BF-F260 EVIS LUCERA BRONCHOVIDEOSCOPE Operation Manual

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

2

Intended use ...

2

Applicability of endoscopy and endoscopic treatment ...

2

Instruction manual...

3

User qualifications ...

3

Instrument compatibility ...

4

Reprocessing before the first use/reprocessing and storage after use ...

4

Spare equipment ...

4

Maintenance management ...

4

Prohibition of improper repair and modification...

5

Signal words ...

5

Warnings and cautions ...

5

Precaution for disappeared or frozen endoscopic image...

10

Examples of inappropriate handling ...

11

Chapter 1

Checking the Package Contents...

12

Chapter 2

Instrument Nomenclature and Specifications ...

14

2.1

Nomenclature...

14

2.2

Endoscope functions...

16

2.3

Specifications...

17

2.4

Attaching the chain for water-resistant cap (MAJ-1193) ...

20

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 ...

26

3.4

Attaching accessories to the endoscope ...

29

3.5

Inspection and connection of ancillary equipment ...

31

3.6

Inspection of the endoscopic system ...

33

Operation ...

37

4.1

Insertion ...

39

4.2

Using endo-therapy accessories...

43

4.3

Withdrawal of the endoscope...

51

4.4

Transportation of the endoscope ...

51

Chapter 3

Chapter 4

BF TYPE F260 OPERATION MANUAL

i

Contents

Chapter 5

ii

Troubleshooting ...

53

5.1

Troubleshooting guide ...

54

5.2

Withdrawal of the endoscope with an abnormality...

57

5.3

Returning the endoscope for repair...

59

Appendix...

60

System chart ...

60

EMC information...

66

BF TYPE F260 OPERATION MANUAL

Symbols

Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows:

Refer to instructions.

Caution

Endoscope

TYPE BF applied part

Lot number

Do not reuse.

Use by (expiration date)

Sterilization lot number

Sterilized using irradiation

Manufacturer

Authorized representative in the European Community

Serial number

BF TYPE F260 OPERATION MANUAL

1

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Do not use this instrument for any purpose other than its intended use.

Applicability of endoscopy and endoscopic treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions such as academic societies on endoscopy or pulmonology, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risk (their natures, 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 the 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.

2

BF TYPE F260 OPERATION MANUAL

Important Information - Please Read Before Use

Instruction manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. Note that the complete instruction manual set for this endoscope consists of this manual and the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. Both manuals accompany the endoscope at shipment. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

 Terms used in this manual AFI (Auto-Fluorescence Imaging) observation This is one special light observation method and features the use of blue illumination. WLI (White Light Imaging) observation This is a normal observation method using the standard RGB illumination.

User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions such as academic societies on endoscopy or pulmonology, follow that standard. If there is no official qualification standard, the operator of this instrument 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 performing the planned endoscopy and endoscopic treatment by following guidelines set by academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment.

BF TYPE F260 OPERATION MANUAL

3

Important Information - Please Read Before Use

Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient or operator injury and/or equipment damage. This instrument complies with EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007). However, when connected with an instrument that complies with EMC standard for medical electrical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1. (see “EMC information” on page 66 for EMC compliance level).

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 manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.

Spare equipment Be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.

Maintenance management The probability of failure of endoscope and ancillary equipment increase as the total operation cause and/or total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically. An endoscope with which an irregularity is suspected should not be used, but should be inspected by following Section 5.1, “Troubleshooting guide” on page 54. If the irregularity is still suspected after inspection, contact Olympus before use.

4

BF TYPE F260 OPERATION MANUAL

Important Information - Please Read Before Use

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 can result. Equipment which has been disassembled, repaired, altered, changed or modified by 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 throughout this manual:

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

Indicates additional helpful information.

Warnings and cautions Follow the warnings and cautions given below when handling this instrument. This information is to be supplemented by the warnings and cautions given in each chapter.

•

Do not perform laser cauterization treatment under AFI observation. Otherwise, the noise hinders the observation of the treated region, and injury, burns, bleeding or perforation in the body cavity may result.

•

After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

BF TYPE F260 OPERATION MANUAL

5

Important Information - Please Read Before Use

6

•

Before endoscopy, remove any metallic objects (watch, glasses, necklace, etc.) from the patient. If performing high-frequency cauterization treatment becomes necessary, while the patient wears a metallic object, it may cause burns on the patient in areas around the metallic object.

•

Do not strike, bend, hit, pull, twist, or drop the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force. The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation. It could also cause parts of the endoscope to fall off inside the patient.

•

Never perform angulation forcibly or suddenly. Never forcefully pull or twist the angulated bending section. Patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during use and/or to withdraw this instrument from the patient. Particular caution is required in the tracheal bifurcation region.

•

Never insert or withdraw the endoscope while the endoscope’s bending section is locked in position. When withdrawing the endoscope, the bending section should follow the form of the body cavity as much as possible. Otherwise, patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during use and/or to withdraw this instrument from the patient.

