THL-000AG101EXD

AngelMed Guardian ® External Device (EXD) User’s Manual 2 Table of Contents 1 Introduction................................................................ 4 2 Guardian System Overview ...................................... 4 2.1 System Components .................................................... 4 2.2 Indications & Contraindications.................................. 5 2.3 Intra-System Communication...................................... 5 2.4 Available Literature..................................................... 7 3 EXD Device Description ............................................ 8 3.1 How Supplied .............................................................. 8 3.2 Appearance .................................................................. 8 3.3 Neck Cord & Belt Case ............................................. 10 3.4 Alarm & Alert Functionality ..................................... 12 3.5 Certifications ............................................................. 15 4 Setup.......................................................................... 16 5 Care & Maintenance................................................ 17 5.1 Battery Power ............................................................ 17 5.2 General Care & Maintenance Items .......................... 20 6 Electromagnetic Interference Precautions ............ 21 6.1 Sources of Strong EMI .............................................. 21 6.2 Cell Phone Precautions.............................................. 22 6.3 Security System Precautions ..................................... 22 7 Troubleshooting ....................................................... 23 8 Service & Support.................................................... 23 8.1 Service ....................................................................... 23 8.2 Technical Support...................................................... 24 3 9 Specifications ............................................................ 24 10 Index.......................................................................... 26 4 1 Introduction The AngelMed Guardian ® External Device (EXD), a battery-operated hand-held telemetry device, is one of five primary components of the Guardian System. This manual describes how to use and maintain the EXD. 2 Guardian System Overview The Guardian System detects changes in patients’ electrograms, using baseline electrograms from the previous day for comparison. If a change exceeds a pre-specified threshold, the system warns the patient and stores pertinent data for subsequent review. Two levels of warnings are possible: emergency alarms, for significant events that require immediate medical attention, and “see doctor” alerts, for less-significant events that require medical attention as soon as possible (e.g., in 1-2 days.) 2.1 System Components The Guardian System has five components: External Device (EXD) – a hand-held telemetry device that warns the patient of alarms and alerts via beeps and a red or yellow flashing LED, and is used to silence alarms and alerts. The EXD is also used for communication between the Programmer and the IMD. Implantable Medical Device (IMD) – an implantable programmable device that vibrates to warn the patient of 5 alarms and alerts, and stores electrogram signals and other data. Lead – a standard bipolar cardiac lead (St. Jude Medical Model 1488T) that is attached to the right ventricle. Lead Adapter – an adapter that connects the lead to the IMD and houses the antenna. Programmer – a customized computer that allows the physician to program IMD parameters and alarm settings for each patient. It also enables the physician to retrieve and review data collected by the IMD. 2.2 Indications & Contraindications The Guardian System is contraindicated when neither the patient nor patient caregiver can take appropriate action in response to alarms and alerts. Indications and contraindications for the EXD and IMD, individually, are discussed in the AngelMed Guardian ® Clinical Study Protocol. 2.3 Intra-System Communication Figure 1 shows the Guardian System communication architecture. The following points can be seen: • The EXD is the “hub” of communication between the IMD and Programmer. The EXD is used to set up communication sessions between the IMD and Programmer, in order to retrieve IMD data and set IMD parameters. It is also used to silence alarms and alerts. 6 • The EXD uses both near field and far field telemetry. Near-field telemetry (maximum distance of 5 cm or 2 inches) is used to silence alarms and alerts and to establish communication sessions between the IMD and Programmer. Far-field telemetry (maximum distance of 1.8 meters or 6 feet) is used for communication between the IMD and EXD after a session has been established and to initiate synchronous alarms and alerts on the EXD and IMD. • The EXD and Programmer each contain a serial port that allows them to be connected via cable. Fig. 1: Guardian System Communication Architecture 7 2.4 Available Literature • AngelMed Guardian ® Clinical Study Protocol • AngelMed Guardian ® Implantable Medical Device (IMD) User’s Manual • AngelMed Guardian ® Lead Adapter Instructions for Use • AngelMed Guardian ® Programmer Manual • Patient Manual for the AngelMed Guardian ® System • Product Information Manual for the AngelMed Guardian ® External Device (EXD) • St. Jude Medical Tendril® SDX Model 1488T/TC/K Endocardial Steroid-Eluting Active Fixation Pacing Leads User’s Manual 8 3 EXD Device Description 3.1 How Supplied The EXD is packaged with a neck cord and a belt case. Batteries are supplied separately. 3.2 Appearance Front – The front of the EXD contains the emergency and “see doctor” LEDs, and the “Press to Silence” button. The Emergency LED flashes red during alarms. The See Docto r LED flashes yellow during alerts. The Press to Silence button can be used to silence alarms and alerts and to check EXD battery power. Fig. 2 Front of EXD 9 Back – The back of the EXD c…

