What is your set temperature? At what temperature your alarm is set @?

Thanks

Our set temp is 35.5 and alarm temp is 36.5.

Ours is set at 36.5 and it goes off at 37.3 or 37.4 C.

Ours is set at 36.5 and it goes off at 37.3 or 37.4 C.

Same here

You might want to adjust the temp to 37.0 (for shutoff). Anything over 37.0 is out of compliance for FFP. See Technical Manual 15th edition page 191, 16th edition page 292. I know of someone who was sited for having alarm set over 37.0.

Our set temperature is 36. Our alarm temperature is 37. We were cited for having our alarm temperature at 37.5 (the factory preset). We didn't even think about that because we had never owned a waterbath with an alarm. Silly us, to think that the manufacturer might put their preset to fit the regulation!

Ours is set at 35.5 and alarms at 36.5. If the alarm is set to go off at 37, there is no opportunity to intervene and take corrective action on the setting. 35.5 works well and it does not delay preparation of plasma products. We are a large, trauma center and this works well for us. Our thaw time is set for 18 minutes with a full thawer.

You might want to adjust the temp to 37.0 (for shutoff). Anything over 37.0 is out of compliance for FFP. See Technical Manual 15th edition page 191, 16th edition page 292. I know of someone who was sited for having alarm set over 37.0.

This is a gray area...Tech Manual...FFP may be thawed at temperature of 30 to 37 C or in FDA-approved device.

Standard 5.18A Thaw at 30-37C or using an FDA cleared device. But for Cryo it says thaw at 30-37C.

Because of wording FDA cleared device I thought we can keep factory setting???

I think the "FDA cleared device" refers to Microwaves not thawbaths.

Set: 36.5

Alarm: 37.3

Logic:

Why 36.5?

To be as warm as possible, but far away enough from the alarm set point so that it is not alarming all the time.

Why 37.3?

All regs previously mentioned give only two significant digits (37, not 37.0). The temperature controller display on the Helmer DH4 and DH8 gives an additional digit (37.n), but you can only be held to the number of sig digits in the regs. To compare your set point to the reg, you must round your set point to the nearest two digit number. Therefore, rounding 37.3 to 2 digits = 37 and you're good.

To JLF:

The thing in AABB about setting alarms to go off before the temp range is exceeded is specific to STORAGE devices, and a thawer is not a storage device.

Edited May 6, 200916 yr by webersl
added JLF reference

I think the "FDA cleared device" refers to Microwaves not thawbaths.

I agree with clmergen on this

Our set point on temp is36.2 and the alarm is set for 37.1

I agree with clmergen on this

You are correct. I checked with someone at AABB and FDA cleared device is for Microwave. It's only indicated under plasma not under cryoprecipitate so that make sense that, that part of reg. is for microwave.

See all of us can interpret standard differently. Anyway I was told that if temp goes above 37 during thawing we will not be in compliance. In other words my alram should be set at 37.

Thank you all for your help.

I tried to set mine for 37.1 when we received the citation, but AABB accreditation refused to accept that, interpreting it as out of range. I agree with Webersl that the idea of setting it before it goes out of temperature to allow intervention applies to storage devices. and not thawers. For one thing, who is going to set a thawer working and not come back for 4 hours? :-)

Set temp is 36.5 and alarm temp is set to 36.9

Set temp is 36.5 and alarm temp is set to 36.9

Do you get lots of alarms as your hi set point is too close to set temp.??

My alarm setting is not based upon a rule for storage devices, it is set on worst case scenario. I want my staff to have the ability to respond to the alarm in time to save product should the waterbath temp continue to rise. There is no right or wrong answer here as long as we comply with Standards.

Trust me- if you set the alarm for 37.3 and the set temp is 36.5, the product will not be in the water for long if your Helmer is working properly. It will lift the product out promptly. The biggest problem is getting the Helmer to stop alarming after you test it.

Trust me- if you set the alarm for 37.3 and the set temp is 36.5, the product will not be in the water for long if your Helmer is working properly. It will lift the product out promptly. The biggest problem is getting the Helmer to stop alarming after you test it.

Yes you are right...you need to wait until temp. goes back to normal...do you let your tech. turn off watebath to remove alarm??

The worst case scenario would also have the basket lift not function.

Do you get lots of alarms as your hi set point is too close to set temp.??

No Aakupaku,

We do not see many alarms with these settings.

So, how does one stop the alarm sounding?

What is the low set at?

To stop the alarm, hit the "mute" button.

We do not set a low alarm.

Our temp is set at 36.0, alarm is set at 37.1. When the alarm goes off, the baskets lift the plasma out of the water. We do turn the unit off to lower the temp faster. We have had rare occassions when the basket lift malfunctions at the end of the cycle, but has not happened yet with a high alarm.

Barbara

As I noted earlier, setting the alarm at 37.1 was not acceptable to AABB. I don't know how they would feel about not having a low alarm, since there is a low end to the recommended temperature range. We have both a low and high alarm. (30 and 37)

No Aakupaku,

We do not see many alarms with these settings.

That is interesting. After reading these posts I decided that I would change my high alarm setting from 37.1 to 36.9. Our set temp was 36.5. We immediately saw that there would be a problem with this when everytime we thawed a unit the alarm went off and the baskets came out. I changed the set point to 36.0 and since then we have had no problems.