LifeWatch VSPS Vital Signs Patch User Manual

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Date Submitted	2013-07-10 00:00:00
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Document Lastmod	2013-07-04 16:10:18
Document Title	User Manual

Dear LifeWatch Technologies Ltd. device owner:
Thank you for selecting the LifeWatch Technologies Ltd. Vital Signs Patch
(VSP) device, CG-1101XX (models CG-1101U, CG-1101B, CG-1101UC).
Please read this user guide before you start using your new device.
The guide contains important information about your device as well as
clear instructions about how to use it.
If you have any questions about the new Vital Signs Patch, please
contact:
Customer Service at:
Copyright Declaration
Copyright © 2013 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
feWatch 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.
Authorized representatives:
Europe
USA
Obelis s.a
Boulevard Général
Wahis 53
1030 Brussels,
BELGIUM
Tel: + (32) 2. 732.59.54
Fax: + (32) 2.732.60.03
E-mail: mail@obelis.net
LifeWatch, Inc.
O’Hare International Center
10255 West Higgins Road
Suite 120
Rosemont, IL 60018
Tel:
847-720-2295
Fax: 847-720-1995
Toll Free: 800-633-3361
Fax:
800-954-2375
Email:
webmaster@lifewatch.com
Israel
LifeWatch Technologies Ltd.
2 Pekeris St.
Rehovot 7670202
Israel
Tel: 972 8 9484000
Fax: 972 8 9484044
Email: users@lifewatch.com
Before using the VSP System please read the Warnings
and Precautions in Appendix A and the
Contraindications on pages 5 and 6.
Declaration of Conformity
The VSP System consists of a disposable patch, a reusable
processing unit and a Smartphone based application.

The VSP System is classified as internally powered equipment with
type BF applied parts.

The device is suitable for continuous operation.

The Patch (CG-1101XX) is classified as type IP54 equipment which
affords protection against dust and splashing water.

The VSP System is classified by the MDD as a Class IIa device
(Pulse oximeter; ECG; Heart Rate; Body Temperature)
The VSP System is compliant with IEC 60601-1:2005
:2005 and
IEC 60601-1-2:2007; however this does not preclude the possibility
of electronic interference from other equipment where the device will
need to be activated at a distance from the source(s) of
interference.
LifeWatch Technologies’ Quality System (QS) is
certified to ISO-9001:2008,
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.
DANGER
Equipment not suitable for use in the presence of flammable
anesthetic mixture with air or with Oxygen or Nitrous Oxide.
Federal Law (USA) restricts this device to sale by
or on the order of a practitioner licensed by the
law of the State in which he/she practices to use
or order the use of the device.
Graphic 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.”
Manufacturer and date of manufacture
anufacture
XXXX
Type BF Applied Part
Indicates the temperature limits for storage of the
device.
WEEE Directive for disposal of Electrical and
Electronic Equipment
Symbol for no SPO2 alarms
Warning
Under no circumstances should you interpret your heart rate, body
temperature, saturation or respiration vital signs or accelerometer
data nor take any actions of a medical nature based on your
understanding UNLESS you are a medical professional.
Intended Use
The Vital Signs Patch system is intended to be used by patients for
the continuous, non-invasive monitoring of ECG, Heart Rate (HR),
respiration, body temperature and blood saturation, when
prescribed by a physician or other qualified healthcare professional.
The VSP includes pacemaker detection to show pulses of
pacemaker on the screen and can therefore be used by users with a
pacemaker.
Readings obtained using the non-standard 3-lead vital sign
monitoring should not be compared with readings obtained
using the standard 12-lead vital signs via standard
electrode placement.
Contraindications
 The Vital Signs Patch (VSP) is not intended for use by
persons with any type of defibrillator, external or internal
(ICD); the VSP must be detached from the patient before
using a defibrillator on the patient.
 The VSP is not intended for the treatment or alleviation of
disease
 The VSP is not to be used in a magnetic resonance imaging
(MRI) environment; the VSP unit must be removed from the
patient’s skin before he/she undergoes MRI analysis.
 The VSP is not a “life-saving” or therapeutic device; the VSP
supplies vital signs data to a doctor or technician for the
purpose of diagnosis by such (or other qualified) personnel
 The VSP is not intended for use for patients who have
undergone surgery on the chest and who still have a fresh
incision on the chest
 The VSP is not intended for use on patients with any skin
damage on the area where the VSP is placed (such as burns,
irritation, infections, wounds, etc.)
