Hitachi EUP-OL334 Instruction Manual
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Hitachi EUP-OL334 Instruction Manual

Hitachi EUP-OL334 Instruction Manual

Laparoscopic probe
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Laparoscopic Probe
EUP-OL334
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-EP0304-8
© 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-EP0304-8 © 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-EP0304...
  • Page 3 About this manual Before handling the Laparoscopic Ultrasound probe, read this instruction manual carefully. This instruction manual is intended to provide the ultrasound system user with important information relating to the features, specifications, and proper care of the Laparoscopic Ultrasound probe. This instruction manual presents warnings about possible probe damage that can occur as a result of improper handling and the potential hazards such probe damage presents to patients undergoing a laparoscopic...
  • 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 Probe connector 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 3.

  • Page 6: Table Of Contents

    CONTENTS Page Purpose, Features and Operating Conditions ..... 1 1.1 Purpose ........... 1 1.2 Principles of operation ........1 1.3 Features ..........1 1.4 Operating Conditions ........2 Equipment Composition .......... 2 Component Description .......... 2 Articulating Controls .......... 4 Pre-use Inspection ..........

  • Page 7: Purpose, Features And Operating Conditions

    Purpose This probe has been designed to observe the gallbladder, liver and so on under the laparoscopic operation with it connected to the Hitachi Electronic Ultrasound Scanner. Principles of operation This probe and the ultrasound diagnostic scanner enable image diagnosis using ultrasonic waves.

  • Page 8: Operating Conditions

    Operating Conditions Be sure to observe the following conditions when using this probe: Ambient temperature : +5°C ~ +35°C Relative humidity : 30 ~ 85% Atmospheric pressure : 70 ~ 106hPa Equipment Composition Laparoscopic probe..1 Carrying case....1 Instruction Manual..1 Component Description 6) Right lever 5) Left lever...
  • Page 9 Transducer : Transmits and receives ultrasound. Articulating section : Section to articulate the transducer tip in the up/down plane or right/left plane with the right or left lever. Inserting section : Section that can be inserted into the trocar. Grip section : Section to grip the probe.

  • Page 10: Articulating Controls

    Articulating Controls The control handle section of the probe features two control levers that are used to control the movement and position of the articulating section/transducer. WARNING Never bend or manipulate the articulating section of the probe with your hands or fingers. This can result in severe damage to the articulating mechanism.

  • Page 11: Pre-Use Inspection

    Pre-use Inspection The Laparoscopic Ultrasound probe must be inspected prior to every exam. - By running your fingers about the exterior surfaces of the transducer, articulating section, and rigid shaft, carefully inspect for any signs of mechanical damage such as cracks, cuts, tears, perforations, or protrusions.

  • Page 12: Cleaning, Disinfection And Sterilization

    Cleaning, Disinfection and Sterilization The probe 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 13 Application part contacts semicritical mucosa (intracavitary Disinfection (Disinfectant application) with virucidal effect) Cleaning Application part contacts Disinfection (Disinfectant intracorporeal tissue with virucidal effect - critical directly minimum) (operative application) Sterilization According to the intended use, EUP-OL334 is classified as critical. Q1E-EP0304...

  • Page 14: 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 Q1E-EP0304...
  • Page 15 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 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 16 skirt, face protection mask or protective glasses, see also instructions of the manufacturer for the detergent and the disinfectant) 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).
  • Page 17 and contact time). 2) Confirm the concentration of the disinfectant before immersing the probe. Although Cidex® OPA does not need to be diluted, it is recommended to use test strips to verify the concentration. The test strips can indicate whether or not the concentration is above the Minimum Effective Concentration (MEC).

  • Page 18: Inspection

    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 60°C. Inspection Inspect the equipment for any damage such as crack, scratch or deformation. Do not use it if any damage is found.
  • Page 19 Sterilization Sterilization The probe and accessory can be sterilized using either ethylen oxide gas (EtO) sterilization or plasma sterilization (see table below). Follow the manufacturer's instructions of the sterilizer regarding usage, temperature and sterilization-time. The sterilization method and operating conditions are as follows. Sterilization Method Condition Plasma Sterilization:...
  • Page 20 The packaging before sterilization is as follows. 1) Put the probe into TYVEK pouch. Probe TYVEK Pouch Fig.4 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat sealer. Ensure that the seal is complete. Sealed TYVEK Pouch Probe Fig.5 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for sterilization.

  • Page 21: Sterilization

    Tray for Probe in sterilization the Pouch Fig.6 Packaging in a tray Storage Store the equipment in a cool, dustproof and dark, dry space to avoid high temperature, humidity and direct sunlight. Limitations for the time for sterilized equipment belong to package. Operation Inspection before use Follow “5.
  • Page 22 instruction manual of the ultrasound scanner. Cleaning after use Follow “6. Cleaning, Disinfection and Sterilization” after use. Sterilization Follow “6. Cleaning, Disinfection and Sterilization”. WARNING Never use the probe which transducer and inserting section show any damage such as cracks or cuts, or which cable jacket is broken. If using as it is damaged, electric shock may result.
  • Page 23 CAUTION Connector section of the probe is not watertight. Never pour any liquid to it nor immerse it in any liquid. If neglected, the probe may be damaged. REMINDER The following should be observed before connecting/ disconnecting the probe. If doing so in the state other than the following, malfunction or fault of the equipment may result.

  • Page 24: Maintenance And Safety Inspection

    Maintenance and Safety Inspection Daily visually check the surface of the probe head, Articulating and insertion section housing, cable and connector for any crack, scratch or denaturalization. If you find damage, do not use the probe and immediately contact a service support. Storage For shipping or long-distance transport of the probe, it is strongly recommended that the carrying case provided with the probe be used.

  • Page 25: Specifications

    11. Specifications Laparoscopic Probe Item EUP-OL334 Frequency 7.5MHz Scan system 40R convex Scan angle 40° Cable length 3,000mm Diameter of inserting section 10.0mm Up/down plane : ±90° Articulation Left/right plane : ±90° Trocar/cannula size See CAUTION below. Outside view See Fig. 7.

  • Page 26: Disposal Of The Probe

    12. Disposal of the probe Recycle or dispose of equipment properly in compliance with your organizational rules and your local laws. CAUTION Before disposing of equipment, disinfect or take other infection-prevention measures. Disposal of equipment without taking the proper preventative measures can lead to infection.
  • Page 27 Fig.3 Dimensions -21- Q1E-EP0304...

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