Innovative Diagnostic Solutions for Hygiene & Food Safety | HygienaContact Us | HygienaTechnical Support | HygienaInnovative Diagnostic Solutions for Hygiene & Food Safety | HygienaTechnical Support | Hygiena
Instruction Manual for hygiena models including: EnSURE Touch, SystemSURE Plus, ENDOSWAB Series EndoSwab Sampling Devices, ENDOSWAB Series, EndoSwab Sampling Devices, Sampling Devices, Devices
Collecte d'échantillons | Hygiena
Oct 7, 2024 — Description and Intended Use. Hygiena EndoSwab sampling devices are used to collect samples from hard-to-reach internal channels of.
File Info : application/pdf, 3 Pages, 425.14KB
DocumentDocumentHygiena® EndoSwab Endoscope Cleaning Verification Swab--For use with UltraSnap® or SuperSnap® ATP Tests Product No. ENDOSWAB-1mm, ENDOSWAB-2mm, ENDOSWAB-3mm, ENDOSWAB-4mm (100 tests) Introduction Description and Intended Use Hygiena® EndoSwab sampling devices are used to collect samples from hard-to-reach internal channels of reusable medical instruments like endoscopes to verify thorough cleaning. EndoSwab is designed to be used in conjunction with UltraSnap® or SuperSnap® ATP test devices and EnSURE® Touch or SystemSURE Plus® luminometers. This system measures adenosine triphosphate (ATP), the universal energy molecule found in all animal, plant, bacterial, yeast and mold cells. Blood and other biohazard waste contain large amounts of ATP. When ATP is brought into contact with the unique liquid-stable luciferase/luciferin reagent in the ATP test device, light is emitted in direct proportion to the amount of ATP present. Hygiena luminometers measure the amount of light generated in Relative Light Units (RLUs). The result provides information on the level of ATP left behind after cleaning to ensure cleaning procedures are effective. After cleaning, all sources of ATP should be significantly reduced. Required Materials (Not Included) · ATP test device (UltraSnap, Product No. US2020, or SuperSnap, Product No. SUS3000) · Hygiena luminometer (EnSURE Touch, Product no. ETOUCH, or SystemSURE Plus, Product no. SS3H) · Sterile scissors Recommended (Not Included) · ATP Positive Control Kit for ATP Test Devices (Product No. CK25) · CalCheck LED Calibration Verification Device (Product No. CAL) · SureTrend® Platform for data management and analysis (learn more at www.hygiena.com/analytics) Test Procedure Wear sterile gloves when collecting samples. Use aseptic technique. 1. Remove EndoSwab from packaging. Feed EndoSwab through the scope channel, leaving sufficient slack to grip the tail end of the wand. 2. Withdraw EndoSwab completely from the scope. Place the foam tip into an open ATP test device (i.e., UltraSnap or SuperSnap) tube. Using clean (autoclaved or wiped with alcohol) scissors, cut the sampling foam tip off the wand about 3 5 mm above the foam tip so that the foam tip drops into the ATP test device tube. Tip: For ease of use, place the ATP test device tube upright in a test tube holder. Note: Ensure that the foam tip is at the bottom of the ATP test device tube. 3. Replace the ATP test device swab back in the swab tube. www.hygiena.com 1 INS-ENDOSWAB-001-REVA 4. If using the EnSURE Touch luminometer, navigate to `Quick Test,' select `UltraSnap' and complete the information on the screen. Note: If using SystemSURE Plus, continue to the next step. 5. Activate the device by holding the swab tube firmly and using your thumb and forefinger to bend the bulb forward and backward to break the Snap-Valve. Squeeze the bulb twice to expel all the liquid down the swab shaft. 6. Shake for 10 seconds to bathe the EndoSwab foam tip in the liquid. Once activated, the sample must be read in the luminometer within 30 seconds. 7. Holding the luminometer upright, insert the entire ATP test device into the Hygiena luminometer. Refer to the instrument manual for operating instructions. In brief: a. If using the EnSURE Touch luminometer, close the lid and press "Run Test" to initiate the measurement. Results will be displayed in 10 seconds. b. If using the SystemSURE Plus® luminometer, close the lid and press "OK" to initiate the measurement. Results will be displayed in 15 seconds. Additional Information Interpretation of Results Hygiena luminometers are preset with Pass and Fail RLU limits (Table 1) that are based on industry standards and published study recommendations. Table 1. Recommended RLU Limits for EndoSwab with UltraSnap Devices. Luminometer EnSURE Touch SystemSURE Plus RLU Measurement 0 20 21 59 60 0 45 46 Result Pass Caution Fail Pass Fail Action No action required Follow SOP for retesting and recleaning procedures Reclean and retest No action required Reclean and retest Calibration and Controls It is advisable to run positive and negative controls according to Good Laboratory Practice. Hygiena offers the following controls: · ATP Positive Control Kit for ATP Test Devices · CalCheck LED Calibration Verification Device EndoSwab 2 INS-ENDOSWAB-001-REVA Storage and Shelf Life · Store at 20 to 25 °C (68 to 77 °F). · Do not use past the expiration date on the label. Disposal Used EndoSwab devices are not a biohazard and may be discarded in the trash. Safety and Precautions · Components of EndoSwab devices do not pose any risk when used in accordance with standard laboratory practices and procedures within this insert. · EndoSwab devices are for one-time use. Do not reuse. · For further safety instructions, refer to the Safety Data Sheet (SDS). Hygiena Liability Hygiena will not be liable to the user or others for any loss or damage, whether direct or indirect, incidental or consequential from use of these devices. If this product is proven to be defective, Hygiena's sole obligation will be to replace the product or at its discretion, refund the purchase price. Promptly notify Hygiena within 5 days of discovery of any suspected defect and return the product to Hygiena; please contact Customer Service for a Returned Goods Authorization Number. Contact Information For more information, visit www.hygiena.com/contact. For technical support, visit www.hygiena.com/support. EndoSwab 3 INS-ENDOSWAB-001-REVA