Related Manuals for Hitachi L34
Summary of Contents for Hitachi L34
- Page 1 L34 Probe INSTRUCTION MANUAL --- For USA --- Tokyo , Japan Q1E-EP1441-2 ©Hitachi, Ltd. 2013,2016. All rights reserved. DM 120918 v2...
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Page 2: Table Of Contents
Coupler Attachment EZU-PA3C1 ......7 Coupler Attachment EZU-PA3C1H ......7 Coupler Attachment EZU-PA3C2 ......8 External View ..........9 Cleaning and sterilization/ high level disinfection of L34 .......10 Levels of Disinfection Requirement .....10 Reprocessing Procedure .........11 Cleaning Process ........12 Liquid Chemical Sterilization/Disinfection Process ..14 EtO Sterilization Process ......15... - Page 3 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 6.
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Page 4: Foreword
Foreword Before using the probe, carefully read this instruction manual for correct and safe handling of the probe as well as for making the most of the performances of the probe and the ultrasound scanner with which the probe is to be used. Notes to Users To ensure safe operation, it is essential that you fully understand the function, operating and maintenance instructions by thoroughly... -
Page 5: General Caution
The warranty period of the probes is one year from their delivery to the user. If they become faulty within this period and it is evident that Hitachi is responsible for the fault, they will be repaired or replaced with normal ones free of charge. - Page 6 In certain applications, the use of a protective sheath is recommended. Because of the possibility of latex-sensitive patients, Hitachi and HAMA are now recommending the use of non-latex covers. Specifically, we are recommending that the end user utilize the following devices:...
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Page 9: General
General L34 Probe is of linear array type. This is designed for use as connected with Hitachi Ultrasound scanner. Clinical Intended Use Please refer to the Instruction Manual (Supplement – Safety and Effectiveness) of the scanner with which this probe is combined. -
Page 10: Probe Components List
Probe Components List The components list of L34 is given in Table.1. Table.1 Probe component list Component Note 1 L34 Probe 1 piece 2 Instruction manual 1 copy 3 Shipping & storage box 1 set Accessories (Option) Coupler Attachment EZU-PA3C1 The components list of the EZU-PA3C1 is given in Table.2. -
Page 11: Coupler Attachment Ezu-Pa3C2
Coupler Attachment EZU-PA3C2 The components list of the EZU-PA3C2 is given in Table.4. Table.4 Coupler attachment component list Component Note 1 Coupler attachment 2 pieces 2 Immobilizing band 2 pieces 3 Instruction manual 1 copy 4 Case 1 piece Please refer to the instruction manual of option about the method of handling, cleaning and sterilizing the coupler attachment EZU-PA3C2. -
Page 12: External View
External View The external view of L34 probe is given in Fig.1. Immersible part (IPX7) Cable Head Applied part Connector Un-immersible part Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water. Un-immersible part: This part should not be immersed in disinfectant solution and also can not be cleaned by water. -
Page 13: Cleaning And Sterilization/High Level Disinfection Of L34
Cleaning and sterilization/high level disinfection of L34 The probe is not sterilized, but must be sterilized or disinfected before initial use, and after each subsequent use, following the directions given below and working in accordance with standard hospital practice. (For reference, consult “Good Hospital Practice: Handling and Biological Decontamination of Reusable Medical Devices: ANSI/AAMI ST35-1991”, published by the Association for the... -
Page 14: Reprocessing Procedure
Reprocessing Procedure After each use of the probe, the reprocessing procedure including cleaning, disinfection, and sterilization must be performed immediately. A flow diagram showing the steps of the reprocessing procedure is given in Fig.2. The reprocessing procedure must be performed even after the probe was used with a probe sheath. Cleaning Process Cleaning Rinsing and Drying... -
Page 15: Cleaning Process
Cleaning Process Prior to liquid chemical sterilization/high level disinfection process, the probe must be cleaned. 7.3.1 Cleaning ® Immerse the probe in an enzymatic detergent (Enzol solution (as shown in Fig. 3) for more than 30 minutes or until the visible residue is removed. If needed, scrub the probe using a soft sponge, gauze, or cloth to remove visible residue from the surface of the probe. - Page 16 Water Detergent Disinfectant Fig.3 Immersion of the Probe After Cleaning: Sterile Water or deionized running water After Disinfection/Liquid chemical sterilization: Sterile Water Fig.4 Rinse of L34 DM 120918 v2 - 13 - Q1E-EP1441...
