© 2004-2007 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. Product Information Product Name: Ultrasonic Transducer Model: 35C50EB Issued date of this manual: 2007-02 Version: 1.1 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 copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. 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, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden, , MINDRAY are the registered trademarks or EL mer omnitab [Dis trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners, Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. Al information contained in this manual is believed to be correct. Mindray shall not be liable for errors cont 1ed herein nor for incidental or consequential damages in connection with thefurnishing, performance, or use of this manual. Mindray is responsible for safety, reliability and performance of this product only in the condition that: ® all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; ® the electrical installation of the relevant room complies with the applicable national and local requirements; the product is used in accordance with the instructions for use. A wa It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health. Warranty 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: © any Mindray product which has been subjected to misuse, negligence or accident; © any Mindray product from which Mindray’s original serial number tag or product identification markings have been altered or removed; © any product of any other manufacturer.Return Policy Return Procedure In the event that it becomes necessary to return this product or part ofthis product to Mindray, the following procedure should be followed: 4. Obtain return authorization: Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Returned shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return, 2. Freight policy: The customer is responsible for freight charges when this product is shipped to Mindray for service (this includes customs charges). 3. Retum address: Please send the part(s) or equipment to the address offered by Customer Service department Company Contact Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building, Keji 12th Road South, Hitech Industrial Park, Nanshan, Shenzhen 518057, P.R.China Tel: +86 755 26582479 26582888 Fax: +86 755 26582934 26582500 umImportant Information 1. The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product. 2. The warranty does not cover the following items, even during the warranty period: (1) Damage or loss due to misuse or abuse. (2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, ete. (3) Damage or loss caused by failure to meet the specified conditions for this equipment, such as inadequate power supply, improper installation, or unacceptable ambient conditions. (4) Damage or loss due to mobile use in a vehicle that is not authorized by MINDRAY, (5) Damage or loss involving equipment purchased from a source other than MINDRAY or its authorized distributors or agents. 3. This equipment shall not be used by persons other than fully qualified and certified ‘medical personnel. 4, Do not make changes or modifications to this product. 5. Inno event shall MINDRAY be liable for problems, damage, or loss caused by relocation, modification, or repair performed by personnel other than those designated by MINDRAY. 6. Contact your MINDRAY representative when disposing of this equipment. MINDRAY shall not be liable for damage or loss that may result from the disposal of this product without consulting your MINDRAY representative. 7. The purpose of this equipment is to provide doctors 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. 8. This manual contains warnings regarding foreseeable potential dangers. Be alert at all times to dangers other than those indicated. 9. MINDRAY shall not be liable for damage or loss that result from negligence or from ignoring the precautions and operating instructions contained in this operation manual. 10. Please keep this operation manual with the equipment. Whenever the administrator or Person responsible for this equipment is changed, ensure to hand over this operation manual.Introduction This operation manual describes the operating procedure for the transducer 35C50EB. To ensure safe and correct operation of the transducer, read the operation manual carefully and understand the transducers clearly before operation. For the operating procedures for the diagnostic ultrasound system and other devices, please refer to the relevant manuals.Safety Precautions 1. Meaning of Signal Words In this operation manual, AADANGER, ZAWARNING, A\CAUTION and CAUTION are signal words used to indicate safety and other important instructions. The signal words and their meanings are defined as follow. Please understand their meanings ; Po z = a dion PT | _A\__ | ‘attention’ (Please refer to the operation manual.) 