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Hitachi C41L47RP Instruction Manual
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Hitachi C41L47RP Instruction Manual

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C41L47RP 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-EP1451-6
© Hitachi, Ltd. 2013,2017. All rights reserved .
0123

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  • Page 1 ★ 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-EP1451-6 © Hitachi, Ltd. 2013,2017. All rights reserved . 0123...
  • Page 2 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 Representative: Hitachi Medical Systems GmbH 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: ( 1 ) Q1E-EP1451...
  • Page 3 About this manual This instruction manual contains safety precautions, the inspection, the operation procedure and the reprocessing procedure of C41L47RP 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 relating to Probe connector Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.6.

  • Page 6: Table Of Contents

    3.1 Connection and Settings .......... 6 3.2 Use of Puncture Guide Fixture (EZU-PA3U) ......10 3.3 How to adjust Puncture Guide Fixture (EZU-PA3U) ....11 4. Option of C41L47RP Probe ........13 4.1 Magnetic sensor ..........13 5. Cleaning, Disinfection and Sterilization ....15 5.1 Point of use (Pre-cleaning) ........
  • Page 7 7.1 Daily Inspection ..........33 7.2 Store ............33 8. Safety Precautions .......... 34 9. Specifications ..........36 9.1 Probe ............36 9.2 Puncture Guide Fixture EZU-PA3U ......... 37 9.3 Suppliers List ..........37 9.4 Suppliers List for EZU-PA3U ........38 10.

  • Page 8: Introduction

    1. Introduction Features C41L47RP Probe is a transrectal 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 9: Intended Use

    Intended Use C41L47RP Probe is designed for observation and diagnosis of the following regions mainly by connecting with the HITACHI ultrasound diagnostic scanner. Transrectal  Biopsy (with a Puncture Guide Fixture)  WARNING Never use the probe for following regions.

  • Page 10: Accessories (Option)

    Accessories (Option) 1.5.1 Puncture Guide Fixture EZU-PA3U (Gauge size available:14G and 18G) If you need a Puncture Guide Fixture EZU-PA3U, please contact a service support. CAUTION A well-trained physician only should perform a biopsy. 1.5.2 Probe cover for Single Use (Disposable) To protect the probe against contamination, using probe cover is recommended.

  • Page 11: Construction

    Construction The external view of C41L47RP Probe is shown in Fig.1. Immersible part (IPX7) Applied part Head Band groove Immersible This part can be immersed in part: disinfectant solution and also can be cleaned by water. Un-immersible This part should not be immersed...

  • Page 12: Inspection Before Use

    2. Inspection before Use Prior to use, the probe and the Puncture Guide Fixture 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 2.1.1 Confirm that the system is correctly operating.

  • Page 13: Operation Procedure

    Real-time Virtual Sonography(RVS). Regarding the option for RVS, please refer to “4.Option of C41L47RP Probe”. 2) It is recommended to use a disposable probe cover for preventing a patient from infection and the probe cover should be allergy free material to avoid allergic reaction.
  • Page 14 Right-left orientation mark Fig.3 The relationship between the direction of the probe and the Right-left Orientation Mark in Linear US image WARNING Be careful with a probe cover made from the latex. The latex may cause such allergic reactions as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, and depression of blood pressure, shock and so on.
  • Page 15 CAUTION ・ Do not use the probe if the image and the frequency do not match the probe. An incorrect acoustic output can result in burns or other injuries to the patient. ・ Scan for the minimum length of time necessary for the diagnosis and at the lowest possible output.
  • Page 16 CAUTION The needle echo image corresponds with the needle guideline, but the actual distance from the surface of acoustic lens to the needle guideline is approximate 3mm shorter than the numeric value in the upper right on US image, so the numeric value is rough indication for biopsy.

  • Page 17: Use Of Puncture Guide Fixture (Ezu-Pa3U)

    Use of Puncture Guide Fixture (EZU-PA3U) The steps to attach the Puncture Guide Fixture(EZU-PA3U) to the probe is as follows. 1) Attaching a sterile probe cover to the probe is recommended. 2) Fit the groove of the Puncture Guide Fixture to the projection on the probe.

  • Page 18: How To Adjust Puncture Guide Fixture (Ezu-Pa3U)

    How to adjust Puncture Guide Fixture (EZU-PA3U) 1) Loose thumbscrew on the back side of the puncture guide. 2) Slide guide groove in the depth on demand. 3) Tighten thumbscrew for fixing guide groove. The Following figure is an example that guide groove of 14G is combined with the depth of 30mm Guide Thumbscrew...
  • Page 19 WARNING 1) Warning in case of using probe covers which latex is contained to. The latex may cause such allergic reactions as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, depression of blood pressure, shock and so on. For the patients suspected of latex allergy, do not use the latex-containing medical devices.

