Hitachi UST-9133 Manuel utilisateur

Notes for operators and responsible maintenance personnel

★

Please read through this Instruction Manual carefully prior to use.

★

Keep this Instruction Manual together with the ultrasound diagnostic instru-

ment for any future reference.

Intraoperative Electronic Convex Probe

UST-9133

Instruction Manual

MN1-5241 Rev.21

iii

MN1-5241 Rev.21

This is an instruction for model UST-9133, an ultrasound probe.

Read the manual carefully before using the instrument. Take special note of the items in section 1, "Safety

Precautions".

Keep this manual securely for future reference.

The CE mark on the probe indicates that this probe is valid when it is connected to equipment

bearing the CE mark that is specied as available in section 2 of this document. Therefore, if a

probe bearing the CE mark is connected to equipment that is specied as available but does not

have a CE mark, part of this instruction manual may not apply.

Symbols used in this document

The terms below are used in the safety information provided to prevent hazards and injuries to the operator

or patients. The severity of the hazard and injury that can occur when failing to observe the displayed safety

information are indicated in four levels: "Danger", "Warning", "Caution"and "Note".

Danger

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

the operator or patient.

War ning

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 attention is required.

This symbol means that the described action is prohibited.

This symbol means the described action is mandatory.

Introduction

MN1-5241 Rev.21

CONTENTS

1. Safety Precautions

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

1-2. Usage precautions.............................................................................................................1

1-2-1. Warnings and safety information ....................................................................................2

1-2-2. Cleaning, disinfection and sterilization precautions............................................................4

1-2-3. Labels........................................................................................................................6

2. Specications and Parts name

2-1. Principles of operation....................................................................................................11

2-2. Specications..................................................................................................................12

2-3. Performance....................................................................................................................13

2-4. Names of each parts......................................................................................................13

2-5. Environmental conditions..............................................................................................14

2-5-1. Operating environmental conditions ............................................................................14

2-5-2. Storage environmental conditions ...............................................................................14

2-6. Classication of ME equipment .....................................................................................14

3. Preparations for Use

3-1. Start up check .................................................................................................................15

3-1-1. Visual check ............................................................................................................15

3-1-2. Verication of cleaning, disinfection and sterilization .....................................................15

3-1-3. Verication of operation ............................................................................................15

4. Usage

4-1. Operation ........................................................................................................................17

4-2. Connecting to the ultrasound diagnostic instrument ......................................................18

4-3. Removing from the ultrasound diagnostic instrument ...................................................19

4-4. Precautions when performing puncture operations ........................................................20

4-5. Actions to be taken when an abnormal state is detected.................................................21

4-5-1. Ensuring safety of patients..........................................................................................21

4-5-2. Handling the instrument ............................................................................................21

5. Cleaning, disinfection and sterilization

5-1. Precautions for cleaning, disinfection and sterilization..................................................24

5-2. Reprocessing instruction according to ISO 17664 ..........................................................25

5-3. Point of use (Pre-cleaning) ..............................................................................................27

5-4. Containment and transportation......................................................................................27

MN1-5241 Rev.21

5-5. Manual cleaning and disinfection ..................................................................................28

5-5-1. Manual cleaning .......................................................................................................28

5-5-2. Manual disinfection ...................................................................................................29

5-5-3. Cable and connecton ..................................................................................................29

5-6. Automated cleaning and disinfecting ............................................................................30

5-7. Applicable cleaners and disinfectants / Suppliers List ....................................................31

5-8. Drying.............................................................................................................................33

5-9. Maintenance, inspection and testing...............................................................................33

5-10. Packaging ......................................................................................................................33

5-11. Sterilization ...................................................................................................................34

5-11-1. Ethylene oxide (EtO) gas sterilization..........................................................................34

5-11-2. STERRAD®sterilization ...........................................................................................35

5-11-3. Liquid sterilization (USA only)...................................................................................36

5-12. Storage ..........................................................................................................................36

6. Storage

6-1. Actions before storing the probe.................................................................................37

6-2. Environmental conditions for storage............................................................................37

7. Moving and Transporting

7-1. Moving and transporting ..............................................................................................39

7-2. Preparing the probe and accessories for moving ............................................................39

7-3. Packing for transportation ............................................................................................39

7-4. Environmental conditions during transportation .........................................................39

8. Periodic Inspection

8-1. Safety tests.....................................................................................................................41

8-2. Testing of measurement tolerances.................................................................................42

8-2-1. Conducting tests ...........................................................................................................42

8-2-2. Result judgement .........................................................................................................42

9. Conguration

9-1. Standard conguration...................................................................................................43

9-2. Options............................................................................................................................43

10. Disposal of the Device .......................................................................................................45

This Instruction Manual contains the main body of 46pages and 5pages until the CONTENTS.

MN1-5241 Rev.21

-1-

MN1-5241 Rev. 21

1. Safety Precautions

1-1. Intended use

This probe is intended for use by a doctor when placed into direct contact with human internal organs during

surgery making ultrasonic observations.

Caution

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

Use for other purposes can cause burns or other injuries to the patient or operator.

1-2. Usage precautions

The terms below are used in the safety information provided to prevent hazards and injuries to the operator

or patients. The severity of the hazard and injury that can occur when failing to observe the displayed safety

information are indicated in four levels: "Danger", "Warning", "Caution" and "Note".

