Philips G5 solution Instructions For Use Manual

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G5 Solution

Wearable biosensor

Instructions for use

989803199491

Introduction 3

Intended use 3

Product description 4

General warnings

and precautions 8

Warnings 8

Precautions 9

Use environment 9

Radiofrequency

interference 10

Security and privacy

recommendations 10

Product operation 12

Product setup 12

Preparing skin and

applying biosensor 12

Connecting to the

G5 application 14

Disconnecting the biosensor

and saving patient data 16

Biosensor interface 18

G5 application interface 19

Heart rate transmission

conguration 19

Notications 19

Reviewing data 22

Maintenance 23

Cleaning and disinfection 23

Storage 23

Troubleshooting 24

Specications 26

Symbols 26

Manufacturer’s

information 27

Open source software 27

Regulatory and safety

specications 27

EMC and radio regulatory

compliance 28

FCC compliance statement 29

Safety and

performance tests 30

Biosensor specications 34

Software application

specications 35

Contents

Introduction

Intended use

Philips wearable biosensor-G5 solution is a single-location, chest-

worn heart rate monitor. The wearable biosensor-G5 solution includes

a wearable biosensor-G5 and software application. The wearable

biosensor-G5 is a single-use device measuring 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 functions by capturing and then sending

physiological data wirelessly to the software application. The biosensor’s

frequency of data collection and transmission is congurable.

The software application is a single-patient use device, intended as

an accessory to the biosensor to display and store physiological and

operational data. The software application receives and displays data

from the biosensor providing a user interface and exportable le for

retrospective review and analysis. The application allows conguring the

biosensor frequency of data collection and transmission.

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. 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. 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

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. Heart

rate measurements are sent to a compatible device using a USB cable for

oine review and analysis.

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 upon a combination of patient’s

single-vector ECG and their motion data. The biosensor has two days of

wear life, after which it turns o automatically.

Biosensor top cover

Biosensor label

LED light

ON button

Release liner 1

Release liner 2

Biosensor ID on the back

of the release liner

Electrodes

Front of biosensor

0001AB50012

Back of biosensor

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 le and displays the following:

• 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-congurable between 1 to 30 minutes

G5 biosensor battery level

Date and time

Reporting interval

Notications log

Application dashboard

Warnings

• Do not use the biosensor during MRI procedures.

The biosensor is MRI unsafe.

• Do not use the biosensor during X-ray. The biosensor 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 biosensor if it no longer sticks rmly to the skin. The biosensor must be properly adhered to the patient to obtain signal from the body.

• Do not use if hydrogel is dry. Keep biosensor in sealed package. Only open immediately before use to prevent hydrogel from drying.

• Biosensor is for single use only. Do not reuse due to risk of cross-infection, degradation of adhesive or electrical performance.

• Do not apply over open wounds, lesions, infected, irritated, scarred or inamed areas. The biosensor should only be applied to intact skin.

General warnings and precautions

• Do not apply to patients with a history of known tape or adhesive allergy. The biosensor contains an adhesive which adheres to the skin.

• Warning pacemaker patients:

Biosensor can detect a patient’s pacemaker pulses. 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 the G5 application interface section of this manual for disclosure of the pacemaker pulse detection capability of the biosensor.

• Warning pacemaker patients:

Biosensor can detect a patient’s pacemaker pulses. Do not use the biosensor for rejecting pace pulses. A ‘pacepulse detected’ notication will appear whenever interrupted measurements occur. The heart rate value will not display during a detected pacing event.

• Do not use the biosensor simultaneously with the cardiac monitors or cardiac

telemetry devices. Cardiac monitors or cardiac telemetry devices in direct contact with the thorax may degrade the biosensor signal quality or produce erroneous results. This potential interaction has not been evaluated.

• Do not use the device for diagnosis. Whenever patient condition does not match values, take a conrmatory, 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 modication of this equipment is allowed.

Precautions

• Only apply the biosensor over clean and dry skin. Do not apply the biosensor over body hair. Remove any oil, lotion, residue, or debris from skin before application.

• Use caution when removing biosensor to prevent skin irritation. Gently swab area under the biosensor with water as you are removing the sensor.

• To frequently collect instantaneous heart rate, assess the 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 debrillation proof. Remove the biosensor from the chest if the biosensor is located on the area where debrillation pads need to be applied.

• Heart rate value may be lower or higher with patients with arrhythmia.

• Heart rate value 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 biosensor to avoid potential performance degradation.

