Cardiac designs Ecg check User manual

Cardiac Designs LLC

ECG-Check

User

User Manual

Manual

This document contains proprietary information of Document No. Rev. Page of

Cardiac Designs LLC ECGC-70-003 02

1 23

User Manual

ECG-Check - OTC

RESTRICTION ON USE, DUPLICATION, OR

DISCLOSURE OF PROPRIETARY INFORMATION

This document contains proprietary information,

which is the sole property of the company. The document is

submitted to the recipient for his use only. By receiving

this document the recipient undertakes not copy or

disclose part of, or the whole of the information contained

herein to any third party without receiving beforehand,

written permission from submitting company.

Name Title Signature Date

WRITTEN BY M. J ANDES TEAM LEADER ONFILE ONFILE

APPROVED BY K. M ARROUCHE MANAGING DIRECTOR ONFILE ONFILE

Cardiac Designs LLC

ECG-Check

User

User Manual

Manual

This document contains proprietary information of Document No. Rev. Page of

Cardiac Designs LLC ECGC-70-003 02 2 23

Version

Version Date

Date

Date Name

Name

Name Description

Description

01 1/16/2013 C. Pillar Initial Document

02 1/18/2013 M. Jandes Added screen shots of progress bar

ECG Check Wireless

1-Lead Cardiac Monitor

OTC Use

ii

Dear

Dear ECG

ECG

ECG Check

Check

Check Owner:

Owner:

Thank you for selecting the ECG Check cardiac monitor.

This user guide includes information and instructions about your new ECG Check

and will help familiarize you with the basic skills of using your ECG Check, so please

take a moment to read it carefully before you begin testing.

We have included a warranty registration card.

Please complete and return it promptly to enable us to provide you the full benefits

regarding your ECG Check product.

For the most up-to-date list of compatible devices, please refer to the supported list

at http://www.cardiacdesigns.com.

We care about what you think and want to keep you informed about its use and care.

If you have any questions about your new ECG Check, please contact:

Cardiac Designs, LLC

3293 Niblick Rd

Park City, UT 84098

Tel: 512-582-2453

Fax: 713.589.7964

Email: [email protected]

Website: www.cardiacdesigns.com

iii

Copyright

Copyright Declaration

Declaration

Copyright

©

2012 Cardiac Designs, LLC

iPhone, iPad, iPod, iOS and the Apple l o go are either registered trade m arks or

trademarks of Apple Corporation in the United Statesand/or other countries.

Cardiac Designs, LLC,Cardiac Designs logo, and ECG Checkand ECG Web Center are

trademarks orregistered trade m arks of Cardiac Designs, LLC.

All other br a n dnames and product na m es used i n this document are trade

na m es,ser v icemar k s,trade m arks, o rregistered trademarks of their re s pective

owners.

The information and screens provi d ed in this manual aresubjectto change without

notice.

Card iac Designs, LLC SHALL NOT BE LIABLE FOR TECHNIC A L OR EDI T ORIAL

E RRORS O R OMISSI O NS CON T AIN E D HEREIN; NOR F O R INCIDEN T AL OR

CONSEQUENTIAL DAMAGES RESU L T I N G F R OM THE FU R NI S HING,PE R FORMA NCE ,

OR USE OF THIS MAT E RIAL.

Authorized Representatives:

USA

Cardiac Designs, LLC

3293 Niblick Rd

Park City, UT 84098

512-582-2453

Declaration

Declaration of

of

of Conformity

Conformity

Conformance to St a ndards – non-c l inical testing de m onstrated conformance

tovoluntary safetyIEC60601-1 andtoIEC60601-1-2-2001 ClassB

Warning: Changes or modifications to this unit 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

iv

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 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.

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.

Cardiac Design, LLC ’ sQuality Systemconfo r m s to21 CFR 820 and ISO13485:2003

Danger

Equip m ent not suitable f o r use in the pre s en c e of fla mm a ble anesthetic m ixture w i th

a i r or with O x yg en or Nit r ous O x id e .

