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Q1E-EP1451

5. Cleaning, Disinfection and Sterilization

The probe and accessory must be reprocessed after each use. Refer
to the reprocessing instruction in this chapter.

WARNINGS

‐

The probe is delivered unsterile. Prior to the
first use, reprocess 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 Sterile Supply
Department (CSSD) to an operating room. Be careful
not to damage the sterile pouch or container during
transportation.

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Содержание C41L47RP

Страница 1: ...tachi 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: ...e support The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning indicates the presence of a hazard which may result in severe personal injury substantial property damage or death if the warning is ignored CAUTION Caution indicates the presence of a hazard which will or can cause minor personal injury or property damage if the caution is ...

Страница 4: ...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 keep away from high temperature high humidity or direct sunlight Contains or ...

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: ...1 4 Option of C41L47RP Probe 13 4 1 Magnetic sensor 13 5 Cleaning Disinfection and Sterilization 15 5 1 Point of use Pre cleaning 18 5 2 Containment and transportation 18 5 3 Manual Cleaning and disinfection 19 5 4 Drying 22 5 5 Inspection 23 5 6 Packaging 23 5 7 Sterilization 24 5 8 Storage 26 6 Cleaning Disinfection and Sterilization of EZU PA3U 27 6 1 Point of use Pre cleaning 28 6 2 Containmen...

Страница 7: ... 1 Daily Inspection 33 7 2 Store 33 8 Safety Precautions 34 9 Specifications 36 9 1 Probe 36 9 2 Puncture Guide Fixture EZU PA3U 37 9 3 Suppliers List 37 9 4 Suppliers List for EZU PA3U 38 10 Disposal of the probe 38 ...

Страница 8: ...onic 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 bou...

Страница 9: ...tal Biopsy with a Puncture Guide Fixture Never use the probe for following regions 1 The heart Do not contact directly 2 The eyeball 1 4 Components Components of C41L47RP 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 the probe be sure to clean disinfect and sterilize it WARNING CAUTION ...

Страница 10: ...cover lubrication free probe cover which is dry type is recommended Lubrication may cause a deterioration of the probe surface And latex rubber may create allergic reactions use of non allergic probe cover is strongly recommended Take care for the handling of used probe cover 1 5 3 Magnetic sensor attachment Magnetic sensor attachment is needed for Real time Virtual Sonography RVS It is use to fix...

Страница 11: ...ad Applied part Band groove 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 cannot be cleaned by water Cable Fig 1 External view Connector Un immersible part Magnetic sensor attachment Option ...

Страница 12: ...iagnostic scanner to display the Needle guide line Refer to the operation manual for the ultrasound diagnostic scanner Keep the probe head in the water and insert a puncture needle in the Puncture Guide Fixture Then confirm that the needle is inserted smoothly and the echo of the needle is displayed on the dot line Needle guide line on the monitor 2 2 Inspection for Material Surface 2 2 1 Visually...

Страница 13: ...ting a patient from infection and the probe cover should be allergy free material to avoid allergic reaction 3 Connect the probe to the ultrasound diagnostic scanner and operate the scanner and adjust the image according to the instructions given in the operation manual for the ultrasound diagnostic scanner 4 The relationship between the direction of the probe and the right left orientation mark o...

Страница 14: ...propriate treatment to the patient 5 Insert the probe gentry and adjust the probe s position for a clear view of the desired image 6 After using the probe clean and disinfect or sterilize the probe immediately If RVS is carried out clean and disinfect or sterilize the Magnetic sensor attachment 7 Store the probe and the Magnetic sensor attachment in the environment indicated in 7 Maintenance and S...

Страница 15: ...A3U When the needle guideline is displayed numeric value is displayed on the upper right of the US image This numeric value means the distance between the surface of acoustic lens and the needle guideline see the figure in the next page Regarding the needle guideline refer to the instruction manual of the ultrasound scanner that the ultrasound probe is connected to The numeric value on the image c...

Страница 16: ...e needle echo at each distance overlaps with the correspondent needle guideline Water temperature depends on the type of the ultrasound diagnostic scanner connected to the probe If the type of the scanner is EUB series HI VISION series or Noblus set water temperature at room temperature For the other type of the scanner set it at 40 degrees Celsius It is fixed to 10mm position Biopsy Needle Numeri...

