Cardionet 1006 Monitor User Manual PIM revB

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physicians instruction manual

CONTENTS

Contact Information ................................................................................ 2

Introduction ............................................................................................. 3

Product Description ................................................................................. 4

Service Overview ..................................................................................... 6

Patient Enrollment ................................................................................... 8

Electronic Patient Enrollment ................................................................ 10

Indications and Contraindications.......................................................... 11

Reports .................................................................................................. 12

Physician Notification ............................................................................ 14

Billing ..................................................................................................... 15

Cautions and Warnings .......................................................................... 17

Technical Specifications ......................................................................... 19

Sample Forms and Reports ................................................................... 28

DRAFT

Lit Number - 100327 !!

Revision E !!

February 2004

Caution: Federal law restricts this device

to sale by or on the order of a physician.

CONTACT INFORMATION

Main Number (215) 689-7450

(866) 426-4404

Patient Service Center (866) 727-3397 Physician Notification

(866) 426-4401 Patient Inquiries

Enrollment (866) 426-4403 Fax

Billing (866) 426-4402

INTRODUCTION

CardioNet: Mobile Cardiac Outpatient Telemetry

CardioNet has developed 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.

CardioNet’s Mobile Cardiac Outpatient Telemetry 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 actual arrhythmia with conventional

monitoring technology, such as Holter and cardiac event monitoring.

With the CardioNet System, we are able to automatically detect and

capture asymptomatic and symptomatic arrhythmias, based on

monitoring parameters defined by the prescribing physician. In

addition, the patient can utilize the touch screen on the CardioNet

monitor to enter

their symptoms and activity level at the time

of a documented event. The physician then

receives a representative ECG strip of the

event; a time and date stamp of the actual

event, including symptoms and activity, and is

therefore able to make a more informed and

accurate diagnosis.

CardioNet outpatient

telemetry offers

physicians a powerful

new diagnostic and

patient management

tool for a wide range of

monitoring indications.

Physician Receives

CardioNet Report

Patient Enters Symptoms

and Activities

Patient Monitored

24/7/365

PRODUCT DESCRIPTION

CardioNet merges patient monitoring, wireless communications,

and the Internet to allow targeted cardiac rhythm related problems

to be identified, quantified, and communicated to the prescribing

physician in a timely and efficient manner.

The CardioNet System is comprised of a sensor, monitor, and base.

The lightweight sensor is worn by the patient on a lanyard or belt

clip, it continuously records two channels of ECG, and transmits the

ECG by a radio frequency (RF) link to the monitor. The sensor is

hours. While using the sensor, the patient is required to wear (3)

disposable electrodes to record their ECG.

The monitor is approximately the size of a PDA device. It has a

powerful microprocessor, extensive memory, imbedded algorithm,

LCD display, wireless modem, and a global positioning system

(GPS). The monitor is powered by a rechargeable lithium battery,

which typically lasts 18 hours.

The monitor’s microprocessor is programmed to identify cardiac

rhythm problems within guidelines established by the prescribing

physician. The algorithm detection parameters and physician

notification criteria are individualized for each patient and physician.

Sensor with Lead Wires

The monitor continuously analyzes the ECG in real time as it is

transmitted from the sensor. When an abnormal rhythm has been

identified based on the monitoring parameters, the data is automatically

sent via a wireless modem to the CardioNet Patient Service Center for

additional review and interpretation by a certified monitoring specialist.

In the case of a patient-initiated event, the monitor automatically

prompts the patient to enter their symptoms and activities from a

predetermined list on the touch screen display.

When the patient is at home and an event occurs while the monitor is in

the base, the patient’s normal telephone line is used to transmit the

data. If an event occurs when the patient is in an area where cellular

coverage is inadequate, the patient may elect to transmit their ECG

directly, using a regular telephone.

The base utilizes an AC power supply and is connected to the patient’s

telephone line. The base also consists of two antennas, which allows the

patient to have an expanded RF range within their home. When the

patient is mobile, the RF range or leash length between the monitor and

sensor is estimated to be 25-50 feet. The sensor and monitor are

designed to alert the patient if and when they are out of RF range or

cellular coverage.