Contraindications regarding ECG/Heart Rate
Due to the possible seriousness of the abnormal heart rhythms that
can be associated with the following conditions, persons with these
conditions should consult with their physician before using the VSP:

Coronary heart disease

Valvular heart disease

Heart transplant
Heart failure
General conditions for use of the VSP
Before using the VSP, check that you comply with the following
conditions:
You understand the principles of operation described in this
manual.
 You speak and understand English or have access to a fluent
English speaker who can explain how to use the device.
 You can attach the VSP to your body or have access to
someone who can attach the VSP to your body.
 You can operate the Gateway application software or have
access to someone who can operate the Gateway application
software.
 You can operate simple push-buttons.
Precautions:
 Use the device only for the purposes described in these
instructions for use.
 User Manual Warning: To prevent fire, do not expose the unit
unnecessarily to moisture, nor to or excessive heat.
Refer servicing to qualified personnel only
 Do not use this device if it is not working properly, or if it has
suffered any damage.

Table of Contents
Glossary ................................................................................ 10
VSP System Introduction ................................................... 11
2.1
GENERAL DESCRIPTION ................................................. 11
2.2
THE VSP KIT ................................................................ 12
Physical Features ................................................................ 13
3.1
PARTS ......................................................................... 13
3.2
PATCH ......................................................................... 13
3.3
BRAIN ........................................................................ 14
3.4
GATEWAY APPLICATION ................................................. 15
3.5
GATEWAY RECHARGING PROCEDURE ............................. 17
Using the VSP System ........................................................ 18
4.1
GENERAL ..................................................................... 18
4.2
PATCH ......................................................................... 18
4.2.1
Preparing the Skin .............................................. 18
4.2.2
Placing the Upper 3-lead Patch .......................... 19
4.2.3
Placing the Lower 3-lead Patch .......................... 20
4.3
INSTALLING THE BRAIN .................................................. 21
4.4
REMOVING THE VSP ..................................................... 22
Using the Gateway Application ......................................... 23
5.1
STARTING THE APPLICATION .......................................... 23
5.2
VSP SCREEN ............................................................... 23
5.3
GATEWAY APPLICATION FUNCTIONS ............................... 23
5.3.1
Displaying the Main Screen ................................ 24
5.3.2
Displaying Sensor Data ...................................... 24
5.3.3
Displaying HW/SW Version on the About Screen25
6
5.3.4
Displaying Alerts ................................................. 25
5.3.5
Creating Manual Events ..................................... 26
Heart Rate Calculation Method .......................................... 28
6.1
INTRODUCTION.............................................................. 28
6.2
METHOD OF CALCULATION ............................................. 28
Maintenance ......................................................................... 29
7.1
CONDITIONS OF USE ..................................................... 29
7.2
CARING FOR YOUR VSP ................................................ 29
7.3
CLEANING .................................................................... 30
7.4
ENVIRONMENT .............................................................. 30
Troubleshooting .................................................................. 31
Specifications....................................................................... 32
9.1
VSP BRAIN SPECIFICATIONS ......................................... 32
9.2
VSP PATCH SPECIFICATIONS......................................... 35
9.3
TRANSMISSION SPECIFICATIONS ..................................... 36
Appendix A Warnings and Precautions ................................... 37
END USER LICENSE AGREEMENT - SOFTWARE LICENSE
AGREEMENT ............................................................................... 47
NOTICE POLICY AND MEDICAL WASTE DISCLAIMER ........ 50
VSP System User Guide
1 GLOSSARY
BRAIN
ECG
Gateway device
Main Processing Unit, vital sign data
communication device that collects the body vital
signs and sends these signs to the gateway
device. The BRAIN can receive settings updates
from the Gateway
Electrocardiogram; a representation of the
heart's electrical activity recorded from
electrodes on the body surface
Device for receiving vital signs from the BRAIN
and transmitting them on to the monitoring
center; the gateway can receive settings updates
from 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
Saturation
Temperature
VSP
CG-1101XX
A range of radio frequencies used for wireless
transmission
Blood’s oxygen saturation level measured in
percentage
The patient’s body temperature recorded from a
thermistor on the body surface
Vital Signs Patch system
Internal Part Number indicating the type of Vital
Signs Patch (CG-1101C, CG-1101B
or CG-1101UC)
10
VSP System User Guide
2 VSP SYSTEM INTRODUCTION
2.1 General Description
The VSP system is a medical device that allows recording of heart
rate, ECG (up to 3 Lead), body temperature, oxygen blood
saturation and respiration; the VSP also enables transmission of
vital sign recordings to a Monitoring Center, thereby allowing your
physician or other medical personnel to monitor your health
condition anywhere, any time.
