Hitachi EUP-C532 Instruction Manual Download Page 1

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Convex Array Probe

EUP-C532

INSTRUCTION MANUAL

Q1E-EP0416-8

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.

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Summary of Contents for EUP-C532

Page 1: ...itachi 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 ...

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: ...e 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 cause minor personal injury or property damage if the caution...

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: ...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...

Page 6: ...rocedure 5 4 Magnetic Sensor for EUP C532 7 4 1 Magnetic Sensor EZU RV2S 7 4 2 Magnetic Sensor EZU RV3S 13 5 Reprocessing Procedure 18 5 1 Point of use Pre cleaning 21 5 2 Containment and transportation 21 5 3 Manual Cleaning and disinfection 21 5 4 Drying 24 5 5 Inspection 25 5 6 Packaging 25 5 7 Sterilization 25 5 8 Storage 27 6 Maintenance and Safety Inspection 28 7 Safety Precautions 29 8 Spec...

Page 7: ...using ultrasonic 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 refl...

Page 8: ...2 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 if necessary sterilize the probe 1 5 Option 1 Magnetic Sensor Attachment 2 Spacer for EZU RV2S 3 Needle Guide Bracket EZU PA532 Please refer to the instruction manual of EZU PA532 for its handling and reprocessing Sterilization has not...

Page 9: ...tachment Option Spacer for EZU RV2S Option 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 Fig 1 External view of the EUP C532 Magnetic sensor attachment with needle guide bracket Option Applied part ...

Page 10: ...connect unauthorized devices or instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection for Material Surface 2 2 1 Visually inspect the surface of the probe and head housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use the probe and contact a service support 2 2 2 Visually inspect the Magnetic sensor attachment and ...

Page 11: ...d 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 Confirm the direction of the probe The relationship between the direction of the probe and image is shown in Fig 2 The Right left orientation mark on the image indicates the direction of the index mark of the probe Right left orientati...

Page 12: ...dure stated in 5 Reprocessing procedure every time immediately after completing the ultrasound examination 8 Store the probe the Magnetic sensor attachment and the Spacer for EZU RV2S in the environment 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...

Page 13: ...ig 3 is a magnetic sensor for the EUP C532 4 1 1 How to attach the Magnetic Sensor The Procedure of attaching the Magnetic sensor is as follows 1 Confirm that the probe the Magnetic sensor attachment and the Spacer for EZU RV2S are disinfected and if necessary sterilized 2 Connect the probe operate the ultrasound diagnostic scanner and adjust the image according to the instructions given in the op...

Page 14: ...without the Needle guide bracket Slit of the Magnetic sensor attachment Fig 5 How to attach the magnetic sensor Magnetic sensor attachment Magnetic sensor Fit the insertion direction Spacer for EZU RV2S Projected part of the magnetic sensor attachment Fit the insertion direction Projected part of the Magnetic sensor Magnetic sensor attachment Spacer for EZU RV2S Magnetic sensor Use without the Nee...

Page 15: ...n Fig 6 Use with the Needle Guide Bracket Use without the Needle Guide Bracket Fig 6 How to attach the Magnetic sensor attachment Index mark Fit the insertion direction Slit of the Magnetic sensor attachment Needle guide bracket Projected part of the Magnetic sensor attachment Fit the insertion direction ...

Page 16: ...he Magnetic sensor attachment to the probe in the incorrect direction otherwise it may result false diagnosis Never forget to attach the Spacer for EZU RV2S to the Magnetic sensor otherwise it may result in false diagnosis CAUTION ...

Page 17: ...ing the Magnetic sensor from the probe is as follow a Push the Magnetic sensor attachment and release it from the probe as shown in Fig 7 Use without the Needle Guide Bracket Use with the Needle Guide Bracket Push here Push here Fig 7 How to release the Magnetic Sensor Attachment ...

Page 18: ...2S is small please do not lose the spacer Clean disinfect and sterilize the Magnetic sensor attachment and the Spacer for EZU RV2S before the first use as there are not sterilized in the factory Use without the Needle guide bracket Use with the Needle guide bracket Fig 8 How to release the magnetic sensor CAUTION CAUTION ...

Page 19: ...ensor is as follows a The Magnetic sensor attachment comes in two different types whether or not to use the Needle guide bracket Select on of the following attachment Direction mark Fig 9 Magnetic sensor EZU RV3S Magnetic Sensor white Use without the Needle guide bracket Use with the Needle guide bracket EUP C532 indication EUP C532 GUIDE indication Fig 10 Selection of the Magnetic sensor attachme...

