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ARC Medical, Inc.


                7
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.




                                               8
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.


                                               9
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   There is a potential risk of bacterial and viral infection
    being transmitted through anaesthesia circuits.
   Several studies have shown contamination of parts of
    anaesthetic equipment with bacteria that colonize the
    mouth and upper airway.
   Among the recommendations for preventing
    transmission of infection through anaesthetic circuits are
    using a bacterial/viral filter for every patient or using
    disposable circuits.

                          Assoc Physicians India (2001) 49: 454-8.

                                                                  11
   Study Objective:
     Although there is no clinical evidence for using one
      alternative anesthetic device over another, we have
      introduced the systematic use of filters with patients
      undergoing general anesthesia.
     We describe the features of filters available on the
      market and our protocol for their use.




                                                               12
   Conclusion:
       The ideal filter is hydrophobic and does not increase
        circuit resistance over the amount specified with the
        following four principles:

        1.The filter forms a part of the patient, not the apparatus.
        2.Proper placement of the filter is between the patient and




                                                                       13
   Conclusion:

      3. The main purpose of the filter is to prevent
         contamination of the apparatus.
      4. If a hydrophobic filter is used with each patient, the use
         of a disposable respiratory circuit is not called for.

                Rev Esp Anestesiol Reanim 1994 Nov-Dec; 41 (6): 322-7




                                                                     14
   It would appear that the ISO standard only
    applies to dry heat and moisture exchange filters.

       Anaesthesia, July 2010 Volume 65 670-673




                                                         15
   STUDY OBJECTIVE:
     To investigate bacterial contamination of anaesthetic
      breathing circuits and means of prevention.
   CONCLUSION:
     The presence of a HMEF provides protection of the
      anaesthetic circuit as well as other patients, healthcare
      workers and the environment.

                        J Hosp Infect 1992 May; 21 (1): 51-60


                                                                  16
17
Particulate inclusions, drawn to scale,
            that may be found in a carrier gas.




©2001 by American College of Chest Physicians; Demers R Chest 2001;120:1377-1389
   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.


                                                         19
   More loading surface
   Highest charge/density available
   Lifetime charge in fiber
   Each fiber has both positive and negative charge --
    bipolar charges




                                                          20
The most basic form of filtration, the particle is larger than the space
between two fibers, and so, cannot follow the airstream through and is
captured.


                                                                           21
Diffusion occurs specifically with very small particles which follow
irregular patterns, in a manner similar to gases, and not necessarily
following the airstream. This irregular pattern is known as Brownian
motion and increases the particles chance of capture through contact with
the fibers.
                                                                            22
The mechanism by which large, high density particles are captured is called
impingement. As the particulate laden air passes through the filter media,
the air tends to pass around the fibers. Inertia of the particulate causes it to
separate from the airstream to collide with the fibers to which they become
attached.
                                                                              23
Interception occurs when a particle follows the airstream but still attaches
itself to the fiber as it passes around it. This is due to the electrostatic force
attracting the particle towards the fiber where it is retained.


                                                                                 24
25
26
   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.



                                                     27
   We have an exclusive advantage in our manufacturing
    process. This process is designed so that the top and
    bottom halves of the device will not fit together unless
    the filter is properly seated, thus providing 100%
    inspection for seal and blow by.
   Other manufactures depend on glue or ultrasonic
    welding to seal their halves together.
   circuitGuard ™ is built without fail points -- meaning
    no glue or ultrasonic welding is used, only a
    compression fit.



                                                               28
29
   “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.

                                                         30
   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.

                                                  31
   Many choose to reuse their anesthesia circuits




                                                     32
ARC Medical
    Inc       33
    Member
34
   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". 


                                                      35
    “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.”



                                                         36
   “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




                                                                  37
   “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




                                                                  38
circuitGuardTM Sales

    2009 - 2012




                       39
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
                                                       40
“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
                                                      41
“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
                                                      42
   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.



                                                        43
   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.

                                                     44
   There are no reported touch contamination
    incidents between the anesthesia provider
    and any equipment (knobs, flat and
    horizontal surfaces, CO2 lines, etc.).




                                                45
The circuitGuardTM System

Patient Elbow              HCH Media        ETCO2 Port




Ridge & Lip Construction               Circuit Connection
                                                         46
47
48
Our independent cross-contamination study
        shows 100% efficiency against cross
                 contamination.




circuitGuard ™ with HME combo   circuitGuard ™ filter only
                                         combo
                                                             49
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).



                                                       50
   Fewer products used




                          51
   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




                                                                 52
   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.




                                                   53
   Reduces environmental stress:
      An estimated 12 million circuits are disposed of
      each year.




                                                         54
Or white bag their circuits which means the
 circuits are considered not contaminated.


                                              55
Reduces inventory and storage costs




                                      56
circuitGuard ™ with HME combo   circuitGuard ™ filter only combo




                                                                   57
58
Discussion…




              59
   Yes, we have FDA labeling approval.
   “Indications: Protection of patients from excessive heat
    and moisture loss. Protection of patients and equipment
    from contamination. 
   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.

                                                                60
   circuitGuard™ is a hydrophobic, 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.




                                                              61
   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.


                                                           62
   It is not unlawful to reuse single use devices
    (SUDs); however, hospitals and third parties that
    reprocess single use devices must comply with the
    reprocessing laws administered by the FDA.

   The use of circuitGuard while choosing to reuse
    anesthesia breathing circuits is not considered
    reprocessing.


                                                        63
   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.




