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BodyCAP e-Celsius User Manual

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P070GUI002 – User manual e-Celsius Medical system EN.6
®
e-Celsius
Medical System
User Manual
MEASUREMENT SYSTEM CONTINUOUS RELIABLE AND
PRECISE TEMPERATURE, AND RECORDING
GASTROINTESTINAL BY TELEMETRY
Before use, please read
entirely theses instructions
Monitor e-Viewer®
BodyCAP
3, rue du Docteur Laënnec
14200 Hérouville Saint Clair
+33 (0)2.61.53.08.14
FRANCE
http://www.bodycap-medical.com
Email :
Support@bodycap-medical.com

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  • Page 1 P070GUI002 – User manual e-Celsius Medical system EN.6 ® e-Celsius Medical System User Manual MEASUREMENT SYSTEM CONTINUOUS RELIABLE AND PRECISE TEMPERATURE, AND RECORDING GASTROINTESTINAL BY TELEMETRY Before use, please read entirely theses instructions Monitor e-Viewer® BodyCAP 3, rue du Docteur Laënnec 14200 Hérouville Saint Clair...
  • Page 2 Medical monitor which records data and can restore them to a PC / MAC via the e-Celsius® Manager interface supplied with the e-Celsius device medical system. The capsule should be ingested with a glass of water.
  • Page 3 P070GUI002 – User manual e-Celsius Medical system EN.6 Table of Contents Precautions for use Use claims and contraindications Use claims ....................... 7 Contraindications and Warnings ................9 Risks and complications ..................11 Functions of e-Celsius® System ................12 First use Installation of e-Celsius®...
  • Page 4 7.1.2 Visualization of markers from the monitor e-Viewer® ............45 7.1.3 Visualization of markers ....................46 7.1.4 Hide markers ....................... 46 7.1.5 Export temperature data unloaded on e-Celsius® Manager ..........47 Secondary functions ....................47 7.2.1 Backup mode ......................47 7.2.2 Updating and changing the language of e-Viewer Medical monitor ........
  • Page 5 P070GUI002 – User manual e-Celsius Medical system EN.6 1 Precautions for use The following safety instructions ensure proper operation and will optimize the use of the e- Celsius ® Medical system. Follow them carefully. For questions which have not been answered in the manual, request assistance from your distributor or manufacturer (contact information at the end of this leaflet).
  • Page 6 35°C. The activator should be stored at temperatures between 0 and 40 °C. It is also recommended to avoid sprayed water and protect it from exposure to sunlight. During the period preceding the use of the Pill e-Celsius ® Medical, it must be kept in an...
  • Page 7 - Consult the dealer or an experienced radio/TV technician for help. This device e-Celsius Medical System 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 8 P070GUI002 – User manual e-Celsius Medical system EN.6 the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of an ingestible thermometer sensor (e-Celsius® Medical pill). The e-Celsius® Medical System consists of the following components:...
  • Page 9 Esophageal probe; Rectal probe. 2.2 Contraindications and Warnings Contraindications: The e-Celsius® Medical System is designed for the measurement of core body temperature in humans, it is contraindicated in a number of situations: For people whose body weight is less than eighty (80) pounds.
  • Page 10 - The e-Celsius® Medical pill (Fig. 6) is intended to be ingested, with a glass of water to measure the gastrointestinal temperature. It is delivered in deep standby. It must be awakened by the activator and associated with a monitor to operate.
  • Page 11 • Injury or injury to the gastrointestinal system requiring surgery • A false route at the time of ingestion of the e-Celsius® Medical pill, which can induce partial or total obstruction of the airways. • False route with blockage in the respiratory tract requiring extraction •...
  • Page 12 ® Medical pill to an e-Viewer ® monitor The display of the temperature graph on the computer screen via the e-Celsius® Manager software The device is based on the principles listed in Table 2. Table 2: Operating principle Operating principle The activation of the Pill e-Celsius ®...
  • Page 13 P070GUI002 – User manual e-Celsius Medical system EN.6 Setting the time and date of the monitor e-Viewer ® Medical with the e-Celsius ® manager software Setting patient's information, displayed on the e-Viewer ® Medical monitor screen, with the e-Celsius ®...
