation GPRS UDP 20 06 58 1 Adding Device TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 8 Er TTT 20 06 59 1 Serial Number 107050343 Cardialys MacAddress 20 06 59 1 Mac Address 40 16 7E 3C 24 B8 Pre identification Zone v 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast Click on Remote Mac Address Then click on Write to save the new MAC address Battery 77 Disconnect Message Version 02 03 FR Serialr _ T07050343 Remote Mac Address v 40 16 7E 3C 24 88 Cydic Storage 20 06 40 13 BlueTooth device s seen vocal DEE 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found 20 06 58 MS SPP client 00 19 86 00 03 9C is now connect Modem Initialisation 20 06 58 1 Adding Device TeleCardia 20 06 58
3. 74 Ko wbtsowl dil 11 06 2015 14 33 Extension de l app 456 Ko amp 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 Call Client i gon port 06 ocal Device FLT Remote Device Start HANDSHAKE Crtl B When the software is opened set the device Call Client mode 10 15 2015 Version Page 40 of 72 Open the Telecardia housing Note the ID of the used device Number starting with a T OUT button ON button Make the connection Simultaneously press the ON and OUT buttons until the device s ignition 10 15 2015 Version Page 41 of 72 User Manual Telecardia TOFI 00 07 80 8 20 06 19 BlueTooth nei Inquiry 20 06 26 10 BlueTooth device s seen 20 06 32 BlueTooth nei Inquiry 20 06 40 13 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 amp T07050343 00 07 80 82 40 46 20 06 19 BlueTooth neighbourhood Inquiry 20 06 26 10 BlueTooth device s seen 20 06 32 BlueTooth neighbourhood i 20 06 40 13 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 72
4. Disinfection The Telecardia machine can be cleaned and disinfected by wiping the electrodes in contact with the skin and the plastic unit except on the self adhesive label at the rear of the machine with cotton wool or a wipe soaked in a product such as STERANIOS or equivalent 2 glutaraldehyde solution Any other product would not ensure proper cleaning without damaging the Telecardia components 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 device it blocks for more than 1 min Use the reset cable or take a metal object paper clip and place it on the charging contacts for 1s Place the equipment back on the charger and wait for the Charger indicator to come on Establish radio connection with the PC in configuration mode in order to update the device s internal real time clock Open the cover as shown on the photo press and hold the OUT button and press on the GREEN ON OFF button at the same time OUT button When the machine displays PARSYS Sant release both buttons The machine then indicates the time and date before displaying en cours in progress and connexion BT BT connection Restart the device 10 15 2015 Version Page 67 of 72 PARSYS User Manual Telecardia 10 4 Metrologic
5. Do nothing until this window appears Click on Install Bluetooth Device 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 10 15 2015 Version Page 38 of 72 User Manual Telecardia Use Bluetooth hands free devices to do calls over Skype or other VolP applications Wait until the installation completes Installation Complete Thank you Some of the Bluetooth functionality might not be available until the next time you log on Click on Finish 10 15 2015 Version Page 39 of 72 User Manual Telecardia P S TELEMEDECINE Open the Program Files folder 32 bit processors or Program Files x86 64 bit processors Outils d application x Accueil Partage Affichage Gestion A 8 A X Couper me F f F3 Nouvel l ment P E Ouvrir EE S lectionner tout iJ Copier le chemin d acc s Acc s rapide 7 Modifier So Aucun Copier Coler El Coller le raccourci geg Ger SE Game gemat pres Historique Be Inverser la s lection Presse papiers
6. Program Files folder 32 bit processors or Program Files x86 64 bit processors Ak XK amp A Accueil Partage P X Couper MJ Copier le chemin d acc s Affichage E Ouvrir HI S lectionner tout Modifier F4 Nouvel l ment 7 Acc s rapide 50 Aucun oo a Coller le raccourci geng rei me a trane rt Dee D Historique Be Inverser la s lection Presse papiers Organiser Nouveau Ouvrir S lectionner fF A gt CePC Disque local C Program Files x86 Parsys v Ciy Rechercher d re CT Nom j Modifi le Type Taille E Bureau socket dll 11 06 2015 14 33 Extension de l app 552 Ko SE Emplacements r cer sqlmdb dll 11 06 2015 14 32 Extension de l app 78 Ko B T l chargements tcf exe 11 06 2015 14 34 Application 100 Ko tcgprint exe 11 06 2015 1435 Application 117 Ko Groupe r sidentiel CN tcgtocsv exe 11 06 2015 14 37 Application 25 Ko D seb Walicki a tcgtojpg exe 11 06 2015 14 35 Application 159 Ko a tcgtoxml exe 11 06 2015 14 35 Application 158 Ko IR Ce PC ins To mess zb R seau wen wm telecardialys exe 11 06 2015 14 38 Application 5519 Ko 3 tk00 dil 11 06 2015 14 31 Extension de l app 239 Ko tkOa dll 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 S tkOc dll 11 06 2015 14 32 Extension de l app 160 Ko tkOd dil 11 06 2015 14 32 Extension de l app 308 Ko tk01 dil 11 06 2015 14
7. User Manual Telecardia a Tor 0503 sib 00 07 20 06 19 BlueTooth neighbourhood Inquiry 20 06 26 10 BlueTooth device s seen 20 06 32 BlueTooth neighbourhood i 20 06 40 13 BlueTooth device s seen Once the desired device is visible click its icon although check the serial number Then click on Choose ER Hard Version B201 07050343 00 07 80 82 40 4B Message Version 02 03 FR i 707050343 40 16 7E 3C 24 B8 Cydic Storage Hetero Filtering _ Vocal Messages _ Electrodes Test 20 06 48 Discovery of device s profes i _ Pre Identification 20 06 57 T07050343 1 profile s found 20 06 58 MS SPP dient 00 19 86 00 03 9C is now connect i y Modem Initialisation GPRS UDP 20 06 58 1 Adding Device TeleCardia eee ee eee EENG 20 06 59 1 Serial Number T070 EE 20 06 59 1 Mac Address eg EE Pre identification Zone 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast The interface window with the medical device is then visible 10 15 2015 Version Page 43 of 72 User Manual Telecardia T07050343 00 07 60 62 40 46 T07050343 40 16 7E 3C 24 B8 fe als Sie eet vue Led Device Ctri L Max Number ofECG 10 20 06 26 10 BlueTooth device s seen REMOTE Denem 4 Cycic Storage Y Hetero Fitering 20
