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INSTRUCTIONS
OES CHOLEDOCHO FIBERSCOPE
OLYMPUS CHF TYPE P60
Contents
Contents Symbols...
1
Important Information - Please Read Before Use...
2
Intended use ...
2
Applicability of endoscopy and endoscopic treatment ...
2
Instruction manual ...
2
User qualifications ...
3
Instrument compatibility ...
3
Reprocessing before the first use/reprocessing and storage after use ...
3
Spare equipment...
4
Maintenance management ...
4
Prohibition of improper 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 ...
15
3.1
Preparation of the equipment...
16
3.2
Preparation and inspection of the endoscope...
17
3.3
Preparation and inspection of accessories ...
20
3.4
Attaching accessories to the endoscope ...
21
3.5
Inspection and connection of ancillary equipment ...
23
3.6
Inspection of the endoscopic system ...
25
Operation ...
27
4.1
Insertion ...
29
4.2
Using endo-therapy accessories...
33
4.3
Withdrawal of the endoscope...
36
4.4
Transportation of the endoscope ...
37
Chapter 3
Chapter 4
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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Contents
Chapter 5
Reprocessing: General Policy...
38
5.1
Notes for cleaning, disinfection and sterilization ...
38
5.2
Precautions ...
39
Recommended Reprocessing Methods and Chemical Agents ...
42
6.1
Compatibility summary...
42
6.2
Detergent solution ...
47
6.3
Ultrasonic cleaning...
48
6.4
Disinfectant solution ...
49
6.5
Rinsing water ...
49
6.6
Automatic cleaning/disinfection...
50
6.7
Ethylene oxide gas sterilization...
51
6.8
Steam sterilization (autoclaving) of accessories ...
53
Chapter 6
Chapter 7 7.1
Required reprocessing equipment ...
57
7.2
Cleaning, disinfection and sterilization procedures ...
65
7.3
Precleaning ...
67
7.4
Transportation of the endoscope ...
70
7.5
Leakage testing...
71
7.6
Manual cleaning ...
75
7.7
Disinfection ...
85
7.8
Rinsing and Drying after disinfection...
88
7.9
Automatic cleaning/disinfection...
90
7.10 Sterilization ...
91
Chapter 8
Maintenance Procedures of Equipment for Reprocessing ...
93
Storage, Transporting Outside the Hospital and Disposal ...
94
9.1
Storage ...
94
9.2
Transporting outside the hospital ...
95
9.3
Disposal ...
95
Chapter 10 Troubleshooting ...
96
10.1 Troubleshooting guide ...
97
10.2 Withdrawal of the endoscope with an abnormality...
100
10.3 Returning the endoscope for repair...
100
Chapter 9
ii
Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments ... 56
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
Contents
Appendix ... 101 System chart ...
101
EMC information ...
105
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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Contents
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OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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
TYPE BF applied part
Endoscope
Do not reuse.
Lot number
Manufacturer
Authorized representative in the European Community
Serial number
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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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 light source, documentation equipment, monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct. 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 of endoscopy, 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/ endoscopic treatment and take proper measures if the risks to the patient become greater than the potential benefits.
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 instruments as instructed. 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.
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OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
Important Information - Please Read Before Use
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 of 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 of 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 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.
Reprocessing before the first use/reprocessing and storage after use This instrument was not cleaned, disinfected and sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”. After using the instrument, reprocess and store it according to the instructions given in Chapter 5 through Chapter 8. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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Important Information - Please Read Before Use
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 the endoscope and ancillary equipment increase as the number of procedures performed and/or the 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 10.1, “Troubleshooting guide” on page 97. If the irregularity is still suspected after inspection, contact Olympus.
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.
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OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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.
•
After using this instrument, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 9, “Storage, Transporting Outside the Hospital and Disposal”. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.
•
Do not strike, bend, hit, pull, twist, or drop the endoscope’s distal end, insertion tube, bending section, and control section 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 control forcibly or abruptly. Never forcefully pull, twist or rotate the angulated bending section. Patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during an examination.
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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Important Information - Please Read Before Use
•
Never perform angulation control or insertion/withdrawal of the endoscope’s insertion tube without viewing the endoscopic image. Patient injury, bleeding and/or perforation can result.
•
Never insert or withdraw the endoscope’s insertion tube while the UP/DOWN angulation is locked. Patient injury and/ or equipment damage can result.
•
Do not pull the universal cord during an examination. The light guide connector will be pulled out from the output socket of the light source and the endoscopic image will not be visible.
•
Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation and treatment, it may also alter living tissues by, for example, causing protein denaturation of living tissue, or perforation of the intestines. Observe the following warnings with regard to illumination. Always set the minimum required brightness. The brightness of the image on a video monitor may differ from the actual brightness at the distal end of the endoscope. Pay attention to the brightness level setting of the light source, particularly when operating the electrical shutter function of a video system center. When using a light source and video system center that are compatible with the light source’s automatic brightness control function, make sure to use the function. The automatic brightness control function can better maintain the illumination level. Refer to the instruction manual of the light source and the video system center for further details. Do not continue observation in close proximity to tissue or keep the distal end of the endoscope in contact with living tissue for a long time. When the endoscope will not be used for a long period, be sure to turn OFF the light source or activate the light shield function (standby mode, etc.) so that the endoscope is not illuminated unnecessarily.
