QRICM02-1Patient Device

Preliminary Manual for CardioMessenger FCC ID: QRICM02-1 BIOTRONIK GmbH & Co. 1 Contents What is Home Monitoring? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 About This Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 User group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Conventions used in this technical manual . . . 4 The CardioMessenger Set and Its Components . . . . . . . . . . . . . . . 5 Safety Precautions – What Should I Watch Out For? . . . . . . . . . . . 6 Electronic Article Surveillance (EAS) Systems . 8 How Do I Use the CardioMessenger? . . . . . . . . . . . . . . . . . . . . . . . . 9 What must be done before using the Cardio- Messenger? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Where should I put the CardioMessenger? . . . 9 How do I plug in the CardioMessenger? . . . . .10 The CardioMessenger "traffic light" system . 10 Turning on the CardioMessenger . . . . . . . . . .11 Turning off the CardioMessenger . . . . . . . . . .12 Charging the CardioMessenger . . . . . . . . . . . .12 How do I know when the batteries are running low? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 How do I know that the CardioMessenger is receiving and transmitting implant data? . . . .13 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 13 Resetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 When Does My Implant Transmit Data? . . . . . . . . . . . . . . . . . . . . . 16 How Do I Take Care of the CardioMessenger? . . . . . . . . . . . . . . . 17 343 851/A 2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Technical Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . 21 Cardio Report . . . . . . . . . . . . . . . . . . . . . . . . . . 21 GSM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Home Monitoring . . . . . . . . . . . . . . . . . . . . . . .21 BIOTRONIK Service Center . . . . . . . . . . . . . . .21 SMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 US Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 FCC RF Exposure Requirements . . . . . . . . . . .23 Legal Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Electromagnetic compatibility . . . . . . . . . . . . . 25 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 General information . . . . . . . . . . . . . . . . . . . . .26 Permissible environmental conditions . . . . . .26 CardioMessenger remote unit . . . . . . . . . . . . . 26 CardioMessenger charging station . . . . . . . . .27 Rechargeable battery (integrated) . . . . . . . . . .27 Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . .27 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 3 What is Home Monitoring? What is Home Monitoring? Dear Patient. You have received a BIOTRONIK pacemaker or implantable cardioverter-defibrillator (ICD) with a Home Monitoring function. The Home Monitoring fea- ture provides your attending physician with messages recorded by your implant at regular intervals, giving him or her information about your heart’s status. Your implant has a small wireless transmitter. Your patient device, which we will call the Cardio- Messenger, receives the implant messages and transmits them to the BIOTRONIK Service Center. The data are processed there and can be viewed only by your physician via fax and on the Internet (when avail- able) in the form of a comprehensive report called a Cardio report. Your doctor can use these data to decide whether your implant settings need to be updated or if your therapy plan needs to be changed. If necessary, your physician will contact you about making an appointment for a follow-up examination. For Home Monitoring to work, your implant must have the Home Monitoring function, and there must be cel- lular service in your area (GSM network). The power of the transmission in your implant is low so as not to impair your health in any way. Since the transmission range is so short (less than 2 meters, or 6 feet), you need to use the CardioMessenger to send the information to the BIOTRONIK Service Center. Note: If the CardioMessenger is not operational or is located too far from the implant to receive information (more than 6 feet), your implant still functions normally. Only the Home Monitoring function is inactive. Although the data recorded by the implant cannot be transmit- ted, they are saved so that your physician can evaluate them during your regularly scheduled follow-up examination. If you have any questions, please contact your physician. 4 About This Technical Manual About This Technical Manual User group The CardioMessenger is to be used by patients with a BIOTRONIK pacemaker or an implantable cardio- verter-defibrillator (ICD) with the Home Monitoring function. Conventions used in this technical manual Note: Provides additional information on the features of the CardioMessenger and how to operate it. Caution! If these instructions are not observed, minor injury or equipment damage may occur. WARNING! If these instructions are not observed, death, serious physical injury, or major equipment damage may result. 5 The CardioMessenger Set and Its Components The CardioMessenger Set and Its Components The BIOTRONIK CardioMessenger will not restrict your routine activities. The set comes equipped with the following components: — The CardioMessenger with rechargeable batteries — A charging station with a power supply unit and cable Accessories: — Belt clip 1) —Carrying strap 2) — Belt carrying case 3) The CardioMessenger wor…

