BIOSENCY BORA Band BB-100 User Manual

Connected oximeter &
heart / respiratory rate smart
band monitor
Bora band® Model BB100
User manual
™ Pulse Oximeter
BIOSENCY
2797
BORA-Band_IFU-6.0 – DATE : June 2023
VERSION 6.0
June 2023 1137 A Avenue des champs blancs
35510 Cesson Sévigné
mm/yyyy + 33 (0)9 73 24 88 10
BB100
A changer
AxxZZZ
1
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® with the mobile application..................................9
Bora connect for home.......................................................................................................................9
Bora connect®.......................................................................................................................................9
Partner mobile application..............................................................................................................10
Wearing the Bora band®.................................................................................10
Fastening the BB100S fabric wristband......................................................................................10
Fabric wristband adjustment..........................................................................................................11
Positioning the Bora band®...........................................................................................................11
Taking off the Bora band®..............................................................................................................13
How the Bora band® works............................................................................13
Starting the Bora band®..................................................................................................................13
Turning off the Bora band®...........................................................................................................15
Malfunction...........................................................................................................................................15
Battery charging..................................................................................................................................15
Indicator light signification..............................................................................................................18
Bora band® software update..........................................................................18
Data access for health professionals..............................................................19
Cleaning................................................................................................................19
Cleaning the case................................................................................................................................19
BB100S fabric wristband cleaning................................................................................................19
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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
Technical Information..........................................................................................24
Specifications........................................................................................................................................24
Performance at rest............................................................................................................................... 24
Equipment response time...................................................................................................................... 25
System................................................................................................................................................... 25
Electrical information.............................................................................................................................. 25
Physical characteristics.......................................................................................................................... 25
Environmental conditions....................................................................................................................... 26
Conformity.............................................................................................................................................. 26
Wireless transmission............................................................................................................................ 27
Operating principles..........................................................................................................................27
Clinical benefits...................................................................................................27
Manufacturer’s declarations............................................................................29
Copyrights and Trademarks.............................................................................32
Symbols.................................................................................................................32
Manufacturer’s contact details........................................................................33
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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®........................................................................................... 11
Figure 7 : Removing the Bora band®........................................................................................ 13
Figure 8 : Turning on the Bora band®...................................................................................... 13
Figure 9 : Battery charging............................................................................................................. 16
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Introduction
About this user manual
This manual is a user guide for the Bora band ® Model BB100 wearable device, designed by Biosency.
s WARNINGS
INSTRUCTIONS FOR USE
Please do not use the Bora band ® wearable device 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 equipement 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 band ® is a wearable device used for measuring (intermittent data collection), recording, processing and
storing physiological parameters that will later be transmitted to a web platform for remote review to support the
follow-up of patient’s care. There is no display on Bora band ®. Bora band ® measures, records and processes :
Efunctional oxygen saturation of arterial hemoglobin (%SpO2),
Eheart rate (HR),
Erespiratory rate (RR),
Eskin temperature (T°C).
Bora band ® is suitable for use with adult with chronic respiratory diseases and satisfactory perfusion.
It is intended for use at home, outdoors, and within medical settings.
Bora band ® is intended to be used in combination with one of the following platforms: Bora connect ®, EPOCA
(EIIS), Dom’air Santé.
s WARNINGS
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).
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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 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.
Target population
The device, which is prescribed by a doctor, is intended to measure the cardio-respiratory parameters of
patients suffering from chronic respiratory 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.
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s 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.
Side effects
Skin irritation, superficial burn and temporary injury may occur.
When not used as intended, a delay in patient care may occur.
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 :
EA photoplethysmography (PPG) sensor, for measuring SpO2 and heart rate
EA 6-axis inertial measuring unit, to count steps, monitor physical activity and measure respiratory rate
EA 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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Figure 1 Hardware overview
Bora band® Model BB-100 presentation
4
1
1
4
6
3
3
7
2
2
1
4
3
6
3
6
3
1
7
Figure 2 Charging the BORA Band
2
5
1
1
4
7
3
5
1
4
3
1. B
1. BORA2.Ban
W
2. Wristband
3. P
3. Push 4.
butto
L
4. LED indica
5. S
5. SpO26.sen
Th
6. Thermal s
2/ First step, plug one end of the micro USB
cable into the USB port of the AC adaptor
1/ Provided accessories
1
2
3
4
plug one end of the micro USB
end
of the
e USB
portmicro
of theUSB
AC adaptor
t of the AC adaptor
Case
Fabric wristband
Button
Indicator light
SpO2 and heart rate
5
Figure 3sensor
Attachwindow
the watch band
Figure 3 Attach the watch band
6 Temperature sensor
7 Micro-USB B Port
Lorsque le bracelet est séparé du boitier, il faut insérer le scratch de part et d’autre du boitier
Lorsque le bracelet est séparé du boitier, il faut insérer le scratch de part et d’autre du boitier
Figure 1 : Bora band ® presentation
3/ Plug the other end of the micro USB cable into the micro
USB AB port of your BORA Band Model BB100 as
illustrated Figure 2
to AC
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4/ Connect to AC
7
Standard Bora band ® kit
Upon delivery, please ensure that the following parts and elements are present. Please contact the carrier
immediately if the package is damaged.
