Instructions for Use Evone
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1 Safety
1.1 Introduction
Thank you for choosing Evone. This Instruction for Use accompanies Evone and is intended for
users who operate Evone. Users must be trained.
Always read the Instructions for Use before use!
Refer to the website https://www.ventinovamedical.com/products/evone for further
information and training materials related to this product.
Ventinova Medical B.V. makes no claim for use of the product other than the intended use
specified herein and disclaims any liability resulting from other uses. Observe all warnings,
cautions and notes.
1.2 Intended Use
Evone is a mechanical ventilator intended to be used for ventilation of patients requiring FCV
®
or jet ventilation modes.
Evone is intended to be used in elective procedures for less than 72 hours without the need to
use inhaled anesthetic agents.
1.3 Operator
Evone is intended to be used by or under direct and undivided supervision of an anesthesiologist
or intensivist in all settings.
For safe and effective use of the device, device specific training is required.
1.4 Patient Group
All patients >40 kg IBW
Warning: The body weight limit is based on ideal body weight. Do not use Evone with
obese children with a body weight of less than 60 kg. Risk on barotrauma.
1.5 Use Environment
Evone is intended to be used in operating rooms and ICU environments in hospitals.
Warning: Correct functioning of Evone may be adversely affected by the operation
of other equipment, such as high frequency electro-surgery equipment, short-wave
therapy equipment, defibrillators, or MRI equipment. Risk on malfunction.
