2.1 Applications ........................5 2.2 Precautions For Use ......................5 2.3 Out-of-Box Inspection ......................5 2.3.1 Accessories Inspection ..................5 2.3.2 Transducer Inspection ..................6 2.4 Structure ..........................6 2.4.1 P7-3T/P7-3TE Transducer Functions by Part ............6 2.4.2 P7-3Ts/P7-3TU Transducer Functions by Part ............7 2.4.3 P8-2Ts Transducer Functions by Part ..............8 2.4.4 P8-3Ts Transducer Functions by Part ..............9 Transducer Controls and Inspection ..............11 3.1 Inspection before Use ...................... 11 3.1.1...
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Table of Contents 3.1.3 Brake Operation ....................14 3.1.4 Scanplane Rotation Operation ................16 3.2 Connecting and Disconnecting the Transducer ...............18 3.2.1 TEE Transducer connector with Lock Handle ...........18 3.2.2 TEE Transducer Connector without Lock Handle ..........19 3.3 Electrical Safety .......................20 3.3.1 Electrical Leakage Current Test .................20 3.3.2 Bite-hole Inspection Test ...................21 3.4 Thermal Safety .........................22 3.4.1 Thermal Limits ....................22 3.4.2 Control Settings, Temperature ................23 3.4.3 Temperature Calibration Test ................23 3.5 Cleaning and Disinfecting the Transducer ..............24 3.6 Checking after Turning ON the System ................24 Examination ......................
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. and 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. This posting serves as notice under 35 U.S.C. §287(a) for Mindray patents: http://www. mindrayna.com/patents. 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 •...
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.
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. MINDRAY shall not be liable for loss of data stored in the memory of this system • caused by operator error or accidents. 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.
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Signal Word Meaning Indicates an imminently hazardous situation that, if not avoided, DANGER will result in death or serious injury. Indicates a potentially hazardous situation that, if not avoided, WARNING could result in death or serious injury. Indicates a potentially hazardous situation that, if not avoided, CAUTION may result in minor or moderate injury. NOTE Indicates a potentially hazardous situation that, if not avoided, may result in property damage.
Safety Information Safety Information Safety Classification Please refer to the safety classification information in the related operator’s manual for the ultrasonic diagnostic system that matches with this transducer. 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 gases, such as anesthetic gas or hydrogen, or flammable liquids such as ethanol, near this system, because there is danger of explosion. WARNING ● This ultrasonic transducer is only for use with the specified ultrasonic diagnostic system.
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● Please use the disinfection 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.
Table 1-1 Environmental Conditions Relative humidity Probe Ambient Atmospheric Conditions model temperature pressure (no condensation) Operating 10% to 85%RH 700 hPa to 1060 hPa P7-3T 0 °C to 40 °C Storage and 30% to 90%RH 700 hPa to 1060 hPa -10 °C to 45 °C P7-3Ts transportation P7-3TE P7-3TU Operating 10% to 90%RH 700 hPa to 1060 hPa P8-3Ts 0 °C to 45 °C...
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Safety Information Symbol Description General warning sign Type-BF applied part Serial number Date of manufacture 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. Manufacturer Protection against temporary immersion in water Comply with the requirements of the Council Directive 93/42/EEC (Medical Device Directive). Temperature limit Humidity limitation Atmospheric pressure limitation Operator's Manual...
Overview Overview Applications Refer to the operator’s manual of the ultrasonic diagnostic system. Precautions For Use WARNING The physician must take into account all possible factors before starting the examination. Precautions for using the TEE transducer are: P7-3T/P7-3Ts/P7-3TE/P7-3TU/P8-2Ts is intended to be used on adults only, fetal • imaging and pediatric imaging are not permitted. P8-3Ts is not intended for fetal imaging. • Imaging when the patient exhibits the following or similar conditions: • Esophageal stricture, spasms, lacerations, and trouble swallowing (dysphagia) –...
Perform scanplane rotation inspection, see "3.1.4 Scanplane Rotation Operation".. • Perform leakage test, see "3.3 Electrical Safety". • Contact Mindray or your local representative immediately to report any damage or discrepancies. WARNING To avoid injury to the patient, if any irregularity, substandard function or unsafe condition is observed or suspected, the TEE transducer should not be used.