3. Safety precautions Please read the following precautions carefully to ensure the safety of the patient and the operator when using this transducer. A\DANGER: Do not operate this transducer in an atmosphere containing flammable or explosive gases such as anesthetic gases, oxygen, and hydrogen because an explosion may occur. 83ZXWARNING: 4. Confirm that the transducer and cable are normal before and after each examination. A defective transducer may cause electric shock to the patient. 2. Do not subject the transducer to shock. A defective transducer may cause electric shock to the patient. 3. Do not disassemble the transducer to avoid the possibility of electric shock. Never immerse the transducer connector into liquids such as water or disinfectant because the connector is not waterproof. Immersion may cause electric shock or malfunction. 5, Precautions related to biopsy procedures (Optional accessory): (4) The person performing biopsy procedures must understand diagnostic ultrasound thoroughly and have been trained adequate, or various side effects may be caused in the patient. (2) In situations listed below, the biopsy needle may fail to penetrate the target. This type of incorrect biopsy may cause various side effects in the patient. * Uses a needle-guided bracket other than that provided. * Mounts the needle-guided bracket incorrectly. * Uses a biopsy needle that is unsuitable for the type of biopsy being performed. * Uses a biopsy needle that is unsuitable for the needle guide. (3) Before and after a biopsy procedure is performed, confirm that the needle-guided bracket is normal, Manually confirm that the parts of the needle-guided bracket do not slip off or move from their proper positions. If the bracket is used when parts are not securely and correctly installed, the patient may be injured. (4) Do not use a needle-guided bracket when scanning is performed. The needle may advance in an incorrect direction and possibly injure the patient. s4A\WARNIN' * No needle-guided brackets for scanning are available. (5) During biopsy procedures, the needle may deviate from the desired course due to the tissue characteristics or the type of needle. In particular, needles with small diameters may deviate to a greater degree. When performing biopsy procedures, take care to monitor the target region and the tip of the needle always. (6) Disinfect the transducer and ster the needle-guided bracket before and after each ultrasound-guided biopsy procedure is performed. Failure to do so may result in the transducer and the bracket becoming sources of infection. (D The needle mark displayed on the ultrasound image does not indicate the actual position of the biopsy needle. Therefore it should only be used as a reference. (For the operating procedure for the needle mark, please refer to the operation manual for the diagnostic ultrasound system.) is performed, ig biopsy procedures, use only sterile ultrasound gel that is certified to be safe. Also, manage the ultrasound gel properly to ensure that it does not become a source of infection. 6. This MINDRAY ultrasonic transducer is designed for use with MINDRAY ultrasound systems, Acautio! 4. When using this transducer MINDRAY recommend sterile gloves to prevent infection. 2. Be sure to use ultrasound gel. Do not use an ultrasound gel that does not list water as the principle ingredient. If castor oil is used, the transducer may deteriorate, possibly causing electric shock. 3. In normal diagnostic ultrasound mode, there is no danger of a low- temperature burn; however, keeping the transducer on the same region of the patient may cause such a burn. ssAXCAUTION: 4, Do not use the carrying case for storing the transducer. If the carrying case is used for storage, it may become a source of infection. 5. Image of the biopsy target and the actual position of the biopsy needle (Optional accessory) Even though the biopsy needle appears to have penetrated the target ae caused by dispersion of the ultrasound beam. Be particularly careful when object ‘age, it may not have actually done so. This problem is the target for biopsy is small. * Diagnostic ultrasound systems produce tomographic plane images with a finite thickness in the width direction of the transducer. If the target object and the biopsy needle appear in the image as shown in figure 1, they may be positioned in the beam as shown in figure 2. | Transducer \ a | Biopsy needle Ye Uttrasound Target object Target eam object Figure 1 The biopsy needle appears to Figure 2 Dispersion of the reach the target object in the image ultrasound beam To minimize this problem, note points below: (1) Do not rely only on the echo of the needle tip on the image. Pay careful attention to the target object, which should shift slightly when the biopsy needle comes into contact with it. (2) Perform biopsy only after confirming the size of the object to be psied and the probable success of biopsy. 