Hitachi EUP-F531 Instruction Manual Download Page 4 | Manualshive

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Q1E-EP0415

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

Symbol Descriptive

Content

Manufacturer

Company Name and
Address

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

Authorized

Representative
in The European

Community

Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205

Wiesbaden, Germany

Keep away
from Sunlight

Store the probe in a cool place and

keep away from high temperature,
high humidity, or direct sunlight.

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Summary of Contents for EUP-F531

Page 1: ...nd 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: ...1 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 ...

Page 3: ...stions concerning the manual please contact a service support The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning is used to indicate the presence of a hazard which can cause severe personal injury death or substantial property damage if the warning is ignored CAUTION Caution is used to indicate the presence of a hazard which will or c...

Page 4: ...on of Symbol Symbol Descriptive Content Manufacturer Company Name and Address 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 Authorized Representative in The European Community Hitachi Medical Systems GmbH Otto von Guericke Ring 3 D 65205 Wiesbaden Germany Keep away from Sunlight Store the probe in a cool place and...

Page 5: ...ltage Probe connector Caution Biohazard Probe connector Follow the instruction manual to operate this instrument If not avoided may result in injury property damage or the equipment trouble Probe connector STERRAD sterilization compatibility mark Probe connector Upper Limit of Temperature The probes that are applicable to Ethylene Oxide Gas Sterilization use symbol of Upper Limit of Temperature 55...

Page 6: ...ion for Material Surface 3 3 Operation Procedure 4 4 Cleaning Disinfection and Sterilization 5 4 1 Point of use Pre cleaning 6 4 2 Containment and transportation 6 4 3 Manual Cleaning and disinfection 7 4 4 Drying 8 4 5 Inspection 8 4 6 Packaging 9 4 7 Sterilization 9 4 8 Storage 11 5 Maintenance and Safety Inspection 11 6 Safety Precautions 11 7 Specifications 12 7 1 Probe 12 7 2 Suppliers List 1...

Page 7: ...er converts electric signals into mechanical vibration energy for emitting pulse shaped ultrasonic waves into the body part liquid or other medium contacting the transducer 2 The emitted ultrasonic waves are reflected by boundaries with different acoustic characteristics acoustic impedance within the body 3 The transducer is also used to receive reflected ultrasonic waves The transducer vibrates m...

Page 8: ...o clean disinfect and sterilize the probe 1 5 External View The external view of EUP F531 is shown in Fig 1 Immersible part 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 cannot be cleaned by water Fig 1 External view Immersible part IPX7 Applied Part Un immersible part Cable ...

Page 9: ...h or connect unauthorized devices nor instruments on the probe such as unauthorized biopsy attachments 2 Check that the system is correctly operating Refer to the instruction manual for the main unit 2 2 Inspection for Material Surface Visually inspect the surface of the probe and head housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use t...

Page 10: ... may create allergic reaction Please use allergy free material covers 6 After use of the probe it should be cleaned and disinfected and sterilized then store it in an adequate place 1 Acoustic jelly attached to the scanner as one of accessories is not sterilized So in case the probe is to be used during the surgical operation or in body cavities never apply that jelly to the probe 2 In case the pr...

Page 11: ...uring transportation Levels of reprocessing requirements Depending on the application of the product and with regard to risk evaluation the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as uncritical semi critical or critical Supporting information concerning this topic is listed in the table below The user is responsibl...

Page 12: ...ith gauze pad and remove superficial visible impurities 4 2 Containment and transportation Putting the contaminated equipment into exclusive shock and damage proof container for transportation is recommended It is recommended that instruments are reprocessed as soon as possible and not later than 4 hours after usage Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning Manual Dis...

Page 13: ...30 C concentration is 1 6 Please note the minimum contact time of the detergent in the manufacturer s instruction If a differing detergent is used please also note the approved material compatibility for the medical device 2 Immerse the immersible part of the probe without connector into the diluted detergent solution see Figure 3 Wipe the immersible part of the probe under the surface of the dete...

Page 14: ...material compatibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 3 Set a clock to insure the recommended contact time which is 5 minutes 4 Rinse the immersible part of the probe with deionized water for 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water see Fig 3 for 5 min 5 Visually check the ...

Page 15: ...ed 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 STERRAD 50 100S or 200 Short Cycle Plasma Sterilization Sterrad NX or 100NX Standar...

Page 16: ...Seal the TYVEK Pouch using a heat sealer Ensure that the seal is complete 3 Put the sealed pouch into a tray or plastic mesh wire for sterilization Probe TYVEK Pouch Fig 4 Packaging in the pouch TYVEK Pouch Sealed Probe Fig 5 Sealing Fig 6 Packaging in a tray Probe in the Pouch Tray for sterilization ...

Page 17: ...racked 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 and depression of blood pressure shock and so on For the patients suspected of latex allergy do not use the latex containing medical devices If you observe any of above mentioned symptoms in your patient during...

Page 18: ...le system Depending on production and upgrade status For detailed information contact a service support Classification MDD classification IIa Cleaning Applicable detergents are listed in the suppliers list Disinfection Applicable disinfectants are listed in the suppliers list Sterilization ETO gas sterilization Operating conditions Ambient temperature 25 35 C Contact surface temperature temperatur...

Page 19: ...on Virkon S Antec Disinfectant ALKAZYME ALKAPHARM Cleaner Please contact your local distributor for a current version of the Disinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 8 Disposal of the probe Recycle or dispose of equipment properly in compliance with your organizational rules and your local laws Before disposing of equipment disinfect or take other inf...

Page 20: ... 14 E Q1E EP0415 Unit mm Fig 7 Dimensions 21 29 5 2200 16 150 60 65 ...

Page 21: ......

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