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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

PB2020-M (1)

Operation Manual (1)

202B1263042

21

Chapter 2 Product Overview

PB2020-M_E2-10_202B1263042.indb 21

2016/03/16 16:43:37

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Summary of Contents for PB2020-M

Page 1: ...RATION 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 English PB2020 M_E...

Page 2: ...202B1263042 2 PB2020 M_E2 10_202B1263042 indb 2 2016 03 16 16 43 36...

Page 3: ...e 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 produ...

Page 4: ...r malfunctions and damages resulting from negligence of the precautions and operating methods contained in this manual 7 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting...

Page 5: ...ath 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 1 2 3 Indicates cons...

Page 6: ...pter 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 Thi...

Page 7: ...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 Ul...

Page 8: ...nfection 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 G...

Page 9: ...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 re...

Page 10: ...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...

Page 11: ...infected 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...

Page 12: ...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 a...

Page 13: ...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 pe...

Page 14: ...ns 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 st...

Page 15: ...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 de...

Page 16: ...tion 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 16 Chapter 1 Precautions PB2020 M_E2 10_202B...

Page 17: ...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 lowe...

Page 18: ...ING 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 18 Chapter 1 Prec...

Page 19: ...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 Dur...

Page 20: ...me 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 Ot...

Page 21: ...his products consists of the following components Figures in parentheses indicate the number of articles Endoscopic Ultrasonic Probe PB2020 M 1 Operation Manual 1 202B1263042 21 Chapter 2 Product Over...

Page 22: ...el label Displays the model name 4 Boot Connects the probe connector and the insertion portion 5 Insertion portion applied part Inserted into the body cavity through the endoscope 6 Ultrasound head Co...

Page 23: ...nt may lead to misdiagnosis or increase risks to patient safety CAUTION A liquid ultrasound transmission medium is sealed in this product Depending on the storage conditions air bubbles may appear ins...

Page 24: ...tarches and dents as well as sharp edges and protrusions that may injure the patient 2 Make sure that there are no air bubbles in the ultrasound head Note Remove air bubbles if they are in the ultraso...

Page 25: ...ir bubbles are present Perform steps 3 and 4 to remove air bubbles If the medium is not present Perform steps 2 to 4 to move the medium and to remove air bubbles 2 Leave the ultrasound head downward W...

Page 26: ...4 Once air bubbles are removed keep the endoscopic ultrasonic probe s distal end downward 202B1263042 26 Chapter 3 Inspection Before Use PB2020 M_E2 10_202B1263042 indb 26 2016 03 16 16 43 37...

Page 27: ...ipment failure 2 Insert the insertion portion of this product through the end holder so as to keep the ultrasound head and insertion portion from touching the floor Note In clinical procedures in whic...

Page 28: ...d other components function normally and do not produce abnormal sound 5 Make sure that the image on the monitor shakes when shaking the endoscopic ultrasonic probe s distal end in sterile water 6 Pre...

Page 29: ...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 instrument chan...

Page 30: ...damage the insertion portion of this product If this product is inserted into the forceps valve with a lid open the lid before insertion Not doing so may damage the insertion portion of this product I...

Page 31: ...sound examination with this product it is necessary to have the ultrasound head directly contact the region of interest or have an ultrasound transmission medium such as sterile water between the ultr...

Page 32: ...ight of the monitor and the transducer starts rotating The radial image will be displayed on the monitor 7 In radial scanning ultrasound beam is radiated with the endoscopic ultrasonic probe as its ce...

Page 33: ...re withdrawing this product Withdrawing this product with the forceps stand raised may cause damage to it If it is difficult to remove this product from an endoscope slowly withdraw it while monitorin...

Page 34: ...ep the ultrasound head and insertion portion from touching the floor When inserting the endoscopic ultrasonic probe into an endoscope again pull out the insertion portion from the end holder Note In c...

Page 35: ...aning rinse off any remaining detergent solution with clean water If detergent solution remains it might flow into the patient s body After cleaning rinse off any remaining detergent solution with cle...

Page 36: ...ing enzymatic detergent Follow the instructions provided by the detergent manufacturer regarding how to use and the expiration date For the names of specific brands of detergent solution that have bee...

Page 37: ...tainer for detergent solution disinfectant solution Personal protective equipment Rubber gloves Goggle Facemask Protective clothing Detergent solution disinfectant solution Container for detergent sol...