Kit equipment :
E1 Bora band ®, smart bracelet, oximeter and heart and respiratory rate sensor
E1 BB100S fabric bracelet
E1 BB100DC, AC adaptor conforming IEC 60601-1-2
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
BB100DC
BB100UC
BB100S
Description
AC adaptor, IEC 60601-1-2 compliant
Micro USB cable
Fabric wristband
s WARNING
ELECTROMAGNETIC INTERFERENCE
The use of AC adaptor 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.
Bora band® identification
The serial number is listed on the base of your device as indicated in Figure 2.
Model
Serial Number
Figure 2 : Bora band ® identification number
The Unique Device Identifier appears on the plastic carring case labelling, as a 2D datamatrix code and a
symbol.
readable alphanumerique sequence, after the
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Pairing Bora band ® with the mobile application
The data’s transmission stored in Bora band ® is done through a mobile application. This operation requires
the installation of the mobile application on a phone or a tablet and the pairing of Bora band ® with it.
The installation and pairing procedure varies depending on the mobile application used :
- The Bora connect for home application
- The Bora connect ® application
- Partner mobile application
Bora connect for home
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 beforehand by Biosency.
Bora connect ®
Installation of the application
The user should install the application on their mobile phone (the use of the Samsung Galaxy A20e phone
is recommended) or on a tablet. The app is available on the Google Play Store. Type Bora connect ® in the
store search bar. Make sure that the application found is indeed published by BIOSENCY. Follow the store
instructions to install the app.
In order to ensure the application works correctly, the mobile phone on which Bora connect ® is installed must
have the following minimum technical characteristics :
E1,4 GHz processor
ERAM : 2GB
EResolution : 360 x 640 pixels
EBluetooth ® : 4.2 (BLE)
EOperating system : Android version N-5 ou iOS version N-3 where N is the last version
EAccess to a WiFi network or a cellular network with mobile data (3G/4G/5G)
Pairing of the Bora band ®
Bora band ® must then be paired with this phone or tablet. To do this, the first time you use the application,
you will be asked to associate a Bora band ® : fill in the serial number which is under Bora band ® as shown
in Figure 2 : Bora band ® Identification number.
Figure 3 : Pair a Bora band ®
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1
4
3. Push button
7
4. LED indicato
5. SpO2 senso
In order for data transfer to take
5 place, make sure that Bora band ® is in the same room and close to6.(less
Thermal sen
3
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 ® is connected. This mobile application allows you to consult your physiological data.
1
1. BORA Band™ Model BB100 case
2. Wristband
4 refer to the
1 installation and use of the application,
For more information on the
Bora connect ® user manual.
3. Push button
3
7
4. LED indicator
5. SpO2 sensor Port
5
6. Thermal sensor Port
Partner mobile application
Bora band ® can be paired with mobile applications designed by partners. Please refer to the instruction for
use of these applications for a safe combination with Bora band ®.
Figure 3 Attach the watch band
Lorsque le bracelet est séparé du boitier, il faut insérer le scratch de part et d’autre du boitier
Wearing the Bora band®
Fastening
the
BB100S
fabric
Figure
3 Attach
the watch
band wristband
Figure 4 shows how to attach the wristband to the Bora band ® case.
Lorsque le bracelet est séparé du boitier, il faut insérer le scratch de part et d’autre du boitier
Figure 4 : Fastening the fabric wristband
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ue du dessous
Número de série
Modelo
Figure 4 Adjust
the wristband length
Fabric wristband
adjustment
Adjust the size of the wristband as illustrated in Figure 5 below.
2/ Resserrer les deux scratchs
EUndoEnfiler
the fabriclestrap’s
Velcro fastening and adjust to the size of your wrist, then simply secure back
bracelet
in place.
ETo ensure optimal comfort and reading accuracy, make sure the Bora band ® fits snugly on your wrist
3
3
(neither too tight nor too loose).
Figure 4 Adjust the wristband length
e wristband length
2
2/ Resserrer les deux scratchs pour que le bracelet soit ni trop serré ni trop lâche
Enfiler
le bracelet
2/
Resserrer
les deux scratchs pour que le bracelet soit ni trop serré ni trop lâche
et
3
2
2
1
1
1
4
4
Figure
5 : Adjusting
the length of the fabric wristband
Figure 5 Wearing
the BORA
Band
Positioning the Bora band®
ng the BORA Band
Vue du dessous
Vue du dessus
dessous
The Bora band ® Vue
isduworn
on the back of the forearm, slightly below the wrist bone, as illustrated below in
Figure
5
Wearing
the comfort
BORAand
Band
Figure 6. This placement ensures optimal
reading accuracy.
