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Related Manuals for BodyCAP e Celsius
Summary of Contents for BodyCAP e Celsius
- Page 1 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Medical Connect System P0 73 ME AS UR ING SYST EM R EL I AB L E AND ACC URAT E CONT INUOUS GA STR OI NT ESTI N AL CORE TEMPERAT URE RE COR D ING BY T ELEME TRY USER MANUAL Year of affixing the CE mark: XXXX...
- Page 2 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Please read this manual carefully before using the medical device as it contains important information for you.
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Page 3: Table Of Contents
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN TAB L E O F C ONT ENTS 1. PRECAUTIONS FOR USE 2. CLAIMS FOR USE OF CONTRAINDICATIONS Claims of use Contraindications and Warnings Risks and complications e-Celsius® Medical System Features 3. - Page 4 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Installing e-Celsius Mobile The main display of the application Pairing e-Med Connect & e-Celsius Mobile Main functions e-Med Connect configuration on e-Celsius Mobile Association of a capsule Ingestion of the capsule View temperature data in real time View temperature graphs Automatic synchronization of the data in the capsule’s memory...
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Page 5: Declaration Of Conformity
Thank you for purchasing the e-Celsius® Medical Connect System. This medical device is manufactured by BodyCAP. This manual is designed to introduce you to the features and operation of your system and to assist you in the setup and using this product. The use of this device does not require any special training or specific skills;... - Page 6 CAUTION : This equipment may not be modified, altered, or changed in any way wit- hout signed written permission from BodyCAP. Unauthorized modification may void the equipment authorization from the FCC and will void the BodyCAP warranty. This device complies with FCC RF radiation exposure limits set forth for general popu- lation (uncontrolled exposure).
- Page 7 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Warning to users in the CANADA This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
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Page 8: Precautions For Use
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN 1. PRECAUTIONS FOR USE The following safety instructions will ensure proper operation and optimal use of the e-Celsius® Medical Connect System. For questions not answered in the manual, please contact your distributor or the manu- facturer (see the contact information at the end of the document). - Page 9 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Storage/Transport Temp °C Humidity Pressure HPa Temp °C Humidity Pressure HPa P022 Capsules 5-35°C 30%-80% 700-1060hPa 25-45°C 700-1060hPa 5-35°C 30%-80% 700-1060hPa 5-40°C 15% - 90% 700-1060hPa P110 Watch 0-45°C 30%-80% 700-1060hPa 5-40°C 30%-80%...
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Page 10: Claims For Use Of Contraindications
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Presence of phthalates Based on the toxicological evaluation, we inform users that there is an acceptable level of recovered phthalate without toxicological risk to the individual in the e-Celsius® Medical capsule. •... -
Page 11: Risks And Complications
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Warnings Since the e-capsule Celsius Medical must be ingested by the patient, special attention should be paid to, as described below: - The e-Celsius® Medical capsule (Fig.1) is intended to be ingested with a glass of water to measure the temperature. -
Page 12: Possible Complications
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN • Loss of traceability (patient/capsule) • Loss of sterility of the device induces an infectious risk. • Loss of communication between the e-Celsius® Medical capsule and the e-Med Connect receiver watch, resulting in the interruption of the patient’s temperature monitoring. - Page 13 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN The system is based on the principles listed in Table 3. N° Operating principle The e-Celsius® Medical capsule is activated by an electromagnetic pulse emitted by the activator The e-Celsius® Medical capsule measures temperature using a Silicon Bandgap temperature sensor The e-Celsius®...
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Page 14: Presentation Of The Materiel
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Instant visualization of triggered alarms (technical or physiological) through the LED and the screen for the watch and on the application Automatic data transfer via BLE from the e-Med Connect watch to the Android device via the e-Celsius Mobile application Visualization of data on the e-Celsius Mobile application in real time and its history Integration of a manual marker via the e-Med Connect watch... - Page 15 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN The battery The e-Celsius® Medical capsule includes 4 batteries (zinc oxide - silver). In fact, the capsules should not be thrown away with the household waste. Cleaning The capsule is delivered sterile (ethylene oxide sterilization) and must be activated through the blister to maintain its sterile state.
