Hitachi ASU-1014 Instruction Manual
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Hitachi ASU-1014 Instruction Manual

Hitachi ASU-1014 Instruction Manual

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Electronic Convex Sector Scanner
ASU-1014
Instruction Manual
MN1-5933 Rev.5
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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  • 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 MN1-5933 Rev.5 -ii-...
  • Page 3 MN1-5933 Rev.5 Introduction This is an instruction for model ASU-1014, an ultrasound scanner. 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 scanner indicates that this scanner 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

    MN1-5933 Rev.5 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 ..................3 1-2-3. Labels ................................4 2. Specifications and Parts name ........................9 2-1. Principles of operation ..............................9 2-2.
  • Page 5 MN1-5933 Rev.5 5-5-1. Manual cleaning ............................24 5-5-2. Manual disinfection .............................25 5-5-3. Cable and connector .............................25 5-6. Automated cleaning and disinfecting ........................26 5-7. Applicable cleaners and disinfectants / Suppliers List ....................27 5-8. Drying ..................................29 5-9. Maintenance, inspection and testing...........................29 5-10. Packaging ..................................29 5-11.
  • Page 6 MN1-5933 Rev.5 -vi-...

  • Page 7: Safety Precautions

    MN1-5933 Rev.5 1. Safety Precautions 1-1. Intended use This scanner 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

    MN1-5933 Rev.5 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 scanner. 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: Cleaning, Disinfection And Sterilization Precautions

    MN1-5933 Rev.5 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: Labels

    MN1-5933 Rev.5 1-2-3. Labels (1) Scanner unit Label 1 Label 2 Label 3 Label 1 Electronic convex mark Frequency...
  • Page 11 MN1-5933 Rev.5 Label2 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 12 MN1-5933 Rev.5 (2) Storage case Label A Label B...
  • Page 13 MN1-5933 Rev.5 Label A Model Serial No. Label B 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 (in case of 2016-09)
  • Page 14 MN1-5933 Rev.5...

  • Page 15: Specifications And Parts Name

    MN1-5933 Rev.5 2. Specifications and Parts name 2-1. Principles of operation This scanner 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 scanner, 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 16: Specifications

    MN1-5933 Rev.5 2-2. Specifications Application regions: Obstetrics areas Form of application to patient: Surface Connectable instruments: Electronic scan field of view: 67° Mechanical scan field of view: Max 75° 5 MHz ± 30% Frequency: Cable length: 2.3 m Weight: 1,250 g Service life: Three years Range of applied part...

  • Page 17: Performance

    MN1-5933 Rev.5 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 This cable propagates the ultrasonic signals Scanner tip that are sent and received. This area is held during operation.

  • Page 18: Environmental Conditions

    MN1-5933 Rev.5 2-5. Environmental conditions Use and store the scanner 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 19: Preparations For Use

    MN1-5933 Rev.5 3. Preparations for Use 3-1. Start up check 3-1-1. Visual check Visually check the scanner 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 20 MN1-5933 Rev.5 -14-...

  • Page 21: Usage

    MN1-5933 Rev.5 4. Usage 4-1. Operation Bring the ultrasonic irradiation area of the scanner 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 22: Connecting To The Ultrasound Diagnostic Instrument

    MN1-5933 Rev.5 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 probe connector. Connect the scanner to the electronic probe connecting socket of the diagnostic instrument ( probe connector ) by following the procedure below.

  • Page 23: Removing From The Ultrasound Diagnostic Instrument

    MN1-5933 Rev.5 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. Use the procedure below to remove the scanner from the electronic scan probe connector of the ultrasound diagnostic instrument (probe connector).

  • Page 24: Actions To Be Taken When An Abnormal State Is Detected

    MN1-5933 Rev.5 4-4. Actions to be taken when an abnormal state is detected 4-4-1. Ensuring safety of patients Immediately move the scanner away from the patient and quit operation. Keep the patient in safe condition and administer the required medical treatment. 4-4-2.

  • Page 25: 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 ASU-1014 Note: X means “Applicable” : Automated Need waterproof cover : Liquid sterilization USA only -19-...

  • Page 26: Precautions For Cleaning, Disinfection And Sterilization

    MN1-5933 Rev.5 5-1. Precautions for cleaning, disinfection and sterilization The following warnings and cautions must be observed when cleaning, disinfecting and sterilizing the scanner and accessories. Warning Wear protective gloves and other protective gear during cleaning, disinfection and sterilization. Handling of the scanner with your bare hands before sterilization can result in an infection. After finishing soaking the scanner in cleaning agents, thoroughly wash it with running water.

  • Page 27: Reprocessing Instruction According To Iso 17664

    MN1-5933 Rev.5 5-2. Reprocessing instruction according to ISO 17664 Take care about clean circumstances before using the scanner on the next patients. If processors reprocess this equipment, refer to these instructions. Table 1 ・ The scanner is delivered unsterile. Prior to the first use, reprocess the scanner. ・...
  • Page 28 MN1-5933 Rev.5 Flowchart of reprocessing process of this scanner 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 -22-...

  • Page 29: Point Of Use (Pre-Cleaning)

    MN1-5933 Rev.5 5-3. Point of use (Pre-cleaning) In the operating room after use of the scanner Scanner 1) Flush patient’s blood or fluid by tap water directly after use until the surface looks visually clean. 2) Wipe the whole surface of the scanner by gauze pad and remove superficial visible impurities until the surface looks visually clean.

  • Page 30: Manual Cleaning And Disinfection

    MN1-5933 Rev.5 5-5. Manual cleaning and disinfection Prepare following items before manual cleaning and disinfection. Scanner 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 31: Manual Disinfection

    MN1-5933 Rev.5 5-5-2. Manual disinfection Scanner 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 to verify that the appropriate concentration of Cidex OPA is correct are ®...

  • Page 32: Automated Cleaning And Disinfecting

    MN1-5933 Rev.5 5-6. Automated cleaning and disinfecting Scanner Warning The scanner cannot withstand Automated cleaning and disinfecting. -26-...

  • Page 33: Applicable Cleaners And Disinfectants / Suppliers List

    MN1-5933 Rev.5 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 34 MN1-5933 Rev.5 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 35: Drying

    MN1-5933 Rev.5 5-8. Drying Scanner 1) Wipe the scanner 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 36: Sterilization

    MN1-5933 Rev.5 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 37: Storage

    MN1-5933 Rev.5 6. Storage 6-1. Actions before storing the scanner When the scanner 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 38 MN1-5933 Rev.5 -32-...

  • Page 39: Moving And Transporting

    MN1-5933 Rev.5 7. Moving and Transporting 7-1. Moving and transporting In this section, moving refers to "carrying of the scanner within a facility" and transporting refers to "transferring using a vehicle or sending the scanner for repairs". 7-2. Preparing the scanner and accessories for moving Store in the storage case after performing the procedure in section 5 “Cleaning, disinfection and sterilization”.
  • Page 40 MN1-5933 Rev.5 -34-...

  • Page 41: Periodic Inspection

    MN1-5933 Rev.5 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 42: Testing Of Measurement Tolerances

    MN1-5933 Rev.5 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 43: Configuration

    MN1-5933 Rev.5 9. Configuration 9-1. Standard configuration Scanner ASU-1014 ................1 set Storage case CB-UST1-P1 ...............1 set Instruction manual MN1-5933 ................1 copy -37-...
  • Page 44 MN1-5933 Rev.5 -38-...

  • Page 45: Disposal Of The Device

    MN1-5933 Rev.5 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 46 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 -40- MN1-5933 Rev.5 ’17.01.11...

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