Cardionet 1002 User 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
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
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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
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.
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CardioNet AECG System
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
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CardioNet AECG System
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
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CardioNet AECG System
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
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CardioNet AECG System
Precautions
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.
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.
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CardioNet AECG System
Features
Operation Features
CardioNet
CardioNet Sensor without leads
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.
Sensor with leads
CardioNet Monitor
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CardioNet AECG System
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.
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CardioNet AECG System
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