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Appendix

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

EMC information

Guidance and manufacturer’s declaration — 
Electromagnetic emissions

This model is intended for use in the electromagnetic environment specified 
below. The customer or the user of this model should assure that it is used 
in such an environment.

Emissions test

Compliance

Electromagnetic environment — Guidance

RF emissions
CISPR 11

Group 1

This instrument uses RF (Radio Frequency) energy only for its 
internal 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 are very low and are not likely to 
cause any interference in nearby electronic equipment.

Main terminal 
conducted emissions
CISPR 11

Harmonic emissions
IEC 61000-3-2

Class A

This instrument’s harmonic emissions are low and are not likely to 
cause any problem in the typical commercial power supply connected 
to this instrument.

Voltage 
fluctuations/flicker 
emissions
IEC 61000-3-3

Complies

This instrument stabilizes its own radio variability and has no effect, 
such as flicker in lighting apparatus.

Содержание EVIS EXERA II

Страница 1: ...anual the OLYMPUS TJF TYPE Q180V REPROCESSING MANUAL for reprocessing information USA CAUTION Federal law restricts this device to sale by or on the order of a physician INSTRUCTIONS EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V ...

Страница 2: ......

Страница 3: ...andling 9 Chapter 1 Checking the Package Contents 10 Chapter 2 Instrument Nomenclature and Specifications 12 2 1 Nomenclature 12 2 2 Endoscope functions 14 2 3 Specifications 16 2 4 Attaching the chain for water resistant cap MAJ 1119 19 Chapter 3 Preparation and Inspection 22 3 1 Preparation of the equipment 23 3 2 Inspection of the endoscope 24 3 3 Preparation and inspection of accessories 28 3 ...

Страница 4: ...Withdrawal of the endoscope with an irregularity 68 5 3 Returning the endoscope for repair 70 Chapter 6 Inspection Schedule Related to Forceps Elevator 71 6 1 Inspection after each patient procedure 71 6 2 Inspection before each patient procedure 72 6 3 Annual inspection 72 Appendix 73 System chart 73 EMC information 84 ...

Страница 5: ...symbol s shown on the component packaging the back cover of the instruction manual and or the instrument are as follows Refer to instructions Caution Endoscope TYPE BF applied part Single use only Lot number Manufacturer Authorized representative in the European Community Serial number ...

Страница 6: ...icability 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 w...

Страница 7: ...fficial standards for user qualifications to perform endoscopy and endoscopic treatment that are defined by the hospital s medical administrators or other official institutions such as academic societies on endoscopy follow those standards If there are no official qualification standards the operator of this instrument must be a physician approved by the medical safety manager of the hospital or p...

Страница 8: ...2 1993 the whole system complies with edition 1 Reprocessing before the first use reprocessing and storage after use This instrument was not cleaned disinfected or sterilized before shipment Before using this instrument for the first time reprocess it according to the instructions given in the endoscope s companion REPROCESSING MANUAL with your endoscope model listed on the cover After using this ...

Страница 9: ...ccording to Chapter 6 Inspection Schedule Related to Forceps Elevator in the manual Prohibition of improper repair and modification This instrument does not contain any user serviceable parts Do not disassemble modify or attempt to repair it patient or operator injury and or equipment damage may result Equipment that has been disassembled repaired altered changed or modified by persons other than ...

Страница 10: ...ch glasses necklace etc from the patient Performing high frequency cauterization treatment while the patient is wearing metallic objects may cause burns on the patient in areas around the metallic objects Do not strike hit or drop the endoscope s distal end insertion tube bending section control section universal cord or endoscope connector Also do not bend pull or twist the endoscope s distal end...

Страница 11: ... the image is magnified Patient injury bleeding and or perforation can result when using the image magnification function of the video system center Do not touch the light guide on the endoscope connector immediately after removing it from the light source because it is extremely hot Operator or patient burns can result When the endoscopic image does not appear on the monitor the CCD may have been...