Page 20: ...nsor attachment Magnetic sensor Direction mark of the Magnetic sensor Place the direction mark upward as shown here Fit the insertion direction Magnetic sensor attachment Slit of the Magnetic sensor attachment Magnetic sensor Direction mark of the Magnetic sensor Place the direction mark upward as shown here Fit the insertion direction Magnetic sensor attachment Use without the Needle guide bracke...

Page 21: ...n Fig 12 Use with the Needle Guide Bracket Use without the Needle Guide Bracket Fig 12 How to attach the Magnetic sensor attachment Index mark Fit the insertion direction Slit of the Magnetic sensor attachment Needle guide bracket Projected part of the Magnetic sensor attachment Fit the insertion direction ...

Page 22: ...ng the Magnetic sensor from the probe is as follow a Push the Magnetic sensor attachment and release it from the probe as shown in Fig 13 Use without the Needle Guide Bracket Use with the Needle Guide Bracket Push here Push here Fig 13 How to release the Magnetic sensor attachment ...

Page 23: ...ttachment as shown in Fig 14 Clean disinfect and sterilize the Magnetic sensor attachment before the first use as there are not sterilize in the factory Use without the Needle guide bracket Use with the Needle guide bracket Fig 14 How to release the magnetic sensor CAUTION ...

Page 24: ...uring 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 ca...

Page 25: ...ow 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 op...

Page 26: ...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 27: ...eaning 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 tank for rinsing with deionized tap wat...

Page 28: ...he probe should be left in the detergent solution according to the specified contact time of the detergent manufacturer 4 Wipe the un immergible parts of the probe with a soft cloth dipped with the detergent solution 5 Rinse the probe with running tap water for 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 15 for 5 min 6 Vis...

Page 29: ...ficiency service life and contact time 2 Confirm the concentration of the disinfectant before immersing the probe Although Cidex OPA does not need to be diluted it is recommended to use test strips to verify the concentration The test strips can indicate whether or not the concentration is above the Minimum Effective Concentration MEC Please also note the expiration date of the test stripes Temper...

Page 30: ...ay filled with deionized water see Fig 15 for 5 min 4 Visually check the outer surface of the Magnetic sensor attachment and the Spacer for EZU RV2S 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 probe naturally in an ambient temperature betwee...

Page 31: ...bove 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 an appropriate sealing machine and it is important to confirm that the package is sealed completely If the sealing is not complete pack and reseal again ...

Page 32: ...Pa 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 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 ...

Page 33: ... plastic mesh wire for 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 Sealed Fig 17 Sealing TYVEK Pouch Tray for sterilization Fig 18 Packaging in a tray Probe in the Pouch ...

Page 34: ...d high temperature humidity and direct sunlight 2 Visually inspect the surface of the probe head the housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use the probe and immediately contact a service support 3 Visually inspect the surface of the Magnetic sensor attachment and the Spacer for EZU RV2S for any crack deformation or denaturalizat...

Page 35: ...ancy Do not expose the connector to water or other liquids The connector is not waterproof Do not hit or drop the probe The probe is easily damaged by mechanical shock Do not use detergents and disinfectants other than listed in 8 2 Suppliers list Use a sterile probe cover to avoid staining or damaging the acoustic lens Clean and sterilize the probe the Magnetic sensor attachment before the first ...

Page 36: ...em 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 Ambient temperature 25 35 C Contact surface temperat...

Page 37: ...Hygiene Disinfectant GmbH Incidur Spray Henkel Hygiene Disinfectant GmbH STERANIOS 2 ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant Virkon S ANTEC Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plus Johnson Johnson Disinfectant CIDEX OPA Johnson Johnson Disinfectant Tristel 1 Day Tristel Company Disinfectant Tristel Multi Shot Tristel Company Disinfectant ALKACIDE ALKAPHARM Disinfectant...

Page 38: ...sures 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 nati...

Page 39: ... 33 Q1E EP0416 Unit mm Fig 19 Dimensions ...

Page 40: ... 34 Q1E EP0416 Fig 20 External view with the Magnetic sensor attachment EUP C532 ...

Page 41: ... 35 Q1E EP0416 Fig 21 External view with the Magnetic sensor attachment and the Needle guide bracket EUP C532 GUIDE E ...

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