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©2021-2023 Belun Technology

Belun® Ring

BLR - 100X

Belun® Ring is for medical professionals that need high quality patients’ data meeting medical-standard and with 510(k) clearance from the US Food and Drug Administration (FDA).

Belun provides FDA-510(k) Class II cleared hardware & software for sleep apnea diagnosis & monitors sleep health through clinically validated AI algorithms.

Unlike other competitors in the market, Belun® Ring is easy to use, affordable with medical accuracy.

The Belun® Ring measures

  • Oxygen Saturation (SpO2)
  • Pulse Rate (PR)
  • Apnea Hypopnea Index (bAHI)
  • Sleep Stages : Awake, REM, NREM
  • Autonomic Nervous System (ANS) Response
  • Actigraphy
Belun® Ring 100X

Introducing Belun® Ring

FDA_510k_cleared_word

World 1st FDA 510(k) cleared wearable ring using

Artificial Intelligence

for Obstructive Sleep Apnea Diagnosis with sleep stages

ISO13485_cert_no

ISO 13485 medical devices quality management system

TFDA_class_II

Taiwan FDA Class II  medical-grade wearable

FDA_Thailand

FDA Thailand Class III medical-grade wearable

over 20 Patents worldwide

Easy to use

Minimal disruptions to daily sleep routines

Clinical validation

10,000+ sleep reports worldwide from diverse ethnic backgrounds

Quick Diagnosis

3-nights sleep reports ready within 10 minutes

Thinking to include Home-Sleep-Apnea Testing (HSAT) service from your clinic?

We provide a one-stop solution with an HSAT report to your inbox to walk through with your patient. Reach out for details.

How to use?

Put the ring on before sleep. A sleep report will be generated automatically in the morning, revealing your sleep apnea risk, sleep efficiency, and stress level.

The Belun® Ring helps you discover the quality of your sleep — at home, comfortably, by simply putting on your ring before bedtime.

You will uncover the mysteries of:

  • Risk of sleep apnea
  • Sleep quality

The Belun® Ring equips its users with information that empowers them to change their daily habits — such as activities, exercise, alcohol intake, and medication — to improve their sleep health.

The Belun® Ring’s report also enables professionals to evaluate how users’ daytime activities affect sleep quality and to review sleep health holistically and scientifically in an unprecedented way in the marketplace.

All physiological data, analysis, and sleep reports can be viewed and downloaded by people from clinics, health-check centers, respiratory machine vendors, and elderly centers, which provides additional insights to physicians.

Technical Specifications

Using the spectrophotometric methodology, the Belun® Ring measures blood oxygen saturation by illuminating the skin and measuring changes in light absorption of oxygenated (oxyhemoglobin) and deoxygenated (reduced hemoglobin) blood using two light wavelengths: red and infrared. The ratio of absorbance at these wavelengths is calculated and calibrated against direct measurements of arterial oxygen saturation (SaO2) to establish the pulse oximeter’s measurement of functional oxygen saturation of arterial hemoglobin (SpO2).

  1. The sensor should be placed on the palmar side of the proximal phalanx of the index finger and along the radial artery. The accuracy of the device will be minimally affected by the skin color.
  2. Worn at the proximal phalanx of the index finger & minimises sensor motion artifact
  3. Small, lightweight (14 gram) and cableless design
  4. Non-intrusive measurement at night
  5. Multiple-night home sleep test

International standards

The Belun® Ring complies with the following international standards:

  • IEC 60601-1:2005+AMD1:2012 CSV
  • IEC 60601-1-2:2014
  • IEC 60601-1-6:2013
  • IEC 60601-1-11:2015
  • ISO 62366-1:2015
  • IEC 62133:2012
  • IEC 62304:2015
  • ISO 10993-1:2018
  • ISO 10993-5:2009
  • ISO 10993-10:2010
  • ISO 80601-2-61:2017

SpO2 Parameter

  • Range: 0% – 100%
  • Accuracy: 70%-100%: ±2.7%, below 70%: unspecified
  • Average: 8 seconds
  • Data Update Period: 8 seconds

Pulse Rate Parameter

  • Range: 30bpm – 250bpm
  • Resolution: 1bpm
  • Accuracy: ±2.5bpm or ±2% whichever is larger
  • Average: Average over 8 beats

Power Source

  • Internal Battery: 3.7V rechargeable lithium battery
  • Charging Input: DC 5V, 700mA

Recording Time

Battery Time

  • Ring can record up to 10 hours with a single charge
  • Cradle can charge the Ring for ~7 nights of recording (~10 hours each)

Data Memory

  • Ring can store up to 10 hours of data
  • Cradle can store up to 120 hours of data

Dimension

  • Ring: 44 x 60 x 18mm
  • Cradle: 32 x 100 x 59mm

Weight

  • Ring: ~14g
  • Cradle ~97g