Autonomous Blood Drawing Optimization and Performance Testing

Inclusion Criteria:

• Age ≥16 years.

Exclusion Criteria:

• Unable to follow instructions, due to mental disability and/or incapacity

• Unable to use device correctly due to physical impairment or disability (for examplea patient with severe contractures or deformities)

• No venipuncture possible in cubital fossa of both arms (for example: afteramputation of both arms)

• No venipuncture possible in cubital fossa due to contra-indications in both arms (for example: tattoos in both arms)

• Incapacitated persons

• Pregnant or breast-feeding

The following contra-indications / exclusion criteria are respected per arm:

• Arteriovenous fistula or vascular graft

• Paretic or paralyzed arm (e.g. after stroke or trauma)

• Infected skin in cubital fossa (for example: erysipelas or cellulitis)

• Mastectomy side, axillary lymph node excised

• Healed skin burns in cubital fossa

• Edema in cubital fossa

• Extensive scarring in cubital fossa

• Hematoma in cubital fossa

• Tattoos in cubital fossa

In case the test subject has a suitable contralateral arm, the subject can be included in this study. In Study Phase B2, a manual venipuncture and automated venipuncture are performed in both arms. Patients who have a contra-indication in one arm are excluded from the Phase B2 study.