cosinuss c-med alpha User manual

User manual
c-med° alpha*
Version: V08
DOC ID: 1604046957
FCC ID: 2ATBZMS01MC01
IC-ID: 25048-MS01MC01
Typ:
In-ear sensor: MS01
Charging box: MC01
Languages available
Deutsch
English

User manual
c-med° alpha* 0
Languages available 0
Important 4
Warnings and precautions 4
Health status 4
Usage / application 5
Bluetooth 6
Influencing factors 6
External influencing factors 7
Internal influencing factors 7
Normal body temperature 7
Normal heart rate 8
Normal oxygen saturation (SpO2) 8
Manufacturer information 9
Signs and symbols 10
Scope of delivery 11
Product description 12
Intended use 12
Intended operator 12
Essential performance 12
Use and indication 12
Contraindication 13
Application principle 13
Technical principle 14
Infrared temperature sensor 14
Accuracy of body temperature 14
Photoplethysmography (PPG) sensor 14
Accuracy of heart rate 14
Accuracy of SpO2 15
Functional oxygen saturation 15
Why inside the ear? 15
Application environment 16
Transport and storage environment 16
Components 16
In-ear sensor 17
In-ear sensor & LED states 18
Status LED 18
Charging LED 19
Smartphone application 19
Installation of the App 19
Vital signs screen 19
Accessories 21
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Charging and safe keeping 21
The charging box 21
The power supply and charging cable 22
Operation 22
Preconditions 22
Initial operation 23
Turn in-ear sensor on 23
Open the App 23
Identify the in-ear sensor 23
Connect the in-ear sensor 24
Clean the in-ear sensor 24
Apply the in-ear sensor to the ear 24
Leave the in-ear sensor gently hanging
on top of your ear. 24
Monitoring 25
Status bar specification 25
Status bar behaviour 26
Vital sign cards specification 27
Vital sign cards behaviour 27
Check signal quality 28
Quality index 28
Perfusion index 28
Shutdown 29
Close the App 29
Turn in-ear sensor off and storage 29
Charging 29
Health data 30
Cosinuss GmbH 30
Data privacy and data security 30
Troubleshooting 32
Switching on and off, charging 32
Connection and transmission 32
Vital signs display 33
Wearing comfort 33
Care and cleaning 34
Care 34
Cleaning 34
In-ear sensor 34
Charging box 36
Product specifications 37
General 37
Radio data transmission 38
Radio data transmission 38
Power supply 38
2

Rechargeable battery 38
Sensor technology 39
Photoplethysmography (PPG) sensor 39
Thermometer 39
Accelerometer 39
Vital signs 40
Body temperature 40
Heart rate 40
Oxygen saturation (SpO2) 40
Accessories 41
Charging box 41
Power supply 41
Charger cable 42
Smartphone application (App) 42
Standards and directives 42
FCC according information and statements 43
Customer service 44
Unique Device Identification 44
Serial number 44
Where to find the UDI and serial number? 45
Liability for material defects 45
Statement 45
Disclaimer 45
3

Important
● Please read the instructions for use carefully before using the c-med° alpha
monitoring system for the first time. This makes it easier for you to use the product
correctly. Please keep these instructions for use in a safe place.
●Warning: A warning is issued if certain health hazards (i.e. injury, serious
undesirable side effects) or possible damage to the in-ear sensor or accessories are
possible.
●Note: A note is displayed if additional general information is available.
Warnings and precautions
Health status
● The use of the c-med° alpha monitoring system cannot replace the consultation with
your doctor.
● c-med° alpha is intended for use in a home healthcare environment only. This
product is not suitable for diagnosing diseases, but it is a useful tool for monitoring
the temperature, heart rate and the oxygen level. The c-med° alpha is intended only
as an aid in the vital signs assessment of you or the monitored person.
● Please contact your doctor if you notice symptoms such as unexplained irritability,
vomiting, diarrhea, dehydration, changes in appetite or activity levels, seizures,
muscle aches, chills, stiffness of the neck, pain when urinating etc., regardless of the
displayed measured vital signs and regardless of whether or not fever is present.
● Please contact your doctor if the monitored temperature is elevated for more than
two days already.
● Unusually elevated or reduced vital signs may indicate a severe disease, especially
in adults who are older or frail or have a weakened immune system. Please seek
professional advice immediately from the following groups at elevated temperatures:
○ Persons over 60 years of age.
