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INSTRUCTIONS
OES HYSTEROFIBERSCOPE
OLYMPUS HYF TYPE XP
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 ...
3
User Qualifications ...
4
Instrument Compatibility ...
4
Reprocessing and Storage ...
4
Repair and Modification ...
4
Signal Words...
5
Warnings and Cautions ...
5
Chapter 1
Checking the Package Contents...
8
Checking the Package Contents...
8
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, Inspection and Connection of the Ancillary Equipment
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3.4
Inspection of the Endoscopic System ...
20
Operation ...
21
4.1
Insertion ...
23
4.2
Withdrawal of the Endoscope ...
26
4.3
Transportation of the Endoscope...
26
Reprocessing: General Policy...
28
5.1
Instructions...
28
5.2
Precautions ...
29
1.1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
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Contents
Chapter 6
Compatible Reprocessing Methods and Chemical Agents...
32
6.1
Compatibility Summary ...
32
6.2
Detergent Solution ...
33
6.3
Disinfectant Solution ...
33
6.4
Rinsing Water ...
34
6.5
ETO Gas Sterilization...
34
6.6
Steam Sterilization (Autoclaving) of Accessories...
37
Chapter 7 7.1
Required Reprocessing Equipment ...
39
7.2
Cleaning, Disinfection and Sterilization Procedures ...
45
7.3
Precleaning ...
46
7.4
Leakage Testing ...
48
7.5
Manual Cleaning ...
50
7.6
High Level Disinfection...
55
7.7
Rinsing After High Level Disinfection ...
57
7.8
Sterilization ...
59
7.9
Cleaning, Disinfection and Sterilization Procedures for Cleaning Equipment...
59
Storage ...
64
Storage ...
64
Troubleshooting ...
65
9.1
Troubleshooting Guide...
65
9.2
Returning the Endoscope for Repair...
66
Appendix...
67
System Chart ...
67
Chapter 8 8.1
Chapter 9
ii
Cleaning, Disinfection and Sterilization Procedures ... 38
OES HYSTEROFIBERSCOPE HYF-XP
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
OES HYSTEROFIBERSCOPE HYF-XP
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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 TV Camera System, Light Source and TV Monitor for endoscopic diagnosis within the uterus. Do not use this instrument for any purpose other than its intended use.
Indications and Contraindications for use Indications and contraindications for flexible hysteroscopy include the following:
Indications for use
2
•
Abnormal Uterine Bleeding
•
Amenorrhea
•
Evaluation of Abnormal Hysterosalpingogram
•
Infertility and Pregnancy Wastage
•
Pelvic Pain
OES HYSTEROFIBERSCOPE HYF-XP
Important Information - Please Read Before Use
Contraindications for use (Absolute and Relative) Absolute The only currently accepted absolute contraindication to hysteroscopy is acute PID. Relative Relative contraindications include • Inability to distend the uterus • Cervical/vaginal infection • Uterine bleeding or menses • Known pregnancy • Invasive carcinoma of the cervix • Recent uterine perforation • Medical contraindication or intolerance of anesthesia The choice of location of hysteroscopy, e.g. office setting vs. hospital, may be altered by medical disease cervical stenosis, and pelvic infection.
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 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 Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage.
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 in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”. After using this 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.
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. Problems that appear not to be malfunctions may be correctable by referring to Chapter 9, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 9, contact Olympus.
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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 described below when handling this instrument. This information is supplemented by the warnings and cautions described in each chapter.
•
Never insert or withdraw the endoscope’s Insertion Tube while the UP/DOWN angulation is locked. Patient injury or equipment damage can result.
•
Never perform angulation control, insert/withdraw the endoscope without viewing the endoscopic image. Patient injury can result.
•
Do not touch the metal plug of the Light Guide Connector immediately after removing it from the Light Source because it is extremely hot.
•
Never use high-frequency Endo-Therapy Accessories because the Distal End of this instrument is not insulated. Using high-frequency accessories places the patient at risk of electrical shock.
•
This instrument is not intended for use laser or electrosurgical devices.
•
Suspicion of pregnancy should suggest a pregnancy test prior to the performance of diagnostic hysteroscopy.
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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 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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•
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.
•
Prolonged excessive flow rates and/or pressures of irrigation fluid/gas may result in excessive absorption into the vascular system (e.g., through an open vessel) or gas embolism.
OES HYSTEROFIBERSCOPE HYF-XP
Important Information - Please Read Before Use
•
While in use, do not pull of the Universal Cord. The Light Guide 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 and the Universal Cord with a diameter 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 of the Distal End. Visual abnormalities may result.
