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  3. 2AAGY-SKYT2

2AAGY-SKYT2The 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

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
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Sep 12, 2024
Application Purpose
Original Equipment
Date of Application
Sep 12, 2024
Equipment Note
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
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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Attestation Statements

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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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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

Ascendis Pharma Customer Support 1-844-44ASCENDIS (1-844-442-7236) Device expiration Keep Track of Your Injections This is your Instructions for Use • For quick overview of steps, read your Quick Reference Guide • For training video, go to www.skytrofa.com 02 2024-08-27 8020100530_04 Distributed by: Ascendis Pharma Endocrinology Inc. Princeton, NJ 08540 USA Phillips-Medisize A/S Gimsinglundvej 20 DK-7600 Struer Denmark Instructions for Use Instructions for Use Quick Reference Guide Training Video Single-patient use This Instructions for Use has been approved by [Placeholder] Approved: Month, Year 8020100530_02(2089879865) Page 1 of 2 Needle To be screwed onto SKYTROFA Cartridge before inserting the cartridge in green top SKYTROFA Cartridge Contains medicine and water for injection. If refrigerated, leave it at room temperature for 15 minutes before use Battery Icon 85 Parts Overview Getting Started How to Use Troubleshooting and Care Product Information 14710 25811 369 12 Green Top Starts injection when pressed against skin Inspection Window Allows for inspection of mixed medicine Progress Bar (with six light elements) Shows progress of mixing and injection b Read more on pages 30-35 and 42-43 (and pages 52-53 for troubleshooting) Status Icons Green Button To turn on the SKYTROFA Auto-Injector or to reject mixed medicine Green Check Mark Injection successfully completed Constant Green a Battery is fully charged a The auto-injector is ready to use Green Eye Mixed medicine is ready for inspection in window Flashing Green a At least 1 injection remaining, but charging recommended after use Green Mixing Medicine mixing is in progress Flashing Orange a Battery needs charging Status Icons b Read more about status icons on pages 26-45 (and pages 52-63 for troubleshooting) b Read more about battery status icons on page 25 8020100530_02(2089879865) Page 1 of 2