Страница 12: ...struction of the CCD The endoscope s remote switches cannot be removed from the control section Pressing pulling or twisting them with excessive force can break the switches and or cause water leaks If remote switch 1 does not return to the OFF position after being pressed strongly from the side gently pull the switch upwards to return it to the OFF position Do not hit or bend the electrical conta...

Страница 13: ...ble to straighten the angle of the bending section and or withdraw the endoscope from the patient Retroflexed observation in parts of the body other than the stomach should be performed only when the usefulness of doing so is determined to be greater than the risk that is posed to the patient Inserting withdrawing and using EndoTherapy accessories without a clear endoscopic image may cause patient...

Страница 14: ...tem for damage If the instrument is damaged a component is missing or you have any questions do not use the instrument immediately contact Olympus This instrument was not disinfected or sterilized before shipment Before using this instrument for the first time reprocess it according to the instructions described in the endoscope s companion REPROCESSING MANUAL with your endoscope model listed on t...

Страница 15: ...n tube MH 946 AW channel cleaning adapter MH 948 Channel opening cleaning brush MH 507 Channel plug MH 944 Air water valve MH 438 2 pcs Suction valve MH 443 2 pcs Reprocessing manual Biopsy valve MB 358 10 pcs Suction cleaning adapter MH 856 Operation manual Mouthpiece MB 142 2 pcs Instructions caution for locking the guidewire Single use soft brush MAJ 1888 5pcs ...

Страница 16: ...NUAL Chapter 2 Instrument Nomenclature and Specifications 2 1 Nomenclature 2 S cord connector mount Universal cord Air pipe Light guide Product name model and serial number 3 Water supply connector 3 Air supply connector 1 Suction connector 5 Electrical connector 4 Endoscope connector Contact pins ...

Страница 17: ...r 11 Insertion section limit mark Guidewire locking function mark 15 Color code orange Biopsy valve MB 358 Instrument channel port 10 Instrument channel 17 RIGHT LEFT angulation control knob 16 RIGHT LEFT angulation lock Grip section Guidewire locking function color blue Suction cylinder 8 Suction valve MH 443 9 Air water valve MH 438 6 UP DOWN angulation control knob 7 UP DOWN angulation lock 18 ...

Страница 18: ...ocket of the light source and transmits light from the light source to the endoscope 5 Electrical connector Connects the endoscope to the video system center via the videoscope cable The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV 180 CV 160 For more details refer to the instruction manual for the CV 1...

Страница 19: ...ches 1 to 4 The functions of remote switches 1 to 4 can be selected on the video system center Refer to the instruction manual for the video system center when setting these functions 15 Color code orange The endoscope can be used with EndoTherapy accessories that have the same color code For more information on combining the endoscope with particular EndoTherapy accessories refer to the System ch...

Страница 20: ...700 1060 hPa 0 7 1 1 kgf 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 Transportation environment conditions during transportation and short term storage Ambient temperature 47 to 70 C 52 6 to 158 F Relative humidity 10 95 Atmospheric pressure 700 1...

Страница 21: ...er nozzle 2 Objective lens 3 Light guide lens 4 Instrument channel outlet 5 Forceps elevator 6 Guidewire locking groove Insertion tube outer diameter ø 11 3 mm Insertion section working length 1240 mm Instrument channel Channel inner diameter ø 4 2 mm Minimum visible distance 10 mm Direction from which EndoTherapy accessories enter and exit the endoscopic image Airflow rate 25 cm3 s Note Standard ...

Страница 22: ...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 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 1993 the whole system complies with edition 1 Year of manufacture The l...

Страница 23: ...ctor do not pinch the chain for water resistant cap between the electrical connector of the endoscope and the water resistant cap Otherwise equipment damage may result The chain for water resistant cap and the water resistant cap itself cannot be ultrasonically cleaned doing so could damage them The water resistant cap with the chain can only be ultrasonically cleaned if it is connected to an endo...

Страница 24: ... is free from cracks flaws wear deformation 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 the venting connector see Figure 2 2 4 Confirm that the connecting plate is securely attached to the foot of the venting connector and can be smoothly rotated se...

