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INSTRUCTIONS ULTRASONIC PROBE
UM-S20-17S
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 and storage ...
4
Spare equipment ...
4
Repair and modification ...
4
Signal words...
5
Precautions ...
5
Chapter 1
Checking the Package Contents...
8
Chapter 2
Instrument Nomenclature and Specifications ...
9
2.1
Ultrasonic probe...
9
2.2
Specifications...
11
Preparation and Inspection ...
13
3.1
Preparation of the equipment...
14
3.2
Reprocessing equipment ...
14
3.3
Inspection...
15
3.4
Removal of air bubbles ...
16
3.5
Inspection of the endoscopic system ...
17
Operation ...
20
4.1
Insertion ...
21
4.2
Observation of the ultrasound image ...
24
4.3
Withdrawal ...
25
4.4
End of operation...
26
Reprocessing: General Policy...
27
5.1
Instructions...
27
5.2
Importance reprocessing ...
28
5.3
Precautions ...
29
5.4
Reprocessing before the first use/reprocessing and storage after use 31
Chapter 3
Chapter 4
Chapter 5
Chapter 6
Compatible Reprocessing Methods and Chemical
ULTRASONIC PROBE UM-S20-17S
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Contents
Agents ...32 6.1
Compatibility summary...
32
6.2
List of the compatible methods ...
32
6.3
Detergent solution for manual cleaning...
35
6.4
Disinfectant solution for manual disinfection or Sterilant Solution...
36
6.5
Water ...
37
6.6
Rinsing water ...
37
6.7
Alcohol ...
37
6.8
ETD (Endo Thermo Disinfectors) ...
38
6.9
OER-AW (Olympus Endoscope Reprocessor) ...
39
6.10 Ethylene oxide gas sterilization...
40
6.11 Steam sterilization (autoclaving) of accessories ...
42
6.12 Signs of degradation from reprocessing and its number of times ...
43
Chapter 7 7.1
Summary of reprocessing workflow ...
46
7.2
Workflow for reprocessing ultrasonic probes and accessories ...
47
Chapter 8
Cleaning, Disinfection, and Sterilization Procedures 48
8.1
Required reprocessing equipment ...
48
8.2
Manually Cleaning the Ultrasonic Probe ...
49
8.3
Manually Disinfecting the Ultrasonic Probe...
52
8.4
Sterilization ...
54
8.5
Cleaning, disinfection, and sterilization procedures for accessories and reprocessing equipment... 55
Chapter 9
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Reprocessing Workflow for Ultrasonic Probes and Accessories ...46
Reprocessing Ultrasonic Probes and Accessories Using an AER/WD ...62
9.1
Reprocessing probes and accessories using an AER ...
62
9.2
Reprocessing probes and accessories using an ETD ...
62
9.3
Reprocessing probes and accessories using an OER-AW...
63
9.4
Reprocessing accessories using a WD...
63
Chapter 10 Storage and Disposal ...
65
10.1 Inspection before storage ...
65
10.2 Storage ...
66
10.3 Disposal ...
66
Chapter 11 Troubleshooting ...
67
11.1 Troubleshooting guide ...
68
ULTRASONIC PROBE UM-S20-17S
Contents
Appendix A: System Chart ...
69
Appendix B: Inspection of the probe after cleaning, disinfection or sterilization in accordance with IEC 60601-2-37 ... 71 Appendix C: Acoustic Output...
72
Acoustic output table ...
72
Accuracy of measurement ...
75
Appendix D: EMC Information...
