NMTBG100Smart Sleeve

Smart Sleeve for Roche Accu-Chek Aviva/ Performa Blood Glucose Meter User Manual IntRodUCtIon Thank you for selecting our Smart Sleeve for your Roche ® Accu-Chek Aviva/ Performa Blood Glucose Meter, which is a transmission Smart Sleeve accessory that can help you expand the meter from Infrared (IR) to Bluetooth Low Energy (BLE) transmission. This means the testing values can be transferred to a counterpart station, such as hub or some mobile devices through BLE technology. From now on, you can systematically monitor and manage your blood glucose values via wireless technology. Mobile device with this logo is compatible with the Smart Sleeve to achieve reliable transmission linkage. IMPoRtAnt Please thoroughly read this user manual for all the necessary information to operate your Smart Sleeve. oveRvIew 1. LED light 3 1 2 2. Battery compartment 3. Start button BAtteRy InStAllAtIon Battery is pre-installed in your Smart Sleeve when you purchase. Please regularly check the battery and replace a new battery promptly as it may affect the transmission. to replace the battery: 1. Open the battery compartment cover. 2. Remove the old battery and insert a new CR2032, 3V lithium battery. Make sure to place the battery in the compartment following the polarity +/-. 3. Put on the compartment cover. InStAllAtIon • Align and then insert the blood glucose meter into the Smart Sleeve until it fits into place. UnInStAllAtIon • Hold the Smart Sleeve and pull the meter out from the top with some pressure. oPeRAtIon After the Smart Sleeve is installed onto the meter, you need to turn on the Smart Sleeve to ensure the transmission works. Make sure you also turn on the blood glucose meter in its data transferring mode. note Please refer to the blood glucose meter’s user manual for the data tramission operation. note The Start button of the sleeve is placed & designed to be triggered while you operate the data transmisson mode of blood glucose meter. note The operation range between a counterpart station, such as a hub, and the coagulation meter should not be far from each other more than 10 meters or 32.8 feet. turn on the Smart Sleeve: • Turn on the data transmission mode of the blood glucose meter. • Press and Hold the Start button for two seconds. Red LED indicator turns on. • The data transmission will start automatically (within 90 seconds), which will be indicated by a red flashing LED. • When it is connected to the mobile application that you can collect: 1) the first data, 2) the latest data or 3) all the data. note The mobile application with the Smart Sleeve can only retrive the data record from the blood glucose meter. If you need to erase the record that inside the blood glucose meter, you have to follow its own procedures. turn off the Smart Sleeve: • The Smart Sleeve automatically turns off in 90s. • After each compete data transmission. note The operation range between a counterpart station, such as a mobile, and the Smart Sleeve should be not far from each other more than 10 meters. led IndICAtoR StatusLighting Start & ConnectingFlash every 3s Transmitting dataFlash every 0.25s Low batteryFlash every 1s Total time out90s SPeCIfICAtIonS Dimension (L x W x H) 45.2 x 104.23 x 29.75 mm (1.8x 4.1 x 1.2 inches) Power1 x CR2032 3V lithium battery Weight26g Operating temperature5 ̊C to 40 ̊C (41 ̊F to 104 ̊F) Storage temperature-25 ̊C to 70 ̊C (-13 ̊F to 158 ̊F) CARe InStRUCtIonS To ensure you use your product correctly and safely, read these warnings and the entire user manual before using the product: • Do not wrap the Smart Sleeve in a wet towel or with other wet materials. Use a soft, slightly moistened cloth. • Do not place or wash the Smart Sleeve under running water instead clean it with a wet cloth. • Do not store the Smart Sleeve in a hot (about 50°C) and humid (about 90%) environment. • Do not subject the product to excessive force, shock, dust, temperature changes, or humidity. Never expose the product to direct sunlight for extended periods. Such treatment may result in malfunction. Do not tamper with the internal components. Doing so will terminate the product warranty and may cause damage. The main unit contains no user-serviceable parts. • Take precautions when handling the battery. • Remove the battery whenever you are planning to store the product for a long period of time. • When replacing the battery, use a new battery as specified in this user manual. • The product is a precision instrument. Never attempt to take this device apart. Contact the retailer or our customer service department if the product requires servicing (depends on service concept). • Do not touch the exposed electronic circuitry, as there is a danger of electric shock. • Check all major functions following the User Manual if the device has not been used for a long time. • When disposing of this product, ensure that this is done according to the local guidelines. • Due to printing limitations, the displays shown in this manual may differ from the actual display. • The contents of this manual may not be reproduced without the permission of the manufacturer. note The technical specifications for this product and the contents of the user manual are subject to change without notice. CleAnInG tHe Sleeve It is important to follow the procedures below to clean and disinfect the sleeve. Failure to follow these procedures may cause malfunction of the sleeve. Cleaning/disinfecting the exterior Use only the following items for cleaning/disinfecting the Smart Sleeve for a contact time of >1 minute: • 70% isopropyl alcohol • 10% Sodium hypochlorite solution (1 part bleach to 9 parts deionized water, made fresh every 24 hours) note Do not use any other disinfectants/cleaning solutions on the Smart Sleeve. 1. Clean/Disinfect the Exterior With the Smart Sleeve powered off, wipe the Smart Sleeve’s exterior clean. • Do not let liquid accumulate near any opening. Make sure that no liquid enters the Smart Sleeve. 2. Dry the Exterior W…