Overview Name Function Distal tip with Converts the electrical signal into an ultrasonic transducer 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. The lens on the surface is the acoustic lens. Apply ultrasound gel on the acoustic lens for correct operation. Deflection section Deflects to obtain an overall scanning. Flexible shaft Inserts into the mouth cavity or esophagus. Depth is marked on the flexible shaft, unit: cm. Control handle Operates on the transducer deflection or rotation. Left/Right Deflection Used for controlling the transducer left/right tip deflection. control wheel Up/Down Deflection Used for controlling the transducer up/down tip deflection. control wheel Deflection lock Restrain the deflection wheel adjustment. Transmits electrical signals between the transducer body Cable and connector. Motor control push- Controls to scanplane rotation. Range: 0°–180° buttons Connector Connects the transducer to the ultrasonic diagnostic system. 2.4.2 P7-3Ts/P7-3TU Transducer Functions by Part Name Function Distal tip with...
Overview Name Function Flexible shaft Inserts into the mouth cavity or esophagus. Depth is marked on the flexible shaft, unit: cm. Control handle Operates on the transducer deflection or rotation. Up/Down Deflection Used for controlling the transducer up/down tip deflection. control wheel Left/Right Deflection Used for controlling the transducer left/right tip deflection. control wheel Deflection lock Restrain the deflection wheel adjustment. Transmits electrical signals between the transducer body Cable and connector. Motor control push- Controls to scanplane rotation. Range: 0°–180° buttons Connector Connects the transducer to the ultrasonic diagnostic system. 2.4.3 P8-2Ts Transducer Functions by Part Name Function Distal tip with Converts the electrical signal into an ultrasonic transducer 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. The lens on the surface is the acoustic lens. Apply ultrasound gel on the acoustic lens for correct operation.
Overview Name Function Up/Down Deflection Used for controlling the transducer up/down tip deflection. control wheel User-defined key Set by the user in the Ultrasound system preset Transmits electrical signals between the transducer body Cable and connector. Motor control push- Controls to scanplane rotation. Range: 0°–180° buttons Connector Connects the transducer to the ultrasonic diagnostic system. 2.4.4 P8-3Ts Transducer Functions by Part Name Function Distal tip with Converts the electrical signal into an ultrasonic transducer 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. The lens on the surface is the acoustic lens. Apply ultrasound gel on the acoustic lens for correct operation. Deflection section Deflects to obtain an overall scanning. Flexible shaft Inserts into the mouth cavity or esophagus. Depth is marked on the flexible shaft, unit: cm. Control handle Operates on the transducer deflection or rotation.
The endoscope is designed for one-hand operation of the deflection and scanplane controls. 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. WARNING To avoid injury to the patient, if any irregularity, substandard function or unsafe condition is observed or suspected, the TEE transducer should not be used.
The tip deflection brake inspection should be performed on the transducer after taking it out of the box and prior to each exam. Deflect the tip in all four directions (P8-3Ts: up/down) and confirm that the angle is within the ranges specified above (with reference to the endoscope shaft). Confirm that the deflection controls operate smoothly. Check that when the deflection controls are in the neutral position that the transducer tip is also in a neutral position (undeflected). P7-3T/P7-3TE Up/Down Deflection control wheel Left/Right Deflection control wheel Turn upper wheel counterclockwise to move the tip down, 90° minimum Turn upper wheel clockwise to move the tip up, 120° minimum Turn lower wheel counterclockwise to move the tip left, 45° minimum Turn lower wheel clockwise to move the tip right, 45° minimum Operator's Manual...
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Transducer Controls and Inspection P7-3Ts/P7-3TU Left/Right Deflection control wheel Up/Down Deflection control wheel Turn upper wheel counterclockwise to move the tip left, 45° minimum Turn upper wheel clockwise to move the tip right, 45° minimum Turn lower wheel counterclockwise to move the tip down, 90° minimum Turn lower wheel clockwise to move the tip up, 120° minimum P8-2Ts Left/Right Deflection control wheel Up/Down Deflection control wheel Turn upper wheel counterclockwise to move the tip left, 45° minimum Turn upper wheel clockwise to move the tip right, 45° minimum Turn lower wheel counterclockwise to move the tip down, 45° minimum Turn lower wheel clockwise to move the tip up, 120° minimum Operator's Manual...
Turn lower wheel clockwise to move the tip up, 120° minimum 3.1.3 Brake Operation The tip deflection brake inspection should be performed on the transducer after taking it out of the box and prior to each exam. Confirm the brake is in the unlocked position. Deflect the tip to the anterior direction. Move the brake to the locked position. Confirm that the tip is locked in the deflected position. Unlock the brake and confirm the tip straightens easily. Repeat steps 1-5 for the other directions. P7-3T/P7-3TE Left/Right deflection lock: white - unlock Left/Right deflection lock: red - lock Up/Down deflection lock: white - unlock Operator's Manual...
