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INSTRUCTIONS
ULTRASONIC PROBE
UM-S20-20R
CAUTION : Balloons Used with This Product Contain Natural Rubber Latex, Which May Cause Allergic Reactions.
Contents
Contents Symbols...
1
Important Information - Please Read Before Use...
2
Intended Use ...
2
Applicability of endoscopy ...
2
Instruction Manual ...
2
User Qualifications ...
3
Instrument Compatibility ...
3
Reprocessing and Storage ...
3
Repair and Modification ...
3
Signal Words...
4
Precautions ...
4
Chapter 1
Checking the Package Contents...
6
Checking the Package Contents...
6
Instrument Nomenclature and Specifications ...
8
2.1
Ultrasonic Probe ...
8
2.2
Specifications...
10
Preparation and Inspection ...
13
3.1
Preparation of the Equipment ...
13
3.2
Inspection...
16
3.3
Removal of Air Bubbles ...
17
3.4
Inspection of the Endoscopic System ...
18
Operation ...
21
4.1
Insertion of the Ultrasonic Probe Through an Endoscope ...
22
4.2
Insertion When Using the Sterile, De-aerated Water Immersion Method ...
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4.3
Insertion When Using Balloon Method...
25
4.4
Percutaneous Probe Insertion ...
25
4.5
Observation...
25
4.6
Withdrawing From the Endoscope...
26
Reprocessing...
27
5.1
General Policy...
27
5.2
Precautions ...
28
1.1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
ULTRASONIC PROBE UM-S20-20R
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Contents
Chapter 6 6.1
Compatibility summary...
31
6.2
List of the compatible methods ...
31
6.3
Detergent solution for manual cleaning...
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6.4
Disinfectant solution for manual disinfection or Sterilant Solution...
35
6.5
Water ...
35
6.6
Rinsing water ...
36
6.7
ETD (Endo Thermo Disinfectors) ...
37
6.8
OER-AW (Olympus Endoscope Reprocessor) ...
38
6.9
Ethylene oxide gas sterilization...
39
6.10 Steam sterilization (autoclaving) of accessories ...
41
6.11 Signs of degradation from reprocessing and its number of times ...
43
Chapter 7
Reprocessing Workflow for Ultrasonic Probes and Accessories... 45
7.1
Summary of reprocessing workflow ...
45
7.2
Workflow for reprocessing ultrasonic probes and accessories ...
45
Cleaning, Disinfection, and Sterilization Procedures ...
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8.1
Compatible Reprocessing Methods and Chemical Agents ...
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8.2
Required Reprocessing Equipment ...
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8.3
Manually Cleaning the Ultrasonic Probe ...
50
8.4
Manually Disinfecting the Ultrasonic Probe...
53
8.5
Sterilization ...
54
8.6
Cleaning, Disinfection and Sterilization Procedures for Removable Parts ...
56
Maintaining of the Probe Driving Unit...
62
Chapter 8
8.7
Chapter 9
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Compatible Reprocessing Methods and Chemical Agents... 31
Reprocessing Ultrasonic Probes and Accessories Using an AER ... 63
9.1
Reprocessing probes and accessories using an AER ...
63
9.2
Reprocessing probes and accessories using an ETD ...
63
9.3
Reprocessing probes and accessories using an OER-AW...
64
9.4
Reprocessing accessories using a WD...
65
Chapter 10 Storage and Disposal ...
66
10.1 Inspection Before Storage ...
66
10.2 Storage ...
67
10.3 Disposal ...
67
ULTRASONIC PROBE UM-S20-20R
Contents
Chapter 11 Troubleshooting ...
68
11.1 Troubleshooting Guide...
68
11.2 Returning the Probe Driving Unit for Repair ...
69
Appendix A: System Chart ...
70
Appendix B: Inspection of the probe after cleaning, disinfection or sterilization in accordance with IEC 60601-2-37 ...
72
Appendix C: Acoustic Output Table ...
73
Appendix D: EMC information...
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ULTRASONIC PROBE UM-S20-20R
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Contents
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ULTRASONIC PROBE UM-S20-20R
Symbols
Symbols The meaning(s) of the symbol(s) shown on the package, 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-S20-20R
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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 Endoscopic Ultrasound Center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract and surrounding organs, the upper airways and tracheobronchial tree, and the urinary organs. Do not use this instrument for any purpose other than its intended use.
