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BodyCAP eCelsius Performance User Manual

Telemetric system for continuous gastrointestinal temperature data collection
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T E LEM E T R IC SYS T EM FO R C O NT I NUO US
GA S TRO I NT ES T I N A L TE M PE RATURE
DATA CO L LE CT I O N
SYSTE M D ED ICAT ED TO NON- MEDI C AL USES
USER GUIDE
P060GUI001 – User manual eCelsius Performance system.10 - EN

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Summary of Contents for BodyCAP eCelsius Performance

  • Page 1 GA S TRO I NT ES T I N A L TE M PE RATURE DATA CO L LE CT I O N SYSTE M D ED ICAT ED TO NON- MEDI C AL USES USER GUIDE P060GUI001 – User manual eCelsius Performance system.10 - EN...
  • Page 2 P060GUI001 – User manual eCelsius Performance system.10 - EN...
  • Page 3 P060GUI001 – User manual eCelsius Performance system.10 - EN I N DE X 1. PRECAUTIONS FOR USE 2. USE CLAIMS AND CONTRAINDICATIONS Use claims Contraindications and warnings 3. FIRST USE Installation of ePerformance Manager Software Implementation of the device Power up of the eViewer Performance monitor...
  • Page 4 P060GUI001 – User manual eCelsius Performance system.10 - EN Detailed temperature data visualization Synchronization of the data in the memory of the electronic capsule Visualization of the end-of-life of the electronic capsule Min / max reset Measurement period End of the data collection...
  • Page 5 P060GUI001 – User manual eCelsius Performance system.10 - EN eViewer Performance technical data Characteristics Environmentals conditions Power supply technical data Characteristics 10. FAILURES GUIDE 11. SYMBOLS...
  • Page 6 P060GUI001 – User manual eCelsius Performance system.10 - EN Pi c t u re s i nd ex Picture 1: USB stick BodyCAP Picture 2: Start screen of ePerformance Manager Picture 3: Tabs to configurate the monitor Picture 4: Tab for subject’s data configuration...
  • Page 7 Performance system. This solution is manufactured by BodyCAP. This user guide aims to present the caracteristics and the way of working of the solution and to support you in the installation and the use of the device. A proper use of the solution does not imply specific training or skills;...
  • Page 8 (contact information at the end of this user guide). The eCelsius Performance electronic capsule is not claimed MRI compatible: It is imperative that the subject ingesting an electronic capsule does not undergo any MRI. The subject should wear the signaletic bracelet supplied with the system and indicating that he is wearing a device non-compatible with high magnetic fields exposure.
  • Page 9 PRECAUTIONS FOR USE OF THE eCELSIUS PERFORMANCE ELECTRONIC CAPSULE: Do not use the electronic capsule if the packaging is damaged. The complete eCelsius Performance system should be kept out of the children. Particular attention must be paid with the electronic capsules, to avoid any risk of suffocation.
  • Page 10 - Consult the dealer or an experienced radio/TV technician for help. This eCelsius Performance complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.
  • Page 11 2. USE CLAIMS AND CONTRAINDICATIONS USE CLAIMS The eCelsius Performance system is an electronic device for non-medical uses only. The device is NOT intented for use in diagnosis, treatment, prevention or management of any diseases. The device is designed for continuous human gastrointestinal temperature measurement.
  • Page 12 Potential complications: - Swallowing the ‘‘wrong way’’ the eCelsius Performance electronic capsule, may induce partial or total airway obstruction, - Blockage of the electronic capsule within the digestive tract, which may require recovery by endoscopy or surgery.
  • Page 13 To use the eViewer Performance monitor with the PC / MAC ePerformance Manager software, you have to install the PC / MAC ePerformance Manager software and the BodyCAP drivers (provided on the USB stick). At the end of the installation, the monitor and the PC / Mac software will automatically interface.
  • Page 14 P060GUI001 – User manual eCelsius Performance system.10 - EN Picture 2: Start screen of ePerformance Manager At the opening of the second window (Picture 3), several tabs allow to configure the monitor before using. THE TAB MONITOR Picture 3: Tabs...
