QRICMSMARTCardioMessenger Smart 3G

CardioMessenger ® Smart Transmitter for BIOTRONIK Home Monitoring ® Technical Manual Doc. Id.: tbd_A Index 399229_ATechnical ManualCardioMessenger ® Smart 2 3 Table of Contents Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 First Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Check the completeness of the delivery. . . . . . . . . . . . . . . . . 5 Where Do I Put the CardioMessenger? . . . . . . . . . . . . . . . . . 6 How Do I Connect the CardioMessenger? . . . . . . . . . . . . . . . 7 How Do I Use the CardioMessenger? . . . . . . . . . . . . . . . . . . . 7 How Do I Turn Off the CardioMessenger? . . . . . . . . . . . . . . . 8 Icons on the CardioMessenger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Call back function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Error Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Error type A: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Error type B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Error type C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Precautionary Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 4Introduction 1Introduction Introduction1399229_ATechnical ManualCardioMessenger ® Smart Dear Patient: You have received a device with the additional Home Monitoring function by BIOTRONIK. How Home Monitoring works Your device (1) is equipped with a special transmitter. It sends information on your heart to the transmitter, your CardioMessenger (2), usually at night. The transmission power from your device is low and does not impair your health in any way. Its limited transmission range, however, requires the use of the Cardi- oMessenger. The CardioMessenger collects the information and transmits it to the BIOTRONIK Service Center (4) as encoded messages via a mobile connection (3). Here, the messages are decoded and can be viewed by your physician (5) on a protected web site. Based on the information received, your physician can decide if your device is opti- mally programmed or if the therapy needs adjustments. In this way, Home Moni- toring serves as a practical diagnostic aid for your physician. 5First Steps 2First Steps First Steps2399229_ATechnical ManualCardioMessenger ® Smart Check the completeness of the delivery Your CardioMessenger is supplied ready for use, and you can operate it immediately by inserting the power plug into the wall outlet. However, prior to usage, check the CardioMessenger for any visible damage and use only an undamaged CardioMessenger. Return a damaged CardioMessenger to your physician. Use only the provided original power supply brick (see the technical data). Other equipment may impair proper functioning of the CardioMessenger and increase the emitted interference or decrease the CardioMessenger's resistance to interference. The delivery includes the following: The CardioMessenger Smart The power supply brick with power cord and power plug Technical manual with quick reference guide 6First Steps Where Do I Put the CardioMessenger? Your CardioMessenger has a battery so you can take it along as needed during the day. However, it should be placed close to your bed at night for the nightly data transfer from the device to the CardioMessenger. The bedside table is therefore the best location for your CardioMessenger, as it usually meets the following conditions: •The CardioMessenger is placed on a solid base and cannot fall. •The distance to the device is less than 2 m (6 feet), so that regular data trans- mission from the device to the CardioMessenger at night is assured. •On the bedside table, the icons on the CardioMessenger's display can be read well so you can verify on a daily basis that it is ready for service. However, if the bedside table is made of metal, you should not place the CardioMessenger directly on the table. For example, place a stack of books to establish a distance of approx. 5 cm between the two so that the metal does not interfere with the device's data reception. Please take the following also into consideration: •Do not place the CardioMessenger next to a television set, microwave oven, or a similar source of electromagnetic interference. You may hear noises typical of cellular phones if you place the CardioMessenger too close to a radio alarm or a television set, for example. •Do not expose the CardioMessenger to temperatures exceeding 40°C (104°F). Do not put it in places where it is subjected to direct sunlight and do not put it directly under a halogen spotlight. •Do not expose the CardioMessenger to temperatures below 0 C (32 F). •Protect the CardioMessenger against water and high humidity. Do not place it in the bathroom. 7First Steps How Do I Connect the CardioMessenger? Your CardioMessenge…

Text truncated - open the document above for the full version.

