Nomics Brizzy+ User manual

©nomics s.a. Tous droits réservés MU_Somnolter_NS22_REV 5_FR / 06-2017 1/2
nomics
Sleep & Breathing
Liège Science Park
4, Rue des chasseurs Ardennais
4031 Angleur (Belgium)
User Guide

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Table of contents
GENERAL INFORMATION......................................................................................................................................................................3
Intended Use ..........................................................................................................................3
Certification ...........................................................................................................................4
Overview and functional description ....................................................................................5
Sensor for measurement of mandibular movement ........................................................7
Nasal cannula.....................................................................................................................7
Respiratory motion sensor ................................................................................................7
Pulse oxymeter...................................................................................................................7
Body position sensor .........................................................................................................7
Function of the recorder ....................................................................................................8
Function of the apios software..........................................................................................8
Warnings and safety notices.................................................................................................9
INSTALLING THE SOFTWARE............................................................................................................................................................11
System requirements...........................................................................................................11
Installing the software.........................................................................................................11
OPERATING THE RECORDER.............................................................................................................................................................12
Preparing a recording ..........................................................................................................12
battery...............................................................................................................................12
Calibration ........................................................................................................................12
Equipment check-up ........................................................................................................12
Carrying bag .....................................................................................................................13
Recommandations to be given to the patient.................................................................13
Installing the recorder..........................................................................................................14
Installation of the mandibular lowering sensor ..............................................................14
Installation of the nasal cannula ....................................................................................14
Installation of the oxymetry sensor.................................................................................15
Connections .....................................................................................................................15
Follow-up of a CPP treatment .........................................................................................17
Making a recording..............................................................................................................18
"AUTOMATIC" mode.........................................................................................................18
"Scheduled" mode............................................................................................................18

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Indicator light ...................................................................................................................20
OPERATING THE SOFTWARE.............................................................................................................................................................21
APIOS software start screen...............................................................................................22
Recording visualization .......................................................................................................23
Downloading of a recording ................................................................................................24
Prepare new record..............................................................................................................25
Signals display .....................................................................................................................30
Signals ..............................................................................................................................30
Navigator ..........................................................................................................................32
Individual pane .................................................................................................................33
Zoom Options...................................................................................................................34
Moving..............................................................................................................................34
Keyboard shortcuts .............................................................................................................35
Automatic analysis ..............................................................................................................35
Manual scoring ....................................................................................................................38
Analysis report .....................................................................................................................40
Configuring the software.....................................................................................................40
Customizing the display ......................................................................................................41
printing .................................................................................................................................43
Managing the recordings.....................................................................................................44
Recharging the battery ........................................................................................................44
Setting time of the recorder ................................................................................................45
Calibrating the recorder.......................................................................................................45
MAINTENANCE......................................................................................................................................................................................47
Service..................................................................................................................................47
Cleaning ...............................................................................................................................47
Environnement .....................................................................................................................47
Disposal................................................................................................................................47
TROUBLESHOOTING ..........................................................................................................................................................................48
GUARANTEE .........................................................................................................................................................................................52
TECHNICAL SPECIFICATIONS.......................................................................................................................................................... 53

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GENERAL INFORMATION
INTENDED USE
BRIZZY+ is a portable sleep recorder made for detecting and assisting in diagnosis of sleep
apnea syndrome and for monitoring its treatment.
It is intended for use by health professionals having basic knowledge of sleep disorders, in
particular of sleep breathing disorders.
The system is simple to use. After having received a short training from a qualified member
of staff, the patient can go back home and install the device himself with the help of the
patient leaflet. Thanks to the automatic wake/sleep discrimination feature, there is no need
to set the time at which the recording should begin.
Furthermore, the software that accompanies the device delivers a high-performance
automatic analysis of the recorded data.
Brizzy+ (NS26 model) records the following parameters :
•Mandibular lowering: mandibular activity presents characteristics which permit
the detection of respiratory events during sleep,
•Mandibular movements: derived from the lower mandible signal, band-pass
filtered signal to display the oscillatory component of the signal,
•Airflow: respiration through a cannula connected to an auxiliary flow sensor,
•Snoring (inspiratory and expiratory): vibratory signal from the nasal cannula,
•Respiratory movements: an accelerometer that measures a respiratory movement
comparable to that of a chest or abdominal belt,
•Oxygen saturation (SpO2): given by the oximeter.
•Pulse frequency: given by the oximeter.
•Plethysmographic waveform: given by the oximeter.
•Body position: indication of the patient’s sleeping position
As an option, Brizzy+ allows the connection of an auxiliary sensor other than the flow sensor,
such as a pneumotachograph for therapeutic monitoring by CPP (Continuous Positive
Pressure).
APIOS – the software – allows displaying the recorded signals, to analyse the data, and to
generate a report, and then helps the operator determine:
•wether the patient suffers from sleep disordered breathing,
•wether the treatment delivered to such a patient needs to be adjusted.

