THL-IMDAMSG3AngelMed Guardian

ngel Medical Systems ® 1163 Shrewsbury Ave., Suite E Shrewsbury, NJ 07702 (USA) +1 561 962-2191 www.angel-med.com AngelMed Guardian ® Implantable Medical Device (IMD) Model AMSG3 User’s Guide January 2013 P/N 0212-2100-036#P15 Rev A Fold Line Caution - Investigational device. Limited by United States law to investigational use. AngelMed, AngelMed Guardian, and Angel Medical Systems are trademarks or registered trademarks of Angel Medical Systems, Inc. The AngelMed Guardian system is protected by U.S. patents. For more information, please see the Help/About page on the AngelMed Guardian Programmer. © 2005-2013 Angel Medical Systems, Inc., All Rights Reserved IMD User’s Manual i Contents 1 Introduction 1 Available Literature 1 2 System Overview 2 System Components 2 Indications & Contraindications 3 3 IMD Device Description 4 Data Acquisition, Characterization, and Storage 4 Vibration Patterns 7 Wireless Telemetry 7 Radiopaque Identifier 8 Certifications 9 4 Storage, Handling, and Resterilization 11 5 Precautions 13 General 13 Potential Adverse Effects 14 Medical Therapy Precautions 16 Electromagnetic Interference Precautions 18 Physical Activity Precautions 20 6 Implant and Setup Procedures 21 7 Patient Follow-up 34 Follow-up Frequency 34 Follow-up Tasks 34 Contents ii IMD User’s Manual 8 Explant Procedure 35 Explanting the IMD 36 9 Service and Support 44 Service 44 Technical Support 44 10 IMD Specifications 45 11 Programmable Parameters: Defaults and Ranges 48 Index 53 IMD User’s Manual 1 1 Introduction The AngelMed Guardian ® Implantable Medical Device (IMD) is an implantable programmable device that monitors the patient’s electrogram, vibrates to warn the patient of alarms and alerts, and stores electrogram signals and other data. The IMD is one of the primary components of the AngelMed Guardian system. How supplied – The IMD is supplied in a sterile tray for introduction into the operating field. The tray contains one IMD and a torque wrench. The outer box contains literature. About this manual – This document describes the IMD and provides implantation procedures, as well as an outline of the Pre-Implant Check and Post-Implant Setup procedures. For detailed information on these procedures using the Programmer, see the AngelMed Guardian Programmer Application User’s Manual. Available Literature The following documents provide information relevant to the AngelMed Guardian System.  AngelMed Guardian ® External Device (EXD) Model EXD-001 User’s Manual  AngelMed Guardian ® Programmer Application User’s Manual  Patient Manual for the AngelMed Guardian ® System  User’s Manual or Instructions for Use of the Angel Medical Systems-supplied pacing lead 2 IMD User’s Manual 2 System Overview The AngelMed Guardian system monitors and 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 where the patient immediately calls for an ambulance  See Doctor alerts, for less-significant events where the patient makes an appointment to see the doctor in the next 1 or 2 days System Components The AngelMed Guardian system consists of the IMD plus the following components: Lead – an Angel Medical Systems-supplied IS-1, currently-marketed, active fixation, steroid eluding pacing lead that attaches to the apex of the right ventricle. External Device (EXD) – a hand-held telemetry device that provides alarms and alerts via beeps and a red or yellow flashing indicator light, and is used to silence alarms and alerts. The EXD is also used for communication between the Programmer and the IMD. 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. The IMD is programmed with either of the following Programmers:  AngelMed Guardian Model Prog-002 Programmer running software version 3.6 or higher.  AngelMed Guardian Model Prog-003 Programmer running software version 3.6 or higher. System Overview IMD User’s Manual 3 This booklet summarizes some of the tasks that can be performed with the Programmer. For detailed information on Programmer- related tasks, see the AngelMed Guardian Programmer Application User’s Manual. You may also consult the Programmer online Help. Indications & Contraindications Indications: The AngelMed Guardian system is an implantable cardiac event recorder with ST segment measurement and alarms. It is indicated for use when the clinician decides to monitor for ST segment deviations on a continuous basis. The AngelMed Guardian system signals a visible, audible, and vibrotactile alarm to the patient if it detects electrogram parameters that are preset by the clinician. It also records events matching electrogram parameters preset by the clinician for later analysis by the clinician. Note: The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes needs to be determined by a clinician. Contraindications: Do not implant the IMD in:  Patients who have previously been implanted with a pacemaker or cardioverter-defibrillator. The AngelMed Guardian system is not designed to monitor electrograms in the presence of pacing signals generated by these devices.  Patients who cannot feel the IMD vibration when the IMD is placed on top of the skin and just under the left clavicle. See Precautions on page 13 for additional considerations regarding IMD implantation and operation. 4 IMD User’s Manual 3 IMD Device Description The IMD serves two fundamental functions:  To detect an ST shift – in other words, a change in the ST deviation of a patient’s electrogram 1  If an ST shift occurs, to warn the patient to seek immediate medical help, by vibrating in a…

