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Olympus BF-1TH190 Скачать руководство пользователя страница 8

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Important Information — Please Read Before Use

BF-190 Series OPERATION MANUAL



Intended use

This instrument is intended to be used with an Olympus video system center, light source,
documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other
ancillary equipment for endoscopy and endoscopic surgery.

This instrument is indicated for use within the airways and tracheobronchial tree.

Do not use this instrument for any purpose other than its intended use.

Select the endoscope to be used according to the objective of the intended procedure based on the full
understanding of the endoscope’s specifications and functionality as described in this instruction
manual.



Applicability of endoscopy and endoscopic treatment

If there are official standards on the applicability of endoscopy and endoscopic treatment that are
defined by the hospital’s administrations or other official institutions, such as academic societies on
endoscopy, follow those standards. Before starting endoscopy and endoscopic treatment, thoroughly
evaluate its properties, purposes, effects, and possible risks (their nature, extent, and probability).
Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its
risks.

Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment
as well as any examination/treatment methods that can be performed in its place, and perform the
endoscopy and endoscopic treatment only after obtaining the consent of the patient.

Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential
benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the
risks to the patient become greater than the potential benefits.

Important Information — Please Read Before Use

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Содержание BF-1TH190

Страница 1: ...Contents 13 Chapter 2 Instrument Nomenclature and Specifications 17 Chapter 3 Preparation and Inspection 27 Chapter 4 Operation 51 Chapter 5 Troubleshooting 75 Appendix 83 Refer to the endoscope s com...

Страница 2: ......

Страница 3: ...Australasia Middle East and Africa 14 Packaged items for countries other than the Americas Europe Australasia Middle East and Africa 15 Chapter 2 Instrument Nomenclature and Specifications 17 2 1 Nome...

Страница 4: ...tion of the suction function 48 Inspection of the instrument channel 49 Chapter 4 Operation 51 4 1 Warnings and cautions operation 51 4 2 Insertion 53 Holding and manipulating the endoscope 53 Inserti...

Страница 5: ...irregularity 79 Withdrawal when the WLI and NBI endoscopic images appear on the monitor 79 Withdrawal when either the WLI or the NBI endoscopic image does not appear on the monitor 80 Withdrawal when...

Страница 6: ...iv Contents BF 190 Series OPERATION MANUAL...

Страница 7: ...nly For a Symbols Glossary visit us http www olympus global com en common pdf symbolsglossary pdf Symbols Symbol Description Refer to instructions Caution Endoscope TYPE BF applied part Single use onl...

Страница 8: ...endoscopic treatment that are defined by the hospital s administrations or other official institutions such as academic societies on endoscopy follow those standards Before starting endoscopy and end...

Страница 9: ...tion using narrowband light Normal light observation or WLI White Light Imaging observation This is observation using white light Image sensor The image sensor is a device that converts light into ele...

Страница 10: ...n REPROCESSING MANUAL with your endoscope model listed on the cover After using this instrument reprocess and store it according to the instructions given in the endoscope s companion reprocessing man...

Страница 11: ...persons other than Olympus own authorized service personnel is excluded from Olympus limited warranty and is not warranted by Olympus in any manner Signal words The following signal words are used thr...

Страница 12: ...d and could cause patient injury burns bleeding and or perforations It could also cause parts of the endoscope to fall off inside the patient Never perform angulation control forcibly or abruptly Neve...

Страница 13: ...ion manual for the light source and the video system center for further details Always maintain a suitable distance necessary for adequate viewing while using the minimum level of illumination for the...

Страница 14: ...making it more difficult to withdraw the endoscope In this case do not use force to withdraw the endoscope because patient injury bleeding and or perforation may result Transnasal insertion is accomp...

Страница 15: ...foration can result CAUTION Do not pull the universal cord during an examination The endoscope connector will be pulled out from the output socket of the light source and the endoscopic image will dis...

Страница 16: ...ion When using an endotracheal tube with the endoscope select the tube that gives a sufficient gap between the insertion section of the endoscope and itself A narrow gap may make it difficult for a pa...

Страница 17: ...t bend hit pull or twist the insertion section bending section control section universal cord and endoscope connector The endoscope may be damaged and water leakage and or breakage of internal parts l...

Страница 18: ...etroflexed Pretreatment to control patient s coughing reflex and other possible unexpected moves is the responsibility of trained specialists Retroflexed observation should be performed only when the...

