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FU49A

202B1263042

160316-1.0-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 62

2016/03/16 16:43:41

Содержание PB2020-M

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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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