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Hitachi C41V Instruction Manual
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Hitachi C41V Instruction Manual

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C41V Probe 
INSTRUCTION MANUAL 
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.
Tokyo, Japan 
Q1E‐EP1363‐6 
© Hitachi, Ltd. 2013, 2017. All rights reserved. 
0123

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Summary of Contents for Hitachi C41V

  • Page 1 C41V Probe  INSTRUCTION MANUAL  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. Tokyo, Japan  Q1E‐EP1363‐6  © Hitachi, Ltd. 2013, 2017. All rights reserved.  0123...
  • Page 2 Manufacturer:  Hitachi, Ltd.  2‐16‐1, Higashi‐Ueno,Taito‐ku, Tokyo, 110‐0015, Japan  +81‐3‐6284‐3668    http://www.hitachi.com/businesses/healthcare/index.html      European  Hitachi Medical Systems GmbH  Representative:  Otto-von-Guericke-Ring 3 D-65205 Wiesbaden, Germany        EU Importer:  Hitachi Medical Systems Europe Holding AG  Address:  Sumpfstrasse 13 CH‐6300 Zug, Switzerland      Local Distributor:    Q1E-EP1363...
  • Page 3 About this manual This instruction manual contains safety precautions, the inspection, the operation procedure and the reprocessing procedure of C41V Probe. Please read this manual thoroughly to ensure the safety operation. If you have any questions concerning the operation of the probe, please contact a service support.
  • Page 4 Graphical Symbols for Use in Labeling of Hitachi Ultrasound Probes Some graphical symbols that are used in labeling of Hitachi Ultrasound Probes are compliant with EN980:2008 standard. Refer to the following table about the meanings of them. Explanation of Symbol...
  • Page 5 Definition of symbol The following symbol is also used for HITACHI Ultrasound Probes. Location Symbol Definition This instrument complies with Directive 93/42/EEC Probe relating Medical Device Directive connector 2011/65/EU relating to RoHS Probe IPX7 mark IPX7 connector See section 1.6.

  • Page 6: Table Of Contents

    CONTENTS Page 1. Introduction ················································· 1 Features ·················································· 1 Principles of operation ··································· 1 Intended Use ·············································· 2 Components ················································ 2 Accessories (Option) ······································ 3 Construction ·············································· 4 2. Inspection before Use ········································ 5 Inspection for Appropriate Connection ····················· 5 Inspection for Material Surface ···························...

  • Page 7: Introduction

    1. Introduction Features C41V Probe is a Convex Array Probe. The acoustic output of this probe when connected to ultrasound diagnostic scanner was measured according to the IEC60601-2-37 standard. The table of measured acoustic output data is contained in the operational manual of each ultrasound diagnostic scanner.

  • Page 8: Intended Use

    Intended Use C41V Probe is designed for observation and diagnosis of the following regions mainly by connecting with the HITACHI ultrasound diagnostic scanner.  General OB/GYN organs  Biopsy (with a Sterile Puncture Adapter)  Transvaginal/Transrectal WARNING Never use the probe for following regions.

  • Page 9: Accessories (Option)

    This mechanical compression unit is used for tissue elasticity imaging, by using the balloon attached to the probe that is connected to a Hitachi's digital ultrasound scanner system and electronic scanning ultrasound tomography system. Please refer to the instruction manual of option about the method of handling, cleaning and disinfection of EZU-TEMC1 and EZU-TEBL2.

  • Page 10: Construction

    Construction The external view of C41V Probe is shown in Fig. 1. Immersible part (IPX7) Applied part Cable Connector Un-immersible part Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water. Un-immersible part: This part should not be immersed in disinfectant solution and also cannot be cleaned by water.

  • Page 11: Inspection Before Use

    2. Inspection before Use Prior to use, the probe and accessories must be carefully inspected that they are appropriate for use. If you find any damage, do not use them and contact a service support immediately. Inspection for Appropriate Connection 1) Confirm that the system is correctly operating.

  • Page 12: Operation Procedure

    3. Operation Procedure Connection and Settings 1) Confirm that the probe is cleaned, disinfected and sterilized. 2) It is recommended to use a disposable probe cover for preventing a patient from infection and the probe cover should be made of allergy free material to avoid allergic reaction.
  • Page 13 6) Fix jelly on the top of the probe with sterile adhesive tape. (See Fig. 5.) Sterilized tape Fig. 5 7) Insert the probe gentry and adjust the probe’s position for a clear view of the desired image. By turning or tilting the probe, a “turn around”...

  • Page 14: Use Of Sterile Puncture Adapter (Ezu-Pa5V)

    Use of Sterile Puncture Adapter (EZU-PA5V) The process of attaching the Sterile Puncture Adapter (EZU-PA5V) to the probe is as follows. If the Sterile Puncture Adapter is used, careful handling is necessary to avoid damage of the probe cover. During open or minimal invasive surgery, use the protection sleeve to cover probe and cable.