Applicability of endoscopy lf there is an official standard on the applicability of endoscopy that is defined by the healthcare facilities administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy, thoroughly evaluate its properties, purposes, effects, and possible risks (their natures, extent, and probability). Perform endoscopy only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy as well as any examination methods that can be performed in its place, and perform the endoscopy only after obtaining the consent of the patient. Even after starting the endoscopy, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy 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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ULTRASONIC PROBE UM-S20-20R
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. It only describes basic operation and precautions related to the operation of this endoscope.
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.
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”. After using this instrument, reprocess and store it according to the instructions in Chapter 5, “Reprocessing” and Chapter 6, “Compatible Reprocessing Methods and Chemical Agents”. 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 11, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 11, contact Olympus.
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Important Information - Please Read Before Use
Signal Words The following words are used throughout this manual.
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
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.
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•
Never apply the instrument to the heart. This could results in fatal accidents.
•
Always wear appropriate personal protective equipment. Patient debris adhering to the ultrasonic probe could present an infection control risk.
•
This device is not intended for fetal use.
•
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.
ULTRASONIC PROBE UM-S20-20R
Important Information - Please Read Before Use
•
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 ultrasound radiation, 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 ultrasonic 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 apply shock to the distal end of the Insertion Tube.
•
Do not touch the electric contacts in the Ultrasonic Connector of the Probe Driving Unit.
•
Turn the Endoscopic Ultrasound Center’s power switch OFF before connecting or disconnecting the Ultrasonic Connector. If the connector is connected or disconnected while the Endoscopic Ultrasound Center power is ON, equipment damage can result.
•
Do not pull, twist or tightly coil the Ultrasonic Cable. Noise can develop in the ultrasonic image.
•
The Ultrasonic Connector of the probe is not waterproof. Before immersing the instrument, always attach the Water-resistant Cap.
In case of any serious incident happens to User or Patient while operating the device, the incident should be reported to Olympus and the competent authority of the respective member state or country.
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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”.
Probe Holder (MH-245)
Instruction Manual
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Water-resistant Cap (MH-244)
Ultrasonic Probe (UM-S20-20R)
ULTRASONIC PROBE UM-S20-20R
Chapter 1 Checking the Package Contents
ULTRASONIC PROBE UM-S20-20R
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Ultrasonic Probe
13. Probe Holder (MH-245)
12. Ring 9. Indication Color of Instrument Channel 10. Contact Pin
11. 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
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6. Housing
ULTRASONIC PROBE UM-S20-20R
5. Flexible Shaft
Chapter 2 Instrument Nomenclature and Specifications
1. Connector Pipe Connects to the Probe Driving Unit. 2. Connector Section Hold this part when insert the Probe Driving Unit. 3. Probe Holder Mounting Section Attach the Probe Holder here. 4. Ultrasonic Transducer Emits and picks up 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 Fluid to propagate the ultrasonic waves. 8. Insertion Tube Into the body through the endoscope instrument channel. 9. Indication Color of Instrument Channel The color indicates the minimum instrument channel diameter required for the endoscope to be compatible. 10. Contact Pin Contact pin upward, insert the Probe Driving Unit. 11. Water-resistant Cap (MH-244) Always attach the cap to the probe’s Connection Section when the Probe is cleaned and disinfected. 12. Ring Suspend the instrument by hanging the ring of Water-resistant Cap onto a hook. 13. Probe Holder (MH-245) Temporarily holds the Probe’s Insertion Tube.
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Specifications The compatible Olympus endoscopes are listed in the following compatibility table. New endoscopes released after the introduction of this instrument may also be compatible for use in combination 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 – 40°C (50 – 104°F)
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 70°C (–52.6 to 158°F)
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
Scanning Direction
Perpendicular to the direction of insertion
Frequency
20 MHz
Contact Method
Direct contact method. Sterile De-aerated water immersion method. Balloon Method (Balloon sheath (MH-246R) is necessary).
