Cardionet 1014 User Manual

Model(s): 100-0025-01, 900-0604-00

Certification Exhibit

FCC ID: QBI-1014

FCC Rule Part: 15.247

ACS Project: 16-2030

Manufacturer: Cardionet

User Manual

3998 FAU Blvd. Suite 310 Boca Raton, FL 33431 Tel: [phone] Fax: [phone]

MOBILE CARDIAC OUTPATIENT TELEMETRY

CARDIONET MCOT TM

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MANUAL

Mobile Cardiac Outpatient Telemetry™

Better Detection. Better Repor

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CARDIONET LIMITED WARRANTY

CardioNet produc ts are warranted to be free from manufacturing and material defects for a
period of one (1) year from the date of shipment from CardioNet to the original purchaser.
This warranty does not apply to any product which CardioNet determines has been modied
or damaged by the customer. Excluded from this warranty are expendable supply items
including, but not limited to, electrodes, lead wires, and batteries. Except for the express
warranties stated above, CardioNet disclaims all warranties including implied warranties
of merchantability and tness. The stated express warranties are in lieu of all obligations of
liabilities on the par t of CardioNet for damages, including but not limited to, special indirect
or consequential, arising out of or in connection with the use or per formance of CardioNet
products. Any action for breach of warranty shall be commenced within one (1) year of said
breach or be forever barred. Any repairs made to the produc t, which are not covered by
the warranty, shall be billed to the customer. Device is to be serviced by Factory Authorized
Technicians only. Do not attempt to repair, modif y, or service the CardioNet CN1006 MCOT
system. Do not attempt to open or tamper with MCOT System. Opening the case will void
product warranty.

MOBILE CARDIAC OUTPATIENT TELEMETRY

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TABLE OF CONTENTS

01. OVERVIEW....................................................................................... 1

02. INDICATIONS FOR USE.................................................................. 2

03. PRECAUTIONS................................................................................ 4

04. CAUTIONS....................................................................................... 5

05. WARNINGS...................................................................................... 6

06. MEDICAL PRACTICE INSTRUCTIONS........................................... 7

07. KIT CONTENTS................................................................................ 8

08. MONITOR AND SENSOR................................................................ 9

09. ATTACHING THE ELECTRODES & SENSOR TO YOUR SKIN........ 10

10. GETTING STARTED WITH MONITORING...................................... 12

11. RECORDING SYMPTOMS............................................................... 13

12. CHARGING THE CARDIONET MONITOR...................................... 14

13. RECEIVING TEXT MESSAGES......................................................... 15

14. SKIN CARE & REPLACING ELECTRODES...................................... 16

15. SHOWERING, BATHING AND SWIMMING.................................... 17

16. TROUBLESHOOTING....................................................................... 18

17. RETURNING THE UNIT.................................................................... 19

18. EQUIPMENT SYMBOLS................................................................... 20

19. SPECIFICATIONS.............................................................................. 21

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CARDIONET MCOT

CARDIONET MCOT

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MANUAL

MANUAL

01.

OVERVIEW

The CardioNet Mobile Cardiac Outpatient Telemetry
ECG Monitor with the capability to detect cardiac arrhythmias and transmit ECG data to a
staed Monitoring center.

The subject device is comprised of two (2) main components: 1) a patient-worn Sensor, and

2) a Monitor

A Sensor acquires the ECG signal from the patient’s body and transmits the signal to a
PDA sized Monitor where the data is stored and analyzed by an automated arrhythmia
detection algorithm residing in the Monitor. When events are detected by the analysis
algorithm or when indicated by the patient pressing the Record Symptom button on the
Monitor, the Monitor will transmit the data to the Monitoring Center. Data is uploaded
to the Monitoring Center via Cellular RF modem transmission. The data is received and
reviewed by trained technicians at the Monitoring Center.

Caution: U.S. federal law restricts this device to sale by or on the order of a physician.

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(MCOT TM) system is an ambulatory

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MOBILE CARDIAC OUTPATIENT TELEMETRY

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02.

INDICATIONS FOR USE

1. Patients who have a demonstrated need for cardiac monitoring. These may include but are
not limited to patients who require monitoring for: a) non-life threatening arrhythmias such
as supraventricular tachycardias (e.g. atrial brillation, atrial utter, PACs, PSVT) and ventricular
ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after
cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid
conditions such as hyperthyroidism or chronic lung disease

2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not
limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology
in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).

