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  3. 2AAGY-BETAC1

2AAGY-BETAC1BETACONNECT is a re-usable electronic autoinjector that is intended to help the user by automating subcutaneous injection. The BETACONNECT will automatically performs a four phase injection.

Phillips-Medisize A/S
BETACONNECT is a re-usable electronic autoinjector that is intended to help the user by automating subcutaneous injection. The BETACONNECT will automatically performs a four phase injection. - FCC ID 2AAGY-BETAC1 - Phillips-Medisize A/S
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Nov 26, 2013
Application Purpose
Original Equipment
Date of Application
Nov 26, 2013
Equipment Note
BETACONNECT is a re-usable electronic autoinjector that is intended to help the user by automating subcutaneous injection. The BETACONNECT will automatically performs a four phase injection.
Frequency Range
2402.00000000 - 2480.00000000
Company
Phillips-Medisize A/S
Country
Denmark

Documents & Files

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Users Manual

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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Operational Description

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

1 BETACONNECT TM Instructions for use Language: English Version: 2013-10 2 Table of Contents Chapter 1: First Time Use........................................................................................... 4 1.1. First time use of BETACONNECT TM ............................................................. 4 1.2. Operator Profile and Applied parts ................................................................ 4 1.3. Intended Use ................................................................................................. 4 Chapter 2: Things you should know about the BETACONNECT TM ............................ 5 2.1. Overview ....................................................................................................... 5 2.2. Which syringe can be used with the BETACONNECT TM ? / Injection volumes 5 2.3. Charging the BETACONNECT TM .................................................................. 6 2.4. Care, storage and disposal ............................................................................ 6 2.5. Cleaning ........................................................................................................ 7 Chapter 3: Injection Process ....................................................................................... 8 3.1. Preparing BETACONNECT TM for injection .................................................... 8 3.2. Injection procedure ........................................................................................ 9 3.3. Removing the used syringe and needle ...................................................... 10 Chapter 4: Adjustments ............................................................................................ 12 4. .................................................................................................................... 12 4.1. Adjusting the injection depth ........................................................................ 12 4.2. Adjusting the injection speed ....................................................................... 12 4.3. Setting the reminder function ....................................................................... 13 Chapter 5: Trouble shooting ..................................................................................... 14 Chapter 6: Technical Specifications ......................................................................... 16 6.1. Labeling ....................................................................................................... 16 6.2. Technical Specification ................................................................................ 17 3 Important notes Warning! Whenever you see this symbol it means that safety instructions must be followed. Please read these instructions prior to using BETACONNECT TM for the first time. Please keep these instructions in a safe place.  Keep these Instructions for Use for future reference.  The BETACONNECT TM reminder function is only intended as a supplement to any memory system that you currently use to remind yourself to take your Betaseron ® . You will maintain full responsibility to administer your medication at the appropriate time and to follow the instructions from your Healthcare Professional.  Use only syringes provided with your Betaseron ® with the BETACONNECT TM .  Caution, the syringes are made of glass and can break if dropped or hit too hard.  The BETACONNECT TM must never be pointed at another person or yourself except in order to inject Betaseron ®  The BETACONNECT TM is not intended for use on more than one patient (danger of infection).  The BETACONNECT TM cannot be sterilized.  The BETACONNECT TM may not be opened or repaired as no modification of this equipment is allowed. The batteries are not replaceable.  This BETACONNECT TM contains re-chargeable batteries. Do not expose to extreme heat or fire. Avoid storage in direct sunlight.  The BETACONNECT TM is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it.  Keep the BETACONNECT TM and the accessories (e.g. cables) out of reach of children. The cables can lead to possible strangulation.  The BETACONNECT TM is an electronic device and must be handled with care.  Do not use the BETACONNECT TM if, during normal use or during recharging, it does not function in accordance with the instructions or if it seems to be damaged.  Do not use charger and cables other than those provided with the BETACONNECT TM as this may result in increased emission, decreased immunity and reduced electrical safety of the BETACONNECT TM .  For correct function of BETACONNECT TM you must keep the safety release at the front of the BETACONNECT TM clean using a dry/damp cloth or alcohol wipe.  Only inject into bare skin do not inject through clothes.  Do not use the BETACONNECT TM in oxygen rich environment.  Do not use the BETACONNECT TM if:  The prefilled syringe cannot be inserted or removed as described.  The syringe was not completely emptied during the last attempt to use the BETACONNECT TM . Note if the injection has been interrupted, the syringe will not be completely emptied.  If unexpected events occur or BETACONNECT TM does not operate as described in this instruction for use. 4 Chapter 1: First Time Use 1.1. First time use of BETACONNECT TM The folder box contains the following items:  BETACONNECT TM  Packaging to store your BETACONNECT TM  Charger to charge your BETACONNECT TM  USB cable  Quick guide  Instruction for use. Remove your BETACONNECT TM from its package. 1.2. Operator Profile and Applied parts BETACONNECT TM is designed to be used by MS patients (tested with MS patients from 18 years onwards), who have been found capable by MS nurses / health care professionals to operate and perform injections using BETACONNECT TM . These patients should be able to perform the reconstitution and preparation of the disposable (user filled) syringe to the proper dose …

