Specification

Reference is ISO 80601-2-61

Accuracy

• Covered in section 201.12 of ISO 80601-2-61
• How many beats before display
• 2-4 beats (current market: 10-20s)
• % accuracy:
  • 3% for SpO2 within 70-100%
  • 0.2% for Carboxy hemoglobin
  • Heart rate: 10 bpm

Display

• Non-normalized waveform will indicate signal quality (201.12.4.102, see NOTE)
• Waveform should run ~90% of the length of the display with ~25% of the height
• Waveform should run 5 seconds of data (subject to change. May be 10 seconds)
• Sample display: http://www.qmuniforms.com/photos/styles/DD006_1500_1.jpg

Physical

• Dimensions of finger clip
• Length of wire - 1-3 m
• Dimensions of device - unconstrained
• Weight - unconstrained

Electrical

Requirements

Compliance

Alarms