  • Page 15: Display Of Needle Guide Line

    Display of Needle Guide Line When puncture is to be conducted, the needle guideline can be displayed by dot marks. Operation procedure for displaying the needle guideline on the ultrasound diagnostic scanner must be referred to the part of “Needle guide line” in the manual of the connected the ultrasound diagnostic scanner.

  • Page 16: Cleaning, Disinfection And Sterilization

    Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Disinfection Application part contacts (Disinfectant with intracorporeal tissue critical virucidal effect - directly minimum) (operative application) Sterilization According to the intended use, C41V probe is classified as semicritical. -10- Q1E-EP1363...

  • Page 17: Point Of Use (Pre-Cleaning)

    The flowchart of the reprocessing process of this probe is as follows. Manual cleaning and disinfection Drying Point of use Manual Cleaning (Pre-cleaning) Packing Rinsing after manual Containment and cleaning transportation Sterilization Manual Disinfection Rinsing after manual disinfection 4.1 Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after each (Pre-cleaning)

  • Page 18: Manual Cleaning And Disinfection

    4.3 Manual Cleaning and disinfection Manual cleaning Prepare following items before manual and disinfection cleaning and disinfection: Manual Cleaning a) Detergent: Cidezyme (Johnson & Johnson, #2258) or another cleaning agent with approved material compatibility for this Rinsing after manual medical device cleaning b) Disinfectant: Cidex OPA (Johnson &...

  • Page 19: Drying

    Manual disinfection: 1) Prepare the disinfectant solution in a tank with cold water (please follow the instructions of the disinfectant manufacturer regarding application, concentration, microbiological efficiency, service life and contact time). 2) Confirm the concentration of the disinfectant before immersing the ®...

  • Page 20: Packaging

    Packaging 4.6 Packaging Pack the probe in a sterile barrier such as Polypropylene fleece or ® transparent package made from Polyethylene film and Tyvek , and then place it into a tray. The tray should be also covered with a sterile barrier.

  • Page 21: Sterilization

    Sterilization 4.7 Sterilization The probe can be sterilized using either ethylen oxide gas (EtO) sterilization or plasma sterilization (see table below). Follow the manufacturer's instructions of the sterilizer regarding usage, temperature and sterilization-time. The sterilization method and operating conditions are as follows. ETO Gas Sterilizer, closed system ...

  • Page 22: Storage

    The packaging before sterilization is as follows. 1) Put the probe into TYVEK pouch. Probe TYVEK Pouch Fig. 9 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat sealer. Ensure that Sealed the seal is complete. Probe TYVEK Pouch Fig.

  • Page 23: Maintenance And Safety Inspection

    5. Maintenance and Safety Inspection Daily Inspection Visually inspect the surface of the probe head, housing, cable and connector for any crack, scratch or denaturalization. If you find any damage, do not use the probe and contact a service support immediately. Storage After using the probe, it should be cleaned and disinfected and sterilized...

  • Page 24: Safety Precautions

    1) Never use the probe if the probe head, shaft or cable are cracked or damaged. 2) When use C41V Probe for biopsy purpose, use Sterile Puncture Adapter EZU-PA5V (Option) certainly. 3) Never use the Sterile Puncture Adapter if the adapter is deformed, cracked or damaged.

  • Page 25: Specifications

    7. Specifications Probe Type: C41V Probe Acoustic working frequency: 6.5MHz Technology: Convex Array Probe Dimensions: See Fig. 12 Weight: Approx.0.60kg (Including cable and connector) Probe materials: Bio-compatible allergy free components Acoustic output: According to IEC 60601-2-37 (See Main Unit manual.)

  • Page 26: Sterile Puncture Adapter Ezu-Pa5V

    Sterile Puncture Adapter EZU-PA5V Type: EZU-PA5V External view: See Fig. 13 Acceptable needle gauge: 16G to 19G Materials: Bio-compatible allergy free components Classification: MDD classification IIa Package: 24 Sterile Puncture Adapters for single use Sterilization method: Sterilized with gamma irradiation Operating conditions: Temperature: -10 –...

  • Page 27: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with C41V Probe. Product name manufacturer purpose Cidezyme® Johnson & Johnson Enzymatic detergent STERANIOS 2% ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant CIDEX Johnson & Johnson Disinfectant CIDEX® plus™ 28 Johnson &...
  • Page 28 Unit: mm Fig. 12 External view of C41V Probe -22- Q1E-EP1363...
  • Page 29 Fig. 13 External view of C41V Probe with Sterile Puncture Adapter (EZU-PA5V) -23- Q1E-EP1363...

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