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Table of Contents
Summary of Contents for Sense4Care STAT-ON
- Page 1 USER MANUAL (Rev 1.3) March-2019...
- Page 2 User Guide, Rev 1.3. This device has been made under the Council Directive 93/42/EEC, being certified as a Medical Device Class IIa. Sense4Care guarantees that the device has been built under the ISO 9001:2015 for the design, manufacturing and commercialization of industrial electronic controls.
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Page 3: Table Of Contents
Configure your data....................... 7 Place the sensor ......................7 Intended Use ......................... 8 About STAT-ON ........................9 STAT-ON kit components ....................10 The sensor device ......................10 The belt ........................10 The charger system ..................... 11 Patient Use .......................... 12 Location and orientation of the device ............... - Page 4 Standby button ....................23 6.6.8. Delete button ...................... 23 Alarms Area ......................... 24 Send area ........................25 Reports description ......................26 STAT-ON measurements ..................... 26 Extended report ......................28 7.2.1. Summary page ..................... 28 7.2.2. Graphs ......................... 30 Reduced report ......................37 Frequently asked questions (FAQs) ..................
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Page 5: Warnings, Care And Use Instructions
These directives call for separate collection and disposal of electrical and electronic equipment. Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem. Please, return to SENSE4CARE S.L. at the end of its operating life. Contraindications None known. -
Page 6: Quick Start
Upper screen capture: Bluetooth area and Battery indicator Search your STAT-ON device “STATONxx” where xx are the last 2 numbers of the Serial Number (see STAT-ON label at the sensor, S/N). The pin is formed with the last 6 numbers of the Serial Number. -
Page 7: Configure Your Data
Configure your data Please, fill the missing information in order to adjust the algorithms press the ‘save’ button. Then the sensor should stop blinking in white colour, meaning it has been configured. Once the sensor detects movement, its LED blinks in Green colour. Now the sensor is already working. Figure 3. -
Page 8: Intended Use
2. Intended Use STAT-ON is an wearable inertial device, managed by a doctor and worn by the patient. The sensor stores the results of the algorithms that are executed internally and that quantify the severity and distribution of the Parkinson’s Disease patient’s symptoms. -
Page 9: About Stat-On
3. About STAT-ON The STAT-ON system consists of a monitoring device, its base charger, a belt, and a mobile application. The system provides numerical and graphical information of the motor symptoms associated with Parkinson's disease. Furthermore, data related to the general motor activity of the patient are calculated. -
Page 10: Stat-On Kit Components
The STAT-ON is composed by the following components: The sensor device The sensor device (Figure 5), also called STAT-ON, has been developed under the PARK-IT project. The sensor is a 90x12.75x62.5mm device with 83g of weight. It is composed by an ultra- low power high-performance nano-accelerometer, a microcontroller, and a Bluetooth Low Energy system, among others. -
Page 11: The Charger System
Specific belt The charger system The STAT-ON device can be charged wirelessly. It is required to use the wireless charger F8M747 from Belkin as it is compatible with STAT-ON. The base dimensions are 11.6x11.6x1.29mm The AC Charger connected to the base charger must have the following parameters:... -
Page 12: Patient Use
5. Operator Use STAT-ON is a waist-worn inertial device that collects the outcomes of several algorithms that are based on the computation of inertial signal. In other words, it collects data from a triaxial accelerometer, which is embedded within the device. In this section explained, it is the way of using the device. -
Page 13: Sensor Interface And Modes
Sensor interface and modes As shown in the following figure, the sensor device has a button and two led indicators next to the STAT-ON logo. The device also contains a small vibrator motor and a buzzer. Figure 9. Sensor’s interface 5.2.1. -
Page 14: Possible Sensor States
MONITORING LOW_BATTERY Green-magenta SLEEP Always off SLEEP CONNECTED Blue blink SLEEP LOW_BATTERY Magenta blink MEMORY_FULL Red blink MEMORY_FULL CONNECTED Red-blue MEMORY_FULL LOW_BATTERY Red-magenta SYNCHRONIZATION Fast blue blink FORMAT Always blue ERROR Always red Possible sensor states 5.3.1. Connected and low battery indication The sensor will indicate that has an active Bluetooth connection or a low battery level by blinking the led in blue or magenta colour respectively. -
Page 15: Monitoring, Sleep And Standby