The CardioNet monitor has sufficient memory to store a minimum of

twenty-four hours of the patient’s ECG. A daily protocol exists to upload

the patient’s 24-hour ECG data, including related events and trends from

the monitor to the Patient Service Center.

CardioNet Monitor in Base

SERVICE OVERVIEW

First, the prescribing physician is registered in the CardioNet service. All

applicable contact and demographic data is collected and inputted 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, a patient enrollment is initiated by

his/her office, included is patient demographics, insurance information,

indications for usage, duration, thresholds, and medical necessity where

applicable. Upon completion, the enrollment form is submitted to the

Patient Service Center – either by fax or Internet.

For non Medicare patients, the physician practice may utilize the CPT

code 93799-26 when billing for the professional interpretation,

including the narrative description “ECG arrhythmia detection and alarm

system.” An individual payor may establish or recommend alternative

codes to be used to reflect the professional interpretation for CardioNet

related services. The physician practice may wish to contact their

provider representative to establish the appropriate billing requirements

for CardioNet.

Additionally, if you are currently required by the payor to provide a

referral through the payor system you should continue to follow that

procedure. Also if you are required to contact the payor for pre-

authorization/authorization to provide professional interpretation for

diagnostic services continue to do so, this will also apply to CardioNet.

When speaking to a payor or claims representative, it is important to

note that CardioNet is not a Holter or event monitor. CardioNet mobile

telemetry is a unique, proprietary technology and service offering, and

is not the equivalent of any other monitoring technology or service.

CardioNet will provide an in-home patient educator to train the patient

on the use of the CardioNet System. CardioNet has a wealth of

resources including in-home educators and print and video training

tools to insure the highest level of patient confidence and compliance.

Important

CardioNet outpatient telemetry is a diagnostic service, not an

emergency response service. It is possible, however, that a patient may

develop a life-threatening arrhythmia while on our service. If we detect

such an event, CardioNet will attempt to assist the patient in accessing

EMS services. Physicians should be aware that our ability to assist

ambulatory patients is limited by many factors including cell phone

coverage, the inherent limitations of GPS locating technology and local

EMS policies.

CardioNet provides a

wealth of educational

tools, including the

Patient Education Guide,

the Patient Pocket Guide,

and a video.

The CardioNet Patient Service Center is staffed

with highly qualified and experienced cardiac

monitoring specialists. At a minimum, all

monitoring specialists are CCT certified. They have extensive

experience in cardiovascular monitoring; including the hospital based

C.C.U. and I.C.U. telemetry, emergency medical services, and other

cardiac call center environments.

As a Medicare provider, CardioNet is licensed as an Independent

Diagnostic Testing Facility (IDTF).

The CardioNet monitoring specialists serve a vital role in responding to

patient and monitor initiated cardiac events. The monitoring specialists

provide a thorough preliminary analysis of the patient’s ECG to insure

that the data is accurate and presented in the appropriate time and

manner as requested by the physician.

All calls are monitored and recorded for quality assurance. CardioNet

requires that all monitoring specialists participate in additional training

and educational programs. A continuous QA process has been

established for all facets of the service center operation.

The monitoring specialists, based on defined physician guidelines,

prepare daily patient summary reports for final physician review and

interpretation. In the case of a patient notification threshold event, the

prescribing physician is contacted immediately and an urgent report is

submitted for review and interpretation. Reports are tailored to the

needs and requirements of the physician and are sent via the Internet,

facsimile, or standard mail.

The CardioNet Patient Service Center is fully staffed and available 7x24,

365 days of the year.

Monitoring Specialists Review

and Interpret Data to Ensure

Accuracy

PATIENT ENROLLMENT

The Patient Enrollment Form is located in the CardioNet Patient

Enrollment and Management System (PEMS). The client can access the

CardioNet Patient Enrollment and Management System application at

www.cardionet.com. This is a secure and restricted website and the user

is required to be enrolled as a CardioNet client. Forms are also available

from the CardioNet Patient Service Center. If you are not a CardioNet

registered user, please contact the Patient Service Center.

Password

Please enter your username and password to log in.

