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Q1E-EP1412

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 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 (operative
application)

Cleaning

Disinfection

(Disinfectant with

virucidal effect -

minimum)

Sterilization

The flowchart of the reprocessing process 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

Содержание EUP-B712

Страница 1: ... 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 EP1412 4 Hitachi Ltd 2013 2017 All rights reserved 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: ...have any questions 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 whi...

Страница 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...

Страница 5: ...ltage 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...

Страница 6: ...ion 23 4 3 Manual Cleaning and disinfection 23 4 4 Drying 26 4 5 Inspection 26 4 6 Packaging 26 4 7 Sterilization 26 4 8 Storage 28 5 Cleaning and Disinfection of EZU PA7C2 29 5 1 Point of use Pre cleaning 31 5 2 Containment and transportation 31 5 3 Manual Cleaning and disinfection 32 5 4 Automated cleaning and disinfection 35 5 5 Drying 36 5 6 Packaging 36 5 7 Assembly and Inspection 36 5 8 Stor...

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: ...diagnostic scanner Biopsy with Biopsy Attachment General abdominal organs 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 Components The probe components of EUP B712 are as follows 1 Probe 1 piece 2 Magnetic Sensor Attachment 1 piece 3 Spacer for EZU RV2S 3 pieces 4 Instruction Manual 1 copy WARNING ...

Страница 9: ...NERAL PURPOSE Ultra Pro 3 DISPOSABLE STERILE ULTRASOUND NEEDLE GUIDE COVER KIT 610 901 Option Purchase the Ultra Pro 3 NEEDLE GUIDE COVER KIT 610 901 directly from CIVCO MEDICAL INSTRUMENTS or an authorized CIVCO distributor 1 Sterilization has not been made to the probe the Needle guide bracket the Magnetic sensor attachment and the Spacer for EZU RV2S shipped from the factory Prior to use of the...

Страница 10: ... 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 Immersible part IPX7 Option Magnetic Sensor Attachment Option Spacer for EZU RV2S Applied part Option Needle Guide Bracket EZU PA7C2 Connector Scan head Un immersible part ...

Страница 11: ...s 2 2 Inspection for Material Surface 2 2 1 Probe Visually check the surface of the probe head housing and cable for any crack scratch or denaturalization If you find any damage do not use the probe and contact a service support immediately 2 2 2 Needle Guide Bracket EZU PA7C2 1 Visually check the surface of the needle guide bracket for any crack scratch denaturalization or deformation 2 Fill ster...

Страница 12: ...ee Fig 3 4 Visually inspect the cover to ensure that there are no defects or holes Do not use the cover if it has any holes and tears 2 2 3 Magnetic sensor attachment and Spacer for EZU RV2S Visually inspect that the surface of the Magnetic sensor attachment and the Spacer for EZU RV2S for any crack deformation or denaturalization Because the Spacer for EZU RV2S is small please do not lose the spa...

Страница 13: ... adjust the image all according to the instructions given in the operation manual for the ultrasound diagnostic scanner with which the probe is used as connected 3 Relationship between direction of the probe and the image is shown in Fig 4 The right left orientation mark on the image indicates the index mark on the probe Index mark Right Left orientation mark Probe Image Fig 4 Relationship between...

Страница 14: ...ide bracket to the probe following 3 2 1 Fitting the needle guide bracket to the probe Never apply excessive force to attach the needle guide bracket to the wrong position It may cause a hazard due to unstable biopsy 3 Fit the CIV Flex cover to the probe following 3 2 2 Placing the probe and bracket into a transducer cover 4 Attach the needle guide to the bracket following 3 2 3 Attaching the need...

Страница 15: ... the ultrasound scanner is not a sterilized one never use it 2 In order to make the dead angle of the needle as short as possible perform the biopsy operation with full display width Regarding how to adjust the display width refer to the operating manual of the scanner 3 Do not hold the needle cannula of the electrosurgical unit with metal tweezers forceps and the like Doing so may damage the insu...

Страница 16: ...COVER KIT is disposable and must not be reused 3 Sterilize disinfect the probe and disinfect the needle guide bracket when a cover tears 4 Confirm that the needle guide angle corresponds to the angle indicated on the monitor The needle guide angle is engraved on bracket Otherwise the biopsy guide line becomes inconsistent with the inserting position of the biopsy needle 5 When using the needle can...

Страница 17: ... the needle guide attachment area is positioned in the same direction as that of the needle guide bracket mount part side Never attach the needle guide attachment area at the reverse side of the needle guide bracket mount part Otherwise the biopsy guide line becomes inconsistent with the inserting position of the biopsy needle Needle guide bracket Needle guide bracket mount part Needle guide attac...