•
Do not twist or bend the Bending Section. Equipment damage may result.
•
Do not squeeze the Bending Section forcefully. The covering of the Bending Section may stretch or break causing water leaks.
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 infection.
•
Inserting without a clear endoscopic view may cause patient injury.
•
Patient injury may be caused by; Inserting or withdrawing the endoscope without a clear endoscopic view; withdrawing the endoscope with the angulation controls locked; or forcefully bending and pulling, twisting or rotating the endoscope’s tip.
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Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package Contents 1.1
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 in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.
Endoscope
Channel Cleaning Brush (BW-7B)1
Channel-opening Cleaning Brush (MH-507)
Single Use Single-ended Cleaning Brush (BW-400B)1
ETO Cap (MB-156)
Channel Cleaning Brush (BW-15SH)
Instruction Manual
1 These products may not be available in some areas.
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OES HYSTEROFIBERSCOPE HYF-XP
Chapter 1 Checking the Package Contents
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature Endoscope
Universal Cord
1. Eyepiece Frame (Viewfinder)
5. Channel Port
2. Diopter Adjustment Ring
4. UP/DOWN Angulation Lock
3. UP/DOWN Angulation Control Lever Eyepiece Section Control Section
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OES HYSTEROFIBERSCOPE HYF-XP
Boot
Chapter 2 Instrument Nomenclature and Specifications
9. ETO Cap
7. Venting Connector
Serial Number
6. Light Guide Connector
Distal End Insertion Tube
8. Bending Section
Channel
Insertion Portion (Working Length) Light Guide Lens
Distal End (Enlarged)
OES HYSTEROFIBERSCOPE HYF-XP
Objective Lens
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope Functions 1. Eyepiece Frame (Viewfinder) The viewfinder mask is seen with an index mark indicating the UP direction of the Bending Section. 2. Diopter Adjustment Ring Turn the ring to adjust focus to the operator’s diopter. For photography, set the ring to the click stop position before mounting the camera. 3. 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. 4. 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. 5. Channel Port Functions as: irrigation channel. 6. Light Guide Connector Connects to the Light Source. Transfers light from the Light Source to the operative site. 7. Venting Connector Accepts ETO Cap or Leakage Tester. 8. Bending Section Moves the Distal End of the endoscope by operating the UP/DOWN Angulation Control Lever. 9. ETO Cap The ETO Cap must be installed 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 HYSTEROFIBERSCOPE HYF-XP
Chapter 2 Instrument Nomenclature and Specifications
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 Functions Optical System
Insertion Portion
Field of View
100
Direction of View
0 Forward Viewing
Depth of Field
2 – 50 mm
Distal End Outer Diameter ø 3 mm Insertion Tube Outer Diameter
ø 3.1 mm
Working Length
240 mm
Channel
Channel Inner Diameter
ø 1.2 mm
Bending Section
Angulation Range
UP 100 DOWN 100
Total Length
540 mm
Medical Devices Directive
This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a
Year of manufacture
1712345 The last digit of the year of manufacture is given in the second digit of the serial number.
Degree of protection against electric shock
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OES HYSTEROFIBERSCOPE HYF-XP
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 used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use the instrument, see Chapter 9, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 9, 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 in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.
OES HYSTEROFIBERSCOPE HYF-XP
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Chapter 3 Preparation and Inspection
3.1
Preparation of the Equipment According to the “System Chart” in Appendix, prepare this instrument, other equipment that are used with this instrument, distension system, paper towels, basin, lint-free cloth and personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves, for the procedure. Refer to the respective instruction manual for each piece of equipment.
Endoscope
Light Source
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OES HYSTEROFIBERSCOPE HYF-XP
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 Light Guide Connector for excessive scratching.
2. Inspect the Boot and the Insertion Tube near the Boot for bends and twists or other irregularities.
3. Inspect the surface of the Insertion Tube for dents, bulges 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 3.1).
Figure 3.1
5. Inspect the covering of the Bending Section for sagging, swelling, cuts, holes or other irregularities.
6. Gently grasp the middle of the Bending Section with one hand and with the other hand grasp the Bending Section approximately 5 cm from the Distal End. Push and pull Bending Section gently to confirm that there is no play.
7. Inspect the Objective Lens and Light Guide Lens at the Distal End of the endoscope 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 securely attached to the Control Section. Confirm that the Eyepiece Section is free of defects, such as scratches or deformations.
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