Mindray 35C50EB User manual

Ultrasonic Transducer
Operator’s Manual

i
Contents
Contents ............................................................................................................................... i
1 Overview .................................................................................................................... 1-1
1.1 Safety Classification ............................................................................................................. 1-1
1.2 Applications .......................................................................................................................... 1-1
1.3 Acoustic Power ..................................................................................................................... 1-1
1.4 Transducer/Needle-guided racket Model ........................................................................... 1-1
1.5 Composition ....................................................................................................................... 1-21
1.6 Procedures for Operating the Transducer ......................................................................... 1-26
2 Connecting the Transducer to the System .............................................................. 2-1
2.1 Connecting and Disconnecting the Transducer ................................................................... 2-1
Inspection Before and After Use .............................................................................. -1
3.1 Check the External Appearance of the Transducer ............................................................. 3-1
3.2 Cleaning the Transducer ...................................................................................................... 3-1
3.3 Checking after Turning on the System ................................................................................. 3-1
4 Operating Procedures .............................................................................................. 4-1
4.1 Orientation of the Ultrasound Image and the Transducer Head .......................................... 4-1
4.2 Utilizing the Transducer Sheath ........................................................................................... 4-2
4.3 When the Immersion Method is Used .................................................................................. 4-3
4.4 Examinations ........................................................................................................................ 4-7
4.5 After Examinations ............................................................................................................... 4-7
5 Cleaning and Disinfection ........................................................................................ 5-1
5.1 Cleaning ............................................................................................................................... 5-1
5.2 High Level Disinfections ....................................................................................................... 5-2
5.3 Sterilization ........................................................................................................................... 5-3
6 Needle-guided Bracket and Biopsy ......................................................................... 6-1
7 Storage and Transportation ..................................................................................... 7-1
8 Specifications ........................................................................................................... 8-1

I
© 2010-2017 Shenzhen Mindray io-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2017-09.
Intellectual Property Statement
SHENZHEN MINDRAY IO-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.
, , , , , eneView,
WATO, eneHeart, 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:
 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.

II
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTA ILITY 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.

III
Company Contact
Manufacturer: Shenzhen Mindray io-Medical Electronics Co., Ltd.
Address: Mindray uilding, Keji 12th Road South, High-tech industrial
park, Nanshan, Shenzhen 518057,P.R.China
Website:
www.mindray.com
E-mail
Address:
[email protected]
Tel:
[phone]
Fax:
[phone]
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: [phone]
Fax: [phone]
Manufacturer: Mindray DS USA, Inc.
Address: 800 MacArthur lvd.
Mahwah, NJ 07430-0619 USA
Tel: [phone]
Toll Free: [phone]
Fax: [phone]

IV
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. e 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.

V
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.

VI
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
Symbol
Description
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.

VII
. 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.
. 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 high-
level 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.

VIII
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.
 efore 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:
 direct sunlight or X-rays
 sudden changes in temperature
 dust
 excessive vibration
 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.

IX
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. Label Meaning
1 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- F applied part.
4 General warning sign.

1-1
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. 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 Illustration
1. 35C50E Convex ody surface

Overview
1-2
No. Model Type Applied
region Illustration
2. 35C50P Convex ody surface
3. 65EC10E
Convex
(intracavitary)
Transrectal,
transvaginal
4. 75L38E Linear ody surface
5. 75L38P Linear ody surface
6. 65C15EA Convex ody surface
7. 75L60EA Linear ody surface
8. 35C20EA Convex ody surface

Overview
1-3
No. Model Type Applied
region Illustration
9. 65C15EAV Convex ody surface
10. 75L50EAV Linear
Transrectal
11. 50L60EAV Linear Transrectal
12. 35C50EA Convex ody surface
13. 65EC10EA
Convex
(intracavitary)
Transrectal,
transvaginal
14. 75L38EA Linear ody surface
15. 65EL60EA Linear
( transrectal ) Transrectal

Overview
1-4
No. Model Type Applied
region Illustration
16. 75L53EA Linear ody surface
17. 75LT38EA Linear Intraoperative
18. 35C50HA Convex ody surface
19. 35C20HA Convex ody surface
20. 65EC10HA
Convex
(intracavitary)
Transrectal,
transvaginal
21. 65C15HA Convex ody surface
22. 75L38HA Linear ody surface
23. 75L38H Linear ody surface

Overview
1-5
No. Model Type Applied
region Illustration
24. 75L60H Linear ody 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 ody surface

Overview
1-6
No. Model Type Applied
region Illustration
31. 65EC10HC Convex
(intracavitary)
Transvaginal
32.
65EC10HD Convex
(intracavitary)
Transvaginal
33.
6LE5V/6LE5
Vs Linear Transrectal
34.
6LE7/
6LE7s/
6LE7P
Linear
( transrectal )
Transrectal
35. 6L 7/6L 7s iplanar Transrectal
36. 10L4/10L4s Linear ody surface
37. 7L4/7L4s Linear ody surface