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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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Summary of Contents for L34

Page 1: ...L34 Probe INSTRUCTION MANUAL For USA Tokyo Japan Q1E EP1441 2 Hitachi Ltd 2013 2016 All rights reserved DM 120918 v2 ...

Page 2: ... Requirement 10 7 2 Reprocessing Procedure 11 7 3 Cleaning Process 12 7 4 Liquid Chemical Sterilization Disinfection Process 14 7 5 EtO Sterilization Process 15 7 6 Plasma Sterilization Process 16 8 Operating Procedure 17 8 1 Operation of the ultrasound diagnostic scanner 17 8 2 Orientation of the image 18 8 3 Probe Sheath 20 8 4 Diagnosis 20 8 5 Care after use 20 9 Maintenance and Safety Inspecti...

Page 3: ...Probe connector General warning sign Probe connector Warning dangerous voltage Probe connector Caution Biohazard Probe connector Follow the instruction manual to operate this instrument If not avoided may result in injury property damage or the equipment trouble Probe connector STERRAD sterilization compatibility mark Probe connector Do not waste the instrument as general waste Comply with a local...

Page 4: ...ing particular attention to all warnings cautions and notes incorporated herein Please contact a service support if you have any questions concerning the operation of equipment The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning is used to indicate the presence of a hazard which can cause severe personal injury death or substantial pro...

Page 5: ...be caused 5 Do not use chemicals or organic solvents such as thinner for wiping the probe See the paragraph 9 1 Probe Care 6 Do not hit or drop the probe because the inside of the probe head is easily broken by mechanical shocks 7 Keep the probe head off substances containing fatty acid hydrocarbon of methane series paraffin Because it soaks into the inside of the probe head through the surface of...

Page 6: ...ith the FDA Medical Alert report of March 29 1991 titled Allergic Reactions to Latex Containing Medical Devices reprinted on the following pages 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 f...

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Page 9: ...nded use of this probe is limited each device Please contact your local Hitachi representative with any question on this probe availabilities and intended uses Acoustic output Please refer to the Instruction Manual Supplement Safety and Effectiveness of the scanner with which this probe is combined Clinical Measurement Accuracy In case of using measurement function with this probe please refer to ...

Page 10: ...ual 1 copy 3 Case 1 piece Please refer to the instruction manual of option about the method of handling cleaning and sterilizing the coupler attachment EZU PA3C1 5 2 Coupler Attachment EZU PA3C1H The components list of the EZU PA3C1H is given in Table 3 Table 3 Coupler attachment component list Component Note 1 Coupler attachment 2 pieces 2 Needle Guide 2 pieces 3 Instruction manual 1 copy 4 Case ...

Page 11: ...able 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 DM 120918 v2 ...

Page 12: ... Head Connector Cable 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 Fig 1 External view Applied part DM 120918 v2 ...

Page 13: ...e Association for the Advancement of Medical Instrumentation 7 1 Levels of Disinfection Requirement To choose an appropriate disinfectant the user must determine the required level of disinfection based on the following classification See Table 5 and the regulation of each country Table 5 Levels of Disinfection Requirements Classification Definition Levels of disinfection Critical Device directly ...

Page 14: ...rmed even after the probe was used with a probe sheath Do not sterilize the probe by Autoclave Autoclave sterilization causes the probe to malfunction Cleaning Rinsing and Drying after cleaning Rinsing and Drying after sterilization disinfection sterilization disinfection Cleaning Process Liquid chemical sterilization disinfection Process Plasma sterilization Process Fig 2 Reprocessing Procedure E...

Page 15: ...g recommended dilution temperature and soak time Using insufficiently diluted detergent may damage the probe 7 3 2 Rinsing and Drying after Cleaning After cleaning and prior to liquid chemical sterilization high level disinfection the probe must be thoroughly rinsed with deionized running water or sterile water for more than 10 minutes to remove all residue of the detergent solution See Fig 4 Afte...

