Philips G5 Solution Wearable Biosensor

Instructions for Use

Part Number: 989803199491

Introduction

Intended Use

The Philips wearable biosensor-G5 solution is a single-location, chest-worn heart rate monitor. It includes a wearable biosensor-G5 and a software application. The biosensor-G5 is a single-use device that measures heart rate by continuously acquiring surface electrical waveforms related to cardiac excitations and measuring beat-to-beat intervals when a patient is stationary or ambulatory. The biosensor captures and wirelessly sends physiological data to the software application. The biosensor's frequency of data collection and transmission is configurable.

The software application is a single-patient use device, intended as an accessory to the biosensor to display and store physiological and operational data. It receives and displays data from the biosensor, providing a user interface and an exportable file for retrospective review and analysis. The application allows configuring the biosensor's data collection and transmission frequency.

Indications for Use

The Philips wearable biosensor-G5 is indicated for single patient use whenever heart rate measurement is needed in non-critical hospital settings. It serves as a higher resolution heart rate log for nurses or physicians, aiding in making non-critical or non-life threatening therapeutic decisions. The biosensor is intended for patients who are 18 years of age or older.

Note

Before using this product to obtain heart rate, carefully read the instructions for use and the quick start guide on the G5 biosensor package.

Product Description

Biosensor

The Philips wearable biosensor-G5 solution is a patient heart rate sensing system comprising a Philips wearable biosensor-G5 and a G5 software application. It gathers, stores, and displays a patient's heart rate. The biosensor G5 connects with the G5 application, allowing clinicians to review and export patient heart rate data. Heart rate measurements are sent to a compatible device using a USB cable for offline review and analysis.

The Philips wearable biosensor-G5 is a wireless, single-use, single-location chest-worn device that acquires surface electrical waveforms related to cardiac excitations and measures beat-to-beat intervals. The biosensor calculates patient heart rate based on a combination of the patient's single-vector ECG and their motion data. The biosensor has a wear life of two days, after which it turns off automatically.

Biosensor Components:

  • 1: Biosensor top cover
  • 2: Biosensor label
  • 3: LED light
  • 4: ON button [⏻]
  • 5: Release liner 1
  • 6: Release liner 2
  • 7: Biosensor ID on the back of the release liner
  • 8: Electrodes

Diagram Description: The document includes diagrams illustrating the front and back of the biosensor, showing the numbered components and their placement.

Application

The 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:

  • 9. Menu: Options include 'Disconnect biosensor and exit' and 'Clear all data and exit'.
  • 10. Heart rate (instantaneous): Instantaneous heart rate is measured every beat over the reporting interval, which is user-configurable between 1 to 30 minutes.
  • 11. G5 biosensor battery level
  • 12. Date and time
  • 13. Reporting interval
  • 14. Notifications log

Diagram Description: The document shows screenshots of the G5 Biosensor Dashboard application, illustrating the interface elements like Heart Rate, Reporting Interval, and Notifications.

General Warnings and Precautions

Warnings

  • Do not use the biosensor during MRI procedures; it is MRI unsafe.
  • Do not use the biosensor during X-ray as it will obstruct the view of an X-ray of the chest.
  • The biosensor should only be used under direct supervision of a licensed physician or healthcare provider, according to the hospital standard of care.
  • Do not use for more than 48 hours. Replace the biosensor if it no longer sticks firmly to the skin. Proper adherence is required to obtain a signal from the body.
  • Do not use if the hydrogel is dry. Keep the biosensor in its sealed package and open immediately before use to prevent hydrogel drying.
  • The biosensor is for single use only. Do not reuse due to the risk of cross-infection, degradation of adhesive, or electrical performance.
  • Do not apply over open wounds, lesions, infected, irritated, scarred, or inflamed areas. Apply only to intact skin.
  • Do not apply to patients with a history of known tape or adhesive allergy, as the biosensor contains an adhesive.
  • Warning for pacemaker patients: The biosensor can detect pacemaker pulses and may continue to count the pacemaker rate during cardiac arrest or some arrhythmias. Do not rely entirely on the biosensor. Keep pacemaker patients under close surveillance. Refer to the G5 application interface section for details on pacemaker pulse detection capability.
  • Warning for pacemaker patients: The biosensor can detect pacemaker pulses. Do not use it for rejecting pace pulses. A 'pace-pulse detected' notification will appear for interrupted measurements, and the heart rate value will not display during a detected pacing event.
  • Do not use the biosensor simultaneously with cardiac monitors or cardiac telemetry devices that are in direct contact with the thorax, as this may degrade signal quality or produce erroneous results. This potential interaction has not been evaluated.
  • Do not use the device for diagnosis. If a patient's condition does not match the values, take a confirmatory, independent check of vitals (including 12-lead ECG).
  • Do not use the device to discern abnormal rhythm patterns or for alarms.
  • Do not use the biosensor with high frequency surgical equipment.
  • No modification of this equipment is allowed.