Страница 25: ...tor mount see Figure 2 3 Figure 2 3 6 Confirm that the fitting part is securely attached to the foot of the S cord connector mount and can be smoothly rotated The instructions on the remaining pages of this manual are given under the assumption that the chain for water resistant cap is detached from the endoscope Hole S cord connector mount or chain connector Fitting part ...

Страница 26: ...d in Chapter 5 Troubleshooting If this instrument malfunctions do not use it Return it to Olympus for repair as described in Section 5 3 Returning the endoscope for repair on page 70 Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage This instrument was not cleaned disinfected or sterilized before shipment Be...

Страница 27: ...ersonal protective equipment such as eyewear face mask moisture resistant clothing and chemical resistant gloves that fit properly and are long enough so that your skin is not exposed Refer to the respective instruction manuals for each piece of equipment Figure 3 1 Lint free cloths Personal protective equipment Endoscope Monitor Water container Video system center Light source Suction pump Mouthp...

Страница 28: ...oles sagging transformation bends adhesion of foreign bodies missing parts protruding objects or other irregularities 4 Inspect the forceps elevator and the area which can be visually accessible in elevator recess while raising and lowering the forceps elevator to confirm that there is not any foreign materials such as debris and fluids but not limited to If any foreign materials are observed stop...

Страница 29: ...tly hold the midpoint of the bending section and a point 20 cm from the distal end Push and pull gently to confirm that the junction between the bending section and the insertion tube is not loose 8 Inspect the objective lens and light guide lens at the distal end of the endoscope s insertion section for scratches cracks stains or other irregularities 9 Inspect the air water nozzle at the distal e...

Страница 30: ...ection during an examination Inspection for smooth operation 1 Confirm that both the UP DOWN and RIGHT LEFT angulation locks move all the way in the F direction 2 Turn the UP DOWN and RIGHT LEFT angulation control knobs slowly in each direction until they stop and return them to their respective neutral positions Confirm that the bending section angulates smoothly and correctly that maximum angula...

Страница 31: ...e F mark Then turn the RIGHT LEFT angulation control knob in the R or the L direction until it stops 2 Confirm that the angle of the bending section is roughly stabilized when the RIGHT LEFT angulation control knob is released 3 Confirm that the bending section straightens out when the RIGHT LEFT angulation lock is turned in the F direction and the RIGHT LEFT angulation control knob is released In...

Страница 32: ... U direction Confirm that the lever can be operated smoothly and that the forceps elevator lowers smoothly see Figure 3 5 Figure 3 5 3 3 Preparation and inspection of accessories Clean and disinfect or sterilize the air water valve suction valve biopsy valve as described in the endoscope s companion REPROCESSING MANUAL with your endoscope model listed on the cover Inspection of the air water and s...

Страница 33: ...ching or tears in the air water valve s seals see Figure 3 6 Figure 3 6 Figure 3 7 The air water and suction valves are consumables If the inspection of the air water or suction valve reveals any irregularity use new valves Air water valve MH 438 Spring Hole Skirt Hole Seals Suction valve MH 443 Spring Skirt Hole ...

Страница 34: ...pection An irregular abnormal or damaged valve can reduce the efficacy of the endoscope s suction system and may leak or spray patient debris or fluids posing an infection control risk 1 Confirm that the slit and hole on the biopsy valve have no splits cracks deformations discoloration or other damage see Figure 3 8 Figure 3 8 2 Attach the cap to the main body see Figure 3 9 Figure 3 9 Normal Abno...

Страница 35: ...and or equipment damage Placing the mouthpiece in the patient s mouth before the procedure prevents the patient from biting and or damaging the endoscope s insertion section 1 Confirm that the mouthpiece is free from cracks deformations or discoloration see Figure 3 10 2 Using your fingers check all surfaces of the mouthpiece for scratches cracks or other irregularities see Figure 3 10 Figure 3 10...

Страница 36: ...the two metal ridges on the underside of the suction valve with the two holes in the suction cylinder 2 Attach the suction valve to the suction cylinder of the endoscope see Figure 3 11 and 3 12 Confirm that the valve fits properly without any bulging of the skirt Also confirm that the valve cannot be rotated Figure 3 11 The suction valve will make a whistling noise when it is dry this does not in...

