Frequently Asked Questions
How does the Goldilocks Valves system work?
Can the Refill Regulating Valve be adjusted during use?
Can the Refill Regulating Valve be shut off?
Do I still have to verify with chest rise?
Does the Goldilocks Valves system negatively affect the function of other existing valves on the BVM?
Can the Goldilocks Valves system be purchased and attached to any existing manual resuscitator?
Can the same bag be used for pediatric and adult patients?
Has the Goldilocks Valves achieved FDA clearance?
- Check out a detailed explanation and video on our About page.
Can the Refill Regulating Valve be adjusted during use?
- Yes. Adjustments can be made to the valve setting by simply clicking the toggle to the desired setting.
Can the Refill Regulating Valve be shut off?
- Yes. The "Open" setting on the valves serve as an off function. On this setting, the manual resuscitator functions at baseline without interference from the valve. This is the default setting. Use and activation of the valve is user determined.
Do I still have to verify with chest rise?
- Yes. Chest rise remains a gold standard indicator for appropriate tidal volume during manual resuscitation. This indicator will help ensure the appropriate use and application of the Goldilocks Valves.
Does the Goldilocks Valves system negatively affect the function of other existing valves on the BVM?
- No. In fact, in some cases, the Goldilocks Valves may even enhance the benefits of other valves. For example, impedance threshold devices (ITD) do not function optimally in the presence of excessive respiratory rates. Because the Goldilocks Valves system aids in the regulation of appropriate respiratory rate, ITD performance serves to benefit.
Can the Goldilocks Valves system be purchased and attached to any existing manual resuscitator?
- We are still seeking a licensing partner for the Goldilocks Valves. In concept, the Refill Regulating Valve and Grip Chart will be manufactured into the manual resuscitator directly. However, it is could be possible in some embodiments that the system can be applied post manufacturing.
Can the same bag be used for pediatric and adult patients?
- In theory, that is a possibility that could be explored with future licensing partners. However, current BVM have adult and pediatric sizes with corresponding masks that are not universal. This is a challenge that would have to be addressed before a universal bag incorporating the Goldilocks Valves could reach the market.
Has the Goldilocks Valves achieved FDA clearance?
- Not yet. We are are in the research and development process. A research regulatory report has been completed by a regulatory specialist regarding the recommended FDA pathway for the Goldilocks Valves. The report determined that the Goldilocks Valves can achieve FDA clearance via the 510k pathway.
