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Hitachi UST-9135P Instruction Manual

Puncture electronic convex probe
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Puncture Electronic Convex Probe
UST-9135P
Instruction Manual
MN1-5315 Rev.14
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-9135P

  • 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 MN1-5315 Rev.14...
  • Page 3 MN1-5315 Rev.14 Introduction This is an instruction for model UST-9135P, 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

    MN1-5315 Rev.14 CONTENTS 1. Safety Precautions 1-1. Intended use ........................1 1-2. Usage precautions ......................1 1-2-1. Warnings and safety information....................1-2-2. Puncture precautions ........................1-2-3. Cleaning, disinfection and sterilization precautions ..............1-2-4. Labels ............................. 2. Specifications and Parts name 2-1. Principles of operation ....................13 2-2.
  • Page 5 MN1-5315 Rev.14 4. Usage 4-1. Operation ........................23 4-2. Attaching of the needle guide, the guard plate and the lock plate ........24 4-3......................25 Leaving the needle 4-4. Removal of the needle guide, the guard plate and the lock plate ........25 4-5.
  • Page 6 MN1-5315 Rev.14 6. Storage 6-1. Actions before storing ....................47 6-2. Environmental conditions for storage ................47 7. Moving and Transporting 7-1. Moving and transporting ....................49 7-2. Preparing the probe and accessories for moving ............49 7-3. Packing for transportation ....................49 7-4. Environmental conditions during transportation ............49 8.

  • Page 7: Safety Precautions

    MN1-5315 Rev. 14 1. Safety Precautions 1-1. Intended use This probe is intended for use by a doctor when placed into direct contact with the skin making ultrasonic observations of surrounding organs. It also enables the doctor to guide the puncture needle under the ultrasound guide into the patient's body. Caution Do not use this equipment for other than its intended purpose.

  • Page 8: Warnings And Safety Information

    MN1-5315 Rev. 14 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 MN1-5315 Rev. 14 Caution Constantly check for anything abnormal about the patient’s condition, 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: Puncture Precautions

    MN1-5315 Rev. 14 1-2-2. Puncturing precautions Warning 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 ultrasound diagnostics and who is skilled and has a thorough knowledge of puncture operations under an ultrasound guide.
  • Page 11 MN1-5315 Rev. 14 Warning Do not puncture the heart region. Puncturing the heart region may cause a micro electric shock. Check that no other organs lie in the puncture path. If another organ lies in the puncture path, an unintended body part can be punctured and cause an injury to the patient.
  • Page 12 MN1-5315 Rev. 14 Caution Handle the needle carefully to ensure that the probe, the needle guide, the guard plate and the lock plate are not damaged. Using the probe, the needle guide, the guard plate and the lock plate that have been damaged by a needle can result in an injury to the operator or patient.

  • Page 13: Cleaning, Disinfection And Sterilization Precautions

    MN1-5315 Rev. 14 1-2-3. Cleaning, disinfection and sterilization precautions Warning Wear protective gloves and other protective gear during cleaning, disinfection and sterilization. Handling of the equipment with your 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 14: Labels

    MN1-5315 Rev. 14 1-2-5. Labels (1) Probe unit Label 1 Label 2 Label 3 Label 1 Electronic convex probe mark Frequency...
  • Page 15 MN1-5315 Rev. 14 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 16 MN1-5315 Rev. 14 (2) Storage case Label B Label A Label D Label C -10-...
  • Page 17 MN1-5315 Rev. 14 Label A Model Label B Serial No. 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 18 MN1-5315 Rev. 14 -12-...

  • Page 19: Specifications And Parts Name

    MN1-5315 Rev. 14 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 20: Specifications

    MN1-5315 Rev. 14 2-2. Specifications 2-2-1. Specifications of the probe Application regions: Surface puncturing, abdomen, general areas Form of application to patient: Surface Connectable instruments: Prosound α7, SSD-α10, Prosound F75, F37 Field of view: 60° Frequency: 3.5 MHz Cable length: 2.0 m Weight: 1100 g...

  • Page 21: Specifications Of The Needle Guide

    MN1-5315 Rev. 14 2-2-2. Specifications of the needle guide Material Polyetherimide (Needle guide, lock plate) Stainless steel (Guard plate) Needle guide, usable puncture needle size and diameter Standard MP-2785-G18 : 18G(1.26±0.02mm) Option MP-2785-G25 : 25G(0.51±0.01mm) MP-2785-G23 : 23G(0.63±0.02mm) MP-2785-G22 : 22G(0.71±0.02mm) MP-2785-G21 : 21G(0.81±0.02mm) MP-2785-G20 : 20G(0.88±0.02mm) MP-2785-G19 : 19G(1.06±0.02mm)

  • Page 22: Performance

    MN1-5315 Rev. 14 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 V-groove Cable Probe tip The needle guide is inserted to This cable propagates the ultrasonic This area is held during operation.

  • Page 23: Environmental Conditions

    MN1-5315 Rev. 14 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 24 MN1-5315 Rev. 14 -18-...

  • Page 25: Preparations For Use

    MN1-5315 Rev. 14 3. Preparations for Use 3-1. Start up check of the probe 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.

  • Page 26: Startup Check Of The Needle Guide

    MN1-5315 Rev. 14 3-2. Start up check of the needle guide 3-2-1. Visual check Check that the needle guide, the guard plate and the lock plate are not in the abnormal conditions listed below. • Abnormalities seen in visual such as deformation, cracks, abnormal gaps, damage, foreign matter adhering, severe discoloration.

