Hitachi C22P, Instruction Manual

Page 1: ...nsible 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 EP1457 7 Hitachi Ltd 2013 2017 All rights reserved 0123 ...

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: ...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...

Page 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...

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: ...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 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 31 5 4 Automated cleaning and disinfection 34 5 5 Drying 35 5 6 Packaging 35 5 7 Assembly and Inspection 35 5 8 Storage 35 6 Mainte...

Page 7: ...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 boundari...

Page 8: ...he HITACHI ultrasound 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 C22P are as follows 1 Probe 1 piece 2 Attachment 1 piece 3 Instruction Manual 1 copy ...

Page 9: ...GUIDE COVER KIT 610 579 or 610 608 directly from CIVCO MEDICAL INSTRUMENTS or an authorized CIVCO distributor 1 5 4 GENERAL PURPOSE Ultra Pro 3 DISPOSABLE STERILE ULTRASOUND NEEDLE GUIDE COVER KIT 610 901 Option 1 5 5 Purchase the Ultra Pro 3 NEEDLE GUIDE COVER KIT 610 901 directly from CIVCO MEDICAL INSTRUMENTS or an authorized CIVCO distributor Sterilization has not been made to the probe the at...

Page 10: ...sed 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 Scan head Immersible part IPX7 Attachment Applied part Needle Guide Bracket EZU PA7C2 Connector Un immersible part Fig 1 External View ...

Page 11: ...n for Material Surface 2 2 1 Probe Visually check the surface of the probe head the attachment 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 a st...

Page 12: ...biopsy guideline See Fig 2 Before use make sure there is no damage to the surface to which the needle cannula is attached and the needle guide works properly 9 Test needle Sterile water Water temperature see 2 2 2 2 Biopsy guide line a dotted line Right left orientation mark Needle echo a solid line Fig 2 Echo image of the test needle ...

Page 13: ...indicated on the monitor The needle guide angle is engraved on bracket See Fig 3 5 Visually inspect the cover to ensure that there are no defects or holes Do not use cover if it has any holes and tears 21 Needle guide angle is engraved Needle guide angle Fig 3 Needle guide angle ...

Page 14: ...and 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 4 The relationship between the 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 Relations...

Page 15: ...indicated in 6 Maintenance and Safety Inspection Do not use the probe if the image and the frequency do not match the probe An incorrect acoustic output can result in burns or other injuries to the patient Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output There is the possibility that the patient s tissues could be affected For details about the acou...

Page 16: ...c sensor into the attachment with the correct direction as shown in Fig 7 2 Insert the hold of the attachment into the projected part of the probe Never attach the Attachment to the probe in the incorrect direction otherwise it may result in false diagnosis Magnetic sensor attachment Magnetic sensor Direction mark of the magnetic sensor Place the direction mark upward as shown here Fig 7 How to at...

Page 17: ...ide out the attachment toward the direction B as shown in Fig 8 2 Release the Magnetic sensor from the groove of the attachment as shown in Fig 9 Clean and sterilize the Magnetic sensor before the first use as it is not sterilized in the factory Press this area A B Fig 8 How to release the attachment from the probe Slide the attachment in this direction Fig 9 How to release the Magnetic Sensor fro...

Page 18: ... 3 Attaching the needle guide to the bracket 5 Fit the needle insert corresponding to the gauge number of the needle to be used to the needle guide following 3 3 3 Attaching the needle guide to the bracket 6 Confirm that the needle guide angle corresponds to the angle indicated on the monitor The needle guide angle is engraved on bracket following 3 3 4 Setting the needle guide angle 7 In the case...

Page 19: ...he acoustic jelly accessory to the ultrasound diagnostic 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 ...

Page 20: ...IDE 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...

Page 21: ...that 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 a...

Page 22: ...sually 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 th...

