gempro user manual - measureandknow.com operators manual - rev e.pdfgempro user manual indication...

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DDME Contact Information: 1.800.513.9337 or email: [email protected] 1929 Corta Bella Dr. Las Vegas, NV. 89134

GEMPro USER MANUAL

INDICATION FOR USE: The GEMPro is a wellness monitor intended to assess the quality of sleep using 5

parameters, SpO2 (Oxygen Saturation of the blood), Heart Rate, EMG of the masseter muscle, Snoring,

and Body Position.

TABLE OF CONTENTS

Section 1: Updating the Application from Google Play Store Page 2

Section 2: Setting up a Self-Test Page 4

Section 3: Setting up a Prescriber Test Page 6

Section 4: Acquiring a Study Using a PIN Page 9

Section 5: After Acquiring a Test Page 13

Section 6: Report Overview Page 14

Section 7: Physioplux Pro – Processing App Page 25

mailto:[email protected]

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Section 1: Updating the Application from Google Play Store and

initializing Application

Any updates to this application will be available in the “Play Store” hosted by Google. If you receive a message indicating an update is available take the following steps. Here are the steps to update your GEMPro:

1. Click the “Play Store” icon from the tablet mail menu

2. In the search box for Play Store, type in “DDME Bruxism”

3. Select Physioplux for Bruxism

4. Click the “Update” button. Once the update is completed, ensure “physioplux for bruxism” is updated to the most recent version. The version number is located in the lower right corner of the Main Screen.


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Physioplux for Bruxism – Main Screen

5. INDIVIDUAL ACCOUNT: a. SELF TEST is designed for the owner of the system to perform a study on themselves.

6. PRESCRIBER ACCOUNT: a. Facebook is used when the prescriber is using their own facebook account login

information to log into their Prescriber Account. b. Google is used when the prescriber is using their own facebook account login

information to log into their Prescriber Account. c. “MeasureAndKnow” is used when the prescriber is using their own facebook account

login information to log into their Prescriber Account. The login credentials for this account login path are provided by DDME at the time the GEMPro system is purchased.

d. Alternate is not currently in use but intended for future features. 7. PATIENT LOGIN:

Patient login is used for patients who have been seen by a dentist for which the Prescriber has set up the tablet specifically for the patient to perform a measurement. The Prescriber will issue a 4-digit PIN code which will always start with and “R” or “T” code.

a. Patients will enter the 4-digit PIN issued by their Prescriber to log into the Physioplux Application to initiate their study.


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Section 2: Setting up a SELF TEST The purpose of a SELF TEST is for the user of the system to perform their own study. To perform a SELF- TEST, take the following steps. Click the SELF TEST button located on the Physioplux Main screen. This action will open the Patient Demographic form seen below. After selecting “Self-Test”, the user may be asked to enable Bluetooth. Select “Yes” and use the login Gmail or Facebook address used when registering the GemPro

TIP: When filling out the Self-Test form use the “NEXT” button located on the keyboard to advance to the next field. To open the keyboard, click in a field.

8. Fill in the Date of Birth Optional

Select month and day, click year Scroll to select year


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9. Height: Optional 10. Weight: Optional 11. Create and enter a 4 Digit PIN. Be sure to document the PIN once it is entered twice. This PIN

can be used over and over after created the first time. 12. There is not a requirement to fill in the Visual Tooth Inspection information, but if done the data

appears on the emailed report. 13. Optionally a user can email a copy of the report for backup by placing a check in the “Submit

report to DDME for cloud storage as a backup” 14. Click, “Register PIN” 15. The screen will advance to the hardware pairing and study information screen as seen below.

Capture correct image

16. Enter the estimated number of studies you will perform. The patient may perform more or less than the number entered.

17. Enter the number of hours per night you wish to sleep each night. During the acquisition, the large circle will have a hash mark on the number of hours entered here. Once the number of hours is achieved, the progress circle will turn from orange to green.

18. Turn on the power to the Biobrux amplifier and the pulse oximeter. The Biobrux amplifier has a

toggle switch on its side (0 is off, 1 is on). The pulse oximeter is turned on by pushing on the blue button.


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Biobrux Amplifier Pulse Oximeter

19. Click the “Scan” button and wait for the MAC addresses appear in the EMG device and SpO2 device fields. Be sure the MAC addresses are not 00:00:00:00:00:00.