Users Manual

8020100530_02(2089879865)Page 1 of 84 • Important Information • Before You Begin • Setting Up • Pairing with Mobile App • Step-by-Step Guide • Troubleshooting • Cleaning and Maintenance • Charging and Charging Cable • Storing • Product Safety • Expiration • EMC Compliance Levels • Technical Specification • Symbols • Warranty and Disclaimer • Parts Overview 1 2 8020100530_02(2089879865) Page 2 of 84 Introduction Intended Purpose and Device Description: The SKYTROFA Auto-Injector is intended to automate the reconstitution (mixing) and subcutaneous (under the skin) injection of lonapegsomatropin in patients prescribed once weekly growth hormone therapy. Injections are given subcutaneously once weekly in the abdomen, thighs, or buttocks. The intended users are patients prescribed with SKYTROFA, caregivers, and healthcare providers. Always use SKYTROFA exactly as your healthcare provider has told you. If you are unsure about your medicine, contact your healthcare provider. Consult your healthcare provider to be advised to perform self-administration or administration by your caregiver. The auto-injector is an electromechanical, reusable, single-patient use, and single- dose delivery device designed for personal home use. This means that a patient or 8020100530_02(2089879865) Page 3 of 84 3 caregiver can give injections at home without a healthcare provider present. A healthcare provider can use the auto-injector in a non-emergency clinical setting to inject a patient or demonstrate device use. Contraindications and Side Effects There are no contraindications related to the use of the auto-injector when it is used as intended. There are no side effects related to the use of the auto-injector when it is used as intended. For more information on SKYTROFA contraindications, side effects, disease, self-care, summary of safety, and clinical performance, please refer to the information enclosed with your medicine or contact your healthcare provider. If you get any side effects, contact your healthcare provider. Clinical Benefit of the SKYTROFA Auto-Injector SKYTROFA Auto-Injector does not convey any direct clinical benefits to the 4 8020100530_02(2089879865) Page 4 of 84 patient. Clinical benefits to patients are indirect, through enabling the treatment (lonapegsomatropin) to be administered. In combination with lonapegsomatropin drug product, the device enables the efficient delivery of growth hormone therapy using once weekly injections, which may reduce treatment burden. Step-by-step Instructions for the SKYTROFA Auto-Injector Read and follow these Instructions for Use that comes with your auto-injector before you start using it. This information does not replace talking to your healthcare provider about your medical condition or your treatment. The back cover of this Instructions for Use folds out for reference while you read the rest of the instructions. If you have any questions about the auto-injector, the medicine, or these instructions, please contact your healthcare provider or Ascendis Pharma Customer Support. For contact information b back cover. Getting Started 8020100530_02(2089879865) Page 5 of 84 5 Getting Started Page Important Information ................... 6 Before You Begin ........................... 9 Setting Up ..................................... 12 Pairing with Mobile App ............. 16 6 8020100530_02(2089879865) Page 6 of 84 Important Information Important information about your SKYTROFA Auto-Injector: Do not use the SKYTROFA Auto-Injector for the first time until you receive training from a healthcare provider. Follow these Instructions for Use for the auto-injector to avoid getting an injury, infection, or incorrect dose. The auto-injector can only be used with SKYTROFA Cartridges and needles that are prescribed by your healthcare provider. Cartridges and needles come together in the same packaging. Follow the instructions that come with SKYTROFA Cartridges. If refrigerated, take the cartridge out of the refrigerator and leave at room temperature for 15 minutes before use. Do not use your auto-injector with other medicines or needles than provided in the SKYTROFA Cartridge pack. Your weekly dose may require that you use 2 cartridges. Getting Started 7 8020100530_02(2089879865) Page 7 of 84 When this warning symbol is seen, safety instructions must be followed. Otherwise, serious safety hazardous situations and injuries may occur. Do not share your auto-injector with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. Keep out of the reach of children. This product contains small parts that may present a choking hazard to small children. The cable can present a strangulation hazard. Do not use or place the auto-injector closer than 12 inches (30 cm) to microwave ovens or electronic equipment with antennas such as WiFi transceivers. The auto-injector might not work the right way. 8 8020100530_02(2089879865) Page 8 of 84 When this precaution symbol is seen, safety instructions must be followed. Otherwise, minor to moderate safety hazardous situations and injuries and potential damage to the auto-injector or other property may occur. Do not reuse needles. Do not use a cartridge if it has been dropped or you think it may be damaged. Do not point the auto-injector at yourself or other people, except when you are ready to inject, to avoid needle stick injury. If your auto-injector turns off automatically, press and release the green button to turn it on again and read page 60 to proceed. If the auto-injector packaging has been damaged or unintentionally opened before first using it, please call Ascendis Pharma Customer Support. For contact information b back cover. Getting Started 9 8020100530_02(2089879865) Page 9 of 84 Before You Begin The SKYTROFA Auto-Injector Your healthcare provider will inform you that the SKYTROFA Auto-Injector, which comes in a separate package, is required for injec…

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Cover Letter(s)

Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 8/28/2024 U.S. Agent Designation Phillips-Medisize A/S acknowledges their consent for the following contact located in the United States to act as their agent for service of process for the equipment for which authorization is sought (FCC ID: 2AAGY-SKYT2): Name and company of U.S. agent: Julie Weghorn, Phillips-Medisize Physical U.S. address of agent: 2202 Carmichael Rd, Hudson, WI 54016, USA FRN of U.S. agent: NA. US Agent has no other business with FCC. Email address of U.S. agent: [email protected] Phillips-Medisize acknowledges their obligation to accept service of process on behalf of Phillips Medisize A/S. Phillips-Medisize A/S with the FRN 0022763536 accepts its obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission- related administrative or judicial proceeding involving the equipment, whichever is later. By signing this form, we confirm the above and that we are aware of the application requirements listed under § 2.911(d)(7). The information provided in this letter is based on the referenced rule parts of Title 47 of the CFR as well as KDB 986446 D01. An expiration date for this letter does not exist. In case the U.S. agent changes, the grantee is obligated to notify the FCC within 30 days via the granting TCB. Sincerely, Signature Jess Pihl Director Regulatory and Quality Phillips-Medisize A/S Signature Julie Weghorn Director, Global Quality & Regulatory Phillips-Medisize 48_Skytrofa US _Agent_2.911(d)(7) - U, V05 Docusign Envelope ID: 0CEC5ADE-58D8-4731-80F5-48D1D1C613A2

