Cardionet 1012 User Manual

PHYSICIAN’S

INSERVICE

MANUAL

Model CN1006

(C5)

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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.

Scope: Model CN1006 contains Model # 100-0025-01. This Manual contains all the user
instructions/information for Model # 100-0025-01.

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

©CardioNet, Inc. All rights reserved.

– 220-0083-01 - Revision B

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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
13
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
15
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

At Home or Away

Event Detection and

Transmission

24/7/365

CardioNet Analysis

Response, Reporting

MD Telemetry Reports

by Internet, Fax



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.

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. The sensor is capable of storing up to 4.5 hours of ECG
data in the event that it is temporarily out of communications range with the monitor.

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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