  • Page 14 P070GUI002 – User manual e-Celsius Medical system EN.6 The language of the interface can be changed after opening the application e-Celsius® Manager. Select "File> Language" menu. 3.2 Implementation of the device 3.2.1 Power up the monitor e-Viewer® Medical To turn on the monitor e-Viewer ®...
  • Page 15 It is possible to select one of the 7 channels (1 to 7) available on the monitor. • Date and hour The date and time of the computer on which the e-Celsius® Manager application is installed will be sent to the monitor when using the "Apply" button. This time will date the upcoming recordings.
  • Page 16 P070GUI002 – User manual e-Celsius Medical system EN.6 3.2.3.2 The tab Subject Figure 4: Tab for Subjects’ data configuration The tab "Subject" (Fig. 4) allows to configure a monitor for a patient. Thus, the four fields can be filled according to the choice of each. The contents of field 1 will be displayed on each bottom of the monitor (Fig.
  • Page 17 Medical Figure 7: Warning bracelet The e-Celsius® Medical pill (Fig. 6) is intended to be ingested with a glass of water to measure gastrointestinal temperature. It is delivered in deep sleep. It must be woken up by the activator and associated with a monitor to work. Attach the identification bracelet to the wrist of the patient before swallowing the pill (Fig.
  • Page 18 P070GUI002 – User manual e-Celsius Medical system EN.6 The battery The pill e-Celsius® Medical includes 4 batteries (Zinc–Silver Oxide). In fact, the pill should not be disposed with the household waste. Cleaning The pill is supplied sterile (sterilization with ethylene oxide) and must be activated through the blister to maintain its sterility.
  • Page 19 P070GUI002 – User manual e-Celsius Medical system EN.6 The label contains a symbol from the IEC 60601-1: "Follow the using instructions" "Applied part type BF" Also, the label precise the following mentions: "This is not a drug" "Protection Index" "Medical device CE marked by the notified body LNE-GMED"...
  • Page 20 P070GUI002 – User manual e-Celsius Medical system EN.6 Transmission distance with the monitor: around 1m (depending from environment). Ingress Protection (IP): X8 (Material supporting prolonged immersion) Power: autonomous system including zinc-silver oxide piles. Battery life: 20 days. Contact time with the patient: 2 ±...
  • Page 21 P070GUI002 – User manual e-Celsius Medical system EN.6 5 The Activator Figure 8: Activator The Activator (Fig. 8) is intended to activate the pill e-Celsius® Medical before a measurement cycle. 5.1 Important information and safety instructions The battery The system does not include any battery. For each use, the power supply of the Activator is performed by mains supply or a PC / MAC switched on.
  • Page 22 P070GUI002 – User manual e-Celsius Medical system EN.6 The label The label contains the symbols of the NF EN 980: SN : XXX "Serial Number” "Catalogue reference" "Manufacturer + Production date" AAAA "Temperature storage limit" "Keep dry" "Keep away from light and sun"...
  • Page 23 P070GUI002 – User manual e-Celsius Medical system EN.6 Dimensions: Length: 690 mm. Width: 590 mm. Height: 310 mm. Weight: ≈ 62 g. Main power supply unit (100  240 V) or PC via USB (5 V). Power supply:  115 mW only connected (out of operation) and 500mW during Power consumption: activation (for 2s).
  • Page 24 P070GUI002 – User manual e-Celsius Medical system EN.6 6 The monitor e-Viewer Medical Figure 10: Monitor e-Viewer Medical The monitor is intended to communicate in RF with the pill e-Celsius® Medical to recover and store temperature data. 6.1 Important information and safety instructions The battery The monitor e-Viewer Medical contains a Lithium-ion battery.
  • Page 25 P070GUI002 – User manual e-Celsius Medical system EN.6 each pill is limited to 2000 data, the communication between the pill and the associated monitor must be restored within a maximum period of 15 hours under penalty to definitively lose some data (the automatic synchronization pill / monitor can last several minutes depending on the number of data to be recovered).
  • Page 26 P070GUI002 – User manual e-Celsius Medical system EN.6 Description of the Monitor LEDs Micro-USB Screen TFT connector Figure 11: Description of the monitor e-Viewer Medical 6.3 Features Dimensions: Length: 120 mm. Width: 70 mm. Thickness: 15 mm. Weight: ≈ 120 g.
