Mindray P7-3Ts Operator's Manual
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Mindray P7-3Ts Operator's Manual

Mindray P7-3Ts Operator's Manual

Ultrasonic transducer
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P7-3Ts Ultrasonic Transducer
Operator's Manual

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Summary of Contents for Mindray P7-3Ts

  • Page 1 P7-3Ts Ultrasonic Transducer Operator’s Manual...

  • Page 3: Table Of Contents

    1.4   Contraindications ......................... 1-2   1.5   Out-of-Box Inspection ......................1-2   1.6   Structure of P7-3Ts ......................1-3   1.6.1   Transducer Functions by Part ..................1-3   2   Transducer Controls and Inspection ................2-1   2.1  ...
  • Page 4 2.3.1   Electrical Leakage Current Test ................... 2-7   2.3.2   Bite-hole Inspection Test ....................2-8   2.4   Thermal Safety ........................2-9   2.4.1   Thermal Limits ......................2-9   2.4.2   Control Settings, Temperature ..................2-10   2.4.3   Temperature Calibration Test ..................2-10   2.5  ...

  • Page 5: Intellectual Property Statement

    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.

  • Page 6: 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 7: Customer Service Department

    Malfunction of the instrument or part whose serial number is not legible. Others not caused by the instrument or part itself. Customer Service Department Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Manufacturer: Mindray Building, Keji 12th Road South, High-tech industrial park, Address: Nanshan, Shenzhen 518057,P.R.China www.mindray.com Website: service@mindray.com...

  • Page 8: Important Information

    MINDRAY shall not be liable for the results of diagnostic procedures. 9. 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

    Introduction This operator’s manual describes the operating procedure for the transducer P7-3Ts. 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...

  • Page 10: Safety Precautions

    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.
  • Page 11 1. This ultrasonic transducer is only for use with the specified WARNING: ultrasonic diagnostic system. Please refer the ultrasonic diagnostic system operation manual to select the proper transducer. 2. The multiplane TE Transducer should be used only by a qualified physician who has received appropriate training in proper operation of the transducer and in endoscopic techniques as dictated by current relevant medical practices.
  • Page 12 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. 10. Before introducing the transducer: do not rub or spray the tip of the transducer with an anesthetic agent.

  • Page 13: Labels

    Use the P7-3Ts transducer under the following ambient conditions: ambient temperature: 0°C to 40°C relative humidity: 30% to 85% (no condensation) atmospheric pressure: 700 hPa to 1060 hPa 3. Repeated disinfection will eventually damage the transducer, please check the transducer’s performance periodically.
  • Page 14 Label Meaning Indicates safety precautions. The label uses the same signal words as used in the descriptions in the operator’s manual.

  • Page 15: Overview

    2. The TE transducer is intended to be used on adults only. Fetal imaging and pediatric imaging is not permitted. The P7-3Ts transducer is designed for 2D, M Mode, color Doppler (Color), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart.

  • Page 16: Contraindications

    Perform tip deflection inspection. See “2.1.2.1 Tip Deflection Control”. Perform brake inspection. See “2.1.2.2 Brake Operation”. Perform scanplane rotation inspection. See “2.1.2.5 Scanplane Rotation Inspection”. Perform leakage test. See “2.3 Electrical Safety”. Contact Mindray or your local representative immediately to report any damage or discrepancies.

  • Page 17: Structure Of P7-3Ts

    Structure of P7-3Ts P7-3Ts is a phased array transducer, mounted in a sealed tip at the end of a gastroscope. The transducer is intended for imaging of the heart through the esophagus and the stomach.
  • Page 18 Overview Name Function Transmits electrical signals between the transducer body and Cable connector. Connector Connects the transducer to the ultrasonic diagnostic system.

  • Page 19: Transducer Controls And Inspection

    The mechanical operation and physical integrity of the transducer should be checked after taking it out of the box and prior to each exam. If any abnormality is found, immediately stop using the transducer and contact MINDRAY Customer Service Department or sales representative.

  • Page 20: Deflection And Scanplane Rotation Control

    Transducer Controls and Inspection 2.1.2 Deflection and Scanplane Rotation Control The control handle is designed for one-hand operation. Normally the operator takes the control handle in his left hand. Thumb, first and second fingers control the deflection control wheels and scan plane rotation push-buttons. The smallest wheel on the handle is for controlling the transducer left/right tip deflection.
  • Page 21 Transducer Controls and Inspection 1. Check if the maximum deflection of the tip is 90° to 120° WARNING: upward, 60° to 90° downwards and 30° to 45° left/right. If the deflection shows an unwanted amount of free play or exceeds the maximal deflection angles given above, do not use the transducer.
  • Page 22 Transducer Controls and Inspection Unlock-white Left/right Lock-red 1. Confirm the brake is in the unlocked position. 2. Deflect the tip to the anterior direction. 3. Move the brake to the locked position. 4. Confirm that the tip is locked in the deflected position. 5.
  • Page 23 Transducer Controls and Inspection other. As shown in figure below, a 180°rotation of the scanplane fills all four quadrants of the conic imaging volume. The direction of the tip of the endoscope is easily steered using the deflection control wheels on the handle of the instrument to allow exact positioning of the transducer in the esophagus.