The Bora band ® can be worn on the left or right wrist.
Número de série
Modelo
Vue du dessous
Vue du dessus
Figure 6 - Taking off the BORA Band
1 cm
2
ng off the BORA Band
2
3
3
4
1
Figure 6 : Wearing the Bora band ®
Figure 6 - Taking off the BORA Band
4
2
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Mod
s 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 tatoo and excess hair
can cause inaccurate readings.
PRESENCE OF BRUISING ON THE WRIST
Should bruising appear where the device has been placed, move to the other wrist.
s PRECAUTIONS
FACTORS THAT MAY NEGATIVELY EFFECT PULSE OXIMETER READINGS :
INCORRECT PLACEMENT OF STRAP
Ensure the device is placed 1 cm from the wrist bone.
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Modelo
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).
ORA Band
Figure 6 - Taking off the BORA Band
Figure 6 - Taking off the BORA Band
2
2
2
3
3
4
1
1
3
4
Figure 7 : 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
$
Press button (3)
Off
What it means
$
Fixed GREEN (4)
light for 5 seconds
Off
Bora band®
has started.
4 Indicator light
3 Button
Figure 8 : 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.
Please note that if the battery charge is less than 10%, Bora band ® does not start.
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Número
s WARNING
TROUBLESHOOTING
If the device does not perform as expected, refer to the Repair section or discontinue use and contact
a sales representative.
s 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 ® 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)
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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).
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).
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June 2023
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.
15
2/ First step, plug one end of the micro USB
cable into the USB port of the AC adaptor
1/ Provided accessories
F
Figure 2 Charging the BORA Band
Device
charging
To charge the device, proceed as explained in the figure below.
Figure
2 Charging
the BORA
Figure
2 Charging
the1/BORA
Band Band
Provided
accessories
1/ Take the items
out
of the
packaging
1/ Provided
accessories
1/ Provided
accessories
2/ First step, plug one end of the micro USB
cable into the USB port of the AC adaptor
Figure 3 Figure
Attach
one
of
micro-USB
2/ 2/
First Connect
step,2/plug
end
of the
micro
USB
Firstone
step,
plug
oneend
end of
the the
micro USB
cable
into
the
USB
port
of
the
AC
adaptor
the power
USB port of adapter
the AC adaptor
cablecable
tointo
the
3/ Plug the other end of the micro USB cable into the micro
USB
port of
BORA
Band
BB100
as the micro
3/AB
Connect
the
other
end
of
the
mi3/ your
Plug
the
other end
of theModel
micro
USB
cable into
3/USB
Plug2AB
the other
of the
microBand
USB
cable
the micro
port
ofend
your
BORA
ModelintoBB100
as
illustrated
Figure
cro-USB
cable
to
the
Bora
band’s
®
3/ Plug the other end of the micro USB cable into the micro
USB AB port of your BORA Band Model BB100 as
4/ Connect to AC
4/ Connect
AC power supply
4/ Connect
to tothe
4/ Connect to AC
4/ Connect to AC
illustrated AB
Figure 2
USB port
illustratedUSB
Figure 2port of your BORA Band Model BB100 as
illustrated Figure 2
Figure 9 : Battery charging
What you will see
What it means
What you should do
The device is charging.
Leave the device connected
to the power supply
The device is fully charged.
Disconnect from
the power supply
Flashing WHITE indicator light
Indicator light off
Charging the Bora band ® takes approximately 2 hours.
The autonomy of the Bora band ® battery is more than 3 days.
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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.
s WARNINGS
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.
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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.
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
Fixed BLUE light
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June 2023
What it means
What you should do
The device is installing
Do not turn off the
Bora band ®.
a software update.
18
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 ® platform for health professionals.
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.
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 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 case 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.
BB100S fabric wristband
The BB100S fabric wristband is for single patient use. It therefore should be changed between patients.
s WARNINGS
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.
s PRECAUTIONS
STERILISATION
Do not sterilise using autoclaves, irradiation, gas, ethylene oxide or any other method. This could
seriously damage the device.
Storage
Store the device according to the specified environmental conditions. See the “Environmental conditions”
section for more information.
s PRECAUTION
STORAGE
The battery is designed to be stored for less than 6 months. Beyond 6 months, the battery should
be charged fully.
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Repair
Bora band® default status
What you will see
What it means
The memory is full
OR
Fixed RED light
Indicator light goes
out when I press
the button.
A serious fault has
occurred.
A fault may have
occurred.
What you should do
1. Make sure that your
latest data has been
transferred.
If the fault persists
If the indicator light does not go
out, proceed to the next step.