○ Persons with diabetes mellitus or a weakened immune system (e.g. HIV
positive, cancer chemotherapy, chronic steroid treatment, splenectomy).
○ Bedridden patients (e.g. Nursing home patients, stroke, chronic illness,
after surgery).
○ Transplanted patients (e.g. liver, heart, lung, kidney).
● Do not use the c-med° alpha when there are injuries to or in the ear or an increased
sensation of pain in the ear.
● Inspect the in-ear sensor's mounting point at least every 6 to 8 hours to ensure that
the in-ear sensor is properly positioned and the skin is intact.
● The infrared rays of the LED on the sensor head can pose a risk, even if they are not
visible to the human eye. Do not look directly into the LEDs on the sensor head for
long periods of time.
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● Under certain circumstances, it is possible that the in-ear sensor may erroneously
consider a movement as good pulse quality interpreted. Therefore keep movement
during the measurement to a minimum.
Usage / application
● Only use the c-med° alpha in the ear.
● The measurement at rest provides the best results. Avoid unnecessary movements,
chewing and talking during the measurement as they can influence the quality of the
ppg signal and lead to inaccurate readings of SpO2 and heart rate.
● Neither the in-ear sensor nor the smartphone App stores data. All displayed vital
signs data expire automatically after 30 seconds maximum.
● A continuous wearing time of the c-med° alpha of maximum 12 hours and at least 5
minutes per application is recommended.
● If you do not store the sensor at room temperature, allow the sensor to warm up or
cool down for one hour at room temperature (approx. 20 °C) before using the sensor
again.
● Do not use a damaged in-ear sensor. If the c-med° alpha is damaged in any way,
discontinue use immediately and contact the customer service (See chapter:
Customer service).
● The c-med° alpha is an electronic precision instrument. Do not try to repair the in-ear
sensor yourself. Do not try to open the housing or repair electronic components.
Opening the housing may damage the in-ear sensor whereby the liability for material
defects becomes void. Repairs may only be carried out by trained cosinuss°
personnel.
● Don’t make any modifications to the in-ear sensor or any other parts of the scope of
delivery, as these will affect the performance of the c-med° alpha. Changes or
modifications not expressly approved by the party responsible for compliance could
void the user’s authority to operate the equipment.
● This product can be operated at an ambient temperature range of 15 – 40 °C (59 –
104 °F). Do not expose this product to extreme temperatures (below -25 °C / -13 °F
or above 70 °C / 158 °F) or excessive humidity (≥ 90% relative humidity,
non-condensing).
● At ambient temperatures of 40 °C, self-heating of 1 – 2 °C can increase the in-ear
sensor temperature to max. 42 °C.
● When this instrument is operated under the minimum amplitude of 0.2 or above the
maximum amplitude of 1.0 for the Perfusion-index the SpO2results are possibly
inaccurate.
● When this instrument is operated under the minimum amplitude of 30 for the
Quality-index the Heart rate results are possibly inaccurate.
● The c-med° alpha is swallow-proof and contains NO small parts that can be
swallowed or pose a suffocation risk to children.
● Do not operate the in-ear sensor while charging or cleaning.
● Avoid excessive pressure on the in-ear sensor, as the skin under it could be
damaged.
● Applying the in-ear sensor to the left or right ear can affect the signal quality.
● Do not use the in-ear sensor directly after showering, bathing or swimming as long as
there is still water inside the ear canal.
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● Do not use the in-ear sensor under water (bath, shower, swimming).
● To avoid inaccurate monitoring, always clean the c-med° alpha after usage according
to the cleaning instructions in this document (See chapter: Care and cleaning).
● Pay attention to disturbed fitting due to jewelry, glasses or other objects.
● Make sure that your or the monitored person’s ear canal is free of any disturbing
objects.
● If you use accessories other than those specified in the parts and accessories list,
there is a risk of increased electromagnetic emissions and/or reduced immunity of
this equipment.
● To avoid improper performance of the instrument and/or injury to you or the
monitored person, ensure the compatibility between in-ear sensor, Bluetooth,
smartphone including operating system as stated in the specifications before use.
● Do not operate or charge the in-ear sensor directly next to or on top of other devices.
If such a configuration is unavoidable, you need to ensure that normal operation is
not affected.
● For medical electronic devices, special precautions must be taken with regard to
electromagnetic compatibility (EMC). For detailed information on EMC requirements,
please contact your authorized service center.
● Portable and mobile HF communication devices can interfere with medical
electrogenes.
