VN5-N3Contour Next Link 2.4 Wireless Blood Glucose Meter

Active Insulin 1.5 u Bolus Basal 5.2mmol/L BG 12: 0 0 PM ® 5.2 mmol L Before Meal Before Meal 12:00 PM l 10/1312:00 PM l 10/13 BolusBolus ReminderReminder NotesNotes ®® USER GUIDE Uses only CONTOUR ® NEXT blood glucose test strips from Bayer Wireless Blood Glucose Monitoring System DATE: CLIENT: DESCRIPTION: SCHAWK JOB#: SKU#: DIMENSIONS: PRINTER SPEC: RELEASE: V-1 LANGUAGE(S):ENGLISH INTERNAL: R-X 18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454 BAN#:81552940 Rev. 05/14 Contour Next Link 2.4 User Guide CA Alt#1 - 04/15/14 Copy Changes April 15, 2014 Bayer HealthCare Contour Next Link 2.4 User Guide CA English 913155 9755 Parent BAN# 81558914 7.5" (H) x 6.5" (W) 10000012465 REV FONTS: Helvetica, Helvetica Neue, Zapf Dingbats, Skinny Mini, Mini Micra, Myriad Pro COLORS: Cyan Magenta Yellow Black NOTE: THIS COLOR PROOF INDICATES COLOR BREAK ONLY AND MAY NOT ACCURATELY REFLECT ACTUAL PRODUCTION COLOR. Regional Master Template No: M-UG-0346-R0001 Clinical Trial / Global Master Template No: M-UG-0303-R0005 FC: 22.5mm BC: 14 mm Footer: 7mm 1/3rd of the Cross clear space has been applied. 7mm min. 81552940_CntrNextLINK2_4_UG_ENca_FpBp_v1.indd ofc181552940_CntrNextLINK2_4_UG_ENca_FpBp_v1.indd ofc14/15/14 11:45 AM4/15/14 11:45 AM iiiii ® INTENDED USE The CONTOUR ® NEXT LINK 2.4 wireless blood glucose monitoring system from Bayer (meter, test strips and control solution) is intended for self-testing by persons with diabetes to monitor glucose concentrations for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertip or palm. It is intended for in vitro diagnostic use only. The clinical utility of this device is that it may be used as an aid to monitor the effectiveness of a diabetes control program. The C ONTOUR NEXT LINK 2.4 wireless blood glucose monitoring system is intended to be used to transmit glucose values and send a remote bolus to compatible MiniMed 640G Insulin Pump and facilitate transfer of information to Medtronic CareLink ® Software through use of radio frequency communication. The CONTOUR NEXT LINK 2.4 wireless blood glucose monitoring system from Bayer is not intended for the diagnosis of or screening for diabetes mellitus and it is not intended for use on neonates. IMPORTANT SAFETY INFORMATION WARNINGS • Use a new lancet each time you test because it is no longer sterile after use. • Always dispose of test strips and lancets as medical waste or as advised by your health care professional. All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases. PRECAUTIONS • Read your CONTOUR ® NEXT LINK 2.4 user guide, the lancing device package insert, your MiniMed ® pump user guide and all instructional materials provided in your meter kit before testing. Please follow all instructions for use and care exactly as described to help avoid inaccurate results. • Examine product for missing, damaged, or broken parts. If the test strip bottle is open inside a new box of strips, do not use those strips. For replacement parts, contact Customer Service. Please see back cover for contact information. • The C ONTOUR ® NEXT LINK 2.4 meter from Bayer only works with CONTOUR ® NEXT test strips and C ONTOUR ® NEXT control solutions. • Always keep the C ONTOUR NEXT test strips in their original bottle. Tightly close the bottle immediately after removing a test strip. The bottle is designed to keep the test strips dry. Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, and dirt. Exposure to room humidity from leaving the bottle open or not storing the strips in their original bottle can damage your test strips. This could lead to inaccurate results. Do not use a test strip that appears damaged or has been used. • Check the expiry dates on your test strips and control solution. Do not use the test strips or control solution if the expiry date printed on the bottle label and carton has passed. This can cause inaccurate results. For the control solution, do not use if it has been 6 months since you first opened the bottle. After first opening the bottle, write the 6-month discard date on the control solution label. • If your control solution test result is out of range, contact Customer Service. Please see back cover for contact information. Do not use the meter for blood glucose testing until you resolve this issue. • The meter has been designed to give accurate results at temperatures between 5° to 45°C. If you are outside this range, you should not test. Whenever the meter is moved from one location to another, allow approximately 20 minutes for the meter to adjust to the temperature of the new location before performing a blood glucose test. • Do not perform a blood glucose test when the C ONTOUR NEXT LINK 2.4 meter is connected to a computer. • Use only approved cables or wall charger from the manufacturer or a 5V charger approved by a certified body such as UL, TUV or CSA. • The C ONTOUR ® NEXT LINK 2.4 meter from Bayer has been preset and locked to display results in mmol/L (millimoles of glucose per litre of blood).  Results in mmol/L will always have a decimal point;  Results in mg/dL will never have a decimal point. Example: . or 93  Check your display screen to be sure the results are shown the right way. If not, please see Customer Service contact information on the back cover of this user guide. • The C ONTOUR NEXT LINK 2.4 wireless blood glucose monitoring system from Bayer has a measuring range of 1.1 mmol/L to 33.3 mmol/L.  For results under 1.1 mmol/L or over 33.3 mmol/L; о If your blood sugar reading is under 1.1 mmol/L, the “Follow Medical Advice Immediately” screen will display and the meter will beep twice. Contact your health care professional. The C ONTOUR NEXT LINK 2.4 wireless blood glucose monitoring system is intended for single-patient use only and should not be shared. Serious Illness • Capillary (fingerstick or Alternative Site) blood gluc…

Text truncated - open the document above for the full version.