76
ULTRASONIC PROBE UM-S20-17S
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Contents
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ULTRASONIC PROBE UM-S20-17S
Symbols
Symbols The meaning(s) of the symbol(s) shown on the component packaging the back cover of this instruction manual and/or this instrument are as follows: Refer to instructions. Caution TYPE BF applied part Serial number IPX7
Ingress protection rating (except for connectors) Ultrasonic probe Manufacturer
Authorized representative in the European Community
Translation
Importer (into European Union)
Date of manufacture
ULTRASONIC PROBE UM-S20-17S
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Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use This instrument has been designed for use with in combination with Olympus endoscopic ultrasound system for intraluminal sonographic imaging of gastrointestinal tract wall; biliary (common bile, cystic, intrahepatic); pancreatic ducts; surrounding organs and upper airways and tracheobronchial tree. 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 healthcare facilities administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (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 any 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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ULTRASONIC PROBE UM-S20-17S
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 that 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 does not explain or discuss clinical endoscopic procedures.
Instrument compatibility Refer to the “Appendix A: System Chart” to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage. This instrument complies with the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable.
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Important Information - Please Read Before Use
Reprocessing and storage The ultrasonic probe (UM-S20-17S) and the probe holder (MH-245) were not disinfected or sterilized before shipment. Before using the instruments for the first time, reprocess them according to the instructions in Chapter 8, “Cleaning, Disinfection, and Sterilization Procedures”. After using the instruments, reprocess and store them according to the instructions in Chapter 5, “Reprocessing: General Policy” and Chapter 10, “Storage and Disposal”. 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.
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 11, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 11, contact Olympus.
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ULTRASONIC PROBE UM-S20-17S
Important Information - Please Read Before Use
Signal words The following 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.
Precautions 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 apply the instrument to the heart. This could result in patient fatality.
•
Always wear appropriate personal protective equipment. Patient debris adhering to the ultrasonic probe could pose an infection-control risk.
•
This device is not intended for fetal use.
•
After using this instrument, reprocess and store it according to the instructions given in Chapters 5 through 8. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.
•
Do not hit, stretch, twist, drop, or bend excessively the distal end, insertion section, or connector section of the ultrasonic probe. Otherwise, the equipment may be damaged, causing an injury in the body cavity, burns, bleeding, perforation, or detachment of parts.
•
Never insert or withdraw the insertion tube abruptly or with excessive force. Patient injury, bleeding, and/or perforation can result.
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Important Information - Please Read Before Use
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•
If it is difficult to insert the probe, do not forcibly insert the probe; stop the endoscopy. Forcible insertion can result in patient injury, bleeding, and/or perforation.
•
Do not use the MAJ-643R balloon sheath in combination with this instrument. The balloon can be destroyed, debris may get into the body cavity, and the instrument may be damaged or be difficult to withdraw from the patient.
•
If any irregularity in the ultrasound image is observed, turn the ultrasound center OFF immediately. Continued ultrasound radiation will cause the distal end to become hot and could cause operator and/or patient burns.
•
Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.
•
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.
•
To prevent unnecessary patient exposure to ultrasonic waves follow the “as-low-as-reasonably-achievable” (ALARA) principle when using Olympus ultrasound equipment. Freeze the image whenever you are not actively viewing the “live” ultrasound image. When the equipment is in the FREEZE mode, no ultrasound energy is emitted into the patient.
•
Do not coil the insertion tube with a diameter of less than 20 cm. equipment damage can result.
•
Do not use the MH-246R balloon sheath in combination with this instrument. This could damage this instrument.
•
Do not apply shock to the distal end of the insertion tube.
•
Do not hold the ultrasonic transducer when holding the insertion tube. The ultrasonic transducer damage can result and/or the ultrasound image will be abnormal.
•
Do not touch the electrical contacts in the connector pipe.
ULTRASONIC PROBE UM-S20-17S
Important Information - Please Read Before Use
•
Turn the endoscopic ultrasound center OFF before connecting or disconnecting the ultrasonic connector. If the connector is connected or disconnected while the power is ON, equipment damage can result.
•
The ultrasonic connector of the probe is not waterproof. Before immersing the instrument, always attach the water-resistant cap.
