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-1-

MN1-5831 Rev.5

1. General Information

General information for the probe is provided below

1-1. Intended use

This probe is intended for use by a doctor when placed in direct contact with human internal organs during surgery for
ultrasonic observation.

This probe can also be used for neurosurgery application if our specified transducer cover is mounted on the probe.

Please note that this probe is not allowed to be used for neurosurgery application in Japan. Regarding the precautions for
neurosurgery applications, please refer to the section 4-7.
Please refer to the ultrasound diagnostic instrument

instruction manual used with this probe for the probe intended use

information.
Regarding with the connectable instrument, please refer to section

2-1. Specifications

of this manual.

Warning

Do not use this equipment for other than its intended use.

Otherwise it could cause burns or other injuries to the patient or operator.

1-2. Classification of ME equipment

This probe is classified as follows according to IEC60601-1.

Please refer to the section 2-1 for the range of applied part, the parts treated as applied part, and the range of IPX7.

• Classification based on the degree of protection against electric shock

........ Type BF applied part

• Classification for protection against ingress of liquids

..................................

IPX7 (Watertight equipment)

• Operation mode

............................................................................................... Continuous operation

• Method of sterilization

.................................................................................... Refer to the separate “Instruction Manual

Cleaning, Disinfection and Sterilization

”

1-3. Standard components

The standard components of S31KP probe are as follows.

Probe

S31KP ...................................................................1 set

Puncture adapter

MP-2450-MB ........................................................1 set

Needle stopper

MP-2477 ................................................................1 set

Depth gause

MP-2450-DG

........................................................1 piece

Storage tray

MP-2698 ................................................................1 set

Adjustment hexagon screwdriver

...............................................................................1 piece

Storage case

...............................................................................1 set

Instruction manual

• Specification

MN1-5831..............................................................1 copy

• Safety

MN1-5986 .............................................................1 copy

• Cleaning, Disinfection and Sterilization

MN1-6000 .............................................................1 copy

Содержание S31KP

Страница 1: ...nnel Please read through this Instruction Manual as well as the separate Instruction Manual Safety MN1 5986 and Cleaning Disinfection and Sterilization MN1 6000 carefully prior to use Keep this Instruction Manual together with the ultrasound diagnostic instru ment for any future reference Hitachi Ltd 2014 2017 All rights reserved ...

Страница 2: ...ii MN1 5831 Rev 5 ...

Страница 3: ...prevent hazards and injuries to the operator or patients Danger Indicates an imminently hazardous situation which if not avoided will result in death or serious injury to the operator or patient Warning Indicates a potentially hazardous situation which if not avoided could result in death or serious injury to the operator or patient Caution Indicates a potentially hazardous situation which if not ...

Страница 4: ...probe 8 3 1 1 Visual check 8 3 1 2 Confirmation of cleaning and sterilization 8 3 1 3 Operation check 8 3 2 Start up check of the puncture adapter 9 3 2 1 Visual check 9 3 2 2 Mechanical inspection of the puncture adapter 9 3 2 3 Verification of operation 9 3 3 Checking the needle echo 10 3 3 1 Check setup 10 3 3 2 Checking the needle echo 11 3 4 Adjusting the needle direction 12 3 4 1 When the ne...

Страница 5: ...er and the depth gauge 16 4 5 Removal of the puncture adapter 18 4 6 When using the probe for neurosurgery applications 19 4 6 1 How to attach the transducer cover 19 4 6 2 How to remove the transducer cover 19 4 6 3 Puncture 19 4 6 4 Remove the puncture adapter 20 4 7 Precautions when using the probe in neurosurgery applications 21 ...

Страница 6: ...vi MN1 5831 Rev 5 ...

Страница 7: ...her than its intended use Otherwise it could cause burns or other injuries to the patient or operator 1 2 Classification of ME equipment This probe is classified as follows according to IEC60601 1 Please refer to the section 2 1 for the range of applied part the parts treated as applied part and the range of IPX7 Classification based on the degree of protection against electric shock Type BF appli...

Страница 8: ...rilant Whole the probe is able to immerge into the liquids by putting the connector of the ultrasound probe to the waterproof case WP 001 as below table Precautions about the waterproof case please refer to the instruction manual Accessory for reprocessing by liquid detergent disinfectant or sterilant Product Name Product No Waterproof case WP 001 ...

Страница 9: ...our local Hitachi representative Field of view 90 Frequency 5 0 MHz Cable length 2 5 m Service life 3 years Applied part Probe tip including ultrasonic radiation part see the section 2 2 Parts treated as applied parts Cable up to 0 2 m length from the probe tip IPX7 range See Figure 1 In case that not putting the waterproof case to the ultrasound probe connector In case that putting the waterproof...

Страница 10: ...figure below Remarks The dimensions are within 10 of the indicated values Figure 2 External View of the puncture adapter 2 1 3 Transducer cover when using the probe in neurosurgery application CIVCO Transducer cover 610 956 610 956 EU This transducer cover can be used in neurosurgery applications and it is Pyrogen free If you are unable to obtain the transducer cover locally please contact your lo...

Страница 11: ...n on the display This mark also helps attach the puncture adapter Probe tip This is the grip of the probe Cable Ultrasonic signal is transferred through the cable Connector The connector is the part which is connected to the ultrasound diagnostic instrument Caution Do not pull bend twist or apply excessive force to the cable The probe may malfunction due to cable disconnection Do not subject the u...

