Hitachi C42 Instruction Manual
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Hitachi C42 Instruction Manual

Hitachi C42 Instruction Manual

Probe
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C42 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-EP1359-6
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123
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Summary of Contents for Hitachi C42

  • Page 1 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-EP1359-6 © 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/in dex.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-EP1359...
  • Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, 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 Medical Device Probe connector and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.6.

  • Page 6: Table Of Contents

    2.1   Inspection for Appropriate Connection ....... 5   2.2   Inspection for Material Surface ........5   Operation Procedure ..........6     Option of C42 Probe ..........8     4.1   Magnetic sensor ............. 8   Reprocessing Procedure ........13  ...

  • Page 7: General

    General General C42 Probe is a Convex Array Probe. The acoustic output of C42 Probe was measured according to the IEC60601-2-37 standard and the measurement was conducted by operating with the Hitachi ultrasound diagnostic scanner. The measured acoustic output is listed in the instruction manual of the Hitachi ultrasound diagnostic scanner.

  • Page 8: Intended Use

    Intended Use C42 Probe is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner.  Neonatal  Pediatrics  Intra-operative Components The components of C42 Probe are given below: Probe ........1 piece Instruction manual .....
  • Page 9 CAUTION A biopsy should be performed only by a well-trained physician. Use only the authorized needle guide bracket for performing a biopsy. CAUTION Confirm that the name of the needle guide bracket to be attached to the probe corresponds to the name of the bracket displayed on the monitor.

  • Page 10: External View

    External View The external view of C42 Probe is shown in Fig. 1. Cable Magnetic sensor attachment (Option) Magnetic sensor attachment (with needle guide bracket) (Option) Connector Un-immersible part Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water.

  • Page 11: Inspection Before Use

    Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. Inspection for Appropriate Connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner. 2.1.2 Do not attach or connect unauthorized devices or instruments on the probe, such as unauthorized biopsy attachments.

  • Page 12: Operation Procedure

    Operation Procedure Confirm that the probe and the magnetic sensor attachment are cleaned, disinfected or sterilized. 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 13 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. Place the probe on the examination site and adjust the probe’s position for a clear view of the desired image.

  • Page 14: Option Of C42 Probe

    Option of C42 Probe Magnetic sensor 4.1.1 How to attach the Magnetic sensor The procedure of attaching the magnetic sensor is as follow. 1) Confirm that the probe and magnetic sensor attachment are cleaned, disinfected or sterilized. Connect the probe, operate the ultrasound diagnostic scanner, and adjust the image according to the instructions given in the operation manual for the ultrasound diagnostic scanner.
  • Page 15 b) Insert the magnetic sensor into the magnetic sensor attachment with correct direction as shown in Fig. 4. When not using the Needle guide bracket Magnetic sensor attachment Direction mark of the Magnetic sensor Magnetic sensor (Place the direction mark upward as shown here.) Fit the insertion direction Projected part of the Magnetic sensor attachment...
  • Page 16 Place the magnetic sensor attachment on the probe with the correct direction as shown in Fig. 5. When not using a Needle Guide Bracket When using a Needle Guide Bracket Slit of the Projected part of Magnetic sensor the Magnetic sensor attachment attachment Fit the insertion...
  • Page 17 4.1.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor from the probe is as follows. a) Push the magnetic sensor attachment and release it from the probe as shown in Fig. 6. When not using a Needle Guide Bracket When using a Needle Guide Bracket Push here Push here...
  • Page 18 b) Release the magnetic sensor from the magnetic sensor attachment as shown in Fig. 7. When not using the Needle guide bracket When using the Needle guide bracket How to release the magnetic sensor Fig. 7 -12- Q1E-EP1359...

  • Page 19: Reprocessing Procedure

    Reprocessing Procedure The probe and magnetic sensor attachment must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. Take care about clean circumstances before using the probe and the magnetic sensor attachment on the next patients. Please refer to the instruction manual of needle guide bracket EZU-PA532 about the method of cleaning, disinfecting and sterilizing the needle guide bracket EZU-PA532...
  • Page 20 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 21 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 -15- Q1E-EP1359...

  • Page 22: Point Of Use (Pre-Cleaning)

    5.1 Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after each use. (Pre-cleaning) The procedure is as follows: 1) Remove the probe 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 23 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) C42 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 24 If necessary, use magnifying glass for visually check. If there is still soil visible, repeat all above steps. Manual disinfection: A) C42 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).
  • Page 25 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. 8). Set a clock to insure the recommended contact time which is 5 minutes.

  • Page 26: Drying

    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 probe naturally in an ambient temperature between 15-30°C for a minimum of 4 hours. Alternatively the probe can be dried using a drying heater at a temperature of less than 60°C.
  • Page 27 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 28: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 10 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for sterilization Probe in the Pouch Fig.

  • Page 29: Maintenance And Safety Inspection

    Maintenance and Safety Inspection After using of the probe and the magnetic sensor attachment, they should be cleaned and disinfected or sterilized according to “5. Reprocessing Procedure”, then store the probe and the magnetic sensor attachment in a cool and dark space to avoid high temperature, humidity and direct sunlight.

  • Page 30: Safety Precautions

    Safety Precautions WARNING  Never use the probe if the probe head is damaged.  Do not use the latex probe cover for latex sensitive patients. The probe cover, which contains latex, may cause allergic reactions such as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, depression of blood pressure, and shock.

  • Page 31: Specifications

    Specifications Probe Type : C42 Probe Acoustic working frequency : 6.5MHz Technology : Convex Array Probe Dimensions : See Fig. 12 Weight : Approx. 0.44kg (incl. cable and connector) Scanning angle : 80° Probe materials : Bio-compatible allergy free components...

  • Page 32: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with C42 Probe. Product name manufacturer purpose ® Cidezyme Johnson & Johnson Enzymatic detergent STERANIOS 2% ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant CIDEX Johnson & Johnson Disinfectant ®...

  • Page 33: Disposal Of The Probe

    Disposal of the probe Recycle or dispose the equipment properly in compliance with your organizational rules and your local laws. CAUTION Before disposing the equipment, disinfect or take other infection-prevention measures. Disposal of the equipment without taking the proper preventative measures can lead to infection.
  • Page 34 Unit:mm Fig. 12 Dimensions -28- Q1E-EP1359...
  • Page 35 Fig. 13 External view (with the Magnetic sensor attachment) Fig.14 External view (with the Magnetic sensor attachment and the Needle guide bracket) -29- Q1E-EP1359...

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