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Q1E-EP0348

Definition of symbol

The following symbol is also used for HITACHI Ultrasound Probes.

Location Symbol

Definition

Probe connector

This instrument complies with
Directive 93/42/EEC relating to

Medical Device and Directive
2011/65/EU relating to RoHS

Probe connector

IPX7

IPX7 mark
See section

1.6.

Probe connector

Type BF APPLIED PART

Probe connector

General warning sign

Probe connector

Warning; dangerous voltage

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 degrees”.

Probe connector

Do not waste the instrument as

general waste. Comply with a
local regulation.

Probe connector

Rx Only

By prescription only. U.S.

Federal Law restricts this
device to sale on order of a
physician only.

Содержание EUP-L52

Страница 1: ...pan Q1E EP0348 14 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: ...tions 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 are ignored CAUTION Caution is used to indicate the presence of a hazard which will or ...

Страница 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 ...

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: ...ection for Material Surface 7 3 Operation Procedure 8 4 Reprocessing Procedure 10 4 1 Point of use Pre cleaning 13 4 2 Containment and transportation 13 4 3 Manual Cleaning and disinfection 13 4 4 Drying 16 4 5 Inspection 16 4 6 Packaging 16 4 7 Sterilization 16 4 8 Storage 18 5 Maintenance and Safety Inspection 18 5 1 Daily check 18 6 Safety Precautions 19 7 Specifications 20 7 1 Probe 20 7 2 Sup...

Страница 7: ...age diagnosis using ultrasonic 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 ...

Страница 8: ...e probe for following applications Direct contact to the heart Biopsy to the heart Direct contact to the eye 1 4 Composition Probe 1 piece Instruction Manual 1 copy 1 5 Accessories OPTION 1 5 1 Coupler attachment EZU PA3C1 Option Applicable model EUP L53S and L52 By attaching the coupler attachment EZU PA3C1 the blood flow in the shallow blood vessel can be detected by keeping a suitable angle The...

Страница 9: ...nual 1 copy A 20 22 gauge biopsy needle is available inside the needle guide 1 5 3 Coupler attachment EZU PA3C2 Option Applicable model EUP L53S and L52 By attaching the coupler attachment EZU PA3C2 a better image for shallow parts by shifting of a focal zone to the parts is achieved The optional coupler attachment EZU PA3C2 components are as follows Component Model Note 1 Coupler attachment EZU P...

Страница 10: ...s 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 Please refer to the instruction manual of EZU WL2 about the method of handling cleaning and disinfecting it 1 5 5 Water bag EZU WL3 Option Applicable model EUP L53L By attaching a water bag EZU W...

Страница 11: ...bout the method of handling cleaning and disinfecting it 1 5 6 Biopsy Attachment EZU PA3L Option Applicable model EUP L53 The biopsy attachment EZU PA3L is a dedicated tool for use as mounted on a EUP L53 The optional biopsy attachment EZU PA3L components are as follows Component Note 1 Biopsy guide assembly 1 piece 2 Needle guide 14G 18G 21G 1 each 3 Brush 1 piece 4 Instruction manual 1 copy 5 Bi...

Страница 12: ...o can not be cleaned by water Cable Connector Immersible part IPX7 Applied part Head Fig 2 External view EUP L53 L53L Un immersible part Immersible part This part can be immersed in disinfectant sterilant solution and can be cleaned by water Un immersible part This part should not be immersed in disinfectant sterilant solution and also can not be cleaned by water Cable Connector Immersible part IP...

Страница 13: ...ion of 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 nor instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection of material surface 2 2 1 Visually check the surface of the probe head housing and cable for any crack scratch or denaturalization ...

Страница 14: ...he image indicates the direction of the index mark on the probe 3 When using under sterile condition protect the probe by using covers Some Latex material creates allergic reaction Please use allergy free material covers 4 Caution in case of wiping off the ultrasound jelly or cleaning the surface of the acoustic lens Fig 3 Relationship between Index Mark and Right left Orientation Mark EUP L53S L5...

Страница 15: ...ution Therefore in case of wiping off the ultrasound jelly or cleaning the surface of the acoustic lens please use a soft cloth or tissue paper and handle with care See Fig 4 Soft cloth or tissue paper Acoustic lens Fig 4 Wiping off the ultrasound jelly or cleaning the surface of the acoustic lens CAUTION ...

Страница 16: ...rocess the probes Temperature should not exceed 60 C during 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 Ste...

Страница 17: ...r 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 operative ap...

Страница 18: ...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 ...

Страница 19: ... before manual cleaning 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 ...

Страница 20: ...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...

Страница 21: ...pes 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 5 Set a clock to insure the recommended contact time which is 5 minutes 4 Rinse...

Страница 22: ...lso 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 seale...

Страница 23: ...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 suffers serious damage and ...

Страница 24: ...temperature humidity and direct sunlight Limitations for the time for sterilized equipment belong to package 5 Maintenance and Safety Inspection 5 1 Daily check Visually check the surface of the probe head housing and cable for any crack scratch or denaturalization If you find damage do not use the probe and immediately contact a service support Sealed Fig 7 Sealing TYVEK Pouch Tray for sterilizat...

Страница 25: ...y 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 uses store the probe holder of scanner Under sterile condition use...

Страница 26: ...put According to IEC60601 2 37 See Main Unit manual Applicable systems Depending on production and upgrade status For detailed information contact a service support Classification MDD classification IIa Cleaning Applicable disinfectants are listed in the suppliers list Sterilization ETO gas sterilization Plasma sterilization Operating conditions Ambient temperature 25 35 C Contact surface temperat...

Страница 27: ...Disinfectant Incidur Spray Henkel Hygiene GmbH Disinfectant STERANIOS 2 ANIOS Disinfectant Cidex plus Johnson Johnson Disinfectant Cidex OPATM Johnson Johnson Disinfectant Gigasept FF Schülke Mayr Disinfectant ALKACIDE ALKAPHARM Disinfectant ASPHENE SPRAY RIVADIS Disinfectant Bacillol 25 BODE CHEMIE Disinfectant ANIOXYDE1000 ANIOS Disinfectant Virkon S ANTEC Disinfectant ALKAZYME ALKAPHARM Cleaner...

Страница 28: ...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...

Страница 29: ... 23 Q1E EP0348 2200 108 5 27 87 60 150 65 Unit mm Fig 9 Dimension Diagram of Probe EUP L53 ...

Страница 30: ... 24 Q1E EP0348 60 150 65 2200 109 108 23 Fig 10 Dimension Diagram of Probe EUP L53L Unit mm ...

Страница 31: ... 25 Q1E EP0348 65 26 46 102 2200 60 150 Unit mm Fig 11 Dimension Diagram of Probes EUP L53S and EUP L52 E ...

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