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Page 16: The Characteristics
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN The label contains an IEC 60601-1-2 symbol: "Radiated RF disturbances" The label contains a symbol of linked to regulation 2017/745, relating to medical devices, "Medical Device according to Regulation 2017/745" The label contains an IEC 60601-1 symbol: "Follow the using instructions"... -
Page 17: The Singular Bracelet
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Protection Index (IP): X8 (Matériel supportant l’immersion prolongée) Alimentation: X8 (Material supporting prolonged immersion) Power supply: Autonomous system containing zinc-silver oxide batteries. Autonomy: 20 days Contact time with the person: 2±1.5 days on average, up to 6 days depending on individual gastrointesti- nal motility characteristics. -
Page 18: Important Information And Safety Instructions
Maintenance It is strictly forbidden to open the activator. If a fault or malfunction is found, please contact your distributor or BodyCAP (contact details at the end of the user manual). The label The label contains the following symbols of the NF EN ISO 15223-1 standard: "Serial number"... -
Page 19: Micro-Usb Connector
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN "Humidity level" "Atmospheric pressure" "Medical Device according to Regulation 2017/745" "FCC ID" "Do not use if packaging is damaged" "Electronic manual" FEATURES OK Bouton Hole for place the capsule Green LED micro-USB connector Figure 4: Description of the activator... -
Page 20: The Button
Maintenance It is strictly forbidden to open the e-Med Connect watch. If a malfunction or defect is found, please contact your distributor or BodyCAP (contact details at the end of the user manual). RF (Radio Frequency) communication In operation, the watch should be worn on the wrist of the patient who has ingested an e-Celsius Medical. - Page 21 XXXX "CE marked medical device" Do not dispose of the device with municipal waste (> Precautions for use - page 6 ) A QR code with the following information: BodyCAP Gateway Ref: P110 SN: XXXX Year of manufacture: AAAA https://www.bodycap-medical.com/ The label on the box contains the following symbols: "Catalog reference"...
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Page 22: The Characteristics
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN "Follow the instructions for use" "Humidity level" "Atmospheric pressure" "Medical Device according to Regulation 2017/745" "FCC ID" "Do not use if packaging is damaged" "Electronic manual" "Keep out of reach of children" DESCRIPTION OF THE EQUIPMENT Button 2 Button 1... -
Page 23: The Buttons
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Charge time: ≈ 3 h. Autonomy: ≈ 5j IP rating: 67 Communication frequency: ISM 433MHz ›› 434MHz. Bluetooth Low Energy 4.x ou 5.x Lifetime: 2 years (or about 500 recharge cycles). Transport and storage conditions: refer to table 1 Means of disconnecting the power supply: Disconnect the power cable Power Input: 100-240V... -
Page 24: The Charging Cable
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN While the battery is charging, the battery logo on the watch changes to a plug symbol and a fixed level (indicating the state of charge, not the battery level). Once the cable is disconnected, the logo returns to normal and represents the actual percentage of the battery. -
Page 25: The E-Celsius Mobile Application
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Time display (24h or 12h format) If the symbol --- appears instead of the time, it is necessary to reconnect to the e-Celsius Mobile to send a date and time reference. The application will send to the watch the 12 or 24h format according to the settings applied on the mobile object. -
Page 26: Principles Of Operation
The e-Med Connect watch is delivered turned off. To take it out of shelf mode, you must turn on the system by pressing and holding button 1 (on the edge of the BodyCAP side). This procedure turns on the screen of the watch. -
Page 27: The Main Display Of The Application
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN THE MAIN DISPLAY OF THE APPLICATION The application is based on 3 features represented at the bottom of the pages by logos. Profile filter Add a profile Archives Viewing active profiles Display of the parameters for former data visualization Main page... -
Page 28: Main Functions
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Figure 10: e-Med Connect BLE pairing with e-Celsius Mobile MAIN FUNCTIONS e-MED CONNECT CONFIGURATION ON e-CELSIUS MOBILE Before using the watch with a capsule, it is necessary to configure some parameters. To do this, please go to the watch settings options using the nut located on the main screen below the concerned profile. -
Page 29: Association Of A Capsule
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN COMBINATION OF A CAPSULE In order to associate an e-Celsius® Medical capsule, please have all the system elements ready: * the activator and its cable * the e-Med Connect watch which is turned on without the watch cable removed * the e-Celsius Mobile application which is launched and paired with the watch * a new e-Celsius Medical capsule Note: the application and the watch must be connected to launch an association. -