Precautions

  • Only apply the biosensor over clean and dry skin. Do not apply over body hair. Remove any oil, lotion, residue, or debris from the skin before application.
  • Use caution when removing the biosensor to prevent skin irritation. Gently swab the area under the biosensor with water while removing it.
  • To frequently collect instantaneous heart rate, assess biosensor connectivity to the G5 application every 8 hours. If connectivity is lost, the biosensor will store up to 4 hours of data.
  • Keep your mobile device charged at all times.
  • The biosensor is defibrillation proof. Remove the biosensor from the chest if it is located on an area where defibrillation pads need to be applied.
  • Heart rate values may be lower or higher with patients who have arrhythmia.
  • Heart rate values may be higher when pacemaker pulses are present outside of the disclosed pacemaker pulse range.

Use Environment

  • The G5 solution is intended for non-critical care hospital environments.
  • Maintain a minimum separation distance, as described in the EMC section, between portable radiofrequency communications equipment and the biosensor to avoid potential performance degradation.
  • Keep the biosensor pouch sealed until ready for use.
  • The biosensor should not be exposed to more than three showers. Each shower should not be longer than 10 minutes, and the water temperature should not exceed 105°F (40.5°C).
  • The biosensor should not be worn during baths or submerged under water.
  • The biosensor's adhesive should not be handled directly with fingers once liners are removed.
  • The biosensor should not be subjected to aggressive mechanical handling (e.g., twisting, pulling) during setup.
  • The biosensor should be disposed of according to hospital's disposable electronic devices guidelines after use.

Radiofrequency Interference

If interference problems occur, try moving the biosensor away from the source of interference. You can also move the electronic device or its antenna to another location to solve the problem. These guidelines help ensure the biosensor does not affect other nearby electronic devices, and that other electronic devices do not affect the biosensor's use.

Security and Privacy Recommendations

Customer's Role in Product Security Partnership

Security of Philips products is an important part of a facility's overall security strategy. These benefits are realized through a comprehensive, multi-layered strategy including policies, procedures, and technologies to protect information and systems from threats. Security strategies should address:

  • Data Encryption: Heart rate data is encrypted on the biosensor using 128-bit AES and sent via Short Range Wireless to the compatible mobile device.

Customer Network Security and Importance of Security Policy

  • Ensure sufficient intrusion prevention and detection measures are in place as part of IT security policies.
  • The mobile device should not be connected to the hospital network.
  • It is recommended to have anti-virus or malware protection on the mobile device.
  • Philips recommends operating the Biosensor in a secure network by turning off Wi-Fi connectivity on the mobile device running the G5 App. Connectivity should only be established via Bluetooth protocol (Version 4.2).
  • If Wi-Fi cannot be disabled, connect on a highly secure wireless network (e.g., WPA2) with a strong password.

User Account Maintenance

  • Do not share the G5 App password with unauthorized personnel.
  • Use physical security (e.g., locks, cameras, keycards, sensors) to restrict unauthorized access to the mobile device.
  • Use procedural security (e.g., unattended mobile device locking, no sharing of access credentials, risk management) to protect data.
  • Operational security (e.g., access/authorization controls, change management, network segmentation) should be implemented.

Auto-lock Settings

Philips recommends configuring the mobile device auto-lock time to match security policies (between 1-9 minutes).

Application

  • Philips recommends using the G5 application only with a compatible mobile device.
  • Remove any unnecessary applications from the compatible device.
  • For optimal performance, only the G5 app should be running on the device.

Product Operation

Product Setup

1. Gather Required Materials

  • Materials needed to prep the skin and trim excessive body hair.
  • G5 biosensor.
  • 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.
  • Do not use alcohol for cleaning as it dries the skin and may diminish electrical flow, potentially increasing skin irritation.
  • Do not apply the biosensor to patients with skin integrity issues. Only apply to intact skin.
  • Do not apply over visible scars.
  • Do not apply to patients with known allergies to tape or adhesives.

