|
|
Post by joey on May 13, 2024 15:53:39 GMT
Just curious how everyone changes the Diacap?
Who does it?
Do they pull the machine to do it?
I know you have to disinfect afterwards.
Does everyone know the updated instructions in the box says the machine has to be turned off to change it?
Thanks
|
|
|
|
Post by joey on May 14, 2024 11:26:14 GMT
bump
|
|
|
|
Post by SrCusEngr on May 14, 2024 15:39:07 GMT
<joey> This is from a 2009 version of the Diacap IFU.
Attachments:
|
|
|
|
Post by joey on May 14, 2024 15:47:44 GMT
Yeah, that updated ifu is in the box now, but I was more talking about how each unit handles it.
I'm asking because I was told we should pull the machines to change the filter which I do not agree with and with only 4 spares they are setting themselves up to not have enough machines if you get a few breakdowns and they pulled 3 machines the night before because of filters.
Also who does it in these units.
|
|
|
|
Post by Admin on May 14, 2024 18:30:30 GMT
Hi Joey,
For my point of view - the DF Filter Exchange is documented in the IFU - which is the operators manual that is given to the staff. The Service Manual being for trained techs only. It describes how to exchange it and mentions nothing about the machine being pulled - although you should do a disinfect after. I would say since it is readily available in the IFU that the staff has access to, the staff should be able to do this.
|
|
|
|
Post by joey on May 14, 2024 19:02:38 GMT
<joey> This is from a 2009 version of the Diacap IFU.
I am curious why they want you to turn the machine off. It seems to work fine draining it then using old dialyzer caps to keep it from spilling then just replace it. Wipe it down and disinfect it. Maybe just to prevent fluid leakage? |
|
|
|
Post by Chuck Weddle on May 14, 2024 19:52:50 GMT
Joey,
What SrCusEngr posted is at least 15 years old so, I wouldn't call that "updated".
It sounds like you're dealing with a facility policy, not what Braun says?
We don't use the filters so my details may not be 100%. I believe the message starts coming up X number of treatments before the filter should be changed. Logic would be to change it after its last treatment before it's daily disinfection. I don't know if it's really necessary to turn the machine off or not but, is it really that big of a deal?
I agree with Admin that it should be done by the clinical staff, at the end of the day prior to disinfection.
|
|
|
|
Post by joey on May 14, 2024 21:23:45 GMT
Thanks Chuck I actually found a different version on Bbraun somewhere when I first looked last year. It didn't have you turn off the machine and the ifu in the box now is a revision dated 2022. Thats why I assumed it was a newer update.
I honestly don't care about turning it off or not I was just curious as to the logic. Even if things do not affect me, I still like to learn. I do them all now and the decision makes no sense, so I just wanted some input.
It expires after 900 hours or 150 treatments, whichever you hit first. I am still trying to get them to look at the wrench screen regularly just to identify ones that are coming close.
It's also not a policy yet I have to write the policy but I'm talking to my medical director about it Thursday.
|
|
|
|
Post by SrCusEngr on May 14, 2024 23:46:51 GMT
Joey, What SrCusEngr posted is at least 15 years old so, I wouldn't call that "updated". It sounds like you're dealing with a facility policy, not what Braun says? We don't use the filters so my details may not be 100%. I believe the message starts coming up X number of treatments before the filter should be changed. Logic would be to change it after its last treatment before it's daily disinfection. I don't know if it's really necessary to turn the machine off or not but, is it really that big of a deal? I agree with Admin that it should be done by the clinical staff, at the end of the day prior to disinfection. Chuck, the clip that I posted from 2009 was to show that the wording has not changed (Removal of the DUDFF) till present.
Now I have a paradox for you, joey and Admin, since you all contributed:
I said the wording of the 2009 Diacap IFU was the same as the present (02/2022) Diacap IFU (see my attachment previous) and it says to turn off the machine. NOTE: This is an IFU - what you MUST do.
Now go to the Dialog IFU (May 2003; Rev 2.18.02), chapter 10, para 10.5.2 and note that it states that the filter is replaced with "the hemodialysis machine turned on."
Also the Diacap IFU never mentions to reset the machine data after replacement while the Dialog IFU does.
So the paradox is: Which IFU (lawful operation) would you comply with?  |
|
|
|
Post by SrCusEngr on May 14, 2024 23:54:31 GMT
<joey> For machines with 9.1E software, the warning message (you are within 10 treatments or 40 hours) only appears AFTER the first treatment of the daySo even with 3 treatments a day, you still have two days worth remaining. It is an advisory to be prepared. Don't force them to look. They will get the notice. (.1B and earlier gave the warning at turn-on/prep and that caused machines to be pulled even before a patient went on, causing delays and wracked nerves to get a new machine out there. The message is not an immediate change out command.
|
|
|
|
Post by Chuck Weddle on May 15, 2024 8:33:04 GMT
So the paradox is: Which IFU (lawful operation) would you comply with? Maybe "someone" <hint> should put a bug in Braun's ear to fix this discrepency. Since everything has to come from Germany and get held up in legal.....It might get fixed in 8-9 years!  |
|
btech
Junior Member
Posts: 55
|
Post by btech on May 15, 2024 12:29:12 GMT
I dont know were you found that the machine should off during the filter change. in my version of the diacap ultra IFU there is nothing written like that Attachments:
|
|
|
|
Post by joey on May 15, 2024 16:51:44 GMT
I dont know were you found that the machine should off during the filter change. in my version of the diacap ultra IFU there is nothing written like that  evision dated 5/22 |
|
|
|
Post by Chuck Weddle on May 15, 2024 17:14:59 GMT
Looks like there is a difference between the Europeon IFU and the one for the US.
|
|
|
|
Post by SrCusEngr on May 15, 2024 20:07:27 GMT
<btech> That is NOT the one we receive in our Diacap filter boxes. At least your version says to follow the machine instructions. Even pre-2009 versions for the US stated to turn off the machine. (Just looked back in my archive files). Our IFU is 8 pages with the page 1/2 showing EN-US inside a circle in the upper right of page 1 and EN-CA inside a circle in the upper right of page 3.
<Chuck et. al.> A SIM has been submitted (kinda like a PIR).
|
|
