Medisafe – Sterility Assurance Products...Medisafe – Sterility Assurance Products PCD Starter...

Medisafe – Sterility Assurance Products

Index

Medisafe – Sterility Assurance Products 3 3 Sterility Assurance Products - Cleaning 5 Sterility Assurance Products - Sterilization 7 Steam Sterilizing Monitoring 9 Hoses and Luers - Machine Accessories 13 Machine Accessories 17 Accessories/Dedicated Consumables


PCD Starter Kit

Description

The Standard 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

This is a visual indicator that helps you to identify that the load has been cleaned efficiently and can be used as a daily test as advised by HTM 01-01 or weekly/quarterly check. We use materials to closely replicate your dirty instruments using real blood and additives layered onto a stainless steel plate. Therefore recreating your dirty instrument.

Order Code Description

M20230PCD Starter Kit (1 x PCD & 12 x CEI)

Please note alternative sizes may exist. Please check selected product availability for your region.


V3502105 1 PCD for MIS HP


PCD for MIS HP

Description

Process Challenge Device for MIS instruments to be used in conjunction with Valisafe CEI for High Pressured washer disinfectors and ultrasonic cleaners. Test your machine’s High Pressure (HP) lumen cleaning performance – the MIS HP is suitable for 0.4 to 4 bar pressure.

• For monitoring the cleaning efficiency of Washer-Disinfectors/Sonic Irrigators, or MIS or other lumen devices.

• Simulates cannulated instruments for MIS • Easy to use – easy to read

CEI (Cleaning Efficacy Indicator)

Description

Real blood test soil for use with Process Challenge Devices. CEI is designed for the validation and routine monitoring of the cleaning process for Washer-Disinfectors/Ultrasonic Cleaners. Complies to ISO 15883 Part 5.

Order Code Quantity

V3502080 50/Pack


cleaning


V35020901 PCD for Sonic Irrigator MP


PCD for Sonic Irrigator MP

Description

The New PCD has a transparent viewing chamber to easily read the results.

• Monitors the cleaning efficacy of low/ medium pressure sonic irrigators

• Simulates lumen instruments• Conforms to ISO 15883• Easy to use – Easy to read• Non-toxic

3


Fine Lumen Check - FLC1 1 mm / FLC2 2 mm & Endocheck

Description

Process Challenge Device specifically designed to test your machine’s lumen cleaning performance to be used in conjunction with Valisafe CEI for high pressure AER. Ingeniously designed to represent a difficult cleaning challenge.

Order Code Description Quantity

V3502120 FLC1 1 PCD

V3502130 FLC2 1 PCD

V3502150 Endocheck 1 PCD


Brilliant Blue Distal Check

Description

Brilliant Blue Distal Check detects protein residues left behind on complex surgical instrument tips. Simply immerse the tip of your complex surgical instrument in the solution contained within the distal holder, by inserting the tip and leave for 5 seconds. If protein is present, the reagent will turn from brown to blue within 10 seconds. Protein detection range 5 to 40 μg.


MED7910 BB Distal-Check 25 Vials


Scope-Check/Instru-Check

Description

The Scope-Check/Instru-Check protein test is a rapid test that has the ability to detect residual proteins left behind on the surfaces of washer disinfectors, ultrasonic cleaners, endoscopes and other hard to clean surgical instruments. This protein test is based on a dye-binding solution used in clinical chemistry and can detect protein residues within 1 µg sensitivity.

• Conforms to BS EN ISO 15883• Result within 10 seconds• Easy to use - no incubation required• Clear colour change• Cost effective• For use with: Endoscopes, WD/Ultrasonic surfaces &

Surgical instruments


V3504095

Scope-Check/Instru-Check Standard Kit

25 Vials & 25 x Standard Swabs

V3505005 Scope-Check 2.8 mm

25 Vials & 25 x 2.8 mm Swabs

V3505010 Scope-check 1.9 mm


V3505013 Scope-Check 3.7 mm



cleaning

4

3 Line Duplex Label & Gun

Description

This simple to use indicator label for steam sterilization processes creates a direct link between the process and the patient. Compatible with all manual traceability systems, it is very suitable to hospital, clinic, GP departments and for both large and table top sterilizers. Used in conjunction with the 3 Line Label Gun, the information about the pack can be printed by the gun or hand written during the preparation process.

