2AYGA2032CUBE

Rx only 2021-Feb Pain Therapy 疼痛療法 NeuroBlock Spinal Cord Stimulation System NeuroBlock 脊髓電刺激系統 Models 1001, 1401, 2032 型號1001, 1401, 2032 User Manual 使用者手冊 2021-Feb M203210201V1.3 English 1 Label Symbols Explanation of symbols on products and packaging. Refer to the appropriate product for symbols that apply. i Consult instructions for use xx°C xx°F xx°C xx°F Temperature limitation Use by Manufacturer Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. Magnetic Resonance (MR) Unsafe. Serial number Keep dry IEC60601-1/EN60601-1, Type BF equipment Non-ionizing electromagnetic radiation Authorized Representative in the European Community GIMER Medical is a trademark of GiMER Medical Co. Ltd., registered in the U.S. and other countries. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by GiMER Medical is under license. FCC Information The following is communications regulation information on the Model 1001 External Stimulator. N 2 English M203210201V1.3 2021-Feb FCC ID: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. 2021-Feb M203210201V1.3 English 3 Table of Contents Label Symbols ........................................................................... 1 Table of Contents ...................................................................... 3 1 INTRODUCTION ................................................................... 5 How to use this manual ......................................................... 5 Patient Identification Card ...................................................... 6 2 IMPORTANT THERAPY INFORMATION............................. 7 Purpose of the device ............................................................ 7 Purpose of the spinal cord stimulation (SCS) system (indications) ........................................................................... 7 Description of your system .................................................... 7 Therapies that may not be used with the SCS system (contraindications) ................................................................. 9 Risks and benefits ................................................................. 9 Risks of surgery ..................................................................... 9 General Warnings .................................................................. 9 Precautions .......................................................................... 13 Individualization of treatment ............................................... 15 3 RECOVERY AND CARE AFTER SURGERY ..................... 16 Recovery from surgery ........................................................ 16 Activities .............................................................................. 16 When to call your clinician ................................................... 17 Care schedule ...................................................................... 17 4 USING YOUR CUBE .......................................................... 18 How your Cube works .......................................................... 18 Cube function keys and indicators ....................................... 19 Turn on and off the Cube ..................................................... 23 Cube power status ............................................................... 24 Recharging Cube ................................................................. 25 Reboot the Cube .................................................................. 26 5 USING CUBE TO START STIMULATION DURING TRIAL PHASE ................................................................................ 27 6 USING CUBE TO START STIMULATION DURING PERMANENT IMPLANTATION PHASE ............................ 31 7 TROUBLESHOOTING ........................................................ 37 8 ADDITIONAL INFORMATION ............................................ 40 Adverse events .................................................................... 40 4 English M203210201V1.3 2021-Feb Possible system complications ............................................ 41 9 MAINTAINENCE AND ASSISTANCE ................................ 42 Cleaning and care ................................................................ 42 Safety and technical checks ................................................. 42 Battery, Cube, and External Stimulator disposal .................. 42 Implantable Receiver disposal ............................................. 42 Specifications ....................................................................... 43 User assistance ................................................................... 44 2021-Feb M203210201V1.3 English 5 1 INTRODUCTION How to use this manual Use this manual during trial phase and after receiving an Implantable Receiver. Ask your clinician to explain anything that is unclear. ▪ "1 INTRODUCTION", describes how to use this manual and information about the patient identification card. ▪ "2 IMPORTANT THERAPY INFORMATION", describes when you should and should not use a spinal cord stimulation system, the spinal cord stimulation system components, and the risks, benefits, warnings, precautions, and patient activities related to your spinal cord stimulation system. ▪ "3 RECOVERY AND CARE AFTER SURGERY", provides information about recovering from surgery, activity and care information, and when to contact your clinician. ▪ "4 USING YOUR CUBE", DESCRIBES THE CUBE, how to control and recharge the Cube. ▪ "5 USING CUBE TO START STIMULATION DURING TRIAL PHASE", describes how to adjust your stimulation using your Cube during trial phase. ▪ "6 USING CUBE TO START STIMULATION DURING PERMANENT IMPLANTAT…

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Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 2 of 35 External Photos Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 3 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 4 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 5 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 6 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 7 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 8 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 9 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 10 of 35 Peripheral: 1001 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 11 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 12 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 13 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 14 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 15 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 16 of 35

TITLE: DRAWN:DATE CHECKED: GiMerMed. CO., Ltd. TAIWAN, R.O.C. TEL: +886-2-26972680 DWG No:REV. THESEDRAWINGSANDSPECIFICATIONSARETHESOLEPROPERTYOFGIMERMEDICALCO., LTD.,ANDSHALLNOTBEREPRODUCED,COPIED,ORUSEDINANYMANNERWITHOUTTHE PRIORWRITTENCONSENTOFGIMERMEDICALCO.,LTD.ORITSAFFILIATEDSUBSIDIARIES. APPROVED: SHEET 1/ CUBECASELABEL 6-2032-DCL-101 0.2 CY CHENG26//01/2021 1

Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 17 of 35 Internal Photos Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 18 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 19 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 20 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 21 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 22 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 23 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 24 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 25 of 35 Peripheral: 1001 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 26 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 27 of 35 Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 28 of 35

of Applicant: Gimer medical co.,Ltd Address: 9F.-5 and -6, No.97, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221, Taiwan Tested and Prepared by Worldwide Testing Services (Taiwan) Co., Ltd. FCC Registration No.: TW1477, TW0020, TW1072 Industry Canada filed test laboratory Reg. No. 20037 Report No.: W6M22003-19790-C-1 6F, NO. 58, LANE 188, RUEY-KUANG RD., NEIHU TAIPEI 114, TAIWAN, R.O.C. TEL: 886-2-66068877 FAX: 886-2-66068879 E-mail: [email protected] 47 CFR PART 15 SUBPART C TEST REPORT for CUBE Model No.: 2032 FCC ID: 2AYGA2032 Registration number: W6M22003-19790-C-1 FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Page 1 of 19 TABLE OF CONTENTS 1 GENERAL INFORMATION .......................................................................................................... 2 1.1 NOTES .......................................................................................................................................... 2 1.2 TESTING LABORATORY ................................................................................................................ 3 1.2.1 Location .................................................................................................................................. 3 1.2.2 Details of accreditation status ................................................................................................ 3 1.3 D ETAILS OF APPROVAL HOLDER ................................................................................................... 3 1.4 APPLICATION DETAILS ................................................................................................................. 4 1.5 G ENERAL INFORMATION OF TEST ITEM ........................................................................................ 4 1.6 T EST STANDARDS ......................................................................................................................... 4 2 TECHNICAL TEST ......................................................................................................................... 5 2.1 SUMMARY OF TEST RESULTS ........................................................................................................ 5 2.2 TEST ENVIRONMENT .................................................................................................................... 5 2.3 TEST EQUIPMENT LIST ................................................................................................................. 6 2.4 G ENERAL TEST PROCEDURE ........................................................................................................ 9 3 TEST RESULTS (ENCLOSURE) ................................................................................................ 11 3.1 OUTPUT POWER (FIELD STRENGTH) .......................................................................................... 12 3.2 OUT OF BAND RADIATED EMISSIONS ......................................................................................... 13 3.3 OCCUPIED BANDWIDTH ............................................................................................................. 15 3.4 F REQUENCY TOLERANCE ........................................................................................................... 16 3.5 POWER LINE CONDUCTED EMISSION ......................................................................................... 17 A PPENDIX .............................................................................................................................................. 19 Registration number: W6M22003-19790-C-1 FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Page 2 of 19 1 General In formation 1.1 Notes The purpose of conformity testing is to increase the probability of adherence to the essential requirements or conformity specifications, as appropriate. The complexity of the technical specifications, however, means that full and thorough testing is impractical for both technical and economic reasons. Furthermore, there is no guarantee that a test sample which has passed all the relevant tests conforms to a specification. Neither is there any guarantee that such a test sample will interwork with other genuinely open systems. The existence of the tests nevertheless provides the confidence that the test sample possesses the qualities as maintained and that is performance generally conforms to representative cases of communications equipment. The test results of this test report relate exclusively to the item tested as specified in 1.5. The test report may only be reproduced or published in full. Reproduction or publication of extracts from the report requires the prior written approval of the Worldwide Testing Services(Taiwan) Co., Ltd. Tester: February 09, 2021 Spencer Yang Date WTS-Lab. Name Signature Technical responsibility for area of testing: Feb ruary 09, 2021 Kevin Wang Date WTS Name Signature Registration number: W6M22003-19790-C-1 FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Page 3 of 19 1.2 Testing laboratory 1.2.1 Location OATS No.5-1, Lishui, Shuang Sing Village, Wanli Dist., New Taipei City 207, Taiwan (R.O.C.) 3 meter semi-anechoic chamber No.35, Aly. 21, Ln. 228, Ankang Rd., Neihu Dist., Taipei City 114, Taiwan (R.O.C.) TEL:886-2-6613-0228 FAX:886-2-2791-5046 Company Worldwide Testing Services(Taiwan) Co., Ltd. 6F, NO. 58, LANE 188, RUEY-KUANG RD. NEIHU, TAIPEI 114, TAIWAN R.O.C. Tel : 886-2-66068877 Fax : 886-2-66068879 1.2.2 Details of accreditation status Accredited testing laboratory FCC filed test laboratory Reg. No. TW1477, TW0020, TW1072 Industry Canada filed test laboratory Reg. No. 20037 Test location, where different from Worldwide Testing Services (Taiwan) Co., Ltd. : Name: ./. Accredited number: ./. Street: ./. Town: ./. Country: ./. Telephone: ./. Fax: ./. 1.3 Details of approval holder Name: Street: City: Country: Telephone: Fax: Gimer medical co.,Ltd 9F.-5 and -6, No.97, Sec. 1, Xintai 5th Rd., Xizhi Dist…

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Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 29 of 35 Set Up Photo of Radiated Emission EMI Battery Below 30MHz Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 30 of 35 30-1000MHz Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 31 of 35 Above 1GHz Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 32 of 35 Charge Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 33 of 35 RF Below 30MHz Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 34 of 35 Above 30MHz Registration number: W6M22003-19790-FCC FCC ID: 2AYGA2032 Worldwide Testing Services(Taiwan) Co., Ltd. Appendix page 35 of 35 Set Up Photo of Conducted Emission