QBI-1001CardioNet Sensor

i Patient Information Guide This device complies with part 15 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. CardioNet Home Ambulatory Cardiac Monitor CardioNet Inc. 510 Market Street San Diego, CA 92101 Tel. 619. 243.7500 Fax. 619. 243.7700 ii Copyright 2002 All rights reserved. Document Number - 100132 Revision C Model Number 1001 iii 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 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 Keep the Monitor On ........................................................................... 18 Navigating the Screens ....................................................................... 20 Record a Symptom ............................................................................. 23 When You Are Without Cell Phone Coverage ...................................... 26 Changing Monitor Options .................................................................. 27 Checking Monitor Status ..................................................................... 29 View the Cell Signal Status ................................................................. 31 Warnings and Alarms .......................................................................... 32 4. Care for the Sensor .............................................. 33 Changing Electrode Pads ................................................................... 34 Placing the Leads and Pads .............................................................. 37 Showering or Bathing ......................................................................... 38 Changing the Battery.......................................................................... 40 Turn Off the Monitor............................................................................ 40 Replace The Battery........................................................................... 40 5. TroubleShooting ................................................... 41 Responding to Warnings and Alarms .................................................. 43 Precautions........................................................................................ 47 A. Specifications ....................................................... 51 iv 1. Introduction Introduction The CardioNet Service monitors your heart rhythms continuously. This helps your doctor detect problems that occur infrequently, even while you sleep. We Help Find Answers 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, since an in-office ECG may only monitor the heart for ten or fifteen seconds. By monitoring heart rhythms continuously, we can help physicians detect problems that may occur infrequently – perhaps only once or twice a week –even while you are asleep. 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. CardioNet works with you and your physician. 1 2 Introduction 1. Introduction 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. How the CardioNet Service Works Patient Wears CardioNet Sensor Lightweight Sensor monitors each heartbeat. CardioNet Monitor sends heart data to the CardioNet Center Introduction 3 1. Introduction The CardioNet Service Center Monitors Heart Data At the CardioNet Service Center, which operates 24 hours a day, seven days a week, specially trained cardiac technicians analyze your heart data and report results to your physician. Your Physician Reviews The 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 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 need to use the equipment, which is in limited supply. Your Service Kit contains 1. The CardioNet Monitor This portable device constantly monitors your heartbe…

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From: George Tannahill [[email protected]] Sent: Friday, April 12, 2002 12:51 PM To: [email protected] Subject: RE: Composite filings Judy, Are the units always used together? Can they ever be used separately or with another similar device? If they must always be used together or are permanently attached they are allowed to be submitted as a composite. George >>> <[email protected]> 04/11/02 11:12AM >>> George, These are 2 separate units, but are sold as a system because they work together. Does that still qualify? Judy -----Original Message----- From: George Tannahill [mailto:[email protected]] Sent: Thursday, April 11, 2002 7:36 AM To: [email protected] Subject: Re: Composite filings Judy, A composite device is a device which is in one enclosure but the device has more than one mode and operates under different equipment type codes. From the description provided it appears the device is a composite. George Tannahilll >>> <[email protected]> 04/09/02 05:30PM >>> George, Can I do a composite filing using 2 different Parts? We have a system (heart monitor) that is a Part 15 transmitter and the other part is Part 22. It uploads to a computer through phone or satellite. Judy

TÜV PRODUCT SERVICE 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 02 July 2002 Chief, Equipment Authorization Branch Federal Communications Commission P. O. Box 358315 Pittsburgh, PA 15251-5315 RE: Application for CARDIONET, Monitor FCC ID: QBI-1002 Dear Sir/Madam: The FCC ID for the Cardionet Monitor has been changed to: FCC ID: QBI-1002. The label content and location have been uploaded per email communication from Andy Leimer requesting a separate FCC ID and filing for the monitor. Sincerely, Judy Evans Technical Writer

February, 2000 APREL Project No.: NVWB-MINSTREL III-3377 Table of Contents Wireless CDPD Modem Minstrel III FCC ID: NBZNRM-6832 Novatel Wireless Technologies Ltd. Class II Permissive Changes C C O O V V E E R R L L E E T T T T E E R R Exhibit 1: a. Authorization Letter b. Letter from Novatel Wireless describing the changes involved in Class II Permissive Changes Exhibit 2: RF Power Output Measurements (ERP) Report Exhibit 3: SAR Reports (2) Exhibit 4: Declaration of Conformity Certificate, FCC Part 15, Subpart B, Class B Exhibit 5: Photographs of the Equipment Note: - All other documents have been submitted with the original Submission Under FCC ID: NBZNRM 6832

