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

Duty cycle / frequency

• maximum: 30/sec
• minimum:

Weird ISO requirements

• Temperature stability:

• Shock and vibration (201.15.3.5.101.1): Amazing to have; would allow official use during transport

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

• Must have: Battery-powered
• Must have: Ability to connect to continuous power
• Nice to have: Multiple abilities in one device

Compliance

• UL, CE

Buttons

• Nice to have: Button silences alarm x 5 minutes
• Remove reset button
• Add power switch

Failure conditions

• Must have: Cut display if voltage makes readings unreliable
• Nice to have: Warning if voltage will soon become too low

Self-test

Self-test mode

• Allow test mode that tests each LED
• Can be activated by holding button for 20 seconds

During operation

• Report technical fault if 100% signal or 0% signal

Alarms

See 201.13 (Hazardous situations and fault conditions)

Visual

Dashes or blinks to report technical fault (no finger; no reading; self-test failure)

Auditory

Version 1.0: No alarms Version 2.0: SpO2 alarm (to be determined) Version 3.0: SPO2 alarm, CO alarm

Conversion values

R value will be taken and calculated (See FF.1)

Calculation:

See page 62 of ISO (Addendum FF.1)