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P063GUI001 - User guide eCelsius Performance Connect.1 - EN

TELEMETRIC SYSTEM FOR

CONTINUOUS CORE TEMPERATURE MONITORING

USER GUIDE

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Summary of Contents for e Celsius Performance Connect

Page 1: ...1 P063GUI001 User guide eCelsius Performance Connect 1 EN TELEMETRIC SYSTEM FOR CONTINUOUS CORE TEMPERATURE MONITORING USER GUIDE ...

Page 2: ...2 P063GUI001 User guide eCelsius Performance Connect 1 EN ...

Page 3: ...ce 11 The buttons 11 The LED 11 The battery 12 The charge cable 12 The RF communication 12 ePerf Connect screen information 13 e Perf Mobile application 14 4 OPERATING PRINCIPLES 14 First use 14 ePerf Connect device implementation 14 ePerf Mobile installation 14 Main view of the application 15 ePerf Connect ePerf Mobile peering 15 Main functions 16 ePerf Connect configuration on ePerf Mobile 16 Ca...

Page 4: ... Capsule desassociation 20 Secondary functions 21 ID capsules vizualization 21 Markers 21 Capsule pause mode 22 Old capsule vizualization archives 22 Data exportation 23 ePerf Connect battery management optimization 23 End of monitoring application 24 ePerf Connect device turn off 24 ePerf Connect update 25 eCelsius Performance Connect System Alert system vizualization 25 6 FAILURES GUIDE 29 ...

Page 5: ...to be woken up thanks to the Activator and associated with the ePerf Connect device which records the data and can return them to an Android Smartphone or Tablet through the ePerf Mobile Application Declaration of conformity BodyCAP declares that the eCelsius Performance Connect solution is compliant with current directives and regulations 2011 65 UE relative à la limitation de l utilisation de ce...

Page 6: ...ss the ePerf Connect screen Do not use the capsule if the packaging is damaged Do not expose the Activator to rain or humidity keep it away from liquids or sprayed water In order to reduce the risk of fire electric shock and interference only use the micro USB cable and the adapter supplied with the system Do not use during a gaz leak It is highly recommended to pay attention to the localisation o...

Page 7: ...nent damage for the element concerned The other elements of the system ePerf Connect activator may be cleaned using a hydroalcoholic wet wipe Règlement européen REACH 1907 2006 EC Under the requirement of the Article 33 1 of the REACH European regulation we inform users that the SVHC Octyl Tin Stabiliser substance is present in capsule compounds in a concentration upper than 0 1 weigh weigh SVHC c...

Page 8: ...Connect device must not be used for diagnosis or therapeutic uses in patients CONTRAINDICATIONS AND WARNINGS Contraindications The eCelsius Performance Connect system is contraindicated in a number of situations Individuals under the age of 18 years For people weighting less than 40Kg For Pregnant women For people with pacemaker or electrico medical implant For people with or presenting risk of in...

Page 9: ...etween the eCelsius Performance capsule and the ePerf Connect device causing a stop of the subject s temperature monitoring The collection of temperature data affected by the ingestion of cold or hot drinks which could lead to an erroneous interpretation of the data Exposure to a strong electromagnetic field MRI which may lead to a risk of mobilization with possible trauma to the digestive tract o...

Page 10: ...s They allow to inform the caregivers that the subject swallowed a capsule and thus that it is forbiddden to perform an MRI exam Figure 1 eCelsiusPerformance capsule Figure 2 Signaletic bracelet eCelsius Performance capsule In case of successive ingestion the bracelet has to be removed after the expulsion of the last capsule THE ACTIVATOR The activator is intented to activate the eCelsius Performa...

Page 11: ...sule to retrieve the temperature data ePerf Connect device Bouton 1 Bouton 2 LED Figure 4 ePerf Connect device WARNING Modification of the device forbidden The device has 2 buttons with differents functionalities Button 1 Long press Turn on the device if it is switched off Add a marker if the device is switched on Short press Switch on or switch off the screen Confirm a message to come back to the...

Page 12: ... the system before turning it on pressing the button 1 long press If this state lasts several days the device will lost the date time information You will have to set again the date and time through the ePerf Mobile application that will take effect from the connexion to the application In operation it is strongly recommanded to wear the ePerf Connect device to the wrist if possible Lay down the d...

Page 13: ...y level An exclamation mark appears if the level is low and the corresponding alert is triggered An outlet symbol appears if the system is on charge BLE connexion activated the ePerf Connect device is connected to an Android device in real time The symbol disapears if the device is not connected anymore in real time to a BLE device Errors messages may appear before the time is displayed It is reco...

Page 14: ... not turn on connect the ePerf Connect device to a power source and try again few minutes later A LED confirms the pression on the button Before use of the ePerf Connect on battery mode please ensure that the charge level is sufficient A symbol on the screen of the ePerf Connect device indicates the level of battery BATTERY CHARGING If you intend to use the ePerf Connect device on battery mode ple...

Page 15: ...nsented at the bottom of the screen with logos MAIN VIEW OF THE APPLICATION Figure 5 Main screen of the ePerf Mobile Application ePerf Connect ePerf Mobile peering To communicate the ePerf Connect device and the ePerf Mobile application have to be paired To do so the application will guide you in the sucessive actions 1 Creation profile use A profile corresponds to a subject that intend to use an ...

Page 16: ...creen of the ePerf Connect device On ePerf Mobile a green reference ePerf Connect XX XX should appear that indicates the ePerf Connect device is available for a BLE association Once selected please validate the peering by entering in ePerf Mobile Application the code displayed on the screen of the ePerf Connect device The ePerf Connect device will appear in the list of available paired devices In ...

