D27-8206-2 Rev 9

FREQUENTLY ASKED QUESTIONS

A. GETTING STARTED: RESPONSES TO 3 QUESTIONS

B. USING THE NIGHT SHIFT: SOLUTIONS FOR 18 POTENTIAL ISSUES

C. NIGHT SHIFT REPORTS: SOLUTIONS FOR 10 COMMON QUESTIONS

D. NIGHT SHIFT SOFTWARE FEATURES: INSTRUCTIONS FOR 6 POTENTIAL ISSUES

E. NIGHT SHIFT BATTERY AND VIBRATION TEST: CONFIRM YOUR DEVICE IS WORKING

F. NIGHT SHIFT EXPECTED SERVICE LIFE

G. NIGHT SHIFT WARRANTY

H. ADDITIONAL TECHNICAL INFORMATION AND SAFETY REQUIREMENTS

I. NIGHT SHIFT TECHNICAL SUPPORT


A. Getting Started: Responses to 3 Questions

Q1: How can I access the Night Shift software to generate reports and manage the device?

A: Please follow these directions:

  1. Go to www.NightShiftTherapy.com
  2. Click Portal
  3. Click Register & Manage Device/Generate Reports
  4. Click Download for Windows or Download for Mac, as applicable
  5. Install the downloaded software
  6. Click to launch the application when prompted
  7. The software will open in a new window

If you need additional assistance setting up your computer for use with the Night Shift software, please click the following link, https://nightshifttherapy.com/software-download/, and follow the directions for your operating system and browser.

Q2: Why does the “Wrong Time/Date” message appear when I first connect my device to the Night Shift software?

A: If you see the “Wrong Time/Date” message, that means that the time/date on the Night Shift device is different than the time/date on your computer. Click the “Update Device Time & Date” button to update the device to the same time/date as your computer. The Night Shift device is shipped with the internal clock set to the Pacific Time zone. If the battery charge gets too low, the date cannot be maintained on the device. Either of these conditions can cause the time/date to be incorrect.

Q3: How is my personal data secured when I use the Night Shift software?

A: Using the Register Your Night Shift Device Only button, your email address (and name if entered) will be saved securely on our server. We will use this information in the event of a recall or for Night Shift updates. Your name/email will not be saved to your device.

If you choose to use the Register & Manage Device/Generate Reports button, your data is encrypted prior to generation of the PDF report. Each time a report is generated, we save a copy of the data as a backup in case you need to restore your data. These files are stored on a secure server with the name encrypted. Click here to read the Privacy Disclosure for the Night Shift software.

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B. Using the Night Shift: Solutions for 18 Potential Issues

Q4: What is the green LED pattern when I turn on the device?

A: When the device is turned on, it will vibrate 1-3 times and blink green 1-3 times, depending upon how many nights the device has battery charge sufficient to record. The device will then continue to blink green for 5 minutes. After 5 minutes, the LED will display a solid green light which means the device is recording as expected.

Q5: My device vibrates in every position. What is wrong?

A: When the battery gets very low, the device goes into a warning mode where it blinks a yellow light and vibrates once every five seconds, regardless of position. This indicates that the device needs to be charged. If you believe the device is fully charged, click here for instructions to test the functionality of your Night Shift.

Q6: Why did the magnets come out of my neck strap?

A: The neck strap should be inspected regularly for signs of deterioration due to normal wear and tear. It is recommended that the neck strap be replaced every six months. If you disconnect the magnetic clasp by pulling the ends apart, the material stretches and can tear. To avoid this problem in the future, be sure to unclasp the strap by bending at a 90° angle, like snapping a stick. Please review step 9 of the User Instructions.

Q7: How often should I expect to replace my strap?

A: It is recommended to replace the strap every 6 months.

Q8: How do I purchase a new neck strap or chest belt?

A: If you live in the United States, click here to order a new strap or chest belt. All other users should contact their local Night Shift Provider to purchase a replacement neck strap or chest belt.

Q9: How should I clean my device?

A: See page 2 of the User Instructions for the Night Shift cleaning procedures. Note that the chest belt should be cleaned using the same method as the neck strap.

Q10: The Night Shift starts vibrating as soon as I try to sleep on my back! I thought it was supposed to give me 15 minutes to fall asleep first?

A: After being turned on, the Night Shift is designed to wait 15 minutes before delivering positional feedback. If the on/off button is held down for more than 7 seconds, the device turns on in “test” mode, and feedback begins immediately. If this is the case, turn the device off. When you turn it back on, only hold the on/off button down for 1 second.