● Do not charge the c-med° alpha with a power near water or other liquids when a
power supply is used.
● As with all medical devices, lay cables and connections carefully, so that you or the
monitored person cannot become entangled in it and possibly be strangled or injured.
● Use only power supplies approved by cosinuss° for in-ear sensor and c-med° alpha
charging box.
● Do not leave the charging cable unattended with small children, there is a danger of
strangulation.
● Keep the c-med° alpha out of reach from pets, pests or children.
Bluetooth
● The c-med° alpha transmits its data via radio transmission using Bluetooth Low
Energy (BLE). Please be aware that data transmission via Bluetooth may involve
security risks. A complete protection of the data against access by third parties is not
possible.
● Communication between in-ear sensor and receiver via Bluetooth Low Energy can
only be guaranteed within a maximum radius of 10 meters.
● If there are obstacles between the devices, like people, buildings, walls or other, the
range may be reduced.
● Please use only trustworthy and properly secured devices to be protected against
unauthorized access.
● The use of the Bluetooth function for non-legal purposes is prohibited: pirate copying,
wiretapping etc. cosinuss° does not accept any responsibility for the consequences
of illegal use of the Bluetooth function.
● Bluetooth Low Energy uses the 2.4 GHz frequency. The same or similar frequencies
are also used by some industrial or medical equipment or low power machines. For
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this reason, these devices may experience interference when a Bluetooth connection
is established near such products.
● cosinuss° is not responsible for any loss of data sent or received using the Bluetooth
function. For example, through improper interception of the data.
Influencing factors
Multiple factors can influence the vitals signs measurement inside the ear:
NOTE:
● Only use the c-med° alpha in the ear.
● The measurement at rest provides the best results. Avoid
unnecessary movements, chewing and talking during the
measurement as they can influence the quality of the ppg signal and
lead to inaccurate readings of SpO2 and heart rate.
External influencing factors
● Direct exposure to wind, sun and water
● Ambient temperature
● Ambient light
● Body Movement in general
● Strong movements of the jaw due to speaking and chewing
● Lying on your ear
● Dirty sensor head
● Damaged sensor head
● Incorrectly attached sensor
● Badly fitting sensor
● Wrong sensor size
● Humidity in the sensor
Internal influencing factors
● Poor blood circulation
● Poor pulse quality
● Poor Perfusion
● Venous pulsations
● Dark skin color
● Anemia or low hemoglobin concentrations
● Sickle cell anaemia
● Cardiogreen and other intravascular dyes
● Carboxyhemoglobin
● Methemoglobin
● Dysfunctional hemoglobin
7

Normal body temperature
The “normal” body temperature is not a fixed number but a temperature range. In a healthy
adult the normal temperature ranges from 36.5 °C – 37.4 °C.1It varies depending on the
location of the measurement, age and external factors. It also varies from person to person
and varies throughout the day. The c-med° alpha is suitable as a continuous monitoring
in-ear sensor for measuring the body temperature.
NOTE:
● When you talk to your doctor, tell him that the temperature you have
monitored with c-med° alpha is a temperature monitored
continuously with an infrared thermometer in the ear.
Normal heart rate
The "normal" heart rate is not a fixed number. In a healthy adult the normal resting heart rate
varies from 60 to 80 beats per minute.2The heart rate depends on various factors: Physical
exertion (e.g. sports activities), weather/temperature, time of the day, medication or illness,
but also mainly on physical condition and age. Gender also plays a role: women often have
a slightly faster pulse than men.
NOTE:
● When you talk to your doctor, tell him that the heart rate you have
monitored with c-med° alpha is a heart rate monitored continuously
by pulse oximetry using a Photoplethysmography (PPG) sensor in
the ear.
Normal oxygen saturation (SpO2)
The oxygen saturation indicates the percentage of oxygen in the blood. In a healthy adult the
normal oxygen saturation is 95 – 99%.3Oxygen saturation can be influenced by various
factors, including air pressure (different altitudes) or certain diseases (e.g. lung and
cardiovascular diseases).
NOTE:
● When you talk to your doctor, tell him that the oxygen saturation you
have monitored with c-med° alpha is an arterial oxygen saturation
(SpO2) monitored continuously by pulse oximetry using a PPG
sensor in the ear.
3Sauerstoffsättigung (sO2), Pschyrembel Online (Abruf: 27.11.20)
2Herzfrequenz (HF), Pschyrembel Online (Abruf: 27.11.20)
1Körpertemperaturmessung, Pschyrembel Online (Abruf: 27.11.20)
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Manufacturer information
This product is manufactured by Cosinuss GmbH.