2. Turn off the device, and
Contact your sales representative.
then switch back on.
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).
VERSION 6.0
June 2023
21
Guarantee exclusions
The Bora band ®, Model BB100, is a precision electronic instrument which should only be repaired by authorised personnel. 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.
The guarantee does not cover indirect damages of any kind.
Guarantee disclaimer/exclusivity
The guarantees set forth in this manual are exclusive and no other guarantee, whether statutory, written, oral
or implied, shall apply.
Incidents
Any serious incident which occurs in connection with the Bora care ® solution should be reported to the manufacturer and to the competent authority of the Member State where the patient resides.
s WARNINGS
GUARANTEE
Opening the case may damage the device and void the guarantee.
MODIFICATIONS / REPAIRS / GUARANTEE
No modification of the device is permitted, otherwise its performance may be compromised. This
device is a precision electronic instrument and should only be repaired by a qualified service technician. On-site repair of the device is not possible. Never attempt to open the case or repair the
electronics. Opening the case may damage the device and void the guarantee.
s PRECAUTIONS
CALIBRATION
The advanced circuit design requires no calibration or maintenance. A functional test cannot be
used to assess the accuracy of the Bora band ®.
Disposal
s PRECAUTIONS
RECYCLING
When disposing of or recycling fabric wristbands, please follow local, regional, and national guidelines as well as any current recycling instructions in force.
WEEE DIRECTIVE
In accordance with European directive 2002/96 / EC on Waste Electrical and Electronic Equipment
(WEEE), please do not throw this product into unsorted household waste. This device contains
WEEE materials; please contact the distributor to return or recycle it.
VERSION 6.0
June 2023
22
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
s WARNING
IT RISK
As the Bora band ® bracelet relies on Bluetooth technology, it is inherently exposed to denial-of-service (DoS) attacks that may prevent it from operating normally. This does not affect the security of
your data but may prevent its proper transmission.
In the event of any suspicion, immediately alert a sales representative.
s RECOMMENDATIONS
INTERNET CONNECTION
With the Bora care ® solution, use an Internet connection secured by a minimum WPA2-type
encryption protocol. This will ensure the security and confidentiality of your data.
YOUR PHONE'S OPERATING SYSTEM VERSION
Make sure you always have the latest version of the operating system (OS) installed on your phone
before using the Bora care ® solution. Having the latest version of the OS is very important, particularly because it allows you to take advantage of the latest security patches for your smartphone.
THEFT / DAMAGE
Do not leave the Bora band ® device unattended. A malicious third party could compromise the
integrity, security and/or confidentiality of your data by physically accessing the bracelet casing.
UPDATES
In order to allow the bracelet to update automatically, regularly connect the Bora band ® device to
the associated telephone.
In addition, in order to prevent IT risks, it is recommended to update the Bora connect ® application
as soon as a new version is available.
PLATEFORM IDENTIFIERS
Please store your login information (username and password) securely and also remember to secure
access to your smartphone with a pin code or biometric recognition. This will prevent an unauthorised
and/or malicious third party from accessing your data. Your connection information is strictly personal
and must not be transmitted to a third party.
USE OF EQUIPMENT
The use of the Bora band ® device is for personal use. In order to avoid misuse, it is recommended
not to allow the device to be manipulated by third parties.
VERSION 6.0
June 2023
23
Technical information
Specifications
Performance at rest
Oxygen saturation accuracy
Heart rate accuracy
Respiratory rate accuracy
Skin temperature accuracy
± 3% (from 70% to 100% SpO2)
± 3bpm (from 35 bpm to 240 bpm)
± 3cpm (from 10 cpm to 50 cpm)
± 0,2°C (from 25°C to 43°C)
Measurement wavelength and output power
Red.................................................................... 660nm to 0.35mW/cm2 maximum average
Infrared.............................................................. 940nm to 1.37mW/cm2 maximum average
Green................................................................. 530nm to 1.6mW/cm2 maximum average
Reading accuracy :
SpO2 and heart rate accuracy tests are performed in induced hypoxia studies with fair to dark skinned, nonsmoking, healthy subjects of both sexes, aged 18 years and over. The arterial haemoglobin saturation (SpO2)
value measured by the device is compared to the arterial haemoglobin oxygen (SaO2) value determined from
blood samples analysed with a CO-oximeter in a laboratory. The heart rate value measured by the device is
compared to the value determined by an electrocardiogram (ECG) carried out in a laboratory. The accuracy
of the device is measured by comparison with CO-oximeter samples measured over the SpO2 range (70 to
100%) and the measured ECG samples.
Respiratory rate accuracy tests are performed in non-smoking, healthy subjects of both sexes, aged 18
years and over. Respiration rate accuracy tests are performed over a range of 5 to 50 cycles per minute. The
respiratory rate value measured by the device is compared to the value determined by a device used for monitoring end-expired carbon dioxide. Device accuracy is compared to samples from the end-expired carbon
dioxide monitoring device which is measured over a respiratory rate range (5 to 50 cpm).
