Hitachi C42t User manual

MN1-5823 Rev.6

Notes for operators and responsible maintenance personnel

★

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

Manual “Safety (MN1-5984)” and “Cleaning, Disinfection and Sterilization

(MN1-6000)“ carefully prior to use.

★

Keep this Instruction Manual together with the ultrasound diagnostic instru-

ment for any future reference.

C42T Probe

Instruction Manual

Specication

MN1-5823 Rev.6

iii

MN1-5823 Rev.6

Introduction

This is the instruction manual for C42T probe. The probe is available by connecting to Hitachi's ultrasound diagnostic

instrument and can be mainly used for observation of human internal organs during surgery.

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 the safety information provided to prevent hazards and injuries to the operator or patients.

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.

MN1-5823 Rev.6

This instruction manual contains 4 pages of front matter and 16 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 ..........................................................................................................................................................................2

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

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

2-1-3.Transducer cover when using the probe in neurosurgery application.............................................................4

2-2. Name of each parts........................................................................................................................................................5

3. Preparations before use .............................................................................................................................7

3-1. Visual check ..................................................................................................................................................................7

3-2. Conrmation of cleaning and sterilization...................................................................................................................7

3-3. Operation check.............................................................................................................................................................7

4. Operation....................................................................................................................................................9

4-1. Operation.......................................................................................................................................................................9

4-2. How to attach/release Magnetic Sensor Attachment and Magnetic Position Sensor ................................................10

4-2-1. How to attach Magnetic Position Sensor......................................................................................................10

4-2-2. How to release Magnetic Position Sensor ....................................................................................................11

4-3. How to mount/remove the transducer cover...............................................................................................................12

4-3-1. How to attach the transducer cover ..............................................................................................................12

4-3-2. How to remove the transducer cover............................................................................................................12

4-4. Precautions for neurosurgery application..................................................................................................................12

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MN1-5823 Rev.6

1. General Information

General information for the probe is provided below.

1-1. Intended use

This probe is intended to be used by doctors. The probe is placed in direct contact with human internal organs during

surgery for ultrasonic observation.

This probe can also be used for neurosurgery application if our specied transducer cover is mounted on the probe.

Please note that this probe is not allowed to be used for neurosurgery application in Japan. Regarding the precautions for

neurosurgery applications, please refer to the section 4-4.

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 patient or operator.

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 range of applied part, the part treated as 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