Hitachi EUP-C514 Instruction Manual Download Page 1 | Manualshive

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background image

Convex

Array

Probe

EUP

‐

C514

INSTRUCTION

MANUAL

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.

Tokyo,

Japan

Q1E

‐

EP0428

‐

10

©

Hitachi,

Ltd.

2013,2017.

All

rights

reserved.

0123

1
2
3
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Summary of Contents for EUP-C514

Page 1: ...nd 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 Tokyo Japan Q1E EP0428 10 Hitachi Ltd 2013 2017 All rights reserved 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: ...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...

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: ...ace 5 3 Operation Procedure 6 4 Option of Hitachi ultrasound diagnostic sensor 7 4 1 Magnetic Sensor EZU RV2S 7 4 2 Magnetic Sensor EZU RV3S 10 5 Reprocessing Procedure 13 5 1 Point of use Pre cleaning 15 5 2 Containment and transportation 15 5 3 Manual Cleaning and disinfection 15 5 4 Drying 18 5 5 Inspection 18 5 6 Packaging 18 5 7 Sterilization 18 5 8 Storage 20 6 Maintenance and Safety Inspect...

Page 7: ...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 refl...

Page 8: ...al organs General OB GYN organs Biopsy with Biopsy Attachment Never use the probe for following applications Direct contact to the heart Biopsy to the heart 1 4 Composition The components of the EUP C514 are given follows 1 Probe EUP C514 1 piece 2 Instruction 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 and steriliz...

Page 9: ...e Guide Bracket EZU PA5C1 1 Needle guide bracket 1 piece 2 Brush 1 piece 3 Spring Spare 2 pieces 4 Instruction manual 1 copy 5 Biopsy case 1 piece Please refer to the instruction manual of option about the method of handling cleaning and sterilizing the needle guide bracket EZU PA5C1 1 6 Option of Hitachi ultrasound diagnostic scanner 1 6 1 Magnetic Sensor Attachment 1 Magnetic sensor attachment 2...

Page 10: ...itachi ultrasound diagnostic scanner Magnetic sensor attachment Option of Hitachi ultrasound diagnostic scanner Fig 1 External View 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 cannot be cleaned by water ...

Page 11: ...tic scanner 2 Do not attach or connect unauthorized devices or 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 2 Inspection for Material Surface 1 Visually inspect the surface of the probe and head housing the cable and the connector for any c...

Page 12: ... instruction manual 6 Under sterile condition protecting the probe by using covers is recommended Some Latex material may create allergic reaction Please use allergy free material covers 7 After using the probe perform the reprocessing procedure in accordance with the procedure stated in 5 Reprocessing procedure of the probe every time immediately after completing the ultrasound examination 8 Afte...

Page 13: ... Magnetic Sensor EZU RV2S The Magnetic sensor EZU RV2S as shown in Fig 3 is a magnetic sensor for the EUP C514 4 1 1 How to attach the Magnetic Sensor The Procedure of attaching the Magnetic sensor is as follows 1 Confirm that the probe the Magnetic sensor attachment and the Spacer for EZU RV2S are disinfected or sterilized 2 Connect the probe operate the ultrasound diagnostic scanner and adjust t...

Page 14: ... the probe in the incorrect direction otherwise it may result false diagnosis Never forget to attach the Spacer for EZU RV2S to the Magnetic sensor otherwise it may result in false diagnosis Fig 4 How to attach the Magnetic sensor Hole of the Magnetic sensor attachment Spacer for EZU RV2S Projected part of the Magnetic sensor Fit the insertion direction Magnetic sensor EZU RV2S Black Index mark Fi...

Page 15: ...ensor attachment and release 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 for EZU RV2S from the Magnetic sensor The Spacer for EZU RV2S is small so please do not lose the spacer Fig 6 How to release the Magnetic sensor attachment Fig 7 How to release the Magnetic sensor ...

Page 16: ...ltrasound diagnostic scanner and adjust the image according to the instructions given in the operation manual for the ultrasound diagnostic scanner 3 To use Real time Virtual Sonography RVS attach the magnetic sensor as shown below a Attach the Magnetic sensor into the probe with the correct direction as shown in Fig 9 Fig 8 Magnetic sensor EZU RV3S Magnetic sensor white Direction mark Fig 9 How t...

Page 17: ...f the Magnetic sensor attachment in the index mark of the probe Never attach the Magnetic sensor attachment to the probe in the incorrect direction otherwise it may result in false diagnosis Index mark Fit the insertion direction Fig 10 How to attach the Magnetic sensor attachment Hole of the Magnetic sensor attachment ...

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

Page 19: ...terile pouch or container during 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 b...

Page 20: ...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 21: ... as possible and not later than 4 hours after usage 5 3 Manual Cleaning and disinfection a Prepare following items before manual cleaning and disinfection b Detergent Cidezyme Johnson Johnson 2258 or another cleaning agent with approved material compatibility for this medical device c Disinfectant Cidex OPA Johnson Johnson 20391 or another disinfectant with approved material compatibility for this...

Page 22: ...ute alternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 13 for 5 min 6 Visually check the outer surface of the probe for cleanness If necessary use magnifying glass for visually check If there is still soil visible repeat all above steps B Magnetic Sensor Attachment 1 The temperature of the detergent solution should be between 15 30 C conc...

Page 23: ...mpatibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 13 Set a clock to insure the recommended contact time which is 5 minutes 4 Rinse the immersible part of the probe with deionized water for 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water see Fig 18 for 5 min 5 Visually check the outer sur...

Page 24: ...vered 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 a...

Page 25: ...surization 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 suffers serious d...

Page 26: ...r 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 Probe Attachment Fig 15 Sealing TYVEK Pouch Tray for sterilization Fig 16 Packaging in a tray ...

Page 27: ...nd contact a service support immediately 3 After using the Magnetic sensor attachment and the Spacer for EZU RV2S the Magnetic sensor attachment and the Spacer for EZU RV2S should be cleaned and disinfected or sterilized according to 6 Reprocessing Procedure of the Magnetic Sensor Attachment store the Magnetic sensor attachment and the Spacer for EZU RV2S in a cool and dark space to avoid high tem...

Page 28: ...and take an appropriate treatment to the patient Keep the acoustic power low and minimize the ultrasound exposure time for the examination of an early pregnancy Do not expose the 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 9 2 Suppliers l...

Page 29: ...ding 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 or Plasma sterilization Operating conditions Ambient temperature 25 to 35 C Contact surface temperatur...

Page 30: ...t Incidin Liquid Henkel Hygiene GmbH Disinfectant Incidur Spray Henkel Hygiene GmbH Disinfectant Meliseptol HBV Tücher Braun Disinfectant STERANIOS 2 ANIOS Disinfectant Sterile protection Product International Medical Covers Transducer covers CIVCO Medical Covers Tristel 1 Day Tristel Company Disinfectant Tristel Multi Shot Tristel Company Disinfectant Virkon S ANTEC Disinfectant Please contact yo...

Page 31: ... 25 E Q1E EP0428 Fig 17 Dimensions Unit mm ...

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