6. Itis required to practice ALARA when operating ultrasound system. acoustic power ing. the precondition of appropriate ultrasonic a 86CAUTION: 1, Read following precautions to prevent the transducer from malfunction. (1) Before connecting or disconnecting the transducer, freeze or turn off the diagnostic ultrasound system. (2) Clean and disinfect the transducer before and after each examination. 2, Ambient conditions (1) To prevent the transducer from being damaged, do not use it where it will be exposed to: + direct sunlight or X-rays * sudden changes in temperature + dust + excessive vibration + heat generators (2) Use the transducer under following ambient conditions: + Ambient temperature : 5° C to 40° C + Relative humidity: 35% to 85% (no condensation) + Atmospheric pressure: 700hPa to 1060hPa 3. Repeated disinfection will eventually damage the transducer. Minimize disinfection4. Labels Various labels are attached to this device in order to call the user's attention. This operation manual describes the safety precautions of operating the transducer. Read the operation manual carefully before using the system. ‘Some labels are shown in the following. No. Label Meaning <> a Indicates the direction of the lock handle. The left corresponds to opening the lock handle, the right corresponds to locking the lock handle. <> ‘TYPE BF APPLIED PART. <> Indicates safety precautions. The label uses the same signal words as used in the descriptions in the operation manual. ssContents Chapter 1 Overview .... 1.1 Safety Classification 4.2 Applications. 1.3 Acoustic Power... 1.4 Composition 1.4.1 Name and Function of Each Part of the Transducer... 1.5 Optional accessory. Chapter 2 Connection to the Diagnostic Ultrasound System 2.4 Conneeting the Transducer... 2.2 Disconnecting the Transducer. Chapter 3 Inspection Before and After Use. 3.1 Check the External Appearance of the Transducer. 3.2 Cleaning the Transducer. 3.3 Check After Turning ON the System Chapter 4 Operating Procedures 4.1 Orientation of the Ultrasound Image and the Transducer Head... 4.2 Examinations.. 4.3 After Examinations... Chapter 5 Using Needle-guided brackets (Optional accessory)... 5.1 Names of Parts 5-4 5.2 Inspection of the Needle-guided bracket... 5A 5.3 Installing the Needle-guided bracket. 5-4 5.4 Adjusting the needle mark.. 55 5.5 Biopsy Procedures... 5-5 5.6 Clean and Sterilize the Needle-guided Bracket..... Chapter 6 Cleaning and Disinfection.. 6.1 Cleaning. co6.2 High Level Disinfection. Chapter 7 Storage and Transportation.. Chapter 8 Specifications .. c2Chapter 1 Overview 1.1 Safety Classification Please refer to the safety classification information in the operation manual of the diagnostic ultrasound system that is suitable for this transducer. 1.2 Applications Please check the operation manual for the diagnostic ultrasound system to check the compatibility of this transducer. This transducer is designed for imaging organs, localizing lesions, and mapping in diagnostic ultrasound. Applicable organs and methods of application are listed in the following table. ‘Abdomen testing 1.3. Acoustic Power The effects of acoustic power on human tissue are currently under investigation. Therefore, it is recommended that diagnostic ultrasound output power be set to the lowest possible levels in accordance with the principle of ALARA (As Low As Reasonably Achievable). Please refer to the operation manual of the diagnostic ultrasound system. 1.4 Composition The following items are supplied with this transducer. Ultrasonic transducer Operation manual Carrying caseOverview Figure 1-1 Ultrasonic transducer 35C50EB ,Operation manual ,Carrying case 1.4.1 Name and Function of Each Part of the Transducer This section describes the name and function of each section as well as the immersible range of the ultrasonic transducer. This transducer is classified as "IPX7" according to the degree of protection against harmful ingress of water. The connector section is not waterproof and must not be immersed into liquids such as disinfectant. Figure 1-2 Name and Function of Each Part of the Transducer <1> Transducer head: Itutiizes the piezoelectric effect to convert electrical signals into ultrasound waves, Which are transmitted to the body, and to generate electrical signals when receiving the reflected ultrasound waves (echoes) The lens on the surface is the acousticOverview lens. Apply ultrasound gel on the acoustic. lens. <2> Needle-guided bracket fix tabs: Mount the needle-guided bracket using these tabs. <3> Cable: This transmits electrical signals between the transducer body and connector. Connector: This connects the transducer to the diagnostic ultrasound system. <5> Lock handle: This locks the connector to the diagnostic ultrasound system. 1.5 Optional accessory A needle-guided bracket is available for purchase as an optional accessory; it is used in combination with this transducer. To order needle-guided brackets, contact your MINDRAY representative. 