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Philips G5 solution Instructions For Use Manual

Wearable biosensor
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  • Page 2 G5 Solution Wearable biosensor Instructions for use 989803199491...

  • Page 3: Table Of Contents

    Contents Introduction Maintenance Intended use Cleaning and disinfection Product description Storage General warnings Troubleshooting and precautions Specifications Warnings Symbols Precautions Manufacturer’s Use environment information Radiofrequency Open source software interference Regulatory and safety Security and privacy specifications recommendations EMC and radio regulatory Product operation compliance Product setup...

  • Page 4: Introduction

    The Philips wearable biosensor-G5 is indicated for single patient use whenever heart rate measurement is needed in non-critical hospital settings. The Philips wearable biosensor-G5 solution is used as a higher resolution heart rate log by nurses or physicians retroactively as an aid in making non-critical or non-life threatening therapeutic decisions.

  • Page 5: Product Description

    Product description Biosensor Philips wearable biosensor-G5 solution is a patient heart rate sensing system – comprised of a Philips wearable biosensor-G5 and a software application G5 application – which gathers, stores and displays a patient’s heart rate. The biosensor G5 is designed to connect with the G5 application to let clinicians review and export patient heart rate.
  • Page 6 Front of biosensor Back of biosensor 0001AB50012...
  • Page 7 Product description Application G5 software application is an Android-based application for mobile devices. The app receives patient’s heart rate data, exports data into a password-protected file and displays the following: Menu • Disconnect biosensor and exit • Clear all data and exit Heart rate (instantaneous) Instantaneous heart rate is measured every beat over the reporting interval, which is user-configurable between 1 to 30 minutes...
  • Page 8 Application dashboard...

  • Page 9: General Warnings And Precautions

    General warnings and precautions Warnings • Do not use the • Do not apply to patients biosensor during with a history of known MRI procedures. tape or adhesive allergy. The biosensor is MRI unsafe. The biosensor contains an adhesive which adheres •...

  • Page 10: Precautions

    • Only apply the biosensor over Use environment clean and dry skin. Do not apply the biosensor over body • The G5 solution is intended hair. Remove any oil, lotion, for non-critical care hospital residue, or debris from skin environments.

  • Page 11: Radiofrequency Interference

    Customer’s role in the product • The biosensor’s adhesive security partnership should not be handled directly Security of Philips products with the fingers once the liners is an important part of each have been removed. facility’s overall security strategy.
  • Page 12 • It is recommended to have anti- based on data classification. virus or malware on the mobile Auto-lock settings device. • Philips recommends that you • Philips recommends operating configure the mobile device Biosensor in secure network by auto-lock time to match the...

  • Page 13: Product Operation

    Product operation Product setup 1 Gather required materials a Materials needed to prep the skin and trim excessive body hair. b G5 biosensor. c Mobile device with G5 software application (app) installed. Preparing skin and applying biosensor Warning • Do not use the biosensor during MRI procedures. The biosensor is MRI unsafe.
  • Page 14 2 Prepare patient’s skin a Locate the upper left chest area (over the heart) for biosensor application. b Shave or cut hair from electrode sites since excessive hair prevents good electrode contact. c Clean each site thoroughly with soap and water or use an alcohol- free wipe to improve electrical flow.

  • Page 15: Connecting To The G5 Application

    G5 software app. Note: G5 app will be loaded on the customer supplied mobile device by Philips Field Service. Note: The app will prompt you to enter your password after logging in for the first time.
  • Page 16 d Select the patient’s Biosensor ID from the list of biosensors displayed. Scroll down, if applicable, to ensure all biosensors in the range are visible. If the biosensor does not appear, proceed to the troubleshooting steps (page 24). Note: The alphanumeric Biosensor ID can be found on the biosensor package, underneath the square QR code labeled Biosensor ID.

  • Page 17: Disconnecting The Biosensor And Saving Patient Data

    • On the computer, click on the folder icon in the toolbar. • On the left hand side of the window, click on “Samsung” • Navigate through the folders: Android > Data > com.philips. cs.g5.android > Files > Export...
  • Page 18 • If this folder is empty, wait until the file export has completed. • Click on the zip file. This will open a new window. • Click on the ‘export’ folder. • This will display a few Excel files. Highlight the Excel file that starts with “G5_RAW”...

  • Page 19: Biosensor Interface

    Biosensor interface The biosensor interface consists of a one-time ON button and LED light. The LED light indicates the status of the device. LED Behavior Meaning Action Required Green flashing Biosensor ON/Setup Continue with setup in process Steady green for 20 Setup complete None.

