HTM 01-05 for DummiesTesting Explained... infact everything you need to know about HTM 01-05 but were too afraid to ask!

Ultrasonics &Ultrasonic Cleaner Performance Monitoring

Washer Disinfector &Washer Disinfector Performance Monitoring

Cleaning Solutions

Sterilisers & Steriliser Monitoring

Decontamination AccessoriesKnowledge!Reference to the HTM 01-05 guidelines

Expert advise!

PICO Plus Flush MED-FP1159

PICO Flush with drying MED170

PICO XL MED1301

PICO XL with drying MED1316

PICO Flush

PICO XXL

Decon Tower - Stainless Steel POA

Decon Tower - Epoxy Coated White POA

Decon Tower, Is space an issue?

PICO XL

PICO XXL MED1300

PICO XXL with drying MED1315

Patented Pulse 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.• Cleans up to 6 hand pieces

The 600mm wide under counter model allow busy surgeries to reprocess high volumes. They carry all the features of benchtops but with higher volume lu-men washing / disinfection facilities. Optional extras include drying cycles and Ezee Clip trays to maxi-mum throughput, optimising efficiency.• Cleans up to 12 handpieces

This compact unit can be built to accommodate a combination of devices in various configurations, al-lowing good accessibility for confined spaces. The orientation of the storage and drawer systems as-sist in the instrument use / reprocessing cycle further helping you with compli-ance and standardisation to HTM 01-05. Concealed storage at the base is ideal for detergents and RO units & free glide casters ensure easy maneuverability.

All Pico’s (worktop and floor standing) share “one touch” operation, efficient HTM 01-05compliance and give you fully automated traceability, as outlined in the guidelines and standards.

The XL slim under counter model allow busy surger-ies to reprocess high volumes. They carry all the features of benchtops but with higher volume lumen washing / disinfection facilities. Optional extras in-clude drying cycles and Ezee Clip trays to maximum throughput, optimising efficiency.• Cleans up to 8 handpieces

PICOCompliance to “Best Practice” HTM 01-05 at the touch of a button

Standard PCD TOSI

ProTEST

Standard PCD V3502090 x1 £75.00 Tosi MED100.00 x12 £72.00

ProTEST M20133 x50 tests £147.50 ProTEST ‘Q’ V3503895 50 tests £215.00

The Standard PCD is a consistent reproducible method of monitoring the cleaning efficiency of your Washer Disinfector

• Stainless steel tray for testing of Valisafe CEI• Conforms to ISO 15883• Easy to use - Easy to read• No mess• Non toxic

A weekly HTM 2030/ HTM 01-05 protein detec-tion test. Detects low levels of protein residue; in less than 15 minutes.

• A pre-prepared test which is easy to use• Swab shows blue dot indicating protein resi-dues down to 1μg sensitivity (equal to or greater than Ninhydrin)• Incubation is not required

Ready to use rapid protein residue detection system. Protein residue test in accordance with EN ISO 15883-1

• HTM 01-05 compliant• Results in 10 minutes• Biuret sensitivity• Ninhydrin safety• Pre moistened swab• Easy to use• 18 month shelf life

A washer disinfector function test that checks the even distribution of cleaning efficiency within your machine and can be used during a normal cycle.

• Transparent cover enables a visual check• The device simulates the joint of a surgical instrument• A pre-prepared test replicating correlated blood• Easy to use no training required

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Washer Disinfector &Washer Disinfector Performance Monitoring

HTM 01-05Pg 58,13.4

HTM 01-05Pg 58,13.4

HTM 01-05Pg 58,13.4

HTM 01-05Pg 58,13.4

OR

OR

This is the Protein Residue Test as outlined in HTM 01-05

This is the Cleaning Efficacy Test as outlined in HTM 01-05

This is a quarterly cleaning efficacy test that replicates soil trapped inside hinged instruments

This is our daily test and is a visual indicator that helps you identify that the load has been cleaned efficiently

Easy to use, this weekly tests to confirms that the clean-ing process retains the capability of removing protein

This test meets & exceeds the highest current level of sensitivity for protein residue detection