Username

After you have entered your user name and password, click the log in

button on your screen. You now have access to the CardioNet Patient

Enrollment and Management System. The name of the client, physician

or practice should appear on the upper left of the PEMS application.

You may also refer to the CardioNet

Quick Start Guide

for instructions

on enrolling a patient.

Using the CardioNet navigational tree on the left side, click on

Documents and Forms. A document tab will open with a list of

applicable forms. Click on

Patient Enrollment Form

(MON300) and print

a copy. Follow the same process and procedure for

Patient Prescription

Form

(MON302)

Each form must be completed to enroll a patient on

CardioNet’s service.

The Patient Enrollment Form includes patient demographics,

emergency information, primary and secondary insurance, patient

waiver and assignment of benefits. Using this form please input all the

appropriate information in the fields listed. In addition to any insurance

information that is listed on the form, please provide CardioNet with a

copy (front and back) of the patient’s insurance card.

The patient’s signature is required on all enrollment forms prior to

submitting to CardioNet.

CardioNet Patient

Enrollment and

Management System.

The

Patient Prescription Form

includes the patient name, prescribing

physician, physician group name, and duration of monitoring requested,

diagnosis and ICD-9 code. Using this form input all the appropriate

information in the fields listed. The prescribing physician is required

sign the CardioNet

Patient Prescription Form

prior to enrolling

the patient.

Please fax both completed forms, including a copy of the patient’s

insurance card to the CardioNet Patient Service Center.

The enrollment information will be entered into the CardioNet patient

database; the patient’s insurance carrier will be contacted for

preauthorization as required, upon approval, the delivery of the

CardioNet System will be scheduled as soon as possible.

Please see “Sample Forms and Reports” section of this manual for

examples of reports and forms.

ELECTRONIC PATIENT ENROLLMENT

CardioNet provides an additional method for enrolling patients in our

service, electronic enrollment. If the user prefers to use CardioNet’s

electronic enrollment process, you can access the CardioNet Patient

Enrollment and Management System (PEMS) application at

www.cardionet.com. Use the Physician Log In and enter the username

and password, and then click on Enroll Patient. The application will open

to Patient Demographics. Please be advised that all fields and

applicable tabs (Emergency and Insurance Information) must be

completed prior to submitting an electronic enrollment.

Note: Electronic Patient Enrollment is not currently an active

application in PEMS.

Enroll Patient Online

CARDIONET AMBULATORY ECG MONITOR

WITH ARRHYTHMIA DETECTOR

Indications for Use

1. Patients who have demonstrated a need for cardiac monitoring and

are at low risk of developing primary ventricular fibrillation or

sustained ventricular tachycardia

2. Patients with dizziness or light-headedness

3. Patients with palpitations

4. Patients with syncope of unknown etiology

5. Patients who require monitoring for non life-threatening arrhythmias,

such as atrial fibrillation, other supraventricular arrhythmias,

evaluation of various bradyarrhythmias and intermittent

bundle branch block. This includes postoperative monitoring for

these rhythms

6. Patients recovering from coronary artery bypass graft (CABG) surgery

who require monitoring for arrhythmias

7. Patients requiring monitoring for arrhythmias inducing co-morbid

conditions such as hyperthyroidism or chronic lung disease

8. Patients with obstructive sleep apnea to evaluate possible

nocturnal arrhythmias

9. Patients requiring arrhythmia evaluation for etiology of stroke or

transient cerebral ischemia, possibly secondary to atrial fibrillation

10. Data from the device may be used by another device to analyze

measure or report QT interval. The device is not intended to sound

any alarms for QT interval changes.

Contraindications

1. Patients who have a history of sustained ventricular tachycardia or a

documented occurrence of ventricular fibrillation

2. Patients who the attending physician thinks will be at risk for

ventricular tachycardia or ventricular fibrillation as indicated

by the following:

!A measured ejection fraction of less than 35% with complex

ventricular ectopic activity (>= 10 PVCs per hour or

repetitive PVCs)

!Unstable angina defined as chest pain at rest, a new onset of

angina, or a change in existing patterns of angina

!Patients with a recent (<= 3 months) myocardial infarction (MI)

!Patients who are candidates for or have had recent heart

valve surgery

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

REPORTS

When a physician group and/or physician is enrolled in CardioNet’s

service, preferred reporting methods for different events (Internet,

fax, mail or telephone) are established for each physician user.

