Mindray 35C50EB Operator's Manual
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Mindray 35C50EB Operator's Manual

Mindray 35C50EB Operator's Manual

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Ultrasonic Transducer
Operator's Manual

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Summary of Contents for Mindray 35C50EB

  • Page 1 Ultrasonic Transducer Operator’s Manual...

  • Page 3: Table Of Contents

    Contents Contents ..........................i Overview ........................1-1 Safety Classification ......................1-1 Applications .......................... 1-1 Acoustic Power ........................1-1 Transducer/Needle-guided Bracket Model ................1-1 Composition ........................1-21 Procedures for Operating the Transducer ................. 1-26 Connecting the Transducer to the System .............. 2-1 Connecting and Disconnecting the Transducer ..............

  • Page 5: Contents

    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.
  • Page 6 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.
  • Page 7 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 www.mindray.com Website: E-mail service@mindray.com Address: Tel: +86 755 81888998 +86 755 26582680 Fax: EC-Representative: Shanghai International Holding Corp. GmbH(Europe) Address: Eiffestraβe 80, Hamburg 20537, Germany...
  • Page 8 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.
  • Page 9 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.
  • Page 10 Safety Precautions Meaning of Signal Words DANGER WARNING CAUTION In this operator’s manual, 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 Indicates an imminently hazardous situation that, if not...
  • Page 11 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.
  • Page 12 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.
  • Page 13 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. Label Meaning Indicates the direction of the lock handle.

