Hitachi EUP-C532 Instruction Manual
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Hitachi EUP-C532 Instruction Manual

Hitachi EUP-C532 Instruction Manual

Convex array probe
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Convex Array Probe
EUP-C532
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.
Q1E-EP0416-8
© Hitachi, Ltd. 2013,2017. All rights reserved.
0123

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Summary of Contents for Hitachi EUP-C532

  • 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. Q1E-EP0416-8 © 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-EP0416...
  • Page 3 About this manual This instruction manual contains safety precautions, the inspection, the operation procedure, and the reprocessing procedure of EUP-C532. Please read this manual thoroughly to ensure the safety operation. If you have any questions concerning the operation of the probe, please contact a service support.
  • 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 Probe connector 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.6.

  • Page 6: Table Of Contents

    2.1 Inspection for Appropriate Connection ······························· 4 2.2 Inspection for Material Surface ····································· 4 Operation Procedure ············································ 5 Magnetic Sensor for EUP-C532 ··································· 7 4.1 Magnetic Sensor (EZU-RV2S) ·········································· 7 4.2 Magnetic Sensor (EZU-RV3S) ········································· 13 Reprocessing Procedure ········································ 18 5.1 Point of use (Pre-cleaning) ········································...

  • Page 7: General

    General General The EUP-C532 is a Convex Array Probe. The acoustic output of the EUP-C532 was measured according to the IEC60601-2-37 standard and the measurement was conducted by operating with the Hitachi ultrasound diagnostic scanner. The measured acoustic output is listed in the instruction manual of the Hitachi ultrasound diagnostic scanner.

  • Page 8: Intended Use

    Intended Use The EUP-C532 is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner.  Neonatal  Pediatrics  Intra-operative WARNING Never use the probe for following applications.  Direct contact to the heart.

  • Page 9: External View

    External View The external view of the EUP-C532 is shown in Fig.1. Immersible part (IPX7) Head Cable Applied part Connector Spacer for EZU-RV2S (Option) Magnetic sensor attachment (Option) Magnetic sensor attachment (with needle guide bracket) (Option) Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water.

  • Page 10: Inspection Before Use

    Inspection before Use Prior to use, the probe and accessories must be carefully inspected that they are appropriate for use. If you find any damage, do not use them and contact a service support immediately. Inspection for Appropriate Connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner.

  • Page 11: Operation Procedure

    Operation Procedure Confirm that the probe, the Magnetic sensor attachment, and the Spacer for EZU-RV2S are disinfected and if necessary sterilized. Attach the attachment to the probe according to the chapter 4. Connect the probe to the ultrasound diagnostic scanner, operate the scanner, and adjust the image, all according to the instructions given in the operation manual for the ultrasound diagnostic scanner with which the probe is used as connected.
  • Page 12 Use a sterile probe cover to protect the probe. The probe cover should be allergy free material to avoid allergic reaction. Between the probe and the probe cover, acoustic coupling gel is required as a couplant. Place the probe on the examination site and adjust the probe’s position for a clear view of the desired image.

  • Page 13: Magnetic Sensor For Eup-C532

    Magnetic Sensor for EUP-C532 There are two types of magnetic sensors for the EUP-C532, the EZU-RV2S and the EZU-RV3S. The Magnetic sensor (EZU-RV2S) and the Magnetic sensor(EZU-RV3S) are shown in Fig.3 and Fig.9. The use of the EUP-C532 with either of the Magnetic sensors enables the user to perform RVS (Real-time Virtual Sonography).
  • Page 14 Needle guide bracket. Select one of the following attachments. Use without the Needle guide bracket Use with the Needle guide bracket “☆EUP-C532+GUIDE” indication “☆EUP-C532” indication Fig.4 Selection of the Magnetic sensor attachment Insert the magnetic sensor into the Magnetic sensor attachment with correct direction as shown in Fig.5.
  • Page 15 Attach the Magnetic sensor attachment to the probe with the correct direction as shown in Fig.6. Use without the Needle Guide Bracket Use with the Needle Guide Bracket Slit of the Projected part of Magnetic sensor the Magnetic sensor attachment attachment Fit the insertion direction...
  • Page 16 CAUTION  Never attach the Magnetic sensor attachment to the probe in the incorrect direction, otherwise it may result false diagnosis.  Never forget to attach the Spacer for EZU-RV2S to the Magnetic sensor, otherwise it may result in false diagnosis. -10- Q1E-EP0416...
  • Page 17 4.1.2 How to release the Magnetic Sensor The procedure of releasing the Magnetic sensor from the probe is as follow. Push the Magnetic sensor attachment and release it from the probe as shown in Fig.7. Use without the Needle Guide Bracket Use with the Needle Guide Bracket Push here Push here...
  • Page 18 Release the Magnetic sensor from the Magnetic sensor attachment as shown in Fig.8. Use without the Needle guide bracket Use with the Needle guide bracket Fig.8 How to release the magnetic sensor CAUTION The Spacer for EZU-RV2S is small, please do not lose the spacer. CAUTION Clean, disinfect and sterilize the Magnetic sensor attachment and the Spacer for EZU-RV2S before the first use as there are not...