General warnings and precautions

Use environment continued

• Keep biosensor pouch sealed until the biosensor is ready for use.

• The biosensor should not be exposed to more than three showers. Each shower should not be longer than 10 minutes long, and the water temperature should not be higher than 105°F.

• The biosensor should not be worn during baths or submerged under water.

• The biosensor’s adhesive should not be handled directly with the ngers once the liners have been removed.

• The biosensor should not be subjected to aggressive mechanical handling (e.g. twisting, pulling, etc.) during setup.

• The biosensor should be disposed according to hospital’s disposable electronic devices guidelines after its use.

Radiofrequency interference

If interference problems occur, try moving biosensor away from the source of the interference. You can also move the electronic device or its antenna to another location to solve the problem. These guidelines help ensure that the biosensor will not aect the operation of other nearby electronic devices. Additionally, other electronic devices should not aect the use of the biosensor.

Security and privacy recommendations

Customer’s role in the product security partnership

Security of Philips products

is an important part of each

facility’s overall security strategy.

However, these benets can only

be realized in combination with

a comprehensive, multi-layered

strategy that includes policies,

procedures, and technologies to

protect information and systems

from external and internal threats.

In accordance with security and

industry best practices, 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 there are sucient

intrusion prevention and

detection measures as part of

the IT security policies.

• The mobile device should

not be connected to the

hospital network.

• It is recommended to have anti-

virus or malware on the mobile

device.

• Philips recommends operating

Biosensor in secure network by

turning o the Wi-Fi connectivity

on the mobile device running

the G5 App. Connectivity of G5

app with biosensor shall only

be established on Bluetooth

protocol (Version 4.2).

• If Wi-Fi cannot be disabled on

the mobile device, it is advised

to connect on a highly secure

wireless network (e.g. WPA2)

with strong password enabled.

User account maintenance

• Do not share the G5 App

password with any unauthorized

personnel.

• Use physical security; for

example, locks, cameras,

keycards, sensors, and so on,

to restrict unauthorized access

of mobile device.

• Use procedural security; for

example, unattended mobile

device locking, no sharing of

access credentials, termination

checklists, risk management (that

is, performing risk assessments

and mitigating identied risks),

and so on.

• Operational security; for

example, access/authorization

controls, change management,

and network segmentation

based on data classication.

Auto-lock settings

• Philips recommends that you

congure the mobile device

auto-lock time to match the

security policies (Permissible is

between 1-9 minutes).

Application

• Philips recommend that G5

application should only be used

with a compatible mobile device.

– Any unnecessary applications

should be removed 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

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.

• Do not use alcohol for cleaning purposes because it dries the

skin and may diminish electrical ow. Alcohol may also increase

likelihood of skin irritation.

• Do not apply the biosensor to patients with skin integrity issues.

Only apply the biosensor to intact skin.

• Do not apply the biosensor over visible scars.

• Do not apply the biosensor to patients with known allergies

to tape or adhesives.

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 ow.

d Let skin dry.

Note: Thorough cleaning and drying of the skin can improve

biosensor adhesion.

Note: Skin prep solution may be applied to patients with delicate skin

to make removal easier later.

3 Prepare biosensor

a To open the package, pull the two silver layers apart.

b Carefully remove the biosensor from the package.

c Examine 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.

d Turn on the biosensor by pressing the ON button .

e A green light will ash, 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.

Product operation

4 Apply biosensor

a Without touching the adhesive, remove release liner (1).

b Apply the biosensor to the patient’s upper left chest, over the heart.

c Apply pressure on the biosensor evenly across the applied side.

d Without touching the adhesive, remove release liner (2).

e Press rmly over the entire biosensor to ensure it is fully adhered to

the skin.

Note: If the biosensor does not adhere properly or if it falls o after

application, remove it and replace with a new one.

Note: 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

a Open the app on the mobile

device by tapping the icon

for the 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.

b Enter the new password in the New Password and Conrm New

Password elds. During login, the app will oer 4 opportunities to

enter the correct password before the app terminates itself.

Note: Do not forget your password, as without it any data collected with

the app will not be recoverable.

c Enter patient ID (required) and patient assignment information

(optional). Select Save and Connect to G5 Biosensor.

Note: Do not enter patient’s medical record number (MRN) or patient’s

name as patient ID.

Note: The alphanumeric Biosensor ID can be found on the biosensor package, underneath the square QR code labeled Biosensor ID.

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).

e Tap Connect if 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.

Note: The biosensor pairing process is not instantaneous. It may take

a little time.

