FusionHealth aCPAP Components Sleep Smart Care User Manual

FusionHealth aCPAP Components Sleep Smart Care

Introduction

This instruction manual explains how to complete a Run-In Night with automatically-titrating continuous positive airway pressure (aCPAP) in Sleep SMART.

• KOEO Support Phone Number
  404-480-5149 extension 4006

• KOEO Support E-mail
  sleepsmarttechsupport@noxhealth.com

• KOEO Login
  app.noxhealth.com ​(Please Use Google Chrome)

app.noxhealth.com (Please Use Google Chrome)

Important note about the full face mask and nasal mask:
The full face mask and nasal mask used in Sleep SMART include magnets . Per the manufacturer’s specifications, the magnets used in this mask are within ICNIRP guidelines for general public use. However, please ensure the headgear and frame are kept at least 2″ (50mm) away from any active medical implant (eg, pacemaker or defibrillator) to avoid possible effects from localized magnetic fields. The magnetic field strength is less than 400 mT. Do not use these masks if the subject has a metallic hemostatic clip implanted in the subject’s head to repair an aneurysm, or has metallic splinters in one or both eyes following a penetrating eye injury. (During the Sleep SMART aCPAP run-in night, the nasal pillows mask (ResMed P10) can be used as it has no magnets). Alternative nasal and full face masks without magnets will be available from FusionHealth after discharge to subjects randomized to the aCPAP group.
As noted elsewhere, additionally do not use a full face mask if: decreased mental status; is on tube feeds; or is unable to remove the mask without assistance.

Do not use a full face or nasal mask if:

1. A metallic hemostatic clip implanted in subject’s head to repair an aneurysm
2. Metallic splinters in one or both eyes following a penetrating eye injury

If the “​Subject Eligible”​ task appears in KOEO, this means the subject IS eligible for the Run-In Night in Sleep SMART. The ​Subject Eligible​ task is the first step in the Sleep SMART KOEO Process that applies to the Run-In Night.

Subject Eligible Task
Click on the ​Subject Eligible​ task in KOEO, and the following appears :

A descriptive text indicates the T3 study showed OSA that qualifies the subject to continue. Please perform mask fit and answer mask questions.
Start the mask fitting process by showing the subject an example of each mask type (nasal pillows, nasal and full face). If the patient indicates a preference for a particular mask type, start the fitting process with that style of mask, per the instructional video provided. If no preference is indicated, start by fitting a ​nasal mask​ using the appropriate template and as noted in the instructional video. Once the nasal mask fitting is complete, indicate the ​Mask Size​ and ​Mask Fit for the nasal mask as noted above in the ​Subject Eligible Task​.
Next, using the appropriate template, fit the subject for a full face mask, unless it is contraindicated. Once the full face mask fitting is complete, indicate the ​Mask Size​ and ​Mask Fit for the full face mask as noted above in the ​Subject Eligible Task​. Next, proceed to fitting a nasal pillows mask​ .

Since there is no nasal pillows template, you will need to fit this style of mask visually and by trial and error as indicated in the instructional video.
If a nasal pillows mask is fitted, indicate the ​Mask Size​ and ​Mask Fit​ for the nasal pillows mask as noted above in the ​Subject Eligible Task​. If no nasal pillows mask is fitted, leave the ​Mask Size​ and ​Mask Fit ​ sections blank (lines 5 and 6). If the subject chooses the nasal pillow mask as their preferred mask at the beginning of the fitting process, and the nasal pillows is a “best fit”, be sure to ​at least indicate the proper Mask Size​ for the nasal and full face masks using the appropriate templates.

