Hitachi UST-5413 Instruction Manual
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Hitachi UST-5413 Instruction Manual

Electronic linear probe
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Electronic Linear Probe
UST-5413
Instruction Manual
MN1-5239 Rev.17
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-5413

  • 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 MN1-5239 Rev.17...
  • Page 3 MN1-5239 Rev.17 Introduction This is an instruction for model UST-5413, 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

    MN1-5239 Rev.17 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. Cleaning, disinfection and sterilization precautions ..............3 1-2-3. Labels ............................. 4 2. Specifications and Parts name 2-1.
  • Page 5 MN1-5239 Rev.17 5-5. Manual cleaning and disinfection ......................26 5-5-1. Manual cleaning .......................... 26 5-5-2. Manual disinfection ........................27 5-5-3. Cable and connector ........................27 5-6. Automated cleaning and disinfecting ...................... 28 5-7. Applicable cleaners and disinfectants / Suppliers List ................29 5-8.
  • Page 6 MN1-5239 Rev.17...

  • Page 7: Safety Precautions

    MN1-5239 Rev.17 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

    MN1-5239 Rev.17 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: Cleaning, Disinfection And Sterilization Precautions

    MN1-5239 Rev.17 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

    MN1-5239 Rev.17 1-2-3. Labels (1) Probe unit Label 1 Label 2 Label 3 Label 4 Label 1 Electronic linear probe mark Frequency...
  • Page 11 MN1-5239 Rev.17 Label 2 This instrument complies with Directive 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS. IPX7 IPX7 mark See section 2-2, “Specifications”. Type BF applied part Do not waste the instrument as general waste. Comply with a local regulation.
  • Page 12 MN1-5239 Rev.17 (2) Storage case Label A Label B...
  • Page 13 MN1-5239 Rev.17 Label A(Examples) Model Serial No. Manufacturer Label B(Examples) 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 14 MN1-5239 Rev.17...

  • Page 15: Specifications And Parts Name

    MN1-5239 Rev.17 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

    MN1-5239 Rev.17 2-2. Specifications Application regions: Neck, Mammary gland, general areas Form of application to patient: Surface Connectable instruments: SSD-3500, SSD-4000, ProSound 6, ProSound α 6, F37, F31 Field of view: 38mm Frequency: 4 to 11 MHz Cable length: 2.0 m Weight: 1090 g Service life:...

  • Page 17: Performance

    MN1-5239 Rev.17 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

    MN1-5239 Rev.17 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

    MN1-5239 Rev.17 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 MN1-5239 Rev.17 -14-...

  • Page 21: Usage

    MN1-5239 Rev.17 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

    MN1-5239 Rev.17 4-2. 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 probe connector. Connect the probe to the electronic probe connecting socket of the diagnostic instrument ( probe connector ) by following the procedure below.

  • Page 23: Removing From The Ultrasound Diagnostic Instrument

    MN1-5239 Rev.17 4-3. 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. Use the procedure below to remove the probe from the electronic scan probe connector of the ultrasound diagnostic instrument ( probe connector ) .

  • Page 24: Precautions When Performing Puncture Operations

    MN1-5239 Rev.17 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

    MN1-5239 Rev.17 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 MN1-5239 Rev.17 -20-...

  • Page 27: Cleaning, Disinfection And Sterilization

    Applicable cleaning, disinfection and sterilization methods for each product are listed in the Table 1. The detail of each method is described in Chapter 5-2. Table 1 Applicable cleaning, disinfection and sterilization methods Cleaning Disinfection Sterilization Model UST-5413 Note: X means “Applicable” : Automated Need waterproof cover : Liquid sterilization USA only -21-...

  • Page 28: Precautions For Cleaning, Disinfection And Sterilization

    MN1-5239 Rev.17 5-1. Precautions for cleaning, disinfection and sterilization The following warnings and cautions must be observed when cleaning, disinfecting and sterilizing the probe and accessories. Warning Wear protective gloves and other protective gear during cleaning, disinfection and sterilization. Handling of the probe with your bare hands before sterilization can result in an infection. After finishing soaking the probe in cleaning agents, thoroughly wash it with running water.

  • Page 29: Reprocessing Instruction According To Iso 17664

    MN1-5239 Rev.17 5-2. Reprocessing instruction according to ISO 17664 Take care about clean circumstances before using the probe on the next patients. If processors reprocess this equipment, refer to these instructions. Table 1 ・ The probe is delivered unsterile. Prior to the first use, reprocess the probe. ・...
  • Page 30 MN1-5239 Rev.17 Flowchart of reprocessing process of this probe is as follows: Point of use (Pre-cleaning) Containment and transportation Manual cleaning Rinsing after manual cleaning Drying Manual disinfection Rinsing after manual disinfection Drying Maintenance, inspection and testing Packaging Sterilization -24-...

