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L44 Probe

INSTRUCTION MANUAL

Tokyo , Japan

Q1E-EP1370-5

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 L44

Страница 1: ...chi 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: ...have any 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 whi...

Страница 4: ...ymbol 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 dry and dark pla...

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: ...rial surface 5 3 Operation Procedure 6 4 Option of L44 Probe 8 4 1 Elasto Coupler 8 5 Reprocessing Procedure 9 5 1 Point of use Pre cleaning 12 5 2 Containment and transportation 12 5 3 Manual Cleaning and disinfection 12 5 4 Drying 16 5 5 Inspection 16 5 6 Packaging 16 5 7 Sterilization 16 5 8 Storage 18 6 Maintenance and Safety Inspection 19 7 Safety Precautions 20 8 Specifications 21 8 1 Probe ...

Страница 7: ...sing 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 refle...

Страница 8: ...gland Biopsy with Coupler Attachment Never use the probe for following applications Direct contact to the heart Biopsy to the heart Direct contact to the eye 1 4 Components The components of L44 Probe are given below 1 Probe 1 piece 2 Instruction manual 1 copy 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 p...

Страница 9: ... of 20 to 22 gauge may not fit in the Needle guide 18G 3 Brush 5 pieces 4 Instruction manual 1 copy Please refer to the instruction manual of EZU PA7L1 about the method of handling cleaning and sterilizing the EZU PA7L1 Sterilization has not been made to the elasto coupler and the EZU PA7L1 shipped from the factory Prior to use of them be sure to clean disinfect and sterilize them A biopsy should ...

Страница 10: ...rt 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 Head Immersible part IPX7 Un immersible part Cable Connector Elasto coupler Option Applied part ...

Страница 11: ...s on the probe such as unauthorized biopsy attachments 2 2 Inspection of material surface 2 2 1 Visually 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 elasto coupler for any crack deformation or denaturalizat...

Страница 12: ...s 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 2 Relationship between the d...

Страница 13: ...nt 5 Place the probe on the examination site and adjust the probe s position for a clear view of the desired image 6 After using the probe 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 and the elasto coupler in the environment indicate...

Страница 14: ...the elasto coupler as shown below Attach the elasto coupler on the probe as straight as possible as shown in Fig 3 4 1 2 How to release the Elasto Coupler Release the Elasto coupler from the probe as shown in Fig 4 Elasto coupler Fig 3 How to attach the Elasto coupler Elasto coupler Fig 4 How to release the Elasto coupler ...

Страница 15: ...ocess 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 container to transport from Central Steri...

Страница 16: ...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...

Страница 17: ...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 18: ...as possible 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 me...

Страница 19: ...ternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 5 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 Elasto coupler 1 The temperature of the detergent solution should be between 15 30 C concentration is 1 6 Pl...

Страница 20: ... also consider the material compatibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 5 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 5 for 5 min 5 ...

Страница 21: ... 15 Q1E EP1370 Water Detergent Disinfectant Fig 5 Immersion of the probe and the elasto coupler ...

Страница 22: ...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...

Страница 23: ...0kPa 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 elasto coupler 2 Do not sterilize the probe and elasto coupler by Steam Autoclaving If you autoclave it it suffers se...

Страница 24: ...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 Fig 7 Sealing TYVEK Pouch Tray for sterilization Fig 8 Packaging in a tray Probe in the Pouch ...

Страница 25: ...ure and humidity direct sunlight 2 Visually inspect the surface of the probe head 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 elasto coupler for any crack deformation or denaturalization If you find any damage do not use the elasto couple...

Страница 26: ...y 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 8 2 Suppliers list Use a sterile probe cover to avoid staining or damaging the acoustic lens Clean disinfect and sterilize the probe and the elasto coupler before the first u...

Страница 27: ...m 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 10 35 C Contact surface temperatu...

Страница 28: ...ur local distributor for a current version of the Disinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 9 Disposal of the probe Recycle or dispose this equipment properly in compliance with the Waste Management and Public Cleaning Law Before disposing the equipment disinfect or take other infection prevention measures Disposal of the equipment without taking the p...

Страница 29: ... 23 Q1E EP1370 Unit mm Fig 9 Dimensions ...

Страница 30: ... 24 Q1E EP1370 Fig 10 External View with the Elasto coupler ...

Страница 31: ... 25 Q1E EP1370 ...

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