8. in progress and connexion BT BT connection Restart the device 12 5 The Telecardia ECG has lost is time stamping If your Telecardia ECG has lost is time stamping Establish radio connection with the PC in configuration mode in order to update the device s internal real time clock Open the cover as shown on the photo press and hold the OUT button and press on the GREEN ON OFF button at the same time OUT button ON button When the machine displays PARSYS Sant release both buttons The machine then indicates the time and date before displaying en cours in progress and connexion BT BT connection Restart the device 10 15 2015 Version Page 71 of 72 PARSYS User Manual Telecardia 13 PARSYS Telemedicine 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 holi
9. A 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 5 of 72 PARSYS User Manual Telecardia 2 Equipment description 2 1 Overview Telecardia represents a major advance in remote cardiac monitoring and portable medical equipment It enables health professionals to rapidly capture and send a patient s ECG under any circumstances without the constraints of a conventional device The trace captured is a digital simultaneous 12 lead 12 tracing ECG in keeping with standard electrocardiographs usually used It can be sent automatically to a care watch centre or be viewed on a PC next to the patient Telecardia has CE marking CE0459 This is an ECG device intended for temporary use class lla 2 2 Electrodes position Neutral Telecardia is an electrocardiograph simultaneous 12 lead 12 channel with fixed thoracic electrodes with dry electrodes noconsumables 2 2 1 Precordial leads v1 1 Precordial leads The shape of the unit enables capture of the 6 precordial leads collected thanks to the 2 articulated arms These thoracic electrodes are dry and fixed from V1 to V6 The Neutral usually captured on the right leg is captured in the thorax via the fixed electrode on the housing see figure 1 10 15 2015 Version Page 6 of 72 User Manual Telecardia 2 2 2 Peripheral leads 2
10. 003 1 User Manual Telecardia EN Ref 37 021 1 Warranty Card EN Ref 37 003 If any of the items are missing please contact us at the address specified in this manual 10 15 2015 Version Page 3 of 72 PARSYS User Manual Telecardia 1 2 List of symbols used Warning consult attached documents Please read the notice E 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 Device climatic range of use or storage S N Serial number C Medical device European compliance 10 15 2015 Version Page 4 of 72 PARSYS User Manual Telecardia 1 3 Warnings PARSYS Telemedicine draws the attention of the user on the following points regarding A The device must not be used simultaneously with an electric surgery tool A The device is not intended for cardiac direct use reserved to CF class devices A The ECG capture must not be performed when the device is charging on its charging base A When the ECG is capturing electrodes unplugged on the patient must not come into contact with the ground or other exposed metal parts A When the ECG is capturing the device s differentiator box must be in contact with the patient A 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
11. 06 32 Tooth neighbourhood Inquiry 20 06 40 13 BlueTooth device s seen Vocal EE Electrodes Test 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 707050343 1 profile s found Connection Mode 20 06 58 MS SPP dient 00 19 86 00 03 9C is now connect Direct y Modem Initialisation GPRS UDP 20 06 58 1 Adding Device TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 8 SS TTT 20 06 59 1 Serial Number 107050343 Cardialys MacAddress 20 06 59 1 Mac Address 40 16 7E 3C 24 B8 Pre identification Zone 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast x Click on Remote Mac Address Then click on Local Device The PC MAC address will be registered Hard Version 02 01 Message Version 02 03 FR T07050343 40 16 7E 3C 24 B8 Local Device Number z 20 06 19 BlueTooth neighbourhood Inquiry y geng BEER o 20 06 26 10 BlueTooth device s seen Remote Device Cydic Storage Hetero Filtering 20 06 32 BlueTooth neighbourhood Inquiry 20 06 40 13 BlueTooth device s seen L vocal EE Electrodes Test 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found 20 06 58 MS SPP dient 00 19 86 00 03 9C is now connect z v Modem Initialisation GPRS UDP 20 06 58 1 Adding Devi
12. 2 2 1 2 lead peripheral Patient cable model With the 2 lead model Telecardia contains 1 rolling wire electrode located under the device left arm for the AvF lead 2 Dry wire electrode for AVF 3 Patient cable connecting 1 cable to plug on the Telecardia box right side capturing AVR and AvL with expandable bracelets or limb clips dry electrodes see figure 4 and 5 BW AvR AvL AL 4 Cordon Patient AVR amp AvL Patient cable 5 Expandable bracelets or limb clips dry electrodes 10 15 2015 Version Page 7 of 72 User Manual Telecardia 2 2 2 2 3 lead peripheral Patient cable model With the 3 lead model Telecardia contains a Patient cable to plug into the ECG box right side It enables the capture of AVR AvL and AvF with limb clips dry electrodes see figure 6 AvL ET N AvR 6 Peripherals cable AvR AvL and AvF Limb clips electrodes 7 Peripheral cable connection The insertion mark a red point on the cord must be facing the device s top 10 15 2015 Version Page 8 of 72 2 3 Device control buttons To control the machine and start all the functions Telecardia has 2 buttons 1 button used to release the arms and switch the machine ON OFF located on the front of the machine and marked with a green circle crossed by a black line 1 button used to access the machine s advanced functions located under the top cover and marked OUT In addition combinations of these buttons are used
