Operating Manual
SAFE HANDLING
Software-Version 2.6
B|BRAUN
Chapter 1
Page 5 of 10
SHARING EXPERTISE
2.6_CA-EN_03
1.2 INTENDED USE AND INDICATIONS
The H.E.L.P. Plasmat® Futura machine can be used for
implementing and monitoring extracorporeal
treatments of plasma. The system can be used for
patient treatment in a hospital and health center
when prescribed by a physician.
H.E.L.P. Plasmat® Futura machine may only be used
in combination with the H.E.L.P. apheresis
treatment system from B. Braun Avitum AG.
The H.E.L.P. Futura apheresis system is indicated for
use in performing low density lipoprotein cholesterol
(LDL-C) apheresis to acutely remove LDL-C from the
plasma of the following high risk patient populations
for whom diet has been ineffective and maximum
drug therapy has either been ineffective or not
tolerated:
Group A:
Functional Hypercholesterolemic Homozygotes with
LDL-C > 500 mg/dl;
Group B:
Functional Hypercholesterolemic Heterozygotes with
LDL-C
300 mg/dl; and
Group C:
Functional Hypercholesterolemic Heterozygotes with
LDL-C
200 mg/dl and document coronary heart
disease (CHD).
Documented CHD is defined as having one or more of
the following:
• a prior documented myocardial infarction (MI);
• a prior coronary artery bypass graft surgery (CABG);
• a prior percutaneous transluminal coronary
angioplasty (PTCA) with or without atherectomy or
coronary artery stent placement; or
• significant angina pectoris with a positive thallium
or other heart scanning stress test.