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Page 17: Liquid Chemical Sterilization/Disinfection Process
Liquid Chemical Sterilization/Disinfection Process For sterilization/high level disinfection of L34 using liquid chemicals, follow the procedures as indicated in this section. (For reference, consult “Chemical Sterilants and sterilization Methods - A Guide to Selection and Use: AAMI TIR7-113”, published by the Association for the Advancement of Medical Instrumentation). -
Page 18: Eto Sterilization Process
(2) The probe connector is not waterproof. Do not allow liquid to contact the connector. EtO Sterilization Process L34 is compatible with Ethylene Oxide (EtO) Sterilization. This manual does not describe the instruction of EtO sterilizer, therefore, follow the instructions of your sterilizer regarding the operation. -
Page 19: Plasma Sterilization Process
Plasma Sterilization Process ® ® L34 is compatible with STERRAD Plasma Sterilization (STERRAD 50,100S and 200). This manual does not describe the instructions ® of STERRAD system, therefore, follow the instructions of your ® STERRAD system regarding the operation. ®... -
Page 20: Operating Procedure
Operating Procedure Operation of the ultrasound diagnostic scanner 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. WARNING Set the ultrasound diagnostic scanner to “FREEZE ON”... -
Page 21: Orientation Of The Image
Orientation of the image The Relationship between the direction of the probe and the B-Mode image is shown in Fig.5. The mark of right-left orientation on the image indicates the direction of the index mark of the probe. (For detail of the right-left orientation mark, refer to the instruction manual of the device to be connected.) Index mark... - Page 22 CAUTION The acoustic lens of the probe is manufactured very thin and delicate to get the high resolution. Therefore, in case of wiping out the ultrasound jelly or cleaning the surface of the acoustic lens, please use the soft cloth or tissue paper and handle with care.
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Page 23: Probe Sheath
Probe Sheath Use a sterile probe sheath to protect the probe. The probe sheath should be allergy free material to avoid allergic reaction. Between the probe and the probe sheath, acoustic coupling gel is required as a couplant. WARNING Some Latex material may create allergic reaction. See “2. -
Page 24: Maintenance And Safety Inspection
Maintenance and Safety Inspection Probe Care Use gauze soaked in water or in ethyl alcohol to clean the dirt on the surface of the probe. CAUTION (1) Do not attempt to scrape away caked dust on the probe with a hard cloth or knife. -
Page 25: Specifications
10. Specifications Type : L34 Probe Acoustic working Frequency : 5.0MHz Technology : Linear Array Probe Dimensions : See Fig.7 Weight : Approx. 0.44kg (Including cable and connector) Probe materials : Biocompatible allergy free components Applicable systems : Depending on production and upgrade status for detailed information, contact a service support. -
Page 26: Supplier's List
11. Supplier’s List The products listed bellow are seriously tested and approved for use with the linear array probe L34. Product name manufacturer purpose ® Enzol Johnson & Johnson Enzymatic detergent ® Cidex Johnson & Johnson Sterilant ® Cidex Plus Johnson &... - Page 27 Unit:mm Fig.7 Dimensions DM 120918 v2 - 24 - Q1E-EP1441...
- Page 28 Manufacturer Hitachi,Ltd. 2-16-1, Higashi-Ueno,Taito-ku,Tokyo,110-0015,Japan Contact +81-3-6284-3668 http://www.hitachi.com/businesses/healthcare/index.html Representative Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard, Wallingford, CT 06492 U.S.A. DM 120918 v2 - 25 - Q1E-EP1441...
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