Page 30: Ingestion Of The Capsule
The direction of the watch does not matter, but for the wearer's comfort, it is recommended to position the BodyCAP logo on the arm side and not on the hand side. CONSULT THE TEMPERATURE DATA IN REAL TIME In order to consult the collected temperature data, the watch and the application must be able to communicate via BLE. -
Page 31: View Temperature Graphs
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN CONSULT THE TEMPERATURE GRAPHS The temperature data of the capsules can also be visualized in graphic form. To do this, simply click on a capsule temperature to display the corresponding graph or on the generic temperature of the profile to display the graph of all the associated capsules. -
Page 32: Automatic Synchronization Of The Data In The Capsule's Memory
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN * the number of missing data between the watch and the capsule (indicator that the communication with the capsule needs special attention) * The elapsed time (hh:mm:ss) since the last real time data * The adjustable thresholds of physiological alarms are also recalled. -
Page 33: Visualization Of The End Of Life Of The Capsule
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN * the display of the °C! symbol at the top left of the watch's display * the symbol on the profile and on the concerned capsule * the min or max associated with the cap in Red or Blue color * a notification on the phone/tablet if it is connected in real time BLE to the watch The delay inherent in the determination of an alarm condition is a maximum of 30 seconds in the case of real-time communication between the capsule and the watch. -
Page 34: Secondary Functions
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN SECONDARY FUNCTIONS VIEWING OF CAPSULE IDENTIFIERS It is possible to know the unique identifier of the capsules by going to e-Celsius Mobile and viewing the watch parameters (Nut). Capsule identifiers are given in hexadecimal form: XX.XX.XX.XX where X can go from 0 to 9 and A to F. -
Page 35: The Pause Mode Of A Capsule
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Low battery alarm The watch triggers its low battery alarm Threshold slot alarm (1/2/3) Physiological alarm triggered Alarm reset The physiological alarm is reset for all capsules of this watch Change of thresholds Modification of the alarm thresholds Change of thresholds... -
Page 36: Archive Management - Old Capsules
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN ARCHIVE MANAGEMENT - FORMER CAPSULES A deactivated capsule will automatically be placed in the corresponding folder in the application's archives. It will be filed under the name of the profile to which it was associated and sorted by activation date and serial number. -
Page 37: Switching Off The E-Med Connect Product
UPDATING THE WATCH It is possible to update your e-Med Connect watch if a new software version has been provided by BodyCAP. To do so, please go to the available settings on e-Celsius Mobile for the concerned e-Med Connect watch. - Page 38 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN e-Celsius Delay due to the e-Med Connect alarm Controlled function Alarm conditions Mobile alarm Priority alarm condition mode mode 30 seconds max. in case of real time Notification + The measured tem- communication 10 Temperature of the perature exceeds...
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Page 39: End Of Follow-Up
P030 (Activatorr) Important: Information about electromagnetic compatibility (EMC) Medical devices manufactured by BodyCAP comply with the IEC60601-1-2:2014 standard for immunities and emissions. All the information given below is based on the normative requirements to which manufacturers of elec- tro-medical devices are subject, as defined in the IEC60601-1-2 Ed4 standard. The medical device com-... -
Page 40: Cable Length
The use of accessories other than those specified or sold by BodyCAP as replacement parts may result in increased emission or decreased immunity of the medical device. - Page 41 P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN Guidelines and manufacturer's declaration of conformity regarding electromagnetic immunity The e-Celsius® Medical System is intended for use in the magnetic and electromagnetic environment described in the table below. The user and installer should ensure compliance with the electromagnetic environment.
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Page 42: Material-Vigilance Declaration
BodyCAP or to the "Agence nationale de sécurité du médicament et des produits de santé". -
Page 43: 8. Trouble Shooting Guide
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN 8. TROUBLE SHOOTING GUIDE Problem Probable cause Solution Connect the watch using the dedi- The battery of the watch is discharged cated USB cable. The date of manufacture is written The watch does not turn on on the label. - Page 44 If you have any questions about the operation of the system that are not answered in the user manual, contact BodyCAP: BodyCAP 3, rue du Docteur Laënnec 14200 Hérouville Saint Clair FRANCE +33. (0)2 61 53 08 14 support@bodycap-medical.com www.bodycap-medical.com...
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