ProTEST Quick

PICOclave 21ED 22L MED1910 PICOclave 17ED 17L MED1915

PICOclave 21ED 22 litre

PICOclave 17E 17L MED1920PICOclave 21E 22L MED1900

PICO clave 17ED 17 litre

PICOclave 21E - 22 litre PICOclave 17E - 17 litre

Class B vacuum steam steriliser• HTM 01-05 compliant• EN 13060 compliant• Rapid Vacuum / Standard cycles• Touch screen• Large 22 litre capacity

Class B vacuum steam steriliser• HTM 01-05 compliant• EN 13060 compliant• Rapid Vacuum / Standard cycles• Touch screen• Large 17 litre capacity

Class N steam steriliser• EN 13060 Compliant• Class N• Non-vacuum• Easy to operate• 22 litre capacity

Class N steam steriliser• EN 13060 Compliant• Class N• Non-vacuum• Easy to operate• 17 litre capacity

AutoclavesCompliance to “Best Practice” HTM 01-05 at the touch of a button

Vacuum (Type B) Autoclaves

Non Vacuum (Type N) Autoclaves

Type N Autoclaves are not suitable for handpieces or hollow lumens!.

The whole of Europe use Vacuum Autoclaves - buying less expensive Type N machines may not serve you well in the long run.

EN867 Helix Device

Class 6, 3.5 min Indicator Dual Class 4 (Load Check)

Helix V3502034 x250 £130.00B&D Test Pack V3501020 x20 £52.00

Class 6, 3.5 min V3502060 x250 £35.50 Class 4 V3502038 x500 (x2) £35.50

B&D Test Pack

The Valisafe EN 867-5 Helix Device is an accurate, cost effective way of ensuring that your Type B table top sterilizer is performing correctly.

• Conforms to EN 867 Part 5• Specifically engineered for B type (vacuum assisted) table top sterilizers• Daily test requirements as stipulated in national standards• Easy to use - Easy to interpret• Self adhesive backing for documention purposes

The Valisafe B&D test pack fulfils the requirements of EN 285, EN ISO 17665 & EN ISO 11140–4• Independently validated to mirror the original Towel pack • For porous loads only• Diagnostic capabilities: air removal; wet steam; super heated steam or presence of non-condensable gases• Clear and accurate colour change • Easy to interpret – easy to record • Non-toxic, single use, disposable

The Class 6 chemical indicators offer the highest level of proof of the achievement of Sterility Assur-ance in your trays and items.• Conforms to EN ISO 11140–1 Class 6• Specifically calibrated to 3.5 min at 134˚C cycle• Monitors critical parameters; Time; Temperature; Steam• For use in every tray or item• Clear & abrupt colour change - Easy to interpret

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• Conforms to EN ISO 11140–1 Class 4• Monitors all 121˚C to 134˚C steam sterilization cycles• Clear accurate colour change • Easy to interpret - easy to record• For use in every tray or item• Non-toxic• Strips dividable to make 500

www.valisafe.com

Sterilisers &Steriliser Monitoring

HTM 01-05Pg 25,4.18

HTM 01-05Pg 25,4.18

HTM 01-05Pg 56

&

OR

This is the Daily Steam Penetration Test

This is the Automatic Control Test

This must be used at the start of each day prior to the sterilisation cycle as stated in HTM 01-05

This can be used daily and gives you the reassurance that your load including dental handpieces have been processed

This should be used on a daily basis as part as your automatic control test.

Class 4 indicators should be used in each tray, every cycle and give load sterility assurance.

EN13060 Vacuum Autoclave compliant ONLY

This is your daily Load Check

DentaSonic MED1800

DentaSonic

PICOClave

PICOUltrasonic Washer Disinfector

Autoclaves

UltrasonicsUltrasonics are used for cleaning instruments with hinges or intricate parts.

Washer DisinfectorsWasher Disinfectors are used as the preferred method for cleaning dental instruments.