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W66 N220 Commerce Court, Cedarburg, Wisconsin 53012-2636 BUS 262.375.4400 FAX 262.375.4248 www.lsr.com Date: December 28, 2012 Re: FCC ID: THL‐IMDAMSG3 Applicant: Angel Medical Systems, Inc. Correspondence Reference Number: 43103 Form 731 Confirmation Number: EA215127 Response Letter To Diane Poole: Thank you for the review and comments. Based on the referenced KDB publication (447498) section 4.2.4 it appears that SAR test exclusion may be applied. We believe that the submitted SAR analysis exceeds* the requirements of the optional exclusion and should be accepted as proof of SAR compliance. *The reported SAR analysis levels are significantly lower than the SAR limits as well as the submitted test report indicating the maximum power when measured in a radiated fashion much lower than 1.0 mW. Sincerely, Thomas T. Smith Manager of EMC Test Services

EXTERNAL PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Page 1 of 3 EXTERNAL PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Page 2 of 3 EXTERNAL PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Page 3 of 3

42 TOLERANCES ARE: 53 B TOLERANCES ARE: D A SCALE Form No. 1702-001-T7, Rev. A DRAWN ~ REVEAL IT TO UNAUTHORIZED 8765 3 4 1 2 REV SIZE DOCUMENT No. DC B A B DRAWING, ASSY., IMD AMSG3, MEDICAL SYSTEMS WITHOUT FINAL SHIPPING - P15 SHEET TITLE PERSONS OR SEND IT OUTSIDE ANGEL CONFIDENTIAL DATE ANGLES .XX +/- .XX DECIMALS +/- ~ .XXX +/- .XXX +/- ~ DIMENSIONS ARE IN INCHES FRACTIONS UNLESS OTHERWISE SPECIFIED 1 OF 1 876 C 21 53 B 4 C A SCALE Form No. 1702-001-T7, Rev. A DRAWN JDF ~ 8 D 65 A 0212-1200-003-D1#P15 B 3 4 1 A 1 6 7 8 1 OF 1 2 REV SIZE 5/15/12 7 D DOCUMENT No. C B SHEET TITLE DATE A WRITTEN AUTHORIZATION. CONFIDENTIAL ANGLES .XX +/- .XX DECIMALS +/- ~ .XXX +/- .XXX +/- ~ DIMENSIONS ARE IN INCHES FRACTIONS UNLESS OTHERWISE SPECIFIED THIS DOCUMENT IS THE PROPERTY OF ANGEL MEDICAL SYSTEMS, INC. AND MUST BE ACCOUNTED FOR. INFORMATION HEREIN IS CONSIDERED CONFIDENTIAL. DO NOT REPRODUCE IT, 1163 Shrewsbury Ave.Suite EShrewsbury, NJ 07702(732) 542-5551 LABEL CONFIGURATION 1 5d 5b 5d 1 2 5c 0212-2100-020#P15 5a FIGURE 2 FIGURE 1 TWO PIECE BOX WITH INSERT - P15 QTY PART NUMBER DESCRIPTION ITEM NO. PARTS LIST 1 0202-2100-017 PART SPEC., BAG, POLYETHYLENE 6 1 0212-2100-035#P15 or 0212-2100-035-Cx#P15 (See Note #5) IMD LABEL SET - P15 (ENGLISH) orIMD LABEL SET - P15 (OTHER LANGUAGES) 5 1 0201-2100-006#P05 or 0201-2100-006-Cx#P05 (See Note #5) PART SPEC, PATIENT IMD CARD - P05 (ENGLISH) orPART SPEC, PATIENT IMD CARD - P05 (OTHER LANGUAGES) 4 1 0212-2100-032#P15 PART SPEC., IMD AMSG3, SEALED IN STERILE PACK - P15 3 1 0212-2100-036#P15 or 0212-2100-036-Cx#P15 (See Note #5) IMD USERS MANUAL - P15 (ENGLISH) or IMD USERS MANUAL - P15 (OTHER LANGUAGES) REVISIONS REV. DESCRIPTION A ORIGINAL ISSUE NOTES: Unit is sterile. Use care when handling unit not to pull or puncture lid. 1. Item #3 is comprised of sterilized Tyvek pack, bag, and box (top, bottom, and 2. insert).English language specific labeling and part specs shown in models are for 3. reference only.For Parts list items #2, 4, & 5, DO NOT MIX LANGUAGES. These parts should all 4. be the same language (English or other language).In Part Number, x = appropriate non-English language designation.This drawing is not complete with out AMS Process Spec. #0212-1200-003#P15. 5. 5b 3 2 5a 1 BOX TOP 6 DIRECTION PACKSTERILE 4 BOX BOTTOM/ 1 OF TEXT INSERT NOTE 5c NOTEDIRECTIONOF TEXTNOTEDIRECTIONOF TEXT This drawing and associated models, assemblies, and details are maintained in the SolidWorks Workgroup PDM Vault. A PDF version of this drawing is available for review and is maintained in the Grand Avenue System as per AMS doc #1702-001 (Do cument Control Procedure).

