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Appendix D: Acoustic Output Information Accordance with IEC 60601-2-37

163

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

Appendix D: Acoustic Output
Information Accordance with
IEC 60601-2-37

Acoustic output table with Olympus compact
endoscopic ultrasound center

BF-UC180F will not exceed an MI of 1.0, or an I

spta.3

of 720 mW/cm

in any

mode. In addition, BF-UC180F will not exceed a TI of 1.0 in any mode.

Acoustic output table with Hitachi diagnostic
ultrasound system

The terms used in the acoustic output table are as follows:

Acoustic attenuation coefficient

–12 dB output beam area

Normalizing coefficient

Equivalent aperture diameter

Pulse beam width

Equivalent beam diameter

awƒ

Acoustic working frequency

Pulse-average intensity

Attenuated pulse-average intensity

Pulse-intensity integral

Attenuated pulse-intensity integral

Temporal-average intensity

Attenuated temporal-average intensity



aprt

(z)

–









(z)



( z )

Содержание BF UC180F

Страница 1: ...e use of this document TECH READY document Product OLYMPUS Evis Exera II Ultrasonic Bronchofibervideoscope Model OLYMPUS BF TYPE UC180F Extended Tech Ready The detail required in cleaning maintaining...

Страница 2: ...device to sale by or on the order of a physician CAUTION Balloons Used with This Product Contain Natural Rubber Latex Which May Cause Allergic Reactions INSTRUCTIONS EVIS EXERA II ULTRASONIC BRONCHOF...

Страница 3: ......

Страница 4: ...s of inappropriate handling 10 Chapter 1 Checking the Package Contents 11 1 1 Standard components 11 1 2 Ultrasonic cable 12 1 3 Optional components 13 Chapter 2 Instrument Nomenclature and Specificat...

Страница 5: ...nfectant solution 78 6 5 Rinse water 78 6 6 Ethylene oxide gas sterilization 79 6 7 Steam sterilization autoclaving of accessories 81 Chapter 7 Cleaning Disinfection and Sterilization Procedures 82 7...

Страница 6: ...MC information 150 Appendix C Acoustic Output Information in Accordance with the FDA Guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers...

Страница 7: ...Contents iv ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF UC180F...

Страница 8: ...this instrument are as follows Refer to instructions Caution TYPE BF applied part Serial number IPX7 Ingress protection rating except for connectors Ultrasonic endoscope Single use only Do not resteri...

Страница 9: ...RASONIC BRONCHOFIBERVIDEOSCOPE BF UC180F Contains or Presence of Natural Rubber Latex Lock the ultrasonic connector Release the ultrasonic connector Manufacturer Authorized representative in the Europ...

Страница 10: ...official standard on the applicability of endoscopy and endoscopic treatment that is defined by the hospital s administration or other official institutions such as academic societies on endoscopy fo...

Страница 11: ...must be a physician approved by the medical safety manager of the hospital or person in charge of the department department of internal medicine etc The physician should be capable of safely performin...

Страница 12: ...at the examination will be interrupted due to equipment failure or malfunction Maintenance management The probability of failure of the endoscope and ancillary equipment increases as the number of pro...

Страница 13: ...een the direction of view and the insertion direction of the endoscope The insertion direction appears in the lower portion of the endoscopic view and the visible area in that direction is limited Alw...

Страница 14: ...result in patient injury Transnasal insertion is accompanied by the risk of inflammation of the nasal cavity If this happens the nasal passage will be constricted making it more difficult to withdraw...

Страница 15: ...ng the endoscope may cause tissue damage bleeding or perforation Do not pull the universal cord during an examination The endoscope connector will be pulled out from the output socket of the light sou...

Страница 16: ...mage whenever you are not actively viewing the live ultrasonic image When the equipment is in the FREEZE mode no ultrasonic energy is emitted Electromagnetic interference may occur on this instrument...

Страница 17: ...lumen may make it impossible to straighten the angle of the bending section and or withdraw the endoscope from the patient In case the patient moves due to coughing and other reasons while the endosc...

Страница 18: ...Cleaning Disinfection and Sterilization Procedures Endoscope Cap chain MAJ 1723 Single use suction valve MAJ 209 20 pcs sterile or suction valve MAJ 207 10 pcs Balloon applicator MAJ 1352 Balloon MAJ...

Страница 19: ...e BF UC180F The ultrasonic cable is optional and may be purchased from Olympus For the Olympus compact endoscopic ultrasound center For the diagnostic ultrasound system Hitachi Ltd and the Olympus uni...

Страница 20: ...BRONCHOFIBERVIDEOSCOPE BF UC180F 1 3 Optional components The items listed below are optional and may be purchased from Olympus Biopsy valve For the U S A For countries other than the U S A Single use...

