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HTM 01-05 for Dummies

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

Washer Disinfector & Washer Disinfector Performance Monitoring Sterilisers & Steriliser Monitoring Ultrasonics & Ultrasonic Cleaner Performance Monitoring Expert advise! Knowledge! Reference to the HTM 01-05 guidelines

Cleaning Solutions Decontamination Accessories


PICO

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

PICO Flush

PICO XL

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 XL slim under counter model allow 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 to maximum throughput, optimising efficiency. • Cleans up to 8 handpieces

PICO Plus Flush

MED-FP1159

PICO XL

MED1301

PICO Flush with drying

MED170

PICO XL with drying

MED1316

Decon Tower, Is space an issue?

PICO XXL

The 600mm wide under counter model allow 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 to maximum throughput, optimising efficiency. • Cleans up to 12 handpieces

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

PICO XXL

MED1300

Decon Tower - Stainless Steel

POA

PICO XXL with drying

MED1315

Decon Tower - Epoxy Coated White

POA


Washer Disinfector & Washer Disinfector Performance Monitoring HTM 01-05 Pg 58,13.4

TOSI

HTM 01-05 Pg 58,13.4

Standard PCD

Test 1

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

OR

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

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

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

• 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

Standard PCD

V3502090

x1

Tosi

£75.00

MED100.00

x12

£72.00

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

ProTEST

ProTEST Quick

HTM 01-05 Pg 58,13.4

HTM 01-05 Pg 58,13.4

OR

A weekly HTM 2030/ HTM 01-05 protein detection 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 residues down to 1μg sensitivity (equal to or greater than Ninhydrin) • Incubation is not required ProTEST

M20133

x50 tests

£147.50

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

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 ProTEST ‘Q’

V3503895

50 tests

£215.00

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

Test 2

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


Autoclaves

Compliance to “Best Practice” HTM 01-05 at the touch of a button Vacuum (Type B) Autoclaves

PICOclave 21ED 22 litre

Class B vacuum steam steriliser • HTM 01-05 compliant • EN 13060 compliant • Rapid Vacuum / Standard cycles • Touch screen • Large 22 litre capacity PICOclave 21ED 22L

MED1910

PICO clave 17ED 17 litre

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

MED1915

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

Non Vacuum (Type N) Autoclaves

PICOclave 21E - 22 litre

Class N steam steriliser • EN 13060 Compliant • Class N • Non-vacuum • Easy to operate • 22 litre capacity PICOclave 21E 22L

PICOclave 17E - 17 litre

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

MED1900

PICOclave 17E 17L

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

MED1920


Sterilisers &

Steriliser Monitoring This is the Daily Steam Penetration Test HTM 01-05 Pg 25,4.18

B&D Test Pack

HTM 01-05 Pg 25,4.18

EN867 Helix Device

Test 1

EN13060 Vacuum Autoclave compliant ONLY

OR 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.

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 V3501020

x20

£52.00

Helix

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

This is the Automatic Control Test

Class 6,

x250

£130.00

This is your daily Load Check

Dual Class 4 (Load Check)

HTM 01-05 Pg 56

3.5 min Indicator

V3502034

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

Test 2

B&D Test Pack

• 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 Class 6 chemical indicators offer the highest level of proof of the achievement of Sterility Assurance 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 Class 6, 3.5 min

V3502060

x250

£35.50

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

• 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 Class 4

V3502038

x500 (x2)

£35.50

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

www.valisafe.com


Ultrasonics

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

DentaSonic

Ultrasonic

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

PICO

Washer Disinfector

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

DentaSonic

MED1800

PICOClave

Machine types Ultrasonics Ultrasonics are used for cleaning instruments with hinges or intricate parts.

HTM 01-05 Pg 19, 3.21

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

HTM 01-05 Pg 17, 3.13

Autoclaves Autoclaves are used to sterilise instruments after they are thoroughly cleaned

HTM 01-05 Pg 22, 4.2

Autoclaves

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

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


Ultrasonics & Ultrasonic Cleaner Performance Monitoring

SonoCheck

HTM 01-05 Pg 60,14.4

Test Foil

HTM 01-05 Pg 60,14.4

Test 1

This is the Ultrasonic Activity Test

OR 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.