Graphic

Graphic Symbols

Symbols

Symbols on

on

on ECG

ECG

ECG Check

Check

Thi s s ym b o l

i

s i n ten d e d t o

aler

t th e u

se

r t o t h e pres e nc e o f

im portant opera

t

ing and m a i n tenan c e(ser v

i

c ing) i n s

t

ru c

t

ions

in the literatu

r

e a c co m panyin g th e appl

i

a nce.

This s ym b ol

i

n di c ates

t

y p eBF eq u i pm ent c

l

a s s

i

fi e d in

acc o rda n ce with IEC Pu b l i c at io n

601-

1

Safet

y o f medi c a l

ele c tr

i

cal eq u ipment.

v

Intended

Intended Use

Use

The ECG Check is intended for use whenever you are interested in your cardiac

activity. It can be used any time, including during or after strenuous activity (i.e.,

during or after exercise) or if you experience the following symptoms that are

suggestive of abnormal heart rhythms:

•Skipped Beats

•Pounding Heart (Palpitations) Heart Racing or Irregular Pulse

•Lightheadedness or Faintness

•History of Arrhythmias

The ECG Check is not intended for diagnostic use and does not provide diagnostic

quality ECG data.

Contraindications

There a

r

e no pote n

t

i a l a d ver s e ef

f

ec

t

s o f

th

e ECG Check o n

health.

vi

Who

Who Should

Should

Should NOT

NOT

NOT Use

Use

Use the

the

the ECG

ECG

ECG Check

Check

In order to use this device, you must be able to perform all of the following:

•Understand principle of operation described in this manual

•Speak and understand English

•Place the ECG Check in your hands or on your chest and hold it for at least 30

seconds

•Operate a ECG Check and the Web Center application

•Operate simple push-buttons

Due to the possible seriousness of the abnormal heart rhythms that can be

associated with these conditions, persons with the following conditions should

consult their physician before using this device:

•Coronary heart disease

•Valvular heart disease

•Heart transplant

•Heart failure

vii

Warning

The ECG Check is not a diagnostic device.

This non-standard 1 - lead electrocardiogram (ECG), which is measured using the

ECG Check, should not be used for diagnostics in comparison to the standard 12 lead

ECG obtained with standard electrode placement.

This device should not be used with pacemakers or implanted defibrillators and

cannot predict or diagnose a heart attack or be used for chest pain monitoring.

The ECG Check is not a defibrillation-proof device.

To pre v ent fire or s h ock h a zard,do not e x po s e the u n

i

t t o r a i n o r mo

i

sture.

Refer

servicing to qua l i

f

i e d pe

r

sonn e l onl y .

When used as an Over-the-Counter device, the display function for actual ECG

waveforms and ECG reports is disabled. To access the display feature for viewing

your ECG date, contact your physician and obtain a prescription. Only patients

under the care of a physician with a prescription for this service may view ECG data

and ECG reports.

viii

Table

Table of

of

of Contents

Contents

Dear

Dear ECG

ECG

ECG Check

Check

Check Owner:

Owner:

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

ii

Copyright

Copyright Declaration

Declaration

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

iii

Declaration

Declaration of

of

of Conformity

Conformity

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

iii

Danger

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

iii

Graphic

Graphic Symbols

Symbols

Symbols on

on

on ECG

ECG

ECG Check

Check

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

iv

Intended

Intended Use

Use

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

iv

Contraindications

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

iv

Who

Who Should

Should

Should NOT

NOT

NOT Use

Use

Use the

the

the ECG

ECG

ECG Check

Check

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

v

Warning

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

vi

Quick

Quick Start

Start

Start Guide

Guide

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

1

ECG

ECG Check

Check

Check Introduction

Introduction

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

4

General Description

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

4

The ECG Check Kit

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

4

Using

Using the

the

the ECG

ECG

ECG Check

Check

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

5

General

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

5

Before Testing

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

6

Recording

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

6

Medical Records

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

8

Maintenance

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

9

Battery Replacement

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

9

Conditions of Use

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

9

Caring for your ECG Check

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

9

Environment

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

9

Precautions

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

10

Preventive Maintenance

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

10

Mechanical Inspection

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

10

Cleaning

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

10

Troubleshooting

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

11

Glossary

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

12

Technical

Technical Specifications

Specifications

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

13

Additional

Additional Information

Information

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

14

Quick

Quick Start

Start

Start Guide

Guide

1. Install the ECG Check Application on the iPhone via the iPhone App Store or

visit http://ecgcheck.com from your iPhone for a direct link (first time use).

