2BOED-SMHEXMedical Controller with BLE

Hoffmann LRF ® smartHEX™ Strut Controller and Mobile Application User Manual Contents 1. Introduction a. Indications for Use b. Use Environment c. Contraindications d. Warnings e. Cautions f. Safety information i. Explanation of symbols on labels 2. Product Overview a. HexConnect Mobile Application b. Hoffmann LRF smartHEX Strut Controllers i. smartHEX Strut Controller Kit c. Strut controller features 3. User Instructions a. Setting up the strut controllers i. Battery insertion ii. Strut controller activation iii. Strut controller battery status iv. Battery replacement b. Mounting the strut controllers i. Attaching ID caps c. Using the HexConnect Mobile Application i. Setting up the app 1. Welcome message receipt 2. Downloading the HexConnect Mobile Application 3. Linking the correction plan 4. When the application opens: a. End User License Agreement b. Enable Notifications c. Enable Bluetooth® 5. Open the correction plan ii. Enrolling the strut controllers 1. Enrollment steps: a. Automatic: b. Manual: 2. Enroll the remaining strut controllers 3. Replace enrollment 4. Exchanging a strut controller 5. Lock enrollment iii. Navigating the app 1. Main menu 2. Controller Connectivity 3. Correction Plan 4. Controller Details 5. Deformity Details 6. Frame simulation 7. Settings a. Reminder Notifications b. Product Information c. Terms and conditions d. Executing the correction plan i. Access the scheduled correction ii. Strut correction reminders iii. Navigating the app 1. Main menu 2. Controller connectivity 3. Correction plan 4. Controller details 5. Deformity details 6. Frame simulation 7. Settings a. Product information b. Reminder notifications c. Terms and conditions iv. Performing a correction 1. Pausing or stopping a correction plan a. Pause function b. Stop function v. Managing missed corrections 1. Missing consecutive days 4. Indications and errors 5. Instructions for mobile app users 6. Cybersecurity 7. Connecting the device to a network 8. FCC compliance statement 9. FCC caution 10. Strut controller specifications a. Weight and dimensions b. Storage conditions c. Operating conditions d. Accuracy e. Battery f. Device transmitter 11. Cleaning instructions 12. Discretionary strut controller removal 13. Device disposal 14. Electromagnetic compatibility (EMC) 15. Guidance and manufacturer’s declaration electromagnetic emissions For smartHEX, HexConnect or Hoffmann LRF Hexapod assistance, contact Stryker OR Assist Customer Service at: +1 (844) 393-4933 For non-urgent requests, contact the Hoffmann LRF helpdesk via email at: [email protected] Introduction The Hoffmann LRF smartHEX platform is designed to guide patients through the recovery process following surgical application of an external �ixation device by automatically performing the necessary corrections at the appropriate times, as prescribed by a surgeon. The Hoffmann LRF smartHEX platform consists of an external �ixation device, smartHEX struts and strut controllers, and the HexConnect Mobile Application. The smartHEX strut controllers are attached to the smartHEX struts, and the HexConnect mobile application pairs with the strut controllers. Once enrolled, the strut controllers can adjust the frame according to the prescribed correction plan by using wireless control commands from the HexConnect mobile app. The prescribing surgeon may access correction data through the Hoffmann LRF smartHEX Web Application (for healthcare providers only). Indications for use The Stryker Hoffmann LRF System is indicated in pediatric and adult patients for the treatment and �ixation of: • Open and closed fractures • Post-traumatic joint contracture which has resulted in loss of range of motion • Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction • Pseudoarthrosis or non-union of long bones • Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction • Correction of bony or soft tissue deformity • Correction of segmental bony or soft tissue defects • Joint arthrodesis • Management of comminuted intra- articular fractures of the distal radius • Bone transport The Hoffmann LRF System is indicated in adults for: • Osteotomy • Revision procedure where other treatments or devices have been unsuccessful • Bone reconstruction procedures • Fusions and replantations of the foot • Charcot foot reconstruction • Lisfranc dislocations Use environment The Hoffmann LRF smartHEX platform is a prescription device that is intended for use in accordance with the directions of a healthcare provider. The device is intended to be used in a professional or home health-care environment by the patient or homecare p r o v i d e r. Contraindications Since external �ixation devices are often used in emergency situations to treat patients with acute injuries, there are no absolute contraindications for use. The surgeon’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment for each individual patient. Whenever possible, the device