In accordance with ISO 80601-2-61, (medical electrical devices - particular requirements for basic safety and
essential performance of pulse oximeter equipment), precision data is calculated using the root mean square
value (Arms value) for all subjects. Device measurements are statistically distributed. The precision indicated
is the average root mean square error (ARMS). Two thirds of measurements made by the device will have an
error less than the average root mean square error (ARMS).
The Bland and Altman plot (i.e., (SpO2- SaO2) versus SaO2) are available at biosency.com/clinique/#Vc.
VERSION 6.0
June 2023
24
Equipment response time
Equipment delay
Delay time
Display time delay on
Bora connect ®
The data measured by the Bora band ® Model BB100 is time stamped
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 ®.
System
Interface connectivity
Memory
BLUETOOTH ® 4,2 / 5.0
Type
Non-volatile
Capacity
Up to 20 days
Electrical information
Power supply
Battery charging port
DC 5V input, 210mAh, Rechargeable Lithium-Ion battery.
Micro-USB B type
Charging time
Power consumption
2 hours
Battery life greater than 3 days, with regular control checks carried out
(1m30s) every 10 minutes.
Physical characteristics
Case dimensions
(length x width x height)
Weight
Case
42mm x 40,2mm x 13,7mm
19,8 gr
Case and wristband
Materials
25,1 gr
Case
Polycarbonate/ABS – SEBS
Wristband
Case IP rating
Polyamide
IP64
Protected from total dust ingress.
Lifespan
VERSION 6.0
June 2023
Water sprayed from any direction should not have a harmful effect.
3 years
25
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.
Time required (after storage) for the device to be operational : 15 minutes to rise from a temperature of -20°C to + 10°C ; 5 minutes to drop
from 40°C to 38°C.
Storage / transport conditions
Temperature : -20°C to +35°C
Shelf life : 20 months
(up to 5 years with a battery charge every 6 months
Relative humidity : 20 % à 95 %, without condensation.
s PRECAUTIONS
Please respect the environmental operating conditions, in particular the temperature. Should the
device be exposed to environmental conditions other than those specified in the “Environmental
Conditions” section, patients should wait 15 minutes before wearing it.
Conformity
Biocompatibility
ISO 10993-1
ISO 10993-5
ISO 10993-10
IEC 60601-1-2
EMC
IEC 60601-1-11
ETSI EN 301 489-1
Electrical safety
ETSI EN 301 489-17
IEC 60601-1
IEC 60601-1-6
IEC 60601-1-11
ISO 80601-2-61
IEC 60529-1
ETSI EN 300 328
RF
EN 62479
IEC 60601-1 classification
Type of protection
Internally powered (Battery)
Degree of protection
Operating mode
BF type applied part
VERSION 6.0
June 2023
Continuous
26
Wireless transmission
Bluetooth conformity
Operating frequency
Output power
Operating range
Network topology
Operation
Antenna type
Modulation technique
Bandwidth
BLUETOOTH® LOW ENERGY 4.2
2,4 to 2,483 GHz
<10dBm
10 m range indoors
Point to point
Slave
Internal
Frequency shift modulation
Frequency-hopping spread spectrum modulation
1 MHz, 2MHz
Operating principles
Pulse oximetry is a non-invasive method that diffuses light (red and infrared) through irrigating tissues and
detects signal fluctuations due to arterial blood pulses. Well-oxygenated blood is bright red, while poorly
oxygenated blood is dark red. The pulse oximeter determines the functional oxygen saturation of arterial
haemoglobin (SpO2) from this colour difference. As blood volume fluctuates with each heartbeat, the ratio of
absorbed red and infrared light is measured.
Clinical benefits
Improving the quality of life is a clinical benefit of setting up remote monitoring with Bora band ® by increasing
patient reassurance and his acceptation of the rehabilitation training (see table below for more details).
Improving the quality of patient care is a clinical benefit of setting up remote monitoring with Bora band ®. The
clinical parameters measured by the device can be used by practitioners to prevent post-discharge readmission and to detect a wrong oxygenotherapy prescription and generate a new O2 prescription and/or prescribe
another exam (see table below for more details).
Benefits
Quality of Life
improvement
VERSION 6.0
June 2023
Population
Source
Results
Acceptation of the
rehabilitation training
BPCO, OSAS
eMEUSE clinical trial
84% (95% Confidence Interval : [75% - 93%]) of patients
taking a personalized physical
training in pulmonary rehabilitation with Bora care ® solution did not quit the program
Patient reassurance
BPCO, OSAS
eMEUSE clinical trial
95% of patients (95% CI :
[91% - 99%]) were reassured
by the Bora care ® solution.
