BIOSENCY BORA Band BB-100 User manual

Connected oximeter &
heart / respiratory rate smart band
monitor
Bora band® Model BB100
User manual
2797
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BORA-Band-IFU-FR-4.0 – DATE: September 2022
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TABLE OF CONTENTS
TABLE&OF&CONTENTS&
Introduction .................................................................................................................................................. 3
About
this user manual ........................................................................................................................................... 3
Intended use ............................................................................................................................................................ 3
Target population: ................................................................................................................................................... 4
Contraindications ..................................................................................................................................................... 4
About
Bora band® technology ................................................................................................................................. 5
Bora band® Model BB-100 presentation ....................................................................................................... 6
Standard Bora band® kit ........................................................................................................................................... 7
Accessories .............................................................................................................................................................. 7
Bora band® identification ......................................................................................................................................... 7
Pairing Bora band® with the mobile application ........................................................................................... 8
Wearing the Bora band® ............................................................................................................................... 8
Fastening the BB100S fabric wristband ..................................................................................................................... 8
Fabric wristband adjustment .................................................................................................................................... 9
Positioning the Bora band® ...................................................................................................................................... 9
Taking off the Bora band® ...................................................................................................................................... 11
How the Bora band® works ......................................................................................................................... 11
Starting the Bora band® ......................................................................................................................................... 11
Turning off the Bora band® .................................................................................................................................... 13
Malfunction ........................................................................................................................................................... 13
Battery charging ..................................................................................................................................................... 13
Indicator light signification ..................................................................................................................................... 16
Bora band® software update ...................................................................................................................... 16
Data transfer .............................................................................................................................................. 17
Data access ................................................................................................................................................. 17
Patients .................................................................................................................................................................. 17
Cleaning ..................................................................................................................................................... 17
Cleaning the case ................................................................................................................................................... 17
BB100S fabric wristband cleaning ........................................................................................................................... 17
Cleaning and disinfection between patients ................................................................................................ 18
Disinfecting the casing ........................................................................................................................................... 18
Storage ....................................................................................................................................................... 18
Repair ......................................................................................................................................................... 19

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Bora band® default status ...................................................................................................................................... 19
When to consult a healthcare professional ................................................................................................. 19
Guarantee and Support .............................................................................................................................. 19
Guarantee exclusions ............................................................................................................................................. 20
Guarantee disclaimer/exclusivity ........................................................................................................................... 20
Incidents ................................................................................................................................................................ 20
Disposal ................................................................................................................................................................. 20
Cybersecurity .............................................................................................................................................. 21
Technical information ................................................................................................................................. 22
Specifications ......................................................................................................................................................... 22
Performance .................................................................................................................................................................................. 22
Equipment response time ............................................................................................................................................................. 23
System ........................................................................................................................................................................................... 23
Electrical information .................................................................................................................................................................... 23
Physical characteristics .................................................................................................................................................................. 23
Environmental conditions .............................................................................................................................................................. 24
Conformity ..................................................................................................................................................................................... 24
Wireless transmission .................................................................................................................................................................... 25
Operating principles ............................................................................................................................................... 25
Clinical benefits .......................................................................................................................................... 25
Manufacturer’s declarations ....................................................................................................................... 26
Copyrights and Trademarks ........................................................................................................................ 29
Symbols ...................................................................................................................................................... 29
Manufacturer’s contact details ................................................................................................................... 30
This QR code will give you access to an electronic version of this user manual. ...................................................... 31
Table of figures
Figure 1: Bora band ® presentation ............................................................................................ 5
Figure 2: Bora band ® identification number ......................................................................... 6
Figure 3: Fastening the fabric wristband .................................................................................... 7
Figure 4: Adjusting the length of the fabric wristband ........................................................ 8
Figure 5: Wearing the Bora band ® ............................................................................................ 8
Figure 6: Removing the Bora band ® ....................................................................................... 10
Figure 7: Turning on the Bora band ® ..................................................................................... 10
Figure 8: Battery charging ............................................................................................................... 12

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MAGNETIC RESONANCE IMAGING
Do not use the Bora band ® during surgery or in a magnetic resonance imaging (MRI) setting.
DEFIBRILLATION
Do not use the Bora band ® during defibrillation procedures as this device is not shock proof (in
accordance with IEC 60601-1).
Introduction
About this user manual
This manual is a user guide for the Bora band ® Model BB100 pulse oximeter, designed by Biosency.
Please do not use the Bora band ® pulse oximeter without first reading and understanding all of the
instructions contained within.
Please always use the Bora band ® in accordance with the instructions contained within this manual, which
includes where to locate and place the oximeter. Failure to follow the instructions in this manual may result
in malfunctions, including inaccurate readings.
The Bora band ® device should only be used with the accessories supplied by Biosency and the
applications developed by Biosency or its partners.
To ensure safe and optimal use of the device, please carefully read the precautions for use marked with an
s symbol.
Intended use
Bora care ® is a non-invasive device worn on the wrist and is used for monitoring, displaying, and storing
information relating to:
- functional oxygen saturation of arterial haemoglobin (%SpO2),
- heart rate (HR),
- respiratory rate (RR),
- skin temperature (T°C).
The Bora care ® solution includes:
- The Bora band ®: a smart bracelet, oximeter and heart and respiratory rate monitor.
- a mobile application allowing the transmission of data to the Bora connect ® platform
- Bora connect ®: a platform for displaying data.
The Bora band ® pulse oximeter is suitable for use with adult patients when active or at rest, and for
patients with satisfactory perfusion.
It is intended for use at home, outdoors, and within medical settings.
WARNINGS

