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Hitachi UST-5417 Instruction Manual

Electronic linear probe
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MN1-5752
Rev.8
Electronic Linear Probe
UST-5417
Instruction Manual
MN1-5752 Rev.8
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.
-i-
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Summary of Contents for Hitachi UST-5417

  • 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 MN1-5752 Rev.8 -ii-...
  • Page 3 MN1-5752 Rev.8 Introduction This is an instruction for model UST-5417, an ultrasound probe. 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 probe indicates that this probe is valid when it is connected to ultrasound diagnostic instrument bearing the CE mark that is specified as available in section 2 of this document.

  • Page 4: Table Of Contents

    MN1-5752 Rev.8 CONTENTS 1. Safety Precautions ..........................1 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 ............4 1-2-3. Labels ..........................5 1-2-4. Option (Elasto coupler) Labels ..................... 9 2. Specifications and Parts name .....................11 2-1.
  • Page 5 MN1-5752 Rev.8 5-2. Reprocessing instruction according to ISO 17664 ..............29 5-3. Point of use (Pre-cleaning) ......................31 5-4. Containment and transportation ....................31 5-5. Manual cleaning and disinfection ....................32 5-5-1. Manual cleaning ......................33 5-5-2. Manual disinfection .......................34 5-5-3. Cable and connector .......................35 5-6.
  • Page 6 MN1-5752 Rev.8...

  • Page 7: Safety Precautions

    MN1-5752 Rev.8 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

    MN1-5752 Rev.8 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 MN1-5752 Rev.8 Caution Constantly check for anything abnormal about the patient’s condition and the 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: Cleaning, Disinfection And Sterilization Precautions

    MN1-5752 Rev.8 1-2-2. Cleaning, disinfection and sterilization precautions Warning Wear protective gloves and other protective gear during cleaning, disinfection and sterilization. Handling of the probe with 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 11: Labels

    MN1-5752 Rev.8 1-2-3. Labels (1) Probe unit Label 1 Label 2 Label 3 Electronic linear probe mark Label 1 Frequency...
  • Page 12 MN1-5752 Rev.8 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 equipment as general waste. Comply with a local regulation. See section 10.
  • Page 13 MN1-5752 Rev.8 (2) Storage case Label A Label B...
  • Page 14 MN1-5752 Rev.8 Label A Model (Examples) Serial No. 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 15: Option (Elasto Coupler) Labels

    MN1-5752 Rev.8 1-2-4. Option (Elasto coupler) Labels Label B Label C Label A...
  • Page 16 See section 5. Safety warning sign Follow the instruction manual to operate this instrument. If not avoided, may result in injury, property damage, or the equipment trouble Label C Hitachi Medical Systems GmbH Otto-von-Guericke-Ring 3 D-65205 (Examples) Wiesbaden, Germany 2016-09 P-3258F...

  • Page 17: Specifications And Parts Name

    MN1-5752 Rev.8 2. Specifications and Parts name 2-1. Principles of operation This probe 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 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

    MN1-5752 Rev.8 2-2. Specifications 2-2-1. Specifications of the probe Application regions: Mammary gland, Superficial organs Form of application to patient: Surface ProSound α7, ProSound F75, F37 Connectable instruments: Field of view: 38mm Frequency: 4 to 14MHz Cable length: 2.1 m Weight: 940 g Service life:...

  • Page 19: Specifications Of The Elasto Coupler

    MN1-5752 Rev.8 2-2-2. Specifications of the Elasto coupler* * This equipment is the option of this probe. Model Name: MP-2809 Material: Polyphenylene oxide Service life: Three years Weight: External dimensions As shown in the figure below. Unit: mm Remarks The dimensions are within ±10% of the indicated values. -13-...

  • Page 20: Performance

    MN1-5752 Rev.8 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 signals This area is held during operation. that are sent and received.

  • Page 21: Environmental Conditions

    MN1-5752 Rev.8 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 MN1-5752 Rev.8 -16-...

  • Page 23: Preparations For Use

    MN1-5752 Rev.8 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. The same check should be done with the Elasto coupler.
  • Page 24 MN1-5752 Rev.8 -18-...

  • Page 25: Usage

    MN1-5752 Rev.8 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 26: Attaching Of The Elasto Coupler

    MN1-5752 Rev.8 4-2. Attaching of the Elasto coupler Attach the Elasto coupler to the probe as shown in the figure below. Mount the Elasto coupler on the protrusions on the side of the probe and make sure that it is firmly attached to the probe.

  • Page 27: Removal Of The Elasto Coupler

    MN1-5752 Rev.8 4-3. Removal of the Elasto coupler 4-3-1. Removing from the probe The Elasto coupler is removed as shown in the figure below. protrusions on the side. (1) Press one end of the Elasto coupler to remove it from the probe (2) Remove the other end of the Elasto coupler in the same way to free it from the probe.

  • Page 28: Connecting To The Ultrasound Diagnostic Instrument

    MN1-5752 Rev.8 4-4. 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 29: Removing From The Ultrasound Diagnostic Instrument

    MN1-5752 Rev.8 4-5. 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 probe connector.

  • Page 30: Puncturing Precautions

    MN1-5752 Rev.8 4-6. Puncturing precautions Warning Carefully read the usage precautions in the documentation supplied with the needle guide bracket. 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. Puncturing operations must be performed by a doctor who fully understands the characteristics of ultrasonic diagnostics and who is skilled and has a thorough knowledge of puncture operations under an ultrasonic guide.

