Instruction manual for cosinuss° Three study

Dear all, thank you for being part of our study with the new cosinuss° Three. This is the instruction manual with all the information you need to conduct the study with our system.

Please find here an instruction video regarding the whole study.

Please unpack the LabGateway and plug it into a power supply. The status LED on the LabGateway will turn on. Then connect the Gateway with the LAN (Ethernet) cable to establish a connection with the internet. Another option is to connect the LabGateway with the WIFI (only applicable for TexasTech). If the internet connection is stable, the status LED will turn from red to green.

The in-ear sensors are delivered with mini USB cables. Please make sure to always charge the devices as well those not needed in the moment. Since they are advertising constantly they lose their battery even when not used. The status LED light of the cosinuss° Three on the bottom is red when charging. The charging time for full battery capacity is approximately one hour. The red light will turn off when the battery is fully charged. Afterwards the sensor can be unplugged. If the LED of the sensor is not blinking blue it means it is in sleeping mode. By double tapping the USB port of the sensor it turns on and is ready to be used.

Please note: Please do not place the sensor on top of the LabGateway during charging, as it may get hot. The status LED light of the °Three on the bottom is red when charging. Charging time for full battery capacity is approx. 1 hour. The red light will turn off when the battery is fully charged. Afterwards the sensor can be unplugged.

Please see here the perfect study setup. Build the proctor's table as shown in the pictures below with all devices, receiver and reference devices needed for this study.
Please note: The right ear of the subject where the sensor is located should always point towards the LabGateway.

Follow this URL to start with the study: https://telecovid.earconnect.de/ and log in with your login details provided by Cosinuss.

Click on 'PEOPLE' tab and 'CREATE NEW' to register a new subject. A pseudonym will be generated for every new participant.

After a person has been created, the devices should be assigned.

Please type the serial number of each device and receiver in the 'ADD DEVICES/ RECEIVERS' section.

To assign the LabGateway you will use please type in the 6-digits serial number provided on the back of the Gateway in the 'ADD DEVICES/ RECEIVERS' section.

Then have a look at the subject's ear canal to estimate which sensor size might fit. Choose one sensor and type in the serial number provided on the sensor in the 'ADD DEVICES/ RECEIVERS' section.

Assign a chest strap to the subject by entering the 4-digit serial number written on the chest strap. Put some disinfection to the sensors of the chest strap to turn it on. Then apply the chest strap to the subject's chest.

Now put the sensor as described below into the subject's ear. Before the study starts you might ask the subject to press the sensor a little bit more inside the ear canal to improve the validity of the measured vital sign data.

Here is an example of how the sensor is inserted correctly inside the ear. The head of the sensor is inside the ear-canal and there should be no light shining out. It is ok to see some light shining through the skin. The earhook is firmly positioned in the ear cup, as seen below.

And here are some negative examples of how the sensor is incorrectly inserted inside the ear. Please make sure that the head of the sensor is inside the ear canal and the big part behind the ear. The LED‘s should not shimmer out of the ear-canal.

When all three devices are assigned to the new subject you can start the quality check. Please tell the subject to keep still and quiet and press the button 'Start Test Rec'. It can take up to one minute for first data points to appear in the devices section.

You will now see a signal quality index at the Cosinuss° Three sensor, it should be at least 50. You can also check the perfusion index which should be in a range of 0,2 - 2.

Please note: if the sensor doesn't show valuable data and you have to change it (see chapter 7. Release the sensor), make sure you always sanitize all used sensors before the next participant is measured.

If you have followed all the steps above and there are no data quality limitations (insufficient perfusion and quality index), you can start with the measurement by clicking on ‘Start protocol’.

If the sensor doesn't show accurate data during the Quality check, then you have to try another size which might fit better.

For this you have to go back to “Assign devices” and press the button “Release sensor”. Now you can assign a new sensor to the subject by entering the new serial number.

Please redo the Quality check as mentioned in chapter 6. If a poor data connection is displayed again, please try the next sensor size.
Please note: if every sensor shows insufficient data, please select the one that was the closest to the perfusion index of 0,2 - 2.

Once you have found the perfect sensor size you can go on with the subject's information. Please fill in all mandatory observations listed on the interface. Additionally, you can collect data about other medical histories of the subject.

When all the required observations are filled in you can click on 'START PROTOCOL'.
Please note: make sure your screen is not too small for the 'study protocol' area. If you don't see the 'OBSERVATION' box you have to zoom out your screen a little.

Please follow the described steps as given in the protocol. It always starts with an 'OBSERVATION' measurement with the reference devices which include the thermometer, the pulse oximeter and the blood pressure cuff.

Then press 'START' in the 'SEDENTARY' section and follow the exact steps of the protocol.

Please note: You can check that the cosinuss° Three is measuring, the blue status LED is flashing in short intervals. In addition the status LED of the LabGateway is flashing green, when the sensor is recording the data. Please check the different status LED's of the Gateway here:

When the subject has finished the last sequence of the study protocol, all sensors and receivers will be released from this person. You can then start with a new subject.

• Hold the sensor by the neck during cleaning, to avoid too much rotational movement.
• With a cotton swab soaked in disinfectant clean the sensor head and the inside of the sensor head.

• Spread disinfectant evenly over the entire sensor with a disposable cloth or a spray bottle.
• Allow the disinfectant to take effect for at least 1 minute.

• Wipe completely dry with a disposable cloth.
• The sensor is now ready for use again.
• Please do the same with the chest strap after every use.

To update the firmware of the sensor, please follow the instructions here.
The update of the LabGateway runs automatically when necessary by plugging it into a power supply and LAN cable. This will be indicated by the status LED in blue flashing light.