Physicians may elect to modify or change their preferred report

delivery methods by selecting “Modify Physician” in the CardioNet

Patient Enrollment and Management System, or contacting the

CardioNet Patient Service Center directly.

Fax or mail reports are forwarded to the physician by the CardioNet

Patient Service Center. To access Patient Reports using PEMS, the user

must log in to

www.cardionet.com. .

. .

. Use the Physician Log In, and enter

the user name and password. The name of the physician practice or

physician will appear in the top left of your screen. Using the

navigational tool bar on the left side, please click on Active Patients.

A list of all active patients will appear under the Patient Reports tab.

Included with a list of active patients will be the type of report, date of

report, report delivery method, time and date the report was sent from

the Patient Service Center, and a confirmation to indicate that the user

has either read or needs to review the report listed. To select a patient

report you wish to review, click on the patient’s name.

Note: The user must have Adobe Acrobat Reader in order to view and

print a CardioNet patient report.

CardioNet provides reports for physician review, such as the:

Urgent Notification Mobile Telemetry

and

Daily Mobile Telemetry

Urgent Report

is provided to the physician when a patient has an

event, symptomatic or asymptomatic, that meets the physician defined

notification threshold. The

Daily Report

is provided to the prescribing

physician for each day the patient is on service with CardioNet. The

Daily Report

includes a heart rate trend graph and selected patient

events for the previous 24-hour period.

A Representative ECG for the Urgent Report

The

Urgent Report

provides a six second sample of the patient’s ECG,

Channel 1 and 2. The report includes a time and date stamp of the

actual event, preliminary findings of the CardioNet monitoring

specialist, symptoms and activities reported by the patient, and how the

event was initiated, automatic or patient initiated.

Note: The Patient Service Center has an established procedure for

contacting the prescribing physician in advance of receiving an

Urgent Notification Mobile Telemetry Report

. Escalation and notification

protocols have been approved by the Patient Center Medical Director to

deal with Emergency, Urgent, and Daily patient events. Refer to

Physician Notification Order Form

(MON305).

Each client or physician as

part of the CardioNet enrollment process is responsible for providing

appropriate contact numbers for normal business hours, after hours,

weekends and holidays.

The client or physician user can request additional ECG data from the

Patient Service Center to support a particular event or report.

Please see “Sample Forms and Reports” section of this manual for

examples of reports and forms.

PHYSICIAN NOTIFICATION

As part of the CardioNet client enrollment process, the Physician

Notification criteria will be established for the client (physician practice)

or individual prescribing physician. The

Physician Notification Order

Form

(MON305) is to be completed and signed prior to enrolling a

patient on CardioNet’s service. CardioNet’s Medical Advisory Board

provides a set of default values based on established clinical practice

monitoring guidelines.

An Emergency notification threshold cannot be downgraded for

physician notification purposes. The physician may elect to change

or modify an Urgent or Daily patient event threshold to a higher

priority notification.

Please see “Sample Forms and Reports” section of this manual for

examples of reports and forms.

Modifying Physician Notification

A physician may request that the notification criteria be changed or

modified for a particular patient at the time a patient is enrolled or

during the course of monitoring. If the patient is being actively

monitored, the client must complete and sign a

Physician Notification

Change Order (

MON306)

Upon receipt of the form by the Patient

Service Center, it will be reviewed and approved by a clinical manager.

The change will be noted in the patient’s medical record and the

monitor will be reconfigured to reflect the change where applicable.

The

Patient Prescription Form

(MON302)

should be used when enrolling

a new patient on the CardioNet service. Refer to Patient Enrollment.

BILLING

The patient is responsible for providing the CardioNet Patient Service

Center with all applicable insurance information at the time of

enrollment. CardioNet will bill the patient’s primary insurance company.

In addition, CardioNet will also bill the secondary insurance company, if

provided by the patient. A copy of the patient’s insurance card is to be

provided with the enrollment. The patient/responsible party/legal

guardian is required to sign the Patient Enrollment Form.

