Hitachi UST-678 Instruction Manual
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Hitachi UST-678 Instruction Manual

Transrectum composite probe
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MN1-5255 Rev.15
Transrectum Composite Probe
UST-678
Instruction Manual
MN1-5255 Rev.15
Notes for operators and responsible maintenance personnel
★ Please read through this Instruction Manual carefully prior to use.
★ Keep this Instruction Manual together with the ultrasound diagnostic instru-
ment for any future reference.
© Hitachi, Ltd. 2013, 2017. All rights reserved.
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Summary of Contents for Hitachi UST-678

  • Page 1 Notes for operators and responsible maintenance personnel ★ Please read through this Instruction Manual carefully prior to use. ★ Keep this Instruction Manual together with the ultrasound diagnostic instru- ment for any future reference. © Hitachi, Ltd. 2013, 2017. All rights reserved.
  • Page 2 MN1-5255 Rev.15...
  • Page 3 MN1-5255 Rev.15 Introduction This is an instruction for model UST-678, 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

    MN1-5255 Rev.15 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 MN1-5255 Rev.15 5. Washing, Disinfection and Sterilization 5-1. Washing ..........................30 ..................30 5-1-1. Insertion portion and handle ....................30 5-1-2. Cable and connector 5-2. Disinfection ........................31 ....................31 5-2-1. Chemical disinfection ......................32 5-2-2. Gas disinfection 5-3. Sterilization ........................33 ................33 5-3-1. Ethylene oxide gas (EOG) sterilization .....................34 ®...
  • Page 6 MN1-5255 Rev.15...

  • Page 7: Safety Precautions

    MN1-5255 Rev. 15 1. Safety Precautions 1-1. Intended use This probe is intended for use by a doctor or other qualified operator for inserting to a human rectum and making ultrasonic observations of the prostate 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

    MN1-5255 Rev. 15 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 MN1-5255 Rev. 15 Do not use this equipment with other equipment except for those specifically approved in the manual. Use with unapproved equipment can result in an electric shock, burn, or other injury to the patient or operator and damage to this equipment and the other equipment. Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output.

  • Page 10: Option Usage Precautions

    Use by covering the balloon over the insertion portion. If the balloon is not used, residual pathogens on the probe could infect the patient. Use Hitachi-approved balloons only. Use of an item lacking biocompatibility can cause an adverse reaction by the body of the patient.

  • Page 11: Washing, Disinfection And Sterilization Precautions

    MN1-5255 Rev. 15 1-2-3. Washing, disinfection and sterilization precautions 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 12: Labels

    MN1-5255 Rev. 15 1-2-4. Labels (1) Probe unit Label 2 Label 1 Label 3 Label 4 Label 1 Electronic convex probe mark Frequency Label 2 Electronic linear probe mark Frequency...
  • Page 13 MN1-5255 Rev. 15 Label 3 This instrument complies with Directive 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS. 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.
  • Page 14 MN1-5255 Rev. 15 (2) Storage case Label B Label A Label D Label C...
  • Page 15 MN1-5255 Rev. 15 Label A Model Serial No. Label B Label C Hitachi Medical Systems GmbH Otto-von-Guericke-Ring 3 D-65205 Wiesbaden, Germany 2016-09 P-3258F This instrument complies with Directive 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS. DATE OF MANUFACTURE...
  • Page 16 MADE IN JAPAN Label for 10 pieces 10 pieces Rx Only BALLOON BL-664-NS MADE IN JAPAN Hitachi Medical Systems GmbH Otto-von-Guericke-Ring 3 D-65205 Wiesbaden, Germany Non sterile Contains or presence natural rubber latex Use by Do not reuse Keep away from sunlight...

  • Page 17: Specifications And Parts Name

    MN1-5255 Rev. 15 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 18: Specifications

    MN1-5255 Rev. 15 2-2. Specifications Application regions: Urological applications Form of application to patient: Transrectum Connectable instruments: SSD-α10, Prosound α7, Prosound F75 Field of view: Vertical to Axis (Convex) : 120° Parallel to Axis (Linear) : 60mm Frequency: Vertical to Axis (Convex) : 3.0 to 9.0MHz Parallel to Axis (Linear) : 4.0 to 10.0MHz...

  • Page 19: Performance

    MN1-5255 Rev. 15 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 Inlet/drain nipple Scale marks Cable Follow the directions specified The scale marks indicate insertion This cable propagates the transmitting in section 4-2.
  • Page 20 MN1-5255 Rev. 15 ・ Balloon Cover the insertion portion with this balloon to prevent infection. Follow the instructions in section 4-2. Rubber band ・ Rubber band This is used to keep water in the balloon. Inlet/drain port nipple ・ Syringe ・...