  • Page 24: Connecting And Disconnecting The Transducer

    Connecting and Disconnecting the Transducer This transducer should be used only with Mindray compatible ultrasonic diagnostic systems. Before connecting or disconnecting a transducer, freeze or turn off the NOTE: ultrasonic diagnostic system, otherwise the ultrasonic diagnostic system or the transducer may malfunction.

  • Page 25: Electrical Safety

    2.3.1 Electrical Leakage Current Test Mindray ultrasound systems with accessories are designed to meet the requirements for patient safety described in IEC 60601-1 Medical Electrical Equipment-Part1.General Requirements for Safety. To maintain patient safety it is important to have a low electrical leakage current in the product.

  • Page 26: Bite-Hole Inspection Test

    Transducer Controls and Inspection 2.3.2 Bite-hole Inspection Test Bite-holes or other damages of the endoscope surface can alternatively be detected by a simplified test without the access to the ultrasound system, by using the following procedure. The objective of this test is to detect bite-holes. It is safe and easy to perform, but is not an isolation or leakage current test as described in EN 60601-1.

  • Page 27: Thermal Safety

    Thermal Safety Maintaining a safe thermal environment for the patient has been a design priority at Mindray. It is generally agreed that to avoid damage to body tissues, for long term exposures, tissue contact transducer tip temperatures should be less than 43°C. The ultrasound system...

  • Page 28: Control Settings, Temperature

    Transducer Controls and Inspection The system has a lower thermal limit of 17.5°C. If the temperature of the transducer tip reaches 17.5°C, the temperature display turns red. To avoid the risk of esophageal burn for adult patients, reduce WARNING: the time spent imaging at distal tip temperatures in excess of 42°C (107.6°F).

  • Page 29: Cleaning And Disinfecting The Transducer And Bite-Guard

    7. Observe that the Warning pop-up window is displayed. If both steps 6 and 7 are passed the temperature shutdown works as stated. If not, Contact Mindray or your local representative. Cleaning and Disinfecting the Transducer and Bite-guard For cleaning and disinfecting the transducer, please refer to “4 Cleaning and Disinfection”...
  • Page 30 Transducer Controls and Inspection transducer temperature sensor is activated, and the transducer temperature is displayed, indicating the transducer is ready for use. If the calibration test of the transducer fails, (no response from the scanplane buttons after calibration), re-connect the transducer to repeat the calibration test. 3.

  • Page 31: Examination

    3. To avoid injury to the patient, if during the deflection test, a sharp “U-turn” of the transducer tip is observed (the transducer tip angle exceeds the maximum deflection angles), do not use the transducer. Call Mindray or your local representative. 4. Some gels and sterilants can cause an allergic reaction in...

  • Page 32: Couple Gel, Sheath, And Bite-Guard

    Examination Couple Gel, Sheath, and Bite-guard 3.2.1 Couple Gel Apply a sufficient amount of water-soluble acoustic coupling gel on the transducer acoustic window. Only use water-soluble acoustic coupling gel. Other coupling CAUTION: gels containing ingredients like ethanol, mineral oil, Iodine, lotions, lanolin, aloe vera or methyl or ethyl parabenzoic acid can cause transducer damage.

  • Page 33: Bite-Guard

    Call 1-800-445-6741 within the United States or 1-319-656-4447 outside of the United States. To fax orders call: 1-319-656-4451 For details, please contact your local Mindray representative for assistance. Examination The operator should adopt proper ultrasonic scanning procedures and methods according to different target organs.

  • Page 34: Cautions

    Examination 3.3.1 Cautions The actual techniques for introduction of the TE transducer into the patient are beyond the scope of the user guide. There are numerous medical texts and articles which thoroughly address this topic. Observe the following precautionary measures when conducting an exam. Maintenance of an unobstructed airway is a prime consideration for all patients.

  • Page 35: Emergency Retraction

    Examination There are two wheels for controlling the transducer tip deflection. The wheels have brake and freely-moving modes. In the braked mode, the movement of the deflection wheel is restrained. This is used to hold the tip in a certain position. Special care should be taken when inserting and removing the transducer.
  • Page 36 Examination After disinfecting the transducer, confirm that the transducer is in good condition and store it in a suitable place. For details about clean, disinfect, please refer to “4 Cleaning and Disinfection”.