13. 3C 24 B8 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed Click on Disconnect amp TO7050343 00 07 80 62 40 46 20 06 19 BlueTooth neighbourhood Inquiry 20 06 26 10 BlueTooth device s seen 20 06 32 BlueTooth nei i 20 06 40 13 BlueTooth device s seen Back to the start window of the TCP software Close the window to exit 10 15 2015 Version Page 46 of 72 PARSYS User Manual Telecardia 5 Using Telecardialys PC Software See the User Manual Telecardialys Software 37 063 V1 0 10 15 2015 Version Page 47 of 72 PARSYS User Manual Telecardia 6 ECG capture If you have the Telecardia ECG please follow the following procedures to capture a simultaneous 12 lead ECG trace on the patient Press the Start Telecardia ECG button on the software the message ECG waiting appears You can capture the ECG the trace will be automatically transmitted to the PC 6 1 2 lead peripheral Patient cable model Capture ECG NB For the sake of clarity the illustrations show a figure with no shirt However the subject does not have to take his her shirt off SHIRT OPEN SLEEVES UP is satisfactory The ECG can be captured with the subject SITTING or LYING DOWN NEVER STANDING UP Capture ECG Press briefly on the to open the ECG arms NEVER use force to open the arms 10 15 2015 Version Page 48 of 72
14. B8 Pre identification Zone y 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast g The interface window with the medical device is then visible Hard Version 02 01 Message Version 02 03 FR T07050343 40 16 7E 3C 24 B8 BS es NES 1 Jea oe D zeien o Local Device Ctrl L 20 06 19 BlueTooth neighbourhood Inquiry i geng BEER o 20 06 26 10 BlueTooth device s seen MOLE DEVICE 20 06 32 BlueTooth neighbourhood Inquiry 20 06 40 13 BlueTooth device s seen L vocal EE 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found 20 06 58 MS SPP dient 00 19 86 00 03 9C is now connect v Modem Initialisation GPRS UDP 20 06 58 1 Adding Device TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 F D 20 06 59 1 Serial Number T07050343 Cardiniys Machddress 20 06 59 1 Mac Address 40 16 7E 3C 24 B8 Pre identification Zone y 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast z Y Cydic Storage V Hetero Filtering _ Electrodes Test Click on Remote Mac Address Then click on Local Device The PC MAC address will be registered 10 15 2015 Version Page 33 of 72 User Manual Telecardia
15. 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 64 of 72 PARSYS User Manual Telecardia 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 transmitter 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 3 P from 800MHz to 2 5GHz RF radiated disturbances 3 V m CEI 61000 4 3 from 80 to 2 5GHz where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m of separation It should that field stren
16. PARSYS User Manual Telecardia Capture ECG Dampen the bracelets with the water spray Capture ECG Slip the bracelets over the subject s arms Follow the colour codes Ec for the RIGHT ARM YELLOW for the LEFT ARM Push the bracelets up as close to the elbow as possible to ensure good contact 10 15 2015 Version Page 49 of 72 PARSYS User Manual Telecardia Capture ECG Pull out the wire electrode under the right arm and completely unwind the wire metal ball Gently lodge the metal ball in the slot to stop it rewinding Capture ECG Dampen the chest and the wire electrode on both sides 10 15 2015 Version Page 50 of 72 PARSYS User Manual Telecardia Capture ECG Place the wire electrode on the LEFT hip bone the iliac crest in contact with the skin Use the subject s underwear elastic to hold it in position Capture ECG Connect the ECG bracelets cable in the socket on the LEFT side of the unit with the cable s RED mark pointing UP 10 15 2015 Version Page 51 of 72 PARSYS User Manual Telecardia Capture ECG H Place the ECG unit on the subject s chest with the BLACK arrow of the left arm aligned in the middle of the sternum The ECG unit s button should be level with the subject s LEFT nipple Capture ECG Keep the ECG unit I firmly pressed up against the chest in order to maintain the electrodes in contact with the skin 10 15 2015 Version
17. Page 52 of 72 PARSYS User Manual Telecardia Capture ECG Maintaining contact keep the button PRESSED DOWN until the audible signal a beep or a voice sounds and then release it to begin capture Capture ECG Exert gentle pressure on the arms and the top of the unit to keep the electrodes in contact with the skin Both you and the subject should stay as STILL and CALM as possible for the 15 seconds of capture An audible signal a beep or a voice sounds at the end of capture and automatic data transmission 10 15 2015 Version Page 53 of 72 PARSYS User Manual Telecardia 6 23 lead peripheral Patient cable model Capture ECG NB For the sake of clarity the illustrations show a figure with no shirt However the subject does not have to take his her shirt off SHIRT OPEN SLEEVES UP is satisfactory The ECG can be captured with the subject SITTING or LYING DOWN NEVER STANDING UP Capture ECG Connect the ECG cables to the limb clips following the colour codes Dampen the limb clips with the water spray 10 15 2015 Version Page 54 of 72 PARSYS User Manual Telecardia Capture ECG Slip the limb clips over the subject s arms Follow the colour codes A RED for the RIGHT ARM YELLOW for the LEFT ARM for the RIGHT arm for the LEFT arm Capture ECG Ki Ig Sip the limb clip over the LEFT leg 10 15 2015 Version Page 55 of 72 PARSYS User Manual Telecardia Capture E
18. Telecardia 3 Installation of Telecardialys PC Software See the User Manual Telecardialys Software 37 063 V1 0 10 15 2015 Version Page 12 of 72 PARSYS User Manual Telecardia 4 Bluetooth pairing procedure of the Telecardia 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 above is specific it is essential to follow the appropriate procedure for the operating The pairing procedure of the Telecardia ECG with a PC running Windows 7 and system of your PC 10 15 2015 Version Page 13 of 72 User Manual Telecardia 4 1 Windows XP Operating System Pairing of Telecardia with a Windows XP PC The Bluetooth USB adapter is pre associated by us with your Telecardia Use the following procedure in the following cases A 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 Telecardia 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 manually in Windows Explorer Install Parsys Software Install PDFCreator Software Quit installation PARSYS Do noth
