cosinuss° Two and Gateway

Remote vital signs monitoring using the cosinuss° Two and the Gateway.

Model numbers: cosinuss° Two: TS01 Gateway: LG01

This product is manufactured by Cosinuss GmbH Kistlerhofstraße 60, D-81379 Munich https://www.cosinuss.com

• Please read the instructions carefully before the first use. This will help you to use the product correctly.
• Please use the product only at home and follow the enclosed information and warnings.
• If you feel a deterioration in your general condition, such as breathing difficulties or shortness of breath, contact the responsible clinical staff/physician.

For health questions and medical advice, please always consult your doctor. Cosinuss GmbH does not issue any medical recommendations. Cosinuss GmbH is not liable for any abusive or unauthorized use of the product. Cosinuss GmbH is not liable for the loss or misuse of personal data or the product. There are no replaceable parts in the device. Supplied components must not be exchanged. The components must never be exchanged, or the device manipulated without the consent of Cosinuss GmbH.

View the list of signs and symbols used within the Labeling and Packaging context of the cosinuss° Health Platform and its in-ear sensors:

• Signs and Symbols

1x USB charging cable

1x Power supply, 1x Modem Stick

If you use a cosinuss° One in conjunction with a Gateway, this instruction is also applicable.

• Plug the Gateway into a power supply and the red power LED on the Gateway will turn on.
• In addition, the Gateway needs to be connected to the Internet. In total, there are three different options (Wi-Fi, LAN or internet-stick) to connect the gateway to the Internet. The type of internet connection of the Gateway dependents highly on the individual use case.

• In most cases, the gateway is used with the Internet stick. This generally enables an uncomplicated Internet connection and portable use of the system.
• Please be aware that using the internet stick will incur costs for mobile data consumption. This fixed amount has already been communicated to you in advance.

This diagram shows how the Internet stick is connected to the Gateway:

1. Make sure the modem stick is correctly connected with the Gateway.
2. Plug the cable of the power supply into the charging socket of the Gateway.
3. Plug the charging adapter of the power supply into a power outlet socket.

Do not try to remove the SIM stick, as it is fixed on the Gateway device.

1. Plug out the Gateway from the power supply.
2. Plug out the USB cable between the SIM stick and the Gateway.
3. Plug in the LAN cable.
4. Plug in the Gateway to the power supply.

Now, the Gateway will use the LAN connection to connect to the internet.

If a connection is not possible, make sure that your network permits the connection with external devices. In case you need to register the MAC address of the Gateway, you find the MAC address in the cosinuss° Health Platform by going to the tab 'RECEIVERS' and clicking on the serial of the Gateway that you use. In the list of attributes that appears, you will find the value for the MAC address. In a clinical setting, it can occur that a connection with a LAN cable is not possible due to security settings and thus no Internet connection can be established for the Gateway. In these cases, use an Internet connection via an Internet stick or WLAN.

How to connect the gateway to Wi-Fi is described in more detail here.

Our in-ear sensors are already partially charged when delivered and should be equipped with enough battery power for a quick product test. In some cases, the battery of the sensor may be no longer charged and needs to be recharged before use. For prolonged use of the device and to ensure maximum battery performance, the device should be fully charged.

Charging the cosinuss° Two:

1. Plug the charging cable into one of the USB sockets of the Gateway.
2. Plug the other end of the charging cable into the charging socket of the cosinuss° Two sensor.

Please do not place the sensor on top of the Gateway during charging, as it may get hot.

• In the preset mode the cosinuss° Two is always switched on and trying to connect to a Gateway. The status LED blinks blue once every three seconds. If a connection to a Gateway is established, the cosinuss° Two will be instructed by the Gateway when and how long to measure and when to be in battery-saving sleep mode.
• Before use, the sensor should be charged.
• In this default mode, there is no possibility to switch the sensor off.

