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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-EP1272...
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About this manual This instruction manual shall provide the procedure for inspection, operation, and reprocessing of the EUP-CV724. The manual also contains the general information and the specification of the probe. The probe is usable with the HITACHI ultrasound diagnostic scanner.
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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...
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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 Probe connector Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.5.
1. Introduction 1.1 General The model EUP-CV724 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.
Hitachi ultrasound diagnostic scanner. Hitachi service engineer installs the CD-ROM to the scanner. Store the CD-ROM in a safe place. 1.5 External View The external view of the EUP-CV724 is given in Fig. 1. Un-immersible Immersible part part (IPX7)
2. Inspection procedure Prior to each use, the probe must be carefully inspected as indicated below. (1) Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization. (2) Confirm that neither unauthorized devices nor instruments such as unauthorized biopsy attachments are attached to the probe.
3. Operation Procedure (1) Confirm that the probe is disinfected. (2) Cover the probe with a disposal probe cover to protect the probe. The probe cover should be allergy free material to avoid allergic reaction. Apply acoustic coupling gel inside and outside of the probe cover.
Application part contacts Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Application part contacts Disinfection intracorporeal tissue (Disinfectant with critical directly (operative virucidal effect - application) minimum) Sterilization According to the intended use, EUP-CV724 probe is classified as uncritical. Q1E-EP1272...
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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-EP1272...
Point of use (Pre-cleaning) Pre-cleaning should be done immediately after each use. Point of use Point of use (Pre-cleaning) (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.
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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.
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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.
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 40°C.
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 non-sterile acoustic coupling gel.
7.2 Suppliers List The products listed below are seriously tested and approved for use with the EUP-CV724. Product name Manufacturer Purpose Alkazyme ALKAPHARM Cleaner Klenzyme KLENZYME Cleaner ENZOL® Johnson & Johnson Cleaner Steranios 2% Laboratoires ANIOS High-level Disinfectant CIDEX® Johnson & Johnson High-level Disinfectant CIDEX®...
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2300 Unit: mm Fig. 4 Dimension diagram of EUP-CV724 -14- Q1E-EP1272...
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