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Q1E-EP0659

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, dustproof and
dark, dry environment to avoid high
temperature and humidity and direct
sunlight.

«
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3
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6
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Содержание EUP-S50A

Страница 1: ...659 6 Hitachi Ltd 2013 2017 All rights reserved 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 0123 ...

Страница 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 ...

Страница 3: ...questions 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 warnings is ignored CAUTION Caution is used to indicate the presence of a hazard which will ...

Страница 4: ...ol 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 dustproof and dark ...

Страница 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...

Страница 6: ...on 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 9 4 5 Inspection 9 4 6 Packaging 10 4 7 Sterilization 11 4 8 Storage 13 5 Maintenance and Safety Inspection 14 6 Safety Precautions 15 7 Specifications 16 7 1 Probe 16 7 2 Suppliers List ...

Страница 7: ...rasonic waves This system operates under the principles described below 1 When an electric pulse signal is applied from the transmitter to the transducer of the probe the transducer 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 ...

Страница 8: ...on Manual 1 copy Sterilization has not been made to the probe shipped from the factory Prior to use of the probe be sure to clean disinfection and sterilize the probe 1 5 Construction Connector Cable Un immersible part IP40 Fig 1 External View Immersible part IP47 Head Immersible part This part can be immersed in disinfectant solution and also can be cleaned by water Un immersible part This part s...

Страница 9: ...ction for Appropriate Connection 2 1 1 Check that the system is correctly operating Refer to the instruction manual for the Main unit 2 1 2 Do not attach or connect unauthorized devices or instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection for Material Surface 2 2 1 Visually check the surface of the probe head housing and cable for any crack scratch or denaturalization...

Страница 10: ... 2 The right left orientation mark on the image indicates the direction of the index mark on the probe 4 Use under sterile condition protect the probe by using an appropriate cover is recommended Some Latex material may create allergic reaction Please use allergy free material covers 5 After the use of the probe it should be cleaned and disinfected and sterilized then store it in an adequate place...

Страница 11: ...ring 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 responsible...

Страница 12: ...ntainment 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 Disinfection Drying Manual cleaning and disinfection Rinsing afte...

Страница 13: ...ufacturer 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 Please note the minimum contact time of the detergent in the manufacturer s in...

Страница 14: ...2 Confirm the concentration of the 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 The test strips can indicate whether or not the concentration is above the Minimum Effective Concentration MEC Please also note the expiration date of the test stripes Temperature of disinfectant solution should b...

Страница 15: ...ly 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 4 5 Inspection Inspect the equipment for any damage such as crack scratch or deformation Do not use it if any damage is found Water Detergent Disinfectant Fig 3 Immersion of the probe Drying ...

Страница 16: ...ic mesh wires supplied for plasma sterilization and then packed as mentioned above The probe can be packed in a simple or double packing Please note that the size of a sterile barrier should be large enough to be able to pack the equipment leaving sufficient space to seal it completely A sterile barrier should be sealed by an appropriate sealing machine and it is important to confirm that the pack...

Страница 17: ...45 minutes Exposure Temperature 122 0 131 0 F equivalent of 50 55 C Sterilant gas 10 EO 90 HCFC Excess pressure 162 200 kPa Exposure time 120 125 min full cycle Post vacuum 8 26 kPa 2 times Aeration Temperature 50 55 C Time min 11 hours Plasma sterilization Sterilization Method Condition Plasma Sterilization STERRAD 50 100S or 200 Short Cycle Plasma Sterilization Sterrad NX or 100NX Standard cycle...

Страница 18: ...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 TYVEK Pouch Fig 1 Packaging in the pouch Probe TYVEK Pouch Sealed Fig 2 Sealing Probe Fig 3 Packaging in a tray Probe in the Pouch Tray for sterilization ...

Страница 19: ... Q1E EP0659 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 ...

Страница 20: ...ing Disinfection and Sterilization store the probe in a cool and dark space to avoid high temperature humidity and direct sunlight 2 Visually inspect the surface of the probe head the housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use the probe and contact a service support immediately ...

Страница 21: ... By examination of an early pregnancy the exposure time shall be as short as possible Start examination with acoustic output power set to L Low The probe connector is not water proof Do not allow liquid to contact the connector Do not drop hit or bent the probe Use only water detergents and disinfectants in the suppliers list Between use store the probe holder of scanner Under sterile condition us...

Страница 22: ...tem 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 Plasma sterilization Operating conditions Ambient temperature 25 35 C Contact surface tempera...

Страница 23: ...iene Disinfectant GmbH Incidur Spray Henkel Hygiene Disinfectant GmbH STERANIOS 2 ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant Virkon S ANTEC Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plus Johnson Johnson Disinfectant CIDEX OPA Johnson Johnson Disinfectant ALKACIDE ALKAPHARM Disinfectant ALKAZYME ALKAPHARM Cleaner Please contact your local distributor for a current version of the...

Страница 24: ...res Disposal of equipment without taking the proper preventative measures can lead to infection Waste Electrical and Electronic Equipment WEEE Directive The illustration on the right is required by the EU WEEE Directive to appear on all electrical and electronic equipment For proper disposal of this product in an EU nation contact an EU office or agency and observe appropriate local and national r...

Страница 25: ... 19 Q1E EP0659 Unit mm Fig 7 Dimensions E ...

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