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BIOTRONIKTelefon (+49 30) 689 05-0Geschäftsführer:Kommanditgesellschaft: Meß- und TherapiegeräteTelefax (+49 30) 689 05-655Dr. Max SchaldachHRA 6501, AG Berlin-Charlottenburg GmbH & Co.E-mail: [email protected] TroschelKomplementärin: BIOTRONIK GmbH Woermannkehre 1www.biotronik.deDr. Lothar KringsHRB 2918, AG Berlin-Charlottenburg D-12359 BerlinDr. Werner Braun BIOTRONIK GmbH & Co. • Postfach 47 02 55 • 12311 Berlin, Germany Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Berlin, 29.01.03 Re: Request For Confidentiality %,27521,.*PE+ &R )&&,' 45,&0 )&&&HUWLILFDWLRQ Gentlemen, In accordance with 0.459 of CFR 47, BIOTRONIK GmbH & Co. hereby requests confidentiality of all ∑ Block Diagramms:telex2_BlkDia, AC-EX04_BlkDia ∑ Schematicstelex2_Schem, AC-EX05_schem ∑ Internal Photostelex2_IntPho ∑ Operational Descriptiontelex2_OpDes, AC-EX12_OpDes ∑ Part Liststelex2_PartsLst included as attachments for the subject application. These documents contain detailed system and equipment description and related information about the product which BIOTRONIK GmbH & Co. considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, BIOTRONIK GmbH & Co. considers that this information would be of benefit to its competitors and that the disclosure of the infor- mation in these documents would give competitors an unfair advantage in the market. Sincerely Dr. Sven Bode Product Manager BIOTRONIK GmbH & Co.

BIOTRONIKTelefon (+49 30) 689 05-0Geschäftsführer:Kommanditgesellschaft: Meß- und TherapiegeräteTelefax (+49 30) 689 05-655Dr. Max SchaldachHRA 6501, AG Berlin-Charlottenburg GmbH & Co.E-mail: [email protected] TroschelKomplementärin: BIOTRONIK GmbH Woermannkehre 1www.biotronik.deDr. Lothar KringsHRB 2918, AG Berlin-Charlottenburg D-12359 BerlinDr. Werner Braun BIOTRONIK GmbH & Co. • Postfach 47 02 55 • 12311 Berlin, Germany Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Berlin, 29.01.03 Re: Declaration of the Non-Usage of the 900 MHz Band BIOTRONIK GmbH & Co. FCC ID: QRICM02-1 Dear Sirs, we declare, that our device QRICM02-1 will not use the 900 MHz GSM-band in the territories of the United States, although this device has in principle triband capabilities. Sincerely Dr. Sven Bode Product Manager BIOTRONIK GmbH & Co.

APPLICANT: MOTOROLAFCC ID: IHDT6AC1 Exhibit 13 June 1, 2000 CONFIDENTIALITY REQUEST CONTAINED WITHIN Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Application for PCS Transceiver Certification Gentlemen: Application: Motorola, Inc., Personal Communications Sector, 600 N. U.S. Highway 45, Libertyville, Illinois 60048-1286 herein submits: Application for Equipment Authorization (FCC Form 731-October 1992 with integrated Fee Processing Form, Fee Codes EFT and EBC), application fee in the amount of $610, and Exhibits; for Certification of a PCS Transceiver, FCC ID: IHDT6AC1. Motorola is also the manufacturer of this equipment. Confidentiality: Pursuant to Section 0.459 of the Commission's rules (CFR 47), Motorola requests confidentiality for portions of the material contained in this application and that the identified material be withheld from public inspection following the grant of this authorization. This material contains Motorola's trade secrets and confidential information that Motorola does not customarily release to the public and which is otherwise not generally available to the public. Confidentiality is requested for the following exhibits: • Exhibit 4 Block Diagrams • Exhibit 5 Schematics • Exhibit 12 Operational Description Description: This equipment is a GSM Embedded Module, which operates in the 1900 MHz PCS band. It can transfer data or voice over a GSM network. Model differences are dependent upon housing and external connector variations. Contact Information: Please contact me by telephone at (847) 523-6167 or by e-mail ([email protected]), if there are questions or additional information needed concerning this filing. Regards, Andrew J. Bachler FCC Liaison Personal Communications Sector 600 N. U.S. Highway 45 Libertyville, IL 60048-5343

