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Intraoperative Probe

EUP-O732T

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-EP1234-7

Содержание EUP-O732T

Страница 1: ...ators 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 EP1234 7 Hitachi Ltd 2013 2017 All rights reserved ...

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 Address Hitachi Medical Systems Europe Holding AG 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 ig...

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: ...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: ... 7 4 2 Magnetic Sensor EZU RV3S 9 5 Cleaning and Disinfection and Sterilization 12 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 Inspection 21 6 1 Daily Inspection 21 6 2 Store 21 7 Safety Precautions 22 8 Specifications 24 8...

Страница 7: ...tion This probe and the ultrasound diagnostic scanner 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 o...

Страница 8: ...he probe shipped from the factory Prior to use of the probe be sure to clean disinfect and sterilize them following this instruction manual 1 5 Accessories Option 1 Magnetic Sensor Attachment Magnetic sensor attachment is used for Real time Virtual Sonography RVS It is used to fix the magnetic sensor to the probe 2 Spacer for EZU RV2S Spacer for EZU RV2S is the spacer needed to fix the magnetic se...

Страница 9: ...ctant 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 Immersible part IPX7 Cable Connector Un immersible part Fig 1 External View Scan head Probe housing Applied part Spacer for EZU RV2S Option Magnetic sensor attachment Option ...

Страница 10: ...o the instruction manual of the Main unit for the operation 2 Confirm that any unauthorized devices or instruments such as an unauthorized biopsy attachment is not attached or connected to the probe 2 2 Inspection for Material Surface 1 Visually inspect the surface of the probe head housing and cable for any crack scratch or denaturalization 2 Visually inspect the Magnetic sensor attachment and th...

Страница 11: ...ergy free material to avoid allergic reaction 3 Connect the probe to the ultrasound diagnostic scanner and operate the scanner Then adjust the image according to the instructions given in the operation manual for the scanner 4 The relationship between the direction of the probe and the right left orientation mark on image is shown in Fig 2 5 Use under sterile condition protecting the probe by usin...

Страница 12: ... probe if the image and the frequency do not match the probe An incorrect acoustic output can result in burns or other injuries to the patient Scan for the minimum length of time necessary for the diagnosis 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 ultraso...

Страница 13: ...sor is as follow 1 Confirm that the magnetic sensor attachment and the Spacer for EZU RV2S are disinfected and sterilized 2 Connect the probe to the ultrasound diagnostic scanner and operate the scanner Then adjust the image according to the instructions given in the operation manual for the scanner 3 To use RVS Real time Virtual Sonography attach the magnetic sensor as shown below in the out of o...

Страница 14: ...ttachment to the probe as shown in Fig 5 Do not put your fingers between the Magnetic Sensor Attachment and the Probe when attaching the Magnetic sensor attachment to the probe 4 1 2 How to Release the Magnetic Sensor The procedure of releasing the Magnetic sensor is as follow 1 Detach the Magnetic sensor attachment from the probe as shown Fig 6 in the out of operative field Fig 5 How to attach th...

Страница 15: ...w to Attach the Magnetic Sensor EZU RV3S The procedure of attaching Magnetic sensor is as follow 1 Confirm that the Magnetic sensor attachment is disinfected and sterilized 2 Connect the probe to the ultrasound diagnostic scanner and operate the scanner Then adjust the image according to the instructions given in the operation manual for the scanner 3 To use RVS Real time Virtual Sonography attach...

Страница 16: ... diagnosis b Attach the Magnetic sensor attachment to the probe as shown in Fig 10 Do not put your fingers between the Magnetic sensor attachment and the probe when attaching the Magnetic sensor attachment to the probe Direction mark of EZU RV3S Magnetic sensor EZU RV3S White Direction mark of EZU RV3S Magnetic sensor attachment Fig 9 How to attach the Magnetic sensor Fig 10 How to attach the Magn...

Страница 17: ...of operative field 2 Detach the magnetic sensor from the Magnetic sensor attachment as shown Fig 12 in the out of operative field Clean disinfect and sterilize the Magnetic sensor attachment before the first use as it is not sterilized in the factory Fig 11 How to release the Magnetic sensor attachment from the probe Fig 12 How to release magnetic sensor from the Magnetic sensor attachment CAUTION...

Страница 18: ...xceed 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 operatin...

Страница 19: ...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 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 ...

Страница 21: ...sible and not later than 4 hours after usage 5 3 Manual Cleaning and disinfection Prepare following items 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 ...

Страница 22: ... 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 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 Attac...

Страница 23: ... 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 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 minut...

Страница 24: ...ek and then place it into a tray The tray should be also 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...

Страница 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...

Страница 26: ... 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 Probe in the Pouch Fig 16 Packaging in a tray ...

Страница 27: ... the Magnetic sensor attachment and the Spacer for EZU RV2S for any crack deformation or denaturalization If you find any damage do not use the Magnetic sensor attachment and contact a service support immediately 6 2 Storage After the using the probe the Magnetic sensor attachment and the Spacer for EZU RV2S They should be cleaned and disinfected and sterilized following 5 Cleaning and disinfectio...

Страница 28: ...isassemble modify or repair the probe Electric shock or other unforeseen accidents could result Wear medical gloves during examination Conducting examinations with the bare hands can expose the operator to a risk of infection 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 and sterilization accor...

Страница 29: ...e acoustic lens Clean disinfect and sterilize the probe Magnetic sensor attachment and Spacer for EZU RV2S before the first use as they are not sterilized in the factory Use only the soft cloth or tissue to clean the acoustic lens Do not use this probe with other equipment except for those specifically approved in the manual Use with unapproved equipment can result in an electric shock burn or oth...

Страница 30: ...etailed information contact a service support Classification MDD classification IIa Cleaning Applicable detergents are listed in the supplier s list Disinfection Applicable disinfectants are listed in the supplier s list Sterilization ETO gas sterilization Plasma sterilization Operating conditions Ambient temperature 10 40 C Contact surface temperature Temperature of examinee Max 42 C Relative hum...

Страница 31: ...ts listed below are seriously tested and approved for use with the Magnetic sensor attachment and the Spacer for EZU RV2S Product name manufacturer purpose Cidezyme ENZOL Johnson Johnson Cleaner Meliseptol BV Tücher B Braun Disinfectant STERANIOS 2 ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plusTM 28 Johnson Johnson Disinfectant CIDEX OPA Johnson Jo...

Страница 32: ...res 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 nation...

Страница 33: ... 27 Q1E EP1234 29 26 24 Unit mm 2900 Fig 17 Dimensions ...

Страница 34: ... 28 E Q1E EP1234 18 61 Fig 18 External view of the probe EUP O732T with the Magnetic Sensor Attachment Option Unit mm ...

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