Q4O-1-50Ambio Scale

Ambio Remote Health Monitoring System Clinician User Guide Ambio Remote Health Monitoring System Customer Service www.ambiohealth.com/contact [email protected] 203-612-5600 Manufacturer Ambio Health Soundview Plaza Suite 700R 1266 E. Main Street Stamford, CT 06902 © 2014 Ambio Health, Soundview Plaza Suite 700R, 1266 E. Main Street, Stamford, CT 06902 Firmware © Ambio Health 2011-2014 Ambio Care Portal © Ambio Health 2011-2014 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. FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. This Clinician User Guide is for Clinicians and their Organizations. A User Guide for Patients and non-clinician Caregivers is also available which excludes sections 3, 7 and 8. Contents 1. General Precautions ........................................................................ 4 2. Terms Used in This Guide ................................................................. 5 3. Set up Organization ......................................................................... 6 A. Set up Company Information ............................................... 7 B. Set-up Master Administrator ................................................ 7 C. Log In .................................................................................... 7 D. Manage Company Information............................................. 7 E. Set up Locations ................................................................... 8 F. Set up Clinicians .................................................................... 8 G. Enroll Patients ...................................................................... 8 H. Set up considerations for using an ‘intensive’ care model ... 9 4. Manage Patient Settings ................................................................. 10 A. Manage Patient Information .............................................. 10 B. Add / Manage Caregivers ................................................... 12 C. Add / Manage Devices ........................................................ 12 D. Set Reading Alert Levels ..................................................... 13 E. Set Reading Target Levels ................................................... 14 F. Set Reading Schedule and Reminders ................................ 14 G. Add / Manage Medication List and Reminders................... 15 H. Add / Manage Goals for Readings and Targets ................... 15 I. Add / Manage Patient Surveys ........................................... 16 5. Install Devices in the Patient’s Home ............................................. 18 A. What you need ................................................................... 18 B. Install the Gateway ............................................................. 18 C. Install Wireless Connectors ................................................ 19 D. Install the Scale................................................................... 19 6. Take and Send Health Meter Readings ........................................... 20 A. Blood Pressure Readings .................................................... 20 B. Blood Glucose Readings ..................................................... 21 C. Scale Readings .................................................................... 21 7. Clinician Dashboard ........................................................................ 22 A. Overall Task List – Number of Tasks View .......................... 22 B. Overall Task List – Calendar View ....................................... 22 C. Detailed Task List View ....................................................... 22 D. Compete Tasks / Enter Encounter Records ........................ 23 E. Schedule a New Task .......................................................... 24 F. Print / Email Patient Records .............................................. 24 2 1-000-0060C Rev H - Clinician G. Add New Patient / Manage Patient Info............................. 24 H. Manage Patient Referrals ................................................... 24 8. Supervisor Dashboard .................................................................... 25 A. Clinician List ........................................................................ 25 B. Manage Patient Referrals ................................................... 26 9. Administrator Dashboard ............................................................... 26 A. Locations List ...................................................................... 26 B. Company Settings ............................................................... 27 C. Manage Patient Referrals ................................................... 28 10. View Patient Health Data ............................................................. 28 A. Set-up your Account ........................................................... 28 B. Log In .................................................................................. 28 C. Patient Dashboard .............................................................. 28 D. View Health Readings ......................................................... 30 E. Blood Glucose Readings and Graphs .................................. 30 F. Blood Pressure Readings and Graphs ................................. 35 G. Scale Readings and Graphs ................................................. 37 H. Email Graphs and Logs ....................................................... 38 1. Print Reading Graphs and Logs ........................................... 38 I. View Survey Results ........................................................... 39 J. Exercise Log .........................................…

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Authority to Act as Agent April 17, 2014 American Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 To Whom It May Concern: ______ SGS Consumer Testing Services ______ is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b) ,to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Expiration Date: _April 17, 2015___ By:__________________________Kevin R. Jones (Signature)(Print name) Title:CEO On behalf of: Arrayent Health LLC, d/b/a Ambio Health (Company Name) Telephone:973-568-0323 Kevin R. Jones Arrayent Health LLC Ambio Health Soundview Plaza, Suite 700R 1266 E Main Street Stamford, CT 06902 1 ______________________________________________________________________________________________________________________________________________________________________________________________________________________________________ (Signatututututututututututututututututututututututututututututututututututututututututututututututure)