chosen should be of a type indicated for the fracture being treated and/or for the procedure being utilized. Conditions presenting an increased risk of failure include: • Insuf�icient quantity or quality of bone which would inhibit appropriate �ixation of the device • Compromised vascularity that would inhibit adequate blood supply to the fracture or operative site • Previous history of infections • Any neuromuscular de�icit which could interfere with the patient’s ability to limit weight bearing • Any neuromuscular de�icit which places an unusually heavy load on the device during the healing period • Malignancy in the fracture area • Mental, physical or neurological conditions which may impair the patient’s ability to cooperate with the postoperative regimen Warnings • Always use smartHEX strut controllers as directed. The smartHEX strut controllers, in conjunction with the HexConnect mo…

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Photos internal Stryker Internal views: Antenna

The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH File No. 80242473-04 Rev_1, page 1 of 11 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360  Fax:+49(0)9931-9836440 Rev. No. 6.4, 2024-07-01 CSA Confidential R F − T E S T R E P O R T - Human Exposure - Type / Model Name : Hoffmann LRF smart controller Product Description : Medical Controller with BLE Applicant : Stryker Trauma & Extremities Address : 325 Corporate Drive 07430 Mahwah, New Jersey, United States Manufacturer : Stryker Trauma & Extremities Address : 325 Corporate Drive 07430 Mahwah, New Jersey, United States Test Result according to the standards listed in clause 1 test standards: POSITIVE Test Report No. : 80242473-04 Rev_1 10. December 2025 ________________________________________________________________ ___________ ____________ _______ Date of issue The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH File No. 80242473-04 Rev_1, page 2 of 11 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360  Fax:+49(0)9931-9836440 Rev. No. 6.4, 2024-07-01 CSA Confidential Contents 1 T E S T S T A N D A R D S 3 2 E Q U I P M E N T U N D E R T E S T 4 2.1 Information provided by the Client 4 2.2 Sampling 4 2.3 Photo documentation of the EUT – See ATTACHMENT A 4 2.4 Equipment type 4 2.5 Short description of the equipment under test (EUT) 4 2.6 Variants of the EUT 4 2.7 Operation frequency and channel plan 5 2.8 Transmit operating modes 5 2.9 Antennas 5 2.10 Power supply system utilised 5 3 T E S T R E S U L T S U M M A R Y 6 3.1 Revision history of test report 6 3.2 Final assessment 6 4 T E S T E N V I R O N M E N T 7 4.1 Address of the test laboratory 7 4.2 Environmental conditions 7 4.3 Statement of the measurement uncertainty 7 4.4 Conformity Decision Rule 7 5 T E S T C O N D I T I O N S A N D R E S U L T S 8 5.1 RF output power 8 6 H U M A N E X P O S U R E 9 6.1 FCC SAR test exclusion considerations 9 6.2 RSS Exemption limits for routine evaluation - SAR evaluation 10 ATTACHMENT A as separate supplement The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH File No. 80242473-04 Rev_1, page 3 of 11 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360  Fax:+49(0)9931-9836440 Rev. No. 6.4, 2024-07-01 CSA Confidential 1 T E S T S T A N D A R D S The tests were perf ormed according to f ollowing standards: FCC Rules and Regulations Part 1, Subpart I - Procedures Implementing the National Environmental Policy Act of 1969 Part 1, Subpart I, Section 1.1310 Radiof requency radiation exposure limits Part 1, Subpart 2, Section 2.1091 Radiofrequency radiation exposure evaluation: mobile devices. Part 1, Subpart 2, Section 2.1093 Radiofrequency radiation exposure evaluation: portable devices. KDB 447498 D01 V06 RF Exposure procedures and equipment authorisation policies for mobile and portable devices. ANSI C95.1: 2005 IEEE Standard for Safety Levels with respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz RSS-102, Issue 6 Radio Frequency (RF) Exposure Compliance of Radiocommunication Apparatus (All Frequency Bands) The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH File No. 80242473-04 Rev_1, page 4 of 11 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360  Fax:+49(0)9931-9836440 Rev. No. 6.4, 2024-07-01 CSA Confidential 2 E Q U I P M E N T U N D E R T E S T 2.1 Information provided by the Client Please note, we do not take any responsibility for information provided by the client or his representative which may have an inf luence on the validity of the test results. 2.2 Sampling The customer is responsible for the choice of sample. Sample configuration, start-up and operation is carried out by the customer or according his/her instructions. 