Diagram Description: An illustration shows the correct placement of the biosensor on the upper left chest area of a person, over the heart.

2. Prepare Patient's Skin

  • Locate the upper left chest area (over the heart) for biosensor application.
  • Shave or cut hair from electrode sites, as excessive hair can prevent good electrode contact.
  • Clean each site thoroughly with soap and water or an alcohol-free wipe to improve electrical flow.
  • Let the skin dry.

Note: Thorough cleaning and drying of the skin can improve biosensor adhesion. Skin prep solution may be applied to patients with delicate skin to make removal easier later.

3. Prepare Biosensor

  • To open the package, pull the two silver layers apart.
  • Carefully remove the biosensor from the package.
  • Examine the biosensor for physical damage and liner integrity before setup.

Note: Discard the biosensor and use a new one if the biosensor foam is not intact, if the ON button appears damaged, or if a liner is missing.

  • Turn on the biosensor by pressing the ON button [⏻].
  • A green light will flash, indicating the biosensor is ready for placement on the patient.

Note: If the light does not turn on, use a new biosensor and repeat the previous steps.

4. Apply Biosensor

  • Without touching the adhesive, remove release liner (1).
  • Apply the biosensor to the patient's upper left chest, over the heart.
  • Apply pressure evenly across the applied side of the biosensor.
  • Without touching the adhesive, remove release liner (2).
  • Press firmly over the entire biosensor to ensure it is fully adhered to the skin.

Note: If the biosensor does not adhere properly or falls off after application, remove and replace it with a new one. A quick start guide with instructions for correct biosensor placement is located on the outside of the package.

Connecting to the G5 Application

5. Connect G5 Biosensor to G5 Software Application

  • Open the app on the mobile device by tapping the icon for the G5 software app.
  • Enter the new password in the 'New Password' and 'Confirm New Password' fields. During login, the app offers 4 opportunities to enter the correct password before terminating.
  • Enter patient ID (required) and patient assignment information (optional). Select 'Save and Connect to G5 Biosensor'.

Note: G5 app will be loaded on the customer-supplied mobile device by Philips Field Service. The app will prompt for a password after the first login. Do not forget your password, as unrecoverable data will result. Do not enter patient's medical record number (MRN) or patient's name as patient ID.

  • Select the patient's Biosensor ID from the list of biosensors displayed. Scroll down if necessary to ensure all biosensors in range are visible. If the biosensor does not appear, proceed to troubleshooting steps (page 24).
  • Tap 'Connect' if the G5 biosensor ID and patient ID are correct. If not, tap 'Cancel'.

Note: If the patient ID or Biosensor ID is incorrect, select 'Cancel' to return to the biosensors in the range screen. The biosensor pairing process is not instantaneous and may take time. If the app cannot connect to the selected biosensor, verify the correct biosensor was selected.

  • Once successfully connected, the app dashboard will display. The green light on the biosensor will become steady for 20 seconds, then turn off automatically.
  • Visually confirm that the heart rate measurement is displayed on the app. The biosensor is now properly set up.
  • The default reporting interval is heart rate every 1 minute. Change the reporting interval by clicking 'Change'.

Note: If the app doesn't display heart rate, review troubleshooting steps. If the biosensor is out of range, it will automatically reconnect when it is in range again.

Disconnecting Biosensor and Saving Patient Data

Note: Use caution when removing the biosensor to prevent skin irritation. Take care not to pull hair or skin. An adhesive tape remover may help. Dispose of the biosensor according to local laws for battery-operated electronics and hospital guidelines.

1. Disconnect Biosensor and Begin Exporting Patient Data

  • Tap the menu on the top right of the app dashboard screen and select 'Disconnect, Save and Exit'.
  • Using a USB cable, plug the mobile device into the computer where patient data will be stored. Click 'Next' to proceed.
  • Tap 'Disconnect and Export Data' on the app screen. This will disconnect the G5 biosensor (if paired) and begin exporting the patient's data.

Note: You must continue with step 2 to save the patient's data.

2. Save Patient Data on Computer

  • On the computer, click 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.
  • If this folder is empty, wait until the file export is complete.
  • Click on the zip file to open a new window.
  • Click on the 'export' folder.
  • Highlight the Excel file that starts with "G5_RAW".
  • Click "extract to".
  • Click "OK".
  • Enter the password created for the app.

Note: Use the app login password to open the .zip files for viewing on the computer. See the 'Reviewing data' section on page 22 for additional instructions.