1. Apply the cosinuss° Two preferably to the users' right ear.
2. Guide the back unit of the sensor behind the ear.
3. Let the sensor sit on top of the auricle with the sensor head facing forward.
4. Twist the sensor head towards the entrance of the ear canal.
5. Gently push the sensor head into the ear canal.
6. Optimize the fitting by adjusting the sensor neck.

The cosinuss° Two can be used in two settings: 1. Automatic Mode 2. Standard Mode

• When the device is delivered, it is already set in automatic mode.
• This mode is used to display the vital signs data on a computer via the web interface of the cosinuss° Health Platform. Here for the Gateway and the cosinuss° Two get paired, and the measured data will be sent to the cosinuss° Health Platform in order to record and display the measured data. This mode is a requirement for the use of the cosinuss° Two in combination with the Gateway.
• In Automatic Mode, the cosinuss° Two is always switched on and trying to connect to a Gateway. The status LED blinks blue once every three seconds. If a connection to a Gateway is established, the cosinuss° Two will be instructed by the Gateway when and how long to measure and when to be in battery-saving sleep mode.

• Bluetooth Behavior: When in Automatic Mode, the cosinuss° Two sends data through custom Bluetooth services. Proprietary commands are used to communicate and send data to the Gateway which on the other hand communicates and transmits data to the cosinuss° Health Platform. Using custom Bluetooth services enables additional functionalities like e.g. the transmission of raw data, acceleration data, and other features.
• On/Off Behavior: As soon as there is enough power to turn on, the device will boot up and begin advertising. To conserve power, advertising will occur periodically every 60 seconds in short intervals of 10 seconds. When the blue LED is blinking rapidly, the Two is advertising and when it's off, it's sleeping. There is no way to power the device off manually, so it will run until the battery is too low for operation.

• In this alternative setting, the cosinuss° Two can be paired with a smartphone via Bluetooth.
• Through the cosinuss° LabApp, vital signs data can be displayed on your smartphone.
• Further information about the Standard Setting is available here.

How to switch between the different modes is explained in detail here.

In order to record data, you need to add at least one receiving device (the Gateway) and one sensor device (cosinuss° Two). In addition, a user account needs to be assigned to a cosinuss° sensor and the Gateway. If you want to adjust this assignment, please refer to the following bullet points for more information. In some cases, we have already registered all your devices and created the corresponding user accounts. In all cases, however, make sure that users have already been created and that the corresponding devices have also been assigned to them.

• Enter the following URL into your browser: https://health.cosinuss.com/ and log in with your username and password (cosinuss° provides it).

A subject needs to be assigned to a Gateway and a cosinuss° Two sensor. Moreover, a project needs to be connected with a subject. Therefore, please follow the instructions below:

1. Select PEOPLE in the menu bar.
2. Choose the correct project with SWITCH PROJECT and then Click on CREATE NEW to create a new person.
3. After this, an automatically generated pseudonym has been created and assigned to the person.
4. An input field will then open, and person settings can now be entered.

• Active: Activate or deactivate whether data can be recorded for this user.
• Add Devices/Receivers: New sensor devices and Gateways can be added to a pseudonym. Please ensure that prior assignments have been removed. This registration process is described in more detail in the next explanation step.
• Label: This optional labeling feature can be used to add further descriptions to the pseudonym in order to help to distinguish persons from each other, as subjects are only displayed with their newly created pseudonym. This option is disabled by default and would be displayed in this menu when activated. How to enable this feature is explained here.
• Release: To delete the Gateway or sensor device assignment of a pseudonym, select 'RELEASE' in the sensor or Gateway info, which becomes visible when you scroll further down in the person detailed view. Make sure to release a sensor or the Gateway before pairing it with a new user.
• Data Chunk: This feature is also available in the device info and allows for a comprehensive data overview of the just collected data.
• Observations and person events: Information on possible observations or personal events can be entered here if this has been intended or set for their project. Please confirm and save your selection by clicking 'Add' for each of the available options. The data that may be entered can be adjusted in the project settings.
• Create Person Events and create a labeled timestamp when a person is doing specific actions like “Running”, “Sleeping”, etc…. Kindly note that events can be added for this feature, in the edit project page of the person's project. All Person Events can be downloaded with the API.

