Biosensor BX100

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

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)

Usage specifications

Usage specifications

MRI safe	No
Single use	Yes, single use only

See all 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