It is therefore recommended to synchronize the device data using the STAT-ON App. After the data is sent, the device memory will be automatically cleared and the sensor will be able to monitor again. Formatting (clearing the memory of the sensor) can be also done, but in this case, the stored data not yet synchronized will be completely lost. -
Page 16: Charging The Device
When the sensor connects with the STAT-ON App while in error state, it will transfer the error code to the App and the App will offer to perform a sensor reset. If the error persists after the reset or occurs periodically, please write down the error code displayed on the App and contact support@sense4care.com. -
Page 17: Switching On/Off The System
If the user expects not to use the sensor in a long time, keeping it in shutdown mode is recommended. Shutdown mode is activated after formatting the device using the STAT-ON App (see section 5.3.7- Format). It is recommended to synchronize all the data before formatting in order not to permanently lose all the data stored in the sensor. -
Page 18: Regular Use
Regular use The STAT-ON system is a wearable inertial device that monitors the symptoms of PD patients. This is a medical device and only health professionals must manage it. Outcomes of the sensor might be used to adjust or evaluate a therapy, to adjust the diets of the patient, or evaluate the result of the therapy. -
Page 19: Application Management
Bluetooth Low Energy (BLE) and 1GB RAM minimum. The STAT-ON device also works in iOS for Apple devices. It is required to use iOS 10.2 or higher. The app can be downloaded at Google Play (Android) or the App Store (iOS), search for “STAT- ON”, and make sure its developer is Sense4Care. -
Page 20: Main Screen
After opening the App, it shows the main screen, which enables the access to all the areas and features of the STAT-ON App. It also indicates whether there is an active connection with a sensor and shows its battery level. While on the main screen, the App connects automatically to the paired STAT-ON sensor. -
Page 21: Bluetooth Area
StatOn and then contains the two last digits of its serial number (e.g. “StatOn00”). Press on the STAT-ON device you wish to pair to. A PIN/Passkey request may pop up. If the PIN request does not show up, check the smartphone notifications. Each device has a six-digit numerical PIN/Passkey, which is provided with the sensor packaging. -
Page 22: Configuration Area
The App will notify the user if the synchronization process fails. If the synchronization problems persist, contact Sense4Care for support. Configuration area The values inside the configuration area are stored inside the sensor, thus an active Bluetooth connection is required for its use. Apart from the pin (which is optional), all the parameters from this area must be configured for the sensor to work correctly and exit the “configuration... -
Page 23: Age
6.6.3. Age The Age parameter should be configured before the monitoring starts for the algorithms to work properly. 6.6.4. Hoehn & Yahr value The algorithms require the patient’s stage in the Hoehn & Yahr scale in OFF state. The range of values accepted goes from one to five. -
Page 24: Alarms Area
Alarms Area In the alarms area, the user can configure up to ten alarms each day. The alarms will be stored and will trigger on the STAT-ON sensor, not on the smartphone. The usage of the system alarms is optional. -
Page 25: Send Area
(like e-mail) for transferring the documents. A copy of the generated documents is also stored inside the storage of mobile device, under the <STAT-ON> folder. At the bottom of the screen, the <SEND> button will open a standard ‘share’ dialog, any mailing or file share method can be used. -
Page 26: Reports Description
7. Reports description This section describes the reports generated by the STAT-ON device in order to obtain a correct understanding of the variables provided by the sensor. Through the mobile application two types of reports can be generated that aim to facilitate the task of understanding the data generated by STAT-ON by clinical professionals. - Page 27 1.8 seconds and 3.1 seconds will be reported as episodes of 3.2 seconds. This means that when STAT-ON reports a FoG episode of 1.6 seconds it will last from 0 to 1.6 seconds, whereas when a 3.2 seconds episode is reported it will result in a duration between 1.6 seconds to 3.2 seconds.
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Page 28: Extended Report
[7]. Below, a detailed description of each of the graphs and data generated by the STAT-ON system is presented. Extended report This report presents two separate parts, on the one hand, the “summary page”, where a table is presented as a summary and, on the other hand, a series of graphs that are described in the following sections. - Page 29 User ID: Numeric identifier of the patient, this is a number configurable from the app • that serves to anonymize the patient's data and that only clinical professionals have access to the relationship between the captured data and the identity of the patient. Age: Age of the patient.