Страница 19: ...nts Match all items in the package with the components shown below Inspect each item for damage If the endoscope is damaged a component is missing or you have any questions do not use the items immedi...

Страница 20: ...rica Accessories BF XP190 Single use single ended cleaning brush BW 400B 3 pcs Single use combination cleaning brush BW 411B 3 pcs Mouthpiece MA 651 2 pcs Sterilization cap MAJ 1538 Suction cleaning a...

Страница 21: ...XP190 Single use single ended cleaning brush BW 400B 3 pcs BF XP190 Suction connector cleaning brush BW 15SH Except BF XP190 Channel cleaning brush BW 15B Channel opening cleaning brush MH 507 Mouthp...

Страница 22: ...16 1 1 Checking the package contents BF 190 Series OPERATION MANUAL Ch 1...

Страница 23: ...functions 17 BF 190 Series OPERATION MANUAL Ch 2 Chapter 2 Instrument Nomenclature and Specifications The instrument nomenclature functions and specifications are described in this chapter 2 1 Nomenc...

Страница 24: ...18 2 1 Nomenclature and functions BF 190 Series OPERATION MANUAL Ch 2 Control section insertion section 13 13 12 11 9 10 3 1 Top view Insertion tube rotation ring 8 2 4 5 6 7 14...

Страница 25: ...a the biopsy valve 6 Instrument channel port Attach the biopsy valve to this port 7 Color code This color code and numeral show the compatibility of EndoTherapy accessories Blue BF Q190 BF H190 BF P19...

Страница 26: ...on tube to its neutral position turn the insertion tube until the indication aligns with the indication on the control section 16 Insertion tube rotation ring When the ring is turned in the right or l...

Страница 27: ...cope is transported outside the hospital shipment return for repairs etc 22 Universal cord Connects the endoscope connector and the control section 23 Product model and serial number The product name...

Страница 28: ...gf cm2 10 2 15 4 psia Standard storage environment e g within the hospital Ambient temperature 5 40 C 41 104 F Relative humidity 10 95 Atmospheric pressure 700 1060 hPa 0 7 1 1 kgf cm2 10 2 15 4 psia...

Страница 29: ...t channel Channel inner diameter 1 2 mm 2 0 mm Minimum visible distance 1 1 Distance from the distal end of the endoscope 1 5 mm 3 mm Direction from which EndoTherapy accessories enter and exit the en...

Страница 30: ...ter 2 0 mm 2 0 mm 2 8 mm Minimum visible distance 1 1 Distance from the distal end of the endoscope 3 mm 3 mm 3 mm Direction from which EndoTherapy accessories enter and exit the endoscopic image Bend...

Страница 31: ...nt edition 2 IEC 60601 1 2 2001 and edition 3 IEC 60601 1 2 2007 However when connecting to an instrument that complies with the EMC standard for medical electrical equipment edition 1 IEC 60601 1 2 1...

Страница 32: ...26 2 2 Specifications BF 190 Series OPERATION MANUAL Ch 2...

Страница 33: ...ls Should any irregularity be observed after inspection follow the instructions as described in Chapter 5 Troubleshooting If the endoscope malfunctions do not use it Return it to Olympus for repair as...

Страница 34: ...page 29 2 Inspect the endoscope Section 3 3 on page 30 3 Inspect the accessories Section 3 4 on page 36 4 Attach the accessories to the endoscope Section 3 5 on page 40 5 Inspect the ancillary equipme...

Страница 35: ...o the respective instruction manuals for each piece of equipment before use 3 2 Preparation of the equipment Endoscope Endoscope 1 Accessories and ancillary equipment EndoTherapy accessories Suction p...

Страница 36: ...to a difference between internal and external pressures of the endoscope Inspection of the endoscope Figure 3 2 Other Lint free cloths Sterile water Containers for sterile water Figure 3 1 1 Prepare...

Страница 37: ...arities 4 Holding the control section with one hand carefully run your other hand back and forth over the entire length of the insertion section Confirm that no objects or metallic wire protrude from...

Страница 38: ...h thread The adhesives cover them so that they are fixed Therefore the thread is exposed if the adhesives become chipped 9 Wipe the light guide edges of the endoscope connector using clean lint free c...

