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Hitachi UST-5550 Instruction Manual

Intraoperative electronic linear probe, compatible with waterproof cover
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Intraoperative Electronic Linear Probe
UST-5550 (Compatible with waterproof cover)
Instruction Manual
MN1-5575 Rev.11
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-5550

  • 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 MN1-5575 Rev.11...
  • Page 3 MN1-5575 Rev.11 Introduction This is an instruction for model UST-5550, 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

    MN1-5575 Rev.11 CONTENTS 1. Safety Precautions 1-1. Intended use ........................1 1-2. Usage precautions ......................1 ..................2 1-2-1. Warnings and safety information ............4 1-2-2. Cleaning, disinfection and sterilization precautions ........................6 1-2-3. Labels 2. Specifications and Parts name 2-1. Principles of operation ....................11 2-2.
  • Page 5 MN1-5575 Rev.11 4-3. Removing from the ultrasound diagnostic instrument ...........25 4-4. Actions to be taken when an abnormal state is detected ..........26 ..................26 4-4-1. Ensuring safety of patients ....................26 4-4-2. Handling the instrument 5. Cleaning, disinfection and sterilization 5-1. Precautions for cleaning, disinfection and sterilization ..........28 5-2.
  • Page 6 MN1-5575 Rev.11 8. Periodic Inspection 8-1. Safety tests ........................49 8-2. Testing of measurement tolerances .................50 ......................50 8-2-1. Conducting tests ......................50 8-2-2. Result judgement 9. Configuration 9-1. Standard configuration ....................51 9-2. Options..........................51 10. Disposal of the Device .......................53 This Instruction Manual contains the main body of 54pages and 6pages until the CONTENTS.

  • Page 7: Safety Precautions

    MN1-5575 Rev. 11 1. Safety Precautions 1-1. Intended use This probe is intended for use by a doctor when placed into direct contact with human internal organs during surgery making ultrasonic observations. 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

    MN1-5575 Rev. 11 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 MN1-5575 Rev. 11 Warning During surgery , be sure to wear sterilized medical gloves. Conducting examinations with the bare hands can expose the operator to a risk of infection. For the acoustic medium, use sterilized physiological saline. Using an unsterilized ultrasound medium can cause an infection on the patient. Dispose the probe used for patients with Creutzfeldt-Jakob disease.

  • Page 10: Cleaning, Disinfection And Sterilization Precautions

    MN1-5575 Rev. 11 1-2-2. 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 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 11 MN1-5575 Rev. 11 Caution Attach the waterproof cover if the connector will be soaked in liquid. If the connector is soaked in liquid without the waterproof cover, liquid can get inside and result in malfunction. Attach the waterproof cover to the probe and use it by following the instructions in the waterproof cover manual.

  • Page 12: Labels

    MN1-5575 Rev. 11 1-2-3. Labels (1) Probe unit Label 1 Label 2 Label 3 Label 1 Electronic linear probe mark Frequency...
  • Page 13 MN1-5575 Rev. 11 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 MN1-5575 Rev. 11 (2) Storage case Label B Label A Label D Label C...
  • Page 15 MN1-5575 Rev. 11 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 16 MN1-5575 Rev. 11 -10-...

  • Page 17: Specifications And Parts Name

    MN1-5575 Rev. 11 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

    MN1-5575 Rev. 11 2-2. Specifications 2-2-1. Specifications of the probe Application regions: Intraoperative diagnosis Form of application to patient: Intraoperative Connectable instruments: SSD-α10, Prosound α7, Prosound α6, F37, ARIETTA 70, ARIETTA 60 Field of view: 38mm Frequency: 7.5MHz Range of deflection: UP120°...

  • Page 19: Specifications Of The Protect Tube

    MN1-5575 Rev. 11 2-2-2. Specifications of the protect tube Material: Polyetherimide ( Protect tube ), Silicon rubber ( Cap ) Compatible trocar size: 12mm Service life: Three years External dimensions: As shown in the figure below. Unit: mm Remarks The dimensions and weight are within ±10% of the indicated values. -13-...

  • Page 20: Performance

    MN1-5575 Rev. 11 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 Cable Angle markers Angle knob This cable propagates the The angle marker is a white ultrasonic signals that are This part is used to operate line that indicats the angle...

  • Page 21: Environmental Conditions

    MN1-5575 Rev. 11 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 MN1-5575 Rev. 11 -16-...

  • Page 23: Preparations For Use

    MN1-5575 Rev. 11 3. Preparations for Use Warning Be sure to preparations for use. Using the equipment without noticing an abnormal condition can result in injury to the operator or patient. If an inspection finds an abnormal condition in the equipment, immediately stop use and contact one of our offices and/or distributor's offices listed on the back cover.

  • Page 24: Probe Insertion Check

    MN1-5575 Rev. 11 3-1-4. Probe insertion check With the protect tube locked to the trocar outer sheath, insert the probe into the protect tube and make sure the probe can be smoothly inserted/removed. 3-1-5. Verification of operation Connect to the ultrasound diagnostic instrument by following the instructions in section 4-2, “Connecting to the ultrasound diagnostic instrument"...

  • Page 25: Usage

    MN1-5575 Rev. 11 4. Usage Warning Carefully read section 1 "Safety Precautions" before use. Incorrect use can result in an injury to the patient. Be sure to following the safety precautions when operating. 4-1. Operation 4-1-1. Operation of each part ・...

