Use Instructions

Instructions for Use – NightOwl
®
Sensor – Healthcare Professional Page 8 of 24
3.4.1 NightOwl
®
Companion app
 Description: iOS and Android smartphone application available for download in the respective
app stores
 Intended User: patients
 Intended Use:
 Links patient with the test provider and test configuration by means of a code or unique link
 Provides patient with instruction for set-up
 Receives data over Bluetooth® Low Energy (BLE) from the NightOwl® Sensor, and sends it to
the NightOwl® Software's cloud environment
 Optional: Push questionnaires to patients
3.4.2 NightOwl
®
Software algorithms
 Description: cloud-based algorithm that generates diagnostic reports based on the data
captured by the NightOwl® Sensor.
 Intended User: Ectosense runs these algorithms on request of healthcare professionals
 Intended Use:
 The NightOwl® Software is intended for physiological signal retrieval, visualisation, report
generation, analysis and interpretation for the area of direct diagnosis and monitoring of
obstructive sleep apnea.
 Claims:
 The NightOwl® Software accurately diagnoses patients with obstructive sleep apnea based
on an analysis of the peripheral arterial tonometry ('PAT'), amongst other channels. It
provides the AHI as well as additional parameters relevant for the diagnosis such as total
sleep time and an indication of cardiac irregularities. It displays photoplethysmography-
derived signals and actigraphy, and (optionally) snoring traces.
 Medical device Class IIa (Europe).
3.4.3 Ectosense Healthcare Professional app
 Description: iOS and Android smartphone application available for download in the respective
app stores
 Intended User: the test provider
 Intended Use:
 Configure offline tests for patients that do not use a smartphone, by linking a patient to a
NightOwl® Sensor.
 Download data stored on the NightOwl® Sensor after usage in which no smartphone was
involved and send it along to the NightOwl® Software algorithms.
3.4.4 Ectosense Dashboard
 Description: browser-based dashboard at dashboard.ectosense.com/nightowl
 Intended User: the test provider