Re: FDA Approval
I can¡¯t send you the stuff that is privy to the FDA. It dawns on me I have my own document that I did on this and I can send you that. Everywhere that I say ¡°I haven¡¯t reviewed this¡± is fair
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Gordon Gibby KX4Z
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#1840
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Re: FDA Approval
Hey, I will see if I¡¯m allowed to send that to you, and I can point some of the ones out if you wish.
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Gordon Gibby KX4Z
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#1839
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Re: FDA Approval
Thanks, I'm reviewing the FDA doc and pulling the indicated ISO specs. When you said there were 34 questions, do you have an actual list of questions, or were you referring to the requirements listed
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Steve S
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#1838
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Re: FDA Approval
Here is the FDA document
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Gordon Gibby KX4Z
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#1837
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Re: FDA Approval
Could you post or provide the FDA documents. I THINK I have a pretty good understanding of the vent and could try to address some of the questions. Without knowing the questions, I can't guarantee
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Steve S
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#1836
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Re: Where to find plans for physical assembly
Awesome, thanks for providing this. I really like the idea of gluing the the template into the cover. I have two thoughts for your consideration that might make the box easier to clean. First is the
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Steve S
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#1835
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Re: FDA Approval
(RE: PVC). It isn't an optimal answer, but it is the only one we have. You either want an emergency ventilator....or you don't. This is the best our group can do given the timeline. Cheers, Gordon
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Gordon Gibby KX4Z
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#1834
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Re: FDA Approval
Everythng Im working on now is to get us through the FDA. 1.? We had a defined number of failures on our tests by both software sets; a small team of us have been working on the SIMPLE CODE and
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Gordon Gibby KX4Z
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#1833
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Re: FDA Approval
That helps more than you know! Thank you!
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William.ogilvie1@...
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#1832
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Re: FDA Approval
Thanks again for the update!
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Kris Galante
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#1831
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Re: FDA Approval
Will, the answer is as follows: 1)? everyone in the world is exposed to PVC.? ?it is NOT a respiratory sensitizer (e.g., Latex *is*) 2)? We measured the VOC? (volatile organic degassing) and it
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Gordon Gibby KX4Z
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#1830
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Re: FDA Approval
Hi, I am new to this forum and am with a team here in Oklahoma creating an EUV. I am sure you all have solved this issue previously but I'm struggling to find a set answer in the previous discussions.
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William.ogilvie1@...
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#1829
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Re: Where to find plans for physical assembly
Attached is the Draft Version 1.1 of the physical assembly document, hot off the press....and undoubtedly it isn't perfect. Enjoy!!
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Gordon Gibby KX4Z
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#1828
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Re: FDA Approval
JUst as soon as we qualify the 16x2 code with my objective tests....we freeze that design and move forward!!! Gordon
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Gordon Gibby KX4Z
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#1827
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Re: FDA Approval
I hope we can move to standardize to a 20x4 display too
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Ashhar Farhan
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#1826
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Re: FDA Approval
Things are moving faster and faster.? ?The mechanical engineers are just about done with their flow sensor project.? ?We had a glitch with one of the pressure transducer chips -- those things DO
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Gordon Gibby KX4Z
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#1825
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Re: Active PEEP
A note:? ?Dave Lizdas informed me that he has seen? some fluctuations in the airway pressure when the expiratory valves of commercial ventilators open/close to work their way to that desired PEEP
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Gordon Gibby KX4Z
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#1824
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Re: Active PEEP
I don't think it will make much difference. There is probably a slight difference in the peak pressure if you measure further down the inspiratory limb since the tubing is slightly flexible and will
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Steve S
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#1823
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Re: FDA Approval
Thanks for remembering me Gordon. ?I am not ignoring you or your team. ?You have plenty of cooks in the kitchen at the moment. ?I am following what is going on and will intervene when I have
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MA
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#1822
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Re: Active PEEP
Well, I¡¯m not sure about that at all because there¡¯s nothing really active going on during inspiratory pause, but it (moving the pressure measurement all the way over to the patient )
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Gordon Gibby KX4Z
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#1821
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