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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.
Target population:
The device, which is prescribed by a doctor, is intended to measure the cardio-respiratory parameters of
patients suffering from respiratory failure, in particular patients with chronic obstructive pulmonary disease.
The patients are adults with a satisfactory blood supply.
The BORA device is intended for use by several types of users:
1. Patients wear the BORA band bracelet. They can consult their data on a mobile version of BORA Connect
(except with BORA Connect for Research/BORA Connect for Home).
2. Medical staff have access to patient data collected by BORA Band using the BORA Connect web version.
3. The client structure (e.g. home care provider) has access to BORA Band status information (device in use
or available for use, battery level, etc.) using the BORA Connect web version.
Contraindications
The Bora band ® does not trigger an alarm and does not allow for continuous readings.
The Bora band ® is not designed to continuously monitor patient vital signs. The Bora band ® is
not intended for use in patients with low perfusion.
WARNINGS
ELECTROSURGERY
Do not use the Bora band ® during electrosurgery.
FLAMMABLE SUBSTANCES
To avoid any risks of explosion, do not use the Bora band ® in the presence of flammable
anaesthetics 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.

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About Bora band® technology
The Bora band ® pulse oximeter is a communication device designed to be worn on the wrist and acquire
real-time readings several times a day, while maintaining user comfort at all times.
The Bora band ® has three sensors:
- A photoplethysmography (PPG) sensor, for measuring SpO2 and heart rate
- A 6-axis inertial measuring unit, to count steps, monitor physical activity and measure respiratory rate
- A thermal sensor, to measure skin temperature
The Bora band ® stores data in an internal memory. The data is then transmitted using Bluetooth® Low
Energy technology.

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Bora band® Model BB-100 presentation
1
4
3
2
6 1
1 4
3 7 3
5
1
Case
2
Fabric wristband
3
Button
4
Indicator light
5
SpO2 and heart rate
sensor window
6
Temperature sensor
7
Micro-USB type B Port
Figure 1: Bora band ® presentation
4
1
7
2

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ELECTROMAGNETIC INTERFERENCE
The use of accessories, transceivers, and cables, other than those listed in this manual, may result in
increased electromagnetic emissions and / or decreased immunity of this device. As a result, this may
lead to malfunction.
Standard Bora band® kit
The standard Bora band ® kit includes the parts and accessories listed in the Accessories paragraph.
Upon delivery, please ensure that the following parts and accessories are present. Please contact the
carrier immediately if the package is damaged.
Kit equipment:
1 Bora band ®, smart bracelet, oximeter and heart and respiratory rate sensor
1 BB100S, fabric bracelet
1 BB100DC, AC adapter conforming to IEC 60601-1-1
1 BB100UC, micro USB cable
1 BB100IFU, User manual (this document)
1 BB100QUG, Quick user guide (patient)
Accessories
The Bora band ® cannot be used with accessories other than those supplied by Biosency.
Model number
Description
BB100DC
AC adaptor, IEC 60601-1-1 compliant
BB100UC
Micro USB cable
BB100S
Fabric wristband
WARNINGS
Bora band® identification
The unique device identification number is listed on the base of your device. It refers to
the serial number indicated in Figure 2.
Figure 2: Bora band ® identification number
Model Serial number

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Pairing Bora band® with the mobile application
This must be carried out by a qualified professional.
For data transmission, download and install the dedicated mobile application on a phone or tablet.
The Bora band ® will then need to be paired with this phone or tablet.
It is possible to check the correct functioning of the service using the mobile application: this should indicate
that the Bora band ® is connected.
Wearing the Bora band®
Fastening the BB100S fabric wristband
Figure 3 shows how to attach the wristband to the Bora band ® case.
Figure 3: Fastening the fabric wristband