Страница 21: ...DEOSCOPE BF UC180F Chapter 2 Instrument Nomenclature and Specifications 2 1 Nomenclature Universal cord Product number and serial number Electrical contact points 2 Endoscope connector Light guide 1 U...

Страница 22: ...alve MAJ 207 for the countries other than the U S A or single use suction valve MAJ 209 for the U S A Slit 5 Single use adapter biopsy valve MAJ 1414 6 Instrument channel port 7 Irrigation port Insert...

Страница 23: ...J 207 for the countries other than the U S A or single use suction valve MAJ 209 for the U S A This valve is depressed to activate suction The valve is used to remove any fluid and debris that obstruc...

Страница 24: ...e bending section moves DOWN 2 3 Specifications Compared with the BF UC160F OL8 the channel inner diameter of the BF UC180F is increased from 2 0 mm to 2 2 mm However the compatible EndoTherapy access...

Страница 25: ...1 1 kgf cm2 10 2 15 4 psia Model BF UC 180F Optical system Field of view 80 Direction of view 35 Forward oblique Depth of field 2 50 mm insertion section Distal end outer diameter 6 9 mm insertion se...

Страница 26: ...ction Parallel to the insertion direction Transmitting frequency 7 5 MHz Scanning range 50 Contacting method Balloon method Direct contact method Operation mode B mode M mode D mode Bflow mode Pawerfl...

Страница 27: ...isted in the left column CISPR 11 of emission Group 1 Class B This instrument complies with the EMC standard for medical electrical equipment edition 2 IEC 60601 1 2 2001 However when connecting to an...

Страница 28: ...ed in an endoscope reprocessor such as OER 1 OER A 1 with an ultrasonic cleaning phase When attaching the water resistant cap to the electrical connector do not pinch the cap chain between the electri...

Страница 29: ...ation or other damages see Figure 2 1 2 Align the notch on the connecting plate with the pin on the venting connector of the water resistant cap MH 553 see Figure 2 2 3 Place the connecting plate over...

Страница 30: ...menclature and Specifications 23 ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF UC180F Figure 2 3 The instructions on the remaining pages of this manual are given under the assumption that the cap chain is deta...

Страница 31: ...5 If any irregularities are suspected after inspection follow the instructions given in Chapter 10 Troubleshooting This instrument was not cleaned disinfected or sterilized before shipment Before usin...

Страница 32: ...he respective instruction manuals for each piece of equipment Figure 3 1 Paper towels Trays Lint free cloths Personal protective equipment 3 way stopcock Syringe Extension tube Sterile deaerated water...

Страница 33: ...nsformation bends adhesion of foreign body detached parts protruding objects or any other irregularities 4 Holding the insertion section gently with one hand carefully run your fingertips over the ent...

Страница 34: ...ing section does not angulate smoothly the bending mechanism may be abnormal In this case do not use the endoscope because it may become impossible to straighten the bending section during an examinat...

Страница 35: ...played on the sterile package Doing so may pose an infection control risk Do not attempt to reuse or sterilize the single use suction valve MAJ 209 Doing so could pose an infection control risk or cau...

Страница 36: ...he suction valve MAJ 207 for more than six procedures This suction valve MAJ 207 is designed for use with BF 30 40 60 200 240 260 160 and 180 series endoscopes 1 Confirm that the valve is not deformed...

Страница 37: ...ion control risk Do not attempt to reuse or sterilize the single use adapter biopsy valve MAJ 1414 Doing so could pose an infection control risk or cause equipment damage This single use adapter biops...

Страница 38: ...trol risk or cause equipment damage Do not use the single use biopsy valve MAJ 210 with the single use aspiration needle NA 201SX 4022 Please use the single use adapter biopsy valve MAJ 1414 And refer...

Страница 39: ...may cause patient debris to leak or spray from the endoscope posing an infection control risk Do not use the biopsy valve MD 495 with the single use aspiration needle NA 201SX 4022 Please use the sing...

Страница 40: ...cause patient injury and or equipment damage Place the mouthpiece in the patient s mouth before the procedure to prevent the patient from biting and or damaging the endoscope s insertion section 1 Co...

Страница 41: ...tion cylinder the suction valve may be detached from the endoscope and patient debris may leak or spray from the gap posing an infection control risk The suction valve does not require lubrication Lub...

Страница 42: ...cylinder the valve is not properly attached and patient debris or fluid may leak or spray from the gap see Figure 3 11 Figure 3 11 Sometimes the suction valve will click before it is fully seated in t...

Страница 43: ...irmly attached to the instrument channel port of the endoscope At low temperatures the housing may become stiff and difficult to attach Figure 3 12 Attaching the single use biopsy valve MAJ 210 If the...