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External Photos

External Photos page 1 Model No.:betaCONNECT FCC ID: 2AAGY-BETAC1 IC: 3775E-BEAC1 Test Report No.: G0M-1305-2859-TFC247W-V01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany External Photos page 2 Model No.:betaCONNECT FCC ID: 2AAGY-BETAC1 IC: 3775E-BEAC1 Test Report No.: G0M-1305-2859-TFC247W-V01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany

ID Label/Location Info

Tegningen tilhører Bang & Olufsen Medicom a/s, Struer, Danmark og må ikke afhændes, udlånes eller kopieres uden firmaets udtrykkelige skriftlige tilladelse. This drawing is the property of Bang & Olufsen Medicom a/s, Struer, Denmark and must not be transferred, lent or reproduced without an explicit written permission from the company. Bang & Olufsen Medicom CASE TOP, MOUNTING PLATE, INCL. PRINT, BBEPAGE 1 OF 1 SCALE 1:1 DESIGNER ASM/DRW: ASSEMBLY: 13130702_01 DRAWING: 13130702_01 INIT. DESIGNER: ASM DATE: DRAWING DATE: CREATION DATE: ASM REV: DRAWING REV: RELEASE LEVEL ASM/DRW: - NOT A WINDCHILL OBJECT - VOLUME: N.A. MUST BE IN ACCORDANCE WITH DIRECTIVE 2002/95/EC (RoHS) SIZE:A4 REF. NUMBERDRW. NUMBERREVISIONDESCRIPTION 113130702_00CASE TOP, MOUNTING PLATE, BBE REF. NUMBERDRW. NUMBERREVISIONDESCRIPTION 213130702_02PRINT FOR CASE TOP, MOUNTING PLATE, BBE 1 2 B A DRAFT/DRAFT 2013-10-31 SEE SEE/SEE 2013-10-31 A 2013-10-31 A Bang & Olufsen Medicom a/s Gimsinglundvej 20 DK - 7600 Struer 0543 0681 SN XXXXXXXXXXXXXX BETACONNECT TM IC: 3775E-BETAC1 FCC ID: 2AAGY-BETAC1 40°C 104°F 5°C 41°F 202-SMB067 D 13-0036 202 R T 12 10 8 YYYY-MM

