cosinuss c-med alpha User manual

ENGLISH
User Manual
In-ear sensor: MS01
Charging box: MC01
Basic UDI (Sensor): 426046302CMED4F
Basic UDI (App): 426046302CMEDAPP4R
FCC ID: 2ATBZMS01MC01
IC-ID: 25048-MS01MC01
Version: V18
Print date: 2023-12-04
Doc-ID: 1604046965

2Table of conetent
Table of content
Manufacturer information 7
Warnings and precautions 8
Health status � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �10
Usage and application � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �12
Usage on the go� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �17
Bluetooth� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 18
Inuencing factors 20
External inuencing factors � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �22
Internal inuencing factors � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �22
Normal body temperature 23
Normal heart rate 24
Normal oxygen saturation (SpO2) 25
Scope of delivery 29
Product description 30
Intended Use � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 30
Intended patient population� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 31
Performance� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 32
Use and indication� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 32
Contraindication� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �34
Alternative measurement methods 35

3
ENGLISH
Table of conetent
Body temperature � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �35
Pulse rate � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �36
Oxygen saturation (SpO2) � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �36
Application principle 37
Technical principle� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �38
Infrared temperature sensor � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 38
Photoplethysmography (PPG) sensor � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �40
Why inside the ear? � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �43
Application environment� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 45
In-ear sensor� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �49
Signs and symbols 26
Transport and storage environment � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 47
Components 48
Mobile application � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �52
Accessories 55
Charging and safe keeping � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 55
The charging box� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 56
The power supply and charging cable � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �57
Operation 58
Before initial operation � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �58
Initial operation � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �58
Apply the in-ear sensor to the ear � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �61
Monitoring vital signs 63

4Table of conetent
Status bar specication � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 63
Status bar behavior � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 63
Vital sign cards specication� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 65
Vital sign cards behaviour � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �65
Shutdown 69
Charging 70
Health data 71
Cosinuss GmbH� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 71
Data privacy and data security � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 72
Troubleshooting 74
Switching on and off, charging � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �74
Connection and transmission � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �75
Vital signs display � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 76
Wearing comfort � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 77
Care and cleaning 78
Care � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �78
Cleaning � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �79
Product specications 83
General � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �83
Sensor technology� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �87
Vital signs � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �89
Accessories � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �90

5
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Table of conetent
Standards and regulations 94
FCC / ISED according information and statements� � � � � � � � � � � � � � � � � � � � � � � �96
Training and
Supporting Instruction 98
Customer service 99
Unique Device Identication 100
Sensor UDI � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �101
App UDI � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �102
Serial number � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �103
Liability for material defects 103
Statement 105
Disclaimer 106
Where to nd
labeling information? 107

6
WARNING: User Manual
Please read the User Manual before using the device.
WARNING: User Manual
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�
Please read the instructions for use carefully before using the c-med° alpha
monitoring system for the rst time. This makes it easier for you to use the
product correctly. Please keep these instructions for use in a safe place.
Important
NOTE: A note is displayed if additional general information
is available�
WARNUNG: Regulations on the installation, operation and
use of medical devices
The manufacturer recommends to conduct training in accordance
with §4 MPBetreibV (see section Training and Supporting
Instruction)
Important

7
ENGLISH
WARNING: Manufacturer information
The manufacturer information can be found:
• In the User Manual
• In the c-med° app
• On the c-med° alpha charging box
This product is manufactured by Cosinuss GmbH.
COSINUSS GMBH
Kistlerhofstraße 60,
D-81379 Munich, Germany
Telefon: +49 (0)89 740 418 32
Email: [email protected]
Internet: www.cosinuss.com
Patents: DE 102 011 081 815 B4, DE102013222131A1, US10478123B2,
CA2966232A1, CA2875901C, DK2717756T3, ES2728673T3
Designed in Germany.
Manufacturer information
Manufacturer information

8Warnings and precautions
Warnings and precautions
WARNING: Measurement location
Do not use the in-ear sensor on other body parts than the ear!
WARNING: Prohibited usage
Do not use the in-ear sensor:
• If it has any visible damages.
• In cases of any ear diseases or injuries.
• For more than 12 hours without interruption.
• For self-diagnosis of diseases.
WARNING: Ingress protection (IP class 47)
The device is protected against dust, but only for solid foreign
bodies with a diameter of more than 1 mm (class 4).
The sensor is protected against water, but only for temporary
submersion (class 7).
WARNING: Allergic reactions
The casing of the in-ear sensor consists of tested, biocompatible
silicon. No allergic reactions are known. Stop using the device
in case of feeling discomfort and allergic reaction while wearing
the device�

9
ENGLISH
Warnings and precautions
WARNUNG: Arrhythmia and Circulatory Arrest
Since pulse rate measurements are based on an optical detection
of a peripheral pulsatile ow, the measurement is limited in specic
situations:
• Certain arrhythmias may not be detected. Therefore, the pulse
oximeter measurement should not be used as a substitute for
ECG-based arrhythmia analysis.
• During circulatory arrest, a correct measurement of body
temperature, pulse rate and SpO2 may not be possible due to
a sudden stop in effective and normal blood circulation.