  • Page 31: Point Of Use (Pre-Cleaning)

    MN1-5239 Rev.17 5-3. Point of use (Pre-cleaning) In the operating room after use of the probe Probe 1) Remove any accessories from the probe like biopsy adapters. 2) Flush patient’s blood or fluid by tap water directly after use until the surface looks visually clean. 3) Wipe the whole surface of the probe by gauze pad and remove superficial visible impurities until the surface looks visually clean.

  • Page 32: Manual Cleaning And Disinfection

    MN1-5239 Rev.17 5-5. Manual cleaning and disinfection Prepare following items before manual cleaning and disinfection. Probe 1) Detergent: ENZOL /Cidezyme (Johnson & Johnson, #2258) or another cleaning agent with approved ® ® material compatibility for this medical device. 2) Disinfectant: Cidex OPA (Johnson &...

  • Page 33: Manual Disinfection

    MN1-5239 Rev.17 5-5-2. Manual disinfection Probe 1) Before immersing the equipment, it is recommended to test the concentration of disinfectant solution before each usage. The solution Cidex OPA is ready for use and does not need to be diluted. ® Test strips to verify that the appropriate concentration of Cidex OPA is correct are available by ®...

  • Page 34: Automated Cleaning And Disinfecting

    MN1-5239 Rev.17 5-6. Automated cleaning and disinfecting Probe Warning The probe cannot withstand Automated cleaning and disinfecting. -28-...

  • Page 35: Applicable Cleaners And Disinfectants / Suppliers List

    MN1-5239 Rev.17 5-7. Applicable cleaners and disinfectants / Suppliers List The applicable chemical solutions are listed below. General name Trade name Manufacturer ® ADVANCED STERILIZATION PRODUCTS ENZOL /Cidezyme ® ® Enzyme cleaning agent A Johnson & Johnson company Practical liquid 0.8V/V% Division of Ethicon, Inc.
  • Page 36 MN1-5239 Rev.17 High-level disinfection General name Trade name Manufacturer PERASAFE Hydrogen peroxide ANTEC INTERNATIONAL Practical liquid 1.62W/V% Acecide ® Peracetic acid Saraya Co., Ltd. Solution 6% ® WAVICIDE -01 * Glutaraldehyde Medical Chemical Corporation Solution 2.65% STERANIOS * Glutaraldehyde Laboratoires ANIOS Solution 2.0% ®...

  • Page 37: Drying

    MN1-5239 Rev.17 5-8. Drying Probe 1) Wipe the probe with single use, fluff free wipe or towel for removing moisture on the surface of the equipment. 2) If using drying heater for medical equipment, the temperature limit is a maximum of 60 °C [140 °F]. Dry until no visible moisture is left.

  • Page 38: Sterilization

    MN1-5239 Rev.17 5-11. Sterilization See “Table 1. Applicable cleaning disinfection and sterilization methods” for available sterilization methods Follow the instructions of the sterilizer manufacturer regarding usage, temperature and sterilization-time etc. Handling and maximum input to chamber of sterilizer should be according to operation manual of the sterilizer.

  • Page 39: Sterrad ® Sterilization

    MN1-5239 Rev.17 5-11-2. STERRAD sterilization ® Sterile conditions of applicable sterilization methods are as follows. The applicable gas is listed below. General name Trade name Manufacturer STERRAD ® ADVANCED STERILIZATION PRODUCTS ® Hydrogen peroxide Sterilization system A Johnson & Johnson company (58% density) (STERRAD 50, 100S, 200,...

  • Page 40: Liquid Sterilization (Usa Only)

    MN1-5239 Rev.17 5-11-3. Liquid sterilization (USA only) • Applicable chemical solution for sterilization The applicable sterilants are listed below. General name Trade name Manufacturer PERASAFE ® Hydrogen peroxide ANTEC INTERNATIONAL Practical liquid 1.62W/V% Acecide ® Peracetic acid Saraya Co., Ltd. Solution 6% WAVICIDE -01 *...

  • Page 41: Actions Before Storing The Probe

    MN1-5239 Rev.17 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 “Cleaning, disinfection and sterilization" and then store it in its storage case. 6-2.
  • Page 42 MN1-5239 Rev.17 -36-...

  • Page 43: Moving And Transporting

    MN1-5239 Rev.17 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 “Cleaning, disinfection and sterilization”.
  • Page 44 MN1-5239 Rev.17 -38-...

  • Page 45: Periodic Inspection

    MN1-5239 Rev.17 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 46: Testing Of Measurement Tolerances

    MN1-5239 Rev.17 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 47: Configuration

    MN1-5239 Rev.17 9. Configuration 9-1. Standard configuration Probe UST-5413 ................1 set Storage case CB-UST5-P1 ...............1 set Instruction manual MN1-5239 ................1 copy 9-2. Options When performing puncturing, use this probe in combination with either a puncture adapter or CIVCO bracket and CIVCO probe cover or biopsy needle guide set.
  • Page 48 MN1-5239 Rev.17 -42-...

  • Page 49: Disposal Of The Device

    MN1-5239 Rev.17 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 50 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 -44- MN1-5239 Rev.17 ’17.01.11...

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