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Angel Medical Systems, Inc. Guardian ® IMD/EXD System for monitoring electrograms (EGMs), 402 MHz – 405 MHz FCC ID: THL- 000AG101 Photo One – External External Device (EXD) EXD Front Panel Angel Medical Systems, Inc. Guardian ® IMD/EXD System for monitoring electrograms (EGMs), 402 MHz – 405 MHz FCC ID: THL- 000AG101 Photo Two – External External Device (EXD) EXD Back Panel Angel Medical Systems, Inc. Guardian ® IMD/EXD System for monitoring electrograms (EGMs), 402 MHz – 405 MHz FCC ID: THL- 000AG101 Photo Three – External External Device (EXD) EXD Battery Compartment Angel Medical Systems, Inc. Guardian ® IMD/EXD System for monitoring electrograms (EGMs), 402 MHz – 405 MHz FCC ID: THL- 000AG101 Photo Four – External External Device (EXD) EXD Battery Compartment Showing FCC ID Label

AngelMed Guardian ® EXD Model EXD-001 For use with the AngelMed Guardian ® System. Contents: One EXD, One Belt Case, One Lanyard, Product Literature XXXXXX YYYY-MM -20°C/-4° F and +55°C/131°F Caution: Investigational Device. Limited by federal (or United States) law to investigational use. Manufactured for: Angel Medical Systems, Inc. 1 Sheila Drive FCC ID: THL-000AG101 Tinton Falls, NJ 07724 USA Phone: 800-763-5099 (USA) 0203-2100-002-A1 Rev B AngelMed Guardian ® EXD Model # EXD-001 XXXXXX 0203-2100-002-A1 Rev B

Angel Medical Systems, Inc. Guardian ® IMD/EXD System for monitoring electrograms (EGMs), 402 MHz – 405 MHz FCC ID: THL- 000AG101 External Device (EXD) EXD Battery Compartment Angel Medical Systems, Inc. Guardian ® IMD/EXD System for monitoring electrograms (EGMs), 402 MHz – 405 MHz FCC ID: THL- 000AG101 External Device (EXD) EXD Battery Compartment Showing FCC ID Label

Angel Medical Systems, Inc. Guardian ® IMD/EXD System for monitoring electrograms (EGMs), 402 MHz – 405 MHz FCC ID: THL- 000AG101 Photo One – Internal External Device (EXD) PCB Top Side with PCB Antenna Angel Medical Systems, Inc. Guardian ® IMD/EXD System for monitoring electrograms (EGMs), 402 MHz – 405 MHz FCC ID: THL- 000AG101 Photo Two – Internal External Device (EXD) PCB Bottom Side with RF Section (Top Right in Photo)