3. Clear Data from App and Exit

Note: Be sure to exit the app to delete the patient's files on the mobile device.

  • Tap 'Clear Data and Exit'. This will clear all patient data from the app and exit the application.

4. Remove Biosensor from Patient

  • Gently peel each side of the biosensor one at a time, leaving the center adhered. Gently swab with water while removing the device.
  • Gently peel the center of the biosensor from top to bottom until the entire surface becomes loose and comes off.
  • Use adhesive tape remover if necessary.

Note: If the same patient requires another biosensor, repeat steps on page 12 for setup and connection of a new biosensor.

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 in process Continue with setup
Steady green for 20 seconds Setup complete None. Biosensor is operating correctly
Flashing red Error Remove and replace biosensor
No light (biosensor broadcasting to app) Biosensor is operational None
No light (biosensor not broadcasting to app) Biosensor is not functional Remove and replace biosensor

If the light on the biosensor flashes red at any time during use, remove the biosensor (see 'Remove biosensor from patient') and replace it with a new one.

G5 Application Interface

The app dashboard displays 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
  • Biosensor battery status
  • Notifications

Heart Rate Transmission Configuration

The frequency of data collection and transmission is clinician-configurable. The transmission intermittence period can be adjusted from 1 minute to 30 minutes. The biosensor will store data locally for up to 4 hours.

Notifications

'No connection'

A 'No Connection' notification will be displayed whenever the biosensor is not connected with the app. Ensure the biosensor and mobile device are near each other. If this does not resolve the issue, see the Troubleshooting section of the Instructions for Use.

'Pace pulse detected'

The Philips biosensor-G5 can detect a patient's pacemaker pulses. Pace pulse detection is used to flag, not reject, pacing events. Pacemaker pulses are detected when amplitudes are from ±2mV to ±700mV, pulse widths are from 0.1ms to 2ms, and rise time is 10% of the pulse width, but not greater than 100µs. No action is necessary.

'Leads off'

A 'Leads off' notification is displayed when the biosensor does not have appropriate electrical contact with the skin. Press down firmly on the device to see if the notification is resolved. If the notification continues, remove and replace the biosensor following the instructions in the Basic operation section.

'Heart rate out of range'

The biosensor can detect heart rate from 30-220 bpm (beats per minute). When the calculated heart rate value falls outside this range, a notification will indicate 'Out of Range'. Take a confirmatory, independent check of vitals.

'Heart rate invalid'

The biosensor may detect noise in the signal or another error that causes the heart rate to be invalid. This may occur when a patient is moving, and activity could impact the heart rate value.

'Low battery'

The biosensor will send a low battery notification if the battery level falls below the normal level. Remove and replace the biosensor if necessary.

'Biosensor error'

The biosensor has detected a system error, which will be displayed under the notification log. Refer to the biosensor troubleshooting section for next steps.

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 used for the G5 biosensor app. Time-stamped heart rate data and notifications are listed in the file. Files are named using patient ID and date. Use any data analysis software program to sort the data by date, as needed.

Maintenance

Cleaning and Disinfection

The biosensor is a disposable, single-use device. Do not reuse it. 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.

Storage

Biosensors must be stored in their sealed pouch. The pouch cannot be resealed after opening. The biosensor should be used immediately after opening the pouch to prevent the hydrogel from drying.

Biosensors should be stored at:

  • Temperature between 15 and 35 °C (59 and 95°F)
  • Humidity between 5 and 95%

Biosensors should not be stored in direct sunlight.

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.
    • Close the app, turn the mobile device's Short Range Wireless off and on, then re-launch the app and proceed to connect the biosensor.
    • If the issue persists, close the app, restart the mobile device, and attempt to connect to the biosensor.
    • If the issue still persists, remove the biosensor and replace it with a new one.

The Biosensor Won't Properly Adhere to the Patient's Chest

  • If a large area of the adhesive was touched, dispose of the biosensor and apply a new one.
  • Before applying a new biosensor, ensure the skin is clean of any oil, lotion, debris, or residue, and the area is completely dry.
  • Press firmly to adhere the sensor to the patient's skin.

The Patient's Heart Rate Does Not Seem to Be Updating

  • Ensure the biosensor and the mobile device are next to each other.

The Biosensor ID is Not Found

  • 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.
    • Close the app, turn the mobile device's Short Range Wireless off and on, then re-launch the app and proceed to connecting the biosensor.
    • If the issue persists, close the app, restart the mobile device, and attempt to connect to the biosensor.
    • If the issue still persists, remove the biosensor and replace it with a new one.