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Transducer Controls and Inspection Up/Down deflection lock: red - lock P7-3Ts/P7-3TU Left/Right deflection lock: blue - lock Up/Down deflection lock: blue - lock P8-2Ts Left/Right/Up/Down deflection lock: - unlock Left/Right/Up/Down deflection lock: - lock P8-3Ts Up/Down deflection lock: blue - lock Operator's Manual...
(longitudinal plane) to 180° (transversal plane, left/right inverted). All planes in between can also be chosen. This makes it possible to scan a conical imaging volume. Rotation Control Figure 3-1 P7-3T/P7-3TE Figure 3-2 P8-2Ts For orientation purposes, the user may choose to start scanning in one of the transverse planes, for instance the standard monoplane indicated as 0°on the system monitor. After rotating the scanplane 90°, scanning occurs in the longitudinal plane, sweeping through two opposite quadrants of the cone. When the scanplane rotates 90°further in the same...
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Transducer Controls and Inspection 90°rotation sagittal to mirror image of transverse plane 90°rotation transverse to longitudinal plane Conic imaging volume Quadrants filled by first 90°rotation Quadrants filled by second 90°rotation Rotation Control of P8-3Ts Short Axis Angle=0° Long Axis Angle=90° Short Axis Angle=180° Scanplane Indicator For orientation purposes, a scanplane indicator has been incorporated on the system display. The actual scanplane angle is indicated by a marker, and the value is also displayed as shown in figure below. The scanplane angle ranges from 0°to 180°.
Press the scanplane control buttons on the handle to rotate the scanplane counterclockwise (0° to 180°) and clockwise (180° to 0°). Confirm the image on the screen changes in relation to the numbers on the scanplane indicator. While pressing the scanplane control buttons (not available for P8-3Ts), the transducer motor should be running as the image is changing. Connecting and Disconnecting the Transducer TEE transducer should be used only with Mindray 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. ●...
Transducer Controls and Inspection Disconnecting the Transducer Turn the lock handle 90° anticlockwise to release the transducer, and pull it out straight. 3.2.2 TEE Transducer Connector without Lock Handle Connecting the Transducer Insert the TEE transducer connector into the system port, then press in fully. Toggle the locking lever to the lock position. Disconnecting the Transducer After freezing or turning off the ultrasonic diagnostic system, toggle the locking lever to the unlock position to unlock the connector of the probe. Pull the probe connector straight out as shown in the figure below. Operator's Manual...
Transducer Controls and Inspection Electrical Safety The electrical leakage current test should be performed on the TEE transducer after taking it out of the box and prior to each exam, alternatively, if the bite-guard inspection test is done prior to each exam, then the electrical leakage current test should be done yearly at a minimum. 3.3.1 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-Part 1. General Requirements for Safety. To maintain patient safety it is important to have a low electrical leakage current in the product. The endoscope shaft has no electrically conducting surfaces, and is covered with a layer of material, which permits neither fluids nor electricity to pass through it. Electrical safety is maintained for the transducer by keeping this material intact. Each TEE transducer is tested for electrical isolation and leakage current before it is shipped to a customer. WARNING ● To avoid injury to the patient, do not use the transducer if the insulating material has been punctured or otherwise compromised.
Transducer Controls and Inspection 3.3.2 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. The test equipment is shown in figure below.
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...
The temperature measurement function should be verified to the specifications at least once a year. Test Setup Assemble the following items for the test. Temperature stabilized water bath • Temperature gauge with accuracy of ± 0.1°C • Temperature Calibration Test Adjust the water bath temperature to 41°±0.1°C and monitor the temperature with the gauge. If an accurate and stable water bath is not available, the added inaccuracy must be taken into account when the temperature is read from the ultrasound system. Deviation of more than ±0.5°C is not acceptable. Maintaining this accuracy without temperature regulation may be difficult. Connect the TEE transducer to the ultrasound system. Press <Freeze> and set patient temperature to be 41°C on ultrasound system. Put the transducer tip in the water bath. At least 10 cm of the distal end must be submerged. Observe the temperature indicated on the system monitor. Wait until the temperature display is stabilized at 41°±0.5°C plus/minus any water bath temperature deviation. 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. Operator's Manual...
Transducer Controls and Inspection Cleaning and Disinfecting the Transducer For cleaning and disinfecting the transducer, see "5 Cleaning and Disinfection". WARNING If you don’t clean and disinfect the transducer, it may become a source of infection. Checking after Turning ON the System CAUTION ● If you keep a hot acoustic lens on the body surface, the patient may be burned. ●...
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.
