v.4.0 HTM Testing Explained... in fact everything you need to know about HTM but were too afraid to ask! Disinfection Traceability

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1 Testing Explained... in fact everything you need to know about but were too afraid to ask! v..0 Testing Packaging Storage Inspection Transport Sterilisation Cleaning Disinfection Traceability Washer Disinfectors & Washer Disinfector Performance Monitoring Sterilizers & Sterilizer Monitoring Manual Cleaning, Ultrasonics & Ultrasonic Cleaner Performance Monitoring KEY Log Books available for ALL test products FREE OF CHARGE Did you know? New Products Detergents, Added Extras, Accessories & cassette packages For use with all makes and models of decontamination equipment Knowledge! Reference to the guidelines Traceability & log books

2 Welcome to for Gummies New Products This booklet is designed to take you step-by-step through testing your decontamination equipment, with helpful hints and tips along the way. What is Decontamination? As quoted in Decontamination is the process by which reusable items are rendered safe for further use and for staff to handle..decontamination of instruments is a complex process that involves several stages, including cleaning disinfection, inspection and a sterilization step. Please refer to the diagram below for a summary of how each individual stage links together to complete the entire decontamination process. What is the importance of Decontamination? Simply Decontamination is required to minimise the risk of cross-infection between patients and between patients and staff. Harmful micro-organisims can be transmitted from person to person if the decontamination process is inadequate. What is? is a document released by the Department of Health and is to be used as a guideline in relation to decontamination in the Dental Practice. Artemis Inspection Lamp Refer to HTM01-05 with regards to visual inspection of your instruments. After cleaning, inspect instruments for cleanliness and check for any wear or damage before sterilization. The satisfactory completion of this step means that these instruments may be clearly designated as ready for sterilization. If its not clean. It cannot be sterilized. Pg 18, 3.18 What is the purpose of? It is intended to raise awareness of the decontamination of reusable dental instruments and your duty of care to staff and patients as a healthcare provider. Artemis Inspection Lamp M2058 Did you know?...compact, free standing, mains powered with LED lights for longevity. Decontamination Cycle Transport Acquire Clean With a washer-disinfector (WD); With or without an ultrasonic cleaner; manually Disinfect if a WD is used Easy Clean Keyboard Our waterproof Easy Clean Keyboard is medical grade and dishwasher safe, used by healthcare professionals worldwide Keys laser-etched to prevent fading Pg 39, 6.66 Use Store (max. 21 days) Location Facilities Equipment Management Policies and procedures Inspect Repeat cleaning if necessary Can be disinfected with healthcare grade sprays without being disconnected A quick connect cable allows for the keyboard to go straight from the dishwasher to the desk Package Store (max. 60 days) Steam-sterilize unwrapped (Type N) Steam-sterilize in vacuum sterilizer (Type B or S) Package Washable Keyboard M2056 Did you know?... There is no specific time frame for cleaning your keyboard, we recommend once a week dependent on traffic.

