Frequently Asked Questions
General
Can I buy a BLUEWAVE?
Yes, if you are purchasing for a clinic or healthcare provider. To purchase,
click here.
Currently, BlueWave is only available for purchase by clinics or healthcare providers.
Patients can receive a BlueWave treatment through their clinic or provider.
To find the nearest clinic near you with a BlueWave Device,
click here.
If you wish us to contact your clinic to suggest they purchase a BlueWave,
click here
.
Will the ozone from the BLUEWAVE irritate my skin?
We have never heard of patients experiencing any adverse effects from devices that have been treated with ozone. In fact, we have received reports from clinicians saying that certain skin problems on babies’ heads seem to have cleared up after using the BLUEWAVE to treat their cranial helmets. Because the BLUEWAVE automatically filters out excess ozone ozone, and infuses fresh air multiple times at the end of the treatment cycle, there is very little residual ozone left and a patient can put his or her device back on immediately.
How much does a BLUEWAVE treatment cost?
While BlueWave works with clinics to set up Service Plans with patients, we are currently allowing the clinics to set the price of the plans. Please contact your local clinic for details.
To learn more
Click Here.
What is ozone? Is ozone dangerous?
Ozone (O3) is a naturally occurring gas that quickly reacts with things it comes into contact with (e.g., bacterial cell walls, odor molecules, etc.). When it reacts, it loses an oxygen atom and reverts back to O2. The EPA sets maximum safe ozone exposure levels to .070 ppm for 8 hours exposure. The BLUEWAVE is a closed loop system that converts excess ozone back to Oxygen. We have tested the output at the filter and in the treatment bag after treatment and we are well below the EPA and OSHA limits.
Here is a link to our study. Click Here
Does BLUEWAVE Kill CoVid-19/Corona virus?
BLUEWAVE is intended to be effective at killing SARS-CoV-2 (the virus that causes COVID-19) when used in accordance with its labeled instructions for use. It is indicated for use on non-critical instruments and surfaces that only contact intact human skin such as prostheses and orthoses, as well as blood pressure cuffs, stethoscopes, and patient clothing.* Anticipated efficacy against SARS-CoV-2 is supported by test results demonstrating that BLUEWAVE is effective at killing methicillin-resistant Staphylococcus aureus and MS2 bacteriophage.** BLUEWAVE is available for the intended use stated above per FDA’s Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency dated March, 2020. This device has not been formally cleared for this indication under a 510(k) notification (21 CFR 807). * Low level disinfection of the SARS-CoV-2 virus is expected when used in accordance with instructions for use. ** In laboratory testing, BLUEWAVE achieved a > 6-log10 reduction versus methicillin-resistant Staphylococcus aureus ATCC 33591 (MRSA) on hard, non-porous stainless steel carriers and soft, porous polyester fabric. A > 3-log10 reduction was observed versus MS2 bacteriophage on hard, non-porous stainless steel carriers and soft, porous polyester fabric (on Super Cycle Setting ~25 minutes). Both MRSA and MS2 are expected to be more resistant to germicides than the SARS-CoV-2 virus per guidance provided in FDA’s Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency dated March, 2020. \cteriophage on these same surfaces.
Covid-19/Killing Germs
Can we use BLUEWAVE on Masks/PPE?
We are currently testing BLUEWAVE's ability to treat masks, but testing facilities are experiencing high volumes of testing requests, and we appreciate your patience while we're moving through the process. Please sign up to become a BLUEWAVE member and we update you on our progress.
Does BLUEWAVE Kill CoVid-19/Corona virus?
BLUEWAVE is intended to be effective at killing SARS-CoV-2 (the virus that causes COVID-19) when used in accordance with its labeled instructions for use. It is indicated for use on non-critical instruments and surfaces that only contact intact human skin such as prostheses and orthoses, as well as blood pressure cuffs, stethoscopes, and patient clothing.*
Anticipated efficacy against SARS-CoV-2 is supported by test results demonstrating that BLUEWAVE is effective at killing methicillin-resistant Staphylococcus aureus and MS2 bacteriophage.**
BLUEWAVE is available for the intended use stated above per FDA’s Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency dated March, 2020. This device has not been formally cleared for this indication under a 510(k) notification (21 CFR 807).
* Low level disinfection of the SARS-CoV-2 virus is expected when used in accordance with instructions for use.
** In laboratory testing, BLUEWAVE achieved a > 6-log10 reduction versus methicillin-resistant Staphylococcus aureus ATCC 33591 (MRSA) on hard, non-porous stainless steel carriers and soft, porous polyester fabric. A > 3-log10 reduction was observed versus MS2 bacteriophage on hard, non-porous stainless steel carriers and soft, porous polyester fabric (on Super Cycle Setting ~25 minutes). Both MRSA and MS2 are expected to be more resistant to germicides than the SARS-CoV-2 virus per guidance provided in FDA’s Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency dated March, 2020. \
Cleaning Effectiveness
Does BLUEWAVE Kill CoVid-19/Corona virus?
