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Hitachi Aloka Medical ASU-1003 Instruction Manual

Transvaginal electronic convex sector scanner
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MN1-5008 Rev.7
MN1-5008 Rev.8
Transvaginal Electronic Convex Sector Scanner
ASU-1003
Instruction Manual
MN1-5008 Rev.8
i

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Summary of Contents for Hitachi Aloka Medical ASU-1003

  • Page 1 MN1-5008 Rev.7 MN1-5008 Rev.8 Transvaginal Electronic Convex Sector Scanner ASU-1003 Instruction Manual MN1-5008 Rev.8...
  • Page 2 MN1-5008 Rev.7...
  • Page 3 MN1-5008 Rev.7 Introduction This is an instruction for model ASU-1003, an ultrasound scanner. Read the manual carefully before using the equipment. Take special note of the items in section 1 "Safety Precautions". Keep this manual securely for future reference. The CE mark on the scanner indicates that this scanner is valid when it is connected to the ultrasound diagnostic instrument bearing the CE mark that is specified as available in section 2 of this document.

  • Page 4: Table Of Contents

    MN1-5008 Rev.7 CONTENTS 1. Safety Precautions 1-1. Intended use ........................1 1-2. Usage precautions ......................1 1-2-1. Warnings and safety information....................1-2-2. Option usage precautions ....................... 1-2-3. Washing, disinfection and sterilization precautions ............... 1-2-4. Labels ............................. 2. Specifications and Parts name 2-1. Principles of operation ....................11 2-2.
  • Page 5 MN1-5008 Rev.7 5. Washing, Disinfection and Sterilization 5-1. Washing ..........................24 ..................24 5-1-1. Insertion portion and handle ....................24 5-1-2. Cable and connector 5-2. Disinfection ........................25 ....................25 5-2-1. Chemical disinfection ......................26 5-2-2. Gas disinfection 5-3. Sterilization ........................27 5-3-1. Liquid sterilization ........................6. Storage 6-1.
  • Page 6 MN1-5008 Rev.7...

  • Page 7: Safety Precautions

    MN1-5008 Rev. 7 1. Safety Precautions 1-1. Intended use This scanner is intended for use by a doctor or other qualified operator for inserting to a human vagina and making ultrasonic observations of the uterus and 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

    MN1-5008 Rev. 7 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 scanner. 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 MN1-5008 Rev. 7 Caution 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: Option Usage Precautions

    MN1-5008 Rev. 7 1-2-2. Option usage precautions Warning Use by covering the rubber boot over the insertion portion. If the rubber boot is not used, residual pathogens on the scanner could infect the patient. Use Aloka-approved rubber boots only. Use of an item lacking biocompatibility can cause an adverse reaction by the body of the patient. Check that the rubber boot is sterilized.

  • Page 11: Washing, Disinfection And Sterilization Precautions

    MN1-5008 Rev. 7 1-2-3. Washing, disinfection and sterilization precautions Warning Wear protective gloves and other protective gear during washing, disinfection and sterilization. Handling of the scanner with bare hands before disinfection or sterilization can result in an infection. After soaking in cleaning agents, thoroughly wash the scanner with running water. Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient.

  • Page 12: Labels

    MN1-5008 Rev. 7 1-2-4. Labels (1) Scanner unit Label 1 Label 2 Label 3 Label 1 Electronic convex scanner mark Frequency...
  • Page 13 MN1-5008 Rev. 7 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 equipment as general waste. Comply with a local regulation. See section 10. Safety warning sign Biohazard See section 5.
  • Page 14 MN1-5008 Rev. 7 (2) Storage case Label A Label B...
  • Page 15 MN1-5008 Rev. 7 MN1-5008 Rev. 8 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 16 MN1-5008 Rev. 7 MN1-5008 Rev. 8 rubber boot Label for 1 piece Label for 10 pieces 10 pieces RUBBER BOOT RB‑945BP‑NS MADE IN JAPAN Non sterile Contains or presence natural rubber latex Use by Do not reuse Keep away from sunlight Lot number -10-...

  • Page 17: Specifications And Parts Name

    MN1-5008 Rev. 7 2. Specifications and Parts name 2-1. Principles of operation This scanner and the ultrasound diagnostic instrument enable image diagnosis using ultrasonic waves. These equipments operate under the principles described below. (1) When an electric pulse signal is applied from the transmitter to the transducer of the scanner, 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 18: Specifications

    MN1-5008 Rev. 7 2-2. Specifications Application regions: Obstetric and gynecological areas Form of application to patient: Transvaginal Connectable instruments: SSD-1000, SSD-3500, SSD-4000 Electronic scan field of view: 160 ° Mechanical scan field of view: 90 ° Frequency: 6.0MHz Cable length: 2.0 m Weight: 1,350 g...

  • Page 19: Performance

    MN1-5008 Rev. 7 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 Rubber boot This covers the insertion portion for preventing infection. Follow the instructions in section 4-2. The protrusion corresponds to the front mark (direction This mark indicates the way of...

