Extensive Software / Hardware Valuation Testing
The Phlebotest™ is subjected to rigorous validation testing to ensure the software program always communicates appropriately with mechanical movements of the chair.
Comprehensive Hazard (Risk) Analysis
A comprehensive risk analysis was conducted to ensure that each potential risk to both patient and technician is addressed.
System Space Requirements
68x78x60 inches in the home position and 40x84x60 inches in the supine position.
Environmental Condition Requirements
Minimum 10 C / 50 F working condition temperature.
Maximum 35 C / 95 F working condition temperature.
Maximum 90% RH working condition humidity (non condensing)
Minimum -20 C / -4 F storage and shipping temperature
Maximum 50 C / 122 F storage and shipping temperature
Max 95% RH storage and shipping humidity (non condensing)
Electromechanical Interference
The Phlebotest™ has been tested and found to comply with the limits for medical devices to IEC 601-1-2; edition 1 (or EN 60601-1-2; edition 1 and EN60601-1, plus amendments 1, 2,11,12, and 13). This testing shows the device provides reasonable protection against harmful interference in a typical medical installation.*
Computer/Printer Requirement (minimum)
A laptop or desktop computer (not provided) and external printer (provided) will be necessary to run the provided Phlebotest™ software. Minimum system requirements are:
• Meets IEC 60950 or equivalent
• Pentium III Processor (800 MHZ or higher) or Equivalent AMD Processer
• 64 MB RAM or higher
• 12” monitor screen (Resolution set to 800 * 600)
• CD-Rom drive
• Windows 98, ME, 2000; XP or later versions
• 40 MB available on hard drive
• Color printer (inkjet or laser)