PB2020-M Endoscopic Ultrasonic Probe Operational Manual



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Introduction

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. This manual provides necessary information for using the endoscopic ultrasonic probe, such as the equipment overview, operation procedures and precautions to observe, as well as the cleaning, disinfection and storage methods. If you are a first-time user of this product, be sure to read this manual before actual operation. Also, after reading this manual, store it close to this product for future reference to keep the product in optimum working condition.

Trademarks The company names and product names described in this manual are trademarks or registered trademarks of FUJIFILM Corporation or its subsidiaries. Other holders’ trademarks All other company names and product names described in this manual are trademarks or registered trademarks of their respective owners. Copyright © 2016 FUJIFILM Corporation. All rights reserved.

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Introduction

CAUTION 1 2 3

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No part or all of this manual may be reproduced in any form without prior permission. The information contained in this manual may be subject to change without prior notice. FUJIFILM Corporation shall not be liable for malfunctions and damages caused by installation, relocation, remodeling, maintenance, and repair performed by dealers other than those specified by 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. FUJIFILM Corporation shall not be liable for malfunctions and damages caused by remodeling, maintenance, and repair using repair parts other than those specified by FUJIFILM Corporation. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from negligence of the precautions and operating methods contained in this manual. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from use under environment conditions outside the range specified for this product, such as the power supply, installation environment, etc., as described in this manual. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from natural disasters, such as fires, earthquakes, floods, lightning, etc.

This product has heavy metal parts. When disposing of this product, comply with local laws and regulations in your area. Determine whether or not the product is to be treated as a biohazard, then handle and dispose of accordingly. Before disposing of this product, perform cleaning and disinfection (or sterilization) according to the procedure described in this manual. There is a risk of being a source of infection.

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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.

WARNING

Explains dangerous situations that may cause death or serious injury if not avoided.

CAUTION

Explains situations that may cause injury if not avoided.

CAUTION

Explains situations that may cause damage to equipment if not avoided. Indicates consecutive numbers in operating procedures

(1), (2), (3), ... [Note]

for the order in which successive steps in the procedure should be taken. Indicates a comment or supplementary information. Indicates a reference.

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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 product.

Chapter 4

Method of Use

This chapter describes a series of operations of this product.

Chapter 5

Cleaning

This chapter describes the recommendations for cleaning of this product.

Chapter 6

Disinfection

This chapter describes the recommendations for disinfection of this product.

Chapter 7

Sterilization

This chapter describes the recommendations for sterilization of this product.

Chapter 8

Storage

This chapter describes the method and conditions of storage.

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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... 12 1.3.3 Direct Harm to Human Body... 13 1.4 Electromagnetic Compatibility (EMC)... 15 1.4.1 Electromagnetic Compatibility (EMC) Related Standard... 15 1.5 Location of Each Label... 16 1.5.1 Location of Label... 16 1.5.2 Symbols... 17 1.6 Possible Combinations for Use... 18 1.6.1 Peripheral Devices... 18 1.7 Cautions/Warnings... 19 1.7.1 Abnormalities During Use of This Product... 19 1.7.2 Transportation and Storage... 19 1.7.3 General Warnings... 20 Chapter 2 Product Overview...21 2.1 Components of This Product... 21 2.2 Names and Function of Parts... 22 Chapter 3 Inspection Before Use... 23 3.1 Inspecting Endoscopic Ultrasonic Probe... 24 3.2 Removing Air Bubbles... 25 3.3 Inspecting for Combination... 27 Chapter 4 Method of Use...29 4.1 Inserting Endoscopic Ultrasonic Probe and Performing Ultrasound Examination... 30 4.2 Withdrawal of Endoscopic Ultrasonic Probe... 33 Chapter 5 Cleaning... 35 5.1 Method of Cleaning... 35 5.2 Detergent Solution... 36 5.3 Necessary Equipment and Materials... 37 5.4 Pre-cleaning... 38 5.4.1 Wiping... 38 5.5 Manual Cleaning... 39 5.5.1 Cleaning of Endoscopic Ultrasonic Probe... 39 5.5.2 Rinsing of Endoscopic Ultrasonic Probe... 41 7

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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... 49 7.2 Ethylene Oxide Gas Sterilization... 50 7.3 EOG (Ethylene Oxide Gas) Sterilization... 51 Chapter 8 Storage... 52 Main Specification... 53 Disposal of Electric and Electronic Equipment... 58 Index... 59 Service Centers... 60

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Chapter 1 Precautions

Chapter 1 Precautions 1.1 For Safe Operation Before using this product, read this section carefully so that you can operate it correctly. Whenever you operate this product, be sure to observe those precautions. Failure to do so may cause you to subject to injuries or property damage to occur.

