Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.

Inclusion Criteria:

• Ability to provide written informed consent
• Ability and willingness to comply with the study procedures and duration requirements
• 18 years of age or older
• Consented to undergo an apheresis procedure with an automated blood component device

Exclusion Criteria:

• Females who are pregnant or breastfeeding
• Undergone an amputation of the left upper extremity
• Diagnosed with dextrocardia
• Subjects who have a pacemaker