Страница 17: ...terile probe cover to the probe is recommended 2 Fit the groove of the Puncture Guide Fixture to the projection on the probe See Fig 4 3 Screw the Puncture Guide Fixture to attach to the probe firmly Visually inspect that there is no hole in the probe cover Puncture Guide Fixture EZU PA3U Probe cover Projection Fig4 How to attach the EZU PA3U Groove screw ...

Страница 18: ... back side of the puncture guide 2 Slide guide groove in the depth on demand 3 Tighten thumbscrew for fixing guide groove The Following figure is an example that guide groove of 14G is combined with the depth of 30mm Thumbscrew Guide groove Fig5 How to adjust Puncture Guide Fixture EZU PA3U ...

Страница 19: ... needle cannula of the electrosurgical unit while using the Puncture Guide Fixture as a guide be careful not to damage the insulation coating of the needle cannula When inserting or removing the needle cannula into or from the needle guide you may damage the insulation coating of the needle cannula which may cause a burn to tissue contacting the exposed section of the insulation coating 5 Use a ne...

Страница 20: ...ction as shown in Fig 6 Never attach the Magnetic sensor attachment to the probe at the incorrect direction otherwise it may result in false diagnosis 3 Attach the Magnetic sensor attachment to the probe as shown in Fig 7 Do not put your fingers between the Magnetic sensor attachment and the probe when attaching the Magnetic sensor attachment to the Probe Fig 6 How to attach the Magnetic sensor Di...

Страница 21: ... as shown in Fig 8 2 Detach the Magnetic sensor from the Magnetic sensor attachment as shown in Fig 9 Clean disinfect and Sterilize the Magnetic sensor attachment prior to first use as it is not sterilize when delivered Fig 9 How to release the Magnetic sensor from the Magnetic sensor attachment Fig 8 How to release the Magnetic sensor attachment from the probe CAUTION ...

Страница 22: ...eed 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 Sterile Supply Department CSSD to an operating ...

Страница 23: ...w 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 ope...

Страница 24: ...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 25: ...ities B Magnetic sensor attachment 1 Remove the Magnetic sensor attachment and the magnetic sensor from the probe 2 Immerse the Magnetic sensor attachment in sufficient amount of high quality tap water Scrub it using soft cloth to remove all visible soil from its surface 5 2 Containment and transportation Putting the contaminated equipment into exclusive shock and damage proof container for transp...

Страница 26: ...ee also instructions of the manufacturer for the detergent and the disinfectant Manual Cleaning Prepare the detergent solution in a tank with cold water please follow the instructions of the detergent manufacturer regarding application dilution and contact time A C41L47RP probe 1 The temperature of the detergent solution should be between 15 30 C concentration is 1 6 Please note the minimum contac...

Страница 27: ... 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 magnetic sensor attachment into the diluted detergent solution Wipe it under the surface of the detergent solution with a soft cloth to remove all visi...

Страница 28: ...ration MEC Please also note the expiration 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 10 Set a clock ...

Страница 29: ...filled with deionized water see Fig 10 for 5 min 4 Visually check its outer surface for leavings of the disinfectant If necessary repeat the rinsing 5 4 Drying 1 Wipe the equipment with a single use fluff free wipe or towel to remove moisture from the surface of the equipment 2 Dry the equipment naturally in an ambient temperature between 15 30 C for a minimum of 4 hours Alternatively the equipmen...

Страница 30: ...sterile barrier Additionally the equipment can be placed on plastic mesh wires supplied for plasma sterilization and then packed as mentioned above 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 barrier should be sealed by an app...

Страница 31: ...ation 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 sterilizer are in conjunction with min ...

Страница 32: ...before sterilization is as follows 1 Put the probe into TYVEK pouch 2 Seal the TYVEK Pouch using a heat sealer Ensure that the seal is complete Probe TYVEK Pouch Probe TYVEK Pouch Sealed Fig 11 Packaging in the pouch Fig 12 Sealing ...

Страница 33: ...r 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 Probe in the Pouch Tray for sterilization Fig 13 Packaging in a tray ...

