Hitachi EUP-L73S Instruction Manual Download Page 32

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Q1E-EP1019

8. Specifications

8.1

Probe

Type

: EUP-L73S Linear Array Probe

Center Frequency

: 6.5MHz

Technology

: Linear Array Probe

Dimensions

: See Fig. 19.

Weight :

Approx.

0.78kg

(Including cable and connector)

Scanning width

: 38mm

Probe materials

: Biocompatible allergy free components

Acoustic output

: According to IEC60601-2-37

(See Main Unit manual.)

Applicable 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

Plasma

sterilization

Operating conditions:
Ambient temperature

: +25 - +35°C

Contact surface temperature

: max. 42°C

(Temperature of examinee)
Relative humidity

: 30 - 85%

Storage conditions:

Temperature

: -10 - +55°C

Relative humidity

: 10 - 95%

(subject to no condensation)

Summary of Contents for EUP-L73S

Page 1: ...19 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 ...

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: ...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 warning is ignored CAUTION Caution is used to indicate the presence of a hazard which will o...

Page 4: ...n 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: ... 5 4 Magnetic Sensor for EUP L73S 7 4 1 Magnetic sensor EZU RV2S 7 4 2 Magnetic sensor EZU RV3S 10 4 3 Elasto Coupler 13 5 Reprocessing Procedure 14 5 1 Point of use Pre cleaning 17 5 2 Containment and transportation 17 5 3 Manual Cleaning and disinfection 17 5 4 Drying 21 5 5 Inspection 21 5 6 Packaging 21 5 7 Sterilization 21 5 8 Storage 23 6 Maintenance and Safety Inspection 24 7 Safety Precaut...

Page 7: ...is 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 waves are r...

Page 8: ...opy Sterilization has not been made to the probe shipped from the factory Prior to use the probe be sure to clean disinfect and sterilize the probe 1 5 Option 1 Magnetic Sensor Attachment part number 7349172A 2 Spacer for EZU RV2S 3 Elasto Coupler part number 7225446A 4 Coupler Attachment EZU PA7L1 Please refer to the instruction manual of EZU PA7L1 about the method of handling cleaning and steril...

Page 9: ...lution 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 of the EUP L73S Head Immersible part IPX7 Un immersible part Cable Connector Magnetic sensor attachment Option Spacer for EZU RV2S Option Elasto coupler Option Applied part ...

Page 10: ... inspect that 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 a service support immediately 2 2 2 Visually inspect the magnetic sensor attachment and the spacer for EZU RV2S for any crack deformation or denaturalization If you find any damage do not use them and contact a service...

Page 11: ...according to the instructions given in the operation manual for the ultrasound diagnostic scanner with which the probe is used as connected 3 Confirm the direction of the probe The relationship between the direction of the probe and image is shown in Fig 2 The Right left orientation mark on the image indicates the direction of the index mark of the probe Right left orientation mark Index mark Fig ...

Page 12: ...e s position for a clear view of the desired image 6 After using the probe the magnetic sensor attachment the spacer for EZU RV2S and the elasto coupler perform the reprocessing procedure in accordance with the procedure stated in 5 Reprocessing procedure every time immediately after completing the ultrasound examination 7 Store the probe the magnetic sensor attachment the spacer for EZU RV2S and ...

Page 13: ...sor EZU RV2S The magnetic sensor EZU RV2S is shown in Fig 3 4 1 1 How to attach the Magnetic sensor The procedure of attaching the magnetic sensor is as follows 1 Attach the spacer for EZU RV2S to the magnetic sensor 2 Insert the magnetic sensor into the magnetic sensor attachment with the correct direction as shown in Fig 4 3 Place the magnetic sensor attachment on the probe as shown in Fig 5 Fit...

Page 14: ...t in false diagnosis 2 1 Magnetic sensor EZU RV2S Black Spacer for EZU RV2S Fit the insertion direction Projected part of the EZU RV2S Projected part of the Magnetic sensor attachment Spacer for EZU RV2S Magnetic sensor EZU RV2S Black Fig 4 How to attach the Magnetic sensor attachment Projected part of the Magnetic sensor attachment Index mark Fit the insertion direction Fig 5 How to attach the Ma...

