VISIOMED Bewell MyOxy User Manual

MyOxy

BW-OX1

BewellConnect - BW-OX1 - User Manual - 072017v21

A

1

3 4

2

B

C

10

s

1

Readings screen / Pantalla de lecturas / Écran d'affichage

2

USB port / Puerto USB /port USB

3

SpO2level / Nivel de SpO2 / Niveau SpO

4

Pulse rate / Pulso / Fréquence du pouls

5

Bluetooth LED / LED de Bluetooth / Voyant LED Bluetooth

6

Signal indicator / Señal indicadora / Indicateur de signal

7

Battery indicator / Indicador de batería / Indicateur de batterie

2

5

6

7

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SYMBOLS EXPLANATIONS / PRECAUCIONES DE SEGURIDAD /LEXIQUE DES SYMBOLES

Caution / Advertencia / Attention

Keep dry / Mantener seco / Garder au sec
Refer to instruction manual. Note on the equipment “Follow instructions for use”. /

Observación sobre el equipo "Seguir las instrucciones de uso". Observación sobre
el equipo "Seguir las instrucciones de uso".Observación sobre el equipo "Seguir las
instrucciones de uso". /

Voir le manuel d’instructions. Avis sur l’équipement “Suivre
les instructions d’utilisation”.
The device, accessories, and the packaging must be disposed of correctly at the
end of usage. Please follow local ordinances and regulations for disposal. / El
dispositivo, los accesorios y el embalaje deben desecharse de manera adecuada
al final de su vida útil. / Por favor, respete las normas y regulaciones locales sobre
la eliminación de residuos. /

Le dispositif, ses accessoires et son emballage doivent
être recyclés de la façon appropriée au terme de leur utilisation. Veuillez respecter les
règlements et règles locaux.
Partie appliquée de type flottante conforme aux exigences de la CEI 60601-1 -

protection contre les chocs électriques / F-type applied part complying with the
specified requirements of this standard to provide a protection against electric
shock

Pulse frequency / Frecuencia de pulso / Fréquence d’impulsion
Hemoglobin saturation in oxygen / Saturación de hemoglobina con oxígeno /

SpO

2

Saturation de l’hémoglobine en oxygène
Pulse rate (BPM = beats per minute) / Pulso (BPM = latidos por minuto) / Fréquence

PRbpm

du pouls (BPM = battements par minute)
No SpO2 alarm / No alarma de SpO2 / Aucune alarme SpO

2

Protection against accidental water spray / Protección contra rociado de agua
accidental / Protection contre les projections accidentelles d’eau

SN

Serial number / Número de serie / Numéro de série
Federal Communications Commission approval / Aprobación de la Federal

Communications Commission / Approuvé par la Commission Fédérale des
Communications

FCC FCC ID: 2AB359322-0B

Electromagnetic energy. Non-ionizing radiation. See EMC data. / Energía
electromagnética. Radiaciones no ionizantes. Ver EMC data. / Champ
Electromagnétique. Rayonnement non ionisant. Voir EMC data.

3

Serial number

SN

SN :

Year

Month

Day

Serial number

EN

BW-OX1

MyOxy

Compliant with part 15 of the FCC rules.

CONTENTS

1. WARNING ...................................................................................................................... 7

2. PRECAUTIONS BEFORE USE ........................................................................................ 7

3. INFORMATION .............................................................................................................. 8

3.1. OXYGEN SATURATION SPO2 ................................................................................ 8

3.2. PULSE ......................................................................................................................... 10

4. FEATURES ..................................................................................................................... 10

5. USING THE OXIMETER ................................................................................................. 10

5.1. DESCRIPTION ............................................................................................................ 10

5.2. RECOMMENDATIONS BEFORE TAKING MEASUREMENTS ................................... 11

5.3. DOWNLOADING THE APPLICATION ....................................................................... 11

5.4. HOW TO TAKE MEASUREMENTS ............................................................................. 11

6. CLEANING AND MAINTENANCE ................................................................................. 11

7. TECHNICAL SPECIFICATIONS ..................................................................................... 12

8. TROUBLESHOOTING .................................................................................................... 13

Find out how to install and use the BewellConnect® application by visiting our website

www.bewell-connect.us/bewellconnect-app

The manufacturer reserves the right to modify the technical characteristics of the product

without prior notice.