Correspondence Summary Questions & Answers 02/18/2003 Applicant: Biotronik GmbH & Co. Equipment: Patient Device, CM02-1 FCC ID: QRICM02-1 Q-11: SAR: The FCC requires that the tissue parameters and probe calibration be done at 1900 and not 1800 for measurement in the 1900 PCS band. The probe conversion factor used is for 1800 MHz. Please, provide new measurements with a ConvF at 1900 MHz. A-11: Page 41 of the SAR test report : Conversation factor 1800 MHz is included in a transducer table with conversion factors with frequency range from 1700 MHz to 1910 MHz. Please find attached "conversion_factor.pdf". The measurement software Dasy 4 use in dependence of the registered (listed) frequency (Tx channel of the sample) the correct conversion factor out of the transducer table. Additional request: Q-1: SAR – 1900MHz Conversion factors: What is the conversion factor for 1900MHz based on the table with conversion factors with frequency range from 1700 MHz to 1910 MHz? Please justify and include an analysis of the expected variation on the SAR value. A-1 : SAR - 1900MHz Conversion factors: Please find attached calibration certificate from the company Schmid & Partner Engineering AG. There find you the modified certificate for the SN:1707 probe and numerically assessed conversion factor at 1900 MHz for body tissue. Bruno Clavier TIMCO ENGINEERING INC. 849 NW State Road 45 Newberry, Florida 32669 http://www.timcoengr.com 888.472.2424 F 352.472.2030 mailto:[email protected]

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 1 of 15 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 2 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 3 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 4 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 5 of 15

BIOTRONIKTelefon (+49 30) 689 05-0Geschäftsführer:Kommanditgesellschaft: Meß- und TherapiegeräteTelefax (+49 30) 689 05-655Dr. Max SchaldachHRA 6501, AG Berlin-Charlottenburg GmbH & Co.E-mail: [email protected] TroschelKomplementärin: BIOTRONIK GmbH Woermannkehre 1www.biotronik.deDr. Lothar KringsHRB 2918, AG Berlin-Charlottenburg D-12359 BerlinDr. Werner Braun BIOTRONIK GmbH & Co. • Postfach 47 02 55 • 12311 Berlin, Germany Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Berlin, 29.01.03 Re: Label Sample FCC ID: QRICM02-1

BIOTRONIKTelefon (+49 30) 689 05-0Geschäftsführer:Kommanditgesellschaft: Meß- und TherapiegeräteTelefax (+49 30) 689 05-655Dr. Max SchaldachHRA 6501, AG Berlin-Charlottenburg GmbH & Co.E-mail: [email protected] TroschelKomplementärin: BIOTRONIK GmbH Woermannkehre 1www.biotronik.deDr. Lothar KringsHRB 2918, AG Berlin-Charlottenburg D-12359 BerlinDr. Werner Braun BIOTRONIK GmbH & Co. • Postfach 47 02 55 • 12311 Berlin, Germany Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Berlin, 29.01.03 Re: Label Location Information FCC ID: QRICM02-1

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 6 of 15 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 7 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 8 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 9 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 10 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 11 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 12 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 13 of 15

APPLICANT: MOTOROLA, INC. FCC ID: IHDT6AC1 EXHIBIT 9 Typical Unit (Bottom View Shields Removed) Typical Unit (Top View Shields Removed) Note: External connector type varies depending upon model

Applicant: Biotronik GmbHQRI CM02-1 Operational Description The information in this exhibit is in accordance with requirements for certification as outlined in the FCC Rules and Regulations, 47 CFR Part 2; Sections 2.1033, 2.1046 - 2.1057, and Part 24, Sections 24.52, 24.235 and 24.238. General The device comprises a PCS datamodule (FCC ID: IHDT6AC1) and a 403.65 MHz receiver for Ultra Low Power Active Medical Implants (ULPAMI). The receiver is used to collect data from ULPAMI which is then coded appropriatly to be sent via PCS1900 using the PCS datamodule to a Service Center. Since the device uses a PCS module with Full Type Approval some measurements on parameters of the module not influenced by integrating the module into a device have been omitted. Instead it is referred to documents already filed with IHDT6AC1 certification. Certification Requirements Section 2.1033(c): Application for Certification (1) Name of Applicant: Biotronik GmbH, also maufacturer, for adress refer to form 731 (2) Identification of Equipment: QRI CM02-1 (3) Instruction Manual: Refer to telex2_UserMan.pdf (4) Types of Emissions: refer to IHDT6AC1 (5) Frequency Range: For PCS module refer to IHDT6AC1 For ULPAMI: Receiver operates on one 300 kHz channel with center at 403.65 MHz in MICS Band . (6) Range of operating power values: refer to IHDT6AC1 (7) Maximum Power rating: refer to IHDT6AC1 (8) The dc voltages applied to and dc currents into the Final Amplifying Device: Refer to IHDT6AC1. (9) Tune-Up Procedure There are no user accessible adjustments or tuning in this device. All necessary adjustments and tuning are performed during manufacture of the product. Any adjustments or tuning after service or repair are done as part of that process as special equipment is required to perform such adjustments. (10) Schematic Diagramm: refer to telex2_Schem.pdf For the PCS Module refer to IHDT6AC1 Applicant: Biotronik GmbHQRI CM02-1 Spurious supression and interference of high speed clocks into sensitive radio circiutry is achived by several means: 1. Sources of spurious radiation such as frequency source circuitry and high gain circuitry within the equipment are assembled under grounded conductive shields forming a localized shielded enclosure within the unit. 2. Physical separation of frequency sources from high gain circuitry. 3. Multilayer PC boards allow use of stripline and shielded traces for routing signals. (11) Label requirement: refer to telex2_LabelSmpl.pdf and telex2_LabelLoc.pdf (12) Photograph: refer to telex2_ExtPho.pdf and telex2_IntPho.pdf (13) Modulation: refer to IHDT6AC1 (14) Data Required by 2.1046 - 2.1057 Inclusive Section 2.1046: RF Power Output - Refer to IHDT6AC1 Section 2.1047: Modulation Characteristics: refer to IHDT6AC1 Section 2.1049: Occupied Bandwidth: refer to IHDT6AC1 Section 2.1051: Conducted Spurious Emissions: refer to IHDT6AC1 Section 2.1053: Radiated Spurious Emissions: refer to GOM20211-7350-T47 Section 2.1055: Frequency Stability refer to IHDT6AC1