External Photos page 1 Model No.:CardioMessengr Smart 3G FCC ID: QRICMSMART IC: 4708A-CMSMART Test Report No.: G0M-1309-3226-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany

Internal Photos page 1 Model No.:CardioMessengr Smart 3G FCC ID: QRICMSMART IC: 4708A-CMSMART Test Report No.: G0M-1309-3226-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany

Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany SAR TEST REPORT FCC 47 CFR Part 2.1093 Industry Canada RSS-102 RF-Exposure evaluation of portable equipment Report Reference No. .................... : G0M-1309-3226-TFC093S-V01 Testing Laboratory ........................ : Eurofins Product Service GmbH Address ............................................ : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation .................................... : A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Filed Test Laboratory, Reg.-No.: 96970 IC OATS Filing assigned code: 3470A Applicant’s name ........................... : Biotronik SE & Co. KG Address ............................................ : Woermannkehre 1 12359 Berlin GERMANY Test specification: Standard ........................................... : FCC 47 CFR Part 2 §2.1093 FCC OET Bulletin 65 Supplement C 01 -01 IEEE Std. 1528 - 2003 IC RSS-102 Issue 4 Safety Code 6 (2009) Non-standard test method..............: None Test scope.............. ....................... : complete Radio compliance test Equipment under test (EUT): Product description Telemonitoring System Model No. CardioMessenger Smart 3G Hardware version CardioMessenger Smart 3G mit LP, Best.LP1/TelexSmart3G, LP, Best.LP1/TelexSmart3G_JP Rev. Dx Firmware / Software version SMARTAPP 1.x FCC-ID: QRICMSMART IC: 4708A-CMSMART Test result Passed Page 1 of 122 Page 2 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Version History Version Issue Date Remarks Revised by 01 2013-12-17 Initial Release Page 3 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 6 1.1 Equipment photos 8 1.2 Equipment setup photos 11 1.3 Reference Documents 13 1.4 Supporting Equipment Used During Testing 14 1.5 Supported standalone operating modes 15 1.6 Conducted Power Values 16 1.1 Standalone Operational Mode Test Exclusion 18 1.2 Supported concurrent (multi-transmitter) operating modes 19 1.3 Supported use cases 20 1.4 Radio Test Modes 21 1.5 Test Positions 22 1.6 Test Equipment Used During Testing 23 2 RESULT SUMMARY 24 3 DEFINITIONS 25 3.1 Controlled Exposure 25 3.2 Uncontrolled Exposure 25 3.3 Localized SAR 25 4 LOCALIZED SAR MEASUREMENT EQUIPMENT 26 4.1 Complete SAR DASY5 Measurement System 26 4.2 Robot Arm 28 4.3 Data Acquisition Electronics 28 4.4 Isotropic E-Field Probe ≤ 3 GHz 29 4.5 Isotropic E-Field Probe ≤ 6 GHz 30 4.6 Test phantom and positioner 31 4.7 System Validation Dipoles 32 5 SINGLE-BAND SAR MEASUREMENT 33 5.1 General measurement description 33 5.2 SAR measurement description 33 5.3 Reference lines and points for Handsets 34 5.4 Test positions relative to the Head 35 5.5 Test positions relative to the human body 36 5.6 Measurement Uncertainty 37 Page 4 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 6 TEST CONDITIONS AND RESULTS 38 6.1 Test Conditions and Results – Tissue Validation 38 6.2 Test Conditions and Results – System Validation 40 6.3 Test Conditions and Results – Standalone SAR Measurement 42 6.4 