External Photos

MPS DIVISION SKYTROFA Revision: N/A External Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 1 of 5 SKYTROFA External Photos Revision: N/A Document ID: N/A MPS DIVISION SKYTROFA Revision: N/A External Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 2 of 5 1. External Photos The external photos of the SKYTROFA Auto-Injector are as follows: Figure 1: Side of the auto-injector with the brand name. Figure 2: Side of the auto-injector. MPS DIVISION SKYTROFA Revision: N/A External Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 3 of 5 Figure 3: Front side of the auto-injector. Figure 4: Back side of the auto-injector. MPS DIVISION SKYTROFA Revision: N/A External Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 4 of 5 Figure 5: Top side of the auto-injector. MPS DIVISION SKYTROFA Revision: N/A External Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 5 of 5 Figure 6: Bottom side of the auto-injector.

ID Label/Location Info

FCC ID: 2AAGY-SKYT2 G0M-2304-2021 Label Sample: FCC ID: 2AAGY-SKYT2 G0M-2304-2021 Label Posi�oning:

ID Label/Location Info

Tegningen tilhører Phillips Medisize,og må ikke afhændes, udlånes eller kopieresuden firmaets udtrykkelige skriftlige tilladelse. This drawing is the property of Phillips Medisize,and must not be transferred, lent or reproducedwithout an explicit written permission from the company. [4] 20.49 0.5 2 M [1] 8.02 0.5 [5]10 0.5 ( ) [2] 90.76 ( ) [3] 17.47 ( ) [16] 120.76 () [17]1.49 REF. NUMBERDRW. NUMBERDESCRIPTION 19020100048MONTER CONNECT, MTR ID View Type Class Proff ID Number of Characteristic View or Detail (Parent View) Safety, Function or Process (S, F or P) Capability (A, B, C or empty) Verification (V, K, Q or empty) IDViewTypeClassProof 11P 1P 31P 42P 52P 162P 172P Last ID used: 19 MODIFICATIONDRW REV 9120100049_Print01 updated. Version in BOM removedF 9120100049_print02 updated with FCC number. G RELEASE LEVEL PRT/DRW:Production Change/ Production Change SIZE:A3 DWG. NO.:9120100049PART:9120100049 DWG. REV:G PART REV:E.2 TYPE:ASSEMBLYVOLUME: 49082.9 mm 3 CREATED BY:APPROVED BY:DATE OF ISSUE:2024-07-16 TITLE:MONTER CONNECT, US, MTRPAGE 1 OF 2 SCALE 1:1 Note 2 View 2 Note 1 Parting line. Text to be placed according to dim 5 Note 2 Dotted line for illustration only. Text to be centred around line View 1 Note 1 1 Tegningen tilhører Phillips Medisize,og må ikke afhændes, udlånes eller kopieresuden firmaets udtrykkelige skriftlige tilladelse. This drawing is the property of Phillips Medisize,and must not be transferred, lent or reproducedwithout an explicit written permission from the company. () [7]83.97 ( ) [12] 1.26 () [8]1.47 ( ) [11] 4.3 () [9]4.13 (min. o) [13]8 ( ) [15] 1.7 ( ) [10]26 () [6]57.23 () [14]1.5 ( ) [18]12 ( ) [19] 3 ID View Type Class Proff ID Number of Characteristic View or Detail (Parent View) Safety, Function or Process (S, F or P) Capability (A, B, C or empty) Verification (V, K, Q or empty) IDViewTypeClassProof 61P 72P 82P 92P 102P 112P 122P 132P 142P 152P 182P 192P Last ID used: 19 RELEASE LEVEL PRT/DRW:Production Change/ Production Change SIZE:A3 DWG. NO.:9120100049PART:9120100049 DWG. REV:G PART REV:E.2 TYPE:ASSEMBLYVOLUME: 49082.9 mm 3 CREATED BY:APPROVED BY:DATE OF ISSUE:2024-07-16 TITLE:MONTER CONNECT, US, MTRPAGE 2 OF 2 SCALE 2:1 Note 2 Note 1 View 1 Note 2: Graphic according to 9120100049_print02.ai, outline according to 9120100049_print02.dxf Note 1: Graphic according to 9120100049_print01.ai, outline according to 9120100049_print01.dxf Text Zone A Text Zone B Text Zone C Text Zone A: The AI = (01) The Device Identifier (14 digits) Upper edge flush to datamatrix top. Text Zone B: The AI = (17) The Expiry date = YYMMDD Centered with datamatrix. Text Zone C: The AI = (21) The Serial Number (14 digits) Bottom edge flush to datamatrix bottom. Barcode Zone: GS1 DataMatrix Minimum size: 8 mm Symbol Grade: minimum 1.5 Quiet zone: minimum 1 mm Barcode Zone Note 4: Text Zone font is to be solid. Font Verdana, Regular, size 1.7 mm Note 3: All graphics to be Laser Engraved according to outline file View 2 Passkey Zone Passkey Zone: 6-digit numeric = XXXXXX Text centered in Zone Solid font, size 3 mm Font Verdana, Regular