20. Click the “SAVE” button. 21. The app will display a message asking if you would like to start the test immediately. Answer

appropriately and proceed accordingly. NOTE: If you are starting the study you will be prompted to follow the on-screen instructions, skip to Section 4: Acquiring a Study. If the test is to be started later with a PIN, also skip to Section 4: Acquiring a Study

Section 3: Setting up a Prescriber Test

When a GEMPro is purchased, a Prescriber Account is created and included in the shipment documentation. The account will include a username and password. In addition, a “Cloud” based configuration protocol will be set up which will include the prescriber’s email address, account name, device hardware assigned to the account and activation of all purchased features. Available Configurations: GEM – Oximeter only test system GEMPro – Oximeter and Biobrux amp Processing App – advanced Reporting and display capabilities

Prescriber: Set-Up A Study Login to the prescriber account using the account information provided.


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The first screen in the prescriber screen is the patient demographic form which includes basic patient information and visual tooth inspection score. In addition, the app generates two types in patient PIN numbers: RXXX (report only at the end of acquisition) and TXXX which is (report at acquisition end, and data transmission). Transmitted data can be further analyzed by the Processing App. The TXXX PIN is only available if the APPLICATION is authorized to do transmissions and post-processing. Contact your provider if the TXXX PIN number does not appear and the user believes it should be authorized. NOTE: BE SURE TO WRITE DOWN THE PIN NUMBERS ASSIGNED. THESE PIN NUMBERS ARE WHAT IS GIVEN TO THE PATIENT TO START A STUDY

1. Unique Patient ID: This field is a unique patient field which is commonly used as the patient number assigned in the office.

2. Date of Birth: Optional


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Select month and day, click year Scroll to select year

3. Height: Optional 4. Weight: Optional 5. There is not a requirement to fill in the Visual Tooth Inspection information, but if done the data

appears on the emailed report. 6. Click, “Register PIN”. If the same email is used, the DDME portal will ask if the patient is the

same as a previous patient with the same email. If so, the data entered will replace the previous patient information. The email address is what differentiates patients in the DDME portal. If the patient and PIN were successfully registered, the screen replaces the “Register” button with the “Next” button. Press “Next” to advance the Menu.

7. The screen will advance to the hardware pairing and study information screen as seen below.

Capture correct image

8. Enter the estimated number of studies you will perform. The patient may perform more or less than the number entered.

9. Enter the number of hours per night you wish to sleep each night. During the acquisition, the large circle will have a hash mark on the number of hours entered here. Once the number of hours is achieved, the progress circle will turn from orange to green. Also a reason for the test can be selected.


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10. Turn on the power to the Biobrux amplifier and the pulse oximeter. The Biobrux amplifier has a

toggle switch on its side (0 is off, 1 is on). The pulse oximeter is turned on by pushing on the blue button.

Biobrux Amplifier Pulse Oximeter

11. Click the “Scan” button and wait for the MAC addresses appear in the EMG device and SpO2 device fields. Be sure the MAC addresses are not 00:00:00:00:00:00.

12. Click the “DONE” button when the scan for the Bluetooth devices is complete and the MAC Addresses for the devices are filled in.

13. The tablet is now ready to start an acquisition by PIN number.

Section 4: Acquiring a Study Using a PIN (Either from Self-Test or Prescriber Patient Set-up)

14. If you are starting the test later you will need your 4-digit PIN. This PIN is created automatically

in the Prescriber 15. Enter the 4-digit PIN in the field located at the bottom of the Physioplux main screen. 16. Click the “NEXT” button 17. Power up the Biobrux amplifier and the Pulse Oximeter.


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18. The tablet must be plugged into the wall using the USB wall plug included with the system. 19. Wait for the EMG and Spo2 devices to become recognized indicated with a green check. 20. Confirm all 3 green checks are visible (swipe) left or click the right arrow button.

NOTE: If the tablet asks for Bluetooth code, wait until the message goes away 21. Applying Therapy: If you are wearing an appliance, answer yes. (swipe) 22. Instructions on placing the Biobrux amp and EMG surface pad on the masseter muscle

a. Open the Biobrux clip

b. Follow the on-screen instruction for amp placement c. Use the second clip to stabilize the amp

23. Locate your masseter muscle by clenching your teeth and feeling your cheek muscle. Where you feel your muscle bulge is where your masseter muscle is located.

24. Remove the clear plastic sheath and place the EMG foam pad in a vertical orientation on the masseter muscle (swipe)

25. Amp orientation, with the amp in place on your night shirt confirm the black arrow on the amp is pointing straight up. (swipe)


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26. Place the wrist oximeter on the non-dominant hand, then place the finger probe on the index

finger. If the finger probe becomes uncomfortable through the night, you may move the finger probe to an alternate finger.

