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C22K

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

‐

EP1389

‐

5

©Hitachi,

Ltd.

2013,2017.

All

rights

reserved.

1
2
3
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Содержание C22K

Страница 1: ...sponsible 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 EP1389 5 Hitachi Ltd 2013 2017 All rights reserved ...

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: ...uestions 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...

Страница 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...

Страница 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...

Страница 6: ...tion before Use 4 2 1 Inspection for Appropriate Connection 4 2 2 Inspection for Material Surface 4 3 Operation Procedure 5 4 Cleaning Disinfection and Sterilization 6 4 1 Point of use Pre cleaning 7 4 2 Containment and transportation 7 4 3 Manual Cleaning and disinfection 8 4 4 Drying 9 4 5 Inspection 9 4 6 Packaging 10 4 7 Sterilization 11 4 8 Storage 13 5 Maintenance and Safety Inspection 13 6 ...

Страница 7: ...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 boundaries wit...

Страница 8: ...ncture adapter MP 2781 5 1 Puncture adapter unit MP 2781 5 MB 1 set 2 Adjustment hexagon screwdriver 1 piece 3 Instruction manual 1 copy 1 5 3 Puncture adapter MP 2781 25 1 Puncture adapter unit MP 2781 25 MB 1 set 2 Adjustment hexagon screwdriver 1 piece 3 Instruction manual 1 copy 1 5 4 CIVCO Bracket CIV 614 108 Please refer to the instruction manual of option about the method of handling cleani...

Страница 9: ...nal View Immersible part IPX7 Cable Connector Un immersible part Head Applied part 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 cannot be cleaned by water ...

Страница 10: ... the instruction manual for the ultrasound diagnostic scanner 2 Do not attach or connect unauthorized devices or instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection for Material Surface Visually inspect the surface of the probe head housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use the probe and immediately c...

Страница 11: ...on of the index mark of the probe 5 Use under sterile condition protecting the probe by using covers is recommended Some Latex material may create allergic reaction Please use allergy free material covers 6 After using the probe perform the reprocessing procedure in accordance with the procedure stated in 4 Reprocessing Procedure every time immediately after completing the ultrasound examination 7...

Страница 12: ... during 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 responsi...

Страница 13: ...ith gauze pad and remove superficial visible impurities 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 cleaning Manual Dis...

Страница 14: ...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 Figure 3 Wipe the immersible part of the probe under the surface of the dete...

Страница 15: ...material compatibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 3 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 3 for 5 min 5 Visually check the ...

Страница 16: ...stic 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 should be sealed by an appropriate sealing machine and it is important to confirm that th...

Страница 17: ...e 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 STERRAD systems are manufactu...

Страница 18: ...Seal the TYVEK Pouch using a heat sealer Ensure that the seal is complete 3 Put the sealed pouch into a tray or plastic mesh wire for sterilization TYVEK Pouch Fig 4 Packaging in the pouch Probe TYVEK Pouch Sealed Fig 5 Sealing Probe Fig 6 Packaging in a tray Probe in the Pouch Tray for sterilization ...

Страница 19: ...ection 1 After using the probe the probe should be cleaned and disinfected and sterilized according to 4 Reprocessing Procedure store the probe in a cool and dark space to 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 a...

Страница 20: ... immediately and take an appropriate treatment to the patient By examination of an early pregnancy the exposure time shall be as short as possible Start examination with acoustic output power set to L Low 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 disinf...

Страница 21: ...ed in the suppliers list Sterilization ETO gas sterilization Plasma sterilization Operating conditions Ambient temperature 10 35 C Contact surface temperature temperature of examinee max 42 C Relative humidity 30 85 Storage conditions Temperature 10 55 C Relative humidity 10 95 subject to no condensation 8 Suppliers List The products listed below are seriously tested and approved for use with C22K...

Страница 22: ...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...

Страница 23: ... 17 E Q1E EP1389 Fig 7 Dimensions Unit mm ...

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