Page 17: ...his is an advanced parameter limiting the interferences between several ePerf Connect device operating in the same environment This parameter is not modifiable anymore once capsules are associated to the ePerf Connect device Comment addition The application allows to add a comment to a profile In the profile settings select comment and enter a note up to 64 characters Remark A new setting has to b...

Page 18: ...tton of the application to launch again the activation process and press again the button of the activator The eCelsius Performance capsule is now ready to be swallowed by the subject with a glass of water to measure gastrointestinal temperature Please follow the use claims and contraindications introduced on the page 8 The signaletic bracelet Fig 2 has to be worn just after capsule ingestion The ...

Page 19: ...the capsules associated The date and time for this data 04 33 PM 10 08 2021 The battery level of the ePerf Connect device 80 The number of capsule associated 1 red click on the capsules allows to display the status for each capsule extend fold up the status Display the graph with all the capsule associated to the ePerf Connect device C1 C2 C3 Display the graph only for C1 The capsules temperature ...

Page 20: ...l synchronized the data once it will come back close to the capsules concerned The numeric indication displayed on the ePerf Mobile Application should alert of any issue regarding the communication between the capsule and the ePerf Connect device When the use of the capsule is over capsules released end of the monitoring period the desassociation with the ePerf Connect device is performed through ...

Page 21: ...ate and time updated through the ePerf Mobile App Capsule activated 1 2 3 yes A capsule 1 2 3 is associated Capsule deactivated 1 2 3 yes A capsule 1 2 3 is deactivated Internal alert XX yes The ePerf Connect device triggered a technical alert that re quires an intervention of the support service team Slot memory 1 2 3 full yes Memory of the ePerf Connect device full Measurement period yes New mea...

Page 22: ... data loss if the capsule is swallowed and the Pause mode is not removed It is strongly recommanded to check on the ePerf Mobile application that you have access to the real time data before ingestion The Pause mode may also allow to save battery of the ePerf Connect device cf p23 CAPSULE PAUSE MODE It is possible that one or several capsules have been activated at the same time to cover consecuti...

Page 23: ...rted by capsules However it is possible to sort them in chronological order To do so please select all the dates of the capsules concerned then Sort by date and Extend the selection to the columns of data ePerf Connect BATTERY MANAGEMENT OPTIMIZATION The ePerf Connect device is optimized for an RF communication with 1 to 3 capsules simultaneously However if a capsule is removed or stay away from t...

Page 24: ...device The device will no longer appear in the list of available devices You will have to go through the pairing process again to be able to reset communication with the device Example of use The device disappears completely from the user s environment This one will no longer follow this device in the future rental return Reset the device Resetting the device will couple profile device separation ...

Page 25: ...f ePerf Connect device Notification and number of mission data dis played Symbol on the capsule status Full memory The ePerf Connect device does not enough memory to ensure data storage Immediate Flashing LED Notification info dis played in the ePerf Connect device parameters Internal error alert The ePerf connect device is faulty Immédiate the usability of the device is limited Flashing LED messa...

Page 26: ...asurement period Communication frequency ISM Band 433MHz 434MHz Measurement period available 15s 30s 1min 2 min 5min Plastic Biocompatible PVC The manufacturing date is indicated on the blister of the pill The shelf life of the eCelsius Performance capsule is validated for a use up to 24 months after this date Beyond that date device performances and autonomy are not guaranteed ENVIRONMENTAL CONDI...

Page 27: ...30 and 80 HR pression atmosphérique comprise entre 700hPa et 1060hPa température ambiante comprise entre 5 et 40 C Storage and or transportation Humidity between 30 and 80 HR Atmospheric pressure between 700hPa and 1060hPa Ambiant temperature between 0 and 45 C Avoid sprayed water Avoid unlight exposure Dimensions Lenght 52 mm Width 25 mm Height 15 mm Weight 33g Device bracelet Screen 128 x 32 pix...

Page 28: ...e and or transportation Humidity between 30 and 80 of relative humidity Atmospheric pressure between 700hPa and 1060hPa Ambiant temperature between 5 and 35 C Avoid sunlight exposure Avoid sprayed water Storage Transport Use Temp C Humidity Pressure HPa Temp C Humidity Pressure HPa eCP capsules P022 5 35 C 30 80 700 1060hPa 25 45 C 100 700 1060hPa ePerf Connect device P110 5 35 C 30 80 700 1060hPa...

Page 29: ...ation is difficult check that the pill is within range of the ePerf Connect or turn the pill into the activator hole ePerf Mobile shows the number of capsules associated Automatic synchronization does not work The ePerf Connect is on charge Unplug the cable from the ePerf Connect and wear the device to the wrist Please ensure that the capsule is close enough to the device and check the date time o...

Page 30: ...ol is associated to the year of the manufac turing date for the ePerf Connect device and Activator format AAAA and to the month and the year of the capsule manufacturing format AAAA MM Storage temperature limits Keep dry Do not use if the package is damaged Protection indice the capsule resist to a prolonged immersion Device CE marked Contra indicated for pregnant women Contain phtalates Do not pu...

Page 31: ...01 User guide eCelsius Performance Connect 1 EN Compliant with FCC regulation Forbidden under 18 years old Electronic user guide Non ionising electromagnetic radiation Keep out of reach for children Serial number ...

Page 32: ... the system operation that is not included into the user guide please contact BodyCAP Team BodyCAP 3 rue du Docteur Laënnec 14200 Hérouville Saint Clair FRANCE 33 0 2 61 53 03 29 contact bodycap medical com www bodycap medical com ...

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