  • Page 27: Checking The Needle Echo

    MN1-5315 Rev. 14 3-3. Checking the needle echo 3-3-1. Check preparation (1) Required items (Depth of 20 cm or more) Warm water 40°C (104°F) Thermometer Probe Needle guide MP-2785-G18 (standard configuration) or others (user's selection of the options) Puncture needle Size : 18G (standard configuration) or others (depend on user's selection) Length : 150 mm to 200 mm (2) Setup procedure...

  • Page 28: Checking The Needle Echo

    MN1-5315 Rev. 14 3-3-2. Checking the needle echo (1) Dip the probe tip into the warm water so that the needle echo is displayed. (2) Check the following points. • The needle echo matches with the puncture guide line. • The echo of the entire needle is displayed fully and clearly. Image on the monitor screen Needle echo Puncture guide line...

  • Page 29: Usage

    MN1-5315 Rev. 14 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 30: Attaching Of The Needle Guide, The Guard Plate And The Lock Plate

    MN1-5315 Rev. 14 4-2. Attaching of the needle guide, the guard plate and the lock plate (1) Insert the lock plate into the probe from the front mark side as deep as it will go by aligning the groove of the lock plate with the probe guide.

  • Page 31: Leaving The Needle

    MN1-5315 Rev. 14 4-3. Leaving the needle The probe and the neede guide can be removed from the puncture needle during puncturing. (1) Slide the lock plate to the opposite side of the front mark. Slide the lock plate to opposite side of the front (2) Lift up and remove the needle guide.

  • Page 32: Connecting To The Ultrasound Diagnostic Instrument

    MN1-5315 Rev. 14 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 33: Removing From The Ultrasound Diagnostic Instrument

    MN1-5315 Rev. 14 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 34: Puncturing Precautions

    MN1-5315 Rev. 14 4-7. Puncturing precautions Warning 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 ultrasound diagnostics and who is skilled and has a thorough knowledge of puncture operations under an ultrasound guide.
  • Page 35 MN1-5315 Rev. 14 Warning Do not puncture the heart region. Puncturing the heart region may cause a micro electric shock. Check that no other organs lie in the puncture path. If another organ lies in the puncture path, an unintended body part can be punctured and cause an injury to the patient.

  • Page 36: Actions To Be Taken When An Abnormal State Is Detected

    MN1-5315 Rev. 14 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 37: 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-9135P MP-2785-G18 MP-2785-LP MP-2785-BP Note: X means “Applicable” : Automated Need waterproof cover : Liquid sterilization USA only...

  • Page 38: Precautions For Cleaning, Disinfection And Sterilization

    MN1-5315 Rev. 14 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 39: Reprocessing Instruction According To Iso 17664

    MN1-5315 Rev. 14 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 40 MN1-5315 Rev. 14 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 41: Point Of Use (Pre-Cleaning)

    MN1-5315 Rev. 14 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 needle guide, the lock plate and the guard plate. 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 42: Manual Cleaning And Disinfection

    MN1-5315 Rev. 14 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 43: Manual Cleaning

    MN1-5315 Rev. 14 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 44: Manual Disinfection

    MN1-5315 Rev. 14 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 45: Cable And Connector

    MN1-5315 Rev. 14 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 46: Applicable Cleaners And Disinfectants / Suppliers List

    MN1-5315 Rev. 14 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 47 MN1-5315 Rev. 14 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 48: Drying

    MN1-5315 Rev. 14 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 the cavities of the probe by applying compressed air.

  • Page 49: Sterilization

    MN1-5315 Rev. 14 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 50: Sterrad ® Sterilization

    MN1-5315 Rev. 14 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 51: Liquid Sterilization (Usa Only)

    MN1-5315 Rev. 14 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 52 MN1-5315 Rev. 14 -46-...

  • Page 53: Storage

    MN1-5315 Rev. 14 6. Storage 6-1. Actions before storing 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. Clean, disinfect and sterilize the needle guide, the guard plate and the lock plate and store them under sterile condition.
  • Page 54 MN1-5315 Rev. 14 -48-...

  • Page 55: Moving And Transporting

    MN1-5315 Rev. 14 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 and the storage tray after performing the procedure in section 5 “Cleaning, disinfection and sterilization".
  • Page 56 MN1-5315 Rev. 14 -50-...

  • Page 57: Periodic Inspection

    MN1-5315 Rev. 14 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 58: Testing Of Measurement Tolerances

    MN1-5315 Rev. 14 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 59: Safety Tests Of The Puncture Adapter

    MN1-5315 Rev. 14 8-3. Safety tests of the needle guide Conduct a periodic safety tests at least once a year by referring to section 3-2 "Start up check of the needle guide" and section 3-3 "Checking the needle echo". Also conduct the safety tests for the probe that is used. Warning Be sure to perform a safety test at least once a year.
  • Page 60 MN1-5315 Rev. 14 -54-...

  • Page 61: Configuration

    MN1-5315 Rev. 14 9. Configuration 9-1. Standard configuration Probe UST-9135P .................1 set Needle guide MP-2785-G18 ..............1 piece Lock plate MP-2785-LP ...............1 piece Guard plate MP-2785-BP ...............1 piece Storage tray MP-2698 ................1 set Storage case STB-45-PA1 ...............1 set Instruction manual MN1-5315 ................1 copy 9-2.
  • Page 62 MN1-5315 Rev. 14 -56-...

  • Page 63: Disposal Of The Device

    MN1-5315 Rev. 14 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 64 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 -58- MN1-5315 Rev.14 ’17.01.11...

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