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Summary of Contents for FujiFilm PB2020-M
- Page 1 English Endoscopic Ultrasonic Probe OPERATION MANUAL PB2020-M Thank you for purchasing our product. Read this manual carefully before use to avoid unexpected accidents and take full advantage of the product’s capabilities. 202B1263042...
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Page 3: Introduction
The medical endoscopic ultrasonic probe PB2020-M is intended for ultrasonographic observation and diagnosis of the trachea, bronchus, esophagus, stomach, duodenum, and large intestine via the instrument channel of a FUJIFILM endoscope in medical facilities under the management of a physician. Do not use this product for any other purpose. - Page 4 FUJIFILM Corporation. FUJIFILM Corporation shall not be liable for malfunctions and damages of FUJIFILM Corporation products due to products of other manufacturers not supplied by FUJIFILM Corporation.
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Page 5: How To Read This Manual
How to Read This Manual How to Read This Manual Conventions Used in This Manual This manual uses the following conventions for easier understanding. General Conventions Convention Description Indicates a potential danger that may cause harm to people. Explains dangerous situations that may cause death or WARNING serious injury if not avoided. -
Page 6: Contents At A Glance
Contents at a Glance Contents at a Glance Chapter 1 Precautions This chapter describes the warnings and cautions for safe operation of this product. Chapter 2 Names and Functions of Parts This chapter describes the names and functions of this product. Chapter 3 Inspection Before Use This chapter describes the inspection to be performed for using this... -
Page 7: Table Of Contents
Contents Contents Introduction ....................... 3 How to Read This Manual ..................5 Contents at a Glance ....................6 Chapter 1 Precautions ..................... 9 1.1 For Safe Operation ................. 9 1.2 Classification .................. 9 1.3 Safety ................... 10 1.3.1 Infection ................10 1.3.2 Preventing Electrical Shock .......... - Page 8 Contents Chapter 6 Chemical Disinfection ................43 6.1 Method of Chemical Disinfection ..........43 6.2 Disinfectant Solution ..............44 6.3 Chemical Disinfection of Endoscopic Ultrasonic Probe ....45 6.4 Rinsing of Endoscopic Ultrasonic Probe After Disinfection ..47 6.5 Rinsing of Endoscopic Ultrasonic Probe After Disinfection ..48 Chapter 7 Sterilization ...................49 7.1 Methods of Sterilization ..............
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Page 9: Chapter 1 Precautions
Do not modify this product or its components, and do not disassemble, repair or in any other way reverse-engineer these products. Even if you find a defect, do not attempt to repair these products yourself. FUJIFILM Corporation shall not be liable for any defects or device failures caused by such modifications, disassembly, repairs or reverse-engineering. -
Page 10: Safety
Chapter 1 Precautions 1.3 Safety Read the following precautions before using this product to ensure proper handling. 1.3.1 Infection WARNING This product has not been cleaned or disinfected (or sterilized). It must be cleaned and disinfected (or sterilized) for the first time prior to use and after any subsequent use as per instructions provided in this manual. - Page 11 Chapter 1 Precautions WARNING Be sure to wear sterile gloves when inspecting this product. Not doing so may contaminate this product and pose an infection risk. In clinical procedures in which this product that has been sterilized is used, exercise caution not to contaminate this product when placing it temporarily.
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Page 12: Preventing Electrical Shock
Chapter 1 Precautions WARNING After cleaning, rinse off any remaining detergent solution with clean water. If detergent solution remains, the chemical disinfection to be performed at the next step will lose its effectiveness. After immersing this product in disinfectant solution, remove air bubbles completely. -
Page 13: Direct Harm To Human Body
Chapter 1 Precautions 1.3.3 Direct Harm to Human Body WARNING To avoid the potential for patient injury including perforation and bleeding, do not apply excessive force of this product against walls of the bronchus and digestive tract. Only advance this product under direct visualization. When using this product for an endoscope with two instrumaent channels, do not use an electrosurgical unit at the same time. - Page 14 Chapter 1 Precautions CAUTION Clean and disinfect (or sterilize) this product in a clean environment. If dust adheres to this product after cleaning and disinfection (or sterilization), it may enter the patient's body. After cleaning, rinse off any remaining detergent solution with water. If detergent solution remains, chemicals to be used in the subsequent steps may be diluted or adulterated.