19. gt ie Explore My Bluetooth Places PIM Synchronization gt Add a Bluetooth Device Hands free Audio b Bluetooth Configuration Stereo Audio gt Audio Gateway b Quick Connect Stop the Bluetooth Device Click on Quick Connect then on Bluetooth Serial Port then on Find Devices 10 15 2015 Version Page 18 of 72 User Manual Telecardia 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 fe SS g g ADANTENY ADANTENY F B07030334 B07050006 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 Open the Telecardia housing Note the ID of the used device Number starting with a T 10 15 2015 Version Page 19 of 72 User Manual Telecardia Make the connection Simultaneously press the ON and OUT buttons until the device s ignition 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 S E B B07050132 B07050254 CHARIO
20. to select the requested functions o S BR OUT button 4 Telecardia buttons 10 15 2015 Version Page 9 of 72 PARSYS User Manual Telecardia 2 4 Charging base Telecardia is equipped with a separate power supply provided by a rechargeable Lithium Polymer battery allowing approximately 50 traces per charge This battery is charged using the charging base via 2 metal contacts integrated in the back of the machine unit The charging base charges the machine completely in approximately 2 5 hours using a 220V 50Hz source via the mains adapter supplied IRREVERSIBLE DAMAGE NOT COVERED BY THE MACHINE WARRANTY IS LIABLE TO OCCUR A ALWAYS USE THE MAINS ADAPTER SUPPLIED TO POWER THE BASE OTHERWISE To charge Telecardia Connect your charging base to 220V power supply Put Telecardia upon its charging base CHECK LIGHT INDICATORS ON THE CHARGING BASE S SIDE TO CONFIRM THE GOOD CONTACT OF THE DEVICE WITH CHARGING CONTACTS Light indicators located on the side of the base indicate the machine charging status and whether the machine is in contact with the support Telecardia charging indicator On Off indicator The ON OFF indicator flashes BLUE to indicate that the base power is on The CHARGING INDICATOR does not light up when Telecardia is not correctly inserted in its slot without contact with the charging contacts or missing from the slot The CHARGING INDICATOR remains RED as long
21. 1 Current time is 25 06 2015 at 20 06 58 20 06 59 1 Serial Number 707050343 ne 20 06 59 1 Mac Address 40 16 7E 3C 24 B8 Pre identification Zone 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast In the field Max Number of ECG replace the number by 1 if you only want to do an ECG at a time This is preferable to avoid any mistake in ECG Patient assignments 10 15 2015 Version Page 34 of 72 User Manual Telecardia 20 06 19 BlueTooth neighbourhood Inquiry al BEES eg EE device s seen ae Cydic Storage Hetero Filtering 20 06 32 Tooth neighbourhood Inquiry 20 06 40 13 BlueTooth device s seen L vocal N Electrodes Test 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found e 20 06 58 MS SPP client 00 19 86 00 03 9C is now connect Modem Initialisation 20 06 58 1 Adding Device TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 20 06 59 1 Serial Number T07050343 20 06 59 1 Mac Address 40 16 7E 3C 24 B8 Pre identification Zone 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast g Click on Configuration Then click on Write to save all the changes 20 06 19 BlueTooth neighbourhood Inquiry A 20 06 26 de
22. 32 Extension de l app 290 Ko tk03 dil 11 06 2015 14 32 Extension de l app 67 Ko S tk04 dil 11 06 2015 14 32 Extension de l app 94 Ko S tkidll 11 06 2015 14 38 Extension de l app 3 709 Ko 3 twainmgr dll 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 wavecom dll 11 06 2015 14 32 Extension de l app 74 Ko wbtsowl dll 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 1 l ment s lectionn 267 Ko E Then open the Parsys folder and start the TCP EXE software 10 15 2015 Version Page 29 of 72 User Manual Telecardia Remote Device Start HANDSHAKE Crtl B When the software is opened set the device Call Client mode Open the Telecardia housing Note the ID of the used device Number starting with a T 10 15 2015 Version Page 30 of 72 Simultaneously press the ON and OUT buttons until the device s ignition 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 Make the connection TO7050343 00 07 80 82 40 46 20 06 19 BlueTooth neighbourhood Inquiry 20 06 26 10 BlueTooth device s seen 20 06 32 BlueTooth neig
23. 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 10 15 2015 Version Page 16 of 72 User Manual Telecardia 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 WwIDCOMM Bluetooth Software This may take several minutes Status Copying new files COC EEE EE CT SNS 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 17 of 72 User Manual Telecardia Explore My Bluetooth Places Add a Bluetooth Device Bluetooth Configuration Quick Connect Stop the Bluetooth Device Make a right click on the Bluetooth icon at the bottom right of the screen Send Business Card Bluetooth Serial Port gt Find Devices Network Access b Dial up Networking gt File Transfer b F
24. CG Press briefly on the button to open the ECG arms NEVER use FORCE to open the arms Capture ECG Connect the ECG limb clips cable in the socket on the LEFT side of the unit Gently turn the cable s RED mark pointing UP 10 15 2015 Version Page 56 of 72 PARSYS User Manual Telecardia Capture ECG Dampen the subject s chest with the water spray Capture ECG keet D 10 15 2015 Version Place the ECG unit on the subject s chest The BLACK ARROW of the left arm aligned in the middle of the sternum The ECG unit s button should be level with the subject s LEFT nipple Page 57 of 72 PARSYS User Manual Telecardia Capture ECG H Keep the ECG unit firmly pressed up against the chest in order to maintain the electrodes in CONTACT with the skin The ECG unit at a A slight angle Capture ECG I Maintaining contact keep the button pressed down 5 sec PRESSED DOWN until the audible signal a beep or voice sounds then RELEASE it to begin capture 10 15 2015 Version Page 58 of 72 PARSYS User Manual Telecardia Capture ECG s Keep the electrodes in J contact with the skin Both you and the subject should stay as STILL and CALM as possible for the 15 seconds of capture An audible signal a beep or a voice sounds at the end of capture and automatic data transmission 10 15 2015 Version Page 59 of 72 PARSYS User Manual Telecardia 7 Updat