ID Label/Location Info

Tegningen tilhører Bang & Olufsen Medicom a/s, Struer, Danmarkog må ikke afhændes, udlånes eller kopieresuden firmaets udtrykkelige skriftlige tilladelse. This drawing is the property of Bang & Olufsen Medicom a/s, Struer,Denmark and must not be transferred, lent or reproducedwithout an explicit written permission from the company. Bang & Olufsen Medicom 169.56 172.56 49.05 45.28 BUMBLEBEE, BBE PAGE 1 OF 2 SCALE 1:1 DESIGNER ASM/DRW: HHV/HHV ASSEMBLY: 19500300_00 DRAWING: 19500300_03 INIT. DESIGNER: HHV ASM DATE: 2013-06-11 DRAWING DATE: 2013-10-11 CREATION DATE: 2012-06-21 ASM REV: 6.1 DRAWING REV: 1.1 RELEASE LEVEL ASM/DRW: Draft/Design VOLUME: 125703.3 mm 3 MUST BE IN ACCORDANCE WITH DIRECTIVE 2002/95/EC (RoHS) SIZE:A3 VIEW 1 VIEW 2 VIEW 3 SCALE 1:2 SCALE 1:2 Tegningen tilhører Bang & Olufsen Medicom a/s, Struer, Danmarkog må ikke afhændes, udlånes eller kopieresuden firmaets udtrykkelige skriftlige tilladelse. This drawing is the property of Bang & Olufsen Medicom a/s, Struer,Denmark and must not be transferred, lent or reproducedwithout an explicit written permission from the company. Bang & Olufsen Medicom 16.84 27.94 7.9 3.7 SCALE 1:2 SCALE 1:2 98.56 BUMBLEBEE, BBE PAGE 2 OF 2 SCALE 1:1 DESIGNER ASM/DRW: HHV/HHV ASSEMBLY: 19500300_00 DRAWING: 19500300_03 INIT. DESIGNER: HHV ASM DATE: 2013-06-11 DRAWING DATE: 2013-10-11 CREATION DATE: 2012-06-21 ASM REV: 6.1 DRAWING REV: 1.1 RELEASE LEVEL ASM/DRW: Draft/Design VOLUME: 125703.3 mm 3 MUST BE IN ACCORDANCE WITH DIRECTIVE 2002/95/EC (RoHS) SIZE:A3 VIEW 1 VIEW 2 VIEW 3

Internal Photos

Internal Photos page 1 Model No.:betaCONNECT FCC ID: 2AAGY-BETAC1 IC: 3775E-BEAC1 Test Report No.: G0M-1305-2859-TFC247W-V01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany Internal Photos page 2 Model No.:betaCONNECT FCC ID: 2AAGY-BETAC1 IC: 3775E-BEAC1 Test Report No.: G0M-1305-2859-TFC247W-V01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany

RF Exposure Info

Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 12 RF-EXPOSURE ASSESSMENT REPORT FCC 47 CFR Part 2.1093 Industry Canada RSS-102 RF-Exposure evaluation of portable equipment Report Reference No. .................... : G0M-1305-2859-TFC093P-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 ........................... : Bang & Olufsen Medicom A/S Address ............................................ : Gimsinglundvej 20 7600 Struer DENMARK Test specification: Standard ........................................... : 47 CFR 1.1310 / 47 CFR 2.1091 / 47 CFR 2.1093 OET Bulletin 65:1997 KDB 447498 D01 v05r01:2013-05-28 RSS-102, Issue 4:2010 Safety Code 6:2009 Equipment under test (EUT): Product description Electronic Auto-injector Model No. betaCONNECT Hardware version B11 Firmware / Software version None FCC-ID: 2AAGY-BETAC1 IC: 3775E-BETAC1 Test result Passed Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 12 Version History Version Issue Date Remarks Revised by 01 2013-09-20 Initial Release Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 12 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 5 1.1 Reference Documents 6 1.2 Radiation Sources 7 2 RESULT SUMMARY 8 3 RF-EXPOSURE CLASSIFICATIONS 9 4 ASSESSMENT 10 4.1 SAR Exemption Assessment –FCC KDB447498 / RSS-102 10 Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 12 1 Equipment (Test item) Description Description Electronic Auto-injector Model betaCONNECT Serial number None Hardware version B11 Software / Firmware version