Frequently Asked Questions
All
How can I purchase a BLUEWAVE device?
Patients must access BLUEWAVE treatment through their clinic or healthcare provider. To find out the nearest clinic with a BLUEWAVE or wish to request your local clinic purchase a BLUEWAVE,
Click Here.
If you are a clinician or a healthcare provider looking to buy a BLUEWAVE device
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?
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.
To Learn More Click Here. The BLUEWAVE device 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 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 in lab tests.
Does the BLUEWAVE device kill the COVID-19 virus (SARS-CoV-2)?
The BLUEWAVE device 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 the BLUEWAVE unit is effective at killing methicillin-resistant Staphylococcus aureus (MRSA, a vegetative Gram-positive bacterium) and MS2 bacteriophage (a non-enveloped virus).** Both MRSA and MS2 are expected to be more resistant to disinfection than SARS-CoV-2.*
* Efficacy of the BLUEWAVE device against the SARS-CoV-2 virus is expected in accordance with FDA’s Guidance Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency dated March, 2020. Per this guidance, enveloped viruses such as SARS-CoV-2 are typically considered less resistant to germicides than both vegetative bacteria and non-enveloped viruses.
** When used in accordance with instructions for use, the BLUEWAVE device achieved a > 6-log10 reduction versus 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 these same surfaces.
What is the lifetime of the BLUEWAVE device?
The BLUEWAVE device can last approximately 6,000 regular cycles before servicing is needed. At 8 cycles per day, 5 days per week, this comes out to approximately 3 years until the device needs servicing.
This estimated time frame will be shortened by increased usage intervals, usage of the Super Cycle, and treatment of larger items. We do offer extended warranty packages that will enable your clinic to have lower downtime, in the event a unit was to need servicing. Please contact us about our Pro Service Plans.
Does the BLUEWAVE use harmful chemicals?
The BLUEWAVE device uses no added chemicals to function. The device generates its active ingredient (ozone) on demand within the device. The BLUEWAVE’s 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.
COVID-19 virus/Cleaning Effectiveness
Does the BLUEWAVE device kill the COVID-19 virus (SARS-CoV-2)?
The BLUEWAVE device 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 the BLUEWAVE unit is effective at killing methicillin-resistant Staphylococcus aureus (MRSA, a vegetative Gram-positive bacterium) and MS2 bacteriophage (a non-enveloped virus).** Both MRSA and MS2 are expected to be more resistant to disinfection than SARS-CoV-2.*
* Efficacy of the BLUEWAVE device against the SARS-CoV-2 virus is expected in accordance with FDA’s Guidance Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency dated March, 2020. Per this guidance, enveloped viruses such as SARS-CoV-2 are typically considered less resistant to germicides than both vegetative bacteria and non-enveloped viruses.
** When used in accordance with instructions for use, the BLUEWAVE device achieved a > 6-log10 reduction versus 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 these same surfaces.
What does the BLUEWAVE device kill?
The BLUEWAVE device can kill the COVID-19 virus (SARS-CoV-2) and has also been proven to kill 99.99% of MRSA on hard surface carriers and 2-ply polyester in lab tests.
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.
*Data from independent pilot study.
Purchases And Pricing
How can I purchase a BLUEWAVE device?
Currently, the BLUEWAVE device 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 using OrtoPed as our Canadian distributor, so please contact them for availability and pricing Click Here.
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. Purchase a BLUEWAVE To Qualify For The Pilot Program Today!
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.
*Data from independent pilot study.
How much does a BLUEWAVE cost?
Currently, the BLUEWAVE device is only avalible for purchase by clinicians and healthcare providers. Paitents must access BLUEWAVE Treatment through their clinic or provider. To find the nearest clinic with a BLUEWAVE or wish to request your local clinic purchase a BLUEWAVE Click Here.
If you are a clinician, you can Sign Up to become a BLUEWAVE member. This will give you exclusive access to the BLUEWAVE device and accessories. Click Here to become a BLUEWAVE member today!
What is the lifetime of the BLUEWAVE device?
The BLUEWAVE device can last approximately 6,000 regular cycles before servicing is needed. At 8 cycles per day, 5 days per week, this comes out to approximately 3 years until the device needs servicing.