25. LECARDIA ECG DOES NOT SEND ANY TRACE 70 12 2 THE ECG IS SUBJECT TO INTERFERENCE nus de eu 70 12 3 THE TELECARDIA ECG IS NOT CHARGING EN 70 12 4 THE TELECARDIA ECG REMAINS BLOCKED ruran rnranrnaranrnnnnnrnnnne 71 12 5 THE TELECARDIA ECG HAS LOST IS TIME STAMPING ccececcececececcecececueaececececaeaececucueaeaesecueutaeaesesetass 71 13 PARSYS TELEMEDICINE WARRANTY AND AFTER SALES SERVICE ccccscecescecescecescecesceeess 72 10 15 2015 Version Page 2 of 72 1 Kit contents We thank you for having chosen PARSYS Telemedicine equipment We hope that it will bring you full satisfaction in your daily electrocardiography practice 1 1 Components Firstly please check the contents of your Telecardia Kit Ref 100 004 It must contain the following items 1 Telecardia portable electrocardiograph ECG Ref 25 001 1 Bluetooth USB adapter Ref 36 002 1 Peripheral Patient cable depending on the model supplied v 2 lead 10 mm clips Ref 23 011 V1 1 v 2 lead 4 mm banana plugs Ref 23 011 V1 2 v 3 lead 4 mm banana plugs Ref 23 029 2 or 3 Adapters for Patient cable depending on the model supplied v 2 expandable bracelets 10 mm clips Ref 33 010 11 v 2or3arm limb clips 4 mm banana plugs Ref 36 007 8 1 1 1 Charging base DC 5V 1 1A Ref 25 002 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
26. Organiser Nouveau Ouvrir S lectionner gt fF gt CePC gt Disque local C Program Files x86 Parsys v Rechercher d dee C Nom Modifi le Type Taille A E Bureau 3 socket dll 11 06 2015 14 33 Extension de l app 552 Ko QE Emplacements r cer 3 sqlmdb dll 11 06 2015 14 32 Extension de l app 78 Ko B T l chargements E tcf exe 11 06 2015 14 34 Application 100 Ko E tcgprint exe 11 06 2015 14 35 Application 117 Ko EI Groupe r sidentiel E tcgtocsv exe 11 06 2015 14 37 Application 25 Ko D seb Walicki E tcgtojpg exe 11 06 2015 14 35 Application 159 Ko E tcgtoxml exe 11 06 2015 14 35 Application 158 Ko ll Ce PC 2 Gia R seau gen mt B telecardialys exe 11 06 2015 14 38 Application 5519 Ko S tk00 dll 11 06 2015 14 31 Extension de l app 239 Ko 3 tkOa dll 11 06 2015 14 32 Extension de l app 708 Ko tkOb dll 11 06 2015 14 32 Extension de l app 1194 Ko tkOc dll 11 06 2015 14 32 Extension de l app 160 Ko tk d 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 3 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 tki dil 11 06 2015 14 38 Extension de l app 3 709 Ko twainmgr dll 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 1446 Ko 3 wavecom dll 11 06 2015 14 32 Extension de l app
27. PARSYS Telemedicine 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 TELECARDIA 37 021 V4 0 Date of the first placing on the market of the product 01 03 2007 C o459 P S TELEMEDECINE 10 15 2015 Version PARSYS User Manual Telecardia SUMMARY 1 vdIRES ein NEEN 3 TA LOOM ONENT ed ea a de de ee ee se 3 1 2 LIST OF SYMBOLS USED narar annaran naL A LALEA AEE DECELAR EAREPACELEREAEAEEC ECA RAAEREA CE CEREA EAER A Canan ann 4 1 3 WARNINGS cccccecccceccceccceccccececcecuccecucaecueuucecuececusecuucecsenecseaucauuuucuusecsunecsunesseaesseeseceusecsuuessuaessuaeceuaeeas 5 2 EQUIPMENT DESCRIRUION stousse eege 6 2A e lt Te 6 2 2 ELECTRODES POSITION 6 221 ee ET RE e LEE 6 222 Fenph ral EE 7 23 DEVICE CONTROLBUTTONS EEN 9 COIN RE ev ee ee ee Te P e a 10 PASER sO READING eege ee ee eo 11 INSTALLATION OF TELECARDIALYS PC GOETWARE sek ENKEN RENE ENKEN KENE RK ENKEN KN 12 BLUETOOTH PAIRING PROCEDURE OF THE TELECARDIA TO A PC 2 cc cccececcecescscescscncescnseseneeees 13 4 1 WINDOWS XP OPERATING GNSTEN arrana rruna rrara oranana nnana n annara nran anr ane 14 4 2 WINDOWS 7 OPERATING DYVSTEM 25 4 2 1 Ee et ee Te ee eT bien tt one meet is nn 25 4 2 2 Pairing of Telecardia with a Windows ZP 26 4 3 WINDOWS 8 8 1 OPERATING DGYSTEM arrana rrnr anran anrnr
28. T ORDI VALIDA PC SEB a Station test 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 Telecardia and click on Next gt If necessary click on Search Again 10 15 2015 Version Page 20 of 72 User Manual Telecardia Bluetooth Security Setup Bluetooth Pairing Paired devices exchange a secret key each time they connect This key is unique for each pair of devices it is used to verify identity and to encrypt the data thatthe os 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 E T07 Ga Pairing Pairing starts with Telecardia Bluetooth Security Setup Bluetooth Pairing Paired devices exchange a secret key each time they connect This key is unique at for each pair of devices it is used to verify identity and to encrypt the data that the Qos devices exchange To complete the pairing process type the required passkey and then click Next If you da not know the passkey see the instructions that E T 7 S Enter the pairing passkey The installer asks for a passkey Type the code 02101124 and click on Next gt 10 15 2015 Vers
29. agnetic 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 ran 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 The charging power box catalogue product must Harmonic Emissions l Non applicable solely be used with the device in sleep mode CEI 61000 3 2 disconnected from the patient Pulse fluctuations donaoolicaoie Flicker CEI 61000 3 3 ai 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 used 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