  • Page 21: Environmental Conditions

    MN1-5255 Rev. 15 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 22 MN1-5255 Rev. 15 -16-...

  • Page 23: Preparations For Use

    MN1-5255 Rev. 15 3. Preparations for Use 3-1. Start up check 3-1-1. Visual check Visually check the ultrasonic irradiation area, insertion portion, handle, cable, connector and balloon. If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are found, do not use the equipment. 3-1-2.
  • Page 24 MN1-5255 Rev. 15 -18-...

  • Page 25: Usage

    MN1-5255 Rev. 15 4. Usage 4-1. Operation Check that the balloon is mounted and insert to the rectum. An image of the region of interest is displayed on the monitor of the ultrasound diagnostic instrument. Furthermore, this probe enables observation of two sections which cross each other at right angles: a horizontal section and a vertical section.

  • Page 26: Mounting Of Balloon

    Use by covering the balloon over the insertion portion. If the balloon is not used, residual pathogens on the probe could infect the patient. Use Hitachi-approved balloons only. Use of an item lacking biocompatibility can cause an adverse reaction by the body of the patient.
  • Page 27 MN1-5255 Rev. 15 ① Connect one end of the extension tube to the inlet/drain nipple of the probe, and connect the other end of the tube to the three-way cocks. Either of the three-way cocks may be connected. ② Insert the probe into the balloon. Balloon ③...

  • Page 28: Insertion Of The Probe

    MN1-5255 Rev. 15 4-3. Insertion of the probe ① Return deaerated water to the syringe until the balloon becomes deflated, with only a small amount of water remaining in it. Then, insert the probe into the rectum. A small amount of water remains in the balloon ②...

  • Page 29: Removal Of Balloon

    MN1-5255 Rev. 15 4-4. Removal of balloon ① Turn the flare of the balloon inside out, as illustrated right. Flare of the balloon ② Rubber boots wrapped in tissue paper and removed from the probe. ③ Dispose of used tissue paper, rubber boots and a rubber band using infection prevention procedures based on the rules of your facility.

  • Page 30: Connecting To The Ultrasound Diagnostic Instrument

    MN1-5255 Rev. 15 4-5. Connecting to the ultrasound diagnostic instrument 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 31: Removing From The Ultrasound Diagnostic Instrument

    MN1-5255 Rev. 15 4-6. Removing from the ultrasound diagnostic instrument 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 32: Precautions When Performing Puncture Operations

    MN1-5255 Rev. 15 4-7. 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 33: Actions To Be Taken When An Abnormal State Is Detected

    MN1-5255 Rev. 15 4-8. Actions to be taken when an abnormal state is detected 4-8-1. 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. 4-8-2.
  • Page 34 MN1-5255 Rev. 15 -28-...

  • Page 35: Washing, Disinfection And Sterilization

    MN1-5255 Rev. 15 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 36: Washing

    MN1-5255 Rev. 15 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 37: Disinfection

    MN1-5255 Rev. 15 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 38: Gas Disinfection

    MN1-5255 Rev. 15 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 39: Sterilization

    MN1-5255 Rev. 15 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 40: Sterrad Sterilization

    MN1-5255 Rev. 15 ® 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 41: Liquid Sterilization

    MN1-5255 Rev. 15 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 42 MN1-5255 Rev. 15 -36-...

  • Page 43: Storage

    MN1-5255 Rev. 15 6. Storage 6-1. Actions before storing the probe When the equipment 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 44 MN1-5255 Rev. 15 -38-...

  • Page 45: Moving And Transporting

    MN1-5255 Rev. 15 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 46 MN1-5255 Rev. 15 -40-...

  • Page 47: Periodic Inspection

    MN1-5255 Rev. 15 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, service personnel trained by us can conduct a test at the user’s expense.

  • Page 48: Testing Of Measurement Tolerances

    MN1-5255 Rev. 15 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 49: Configuration

    MN1-5255 Rev. 15 9. Configuration 9-1. Standard configuration Probe UST-678 1 set Rubber band FS 5/16" 50 pieces Syringe SS-50LZ 1 piece Three-way cock TS-TL2K 1 piece Extension tube SF-ET3825L 1 piece Surgical tape #1525 1/2" 3 rolls Purse locks...
  • Page 50 MN1-5255 Rev. 15 -44-...

  • Page 51: Disposal Of The Device

    MN1-5255 Rev. 15 10. Disposal of the Device Recycle or dispose this equipment properly in compliance with the Waste Management and Public Cleansing Law. Caution Before disposing 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 The illustration on the right is required by the EU WEEE Directive to appear on all electrical and electronic equipment.
  • Page 52 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 Distributor -46- MN1-5255 Rev.15 ’17.01.11...

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