AutoclavesAutoclaves are used to sterilise instruments after they are thor-oughly cleaned

HTM 01-05 Pg 19, 3.21

HTM 01-05 Pg 17, 3.13

HTM 01-05 Pg 22, 4.2

Machine types

Ultrasonic instrument cleaner • HTM 01-05 compliant• HTM 2030 compliant• With interlocking lid• Ultra quiet• Fundamental safety and security

Class B vacuum steam steriliser• HTM 01-05 compliant• EN 13060 compliant• Rapid Vacuum / Standard cycles• Touch screen• Large 17 litre capacity / 22 litre

See Autoclave page for more in the range

UltrasonicsCompliance to “Best Practice” HTM 01-05 at the touch of a button

Patented Pulse 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

See the expert for advice or call our fully trained HTM 01-05 team +44 (0)1279 461641

SonoCheck

Valisafe CEI /Standard PCD Kit

SonoCheck MED1000.32 x30 £112.00 Test Foil MED1002 1 Roll £37.50

Valisafe CEI/Standard PCD Kit

V3502090(1 PCD & 10 CEI tests) £75.00

Replacement CEI V3502080 x50 £138.00

Test Foil

Ultrasonic cleaning is important to assist in the reprocessing of dental instruments, therefore the energy level and presence of cavitations in your Ultrasonic cleaner should be regularly monitored.

• A pre-prepared test showing immediate results• Colour change from green to yellow indicating a positive result• Easy evaluation

The foil test is the conventional method of measuring the ultrasonic activity over the whole of the tank; the activity of the Ultrasonic Clean-er is verified by the erosion pattern, which is created on aluminium foil exposed in the bath for a timed period.

20mm Width, 0.015m Gauge. 367m roll

The Standard PCD is a consistent reproducible way to monitor the cleaning efficiency of your Ultrasonic cleaner• Stainless steel tray for testing of Valisafe CEI (Cleaning Efficacy Indicator)• Conforms to ISO 15883• Easy to use - Easy to read

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Ultrasonics &Ultrasonic Cleaner Performance Monitoring

HTM 01-05Pg 60,14.4

HTM 01-05Pg 60,14.4

HTM 01-05Pg 60,14.4

OR

This is the Ultrasonic Activity Test

Can be used as a weekly test Conventional test, somewhat time consuming

This is a visual indicator that helps you to identify that the load has been properly cleaned and can be used as a daily check

This is the Cleaning Efficacy Test

ProTEST ‘Q’ V3503895 50 tests £215.00

Ready to use rapid protein residue detection system. Protein residue test in accordance with EN ISO 15883-1

• HTM 01-05 compliant• Results in 10 minutes• Biuret sensitivity• Ninhydrin safety• Pre moistened swab• Easy to use• 18 month shelf life

HTM 01-05Pg 60,14.4

Easy to use, this weekly test to confirms that the cleaning process retains the capability of removing protein

This is the Protein Residue Test

ProTEST Quick

&

Ezee Clip M20018 x1 (Size 10) £30.00 Eyeshields Pk MED100.83 x50 £64.00

Printer MED1014 x1 £335.00

Printer roll MED1014.1 x1 £7.80

Printer

Medi-Logger M20070 x1 £420.00

Medi-Logger

Keyboard M20205 x1 £45.00

Waterproof / AntibacterialKeyboards

PIP V3502140 x1 £26.00

PIP(Process Indicator Pen)

Ezee Clips

For monitoring and documenting all operational functions/parameters performed by the Pico washer disinfector range.

The Medi-logger record and stores all cycle in-formation on a MMC mobile memory card. Cycle information is stored in simple text files. These text files may be read and used in any standard Office applications once connected to a PC.

• Fully Waterproof: Circuit board & membrane are completely sealed allowing keyboard to be fully submersed & washed• USB-PS/2 combi keyboard• Plug & play set up • Compatible with Windows XP/2000/2003/ME/98/Vista

• Conforms to EN ISO 11140-1 (Class 1) • Universal application on all sterilization wrapping materials• Writes for over 400 M• Lead free• Cost effective process indicator system • Clear stop / Go colour change

• Instruments handling system• Available for all makes & models of cleaning & sterilising equipment• Protects both staff & instruments• Made from stainless steel & silicon for long life

• Prevents fogging & misting• Lightweight & comfortable• Protects against harmful debris & splashes• Optical grade lens