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•
Do not touch the metal part of the light guide 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 abruptly or with excessive force. Patient injury, bleeding and/or perforation can result.
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
Important Information - Please Read Before Use
•
Be sure to prepare another endoscope to avoid that the examination must be interrupted due to equipment failure or malfunction.
•
If the endoscopic image darkens during the procedure, it may indicate that blood or mucus is adhering to the light guide on the distal end of the endoscope. Carefully withdraw the endoscope from the patient and remove the blood or mucus in order to restore optimum illumination and to ensure the safety of examination. If you continue to use the endoscope with its light guide obstructed, the temperature at the distal end may rise and cause mucosal burns in the patient. It may also cause operator injury.
•
Never use high-frequency endo-therapy accessories because the endoscope’s distal end is not insulated. Using high-frequency accessories presents a risk of electrical shock to the patient and/or damage of the endoscope may result.
•
Do not bend the insertion tube into a diameter of less than 10 cm. This could damage the insertion tube.
•
Do not strike the distal end of the insertion tube or allow it to strike other objects. The objective lens surface at the distal end is particularly fragile, and 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.
•
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.
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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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 described below.
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•
Inserting, withdrawing and using endo-therapy accessories without a clear endoscopic image may cause patient injury, burns, bleeding and/or perforation.
•
Patient injury may be caused by forcefully pulling, twisting or rotating the angulated bending section.
•
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.
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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 cleaned, disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapters 5, “Reprocessing: General Policy” through 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”.
Endoscope
Forceps/irrigation plug (Isolated type) (MAJ-891)
Biopsy valve (MAJ-579, 10 pcs)
ETO cap (MB-156)
Suction valve (MAJ-207, 10pcs)
Channel-opening cleaning brush (MH-507)
Instruction manual
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
Suction cleaning adapter (MAJ-1077)
Channel cleaning brush (BW-15B)
Instruction manual (Forceps/irrigation plug, Isolated type)
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature
10. ETO cap Universal cord
Venting connector
Serial number
Electrical contacts
Light guide
1. Light guide connector
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OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
Chapter 2 Instrument Nomenclature and Specifications
Electrical contacts
4. Eyepiece frame (Viewfinder) 5. Diopter adjustment ring 6. Suction valve (MAJ-207)
Eyepiece section
3. UP/DOWN angulation lock
2. UP/DOWN angulation control lever
Suction cylinder
Control section 7. Forceps/irrigation plug (Isolated type) (MAJ-891)
11. Identification mark for STERRAD® 200/NX material compatibility
Instrument channel port
8. Color code
Boot Insertion tube/working length
Distal end
9. Bending section
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions 1. Light guide 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. UP/DOWN angulation lock Pushing this lever in the “F ” direction frees the angulation. Pushing the lever in the opposite direction locks the bending section at any desired position. 4. Eyepiece frame (Viewfinder) The viewfinder contains an index mark indicating the UP direction of the bending section. 5. Diopter adjustment ring Adjusts the operator’s focus. This does not affect focusing for photography. 6. Suction valve (MAJ-207) The suction valve is depressed to activate suction. The valve is also used to remove any fluid or debris adhering to the objective lens.
Do not use the suction valve (MAJ-207) for more than 6 procedures. 7. Forceps/irrigation plug (Isolated type) (MAJ-891) Accessories are inserted through the forceps port. Fluid can be fed through the irrigation port. 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. • Blue:
CHF-P60
9. Bending section This section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated. 10. ETO cap The ETO cap must be attached to the venting connector prior to ETO gas sterilization and aeration and removed prior to immersion or clinical examination. The cap must also be attached when the endoscope is transported outside the hospital (shipment, return for repairs, etc.).
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OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
Chapter 2 Instrument Nomenclature and Specifications
11. 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 environment (e.g. within the hospital)
Ambient temperature
5 – 40C (41 – 104F)
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 70C(–52.6 to 158F)
Relative humidity
10 – 95%
Atmospheric pressure
700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)
Specifications Model Optical system
CHF-P60 Field of view Direction of view
Insertion tube
120 0 (forward viewing)
Depth of field
4 – 50 mm
Distal end outer diameter
ø 4.9 mm
Insertion tube outer diameter
ø 5.2 mm
Working length
380 mm
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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Chapter 2 Instrument Nomenclature and Specifications
Instrument channel
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
UP 160, DOWN 130
Total length
670 mm
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
2001234 The last digit of the year of manufacture is given in the second digit of the serial number.
Degree of protection against electric shock
14
TYPE BF applied part
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection Before each procedure, prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals. If this instrument malfunctions, do not use it. Return it to Olympus for repair as described in Section 10.3, “Returning the endoscope for repair” on page 100. If any irregularities are suspected after inspection, follow the instructions given in Chapter 10, “Troubleshooting”.
•
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 Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”.
OES CHOLEDOCHO FIBERSCOPE CHF TYPE P60
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