Cardionet 1002 User Manual CN Physicians Guide 2001
Cardionet CN Physicians Guide 2001
manual
CardioNet Ambulatory ECG System
and Arrhythmia Detector
Document Number - 100008
Revision E
Model Number 1001
Physician’s
Operation Manual
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A PHYSICIAN
Table of Contents
CardioNet AECG System
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Section I - Clinician Instructions
Overview
Description
Indications for Use
Contraindications for Use
Precautions
Features
Operation Features
Physical Features
Preparing the CardioNet System
Configuring the Monitor - Patient Profile
Downloading the Monitor - Patient Profile to the Monitor
Preparing the Patient
Electrode Application
CardioNet Electrode and Lead Placement
Educate the Patient
Instruct the Patient
Review of Features
Entering Symptoms and Activities
Changing Monitor Options
Viewing Monitor Status
Installing the Base
Recharging the Monitor
Downloading ECG
Service and Maintenance
Troubleshooting
Specifications
Equipment Symbols
Section II - Physician Instructions
Automatic Download Preferences
Arrhythmia Detection Preferences
Disclosure of Technical Performance Specification
Disclosure of Technical Performance Specification (con’t)
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CardioNet AECG System
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Section I
Clinician
Instructions
Section I is for clinicians such as nurses and / or technicians
who will be the providing the education and instruction for
patients starting on the CardioNet Service.
Included in this section are instructions for preparing and
educating the patient for successful CardioNet Monitoring.
Also included in this section are instructions, tools, and
helpful hints to guide clinicians through maintenance and
configuration of the CardioNet Monitor.
CardioNet AECG System
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Overview
Description
The CardioNet Monitoring System 1001 is a battery operated,
ambulatory arrhythmia detector designed for continuous 24 hour, 7 day
per week ECG monitoring. The CardioNet Monitoring System consists of
three components; a Sensor, a Monitor and a Base. The CardioNet
System provides a practical and convenient method for collecting
diagnostic ECGs over an extended period of time.
The CardioNet Monitoring System has the capability to record, store and
transmit ECG and event data. The ECG and event data is continuously
recorded in digital flash memory within the device. The System contains
an on board algorithm, which performs of real time ECG analysis and
arrhythmia detection. When an event occurs, whether it is symptomatic
or asymptomatic, the Monitor automatically sends the ECG data to the
CardioNet Monitoring Center either via the built in cellular phone or the
land line telephone connection of the base.
The multi-lead design provides enhanced ECG waveform definition and
enables a more effective identification of artifact. With a sampling rate of
250 measurements per second and 12 bit A to D, the device produces the
necessary amplitude and resolution to detect very fast QRS complexes
seen in some atrial arrhythmias.
The LCD display with touch panel enables all users to easily control a
variety of functions, so that operation of the device is tailored to the needs
of the physician, the patient and the clinician.
The CardioNet System: Monitor, Sensor and Base
CardioNet AECG System
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Indications for Use
The CardioNet system is for use on low risk arrhythmia patients and
specific indications for use are as follows:
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 lightheadedness
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
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, possibility secondary to atrial fibrillation
10) Data from the device may be used by another device to analyze,
measure or report QT interval. This device does not sound any alarms for
QT interval changes
CardioNet AECG System
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Contraindications for Use
The CardioNet system is for use on low risk arrhythmia patients and
is contraindicated for use on the following patients:
1) Patients who have a history of sustained ventricular tachycardia or a
documented occurrence of ventricular fibrillation
2) Patients the attending physician thinks will be at risk for ventricular
tachycardia or ventricular fibrillation as indicated by the following:
-A measured ejection fraction (EF) 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 a recent heart
valve surgery
3) Patients who the attending physician thinks should be hospitalized
Precautions
CardioNet AECG System
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Warnings and Cautions
Caution: Power Down and Remove Before Showering
While the CardioNet Sensor and Monitor are water resistant, they are
not water proof. Patients must be instructed to turn the Monitor off
and remove both the Sensor and Monitor before showering or
swimming. Refer to page 11 for instruction on removal and
reapplication.
Warning: For Adult Use Only
The CardioNet Monitoring System is intended for Adult use only. It
shall not be used on infants weighing less then 22 lbs.
Warning: 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: The CardioNet Monitor is not to be used as an apnea
monitor.
Warning: Do not use any telephone other than the phone that is
connected to the CardioNet Base while the patient is being
monitored. If dialing tones are heard in a remote telephone, hang up
immediately to allow the CardioNet Monitor to dial the Monitoring
Center.
