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Hitachi Aloka Medical UST-9113P-3.5 Instruction Manual

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MN1-1014 Rev.14
MN1-1014 Rev.15
Puncture Electronic Convex Probe
UST-9113P-3.5
Instruction Manual
MN1-1014 Rev.15
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Summary of Contents for Hitachi Aloka Medical UST-9113P-3.5

  • Page 1 MN1-1014 Rev.14 MN1-1014 Rev.15 Puncture Electronic Convex Probe UST-9113P-3.5 Instruction Manual MN1-1014 Rev.15...
  • Page 2 MN1-1014 Rev.14...
  • Page 3 MN1-1014 Rev.14 Introduction This is an instruction for model UST-9113P-3.5, an ultrasound probe. Read the manual carefully before using the instrument. Take special note of the items in section 1, "Safety Precautions". Keep this manual securely for future reference. The CE mark on the probe indicates that this probe is valid when it is connected to equipment bearing the CE mark that is specified as available in section 2 of this document.

  • Page 4: Table Of Contents

    MN1-1014 Rev.14 CONTENTS 1. Safety Precautions 1-1. Intended use ........................1 1-2. Usage precautions ......................1 1-2-1. Warnings and safety information....................2 1-2-2. Puncture precautions ........................4 1-2-3. Washing, disinfection and sterilization precautions ............... 7 1-2-4. Labels ............................. 8 2. Specifications and Parts name 2-1.
  • Page 5 MN1-1014 Rev.14 4. Usage 4-1. Operation ........................23 4-2. Attaching of the puncture adapter ...................24 4-3..............24 Usage of the needle stopper and the depth gauge 4-4. Leaving the needle ......................27 4-5. Removal of the puncture adapter ..................27 4-6. Connecting to the ultrasound diagnostic instrument .............28 4-7.
  • Page 6 MN1-1014 Rev.14 8. Periodic Inspection 8-1. Safety tests of the probe ....................43 8-2. Testing of measurement tolerances .................44 ......................44 8-2-1. Conducting tests ......................44 8-2-2. Result judgment 8-3. Safety tests of the puncture adapter ................45 9. Configuration 9-1. Standard configuration ....................47 9-2.

  • Page 7: Safety Precautions

    MN1-1014 Rev. 14 1. Safety Precautions 1-1. Intended use This probe is intended for use by a doctor when placed to direct contact with the skin making ultrasonic observations of surrounding organs. It also enables the doctor to guide the puncture needle under the ultrasound guide into the patient's body. Caution Do not use this equipment for other than its intended purpose.

  • Page 8: Warnings And Safety Information

    MN1-1014 Rev. 14 1-2-1. Warnings and safety information Warning Follow the information in this manual and the documentation supplied with any equipment used together with this probe. Use that is not in accordance with the supplied documentation can result in a serious or moderate injury, equipment breakdown or physical damage that impairs operation.
  • Page 9 MN1-1014 Rev. 14 Caution Constantly check for anything abnormal about the patient’s condition, equipment. Continued use without noticing that an abnormal condition has occurred can result in an electric shock and injury to the operator or patient. If an abnormal condition occurs, immediately move the equipment away from the patient and stop use of the equipment.

  • Page 10: Puncture Precautions

    MN1-1014 Rev. 14 1-2-2. Puncturing precautions Warning Puncturing must be performed by a skilled doctor. Improper puncturing can injure the patient. Puncturing operations must be performed by a doctor who fully understands the characteristics of ultrasound diagnostics and who is skilled and has a thorough knowledge of puncture operations under an ultrasound guide.
  • Page 11 MN1-1014 Rev. 14 Warning Do not puncture the heart region. Puncturing the heart region may cause a micro electric shock. Check that no other organs lie in the puncture path. If another organ lies in the puncture path, an unintended body part can be punctured and cause an injury to the patient.
  • Page 12 MN1-1014 Rev. 14 Caution Handle the needle carefully to ensure that the probe, the puncture adapter, the needle stopper and the depth gauge are not damaged. Using the probe, the puncture adapter, the needle stopper and the depth gauge that has been damaged by a needle can result in an injury to the operator or patient.

  • Page 13: Washing, Disinfection And Sterilization Precautions

    MN1-1014 Rev. 14 1-2-3. Washing, disinfection and sterilization precautions Warning Wear protective gloves and other protective gear during washing, disinfection and sterilization. Handling of the equipment with your bare hands before disinfection or sterilization can result in an infection. After soaking in cleaning agents, thoroughly wash the equipment with running water. Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient.

