QBI-1007Sensor

HOME HEART MONITORING Patient Education Guide Contents i DRAFT TABLE OF CONTENTS 1. INTRODUCTION...................................................................................... 1 How the CardioNet Service Works ............................................................ 2 The CardioNet Monitoring Kit ................................................................... 4 Who to Call for Help ................................................................................... 8 2. SETTING UP............................................................................................ 9 Connecting At Home ............................................................................... 10 Setting Up the Base .................................................................................. 11 Checking Battery Power........................................................................... 12 Staying in Range ........................................................................................ 12 Limitations of Cell Phone Coverage ....................................................... 12 Wearing the CardioNet Sensor ................................................................ 14 Placement of Lead Wires and Pads ......................................................... 15 3. USING THE MONITOR .......................................................................... 17 Monitor On and Off .................................................................................. 18 Using the Touch Screen ............................................................................ 20 Recording a Symptom.............................................................................. 23 When You Are Without Cell Phone Coverage ....................................... 27 Changing Monitor Options...................................................................... 28 Checking Monitor Status.......................................................................... 30 Viewing the Cell Signal Status .................................................................. 32 Warnings and Alarms ................................................................................ 33 4. SENSOR CARE ....................................................................................... 35 Changing Electrode Pads......................................................................... 36 Placing the Leads and Pads .................................................................... 39 Showering or Bathing............................................................................... 40 Changing the Battery ................................................................................ 42 5. TROUBLE SHOOTING........................................................................... 43 Responding to Warnings and Alarms ..................................................... 44 Cautions..................................................................................................... 56 6. SPECIFICATIONS, COMPLIANCE AND SYMBOLS ................................ 59 ii DRAFT Caution:Caution: Caution:Caution: Caution: Federal law restricts this device to sale by or on the order of a physician. Copyright 2004 All rights reserved Model Number 1001 Lit Number - 100526 !! !! ! Revision B !! !! ! February 2004 Introduction 1 INTRODUCTION We Help Find Answers The CardioNet Service monitors your heart rhythms continuously. This helps your doctor detect problems that occur infrequently, even while you sleep. CardioNet works with you and your physician. The CardioNet Service was developed to help doctors detect and treat heart problems that may not happen often enough to be found during a routine ECG in the physician’s office. CardioNet monitors heart rhythm continuously, while people go about their normal daily activities. We can help physicians detect problems that may occur infrequently, whether you feel them or not, even while you are sleeping. Our goal at CardioNet is to work as a team with patients and physicians to help people receive the best possible care. We are honored that we were chosen to serve you. 1 2 Introduction 1. Introduction HOW THE CARDIONET SERVICE WORKS When you’re using the CardioNet Service, you’ll wear a small, lightweight sensor. The sensor monitors each heartbeat and sends data to the portable CardioNet monitor. The CardioNet monitor can be tucked away in a pocket or purse. It sends wireless communications to the CardioNet Center automatically when it detects an event, or when you report an event using the touch screen on the monitor. Sensor with lead Wires Lightweight sensor monitors each heartbeat. CardioNet monitor sends your information to the CardioNet Center 1. Introduction Introduction 3 CardioNet Patient Service Center Monitors Heart Rhythms The CardioNet Patient Service Center operates 24 hours a day, seven days a week. At the Center, specially trained cardiac technicians analyze your heart rhythms and report results to your physician. Physician Reviews Results Your physician reviews the results, discusses results with you and prescribes or adjusts treatment. 4 Introduction 1. Introduction THE CARDIONET MONITORING KIT The CardioNet Monitoring Kit contains the supplies you will need while you are on the CardioNet Monitoring Service. If any items are missing or broken, or if you have any questions about how to use them, please call the CardioNet Patient Service Center at 1-866-426-4401. When service is ended, please return all the items to their labeled slots and send the kit back to the monitoring center, following the directions on the enclosed return address label. It is important to return the patient supply kit no later than the very next day. Other patients may need to use the equipment. YOUR SERVICE KIT CONTAINS 1.1. 1.1. 1. The CardioNet MonitorThe CardioNet Monitor The CardioNet MonitorThe CardioNet Monitor The CardioNet Monitor This portable device constantly monitors your heartbeat and s…

