Philips G5 solution Manuale utente

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 ‘pace-

pulse 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.

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