APPLICANT: MOTOROLA, INC.FCC ID: IHDT6AC1 EXHIBIT 10 TRANSCEIVER ADJUSTMENTS/TUNE-UP PROCEDURE There are no user accessible adjustments or tuning in this portable cellular transceiver. All necessary adjustments and tuning are performed during manufacture of the product. Any adjustments or tuning after service or repair are done as part of that process as special equipment is required to perform such adjustments.

ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH TEST - REPORT FCC RULES PART 15 / SUBPART B Test report no.: G0M20211-7350-E-18 FCC ELECTRONIC TECHNOLOGY SYSTEMSSTORKOWER STRASSE 38C,D-15526 REICHENWALDE B. BERLIN DR. GENZ GMBHPHONE +49-33631-888 00FAX +49-33631-888 660 Registration Number : G0M20211-7350-E-18 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STRASSE 38C D-15526 REICHENWALDE B. BERLIN Page 1 of 24 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH TABLE OF CONTENTS 1General Information2 1.1 Notes2 1.2 Tester4 1.3 Testing laboratory5 1.3.1 Location5 1.3.2 Details of accreditation status5 1.3.3 Test location, where different from ETS5 1.4 Details of applicant6 1.5 Application details6 1.6 Test item6 1.6.1 Description of test item6 1.6.2 Manufacturer (if different from applicant in point 1.4)7 1.6.3 Frequency behaviour7 1.7 Test standards7 2Technical test8 2.1 Summary of test results8 2.2 Test environment8 2.3 Test equipment utilized10 2.4 Test results19 2.4.1 Conducted Emission20 2.4.2 Spurious Emission21 2.5 Test protocols22 3 Normative references24 Annex : Pictures and diagrams Registration Number : G0M20211-7350-E-18 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STRASSE 38C D-15526 REICHENWALDE B. BERLIN Page 2 of 24 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1 General Information 1.1 Notes The purpose of conformity testing is to increase the probability of adherence to the essential requirements or conformity specifications, as appropriate. The tests were carried out and passed in accordance with the standards: FCC part 15:August 2002 The complexity of the technical specifications, however, means that full and thorough testing is impractical for both technical and economic reasons. Furthermore, there is no guarantee that a test sample which has Passed all the relevant tests conforms to a specification (only telecommunication products). Neither is there any guarantee that such a test sample will interwork with other genuinely open systems. The existence of the tests nevertheless provides the confidence that the test sample possesses the qualities as maintained and that its performance generally conforms to representative cases of communications equipment. The test results of this test report relate exclusively to the item tested as specified in 1.6. The test report may only be reproduced or published in full. Reproduction or publication of extracts from the report requires the prior written approval of the ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH. Registration Number : G0M20211-7350-E-18 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STRASSE 38C D-15526 REICHENWALDE B. BERLIN Page 3 of 24 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH Important Notes: Proper labeling is required for each device. Devices shall be labeled in accordance with labeling requirements pursuant to section 15.19 and section 2.1074 of the FCC rules. Devices subject to a Declaration of Conformity shall be uniquely identified by the responsible party. This identification shall not be of a format which could be confused with the FCC Identifier required on certified, notified type accepted or type approved equipment. The responsible party shall maintain adequate identification records to facilitate positive identification for each device. The user manual or instruction manual shall included also a warning statement that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Reference Section 15.21 Furthermore an information to the user regarding to the interference potential of the device and about simple measures that can be taken to correct interference is required. Reference Section 15.105 The responsible party must warrant that each unit of equipment marketed under a Declaration of Conformity is identical to the unit tested and found acceptable with the standards and that the records maintained by the responsible party continue to reflect the equipment being produced under the Declaration of Conformity within the variation that can be expected due to quantity production and testing on a statistical basis. Registration Number : G0M20211-7350-E-18 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STRASSE 38C D-15526 REICHENWALDE B. BERLIN Page 4 of 24 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.2 Tester 11.12.2002 ___________________________________________________________________ DateETS-Lab.Test EngineerSignature Technical responsibility for area of testing: 11.12.2002N. Kaspar ____________________________________________________________________ DateETSNameSignature Registration Number : G0M20211-7350-E-18 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STRASSE 38C D-15526 REICHENWALDE B. BERLIN Page 5 of 24 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.3 Testing laboratory 1.3.1 Location ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH (ETS) Storkower Strasse 38c D- 15526 Reichenwalde Germany Telephone :+ 49 33631 888 000 Telefax:+ 49 33631 888 660 1.3.2 Details of accreditation status A CCREDITED TESTING LABORATORY DAR-REGISTRATION NUMBER: TTI-P-G 126/96 A CCREDITED COMPETENT BODY DAR-REGISTRATION NUMBER: BPT-ZE-026/96 FCC filed test laboratoryReg. No. 96970 Bluetooth Qualification Test Facility /BQTF) Accredited by Bluetooth Qualification Review Board Industry Canada filed test laboratory Reg. No. IC 3470 A2LA AccreditedCertification number 1983-01 1.3.3 Test location, where different from ETS Name:./. Street:./. Town:./. Country:./. Telephone:./. Fax:./. Teletex:./. Registration Number : G0M20211-7350-E-18 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STRASSE 38C D-15526 REICHENWALDE B. BERLIN Page 6 of 24 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.4 Details of applicant Name: Biotronik GmbH & Co Street: Woermannskehre 1 Town: 12359 Berlin Country: Germany Telephone: 030/68905147 Fax: 030/68905343 Teletex: ./. Contact: Herr Wolfgang Buske Telephone: 030/68905147 1.5 Application detai…

