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Hitachi Aloka Medical UST-5546 Instruction Manual

Electronic linear probe
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MN1-5018 Rev.13
MN1-5018 Rev.15
Electronic Linear Probe
UST-5546
Instruction Manual
MN1-5018 Rev.15
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Summary of Contents for Hitachi Aloka Medical UST-5546

  • Page 1 MN1-5018 Rev.13 MN1-5018 Rev.15 Electronic Linear Probe UST-5546 Instruction Manual MN1-5018 Rev.15...
  • Page 2 MN1-5018 Rev.13...
  • Page 3 MN1-5018 Rev.13 Introduction This is an instruction for model UST-5546, 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

    MN1-5018 Rev.13 CONTENTS 1. Safety Precautions 1-1. Intended use ........................1 1-2. Usage precautions ......................1 ..................2 1-2-1. Warnings and safety information ............3 1-2-2. Washing, disinfection and sterilization precautions ........................4 1-2-3. Labels 2. Specifications and Parts name 2-1. Principles of operation ......................9 2-2.
  • Page 5 MN1-5018 Rev.13 5. Washing, Disinfection and Sterilization 5-1. Washing ..........................22 .........................22 5-1-1. Probe tip ....................22 5-1-2. Cable and connector 5-2. Disinfection ........................23 ....................23 5-2-1. Chemical disinfection ......................24 5-2-2. Gas disinfection 5-3. Sterilization ........................25 ................25 5-3-1. Ethylene oxide gas (EOG) sterilization .....................26 ®...
  • Page 6 MN1-5018 Rev.13...

  • Page 7: Safety Precautions

    MN1-5018 Rev. 13 1. Safety Precautions 1-1. Intended use This probe is intended for use by a doctor or other qualified operator when placed into direct contact with the skin making ultrasonic observations of surrounding organs. Caution Do not use this equipment for other than its intended purpose. Use for other purposes can cause burns or other injuries to the patient or operator.

  • Page 8: Warnings And Safety Information

    MN1-5018 Rev. 13 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: Washing, Disinfection And Sterilization Precautions

    MN1-5018 Rev. 13 Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output. Overuse can adversely affect the internal tissues of the patient. For details about the acoustic output, please refer to the documentation supplied with the ultrasound diagnostic instrument.

  • Page 10: Labels

    MN1-5018 Rev. 13 MN1-5018 Rev. 14 1-2-3. Labels (1) Probe unit Label 1 Label 2 Label 3 Label 1 Electronic linear probe mark Frequency...
  • Page 11 MN1-5018 Rev. 13 MN1-5018 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.
  • Page 12 MN1-5018 Rev. 13 (2) Storage case Label A Label B...
  • Page 13 MN1-5018 Rev. 13 MN1-5018 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...
  • Page 14 MN1-5018 Rev. 13...

  • Page 15: Specifications And Parts Name

    MN1-5018 Rev. 13 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 16: Specifications

    MN1-5018 Rev. 13 2-2. Specifications Application regions: Neck, general areas Form of application to patient: Surface Connectable instruments: SSD-3500,SSD-4000 Field of view: 38 mm Frequency: 8.5MHz Cable length: 2.0 m Weight: 900 g Service life: Three years Range of applied part Ultrasonic irradiation area, see the section 2-4.

  • Page 17: Performance

    MN1-5018 Rev. 13 2-3. Performance For measurement tolerances, operating tolerances and other data, refer to the instruction manual for the ultrasound diagnostic instrument. 2-4. Name of each parts Probe tip Cable This area is held during operation. This cable propagates the ultrasonic signals that are sent and received.

  • Page 18: Environmental Conditions

    MN1-5018 Rev. 13 2-5. Environmental conditions Use and store the probe 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 19: Preparations For Use

    MN1-5018 Rev. 13 3. Preparations for Use 3-1. Start up check 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 20 MN1-5018 Rev. 13 -14-...

  • Page 21: Usage

    MN1-5018 Rev. 13 4. Usage 4-1. Operation Bring the ultrasonic irradiation area of the probe into 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 22: Connecting To The Ultrasound Diagnostic Instrument

    MN1-5018 Rev. 13 4-2. Connecting to the ultrasound diagnostic instrument The lock lever of the connector moves over the range shown in the figure at right. RELEASE LOCK Align the ○ mark with the LOCK or RELEASE position and lock or release the probe connector.

  • Page 23: Removing From The Ultrasound Diagnostic Instrument

    MN1-5018 Rev. 13 4-3. Removing from the ultrasound diagnostic instrument The lock lever of the connector moves over the range shown in the figure at right. RELEASE LOCK Align the ○ mark with the LOCK or RELEASE position and lock or release the probe connector.