Warning: There are no serviceable parts in the CardioNet System.
Removing the cover of any of component (other than the battery
compartment) may alter performance.
Patient leads must be removed before external defibrillation.
Observe all local laws for the disposal of alkaline
batteries.
Do not leave the battery in the Sensor when it is not in use.
Damage from corrosion could result.
For the best recording results, the patient should be instructed
to avoid close proximity to heavy equipment or other sources of
electromagnetic interference such as electric blankets, heating
pads, etc.
Features
CardioNet AECG System
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Operation Features
The CardioNet Monitor has two separate components: the Sensor
and the Monitor. The Sensor is worn by the patient and acquires
ECG data from the electrodes. The Monitor can be worn by the
patient or can be located up to 30 feet away. The Monitor receives
the ECG data from the Sensor and performs real time arrhythmia
analysis. When an event occurs, (either symptomatic or
asymptomatic) the Monitor attempts to call the CardioNet
Monitoring Center via either the cell phone or telephone land line
and to transmit the event for review by trained CardioNet
personnel.
CardioNet Sensor without leads CardioNet
Sensor with leads
CardioNet Monitor
CardioNet AECG System
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Physical Features
During monitoring, the CardioNet System has several
features to ensure ease of use and patient compliance.
LED Indicator: Blinks green to indicate Monitor is actively
analyzing ECG data. Blinks red to indicate Monitor is not collecting
and analyzing ECG data.
Ear Speaker: Voice communications will be heard through the ear
speaker when the Monitor is not in the Base.
Touch Screen: Interactive touch screen menus allow patients to
enter symptoms, record activities, adjust Monitor
settings and view Monitor status.
Speaker phone: Voice communications will be heard through the
speaker phone when the Monitor is in the Base.
On / Off / Wake: Turns the Monitor on or off and wakes from
standby mode.
Preparing the CardioNet System
CardioNet AECG System
8
Configure Monitor - Patient Profile
The Monitor-Patient profile consists of information specific to the
patient. Each profile is determined by the physician prior to
monitor placement as part of the monitoring prescription. A
Monitor-Patient profile will contain information regarding Monitor
screen preferences, automatic download time preferences and
automatic threshold levels. Physicians can customize a Monitor
Patient profile for a patient or can chose the default settings.
Please refer to the physician’s prescription prior to choosing your
patient’s Profile settings.
Download Monitor - Patient Profile to Monitor
Choose any Cardionet System for placement on a patient. Place
the Monitor into a Base connected to the computer that has been
designated as a the CardioNet Utility PC. Open the software
application on the computer’s desktop listed as “CardioNet”. Once
the Monitor is placed in the Base, the CardioNet software will
supply a list of your physician’s patients waiting to receive a
CardioNet Monitoring System. The Software will prompt the
clinician to select the patient who will be receiving the System.
After the patient selection has been made, the default Monitor -
Patient Profile will be displayed. Any changes to the Profile as
indicated by the physician on the prescription can be made at this
time (physicians refer Physician Instructions, pg III). Once all
choices have been indicated, the software will display a
confirmation notification indicating the Monitor is ready for
placement on the selected patient.
Preparing the Patient
CardioNet AECG System
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Electrode Application
With CardioNet’s on board analysis of ECG, proper electrode and
lead placement is imperative to achieve good results. The diagram
on the following page demonstrates CardioNet’s recommended
placement for the electrodes, the leads and the Sensor. However,
optimum electrode placement may vary slightly according to
patient body shape and size. Verify good quality baseline ECG
signals after placing electrodes.
Use only electrodes supplied by CardioNet or ones designed for
longer term monitoring. Proper preparation of the patient’s skin is
absolutely essential for obtaining a quality ECG recording. Refer
to your electrode provider for instructions on proper skin
preparation.
Correct application of the electrodes, demonstrated on the
following pages, is imperative for proper ECG analysis. Please
refer to the diagram for accurate placement.
CardioNet AECG System
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CardioNet Electrode and Lead Placement
CH 1 -
CH 1 +
CH 2 -
CH 2 +
CH 3 -
CH 3 +
White lead: Center of the right clavicle
Black lead: Center of the left clavicle
Red lead: Left anterior axillary line, in the
7th to 8th intercostal space.
*Optimum electrode placement may vary slightly according to
patient body shape and size. Verify good quality baseline ECG
signals after placing electrodes.
* Tape may be used to secure the lead wires in the event of
excess signal noise on the ECG.
11
Educate the patient
Explain the preparation and the position for proper electrode placement.