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Dear Customer,
You have just purchased MyOxy, the digital pulse oximeter from BewellConnect® . In order
to use it optimally and efficiently, we recommend that you read these operating instructions
carefully.

1. WARNING

- Only use this device for the purpose for which it was designed as outlined in this guide.

- This device is adapted for spot-checking in hospitals and hospitals facilities.

- Use this device in a temperature range between 41°F and 104°F / 5°C and 40°C.

- Do not expose this device to extreme temperature conditions (> 158°F / 70°C or < -13°F /

-25°C).

- Do not use this device in over 93% of relative humidity.

- This device must always be kept in a clean and dry place.

- Do not expose the device to sunlight or water.

- Do not expose the device to electric shocks.

- Do not drop the device.

- Follow the maintenance instructions given in this guide.

- Do not try to open the device. In the event of malfunctions, contact your customer service.

- Keep out of reach of children.

- The measurement results are given as a guide. If you have any doubts about your results,
please contact your doctor.

- Stop using the device in the event of an anomaly or malfunction.

- This device is not designed for use by people (including children) with reduced physical,
sensory or mental capacities, or by people lacking experience or knowledge, unless they are
assisted by a person who is responsible for their safety and supervision or who has been given
instructions about using this device.

2. PRECAUTIONS BEFORE USE

- Do not use this device near an Electrosurgical Unit (ESU), since it may function incorrectly as
a result.

- The pulse oximeter must be placed so that the pulse can be recorded correctly and the main
objective is to evaluate the oxygen saturation (SpO
with the readings.

) level. Check that nothing is interfering

2

- Do not use the device in an MRI (Magnetic Resonance Imaging) or CT (Computed Tomography)
environment.

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- Do not use this device in situations requiring the presence of an alarm.

- Do not use the device in hazardous environment.

- This device is not designed to be used while the user is being transported.

- The device must not be used near or on top of another device.

- Do not use while charging.

- Do not insert anything into the device except the USB cable during charging.

Inaccurate readings may result from :

- Nail-polish (colorimetric interference) or artificial nails

- High levels of dysfunctional hemoglobin (carboxyhemoglobin or methemoglobin)

- Intravascular dyes (indocyanine green or methylene blue)

- Bright light. If necessary, protect the sensor positioning area

- Excessive movement of the user

- Defibrillators and interference from high-frequency electrosurgical devices

- Venous pulse

- Placing the sensor on a user with a blood-pressure cuff, an arterial or intravascular catheter

- High blood pressure, severe vasoconstriction, acute anemia or hypothermia

- Heart failure

- Stress

- Poor pulse quality (low perfusion)

- Low level of hemoglobin.

3. INFORMATION

3.1. OXYGEN SATURATION SPO2

Oxygen saturation is the level of oxygen in red blood cells after they pass through the lungs.
Many factors can aect the anity of haemoglobin for oxygen and decrease blood oxygen satu
ration. A digital pulse oximeter is non-invasive and can help to monitor SpO

.

2

-

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ANALYSIS OF RESULTS

Warning : This table does not apply to individuals already suffering from certain illnesses (e.g.
asthma, heart disease, respiratory diseases) or who are at altitudes above 4921 feet / 1500 meters.
If you are already suffering from a disease, always consult your doctor to analyze your results. If
you have any doubts about your results, contact your doctor.

SpO2 (peripheral capillary

oxygen saturation) result as a %

Diagnosis

99 - 95 Normal level

94 - 90 Reduced level (medical visit recommended)

< 90

Reference: World Health Organization (WHO): Pulse Oximetry Training Manual, 2011.

Critical level : consult a doctor immediately or call for

emergency help

FALL IN PERIPHERAL CAPILLARY OXYGEN SATURATION DUE TO ALTITUDE

Please note : The following table gives information about the effects of different altitudes on oxygen
saturation levels as well as their effects on the human body. The following table does not apply to individuals
already suffering from certain illnesses (e.g. asthma, heart disease, respiratory diseases). In people already
suffering from these illnesses, the symptoms (e.g. hypoxia) may already occur at low altitudes.