• Mask Size for AirFit F20 (Small, Medium, or Large) ​Line 1
• Mask Fit for AirFit F20 (Best, Good, or Poor) ​Line 2
• Mask Size for AirFit N20 (Small, Medium, or Large) ​Line 3
• Mask Fit for AirFit N20 (Best, Good, or Poor)​ Line 4
• Pillow Size for AirFit P10 (Small, Medium, or Large) ​Line 5
• Pillow Fit for AirFit P10 (Best, Good, or Poor)​ Line 6
• Click Submit​ (Arrow)

This will record the mask or masks that were best for the Run-In Night. By the end of the mask fitting process, information should generally be entered for all three “starter mask” types (except for the full face mask if it is contraindicated). This will mean using one nasal pillow mask to do the fitting, and use at least the mask fitting templates (if not the masks themselves) for the nasal and full face masks. The next Task to appear in KOEO is ​APAP Night 1​.
NO FURTHER ACTION​ is required at this point in KOEO for the Run-In Night .

The ​APAP Night 1​ task is to be completed in KOEO ​AFTER​ the Run-In Night is finished.
Next, you will learn the steps needed to Set Up and Run the aCPAP device, apply the different Sleep SMART aCPAP masks, and provide education regarding aCPAP therapy. In addition, you will learn how to interrogate the aCPAP device at the end of the Run-In Night in order to determine whether the subject is eligible for randomization.

Setting Up the aCPAP Unit

Follow instructions outlined in the SleepSMART – MOP – aCPAP and SleepSMART – MOP – Mask Fitting. Change the filter in the run-in night aCPAP device once per month.

CAUTION
Do not overfill the water tub as water may enter the device and air tubing

1. Place the device on a stable level surface.
2. Plug the power connector into the rear of the device. Connect one end of the power cord into the power supply unit and the other end into the power outlet.
3. Connect the air tubing firmly to the air outlet located on the rear of the device.
4. Open the water tub and fill it with distilled water up to the maximum water level mark. Do not fill the water tub with hot water.
5. Close the water tub and insert it into the side of the device.
6. Connect the free end of the air tubing firmly onto the assembled mask. See the mask user guide for detailed information.
   Recommended masks are available on www.resmed.com.

Filling the Water Tub

1. Remove the water tub.
2. Fill the water tub with distilled or deionized water up to the maximum water level.
3. Close the water tub and insert it into the side of the device.

Setting Up the ClimateLine Air Tubing

1. Align the ClimateLine Air tubing with the ClimateLine Air connection port. Push the ClimateLine tubing firmly onto the air outlet.
2. Connect the assembled mask system to the free end of the ClimateLine air tubing.

Getting Started

1. Make sure the power is connected.
2. Adjust the humidification level, if required. A typical starting point for tubing temperature would be 81 degrees, and a typical starting setting for humidification would be 4.
3. Adjust the mask as described in the mask user guide.
4. To start therapy, press the Start/Stop button or simply have the subject breathe into the mask. The Smart Start function will turn on the device. The green light indicates the device is off, and the blue light indicates it is on.
5. Have the subject lie down and arrange the air tubing so that it is free to move if he or she turns during their sleep.
6. To stop treatment at any time, press the Start/Stop button and remove the mask, or simply remove the mask. The SmartStop function will turn off the device.

Using PAP at Bedtime

• Always fill the water tub with distilled water only.
• Put on the mask and start the device. Remember that the device will increase flow if it senses leak.
• Place the tubing above the headboard or between the pillow and the wall. Bringing it over the pillow in this manner may help keep it out of the way during sleep.

The SmartStart Feature
The aCPAP device has a comfort feature called SmartStart / SmartStop that is enabled. This feature will start the device automatically when the subject breathes into the mask and then stop the device automatically when the subject removes the mask. If a subject does not like the SmartStart feature, it can be disabled by contacting the Sleep SMART Care Team.

Restarting PAP during the Sleep Cycle

• If it is necessary to interrupt use of PAP (to use the restroom, for example), stop the device as noted above.
• Subjects can either disconnect the tubing at the mask, and keep just the mask on, or take the mask off and then put it back on when they come back to bed. We favor the former approach. Subjects should NOT ambulate with the mask on and the tubing still connected to the mask, but not to the aCPAP unit.
• When they return to bed, they should reassemble the connection or reapply the mask and push Start/Stop again or simply breathe into the mask. The device will restart using the same lower pressure it likely started with at the beginning of the night. As before, the machine will gradually ramp up the pressure until it reaches the targeted range.
• If subjects wake up in the middle of the night and the mask is to the side of the face, off of their face, or off the bed, just put it back on and encourage them to return to sleep. People sometimes remove their PAP masks while they are asleep during the first few weeks of acclimation to treatment.
• The RT (or sleep tech) should check on the subject during the night to help troubleshoot any issues.

