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Hitachi L55 Probe Instruction Manual

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L55 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-EP1368-6
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123
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Summary of Contents for Hitachi L55 Probe

  • 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-EP1368-6 © 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 Representative: Hitachi Medical Systems GmbH Otto-von-Guericke-Ring D-65205 Wiesbaden, Germany EU Importer: Hitachi Medical Systems Europe Holding AG Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland Local Distributor: Q1E-EP1368...
  • 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

    Inspection before Use .......... 5 2.1 Inspection for appropriate connection ..............5 2.2 Inspection for material surface ................5 Operation Procedure ..........6 Option of L55 Probe ..........8 4.1 Elasto Coupler ........................8 4.2 Magnetic sensor ........................9 Reprocessing Procedure ........12 5.1 Point of use (Pre-cleaning) ..................

  • Page 7: General

    General General L55 Probe is a Linear Array Probe. The acoustic output of L55 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 L55 Probe is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner.  Mammary gland  Thyroid  Superficial organs WARNING Never use the probe for following applications.  Direct contact to the heart.
  • Page 9 Option 1.4.1 Elasto Coupler 1.4.2 Needle Guide Bracket EZU-PA7L2 Needle guide bracket········ 1 piece Brush······················· 1 piece Spring(Spare)··············· 2 pieces Instruction manual·········· 1 copy Case························ 1 piece Please refer to the instruction manual of EZU-PA7L2 about the method of handling, cleaning and sterilizing the needle guide bracket EZU-PA7L2.

  • Page 10: External View

    External View The external view of L55 Probe is shown in Fig. 1. Immersible part (IPX7) Head Applied part Cable Elasto coupler (Option) Magnetic sensor Connector attachment （Option） 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 of 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, the magnetic sensor attachment and the elasto coupler are cleaned and disinfected and/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 Using a sterile probe cover to protect the probe is recommended. 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 desire image.

  • Page 14: Option Of L55 Probe

    Option of L55 Probe Elasto Coupler 4.1.1 How to attach the Elasto Coupler To use elastography, attach the elasto coupler as shown below. Attach the elasto coupler on the probe as straight as possible as shown in Fig. 3. Elasto coupler Fig.

  • Page 15: Magnetic Sensor

    Magnetic sensor 4.2.1 How to attach the Magnetic sensor The procedure of attaching the magnetic sensor is as follows. 1) Confirm that the probe and the magnetic sensor attachment are cleaned, disinfected and/or sterilized. 2) 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 16 Projected part of the Magnetic sensor attachment Fit the insertion direction Index mark Fig. 6 How to attach the Magnetic sensor attachment CAUTION Never attach the magnetic sensor attachment to the probe at the incorrect direction, otherwise it may result in false diagnosis. 4.2.2 How to release attach the Magnetic sensor The procedure of releasing the magnetic sensor is as follows.
  • Page 17 2) Release the magnetic sensor from the magnetic sensor attachment as shown Fig. 8 Fig. 8 How to release the Magnetic sensor from the Magnetic sensor attachment -11- Q1E-EP1368...

  • Page 18: Reprocessing Procedure

    Reprocessing Procedure The probe and accessories must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. For reprocessing of the needle guide bracket EZU-PA7L2 refer to the instruction manual of the needle guide bracket. The probe is delivered unsterile. Prior to the first use, reprocess the probe.
  • Page 19 Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Application part contacts Disinfection intracorporeal tissue (Disinfectant with critical directly (operative virucidal effect - application) minimum) Sterilization According to the intended use, L55 probe is classified as uncritical. -13- Q1E-EP1368...
  • Page 20 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 -14- Q1E-EP1368...

  • Page 21: Point Of Use (Pre-Cleaning)

    Pre-cleaning should be done immediately after each use. (Pre-cleaning) The procedure is as follows: A) L55 probe 1) Remove the probe cover and any accessories from the probe. 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 22 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) L55 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 23 Manual disinfection: A) L55 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 24 Water Detergent Disinfectant Fig. 9 Immersion of the probe, the magnetic sensor attachment and the elasto coupler -18- Q1E-EP1368...

  • Page 25: 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 26 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 27: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 11 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for Tray for sterilization sterilization. Probe in the Pouch Fig.

  • Page 28: Maintenance And Safety Inspection

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

  • Page 29: 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 30: Specifications

    Specifications Probe Type : L55 Probe Acoustic working frequency : 7.5MHz Technology : Linear Array Probe Dimensions : See Fig. 13. Weight : Approx. 0.46kg (incl. cable and connector) Scanning width : 50mm Probe materials : Bio-compatible allergy free components...

  • Page 31: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with L55 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 & Johnson Disinfectant CIDEX®...
  • Page 32 Unit:mm Fig. 13 Dimensions -26- Q1E-EP1368...
  • Page 33 Fig. 14 External View (with the Elasto coupler) Fig. 15 External View (with the Magnetic sensor attachment) -27- Q1E-EP1368...

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