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Sector Scanning Probe
EUP-S70
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-EP1152-6
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123
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Table of Contents
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Summary of Contents for Hitachi EUP-S70
- 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-EP1152-6 © 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: ( 1 ) Q1E-EP1152...
- 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 Medical Device and Probe connector Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.5.
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Page 6: Table Of Contents
CONTENTS Page Introduction ..........1 1.1 Features ............1 1.2 Principles of operation ......... 1 1.3 Intended Use ............ 1 1.4 Composition ............. 2 1.5 Construction ............ 2 Inspection before Use ........ -
Page 7: Introduction
1. Introduction 1.1 Features The probe of model EUP-S70 is a phased array sector scanning type. The acoustic output of this probe when connected to ultrasound scanner was measured according to the IEC 61157 standard. The table of measured acoustic output data is contained in the operation manual of each ultrasound scanner. -
Page 8: Composition
1.4 Composition The probe components of the EUP-S70 are as follows: 1) Probe EUP-S70 ···················· 1 piece 2) Instruction Manual ··············· 1 copy 1.5 Construction Immersible part (IPX7) Head Cable Applied part Connector Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water. -
Page 9: 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 for appropriate connection 2.1.1 Check that the system is correctly operating. Refer to the instruction manual for the main unit. -
Page 10: Operation Procedure
3. Operation Procedure 1) Confirm that the probe is cleaned, disinfected and/or sterilized. 2) Connect the probe, operate the main unit, and adjust the image according to the instructions given in the operation manual for the main unit. 3) Relationship between direction of the probe and the image is shown in Fig. -
Page 11: 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 ‐... - Page 12 (intracavitary (Disinfectant with application) virucidal effect) Cleaning Application part contacts Disinfection intracorporeal tissue (Disinfectant with critical directly virucidal effect - minimum) (operative application) Sterilization According to the intended use, EUP-S70 is classified as uncritical. - 6 - Q1E-EP1152...
- Page 13 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 - 7 - Q1E-EP1152...
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Page 14: 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. - Page 15 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 16 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.
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Page 17: 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 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 18: Sterilization
4.7 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 19 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 Sealed the seal is complete. Probe TYVEK Pouch Fig.
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Page 20: 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 Daily visually check the surface of the probe head, housing, cable and connector for any crack, scratch or denaturalization. -
Page 21: 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 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 22: Specifications
7. Specifications 7.1 Probe Type : EUP-S70 Sector Scanning probe Acoustic working frequency : 3.0MHz Technology : Phased Array Probe Dimensions : See Fig. 7. Weight : Approx. 0.7kg (incl. cable and connector) Scanning angle : 90° Probe materials : Bio-compatible allergy free components... -
Page 23: Suppliers List
7.2 Suppliers List The products listed below are seriously tested and approved for use with the Sector Scanning Probe EUP-S70. Product name Manufacturer Purpose Enzymatic Cidezyme Johnson & Johnson detergent Meliseptol HBV-Tücher Braun Disinfectant Incidin Liquid Henkel Hygiene GmbH Disinfectant... -
Page 24: Disposal Of The Probe
8. Disposal of the probe Recycle or dispose the equipment properly in compliance with your organizational rules and your local Law. 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 25 Unit: mm Fig. 7 Dimensions -19- Q1E-EP1152...