  • Page 20: Option Of C41L47Rp Probe

    4. Option of C41L47RP Probe Magnetic sensor 4.1.1 How to attach the Magnetic sensor The procedure of attaching the magnetic sensor is as follow. Confirm that the Magnetic sensor attachment is sterilized or disinfected. Insert the Magnetic sensor into the Magnetic sensor attachment in the correct direction as shown in Fig.6.
  • Page 21 4.1.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor is as follow. 1) Detach the Magnetic sensor attachment from the probe as shown in Fig.8. Fig.8 How to release the Magnetic sensor attachment from the probe 2) Detach the Magnetic sensor from the Magnetic sensor attachment as shown in Fig.9.

  • Page 22: Cleaning, Disinfection And Sterilization

    5. Cleaning, Disinfection and Sterilization The probe and accessory must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. ‐ The probe is delivered unsterile. Prior to the first use, reprocess the probe. ‐ Temperature should not exceed 60°C during WARNINGS reprocessing ‐...
  • Page 23 (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, C41L47RP probe is classified as semicritical. - 16 - Q1E-EP1451...
  • Page 24 The flowchart of the reprocessing process of this probe is as follows. Point of use (Pre-cleaning) Containment and transportation Manual cleaning and disinfection Manual Cleaning Rinsing after manual cleaning Manual Disinfection Rinsing after manual disinfection Drying Packing Sterilization - 17 - Q1E-EP1451...

  • Page 25: Point Of Use (Pre-Cleaning)

    (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A) C41L47RP probe 1) Remove the protective cover. 2) Clean the probe of all patient’s blood or fluid with running tap water until the surface of the probe looks visually clean.

  • Page 26: Manual Cleaning And Disinfection

    Prepare the detergent solution in a tank with cold water (please follow the instructions of the detergent manufacturer regarding application, dilution and contact time). A) C41L47RP probe The temperature of the detergent solution should be between 15-30 °C, concentration is 1.6%. Please note the minimum contact time of the detergent in the manufacturer’s instruction.
  • Page 27 The immersible part of the probe should be left in the detergent solution according to the specified contact time of the detergent manufacturer. Wipe the un-immersible parts of the probe with a soft cloth dipped with the detergent solution. Rinse the immersible part of the probe with running tap water for 1 minute.
  • Page 28 Manual disinfection: A) C41L47RP probe 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 probe.

  • Page 29: Drying

    B) Magnetic sensor attachment 1) Prepare the disinfectant solution as stated in the procedure for the probe. 2) Immerse the Magnetic sensor attachment into the disinfectant (see Fig. 10). Set a clock to insure the recommended contact time which is 5 minutes. 3) Rinse the Magnetic sensor attachment with deionized water for 1 minute.

  • Page 30: Inspection

    Inspection Inspect the equipment for any damage such as crack, scratch or deformation. Do not use it if any damage is found. Packaging Packaging Pack the equipment in a sterile barrier such as Polypropylene fleece or transparent package made from Polyethylene film and Tyvek®, and then place it into a tray.

  • Page 31: Sterilization

    Sterilization Sterilization The probe and accessory 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. Sterilization Method Condition Plasma Sterilization:...
  • Page 32 The packaging before sterilization is as follows. 1) Put the probe into TYVEK pouch. Probe TYVEK Pouch Fig.11 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat sealer. Ensure that the seal is complete. Sealed TYVEK Pouch Probe Fig.12 Sealing - 25 -...

  • Page 33: Storage

    3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for Probe in sterilization the Pouch Fig.13 Packaging in a tray Storage Store the equipment in a cool, dustproof and dark space to avoid high temperature, humidity and direct sunlight. Limitations for the time for sterilized equipment belong to package.

  • Page 34: Cleaning, Disinfection And Sterilization Of Ezu-Pa3U

    6. Cleaning, Disinfection and Sterilization of EZU-PA3U EZU-PA3U must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. EZU-PA3U is delivered unsterile. Prior to the first WARNINGS use, reprocess it. EZU-PA3U should be packed in a sterile pouch or container to transport from Central Sterile Supply Transportation Department (CSSD) to an operating room.

