FusionHealth AirSense 10 User manual

Run-in night (AirSense 10)
Introduction
This instruction manual explains how to complete a Run-In Night with automatically-titrating continuous
positive airway pressure (aCPAP) in Sleep SMART.
KOEO/FusionHealth Support E-mail
sleepsmarttechsuppor[email protected]
KOEO/FusionHealth Support Phone Number
404-480-5149 extension 4006 (8am-7pm M-F only)
KOEO Login
app.noxhealth.com (Please Use Google Chrome)
Important note about the ResMed full face mask and nasal mask:
The ResMed full face mask and nasal mask used 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" (50 mm) 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.

Brief overview:
A) Standard ResMed masks (see Mask Fitting MOP for more details):
1. Show the participant the three mask types (nasal, nasal pillow, and full face) while the masks
are still in the packaging and ask if the patient has a preference.
2. If the participant has a preference, select that mask.
3. If the participant has no preference, select the nasal mask.
4. Identify the appropriate size, adjust the fit, and test the fit using the mask fit function on the
aCPAP device. Adjust the mask accordingly.
5. If a good fit cannot be achieved, select an alternative mask and repeat these procedures.
6. Help participant practice placing and removing mask many times until participant facile with it.
7. Use the fitted mask for the 15-20-minute daytime trial prior to the run-in night. Make
adjustments to optimize comfort.
B) DreamWear masks (see DreamWear mask MOP for more details):
1. Fit all subjects with the DreamWear nasal mask with under-the-nose cushion.
2. Check the mask fit using the aCPAP mask fit function. Adjust the mask accordingly.
3. If a subject cannot use the nasal mask (e.g. uncomfortable, difficulty breathing through nose
because of nasal congestion), please visually show the subject both the DreamWear full face
mask and DreamWear nasal pillows, and have him/her select the preferred style. If the subject
has no preference, try the full face mask next. The full face mask contains magnets, so do not
select if this is contraindicated. Use the aCPAP mask fit function to confirm fit. Make
adjustments accordingly.
4. Help participant practice placing and removing mask many times until participant facile with it.
5. Use the fitted mask for the 15-20-minute daytime trial prior to the run-in night. Make
adjustments to optimize comfort.
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.
1.Subject Eligible Task
Click on the Subject Eligible task in KOEO, and the following appears:
Do not use the ResMed 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

Once the mask fitting is complete, indicate the Mask Size and Mask Fit for the mask selected as noted
above in the Subject Eligible Task.
If a DreamWear mask was selected, please indicate the size and fit in rows 7 and 8 above.
Additionally, please select the corresponding ResMed mask style (full face, nasal pillow, or nasal) to
indicate which DreamWear style was selected. For example, fill out the AirFit F20 Full Face if the
DreamWear Full Face was selected.
Click submit when done.
This will record the mask or masks that were selected for the Run-In Night.
The next Task to appear in KOEO is APAP Night 1.
NO FURTHER ACTION is required in KOEO for the Run-In Night.
The APAP Night 1 task is to be completed after the Run-In Night is finished.

2. Setting Up the aCPAP Unit
4

3. Filling the Water Tub
4.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.

Now that supplies are set:
1. Make sure the power is connected.
●Adjust the humidification level, if required.
●Fit the mask as described in the mask user guide.
●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.
●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.
●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.
2. Have the participant try to use CPAP for 15-20 minutes prior to the run-in night.
•Have the participant use CPAP sometime before bed. If possible, the participant should be lying
down and doing a relaxing activity such as reading or watching TV.
•This gives the participant the opportunity to acclimate a bit to CPAP
•It also allows an opportunity for mask adjustments before the participant is trying to sleep at
night.
3. Using PAP at Bedtime
●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 a
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.
4.The SmartStart Feature
The aCPAP S10 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. Please note that if the device
is turned on via the SmartStart (the subject starts to breathe through the mask), and study staff then
push the start/stop button, the device will then be in the off mode.
5. 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.
●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. 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.
6. 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 CPAP 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.
7. 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. The subject is also
welcome to retry the Run-In night if use was <4.0 hours, CAI was <10, and they express interest in
trying again.