  • Page 14: Labels

    MN1-1014 Rev. 14 1-2-5. Labels (1) Probe unit Label 1 Label 2 Label 3 Label 1 Electronic convex probe mark Frequency MH z...
  • Page 15 MN1-1014 Rev. 14 Label 2 This equipment complies with Directive 93/42/EEC relating to Medical Device. IPX7 mark IPX7 See section 2-2, “Specifications”. Type BF applied part Do not waste the instrument as general waste. Comply with a local regulation. See section 10. Safety warning sign Biohazard See section 5.
  • Page 16 MN1-1014 Rev. 14 (2) Storage case Label A Label B -10-...
  • Page 17 MN1-1014 Rev. 14 MN1-1014 Rev. 15 Label A Model Serial No. Label B 2012 This equipment complies with Directive 93/42/EEC relating to Medical Device. DATE OF MANUFACTURE (in case of 2012) 2012 MANUFACTURER -11-...
  • Page 18 MN1-1014 Rev. 14 -12-...

  • Page 19: Specifications And Parts Name

    MN1-1014 Rev. 14 2. Specifications and Parts name 2-1. Principles of operation This probe and the ultrasound diagnostic instrument enable image diagnosis using ultrasonic waves. These instruments operate under the principles described below. (1) When an electric pulse signal is applied from the transmitter to the transducer of the probe, the transducer operates by converting electrical vibrations to mechanical vibration energy for emitting pulse-shaped ultrasonic waves into the body part contacting the transducer or into liquid or other medium.

  • Page 20: Specifications

    MN1-1014 Rev. 14 2-2. Specifications 2-2-1. Specifications of the probe Application regions: Surface puncturing, abdomen, general areas Form of application to patient: Surface Connectable instruments: SSD-900, SSD-1000, SSD-3500, SSD-4000, SSD-α5, Prosound 6 Field of view: 60° Frequency: 3.5 MHz Cable length: 2.0 m Weight: 1060 g...

  • Page 21: Specifications Of The Puncture Adapter

    MN1-1014 Rev. 14 2-2-2. Specifications of the puncture adapter Material Polyacetal (Puncture adapter (the needle guide) ) Stainless steel (Puncture adapter (the knob), needle stopper, depth gauge) Puncture adapter, usable puncture needle size and diameter Standard MP-2480-G18 : 18G(1.26±0.02mm) Option MP-2480-G22 : 22G(0.71±0.02mm) MP-2480-G21 : 21G(0.81±0.02mm) MP-2480-G20 : 20G(0.88±0.02mm)

  • Page 22: Performance

    MN1-1014 Rev. 14 2-3. Performance For measurement tolerances, operating tolerances and other data, refer to the instruction manual for the ultrasound diagnostic instrument. 2-4. Names of each parts Cable Probe tip This cable propagates the ultrasonic This area is held during operation. signals that are sent and received.

  • Page 23: Environmental Conditions

    MN1-1014 Rev. 14 2-5. Environmental conditions Use and store the equipment under the following conditions. 2-5-1. Operating environmental conditions Ambient temperature: 10°C to 40°C 50°F to 104°F Relative humidity: 30% to 75% Atmospheric pressure: 700 hPa to 1060 hPa Altitude: 3,000 m or less 2-5-2.
  • Page 24 MN1-1014 Rev. 14 -18-...

  • Page 25: Preparations For Use

    MN1-1014 Rev. 14 3. Preparations for Use 3-1. Start up check of the probe 3-1-1. Visual check Visually check the probe tip, ultrasonic irradiation area, cable and connector. If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are found, do not use the equipment. 3-1-2.

  • Page 26: Start Up Check Of The Puncture Adapter

    MN1-1014 Rev. 14 3-2. Start up check of the puncture adapter 3-2-1. Visual check Check the puncture adapter is not in the abnormal conditions listed below. Abnormalities seen in visual such as deformation, cracking, abnormal gaps, damage, foreign matter • adhering, clogged guide holes, severe discoloration.

  • Page 27: Checking The Needle Echo

    MN1-1014 Rev. 14 3-3. Checking the needle echo 3-3-1. Check preparation (1) Required items (Depth of 20 cm or more) Warm water 40°C (104°F) Thermometer Probe Puncture adapter MP-2480-G18 (standard configuration) or others (user's selection of the options) Puncture needle Size : 18G (standard configuration) or others (depend on user's selection) Length : 150 mm to 200 mm...

  • Page 28: Checking The Needle Echo

    MN1-1014 Rev. 14 3-3-2. Checking the needle echo (1) Dip the probe tip into the warm water so that the needle echo is displayed. (2) Check the following points. • The needle echo matches with the puncture guide line. • The echo of the entire needle is displayed fully and clearly. Image on the monitor screen Needle echo Puncture guide line...