0123
COSINUSS GMBH
Kistlerhofstraße 60,
D-81379 Munich, Germany
Telefon: [phone]
Email: [email protected]
Internet: www.cosinuss.com
Patents: DE 102 011 081 815 B4, DE102013222131A1, US10478123B2, CA2966232A1,
CA2875901C, DK2717756T3, ES2728673T3
Designed in Germany.
9

Signs and symbols
The following symbols are used in the operating instructions and on the in-ear sensor.
WARNING: Warning and safety information on health hazards (i.e. injury,
serious undesirable side effects, death) or possible damage to the in-ear
sensor or accessories.
NOTE: A note is displayed if additional general information is available.
Not be disposed of with household waste: This product contains
batteries and recyclable electrical waste. To protect the environment, it must
not be disposed of with household waste, but must be taken to the
appropriate local collection points in accordance with the EC
Directive on Electrical Waste. cosinuss° makes an annual contribution to
the environmentally friendly disposal of its products.
0123
CE 0123: The CE marking and the number of the notified body must attest
conformity with the essential requirements Directive 93/42/EEC for medical
devices.
No SpO2Alarm
Question Mark: Vital signs data not valid according to quality index.
Follow the instructions for use.
Product with application parts of type BF (Body Floating).
Product with protection class II.
Manufacturer.
Production batch number.
Model identifier.
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c-med° alpha in-ear sensor.
c-med° alpha charging box.
Universal Serial Bus (USB).
Bluetooth Low Energy (BLE): Radio data transmission by means of
electromagnetic radiation.
FCC: American seal, confirms electromagnetic compatibility.
Direct Current (DC) voltage.
Plug type C: European power plug type for small consumers.
(without earthing contact).
Plug type A: North American power plug type for small consumers
(without earthing contact).
IP 21
Internal Protection 21: Device is protected against dripping water falling at
an angle (up to 15°) and against large solid foreign bodies (diameter ≥ 50
mm).
IP 47
Internal Protection 47: The device is protected against temporary
submersion and against granular solid foreign bodies (diameter ≥ 1 mm).
Scope of delivery
Check the scope of delivery for external intactness of the carton packaging and
completeness of the contents. Before use, make sure that the in-ear sensor and accessories
are free of visible damage and that all packaging material is removed. In case of doubt, do
not use the in-ear sensor and contact your salesperson or our customer service (See
chapter: Customer service).
● c-med° alpha in-ear sensor (MS01)
● c-med° App4(Download)
● c-med° charging box (MC01)
● Power supply (USB charger adapter)
4The c-med° App (smartphone application) is a digital product. It can be downloaded anytime for free
and is available for Android from the Google Play Store and for iOS from the Apple App Store.
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● Charging cable (USB / Micro-USB)
● User manual
Product description
Intended use
The c-med° alpha is intended to be used as a medical measuring device in applications in a
home healthcare environment. The c-med° alpha can continuously measure and visualize
core body temperature, heart rate and blood oxygen saturation of healthy or sick persons
starting at the age of 18.
Intended operator
Intended operator can be every adult person without mental restriction. The medical device
is addressed to non-professional persons, who want to monitor their own or someone else’s
(e.g. partner, family member) health status. The design and the description in the user
manual shall ensure a correct and safe handling.
Essential performance
● Measurement of body temperature in the ear
● Measurement of heart rate in the ear
● Measurement of SpO2in the ear
● Biocompatible materials
● Reliable, accurate and stable output data
● No harm due to radiation
Use and indication
The wearable in-ear sensor enables the continuous measuring of body temperature, heart
rate and SpO2. More specifically, its medical use is to determine these vital signs by a
continuous and non-invasive method in the auditory ear canal. Thereby the captured values
shall be monitored through mobile and wireless methods to provide the user or the
monitored person a more mobile measurement device.
Furthermore, the medical indication of the in-ear sensor is to measure and monitor the vital
signs continuously in cases of fever, respiratory diseases or cardiovascular diseases,
combinations of these diseases or to check the health status of the user or the monitored
person. In contrast to the common medical devices, the user only needs one device (i.e.
in-ear sensor) to get three key parameters. Measurements of all body temperature, heart
rate and SpO2are taken continuously, which makes it easier to classify the user's health
state and the medical condition.
In this context it should be noted that the c-med° alpha monitoring system shall not
recommend any concrete treatments.