Page 23: ...dle guide onto the needle guide attachment area of the bracket See Fig 14 2 Push the lock toward the bracket to secure the lock Make sure the needle guide is firmly attached to the bracket See Fig 15 Needle guide Needle guide attachment area Lock Fig 14 Attaching the needle guide Lock Needle guide Fig 15 Attaching the needle guide ...

Page 24: ...arrow tips See Fig 16 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 and the attachment and perform the cleaning and high level disinfection of the needle guide bracket Needle guide Needle insert Fig 16 Attaching the needle insert ...

Page 25: ...appropriate angle of the bracket Needle guide angles are engraved on the bracket See Fig 17 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 17 Setting the needle guide angle ...

Page 26: ... 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 27: ...his 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 contac...

Page 28: ...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 29: ...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 T...

Page 30: ...atively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 18 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 Please no...

Page 31: ...r the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 18 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 18 for 5 min 5 Visually check the outer surface of the pr...

Page 32: ...e also covered with a 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 shou...

Page 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...

Page 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 20 Sealing TYVEK Pouch Tray for sterilization Probe in the Pouch Fig 21 Packaging in a tray ...

Page 35: ...s 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 Figure 22 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 dam...

Page 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 ...

Page 37: ...ve 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 s instructions Ple...

Page 38: ... of the detergent manufacturer regarding application dilution and contact time 1 The temperature of the detergent 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 Separate the needle guide brack...

Page 39: ...structions of the disinfectant manufacturer regarding application concentration microbiological efficiency service life and contact time 2 Immerse all parts of the needle guide bracket into the disinfectant see Fig 22 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 pa...

Page 40: ...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...

Page 41: ...acket The needle guide bracket is not applied to any sterilization procedure If sterilization procedure is performed to it it may suffer serious damage and become unusable 6 Maintenance and Safety Inspection 1 After using the probe and the attachment they should be cleaned and disinfected or sterilized according to 4 Reprocessing Procedure then store them in a cool and dark place avoid high temper...

Page 42: ... operation and perform the inspection cleaning and disinfection or sterilization according to section 2 Inspection before Use and section 4 Reprocessing Procedure When using ultrasound contrast agent follow the supplied documentation Unexpected accidents could result Check the state of the patient and take appropriate precautions to avoid side effects During a biopsy use sterilized physiological s...

Page 43: ...e acoustic lens of the probe is manufactured very thin and delicate to get the high resolution Therefore in case of wiping out the ultrasound jelly or cleaning the surface of the acoustic lens please use the soft cloth or tissue paper and handle with care Do not use this probe with other equipment except for those specifically approved in the manual Use with unapproved equipment can result in an e...

Page 44: ...n 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 Plasma sterilization Operating conditions Ambient temperature 10 40 C Contact surface temperature max 42 C Temperature o...

Page 45: ...S 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 sterilize WAVICIDE 01 Mediacal Chemical Corp Disinfectant sterilize Please contact your local distributor for a current version of the Disinfectant Sterilization Method...

Page 46: ...E Ultra Pro II DISPOSABLE STERILE ULTRASOUND NEEDLE GUIDE COVER KIT 610 579 or 610 608 CIVCO MEDICAL INSTRUMENTS Needle Guide and Cover GENERAL PURPOSE Ultra Pro 3 DISPOSABLE STERILE ULTRASOUND NEEDLE GUIDE COVER KIT 610 901 CIVCO MEDICAL INSTRUMENTS Needle Guide and Cover Cidezyme Johnson Johnson Enzymatic detergent Cidex OPA Johnson Johnson Disinfectant Cidex Plus 28day solution Johnson Johnson ...

Page 47: ...res 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 nation...

Page 48: ... 42 Q1E EP1457 Unit mm Fig 23 Dimensions ...

Page 49: ... 43 Q1E EP1457 Unit mm Fig 24 External view with the attachment ...

Page 50: ... 44 Q1E EP1457 Unit mm Fig 25 Dimensions with the Needle Guide Bracket ...

Page 51: ... 45 E Q1E EP1457 Fig 26 External view with Ultra Pro II Needle Guide cover kit Unit mm ...