Страница 37: ... stick at first but it should operate smoothly after it is depressed a few times Attaching the biopsy valve If a biopsy valve is not properly connected to the instrument channel port it can reduce the efficacy of the endoscope s suction system and leak or spray patient debris posing an infection control risk Attach the biopsy valve to the instrument channel port of the endoscope see Figure 3 13 Co...

Страница 38: ... and equipment malfunction can result Take care not to spill water from the water container s connection adapter when detaching the connection adapter from the endoscope Spilled water could splash on the equipment and may cause equipment malfunction Prepare and inspect the light source video system center monitor water container suction pump and EndoTherapy accessories as described in their respec...

Страница 39: ...e light source 3 Place the water container s water supply channel onto the water supply connector on the endoscope connector at an angle of 90 and push it in until it stops see Figure 3 14 1 4 Turn the water container s connection adapter 90 clockwise to align the air supply channel with the air supply connector on the endoscope connector see Figure 3 14 2 5 Push the water container s connection a...

Страница 40: ... 3 15 8 Turn the connector of the videoscope cable towards mark 2 until it stops see Figure 3 15 9 Confirm that the mark on the videoscope cable is aligned with mark 2 on the endoscope connector 10 Connect the suction tube from the suction pump to the suction connector on the endoscope connector see Figure 3 16 Figure 3 16 Mark 2 yellow Mark yellow Mark 1 yellow Videoscope cable Videoscope cable S...

Страница 41: ...your hand confirm that the WLI and NBI endoscopic image is free from noise blur fog or other irregularities 4 Angulate the endoscope and confirm that the WLI and NBI endoscopic images do not momentarily disappear or display any other irregularities If the object cannot be seen clearly wipe the objective lens using a clean lint free cloth moistened with 70 ethyl or 70 isopropyl alcohol Inspection o...

Страница 42: ...les is emitted from the air water nozzle even though the air water valve is not being operated and the distal end of the insertion section is 10 cm or more below the surface of the sterile water there may be an irregularity in the air feeding function If the endoscope is used while air is continuously fed over insufflation and patient injury may result If air bubbles are emitted from the air water...

Страница 43: ...While observing the endoscopic image confirm that the emission of water stops and that the valve returns smoothly to its original position 3 While observing the endoscopic image feed air after feeding water by covering the hole in the air water valve with your finger Confirm that the emitted air removes the remaining water from the objective lens and clears the endoscopic image Inspection of the s...

Страница 44: ...e instrument channel and forceps elevator Keep your eyes away from the distal end when inserting EndoTherapy accessories Extending the EndoTherapy accessory from the distal end could cause an eye injury Check the movement of the EndoTherapy accessory by operating the elevator control lever several times to raise the forceps elevator Otherwise the EndoTherapy accessory may move unexpected direction...

Страница 45: ...each 50 C 122 F due to intense endoscopic illumination Surface temperatures over 41 C 106 F may cause mucosal burns Always maintain a suitable distance necessary for adequate viewing while using the minimum level 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 ...

Страница 46: ... with an irregularity on page 68 Should any irregularity be observed with the functionality of the endoscope If the endoscopic image on the monitor disappears or freezes unexpectedly If the angulation control knob is locked If the angulation control mechanism is not functioning properly If the zoom malfunctions when using the image magnification function of the video system center CV 180 Continued...

Страница 47: ...he endoscope is used for a prolonged period at or near maximum light intensity vapor may be observed in the endoscopic image This is caused by the evaporation of organic material blood moisture in stool 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 endoscope wipe the distal end with a lint free cloth mois...

Страница 48: ...the endoscope Keep the elevator control lever moved all the way in the opposite direction of the U direction while inserting or withdrawing the endoscope into or from the patient If the elevator control lever is moved in the U direction until the operator feels heavy and the forceps elevator is raised while inserting or withdrawing the endoscope into or from the patient this may cause patient inju...