Decontamination Accessories

Go to www.medisafedirect.co.uk for more accessories

HTM 01-05 Pg 18, 3.19

HTM 01-05Pg 35, 6.27

HTM 01-05 Pg 18, 3.17

HTM 01-05Pg 18, 3.19

HTM 01-05Pg 39, 6.66

HTM 01-05 Pg 26, 4.24

OR

Eyeshields

Sign & date your pack instead of using autoclave tape

Use every cycle Use every cycle

Reduce Infectivity

3E-Zyme (non foaming) Medi-pH-Safe (aluminium friendly)

AWT (Automatic H20 Treatment) Foam Spray

3E-Zyme MED8035 x1 (4L) £59.50 Medi-pH-Safe M20011 1x 5L £71.50

AWT MED1000.09 6 x 0.5L £75.00

AWT M20059 4L £67.00 Foam Spray MED8050.1 1 x 500ml £14.00

• A bacteriostatic triple enzyme cleaner • Non foaming and PH neutral detergent • Three in one non-corrosive cleanser is safe & fast acting • As well as being used in your washer disinfector, this detergent can also be used as a pre-soak and also for ultrasonic cleaning. • Fully effective against proteins, lipids, carbohy-drates & mucopolysaccharides.

Scale Preventor & Water Conditioner• Neutralising hard water salts to prevent scale deposition within the machine and on cleaned and disinfected surgical instruments• Neutralising residues of alkaline cleaning agents on ophthalmic instruments

Instruments reprocessed as soon as possible after use may be more easily cleaned than those left for a number of hours. Where immediate reprocessing is not possible, Enzyme Foam Spray is intended to maintain a moist or humid environment to aid sub-sequent decontamination. pH Neutral – safe and effective for Stainless Steel, aluminium and brass instruments.

• A new and unique formulation which gives the cleaning benefits of an alkaline detergent with the protection offered by an enzymatic detergent• PH9 composition facilitates fast efficient cleaning at high temperatures. A non foaming detergent and lower dilution rate that is suitable for dental instruments.• Especially for use in hard water areas

Cleaning SolutionsSee the expert for advice or call our fully

trained HTM 01-05 team

See section 3.19 of the HTM 01-05 guidelines for best practice cleaning solutions

Use for your washer and ultrasonicHighly efficient aluminium cleaner safe for use with all dental instruments, but you must read the manufacturers IFU

Keep your instruments moist before reprocessed in your washerUse for the hard water areas, washers only!

Medisafe InternationalTwyford Road, Bishop’s Stortford,

He r t f o r d s h i r e CM23 3 L J , U . K .

www.medisafeinternat ional.com

E:info@medisafeinternational.com

T : + 4 4 ( 0 ) 1 2 7 9 4 6 1 6 4 1

F : + 4 4 ( 0 ) 1 2 7 9 4 6 1 6 4 3

alisafe®

Valisafe is a division of Medisafe UK Ltd

www.valisafe.com

Benchtop M20072 £325.00

Benchtop Package

Manifold M20162 £45.00

Benchtop Manifold Package

XL M20073 £838.00

XL Package

XXL M20074 £1,110.00

XXL Package

• 1 bottle of 3E-Zyme• 2 bottles AWT• 2 x 20 ezee clips• 4 x 10 ezee clips• 2 x 3 ezee clips• 1 burr baskets

• 8 Ezee clip cassette size 20 • 8 Ezee clip cassette size 10 • 4 Ezee clip cassette size 3 • “Toast Rack”• 2, 3 Ezyme detergent 4ltr bottle • AWT 4ltr Bottle • 1 Burr Basket x1

• 12 Ezee clip cassette size 20 • 8 Ezee clip cassette size 10 • “Toast Rack”• 2, 3 Ezyme detergent 4ltr Bottle • AWT 4ltr bottle • 2 Burr basket

Replacement Kit• 6 Rubber seals • 6 Blanking plugs • 6 Filters

Replacement Kits also available for the XL & XXL

HTM 01-05 Compliant Packages

Please ring on +44 (0)1279 461641Great Value