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Hitachi UST-547 Instruction Manual

Intraoperative electronic linear probe

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Intraoperative Electronic Linear Probe
UST-547
Instruction Manual
MN1-5053 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, 2016. All rights reserved.
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Summary of Contents for Hitachi UST-547

  • 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, 2016. All rights reserved.
  • Page 2 MN1-5053 Rev.15...
  • Page 3 MN1-5053 Rev.15 Introduction This is an instruction for model UST-547, 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

    MN1-5053 Rev.15 CONTENTS 1. Safety Precautions 1-1. Intended use ........................1 1-2. Usage precautions ......................1 ..................2 1-2-1. Warnings and safety information 1-2-2. Precautions when using the probe in neurosurgery applications .......................5 1-2-3. Cleaning, disinfection and sterilization precautions ........................6 1-2-4. Labels 2.
  • Page 5 MN1-5053 Rev.15 5. Cleaning, disinfection and sterilization 5-1. Precautions for cleaning, disinfection and sterilization ..........26 5-2. Reprocessing instruction according to ISO 17664 ............27 5-3. Point of use (Pre-cleaning) .....................29 5-4. Containment and transportation ..................29 5-5. Manual cleaning and disinfection ...................30 ......................30 5-5-1.
  • Page 6 MN1-5053 Rev.15...
  • Page 7: Safety Precautions

    MN1-5053 Rev. 15 1. Safety Precautions 1-1. Intended use This probe is intended for use by a doctor when placed to direct contact with human internal organs during surgery making ultrasonic observations. With the exception of Japan, you can use the probe in neurosurgery applications if you attach our recommended transducer cover to the probe.
  • Page 8: Warnings And Safety Information

    MN1-5053 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 MN1-5053 Rev. 15 Caution Constantly check for anything abnormal about the patient’s condition and probe. 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 probe away from the patient and stop use of the probe.
  • Page 10: Precautions When Using The Probe In Neurosurgery Applications

    MN1-5053 Rev. 15 1-2-2. Precautions when using the probe in neurosurgery applications Warning When using this probe in neurosurgery applications, attach our recommended transducer cover to the probe. Failure to properly use the transducer cover may cause harm to the patient. Use our recommended transducer cover.
  • Page 11: Cleaning, Disinfection And Sterilization Precautions

    MN1-5053 Rev. 15 1-2-3. Cleaning, disinfection and sterilization precautions 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 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

    MN1-5053 Rev. 15 1-2-4 Labels (1) Probe unit Label 1 Label 2 Label 3 Label 1 Electronic linear probe mark Frequency...
  • Page 13 MN1-5053 Rev. 15 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 14 MN1-5053 Rev. 15 (2) Storage case Label A Label B...
  • Page 15 MN1-5053 Rev. 15 Label A Model Serial No. Label B 2016 This instrument complies with Directive 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS. DATE OF MANUFACTURE (in case of 2016) 2016 MANUFACTURER...
  • Page 16 MN1-5053 Rev. 15 -10-...
  • Page 17: Specifications And Parts Name

    MN1-5053 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

    MN1-5053 Rev. 15 2-2. Specifications 2-2-1. Specifications of the probe Application regions: Intraoperative diagnosis With the exception of Japan neurosurgery applications are possible if our recommended transducer cover is attached to our probe. Form of application to patient: Intraoperative With the exception of Japan neurosurgery applications are possible if our recommended transducer cover is attached to our probe.
  • Page 19: Transducer Cover When Using The Probe In Neurosurgery Application

    2-2-2.Transducer cover when using the probe in neurosurgery application CIVCO Transducer cover 610-1107 , 610-1107-EU This transducer cover can be used in neurosurgery applications and it is Pyrogen free. If you are unable to obtain the transducer cover locally, please contact your local Hitachi Medical Systems representative. -13-...
  • Page 20: Performance

    MN1-5053 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. 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

    MN1-5053 Rev. 15 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 22 MN1-5053 Rev. 15 -16-...
  • Page 23: Preparations For Use

    MN1-5053 Rev. 15 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 24 MN1-5053 Rev. 15 -18-...
  • Page 25: Usage