  • Page 20: G5 Application Interface

    G5 application interface The app dashboard will display the following in addition to the heart rate: • Biosensor ID of connected G5 biosensor • Patient ID of assigned patient • (Optional) patient assignment information of assigned patient • Date and time of displayed heart rate •...
  • Page 21 G5 application interface Notifications continued ‘Pace pulse detected’ The Philips biosensor-G5 can detect a patient’s pacemaker pulses. Pace pulse detection is used to flag, not reject, pacing Normal events. Pacemaker pulses are detected when amplitudes from ±2mV to ±700mV; pulse widths from 0.1ms to 2ms;...

  • Page 22: Low Battery

    ‘Heart rate invalid’ The biosensor may detect a noise in the signal or another error which may cause the heart rate to be invalid. This may occur when a patient is moving, and the activity could impact the heart rate value. ‘Low battery’...

  • Page 23: Reviewing Data

    Reviewing data The G5 software application provides the ability to export a file for retrospective review and analysis on a computer. The file must be unlocked (using the same password that was used on the G5 biosensor app) to review and analyze the data. Time-stamped heart rate data and notifications are listed in the file.

  • Page 24: Maintenance

    Maintenance Cleaning and disinfection The biosensor is a disposable, single use device. Do not reuse the biosensor. After use, the biosensor is considered non-biohazardous waste and should be discarded according to hospital guidelines and local laws for battery operated electronics. Refer to the instructions for use for the mobile device for cleaning and disinfection procedures.

  • Page 25: Troubleshooting

    Troubleshooting The patient’s heart rate is not displayed in the software app • Press the ON button on the biosensor. If the green light flashes, the biosensor was not previously turned on. • If no light flashes, • Ensure the biosensor and the mobile device are next to each other. •...
  • Page 26 • If this does not resolve the issue, close the app, restart the mobile device and attempt to connect to the biosensor. • If this does not resolve the issue, remove the biosensor and replace with a new one. The red light is flashing on the biosensor •...

  • Page 27: Specifications

    Specifications Symbols Do not reuse Read instructions for use Do not use if package is Non-ionizing radiation damaged Manufacturer Prescription use only Use by date Catalogue number Storage humidity Batch code range limits Storage temperature Caution range limits Storage ambient MR unsafe pressure range limits Defibrillation Proof...

  • Page 28: Manufacturer's Information

    8.8.1 Square Regulatory and safety specifications This Philips product has been tested in a typical configuration as described in this Instructions for Use, and are fully compliant with the standards listed below. • EN IEC 60601-1:2006, EN IEC 60601-1:2006/A1:2013, General requirements for basic safety and essential performance.

  • Page 29: Emc And Radio Regulatory Compliance

    • ANSI/AAMI/ISO EC12:2000/®2010 Disposable electrodes 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. Such laws and standards define both the permissible electromagnetic emission levels from product and its required immunity to electromagnetic interference from external sources.

  • Page 30: Fcc Compliance Statement

    FCC compliance statement Caution: Changes or modifications not expressly approved could void your authority to use this equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: this device may not cause harmful interference and 2 this device must accept any interference received, including interference that may cause undesired operation.
  • Page 31 Specifications Equipment classification (according to IEC 60601-1) According to the type of Internally powered ME protection against electrical equipment shock: According to the degree of Defibrillation Proof Applied Part protection against electrical TYPE BF shock: According to the degree of ingress IP27, Protected against access protection: to hazardous parts and the...
  • Page 32 Guidance and manufacturer’s declaration- electromagnetic emissions The Philips wearable biosensor-G5 Solution is intended for use in the electromagnetic environment specified below, and the customer or the user should assure that it is used in such an environment. Emission Test Compliance...

  • Page 33: Electromagnetic Immunity

    Specifications Guidance and manufacturer’s declaration- electromagnetic immunity The Philips wearable biosensor-G5 Solution is intended for use in the electromagnetic environment specified below. The customer or the user of the Philips wearable biosensor-G5 Solution should assure that it is used in such an environment.
  • Page 34 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Philips wearable biosensor-G5 Solution is used exceeds the applicable RF compliance level above, the Philips wearable biosensor-G5 Solution should be observed to ensure normal operation.

  • Page 35: Biosensor Specifications

    Specifications Biosensor specifications Hardware Size (W x H x D) 100mm x 69mm x 6.2mm ±5% (without the release liners) Weight 12 g ±10% Battery CR2032, 3V primary cell Memory 1MB non-volatile flash Robustness Survives shock, vibration, free fall, and bump Ingress Protection IP27 Manufactured with Latex...

  • Page 36: Software Application Specifications

    Defibrillator-Proof Defibrillator has no adverse effects on biosensor Applied Current 29.1 μA (max), 32 kHz current pulse is applied to the patient Tall T Wave Rejection Up to 1mV peak to peak will be rejected Wireless Radio Bluetooth Low Energy (4.2) Transmission 1-30 minutes (programmable) Local Storage...
  • Page 37 © 2018 Koninklijke Philips N.V. All rights reserved. Printed in the United States of America. First printing: January 2018 Part Number: 453564741671 Artwork: A-453564741671-2 Rev B www.philips.com...

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