In some cases, it might be necessary to reallocate sensors and Gateways or change subject information retrospectively. For example, if a different sensor size is needed or a subject is no longer part of a study. For this, select PEOPLE in the menu bar and click on the pseudonym, which is displayed in blue font and also known as the hash ID of the person. Then you enter the person detailed view. Here, more details about one person are listed, and subsequent adjustments can be made. This is the same dialog box that opens automatically after a new person is created, so all the settings described above can also be edited retrospectively. Additional information about this can be found here.

After selecting PEOPLE in the menu bar, the following options appear when you hover over the row of one particular user.

• RELEASE ALL: Release all sensors and Gateways assigned to a pseudonym.
• PDF: Generate a summarizing PDF label for the selected person.
• DATA: View the data calendar view for the selected person.

Further information about these edit settings is provided here.

For more information about the CSV data download, click here.

• The cosinuss° Two and the Gateway needs to be registered before measurements can be generated.
• Usually test devices are pre-registered for you; however, you still need to make sure that both the sensor and the Gateway are assigned to a person. If the registration and the assignment is already completed, you can skip this step. If not, please follow the steps below, as measurements are only possible with registered and assigned sensors and Gateways. In some cases, it might be necessary to reallocate sensors and Gateways retrospectively. For example, if a different sensor size is needed or a subject is no longer part of a study. Further information about these settings can be found here.

Registration of the cosinuss °Two and the Gateway:

1. Select PEOPLE in the menu bar and either register the sensors and Gateways for a newly created or an already existing person.
2. For the registration of both the sensors and Gateways, the six-digit serial number is entered in the field provided. The serial number consists of the last six digits of the UDI, which is located on the white label of the packaging and is printed on most of the cosinuss °Two sensors. Further explanations regarding the labeling definitions can be found here and earlier on this page.
3. If the serial number is entered correctly, the system will automatically recognize the number, delete it in the input field and list it down below as a sensor or a Gateway that has already been registered.
4. Please, make sure that both the cosinuss° Two sensor and the Gateway has been registered.

In order to see the vital signs data inside cosinuss° Health make sure that:

• The registered Gateway is connected with the registered sensor, which is inserted firmly inside the ear canal.
• Only if the sensor is inside your ear, you can start a measurement.
• A pseudonym for a patient needs to be assigned with both sensor and Gateway.
• After this is done, go to DASH in the menu bar and the vital signs data should be visualized shortly after.

The vital signs data is available for each pseudonym (so for each registered person). By default, you see the results of your last three minutes measurement. A detailed explanation of display options and further settings of the data view is available here.

The current standard configuration of the cosinuss° Health Platform is to start measurement of 3 minutes duration every 15 minutes. After the measurement is completed, the respective values shown above are calculated and shown on the Dash. A detailed description of each parameter can be found here and the method behind the Deviation Score calculation here.

! Due to the currently used standard configuration of the cosinuss° Health Platform, it might take a few minutes until values will be visible on the Dash.

• The duration of the measurement can be changed with the “Trigger it” button in the top-right corner of the dash view after a pseudonym has been selected. In the field, you enter the required duration of the next measurement in seconds and click Go. Thereby, a measurement can be started manually with your selected duration.
• When new measurement configurations are applied, the Gateway will start recording with this new configuration. After the recording is finished, the data will be sent to the server. Therefore, it may take a few minutes before data can be observed on the dashboard.

Note: Establishing the connection to start the measurement may take a few minutes. If a problem occurs with your cosinuss° Two, please follow this troubleshooting information first. If this does not solve the problem, please contact cosinuss° customer service. See chapter: Customer service.

Applies to Gateway versions 2.7.x and higher.

If no troubleshooting is successful, the system requires a RESTART. Do this by plugging the Gateway OFF and back ON to the socket. Try to avoid restarts, if the status LED is blinking or pulsating.

• 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.