CONTENTS Contact Information ................................................................................ 2 Introduction ............................................................................................. 3 Product Description ................................................................................. 4 Service Overview ..................................................................................... 6 Patient Enrollment ...............................................................
CONTACT INFORMATION Main Number (215) 689-7450 (866) 426-4404 Patient Service Center (866) 727-3397 Physician Notification (866) 426-4401 Patient Inquiries Enrollment (866) 426-4403 Fax Billing (866) 426-4402 Caution: Federal law restricts this device to sale by or on the order of a physician.
INTRODUCTION CardioNet: Mobile Cardiac Outpatient Telemetry CardioNet has developed 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. CardioNet’s Mobile Cardiac Outpatient Telemetry assists physicians in the diagnosis and management of difficult-to-diagnose arrhythmias.
PRODUCT DESCRIPTION CardioNet merges patient monitoring, wireless communications, and the Internet to allow targeted cardiac rhythm related problems to be identified, quantified, and communicated to the prescribing physician in a timely and efficient manner. The CardioNet System is comprised of a sensor, monitor, and base. The lightweight sensor is worn by the patient on a lanyard or belt clip, it continuously records two channels of ECG, and transmits the ECG by a radio frequency (RF) link to the monitor.
CardioNet Monitor in Base The monitor continuously analyzes the ECG in real time as it is transmitted from the sensor. When an abnormal rhythm has been identified based on the monitoring parameters, the data is automatically sent via a wireless modem to the CardioNet Patient Service Center for additional review and interpretation by a certified monitoring specialist.
SERVICE OVERVIEW First, the prescribing physician is registered in the CardioNet service. All applicable contact and demographic data is collected and inputted into the CardioNet Patient Enrollment and Management System (PEMS) by a CardioNet representative.
Monitoring Specialists Review and Interpret Data to Ensure Accuracy The CardioNet Patient Service Center is staffed with highly qualified and experienced cardiac monitoring specialists. At a minimum, all monitoring specialists are CCT certified. They have extensive experience in cardiovascular monitoring; including the hospital based C.C.U. and I.C.U. telemetry, emergency medical services, and other cardiac call center environments.
PATIENT ENROLLMENT The Patient Enrollment Form is located in the CardioNet Patient Enrollment and Management System (PEMS). The client can access the CardioNet Patient Enrollment and Management System application at www.cardionet.com. This is a secure and restricted website and the user is required to be enrolled as a CardioNet client. Forms are also available from the CardioNet Patient Service Center. If you are not a CardioNet registered user, please contact the Patient Service Center.
The Patient Prescription Form includes the patient name, prescribing physician, physician group name, and duration of monitoring requested, diagnosis and ICD-9 code. Using this form input all the appropriate information in the fields listed. The prescribing physician is required to sign the CardioNet Patient Prescription Form prior to enrolling the patient. Please fax both completed forms, including a copy of the patient’s insurance card to the CardioNet Patient Service Center.
ELECTRONIC PATIENT ENROLLMENT CardioNet provides an additional method for enrolling patients in our service, electronic enrollment. If the user prefers to use CardioNet’s electronic enrollment process, you can access the CardioNet Patient Enrollment and Management System (PEMS) application at www.cardionet.com. Use the Physician Log In and enter the username and password, and then click on Enroll Patient. The application will open to Patient Demographics.
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTOR Indications for Use 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 light-headedness 3. Patients with palpitations 4. Patients with syncope of unknown etiology 5.
REPORTS When a physician group and/or physician is enrolled in CardioNet’s service, preferred reporting methods for different events (Internet, fax, mail or telephone) are established for each physician user. Physicians may elect to modify or change their preferred report delivery methods by selecting “Modify Physician” in the CardioNet Patient Enrollment and Management System, or contacting the CardioNet Patient Service Center directly.
A Representative ECG for the Urgent Report The Urgent Report provides a six second sample of the patient’s ECG, Channel 1 and 2. The report includes a time and date stamp of the actual event, preliminary findings of the CardioNet monitoring specialist, symptoms and activities reported by the patient, and how the event was initiated, automatic or patient initiated.
PHYSICIAN NOTIFICATION As part of the CardioNet client enrollment process, the Physician Notification criteria will be established for the client (physician practice) or individual prescribing physician. The Physician Notification Order Form (MON305) is to be completed and signed prior to enrolling a patient on CardioNet’s service. CardioNet’s Medical Advisory Board provides a set of default values based on established clinical practice monitoring guidelines.
BILLING The patient is responsible for providing the CardioNet Patient Service Center with all applicable insurance information at the time of enrollment. CardioNet will bill the patient’s primary insurance company. In addition, CardioNet will also bill the secondary insurance company, if provided by the patient. A copy of the patient’s insurance card is to be provided with the enrollment. The patient/responsible party/legal guardian is required to sign the Patient Enrollment Form.
Physician Reimbursement Coding Guidelines The LMRP determined that no existing CPT code fully and accurately describes this new technology; therefore services should be reported by using CPT Code 93799 and include the narrative “ECG arrhythmia detection and alarm system.” Providers are instructed to bill one (1) unit of procedure code 93799, per day of cardiac surveillance.
PRECAUTIONS Dispose of Batteries Properly Observe all local laws for the disposal of alkaline batteries. When Not in Use, Remove Sensor Battery Do not leave the battery in the sensor when it is not in use. Damage from corrosion could result. Avoid Electromagnetic Interference For the best recording results, you should avoid close proximity to heavy equipment or other sources of electromagnetic interference such as electric blankets, heating pads, water beds, etc.