Страница 39: ...t may be impossible to straighten the bending section during an examination and patient injury bleeding and or perforation may result When rotating the insertion section the bending section bends to a...

Страница 40: ...tion control lever slowly in each direction until it stops Confirm that the bending section angulates smoothly and correctly that maximum angulation can be achieved Figure 3 10 3 Operate the UP DOWN a...

Страница 41: ...y be damaged Once the insertion tube and the insertion tube rotation ring hits against the stopper do not apply excessive additional force The insertion tube and the ring may be damaged When rotating...

Страница 42: ...r more than six procedures The single use suction valve MAJ 209 is disposable Do not attempt to reuse or resterilize it The suction valve is provided in a sterile condition Do not open the package unt...

Страница 43: ...cribed below before each use Replace it with a new one if any irregularity is observed during the inspection An irregular abnormal or damaged valve can reduce the efficacy of the endoscope s suction s...

Страница 44: ...biopsy valve after the expiration date displayed on the sterile package Doing so may pose an infection control risk Do not attempt to sterilize the single use biopsy valve This could pose an infectio...

Страница 45: ...ay cause patient injury and or equipment damage NOTE Placing the mouthpiece in the patient s mouth before the procedure prevents the patient from biting and or damaging the endoscope s insertion secti...

Страница 46: ...gap CAUTION The suction valve does not require lubrication Lubricants can cause swelling of the valve s seals and the valve function may be impaired Figure 3 16 3 5 Attaching accessories to the endos...

Страница 47: ...ray from the endoscope NOTE At low temperature the biopsy valve may become stiff and difficult to attach 3 Inspect and verify that the base of the valve is in contact with the suction cylinder properl...

Страница 48: ...e tube The patient operator and or equipment could be contaminated and equipment malfunction can result CAUTION Before connecting the endoscope connector to the light source confirm that the endoscope...

Страница 49: ...e and or reduce suction capability 1 If any ancillary equipment is ON turn it OFF 2 Hold the endoscope connector while the UP mark is facing upward 3 Insert the endoscope connector completely into the...

Страница 50: ...NOTE If the object cannot be seen clearly wipe the objective lens using clean lint free cloths moistened with 70 ethyl or 70 isopropyl alcohol 3 8 Inspection of the endoscopic system Turn ON the video...

Страница 51: ...the WLI and NBI endoscopic images are free from noise blur fog or other irregularities 5 Operate the UP DOWN angulation control lever slowly in each direction until it stops Figure 3 22 6 Turn the in...

Страница 52: ...during examination and may cause patient injury bleeding and or perforation CAUTION Detach the sterilization cap from the venting connector after gas sterilization e g ethylene oxide gas sterilizatio...

Страница 53: ...rom the biopsy valve Do not depress the suction valve during water feeding If the suction valve is depressed during water feeding water will be aspirated into the suction tube instead of being dischar...

Страница 54: ...ttached or replaced suction valve fails to operate smoothly the endoscope may be malfunctioning stop using it and contact Olympus 1 Turn ON the suction pump 2 Adjust the suction pressure within the ra...

Страница 55: ...apy accessory is closed or retracted into its sheath and slowly insert the EndoTherapy accessory into the forceps port of the forceps irrigation plug Do not open the tip of the EndoTherapy accessory o...

Страница 56: ...50 3 8 Inspection of the endoscopic system BF 190 Series OPERATION MANUAL Ch 3...

Страница 57: ...vel of illumination for the minimum amount of time Do not use close stationary viewing or leave the distal end of the endoscope close to the mucous membrane for a long time without necessity Whenever...

Страница 58: ...ty If any irregularity is observed with the functionality of the endoscope If the endoscopic image on the monitor disappears or freezes unexpectedly If the endoscopic image on the monitor appears blur...

Страница 59: ...caused by the evaporation of organic material blood etc due to heat generated by the light guide near the light guide lens If this vapor continues to interfere with the examination remove the endoscop...

Страница 60: ...s felt or the patient reports pain stop the insertion immediately Otherwise patient injury can result or the endoscope could become lodged and difficult to withdraw CAUTION When inserting the endoscop...

Страница 61: ...nsertion section Figure 4 3 2 If necessary insert the flexible endotracheal tube into the trachea to lead the endoscope smoothly 3 Place the mouthpiece between the patient s teeth or gums with the out...