3 Manual Cleaning Until best practice is released, manual cleaning remains an integral part of the decontamination process Weekly Protein Residue Test Ultrasonic Cleaner Performance Monitoring PPE Disposable Face Visors Latex free & Anti fog (both sides) Lightweight & fit comfortably over a surgical mask or over prescription eyewear Disposable Visors 3E-Zyme (non foaming) Pg 35, 6.30 V Did you know?... Avoid touching the outer surface of the visor when removing & disposing of in clinical waste Pg 18, 3.15 As well as being used as part of your manual cleaning process, this detergent can be used in your ultrasonic and your Pico washer disinfector, therefore no need for multiple bottles. Non foaming and ph neutral Three in one, non-corrosive cleaner is safe and fast acting 3E-Zyme MED8035 x1 (L) Brushes Pg 63 D & F Brushes are designed to be single use Will not leave bristles inside the instrument Handy A3 wall chart available Variety of brushes available please call for further info Did you know?...some of our brushes are autoclavable If you are manually cleaning and looking to comply to are you aware of the comprehensive steps involved? Here are just a few: Measure the volume of water to ratio of detergent Using a mercury-free thermometer, continually record the temperature of the water Upon draining if water is heavily soiled, repeat the cleaning procedure Did you know?...you are required to document every step of this procedure! residual protein test as defined in HTM01-05 Did you know?... Denta Check is universal and can be used on any brand of ultrasonic / is not specific to the Medisafe range. (This is also applicable to washer disinfectors!) Standard PCD Kit Pg 58,13. Denta Check V Tests + 1 Control Test Quarterly* Soil & Ultrasonic Activity Test Quarterly* Soil Test Pg 58,13. The PCD (Process Challenge Device) & CEI (Cleaning Efficacy Indicator) kit has been designed to closely replicate a hard-to-clean dirty instrument. Easy to use place CEI in PCD & load into full machine Easy to read visual inspection that soil has been removed Quarterly as requested by unless stated otherwise by your Manufacturer for the entire Pico range if you have a PAYGo service this test is required monthly. & A test performed before your sterilization process to ensure your instruments are completely free of blood and saliva (forms of protein). This prevents cross contamination. Accurate results in 10 seconds Easy to use Clear colour change No incubation required No test more sensitive Cost effective Shelf life up to 2 years Control Test included to ensure batch has not been compromised Quarterly Ultrasonic Activity Test Foil Test Pg 61,15.6 The ultrasonic activity can be investigated by the erosion pattern created on the aluminum foil exposed in the tank for a short period Ideal width for performing the foil test High quality foil, does not perish Test 2 Test 1 Did you know?... This detergent can also be used as a pre-soak Did you know?... You are required to verify your manual cleaning process. To comply to you are required to carry out and record the results of a weekly protein test. Denta Check (shown overleaf) fulfills this requirement and can also be used to test your ultrasonic cleaner and your washer disinfector Standard PCD Kit M20230 (1 PCD & 12 CEI tests) Replacement CEI V x10 Did you know?...this is a visual indicator that helps you to identify that the load has been cleaned efficiently and can be used as a daily check. We use materials to closely replicate your dirty instruments using sheeps blood and additives layered onto a stainless steel plate. Therefore recreating your dirty instrument. Foil Roll MED Meters Did you know?... You should be comparing the erosion pattern against your last few test results to ensure the ultrasonic activity remains the same?

