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Q1E-EP0403

CONTENTS

Page

Introduction ················································· 1

1.1

Features ················································· 1

1.2

Principles of operation ·································· 1

1.3

Intended Use ············································· 2

1.4

Composition ·············································· 2

1.5

Accessories (Option) ····································· 2

1.6

Construction ············································· 3

Inspection before Use ········································ 4

2.1

Inspection for Appropriate Connection ···················· 4

2.2

Inspection for Material Surface ·························· 4

Operation Procedure ·········································· 5

Cleaning, Disinfection and Sterilization ····················· 6

4.1

Point of use (Pre-cleaning) ······························ 7

4.2

Containment and transportation ··························· 7

4.3

Manual Cleaning and disinfection ························· 8

4.4

Drying ··················································· 9

4.5

Inspection ·············································· 10

4.6

Packaging ··············································· 10

4.7

Sterilization ··········································· 11

4.8

Storage ················································· 13

Maintenance and Safety Inspection ··························· 13

Safety Precautions ·········································· 14

Specifications ·············································· 15

7.1

Probe ··················································· 15

7.2

Suppliers List ·········································· 16

Disposal of the probe ······································· 16

Содержание EUP-O53T

Страница 1: ...403 9 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: ...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...

Страница 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...

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: ...2 2 Inspection for Material Surface 4 3 Operation Procedure 5 4 Cleaning Disinfection and Sterilization 6 4 1 Point of use Pre cleaning 7 4 2 Containment and transportation 7 4 3 Manual Cleaning and disinfection 8 4 4 Drying 9 4 5 Inspection 10 4 6 Packaging 10 4 7 Sterilization 11 4 8 Storage 13 5 Maintenance and Safety Inspection 13 6 Safety Precautions 14 7 Specifications 15 7 1 Probe 15 7 2 Su...

Страница 7: ...trasonic 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: ... and sterilized prior to its first use 1 5 Accessories Option 1 5 1 Biopsy Attachment EZU PA5O Option The biopsy attachment EZU PA5O is a dedicated tool for use as mounted on a EUP O53T The optional biopsy attachment EZU PA5O components are as follows 1 Biopsy attachment 1 piece Each of 14G 18G and 21G exist During ordering our biopsy attachment please specify the kind of puncture needle gauge use...

Страница 9: ...r Cable 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 water Fig 1 External View Un immersible part Applied part ...

Страница 10: ...horized devices nor instruments on the probe such as unauthorized biopsy attachments If a biopsy operation is required refer to its instruction manual for inspection preparation operation and cleaning through sterilization 2 1 2 Check that the system is correctly operating Refer to the instruction manual for the main unit 2 2 Inspection for Material Surface 2 2 1 Visually check the surface of the ...

Страница 11: ...y method is required refer to its instruction manual 5 After the use of the probe it should be cleaned and disinfected and sterilized then store it in an adequate place 1 Since the acoustic jelly accessory to the ultrasound scanner is not a sterilized one never use it 2 We recommend you to use a sterilized probe cover in order to minimize sticking of body fluid to the probe Apply sterilized jelly ...

Страница 12: ...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...

Страница 13: ...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...

Страница 14: ...lease 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 instruction If a differing detergent is used please also note the approved material compatibility for the medical device 2 Im...

Страница 15: ...e expiration 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 conta...

Страница 16: ...sterile barrier Additionally the equipment can be placed on plastic mesh wires supplied for plasma sterilization and then packed as mentioned above The equipment 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 app...

Страница 17: ...terrad NX or 100NX Standard cycle ETO Sterilization Gas Type 10 EO 90 HCFC Temperature 50 55 C Exposure Time More than 120 minutes Pressurization 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...

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 4 Packaging in the pouch Probe TYVEK Pouch Sealed Probe Fig 5 Sealing Fig 6 Packaging in a tray Tray for sterilization Probe in the Pouch ...

Страница 19: ...n 1 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 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 pro...

Страница 20: ...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 cont...

Страница 21: ...epending 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 temperature ...

Страница 22: ...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 the equipment disinfect or take other infection prevention measures Disposal of the equipment without taking the proper preventative measures can lead to infection Waste Electrical and Electronic Equipment WEEE Directive The illustrati...

Страница 23: ... 17 Q1E EP0403 Unit mm Fig 4 Dimensions E ...

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