35C50EB NGB-001 13G, 156, 16G, 186, 206 For biopsy or treatment, ultrasound-guided biopsy procedures can be performed using this transducer in combination with a needle-guided bracket (optional accessory) and a biopsy needle (provided by the user).Chapter 2 Connection to the Diagnostic Ultrasound System This tansducer can be used in combination with compatible diagnostic ultrasound systems. CAUTION: Before connecting or disconnecting a transducer, freeze or turn off the ultrasound system. If a transducer is connected or disconnected while it is selected, the diagnostic ultrasound system or the transducer may malfunction. 2.1 Connecting the Transducer After freezing or turing off the diagnostic ultrasound system, insert the connector into the transducer connector slot of the diagnostic ultrasound system, then turn the lock handle 90° clockwise to lock it securely. Figure 2-1 Connecting the Transducer 2.2 Disconnecting the Transducer After freezing or turning off the diagnostic ultrasound system, turn the lock handle90° anticlockwise to release it, and pull it out straight.Connection to the Diagnostic Ultrasound System Figure 2-2 Disconnecting the Transducer 22Chapter 3 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 your MINDRAY representative. 3.1 Check the External Appearance of the Transducer Confirm that there are no abnormalities of the transducer surface or cable sheath, such as Peeling, cracks, protruding parts, or flabbiness of the acoustic lens, before and after each ‘examination. AXWARNING: Transducer abnormalities may cause electric shock or injury to the patient. If any abnormality is found, immediately ‘stop using the transducer and contact your MINDRAY representative. 3.2 Cleaning the Transducer Clean and disinfect the transducer before and after each examination. A\cAuTION: The transducer without cleaning and disinfection may become a source of infection. 3.3 Check After Turning ON the System After turning ON the power of the diagnostic ultrasound system, perform the following checks. 1. The acoustic lens of the transducer must not generate abnormal heat while it is being used. The transducer temperature should be checked by touch. AXCAUTION: If the operator keeps a hot acoustic lens in contact the body surface, the patient may be burned. 31Inspection Before and After Use 2. The image must not be abnormal while turning on the system. AXCAUTION: ‘Any such occurrence means that the diagnostic ultrasound system or the transducer may be defective.Chapter 4 Operating Procedures 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. A\cAUTION: ‘When using the transducer, MINDRAY recommend sterile gloves to prevent infection. 4.1 Orientation of the Ultrasound Image and the Transducer Head ‘The orientation of the ultrasound image and transducer is shown below. The side pointed by arrow of the ultrasound image on the observation monitor corresponds to the O-mark side of the transducer. Check the orientation before the examination. mark Point to the mark side Figure 4-1 Orientation of the Ultrasound Image and the Transducer Head 41Operating Procedures 4.2 Examinations The operator should adopt relevant ultrasonic scanning procedures and methods according to different target organ. CAUTION : Itis required to practice ALARA when operating ultrasound system. It is also required to practice sterile principle when performing biopsy procedures. 4.3. After Examinations After the examination is completed, tum OFF the diagnostic ultrasound system and refer to chapter 6 "Cleaning and Disinfection”, After completing each examination, disinfect the transducer as necessary. When biopsy procedures have been performed, be sure to sterilize and the needle-guided bracket. Fail to do so may result in the transducer and the needle-guided bracket to becoming sources of infection. ‘After disinfecting the transducer, confirm that the transducer is in good condition and store itin a suitable place so that the next examination can be conducted smoothly. 42Chapter 5 Using Needle-guided brackets (Optional accessory) Please refer to section 1.5 to choose the needle-guided bracket. Biopsy procedures must be performed extremely carefully to prevent the induction of tissue necrosis, neurological disorders, infectious diseases, and other such problems. The linical examination technique should be determined after consultation with concerned specialists. AAWARNING: 1. The person performing biopsy procedures must understand diagnostic ultrasound thoroughly and have been trained adequate, or various side effects may be caused in the patient. 2. In situations listed below, the biopsy needle may fail to penetrate the target. This type of incorrect biopsy may cause various side effects in the patient. * Uses a needle-guided bracket other than that provided. * Mounts the needle-guided bracket incorrectly. * Uses a biopsy needle that is unsuitable for the type of biopsy being performed. * Uses a biopsy needle that is unsuitable for the needle guide. 