Examination CAUTION Only use water-soluble acoustic coupling gel. Other coupling gels containing ingredients like ethanol, mineral oil, Iodine, lotions, lanolin, aloe vera or methyl or ethyl parabenzoic acid can cause transducer damage. 4.2.2 Sheath For patient protection, a sterile, single-use, latex sheath can be used over the transducer before performing examination. Use a commercially available transducer sheath. If used, place the latex sheath over the transducer and gastroscope shaft up to but not covering the handle. Rub the tip carefully to ensure that all air bubbles have been removed from the transducer’s acoustic window area. In addition to the gel on the acoustic window, apply a sufficient amount of acoustic coupling gel on the outside of the sheath at the tip of...
. 4.2.4 Ordering Supplies You can order transducer sheath, bite-guard and necessary accessories from the following manufacturer. To order a transducer sheath, you may contact: CIVCO Medical Instruments Co. 102 First Street South, Kalona, IA 52247-9589 USA E-mail: info@civco.com http://www.civco.com 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. NOTE: It is required to practice ALARA when operating ultrasonic diagnostic system. 4.3.1 Cautions The actual techniques for introduction of the TEE 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.
Examination In consideration of the above 2 points, the user should freeze the image, which turns • the power to the transducer off, and allow the endoscope deflection controls to be disengaged whenever active scanning is not desired. Proper patient preparation is essential for successful examinations. This includes • restrictions on food and liquid intake as well as a thorough explanation of the examination procedure and other instructions as the particular situation warrants.
Examination CAUTION To avoid damaging the transducer, do not deflect the distal tip of the transducer by direct application of force. Use the deflection wheels for this task. 4.3.3 Emergency Retraction If the transducer tip should get jammed in a deflected position inside the patient, and all attempts to release the deflected tip should fail, follow the following procedure to assure a safe retraction of the transducer. Disconnect the transducer from the ultrasound system. At an accessible location between the transducer handle and the patient, cut the entire endoscope shaft, including all internal wiring, using heavy duty cutting pliers or another suitable tool. The deflection mechanism is now released and the transducer may be safely retracted. After Examinations After the examination is completed, turn OFF the ultrasonic diagnostic system, remove the bite-guard and disconnect the transducer, and then clean and disinfect the transducer.
After disinfection, rinse the transducer thoroughly with clean water to remove all chemical residues. Chemical residues on the transducer may be harmful to the human body. ● The efficacy of disinfectants solutions is not guaranteed by MINDRAY. Contact the manufacturers for information on the activity of the products. NOTE: ●...
Inspect the probe. If visible dirt still exists, repeat the preceding steps to wash the probe until it is all clean. Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If such defects exist, the probe has reached the end of its service life. In this case, stop using it and contact the Mindray service department. 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. 5.2.1 Compatible Disinfectants Applicable...
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Repeated disinfection will eventually damage the transducer, please check the transducer’s performance periodically. ● Disinfecting incorrectly or with chemicals not recommended by Mindray will void the warranty. WARNING To avoid injury to the patient, if residue from the disinfectant is not removed it can cause irritation and/or burning of the mouth and esophageal tissue.
Transducer For detailed environmental conditions of storage and transportation, see "1.3 Ambient • conditions". 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. Sterilize the carrying case as necessary.
Specifications Specifications P7-3T/P7-3Ts/P7-3TE/P7-3TU Shaft length 110 cm (deviation:±10%) Mechanical Shaft external 11 mm (deviation: +10%, the lower limit is not calculated) dimensions diameter 17.5 mm (deviation: +5%, the lower limit is not calculated) Diameter of the inflexible distal part of the transducer tip ≤17.5 mm Maximum insertion portion diameter: Center frequency 5.0 MHz Transducer type Phased array Number of elements Aperture 9 mm Focus 50 mm Scanplane rotation 0 ~ 180° Temperature precision Temperature range: 17.5~50°C, precision: ±1°C, of which, when the temperature is 43°C, the precision is ±0.5°C Tip deflection Up/Down/Left/Right: ≥120°/90°/45°/45°...
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This page intentionally left blank. P8-3Ts Center frequency 5.0 MHz Transducer type Phased array Number of elements Aperture 7.25 mm Focus 30 mm Scanplane rotation 0 ~ 180° Temperature precision Temperature range: 17.5~50°C, precision: ±1°C, of which, when the temperature is 43°C, the precision is ±0.5°C Tip deflection Up/Down: 120°/90° (Deviation: -10% mm, the upper limit is not calculated) Leakage current / Dielectric Meet the requirements of IEC 60601. strength Biocompatibility All external materials of the multiplane TEE Transducer have passed relevant biocompatibility tests according ISO 10993. P8-2Ts Shaft length 108 cm (deviation: ±10%) Mechanical Shaft external 10.5 mm (deviation: +10%, the lower limit is not calculated) dimensions diameter 17.5 mm (deviation: +5%, the lower limit is not calculated)
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