  • Page 29: Usage

    MN1-1014 Rev. 14 4. Usage 4-1. Operation Bring the ultrasonic irradiation area of the probe to contact with the skin surface. An image of the region of interest is displayed on the monitor of the ultrasound diagnostic instrument. For details on displaying and adjusting the screens, see the documentation supplied with the ultrasound diagnostic instrument.

  • Page 30: Attaching Of The Puncture Adapter

    MN1-1014 Rev. 14 4-2. Attaching of the puncture adapter (1) The knob tip is passed through the needle guide hole. Then attach the knob to the needle guide by turning the knob clockwise by six rotations or more. Needle guide hole Knob tip ①...
  • Page 31 MN1-1014 Rev. 14 (4) Loosen the knob of the needle stopper. (5) Install the needle stopper on the depth gauge. The groove of the needle stopper must attach to the notch of the depth gauge. (6) Insert the puncture needle into the V groove of the needle stopper. Needle stopper Notch Groove...
  • Page 32 MN1-1014 Rev. 14 (9) Insert the puncturing needle until the needle stopper contacts the needle locking base. The tip of the puncturing needle reaches the target puncture region. Needle locking base Needle stopper Reference point on the puncture guide line Puncture target region ―Description―...

  • Page 33: Leaving The Needle

    MN1-1014 Rev. 14 4-4. Leaving the needle The probe and the puncture adapter can be removed from the puncture needle during puncturing. (1) Turn the knob counter clockwise until stopping, and remove the puncture adapter from the probe. ② ① (2) Take the probe off the needle.

  • Page 34: Connecting To The Ultrasound Diagnostic Instrument

    MN1-1014 Rev. 14 4-6. Connecting to the ultrasound diagnostic instrument RELEASE LOCK The lock lever of the connector moves over the range shown in the figure at right. Align the ○ mark with the LOCK or RELEASE position and lock or release the electronic probe connecting socket of the diagnostic instrument ( probe connector ).

  • Page 35: Removing From The Ultrasound Diagnostic Instrument

    MN1-1014 Rev. 14 4-7. Removing from the ultrasound diagnostic instrument RELEASE LOCK The lock lever of the connector moves over the range shown in the figure at right. Align the ○ mark with the LOCK or RELEASE position and lock or release the probe connector.

  • Page 36: Precautions When Performing Puncture Operations

    MN1-1014 Rev. 14 4-8. Precautions when performing puncture operations Warning Puncturing must be performed by a skilled doctor. Improper puncturing can injure the patient. Puncturing operations must be performed by a doctor who fully understands the characteristics of ultrasound diagnostics and who is skilled and has a thorough knowledge of puncture operations under an ultrasound guide.
  • Page 37 MN1-1014 Rev. 14 Warning Do not puncture the heart region. Puncturing the heart region may cause a micro electric shock. Check that no other organs lie in the puncture path. If another organ lies in the puncture path, an unintended body part can be punctured and cause an injury to the patient.

  • Page 38: Actions To Be Taken When An Abnormal State Is Detected

    MN1-1014 Rev. 14 4-9. Actions to be taken when an abnormal state is detected 4-9-1. Ensuring safety of patients Immediately move the equipment away from the patient and quit operation. Keep the patient in safe condition and administer the required medical treatment. 4-9-2.

  • Page 39: Washing, Disinfection And Sterilization

    MN1-1014 Rev. 14 5. Washing, Disinfection and Sterilization Warning Wear protective gloves and other protective gear during washing, disinfection and sterilization. Handling of the equipment with your bare hands before disinfection or sterilization can result in an infection. After soaking in cleaning agents, thoroughly wash the equipment with running water. Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient.

  • Page 40: Washing

    MN1-1014 Rev. 14 5-1. Washing Wash the probe tip, the puncture adapter, the needle stopper and the depth gauge immediately after use with water or soak in a cleaning agent. Washing before disinfection and sterilization is very important. ○: Compatible methods Puncture adapter Puncture adapter Probe...

  • Page 41: Disinfection

    MN1-1014 Rev. 14 5-2. Disinfection Perform following disinfection as necessary. ○: Compatible methods Puncture adapter Puncture adapter Probe Needle stopper Depth gauge (Needle guide) (Knob) Liquid disinfection ○ Perform sterilization the puncture adapter or other equipment. Gas disinfection ○ 5-2-1. Chemical disinfection Applicable chemicals General name Trade name...

  • Page 42: Gas Disinfection

    MN1-1014 Rev. 14 5-2-2. Gas disinfection Applicable gases General name Trade name Manufacturer F. gen Formalin gas Aso Pharmaceutical Co., Ltd. (14% formaldehyde) Disinfection procedure Be sure to wash and fully dry the probe before disinfection. Washing See section 5-1. Disinfection the following conditions: Gas disinfection Temperature:...

