Cardionet 1006 Monitor User Manual PIM revB

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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
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
Caution: Federal law restricts this device
to sale by or on the order of a physician.
Copyright 2004
All rights reserved
Lit Number - 100327
Revision E
February 2004
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.
Patient Monitored
24/7/365
Patient Enters Symptoms
and Activities
Physician Receives
CardioNet Report
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
powered by a disposable alkaline battery, which typically lasts 24-36
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
CardioNet Monitor in Base
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.
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 preauthorization/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.
CardioNet provides a
wealth of educational
tools, including the
Patient Education Guide,
the Patient Pocket Guide,
and a video.
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.
Monitoring Specialists Review
and Interpret Data to Ensure
Accuracy
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.
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.
Please enter your username and password to log in.
Username
Password
Login
Log in to access the
CardioNet Patient
Enrollment and
Management System.
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.
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
to 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
10
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.
11
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.
An 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.
12
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.
13
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.
14
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 preauthorization/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.
15
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 nonMedicare 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.
16
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.
17
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.
18
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
Battery Life
Monitor: (12-16 hours average with cleared memory
and fully recharged battery), rechargeable Sensor:
(24 hr) AA Alkaline
Less than .1 µ V Electrodes
Leakage current
Transmission
Sensor to Monitor 900 MHz ISM band RF transmission, digital error corrected. 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.
19
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
Monitor
Power in (15V, 1.2A max)
Phone in (RJ-11)
Phone out (RJ-11)
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.
20
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.
21
EQUIPMENT SYMBOLS
Consult Manual
Year of Manufacture
2000
Type BF Equipment
SN
Serial Number
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
22
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
23
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)
MeanRefHR
RMSerror(%)
Gross
81.15792.7197
2.7197
Average
81.4511
2.0762
Sum
ErrSum
RefSu
Nmeas
130111.6913
2167402.8283
26706
MIT-BIH Arrhythmia Database (Summary of results from 44 records)
MeanRefHR
RMSerror(%)
Gross
77.9994
1.8003
Average
78.0769
1.0691
MeanRefHR
RMSerror(%)
Gross
74.4867
39.5198
Average
74.4867
30.8921
Sum
ErrSum
RefSu
Nmeas
25694.4788
1016331.6122
13030
NST Database (Summary of results from 12 records)
Sum
ErrSum
RefSu
Nmeas
3098725.4772
266364.2826
3576
24
RUN-BY-RUN REPORT
AHA ECG Database
Record
CTs CFN CTp CFP STs SFN STp SFP LTs
LFN LTp
Sum
904
53
95 1048 35
379
85 487
12
26
LFP CSe C+P SSe S+P LSe L+P
75
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
10
15
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
Sum
26 0
Gross
100 100
Average
100 100
DSe D+P
79
77
Ref duration Test duration
1:28:50.140 1:10:59.646
99
96
Summary of results from 78 records
MIT-BIH Detection
Record TPs FN TPp FP ESe E+P
Sum
1 0
Gross
100 100
Average
100 100
DSe D+P
91
92
Ref duration Test duration
1:37.900
1:44.032
86
86
Summary of results from 44 records
CU Detection
Record TPs FN TPp FP ESe E+P DSe D+P
Sum
26 5 28 2
Gross
84 93 53 86
Average
87 96 52 76
Ref duration Test duration
40:38.772
24:55.332
Summary of results from 30 records
PACEMAKER DETECTION RESULTS
Pacemaker detection:
Meets AAMI EC38
25
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.
26
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.
27
BODY-WORN OPERATION
This device was tested with the softcase supplied 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 .
28
SAMPLE FORMS AND REPORTS
Examples of the forms listed below follow.
Patient Enrollment Form
Physician Enrollment Form
Client Enrollment Form
Patient Prescription Form
Physician Notification Orders Form
Physician Notification Change Orders Form
Daily Mobile Report
Urgent Mobile Telemetry Report
End of Service Report
To access electronic versions of forms and reports, log on
to www.cardionet.com..
29

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