27. Power up the oximeter by pressing the Blue button

` NOTE: EMG Calibration is performed to assess the relative strength of the parafunctional EMG

activity\bruxism while asleep compared to waking maximum clench force. 28. With the Biobrux amp turned on, and the

EMG sensor placed on the masseter, press the “Play” button on the application.

29. Follow the on-screen instructions to complete the EMG Calibration. You will be asked to cycle between Relaxing and Clenching your teeth as hard as you can 3 times.

30. Ambient noise calibration fro Snore detection is started by clicking the “Play” button. It is important to remain quite during the noise Calibration.

31. Set the delay time from 1 minute to 10 minutes. NOTE: The estimated awake time is based on the start test time plus the number of hours for the study selected during the set-up portion of the study.

32. Turn off the LED on the front of the biobrux amp by clicking the blue button located just above the “NEXT” button.


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33. Click the “Next” button and the application will wait for the timer to expire to begin data

acquisition. Alternatively, click the “Start Test Now” button to start the test immediately.

34. When the timer expires or the user selects “Start Test Now”, the application begins collecting data.

Running Acquisition Once acquisition has started, the screen will look like the image below.


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One of the primary features of the acquisition screen is the center circle which indicates the amount of study that has progressed. The progression is illustrated by the orange line following the circle. The end goal of time sleeping in indicated by the hash mark.

Once the total time for the test has been reached, the circle turns green. There is also a “Pause Button” located in the center of the circle which is designed to pause the test if needed. NOTE: It is NOT necessary to pause the test if visiting the restroom during as the system will manage the acquisition automatically. To conclude the test, click the “End Test” button. Once the End Test button is pressed, the tablet app will calculate the report and prepare it for email transmission. If the WIFI is configured, the PDF report will be sent. However, if WIFI is not configured the study will be saved until WIFI is available and the correct PIN number is entered.

Section 5: After Acquiring a Test

Upon completion of the study, the acquisition application will calculate a report in the PDF format and

send the report to the email associated with the prescriber and optionally to the individual taking the

test or in the case of the Self-Test, the email entered when setting up the test. In addition, the

acquisition will display a series of graphs once the PDF report is sent or stored.

Tablet Graphs

The first graph displayed is the SpO2 and you scan scroll down to view the Heart

Rate graph

SpO2 / Heart Rate Graph

To view the Bruxism Graph, click the Bruxism Tab

Bruxism Graph

To view the Audio\Snoring graph click the Audio Tab

Snore Graph

To exit the posttest graphs, click the NEXT button


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Report Overview

PDF Reports The PDF reports are emailed to the email address associated with the Prescriber’s account either at the completion of the test in the case where the patient configured WIFI or when the tablet is returned to the Prescriber’s office and the test PIN is reentered and the acquisition app will automatically send the PDF report.


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Report Header and Patient Demographics

The patient information in the header of the report is entered while setting up the study in “Prescriber Mode”

SpO2 Graph

This is a bar graph which represents the range of data the bar graph represents. Artifact: It in not uncommon to see spikes in data especially during body position changes. The software generally tags these as artifact and does not include them in the numerical section of the report.


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Heart Rate Graph

This is a bar graph which represents the range of heart rate data for the time the bar graph represents. The colors of the heart rate graph indicate the body position during the time the color represents. The boxes represent the maximum and minimum heart rate and well as the time below 40bpm and time over 100bpm. Note the right, (yellow) portion of the graph is significantly narrower indicating a more stable heart rate than seen while sleeping supine, (red).

Bruxism\Parafunction Analysis

Night Max Force: The strongest parafunction event detected while asleep.


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Biocal Max Force: Before the test is started, the app prompts the person to bite down as hard as they can then relax 4 times. The biocal max force represents the strongest bite force recorded during the calibration while awake. Number of Events: The boxes labeled >10%, >25%, >50%, >75% and >100% are populated with parafunctional EMG events compared to the max biocal force (waking max force). Max/Biocal Ratio: This is the ratio comparing the waking max biocal clench force compared to the strongest parafunctional event while asleep. A value greater than 1 indicates the clench force while asleep is stronger than the waking max biocal force. A value less than 1 indicates the waking max biocal force is higher than the strongest force recorded while asleep.

Audio\Snoring Analysis

The color of the graph indicates the body position. Audible snore minutes: The tablet calculates the audio recording the amount of time which meets the snoring criteria. Percentage of Time Snoring: The value represents the percentage of time of sleep the patient spent snoring.

