Cleaning and Disinfection Guide for Transducer and Ultrasound System

NOTE: Always use protective equipment such as face mask, eyewear, and gloves when cleaning and disinfecting probes.

• 1) If applicable, remove the biopsy adapter, needle guide or protective sheath from the probe.
• 2) Before conducting the HLD process, clean the probes thoroughly.

NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the probe lens.

• 3) Hold the probe and put one pump of Tristel Duo ULT in the crevices of the probe. (See Figure 1 ①)
• 4) Use a swab to spread the Tristel Duo ULT Foam in the crevices. (See Figure 1 ②)
• 5) Put two pumps of Tristel Duo ULT on a Tristel Dry Wipe and clean from housing to the lens of the probe. (See Figure 1 ③)
• 6) Use another dry swab to dry and clean the crevices. (See Figure 1 ④)
• 7) After cleaning, thoroughly dry the probe.

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.

• 1) Change your gloves.
• 2) Hold the probe and put one pump of Tristel Duo ULT in the crevices of the probe. (See Figure 2 ①)
• 3) Use a swab to spread the Tristel Duo ULT Foam in the crevices. Leave the disinfectant on the probe for at least 30 seconds. (See Figure 2 ②)
• 4) Put two pumps of Tristel Duo ULT on a Tristel Dry Wipe and disinfect the transducer from housing to the lens of the probe. Leave the disinfectant on the probe for at least 30 seconds. (See Figure 2 ③)

• 1) Leave the surface to dry, ensuring at least 30 seconds of dry time.
• 2) Use the probe immediately or store the probe properly (e.g. in a sterile bag) to prevent any further contamination.

• 1) Register the disinfection data for traceability according to local regulations.
• 2) Examine the probe and the cable for damage such as cracks, splitting, sharp edges, or projections. If such damage is found, discontinue use of the device and contact your Samsung Medison representative.

※ 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.

• 1) If applicable, remove the biopsy adapter, needle guide, or protective sheath from the probe.
• 2) Before conducting High-Level Disinfection(HLD) process, clean the probes thoroughly all cleaners and disinfections listed in the cleaning and disinfection guide are in accordance to the manufacturer's instructions.

NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the probe lens.

• 3) If necessary, follow the rinse (and neutralization) instructions from the cleaner or disinfectant manufacturer for rinsing the probe.
• 4) After cleaning, thoroughly dry the probe.

• 1) Before using the CIDEX® OPA, be sure to read the usage instructions.

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%.

• 2) Before using CIDEX® OPA every time, must be verified by CIDEX® OPA test strip to see if ortho-phthalaldehyde concentration is above 0.3% Minimum Effective Concentration(MEC).

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).

• 1) Change your gloves.
• 2) Immerse the probe into the CIDEX® OPA solution. (See Figure 4.)

NOTE: Ensure that all air bubbles are removed from the surface of the probe by agitating.

• 3) Allow the probe to soak in the CIDEX® OPA for 12 minutes.

• 1) Thoroughly rinse the probe by fully immersing it in sterile water to the point in the figure above. (See Figure 4.)
• 2) Remove all air bubbles from the surface of the probe and allow the probe to set for a minimum of 1 minute.
• 3) Repeat the Step 1) and 2) of Rinse two more times for a total of 3 rinses using a fresh batch of sterile water each time.

• 1) Remove water from all surfaces of the probe with a sterile lint-free cloth.
• 2) Use the probe immediately or store the probe properly (e.g. in a sterile bag) to prevent any further contamination.

• 1) Visibly examine the probe and cable for any potential damage such as cracks, splitting, sharp edges or projections. If any damage is observed then discontinue the use of the device and contact your local Samsung Medison representative.

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.

• 1) If applicable, remove the biopsy adapter, needle guide or protective sheath from the probe.
• 2) Before conducting the HLD process, clean the probes thoroughly with wiping or immersion method as per the instructions of the chosen detergent manufacturer.

NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the lens of the probe.

• 3) If necessary, follow the rinse (and neutralization) instructions from the cleaner or disinfectant manufacturer for rinsing the probe.
• 4) After cleaning, thoroughly dry 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.