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Page 15: Electromagnetic Compatibility (Emc)
• Consult the manufacturer or dealer of other devices. If the problem cannot be solved with the above measures, stop using this product and consult the manufacturer or your local FUJIFILM dealer for help. WARNING Do not place any objects that emit strong electromagnetic waves near this product. -
Page 16: Location Of Each Label
Chapter 1 Precautions 1.5 Location of Each Label The position where the label is affixed on this product is shown below. The relevant safety signs are also described. 1.5.1 Location of Label Model Label 202B1263042... -
Page 17: Symbols
Chapter 1 Precautions 1.5.2 Symbols Symbol Description Serial number Date of manufacture Manufacturer Authorised representative in the European Community Refer to instructions for use (Blue) Temperature limitation Keep dry CE marking Degree of waterproof Type BF applied part [Note] WEEE marking Humidity limitation Atmospheric pressure limitation Quantity... -
Page 18: Possible Combinations For Use
Chapter 1 Precautions 1.6 Possible Combinations for Use 1.6.1 Peripheral Devices WARNING We recommend use of only those peripheral products specified in this manual. Read the operation manuals of the peripheral devices used in combination with this product. 202B1263042... -
Page 19: Cautions/Warnings
Chapter 1 Precautions 1.7 Cautions/Warnings Observe the following cautions when handling this product. Also, there are same cautions in each chapter. CAUTION Do not use this product if it has failed its pre-inspection check. Doing so can negatively affect the functionality of the instrument or increase risks to patient safety. -
Page 20: General Warnings
Chapter 1 Precautions CAUTION Do not store this product in a place which does not meet the storage conditions. Doing so may cause equipment failure. 1.7.3 General Warnings WARNING Make sure to inspect the equipment before use according to the procedures provided in this manual to avoid unexpected accidents and to take full advantage of the equipment’s capabilities. -
Page 21: Chapter 2 Product Overview
Chapter 2 Product Overview Chapter 2 Product Overview 2.1 Components of This Product This products consists of the following components. Figures in parentheses indicate the number of articles. Endoscopic Ultrasonic Probe Operation Manual (1) PB2020-M (1) 202B1263042... -
Page 22: Names And Function Of Parts
Chapter 2 Product Overview 2.2 Names and Function of Parts This section describes the names and functions of this product. 5. Insertion portion (applied part) 3. Model label 2. Probe code 4. Boot 1. Probe connector 8. End holder 6. Ultrasound head 7. -
Page 23: Chapter 3 Inspection Before Use
Chapter 3 Inspection Before Use Chapter 3 Inspection Before Use WARNING Be sure to wear sterile gloves when inspecting this product. Not doing so may contaminate this product and pose an infection risk. In clinical procedures in which this product that has been sterilized is used, exercise caution not to contaminate this product when placing it temporarily. -
Page 24: Inspecting Endoscopic Ultrasonic Probe
Chapter 3 Inspection Before Use 3.1 Inspecting Endoscopic Ultrasonic Probe (1) Visually or manually check the external appearance of this product and the probe connector to make sure that they are free from abnormalities such as cracks, starches, and dents, as well as sharp edges and protrusions that may injure the patient. -
Page 25: Removing Air Bubbles
FUJIFILM dealer. (3) H o l d t h e e n d o s c o p i c u l t r a s o n i c p r o b e... - Page 26 Chapter 3 Inspection Before Use (4) Once air bubbles are removed, keep the endoscopic ultrasonic probe's distal end downward. 202B1263042...
