BIOSENCY Bora band BB100 User Manual
Connected oximeter & heart / respiratory rate smart band monitor
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- User manual (44 pages) ,
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- Quick user manual (2 pages)
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Summary of Contents for BIOSENCY Bora band BB100
- Page 1 / respiratory rate smart band monitor Bora band® Model BB100 User manual Pulse Oximeter ™ 2797 BORA-Band_IFU-6.0 – DATE : June 2023 BIOSENCY BB100 VERSION 6.0 1137 A Avenue des champs blancs June 2023 A changer 35510 Cesson Sévigné AxxZZZ...
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Page 2: Table Of Contents
TABLE OF CONTENTS Introduction ......................4 About this user manual ........................4 Intented use ............................4 Target population ..........................5 Contraindications ..........................5 Side effects .............................6 About Bora band® technology ......................6 Bora band® Model BB-100 presentation ............7 Standard Bora band®kit ........................8 Equipment ...............................8 Bora band® identification ........................8 Pairing the Bora band®... - Page 3 Cleaning and disinfection between patients ..........20 Disinfecting the casing ........................20 Storage .........................20 Repair ........................21 Bora band® default status ......................21 When to consult a healthcare professional ..........21 Guarantee and Support..................21 Guarantee exclusions ........................22 Guarantee disclaimer/exclusivity ....................22 Incidents ..............................22 Disposal ..............................22 Cybersecurity ......................23 ..................24 Technical Information Specifications ............................24...
- Page 4 Table of figures Figure 1 : Bora band® presentation .....................7 Figure 2 : Bora band® identification number ................8 Figure 3 : Pair a Bora band® ......................9 Figure 4 : Fastening the fabric wristband ................10 Figure 5 : Adjusting the length of the fabric wristband ............. 11 Figure 6 : Wearing the Bora band®...
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Page 5: Introduction
Failure to follow the instructions in this manual may result in mal- functions, including inaccurate readings. The Bora band ® device should only be used with the equipement supplied by Biosency and the applications de- veloped by Biosency or its partners. -
Page 6: Target Population
ELECTROSURGERY Do not use the Bora band ® during electrosurgery. FLAMMABLE SUBSTANCES To avoid the risk of explosion, do not use the Bora band ® in the presence of flammable anaes- thetics or other flammable substances, or within oxygen- or nitrous oxide-enriched environments. COMPLEMENTARY DEVICE FOR PATIENT DIAGNOSIS This device should be used in conjunction with other methods for the assessment of symptoms and clinical evidence. -
Page 7: Side Effects
WARNINGS ALARM Do not use the device when alarms are required. CONTINUOUS MONITORING Do not use the Bora band ® for continuous monitoring purposes. The Bora band ® is intended to periodically record physiological parameters (SpO2, respiratory rate, heart rate, temperature). No alarm is provided to allow continuous monitoring. -
Page 8: Bora Band® Model Bb-100 Presentation
Figure 1 Hardware overview Bora band® Model BB-100 presentation 1. B 1. BORA Ban 2. W 2. Wristband 3. P 3. Push butto 4. L 4. LED indica Figure 2 Charging the BORA Band 5. S 5. SpO2 sen 6. Th 6. -
Page 9: Standard Bora Band®Kit
E1 BB100UC, micro USB cable E1 BB100IFU, User manual (this document) E1 BB100QUG, Quick user guide (patient) Equipment The Bora band ® cannot be used with elements other than those supplied by Biosency. Model number Description BB100DC AC adaptor, IEC 60601-1-2 compliant... -
Page 10: Pairing The Bora Band® With The Mobile Application
The installation of the application and pairing of Bora band ® are already done by your healthcare provider or by the Biosency team since you are using a Bora box™, a mobile phone provided and configured befo- rehand by Biosency. -
Page 11: Partner Mobile Application
3. Push button 4. LED indicato 5. SpO2 senso 6. Thermal sen In order for data transfer to take place, make sure that Bora band ® is in the same room and close to (less than 10 metres) the laptop or tablet to which it is connected. Data access for patient It is possible to check the correct functioning of the service thanks to the mobile application: it must indicate that Bora band ®... -
Page 12: Fabric Wristband Adjustment
ue du dessous Modelo Número de série Fabric wristband adjustment Figure 4 Adjust the wristband length Adjust the size of the wristband as illustrated in Figure 5 below. 2/ Resserrer les deux scratchs Enfiler le bracelet EUndo the fabric strap’s Velcro fastening and adjust to the size of your wrist, then simply secure back in place. - Page 13 WARNINGS ALLERGIES This device should not be used by people with known allergies to the fabric strap material (polya- mide) or case (Polycarbonate / ABS - SEBS). SKIN SENSITIVITY Monitor the skin contact area closely to ensure no sensitivity occurs. If irritation occurs, check the cleanliness of the sensor, and clean the device if necessary.
