Medtronic Affinity CP BBAP40 Gebrauchsanweisung Seite 15

■
blood loss
■
blood toxicity
■
death
■
embolus
■ excessive blood component activation
■ exsanguination
■
fever
■
hemolysis
■
hypercarbia and acidosis
■
hypotension
■
hypovolemia
■
hypoxia
■ impaired patient temperature management
■ infection
■
neurological dysfunction and stroke
■
organ dysfunction
■
renal failure
■
reproductive harm in male neonatal and pediatric patients
■
respiratory and pulmonary issues
■
sepsis
■
sterilization
■ thrombus
■
toxemia, carcinogenicity, mutagenicity, sensitization, cytotoxicity
■
vasculature damage
7. Instructions for Products with Balance™ Biosurface
The blood-contacting surfaces of the device are coated with Balance Biosurface to reduce platelet activation and adhesion and
preserve platelet function.
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0
Warning: A product coated with Balance Biosurface is intended for single use only.
2 Comparison between Balance Biosurface coated and uncoated in vitro bench test circuits through percentage of platelets that
are activated with adenosine diphosphate (ADP @ 20 µM) in circulating heparinized human blood over time. Error bars represent
standard deviation. (* indicates p<0.05)
*
*
*
10 30 60
1
Figure 2. Functional platelets over time (in vitro testing)
1. Time (min)
3
2. Functional Platelets (%)
4
3. Uncoated (control)
*
4. Balance-coated
120
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Instructions for Use English 13