NMTBG201SmartChip

Wireless SmartClip for CoaguChek® XS meter User Manual INTRODUCTION Thank you for selecting our Wireless SmartClip for your Roche® Coagulation Meter, which is a transmission Wireless SmartClip 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 2net TM Hub or some mobile devices through BLE technology. From now on, you can systematically monitor and manage your PT values via wireless technology. Mobile device with this logo is compatible with the Wireless SmartClip to achieve reliable transmission linkage. IMPORTANT Please thoroughly read this user manual for all the necessary information to operate your Wireless SmartClip. OVERVIEW 1. LED light 2. Battery compartment 3. ON / OFF switch 4. Clip 5. Non-slippery pads BATTERY INSTALLATION Battery is pre-installed in your BLE transmission Wireless SmartClip when you purchase. Please regularly check the battery and replace battery promptly as it may affect the transmission (refer to LED indicator table on page. X). To replace the battery: INSTALLATION • Align the coagulation meter with the Wireless SmartClip and insert the meter into the Wireless SmartClip with some pressure until it clips into place. UNINSTALLATION 1. Unscrew the battery compartment cover using a coin. 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. Return the compartment cover and screw it tightly. Status Normal Battery Low Battery Critical Battery Power on On in green for 1 second On in green for 1 second Flashes in red three times per minute. Start mode (pinging for the meter) OFF OFF Flashes in red three times per minute. Communicating with Meter/Hub Flashes in green once per second Flashes in green and red alternatively Flashes in red three times per minute. Transmission completed Blue is on for 5 seconds Flashes in blue and red alternatively Flashes in red three times per minute. Transmission fails / Lost Flashes in red Flashes in red very quickly Flashes in red three times per minute. • Hold the Wireless SmartClip and pull the meter from the left- hand side with some pressure. OPERATION After the Wireless SmartClip is installed onto the meter, you need to turn on the Wireless SmartClip to ensure the transmission works. Make sure you power up the coagulation meter in priority of turning on the Wireless SmartClip. The effective distance between a counterpart station, such as a hub, and the coagulation meter should be not far from each other more than 10 meters or 32.8 feet data from the Wireless SmartClip. Please wait until the connection has been re-established automatically. • Note: If you measured your prothrombin time (PT) without data transmission, the collected PT values will be automatically transmitted once a data connection will be established again. Turn off the Wireless SmartClip: • Slide the switch to OFF after having ensured a successful data transmission . The effective distance between a counterpart station, such TM Turn on the Wireless SmartClip: as a 2net hub, and the Wireless SmartClip should be not far from • Slide the switch to ON . LED indicator lights up briefly in green (given a normal battery status). • Run a prothrombin time (PT) measurement with the Roche CoaguChek XS meter, as described in the operating manual of the meter. • Once the PT measurement result is shown on the display of the CoaguChek XS meter, please do not turn off the meter, until the data transmissions will start automatically (within 60 seconds), which will be indicated by a green flashing LED. • Ensure that the blue LED indicates that data transmission was successful (steady or flashing according to the table below). • Once you saw the blue LED, your PT data has been transmitted successfully. • If there is no blue LED, please make sure that the receiving device (e.g. 2net TM hub) is turned on and able to receive the each other more than 10 meters. LED INDICATOR connection SPECIFICATIONS Dimension (L x W x H) 84.5 x 131.5 x 36.6 mm (3.3 x 5.2 x 1.5 inches) Power 1 x CR2032 3V lithium battery Weight 52.8 g (1.86 oz) Operating temperature 10 ̊ C to 40 ̊ C (50 ̊ 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 Wireless SmartClip in a wet towel, nor with other wet materials. Use a soft, slightly moistened cloth. • Do not place or wash the Wireless SmartClip under running water instead clean it with a wet cloth. • Do not store the Wireless SmartClip 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 displa…

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Ersteller: U. Rodemeier Revision: 03 Erstelldatum: 03.08.01 Datum: 16.01.08 Seite 1 von 1 IDT Technology Limited PHOENIX TESTLAB GmbH Product Certification Königswinkel 10 D 32825 Blomberg RE : LETTER OF AGENCY AUTHORIZATION To Whom It May Concern: We, the undersigned, hereby authorize Shenzhen Huatongwei International Inspection Co., Ltd , authorized person Hans Hu to act on our behalf in all matters relating to application for equipment authorization, including the signing of all documents relating to these matters. 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, 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. This agreement is valid for one year or until further notice. Sincerely, Signatory Connect name: Alex Chan Applicant / Company Stamp: IDT Technology Limited Date: Apr 29, 2014

Ersteller: D. Brandhorst Revision: 00 Erstelldatum: 02.01.2012 Datum: 00.00.0000 Seite 1 von 1 Long/Short-term Confidentiality Request PHOENIX TESTLAB GmbH Date: 12 May 2014 Product Certification Königswinkel 10 D 32825 Blomberg FCC ID:NMTBG201 To Whom it may concerns, Pursuant to sections 0.457(d) and 0.459 of CFR 47 and to avoid premature release of sensitive information prior to marketing or release of the product to the public, we hereby requests long-term confidential treatment of information accompanying this application as outlined below: Schematics Parts List Block Diagram Tune-Up Info Operational Description In addition we hereby request the following exhibits contained in this application to be temporarily (short-term confidentilality) withheld from the public disclosure for an initial period of days until: not applicable External Photos Test Setup Photos Internal Photos Users Manual The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to rule 0.457(d), disclosure of this application and all accompanying documentation will not be made before the date of the GRANT for this application. Thank you for your attention in this matter. Signatory Connect name: Alex Chan Applicant / Company Stamp: IDT Technology Limited Date: May 12, 2014