10 Warnings and precautions
Health status
• The use of the c-med° alpha monitoring system cannot
replace the consultation with your doctor�
• The System is intended to be used in hospitals, clinics,
long-term care, and home care environments where the
variations of the measured values could not result in
immediate danger to the patient.
• This product is not suitable for self-diagnosis of diseases
by a lay user�
• 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:

11
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Warnings and precautions
• 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
and/or 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.
• 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.

12 Warnings and precautions
• 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 inuence the quality of the ppg
signal and lead to inaccurate readings of SpO2 and heart
rate�
• Neither the in-ear sensor nor the mobile device 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 of approx. 20 °C (68 °F) 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.
Usage and application

13
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Warnings and precautions
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 modications 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
modications 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 0 – 40 °C (32 – 104 °F) for continuous operation
and 0 -50 °C (32 – 122 °F) for transient operation. As the
housing is in contact with the user’s or patient’s skin
during use and the sensor head is in the user’s or patient’s
ear canal, the temperature of the c-med° alpha can be
signicantly higher than the prevailing ambient tempera-
ture�
• Do not store or transport this product under extreme
temperatures (below -25 °C / -13 °F or above 70 °C / 158
°F) or excessive humidity (relative humidity must be
below 95%, non-condensing). This may inuence the

14 Warnings and precautions
accuracy of the IR-thermometer.
• At ambient temperatures of 40 °C (104 °F), self-heating of
1 – 2 °C (1.8 – 3.6 °F) can increase the in-ear sensor
temperature to max. 42 °C (107.6 °F).
• 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 SpO2 results 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,

15
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Warnings and precautions
bathing or swimming as long as there is still water inside
the ear canal�
• Do not use the in-ear sensor under water (bath, shower,
swimming).
• Do not use the in-ear sensor during a magnetic resonance
imaging.
• Do not use the in-ear sensor in places where electrical
equipment is prohibited, e.g. in potentially explosive
atmospheres.
• 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 tting 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 specied 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

16 Warnings and precautions
injury to you or the monitored person, ensure the
compatibility between in-ear sensor, Bluetooth and mobile
devicee including operating system as stated in the
specications before use.
• Do not operate or charge the in-ear sensor directly next to
or on top of other devices. If such a conguration 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.

17
ENGLISH
• 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 and pests.
• Keep the c-med° alpha out of reach from children.
Usage on the go
• The optimal conditions for the device use are an indoor,
wind-protected environment without direct sunlight, such
as in hospitals, clinics, long-term care, and home care
environments where the variations of the measured
values could not result in immediate danger to the patient.
However, the device can also be used outdoors given that
the ambient temperature specications are not exceeded,
and the ear is covered and protected from wind and direct
sun radiation�
• Please be aware of the following when assessing your
health status:
• Special environments can have a fundamental effect on
your vital signs�
• For example, being in an airplane and/or at high altitude
can increase heart rate and decrease blood oxygen levels�
Warnings and precautions

18
• When using the device on the go, be aware of any
impairment of your sense of balance or hearing. Especial-
ly when driving or operating machinery.
• Please note that in an environment where network
communication is not possible, initial connection of the
device may not be possible.
• The use of Bluetooth wireless connections may be
restricted or even prohibited in places such as cars, trains
or airplanes. Please pay attention to the instructions of
the respective providers�
• When traveling to countries with different electronic
requirements (e.g. plug shape, mains voltage), please use
an appropriate adapter to charge the device�
Bluetooth
• The c-med° alpha transmits its data via radio transmis-
sion 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.
Warnings and precautions

19
ENGLISH
• 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.
Such devices may experience interference when a
Bluetooth connection is established nearby�
• cosinuss° is not responsible for any loss of data sent or
received using the Bluetooth function. For example,
through improper interception of the data.
Warnings and precautions

20
Inuencing factors
WARNING: Inuencing factors
Important inuencing factors that can lead to incorrect
vitals signs measurements:
• A dirty sensor head
• A damaged sensor
• Unnecessary movements
• Chewing
• Talking
Important environmental conditions that can lead to incorrect
vitals signs measurements:
• Cold wind
• Direct sunlight
• Heavy rain
Inuencing factors
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