ZRYGMM0001Blood Glucose Meter

IDEAL LIFE Gluco-Manager TM Blood Glucose Management System Model GMM00010001 Products may vary from images shown *NOTE: The IDEAL LIFE Gluco-Manager™ is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm,the calf and the thigh. It is intended for use by adults with diabetes mellitus in a non-clinical environment such as in the home, as an aid to monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of, or screening for, diabetes mellitus and not in- tended for use on neonates. The alternative site testing can be used only during steady state blood glucose conditions. The system is intended for information purposes only, for expert advice make sure to consult a healthcare professional. Any instructions for change in treatment and health related information or advice should only be made directly with a healthcare professional. Version 7.0 Jun 2013 INSTRUCTION MANUAL Read before use May be used with IDEAL LIFE Pod™ (sold separately) for use with IDEAL LIFE Health Management System™ 2IDEAL LIFE Gluco-Manager™ Table of Contents Table of Contents......................................2 Introduction.................................................3 Preface..........................................................3 Contraindications......................................3 Precautions..................................................4 Important Information..............................4 About Alternative Site Testing (AST)....6 Package Contents......................................7 Additional Items ........................................8 IDEAL LIFE Pod™Location/ Interference................................................ 9 Before You Start Your IDEAL LIFE Gluco-Manager™....................................10 Your IDEAL LIFE Pod™..........................11 Test Strip Description ............................12 Important Test Strip Information..........12 Powering Up Your IDEAL LIFE Gluco-Manager............................................13 First Time Power Up and Activation When Using a Pod..................................14 About Control Solution........................15 Important Control Solution Test Information...............................................15 How to do a Control Solution Test.....16 Functions...................................................18 Table of Contents Taking Your Blood Glucose Reading.....................................................19 Getting a drop of blood ......................19 When obtaining blood from sites other than the fingertip.........................19 Taking a reading......................................20 Looking at Previously Taken Readings...................................................21 Looking at Messages..............................22 Looking at Graphics...............................23 Comparing Meter and Laboratory Results......................................................24 Care and Maintenance..........................25 Cleaning and Desinfecting....................26 A List of the Signs of Potential Deterioration..........................................27 Specifications...........................................28 Limitations of Use..................................29 Problem Solving Guide..........................30 Error Message.........................................31 Summary of Operation.........................32 FCC Statement ......................................33 Customer Information..........................34 Service Requirements............................35 3 Instruction Manual Introduction Preface Thank you for purchasing the IDEAL LIFE Gluco-Manager™, or GMM 0001 and IDEAL LIFE Pod™, or ILP 0001. This completely automatic system measures your blood glucose, captures subjective information and manages information automatically so that you can better manage your blood glucose with your care provider. Your measurement reading is clearly displayed on a large screen on the IDEAL LIFE Gluco- Manager™ after each measurement, and later stored for a more detailed analysis in the form of tables for easy viewing and graphs for easy interpretation. Your new IDEAL LIFE Gluco-Manager™ provides you with accurate, whole blood test results for blood glucose. The system is compact with convenient operation so it is simple to use. Intended Use IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the fingertip and alternative sites for self-testing by persons with diabetes in the home, or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use). The IDEAL LIFE Gluco-Manager™ is not intended for the diagnosis of, or screening for, diabetes mellitus and not intended for use on neonates. The alternative site testing (the palm, forearm, upper arm, calf and thigh) using this system can be used only during steady-state blood glucose conditions. You do not need to calibrate your meter, making it easier for the user to monitor blood glucose at home. The IDEAL LIFE Gluco-Manager™ can wirelessly communicate to a communication gateway or an access point. CAUTION: Before using any product to test your blood glucose, read all instructions thoroughly and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional. For proper interpretation of blood glucose measurements, make sure to consult a physician. Contraindications **Warning: This system is designed for use outside the human body. It is not recommended for use on infants and is not intended for and should not be used to try and measure the blood glucose of infants as it may not be accurate and/or relied upon. Do NOT use the device for purposes other than measuring blood glucose. This unit does no…

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Request for Confidentiality Date: _2013-6-15_______ Subject: Confidentiality Request for: ______FCC ID: ZRYGMM0001, IC:9775A-GMM0001 _____ 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)______ _____ANDON HEALTH Co.,Ltd______ 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: ____ ____ ______Ming Cong__________________ (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.: SHEM1305000785ME －Appendix B Page: 1 of 6 Page 1 of 6 A50 PC Internal Photos Application No.: SHEM1305000785ME Applicant: Andon Health Co., Ltd. Address of Applicant: No. 3 JinPing Street, YaAn Road, Nankai District, Tianjin. 300190, China Equipment Under Test (EUT): Product Name: Blood Glucose Meter Brand Name: IDEAL LIFE Model No.: GMM0001 FCC ID: ZRYGMM0001 IC: 9775A-GMM0001 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1305000785ME －Appendix B Page: 2 of 6 Page 2 of 6 1 Contents Page 1 CONTENTS..........................................................................................................2 2 INTERNAL PHOTOS.........................................................................................3 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1305000785ME －Appendix B Page: 3 of 6 Page 3 of 6 2 Internal Photos SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1305000785ME －Appendix B Page: 4 of 6 Page 4 of 6 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1305000785ME －Appendix B Page: 5 of 6 Page 5 of 6 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1305000785ME －Appendix B Page: 6 of 6 Page 6 of 6 E EE En nn nd dd d

