ProFormanceTM Cleaning Verification Products

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ProFormanceTM Cleaning Verification Products See the Quality of Water with AquaTest 3-in-1 Water Quality Test Strips Water quality is key to the performance of cleaning agents. In particular, hard water binds up detergent molecules, preventing them from breaking down the soil. Further, these molecules are often a source of staining and pitting of surgical instruments. Enzymes used in detergents are highly influenced by the ph level of water. An improper ph level can lead to the partial or complete inactivation of the enzymes. Total alkalinity measures the Order# amount of alkaline buffers in water, protecting it against sudden changes AT101 in ph. Total alkalinity is the key to maintaining water s balance. Can you see water quality? With the AquaTest strip you can. In less than 30 seconds, this simple to use test shows you 3 key water quality statistics identified in AAMI TIR34: ph, Alkalinity and Hardness. With the easy to interpret color change these values can be measured and recorded for the thorough documentation of water quality. Hardness is measured from soft (0) to very hard (1000 ppm CaCO3). ph is measured from very acid (2) to very alkaline (12), encompassing the optimum range for enzyme cleaners. AquaTest reports total alkalinity from 0 to 500ppm CaCO3. Visualize the Temperature with TempaChekTM Water temperature is a key to cleaning performance. In general, the warmer the water, the more effective the cleaning action. However, with each method and at each stage of cleaning, it is important that the water not exceed a certain temperature. When using an Automated Instrument Washer, the initial rinse water should not exceed 45 C (113 F) and it is suggested temperatures remain significantly below this level. At 45 C, blood is cooked on to instruments and becomes highly insolvent - making TEMP-170 TEMP-90 removal very difficult. Temp-90 is a simple method for verifying and documenting the temperature. Water temperature is also the key source of thermal disinfection. TempaChek-170 provides a permanent and independent measure of the surface temperature achieved during this critical phase of the process. TEMP-HL The TEMP-HL is an irreversible, disposable thermometer that has the ability to indicate both high and low temperatures to ensure that reprocessed items stay within a desired temperature range during transportation of goods. When the temperature gets to 0 C, a distinct clear to red color change occurs. Conversely, when the temperature exceeds 29 C, the color changes from white to black. Call:800-521-6224 1 Fax:586-491-2113 www.hmark.com

Log the Environmental Conditions with TEMPUSB Devices The TEMP-USB-TH measures over 250,000 temperature and humidity readings ranging from -22 to 176F and 0 to 100% relative humidity. This temperature and humidity data logger is perfect for a CP department where temperature and humidity control is crucial. TEMP-USB-TP TEMP-USB-TH The TEMP-USB-TP offers solely temperature readings but has the advantage of dual temperature probes which can gather over 250,000 readings (-40 to 257F) via two separate probes. This temperature data logger is perfect for a CP department where temperature control is crucial. #TCDL2: TempaChek-DL The Temp DL USB is a thermologger capable of measuring the water temperature through the cycle. With the included software, plug the datalogger into your PC and download, graph and save the full temperature profile of your washer. Find the Right Level With The Healthmark Watermark The Healthmark Watermark is a bumper sticker sized liquid crystal thermometer with a "water fill line" that adheres to the inside of a manual or ultrasonic bath. Following the instructions of your detergent manufacturer, determine the appropriate water level for the bath. In the white space, record the volume of water. Staff should then be instructed as to the amount of detergent to #TEMP-WMK add to the bath, in accordance with the detergent manufacturer's IFU. Unique to the Healthmark Watermark is an easy to read liquid crystal thermometer located below the fill line. By monitoring the temperature (70o-150oF), staff can be sure the Order# TEMPACHEK-LC solution is in the proper range as directed by the detergent manufacturer's IFU. Measures 12"w x 3"h. The TEMPACHEK-LC is a liquid crystal thermometer that can be mounted to the side of the bath, below the water line. This inexpensive and reusable thermometer will display the real time temperature of the bath, providing valuable feedback about the appropriateness of the bath temperature when compared to the temperature recommended by the detergent manufacturer. 2

