Cardionet 1002 User Manual CN Physicians Guide 2001
Cardionet CN Physicians Guide 2001
manual
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| Document ID | 239418 |
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| Document Description | manual |
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| Document Type | User Manual |
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| Filesize | 244.5kB (3056199 bits) |
| Date Submitted | 2002-04-26 00:00:00 |
| Date Available | 2002-08-20 00:00:00 |
| Creation Date | 2002-01-21 16:54:29 |
| Producing Software | Acrobat PDFWriter 4.05 for Windows NT |
| Document Lastmod | 0000-00-00 00:00:00 |
| Document Title | CN Physicians Guide 2001.PDF |
| Document Creator | QuarkXPress (tm) - [CN Physicians Guide 2001.qxd] |
| Document Author: | linda.cox |
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 10 11 Instruct the Patient Review of Features Entering Symptoms and Activities Changing Monitor Options Viewing Monitor Status Installing the Base Recharging the Monitor Downloading ECG 12 12 13 14 15 16 16 16 Service and Maintenance Troubleshooting Specifications Equipment Symbols 17 18 19 20 Section II - Physician Instructions 21 Automatic Download Preferences Arrhythmia Detection Preferences Disclosure of Technical Performance Specification Disclosure of Technical Performance Specification (con’t) 22 23 24 25 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. 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 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 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 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. CardioNet AECG System 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. 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 Monitor CardioNet AECG System 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. 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 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. 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. CardioNet AECG System 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. 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 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. 10 CardioNet AECG System 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. 11 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. 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. 12 CardioNet AECG System 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 13 CardioNet AECG System 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. 14 CardioNet AECG System 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. 15 CardioNet AECG System 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. The additional provided telephone cable then inserts to the Base “Line In” port, then into the telephone jack in the wall. CardioNet 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. 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. 16 CardioNet AECG System 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. If additional assistance is required contact customer support via telephone or fax listed below. Telephone: Fax: 619.243.7500 619.243.7700 Call customer support before returning a CardioNet Monitoring System to make shipping arrangements. 17 CardioNet AECG System 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. No connection when call button is pressed Ensure Monitor is turned ON. Return Monitor to Base for recharging. Check electrode placement and connections. Ensure Monitor is in cellular range. Place Monitor in base. Ensure Monitor is turned ON. 18 CardioNet AECG System 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 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 1.2A) 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 19 CardioNet AECG System 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. Detailed instructions covered in this section: - Monitor Screen Preferences - Automatic Download Preferences - Arrhythmia Detection Preferences - Disclosure of Technical Specifications 21 CardioNet AECG System 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 BID TID QID Q4 (Once per 24 hours) (Two times per 24 hours / every 12 hours) (Three times per 24 hours / every 8 hours) (Four times per 24 hours / every 6 hours) (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. 22 CardioNet AECG System 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 Bradycardia Tachycardia Irregular Rhythm to Detect Atrial Fibrillation / Flutter PVC’s Ventricular Bigeminy Ventricular Trigeminy Ventricular Tachycardia Ventricular Fibrillation Pause Long Pause Value < 40 BPM & sustained > 60 sec > 150 BPM & sustained > 60 sec Irregular HR (IRR > 25) > 60 sec > 8 occurrences in one minute > 6 occurrences in one minute > 6 occurrences in one minute > 100 BPM & sustained > 4 beats Onset > 2 seconds > 3 seconds *Irregular R to R is defined as: Standard deviation x 100 [0.01 sec] RR mean 23 CardioNet AECG System 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). 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 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 24 CardioNet AECG System 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. 25 CardioNet AECG System
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