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CERTIFICATION
Brizzy+ is manufactured by Nomics. The manufacturer is certified according to European
Medical Device Directive (MDD) 93/42/EEC and is authorized to apply the CE mark to the
product.
Description of symbols:
Warning / Caution
Port for the mandibular movement (JAWAC) sensor
Port for oximetry sensor
Port for auxiliary sensor
Catalogue number
Serial number
Batch number
D
Do not reuse
Contains or presence of phtalates (nasal cannula)
M
Manufacturer
Refer to operating instructions
IP22
Protected against solid foreign objects of 12.5mm Ø and greater.
Protected against water droplets up to 15° of the vertical
CXXXX
Indication of conformity to the requirements of the European Medical
Device Directive 93/42/EEC
Waste electrical and electronic equipment must not be disposed of
with the remainder of un-separated waste
Admissible storage temperature range

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OVERVIEW AND FUNCTIONAL DESCRIPTION
BRIZZY+ consists of a recording device, of sensors as illustrated above, and of the APIOS
analysis software. A USB cable especially designed by Nomics to transfer the recordings
onto a computer, as well as several accessories, completes the set.

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The table hereafter lists the different items composing the system as well as accessories
and replacement parts which are available:
Nomics Ref
Items
NS22
NS26-MUP
Patient leaflet (available on the Nomics website)
√
NS26-MU
User guide (available on the Nomics website)
√
NS126
Brizzy+ recorder
√
NS405
Sensor for measurement of mandibular movement
Distance Sensor calibration Tool
TegadermTM fixation tape bands (pack of 20)
√
NS500
APIOS, visualisation and analyse software
(available on the nomics website)
√
NS921
Special USB cable for data transfer
√
NS920
Nonin Xpod® pulse oximeter module
√
8000SM
Soft SpO2 reusable sensor - Nonin 8000SM
NS962
Flow sensor module for nasal cannula connexion
√
15805-2
Nasal canal, single use, form SleepSense
NS900
Device fastening belt
√
NS924
Carrying case/pouch
√
✓: indicates that the item is provided with the system.

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SENSOR FOR MEASUREMENT OF MANDIBULAR MOVEMENT
The sensor for mandibular movement measurement is a distance
sensor which permits observation of mandibular movements. The
signal given by this sensor is known as Jawac, short for "Jaw Activity".
Observing and analyzing mandibular movements during sleep allows
not only to identify the different sleep disturbances such as mouth
breathing, snoring, apneas (central, obstructive, and mixed) and
hypopneas, but also to detect conditions of upper airway resistance
(UARS).
It is recommended to become acquainted with the characteristics of the
Jawac signal before using the recorder. If need be, contact your distributor
or the manufacturer who will tell you where to find the necessary
documentation.
NASAL CANNULA
Nasal cannulas are used to assess airflow from nasal pressure
measurement. They must be directly connected to the corresponding
protruding endpiece on the flow sensor module, connected on the
auxiliary input of Brizzy+.
RESPIRATORY MOTION SENSOR
Brizzy+ incorporates an accelerometer to measure a respiratory
motion signal comparable to that of a chest or abdominal belt.
PULSE OXYMETER
The Xpod module from Nonin measures the blood oxygen saturation
level (SpO2), the pulse frequency, and the plethysmographic
waveform. Only oximetry sensors from Nonin should be connected to
the module.
BODY POSITION SENSOR
The recorder is equipped with an integrated position sensor. This
sensor measures the patient's position via a 3-axis accelerometer.