None FCC-ID 2AAGY-BETAC1 IC 3775E-BETAC1 Equipment type End product Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 12 1.1 Reference Documents Document type Document No. Issued by Date FCC 15.247 Bluetooth Radio Report G0M-1305-2859-TFC247W-V01 Eurofins Product Service GmbH 2013-08-30 Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 12 1.2 Radiation Sources Mode # Description Bluetooth LE Frequency range [MHz] 2402 – 2480 Channels 40 Modulations GFSK Maximum peak power [dBm] 0.21 Maximum transmission duty cycle [%] 100 Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 8 of 12 2 Result Summary FCC 47 CFR Part 2.1093, KDB447498, IC RSS-102 Product Specific Standard Section Requirement Result Remarks 47 CFR 2.1093 KDB447498 SAR evaluation exemption : Bluetooth LE PASS RSS-102 2.5.1 SAR evaluation exemption : Bluetooth LE PASS Remarks: Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 12 3 RF-Exposure Classifications Device Types Fixed A fixed device is defined as a device physically secured at one fixed location and cannot be easily re-located. Mobile A mobile device is defined as a transmitting device designed to be used in other than fixed locations and to generally be used in such a way that a separation distance of at least 20 centimeters is normally maintained between the transmitter's radiating structure(s) and the body of the user or nearby persons. (47 CFR 2.1091) Portable A portable device is defined as a transmitting device designed to be used so that the radiating structure(s) of the device is/are within 20 centimeters of the body of the user. (47 CFR 2.1093) Exposure Categories Occupational / Controlled Limits apply in situations in which persons are exposed as a consequence of their employment provided those persons are fully aware of the potential for exposure and can exercise control over their exposure. Limits for occupational/controlled exposure also apply in situations when an individual is transient through a location where occupational/controlled limits apply provided he or she is made aware of the potential for exposure. General population / uncontrolled Exposures apply in situations in which the general public may be exposed, or in which persons that are exposed as a consequence of their employment may not be fully aware of the potential for exposure or cannot exercise control over their exposure. Test Report No.: G0M-1305-2859-TFC093P-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 12 4 Assessment 4.1 SAR Exemption Assessment –FCC KDB447498 / RSS-102 Low Power Exclusion acc. to FCC KDB447498 / IC RSS-102 Verdict: PASS Assessment according to reference Reference Method KDB447498 & 2.1093 / RSS-102 & Safety Code 6 Device type portable Exposure category General population FCC/IC SAR Limits Region Occupational SAR values [W/kg] General public SAR values [W/kg] Whole-body SAR averaging mass = entire body 0.4 0.08 Partial-body SAR averaging mass = 1g 8.0 1.6 Hands, Wrists, Feet and Ankles SAR averaging mass = 10g 20 4 FCC SAR test exclusion Excerpt from KDB 447498: Unless specifically required by the published RF exposure KDB procedures, standalone 1-g head or body and 10-g extremity SAR evaluation for general population exposure conditions, by measurement or numerical simulation, is not required when the corresponding SAR Exclusion Threshold condition, listed below, is satisfied. These test exclusion conditions are based on source-based time-averaged maximum conducted output power o…