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Page 27: Inspecting For Combination
Chapter 3 Inspection Before Use 3.3 Inspecting for Combination CAUTION Do not detach the endoscopic ultrasonic probe from the prove drive unit while freeze mode is disabled (the transducer is rotating). Doing so may cause equipment failure of the endoscopic ultrasonic probe or the prove drive unit. - Page 28 Chapter 3 Inspection Before Use (4) Press the [FREEZE] key on the keyboard of the ultrasonic processor to disable freeze mode. Make sure that the transducer of the ultrasound head is rotating and that a multiple-echo image appears on the monitor. [Note] Make also sure that the insertion portion and other components function normally and do not...
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Page 29: Chapter 4 Method Of Use
Chapter 4 Method of Use Chapter 4 Method of Use This chapter outlines how to operate the equipment, according to the general procedures. This manual does not provide information about clinical procedures. Users should exercise proper clinical judgment. WARNING Slowly insert this product straight into the endoscope. Also, when withdrawing it, slowly pull straight out. -
Page 30: Inserting Endoscopic Ultrasonic Probe And Performing Ultrasound Examination
Chapter 4 Method of Use 4.1 Inserting Endoscopic Ultrasonic Probe and Performing Ultrasound Examination WARNING If the image often becomes dark during observation, air bubbles may be on the transducer inside the ultrasound head. However, do not remove air bubbles once this product is inserted. Body fluid adhered to this product may be splattered, posing an infection risk. - Page 31 Chapter 4 Method of Use CAUTION Do not push or pull this product or insert into the bending portion of an endoscope when this product is operating (freeze mode is disabled). If the endoscope is bent excessively or the forceps stand is moved up, slowly push or pull this product.
- Page 32 Chapter 4 Method of Use (4) Insert the endoscopic ultrasonic probe into the forceps inlet of an endoscope with the forceps valve on. [Note] Open the lid of the forceps valve before insertion. (5) Insert the endoscopic ultrasonic probe up to a position where the ultrasound head is visible in the endoscopic image.
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Page 33: Withdrawal Of Endoscopic Ultrasonic Probe
Chapter 4 Method of Use 4.2 Withdrawal of Endoscopic Ultrasonic Probe WARNING Do not withdraw this product sharply. In so doing, body fluids adhered to this product may be splattered, posing an infection risk. CAUTION When withdrawing this product, be sure to press the [FREEZE] key on the ultrasonic processor to enable freeze mode. - Page 34 Chapter 4 Method of Use (4) Withdraw the endoscopic ultrasonic probe from the endoscope. [Note] Wipe the dirt on the endoscopic ultrasonic probe's insertion portion with a paper towel (or gauze). [Note] Insert the insertion portion of the endoscopic ultrasonic probe through the end holder so as to keep the ultrasound head and insertion portion from touching the floor.
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Page 35: Chapter 5 Cleaning
Chapter 5 Cleaning Chapter 5 Cleaning This chapter explains how to clean this product. Pre-cleaning is performed at the bedside immediately after an examination is completed. Manual cleaning is performed in a sink, etc. after pre-cleaning. WARNING This product is not compatible with cleaning and disinfection with an automated endoscope reprocessor. -
Page 36: Detergent Solution
For the names of specific brands of detergent solution that have been tested for compatibility with this product, contact your local FUJIFILM dealer. Refer to the detergent solution manufacturer's instructions for preparation and use. -
Page 37: Necessary Equipment And Materials
Chapter 5 Cleaning 5.3 Necessary Equipment and Materials Prepare the necessary equipments used in Chapter 5 “Cleaning” and Chapter 6 “Disinfection.” • Sterile gauze • Toothbrush (soft type) • Detergent solution/disinfectant solution • Container for detergent solution/disinfectant solution • Personal protective equipment Rubber gloves Goggle Facemask... -
Page 38: Pre-Cleaning
Chapter 5 Cleaning 5.4 Pre-cleaning Perform pre-cleaning at the bedside immediately after an examination is completed. 5.4.1 Wiping (1) Wipe the dirt on the external surfaces of this product's insertion portion with gauze or a paper towel. Gauze dampened with ethanol may also be used when required. -
Page 39: Manual Cleaning
Chapter 5 Cleaning 5.5 Manual Cleaning Perform manual cleaning in a sink, etc. after pre-cleaning. Manual cleaning must be performed immediately after pre-cleaning is completed. 5.5.1 Cleaning of Endoscopic Ultrasonic Probe (1) A t t a c h t h e c o n n e c t o r c a p t o t h e p r o b e connector. - Page 40 Chapter 5 Cleaning (5) Clean the external surface (insertion portion, b o o t , p r o b e c o n n e c t o r , e n d h o l d e r a n d connector cap) of the endoscopic ultrasonic probe with clean gauze in detergent solution.
