LifeWatch Technologies LWVGW GSM/WCDMA Mobile Phone User Manual

LifeWatch Technologies Ltd. GSM/WCDMA Mobile Phone Users Manual

Contents

Users Manual

1
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:
2
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.
3
Declaration of Conformity
LifeWatch Technologies’ Quality System (QS) is certified
to ISO-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.
4
Symbols on VSP System
Label
XXXX
Manufacturer and date of manufacture
WEEE Directive for disposal of Electrical and Electronic
Equipment
5
Table of Contents
1 Glossary ................................................................................... 7
2 VSP System Introduction ...................................................... 8
2.1 GENERAL DESCRIPTION ................................................... 8
2.2 PHYSICAL DESCRIPTION .................................................. 9
2.3 VSP GATEWAY PLACEMENT .......................................... 10
1 VSP Gateway Basic Operation .......................................... 11
1.1 FOR YOUR GENERAL SAFETY ........................................ 11
3 Getting 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
4 Using 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
5 Cleaning and Maintenance ................................................. 18
31
6
5.1 CONDITIONS OF USE ..................................................... 18
5.2 CARING FOR YOUR VSP GATEWAY ................................. 18
5.3 CLEANING .................................................................... 19
5.4 ENVIRONMENT .............................................................. 19
2 Troubleshooting .................................................................. 20
3 Specifications ....................................................................... 21
Appendix A Warnings and Precautions ................................... 23
NOTICE POLICY AND MEDICAL WASTE DISCLAIMER ........
VSP Gateway User Guide
7
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 application displays 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 international regulations insofar as it is used
under normal conditions and in accordance with the instructions 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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19
5.3 Cleaning
A trained and certified technician is responsible for maintaining and cleaning
the reusable parts of the VSP System. The VSP Gateway 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.
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21
3 SPECIFICATIONS
Basic Parameters
LCD Parameter
4.3 inch 480*800 Pixels (WVGA)
Touch Lens
Yes (Capacitive Touch screen)
Processor
Dual-core, Cortex A9, 1GHz
Memory
4GB Flash + 1GB RAM
Android OS
Android 4.1.2, Jelly Bean
Storage Card
Micro-SD, up to 32GB
Battery Capacity
1480 mAh LI-IO, BAK512880P
Cellular Communication
WCDMA Bands
850/1900/2100MHz
HSPA Data rates
Down link 7.2 Mbps; Up link 5.76 Mbps
GSM Bands
850/900/1800/1900MHz
Short Range Communication
Wi-Fi(WLAN)
IEEE 802.11b/g/n
RF module (Nordic)
2.4 GHz
Bluetooth revision
Ver. 3.0
Main Camera
Pixel
8MP
Camera technology
CMOS
Auto Focus
Yes
Picture Size
Max 3264×2448
Zoom
Digital zoom 4X
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Front Camera
Pixel
0.3MP
Camera technology
CMOS
Picture Size
Max 640*480
Physical
Dimensions
(H*W*D)
132*71*13 mm
Weight
157 gram
Environmental
Operating
temperature
+10ºC to +40ºC
Note: Body temperature measurement
should be performed within an ambient
temperature range of 22-26°C
Humidity
10% to 95%, non-condensing
Atmospheric
pressure
70 kPa to 106 kPa
Transportation and
Storage Conditions
*Temperature range of -25ºC to +75 ºC
*Humidity range of 0 to 95%
*Atmospheric pressure range of 70 kPa to
106 kPa
VSP Gateway User Guide
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APPENDIX A WARNINGS AND PRECAUTIONS
Declaration of RoHS Compliance
The VSP was designed by LifeWatch Technologies Ltd. to comply
with Directive 2011/65 /EC of the European Parliament - RoHS
(Restriction of Hazardous Substances) - with respect to the limited
use or non-use use of the following substances in the device:
Lead (Pb)
Mercury (Hg)
Cadmium (Cd)
Hexavalent Chromium (Cr (VI))
Polybrominated biphenyls (PBBs)
Polybrominated diphenyl ethers (PBDEs)
VSP Gateway User Guide
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Warnings
Due to the risk of ignition or fire, the VSP system is not
intended for use in a hyperbaric chamber, within an oxygen
tent or in the presence of flammable anesthetics / medical
gases.
To prevent an allergic reaction, do not use the VSP system
or accessories if you have a known allergy to nickel, silver
or other metals.
The VSP system is not defibrillation-proof. Exposure to
defibrillation (including ICDs) may damage the VSP.
The lay user of the VSP system should not take any
actions of a medical or clinical nature based on his/her
understanding or interpretation of monitoring without
consulting a healthcare professional.
Do not operate the VSP system in combination with the
following medical electronic devices as this may cause a
malfunction of this device:
Electronic life support systems such as an artificial
heart/lung.
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25
Precautions
The VSP System generates, uses, and can radiate radio
frequency energy and, if not used in accordance with the
instruction manual, may cause harmful interference to radio
communications.
The VSP System employs cellular technology. The location
of the VSP System and the associated environment,
including cellular phone coverage in the particular area, may
cause transmission interruption or delay.
Do not open or attempt to repair any part of the system.
Only authorized service personnel may repair the system
components.
To avoid damage to the system, the system and
accessories should be kept away from extreme heat,
including placement of the VSP on the dashboard of a car
or near a heater.
The system should not be subjected to severe impact or
bending force. Exposure to these types of stresses can
damage the system components.
Do not use or store the VSP in a location where liquids such
as water, juice, coffee can splash on it.
The VSP is intended to be used in conjunction with a
monitoring service that reviews the transmissions and
provides information to the physician for his/her final
diagnostic interpretation.
The VSP is not intended for use as an emergency medical
response system and should not be used by patients at risk