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1 CONTENTS Contact Information ................................................................................ 2 Introduction............................................................................................. 3 Product Description ................................................................................. 4 Service Overview..................................................................................... 6 Patient Enrollment ................................................................................... 8 Electronic Patient Enrollment ................................................................ 10 Indications and Contraindications .......................................................... 11 Reports.................................................................................................. 12 Physician Notification ............................................................................ 14 Billing..................................................................................................... 15 Cautions and Warnings .......................................................................... 17 Technical Specifications ......................................................................... 19 Sample Forms and Reports ................................................................... 28 DRAFT 2 Copyright 2004 All rights reserved Lit Number - 100327 !! !! ! Revision E !! !! ! February 2004 Caution: Federal law restricts this device to sale by or on the order of a physician. 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 3 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. Given the infrequent and asymptomatic nature of some arrhythmias, it is often challenging to capture an actual arrhythmia with conventional monitoring technology, such as Holter and cardiac event monitoring. With the CardioNet System, we are able to automatically detect and capture asymptomatic and symptomatic arrhythmias, based on monitoring parameters defined by the prescribing physician. In addition, the patient can utilize the touch screen on the CardioNet monitor to enter their symptoms and activity level at the time of a documented event. The physician then receives a representative ECG strip of the event; a time and date stamp of the actual event, including symptoms and activity, and is therefore able to make a more informed and accurate diagnosis. CardioNet outpatient telemetry offers physicians a powerful new diagnostic and patient management tool for a wide range of monitoring indications. Physician Receives CardioNet Report Patient Enters Symptoms and Activities Patient Monitored 24/7/365 4 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. The sensor is powered by a disposable alkaline battery, which typically lasts 24-36 hours. While using the sensor, the patient is required to wear (3) disposable electrodes to record their ECG. The monitor is approximately the size of a PDA device. It has a powerful microprocessor, extensive memory, imbedded algorithm, LCD display, wireless modem, and a global positioning system (GPS). The monitor is powered by a rechargeable lithium battery, which typically lasts 18 hours. The monitor’s microprocessor is programmed to identify cardiac rhythm problems within guidelines established by the prescribing physician. The algorithm detection parameters and physician notification criteria are individualized for each patient and physician. Sensor with Lead Wires 5 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. In the case of a patient-initiated event, the monitor automatically prompts the patient to enter their symptoms and activities from a predetermined list on the touch screen display. When the patient is at home and an event occurs while the monitor is in the base, the patient’s normal telephone line is used to transmit the data. If an event occurs when the patient is in an area where cellular coverage is inadequate, the patient may elect to transmit their ECG directly, using a regular telephone. The base utilizes an AC power supply and is connected to the patient’s telephone line. The base also consists of two antennas, which allows the patient to have an expanded RF range within their home. When the patient is mobile, the RF range or leash length between the monitor and sensor is estimated to be 25-50 feet. The sensor and monitor are designed to alert the patient if and when they are out of RF range or cellular coverage. The CardioNet monitor has sufficient memory to store a minimum of twenty-four hours of the patient’s ECG. A daily protocol exists to upload the patient’s 24-hour ECG data, including related events and trends from the monitor to the Patient Service Center. CardioNet Monitor …

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SENSOR SENSOR LABEL LOCATION