4 Autoclave Performance Monitoring Washer Disinfector Performance Monitoring The same tests can be used to test both your washer & Ultrasonic 1 Pg 58,13. Test 1 residual protein test as defined in HTM A test performed before your sterilization process to ensure your instruments are completely free of blood and saliva (forms of protein). This prevents cross contamination. B&D Test Pack Pg 25,.18 EN-ISO (CLASS 2 INDICATOR) EN-ISO Manufactured in EU OR Single use test pack for pre-vacuum STEAM sterilizers working at 13 ºC ºC for up to 3.5 min. Mimics air trapped within a hollow load and is made up of a length of tube attached to a small air tight container that holds a steam sensitive indicator. A successful process will remove air from the tube and then the container, allowing steam to contact the indicator causing a colour change reaction Compatible with B type autoclaves Indicator with self adhesive backing for easy documentation Easy to use easy to interpret brown when sterilized bruno quando sterilizzato braun wenn sterilisiert brun en stérilisé marron cuándo esterilizado Brązowe jeśli poddano sterylizacji Accurate results in 10 seconds 3 Easy to use Autoclave No.: Date: Store in dry, cool, dark conditions, before and after use Recommended 10 C - 30 C RH 30%-70% Clear colour change No incubation required The Valisafe Bowie Dick Test is a pre-assembled, disposable test pack for detection of defects in the sterilization process. It contains a large chemical indicator inside, which once the process is complete is removed from the pack and kept for your records. No test more sensitive Cost effective Shelf life up to 2 years Control test included to ensure the batch has not been compromised Denta Check Pg 25,.18 EN867 Helix Device Test 1 Daily Steam Penetration Test Weekly Protein Residue Test V B&D Test Pack 10 Tests +1 Control Test V x20 Helix Did you know?... Occasionally suitable for S type autoclaves, please refer to manufacturer Did you know?...easy to use, this weekly test confirms that your cleaning process retains the capability of removing protein. 1 Helix indicators V Did you know?... Our Helix devices are sold as part of a kit (1 device and 250 indicators). Indicators cannot be supplied separately as each device is calibrated for 250 uses. Quarterly* Soil Test d in EU Manufacture Manufactured LOT LOT The Class 6 indicator offers the highest level of proof of RSAL achievement of sterility assurance in your trays. NEW self adhesive indicators Easy to use & record; just peel off the back and stick inside your log book M PCD & 12 CEI tests V x10 Valisafe replacement CEI V x50 Did you know?...this is a visual indicator that helps you to identify that the load has been cleaned efficiently and can be used as a daily check. We use materials to closely replicate your dirty instruments using sheeps blood and additives layered onto a stainless steel plate. Therefore recreating your dirty instrument temperature & Steam Class 6, 3.5 min V x250 Did you know?...verify your N type autoclave with this independent test The Class indicator monitors time and temperature parameters and are dual. (250 indicators split into 500 tests) Clear accurate colour change Easy to interpret, easy to record For use in every tray or item Class V x500 Did you know?...if used in conjunction with Class 6 Indicators in every tray, this provides the highest level of sterility assurance IVE Monitors critical paraters for sterilisation; time, Valisafe replacement CEI LOT Release batch. No further action needed LOT Manufactured in EU Spot of test soil completely removed Manufactured in EU Dual multi parameter indicator EN-ISO turn indicator from blue to dark geay or black otherwise by your Manufacturer for the entire Pico range if you have a PAYGo service this test is required monthly. Dual multi parameter indicator EN-ISO turn indicator from blue to dark grey or black Successful cleaning process: UN LOT DUAL MULTI PARAMETER INDICATOR Class 121 ºC - 13 ºC In case of repeated insufficient cleaning process: Call service technician EU Manufactured in EU Manufactured in Spot of test soil slightly visible indicator Dual multi parameter EN-ISO turn indicator from or black blue to dark geay indicator Dual multi parameter EN-ISO turn indicator from or black blue to dark grey ER INDICATOR DUAL MULTI PARAMET Class ºC 121 ºC - 13 ER INDICATOR DUAL MULTI PARAMET Class ºC 121 ºC - 13 Repeat test in EU in EU indicator parameter Dual multi EN-ISO from turn indicator grey or black blue to dark Manufactured d in EU LOT INDICATOR PARAMETER Class ºC 121 ºC - 13 indicator parameter Dual multi EN-ISO from turn indicator geay or black blue to dark DUAL MULTI r indicator paramete Dual multi EN-ISO conditions Sterilizing from turn indicatorgrey or black blue to dark DUAL MULTI PARAMETER INDICATOR Class 121 ºC - 13 ºC Easy to read visual inspection that soil has been removed Quarterly as requested by unless stated Standard PCD Kit V Art. No.: Test 2 LOT & Check wash, temperature, dosage and time INDICATOR METER Class - 13 ºC 121 ºC I PARA DUAL MULT Manufacture Do not release batch r indicator paramete Dual multi EN-ISO conditions Sterilizing from turn indicatorgeay or black blue to dark Spot of test soil visible The PCD (Process Challenge Device) & CEI (Cleaning Efficacy Indicator) kit has been designed to closely replicate a hard-to-clean dirty instrument. Easy to use place CEI in PCD & load into full machine Pg 61, 15.5 (Load Check) LOT Spot of test soil visible Dual Class Pg 61, 15.3 V Art. No.: Spot of test soil completely visible 3.5 min Indicator Insufficient cleaning process: Class 6, self adhesive INDICATOR PARAMETER DUAL MULTI Class ºC 121 ºC - 13 Reference indicator: Test soil spot completely visible To be used in conjunction with the Load Check INDICATOR METER Class - 13 ºC 121 ºC Action needed I PARA Assessment DUAL MULT Standard PCD Result Test 2 To be used in conjunction with the Automatic control test Pg 58,13.

5 Compliance to Best Practice Compliance to Best Practice at the touch of a button PICO Compliance to Best Practice at the touch of a button Reliance PC+ Ultrasonic PICO Washer Disinfector All Pico s (worktop and floor standing) share one touch operation, efficient compliance and give you fully automated traceability, as outlined in guidelines and standards. PICOevo - NEW PICO XL Ultrasonic instrument cleaner. compliant HTM 2030 compliant With interlocking lid Ultra quiet Fundamental safety and security Traceability Reliance PC+ MED1119PC Lumen Flushing provides powerful cleaning for hollow or lumened devices. Hand pieces are reprocessed thoroughly inside and out, guaranteeing complex / critical instruments are free from soil residue. See Washer Disinfector page for more in the range New innovative design increases instrument capacity and removes the need for a steam exhaust outlet by means of an internal condenser. Fast, simple, safe and reliable. Automated detergent dosing, forced air drying system, universal hand piece connectors, double rotary spray arms, in built water treatment system The XL slim under-counter model allows busy surgeries to reprocess high volumes. They carry all the features of benchtops but with higher volume lumen washing / disinfection facilities. Optional extras include drying cycles and Ezee Clip trays for maximum throughput thus optimising efficiency. Cleans up to 8 handpieces HTM01-05, EN ISO 15883, EN1717ISO PICO XL MED1301 Niagara Nano PICOclave Autoclaves PICO evo hot/cold MED1360 PICO XL with drying MED1316 PICO XXL PICO WORK STATION - NEW COMING SOON! Call our fully trained team + (0) Class B vacuum steam sterilizer compliant EN compliant Rapid vacuum / Standard cycles Touch screen Large 17 litre capacity / 22 litre See Autoclave page for more in the range The 600mm wide under-counter model allows busy surgeries to reprocess high volumes. They carry all the features of benchtops but with higher volume lumen washing / disinfection facilities. Optional extras include drying cycles and Ezee Clip trays for maximum throughput, optimising efficiency. Cleans up to 12 handpieces PICO XXL MED1300 Pico Work Station MED1370 PICO XXL with drying MED1315