  • Page 15: Overview

    ALARA (As Low As Reasonably Achievable) principle. Please refer to the operator’s manual of the ultrasonic diagnostic system. Transducer/Needle-guided Bracket Model 1.4.1 Transducer Model Applied Model Type Illustration region 35C50EB Convex Body surface...
  • Page 16 Overview Applied Model Type Illustration region 35C50P Convex Body surface Convex Transrectal, 65EC10EB (intracavitary) transvaginal 75L38EB Linear Body surface 75L38P Linear Body surface 65C15EA Convex Body surface 75L60EA Linear Body surface 35C20EA Convex Body surface...
  • Page 17 Overview Applied Model Type Illustration region 65C15EAV Convex Body surface 75L50EAV Linear Transrectal 50L60EAV Linear Transrectal 35C50EA Convex Body surface Convex Transrectal, 65EC10EA (intracavitary) transvaginal 75L38EA Linear Body surface Linear 65EL60EA Transrectal transrectal...
  • Page 18 Overview Applied Model Type Illustration region 75L53EA Linear Body surface 75LT38EA Linear Intraoperative 35C50HA Convex Body surface 35C20HA Convex Body surface Convex Transrectal, 65EC10HA (intracavitary) transvaginal 65C15HA Convex Body surface 75L38HA Linear Body surface 75L38HB Linear Body surface...
  • Page 19 Overview Applied Model Type Illustration region 75L60HB Linear Body surface Convex 65EC10EC Transvaginal (intracavitary) Convex Transvaginal 65EC10ED (intracavitary) 65L50HAV Linear Transrectal Linear 65EL66HA Transrectal transrectal Linear Intraoperative 75LT40HA Linear Body surface 75L53HA...
  • Page 20 Overview Applied Model Type Illustration region Convex Transvaginal 65EC10HC (intracavitary) Convex Transvaginal 65EC10HD (intracavitary) 6LE5V/6LE5 Linear Transrectal 6LE7/ Linear 6LE7s/ Transrectal transrectal 6LE7P 6LB7/6LB7s Biplanar Transrectal 10L4/10L4s Linear Body surface 7L4/7L4s Linear Body surface...
  • Page 21 Overview Applied Model Type Illustration region 7L6/7L6s Linear Body surface 6CV1/6CV1 Convex Transrectal, s/6CV1P (intracavitary) transvaginal 3C1/3C1s Convex Body surface 3C5/3C5s Convex Body surface 3C5A/3C5P Convex Body surface C5-2/C5-2s Convex Body surface V10-4/10-4s Convex Transvaginal...
  • Page 22 Overview Applied Model Type Illustration region V10-4B/ V10-4Bs/ Convex Transvaginal V10-4BP 6C2/ 6C2s/ Convex Body surface 6C2P 7L4A/7L4P Linear Body surface L11-4/L11- Linear Body surface L12-4/L12- Linear Body surface L7-3/L7-3s Linear Body surface L14-6/L14- Linear Body surface 6s/L14-6P...
  • Page 23 Overview Applied Model Type Illustration region 7L5/7L5s Linear Body surface /7L5P Bi-plane 65EB10EA Transrectal (convex) 10L24EA Linear Body surface 2P2/ 2P2s/ Phased Body surface 2P2P P7-3/P7- Phased Body surface 3s/P7-3E P12-4/ Phased Body surface P12-4s...
  • Page 24 Overview Applied Model Type Illustration region P4-2/P4-2s Phased Body surface 7LT4/ Intra- operation, 7LT4s/ Linear Body surface 7LT4P CB10- Bi-plane 4/CB10-4P/ (convex & Transrectal CB10-4E convex) L14-6Ns Linear Body surface CW2s Pencil probe Body surface C5-2E Convex Body surface 1-10...
  • Page 25 Overview Applied Model Type Illustration region C6-2Gs Convex Body surface C7-3E Convex Body surface L12-3E Linear Body surface L14-6NE Linear Body surface L14- 6WE/L14- Linear Body surface V11-3E/V11- Convex Transvaginal 1-11...
  • Page 26 Overview Applied Model Type Illustration region P4-2E Phased Body surface CW5/CW5s Pencil probe Body surface C11-3E/ Convex Body surface C11-3s V11- Convex Transvaginal 3BE/V11-3B V11-3WE/ Convex Transvaginal V11-3Ws L7-3E Linear Body surface 1-12...
  • Page 27 Overview Applied Model Type Illustration region P10- Phased Body surface 4E/P10-4s P4-2NE Phased Body surface C5-1s Convex Body surface SP5- Phased Body surface 1s/SP5-1E LM14- Linear Body surface 6E/LM14-6s L10-3E/L10- Linear Body surface 1-13...
  • Page 28 Overview Applied Model Type Illustration region SC5-1E Convex Body surface L16- 4HE/L16- Linear Body surface Convex Body surface C5-1U Convex Body surface SC8-2U Convex Transvaginal V11-3HU Linear Body surface L14-6WU L11-3U Linear Body surface 1-14...
  • Page 29 Overview Applied Model Type Illustration region SP5-1U Phased Body surface Convex Body surface SC5-1U L20-5U/L20- Linear Body surface LM16-4U Linear Body surface Convex Body surface C5-1E Linear Body surface L9-3U L14- Linear Body surface 5WU/L14- 1-15...
  • Page 30 Overview Applied Model Type Illustration region Convex Body surface C5-2 SC6-1U Convex Body surface P10-4U Phase Body surface C6-2GU Convex Body surface 100. C11-3U Convex Body surface 101. P7-3U Phase Body surface 102. L16-4HU Linear Body surface 103. C4-1U Convex Body surface 104.
  • Page 31 Overview Applied Model Type Illustration region 105. L9-3E Linear Body surface 106. 6LB7E Biplanar Transrectal Tips: the transducer whose model is ended with an “s” (7L5s, for example) is to be used with the Doppler ultrasound system, except the connector of this transducer, other parts are the same as the corresponding transducer whose model is not ended with an “s”...
  • Page 32 NGB-001 35C50HA Metal/needle un- 25°, 35°, 45° 13G, 15G, 16G, 18G, 20G detachable 35C50EA Metal/needle 25°, 35°, 45° 14G, 16G, 18G, 20G, 22G 35C50EB detachable 35C50P NGB-002 75L38HA Metal/needle un- 40°, 50°, 60° 13G, 15G, 16G, 18G, 20G detachable 75L38HB...
  • Page 33 Overview Model Matched Type Biopsy Applicable Biopsy Transduce Angle/Depth Needle r(s) (±1°) 65C15HA 12.7°, 24.2° 13G, 15G, 16G, 18G, 20G NGB-005 Metal/needle un- detachable 65C15EA 65C15EAV 6C2(s) 6C2P 3C5(s) Plastic/needle 25°, 35°, 45° 13G, 15G, 16G, 18G, 20G NGB-006 detachable, 3C5A metal 3C5P...
  • Page 34 Overview Model Matched Type Biopsy Applicable Biopsy Transduce Angle/Depth Needle r(s) (±1°) 7LT4(s) 30°, 40°, 50° 13G, 15G, 16G, 18G, 20G NGB-010 Metal/needle detachable 7LT4P 75LT38EA 75LT40HA 2P2(s) 11°, 23° 13G, 15G, 16G, 18G, 20G NGB-011 Metal/needle un- detachable 2P2P P4-2(s) P4-2E P4-2NE...

