URF-P5 Instructions Feb 2007
104 Pages
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INSTRUCTIONS
OES URETERO-RENO FIBERSCOPE
OLYMPUS URF TYPE P5
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 ...
3
Maintenance management...
4
Prohibition of improper repair and modification ...
4
Signal words ...
4
Warnings and cautions...
5
Examples of inappropriate handling ...
7
Chapter 1
Checking the Package Contents...
8
Chapter 2
Instrument Nomenclature and Specifications ...
9
2.1
Nomenclature...
9
2.2
Endoscope functions...
10
2.3
Specifications...
11
Preparation and Inspection ...
13
3.1
Preparation of the equipment...
14
3.2
Preparation and inspection of the endoscope...
15
3.3
Preparation and inspection of accessories ...
17
3.4
Attaching accessories to the endoscope ...
17
3.5
Preparation, inspection and connection of ancillary equipment...
18
3.6
Inspection of the endoscopic system ...
21
Operation ...
23
4.1
Insertion ...
25
4.2
Using endo-therapy accessories...
30
4.3
Using laser system...
32
4.4
Withdrawal of the endoscope...
33
Chapter 3
Chapter 4
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Contents
Chapter 5
Reprocessing: General Policy...
34
5.1
Importance of cleaning, disinfection and sterilization...
34
5.2
Precautions ...
35
Chapter 6 6.1
Compatibility summary...
38
6.2
Detergent solution ...
43
6.3
Ultrasonic cleaning...
44
6.4
Disinfectant solution ...
45
6.5
Rinsing water ...
46
6.6
Automatic cleaning/disinfection...
46
6.7
Ethylene oxide gas sterilization...
47
6.8
Steam sterilization (autoclaving) of accessories ...
49
Chapter 7
Cleaning, Disinfection and Sterilization Procedures ... 52
7.1
Required reprocessing equipment ...
53
7.2
Cleaning, disinfection and sterilization procedures ...
60
7.3
Precleaning ...
61
7.4
Transportation of the endoscope ...
63
7.5
Leakage testing...
65
7.6
Manual cleaning ...
69
7.7
High-level disinfection ...
76
7.8
Rinsing and drying after high-level disinfection...
78
7.9
Automatic cleaning/disinfection...
80
7.10 Sterilization ...
80
Chapter 8
Maintenance Procedures of Reprocessing Equipment ...
82
Storage, Transporting Outside the Hospital and Disposal...
83
9.1
Storage of the endoscope ...
83
9.2
Storage of reusable parts and reprocessing equipment ...
84
9.3
Transporting outside the hospital ...
84
9.4
Disposal ...
85
Chapter 10 Troubleshooting ...
86
10.1 Troubleshooting guide ...
87
10.2 Withdrawal of the endoscope with an abnormality...
89
10.3 Returning the endoscope for repair...
89
Chapter 9
ii
Compatible Reprocessing Methods and Chemical Agents... 38
OES URETERO-RENO FIBERSCOPE URF-P5
Contents
Appendix ...
91
System chart ...
91
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Contents
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OES URETERO-RENO FIBERSCOPE URF-P5
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
Manufacturer
Authorized representative in the European Community
Lot number
Serial number
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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, video monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney. Do not use this instrument 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 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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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 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.
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 in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”. After using the instrument, reprocess and store it according to the instructions 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.
Spare equipment Be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.
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Important Information - Please Read Before Use
Maintenance management The probability of failure of the endoscope and ancillary equipment increases as 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 87. 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.
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.
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Important Information - Please Read Before Use
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.
•
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 light guide cable during an examination. The light guide will be pulled out from the output socket of the light source and the endoscopic image will not be visible.
•
Only use Olympus light guide cables (WA03200A, WA03202A, A03200A, A3090, A3091, A3093, A3290, A3291, A3293) with this endoscope. Other light guide cables could cause the control section of the endoscope to overheat, which could cause operator and/or patient burns.
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Important Information - Please Read Before Use
•
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 and the light guide connector immediately after removing the light guide from the endoscope and light source because they are extremely hot.
•
Never insert or withdraw the insertion tube abruptly or with excessive force. Patient injury, bleeding and/or perforation can result.
OES URETERO-RENO FIBERSCOPE URF-P5
Important Information - Please Read Before Use
•
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 portion.
•
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.
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. •
Inserting and using endo-therapy accessories without a clear endoscopic view may cause patient injury, burns, bleeding and/or perforation.
•
Patient injury may be caused by: inserting or withdrawing the endoscope without a clear endoscopic view; forcefully pulling, twisting or rotating the angulated bending section.
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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 before shipment. Before using this instrument for the first time, reprocess the endoscope and all ancillary equipment according to the instructions in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.