• Label conforms to EN IS0 11140-1 Type 1• Adhesive indicator for record keeping• Steam Indicators • Records; process date, expiry date, operator number,

steriliser number and cycle number• Non toxic & lead free


V3504054 3 Line Duplex Labels30 Rolls of 500 Labels

V3504060 3 Line Label Gun 1 Unit

V3505055 Ink Cartridge 1 Unit


Autoclave Tape

Description

Valisafe’s Autoclave Tape for steam sterilization enables the user to see at a glance that an item has been processed. The easy-to-interpret black stripes prove that the pack has been exposed to the steam sterilization process.

The tape is made from good quality masking paper which is lead free, with colour-changing water-based ink, made with acrylic pressure-sensitive adhesive and is individually packed.

Shelf Life: 2 years


V3504040 Autoclave Tape 19 mm 72 Rolls



sterilization

Shelf Life: 3 years

Daily Bowie and Dick Test Pack - StandardColour change: pink to brown or darker Description

Use this test at the beginning of each working shift in every pre-vacuum B.1 assisted steam sterilizer to ensure rapid and even steam penetration into a small porous load. This non-toxic test is not a test of sterility but a test of the mechanical function of the sterilizer to ensure rapid and even steam penetration into a small porous load. The Valisafe B&D test pack fulfils the requirements of both EN 285 and EN ISO 17665.

134 °C-137 °C3-3.5min


V3501020 B&D Daily Test Pack (Standard) 20/Box


5

Daily Bowie and Dick Test Sheet

Shelf Life: 3 years

Colour change: yellow to blue

Description

Incorporated into the original Bowie and Dick Towel Pack at the beginning of each working shift in every vacuum assisted steam sterilizer to ensure rapid and even steam penetration into a small porous load. The Valisafe B&D test sheet offers an economical yet accurate way of ensuring the sterilizer is functioning correctly at the beginning of each working day.

134 °C-137 °C121 °C-124 °C


V3501210 B&D Test Sheet 50/Box


2-10min8-30min

Type 4 Dual Multi Parameter Indicator

Description

The Valisafe Type 4 Dual Multi-Paramter indicators offer an economical, yet effective, way of monitoring your steam sterilization processes. With one accurate calibration worldwide it is a secure and safe monitoring system yet simple and easy to use. Unlike most other Type 4 indicators available today the Valisafe indicator is non toxic - another sign of its advanced technology.

Shelf Life: 3 years


V3502038

Type 4 Dual Multi Parameter Indicator

250 Indicators split to 500


121 °C-134 °C3-3.5min


V3504065 Type 6 Indicators (3.5 min at 134 °C) 200/Pack

V3504068Type 6 Indicators (5.3 min at 134 °C or 15min at 121 ˚C)

200/Pack


121 °C-134 °C3-3.5min

Colour change: Original to dark grey or black

Self-adhesive Type 6 Indicator

Description

The Valisafe Type 6 self adhesive chemical indicators offer the highest level of proof of the achievement of sterility assurance levels in your trays and items. These indicators are calibrated specifically to your cycle requirements. The indicators offer validated security that every tray or item has been effectively processed, thereby providing a direct link between the sterility of the items and the patient. Self adhesive to provide ease of use in any document or traceability system.

Shelf Life: 3 years


Daily Bowie and Dick Test PackColour change: yellow to blue

Description

Use this test at the beginning of each working shift in every vacuum assisted steam sterilizer to ensure rapid and even steam penetration into a small porous load. This lead-free test consists of a number of specially selected sheets of barrier material and a chemical indicator sheet, which is wrapped in steam sterilizable paper. The Valisafe B&D test pack fulfils the requirements of both EN 285 and EN ISO 17665.


