Hitachi C41V Instruction Manual Download Page 1 | Manualshive

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C41V

Probe

INSTRUCTION

MANUAL

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.

Tokyo,

Japan

Q1E

‐

EP1363

‐

6

©

Hitachi,

Ltd.

2013,

2017.

All

rights

reserved.

0123

1
2
3
...
»

Summary of Contents for C41V

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 EP1363 6 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: ...support The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning indicates the presence of a hazard which may result in severe personal injury substantial property damage or death if the warning is ignored CAUTION Caution indicates the presence of a hazard which will or can cause minor personal injury or property damage if the caution is ig...

Page 4: ...hi Ltd 2 16 1 Higashi Ueno Taito ku TOKYO 110 0015 Japan 81 3 6284 3668 http www hitachi com businesses heal thcare 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 dark dry place to avoid high temperature humidity and direct sunlight Contain...

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: ... of Sterile Puncture Adapter EZU PA5V 8 3 3 Display of Needle Guide Line 9 4 Cleaning Disinfection and Sterilization 10 4 1 Point of use Pre cleaning 11 4 2 Containment and transportation 11 4 3 Manual Cleaning and disinfection 12 4 4 Drying 13 4 5 Inspection 13 4 6 Packaging 14 4 7 Sterilization 15 4 8 Storage 16 5 Maintenance and Safety Inspection 17 5 1 Daily Inspection 17 5 2 Storage 17 6 Safe...

Page 7: ...nic 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 boun...

Page 8: ...GYN organs Biopsy with a Sterile Puncture Adapter Transvaginal Transrectal Never use the probe for following regions 1 The heart Do not contact directly 2 The eyeball 1 4 Components Components of C41V Probe are as follows 1 Probe 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 sterili...

Page 9: ...graphy EZU TEBL2 This mechanical compression unit is used for tissue elasticity imaging by using the balloon attached to the probe that is connected to a Hitachi s digital ultrasound scanner system and electronic scanning ultrasound tomography system Please refer to the instruction manual of option about the method of handling cleaning and disinfection of EZU TEMC1 and EZU TEBL2 1 5 3 Condom or Pr...

Page 10: ...e 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 cannot be cleaned by water Fig 1 External view Cable Connector Immersible part IPX7 Applied part Un immersible part ...

Page 11: ...he scanner are appropriate for the probe Attach the Sterile Puncture Adapter on the probe Set the ultrasound diagnostic scanner to display the Needle guide line Refer to the operation manual for the ultrasound diagnostic scanner Keep the probe head in the water and insert a puncture needle in the Sterile Puncture Adapter Then confirm that the needle is inserted smoothly and the echo of the needle ...

Page 12: ... See Fig 2 5 Put a probe cover on the probe and draw the probe cover until the end of the probe shaft To avoid air bubbles be careful to press the probe cover gently against probe head and to keep jelly on the probe head If air bubbles appear on the probe head remove air bubbles by pushing jelly with finger See Fig 3 and Fig 4 Be careful with a probe cover made out of latex The latex may cause suc...

Page 13: ...red image By turning or tilting the probe a turn around imaging is possible If the image is insufficient use sterile saline solution This solution improves the contact between probe and organ 8 After using the probe clean disinfect and sterilize the probe immediately 9 Store the probe in the environment indicated in 5 Maintenance and Safety Inspection Sterilized tape Fig 5 ...

Page 14: ... open or minimal invasive surgery use the protection sleeve to cover probe and cable 1 Attach a sterile probe cover to the probe See 3 1 Connection and Settings 2 Put the picks of the Sterile Puncture Adapter to the grooves on the tip of the probe See Fig 6 3 Push the other end of the Sterile Puncture Adapter until fix the dents of the Sterile Puncture Adapter to the projection on the probe See Fi...

Page 15: ...nd diagnostic scanner NOTE The needle guide line will be displayed to provide a visual guide to the direction of the puncture needle pathway Be sure to check the actual location of the needle on the ultrasound image when performing the puncture operation The needle guide line can be displayed with this probe however some image display may not be appropriate for puncture procedure according to the ...

Page 16: ...uring transportation 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 responsibl...

Page 17: ...d remove superficial visible impurities and leavings of ultrasound jelly 4 2 Containment and transportation Putting the contaminated equipment into exclusive shock and damage proof container for transportation is recommended It is recommended that instruments are reprocessed as soon as possible and not later than 4 hours after usage Point of use Pre cleaning Manual Cleaning Rinsing after manual cl...

Page 18: ...5 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 immersible part of the probe without connector into the diluted detergent solution see Fig 8 Wipe the immersible part of the probe under the surface of the deter...

Page 19: ...r the material compatibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 8 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 8 for 5 min 5 Visually chec...

Page 20: ...ic 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 appropriate sealing machine and it is important to confirm that the pack...

Page 21: ...45 minutes Exposure Temperature 122 0 131 0 F equivalent of 50 55 C Sterilant gas 10 EO 90 HCFC Excess pressure 162 200 kPa Exposure time 120 125 min full cycle Post vacuum 8 26 kPa 2 times Aeration Temperature 50 55 C Time min 11 hours Plasma sterilization Sterilization Method Condition Plasma Sterilization STERRAD 50 100S or 200 Short Cycle Plasma Sterilization Sterrad NX or 100NX Standard cycle...

Page 22: ...nto a tray or plastic mesh wire for sterilization 4 8 Storage Store the equipment in a cool dustproof dry and dark space to avoid high temperature humidity and direct sunlight Limitations for the time for sterilized equipment belong to package TYVEK Pouch Fig 9 Packaging in the pouch Probe TYVEK Pouch Sealed Fig 10 Sealing Probe Fig 11 Packaging in a tray Tray for sterilization Probe in the Pouch ...

Page 23: ...ack scratch or denaturalization If you find any damage do not use the probe and contact a service support immediately 5 2 Storage After using the probe it should be cleaned and disinfected and sterilized following 4 Cleaning disinfection and Sterilization immediately Then store it in a cool and dark place avoid high temperature humidity and direct sunlight ...

Page 24: ...ons of the probe during surgical or minimal invasive procedures take care that electro cautery devices are out of range In case of using defibrillation take the probe out or away from the body 2 Keep the acoustic power low and minimize the ultrasound exposure time for the examination of an early pregnancy 3 Do not expose the connector to water or other liquids The connector is not waterproof 4 Do ...

Page 25: ...g 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 or Plasma sterilization Operating conditions Ambient temperature 10 35 C Contact surface temperature Temp...

Page 26: ...ble needle gauge 16G to 19G Materials Bio compatible allergy free components Classification MDD classification IIa Package 24 Sterile Puncture Adapters for single use Sterilization method Sterilized with gamma irradiation Operating conditions Temperature 10 40 C Storage conditions Temperature 10 40 C ...

Page 27: ...r local distributor for a current version of the Disinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 8 Disposal of the probe Recycle or dispose this equipment properly in compliance with the Waste Management and Public Cleansing Law Before disposing the equipment disinfect or take other infection prevention measures Disposal of the equipment without taking the p...

Page 28: ... 22 Q1E EP1363 Fig 12 External view of C41V Probe Unit mm ...

Page 29: ... 23 E Q1E EP1363 Fig 13 External view of C41V Probe with Sterile Puncture Adapter EZU PA5V ...

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