Support - Downloads

1 NightOwl Product Manuals

The NightOwl Diagnostic Testing System consists of different hardware and software devices:

  • The NightOwl Sensor: registers raw sensor data when applied to a patient for an overnight recording
  • The NightOwl Companion smartphone app: provides instructions to the patient for self set-up and sends recorded data over to the cloud for analysis
  • The NightOwl Software: analyses the recorded data to provide diagnostic insights
  • The Ectosense Dashboard: allows the healthcare professional to view diagnostic results as well as configure patient tests in a browser-based portal - visit dashboard.ectosense.com/nightowl
  • The Ectosense Healthcare Professional smartphone app - used by healthcare professionals that wish to use the NightOwl Sensor without requiring patients to use their smartphone (the sensor's Offline Mode)

1.1 NightOwl Diagnostic Testing System Manual

This manual intended for the healthcare professional describes how all the dashboards, apps, and sensor work together to provide a configurable patient flow.

EN

1.2 NightOwl Sensor Instructions For Use

This instructions for use document for the healthcare professional describes the NightOwl Sensor, as well as its possible uses within or outside the NightOwl Diagnostic Testing System.

ENFR

1.3 NightOwl Software Instructions For Use

This instructions for use document for the healthcare professional describes the NightOwl Software - the analytical engine that turns data from the NightOwl Sensor into a report for aid in the diagnosis of slee apnea.

ENFRPT

2 NightOwl Supplementary Information

The below files help healthcare professionals in choosing a configuration of the NightOwl to match their patient flows as well as provides instructions to patients.

2.1 Step-by-Step instructions

These step-by-step instructions are to be provided to the patient.

Instructions for the 'Streaming Mode' (when patients are required to connect to the sensor with their smartphone) can each contain a (QR) activation code that can be custom to your unit in the Ectosense Dashboard. Contact commercial support if wish to make use of this functionality and have not been provided with these papers yet. 

Note that if you have configured a patient in the Ectosense Dashboard using the patient's email address, the patient will have received nearly identical instructions over email and provision of further step-by-step instructions is not required.

2.1.1 Streaming Mode - Non-Fulfilment

Use these instructions when you have patients use their smartphone and when you provide the NightOwl Sensor directly to the patient.

ENFRNLPT
2.1.1.1 Pharmacy variation

Use these step-by-step instructions when the patient is provided the NightOwl Sensor by the pharmacist and needs to return it to this pharmacist upon the end of a      recording.

FR
2.1.2 Streaming Mode - Fulfiment

Use these instructions when you have patients use their smartphone and when you rely on a logistics provider to mail your patient the NightOwl Sensor device. 

ENFRNLPT

2.1.3 Offline Mode - Non-Fulfilment
ENFRNLPT


3 Regulatory

3.1 Quality system certificates

Ectosense maintains a quality system for medical devices and is audited by SGS Belgium.

ISO 13485:2016

3.2 Product certificates

EU NightOwl Software

3.3 Product declarations

NightOwl Sensor EC DoCNightOwl Software EC DoC

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