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Hitachi C22P Instruction Manual
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Hitachi C22P Instruction Manual

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C22P 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‐EP1457‐7 
 
© Hitachi, Ltd. 2013,2017. All rights reserved.
 
0123

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  • Page 1 C22P 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‐EP1457‐7    © 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 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: Q1E-EP1457...
  • Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, and disinfecting and/or sterilizing the HITACHI ultrasound probes. It also describes safety considerations, maintenance. For instructions for operating the ultrasound diagnostic scanner, refer to the operation manual for it.
  • 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

    CONTENTS Page 1. General ······················································· 1 Features ··················································· 1 Principles of operation ···································· 1 Intended Use ··············································· 2 Components ················································· 2 Option ····················································· 3 External View ·············································· 4 2. Inspection before Use ········································· 5 Inspection for Appropriate Connection ······················ 5 Inspection for Material Surface ····························...

  • Page 7: General

    1. General 1.1 Features C22P Probe is a Convex Array type. 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 operation manual of each ultrasound diagnostic scanner.

  • Page 8: Intended Use

    1.3 Intended Use C22P Probe is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound diagnostic scanner.  Biopsy (with Biopsy Attachment)  General abdominal organs WARNING Never use the probe for following applications.
  • Page 9 1.5 Option 1.5.1 Needle Guide Bracket EZU-PA7C2 1) Needle guide bracket ······· 1 piece 2) Brush ······················ 1 piece 3) Spring (Spare) ············· 2 pieces 4) Instruction manual ········· 1 copy 5) Case ······················· 1 piece 1.5.2 Attachment It becomes easy to have the probe by attaching the attachment to the probe and improves operability.

  • Page 10: External View

    1.6 External View The external view of C22P is shown in Fig. 1. Immersible part (IPX7) Cable Connector Scan head Applied part Attachment Un-immersible part Fig. 1 External View Needle Guide Bracket EZU-PA7C2 Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water.

  • Page 11: Inspection Before Use

    2. Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. If you find any damage, do not use the probe and immediately contact a service support. 2.1 Inspection for Appropriate Connection 2.1.1 Confirm that the system is correctly operating.
  • Page 12 3) Put the probe in sterile water and confirm that the needle echo at each angle overlaps with the correspondent biopsy guideline (See Fig. 2). Test needle Sterile water (Water temperature, see 2.2.2 2)) Right-left orientation mark Needle echo (a solid line) Biopsy guide line (a dotted line) 9°...
  • Page 13 4) Confirm that the needle guide angle corresponds to the angle indicated on the monitor. The needle guide angle is engraved on bracket. (See Fig. 3) Needle guide angle is engraved Needle guide angle 21° Fig. 3 Needle guide angle 5) Visually inspect the cover to ensure that there are no defects or holes.

  • Page 14: Operation Procedure

    3. Operation Procedure 3.1 Probe 1) Confirm that the probe and the attachment are cleaned, disinfected and if necessary sterilized. 2) Attach the attachment to the probe according to 3.2. 3) Connect the probe to the ultrasound diagnostic scanner, operate the scanner, and adjust the image, all according to the instructions given in the operation manual for the ultrasound diagnostic scanner with which the probe is used as connected.

  • Page 15: Attachment

    5) Use a sterile probe cover to protect the probe. The probe cover should be allergy free material to avoid allergic reaction. Between the probe and the probe cover, acoustic coupling gel is required as a couplant. 6) Place the probe on the examination site and adjust the probe’s position for a clear view of the desire image.
  • Page 16 The magnetic sensor enables Real-Time Virtual Sonography (RVS) when it is attached to the probe. 3.2.1 Attaching the Magnetic Sensor The procedure of attaching the Magnetic sensor is as follows. 1) Attach the Magnetic sensor into the attachment with the correct direction as shown in Fig.
  • Page 17 3.2.2 Removing the Magnetic Sensor The procedure of releasing the Magnetic sensor from the probe is as follows. 1) Press the area of the attachment shown with the arrow toward the direction A, and then slide out the attachment toward the direction B as shown in Fig.

