Biosensor BX100 Wearable biosensor

Biosensor BX100

Wearable biosensor

989803203011

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A medical-grade, wireless device that adheres discreetly to the chest, the Philips Biosensor BX100 measures vital signs, posture and activity while allowing patient mobility. It is designed to work with IntelliVue GuardianSoftware to aid early identification of patient deterioration, driving early intervention.

Specifications

Physical specifications
Physical specifications
Size
  • 96 mm x 61 mm x 7.1 mm (3.78 in x 2.40 in x 0.28 in) without release liners
Weight
  • 10 g (0.35 oz)
Battery
  • CR2032, 3V primary cell
Memory
  • 1 MB, non-volatile flash
Durability
  • Survives shock & vibration per IEC60721-4.7; Class7M2; survives free fall (1 m drop) per IEC 60601-1
Water ingress protection
  • IP27 (IEC 60529:2013)
Latex
  • Not manufactured with natural rubber latex
Usage specifications
Usage specifications
MRI safe
  • No
Single use
  • Yes, single use only
Operational life
  • Biosensor can be chest-worn up to 120 hours (5 days)**
Disosable
  • Yes
Serviceable
  • No
Performance
Performance
Respiration rate measurement
  • 3-40 respirations per minute (rpm)
Respiration rate accuracy
  • ±3 rpm (excluding periods of undefined respiration rate due to patient talking, eating or coughing)
Respiration rate resolution
  • 1 rpm
Heart rate measurement
  • 30 - 220 beats per minute (bpm)
Heart rate accuracy
  • 10% or ±5 bpm (whichever is greater)
Heart rate resolution
  • 1 bpm
Heart rate calculation
  • Takes into account last 10 beat-to-beat intervals; excludes min/max intervals
Heart rate meter response time
  • Heart rate changes: 80–120 bpm captured within 8 sec ±2 sec; 80–40 bpm captured within 16 sec ±2 sec
ECG sampling rate
  • 250 samples per second
Applied part classification
  • Defibrillation-proof type CF applied part
Applied current
  • 16 µA (max), 40 kHz current pulse is applied to the patient
Tall T-wave detection
  • Up to 1.5 mV peak to peak is rejected
Pace pulse detection
  • Amplitudes ±2 mV–±700 mV; pulse widths 0.1 ms–2 ms; rise time ≤10% of the pulse width, but ≥100 μs
Device & algorithm performance
  • Meets IEC 60601-2-27:2011, IEC 60601-2-47:2012 and AAMI EC57 for heart rate measurements
Activity level
  • 0 = at rest, 1 = low activity, 2 = moderate activity, 3 = high activity
Ambulation
  • Ambulating or not ambulating
Posture
  • Lying down (left or right side, supine, prone or reclining) or upright***
Data transmission interval
  • 1 minute
Local storage
  • 4 hours
Wireless/Security
Wireless/Security
Radio
  • Bluetooth low energy (4.2)
Frequency band
  • 2402 - 2480 MHz
RF radiated power output
  • Transmit power 0 dBM (1 mW)
Range
  • 100 feet (line of sight)
Modulation scheme
  • Frequency shift keying (FSK)
Security
  • Data in rest: AES 128-bit (ECB mode); Data in transit: AES 128-bit (CCM mode)
Environmental
Environmental
Operating ambient temperature
  • +10°C to +40°C (+50°F to +104°F)
Operating humidity
  • 10 - 95% relative humidity limit (non-condensing)
Operating atmospheric pressure
  • 70 – 102 kPa (10.15 psi – 14.80 psi)
Shipping temperature
  • -20°C – +40°C (-4°F – +104°F); time limit 48 hours
Shipping humidity
  • 5 – 95% relative humidity (non-condensing)
Shipping atmospheric pressure
  • 70 – 102 kPa (10.15 psi – 14.80 psi)
Storage temperature
  • +10°C – +40°C (+50°F – +104°F)
Storage humidity
  • 5 – 95% relative humidity (non-condensing)
Storage atmospheric pressure
  • 70 – 102 kPa (10.15 psi – 14.80 psi)
Shelf life
  • 12 months in individually sealed pouch
Product ordering information
Product ordering information
Biosensor BX100
  • 10 per box
Multi-patient bridge (single Bluetooth router, power supply, USB cable, international wall outlet adapters, mounting plate and screws)
  • 1 per box
Power supply, USB cable and international wall outlet plug adapters
  • 1 per box
Mounting plate and screws
  • 1 per box
  • * Biosensor will collect data up to 115 hours and will attempt to transmit stored data for up to 120 hours. Each patient’s experience will be different; actual operational life and data transmission period may be shorter for some patients.
  • **Biosensor will reject pacemaker pulses and accurately compute heart rate when it detects pacemaker pulses with amplitudes = ±2 mV to = ±700 mV and pulse width = 0.1 ms and amplitudes = ±2 mV but ±50 mV and pulse width = 2 ms (with the exclusion of dual-chamber pacing and pace pulses with tails) Biosensor will indicate that data is invalid when it detects pacemaker pulses with amplitudes = ±100 mV but = ±700 mV and pulse width = 2 ms (with the exclusion of dual-chamber pacing and pace pulses with tails) or ineffectively paced QRS complexes. Philips does not claim, verify or validate support for all available pacemakers.
  • ***Posture accuracy depends on biosensor calibration, which occurs automatically after patient has ambulated for at least 15 seconds
  • † Actual range will vary depending on the Bluetooth backend system to which the biosensor is connected.
  • ¹Philips G10 Biosensor Wear Study, Philips Connected Sensing, 2019.
  • ²Mølgaard RR, Larsen P, Håkonsen SJ. Effectiveness of respiratory rates in determining clinical deterioration. JBI Database System Rev Implement Rep. 2016;14(7):19-27.
  • ³Hogan J. Why don’t nurses monitor the respiratory rates of patients? Br J Nurs. 2006 May-24;15(9):489-92. www.ncbi.nlm.nih.gov/pubmed/16723921.
  • The Philips Biosensor BX100 is not available for sale in all countries. Please contact your local Philips representative for details.