    MN1-5053 Rev. 15 4. Usage 4-1. Operation During surgery, the probe is in direct contact with the inner organs. 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: Connecting To The Ultrasound Diagnostic Instrument

    MN1-5053 Rev. 15 4-2. Connecting to the ultrasound diagnostic instrument RELEASE LOCK 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 27: Removing From The Ultrasound Diagnostic Instrument

    MN1-5053 Rev. 15 4-3. Removing from the ultrasound diagnostic instrument The lock lever of the connector moves over the range shown in the figure at RELEASE LOCK right. Align the ○ mark with the LOCK or RELEASE position and lock or release the probe connector.
  • Page 28: When Using The Probe For Neurosurgery Applications

    MN1-5053 Rev. 15 4-4. When using the probe for neurosurgery applications When using the probe in neurosurgery applications, please attach our recommended transducer cover to our sterilized probe. 4-4-1. How to attach the transducer cover Apply some sterilized echo jelly which is attached to our recommended transducer cover to the ultra- sound scanning surface of the sterilized probe.
  • Page 29: Precautions When Using The Probe In Neurosurgery Applications

    MN1-5053 Rev. 15 4-5. Precautions when using the probe in neurosurgery applications Warning When using this probe in neurosurgery applications, attach our recommended transducer cover to the probe. Failure to properly use the transducer cover may cause harm to the patient. Use our recommended transducer cover.
  • Page 30: Actions To Be Taken When An Abnormal State Is Detected

    MN1-5053 Rev. 15 4-6. Actions to be taken when an abnormal state is detected 4-6-1. Ensuring safety of patients Immediately move the probe away from the patient and quit operation. Keep the patient in safe condition and administer the required medical treatment. 4-6-2.
  • Page 31: 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-547 Note: X means “Applicable” : Automated Need waterproof cover : Liquid sterilization USA only -25-...
  • Page 32: Precautions For Cleaning, Disinfection And Sterilization

    MN1-5053 Rev. 15 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.
  • Page 33: Reprocessing Instruction According To Iso 17664

    MN1-5053 Rev. 15 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 34 MN1-5053 Rev. 15 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 -28-...
  • Page 35: Point Of Use (Pre-Cleaning)

    MN1-5053 Rev. 15 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 and transducer covers.. 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 36: Manual Cleaning And Disinfection

    MN1-5053 Rev. 15 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 37: Manual Disinfection

    MN1-5053 Rev. 15 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. ®...
  • Page 38: Automated Cleaning And Disinfecting

    MN1-5053 Rev. 15 5-6. Automated cleaning and disinfecting Probe Warning The probe cannot withstand Automated cleaning and disinfecting. -32-...
  • Page 39: Applicable Cleaners And Disinfectants / Suppliers List

    MN1-5053 Rev. 15 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 40 MN1-5053 Rev. 15 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 41: Drying

    MN1-5053 Rev. 15 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 42: Sterilization

    MN1-5053 Rev. 15 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 43: Sterrad ® Sterilization

    MN1-5053 Rev. 15 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 44: Liquid Sterilization (Usa Only)

    MN1-5053 Rev. 15 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 45: Actions Before Storing The Probe

    MN1-5053 Rev. 15 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 46 MN1-5053 Rev. 15 -40-...
  • Page 47: Moving And Transporting

    MN1-5053 Rev. 15 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 48 MN1-5053 Rev. 15 -42-...
  • Page 49: Periodic Inspection

    MN1-5053 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 50: Testing Of Measurement Tolerances

    MN1-5053 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 51: Configuration

    MN1-5053 Rev. 15 9. Configuration 9-1. Standard configuration Probe UST-547 ................1 set Storage case CB-UST1-P1 ...............1 set Instruction manual MN1-5053 ................1 copy -45-...
  • Page 52 MN1-5053 Rev. 15 -46-...
  • Page 53: Disposal Of The Device

    MN1-5053 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 54 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 Ultrasound Logistics, Zweigniederlassung der Hitachi Medical Systems Europe Holding AG Carl-Zeiss-Strasse 5, D-72555 Metzingen, Germany EU Importer: Hitachi Medical Systems Europe Holding AG Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland...

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