• 1) Change your gloves.
• 2) Immerse the probe into the Metricide™ OPA Plus solution. (See Figure 4.)

NOTE: Ensure that all air bubbles are removed from the surface of the probe by agitating.

• 3) Allow the probe to soak in the Metricide™ OPA solution for 12 minutes.

• 1) Thoroughly rinse the probe by fully immersing it in pure water to the point in the figure above. (See Figure 4.)
• 2) Remove all air bubbles from the surface of the probe and allow the probe to set for a minimum of 1 minute.
• 3) Repeat the Step 1) and 2) of Rinse two more times for a total of 3 rinses using a fresh batch of pure water each time.

• 1) Remove water from all surfaces of probe with a sterile lint-free cloth.
• 2) Use the probe immediately or store the probe properly (e.g. in a sterile bag) to prevent any further contamination.

• 1) Examine the probe and cable for damage such as cracks, splitting, sharp edges, or projections. If such damage is found, discontinue use of the device and contact your Samsung Medison representative.

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.

• 1) If applicable, remove the biopsy adapter, needle guide or protective sheath from the probe.
• 2) Before conducting the HLD process, clean the probes thoroughly with wiping or immersion method as per the instructions of the chosen detergent manufacturer.

NOTE: Do not use paper or abrasive products when cleaning the probe. They can damage the lens of the probe.

• 3) If necessary, follow the rinse (and neutralization) instructions from the cleaner or disinfectant manufacturer for rinsing the probe.
• 4) After cleaning, thoroughly dry the probe.

• 1) Refer to trophon® EPR/trophon®2 Instructions for use for proper use of the device, including correct positioning of the probe.

NOTE:Incorrect positioning of the probe may result in: Unsuccessful HLD cycles. (See Figures 5, 6.)

• Residual disinfectant remaining on the probe’s surface may lead to temporary bleaching or irritation of the skin, or both, if gloves are not worn.
• Check with your Samsung Medison representative to use probes not listed in the trophon® EPR/trophon®2 Compatible Ultrasound Probe list.
• Damage to the probe may occur if in contact with the chamber wall.

• 1) Refer to trophon® EPR/trophon®2 Instructions for Use for proper use of the device, instructions on how to run a high-level disinfection cycle and removal of the probe.
• 2) Remove the probe in trophon® EPR/trophon®2 following the user instructions of trophon® EPR/trophon®2 for details of proper use.

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.)

• 1) Use a dry, sterile lint-free cloth to wipe the probe after a disinfection cycle. Visually inspect the probe and remove any present disinfectant residue.

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.

• 2) Use the probe immediately or store the probe properly (e.g. in a sterile bag) to prevent any further contamination.

• 1) Examine the probe and cable for damage such as cracks, splitting, sharp edges, or projections. If such damage is found, discontinue use of the device and contact your Samsung Medison representative.

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.

• 1) If applicable, remove the biopsy adapter, needle guide or protective sheath from the probe.
• 2) Before conducting the HLD process, clean the probes thoroughly with wiping or immersion method as per the instructions of the chosen detergent manufacturer.

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.)

• 3) If necessary, follow the rinse (and neutralization) instructions from the cleaner or disinfectant manufacturer for rinsing the probe.
• 4) After cleaning, thoroughly dry the probe.

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.

• 1) Change your gloves.
• 2) Immerse the probe into the CIDEX® OPA solution. (See Figure 7)

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.

• 3) Allow the probe to soak in the CIDEX® OPA solution for 12 minutes.

• 1) Thoroughly rinse the probe by fully immersing it in sterile water to the point in the figure above. 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.)
• 2) Remove all air bubbles from the surface of the probe and allow the probe to set for a minimum of 1 minute.
• 3) Repeat the Step 1) and 2) of Rinse two more times for a total of 3 rinses using a fresh batch of sterile water each time.

• 1) Remove water from all surfaces of the probe with a sterile lint-free cloth.
• 2) Use the probe immediately or store the probe properly (e.g. in a sterile bag) to prevent any further contamination.