NOTE: BLANK AREA IN CENTER OF LABEL WILL CONTAIN A 3 OF 9 BARCODE AND THE SERIALNUMBER SEQUENCE SPECIFIED ON THE PO FOR PART NUMBER 220-0030-01 THE INFORMATION CONTAINED IN THISDRAWING IS THE SOLE PROPERTY OFCardioNet Inc. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OFCardioNet Inc IS PROHIBITED. PROPRIETARY AND CONFIDENTIAL NEXT ASSY USED ON APPLICATION DO NOT SCALE DRAWING FINISH MATERIAL DIMENSIONS ARE IN INCHESTOLERANCES:FRACTIONAL 1/32ANGULAR: MACH 1 BEND 1.5TWO PLACE DECIMAL .01THREE PLACE DECIMAL .005 A SIZE SCALE:2:1 DWG. NO. WEIGHT: SHEET 1 OF 1 REV. 510 MARKET STREETSAN DIEGO CA 92101 TITLE: 220-0031-01 A SEE NOTES A ZONE APPROVED DATE DESCRIPTION REV. REVISIONS PSL 1/12/04 PSL NAME DATE COMMENTS: Q.A. MFG APPR. ENG APPR. CHECKED DRAWN SEE NOTES PSL 1/12/04 1/12/04 PRODUCTION RELEASE ECO# 1058 1/12/04 PSL ARTWORK - SENSORDFMA SENSOR LABEL LOCATION