Explain that if any electrode loses contact or dries out during the
monitoring process it must be replaced immediately. Additionally, the
CardioNet Monitor will recognize when leads are disconnected or worn
out and will alert the patient.
Explain that new electrodes should be examined prior to application.
Electrodes with dried gel should not be used.
Show the patient how to install a fresh AA battery into the Sensor.
Explain reattachment of the Sensor lead set to the electrodes. Show the
patient how to connect the lead set and secure the lead wires.
Explain that the Sensor and the Monitor MAY NOT be worn during
showering or swimming. The adhesive electrodes ONLY may be worn in
the shower, but they should not get soaked. The skin around the
electrodes should be gently washed and the electrodes repressed to the
skin after drying.
Power down and remove before showering:
1) Press the On / Off / Wake button located on the front of the Monitor.
2) Touch the Options button on the LCD screen.
3) Touch the Monitor Power button on the LCD screen.
4) Touch the Off button on the LCD screen.
5) At the prompt for confirmation of you choice, press OK on the LCD
screen to turn power off.
6) Wait for the Monitor to completely power down. The LCD screen will
indicate the Monitor is turning off and then become blank.
7) Remove the battery from the Sensor
8) Remove the Sensor leads from the electrodes. The patient may
choose to wear the electrodes during a shower or remove the electrodes
and apply a new set before reattaching the Sensor.
After Showering:
1) Re-press electrodes worn during showering or apply new electrodes.
2) Reattach the Sensor to the electrodes and replace Sensor battery.
3) Turn the Monitor on to resume monitoring by pushing the On/ Off/
Wake button located on the front of the Monitor.
Instruct the Patient
CardioNet AECG System
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Instructing the patient on the operations and functions of the
CardioNet Monitoring System is a key component of successful
monitoring. The following includes instructions for interaction with
the CardioNet Monitor, including entering symptoms and activities,
changing Monitor options, and viewing Monitor status.
Review of features
LED Indicator: Blinks green to indicate Monitor is actively
analyzing ECG data. Blinks red to indicate Monitor is not collecting
and analyzing ECG data.
Ear Speaker: Voice communications will be heard through the ear
speaker when the Monitor is not in the Base.
Touch Screen: Interactive touch screen menus allow patients to
enter symptoms, record activities, adjust Monitor
settings and view Monitor status.
Speaker phone: Voice communications will be heard through the
speaker phone when the Monitor is in the Base.
On / Off / Wake: Turns the Monitor on or off and wakes from
standby mode.
CardioNet AECG System
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Entering Symptoms and Activities
Main Menu
When the patient touches the Record
Symptoms area on the screen with their
fingertip, the Symptoms Menu will appear
and the patient will be prompted to make a
selection.
Symptoms Menu
Patients have four choices to select for
symptoms on the Symptoms Menu. One or
more symptoms can be selected.
The < Back selection will return the patient
to the Main Menu
The Next > selection will advance the
patient to the Activity Menu
Activity Menu
Patients have four choices to select for
symptoms on the Symptoms Menu. Only
one activity can be selected from the
Activity Menu.
The < Back selection will return the patient
to the Symptoms Menu
The Done > selection will return the patient
to the Main Menu
CardioNet AECG System
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Changing Monitor Options
Main Menu
When the patient touches the options area
on the screen with their fingertip, the
Options Menu will appear and the patient
will be prompted to make a selection.
Volume
The Volume option allows the patient three
audible tones: high, medium, and low and
a vibrate option.
Contrast
The Contrast option allows the patient to
adjust the contrast of the screen to high,
medium or low when better viewing is
necessary.
Cellular Power
The Cellular Power option allows the
patient to turn the cell phone in the Monitor
off or on. When the cell phone is off, the
Monitor is still recording, but no automatic
transmissions can be made to the
CardioNet Monitoring Center unless the
Monitor is placed in the base.
Monitor Power
The Monitor Power option allows the
patient to turn the monitor off. This is
recommended any time the patient wants
to shower, swim or change electrodes.The
Monitor will not record ECG data when the
power is off.
CardioNet AECG System
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Viewing Monitor Status
Main Menu
When the patient touches the icons area on
the screen with their fingertip, the screen
will provide more in-depth information on
battery power or cell signal strength.
Battery Power
The battery power screen
provides more in-depth
information on the time
remaining for the Sensor
and the Monitor batteries.
Cell Signal Strength
The cell signal strength
screen provides more
in-depth information on
how strong the cellular
signal at the Monitor’s
location.
