Introduction To Sonalleve Mr-Hifu; About Sonalleve Mr-Hifu; About This Manual - Profound Sonalleve MR-HIFU Instructions For Use Manual

Table of Contents

1. Introduction to Sonalleve MR-HIFU > 1.1. About Sonalleve MR-HIFU

1. Introduction to Sonalleve MR-

The Sonalleve MR guided High Intensity Focused Ultrasound (MR-HIFU) System has the following

therapeutic application:

MR guided treatment of desmoids

Sonalleve MR-HIFU is designed to be used with Philips MR scanners.

The use of MR-HIFU requires the following equipment:

Achieva 1.5 T/3.0 T or Ingenia 1.5 T/3.0 T MR scanner.

Sonalleve MR-HIFU system.

This manual will guide you in the use of the Sonalleve MR-HIFU system. In addition, all the

instructions and safety precautions for the MR scanner apply when working with the Sonalleve MR-

HIFU system. For more information, refer to the MR scanner's Instructions for Use.

This manual applies to the following MR-HIFU system configurations:

SONALLEVE MR-HIFU V2 ACHIEVA 1.5T

SONALLEVE MR-HIFU V2 ACHIEVA 3T

SONALLEVE MR-HIFU V2 INGENIA 1.5T

SONALLEVE MR-HIFU V2 INGENIA 3T

This manual provides information on the correct and safe use of the Sonalleve MR-HIFU system.

These Instructions for Use are intended to assist users in the safe and effective operation of the

product described.

Before attempting to operate the system, you must read these Instructions for Use, noting and

strictly observing all WARNINGS and CAUTION notices.

Pay special attention to all the information given and procedures described in 2. Safety.

The intended use and standards compliance of the Sonalleve MR-HIFU product are described

in 1. Introduction to Sonalleve MR-HIFU. This chapter also explains the textual conventions

used in this manual.

The safety aspects of using the Sonalleve MR-HIFU system are described and important

instructions for the safe use of the product are given in 2. Safety.

An overview of the system components is given in 3. System overview.

The key terms and concepts related to working with Sonalleve MR-HIFU and an outline of the

different treatment methods are provided in 4. Treatment methods.

The basic organization and functions of the User Interface are explained in 5. User interface.

Instructions

for

Use

109745C2 / 02-2022

HIFU

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