73 Pages
Preview
Page 1
Ultrasonic Transducer
Operator’s Manual
Contents Contents ...i 1
Overview ... 1-1 1.1 1.2 1.3 1.4 1.5 1.6
2
Connecting the Transducer to the System ... 2-1 2.1
3
Check the External Appearance of the Transducer ... 3-1 Cleaning the Transducer ... 3-1 Checking after Turning on the System ... 3-1
Operating Procedures ... 4-1 4.1 4.2 4.3 4.4 4.5
5
Connecting and Disconnecting the Transducer ... 2-1
Inspection Before and After Use ... 3-1 3.1 3.2 3.3
4
Safety Classification ... 1-1 Applications ... 1-1 Acoustic Power... 1-1 Transducer/Needle-guided Bracket Model... 1-1 Composition ... 1-19 Procedures for Operating the Transducer ... 1-24
Orientation of the Ultrasound Image and the Transducer Head ... 4-1 Utilizing the Transducer Sheath ... 4-2 When the Immersion Method is Used ... 4-3 Examinations ... 4-7 After Examinations ... 4-7
Cleaning and Disinfection... 5-1 5.1 5.2 5.3
Cleaning ... 5-1 High Level Disinfections ... 5-2 Sterilization ... 5-5
6
Needle-guided Bracket and Biopsy ... 6-1
7
Storage and Transportation ... 7-1
8
Specifications ... 8-1
i
© 2010-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is 2016-04.
Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. ,
,
,
,
,
BeneView,
WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: z z z
all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; the electrical installation of the relevant room complies with the applicable national and local requirements; and the product is used in accordance with the instructions for use.
Note This equipment must be operated by skilled/trained clinical professionals.
Warning It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.
I
Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
II
Company Contact Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057,P.R.China
Website:
www.mindray.com
E-mail Address:
Tel:
+86 755 81888998
Fax:
+86 755 26582680
EC-Representative:
Shanghai International Holding Corp. GmbH(Europe)
Address:
Eiffestraβe 80, Hamburg 20537, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
Manufacturer:
Mindray DS USA, Inc.
Address:
800 MacArthur Blvd. Mahwah, NJ 07430-0619 USA
Tel:
+1(201) 995-8000
Toll Free:
+1 (800) 288-2121
Fax:
+1 (800) 926-4275
III
Important Information Responsibility on customers: 1. The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product. 2. The warranty does not cover the following items, even during the warranty period: (1) Damage or loss due to misuse or abuse. (2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc. (3) Damage or loss caused by failure to meet the specified conditions for this system, such as inadequate power supply, improper installation or environmental conditions. (4) Damage or loss due to use of the system outside the region where the system was originally sold. (5) Damage or loss involving the system purchased from a source other than Mindray or its authorized agents. 3. This equipment shall not be used by persons other than fully qualified and certified medical personnel. 4. Do not make changes or modifications to the software or hardware of this product. 5. In no event shall MINDRAY be liable for problems, damage, or loss caused by relocation, modification, or repair performed by personnel other than those designated by MINDRAY. 6. The purpose of this system is to provide physicians with data for clinical diagnosis. The responsibility for diagnostic procedures lies with the physicians involved. MINDRAY shall not be liable for the results of diagnostic procedures. 7. MINDRAY shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents. 8. This manual contains Warnings regarding foreseeable potential dangers. Be alert at all times to dangers other than those indicated. MINDRAY shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions contained in this operator’s manual. 9. On the occasion of change of the administrator or manager for this system, be sure to hand over this operator’s manual. 10. When disposing of this system, contact your MINDRAY Customer Service Department or sales representative. Do not dispose of this system without consulting MINDRAY Customer Service Department or sales representative first. MINDRAY does not assume any responsibility for damage resulting from disposal of this system without consulting MINDRAY.
IV
Introduction This operator’s manual describes the operating procedure for the transducers. To ensure safe and correct operation of the transducer, read the operator’s manual carefully and understand the transducers clearly before operation. For the operating procedures for the ultrasonic diagnostic system and other devices, please refer to the relevant manuals.
V
Safety Precautions Meaning of Signal Words In this operator’s manual, DANGER, WARNING, CAUTION and NOTE are signal words used to indicate safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual. Signal Word
Meaning
DANGER
Indicates an imminently hazardous situation that, if not avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury.