Figure 1 - Vital Sign Patch System
11
VSP System User Guide
2.2 The VSP Kit
1. 3-lead Disposable Patch for
upper placement
2. 3-lead Disposable Patch for
lower placement
3. Brain
4. Gateway device
5. Gateway Charger
6. Quick User Guide (not shown)
Figure 2 - VSP Kit Components
12
VSP System User Guide
3 PHYSICAL FEATURES
3.1 Parts
The VSP system includes the following components:
 Disposable Patch (CG-1101XX)
 Brain
 Gateway application
3.2 Patch
The Patch is a disposable unit that is attached to the body and contains
the following sensors:
 ECG sensor
 Temperature sensor
 Blood oxygen saturation sensor
Cradle
 Respiration sensor
BRAIN
Sensors
Figure 3 - Patch Components (general)
13
VSP System User Guide
3.3 BRAIN
The BRAIN is a non-disposable part, containing an RF transmitter and
a receiver for communicating with the Gateway. The BRAIN connects
to the Patch via a dedicated cradle located on the Patch.
The BRAIN includes a processor unit, and receives power and vital
signs data from the Patch. In addition, the Brain has an accelerometer
for sensing when a patient falls.
The BRAIN has a centrally placed event button for recording and
subsequent transmission of manual events. Events can also be
triggered manually via an icon on the Gateway application.
A LED rim around the button blinks to indicate the status of the VSP
system - a green light indicates that the VSP system is working
properly, while a red light indicates a problem (refer to the
troubleshooting section for details of possible problems).
Figure 4 - Brain Components
14
VSP System User Guide
3.4 Gateway Application
The Gateway application runs on a smartphone using the Android
operating system, RF capabilities (Nordic), and a proprietary
application.
Figure 5 - Gateway Application
15
VSP System User Guide
Gateway Placement
For optimal system performance, the recommended distances
between the Gateway and Patch should be as follows:
Within 20 inches (50 cm) for normal operation
– Within 10 feet (3 meters) during Gateway charging
– Within 30 feet (10 meters) maximum distance
–
16
VSP System User Guide
3.5 Gateway Recharging Procedure
Charge the Gateway whenever possible during the day. In addition,
charge the Gateway every night (regardless of battery level icon),
making sure that the VSP is within 10 feet (3 meters) of the Gateway.
The 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
To Charge the Gateway
1. Plug the Gateway charger power cord into the power socket on the
Gateway.
2. Plug the supplied Gateway charger unit into a standard wall outlet.
3. When finished, disconnect the Gateway charger from the wall outlet
and then from the Gateway.
17
VSP System User Guide
4 USING THE VSP SYSTEM
4.1 General
A certified clinician is responsible for dispensing the VSP to the patient.
A trained and certified technician is responsible for maintaining and
cleaning the reusable parts of the VSP System.
4.2 Patch
Before attaching the Patch you must prepare the skin.
4.2.1 Preparing the Skin
Skin Preparation
1. Wash the skin on the upper part of your chest using warm water
and gentle soap if the Patch is placed in the top location.
Figure 6 - Skin Hair-removal Region
2. Wash the skin on the lower part of your chest using warm water and
gentle soap, if the Patch is placed in the bottom location.
3. Remove excess hair from the areas by carefully clipping with
scissors. Avoid shaving in order to minimize irritation.
4. Make sure that your skin is clean and fully dry before proceeding.
5. Do not apply the patch to skin that is broken or irritated.
6. Contact LifeWatch if you have any questions concerning the use of
the device.
18
VSP System User Guide
Note
There are physiological conditions that may affect the
gateway from detecting the electrode connection for a
certain period of time. Even though the sensors
sensor seem to
be in good contact with the body, the alert message will
continue to appear. Some examples that can cause
delayed electrode recognition are very dry skin or contact
immediately after attaching the electrodes. If the
condition does not resolve, contact LifeWatch.
4.2.2 Placing the Upper 3-lead Patch
To place the patch
1. Peel off the plastic liner covering the adhesive from the back of the
Patch contact pad.
2. Dispose of the plastic liner.
3. Place the Patch on the skin vertically aligned with the mid-point of
the chest.
Figure 7 – Upper Patch Placement
19
VSP System User Guide
4.2.3 Placing the Lower 3-lead Patch
To place the patch
1. Peel off the plastic liner that covers the adhesive from the back of
the Patch contact pad.
2. Dispose of the plastic liner.
3. Place the Patch on the skin vertically aligned with the mid-point of
the left half of the chest, approximately 5 cm (2 inches) below the
left breast.
4. Place the upper electrode of the Patch approximately 5 cm
(2 inches) above the right of the sternum.
