Hitachi UST-9124 Instruction Manual
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Hitachi UST-9124 Instruction Manual

Transvaginal electronic convex probe
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Transvaginal Electronic Convex Probe
UST-9124
Instruction Manual
MN1-1162 Rev.21
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-9124

  • 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 MN1-1162 Rev.21...
  • Page 3 MN1-1162 Rev.21 Introduction This is an instruction for model UST-9124, 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

    MN1-1162 Rev.21 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. Option usage precautions ....................... 4 1-2-3. Cleaning, disinfection and sterilization precautions ..............5 1-2-4. Labels ............................. 6 2. Specifications and Parts name 2-1.
  • Page 5 MN1-1162 Rev.21 5-3. Point of use (Pre-cleaning) .....................29 5-4. Containment and transportation ..................29 5-5. Manual cleaning and disinfection ...................30 ......................31 5-5-1. Manual cleaning ....................32 5-5-2. Manual disinfection ....................33 5-5-3. Cable and connector 5-6. Automated cleaning and disinfecting ................33 5-7. Applicable cleaners and disinfectants / Suppliers List ...........34 5-8.
  • Page 6 MN1-1162 Rev.21...

  • Page 7: Safety Precautions

    MN1-1162 Rev. 21 1. Safety Precautions 1-1. Intended use This probe is intended for use by a doctor or other qualified operator for inserting into 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

    MN1-1162 Rev. 21 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 MN1-1162 Rev. 21 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

    Use Hitachi-approved rubber boots only. Use of an item lacking biocompatibility can cause an adverse reaction of the human body. Check that the rubber boot is sterilized.

  • Page 11: Cleaning, Disinfection And Sterilization Precautions

    MN1-1162 Rev. 21 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 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

    MN1-1162 Rev. 21 1-2-4. Labels (1) Probe unit Label 1 Label 2 Label 3 Label 4 Label 1 Electronic convex probe mark Frequency...
  • Page 13 MN1-1162 Rev. 21 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 MN1-1162 Rev. 21 (2) Storage case Label A Label B...
  • Page 15 MN1-1162 Rev. 21 Label A(Examples) Model 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 16 MADE IN JAPAN Label for 10 pieces 10 pieces Rx Only RUBBER BOOT RB-945BP-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 Lot number By prescription only.

  • Page 17: Specifications And Parts Name

    MN1-1162 Rev. 21 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

    MN1-1162 Rev. 21 2-2. Specifications Application regions: Obstetric and gynecological areas Form of application to patient: Transvaginal Connectable instruments: SSD-4000, SSD-3500, SSD-1000, ProSound 6, ProSound α 6, F37, F31 Field of view: 180 ° Frequency: 3.0 to 8.5 MHz Cable length: 2.5 m Weight: 1,095 g...

  • Page 19: Performance

    MN1-1162 Rev. 21 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 Rubber boot This covers the insertion portion for preventing infection. Follow the instructions in section 4-2. Handle The dimple corresponds to the This section is held when performing insertion,...

  • Page 20: Environmental Conditions

    MN1-1162 Rev. 21 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 21: Preparations For Use

    MN1-1162 Rev. 21 3. Preparations for Use 3-1. Startup 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 MN1-1162 Rev. 21 -16-...

  • Page 23: Usage

    MN1-1162 Rev. 21 4. Usage 4-1. Operation Check that the rubber boot is mounted, and insert the probe 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

    Use Hitachi-approved rubber boots only. Use of an item lacking biocompatibility can cause an adverse reaction of the human body. Check that the rubber boot is sterilized.

  • Page 25: Removal Of Rubber Boot

    MN1-1162 Rev. 21 4-3. Removal of rubber boot 1. Wrap the rubber boots in tissue paper and remove it from the probe. 2. Dispose used tissue paper and rubber boots using infection prevention procedures based on the rules of your facility. Caution Before disposing the equipment, disinfect or take other infection-prevention measures.

  • Page 26: Connecting To Ultrasound Diagnostic Instrument

    MN1-1162 Rev. 21 4-4. Connecting to 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 27: Removing From The Ultrasound Diagnostic Instrument

    MN1-1162 Rev. 21 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.

  • Page 28: Precautions When Performing Puncture Operations

    MN1-1162 Rev. 21 4-6. Precautions when performing puncture operations Warning Carefully read the usage precautions in the documentation supplied with the puncture guide tube. 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 29: Actions To Be Taken When An Abnormal State Is Detected

    MN1-1162 Rev. 21 4-7. Actions to be taken when an abnormal state is detected 4-7-1. 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. 4-7-2.
  • Page 30 MN1-1162 Rev. 21 -24-...

  • 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-9124 Accessories Washing brush Size(M)L-Ki-266, Size(L)L-Ki-265 Note: X means “Applicable” : Automated Need waterproof cover...

  • Page 32: Precautions For Cleaning, Disinfection And Sterilization

    MN1-1162 Rev. 21 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

    MN1-1162 Rev. 21 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 MN1-1162 Rev. 21 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...

  • Page 35: Point Of Use (Pre-Cleaning)

    MN1-1162 Rev. 21 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 puncture guide tube and rubber boot. 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

    MN1-1162 Rev. 21 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 37: Manual Cleaning

    MN1-1162 Rev. 21 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 38: Manual Disinfection

    MN1-1162 Rev. 21 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 39: Cable And Connector

    MN1-1162 Rev. 21 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 40: Applicable Cleaners And Disinfectants / Suppliers List

    MN1-1162 Rev. 21 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 41 MN1-1162 Rev. 21 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 42: Drying

    MN1-1162 Rev. 21 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 43: Sterilization

    MN1-1162 Rev. 21 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 44: Sterrad ® Sterilization

    MN1-1162 Rev. 21 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 45: Liquid Sterilization (Usa Only)

    MN1-1162 Rev. 21 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 46 MN1-1162 Rev. 21 -40-...

  • Page 47: Actions Before Storing The Probe

    MN1-1162 Rev. 21 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 48 MN1-1162 Rev. 21 -42-...

  • Page 49: Moving And Transporting

    MN1-1162 Rev. 21 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 50 MN1-1162 Rev. 21 -44-...

  • Page 51: Periodic Inspection

    MN1-1162 Rev. 21 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 52: Testing Of Measurement Tolerances

    MN1-1162 Rev. 21 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 53: Configuration

    MN1-1162 Rev. 21 9. Configuration 9-1. Standard configuration Probe UST-9124 ................1 set Storage case CB-UST1-P1 or CB-UST5-P1 ..........1 set Instruction manual MN1-1162 ................1 copy 9-2. Options • Puncture guide tube The following puncture guide tubes are provided for various puncture needle sizes.
  • Page 54 MN1-1162 Rev. 21 -48-...

  • Page 55: Disposal Of The Device

    MN1-1162 Rev. 21 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 56 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 -50- MN1-1162 Rev. 21 ’17.01.11...

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