Upper Arm Blood Pressure Monitor

Shuunnya Care

Upper Arm Blood Pressure Monitor

Validated to ISO 81060-2 with the figures printed. An unvalidated oscillometric monitor is a number generator.

₹2,790

₹3,400

-18%

Inclusive of all taxes

Cuff size: Standard cuff, 22 to 32 cm

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₹2,790

Standard cuff, 22 to 32 cm

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The Shuunnya promise

A published clinical validation with its actual numbers, and a cuff size chosen from a measured arm rather than assumed.

  • Validated to ISO 81060-2:2018 on 85 subjects and 255 paired readings
  • Systolic 1.8 plus or minus 5.4 mmHg, diastolic 1.2 plus or minus 4.9 mmHg
  • Two cuffs with arm circumference and bladder size both printed
  • Three readings averaged automatically, with a loose-cuff flag

Details

An upper arm monitor with a published clinical validation and two cuff sizes, because those are the two things that decide whether a home reading is worth anything. An oscillometric monitor does not measure blood pressure. It inflates a cuff, records the pressure oscillations as it deflates, and runs a proprietary algorithm over the amplitude curve to estimate systolic and diastolic. The estimate is an educated guess about numbers it never directly observed. What turns that guess into a measurement is a clinical validation: the device tested against trained observers with a mercury or equivalent reference on a recruited subject panel, to a published protocol, with the mean difference and standard deviation reported. Most home monitors sold in India have never been through one, and a manufacturer is free to sell an unvalidated algorithm. There is nothing on the box to tell you. So the validation and its numbers are here.

  • Validated to ISO 81060-2:2018, the AAMI, ESH and ISO universal standard, on 85 subjects and 255 paired readings
  • Systolic mean difference 1.8 mmHg with a standard deviation of 5.4. Diastolic 1.2 mmHg with 4.9. Criterion 1 allows a mean of 5 with a standard deviation of 8, so both pass with room
  • Static pressure accuracy plus or minus 3 mmHg. That is the pressure sensor, and it is not the same thing as the reading being right. A sensor can be perfectly accurate about cuff pressure while the algorithm turns it into the wrong blood pressure, which is the whole reason validation exists
  • Cuff size is the commonest cause of a wrong home reading. A cuff too small over-reads, sometimes by 10 to 30 mmHg. Too large under-reads. So two sizes, with the arm circumference and the bladder dimensions both printed
  • Standard cuff 22 to 32 cm with a 13 by 24 cm bladder. Large cuff 32 to 42 cm with a 16 by 32 cm bladder. Measure your upper arm once with a tape before ordering
  • Three readings taken 30 seconds apart and averaged automatically, which is what a clinic does and what a single reading cannot be
  • Irregular heartbeat indicator and a loose-cuff flag, so a bad fit is caught rather than averaged in
  • 120 readings for each of two users with date and time. Four AA cells or the mains adaptor included, and the cuff is a replaceable part
  • It measures. It does not diagnose, it does not grade hypertension, and it is not a substitute for a clinic reading. Take readings at the same time each day, sit still for five minutes first, and take the log to your doctor

Product information

Validation, and why it is the whole product
Protocol
ISO 81060-2:2018, the AAMI, ESH and ISO universal standard for non-invasive sphygmomanometer clinical investigation
Panel
85 subjects, 255 paired readings, arm circumferences spread across both cuff ranges, against two trained observers with a reference sphygmomanometer
Systolic result
Mean difference 1.8 mmHg, standard deviation 5.4. Criterion 1 allows a mean of 5 with a standard deviation of 8
Diastolic result
Mean difference 1.2 mmHg, standard deviation 4.9
Criterion 2
Passed. The per-subject mean differences hold within the standard deviation the protocol permits for the observed mean
What an oscillometric monitor does
It records cuff pressure oscillations during deflation and runs an algorithm over the amplitude curve to estimate systolic and diastolic. It never directly observes either number
Why that needs validating
The algorithm is a manufacturer's own. Without a validation against trained observers there is no evidence the estimate corresponds to anything, and nothing on a box distinguishes a validated algorithm from an unvalidated one
Static pressure accuracy
Plus or minus 3 mmHg. This is the pressure transducer, per IEC 80601-2-30, and it is a different claim: a sensor can be exactly right about cuff pressure and still produce a wrong blood pressure
Pulse accuracy
Plus or minus 5 percent of reading
Measuring range
0 to 299 mmHg cuff pressure, pulse 40 to 180 per minute
Cuff, fit, and the commonest reason a home reading is wrong
Standard cuff
22 to 32 cm upper arm circumference. Bladder 13 by 24 cm
Large cuff
32 to 42 cm upper arm circumference. Bladder 16 by 32 cm
Why size decides the reading
A bladder too short for the arm needs more pressure to occlude the artery, so the monitor over-reads, sometimes by 10 to 30 mmHg. Too long and it under-reads. This is a larger error than the instrument's own
How to choose
Put a tape around the bare upper arm midway between shoulder and elbow, arm relaxed at your side. Read the centimetres and pick from the two ranges above. Do it once
If you are between sizes
At exactly 32 cm either cuff will fit. Take the large one, because a bladder slightly long is the smaller error of the two
Cuff type
Wide-range soft cuff, one-handed fitting, with an index line and range marking printed inside so a wrong fit is visible before you press start
Loose-cuff flag
The unit detects an under-tightened cuff and refuses the reading rather than averaging it in
Replacement
The cuff is a separate part and wears out before the unit does. Sold separately, so the monitor outlives it
Averaging
Three readings 30 seconds apart, averaged. A single reading is a snapshot of a number that moves minute to minute
Power, memory, regulatory and the limits
Memory
120 readings for each of two users, with date and time, and a separate morning and evening average
Power
Four AA cells or the mains adaptor included. About 300 readings on a set of cells
Display
Backlit LCD with large digits, an irregular heartbeat indicator and a cuff-fit indicator
Regulatory
A notified medical device under the Medical Devices Rules 2017, manufactured under a CDSCO licence. Class B
Electrical safety
Tested to IEC 60601-1 for medical electrical equipment and IEC 60601-1-2 for electromagnetic compatibility, with the adaptor in circuit, at a NABL-accredited laboratory
Particular standard
IEC 80601-2-30, the particular standard for automated non-invasive sphygmomanometers
What it does not do
It does not diagnose, it does not grade hypertension, and it does not replace a clinic reading. It gives you a log a doctor can use
Reading well
Same time each day, sitting, back supported, feet flat, arm at heart height, five minutes still beforehand, no tea, coffee or tobacco for thirty minutes, and do not talk during the measurement
Warranty
Three years on the unit, one year on the cuff, which is a wear part
In the box
Monitor, chosen cuff, mains adaptor, four AA cells, storage case, log book, validation summary, instruction card in English and Hindi

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