  • Page 35: Composition

    Overview Model Matched Type Biopsy Applicable Biopsy Transduce Angle/Depth Needle r(s) (±1°) NGB-031 SC5-1U metal/needle 25°, 35°, 45° 14G, 16G, 18G, 20G, 22G detachable NGB-034 L9-3U/L9- Metal: 4G, 16G, 18G, metal/needle 40°, 50°, 60° 20G, 22G detachable NGB-036 C4-1U Metal: 14G、16G、 metal/needle 7°, 25°, 35°...
  • Page 36 Overview <2> <1> <3> <4> <5> Name Function <1> Transducer head Converts the electrical signal into an ultrasonic signal, focusing the sound beams in a given direction; meanwhile, it receives the reflected ultrasonic signal and converts it into an electrical signal for transmission over the cable.
  • Page 37 Overview Name Function Converts the electrical signal into an ultrasonic signal, <1>Transducer head focusing the sound beams in a given direction; meanwhile, <1> (convex) it receives the reflected ultrasonic signal and converts it into an electrical signal for transmission over the cable. <2>...
  • Page 38 Overview 6LE7: Name Function Converts the electrical signal into an ultrasonic signal, focusing the sound beams in a given direction; meanwhile, it receives the reflected ultrasonic signal and converts it into an <1> Transducer head electrical signal for transmission over the cable. The lens on the surface is the acoustic lens.
  • Page 39 Overview Intraoperative transducers 7LT4/7LT4s/75LT38EA/75LT40HA (Take 7LT4 as an example): Name Function Converts the electrical signal into an ultrasonic signal, focusing the sound beams in a given direction; meanwhile, it receives the reflected ultrasonic signal <1> Transducer head and converts it into an electrical signal for transmission over the cable.

  • Page 40: Procedures For Operating The Transducer

    Overview Procedures for Operating the Transducer This section describes general procedures for operating the transducer. The proper clinical technique to be used for operating the transducer should be selected on the basis of specialized training and clinical experience. 1-26...
  • Page 41 Overview Procedures for operating (with biopsy function): Inspection before examination Connection to the ultrasonic diagnostic system Examinations Biopsy procedure Disconnection to the ultrasonic diagnostic system Sterilization of the needle- guided bracket Wiping off the ultrasound gel Inspection after use Washing the transducer with water Storage Draining/drying Immersion into disinfectant...
  • Page 42 Overview Procedures for operating (with no biopsy function): Inspection before examination Connection to the ultrasonic diagnostic system Examinations Disconnection to the ultrasonic diagnostic system Wiping off the ultrasound gel Washing the transducer with water Draining/drying Disinfection Immersion into disinfectant Removing the transducer from disinfectant Rinsing the transducer into sterile water Draining/drying...
  • Page 43 Overview Disinfect the transducer and sterilize the needle-guided bracket before and after an ultrasound-guided biopsy WARNING: procedure is performed. Failure to do so may cause the transducer and the needle-guided bracket become source of infection. 1-29...

  • Page 45: Connecting The Transducer To The System

    Connecting the Transducer to the System The transducer can be used with compatible ultrasonic diagnostic systems. NOTE: Before connecting or disconnecting a transducer, freeze or turn off the ultrasonic diagnostic system, otherwise the ultrasonic diagnostic system or the transducer may malfunction. 2.1 Connecting and Disconnecting the Transducer For non-portable Doppler Ultrasound System Compliant Transducer...
  • Page 46 Connecting the Transducer to the System For Portable Doppler Ultrasound System Compliant Transducer Connecting the transducer: To connect the transducer, insert the connector fully into the socket. Toggle the transducer lock lever, which beside the socket, to the upper position. See the figure below. transducer lock lever Disconnecting the Transducer: To disconnect the transducer, toggle the transducer lock lever to the lower position, and pull...