30. al checks The device shall undergo metrological checks after 1 year maximum Checks should be carried out by the PARSYS Telemedicine technical department it alone being able to guarantee maintenance of the device s metrological performance 10 5 Discharged battery We recommend not to let Telecardia discharged for more than 1 year to keep the device s internal real time clock 10 6 Product scrap treatment According to the directive 2002 96 CE relating to DEEE electronic and electric devices do not throw away in regular trash Please bring waste to specialized collection points 10 15 2015 Version Page 68 of 72 PARSYS User Manual Telecardia 11 Users Training Users of the Telecardia 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 69 of 72 PARSYS User Manual Telecardia 12 Fault or failure 12 1 The Telecardia 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 A NEVER ATTEMPT any direct manipulation on the PC Contact the PARSYS Telemedicine After Sales Service 12 2 The ECG is subject to interference Check that the capture protocol described in section 6 has been followed in particular that the correct color code has been followed for the limb clips red on the r
31. anran 37 4I peguen S RS a ee nn de en ne D ne de li 37 4 3 2 Pairing of Telecardia with a Windows 8 8 1 PC 38 USING TELECARDIALYS PC GOETWARE see ENKEN ERKENNEN KREE KENNEN ENKEN ENKEN ENKEN 47 ECG CAPTURE EEN 48 6 1 2 LEAD PERIPHERAL PATIENT CABLEMODEL 48 6 2 3 LEAD PERIPHERAL PATIENT CABLEMODEL 54 UPDATING THE PC SOFTWARE DEVICE FIRMWARE cccccceccsceccsceccscecescecescscnseeenseeeaseseneeess 60 TECHNICAL FEATURES 7 0 1 2 cccecceesscececnecnenecnenscsenscnenscneesnensnncnenscnenscnensenensenensnensesenensenensenensenensenenss 61 SNE ee Rat BT 61 8 2 MECHANICAL FEATURES viracviccscdconndauatstesnusssouecucedexewarSoanedauabiteanursouaouoveesevadieaniedauabslennseassacuiieedavucieaniedanadaxce 61 8 3 ELECTRICAL SPECIFICATIONS EE 61 8 4 FUNCTIONAL E BEES 62 85 FUNGTONAL FLOW e E EEN 63 9 ELECTROMAGNETIC EMISSIONS cccccccceccecescsceccececeececeecncescecnsceenseeeaseseaseseueeseueesenenseeensesenseseneness 64 10 NN E 67 10 1 CLEANING DISINFEECTION 67 10 2 PROCEDURE IN THE EVENT THAT THE INSTRUMENT IS DROPPED OR EALLS 67 10 3 RESET PROCEDURE EE 67 10 4 METROLOGICAL CHECKS wicicinenontitesanivaiadcuausedduniedheiisnontadesanivabaddenieedwendddeaisnontadesaalvadaddiuannedienddheatseontatesnaix 68 10 5 DISCHARGED ep NEE 68 10 6 PRODUCT SCHAPRTREATMENT nunnur anana aranana REPA L ALARE AEE LALALALA AEREO ELERE AEAEE E ALELA nannan nnt 68 KWR Ley ST Il Le EEN 69 12 FAULT OR FAILURE eege eege eege Eege 70 12 1 THE TE
32. as Telecardia is charging The CHARGING INDICATOR is GREEN when Telecardia is charged A Not charging Telecardia for more than 1 year means losing the instrument s internal real time clock we recommend to regularly charge Telecardia battery 10 15 2015 Version Page 10 of 72 User Manual Telecardia 2 5 ECG reading Viewing and or transmission of the trace on a PC 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 Telecardia 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 gt S Bluetooth transmission GSM Bluetooth phone Wirel pka na Internet GPRS Bluetooth Satellite transmission ECG captured with PC equipped with Bluetooth device Marine Medical Consultation Centre T l cardia ou Cardialys Reading Printing Sending PARSYS ECG reading centre Cardiologist or dedicated centre Wireless S gt Bluetooth transmission Charging base 10 15 2015 Version Page 11 of 72 PARSYS User Manual
33. c pressure 700 mb to 1060 mb Storage and transport conditions o Temperature 10 C to 50 C o Relative humidity level 10 to 85 o Atmospheric pressure 500 mb to 1060 mb 8 4Functional features Front panel m start up button configuration button under housing cover blue green LED indicating o steady green machine power on o steady blue Bluetooth transmission to PC or base 1 LCD 2 x 16 character line screen without backlighting Curved lower section 3 chromium plated brass convex round electrodes Upper section Hatch opening outwards and used to support the unit Upper section under hatch m 10 x 4 mm female cylindrical connectors with attachment collar between the two bodies 1 signal transfer control button to electrocardiograph analogue output or configuration Rear panel back m Instruction label 2 charging contacts Edges 1 folding articulated arm on either side supporting electrodes V1 V2 and V5 V6 2 lead model o Under the left arm 1 output of the wire VF electrode iliac with automatic winding system o Under the right arm 1 connecting socket for VR and VL cable 3 lead model o Under the right arm 1 connecting socket for VR VL and VF limb clips cable 10 15 2015 Version Page 62 of 72 PARSYS User Manual Telecardia 8 5 Functional flow chart TELECARDIA menu and voice message flow chart NB OUT button Button 1 diagram ON button Butt
34. ce TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 F D 20 06 59 1 Serial Number T07050343 Cardiniys MacAddress 20 06 59 1 Mac Address 40 16 7E 3C 24 B8 Pre identification Zone 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast sl Click on Remote Mac Address Then click on Write to save the new MAC address 10 15 2015 Version Page 44 of 72 User Manual Telecardia 707050343 40 16 7E 3C 24 B8 Cydic Storage quir 20 06 40 13 BlueTooth device s seen L vocal dense 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found 20 06 58 MS SPP dient 00 19 86 00 03 9C is now connect i y Modem Initialisation 20 06 58 1 Adding Device TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 SES IT O 20 06 59 1 Serial Number 107050343 cca 20 06 59 1 Mac Address 40 16 7E 3C 24 B8 Pre identification Zone 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast In the field Max Number of ECG replace the number by 1 if you only want to do an ECG at a time This is preferable to avoid any mistake in ECG Patient assignments 707050343 40 16 7E 3C 24 B8
35. ces 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 TEEN Separation distance according to the transmitter frequency m dou Li el output org 150kHz to 80MHz from 150kHz to 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 by 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 66 of 72 User Manual Telecardia 10 Maintenance 10 1 Cleaning