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Contraindication
Do not use the in-ear sensor:
● In cases of any ear diseases.
● Outside or under windy conditions.
● In cases of CO intoxication.
● On children younger than 18 years.
● On any other measure site (only in the ear canal).
● In a magnetic resonance tomography room.
● In potentially explosive areas.
Application principle
The in-ear sensor can only be used in combination with its charging box, a mobile device
(smartphone) of the respective user and the installed App. The medical device is intended
for the continuous and non-invasive body temperature, heart rate and SpO2measurement in
the human auditory ear canal.
The measured values of the vital signs are sent via Bluetooth Low Energy to the
smartphone, where the c-med° App displays the values as long as the smartphone is within
the Bluetooth range. The user can see the values as soon as the in-ear sensor is processing
values within the measurement ranges. The Light Emitting Diode (LED) on the back of the
sensor shows the status of the battery and the connection.
The measured vital signs can be seen by the user through the smartphone and the
corresponding c-med° App. Once the App is installed and opened on the smartphone the
in-ear sensor must be taken from the charging box and the Bluetooth service on the
smartphone must be enabled. The in-ear sensor automatically connects to the App.
Application principle of the c-med° alpha.
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Technical principle
Two different sensor types within the c-med° alpha will be used to get the relevant raw data:
An infrared temperature sensor and an optical Photoplethysmography (PPG) sensor,
consisting of two LEDs and one photodiode.
Infrared temperature sensor
A thermal infrared sensor is used to make raw temperature measurements. This sensor
passively measures the heat radiation of the eardrum plus the radiated heat of the
surrounding auditory canal. Due to the so-called thermopile sensor the incident thermal
radiation can be converted into a voltage signal (principle of the thermoelectric effect).
Through calibration and with the help of a proportional to absolute temperature sensor
(PTAT1) element which measures the ambient sensor-temperature it is then possible to
determine the absolute temperature of the measured object or, more specifically, the
eardrum plus the surrounding auditory canal.
Accuracy of body temperature
The body temperature shall be measured with an accuracy of +/- 0.3 °C within the range of
34.0 °C – 43.0 °C.
Photoplethysmography (PPG) sensor
The c-med° alpha measures the oxygen saturation inside the ear by pulse oximetry using a
PPG sensor. Two LEDs, one with red light, one with infrared light, will be used to send light
into the tissue of the ear canal. A photodiode will capture the light coming out of the skin,
convert the light into electrical current. The current will be converted by a trans impedance
amplifier (TIA) into an electrical voltage, which can be easily digitized. The light is modulated
by the blood flow inside the ear canal's tissue. Based on this modulation and the well known
method of pulse oximetry the heart rate and the SpO2can be calculated.
Signal processing principle of SpO2and heart rate.
Accuracy of heart rate
The heart rate shall be measured with an accuracy of +/- 2bpm (beats per minute) within the
range of 50bpm – 180bpm.
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Accuracy of SpO2
The SpO2shall be measured with an accuracy of rms +/- 4% within the range of 70% –
100%.
Functional oxygen saturation
Functional oxygen saturation is the percentage of saturation given by the concentration of
oxyhemoglobin (cO2Hb) divided by the sum of the concentrations of oxyhemoglobin and
deoxyhemoglobin (cHHb).
100 × 𝑐𝑂2𝐻𝑏
𝑐𝑂2𝐻𝑏 + 𝑐𝐻𝐻𝑏
According to the Clinical Laboratory Standards Institute (CLSI), the term for this ratio is
hemoglobin-oxygen saturation, and its designation is SO2.
For SpO2this percentage saturation refers to arterial blood.
NOTE:
● The pulse oximeter equipment is calibrated to display functional
oxygen saturation (SpO2).
● The accuracy of the measurements are influenced by internal and
external factors (See chapter: Warnings and precautions).
● SpO2 measurement accuracy of the c-med° alpha has been
validated using a controlled desaturation study without movement in
healthy volunteers (Men and women, adult age, non-smoking, normal weight,
skin tone according to Fitzpatrick scale) within a range of 70%-100% SpO2
and in reference to a secondary standard pulse oximeter. In this
desaturation study the c-med° alpha achieves an accuracy of
ARMS = 1.85 %. Adding the accuracy of the reference pulse oximeter
(ARMS = 2 %) this sums up to a final ARMS final of 3.85 % which lies
within the 4 % required in the standard DIN EN ISO
80601-2-61:2019.
