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  4. FAQ for using c-med° alpha in combination with the Gateway, cosinuss° Health (cloud server), and cosinuss° Health Web

FAQ for using c-med° alpha in combination with the Gateway, cosinuss° Health (cloud server), and cosinuss° Health Web

How does the c-med° alpha in combination with cosinuss° Health Web 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.
The Gateway is a receiver, forwarding the data to cosinuss° Health, a cloud server. One Gateway is able to receive data from several c-med° alpha devices.
cosinuss° Health is the cloud server solution from cosinuss° that stores all data and enables access to it. It is also providing different view possibilities of the gathered data, starting from an overview of all monitored patients, to a daily view of a selected patient to a detailed view of each data point of a selected patient and time interval.
cosinuss° Health Web is the web application for the cloud server which enables access to, and analysis of the acquired data. Interface to HL7 Fire and other server interfaces available.

What data is acquired with the c-med° alpha in combination with °Health Web?

Vital signs data: Body temperature, pulse rate, blood oxygen saturation.
Contextual data: Photoplethysmogram (all colors: red, infrared and green PPG), quality indicator for pulse rate, perfusion index of SpO2 measurement and 3-axis acceleration data of the head .

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 an STK or MTK test in accordance with the MPBV or are they maintenance-free?

The sensors must undergo an MTK test 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.

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 the use of ‘Schülke mikrozid® AF liquid’ as an alcohol-based cleaning agent. Alternatively, any other disinfectant with the following composition can be used: 35% (w/w) 1-propanol, 25% (w/w) ethanol or a disinfectant with maximum 60% alcohol, no fragrances, undiluted application.

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.
If you decide to measure in cycles for a few minutes every defined time period, it can significantly increase the battery life time to up to several days.

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.
If you use the Gateway and send the data to the cosinuss° Health cloud, you have access through your cosinuss° Health account. In there, you can view as well as download all gathered data as well or transfer it automatically via one of the available interfaces.

Is the cosinuss° Health cloud server compatible with the hospital data system?

Yes, the cosinuss° Health system allows integration into any hospital data environment.

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

Yes, this is possible as well.

Do you use the patient's name in the cosinuss° Health platform?

No, everything is pseudonymised with hash ID’s, e.g. a patient’s ID could be V4D9.

How do I assign a c-med° alpha sensor and/or a Gateway to a patient?

You can easily assign or reassign devices to patients inside your cosinuss° Health account.

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

10 meters, defined by the Bluetooth connectivity.

Does the Gateway have a buffer to store data?

Yes, it stores data until it is uploaded to the server.

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.

Can I download the data from the server?

Yes, you can download them directly as csv data files or via Rest API.
You can also transfer the data via the Fire HL7 interface.

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.

Do I have the possibility to get updates for the Gateway?

Yes. In your cosinuss° Health account you will see a ‘New Release’ button close to your Gateways if updates are available.