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Page 14: Taking Off The Bora Band
Modelo Número Modelo Número de série Taking off the Bora band® To release, undo the Velcro fastenings on both sides of the fabric strap (as shown in Figure 7). Figure 6 - Taking off the BORA Band Figure 6 - Taking off the BORA Band ORA Band Figure 7 : Removing the Bora band ®... - Page 15 WARNING TROUBLESHOOTING If the device does not perform as expected, refer to the Repair section or discontinue use and contact a sales representative. PRECAUTIONS EXPOSURE TO LIQUIDS Do not submerge the device in water or any other liquid solution as this will cause permanent damage. SKIN TEMPERATURE The Bora band ®...
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Page 16: Turning Off The Bora Band
Turning off the Bora band ® Stop the device by pressing button (3) until the green indicator light (4) flashes. This indicates that the Bora band ® is turning off. Malfunction In the event of malfunction : EStop using the device immediately. ETry to identify or eliminate the cause using this document (see Repair section). -
Page 17: Figure 9 : Battery Charging
2/ First step, plug one end of the micro USB 1/ Provided accessories cable into the USB port of the AC adaptor Figure 2 Charging the BORA Band Device charging To charge the device, proceed as explained in the figure below. Figure Figure 3 Attach Figure 2 Charging the BORA Band... - Page 18 BATTERY CHARGING Do not wear the device while charging. CHARGER Use only the BB100DC AC adapter supplied by Biosency. The use of an unauthorised charger may cause an electric shock. If the AC adapter is damaged, contact a sales representative. BATTERY The battery may leak or explode if not used or disposed of in accordance with regulations.
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Page 19: Indicator Light Signification
Indicator light signification In order to be as discreet as possible, the Bora band ® indicator light goes out once it has started up. The Bora band ® indicator light will be off most of the time. A fixed GREEN light indicates that the device is in operation. A flashing GREEN light indicates that the device is switching off. -
Page 20: Data Access For Health Professionals
Data access for health professionnals The mobile application, once installed on a mobile phone or a tablet, and connected to your Bora band ®, allows you to send data to healthcare professionals on a Bora connect ® web platform or a partner’s platform. To learn more about the visualization of physiological data and the setting of accounts as well as alert thresholds, please refer to the user manual of the Bora connect ®... -
Page 21: Cleaning And Disinfection Between Patients
CLEANING - MULTI-USAGE FOR DIFFERENT PATIENTS If the Bora band ® is used successively by different patients, the bracelet must be changed and the Bora band ® casing should be cleaned as directed by Biosency. PRECAUTIONS STERILISATION Do not sterilise using autoclaves, irradiation, gas, ethylene oxide or any other method. -
Page 22: Repair
Guarantee and Support As part of its sales or rental contract, Biosency offers customers a two-year guarantee for the Bora band ® - Model BB100. This is effective from the date of purchase or for the duration of the rental contract. In ac- cordance with this guarantee, Biosency will repair or replace any faulty Bora band ®... -
Page 23: Guarantee Exclusions
Consequently, should there be any sign or proof that a Bora band ®, Model BB100, has been opened or repaired by people outside of the Biosency company, the guarantee will be deemed null and void. The same applies to any alterations or improper use of the Bora band ® Model BB100. -
Page 24: Cybersecurity