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1 cm
Fabric wristband adjustment
Adjust the size of the wristband as illustrated in Figure 4 below.
Undo the fabric strap’s Velcro fastening and adjust to the size of your wrist, then simply secure back in
place.
To ensure optimal comfort and reading accuracy, make sure the Bora band® fits snugly on your wrist
(neither too tight nor too loose).
Figure 4: Adjusting the length of the fabric wristband
Positioning the Bora band®
The Bora band ® is worn on the back of the forearm, slightly below the wrist bone, as illustrated
below in Figure 5. This placement ensures optimal comfort and reading accuracy.
The Bora band ® can be worn on the left or right wrist.
Figure 5: Wearing the Bora band ®

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FACTORS THAT MAY NEGATIVELY EFFECT PULSE OXIMETER READINGS:
INCORRECT PLACEMENT OF STRAP
Ensure the device is placed 1 cm from the wrist bone.
WARNINGS
ALLERGIES
This device should not be used by people with known allergies to the fabric strap material
(polyamide) 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. Should the problem persist, please
contact a sales representative.
FASTENING TOO TIGHT ON THE WRIST
Do not over tighten the device on the wrist. Fastening the device too tightly can cause
discomfort.
FACTORS THAT MAY NEGATIVELY EFFECT DEVICE PERFORMANCE: INCORRECT
FASTENING TO THE WRIST
The wristband must be tight enough so that it does not slide on the skin but should not cause any
compression marks. Too tight or too loose a fastening can negatively affect the device’s
performance.
FACTORS THAT MAY NEGATIVELY AFFECT THE PERFORMANCE OF THE PULSE
OXIMETER: SIGNIFICANT TATTOOS OR EXCESS HAIR
Do not place this device on a tattoo or an area with significant hair growth. A tattoo or
excess hair can cause inaccurate readings.
PRESENCE OF BRUISING ON THE WRIST
Should bruising appear where the bracelet has been placed, move to the other wrist.
PRECAUTIONS

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Taking off the Bora band®
To release, undo the Velcro fastenings on both sides of the fabric strap (as shown in Figure 6).
Figure 6: Removing the Bora band ®
How the Bora band® works
Starting the Bora band®
Make sure that the device is not connected to the mains, then simply start by pressing button (3). The
indicator light (4) turns green for 5 seconds, indicating that the Bora band ® is starting up.
What you should do
What you will see
What it means
Press button (3)
Off LED (4) GREEN Off
fixed during
5 seconds
Bora band® has
started
4 Indicator light
3 Button
Figure 7: Switch on the Bora band ®
Once switched on, the Bora band ® automatically collects and records readings for oxygen saturation (SpO2)
levels, heart rate, respiratory rate, skin temperature, number of steps and activity.
In order to be as discreet as possible, the Bora band ® indicator light (4) goes out once it has started up.

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TROUBLESHOOTING
If the device does not perform as expected, refer to the Troubleshooting section or discontinue use and
contact a sales representative.
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 ® pulse oximeter may not work if the skin temperature is too low. Make sure that the
skin temperature at the area of application is 24°C or above.
FACTORS THAT MAY NEGATIVELY EFFECT PULSE OXIMETER READINGS
This device is intended to determine the amount of oxygen-carrying haemoglobin in the blood. Some
factors may negatively affect the oximeter’s performance or reading accuracy. These include:
•Movement
•Moisture in the sensor
•Electrosurgical interference
•Restricted blood circulation (arterial catheters, blood pressure cuffs, infusion tubing
etc.)
•Anaemia or low haemoglobin levels
•Weakened pulse rate
•Indocyanine green or other intravascular dyes
•Carboxyhaemoglobin
•Methaemoglobin
•Dysfunctional haemoglobin
•Venous pulsations
•Residue on the sensor window (5)
WARNING
PRECAUTIONS

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1/ Accessories
included
2 / Connect one end of the micro-USB
cable to the power adapter
3 / Connect the other end of the micro-USB
cable to the Bora band’s ® USB port
4 / Connect to the power supply
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 Troubleshooting section).
EIf it is not possible to identify or eliminate the cause using this document, turn off the device
and call a sales representative.
Battery charging
Low battery indicator
The indicator light starts flashing ORANGE when the battery is low (less than 20% battery).
What you will see
What it means
What you should do
Flashing orange indicator
light
The battery is low
Charge the device as
described below
Device charging
To charge the device, proceed as explained in the figure below.