Bio-Calibration – Waking Maximum Waking Bite Force

During the pre-test activity, the Physioplux app will direct the patient to bite down hard then relax 4 times. The purpose of capturing the waking maximum bite force is to assess how hard the patient can bite down


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while awake. This value is saved then used to compare the measured strength of parafunction while the patient sleeps. Night Max Force is the strongest parafunctional activity recorded during the study. BioCal Max Force is the strongest clench recorded during calibration. Max\Biocal Ratio is the difference between the two values. A value greater than 1 indicates the parafunction while asleep is stronger than the waking calibration. A value less than 1 indicates the waking clench was stronger than the parafunction occurring while asleep.

All graphs are drawn by color by body position.

Red – Supine Green – Left Yellow - Prone Blue – Right Gray - Up


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Report Interpretation – GEMPro When a GEMPro measurement is completed a report is created based on the graphs created during the study. There are 5 component graphs and the bio-calibration represented in the report. (see biocal in the operator’s manual). The section of the manual is intended to assist the prescriber interpreting the graph report. For report definitions can found in the report section of the operator’s manual. Oxygen SpO2 Graph Oxygen saturation level is a function of the cardio respiratory system and is a key indicator of existing airway functionality. The presence of oxygen desaturations are represented by the lowering of the oxygen levels depicted by the lowering of the bar graphs. In addition, there are 5 bins summarizing the SpO2 levels during the measurement.

Normal SpO2 graph with body position artifact

Artifact from body position change


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Normal graph and the patient is out of range of the tablet receiving data from the sensors. This usually occurs when the patient goes to the restroom.

Unseen artifact: This usually occurs when the sensors are removed before the test is ended. The last minute(s) of the test will be artifact and may not be obvious.

Oxygen Desaturations Indicating Medical Intervention Referral. There are three axis of consideration assessing blood oxygen desaturations: Frequency, Depth and time below normal values. The GEMPro graphs report on depth, (how low does the oxygen go) and time below thresholds. The GEMPro application does NOT calculate frequency of oxygen desaturations. The guidelines are open to your own judgement based on a variety of factors such as: is the patient symptomatic, are there other variables which led you one way or the other but we offer a few basic common-sense recommendations. Our recommendations represent the likelihood a graph predicts is significant airway disorder. The terms we will use are High, Moderate and Low likelihood the graph indicates the presence of an airway disorder. A normal graph represents a very low likelihood the graph indicates the presence of an airway issue.

Normal SpO2 graph is generally devoid of any desaturations below 90% and little or no time is reported below 92%.

Gap in data from being out of Bluetooth range

Sensors removed before test ended


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Low likelihood of the presence of an airway disorder. A few oxygen desaturations below 92% with a low percentage of time at or below 92% and no time below 89% ?????

Moderate likelihood of the presence of an airway disorder. Any amount of time at or below 89% indicates a moderate likelihood of the presence of an airway disorder. ????

Artifact


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High likelihood of the presence of an airway disorder. Any amount of time at or below 85%.

Low SpO2 baseline indicates a possible pre-existing respiratory issue which may or may not be related to an airway. As such, when a baseline below 90% is noted the patient should be referred to a specialist for evaluation.

Below 90% Baseline


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Severe oxygen desaturation and a normal heart rate graph is an indication of possible heart condition. These types of outcomes should be referred to a specialist with a high priority.

Relatively normal SpO2 graph in the presence of excessive heart rate variability indicates disturbed

sleep. Commonly this is associated with Upper Airway Resistance, (UARS) or Respiratory Effort

Related Arousals, (RERA’s)


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Normal EMG activity level: The Max biocal ratio is well below 1, the total number of EMG bursts is well below 200 and only 2 bursts, (weak clenches) are 50% of the waking calibration level.

Mild to Moderate Parafunctional EMG activity. Night time max force is 1,6 times as strong as when

awake. It is interesting to note the positional parafunctional activity while supine (red)


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Severe Parafunctional Activity: The night time parafunction is 1.62 times as strong than the waking

bite force. There are 19 EMG events 50% or stronger than the waking bite force.