  • Page 47: Inspection Before And After Use

    Inspection before and after use must be performed as described below to ensure safe operation of the transducer. If any abnormality is found, immediately stop using the transducer and contact MINDRAY Customer Service Department or sales representative. 3.1 Check the External Appearance of the...

  • Page 49: Operating Procedures

    Operating Procedures This section describes general procedures for operating the transducer. The operator should have adequate clinical experience and received related training. 1. Clean and disinfect the transducer before and after each CAUTION: examination. 2. When using the transducer, wear sterile gloves to prevent infection.

  • Page 50: Utilizing The Transducer Sheath

    Operating Procedures Utilizing the Transducer Sheath A legally marketed transducer sheath must be installed over the transducer before performing intra-cavitary examination. Protective barriers may be required to minimize disease transmission. Transducer sheaths are available for use with all clinical situations where infection is a concern.

  • Page 51: When The Immersion Method Is Used

    Water immersion is required when performing an ultrasound exam using transducers, including 6LE7(s), 6LE7P, 6LB7(s), 6LB7E, 65EL60EA, and 65EL66HA. The Mindray recommends using syringe: CIVCO 610-224. Transducer 6LB7 is used as an example to describe the immersion method. Perform the following operations before using the syringe.
  • Page 52 Operating Procedures 2. Fill syringe with sterile water and connect extension tube to syringe, discharge all air in the tube. Attach the syringe to transducer fill port. 3. Orient transducer downward and inject sterile water up to the level a few cm above the end of the transducer surface.
  • Page 53 Operating Procedures 4. Orient transducer upward to discharge air in transducer cover.
  • Page 54 Operating Procedures 5. Turn the valve of the syringe to the position shown in the right figure, and then push the plunger of the syringe to discharge the air. 6. Return the valve of the syringe to the original position; orient the transducer downward to discharge sterile water.

  • Page 55: Examinations

    Operating Procedures 4.4 Examinations The operator should adopt proper ultrasonic scanning procedures and methods according to different target organs. NOTE: It is required to practice ALARA when operating ultrasonic diagnostic system. 4.5 After Examinations After the examination is completed, turn OFF the ultrasonic diagnostic system and refer to Chapter 5 “Cleaning and Disinfection”...

  • Page 57: Cleaning And Disinfection

    Cleaning and Disinfection After completing each examination, clean and disinfect (or sterilize) the probes as required. When biopsy procedures have been performed, be sure to sterilize the needle- guided bracket. Fail to do so may result in the probe and the needle-guided bracket to becoming sources of infection.

  • Page 58: High Level Disinfections

    Disinfecting by Immersion 1. Wear sterile gloves to prevent infection. 2. Clean the transducer before disinfecting it. MINDRAY recommends the following solutions to disinfect the transducer. Refer to the instructions provided by the chemical manufacturer concerning concentration of the disinfectant solution, method of disinfection and dilution and cautions during use.

  • Page 59: Sterilization

    For intra-operative transducers, they have to be sterilized after completing each examination. 1. Wear sterile gloves to prevent infection. 2. Clean the transducer before sterilizing it. MINDRAY recommends the following solutions to sterilize the transducer. Hydrogen Peroxide and Peroxyacetic Acid -based sterilization solution...
  • Page 60 Cleaning and Disinfection Glutaraldehyde-based sterilization solution Trade Name Chemical Name Procedures Cidex Activated Glutaraldehyde 2.2-2.7% Solution Glutaraldehyde Soak the transducer into the activated (applicable for CE solution for 10 hours (20-25℃). region) Please refer to the instructions provided Cidex Activated by the manufacturer of the solution for Dialdehyde details.

  • Page 61: Needle-Guided Bracket And Biopsy

    Needle-guided Bracket and Biopsy For details about the needle-guided bracket and biopsy operations, please refer to the needle-guided bracket operator’s manual.

  • Page 63: Storage And Transportation

    Storage and Transportation Note: For details of storage time and condition for disinfected probes or sterilized probes, please refer to Technical standard for Disinfection of Medical and Health Structures. When all examinations for the day have been completed, confirm that the transducer is in good condition and store it in a suitable place so that the next examination can be conducted smoothly.
  • Page 64 Relative humidity: 30% to 95% (no condensation) Atmospheric pressure: 700 hPa to 1060 hPa When the transducer is sent to MINDRAY Customer Service Department or sales representative for repair, be sure to disinfect it and keep it in the carrying case to...

