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VC34A Probe

INSTRUCTION MANUAL

Tokyo, Japan

Q1E-EP1398-4

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.

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Содержание VC34A Probe

Страница 1: ...achi 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: ...tructions by thoroughly reading and understanding this manual Please contact a service support if you have any questions concerning the operation of the probe 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 th...

Страница 4: ... 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 dark and dr...

Страница 5: ...robe 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 Do not waste the instrument as general waste Comply with a local regulation Probe con...

Страница 6: ...onnection 4 2 2 Inspection for Material Surface 4 3 Operation Procedure 5 4 Reprocessing Procedure 6 4 1 Point of use Pre cleaning 9 4 2 Containment and transportation 9 4 3 Manual Cleaning and disinfection 9 4 4 Drying 12 4 5 Inspection 12 4 6 Storage 12 5 Maintenance and Safety Inspection 13 6 Safety Precautions 14 7 Specifications 15 7 1 Probe 15 7 2 Suppliers List 16 8 Disposal of the probe 17...

Страница 7: ...enable image 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 ul...

Страница 8: ...ing applications Direct contact to the heart Biopsy to the heart Direct contact to the eye 1 4 Components The components of VC34A Probe are given below 1 Probe 1 piece 2 Instruction manual 1 copy 3 Correct Backlash CD ROM 1 piece The CD ROM contains the probe s specific parameters to be loaded to the Hitachi ultrasound diagnostic scanner Hitachi service engineer installs the CD ROM to the scanner ...

Страница 9: ...rnal view of VC34A Probe is shown in Fig 1 Immersible part IPX7 Scan head Connector Cable 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 water Fig 1 External view Handle housing Applied part CAUTION ...

Страница 10: ... Confirm that the system is correctly operating Refer to the instruction manual for the ultrasound diagnostic scanner 2 2 Inspection of material surface 2 2 1 Visually inspect the surface of the probe head housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use the probe and immediately contact a service support ...

Страница 11: ... in the operation manual for the ultrasound diagnostic scanner with which the probe is used as connected 4 Confirm the direction of the probe The relationship between the direction of the probe and the B mode image is shown in Fig The right left orientation mark on the image indicates the direction of the index mark on the probe 5 Perform the reprocessing procedure in accordance with the procedure...

Страница 12: ...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 ...

Страница 13: ...low 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 o...

Страница 14: ...ocessing process 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 Containment and transportation ...

Страница 15: ...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...

Страница 16: ...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 17: ...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...

Страница 18: ...tion Do not use it if any damage is found 4 6 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 1 Do not sterilize this probe by pressurizing depressurizing sterilization system such as ETO and Plasma system If you sterilize the probe by these systems the membrane...

Страница 19: ...e the probe and immediately contact a service support 2 Inspect the functionality of Real time 3D mode If you find abnormalities such as abnormal noise do not use the probe and contact immediately a service support 3 After using the probe the probe should be cleaned and disinfected according to 4 Reprocessing Procedure store the probe in a cool and dark space to avoid high temperature humidity and...

Страница 20: ...tients 1 Start examination with acoustic power low and set the acoustic power as low as possible for ultrasound examination of an early pregnancy And minimize the ultrasound exposure time 2 Disinfect the probe prior to the initial use since the probe is not delivered disinfected 3 Use only detergents and disinfectants listed in 7 2 Suppliers list 4 Use sterile acoustic coupling gel depending on th...

Страница 21: ...mpliance with IEC60601 2 37 Applicable ultrasound Contact a service support for detail diagnostic scanner Classification MDD classification IIa Applicable detergent Detergents listed in 7 2 Suppliers list Allicable Disinfectant Disinfectant listed in 7 2 Suppliers list Operating conditions Ambient temperature 10 35 C Contact surface temperature temperature of examinee max 42 C Relative humidity 30...

Страница 22: ...Steranios 2 Laboratoires ANIOS High level Disinfectant CIDEX Johnson Johnson High level Disinfectant CIDEX OPA Johnson Johnson High level Disinfectant CIDEXPLUS 28 Johnson Johnson High level Disinfectant Please contact your local distributor for a current version of the Disinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List Disinfection with CIDEX OPA may cause dis...

Страница 23: ...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 24: ... 18 Q1E EP1398 Fig 4 Dimensions Unit mm E ...

Страница 25: ......

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