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FAQ for using c-med° alpha in combination with cosinuss° Health App

How does the c-med° alpha in combination with cosinuss° Health App work?

The c-med° alpha is an in-ear vital signs sensor that is applied in the outer ear canal of the patient. It continuously acquires several vital signs of the patient and transmits that data via Bluetooth.
Data can be received with a smartphone or tablet using the cosinuss° Health App. The received data is stored on the mobile device and can be exported for further use.

What data is acquired with the c-med° alpha?

Vital signs data: Body temperature, pulse rate, blood oxygen saturation (SpO2).
Contextual data: Photoplethysmogram, quality indicator for pulse rate, perfusion index of SpO2 measurement.

How are the measurements working?

Pulse rate and SpO2 are measured with the pulse oximetry method using additionally to red/infrared also green PPG.
Body temperature is measured with an infrared sensor pointing at the eardrum (direct measurement).
Quality indicators are calculated based on the measured PPG raw data of the tri-color LEDs as well as the acceleration signals.

Do the sensors or the box have to undergo a safety check (STK) or measurement check (MTK) in accordance with the Medical Devices Operator Regulation (MPBV) or are they maintenance-free?

The sensors must undergo a measurement check (MTK) once a year, the charging boxes are maintenance-free.

Is it possible to repair or replace the battery or are the devices disposed of in the event of damage or malfunction?

No repair or battery replacement is possible.
Warranty conditions for the c-med° alpha: 24 months from the date of sale to the end customer or other initial commissioning.

What is the life cycle of a c-med° alpha?

24 months from packaging at the manufacturer, Cosinuss GmbH.

What are valid disinfectants?

Recommended cleaning agents:
Primary recommendation: Schülke mikrozid® AF liquid and wipes;
Alternative: Alcohol-based disinfectant (60 % w/w), no fragrances, undiluted use.

Are there different sizes for the c-med° alpha?

Yes, there are three different sizes of the sensor (in-ear part): S, M & L comparable to head phones.

How can you get the right size?

If you need quick application of the sensor, take size M. In case it doesn’t fit into the ear canal, change to size S.
For studies or longer measurements: In order to find the best size you should conduct test measurements of 3 minutes at rest (no moving, talking, chewing etc). Keep an eye on the quality index which should be above 30 (the higher the better). Also, the perfusion index should be between 0.1 – 2. Change to another size if this is not the stable state.

Is the c-med° alpha reusable?

Yes.

How can I disinfect the c-med° alpha?

For disinfection and cleaning we recommend primarily Schülke mikrozid® AF liquid and wipes; Alternative: Alcohol-based disinfectant (60% w/w), No fragrances, Undiluted application. For step-by-step cleaning and disinfection instruction, see c-med° alpha IFU.

How long is the battery life of the c-med° alpha?

If you measure continuously every second, the battery will last up to 12 hours.

How long do I need to charge the c-med° alpha?

1 hour.

How can I access the measured data?

If you use the c-med° alpha in combination with the °Health App, you can access the data inside the app. You have additionally the possibility to export and share it.

Can I integrate the gathered data with a third-party app?

Yes, this is possible as well.

What is the maximum range of connectivity between the c-med° alpha and the smartphone?

10 meters, defined by the Bluetooth connectivity.

Does it matter if the sensor head of the c-med° alpha is dirty?

Yes, because it may influence the quality of the measurements. Please make sure to always clean the head of the c-med° alpha properly.

Is the c-med° alpha waterproof?

Yes, with IP class 47 it is waterproof up to 30 minutes under water and resistant to the ingress of dust of more than 1 mm.

In what situation can I expect a worse measurement quality?

Measuring quality may decrease generally with movements but especially with movements of the jaw during chewing or talking for example.

What environmental conditions should the c-med° alpha NOT be exposed to during the measurement?

Cold wind, direct sunlight, heavy rain. Please cover the sensor and the ear when using it outdoors.

Do I have the possibility to get updates of the firmware for the c-med° alpha?

Yes, using the cosinuss° LabApp, you are able to update your c-med° alpha if an update is available.