for serious or life-threatening cardiac arrhythmias.
VSP Gateway User Guide
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Note: Modifications not expressly approved by the manufacturer
could void the user authority to operate the equipment. THE
MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO
OR TV INTERFERENCE CAUSED BY UNAUTHORIZED
MODIFICATIONS TO THIS EQUIPMENT. SUCH
MODIFICATIONS COULD VOID THE USER'S AUTHORITY TO
OPERATE THE EQUIPMENT.
minimum of 1.0 cm from the body.
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Warning - Specific Absorption Rate (SAR) information
SAR tests are conducted using standard operating positions
accepted by the FCC with the phone transmitting at its highest
certified power level in all tested frequency bands, although the
SAR is determined at the highest certified power level, the actual
SAR level of the phone while operating can be well below the
maximum value, in general, the closer you are to a wireless base
station antenna, the lower the power output.
Before a new model phone is a available for sale to the public, it
must be tested and certified to the FCC that it does not exceed the
exposure limit established by the FCC, Tests for each phone are
performed in positions and locations (e.g. at the ear and worn on
the body)as required by the FCC.
For body worn operation, this model phone has been tested and
meets the FCC RF exposure guidelines when used with an
accessory designated for this product or when used with an
accessory that contains no metal and that positions the handset a
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. Any Changes or modifications not expressly
approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
Note: 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
VSP Gateway User Guide
28
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 turning
the equipment off and on, 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.
--Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
--Consult the dealer or an experienced radio/TV technician for help.
NOTE: THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY
RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED
MODIFICATIONS TO THIS EQUIPMENT. SUCH MODIFICATIONS
COULD VOID THE USER'S AUTHORITY TO OPERATE THE
EQUIPMENT.
Gateway (Model number FGL-00005, FCC ID:
SMTLWVGW) Warnings
Using Your Gateway near Other Electronic Devices
Most modern electronic equipment is shielded from radio frequency
(RF) signals.
However, certain electronic equipment may not be shielded against
the RF signals from your wireless phone. Consult the manufacturer
to discuss alternatives.
Implantable Medical Devices
A minimum separation of six (6) inches (15 cm) should be
maintained between a handheld wireless phone and an implantable
medical device, such as a pacemaker, to avoid potential
interference with the device.
VSP Gateway User Guide
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Persons who have such devices:
• Should ALWAYS keep the phone more than six (6) inches (15 cm)
from their implantable medical device when the phone is turned
ON;
• Should not carry the phone in a breast pocket;
• Should use the ear opposite the implantable medical device to
minimize the potential for interference;
• Should turn the phone OFF immediately if there is any reason to
suspect that interference is taking place.
• Should read and follow the directions from the manufacturer of
your implantable medical device. If you have any questions about
using your wireless phone with such a device, consult your health
care provider.
1.0 cm0.40 inch
30
VSP Gateway User Guide
Other Medical Devices
If you use any other personal medical device, consult the
manufacturer of your device to determine if it is adequately shielded
from external RF energy. Your physician may be able to assist you
in obtaining this information. Switch your phone off in health care
facilities when any regulations posted in these areas instruct you to
do so. Hospitals or health care facilities may be using equipment
that could be sensitive to external RF energy.
Children Using Wireless Phones
The scientific evidence does not show a danger to users of wireless
phones, including children and teenagers. If you want to take steps
to lower exposure to radio frequency energy (RF), the measures
described above would apply to children and teenagers using
wireless phones. Reducing the time of wireless phone use and
increasing the distance between the user and the RF source will
reduce RF exposure.
Some groups sponsored by other national governments have
advised that children be discouraged from using wireless phones at
all. For example, the government in the United Kingdom distributed
leaflets containing such a recommendation in December 2000. They
noted that no evidence exists that using a wireless phone causes
VSP Transmitter tumors or other ill effects. Their recommendation to
limit wireless phone use by children was strictly precautionary; it
was not based on scientific evidence that any health hazard exists.
Body-worn Operation
To comply with RF exposure requirements, a minimum separation
distance of ( ) must be maintained between the
user’s body and the handset, including the antenna. Third-party
belt-clips, holsters, and similar accessories used by this device
should not contain any metallic components. Body-worn
accessories that do not meet these requirements may not comply
with RF exposure requirements and should be avoided.
31
VSP Gateway User Guide
Use only the supplied or an approved antenna. Unauthorized
antennas, modifications, or attachments could impair call
quality, damage the phone, or result in violation of
regulations. Do not use a phone with a damaged antenna. If a
damaged antenna comes into contact with the skin, a minor burn
may result. Please contact your local dealer for replacement
antenna.
NOTICE POLICY AND MEDICAL WASTE DISCLAIMER
BY USING THE DEVICE, SOFTWARE, WEBSITE AND/OR WEBSITE
SERVICES YOU HEREBY AGREE TO BE BOUND BY THE FOLLOWING
NOTICE POLICY AND MEDICAL WASTE DISCLAIMER. IF YOU DO NOT
AGREE WITH THE NOTICE POLICY AND/OR MEDICAL WASTE DISCLAIMER,
YOU SHOULD DISCONTINUE USE OF THE DEVICE, SOFTWARE, AND/OR
OTHER SERVICES.
MEDICAL WASTE DISCLAIMER
In no event shall LifeWatch be liable for personal injury, or any incidental, special,
indirect or consequential damages whatsoever that result from the disposal of any
medical waste.
UG-00077GW rev01 2014-01

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