Страница 34: ... Central Sterile Supply Department CSSD to an operating room Be careful not to damage the sterile pouch or container during transportation Levels of reprocessing requirements Refer to the chapter 5 The flowchart of the reprocessing process of EZU PA3U is as follows Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning Manual Disinfection Drying Automated Cleaning Manual cleaning ...

Страница 35: ...5 2 6 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 medical device c Applicable brush Fig 14 Disassem...

Страница 36: ...tween 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 parts of the EZU PA3U into the diluted detergent solution Clean them under the surface of the detergent solution with a brush to remove all visible soil 3...

Страница 37: ...U PA3U for leavings of the disinfectant If necessary repeat the rinsing 6 4 Automated cleaning and disinfection The following items must be provided prior to automated cleaning and disinfection a Washer disinfector according to DIN EN ISO 15883 with chemo thermal program temperature max 60 C b Detergent Korsolex Endo Cleaner Bode Chemie 972 020 or another cleaning agent with approved material comp...

Страница 38: ...ing 55 15 2 Place the disassembled parts of EZU PA3U in the baskets of the washer disinfector Smaller parts like the screws must be placed in a strainer basket with lid 3 Close the door of the washer disinfector and start the chemo thermal program 4 Open the door after the process is done 5 Take the parts of EZU PA3U out of the washer disinfector and check that they are dry If not dry them as desc...

Страница 39: ...ation 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 Steam Autoclaving that is applicable to only EZU PA3U Temperature min 132 C Chamber Pressure 41 7 44 7psia 27 30psig or 3bar Exposure time Minimum 10 minutes ...

Страница 40: ...e the Puncture Guide Fixture and contact your local HITACHI distributor immediately 7 1 3 Visually inspect the surface of the Magnetic sensor attachment for any crack deformation or denaturalization If you find any damage do not use it and contact a service support immediately 7 2 Store After using the probe and accessory they should be cleaned and disinfected sterilized according to 5 Cleaning Di...

Страница 41: ... medical gloves during examination Conducting examinations with the bare hands can expose the operator to a risk of infection 8 Do not use the probe fallen on to floor Otherwise there is a risk of infection Stop the operation and perform the inspection cleaning and disinfection or sterilization according to section 2 Inspection before Use and section 4 Reprocessing Procedure 9 When using ultrasoun...

Страница 42: ...etic sensor attachment before the first use as it is not sterilized in the factory 7 Use only the soft cloth or tissue to clean the acoustic lens 8 Only a well trained physician should perform a biopsy 9 The Do not use this probe with other equipment except for those specifically approved in the manual Use with unapproved equipment can result in an electric shock burn or other injury to the patien...

Страница 43: ... 60601 2 37 See Main 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 Sterilization ETO gas sterilization Plasma sterilization Operating conditions Ambie...

Страница 44: ...h C41L47RP Probe Product name manufacturer purpose Cidezyme Johnson Johnson Enzymatic detergent STERANIOS 2 ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plus 28 Johnson Johnson Disinfectant CIDEX OPA Johnson Johnson Disinfectant HYAMINE SOLUTION RICCA CHEMICAL COMPANY Disinfectant STERIHYDE Maruishi Pharmaceutical Disinfectant sterilant WAVICIDE 01 Me...

Страница 45: ...d Probe and Accessory List 10 Disposal of the probe Recycle or dispose of equipment properly in compliance with your organizational rules and your local laws Before disposing of the equipment disinfect or take other infection prevention measures Disposal of the equipment without taking the proper preventative measures can lead to infection Waste Electrical and Electronic Equipment WEEE Directive T...

Страница 46: ... 39 Q1E EP1451 356 Φ22 8 28 Fig 15 External view of C41L47RP Probe Unit mm 2200 2200 ...

Страница 47: ... 40 Q1E EP1451 Direction of biopsy needle Not included as probe component 85 Fig 16 Dimension Diagram with the Puncture Guide Fixture EZU PA3U Unit mm ...

Страница 48: ... 41 Q1E EP1451 161 48 Fig 17 Dimension Diagram with the Magnetic sensor attachment Unit mm E ...

Страница 49: ......

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