  • Page 20: Environmental Conditions

    MN1-5008 Rev. 7 2-5. Environmental conditions Use and store the scanner under the following conditions. 2-5-1. Operating environmental conditions Ambient temperature: 15°C to 40°C 59°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 21: Preparations For Use

    MN1-5008 Rev. 7 3. Preparations for Use 3-1. Start up check 3-1-1. Visual check Visually check the insertion portion,handle, 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 22 MN1-5008 Rev. 7 -16-...

  • Page 23: Usage

    MN1-5008 Rev. 7 4. Usage 4-1. Operation Check that the rubber boot is mounted and insert into the vaginal cavity. 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 24: Mounting Of Rubber Boot

    MN1-5008 Rev. 7 4-2. Mounting of rubber boot Apply a suitable amount of acoustic medium to the ultrasonic irradiation area of the scanner and then cover it with the rubber boot. Remove the air bubbles or wrinkles form on the ultrasonic irradiation area of the scanner. Apply a suitable amount of acoustic medium.

  • Page 25: Removal Of Rubber Boot

    MN1-5008 Rev. 7 4-3. Removal of rubber boot Rubber boots wrapped in tissue paper and removed from the scanner. Dispose of used tissue paper and rubber boots using infection prevention procedures based on the rules of your facility. 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.

  • Page 26: Connecting To The Ultrasound Diagnostic Instrument

    MN1-5008 Rev. 7 4-4. Connecting to the ultrasound diagnostic instrument The lock lever of the connector moves over the range shown in the figure RELEASE LOCK 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 27: Removing From The Ultrasound Diagnostic Instrument

    MN1-5008 Rev. 7 4-5. Removing from the ultrasound diagnostic instrument The lock lever of the connector moves over the range shown in the figure LOCK RELEASE at right. Align the ○ mark with the LOCK or RELEASE position and lock or release the probe connector.

  • Page 28: Actions To Be Taken When An Abnormal State Is Detected

    MN1-5008 Rev. 7 4-6. Actions to be taken when an abnormal state is detected 4-6-1. Ensuring safety of patients Immediately move the scanner away from the patient and quit operation. Keep the patient in safe condition and administer the required medical treatment. 4-6-2.

  • Page 29: Washing, Disinfection And Sterilization

    MN1-5008 Rev. 7 5. Washing, Disinfection and Sterilization Warning Wear protective gloves and other protective gear during washing, disinfection and sterilization. Handling of the scanner with bare hands before disinfection or sterilization can result in an infection. After soaking in cleaning agents, thoroughly wash the scanner with running water. Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient.

  • Page 30: Washing

    MN1-5008 Rev. 7 5-1. Washing Wash the insertion portion and handle immediately after use with water or soak in a cleaning agent. Washing before disinfection and sterilization is very important. 5-1-1. Insertion portion and handle Applicable cleaning agents General name Trade name Manufacturer ®...

  • Page 31: Disinfection

    MN1-5008 Rev. 7 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 32: Gas Disinfection

    MN1-5008 Rev. 7 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 scanner before disinfection. Washing See section 5-1. Disinfection the following conditions: Gas disinfection Temperature:...

  • Page 33: Sterilization

    MN1-5008 Rev. 7 5-3. Sterilization Perform Liquid sterilization as necessary. 5-3-1. 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 scanner before sterilization. Washing See section 5-1.
  • Page 34 MN1-5008 Rev. 7 -28-...

  • Page 35: Storage

    MN1-5008 Rev. 7 6. Storage 6-1. Actions before storing the scanner When the scanner will not be used for an extended period, perform the procedures described in section 5 “Washing, Disinfection and Sterilization" and then store it in its storage case. 6-2.
  • Page 36 MN1-5008 Rev. 7 -30-...

  • Page 37: Moving And Transporting

    MN1-5008 Rev. 7 7. Moving and Transporting 7-1. Moving and transporting In this section, moving refers to "carrying of the scanner within a facility" and transporting refers to "transferring using a vehicle or sending the scanner for repairs". 7-2. Preparing the scanner for moving Store in the storage case after performing the procedure in section 5 “Washing, Disinfection and Sterilization”.
  • Page 38 MN1-5008 Rev. 7 -32-...

  • Page 39: Periodic Inspection

    MN1-5008 Rev. 7 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 requires an appropriate qualified technician, Aloka trained service personnel can conduct a test at the user’s expense.

  • Page 40: Testing Of Measurement Tolerances

    MN1-5008 Rev. 7 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

    MN1-5008 Rev. 7 9. Configuration 9-1. Standard configuration Scanner ASU-1003 ................1 set Storage case CB-UST1-P7 ...............1 set Instruction manual MN1-5008 ................1 copy 9-2. Options • Rubber boot RB-945BP-NS (unsterilized) -35-...
  • Page 42 MN1-5008 Rev. 7 -36-...

  • Page 43: Disposal Of The Device

    MN1-5008 Rev. 7 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 MN1-5008 Rev. 7 MN1-5008 Rev. 8 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 MN1-5008 Rev. 8 ’12.04.01 -38-...

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