Internal Photos

MPS DIVISION SKYTROFA Revision: N/A Internal Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 1 of 5 SKYTROFA Internal Photos Revision: N/A Document ID: N/A MPS DIVISION SKYTROFA Revision: N/A Internal Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 2 of 5 1. Internal Photos The internal photos of the SKYTROFA Auto-Injector are as follows: Figure 1: Top of the PCBs, indicating the PCB antenna. MPS DIVISION SKYTROFA Revision: N/A Internal Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 3 of 5 Figure 2: Back side of the PCBs, indicating the back of the PCB antenna. MPS DIVISION SKYTROFA Revision: N/A Internal Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 4 of 5 Figure 3: PCBA mounted on the side of the chassis, indicating the PCB Antenna. Figure 4: PCBA mounted on the front of the chassis. MPS DIVISION SKYTROFA Revision: N/A Internal Photos Document ID: N/A The information contained in this document is Confidential and Proprietary Business Information. TP4.2004, Revision 01 Page 5 of 5 Figure 5: PCBA mounted on the back of the chassis. Figure 6: Battery of the device mounted on the side of the chassis (the PCB antenna is placed on the opposite side of the battery).

RF Exposure Info

Test Report No.: G0M-2311-2313-TFC093PE-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 17 RF-EXPOSURE REPORT FCC 47 CFR Part 2.1093 RF-Exposure evaluation of portable equipment Report Reference No G0M-2311-2313-TFC093PE-V02 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Accreditation A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Test Firm Designation Number: DE0008 Applicant Phillips-Medisize A/S Address Gimsinglundvej 20 7600 Struer DENMARK Test Specification According to FCC rules Standard FCC 47 CFR 2.1093 Non-Standard Test Method None Equipment under Test (EUT): Product Description IDA0097 Auto-lnjector Model(s) IDA0097 Auto-lnjector, Model 02 Additional Model(s) None Brand Name(s) None Hardware Version(s) 2089879486 Software Version(s) 11.04.00 FCC ID 2AAGY-SKYT2 Test Result PASSED Test Report No.: G0M-2311-2313-TFC093PE-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 2 of 17 Possible test case verdicts: required by standard but not tested N/T not required by standard N/R test object does meet the requirement P(PASS) test object does not meet the requirement F(FAIL) Testing: Test Lab Temperature 20 °C - 30 °C Test Lab Humidity 25 % - 55 % Date of performance 2024-08-30 Date of receipt of test item See test sample identification table on page 6 Report: Compiled by Stephan Liebich Tested by (+ signature) (Responsible for Test) Stephan Liebich ....................................................... Approved by (+ signature) (Test Lab Engineer) Radwan Jaafar ....................................................... Date of Issue 2024-09-05 Total number of pages 17 General Remarks: The test results presented in this report relate only to the object tested. The results contained in this report reflect the results for this particular model and serial number. It is the responsibility of the manufacturer to ensure that all production models meet the intent of the requirements detailed within this report. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. Additional Comments: None Test Report No.: G0M-2311-2313-TFC093PE-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 17 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2024-08-13 Initial Release -- 02 2024-08-30 Replaced document: G0M-2311-2313-TFC093PE-V01 Replaced by: G0M-2311-2313-TFC093PE-V02 Changes: • Add of LE 1M PHY and LE 2M PHY • Re-calculation Page 8: • Add of SAR test exclusion power threshold acc. to FCC KDB 447498 D01 Page 15: • Add of Duty Cycle Plots St. Liebich Test Report No.: G0M-2311-2313-TFC093PE-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 17 ABBREVIATIONS AND ACRONYMS Acronyms Acronym Description EIRP Equivalent Isotropic Radiated Power ERP Effective Radiated Power EUT Equipment Under Test LPE Low Power Exclusion Test Report No.: G0M-2311-2313-TFC093PE-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 17 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Reference Documents ................................................................................................................................... 7 1.2 Standalone radiation sources ........................................................................................................................ 8 1.3 Concurrent Sources ...................................................................................................................................... 8 2 Result Summary ................................................................................................................................. 9 3 RF-Exposure classification ............................................................................................................ 10 4 RF-Exposure limits and exclusion thresholds ............................................................................ 11 4.1 SAR limits .................................................................................................................................................... 11 4.2 SAR standalone test exclusion threshold .................................................................................................... 11 4.3 SAR concurrent test exclusion threshold ..................................................................................................... 12 5 RF-Exposure Evaluation ................................................................................................................. 13 6 Single Source Evaluation Results - FCC ...................................................................................... 14 ANNEX A Duty Cycle Plots ............................................................................................................................... 15 Test Report No.: G0M-2311-2313-TFC093PE-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 17 1 Equipment (Test Item) Under Test Description IDA0097 Auto-lnjector Model IDA0097 Auto-lnjector, Model 02 Additional Model(s) None Brand Name(s) None Sample Identification EUT # Sample-ID Serial Number Date of receipt EUT 1 48528 24030040002450 2024-05-15 Hardware Version(s) 2089879486 Software Version(s) 11.04.00 FCC ID 2AAGY-SKYT2 Equipment type End Product Environment General public Use case Extremities Test Report No.: G0M-2311-2313-TFC093PE-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 17 1.1 Reference Documents Document Type Document No. Issued by Date RADIO REPORT G0M-2311-2313- TFC247BL-V02 Eurofins Product Service GmbH 2024-09-05 Test Report No.: G0M-23…