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IDT Technology Limited 022311 – 6 Request for Confidentiality Date: 2014-07-04 Subject: Confidentiality Request for: FCC ID: NMTBG100 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* 2 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)______ IDT Technology Limited 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) 3 ___ 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, Alex Chan By: (Signature4) (Print name) 2 - 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.” 3 - Please refer to http://acbcert.com/documents/misc-docs/Memo-Short-Term-Vs-Standard-Confidentiality.pdf for complete details. 4 - 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.

IDT Technology Limited 022311 – 6 Authority to Act as Agent Date: 2014-07-04 American Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 To Whom It May Concern: Shenzhen Huatongwei International Inspection Co., Ltd / Hans Hu 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: _____2015-07-04_____ By: Alex Chan (Signature 1 ) (Print name) Title: Director of management dept On behalf of: IDT Technology Limited (Company Name) Telephone: 86-755-29701188 1 - 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.

Differences Declaration To whom concern, We company IDT Technology Limited hereby declares: The product model(s) BG100 SD is identical in the same PCB layout, interior structure and electrical circuits with the model BG100 which tested in Shenzhen Huatongwei International Inspection Co., Ltd, the only differences are the model name for commercial purpose. Sincerely yours, Name:Alex Chan Position: Director of management dept CompanyAdress: Block C, 9/F Kaiser Estate Phase 1, 41 Man Yue Street, Hung Hom, Kowloon, Hong Kong. Te l / F a x : 86-755-29701188/ 86-755-29709021 E-Mail: [email protected]

Report 6. Ext No : TRE14 ternal an 405020201 nd Intern nal Phot Extern tos of th al photos he EUT of the EU UT Pag ge 29 of 31

MODEL: BG100 LOT: YLLL Product name: Smart sleeve Input: 3V 8mA (CR2032) UC120171YYWWXXXXXX Made in China IDT Technology Limited Block C, 9/F Kaiser Estate Phase 1, 41Man Yue Street, Hunghom, Kowloon, HongKong FCC ID: NMTBG100 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 operantion. BG100 FDA LABEL

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Report No : TRE14405020201 Interna al photos of the EU T Pag ge 30 of 31 Report No : TRE1 4405020201 ................. ......End of R Report.......... ............... Pag ge 31 of 31

