2AARUFM007Wireless USB stick

TH E E MEDTRUM PP RODUCT Insu l Pat l in Man a M D Us e chTrum a geme n D ‐ SY ‐ 007 e r Guide n t Syste m Medtrum Tech n Unit 7F, BuildinShanghai 2012 0 China Te l +86 ‐ 21 ‐ 5 0 Fax +86 ‐ 21 ‐ 5 0 www.medtru m m n ologies Inc. g 8, No.200 Niud u 0 3 0 274781 0 274779 m .com u n Road 1 Contents Contents ...................................................................................................................... ......................................................... 1 Introduction .................................................................................................................. ....................................................... 4 Before you begin .............................................................................................................. .............................................4 Indications ................................................................................................................... .................................................4 Contraindications ............................................................................................................. .............................................4 Warnings, precautions and impo rtant safety information ........................................................................ ......................5 Warnings ...................................................................................................................... .................................................... 5 Precautions ................................................................................................................... ................................................... 5 X ‐ rays, MRIs and CT scans ....................................................................................................... ......................................... 8 Consumables ................................................................................................................... ................................................. 8 About radio frequency (RF) communication ...................................................................................... ............................. 8 Emergency kit ................................................................................................................. ................................................. 9 Avoid extreme temperature ..................................................................................................... ..................................... 10 Water and your Patch .......................................................................................................... .......................................... 10 Storage ....................................................................................................................... .................................................... 10 The basics .................................................................................................................... ....................................................... 11 Introduction to insu lin pump therapy .......................................................................................... ................................ 11 How does the sy stem work? ..................................................................................................... ................................... 11 Key features .................................................................................................................. .............................................. 13 No tubing ..................................................................................................................... .................................................. 13 Automated cannula insertion ................................................................................................... ..................................... 14 A fully ‐ integrated design ............................................................................................................. ................................... 14 Bolus guide.................................................................................................................... ................................................. 14 Record keeping ................................................................................................................ .............................................. 14 Event capturing ............................................................................................................... ............................................... 15 The personal diabet es manager (PDM) ........................................................................................... ............................. 16 Install battery ............................................................................................................... .................................................. 16 Buttons ....................................................................................................................... .................................................... 18 LCD screen .................................................................................................................... ................................................. 19 2 HOME screen ................................................................................................................... .............................................. 19 Screen icons .................................................................................................................. ................................................. 20 Battery ....................................................................................................................... ............................................ 20 Time ............................................…

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This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. Member of the SGS Group (SGS SA) SGS IECC Limited Units 303-305, 3/F., 31 Lok Yip Road, On Lok Tsuen, Fanling, N.T., Hong Kong Telephone: +852 23052570 Fax: +852 27564480 FEDERAL COMMUNICATIONS COMMISSION CAB Registration number: 446297 No. VF59688 Verification of Conformity for FCC DoC Procedure It is herewith confirmed and found the following designated product Product Name: Insulin management system (Wireless USB stick) Model : MD-FM-007 ( Product Identification ) to comply with the technical requirements set up by ANSI C63.4 & CFR 47 FCC PART 15 regulations for the evaluation of electromagnetic compatibility with. Test Report Number(s): 59688 issued on: August 15, 2013 ( Identification of regulations / standards ) Applicant : Medtrum technologies Address : 7F, Building 8, No.200 Niudun Rd, Shanghai, China ( Applicant Identification ) TEST LABORATORY This is the test result, that was carried out based on the submitted sample(s) of the product in conformity with the specification of the respective standards. LOKE Sai Kit, Wilson Senior Manager August 15, 2013 This verification is related to the submitted sample(s) and in conjunction with the test data detailed in the above test report.

THIS MUST BE SIGNED BY THE APPLICANT/AGENT AND SHOULD BE PLACED ON APPROPRIATE LETTERHEAD Request for Confidentiality Date: 2013-8-8 _ Subject: Confidentiality Request for: _FCC ID:2AARUFM007________ Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term External Photos Short Term Permanent* 1 Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Parts List & Placement/BOM Short Term Permanent Tune-Up Procedure Short Term Permanent Schematics Short Term Test Setup Photos Short Term Permanent* User’s Manual *Note: ______(Insert Explanation as Necessary)______ _ Medtrum technologies ____ ______ has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of ___(specify number of days not to exceed 180 ) 2 ___ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications: The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Sincerely, By: Project Manager_ Sherry He____ (Signature/Title 3 ) (Print name) 1 - The asterisked items (*) require further justification before permanent confidentiality will be allowed. These also currently require review by the FCC under their Permit-But-Ask policy before the grant is issued and can delay completion of an application. Further justification should be added to the note above. One such example for a potted device would be: “The EUT is FULLY potted using a non-removable epoxy based material. Removal of potting material causes irreparable damage to internal circuitry. See photographs exhibits that outline the device before and after potting.” 2 - Please refer to http://acbcert.com/documents/misc-docs/Memo-Short-Term-Vs-Standard-Confidentiality.pdf for complete details. 3 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.

SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix A Page: 1 of 4 Page 1 of 4 MD-SY-007 (MD-FM-007) _External Photos Application No.: SHEM1307001427RF Applicant: MEDTRUM TECHNOLOGIES Inc. Address of Applicant: 7F, Building 8, No.200 Niudun Rd, Shanghai, China Equipment Under Test (EUT): Product Name: Insulin management system (Wireless USB stick) Brand Name: N/A Model No.: MD-SY-007 (MD-FM-007) SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix A Page: 2 of 4 Page 2 of 4 1 Contents Page 1 CONTENTS..........................................................................................................2 2 EXTERNAL PHOTOS........................................................................................3 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix A Page: 3 of 4 Page 3 of 4 2 External Photos SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix A Page: 4 of 4 Page 4 of 4 End

Wireless USB Stick MD-FM-007

SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix B Page: 1 of 4 Page 1 of 4 MD-SY-007 (MD-FM-007) _Internal Photos Application No.: SHEM1307001427RF Applicant: MEDTRUM TECHNOLOGIES Inc. Address of Applicant: 7F, Building 8, No.200 Niudun Rd, Shanghai, China Equipment Under Test (EUT): Product Name: Insulin management system (Wireless USB stick) Brand Name: N/A Model No.: MD-SY-007 (MD-FM-007) SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix B Page: 2 of 4 Page 2 of 4 1 Contents Page 1 CONTENTS ..............................................................................................2 2 INTERNAL PHOTOS ...............................................................................3 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix B Page: 3 of 4 Page 3 of 4 2 Internal Photos SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix B Page: 4 of 4 Page 4 of 4 End

Index Vaule Reference 1 USB CON103 2 1uF C20,C21 3 22uF C22 4 0.01uF C121 5 3.9pF C162,C163 6 220pF C164,C165 7 8.2pf C166 8 5.6pF C167 9 0.1uF C168,C171,C172,C173,C174,C175 10 27pF C169,C170 11 NC_3.9pF C176,C177 12 NC_5.6pF C178 14 LED LED3 15 27nH L130,L132,L134 16 22nH L131 17 510ohm R133 18 10K R185 19 56K R206 20 10ohm R207,R208 21 1.5K R209 23 0ohm R211,R212 24 RF-Transceiver U65 25 IC U75 26 48M Crystal Y10

SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. 588 West Jindu Road,Songjiang District,Shanghai,China Telephone: +86 (0) 21 6191 5666 Fax: +86 (0) 21 6191 5678 [email protected] Report No.: SHEM130700142701 Page 1 of 21 Tony Wu E&E Section Manager SGS-CSTC (Shanghai) Co., Ltd. The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. If the product in this report is used in any configuration other than that detailed in the report, the manufacturer must ensure the new system complies with all relevant standards. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government. All test results in this report can be traceable to National or International Standards. This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only 1 Cover Page FCC REPORT Application No. : SHEM1307001427RF Applicant: MEDTRUM TECHNOLOGIES Inc. FCC ID: 2AARUFM007 Equipment Under Test (EUT): NOTE: The following sample(s) submitted was/were identified on behalf of the client as Product Name: Insulin management system (Wireless USB stick) Brand Name: N/A Model: MD-SY-007 (MD-FM-007) Added Model: N/A Standards: FCC PART 15 Subpart C: 2012 Date of Receipt: July 30, 2013 Date of Test: August 07, 2013 Date of Issue: August 08, 2013 Test Result : PASS * *In the configuration tested, the EUT detailed in this report complied with the standards specified above. SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM130700142701 Page 2 of 21 2 Version Revision Record Version Chapter Date Modifier Remark 00 / August 08, 2013 / Original Authorized for issue by: Engineer Zenger Zhang Print Name Clerk Susie Liu Print Name Reviewer Keny Xu Print Name SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. Report No.: SHEM130700142701 Page: 3 of 21 “This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm . Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only.” 3 Test Summary Test Item Test Requirement Test method Result Antenna Requirement 47 CFR Part 15, Subpart C Section 15.203 ANSI C63.10(2009) PASS AC Power Line Conducted Emission 47 CFR Part 15, Subpart C Section 15.207 ANSI C63.10(2009) N/A Field Strength of the Fundamental Signal 47 CFR Part 15, Subpart C Section 15.231 (b) ANSI C63.10(2009) PASS Spurious Emissions 47 CFR Part 15, Subpart C Section 15.231 (b)/15.209 ANSI C63.10(2009) PASS 20dB Bandwidth 47 CFR Part 15, Subpart C Section 15.231 (c) ANSI C63.10(2009) PASS Dwell Time 47 CFR Part 15, Subpart C Section 15.231 (a) ANSI C63.10(2009) PASS Remark: This EUT is powered by battery only; therefore the AC Conducted Emission test is not applicable. SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. Report No.: SHEM130700142701 Page: 4 of 21 “This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm . Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reprodu…

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SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix C Page: 1 of 3 Page 1 of 3 MD-SY-007 (MD-FM-007) _Test Setup Photos Application No.: SHEM1307001427RF Applicant: MEDTRUM TECHNOLOGIES Inc. Address of Applicant: 7F, Building 8, No.200 Niudun Rd, Shanghai, China Equipment Under Test (EUT): Product Name: Insulin management system (Wireless USB stick) Brand Name: N/A Model No.: MD-SY-007 (MD-FM-007) SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix C Page: 2 of 3 Page 2 of 3 1 Contents Page 1 CONTENTS............................................................................................................... 2 2 EQUIPMENT UNDER TEST PICTURES ............................................................. 3 2.1 Radiated Spurious Emission ................................................................ 3 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1307001427RF －Appendix C Page: 3 of 3 Page 3 of 3 2 EQUIPMENT UNDER TEST PICTURES 2.1 Radiated Spurious Emission Below 1GHz Above 1GHz End