Note: If the app could not connect to the selected biosensor, verify whether

the correct biosensor was selected. If not, select the correct biosensor.

f Once the biosensor has successfully connected with the app, the

app dashboard will be displayed. The green light on the biosensor

will become steady and will stay on for 20 seconds, and then turn

o automatically.

g Visually conrm that the heart rate measurement is displayed on

the app. Now the biosensor is properly set up.

h 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 the troubleshooting steps.

Note: In the event the biosensor is out of range of the app, it will

automatically reconnect with the app when it is in range again.

Product operation

Disconnecting biosensor and saving patient data

Note: Use caution when removing biosensor to prevent skin irritation.

Take care not to pull the hair or skin. An adhesive tape remover may help

with removal.

Note: Dispose of the biosensor according to local laws for battery

operated electronics and hospital guidelines.

1 Disconnect biosensor and begin exporting patient data

a Tap menu on top right of

the app dashboard screen.

Select Disconnect, Save and

Exit.

b Using a USB cable, plug

the mobile device into the

computer where patient data

will be stored. Click Next to

proceed.

c Tap Disconnect and Export

Data on app screen. This will

disconnect the G5 biosensor,

if one is paired, and begin

the process of exporting the

patient’s data.

Note: You must continue with step 2

in order to save the patient’s data.

2 Save patient data on computer

• 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

• If this folder is empty, wait until the le export has completed.

• Click on the zip le. This will open a new window.

• Click on the ‘export’ folder.

• This will display a few Excel les. Highlight the Excel le that starts

with “G5_RAW”

• Click “extract to”

• Click “OK”

• Enter the password that you created for the app

The les are now saved to the computer’s desktop for future review.

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 for viewing patient data.

3 Clear data from app and exit

Note: Be sure to exit the app to

delete the patient’s files on the

mobile device.

a Tap Clear Data and Exit. This

will clear out all patient data

from the app and exit the

application.

4 Remove biosensor from patient

a Gently peel each side of the biosensor one at a time, leaving the

center adhered. Gently swab with water while removing the device.

b Gently peel the center of the biosensor from top to bottom, until the

entire surface becomes loose and comes o.

c Use adhesive tape remover if necessary.

Note: If the same patient requires another biosensor, repeat steps on

page 12 for setup and connection of 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 ashing 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 ashes 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 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

• Biosensor battery status

• Notications

Heart rate transmission conguration

The frequency of data collection

and transmission is clinician-

congurable. Transmission

intermittence period can be

adjusted from 1 minute to 30

minutes. The biosensor will store

data locally up to 4 hours.

Notications

‘No connection’

No Connection notication will be

displayed whenever biosensor is

not connected with the app.

NoConne ction:  The biosensor isnot connect ed tot heapp. Ensure t he biosensor and mobile device a rene are achot her.Ift hat doesnot w ork, see theTrouble shooting section of the Instr uctions forUse.

Noc onnect ion

Notications continued

‘Pace pulse detected’

The Philips biosensor-G5 can

detect a patient’s pacemaker

pulses. Pace pulse detection is

used to ag, not reject, pacing

events. Pacemaker pulses are

detected when amplitudes from

±2mV to ±700mV; pulse widths

from 0.1ms to 2ms; and rise time

of 10% of the pulse width, but not

greater than 100μs are present.

‘Leads o’

Leads o notication is displayed

on the app when the biosensor

does not have appropriate

electrical contact with the skin.

Press down rmly on the device to

see if the notication is resolved.

If the notication 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). Whenever the heart rate

value calculated outside of this

range, a notication will indicate

Out of Range.

G5 application interface

Normal

HROut -of-Range

HROut ofR ange: Thebiosensor c andete ct heartratefrom30-220bpm. Theca lculat ed heart rate valueisout side oft hisra nge. Takea confirmat ory,in dependent c heckof vitals.

Normal

Norma l

PacePulseDetected:Thebiosensor candetect apat ient’s pac emake rpulses. Pa cepulse  detec tion is usedt oflag ,not reje ct, pac ing event s. No act ioni sne cessa ry.

Norma l

Leads Off:The biosensor does nothave sufficient electricalc ontactwith the patie nt’sskin. Pr essdown firml yon the device. Ifthis notifica tion continues, remove andre place the biosensor.

‘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’

The biosensor will send low battery

notication in the event the battery

level falls below the normal level.

‘Biosensor error’

The biosensor has detected

system error that will be displayed

under notication log. Refer to

biosensor troubleshooting section

for next steps.

