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 1 Overview Description Indications for Use Contraindications for Use 2 2 3 4 Precautions 5 Features Operation Features Physical Features 6 6 7 Preparing the CardioNet System Configuring the Monitor - Patient Profile Downloading the Monitor - Patient Profile to the Monitor 8 8 8 Preparing the Patient Electrode Application CardioNet Electrode and Lead Placement Educate the Patient 9 9 10 11 Instruct the Patient Review of Features Entering Sympto
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.
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.
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 fi
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 (>
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.
Features Operation Features CardioNet Sensor with leads 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.
Physical Features During monitoring, the CardioNet System has features to ensure ease of use and patient compliance. several 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.
Preparing the CardioNet System 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.
Preparing the Patient 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.
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.
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.
Instruct the Patient 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.
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.
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.
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 Cell Signal Strength The battery power screen provides more in-depth information on the time remaining for the Sensor and the Monitor batteries. The cell signal strength screen provides more in-depth information on how strong the cellular signal at the Monitor’s location.
Installing the Base 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.
Service and Maintenance 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.
Troubleshooting Problem Recommended Solution Low Battery on Sensor Install new battery. Inspect battery compartment, clean contacts if necessary. Low Battery on Return Monitor to Base for recharging. Monitor Ensure battery is being recharged for at least 4 hours per day. No splash screen when Return Monitor to Base for recharging. Monitor is turned on. Battery does not last 18 hours No Display on Monitor Monitor displays electrode placement warning.
Specifications Dimensions Sensor Dimensions 4.1 x 0.7 Weight: 2.1 oz Sensor neck strap 12 x 24 x 0.2 Monitor 5.9 x 3.3 x 1.0 Weight: 11.0 oz Base 4.0 x 4.0 x 3.6 Weight: 6.1 oz LCD 3.0 x 2.3, touch screen, monochrome, EL backlight Functional Channels Resolution Recording Sample Rate Frequency Response Battery Life 2 12 Bit Full Disclosure 250 Samples / sec 0.5 hZ - 40 Hz Monitor: (18 hr) rechargable Sensor: (24 hr) AAA Alkaline Base Connectors Power in (12V 1.
Equipment symbols Symbol Description Consult Manual Year of Manufacture 2000 Type B Equipment SN Serial Number Hardware Requirements In Home Requirements Touch tone telephone AC powered outlet PC Requirements Serial port installed 20 CardioNet AECG System
Section II Physician Instructions Section II is for physicians who will be prescribing patients for the CardioNet Monitoring Service.
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.
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.
Disclosure of Technical Performance Specification 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).
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.