In order to collect vital sign data the Patch must be placed on an area
of the body containing veins. If the breast prevents the Patch from
being placed in the correct location, lift the breast slightly.
Figure 8 – Lower Patch Placement
20
VSP System User Guide
4.3 Installing the Brain
To install the Brain
1. Position the Brain in the cradle with the groove facing upwards and
the button facing outwards.
2. Push gently until the tab on the cradle locks into the groove on the
Brain. If the brain is correctly installed it will start to receive signals
from the sensors in the Patch (Brain/patch ON, removal of Brain
OFF).
Figure 9 - Placing Brain into Cradle
Ensure that the Brain is positioned properly with the correct side up
before pushing it into place.
Precaution: Using excessive force when putting the
Brain in the cradle can cause the pins to bend, preventing
the Brain from being installed or removed.
21
VSP System User Guide
4.4 Removing the VSP
To remove the patch
 Peel the Patch contact pads from the skin.
If you experience difficulty in removing the Patch contact pads, use
water to weaken the adhesive.
Do not use the VSP if you have a history of experiencing irritation to
electrode adhesives.
To remove the Brain
1. Lift the tab (Item 3 in Figure 9) holding the Brain in the cradle.
2. Place finger in the groove (Item 1 in Figure 9) on the top of the
Brain.
3. Gently pull the top of the Brain away from the cradle.
4. Remove the Brain from the cradle,, remove the battery from the
patch and place in the envelope to return to LifeWatch.
LifeWatch
WARNING
The Patch is for single use only.
Dispose of the Patch after use in a place designated as for
disposal of biomedical waste.
WARNING
Dispose of the battery in a battery disposal that meets WEEE
requirements.
Note
Returning the Patch to LifeWatch Services
ervices ensures proper disposal.
22
VSP System User Guide
5 USING THE GATEWAY APPLICATION
5.1 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 Brain 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 Brain.
5.2 VSP Screen
The VSP screen displays signal, connectivity, time, available battery power
and the Gateway application functions and screens.
5.3 Gateway Application Functions
The Gateway application has the following functions:
 Displaying the main screen
 Displaying sensor data
 Displaying HW/SW version on the About screen
 Displaying alerts
 Creating manual events
 Displaying questionnaires
23
VSP System User Guide
5.3.1 Displaying the Main Screen
To display the main screen
 Activate the device that contains the application. The main
screen is displayed.
Figure 10 – Main screen
5.3.2 Displaying Sensor Data
To display data on the signal viewer
1. Select one of the vital sign signal viewers from the Main Screen.
2. Enter the password. The raw signal data is displayed.
Figure 11 – ECG
Respiration
24
VSP System User Guide
5.3.3 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 About.
The About screen is displayed with the hardware, software and
Gateway application versions.
5.3.4 Displaying Alerts
An error initiates one of two types of alerts – one for the Brain and one
for the Gateway.
5.3.4.1 Brain Error Alerts
A Brain error triggers the following alerts:
 LED rim light flashes red
 VSP system initiates sporadic beeping (1 sec beep)
 Gateway screen displays the error
5.3.4.2 Gateway Error Alerts
A Gateway error triggers the following alerts:
 VSP brain 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.
25
VSP System User Guide
5.3.5 Creating Manual Events
There are two methods for creating a manual event:
 Pushing the Manual Event button on the Brain.
 Tapping the Manual Event button in the Gateway application.
When a manual event is created, the following occurs:
1. The Gateway application notifies the Monitoring Center that a
manual event was created.
2. A questionnaire appears in the Gateway application asking the
patient to identify the symptom(s) being experienced by the patient.
26
VSP System User Guide
Figure 12 - Gateway Questionnaire
5.3.5.1 Responding to the Gateway Questionnaire
To respond to the Gateway questionnaire
1. Tap to check the relevant symptom(s) from the predefined list.
2. Click Send. The questionnaire is closed, and the data is sent.
If the questionnaire is not completed in the allotted time, the responses
are sent to the Monitoring Center. If the patient does not respond to the
questionnaire after the allotted time, the blank questionnaire is sent to
the Monitoring Center.
27
VSP System User Guide
6 HEART RATE CALCULATION METHOD
6.1 Introduction
This section describes the heart rate (HR) calculation within the
LifeWatch V. HR is defined as the number of heart beats during a
GIVEN TIME INTERVAL (usually one minute). It is reported by the
algorithm each time a QRS complex is detected.
6.2 Method of Calculation
The momentary HR is the inverse of the time lasting between two
consecutive heart beats. As the momentary HR fluctuates due to
inaccuracies in detecting the exact R wave timing eight momentary
HR values are averaged to generate the displayed HR. Therefore
the reported HR is the mean of the last momentary HR values
WHICH CORRESPOND TO THE DETECTED R COMPLEXES
FOR THE LAST 8 SECONDS.