Danger

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

the operator or patient.

War ning

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 attention is required.

This symbol means that the described action is prohibited.

This symbol means the described action is mandatory.

-2-

MN1-5241 Rev. 21

1-2-1. Warnings and safety information

War ning

Follow the information in this manual and the documentation supplied with any equipment used

together with this probe.

Use that is not in accordance with the supplied documentation can result in a serious or moderate

injury, equipment breakdown or physical damage that impairs operation.

Be sure to preparations for use.

Use of the probe while failing to notice an abnormal condition can result in injury to the operator or

patient. If any abnormalities are noted on the probe in the start up inspection, immediately stop using

it and contact one of our ofces and/or distributor's ofces listed on the back cover. See section 3-1

"Start up check" for the start up inspection content and procedure.

This equipment must not be used in direct contact with the heart.

This may cause patient to receive an electric shock.

Do not use on the eyes.

This probe is not intended for use on the eyes. The acoustic output can have an adverse effect on the eyes.

This probe must not be used in direct with the central nervous system. (Except USA)

Do not attempt to disassemble, modify or repair the probe.

Electric shock or other unforeseen accidents could result. Contact one of our ofces and/or distribu-

tor's ofces listed on the back cover to request repair.

Clean, disinfect and sterilize before using the probe.

Perform proper cleaning, disinfection and sterilization after use.

Otherwise, there is a risk of infection. Note that the probe is not sterilized at the factory.

Before using the probe rst, be sure to clean, disinfect and sterilize it.

Be sure to sterilize the probe which blood adhered.

Otherwise, there is a risk of infection.

During surgery, be sure to wear sterilized medical gloves.

Conducting examinations with the bare hands can expose the operator to a risk of infection.

For the acoustic medium, use sterilized physiological saline.

Using an unsterilized ultrasound medium can cause an infection on the patient.

Dispose the probe used for patients with Creutzfeldt-Jakob disease.

Otherwise, there is a risk of infection to the operator or patient. Our ultrasound probe is not compatible

with any disinfection/sterilization method for Creutzfeldt-Jakob disease.

When using ultrasound contrast agent, follow the supplied documentation.

Unexpected accidents could result. Check the state of the patient and take appropriate precautions

to avoid side effects.

Do not use the probe fallen on to oor.

Ohterwise, there is a risk of infection. Stop the operation and perform the procedure in section 8

"Periodic Inspection", section 5 "Cleaning, disinfection and sterilization" and section 3-1 "Start up

check".

-3-

MN1-5241 Rev. 21

Caution

Constantly check for anything abnormal about the patient’s condition and probe.

Continued use without noticing that an abnormal condition has occurred can result in an electric

shock and injury to the operator or patient. If an abnormal condition occurs, immediately move the

probe away from the patient and stop use of the probe.

The probe is vulnerable to damage by impact. Therefore, handle it with care.

There is a risk of damage to the probe when the probe is fallen or hit somewhere.

Do not use this probe with other equipment except for those specically approved in the manual.

Use with unapproved equipment can result in an electric shock, burn or other injury to the patient or

operator and damage to the probe and the other equipment.

Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output.

Overuse can adversely affect the internal tissues of the patient.

For details about the acoustic output, please refer to the documentation supplied with the ultrasound

diagnostic instrument.

Do not use it in continuous contact with the human body more than 60 minutes.

Overuse can adversely affect the internal tissues of the patient.

Regularly perform maintenance inspection and safety tests of the ultrasound diagnostic instrument

and probe.

If you use equipment for a long period of time, it can reduce the performance or cause smoke or

re. If anything unusual occurs, immediately stop using it and contact one of our ofces and/or

distributor's ofces listed on the back cover.

Use, move and transport the probe under the environmental conditions specied in this manual.

Otherwise, it may be damaged.

See section 2-5 "Environmental conditions" and section 7-4 "Environmental conditions during

transportation".

-4-

MN1-5241 Rev. 21

1-2-2. Cleaning, disinfection and sterilization precautions

War ning

Wear protective gloves and other protective gear during cleaning, disinfection and sterilization.

Handling of the probe with your bare hands before disinfection or sterilization can result in an

infection.

After soaking in cleaning agents, thoroughly wash the probe with running water.

Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient.

After soaking in a disinfectant, throughly wash the equipment with deionized water. Leavings of the

disinfectant can cause an adverse reaction on the bodies of the operator or patient.

Perform aeration completely after gas disinfection and sterilization.

Residual gas can cause an adverse reaction on the bodies of the operator or patient.

Do not clean, disinfect or sterilize using procedures other than those specied in this manual.

Infection could result due to incomplete cleaning, disinfection and sterilization. It can also result in

damage to the probe or reduced performance. The probe cannot withstand autoclave sterilization or

boiling and other types of sterilization at temperatures exceeding 60°C (140°F).

For details on the usage conditions of chemicals and sterilization procedures, refer to the documentation

supplied with the respective chemical or sterilization equipment.

Infection could result due to incomplete disinfection or sterilization. This could also cause

deterioration of the probe.

Caution

Do not place the probe tip in any liquids beyond the range

shown in the gure right.

Use when liquid has gotten inside the connector can result in

a risk of electric shock to the operator or patient. If liquid gets

inside the connector, immediately stop use and contact one of

our ofces and/or distributor's ofces listed on the back cover.

Water or chemical solution

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