27
Benefits
Quality of
patient care
improvement
VERSION 6.0
June 2023
Population
Source
BPCO
DACRE clinical trial
Mean patient compliance of
Brinchault, G., et al. "Évo90% (95% CI : [87% - 92%])
lution des signes vitaux
en vie réelle de patients
BPCO: facteurs préventifs
d’une réadmission après
une hospitalisation pour
exacerbation sévère–étude
clinique en vie réelle
DACRE." Revue des Maladies Respiratoires Actualités 15.1 (2023): 70.
BPCO, OSAS
eMEUSE clinical trial
Mean patient compliance of
Le Guillou, Y., et al. "Vital 90% (95% CI : [88% - 91%])
Signs Remote Patient
Monitoring in Real-life for
Early Detection of Acute
Exacerbations of Chronic
Obstructive Pulmonary Disease." C15. EMERGING
COPD DIAGNOSTICS
AND TREATMENTS.
American Thoracic Society, 2023. A4496-A4496.
Chronic
Respiratory
Diseases
APOR clinical study
Mean patient compliance of
90% (95% CI : [82% - 93%])
Prevention of postdischarge readmission
BPCO
DACRE clinical trial
Brinchault, G., et al.
"Évolution des signes
vitaux en vie réelle
de patients BPCO:
facteurs préventifs d’une
réadmission après une
hospitalisation pour
exacerbation sévère–étude
clinique en vie réelle
DACRE." Revue des
Maladies Respiratoires
Actualités 15.1 (2023) : 70
Respiratory rate correlates
with readmission (0,607, p-value=0,010)
Heart rate correlates
with readmission (0,416,
p-value=0,097)
Detection of wrong
oxygenotherapy prescription and generation
of a new O2 prescription and/or prescribe
another exam
Chronic
Respiratory
Diseases
APOR clinical trial
Bora care ® is useful to
confirm the O2 prescription,
or detect a wrong O2 prescription and generate a new
O2 prescription, or prescribe
another exam in 54% of the
cases (95% confidence interval: [25% - 81%])
Patient compliance
Results
28
Manufacturer’s declarations
All the information given below is taken from standard requirements to which manufacturers of electromedical
devices must adhere to in accordance with standard IEC 60601-1-2.
The medical device complies with applicable electromagnetic compatibility standards. However, the user
should ensure that possible electromagnetic interference does not create an additional risk, e.g., radio frequency transmitters or other electronic devices.
In this chapter you will find all the necessary information to ensure the effective installation and commissioning of your medical device in terms of electromagnetic compatibility.
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.
The medical device must not be used near or placed on top of another device. If this cannot be avoided,
please check its correct functioning before use (in accordance with the conditions of use).
The user or installer of the medical device can help prevent electromagnetic interference by maintaining a
minimal separation distance, which will be dependent on the maximum radio frequency power of the transmitting equipment. Do not use any portable RF communications device (including peripherals such as antenna
cables or external antennas) within 30 cm of the Bora band ®, including cables specified by the manufacturer.
Otherwise, the performance of these devices may be impaired.
s WARNING
ELECTROMAGNETIC INTERFERENCE
This equipment complies with the international IEC 60601-1-2 standard relating to the electromagnetic
compatibility of medical electrical equipment and / or systems. This standard is designed to provide
reasonable protection against harmful interference when installed in a typical medical setting. However,
given the proliferation of radiofrequency waves transmitted by equipment and other parasitic sources
in healthcare settings and other environments, it is possible that high levels of interference, caused by
close proximity or power from a source, could negatively impact the operation of the device. Medical
electrical devices require special precautions regarding electromagnetic compatibility, and all devices
must be installed and commissioned in accordance with the information specified in this manual. Portable RF communication devices (including peripherals such as antenna cables and external antennas)
should not be used within 30 cm of the Bora band ®, including cables specified by the manufacturer .
Otherwise, the performance of these devices may be impaired..
VERSION 6.0
June 2023
29
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
(Radiated Emissions) (CISPR 11)
The medical device uses RF energy for its internal functioning. Nearby electronic equipment may be affected.
Interference voltage at the power supply Class B
terminals (Conducted emissions) (CISPR
11)
This device is suitable for use in all establishments, including domestic establishments and those directly connected to public low-voltage systems supplying buildings for
domestic use.
Harmonic current emissions
Compliant
/
Voltage variations, voltage fluctuations Compliant
and flicker (IEC 61000-3-3)
/
(IEC 61000-3-2)
Table 2: Magnetic and electromagnetic immunity
Immunity test
Test level
according to IEC 60601
Level of
conformity
Electromagnetic environment
- notes
This medical device is intended for use in the magnetic and electromagnetic environment described in this
table. The user and installer should therefore ensure that the medical device is used in such an environment.
