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
₹2,790
Standard cuff, 22 to 32 cm
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
Quality & reports
Shuunnya VerifiedIndependent quality and lab reports for this product — download to verify.
- Clinical Validation to ISO 81060-2:2018, 85 Subjects and 255 Paired Readings Lab report · NABL-accredited Medical Device Testing Laboratory, Bengaluru · 2026-05 Download
- Electrical Safety and EMC to IEC 60601-1 and IEC 60601-1-2, with IEC 80601-2-30 Lab report · NABL-accredited Electrical Safety Laboratory, Bengaluru · 2026-05 Download
- Manufacturing Licence for a Notified Medical Device, Medical Devices Rules 2017 Certificate · Central Drugs Standard Control Organisation · 2026-05 Download
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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