V3501024 B&D Daily Test Pack 20/Box


Before Unexposed Test Pack Indicator

Back of Indicator

Shelf Life: 3 years

134 °C-137 °C3.5min


6

Medisafe – Steam Sterilizing Monitoring

Type 6 IndicatorDescription

The Valisafe Type 6 Indicators are designed to monitor the efficacy of steam sterilizer cycles. They offer the highest level of proof of the achievement of Sterility Assurance Levels in your trays and items. These indicators are calibrated specifically to your cycle requirements. Valisafe Type 6 indicators offer validated security that every tray or item has been effectively processed, thereby providing a direct link between the sterility of the items and the patient.

• Conforms to EN ISO 11140-1 Type 6 • Type 6 cycle verification indicator • Monitors critical parameters

- Time - Temperature - Steam

• Clear and abrupt colour change • Easy to interpret - easy to record




V3502065Type 6 Indicators (5.3 min at 134 °C or 15 min at 121 °C)

200/Pack

V3502070Type 6 Indicators (7.0 min at 134 °C or 20 min at 121 °C)

200/Pack


134 °C-121 °C

3.5 min4.0 min 5.3 / 15 min 7.0 / 20 min


Description

Ensure that your VHP sterilization process was effective. The Valisafe VHP (Plasma) process indicator is designed for use in a VHP sterilizer. The indicator will exhibit a clear colour change when exposed to hydrogen peroxide during the diffusion stage of the process. When utilised properly, the VHP indicator will give clear visual confirmation that the item was exposed to hydrogen peroxide.

AfterAfter total process

BeforeOriginal indicator


V3503970 Plasma Indicator 200 Indicators


Colour change: magenta to yellow

Plasma Indicator

Loadcheck

Description

The Valisafe Loadcheck is designed to be used in conjunction with the Valisafe in pack monitoring systems. Placed in the chamber with the load and read on completion of the cycle it provides immediate physical independent confirmation that the cycle parameters have been met in the chamber - for confident release of the load.


V3502030 3.5 min at 134 °C Loadcheck

V3503917 4 min at 134 °C / 12 min at 121 °C Loadcheck

V3503910 5.3 min at 134 °C / 15 min at 121 °C Loadcheck

V3503920 7.0 min at 134 °C / 20 min at 121 °C Loadcheck


134 °C-121 °C

3.5min4.0min 5.3 / 15min 7.0 / 20min

Colour change: pink to brown or darker

EN 867 Part 5 Helix Device

Colour change: blue to black

Use in conjunction with your in-pack monitoring systems and read on completion of the cycle to ensure that your Type B table top sterilizer is performing correctly. This device, therefore has the capability to provide you with effectively sterilized items in your practice. Used in conjunction with the Valisafe indicators you can be sure sterility assurance levels have been met.


V3502034 Helix Device 250 Indicators


134 °C3.5min

7

Ultrasonic Foil TestDescription

The Foil Test is designed to show the operating cycle of an ultrasonic functions correctly when instruments are being processed, no matter where they are placed within the tank.

The ultrasonic activity can be investigated by the erosion pattern created on the aluminium foil exposed in the tank for a short period.

• Ideal width for performing the foil test• High quality foil, does not perish

Order Code Description Size

MED1002 Foil test 411 m Roll


Seal CheckDescription

Routine monitoring of a heat sealing device to ensure optimum sealing seams are achieved for packaging of instruments. The Valisafe Seal Check is for use as a routine monitor of a sealing device, and for operational qualification within the framework of process validation in accordance with EN ISO 11607-2 2006.

• Routine monitor for sealing device• In accordance with EN ISO 11607-2 2006 • Records sealing time, temperature and pressure • Cost effective • Easy to interpret

ValiSpore Biological Indicators and Incubator

Description

Steam & EO Biological Indcators to be used in conjunction with Valispore Incubator V3504035. Valispore Biological Indcators for Steam and Ethylene Oxide contain a known quantity of bacterial spores inoculated onto filter paper & placed inside a plastic culture, with a crushable glass ampoule containing the culture medium (traceable to a recognisable culture identified in USP and ISO 11138).