Page 16: ...441 Fig 3 Immersion of the Probe Water Detergent Disinfectant After Cleaning Sterile Water or deionized running water After Disinfection Liquid chemical sterilization Sterile Water Fig 4 Rinse of L34 DM 120918 v2 ...

Page 17: ...s List following the manufacturer s directions regarding preparation and soak time Fig 3 The contact condition of recommended solutions is given in Table 6 Table 6 Contact condition of sterilant disinfectant Solution Contact condition Purpose Cidex 10 hours at 25 C Sterilization Cidex plus 10 hours at 20 25 C Sterilization Cidex OPA 12 minutes at 20 C Disinfection 1 Do not mix any solution into a ...

Page 18: ...scribe the instruction of EtO sterilizer therefore follow the instructions of your sterilizer regarding the operation 7 5 1 EtO Sterilization Ensure that the probe is cleaned in accordance with the procedure stated in 7 3 Cleaning Process before the sterilization Perform sterilization operations with the condition given in Table 7 Table 7 EtO Sterilization condition Preconditioning none Conditioni...

Page 19: ...ding the operation 7 6 1 STERRAD Sterilization Johnson Johnson Product Ensure that the probe is cleaned in accordance with the procedure stated in 7 3 Cleaning Process before the sterilization Perform sterilization operations by following the instructions of the manufacturer Confirm the sterilization condition before performing sterilization The sterilization by other than the specified condition ...

Page 20: ...rding to the instructions given in the operation manual for the ultrasound diagnostic scanner with which the probe is used as connected Set the ultrasound diagnostic scanner to FREEZE ON mode when replacing the probe Prior to each use ensure that the probe is cleaned and sterilized disinfected in accordance with the procedure stated in 7 2 Reprocessing Procedure CAUTION WARNING DM 120918 v2 ...

Page 21: ...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 Fig 5 Relationship between direction of the probe and Right left orientation Mark Right left orientation mark Index mark DM 120918 v2 ...

Page 22: ...herefore 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 See Fig 6 Fig 6 Wiping out the ultrasound jelly or cleaning the surface of the acoustic lens Acoustic lens Soft cloth or tissue paper CAUTION DM 120918 v2 ...

Page 23: ...a couplant Some Latex material may create allergic reaction See 2 General caution for more detail 8 4 Diagnosis Place the probe on the examination site and adjust the probe s position for a clear view of the desired image 8 5 Care after use Perform the reprocessing procedure in accordance with the procedure stated in 7 2 Reprocessing procedure every time immediately after completing the ultrasound...

Page 24: ...o not use Ethyl alcohol other than cleaning Ethyl alcohol is not effective as a disinfectant sterilant 9 2 Daily Inspection 1 Visually inspect the surface of the probe head the housing and the cable for any crack scratch or denaturalization If you find damage do not use the probe and immediately contact our service personnel 2 Visually inspect the ultrasound image for abnormality or major change f...

Page 25: ...r detailed information contact a service support Cleaning Applicable detergents are listed in the suppliers list Disinfection Applicable disinfectants are listed in the suppliers list Sterilization ETO gas sterilization Plasma sterilization Operating conditions Ambient temperature 10 35 C Contact surface temperature max 42 C Temperature of examinee Relative humidity 30 85 subject to no condensatio...

Page 26: ...ex Plus Johnson Johnson Sterilant Cidex OPA Johnson Johnson disinfectant Transducer covers CIVCO Medical Covers 12 Disposal of the probe Recycle or dispose of equipment properly in compliance with your organizational rules and your local laws Before disposing of the equipment disinfect or take other infection prevention measures Disposal of the equipment without taking the proper preventative meas...

Page 27: ... 24 Q1E EP1441 Unit mm Fig 7 Dimensions DM 120918 v2 ...

Page 28: ... 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 E DM 120918 v2 ...

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