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Figure 8: Battery charging

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BATTERY CHARGING
Before charging the device, check that the micro-USB cable is not damaged. Use only the micro-USB
cable supplied by Biosency. If the micro-USB cable is faulty, contact a sales representative.
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. Do not
remove the battery.
What you will see
What it means
What you should do
Flashing WHITE indicator
light
The device is charging
Leave the device connected
to the power supply
Indicator light off
The device is fully
charged
Disconnect from the power
supply
Charging the Bora band ® takes approximately 2 hours.
The autonomy of the Bora band ® battery is more than 3 days.
NOTE:
1. If you are charging the device for the first time, or after a long period of storage (over 6
months), be sure to charge it for at least 2 hours.
2. This product should not be used in an environment which may cause electromagnetic interference.
3. During charging, the reading functions are disabled as a safety precaution.
WARNINGS

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Indicator light signification
In order to be as discreet as possible, the Bora band ® indicator light goes out once it has started up.
Bora band ®. 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
A fixed BLUE light indicates that the device is installing a software update
A flashing BLUE light indicates that the device is transmitting or receiving data via a
Bluetooth connection
A flashing ORANGE light indicates that the device battery is low
A RED light indicates that the device is faulty
A flashing WHITE light indicates that the device is charging
Bora band® software update
The Bora band ® updates automatically when it is switched on; during the update, the indicator light will be
blue. Be careful not to turn off the Bora band ® when the blue indicator light is on.
What you will see
What it means
What you should do
Fixed BLUE light
The device is installing
a software update
Do not turn off the
Bora band ®.

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Data transfer
The Bora band ® is designed to work with a mobile application. Once installed on a mobile phone or tablet
linked to your Bora band ®, the mobile application allows data to be transmitted to healthcare
professionals. Refer to the application's user manual for installation and usage instructions.
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
Healthcare workers and professionals
To view data, connect to the Bora connect ® platform or mobile application.
Patients
To check the status of your Bora band ®, connect to your mobile application. Some
mobile applications also allow you to consult your physiological data.
Cleaning
Cleaning the case
Wipe the device case with a soft cloth moistened with soapy water.
To avoid irreversible damage, do not use undiluted products such as bleach, or any other cleaning solution
not recommended in this leaflet.
Wipe with a soft cloth and allow to air dry. The surface cleaner should be used between individual patients
and as often as needed.
BB100S fabric wristband cleaning
To clean the fabric wristband, put it in the washing machine at 30°C. It is recommended to fold back the
ends of the wristband to protect the Velcro hooks. Allow to air dry.
The BB100S fabric wristband is for single patient use. It therefore should be changed
between patients.
NOTE: Detergents such as hand soaps and washing-up liquid dissolve dirt and
grease. You can clean the bracelet using these products (diluted in hot water).

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CLEANING
The Bora band ® should only be cleaned with the products specified in this manual. Using different
products could damage the device.
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.
STERILISATION
Do not sterilise using autoclaves, irradiation, gas, ethylene oxide or any other method. This could
seriously damage the device.
STORAGE
The battery is designed to be stored for less than 6 months. Beyond 6 months, the battery should be
charged fully.
Cleaning and disinfection between patients
The Bora Band is designed to be used multiple times by multiple users. To avoid the transmission of
bacteria, the client must ensure that the casing is properly disinfected before being worn by a new user.
Disinfecting the casing
If necessary, clean the device casing before disinfecting it. To do this, proceed as described in the previous
section.
Disinfect the device casing with a soft cloth moistened with a surface cleaner that is suitable for cleaning and
disinfecting medical devices.
To avoid irreversible damage, do not use undiluted products such as bleach, or any other cleaning solution
not recommended in this leaflet.
Wipe with a soft cloth and allow to air dry. The surface cleaner should be used between individual patients
and as often as needed.
WARNINGS
PRECAUTIONS
Storage
Store the device according to the specified environmental conditions. See the “Environmental conditions”
section for more information.
PRECAUTIONS

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Repair
Bora band® default status
What you will see
What it means
What you should do
If the fault persists
Fixed RED light
The memory is full
OR
A serious fault has
occurred.
1. Make sure that your latest
data has been transmitted.
If the indicator light does not go
out, proceed to the next step.
2. Turn off the device, and
then switch back on.
Contact your sales representative.
Indicator light goes
out when I press
the button
A fault may
have occurred.
1. Ensure the device
is working
If the indicator light does not turn on,
proceed to the next step.
2. Charge the device.
If the indicator light does not
come on after 5 minutes, contact
your sales representative.
When to consult a healthcare professional
If you have any new symptoms, or if your symptoms worsen, please contact your doctor.
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
accordance with this guarantee, Biosency will repair or replace any faulty Bora band ® - BB100 model free
of charge, provided it has been reported to Biosency by the customer with details of the device’s serial
number. For any defective Bora band ® - Model BB100 delivered to the customer, this warranty is the sole
and exclusive remedy available, whether that be as part of a contract, a claim for redress or required by
law.
This guarantee does not include the cost of sending the device to be repaired or replaced by Biosency.
Biosency is liable for the reshipment of a replacement device. Biosency reserves the right to charge a
repair fee (with guarantee) should the device not be found to be faulty.
No returned product will be accepted without a written agreement from Biosency or a return merchandise
authorisation (RMA) number.
This number will be provided by Biosency.
Any work carried out beyond the realm of the guarantee must be carried out in accordance with Biosency's
standard rates
(in effect at the time of delivery to Biosency).