  • Page 15 P060GUI001 – User manual eCelsius Performance system.10 - EN In order to reduce interferences, the selected channel has to be different from those of the other monitors working in the same environment. You can select one of the 7 channels (1 to 7) available on the monitor. By default, the channel use is the channel 4.
  • Page 16 They allow to inform the researches that the subject swallowed a electronic capsule and thus that is forbidden to perform an MRI exam. 5. THE ACTIVATOR The activator is intended to activate the electronic capsule eCelsius Performance before a recording session. Hole to place the...
  • Page 17 In order to optimize the activation process, please rotate the electronic capsule into the hole during the activation process. 6. eViewer Performance MONITOR The monitor is intended to communicate in RF with the eCelsius Performance electronic capsule to retrieve and store temperature data. LEDs...
  • Page 18 P060GUI001 – User manual eCelsius Performance system.10 - EN THE BUTTONS The monitor has got 6 buttons; the features are described below. 5 are placed around the screen and 1 on the right side: - Confirm (n°1 - Picture 9) : The button Confirm is used to confirm the information and to go to the menu.
  • Page 19 P060GUI001 – User manual eCelsius Performance system.10 - EN In order to leverage the risk to lose the connection between the electronic capsules and the monitor, the device automatically goes into a power-saving configuration (extinction of the screen and of the RF communication with the electronic capsules) before the total discharge of the battery.
  • Page 20 P060GUI001 – User manual eCelsius Performance system.10 - EN MONITOR INTERFACE MENU Picture 10: Screen of the eViewer Performance monitor Whatever the level of the menu in which the user is, the monitor screen indicates some general information including: - Date (e.g. 18/04/2018 => DD/MM/YYYY).
  • Page 21 P060GUI001 – User manual eCelsius Performance system.10 - EN The Subject menu The Subject menu displays user data. The four fields are configurable from the ePerformance Manager software. Then Field 1 is visible on all monitor screens, in the lower band. A limitation of the size of each field is indicated in the ePerformance Manager software.
  • Page 22 P060GUI001 – User manual eCelsius Performance system.10 - EN Min/max reset: Allows to reinitialize the data display for min and max value on the detailed data visualization screen. Measurement period: Allows to change the measurement period of the electronic capsule.
  • Page 23 Picture 16: eViewer Performance monitor menu to set the operating channel This command is not possible when eCelsius Performance electronic capsules are associated with the monitor. The following message appears on the screen: Picture 17: Setting channel error message Think about recording the working channel of each monitor; in case of breakage or failure, this information will be needed to launch the monitor replacement procedure (cf.
  • Page 24 P060GUI001 – User manual eCelsius Performance system.10 - EN - The message ‘‘Place the capsule, red part down’’ appears. The electronic capsule to activate has to be placed in the hole of the activator. Then press the button ‘‘Confirm’’ on the monitor.
  • Page 25 P060GUI001 – User manual eCelsius Performance system.10 - EN Picture 19: Home screen menu of data view Temperature data (real time temperature data, min and max) of 1 to 3 electronic capsules may be displayed on the screen. The symbol...
  • Page 26 P060GUI001 – User manual eCelsius Performance system.10 - EN The electronic capsule has an internal memory that automatically records the last 2000 measurements collected. Once 2000 data have been collected and stored in the electronic capsule memory, the 1 deleted and replaced by the 2001 , …...
  • Page 27 P060GUI001 – User manual eCelsius Performance system.10 - EN...
  • Page 28 P060GUI001 – User manual eCelsius Performance system.10 - EN Complementary information for Backup mode: If data are synchronized without initial data (which is the case in Backup mode), the time and date associated to the data will be estimated. It is possible that of an inaccuracy of a few minutes occurs for the estimated time.
  • Page 29 ( eViewer Performance Monitor Main functions > Detailed View of Capsule Data). The real-time capture of new data informs you that the eCelsius Performance electronic capsule is always present and active. This verification procedure can be repeated later.
  • Page 30 P060GUI001 – User manual eCelsius Performance system.10 - EN The life duration of the electronic capsule is limited to 20 days, beyond this period, the method described above is no longer usable. The electronic capsule being radiopaque, an X-ray exam will allow the removal of doubt.
