Fingertip Pulse Oximeter

Shuunnya Care

Fingertip Pulse Oximeter

Plus or minus 2 percent is a root mean square figure, not a bound. About a third of readings sit further out.

₹1,490

₹1,850

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Pack size: 1 oximeter

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₹1,490

1 oximeter

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The Shuunnya promise

An accuracy figure explained rather than quoted, a measured skin pigmentation bias published by group, and a plain statement of what this instrument is not.

  • Plus or minus 2 percent Arms from 70 to 100 percent, with Arms explained
  • Skin pigmentation bias measured by group and published, not claimed away
  • Below 70 percent saturation the accuracy is unspecified and we say so
  • Not a diagnostic instrument. Cold hands, polish and mehndi defeat it

Details

A fingertip oximeter that estimates blood oxygen saturation and pulse rate, with the things that make it wrong printed on the same page as the things that make it right. Every oximeter on the shelf says plus or minus 2 percent. Almost none say what that number is. It is Arms, a root mean square error measured against arterial blood samples across a controlled desaturation study. It is a statistic, not a limit. If a device is 2 percent Arms then roughly a third of its readings are more than 2 percent from the truth and about one in twenty is more than 4 percent out. A reading of 94 on a good oximeter is compatible with a true value of 90 to 98. The second thing is skin. Pulse oximeters read light through tissue and melanin absorbs light, so they tend to overestimate saturation on darker skin, most at low saturations, which is exactly where an error costs the most. This is documented and it is almost never printed. Our validation panel was recruited across a measured range of skin pigmentation and the bias by group is in the report: on the most pigmented group the device read on average 1.4 percent high at true saturations between 70 and 80 percent, against 0.4 percent on the least pigmented. That gap does not disappear because a pack does not mention it. And cold hands, nail polish and mehndi all defeat it, which in India is worth saying out loud.

  • SpO2 accuracy plus or minus 2 percent Arms from 70 to 100 percent. Below 70 percent the accuracy is not specified, by anyone, and the number should not be relied on
  • Pulse rate 30 to 250 beats per minute, plus or minus 2 beats or 2 percent, whichever is larger. Resolution 1 percent and 1 beat
  • Reading settles in about 8 seconds, with a perfusion index shown so you can see whether the signal was worth trusting
  • Skin pigmentation bias measured and published by group, not asserted as tested on all skin tones
  • Four-way rotating OLED with a plethysmograph waveform. The waveform is not decoration: a ragged trace means the number under it is unreliable
  • Two AAA cells, user replaceable, about 30 hours. Fits fingers 8 to 25 mm, so it suits children above about four
  • It measures. It is not a diagnostic instrument, it is not a screening test, and it cannot tell you why a number is what it is
  • Cold fingers, nail polish, gel nails, mehndi, shivering, movement and bright overhead light all degrade it. Warm the hand, use a bare finger, sit still, and shade the sensor

Product information

Accuracy, and what the accuracy figure actually is
SpO2 accuracy
Plus or minus 2 percent Arms from 70 to 100 percent saturation
What Arms means
Root mean square error against arterial co-oximetry across a controlled desaturation study. It is a statistic, not a maximum. At 2 percent Arms roughly a third of readings are further than 2 percent from the truth and about one in twenty is further than 4
Below 70 percent
Not specified. No fingertip oximeter is validated below 70 percent because the desaturation study does not go there. Treat a reading below 70 as an alarm to act on, not as a measurement
SpO2 range and resolution
70 to 100 percent displayed, resolution 1 percent
Pulse rate
30 to 250 beats per minute, plus or minus 2 beats or 2 percent whichever is larger, resolution 1 beat
Perfusion index
0.2 to 20 percent, displayed. Below about 0.4 the signal is too weak to trust and the unit says so
Time to reading
About 8 seconds after a steady trace appears
Standard
Tested to ISO 80601-2-61, the particular standard for pulse oximeter equipment
Wavelengths
Red at 660 nm and infrared at 905 nm, both under 15 mW
Skin tone, and the other things that make it read wrong
Why skin matters
The device reads light through tissue and melanin absorbs light. Oximeters tend to overestimate saturation on darker skin, and the effect is largest at low saturations, which is where an error costs most
Panel
Validation subjects recruited across a measured range of skin pigmentation by individual typology angle, rather than a convenience panel
Measured bias, most pigmented group
Reads on average 1.4 percent high at true saturations of 70 to 80 percent, and 0.6 percent high from 90 to 100
Measured bias, least pigmented group
Reads on average 0.4 percent high at true saturations of 70 to 80 percent
What that means for you
On darker skin a low reading is more likely to understate how low the real value is. It does not make the device useless, and it does mean a borderline number deserves a phone call rather than a repeat test
Nail polish and gel
Both block the light path. Dark colours are worst. Use a bare finger
Mehndi
Fresh mehndi on a fingertip will affect the reading in the same way as dark polish. Use another finger
Cold hands
The commonest cause of a low or unstable reading at home. Warm the hand for a few minutes first and watch the perfusion index come up
Movement and light
Shivering, tremor and a bright overhead light all corrupt the trace. Sit still and shade the sensor
Also affected by
Carbon monoxide exposure, some dyes used in imaging, and very low blood pressure. None of these are visible in the number
Build, power, regulatory and the limits
Display
OLED, four-way rotating, showing saturation, pulse, perfusion index and a plethysmograph waveform. A ragged waveform means the number above it is unreliable
Finger size
8 to 25 mm, which suits children above about four. Below that the finger is too small to seat and the reading is not dependable
Power
Two AAA cells, user replaceable. About 30 hours of use. Nothing is sealed in
Auto off
8 seconds after the finger is removed
Weight
50 g with cells
Regulatory
A notified medical device under the Medical Devices Rules 2017, manufactured under a CDSCO licence. Class B
What this is not
It is not a diagnostic instrument and it is not a screening test. It cannot tell you why a number is what it is, and it cannot rule anything in or out
If a reading worries you
Call a doctor. Do not repeat the test until it gives a number you prefer, which is the single commonest misuse of this device
Warranty
Two years on the unit. Cells are consumables and are not covered
In the box
Oximeter, two AAA cells, lanyard, cloth pouch, instruction card in English and Hindi

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