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Hitachi EUP-O732T Instruction Manual

Intraoperative probe
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Intraoperative Probe
EUP-O732T
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-EP1234-7
© Hitachi, Ltd. 2013,2017. All rights reserved
0123

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Summary of Contents for Hitachi EUP-O732T

  • 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-EP1234-7 © 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 Hitachi Medical Systems GmbH Representative: 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-EP1234...
  • Page 3 About this manual This instruction manual contains safety precautions, the inspection, the operation procedure and the reprocessing procedure of EUP-O732T. Please read this manual thoroughly to ensure the safety operation. If you have any questions concerning the operation of the probe, please contact a service support.
  • 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

    Inspection for Appropriate Connection ··············· 4 Inspection for Material Surface ····················· 4 3. Operation Procedure ···································· 5 4. Option of EUP-O732T ···································· 7 Magnetic Sensor (EZU-RV2S) ·························· 7 Magnetic Sensor (EZU-RV3S) ·························· 9 5. Cleaning and Disinfection and Sterilization ············ 12 Point of use (Pre-cleaning) ·························...

  • Page 7: Introduction

    1. Introduction 1.1 Features The Intraoperative Probe EUP-O732T is a probe for Convex Array electronic scanning. The acoustic output of this probe when connected to ultrasound scanner was measured according to IEC 60601-2-37 standard. The table of measured acoustic output data is contained in the operation manual of each ultrasound scanner.

  • Page 8: Intended Use

    1.3 Intended Use The Intraoperative Probe EUP-O732T is designed for observation and diagnosis of the following regions mainly by connecting with the HITACHI ultrasound scanner. Intraoperative  WARNING Never use the probe for following regions. 1) The heart (Do not contact directly.) 2) The eyeball 1.4 Compositions...

  • Page 9: External View

    1.6 External View The external view of EUP-O732T is shown in Fig.1. Immersible part (IPX7) Probe housing Scan Cable head Connector Applied part Magnetic sensor attachment(Option) Spacer for EZU-RV2S (Option) Immersible This part can be immersed in disinfectant part: solution and also can be cleaned by water.

  • Page 10: Inspection Before Use

    2. Inspection before Use Prior to use, the probe and accessories must be carefully inspected so that they are appropriate for use. If you find any damage, do not use them and contact a service support immediately. 2.1 Inspection for Appropriate Connection 1) Confirm that the system is correctly operating.

  • Page 11: Operation Procedure

    The Magnetic sensor attachment and the Spacer for EZU-RV2S are needed for Real-time Virtual Sonography (RVS). Regarding the option for RVS, please refer to “4.Option of EUP-O732T”. 2) It is recommended to use a disposable probe cover for preventing a patient from infection and the probe cover should be allergy free material to avoid allergic reaction.
  • Page 12 6) After the use of the probe, clean and disinfect and sterilize the probe immediately and using RVS, also clean and disinfect and sterilize the Magnetic sensor attachment. In case of using RVS with an EZU-RV2S, also clean and disinfect and sterilize the Spacer for EZU-RV2S.

  • Page 13: Option Of Eup-O732T

    There are two types of the magnetic sensors for EUP-O732T, EZU-RV2S and EZU-RV3S. EZU-RV2S and EZU-RV3S are shown in Fig.3 and Fig.8. The uses of EUP-O732T with wither of the magnetic sensors enables the user to perform RVS (Real-time Virtual Sonography).
  • Page 14 CAUTION 1) Never attach the magnetic sensor attachment to the probe in the incorrect direction, otherwise result false diagnosis. 2) Never forget to attach the Spacer for EZU-RV2S when using RVS with magnetic sensor EZU-RV2S, otherwise it may result in false diagnosis.

  • Page 15: Magnetic Sensor (Ezu-Rv3S)

    Spacer for EZU-RV2S before the first use as they are not sterilized in the factory. 4.2 Magnetic Sensor (EZU-RV3S) Magnetic sensor (EZU-RV3S) as shown in Fig.8 is the magnetic sensor for EUP-O732T. Direction mark Magnetic Sensor (EZU-RV3S: white) Fig.8 Magnetic sensor (EZU-RV3S)
  • Page 16 a) Insert Magnetic sensor into the Magnetic sensor attachment with the correct direction as shown in Fig.9. Direction mark Magnetic sensor of EZU-RV3S attachment Direction mark of EZU-RV3S Magnetic sensor (EZU-RV3S: White) Fig.9 How to attach the Magnetic sensor CAUTION Never attach the magnetic sensor attachment to the probe in the incorrect direction;...
  • Page 17 4.2.2 How to Release the Magnetic Sensor The procedure of releasing the Magnetic sensor is as follow. 1) Detach the Magnetic sensor attachment from the probe as shown Fig.11 in the out of operative field. Fig.11 How to release the Magnetic sensor attachment from the probe 2) Detach the magnetic sensor from the Magnetic sensor attachment as shown Fig.12 in the out of operative field.