6 New products Sterilizers & Sterilizer Monitoring Vacuum (Type B) Autoclaves Easy Clean Mouse Pg 39, 6.66 PICOclave 21ED 22 litre* PICOclave 21ED 17 litre* Our fully submersible Easy Clean Mouse is also dishwasher safe, helping you to comply with guidelines. It contains a silver seal technology which protects the mouse between washing With 2 K gold-plated USB connector to prevent corrosion and is manufactured to IP-68 standards Class B vacuum steam sterilizer. compliant EN compliant Rapid Vacuum / Standard cycles Touch screen Large 22 litre capacity Class B vacuum steam sterilizer. compliant EN compliant Rapid Vacuum / Standard cycles Touch screen Large 22 litre capacity Washable Mouse Did you know?... Dishwasher safe and universal M2057 PICOclave 21ED 22L MED1905 PICOclave 21ED 17L MED1930 Did you know?...the whole of Europe uses Vacuum Autoclaves - buying less expensive Type N machines may not serve you well in the future Also available in Non Vacuum Heat Sealer Pg 27,.26 Easy, safe and reliable sealing for sterile and hermetic packaging of your medical tools without the risk of burning the packaging material Non Vacuum (Type N) Autoclaves Autoclave Tape Pg 61, 15.8 Process Indicator Pen - PIP Pg 27,.26 Heat Sealer Compact table-top machine; easy-fit into surgery environment Easy to use with light and acoustic signal Can accommodate a larger selection of roll widths A handy buzzer to indicate end of seal time and seal bar closure M20550 Did you know?... Seal your pouches to fit your instruments- no waste! Colour change upon exposure to heat Individually marked rolls with lot number and expiry date Non-toxic Lead free Cost effective Single rolls coming soon V35000 V mm 8 rolls per bag 2mm 36 rolls per bag Did you know?...autoclave tape will change colour when simply exposed to heat. Colour change does not confirm sterility The Process Indicator Pen or PIP pen can be used on all wrapped materials to indicate specific information requirements such as dentists / patient s name, tray name and date. When exposed to the steam sterilization process the PIP pen ink changes from purple to green to indicate to you which packs have been sterilized. Writes for over 00m Non-toxic Lead-free V Pen Did you know?... Are you signing & dating your pack? Also include the expiry date!

7 Detergents Traceability & Log Books 3E-Zyme (non foaming) Pg 18, 3.15 Medi-pH-Safe (aluminium friendly) Pg 18, 3.15 Traceability Medi-Logger Pg 18, 3.19 Printer Pg 18, Ezyme - Is effective against and digests ALL residues and deposits normally found on surgical instruments and apparatus including proteins, lipids, carbohydrates and mucopolysaccharides. Normal dilution rate for manual cleaning is 3-7mls of detergent to each litre of water dependent on how heavily soiled the instruments are. Uses a combination of three high performance enzymes A unique formulation designed especially for use in hard water areas, which gives the cleaning benefits of an alkaline detergent with the protection offered by an enzymatic detergent ph9 compositions result in fast efficient cleaning at high temperatures Non foaming and low dilution rate 3E-Zyme MED8035 x1 (L) Medi-pH-Safe M20011 x1 (5L) Medisafe s new Medi-logger can be adapted to fit most disinfection equipment. The data is stored in an active format which enables the user to identify the time that the data was captured for analysis. This information is encrypted and cannot be changed OR For monitoring and documenting all operational functions / parameters performed by the Pico washer disinfector range. AWT Did you know?... If your washer is validated & calibrated using one of the above detergents, you are required to revalidate your machine, if you decide to use an alternative detergent. Failure to do this could invalidate your warranties or even damage your machine. Pg 18, 3.15 Deconozyme Advanced Medi-Logger Washer Medi-Logger Autoclave M20070G M20070F x1 x1 Did you know?...please call to ensure the Medi- Logger is compatible with your equipment, if not part of the Pico / Medisafe range. Printer MED101 x1 Printer roll MED101.1 x1 Did you know?...does not require ink information is thermally printed Although the Medi-Logger or Printer is recording the output information of your machine, it is still a requirement to independently validate your cleaning process with periodic testing. When audited you may be required to provide documentation that is evident of the successful periodic test and maintenance of your decontamination equipment For use in addition to the detergent to keep your machine running efficiently and to avoid limescale build up AWT M20059 x1 (L) AWT AWT MED MED T x6 (500ml) x2 (500ml) Did you know?... Only suitable for Medisafe Pico washer disinfectors New technology, now with water soluable tablets for pre- auto dosing Pico washer disinfector machines. Did you know?... Can also be used as a one dose tablet for ultrasonics and manual cleaning Medisafe introduce our new annual log books... requests that you provide evidence of a validated cleaning process. Keeping all your records in different places can be confusing and poses a threat of records becoming damaged or even lost. Keep all of your records in our annual log book which provides daily, weekly, monthly and quarterly record sheets. Ultrasonic log book coming soon!