This estimated time frame will be shortened by increased usage intervals, usage of the Super Cycle, and treatment of larger items. We do offer extended warranty packages that will enable your clinic to have lower downtime, in the event a unit was to need servicing. Please contact us about our Pro Service Plans.
Is BLUEWAVE Safe?
Does the BLUEWAVE use harmful chemicals?
The BLUEWAVE device uses no added chemicals to function. The device generates its active ingredient (ozone) on demand within the device. The BLUEWAVE’s 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?
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 .To learn more Click Here. The BLUEWAVE device 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 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 in lab tests.
Legal
Product Terms & Conditions
BLUEWAVE Technologies, Inc. Product Terms and Conditions
THESE PRODUCT TERMS AND CONDITIONS (the “Agreement”) ARE ENTERED INTO BETWEEN BLUEWAVE TECHNOLOGIES, INC. (“BLUEWAVE”) AND THE LEGAL ENTITY THAT PURCHASED A BLUEWAVE PRODUCT (DEFINED BELOW) (SUCH ENTITY, “CUSTOMER”) ON WHOSE BEHALF THE ULTIMATE END-USER WILL USE THE BLUEWAVE PRODUCT(S). THIS AGREEMENT IS A LEGALLY BINDING CONTRACT BETWEEN BLUEWAVE AND CUSTOMER.
BY PLACING AN ORDER FOR, ACCESSING OR USING THE BLUEWAVE PRODUCT(S), CUSTOMER AGREES THAT CUSTOMER HAS READ AND UNDERSTOOD, AND, AS A CONDITION TO CUSTOMER’S USE OF THE DEVICE, CUSTOMER AGREES TO BE BOUND BY, THIS AGREEMENT. IF CUSTOMER DOES NOT AGREE TO THIS AGREEMENT, THEN CUSTOMER DOES NOT HAVE PERMISSION TO USE THE BLUEWAVE PRODUCT(S).
The BLUEWAVE Device (“Device”) is and ozone vacuum-infusion device 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 on the Super Cycle setting. 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.**
The Device 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).
Consumable components that work in conjunction with the Device include: a Filter Cartridge to remove excess ozone after treatment, optional Scent Cartridges to infuse items with aromatics, an Extension Port Adapter, and treatment bags with appropriate diffuser attachments (collectively “Consumables”). The Device and Consumables are collectively and severally referred to in this Agreement as BLUEWAVE Product(s).
* 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. 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.
INITIAL TRAINING REQUIREMENT
Customer will participate in an initial training session in one of the following formats: in-person, by video call, or by logging in and viewing the training videos on BLUEWAVE’s website. The format will be determined at BLUEWAVE’s sole discretion after consultation with Customer.
USE OF DEVICE AND CONSUMABLES
Customer will only use the Device and Consumables as described in the Terms of Use (Appendix A). Customer will only use Consumables that are manufactured by BLUEWAVE, and will never attempt to use or create Consumables that are not BLUEWAVE Products for use with the BLUEWAVE Device.
NOTIFICATION BY CUSTOMER OF DEVICE MALFUNCTION
If the Device stops working properly, for example Customer smells ozone during a treatment cycle, Customer will unplug the Device immediately, and notify BLUEWAVE of the malfunction via phone (352-474-5489) or email support.mybluewave.com as soon as is reasonably possible.
WARRANTY ON PARTS AND LABOR
BLUEWAVE warrants to Customer that the BLUEWAVE Products will be free from material defects in materials and workmanship under normal authorized use consistent with the Initial Training and the Terms of Use (Appendix A) (collectively “Instructions for Use”) for a period of twelve (12) months from the date of shipment from BLUEWAVE (the
“BLUEWAVE Warranty Period”). If the BLUEWAVE Products proves defective under the foregoing warranty during the BLUEWAVE Warranty Period, Customer must notify BLUEWAVE in writing within 30 days of when Customer becomes aware or reasonably should have become aware of the defect. BLUEWAVE, at its option, will either (i) repair the defective BLUEWAVE Product(s) without charge for parts and labor or (ii) provide a replacement in exchange for the defective Device. The BLUEWAVE Products, replacement parts and components may include materials that are reconditioned. During the warranty period, BLUEWAVE’s liability and Customer’s exclusive remedy is limited, at BLUEWAVE’s option, to replacing, repairing, correcting, or issuing credit for any BLUEWAVE Product subject to the warranty, which upon inspection BLUEWAVE determines is non-conforming. This Warranty does not apply to (a) BLUEWAVE Products purchased from unauthorized resellers; (b) where a BLUEWAVE Product is used contrary to Instructions for Use; or (c) where a BLUEWAVE Product is damaged as a result of abuse, accident, unauthorized modification or other causes beyond BLUEWAVE’s reasonable control.
