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INSTRUCTIONS
ULTRASONIC PROBE
RU-75M-R1 RU-12M-R1
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...
3
Intended use ...
3
Applicability of endoscopy ...
3
Instruction manual ...
3
User qualifications...
4
Instrument compatibility ...
4
Reprocessing and storage ...
4
Repair and modification ...
4
Signal words...
5
Warnings and cautions ...
5
Natural rubber latex medical alert ...
7
Chapter 1
Checking the Package Contents...
8
Standard components...
8
Instrument Nomenclature and Specifications ...
10
2.1
Nomenclature and functions ...
10
2.2
Specifications...
12
Preparation and Inspection ...
15
3.1
Preparation of the equipment...
15
3.2
Inspection of the ultrasonic probe ...
18
3.3
Inspection of the endoscopic system ...
19
3.4
Preparation and inspection of the balloon...
21
Operation ...
25
4.1
Observation of the ultrasonic image ...
26
4.2
Withdrawal of the ultrasonic probe...
28
Reprocessing...
29
5.1
General policy ...
29
5.2
Precautions ...
30
5.3
Compatible reprocessing methods and chemical agents ...
32
5.4
Required reprocessing equipment ...
37
5.5
Cleaning...
40
5.6
High-level disinfection ...
44
5.7
Sterilization ...
47
1.1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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Contents
5.8
Cleaning, disinfection and sterilization procedures for removable parts51
5.9
Maintenance of the probe driving unit ...
55
Storage and Disposal ...
56
6.1
Storage ...
56
6.2
Disposal ...
56
Troubleshooting ...
57
7.1
Troubleshooting guide ...
57
7.2
Returning the probe and/or probe driving unit for repair ...
58
Appendix A: System chart ...
59
Chapter 6
Chapter 7
Appendix B: Inspection of the probe after cleaning, disinfection or sterilization in accordance with IEC 60601-2-37 ... 61
ii
Appendix C: Acoustic output table ...
62
Appendix D: EMC information ...
65
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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 endoscope
Ultrasonic probe
Single use only
Do not resterilize
Use by (expiration date)
Sterilized using ethylene oxide
Sterilization lot number
Lot number
Non-sterile
Keep away from sunlight
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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Symbols
Keep dry
Do not use if package is damaged
Contains or Presence of Natural Rubber Latex
Date of manufacture
Manufacturer
Authorized representative in the European Community
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ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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 and probe driving unit for intraluminal ultrasonic imaging of the anus, rectum and surrounding 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 hospital’s 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.
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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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 “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. Do not use this instrument with a rectoscope (romanoscope) or an anoscope. Instrument damage can result. 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 the equipment according to the instructions given in Chapter 5, “Reprocessing”. After using this instrument, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing” and Chapter 6, “Storage and Disposal”. 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 to be malfunctions may be correctable by referring to Chapter 7, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 7, contact Olympus.
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ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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.
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.
•
Never apply the instrument to the heart. This could results in fatal accidents.
•
Never use high frequency endo-therapy accessories because the distal end of this instrument is not isolated. Using high-frequency accessories places the patient at risk of electrical shock.
•
Failure to properly clean and high-level disinfect or sterilize this instrument after each examination can compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each examination the instrument must undergo thorough manual cleaning followed by high-level disinfection or sterilization.
•
Always wear appropriate personal protective equipment. Patient debris adhering to the ultrasonic probe could present an infection control risk.
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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Important Information - Please Read Before Use
6
•
Carefully insert or withdraw the ultrasonic probe using slow, short strokes. Abrupt insertion or withdrawal can cause patient injury and/or damage the probe.
•
The balloons are disposable, and are intended for a single use only. A new one must be used for each patient. Do not attempt to reuse or re-sterilize a balloon.
•
This device is not intended for fetal use.
•
Do not insert endo-therapy accessories into the channel. This could result patient injury and/or damage the probe.
•
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.
•
Do not coil the sheath section with a diameter of less than 20 cm. Equipment damage can result.
•
Do not drop this instrument or apply shock to the instrument. Doing so may cause equipment damage. Especially do not apply shock and/or excessive force to the distal end of the insertion section. If you find any cracks or other irregularities on the distal end, do not use this probe, and contact Olympus.
•
Do not touch the electric contacts in the ultrasonic connector of the probe driving unit. Doing so may cause equipment damage.
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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 endoscopic ultrasound center is ON, equipment damage can result.
•
Do not pull, twist or tightly coil the sheath section. Otherwise, noise can develop in the ultrasonic image.
•
The connector section of the probe is not waterproof. Before immersing the instrument, always attach the water-resistant cap (MH-244).
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.
Natural rubber latex medical alert Balloons used with this instrument contain natural rubber latex which may cause allergic reactions. Do not use the balloon on a latex-sensitive patient. Instead, perform the procedure using “The sterile de-aerated water immersion method” described in Section 4.1, “Observation of the ultrasonic image”. Do not use a probe cover which contains natural rubber latex on a latex-sensitive patient. For more information on this latex alert, refer to the FDA’s March 29, 1991 bulletin, “Allergic reactions to latex containing medical devices”.