Endoscope (URF-P5)
Forceps/irrigation plug (isolated type) (MAJ-891)
Suction connector cleaning brush (BW-15SH)
Biopsy valve (MAJ-579) (10 pcs)
Channel-opening cleaning brush (MH-507)
Channel cleaning brush (BW-7B)1
Instruction manual
Single Use Single-ended Cleaning Brush (BW-400B)1
Instruction manual (Forceps/irrigation plug (isolated type))
1 These products may not be available in some areas.
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ETO cap (MB-156)
OES URETERO-RENO FIBERSCOPE URF-P5
Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature 6. Light guide adapter
3. Eyepiece frame (viewfinder) Eyepiece section
4. Diopter adjustment ring
13. Identification mark for STERRAD® 200/NX material compatibility
2. UP/DOWN angulation control lever
5. Light guide connector Serial number
1. UP/DOWN angulation lock
8. Instrument channel
Forceps port
Control section
Irrigation port
7. Forceps/irrigation plug (MAJ-891)
Instrument channel port 9. Color code (white) Boot
Objective lens
10. Venting connector
Light guide lens
Insertion tube/working length Instrument channel Distal end (enlarged) 12. ETO cap (MB-156)
Distal end 11. Bending section
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions 1. UP/DOWN angulation lock Turning this lever in the “F ” direction frees angulation. Turning the lever in the opposite direction locks the bending section at any desired position. 2. UP/DOWN angulation control lever When turned in the “U” direction, the bending section moves UP; when turned in the “D” direction, the bending section moves DOWN. 3. Eyepiece frame (viewfinder) The viewfinder mask has an index mark indicating the UP direction of the bending section. 4. Diopter adjustment ring Turn the ring to adjust the focus. For photography, set the ring to the ‘click stop’ position before mounting the camera. 5. Light guide connector Connects the endoscope to the light source using the light guide cable (WA03200A, WA03202A, A03200A). Transfers light from the light source to the distal end of the endoscope. 6. Light guide adapter Connects the light guide connector and the light guide cable (A3090, A3091, A3093, A3290, A3291, A3293). The light guide adapter is detached from the light guide connector before shipment. If necessary, connect it to the light guide connector. 7. Forceps/irrigation plug (MAJ-891) Accessories are inserted through the forceps port. Fluid can be fed through the irrigation port. 8. Instrument channel The instrument channel functions as: channel for insertion of endo-therapy accessories; irrigation channel. 9. Color code Indicates the compatibility of endo-therapy accessories. The endoscope can be used with endo-therapy accessories that have the same color code. •
White: URF-P5
10. Venting connector Attach the ETO cap or leakage tester here. 11. Bending section Moves the distal end of the endoscope by operating the UP/DOWN angulation control lever.
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Chapter 2 Instrument Nomenclature and Specifications
12. ETO cap (MB-156) The ETO cap is equalizing the outer and inner pressure. The ETO cap must be attached prior to gas sterilization (ethylene oxide gas, STERRAD® 50/100 etc.) and aeration and must be 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.). 13. 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)
Transportation Ambient temperature 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)
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Chapter 2 Instrument Nomenclature and Specifications
Specifications Endoscope Model Optical system
URF-P5 90
Field of view
0 (forward viewing)
Direction of view Depth of field Insertion portion
2 mm – 50 mm
Distal end outer diameter
5.3 Fr (bullet shape)
Insertion tube outer diameter
ø 2.8 mm (8.4 Fr)
Working length Instrument channel
700 mm
Inner channel diameter
ø 1.2 mm (3.6 Fr)
Compatible Olympus endo-therapy accessories
Endo-therapy accessories for ø 1.2 mm (3.6 Fr) channel
Minimum visible distance
1.5 mm
Direction from which endo-therapy accessories enter and exit the endoscopic image
Bending section
UP 180, DOWN 275
Angulation range
Total length
1050 mm
Degree of protection against electric shock Year of manufacture
TYPE BF applied part 2612345 The last digit of the year of manufacture is the second digit of the serial number.
Medical Devices Directive
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This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a
OES URETERO-RENO FIBERSCOPE URF-P5
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. If any irregularities are suspected after inspection, follow the instructions given in Chapter 10, “Troubleshooting”. 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 89.
•
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”.
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Chapter 3 Preparation and Inspection
3.1
Preparation of the equipment Prepare the instrument, shown in Figure 3.1 (for compatibility, see the “System chart” in the Appendix) and personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves, before each use. Refer to the respective instruction manuals for each piece of equipment.
Endo-therapy accessories
Forceps/irrigation plug (isolated type) (MAJ-891)
Guidewire
Endoscope
Ureteroscope sheath dilator (ST-U1)
Light source • Paper towels
• Trays
Light guide cable • Lint-free cloths
• Personal protective equipment
Figure 3.1
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Chapter 3 Preparation and Inspection
3.2
Preparation and inspection of the endoscope Clean and disinfect or sterilize the endoscope as described in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.
Inspection of the Endoscope 1. Inspect the control section and the light guide connector for excessive scratching, deformation, loose parts or other irregularities.
2. Inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.
3. Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, bends, adhesion of foreign bodies, dropout of parts, any protruding objects or other irregularities.
4. While holding the insertion tube gently with one hand, carefully run your fingertips of the other hand over the entire length of the insertion tube in both directions (see Figure 3.2). Confirm that there is no object stopping the hand or protruding objects or other irregularities.
Figure 3.2
5. Inspect the covering of the bending section for sagging, swelling, cuts, holes or other irregularities.
6. Gently hold the midpoint of the bending section and a point 10 cm from the distal end. Push and pull gently to confirm that the border between the bending section and the distal end is not loose.
7. Inspect the objective lens at the distal end of the endoscope for dents, bulges, swelling or other irregularities. OES URETERO-RENO FIBERSCOPE URF-P5
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