flashtite instructions for use copyright 2010 © case medical inc

15
FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc.

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Page 1: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FLASHTITE INSTRUCTIONS FOR USE

Copyright 2010 © Case Medical Inc.

Page 2: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

Innovative designer and manufacturer of high quality sterilization containers and instrument chemistries Sterilization containers validated

for all sterilization processes providing custom and modular options

Instrument chemistries composed of high levels of synergistic enzymes and chelating agents. Validated and environmentally friendly

New modern and integrated facility in South Hackensack, NJ All of our products are manufactured

under our roof in the USA. FDA Registered, ISO Certified,

WBE and Corporate Member of AAMI.

Case Medical

Page 3: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite, a filter-less flash container

A sealed container system for immediate use sterilization

Rapidly sterilizes instruments and medical devices in gravity displacement or pre-vacuum flash cycles

Sealed transport with virtually “dry” loads Simply place the instruments in the

FlashTite basket, seal, sterilize and transport sealed to point of use

Page 4: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite

Validated in independent laboratories utilizing the overkill principle for blades, lumens, mixed loads and 16 lbs.

of surgical devices. State of the art technology:

Replaces flashing with an open pan or using a sealed container in the lid open position.

Safe and effective: Valve automatically opens and closes in the

autoclave.

Page 5: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite, a filter-less flash container

Meeting all current requirements for safe and effective sterilization. Meets AAMI and AORN parameters for

closed flash sterilization Goes into the autoclave sealed and comes

out sterilized and sealed Cleared with FDA 510k Complies with JCAHO requirements for

sealed flash sterilization

Page 6: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite Decontamination

All flashed items must be cleaned and dried prior to use including container systems.

The FlashTite container system should be cleaned with a neutral pH detergent only.

Rinse thoroughly after each use . Dry all components.

Page 7: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite Decontamination

Set up SuperNova at the sink or a pH neutral detergent for manual cleaning and decontamination of items for immediate use, as well as the FlashTite container.

Always follow cleaning with a thorough rinse and dry.

Page 8: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite Instructions for Use

1. Place FlashTite valve plate over each perforated area in lid and/or base.

2. For gravity displacement steam, use only perforated bottom containers.

3. FlashTite basket should be utilized to hold surgical devices in place. It is designed to clear the vent in lid and base.

Page 9: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite Instructions for Use

As an alternative to the FlashTite basket, you may utilize our Flash Rack, if loaner/specialty trays are to be placed into the container.

The Flash Rack offsets the valve plate in the base.

Page 10: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite Instructions for Use

4. Attach red flash tamper evident seal with chemical indicator to tab on valve plate in lid. The chemical indicator will darken when processed. The arrow will deform.

5. Case Medical’s flash chemical indicators are recommended for use in all SteriTite containers with FlashTite valves.

6. Close the SteriTite container and sterilize. Valve will automatically open and close during the sterilization process.

Valve in Open Position

Valve in Closed Position

Page 11: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

Recommended Exposure & Dry Times

For Pre-vacuum Flash: Minimum exposure time of 3 minutes

for non-porous items, 4 minutes exposure for lumens and

mixed loads

For Gravity Displacement Flash: Minimum exposure time of

5 minutes for non-porous items and a minimum exposure time

of 10 minutes for instrument sets, lumens and mixed loads

Dry Time: 0-3 minute dry time in the autoclave for items

processed in flash sterilization depending on the degree of

dryness required

Page 12: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

FlashTite at Point of Use

Transfer container using a glove or dry towel.

Open container. Check seal on valve.

That valve has opened. That indicator turned That arrow deformed

Page 13: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

Flashing Rules of Thumb

Exposure and dry times may vary depending on size of load, type of device and condition of steam and sterilizer.

Start at the highest recommended exposure time (10 minutes in gravity) and reduce as needed.

No dry time is required, but 2 to 3 minutes will give you drier contents.

You may crack the door for gradual cool down. Do not use disposable filter with FlashTite valve.

Page 14: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

Always verify in your

hospital sterilizer. Check that the

correctcycle has been chosen That the

appropriatecontainer has been

selected(perforated bottom

container forgravity displacement

steam) Use rapid readout

BIsfor routine verification

andwhen implants areprocessed.

Verify

Page 15: FLASHTITE INSTRUCTIONS FOR USE Copyright 2010 © Case Medical Inc

Thank you

Remember: Flashed items are for immediate use only.