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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.
© Hitachi, Ltd. 2013, 2017. All rights reserved.
Finger ‐ top Probe
EUP‐F531
INSTRUCTION MANUAL
Tokyo, Japan
Q1E‐EP0415‐7
0123
Table of Contents
Related Manuals for Hitachi EUP-F531
Summary of Contents for Hitachi EUP-F531
- Page 1 Finger ‐ top Probe EUP‐F531 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‐EP0415‐7 © 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 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: Q1E-EP0415...
- 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.
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Page 6: Table Of Contents
CONTENTS Page 1. Introduction ················································· 1 1.1. Features ··················································· 1 1.2. Principles of operation ···································· 1 1.3. Intended Use ··············································· 1 1.4. Components ················································· 2 1.5. External View ·············································· 2 2. Inspection before Use ········································ 3 2.1. Inspection for Appropriate Connection ······················ 3 2.2. -
Page 7: Introduction
1. Introduction 1.1. Features The probe of Model EUP-F531 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: Components
Sterilization has not been made to the probe, shipped from the factory. Prior to use of the probe, be sure to clean, disinfect, and sterilize the probe. 1.5. External View The external view of EUP-F531 is shown in Fig.1. Un-immersible part Immersible part (IPX7)/ Applied Part Head... -
Page 9: Inspection Before Use
2. Inspection before Use Prior to use, the probe must be carefully inspected that they are appropriate for use. If not, do not use the probe and immediately contact a service support. 2.1. Inspection for Appropriate Connection 1) Do not attach or connect unauthorized devices nor instruments on the probe, such as unauthorized biopsy attachments. -
Page 10: Operation Procedure
3. Operation Procedure 1) Confirm that the probe is disinfected and sterilized. 2) When connecting probe to or removing it from the scanner, the power of scanner should be put “OFF” without fail. 3) Connect the probe, operate the main unit, and adjust the image according to the instructions given in the operation manual for the main unit. -
Page 11: Cleaning, Disinfection And Sterilization
Application part contacts Disinfection semicritical mucosa (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, EUP-F531 probe is classified as critical. Q1E-EP0415... -
Page 12: 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 4.1. Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after each (Pre-cleaning) -
Page 13: Manual Cleaning And Disinfection
4.3. Manual Cleaning and disinfection Manual cleaning and disinfection Prepare following items before manual cleaning and disinfection: Manual Cleaning a) Detergent: Cidezyme (Johnson & Johnson, #2258) or another cleaning agent with Rinsing after manual approved material compatibility for this cleaning medical device b) Disinfectant: Cidex OPA (Johnson &... -
Page 14: Drying
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 15: Packaging
Packaging 4.6. Packaging Pack the equipment 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 equipment can be placed on plastic mesh wires supplied for plasma sterilization and then packed as mentioned above. - Page 16 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 17: 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 or sterilized according to “4. -
Page 18: Specifications
7. Specifications 7.1. Probe Type: EUP-F531 Center frequency: 6.5MHz Technology: High density Convex Array Probe Dimensions: See Fig. 7 Weight: Approx. 0.6kg (incl. cable and connector) Scanning angle: 100° Probe materials: Bio-compatible allergy free components Acoustic output: According to IEC60601-2-37 (See Main Unit manual.) -
Page 19: Suppliers List
7.2. Suppliers List The products listed below are seriously tested and approved for use with the Convex Array Probe EUP-F531. Product name manufacturer purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incidin Liquid Henkel Hygiene GmbH Disinfectant... - Page 20 29.5 Unit:mm Fig. 7 Dimensions -14- Q1E-EP0415...