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Convex Array Probe
EUP-C524
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-EP0385-6
© Hitachi, Ltd. 2013,2016. All rights reserved.
0123
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Summary of Contents for Hitachi EUP-C524
- 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-EP0385-6 © Hitachi, Ltd. 2013,2016. 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 Ultrasound Logistics, Zweigniederlassung der Hitachi Medical Systems Europe Holding AG Carl-Zeiss-Strasse 5, D-72555 Metzingen, Germany EU Importer: Hitachi Medical Systems Europe Holding AG Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland...
- 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 Probe connector 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.6.
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Page 6: Table Of Contents
CONTENTS Page General ························································ 1 1.1 General ····························································· 1 1.2 Principles of operation ············································· 1 1.3 Intended Use ························································ 2 1.4 Composition ························································· 2 1.5 Option ······························································ 2 1.6 External View ······················································· 3 Inspection before Use ·········································· 4 2.1 Inspection for Appropriate Connection ······························· 4 2.2 Inspection for Material Surface ·····································... -
Page 7: General
General General The probe of Model EUP-C524 is Convex Array electronic scanning type. 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
Intended Use The Convex Array Probe EUP-C524 is designed for observation and diagnostic mainly of the following regions by connecting with the HITACHI ultrasound scanner. Abdominal Pediatrics Fetal Small organ Composition The probe components of the EUP-C524 are as follows: Probe EUP-C524...1 piece... -
Page 9: External View
This part can be immersed in disinfectant solution and also can be cleaned by water. Un-immersible part: This part should not be immersed in disinfectant solution and also can not be cleaned by water. Fig.1 External view of the EUP-C524 Q1E-EP0385... -
Page 10: Inspection Before Use
Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. Inspection for Appropriate Connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner. 2.1.2 Do not attach or connect unauthorized devices or instruments on the probe, such as unauthorized biopsy attachments. -
Page 11: Operation Procedure
Operation Procedure Confirm that the probe is disinfected and sterilized. Connect the probe, operate the Main unit, and adjust the image according to the instructions given in the operation manual for the Main unit. Relationship between direction of the probe and the image is shown in Fig.2. -
Page 12: Cleaning, Disinfection And Sterilization
Cleaning semicritical mucosa (intracavitary Disinfection (Disinfectant application) with virucidal effect) Cleaning Application part contacts Disinfection (Disinfectant intracorporeal tissue critical with virucidal effect - directly minimum) (operative application) Sterilization According to the intended use, EUP-C524 probe is classified as uncritical. Q1E-EP0385... -
Page 13: Point Of Use (Pre-Cleaning)
The flowchart of the reprocessing process of this probe is as follows. Manual cleaning and disinfection Drying Point of use Manual Cleaning (Pre-cleaning) Packing Rinsing after manual Containment and cleaning transportation Sterilization Manual Disinfection Rinsing after manual disinfection Point of use (Pre-cleaning) Point of use (Pre-cleaning) Pre-cleaning should be done immediately... -
Page 14: Cleaning And Disinfection
Cleaning and disinfection Manual cleaning and disinfection Prepare following items before manual cleaning and disinfection: Manual Cleaning a) Detergent: Cidezyme (Johnson & Rinsing after manual Johnson, #2258) or another cleaning cleaning agent with approved material compatibility this medical Manual Disinfection device b) Disinfectant: Cidex OPA (Johnson &... - Page 15 3) The immersible part of the probe should be left in the detergent solution according to the specified contact time of the detergent manufacturer. 4) Wipe the un-immersible parts of the probe with a soft cloth dipped with the detergent solution. 5) Rinse the probe with running tap water for 1 minute.
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Page 16: Drying
Manual disinfection: 1) Prepare the disinfectant solution in a tank with cold water (please follow instructions disinfectant manufacturer regarding application, concentration, microbiological efficiency, service life and contact time). 2) Confirm concentration 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. -
Page 17: Packaging
Packaging Packaging Pack the probe in a sterile barrier such as Polypropylene fleece or transparent package made from Polyethylene film and Tyvek®, and then place it into a tray. The tray should be also covered with a sterile barrier. Additionally the probe can be placed on plastic mesh wires supplied for plasma sterilization and then packed as mentioned above. -
Page 18: 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. ETO Gas Sterilizer, closed system ... - Page 19 The packaging before sterilization is as follows. 1) Put the probe into TYVEK pouch. Probe TYVEK Pouch Fig. 1 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat sealer. Ensure that the Sealed seal is complete. Probe TYVEK Pouch Fig.
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Page 20: Storage
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. -14- Q1E-EP0385... -
Page 21: Maintenance And Safety Inspection
Maintenance and Safety Inspection After using the probe, it should be cleaned and disinfected or sterilized according to “4. Cleaning, Disinfection and Sterilization”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight. Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization. -
Page 22: Safety Precautions
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 23: Specifications
Specifications Probe Type : EUP-C524 Convex Array Probe Center frequency : 5.0MHz Technology : High density Convex Array Probe Dimensions : See Fig.7 Weight : Approx. 1.0kg (incl. cable and connector) Scanning angle : 66° Probe materials : Bio-compatible allergy free components... -
Page 24: Suppliers List
Suppliers List The products listed bellow are seriously tested and approved for use with the Convex Array Probe EUP-524. Product name manufacturer purpose Enzol Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant CIDEX plus Johnson & Johnson Disinfectant ALKACIDE ALKAPHARM Disinfectant ALKAZYME... - Page 25 Unit:mm Fig.7 Dimensions -19- Q1E-EP0385...