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Hitachi EUP-CC531S - User Manual

Hitachi EUP-CC531S
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Biplane Transrectal / Vaginal Probe
EUP-CC531S
INSTRUCTION MANUAL
Tokyo , Japan
Q1E-EP1357-6
© Hitachi, Ltd. 2013,2017. All rights reserved.
Notes for operators and responsible maintenance personnel
Please read through this Instruction Manual carefully prior to use.
Keep this Instruction Manual together with the system with care to
make it available anytime.
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12
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Summary

About this manual

Warning Definitions

Explains WARNING, CAUTION, and NOTICE symbols and their meanings.

Graphical Symbols for Labeling

Manufacturer and Representative Info

Details of the manufacturer and authorized representative in the EU.

Symbol Meanings

Explains graphical symbols related to handling and warnings.

Definition of Symbols

Safety and Compliance Marks

Defines CE, IPX7, and Type BF APPLIED PART symbols.

Hazard and Warning Symbols

Explains general warning, voltage, biohazard, and disposal symbols.

1 Introduction

1.1 Features

Describes the probe's convex array scanning, acoustic output, and classification.

1.2 Principles of Operation

Explains how the probe and scanner generate ultrasound images.

1.3 Intended Use

1.4 Components

1.5 Accessories (Option)

1.5.1 Sterile Puncture Adapter EZU-PA5 V

Details the adapter for ultrasound guided biopsy and aspiration.

1.5.2 Puncture Guide Fixture EZU-PA3 U

Details the fixture for ultrasound guided transperineal biopsy.

1.5.3 Elastography Units

1.5.4 Balloon Kit and Probe Cover

1.5.6 Magnetic Sensor Attachment

1.5.7 Spacer for EZU-RV2 S

1.6 Construction

2 Inspection Before Use

2.1 Connection Inspection

Steps to confirm system operation and proper accessory connection.

2.2 Material Surface Inspection

Visual inspection of probe and accessories for damage like cracks or scratches.

3 Operation Procedure

3.1 Connection and Settings

Steps for connecting the probe, settings, and using probe covers.

3.2 General Instruction

3.3 Sterile Puncture Adapter (EZU-PA5 V)

3.4 Puncture Guide Fixture (EZU-PA3 U)

3.5 Needle Guide Line Display

4 Magnetic Sensor for EUP-CC531 S

4.1 Magnetic Sensor EZU-RV2 S

Introduces the EZU-RV2S magnetic sensor and shows its image.

4.1.1 Attaching the Magnetic Sensor

Step-by-step guide on attaching the magnetic sensor and its components.

4.1.2 Releasing the Magnetic Sensor

4.2 Magnetic Sensor EZU-RV3 S

4.2.1 Attaching the Magnetic Sensor

Step-by-step guide on attaching the EZU-RV3S magnetic sensor.

4.2.2 Releasing the Magnetic Sensor

5 Cleaning, Disinfection and Sterilization

Warnings

Lists important warnings for reprocessing probes with lumen.

Reprocessing Limitations

Details limitations on submerging the probe and cleaning methods.

Transportation Before Use

Instructions for packing and transporting the probe from CSSD.

Reprocessing Requirements Classification

Uncritical Classification

For application part contacting intact skin. Processing: Cleaning, Disinfection.

Semicritical Classification

For application part contacting mucosa. Processing: Cleaning, Disinfection.

Critical Classification

For application part contacting intracorporeal tissue. Processing: Cleaning, Disinfection, Sterilization.

5.1 Point of Use (Pre-cleaning)

5.2 Containment and Transportation

5.3 Manual Cleaning and Disinfection

5.4 Drying

5.5 Inspection

5.6 Packaging

5.7 Sterilization

5.8 Storage

6 Cleaning, Disinfection and Sterilization of EZU-PA3 U

Warnings

Lists warnings for reprocessing the EZU-PA3U, including dismantling.

Transportation Before Use

Instructions for packing and transporting the EZU-PA3U.

6.1 Point of Use (Pre-cleaning)

6.2 Containment and Transportation

6.3 Manual Cleaning and Disinfection

6.4 Automated Cleaning and Disinfection

6.5 Drying

6.6 Inspection

6.7 Packaging

6.8 Sterilization

6.9 Storage

7 Maintenance and Safety Inspection

7.1 Daily Inspection

Instructions for daily visual inspection of the probe and accessories.

7.2 Storage

Instructions for storing the probe and accessories after cleaning.

8 Safety Precautions

Cautions

Lists cautions related to probe usage, cleaning, and accessories.

9 Specifications

9.1 Probe Specifications

Provides detailed specifications for the EUP-CC531S probe.

9.2 Needle Guides (Option)

9.2.1 Sterile Puncture Adapter EZU-PA5 V Specifications

Lists specifications for the Sterile Puncture Adapter EZU-PA5V.