  • Page 26: Preparations Of The Protect Tube

    MN1-5575 Rev. 11 ・ Angle marker The angle marker is a white line that indicats the angle of the deflection portion. When the two white lines coincide it means that the deflection portion is nearly straight. White lines 4-1-2. Preparations of the protect tube Attach the cap to protect tube.
  • Page 27 MN1-5575 Rev. 11 ③ Gently insert the tip of the probe into the insertion opening Probe of the protect tube. ④ 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.

  • Page 28: Pulling Out The Probe

    MN1-5575 Rev. 11 4-1-4. Pulling out the probe Angle knob ① Manipulate the angle knob in FREE condition of the lock lever and straighten the deflection portion of the probe while checking the angle marker. Deflection portion of probe Probe ②...
  • Page 29 MN1-5575 Rev. 11 Warning To remove the probe, set free the angle knob and straighten the deflection portion. Removing it while it is locked may injure the patient. Whenever you feel a resistance in the probe, stop its operation. Be sure to sterilize the probe and accessories which blood adhered. Otherwise, there is a risk of infection.

  • Page 30: Connecting To The Ultrasound Diagnostic Instrument

    MN1-5575 Rev. 11 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 electronic probe connecting socket of the diagnostic instrument ( probe connector ).

  • Page 31: Removing From The Ultrasound Diagnostic Instrument

    MN1-5575 Rev. 11 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.

  • Page 32: Actions To Be Taken When An Abnormal State Is Detected

    MN1-5575 Rev. 11 4-4. Actions to be taken when an abnormal state is detected 4-4-1. 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. 4-4-2.

  • 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-5550 MP-2485B Note: X means “Applicable” : Automated Need waterproof cover : Liquid sterilization USA only -27-...

  • Page 34: Precautions For Cleaning, Disinfection And Sterilization

    MN1-5575 Rev. 11 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 35 MN1-5575 Rev. 11 Caution Attach the waterproof cover if the connector will be soaked in liquid. If the connector is soaked in liquid without the waterproof cover, liquid can get inside and result in malfunction. Attach the waterproof cover to the probe and use it by following the instructions in the waterproof cover manual.

  • Page 36: Reprocessing Instruction According To Iso 17664

    MN1-5575 Rev. 11 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 37 MN1-5575 Rev. 11 Flowchart of reprocessing process of this probe and accessories is as follows: Point of use (Pre-cleaning) Waterproof cover (If necessary) Containment and transportation Manual cleaning and disinfection Washer disinfector (WD) Manual cleaning Rinsing after manual cleaning Automated cleaning Drying Automated disinfection Manual disinfection...

  • Page 38: Point Of Use (Pre-Cleaning)

    MN1-5575 Rev. 11 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 protect tube. 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 39: Manual Cleaning And Disinfection

    MN1-5575 Rev. 11 5-6. 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 40: Manual Cleaning

    MN1-5575 Rev. 11 5-6-1. 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 41: Manual Disinfection

    MN1-5575 Rev. 11 5-6-2. 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. Test strips ®...

  • Page 42: Cable And Connector

    MN1-5575 Rev. 11 5-6-3. 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 43 MN1-5575 Rev. 11 B). Protect tube MP-2485B The following items must be provided prior to automated cleaning and disinfection: a) Washer disinfector: according to ISO 15883 with chemo-thermal program (temperature: max 60 °C[140°F]). b) Detergent: Korsolex Endo-Cleaner (Bode Chemie; # 972 020) or another cleaning agent with approved material compatibility for this medical device.

  • Page 44: Applicable Cleaners And Disinfectants / Suppliers List

    MN1-5575 Rev. 11 5-8. 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 45 MN1-5575 Rev. 11 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% ® ADVANCED STERILIZATION PRODUCTS Cidex plus ®...

  • Page 46: Drying

    MN1-5575 Rev. 11 5-9. 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 47: Sterilization

    MN1-5575 Rev. 11 5-12. 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 48: Sterrad ® Sterilization

    MN1-5575 Rev. 11 5-12-2. 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 49: Liquid Sterilization (Usa Only)

    MN1-5575 Rev. 11 5-12-3. 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 50 MN1-5575 Rev. 11 -44-...

  • Page 51: Actions Before Storing The Probe

    MN1-5575 Rev. 11 6. Storage 6-1. Actions before storing the probe When the equipment 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. Caution Be sure to store the waterproof cover by removing it from the connector.
  • Page 52 MN1-5575 Rev. 11 -46-...

  • Page 53: Moving And Transporting

    MN1-5575 Rev. 11 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 equipment 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 54 MN1-5575 Rev. 11 -48-...

  • Page 55: Periodic Inspection

    MN1-5575 Rev. 11 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 56: Testing Of Measurement Tolerances

    MN1-5575 Rev. 11 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 57: Configuration

    MN1-5575 Rev. 11 9. Configuration 9-1. Standard configuration Probe UST-5550 ................1 set Protect tube MP-2485B ................1 set Cap (spare) .................2 Storage case STB-45-PA3 ...............1 set Instruction manual MN1-5575 ................1 copy 9-2. Options Waterproof cover MP-2790 Attaching the waterproof cover (MP-2790) (option) enables sorking in liquid up to the connector.
  • Page 58 MN1-5575 Rev. 11 -52-...

  • Page 59: Disposal Of The Device

    MN1-5575 Rev. 11 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 60 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 -54- MN1-5575 Rev. 11 ’17.01.11...

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