Hitachi C42 Instruction Manual Download Page 5

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Q1E-EP1359

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

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.

Summary of Contents for C42

Page 1: ...chi 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 in dex 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: ...ve 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 which...

Page 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 ...

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: ...l Surface 5 3 Operation Procedure 6 4 Option of C42 Probe 8 4 1 Magnetic sensor 8 5 Reprocessing Procedure 13 5 1 Point of use Pre cleaning 16 5 2 Containment and transportation 16 5 3 Manual Cleaning and disinfection 16 5 4 Drying 20 5 5 Inspection 20 5 6 Packaging 20 5 7 Sterilization 20 5 8 Storage 22 6 Maintenance and Safety Inspection 23 7 Safety Precautions 24 8 Specifications 25 8 1 Probe 2...

Page 7: ...his probe and the ultrasound diagnostic scanner enable image diagnosis 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 m...

Page 8: ...obe 1 5 Option 1 5 1 Needle Guide Bracket EZU PA532 1 Needle guide bracket 1 piece 2 Brush 1 piece 3 Instruction manual 1 copy Please refer to the instruction manual of needle guide bracket EZU PA532 about the method of handling cleaning disinfecting and sterilizing the needle guide bracket EZU PA532 1 5 2 Magnetic Sensor Attachment Magnetic Sensor Attachment Part number For using without Biopsy G...

Page 9: ...ect window appears on the first use and the selected bracket is automatically selected after the first use If the bracket is changed to the other bracket please change the name of the bracket displayed on the monitor to the name of the other bracket Otherwise there is a risk of injury due to biopsy failure caused by the use of the wrong type of needle guide bracket 5 Before performing a biopsy dis...

Page 10: ...t 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 Applied part Immersible part IPX7 Head Magnetic sensor attachment Option Magnetic sensor attachment with needle guide bracket Option ...

Page 11: ...ces 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 for any crack def...

Page 12: ...tions 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 Right left orientation mark Index mark Fig 2 Relationship between t...

Page 13: ...on the examination site and adjust the probe s position for a clear view of the desired image 6 After using the probe and the magnetic sensor attachment 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 and the Magnetic sensor attachment in the environment indic...

Page 14: ...he image according to the instructions given in the operation manual for the ultrasound diagnostic scanner 3 To use Real time Virtual Sonography RVS attach the magnetic sensor as shown below a The magnetic sensor attachment is available in two different types whether it is used with the needle guide bracket or not Select on of the following attachment When not using the Needle guide bracket When u...

Page 15: ...r 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 When not using the Needle guide bracke...

Page 16: ...n Fig 5 When using a Needle Guide Bracket When not using a Needle Guide Bracket Fig 5 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 17: ...ng the magnetic sensor from the probe is as follows a Push the magnetic sensor attachment and release it from the probe as shown in Fig 6 When not using a Needle Guide Bracket When using a Needle Guide Bracket Push here Push here Fig 6 How to release the Magnetic sensor attachment ...

Page 18: ... EP1359 b Release the magnetic sensor from the magnetic sensor attachment as shown in Fig 7 When not using the Needle guide bracket When using the Needle guide bracket Fig 7 How to release the magnetic sensor ...

Page 19: ...eedle guide bracket EZU PA532 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 befo...

Page 20: ...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 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 ...

Page 22: ...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 23: ...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 8 for 5 min 6 Visually chec...

Page 24: ...fectant 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 Temperature of disinfectant solution should be minimum 20 C The minimum contact time ...

Page 25: ...commended contact time which is 5 minutes 3 Rinse the Magnetic sensor attachment with deionized water for 1 minute alternatively immerse it in a tray filled with deionized water see Fig 8 for 5 min 4 Visually check the outer surface of the Magnetic sensor attachment for leavings of the disinfectant If necessary repeat the rinsing Fig 8 Immersion of the probe and the Magnetic sensor attachment Wate...

Page 26: ...covered 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...

Page 27: ...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 suffer s...

Page 28: ... 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 10 Sealing TYVEK Pouch Tray for sterilization Fig 11 Packaging in a tray Probe in the Pouch ...

Page 29: ...o 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 immediately contact a service support 3 Visually inspect the surface of the magnetic sensor attachment for any crack deformation or denaturalization If you find any da...

Page 30: ... 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 disinfect and sterilize the probe and the magnetic sensor attachment before the...

Page 31: ...epending 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 10 35 C Contact surface temperature ...

Page 32: ...infectant CIDEX Johnson Johnson Disinfectant CIDEX plusTM 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 Co...

Page 33: ...es 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 nationa...

Page 34: ... 28 Q1E EP1359 Unit mm Fig 12 Dimensions ...

Page 35: ... 29 Q1E EP1359 E Fig 13 External view with the Magnetic sensor attachment Fig 14 External view with the Magnetic sensor attachment and the Needle guide bracket ...

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