NOTE
Indicates a potentially hazardous situation that, if not avoided, may result in property damage.
Meaning of Safety Symbols Description
Symbol
General warning, caution, risk of danger.
Safety Precautions Please read the following precautions carefully to ensure the safety of the patient and the operator when using this transducer.
DANGER:
DO NOT use flammable gasses, such as anesthetic gas or hydrogen, or flammable liquids such as ethanol, near the product, because there is danger of explosion.
WARNING:
1. Confirm that the transducer and cable are normal before and after each examination. A defective transducer may cause electric shock to the patient. 2. Do not subject the transducer to shock. A defective transducer may cause electric shock to the patient.
VI
3. Do not disassemble the transducer to avoid the possibility of electric shock. 4. Never immerse the transducer connector into liquids such as water or disinfectant because the connector is not waterproof. Immersion may cause electric shock or malfunction. 5. The ultrasonic transducer is only for use with the specified ultrasonic diagnostic system. Please refer the ultrasonic diagnostic system operation manual to select the proper transducer. 6. A transducer sheath must be installed over the transducer before performing examination. 7. Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case.
CAUTION:
1. When using the transducer, wear sterile gloves to prevent infection. 2. Be sure to use ultrasound gel. Please use the ultrasound gel compliant with the relevant local regulations. 3. In normal diagnostic ultrasound mode, there is no danger of a low-temperature burn; however, keeping the transducer on the same region of the patient for a long time may cause such a burn. 4. Do not use the carrying case for storing the transducer. If the carrying case is used for storage, it may become a source of infection. 5. The transducer and accessories supplied with it are not delivered disinfected or sterilized. Sterilization (or highlevel disinfect) before use is required. 6. It is required to practice ALARA when operating ultrasound system. Minimize the acoustic power without compromising the quality of images. 7. Disposable components are packaged sterile and are single-use only. Do not use if integrity of packaging violated or if expiration date has passed. Please use the disposable components compliant with the relevant local regulations. 8. Please use the disinfection or sterilization solution that recommended in this operator’s manual, otherwise Mindray will not be liable for damage caused by other solutions. If you have any questions, please contact Mindray Customer Service Department or sales representative. 9. Do not use pre-lubricated condoms as a sheath. Lubricant may not be compatible with the transducer material and damage may result.
VII
10. Transducer damage may be caused by inappropriate gel, detergent or cleanser: Do not soak or saturate transducers with solutions containing alcohol, bleach, ammonium chloride compounds, acetone or formaldehyde. Avoid contact with solutions or coupling gels containing mineral oil or lanolin.
NOTE:
1. Read the following precautions to prevent the transducer from malfunction. z z
Before connecting or disconnecting the transducer, freeze or turn off the ultrasonic diagnostic system. Clean and disinfect the transducer before and after each examination.
2. Ambient conditions: To prevent the transducer from being damaged, do not use it where it will be exposed to: z direct sunlight or X-rays z sudden changes in temperature z dust z excessive vibration z heat generators Use the transducer under the specified ambient conditions, for details; please refer to “8 Specifications”.
3. Repeated disinfection will eventually damage the transducer, please check the transducer’s performance periodically.
VIII
Labels Various labels are attached to the device in order to call the user's attention. This operator’s manual describes the safety precautions of operating the transducer. Read the operator’s manual carefully before using the system. Some labels are shown in the following. No. 1
Label
Meaning Indicates the direction of the lock handle. The top symbol indicates the position of locked handle, the left symbol indicates the position of the unlocked handle. This label is found on Doppler ultrasound system transducers and on black and white ultrasound 128-element transducers.
2
Indicates the direction of the lock handle. The left symbol indicates the position of the unlocked status; the right symbol indicates the position of the locked status. . This label is found on black and white ultrasound 80-element transducers.
3
Type-BF applied part.
4
General warning sign.
IX
1
Overview
1.1 Safety Classification Please refer to the safety classification information in the related operator’s manual for the ultrasonic diagnostic system that matches with the transducer.
1.2 Applications Please check the operator’s manual for the ultrasonic diagnostic system to check the compatibility of the transducer. For the intended use, please refer to the operator's manuals of the corresponding diagnostic ultrasound system.
