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Q1E-EP1432

1.3

Intended Use

C41V1 Probe is designed for observation and diagnosis of the
following regions mainly by connecting with the HITACHI ultrasound
diagnostic scanner.



General OB/GYN organs



Biopsy (with a Sterile Puncture Adapter)



Transvaginal/Transrectal

Never use the probe for following regions.

1)

The heart (Do not contact directly)

2)

The eyeball

1.4

Components

Components of C41V1 Probe are as follows:
1)

Probe ............................... 1 piece

2)

Instruction Manual .................. 1 copy

The probe is not sterilized when delivered. Prior to use, be sure
to clean, disinfect and sterilize it.

WARNING

CAUTION

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Содержание C41V1

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: ... support The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning indicates the presence of a hazard which may result in severe personal injury substantial property damage or death if the warning is ignored CAUTION Caution indicates the presence of a hazard which will or can cause minor personal injury or property damage if the caution is i...

Страница 4: ...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 keep away from high temperature high humidity or direct sunlight Contains or ...

Страница 5: ...ED 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 Do not waste the instrument as general waste Comply with...

Страница 6: ...re Adapter EZU PA7V 8 3 3 Display of Needle Guide Line 9 4 Option of C41V1 Probe 11 4 1 Magnetic sensor 11 5 Cleaning Disinfection and Sterilization 13 5 1 Point of use Pre cleaning 16 5 2 Containment and transportation 17 5 3 Manual Cleaning and disinfection 17 5 4 Drying 21 5 5 Inspection 21 5 6 Packaging 22 5 7 Sterilization 23 5 8 Storage 25 6 Maintenance and Safety Inspection 26 6 1 Daily Ins...

Страница 7: ...nic 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 boun...

Страница 8: ... OB GYN organs Biopsy with a Sterile Puncture Adapter Transvaginal Transrectal Never use the probe for following regions 1 The heart Do not contact directly 2 The eyeball 1 4 Components Components of C41V1 Probe are as follows 1 Probe 1 piece 2 Instruction Manual 1 copy The probe is not sterilized when delivered Prior to use be sure to clean disinfect and sterilize it WARNING CAUTION ...

Страница 9: ...physician only should perform a biopsy 1 5 2 Probe cover for Single Use Disposable To protect the probe against contamination using probe cover is recommended If using probe cover lubrication free or dry type probe cover is recommended Lubrication may cause a deterioration of the probe surface Use of non allergic probe cover is strongly recommended to avoid allergic reactions due to latex rubber D...

Страница 10: ...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 Cable Connector Un immersible part Immersible part IPX7 Applied part Magnetic sensor attachment Option ...

Страница 11: ... the probe according to 3 Operation Procedure Display the Needle guide line on the monitor Refer to the operation manual of the ultrasound diagnostic scanner Keep the probe head under sterile water and insert a puncture needle in the Sterile Puncture Adapter then confirm that the needle is inserted smoothly and the echo of the needle is displayed on the Needle guide line dot line on the monitor 2 ...

Страница 12: ...d be allergy free material to avoid allergic reaction 3 Connect the probe to the ultrasound diagnostic scanner and operate the scanner and adjust the image according to the instructions given in the operation manual for the ultrasound diagnostic scanner The relationship between the direction of the probe and the right left orientation mark on the image is shown in Fig 2 4 Put proper quantity of st...

Страница 13: ...ock If you observe any of above mentioned symptoms in your patient during the operation stop the use of the latex protective sleeve immediately and take an appropriate treatment to the patient 6 Fix the probe cover with sterile adhesive tape as shown in Fig 5 Visually inspect the probe cover for any hole or tears 7 Insert the probe gentry and adjust the probe s position for a clear view of the des...

Страница 14: ... and at the lowest possible output There is the possibility that the patient s tissues could be affected For details about the acoustic output please refer to the operation manual of the ultrasound diagnostic instrument 3 2 How to attach the Sterile Puncture Adapter EZU PA7V How to attach the Sterile Puncture Adapter EZU PA7V to the probe is instructed below 1 Put the picks of the Sterile Puncture...

Страница 15: ...nd image when performing the puncture operation The needle guide line can be displayed for this probe but if the image is displayed at some angle see the figures below the image displayed may not be appropriate for biopsy Confirm that the image displayed is appropriate prior to biopsy Probe Puncture adapter Needle guide line Artifact of puncture adapter Artifact of puncture adapter may appear whil...

Страница 16: ...e patient 2 The puncture adapter EZU PA7V and the recommended probe covers are disposable and must not be reused 3 Sterilize disinfect the probe and disinfect the puncture adapter when the probe cover is torn 4 Be careful about the use of a needle cannula with the puncture adapter If the insulation coating of the needle cannula is damaged it may cause a burn to tissue 5 Use a needle whose size is ...

