Philips G5 solution Instructions For Use Manual
G5 Solution
Wearable biosensor
Instructions
for use
989803199491
2
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
conguration 19
Notications 19
Reviewing data 22
Maintenance 23
Cleaning and disinfection 23
Storage 23
Troubleshooting 24
Specications 26
Symbols 26
Manufacturer’s
information 27
Open source software 27
Regulatory and safety
specications 27
EMC and radio regulatory
compliance 28
FCC compliance statement 29
Safety and
performance tests 30
Biosensor specications 34
Software application
specications 35
Contents
3
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 congurable.
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 conguring 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.
4
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
oine 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
5
Front of biosensor
2
1
2
4
3
5
6
1
2
1
0001AB50012
88
7
Back of biosensor
6
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:
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-congurable between 1 to 30 minutes
G5 biosensor battery level
Date and time
Reporting interval
Notications log
7
Application dashboard
12
9
10
11
13
14
8
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 inamed
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’ notication
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
9
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 conrmatory,
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 modication 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 debrillation
proof. Remove the biosensor
from the chest if the biosensor
is located on the area where
debrillation 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.
10
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 aect
the operation of other nearby
electronic devices. Additionally,
other electronic devices should
not aect 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 benets 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
11
Wireless to the compatible
mobile device.
Customer network security and
importance of security policy
• Ensure there are sucient
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 identied risks),
and so on.
• Operational security; for
example, access/authorization
controls, change management,
and network segmentation
based on data classication.
Auto-lock settings
• Philips recommends that you
congure 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
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