PHYSICIAN’S INSERVICE MANUAL Model CN1006 (C5)
CONTACT INFORMATION CardioNet Monitoring Center Tel. 866-727-3397 • For all clinical issues • To extend or discontinue monitoring service • For “fetch requests” for additional ECG data Main Business Number Tel. 866-426-4404 • For non-clinical issues Physician Relations Hotline Tel. 800-242-3980 • Assistance with physician reimbursement for interpretation of MCOT To Fax in a Prescription • Use the number printed at the top of the Patient Prescription/Order Forms provided to your practice.
CONTENTS CARDIONET: MOBILE CARDIAC OUTPATIENT TELEMETRY 4 TECHNOLOGY OVERVIEW 5 SERVICE OVERVIEW 6 PHYSICIAN REPORTS 7 PRESCRIBING CARDIONET 8 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTOR 8 FOR USE ON ALL PATIENTS 9 TECHNICAL SPECIFICATIONS 10 TECHNICAL SPECIFICATIONS 11 IN-HOME REQUIREMENTS 12 FCC COMPLIANCE 13 ARRHYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS 13 HEART RATE MEASUREMENT REPORT 13 FCC RULES PART 68 13 REN 14 SERVICE 14 DISRUPTION OF THE NETWOR
CARDIONET: MOBILE CARDIAC OUTPATIENT TELEMETRY CardioNet developed and introduced 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.
TECHNOLOGY OVERVIEW CardioNet integrates patient monitoring, wireless communications technology, and the Internet to allow cardiac rhythm related problems to be quickly identified, quantified, and treated. The CardioNet System is comprised of a sensor with three leadwires, a monitor, and base. The lightweight sensor (invisible under clothing) is worn by the patient. It continuously records and analyses two channels of ECG and transmits the ECG by a radio frequency (RF) link to the monitor.
SERVICE OVERVIEW First, the prescribing physician is registered in the CardioNet service. All applicable contact and demographic data is collected and entered 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, the practice faxes a Patient Prescription/Order form to CardioNet along with the patient insurance information.
PHYSICIAN REPORTS Three types of reports may be issued to physicians during monitoring: • Daily Telemetry Reports: sent every 24 hours for all patients, which contains sample strips of arrhythmias detected and patient-reported symptoms, heart rate and AF frequency and duration data. • Urgent Reports: issued when an event occurs that the physician has defined as urgent. • Summary Reports: Provides a summary of all billable days of service.
PRESCRIBING CARDIONET Prescribing CardioNet monitoring for a patient is easy, once your practice has been enrolled in our service. Simply fill out a CardioNet Patient Prescription/Order Form, (provided to your practice when it was enrolled) sign it and fax it to the number listed on the top of the form.
10. Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes. 11. The device is intended to identify Cyclic Variation of Heart Rate (CVHR) pattern to evaluate need of further testing for sleep disorders FOR USE ON ALL PATIENTS The CardioNet MCOT system is intended for use on adults, children and infants weighing less than 22 pounds. Contraindications for use: 1.
TECHNICAL SPECIFICATIONS The technical specifications are subject to change. PHYSI CAL Sensor 3 inches x 1.9 inches x 0.7 inch; Weight: 3.0 oz. with battery Monitor 4.7 inches x 2.6 inches x 0.9 inch; Weight: 6 oz. LCD 2.27 inches x 1.7 inches; Touch screen: color Base 4.3 inches x 3.7 inches x 1.0 inches; Weight: 6.0 oz. FUNCTI ONAL Sample Rate 250 samples per second Resolution 12 bits Dynamic range + / - 5 mV Bandwidth 0.
TECHNICAL SPECIFICATIONS CONNECTI ONS Base Power in (15V, 1.2A max); Phone in (RJ-11); Phone out (RJ-11) Monitor Power in (15V, 1.2A max) Wall Adaptor Power in (100-240 VAC); Power out (15V, 1A or 15V, 1.
IN-HOME REQUIREMENTS 1. Touch tone, pulse telephone or cellular/PCS wireless coverage suitable for data transmission 2.
FCC COMPLIANCE FCC I D Sensor I SM QBI -1011 Monitor I SM QBI -1012 Monitor Cell Modem RI 7CC864-DVAL Base QBI -1013 ARRHYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS The CardioNet C5 System incorporates an arrhythmia analysis algorithm whose performance is presented below: The algorithm results were obtained from the respective databases in strict accordance with EC57 and with 0% downtime on both databases. Performance Measure MIT Arrhythmia Database Average QRS Detection Sensitivity % 99.
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).
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. BODY-WORN OPERATION This device was tested and was found to comply with the FCC exposure requirements. The device was also tested and passed SAR (Specific Absorption Rate) testing. For more information about RF exposure, please visit the FCC website at www.fcc.gov.
service. Use of CardioNet system with implanted pacemakers and ICDs (defibrillators) If the patient has an implanted pacemaker or defibrillator (ICD), the manufacturer may have recommended certain precautions when using a cellular phone. Since the CardioNet monitor contains a cellular phone, the patient should take the same precautions when carrying and using the monitor.
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. Refer to the Patient Education Guide for complete instruction on skin preparation, electrode placement, and removal.