3. Before and after a biopsy procedure is performed, confirm that the needle-guided bracket is normal. Manually confirm that the parts of the led bracket do not slip off or move from their proper positions. If needle-g the needle-guided bracket is used when parts are not securely and correctly installed, the patient may be injured. 4. Do not use a needle-guided bracket when scanning is performed. The needle may advance in an incorrect direction and possibly i nt. jure the pat * No needle-guided brackets for scanning are available. 5. During biopsy procedures, the needle may deviate from the desired course due to the tissue characteristics or the type of needle. In particular, needles. with small diameters may deviate to a greater degree. When perfor and the tip of the needle always. 1g biopsy procedures, take care to monitor the target region SUsing Needle-guidded brackets (Optional accessory) sh AAWARNING: 6. Disinfect the transducer and sterilize the needle-guided bracket before and after each ultrasound-guided biopsy procedure is performed. Failure to do so ‘may result in the transducer and the needle-guided bracket becoming sources of infection. 7. The needle mark displayed on the ultrasound image does not indicate the le, Therefore it should only be used as a actual position of the biopsy net reference. (For the operating procedure for the needle mark, please refer to the operation manual for the diagnostic ultrasound system.) 8, Adjust the needle mark before the biopsy procedure is performed. 9. When performing biopsy procedures, use only sterile ultrasound gel that is, certified to be safe. Also, manage the ultrasound gel properly to ensure that it does not become a source of infection. 10. When perfor the operation concerning AXCAUTION: Even though the biopsy needle appears to have penetrated the target object in the image, it may not actually have done so. is problem is caused by dispersion of the ultrasound beam. Be particularly careful when the target for biopsy is small. gnostic ultrasound systems produce tomographic plane images with a ite thickness in the width direction of the transducer. If the target object and the biopsy needle appear in the image as shown in figure 5-1, they may be positioned in the beam as shown in figure 5-2. 52Using Needle-guided brackets (Optional accessory) A.cAUTION: ‘Transducer \ \ [— : < A Biopsy noodle 2 needle Target Ultrasound Target object beam object Figure 5-1 The biopsy needle appears to Figure 5-2 Dispersion of the reach the target object in the image ultrasound beam The biopsy needle may not have actually entered the target object even though it appears to have done so on the image. To minimize this problem, note points below: (1) Do not rely only on the echo of the needle tip on the image. Pay careful attention to the target object, which should shift slightly when the biopsy needle comes into contact with it. (2) Perform biopsy only after confirming the size of the object to be biopsied and the probable success of biopsy. 33Using Needle-guided brackets (Optional accessory) 5.1 Names of Parts Clamping knob of theneedleguide Needieguide Needle guide hole Clamp Needle guide rack Locating groove Grip knob Figure 5-3 Names of parts 5.2 Inspection of the Needle-guided bracket Procedures for inspection of the needle-guided bracket are described below. Be sure to perform inspections before and after use. If an abnormality is found on the needle-guided bracket, immediately stop using it and contact your MINDRAY representative. 4. Sterilize the needle-guided bracket before and after use. 2. Confirm that the needle-guided bracket is free of damage, deformation, stripping, matfunetion, or loose or missing parts. 3. Confirm that the needle-guided bracket is securely mounted in the correct position. 5.3 Installing the Needle-guided bracket 4. Inosculate the locating groove on the clamp with the two raised edges on the transducer and aligning the locating pit of the clamp to the convex point on the transducer. 2. Turn the grip knob at the tail of the needle-guided bracket tightly. 3. Thread the needle guide through the guide hole of the needle guide rack; turn the clamping knob of the needle guide to fasten the needle guide. 54Using Needle-guided brackets (Optional accessory) Figure 5-4 Installing the needle-guided bracket 5.4 Adjusting the needle mark ‘Adjusting the needle mark is necessary before every biopsy procedure. 1. Confirm that the needle-guided bracket have been installed securely in the correct. Position. 2. Prepare a container of sterile water. 3. Place the head of the transducer in the sterile water, and get a biopsy needle into the needle guide, 4. When the biopsy needle appears on the image, confirm that the biopsy needle is displayed at almost the same position as the selected needle mark. 5.5 Biopsy Procedures 1. The needle mark is displayed on the screen and the number on the right side of the ‘menu show current state of the needle mark. 2. Align the needle mark with the region to be biopsied. 