SENSOR

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TÜV PRODUCT SERVICE 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. 201108-08 Part 15 Page 1 Rev.No 1.0 MEASUREMENT AND TECHNICAL REPORT CARDIONET 510 Market Street San Diego, CA 92101 DATE: 15 April 2002 This Report Concerns: Original Grant: X Class II Change: Equipment Type: Cardionet ECG Monitor with Arrhythmia Detection, Model 1001 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, Paragraph 15.107(a); 15.109(a); 15.249 Report Prepared by: TÜV PRODUCT SERVICE 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 546 3999 Fax: 858 546 0364 TÜV PRODUCT SERVICE 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. 201108-08 Part 15 Page 2 Rev.No 1.0 TABLE OF CONTENTS Pages 1 GENERAL INFORMATION 3 1.1 Product Description 3 1.2 Related Submittal Grant 5 1.3 Tested System Details 5 1.4 Test Methodology 5 1.5 Test Facility 5 2 SYSTEM TEST CONFIGURATION 6 2.1 Justification 6 2.2 EUT Exercise Software 6 2.3 Special Accessories 6 2.4 Equipment Modifications 6 2.5 Configuration of Tested System 6 3 RADIATED EMISSION EQUIPMENT/DATA 7 Field Strength Calculation 17 4 CONDUCTED EMISSION EQUIPMENT/DATA 18 5 Attestation Statement 24 Form EMC Test Plan and Constructional Data Form EUT Description Ambulatory ECG Monitor with Arrhythmia Detection EUT Name CardioNet ECG Monitor with Arrhythmia Detection Model No.: 1001 Serial No.: Product Options: None Configurations to be tested: Standard Operational Mode Power Requirements Voltage: 15VDC (If battery powered, make sure battery life is sufficient to complete testing.) Current (Amps/phase(max)): 1.1 Current (Amps/phase(nominal)): 0.5 Typical Installation and/or Operating Environment For use at home by a heart patient. EUT Power Cable Permanent OR Removable Length (in meters): 3m wall adapter EUT Interface Ports and Cables Interface Shielding Type Type Termination Connector Type Port Termination 56kbs Analog Modem 2 Twisted Pair POTS 4 RS-232 1 Foil over twisted pairs Molded Insulated DB9 Standard RS-232 Termination 1 EUT Software . Revision Level: Rev. 76 Description: CardioNet embedded software load EUT Operating Modes to be Tested 1. Typical Operating Mode. 2. Monitor placed in continuous CW operation for radiated power tests. 3. Sensor placed in continuous CW operation for radiated power tests. FILE: EMCU_F09.02E, REVISION 0, Effective: October 26, 1999 Page 1 of 6 Form EMC Test Plan and Constructional Data Form EUT System Components Description Model # Serial # FCC ID # Monitor Unit 1001 Sensor Unit None Base Unit None Oscillator Frequencies Frequency Derived Frequency Component # / Location Description of Use 26MHz 900MHz ISM Band Monitor / Y2 Reference for ISM Transceiver 4MHz 4MHz Monitor / Y1 uP Clk 3.6854MHz 133MHz Monitor / Y3 uP Clk 32.768KHz 32.768KHz Monitor / Y4 uP Timer 26MHz 900MHz ISM Band Sensor / Y2 Reference for ISM Transceiver 4MHz 4MHz Sensor / Y1 uP Clk Power Supply Manufacturer Model # Serial # Type Friwo 7555M/15 N/A Switched-mode: (Frequency) 60kHz to 120kHz Linear Other: at short circuit frequency can go down to 8kHz Critical EMI Components (Capacitors, ferrites, etc.) Description Manufacturer Part # or Value Qty Component # / Location Ferrite Bead Spectrum Control, Inc. FCV-0805- A601P 3 on Base Unit Ref designator L2 - L4 EMC Critical Detail Transient suppressors, filters, circuit layout with vias reduce RF noise. Voltage transients have been minimized by implementing good power-supply busing. To reduce voltage transients, the supply line's parasitic inductances as low as possible by reducing trace lengths, using wide traces, ground planes. Saw filters are used in our RF section to achieve low insertion loss and high stop band attenuation FILE: EMCU_F09.02E, REVISION 0, Effective: October 26, 1999 Page 2 of 6 TÜV PRODUCT SERVICE 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. 201108-08 Part 15 Page 5 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 15.249 Pass Test Performed: X 1. Conducted Emissions, FCC Part 15, Paragraph 15.107(a) X 2. Radiated Emissions, FCC Part 15, Paragraph 15.109(a); 15.249 3. Radiated Emission per FCC Part 2, Paragraph 2.1053, & Part 22, Paragraph 22.917 4. Engineering evaluations 5. Frequency Stability, Part 2, Paragraph 2.995, and Part 87, Paragraph 87.133 RF Output Power, Part 2, Paragraph 2.985, Part 22, Paragraph 22.917 Both Conducted and radiated testing were performed according to the procedures in FCC/ANSI C63.4 and CSA 108.8 - M1983. Radiated testing was performed at an antenna-to-EUT distance of 3 meters (1 - 25 GHz). 1.5 Test Facility The open area test site and conducted measurement data were tested by: TÜV PRODUCT SERVICE 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 546 3999 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 PRODUCT SERVICE 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. 201108-08 Part 15 Page 6 Rev.No 1.0 2. SYSTEM TEST CONFIGURATION 2.1 Justification The EUT was initially tested for FCC emission in the following configuration: See Block Diagram. 2.2 EUT Exercise Software None 2.3 Special Acce…

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