Страница 44: ...properly connected to the instrument channel port it can reduce the efficacy of the endoscope s suction system and may cause patient debris to leak or spray from the endoscope posing an infection cont...

Страница 45: ...doscope connector videoscope cable and video system center are not connected properly the endoscopic image may flicker or not be displayed Continuous use of such an endoscope may cause patient injury...

Страница 46: ...e 3 15 Figure 3 15 5 Turn the connector of the videoscope cable clockwise until it stops see Figure 3 15 6 Confirm that the mark on the videoscope cable is aligned with mark 2 on the endoscope connect...

Страница 47: ...ultrasonic cable refer to the System chart in the Appendix 1 Make sure that the inside of the ultrasonic connector is dry and free of debris 2 Align the mark on the ultrasonic cable with mark A on the...

Страница 48: ...ontacts with your hands If the electrical contacts are dirty wipe the contacts with a clean soft lint free cloth Do not open the flip cover of the ultrasound center with excessive force Otherwise the...

Страница 49: ...he receptacle on the socket of the compact endoscopic ultrasound center and insert it by pushing the ultrasonic connector into the receptacle of the compact endoscopic ultrasound center The ultrasonic...

Страница 50: ...UC180F 4 Turn the lever counterclockwise until it stops see Figure 3 22 Figure 3 22 5 Press the lever down until it snaps into place securing the ultrasonic connector to the system see Figure 3 23 Fi...

Страница 51: ...he probe connectors on the lower side PROBE 3 or 4 of the ProSound F75 see Figure 3 24 If the Ultrasonic connector is connected to one of the probe connectors on the upper side PROBE 1 or 2 the operat...

Страница 52: ...rn the video system center light source and monitor ON and inspect the endoscopic image as described in their respective instruction manuals 2 Confirm that light is output from the endoscope s distal...

Страница 53: ...smoothly detach it and attach it again or replace it with a new suction valve If it still does not work smoothly the endoscope may be malfunctioning stop using it and contact Olympus If the endoscope...

Страница 54: ...ory can be withdrawn smoothly from the biopsy valve Inspection of the water feeding function 1 Insert a syringe filled with sterile water into the biopsy valve and depress the plunger 2 Confirm that w...

Страница 55: ...ment Therefore it is desirable to use saline solution for avoiding airway irritation 1 Connect the extension tube 3 way stopcock and syringe to the irrigation port as shown in Figure 3 25 2 Fill the s...

Страница 56: ...doscopic ultrasound center 3 Press the US EXT switch and make sure that the initial image is displayed on the monitor see Figure 3 26 Figure 3 26 Inspection of the ultrasonic image with the diagnostic...

Страница 57: ...ly reprocessed as described in Chapters 5 Reprocessing General Policy through 7 Cleaning Disinfection and Sterilization Procedures If you find a peel pack that is open damaged or soiled do not use the...

Страница 58: ...applicator Fold the rear band back onto the applicator see Figure 3 28 Figure 3 28 4 Position the rear band onto the groove of the applicator see Figure 3 29 Figure 3 29 5 Open the applicator wide eno...

Страница 59: ...o or bend the distal end of the endoscope Instrument damage may occur 6 Insert the transducer of the endoscope into the balloon see Figure 3 31 Figure 3 31 7 Put the rear band of the balloon into the...

Страница 60: ...and depress the plunger to inflate the balloon While inflating the balloon point the distal end of the endoscope upward see Figure 3 34 Figure 3 34 In Step 10 the balloon s front band is not attached...

Страница 61: ...on with your fingers and squeeze out air bubbles from the front end of the balloon see Figure 3 35 Figure 3 35 Do not apply excessive force to or bend the distal end of the endoscope Instrument damage...

Страница 62: ...4 If the water leaks from the band of the balloon press the band into the balloon groove 5 If air bubbles are observed in the balloon lower the distal end of the endoscope see Figure 3 37 Deflate the...

Страница 63: ...any of the following conditions Otherwise patient injury bleeding and or perforation can result While the EndoTherapy accessory extends from the distal end of the endoscope While the bending section...

Страница 64: ...end of the endoscope close to the mucous membrane for a long time without necessity Whenever possible do not leave the endoscope illuminated before and or after an examination Continued illumination w...

Страница 65: ...lubricate the balloon before insertion Otherwise the balloon could rupture or come off This could result in patient injury Never force the insertion section if resistance is encountered Patient injury...

Страница 66: ...see Figure 4 1 Figure 4 1 Insertion of the endoscope Do not apply olive oil or products containing petroleum based lubricants e g Vaseline These products may cause stretching and or deterioration of t...