SpO2

Altitude

(peripheral capillary oxygen

Consequences for the individual

saturation) result as a %

1500 - 2500 m > 90 No mountain sickness (in general)

2500 - 3500 m ~ 90

3500 - 5800 m < 90

5800 - 7500 m < 80

Mountain sickness, adaptation

recommended

High probability of mountain sickness,

adaptation imperative

Severe hypoxia, only a stay for a limited

period of time is possible

7500 - 8500 m < 70 Immediate life-threatening danger

Reference : Hackett PH, Roach RC: High-Altitude Medicine. Dans : Auerbach PS (ed): Wilderness Medicine, 3e édition ; Mosby, St.Louis, MO
1995 ; 1-37.

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3.2. PULSE

Warning: the results below show the average for a person in good health whose measurements

are taken in a calm environment.
An individual may have a higher or lower pulse rate as a result of numerous factors (illness,
regular exercise, medical treatment, etc.).
In the event of irregularities in your results (lower or higher pulse rate than normal), we advise
you to consult your physician.

ASSESSMENT OF RESULTS

Normal pulse rate

result (in beats per

minute)

High pulse rate

result (in beats per

minute)

Low pulse rate

result (in beats per

minute)

Age range

120 - 150 > 150 < 120 Infant

80 - 150 > 150 < 80 Child aged 1 - 5

60 - 120 > 120 < 60 Child aged 5 - 12

60 - 105 > 105 < 60 Adolescent

60 - 80 > 100 < 50 Adult

90 - - Elderly person

Reference: Mistovich, Joseph J., Brent Q. Hafen, and Keith J. Karren. Prehospital emergency care. Prentice-Hall, Inc., 2007

4. FEATURES

The digital pulse oximeter is a portable device designed for occasional monitoring of arterial
oxygen saturation (as a % of SpO
and children, in hospitals, health centers and at home. It should not be used for continuous

) and pulse rate (PR) in beats per minute (bpm) on adults

2

monitoring (it does not include an alarm signalling an abnormal result).

5. USING THE OXIMETER

5.1. DESCRIPTION

See page 2

The Bluetooth LED flashes red when searching for the Bluetooth signal and is fixed red when
the connection is made.
If the screen shows “?”, it means the signal is unstable. You need to take the reading again.

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The battery indicator flashes when the battery is low. The device must be recharged using the
USB cable

5.2. RECOMMENDATIONS BEFORE TAKING MEASUREMENTS

- When using the device for the first time, charge the battery via the USB port. Connect the USB
cable of the device to a computer to charge it. Once the device has been charged, you can
disconnect the USB cable.

- Avoid eating, smoking or exercising for 30 minutes before measuring your oxygen saturation.

- Remain calm for 15 minutes before the measurement.

- Keep still and do not speak during the measurement.

5.3. DOWNLOADING THE APPLICATION

The following information may be updated.

Download the BewellConnect® application to your smartphone or tablet :

- via the App Store or Google Play
Then click on the MyOxy icon to activate the sub-application.
The results are immediately transferred by the application via Bluetooth Low Energy.

5.4. HOW TO TAKE MEASUREMENTS

See figure C page 2

Insert your finger (generally the index finger) into the device. The fingernail must be facing
upwards. The device turns itself on automatically when a finger is inserted. The readings appear
on the device screen. Wait until the value stabilizes. When the result flashes, the data has been
transferred to the application.
Important : the data will only be transferred to the application if the application is open while
the device is being used and Bluetooth Low Energy is activated.
The device switches off automatically after eight seconds.
If it is difficult to obtain a reading, try with the other hand or with another finger on the same hand.

6. CLEANING AND MAINTENANCE

- To clean the silicone inside the oximeter that comes into contact with the finger, use 70°
rubbing alcohol. Apply the alcohol using a soft clean cloth. Also use the rubbing alcohol to
clean the finger being measured, before and after use.

- Do not pour or spray liquid on to the surface of the oximeter. Make sure that liquid does not
come into contact with the device openings. Leave the oximeter to dry before using again.

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- Do not sterilize the device in an autoclave, with ethylene oxide or by immersing it in liquid. The
device must not be sterilized.