8. Determining if Subject is Eligible from the AirSense 10
●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.
9. 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.
Prior to each run-in night, the run-in night CPAP device will need to be configured to display 1 Day in
the “Period.” The middle image above displays 1 Month (the default setting). 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.
To do this, you will access the Sleep Report (from the home screen, use the dial to highlight and then
select Sleep Report).
•Rotate the dial until “Period” is highlighted
•Press the dial to select “Period.”
•Rotate the dial to highlight “1 Day”
•Press the dial to select “1 Day”

** Again, remember to reset the “Period” to 1 day prior to each run-in night. **
Note: For this reason, an aCPAP unit should never be used for more than one subject’s Run-In Night
within any 24-hour period. The 24-hour period starts at noon and ends at 11:59 AM the next day.
Therefore, do not start a daytime study before noon because there will not be enough time to conduct the
Run-In session.
10. 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?
●Repeat run-in night: If Usage Hours were < 4 hours, and CAI was <10, and the subject
would like to repeat the run-in night, it may be repeated. If 4 hours were not achieved due
to an external interruption, then it can be repeated twice.
●To be eligible for randomization, the subject must be willing to continue with randomization
knowing that he/she has a 50% chance of being assigned to use CPAP and 50% chance of
being assigned to no CPAP for the next 6 months.
11. 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. (If the subject will repeat the run-in night please use the same
supplies for the second run-in night.)
If the subject is randomized to the treatment (CPAP) group, remove the tubing and humidifier basin
and, along with the mask tried, provide to the subjects.
Each NEW subject’s run-in night should involve a brand new mask, tubing, and humidifier
basin.
12. 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
13. 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 hours) and the aCPAP device-generated Central Apnea Index (Central AI must be <10), and the
subject’s willingness to continue, as previously discussed.
14. 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.
15. APAP Tasks: if Outcome is “Not Eligible”
If the Run-In Night does NOT have to be repeated, but the subject could not utilize the aCPAP device
for ≥4 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
16. APAP Tasks: Outcome is “Eligible”
If the Run-In Night does NOT have to be repeated, and the subject used PAP ≥4 hours, central AI was
<10, and the subject is willing to be randomized, the subject is eligible for randomization.
●Click on Eligible for randomization
●Click Submit
17. 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:

18. Intervention Group
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. (Remember to show the care management
video, introduce myAir and Tess the chatbot, and offer to assist the subject with myAir registration and
initial chatbot texting.) 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 sleep coaches.
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 the erroneous
data.
●Enter Demographic Information. PLEASE PROVIDE AS MUCH CONTACT INFORMATION AS
YOU HAVE AVAILABLE IN THE CONSENT.

●If a DreamWear mask was dispensed, under Special Instructions, please indicate what type of
DreamWear mask the subject is going home with. For example, “DreamWear Full Face” or
“DreamWear Nasal.”
●Click the Save Icon in right hand corner when complete
19. 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. Please double check to
make sure you accurately entered these data.
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 best fitting mask 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 about the mask that worked best on the Run-In Night, the same
mask that the subject will keep to continue using with aCPAP. Record the following as noted above:
●Enter first mask detail:
○Select the type (in example, DreamWear Mask (type cannot be specified) is chosen)
○Select the size (in example, Medium is chosen)
●When finished, Click Submit
Recording this information is important because it lets FusionHealth know what equipment the subject
has 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.
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).
1 2
3
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.

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
Detergent Water Temperature
Alconox (1% dilution) 70-140⁰F
Gigazyme (1% dilution 113-140⁰F
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.
Disinfectant Time in Bath
CIDEX OPA (0.55%) 12 minutes
Gigasept FF (5%) 15 minutes
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
Sleep SMART does not limit any other cleaning procedures
dictated by local institutional policies