Ectosense NightOwl Manuel utilisateur

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 1of 24

NightOwl®Sensor

Healthcare Professional Manual

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 2of 24

1Document information

These instructions for use were developed exclusively for the healthcare professional

(‘HCP’) and shall not serve to inform patients on their usage of the NightOwl® Sensor.

This labeling information was developed exclusively for the following markets:

Asia-Pacific: Australia, India, New Zealand, Singapore

European Union member states

This labeling information is available in the following languages:

English

French

Consult Commercial Support (see below) if your required language or region is not listed, or if you are not

the intended user of this document.

Store this document for future reference.

2Contacting us

2.1 Technical support

Choose to contact Technical Support over Commercial Support for any questions related to

technical documentation, troubleshooting, or malfunctioning of the sensor.

For support, consider creating a support ticket by contacting us online through

www.ectosense.com/support, even if you have had prior direct contact with an Ectosense representative

through other channels. Contacting Ectosense staff directly through other channels such as email always

results into a longer response time.

For questions regarding a specific sensor, always specify the sensor serial number marked on the sensor

device.

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 3of 24

2.2 Commercial support

Choose to contact Commercial Support over Technical Support for any questions related to

warranty or replacement programs, pricing, or adaptations of documentation according to your

specific clinical pathway.

2.2.1 Product sourced from Ectosense

In case your product was purchased directly from Ectosense, follow the steps outlined under 2.1 Technical

support.

2.2.2 Product sourced from distributors

In case your product was sourced from a distributor, contact your appointed sales or support

representative directly.

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 4of 24

Table of Contents

1Document information 2

2Contacting us 2

2.1 Technical support 2

2.2 Commercial support 3

2.2.1 Product sourced from Ectosense 3

2.2.2 Product sourced from distributors 3

3Introduction 6

3.1 Intended use 6

3.2 Intended use cases 6

3.3 Claims 6

3.4 Connection to the NightOwl®Diagnostic System 7

3.4.1 NightOwl®Companion app 8

3.4.2 NightOwl® Software algorithms 8

3.4.3 Ectosense Healthcare Professional app 8

3.4.4 Ectosense Dashboard 8

3.5 Intended Application 9

3.6 Contra-indications 9

3.6.1 General 9

3.6.2 Clinical 9

3.7 General warnings and precautions 9

3.7.1 Precautions 9

3.7.2 Warnings 10

4NightOwl® Sensor system content 10

4.1 Modes and configurations 11

5Using the NightOwl®Sensor 12

5.1 Turning the sensor on and off 12

5.2 Recording configuration and association 13

5.3 Device set-up 14

5.4 Data retrieval 16

5.5 Charging 16

5.5.1 When is charging required? 16

5.5.2 How to recharge the sensor 17

6Care and maintenance 17

6.1 Cleaning 17

6.2 Disinfecting 18

6.3 Maintenance and servicing 18

6.3.1 Firmware updates 18

7Troubleshooting 19

7.1 Indicator lights under normal usage 19

7.2 Issues 19

8Technical Specifications 21

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8.1 Device and accessories 21

8.2 Disposal 22

8.3 Symbols used on the product labels 23

9Warranty and replacement 23

9.1 Limited Warranty 23

9.2 Outside warranty replacements 24

9.2.1 Lost sensor or charging cradle 24

9.2.2 Loss of other components 24

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 6of 24

3Introduction

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

The recording of the optical blood volume pulse at spectral peak wavelengths of 660nm (red) and

880nm (infrared).

The recording of activity through accelerometry.

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 7of 24

3.4 Connection to the NightOwl®Diagnostic System

Ectosense’s software tools enable the automated analysis to support healthcare professionals in the

diagnosis and monitoring of patients for sleep apnea, as well as provide means to set-up, manage, and

track these patients.

Together, these tools constitute the NightOwl® Diagnostic System. The NightOwl®Sensor can be used as

part of that system, although it is a medical device on its own and available for other uses as well.

The NightOwl® Diagnostic System is further described in its manual which can be found at:

www.ectosense.com/nightowl-documentation

Where throughout this document reference is made to functionalities of other elements of the

NightOwl® Diagnostic System, a blue text box is shown as illustrated below.

For compatibility of the NightOwl®Sensor with the NightOwl® Diagnostic System, ensure that

the sensor is placed on the finger.

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 8of 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® Softwareis 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

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 9of 24

Intended Use:

Initiate testing and configure tests

Inspect status of tests and final diagnostic reports

Optional: Order logistical fulfilment by Ectosense

Admins only: Oversee billing and enrollment of related healthcare professionals into a joint

working unit

3.5 Intended Application

The device is intended to be in contact with non-injured skin at the following body site(s):

The distal phalanges (fingertip)

Body application can last for 15 hours or more and application can be repeated daily.

The sensor is re-usable and is supplied with single-use biocompatible adhesives for attachment of the

sensor to the body site.

3.6 Contra-indications

3.6.1 General

Do not use the sensor on regions of the skin that are tattooed, heavily blemished, or rough.

3.6.2 Clinical

Do not use on individuals in critical care.

Any physical or operating condition that restricts blood flow, such as use of a blood pressure cuff,

may cause an inability to determine high quality photoplethysmografic readings.

Do not use on patients with dyes introduced into their bloodstream, such as methylene blue,

indocyanine green, indigo carmine, or fluorescein.

3.7 General warnings and precautions

The following are general warnings and cautions. Further specific warnings, precautions, and notes

appear next to the relevant instruction in the manual, further accompanied with the cautions symbol.

3.7.1 Precautions

A precaution explains special measures for the safe and effective us of the device.

Do not expose the NightOwl® Sensor to excessive forces, such as caused by fall, shock, or impact.

The power plug is designed to be used within 110-240V AC, 50-60Hz. Check if the required voltage

is available before connecting the adapter to the socket.

Instructions for Use – NightOwl®Sensor – Healthcare Professional Page 10 of 24

Always transport and store the sensor, charging cradle, power plug, or charging cable in the

original packaging to ensure that no damage to the components may arise during transportation

and storage.

The finger wrap for adhesion of the sensor should be disposed of after each use.

3.7.2 Warnings

A warning alerts you to possible injury.

Choking hazard! Keep the device and its accessories away from children.

Do not charge or use the device if it is cracked, damaged or if the internal components are visible.

Do not expose the sensor and accessories to temperatures over +60° Celsius (140° Fahrenheit).

Do not eat, swallow, drop, hit, abuse, open, incinerate, burn or short circuit the sensor, its

accessories, or its components.

Electrical Interference from other devices: The sensor has been designed to work satisfactorily in

the presence of mobile phones, laptops or wireless routers. If the sensor data is not being received

by the qualified app on the mobile device, move a short distance to a new location to remove any

possible influence of another strong radio emitter and then retry the data transfer.

Allergic Reaction: prolonged use may cause an allergic reaction in some users. If an allergic

reaction occurs at the sensor placement site, immediately stop the use.

4NightOwl® Sensor system content

The NightOwl® Sensor system includes:

1. Casing with NightOwl® logo, which contains all the elements listed below;

2. Sensor, containing the Optical Module that emits red and infra-red light (see arrow in the

picture above)

3. Charging cradle (USB-C)

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