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PhysioPlux Pro – Processing Application The PhysioPlux processing application is designed to provide the advanced user with more specific information related to the airway performance in addition to frequency and magnitude of the parafunctional activity. Moreover, it allows the user to review the raw data in a variety of time segments. Finally, report generation has several features not available in the default acquisition report. Installing and Updating PhysioPlux Pro Here are the steps to update your GEMPro:

1. Click the “Play Store” icon from the tablet mail menu

2. In the search box for Play Store, type in “DDME Bruxism”

3. Select Physioplux Pro for Bruxism (Gold Tooth)

4. Once the PhysioPlux Pro for Bruxism is selected, click Install. If already installed and you are updating then click “Update”

5. Once installed or updated, the version number is in the lower right corner of the Main Screen.


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To gain access to PhysioPlux Pro two requirements need to be met:

1. First is your account needs to be activated. If not already activated, call DDME for activation activate.

2. Secondly, the prescriber needs to start using “T” PIN numbers when collecting data. Only studies collected using PIN numbers which start with “T” are available in the PhysioPlux Pro app.

3. Once these requirements are met log into PhysioPlux Pro using your existing Prescriber login credentials.

Log in by clicking the PhysioPlux Pro icon (gold tooth) and enter your current login credentials. You will see the following screen:

NOTE: If a study is ready to be automatically imported into the PhysioPlux Pro app it will be displayed first and will request to be imported.


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To use any of the features available in PhysioPlux Pro, click on any item associated with the patient data such as Patient Name, Patient ID or Studies.

If this is the first time the study has been opened, it will take several minutes to prepare the raw data. Once the raw data has been prepared the study opens quickly.

PhysioPlux Pro – Main Screen

Change Snore Threshold: This feature allows the user to adjust the sensitivity of snore detection based on environmental circumstances.

1. View the Snore graph and determine an adjustment is warranted. 2. The dotted blue line is the current sensitivity level for the snore calculations 3. To change the level of the dotted blue line, click “Change Snore Threshold”


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4. To make the snore channel more sensitive, move the dotted blue line down, lower the number on the number line below its current setting. To make the snore channel less sensitive, increase the number above its current setting which raises the blue dotted line.

5. Click OK and re-select the snore graph and the updated snore information is available

to view and Send PDF report to print. Adjusting the raw data time frame: There are 2 ways to adjust the time frame, first is prune the data to a selected period of the study and secondly is adjust the amount of time scale for which the screen represents. To move to a selected time frame or prune the data or move to a selected point in time, select the Start-End Time control located on the upper left corner of the main screen.

Then use the scrolling time control to select the beginning and\or ending time of the study.

Note: The number pad can be sued to enter the start or end time.

Note: You can also generate a report based on the data range selected by clicking the Send PDF Report button found on the top row of buttons on the main screen.

Adjust the time scale by click the “Full Study” drop down control which offers times scales ranging from Full Study to 1 minute. The candle sticks which constitute the graphs represent various time frames based on the epoch length.


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Full study graph

Four-hour graph – scores displayed with purple marks

Two-minute graph

When the time scale is larger than the screen can display, the balance of the data can be reviewed by scrolling using the “swipe” motion. Bruxism Analysis Along with displaying the graph configuration selected, Bruxism Analysis can also calculate a number of detailed parameters indicating both the frequency (index) and magnitude (% waking clench) on the time period selected.


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Parameter Definitions Night Max Force: The strongest EMG signal measured during the study. BioCal Max Force: The strongest EMG signal measured during the pre-test bio-calibration. Force Ratio: The ratio between the Night Max Force and the BioCal Max Force. A value greater than 1 indicated the strongest EMG signal measured occurred during the test. A value less than 1 indicates the strongest EMG signal measured occurred while the patient was awake. Total Time Eliminated: An artifact algorithm is run on the data and the data eliminated is summed and displayed in minutes. Total Energy: Based on the BioCal value measured, the relative strength of events is estimated. The value of each event is summed and reported as Total Energy. Classified Events Total: Burst: Detected EMG which does not qualify as a clench or Grind

Grinds: An elevated EMG event at least 50% of the magnitude of the waking clench force lasting from 2.5to 12 seconds. Weak Clench: An EMG burst with a measured strength between 25% to 50% of the waking maximum clench force which lasts between 0.5 to 3.0 seconds. Strong Clench: An EMG burst with a measured strength greater than 50% of the waking maximum clench force. BBI: Bruxism Burst Index = the total number of bursts divided by the Total Test Time multiplied by 60. BEI: Bruxism Event Index = the total number of clenches and grinds summed, divided by Total Test Time multiplied by 60. The above calculations are made by sides and supine only to determine if positionality is a factor in triggering parafunctional activity.

Oxygen Desaturation Index: An oxygen desaturation is defined as a drop in the measured blood oxygen level of at least 4% from current baseline. The index is the number of 4% desaturations. Chick to visualize analyzed data in the charts: This feature is designed to display the events which were detected by the autoscoring algorithms. These events are displayed using a purple color overlay of the available charts.

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