AngelMed Guardian ® IMD Model AMSG3 Implantable Medical Device (IMD) for detecting and warning a patient of a variety of changes in his or her electrogram. For use ONLY with an Angel Medical Systems-supplied pacing lead. Contents: One IMD, One Torque Wrench, Product Literature, Chart Labels, Patient Information Card The contents (STERILE) of the inner package have been sterilized by ethylene- oxide gas. Sterility cannot be guaranteed if sterile package is damaged or opened. «ManDate» «ExDate» «SerialNum» -10°C/14°F and +55°C/131°F Caution: Investigational Device. Limited by United States law to investigational use. Proposition 65, a State of California voter initiative, requires the following notice: WARNING: This product and its packaging have been sterilized with ethylene oxide. This packaging may expose you to ethylene oxide, a chemical known to the state of California to cause cancer or birth defects or other reproductive harm. Manufactured for: Angel Medical Systems, Inc. 1163 Shrewsbury Ave., Suite E FCC ID: THL-IMDAMSG3 Shrewsbury, NJ 07702 USA Phone: (561) 962-2191 (800) 508-5206 (USA only) 0212-2100-035#P15 Rev A AngelMed Guardian ® IMD Model AMSG3 «SerialNum» «ExDate» 0P/N 0212-2100-001#P15 Rev A 0212-2100-035#P15 Rev A AngelMed Guardian ® IMD Model AMSG3 Implantable Medical Device (IMD) for detecting and warning a patient of a variety of changes in his or her electrogram. For use ONLY with an Angel Medical Systems-supplied pacing lead. Contents: One IMD, One Torque Wrench The contents (STERILE) of this inner package have been sterilized by ethylene- oxide gas. Sterility cannot be guaranteed if sterile package is damaged or opened. «ManDate» «ExDate» «SerialNum» -10°C/14° F and +55°C/131°F Caution: Investigational Device. Limited by United States law to investigational use. Manufactured for: Angel Medical Systems, Inc. FCC ID: THL-IMDAMSG3 1163 Shrewsbury Ave., Suite E Shrewsbury, NJ 07702 USA Phone: (561) 962-2191 (800) 508-5206 (USA only) 0212-2100-035#P15 Rev A AngelMed Guardian ® IMD «SerialNum» AMSG3 AngelMed Guardian ® IMD «SerialNum» AMSG3 AngelMed Guardian ® IMD «SerialNum» AMSG3 AngelMed Guardian ® IMD «SerialNum» AMSG3 AngelMed Guardian ® IMD «SerialNum» AMSG3 AngelMed Guardian ® IMD «SerialNum» AMSG3 AngelMed Guardian ® IMD «SerialNum» AMSG3 AngelMed Guardian ® IMD «SerialNum» AMSG3 0212-2100-035#P15 Rev A