Electrostatic discharge
(ESD) (IEC 61000-4-2)
± 8 kV contact discharge
± 8 kV contact discharge
± 15 kV air discharge
± 15 kV air discharge
Electrical fast transients in ± 2 kV for power supply lines ± 2 kV for power supply
bursts
± 1 kV for input / output lines lines
(IEC 61000-4-4)
Shock waves
± 1 kV in differential mode
(IEC 61000-4-5)
± 2 kV in common mode
Immunity to nearby
magnetic fields
Not applicable since the product does not contain
elements sensitive to magnetic fields.
Voltage dips, short
interruptions, and voltage
variations
(IEC 61000-4-11)
0% UT for 0.5 cycles
Power Frequency Magnetic Field Immunity
(IEC 61000-4-8)
± 1 kV in differential mode
0% UT for 0.5 cycles
A 0°, 45°, 90°, 135°, 180°, 225°, A 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
270° and 315°
0% UT for 1 cycle
0% UT for 1 cycle
70% UT
70% UT
For 25 cycles at 50 Hz
For 25 cycles at 50 Hz
For 30 cycles at 60 Hz
For 30 cycles at 60 Hz
Single phase :́ at 0 °
Monophase : at 0°
30 A/m
30 A/m
Home health care and
professional health care
facilities.
NOTE: UT is the A.C. mains voltage prior to application of the test level.
VERSION 6.0
June 2023
30
Table 3: Manufacturer’s declarations and notes - electromagnetic immunity
Immunity test
Level of
conformity
IEC test level 60601
Electromagnetic
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.
WARNING : Portable RF communications devices (including peripherals such as antenna cables and external antennas) should not be used within 30 cm (12 inches) of the Bora band ® Model BB100, including cables specified by the
manufacturer. Otherwise, the performance of these devices may be impaired.
Conducted Disturbances,
Induced by RF Fields
(IEC 610004-6)
Radiated, radio-frequency,
electromagnetic field
immunity test
(IEC 61000-4-3)
Proximity fields from RF
wireless communications
equipment
(IEC 61000-4-3)
VERSION 6.0
June 2023
3V
3V
150kHZ to 80MHz
150kHz to 80MHz 80% MA to 1 Z
Home health care
environment.
6 V in ISM band and band 6 V in ISM band and band between
between 0.15 MHz and 80 0.15 MHz and 80 MHz, including
MHz, including amateur ra- amateur radio band
dio band
80% MA to 1 kHz
80% MA à 1 kHz
10 V/m
10 V/m
80 MHz to 2.7 GHz
80 MHz to 2.7 GHz
80% AM at 1kHz
80% AM at 1kHz
9 V/m
9 V/m
710 MHz, 745 MHz,
710 MHz, 745 MHz,
780 MHz, 5240 MHz,
780 MHz, 5240 MHz,
5550 MHz, 5785 MHz
5550 MHz, 5785 MHz
27 V/m
27 V/m
385 MHz
385 MHz
28 V/m
28 V/m
450 MHz, 810 MHz,
450 MHz, 810 MHz,
870 MHz, 930 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz,
1720 MHz, 1845 MHz,
1970 MHz, 2450 MHz
1970 MHz, 2450 MHz
Home health care
environment.
Home health care
and professional
health care.
31
Copyrights and Trademarks
Pulse Oximeter
2797
The BLUETOOTH® brand and logos are registered trademarks of Bluetooth SIG, Inc.
BB100
mps blancs
A changer
Bora band
® and
Bora connect ® are registered trademarks of Biosency in France and Europe.
AxxZZZ
™ Pulse Oximeter
Symbols
2797
Pulse Oximeter
™
Rating : 3.7 VDC
2797
This chapter describes the symbols that are used on the product or its packaging.
CY
Avenue des champs blancs
esson Sévigné
9 73 24 88 10
BB100
A changer
BIOSENCY
BB100
AxxZZZ
1137 A Avenue des champs blancs
A changer
35510 Cesson Sévigné
Please consult
the user guide before using the device.
AxxZZZ
mm/yyyy + 33 (0)9 73 24 88 10
Relative humidity
limitation,
non-condensing
™ Pulse Oximeter
Rating : 3.7 VDC
No Alarms
2797
: 3.7 VDC
Type BF appliedRating
part.
BIOSENCY
™ Pulse Oximeter
1137 A Avenue des champs blancs 2797
35510 Cesson Sévigné
No alarm trigger.
mm/yyyy + 33 (0)9 73 24 88 10
BIOSENCY
BB100
Operating 1137 A
Relative
humidity
No Alarms
Avenue
des champs blancs
Operating
Do not use
temperature
limitation,
temperature
if the packaging
35510non-condensing
Cesson
Sévigné
is damaged
Relative humidity
limitation,
non-condensing
A changer
AxxZZZ
No Alarms
A changer
Non-sterile.