Страница 17: ...Magnetic sensor into the Magnetic sensor attachment in the correct direction as shown in Fig 7 Never attach the Magnetic sensor attachment to the probe in the Wrong direction otherwise it may result in false diagnosis 3 Attach the Magnetic sensor attachment to the probe as shown in Fig 8 Fig 7 How to attach the Magnetic sensor Direction mark Magnetic sensor attachment Magnetic sensor CAUTION Fig 8...

Страница 18: ...etic sensor is as follow 1 Detach the Magnetic sensor attachment from the probe as shown in Fig 9 2 Detach the magnetic sensor from the Magnetic sensor attachment as shown in Fig 10 Clean disinfect and sterilize the Magnetic sensor attachment prior to the first use as it is not sterilized when delivered Fig 9 How to release the Magnetic sensor attachment from the probe Fig 10 How to release magnet...

Страница 19: ...eed 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 Sterile Supply Department CSSD to an operating ...

Страница 20: ...ow 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 op...

Страница 21: ...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 22: ...ter until the surface of the probe looks visually clean 3 Wipe the whole surface of the probe with gauze pad and remove superficial visible impurities B Magnetic sensor attachment 1 Remove the Magnetic sensor attachment and the magnetic sensor from the probe 2 Immerse the Magnetic sensor attachment in sufficient amount of high quality tap water Scrub it using soft cloth to remove all visible soil ...

Страница 23: ...t 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 water sufficient size for immersion of the immersible part of the probe at full length d Soft fluff free cloth or single use towel e Personal protective equipment gloves...

Страница 24: ...ure 11 Wipe 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 immersible parts of the ...

Страница 25: ...ution Wipe it under the surface of the detergent solution with a soft cloth to remove all visible soil 3 The Magnetic sensor attachment should be left in the detergent solution according to the specified contact time of the detergent manufacturer 4 Rinse the Magnetic sensor attachment with running tap water for 1 minute alternatively immerse it in a tray filled with deionized water tap water see F...

Страница 26: ...low 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 11 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 ...

Страница 27: ...e surface of the equipment 2 Dry the equipment naturally in an ambient temperature between 15 30 C for a minimum of 4 hours Alternatively the equipment can be dried using a drying heater at a temperature of less than 60 C 5 5 Inspection Inspect the equipment for any damage such as crack scratch or deformation Do not use it if any damage is found Fig 11 Immersion of the Probe and the Magnetic senso...

Страница 28: ...stic 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 appropriate sealing machine and it is important to confirm that th...

Страница 29: ...n STERRAD 50 100S or 200 Short Cycle Plasma Sterilization Sterrad 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 opera...

Страница 30: ...ckaging procedure is as follows 1 Put the probe into TYVEK pouch 2 Seal the TYVEK Pouch using a heat sealer Ensure that the seal is complete TYVEK Pouch Probe TYVEK Pouch Sealed Fig 12 Packaging in the pouch Fig 13 Sealing ...

Страница 31: ...sterilization 5 8 Storage Store the equipment in a cool dustproof and dark dry space to avoid high temperature humidity and direct sunlight Limitations for the time for sterilized equipment belong to package Probe in the Pouch Tray for sterilization Fig 14 Packaging in a tray ...

Страница 32: ...mmediately 6 1 2 Visually inspect the surface of the Magnetic sensor attachment for any crack deformation or denaturalization If you find any damage do not use it and contact a service support immediately 6 2 Storage After using the probe and accessory they should be cleaned and disinfected sterilized according to 5 Cleaning disinfection and Sterilization immediately Then store them in a cool and ...

Страница 33: ...nducting examinations with the bare hands can expose the operator to a risk of infection 8 Do not use the probe fallen on to floor Otherwise there is a risk of infection Stop the operation and perform the inspection cleaning and disinfection or sterilization according to section 2 Inspection before Use and section 5 Cleaning Disinfection and Sterilization 9 When using ultrasound contrast agent fol...

Страница 34: ... lens against staining or damaging 7 Clean disinfect and sterilize the probe and the Magnetic sensor attachment prior to the first use as they are not sterilized when delivered 8 Use only the soft cloth or tissue to clean the acoustic lens 9 Only a well trained physician should perform a biopsy 10 Do not use this probe with other equipment except for those specifically approved in the manual Use w...

Страница 35: ...ing 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 10 40 C Contact surface temperature Tempe...

Страница 36: ...ble needle gauge 16G to 19G Materials Bio compatible allergy free components Classification MDD classification IIa Package 24 Sterile Puncture Adapters for single use Sterilization method Sterilized with gamma irradiation Operating conditions Temperature 10 40 C Storage conditions Temperature 10 40 C ...

Страница 37: ...istributor for a current version of the Disinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 9 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 pr...

Страница 38: ... 32 Q1E EP1432 unit mm Fig 15 External view of C41V1 Probe ...

Страница 39: ... 33 Q1E EP1432 E Fig 16 External view of C41V1 Probe with Sterile Puncture Adapter EZU PA7V ...

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