L.S. Compliance, Inc. W66 N220 Commerce Court Cedarburg, WI 53012 262-375-4400 Fax: 262-375-4248 COMPLIANCE TESTING OF : EXD controller ( used in the AngelMed Guardian system) PREPARED FOR: Angel Medical Systems, Inc. 1 Sheila Drive Tinton Falls, NJ 07724 TEST REPORT NUMBER: 305321-exd Note: References to 40kHz testing are highlighted in yellow throughout this test report. TEST DATE(S): August, September, October, 2005 All results of this report relate only to the items that were tested. This report is not to be reproduced, except in full, without written approval of L. S. Compliance, Inc. L.S. Compliance, Inc. FCC ID # THL-000AG101 Page 2 of 19 Test Report Number: 305321 EXD Prepared For: Angel Medical Systems, Inc. Table of Contents Section Description Page Index 2 1 L. S. Compliance in Review 3 2 A2LA Certificate of Accreditation 4 3 Validation Letter-U.S. Competent Body for EMC Directive 89/336/EEC 5 4 Signature Page 6 5 Product and General Information 7 6 Product Description 7 7 Test Requirements 7 8 Summary of Test Report 8 9 Introduction 8 10 Purpose 8 11 Radiated Emissions Test 9-16 12 Bandwidth Measurements 47 CFR 95.633 17 13 Frequency Stability 47 CFR; 95.628e 18 Appendix A Test Equipment List 19 L.S. Compliance, Inc. FCC ID # THL-000AG101 Page 3 of 19 Test Report Number: 305321 EXD Prepared For: Angel Medical Systems, Inc. 1. L. S. Compliance In Review Brief Review of L.S. Compliance Accreditations and Listing’s As an EMC Testing Laboratory, our Accreditation and Assessments are recognized through the following: A2LA – American Association for Laboratory Accreditation Accreditation based on ISO/IEC 17025 : 1999 with Electrical (EMC) Scope of Accreditation A2LA Certificate Number: 1255.01 Federal Communications Commission (FCC) – USA Listing of 3 Meter Semi-Anechoic Chamber based on Title 47 CFR – Part 2.948 FCC Registration Number: 90756 Listing of 3 and 10 meter OATS based on Title 47CFR – Part 2.948 FCC Registration Number: 90757 Industry Canada On file, 3 Meter Semi-Anechoic Chamber based on RSS-212 – Issue 1 File Number: IC 3088-A On file, 3 and 10 Meter OATS based on RSS-212 – Issue 1 File Number: IC 3088 U. S. Conformity Assessment Body (CAB) Validation Validated by the European Commission as a U. S. Competent Body operating under the U. S. /EU, Mutual Recognition Agreement (MRA) operating under the European Union Electromagnetic Compatibility –Council Directive 89/336/EEC, Article 10.2. Date of Validation: January 16, 2001 Validated by the European Commission as a U.S. Notified Body operating under the U.S./EU, Mutual Recognition Agreement (MRA) operating under the European Union Telecommunication Equipment – Council Directive 99/5/EC, Annex V. Date of Validation: November 20, 2002 Notified Body Identification Number: 1243 L.S. Compliance, Inc. FCC ID # THL-000AG101 Page 4 of 19 Test Report Number: 305321 EXD Prepared For: Angel Medical Systems, Inc. 2. A2LA Certificate of Accreditation L.S. Compliance, Inc. FCC ID # THL-000AG101 Page 5 of 19 Test Report Number: 305321 EXD Prepared For: Angel Medical Systems, Inc. 3. Validation Letter – U.S. Competent Body for EMC Directive 89/336/EEC L.S. Compliance, Inc. FCC ID # THL-000AG101 Page 6 of 19 Test Report Number: 305321 EXD Prepared For: Angel Medical Systems, Inc. 4. Signature Page Prepared By: November 1, 2005 Teresa A. White, Document Coordinator Date Tested and Approved By November 1, 2005 Kenneth L. Boston, EMC Lab Manager Date PE #31926 Licensed Professional Engineer Registered in the State of Wisconsin, United States L.S. Compliance, Inc. FCC ID # THL-000AG101 Page 7 of 19 Test Report Number: 305321 EXD Prepared For: Angel Medical Systems, Inc. 5. Product and General Information Manufacturer: Angel Medical Systems, Inc. Model No.: EXD Serial No.: 57, 58 Description: 405 MHz MICS band transceiver. 6. Product Description The AngelMed Guardian External Device (EXD) is a hand held telemetry Device that warns the patient of alarms and alerts via beeps and a red or yellow flashing LED, and is used to silence alarms and alerts. The EXD is also used for communication between a laptop (serving as a programmer) and the IMD, using a low power, low frequency pulsed signal that communicates to the IMD in the near field. The Guardian System monitors and detects changes in patients’ electrograms, using baseline electrograms from the previous day for comparison. 7. Test Requirements The above mentioned tests were performed in order to determine the compliance of the EUT system with limits contained in various provisions of Title 47 CFR, FCC Part 95, including: 95.628 95.631 95.633 95.635 95.639 plus 15.209 All radiated emissions tests were performed to measure the emissions in the frequency bands described by the above sections, and to determine whether said emissions are below the limits established by the above sections. These tests were performed in accordance with the procedure described in the American National Standard for methods of measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz (ANSI C63.4-2001). Another document used as reference for the EMI receiver specification was the International Special Committee on Radio Interference CISPR 16-1 (2003). L.S. Compliance, Inc. FCC ID # THL-000AG101 Page 8 of 19 Test Report Number: 305321 EXD Prepared For: Angel Medical Systems, Inc. 8. Summary of Test Report DECLARATION OF CONFORMITY The Angel Medical Systems EXD was found to MEET the requirements as described within the specification of Title 47 CFR FCC, Part 95 for a MICS band transceiver. The EXD was also found to MEET the 15.209 general limits for a 40 kHz transmitter. 9. Introduction During August, September and October of 2005, a series of Radiated Emission tests were performed on two samples of the EXD medical device, here forth referred to as the “Equipment Under Test” or “EUT”. The two models tested use the same RF transmitter topology (plus it is ide…

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Angel Medical Systems - EXD-Test Setup Photos Page 1 of 2 Photos Taken During Radiated Emission Testing Setup for the Radiated Emissions Test Vertical orientation Flat orientation Angel Medical Systems - EXD-Test Setup Photos Page 2 of 2 Side orientation All tests were performed according to Section 95.639 (f) (2) (i). Attached are additional pictures showing this set-up. The simulation liquid follows the recommendations per FCC 95.639 (f) (2) (ii) “Suitable Tissue Substitute Material per Bioelectromagnetics 8:29-36 (1987) Photo One showing Diameter to be +/- 30cm ( actual is 12inches x 2.54 = 30.48cm’s ) Blue platform supports the product during testing. Wall Thickness to be: +/- .635cm’s exactly. Photo Two showing Height to be +/- 76cm ( actual is 30 inches x 2.54 = 76.2cm’s ) Photo Three showing the Simulation Liquid per “Bioelectromagnetics” published article in 1987.