2.3 Photo documentation of the EUT – See ATTACHMENT A 2.4 Equipment type BLE device 2.5 Short description of the equipment under test (EUT) HLRF Smart Hexapod Controller is an electromechanical device which is mounted on a strut component of HLRF Smart Hexapod frame and provides actuation to strut. The Controller module has BLE interf ace to interact with Mobile App and exchange data. The modulation of the BLE used by the EUT is GFSK with a data rate of 1 Mbit/s. Number of tested samples : 1 (radiated sample) 1 (conducted sample) Serial number : 100348 100380 Firmware number : SC_RF_V_01.01B SC_RF_V_01.01B FCC ID : 2BOED-SMHEX IC ID : 33821-SMHEX HVIN : 4938-0-500 Items Description BT type 5.2 Low Energy BT chipset type nRF52832 Modulation GFSK Frequency range 2400 MHz to 2483.5 MHz Channel numbers 40 Data rate (Mbps) 1 Power setting Def ault (0) Antenna type PCB 2.6 Variants of the EUT There are no variants. The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH File No. 80242473-04 Rev_1, page 5 of 11 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360  Fax:+49(0)9931-9836440 Rev. No. 6.4, 2024-07-01 CSA Confidential 2.7 Operation frequency and channel plan The operating f requency is 2400 MHz to 2483.5 MHz. 2.8 Transmit operating modes The EUT uses DSSS modulation. 2.9 Antennas The f ollowing antennas shall be used with the EUT: 2.10 Power supply system utilised Power supply voltage, V nom : 3 V DC (battery powered) Number Characteristic f -range (GHz) Gain (dBi) 1 Omni 2.4 - 2…

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The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 1 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential Address: CSA Group Bayern GmbH Straubinger Straße 100 94447 Plattling GERMANY Phone +49(0)9931-98360 E - mail [email protected] Internet: http://www.csagroup.org Test – Results Order-No.: 80270285-00 Rev_0 Client Stryker Trauma & Emtremities, 325 Corporat Drive, Mahwah, 07430 NEW JERSEY, U.S.A Manufacturer Stryker Trauma & Emtremities, 325 Corporat Drive, Mahwah, 07430 NEW JERSEY, U.S.A Product Description BLE antenna Type / Model Name Hoffmann LRF Smart Hexapod Controller/ REF 4938-0-500 Testing commenced on 2025-11-18 Pretest is made according to Customer specific Testing concluded on 2025-11-18 Serial - No. PCB SN 211 Remarks: Customer specific tests in order to determine antenna gain and antenna performance. This test result consists of 15 page(s). The test result only corresponds to the tested sample. It is not permitted to copy extracts of these test results without the written permission of the test laboratory. Date Checked by Tested by Result 2025-12-15 Not applicable, no standards used The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 2 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential Photo documentation and setup description Measurements are performed with a 3-meter test setup in fully anechoic room FAR1. Height of EUT: 1.5 m Height of receiving antenna: 1.5 m Test distance: 3.0 m Polarisation of receiving antenna horizontal and vertical Measured frequencies: 2402 MHz,2440 MHz, 2480 MHz Output power of signal generator -10.0 dBm Attenuator and cable loss 10.6 dB for all frequencies Power at antenna -20.6 dBm for all frequencies test setup: The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 3 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential Photo documentation of EUTs The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 4 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential The turntable is rotated counterclockwise. This leads to the following relationship in the polar plots of the test result graphs: EUT X EUT Y EUT Z 0° 90° 180° 270° 0° 90° 180° 270° 0° 90° 180° 270° The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 5 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential Test results for test instruments and accessories used see CPR 3 Peak gain overview Peak Gain (dBi) EUT X horizontal EUT X vertical EUT Y horizontal EUT Y vertical EUT Z horizontal EUT Z vertical 2402 MHz -6.3 -14.5 -11.9 -12.6 -10.0 -12.1 2440 MHz -5.7 -14.0 -10.5 -11.1 -9.1 -10.4 2480 MHz -6.1 -12.8 -10.1 -10.9 -8.4 -10.8 The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 6 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential Detailed graphical representation EUT X, 2402 MHz, horizontal EUT X, 2402 MHz, vertical The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 7 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential EUT X, 2440 MHz, horizontal EUT X, 2440 MHz, vertical The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 8 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential EUT X, 2480 MHz, horizontal EUT X, 2480 MHz, vertical The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 9 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential EUT Y, 2402 MHz, horizontal EUT Y, 2402 MHz, vertical The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH Order No.: 80270285-00 Rev_0, Page 10 of 15 Straubinger Straße 100  94447 Plattling  GERMANY Tel.:+49(0)9931-98360 Rev. Nr. 3.6 2020-02-12 CSA Confidential EUT Y, 2440 MHz, horizontal EUT Y, 2440 MHz, vertical The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laborator…

