Hitachi VC34A Probe Instruction Manual
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Hitachi VC34A Probe Instruction Manual

Hitachi VC34A Probe Instruction Manual

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VC34A Probe
INSTRUCTION MANUAL
Notes for operators and responsible maintenance personnel
★ Please read through this Instruction Manual carefully prior to use.
★ Keep this Instruction Manual together with the system with care to
make it available anytime.
Tokyo, Japan
Q1E-EP1398-4
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123
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Summary of Contents for Hitachi VC34A Probe

  • 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 system with care to make it available anytime. Tokyo, Japan Q1E-EP1398-4 © Hitachi, Ltd. 2013,2017. All rights reserved. 0123...
  • Page 2 Manufacturer: Hitachi, Ltd. 2-16-1, Higashi-Ueno, Taito-ku, Tokyo,110-0015, Japan +81-3-6284-3668 http://www.hitachi.com/businesses/healthcare/ index.html European Representative: 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 Local Distributor: Q1E-EP1398...
  • Page 3 VC34A Probe. The manual also contains the general information and the specification of the probe. The probe is usable with the HITACHI ultrasound diagnostic scanner. The operation of the HITACHI ultrasound diagnostic scanner shall be referred to its instruction manual.
  • Page 4 Graphical Symbols for Use in Labeling of Hitachi Ultrasound Probes Some graphical symbols that are used in labeling of Hitachi Ultrasound Probes are compliant with EN980:2008 standard. Refer to the following table about the meanings of them. Explanation of Symbol...
  • Page 5 Definition of symbol The following symbol is also used for HITACHI Ultrasound Probes. Location Symbol Definition This instrument complies with Directive 93/42/EEC relating to Medical Device Probe connector and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.5...

  • Page 6: Table Of Contents

    CONTENTS Page 1. General ............1 1.1 General............. 1 1.2 Principles of operation........1 1.3 Intended Use..........2 1.4 Components..........2 1.5 External View..........3 2. Inspection before Use .......... 4 2.1 Inspection for Appropriate Connection....... 4 2.2 Inspection for Material Surface......4 3.

  • Page 7: General

    General General The model VC34A Probe is a convex array electronic scanning type. The probe is capable of acquiring Real-time 3D image by mechanical drive of the acoustic elements. The acoustic output was measured with operating the Hitachi Ultrasound diagnostic scanner according to IEC60601-2-37. The measured acoustic output is listed in the instruction manual of the Hitachi ultrasound scanner.

  • Page 8: Intended Use

    Intended Use VC34A Probe is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner.  Fetal  Pediatric  Abdominal  Small organ WARNING Never use the probe for following applications.

  • Page 9: External View

    Disinfection has not been made to the probe, shipped from the factory. Prior to use of the probe, be sure to clean and disinfect the probe. External View The external view of VC34A Probe is shown in Fig. 1. Immersible part (IPX7) Scan head Handle housing...

  • Page 10: Inspection Before Use

    Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. Inspection for appropriate connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner. Inspection of material surface 2.2.1 Visually inspect the surface of the probe head, housing, the...

  • Page 11: Operation Procedure

    Operation Procedure 1) Confirm that the probe is cleaned and disinfected. 2) Covering the probe with a disposal probe cover to protect the probe is recommended. The probe cover should be allergy free material to avoid allergic reaction. Apply acoustic coupling gel inside and outside of the probe cover.

  • Page 12: Reprocessing Procedure

    Reprocessing Procedure The probe must be reprocessed after each use. Refer to the reprocessing instruction in this chapter ‐ The probe is delivered unsterile. Prior to the first use, reprocess the probe. ‐ WARNINGS Temperature should not exceed 40°C during reprocessing.
  • Page 13 Application part contacts Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Disinfection Application part contacts (Disinfectant with critical intracorporeal tissue directly virucidal effect - (operative application) minimum) Sterilization According to the intended use, VC34A probe is classified as uncritical. Q1E-EP1398...
  • Page 14 The flowchart of the reprocessing process of this probe is as follows. Point of use (Pre-cleaning) Containment and transportation Manual cleaning and disinfection Manual Cleaning Rinsing after manual cleaning Manual Disinfection Rinsing after manual disinfection Drying Q1E-EP1398...

  • Page 15: Point Of Use (Pre-Cleaning)

    4.1 Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after each use. (Pre-cleaning) The procedure is as follows: 1) Remove the probe cover. 2) Clean the probe of all patient’s blood or fluid with running tap water until the surface of the probe looks visually clean.
  • Page 16 Manual Cleaning: Prepare the detergent solution in a tank with cold water (please follow the instructions of the detergent manufacturer regarding application, dilution and contact time). 1) The temperature of the detergent solution should be between 15-30 °C, concentration is 1.6%. Please note the minimum contact time of the detergent in the manufacturer’s instruction.
  • Page 17 Manual disinfection: 1) Prepare the disinfectant solution in a tank with cold water (please follow the instructions of the disinfectant manufacturer regarding application, concentration, microbiological efficiency, service life and contact time). 2) Confirm the concentration of the disinfectant before immersing the probe.

  • Page 18: Drying

    Drying Drying 1) Wipe the probe with a single-use, fluff-free wipe or towel to remove moisture from the surface of the equipment. 2) Dry the probe naturally in an ambient temperature between 15-30°C for a minimum of 4 hours. Alternatively the probe can be dried using a drying heater at a temperature of less than 40°C.

  • Page 19: Maintenance And Safety Inspection

    Maintenance and Safety Inspection Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization. If you find any damage, do not use the probe, and immediately contact a service support. Inspect the functionality of Real-time 3D mode.

  • Page 20: Safety Precautions

    3) Use only detergents and disinfectants listed in “7.2 Suppliers list”. 4) Use sterile acoustic coupling gel depending on the diagnostic part. The acoustic coupling gel which is an accessory of Hitachi Ultrasound diagnostic scanner is non-sterile acoustic coupling gel.

  • Page 21: Specifications

    Specifications Probe Type : VC34A Probe Acoustic working : 5.0MHz frequency Technology : Convex Array Dimensions : See Fig. 4. Weight : Approx. 0.79kg (incl. cable and connector) Scanning angle : 67° Volume sweep angle : 75° Probe materials : Bio-compatible allergy free components...

  • Page 22: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with VC34A Probe. Product name Manufacturer Purpose Alkazyme ALKAPHARM Cleaner Klenzyme KLENZYME Cleaner CIDEZYME® Johnson & Johnson Cleaner Steranios 2% Laboratoires ANIOS High-level Disinfectant CIDEX® Johnson & Johnson High-level Disinfectant CIDEX®...

  • Page 23: Disposal Of The Probe

    Disposal of the probe 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.
  • Page 24 Unit:mm Fig. 4 Dimensions -18- Q1E-EP1398...

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