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Q1E-EP1011

Definition of symbol

The following symbol is also used for HITACHI Ultrasound Probes.

Location Symbol

Definition

Probe connector

This instrument complies with Directive
93/42/EEC relating to Medical Device and

Directive 2011/65/EU relating to RoHS

Probe connector

IPX7

IPX7 mark
See section 1.6.

Probe connector

Type BF APPLIED 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

Upper Limit of Temperature;

The probes that are applicable to Ethylene

Oxide Gas Sterilization use symbol of “Upper
Limit of Temperature: 55 degrees”.

Probe connector

Do not waste the instrument as general waste.

Comply with a local regulation.

Probe connector

Rx Only

By prescription only. U.S. Federal Law restricts

this device to sale on order of a physician only.

Содержание EUP-C715

Страница 1: ...11 7 Hitachi 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: ...stions 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 c...

Страница 4: ... 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 dustproof 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: ... 5 4 Magnetic Sensor for EUP C715 7 4 1 Magnetic Sensor EZU RV2S 7 4 2 Magnetic Sensor EZU RV3S 10 5 Cleaning Disinfection and Sterilization 13 5 1 Point of use Pre cleaning 16 5 2 Containment and transportation 16 5 3 Manual Cleaning and disinfection 17 5 4 Drying 20 5 5 Inspection 21 5 6 Packaging 21 5 7 Sterilization 22 5 8 Storage 24 6 Maintenance and Safety Inspection 25 7 Safety Precautions ...

Страница 7: ...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 reflected ...

Страница 8: ... from the factory Prior to use of the probe be sure to clean disinfect and sterilize the probe 1 5 Option 1 Magnetic Sensor Attachment 2 Spacer for EZU RV2S 3 Needle Guide Bracket EZU PA7C1 Please refer to the instruction manual of the needle guide bracket EZU PA7C1 about the method of handling cleaning and sterilizing the needle guide bracket EZU PA7C1 Sterilization has not been made to the magne...

Страница 9: ...ble part IP40 Magnetic sensor attachment 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 EUP C715 Applied part ...

Страница 10: ...es 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 immediately 2 2 2 Visually inspect the magnetic sensor attachment and the spacer for...

Страница 11: ...ding to the instructions given in the operation manual for the ultrasound diagnostic scanner with which the probe is used as connected 3 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 Fig 2 Relationship between the directions of the...

Страница 12: ... and adjust the probe s position for a clear view of the desire image 6 After using the probe the magnetic sensor attachment and the spacer for EZU RV2S perform the reprocessing procedure in accordance with the procedure stated in 5 Reprocessing procedure every time immediately after completing the ultrasound examination 7 Store the probe the magnetic sensor attachment and the spacer for EZU RV2S ...

Страница 13: ... Fig 3 4 1 1 How to attach the Magnetic Sensor The procedure of attaching the magnetic sensor is as follows 1 Attach the spacer for EZU RV2S to the magnetic sensor 2 Insert the magnetic sensor EZU RV2S into the magnetic sensor attachment with the correct direction as shown in Fig 4 2 1 Magnetic sensor EZU RV2S black Spacer for EZU RV2S Fit the insertion direction Projected part of the Magnetic sen...

Страница 14: ... 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 Fig 5 How to attach the Magnetic sensor attachment Projected part of the Magnetic sensor attachment Index mark Fit the insertion direction 3 CAUTION ...

Страница 15: ...agnetic sensor from the magnetic sensor attachment as shown in Fig 7 and release the spacer for EZU RV2S from the magnetic sensor The spacer for EZU RV2S 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 they are not sterilized in the factory Fig 7 How to release the Magnetic sensor Fig 6 How to r...

Страница 16: ...ollows 1 Attach the magnetic sensor into the probe with the correct direction as shown in Fig 9 Magnetic sensor EZU RV3S White Direction mark of the Magnetic sensor Place the direction mark upward as shown here Projected part of the Magnetic sensor attachment Fit the insertion direction Fig 9 How to attach the Magnetic sensor Fig 8 Magnetic sensor EZU RV3S Sensor white Direction mark ...

Страница 17: ...c sensor attachment in the index mark of the probe Never attach the magnetic sensor attachment to the probe in the incorrect direction otherwise it may result in false diagnosis Fig 10 How to attach the Magnetic sensor attachment Projected part of the Magnetic sensor attachment Index mark Fit the insertion direction CAUTION ...

Страница 18: ...attachment and release it from probe as shown in Fig 11 2 Release the magnetic sensor from the magnetic sensor attachment as shown in Fig 12 Clean disinfect and sterilize the magnetic sensor attachment before the first use as they are not sterilized in the factory Fig 12 How to release the Magnetic sensor Fig 11 How to release the Magnetic sensor attachment CAUTION ...

Страница 19: ...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 st...

Страница 20: ...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...

Страница 21: ...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 22: ...ings of ultrasound jelly B Magnetic sensor attachment and Spacer for EZU RV2S 1 Remove the magnetic sensor attachment the magnetic sensor and the spacer for RV2S from the probe 2 Immerse the magnetic sensor attachment and the spacer for RV2S 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 Puttin...

Страница 23: ...otective glasses see 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 EUP C715 1 The temperature of the detergent solution should be between 15 30 C concentration is 1 6 Please note the mi...

Страница 24: ...n 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 Immerse the magnetic sensor attachment and the spacer for EZU RV2S into the diluted detergent solution Wipe it under the surface of the detergent soluti...

Страница 25: ...ion 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 13 Set a clock to ...

Страница 26: ...rnatively immerse it in a tray filled with deionized water see Fig 13 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 probe with a single use fluff free wipe or towel to remove moisture from the surface of the probe 2 Dry the probe naturally in an ambient temperature between 15 30 C for a minimum of 4 hours Alterna...

Страница 27: ...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 an appropria...

Страница 28: ...ization 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 mi...

Страница 29: ...ging procedure 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 14 Packaging in the pouch Fig 15 Sealing ...

Страница 30: ...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 16 Packaging in a tray ...

Страница 31: ... avoid 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 contact a service support immediately 3 Visually inspect the surface of the magnetic sensor attachment and the spacer for EZU RV2S for any crack deformation or denatura...

Страница 32: ...e treatment to the patient Keep the acoustic power low and minimize the ultrasound exposure time for the examination of an early pregnancy 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 Supplier s list Use a sterile pro...

Страница 33: ...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 Ambient temperature 25 35 C Contact s...

Страница 34: ...sinfectant 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 ALKAZYME ALKAPHARM Cleaner Please contact your local distributor for a current version of th...

Страница 35: ... 29 Q1E EP1011 Unit mm Fig 17 Dimensions ...

Страница 36: ... 30 Q1E EP1011 Fig 18 External view with the Magnetic sensor attachment E ...

Страница 37: ......

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