Страница 67: ...rt the distal end of the endoscope through the opening of the mouthpiece then from the mouth to the pharynx while viewing the endoscopic image Angulation of the distal end Avoid forcible or excessive...

Страница 68: ...onnect the suction tube from the suction connector on the suction valve Turn the suction pump OFF When aspirating attach the biopsy valve cap to the main body Failure to do so can reduce the efficacy...

Страница 69: ...the video system center is too high Set the iris mode selection switch on the video system center to peak iris mode However when the image turns dark by using EndoTherapy accessories set the iris mode...

Страница 70: ...rasound system to change the ultrasonic image to REAL TIME mode 2 Turn the 3 way stopcock and inflate the balloon to the desired diameter by pushing the syringe s plunger When inflation is complete tu...

Страница 71: ...be seen in the endoscopic image which could cause serious patient injury and or equipment damage The minimum visible distance depends on the type of endoscope being used Refer to Section 2 3 Specifica...

Страница 72: ...rtion of EndoTherapy accessories into the endoscope Do not insert EndoTherapy accessories forcibly or abruptly Otherwise the EndoTherapy accessory may extend from the distal end of the endoscope abrup...

Страница 73: ...observing the endoscopic image Operation of EndoTherapy accessories Operate the EndoTherapy accessory according to the directions given in its instruction manual Withdrawal of EndoTherapy accessories...

Страница 74: ...nsert the channel cleaning brush BW 7B into the irrigation port to remove debris The balloon will be automatically deflated If the endoscope cannot be withdrawn from the patient smoothly do not attemp...

Страница 75: ...cause the ultrasonic image to be abnormal Do not pinch the ultrasonic transducer surface and balloon together when removing the balloon Doing so could damage the ultrasonic transducer and or cause the...

Страница 76: ...Chapter 4 Operation 69 ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF UC180F Figure 4 5 Figure 4 6...

Страница 77: ...gure 4 7 Figure 4 7 Transporting outside the hospital Transport the endoscope in the carrying case Always clean disinfect or sterilize the endoscope after removing it from the carrying case If the end...

Страница 78: ...if a problem that cannot be solved occurs while reprocessing contact Olympus 5 2 Importance of cleaning disinfection and sterilization The medical literature reports incidents of cross contamination r...

Страница 79: ...ators performing the next procedure with the endoscope If the endoscope is not cleaned meticulously effective disinfection or sterilization may not be possible Clean the endoscope and accessories thor...

Страница 80: ...ir tight container Alcohol stored in an open container is a fire hazard and will lose its efficacy due to evaporation Be sure to perform a leakage test on the endoscope prior to manual cleaning and do...

Страница 81: ...ot guarantee the effectiveness safety and durability of this instrument Make sure to confirm that there is no irregularity before use and use under responsibility of a physician Do not use if any irre...

Страница 82: ...summary Olympus endoscopic equipment is compatible with several methods of reprocessing However certain components and accessories are not compatible with some methods which can cause equipment damag...

Страница 83: ...g brush MH 507 Suction valve MAJ 207 Biopsy valve MD 495 Suction cleaning adapter MAJ 222 Balloon applicator MAJ 1352 Mouthpiece MA 651 Ultrasonic cable MAJ 1722 MAJ 1597 compatible not compatible Tab...

Страница 84: ...of the endoscope and accessories For these purposes use either fresh potable tap water or water that has been processed e g filtered deionized or purified to improve its chemical and or microbiologica...

Страница 85: ...l disinfection are compatible with Olympus endoscopes Contact Olympus for the names of specific brands that have been tested for compatibility with this endoscope If disinfectant solution is reused ro...

Страница 86: ...instrument must be thoroughly cleaned and dried Residual moisture may inhibit sterilization Use biological indicators as recommended by your hospital s policy and follow the manufacturer s instruction...

Страница 87: ...psia Relative humidity 50 80 Ethylene oxide gas concentration 0 735 0 740 mg cm3 735 740 mg L Exposure time 60 minutes Aeration Minimum aeration parameters 12 hours in an aeration chamber at 50 57 C...

Страница 88: ...low the manufacturer s instructions and all national and local hospital guidelines and policies Effective sterilization will not be possible if items are packed tightly together in the autoclave alway...

Страница 89: ...leaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and or operators performing the next procedure with the endoscope Do not coil the endoscope...

Страница 90: ...and disinfectant solution Clean lint free cloth Clean water see Section 6 2 Large basin for rinsing and leakage testing Sterile lint free cloth Sterile water 30 cm3 30 ml syringe Sterile cotton swabs...

Страница 91: ...onnector and the ultrasonic cable connector on the endoscope to protect the connectors from water penetration during reprocessing For leakage testing the venting connector on the water resistant cap m...