                                                     64
65

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Cost-Effective Filtration and Humidification Solutions for Ventilator and Surgery Patients

  • 1. 1
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 8. 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. 8
  • 9. 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. 9
  • 10. 10
  • 11. There is a potential risk of bacterial and viral infection being transmitted through anaesthesia circuits.  Several studies have shown contamination of parts of anaesthetic equipment with bacteria that colonize the mouth and upper airway.  Among the recommendations for preventing transmission of infection through anaesthetic circuits are using a bacterial/viral filter for every patient or using disposable circuits.  Assoc Physicians India (2001) 49: 454-8. 11
  • 12. Study Objective:  Although there is no clinical evidence for using one alternative anesthetic device over another, we have introduced the systematic use of filters with patients undergoing general anesthesia.  We describe the features of filters available on the market and our protocol for their use. 12
  • 13. Conclusion:  The ideal filter is hydrophobic and does not increase circuit resistance over the amount specified with the following four principles: 1.The filter forms a part of the patient, not the apparatus. 2.Proper placement of the filter is between the patient and 13
  • 14. Conclusion: 3. The main purpose of the filter is to prevent contamination of the apparatus. 4. If a hydrophobic filter is used with each patient, the use of a disposable respiratory circuit is not called for.  Rev Esp Anestesiol Reanim 1994 Nov-Dec; 41 (6): 322-7 14
  • 15. It would appear that the ISO standard only applies to dry heat and moisture exchange filters.  Anaesthesia, July 2010 Volume 65 670-673 15
  • 16. STUDY OBJECTIVE:  To investigate bacterial contamination of anaesthetic breathing circuits and means of prevention.  CONCLUSION:  The presence of a HMEF provides protection of the anaesthetic circuit as well as other patients, healthcare workers and the environment.  J Hosp Infect 1992 May; 21 (1): 51-60 16
  • 17. 17
  • 18. Particulate inclusions, drawn to scale, that may be found in a carrier gas. ©2001 by American College of Chest Physicians; Demers R Chest 2001;120:1377-1389
  • 19. 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. 19
  • 20. More loading surface  Highest charge/density available  Lifetime charge in fiber  Each fiber has both positive and negative charge -- bipolar charges 20
  • 21. The most basic form of filtration, the particle is larger than the space between two fibers, and so, cannot follow the airstream through and is captured. 21
  • 22. Diffusion occurs specifically with very small particles which follow irregular patterns, in a manner similar to gases, and not necessarily following the airstream. This irregular pattern is known as Brownian motion and increases the particles chance of capture through contact with the fibers. 22
  • 23. The mechanism by which large, high density particles are captured is called impingement. As the particulate laden air passes through the filter media, the air tends to pass around the fibers. Inertia of the particulate causes it to separate from the airstream to collide with the fibers to which they become attached. 23
  • 24. Interception occurs when a particle follows the airstream but still attaches itself to the fiber as it passes around it. This is due to the electrostatic force attracting the particle towards the fiber where it is retained. 24
  • 25. 25
  • 26. 26
  • 27. 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. 27
  • 28. We have an exclusive advantage in our manufacturing process. This process is designed so that the top and bottom halves of the device will not fit together unless the filter is properly seated, thus providing 100% inspection for seal and blow by.  Other manufactures depend on glue or ultrasonic welding to seal their halves together.  circuitGuard ™ is built without fail points -- meaning no glue or ultrasonic welding is used, only a compression fit. 28
  • 29. 29
  • 30. “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. 30
  • 31. 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. 31
  • 32. Many choose to reuse their anesthesia circuits 32
  • 33. ARC Medical Inc 33 Member
  • 34. 34
  • 35. 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".  35
  • 36.  “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.” 36
  • 37. “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 37
  • 38. “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 38
  • 39. circuitGuardTM Sales 2009 - 2012 39
  • 40. 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 40
  • 41. “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 41
  • 42. “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 42
  • 43. 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. 43
  • 44. 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. 44
  • 45. There are no reported touch contamination incidents between the anesthesia provider and any equipment (knobs, flat and horizontal surfaces, CO2 lines, etc.). 45
  • 46. The circuitGuardTM System Patient Elbow HCH Media ETCO2 Port Ridge & Lip Construction Circuit Connection 46
  • 47. 47
  • 48. 48
  • 49. Our independent cross-contamination study shows 100% efficiency against cross contamination. circuitGuard ™ with HME combo circuitGuard ™ filter only combo 49
  • 50. 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). 50
  • 51. Fewer products used 51
  • 52. 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 52
  • 53. 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. 53
  • 54. Reduces environmental stress: An estimated 12 million circuits are disposed of each year. 54
  • 55. Or white bag their circuits which means the circuits are considered not contaminated. 55
  • 56. Reduces inventory and storage costs 56
  • 57. circuitGuard ™ with HME combo circuitGuard ™ filter only combo 57
  • 58. 58
  • 60. Yes, we have FDA labeling approval.  “Indications: Protection of patients from excessive heat and moisture loss. Protection of patients and equipment from contamination.   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. 60
  • 61. circuitGuard™ is a hydrophobic, 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. 61
  • 62. 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. 62
  • 63. It is not unlawful to reuse single use devices (SUDs); however, hospitals and third parties that reprocess single use devices must comply with the reprocessing laws administered by the FDA.  The use of circuitGuard while choosing to reuse anesthesia breathing circuits is not considered reprocessing. 63
  • 64. 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. 64
  • 65. 65