EDAN F15 Series User Manual page 2

Traditional 510(k) of Fetal & Maternal Monitor
About this Manual
P/N: 01.54.458308
Version: 1.4
MPN: 01.54.458308014
Release Date: Aug. 2020
© Copyright EDAN INSTRUMENTS, INC. 2019-2020. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User's operation failing to
comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC.
(hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials
contained in this manual shall not be photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to confidential information such as
technical information and patent information are contained in this manual, the user shall not disclose
such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or
license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of the
equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons
authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal injury or
death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.
014_14.1_F15_Series_User_Manual
I
2／202