  • Page 43: Sterilization

    MN1-1014 Rev. 14 5-3. Sterilization Perform following sterilization as necessary. ○: Compatible methods Puncture adapter Puncture adapter Probe Needle stopper Depth gauge (Needle guide) (Knob) EOG sterilization ○ ○ ○ ○ ○ ○ ○ Not compatible Not compatible Not compatible Liquid sterilization 5-3-1.

  • Page 44: Liquid Sterilization

    MN1-1014 Rev. 14 5-3-2. Liquid sterilization Applicable chemicals ＊ E xcept Canada General name Trade name Manufacturer TM ＊ PERASAFE Hydrogen peroxide ANTEC INTERNATIONAL Practical liquid 1.62W/V% Sterilization procedure Be sure to wash and fully dry the equipment before sterilization. Washing See section 5-1.

  • Page 45: Storage

    MN1-1014 Rev. 14 6. Storage 6-1. Actions before storing When the probe will not be used for an extended period of time, perform the procedures described in section 5 “Washing, Disinfection and Sterilization" and then store it in its storage case. Wash and sterilize the puncture adapter, the needle stopper and the depth gauge and store in sterile.
  • Page 46 MN1-1014 Rev. 14 -40-...

  • Page 47: Moving And Transporting

    MN1-1014 Rev. 14 7. Moving and Transporting 7-1. Moving and transporting In this section, moving refers to "carrying of the equipment within a facility" and transporting refers to "transferring using a vehicle or sending the probe for repairs". 7-2. Preparing the probe and accessories for moving Store in the storage case after performing the procedure in section 5 “Washing, Disinfection and Sterilization".
  • Page 48 MN1-1014 Rev. 14 -42-...

  • Page 49: Periodic Inspection

    MN1-1014 Rev. 14 8. Periodic Inspection 8-1. Safety tests of the probe The safety tests should be conducted at least once a year by a qualified technician. The test record should be stored for future reference. Remarks 1 Qualified technician: personnel for conducting safety tests of medical electrical equipment. If the user requires an appropriate qualified technician, Aloka trained service personnel can conduct a test at the user’s expense.

  • Page 50: Testing Of Measurement Tolerances

    MN1-1014 Rev. 14 8-2. Testing of measurement tolerances Perform the measurements specified below using an ultrasonic phantom* at least once per year. The test record should be stored for future reference. • Sensitivity • Resolution Remarks Make a copy of the Measurement accuracy inspection data sheet provided in the instruction manual for the ultrasound diagnostic instrument.

  • Page 51: Safety Tests Of The Puncture Adapter

    MN1-1014 Rev. 14 8-3. Safety tests of the puncture adapter Conduct a periodic safety tests at least once a year by referring to section 3-2 "Start up check of the puncture adapter" and section 3-3 "Checking the needle echo". Also conduct the safety tests for the probe that is used. Warning Be sure a safety tests at least once a year.
  • Page 52 MN1-1014 Rev. 14 -46-...

  • Page 53: Configuration

    MN1-1014 Rev. 14 9. Configuration 9-1. Standard configuration Probe UST-9113P-3.5 ..............1 set Puncture adapter MP-2480-G18 ..............1 set Needle stopper MP-2477 ................1 piece Depth gauge MP-2480-DG ..............1 piece Storage case CB-UST-1-P2 ..............1 set Instruction manual MN1-1014 ................1 copy 9-2. Option Puncture adapter The following puncture adapter is available to match the various-sized needle.
  • Page 54 MN1-1014 Rev. 14 -48-...

  • Page 55: Disposal Of The Device

    MN1-1014 Rev. 14 10. Disposal of the Device Recycle or dispose of this equipment properly in compliance with the Waste Management and Public Cleansing Law. Caution Before disposing of the equipment, take infection-prevention measures. Disposal of the equipment without taking the proper preventative measures can lead to infection. Waste Electrical and Electronic Equipment (WEEE) Directive This products is a duty of the display of WEEE marking is imposed, into the European Union (EU).
  • Page 56 MN1-1014 Rev. 14 MN1-1014 Rev. 15 22-1, Mure 6-chome, Mitaka-shi, Tokyo, 181-8622 Japan TEL: +81-422-45-6049 URL: http://www.hitachi-aloka.com Hitachi Medical Ultrasound Logistics, Zweigniederlassung der Hitachi Medical Systems Europe Holding AG Carl-Zeiss-Strasse 5, D-72555 Metzingen, Germany Distributor MN1-1014 Rev. 15 ’12.04.01 -50-...

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