Страница 12: ...ghten the screw securely referring to 4 2 Attaching of the puncture adapter Needle groove setting knob Adjust the needle groove width to the diameter of a puncture needle to be used Turning clockwise widens the needle groove Refer to the section 4 3 Setting the needle groove Lever locking knob This is used to prevent unintentional movement of the release lever Securely tighten this knob by turning...

Страница 13: ...n procedure 3 1 3 Operation check Connect the probe to the ultrasound diagnostic instrument and check that the displayed scan type and frequency correspond to those of the probe Check also that there is no abnormality in the image Remark Please refer to the documentation supplied with the ultrasound diagnostic instrument for how to connect the probe and information displayed on the monitor If the ...

Страница 14: ...as looseness backlash and immobility When the release lever is pressed with the lever locking knob loosen the puncture needle can be removed from the puncture adapter The release lever does not move when the lever locking knob is tightened securely The puncture adapter is firmly attached to the probe A puncturing needle that passes through the needle groove moves smoothly in the puncturing directi...

Страница 15: ...the needle groove Check that the puncture needle has no bending or other defects 3 Connect the probe to the ultrasound diagnostic instrument Turn on the ultrasound diagnostic instrument to display the puncture guideline on the monitor screen Remarks For details of the puncture guideline refer to the instruction manual of the ultrasound diagnostic instrument Caution Use warm water at 40 C in the ch...

Страница 16: ...e following points The needle echo matches with the puncture guideline The echo of the entire needle is displayed fully and clearly Image on the monitor screen Needle echo Puncture guide line Figure 6 Checking needle echo 2 3 If the needle echo does not match the puncture guideline or is weak refer to section 3 4 Adjusting the needle direction and fine tune the needle direction so that it is displ...

Страница 17: ...ent hexagon screwdriver to loosen the needle angle adjusting screw and align the needle echo with the puncture guideline Needle angle adjusting screw Adjustment hexagon screwdriver Loosen Puncture needle Figure 7 Adjustment of needle angle 3 4 2 When the needle echo is weak As shown below use the supplied adjustment hexagon screwdriver to loosen the needle echo level adjusting screw and display th...

Страница 18: ... of the puncture adapter 2 Wash and sterilize the probe to be used in accordance with its usage purpose Warning The equipment must be washed and sterilized before use Be sure to always properly wash and sterilize after use Otherwise an infection can occur Note that the equipment is not sterilized when shipped from the factory Before using the equipment for the first time be sure to wash and steril...

Страница 19: ... supplied with the ultrasound diagnostic instrument Caution Do not operate the probe with excessive force Use with excessive force could result in injury to the patient Scan for minimum time necessary at the lowest possible acoustic output Acoustic output may affect the patient s internal tissues For details about the acoustic output please refer to the documentation supplied with the ultrasound d...

Страница 20: ...ve then attach the puncture adapter to the probe Front mark Protrusion Guide hole Fit Fit Guide groove Figure 9 Attachment and fixture of puncture adapter 1 2 Check that the front mark and the protrusion on the probe fit the guide hole and guide groove on the adapter respectively Then tighten the fixing knob Fixing knob Tighen the knob Figure 10 Attachment and fixture of puncture adapter 2 ...

Страница 21: ...nd the depth gauge follow the procedure below 1 Display the puncture guideline on the monitor screen 2 Adjust the position and angle of the probe so that the target puncture region appears over the puncture guideline on the display and then freeze the image 3 Measure the distance a from the reference point of the puncture guideline on the monitor screen to the target puncture region Use the punctu...

Страница 22: ...of the needle stopper Needle stopper Knob Puncture needle Depth gauge 6 5 4 V groove Notch Groove Figure 12 Attaching the needle stopper and puncturing needle 7 Move the tip of the puncture needle to the scale position corresponding to the distance a measured in step 3 above 8 Tighten the knob of the needle stopper to lock the needle stopper to the puncturing needle Puncture needle Needle stopper ...

Страница 23: ...nce b Distance a Distance from the reference point on the puncture guideline to the target puncture region The 0 index line on the depth gauge corresponds to the reference point of the puncture guideline Distance b Distance from the end of the needle locking base on the puncture adapter to the reference point on the puncture guideline On the depth gauge this corresponds to the distance from the 0 ...

Страница 24: ... of the probe Apply some sterilized acoustic medium Transducer cover Figure 15 How to attach the transducer cover 4 6 2 How to remove the transducer cover 1 To prevent infection use surgical gloves to remove the used transducer cover from the probe 2 Dispose of the used surgical gloves and transducer cover in a manner that prevents infection and in accordance with the rules of the medical facility...

Страница 25: ...ure needle Operate the release lever of the puncture adapter and open the needle groove Insert the puncture needle into the needle groove in the direction of the arrow To prevent the contact of the puncture needle tip to the transducer cover Figure 17 Attach the puncture adapter 2 3 Verify that there is nothing wrong with the transducer cover before puncturing Do not use the transducer cover if th...

Страница 26: ...omy If the transducer cover breaks it may cause harm to the patient Verify that there is nothing wrong with the transducer cover and that the puncture adapter is properly attached on the transducer when puncturing If you attach the puncture adapter incorrectly it may come off during the procedure or it may be punctured into a non intended area Refer to the details on Section 4 6 3 Puncture Properl...

Страница 27: ... 21 MN1 5831 Rev 5 MN1 5831 Rev 5 ...

Страница 28: ...ev 5 17 08 31 Manufacturer Hitachi Ltd 2 16 1 Higashi Ueno Taito ku Tokyo 110 0015 Japan Contact 81 3 6284 3668 http www hitachi com businesses healthcare index html Overseas Offices 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 ...

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