Страница 18: ...isually inspect the cover to ensure that there are no defects or holes Do not uses cover if it has any holes 1 Never use the acoustic gel that is enclosed in the main ultrasound system unit because it is not sterilized Use only sterile acoustic gel that is enclosed in CIVCO Ultra Pro II or Ultra Pro 3 Disposable Sterile Ultrasound Needle Guide Cover Kit If sterile acoustic gel is not enclosed in t...

Страница 19: ...te amount of gel inside the cover and or on the Probe head See Fig 9 2 Push the lock toward the bracket to secure the lock Make sure the needle guide is firmly attached to the bracket See Fig 10 Needle guide Needle guide attachment area Lock Fig 9 Attaching the needle guide Lock Needle guide Fig 10 Attaching the needle guide ...

Страница 20: ...Inspect the guide and cover assembly to ensure the needle path is clear of obstructions In case of bore a hole in the probe cover with a biopsy needle perform the cleaning and sterilization of the Probe the Magnetic Sensor Attachment and Spacer for EZU RV2S and perform the cleaning and high level disinfection of the needle guide bracket Needle guide Needle insert Fig 11 Attaching the needle insert...

Страница 21: ...opriate angle of the bracket Needle guide angles are engraved on the bracket See Fig 12 Do not place the knob on any positions between recesses of the bracket Otherwise the needle guide angle will be unstable Knob Recess of the bracket Needle guide angle are engraved Fig 12 Setting the needle guide angle WARNING ...

Страница 22: ...tic sensor with which the EUP B712 enables RVS Real time Virtual Sonography There are two types of Magnetic sensors EZU RV2S and EZU RV3S The Magnetic sensor EZU RV2S and the Magnetic sensor EZU RV3S are shown in Fig 13 and Fig 14 Projected part Sensor Black Fig 13 Magnetic Sensor EZU RV2S Direction mark Sensor White Fig 14 Magnetic Sensor EZU RV3S ...

Страница 23: ...attachment into the projected part of the probe 1 Never attach the Magnetic sensor attachment to the probe in the incorrect direction otherwise it may result in false diagnosis 2 Never forget to attach the Spacer for EZU RV2S to the Magnetic sensor otherwise it may result in false diagnosis Spacer for EZU RV2S Magnetic sensor attachment Fig 15 How to attach the Magnetic Sensor Attachment Projected...

Страница 24: ... slide out the attachment toward the direction B as shown in Fig 16 and release it from the probe 2 Release the Magnetic sensor from the groove of the attachment as shown in Fig 17 and release the Spacer for EZU RV2S from the Magnetic sensor A B Slide the attachment in this direction Fig 16 How to release the attachment from the probe Press this area Fig 17 How to release the Magnetic Sensor from ...

Страница 25: ...shown in Fig 18 2 Insert the hold of the attachment into the projected part of the probe Never attach the Magnetic sensor attachment to the probe in the incorrect direction otherwise it may result in false diagnosis Magnetic sensor attachment Magnetic sensor EZU RV3S white Direction mark of the EZU RV3S Place the direction mark upward as shown here Fig 18 How to attach the Magnetic Sensor Attachme...

Страница 26: ...de out the attachment toward the direction B as shown in Fig 19 2 Release the Magnetic sensor from the groove of the attachment as shown in Fig 20 Clean and sterilize the Magnetic sensor before the first use as it is not sterilized in the factory Press this area A B Fig 19 How to release the attachment from the probe Slide the attachment in this direction Fig 20 How to release the Magnetic Sensor ...

Страница 27: ... 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 ...

Страница 28: ...sing 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 operative application Cleaning Disinfection Disinfectant with virucidal effect minimum Sterilization The flowc...

Страница 29: ...d not later than 4 hours after usage 4 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...

Страница 30: ...ute alternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 21 for 5 min 6 Visually check the outer surface of the probe for cleanness If necessary use magnifying glass for visually check If there is still soil visible repeat all above steps B Attachment 1 The temperature of the detergent solution should be between 15 30 C concentration is 1 6...

Страница 31: ...atibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 21 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 21 for 5 min 5 Visually check the outer surfa...

Страница 32: ...vered 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 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 a...

Страница 33: ...surization 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 and max data applicable for the probe and the Attachment 2 Do not sterilize the probe and the Attachment by Steam Autoclaving If you autoclave them they suffers serious d...

Страница 34: ... mesh wire for sterilization 4 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 Sealed Probe Attachment Fig 23 Sealing TYVEK Pouch Tray for sterilization Probe in the Pouch Fig 24 Packaging in a tray ...

Страница 35: ...ns during all processes The needle guide bracket must be manually pre cleaned using ultrasound prior manual reprocessing as well as automated reprocessing and must be dismantled into single parts shown in Fig 25 Transportation before using EZU PA7C2 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 damag...

