Hitachi EUP-L54MA Instruction Manual Download Page 2

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Q1E-EP0995

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:

Summary of Contents for EUP-L54MA

Page 1: ...95 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 ...

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: ...estions 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 ...

Page 4: ... 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 ...

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: ...Inspection for Material Surface 3 3 Operation Procedure 4 4 Reprocessing Procedure 5 4 1 Point of use Pre cleaning 8 4 2 Containment and transportation 8 4 3 Manual Cleaning and disinfection 8 4 4 Drying 11 4 5 Inspection 11 4 6 Packaging 11 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 17 8 Di...

Page 7: ...d 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 boundaries with different acoustic characteristics acoustic impedance within the body 3 The transducer is also us...

Page 8: ...y Prior to use of the probe be sure to clean disinfect and sterilize the probe 1 5 External View The external view of EUP L54MA is shown in Fig 1 Immersible part IPX7 Head Un immersible part 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 can not be cleaned by w...

Page 9: ...struction 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 2 2 Inspection of material surface 2 2 1 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 the probe and contact...

Page 10: ...ge is shown in Fig 2 The right left orientation mark on the image indicates the direction of the index mark on the probe 4 Under sterile condition protect the probe by using covers 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 or sterilized then store it in an adequate place Fig 2 Relations...

Page 11: ...reprocessing Probe connector is not water resistant Limitations on reprocessing The probe is not completely submersible The immersible part is shown in Fig 1 The un immersible part should be disinfected by wipe disinfection Transportation before using The probe should be packed in a sterile pouch or container to transport from Central Sterile Supply Department CSSD to an operating room Be careful ...

Page 12: ...w The user is responsible for correct classification of the medical device Classification Definition Processing uncritical Application part only contacts intact and uninjured skin Cleaning Disinfection semicritical Application part contacts mucosa intracavitary application Cleaning Disinfection Disinfectant with virucidal effect critical Application part contacts intracorporeal tissue directly ope...

Page 13: ...ocess of this probe is as follows Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning Manual Disinfection Drying Manual cleaning and disinfection Rinsing after manual disinfection Packing Sterilization Containment and transportation ...

Page 14: ...aning and disinfection a Detergent Cidezyme Johnson Johnson 2258 or another cleaning agent with approved material compatibility for this medical device b Disinfectant Cidex OPA Johnson Johnson 20391 or another disinfectant with approved material compatibility for this medical device c Two tanks one for cleaning and one for disinfection optional 1 additional tank for rinsing with deionized tap wate...

Page 15: ...pe the immersible part of the probe under the surface of the detergent solution with a soft cloth to remove all visible soil Be sure that all grooves of the probe are implemented during the cleaning process 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 immergible parts of the probe wit...

Page 16: ...ration date of the test stripes Temperature of disinfectant solution should be minimum 20 C The minimum contact time is 5 minutes If a different disinfectant is used follow the manufacturer s instructions Please also consider the 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 tim...

Page 17: ...so 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 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...

Page 18: ...surization 162 200kPa Depressurization 13 8kPa Relative humidity 40 90 Aeration is minimum 12 hours STERRAD systems are manufactured by Johnson Johnson 1 Before performing sterilization check that the operation data of sterilizer are in conjunction with min and max data applicable for the probe 2 Do not sterilize the probe by Steam Autoclaving If you autoclave them they suffer serious damage and w...

Page 19: ...r plastic mesh wire for sterilization 4 8 Storage Store the equipment in a cool dustproof and dark space to avoid high temperature humidity and direct sunlight Limitations for the time for sterilized equipment belong to package Tray for sterilization Fig 6 Packaging in a tray Probe in the Pouch Sealed Fig 5 Sealing TYVEK Pouch ...

Page 20: ...o 4 Reprocessing Procedure 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 ...

Page 21: ... observe any of above mentioned symptoms in your patient during the operation stop the use of the latex containing medical devices immediately and take an appropriate treatment to the patient 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 con...

Page 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...

Page 23: ... Disinfectant Incidur Spray Henkel Hygiene GmbH Disinfectant STERANIOS 2 ANIOS Disinfectant ASPHENE SPRAY RIVADIS Laboratories Disinfectant Bacillol 25 BODE CHEMIE Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plus Johnson Johnson Disinfectant CIDEX OPA Johnson Johnson Disinfectant Gigasept FF Schülke Mayr Disinfectant ALKACIDE ALKAPHARM Disinfectant ALKAZYME ALKAPHARM Cleaner Please conta...

Page 24: ...es Disposal of the 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 nationa...

Page 25: ... 19 Q1E EP0995 Unit mm Fig 7 Dimensions E ...

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