9.2.2 Puncture Guide Fixture EZU-PA3 U Specifications

9.3 Suppliers List

9.4 Suppliers List for EZU-PA3 U

10 Disposal of the Probe

Summary

About this manual

Warning Definitions

Explains WARNING, CAUTION, and NOTICE symbols and their meanings.

Graphical Symbols for Labeling

Manufacturer and Representative Info

Details of the manufacturer and authorized representative in the EU.

Symbol Meanings

Explains graphical symbols related to handling and warnings.

Definition of Symbols

Safety and Compliance Marks

Defines CE, IPX7, and Type BF APPLIED PART symbols.

Hazard and Warning Symbols

Explains general warning, voltage, biohazard, and disposal symbols.

1 Introduction

1.1 Features

Describes the probe's convex array scanning, acoustic output, and classification.

1.2 Principles of Operation

Explains how the probe and scanner generate ultrasound images.

1.3 Intended Use

1.4 Components

1.5 Accessories (Option)

1.5.1 Sterile Puncture Adapter EZU-PA5 V

Details the adapter for ultrasound guided biopsy and aspiration.

1.5.2 Puncture Guide Fixture EZU-PA3 U

Details the fixture for ultrasound guided transperineal biopsy.

1.5.3 Elastography Units

1.5.4 Balloon Kit and Probe Cover

1.5.6 Magnetic Sensor Attachment

1.5.7 Spacer for EZU-RV2 S

1.6 Construction

2 Inspection Before Use

2.1 Connection Inspection

Steps to confirm system operation and proper accessory connection.

2.2 Material Surface Inspection

Visual inspection of probe and accessories for damage like cracks or scratches.

3 Operation Procedure

3.1 Connection and Settings

Steps for connecting the probe, settings, and using probe covers.

3.2 General Instruction

3.3 Sterile Puncture Adapter (EZU-PA5 V)

3.4 Puncture Guide Fixture (EZU-PA3 U)

3.5 Needle Guide Line Display

4 Magnetic Sensor for EUP-CC531 S

4.1 Magnetic Sensor EZU-RV2 S

Introduces the EZU-RV2S magnetic sensor and shows its image.

4.1.1 Attaching the Magnetic Sensor

Step-by-step guide on attaching the magnetic sensor and its components.

4.1.2 Releasing the Magnetic Sensor

4.2 Magnetic Sensor EZU-RV3 S

4.2.1 Attaching the Magnetic Sensor

Step-by-step guide on attaching the EZU-RV3S magnetic sensor.

4.2.2 Releasing the Magnetic Sensor

5 Cleaning, Disinfection and Sterilization

Warnings

Lists important warnings for reprocessing probes with lumen.

Reprocessing Limitations

Details limitations on submerging the probe and cleaning methods.

Transportation Before Use

Instructions for packing and transporting the probe from CSSD.

Reprocessing Requirements Classification

Uncritical Classification

For application part contacting intact skin. Processing: Cleaning, Disinfection.

Semicritical Classification

For application part contacting mucosa. Processing: Cleaning, Disinfection.

Critical Classification

For application part contacting intracorporeal tissue. Processing: Cleaning, Disinfection, Sterilization.

5.1 Point of Use (Pre-cleaning)

5.2 Containment and Transportation

5.3 Manual Cleaning and Disinfection

5.4 Drying

5.5 Inspection

5.6 Packaging

5.7 Sterilization

5.8 Storage

6 Cleaning, Disinfection and Sterilization of EZU-PA3 U

Warnings

Lists warnings for reprocessing the EZU-PA3U, including dismantling.

Transportation Before Use

Instructions for packing and transporting the EZU-PA3U.

6.1 Point of Use (Pre-cleaning)

6.2 Containment and Transportation

6.3 Manual Cleaning and Disinfection

6.4 Automated Cleaning and Disinfection

6.5 Drying

6.6 Inspection

6.7 Packaging

6.8 Sterilization

6.9 Storage

7 Maintenance and Safety Inspection

7.1 Daily Inspection

Instructions for daily visual inspection of the probe and accessories.

7.2 Storage

Instructions for storing the probe and accessories after cleaning.

8 Safety Precautions

Cautions

Lists cautions related to probe usage, cleaning, and accessories.

9 Specifications

9.1 Probe Specifications

Provides detailed specifications for the EUP-CC531S probe.

9.2 Needle Guides (Option)

9.2.1 Sterile Puncture Adapter EZU-PA5 V Specifications

Lists specifications for the Sterile Puncture Adapter EZU-PA5V.

9.2.2 Puncture Guide Fixture EZU-PA3 U Specifications

9.3 Suppliers List

9.4 Suppliers List for EZU-PA3 U

10 Disposal of the Probe

Hitachi EUP-CC531S Specifications

General IconGeneral
BrandHitachi
ModelEUP-CC531S
CategoryMedical Equipment
LanguageEnglish

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