The Red Light is Flashing on the Biosensor

  • The biosensor has a low battery or has an error.
  • Remove and discard the biosensor and replace it with a new one.

The Biosensor Appears Partially Adhered to the Patient

  • Check if the biosensor has a red flashing light. If so, remove and replace the biosensor.
  • If there is no red light flashing, press down firmly on the biosensor to adhere.
  • If the biosensor still does not adhere, remove and replace the biosensor.

The G5 App Shows "Could Not Connect to G5 Biosensor" Message

  • Tap 'Cancel' to return to the biosensors in the range screen.
  • Enter the patient information and select the correct Biosensor ID.

The Biosensor is Causing Skin Irritation

  • Gently remove the biosensor and assess the skin irritation. Treat the area per clinical practice, if needed.
  • Replace the biosensor with a new one, selecting a different area of the upper left chest to avoid further irritating the patient's skin.
  • If skin irritation persists, discontinue use.

Specifications

Symbols

Symbol Description
[No Reuse Symbol] Do not reuse
[Radiation Symbol] Non-ionizing radiation
[Manufacturer Symbol] Manufacturer
[Calendar Symbol] Use by date
[LOT Symbol] Batch code
[Warning Symbol] Caution
[MRI Symbol] MR unsafe
[Defibrillator Symbol] Defibrillation Proof Type CF Applied Part (Entire G5 biosensor is an applied part)
[Info Symbol] Read instructions for use
[Package Damaged Symbol] Do not use if package is damaged
[RX Symbol] Prescription use only
[REF Symbol] Catalogue number
[Humidity Symbol] Storage humidity range limits
[Temperature Symbol] Storage temperature range limits
[Pressure Symbol] Storage ambient pressure range limits
[Box of 5 Symbol] Box of 5
[IP27 Symbol] IP27: Protected against access to hazardous parts and the ingress of solid foreign objects greater than 12.5mm (0.5 inch); and, protected against effects of temporary immersion.

Manufacturer's Information

Connected Sensing – Division of Philips Medical Systems
50 Milk Street
Boston, MA 02109, USA
(800) 225-0230

For more information or to reorder, go to www.philips.com/healthcarestore

Locate your local Philips sales office at www.healthcare.philips.com

Open Source Software

The following is a list of software used for the development of the G5 Application:

Title Description Version Vendor
Zip4j Password protect the exported data 1.2.4 net.lingala
OpenCSV Library to create CSV files 4.0 OpenCSV
Android SDK Platform to build and run Android apps API25 Google
Butterknife Annotation processing 8.8.1 Square

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:

  • EN IEC 60601-1:2006, EN IEC 60601-1:2006/A1:2013, General requirements for basic safety and essential performance.
  • EN 60601-1-2:2015, IEC 60601-1-2:2014, General requirements for basic safety and essential performance.
  • Collateral standards: Electromagnetic Compatibility requirements and test.
  • EN IEC 60601-1-6:2010, General requirements for basic safety and essential performance.
  • Collateral standards: usability.
  • EN ISO 10993-1:2009, EN ISO 10993-1:2009/AC:2010 ISO 10993-1 and Biological Evaluation of Medical Devices
  • EN ISO 10993-5:2009 Biological Information of Medical Devices-Part 5: Test for cytotoxicity
  • ISO 10993-10:2010 Biological Information of Medical Devices-Part 10: Test for irritation and skin sensitization
  • ANSI/AAMI/IEC 60601-2-47:2012, EN 60601-2-47:2001 Particular requirements for the basic safety and essential performance and ambulatory electrocardiographs system.
  • ANSI/AAMI/IEC 60601-2-27:2011, IEC 60601-2-27 Ed 3.0 2011-03 Particular requirements for the basic safety and essential performance of Electrocardiographic Monitoring Equipment
  • ANSI/AAMI/ISO EC57:1998(R)2008, Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithm.
  • ANSI/AAMI/ISO EC12:2000/®2010 Disposable electrodes

EMC and Radio Regulatory Compliance

This Philips product complies with relevant international and national laws and standards on EMC (electromagnetic compatibility) for this type of product when used as intended. These laws and standards define both permissible electromagnetic emission levels from the product and its required immunity to electromagnetic interference from external sources.

Other electronic products exceeding the limits defined in such EMC standards could, under unusual circumstances, affect the operation of the product.

