Page 1: ...tors 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 EP1028 5 Hitachi Ltd 2013 2017 All rights reserved ...
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: ...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 can caus...
Page 4: ...eanings of them Explanation of Symbol Symbol Descriptive Content Manufacturer Company Name and Address Hitachi Ltd 2 16 1 Higashi Ueno taito ku Tokyo 110 0015 Japan 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 and dark dry environment to avoid high temp...
Page 5: ...robe connector Type BF APPLIED 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 Do not waste the instrument as general waste Comply with a local regulation Probe con...
Page 6: ... Connection 2 2 2 Inspection for Material Surface 2 3 Operation Procedure 3 4 Cleaning and Disinfection 4 4 1 Point of use Pre cleaning 5 4 2 Containment and transportation 5 4 3 Manual Cleaning and disinfection 6 4 4 Drying 7 4 5 Inspection 7 5 Maintenance and Safety Inspection 8 5 1 Daily check 8 6 Safety Precautions 9 7 Specifications 10 7 1 Probe 10 7 2 Suppliers List 11 8 Disposal of the prob...
Page 7: ...ibration 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 used to receive reflected ultrasonic waves The transducer vibrates mechanically due to the received ultrasonic wav...
Page 8: ... attach or connect unauthorized devices or instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection for Material Surface Visually check the surface of the probe head housing and cable for any crack scratch or denaturalization 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 im...
Page 9: ... in Fig 2 4 Before a diagnosis put a probe cover to the tip of the probe certainly Before putting a probe cover put sterilized acoustic jelly to the tip of the probe and attach a probe cover to the tip of the probe closely 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 then store it in an ad...
Page 10: ...r container during transportation Levels of reprocessing requirements Depending on the application of the product and with regard to risk evaluation the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as uncritical semi critical or critical Supporting information concerning this topic is listed in the table below The user ...
Page 11: ...the probe with gauze pad and remove superficial visible impurities 4 2 Containment and transportation Putting the contaminated equipment into exclusive shock and damage proof container for transportation is recommended It is recommended that instruments are reprocessed as soon as possible and not later than 4 hours after usage Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning...
Page 12: ...tergent solution should be between 15 30 C concentration is 1 6 Please note the minimum contact time of the detergent in the manufacturer s instruction If a differing detergent is used please also note the approved material compatibility for the medical device 2 Immerse the immersible part of the probe without connector into the diluted detergent solution see Fig 3 Wipe the immersible part of the ...
Page 13: ...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 deionized water see Fig 3 for 5 min 5 Visually check the outer surface of the probe for leavings of the disinfectant If necessary repeat the...
Page 14: ...d cable for any crack scratch or denaturalization If you find damage do not use the probe and immediately contact a service support 2 After using the probe it should be cleaned and disinfected according to 4 Cleaning and disinfection then store it in a cool and dark place avoid high temperature and humidity direct sunlight ...
Page 15: ... output power set to L Low The probe connector is not waterproof 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 uses store the probe holder of scanner Under sterile condition use appropriate protection for probe and cable Some Latex material may create allergic reactions The acoustic lens of t...
Page 16: ...n Unit manual Applicable system 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 Operating conditions Ambient temperature 25 35 C Contact surface temperature temperature of examinee ...
Page 17: ...or a current version of the ʺDisinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 8 Disposal of the probe Recycle or dispose equipment properly in compliance with your organizational rules and your local laws Before disposing equipment disinfect or take other infection prevention measures Disposal of equipment without taking the proper preventative measures can l...
Page 18: ... 12 Q1E EP1028 E 28 6 28 6 R12 5 2300 173 300 Fig 4 Dimensions of the probe Unit mm ...
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