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INSTRUCTIONS
RHINO-LARYNGOFIBERSCOPE
OLYMPUS ENF TYPE GP
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents
Contents Symbols...
1
Important Information - Please Read Before Use...
2
Intended use ...
2
Instruction manual ...
2
User qualifications ...
2
Instrument compatibility ...
2
Reprocessing and storage ...
3
Repair and modification ...
3
Signal words ...
3
Warnings and cautions...
4
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...
10
Preparation and Inspection ...
12
3.1
Preparation of the equipment...
13
3.2
Preparation and inspection of the endoscope...
14
3.3
Preparation and inspection of accessories ...
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3.4
Attaching accessories to the endoscope ...
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3.5
Preparation, inspection and connection of ancillary equipment...
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3.6
Inspection of the endoscopic system ...
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Operation ...
20
4.1
Insertion ...
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4.2
Withdrawal of the endoscope...
24
4.3
Transportation of the endoscope ...
24
Reprocessing: General Policy...
26
5.1
Instructions...
26
5.2
Precautions ...
27
Chapter 3
Chapter 4
Chapter 5
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Contents
Chapter 6 6.1
Compatibility summary...
29
6.2
Detergent solution ...
30
6.3
Disinfectant solution ...
31
6.4
Rinsing water ...
31
6.5
ETO gas sterilization ...
32
6.6
Steam sterilization (autoclaving) of accessories ...
34
Chapter 7
ii
Compatible Reprocessing Methods and Chemical Agents... 29
Cleaning, Disinfection and Sterilization Procedures ... 36
7.1
Required reprocessing equipment ...
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7.2
Cleaning, disinfection and sterilization procedures ...
38
7.3
Precleaning ...
39
7.4
Leakage testing...
40
7.5
Manual cleaning ...
42
7.6
High-level disinfection ...
44
7.7
Rinsing after high-level disinfection...
45
7.8
Sterilization ...
46
7.9
Cleaning, disinfection and sterilization procedures for reusable parts ... 47
Chapter 8
Cleaning and Disinfection Equipment ...
51
Chapter 9
Storage ...
52
Chapter 10 Troubleshooting ...
53
10.1 Troubleshooting guide ...
53
10.2 Returning the endoscope for repair...
54
Appendix...
55
System chart ...
55
RHINO-LARYNGOFIBERSCOPE ENF-GP
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
For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf
RHINO-LARYNGOFIBERSCOPE ENF-GP
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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, display monitor and other ancillary equipment for endoscopic diagnosis within the nasal and nasopharyngeal lumen. Do not use this instrument for any purposes other than their intended uses.
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.
User qualifications The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures.
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.
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RHINO-LARYNGOFIBERSCOPE ENF-GP
Important Information - Please Read Before Use
Reprocessing and storage 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 Chapter 5, “Reprocessing: General Policy” through Chapter 8, “Cleaning and Disinfection Equipment”. After using this instrument, reprocess and store it according to the instructions given in Chapter 5 through Chapter 9. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.
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. Some problems that appear to be malfunctions may be correctable by referring to Chapter 10, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 10, contact Olympus.
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.
4
•
Never operate the bending section, perform suction, insert or withdraw the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.
•
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 into all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient. Otherwise, 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, 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.
RHINO-LARYNGOFIBERSCOPE ENF-GP
Important Information - Please Read Before Use
•
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.
•
Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation and treatment, it may also cause alteration of living tissues such as protein denaturation of liver tissue and perforation of the intestines by inappropriate using. Observe the following warnings on the illumination. Always set the minimum required brightness. The brightness of the image on a video monitor may differ from actual brightness at the distal end of endoscope. Especially, operating the electrical shutter function of a video system, pay attention to the brightness level setting of the light source. When a light source and a video system are compatible with the automatic brightness control function, be sure to use the function of the light source. The automatic brightness control function can keep the illumination light properly. Refer to the instruction manual of the light source and the video system for details. Do not continue observation in proximity to tissue or keep the distal end of the endoscope in contact with a living tissue for a long time. When discontinuing the use of the endoscope, be sure to turn the light source OFF or activate the light shield function (standby mode etc.) so that the endoscope does not irradiate unnecessary light.
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Important Information - Please Read Before Use
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•
If the endoscopic image dims during use, this may be a sign that blood or mucus is adhered to the light guide on the distal end of endoscope. Carefully withdraw the endoscope from patient and remove the blood or mucus in order to obtain optimum illumination and to ensure the safety of examination. If you continue to use the endoscope in such a condition, the distal end temperature may rise and cause mucosa burns. It may also cause patient and/or operator injury.
•
Be sure to prepare another endoscope to avoid that the examination be interrupted due to equipment failure or malfunction.
•
Do not coil the insertion tube with a diameter of less than 10 cm. Equipment damage can result.
•
Do not strike the distal end of the insertion tube or allow it to strike other objects. The objective lens surface of the distal end is particularly fragile, and vision 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 bending section’s covering may stretch or break and cause water leaks.
•
The eyepiece section cannot be removed. Do not attempt to rotate it by force.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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. •
Using improperly reprocessed or stored instruments may cause patient cross-contamination and/or infection.
