Cardionet 1011 Ambulatory Cardiac Outpatient Telemetry User Manual C5 PIM 220008301revA

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PHYSICIAN’S
INSERVICE
MANUAL
Model CN1006
(C5)
CONTACT INFORMATION
CardioNet Monitoring Center
Tel. 866-727-3397
•
For all clinical issues
•
To extend or discontinue monitoring service
•
For “fetch requests” for additional ECG data
Main Business Number
Tel. 866-426-4404
•
For non-clinical issues
Physician Relations Hotline
Tel. 800-242-3980
•
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
Page 2 of 17
CONTENTS
CARDIONET: MOBILE CARDIAC OUTPATIENT TELEMETRY
TECHNOLOGY OVERVIEW
SERVICE OVERVIEW
PHYSICIAN REPORTS
PRESCRIBING CARDIONET
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTOR
FOR USE ON ALL PATIENTS
TECHNICAL SPECIFICATIONS
10
TECHNICAL SPECIFICATIONS
11
IN-HOME REQUIREMENTS
12
FCC COMPLIANCE
13
ARRHYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS
13
HEART RATE MEASUREMENT REPORT
13
FCC RULES PART 68
13
REN
14
SERVICE
14
DISRUPTION OF THE NETWORK
14
FCC RADIO FREQUENCY EXPOSURE INFORMATION
14
BODY-WORN OPERATION
15
PACEMAKER DETECTION RESULTS
15
FCC COMPLIANCE
15
FCC RULES PART 15
15
PRECAUTIONS
15
CAUTIONS AND WARNINGS
16
Page 3 of 17
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.
Page 4 of 17
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.
Page 5 of 17
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.
Page 6 of 17
PHYSICIAN REPORTS
Three types of reports may be issued to physicians during monitoring:
•
Daily Telemetry Reports: sent every 24 hours for all patients, which contains sample strips
of arrhythmias detected and patient-reported symptoms, heart rate and AF frequency and
duration data.
•
Urgent Reports: issued when an event occurs that the physician has defined as urgent.
•
Summary Reports: Provides a summary of all billable days of service.
Physician reports are available by fax or through PEMS, CardioNet’s Internet-based patient
management system. For information or in-service on PEMS, please contact your CardioNet
Account Representative.
The CardioNet Monitoring Center is staffed with highly qualified and experienced cardiac
monitoring specialists. At a minimum, all monitoring specialists are CCT certified. They have
experience in cardiovascular monitoring, hospital based C.C.U. and I.C.U. telemetry, and/ or
emergency medical services.
As a Medicare provider, CardioNet is licensed as an Independent Diagnostic Testing Facility
(IDTF).
The CardioNet monitoring specialists serve a vital role in continuously analyzing and
responding to arrhythmic events. The monitoring specialists provide a thorough preliminary
analysis of the patient’s ECG to insure that the initial interpretation is accurate and presented in
the appropriate time and manner as requested by the physician.
Calls may be monitored and recorded for quality assurance. CardioNet requires that all
monitoring specialists participate in additional training and educational programs. A
continuous QA process with independent oversight has been established for all facets of the
service center operation.
The monitoring specialists, based on defined physician guidelines, prepare Daily Telemetry
Reports for final physician review and interpretation.
The CardioNet Monitoring Center continuously analyzes events, responds appropriately, and
issues telemetry reports 24/7/365.
Page 7 of 17
PRESCRIBING CARDIONET
Prescribing CardioNet monitoring for a patient is easy, once your practice has been enrolled in
our service. Simply fill out a CardioNet Patient Prescription/Order Form, (provided to your
practice when it was enrolled) sign it and fax it to the number listed on the top of the form. Also
fax one of the following:
•
A copy of the front and back of the patient’s insurance cards or
•
The CardioNet Patient Enrollment form or
•
The patient’s fact sheet
The practice will receive a faxed confirmation that the referral has been received.
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA
DETECTOR
Indications for Use:
The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for:
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 fibrillation, atrial flutter, 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; 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 outpatient monitoring of antiarrhythmic therapy: a) Monitoring of
therapeutic and potential proarrhythmic effects of membrane active drugs, b) Monitoring
of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial
fibrillation).
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 fibrillation or atrial flutter.
8. Patients requiring measurement, analysis and reporting of QT interval, excluding
patients with a documented history of sustained atrial fibrillation or atrial flutter.
9. Patients who require monitoring for potential arrhythmias based on risk factors (e.g.
atrial fibrillation).
Page 8 of 17
10. Patients requiring measurement of ST segment changes. The device is not intended to
sound any alarms for ST segment changes.
11. The device is intended to identify Cyclic Variation of Heart Rate (CVHR) pattern to
evaluate need of further testing for sleep disorders
FOR USE ON ALL PATIENTS
The CardioNet MCOT system is intended for use on adults, children and infants weighing less
than 22 pounds.
Contraindications for use:
1. Patients with potentially life-threatening arrhythmias who require inpatient Monitoring.
2. Patients who the attending physician recommends should be hospitalized for ECG
monitoring.
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.
Page 9 of 17
TECHNICAL SPECIFICATIONS
The technical specifications are subject to change.
PHYSICAL
Sensor
3 inches x 1.9 inches x 0.7 inch; Weight: 3.0 oz. with battery
Monitor
4.7 inches x 2.6 inches x 0.9 inch; Weight: 6 oz.
LCD
2.27 inches x 1.7 inches; Touch screen: color
Base
4.3 inches x 3.7 inches x 1.0 inches; Weight: 6.0 oz.