•
Interference of ultrasonic signal may occur on this ultrasonic probe when this ultrasonic probe was operated with other ultrasonic instruments, such as ultrasonic endoscope or other ultrasonic probe. It might result in the abnormal ultrasound image of this ultrasonic probe and/or other ultrasonic instruments. If ultrasonic signal interference occurs, mitigation measures may be necessary, such as relocating the scan plane of the instruments, or freeze the ultrasound image to stop the emission of the ultrasound energy.
•
To check the electromagnetic influence from other equipment (any equipment other than this instrument or the components that constitute this system), the system should be observed to verify its normal operation in the configuration in that it will be used.
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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 in Chapter 8, “Cleaning, Disinfection, and Sterilization Procedures”.
8
Probe holder (MH-245)
Water-resistant cap (MH-244)
Ultrasonic probe (UM-S20-17S)
Instruction manual
ULTRASONIC PROBE UM-S20-17S
Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Ultrasonic probe 9. Probe holder (MH-245)
13. Ring 10. Indication color of instrument channel 11. Contact pin
12. Water-resistant cap (MH-244) 1. Connector pipe
8. Insertion tube
2. Connector section Ultrasonic probe
3. Probe holder mounting section 4. Ultrasonic transducer
7. Ultrasonic propagation fluid medium
6. Housing
ULTRASONIC PROBE UM-S20-17S
5. Flexible shaft
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Chapter 2 Instrument Nomenclature and Specifications
1. Connector pipe Connects to the probe driving unit. 2. Connector section Hold this part when inserting the probe driving unit. 3. Probe holder mounting section Attach the probe holder here. 4. Ultrasonic transducer Emits and collects the ultrasonic waves. 5. Flexible shaft Transmits rotational motion from the probe driving unit to the housing. 6. Housing Contains the ultrasonic transducer. 7. Ultrasonic propagation fluid medium Propagates the ultrasonic waves. 8. Insertion tube The insertion tube is inserted into the patient’s body through the endoscope instrument channel. 9. Probe holder (MH-245) Temporarily holds the probe’s insertion tube. 10. Indication color of instrument channel The color indicates the minimum instrument channel diameter required for the endoscope to be compatible. 11. Contact pin Position the contact pin upward before inserting the probe driving unit. 12. Water-resistant cap (MH-244) Always attach the cap to the probe’s connection section when the probe is cleaned and disinfected. 13. Ring The instrument has to be stored hanging. Therefore, place the ring of water-resistant cap onto a hook.
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ULTRASONIC PROBE UM-S20-17S
Chapter 2 Instrument Nomenclature and Specifications
2.2
Specifications The compatible Olympus endoscopes are listed in the “Appendix A: System Chart”. New endoscopes released after the introduction of this instrument may also be compatible with this instrument. For further details, contact Olympus.
Use this instrument only in combination with products recommended by Olympus. If combined with products not recommended by Olympus, patient or operator injury, malfunction, or equipment damage may result.
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)
Transportation and storage environment
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 Ultrasonic functions Display mode
B-mode
Scanning method
Mechanical, radial scanning, 360
Scanning direction
Perpendicular to the direction of insertion
Frequency
20 MHz
Contact method
Direct contact method. Sterile deaerated water immersion method.
ULTRASONIC PROBE UM-S20-17S
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Chapter 2 Instrument Nomenclature and Specifications
General safety standard for medical electrical equipment
IEC 60601-1: 2005
Medical Devices Directive
EMC
This instrument, in part or in whole, may come in contact with its operators or patients. This device complies with the requirements of directive 93/42/EEC concerning medical devices. Classification: Class II a
Applied standards; IEC 60601-1-2: 2001 IEC 60601-1-2: 2007 IEC 60601-1-2: 2014 IEC 60601-2-37: 2007
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 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable.
Year of manufacture
1012345 The last digit of the year of manufacture is given in the second digit of the serial number.
Degree of protection against electric shock Ingress protection rating
TYPE BF applied part
IPX7
This instrument complies with the standards for medical electrical equipment: IEC 60601-1:2005 IEC 60601-2-37:2007.