•

Never use endo-therapy accessories, operate the bending section, perform suction, insert or withdraw the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.

•

Never use endo-therapy accessories, operate the bending section, perform suction, insert or withdraw the endoscope’s insertion tube, while the image is frozen. Patient injury can result.

•

Never insert or withdraw the insertion tube suddenly, abruptly or with excessive force. Patient injury, bleeding and/or perforation can result.

•

If it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the endoscopy. Forcible insertion can result in patient injury, bleeding and/or perforation.

BF TYPE F260 OPERATION MANUAL

Important Information - Please Read Before Use

•

The shape and size of the nasal cavity and its suitability for transnasal insertion may vary from patient to patient. No endoscope, including this one, can always be inserted transnasally with all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw.

•

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 the endoscope. In this case, do not use force to withdraw the endoscope because patient injury such as bleeding or perforation may result.

•

Transnasal insertion is accompanied by the risk of bleeding in the nasal cavity. Be sure to be prepared to deal with any bleeding. When withdrawing the endoscope, observe the inside of the nasal cavity to ensure that there is no bleeding. Even when the endoscope has been withdrawn without bleeding, do not allow the patient to blow his or her nose strongly because this could cause it to start bleeding.

•

Before transnasal insertion, apply the appropriate pretreatment and lubrication to the patient to enlarge the nasal cavity. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw. Otherwise, the treatment will have no effect. The effects of the pretreatment agent and lubricant will decrease the longer the procedure lasts. Apply the pretreatment agent or lubricant as required during the procedure – for example, when withdrawal seems to be difficult.

•

Transnasal insertion of the endoscope should be performed carefully. If resistance to insertion is felt, or the patient reports pain, stop insertion immediately. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw.

•

If it becomes impossible to withdraw the transnasally inserted endoscope, pull its distal end out of the mouth, cut the flexible tube using wire cutters and, after ensuring that the cut section will not injure the body cavity or nasal cavity of the patient, withdraw the endoscope carefully. Therefore, always prepare wire cutters in advance.

BF TYPE F260 OPERATION MANUAL

7

Important Information - Please Read Before Use

•

When the endoscopic image (WLI observation mode or AFI observation mode) does not appear on the monitor, the CCD may have been damaged. Turn the video system center OFF immediately. Continuing power supply in such a case will cause the distal end to become hot and could cause operator and/or patient burns.

•

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 patient burns can result.

•

Do not rely on the AFI imaging modality alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.

•

Generally reprocessing agents1 are aggressive and might effect the distal end of the endoscope. When the effect progresses, fogging of the inner lenses might appear, which result in a foggy video image. Any further use of the endoscope under this condition might lead to parts of the endoscope (e.g. lens) to come off. Before inserting the endoscope to a patient, make sure that there is no fogging by checking the video image, and by wiping the outer surface of the lens at the distal end of the endoscope with a soft cloth. In case fogging appears, please stop using the endoscope immediately.

1 Contact Olympus for the names of specific brands that have been tested for compatibility with the endoscope.

8

•

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 not be visible.

•

Do not coil the insertion tube or universal cord into a diameter of less than 12 cm. Equipment damage can result.

•

Do not attempt to bend the endoscope’s insertion tube with excessive force. Otherwise the insertion tube may be damaged.

•

Do not touch the electrical contacts inside the electrical connector. CCD damage may result.

•

Do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end. Visual abnormalities may result.

BF TYPE F260 OPERATION MANUAL

Important Information - Please Read Before Use

•

Do not twist or bend the bending section with your hands. Equipment damage may result.

•

Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leaks.

•

Turn the video system center OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Turn the video system center ON or OFF only when the videoscope cable is connected to both the video system center and the electrical connector on the endoscope. Failure to do so can result in equipment damage, including destruction 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 may cause water leaks.

•

Do not hit or bend the electrical contacts on the endoscope connector. The connection to the light source may be impaired and faulty contact can result.

•

Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.

•

Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-260SL.

BF TYPE F260 OPERATION MANUAL

9

Important Information - Please Read Before Use

Precaution for disappeared or frozen endoscopic image •

If the endoscopic image unexpectedly disappears or a frozen image cannot be restored during an examination, immediately stop using the instrument and withdraw the endoscope from the patient. Continued use of the endoscope in such condition may cause patient injury, bleeding and/or perforation.

•

Follow the precautions given below when handling the instrument. Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.  Connect the endoscope connector, videoscope cable and video system center. Otherwise, faulty contact can result.  Do not bend, hit or twist the insertion section, control section, universal cord and endoscope connector. The endoscope may be damaged and water leaks and/or breakage of internal parts like the CCD cable can result.  Before inserting the endoscope, place the mouthpiece in the patient’s mouth in order to prevent the patient from accidentally biting the insertion section. Biting the insertion section may result in breakage of the CCD cable or light guide as well as damage to the insertion tube.  Before immersing the endoscope, always attach the water-resistant cap (MH-553). Otherwise, water will enter the endoscope and may cause a short circuit. This may result in CCD damage.  If bubbles emerge from the endoscope continuously during the leakage test, do not use the endoscope. Water may enter the instrument and cause a short circuit. This may result in CCD damage.