• 1) Examine the probe and cable for damage such as cracks, splitting, sharp edges, or projections. If such damage is found, discontinue use of the device and contact your Samsung Medison representative.

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.

• 1) If applicable, remove the biopsy adapter, needle guide or protective sheath from the probe.
• 2) Before conducting the HLD process, clean the probes thoroughly.

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.)

• 3) Wipe the MPTEE probe with 5 Tristel Dry Wipes soaked with 8 ml 1.6% CIDEZYME and wipe for 3 minutes.
• 4) Thoroughly clean the probe with a detergent especially taking care of the junctions of the flexible part and the crevices on the transducer. (See Figure 8.)
• 5) Rinse the MPTEE probe for 1 minute with water.

Prepare a gigasept® PAA concentrate with a concentration of at least 2% using the manufacturer’s instructions.

• 1) Change your gloves.
• 2) Place the MPTEE probe in the 2% gigasept® PAA concentrate. (See Figure 9)

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.)

• 3) Ensure that all air is removed from the surface of the MPTEE probe.
• 4) Leave the MPTEE probe for 15 minutes in the solution.

NOTE: gigasept® PAA working solution shall not be used more than 12 hours and/or have visible contamination.

• 1) Remove the MPTEE probe from the solution and thoroughly rinse all surfaces up to the immersion point. (See Figure 9.)
• 2) Rinse two more times with sterile water for a minimum of 1 minute each time.

• 1) Thoroughly dry all surfaces of the probe using a sterile, lint-free wipe or cloth, changing wipes/ cloths when necessary to ensure the probe is completely dry. Visually inspect the probe to ensure all surfaces are clean and dry. Repeat the drying steps if any moisture is still visible.
• 2) Use the probe immediately or store the probe properly (e.g. in a sterile bag) to prevent any further contamination.

• 1) Examine the probe and cable for damage such as cracks, splitting, sharp edges, or projections. If such damage is found, discontinue use of the device and contact your Samsung Medison representative.

NOTE: Register the disinfection data according to local regulations for traceability.

• Use a compatible wipe or cleaner for Pre-cleaning before using the disinfection equipment.
• Use the ‘protect cover’ while cleaning to protect transducer from shock.
• After disinfection, keep transducer in the designated holder with sterilized vinyl or protective cover.

• Cause : Using a towel or excessive force to clean the lens surface
• Recommended : Use a soft, lint-free wipe. (If Lens abrasion occurs, please stop using transducer immediately.)

• Causes : Use of Non-recommended disinfectant/towel, Poor cleaning of disinfectant/gel residues
• Recommendation : Please use a wet wipe or soft tissue to remove disinfectant and gel, and be sure to dry thoroughly after cleaning.

• Causes : Disinfectant permeation and lens discoloration by using dis-recommended disinfectant.
• Recommendation : Use recommended disinfectant listed on web site and use transducer cover to prevent permeation.

• Causes : Transducer damage caused by falling or shock.
• Recommendation : When storing probes, store them in the probe holder designated for their type.

• Causes : dents by sharp tool(Gel outlet, sharp equipment). (Lens area)
• Recommendation : Avoid direct contact with the lens and gel caps, and follow proper application guidelines when using the biopsy.

• Causes : Excessive bending of cable, Cable pressed on system wheel, Mis-mount of Switch box.
• Recommendation : Move the system after separating transducer, and check horizontal mount when installing transducer.

• Mount the probe so that it is not in contact with the wall of the chamber
• Mount the probe so that its tip is above the designated line in the chamber.
  Be careful not to hit the probe when closing the door.
• Make sure that the mounting position of the probe allows the strain relief to be mounted on the Gland seal.

• Do not let the probe to be too close to the inside wall of the chamber, as this can cause damage to the probe, make sure that the probe does not touch the chamber walls and floor. (No contact)
• Because the Endo cavity Probe is longer than the other probes, you must be especially careful to keep it away from UV light sources.
• If abnormally high temperature of UV-C lamp in the chamber is detected, stop using the sterilizer immediately and have it checked.