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: ( 1 ) Q1E-EP1370...
About this manual This instruction manual shall provide instructions for using, cleaning, and disinfecting and/or sterilizing the HITACHI ultrasound probes. It also describes safety considerations, maintenance. For instructions for operating the ultrasound diagnostic scanner, refer to the operation manual for it.
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...
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 1.6.
Introduction 1.1 General L44 Probe is a linear array probe. The acoustic output of L44 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.
1.3 Intended Use L44 Probe is designed for observation and diagnosis mainly of the following regions by connecting with the Hitachi ultrasound diagnostic scanner. Superficial region Cervical region Mammary gland Biopsy (with Coupler Attachment) WARNING Never use the probe for following applications.
1.5 Option 1.4.1 Elasto coupler (Part number: 7225446A) 1.4.2 Coupler Attachment EZU-PA7L1 Coupler attachment ········ 2 pieces Needle Guide (18G) ········ 2 pieces The needle of 20 to 22 gauge fits in the Needle guide (18G). The diameter of a needle and its corresponding gauge size is different for manufactures.
1.6 External View The external view of L44 Probe is shown in Fig. 1. Immersible part (IPX7) Head Applied part Cable Elasto coupler (Option) Connector Un-immersible part 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. 2.1 Inspection of appropriate connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner.
Operation Procedure 1) Confirm that the probe and the elasto coupler are cleaned and 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.
4) Using a sterile probe cover to protect the probe is recommended. 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 desired image.
Option of L44 Probe 4.1 Elasto Coupler 4.1.1 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. 3.
Reprocessing Procedure The probe must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. For reprocessing of the oupler attachment EZU-PA7L1 and needle guide refer to the instruction manual of EZU-PA7L1. ‐ The probe is delivered unsterile. Prior to the first use, reprocess the probe.
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.
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 ( 11 ) Q1E-EP1370...
Pre-cleaning should be done immediately after each use. The procedure is as follows: (Pre-cleaning) A) L44 probe 1) Remove the probe cover and any accessories from the probe. 2) Clean the probe of all patient’s blood or fluid with running tap water until the surface of the probe looks visually clean.
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) L44 probe 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.
Manual disinfection: A) L44 probe 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.
Water Detergent Disinfectant Fig. 5 Immersion of the probe and the elasto coupler ( 15 ) Q1E-EP1370...
Drying 5.4 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.
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 Pouch sealer. Ensure that the seal is Sealed complete. Fig. 7 Sealing 3) Put the sealed pouch into a tray or Tray for plastic mesh wire for sterilization sterilization. Probe in the Pouch Fig.
Maintenance and Safety Inspection 1) After using the probe and the elasto coupler, it should be cleaned and disinfected or sterilized following “5. Reprocessing Procedure”, then store it in a cool and dark place avoid high temperature and humidity, direct sunlight. Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization.
Safety Precautions WARNING Never use the probe if the probe 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.
8.2 Suppliers List The products listed below are seriously tested and approved for use with the Linear Array Probe L44. Product name manufacturer purpose Cidezyme® Johnson & Johnson Enzymatic detergent STERANIOS 2% ANIOS Disinfectant ANIOXYDE1000 ANIOS Disinfectant CIDEX Johnson & Johnson Disinfectant CIDEX®...