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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-EP1041...
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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.
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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 Medical Device Probe connector and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.6.
General General The EUP-L74M is a Linear Array Probe. The acoustic output of the EUP-L74M 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.
Never use the probe for following applications. Direct contact to the heart. Biopsy to the heart. Components The components of the EUP-L74M are given below: 1) Probe EUP-L74M ......1 piece 2) Instruction manual ....1 copy CAUTION Sterilization has not been made to the probe, shipped from the factory.
External View The external view of the EUP-L74M is shown in Fig. 1. Immersible part (IPX7) Cable Head Applied part Connector Elasto coupler (Option) Magnetic sensor attachment (Option) Spacer for EZU-RV2S (Option) Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water.
Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. Inspection of 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.
Operation Procedure 1) Confirm that the probe, the magnetic sensor attachment, the spacer for EZU-RV2S and the elasto coupler are cleaned, disinfected or sterilized. 2) 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.
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4) 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. 5) Place the probe on the examination site and adjust the probe’s position for a clear view of the desire image.
EZU-RV3S. The magnetic sensors EZU-RV2S and EZU-RV3S are shown in Fig. and Fig. The use of the EUP-L74M with either one of the magnetic sensors enables the user to perform RVS (Real-time Virtual Sonography). Magnetic sensor EZU-RV2S The magnetic sensor EZU-RV2S is shown in Fig. 3.
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4.1.1 How to attach the Magnetic sensor The procedure of attaching the magnetic sensor is as follows. 1) Attach the spacer for EZU-RV2S to the magnetic sensor. 2) Insert the magnetic sensor into the magnetic sensor attachment with the correct direction as shown in Fig. 4. 3) Place the magnetic sensor attachment in the index mark of the probe.
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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. 4.1.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor from the probe is as follows.
CAUTION The spacer for EZU-RV2S is small, please do not lose the spacer. Magnetic sensor EZU-RV3S The EZU-RV3S is shown in Fig. 7. Direction mark Sensor (white) Fig. 7 Magnetic sensor EZU-RV3S 4.2.1 How to attach the Magnetic sensor The procedure of attaching the magnetic sensor is as follows. 1) Attach the magnetic sensor into the probe with the correct direction as shown in Fig.
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Projected part of the Magnetic sensor attachment Fit the insertion direction Index mark Fig. 9 How to attach the Magnetic sensor attachment CAUTION Never attach the magnetic sensor attachment to the probe in the incorrect direction, otherwise it may result in false diagnosis. -11- Q1E-EP1041...
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4.2.2 How to release the Magnetic sensor The procedure of releasing the magnetic sensor from the probe is as follows. 1) Turn around the magnetic sensor attachment and release it from the probe as shown in Fig. 10. Fig. 10 How to release the Magnetic sensor attachment from the probe 2) Release the magnetic sensor from the magnetic sensor attachment as shown in Fig.
Elasto Coupler 4.3.1 How to attach the Elasto Coupler To use elastography, attach the elasto coupler as shown below. Attach the elasto coupler on the probe as straight as possible as shown in Fig. 12. Elasto coupler Fig. 12 How to attach the Elasto coupler 4.3.2 How to release the Elasto Coupler Release the elasto coupler from the probe as shown in Fig.
Reprocessing Procedure The probe, magnetic sensor attachment and spacer for EZU-RV2S must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. Please refer to the instruction manual of option EZU-PA7L2 about the method of handling, cleaning and sterilizing the EZU-PA7L2 ‐...
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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-L74M probe is classified as uncritical. -15- Q1E-EP1041...
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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 Packing Sterilization -16- Q1E-EP1041...
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.
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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-L74M 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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If there is still soil visible, repeat all above steps. Manual disinfection: A) EUP-L74M 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).
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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. 14). Set a clock to insure the recommended contact time which is 5 minutes.
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.
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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 ...
2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 16 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for sterilization Probe in the Pouch Fig.
Maintenance and Safety Inspection After using the probe, the probe should be cleaned and disinfected and/or sterilized according to “5. Reprocessing Procedure”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight. After using the magnetic sensor attachment, the spacer for EZU-RV2S and the elasto coupler, it should be cleaned and disinfected and/or sterilized according to “5.
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.
Suppliers List The products listed below are seriously tested and approved for use with the Linear Array Probe EUP-L74M. Product name manufacturer purpose Cidezyme Johnson & Johnson Enzymatic detergent Meliseptol HBV-Tücher Braun Disinfectant Incides Henkel Hygiene Disinfectant GmbH Incidin Liquid...
Disposal of the probe Recycle or dispose the equipment properly in compliance with your organizational rules and your local laws. 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.