Complete instructions for safe and proper use may be accessed by registering and logging in to the member portal at mybluewave.com.
After the BLUEWAVE Warranty Period expires, BLUEWAVE may, at its discretion, repair or replace the BLUEWAVE Products at Customer's expense for parts, labor, processing and shipping. Additional protection may be obtained by purchasing a Pro Service Plan (ask distributor or go to mybluewave.com and login for details). TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, AND EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH ABOVE IN THIS SECTION 4, NEITHER PARTY MAKES ANY WARRANTIES WHATSOEVER IN CONNECTION WITH THIS AGREEMENT AND HEREBY DISCLAIMS ALL OTHER WARRANTIES, INCLUDING ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON- INFRINGEMENT.
PROHIBITION OF DISASSEMBLY AND REVERSE ENGINEERING
Customer will not disassemble or reverse engineer any parts of the BLUEWAVE device or accessories, or facilitate or permit third parties to do so.
PROHIBITION OF TRANSFER TO THIRD PARTIES
Customer will not sell or transfer the Device in any way to any third party without the written consent of BLUEWAVE.
INDEMNIFICATION AND RELEASE OF CLAIMS
Customer is solely liable and responsible for harm that arises out of use of the Device that does not comply with the Initial Training or the Terms of Use (Appendix A). Customer will indemnify, defend, and hold harmless BLUEWAVE against any and all losses, damages, and reasonable costs and expenses incurred in connection with any third party claim, demand, action, proceeding, investigation, or hearing resulting from Customer’s (i) negligence, gross negligence or intentional misconduct; or (ii) failure of Customer to adhere to the Terms of Use. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW: IN NO EVENT SHALL BLUEWAVE’S AND ITS AFFILIATES’ AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, STRICT LIABILITY, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EXCEED THE TOTAL THE AMOUNT PAID BY CUSTOMER FOR THE BLUEWAVE PRODUCTS INVOLVED IN THE DISPUTE; AND, IN NO EVENT SHALL BLUEWAVE OR ANY OF ITS AFFILIATES BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF, OR RELATING TO, OR IN CONNECTION WITH THIS AGREEMENT, REGARDLESS OF (a) WHETHER SUCH DAMAGES WERE FORESEEABLE, (b) WHETHER OR NOT BLUEWAVE WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, (c) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND (d) THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
CONFIDENTIALITY
Customer will treat communications regarding the Device development and BLUEWAVE’s business development as confidential unless otherwise notified by BLUEWAVE. Customer will use the same efforts to protect BLUEWAVE’s confidential information from loss or alteration, and unauthorized access, use or disclosure, that it uses to protect its own confidential information of similar sensitivity, but in no event will such efforts be less than reasonable efforts.
OWNERSHIP OF INTELLECTUAL PROPERTY
Customer acknowledges and agrees that: (a) as between the Parties, Bluewave solely owns all intellectual property rights in and to the Products; (b) Customer will not acquire any ownership interest in any such intellectual rights under this Agreement; (c) if Customer acquires any intellectual property rights in or to any Products (including any rights in any patent improvements relating thereto) by operation of law or otherwise such rights are hereby irrevocably assigned to Bluewave without any further consideration due to Bluewave; and (d) except for Customer’s right to use the BLUEWAVE Products in accordance with this Agreement, and certain limited licenses granted, in writing, by
BLUEWAVE to Customer to use BLUEWAVE’s trademarked or copyrighted material in connection with promotional materials advertising Customer’s use of BLUEWAVE Products, the sale of BLUEWAVE Products does not grant to, convey or confer upon Customer or any Third Party any rights or licenses, whether express or implied, under any patent right, copyright or other intellectual property right of Bluewave. Customer will not take any action that reasonably could be expected to challenge, undermine or otherwise interfere with any of Bluewave’s intellectual property rights in or to the Products.