Report R FCC ID. .. Applican Address .. Manufactu Address.. Test item Trade Ma Model/Typ Listed Mo Standard Date of re Date of te Date of is Result .... Compiled ( position + Supervise ( position+ Approved ( position + Testing L Address .. Shenzhen This publi Huatongw Shenzhen for damag context. Reference No .................... t’s name ..... .................... urer.............. .................... m description ark ................ pe reference odel(s) .......... d ................... eceipt of test esting............ sue............ .............. ...... by +printed nam ed by +printed nam by +printed nam Laboratory N .................... n Huatongw cation may b wei Internatio n Huatongwe ges resulting o. ................. .................... .................... .................... .................... .................... n ................. .................... e ................... .................... .................... sample...... .................. ..................... .................. me+signature me+signature me+signature Name .......... .................... wei Internatio be reproduce onal Inspectio ei Internation from the rea TES ... : TRE1 ... : NMT ... : IDT T .... : Bloc k Kowl .....: IDT T ......: 29-33 Estat ... : Sma .... : / .... : BG1 0 .... : BG10 ... : FCC .....: May ......: May ......: Jun 1 ......: PASS e) .. : File a e) .. : Proj e e) .. : RF M ... : She n .... : Keji N onal Inspec ed in whole o on Co., Ltd is nal Inspection ader's interpr ST RE 1405020201 TBG100 Technology k C, 9/F Kais loon, Hong K Technology L 3 Block, IDT  te, XiXiang, rt Sleeve 00 00SD CFR Title 4 29, 2014 30, 2014- J u 12, 2014 S administrator ect Engineer Manager Han nzhen Huato Nan No.12 R ction Co., Ltd or in part for s acknowled n Co., Ltd tak retation of th EPOR y Limited ser Estate Ph Kong. Limited Technolog y  BaoAn, Sh 47 Part 15 Su un 11, 2014 rs May Hu Lion Cai ns Hu ongwei Inter Road, Hi-tech d. All rights non-commer ged as copy kes no respo e reproduce RT R/C......... hase 1, 41 M  yLimited,C enZhen ubpart C Se rnational Ins h Park, Shen reserved. rcial purpose right owner a onsibility for a d material du ....:22910 Man Yue Stre  ChenTian Ind ection 15.247 spection Co nzhen, China es as long as and source o and will not a ue to its plac eet, Hung Ho  dustrial 7 o., Ltd a s the Shenzh of the materia assume liabil cement and m, hen al. lity Report No : TRE1405020201 Page 2 of 31 Contents 1. TEST STANDARDS AND TEST DESCRIPTION 3 1.1. Test Standards 3 1.2. Test Description 3 2. SUMMARY 4 2.1. Client Information 4 2.2. Product Description 4 2.3. EUT operation mode 5 2.4. EUT configuration 5 2.5. Modifications 5 3. TEST ENVIRONMENT 6 3.1. Address of the test laboratory 6 3.2. Test Facility 6 3.3. Environmental conditions 7 3.4. Statement of the measurement uncertainty 7 3.5. Equipments Used during the Test 8 4. TEST CONDITIONS AND RESULTS 9 4.1. Antenna requirement 9 4.2. Conducted Emission (AC Main) 10 4.3. Conducted Peak Output Power 11 4.4. Power Spectral Density 13 4.5. 6dB bandwidth 15 4.6. Band Edge 17 4.7. Spurious Emission (conducted) 21 4.8. Spurious Emission (radiated) 23 5. TEST SETUP PHOTOS OF THE EUT 2 8 6. EXTERNAL AND INTERNAL PHOTOS OF THE EUT 2 9 Report No : TRE1405020201 Page 3 of 31 1. TEST STANDARDS AND TEST DESCRIPTION 1.1. Test Standards The tests were performed according to following standards: FCC Rules Part 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation within the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz. ANSI C63.10: American National Standard for Testing Unlicensed Wireless Devices KDB558074 D01 V03: Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS) Operating Under §15.247 1.2. Test Description Test Item Section in CFR 47 Result Antenna requirement 15.203/15.247 (c) Pass Line Conducted Emission (AC Main) 15.207 Not Application Conducted Peak Output Power 15.247 (b)(3) Pass Power Spectral Density 15.247 (e) Pass 6dB Bandwidth 15.247 (a)(2) Pass Band Edge 15.247(d) Pass Spurious Emission 15.205/15.209 Pass Remark: The measurement uncertainty is not included in the test result. Report No : TRE1405020201 Page 4 of 31 2. SUMMARY 2.1. Client Information Applicant: IDT Technology Limited Address: Block C, 9/F Kaiser Estate Phase 1, 41 Man Yue Street, Hung Hom, Kowloon, Hong Kong. Manufacturer: IDT Technology Limited Address: 29-33 Block,  IDT Technology Limited, ChenTian Industrial Estate,  XiXiang, BaoAn, ShenZhen 2.2. Product Description Name of EUT Smart Sleeve Trade Mark: / Model No.: BG100 Listed Model(s): BG100SD Power supply: DC 3.0V From internal battery Adapter information: / Bluetooth Version: Supported BT4.0 Modulation: GFSK Operation frequency: 2402MHz~2480MHz Channel number: 40 Channel separation: 2MHz Antenna type: Internal Antenna Antenna gain: 0dBi Operation Frequency List: Channel Frequency (MHz) 1 2402 2 2404 ...... 19 2438 20 2440 21 2442 ...... 39 2478 40 2480 Note: In section 15.31(m), regards to the operating frequency range over 10 MHz, the Lowest frequency, the middle frequency, and the highest frequency of channel were selected to perform the test, please see the above gray bottom. Report No : TRE1405020201 Page 5 of 31 2.3. EUT operation mode The EUT has been tested under typical operating condition. The Applicant provides software to control the EUT for staying in continous transmitting and receiving mode for testing. 2.4. EUT configuration The following peripheral devices and interface cables were connected during the measurement: ● - supplied by the manufacturer ○ - supplied by the lab ○ Power Cable Length (m) : / Shield : / Detachable : / ○ Multimeter Manufacturer : / Model No. : / 2.5. Modifications No modifications were implemented to meet testing criteria. Report No : TRE1405020201 Page 6 of 31 3. TEST ENVIRONMENT 3.1. Address of the test laboratory Shenzhen Huatongwei International Inspection Co., Ltd. Keji Nan…

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Report 5. Tes No : TRE1 4 st Setup 405020201 p Photo os of the Radiated Radiate e EUT d Emission (B d Emission ( Below 30MH (Above 1GHz Hz) z) Pag ge 28 of 31