Hitachi Ust-5417 User manual

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MN1-5752 Rev.8

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.

Electronic Linear Probe

UST-5417

Instruction Manual

MN1-5752 Rev.8

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MN1-5752 Rev.8

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MN1-5752 Rev.8

This is an instruction for model UST-5417, an ultrasound probe.

Read the manual carefully before using the equipment. 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 ultrasound diagnostic

instrument 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 ultrasound diagnostic instrument 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 severities 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

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MN1-5752 Rev.8

CONTENTS

1. Safety Precautions .............................................................................................................................1

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 ...............................................................................................................................5

1-2-4. Option (Elasto coupler) Labels..................................................................................................... 9

2. Specications and Parts name.....................................................................................................11

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

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

2-2-1. Specications of the probe .............................................................................................12

2-2-2. Specications of the Elasto coupler* .............................................................................13

2-3. Performance ................................................................................................................................14

2-4. Names of each parts ....................................................................................................................14

2-5. Environmental conditions ...........................................................................................................15

2-5-1. Operating environmental conditions ..............................................................................15

2-5-2. Storage environmental conditions..................................................................................15

2-6. Classication of ME equipment..................................................................................................15

3. Preparations for Use .......................................................................................................................17

3-1. Start up check..............................................................................................................................17

3-1-1. Visual check....................................................................................................................17

3-1-2. Verication of cleaning, disinfection and sterilization...................................................17

3-1-3. Verication of operation.................................................................................................17

4. Usage....................................................................................................................................................19

4-1. Operation.....................................................................................................................................19

4-2. Attaching of the Elasto coupler ...................................................................................................20

4-3. Removal of the Elasto coupler ....................................................................................................21

4-4. Connecting to the ultrasound diagnostic instrument...................................................................22

4-5. Removing from the ultrasound diagnostic instrument................................................................23

4-6. Puncturing precautions................................................................................................................24

4-7. Actions to be taken when an abnormal state is detected .............................................................25

4-7-1. Ensuring safety of patients .............................................................................................25

4-7-2. Handling the utltrasound diagnostic instrument.............................................................25

5. Cleaning, disinfection and sterilization ..................................................................................27

5-1. Precautions for cleaning, disinfection and sterilization ..............................................................28

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MN1-5752 Rev.8

This Instruction Manual contains the main body of 52pages and 6pages until the CONTENTS.

5-2. Reprocessing instruction according to ISO 17664......................................................................29

5-3. Point of use (Pre-cleaning)..........................................................................................................31

5-4. Containment and transportation ..................................................................................................31

5-5. Manual cleaning and disinfection ..............................................................................................32

5-5-1. Manual cleaning ............................................................................................................33

5-5-2. Manual disinfection .......................................................................................................34

5-5-3. Cable and connector .......................................................................................................35

5-6. Automated cleaning and disinfecting .........................................................................................35

5-7. Applicable cleaners and disinfectants / Suppliers List ...............................................................36

5-8. Drying .........................................................................................................................................38

5-9. Maintenance, inspection and testing ...........................................................................................38

5-10. Packaging ..................................................................................................................................38

5-11. Sterilization ...............................................................................................................................39

5-11-1. Ethylene oxide (EtO) gas sterilization..........................................................................39

5-11-2. STERRAD®sterilization ..............................................................................................40

5-11-3. Liquid sterilization (USA only) ....................................................................................41

5-12. Storage.......................................................................................................................................41

6. Storage .................................................................................................................................................43

6-1. Actions before storing the probe .................................................................................................43

6-2. Environmental conditions for storage .........................................................................................43

7. Moving and Transporting .............................................................................................................45

7-1. Moving and transporting.............................................................................................................45

7-2. Preparing the probe for moving ..................................................................................................45

7-3. Packing for transportation...........................................................................................................45

7-4. Environmental conditions during transportation.........................................................................45

8. Periodic Inspection..........................................................................................................................47

8-1. Safety tests of the probe ..............................................................................................................47

8-2. Testing of measurement tolerances .............................................................................................48

8-2-1. Conducting tests .............................................................................................................48

8-2-2. Result judgment..............................................................................................................48

8-3. Safety tests of the Elasto coupler ................................................................................................48

9. Conguration.....................................................................................................................................49

9-1. Standard conguration ................................................................................................................49

9-2. Options ........................................................................................................................................49

10. Disposal of the Device ................................................................................................................51