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S21 Probe

INSTRUCTION MANUAL

Tokyo , Japan

Q1E-EP1377-5

Notes for operators and responsible maintenance personnel

䖩

Please read through this Instruction Manual carefully prior to use.

䖩

Keep this Instruction Manual together with the system with care to
make it available anytime.

0123

Содержание S21

Страница 1: ...i Ltd 2013 2017 All rights reserved Notes for operators and responsible maintenance personnel 䖩 Please read through this Instruction Manual carefully prior to use 䖩 Keep this Instruction Manual together with the system with care to make it available anytime 0123 ...

Страница 2: ... 81 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: ...uestions 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...

Страница 4: ...l 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 d...

Страница 5: ...IED 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 wit...

Страница 6: ...ion for Material Surface 4 3 Operation Procedure 5 4 Cleaning Disinfection and Sterilization 6 4 1 Point of use Pre cleaning 9 4 2 Containment and transportation 9 4 3 Manual Cleaning and disinfection 9 4 4 Drying 12 4 5 Inspection 12 4 6 Packaging 12 4 7 Sterilization 13 4 8 Storage 15 5 Maintenance and Safety Inspection 15 6 Safety Precautions 16 7 Specifications 17 7 1 Probe 17 7 2 Suppliers Li...

Страница 7: ...c 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 reflected by bounda...

Страница 8: ...s x Transcranial Never use the probe for following applications 1 Direct contact to the heart 2 Biopsy to the heart 3 Direct contact to the eye 1 4 Composition The probe components of S21 Probe are as follows 1 Probe 1 piece 2 Instruction Manual 1 copy Sterilization has not been made to the probe shipped from the factory Prior to use of it be sure to clean disinfect and sterilize it WARNING CAUTIO...

Страница 9: ...e part Immersible part IPX7 Fig 1 External View 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 Head Connector Cable Applied part ...

Страница 10: ...on of appropriate connection 1 Confirm that the system is correctly operating Refer to the instruction manual for the ultrasound diagnostic scanner 2 Do not attach or connect unauthorized devices nor instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection of material surface Visually check the surface of the probe head housing and cable for any crack scratch or denaturaliza...

Страница 11: ... image is shown in Fig 2 The right left orientation mark on the image indicates 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 then store it in an adequate place 6 ...

Страница 12: ... C during reprocessing Ǧ 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...

Страница 13: ...elow 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 ...

Страница 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 ...

Страница 15: ...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 disinfection optional 1 additional...

Страница 16: ...e diluted detergent solution see Fig 3 Wipe 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...

Страница 17: ...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 3 Set a clock to insure the recommended contact tim...

Страница 18: ...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 barrier s...

Страница 19: ...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...

Страница 20: ...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 ...

Страница 21: ...nspection 1 After using the probe it should be cleaned and disinfected and sterilized according to 4 Cleaning Disinfection and Sterilization then store it in a cool and dark place avoid high temperature and humidity direct sunlight 2 Visually inspect the surface of the probe head housing cable and connector for any crack scratch or denaturalization If you find any damage do not use the probe and c...

Страница 22: ...tment to the patient 兟 By examination of an early pregnancy the exposure time shall be as short as possible Start examination with acoustic output power set to L Low 兟 The probe connector is not water proof Do not allow liquid to contact the connector 兟 Do not drop hit or bent the probe 兟 Use only water detergents and disinfectants in the suppliers list 兟 Under sterile condition use appropriate pr...

Страница 23: ...on production and 䢢 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 temperature max 42 ...

Страница 24: ...istributor for a current version of the Disinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 8 Disposal of the probe Recycle or dispose this equipment properly in compliance with the Waste Management and Public Cleansing Law Before disposing the equipment disinfect or take other infection prevention measures Disposal of the equipment without taking the proper pre...

Страница 25: ... 19 Q1E EP1377 Unit mm Fig 7 Dimensions ...

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