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Summary of Contents for Mindray XP8-2TU
- Page 1 P7-3T/P7-3Ts/P7-3TE/P7-3TU/P8-2Ts/P8-2TU/P8-3Ts/XP8-2TU Ultrasonic Transducer Operator’s Manual...
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Page 3: Table Of Contents
2.3 Out-of-Box Inspection ......................5 2.3.1 Accessories Inspection ..................5 2.3.2 Transducer Inspection ..................6 2.4 Structure ..........................7 2.4.1 P7-3T/P7-3TE Transducer Functions by Part ............7 2.4.2 P7-3Ts/P7-3TU Transducer Functions by Part ............8 2.4.3 P8-2Ts/P8-2TU Transducer Functions by Part ............9 2.4.4 P8-3Ts Transducer Functions by Part ...............10 2.4.5 XP8-2TU Transducer Functions by Part ............10 Transducer Controls and Inspection ..............13 3.1 Inspection before Use ......................13 3.1.1 Visual and Tactile Inspection ................13 Operator's Manual... - Page 4 Table of Contents 3.1.2 Tip Deflection Control ..................14 3.1.3 Brake Operation ....................16 3.1.4 Scanplane Rotation Operation ................18 3.2 Connecting and Disconnecting the Transducer ...............21 3.2.1 TEE Transducer connector with Lock Handle ...........21 3.2.2 TEE Transducer Connector without Lock Handle ..........22 3.3 Electrical Safety .......................23 3.3.1 Electrical Leakage Current Test .................23 3.3.2 Bite-hole Inspection Test ...................24 3.4 Thermal Safety .........................25 3.4.1 Thermal Limits ....................25 3.4.2 Control Settings, Temperature ................26 3.4.3 Temperature Calibration Test ................26 3.5 Cleaning and Disinfecting the Transducer ..............27...
- Page 5 Table of Contents Specifications ....................... 43 Disposal ......................... 47 Operator's Manual...
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Page 7: Introduction
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. 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: •... -
Page 8: Warning
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: •... -
Page 9: Important Information: Customer Responsibility
• 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. - Page 10 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.
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Page 11: Safety Information
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 diagnostic ultrasound system. - Page 12 ● The deflection may after prolonged use develop an unwanted amount of free play. In that case, contact the Mindray Customer Service Department or sales representative to readjust the steering of the transducer. In this way, the risk of “buckling” or “U-turning” of the transducer in the esophagus is minimized.
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Page 13: Ambient Conditions
● 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. -
Page 14: Symbols
P8-2Ts/ Operating 17.5 °C to 42.7 °C 20% to 85%RH 700 hPa to 1060 hPa P8-2TU Storage and -20 °C to 55 °C 20% to 95%RH 700 hPa to 1060 hPa transportation XP8-2TU Operating 10 °C to 40 °C 30% to 85%RH 570 hPa to 1060 hPa Storage and -20 °C to 40 °C 30% to 95%RH 570 hPa to 1060 hPa transportation Symbols This system uses the symbols listed in the following table. Their meanings are explained as follows. -
Page 15: Overview
Refer to the operator’s manual of the diagnostic ultrasound 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/P8-2TU/XP8-2TU 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) –... -
Page 16: Transducer Inspection
• 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. -
Page 17: Structure
TEE transducer 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. Among them, the tip of P7-3T/P7-3Ts/P7-3TE/P7-3TU/P8-2Ts/P8-2TU rotates using the motor control push-button on the control handle, the tip of P8-3Ts rotates using the scanplane rotation wheel on the control handle, and the tip of XP8-2TU rotates using the control push-buttons on the control handle electronically. The probe tip rotates using the deflection control wheel on the handle for accurate positioning in the esophagus. -
Page 18: P7-3Ts/P7-3Tu Transducer Functions By Part
Overview Name Function 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 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. 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. Cable Transmits electrical signals between the transducer body and connector. -
Page 19: P8-2Ts/P8-2Tu Transducer Functions By Part
Overview 2.4.3 P8-2Ts/P8-2TU 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. Deflection lock lever Restrain the deflection wheel adjustment. 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 User-defined key Set by the user in the Ultrasound system preset Cable Transmits electrical signals between the transducer body and connector. Motor control push- Controls to scanplane rotation. Range: 0°–180° buttons Connector Connects the transducer to the ultrasonic diagnostic... -
Page 20: P8-3Ts Transducer Functions By Part
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. Deflection control The larger wheel on the handle is for controlling the probe wheel tip deflection. Scanplane rotation The wheel on top is the scanplane rotation control wheel. wheel Controls to scanplane rotation. Range: 0°-180°. Deflection lock Restrain the deflection wheel adjustment. Cable Transmits electrical signals between the transducer body and connector. Connector Connects the transducer to the ultrasonic diagnostic system. 2.4.5 XP8-2TU Transducer Functions by Part 4 5 6 7 8 9 Operator's Manual... - Page 21 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. Up/Down Deflection Used for controlling the transducer up/down tip deflection. control wheel Deflection lock lever Restrain the deflection wheel adjustment. Left/Right Deflection Used for controlling the transducer left/right tip deflection. control wheel User-defined key Set by the user in the Ultrasound system preset Control push-buttons Controls to scanplane rotation. Range: 0°–360° Cable Transmits electrical signals between the transducer body and connector. Connector Connects the transducer to the ultrasonic diagnostic system. Operator's Manual...