CardioNet will bill the insurance company for only those services

provided directly by CardioNet to the patient. In most cases, this is

defined as the technical component, which includes monitoring and all

equipment required to monitor the patient. The physician is responsible

for billing the patient’s insurance carrier for the professional component,

which is defined as the physician interpretation.

Insurance Verification and Benefit

CardioNet requires that a patient’s insurance coverage is confirmed and

benefits are verified. If the insurance verification determines that

services requires a pre-authorization CardioNet takes the appropriate

step to comply with the insurance company. It is imperative that the

Physician always complies with the requirements of the Insurance

Company regarding the referral process and subsequent pre-

authorization/authorization as determined by the patient/members

benefit plan. If additional information (certificate of medical necessity,

etc.) by the insurance company is required to obtain authorization,

CardioNet will immediately contact the prescribing physician. If

CardioNet is not able to obtain authorization from the insurance

company to provide services for the patient, the prescribing physician

and patient will be notified immediately. The patient may then elect to

continue on service with CardioNet, and therefore would assume 100%

financial responsibility for all related charges.

CardioNet has established an appropriate set-up and technical fee for

Mobile Cardiac Outpatient Telemetry. Medicare in the state of

Pennsylvania established a new policy (M-60) on February 11, 2002, to

address “Real-Time Cardiac Surveillance System.” Please review the

LMRP M-60 policy description, indications and limitations, and/or

medical necessity.

Physician Reimbursement Coding Guidelines

The LMRP determined that no existing CPT code fully and accurately

describes this new technology; therefore services should be reported

by using CPT Code 93799 and include the narrative “ECG arrhythmia

detection and alarm system.” Providers are instructed to bill one (1) unit

of procedure code 93799, per day of cardiac surveillance.

The TC (Technical) and 26 (Professional) modifiers should be used

with CPT Code 93799 to identify what component of the monitoring

was performed.

The Professional Component includes review and interpretation of each

24-hour cardiac surveillance as well as 24-hour availability and response

to surveillance events.

CardioNet, based on relevant policies and procedures from all non-

Medicare insurance providers, will bill for its services in a similar manner,

unless otherwise instructed.

Patient Responsibility

CardioNet has established an initial set-up and technical fee for Mobile

Cardiac Outpatient Telemetry. CardioNet will bill the patient’s insurance

company for the intended service duration as defined by the

prescribing physician. In certain instances, the patient’s insurance

company may regard CardioNet as an

out of network

provider. It is not

our intent to penalize the patient if their insurance company regards

CardioNet as an out of network provider. CardioNet will continue to bill

and collect from the patient all applicable co-payments and

deductibles. CardioNet will make every reasonable effort to insure that

the patient’s financial responsibility will not exceed their normal

in plan

benefits. With the exception of Medicare, CardioNet will obtain

insurance pre-authorization for all services to be provided by CardioNet.

All services will be billed to the applicable parties upon completion of

the prescribed service period, or upon discontinuation of service as

requested by the physician, patient, or insurance company.

PRECAUTIONS

Dispose of Batteries Properly

Observe all local laws for the disposal of alkaline batteries.

When Not in Use, Remove Sensor Battery

Do not leave the battery in the sensor when it is not in use. Damage

from corrosion could result.

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.

Potential for Electromagnetic Interference

There is a potential for electromagnetic interference to other devices

while using the CardioNet service.

The CardioNet system 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:

! Keep a distance of at least six inches (15 cm) between the cellular

phone and a pacemaker or defibrillator.

!Hold the cellular phone on the opposite side of the body from the

pacemaker or defibrillator.

!Don’t 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

defibrillator.

CAUTIONS AND WARNINGS

Caution: Power Down and Remove Sensor Before Showering

Power down the monitor and remove the sensor before showering.

While the CardioNet sensor and monitor are water resistant, they are not

waterproof. Refer to the Patient Education Guide for complete

instruction on removal and reapplication before showering.

Caution: Do Not Get the Monitor and Sensor Wet

Make sure the monitor and sensor stay dry at all times.

Warning: For Adult Use Only

The CardioNet Monitoring System is intended for Adult use only. It shall

not be used on infants weighing less than 22 lbs.