FUNCTIONAL
Sample Rate
250 samples per second
Resolution
12 bits
Dynamic range
+/- 5 mV
Bandwidth
0.1 to 40 Hz
Channels
Battery Life: Monitor
Minimum 10 hrs (with cleared memory & fully recharged battery)
Battery Life: Sensor
24 hrs (1 AAA Alkaline)
Leakage Current
Less than .1 µ A Electrodes
TRANSMISSION
Sensor to Monitor
900 MHz ISM band RF transmission, digital error corrected. 150 foot range.
Retransmission if data is corrupted.
Monitor to Center
CDMA (PCS and cellular) wireless, digital error corrected. Telephone line
modem, digital error corrected. CDMA (PCS & cellular) wireless, digital error
corrected. Telephone line modem, digital error corrected. 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 is received at Monitoring Center within minutes with good
wireless coverage and/or modem communications.
OPERATING CONDITIONS
Operating Temperature
Sensor: 20 - 45°C; Monitor ; 0 - 45°C
Operating Humidity
10% - 95% non-condensing
Storage Temperature
-20 - 65°C non-condensing
Storage Humidity
5% - 95% non-condensing
Operation Altitude
700 - 1060 millibars
Page 10 of 17
TECHNICAL SPECIFICATIONS
CONNECTIONS
Base
Power in (15V, 1.2A max); Phone in (RJ-11); Phone out (RJ-11)
Monitor
Power in (15V, 1.2A max)
Wall Adaptor
Power in (100-240 VAC); Power out (15V, 1A or 15V, 1.67A)
STANDARDS COMPLIANCE
Monitor
EN60601-1; AAMI EC-38; FCC Part 15
Sensor
EN60601-1; AAMI EC-38; FCC Part 15
Base
EN60950; FCC Part 15, 68
AECG Equipment
Type I
Note: This equipment has been tested and found to comply with the limits for medical devices to the
IEC 60601-1-2:2001, 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
EQUIPMENT SYMBOLS
Page 11 of 17
IN-HOME REQUIREMENTS
1.
Touch tone, pulse telephone or cellular/PCS wireless coverage suitable for data
transmission
2.
AC powered outlet
Page 12 of 17
FCC COMPLIANCE
FCC ID
Sensor ISM
QBI-1011
Monitor ISM
Monitor Cell Modem
QBI-1012
RI7CC864-DVAL
Base
QBI-1013
ARRHYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS
The CardioNet C5 System incorporates an arrhythmia analysis algorithm whose performance
is presented below:
The algorithm results were obtained from the respective databases in strict accordance with EC57 and with 0% downtime on both databases.
Performance Measure
MIT Arrhythmia Database
Average QRS Detection
Sensitivity %
99.96
AHA Database
99.74
Average QRS Detection
Positive Predictivity %
99.83
99.83
The CardioNet C5 system does perform analysis of ST Segment changes. The ST Segment
analysis is done on all leads without any signal scaling or gain adjustment. There are no
operator selectable detection criteria for ST segment shifts.
The ST algorithm has been tested for accuracy of the ST segment data. The significance of the
ST segment changes need to be determined by a physician.
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
1.23%, 1.08%, and 15.84% respectively for the C5 product (model CN1006).
Sustained heart rate (SHR) is inversely proportional to the RR interval averaged over 10
seconds or 12 consecutive beats, whichever is shorter. The Heart Rate Trend Graph shows
SHR and its minimum and maximum values during that interval.
FCC RULES PART 68
FCC Part 68 Registration
The Model CN1006 complies with FCC Rules, Part 68. On this equipment is a label that
Page 13 of 17
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 CN1006 is 0.0B. 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.
1010 Second Avenue, Suite 700
San Diego, CA 92101
619-243-7500
The Model CN1006 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 CN1006 disrupts the telephone network, the telephone company can discontinue
the service temporarily.
Telephone Company Facility Changes
The telephone company can make changes in its facilities, equipment, operations, or
procedures that can affect the operation of equipment.
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,
Page 14 of 17
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 and was found to comply with the FCC exposure requirements. The
device was also tested and passed SAR (Specific Absorption Rate) testing.
For more information about RF exposure, please visit the FCC website at www.fcc.gov.
PACEMAKER DETECTION RESULTS
Pacemaker detection: Meets AAMI EC38
FCC 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 CN1006 has been tested and complies with the limits for a class B 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.
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.
Avoid Electromagnetic Interference
For the best recording results, 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
Page 15 of 17
service.
Use of CardioNet system with implanted pacemakers and ICDs (defibrillators)
If the patient has an implanted pacemaker or defibrillator (ICD), the manufacturer may have
recommended certain precautions when using a cellular phone. Since the CardioNet monitor
contains a cellular phone, the patient 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 defi brillator.
•
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
•
Refer to the manufacturer’s information for guidance regarding your pacemaker or ICD and
possible interference issues.
CAUTIONS AND WARNINGS
Caution: Power Down Monitor 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.
Caution:
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.
Page 16 of 17
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. Refer to the
Patient Education Guide for complete instruction on skin preparation, electrode placement,
and removal.
Warning: Do Not Tamper
There are no serviceable parts in the CardioNet System. Removing the cover of any of
component may alter performance.
Warning: Not an Emergency Response Service
CardioNet is not an emergency response service. If a patient experiences symptoms that
concern the patient, they should seek medical help.
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 80°C (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.
Page 17 of 17

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