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Test Report

Test Report No.: G0M-2311-2313-TFC247BL-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 88 RADIO REPORT FCC 47 CFR Part 15C Digital transmission systems operating within the 2400.0 MHz - 2483.5 MHz band Report Reference No G0M-2311-2313-TFC247BL-V02 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Accreditation DAkkS - Registration number : D-PL-12092-01-04 (FCC) FCC Filed Test Laboratory, Reg.-No.: 96970 Applicant Phillips-Medisize A/S Address Gimsinglundvej 20 7600 Struer DENMARK Test Specification 47 CFR Part 15C Non-Standard Test Method None Equipment under Test (EUT): Product Description IDA0097 Auto-lnjector Model(s) IDA0097 Auto-lnjector, Model 02 Additional Model(s) None Brand Name(s) None Hardware Version(s) 2089879486 Software Version(s) 11.04.00 FCC ID 2AAGY-SKYT2 Test Result PASSED Test Report No.: G0M-2311-2313-TFC247BL-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 2 of 88 Possible test case verdicts: Required by standard but not tested N/T Not required by standard N/R Not applicable to EUT N/A Test object does meet the requirement P(PASS) Test object does not meet the requirement F(FAIL) Testing: Test Lab Temperature 20 °C - 30 °C Test Lab Humidity 25 % - 55 % Date of receipt of test item 2024-05-14 Report: Compiled by Md Abu Bakar Siddique Tested by (+ signature) (Responsible for Test) Md Abu Bakar Siddique Approved by (+ signature) (Test Lab Engineer) Florian Voigt Date of Issue 2024-09-05 Total number of pages 88 General Remarks: The test results presented in this report relate only to the object tested. The results contained in this report reflect the results for this particular model and serial number. It is the responsibility of the manufacturer to ensure that all production models meet the intent of the requirements detailed within this report. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. Additional Comments: RF module shall be shut down when EUT is connected to AC power. Test Report No.: G0M-2311-2313-TFC247BL-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 88 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2024-08-06 Initial Release -- 02 2024-09-05 Replaced document: G0M-2311-2313-TFC247BL-V01 Replaced by: G0M-2311-2313-TFC247BL-V02 Changes: • Updated antenna gain with measured value. • Added 2 Mbps mode measurement results. Siddique Test Report No.: G0M-2311-2313-TFC247BL-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 88 ABBREVIATIONS AND ACRONYMS Acronyms Acronym Description EUT Equipment Under Test FCC Federal Communications Commission ISED Innovation, Science and Economic Development Canada RBW Resolution bandwidth RMS Root mean square VBW Video bandwidth VNOM: Nominal supply voltage Test Report No.: G0M-2311-2313-TFC247BL-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 88 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Photos – Equipment External ........................................................................................................................ 7 1.2 Photos – Equipment Internal ......................................................................................................................... 9 1.3 Support Equipment ...................................................................................................................................... 11 1.4 Test Modes ................................................................................................................................................. 12 1.5 Test Frequencies ......................................................................................................................................... 13 1.6 Sample emission level calculation ............................................................................................................... 14 2 Result Summary ............................................................................................................................... 15 3 Test Conditions and Results .......................................................................................................... 16 3.1 Test Conditions and Results - 6 dB bandwidth ............................................................................................ 16 3.2 Test Conditions and Results - Maximum peak conducted output power ..................................................... 24 3.3 Test Conditions and Results - Power spectral density ................................................................................ 32 3.4 Test Conditions and Results - Band-edge compliance ................................................................................ 40 3.5 Test Conditions and Results - Conducted spurious emissions .................................................................... 46 3.6 Test Conditions and Results - Transmitter radiated emissions ................................................................... 54 ANNEX A Transmitter spurious emissions ....................................................................................................... 61 Test Report No.: G0M-2311-2313-TFC247BL-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 88 1 Equipment (Test Item) Under Test Description IDA0097 Auto-lnjector Model IDA0097 Auto-lnjector, Model 02 Additional Model(s) None Brand Name(s) None Sample Identification EUT # Sample-ID Serial Number EUT 1 48528 24030040002450 Hardware Version(s) 2089879486 Software Version(s) 11.04.00 FCC ID 2AAGY-SKYT2 Equipment type End Product Radio type Transceiver Assigned frequency …