OCCASIONS IN WHICH THE HR IS NOT REPORTED: If during a
specific QRS complex the signal is considered as too low to be
considered accurate or is considered as noise, the displayed HR will
be 0.
7 PAUSE CALCULATION
Pause is considered a lack of Ventricular activity for more than 3
seconds. In order to detect a pause one of two conditions needs to
be detected:
1. Lack of QRS detection for more than 3 seconds
2. A flat signal (P complexes can occur) for slightly less than 3
seconds.
Once one of the above conditions is detected a pause event is
called.
28
VSP System User Guide
8 MAINTENANCE
8.1 Conditions of Use
Your VSP conforms to international regulations insofar as it is used
under normal conditions and in accordance with the instructions below.
8.2 Caring for your VSP
 Do not open or attempt to repair your VSP yourself. Only
authorized service personnel may repair the product.
 Do not bend the Brain, which can damage the circuitry.
 Do not use extreme force when pressing the button on the Brain.
 Do not submerge the Brain in water.
29
VSP System User Guide
8.3 Cleaning
The clinician should clean the Brain with a wet towel and 99% isopropyl
alcohol after use between patients.
8.4 Environment

Keep the VSP 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 in a place where it will be continuously
exposed to moisture, steam or perspiration, etc. Extended
exposure to moisture may cause malfunction.
The battery and electronics of the VSP 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.
You can also dispose of the Patch by returning it to
LifeWatch as per their instructions. Correct disposal of the
Patch will help prevent potential negative consequences
for the environment and human health.
30
VSP System User Guide
9 TROUBLESHOOTING
Problem
Possible
Cause(s)
Solution
VSP system
displays failure or
an inaccurate
reading.
Patch has become
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 is not
being
transmitted to
the smartphone.
Disconnected RF
channel between
Brain and
Gateway.
1) Verify the smartphone
is set for communication
and the VSP system is
listed as a paired device.
2) Move the Brain 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 Brain. If the critical error is not resolved, contact LifeWatch
Customer Service.
31
VSP System User Guide
10 SPECIFICATIONS
10.1 VSP Brain Specifications
Parameter
Min
Max
Typical
Input Operating DC
3.3
voltage
Average Current
10
consumption
Without SPO2
7.5
Peak Current
50
Consumption
Manual event
N/A
N/A
Yes
triggering
Environmental and Operating conditions
Operating temperature 10 (50)
45 (113) N/A
Environmental
10%
95%
Operation humidity
Environmental
70
106
atmospheric pressure
Transport & storage
-20 (-4)
65 (149) N/A
temperature
Transport & storage
10%
85%
humidity
Transport & storage
50
106
atmospheric pressure
Dimensions
Dimensions (max.)
N/A
N/A
59 x 47 x 9
(2.32 x
1.85 x
0.35)
Net Weight
23 (0.811)
32
Units
mA
mA
mA
None
°C (°F)
kPA
°C (°F)
kPA
mm
(inch)
gr. (oz.)
VSP System User Guide
Parameter
Min
ECG Input Impedance
ECG Input dynamic
range
ECG ADC sample
Rate
ECG DC offset
correction
ECG HPF Cutoff
Frequency
ECG System noise
10
N/A
+/- 5
N/A
MΩ
mV
250
250
250
Hz
+/-300
N/A
N/A
Respiration
Impedance
Respiration ∆
Impedance
Respiration Sampling
Rate
Temperature Range
Max
ECG
Units
mV
131
Hz
30
Respiration
500
2000
N/A
Mohm
0.2
N/A
Mohm
25
/sec
N/A
°C (°F)
0.3 (0.54)
°C (°F)
N/A
50
/sec
Temperature
35 (95)
42
(107.6)
Temperature Accuracy
Accelerometer
Acceleration Range
Accelerometer
Sampling Rate
Accelerometer
resolution
Typical
Accelerometer
0.1
6.0
μV
12bit A2D
33
VSP System User Guide
Parameter
Saturation LED
Current
Saturation
Measurement
Resolution
Saturation Noise (in
darkness)
Saturation Sampling
Rate
Min
Max
SPO2 specification
30
Typical
Units
mA
16bit A2D
2bit A2D
13
/msec
SPO2 parameters
Oxygen saturation
range:
Pulse rate range:
Data averaging and
update period
Measurement
wavelengths:
70 to 100 %
18 to 300 pulses per minute
3 seconds; data is sent every 0.5 seconds
Red 660 nanometers
Infrared 910 nanometers
The device does not have the capability to
Alarm indication
detect an SpO2 or pulse rate physiological
alarm condition
Pulse rate Accuracy
3 % ± 1 digits
SPO2 Accuracy
Root Mean Square (RMS) error: 3.5%
Note: because pulse oximeter equipment measurements are
statistically distributed, only about two-thirds of pulse oximeter
equipment measurements can be expected to fall within ±Arms of
the value measured by a co-oximeter.