•

10

Turn the video system center OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Turn the switch ON or OFF only when the videoscope cable is connected to both the video system center and electrical connector on the endoscope. Failure to do so can result in equipment damage, including destruction of the CCD.

BF TYPE F260 OPERATION MANUAL

Important Information - Please Read Before Use

•

Do not touch the electrical contacts inside the electrical connector. CCD damage may result.

•

Do not hit or bend the electrical contacts on the endoscope connector. The connection to the light source may be impaired and faulty contact can result.

Examples of inappropriate handling Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility. Examples of inappropriate handling are given below. •

Applying prolonged suction with the distal end in contact with the mucosal surface, with higher suction pressure than required or with prolonged suction time may cause bleeding and/or lesions.

•

The endoscope has not been designed for use in retroflexed observation. Performing retroflexed observation in a narrow lumen may make it impossible to straighten the bending section and/or withdraw the endoscope from the patient. In case the patient moves due to coughing and other reasons while the endoscope is angulated in the narrow lumen, the bending section of the endoscope may be pushed into the lumen and be retroflexed. Pretreatment to control patient’s coughing reflex and other possible unexpected moves is the responsibility of trained specialists.

•

Inserting, withdrawing and using endo-therapy accessories without a clear endoscopic image may cause patient injury, bleeding, burns and/or perforation.

•

Inserting or withdrawing the endoscope, applying suction or operating the bending section without a clear endoscopic image may cause patient injury, bleeding and/or perforation.

BF TYPE F260 OPERATION MANUAL

11

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item 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 given in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.

Endoscope

Channel cleaning brush (BW-15B)

Cap chain (MAJ-1193)

Channel-opening cleaning brush (MH-507)

Suction valve (MAJ-207, 10 pcs)

Biopsy valve (MD-495, 10 pcs)

Suction cleaning adapter (MAJ-222)

Mouthpiece (MA-651, 2 pcs)

12

Water-resistant cap (MH-553)

Operation manual

BF TYPE F260 OPERATION MANUAL

Reprocessing manual

Chapter 1 Checking the Package Contents

BF TYPE F260 OPERATION MANUAL

13

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

Water-resistant cap (MH-553)

Venting connector Universal cord

Cap chain (MAJ-1193) 2. Electrical connector

Serial number Contact pins 1. Endoscope connector Light guide

14

BF TYPE F260 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

4. Suction valve

Suction cylinder

3. UP/DOWN angulation control lever

10. Identification mark for STERRAD® 200/NX material compatibility

Slit Control section

5. Biopsy valve

Instrument channel 6. Instrument channel port

7. Color code

Boot

Insertion tube/working length

9. Remote switches Suction cylinder

Distal end 8. Bending section

9. Remote switches Top view

BF TYPE F260 OPERATION MANUAL

15

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Endoscope connector This connector connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope. 2. Electrical connector This 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-260SL. For more details, refer to the instruction manual of the CV-260SL. 3. UP/DOWN angulation control lever When this lever is turned in the “U” direction, the bending section moves UP. When the lever is turned in the “D” direction, the bending section moves DOWN. 4. Suction valve (MAJ-207) This valve is depressed to activate suction. The valve is used to remove any fluid and debris that obstruct the visual field.

Use of the suction valve (MAJ-207) is not recommended for more than 6 procedures. 5. Biopsy valve (MD-495) Accessories may be inserted through the slit in this valve. A syringe may be inserted for the introduction of fluids.

Use of the biopsy valve (MD-495) is not recommended for more than 6 procedures. 6. Instrument channel port This channel port functions as:  channel for the insertion of endo-therapy accessories  suction channel  fluid feed channel (from a syringe via the biopsy valve) 7. Color code This code is used to quickly determine the compatibility of endo-therapy accessories. The endoscope can be used with endo-therapy accessories that have the same color code. Blue:

16

BF-F260

BF TYPE F260 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

8. Bending section This section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated. 9. Remote switches The functions of the remote switches 1 to 4 can be selected on the video system center. When selecting the functions, refer to the instruction manual for the video system center. 10. Identification mark for STERRAD® 200/NX material compatibility This mark indicates that this endoscope has material compatibility with the STERRAD® 200/NX Sterilization System. The endoscope without this mark is not applicable to STERRAD® 200/NX

2.3

Specifications Environment Operating environment

Ambient temperature

10 – 40C (50 – 104F)

Relative humidity

30 – 85%

Atmospheric pressure

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 Ambient temperature environment Relative humidity (conditions during Atmospheric pressure transportation and short-term storage)

–47 to 70C (–52.6 to 158F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

BF TYPE F260 OPERATION MANUAL

17