PHYSICIAN’S INSERVICE MANUAL Model CN1006 (C5) Page 1 of 17
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 13 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.
FOR USE ON ADULT AND PEDIATRIC PATIENTS ONLY The CardioNet MCOT system is intended for use on adults and children. It is not intended to be used on infants weighing less than 10 kg (22 pounds). Contraindications for use: 1. Patients with potentially life-threatening arrhythmias who require inpatient Monitoring. 2. Patients who the attending physician recommends should be hospitalized for ECG monitoring. 3.
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. Display 2.27 inches x 1.7 inches; Touch screen: color; OLED Technology 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-DUAL 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.
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). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact the local telephone company. Note: RENs are associated with loop-start and ground-start ports. It is not used for E&M and digital ports. The REN assigned to the Model CN1006 is 0.0B.
BODY-WORN OPERATION For body worn operation, this device has been tested and meets FCC RF exposure guidelines when used with an accessory that contains no metal and that positions the handset (Monitor) a minimum 1 cm from the body. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. For more information about RF exposure, please visit the FCC website at www.fcc.gov.
Avoid Electromagnetic Interference For the best recording results, avoid close proximity to heavy equipment or other sources of electromagnetic interference such as electric blankets, heating pads, water beds, etc. Potential for Electromagnetic Interference There is a potential for electromagnetic interference to other devices while using the CardioNet service.
are analyzed and confirmed by a certified cardiac technician (“CCT”). • There is an inherent time delay from when the event is analyzed and confirmed by the CCT to when CardioNet is able to make contact with the patient or his/her physician. • If a patient or physician is not accessible by telephone, CardioNet will not succeed in making contact with them.