Q11: My Night Shift will not turn on.

A: If the battery is completely dead, the device will not turn on. Please fully charge the device and press the on/off button for 1 second. If the device still does not turn on, click here for instructions to test the functionality of your Night Shift.

Q12: I’ve charged my Night Shift but the battery does not hold a charge.

A: This is most often a problem of a bad cable rather than a problem with the Night Shift battery. The Night Shift can be charged with any standard micro-USB cable. Please try to charge the device with a different cable. If this does not solve the problem, click here for instructions to test the functionality of your Night Shift.

Q13: When I woke up in the morning, the device was turned off. What happened?

A: To conserve the battery and increase the accuracy of your report, the Night Shift automatically turns off after 10 hours. If you need to change the settings to 12 hours instead of 10 hours, follow these steps:

  1. Open the Night Shift Software (or follow the directions in Q1 to download, install and open the software)
  2. Plug in your Night Shift device
  3. Click Manage Device
  4. Click F12 on your keyboard and the Max Recording Time window will appear
  5. Click 12 hours and click Save

If the device turned off prior to your setting of 10 or 12 hours, click here for instructions to test the functionality of your Night Shift.

Q14: I would like to try the device for a night with no feedback vibrations to see how I’m sleeping without it, is that possible?

A: Yes. Using the Night Shift software, click Manage Device. In the Positional Vibration Setting box, check the box for No vibration, then click Save. The device is now set to record without providing feedback vibrations. After a night or two in no vibration mode, be sure to return to the software and change the vibration setting back to “After 15 minutes” or “After 30 minutes.” (Note: If you do not have the Night Shift software, please click here for instructions on downloading the software.)

Q15: What is trial mode?

A: A: When the Night Shift is set to trial mode, no vibration feedback will be delivered on the first night the device is worn to enable you to obtain a baseline session. This baseline session is permanently presented as one of the nights in your detailed report. Positional vibration feedback will automatically begin on the second night you wear the device, and it will continue for all future nights that you wear the device in trial mode.

Q16: After wearing the Night Shift for awhile it seems that I’m taking longer to move off my back when the vibration is delivered, can the vibration intensity be increased?

A: If the Night Shift is working properly, the vibration intensity should increase (after six vibrations at each level) a total of seven times. Following the six vibrations at the seventh level, the vibration intensity and frequency should begin a random pattern. To ensure the Night Shift is delivering the maximum vibration intensity, click here for instructions to test the functionality of your Night Shift.

Q17: Does the Night Shift have larger size straps for those patients who have bigger necks than the size of the standard bands?

A: The neck strap can be adjusted to accommodate a maximum of a 22 inch (56 cm) neck. The Night Shift Chest Belt can also be used as an alternative to the Neck Strap and can accommodate chest sizes up to 59 inches.

Q18: I have received my new Chest Belt, how do I set up my Night Shift to be used with the Chest Belt?

A: In order to use the Chest Belt, the settings on your Night Shift device must first be changed. Follow these directions to change your Night Shift settings:

  1. Open the Night Shift Software (If you have not done so, please follow the steps in Q1)
  2. Plug in your Night Shift device
  3. Click Manage Device
  4. Under Accessory, click Chest Belt
  5. Click Save – the device will turn off and back on again and the device can now be used with the chest belt

Q19: I have been using the Chest Belt but would like to go back to the Neck Strap. How can I do this?

A: In order to use the Neck Strap, the settings on your Night Shift device must first be changed. Follow these directions to change your Night Shift settings:

  1. Open the Night Shift Software (If you have not done so, please follow the steps in Q1)
  2. Plug in your Night Shift device
  3. Click Manage Device
  4. Under Accessory, click Neck Strap
  5. Click Save – the device will turn off and back on again and the device can now be used with the chest belt

Q20: How long or how many days of data does the Night Shift save?

A: The device can store up to 8 nights (7 most recent + base line, if it exists) of detailed daily reports, up to 90-nights of compliance data, and 365 nights of data used for the monthly and yearly reports.

Q21: I just received my Night Shift and I cannot find the retention bands. Where can I find the retention bands?

A: When the strap is packaged, the retention bands are placed over the top of the magnetic ends of the strap.

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C. Night Shift Reports: Solutions for 10 Common Questions

Q22: How can I print or save my reports?

A: The reports open in your computer’s default PDF viewer. Please follow the directions for your PDF viewer to save or print the reports.

Q23: Why are the dates and times on my reports incorrect?