Страница 62: ...ing section bends to a different direction against the control section Before operating the angulation control lever make sure to check the position of the projection of the insertion tube rotation ri...

Страница 63: ...ion control lever is locked Patient injury bleeding and or perforation may result CAUTION Do not apply excessive force to the insertion tube rotation ring The equipment may be damaged Once the inserti...

Страница 64: ...MANUAL Ch 4 Feeding fluids CAUTION Do not depress the suction valve while feeding fluids The fluids will be aspirated into the suction pump 1 Securely insert a syringe into the slit of the biopsy val...

Страница 65: ...ry to perform the procedure Excessive suction pressure could cause aspiration of and or injury to the mucous membrane In addition patient fluids could leak or spray from the biopsy valve posing an inf...

Страница 66: ...on or withdrawal of EndoTherapy accessories is difficult straighten the bending section as much as possible without losing the endoscopic image Inserting or withdrawing EndoTherapy accessories with ex...

Страница 67: ...or abruptly The EndoTherapy accessory may extend from the distal end of the endoscope abruptly which could cause patient injury bleeding and or perforation For MD 495 When the biopsy valve s cap is de...

Страница 68: ...ory close to the slit of the biopsy valve and insert it straight into the slit using slow short strokes Otherwise the EndoTherapy accessory could bend or break Do not open the tip of the EndoTherapy a...

Страница 69: ...doscope the accessory will appear in the endoscopic image 4 Insert the EndoTherapy accessory slowly and straight into the slit of the biopsy valve Figure 4 6 5 Hold the EndoTherapy accessory at a poin...

Страница 70: ...accessory slowly and straight out of the biopsy valve Otherwise the biopsy valve could be damaged This can reduce the efficacy of the endoscope s suction system and may leak or spray patient debris p...

Страница 71: ...s at an appropriate distance from the distal end of the endoscope Confirm that the entire green marking in case of WLI observation mode at the distal tip of the electrosurgical accessory can be observ...

Страница 72: ...high the endoscope s and or accessory s insulation may be damaged and cause operator and or patient burns NOTE Some Olympus endoscopes are equipped with a feedback circuit to lead leakage current fro...

Страница 73: ...you cannot observe Do not perform APC without gloves Operator injury can result Always confirm that the tissue is an appropriate distance away from the distal end of the endoscope If APC is performed...

Страница 74: ...damaged and cause patient and or operator burns NOTE The outer surfaces of the BF 190 series endoscopes except the BF XP190 are insulated This allows APC to be performed Some Olympus endoscopes are eq...

Страница 75: ...rming laser cauterization Otherwise operator injury may occur CAUTION Before inserting or withdrawing the laser probe return the UP DOWN angulation control lever to its neutral position so that the be...

Страница 76: ...n patient injury and or damage the ultrasonic probe When using the ultrasonic probe with balloon sheath always lubricate the balloon with a medical grade water soluble lubricant before inserting the b...

Страница 77: ...mercially available BAL kit Connect the BAL kit s suction line to the suction connector of the suction valve Figure 4 10 2 Securely insert a syringe filled with lavage fluid e g saline into the slit o...

Страница 78: ...cannot be withdrawn from the patient consider removing it through open surgery and take proper measures Forcibly withdrawing the endoscope or EndoTherapy accessory may cause patient injury bleeding an...

Страница 79: ...may cause equipment damage The carrying case cannot be reprocessed Reprocess the endoscope before placing it in the carrying case Attach the sterilization cap MAJ 1538 when transporting the endoscope...

Страница 80: ...74 4 5 Transportation of the endoscope BF 190 Series OPERATION MANUAL Ch 4...

Страница 81: ...erved while using the endoscope stop using it immediately and withdraw the endoscope from the patient as described Section 5 3 Withdrawal of the endoscope with an irregularity WARNING Never use the en...

Страница 82: ...sidue finger grease dust and lint are on the electrical contacts on the endoscope connector Wipe the electrical contacts on the endoscope connector using clean lint free cloths moistened with 70 ethyl...

Страница 83: ...ttached incorrectly Attach it correctly Close the valve s cap for MD 495 The syringe is not inserted securely Insert it securely The biopsy valve cannot be attached An incorrect biopsy valve is used U...

Страница 84: ...y Straighten it as much as possible Irregularity description Possible cause Solution The remote switch does not work The wrong remote switch is operated Operate the correct remote switch The remote sw...

