2ABD4COCRFID Finger Sensor Assembly

AccuSom with RFID Finger Sensor Assembly User Manual • Do not use near, place or drop water or other liquid on unit. • Do not use an extension cord. • Operating temperature: 32-104 degrees Fahrenheit- The unit must not be used will charging. Description & Restrictions The AccuSom Home Sleep Test is a medical device used in the diagnostic evaluation of adults suspected of having sleep apnea. . AccuSom is a prescription device, and therefore Federal Law restricts this device to sale or use by a physician, or as prescribed by, a physician. FCC 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. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on to try to correct the interference by one or more of the following measures. -Increase the separation between the AccuSom and the receiver. - IMPORTANT! Changes or modifications not expressly approved by NovaSom, Inc. could void the users’s authority to operate the equipment. The AccuSom device-with RFID Finger Sensor Assembly is not intended for use by persons with pacemakers or persons with internal cardiac defibrillators (ICD). The RFID Bracelet will be secured to your wrist prior to testing by your physician’s office or designated clinic. The RFID Reader (black box) on the RFID finger sensor must be positioned over the RFID disc in the bracelet. Make sure the word “NovaSom” on the bracelet is under the RFID Reader (black box) on the Finger Sensor. If the bracelet will not stay in place, use the tape provided with the AccuSom. Put tape over the strap and bracelet on each side to secure If the voice prompt says “Check Finger Sensor” makes sure that the RFID bracelet is under the Finger Sensor RFID Reader (black box). Make sure that the Finger sensor is connected to the AccuSom. The RFID finger sensor may take up to 15 minutes to acquire the finger sensor signal as it needs to read the RFID disk in the bracelet. If the RFID bracelet is not positioned correctly under the RFID Reader on the finger sensor during testing the Finger Sensor will disconnect and data recording will stop. The Finger Sensor LED will flash yellow within 40 minutes. The device will discontinue recording unless the finger sensor signal is acquired. Use tape provided to hold the bracelet in place if necessary. Tape over the wrist strap and bracelet on either side of your arm to secure. AccuSom™ is a trademark of NovaSom, Inc. 2013 Form xx0000 Rev A

NovaSom' lnnovative 5leep Sotutions Attention: Application Examiner Re: Request for confidentiality Applicant: NovaSom, Inc. FCC ID:2ABD4coc To whom it may concern, P erm an ent C onft d enti ality Request is hereby submitted by NovaSom, Inc to withhold permanently from public review certain portions of the application for equipment certification for the referlnced FCC identifiers. This request for confidentiality is made pursuant to 4T CFR 0.4S7(d) and 0'459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential : o Schematics o Detailed Block diagrams o Detailed Operational/Functional Description o Parts list o Internal photos NOTE : Additional justification: (1) Device is not sold to end user. [2) Board is encased in medicalgrade material. (3J Non-consumer device inaccessible to general public and is only serviceable . by the manufacturer or designated technicians. Short-term Confidentiality Request is hereby submitted by NovaSom, Inc. to withhold from public review for a period of 45 days from the date of the Grant of Equipment Authorization and prior to marketing certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 4T CFR 0.4S7(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept confidential for a period of 45 days from the date of Authorization:- lSelect one or more of items below that are not selected in the list above, as appropriate] o External photos o User Manual t:.:.:;a.:.ri.;ii!t]t+.._ NovaSom, lnc.. 801 Cromwell Park Drive, Suite 108 . Clen Burnie, MD 21061 ollice 410.590.O443 t'oli-t'ree 877,753.3776 rux 410.590.4403 Rationale for request for confidentiality: NovaSom, Inc 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. Disclosure of the short-term confidential portions of this application during the period of importation and/or distribution would reveal key aspects of proprietary technology to competitors and diminish the value of our investment in research and development.] If you have questions or need further information, please contact the undersigned. Sincerely, Laurie Yates Sr. Director of IT and Product Development NovaSom,lnc. "" Xlw" NovaSom, lnc, . 801 Cromwell Park Drive, Suite 108 . Gten Burnie, MD 21061 oflice 410.590.0443 toblrce 877.753.3776 rax 410.590.4403

Letter of Agency I appoint Intertek Testing Services NA Inc. to act on our behalf in front of the Federal Communications Commission with respect to all matters relating to certification of equipment under the FCC rules until further notice. |fl4her certify that no party (as defined inL2002 of CFR 47,lgg5) to this application, including myself, is subject to denial of federal benefits, that inciudes FCi-benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of l9gg, 2l u.s.c.,g53A. Equipment: RFID Finger Senspr Assembly Dated this {day of December,2}l3 Signature Name Sr. Director of IT & Product Development Title NovaSom.Inc. Companv 415-613-8421 cell, Telephone Laurie Yates

