Introduction; Intended Use; Intended Use Cases; Claims - Ectosense NightOwl Healthcare Professional Manual

3 Introduction

The NightOwl® Sensor is a wireless device designed for comfortable, continuous data recording during an
individual's sleep.
The device records two signals:
 Dual-wavelength photoplethysmography ("PPG"), from which oxygen saturation, peripheral arterial
tone (PAT), and pulse rate channels can be derived.
 3-axis accelerometry to capture motion-based activity from which total sleep time ("TST") and body
position can be derived (depending on the sensor's placement).
The NightOwl® Sensor was supplied to you either as a stand-alone device or as part of a system for the
diagnosis and monitoring of sleep apnea which further consists of several separate software devices,
together referred to as the NightOwl® Diagnostic System as elaborated in 3.4 Connection to the
NightOwl® Diagnostic System below.

3.1 Intended use

The NightOwl® Sensor is intended to be used for the continuous recording of a patient's pulse waveform
(also known as photoplethysmography, or 'PPG') and motion during sleep or resting, in both the clinical
and the home environment.
The sensor can be worn on the finger, by adults or children aged 13 and over, without requiring direct
supervision of a healthcare provider.

3.2 Intended use cases

1. The patient is provided with the NightOwl® Sensor by a healthcare professional who wishes to
perform a recording of the patient's signals in the home environment as part of a disease
management plan, such as with the NightOwl ®Diagnostic System, or,
2. An individual wishes to add the sensor data to a recording package for sleep patterns and sleep
disturbances.

3.3 Claims

# Claim
1 The recording of the optical blood volume pulse at spectral peak wavelengths of 660nm (red) and
880nm (infrared).
2 The recording of activity through accelerometry.
Instructions for Use – NightOwl ® Sensor – Healthcare Professional Page 6 of 24