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Page 23: Transducer Controls And Inspection
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. -
Page 24: Tip Deflection Control
Transducer Controls and Inspection 3.1.2 Tip Deflection Control WARNING ● If the deflection shows an unwanted amount of free play, do not use the transducer. Contact the service organization to re-adjust the steering of the transducer. In this way, the risk of "buckling" or "U-turning" of the transducer in the esophagus is minimized. - Page 25 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/P8-2TU 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...
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Page 26: Brake Operation
Transducer Controls and Inspection P8-3Ts Up/Down Deflection control wheel Turn lower wheel counterclockwise to move the tip down, 90° minimum Turn lower wheel clockwise to move the tip up, 120° minimum XP8-2TU 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 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. Operator's Manual... - Page 27 Transducer Controls and Inspection P7-3T/P7-3TE Left/Right deflection lock: white - unlock Left/Right deflection lock: red - lock Up/Down deflection lock: white - unlock Up/Down deflection lock: red - lock P7-3Ts/P7-3TU Left/Right deflection lock: blue - lock Up/Down deflection lock: blue - lock P8-2Ts/P8-2TU Operator's Manual...
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Page 28: Scanplane Rotation Operation
Transducer Controls and Inspection Left/Right/Up/Down deflection lock: - unlock Left/Right/Up/Down deflection lock: - lock P8-3Ts Up/Down deflection lock: blue - lock XP8-2TU Left/Right deflection lock: blue - lock Up/Down deflection lock: blue - lock 3.1.4 Scanplane Rotation Operation CAUTION ● Do not use excessive force on the scanplane rotation control wheel at its outer positions as this may damage the gastroscope mechanism. ● The transducer scan plane can be rotated from 0° (transversal plane) via 90°... - Page 29 Transducer Controls and Inspection Rotation Control Figure 3-1 P7-3T/P7-3TE Figure 3-2 P8-2Ts/P8-2TU Figure 3-3 XP8-2TU 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 direction, scanning occurs in the mirror image of the first transverse plane. The only two planes that are equivalent are the two transverse planes; one being the mirror image of the 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 30 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°.
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Page 31: Connecting And Disconnecting The Transducer
Confirm the image on the screen changes in relation to the numbers on the scanplane indicator. – While pressing the motor control push-buttons (not available for P8-3Ts and XP8- 2TU), the transducer motor should be running as the image is changing. – For P8-3Ts: use the scanplane rotation wheel to control the rotation. – For XP8-2TU: use the control push-buttons to control the rotation. 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. ● Place the cable properly to avoid being treaded or wrapping with other devices. DO NOT allow the transducer head to hang free. -
Page 32: Tee Transducer Connector Without Lock Handle
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. Operator's Manual... -
Page 33: Electrical Safety
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. 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. -
Page 34: Bite-Hole Inspection Test
§19 must be performed once a year, or as required by local regulation. The leakage limits associated with Type BF Applied Part must be met. The test requires access to the ultrasound system and to standardized test equipment. The transducer has to be immersed in a Normal Saline solution (50g NaCl per liter water) to above the 40 cm mark (but below the handle). Mindray recommends keeping a written log of the results. 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,... -
Page 35: 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... -
Page 36: Control Settings, Temperature
42 °C (107.6 °F). At 42 °C (107.6 °F) or higher, the exposure time of the P7-3T/P7-3Ts/P7-3TE/P7-3TU/P8-2Ts/P8-2TU/P8-3Ts/ XP8-2TU probe for adult applications should be limited to 10 minutes or less. There is no sufficient data to prove the thermal tolerance of the esophagus in neonate and pediatric patients, but it is apparently these patients are more vulnerable than adults. -
Page 37: Cleaning And Disinfecting The Transducer
Transducer Controls and Inspection 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. 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. - Page 38 This page intentionally left blank.