Mark the Cleaning Reach of your Cart Washer with CartWashCheck Order# CW-101 Cart washers are important tools in the overall effort to reduce cross contamination. Often they are used to clean not just surgical case carts, but also basins, instrument trays, wheel chairs and other supply and patient transport equipment. The CartWashCheck is designed to challenge the mechanical efficiency of the cart washer. These convenient tests can be quickly and easily adhered to any metal surface with the peel off adhesive back. Place these tests on surfaces that are furthest from the washer jets or in areas where coverage is the most difficult. The dark blue square should wash, leaving a white square. This demonstrates that water is reaching the area tested and indicates proper mechanical action. Further, the test reports common maximum temperature levels cart washers are programmed to reach: 120 F, 150 F & 180 F. The irreversible thermometer reports the highest temperature reached during the cycle. Observe the Inside-Out with LumCheck and FlexiCheck LumCheck is the first test designed as an independent check on the cleaning performance of rigid scope cleaners. The LumCheck is made up of three key components: The test soil, the stainless steel plate and the LumCheck holder. The soil is composed of blood components mixed and applied in a precise Order# WLC-101 manufacturing process. As a result, it provides a consistent challenge to the cleaning effectiveness of the MIS cleaning device. The stainless steel plate is scratched, replicating the uneven interior of lumen instruments. The holder enables the attachment of the test to the cleaning equipment and also replicates the cleaning challenge of cannulated instruments. After Holder: #WLC-102 running the LumCheck test through a cleaning cycle, remove the test from the holder. Examine the stainless steel plate for the presence of soil. The LumCheck should be visually clean. LumCheck complies with Order# FLEXCHK-101 ASTM Guide D7225. The FlexiCheckTM is a three part kit that simulates a flexible endoscope channel and is designed to challenge the cleaning efficiency of endoscope washers. The kit includes a flexible tube, attached to a stainless steel lumen device. The test coupon is placed in the lumen and the entire device is hooked up to the irrigation port of the washer. The test coupon includes two soils, components of blood soil and polysaccharide soil. These soils are the types which are often found within the channels of flexible endoscopes and represent a significant cleaning challenge. When processed through a cleaning cycle, the endoscope washer should completely remove both soils from the test coupon. 3 Order# FLEXCHK-102

Reveal the Hidden Areas of Surgical Instruments with the TOSITM Instrument Washer Test Order# WT101 #WT-111 Before Fibrin Hemoglobin Pass Reveal the hidden areas of instruments with the TOSI washer test, the easy to use blood soil device that directly correlates to the cleaning challenge of surgical instruments. TOSI is the first and only device to provide a consistent, repeatable, and reliable method for evaluating the cleaning effectiveness of the automated instrument washer. This is possible, because the blood soil is manufactured to exacting specifications each and every time. When metered on to the stainless steel plate, the TOSI is completely analogous to a stainless steel instrument soiled with dried blood. Placed in the see-through plastic holder, the challenge is identical to the areas of instruments typically hidden from view (i.e., box locks). The routine use of this test will help ensure that your instrument washer is performing at a consistent level, enhancing the routine visual inspection of instruments. TOSI complies with new AAMI and AORN Guidelines as well as ASTM Guide D7225. New! WRL-001 Make the Invisible, Visible with SonoCheck It is invisible to the human eye, but with the SonoCheck you can test for the presence of cavitation energy - the cleaning power - of your ultrasonic cleaner. Ultrasonic cleaning is a result of sound waves introduced into a cleaning liquid by a series of transducers. The sound travels throughout the tank and creates waves of compression and expansion. During the expansion wave, molecules of the liquid are Order# TI108 pulled dramatically, ripping them apart. This creates microscopic vacuum cavities. As the pressure around these cavities becomes greater, they collapse violently, forming voids - a process called cavitation. This creates extreme temperature and combines with the velocity of the liquid jet to deliver a very intense cleaning action in a minute area. When the ultrasonic cleaner is supplying sufficient energy and conditions are correct, SonoCheck will change color. Problems such as insufficient energy, overloading, water level, improper temperature and degassing will increase the time needed for the color change. In the case of major problems the SonoCheck will not change color at all. 4

