LifeWatch FGL-00005 User manual

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LifeWatch Technologies Ltd. Vital Signs Patch (VSP) Gateway
The LifeWatch Technologies Ltd. Vital Signs Patch (VSP) device is
used with the VSP Gateway as part of the VSP System.
Before using the VSP Gateway, please read the sections of this guide
that describe its method of use and operation.
The VSP Gateway model number FGL-00005, FCC ID: SMTLWVGW
The references to gateway within this user guide refer to the VSP
Gateway.
If you have any questions about the use of Vital Signs Patch, please
contact:
Customer Service at:

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Copyright Declaration
Copyright ©2014 LifeWatch Technologies Ltd.® All rights reserved.
LifeWatch Technologies Ltd., LifeWatch Technologies Ltd. logo,
LifeWatch Inc., LifeWatch Inc. logo, Vital Signs Patch System and VSP
are trademarks or registered trademarks
of LifeWatch Technologies Ltd.®.
All other brand names and product names used in this document are trade
names, service marks, trademarks, or registered trademarks of their
respective owners.
The information and screens provided in this manual are subject to
change without notice.
LifeWatch Technologies Ltd. SHALL NOT BE LIABLE FOR TECHNICAL
OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR
FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING
FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS
MATERIAL.
Before using the VSP System please read the Warnings
and Precautions in Appendix A.

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Declaration of Conformity
LifeWatch Technologies’ Quality System (QS) is certified
toISO-9001:2008, ISO 13485:2003
CE 93/42 MDD and Canadian QS Requirements
WARNING
No modification of this equipment is allowed.
Refer servicing to qualified personnel only.
Equipment not suitable for use in the presence of flammable
anesthetic mixture with air or with Oxygen or Nitrous Oxide.

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Symbols on VSP System
Label
Description
Warning
Precaution
Notes; indicates important general information for using
the system successfully.
Refer to instruction manual/ booklet
NOTE: On ME EQUIPMENT "Follow instructions for
use.”
XXXX
Manufacturer and date of manufacture
WEEE Directive for disposal of Electrical and Electronic
Equipment

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Table of Contents
1Glossary...................................................................................7
2VSP System Introduction......................................................8
2.1 GENERAL DESCRIPTION...................................................8
2.2 PHYSICAL DESCRIPTION ..................................................9
2.3 VSP GATEWAY PLACEMENT ..........................................10
1VSP Gateway Basic Operation .......................................... 11
1.1 FOR YOUR GENERAL SAFETY ........................................11
3Getting Started..................................................................... 12
3.1 INSTALLING THE SIM CARD/MICRO SD CARD ................... 12
3.2 CHARGING THE BATTERY...............................................13
3.2.1 How much charge is in the battery? ................... 13
3.2.2 Switching Your Device On/Off............................ 14
3.3 SETTING UP YOUR DEVICE FOR THE FIRST
TIME WILL BE DONE BY LIFEWATCH TECHNICAL STAFF...............14
3.3.1 Waking Up Your Device .....................................14
3.4 GETTING AROUND YOUR DEVICE ...................................14
3.4.1 Touch Control.....................................................14
4Using the Gateway Application......................................... 15
4.1 STARTING THE APPLICATION ..........................................15
4.2 VSP SCREEN ............................................................... 15
4.3 GATEWAY APPLICATION FUNCTIONS...............................15
4.4 DISPLAYING THE MEDICAL SIGNALS................................15
4.4.1 Displaying HW/SW Version on the About Screen17
4.4.2 Displaying Alerts................................................. 17
5Cleaning and Maintenance................................................. 18

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5.1 CONDITIONS OF USE .....................................................18
5.2 CARING FOR YOUR VSP GATEWAY................................. 18
5.3 CLEANING .................................................................... 19
5.4 ENVIRONMENT..............................................................19
2Troubleshooting .................................................................. 20
3Specifications....................................................................... 21
Appendix A Warnings and Precautions................................... 23
NOTICE POLICY AND MEDICAL WASTE DISCLAIMER........

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1 GLOSSARY
VSP TRANSMITTER
Main Processing Unit, vital sign data
communication device that collects the body vital
signs and sends these signs to the gateway
device.
ECG
Electrocardiogram; a representation of the
heart's electrical activity recorded from
electrodes on the body surface
VSP Gateway
Device for receiving vital signs from the VSP
TRANSMITTER and transmitting them on to the
monitoring center.
Heart Rate
The number of heartbeats per unit of time,
usually per minute.
Monitoring
Center
Monitoring Center equipped with hardware and
software that receives, analyzes and stores vital
signs signals received from the VSP system, and
can generate reports for the medical staff
Respiration Rate
The number of movements of the chest wall per
unit of time, indicative of inhalation and
exhalation
RF
A range of radio frequencies used for wireless
transmission
Saturation
Blood’s oxygen saturation level measured in
percentage
Temperature
The patient’s body temperature recorded from a
thermistor on the body surface
VSP
Vital Signs Patch device (patch with transmitter
and cradle)

