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HEMATRAX PRINTER VALIDATION


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Our tried and true Hematrax printer has finally just about bit the dirt and will need to be replaced. We will probably go with the updated Hematrax printer as a replacement. My question is: Once the printer is installed, what validation processes do we need to complete prior to being put into use? The labels should not change, so what is required?

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We had a site that needed to do this and they wrote a simple validation plan and worked with the local site support team on the install.  Once it was delivered the local site support person worked with the vendor, there was some software that needed to be loaded from Hematrax (not sure what that was).  He was also responsible for all the network connections and anything hardware related.  

He then did a factory "calibration" to make sure the printer actually printed something.  I think the printer may have spit out some labels, I supported remotely so I wasn't onsite when the desktop guy did that part.

The Blood Bank manager then did some thawing and splitting "for real" as this was set up on a production server.  It was a high volume place so none of the products would have gone to waste.

The manager did what she felt was applicable to the site, she printed duplicate labels on the products so there was documentation that the labels printed correctly.  They also captured screen shots from the BB system to provide documentation that nothing was affected with the actual application.

Maybe someone closer to the front lines has done something similar but our site had no problems with the validation plan and documentation when all of the acronym accreditation agencies showed up on her door step.

 

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Hello: Make sure you replace your current HemaTrax printer with the same 300 dpi print resolution and it's
loaded with the Digi-Trax proprietary Blood Bank ABO-Rh firmware. Once the right replacement printer is in 
place and properly loaded with ISBT128 labels/ribbon (only if labels are thermal transfer), there is really 
no validation requirements to complete prior to its use. HemaTrax end users usually don't validate the 
printer, but do validate the HemaTrax software. So, as long as the printer is configured correctly (Network 
and in HemaTrax), then it's ready to put into use. Thanks,

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