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Page 30: Graphs
7.2.2. Graphs 7.2.2.1. Weekly Motor State One of the most relevant graphs in which it shows the motor state of the patient in periods of maximum 7 days. This means that a graph is generated for every 7 days (or less) of monitoring. Below, it is shown an example of the motor state. - Page 31 7.2.2.2. Weekly Time in OFF state This graph shows the daily-accumulated time in OFF state that has been detected. On the horizontal axis, it is shown the days monitored (maximum one week) and on the vertical axis the percentage of monitored time that the patient has been in OFF state. Although the bars are based on the percentage of monitored time that has been detected as OFF state, information is added about the number of hours the patient has been in this state.
- Page 32 Figure 21. Number of FoG episodes 7.2.2.4. Weekly stride fluidity The following graph presents the weekly evolution of the average stride fluidity that the patient presents during the monitoring period. The stride fluidity is a measure of acceleration that is obtained as an intermediate result of the bradykinesia detector, which has a value (ranging from 2 to 25) and which is related to the fluidity of the movement that the patient presents when walking.
- Page 33 7.2.2.5. Weekly physical activity Among the sensor output parameters, there are also data about the physical activity that the patient has performed during the entire monitoring period. The variables shown are: Step length • • Stride speed • Cadence • Energy expenditure Number of steps •...
- Page 34 7.2.2.6. Daily motor symptoms STAT-ON, in the extended report, generates a graph of motor symptoms per monitored day where it can be seen, in addition to the motor status, the dyskinesia and the number of FoG episodes that the patient has suffered as well as the hours of appearance. The resolution in all the daily charts corresponds to half an hour.
- Page 35 background of the graph, the detected motor state is also drawn (red OFF, green ON, yellow INT). Finally, note that the thresholds calculated (as self-adaptive algorithm), upper (green) or lower (red), are also drawn. These thresholds indicate when bradykinesia is considered and, given that patients do not walk in the same way, they are patient-dependent.
- Page 36 Figure 27. Daily energy expenditure and motor states Figure 28. Daily number of steps REV 1.3 – MARCH 2019...
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Page 37: Reduced Report
Reduced report This report is a selection of the extended report that includes all those graphs that are of special interest in order to help the clinical professionals to have a more complete and objective view of the state of their patient: Summary page (7.2.1) •... -
Page 38: Frequently Asked Questions (Faqs)
The sensor needs a minimum of 24 hours of data, which should be captured within three different days (i.e. 8h/day * 3 days approx.). However, it is recommended to wear the sensor, at least, for a week. Contact support@sense4care.com for any other issues. REV 1.3 – MARCH 2019... -
Page 39: Device Labelling
C/ Tirso de M olina 36, Office 18, 08940, Cornellà del L lobregat, B arcelona (Spain) support@sense4care.com eIFU :https://w w w .sense4care.com /support x: stands for the lot number y: stands for the number of device within the lot z: stands for month and year of fabrication (MMYYYY) -
Page 40: Symbols And Labels
10. Symbols and labels Manufacturer Date of manufacture Serial Number Reference number Input power Shock protected, type BF. Consult instructions for use Do not dispose (excluding belt) European Conformity NB0051 REV 1.3 – MARCH 2019... -
Page 41: Privacy
STAT-ON is not capable to share the collected data to a third party without the user consent. Sense4Care S.L. will only access to data under the expressly consent of the user and the owner of the STAT-ON device. Shared data to Sense4Care S.L. will be always pseudonymised, in any case. Pseudonymised data that the user provides us will be incorporated into a file of our responsibility and will be kept under the strictest measures of security and confidentiality. -
Page 42: Technical Specifications
12. Technical specifications Communications Bluetooth specification Bluetooth 4.0 (Bluetooth Low Energy) Bluetooth bandwidth 2,4 GHz Wireless charging standard WPC v1.1 Qi Industry Standard Wireless charging bandwidth 100-205 kHz Electrical features Power Supply (charger) 100-240 Vac, 0.3-0.6 A, 50-60 Hz Battery: Type Lithium-Polymer Battery: Capacity 1100 mAh... -
Page 43: Certification
13. Certification Standard Harmonized Application Used to establish the information EN 1041:2008 needed for product use and Information supplied by the manufacturer of medical general aspects devices presentation of information Used to set the appearance of EN 15223-1:2016 graphical symbols included in the Symbols for use in the labeling of medical devices labeling of our product. - Page 44 REV 1.3 – MARCH 2019...
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