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FUNCTION OF THE RECORDER
The device processes and stores the acquired signals in memory.
It is powered by a Lithium Polymer battery.
The battery is rechargeable through USB.
FUNCTION OF THE APIOS SOFTWARE
The APIOS software allows to:
•program the start and end parameters of a record
•pre-record patient information
•download the recorded data onto a computer, and send it by e-mail
•view the signals and start an automatic analysis of the signals
•define the beginning and end points of the analysis
•manually make or change markings
•generate an analysis report and insert conclusions
•set the time on the device
•calibrate the device

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WARNINGS AND SAFETY NOTICES
For your safety and patient safety, please adhere to the following
recommandations :
•Please read this user guide and the corresponding patient leaflet carefully. They are part
of the system and must be available at all times. Please pay particular attention to the
sections marked with a triangle bearing an exclamation mark. Also observe the
directions for use of all the accessories used in conjunction with the device.
•BRIZZY+ is an internally powered equipment. The device is a class IIa equipment
according to the European Medical Device Directive 93/42/EEC.
•The device is intended strictly for assisting in the diagnosis of sleep apnea syndrome
and for monitoring its treatment. It is not intended for life support neither for real-time
apnea monitoring.
•The device is not intended for use on children under three years.
•Do not operate the device in an environment with explosion hazard like in an oxygen-
rich environment or in presence of other flammable agents.
•Do not use the device in an MRI environment.
•The device is not defibrillator proof.
•Do not immerse the device in water or other liquids, or splash it.
•Medical electrical equipment needs special precautions regarding electromagnetic
compatibility (EMC). Information relative to EMC are given at chapter “Technical
Specifications”.
•Portable and mobile RF communications equipment can affect medical electrical
equipment.
•The equipment should not be used adjacent to or stacked with other equipment and, if
adjacent or stacked use is necessary, the equipment should be observed to verify
normal operation in the configuration in which it will be used.
•Avoid using the recorder close to another device emitting strong electromagnetic
interferences.
•It is recommended that you do not use the device on people with pacemakers or similar
medical equipment.
•Only accessories provided by Nomics may be used. Using accessories or equipment
other than those specified may cause malfunction, increased emissions or reduced
immunity to electromagnetic interference and/or damage and will void the warranty.
Please note that Nomics is not responsible for any loss or damage arising from the use
of accessories or equipment that has not been approved.
•Only Nonin branded oximetry sensors must be connected to the Nonin branded Xpod
module (NS920).

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•Do not use any defective equipment. Replace the items that are damaged, worn or
contaminated.
•The device may only be opened by specialized personnel authorized by the
manufacturer, otherwise all warranty rights will be voided.
•The device contains a rechargeable Lithium Polymer battery. Like any other type of
battery, the battery can leak, overheat or cause a fire if its internal components are
damaged. If the device is handled properly, there is no probability of an incident.
Therefore, please, observe the following rules:
▪The battery may not be replaced, except by the manufacturer himself.
▪Do not expose the device to fire or high temperatures over 60°C (140°F). Do not
leave the device inside a vehicle or in direct sunlight.
▪Do not expose the device to water, or to moisture, or operate it with wet hands. Do
not use if liquid has entered the device.
▪Do not subject the device to strong impacts.
▪Do not attempt to use or charge a damaged device; the protective packaging of the
battery could be ruptured or pierced and cause the battery to overheat, ignite,
rupture, or leak.
▪Do not use the device if the battery has leaked. If fluid from the battery makes
contact with your eyes or skin, immediately rinse with plenty of water (at least
during 15 minutes) and contact a doctor. Wash your clothes if they have been
contaminated.
▪Only use the special USB cable provided by Nomics in order to recharge the battery.
Only plug this cable into the USB port of a computer or of a USB charger.
•Sale of the equipment is subject to each country's laws and regulations.
•Nomics declines all responsibility for any loss or damage and all guarantee rights will
be void if the equipment is used in any manner that does not conform to the instructions
given in this user guide.