Страница 49: ...ithin a distance of 10 cm or less from the junction of the boot Insertion section damage can occur see Figure 4 2 Figure 4 2 1 Move the elevator control lever in the opposite direction of the U direction until it stops 2 If necessary apply a medical grade water soluble lubricant to the insertion section 3 Place the mouthpiece between the patient s teeth or gums with the outer flange on the outside...

Страница 50: ...OWN or RIGHT LEFT angulation lock hold the angulation control knob stationary with your finger If this is not done the angulation will change Air water feeding and suction If the sterile water level in the water container is too low then air not water will be supplied In this case turn the airflow regulator on the light source OFF and add sterile water to the water container until it reaches the s...

Страница 51: ... endoscope is cold condensation may form on the surface of the objective lens and the endoscopic image may appear cloudy In this case increase the temperature of the sterile water in the water container to 40 50 C 104 122 F and then use the endoscope Air water feeding 1 Cover the air water valve s hole to feed air from the air water nozzle at the distal end see Figure 4 3 2 Depress the air water v...

Страница 52: ...ating attach the cap to the main body of the biopsy valve An uncapped biopsy valve can reduce the efficacy of the endoscope s suction system and may leak or spray patient debris or fluids posing an infection control risk During the procedure make sure that the suction bottle does not fill completely Aspirating fluids into a full bottle may cause the suction pump to malfunction Depress the suction ...

Страница 53: ...accessory confirm that its distal end is closed or completely retracted into the sheath Slowly insert or withdraw the EndoTherapy accessory straight into or from the slit of the biopsy valve Otherwise the biopsy valve may be damaged and pieces of it could fall off If insertion or withdrawal of EndoTherapy accessories is difficult straighten the bending section as much as possible without losing th...

Страница 54: ...rforming papillotomy When the distal end of EndoTherapy accessory is positioned in the left or right side of the endoscopic image and the elevator control lever is operated the EndoTherapy accessory may move abruptly resulting in patient injury bleeding and or perforation Operate the elevator control lever carefully Otherwise the EndoTherapy accessory may move unexpected directions and patient inj...

Страница 55: ...of the endoscope abruptly which could cause patient injury bleeding and or perforation When the biopsy valve s cap is detached from the main body it is easier to insert an EndoTherapy accessory into the instrument channel port see Figure 3 9 on page 30 However the open biopsy valve after withdrawing an EndoTherapy accessory can reduce the efficacy of the endoscope s suction system and may leak or ...

Страница 56: ...insert the EndoTherapy accessory slowly and straight into the slit of the biopsy valve Do not open the tip of the EndoTherapy accessory or extend the tip of the EndoTherapy accessory from its sheath while the accessory is in the instrument channel The instrument channel and or the EndoTherapy accessory may become damaged 5 Hold the EndoTherapy accessory approximately 4 cm from the biopsy valve and...

Страница 57: ... tip of the EndoTherapy accessory and or retract it into its sheath 2 While lowering the forceps elevator gradually slowly withdraw the EndoTherapy accessory Locking the guidewire The TJF Q180V is designed to lock the guidewire in place during wire guided type EndoTherapy accessory withdrawal or insertion such as when a guidewire has been placed through a cannulation device into the biliary or pan...

Страница 58: ...e distal end of the endoscope moves suddenly and patient pain injury bleeding and or perforation may result Insert the guidewire into the biliary pancreatic duct sufficiently when the guidewire is retained there If the guidewire is not locked at the distal end of the endoscope with sufficient insertion the guidewire can be withdrawn from the biliary pancreatic duct This may cause patient injury bl...

Страница 59: ...wire is still stuck in the guidewire locking groove contact Olympus without changing the position of the instrument The maximum angle of the forceps elevator is slightly increased compared to duodenoscopes without the assist function of the guidewire locking due to the necessity to lock the guidewire at the distal end Therefore EndoTherapy accessories can be raised higher than with other duodenosc...

Страница 60: ...tively with guidewires with a diameter of ø 0 64 mm 0 025 inch or more The assist function of the guidewire locking may not work effectively due to various shapes and sizes of the patient s duodenum biliary duct and pancreatic duct The assist function of the guidewire locking may not work effectively under the following conditions If the elevator control lever is not held stationary If the proxima...