  • Page 19: Magnetic Sensor (Ezu-Rv3S)

    Magnetic Sensor (EZU-RV3S) The Magnetic sensor (EZU-RV3S) as shown in Fig.9 is also applicable for the EUP-C532. Direction mark Magnetic Sensor (white) Fig.9 Magnetic sensor (EZU-RV3S) 4.2.1 How to attach the EZU-RV3S The procedure of attaching the Magnetic sensor is as follows.
  • Page 20 b) Insert the magnetic sensor into the Magnetic sensor attachment with correct direction as shown in Fig.11. Use without the Needle guide bracket Magnetic sensor attachment Direction mark of the Magnetic sensor Magnetic sensor (Place the direction mark upward as shown here.) Fit the insertion direction Projected part of the Magnetic sensor attachment...
  • Page 21 c) Attach the Magnetic sensor attachment to the probe with the correct direction as shown in Fig.12. Use without the Needle Guide Bracket Use with the Needle Guide Bracket Slit of the Projected part of Magnetic sensor the Magnetic sensor attachment attachment Fit the insertion...
  • Page 22 4.2.2 How to release the Magnetic Sensor The procedure of releasing the Magnetic sensor from the probe is as follow. a) Push the Magnetic sensor attachment and release it from the probe as shown in Fig.13 Use without the Needle Guide Bracket Use with the Needle Guide Bracket Push here Push here...
  • Page 23 b) Release the Magnetic sensor from the Magnetic sensor attachment as shown in Fig.14. Use without the Needle guide bracket Use with the Needle guide bracket Fig.14 How to release the magnetic sensor CAUTION Clean, disinfect and sterilize the Magnetic sensor attachment before the first use as there are not sterilize in the factory.

  • Page 24: Reprocessing Procedure

    Reprocessing Procedure The probe and option 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 60°C during reprocessing.
  • Page 25 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, EUP-C532 probe is classified as uncritical. -19- Q1E-EP0416...
  • Page 26 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 Packing Sterilization -20- Q1E-EP0416...

  • Page 27: Point Of Use (Pre-Cleaning)

    5.1 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 28 Prepare the detergent solution in a tank with cold water (please follow the instructions of the detergent manufacturer regarding application, dilution and contact time). A) EUP-C532 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 29 If there is still soil visible, repeat all above steps. Manual disinfection: A) EUP-C532 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).

  • Page 30: Drying

    Magnetic sensor attachment and Spacer for EZU-RV2S 1) Prepare the disinfectant solution as stated in the procedure for the probe. 2) Immerse the Magnetic sensor attachment and the Spacer for EZU-RV2S into the disinfectant (see Fig.15). Set a clock to insure the recommended contact time which is 5 minutes.

  • Page 31: Inspection

    Inspection Inspect the equipment for any damage such as crack, scratch or deformation. Do not use it if any damage is found. Packaging Packaging Pack probe sterile barrier such Polypropylene fleece or transparent package made from Polyethylene film and Tyvek®, and then place it into a tray. The tray should be also covered with a sterile barrier.
  • Page 32 The sterilization method and operating conditions are as follows. Sterilization Method Condition Plasma Sterilization: Short Cycle STERRAD® 50, 100S or 200 (*) Plasma Sterilization: Standard cycle Sterrad® NX or 100NX (*) Gas Type: 10% EO/ 90% HCFC  Temperature: 50-55°C ...

  • Page 33: Storage

    2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig.17 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for sterilization Probe in the Pouch Fig.

  • Page 34: Maintenance And Safety Inspection

    Maintenance and Safety Inspection After using the probe, the Magnetic sensor attachment and the Spacer for EZU-RV2S, it should be cleaned and disinfected or sterilized according to “5. Reprocessing Procedure”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight.

  • Page 35: Safety Precautions

    Safety Precautions WARNING  Never use the probe if the probe head is damaged.  Do not use the latex probe cover for latex sensitive patients. The probe cover, which contains latex, may cause allergic reactions such as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, depression of blood pressure, and shock.

  • Page 36: Specifications

    Specifications Probe Type : EUP-C532 Convex Array Probe Center frequency : 6.5MHz Technology : Convex Array Probe Dimensions : See Fig.19 Weight : Approx. 0.75kg (incl. cable and connector) Scanning angle : 80° Probe materials : Bio-compatible allergy free components...

  • Page 37: Suppliers List

    Suppliers List The products listed below are seriously tested and approved for use with the Convex Array Probe EUP-C532. Product name manufacturer purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incidin Liquid Henkel Hygiene Disinfectant GmbH Incidur Spray...

  • Page 38: Disposal Of The Probe

    Disposal of the probe Recycle or dispose of this equipment properly in compliance with the Waste Management and Public Cleansing Law. CAUTION Before disposing of the equipment, disinfect or take other infection-prevention measures. Disposal of the equipment without taking the proper preventative measures can lead to infection.
  • Page 39 Unit:mm Fig.19 Dimensions -33- Q1E-EP0416...
  • Page 40 Fig.20 External view (with the Magnetic sensor attachment) -34- Q1E-EP0416...
  • Page 41 Fig.21 External view (with the Magnetic sensor attachment and the Needle guide bracket) -35- Q1E-EP0416...

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