Страница 92: ...brush is used to brush the inside of the instrument channel and the suction channel see Figure 7 4 Figure 7 4 Single use channel cleaning brush BW 201B The single use channel cleaning brush is used to...

Страница 93: ...g brush or the single use single ended cleaning brush is used to clean the balloon channel see Figure 7 6 Figure 7 6 Channel opening cleaning brush MH 507 reusable The channel opening cleaning brush i...

Страница 94: ...single use combination cleaning brush is used to brush the inside of the instrument channel suction channel and the interior and or openings of the suction valve AW channel cleaning adapter and biops...

Страница 95: ...the water resistant caps is dry and free from debris see Figure 7 2 on page 84 Wipe with a dry cloth when the inside of the water resistant cap is wet or debris is detected 2 Confirm that the seal in...

Страница 96: ...se Doing so may damage the equipment Using damaged equipment may make it difficult to effectively reprocess the endoscope and could cause endoscope and or equipment damage Do not store the equipment o...

Страница 97: ...r missing bristles 3 Check for bends scratches and other damage to the shaft 4 Check for debris on the shaft and or in the bristles of the brush Figure 7 10 Inspection of the single use channel openin...

Страница 98: ...nd are securely attached 3 Check the channel cleaning brush and the channe opening cleaning brush parts for loose or missing bristles 4 Check the bristles of the channel cleaning brush and the channel...

Страница 99: ...level disinfected or sterilized during EVERY reprocessing cycle even if the channels were not used during the previous patient procedure Otherwise insufficient cleaning and disinfection or sterilizati...

Страница 100: ...Equipment needed Prepare the following equipment and wear appropriate protective equipment Preparation 1 Turn the ultrasound center video system center and light source OFF 2 Prepare detergent soluti...

Страница 101: ...attach the biopsy valve cap 3 Immerse the distal end of the insertion section in detergent solution Press the suction valve and aspirate detergent solution into the channel for 30 seconds see Figure 7...

Страница 102: ...he endoscope reusable parts and cleaning equipment Do not touch the light guide of the endoscope connector immediately after removing it from the light source because it is extremely hot Operator or p...

Страница 103: ...it Figure 7 15 4 When using the single use biopsy valve MAJ 210 remove it as shown in Figure 7 16 below and discard it When using the biopsy valve MD 495 remove it and place it in a container with de...

Страница 104: ...ource 8 Transport the endoscope and the container holding the other items to the reprocessing area 7 4 Leakage testing After precleaning perform leakage testing on the endoscope to ensure that it is w...

Страница 105: ...he ultrasonic connector and or the electrical connector Always use a dry water resistant cap Any water remaining on the water resistant cap may cause damage to the endoscope maintenance unit or light...

Страница 106: ...rforming leakage testing cleaning disinfection or using an endoscope reprocessor b When using a manual disinfector Rotate Mark 2 yellow 2 3 4 2 3 4 Mark 2 yellow Rotate Water resistant cap a When perf...

Страница 107: ...he water resistant cap s venting connector make sure that the inside of the leakage tester s connector cap and the outside of the water resistant cap s venting connector are completely wiped and dry W...

Страница 108: ...and observe for approximately 30 seconds while angulating the bending section Confirm that there is no location on the endoscope from that a continuous series of bubbles emerges 6 Remove the endoscop...

Страница 109: ...ndoscope Equipment needed Prepare the following equipment and wear appropriate personal protective equipment Water resistant cap 2 pcs MH 553 Chain for water resistance caps MAJ 1723 Personal protecti...

Страница 110: ...by 40 cm 16 by 16 in size and deep enough to completely immerse the endoscope 2 Fill a basin with clean water Use a basin that is at least 40 cm by 40 cm 16 by 16 in size and deep enough to completely...

Страница 111: ...dure Depending on the location the missing part may not be recoverable by passing a new brush or other EndoTherapy accessory through the channel In this case contact Olympus When using the single use...

Страница 112: ...groove in the opening leading to impaired suction and liquid leakage Do not attempt to pass the channel cleaning brush BW 15B the single use channel cleaning brush BW 201B the single use combination...

Страница 113: ...n the detergent solution Carefully pull the brush out through the channel 4 Clean the bristles in the detergent solution again 5 Repeat until all debris is removed Brushing the channel through the ins...

Страница 114: ...the suction cylinder as illustrated by C in Figure 7 20 on page 105 until half of the bristles are inserted 2 Turn the inserted brush once 3 Pull the brush out and clean the bristles in the detergent...

Страница 115: ...through the channel 4 Clean the bristles with your fingertips in the detergent solution 5 Repeat until all debris is removed Brushing the irrigation port location F 1 Insert the channel opening cleani...