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Test Report

Test Report No.: G0M-1305-2859-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 21 EMC TEST REPORT FCC 47 CFR Part 15B Industry Canada RSS-Gen Electromagnetic compatibility - Unintentional radiators Report Reference No. .................... : G0M-1305-2859-EF01-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 ........................... : Bang & Olufsen Medicom A/S Address ............................................ : Gimsinglundvej 20 7600 Struer DENMARK 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 Electronic Auto-injector Model No. betaCONNECT Additional Models None Hardware version B11 Firmware / Software version None FCC-ID: 2AAGY-BETAC1 IC: 3775E-BETAC1 Test result Passed Test Report No.: G0M-1305-2859-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 21 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 4 1.1 Photos – Equipment external 5 1.1 Photos – Equipment internal 6 1.2 Photos – Test setup 8 1.3 Supporting Equipment Used During Testing 9 1.4 Operating Modes 10 1.5 Test Equipment Used During Testing 11 1.6 Sample emission level calculation 12 2 RESULT SUMMARY 13 3 TEST CONDITIONS AND RESULTS 14 3.1 Test Conditions and Results – Radiated emissions 14 3.2 Test Conditions and Results – AC power line conducted emissions 19 Test Report No.: G0M-1305-2859-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 21 1 Equipment (Test item) Description Description Electronic Auto-injector Model betaCONNECT Additional Models None Serial number None Hardware version B11 Software / Firmware version None FCC-ID 2AAGY-BETAC1 IC 3775E-BETAC1 Power supply 120V AC/DC Adapter AC/DC-Adaptor Model ASUC30e-050100 Vendor Aquilstar Precision Industrial Input 100-240VAC, 50-60Hz Output 5.0V Manufacturer Bang & Olufsen Medicom A/S Gimsinglundvej 20 7600 Struer DENMARK Highest emission frequency 0.4 MHz Device classification Class B Equipment type Tabletop Number of tested samples 1 Test Report No.: G0M-1305-2859-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 21 1.3 Supporting Equipment Used During Testing Product Type* Device Manufacturer Model No. Comments None *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M-1305-2859-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 21 1.4 Operating Modes Mode # Description 1 active; motor with load; charging, Bluetooth link Test Report No.: G0M-1305-2859-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 21 1.5 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 ESCS 30 EF00297 2012-09 2013-09 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 EF00297 2012-09 2013-09 Test Report No.: G0M-1305-2859-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 12 of 21 1.6 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 conversion factor, which converts electric fields strengths to voltages, which can be measured directly on the spectrum analyzer. It is treated as a loss in dB. Cable losses have been included with the A.F. to simplify the calculations. The antenna factor is used in calculations as follows: Reading on Analyzer (dBμV) + A.F. (dB) = Net field strength (dBμV/m) Net: This is the net field strength measurement (as shown above). Limit: This is the FCC Class B radiated emission limit (in units of dBμV/m). The FCC limits are given in units of μV/m. The following formula is used to convert the units of μV/m to dBμV/m: Limit (dBμV/m) = 20*log (μV/m) Margin: This is the margin of compliance below the FCC limit. The units are given in dB. A negative margin indicates the emission was below the limit. A positive margin indicates that the emission exceeds the limit. Example only: Reading + AF = Net Reading : Net reading - FCC limit = Margin 21.5 dBμV + 26 dB = 47.5 dBμV/m : 47.5 dBμV/m - 57.0 dBμV/m = -9.5 dB Test Report No.: G0M-1305-2859-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 13 of 21 2 Result Summary FCC 47 CFR Part 15B, Industry Canada RSS-Gen Product Specific Standard Requirement – Test Reference Method Result Remarks 47 CFR 15.109 RSS-Gen 4.9 & 4.10 Radiated emissions ANSI C 63.4 PASS 47 CFR 15.107 RSS-Gen 7.2.4 AC power line conducted emissions ANSI C63.4 PASS Remarks: Test Report No.: G0M-1305-285…