34
VSP System User Guide
10.2 VSP Patch Specifications
VSP Patch specifications are listed below:
Parameter
Min
Dimensions (max.)
Upper N/A
Lower N/A
Max Typical
N/A
N/A
Battery type
Battery voltage
Battery capacity
Battery dimensions
Battery life
Net Weight
195 x 115
(7.7 x 4.5)
192 x 110
(7.6 x 4.3)
lithium/
manganese
dioxide
3.0
1500
5.5x35x35
Use
dependent
50 (1.76)
35
Units
mm (inches)
mm (inches)
mAh
mm
Days
(dependent
upon mode)
g (oz.)
VSP System User Guide
10.3 Transmission Specifications
Parameter
Operating Frequency
Typical
2.4GHz
Units
MHz
Output power
dBm
Crystal frequency
16
MHz
Frequency deviation @ 250kbps
±160
kHz
Frequency deviation @ 1Mbps
±160
kHz
Frequency deviation @ 2Mbps
±320
kHz
Air Data rate
kbps
Non-overlapping channel spacing
@ 250kbps/1Mbps
MHz
Non-overlapping channel spacing
@ 2Mbps
MHz
36
VSP System User Guide
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 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)
37
VSP System User Guide
Warnings
The VSP is not intended for use in the diagnosis of
myocardial infarction or for chest pain monitoring.
Due to the risk of ignition or fire, the VSP 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 or
accessories if you have a known allergy to nickel, silver or
other metals.
The VSP is not defibrillation-proof. Exposure to
defibrillation may damage the VSP, or the VSP may
interfere with the operation of the defibrillator.
The user of the VSP 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.
The VSP System should not be used to monitor chest pain
and it cannot predict or diagnose a heart attack
(myocardial infarction).
Do not operate the VSP 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.
38
VSP System User Guide
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 the device. 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.
If you are experiencing symptoms that are not consistent
with any of your monitoring, you should consult your
healthcare provider, doctor or other appropriate medical
professional.
39
VSP System User Guide
If you are taking medications you should consult your
healthcare professional concerning the possible effect of the
medications on the monitoring.
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.
40
VSP System User Guide
IMPORTANT FCC Part 15
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.
FCC WARNING
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 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 the receiver.
• Connect the equipment into an outlet 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.
41
VSP System User Guide
Gateway (Cellular Phone) 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.
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.
Hearing Aid Compatibility with Mobile Phones
FCC Hearing-Aid Compatibility (HAC) Regulations for Wireless
Devices
42
VSP System User Guide
On July 10, 2003, the U.S. Federal Communications Commission
(FCC) Report and Order in WT Docket 01-309 modified the
exception of wireless phones under the Hearing Aid Compatibility
Act of 1988 (HAC Act) to require digital wireless phones be
compatible with hearing-aids. The intent of the HAC Act is to ensure
reasonable access to telecommunications services for persons with
hearing disabilities.
While some wireless phones are used near some hearing devices
(hearing aids and cochlear implants), users may detect a buzzing,
humming, or whining noise. Some hearing devices are more
immune than others to this interference noise, and phones also vary
in the amount of interference they generate.
The wireless telephone industry has developed a rating system for
wireless phones, to assist hearing device users find phones that
may be compatible with their hearing devices. Not all phones have
been rated. Phones that are rated have the rating on their box or a
label located on the box.
The ratings are not guarantees. Results will vary depending on the
user’s hearing device and hearing loss. If your hearing device
happens to be vulnerable to interference, you may not be able to
use a rated phone successfully. Trying out the phone with your
hearing device is the best way to evaluate it for your personal
needs.
M-Ratings: Phones rated M3 or M4 meet FCC requirements and
are likely to generate less interference to hearing devices than
phones that are not labeled. M4 is the better/higher of the two
ratings.
T-Ratings: Phones rated T3 or T4 meet FCC requirements and are
likely to be more usable with a hearing aid’s telecoil than phones
that are not rated. T4 is the better/higher of the two ratings.