8 Added Extras Cassette Packages Are you maximising the full capacity of your machine? Antibacterial Pen Eye Shields Pg 35, 6.27 Benchtop Package PICOevo Consumable Package Protect your staff and your patients Do you chew your pen? Don t pass on your germs! Kills 99.9% of harmful bacteria and viruses Effective against MRSA, C.Difficile, H1N1, Salmonella, Enteriditis & Norovirus Antibacterial Pen Antibacterial Pen V V Pen x100 Pens Did you know?... This is the only pen approved to British Standards Available in 10 stylish colours for easy identification Latex free Anti-fog & mist Light weight & comfortable distortion free Protects from harmful debris & splashes Fits with surgical mask and over prescription eyewear Eyeshields MED frames (assorted colours) plus 50 lenses Did you know?...various pack sizes available, please ask for details & prices 1 3E-Zyme (L) 2 AWT (0.5L) 2 Ezee clip cassettes, size 20 Ezee clip cassettes, size 10 2 Ezee clip cassettes, size 3 1 Burr basket Benchtop Package XL Package M E-Zyme (L) 2 AWT (0.5L) 8 Ezee clip cassette, size Ezee clip cassettes, size 10 1 Burr basket Manifold Package XXL Package M20162 Ezee Clip Cassette Foam Spray Pg 16, 3.5 Made from stainless steel the Ezee clip cassettes can be used as part of the cross infection/decontamination process ensuring staff & instruments are protected throughout. These cassettes will enable you to process more instruments per wash cycle and allow the greatest surface area of each instrument to be cleaned & thermally disinfected. When immediate reprocessing is just not possible. Instruments cleaned as soon as possible after use are often more easy to clean than those left for a number of hours. The enzyme foam spray is intended to maintain a moist humid environment. PH netural and safe and effective for stainless steel, aluminium and brass instruments Foam Spray MED x1 (500ml) 2 3E-Zyme (L) 1 AWT (L) 8 Ezee clip cassettes, size 20 8 Ezee clip cassettes, size 10 Ezee clip cassettes, size 3 2 Toast Racks 1 Burr basket XL Package M E-Zyme (L) 1 AWT (L) 12 Ezee clip cassettes, size Ezee clip cassettes, size 10 3 Toast Racks 2 Burr baskets XXL Package M2007 Ezee clip cassettes available in size 3,5, 10 & 20 in various colours Did you know?...prevents soil hardening on your dental instruments Did you know?... Reduces the risk of sharps injuries

9 Check List PERIODIC TESTING Ultrasonic Weekly Protein Test Quarterly Soil Test Quarterly Foil Test Washer/Disinfector Weekly Protein Test Monthly / Quarterly Soil Test Autoclave Daily Steam Penetration Test (Vac) Indicator Strips* (Vac & Non Vac) To see our testing products and machines in action, please head to : To view our product demo videos. * See manufacturers recommendation W: Please Contact: or phone + (0) for details of your nearest distributor Medisafe and Medisafe International are trading names of Medisafe UK Limited Prices quoted excl. delivery & VAT Testingforgummies MB 09/12 UK REV10 alisafe Valisafe is a division of Medisafe UK Ltd Medisafe International Twyford Road, Bishop s Stortford, Hertfordshire CM23 3LJ, U.K. T: + (0) F: + (0) E:info@medisafeinternational.com

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