Development of a continual in-line blood analysis monitor for the monitoring of vital blood parameters during extracorporeal circulation in heart surgery.

Herausforderungen in der Entwicklung
  • Development from scratch (not a follow-up product)
  • Project start including feasibility study
    Compilation of the initial product requirements and evaluation of the concepts in workshops with the customer
  • Early assembly of a function model (also for usability engineering)
    Integration project
  • Cooperation and coordination of both sensor development partners
  • Test units for production
  • Duration of project to delivery of the first series device (manufactured at Mechatronic): 24 months
  • Disciplines
    – Mechanics: thermoformed plastic case, metal chassis (table and mast-mount)
    – Electronic engineering: micro controller and embedded PC
    – Software: C++ and Windows XP (GUI) (Interfaces: USB / USB Host / 2 x RS232)
  • Size of team: Nine developers on average, in project peak times fifteen developers
  • Life Cycle Management (LCM)
    – Change Management
    – Obsolescence Component Management
    – Second Level Service
    – Re-design (3rd edition, 4th edition, additional parameters)
  • Measures on display
    – Arterial partial oxygen pressure (pO2)
    – Arterial temperature
    – Venous oxygen saturation (O2Sat)
    – Venous hematocrit (Hct)
    – Venous hemoglobin (Hb)
    – Venous temperature
  • Site of operation
    – Patient near-field
    – OP
  • Interfaces (among others)
    – Printer
    – USB-Stick