3. Insert the needle into the target object. 4, After extraction of the biopsy sample is completed, gently extract the transducer from the body. 5.6 Clean and Sterilize the Needle-guided Bracket AAWARNING: Clean and sterilize the needle-guided bracket before and after use. 58Using Needle-guided brackets (Optional accessory) 5.6.1 Cleaning 1, Wear sterile gloves to prevent infection. 2. Wash the needie-guided bracket with water and remove all foreign matter. Soapy water may be used. A soft urethane sponge can be used to wash the needle-guided bracket. Avoid using a brush, because it may damage the needle-guided bracket 3. Wipe off water on the needle-guided bracket using sterile cloth or gauze after washing it. Do not dry the needle-guided bracket by heating, 5.6.2 Sterilization 4. Wear sterile gloves to prevent infection, 2. Clean the needle-guided bracket before sterilizing it. The transducer manufacturer recommend the following solution to sterilize the needle-guided bracket. Please follow manufacturer's sterilization instructions. It may require 10 hours Dialdehyde Solution | submersion at 25°C. Glutaraldehyde (2.4%) © Refer to the instructions of chemical manufacturer concerning concentration of the sterilization solution, method of sterilization and dilution. © Note that glutaraldehyde sterilization solutions need an activating solution. 3. Remove all chemical residues on the needle-guided bracket by rinsing thoroughly with sterile water. 4. Wipe off water on the needie-guided bracket using sterile cloth or gauze after washing it, Do not dry the needle-guided bracket by heating. 56Chapter 6 Cleaning and Disinfection This section describes the methods and precautions for cleaning and disinfecting the transducer. A\WARNING: Never immerse the transducer connector into li ids such as water or disinfectant. Immersion may cause electrical shock or malfunction, AXCAUTION: 4. When cleaning and infecting the transducer, wear sterile gloves. 2. After disinfection, rinse the transducer thoroughly with sterile water to remove all chemical residues. Chemical residues on the transducer may be harmful to the human body. 3. The efficacy of fectants and sterilizing solutions is not guaranteed by MINDRAY. Contact the manufacturers for information on the acti products. ee CAUTION: 1. After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the of the ultrasound gel may solidify and the image quality would be degraded. 2. Do not permit the transducer to become overheated (more than 55°C) during Cleaning and disinfection. High temperature may cause the transducer to become deformed or damaged. 61Cleaning and Disinfection 6.1 Cleaning 1. Wear sterile gloves to prevent infection. 2. Wash the transducer with water and remove all foreign matter. Soapy water may be used. A soft urethane sponge can be used to wash the transducer. Avoid using a brush, because it may damage the transducer. 3. Wipe off water on the transducer using sterile cloth or gauze after washing it. Do not dry the transducer by heating. 6.2 High Level Disinfections 4, Wear sterile gloves to prevent infection. 2. Clean the transducer before disinfecting it. The transducer manufacturer recommend the following solution to disinfect the transducer. Please follow manufacturer's disinfection instructions. It may require 45 minutes submersion at 25°C. Glutaraldehyde (2.4%) Dialdehyde Solution ‘© Refer to the instructions of chemical manufacturer concerning concentration of the disinfectant solution, method of disinfection and dilution. © Note that glutaraldehyde disinfectant solutions need an activating solution. 3, Remove all chemical residues on the transducer by rinsing thoroughly with sterile water. 4. Wipe off water on the transducer using sterile cloth or gauze after washing it. Do not, ‘dry the transducer by heating. 62Cleaning and Disinfection Figure 6-1 Immerse the transducer in the solution CAUTION: 1. The lens may be discolored, the label on the transducer may fade. These are not abnormalities. 2. Repeated disinfection will eventually damage the transducer. Minimize disinfection, 63Chapter 7 Storage and Transportation 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. 1. To prevent the transducer from being damaged, do not store it in locations where it may be exposed to: + direct sunlight or X-rays + sudden changes in temperature + dust + excessive vibration * heat generators 2. Store or transport the transducer under following ambient conditions: + Ambient temperature : -20° C to 55°C + Relative humidity: 30% to 85% (no condensation) + Atmospheric pressure: 700hPa to 1060hPa 3. When the transducer is sent to your MINDRAY representative for repair, be sure to disinfect it and keep it in the carrying case to prevent infection. 4, Sterilize the carrying case as necessary. rHChapter 8 Specifications ‘The specifications of this transducer are listed below. 35C50EB 2260: 50mm, 35% to 85% (no condensation) 70OhPa to 1060hPa 1PIN: PR2B-20-16210 (V1.1)