  • Page 35: Point Of Use (Pre-Cleaning)

    Point of use (Pre-cleaning) Point of use (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: 1) Remove the EZU-PA3U from the probe. 2) Disassemble the EZU-PA3U (Fig.14) and immerse all parts in sufficient amount of high quality tap water. Scrub them using soft cloth to remove all visible soil and dried protein from their surface.
  • Page 36 d) Two tanks, one for cleaning and one for disinfection - optional: 1 additional tank for rinsing with deionized/tap water (sufficient size for immersion of the puncture guide fixture at full length) e) Soft, fluff free cloth or single use towel f) Personal protective equipment (gloves, water repellent protective skirt, face protection mask or protective glasses, see also instructions of the manufacturer for the detergent and the...

  • Page 37: Automated Cleaning And Disinfection

    Manual disinfection: 1) Prepare the disinfectant solution as stated in the procedure for the probe. 2) Immerse the parts of the EZU-PA3U into the disinfectant. Set a clock to insure the recommended contact time which is 5 minutes. 3) Rinse the parts of the EZU-PA3U with deionized water for 1 minute. (alternatively: immerse them in a tray filled with deionized water for 5 min.) 4) Visually check the outer surface of the parts of the EZU-PA3U for...

  • Page 38: Drying

    1) The parameters of the cleaning and disinfection of the device are as follows: Program step Water (40 l) Dosage (ml/l) Temp. (°C) Time (min) Pre-Rinse Cold water Cleaning Deionized water 5 (0.5%) Rinse Deionized water Disinfection Deionized water 10 (1%) Rinse Deionized water Rinse...

  • Page 39: Sterilization

    Sterilization Sterilization EZU-PA3U can be sterilized using ethylen oxide gas (EtO) sterilization plasma sterilization, or Steam sterilization. Follow the manufacturer's instructions of the sterilizer regarding usage, temperature and sterilization-time. The sterilization method and operating conditions are as follows. Sterilization Method Condition Plasma Sterilization: STERRAD®...

  • Page 40: Maintenance And Safety Inspection

    7.1.2 Visually inspect the Puncture Guide Fixture for deformation or denaturalization. If you find any damage, do not use the Puncture Guide Fixture and contact your local HITACHI distributor immediately. 7.1.3 Visually inspect the surface of the Magnetic sensor attachment for any crack, deformation or denaturalization.

  • Page 41: Safety Precautions

    The ultrasound gel attached to the ultrasound scanner as one of accessories is not sterile so never use it with C41L47RP. Do not attempt to disassemble, modify, or repair the probe. Electric shock or other unforeseen accidents could result.
  • Page 42 CAUTION Keep the acoustic power low and minimize the ultrasound exposure time for the examination of an early pregnancy. Do not expose the connector to water or other liquids. The connector is not waterproof. Do not hit or drop the probe. The probe is easily damaged by mechanical shock.

  • Page 43: Specifications

    9. Specifications Probe Type : C41L47RP Probe Acoustic working frequency Convex scanning : 6.5MHz Linear scanning : 7.5MHz Technology : High density Convex Array and Linear Array Probe Dimensions : See Fig.15 Weight : Approx.1.3kg (Including cable and connector) Scanning angle (Convex) : 200 deg...

  • Page 44: Puncture Guide Fixture Ezu-Pa3U

    Cleaning : Applicable detergents are listed in the suppliers list Sterilization : Steam Sterilization Suppliers List The products listed below are seriously tested and approved for use with C41L47RP Probe. Product name manufacturer purpose Cidezyme® Johnson & Johnson Enzymatic detergent...

  • Page 45: Suppliers List For Ezu-Pa3U

    Suppliers List for EZU-PA3U The products listed below are seriously tested and approved for use with EZU-PA3U. Product name manufacturer purpose Cidezyme® Johnson & Johnson Enzymatic detergent CIDEX® OPA Johnson & Johnson Disinfectant Korsolex® Endo-Cleaner Bode Chemie Detergent Korsolex® Endo-Disinfectant Bode Chemie Disinfectant Please contact your local distributor for a current version of the "Disinfectant/Sterilization Method Compatibility for Ultrasound Probe...
  • Page 46 2200 2200 Φ22.8 Unit: mm Fig.15 External view of C41L47RP Probe - 39 - Q1E-EP1451...
  • Page 47 Unit: mm Fig.16 Dimension Diagram with the Puncture Guide Fixture (EZU-PA3U) - 40 - Q1E-EP1451...
  • Page 48 Unit: mm Fig.17 Dimension Diagram with the Magnetic sensor attachment - 41 - Q1E-EP1451...

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