Hearing devices may also be rated. Your hearing device
manufacturer or hearing health professional may help you find this
rating. Higher ratings mean that the hearing device is relatively
43
VSP System User Guide
immune to interference noise. The hearing aid and wireless phone
rating values are then added together. A sum of 5 is considered
acceptable for normal use. A sum of 6 is considered for best use.
In the above example, if a hearing aid meets the M2 level rating and
the wireless phone meets the M3 level rating, the sum of the two
values equal M5. This should provide the hearing aid user with
“normal usage” while using their hearing aid with the particular
wireless phone. “Normal usage” in this context is defined as a signal
quality that is acceptable for normal operation.
The M mark is intended to be synonymous with the U mark. The T
mark is intended to be synonymous with the UT mark. The M and T
marks are recommended by the Alliance for Telecommunications
Industries Solutions (ATIS). The U and UT marks are referenced in
Section 20.19 of the FCC Rules. The HAC rating and measurement
procedure are described in the American National Standards
Institute (ANSI) C63.19 standard.
Some digital wireless phones may interfere with some hearing aids.
In the event of such interference, you may wish to consult your
hearing aid manufacturer to discuss alternatives.
44
VSP System 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
Brain 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 0.50 inch (1.5 cm) 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.
45
VSP System 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
the 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.
46
VSP System User Guide
END USER LICENSE AGREEMENT - SOFTWARE
LICENSE AGREEMENT
Single Use License
PLEASE READ CAREFULLY BEFORE USING THE DEVICE AND
SOFTWARE:
This License Agreement (“License”) for a certain LifeWatch Technologies Ltd.
(“Lifewatch”) product is a legal agreement between you (either an individual or
an entity) and Lifewatch, its affiliates, third party suppliers and licensors for all
the relevant software (which includes hardware and components provided by
suppliers and licensors to Lifewatch) bundled with the LifeWatch product
purchased by you, and as such may be updated from time to time (the
“Software”). BY ACTIVATING AND/OR USING THIS VITAL SIGNS PATCH
SYSTEM (HEREINAFTER, THE “DEVICE”) AND THE SOFTWARE, YOU
CONFIRM THAT YOU HAVE READ, UNDERSTOOD AND AGREE TO BE
BOUND BY THE TERMS OF THIS LICENSE AGREEMENT. If, prior to
indicating your acceptance by activating, using, downloading or installing this
Device and/or the Software, you decline, for any reason, any of the terms of this
License, you have no right to use the Device or the Software and you should: (i)
promptly return the Software to LifeWatch or, if downloaded by you, delete it; or
(ii) if you have purchased the Device on which the Software is pre-installed by
or on behalf of Lifewatch, promptly return the Device and the accompanying
Software and items (including Documentation and packaging) to LifeWatch or
the LifeWatch authorized distributor from whom you purchased the Device.
1. Grant of License. LifeWatch hereby grants to you a non-exclusive restricted
license to use the Software but only in conjunction with the Device in which the
Software is originally embedded and only in accordance with the accompanying
documentation (“Documentation”).
2. License Restrictions.
(a) Except to the extent otherwise expressly and unambiguously authorized by
LifeWatch or, with respect to any restriction which is explicitly prohibited by
applicable law, you shall NOT otherwise: (i) permit other individuals to use the
Software; (ii) modify, translate, reverse engineer, decompile, disassemble or
create derivative works based upon the Device, the Software or Documentation;
(iii) make any copies of the Software or Documentation; (iv) rent, lease, transfer,
sublicense or otherwise transfer rights to the Software or Documentation; (v)
remove any proprietary notices or labels on the Device, Software or
Documentation; or (vi) add, integrate or combine any other software with the
Software. ANY SUCH FORBIDDEN USE SHALL IMMEDIATELY TERMINATE
YOUR LICENSE TO THE SOFTWARE.
47
VSP System User Guide
(b) You agree that you shall only use the ce, Software and Documentation in a
manner that complies with all applicable laws in the jurisdictions in which you use
the Device, Software and Documentation, including, but not limited to, applicable
restrictions concerning relevant copyright and other intellectual property rights
and/or the export controlling regulations.
(c) You shall only use the Software and Documentation for your private, noncommercial use. You shall not use the Software in any way to provide, or as part
of, any commercial service or application. You shall not use the Device or the
Software in an attempt to, or in conjunction with, any device, program or service
designed to circumvent technological measures employed to control access to, or
the rights in, a content file or other work protected by the copyright laws of any
jurisdiction.
3. Title. Title, ownership, and intellectual property rights in and to the Software,
the Device, and Documentation shall remain vested in LifeWatch (including all its
relevant suppliers/licensors). The Software is protected by the copyright laws,
including those of the United States, the EU and international copyright treaties.