A: If the battery of the device is completely drained for a long period of time, the clock on the device stops which results in the time on the device being incorrect. To fix this, plug the device into the software and update the device’s date and time. Please note, the updated date and time will only affect the newly recorded studies. All past studies will not change.

Q24: On my Daily Report, the number of red lines is not the same number as the value listed for Number of Supine Attempts. Why are these different?

A: Depending on the resolution of your monitor and PDF viewer, the lines that appear on the report may not all appear on your monitor. Also we only present one red line per each 30 second period and if you move on and off your back more than one time in a 30 second period, the number of red lines on the report would be fewer than the Number of Supine Attempts.

Q25: Why do some red lines appear behind other colors while some red lines appear in front of others?

A: The red line indicates you were on your back, whether the line appears in front of or behind another position. The position of the line in front of or behind another position is a result of the resolution of your monitor/printer.

Q26: Why is there blank space on my reports?

A: The report length is rounded up to the nearest hour. Click here for more information about interpreting your Night Shift Report.

Q27: Why are the periods on the Sleep Position chart gray instead of red?

A: When the feedback is turned off, periods where the user is sleeping on their back are marked as gray. Click here for more information about interpreting your Night Shift Report.

Q28: How are Awake periods calculated?

A: The duration and intensity of movement by neck actigraphy is used to determine when the user is asleep or awake. The first ten-minutes of the session are always classified as awake even if the user falls asleep immediately. The height and color of the lines indicate the intensity and duration of the movement that is called awake. Click here for more information about interpreting your Night Shift Report.

Q29: How are Awakenings calculated?

A: An awakening occurs when there is a transition from sleep to wake and then back to sleep. The awakening index is the number of awakenings per hour of sleep time. Click here for more information about interpreting your Night Shift Report.

Q30: How is Sleep Efficiency calculated?

A: Sleep Efficiency is calculated by dividing the total time asleep by the total time the device was turned on. Click here for more information about interpreting your Night Shift Report.

Q31: Why are my reports with the Chest Belt different?

A: The Sleep/Wake algorithm only works correctly when the device is worn on the neck. As such, when the device is worn on the chest, the Sleep/Wake graph and statistics will not appear on the reports. NOTE: Due to the differing location of the microphone, the chest belt snoring data should not be compared to the neck strap snoring data.

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D. Portal Features: Instructions for 6 Potential Issues

Q32: How can I delete the data on my device to start over?

A: NOTE: Clearing study history will remove all recorded information from the device
To clear the study history please open the Night Shift software and follow the steps below:

  • Step 1. Plug in your Night Shift device, open the Night Shift software
  • Step 2. Click Manage Device
  • Step 3. Click Clear Study History
  • Step 4. Click Yes to confirm you would like to clear all data from the device
  • Step 5. The device will vibrate and the study history will be cleared

(Note: If you do not have the Night Shift software, please click here for instructions on downloading the software.)

Q33: I upgraded firmware and now the data on my device is gone. Can it be restored?

A: This can happen if during the upgrade process the device is unplugged before the upgrade is complete. Before the new firmware is loaded onto the device, we save a copy of your data file onto your local computer. To restore the saved file, connect the device to your computer and go to the Night Shift software. When the device is detected, click the Manage Device button and then click F12 on your keyboard. Click the Restore Study Data button and follow the onscreen prompts.

Q34: Does a message appear on the portal website when the site is down for maintenance?

A: A one-week notice is posted on the portal when scheduled maintenance is planned. Scheduled maintenance is generally planned for weekends and during the middle of the night (Pacific Time).

Q35:  I deleted the icon from my desktop but I would like to put it on my desktop now. Is this possible?

A: Please select an operating system and follow the directions to allow the icon to appear on your desktop:

Windows 8

Windows 10

MAC

Windows 8

    1. Open a File Explorer window
    2. Go to the following location on your computer C:\Users\”username” and delete the following two folders
      1. .abm
      2. temp-night-shift-conf
    3. Go to https://nightshifttherapy.com/software-launch/
    4. Click the Night Shift Launcher to open the software
    5. Use the Night Shift software as needed and a new icon will now appear on your desktop

Windows 10

    1. Open a File Explorer window
    2. Go to the following location on your computer C:\Users\”username” and delete the following two folders
      1. .abm
      2. temp-night-shift-conf
    3. Go to https://nightshifttherapy.com/software-launch/
    4. Click the Night Shift Launcher to open the software
    5. Use the Night Shift software as needed and a new icon will now appear on your desktop

MAC

    1. Go to the following location on your computer Macintosh HD > Users > “Username”
    2. Click command + shift + . to show hidden folders
    3. Delete the following two folders
      1. .abm
      2. temp-night-shift-conf
    4. Go to https://nightshifttherapy.com/software-launch/
    5. Click the Night Shift Launcher to open the software
    6. Use the Night Shift software as needed and a new icon will now appear on your desktop

Q37: I would like to delete the Night Shift icon. Is this possible?