Warning: Use with Telephone System

Any patient whose life may be put at significant risk by the unavailability

of the telephone system should not be monitored by the CardioNet

System.

Warning: Not an Apnea Monitor

The CardioNet monitor is not to be used as an apnea monitor.

Warning: Use Only CardioNet Electrodes

While wearing the CardioNet sensor, use only electrodes provided by

CardioNet.

Warning: Do Not Tamper

There are no serviceable parts in the CardioNet System. Removing the

cover of any of component may alter performance.

Warning: Do Not Tamper with Monitor Battery

The monitor battery can present a fire or chemical burn hazard if

mistreated. Do not disassemble, heat above 80C (176 F), incinerate, or

recharge using any device other than the base.

Warning: Use Only CardioNet Wall Adapter

Do not use any wall adapter for the base other than the one provided in

the CardioNet Service Kit.

Warning: Do Not Connect Any Device to the PC Port on the

Back of the Base

The PC port is to be used only by CardioNet personnel.

TECHNICAL SPECIFICATIONS

Physical

Sensor

2.7 in. x 0.9 in height

Weight: 2.2 oz

Sensor neck strap

24 in.

Monitor

5.8 in x 3.0 in x 1.1 in

Weight: 12.8 oz

LCD

3.0 x 2.3, touch screen, monochrome, backlight

Base

7.8 in x 4.3 in x 6.1 in

Weight: 13.3 oz

Functional

Sample Rate 250 samples per second

Resolution 12 bits

Dynamic Range + / -5 mV

Bandwidth 0.5 to 40 Hz

Channels 2

Battery Life Monitor: (12-16 hours average with cleared memory

and fully recharged battery), rechargeable Sensor:

(24 hr) AA Alkaline

Leakage current Less than .1 µ V Electrodes

Transmission

Sensor to Monitor 900 MHz ISM band RF transmission, digital error cor-

rected. 30 foot range, retransmission if data is corrupted.

Monitor to Center CDMA (PCS & cellular) wireless, digital error corrected.

Telephone line modem, digital error corrected. Acoustic

transmission, 1500 Hz center frequency, 8 bits resolution,

5 mV dynamic range. ECG recording intervals vary by

type of event; the minimum is 15 seconds pre-event and

45 seconds post event. Wireless transmission subject to

coverage of cellular network. Data received at Monitoring

Center within minutes with good wireless coverage and/or

modem communications. Urgent reports processed at

time of data receipt. Daily reports processed once

a day, by 3 PM.

Operating conditions

Operating temperature 20 - 45 o C

Operating humidity 10% - 95%, noncondensing

Storage temperature -20 - 55 o C, noncondensing

Storage humidity 5% - 95%, noncondensing

Operation altitude 700-1060 millibars

Fluid Ingress Rating IPX1

Note: Please protect the monitor and sensor from water and other fluids.

Connectors

Base Power in (15V, 1.2A max)

Phone in (RJ-11)

Phone out (RJ-11)

Monitor Power in (15V, 1.2A max)

Wall Adapter

Manufacturer Friwo, Inc. (15V, 1.0A)

Model number FW7555M/15

Note: Both the Monitor and Sensor are internally powered

continuous operation devices.

Standards Compliance

Monitor EN60601-1

AAMI EC-38

FCC parts 2, 15, 22, 24

Sensor EN60601-1

AAMI EC-38

FCC part 15

Base EN60950

AAMI EC-38

FCC part 15, 68

AECG Equipment Class II

Note: This equipment has been tested and found to comply with the limits

for medical devices to the IEC 601-1-2:1993, EN60601-1-2:1994, Medical

Device Directive 93/42/EEC or the Electromagnetic Compatibility

Directive 89/336/EEC (use applicable directive). These limits are

designed to provide reasonable protection against harmful interference in

a typical medical 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 other

devices in the vicinity. However, there is no guarantee that interference will

not occur in a particular installation. If this equipment does cause harmful

interference to other devices, 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 device.

! Increase the separation between the equipment.

! Connect the equipment into an outlet on a circuit

different from that to which the other device(s)

are connected.

! Consult the manufacturer or field service technician

for help

UL Listed

The CardioNet monitor and base have been tested to UL 2601,

No. EN60601-1.