  • Page 31 P060GUI001 – User manual eCelsius Performance system.10 - EN USE OF THE MONITOR SCREEN In order to save battery, the monitor screen will switch off automatically after 3 minutes of inactivity when the monitor is in battery operation. This action is cancelled when the monitor is in power supply mode.
  • Page 32 MAIN FUNCTIONS To use the eViewer Performance monitor with ePerformance Manager software, you must install the application and the drivers (provided on the USB key BodyCAP). When the installation is completed, the monitor and the application may automatically interface. UNLOAD AND CONSULT THE TEMPERATURE DATA ON THE ePerformance Manager SOFTWARE On the main screen of the ePerformance Manager software, select the menu ‘‘Unloading’’...
  • Page 33 P060GUI001 – User manual eCelsius Performance system.10 - EN Picture 27: Screen of marker management AUTOMATIC MARKERS ON ePerformance Manager SOFTWARE Once automatic alarm is triggered on the monitor, an alarm marker is stored in the monitor. Then these markers are visible on ePerformance Manager software by vertical red dashed lines. The reason for the trigger is indicated at the bottom of the marker.
  • Page 34 P060GUI001 – User manual eCelsius Performance system.10 - EN EXPORT TEMPERATURE’S DATA UNLOADED ON ePerformance Manager SOFTWARE To export temperature data, one curve or more may be selected from the icons at the top right of the screen, shown in Picture 26.
  • Page 35 It is necessary to start the backup operation with an operational monitor. This mode will allow to retrieve data from all the eCelsius Performance electronic capsules communicating on the selected channel, in the communication range of the monitor and whose ID number is known.
  • Page 36 P060GUI001 – User manual eCelsius Performance system.10 - EN Warning: all the electronic capsules must have been first activated with the same original monitor. Select ‘‘Apply’’. You will see the banners of the monitor switch from black to white, indicating the use of the Backup mode.
  • Page 37 P060GUI001 – User manual eCelsius Performance system.10 - EN 8. CABLES AND POWER SUPPLY Two cables are supplied with the system: two USB - micro-USB cables which allow to connect the monitor to a computer to download data or power the monitor and/ or the activator by connecting them to a computer on or sector through the adapter (in option).
  • Page 38 P060GUI001 – User manual eCelsius Performance system.10 - EN ePerformance Manager REQUIRED CONFIGURATION Minimal configuration Requirement: - Processor 1GHz. - 500Mo de RAM. - 200Mo disk space required for the installation. - Windows 7 or operating systems Microsoft compatibles (32 or 64 bits).
  • Page 39 P060GUI001 – User manual eCelsius Performance system.10 - EN Storage and/or transport eCelsius Performance electronic capsule in the blister: - Humidity between 20 and 80% relative humidity - Atmospheric pressure between 700hPa and 1060hPa - Ambient temperature conditions between 5 and 35°C...
  • Page 40 P060GUI001 – User manual eCelsius Performance system.10 - EN Connector: Female micro-USB Power supply: Battery Lithium-ion rechargeable with a main supply adapter (100 ~ 240 V) and a cable micro-USB – USB provided with the system. Time to charge: ≈ 3 h.
  • Page 41 P060GUI001 – User manual eCelsius Performance system.10 - EN 10. FAILURES GUIDE Issue Probable cause Solution Check that the monitor is not in Monitor standby. standby or deep standby. The battery of the monitor is Connect the monitor to a power discharged.
  • Page 42 P060GUI001 – User manual eCelsius Performance system.10 - EN 11. SYMBOLS ‘‘Do not reuse’’ ‘‘Batch code’’ ‘‘Catalogue number’’ ‘‘Manufacturer address’’. This symbol is associated with the manufacturing year for the monitor and the activator (format YYYY), and the month and year of production for electronic capsules (format YYYY-MM).
  • Page 43 P060GUI001 – User manual eCelsius Performance system.10 - EN...
  • Page 44 For any questions concerning the system operation that is not included into the user guide, please contact BodyCAP Team : BODYCAP 3, rue du Docteur Laennec 14200 Hérouville St Clair FRANCE +33. (0)2 61 53 08 14 support@bodycap.io www.bodycap-medical.com...