1

2

It is well established that decontaminating an SUD is economical and reduces waste.

circuitGuard™ has recently been cleared by the FDA as an alternative to that decontamination process.

“Indications: Protection of patients from excessive heat and moisture loss. Protection of patients and equipment from contamination".

3

“The FilterFlo™ Filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of the breathing system and / or breathing gas conveying parts of the ventilator.

The device is intended to protect patients and equipment from contamination.”

4

circuitGuardTM

ARC Medical, Inc. was started in 1990 to serve the humidification and filtration needs of ventilator dependent patients and surgery patients.

ARC Medical provides the highest performing devices for filtration and humidification based upon independent, 3rd party testing.

Our manufacturing utilizes state of the art engineering with automated assembly assuring consistently performing devices from one day to the next.

ARC Medical is committed to provide the Anesthesia Department and the Intensive Care Units with innovative and cost saving products -- while providing a protected environment for both the patient and the caregiver.

Patient charge

item

DRGs and Managed

Care

Anesthesia Providers

prefer lighter weight

They convinced hospitals

the product was

disposable …single use

No supporting studies show

dABC reduces potential for

cross-contamination

FDA regulations pertaining to SUD reprocessing do not apply to SUDs that are not reprocessed when there is protection from mucous membrane contact.

There are no guidelines or standards for protecting a disposable product from contamination.

Reprocessing standards do not apply if the device will not be sent for reprocessing.

There are no reported touch contamination incidents between the anesthesia provider and any equipment (knobs, flat and horizontal surfaces, CO2 lines, etc.).

We are a filter manufacturer and can not advocate changing the labeling on a circuit.

If you decide to use our filter to protect the equipment and patient from cross contamination, and a cross contamination occurs, the circuit is not at fault.

The type of circuit used is irrelevant.

Our filter products, used as recommended, would be responsible for the cross contamination.

“circuitGuardTM (Pharma Systems) has been used in over 56,000,000+ general anesthetic procedures in Europe, Asia, and North America.

There has never been a cross contamination reported to any regulatory agency in any country or directly to Pharma Systems”.

Curt Danielsson, Managing Director, Pharma Systems

“The protocol for use with our filter was single patient use of the filter with multiple patient use of the anesthesia breathing circuit.

Circuits were changed at varying intervals according to the hospital protocol”.

Curt Danielsson, Managing Director, Pharma Systems

circuitGuardTM Sales

2007 - 2010

10 Ways to Save on Supply Costs

“If you know where to look, you can

find big money hiding out on the

shelves in your supply room”.

Otto Griffin, VP, Materials

Management, Symbion Healthcare

“Use a circuit guard on breathing

circuits. Start using a breathing circuit

protection unit. This FDA-approved

device prevents cross-contamination

and lets you reuse a breathing circuit

all day, instead of throwing it away

after each case.

It saves you between $4 and $6 per

case. It also reduces the amount of

medical waste you produce each

Day”.

May 2008

“FOR THE RECORD

Re: ’10 Ways to Save on Supply

Costs’ (May, page 42). We’ve received

several inquires for more information

about circuitGuard, an anesthesia

breathing circuit protection unit.

This FDA-approved filter device

prevents cross-contamination and lets

you reuse a circuit throughout the day.

These disposable devices cost $1.85

each for the standard model and $2.85

for a version with a HME humidifier.

They’re sold be the case of 100 by

ARC Medical, of Tucker Ga. Learn

more at www.arcmedical.com or by

calling (800) 950-2720, ext 272”.

July 2008

“ARC Medical

circuitGuardTM

(800) 950-2721

List price: $1.85 to $2.85 each, in

cases of 100

These disposable filters let you use a

single anesthesia circuit for a day’s

worth of cases. That’s a money-saving

idea.

The circuitGuard’s integrated CO2 port

seems like it would help prevent cross-

contamination. Its compact design and

low profile are suitable for both

pediatric and adult patients.”

