Instructions
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Page 1
INSTRUCTIONS
OES BRONCHOFIBERSCOPE
OLYMPUS BF TYPE XP60 OLYMPUS BF TYPE MP60 OLYMPUS BF TYPE P60 OLYMPUS BF TYPE 1T60
Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” which cover lists the model of your endoscope for reprocessing information.
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 ...
3
Reprocessing before the first use/reprocessing and storage after use...
4
Maintenance management ...
4
Repair and modification ...
4
Signal words...
5
Warnings and cautions ...
5
Examples of inappropriate handling...
8
Chapter 1
Checking the Package Contents...
9
Chapter 2
Instrument Nomenclature and Specifications ...
10
2.1
Nomenclature...
10
2.2
Endoscope functions...
12
2.3
Specifications...
13
Preparation and Inspection ...
17
3.1
Preparation of the equipment...
18
3.2
Inspection of the endoscope ...
19
3.3
Preparation and inspection of accessories ...
22
3.4
Attaching accessories to the endoscope ...
25
3.5
Inspection and connection of the ancillary equipment ...
27
3.6
Inspection of the endoscopic system ...
28
Operation ...
31
4.1
Insertion ...
32
4.2
Using endo-therapy accessories...
36
4.3
Withdrawal of the endoscope...
45
4.4
Transportation of the endoscope ...
46
Troubleshooting ...
47
5.1
Troubleshooting guide ...
47
5.2
Withdrawal of the endoscope with an abnormality...
49
Chapter 3
Chapter 4
Chapter 5
BF TYPE 60 Series OPERATION MANUAL
i
Contents
5.3
ii
Returning the endoscope for repair...
50
Appendix...
51
System chart ...
51
EMC information...
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BF TYPE 60 Series 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
Lot number
Type BF applied part
Endoscope
Do not reuse.
Use by (expiration date)
Sterilization lot number
Sterilized using irradiation
Manufacturer
Authorized representative in the European Community
Serial number
BF TYPE 60 Series OPERATION MANUAL
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Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use These instruments have been designed to be used with an Olympus light source, documentation equipment, video monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree. Do not use these instruments for any purpose other than their 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.
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BF TYPE 60 Series 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. It also accompanied 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.
User qualifications If there is an official standard on the qualification of endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions such as the academic society on endoscopy, follow the 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 medical safety manager of the hospital or person in charge of the department should select a physician who is capable of safely performing the planned endoscopy and endoscopic treatment by following the official guidelines set by the academic society on endoscopy, etc., and considering the difficulty of each type of endoscopy and endoscopic treatment.
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). 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.
BF TYPE 60 Series OPERATION MANUAL
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Important Information - Please Read Before Use
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 reprocessing manual. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.
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”. If the irregularity is still suspected after inspection, contact Olympus before use.
Repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result. This instrument is to be repaired by Olympus technicians only.
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BF TYPE 60 Series OPERATION MANUAL
Important Information - Please Read Before Use
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.
•
Never perform electrosurgery with BF-XP60/MP60, because the distal ends of these instruments are not insulated. Patient injury can result.
•
Never use a BF-60 series endoscope, OVC-100, CV-100, and ENDOPLASMA together, because the endoscopic image may disappear intermittently.
•
Never perform argon plasma coagulation with BF-XP60/MP60, because the distal end of these instruments is not insulated. Patient injury can result.
•
The BF-XP60 does not correspond to laser cauterization. Using the BF-XP60, for laser cauterization damages the end scope and cause patient injury.
•
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 60 Series OPERATION MANUAL
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Important Information - Please Read Before Use
6
•
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 operate the bending section, perform suction, insert or withdraw the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.
•
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 without viewing the endoscopic image. Patient injury can result.
•
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.
•
Never insert or withdraw the insertion tube suddenly, abruptly or with excessive force. Patient injury, bleeding and/or perforation can result.
•
Be sure to prepare another endoscope to avoid that the examination be interrupted due to equipment failure or malfunction.
•
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.
BF TYPE 60 Series OPERATION MANUAL
Important Information - Please Read Before Use
•
Do not coil the insertion tube or universal cord into a diameter of less than 12 cm. Equipment damage can 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.
•
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.
•
Do not scratch the electrical contacts of the eyepiece section with tweezers or other sharp instruments. Faulty contact with the camera equipment can 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.
•
Do not attempt to bend the endoscope’s insertion tube with excessive force. Otherwise, the insertion tube may be damaged.
•
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.
It is highly desirable that a backup endoscope be available to continue clinical procedures in case of a malfunction.
BF TYPE 60 Series OPERATION MANUAL
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Important Information - Please Read Before Use
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.