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

• A pre-prepared test showing immediate results • Colour change from green to yellow indicating a positive result • Easy evaluation MED1000.32

x30

£112.00

Test Foil

Can be used as a weekly test

MED1002

1 Roll

£37.50

Conventional test, somewhat time consuming

This is the Cleaning Efficacy Test

This is the Protein Residue Test

Valisafe CEI / Standard PCD Kit

ProTEST Quick

HTM 01-05 Pg 60,14.4

HTM 01-05 Pg 60,14.4

& The Standard PCD is a consistent reproducible way to monitor the cleaning efficiency of your Ultrasonic cleaner

£75.00

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

£138.00

ProTEST ‘Q’

• Stainless steel tray for testing of Valisafe CEI (Cleaning Efficacy Indicator) • Conforms to ISO 15883 • Easy to use - Easy to read Valisafe CEI/ Standard PCD Kit

(1 PCD & 10 CEI tests)

Replacement CEI

V3502080

V3502090

x50

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

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

V3503895

50 tests

£215.00

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

Test 2

SonoCheck

20mm Width, 0.015m Gauge. 367m roll


Decontamination Accessories

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

HTM 01-05 Pg 18, 3.17

Ezee Clips

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

M20018

x1 (Size 10)

HTM 01-05 Pg 35, 6.27

Eyeshields

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

Eyeshields Pk

£30.00

MED100.83

x50

£64.00

Reduce Infectivity

HTM 01-05 Pg 18, 3.19

Printer

HTM 01-05 Pg 18, 3.19

Medi-Logger

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

Printer

MED1014

x1

£335.00

Printer roll

MED1014.1

x1

£7.80

The Medi-logger record and stores all cycle information 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.

Medi-Logger

Waterproof / Antibacterial

HTM 01-05 Pg 39, 6.66

Keyboards

• 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

Keyboard

M20205

M20070

x1

£420.00

Use every cycle

Use every cycle

x1

£45.00

PIP

HTM 01-05 Pg 26, 4.24

(Process Indicator Pen)

• 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

PIP

V3502140

x1

£26.00

Sign & date your pack instead of using autoclave tape


See the expert for advice or call our fully trained HTM 01-05 team

Cleaning Solutions

3E-Zyme (non foaming)

Medi-pH-Safe (aluminium friendly)

• 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, carbohydrates & mucopolysaccharides.

• 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

3E-Zyme

Medi-pH-Safe

MED8035

x1 (4L)

£59.50

M20011

1x 5L

£71.50

Highly efficient aluminium cleaner safe for use with all dental instruments, but you must read the manufacturers IFU

Use for your washer and ultrasonic

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

AWT (Automatic H20 Treatment)

Foam Spray

Scale Preventor & Water Conditioner

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 subsequent decontamination. pH Neutral – safe and effective for Stainless Steel, aluminium and brass instruments.

• 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 AWT

MED1000.09

6 x 0.5L

£75.00

AWT

M20059

4L

£67.00

Use for the hard water areas, washers only!

Foam Spray

MED8050.1

1 x 500ml

£14.00

Keep your instruments moist before reprocessed in your washer


Please ring on +44 (0)1279 461641

Great Value

Benchtop Package

Benchtop Manifold 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

Benchtop

M20072

Replacement Kit • 6 Rubber seals • 6 Blanking plugs • 6 Filters Replacement Kits also available for the XL & XXL

£325.00

XL Package

Manifold

M20162

£45.00

XXL Package

• 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

XL

HTM 01-05 Compliant Packages

M20073

• 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

£838.00

XXL

M20074

£1,110.00

Medisafe Internation al Twyford Road, Bishop’s Stortford, Hertfordshire CM23 3L J, U.K. T:

+44

(0)1279

461641

F:

+44

(0)1279

461643

w w w. m e d i s a f e i n t e r n a t i o n a l . c o m E:info@medisafeinternational.com

alisafe

®

www.valisafe.com

Valisafe is a division of Medisafe UK Ltd

HTM 01-05 Leaflet  

Health Technical Memorandum 01-05: Decontamination in primary care dental practices

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