AxxZZZ
mm/yyyy + 33 (0)9 73 24 88 10
Rating : 3.7 VDC
Non-ionising electromagnetic radiation. Includes Radiofrequency (RF) transmitRating : 3.7 VDC
ters. The
equipment contains radio transmitters. Interference may occur in the
vicinity of equipment marked with this symbol.
Operating
temperature
Do not use
if the packaging
is damaged
™ Pulse Oximeter
™ Pulse Oximeter
2797
BIOSENCY
Operating
Do not1137
use A Avenue des champs
blancs
temperature
the packaging
35510 Cesson Sévigné
BB100
e des
champs
blancs
is damaged
m/yyyy + 33 (0)9 73 24 88 10
BB100
RelativeBB100
humidity
limitation,
AxxZZZ
non-condensing
A changer
Relative humidity
limitation,
non-condensing
No Alarms
CE
mark indicating compliance with current medical devices regulations.
2797
Notified body : BSI NL.
No Alarms
Protected
from total dust ingress.
IP 64
A changer
Protected from water spray from any direction.
™ Pulse
AxxZZZ
Oximeter
2797
Sévigné
88 10
Indicates that separate collection for waste electrical and electronic equipment
(WEEE) is required.
Rating : 3.7 VDC
95%
+35°C
20°C
NCY
5%
A Avenue
champs
blancs
Storage desRelative
humidity
limitation,
temperature
non -condensing
Cesson Sévigné
Operating
Relative humidity
o not use
0)9
73 24 88temperature
10
limitation,
packaging
damaged
Medical device.
BB100
Keep Dry
A changer
™ Pulse Oximeter
AxxZZZ
Serial number.
No Alarms
™ Pulse Oximeter2797
™ Pulse Oximeter
2797
non-condensing
2797
Unique device identifier
Rating : 3.7 VDC
BIOSENCY
BB100
CY
1137 A Avenue des champs blancs
Product reference A changer
BIOSENCY
BB100
BB100
35510
Cesson
Sévigné
Avenue des
AxxZZZ
1137champs
A Avenueblancs
des champs blancs
A changer
A changer
mm/yyyy + 33 (0)9 73 24 88 10
esson Sévigné
35510 Cesson Sévigné
AxxZZZ
AxxZZZ
The box should be recycled.
+ 33
9mm/yyyy
73 24 88
10(0)9 73 24 88 10
Rating : 3.7 VDC
BLUETOOTH® logo.
Rating : 3.7 VDC
Rating : 3.7 VDC
Operating
temperature
Operating
temperature
Operating
temperature
Relative humidity
limitation,
non-condensing
No Alarms
Humidity rate limit.
Maximum and minimum humidity (% relative humidity, without condensation).
Relative humidity
limitation,
non-condensing
Relative humidity
limitation,
non-condensing
VERSION 6.0
June 2023
Minimum and maximum temperature (°C).
Operating
temperature
Do not use
if the packaging
is damaged
Do not use
he packaging
is damaged
Required temperature.
No Alarms
Relative humidity
limitation,
non-condensing
No Alarms
No Alarms
32
Pulse Oximeter
CY
Avenue des champs blancs
Cesson Sévigné
9 73 24 88 10
BB100
BIOSENCY
1137 A Avenue des champs blancs
35510 Cesson Sévigné
mm/yyyy + 33 (0)9 73 24 88 10
BB100
A changer
AxxZZZ
A changer
AxxZZZ
Rating : 3.7 VDC
95%
+35°C
-20°C
2797
Store in a dry place.
5%
Storage
temperature
Relative humidity limitation,
non -condensing
Keep Dry
™ use
Do not
if the
packaging is damaged.
Pulse
Oximeter
2797
Operating
Do not use
temperature
if the packaging
is damaged BIOSENCY
Relative humidity
limitation,
non-condensing
No Alarms
Manufacturer
1137 A Avenue
des champs blancsand date of manufacture.
A changer
35510 Cesson Sévigné
AxxZZZ
+
33
(0)9
73
24
88
10
mm/yyyy
BB100
™ Pulse Oximeter
Rating : 3.7 VDC
Manufacturer’s contact details
Do not use
if the packaging
is damaged
Operating
temperature
Relative humidity
limitation,
non-condensing
No Alarms
Biosency
13 rue Claude Chappe - Bat A Oxygène
BIOSENCY
35510
Cesson Sévigné
1137
A Avenue
des champs blancs
France
35510 Cesson Sévigné
[email protected]
BB100
AxxZZZ
mm/yyyy + 33 (0)9 73 24 88 10
95%
+35°C
-20°C
Do not use if the
packaging is damaged
VERSION 6.0
June 2023
Storage
temperature
5%
Relative humidity limitation,
non -condensing
33
This QR code will give you access
to an electronic version of this user manual.
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