7. TECHNICAL SPECIFICATIONS

Product name BewellConnect® MyOxy
Model BW-OX1
Classification Classe II

Applied part type BF

IP22
Display type LED screen
LED Specifications Wavelength: Red = 660 ±3nm - Infrared = 905 ±10nm

Radiant power : Red = 3.2mW - Infrared = 2.4mW
Dimensions 1.3 x 1.3 x 2.4 in / 32 x 32 x 62 mm
Weight 1.41 oz / 40 g
Display and

measuring ranges
Accuracy SpO

SpO2 : Display range : 35 - 99% / Measuring range : 70 - 99%

Pulse: Display and measuring ranges: 30 - 250 bpm

: 70 - 100% : ± 3%

2

Pulse : ± 2 bpm
Resolution SpO

: 1%

2

Pulse : 1 bpm
Normal working

conditions

Temperature : 41°F - 104°F / 5°C - 40°C

Humidity : 15-93%RH
Storage conditions Temperature : -13°F - 158°F / -25°C - 70°C

Humidity : ≤93%RH

Atmospheric pressure : 86-106Kpa
Technology Bluetooth 4.0 Smart Ready
Battery Lithium 280mAh
Autonomy 400 readings
Automatic shut-

8 seconds
down

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Bluetooth

10m
transmission
distance

Frequency 2400 - 2483.5MHz
USB USB port 2.0
Accessories

Pulse oximeter, instruction manual, protective pouch, USB cable
provided

8. TROUBLESHOOTING

If one of the following issues arises when using your MyOxy, consult this trouble-shooting
guide. If the problem continues, please contact our customer service department at

www.support.bewell-connect.com.

ISSUE POSSIBLE CAUSE SOLUTION

Sp02 or PRbpm
do not appear
correctly

Sp02 or PRbpm
are unstable

Your finger must be
correctly inserted.

reading

SpO

2

too small to be
measured.

Your finger may not
be inserted deeply

Change the position of your finger and try again.

Try several times. If you have any doubts about
a problem related to the product, seek medical
attention to obtain an accurate diagnosis.

Change the position of your finger and try again.

enough.

The user’s finger is
trembling or the

Try not to move.

user is moving.

Impossible to
turn on the
device

Battery low Recharge the device with the USB cable

Oximeter is damaged Contact customer service

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The indicator
lights turn off

The device
switches itself off
automatically after
eight seconds

Normal

when a signal is not
detected.
Low battery Recharge the device with the USB cable

Error3 Low battery Recharge the device with the USB cable

Oximeter is damaged Contact customer service

Error7

Low battery Recharge the device with the USB cable

Oximeter is damaged Contact customer service

Bluetooth

No data
transferred
to your
smartphone/
tablet

connection
deactivated

Smartphone or
tablet incompatible

Activate the Bluetooth on your smartphone/tablet

Check that your smartphone or tablet has
Bluetooth 4.0 Smart Ready and that your operating
system is up to date (Android version 4.3 or later
Or iOS version 7.1 or later)

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SP

BW-OX1

MyOxy

BewellConnect - BW-OX1 - User Manual - 072017v2 15

En cumplimiento con las normas europeas y con el apartado 15 de las reglas de la FCC.

CONTENIDO

1. ADVERTENCIA .............................................................................................................. 17

2. PRECAUCIONES ANTES DE UTILIZAR ........................................................................ 17

3. INFORMACIÓN ............................................................................................................. 18

3.1. SATURACIÓN DE OXÍGENO SPO

3.2. PULSO ........................................................................................................................ 20

 .......................................................................... 18

2

4. CARACTERÍSTICAS ....................................................................................................... 21

5. UTILIZACIÓN DEL OXÍMETRO ..................................................................................... 21

5.1. DESCRIPCIÓN ............................................................................................................ 21

5.2. RECOMENDACIONES ANTES DE REALIZAR LAS MEDICIONES ............................ 21

5.3. DESCARGA DE LA APLICACIÓN ............................................................................... 21

5.4. CÓMO REALIZAR LAS MEDICIONES ........................................................................ 21

6. LIMPIEZA Y MANTENIMIENTO ................................................................................... 22

7. ESPECIFICACIONES TÉCNICAS ................................................................................... 22

8. RESOLUCIÓN DE PROBLEMAS .................................................................................... 24

Aprenda a instalar y utilizar la aplicación BewellConnect® visitando nuestro sitio web

www.bewell-connect.us/bewellconnect-app

El fabricante se reserva el derecho de modificar las especificaciones técnicas del producto sin

aviso previo.

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