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Z-axis scan at max. SAR location Test Laboratory: ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH DUT: PMS, Telex2 Type & Serial Number: none Program: GSM1900 body; GSM1900 body 512 back belt clip Communication System: GSM 1900; Frequency: 1850.2 MHz; Duty Cycle: 1:8 Medium: Muscle 1900 MHz ( ó = 1.51 mho/m, å = 51.23, ñ = 1000 kg/m3) Phantom section: FlatSection DASY4 Configuration: - Probe: ET3DV6 - SN1707; ConvF(5, 5, 5); Calibrated: - Sensor-Surface: 4mm (Mechanical Surface Detection) - Electronics: DAE3 Sn522; Calibrated: 9/11/2002 - Phantom: - TP: - Software: DASY4, V4.0 Build 51 Area Scan (81x171x1): Measurement grid: dx=10mm, dy=10mm Zoom Scan (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm Reference Value = 18.3 V/m Peak SAR = 0.667 mW/g SAR(1 g) = 0.442 mW/g; SAR(10 g) = 0.285 mW/g Power Drift = 0.007 dB 0.00 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 0.005 0.010 0.015 0.020 0.025 0.030 0.035 Averaged SAR SAR, Value Along Z, X=3, Y=3 mW /g m

Page 1 of 2November 20, 2002 Additional Conversion Factors for Dosimetric E-Field Probe Type: Serial Number: Place of Assessment: Date of Assessment: Probe Calibration Date: Schmid & Partner Engineering AG hereby certifies that conversion factor(s) of this probe have been evaluated on the date indicated above. The assessment was performed using the FDTD numerical code SEMCAD of Schmid & Partner Engineering AG. The evaluation is coupled with measured conversion factors. The uncertainty of the numerical assessment is based on the extrapolation from measured value at 900 MHz or at 1800 MHz. Assessed by: ET3DV6 1707 Zurich November 20, 2002 September 3, 2002 Page 2 of 2November 20, 2002 Dosimetric E-Field Probe ET3DV6 SN:1707 Conversion factor (± standard deviation) 1700-1910 MHzConvF5.0 ± 8% e r = 53.3 ± 5% s = 1.52 ± 5% mho/m (body tissue)

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 14 of 15 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH REGISTRATION NUMBER: G0M20211-7350-T-47 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH STORKOWER STR. 38C, D-15526 REICHENWALDE B. BERLIN Appendix Page 15 of 15