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Summary of Verification Test Results
Summary of Verification Test Results
The Device is:
Under the maximum weight.
Able to accurately threshold each sensor with 90% confidence.
Able to mount the OTC within 7cm of the dorsal side of the hand.
Able to fix the OTC to a location on the hand and maintain the position within 5cm in either direction with 99% confidence during vigorous use.
Able to connect to the OQ via Bluetooth.
Able to be recognized as an input device because of it's native USB support.
Able to indicate that it is charging.
Able to get the same signal between identical bends of a flex sensor with 95% confidence.
Able to get the same signal between identical stresses on the force sensor with 95% confidence.
Able to power itself with the onboard battery which is within the voltage requirements.
Able to contain the electronics without causing them to overheat.
Not at risk of causing skin abrasion and irritation.
The Device is NOT:
Able to communicate the disconnection of the Bluetooth signal.
Confirmed to have a battery life which would allow for extended use of up to 1 hour.
Confirmed to be intuitive to equip.
Able to be equipped by a patient with SMA III.
Confirmed to not have any long term adverse effects.
Test Description and Details
Test Description and Details
7. User Derived Requirements
7.1 Weight Requirement
Test Methods: The entire system will be weighed on a scale 20 times. The average weight of the system should not exceed 377 grams. The test must pass 19/20 times to achieve a 95% confidence interval.
Conclusion: The glove will not exceed the maximum weight limit.
7.2 Adjustability Requirement
Test Methods: This would be tested by fixing the controller to the test bench and then applying a known load to each sensor then checking input results in the application when 80% of calibration load is applied to each sensor. If each sensor is thresholded to 80% of the given load, then the system is said to have successfully calibrated. The test must pass 18/20 times to achieve a 90% confidence interval.
Conclusion: The sensors are able to be thresholded with a 90% confidence.
7.3 Maneuverability Requirement
Test Methods: The entire system will be measured using a caliper 20 times. The average height of the system should not exceed 7 centimeters. The test must pass 19/20 times to achieve a 95% confidence interval.
This requirement is no longer a concern as the glove was redesigned to move the electronics to a compartment on the forearm. The new height of the OTC mount is 1.73 cm.
8. FUNCTIONAL & PERFORMANCE REQUIREMENTS
8.1 Fixation to the hand
Test Methods:
For rotation test, pigmented stickers are placed on an arbitrary point on the longitudinal centerline of the OTC and the edge of the mount where it comes into contact with the OTC such that the lines connecting these two markers are perpendicular to the longitudinal centerline of the OTC.Wearing the mounted OTC on their hand, the subject is asked to perform a set of actions that mimic the actions the patient will do during the exercise per trial. After each trial, a digital caliper is used to measure the distance between the markers. The change in distance in each trial is calculated by subtracting the first measurement from the measurement of the respective trial. The test passes if the displacement does not exceed 50 mm over 10/10 trials.
For shift test, pigmented stickers are placed on the same position of the OTC as in the rotation test and on the further knuckle of the middle finger of the subject. Wearing the mounted OTC on their hand, the subject is asked to perform a set of actions that mimic the actions the patient will do during the exercise per trial. After each trial, a digital caliper is used to measure the distance between the markers. The change in distance in each trial is calculated by subtracting the first measurement from the measurement of the respective trial. The test passes if the displacement does not exceed 50 mm over 9/10 trials to achieve 90% confidence interval.
Conclusion: The OTC mount holds the position of the OTC constant after vigorous use, making it an adequate substitute for holding the controller.
8.2 Electrical Component and Circuit Functionality
8.2.1 Bluetooth connectivity
Test method: Following the steps specified in the source above, the controller must connect successfully to OQ. Between two consecutive Bluetooth connectivity tests, the Oculus App should be restarted and OQ should be reconnected to the Oculus App. The test must pass 15/20 times to achieve 75% confidence interval.
This test passed with a 20/20 rate, the glove is recognized as a Bluetooth device by the Quest.
8.2.2 Native USB connectivity
Test method: Using a USB 2.0 cable to connect the USB port of the controller to the USB port of a desktop, USB connectivity is confirmed by looking at the connection listed under Device Manager/Universal Bus Controllers. This only needs to be done once for confirmation.
This test was a success, the computer recognized the glove as an input device both in wired and bluetooth mode. It was able to print characters in a blank notepad document as well.
8.2.3 Battery Charging LED
Test Method: Using a USB cable to connect the microcontroller to a powered-on desktop. The LED will be automatically illuminated when the microcontroller receives electric power. If this happens, the test passes. If the light remains off, the test fails. The test should pass 19/20 times to achieve 95% confidence interval.
This test passes with a 20/20 rate, the light will turn on when the glove is charging.
8.3 Sensor Reliability
8.3.1 Flex Sensor
Test Method: The flex sensor outputs when bent at a specified α angle (confirmed by the goniometer) are recorded and compared among each other. A 95% confidence interval was constructed and if the difference between the upper control limit and the lower control limit was greater than 10% of the mean, the test failed.
Conclusion: The Flex sensors are consistent enough to be used in this device as the readings will not vary significantly.