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INSTALLING THE SOFTWARE
SYSTEM REQUIREMENTS
Minimal configuration requirements:
•Windows® XP SP3, or subsequent
•Graphical resolution min 1024 x 768
•1 USB port
INSTALLING THE SOFTWARE
•Ensure that the computer meets the minimum requirements given above.
•Start the computer. Close every running application before you install the APIOS
software.
•Double-click on the file “APIOS” supplied or download it on the company website.
•You will be informed of all the steps of installation by the installer. Depending on the
configuration of the computer, the installation may take several minutes
•The driver is installed automatically during installation.
•Once the installation is complete, it is recommended to restart the computer.
•Once the computer has restarted, open the APIOS software and close the selection
window that appears:
Go to "Tools" menu, then "Options "and select a "Default root folder".
You can use the search tool to locate a folder or create a new folder. The default root folder
is the one where the records of the unit will be imported.

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OPERATING THE RECORDER
PREPARING A RECORDING
BRIZZY+ is a simple device that the patient can easily install himself/herself. A certain
number of operations are nevertheless required in order to prepare the device before
handing it to the patient. Please read carefully the following instructions and apply them
before each recording.
BATTERY
The device is powered by a Lithium Polymer battery, rechargeable via USB. To recharge the
battery, follow the instructions given at the section "Recharging the Battery".
If the battery is completely charged its autonomy is sufficient to ensure a full night
recording. It has to be recharged after every recording
CALIBRATION
Calibration of the device should be performed if:
•the device is used for the first time,
•the mandibular movement sensor associated with the device is getting replaced.
The calibration automatically adjusts the recorder parameters so that they best fit the
mandibular movement sensor in use. The calibration procedure is described at the
"Calibrating the Recorder" section of this guide. Recalibration of the device can also help if
a problem in acquisition of the Jawac signal arises (see the "Troubleshooting” chapter).
EQUIPMENT CHECK-UP
You should perform the following checks before each use:
•Check all cables and connectors. If a sensor or an accessory is damaged, replace it.
•Make sure that each item has been cleaned/disinfected according to the instructions
given in the corresponding directions for use. Each item must be clean and dry.
•Make sure that the recorder works by making a starting test.

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CARRYING BAG
The carrying case allows the patient to carry the equipment home. It should contain
everything the patient needs to perform a recording.
Check that the special USB cable which serves to connect the recorder to a
computer is NOT included in the carrying case when it is handed to the
patient !
The case should contain the following items (Brizzy+ NS26):
•the patient leaflet,
•the recorder (battery charged),
•the auxiliary flow sensor and a new, unopened, nasal cannula,
•the mandibular movement sensor, with adhesive tape strips (of hypoallergenic type) to
install the probes of the mandibular movement sensor on the forehead and on the chin,
•the Xpod oximetry module, and an oximetry sensor from Nonin,
•the recorder fastening belt.
Additional adhesive tape (of hypoallergenic type) can be added to hold the cables in place.
In addition to the diagnosis assistance of sleep apnea syndrome, Brizzy+ authorizes a study
under Continuous Positive Pressure (CPP) to measure the efficiency of a treatment.
In this case, to record the pressure of the mask, the nasal cannula is replaced by a pressure
tube from the Luer-Lock connector of the flow sensor to the CPAP mask.
A more detailed study under CPP with Brizzy+ is possible by replacing the flow sensor
(Nomics reference NS962) by a pneumotachograph module (Nomics reference NS960). For
more information, Refer to the instruction manual of the pneumotachograph sensor.
RECOMMANDATIONS TO BE GIVEN TO THE PATIENT
To ensure that the recording takes place in the best possible conditions and to avoid
damage or misuse, it is advised to explain to the patient how to operate the device and how
to position the sensors.

