Hitachi Mxs1 User manual

MN1-6260 Rev.2

Notes for operators and responsible maintenance personnel

★

Please read through this Instruction Manual as well as the separate Instruction

Manual “Safety (MN1-5980)” and “Cleaning, Disinfection and Sterilization

(MN1-5998)“ carefully prior to use.

★

Keep this Instruction Manual together with the ultrasound diagnostic instru-

ment for any future reference.

MXS1 Probe

Instruction Manual

Specication

MN1-6260 Rev.2

iii

MN1-6260 Rev.2

Introduction

This is the instruction manual for MXS1 probe. The probe is available by connecting to Hitachi's ultrasound diagnostic

instrument and can be mainly used for observation of cardiovascular.

Prior to use, read this manual as well as the separate instruction manual “Safety” in which information for safe use is

provided.

The probe bears the CE mark but the mark is valid only when the probe is connected to the ultrasound diagnostic

instrument bearing the CE mark.

Symbols used in this document

Safety information is classied into Danger, Warning, Caution, and Note according to the level of hazard. Those terms

are used in safety information provided to prevent hazards and injuries to the operator or patient.

Danger

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury to the

operator or patient.

Warning

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury to the

operator or patient.

Caution

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to

the operator or patient, or property damage only.

Note

Indicates a strong request concerning an item that must be observed in order to prevent damage or

deterioration of the equipment and also to ensure that it is used efciently.

The type of safety information is indicated by the symbols below.

This symbol means that attention is required.

This symbol means that the described action is prohibited.

This symbol means that the described action is mandatory.

MN1-6260 Rev.2

This instruction manual contains 4 pages of front matter and 8 pages of the main content.

CONTENTS

1. General Information...................................................................................................................................1

1-1. Intended use...................................................................................................................................................................1

1-2. Classication of ME equipment....................................................................................................................................1

1-3. Standard components ....................................................................................................................................................1

1-4. Options ..........................................................................................................................................................................1

2. Specications and Parts name....................................................................................................................3

2-1. Specications.................................................................................................................................................................3

2-2. Name of each parts........................................................................................................................................................4

3. Preparations before use .............................................................................................................................5

3-1. Visual check ..................................................................................................................................................................5

3-2. Conrmation of cleaning, disinfection, and sterilization.............................................................................................5

3-3. Operation check.............................................................................................................................................................5

4. Operation....................................................................................................................................................7

4-1. Temperature control system .........................................................................................................................................7

-1-

MN1-6260 Rev.2

1. General Information

General information for the probe is provided below.

1-1. Intended use

This probe is intended to be used by doctors or other qualified operators. The probe is placed on the body for

observation of surrounding organs.

Please refer to the ultrasound diagnostic instrument instruction manual used with this probe for the probe intended use

information.

Regarding with the connectable instrument, please refer to section 2-1. Specications of this manual.

Warning

Do not use this equipment for other than its intended use.

Otherwise it could cause burns or other injuries to the operator or the patient.

Do not performe a puncture.

This probe doesn’t support any puncture method .

1-2. Classication of ME equipment

This probe is classied as follows according to IEC60601-1.

Please refer to the section 2-1 for the applied part, the part treated as the applied part, and the range of IPX7.

• Classication based on the degree of protection against electric shock ........ Type BF applied part

• Classication for protection against ingress of liquids .................................. IPX7 (Watertight equipment)

• Operation mode............................................................................................... Continuous operation

• Method of sterilization.................................................................................... Refer to the separate instruction manual

“Cleaning, Disinfection and Sterilization”

1-3. Standard components