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ULTRASONIC PROBE UM-S20-20R
Chapter 2 Instrument Nomenclature and Specifications
General safety standard for medical electrical equipment
IEC 60601-1: 2005
Medical Devices Directive
0197 EMC
Applied standards; IEC 60601-1-2: 2001 IEC 60601-1-2: 2007 IEC 60601-1-2: 2014 IEC 60601-2-37: 2007
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 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
H812345 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)
2050
Total Length (mm)
2140
Insertion Tube Outer Diameter (mm)
ø 1.7 (Distal end side 850 mm) ø 2.0 (Proximal side)
ULTRASONIC PROBE UM-S20-20R
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Chapter 2 Instrument Nomenclature and Specifications
Compatible Olympus Endoscope (All of these parameters should be met)
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Model and Length
Except L-length Colonoscope
Inner Channel Diameter (mm) (Color Code)
ø 2.2 (Blue) ø 2.6 (Green) ø 2.8, ø 3.2 (Yellow) ø 3.7, ø 4.2, ø 6 (Orange) ø 5.5 (Pink)
Rigid scopes
Minimum capacity is 6 Fr.
ULTRASONIC PROBE UM-S20-20R
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 respective instruction manuals. Should the slightest irregularity be suspected, do not use the instrument and see Chapter 11, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 11, 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”.
Do not coil the Insertion Tube with a diameter of less than 20 cm. This could result in damage to the Insertion Tube.
3.1
Preparation of the Equipment Equipment and Personal Protective Equipment According to the “Appendix A: System Chart” prepare this instrument, other equipment that are used with this instrument, 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 particular case. Refer to the respective instruction manual for each piece of equipment.
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Chapter 3 Preparation and Inspection
Sterile De-aerated Water Immersion Method The devices denoted by∗ are not for bronchial use. •
Olympus endoscope having a minimum channel diameter of 2.2 mm (except L-length Colonoscope); for bronchoscopes or other scopes shorter than 850 mm; ø 2.0 mm
•
Olympus Endoscopic Ultrasound Center (EU-M30)
•
Water Supply Unit (For Ultrasonic Endoscope) (UWS-1)∗
•
Probe / Irrigation Plug (MD-807)∗
Balloon Method •
Olympus endoscope having a minimum channel diameter of 3.7 mm (except L-length Colonoscope)
•
Balloon Sheath (MH-246R)
•
Olympus Endoscopic Ultrasound Center (EU-M30)
•
Water Supply Unit (For Ultrasonic Endoscope) (UWS-1) as required
Preparation and Inspection of Ancillary Equipment Prepare and inspect the endoscope, the Light Source, Ultrasound Imaging System, Display Monitor, Water Container, Suction Pump and Endo-Therapy Accessories according to their respective instruction manuals.
Spare Instrument Always have a spare instrument available.
Reprocessing Equipment Prepare the required reprocessing equipment as described in Chapter 5, “Reprocessing” for immediate reprocessing after use.
Installation of the Supporting Arm (MD-808) on the Mobile Workstation (WM-30) Never apply excessive weight to the Supporting Arm.
1. Attach the Supporting Arm Shaft (MH-709) to the Mobile Workstation as instructed in the Supporting Arm Shaft’s instruction manual (see Figure 3.1).
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ULTRASONIC PROBE UM-S20-20R
Chapter 3 Preparation and Inspection
2. Attach the Supporting Arm Shaft. Tighten the knob securely. 3. Confirm that the Stopper of the Supporting Arm is locked.
Stopper
Workstation M5 × 20 mm long screw M5 plain washer M5 shakeproof washer
Fixing Plate Supporting Arm Shaft
Figure 3.1
Installation of the Probe Driving Unit (MH-240) 1. Remove the Bolt from the Driver Section Adapter on the Probe Driving Unit. 2. Insert the end of the Supporting Arm into the Driver Section Adapter. 3. Align the holes on the Supporting Arm and the Driver Section Adapter and insert the Bolt (see Figure 3.2).
4. Tighten the bolt to secure the Probe Driving Unit to the Supporting Arm. Probe Driving Unit
Bolt
Supporting Arm
Driver Section Adapter
Figure 3.2 ULTRASONIC PROBE UM-S20-20R
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