3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm
with symptoms.

4. Patients who require monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and
potential proarrhythmic eects of membrane active drugs, b) Monitoring of eect of drugs to
control ventricular rate in various atrial arrhythmias (e.g. atrial brillation).

5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.

6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central)
to evaluate possible nocturnal arrhythmias.

7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia,
possibly secondary to atrial brillation or atrial utter.

8. Patients requiring measurement, analysis and reporting of QT interval, excluding patients with
a documented history of sustained atrial brillation or atrial utter.

9. Patient who require monitoring for potential arrhythmias based on risk factors (e.g. atrial brillation).

10. Patients requiring measurement of ST segment changes. The device is not intended to

sound any alarms for ST segment changes.

CARDIONET MCOT

CONTRAINDICATIONS:

1.Patients with potentially life-threatening arrhythmias who require inpatient monitoring.

2.Patients who the attending physician thinks should be hospitalized.

3.This device should not be used for monitoring of QT interval during the initiation of

antiarrhythmic therapy, where in-hospital monitoring is required by the labeling of that drug.

4.The device does not replace the QT interval measurement by a trained observer using

diagnostic 12-lead ECG in a clinical environment. This device is not intended to sound any

alarms for QT interval changes.

5.The device does not annotate QT interval for QRS durations >160 ms or for T wave amplitudes

≤5% of the peak QRS amplitude.

FOR USE ON ADULT AND PEDIATRIC PATIENTS ONLY

The CardioNet MCOT System is intended for use on adults and children. It is not intended to be

used on infants weighing less than 10kg (22 lbs).

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MANUAL

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MOBILE CARDIAC OUTPATIENT TELEMETRY

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03.

PRECAUTIONS

A. DISPOSE OF BATTERIES PROPERLY

Observe all local laws for the disposal of alkaline batteries.

B. WHEN NOT IN USE, REMOVE SENSOR BATTERY

Do not leave the battery in the Sensor when it is not in use.

C. AVOID ELECTROMAGNETIC INTERFERENCE

For the best recording results, you should avoid close proximity to heavy equipment or other
sources of electromagnetic interference such as electric blankets, heating pads, water beds, etc.

D. POTENTIAL FOR ELECTROMAGNETIC INTERFERENCE

There is a potential for electromagnetic interference to other devices while using
the CardioNet Service.

E. USE WITH IMPLANTED PACEMAKERS AND ICDs ( DEFIBRILLATORS)

If you have an implanted pacemaker or defibrillator (ICD), the manufacturer may have
recommended you take certain precautions when using a cellular phone. Since the CardioNet
Monitor contains a cellular phone, you should take the same precautions when carrying and
using the Monitor. In general, most manufacturers recommend the following:

• You should keep a distance of at least six inches (15 cm) between the cellular phone
and a pacemaker or debrillator.

• You should hold the cellular phone on the opposite side of the body from the
pacemaker or debrillator.

• Do not carry a cellular phone in a breast pocket or on a belt if that would place
the phone within six inches of the pacemaker or debrillator.

• You should refer to the manufacturer’s information for guidance regarding
your pacemaker or ICD and interference issues.

CARDIONET MCOT

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MANUAL

04.

CAUTIONS

A.POWER DOWN MONITOR AND SENSOR BEFORE SHOWERING

Power down the Monitor, remove the Sensor, and remove battery from Sensor
before showering. The CardioNet Sensor is water resistant, not waterproof.

B. DO NOT GET THE MONITOR AND SENSOR WET

Make sure the Monitor and Sensor stay dry at all times.

C. CLEANING

Use a soft cloth to clean the equipment.

D. LIMITATIONS OF COVERAGE

CardioNet’s ability to obtain information regarding a cardiac event and to contact you
or your physician in a timely manner is limited by a number of factors including:

• Transmission of information about a cardiac event to CardioNet‘s Monitoring

Center is potentially limited by the availability of cellular phone coverage.

• There is an inherent time delay from the time that an event is detected to when the

events are analyzed and confirmed by a Certified Cardiac Technician (CCT).

• There is an inherent time delay from when the event is analyzed and confirmed by

the CCT to when CardioNet is able to make contact with you or your physician.

• If you or your physician are not accessible by telephone, CardioNet will not

succeed in making contact with you or your physician.

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