LifeWatch VSPS 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:

1

Copyright Declaration

LifeWatch Technologies Ltd.® All rights reserved.

LifeWatch Technologies Ltd., LifeWatch Technologies Ltd. logo,

Vital Signs Patch System

are trademarks or registered trademarks

All other brand names and product names used in this document are trade

names, service marks, trademarks, or registered trademarks of their

The information and screens provided in this manual are subject to

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

LifeWatch Technologies Ltd.

7670202

Tel: [phone]
Fax: [phone]
Email: [e-mail]

please read

Copyright © 2013

LifeWatch Inc., LifeWatch Inc. logo,

and VSP

of LifeWatch Technologies Ltd.®.

respective owners.

change without notice.

Li

MATERIAL.

Authorized representatives:

Europe

Obelis s.a
Boulevard Général
Wahis 53
1030 Brussels,
BELGIUM
Tel: + (32) 2. 732.59.54
Fax: + (32) 2.732.60.03
E-mail: [e-mail]

Before using the VSP System
and Precautions in Appendix A and the
Contraindications on pages 5 and 6.

USA

LifeWatch, Inc.
O’Hare International Center
10255 West Higgins Road
Suite 120
Rosemont, IL 60018
Tel: [phone]
Fax: [phone]
Toll Free: 800-633-3361
Fax: [phone]
Email:
[e-mail]

2

Israel

2 Pekeris St.
Rehovot
Israel

the Warnings

Declaration of Conformity

disposable patch, a reusable

processing unit and a Smartphone based application.

internally powered equipment with

equipment

dust and splashing water.

Class IIa

Body Temperature)

:2005

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

(QS)

9001:2008, ISO 13485:2003

Requirements

Equipment not suitable for use in the presence of
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

The VSP System consists of a

 The VSP System is classified as

type BF applied parts.

 The device is suitable for continuous operation.

 The Patch (CG-1101XX) is classified as type IP54

affords protection against

 The VSP System is classified by the MDD as a

(Pulse oximeter; ECG; Heart Rate;

The VSP System is compliant with IEC 60601-1
IEC 60601-1-2:2007;

and

which

device

interference.

LifeWatch Technologies’ Quality System

certified to ISO-

CE 93/42 MDD and Canadian QS

is

WARNING
No modification of this equipment is allowed
Refer servicing to qualified personnel only.

DANGER

or order the use of the device.

3

flammable

Graphic Symbols on VSP System

indicates important general information for

Refer to instruction manual/ booklet

NOTE: On ME EQUIPMENT "Follow instructions

anufacture

for storage of the

WEEE Directive for disposal of Electrical and

heart rate,

vital signs or accelerometer

nor take any actions of a medical nature based on your

understanding UNLESS you are a medical professional.

Label Description

Warning

Precaution

Notes;
using the system successfully.

for use.”

Manufacturer and date of m

XXXX

Type BF Applied Part

Indicates the temperature limits
device.

Electronic Equipment

Symbol for no SPO2 alarms

Warning

Under no circumstances should you interpret your
temperature, saturation or respiration
data

body

4

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
monitoring
using the

should not

standard

12-lead vital signs via standard

be compared with readings obtained

non-standard

3-lead vital sign

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.)

5

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

6

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.

7

Table of Contents

1 Glossary ................................................................................ 10

2 VSP System Introduction ................................................... 11

2.1 G

2.2 T

ENERAL DESCRIPTION

HE

VSP KIT ................................................................ 12

................................................. 11

3 Physical Features ................................................................ 13

3.1 P

3.2 P

ARTS

......................................................................... 13

ATCH

......................................................................... 13

3.3 BRAIN ........................................................................ 14

3.4 G

3.5 G

ATEWAY APPLICATION

ATEWAY RECHARGING PROCEDURE

................................................. 15

............................. 17

4 Using the VSP System ........................................................ 18

4.1 G

4.2 P

ENERAL

ATCH

..................................................................... 18

......................................................................... 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 I

4.4 R

NSTALLING THE BRAIN

EMOVING THE

VSP ..................................................... 22

.................................................. 21

5 Using the Gateway Application ......................................... 23

5.1 S

5.2 VSP S

5.3 G

TARTING THE APPLICATION

CREEN

ATEWAY APPLICATION FUNCTIONS

............................................................... 23

.......................................... 23

............................... 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

8

5.3.4 Displaying Alerts ................................................. 25

5.3.5 Creating Manual Events ..................................... 26

6 Heart Rate Calculation Method .......................................... 28

6.1 I

6.2 M

NTRODUCTION

ETHOD OF CALCULATION

.............................................................. 28

............................................. 28

7 Maintenance ......................................................................... 29

7.1 C

7.2 C

7.3 C

7.4 E

ONDITIONS OF USE

ARING FOR YOUR

LEANING

NVIRONMENT

.................................................................... 30

.............................................................. 30

..................................................... 29

VSP ................................................ 29

8 Troubleshooting .................................................................. 31

9 Specifications ....................................................................... 32

9.1 VSP B

9.2 VSP P

RAIN SPECIFICATIONS

ATCH SPECIFICATIONS

......................................... 32

......................................... 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

9

1 GLOSSARY

BRAIN

ECG

Gateway device

VSP System User Guide

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

Monitoring

Center

Respiration Rate

RF

Saturation

Temperature

VSP

CG-1101XX

The number of heartbeats per unit of time,
usually per minute.

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

The number of movements of the chest wall per
unit of time, indicative of inhalation and
exhalation

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

2.2 The VSP Kit

VSP System User Guide

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

 Respiration sensor

Sensors

Figure 3 - Patch Components (general)

13

Cradle

BRAIN

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