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2 VSP SYSTEM INTRODUCTION
2.1 General Description
The VSP system is a medical device that records heart rate, ECG (3
Lead), surface temperature, blood oxygen saturation and
respiration; the VSP transmits the vital sign recordings to a
Monitoring station for viewing by medical personnel.
Figure 1 - Vital Sign Patch System

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2.2 Physical Description
Front View
Rear View
Loudspeaker Rear Camera
Rear Cover Removed
Reset Button
Micro SD Card Slot
SIM card Slot
Home Key
Back Key
Menu Key
Speaker
USB connector
Volume +/–
Earphone plug
Power on/off
Front camera
Microphone

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2.3 VSP Gateway Placement
For optimal system performance, the recommended distances
between the VSP Gateway and VSP Patch should be as follows:
–Within 20 inches (50 cm) for normal operation
–Within 10 feet (3 meters) during VSP Gateway charging
–Within 30 feet (10 meters) maximum distance

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1 VSP GATEWAY BASIC OPERATION
1.1 For Your General Safety
The VSP Gateway device is a cell phone used within a medical
system.
Do not make or receive handheld calls while driving;
do not text while driving.
Keep the device away from pacemakers, ICDs
and other electronic medical devices (at least 6
inches/15 cm).
Do not use the device at gas/petrol stations.
Do not expose the device to extreme
temperatures.
Keep your phone at least 15 mm away from your
ear or body while making calls.
Switch the device off when asked to in hospitals
and medical facilities.
Your phone may produce a bright or flashing light.
Avoid contact with liquids. Keep your phone dry.
Small parts may cause choking.
Switch the device off when told to in aircrafts and
airports.
Don’t dispose of your device in fire.
Don’t take your device apart.
Your device can produce a loud sound.
Switch your device off when near explosive
materials or liquids.
Avoid contact with anything magnetic.
Only use approved accessories.
Do not rely on your device for emergency
communications.
Before using the VSP Gateway please read Appendix A,
Warnings and Precautions, thoroughly.

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3 GETTING STARTED
3.1 Installing the SIM card/micro SD card
1. Switch off your device before installing SIM.
2. Open the SIM card holder by sliding it in the direction of the OPEN
arrow.
3. Hold the SIM card by the cut corner and slip it into the card holder.
4. Pull the micro SD cover tag by sliding it in the direction of the OPEN
arrow.
5. Hold your micro SD card with the metal contacts facing down and
slide it in.
6. Press the micro SD cover gently back into place, sliding it in the
direction of the LOCK arrow
7. Press the SIM card holder gently back into place, sliding it in the
direction of the LOCK arrow, until you hear a click.
SIM card SD card
Rear cover removal –Place your fingernail in the notch in the bottom
of the device and pull the rear cover upwards.
Note: Do not bend or twist the back cover excessively; doing so may
damage the cover.
NOTE: micro SD logo is a trademark of the SD Card
Association.
fff
Open
Lock
SIM card
Micro SD card cover
Lock
Open

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3.2 Charging the Battery
1. Connect the supplied USB plug to the USB/adapter jack. Ensure that
you insert the plug with the correct orientation. Do not force the plug
into the jack.
USB input is 5 VDC: maximum 5.25VDC to minimum 4.75VDC at
1A max.
2. Connect the USB cable’s USB plug to the adapter.
3. Connect the adapter to a standard AC wall outlet.
4. Disconnect the adapter when the battery is fully charged.
NOTE: When you first receive your device you will need to charge the
battery for 12 hours with the device turned off.
Use only the supplied adaptor PA1005-050UIB070.
Input is 100 to 240 V, ~50 to 60 Hz, 0.3A;
Output is 5 V, 0.7A, 3.5 W maximum
3.2.1 How much charge is in the battery?
If the battery is low, a message appears. When charging, there will be an
indication of the battery level.
The VSP Gateway battery level icon ( ) indicates when charging is
needed. When charging is complete, the battery level icon will indicate full
charging ( ).
Battery full
Battery
partially drained
Battery very
low
Battery
charging
When finished, disconnect the VSP Gateway charger from the power
adapter and then from the VSP Gateway.

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3.2.2 Switching Your Device On/Off
Hold Power to switch on your device.
To switch it off, hold Power to get the device options. Select Power
off, and then tap OK.
Always place the adapter in easily accessible main plugs.
In case of electrical malfunction of the device during the
connection to the adapter, remove the adapter from main plug
immediately.
3.3 Setting up Your Device for the First Time will be
done by LifeWatch Technical staff
3.3.1 Waking Up Your Device
1. Press Power to activate your screen display.
2. Drag the icon to the right.
3.4 Getting Around Your Device
3.4.1 Touch Control
You can use finger gestures to control your device. The controls on your
touchscreen change dynamically depending on the tasks you’re
performing.
1. Tap the buttons, icons, or applications to select items or to open
applications.
2. Keep your finger on an item to see the available options.
3. Flick the screen to scroll up, down, left or right.
4. Point, drag and drop to move particular items across the screen.
5. Pinch with two fingers or double-tap the screen to zoom in/out on a
web page or an image.
6. NOTE: You can view the device screen in portrait or landscape
orientation simply by holding it upright or turning it on its side. Not
all screens are viewable in landscape.