INTERNAL PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Page 1 of 2 INTERNAL PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Page 2 of 2

W66 N220 Commerce Court ● Cedarburg, WI 53012 USA ● Phone: 262.375.4400 ● Fax: 262.375.4248 ● www.lsr.com Prepared For: Angel Medical Systems Name: IMD Report: TR 312257 FCCTX V1 Model: AMSG3 LSR: C-1570 Serial: JH3000294 Page 1 of 20 i. Title Page ENGINEERING TEST REPORT # 312257 LSR Job #: C-1570 Compliance Testing of: IMD Test Date(s): October 2012 Prepared For: Angel Medical Systems Attn: Tom Picciotti 1163 Shrewsbury Ave Suite E Shrewsbury, NJ 07702 This Test Report is issued under the Authority of: Adam Alger, EMC Engineer Signature: Date: 11-7-12 Test Report Reviewed by: Shane Rismeyer, EMC Engineer Signature: Date: 11-6-12 Report by: Adam Alger, EMC Engineer Signature: Date: 10-29-12 This Test Report may not be reproduced, except in full, without written approval of LS Research, LLC. Prepared For: Angel Medical Systems Name: IMD Report: TR 312257 FCCTX V1 Model: AMSG3 LSR: C-1570 Serial: JH3000294 Page 2 of 20 ii. Table of Contents Table of Contents i. Title Page ................................................................................................................................... 1 ii. Table of Contents ....................................................................................................................... 2 iii. LS Research, LLC ...................................................................................................................... 3 1.0 Summary of Test Report ............................................................................................................ 4 2.0 Test Facilities ............................................................................................................................. 4 3.0 Client Information ...................................................................................................................... 5 3.1 Equipment Under Test (EUT) Information ................................................................................ 5 3.2 Product Description ................................................................................................................... 5 3.3 Modifications Incorporated In the EUT for Compliance Purposes ........................................... 6 4.0 Conditions of Test ...................................................................................................................... 6 5.0 Additional Information .............................................................................................................. 7 6.0 Test Equipment .......................................................................................................................... 7 7.0 Conformance Summary ............................................................................................................. 8 Appendix A – Test Equipment ............................................................................................................. 9 Appendix B – Test Data ...................................................................................................................... 10 B.1 – Radiated Emissions ............................................................................................................... 10 Appendix C - Uncertainty Summary .................................................................................................. 18 Appendix D - References .................................................................................................................... 19 Prepared For: Angel Medical Systems Report: TR 312257 FCCTX V1 LSR: C-1570 iii. LS Research, LLC 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: 2005 A2LA Certificate Number: 1255.01 Federal Communications Commission (FCC) Listing of 3 Meter Semi-Anechoic Chamber based on Title 47 CFR FCC Registration Number: 90756 Industry Canada On file, 3 Meter Semi- Anechoic Chamber based on RSS File Number: IC 3088-A On file, 3 and 10 Meter OATS based on RSS File Number: IC 3088 U. S. Conformity Assessment Body 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 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 Date of Validation: November 20, 2002 Notified Body Identification Number: 1243 Name: IMD Model: AMSG3 Serial: JH3000294 Page 3 of 20 LS Research, LLC in Review As an EMC Testing Laboratory, our Accreditation and Assessments are recognized through the American Association for Laboratory Accreditation Accreditation based on ISO/IEC 17025: 2005 with Electrical (EMC) Scope of A2LA Certificate Number: 1255.01 Federal Communications Commission (FCC) – USA Anechoic Chamber based on Title 47 CFR – Part 2.948 gistration Number: 90756 Anechoic Chamber based on RSS-212 – Issue 1 On file, 3 and 10 Meter OATS based on RSS-212 – Issue 1 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 2004/108/EC (formerly 89/33 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 As an EMC Testing Laboratory, our Accreditation and Assessments are recognized through the with Electrical (EMC) Scope of Accreditation Part 2.948 Validated by the Europ…

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TEST SETUP PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Radiated Emissions TEST SETUP PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Radiated Emissions Flat Orientation TEST SETUP PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Radiated Emissions Horizontal Orientation TEST SETUP PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Radiated Emissions Vertical Orientation TEST SETUP PHOTOS Company Name Angel Medical Systems, Inc Model # AMSG3 FCC ID # THL‐IMDAMSG3 Frequency Stability in Temperature Chamber