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Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package Contents 1.1
Standard components 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”.
Ultrasonic probe (RU-75M-R1/RU-12M-R1)
Balloon 3 (MAJ-233, sterile, 20 pcs)
Water-resistant cap (MH-244)
Balloon applicator (MAJ-864)
Single use combination cleaning brush (BW-411B, 3 pcs) Instruction manual
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ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
Chapter 1 Checking the Package Contents
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature and functions Ultrasonic probe RU-75M-R1/RU-12M-R1 (non-sterile, reusable) 1. Connector pipe
5. Channel opening
3. Contact pin 6. Grip section 7. Insertion section
2. Connector section 4. Sheath section
10. Water-resistant cap (MH-244)
8. Distal end
9. Ultrasonic transducer
Balloon attachment groove
Distal end cap Water supply port
Balloon attachment groove
Detail of distal end
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ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
Chapter 2 Instrument Nomenclature and Specifications
1. Connector pipe This pipe connects to the probe driving unit. 2. Connector section Hold this part when connecting the ultrasonic probe to the probe driving unit. 3. Contact pin Insert the probe driving unit with this pin facing upward. 4. Sheath section This section contains a flexible shaft that transmits rotational motion from the probe driving unit to the ultrasonic transducer. 5. Channel opening This opening functions as de-aerated water feed channel. 6. Grip section Hold this section to bring the insertion section to a target. 7. Insertion section Insert this section with calibration to the anus or recum. 8. Distal end This end contains the ultrasonic transducer. 9. Ultrasonic transducer This transducer emits and receives up the ultrasonic waves. 10. Water-resistant cap (MH-244) Always attach the cap to the probe’s connector section to protect the connector from water penetration during reprocessing.
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Specifications 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
Transportation and storage 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)
Ambient temperature
–47 to 70°C (–52.6 to 158°F)
Relative humidity
10 – 95%
Atmospheric
700 – 1060 hPa
pressure
(0.7 – 1.1 kgf/cm²) (10.2 – 15.4 psia)
Specifications Ultrasonic functions
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Display mode
B-mode
Scanning method
Mechanical, radial scanning
Scanning direction
Perpendicular to the direction of insertion
Frequency
RU-75M-R1: 7.5 MHz RU-12M-R1: 12 MHz
Focus point
RU-75M-R1: 30 mm RU-12M-R1: 25 mm
Scanning range
360°
Contact method
Balloon method Sterile de-aerated water immersion method Probe-cover method
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
Chapter 2 Instrument Nomenclature and Specifications
•
The balloon method is one of the acoustic coupling methods inflating the balloon attached to the distal end and contacting the balloon to target site.
•
The probe cover method is one of the acoustic coupling methods covering the insertion section of the probe with a probe cover and contacting the distal end to target site.
•
The sterile de-aerated water immesion method is one of the acoustic coupling methods supplying de-aerated water into body cavity and obtaining ultrasonic image of target site with immersing the distal end of the probe into the water.
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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
2012345 The year of manufacture is 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
14
Maximum diameter of distal end cap
ø 11.8 mm
Maximum diameter of insertion section
ø 12 mm
Length of insertion section
150 mm
Total length
1.8 m
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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 and see Chapter 7, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 7, contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.
•
When inspecting this instrument, always wear sterile gloves. Inspect in clean environment. Otherwise, there is a danger of infection.
•
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”.
Do not coil the sheath section into a diameter of less than 20 cm. This could result in damage to the ultrasonic probe.
3.1
Preparation of the equipment Prepare all equipment and personal protective equipment which will be used with the instrument in accordance with their respective instruction manuals. Appropriate equipment may include: syringe (approximately 30 ml), three-way stopcock, extension tube (approximately 10 cm long), sterile de-aerated water and a medical-grade, water-soluble lubricant. Appropriate personal protective equipment may include: eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves.
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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Chapter 3 Preparation and Inspection
Preparation and inspection of ancillary equipment Prepare and inspect the probe driving unit, ultrasound imaging system and display monitor according to their respective instruction manuals.
Spare instrument Always have a spare instrument available in case of a malfunction.
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).
2. Attach the supporting arm (MD-808) to the supporting arm shaft. Tighten the knob securely (see Figure 3.1).
3. Confirm that the stopper of the supporting arm is locked.
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ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
Chapter 3 Preparation and Inspection
Supporting arm (MD-808) Knob
Stopper
Mobile workstation (WM-30) M5 20 mm long screw M5 plain washer M5 shakeproof washer
Fixing plate Supporting arm shaft (MD-709)
Figure 3.1
Installation of the probe driving unit (MH-240) on the supporting arm (MD-808) 1. Remove the bolt from the driver section adapter on the probe driving unit (see Figure 3.2).
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.
4. Tighten the bolt to secure the probe driving unit to the supporting arm. Probe driving unit (MH-240)
Bolt
Supporting arm (MD-808)
Driver section adapter
Figure 3.2
ULTRASONIC PROBE RU-75M-R1/RU-12M-R1
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