  • Page 27 P070GUI002 – User manual e-Celsius Medical system EN.6 Condition of carriage and storage: Temperature (0 to 35°C), humidity (30 to 80%) Way to disconnect from the mains supply: Unplug the power cable. Warning: Modification of the electro-medical device is forbidden 6.4 The buttons...
  • Page 28 It will be mandatory to return to the e-Celsius® Manager application to reset it. Connect to e-Celsius® Manager and check that the monitor is connected to the PC and turned on. Going to the "File> Update Time" menu will automatically update the monitor (Date / Time) according to the PC settings.
  • Page 29 The battery level of the monitor (eg the top right of the screen)  The operating channel of the monitor (eg C2)  A field corresponding to a patient identification (eg Patient BODYCAP)  The number of pills associated (eg Caps 0) ...
  • Page 30 P070GUI002 – User manual e-Celsius Medical system EN.6 Figure 13: Screen of the monitor e-Viewer Medical with the symbol related to full memory status  An orange triangle in the top banner of the screen indicates that a physiological alarm has been triggered and should be investigated (Fig.
  • Page 31 P070GUI002 – User manual e-Celsius Medical system EN.6 Tree view of the main menu of the monitor (Fig. 15) Figure 15: Main menu of the monitor e-Viewer Medical To validate a menu and move to submenu, press the button OK (§ 6.4).
  • Page 32 The About menu allows you to view the software version of the e-Viewer Medical Monitor as well as identify the monitor from its unique address. 6.10 Main functions 6.10.1 Set the monitor To set the monitor, please connect it to the computer via USB to use the e-Celsius® Manager software.
  • Page 33 ® medical pill activation, you must fill the Subject information in the configuration interface of e-Celsius® Manager. Please also check the monitor's operating channel and the date and time. No modification of these parameters will be possible after the activation of a pill.
  • Page 34 If the LED of the activator stops flashing and the message "Error! Would you like to restart an activation" appears on the monitor screen, please check the positioning of the e-Celsius® Medical Pill in the hole of the Activator and / or slightly move the e-Celsius® Medical pill in the hole, press the button OK on the monitor e-Viewer Medical to restart the association process and re-press then the button on the Activator.
  • Page 35 Minimum and maximum temperature thresholds may be used to trigger a visual alarm. To set up the thresholds, you can use e-Celsius® Manager software or the menus on the monitor. To do this, go to the menu "Alarm" and select "Threshold setting." The window (fig.21) is...
  • Page 36 P070GUI002 – User manual e-Celsius Medical system EN.6 The button OK allows to switch from one number to another, from the left to the right, the button Back allows to return to the previous digit and the arrows allow to modify the value of the digit in progress (red).
  • Page 37 P070GUI002 – User manual e-Celsius Medical system EN.6 The delay inherent in the determination of an alarm condition is a maximum of 30 seconds in the case of a real-time communication between the pill and the monitor. In addition, regardless of the screen you are on, an alert icon is permanently displayed in the top banner of the monitor screen even on a screen that does not display the triggering of the alarm.
  • Page 38 P070GUI002 – User manual e-Celsius Medical system EN.6 6.10.8 Detailed visualization of the data of one pill. To access to a detailed visualization, select the pill by positioning it in the right of the screen. Then press the OK button, a new screen appears with the following information: Figure 24: Detailed visualization screen of a pill The number of the selected pill (from 1 to 3).
  • Page 39 P070GUI002 – User manual e-Celsius Medical system EN.6 time , from several minutes to several hours depending on the number of data to recover). Warning: The monitor synchronize first the oldest data available in the memory of the pill. The most recent are thus recovered last.
  • Page 40 P070GUI002 – User manual e-Celsius Medical system EN.6 Figure 25: Illustration of the operating mode of the synchronization Example: Temperature monitoring with one pill (Sampling frequency 30s). Data synchronization is performed after 10 hours of missing communication. Data collected in real time are always stored T0 –...
  • Page 41 It is possible to observe an inaccuracy of a few minutes for the recorded time. A green marker "Backup mode" on the chart displayed on e-Celsius® Manager Software indicates the beginning of the Backup mode. All the data before this marker are synchronized data.
  • Page 42 Three cases may be displayed:  “Locked / Data to be saved": The data of a pill remains on the monitor, but the pill is no longer associated. Data can be downloaded on the e-Celsius ® Manager Software. As unloading did not take place, a new pill cannot be activated on this location.