CardioNet AECG System
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Installing the Base
Recharging the Monitor
The CardioNet Monitor contains a rechargeable battery which can
be replenished in the Base. This battery requires a charge of 4
hours for each 18 hours of use. When in the Base, the LCD on the
Monitor will indicate the battery charge status. To fully charge,
leave the Monitor in the Base for four hours. Touching the battery
icon on the screen will indicate how much battery life is remaining
on the Monitor.
Patients will need to be instructed how to install the Base when
they return home. Installing the Base properly ensures that the
Monitor battery will properly recharge and that the ECG data can
be sent while the Monitor is in the Base. Patients will need to
unplug their existing telephone line from the wall. The telephone
cable (already attached to the patients telephone) then inserts into
the “Phone In” port of the Base. The additional provided telephone
cable then inserts to the Base “Line In” port, then into the tele-
phone jack in the wall.
CardioNet Base
Downloading ECG
The CardioNet Monitor is configured to download ECG data
automatically at specified times as designated by a physician.
Automatic transmission times will be configured during the initial
patient set up, the default is once per 24 hours. Data can also be
downloaded manually by patient activation of the call button.
Detailed instructions should be provided by the physician to
determine when patients should use the call button.
Service and Maintenance
CardioNet AECG System
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Cleaning
Dampen a soft cloth with disinfecting solution. Wipe the
external surfaces of the Sensor, Monitor and Base. Do not
spray or submerge any component with liquid or foam. Each
component should be wiped with a soft damp cloth after
cleaning to ensure no fluid has pooled on external surfaces.
Service
If you experience additional problems with any components of
the CardioNet Monitoring System, review the problems and
solutions listed in the trouble shooting section. If additional
assistance is required contact customer support via telephone
or fax listed below.
Telephone: 619.243.7500
Fax: 619.243.7700
Call customer support before returning a CardioNet Monitoring
System to make shipping arrangements.
Troubleshooting
CardioNet AECG System
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Problem Recommended Solution
No Display on Monitor
Low Battery on Sensor
Battery does not last
18 hours
No splash screen when
Monitor is turned on.
No connection when
call button is pressed
Ensure Monitor is turned ON.
Return Monitor to Base for
recharging.
Inspect battery compartment,
clean contacts if necessary.
Return Monitor to Base for
recharging.
Ensure battery is being
recharged for at least 4 hours
per day.
Return Monitor to Base for
recharging.
Ensure Monitor is in cellular
range.
Ensure Monitor is turned ON.
Check electrode placement
and connections.
Install new battery.
Place Monitor in base.
Low Battery on
Monitor
Monitor displays
electrode placement
warning.
Specifications
CardioNet AECG System
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Dimensions
Sensor Dimensions
4.1 x 0.7
Weight: 2.1 oz
Monitor
5.9 x 3.3 x 1.0
Weight: 11.0 oz
LCD
3.0 x 2.3, touch screen, monochrome, EL backlight
Functional
Channels
Resolution
Recording
Sample Rate
Frequency Response
Battery Life
Base Connectors
Power in (12V 1.2A)
Phone in (RJ11)
Phone out (RJ11)
Serial RS232
Operating conditions
Sensor
Immersion resistant (IPx-0)
Operating temperature 20 - 45 C
Storage temperature -20 - 65 C
Relative humidity 10% - 95%, noncondensing
Monitor and Base
Splash resistant (IPx-0)
Operating temperature 0 - 45 C
Storage temperature -20 - 65 C
Relative humidity 10% - 95%, noncondensing
2
12 Bit
Full Disclosure
250 Samples / sec
0.5 hZ - 40 Hz
Monitor: (18 hr) rechargable
Sensor: (24 hr) AAA Alkaline
Sensor neck strap
12 x 24 x 0.2
Base
4.0 x 4.0 x 3.6
Weight: 6.1 oz
Equipment symbols
CardioNet AECG System
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Symbol Description
Consult Manual
Year of Manufacture
Type B Equipment
Serial Number
SN
Hardware Requirements
In Home Requirements
Touch tone telephone
AC powered outlet
PC Requirements
Serial port installed
2000
CardioNet AECG System
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Section II
Physician
Instructions
Section II is for physicians who will be prescribing
patients for the CardioNet Monitoring Service.
Detailed instructions covered in this section:
- Monitor Screen Preferences
- Automatic Download Preferences
- Arrhythmia Detection Preferences
- Disclosure of Technical Specifications
CardioNet AECG System
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Automatic Download Preferences
When manual measurements of the ECG by CardioNet’s trained
personnel are required, the physician can indicate preferences for
automatic transmission of ECG data in the physician’s prescription.