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Test Report

Test Report No.: G0M-2311-2313-TFCAUT-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 19 ANTENNA TEST REPORT Antenna operating within the 2400 MHz – 2483.5 MHz band Report Reference No G0M-2311-2313-TFCAUT-V01 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Applicant Phillips-Medisize A/S Address Gimsinglundvej 20 7600 Struer DENMARK Equipment under Test (EUT): Product Description IDA0097 Auto-lnjector Model(s) IDA0097 Auto-lnjector, Model 02 Additional Model(s) None Brand Name(s) None Hardware Version(s) 2089879486 Software Version(s) 11.04.00 FCC ID 2AAGY-SKYT2 Test Report No.: G0M-2311-2313-TFCAUT-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 2 of 19 Testing: Test Lab Temperature 20 °C - 30 °C Test Lab Humidity 25 % - 55 % Date of receipt of test item 2024-08-21 Report: Compiled by Md Abu Bakar Siddique Tested by (+ signature) (Responsible for Test) Md Abu Bakar Siddique Approved by (+ signature) Wilfried Treffke ....................................................... Date of Issue 2024-09-09 Total number of pages 19 General Remarks: The test results presented in this report relate only to the object tested. The results contained in this report reflect the results for this particular model and serial number. It is the responsibility of the manufacturer to ensure that all production models meet the intent of the requirements detailed within this report. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. Additional Comments: -- Test Report No.: G0M-2311-2313-TFCAUT-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 19 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2024-09-05 Initial Release -- Test Report No.: G0M-2311-2313-TFCAUT-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 19 ABBREVIATIONS AND ACRONYM…

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Contact Information

Applicant

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

Technical Contact

Phillips-Medisize A/SAbel Arredondo
[email protected]+45 28 40 51 72

Gimsinglundvej 20 · Struer · Denmark

Non-Technical Contact

Phillips-Medisize A/S
[email protected]+45 42125899

Test Firm

Eurofins Product Service GmbHMichael Howard
[email protected]49-33631-888-300Fax: 49-33631-888-650

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz4.70 mW
Confidentiality
Long Term
Grant Notes
Output power is listed as conducted.

Other Applications from 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
2AAGY-BETAC1

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.

Nov 26, 2013

Equipment Class

DTS - Digital Transmission System