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Test Report

Test Report No.: G0M-1305-2859-TFC247W-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 82 FCC TEST REPORT FCC 47 CFR Part 15C Industry Canada RSS-210 Digital transmission systems operating within the 2400 – 2483.5 MHz band Report Reference No. .................... : G0M-1305-2859-TFC247W-V02 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 ........................... : Bang & Olufsen Medicom A/S Address ............................................ : Gimsinglundvej 20 7600 Struer DENMARK Test specification: Standard ........................................... : 47 CFR Part 15C KDB Publication No. 558074 RSS-210, Issue 8, 2010-12 RSS-Gen, Issue 3, 2010-12 ANSI C63.4:2009 Equipment under test (EUT): Product description Electronic Auto-injector Model No. betaCONNECT Hardware version B11 Firmware / Software version None FCC-ID: 2AAGY-BETAC1 IC: 3775E-BETAC1 Test result Passed Test Report No.: G0M-1305-2859-TFC247W-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 82 Version History Version Issue Date Remarks Revised by 01 2013-08-30 Initial Release 02 2013-11-13 Calibration dates corrected C. Weber Test Report No.: G0M-1305-2859-TFC247W-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 82 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 5 1.1 Photos – Equipment External 6 1.2 Photos – Equipment internal 7 1.3 Photos – Test setup 8 1.4 Supporting Equipment Used During Testing 9 1.5 Test Modes 10 1.6 Test Equipment Used During Testing 11 1.7 Sample emission level calculation 12 2 RESULT SUMMARY 13 3 TEST CONDITIONS AND RESULTS 14 3.1 Test Conditions and Results – Occupied Bandwidth 14 3.2 Test Conditions and Results – 6 dB Bandwidth 18 3.3 Test Conditions and Results – Maximum peak conducted power 22 3.4 Test Conditions and Results – Power spectral density 24 3.5 Test Conditions and Results – AC power line conducted emissions 25 3.6 Test Conditions and Results – Band edge compliance 28 3.7 Test Conditions and Results – Conducted spurious emissions 31 3.8 Test Conditions and Results – Transmitter radiated emissions 35 3.9 Test Conditions and Results – Receiver radiated emissions 37 ANNEX A Transmitter radiated spurious emissions 39 ANNEX B Receiver radiated spurious emissions 75 Test Report No.: G0M-1305-2859-TFC247W-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 82 1 Equipment (Test item) Description Description Electronic Auto-injector Model betaCONNECT Serial number None Hardware version B11 Software / Firmware version None FCC-ID 2AAGY-BETAC1 IC 3775E-BETAC1 Equipment type Radio module Radio type Transceiver Radio technology Bluetooth 4.0 Low Energy Operating frequency range 2402 - 2480 MHz Assigned frequency band 2400 - 2483.5 MHz Main test frequencies F LOW 2402 MHz F MID 2440 MHz F HIGH 2480 MHz Spreading None Modulations GFSK Number of channels 40 Channel spacing 2MHz Number of antennas 1 Antenna Type integrated Model 2450AT18B100 Manufacturer Johanson Technology Gain -0.5 dBi (manufacturer declaration) Manufacturer Bang & Olufsen Medicom A/S Gimsinglundvej 20 7600 Struer DENMARK Power supply V NOM 3.7 VDC V MIN 3.3 VDC V MAX 4.2 VDC AC/DC-Adaptor Model ASUC30e-050100 Vendor Aquilstar Precision Industrial Input 100-240VAC, 50-60Hz Output 5.0V Test Report No.: G0M-1305-2859-TFC247W-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 82 1.4 Supporting Equipment Used During Testing Product Type* Device Manufacturer Model No. Comments None *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M-1305-2859-TFC247W-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 82 1.5 Test Modes Mode # Description Transmit General conditions: EUT powered by laboratory power supply. Radio conditions: Mode = standalone transmit Spreading = None Modulation = GFSK Data rate = 1 Mbps Bandwidth = 2 MHz Duty cycle = 100 % Power level = Maximum Receive General conditions: EUT powered by laboratory power supply. Radio conditions: Mode = standalone receive (scan mode) Spreading = None Modulation = GFSK AC-Powerline General conditions: EUT powered by commercial Laptop Radio conditions: Mode = Transmit Spreading = None Test Report No.: G0M-1305-2859-TFC247W-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 82 1.6 Test Equipment Used During Testing Occupied Bandwidth Description Manufacturer Model Identifier Cal. Date Cal. Due Spectrum Analyzer R&S FSP 30 EF00312 2013-01 2014-01 6dB Bandwidth Description Manufacturer Model Identifier Cal. Date Cal. Due Spectrum Analyzer R&S FSP 30 EF00312 2013-01 2014-01 Maximum peak conducted power Description Manufacturer Model Identifier Cal. Date Cal. Due Spectrum Analyzer R&S FSP 30 EF00312 2013-01 2014-01 Power spectral density Description Manufacturer Model Identifier Cal. Date Cal. Due Spectrum Analyzer R&S FSP 30 EF00312 2013-01 2014-01 Band edge compliance Description Manufacturer Model Identifier Cal. Date Cal. Due Spectrum Analyzer R&S FSP 30 EF00312 2013-01 2014-01 Conducted spurious emissions Description Manufacturer Model Identifier Cal. Date Cal. Due Spectrum Analyzer R&S FSP 30 EF00312 2013-01 2014-01 Radiated spurious emissions Description Manufacturer Model Identifier Cal. Date Cal. Due Semi-anechoic chamber Frankonia AC 5 EF00395 - - Spectrum Analyzer R&S FSIQ26 EF00242 2013-06 2014-06 Biconical Antenna R&S HK 116 EF00012…

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Test Setup Photos

Test Set-Up Photos page 1 Model No.:betaCONNECT FCC ID: 2AAGY-BETAC1 IC: 3775E-BEAC1 Test Report No.: G0M-1305-2859-TFC247W-V01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany

Contact Information

Applicant

Carsten Pedersen(Program Manager)
[email protected]00457030Fax: 004570301700

Test Firm

Eurofins Product Service GmbHRobert Kschiwan-Kaspar
[email protected]49-33631-888-000Fax: 49-33631-888-660

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz1.00 mW
Confidentiality
Long Term
Grant Notes
Output power listed is conducted. The antenna(s) used for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

Other Applications from Phillips-Medisize A/S

The Auto-Injector is a re-usable, electronic  auto-injector intended for the delivery of a  full, single dose. The Auto-Injector has a  BLE connectivity feature - FCC ID 2AAGY-SKYT2 - Phillips-Medisize A/S
2AAGY-SKYT2

The Auto-Injector is a re-usable, electronic auto-injector intended for the delivery of a full, single dose. The Auto-Injector has a BLE connectivity feature

Sep 12, 2024

Equipment Class

DTS - Digital Transmission System