36. d 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 COM3 Go to the Local Services tab Click on Bluetooth Serial Port Then click on Properties Bluetooth Properties Notifications COM Port a oo Check Start up automatically and uncheck Secure connection Click on Apply then on OK 10 15 2015 Version Page 23 of 72 User Manual Telecardia 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 Required Dial up Networking Required Network Access Required Bluetooth Serial Port Required COM4 Add COM port Delete COM port em oom Go to the Client Applications tab Click on Bluetooth Serial Port Then click on Properties Bluetooth Properties COM Pott Uncheck Secure connection Clic
37. days 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 72 of 72
38. gths from fixed RF transmitters as determined by an electromagnetic survey on site should be less than the compliance level in each frequency range D Interferences may occur in the vicinity of equipment marked with the following symbol Ce 2 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 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 65 of 72 User Manual Telecardia PARSYS Recommended separation distan
39. hbourhood 20 06 40 13 BlueTooth device s seen Page 31 of 72 User Manual Telecardia TOFI 343 00 07 80 82 40 46 20 06 19 BlueTooth neighbourhood Inquiry 20 06 26 10 BlueTooth device s seen 20 06 32 BlueTooth neighbourhood i 20 06 40 13 BlueTooth device s seen If the search is unsuccessful you can click on Refresh which will start a new search 20 06 19 BlueTooth neighbourhood Inquiry 20 06 26 10 BlueTooth device s seen 20 06 32 BlueTooth neighbourhood i 20 06 40 13 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 32 of 72 User Manual Telecardia Battery 77 Hard Version 02 01 ee Message Version 02 03 FR i 707050343 40 16 7E 3C 24 B8 neighbourhood In 20 06 26 device s seen Cydic Storage Hetero Filtering 20 06 32 Too j Inquiry 20 06 40 13 BlueTooth device s seen vocal a Electrodes Test 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found 20 06 58 MS SPP dient 00 19 86 00 03 9C is now connect y Modem Initialisation GPRS UDP 20 06 58 1 Adding Device TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 IR 20 06 59 1 Serial Number T07050343 20 06 59 1 Mac Address 40 16 7E 3C 24
40. ight arm yellow on the left arm and green on the left leg that the electrodes and the skin have been humidified using the spray The patient and the user must be as relaxed as possible in order to avoid any tense movements when capturing the ECG 12 3 The Telecardia ECG is not charging Check that the protocol described in section 2 4 has been followed in particular that the Telecardia is in the correct position on its charging base that the red LED on the charging base is on during charging that the charging 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 70 of 72 User Manual Telecardia 12 4 The Telecardia ECG remains blocked If when using the device it blocks for more than 1 min Use the reset cable or take a metal object paper clip and place it on the charging contacts for 1s Place the equipment back on the charger and wait for the Charger indicator to come on Establish radio connection with the PC in configuration mode in order to update the device s internal real time clock Open the cover as shown on the photo press and hold the OUT button and press on the GREEN ON OFF button at the same time gf Lu OUT button E When the machine displays PARSYS Sant release both buttons The machine then indicates the time and date before displaying en cours
41. ing 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 72 PARSYS User Manual Telecardia 8 Technical features 8 1 General features Portable event driven 12 lead temporary electrocardiograph Radio data transmission Bluetooth Lithium polymer rechargeable battery power supply 8 2 Mechanical features 7 Material two half body unit one hinged hatch made of flame retardant ABS Color RAL 9002 white with marking Surface condition 26 arbours m Electrode on unit o chest on lower section gt VN V1 V2 V3 V4 V5 V6 7 10u chromium plated brass m Electrodes with cable o VR VL and VF peripheral limb clips cable m Connectors o female cylinder connectors with collar under bushing cover for electrocardiograph connection analogue trace output Protection index IP20 a Folded overall dimensions 210 mm x 100 mm x 50 mm m Weight lt 550g 8 3 Electrical specifications m Device intended for temporary use Device not protected against defibrillation shocks Device with internal electricity supply rechargeable lithium polymer batteries Battery life 50 peri critical ECG captures and Bluetooth transmission in one battery charge m Battery Built in Lithium Polymer battery 3 7V 1300mAh m Battery life 3 years life cycle Automatic p
42. ing until this window appears Click on Install Bluetooth Device 10 15 2015 Version Page 14 of 72 User Manual Telecardia Welcome to the InstallShield Wizard for WIDCOMM Bluetooth Software 5 5 0 9200 The InstallShield 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 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 fae gt Accept the agreement then click on Next gt 10 15 2015 Version Page 15 of 72 User Manual Telecardia 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 Cy Install WIDCOMM Bluetooth Software 5 5 0 9200 to C Program Files WIDCOMM Bluetooth Software InstallShield Cancel Click on Next gt i WIDCOMM
43. ion Page 21 of 72 User Manual Telecardia 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 virtual serial port connection with a remote application that supports the COM port number assigned fren cave 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 22 of 72 User Manual Telecardia Bluetooth Configuration General Accessibility Local 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 Secure Connection COM Port Printer Manu Required Bluetooth Imaging Auto Required Audio Gateway Auto Require