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•
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 60 Series OPERATION MANUAL
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
MAJ-207
Suction valve (MAJ-207, 10 pcs)
Channel cleaning brush (BW-15B (not for BF-XP60))
Single-use biopsy valve (MAJ-210, 20 pcs) Suction cleaning adapter (MAJ-222) Channel-opening cleaning brush (MH-507)
Channel cleaning brush (BW-7B (for BF-XP60))1
Suction connector cleaning brush (BW-15SH (for BF-XP60))
Mouthpiece (MA-651, 2 pcs)
Single use single-ended cleaning brush (BW-400B (for BF-XP60))1
ETO cap (MB-156)
Operation manual
Reprocessing manual
1 These products may not be available in some areas. BF TYPE 60 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature
Universal cord
Venting connector
Serial number
Electrical contacts Light guide
1. Endoscope connector
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BF TYPE 60 Series OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
Electrical contacts
3. Eyepiece frame (Viewfinder) 4. Diopter adjustment ring
Eyepiece section MAJ-207
5. Suction valve (MAJ-207)
2. UP/DOWN angulation control lever
Suction valve housing
Slit Control section
6. Single-use biopsy valve (MAJ-210)
7. Instrument channel 10. Identification mark for STERRAD® 200/NX material compatibility
Instrument channel port
8. Color code
Boot Insertion tube/working length
Distal end 9. Bending section
BF TYPE 60 Series OPERATION MANUAL
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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. 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. 3. Eyepiece frame (Viewfinder) The viewfinder contains an index mark indicating the UP direction of the bending section. 4. Diopter adjustment ring Adjusts the operator’s focus. This does not affect focusing for photography. 5. Suction valve (MAJ-207) This valve is depressed to activate suction, and 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. 6. Single-use biopsy valve (MAJ-210) Accessories may be inserted through the slit in this valve. A syringe may be inserted for the introduction of fluids. 7. Instrument channel This channel functions as: channel for insertion of endo-therapy accessories suction channel fluid feed channel (from a syringe via the biopsy valve) 8. 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. •
BF-XP60 (White)
•
BF-MP60, P60 (Blue)
•
BF-1T60 (Yellow)
9. Bending section This section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated.
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BF TYPE 60 Series OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
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 – 40C (50 – 104F)
Relative humidity
30 – 85%
Atmospheric pressure
700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)
Standard storage Ambient temperature environment (e.g. Relative humidity within the hospital) Atmospheric pressure
5 – 40C (41 – 104F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)
Ambient temperature Transportation environment Relative humidity (conditions during Atmospheric pressure transportation and short-term storage)
–47 to 70C (–52.6 to 158F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)
BF TYPE 60 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
Specifications BF-XP60 Optical system
Insertion tube
Instrument channel
Field of view
90
Depth of field
2 – 50 mm
Distal end outer diameter
ø 2.8 mm
Insertion tube outer diameter
ø 2.8 mm
Working length
600 mm
Inner channel diameter
ø 1.2 mm
Minimum visible distance
1.5 mm
Direction from which endo-therapy accessories enter and exit the endoscopic image
Bending section
Angulation range
Total length
UP 180, DOWN 130 910 mm
BF-MP60 Optical system
Insertion tube
Instrument channel
Field of view
120
Depth of field
3 – 50 mm
Distal end outer diameter
ø 4.0 mm
Insertion tube outer diameter
ø 4.4 mm
Working length
600 mm
Inner channel diameter
ø 2.0 mm
Minimum visible distance
3 mm
Direction from which endo-therapy accessories enter and exit the endoscopic image
14
Bending section Angulation range
UP 180, DOWN 130
Total length
900 mm
BF TYPE 60 Series OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
BF-P60 Optical system
Insertion tube
Instrument channel
Field of view
120
Depth of field
3 – 50 mm
Distal end outer diameter
ø 4.9 mm
Insertion tube outer diameter
ø 5.0 mm
Working length
600 mm
Inner channel diameter
ø 2.2 mm
Minimum visible distance
5 mm
Direction from which endo-therapy accessories enter and exit the endoscopic image
Bending section
Angulation range
Total length
UP 180, DOWN 130 900 mm
BF-1T60 Optical system
Insertion tube
Instrument channel
Field of view
120
Depth of field
3 – 50 mm
Distal end outer diameter
ø 5.9 mm
Insertion tube outer diameter
ø 6.0 mm
Working length
600 mm
Inner channel diameter
ø 3.0 mm
Minimum visible distance
5 mm
Direction from which endo-therapy accessories enter and exit the endoscopic image
Bending section Angulation range
UP 180, DOWN 130
Total length
900 mm
BF TYPE 60 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
Medical Devices Directive
EMC
This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a Applied standard; IEC 60601-1-2: 2001
This instrument complies with the standards listed 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 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
2412345 The last digit of the year of manufacture is the second digit of the serial number.
Degree of protection against electric shock
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BF TYPE 60 Series OPERATION MANUAL
TYPE BF applied part
Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use the instrument and see Chapter 5, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 5, contact Olympus. Damage or irregularity may compromise user or patient safety and may result in more severe equipment damage.
•
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. Before using this instrument for the first time, reprocess it according to the instructions given in the endoscope’s companion manual, the “REPROCESSING MANUAL” which cover lists the model of your endoscope.
BF TYPE 60 Series OPERATION MANUAL
17