• Conforms to ISO 11138 • Easy to incubate – no laboratory conditions

for culturing • Dramatic colour change for positive cultures • Results in 24 hours for steam and 48 hours

for Ethylene Oxide • Non toxic


V3504000 ValiSpore Steam 10 x 5

100 Indicators

V3504005 ValiSpore Steam 10 x 6

100 Indicators

V3504010 Valispore EO 100 Indicators

V3504035 ValiSpore Incubator 1 Unit



V3505030 Seal Check 250 Indicators


Medisafe – Steam Sterilizing Monitoring

8

Medisafe – Hoses & Luers – Machine Accessories

SI SA / SI SA ‘S’ & SI Digital PC+ Hose & Luer

Description

• This hose is for use in the Medisafe SI SA / ‘S’ and SI Digital PC+ washers only

• The luer lock is compatible with many instruments and Medisafe’s Distal Connectors


MP22203

Complete Standard Hose and Luer Pack of 6 SI SA / SI SA ‘S’ / SI Digital PC+

6/Pack


MP22202

da Vinci Si Stapler Flush Adaptor

da Vinci Si Multi Complete Hose & Luer pack SI PCF / SI PCF ‘S’

Description

• This hose is for use in the Medisafe SI PCF only • This hose is for use with ISI da Vinci instruments only • The slip luer is compatible with the da Vinci S,

SS & Si instruments only


MP22202

da Vinci Si Multi Complete Hose & Luer pack SI PCF/SI PCF ‘S’

Single


Standard Hose & Luer Pack of 20 SI PCF / SI PCF ‘S’

Description

• This hose is for use in the Medisafe SI PCF / SI PCF ‘S’ washers

• The luer lock is compatible with many instruments and Medisafe’s Distal Connectors


MP22183Standard Hose & Luer Pack of 20 SI PCF / SI PCF ‘S

20/Pack


da Vinci Si Single Site Hose and Luer

Y-Connector Hose & Luer Pack of 20 SI PCF / SI PCF ‘S’ Order Code Description Quantity

MP22199Y-Connector Hose & Luer Pack of 20 SI PCF / SI PCF ‘S’

20/Pack


Description

• The Y connector for the SI PCF / SI PCF ‘S’ will double the number of instruments that can be reprocessed at one time.

9


da Vinci Xi Complete Hose & Luer Pack of 6 SI PCF/ SI PCF ‘S’

Description

• This hose is for use in the Medisafe SI PCF only • This hose is for use with ISI da Vinci instruments only • The luer is compatible with the da Vinci Xi

instruments only


MP21152

da Vinci Xi Complete Hose and Luer Pack of 6 SI PCF/SI PCF ‘S’

6/Pack


Complete Standard Hose & Luer Pack of 20 PCF PRO

Description

• This hose is for use in the Medisafe PCF Pro only • Can connect different instrument types/sizes


MP21846Complete Standard Hose & Luer Pack of 20 PCF PRO

20/Pack


da Vinci Xi Complete Hose and Luer Pack of 6 PCF PRO

Description

• This hose is for use in the Medisafe PCF Pro only • Can connect Xi EndoWrists & Xi Staplers


MP22018da Vinci Xi Complete Hose and Luer Pack of 6 PCF PRO

6/Pack


da Vinci Si Multi Complete Hose, Luers & Nozzles Set PCF PRO

Description

• This hose is for use in the Medisafe PCF Pro only

• Can connect Si instruments & Si Staplers


MP22168

1 replacement set of the daVinci Multi complete hose, Luer & Nozzles

1 Set


da Vinci Si Multi Nozzles Set

10


Complete Standard Hose & Luer Pack of 12 Niagara

Description

• This hose is for use in the Medisafe Niagara washers• The luer lock is compatible with many instruments and

Medisafe’s Distal Connectors


MP22222Complete Standard Hose & Luer Pack of 12 Niagara

12/Pack


Complete Flush Accessories & Hose Set Niagara

Description

• This hose is for use in the Niagara 1.5 Din basket• Can connect different instrument types / sizes