CAUTIONS AND WARNINGS Caution: Power Down and Remove Sensor Before Showering Power down the monitor and remove the sensor before showering. While the CardioNet sensor and monitor are water resistant, they are not waterproof. Refer to the Patient Education Guide for complete instruction on removal and reapplication before showering. Caution: Do Not Get the Monitor and Sensor Wet Make sure the monitor and sensor stay dry at all times.
TECHNICAL SPECIFICATIONS Physical Sensor 2.7 in. x 0.9 in height Weight: 2.2 oz Sensor neck strap 24 in. Monitor 5.8 in x 3.0 in x 1.1 in Weight: 12.8 oz LCD 3.0 x 2.3, touch screen, monochrome, backlight Base 7.8 in x 4.3 in x 6.1 in Weight: 13.3 oz Functional Sample Rate 250 samples per second Resolution 12 bits Dynamic Range + / -5 mV Bandwidth 0.
Operating conditions Operating temperature 20 - 45 o C Operating humidity 10% - 95%, noncondensing Storage temperature -20 - 55 o C, noncondensing Storage humidity 5% - 95%, noncondensing Operation altitude 700-1060 millibars Fluid Ingress Rating IPX1 Note: Please protect the monitor and sensor from water and other fluids. Connectors Base Monitor Power in (15V, 1.2A max) Phone in (RJ-11) Phone out (RJ-11) Power in (15V, 1.2A max) Wall Adapter Manufacturer Friwo, Inc. (15V, 1.
Standards Compliance Monitor EN60601-1 AAMI EC-38 FCC parts 2, 15, 22, 24 Sensor EN60601-1 AAMI EC-38 FCC part 15 Base EN60950 AAMI EC-38 FCC part 15, 68 AECG Equipment Class II Note: This equipment has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN60601-1-2:1994, Medical Device Directive 93/42/EEC or the Electromagnetic Compatibility Directive 89/336/EEC (use applicable directive).
EQUIPMENT SYMBOLS Consult Manual Year of Manufacture 2000 Type BF Equipment SN Serial Number HARDWARE REQUIREMENTS In Home Requirements Touch tone telephone AC powered outlet FCC ID Sensor QBI-1007 Monitor QBI-1006 Monitor cell NBZNRM-6832 Base CARDT00B42061 22
ARRYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS The CardioNet System incorporates an arrhythmia analysis algorithm whose performance is presented below: The algorithm results were obtained from the respective databases in strict accordance with EC-57 and with 0% downtime on both databases. Performance Measure MIT Arrhythmia Database AHA Database QRS Detection Sensitivity % 99.93 99.88 QRS Detection Positive Predictivity % 99.85 99.89 PVC Detection Sensitivity % 95.44 94.
HEART RATE MEASUREMENT REPORT The performance of the analysis algorithm for heart rate detection on standard databases is shown below. The average RMS errors for the AHA, MIT-arrhythmia, and NST databases are 2.08%, 1.07%, and 30.9% respectively. Heart Rate Calculation The average heart rate is calculated by computing the mean of the actual RR-intervals, in the last 6 seconds or 8 RR-intervals (whatever is shorter).
RUN-BY-RUN REPORT AHA ECG Database Record CTs CFN CTp CFP STs SFN STp SFP LTs LFN LTp Sum 904 53 95 1048 35 379 85 487 12 26 LFP CSe C+P SSe S+P LSe L+P 75 4 Gross 90 97 82 98 33 95 Average 72 78 55 97 76 91 Total couplets: 999 Total short runs: 464 Total long runs: 79 MIT-BIH Arrhythmia Database Record CTs CFN CTp CFP STs SFN STp SFP LTs LFN LTp LFP CSe C+P SSe S+P LSe L+P Sum 564 84 3 0 575 35 32 20 42 5 10 15 Gross 87 94 62 89 77 100 Average 78 74 60
FCC and Industry Canada (CS-03) Compliance This device complies with part 15 and 68 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and, (2) This device must accept interference received including interference that may cause undesired operation. FCC Rules Part 15 The Model 1001 has been tested and complies with the limits for a class A digital device, pursuant to Part 15 of the FCC Rules.
Service In the event of equipment malfunction, all repairs should be performed by CardioNet Inc. or an authorized agent. It is the responsibility of users requiring service to report the need for service to CardioNet Inc. or to one of our authorized agents. Service can be facilitated through our office at: CardioNet Inc. 510 Market St.
BODY-WORN OPERATION This device was tested with the softcase supplied by CardioNet as an accessory to this device and was found to comply with the FCC exposure requirements. When operating this device, a minimum separation distance of 1.5 cm must be maintained between the users body and the monitor, including its antenna, to comply with the FCC exposure limits. To maintain compliance with FCC RF exposure requirement, use only carrying accessories that maintain a 1.
SAMPLE FORMS AND REPORTS Examples of the forms listed below follow. ! Patient Enrollment Form ! Physician Enrollment Form ! Client Enrollment Form ! Patient Prescription Form ! Physician Notification Orders Form ! Physician Notification Change Orders Form ! Daily Mobile Report ! Urgent Mobile Telemetry Report ! End of Service Report To access electronic versions of forms and reports, log on to www.cardionet.com..