● Based on statistical distribution, two-thirds of the measurements with
the c-med° alpha can be expected to fall within the overall root mean
square of ARMS=3.85% given above.
● The use of functional test equipment cannot be used to verify the
measurement accuracy.
Why inside the ear?
The ear canal is an ideal place of measurement for vital sign monitoring:
●Blood supply: The ear canal is part of the body core and therefore optimally
supplied with blood. This is essential for all optical measurements on the body and
ensures the possibility for a data collection of high accuracy.
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●Temperature: The body temperature can be measured at various places in and
outside of the body. The core temperature refers to the temperature of the vital
organs. The temperature in the ear correlates with the body core temperature,
because the eardrum (the place where c-med° alpha monitors) and the
hypothalamus (the temperature control center in the brain) have the same blood
supply. Changes in this core temperature therefore affect the ear more quickly than
other parts of the body.
●Skin contact: With the c-med° alpha it is possible to ensure a steady contact of
optical sensing elements and the ear canal tissue which is critical for accurate
measurements with this method anywhere on the body.
●Dark surrounding: The place of measurement is already minimizing the ambient
light that falls into the receiving photodiode. This is essential for reducing noise
artefacts in the received signal and improves the overall signal quality.
●Static movement: The head, and with that also the ear, is by nature protected from
abrupt and fast movements in order to protect the brain. Motion artifacts are thus
minimized due to the placement of the sensor in the outer ear canal.
NOTE:
● Only use the c-med° alpha in the ear.
● The measurement at rest provides the best results. Avoid
unnecessary movements, chewing and talking during the
measurement as they can influence the quality of the ppg signal and
lead to inaccurate readings of SpO2 and heart rate.
Application environment
The c-med° alpha is designed for the use in an indoor, wind protected, home healthcare
environment. Operating conditions:
● Temperature: 15 °C – 40 °C
● Humidity: max. 90 % rH
● Barometric pressure: 700-1060 hPa (700-1060 mbar)
Transport and storage environment
For domestic use, please store the device at room temperature (approx. 20 °C). If this is not
applicable, the in-ear sensor and the charging box shall be stored and transported under the
following general condition thresholds.
● Temperature: -25 °C – 70 °C
● Humidity: max. 90 % rH
Components
The c-med° alpha can only be used in combination with its charging box, a smartphone of
the respective user and the installed App. The medical product is intended for the continuous
and non-invasive body temperature, heart rate and SpO2measurement in the human
auditory ear canal.
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Place of measurement in the external auditory canal.
1
Auricle rim
2
Entrance to the auditory canal
3
Antitragus
4
Earlobe
5
Hypothalamus
6
Middle ear
7
Auricle
8
Outer auditory canal
9
Blood vessels
10
Eardrum
In-ear sensor
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The c-med° alpha in-ear sensor for vital signs monitoring.
1
Sensor neck
2
Red/Infrared LED
3
Contact thermometer
4
Infrared thermometer
5
Photodiode
6
Antitragus curve
7
Pickaxe
8
Status LED
9
Circuit board and battery
10
Charging LED
11
Charging contacts
In-ear sensor & LED states
The LEDs of the c-med° alpha has the following possible states:
Status LED
LED behaviour
Description
Blinking blue
(a short blink every 2.5 seconds)
Advertising.
The in-ear sensor is broadcasting data to available
receiving devices and is ready to establish a
connection.
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Blinking green
(a short blink every 2.5 seconds)
Connected.
The in-ear sensor is working properly.
Blinking red
(a short blink every 2.5 seconds)
Connected.
The in-ear sensor is working properly,
but the battery is low.
Solid red
(only applicable if sensor is
placed in the ear)
Connected.
But the in-ear sensor is probably damaged,
due to improperly working sensors and circuits.
LED is OFF
In-ear sensor is turned OFF.
In-ear sensor is positioned correctly
in the charging box.
Charging LED
LED behaviour
Description
Solid red
In-ear sensor is charging.
LED is OFF
In-ear sensor is fully charged.
Smartphone application
The c-med° smartphone application (App) serves as the display of the c-med° alpha.
The App is displaying:
●Current body temperature value (°C)
●Current heart rate value (bpm)
●Current SpO2value (%)
●Perfusion index
●Quality index
●In-ear sensor battery status
●Bluetooth connection status
Installation of the App
The c-med° App is a digital product. You can download it anytime for free. It is available for
Android from the Google Play Store and for iOS from the Apple App Store.
Vital signs screen
19