MP22243

1 replacement set of flush accessories & hose set for MED1425

1 Set


da Vinci Si Complete Hose & Luer Pack of 5 Niagara

Description

• This hose easily connects to da Vinci Si EndoWrist® instruments


MP22212da Vinci Si Complete Hose & Luer Pack of 5 Niagara

5/Pack


da Vinci Si Stapler Complete Hose & Luer pack Niagara

Description

• This hose easily connects to da Vinci Si EndoWrist® instruments

• This hose is for use in all Medisafe Niagara’s


MP22216da Vinci Si Complete Hose & Luer Pack of 5 Niagara

5/Pack


da Vinci Si Hose & Luer

11


da Vinci Xi Complete Hose & Luer Pack of 5 Niagara

Description

• This hose is used with da Vinci Xi Basket for Xi standard and stapler instruments


MP21133da Vinci Xi Complete Hose and Luer Pack of 5 Niagara

5/Pack


da Vinci Xi 8mm Complete Hose & Luer Pack of 5 Niagara

Description

• This hose is used with da Vinci Xi 8mm Basket for Xi Standard Instruments


MP20966.5

da Vinci Xi 8mm Complete Hose and Luer Pack of 5 Niagara

5/Pack


da Vinci Xi Stapler Complete Hose & Luer Pack of 2 Niagara

Description

• This hose is used with da Vinci Xi Stapler Basket


MP22217

da Vinci Xi Stapler Complete Hose & Luer Pack of 2 Niagara

2/Pack


12

Optho

Description

The ICTMIMS Care System is designed to protect your instruments throughout the reprocessing cycle until “point of use”. After usage the instruments can be returned again to the Care System to minimise potential damage to instruments during transit. Washing, disinfection and sterilization efficiency is improved over conventional trays and baskets with large open areas for greater efficiencies during the wash process and disinfection cycles.


MED9000Optho Standard (Without flushing accessory)

MED9011Optho Single (With single 7 port flushing accessory)

MED9012Optho Double (With double 7 port flushing accessory)


Height: Depth: Width:

1.7” 6.3” 10.2”

Full Size ICTMIMS Clam Shell

Description

Comes with millipede and pressure ball mouldings as shown. Add optional Flushing Manifold - MED9007


1.7” 18.9” 9.8”


MED9004 Full size


Half Size ICTMIMS Clam Shell

Description

Comes with millipede and pressure ball mouldings as shown. Add optional Flushing Manifold - MED9007


1.7” 9.4” 9.8”


MED9003 Half size


Medisafe – Machine Accessories

13

Millipede Moulding Replacement

Description

Supplied as shown


MED8162 Millipede Moulding



MED8163 Single ball strip

MED8159 Double ball strip


Description

• Single Ball Strip - 9 inches length (3.28 ft)• Double Ball Strip - 39 inches length (3.28 ft)

Single/Double Pressure Ball Strip Replacement

Flow Closing/Blanking Plugs

Description

Supplied complete with silicone and hose and connection. For use with MED9003 & MED9004


MED9014 Blanking Plugs


Plumbing Kit

Description

Standard phaco plumbing kit., Supplied complete with components shown. For use with all Optho Half & Full sizes.


MED9013 Phaco plumbing kit


Flushing Manifold

Description

Supplied complete with silicone and hose and connection. For use with MED9003 & MED9004


MED9007 Flushing manifold


Medisafe – Machine Accessories

14

Distal Connectors

Small Distal Connectors

Artemis Inspection Lamp

Description

Refer to HTM 01-05 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”. Compact free standing mains powered with LED lights for longevity.

Order Code

M20548


Description

Easy connection of lumen instruments that do not have a luer lock/slip luer port – suitable for use with all SI Series machines.

Description

Small Distal Connectors allows you to connect fine, delicate complex or non-ported instruments to a flush system to allow irrigation of the internal parts. Suitable for use with all SI Series machines.


MED1246.1.0 Red - 1 mm 10/Pack

MED1246.3.0 Blue - 5 mm 10/Pack

MED1246.2.0 Yellow - 8 mm 10/Pack

MED1246.4.0 Green - 12 mm 10/Pack



MED5003 Red - 1 mm 10/Pack

MED5013 Blue - 5 mm 10/Pack

MED5023 Yellow - 8 mm 10/Pack

MED5043 Assorted 10/Pack


Medisafe – Accessories

ID Security Tags

Description

Easy identification tags for instruments. Printed ID Tags allow you to quickly identify the action needed for that tray.