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Page 41: Rinsing Of Endoscopic Ultrasonic Probe
Chapter 5 Cleaning 5.5.2 Rinsing of Endoscopic Ultrasonic Probe WARNING After cleaning, rinse off any remaining detergent solution with clean water. If detergent solution remains, disinfection to be performed at the next step will lose its effectiveness. CAUTION After cleaning, rinse off any remaining detergent solution with water. If detergent solution remains, chemicals to be used in the subsequent steps may be diluted or adulterated. - Page 42 Chapter 5 Cleaning (4) Remove the endoscopic ultrasonic probe from clean water and transfer it to a clean basin. (5) Wipe any clean water remaining on the external surface of the endoscopic ultrasonic probe with clean lint-free gauze. (6) Detach the connector cap from the probe connector.
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Page 43: Chapter 6 Chemical Disinfection
Chapter 6 Chemical Disinfection Chapter 6 Chemical Disinfection This chapter explains how to perform chemical disinfection. Perform chemical disinfection after pre-cleaning and manual cleaning. WARNING When immersing this product in disinfectant solution, immerse the entire unit. If not properly immersed, effective chemical disinfection cannot be achieved. -
Page 44: Disinfectant Solution
3.5% glutaraldehyde disinfectant solutions has been verified. Use glutaraldehyde disinfectant solutions in accordance with the manufacturer’s instructions. For the names of specific brands of disinfectant solution, contact your local FUJIFILM dealer. [Note] Refer to the disinfectant solution manufacturer’s instructions regarding preparation, use, exposure conditions and expiration date. -
Page 45: Chemical Disinfection Of Endoscopic Ultrasonic Probe
Chapter 6 Chemical Disinfection 6.3 Chemical Disinfection of Endoscopic Ultrasonic Probe (1) A t t a c h t h e c o n n e c t o r c a p t o t h e p r o b e connector. - Page 46 Chapter 6 Chemical Disinfection (6) Using a syringe, flush 60 mL of disinfectant solution onto each gap and recess of the probe connector to remove air bubbles completely. (7) Keep the endoscopic ultrasonic probe immersed in the disinfectant solution at the temperature, concentration and time recommended by the disinfectant solution's manufacturer.
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Page 47: Rinsing Of Endoscopic Ultrasonic Probe After Disinfection
Chapter 6 Chemical Disinfection 6.4 Rinsing of Endoscopic Ultrasonic Probe After Disinfection (1) Fill a sterile basin with sterile water. (2) Fully immerse the endoscopic ultrasonic probe in sterile water. (3) Wipe the external surface (insertion portion, b o o t , p r o b e c o n n e c t o r , e n d h o l d e r a n d connector cap) of the endoscopic ultrasonic probe with sterile gauze in sterile water to remove air bubbles completely. -
Page 48: Rinsing Of Endoscopic Ultrasonic Probe After Disinfection
Chapter 6 Chemical Disinfection 6.5 Rinsing of Endoscopic Ultrasonic Probe After Disinfection (1) Wipe any sterile water remaining on the external surface of the endoscopic ultrasonic probe with sterile gauze. (2) Detach the connector cap from the probe connector. (3) Wipe the end of the probe connector with sterile gauze. -
Page 49: Chapter 7 Sterilization
Chapter 7 Sterilization Chapter 7 Sterilization This chapter explains how to sterilize this product. Perform ethylene oxide gas sterilization for this product. This product can withstand up to 30 times of ethylene oxide gas sterilization. Ethylene oxide gas sterilization applies more load to this product than chemical cleaning and disinfection, and reduces the product life. -
Page 50: Ethylene Oxide Gas Sterilization
Chapter 7 Sterilization 7.2 Ethylene Oxide Gas Sterilization WARNING When performing ethylene oxide gas sterilization of this product, ensure that the surfaces are dry before attempting ethylene oxide gas sterilization. If any moisture remains in this product, sterilization of undried parts will be incomplete and it could be a source of infection. -