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Page 39: Examination
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. -
Page 40: Sheath
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... -
Page 41: Ordering Supplies
. 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. -
Page 42: Operation Of Deflection Controls
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. -
Page 43: Emergency Retraction
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. - Page 44 This page intentionally left blank.
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Page 45: Cleaning And Disinfection
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: ●... -
Page 46: Before Processing
2,2-Iminodiethanol 1-2% P7-3TU diethanolamine P7-3TE Prolystica 2x Ethanolamine 1-5% P8-3Ts conc. Enzymatic Protease 0.1-1% P8-2Ts Presoak & cleaner Ethoxylated alcohol 1-5% P8-2TU Polyalkylene glycol 1-5% XP8-2TU Glycerine 1-5% EMpower Proteolytic enzymes < 2% P7-3T P7-3Ts Metrizyme Proteolytic enzymes < 2% P7-3TU P7-3TE P8-3Ts P8-2Ts P8-2TU WIP’ANIOS Association of surfactants, P8-2Ts CLEAN’UP... -
Page 47: Disinfections
Or follow the rinsing method specified by the cleaner manufacturer. Use moistened soft cloth to wipe the residual cleaners on the handle, cable, and connector. Dry the probe with a disposable lint-free soft cloth or tissue. Do not dry the probe by heating. Inspect the probe. If visible dirt still exists, repeat the preceding steps to wash the probe until it is all clean. 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. 5.3.1 Compatible Disinfectants Applicable Disinfectant... -
Page 48: Disinfection Procedure
P7-3Ts P7-3TU P7-3TE P8-3Ts ® CIDEX Ortho-phthalaldehyde 0.55% P7-3T (applicable for FDA region only) P7-3Ts Metricide OPA Plus Ortho-phthalaldehyde 0.60% P7-3TU (applicable for FDA region only) P7-3TE P8-3Ts P8-2Ts P8-2TU XP8-2TU ® ® Revital-Ox Resert HLD Hydrogen Peroxide 1.4-2.3% P7-3T P7-3Ts P7-3TU P7-3TE 2-Fluroic Acid ≤2.50 P8-3Ts XP8-2TU ™ UltrOx HLD Hydrogen Peroxide 1.4-2.3%... - Page 49 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.
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Page 51: Storage And Transportation
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. Tip cover The tip cover encloses and protects the distal end/scanhead of the endoscope from being exposed to mechanical strain during transportation and storage. - Page 52 This page intentionally left blank.
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Page 53: Specifications
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 Diameter of 17.5 mm (deviation: +5%, the lower limit is not calculated) the inflexible distal part of the transducer tip Maximum ≤17.5 mm insertion portion diameter: Transducer type Phased array Number of elements 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° (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. - Page 54 Phased array Number of elements 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°/45°/45°/45° (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. XP8-2TU Shaft length 109.5 cm (deviation: ±10%) Mechanical Shaft external 8mm (deviation: +10%, the lower limit is not calculated) dimensions diameter Diameter of 17.5mm (deviation: +5%, the lower limit is not calculated) the inflexible distal part of the transducer tip Maximum ≤17.5mm insertion portion diameter Operator's Manual...
- Page 55 Specifications XP8-2TU Transducer type Phased array Number of elements 2048 Scanplane rotation 0 ～ 360° 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 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. Operator's Manual...
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- Page 57 Disposal Disposal NOTES: ● Follow the local regulations or hospital's guideline when disposing this device. ● Be sure to clean and sterilize this device before disposing it. ● Contact your MINDRAY representatives when disposing this device. ● Follow the disposal control policy for your office, department, or hospital when disposing contaminated items such as probe covers or other disposable items. Operator's Manual...
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- Page 59 P/N: 046-021009-00 (4.0)
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