Purchased Part Specification Revision 11.27.2013 External Photos Back side Side view Connector side External Photos Side View Finger Sensor side Top View External Photos RFID Tag Bracelet back side RFIG Tag Bracelet Front Side

RFID Finger Sensor Model: COC2013 Label Specification Purchased Part Specification Revision 11.27.2013 Label Specifications and photos 1.000 in. x 1.0000 Total Size (max) FCC ID: 2ABD4COC N ovaSom logo- two color blue/yellow Font 7 point See Image below: P lacement of label: Top cover of RFID Reader Black Enclosure Top View

EMC Report for NovaSom, Inc. on COC2013 File: 101310621MPK-008 Page 1 of 27 TEST REPORT Report Number: 101310621MPK-008 Project Number: G101310621 November 24, 2013 Testing performed on the RFID Finger Sensor Assembly Model Number: COC2013 FCC ID: 2ABD4COC to FCC Part 15 Subpart C (15.209) FCC Part 15 Subpart C (15.207) FCC Part 15, Subpart B Class: B for NovaSom, Inc. Test Performed by: Test Authorized by: Intertek 1365 Adams Court Menlo Park, CA 94025 USA NovaSom, Inc. 801 Cromwell Park Drive Glen Burnie, MD 21061 USA Prepared by: Date: November 24, 2013 Jainu Jogani Reviewed by: Date: November 24, 2013 Krishna K Vemuri This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to copy or distribute this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. This report must not be used to claim product endorsement by A2LA, NIST nor any other agency of the U.S. Government. EMC Report for NovaSom, Inc. on COC2013 File: 101310621MPK-008 Page 2 of 27 VERIFICATION OF COMPLIANCE Report No. 101310621MPK-008 Verification is hereby issued to the named APPLICANT and is VALID ONLY for the equipment identified hereon for use under the rules and regulations listed below. Equipment Under Test: RFID Finger Sensor Assembly Trade Name: NovaSom, Inc. Model No.: COC2013 Serial No.: AccuSom with RFID Finger Sensor Assembly and other sensors M/N: NS2010 Sl: 020712402 RFID Finger Sensor Assembly M/N: COC2013 Sl: MPK1309061148-012 Applicant: NovaSom, Inc. Contact: Laurie Yates Address: NovaSom, Inc. 801 Cromwell Park Drive Glen Burnie, MD 21061 Country USA Tel. number: 415-613-8421 email: [email protected] Applicable Regulation: FCC Part 15 Subpart C (15.209) FCC Part 15 Subpart C (15.207) FCC Part 15, Subpart B Equipment Class: Class B Date of Test: September 27 – November 08, 2013 We attest to the accuracy of this report: Jainu Jogani Project Engineer Krishna K Vemuri EMC Senior Staff Engineer EMC Report for NovaSom, Inc. on COC2013 File: 101310621MPK-008 Page 3 of 27 TABLE OF CONTENTS EXECUTIVE SUMMARY ........................................................................................................ 4 1.0 Job Description................................................................................................................ 5 1.1 ....... Client Information ........................................................................................................... 5 1.2 ....... Test Plan Reference ........................................................................................................ 5 1.3 ....... Equipment Under Test (EUT) ......................................................................................... 5 1.5 ....... System Block Diagram .................................................................................................... 6 1.6 ....... Justification ..................................................................................................................... 7 1.7 ....... Mode(s) of Operation ...................................................................................................... 7 1.8 ....... Modifications Required for Compliance......................................................................... 7 2.0 Test Environment for Emissions Testing ...................................................................... 8 2.1 ....... Test Facility .................................................................................................................... 8 2.2 ....... Test Equipment ............................................................................................................... 8 2.3 ....... Example Field Strength Calculation ............................................................................... 9 2.4 ....... Measurement Uncertainty ............................................................................................. 10 3.0 Emissions Test Results .................................................................................................. 11 3.1 ....... Transmitter Radiated Emissions ............................................................................... 11 3.1.1 .... Test Limits ........................................................................................................ 11 3.1.2 .... Test Procedure .................................................................................................. 12 3.1.3 .... Test Results ....................................................................................................... 13 3.2 ....... Radiated Emissions from Digital Parts ..................................................................... 16 3.2.1 .... Test Limits ........................................................................................................ 16 3.2.2 .... Test Procedure .................................................................................................. 17 3.2.3 .... Test Results ....................................................................................................... 18 3.2 ....... AC Mains Line-Conducted Disturbance .................................................................. 22 3.2.1 .... Test Limits .................................................................…

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Setup Photographs FCC ID: 2ABD4COC Radiated Emissions Radiated Emissions AC Mains Line-Conducted Emissions