Page 51: Eog (Ethylene Oxide Gas) Sterilization
Chapter 7 Sterilization 7.3 EOG (Ethylene Oxide Gas) Sterilization (1) Ensure that this product is completely dry, and then detach the connector cap from the probe connector. (2) Put this product in a sterile pack, and then seal the pack tightly. Place it in an EOG sterilizer. (3) Sterilize this product according to the operating procedure of the EOG sterilizer. -
Page 52: Chapter 8 Storage
Chapter 8 Storage Chapter 8 Storage WARNING Do not store this product in a packaging box. Doing so may cause infection. CAUTION Do not store this product in locations that do not satisfy storage conditions. Otherwise, a failure may result. Store the endoscopic ultrasonic probe that has been disinfected in a location that meets the following conditions. -
Page 53: Main Specification
Main Specification Main Specification <Classification of Medical Electrical Equipment> 1. Type of protection against electric shock : Class I equipment (power supply: protective earth plug) 2. Degree of protection against electric shock : Type BF applied part 3. Degree of explosion protection : Use is prohibited in an oxygen-rich environment or in a flammable gas atmosphere. - Page 54 Main Specification <Peripheral Devices> Compatible ultrasonic processor SP-900 [Note] Bronchoscope [Note] Upper gastrointestinal endoscope Compatible endoscope [Note] Large intestine endoscope [Note] Duodenoscope [Note] The channel diameter of each endoscope must be 2.0 mm or more and the working length 1330 mm or less. <Operating Environment>...
- Page 55 Main Specification <Electromagnetic Compatibility (EMC) Information> This product is intended for use in the electromagnetic environments specified below. The customer or the user of this product should assure that it is used in such an environment. [Note] Use in combination with the SP-900 ultrasonic processor. Electromagnetic emission compliance information and guidance Emission standard Compliance...
- Page 56 Main Specification Electromagnetic immunity compliance information and guidance EN 60601-1-2 Compliance Immunity test Guidance Test level level Floors should be wood, concrete, Electrostatic discharge or ceramic tile. If floors are ± 6kV: contact Same as (ESD) covered with synthetic material, ±...
- Page 57 Main Specification Electromagnetic immunity compliance information and guidance EN 60601-1-2 Compliance Immunity test Guidance Test level level Portable and mobile RF communications equipment should be used no closer to any part of this product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of transmitter.
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Page 58: Disposal Of Electric And Electronic Equipment
The recycling of materials will help to conserve natural resources. For more detailed information about recycling of this product, contact your local FUJIFILM dealer. In Countries outside the EU: If you wish to discard this product, contact your local authorities and ask for the correct way of disposal. -
Page 59: Index
Index Index <A> After-sales service ........58 <C> CAUTION ............ 5 Chemical disinfection ........ 43 Cleaning ............ 35 Connector cap ........... 22 Conventions used in this manual ....5 <E> End holder ..........22 <I> Insertion portion ........22 Inspection ..........23 <L>... -
Page 60: Service Centers
Contact our regional representative below or the distributor from which you purchased the product. <Europe> FUJIFILM Europe GmbH http://www.fujifilm.eu/eu/ See our website to locate our representative in your country. <USA> Fujifilm Medical Systems U.S.A., Inc http://www.fujifilmendoscopy.com/ (800) 385-4666 <Australia> FUJIFILM Australia Pty Ltd. http://www.fujifilm.com.au/ 1800 060 209 <Asia>... - Page 61 Service Centers 202B1263042...
- Page 62 FUJIFILM Corporation 26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan FUJIFILM Europe GmbH Heesenstrasse 31, 40549 Duesseldorf, Germany 202B1263042 160316 - 1.0 - DT - E2 FU49A Printed in Japan...
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