Test Conditions and Results – Multi-band SAR Assessment 44 ANNEX A Calibration Documents 45 ANNEX B System Validation Reports 86 ANNEX C SAR Measurement Reports 92 Page 5 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1 Equipment (Test item) Description Description Telemonitoring System Model CardioMessenger Smart 3G Serial number None Hardware version CardioMessenger Smart 3G mit LP, Best.LP1/TelexSmart3G, LP, Best.LP1/TelexSmart3G_JP Rev. Dx Software / Firmware version SMARTAPP 1.x FCC-ID QRICMSMART IC 4708A-CMSMART Equipment type End product Prototype or production unit Identical Prototype Device category Handset Environment General public Radio technologies MedRadio GSM/GRPS850, Power Class 4, Multislot Class 8 EGPRS850, Power Class E2, Multislot Class 8 GSM/GRPS1900, Power Class 1, Multislot Class 8 EGPRS1900, Power Class E2, Multislot Class 8 WCDMA FDDII, Power Class 3 WCDMA FDDIV, Power Class 3 WCDMA FDDV, Power Class 3 HSDPA HSUPA Operating frequency ranges MedRadio : 402 MHz – 405 MHz GRPS / EGPRS 850 : 824 MHz - 849 MHz GRPS / EGPRS 1900 : 1850 MHz - 1910 MHz WCDMA FDDII : 1850 MHz - 1910 MHz WCDMA FDDIV : 1710 MHz - 1755 MHz WCDMA FDDV : 824 MHz - 849 MHz Antenna MedRadio Type integrated Model pcb antenna Manufacturer Biotronik SE & Co. KG Gain -5 dBi Antenna GPRS / EGPRS / WCDMA Type integrated Model pcb antenna Manufacturer Biotronik SE & Co. KG Gain GSM 850 = 1.6 dBi GPRS 1900 = 2.4 dBi FDDV = 1.6 dBi FDDII = 2.4 dBi FDDIV = 3.2 dBi Page 6 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Power supply V NOM 3.7 VDC (Lithium Battery) AC/DC-Adaptor Model N/A Vendor N/A Input N/A Output N/A Accessories None Manufacturer Biotronik SE & Co. KG Woermannkehre 1 12359 Berlin Germany Page 7 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.1 Equipment photos EUT TOP EUT BOTTOM Page 8 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany EUT SIDE VIEW EUT ID Page 9 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.2 Equipment setup photos EUT FLAT FRONT EUT FLAT FRONT Page 11 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany EUT FLAT BACK EUT FLAT BACK Page 12 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Produ…

Text truncated - open the document above for the full version.

Page 62 of 122 Page 63 of 122 Page 64 of 122 Page 65 of 122 Page 66 of 122 Page 67 of 122 Page 68 of 122 Page 69 of 122 Page 70 of 122 Page 71 of 122 Page 72 of 122 Page 73 of 122 Page 74 of 122 Page 75 of 122 Page 76 of 122 Page 77 of 122 Page 78 of 122 Page 79 of 122 Page 80 of 122 Page 81 of 122 Page 82 of 122 Page 83 of 122 Page 84 of 122 Page 85 of 122 Test Report No.: G0M-1309-3226-TFC093S-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany ANNEX B System Validation Reports Page 86 of 122 Date/Time: 27.11.2013 08:01:03 Test Laboratory: Eurofins Product Service GmbH Dipol Valid.900 (m)_250mW 27.11.2013 DUT: Dipole 900 MHz; Type: D900V2; Serial: 164 Communication System: UID 0 - n/a, CW; Frequency: 900 MHz;Duty Cycle: 1:1 Medium: Muscle 900 MHz Medium parameters used: f = 900 MHz; σ = 1.03 S/m; ε r = 54.419; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19-2007) DASY5.2 Configuration:
Probe: ET3DV6 - SN1711; ConvF(5.99, 5.99, 5.99); Calibrated: 18.09.2013;
Sensor-Surface: 4mm (Mechanical Surface Detection)
Electronics: DAE3 Sn522; Calibrated: 11.09.2013