  • Page 18: Needle Guide Bracket Ezu-Pa7C2

    3.3 Needle Guide Bracket EZU-PA7C2 1) Confirm that the needle guide bracket is cleaned and disinfected, and the probe is cleaned and disinfected/ sterilized. 2) Fit the needle guide bracket to the probe following “3.3.1 Fitting the needle guide bracket to the probe”. Never apply excessive force to attach the needle guide bracket to the wrong position.
  • Page 19 In the case of the CIVCO Ultra Pro 3™, push the green quick release lever of the needle guide toward the bracket to open the needle insert, and then remove the needle. For details of the removing procedure of the needle, refer to the Reference Guide each of the Ultra Pro II™...
  • Page 20 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 21 3.3.1 Fitting the needle guide bracket to the probe 1) Insert the recess of needle guide bracket to the needle guide bracket mount part. (See Fig. 11) Needle guide bracket Needle guide bracket mount part Needle guide attachment area Fig. 11 Position for mounting the needle guide bracket 2) Fit the recess of the bracket to the thumbscrew 1 and tighten the thumbscrew 1.
  • Page 22 3.3.2 Placing the probe and bracket into a transducer cover 1) Place an appropriate amount of gel inside the cover and/or on the Probe head. (See Fig. 13) CIV-FLEX cover Probe head Sterilized gel Fig. 13 Placing the gel 2) Insert the probe into the cover. 3) Pull the cover tightly over the probe face to remove wrinkles and air bubbles, taking care to avoid puncturing the cover.
  • Page 23 3.3.3 Attaching the needle guide to the bracket (Example: In the case of CIVCO Ultra-Pro II™) 1) Attach the unlocked needle guide onto the needle guide attachment area of the bracket. (See Fig. 14) Needle guide attachment area Needle guide Lock Fig.
  • Page 24 3) Select a needle insert to correspond with the needle size intended to be used in the procedure. 4) Slide the needle insert into the needle guide by aligning the arrow tips. (See Fig. 16) Inspect the guide and cover assembly to ensure the needle path is clear of obstructions.
  • Page 25 3.3.4 Setting the needle guide angle Pull the knob(①) and release it into the recess of appropriate angle of the bracket(②). Needle guide angles are engraved on the bracket. (See Fig. 17) Recess of ① the bracket Knob ② Needle guide angle are engraved Fig.

  • Page 26: Reprocessing Procedure

    4. Reprocessing Procedure 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. ‐ WARNINGS Temperature should not exceed 60°C during reprocessing.
  • Page 27 Levels of reprocessing requirements: Depending on the application of the product and with regard to risk evaluation, the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as uncritical, semi-critical or critical. Supporting information concerning this topic is listed in the table below.

  • Page 28: Point Of Use (Pre-Cleaning)

    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 -22- Q1E-EP1457...

  • Page 29: Point Of Use (Pre-Cleaning)

    (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A) C22P 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 30 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) C22P probe 1) 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 31 A) C22P 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 32 4.4 Drying Drying 1) Wipe the equipment with a single-use, fluff-free wipe or towel to remove moisture from the surface of the equipment. 2) Dry the equipment naturally in an ambient temperature between 15-30°C for a minimum of 4 hours. Alternatively the equipment can be dried using a drying heater at a temperature of less than 55 °C.
  • Page 33 The sterilization method and operating conditions are as follows. Sterilization Method Condition Plasma Sterilization: Short Cycle STERRAD® 50, 100S or 200 (*) Plasma Sterilization: Standard cycle Sterrad® NX or 100NX (*) Gas Type: 10% EO/ 90% HCFC  Temperature: 50-55°C ...
  • Page 34 2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Pouch Sealed complete. Attachment Probe Fig. 20 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for Tray for sterilization. sterilization Probe in the Pouch Fig.
  • Page 35 5. Cleaning and Disinfection of EZU-PA7C2 EZU-PA7C2 must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. ‐ EZU-PA7C2 is delivered unsterile. Prior to the first use, reprocess it. ‐ The cavities and the spiral spring of the EZU-PA7C2 require particular attentions...

  • Page 36: Manual Cleaning And Disinfection

    The flowchart of the reprocessing process of EZU-PA7C2 is as follows. Point of use (Pre-cleaning) Containment and transportation Manual cleaning and disinfection Manual Cleaning Washer Disinfector (WD) Rinsing after manual Automated Cleaning cleaning Automated Disinfection Manual Disinfection Rinsing after manual disinfection Drying Packing...

