Cardionet 1011 User Manual

PHYSICIAN’S

INSERVICE

MANUAL

Model CN1006

(C5)

CONTACT INFORMATION

CardioNet Monitoring Center

Tel. [phone]

• For all clinical issues

• To extend or discontinue monitoring service

• For “fetch requests” for additional ECG data

Main Business Number
Tel. [phone]

• For non-clinical issues

Physician Relations Hotline
Tel. [phone]

• Assistance with physician reimbursement for interpretation of MCOT

To Fax in a Prescription

• Use the number printed at the top of the Patient Prescription/Order Forms provided to
your practice. Additional forms are also available from your CardioNet Account
Executive.

Caution: Federal law restricts this device to sale or use by or on the order of a physician or other

authorized health practitioner.

©CardioNet, Inc. All rights reserved.

– 220-0083-01 - Revision A

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CONTENTS

CARDIONET: MOBILE CARDIAC OUTPATIENT TELEMETRY 4
TECHNOLOGY OVERVIEW
SERVICE OVERVIEW
PHYSICIAN REPORTS
PRESCRIBING CARDIONET
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTOR
FOR USE ON ALL PATIENTS
TECHNICAL SPECIFICATIONS
TECHNICAL SPECIFICATIONS
IN-HOME REQUIREMENTS
FCC COMPLIANCE
ARRHYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS
HEART RATE MEASUREMENT REPORT
FCC RULES PART 68
REN
SERVICE

5
6
7
8
8

9
10
11
12
13
13
13
13
14
14

DISRUPTION OF THE NETWORK
FCC RADIO FREQUENCY EXPOSURE INFORMATION
BODY-WORN OPERATION
PACEMAKER DETECTION RESULTS
FCC COMPLIANCE
FCC RULES PART 15
PRECAUTIONS
CAUTIONS AND WARNINGS

14
14
15
15
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15
15
16

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CARDIONET: MOBILE CARDIAC OUTPATIENT TELEMETRY

CardioNet developed and introduced a new, integrated technology and service – Mobile Cardiac
Outpatient Telemetry – which allows heartbeat-by-heartbeat ECG monitoring, analysis and
response, at home or away, 24/7/365.

Heartbeat By

Heartbeat

Surveillance

CardioNet’s Mobile Cardiac Outpatient Telemetry (MCOT) assists physicians in the diagnosis
and management of difficult-to-diagnose arrhythmias. Given the infrequent and asymptomatic
nature of some arrhythmias, it is often challenging to capture an event with conventional
monitoring technology, such as Holter and cardiac event monitoring.

At Home or Away

Event Detection and

Transmission

24/7/365

CardioNet Analysis

Response, Reporting

MD Telemetry Reports

by Internet, Fax

The CardioNet System detects and transmits both symptomatic and asymptomatic
arrhythmias, based on monitoring parameters defined by the prescribing physician. Patients
are not required to sense or transmit events. However, if patients feel symptoms they can use
the touch screen on the CardioNet monitor to enter their symptoms and activity level, which
are transmitted to the CardioNet Monitoring Center along with their ECG. The physician
receives a daily telemetry report containing a representative ECG strip of the events detected;
a time and date stamp of the event, including any reported symptoms and activity.

The CardioNet device retains up to 720 hours of ECG data on each patient, allowing
physicians to request additional data through “fetch” requests to the CardioNet Monitoring
Center.

CardioNet MCOT offers physicians a powerful new diagnostic and patient management tool for
a wide range of monitoring indications.

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TECHNOLOGY OVERVIEW

CardioNet integrates patient monitoring, wireless communications technology, and the Internet
to allow cardiac rhythm related problems to be quickly identified, quantified, and treated.

The CardioNet System is comprised of a sensor with three leadwires, a monitor, and base.
The lightweight sensor (invisible under clothing) is worn by the patient. It continuously records
and analyses two channels of ECG and transmits the ECG by a radio frequency (RF) link to
the monitor.

The monitor is approximately the size of a PDA device. It has a powerful microprocessor,
extensive memory, embedded algorithm, LCD display, and wireless modem. The monitor is
powered by a rechargeable lithium battery, which powers the monitor for at least 10 hours.

The C5 monitor’s microprocessor is programmed with an algorithm that identifies arrhythmias
according to parameters selected by the prescribing physician. The standard algorithm
detection parameters and physician notification criteria established by CardioNet’s Medical
Advisory Board can be individualized for each patient, practice and physician.

The sensor continuously acquires the patient’s ECG in real time, and regularly transmits this
information to the monitor. When an abnormal rhythm has been identified or when the patient
enters a symptom, the data is transmitted to the CardioNet Monitoring Center for review,
interpretation and response by a certified monitoring specialist.

When the patient is at home and base is in use, the patient’s telephone line may be used to
transmit the data. Cellular communication is the primary means used to transmit events. If an
event occurs when the patient is in an area where cellular coverage is inadequate, the monitor
stores the data and transmits the event when the patient has moved into an area with cellular
coverage – or uses regular telephone lines to transmit the event once the monitor can
communicate with the base.

The CardioNet C5 Monitor stores a minimum of 30 days of the patient’s ECG data. Physicians
can request that CardioNet “fetch” additional data, beyond that contained in the Telemetry
Reports, by contacting the CardioNet Monitoring Center.

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SERVICE OVERVIEW

First, the prescribing physician is registered in the CardioNet service. All applicable contact
and demographic data is collected and entered into the CardioNet Patient Enrollment and
Management System (PEMS) by a CardioNet representative. When a physician identifies a
patient who is appropriate for CardioNet services, the practice faxes a Patient
Prescription/Order form to CardioNet along with the patient insurance information.

Important Information: Urgent Events
CardioNet is not an emergency response service. If patients experience symptoms that concern

them, they should seek medical help.
In the course of monitoring a patient’s heart, CardioNet may detect cardiac events which are

potentially life-threatening and which were not anticipated by the patient’s physician. As directed
in the Physician Notification Criteria, CardioNet will attempt to contact the physician and patient
if ordered.

CardioNet’s ability to obtain information regarding a cardiac event and to contact a patient or
his/her 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 standard telephone lines and/or 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 the patient or his/her physician

• If a patient or physician is not accessible by telephone,
CardioNet will not succeed in making contact with them

When CardioNet does detect a potentially serious cardiac event as defined by the patient’s
physician, we will attempt to contact the patient’s physician for direction. CardioNet will also
attempt to contact the patient and inform him/her of a cardiac event that has been received that
requires evaluation in the emergency room, per the physician’s notification criteria. The patient
may decide to seek medical help by calling EMS directly or the patient may ask that CardioNet
assist them in contacting EMS.

In all cases, due to the limitations of the CardioNet service as described above, patients should
not delay seeking medical help if they experience symptoms that concern them and are so
instructed in the Patient Education Guide. Also, patients are instructed in the Patient Education
Guide not to rely on CardioNet as an emergency response service.

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