Page 15: ...ase it from the probe as shown in Fig 6 2 Release the magnetic sensor from the magnetic sensor attachment as shown in Fig 7 and release the spacer from the magnetic sensor The spacer for EZU RV2S is small please do not lose the spacer Fig 7 How to release the Magnetic sensor from the Magnetic sensor attachment Fig 6 How to release the Magnetic sensor attachment from the probe CAUTION ...

Page 16: ...n Fig 9 2 Place the magnetic sensor attachment on the probe as shown in Fig 10 Fit the projected part of the magnetic sensor attachment in the index mark of the probe Direction mark of the EZU RV3S Place direction mark upward as shown here Projected part of the Magnetic sensor attachment Fit the insertion direction Fig 9 How to attach the Magnetic sensor attachment Magnetic sensor EZU RV3S White 1...

Page 17: ...or attachment to the probe in the incorrect direction otherwise it may result in false diagnosis Projected part of the Magnetic sensor attachment Index mark Fit the insertion direction Fig 10 How to attach the Magnetic sensor attachment 2 CAUTION ...

Page 18: ...lows 1 Turn around the magnetic sensor attachment and release it from the probe as shown in Fig 11 2 Release the magnetic sensor from the magnetic sensor attachment as shown in Fig 12 Fig 12 How to release the Magnetic sensor from the Magnetic sensor attachment Fig 11 How to release the Magnetic sensor attachment from the probe ...

Page 19: ...upler as shown below Attach the elasto coupler on the probe as straight as possible as shown in Fig 13 4 3 2 How to release the Elasto Coupler Release the elasto coupler from the probe as shown in Fig 14 Elasto coupler Fig 13 How to attach the Elasto coupler Elasto coupler Fig 14 How to release the Elasto coupler ...

Page 20: ... unsterile Prior to the first use reprocess the probe 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 con...

Page 21: ...his topic is listed in the table below 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 contac...

Page 22: ...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 23: ... 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 ...

Page 24: ...ergent solution according to the specified contact time of the detergent manufacturer 4 Wipe the un immergible parts of the probe with a soft cloth dipped with the detergent solution 5 Rinse the probe with running tap water for 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 15 for 5 min 6 Visually check the outer surface of t...

Page 25: ...time 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 sho...

Page 26: ...ich is 5 minutes 3 Rinse the magnetic sensor attachment and the spacer for EZU RV2S with deionized water for 1 minute alternatively immerse them in a tray filled with deionized water see Fig 15 for 5 min 4 Visually check the outer surface of the magnetic sensor attachment and the spacer for EZU RV2S for leavings of the disinfectant If necessary repeat the rinsing Water Detergent Disinfectant Fig 1...

Page 27: ...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 by...

Page 28: ...Pa 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 and the attachment 2 Do not sterilize the probe and the attachment by Steam Autoclaving If you autoclave them they suffer s...

Page 29: ... plastic mesh wire for sterilization 5 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 Sealed Fig 17 Sealing TYVEK Pouch Tray for sterilization Fig 18 Packaging in a tray Probe in the Pouch ...

Page 30: ...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 3 Visually inspect the surface of the magnetic sensor attachment and the spacer for EZU RV2S for any crack deformation or denaturalization If you find any damage do not use them and contact a service support immediately 4 Visually i...

Page 31: ...he connector to water or other liquids The connector is not waterproof Do not hit or drop the probe The probe is easily damaged by mechanical shock Do not use detergents and disinfectants other than listed in 8 2 Suppliers list Use a sterile probe cover to avoid staining or damaging the acoustic lens Clean disinfect and sterilize the probe the magnetic sensor attachment and the elasto coupler befo...

Page 32: ...ystem 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 tempe...

Page 33: ...Disinfectant ANIOXYDE1000 ANIOS Disinfectant Virkon S ANTEC Disinfectant ASPHENE SPRAY RIVADIS Disinfectant Laboratories Bacillol 25 BODE CHEMIE Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plus Johnson Johnson Disinfectant CIDEX OPA Johnson Johnson Disinfectant Gigasept FF Schülke Mayr Disinfectant Tristel 1 Day Tristel Company Disinfectant Tristel Multi Shot Tristel Company Disinfectant...

Page 34: ...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 35: ... 29 Q1E EP1019 Unit mm Fig 19 Dimensions ...

Page 36: ... 30 Q1E EP1019 Fig 20 External view with the Magnetic sensor attachment ...

Page 37: ... 31 Q1E EP1019 Fig 21 External view with the Elasto coupler E ...

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