The CardioNet base is compliant with EN60950.

EQUIPMENT SYMBOLS

Consult Manual

Year of Manufacture

Type BF Equipment

Serial Number

2000

HARDWARE REQUIREMENTS

In Home Requirements

Touch tone telephone

AC powered outlet

FCC ID

Sensor QBI-1007

Monitor QBI-1006

Monitor cell NBZNRM-6832

Base CARDT00B42061

ARRYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS

The CardioNet System incorporates an arrhythmia analysis algorithm

whose performance is presented below:

The algorithm results were obtained from the respective databases

in strict accordance with EC-57 and with 0% downtime on

both databases.

Performance Measure MIT Arrhythmia Database AHA Database

QRS Detection Sensitivity % 99.93 99.88

QRS Detection Positive Predictivity % 99.85 99.89

PVC Detection Sensitivity % 95.44 94.07

PVC Detection Positive Predictivity % 96.94 97.72

PVC Detection False Positive Rate % 0.229 0.222

HEART RATE MEASUREMENT REPORT

The performance of the analysis algorithm for heart rate detection on

standard databases is shown below. The average RMS errors for the

AHA, MIT-arrhythmia, and NST databases are 2.08%, 1.07%, and

30.9% respectively.

Heart Rate Calculation

The average heart rate is calculated by computing the mean of the actual

RR-intervals, in the last 6 seconds or 8 RR-intervals (whatever is shorter).

The actual RR intervals are calculated based on the QRS detected events:

Actual RR = the time between the last detected QRS complex

and the previously detected QRS complex, in milliseconds

In the CardioNet reports, the heart rate displayed on the ECG strips

themselves is the average of the rate for the beats displayed in that strip.

AHA ECG Database (Summary of results from 78 records)

ErrSum RefSu Nmeas MeanRefHR RMSerror(%)

Sum 130111.6913 2167402.8283 26706

Gross 81.15792.7197 2.7197

Average 81.4511 2.0762

MIT-BIH Arrhythmia Database (Summary of results from 44 records)

ErrSum RefSu Nmeas MeanRefHR RMSerror(%)

Sum 25694.4788 1016331.6122 13030

Gross 77.9994 1.8003

Average 78.0769 1.0691

NST Database (Summary of results from 12 records)

ErrSum RefSu Nmeas MeanRefHR RMSerror(%)

Sum 3098725.4772 266364.2826 3576

Gross 74.4867 39.5198

Average 74.4867 30.8921

RUN-BY-RUN REPORT

AHA ECG Database

Record CTs CFN CTp CFP STs SFN STp SFP LTs LFN LTp LFP CSe C+P SSe S+P LSe L+P

Sum 904 95 1048 35 379 85 487 12 26 53 75 4

Gross 90 97 82 98 33 95

Average 72 78 55 97 76 91

Total couplets: 999

Total short runs: 464

Total long runs: 79

MIT-BIH Arrhythmia Database

Record CTs CFN CTp CFP STs SFN STp SFP LTs LFN LTp LFP CSe C+P SSe S+P LSe L+P

Sum 564 84 575 35 32 20 42 5 10 3 15 0

Gross 87 94 62 89 77 100

Average 78 74 60 87 78 100

Total couplets: 648

Total short runs: 52

Total long runs: 13

VENTRICULAR FIBRILLATION EPISODE REPORT

AHA VF Detection

Record TPs FN TPp FP ESe E+P DSe D+P Ref duration Test duration

Sum 9 0 26 0 1:28:50.140 1:10:59.646

Gross 100 100 79 99

Average 100 100 77 96

Summary of results from 78 records

MIT-BIH Detection

Record TPs FN TPp FP ESe E+P DSe D+P Ref duration Test duration

Sum 1 0 1 0 1:37.900 1:44.032

Gross 100 100 91 86

Average 100 100 92 86

Summary of results from 44 records

CU Detection

Record TPs FN TPp FP ESe E+P DSe D+P Ref duration Test duration

Sum 26 5 28 2 40:38.772 24:55.332

Gross 84 93 53 86

Average 87 96 52 76

Summary of results from 30 records

PACEMAKER DETECTION RESULTS

Pacemaker detection: Meets AAMI EC38

FCC and Industry Canada (CS-03) Compliance

This device complies with part 15 and 68 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

interference received including interference that may cause undesired

operation.