Страница 116: ...ment channel port Attach the suction cylinder cap to the suction cylinder see Figure 7 21 2 Connect the suction tube from the suction pump to the suction opening of the suction cleaning adapter 3 Turn...

Страница 117: ...he syringe to fill the suction cleaning adapter and the channel with the detergent solution see Figure 7 21 4 Attach the syringe to the irrigation port and withdraw the plunger of the syringe to fill...

Страница 118: ...he endoscope 3 Cover the basin with a tight fitting lid to minimize the release of detergent vapors 4 Soak the endoscope and all reprocessing equipment for the amount of time and at the temperature an...

Страница 119: ...air for 20 seconds 4 Turn the suction pump OFF 5 Disconnect the suction cleaning adapter from the endoscope 6 Disconnect the suction tube from the suction cleaning adapter 7 Attach the syringe to the...

Страница 120: ...n 12 cm Equipment damage can result 3 Connect the suction cleaning adapter to the endoscope Complete immerse the endoscope in the detergent solution 4 Attach a 30 cm3 30 ml syringe to the suction clea...

Страница 121: ...aning disinfect the endoscope according to the procedures described below Equipment needed Prepare the following equipment and wear appropriate personal protective equipment Preparation 1 Fill a basin...

Страница 122: ...leaning adapter completely immersed in the disinfectant solution disconnect all reprocessing equipment from the endoscope Leave the endoscope and all reprocessing equipment immersed in the disinfectan...

Страница 123: ...level disinfection After reprocessing purge the channels of the endoscope to thoroughly dry them Otherwise bacteria may proliferate in the channels and pose an infection control risk to the patient an...

Страница 124: ...n pump ON 5 Aspirate sterile water for 30 seconds 6 Remove the endoscope from the sterile water and aspirate air for 60 seconds 7 Turn the suction pump OFF 8 Immerse the distal end of the insertion se...

Страница 125: ...23 Figure 7 23 12 Disconnect the syringe from the endoscope 13 Wipe and dry the external surfaces of the endoscope and suction cleaning adapter with a sterile lint free cloth 14 Dry the endoscope and...

Страница 126: ...cm3 30 ml of alcohol through the balloon channel Repeat this procedure 5 times 8 Remove the distal end of the endoscope from the alcohol and flush 30 cm3 30 ml of air through the balloon channel 5 ti...

Страница 127: ...s subjected to ethylene oxide gas sterilization If the water resistant caps is connected to the endoscope be sure to remove the water resistant caps from the endoscope before proceeding to ethylene ox...

Страница 128: ...ion procedures for reusable parts and cleaning equipment This section includes the cleaning disinfection and sterilization procedures for the reusable parts and reprocessing equipment listed below For...

Страница 129: ...nt free cloths Sterile lint free cloths Large basins Detergent solution Disinfectant solution Clean water nonsterile water Sterile water for sterile water rinse Small container 70 ethyl or isopropyl a...

Страница 130: ...re that the items immersed in detergent solution do not contact one another 1 Fill a small basin with clean water Use a basin that is deep enough to completely immerse all equipment 2 Fill a small bas...

Страница 131: ...s of all equipment until no air bubbles can be seen 11 Rub the bristles of the channel cleaning brushes BW 15B BW 7B or the single use single ended cleaning brush BW 400B and channel opening cleaning...

Страница 132: ...ution to remove all air bubbles 4 Using the 30 cm3 30 ml syringe flush the interior and recessed parts of them while they are immersed Ensure that all air bubbles are expelled 5 Using the 30 cm3 30 ml...

Страница 133: ...basin that is deep enough to completely immerse all equipment 2 Immerse all equipment in the sterile water 3 Gently agitate all equipment to thoroughly rinse them 4 Using the 30 cm3 30 ml syringe flu...

Страница 134: ...e flush the interior and recessed parts of all equipment with alcohol to remove all air bubbles 7 Rub the bristles of the channel cleaning brushes and channel opening cleaning brush to remove all air...

Страница 135: ...e 93 and Section 7 5 Manual cleaning on page 102 follow the procedures given below Exceeding the recommended parameters may cause equipment damage The cleaning brushes are not compatible with ETO gas...

Страница 136: ...s described below Allow the packages to dry within the autoclave using the autoclave s drying cycle if available or by opening the door of the autoclave and allowing the packages to air dry Handling a...

Страница 137: ...0F Assembling the suction valve MAJ 207 1 Press the valve into the main body see Figure 7 26 2 Attach the spring to the main body see Figure 7 26 3 Insert the piston through the components and press i...