  • Page 18: Cleaning And Disinfection And Sterilization

    5. Cleaning and Disinfection and Sterilization The probe and accessory 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 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, EUP-O732T probe is classified as critical. -13- Q1E-EP1234...
  • 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-EP1234...

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

    (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A) EUP-O732T probe 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 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) EUP-O732T probe 1) The temperature of the detergent solution should be between 15-30 °C, concentration is 1.6%. Please note the minimum...
  • Page 23 5) Visually check the outer surface of the Attachment for cleanness. If necessary, use magnifying glass for visually check. If there is still soil visible, repeat all above steps. Manual disinfection: A) EUP-O732T probe 1) Prepare the disinfectant solution in a tank with cold water (please follow...

  • Page 24: Drying

    4) Visually check the outer surface of the Attachment for leavings of the disinfectant. If necessary, repeat the rinsing. Drying 5.4 Drying 1) Wipe the probe with a single-use, fluff-free wipe or towel to remove moisture from the surface of the probe. 2) Dry the probe naturally in an ambient temperature between 15-30°C for a minimum of 4 hours.
  • Page 25 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 26: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Probe Attachment Fig. 15 Sealing 3) Put the sealed pouch into a tray plastic mesh wire Tray for sterilization. sterilization Probe in the Pouch Fig.

  • Page 27: Maintenance And Safety Inspection

    6. Maintenance and Safety Inspection 6.1 Daily Inspection 1) Visually inspect the surface of the probe head, housing, cable and connector for any crack, scratch or denaturalization. If you find any damage, do not use the probe and contact a service support immediately.

  • Page 28: Safety Precautions

    The ultrasound gel attached to the ultrasound scanner as one  of accessories is not sterile so never use it with EUP-O732T. Do not attempt to disassemble, modify, or repair the probe.  Electric shock or other unforeseen accidents could result.
  • Page 29 CAUTION Keep the acoustic power low and minimize the ultrasound  exposure time for the examination of an early pregnancy. Do not expose the connector to water or other liquids. The  connector is not waterproof. Do not hit or drop the probe. The probe is easily damaged ...

  • Page 30: Specifications

    8. Specifications 8.1 Probe Type: EUP-O732T Intraoperative probe Acoustic working frequency: 7.5MHz±30% Technology: Convex Array Probe Dimensions: See Fig.17 Weight: Approx. 0.65kg (Including cable and connector) Probe materials: Biocompatible allergy free components Acoustic output: According to IEC 60601-2-37 (See Main Unit manual)

  • Page 31: Supplier's List Of The Probe

    8.2 Supplier’s List of the Probe The products listed below are seriously tested and approved for use with the Intraoperative Probe EUP-O732T. Product name Manufacturer Purpose ENZOL™ Johnson&Johnson Cleaner Cidex® OPA Johnson&Johnson Disinfectant Detergicide® BIOMARK Disinfectant PERASAFE™ DuPont Disinfectant CIV-Flex™ Covers 610-575 CIVCO Probe cover 8.3 Supplier’s List of the Magnetic Sensor Attachment and the...

  • Page 32: Disposal Of The Probe

    9. Disposal of the Probe Recycle or dispose of equipment properly in compliance with your organizational rules and your local laws. CAUTION Before disposing of the equipment, disinfect or take other infection-prevention measures. Disposal of the equipment without taking the proper preventative measures can lead to infection. Waste Electrical and Electronic Equipment (WEEE) Directive The illustration on the right is required by WEEE...
  • Page 33 Unit: mm Fig.17 Dimensions -27- Q1E-EP1234...
  • Page 34 Unit: mm Fig.18 External view of the probe EUP-O732T with the Magnetic Sensor Attachment (Option) -28- Q1E-EP1234...

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