PHILIPS A1 Biosensor BXIOO Wearabte biosensor A.
1
Instructions for use English 2
Contents Conventions 4 Storing the Biosensor 13 Text Formatting 4 Troubleshooting the Biosensor 13 Notes, Cautions, and Warnings 4 Biosensor LED flashes red 13 Rx Only 4 Intended Use 4 Indications for Use 4 Biosensor LED does not flash green when power button is pressed 13 Warnings 5 Cautions 5 Biosensor data does not display/update data in the backend system 13 Introduction to the Philips Biosensor BX100 7 Biosensor is partially adhered to the patient’s chest 14 The Philips Bio
Conventions Text Formatting The following typographical conventions are used in this guide. Typeface Usage Example Bold System keys, user interface text Press the Main Screen key Italic Section titles, document titles Assigning and Applying the Biosensor Notes, Cautions, and Warnings Note — A Note calls attention to an important point in the text. Caution — A Caution calls attention to a condition or possible situation that could damage or destroy the product or the user’s work.
Warnings — • PACEMAKER PATIENTS: The biosensor may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon biosensor. Keep pacemaker PATIENTS under close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument. • Do not use the biosensor on a patient with a known or suspected allergy to adhesives. • Apply the biosensor to healthy, intact skin only.
• The biosensor will not operate outside of the following rhythms: normal sinus rhythm, sinus tachycardia, sinus bradycardia, supraventricular tachycardia, and sinus rhythm with premature (<6 per minute) ventricular complexes. • The biosensor is not intended to discern cardiac arrhythmias or to alarm when arrhythmias are present. • Heart rate values may be inaccurate when pacemaker pulses are present outside of the disclosed pacemaker range. • Do not modify the biosensor.
Note — Read these Instructions for Use first, then follow the Quick Start Guide on the Philips Biosensor BX100 package to apply the biosensor to the patient. Introduction to the Philips Biosensor BX100 The Philips Biosensor BX100 is a small, lightweight, disposable chest-worn biosensor that collects, stores, and wirelessly transmits physiological data to a qualified backend system.
Back of Biosensor 5 6 6 0001AB50012 LED States The following table describes the states of the Philips Biosensor BX100's LED: LED indicator State Indication Steady green for one second Power on The biosensor was turned on. Flashing green Setup in process The biosensor is attempting to connect with the backend system. If the biosensor is not applied to the patient within five minutes, the biosensor automatically turns off.
Assigning and Applying the Biosensor Before you can begin collecting measurement data, you must first pair the biosensor with the backend system and apply the biosensor to the patient’s skin. To assign and apply the Philips Biosensor BX100: Biosensor ID # Biosensor ID # 00:09:FB:B8:30:14 xxxxxxxxxxxxxxxx Biosensor 1.
Note — Do not open the biosensor package until you are ready to use it. 2 1 2 Biosensor ID # Biosensor # 4. Depress the power button for approximately oneID second to 00:09:FB:B8:30:14 xxxxxxxxxxxxxxxx turn on the biosensor. You will feel a "click" when the button is 1 depressed. The LED flashes green, indicating that 2 the biosensor is undergoing the setup process. 2 2 Notes — • If the LED does not flash green after 2-3 tries, discard the biosensor and open a new package.
7. When the biosensor is attached to the patient, the LED displays a steady green light for 20 seconds indicating that the biosensor is communicating with the backend system and is ready for use. If the LED does not display a steady green light, refer to Troubleshooting. Note — If the LED flashes red, the biosensor has experienced a non-recoverable error. Discard the biosensor and open a new package.
Determining the Biosensor's End of Life When the biosensor is two hours or less away from its end of life, it sends a notification to the backend system. For more information, refer to your backend systems' product documentation. Removing the Biosensor Remove the Philips Biosensor BX100 when: • The patient has worn the biosensor for 96 hours or more. • The biosensor indicates to the backend system that it is two hours or less away from its end-of-life shutdown. • The biosensor's LED is flashing red.
Storing the Philips Biosensor BX100 Store biosensors in their sealed pouches until ready for use. Do not open the pouch until you are ready to apply the biosensor. Use immediately after opening to prevent the gel on the back of the biosensor from drying. Do not attempt to reseal the pouch after opening. Store biosensors at: • Temperatures between 10-40 °C • Relative humidity (non-condensing) between 5-95% Do not store biosensors in direct sunlight.
green for 7 seconds. If the LED flashes green, continue with Step 3. If the biosensor LED does not flash green after 2-3 tries, remove the biosensor and apply a new one. See Assigning and Applying the Biosensor and Removing the Biosensor. 3. Ensure that the patient wearing the biosensor is within 25 feet of a Bluetooth router. The biosensor will automatically reconnect within 60 seconds when it is within range of a router. Ensure the biosensor's data properly displays in the backend system.
Specifications Notice Copyright © 2018 Koninklijke Philips N.V., All Rights Reserved Trademark Acknowledgments Philips Biosensor BX100 is a registered trademark of Koninklijke Philips Electronics N.V. Other product names may be trademarks of their respective owners. Manufactured for Philips Medical Systems 2 Canal Park Cambridge, MA 02141 (800) 225-0230 Document Number A-453564752821-2 Rev B Part Number 453564752821 For more information or to reorder, go to www.philips.
Symbols This section explains the symbols that appear on the biosensor and its packaging.
Regulatory and Safety Specifications This Philips product has been tested in a typical configuration as described in these Instructions for Use, and is fully compliant with the standards listed below. EMC and Radio Regulatory Compliance This Philips product complies with relevant international and national law and standards on EMC (electromagnetic compatibility) for this type of product when used as intended.
Equipment Classification (according to IEC 60601-1) According to the type of protection against electrical shock: Internally powered ME equipment According to the degree of protection against electrical shock: Defibrillation Proof Applied Part TYPE CF According to the degree of ingress protection: IP27, Protected against access to hazardous parts and the ingress of solid foreign objects greater than 12.5 mm (0.5 inch); and, protected against the effects of temporary immersion.
Currents Intentionally Applied to Patients The currents intentionally applied to the patient for purposes of respiration, leads-off sensing, or active noise suppression shall not exceed the maximum risk currents specified in IEC 60601-1 8.7. The direct current through any patient electrode connection, with all remaining patient electrode connections attached to a common node, shall not exceed 10.0 µA for any active patient electrode under normal connection (i.e.
Philips Biosensor BX100 Specifications Physical Size (W x H x D) 96 mm x 61 mm x 6.2 mm ±5% (without release liners) Weight 10 g ±10% Battery CR2032, 3V primary cell Memory 1 MB non-volatile flash Robustness Survives shock, vibration, free fall (IEC TR 60721-4-7 Edition 1.
Pace Pulse Detection Pacemaker pulses are detected with amplitudes from ±2 mV to ±700 mV; pulse widths from 0.
22
© 2018 Koninklijke Philips N.V. All rights reserved. Printed in the United States of America. First Printing: December 2018. Part number: 453564752821 Document number: A-453564752821 Rev B www.philips.