Страница 61: ...rating the elevator control lever This does not indicate a malfunction When the assist function of the guidewire locking does not work effectively using a guidewire with a length of less than 4 5 m may make it difficult to exchange the wire guided type EndoTherapy accessories Prepare the guidewire with a length of 4 5 m or more Using a guidewire with a length of 4 5 m or more wire guided type Endo...

Страница 62: ...bserving the endoscopic and X ray images 3 When only the guidewire is extended from the endoscope s distal end slowly move the elevator control lever in the U direction until the operator feels heavy with the papilla observed in the gray colored area of the endoscopic image shown in the Figure 4 4 for center lock see Figure 4 5 Alternatively when only the guidewire is extended from the endoscope s...

Страница 63: ...re effectively The assist function of the guidewire locking works more effectively when the papilla is observed on the left side of endoscopic image 5 Withdraw the EndoTherapy accessory slowly while holding the elevator control lever stationary so that the elevator and guidewire do not move forward to the U direction Observe the endoscopic and X ray images while withdrawing the accessory Guidewire...

Страница 64: ...tion of the distal end of the endoscope and the papilla which may impair the assist function of the guidewire locking In this case change the position of the distal end see Figure 4 8 Figure 4 8 a X ray image when a locking is effective b X ray image when a locking is not effective Guidewire Papilla Guidewire Papilla Guidewire Guidewire Forceps elevator Forceps elevator ...

Страница 65: ... EndoTherapy accessory slowly from the proximal end of the guidewire while observing the endoscopic and X ray images 3 When the tip of the wire guided type EndoTherapy accessory comes in contact with the forceps elevator move the elevator control lever in the opposite direction of the U direction to lower the forceps elevator while observing the endoscopic image 4 While observing endoscopic and X ...

Страница 66: ...ribed in their instruction manuals The application of high frequency current may interfere with the endoscopic image This does not indicate a malfunction When the endoscope is used with the electrosurgical unit ESG 100 it is not necessary to use the S cord 4 3 Withdrawal of the endoscope If blood unexpectedly adheres to the surface of the insertion section of the withdrawn endoscope carefully chec...

Страница 67: ...clean disinfect or sterilize the endoscope after removing it from the carrying case If the endoscope is not cleaned disinfected or sterilized it could pose an infection control risk The carrying case cannot be cleaned disinfected or sterilized Clean and disinfect or sterilize the endoscope before placing it in the carrying case To avoid damage to the endoscope caused by changes in air pressure do ...

Страница 68: ...ay result in more severe equipment damage If any parts of the endoscope fall off inside the patient body due to equipment damage or failure stop using the endoscope immediately and retrieve the parts in an appropriate way Should any irregularity in the function of the endoscope and or endoscopic image be observed during use stop the examination immediately and carefully withdraw the endoscope from...

Страница 69: ...ve is damaged Replace it with a new one No water feeding The air pump is not operating Press the LOW MED HIGH button on the light source as described in the light source s instruction manual There is no sterile water in the water container Add sterile water to fill the container to the specified water level The air water valve is damaged Replace it with a new one The air water valve is sticky The ...

Страница 70: ... one The suction valve cannot be attached The suction valve is damaged Replace it with a new one An incompatible suction valve is used Use a compatible suction valve Liquid leaks out of the biopsy valve The biopsy valve is damaged Replace it with a new one The biopsy valve is not attached properly Attach it correctly Irregularity description Possible cause Solution There is no video image Not all ...

Страница 71: ...ff part Guidewire with a diameter less than ø 0 64 mm is used Select a guidewire with a diameter of ø 0 64 mm or more Guidewire locking groove is dirty Clean and disinfect or sterilize the guidewire locking groove as described in the REPROCESSING MANUAL with your endoscope model listed on the cover Contrast media is congealed in the guidewire lumen of the EndoTherapy accessory Clean the lumen of t...