Report No : TRE14030187 Page 31 of 34 6. External and Internal Photos of the EUT

Label location

MODEL: BG201 Product name: smartclip MADE IN CHINA Input: 3V 10mA (CR2032) : YLLL IDT Technology Limited Block C, 9/F Kaiser Estate Phase 1, 41Man Yue Street, Hunghom, Kowloon, HongKong 39.5MM 24.3MM R=1MM COLOR: PRINT BLACK C+BLUE PMS 286C ON WHITE SIZE: 39.5(L)X24.3(W)MM W/R=1MM(+/-0.2MM) MATERIAL: 80GSM SYNTHETIC PAPER(BW0053) FINISH: WITH GLOSSY PP TRANSPARENT COATING 注意：所有内容要印在表面处理里面，以防止油墨脱落. 100% IDT TECHNOLOGY LTD. AW (PDD) AW (CU) TEXT (ENG) TEX (P MGR) TRANS MODEL: BG201 CU : Roche APPROVAL MKTR : Kathy IP/Ellen Xu WOL: 1309022 TITLE: Unit label/FDA label(REV.10) PREPARED BY: QJWU(XX/ART)JELL DATE: 07-May-2014 FILE : F/O: DATE DATE DATE DATE DATE DATE P/N: 300208073-00001-10 P/N: 300208073-00001-10 REV.1 1/1 YLLL (please see S/O remark) Month Lot(001 for Jan., 002 for Feb.,..., and 012 for Dec.) eg. MMM=009(Sep) YEAR OF PRODUCT eg. Y=3(2013) FDA LABEL FCC ID: NMTBG201 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.

Report No : TRE14030187 Page 32 of 34 Report No : TRE14030187 Page 33 of 34 Report No : TRE14030187 Page 34 of 34 .......................End of Report.........................

The test r It is not pe Report R FCC ID ... Applican Address .. Manufactu Address.. Test item Trade Ma Model/Typ List Mode Standard Date of re Date of te Date of is Result .... Compiled ( position + Supervise ( position+ Approved ( position + Testing L Address .. Shenzhen This publi Shenzhen the mater assume li placemen report merely ermitted to c Reference No .................... t’s name ..... .................... urer.............. .................... m description ark ................ pe reference el .................. d ................... eceipt of test esting............ sue............ .............. ...... by +printed nam ed by +printed nam by +printed nam Laboratory N .................... n Huatongw cation may b n Huatongwe rial. Shenzhe ability for da nt and contex y correspond opy extracts o. ................. .................... .................... .................... .................... .................... n ................. .................... e ................... .................... .................... sample...... .................. ..................... .................. me+signature me+signature me+signature Name .......... .................... wei Internatio be reproduce ei Internation en Huatongw mages resul xt. ds to the test of these te s TEST ... : TRE1 ... : NMT ... : IDT T .... : Bloc k Hom .....: IDT T ......: 29-3 3 XiXia ... : Sma .... : / .... : BG2 0 .... : / ... : FCC .....: Mar 2 ......: Mar 2 ......: May ......: PAS e) .. : File a e) .. : Proje e) .. : RF M ... : She n .... : Keji N onal Inspec ed in whole o nal Inspection wei Internatio lting from the sample. st result witho T RE 14030187 TBG201 Technology k C, 9/F Kais , Kowloon, H Technology L 3 Block, IDT ang, BaoAn, rtChip 01 CFR Title 4 26, 2014 27, 2014- Ap 5, 2014 S administrator ect Engineer Manager Ha nzhen Huato Nan No.12 R ction Co., Ltd or in part for n Co., Ltd is nal Inspectio e reader's int out the writte PORT y Limited ser Estate Ph Hong Kong. Limited Technolog y ShenZhen 47 Part 15 Su pr 30, 2014 rs Jerome Lu Yuchao Wa ns Hu ongwei Inter Road, Hi-tech d. All rights non-commer acknowledge on Co., Ltd ta terpretation o en permission T R/C...... hase 1, 41 M y Limited, Ch ubpart C Se uo ang rnational Ins h Park, Shen reserved. rcial purpose ed as copyrig akes no resp of the reprod n of the test l ....: 54147 Man Yue Stre enTian Indus ection 15.247 spection Co nzhen, China es as long as ght owner an ponsibility for uced materia laboratory. 7 eet, Hung strial Estate, 7 o., Ltd a s the nd source of and will not al due to its Report No : TRE14030187 Page 2 of 34 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 Peak Output Power 10 4.3. Power Spectral Density 12 4.4. 6dB bandwidth 14 4.5. Band Edge 16 4.6. Spurious Emission (conducted) 21 4.7. Spurious Emission (radiated) 25 5. TEST SETUP PHOTOS OF THE EUT 3 0 6. EXTERNAL AND INTERNAL PHOTOS OF THE EUT 31 Report No : TRE14030187 Page 3 of 34 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 NA 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: 1. The measurement uncertainty is not included in the test result. 2. NA: Not Apply, because the EUT is a battery type product. Report No : TRE14030187 Page 4 of 34 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: SmartChip Trade Mark: / Model/Type reference: BG201 List Model: / Power supply: DC 3.0V (CR2032 Size) 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: 0.5 dBi 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 : TRE14030187 Page 5 of 34 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. …

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Report No : TRE14030187 Page 30 of 34 5. Test Setup Photos of the EUT