Norma l

Biosensor Error :T hebiosensor has detec ted asystemerror.RefertotheTroubleshooting section of the Instr uctions forUse.

Low

LowB att ery: Thebiosensor ba tte ryhas fallenbelowthenormallevel.Remove and repla cet hebiosensor, ifne cessar y.

Reviewing data

The G5 software application provides the ability to export a le for

retrospective review and analysis on a computer.

The le 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. 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 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.

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 ashes, the

biosensor was not previously turned on.

• If no light ashes,

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

• Close the app, turn the mobile device Short Range Wireless o

and on and re-launch the app and proceed to connect biosensor

to the app.

• 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 biosensor won’t properly adhere to the patient’s chest

• If you touched a large area of the adhesive, you may need to dispose of

the biosensor and apply a new one.

• Before applying a new biosensor to the patient’s chest, ensure the skin

is clean of any oil, lotion, debris or residue and the area is completely dry.

• Press rmly 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 ashes, the

biosensor was not previously turned on.

• If no light ashes,

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

• Close the app, turn the mobile device Short Range Wireless o

and on and re-launch the app and proceed to connecting biosensor

to the app.

• 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 ashing 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 to see if the biosensor has a red ashing light.

• If the red light is ashing, remove and replace the biosensor.

• If there is no red light ashing, press down rmly 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

• Ta p Cancel to return to the biosensors in the range screen.

• Enter the patient information and select 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 dierent area of the

upper left chest to avoid further irritating the patient’s skin.

• If skin irritation persists, discontinue use.

Symbols

Do not reuse

Non-ionizing radiation

Manufacturer

Use by date

Batch code

Caution

MR unsafe

Debrillation Proof Type CF Applied Part (Entire G5 biosensor is an applied part)

Read instructions for use

Do not use if package is damaged

Prescription use only

Storage humidity range limits

Storage temperature range limits

Box of 5

Protected against access to hazardous parts and the ingress of solid foreign objects greater than

12.5mm (0.5 inch); and, protected against eects of temporary immersion.

Catalogue number

Specications

Storage ambient pressure range limits

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 oce at

www.healthcare.philips.com

Open source software

Following is a list of software used for the development of G5 Application.

Title Description Version Vendor

Zip4j Password protect the

exported data

1.2.4 net.lingala

OpenCSV Library to create CSV les 4.0 OpenCSV

Android SDK

Platform to build and run Android apps

API25 Google

Butterknife Annotation processing 8.8.1 Square

Regulatory and safety specications

This Philips product has been tested in a typical conguration 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.

• 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.

Specications

Regulatory and safety specications continued

• 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 law

and standards on EMC (electromagnetic compatibility) for this type of

product when used as intended. Such laws and standards dene both the

permissible electromagnetic emission levels from product and its required

immunity to electromagnetic interference from external sources.

Other electronic products exceeding the limits dened in such EMC

standards could, under unusual circumstances, aect the operation of the

product.

• Medical electrical products needs special precautions regarding

EMC, and needs to be installed and put into service according to EMC

information provided in this Instructions for use.

• The use of accessories and cables other than those specied, may

result in increased emission or decreased immunity levels.

• The product should not be used adjacent to or stacked with other

products and that if adjacent or stacked use is necessary, it should be

observed to verify normal operation.

FCC compliance statement

Caution: Changes or modications 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 and

2 this device must accept any interference received, including

interference that may cause undesired operation.

Changes or modications 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 classication (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:

Debrillation 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 eects 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.

Specications

Guidance and manufacturer’s declarationelectromagnetic emissions

The Philips wearable biosensor-G5 Solution is intended for use in the

electromagnetic environment specied 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 declarationelectromagnetic immunity

The Philips wearable biosensor-G5 Solution is intended for use in the

electromagnetic environment specied 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

Electromagnetic Environment Guidance

Floors should be wood, concrete or ceramic tile. If oors 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 eld IEC 61000-4-8

30 A /m 30 A /m

Electromagnetic Environment Guidance

Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Specications

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

Electromagnetic Environment Guidance

Portable and mobile RF communications equipment should not be used no 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 xed RF transmitters, as determined by an electromagnetic site survey,a 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 aected by absorption and reection from structures, objects and people.

a 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.

Specications

Biosensor specications

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 ash

Robustness Survives shock, vibration, free fall,

and bump

Ingress Protection IP27

Manufactured with Latex No

Use

MRI Safe No

Singe 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-tobeat 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 dened 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)

Debrillator-Proof Debrillator has no adverse eects 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 specications

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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Philips G5 solution Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual