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최적의 환경에서
삼성헬스케어닷컴을 만나보세요
현재 접속하신 브라우저는 지원하지 않습니다.
삼성헬스케어닷컴의 원활한 사용을 위해서는 아래 브라우저 사용을 권장합니다.
브라우저가 설치되어 있지 않은 경우 아이콘을 클릭하여 설치하실 수 있습니다.
현재 사용하시는 브라우저를 확인하려면 아래 사이트를 참고해주세요
https://whatsmybrowser.org/Selection 1 | Selection 2 | Selection 3 | Selection 4 | Selection 5 | ||
---|---|---|---|---|---|---|
Name | ||||||
Type | ||||||
Manufacture |
System | ||||||
Transducer |
Name | Type | Manufacture | Selection 1 | Selection 2 | Selection 3 | Selection 4 | Selection 5 | ||
The following disinfectant matrix indicates which disinfectants are compatible with specific system areas.
Please be cautious to avoid damage by only using approved disinfectants on areas listed.
CAUTION
NOTE
Rev.30
MI68-02691V_h
All probes must be cleaned and disinfected after each use. Cleaning is an important procedure that must be carried out before disinfecting the probe. For information on cleaning and probe disinfection, please refer to ‘Cleaning, Disinfecting, and Sterilizing the Probe’ in the ‘Probes’ chapter of the user manual. Using an inappropriate disinfectant may damage the probe.
WARNING
Ultrasound probes are classified into Critical, Semi-critical or Non-critical devices based on the standards of FDA guidance* and the Hygiene Requirements for the Reprocessing of Medical Devices from Germany guideline of Robert Koch Institute (RKI). Therefore, you should use the cleaning, disinfection, and sterilization methods appropriate for each classification. Proper maintenance is also required to maintain the performance of ultrasound probes.
Classification Criteria | Contact Area | Application Probe | Level Selection |
---|---|---|---|
Non-critical devices | Intact skin | Curved, Linear, and Phased array probes | Low level disinfection |
Semi-critical devices | Mucous membrane, damaged skin | Endocavity, MPTEE | High level disinfection or sterilization |
Critical devices | Blood, sterile tissue, etc. | Intraoperative | Sterilization |
* Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Appendix E
* The FDA reprocessing guidance ‘Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff’ March 17, 2015, (https://www.fda.gov/media/80265/download)
The care method for your probes determines the appropriate disinfectant to use for your probe. An appropriate detergent, disinfectant or ultrasound gel should be used for all probes. For details about compatible detergent, disinfectants, and ultrasound gel, please see ‘Disinfectants Matrix’ on Samsung Medison website and the User Guide.
※ All disinfection methods for Semi-critical probes that are marked with ◆ in the attached Excel file have been validated by Samsung Medison for biological effectiveness.
- User Guide: This is provided as a booklet upon purchase of the product.
- Disinfectants_Matrix List: Please refer to the attached Excel file.
NOTE
Rev.30
MI68-02691V_h
For successful acoustic signal transmission, ultrasound gels or couplant must be applied.
WARNING
Oil-based lotion type couplants.
Mineral oil
Olive oil
Lubricant oil
Paraffin-based grease
Dimethylsilicone
Alcohol such as methanol, Ethanol or ethanol, or isopropanol
Acetone
Dioctylphtalate
Aromatic substances
Iodine compounds
Aloe Vera
CAUTION
Rev.30
MI68-02691V_h
NOTE: Always use protective equipment such as face mask, eyewear, and gloves when cleaning and disinfecting probes.
NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the probe lens.
Follow Tristel Duo ULT manufacturer’s instructions for preparation, temperature, solution strength, and duration of contact. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. Be sure to observe the solution expiration date.
※ Regulation and restriction of Semi-critical probe wipe type disinfection may differ per country. Please check local regulations before using wipe disinfection on Semi-critical probe.
NOTE: Always use protective equipment such as face mask, eyewear, and gloves when cleaning, and disinfecting probes.
NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the probe lens.
NOTE: The shelf life of an unopened bottle of CIDEX® OPA is two years. The CIDEX® OPA requires NO activation.
NOTE: In accordance to the CIDEX® OPA Manufacturer's usage instructions, Prepare the use CIDEX® OPA with a concentration of at least 0.55%.
NOTE: CIDEX® OPA must be discarded after 14 days, even if the CIDEX® OPA test strip indicates a concentration above the Minimum Effective Concentration(MEC).
NOTE: Ensure that all air bubbles are removed from the surface of the probe by agitating.
NOTE: Register the disinfection data according to local regulations for traceability.
NOTE: Always use protective equipment such as face mask, eyewear, and gloves when cleaning and disinfecting probes.
NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the lens of the probe.
Follow Metricide™ OPA Plus manufacturer's instructions for preparation, temperature, solution strength, and duration of contact. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. Be sure to observe the solution expiration date.
NOTE: Ensure that all air bubbles are removed from the surface of the probe by agitating.
NOTE: Register the disinfection data according to local regulations for traceability.
NOTE: Always use protective equipment such as face mask, eyewear, and gloves when cleaning and disinfecting probes.
NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the lens of the probe.
NOTE:Incorrect positioning of the probe may result in: Unsuccessful HLD cycles. (See Figures 5, 6.)
NOTE: After HLD cycle completion, wear a new set of clean gloves and it is recommended to remove the probe as soon as possible.
(The chamber may have surface temperatures up to 60°C. Care should be taken not to touch the chamber.)
NOTE: Aggressive wiping or scrubbing can damage the probe. Use a gentle wiping motion for the probe lens, the strain relief, and the areas surrounding the strain relief.
NOTE: When wiping the probe, hold the housing. Do not suspend the probe by the cable. This can damage the probes.
NOTE: Register the disinfection data according to local regulations for traceability.
NOTE: Always use protective equipment such as face mask, eyewear, and gloves when cleaning and disinfecting probes.
NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the lens of the probe.
NOTE: Immerse only the portion of the probe between the tip at the end of the probe and the area marked as 100cm. (See Figure 7.)
Follow the CIDEX® OPA manufacturer's instructions for preparation, temperature, solution strength, and duration of contact. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. Be sure to observe the solution expiration date.
NOTE: Immerse only the portion of the probe between the tip at the end of the probe and the area marked as 100cm.
NOTE: Ensure that all air bubbles are removed from the surface of the probe by agitating.
NOTE: Do not allow sharp objects to touch the lens. Do not touch the lens unnecessarily. This can damage the lens.
NOTE: Register the disinfection data according to local regulations for traceability.
NOTE: Always use protective equipment such as face mask, eyewear, and gloves when cleaning and disinfecting probes.
NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the lens of the probe.
NOTE: Immerse only the portion of the probe between the tip at the end of the probe and the area marked as 100cm. (See Figure 8.)
Prepare a gigasept® PAA concentrate with a concentration of at least 2% using the manufacturer’s instructions.
NOTE: Immerse only the portion of the probe between the tip at the end of the probe and the area marked as 100cm. (See Figure 9.)
NOTE: gigasept® PAA working solution shall not be used more than 12 hours and/or have visible contamination.
NOTE: Register the disinfection data according to local regulations for traceability.
Rev.30
MI68-02691V_h
부적절한 Cleaning은 Probe의 손상을 일으킬 수 있습니다.
Trophon에 부적절한 장착은 Probe의 손상을 일으킬 수 있습니다.
UV-C에 Probe 장착 시 부적절한 위치는 Probe 손상을 일으킬 수 있습니다.
높은 온도는 Probe 손상을 일으킬 수 있습니다.