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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
sleepsmarttechsupport@noxhealth.com
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.
Run-in night (AirSense 10)
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Summary of Contents for FusionHealth AirSense 10
- Page 1 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...
- Page 2 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 Brief overview: A) Standard ResMed masks (see Mask Fitting MOP for more details): 1.
- Page 3 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.
- Page 4 2. Setting Up the aCPAP Unit...
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Page 5: Filling The Water Tub
3. Filling the Water Tub 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. - Page 6 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.
- Page 7 ● 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.
- Page 8 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.
- Page 9 ** 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.
- Page 10 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.
- Page 11 ● 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. ●...
- Page 12 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...
- Page 13 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.
- Page 14 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...
- Page 15 ● 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.
- Page 16 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: ●...
- Page 17 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).
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