Hitachi EUP-OL334 Instruction Manual Download Page 1

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Laparoscopic Probe

EUP-OL334

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-EP0304-8

0123

Summary of Contents for EUP-OL334

Page 1: ...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 EP0304 8 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: ...oscopic ultrasound imaging procedure This instruction manual in no way presumes to provide instructions or recommendations in laparoscopic imaging techniques or protocol 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 d...

Page 4: ...on of 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 place and...

Page 5: ...tage 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: ...ating Controls 4 5 Pre use Inspection 5 6 Cleaning Disinfection and Sterilization 6 6 1 Point of use Pre cleaning 9 6 2 Containment and transportation 9 6 3 Manual Cleaning and disinfection 9 6 4 Drying 11 6 5 Inspection 12 6 6 Packaging 12 6 7 Sterilization 13 6 8 Storage 15 7 Operation 15 8 Maintenance and Safety Inspection 18 9 Storage 18 10 When Fault is Suspected 18 11 Specifications 19 12 Di...

Page 7: ...quid or other medium contacting the transducer 2 The emitted ultrasonic waves are reflected by boundaries with different acoustic characteristics acoustic impedance within the body 3 The transducer is also used to receive reflected ultrasonic waves The transducer vibrates mechanically due to the received ultrasonic waves and converts mechanical vibrations into electric energy Electric signals are ...

Page 8: ... Atmospheric pressure 70 106hPa 2 Equipment Composition 1 Laparoscopic probe 1 2 Carrying case 1 3 Instruction Manual 1 3 Component Description 3 Inserting section Applied part Fig 1 Component Description 10 Non watertight section 2 Articulating section 1 Transducer 8 System end connector 7 Cable 4 Grip section 5 Left lever 6 Right lever 9 Watertight section IPX7 ...

Page 9: ...n to connect this instrument with the ultrasound scanner unit 9 Watertight action Section that can be immersed in the sterilant solution and section cleaning solution 10 Non watertight action Section that should not be poured on section with water or the section sterilant solution or should not be immersed in it Otherwise it may be damaged Never immerse it in water or the sterilant solution Never ...

Page 10: ...the articulating mechanism The Laparoscopic Ultrasound probe is a precision equipment and care must be exercised to avoid damaging it The Laparoscopic Ultrasound probe should only be handled by trained personnel The left lever controls articulating in the up down plane Forward down backward up The right lever controls articulation in the left right plane Forward left backward right Refer to Fig 2 ...

Page 11: ...Any such damage could compromise the electrical safety of the probe or cause lacerations to the patient Inspect the probe cable for damage i e nicks cuts or tears in the cable jacket Check the control levers for proper operation The levers should move freely without binding and easily move the transducer through its full range of movement If any damage is detected do not use the probe There are no...

Page 12: ...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 room Be...

Page 13: ...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 contacts intracorporeal tissue directly...

Page 14: ...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 15: ... 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 device c Two tanks one for cleaning and one for disinfe...

Page 16: ... 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 probe with a soft cloth dipped with the detergent solution 5 Rins...

Page 17: ...ufacturer 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 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 deioniz...

Page 18: ...ier such as Polypropylene fleece or transparent package made from Polyethylene film and Tyvek and then place it into a tray The tray should be also covered with a sterile barrier 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 bar...

Page 19: ...tion 162 200kPa Depressurization 13 8kPa Relative humidity 40 90 Aeration is minimum 12 hours STERRAD systems are manufactured by Johnson Johnson This probe cannot put into STERRAD 50 system because the chamber is small for putting this probe 1 Before performing sterilization check that the operation data of sterilizer are in conjunction with min and max data applicable for the probe 2 Do not ster...

Page 20: ... Put the probe into TYVEK pouch 2 Seal the TYVEK Pouch using a heat sealer Ensure that the seal is complete 3 Put the sealed pouch into a tray or plastic mesh wire for sterilization Probe TYVEK Pouch Probe TYVEK Pouch Sealed Fig 4 Packaging in the pouch Fig 5 Sealing ...

Page 21: ...ion before use 3 Sterilization Follow 6 Cleaning Disinfection and Sterilization 4 Imaging a Connect the probe to the ultrasound scanner For connecting the probe refer to the instruction manual of the ultrasound scanner b Insert the probe into the 10mm 10mm 11mm or 10mm 12mm trocar and see Section 4 for controlling articulation to fit the probe to any diagnostic region c Operate the ultrasound scan...

Page 22: ...ny damage such as cracks or cuts or which cable jacket is broken If using as it is damaged electric shock may result Use certainly a sterilized probe cover in order to prevent infection and minimize sticking of body fluid to the probe We recommend CIVCO 610 941 latex free laparoscopic probe cover In case of using this probe cover 12mm trocar is recommended for use The probe is not sterilized when ...

Page 23: ...witch OFF For any model having more than two probe connectors select the other connector than that for the probe to be connected disconnected using the probe selection key to make Freeze ON Great care must be exercised to handle the probe Never give shock hit any hardware nor drop it Otherwise fault may result Do not use 5mm 10mm 5mm 11mm and 5mm 12mm trocars Using these may damage the probe Ultra...

Page 24: ...nsducer tip or probe cable to become pinched or otherwise damaged For proper storage a wall rack that securely holds the probe and protects it from impacts by other objects is recommended Do not store the Laparoscopic Ultrasound probe in areas subject to temperature extremes or direct sunlight 10 When Fault is Suspected When a fault is suspected check the following points When no abnormality is fo...

Page 25: ...iameter of inserting section 10 0mm Articulation Up down plane 90 Left right plane 90 Trocar cannula size See CAUTION below Outside view See Fig 7 The Laparoscopic Ultrasound probe is designed to fit standard 10mm 10 11mm and 10 12mm cannulas Do not use 5 10mm cannulas as these may cause damage to the articulating section of the probe CAUTION ...

Page 26: ...res Disposal of 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 national r...

Page 27: ... 21 Q1E EP0304 Fig 3 Dimensions Articulating section Transduc Unit mm Fig 7 Outside Dimensions E ...

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