Hitachi EUP-S70, Instruction Manual

Page 1: ...152 6 Hitachi Ltd 2013 2017 All rights reserved 0123 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 ...

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: ...stions 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 which will or c...

Page 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...

Page 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...

Page 6: ...n for Material Surface 3 3 Operation Procedure 4 4 Cleaning Disinfection and Sterilization 5 4 1 Point of use Pre cleaning 8 4 2 Containment and transportation 8 4 3 Manual Cleaning and disinfection 8 4 4 Drying 11 4 5 Inspection 11 4 6 Packaging 11 4 7 Sterilization 12 4 8 Storage 14 5 Maintenance and Safety Inspection 14 6 Safety Precautions 15 7 Specifications 16 7 1 Probe 16 7 2 Suppliers List...

Page 7: ...d 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 boundaries with different acoustic characteristics acoustic impedance within the body 3 The transducer is also us...

Page 8: ... 1 copy 1 5 Construction Connector Head Cable 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 Immersible part IPX7 Un immersible Fig 1 External View Applied part ...

Page 9: ...ction for appropriate connection 2 1 1 Check that the system is correctly operating Refer to the instruction manual for the main unit 2 1 2 Do not attach or connect unauthorized devices nor instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection of material surface 2 2 1 Visually check the surface of the probe head housing and cable for any crack scratch or denaturalization...

Page 10: ...g 2 The right left orientation mark on the image indicates the direction of the index mark on the probe 4 Use under sterile condition protecting the probe by using covers is recommended Some Latex material may create allergic reaction Please use allergy free material covers 5 After the use of the probe it should be cleaned and disinfected and or sterilized immediately and then store it in an adequ...

Page 11: ...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 12: ...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 13: ...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 14: ...eaning 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 wat...

Page 15: ...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 immersible parts of the probe wit...

Page 16: ...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 4 Set a clock to insure the recommended contact tim...

Page 17: ...ch 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 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 barrie...

Page 18: ...0S 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 operation data of st...

Page 19: ...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 TYVEK Pouch Fig 4 Packaging in the pouch Probe TYVEK Pouch Sealed Fig 5 Sealing Probe Fig 6 Packaging in a tray Probe in the Pouch Tray for sterilization ...

Page 20: ...ection 1 Daily visually check the surface of the probe head housing cable and connector for any crack scratch or denaturalization If you find damage do not use the probe and immediately contact a service support 2 After the use of the probe it should be cleaned and disinfected and sterilized following 4 Cleaning and disinfection and Sterilization then store it in a cool and dark place avoid high t...

Page 21: ...rly pregnancy the exposure time shall be as short as possible Start examination with acoustic output power set to L Low The probe connector is not water proof Do not allow liquid to contact the connector Do not drop hit or bent the probe Use only water detergents and disinfectants in the suppliers list Between use store the probe holder of scanner Under sterile condition use appropriate protection...

Page 22: ...tem 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 Plasma sterilization Operating conditions Ambient temperature 25 35 C Contact surface temperature max 42 C temperat...

Page 23: ...iene GmbH Disinfectant Incidur Spray Henkel Hygiene GmbH Disinfectant STERANIOS 2 ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant Virkon S ANTEC Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plus Johnson Johnson Disinfectant CIDEX OPA Johnson Johnson Disinfectant ALKACIDE ALKAPHARM Disinfectant ALKAZYME ALKAPHARM Cleaner Please contact your local distributor for a current version of the...

Page 24: ...s 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 national...

Page 25: ... 19 E Q1E EP1152 Fig 7 Dimensions Unit mm ...