Страница 138: ...stened with neutral detergent 2 To remove dust dirt and other non patient debris wipe the cable s surface with a soft lint free cloth moistened with 70 ethyl or isopropyl alcohol 3 Make sure that the...

Страница 139: ...t debris may solidify which could impair proper cleaning and disinfection of the endoscope Refer to the endoscope reprocessor s instruction manual for details on proper connection of the endoscope to...

Страница 140: ...sted in the instruction manual for the endoscope reprocessor If your endoscope model is not listed in that instruction manual please contact the manufacturer of the endoscope reprocessor If using the...

Страница 141: ...ssor OER A Connect each cleaning tube to the connector without folding or bending the tube If the tube is bent or connected improperly the fluid feed may be insufficient This can reduce the effectiven...

Страница 142: ...recommended by Olympus refer to the instruction manual to set BF UC180F OER A is not available in some areas Set up procedure Set up sequence Control section insertion section Universal cord Endoscop...

Страница 143: ...cord will be kinked and BF UC180F will be damaged when close the cleaning cover of the endoscope reprocessor OER AW Connect each connecting tube to the connector without folding or bending the tube If...

Страница 144: ...recommended by Olympus refer to the instruction manual to set BF UC180F OER AW is not available in some areas Set up procedure Set up sequence Control section insertion section Universal cord Endosco...

Страница 145: ...allow air to circulate through the internal lumens of the endoscope and will assist drying Do not store the endoscope in the carrying case Use the carrying case only for shipping the endoscope Routine...

Страница 146: ...3 Storage of ultrasonic cable The storage cabinet must be clean dry well ventilated and maintained at ambient temperature Storing the ultrasonic cable in direct sunlight at high temperatures in high h...

Страница 147: ...lympus does not repair accessory parts If an accessory part becomes damaged contact Olympus to purchase a replacement Never use the endoscope on a patient if any irregulality is observed Damage or irr...

Страница 148: ...ble cause Solution There is no video image Not all power switches are ON Turn ON all the power switches An image is not clear The objective lens is dirty Clean the objective lens with lint free cloths...

Страница 149: ...lace it with a new one The suction valve is sticky The suction valve is damaged Replace it with a new one The suction valve does not return to its original position The aspiration pressure is too high...

Страница 150: ...his happens multiple echoes have coalesced and disturbed the ultrasonic image Keep the endoscope s distal end away from an object with strong reflection Irregularity description Possible cause Solutio...

Страница 151: ...tempt to forcibly withdraw it deal with it appropriately If any irregularities are observed immediately contact Olympus Forcibly withdrawing the endoscope or EndoTherapy accessory may cause patient in...

Страница 152: ...and or retracted into its sheath 5 Turn the UP DOWN angulation control lever to the neutral position Release the angulation control lever and carefully withdraw the endoscope 6 Remove the mouthpiece f...

Страница 153: ...s instrument are listed below Some items may not be available in some areas New products released after the introduction of this instrument may also be compatible for use in combination with this inst...

Страница 154: ...VIS EXERA II video system center CV 180 EVIS EXERA video system center CV 145 1 CV 160 Balloon MAJ 1351 EVIS EXERA II light source CLV 180 EVIS universal light source CLV U40 Mouthpiece MA 651 Hitachi...

Страница 155: ...tion cleaning adapter MAJ 222 Channel opening cleaning brush MH 507 or single use channel opening cleaning brush MAJ 1339 1 Leakage tester MB 155 Maintenance unit MU 1 Water resistant cap MH 553 Ultra...

Страница 156: ...ps Disposable biopsy forceps fenestrated Disposable Rat tooth Fenestrated Alligator jaws swinging type BF UC180F NA 201SX 4022 FB 56D 1 FB 19C 1 FB 19CR 1 FB 211D Endoscope Disposable biopsy forceps f...

Страница 157: ...nternal function 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...

Страница 158: ...f a typical 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 b...

Страница 159: ...reflection from structures objects and people This instrument complies with the requirements of IEC 60601 1 2 2001 However under electromagnetic environment that exceeds its noise level electromagnet...

Страница 160: ...o broadcast 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...

Страница 161: ...paration 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 a...

Страница 162: ...Systems and Transducers Acoustic output table with Olympus compact endoscopic ultrasound center The terms used in the acoustic output table are as follows ISPTA 3 is the derated spatial peak temporal...

Страница 163: ...uncertainty All table entries have been obtained at the same operating conditions that give rise to the maximum index value in the first column of the table Measurement precision and uncertainty for...

Страница 164: ...intensity at axial distance z1 z1 Axial distance corresponding to the location of max min W0 3 z1 Ita0 3 z1 1 cm2 where z Zbp centimeters zdp 1 69 Aarpt For MI zsp is the axtial distance at that pr0 3...