2. Ensure data and Bluetooth communications are enabled.

a. Configure the outgoing communication to the ECG Check Web Center

by enabling either cellular data or Wifi (or both -- See your iPhone

documentation for more information).

b. Configure the ECG communication to the ECG Check device by

ensuring your Bluetooth radio is enabled.

2

3. Start the ECG Check Application on the iPhone by pressing the ECG Check

icon.

4. Set up the user profile (first time use or when necessary).

5. Place your fingers on the silver pads of the ECG Check device to start the ECG

recording.

6. Once the progress bar is full, the recording will be automatically stored and

sent for analysis. Upon completion, you will see the screen below.

3

ECG

ECG Check

Check

Check Introduction

Introduction

General

General Description

Description

The ECG Check is a medical d e v i ce that allo w s recording and sending of an E C G

re c ording (u s i ng Bl u etooth tech n ology).The recording is s e nt to a dev i ce (ECG Check

Application compatible iPhone). This allows y o u and your physicia n t o m onito r you r

health information (ECG) from anywhere any time you wish.

The

The ECG

ECG

ECG Check

Check

Check Kit

Kit

1. ECG Check Monitor

2. (1) CR2032 Battery

3. Quick User Guide (this document)

4

Using

Using the

the

the ECG

ECG

ECG Check

Check

General

The ECG-Check is a single lead ECG recording device that uses the 2 built-in

electrodes (silver pads) on the underside of the device to record and transmit your

ECG to an application via Bluetooth for display and analysis.

Place your fingers on the electrodes or place the device on your chest to start the

recording.

Device Functions

1. On/Record

•If the device is off, pressing your fingers to the electrodes will turn the device

on and begin recording once the device has initiated communication with the

iOS application.

5

•If the iOS application is not loaded, please start the iOS application prior to

initiating a recording on the device. The device will not begin recording data

until the iOS application has been started.

2. Standby / Power Off

•The device will turn off automatically after the device has detected no skin

contact for 4 seconds. If there was an on-going test, the test will be

invalidated and need to be restarted

Note: T he de v i c e s t a r t s

re co rd i ng

wh en there

i s e le c tro d e c ont a ct w ith

t he

s k

in

AND the iOS has communicated with the device via Bluetooth to begin

recording

Before

Before Testing

Testing

Read the testing ins t ructions before atte m pt i ng a test.Pay careful attention to the

e l e c trode po s i t

i

on s a s

i

n st

r

ucte d .

Mak e s u r e y ou h a v e a ll i

t

e m s needed to test:

•ECG Check

•ECG Check Appli c ation comp a tible iPhone(with application installed)

Recording

1. Verify that Bluetooth is on and cellular data is enabled on the iPhone.

6

2. Start the ECG Check application by tapping the ECG Check icon.

3. Log into your user account.

4. Press your fingers to the electrodes to initiate a recording.

5. Wait for the progress bar to fill up while the system records your ECG.You

will see the screen shown below as it is recording.

6. The system will automatically send the ECG for analysis.

Medical

Medical Records

Records

To examine a list of previous recordings stored on the device, tap the medical

history icon to open the medical history screen; here you will see a list of the

previous tests stored on your device.

7

8

Maintenance

Battery

Battery Replacement

Replacement

Caution: Use only CR2032 lithium ion batteries.

1. Place the ECG Check device with electrode pads down on a stable surface

2. Using a Phillips head screwdriver, unscrew the screw securing the battery

cover.

3. Slide out the used battery

4. Slide in the new CR2032 lithium ion battery

5. Replace the battery cover and secure with the cover screw

Conditions

Conditions of

of

of Use

Use

You r ECG Check

conform

s

t

o i

nternat

i o n a l r e gula

t

io n s in s o far a s

i

t

i

s u sed under

nor ma l cond

i

t

ions a nd in a c cor d ance w

i

th t h e fo

l

l ow

i

n g

in

str u cti o ns.

