Fitbit Flow Handleiding


Lees hieronder de 📖 handleiding in het Nederlandse voor Fitbit Flow (59 pagina's) in de categorie Niet gecategoriseerd. Deze handleiding was nuttig voor 328 personen en werd door 2 gebruikers gemiddeld met 4.5 sterren beoordeeld

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Fitbit Flow User Manual
Version A
129-0575-01
May 2020
WARNING
The Fitbit Flow has not been FDA cleared or approved;
The Fitbit Flow has been authorized by FDA under an EUA;
The Fitbit Flow is authorized only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency use of
ventilators under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.
Due to the rapid development cycle for this emergency use device, all efforts were made to
verify the software, but defects may still exist. The consequences of these defects are unknown
and may pose a risk to the patient.
For use only while FDA’s Emergency Use Authorization is in effect.
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Table of Contents
Glossary 6
Purpose of this manual 9
Safety Information 9
Definitions 9
General Warning Statements 9
Symbols and Markings 12
Fitbit Flow Overview 14
Indications for Use 14
Target Patients 14
Target Environment 14
Operational Use 14
Breathing Circuit 16
Respiratory Parameter Controls 17
Safety Features 17
Compatible Manual Ventilator 18
Tubing, Sensors, and Valves (outside enclosure) 18
Tubing, Sensors, and Valves (inside enclosure) 18
Risks and Benefits 19
Device Description 20
User Interface 20
Controls, Indicators, and Displays 20
Front Panel 22
Back Panel 23
Left Panel 24
Right Panel 25
For use only while FDA’s Emergency Use Authorization is in effect.
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Product specificaties

Merk: Fitbit
Categorie: Niet gecategoriseerd
Model: Flow

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