  • Page 37: Automated Cleaning And Disinfection

    5.1 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 contaminated needle guide and probe cover from the probe with needle guide bracket and dispose them appropriately. 2) Remove the needle guide bracket from the probe.
  • Page 38 Prepare following items before manual cleaning and disinfection: a) Detergent: Cidezyme® (Johnson & Johnson, #2258) or another cleaning agent with approved material compatibility for this medical device. b) Disinfectant: Cidex® OPA (Johnson & Johnson, # 20391) or another disinfectant with approved material compatibility for this medical device c) Cleaning brushes if applicable d) Two tanks, one for cleaning and one for disinfection - optional:...
  • Page 39 6) All parts of the needle guide bracket should be left in the detergent solution according to the specified contact time of the detergent manufacturer. 7) Rinse all parts of the needle guide bracket with running tap water for 1 minute. (alternatively: immerse them in a tray filled with deionized water/tap water (see Fig.

  • Page 40: Drying

    5.4 Automated cleaning and disinfection The following items must be provided prior to automated cleaning and disinfection: a) Washer disinfector: according 15883 with chemo-thermal program (temperature: max. 60°C) b) Detergent: Korsolex® Endo-Cleaner (Bode Chemie; #972020) or another cleaning agent with approved material compatibility for this medical device c) Disinfectant: Korsolex®...

  • Page 41: Packaging

    Drying 5.5 Drying 1) Wipe all parts of the needle guide bracket with a single-use, fluff-free wipe or towel to remove moisture from the surface of them. 2) Dry all parts of the needle guide bracket naturally in an ambient temperature between 15-30°C for a minimum of 4 hours.

  • Page 42: Safety Precautions

    Never use the probe if the probe head, housing or cable are cracked or damaged.  When use this Probe (C22P) for biopsy purpose, use Needle Guide Bracket EZU-PA7C2 (Option) certainly.  Do not attempt to disassemble, modify, or repair the probe. Electric shock or other unforeseen accidents could result.
  • Page 43 CAUTION  By examination of an early pregnancy the exposure time shall be as short as possible. Start examination with acoustic output power set to L (Low).  The probe connector is not waterproof. Do not allow liquid to contact the connector.

  • Page 44: Specifications

    8. Specifications 8.1 Probe Type: C22P Probe Acoustic working 3.0MHz Frequency: Technology: Convex Array Probe Dimensions: See Fig. 23 and Fig. 24. Weight: Approx. 0.70kg (Including cable and connector) Probe materials: Biocompatible allergy free components Acoustic output: According to IEC60601-2-37 (See Main Unit manual) Applicable systems: Depending on production and upgrade status for detailed information, contact a service support.

  • Page 45: Suppliers List Of The Probe

    8.2 Suppliers List of the Probe The products listed below are seriously tested and approved for use with C22P. Product name manufacturer purpose Cidezyme® Johnson & Johnson Enzymatic detergent STERANIOS 2% ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant CIDEX Johnson & Johnson Disinfectant CIDEX®...

  • Page 46: Needle Guide Bracket Ezu-Pa7C2

    8.3 Needle Guide Bracket EZU-PA7C2 Dimensions: See Fig. 25 and Fig. 26 Applicable probe: C22P Probe Needle angle: 9 and 21 degree 8.4 Suppliers list of the Needle Guide Bracket EZU-PA7C2 Product name Manufacturer Purpose GENERAL PURPOSE Ultra-Pro II™ CIVCO MEDICAL...

  • Page 47: Disposal Of The Probe

    9. Disposal of the probe Recycle or dispose of equipment properly in compliance with your organizational rules and your local laws. CAUTION Before disposing of the equipment, disinfect or take other infection-prevention measures. Disposal of the equipment without taking the proper preventative measures can lead to infection.
  • Page 48 Unit: mm Fig. 23 Dimensions -42- Q1E-EP1457...
  • Page 49 Unit: mm Fig. 24 External view (with the attachment) -43- Q1E-EP1457...
  • Page 50 Unit: mm Fig. 25 Dimensions (with the Needle Guide Bracket) -44- Q1E-EP1457...
  • Page 51 Unit: mm Fig. 26 External view (with Ultra-Pro II Needle Guide / cover kit) -45- Q1E-EP1457...

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