Test Beyond What Can Be Seen with HemoCheck Stains come in all sizes, shapes and intensity. Sometimes a stain can appear quite benign, or not be easily detected by the human eye. Go beyond what you can see and test the cleanliness of Order# HC-101 instruments with the HemoCheck blood detection kit. Finding a stain on an instrument that has gone through reprocessing is never good. If the stain is blood, the implications are even more serious. Take the guess work out of evaluating the cleanliness of instruments with the HemoCheck blood residue test kit. The HemoCheck is Swabs for various an all-in-one test, provides a result in 30 seconds, is simple to inter- diameter lumens pret and indicates blood residue down to 0.1µg. Significant traces of blood indicate an inadequately reprocessed instrument and is a rich source for cross contamination. To use the HemoCheck, simply swipe the surface of the instrument, drop the swab in the activated indicator, 10 ug 1 ug 0.1 ug shake vigorously, wait for 30 seconds and check for color change. If the swab remains yellow, the instrument is free of blood. If any area of the swab turns green or blue, the surface harbors blood residue and should be reprocessed. If many instruments are found to be soiled, a thorough evaluation of the decontamination processes should be conducted. HemoCheck complies with ASTM Guide D7225. Expose Contaminants on Surfaces with ProChek-II It looks clean. But is it? Take the guess work out of evaluating the cleanliness of surfaces with the ProChek-II protein swab test. The ProChek-II is simple to use, provides a rapid result, is an all-in-one test, and is easy to interpret. The ProChek-II measures for residual protein on surfaces. Protein is a significant component of bioburden. Traces of protein indicate an unclean surface and a likely source of cross contamination. A successful test is a documented record of a properly cleaned surface. To use the ProChek-II, use the supplied premoistened swab, swab the surface of Order# PT-202 the item being tested, cut the swab into the vial and shake vigorously. If the color of the liquid remains brownish yellow, the Swabs for various surface is demonstrably clean. If the liquid diameter lumens or any part of swab turns blue, the surface harbors protein and should be re-cleaned. The test is sensitive to 1 µg of protein. 5

See Clean Inside a Scope with EndoCheckTM Flexible endoscopes are notoriously difficult to clean. More difficult still is verifying that the cleaning has been adequate. Now there is a test for checking the cleanliness of the biopsy channel of the flexible endoscope. The EndoCheck is a miniature chemistry kit that is simple to use and interpret. Simply swab the biopsy channel of the scope with the included soft-tipped long probe, clip off the swab into the vial. Mix the activating agent, shake vigorously, wait and then Blood: EDH-xxx or Protein:EDP-xxx check for a color change. Depending on the type of test used, a color change indicates that blood residue or protein residue remains in the channel, and should be reprocessed. EndoCheck complies with ASTM Guide D7225. Swab diameter sizes from 1.0 5.0 mm are available. Identify the Presence of Residual Organic Soils with ChannelCheck ChannelCheck is the first product capable of testing virtually any lumened instrument for residual organic soils, no matter the channel size. ChannelCheck tests for three common organic soils at once: blood, protein and carbohydrates. US Patent #6,447,990 B1 recovered water for 10 seconds. Simply flush an individual channel with commercially available, prepackaged Order# UCC-101 sterile water (i.e. sterile water for irrigation) and recover that water in a clean (preferably sterile) container. Then dip and swish the test strip in the Remove the strip, wait 90 seconds and then compare the color of the pads to the results chart. Should any of the pads indicate there is residual soil, reclean the device and then retest. 6