A: To delete the icon, just put the icon in your trash folder.

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E. Night Shift Battery and Vibration Test: Confirm Your Device Is Working

Please follow the steps below to test your Night Shift’s battery and vibration motors.

    • Step 1. Plug the device into your computer.
    • Step 2. Device turns on automatically.
        • Step 2a. If the device did not turn on automatically, please use a different cable and plug the device back into the computer.
        • Step 2b. If the device still does not turn on automatically, try using a different USB port or computer.
        • Step 2c. If the device still does not turn on automatically, leave the device plugged in for at least 15 minutes and check to see if the device has turned on by viewing the green light on the device.
    • Step 3. Push the button to turn the device off. One vibration is felt as device turns off.
    • Step 4. After a few seconds, device turns itself on automatically.
    • Step 5. Leave the device charging for 3 hours or until the light on the device turns off and the device is fully charged.
    • Step 6. Now that the device is fully charged, unplug the device from the computer.
    • Step 7. Put the device into “test” mode by holding the on/off button down continuously (about 7-seconds) until the device vibrates.
    • Step 8. If you are using the Neck Strap, with the blue label facing down, place the device on a flat surface. Place two fingers on the black label of the device to feel the vibrations. If you are using the Chest Belt, with the blue label facing up, place the device on a flat surface. Place two fingers on the blue label of the device to feel the vibrations.
    • Step 9. After 30 seconds, the device should begin vibrating. After the first six vibrations, did the intensity increase? Wait another six vibrations, did it increase again? There should seven levels of intensity with six vibrations at each level. Following the six vibrations at the seventh level, the vibration intensity and frequency should begin a random pattern.

If you still believe that your device is not functioning correctly, please email your Night Shift Healthcare provider with your problem and what step of the Battery and Vibration test did not work as expected. The Night Shift device is intended to be operated by the patient, but is not intended to be serviced or maintained by the patient. Servicing and maintenance must be completed by the manufacturer or an authorized distributor. Please contact your Night Shift Healthcare provider if you have any questions.

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F. Night Shift Expected Service Life

The battery, haptic motors, neck strap, and optional chest belt accessory are considered to be replaceable components, and must be replaced during the three year service life of the NS device. The battery has an expected useful life of two years; the user can substantially compromise the useful life by continuously leaving the device on a charger for extended periods when the battery is fully charged. The user can detect when the battery must be replaced; when fully charged, the device is unable to acquire data for >10hours. The haptic motors have an expected service life of 30 hours of vibration. The neck strap and optional chest belt accessory have an expected service life of 6 months when used every day. The expected service life is not a guarantee (see warranty information below).

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G. Night Shift Warranty

Night Shift includes a two-year warranty for assembly workmanship and electronic components, one-year warranty for haptic motors and battery, and six month warranty for neck strap and chest belt. Warranty does not cover damage attributed to improper use by the customer. Night Shift is a medical device that is not water-proof, pet-proof, or mistake-proof. The warranty will be voided if an attempt is made to open the enclosure or change the battery.

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H. Additional Technical Information and Safety Requirements

Environmental Limitations Operation Storage / Transportation*
Temperature / Relative Humidity 5°C to 40°C (41°F to 104°F),
relative humidity 15% to 90%, non-condensin
and water vapor pressure up to 5kPa
-25°C to 5°C (-13oF to 41oF),
5°C to 35°C (41oF to 95oF
with relative humidity up to 90%, non-condensing,
>35°C to 70oC (95°F to 158°F) at water vapor pressure up to 5kPa
Atmospheric Pressure 70 kPa to 106 kPa
20.6 in. Hg to 31.3 in. Hg
70 kPa to 106 kPa
20.6 in. Hg to 31.3 in. Hg

*If device is stored or transported at temperatures < 5°C (41°F) or > 40°C (104°F), the device must be kept at room temperature (20°C / 68°F) for a minimum of 6 hours, or until the device has reached safe operating temperatures (5°C to 40°C / 41°F to 104°F), prior to use.

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I. Night Shift Technical Support

If you have any additional questions, please contact the Night Shift Support team at https://nightshifttherapy.com/support/technical-support/ or by phone at (760)720-0099 ext. 6020. Our Technical Support team is available on weekdays from 8-5PM (Pacific Time). 

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