When They Wake Up

• Turn off the aCPAP unit by pushing the Start/Stop button on the device or by simply removing the mask. This will also turn off the humidifier.
• Disconnect the hose and take the water out. Be careful with the humidifier because the heating element may be hot.
• Clean the hose and water tub if the subject is randomized to the aCPAP intervention arm of Sleep SMART.
• For those who are not randomized to aCPAP intervention arm, discard the tub and hose.
• If they notice a small amount of flow coming from the device after turning it off, this is the system cooling off the humidifier. This is normal and automatically stops after 20 minutes.

Run-In Night Considerations
Per the Sleep SMART Protocol, aCPAP will be used on one night to determine tolerability. Subjects who use the device​ ≥4 hours​ on that night, who do not have excessive
treatment-emergent Central Sleep Apnea (CSA), ​and​ are willing to continue to randomization will be randomized to receive either 6 months of aCPAP (intervention group), or 6 months of standard clinical practice (non- intervention group). Absence of excessive treatment-emergent CSA for Sleep SMART is defined by a ​Central Apnea Index less than 10 events/hr, based on aCPAP device-generated data from the Run-In Night.
After the Run-In Night, the device is interrogated manually in order to read the aCPAP device-generated data on hours of usage, the Central Apnea Index, and other variables (see below).
If the aCPAP Run-In Night is interrupted or otherwise limited by required clinical care, and for this reason does not meet the ≥4 hours criterion, testing should be repeated, if possible.

Usage and Efficacy Data from the ResMed AirSense 10 AutoSet

• To check the usage and efficacy data on the aCPAP, click on the “Home Icon” button at the bottom of the display.
• Using the dial to the right of the display, scroll to Sleep Report.
• Press the dial button.
• Use the dial to scroll through the Usage and Efficacy Data visible in the Sleep Report.

Viewing the Sleep Report
The Sleep Report screen shows sleep quality and mask seal status for the most recent therapy session. To view additional usage data, use the dial to scroll down in the Sleep Report.

The devices used for the Run-In Night in Sleep SMART will be configured to display ​1 Day​ in the “Period”. The middle image above displays 1 Month. These values may be edited, but for the Run-In Night in SleepSMART the device must be set to ​1 Day​ as this represents the data that were just acquired for this individual subject during the Run-In Night. Note: for this reason, a given aCPAP unit should never be used for more than one subject’s Run-In Night within the 24-hour period that runs from noon to 11:59 AM the next day. Therefore, do not start a daytime run-in before noon because there will not be enough time to conduct the Run-In session.

Outcome of Run-In Night
Following the Run-In Night, the site coordinator must determine the next step for the subject. Upon interrogating the Sleep Report on the aCPAP, the following criteria must be assessed:

• Were the Usage Hours​ ≥ 4.0 hours​?
• Was the ​Central AI below 10/hr​ on aCPAP device-generated data?
• If Usage Hours were < 4 hours, was the Run-In Night aCPAP session interrupted and/or limited by clinical care (and therefore eligible for repetition)?
• Is the subject willing, if eligible, to continue with randomization?

A Run-In Night aCPAP session may be repeated up to two (2) times, but ONLY if the session was interrupted by clinical care demands or other external sources.

Equipment after Run-In Night
If the subject fails the run-in night and it will not be repeated, or is randomized to the Control (no CPAP) group, remove the tubing and humidifier basin from the aCPAP device and discard them along with any masks that have been tried or used. (Sites may donate the equipment, send for appropriate cleaning and reuse in their sleep laboratories or provide to RTs if desired and in keeping with the relevant institutional policies and regulations).
If the subject is randomized to the treatment (CPAP) group, remove the tubing and humidifier basin and, along with the masks tried, provide to the subjects.
Each subject’s run-in night should involve brand new masks, tubing, and humidifier basin.