10 Minute Gram Negative Test Flexible endoscopes are marvelous diagnostic tools, but they are a challenge to clean and disinfect/sterilize. Modern AER s are effective tools for rendering scopes safe for use on the next patient. But what about the endoscope that is not properly reprocessed? Endoscopes in storage are an excellent environment for the growth of bacteria. Risks for bacterial contamination include organisms that survived disinfection and/or contaminants from the final rinse water. An alcohol flush followed by drying with air is meant to dry the internal channels of the scope, but like any process, failure is a possibility. Order# HTK-1 Numerous incidents of contaminated endoscopes due to a failure in reprocessing are well documented. The sources of such failures include inadequate cleaning, ineffective disinfection, failure to follow recommended reprocessing practices, flaws and complexity inthe design of endoscopes and/or AERs. Flexible endoscopes are susceptible to contamination after reprocessing because they are highly contaminated after use, are a physical challenge to adequately clean, disinfect, dry and the terminal process is high level disinfection (Disinfection and Sterilization: What s New, William Rutala, APIC 41st Annual Conference, June 8, 2014). The HangTimeKitTM utilizes a unique enzyme detection method. The easyto read fluorometer checks for possible contamination by reading telltale fluorescence in the recaptured water. If the reading is positive for Gram-negative bacteria, reprocess the endoscope.if contamination is discovered in a single scope multiple times, or multiple scopes are found to be contaminated, further investigation should be undertaken (white paper available upon request). Inspect the Cleanliness of Robotic Arms with the RAC Test Kit With the RoboticArmCheck (RAC) confirm the proper cleaning of surgical robotic arms. These high tech pieces of equipment have a limited use life. Improper cleaning can lead to the buildup of bioburden inside of the instrument - representing not only a source of cross-contamination to patients, but shortening the useful life of the instrument itself. The RoboticArmCheck is an easy to use and interpret method for testing these instruments, providing a result in less than 30 seconds. Sample the inside of the robotic arm with a moistened swab, and expose the swab to a simple reagent test. A color change to green/blue indicates that blood remained in the lumen of the instrument, requiring recleaning. No color change indicates the instrument is clean and is ready for the next step in reprocessing. Order# RAC-001 7

Comply with AORN & AAMI Guidelines for Comprehensive Weekly Testing with ProFormance Washer Test Kits New guidelines from AORN (Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Section XXII.a) and AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities) call for weekly testing of the automated instrument washer. Our Weekly Washer Test Kits are the comprehensive solution. These kits include tests to measure water temperature, water quality, cleaning efficiency, and directly test residual soil left on instruments, all parameters cited by AAMI and AORN as crucial for the routine testing of instrument reprocessing. 3 Level Washer Instrument Rack Kit Qty Test 2 AquaTestTM 1 TempaChekTM-90 3 TempaChekTM-170 3 TOSI 4 Level Washer Instrument Rack Kit Qty Test 2 AquaTestTM 1 TempaChekTM-90 4 TempaChekTM-170 4 TOSI ProFormanceTM Washer Monitoring Weekly Log Sheet: 3 Level Rack (AWTK-3L) Date: Facility: Water Quality Aquachek Washer: Target Values (circle result) Rack No: Name: Cold Water Hot Water p: ph Level: ph Level: A: Alkalinity: Alkalinity: H: Hardness: Hardness: Pre-Wash Temperature TempaChek-90 Circle Result Pass Fail Temperature Should Not Exceed 100oF Record Result (darken temperatures reached) Verification of Record Result Cleaning (circle result) Efficacy Proformance Bottom Middle Top 0 1 2 3 4 5 Thermal Disinfection TempaChek-170 Target Temp: Record Result (circle highest temp achieved) Copyright Healthmark 2009 1 AWTK-3L/12/09 3 Level Rack Log.indd 1 12/16/2009 2:33:18 PM Tunnel Washer Kit Qty Test 2 AquaTestTM 1 TempaChekTM-90 1 TempaChekTM-170 1 SonoCheckTM 1 TOSI Ultrasonic Cleaner Kit Qty Test 2 AquaTestTM 3 SonoCheckTM 1 TOSI 1 TempaChekTM- LC ProformanceQA Tired of writing down QA test records? Healthmark now offers a simplified solution to keep up to date log records on your your PC. ProformanceQA is a single database that allows you record key statistics for a variety infection control records. This program not only records your data, it uses that information to generate impactful reports you can use to track the performance of your cleaning equipment over a period of time. ProfomanceQA Datalog ProfomanceQA Results Report 8 ProfomanceQA Results Chart