1.3 Acoustic Power The effects of acoustic power on human tissue are currently under investigation. Therefore, it is recommended that diagnostic ultrasound output power be set to the lowest possible levels in accordance with the ALARA (As Low As Reasonably Achievable) principle. Please refer to the operator’s manual of the ultrasonic diagnostic system.
1.4
Transducer/Needle-guided Bracket Model
1.4.1
Transducer Model
No.
Model
Type
Applied region
1.
35C50EB
Convex
Body surface
1-1
Illustration
Overview No.
Model
Type
Applied region
2.
35C50P
Convex
Body surface
3.
65EC10EB
Convex (intracavitary)
Transrectal, transvaginal
4.
75L38EB
Linear
Body surface
5.
75L38P
Linear
Body surface
6.
65C15EA
Convex
Body surface
7.
75L60EA
Linear
Body surface
8.
35C20EA
Convex
Body surface
1-2
Illustration
Overview No.
Model
Type
Applied region
9.
65C15EAV
Convex
Body surface
10.
75L50EAV
Linear
Transrectal
11.
50L60EAV
Linear
Transrectal
12.
35C50EA
Convex
Body surface
13.
65EC10EA
Convex (intracavitary)
Transrectal, transvaginal
14.
75L38EA
Linear
Body surface
15.
65EL60EA
Linear (transrectal)
Transrectal
1-3
Illustration
Overview No.
Model
Type
Applied region
16.
75L53EA
Linear
Body surface
17.
75LT38EA
Linear
Intraoperative
18.
35C50HA
Convex
Body surface
19.
35C20HA
Convex
Body surface
20.
65EC10HA
Convex (intracavitary)
Transrectal, transvaginal
21.
65C15HA
Convex
Body surface
22.
75L38HA
Linear
Body surface
23.
75L38HB
Linear
Body surface
1-4
Illustration
Overview No.
Model
Type
Applied region
24.
75L60HB
Linear
Body surface
25.
65EC10EC
Convex (intracavitary)
Transvaginal
26.
65EC10ED
Convex (intracavitary)
Transvaginal
27.
65L50HAV
Linear
Transrectal
28.
65EL66HA
Linear (transrectal)
Transrectal
29.
75LT40HA
Linear
Intraoperative
30.
75L53HA
Linear
Body surface
1-5
Illustration
Overview No.
Model
Type
Applied region
31.
65EC10HC
Convex (intracavitary)
Transvaginal
32.
65EC10HD
Convex (intracavitary)
Transvaginal
33.
6LE5V/6LE5 Vs
Linear
Transrectal
Linear (transrectal)
Transrectal
6LE7/ 34.
6LE7s/ 6LE7P
35.
6LB7/6LB7s
Biplanar
Transrectal
36.
10L4/10L4s
Linear
Body surface
37.
7L4/7L4s
Linear
Body surface
1-6
Illustration
Overview No.
Model
Type
Applied region
38.
7L6/7L6s
Linear
Body surface
39.
6CV1/6CV1 s/6CV1P
Convex (intracavitary)
Transrectal, transvaginal
40.
3C1/3C1s
Convex
Body surface
41.
3C5/3C5s
Convex
Body surface
42.
3C5A/3C5P
Convex
Body surface
43.
C5-2/C5-2s
Convex
Body surface
44.
V10-4/10-4s
Convex
Transvaginal
1-7
Illustration
Overview No.
Model
Type
Applied region
Convex
Transvaginal
Convex
Body surface
V10-4B/ 45.
V10-4Bs/ V10-4BP
6C2/ 46.
6C2s/ 6C2P
47.
7L4A/7L4P
Linear
Body surface
48.
L11-4/L114s
Linear
Body surface
49.
L12-4/L124s
Linear
Body surface
50.
L7-3/L7-3s
Linear
Body surface
51.
L14-6/L146s/L14-6P
Linear
Body surface
1-8
Illustration
Overview No.
Model
Type
Applied region
52.
7L5/7L5s /7L5P
Linear
Body surface
53.
65EB10EA
Bi-plane (convex)
Transrectal
54.
10L24EA
Linear
Body surface
Phased
Body surface
Phased
Body surface
Phased
Body surface
2P2/ 55.
2P2s/ 2P2P
56.
57.
P7-3/P73s/P7-3E
P12-4/ P12-4s
1-9
Illustration