General care

Biosensor BX100

Unobtrusive mobile monitoring for general ward patientsPhilips Biosensor BX100 is a medical grade, battery-operated, wireless biosensor. Designed to support patient mobility, it adheres to the chest and continuously captures, records and transmits heart rate, respiratory rate, posture and activity to a secure server. With information from the biosensor, IntelliVue GuardianSoftware aids clinicians in identifying subtle signs of patient deterioration hours before a potential adverse event and assists in driving early intervention.

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SpecificationsPhysical

Size (W x H x D) 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 and vibration per IEC 60721-4-7; Class 7M2. Survives free fall (1 m drop) per IEC 60601-1

Water ingress protection IP 27 (IEC 60529:2013)

Not manufactured with natural rubber latex

Use

MRI safe No

Single use Yes, single use only

Operational life and data transmission period

Biosensor can be chest-worn up to 120 hours (5 days)*

Disposable Yes

Serviceable No

Performance

Respiration rate measurement rangeRespiration rate between 3 and 40 breaths per minute (when BX100 indicates Ambulating the respiratory rate is set to invalid)

Respiration rate accuracy ±3 rpm (excluding periods of undefined respiration rate due to patient talking, eating or coughing, for example)

Respiration rate resolution 1 rpm

Heart rate measurement range 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 the minimum and maximum intervals• Averages the remaining 8 intervals to compute “mean interval”• Computes 60/mean interval in seconds to convert to bpm

ECG sampling rate 250 samples per second

Response time of heart rate meter to change in heart rate

Inside a reporting interval, instantaneous heart rate changes from:• 80 – 120 bpm shall be captured within 8 seconds with a margin

of +2 seconds• 80 – 40 bpm shall be captured in less than 16 seconds with

a margin of +2 seconds

Applied part classification Defibrillation-proof type CF applied part

* 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.

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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

Pacemaker pulses are detected when amplitudes range from ±2 mV to ±700 mV; pulse widths range from 0.1 ms to 2 ms; and rise time of no less than 10% of the pulse width, but not greater than 100 µs

Pace pulse rejection

Biosensor will reject pacemaker pulses and accurately compute heart rate when it detects pacemaker pulses as noted here:• Amplitudes = ±2 mV to = ±700 mV and pulse width = 0.1 ms• 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.

Device and 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 or upright• Lying down includes lying on left or right side, supine, prone or reclining• Posture accuracy depends on biosensor calibration, which occurs automatically

after patient has ambulated for at least 15 seconds

Data transmission interval 1 minute

Local storage 4 hours

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

Operating ambient temperature range +10°C – +40°C (+50°F – +104°F)

Operating humidity range 10 – 95% relative humidity limit (non-condensing)

Operating atmospheric pressure range 70 – 102 kPa (10.15 psi – 14.80 psi)

Shipping temperature range -20°C – +40°C (-4°F – +104°F) time limit 48 hours

Shipping relative humidity range 5 – 95% relative humidity (non-condensing)

Shipping atmospheric pressure range 70 – 102 kPa (10.15 psi – 14.80 psi)

Storage temperature range +10°C – +40°C (+50°F – +104°F)

Storage humidity range 5 – 95% relative humidity (non-condensing)

Storage atmospheric pressure range 70 – 102 kPa (10.15 psi – 14.80 psi)

Shelf life 12 months in individually sealed pouch

* Actual range will vary depending on the Bluetooth backend system to which the biosensor is connected.

Philips Medizin Systeme Böblingen GmbHHewlett-Packard Str. 271034 Böblingen Germany

© 2020 Koninklijke Philips N.V. All rights are reserved.Philips reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. Trademarks are the property of Koninklijke Philips N.V. or their respective owners.

philips.com

Printed in the Netherlands. 4522 991 53171 * APR 2020

Product number Product description QuantityBiosensor BX100

989803203011 Philips Biosensor BX100 10 per box

Multi-patient bridge

989803200081

Multi-patient bridge (single Bluetooth router, power supply, USB cable, international wall outlet adapters, mounting plate and screws)

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Accessories

989803204131 Power supply, USB cable and international wall outlet plug adapters 1

989803204141 Mounting plate and screws 1

Product ordering information

Philips Medical Systems3000 Minuteman RoadAndover, MA 01810-1099USA

Multi-patient bridge for seamless data transmission

Multiple patients• Connection of up to 16 biosensors per router• Continuous connection while patient is ambulating

Efficient workflow• No cleaning or charging required• Installed by Philips

Long range connectivity• 30 m (100 ft) line of sight

Flexibility• POE and wall plug• Ethernet cable and Wi-Fi (2.4 GHz/5 GHz)

User-friendly dashboard• Router connection/performance status• Software upgrades Access controller dashboard