This is recommended for patients requiring measurements of the
PR interval, the QRS complex, or the QT interval.
Options will be listed on the prescription as follows:
QD (Once per 24 hours)
BID (Two times per 24 hours / every 12 hours)
TID (Three times per 24 hours / every 8 hours)
QID (Four times per 24 hours / every 6 hours)
Q4 (Six times per 24 hours / every 4 hours)
The default for automatic download of ECG without a cardiac event
is one time per 24 hours. The physician will receive a strip of ECG
data reviewed by CardioNet personnel that will include all
measurements indicated by the physician on the prescription.
The following options can be listed on the prescription as follows:
PR interval
QRS complex
QT interval
One or multiple selections can be made.
CardioNet AECG System
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Arrhythmia Detection Preferences
The CardioNet System is for use on low risk patients with the following
contraindications:
1) Patients who have a history of sustained ventricular tachycardia or a
documented occurrence of ventricular fibrillation.
2) Patients the attending physician thinks will be at risk for ventricular tachycardia
or ventricular fibrillation as indicated by the following:
-A measured ejection fraction (EF) 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 a recent heart valve surgery.
3) Patients who the attending physician thinks should be hospitalized.
CardioNet’s on board algorithm continually analyzes ECG for potential
arrhythmias on the following list. Any arrhythmia may be omitted from the list on
the prescription by the prescribing physician. The optional item - Pacer spike
detection - will not be routinely detected unless indicated by the physician.
Arrhythmias will be listed on the prescription as follows:
CardioNet Event Threshold Table
Arrhythmia Value
Bradycardia <40 BPM & sustained > 60 sec
Tachycardia >150 BPM & sustained > 60 sec
Irregular Rhythm to Detect Irregular HR (IRR >25) > 60 sec
Atrial Fibrillation / Flutter
PVC’s >8 occurrences in one minute
Ventricular Bigeminy >6 occurrences in one minute
Ventricular Trigeminy >6 occurrences in one minute
Ventricular Tachycardia >100 BPM & sustained >4 beats
Ventricular Fibrillation Onset
Pause >2 seconds
Long Pause >3 seconds
*Irregular R to R is defined as: Standard deviation x 100 [0.01 sec]
RR mean
Disclosure of Technical Performance Specification
CardioNet AECG System
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1) Analysis of heart rate
The average heart rate is calculated on the basis of the mean R to
R interval in the last 6 seconds or 8 R to R intervals (whatever is
shorter). For the MIT-BIH ECG database, the average RMS error
for the calculated HR was 1.07%, and for the AHA ECG database,
the RMS error for the HR calculated was 2.08% (see table below).
2) Analysis of rhythm Disturbances
The CardioNet System detects the arrhythmias and other ECG
abnormalities shown in the CardioNet Event Thresholds Table.
These include the following:
- Bradycardia
- Tachycardia
- Irregular heart rate to detect possible Atrial Fibrillation /
Flutter
- Frequent PVCs
- Ventricular Tachycardia
- Ventricular Fibrillation
- Pauses
AHA ECG Database HR measurements
Record ErrSum RefSum Nmeas MeanRefHR RMSerror(%)
___________________________________________________________________
Sum 130111.6913 2167402.8283 26706
Gross 81.1579 2.7197
Average 81.4511 2.0762
Summary of results from 78 records
MIT-BIH ECG Database HR measurements
Record ErrSum RefSum Nmeas MeanRefHR RMSerror(%)
________________________________________________________________________
Sum 25694.4788 1016331.6122 13030
Gross 77.9994 1.8003
Average 78.0769 1.0691
Summary of results from 44 records
CardioNet AECG System
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Disclosure of Technical Performance Specification (con’t)
3) Analysis of ST alteration
The CardioNet System does not currently address ST analysis.
4) Recognition and measurement of the QRS morphology and
duration
QRS morphology classification (such as labeling of each detected
beat as normal or ventricular, etc.) is provided by the Mortara
Arrhythmia Analysis Library, as part of the ECG analysis. The
CardioNet System does not report measurements of the QRS
duration.
5) Learning Phase
A learning phase occurs for one minute during the initial analysis
of the patient’s baseline ECG. A learning phase also occurs for one
minute each time the Monitor is powered up and after a leads off
detection has been detected and reset.
6) Measurement of PR intervals
The CardioNet System does not provide measurements of PR
intervals.
7) Recognition of paced rhythms
The CardioNet supports recognition of pacer pulses. The
CardioNet System detects pacer pulses and calculates
pacemaker non-fire, non-capture rates.