Страница 165: ...2 MHz B W Focus F4 F7 F6 F6 F6 B W Range cm 12 0 12 0 12 0 12 0 B W Line Density HIGH HIGH HIGH HIGH B W Scan Area 100 100 100 100 Doppler Image Select n a n a PENET n a Doppler Frequency Select MHz n...

Страница 166: ...a n a n a n a Doppler Frequency Select MHz n a n a n a n a n a n a Doppler Focus n a n a n a n a n a n a Doppler Velocity Range cm sec n a n a n a n a n a n a Color Image Select n a n a n a n a n a n...

Страница 167: ...W Scan Area n a n a n a n a n a n a Doppler Image Select PENET PENET PENET Doppler Frequency Select MHz 6 MHz 6 MHz 6 MHz Doppler Focus F5 F3 F7 Doppler Velocity Range cm sec 16 6 10 0 39 8 Color Ima...

Страница 168: ...an Area n a n a n a n a n a n a Doppler Image Select n a n a n a n a n a n a Doppler Frequency Select MHz n a n a n a n a n a n a Doppler Focus n a n a n a n a n a n a Doppler Velocity Range cm sec n...

Страница 169: ...General accuracy Round off accuracy Distance in B mode 3 0 01 cm 0 1 cm 10 cm distance 10 cm distance Area by trace in B mode 6 0 01 cm2 0 1 cm2 100 cm2 area 100 cm2 area Circumference by trace B mod...

Страница 170: ...xceed a TI of 1 0 in any mode Acoustic output table with Hitachi diagnostic ultrasound system The terms used in the acoustic output table are as follows Acoustic attenuation coefficient 12 dB output b...

Страница 171: ...Pulse pressure squared integral Peak rarefactional acoustic pressure Attenuated peak rarefactional acoustic pressure Pulse repetition rate Thermal index Bone thermal index Cranial bone thermal index...

Страница 172: ...IGH HIGH B W Scan Area 25 25 25 Doppler Image Select n a n a n a n a n a n a Doppler Frequency Select MHz n a n a n a n a n a n a Doppler Focus n a n a n a n a n a n a Doppler Velocity Range cm sec n...

Страница 173: ...0 B W Line Density HIGH HIGH HIGH HIGH B W Scan Area 25 25 25 25 Doppler Image Select n a n a n a n a n a n a Doppler Frequency Select MHz n a n a n a n a n a n a Doppler Focus n a n a n a n a n a n...

Страница 174: ...Line Density n a n a n a n a n a n a B W Scan Area n a n a n a n a n a n a Doppler Image Select n a n a n a n a n a n a Doppler Frequency Select MHz n a n a n a n a n a n a Doppler Focus n a n a n a n...

Страница 175: ...a n a n a B W Line Density n a n a n a n a n a n a B W Scan Area n a n a n a n a n a n a Doppler Image Select PENET PENET PENET PENET Doppler Frequency Select MHz 5MHz 6MHz 6MHz 6MHz Doppler Focus F1...

Страница 176: ...0 2 0 B W Line Density n a n a n a n a n a n a B W Scan Area n a n a n a n a n a n a Doppler Image Select n a n a n a n a n a n a Doppler Frequency Select MHz n a n a n a n a n a n a Doppler Focus n...

Страница 177: ...2 0 2 0 2 0 B W Line Density HIGH HIGH HIGH HIGH B W Scan Area 25 25 25 25 Doppler Image Select PENET PENET PENET PENET Doppler Frequency Select MHz 5MHz 6MHz 6MHz 6MHz Doppler Focus F1 F5 F3 F7 Doppl...

Страница 178: ...F5 F1 B W Range cm 12 0 8 0 2 0 B W Line Density HIGH HIGH HIGH B W Scan Area 25 25 25 Doppler Image Select n a n a n a n a n a n a Doppler Frequency Select MHz n a n a n a n a n a n a Doppler Focus n...

Страница 179: ...F5 F1 B W Range cm 12 0 8 0 2 0 B W Line Density HIGH HIGH HIGH B W Scan Area 25 25 25 Doppler Image Select n a n a n a n a n a n a Doppler Frequency Select MHz n a n a n a n a n a n a Doppler Focus...

Страница 180: ...Focus F3 F7 F1 F7 B W Range cm 10 0 2 0 2 0 2 0 B W Line Density HIGH HIGH HIGH HIGH B W Scan Area 25 25 25 25 Doppler Image Select PENET PENET PENET PENET Doppler Frequency Select MHz 6MHz 6MHz 6MHz...

Страница 181: ...174 Appendix D Acoustic Output Information Accordance with IEC 60601 2 37 ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF UC180F...

Страница 182: ...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 183: ...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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