Page 38: ...ion 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 202B12...

Page 39: ...th detergent solution at the temperature and concentration recommended by the detergent solution s manufacturer 3 Fully immerse the endoscopic ultrasonic probe in detergent solution Note Perform all c...

Page 40: ...ordance with temperature concentration and time recommended by the detergent solution s manufacturer 7 Remove the endoscopic ultrasonic probe from detergent solution 8 Wipe any detergent solution rema...

Page 41: ...lution with clean water If detergent solution remains it may flow into the patient s body Note Perform all rinsing steps while the endoscopic ultrasonic probe is fully immersed in clean water 1 With f...

Page 42: ...face of the endoscopic ultrasonic probe with clean lint free gauze 6 Detach the connector cap from the probe connector 7 Wipe the end of the probe connector with clean lint free gauze 8 Visually inspe...

Page 43: ...isinfectant solution with sterile water Otherwise disinfecting liquid might flow into a patient s body CAUTION Do not use boiling or autoclaving for this product Doing so may cause damage to the endos...

Page 44: ...er 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...

Page 45: ...robe is fully immersed in disinfectant solution 4 Wipe the external surface insertion portion boot probe connector end holder and connector cap of the endoscopic ultrasonic probe with sterile gauze in...

Page 46: ...erature concentration and time recommended by the disinfectant solution s manufacturer Cover the basin with a lid during disinfection 8 Remove the endoscopic ultrasonic probe from disinfectant solutio...

Page 47: ...nnector end holder and connector cap of the endoscopic ultrasonic probe with sterile gauze in sterile water to remove air bubbles completely 4 Rinse the endoscopic ultrasonic probe by gently shaking i...

Page 48: ...he 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 4 Ensure that the endoscopic ultrasonic p...

Page 49: ...this product sterilization of wet parts will be incomplete CAUTION Proceed with aeration after gas sterilization If this product is used without performing aeration gas remaining in this product after...

Page 50: ...is 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 CAUTION I...

Page 51: ...nd then seal the pack tightly Place it in an EOG sterilizer 3 Sterilize this product according to the operating procedure of the EOG sterilizer 4 Sterilize this product for a specified time and aerate...

Page 52: ...nfected in a location that meets the following conditions Temperature 20 to 60 C Humidity 10 to 85 RH no dew condensation Pressure 70 to 106 kPa within range of atmospheric pressure State of the endos...

Page 53: ...se in combination with the SP 900 ultrasonic processor Applied Part Insertion portion Specifications Working length 2150 mm Outside diameter of insertion portion 1 4 mm to 1 9 mm Maximum diameter of i...

Page 54: ...w condensation 70 to 106 kPa within range of atmospheric pressure Storage Environment Temperature Humidity Pressure 20 to 60 C 10 to 85 RH no dew condensation 70 to 106 kPa within range of atmospheric...

Page 55: ...y energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electric equipment Radiated emissions EN 55011 Class B This produ...

Page 56: ...hould be that of a typical commercial or hospital Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 11 5V 218 5V dip For 0 5 cycle 92V 138V dip For 5 cy...

Page 57: ...uirements of EN 60601 1 2 2007 However electromagnetic interference may occur on this product under electromagnetic environment that exceeds its noise level Electromagnetic interference may occur in t...

Page 58: ...ipment By ensuring this product is disposed of correctly you will help prevent potential negative consequences to the environment and human health which could otherwise be caused by inappropriate wast...

Page 59: ...ons used in this manual 5 E End holder 22 I Insertion portion 22 Inspection 23 L Label 22 M Maintenance 4 P Precautions 9 Probe code 22 Probe connector 22 S Safety 10 Specifications 53 Storage 54 U Ul...

Page 60: ...try 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 FUJIFILM Singapore Pte Ltd http w...

Page 61: ...202B1263042 61 Service Centers PB2020 M_E2 10_202B1263042 indb 61 2016 03 16 16 43 40...

Page 62: ...1 0 DT E2 Printed in Japan FUJIFILM Europe GmbH Heesenstrasse 31 40549 Duesseldorf Germany FUJIFILM Corporation 26 30 Nishiazabu 2 chome Minato ku Tokyo 106 8620 Japan PB2020 M_E2 10_202B1263042 indb...

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