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4 USING THE GATEWAY APPLICATION
4.1 Starting the Application
To start the Gateway application
Activate the device running the application. The application is
automatically launched and the Main Screen is displayed.
The maximum unblocked distance between the VSP Transmitter and
the Gateway is 10 meters (30 ft.); walls and other obstructions will
reduce this distance. Do not exceed this distance under any
circumstances as this will prevent data transfer from the VSP
Transmitter. Do not place the Gateway under a metal frame bed.
4.2 VSP Screen
The VSP screen displays signal, connectivity, time, available battery power
and the Gateway application functions and screens.
4.3 Gateway Application Functions
The Gateway applicationdisplays the following information:
Full screen displaying medical signals (ECG or respiration)
Display of the HW/SW version on the About screen
Display Main screen with alerts
4.4 Displaying the Medical Signals
To display medical signals
Activate the device that contains the application. The main screen is
displayed.

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Figure 2 –Medical signal display
To choose display of ECG or respiration
1. Select the vital sign signal viewer from the display.
2. The raw signal data is displayed.
Figure 3 –ECG Respiration

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4.4.1 Displaying HW/SW Version on the About Screen
To display hardware/software information on the
screen
On the left bottom, press the Menu button. Then,
click Info. The Info screen is displayed with the
hardware, software and Gateway application
versions.
4.4.2 Displaying Alerts
An error initiates one of two types of alerts –one for the VSP Transmitter and
one for the Gateway.
4.4.2.1 VSP Transmitter Error Alerts
VSP system initiates 1-3 beeps (1 sec beep)
Gateway screen displays the error
4.4.2.2 Gateway Error Alerts
A Gateway error triggers the following alerts:
VSP Transmitter initiates sporadic beeping
Gateway screen displays the error
An alert will continue as long as the error
exists. Any errors occurring during an initial
alert will be indicated as well.
Once an error has been corrected, the
alert stops and the Main Screen is
displayed.

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5 CLEANING AND MAINTENANCE
5.1 Conditions of Use
The VSP Gateway conforms to internationalregulations insofar as it is used
under normal conditions and in accordance with theinstructions below.
5.2 Caring for your VSP Gateway
Do not open or attempt to repair your VSP Gateway yourself. Only
authorized service personnel may repair the product.
Do not bend the VSP Transmitter as this can damage the circuitry.
Do not use extreme force when pressing the button on the VSP
Transmitter.
Do not submerge the VSP Transmitter in water.

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5.3 Cleaning
A trained and certified technician is responsible for maintaining and cleaning
the reusable parts of the VSP System. The VSPGateway should be cleaned
prior to transferring to another patient.
5.4 Environment
Keep the VSP Gateway away from extreme heat. Do not leave it
on the dashboard of a car or near a heater. Do not leave it in any
place that is extremely damp or dusty.
Do not store the VSP Gateway in a place where it will be
continuously exposed to moisture or steam. Extended exposure to
moisture may cause malfunction.
The battery and electronics of the VSP Gateway are covered
by the European Directive 2012/19/EC (WEEE) or by other
local/national environmental regulations.
All electrical and electronic products should be disposed of
separately from the municipal waste stream via designated
collection facilities appointed by the government or the local
authorities.

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2 TROUBLESHOOTING
Problem
Possible
Cause(s)
Solution
VSP system
displays failure or
an inaccurate
reading.
Patch is loose or
detached.
Electrodes not
clean; skin is oily or
with excessive hair.
Make sure Patch is
correctly placed or detach
and reattach.
Restart Gateway.
Clean electrodes, clean or
shave skin.
Contact LifeWatch
customer service.
Data not
transmitted to
the Gateway.
Disconnected RF
channel between
VSP Transmitter
and Gateway.
1) Verify the Gateway is
set for communication and
the VSP system is listed
as a paired device.
2) Move the VSP
Transmitter closer to the
Gateway (Gateway has a
range of 10 meters).
3) Replace Patch.
4) Contact LifeWatch
customer service.
No display when
Gateway is
activated.
The battery is very
low or depleted.
Connect the Gateway to
charger to charge the
battery.
Hardware error.
Hardware not
functional.
Contact LifeWatch
customer service.
If you are experiencing a critical error not included in this table, restart any
running applications and then disconnect and reconnect the VSP
Transmitter. If the critical error is not resolved, contact LifeWatch
Customer Service.