Length: Width: USM:

138 cm 70 cm 100


MED100.06 Blue (Sharpen) 100

MED100.07 Red (Repair) 100


15

Order Code

M20547


Order Code

M20546


Order Code

MED8106


Medisafe – Accessories

“Easy Clean” Mouse

“Easy Clean” Keyboard

Bur Basket

Description

Use to reprocess delicate dental hand piece burrs and ensure they are not lost or damaged.

Description

Our fully submersible ‘Easy Clean’ Mouse is also dishwasher safe, helping you to comply with HTM 01-05 guidelines. It contains a silver seal technology which protects the mouse between washing. With 24K gold-plated USB connector to prevent corrosion and is manufactured to IP-68 standards.

Description

Our waterproof ‘Easy Clean’ Keyboard is medical grade and dishwasher safe, used by healthcare professionals worldwide.

• Keys laser-etched to prevent fading • 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


V3502140 Process Indicator Pen 1 Pen


Process Indicator Pen

Description

Process Indicator Pen for use on all wrapping materials to indicate items that have been exposed to the steam sterilization process. Record additional critical data. Universally applicable the PIP can indicate your specific information requirements, such as surgeon’s/patient’s name, tray name or any other information required through your protocols.

16

LoadSafeOrder Code Quantity

M20316 1 Mat


Description

Prevent wrapping and packing from tearing and ensure that your packaged instrument baskets and wire trays remain in place throughout your entire process.

• Non-slip properties • Complies with European Directive 2002/72/EC • Resistant to chemicals and bacteria wear • Temperature resistant from -40 °C to 200 °C • 3 mm thickness • Suitable for use with washer-disinfectors & autoclaves

Annual Log Books

Description

HTM 01-05 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.


M20527 Washers Log Book

M20526 Autoclaves Log Book

M20524 Ultrasonics Log Book


Medisafe – Accessories/Dedicated Consumables

Order Code Quantity

MED1014.1 1 Roll


Printer Rolls

Description

High quality coated thermal printer paper is especially used in our Medi-Printer.

• Printer durability - 5 years • Coated with colour developing thermosensitive formulation• 112 mm x 48 mm (25”)• Non toxic

Order Code Quantity

MED3080 100/Pack


Disposable Filters

Description

Filters to keep Medisafe equipment in efficient working order. Change filters at every water change to keep Medisafe equipment in efficient working order. Available in packs of 24 or 100. For use with SI Digital SI Auto SI Digital PC+ SI SA and Reliance Digital/PC+ ranges.

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STERIS OFFICES WORLDWIDE

Benelux +32 (0)3 304 95 44Canada +1 (0)905 677 0863China +86 (0)21 6137 1166France +33 (0)5 5693 9494Germany +49 (0)221 4661 2030India +91 (0)22 6278 4100 Italy +39 (0)02 213 0341

Document no. ST11301EN, 2018-03, Rev.A, Instrument Reprocessing Consumables.

Japan +81 (0)3 5210 1521Latin America +55 (0)11 3372 9499Malaysia +60 (0)3 7954 9822Singapore +65 (0)6841 7677Spain +34 (0)91 658 5920Switzerland +41 (0)32 376 0200United Kingdom +44 (0)116 274 0600

©2018 STERIS Corporation. All rights reserved.

Medisafe UK Ltd Twyford Road, Bishop’s Stortford, Hertfordshire CM23 3LJ, United KingdomTel: +44 (0)1279 461641 Fax: +44 (0)1279 461643

STERIS CorporationChancery HouseRayns WayLeicester LE7 1PF United KingdomTel: +44 (0)116 274 [email protected]

Customer Operations [email protected] Tel: + 33 (0)5 56 939560

Medisafe – Sterility Assurance Products...Medisafe – Sterility Assurance Products PCD Starter...

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