•
Applying prolonged suction with the distal end in contact with the mucosal surface may cause bleeding or suction lesions.
•
Patient injury may be caused by inserting or withdrawing the endoscope without a clear endoscopic image withdrawing the endoscope with the angulation controls locked 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 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 8, “Cleaning and Disinfection Equipment”.
Endoscope
ETO cap (MB-156)
8
Light guide adapter (MAJ-900)
RHINO-LARYNGOFIBERSCOPE ENF-GP
Instruction manual
Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature
Eyepiece section 3. Eyepiece frame (viewfinder) 4. Diopter adjustment ring
Light guide
2. UP/DOWN angulation control lever
Serial number Control section
ETO cap (MB-156) Venting connector Boot Insertion tube/working length 1. Bending section Distal end
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions 1. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated. 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 contains an index mark indicating the UP direction of the bending section. 4. Diopter adjustment ring The diopter adjustment ring adjusts the operator’s focus. This does not affect focusing for photography.
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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RHINO-LARYNGOFIBERSCOPE ENF-GP
Chapter 2 Instrument Nomenclature and Specifications
Specifications Optical system
Insertion tube
Bending section
Field of view
85
Depth of field
5 – 50 mm
Distal end outer diameter
ø 3.4 mm
Insertion tube outer diameter
ø 3.6 mm
Working length
300 mm
Angulation range
UP 130, DOWN 130
Total length
550 mm
Medical Devices Directive
Year of manufacture
This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a 71012345 The year of manufacture is given in the second digit of the serial number.
Degree of protection against electric
TYPE BF applied part
shock
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Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection
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•
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 this instrument and see Chapter 10, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 10, contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.
•
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 Chapter 5, “Reprocessing: General Policy” through Chapter 8, “Cleaning and Disinfection Equipment”.
RHINO-LARYNGOFIBERSCOPE ENF-GP
Chapter 3 Preparation and Inspection
3.1
Preparation of the equipment Prepare the equipment shown in Figure 3.1 (for compatibility, see the “System chart” in the Appendix) and personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves, before each use. Refer to the respective instruction manual for each piece of equipment.
Endoscope
Light source
• Paper towels
Light guide adapter
• Trays
• Personal protective equipment
Light guide cable
• Lint-free cloth
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 8, “Cleaning and Disinfection Equipment”.
Inspection of the endoscope 1. Inspect the control section for excessive scratching. 2. Inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.
3. Inspect the surface of the insertion tube for dents, bulges, swelling, peeling or other irregularities.
4. Carefully run your fingertips over the entire length of the insertion tube. Inspect for any protruding objects or other irregularities (see Figure 3.2).
Figure 3.2
5. Inspect the bending section’s covering for sagging, swelling, cuts, holes or other irregularities.
6. Gently hold the midpoint of the bending section and a point 5 cm from the distal end. Push and pull gently to confirm that there is no play.
7. Inspect the objective lens at the distal end of the endoscope’s insertion tube for scratching, cracks, stains, gaps around the lens or other irregularities.
8. Confirm that the diopter adjustment ring turns smoothly and that the eyepiece section is attached securely to the control section. Confirm that the eyepiece is free of defects, such as scratches or deformations.
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RHINO-LARYNGOFIBERSCOPE ENF-GP
Chapter 3 Preparation and Inspection
When cleaning or wiping the eyepiece lens surface, do not use abrasive cleansers because they may scratch the lens surface.
9. Wipe the eyepiece section and light guide using a clean, lint-free cloth moistened with 70% ethyl or isopropyl alcohol.
Inspection of the bending mechanism Perform the following inspections while the bending section is straight.
Inspection of operation
1. Move the UP/DOWN angulation control lever slowly in each direction until it stops. Confirm that the bending section moves smoothly and correctly and that maximum angulation can be achieved.
2. Move the UP/DOWN angulation control lever slowly to its neutral position. Confirm that the bending section returns smoothly to an approximately straight condition.
3.3
Preparation and inspection of accessories Prepare the light guide adapter.
Inspection of the light guide adapter Inspect the light guide adapter (MAJ-900) for damage.
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Chapter 3 Preparation and Inspection
3.4
Attaching accessories to the endoscope Attaching the light guide adapter 1. Attach the light guide adapter to the light guide fitting on the endoscope (see Figure 3.3).
2. Rotate the light guide adapter clockwise until it stops. Light guide Light guide adapter
Figure 3.3
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RHINO-LARYNGOFIBERSCOPE ENF-GP
Chapter 3 Preparation and Inspection
3.5
Preparation, inspection and connection of ancillary equipment Preparation and inspection of ancillary equipment Prepare and inspect the light source according to its instruction manual.
Connection of the endoscope and ancillary equipment •
Only use Olympus light guide cables A3093/A3293/WA03200A with this endoscope. If another light guide cable is used, the control section of the endoscope may become too hot and cause operator and/or patient burns.
•
The distal end of the endoscope may exceed 41C (106F) and reach 50C (122F) due to intense endoscopic illumination. Surface temperatures over 41C (106F) may cause mucosal burns. Always use the minimum level of illumination necessary for adequate viewing. Whenever possible, avoid close stationary viewing and do not leave the distal end of the endoscope close to mucous membranes for a long time.
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