Kevin R. Jones Ambio Health Soundview Plaza, Suite 700R 1266 E Main Street Stamford, CT 06902 973-568-0323 Attention: Application Examiner Re: Request for confidentiality Applicant: Arrayent Health LLC d/b/a Ambio Health FCC ID: Q4O-1- 50 To whom it may concern, Permanent Confidentiality Request is hereby submitted by Arrayent Health LLC to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential: • Schematics • Detailed Block diagrams • Detailed Operational/Functional Description • Parts list Rationale for request for confidentiality: Arrayent Health LLC has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. The fee for confidentiality has been submitted along with the fee for certification. If you have questions or need further information, please contact the undersigned. Sincerely, CEO Arrayent Health LLC d/b/a Ambio Health

FCC ID: Q4O-1-50 1. External Bottom 2. External Top

FCC ID: Q40-1-50 1. FCC ID Label Contents The Ambio Scale will be marketed as the following part number: 1-050-01 Ambio Scale The label contents are: Ambio Scale 1-050-01 6V 4 x 1.5V ‘AAA’ alkaline batteries Ambio Health 1266 E Main St. Stamford, CT 06902 Designed in USA, Assembled in China FCC ID: Q4O-1-50 [Barcode] SN: SCA00000001 PW: XXXX 2. FCC ID Label Location Label position is bottom of scale

Test Report Number: 3482330 Rev: 0 Arrayent Health LLC / Ambio Scale Page: 1 of 22 Remarks: This report details the results of the testing carried out on one sample, the results contained in this test report do not relate to other samples of the same product. The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. This report may only be reproduced and distributed in full. 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. Any mention of SGS International Electrical Approvals or Testing done by SGS International Electrical Approvals in connection with distribution or use of the product described in this report must be approved by SGS international Electrical Approvals in writing. EMC Test Report Project Number: 3482330 Report Number: 3482330EMC01 Revision Level: 0 Client: Arrayent Health LLC, d/b/a Ambio Health Equipment Under Test: Ambio Scale Model Number: 1-050-01 FCC ID: Q4O-1-50 Applicable Standards: § 15.249 Operation within the bands 902–928 MHz, 2400–2483.5 MHz, 5725–5875 MHZ, and 24.0–24.25 GHz. ANSI C63.10: 2009 Report issued on: 05 May 2014 Test Result: Compliant Tested by: Jeremy O. Pickens, Senior EMC Engineer Reviewed by: David Schramm, EMC Manager Test Report Number: 3482330 Rev: 0 Arrayent Health LLC / Ambio Scale Page: 2 of 22 SGS North America Inc. Consumer Testing Services 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.us.sgs.com/cts Member of the SGS Group (SGS SA 1 SUMMARY OF TEST RESULTS ..................................................................................................................................... 3 1.1 MODIFICATIONS REQUIRED FOR COMPLIANCE .............................................................................................................. 3 2 GENERAL INFORMATION ............................................................................................................................................. 3 2.1 CLIENT INFORMATION ................................................................................................................................................... 3 2.2 TEST LABORATORY ....................................................................................................................................................... 3 2.3 GENERAL INFORMATION OF EUT .................................................................................................................................. 3 2.4 OPERATING MODES AND CONDITIONS .......................................................................................................................... 4 2.5 EUT CONNECTION BLOCK DIAGRAM ............................................................................................................................ 4 2.6 SYSTEM CONFIGURATIONS ............................................................................................................................................ 4 3 FIELD STRENGTH OF FUNDAMENTAL ..................................................................................................................... 5 3.1 TEST RESULT ................................................................................................................................................................. 5 3.2 TEST METHOD ............................................................................................................................................................... 5 3.3 TEST SITE ...................................................................................................................................................................... 6 3.4 TEST EQUIPMENT .......................................................................................................................................................... 6 3.5 TEST SETUP PHOTOGRAPHS ........................................................................................................................................... 6 3.6 TEST DATA .................................................................................................................................................................... 6 4 FIELD STRENGTH OF SPURIOUS RADIATION ........................................................................................................ 7 4.1 TEST RESULT ................................................................................................................................................................. 7 4.2 TEST METHOD ............................................................................................................................................................... 7 4.3 TEST SITE ...................................................................................................................................................................... 8 4.4 TEST EQUIPMENT .......................................................................................................................................................... 8 4.5 TEST SETUP PHOTOGRAPHS ........................................................................................................................................... 8 4.6 TEST DATA .................................................................................................................................................................... 9 5 OCCUPIED BANDWIDTH ............................................................................................................................................. 17 5.1 TEST RESULT ............................................................................................................................................................... 17 5.2 TEST METHOD ............................................................................…

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