Hitachi S21 Instruction Manual

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S21 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-EP1377-5
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123

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  Summary of Contents for Hitachi S21

  • 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-EP1377-5 © Hitachi, Ltd. 2013,2017. All rights reserved. 0123...
  • Page 2 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-EP1377...
  • 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 1.5...
  • 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 External View ..........3 Inspection before Use ........4 2.1 Inspection for Appropriate Connection ....4 2.2 Inspection for Material Surface ......
  • Page 7: Introduction

    1. Introduction 1.1 Features S21 probe is a phased array sector scanning type probe. The acoustic output of this probe 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 operation manual of each ultrasound scanner.
  • Page 8: Intended Use

    1.3 Intended Use S21 Probe is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound scanner. Cardiac General abdominal organs Transcranial WARNING Never use the probe for following applications. Direct contact to the heart.
  • Page 9: External View

    1.5 External View The external view of S21 Probe is shown in Fig. 1. Immersible part (IPX7) Head Applied part Cable Connector Un-immersible part Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water.
  • Page 10: Inspection Before Use

    2. Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. If not, do not use the probe and immediately contact a service support. 2.1 Inspection of appropriate connection 1) Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner.
  • Page 11: Operation Procedure

    3. Operation Procedure 1) Confirm that the probe is cleaned and disinfected and/or sterilized. 2) 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 12: Cleaning, Disinfection And Sterilization

    4. 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. Temperature should not exceed 60°C during WARNINGS reprocessing Probe connector is not water resistant.
  • Page 13 (intracavitary (Disinfectant with application) virucidal effect) Cleaning Disinfection Application part contacts (Disinfectant with intracorporeal tissue critical virucidal effect - directly minimum) (operative application) Sterilization According to the intended use, S21 probe is classified as uncritical. - 7 - Q1E-EP1377...
  • Page 14 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 - 8 - Q1E-EP1377...
  • Page 15: Point Of Use (Pre-Cleaning)

    4.1 Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after (Pre-cleaning) each use. The procedure is as follows: 1) Remove the probe 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. 3) Wipe the whole surface of the probe with gauze pad and remove superficial visible impurities.
  • Page 16 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). 1) The temperature of the detergent solution should be between 15-30°C, concentration is 1.6%.
  • Page 17 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 18: Drying

    4.4 Drying 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. Alternatively the equipment can be dried using a drying heater at a temperature of less than 60°C.
  • Page 19: Sterilization

    Sterilization The probe 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 Sealed that the seal is complete. Probe TYVEK Pouch Fig.
  • Page 21: Storage

    4.8 Storage Store the equipment in a cool, dustproof, dry, and dark space to avoid high temperature, humidity and direct sunlight. Limitations for the time for sterilized equipment belong to package. 5. Maintenance and Safety Inspection 1) After using the probe, it should be cleaned and disinfected and sterilized according to “4.
  • Page 22: Safety Precautions

    6. Safety Precautions WARNING Never use the probe if the probe head, housing or cable are cracked or damaged. Warning is case of using probe covers which latex is contained The latex may cause such allergic reactions as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, and depression of blood pressure, shock and so on.
  • Page 23: Specifications

    7. Specifications Probe Type : S21 Probe Acoustic working frequency : 3.0MHz Technology : Phased Array Probe Dimensions : See Fig. 7. Weight : Approx. 0.37kg (Including cable and connector) Scanning angle : 90 Probe materials : Biocompatible allergy free...
  • Page 24: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with S21 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 &...
  • Page 25 Unit:mm Fig. 7 Dimensions - 19 - Q1E-EP1377...