The institution is responsible for the use and maintenance of this product. In addition, this product should not be used by persons other than doctors or suitably trained staff.

Be sure to prepare a spare of this product against unexpected accidents such as the failure of this product. Otherwise, you may not be able to continue the endoscopic procedure. This product is intended for use by medical professionals who have received proper training in endoscopic procedures. This manual does not provide information about clinical procedures or any aspects of endoscopic techniques.

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.

1.2 Classification <Classification of Medical Electrical Equipment> 1. Type of protection against electric shock

: Class I equipment

(power supply: protected ground fault receptacle) 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. [Note] Use in combination with the SP-900 ultrasonic processor.

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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. Prior to reuse, this product must be pre-cleaned, cleaned and disinfected (or sterilized) according to the procedures given in this manual. Inadequate cleaning may compromise successful disinfection or sterilization, increasing the risk of infection. Meticulously clean all the surfaces of this product as per provided reprocessing instructions. Not doing so may pose an infection risk. Wear personal protective equipment (such as goggles, facemask, chemical-resistant and waterproof gloves, antifouling protective clothing, cap and shoe covers) during an examination and treatment as well as during reprocessing to protect your eye and skin and to prevent infection. Not doing so may cause infection. When using this product for a patient with Creutzfeldt-Jakob disease (especially variant Creutzfeldt-Jakob disease), use it exclusively for a patient with the same disease, or properly discard this product after use. Since the cleaning, disinfection and sterilization methods described in this manual cannot eliminate the causal agents of Creutzfeldt-Jakob disease, the product could be a source of infection. For the treatment of Creutzfeldt-Jakob disease, refer to local guidelines. Use a cleaned and disinfected (or sterilized) endoscopic ultrasonic probe. An inadequately cleaned and disinfected (or sterilized) probe may pose an infection risk. Carry a cleaned and disinfected (or sterilized) endoscopic ultrasonic probe at a clean state. If personal protective equipment such as gloves is contaminated, the contaminants adhere to this product and it can be a source of infection.

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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. Not doing so may pose an infection risk. Slowly insert this product straight into the endoscope. Also, when withdrawing it, slowly pull straight out. If it is inserted or withdrawn quickly, body fluid may be splattered around due to breakage or accidental detachment of the instrument, leading to infection. Slowly pull this product out of the end holder. If it is withdrawn quickly from the end holder, body fluid may be splattered around, posing an infection risk. Be sure to clean and disinfect (or sterilize) this product as per instructions as per instructions in this manual after every case. If this product is not disinfected (or sterilized), it may pose an infection risk or cause an accident. 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. Do not withdraw this product sharply. In so doing, body fluids adhered to this product may be splattered, posing an infection risk. This product is not compatible with cleaning and disinfection with an automated endoscope reprocessor. If an automated endoscope reprocessor is used, effective cleaning and disinfection cannot be achieved, and it may pose an infection risk. Excessive foaming prevents detergent solution from sufficiently contacting the surfaces and channel walls of the endoscope, and may impair effective cleaning. Do not reuse clean water and detergent solution that were used for cleaning. If reused, effective cleaning cannot be achieved, and it may pose an infection risk.

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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. If any air bubbles remain, effective disinfection cannot be achieved. When immersing this product in disinfectant solution, immerse the entire unit. If not properly immersed, effective chemical disinfection cannot be achieved. When this product is immersed in the chemical solution, remove air bubbles on the surface. Not doing so may pose an infection risk. Proceed with gas sterilization after vaporizing water out of this product. If gas sterilization is performed while moisture remains in this product, sterilization of wet parts will be incomplete. 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. When performing ethylene oxide gas sterilization of this product, detach the connector cap from the probe connector. If sterilization is performed while the connector cap is placed on the probe connector, sterilization will be incomplete and may pose an infection risk.

1.3.2 Preventing Electrical Shock

WARNING Connect the power plug to the protective earth receptacle. Not doing so may cause an electric shock. This product is not intended to be used with an electrosurgical unit. If used with an electrosurgical unit, it may cause burn injury to the patient or end-user.