  • Page 43 P070GUI002 – User manual e-Celsius Medical system EN.6 6.10.14 Overview of the alarm system Caregivers should regularly control the temperature data displayed on the e-Viewer Medical monitor screen. The monitor combines 7 categories of alarms with 6 related to the state of the electro-medical system and 1 on the patient's physiological status.
  • Page 44 P070GUI002 – User manual e-Celsius Medical system EN.6 Alarm Internal The monitor is faulty Immediate, the use Orange flashing Medium Error of the monitor is LED + Warning prohibited message on the monitor...
  • Page 45 An unloading progress window appears. At the end of the unloading, the temperature data appear graphically (Fig. 29) Figure 29: Picture of the curves obtained on the e-Celsius® Manager Software after data unloading. It is possible to move on the graph by keeping key Alt pressed and clicking the left mouse button while sliding it from the left to the right.
  • Page 46 Once an alarm is triggering on the monitor (technical or physiological), an alarm marker is stored in the monitor. These markers are then viewable on e-Celsius® Manager Software by vertical red dashed lines. The reason for the alarm is indicated at the bottom of the marker.
  • Page 47 To do this, it is necessary to start backup Mode with another monitor. This mode enables retrieval of data from all the e-Celsius® Medical pills functioning on the selected channel, in the communication range of the monitor and whose serial number is known.
  • Page 48 Note: To exit the recovery mode, connect the monitor to a PC with the cables provided by the manufacturer and go again to the tab Backup mode on the e-Celsius® Manager software. Click then on "Disable backup mode." Banners on the monitor switch then again in black, indicating that the replacement mode is stopped.
  • Page 49 As the capsule is radiopaque, an X-ray will allow remove any doubts. If the e-Celsius® medical pill is found to be blocked, it may be subject to a decision to extract by endoscopy, surgery or any other means, at...
  • Page 50 9 TECHNICAL DATA 9.1 ESSENTIAL PERFORMANCE For the e-Celsius® Medical System device, the essential performance lies in the continuous measurement of core body temperature in individual There is no need to perform tests to maintain the essential performance or safety because...
  • Page 51 Guidelines and manufacturer’s declaration (electromagnetic emissions) The e-Celsius® Medical System device is intended for use in the electromagnetic environment. tick described in the table below. The user and the installer must therefore ensure that the device medical is used in the environment described below.
  • Page 52 Guidance and manufacturer's declaration of conformity regarding electromagnetic immunity The e-Celsius® Medical System device is intended for use in the magnetic environment and electromagnetic described in the table below. The user and the installer should ensure the electromagnetic environment compliance.
  • Page 53 P070GUI002 – User manual e-Celsius Medical system EN.6 Electromagnetic immunity, radiofrequencies: The e-Celsius® Medical System device is intended for use in the magnetic environment and electromagnetic described in the table below. The user and the installer should ensure the electromagnetic environment compliance.
  • Page 54 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device e-Celsius Medical System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help...
  • Page 55 P070GUI002 – User manual e-Celsius Medical system EN.6 10 Failures guide Tableau 5: Failures guide Problem Probable cause Solution Connect it on the mains supply and wait few minutes before The battery of the monitor is interacting the monitor (on the...
  • Page 56 P070GUI002 – User manual e-Celsius Medical system EN.6 11 Cables and power supply Two cables are supplied with the system: two USB - micro-USB cables that allow you to connect the e-Viewer® Medical monitor to a computer to download the data or power the monitor and / or the activator by connecting them to a computer on or to the mains through the adapter.
  • Page 57 P070GUI002 – User manual e-Celsius Medical system EN.6 12 The Wristband The ‘no MRI’ wrist strap should be attached to the wrist before ingestion of a pill and removed after expulsion of the pill (Fig. 7). A wristband is provided for each pill delivered. These wristbands are in the box with the pills.
  • Page 58 P070GUI002 – User manual e-Celsius Medical system EN.6 BodyCAP 3, rue du Docteur Laënnec 14200 Hérouville Saint Clair FRANCE support@bodycap-medical.com +33 (0)2.61.53.08.14 Support@bodycap-medical.com http://www.bodycap-medical.com...