BLUEWAVE is intended to be effective at killing SARS-CoV-2 (the virus that causes COVID-19) when used in accordance with its labeled instructions for use. It is indicated for use on non-critical instruments and surfaces that only contact intact human skin such as prostheses and orthoses, as well as blood pressure cuffs, stethoscopes, and patient clothing.*
Anticipated efficacy against SARS-CoV-2 is supported by test results demonstrating that BLUEWAVE is effective at killing methicillin-resistant Staphylococcus aureus and MS2 bacteriophage.**
BLUEWAVE is available for the intended use stated above per FDA’s Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency dated March, 2020. This device has not been formally cleared for this indication under a 510(k) notification (21 CFR 807).
* Low level disinfection of the SARS-CoV-2 virus is expected when used in accordance with instructions for use.
** In laboratory testing, BLUEWAVE achieved a > 6-log10 reduction versus methicillin-resistant Staphylococcus aureus ATCC 33591 (MRSA) on hard, non-porous stainless steel carriers and soft, porous polyester fabric. A > 3-log10 reduction was observed versus MS2 bacteriophage on hard, non-porous stainless steel carriers and soft, porous polyester fabric (on Super Cycle Setting ~25 minutes). Both MRSA and MS2 are expected to be more resistant to germicides than the SARS-CoV-2 virus per guidance provided in FDA’s Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency dated March, 2020. \
Can we use BLUEWAVE on Masks/PPE?
We are currently testing BLUEWAVE's ability to treat masks, but testing facilities are experiencing high volumes of testing requests, and we appreciate your patience while we're moving through the process. Please sign up to become a BLUEWAVE member and we update you on our progress.
Does this Rapid Deodorization Device disinfect and kill germs?
Yes! Ozone is a molecule comprised of three oxygen atoms. Ozone attacks the cell walls of bacteria* and is intended to
kill SARS-CoV-2 . Ozone leaves no residue behind on items being treated.
How effective is it at reducing odor?
There is a greater than 95% reduction in odor after one treatment in the BlueWave device. The Bluewave device destroys the odor molecules AND the source of the odor.
Purchases And Pricing
Can I Purchase A BLUEWAVE?
Currently, BlueWave is only available for purchase by clinics or healthcare providers.
If you are a Clinician or HealthCare Provider looking to buy a BlueWave Device Click Here.
Patients must access BLUEWAVE treatment through their clinic or provider. To find out the nearest clinic with a BLUEWAVE or wish to request your local clinic purchase a BLUEWAVE, click here.
I'm from Canada, when and where can I buy a BLUEWAVE?
Thank you so much for your interest. We've gotten a lot of requests from Canada, and we are currently working through the regulatory process to sell there. We are going to use Ortoped as our Canadian distributor, so please contact them for availability and pricing.
What is the Pilot Program?
If you join our Pilot Program, you will receive a discount in exchange for sharing information regarding patient feedback and usage of the bluewave device within your clinic.
This Includes Recording The Following:
1. Take notes of odor level assesment before and after treatment (from both patient and clinician)
2. Ask patients how long the deodorization effect lasted or when did the odor return to the level prior to treatment.
3. Track the number of users and what items are being treated during the pilot study.
What happens after the Pilot Program?
We will offer a discount for the new model when it’s available. You get to keep the unit you have.
How do I keep my patients from abusing the BLUEWAVE Service Plan?
We recommend that you limit cleanings to once per week.
We recommend that you provide the service during paitents scheduled appointments.
Does the BLUEWAVE use harmful chemicals?
The Bluewave Device uses no added chemicals to function. The device generates its active ingredient on demand within the device. The BlueWave closed loop system increases the efficiency of the treatment gas, enhancing the speed of the cycle. The only active ingredient is ozone. Once the cycle is completed, the remaining ozone is filtered out via the filter cartridge.
How effective is it at reducing odor?
There is a greater than 95% reduction in odor after one treatment in the BlueWave device. The Bluewave device destroys the odor molecules AND the source of the odor.
Is BLUEWAVE Safe?
Does the BLUEWAVE use harmful chemicals?
The Bluewave Device uses no added chemicals to function. The device generates its active ingredient on demand within the device. The BlueWave closed loop system increases the efficiency of the treatment gas, enhancing the speed of the cycle. The only active ingredient is ozone. Once the cycle is completed, the remaining ozone is filtered out via the filter cartridge.
What is Ozone? Is Ozone Dangerous?
Ozone is a molecule comprised of three oxygen atoms (O3). Ozone attacks odor molecules and bacteria* cell walls through oxidation. Unlike many chemical disinfectants, Ozone doesn’t leave a chemical residue behind. When Ozone reacts, it loses an oxygen atom and reverts back to the Oxygen that is found in air (O2). The EPA sets maximum safe ozone exposure levels to .070 ppm for 8 hours exposure (http://www.gpo.gov/fdsys/pkg/FR-2015-10-26/pdf/2015-26594.pdf). The BLUEWAVE is a closed loop system that uses our filter to convert excess ozone back to Oxygen at the end of the treatment cycle. We have tested the output at the filter and in the treatment bag after treatment and we are well below the EPA and OSHA limits. Here is a link to our study. Click Here.
*kills 99.9% of MRSA on hard surface carriers and 2-ply polyester.
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