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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. Doing so may cause thermal injury to a patient and/or end-user. Do not hold or scratch this product with metallic forceps, needle, basket, etc. Doing so may damage the ultrasound head and result in damage to tissues inside the body cavities or leakage of the ultrasound transmission medium to the body cavities. Do not insert this product into an endoscope when a clear endoscopic image is not obtained on the monitor or when an endoscopic image is frozen. Doing so may cause damage to tissues in the body cavities, bleeding, perforation or damage to the equipment. When using this product under fluoroscopy, note that a contrast image of the region within approx. 5 mm from the distal end of the endoscopic ultrasonic probe is not obtained. If this product is inserted forcibly, it may cause bleeding or perforation. Slowly insert this product into the endoscope. Inserting it quickly may cause damage to tissues in the body cavity, bleeding or perforation. This product must be properly aerated after ethylene oxide gas sterilization to remove toxic components. Gas remaining in this product after ethylene oxide gas sterilization may harm human body.

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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. After cleaning, rinse off any remaining detergent solution with clean water. If detergent solution remains, it may flow into the patient's body. 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 in chemical solution, rinse off the remaining disinfectant solution with sterile water. If disinfectant solution remains, it may flow into the patient’s body. Proceed with aeration after gas sterilization. If this product is used without performing aeration, gas remaining in this product after gas sterilization may harm human body.

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Chapter 1 Precautions

1.4 Electromagnetic Compatibility (EMC) To avoid electromagnetic interference in the operational environment, read the following precautions and properly handle this product and other devices in the vicinity.

1.4.1 Electromagnetic Compatibility (EMC) R ‌ elated Standard This product has been tested and confirmed to comply with the limits for medical devices defined in EN 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful electromagnetic interference in a typical installation at medical facilities. However, there is a possibility that this product may cause harmful electromagnetic interference to other devices in the vicinity, even if it is used according to the instructions. Also, there is no guarantee that interference will not occur in a particular installation. If this product does cause harmful electromagnetic interference to other devices, that can be determined by turning the equipment off and on, we recommend that you may try to correct the interference by one or more of the following measures: • Change the orientation or position of any affected device. • Increase the spacing between devices. • 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. Otherwise, malfunction of this product may occur.

CAUTION Noise may appear on the monitor of this product due to the effect of electromagnetic waves. In this case, turn off the device emitting the electromagnetic waves or move the device away from this product. Use the cable specified in the Installation Manual of the processor for this product. Use of other cables may cause an increase in electromagnetic emission or decrease in electromagnetic immunity of this product.

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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

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Chapter 1 Precautions

1.5.2 Symbols Symbol

Description Serial number Date of manufacture Manufacturer Authorised representative in the European Community

(Blue)

Refer to instructions for use Temperature limitation Keep dry CE marking Degree of waterproof Type BF applied part

WEEE marking [Note]

Humidity limitation Atmospheric pressure limitation 1

Quantity Application site: Trachea and bronchus Application site: Upper and lower digestive tract

(Yellow)

Ultrasonic frequency: 20 MHz

[Note] This product shall not be treated as household waste.

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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.

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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. This product is a precision instrument. Unnatural force or impact on the insertion portion, ultrasound head or connector. If you encounter any resistance, insert it slowly. Do not insert this product into the endoscope or bend the endoscope without securing a clear endoscopic view on the monitor. Not doing so may cause damage to both this product and body cavities of the patient.

1.7.1 Abnormalities During Use of This Product

WARNING If any abnormality is noticed during use, carry out safety checks and discontinue use immediately.

1.7.2 Transportation and Storage

WARNING Do not store this product in a packaging box. Doing so may cause infection.

CAUTION Store this product under the storage conditions described in “Main Specification.” Use this product in the operating environment described in “Main Specification.”

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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. If the inspection result shows any abnormality, do not use the same equipment. Never use this product for any purposes other than intended use. It may cause severe harm to patient and/or end-users. Do not use this product outside the specified operating environment. Otherwise, it can cause malfunction or equipment failure.

CAUTION In order to successfully sterilize this product by ethylene oxide gas sterilization, use the parameters described in “Table 7.2 Conditions of 20% ethylene oxide gas sterilization (chamber type).” Exceeding the recommended conditions may cause equipment damage.

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