44. k on Apply then on OK 10 15 2015 Version Page 24 of 72 PARSYS User Manual Telecardia 4 2 Windows 7 Operating System 4 2 1 Requirements 4 1 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 1 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 In this case your computer must be connected to the Internet to install the Bluetooth USB adapter driver updating 4 1 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 Telecardia and the computer you have no other manipulation to perform Another provider stack We recommend you to communicate the name of the stack provider to the PARSYS Telemedicine After Sales Service before any installation confirmation procedure by the PARSYS Telemedicine After Sales Service In the latter case we recommend not to try the installation before obtaining 10 15 2015 Version Page 25
45. lick on Next gt GG 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 Cy Install WIDCOMM Bluetooth Software 5 5 0 9200 to C Program Files WIDCOMM Bluetaath Software InstallShield Cancel Click on Next gt 10 15 2015 Version Page 27 of 72 User Manual Telecardia 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 Click on Install CG 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 28 of 72 D S User Manual Telecardia TELEMEDECINE GG 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 Cancel Click on Finish Open the
46. of 72 User Manual Telecardia 4 2 2 Pairing of Telecardia 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 BlueTooth 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 InstallShield 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 Cancel 10 15 2015 Version Page 26 of 72 User Manual Telecardia Click on Next gt GG 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 O1 do not accept the terms in the license agreement InstallShield Ex wr gt Accept the agreement then c
47. on 2 diagram The text marked in red represents the voice prompts or information played Y On button AND OUT button active No LCD dialogue Defective technical self Setting 1 2 clear 1s beeps Technical problem please contact number on base 250 ms beep tests TELECARDIA PARSYS Sante hello TELECARDIA TECHNICAL PROB s PARSYS Tel e SYS Telemed Battery low Charge immediately 1 x 250ms beep Setting 1 TELECARDIA N 1 x 250ms bee OUT button enabled 4 d TELECARDIA memory ON button pressed for gt 3s Check that wired electrode TELECARDIA is positioned correctly on playback ECG transmission in LU 0 9 Start last ECG playback og 1 x 250ms beep every second for 15s ECG transmission Position fingers as in photo ion NI Transmission O eh Do not move during the 15 beeps MM complete Put machine on base Transmission 1 Time without event gt 4 min z lt lt lt Press machine against chest as in photo d Transmission 0 TELECARDIA Connection Start of capture 1 x 250ms beep every second for 15s Input completed 10 15 2015 Version Page 63 of 72 PARSYS User Manual Telecardia 9 Electromagnetic emissions Table 1 Directives and MANUFACTURER S statement ELECTROMAGNETIC EMISSIONS For all DEVICES and EM SYSTEMS Directives and manufacturer s statement electrom
48. ower off after transmission Internal protection using 500mA resettable fuse Type B class 2A machine diagnostic function Measurement with internal electrodes 9 simultaneous leads VR VL VF V1 V2 V3 V4 V5 V6 with reference to VN Reproduction of 12 leads D1 D2 D3 VR VL VF V1 V2 V3 V4 V5 V6 Input impedance 10 MQ Bandwidth 0 16Hz to 70Hz at 3db Adjustable to 30Hz by configuration Measurement linearity 0 01 Measurement sensitivity 2264 pt mV Sampling frequency 271 ps Backup of 6 peri critical 15 second ECGs rotating or fixed list backup management with saving maintained even without stack Saving of identification and configuration data in encrypted form Real time clock for ECG dating autonomy of 1 year from full charging level under normal storage conditions N Displayed and or voice task procedure or action messages 10 15 2015 Version Page 61 of 72 PARSYS User Manual Telecardia m 2 line 16 character screen task procedure message display Operating mode setting computer configuration o maximum number of ECGs o voice prompt o rotating stack locking o connection type Bluetooth type interface for computer link and transmission base link o Bluetooth version 2 0 EDR o Class 1 100 mW Average transmission speed 115 2 Kb s depends on medium used Operating conditions o Temperature 10 C to 35 C o Relative humidity level 30 to 75 o Atmospheri
49. t 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 Itis 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 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 Telecardia and the computer you have no other manipulation to perform Another provider stack We recommend you to communicate the name of the stack provider to the PARSYS Telemedicine After Sales Service before any installation confirmation procedure by the PARSYS Telemedicine After Sales Service In the latter case we recommend not to try the installation before obtaining 10 15 2015 Version Page 37 of 72 4 3 2 Pairing of Telecardia 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 BlueTooth Device Install Parsys Software Install PDFCreator Software Quit installation PARSYS
50. vice s seen V Cydic Storage V Hetero Filtering 20 06 32 BlueTooth neighbourhood Inquiry 20 06 40 13 BlueTooth device s seen LI Vocal dee _ Electrodes Test 20 06 48 Discovery of device s profile s _ Pre Identification 20 06 57 T07050343 1 profile s found Mode Connection 20 06 58 MS SPP client 00 19 86 00 03 9C is now connect Direct y Modem Initialisation GPRS UDP 20 06 58 1 Adding Device TeleCardia 20 06 58 1 Current time is 25 06 2015 at 20 06 58 emm 20 06 59 1 Serial Number T07050343 Cardialys MacAddress 20 06 59 1 Mac Address 40 16 7E 3C 24 B8 Pre identification Zone w 20 06 59 1 Read request of configuration v 3 20 06 59 1 Read of configuration completed LCD Contrast g Click on Disconnect 10 15 2015 Version Page 35 of 72 User Manual Telecardia T07050343 00 07 80 82 40 46 20 06 19 BlueTooth neighbourhood Inquiry 20 06 26 10 BlueTooth device s seen 20 06 32 BlueTooth nei i 20 06 40 13 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 72 PARSYS User Manual Telecardia 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 tha
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