Phantom: SAM with CRP; Type: SAM; Serial: TP-1217
Measurement SW: DASY52, Version 52.8 (6); SEMCAD X Version 14.6.9 (7117) System Performance Check at Frequencies below 1 GHz/d=15mm, Pin=250 mW, dist=4.0mm (ET-Probe)/Area Scan (7x11x1): Measurement grid: dx=15mm, dy=15mm Maximum value of SAR (measured) = 2.98 W/kg System Performance Check at Frequencies below 1 GHz/d=15mm, Pin=250 mW, dist=4.0mm (ET-Probe)/Zoom Scan (7x7x7) (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm, dz=5mm Reference Value = 56.199 V/m; Power Drift = -0.03 dB Peak SAR (extrapolated) = 4.00 W/kg SAR(1 g) = 2.8 W/kg; SAR(10 g) = 1.84 W/kg Maximum value of SAR (measured) = 3.04 W/kg Page 87 of 122 Date/Time: 05.12.2013 07:02:44 Test Laboratory: Eurofins Product Service GmbH Dipol Valid.900 (m)_250mW 05.12.2013 DUT: Dipole 900 MHz; Type: D900V2; Serial: 164 Communication System: UID 0 - n/a, CW; Frequency: 900 MHz;Duty Cycle: 1:1 Medium: Muscle 900 MHz Medium parameters used: f = 900 MHz; σ = 1.03 S/m; ε r = 54.419; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19-2007) DASY5.2 Configuration:
Probe: ET3DV6 - SN1711; ConvF(5.99, 5.99, 5.99); Calibrated: 18.09.2013;
Sensor-Surface: 4mm (Mechanical Surface Detection)
Electronics: DAE3 Sn522; Calibrated: 11.09.2013
Phantom: SAM with CRP; Type: SAM; Serial: TP-1217
Measurement SW: DASY52, Version 52.8 (6); SEMCAD X Version 14.6.9 (7117) System Performance Check at Frequencies below 1 GHz/d=15mm, Pin=250 mW, dist=4.0mm (ET-Probe)/Area Scan (7x11x1): Measurement grid: dx=15mm, dy=15mm Maximum value of SAR (measured) = 3.16 W/kg System Performance Check at Frequencies below 1 GHz/d=15mm, Pin=250 mW, dist=4.0mm (ET-Probe)/Zoom Scan (7x7x7) (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm, dz=5mm Reference Value = 57.708 V/m; Power Drift = -0.00 dB Peak SAR (extrapolated) = 4.27 W/kg SAR(1 g) = 2.98 W/kg; SAR(10 g) = 1.96 W/kg Maximum value of SAR (measured) = 3.25 W/kg Page 88 of 122 Date/Time: 03.12.2013 11:17:14 Test Laboratory: Eurofins Product Service GmbH Dipol Valid.1800 (m)_250mW 03.12.2013 DUT: Dipole 1800 MHz (D1800V2); Type: SA AAD 180 BA; Serial: 2d046 Communication System: UID 0 - n/a, CW; Frequency: 1800 MHz;Duty Cycle: 1:1 Medium: Muscle 1800 MHz Medium parameters used: f = 1800 MHz; σ = 1.584 S/m; ε r = 54.283; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19-2007) DASY5.2 Configuration:
Probe: ET3DV6 - SN1711; ConvF(4.69, 4.69, 4.69); Calibrated: 18.09.2013;
Sensor-Surface: 4mm (Mechanical Surface Detection)
Electronics: DAE3 Sn522; Calibrated: 11.09.2013
Phantom: SAM with CRP; Type: SAM; Serial: TP-1217
Measurement SW: DASY52, Version 52.8 (6); SEMCAD X Version 14.6.9 (7117) System Performance Check at Frequencies above 1 GHz/d=10mm, Pin=250 mW, dist=4.0mm (ET-Probe)/Area Scan (7x11x1): Measurement grid: dx=15mm, dy=15mm Maximum value of SAR (measured) = 11.2 W/kg System Performance Check at Frequencies above 1 GHz/d=10mm, Pin=250 mW, dist=4.0mm (ET-Probe)/Zoom Scan (7x7x7) (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm, dz=5mm Reference Value = 90.874 V/m; Power Drift = -0.07 dB Peak SAR (extrapolated) = 16.8 W/kg SAR(1 g) = 10.3 W/kg; SAR(10 g) = 5.58 W/kg Maximum value of SAR (measured) = 11.7 W/kg Page 89 of 122 Date/Time: 04.12.2013 07:17:31 Test Laboratory: Eurofins Product Service GmbH Dipol Valid.1900 (m)_250mW 04.12.2013 DUT: Dipole 1900 MHz; Type: D1900V2; Serial: 5d025 Communication System: UID 0 - n/a, CW; Frequency: 1900 MHz;Duty Cycle: 1:1 Medium: Muscle 1900 MHz Medium parameters used: f = 1900 MHz; σ = 1.464 S/m; ε r = 54.371; ρ = 1000 kg/m 3 Phantom section: Flat Section Measurement Standard: DASY5 (IEEE/IEC/ANSI C63.19-2007) DASY5.2 Configuration:
Probe: ET3DV6 - SN1711; ConvF(4.69, 4.69, 4.69); Calibrated: 18.09.2013;
Sensor-Surface: 4mm (Mechanical Surface Detection)
Electronics: DAE3 Sn522; Calibrated: 11.09.2013
Phantom: SAM with CRP; Type: SAM; Serial: TP-1217
Measurement SW: DASY52, Version 52.8 (6); SEMCAD X Version 14.6.9 (7117) System Performance Check at Frequencies above 1 GHz/d=10mm, Pin=250 mW, dist=4.0mm (ET-Probe)/Area Scan (7x11x1): Measurement grid: dx=15mm, dy=15mm Maximum value of SAR (measured) = 11.4 W/kg System Performance Check at Frequencies above 1 GHz/d=10mm, Pin=250 mW, dist=4.0mm (ET-Probe)/Zoom Scan (7x7x7) (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm, dz=5mm Reference Value = 95.319 V/m; Power Drift = -0.01 dB Peak SAR (extrapolated) = 16.4 W/kg SAR(1 g) = 10.5 W/kg; SAR(10 g) = 5.88 W/kg Maximum value of SAR (measured) = 11.7 W/kg Page 90 of 122 Date/Time: 04.12.2013 07:17:31 Test Laboratory: Eurofins Product Service GmbH Dipol Valid.1900 (m)_250mW 04.12.2013 DUT: Dipole 1900 MHz; Type: D1900V2; Serial: 5d025 Communication System: UID 0 - n/a, CW; Frequency: 1900 M…

Text truncated - open the document above for the full version.

Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 94 FCC TEST REPORT FCC 47 CFR Part 95I Medical Device Radiocommunication Service (MedRadio) Industry Canada RSS-243 Medical Devices Operating in the 401 – 406 MHz Frequency Band Report Reference No. .................... : G0M-1309-3225-TFC95IM-V01 Testing Laboratory ........................ : Eurofins Product Service GmbH Address ............................................ : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation .................................... : A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Filed Test Laboratory, Reg.-No.: 96970 IC OATS Filing assigned code: 3470A Applicant’s name ........................... : Biotronik SE & Co. KG Address ............................................ : Woermannkehre 1 12359 Berlin GERMANY Test specification: Standard ........................................... : 47 CFR Part 95E 47 CFR Part 95I 47 CFR Part 15C 47 CFR Part 2 RSS-243, Issue 3, 2010-02 RSS-Gen, Issue 3, 2010-12 ANSI C63.4:2009 EN 301 839-1 V1.3.1:2009-10 Equipment under test (EUT): Product description Telemonitoring System Model No. CardioMessenger Smart 2G/3G Hardware version CardioMessenger Smart 3G mit LP, Best.LP1/TelexSmart3G, Rev. Dx Firmware / Software version SMARTAPP 1.x FCC-ID: QRICMSMART IC: 4708A-CMSMART Test result Passed Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 94 Version History Version Issue Date Remarks Revised by 01 2013-12-17 Initial Release Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 94 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 5 1.1 Photos - Equipment external 7 1.2 Photos - Equipment internal 8 1.3 Photos – Test setup 9 1.4 Supporting Equipment Used During Testing 10 1.5 Test Modes 11 1.6 Test Equipment Used During Testing 12 1.7 Sample emission level calculation 14 2 RESULT SUMMARY 15 3 TEST CONDITIONS AND RESULTS 16 3.1 Test Conditions