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.: SHEM130500078505 Page 1 of 76 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 FCC Part 15C TEST REPORT Application No. : SHEM1305000785ME Applicant: Andon Health Co., Ltd. FCC ID: ZRYGMM0001 IC: 9775A-GMM0001 Equipment Under Test (EUT): NOTE: The following sample(s) submitted was/were identified on behalf of the client as Product Name: Blood Glucose Meter Brand Name: IDEAL LIFE Model: GMM0001 Standards: FCC PART 15 SUBPART C, Section 15.247:2012 RSS-210 Issue 8 (December 2010) RSS-Gen Issue 3 (December 2010) Date of Receipt: May 08, 2013 Date of Test: May 31, 2013 to June 04, 2013 Date of Issue: June 18, 2013 Test Result: PASS * * In the configuration tested, the EUT (Equipment under test) complied with the standards specified above. SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. Report No.: SHEM130500078505 Page: 2 of 76 2 Version Revision Record Version Chapter Date Modifier Remark 00 / June 04, 2013 / Original Authorized for issue by: Zenger Zhang Engineer Print Name Susie Liu Clerk Print Name Keny Xu Reviewer Print Name SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. Report No.: SHEM130500078505 Page: 3 of 76 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 thesample(s) tested and such sample(s) are retained for 90 days only 3 Test Summary Test Item FCC Test Requirement IC Test Requirement Test method Result Antenna Requirement FCC Part 15, Subpart C Section 15.203/15.247 (c) RSS-Gen 7.1.2 --- PASS AC Power Line Conducted Emission FCC Part 15, Subpart C Section 15.207 RSS-Gen Section 7.2.4 ANSI C63.10 (2009) Section 6.2 N/A 20dB Occupied Bandwidth FCC Part 15, Subpart C Section 15.247 (a)(1) RSS 210 A 8.1(b) ANSI C63.10 (2009) Section 6.9.1 PASS Conducted Peak Output Power FCC Part 15, Subpart C Section 15.247 (b)(1) RSS 210 A 8.4(2) ANSI C63.10 (2009) Section 6.10.1 PASS Carrier Frequencies Separation FCC Part 15, Subpart C Section 15.247 (a)(1) RSS 210 A 8.1(b) ANSI C63.10 (2009) Section 7.7.2 PASS Hopping Channel Number FCC Part 15, Subpart C Section 15.247 (b) RSS 210 A 8.1(d) ANSI C63.10 (2009) Section 7.7.3 PASS Dwell Time FCC Part 15, Subpart C Section 15.247 (a)(1) RSS 210 A 8.1(d) ANSI C63.10 (2009) Section 7.7.4 PASS RF Conducted Spurious Emissions FCC Part 15, Subpart C Section 15.247(d) RSS 210 A 8.5 ANSI C63.10 (2009) Section 7.7.10 PASS Radiated Spurious emissions FCC Part 15, Subpart C Section 15.209 and Section 15.205 RSS-Gen section 4.9 ANSI C63.10 (2009) Section 6.12 PASS Radiated Band-edge FCC Part 15, Subpart C Section 15.205 RSS-Gen section 4.9 ANSI C63.10 (2009) Section 6.5 PASS 99% Occupied Bandwidth --- RSS-Gen section 4.6.1 RSS-Gen section 4.6.1 Test Remark: the device is power supplied by battery, so the Conducted Emission is not application. SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. Report No.: SHEM130500078505 Page: 4 of 76 This document is issued by the C…

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SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1305000785ME －Appendix C Page: 1 of 3 Page 1 of 3 GMM0001 Test Setup Photos Application No.: SHEM1305000785ME Applicant: Andon Health Co., Ltd. Address of Applicant: No. 3 JinPing Street, YaAn Road, Nankai District, Tianjin. 300190, China Equipment Under Test (EUT): Product Name: Blood Glucose Meter Brand Name: IDEAL LIFE Model No.: GMM0001 FCC ID: ZRYGMM0001 IC: 9775A-GMM0001 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1305000785ME －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 Emission Test Setup ..........................................................................3 SGS-CSTC Standards Technical Services (Shanghai)Co., Ltd. Report No.: SHEM1305000785ME －Appendix C Page: 3 of 3 Page 3 of 3 2 EQUIPMENT UNDER TEST PICTURES 2.1 Radiated Emission Test Setup 30MHz to 1GHz Above 1GHz End