Страница 85: ...hrough open surgery and take proper measures Forcibly withdrawing the endoscope or EndoTherapy accessory may cause patient injury bleeding and or perforation If any irregularity with the endoscope is...

Страница 86: ...rom the patient s mouth 1 Turn all equipment OFF except the video system center light source and monitor 2 Turn the video system center and light source OFF and then ON again If the WLI or NBI endosco...

Страница 87: ...for any injury or damage that occurs as a result of repairs attempted by non Olympus personnel Before returning the endoscope for repair contact Olympus With the endoscope include a description of the...

Страница 88: ...82 5 4 Returning the endoscope for repair BF 190 Series OPERATION MANUAL Ch 5...

Страница 89: ...ndoscope are listed below Some items may not be available in some areas New products released after the introduction of the endoscope may also be compatible for use in combination with the endoscope F...

Страница 90: ...CV 190 EVIS EXERA III xenon light source CLV 190 Endoscopic ultrasound center 1 EU M30S EU M60 EU MA EU ME1 EU M2000 2 Argon plasma coagulation unit 1 UES 30 2 UES 40 2 PSD 30 PSD 60 ESG 100 ENDOPLAS...

Страница 91: ...ush BW 411B or a set of channel cleaning brush BW 15B and channel opening cleaning brush MH 507 Channel opening cleaning brush MH 507 1 Single use combination cleaning brush BW 411B 1 Leakage tester M...

Страница 92: ...sories Biopsy forceps Alligator jaws type Rat tooth type Endoscope BF XP190 FB 56D 1 BF P190 BF Q190 BF H190 FB 15C 1 FB 56D 1 BF 1TH190 FB 15C 1 Biopsy forceps fenestrated Standard type Standard type...

Страница 93: ...BF Q190 BF H190 FB 52C 1 FB 19CR 1 BF 1TH190 FB 52C 1 FB 19CR 1 FB 22CR 1 FB 55CR 1 Single use biopsy forceps with swing jaws fenestrated Alligator jaws type Alligator jaws type with needle Standard...

Страница 94: ...ingle use grasping forceps Spiral basket type Spiral basket type Three nail type Parallel basket type Endoscope BF XP190 FG 51D FG 52D FG 54D FG 55D BF P190 BF Q190 BF H190 FG 51D FG 52D FG 54D FG 55D...

Страница 95: ...1210 BC 202D 2010 BC 202D 3010 BC 202D 5010 NA 1C 1 NA 2C 1 BF 1TH190 BC 202D 1210 BC 202D 2010 BC 202D 3010 BC 202D 5010 NA 1C 1 NA 2C 1 Single use aspiration needle Single use aspiration needle No...

Страница 96: ...Electrosurgical knife Hot biopsy forceps Crescent Flat type Endoscope BF XP190 BF P190 BF Q190 BF H190 SD 7C 1 SD 18C 1 CD 6C 1 KD 31C 1 FD 7C 1 BF 1TH190 SD 7C 1 SD 18C 1 CD 6C 1 KD 31C 1 FD 6C 1 APC...

Страница 97: ...0 Series OPERATION MANUAL Guide sheath kit Endoscope Single use guide sheath kit BF XP190 BF P190 BF Q190 BF H190 K 201 K 202 BF 1TH190 K 203 K 204 Guiding device Endoscope BF XP190 BF P190 BF Q190 BF...

Страница 98: ...Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Radiated emissions CISPR 11 Class B This instrument s RF emissions are very low and...

Страница 99: ...commercial original condition feeding the facilities or hospital environment Surge IEC 61000 4 5 Differential mode 0 5 1 kV Common mode 0 5 1 2 kV Same as left Mains power quality should be that of a...

Страница 100: ...s may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Electromagnetic interference may occur in the vicinity of high...

Страница 101: ...ast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the m...

Страница 102: ...distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and peopl...

Страница 103: ...reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP OLYMPUS is a registered trademark of OLYMPUS CORPORATION Trademarks product names logos or trade names...

Страница 104: ...Valley Road 12 01 04 Valley Point Office Tower Singapore 248373 Fax 6834 2438 Telephone 6834 0010 A8F Ping An International Financial Center No 1 3 Xinyuan South Road Chaoyang District Beijing 100027...

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