Cybersecurity This chapter provides a set of precautions and warnings to guard against cybersecurity risks. In order to guarantee the confidentiality, integrity and security of your personal data, you are strongly advised to read the information below. For more information, we invite you to consult this page describing the security management of our platform: https://doc.bora-connect.com/wp-content/uploads/2023/06/Bora-care-security-description.pdf WARNING IT RISK... -
Page 25: Technical Information
). Two thirds of measurements made by the device will have an error less than the average root mean square error (A The Bland and Altman plot (i.e., (SpO2- SaO2) versus SaO2) are available at biosency.com/clinique/#Vc. VERSION 6.0 June 2023... -
Page 26: Equipment Response Time
Equipment response time Equipment delay Delay time Display time delay on The data measured by the Bora band ® Model BB100 is time stamped Bora connect ® and transmitted via BLUETOOTH ® to the mobile application. The Bora connect ® display takes into account the time stamp for measurements. The date of the displayed measurements is therefore the effective date and there is no difference between the date on which the measurement is taken, and the date displayed on the Bora connect ®. -
Page 27: Environmental Conditions
Environmental conditions Working conditions Environmental temperature: +10°C to +38°C. Skin temperature : ≥ 24°C. Relative humidity: 0% to 90 %, without condensation ; Atmospheric pressure : 700 hPa to 1,060 hPa. The temperature of the device should not exceed 43°C, when measured. in a controlled environment. -
Page 28: Wireless Transmission
Wireless transmission Bluetooth conformity BLUETOOTH® LOW ENERGY 4.2 Operating frequency 2,4 to 2,483 GHz Output power <10dBm Operating range 10 m range indoors Network topology Point to point Operation Slave Antenna type Internal Modulation technique Frequency shift modulation Frequency-hopping spread spectrum modulation Bandwidth 1 MHz, 2MHz Operating principles... - Page 29 Benefits Population Source Results Quality of Patient compliance BPCO DACRE clinical trial Mean patient compliance of patient care Brinchault, G., et al. "Évo- 90% (95% CI : [87% - 92%]) improvement lution des signes vitaux en vie réelle de patients BPCO: facteurs préventifs d’une réadmission après une hospitalisation pour...
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Page 30: Manufacturer's Declarations
The use of accessories other than those specified or sold by Biosency as replacement parts, may result in an increase in emissions or a decrease in the medical device’s immunity. - Page 31 Table 1: Electromagnetic emissions Emission test Conformity Electromagnetic environment - notes This medical device is intended for use in the electromagnetic environment described in this table. The user and installer should therefore ensure that the medical device is used in such an environment. Electromagnetic Radiation Disturbance Group 1 The medical device uses RF energy for its internal functio-...
- Page 32 Table 3: Manufacturer’s declarations and notes - electromagnetic immunity Electromagnetic Level of Immunity test IEC test level 60601 conformity environment - notes This medical device is intended for use in the magnetic and electromagnetic environment described in the table below. The user and installer should ensure the compliance of the electromagnetic environment.
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Page 33: Copyrights And Trademarks
Pulse Oximeter 2797 The BLUETOOTH® brand and logos are registered trademarks of Bluetooth SIG, Inc. BB100 mps blancs Bora band ® and Bora connect ® are registered trademarks of Biosency in France and Europe. A changer AxxZZZ Pulse Oximeter ™... -
Page 34: Manufacturer's Contact Details
Pulse Oximeter 2797 BIOSENCY BB100 1137 A Avenue des champs blancs A changer 35510 Cesson Sévigné AxxZZZ BB100 Avenue des champs blancs + 33 (0)9 73 24 88 10 mm/yyyy A changer Cesson Sévigné AxxZZZ 9 73 24 88 10 Rating : 3.7 VDC... - Page 35 This QR code will give you access to an electronic version of this user manual.
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