  • Page 24: Precautions When Performing Puncture Operations

    MN1-5018 Rev. 13 4-4. Precautions when performing puncture operations Warning Carefully read the usage precautions in the documentation supplied with the puncture adapter. Be sure that the preparations for use are completed before using. Puncturing must be performed by a skilled doctor. Improper puncturing can injure the patient.

  • Page 25: Actions To Be Taken When An Abnormal State Is Detected

    MN1-5018 Rev. 13 Warning Before using a needle cannula with the puncture adapter as a guide, first check that the cannula moves smoothly through the tube without causing any damage on the surface of the cannula and then operate with caution. If the cannula does not move smoothly or is forced to bend when inserted in or pulled out of the puncture adapter, it may damage the insulation membrane covering the cannula and may cause burns to the tissue exposed to the damaged area of the cannula.
  • Page 26 MN1-5018 Rev. 13 -20-...

  • Page 27: Washing, Disinfection And Sterilization

    MN1-5018 Rev. 13 5. Washing, Disinfection and Sterilization Warning Wear protective gloves and other protective gear during washing, disinfection and sterilization. Handling of the probe with your bare hands before disinfection or sterilization can result in an infection. After soaking in cleaning agents, thoroughly wash the probe with running water. Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient.

  • Page 28: Washing

    MN1-5018 Rev. 13 5-1. Washing Wash the probe tip immediately after use with water or soak in a cleaning agent. Washing before disinfection and sterilization is very important. 5-1-1. Probe tip Applicable cleaning agents General name Trade name Manufacturer ® ADVANCED STERILIZATION PRODUCTS ENZOL™...

  • Page 29: Disinfection

    MN1-5018 Rev. 13 5-2. Disinfection Either chemical disinfection or gas disinfection is performed as necessary. 5-2-1. Chemical disinfection Applicable chemicals General name Trade name Manufacturer CIDEX™ Glutaral ® ADVANCED STERILIZATION PRODUCTS Solution 2.4% A Johnson & Johnson company CIDEX OPA™ Ortho-phthalaldehyde Division of Ethicon, Inc.

  • Page 30: Gas Disinfection

    MN1-5018 Rev. 13 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 31: Sterilization

    MN1-5018 Rev. 13 5-3. Sterilization Perform Ethylene oxide gas (EOG) sterilization, STERRAD sterilization or Liquid sterilization as necessary. 5-3-1. Ethylene oxide gas (EOG) sterilization Applicable gases General name Trade name Manufacturer AMPROLENE Ethylene oxide gas Central Uni Co., LTD. 84% density Sterilization procedure Be sure to wash and fully dry the probe before sterilization.

  • Page 32: Sterrad Sterilization

    MN1-5018 Rev. 13 ® 5-3-2. STERRAD sterilization Applicable gases General name Trade name Manufacturer ® ADVANCED STERILIZATION PRODUCTS Hydrogen peroxide STERRAD A Johnson & Johnson company (58% density) Sterilization system Division of Ethicon, Inc. Sterilization procedure Be sure to wash and fully dry the probe before sterilization. Washing See section 5-1.

  • Page 33: Liquid Sterilization

    MN1-5018 Rev. 13 5-3-3. Liquid sterilization Applicable chemicals ＊ Except 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 probe before sterilization. Washing See section 5-1.
  • Page 34 MN1-5018 Rev. 13 -28-...

  • Page 35: Storage

    MN1-5018 Rev. 13 6. Storage 6-1. Actions before storing the probe 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. 6-2.
  • Page 36 MN1-5018 Rev. 13 -30-...

  • Page 37: Moving And Transporting

    MN1-5018 Rev. 13 7. Moving and Transporting 7-1. Moving and transporting In this section, moving refers to "carrying of the probe 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 38 MN1-5018 Rev. 13 -32-...

  • Page 39: Periodic Inspection

    MN1-5018 Rev. 13 8. Periodic Inspection 8-1. Safety tests 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 require an appropriate qualified technician, Aloka trained service personnel can conduct a test at the user’s expense.

  • Page 40: Testing Of Measurement Tolerances

    MN1-5018 Rev. 13 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 41: Configuration

    MN1-5018 Rev. 13 9. Configuration 9-1. Standard configuration Probe UST-5546 ................1 set Storage case CB-UST1-P1 ...............1 set Instruction manual MN1-5018 ................1 copy 9-2. Options When performing puncturing, use this probe in combination with CIVCO bracket and CIVCO probe cover or biopsy needle guide set.
  • Page 42 MN1-5018 Rev. 13 -36-...

  • Page 43: Disposal Of The Device

    MN1-5018 Rev. 13 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, disinfect or take other 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 44 MN1-5018 Rev. 13 MN1-5018 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 MN1-5018 Rev. 15 ’12.04.01 -38-...

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