Hitachi L34 Instruction Manual
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Hitachi L34 Instruction Manual

Hitachi L34 Instruction Manual

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L34 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-EP1361-7
© Hitachi, Ltd. 2013,2017. All rights reserved..
0123

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  • 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-EP1361-7 © 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-EP1361...
  • 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

    CONTENTS Page Introduction ........... 1 1.1 Features ............1 1.2 Principles of operation ..........1 1.3 Intended Use ............2 1.4 Components ............2 1.5 Option .............. 3 1.6 External View ............4 Inspection before Use .......... 5 2.1 Inspection for Appropriate Connection ....... 5 2.2 Inspection for Material Surface ........

  • Page 7: Introduction

    This probe is categorized in class Ⅱa according to Directive 93/42/EEC. According to IEC 60601-1, L34 Probe is classified as type BF. Principles of operation This probe and the ultrasound diagnostic scanner enable image diagnosis using ultrasonic waves.

  • Page 8: Intended Use

    Intended Use L34 Probe is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound diagnostic scanner.  Small organ  Peripheral Vessel  Pediatric  Abdominal  Biopsy (with coupler attachment) WARNING Never use the probe for following applications.
  • Page 9 Option 1.5.1 Coupler attachment EZU-PA3C1 (Option) By attaching the coupler attachment EZU-PA3C1, detecting of the blood flow in the shallow blood vessel is possible, by keeping a suitable angle. The optional coupler attachment EZU-PA3C1 components are as follows: Component Model Note EZU-PA3C1 Coupler attachment...

  • Page 10: External View

    External View The external view of L34 Probe is shown in Fig. 1 Immersible part (IPX7) Cable Head Applied part 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. If you find any damage, do not use the probe immediately contact a service support. Inspection for appropriate connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner.

  • Page 12: Operation Procedure

    Operation Procedure Confirm that the probe is cleaned, 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. Confirm the direction of the probe.
  • 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: Reprocessing Procedure

    Reprocessing Procedure The probe must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. For reprocessing of Coupler attachment EZU-PA3C1, PA3C1H and PA3C2, refer to the instruction manual of each Coupler attachment. ‐ The probe is delivered unsterile. Prior to the first use, reprocess the probe.
  • Page 15 Application part contacts Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Disinfection Application part contacts (Disinfectant with critical intracorporeal tissue directly virucidal effect - (operative application) minimum) Sterilization According to the intended use, EUP-L34 is classified as uncritical. Q1E-EP1361...
  • Page 16 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 -10- Q1E-EP1361...

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

    4.1 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 and any coupler attachments. 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 18 Manual Cleaning: Prepare the detergent solution in a tank with cold water (please follow the instructions of the detergent manufacturer regarding application, dilution and contact time). 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 19 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 probe.

  • Page 20: Drying

    Drying Drying 1) Wipe the probe 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 21 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 22: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 6 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for sterilization Probe in the Pouch Fig.

  • Page 23: Maintenance And Safety Inspection

    Maintenance and Safety Inspection After using the probe, it should be cleaned and disinfected and/or sterilized according to “4. Reprocessing Procedure”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight. Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization.

  • Page 24: 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 25: Specifications

    Specifications Probe Type : L34 Probe Acoustic working frequency : 5.0MHz Technology : High density linear array probe Dimensions : See Fig. 8 Weight : Approx. 0.44kg (incl. cable and connector) Probe Material : Bio-compatible allergy free components Acoustic output : According to IEC60601-2-37 (See Main Unit manual.)

  • Page 26: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with L34 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 27 Unit:mm Fig. 8 Dimensions -21- Q1E-EP1361...

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