  • Page 65: Specifications

    Specifications The specifications of the transducers are listed below. Center Model Cable Length Frequency 3.5MHz 1950±50mm 35C50EB 3.5MHz 1950±50mm 35C50P 6.5MHz 1950±50mm 65EC10EB 7.5MHz 1950±50mm 75L38EB 7.5MHz 1950±50mm 75L38P 6.5MHz 65C15EA 1950±50mm 7.5MHz 75L60EA 1950±50mm 3.5MHz 35C20EA 1950±50mm 6.5MHz 65C15EAV 1950±50mm...
  • Page 66 Specifications Center Model Cable Length Frequency 6.5MHz 65EL66HA 1950±50mm 7.5MHz 75LT40HA 1950±50mm 7.5MHz 75L53HA 1950±50mm 6.5MHz 65EC10HC 1950±50mm 6.5MHz 65EC10HD 1950±50mm 6.5MHz 6LE5V 2690±50mm 6.5MHz 6LE5Vs 2790±50mm 6.5MHz 6LE7/6LE7P 1950±50mm 6.5MHz 6LE7s 2050±50mm 6.5MHz 65EB10EA 1950±50mm 10MHz 10L24EA 1950±50mm Convex: 6.5MHz 6LB7 1950±50mm Linear: 6.5MHz...
  • Page 67 Specifications Center Model Cable Length Frequency 6.5MHz V10-4B 1950±50mm 6.5MHz V10-4Bs 2050±50mm 6.5MHz 6C2/6C2P 1950±50mm 6.5MHz 6C2s 2050±50mm 7.5MHz 7L4A/7L4P 1950±50mm 7.5MHz L11-4 1950±50mm 7.5MHz L11-4s 2050±50mm 7.5MHz L12-4 1950±50mm 7.5MHz L12-4s 2050±50mm 5MHz L7-3 1950±50mm 5MHz L7-3s 2050±50mm L14-6/ L14-6P 10MHz 1950±50mm L14-6s...
  • Page 68 Specifications Center Model Cable Length Frequency 10MHz L14-6WE 1950±50mm 3MHz P4-2E 1950±50mm 6.5MHz V11-3E 1950±50mm 5MHz 1610±50mm 5MHz CW5s 2050±50mm 6.5MHz C11-3E 1950±50mm 6.5MHz C11-3s 2050±50mm 6.5MHz V11-3BE 1950±50mm 6.5MHz V11-3WE 1950±50mm 6.5MHz 100. V11-3Ws 2050±50mm 5.0MHz 101. L7-3E 1950±50mm 6.5MHz 102.
  • Page 69 Specifications Center Model Cable Length Frequency L11-3U 7.0MHz 122. 1950±50mm SP5-1U 3.0MHz 123. 1950±50mm LM16-4U 10.0MHz 124. 1950±50mm SC5-1U 3.0MHz 125. 1950±50mm L20-5U 13.5MHz 126. 1950±50mm C5-1E 3.0MHz 127. 1950±50mm L9-3U 6.0MHz 128. 1950±50mm L14-5WU 9.0MHz 129. 1950±50mm C6-2 4.0MHz 130.
  • Page 70 Specifications Matched Atmospheric Temperature Relative Humidity Ultrasound Pressure System 20%～85% (SP5-1E/LM14- 6E/LM14-6s/C6-2Gs/SP5- 1U/LM16-4U/V11-3HU/L11- 0°C～40°C 700 hPa～1060 hPa 3U/L9-3U/C6-2/P10-4U/C6- 2GU/C11-3U/SC6-1U/L9- 3E/V11-3HE) 0℃~ 35℃(L20- 15%~ 80% 700 hPa~ 1060 hPa 5U/L14-5WU/C4- 1U/L20-5E) 18℃~ 30℃(D8-4U) 30%~ 75% 700 hPa~ 1060 hPa 18℃~ 30℃(DE10- 20%~ 85% 700 hPa~ 1060 hPa...
  • Page 71 P/N: 046-001134-00 (V25.0)

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