Hitachi EUP-L53 Instruction Manual

Linear array probes
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Linear Array Probes
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.
© Hitachi, Ltd. 2013, 2017. All rights reserved.
EUP-L53
EUP-L53S
EUP-L53L
EUP-L52
Tokyo, Japan
Q1E-EP0348-14
0123

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  Summary of Contents for Hitachi EUP-L53

  • 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-EP0348-14 © 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: ( 1 ) Q1E-EP0348...
  • 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 main unit, refer to the operation manual for it. Before using the probe, thoroughly read this manual and keep this book for future reference.
  • 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 Introduction ..........1     1.1   Features ............1   1.2   Principles of operation .......... 1   1.3   Intended Use ............. 2   1.4   Composition ............2   1.5   Accessories (OPTION) ..........2   1.6  ...
  • Page 7: Introduction

    1. Introduction Features The probes of models EUP-L53, L53L, L53S and L52 are Linear Array Electronic Scanning type. The acoustic output of these probes when connected to ultrasound 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 scanner.
  • Page 8: Intended Use

    Intended Use The Linear Array Probes EUP-L53S, L53, L52 and L53L are designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound scanner. Item EUP-L53S EUP-L53 EUP-L53L EUP-L52 Small organ × × × ×...
  • Page 9 1.5.2 Coupler attachment EZU-PA3C1H (Option) (Applicable model: EUP-L53S and L52) By attaching the coupler attachment EZU-PA3C1H, a biopsy through the needle guide besides the function of the EZU-PA3C1 can be made. The optional coupler attachment EZU-PA3C1H components are as follows: Component Model Note...
  • Page 10 1.5.4 Water bag EZU-WL2 (Option) (Applicable model: EUP-L53) By attaching a water bag EZU-WL2 to the probe, better contact with curved region such as mammary gland or thyroid gland can be attained. The optional water bag EZU-WL2 components are as...
  • Page 11 1.5.6 Biopsy Attachment EZU-PA3L (Option) (Applicable model:EUP-L53) The biopsy attachment EZU-PA3L is a dedicated tool for use as mounted on a EUP-L53. The optional biopsy attachment EZU-PA3L components are as follows: Component Note...
  • Page 12: Construction

    This part can be immersed in disinfectant/sterilant solution and can be cleaned by water. Un-immersible part: This part should not be immersed in disinfectant/sterilant solution and also can not be cleaned by water. Fig. 2 External view (EUP-L53, L53L) Q1E-EP0348...
  • Page 13: Introduction

    2. Introduction Prior to use, the probe must be carefully inspected that it is appropriate for use. If not, do not use the probe and the immediately contact a service support. Inspection of appropriate connection 2.1.1 Check that the system is correctly operating. Refer to the instruction manual for the main unit.
  • Page 14: Operation Procedure

    Right-left Right-left orientation mark orientation mark (EUP-L53S,L52) (EUP-L53, L53L) Fig. 3 Relationship between Index Mark and Right-left Orientation Mark When using under sterile condition, protect the probe by using covers. Some Latex material creates allergic reaction. Please use allergy free material covers.
  • Page 15 CAUTION The acoustic lens of the probe is manufactured very thin and delicate to get the high resolution. Therefore, in case of wiping off the ultrasound jelly or cleaning the surface of the acoustic lens, please use a soft cloth or tissue paper and handle with care. (See Fig.
  • Page 16: Reprocessing Procedure

    4. Reprocessing Procedure The probes must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. For reprocessing of the available options for the probes, please refer to the specific instruction manuals of them. ‐ The probes are delivered unsterile. Prior to the first use, reprocess the probes.
  • Page 17 (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, EUP-L53, L53S, L53L, and L52 probes are classified as uncritical. -11- Q1E-EP0348...
  • Page 18 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 -12- Q1E-EP0348...
  • Page 19: Point Of Use (Pre-Cleaning)

    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 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 20 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 21 . 5) for 5 min.) 5) Visually check the outer surface of the probe for leavings of the disinfectant. If necessary, repeat the rinsing. Water Detergent Water Detergent Disinfectant Disinfectant (EUP- L53S, L52) (EUP-L53, L53L) Fig. 5 Immersion of the Probe -15- Q1E-EP0348...
  • Page 22: Drying

    Drying 4.4 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 23 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 24: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 7 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for Tray for sterilization sterilization. Probe in the Pouch Fig.
  • Page 25: Safety Precautions

    6. Safety Precautions WARNING  Never use the probe if the probe head, housing or cable are cracked or damaged.  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.
  • Page 26: Specifications

    7. Specifications Probe Item EUP-L53S EUP-L52 EUP-L53 EUP-L53L Center frequency 7.5MHz 5.5MHz 7.5MHz 7.5MHz Type Linear array probe Technology High density linear array probe See Fig. 11 See Fig. 9 See Fig. 10 Dimensions Weight Approx. 1.5kg (incl. Cable and connector)
  • Page 27: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with the Linear Array Probes (EUP-L53S, L53, L53L and L52). Product name manufacturer purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol Braun Disinfectant HBV-Tücher Incides Henkel Hygiene GmbH Disinfectant Incidin Liquid Henkel Hygiene GmbH...
  • Page 28: Disposal Of The Probe

    8. 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 29 Unit mm Fig. 9 Dimension Diagram of Probe EUP-L53 -23- Q1E-EP0348...
  • Page 30 Unit mm Fig. 10 Dimension Diagram of Probe EUP-L53L -24- Q1E-EP0348...
  • Page 31 Unit mm Fig. 11 Dimension Diagram of Probes EUP-L53S and EUP-L52 -25- Q1E-EP0348...

This manual is also suitable for:

Eup-l53sEup-l53lEup-l52