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If the device is to be used on a child, make sure that a responsible adult is
clearly shown how to install the cables. Good installation of cables is
important particularly in children to avoid any risk of strangulation. Cables
should not be left loose around the patient’s neck. It is recommended to
tape the cables with adhesive strips or to slip a shirt on over the device and
the sensor cables.
Before the patient carries the device home, give him/her the corresponding patient leaflet
and bring his/her attention to the warnings and notices indicated in the leaflet.
INSTALLING THE RECORDER
The illustration shown at the beginning of this guide gives a general picture of the
installation of the device and the sensors in the case of a diagnosis assistance of sleep
apnea syndrome.
In order to record the correct position, the device must be well maintained and positioned
at the front, at waist level. The front panel of the device must be visible with connectors on
the top.
INSTALLATION OF THE MANDIBULAR LOWERING SENSOR
Placement of the sensor on the patient's face is illustrated in the patient’s leaflet. One is
simply reminded here that it is important that the probes be parallel and on the same vertical
axis. To install the probe on the patient’s face, use adhesive tape of hypoallergenic type in
order to avoid any risk of allergic reaction. For more details, refer to the patient’s leaflet.
The sensor for measurement of mandibular movement is reusable but must be properly
cleaned between each use (see “CLEANING” section hereunder).
INSTALLATION OF THE NASAL CANNULA
Insert the prongs into the nostrils. Loop the tubing around the ears, then under
the chin. Move the cinch tube up under the chin to tighten. The cannula can
also be secured using adhesive tape strips (of hypoallergenic type).
The nasal cannulas are for single use only. They are not intended to be cleaned and reused,
and must be disposed of.

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The opposite symbol “PHT” accompanies the nasal cannulas if they contain
phthalates..
Exposure to phthalates is in most cases not problematic: the doses to which
individuals are exposed are low. As part of the use of Brizzy+, exposure to
phthalates is very low since it occurs via pulmonary inhalation during a
relatively short period of time (a few hours at the most). However, due to the
adverse effect that some phthalates have on reproduction and/or fertility, it
is recommended to use phthalate-free cannulas when the device is installed
on children or on pregnant or nursing women.
INSTALLATION OF THE OXYMETRY SENSOR
Installation of the sensor is illustrated in the documents accompanying the sensor. It is
recommended to run the sensor cable along the arm under the pyjama top. The finger on
which the oximetry sensor is placed must be free of coloured nail varnish.
The 8000J and 8000SM SpO2 sensors from Nonin are reusable. Consult their directions for
use.
CONNECTIONS
Connections
Mandibular lowering sensor plug into the black input symbolized by the
opposite pictogram.
The oxymeter module plug into the white input symbolized by the
opposite pictogram.
The auxiliary flow sensor is connected to the red input symbolized by the
pictogram opposite
Install (screw) the nasal cannula on the tip of the flow sensor intended
for pressure measurement

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Each connector, excepted the one connecting the nasal cannula on the flow sensor, has a
notch, which matches a bump on the corresponding socket on the device. Once notch and
bump are aligned, push the connector in until locked in place.
Always handle accessories with care, by firmly holding the connector between your fingers,
never pull on the wires.

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FOLLOW-UP OF A CPP TREATMENT
For following-up the treatment under CPP, the nasal cannula should be replaced with a tube
of pressure from the Luer-Lock connector of the flow sensor (Nomics reference NS962) to
the CPP mask, as shown in the figure below:
When connecting the pneumotachograph auxiliary sensor for flow rate measurement, refer
to the sensor's operating manual.

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MAKING A RECORDING
The device stores the data in internal memory and keeps it in memory as long as the device
does not get connected to a computer. Once the device gets connected to a computer, the
memory becomes erasable, i.e. the entire memory will be erased at the start of the next
recording in order to free up memory space for the new data to be recorded.
To set aside any risk of data loss, it is recommended to always download
the recording as soon as it has been made.
Two recording modes are available: the "scheduled" mode and the "automatic" mode,
allowing greater flexibility in records management.
"AUTOMATIC" MODE
The default mode is the automatic mode. No programming of the recorder is required in this
mode.
To launch a recording, simply connect the mandibular movement sensor to the device. The
lighting of the LED indicates the correct device startup. Throughout the recording period,
the light flashes.
To stop a recording, simply disconnect the mandibular movement sensor from the device.
The indicator light will stop flashing and the device will return to sleep mode. Data can then
be imported onto a computer via the special USB cable (see chapter "downloading of a
recording”).
"SCHEDULED" MODE
In this mode, the device is programmed to start at a fixed date and time and for a defined
duration. The device will automatically start, the sensors being placed or not. Patient
information can also be stored in the device memory. Programming a recording is done with
the APIOS software (see "Preparing to Record"). At the end of recording, the device turns off
automatically and returns, by default, to automatic mode.