Use Instructions

Instructions for Use – NightOwl
®
Sensor – Healthcare Professional Page 4 of 24
Table of Contents
1 Document information 2
2 Contacting 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
3 Introduction 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
4 NightOwl® Sensor system content 10
4.1 Modes and configurations 11
5 Using 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
6 Care and maintenance 17
6.1 Cleaning 17
6.2 Disinfecting 18
6.3 Maintenance and servicing 18
6.3.1 Firmware updates 18
7 Troubleshooting 19
7.1 Indicator lights under normal usage 19
7.2 Issues 19
8 Technical Specifications 21