  • Page 31: Actions To Be Taken When An Abnormal State Is Detected

    MN1-5752 Rev.8 Warning Check beforehand any areas not displayed on the ultrasound image that are along the puncturing path. If other tissues are in the area not displayed on the ultrasound image, there is a risk of puncturing an unintended body part and causing an injury to the patient. When performing puncturing, use a needle guide bracket that is described in the documentation.
  • Page 32 MN1-5752 Rev.8 -26-...

  • Page 33: 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-5417 MP-2809 Note: X means “Applicable” : Automated Need waterproof cover : Liquid sterilization USA only -27-...

  • Page 34: Precautions For Cleaning, Disinfection And Sterilization

    MN1-5752 Rev.8 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 35: Reprocessing Instruction According To Iso 17664

    MN1-5752 Rev.8 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 36 MN1-5752 Rev.8 Flowchart of reprocessing process of this probe and accessories is as follows: Point of use (Pre-cleaning) Containment and transportation Manual cleaning and disinfection Washer disinfector (WD) Manual cleaning Rinsing after manual cleaning Automated cleaning Drying Automated disinfection Manual disinfection Rinsing after manual disinfection Drying Maintenance, inspection and testing...

  • Page 37: Point Of Use (Pre-Cleaning)

    MN1-5752 Rev.8 5-3. Point of use (Pre-cleaning) In the operating room after use of the probe A) Probe 1) Remove any accessories from the probe like biopsy adapters or the elasto coupler. 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 B).

  • Page 38: Manual Cleaning And Disinfection

    MN1-5752 Rev.8 5-5. Manual cleaning and disinfection Prepare following items before manual cleaning and disinfection. A) 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 39: Manual Cleaning

    MN1-5752 Rev.8 5-5-1. Manual cleaning A) Probe 1) The temperature of the detergent solution should be between 15-30 °C [59-86 °F], concentration is 1.6%. Please note the minimum contact time of the detergent in the manufacturer’s instruction. If a differing detergent is used, please also consider the approved material compatibility for this probe.

  • Page 40: Manual Disinfection

    MN1-5752 Rev.8 5-5-2. Manual disinfection A) 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. ®...

  • Page 41: Cable And Connector

    MN1-5752 Rev.8 5-5-3. Cable and connector Wipe the cable in 20 cm intervals with gauze dipped in ethyl alcohol or water, and dry it after wiping. Clean the connector with gauze dipped in ethyl alcohol, and dry it after cleaning. Clean the other parts of the probe which must not be soaked in liquid in the same manner as the connector.

  • Page 42: Applicable Cleaners And Disinfectants / Suppliers List

    MN1-5752 Rev.8 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 43 MN1-5752 Rev.8 High-level disinfection General name Trade name Manufacturer STERANIOS * Glutaraldehyde Laboratoires ANIOS Solution 2.0% ® ADVANCED STERILIZATION PRODUCTS Cidex plus ® Glutaral A Johnson & Johnson company Solution 3.4% Division of Ethicon, Inc. Note: * indicates that the marked disinfectant is not applicable in Canada. Warning After disinfection, thoroughly rinse the probe with deionized water.

  • Page 44: Drying

    MN1-5752 Rev.8 5-8. Drying A) 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 45: Sterilization

    MN1-5752 Rev.8 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 46: Sterrad ® Sterilization

    MN1-5752 Rev.8 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 47: Liquid Sterilization (Usa Only)

    MN1-5752 Rev.8 5-11-3. Liquid sterilization (USA only) • Applicable chemical solution for sterilization The applicable sterilants are listed below. General name Trade name Manufacturer STERANIOS * Glutaraldehyde Laboratoires ANIOS Solution 2.0% ® ADVANCED STERILIZATION PRODUCTS Cidex plus ® Glutaral A Johnson & Johnson company Solution 3.4% Division of Ethicon, Inc.
  • Page 48 MN1-5752 Rev.8 -42-...

  • Page 49: Storage

    MN1-5752 Rev.8 6. Storage 6-1. Actions before storing the probe When the probe will not be used for an extended period, perform the procedures described in section 5 “Cleaning, disinfection and sterilization" and then store it in its storage case. 6-2.
  • Page 50 MN1-5752 Rev.8 -44-...

  • Page 51: Moving And Transporting

    MN1-5752 Rev.8 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 for moving Store in the storage case after performing the procedure in section 5 “Cleaning, disinfection and sterilization".
  • Page 52 MN1-5752 Rev.8 -46-...

  • Page 53: Periodic Inspection

    MN1-5752 Rev.8 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, service personnel trained by us can conduct a test at the user’s expense.

  • Page 54: Testing Of Measurement Tolerances

    MN1-5752 Rev.8 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 55: Configuration

    MN1-5752 Rev.8 9. Configuration 9-1. Standard configuration Probe UST-5417 ................1 set Storage case CB-UST1-P1 ...............1 set Instruction manual MN1-5752 ................1 copy 9-2. Options Elasto coupler MP-2809 This coupler is attached to the probe to evenly distribute body surface pressure when the probe displays images using real-time tissue elastography.
  • Page 56 MN1-5752 Rev.8 -50-...

  • Page 57: Disposal Of The Device

    MN1-5752 Rev.8 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 58 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 -52- MN1-5752 Rev. 8 ’17.03.03...

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