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The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . CSA Group Bayern GmbH File No. 80242473-03 Rev_1, page 1 of 37 Straubinger Strasse 100  94447 PLATTLING  GERMANY Tel.: +49(0)9931-98360 Rev. No. 7.2 2024-07-02 R F − T E S T R E P O R T - FCC Part 15.247, RSS-247 - Model Name : Hoffmann LRF smart controller Product Description : Medical Controller with BLE Applicant : Stryker Trauma & Extremities Address : 325 Corporate Drive 07430 Mahwah, New Jersey, United States Manufacturer : Stryker Trauma & Extremities Address : 325 Corporate Drive 07430 Mahwah, New Jersey, United States Test Result according to the standards listed in clause 1 test standards: POSITIVE Test Report No. : 80242473-03 Rev_1 10. December 2025 ________________________________________________________________ ___________ ____________ _______ Date of issue The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . : CSA Group Bayern GmbH File No. 80242473-03 Rev_1, page 2 of 37 Straubinger Strasse 100  94447 PLATTLING  GERMANY Tel.: +49(0)9931-98360 Rev. No. 7.2 2024-07-02 Contents 1 T E S T S T A N D A R D S 3 2 E Q U I P M E N T U N D E R T E S T 4 2.1 Information provided by the Client 4 2.2 Sampling 4 2.3 General remarks 4 2.4 Photo documentation of the EUT – Detailed photos see ATTACHMENT A 4 2.5 Equipment type 4 2.6 Short description of the equipment under test (EUT) 4 2.7 Variants of the EUT 5 2.8 Operation frequency and channel plan 5 2.9 Transmit operating modes 5 2.10 Antenna 5 2.11 Power supply system utilised 5 2.12 Peripheral devices and interface cables 6 2.13 Determination of worst-case conditions for final measurement 6 3 T E S T R E S U L T S U M M A R Y 7 3.1 Revision history of test report 7 3.2 Final assessment 7 4 T E S T E N V I R O N M E N T 8 4.1 Address of the test laboratory 8 4.2 Environmental conditions 8 4.3 Statement of the measurement uncertainty 8 4.4 Conformity Decision Rule 9 4.5 Measurement protocol for FCC and ISED 9 5 T E S T C O N D I T I O N S A N D R E S U L T S 12 5.1 EBW and OBW 12 5.2 Maximum peak conducted output power 16 5.3 Power spectral density 20 5.4 Spurious emissions radiated 23 5.5 Antenna application 35 6 U S E D T E S T E Q U I P M E N T A N D A C C E S S O R I E S 36 ATTACHMENTs A, B as separate supplements The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . : CSA Group Bayern GmbH File No. 80242473-03 Rev_1, page 3 of 37 Straubinger Strasse 100  94447 PLATTLING  GERMANY Tel.: +49(0)9931-98360 Rev. No. 7.2 2024-07-02 1 T E S T S T A N D A R D S The tests were perf ormed according to f ollowing standards: FCC Rules and Regulations Part 15 (November 2025) Part 15, Subpart A General Part 15, Subpart C, Section 15.247 Operation within the bands 902 - 928 MHz, 2400 - 2483.5 MHz and 5725 - 5850 MHz ANSI C63.10-2020 + Cor. 1-2023 + Testing Unlicensed Wireless Devices C63.10a-2024 + Errata to C63.10a-2024 KDB 558074 D01 v05r02 Guidance for compliance measurements on DTS; FHSS and hybrid system devices operating under Section 15.247 of the FCC rules, April 2, 2019. ISED Canada Rules and Regulations RSS-Gen, Issue 5 + Amendment 1 + 2 General Requirements f or Compliance of Radio Apparatus RSS-247, Issue 4 Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and Licence-Exempt Local Area Network (LE- LAN) Devices ANSI C63.10-2020 + Cor. 1-2023 + Testing Unlicensed Wireless Devices C63.10a-2024 + Errata to C63.10a-2024 KDB 558074 D01 v05r02 Guidance for compliance measurements on DTS; FHSS and hybrid system devices operating under Section 15.247 of the FCC rules, April 2, 2019. The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permissi on of the test laboratory . : CSA Group Bayern GmbH File No. 80242473-03 Rev_1, page 4 of 37 Straubinger Strasse 100  94447 PLATTLING  GERMANY Tel.: +49(0)9931-98360 Rev. No. 7.2 2024-07-02 2 E Q U I P M E N T U N D E R T E S T 2.1 Information provided by the Client Please note, we do not take any responsibility for information provided by the client or his representative which may have an inf luence on the validity of the test results. 2.2 Sampling The customer is responsible for the choice of sample. Sample configuration, start-up and operation is carried out by the customer or according his/her instructions. 2.3 General remarks None 2.4 Photo documentation of the EUT – Detailed photos see ATTACHMENT A 2.5 Equipment type BLE device 2.6 Short description of the equipment under test (EUT) HLRF Smart Hexapod Controller is an electromechanical device which is mounted on a strut component of HLRF Smart Hexapod frame and provides actuation to strut. The Controller module has BLE interf ace to interact with Mobile App and exchange data. The modulation of the BLE used by the EUT is GFSK with a data rate of 1 Mbit/s. Number of tested samples : 1 (radiated sample) 1 (conducted sample) Serial number : 100348 100380 Firmware number : SC_…

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