4. Transfer. You may not rent, lease, lend, sell, redistribute, or sublicense the
Software. You may, however, make a one-time permanent transfer of all of your
license rights to the Software to another party in connection with the transfer of
ownership of your Device, provided that: (a) the transfer must include your Device
and all of the Software, including all its component parts, original media, printed
materials and this License; (b) you do not retain any copies of the Software, full or
partial, including copies stored on a computer or other storage device; and (c) the
party receiving the Device and the Software reads and agrees to accept the terms
and conditions of this License.
5. Consent to Use of Data.
(a) LifeWatch is committed to keeping your personal information private, safe and
discrete. LifeWatch will never share, sell, rent, or trade any of your personally
identifiable information with third parties for their promotional commercial
purposes, without your consent.
(b) The developers of the Device and the Software have conscientiously and
carefully tried to present the Device and the Software in conformance with the
standards of professional practice and internationally accepted medical standards
that prevailed at the time of the manufacture of the Device and the publication of
the Software; however, such standards and practices in medicine may change as
new data become available and due to advances in technology, and you or any
medical professional with access to the Device or the Software should consult a
variety of professional sources as appropriate in the medical profession. In
addition, with respect to prescription medication, you are advised to check the
product information sheet accompanying each drug to verify conditions of use and
48
VSP System User Guide
identify any changes in dosage schedule or contraindications, particularly if the
agent to be administered is new, infrequently used, or has a narrow therapeutic
range. The Device and the Software are no substitute for individual patient
assessment based upon examination of each patient by a professional healthcare
provider and consideration of laboratory data and other factors unique to the
patient. The Device and the Software may be used as tools to help you
understand diagnostic and treatment decisions, bearing in mind that individual
and unique circumstance may lead you or your healthcare provider to reach
decisions not presented in the Software.
(c) Physicians and other healthcare professionals who use the Device and the
Software should exercise independent clinical judgment as to the information they
provide, and not rely on the Device, the Software or information derived therefrom
as a conclusive source for diagnosis or as a replacement for independent
examinations. Individuals with any type of medical condition are specifically
cautioned to seek professional medical advice before beginning any sort of health
treatment. For medical concerns, users should always consult their physician or
other qualified healthcare professional.
9. Disclaimer of Warranties.
(a) To the maximum extent permitted by applicable law, the Device, the Software
and any services are provided "as is" and "as available", with all faults and without
warranty of any kind, and LifeWatch hereby disclaim all warranties and conditions
with respect to the Device, the Software and services, either express, implied or
statutory, including, but not limited to, the implied warranties and/or conditions of
merchantability, satisfactory quality, fitness for a particular purpose, accuracy,
and non-infringement of third party rights.
10. Limitation of Liability. To the extent not prohibited by applicable law, in no
event shall LifeWatch be liable for personal injury, or any incidental, special,
indirect or consequential damages whatsoever, including, without limitation,
damages for loss of profits, corruption or loss of data, failure to transmit or receive
any data, business interruption or any other commercial damages or losses,
arising out of or related to your use or inability to use the Device, the Software
and services or any third party software or applications in conjunction with the
Device, the Software or services, however caused, regardless of the theory of
liability (contract, tort or otherwise) and even if LifeWatch has been advised of the
possibility of such damages. Some jurisdictions do not allow the limitation of
liability for personal injury, or of incidental or consequential damages, so this
limitation may not apply to you. In no event shall LifeWatch’s total liability to you
for all damages (other than as may be required by applicable law in cases
involving personal injury) exceed the amount actually paid by you for the Software
49
VSP System User Guide
and the Device. The foregoing limitations will apply even if the above stated
remedy fails to achieve its essential purpose.
11. Controlling Law and Severability. This License will be governed by and
construed in accordance with the laws of the state of New York, excluding its
conflict of law principles. This License shall not be governed by the United
Nations Convention on Contracts for the International Sale of Goods, the
application of which is expressly excluded. If for any reason a court of competent
jurisdiction finds any provision, or portion thereof, to be unenforceable, the
remainder of this License shall continue in full force and effect.
12. Complete Agreement; Governing Language. This License constitutes the
entire agreement between you and LifeWatch relating to the Device, the Software
and supersedes all prior or contemporaneous understandings regarding such
subject matter. No amendment to or modification of this License will be binding
unless in writing and signed by Lifewatch. Any translation of this License is done
for local requirements and in the event of a dispute between the English and any
non-English versions, the English version of this License shall govern, to the
extent not prohibited by local law in your jurisdiction.
13. Contacting Us. If you have any questions regarding this License or the use of
the Software or the Device, please contact us
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-00077 rev01
50
2013-03

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