Страница 36: ... follows Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning Manual Disinfection Drying Automated Cleaning Manual cleaning and disinfection Washer Disinfector WD Automated Disinfection Rinsing after manual disinfection Packing Containment and transportation ...

Страница 37: ... Personal protective equipment gloves water repellent protective skirt face protection mask or protective glasses see also instructions of the manufacturer for the detergent and the disinfectant Pre Cleaning 1 Fill the ultrasound bath with the detergent The temperature of the detergent solution should be between 15 30 C concentration is 1 6 If a different detergent is used follow the manufacturer ...

Страница 38: ...terial compatibility for this medical device c Cleaning brushes if applicable d Two tanks one for cleaning and one for disinfection optional 1 additional tank for rinsing with deionized tap water sufficient size for immersion of the submergible part of the probe at full length e Soft fluff free cloth or single use towel f 50 ml syringe g Personal protective equipment gloves water repellent protect...

Страница 39: ... Brush the whole length of the cavity and the spiral spring of the needle guide bracket at least 5 times by using an applicable brush 5 Wipe the parts of the needle guide bracket under the surface of the detergent solution with a single use fluff free soft cloth to remove all visible soil Be sure that all grooves of the needle guide bracket are implemented during the cleaning process 6 All parts o...

Страница 40: ...to the disinfectant see Fig 25 Rinse the cavity of the needle guide bracket with 50 ml disinfectant solution Repeat this 4 times Set a clock to insure the recommended contact time which is 5 minutes 3 Rinse all parts of the needle guide bracket with deionized water for 1 minute alternatively immerse them in a tray filled with deionized water see Fig 25 for 5 min 4 Visually check the outer surface ...

Страница 41: ...r holding the dismantled small parts screws spring of the needle guide bracket 1 The parameter of the cleaning and disinfection of the device are as follows Program step water 40 l Dosage ml l Temp C time min Pre Rinse Cold water 5 Cleaning Deionized water 5 0 5 50 10 Rinse Deionized water 1 Disinfection Deionized water 10 1 55 5 Rinse Deionized water 1 Rinse Deionized water 55 1 Drying 55 15 Tabl...

Страница 42: ...sterile bag is recommended until using it for keeping cleaned and disinfected condition 5 7 Assembly and Inspection Assemble the needle guide bracket and inspect it for any damage such as crack scratch or deformation Do not use it if any damage is found 5 8 Storage Store the equipment in a cool dustproof and dark space to avoid high temperature humidity and direct sunlight Do not perform any steri...

Страница 43: ...d and high level disinfected according to 4 Reprocessing Procedure then store it in a cool and dark place avoid high temperature and humidity direct sunlight 4 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 contact a service support immediately 5 Visually inspect the surface of the...

Страница 44: ...the probe Use only water detergents and disinfectants in the suppliers list Under sterile condition use appropriate protection for probe and cable Some Latex material may create allergic reactions When the probe the Magnetic sensor attachment and the Spacer for EZU RV2S are delivered they are not cleaned disinfected and sterilized Before using them clean disinfect and if necessary sterilize them c...

Страница 45: ...duction and upgrade status for detailed information contact a service support Classification MDD classification IIa Cleaning Applicable detergents are listed in the supplier list Disinfection Applicable disinfectants are listed in the suppliers list Sterilization ETO gas sterilization and Plasma sterilization Operating conditions Ambient temperature 10 40 C Contact surface temperature Temperature ...

Страница 46: ...nt CIDEX OPA Johnson Johnson Disinfectant HYAMINE SOLUTION RICCA CHEMICAL COMPANY Disinfectant STERIHYDE Maruishi Pharmaceutical Disinfectant sterilize WAVICIDE 01 Mediacal Chemical Corp Disinfectant sterilize 610 002 Sterile 14 x 61cm 5 5 x 24 flat folded CIV Flex cover 3D CIVCO Medical Covers 610 542 Sterile 14 x 91 5cm 5 5 x 36 telescopically folded CIV Flex cover 3D CIVCO Medical Covers Please...

Страница 47: ...t Cidex OPA Johnson Johnson Disinfectant Cidex Plus 28day solution Johnson Johnson Disinfectant Cidex Johnson Johnson Disinfectant 9 Disposal of the probe Recycle or dispose of this 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 p...

Страница 48: ... 42 Q1E EP1412 Unit mm Fig 26 Dimensions ...

Страница 49: ... 43 Q1E EP1412 Unit mm Fig 27 External view with the Magnetic Sensor Attachment ...

Страница 50: ... 44 Q1E EP1412 Unit mm Fig 28 Dimensions with the Needle Guide Bracket ...

Страница 51: ... 45 E Q1E EP1412 Unit mm Fig 29 External view with Ultra Pro II Needle Guide cover kit ...

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