8.3.2 Force Sensor
Test Method: The force sensor outputs when compressed by a specified 50 gram weight are recorded and compared among each other. A 95% confidence interval was constructed and if the difference between the upper control limit and the lower control limit was greater than 10% of the mean, the test failed.
Conclusion: The force sensor is consistent enough to be used in this device as the reading will not vary significantly.
9. INTERFACING REQUIREMENTS
9.1 Data Communication
Test Method: By conducting the test listed under 10.1, the ability for the device to communicate with the headset wirelessly will be tested as a byproduct. The test must be repeated 20 times with at least 19 tests passing to achieve a 95% confidence interval.
This test would result in a failure because the application cannot communicate with the glove. However, this was accounted for in a redesign where the original need for two way communication (calibration) was reworked to only require one way communication. The glove can communicate with the Quest and passed a basic test for this with a 20/20 rate.
10. HUMAN FACTORS, EASE OF USE, ERGONOMICS
10.1 High Salience Alert System
Test Method: To test if the system can detect a disconnected glove, a test should be set up such that the glove is connected to the application, and then the battery is disconnected at the same time a timer is started. The timer is stopped when the alert is given. This test should be repeated 20 times with 19 or more passing for a 95% accuracy. The same test should then be run for exercise failure alert. A new Unity scene should be developed such that pressing a button fails the exercise and starts a timer. The timer stops when the alarm is thrown. This test should be repeated 20 times with 19 or more passing for a 95% accuracy. Finally, a scene should be constructed such that the alarm will be thrown at a random time and stop when the button is pressed. The total interval of the active alarm time would be recorded and accepted if it is less than 1 second. This test should be repeated 20 times with 19 or more passing for a 95% accuracy.
Given the limitation mentioned in 9.1, we redesigned the test so that the glove would be disconnected and then a stopwatch started. The user would verbally indicate when the “disconnected” message arrived. This time is used in the same way as the aforementioned time. Additionally, the detection of the disconnect was done through Oculus defaults so the threshold of failure was increased to 20 seconds.
Conclusion: While this alert system is slower than we originally wanted. Given the limitation it is acceptable as the user would know they lost connection within a reasonable amount of time.
10.2 Labeling and Affordances
Test Method: The test would consist of providing a new user with the controller and asking them to equip it. They would be timed while doing this and the test would be considered a success if they could equip it in 5 minutes without guidance. Another proctor would be present to assist with the physical strapping, but only when directly guided by the user. This test should be repeated 20 times with 19 or more passing for a 95% accuracy.
This test was unable to be run given the fact that it required 20 users and this was too difficult to organize in the time window while also meeting COVID regulations. It was accounted for in the final tests by having multiple team members on call to assist in equipping and using the device.
11. ENERGY - HEAT, ELECTRICAL
11.1 Power Source
Test Method: Connect the battery to a breadboard and connect a voltmeter in parallel. If the reading is greater than 3.7 and less than 4.2, the test is a pass. The test must be repeated 20 times with at least 19 tests passing to achieve a 95% confidence interval.
Conclusion: The power source clearly has more voltage than is necessary to power the adafruit feather 32u4. The device can also be said to not exceed the maximum allowed voltage.
11.2 Battery Life
Test Method: Connect the controller to a Quest running a Unity scene that begins a timer when one of the flex sensors is bent and stops when the signal is lost. Bend and fix the sensor and check back when the battery has run out and the controller has disconnected. Test passes if the timer is 2 hrs or more. The test must be repeated 20 times with at least 19 tests passing to achieve a 95% confidence interval.
This test could not be completed in the time requirement given the application could not internally detect the disconnection of the glove. Given this issue, there was not time to devise a more manual method of testing battery life.
1.11.3 Temperature
Test Method: Repeat the test in 14.2 and record the temperature at the end. If the temperature is below 130oC, the test is accepted as a pass. This test should be repeated 20 times with 19 or more passing for a 95% accuracy.
The number of tests required for this requirement was reduced to 5 as the results showed no risk of reaching critical temperatures.
Conclusion: The micro controller will not run hot enough to melt the PCB.
12. BIOLOGICAL - TOXICITY, BIOCOMPATIBILITY
12.1 Skin Abrasion
Test Method: After wearing the product for 30 minutes (the average length of an RT session), a patient’s skin must not show any signs of redness or irritation. If no redness or irritation can be visually detected by the test observer, the test is passed. The test must be repeated 20 times with at least 19 tests passing to achieve a 95% confidence interval.
This test was unable to be run given the fact that it required 20 users and this was too difficult to organize in the time window while also meeting COVID regulations. It was accounted for by having each team member wearing the glove for 15 minutes and checking for abrasion. The glove passed this test with a rate of 5/5.
12.2 Allergies (latex, phthalates)
Test Method: After wearing the product for 30 minutes (the average length of an RT session), a patient’s skin must not show any signs of redness or irritation, or any other signs of an allergic reaction. If no redness or irritation can be visually detected by the test observer, the test is passed. The test must be repeated 20 times with at least 19 tests passing to achieve a 95% confidence interval.
This requirement is no longer applicable as we changed the design of the device to not contain any major allergens. While Silicon can have an allergic reaction in rare circumstances, our patient is not allergic.
12.3 Heavy Metals
No test was required.
12.4 Blood Contact
No test was required.
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