WebDCU:
After the final Run-in Night, the following data (except for date) are read off the aCPAP display, and entered into WebDCU

• Date (date the run-in night was started)
• Used hrs (usage hours)
• Pressure
• Leak
• AHI
• Central AI

APAP Night 1 Task in KOEO

Upon completion of the Run-In Night, the site coordinator must answer the question in the APAP Night 1​ task, about whether to ​Retry the Run-In Night​ : “Yes” or “No”.
If NO, then the site coordinator must also select whether the subject is ​Eligible for randomization​ or ​Not eligible for randomization​ . The determination at this point is based upon the usage hours (must be ≥ 4.0 hours) and the aCPAP device-generated Central Apnea Index (Central AI must be <10), and the subject’s willingness to continue, as previously discussed.

APAP Tasks

If ​YES​ is Selected to “Retry Run-In Night’

• If the Run-In Night is to be repeated, click “YES”
• Click Submit in the right hand corner

Next, the ​APAP Night 2​ task will appear in the KOEO Task List. It will NOT be necessary to repeat the ​Subject Eligible​ task in KOEO where masks are fitted and sized, and quality of fit is assessed..

If Outcome is “Not Eligible”
If Run-In Night does NOT have to be repeated, but the subject could not utilize the aCPAP device for ​≥ 4.0 hours​, the CAI was ​≥ 10​, or the subject is unwilling to continue with Sleep SMART, the subject is Not eligible for randomization

• Click on ​Not eligible for randomization
• Click Submit

If the Run-In Night is NOT to be repeated and the subject is NOT eligible for randomization, the Excluded – Print Report ​Task will appear. This will end the Sleep SMART process for the subject.

Outcome is “Eligible”
If Run-In Night does NOT have to be repeated, and the subject tolerated PAP ​≥4 hours​, Central AI was <10, and the subject is willing to continue, the subject is eligible for randomization.

• Click on ​Eligible for randomization
• Click Submit

Treatment Assignment Task in KOEO
Following the aCPAP Run-In Night, subjects deemed ​Eligible​ are randomized centrally on the WebDCU website (https://webdcu.musc.edu/login.asp) to either the Intervention Group or Control Group (non-intervention group) in a 1:1 ratio with an algorithm developed by the National Data Management Center (NDMC).
Site coordinators must access information from WebDCU regarding treatment assignment of the subjects to either the Intervention Group or to the Control Group.
Once randomization is completed by WebDCU, the site coordinators must complete the Treatment Assignment​ task in KOEO by first clicking on the ​Treatment Assignment ​ task:

If a subject is randomized to the Intervention Group (aCPAP), he or she will receive aCPAP equipment and will be enrolled into Sleep SMART Care Management. Select the appropriate Treatment Group for the subject and click Submit:

If randomized to the control (no CPAP) group: No further information needs to be entered into KOEO and the subject has no contact with FusionHealth.
If randomized to the intervention (CPAP) group: After submitting the subject’s treatment assignment in KOEO, the next task is to ​Enter Patient Info​:

The following subject demographics are entered into KOEO:

• Name
• Date of Birth
• Address
• Telephone Number
• Best Call Times
• Patient Time Zone
• Gender
• Marital Status
• Special Instructions, if any

This information is critical for subsequent Care Management by the Sleep SMART Care Team. Please be sure that this information is valid and entered accurately in the appropriate fields. If you have any doubts regarding the information requested, please double check before entering erroneous data.

• Enter Demographic Information
• Click the Save Icon in right hand corner when complete

Dispensing aCPAP Equipment
After the demographic information has been entered in the ​Edit Patient Info​ task, the Dispensing Questions​ task will appear. Click on the ​Dispensing Questions​ task:

Subjects randomized to the Intervention Group in Sleep SMART will be issued new aCPAP equipment that has been provided by FusionHealth and kept in stock on site.

PLEASE DO NOT SEND A SUBJECT HOME WITH THE RUN-IN NIGHT DEVICE. The site coordinators must enter both the​ ​ 11-digit serial number​ ​and the ​3-digit device number​ of the aCPAP into KOEO for the successful transmission of treatment usage and efficacy data throughout Sleep SMART.
The serial number and device number are located on the outside of the aCPAP box, as well as on the back of the aCPAP device itself (as highlighted by the “red boxes” on the images below).