and Results – Occupied Bandwidth 16 3.2 Test Conditions and Results – Emission Bandwidth 20 3.3 Test Conditions and Results – Frequency stability 23 3.4 Test Conditions and Results – Transmitter output power 25 3.5 Test Conditions and Results – Band-edge compliance 27 3.6 Test Conditions and Results – Transmitter unwanted emissions 29 3.7 Test Conditions and Results – Receiver spurious emissions 31 3.8 Test Conditions and Results – AC power line conducted emissions 33 3.9 Test Conditions and Results – System threshold power levels 38 3.10 Test Conditions and Results – Monitoring system bandwidth 41 3.11 Test Conditions and Results – Scan cycle time 45 3.12 Test Conditions and Results – Minimum channel monitoring period 48 3.13 Test Conditions and Results – Channel access 51 3.14 Test Conditions and Results – Discontinuation of MICS or MEDS session 55 ANNEX A Transmitter output power 58 ANNEX B Transmitter radiated spurious emissions 65 ANNEX C Receiver radiated spurious emissions 89 Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 94 1 Equipment (Test item) Description Description Telemonitoring System Model CardioMessenger Smart 2G/3G Serial number None Hardware version CardioMessenger Smart 3G mit LP, Best.LP1/TelexSmart3G, Rev. Dx Software / Firmware version SMARTAPP 1.x FCC-ID QRICMSMART IC 4708A-CMSMART Equipment type End product Radio type Transceiver Number of Radios 1 Transceivers are built into the device Radio technology MedRadio (MICS) programmer / control tranmitter Operating frequency range 402.45 - 404.85 MHz Assigned frequency band 402 - 405 MHz Main test frequencies F LOW 402.45 MHz F MID 403.65 MHz F HIGH 404.85 MHz Modulations FSK Emission designator F1D Number of channels 9 Channel spacing 300 kHz Spectrum access Listen before transmit Number of antennas 1 Antenna 1 Type integrated Model loop antenna Manufacturer see Manufacturer Gain -5 dBi (Determined by measurements) Manufacturer Biotronik SE & Co. KG Woermannkehre 1 12359 Berlin GERMANY Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 94 Power supply V NOM 3.7 VDC V MIN 3.1 VDC V MAX 4.16 VDC Temperature T NOM 20°C T MIN -10 °C T MAX 40 °C AC/DC-Adaptor Model N/A Vendor N/A Input N/A Output N/A Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 94 1.1 Photos - Equipment external EUT TOP EUT BOTTOM EUT LEFT Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 94 1.3 Photos – Test setup Test setup – Radiated emissions Test setup – Conducted emissions Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 94 1.4 Supporting Equipment Used During Testing Product Type* Device Manufacturer Model No. Comments SIM Test board Implant Simulator Biotronik SE & Co. KG None Companion device for monitoring test *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M-1309-3225-TFC95IM-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 94 1.5 Test Modes Mode # Description Unmodulated General conditions: EUT powered by laboratory power supply. Radio conditions: Mode = standalone transmit Spreading = None Modulation = None Duty cycle = 100 % Power level = Maximum Modulated General conditions: EUT powered by laboratory power supply. Radio conditions: Mode = standalone transmit Modulation = FSK Duty cycle = 100 % Power level = Maximum Monitoring A General conditions: EUT …

Text truncated - open the document above for the full version.

Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 38 EMC TEST REPORT FCC 47 CFR Part 15B Industry Canada RSS-Gen Electromagnetic compatibility - Unintentional radiators Report Reference No. .................... : G0M-1309-3226-EF01-V03 Testing Laboratory ........................ : Eurofins Product Service GmbH Address ............................................ : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation .................................... : A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Filed Test Laboratory, Reg.-No.: 96970 IC OATS Filing assigned code: 3470A Applicant’s name ........................... : Biotronik SE & Co. KG Address ............................................ : Woermannkehre 1 12359 Berlin GERMANY Test specification: Standard ........................................... : 47 CFR Part 15 Subpart B RSS-Gen, Issue 3, 2010-12 ANSI C63.4:2009 Equipment under test (EUT): Product description Telemonitoring System Model No. CardioMessenger Smart 3G Additional Models None Hardware version CardioMessenger Smart 3G mit LP, Best.LP1/TelexSmart3G, LP, Best.LP1/TelexSmart3G_JP Rev. Dx Firmware / Software version SMARTAPP 1.x Contains FCC-ID: QRICMSMART IC: 4708A-CMSMART Test result Passed Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 38 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 4 1.1 Photos – Equipment external 5 1.2 Photos – Equipment internal 6 1.3 Photos – Test setup 8 1.4 Supporting Equipment Used During Testing 10 1.5 Operating Modes 11 1.6 Test Equipment Used During Testing 12 1.7 Sample emission level calculation 13 2 RESULT SUMMARY 14 3 TEST CONDITIONS AND RESULTS 15 3.1 Test Conditions and Results – Radiated emissions 15 3.2 Test Conditions and Results – AC power line conducted emissions 34 Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 38 1 Equipment (Test item) Description Description Telemonitoring System Model CardioMessenger Smart 3G Hardware version CardioMessenger Smart 3G mit LP, Best.LP1/TelexSmart3G, LP, Best.LP1/TelexSmart3G_JP Rev. Dx Software / Firmware version SMARTAPP 1.x Contains FCC-ID QRICMSMART Contains IC 4708A-CMSMART Power supply 120 VAC AC/DC-Adaptor Model : FW7520/05 Manufacturer : Friwo Input : 100 - 240 / 50-60Hz Output : 5VDC / 3.0A Radio module Type Module Model HE910-D Manufacturer Telit HW Version 0 SW Version 12.00.024 FCC-ID RI7HE910 IC 5131A-HE910 IMEI 356870050003520 Manufacturer Biotronik SE & Co. KG Woermannkehre 1 12359 Berlin GERMANY Highest emission frequency 168 MHz Device classification Class B Equipment type Tabletop Number of tested samples 1 Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 38 1.1 Photos – Equipment external Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 8 of 38 1.3 Photos – Test setup Test Setup : Radiated Emissions Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 38 Test Setup : Conducted Emissions Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 38 1.4 Supporting Equipment Used During Testing Product Type* Device Manufacturer Model No. Comments EUT Power Supply Friwo FW7520/05 - AE Radio Communication Tester R&S CMU200 - *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 38 1.5 Operating Modes Mode # Description 1 UMTS Band V link to Radio Communication Tester + MICS 2 UMTS Band V link to Radio Communication Tester + MICS + charging 3 GSM850 link to Radio Communication Tester + MICS + charging Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 12 of 38 1.6 Test Equipment Used During Testing Radiated emissions Description Manufacturer Model Identifier Cal. Date Cal. Due Biconical Antenna R&S HK 116 EF00012 2013-02 2016-02 LPD-Antenne R&S HL 223 EF00187 2011-02 2014-02 LPD-Antenna R&S HL 025 EF00327 2013-02 2016-02 EMI Test Receiver R&S ESU8 EF00379 2013-03 2014-03 EMI Test Receiver R&S ESCS30 EF00295 2013-10 2014-10 Conducted emissions Description Manufacturer Model Identifier Cal. Date Cal. Due AMN R&S ESH2-Z5 EF00182 2012-10 2014-10 AMN R&S ESH3-Z5 EF00036 2012-11 2014-11 EMI Test Receiver R&S ESCS 30 EF00295 2013-10 2014-10 Test Report No.: G0M-1309-3226-EF01-V03 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 13 of 38 1.7 Sample emission level calculation The following is a description of terms and a sample calculation, as appears in the radiated emissions data table. The numbers used in the calculation are for example only. There is no direct correlation to the specific data taken for the product described in this document: Reading: This is the reading obtained on the spectrum analyzer in dBμV. Any external preamplifiers used are taken into account through internal analyzer settings. A.F.: This is the antenna factor for the receiving antenna. It is a conver…

Text truncated - open the document above for the full version.