FCC Rules Part 15

The Model 1001 has been tested and complies with the limits for a

class A digital device, pursuant to Part 15 of the FCC Rules. These

limits are designed to provide reasonable protection against harmful

interference when the equipment is operated in a residential

environment. This equipment generates, uses, and can radiate radio

frequency energy and, if not installed and used in accordance with the

instruction manual, can cause harmful interference to radio

communications.

CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY

CardioNet Inc. COULD VOID THE USER’S AUTHORITY TO OPERATE

THE EQUIPMENT.

FCC Rules Part 68

FCC Part 68 Registration

The Model 1001 complies with FCC Rules, Part 68. On this equipment

is a label that contains, among other information, the FCC Part 68

registration number.

REN

The ringer equivalence number (REN) is used to determine the quality

of devices that may be connected to the telephone line. Excessive

RENs on the telephone line may result in the devices not ringing in

response to an incoming call. In most, but not all areas, the sum of

RENs should not exceed five (5.0). To be certain of the number of

devices that may be connected to a line, as determined by the total

RENs, contact the local telephone company.

Note: RENs are associated with loop-start and ground-start ports. It is

not used for E&M and digital ports. The REN assigned to the Model

1001 is 0.01 B. If requested, this information must be given to the

telephone company.

Service

In the event of equipment malfunction, all repairs should be

performed by CardioNet Inc. or an authorized agent. It is the

responsibility of users requiring service to report the need for service

to CardioNet Inc. or to one of our authorized agents. Service can be

facilitated through our office at:

CardioNet Inc.

510 Market St.

San Diego, CA 92101

619-243-7500

The telephone company can ask you to disconnect the equipment

from the network until the problem is corrected or until you are sure

that the equipment is not malfunctioning.

The Model 1001 interface connects to the Public Switched Telephone

Network through a FCC registered NCTE which specifies the type of

network jack to be used.

Disruption of the Network

If the Model 1001 disrupts the telephone network, the telephone

company can discontinue your service temporarily. If possible, the

telephone company will notify you in advance. If advance notice is not

practical, they will notify you as soon as possible. You are also

informed of your right to file a complaint with the FCC.

Telephone Company Facility Changes

The telephone company can make changes in its facilities, equipment,

operations, or procedures that can affect the operation of your

equipment. If they do, you should be notified in advance so you have

an opportunity to maintain uninterrupted telephone service.

FCC RADIO FREQUENCY EXPOSURE INFORMATION

In August 1996, the Federal Communication Commission (FCC) of the

United States, with its action in Report and Order FCC 96-326,

adopted an updated safety standard for human exposure to radio

frequency (RF) electromagnetic energy emitted by FCC regulated

transmitters. Those guidelines are consistent with the safety standard

previously set by both U.S. and international standards bodies. The

design of this device complies with the FCC guidelines and these

international standards.

Use only the supplied antenna. Unauthorized antennas, damaged

antennas, modifications, or attachments could impair call quality,

damage the device, or result in violation of FCC regulations. Please

contact CardioNet if damage to the unit is apparent.

BODY-WORN OPERATION

This device was tested with the softcase sup-

plied by CardioNet as an accessory to this

device and was found to comply with the

FCC exposure requirements.

When operating this device, a minimum separation distance of 1.5 cm

must be maintained between the users body and the monitor,

including its antenna, to comply with the FCC exposure limits.

To maintain compliance with FCC RF exposure requirement, use only

carrying accessories that maintain a 1.5 cm separation distance

between the user’s body and the device, including the antenna. These

carrying accessories should not contain

metallic components in its assembly. The use of carrying accessories

that do not satisfy these requirements may not comply with FCC RF

exposure requirements, and should be avoided.

This particular device has not been designed for held-to-ear use and

should never be used against the ear.

For more information about RF exposure, please visit the FCC website

at www.fcc.gov .

Cardionet 1006 Monitor User Manual PIM revB

Cardionet Monitor PIM revB

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