SEVERABILITY
If any term or provision of this Agreement is deemed unenforceable by a court of competent jurisdiction, such unenforceability will not affect any other term or provision of this Agreement. Upon a determination that any term or provision is unenforceable by any court of competent jurisdiction, the court may modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
NO CONSTRUCTION AGAINST DRAFTER
Because this Agreement is intended to provide a simplified description of the duties of both parties, the provisions of this agreement shall be construed in accordance with the fair meaning of the language used and shall not be strictly construed against either party.
GOVERNING LAW
This Agreement will be governed in all respects by the laws of the State of Delaware, United States of America without regard to its conflict of laws principles.
COMPLETE AGREEMENT
This Agreement, including all exhibits attached hereto, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, regarding such subject matter. If there is any conflict or inconsistency between this Agreement and any exhibit attached hereto, the Agreement will control to the extent of the conflict or inconsistency.
APPENDIX A: TERMS OF USE
FOR THESE TERMS OF USE, “CUSTOMER” INCLUDES BOTH CUSTOMER AND CUSTOMER’S EMPLOYEES AND AGENTS. THESE TERMS OF USE MAY BE UPDATED BY BLUEWAVE AT ITS SOLE DISCRETION TO IMPROVE SAFETY AND EFFICACY.
Customer will follow all directions in the Initial Setup Guide and User Manual provided with this device.
Customer will ensure that only Customer and employees or agents of Customer will use the Device. Customer will ensure that anyone who uses the device has participated in a training session with BLUEWAVE.
Customer will only use the Device according to these Terms of Use, the Initial Training, Instructions for Use, and video tutorials. Detailed Instructions for Use and video tutorials may be found by logging in to the customer portal at www.mybluewave.com.
Although the treatment bags may be used up to 50 times for the same patient’s device(s), Customer will not use the same bag for multiple patients’ devices.
Customer will never attempt to dismantle, take apart, repair, or otherwise manipulate the affixed components of the Device other than to replace the filter cartridges, scent cartridges or treatment bags in accordance with the training session conducted by BLUEWAVE.
Customer will never put flammable material or vapors (e.g., rubbing alcohol, solvents) into the BLUEWAVE or run the BLUEWAVE within six feet such materials or vapors.
Customer will not put any wet or damp items in the Device.
The Device is heavy and has some components that may break or malfunction if mishandled. Customer will exercise all reasonable care when handling, using or transporting the Device, and will hold BLUEWAVE harmless and indemnify BLUEWAVE from any claims arising out of handling, using, lifting or carrying the BLUEWAVE.
Customer will only use treatment bags, filters, and scent cartridges supplied by BLUEWAVE and, unless otherwise agreed in writing, Customer will not use the same bag to treat items belonging to different patients.
Prior to treatment, be sure to remove any debris and gross particulate matter including sweat, blood, dirt, skin buildup, and the like. Damp items should be dried prior to treatment. Wet materials cannot be treated because the vacuum pressure will suck moisture into the machine and damage it.
Customer will only use the BLUEWAVE on the following items*:
Cranial Helmets, AFOs, Small Braces, Walking Boots, Shoe Inserts, Prosthetic Liners, BK/Pediatric Sockets
*Additional items may be added by mutual agreement of the parties.
Because the items treated are comprised of so many materials and components and BLUEWAVE cannot reasonably examine each prior to treatment, to the fullest extent permitted by applicable law, Customer will indemnify and hold BLUEWAVE harmless for damage to items treated in the Device.
IMPORTANT NOTE: For rigid items that form a hollow cavity, slack in the treatment bag must be pushed into the cavity before starting treatment. DO NOT USE ON ITEMS WITH ELECTRICAL COMPONENTS OR CIRCUITRY, OR ON ITEMS THAT USE PNEUMATICS
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