SENSOR PCB WITH LEAD WIRES SENSOR PCB TOP SENSOR PCB BACK SENSOR PCB WITH SHIELD SENSOR PCB BOTTOM PCB TOP

TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC305425-03 Page 1 of 74 Rev.No 1.0 MEASUREMENT AND TECHNICAL REPORT CARDIONET 510 Market Street San Diego, CA 92101 DATE: 16 January 2004 This Report Concerns: Original Grant: X Class II Change: Equipment Type: CardioNet System Sensor, S/N CN0340093 Deferred grant requested per 47 CFR 0.457(d)(1)(ii)? Yes: Defer until: No: X Company Name agrees to notify the Commission by: N/A of the intended date of announcement of the product so that the grant can be issued on that date. Transition Rules Request per 15.37? Yes: *No: X (*) FCC Part 15, Paragraphs 15.2471(a), (b); (c); (d) Report Prepared by: TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 Fax: 858 546 0364 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC305425-03 Page 2 of 74 Rev.No 1.0 TABLE OF CONTENTS Pages 1 GENERAL INFORMATION 4 1.1 Product Description 4 1.2 Related Submittal Grant 6 1.3 Tested System Details 6 1.4 Test Methodology 6 1.5 Test Facility 6 2 SYSTEM TEST CONFIGURATION 7 2.1 Justification 7 2.2 EUT Exercise Software 7 2.3 Special Accessories 7 2.4 Equipment Modifications 7 2.5 Configuration of Tested System 7 3 RADIATED EMISSIONS, 15.207(a) 8 3.1 Equipment 8 3.2 Field Strength Calculation 9 3.3 Data 10 4 FREQUENCY CHANNEL SEPARATION, 15.247(a)(1) 12 4.1 Equipment 12 4.2 Data 13 5 TIME OF OCCUPANCY / NUMBER OF HOPPING FREQUENCIES / CHANNEL BANDWIDTH, 15.247(a)(1)(i) 14 5.1 Equipment 14 5.2 Data Time of Occupancy 15 5.3 Data Number of Hopping Frequencies 16 5.4 Data Channel Bandwidth 18 6 RF POWER OUTPUT; 15.247(b)(2) 21 6.1 Equipment 21 6.2 Data 22 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC305425-03 Page 3 of 74 Rev.No 1.0 TABLE OF CONTENTS Pages 7 RADIATED SPURIOUS EMISSIONS; 15.247(c); 15.205(a) 23 7.1 Equipment 23 7.2 Data 24 8 CONDUCTED SPURIOUS, 15.247(c) 25 8.1 Equipment 25 8.2 Data 26 9 PEAK POWER DENSITY; 15.247(d) 72 9.1 Equipment 72 9.2 Data 73 10 ATTESTATION STATEMENT 74 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC305425-03 Page 4 of 74 Rev.No 1.0 1 GENERAL INFORMATION 1.1 Product Description General Equipment Description EUT Description: Heart Monitoring Device EUT Name: CardioNet System Model No.: Serial No.: Monitor: CNM880272 Sensor: CN0340093 EUT Specifications and Requirements Length: 5.8” Width: 3” Height: 1.1” Weight: 12.8oz. Power Requirements Voltage: 15V DC out (If battery powered, make sure battery life is sufficient to complete testing.) # of Phases: 1 phase 100-240 VAC, 60Hz., 400mA input Current (Amps/phase(max)): 1.5A Current (Amps/phase(nominal)): 1A Typical Installation and/or Operating Environment: Home EUT Power Cable: Removable and unshielded EUT Interface Ports and Cables Interface Shielding Type Type Termination Connector Type Port Termination Special Interface on bottom of Monitor (not shipped to customer) X 1 X Foil over braid Coaxial Mmi BB-25 TTL 0.5 X TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC305425-03 Page 5 of 74 Rev.No 1.0 EUT Operating Modes to be Tested 1. Normal Operating Mode where Monitor and Sensor communicate FHSS. 2. Special Operation Mode where Monitor and Sensor can each independently transmit on low, mid & High bands. EUT System Components Description Model # Serial # FCC ID # CARDIONET MONITOR DFMA QBI-1006 CARDIONET SENSOR DFMA QBI-1006 Support Equipment : NONE Oscillator Frequencies Frequency Derived Frequency Component # / Location Description of Use 3.68MHz 3.68MHz YZ on Sensor MicroProcessor 25MHz 25MHz Y1 on Sensor RF Reference crystal for PLL 3.68MHz 3.68MHz Y3 on Monitor MicroProcessor 25MHz 25MHz Y4 on Monitor RF Reference crystal for PLL 3.68MHz 3.68MHz Y1 on Monitor MicroProcessor 37.8MHz 300MHz Y2 on Monitor MicroProcessor 24.6MHz 24.6MHz Y5 on Monitor Audio Codes 20MHz 20MHz Y6 on Monitor LAN 12MHz 12MHz Y7 on Monitor USB 32.8kHz 32.8kHz Y8 on Monitor Real-Time Clock Power Supply Manufacturer Model # Serial # Type FNWO FW7555M/IS None X Switched-mode: (Frequency) 95 kHz Linear Other: Power Line Filters - None, Sensor is battery operated. Monitor is powered from mains w/non-OGM wall adapter. Critical EMI Components (Capacitors, ferrites, etc.) - None EMC Critical Detail: Shielding of currents on Monitor and Sensor PWB using cans. TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC305425-03 Page 6 of 74 Rev.No 1.0 1 GENERAL INFORMATION (continued) 1.2 Related Submittal/Grant None 1.3 Tested System Details The FCC IDs for all equipment, plus descriptions of all cables used in the tested system are: None 1.4 Test Methodology Purpose of Test: To demonstrate compliance with the ANSI C63.4 setup. TEST FCC CFR 47 # PASS/FAIL Radiated Frequency Channel Separation Time of Occupancy / Number of Hopping Frequencies / Channel Bandwidth RF Power Output Radiated Spurious Emissions Conducted Spurious Modulation Peak Power Density 15.207(a) 15.247(a)(1) 15.247(a)(1)(i) 15.247(b)(2) 15.247(c); 15.205(a) 15.247(c) 15.247(d) Pass Pass Pass Pass Pass Pass Pass Tests were performed according to the procedures in FCC/ANSI C63.4 and CSA 108.8 -M1983. 1.5 Test Facility The open area test site and conducted measurement data were tested by: TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 Fax: 858 546 0364 The Test Site Data and performance comply with ANSI 63.4 and are registered with the FCC, 7435 Oakland Mills Rd, Columbia Maryland 21046. All Measurement Data is acquired according to the content of FCC Measurement Procedure and ANSI C63.4, unless supplemented with additional requirements as noted in the test report. TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-29…

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