Intended Application; Contra-Indications; General; Clinical - Ectosense NightOwl Healthcare Professional Manual

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 9 of 24