  • Medical electrical products require special precautions regarding EMC and must be installed and put into service according to EMC information provided in these Instructions for Use.
  • The use of accessories and cables other than those specified may result in increased emission or decreased immunity levels.
  • The product should not be used adjacent to or stacked with other products. If adjacent or stacked use is necessary, it should be observed to verify normal operation.

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:

  1. This device may not cause harmful interference.
  2. This device must accept any interference received, including interference that may cause undesired operation.

Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by moving the equipment away and back, the user is encouraged to try to correct the interference by one or more of the following measures:

  • Reorient or relocate the receiving antenna.
  • Increase the separation between the equipment and receiver.
  • Consult the dealer or an experienced radio/TV technician for help.

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 BF
According to the degree of ingress protection: IP27, Protected against access to hazardous parts and the ingress of solid foreign objects greater than 12.5mm (0.5 inch); and, protected against effects of temporary immersion.
According to the mode of operation: Continuous operation
ME equipment Type Body-worn

The device is intended for use in the electromagnetic environment specified below. Given the device's electromagnetic emissions and immunity characteristics, the customer or user should assure that the device is used within such an environment. The following information is mandated by IEC 60601-1-2, the international standard for the electromagnetic compatibility (EMC) of medical electrical equipment.

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 Electromagnetic Environment Guidance
RF Emissions, CISPR 11 Group 1 The Philips wearable biosensor-G5 Solution uses RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions, CISPR 11 Class A The Philips wearable biosensor-G5 Solution is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

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.

Immunity Test IEC 60601 Test Level Compliance Level
Electrostatic discharge (ESD) IEC 61000-4-2 ± 8kV contact
± 15kV air
± 8kV contact
± 15kV air

Electromagnetic Environment Guidance: Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Immunity Test IEC 60601 Test Level Compliance Level
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m

Electromagnetic Environment Guidance: Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Immunity Test IEC 60601 Test Level Compliance Level
Radiated RF IEC 61000-4-3 3 V/m 80-2700 MHz plus intentional radiator requirement Table 9 from 60601-1-2: 2014 3 V/m 80-2700 MHz plus intentional radiator requirement Table 9 from 60601-1-2: 2014

Electromagnetic Environment Guidance: Portable and mobile RF communications equipment should not be used closer to any part of the Philips wearable biosensor G5-Solution, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance is 30cm. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the symbol.

  • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. 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. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Philips wearable biosensor-G5 Solution.

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 No

Use

MRI Safe No
Single Use Yes
Disposable Yes
Serviceable No

Performance

Heart Rate Measurement Range 30-220 bpm (beats per minute)
Heart Rate Accuracy 10% or ±5bpm (whichever is greater)
Heart Rate Resolution 1 bpm
Heart Rate Calculation Heart Rate is calculated:
  • Taking into account last 10 beat-to-beat intervals
  • Excluding the minimum and the maximum intervals
  • Averaging the remaining eight intervals to compute “mean_interval” and
  • Compute 60/mean_interval (in seconds) to convert to bpm
Heart Rate Sampling Rate 250 samples per second
Heart Rate Meter Accuracy and Response to Irregular Rhythm Provides correct heart rates (60, 80, 90, 120 bpm) using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4.1.2.1(e). All QRS are counted with test waveforms within HR accuracy defined above.
Response time of heart rate meter to change in heart rate Inside a reporting interval, instantaneous heart rate change from 80 bpm to 120 bpm shall be captured within 8 seconds (margin of +2 sec).
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 4 hours
Battery Life 4 days
Frequency Band 2402-2480 MHz
RF Radiate Power Output Transmit Power 0dBm(1mW)
Maximum power 8dBm (6.31mW)
Operating Range 10 meters, Line of Sight

Environmental

Operating Temperature Range 15-35 °C
Operating Humidity Range 20-85 %
Operating Atmospheric Pressure Range 10-106 kPa
Storage Temperature Range 15-35 °C
Storage Humidity Range 5-95%
Storage Ambient Pressure Range 50-106 kPa
Shelf Life 3 Months

Software Application Specifications

Mobile Device

Operating System Android OS 7.0 or higher
Compatible Device Smartphone with Bluetooth Low Energy (4.2)
8 GB Storage
1GB RAM

Dashboard Screen

Heart Rate (Instantaneous) bpm (beats per minute)
Reporting Interval 1, 2, 3, 4, 5, 10, 15, 30 minutes

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