  • Page 37: Performance Test

    Detection positioning model (mm) (mm) depth (mm) accuracy (%) Lateral≤3 P7-3Ts ≤2 (depth≤60) ≤1 (depth≤80) ≥80 Axial≤3 3.5.2 Test Content Requirements: 1. Display: set the brightness and contrast values to clinical (or default) status; 2. Ambient: dark room to simulate actual clinical using;...
  • Page 38 Examination Test Step: 1. Place the probe head gently on the acoustic window of the phantom which is covered by water or gel, and make sure the axial resolution targets are displayed in the center of the image. 2. Adjust the Focus to the axial resolution target group. 3.

  • Page 39: Phantom Usage Illustration

    Examination Adjust display depth, to make horizontal groups display in the image. Adjust the Focus to be in horizontal groups (no explicit standard). Adjust gain, TGC and etc. to make horizontal groups display clearly. Use caliper to measure horizontal target distance by step of 20mm. For all measurement data, value with a maximum deviation to 20mm should be in the range of 19.4mm-20.6mm.
  • Page 40 Examination Lateral resolution test adopts Axial/Lateral Resolution Array A target group in the above figure, distance of which should be 4mm, 3mm, 2mm, 1mm and 0.5mm. Axial resolution test adopts Axial/Lateral Resolution Array B target group in the above figure, intervals of which should be 4mm, 3mm, 2mm, 1mm, 0.5mm and 0.25mm.

  • Page 41: Cleaning And Disinfection

    55°C) during cleaning and disinfections. High temperature may cause the transducer to become deformed or damaged. Cleaning Only the following cleaners are recommended by Mindray to clean the TEE transducers. For the biological effectiveness and the correct use of the cleaners, see the information of the cleaner’s manufacturer:...
  • Page 42 70vol.%IsoPropyl alcohol Enzol/Cidezyme LF Cleaner Active ingredient Concentration Aniosyme N,N-Didecyl-N-Methyl-Poly(oxyethyl)Ammonium Propionate 10-25% Sodium N-Lauryl B-Iminiodipropionate 2,5-10% Ethoxylated Isotridecanol 2,5-10% Monopropylene Glycol 2,5-10% Ethane-1,2-Diol,Homopolymere 0-2,5% PolyHexamethylene Biguanide Hydrochloride 0-2,5% Cidezyme/ Proteolytic enzymes < 5% Enzol T-Spray N-alkyl-(C12-18)-n-N-dimethyl-N-Benzyl-ammonium-chloride; Alkyl-dimethyl-ethyl-benzyl-ammonium-chloride T-Spray II Alkyl-dimethyl-benzyl-ammonium-chloride; Octyl-decyl-dimethyl-ammonium-chloride;...

  • Page 43: Disinfections

    3. To avoid damaging the transducer, do not immerse the transducer in a solution containing ethanol. Disinfections Only the following disinfectants are recommended by Mindray to disinfect the TEE transducers. For the biological effectiveness and the correct use of the disinfectants, see the information of the disinfectants’ manufacturer:...
  • Page 44 NeoDisher Dr.Weigert 100gr: 15,2g glutardialdehyde 19,7g Septo 3000 1,6-dihydroxy-2.5-dioxahexan Nu-Cidex ASP J&J Peracetic Acid Acetic Acid Hydrogen peroxide 0,30% 0,60% < 1,6% Omnicide 14 Coventry Gluteraldehyde 2,60% N.S. Chemicals Omnicide 28 Coventry Gluteraldehyde 2,50% Chemicals Perasafe Dupont Sodium Perborate 40-60% Revital-Ox Steris Hydrogen Peroxide...
  • Page 45 3.5. 3. Disinfecting or sterilizing incorrectly or with chemicals not recommended by Mindray will void the warranty. To avoid injury to the patient, if residue from the disinfectant is WARNING: not removed it can cause irritation and/or burning of the mouth and esophageal tissue.

  • Page 47: Storage And Transportation

    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 original carrying/shipping case to prevent infection.

  • Page 49: Specifications

    Specifications The specifications of this transducer are listed below. Mechanical dimensions Shaft external diameter: 11 mm Shaft length: 100 cm Transducer tip width: 14 mm Transducer tip height: 10.3 mm Length of the inflexible distal part of the transducer tip: 41 mm Transducer Center frequency: 5.0 MHz Type: phased array...
  • Page 51 P/N: 046-003968-00 (V4.0)

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