Caring

Caring for

for

for your

your

your ECG

ECG

ECG Check

Check

D o no t o pe n o r att e mp t t o

repai

r y o u r

ECG

Check

yourself

. Only authori z ed ser v ice

personnel may repa i r the product.

D o no t d

r

o p you r ECG Check o r s u bj

e

c t i t t o s e v e r e im

pa

c

ts

.Be n d

i

n g

the

bod y ca n

damag e th e

ci r

cui

t

ry . D o no t u s e extre m e force when pres s ing the dis p l a y o r k e

ys.

Do not u s e sol v ents to clean y o ur ECG Check. Us e o n l y a s o ft , d

r

y cl o

th.

Environment

Keep a w a y f

r

om e x tr e m e heat.Do not l e a v e

i

t on t h e da s hboa

r

d of a car o r nea r a

heater

. D o no t

lea

v e

i

t

i

n an y p

l

ace

t

h at is e x trem e l y damp or d u sty.

9

As t h is p r od u ct

i

s n ot wat e rp

roof

, d o no t u s e i t o r s to r e i t wher e

flu

i d s

suc

h

as

wate r

ca n

spla

s h

ont

o

it

. Ra i

ndrop

s , w aterspr a y,

ju

ice,c o ffee,s

t

eam,

pers p i ra

t

i

o n ,etc.m a y a

ls

o ca u s e a malfu n c

t

ion.

Kee p a c ce s s

orie

s tha t migh t b e s w

allowe

d awa y

fro

m

children.

Precautions

Warning: D

i

s p o s e o f

al

l u

se

d

batterie

s

i

n a

prope

r wast e

dispo

s a l

in

accordance with

local

regulation.

Used

batteries

must

not

be

discarded

in the normal

trash.

Preventive

Preventive Maintenance

Maintenance

The f o llo w i n g s

i

mple p

r

e ven

t

ive m a i n tena n ce

t

a

sk

s s h ou

l

d be perfo

r

m ed mont h l y to

e nsure c o nti

n

ued p e rfo

r

m ance of

t

he

de

v

i

ce a t m a x

i

m um ca

pac

i

t

y, and to red

uc

e the

po s s

ibil

i

t

y o f a

failure.

Mechanical

Mechanical Inspection

Inspection

C h e c k f or sp

l

i

t

s , c r a c k s, o r i m p

er

f

ec

t i on s i n th e c

a

se . I f y ou h a v e an y q ue s

tio

n s or

doubts,call y our service provider.

Cleaning

C l ean the out s ide

of

the

device

only,

u s i n g a

l

i

nt-free d ry c l ot h .

Do not a l

l

ow any liquid to enter

t

h e ca s e,and a v o i d

pourin

g

wate

r o r

other

l i qu i d s o n

th e

devi

c e

whil

e c l

eaning.

N ever u se a b r a s

i

v e s s u c h as w

i

r

e woo l or m e

ta

l po l

i

sh.

During c

l

ean

i

ng, m ake su

r

e you do not e x p o se

t

he d e v

i

ce

t

o t em peratu

r

es in e x

ces

s o f

45 ° C

(113

°

F).

10

Troubleshooting

Problem Possible Cause(s) Solution

Device does not send ECG

to application

The battery is very low or

depleted

Replace battery

The Bluetooth radio is not

enabled on the host device

Turn on the Bluetooth

radio in the iPhone

The user has not touched

both electrodes.

Ensure both electrode

pads are in contact with

the user ’ s skin

ECG Data is not being

analyzed

There is no connection to

the internet

Turn on your cellular data

or connect to a wifi access

point

ECG analysis comes back

with a bad recording

Too much noise or

movement in the

recording

Do not move & remain

still while the device is

recording

Not enough ECG data was

collected

Keep the device in contact

with the skin for 30

seconds

iPhone is running slowly Too many applications

open

Manually close the iOS

applications or restart

your phone.

ECG Check application

does not launch

Too many applications

open

Manually close the iOS

applications not in use or

restart your phone.

Cardiac Designs ECG Check User manual

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