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C25 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-EP1379-5
© Hitachi, Ltd. 2013,2017. All rights reserved
0123
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Summary of Contents for Hitachi C25
- 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-EP1379-5 © 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-EP1379...
- Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, disinfecting and/or sterilizing the Hitachi ultrasound probes. It also describes safety considerations, maintenance. For instructions for operating the main unit, refer to the operation manual for it. Before using the probe, thoroughly read this manual and keep this book for future reference.
- 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 1.6.
- Page 6 CONTENTS Page General ............1 1.1 General ............. 1 1.2 Principles of operation ..........1 1.3 Intended Use ............2 1.4 Components ............2 1.5 Option .............. 3 1.6 ...
- Page 7 General General C25 Probe is a Convex Array Probe. The acoustic output of C25 Probe 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 C25 Probe is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner. General abdominal organs Biopsy (with Needle guide bracket) WARNING Never use the probe for following applications.
- Page 9 Option 1.5.1 Needle Guide Bracket EZU-PA7C1 Needle guide bracket········ 1 piece Brush······················· 1 piece Spring(Spare)··············· 2 pieces Instruction manual·········· 1 copy Case························ 1 piece Please refer to the instruction manual of needle guide bracket EZU-PA7C1 about the method of handling, cleaning, disinfecting and sterilizing the needle guide bracket EZU-PA7C1.
- Page 10 External View The external view of C25 Probe is shown in Fig. 1. Immersible part (IPX7) Head Applied part Cable Connector Un-immersible part Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water.
- Page 11 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. 2.1.2 Do not attach or connect unauthorized devices or instruments on the probe, such as unauthorized biopsy attachments.
- Page 12 Operation Procedure Confirm that the probe is cleaned, disinfected or sterilized. 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. Confirm the direction of the probe.
- Page 13 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 desire image.
- Page 14 The probe should be packed in a sterile pouch or container to transport from Central Sterile Supply Transportation Department (CSSD) to an operating room. Be careful not before using to damage the sterile pouch or container during transportation. According to the intended use, EUP-C25 is classified as uncritical. Q1E-EP1379...
- Page 15 Levels of reprocessing requirements: Depending on the application of the product and with regard to risk evaluation, the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as uncritical, semi-critical or critical. Supporting information concerning this topic is listed in the table below.
- Page 16 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 -10- Q1E-EP1379...
- Page 17 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 18 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 19 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 20 Drying Drying 1) Wipe the equipment 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 60°C.
- Page 21 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 22 2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 5 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for sterilization Probe in the Pouch Fig.
- Page 23 Maintenance and Safety Inspection After using the probe, the probe should be cleaned and disinfected or sterilized according to “4. Reprocessing Procedure”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight. Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization.
- Page 24 Safety Precautions WARNING Never use the probe if the probe head is damaged. Warning is case of using probe covers which latex is contained to. The latex may cause such allergic reactions as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, and depression of blood pressure, shock and so on.
- Page 25 Specifications Probe Type : C25 Probe Acoustic working frequency : 3.5MHz Technology : Convex Array Probe Dimensions : See Fig. 7 Weight : Approx. 0.49kg (incl. cable and connector) Scanning angle : 70° Probe materials : Bio-compatible allergy free components...
- Page 26 Suppliers List The products listed below are seriously tested and approved for use with C25 Probe. Product name manufacturer purpose ® Cidezyme Johnson & Johnson Enzymatic detergent STERANIOS 2% ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant CIDEX Johnson & Johnson Disinfectant ®...
- Page 27 Unit:mm Fig. 7 Dimensions -21- Q1E-EP1379...
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