July 2008

18

19

Patient Elbow HCH Media ETCO2 Port

Ridge & Lip Construction Circuit Connection

The circuitGuardTM

System

21

22

The circuitGuard filter allows the hospital to protect the patient from contamination from the gas machine and to protect the gas machine from contamination from the patient.

Our construction eliminates the possibility of gases bypassing filter media because of the creation of two inner walls which are created during the manufacturing process.

“Unitized Construction” of circuitGuard(the only product on the market with this type of construction) ensures integrity of the filter media.

We have an exclusive advantage in manufacturing. Our engineers assemble our devices so that the top and bottom halves of the device will not fit together unless the filter is properly seated.

Other manufactures depend upon glue or ultrasonic welding to accomplish this –possible fail points.

Housing construction ensures filter media placement and seal.

No “blow-by” of gas is possible. All of the gas is directed to go through the hydrophobic filter media, it can not go around it due to its unique construction.

Bi-directional filtration at the breathing circuit’s wye protects the patient from the gas machine and protects the gas machine from the patient.

Our independent cross-contamination study shows 100% efficiency against cross

contamination.

circuitGuard with HME

combo

circuitGuard filter only

combo

Independent testing is available from:

The 3M Company

Nelson Labs

CAMR – the Center for Applied Microbiology and Research located in Porton Down, England.

CAMR, is one of the largest independent microbiology laboratories in the world. They are also associated with the International Standard Organization (ISO).

Fewer anesthesia circuits are used.

Fewer ETCO2 gas sample lines used.

Eliminates the need for additional filters.

Eliminates the need for additional HMEs.

Reduces shipping and inventory costs.

Decreases OR turnover times.

Upwards of $120.00 per minute room costs

Dry, filtered gas sample line protects the ETCO2 monitor from contamination and down time.

Dry, filtered gas sample lines reduce the replacement of costly water traps and repair costs due to moisture problems.

Reduces environmental stress:

– an estimated 12 million circuits are disposed of each year.

32

Or do they white bag their circuits…

3M Filtration Products Division approach to air filtration is simple: efficient particle removal without sacrificing airflow rate.

This approach has yielded a line of highly efficient, low-pressure drop air filtration media and filters.

The result is a filter that demonstrates high efficiency against difficult-to-capture sub-micron particles.

Straining:

Large particles are too large to pass between the fibers of the filter media.

Sieving:

Large particles are too large to pass between the fibers of the filter media.

Inertial Impaction:

Larger particles collide with the filter fibers. Because of the high inertia, they cannot follow the air stream as it moves around the fibers.

Watch out for that tree!

Brownian Diffusion:

Particles smaller than 0.1 micron are carried by the motion of the air molecules, causing the particles to randomly come into contact with the filter fibers.

Electrostatic Enhancement:

Fibers are given permanent electrical charges to attract particles in their vicinity, which greatly increases the “electret” filter’s ability to capture small or medium-sized particles.

ARC has large shipping units per case – less freight

charges.

One dABC box will hold 800

circuitGuards.

ARC currently sells over 450 facilities on

a monthly basis. Since 1990, we have had NO back orders.

circuitGuard with HME combo circuitGuard filter only combo

Discussion…

circuitGuard™ is a bi-directional filter.

It protects your patient from contaminating the circuit and machine as well as protecting the patient from contamination by the circuit and machine.

You can choose to use any circuit of your choice.

42

We are a filter manufacturer and can not advocate changing the labeling on a circuit. If you decide to use our filter to protect the equipment and patient from cross contamination, and a cross contamination occurs, the circuit is not at fault.

The type of circuit used is irrelevant. Our filter products, used as recommended, would be responsible for the cross contamination.

43

It is not unlawful to reuse single use devices (SUDs); however, hospitals and third parties that reprocess single use devices must comply with the laws administered by the FDA.

Anesthesia Breathing Circuits are identified as “semi-critical” risk when reprocessed, because of their contact with intact mucous membranes.

44

If there is protection from patient mucous membrane contact then the product does not need to be reprocessed.

FDA regulations pertaining to SUD reprocessing do not apply to SUDs that are not reprocessed when there is protection from mucous membrane contact.

45