Страница 72: ...ing the endoscope or EndoTherapy accessory may cause patient injury bleeding and or perforation If any irregularities with the scope are observed contact Olympus Withdrawal when the WLI and NBI endoscopic images appear on the monitor 1 Turn all equipment OFF except the video system center light source monitor and suction pump 2 When the NBI endoscopic image is displayed switch to the WLI endoscopi...

Страница 73: ...and then ON again If the WLI or NBI endoscopic image appears or the frozen image is restored follow the procedure given in Withdrawal when either the WLI or the NBI endoscopic image does not appear on the monitor beginning from Step 2 If no endoscopic image still appears or the frozen image cannot be restored perform the following steps 3 Turn the video system center light source monitor and sucti...

Страница 74: ...ol risk to each person who handles the endoscope within the hospital and at Olympus Before returning the endoscope for repair contact Olympus With the endoscope include a description of the malfunction or damage and the name and telephone number of the individual at your location who is most familiar with the problem Also include a repair purchase order When returning the endoscope for repair foll...

Страница 75: ...ting Otherwise detecting leaks which occur only when the forceps elevator is raised or lowered may be impossible Use of an endoscope with a leak may pose an infection control risk 2 Clean the forceps elevator and elevator recess according to the instructions described in Brush and flush the forceps elevator recess in Section 5 4 Manually cleaning the endoscope and accessories in the REPROCESSING M...

Страница 76: ...d fluids are observed do not use the endoscope confirm if there is no deviation in cleaning and reprocessing procedure from the protocol given in the REPROCESSING MANUAL take corrective action s if necessary and perform reprocessing again according to the REPROCESSING MANUAL If residual foreign materials such as debris is still observed after the repeated reprocessing do not use the endoscope and ...

Страница 77: ...ndoscope 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 the endoscope For further details contact Olympus If combinations of equipment other than those shown below are used full responsibility is assumed by the medical treatment facility ...

Страница 78: ... cable 100 MH 976 1 MD 148 1 EVIS video system center CV 140 EVIS universal light source CLV U40 Videoscope cable EXERA MAJ 843 EVIS EXERA video system center CV 160 EVIS EXERA light source CLV 160 Videoscope cable EXERA II MAJ 1430 EVIS EXERA II video system center CV 180 EVIS EXERA II light source CLV 180 SSU 2 ...

Страница 79: ...Electrosurgical accessories Refer to the following pages Refer to the following pages Electrosurgical unit PSD 60 Mouthpiece MB 142 Water container MAJ 901 Argon plasma coagulation unit ENDOPLASMA APC probe MAJ 1011 1 MAJ 1012 1 These products may not be available in some areas H V100 ET control device ESG 100 Electrosurgical unit ...

Страница 80: ...thermo disinfector ETD system 1 Channel plug MH 944 AW channel cleaning adapter MH 948 Leakage tester MB 155 Water resistant cap MH 553 Channel opening cleaning brush MH 507 Injection tube MH 946 Suction cleaning adapter MH 856 Single use channel opening cleaning brush MAJ 1339 1 Channel cleaning brush BW 20T Chain for water resistant cap MAJ 1119 Cleaning and disinfection equipment 1 These produc...

Страница 81: ...at tooth Basket type Flower basket type TJF Q180V BC 23Q BC 24Q FG 14P 1 FG 18Q 1 FG 22Q 1 FG 23Q 1 FG 301Q Endoscope Disposable grasping forceps Grasping forceps Rotatable grasping forceps Flower basket type Basket type Rubber tips Non latex Rat tooth with alligator jaws TJF Q180V FG 401Q FG 402Q FG 403Q FG 20P 1 FG 44NR 1 Endoscope Disposable rotatable grasping forceps Disposable grasping forcep...

Страница 82: ...tor Slide type Slide type Slide type Guidewire type TJF Q180V BML 202Q BML V232QR 26 BML 203Q BML 204Q BML V437QR 30 BML V442QR 30 Endoscope Cannula Standard type Metal tip type Hard type Slit type TJF Q180V PR 104Q 1 PR 304Q PR 128Q 1 PR 108Q 1 PR 126Q 1 PR 326Q Endoscope Cannula Short taper type Long taper type Ball tip type Side hole type TJF Q180V PR 109Q 1 1 PR 113Q 1 PR 309Q PR 313Q PR 110Q ...