• Enter the ​11-digit serial number​ of the aCPAP device at the top
• On the next line, enter the ​3-digit device number​ of the aCPAP device

Subjects in Sleep SMART are eligible to receive the two (2) best fitting masks from the Run-In Night. Based on the best mask TYPE and FIT from the Mask fitting session prior to the Run-In Night, and based on the subject’s preference, enter the details regarding the two (2) masks that will be issued to the subject following the Run-In Night. ​Note, the two (2) masks issued may be the same or different TYPE of aCPAP masks.
Record the following as noted above:

• Enter first mask detail:
  • Select the type (in example, ​AirFit F20 Full Face Mask​ is chosen)
  • Select the size (in example, ​Medium​ is chosen – ​Red Arrow​)
• Enter second mask detail:
  • Select the type (in example, ​AirFit N20 Nasal Mask​ is chosen)
  • Select the size (in example, ​Medium​ is chosen – ​Red Arrow​)
• When finished, Click Submit

Recording this information is important because it lets FusionHealth know what equipment the subject has, what new unused mask (a duplicate of the first mask) will be included in the package of the new equipment given to the subject, and also what equipment needs to be resupplied to the site.
After clicking “submit”, the Sleep SMART KOEO Process for the on-site team is complete.
For those subjects randomized to the aCPAP intervention arm, please note that the Sleep SMART Care Team will manage all sleep apnea care after discharge from the hospital. No additional data entry in KOEO will be required from the sites or the site coordinators following the ​Dispensing Questions​ task in KOEO.

Cleaning the aCPAP Device for Use With Additional Run-In Subjects
After the Run-In night, the following components of the aCPAP Device should be discarded if the subject is ​ineligible for randomization or randomization to the control group​, or given to the subject if the subject is ​randomized to the aCPAP group​:

• Water basin
• Air Tubing
• Masks tried

Before the Run-In Night aCPAP device can be reused with another subject, you should clean any soiled external surfaces of the aCPAP device with a disinfectant wipe or other routine disinfectant (Sleep SMART does not limit any other cleaning dictated by local policies). In the event of​ possible contamination of the humidifier basin, mask or tubing​ , and to minimize risk of contamination due to the COVID-19 virus, the ​Air Outlet ​should be removed, decontaminated, disinfected, and replaced into the aCPAP device.
To minimize risk of contamination of COVID-19, it is suggested to remove, decontaminate, disinfect, and replace the Air Outlet of the aCPAP prior to next use.

Removing the Air Outlet

1. Locate the Air Outlet on the inside of the device
2. Release the Air Outlet by pressing the clip located inside the device
3. Remove the Air Outlet by pulling it out through the air outlet socket at the rear of the device (You may need to gently wiggle it while pulling it through the air outlet socket).

Note: Sleep SMART does not limit any other cleaning procedures dictated by local institutional policies

Decontaminating the Air Outlet
Before the disinfection process, clean and rinse the air outlet so that no visible contaminant is present as follows:

• Clean the Air Outlet with a soft bristle brush for 1 minute while soaking in a detergent solution (see table below for examples). Pay particular attention to all crevices and cavities.
• Thoroughly rinse the Air Outlet according to manufacturer’s instructions

Disinfecting the Air Outlet
Using a chemical disinfectant (see table below), soak the Air Outlet for the indicated amount of time. Thoroughly rinse by immersing it completely in clean water for a minimum of 1 minute. Repeat the rinsing procedure a total of 3 times. Air dry away from direct sunlight and/or heat.

Reassembling the Air Outlet

1. Hold the Air Outlet with the seal pointing to the left and the clip pointing forward
2. Make sure that the Air Outlet is correctly aligned and insert the Air Outlet into the socket. It will click in place (You may need to gently wiggle it while pushing it through the air outlet socket).
3. Check if the Air Outlet is inserted correctly as shown

References

• Login

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>