Size Working length (mm)
2150
Total length (mm)
2225
Insertion tube outer diameter (mm)
ø 1.4 (Distal end side 1085 mm) ø 1.7 (Proximal side)
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ULTRASONIC PROBE UM-S20-17S
Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection •
Before each use prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as instructed in its respective instruction manuals. If any irregularities are observed, do not use the instrument and see Chapter 11, “Troubleshooting”. If the irregularity is still observed after consulting Chapter 11, contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.
•
The ultrasonic probe (UM-S20-17S) and the probe holder (MH-245) were not disinfected or sterilized before shipment. Before using the instruments for the first time, reprocess them according to the instructions in Chapter 8, “Cleaning, Disinfection, and Sterilization Procedures”.
•
Do not use the MAJ-643R balloon sheath in combination with this instrument. The balloon may be destroyed, debris may get into the body cavity, and the instrument may be damaged or be difficult to withdraw from the patient.
•
Do not use the water supply unit for procedures that require a sterilized ultrasonic probe. Doing so poses an infection-control risk.
•
Do not coil the insertion tube with a diameter of less than 20 cm. Doing so could damage the insertion tube.
•
Do not use the MH-246R balloon sheath in combination with this instrument. Doing so could damage this instrument.
•
Do not use an endoscope with a channel diameter below 1.5 mm with this instrument. Otherwise, this instrument may be damaged.
ULTRASONIC PROBE UM-S20-17S
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Chapter 3 Preparation and Inspection
3.1
Preparation of the equipment Prepare the equipment shown in Figure 3.1 (for compatibility, see the “Appendix A: System Chart”) 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.
Video monitor Ultrasonic probe Probe driving unit Video system center
Water container
Light source Endoscopic ultrasound center
Suction pump
Water supply unit (for ultrasonic endoscope)
• Paper towels
• Trays
Endoscope
• Lint-free cloths
• Personal protective equipment
Figure 3.1
3.2
Reprocessing equipment Prepare the required reprocessing equipment as described in Section 8.1, “Required reprocessing equipment” on page 48 for immediate reprocessing after use.
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ULTRASONIC PROBE UM-S20-17S
Chapter 3 Preparation and Inspection
3.3
Inspection •
Be sure to wear sterilized gloves before inspecting the ultrasonic probe. Otherwise, the probe will be contaminated and may pose an infection-control risk.
•
Be careful not to contaminate the ultrasonic probe when using it for procedures that require a sterilized ultrasonic probe. Doing so may pose an infection-control risk.
•
If any irregularity is observed with the ultrasonic probe as a result of the following inspection, do not use it and contact Olympus. Using an abnormal ultrasonic probe may result in infections, incidents such as malfunction in the middle of the examination, equipment damage, or degradation of performance.
•
Ultrasonic propagation fluid is sealed within the ultrasonic probe. Depending on the storage conditions, air bubbles can gather in the ultrasonic propagation fluid medium around the ultrasonic transducer. Before use, always inspect the ultrasonic probe for air bubbles according to the following procedures. If the area around the ultrasonic transducer is devoid of propagation fluid medium and air bubbles have gathered, remove the air bubbles as described in Section 3.4, “Removal of air bubbles” on page 16. Air bubbles around the ultrasonic transducer will compromise the quality of the ultrasound image.
1. Prepare and inspect the ultrasonic probe as described Chapter 8, “Cleaning, Disinfection, and Sterilization Procedures”.
2. Carefully run your fingertips over the entire length of the insertion tube.
Inspect for any protrusions, bends, leakage of ultrasonic propagation fluid medium, or other irregularities.
3. Make sure that the connector pipe is dry and free of debris. 4. Carefully inspect the transparent sheath of the ultrasonic probe’s insertion tube to confirm that there are no air bubbles present around the ultrasonic transducer (see Figure 3.2).
5. If air bubbles are present, remove the air bubbles according to the following procedures.
ULTRASONIC PROBE UM-S20-17S
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