Страница 83: ... taper type TJF Q180V PR 227Q PR 427Q PR V227Q PR V427Q PR V234Q PR V235Q PR V434Q PR V435Q PR 214Q PR 218Q PR 225Q PR 414Q PR 418Q PR V214Q PR V218Q PR V414Q PR V418Q PR V614M PR 220Q PR 420Q PR V220Q PR V420Q Endoscope Disposable cannula Disposablebending cannula Washing pipe Ball tip type Metal tip type Spray type TJF Q180V PR 23Q PR V223Q PR 231Q 1 PR 232Q 1 PR 233Q PW 5V 1 PW 6P 1 1 These acc...

Страница 84: ...Fr 10 Fr TJF Q180V PBD 422 PBD V622R PBD 200 PBD V600R PBD 201 PBD V601R PBD 202 PBD V602R Endoscope Biliary drainage tube Nasal biliary drainage tube 7 Fr 5 Fr 7 Fr Short type Pigtail type type TJF Q180V PBD 203 PBD 20Z PBD 24Z PBD 21Z PBD 25Z PBD 22Z PBD 26Z Endoscope Nasal biliary drainage tube 7 Fr 5 Fr Single use nasal biliary drainage tube 5 Fr 6 Fr 7 Fr Reverse type type Reverse type Pigtai...

Страница 85: ... biliary drainage tube 5 Fr 6 Fr 7 Fr Pancreatic stent short type Pigtail type 7Fr 7Fr 8 5Fr 10Fr TJF Q180V PBD V814W PBD V803W PBD 230 PBD 234 Endoscope Balloon catheter Biliary balloon dilator Guide catheter TJF Q180V B7 2LA B5 2LA B 230Q A B 230Q B B V231P A B V231P B B 400N MD 984 ...

Страница 86: ...e Pull type TJF Q180V KD 29Q 1 KD 6G10Q 1 to KD 6G18Q 1 KD 200Q KD 201Q Endoscope Disposable papillotomy knife Wire guided type Triple lumen sphincterotome Disposable triple lumen sphincterotome Pull type Clever Cut Pull type Clever Cut Pull type Pull type TJF Q180V KD 210Q KD 211Q KD V211M KD 301Q KD 321Q KD 401Q KD 421Q Endoscope Disposable triple lumen sphincterotome Single use triple lumen nee...

Страница 87: ... II TJF TYPE Q180V OPERATION MANUAL Endoscope Disposable guidewire TJF Q180V G V210 3545S G V210 3527S G V210 3545A G V210 3527A G 240 2527S G 240 2545S G 240 3527S G 240 3545S G 240 2527A G 240 2545A G 240 3527A G 240 3545A ...

Страница 88: ...ion 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 are not likely to cause any interference in nearby electronic equipment Main terminal conducted emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Class A This instrument s harmonic emissions are...

Страница 89: ...al 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 typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle Same as left Mains powe...

Страница 90: ...es 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 frequency electrosurgical equipment and or other equipment marked with the following symbol Immunity test IEC 60601 test level Compliance level Electromagnetic environment Guidance Recommended separ...

Страница 91: ...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 measured field strength in the location in which this model is used exceeds the applicable RF compliance level above this model should be observed to verify normal operation If abnormal performance is ...

Страница 92: ... 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 people Rated maximum output power of transmitter P W Separation distance according to frequency of transmitter m calculated as V1 3 and E1 3 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz 0 01 0 12 0 12 0 2...

Страница 93: ...e 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 used in this document are generally registered trademarks or trademarks of each company ...

Страница 94: ... 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 P R C Fax 86 10 5976 1299 Telephone 86 10 5819 9000 117071 Moscow Malaya Kaluzhskaya 19 bld 1 fl 2 Russia Fax 095 958 2277 Telephone 095 958 2245 3 Acacia Place Notting Hill VIC 3168 Australia Fax 03...

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