Bayer HealthCare LLC Diabetes Care Contour Next Link 2.4 Wireless Blood Glucose Monitoring System Photos External:

Bayer HealthCare LLC Diabetes Care Customer Service Information Label Location For Contour Next Link 2.4 Wireless Blood Glucose Monitoring System (FCC ID: VN5-N3) The label is located on the back side of the meter display screen. Meter Back Label Artwork

Bayer HealthCare LLC Diabetes Care Contour Next Link 2.4 Wireless Blood Glucose Monitoring System Photos Internal: Bayer HealthCare LLC Diabetes Care Contour Next Link 2.4 Wireless Blood Glucose Monitoring System Photos Internal:

RF Exposure Technical Brief Cover Sheet (per RSS-102 Issue 4, Annex C) Exemption from Routine Evaluation Limits v1 page 1 of 1 Declaration of RF Exposure Compliance for Exemption from Routine Evaluation Limits ATTESTATION: I attest that the radiocommunication apparatus meets the exemption from the routine evaluation limits in Section 2.5 of this standard; that the Technical Brief was prepared and the information contained therein is correct; that the device evaluation was performed or supervised by me; that applicable measurement methods and evaluation methodologies have been followed; and that the device meets the SAR and/or RF field strength limits of RSS-102. Signature: Date:9/12/14 NAME (Please print or type): Mary Sampson TITLE (Please print or type): Senior Project Engineer COMPANY (Please print or type): Intertek Testing Services NA Inc

09/16/2014 Report Number: 101227082ATL-002 Issued: Intertek 2.0 Test Summary 1.0 Introduction and Conclusion Test DateTest Full NameResultSection Overview of EUT (Low Power Transmitters) (FCC 15C - EUT Overview)4.0 07/25/2013Duty Cycle Determination (FCC 15A - 15.35(c))PASS5.0 07/26/2013Radiated emissions (E-field) for low power intentional radiators. (Radiated Emissions LPD)PASS6.0 07/29/2013Occupied Bandwidth (FCC Part 2.1049)PASS7.0 07/29/2013Additional provisions to the general radiated emission limitations. (FCC 15C - 15.215)PASS8.0 Revision History (Revision History)9.0 Conducted emissions on AC power lines (Conducted Emissions) was waived due to the device operates in battery mode only. NA The tests indicated in section 2.0 were performed on the product constructed as described in section 3.0. The remaining test sections are the verbatum text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. Page 2 of 32EMC Report for Bayer Healthcare on the US (6211) Canada (9755) AU (6213) 09/16/2014 Report Number: 101227082ATL-002 Issued: Intertek 3.0 Description of Equipment Under Test Equipment Under Test Description Manufacturer Model Number Co un try Co nto u r Ne xt ( Plu s) Lin k 2 .4 Wireless Blood Glucose Monitoring System Bayer HealthCare, LLC 6211 US Co nto u r Ne xt ( Plu s) Lin k 2 .4 Wireless Blood Glucose Monitoring System Bayer HealthCare, LLC 9755 Canada Co nto u r Ne xt ( Plu s) Lin k 2 .4 Wireless Blood Glucose Monitoring System Bayer HealthCare, LLC 6213 Australia EUT receive date: 07/21/13 EUT rece ive condition: Good Des cr ipti on of EUT pr o v ided by Cli ent: Bayer’s Contour Next (Plus) Li nk 2.4 Wireless Blood Glucose Monitoring System (Meter, test strips and control solution) is intended for self-testing by persons with diabetes to monitor glucose concentrations for the quantitative measurement of glucose in venous and whole blood and fresh capillary whole blood drawn from the fi ngertip or palm. The Contour Next (Plus) Link 2.4 Wireless Blood Glucose Monitoring System is intended to be used to measure BG and obtain a result i n mg/dL or mmol /L, transmit glucose values an d s end a re mo te bo lu s to Med tro n ic Mini Med d evic es (M iniMed 6 40 G I ns uli n Pump) and facilitate transfer of information to CareLink® Personal therapy manage ment software through use of radio frequency communication. BGM and Pump needs to go through association process to connect to each other before BG value or Bolus can be sent from the BGM to the Pump. In its simplie st form, the system consists of a Pump coordinator and BGM endnode. The coordinator is the center of a star wireless network that may contain multiple BGM end nodes. The BGM Bol us functi on allows se nding a manual or preset bol us from BGM to the Pump if the pump and BGM are connected. A manual or preset bol us can be sent from the test results screen or from the Main Menu. The Re mote Bolus feature can be turned on/turned off at the pump. To summarize, to se nd a bolus from t he BGM, the BGM must be connected to the pump and the Remote Bolus feature must be turned O N at the pump. Description of EUT exercising: For the transmit mode, the meter was set from 2420-2480MHz, whic h was monitored by a spectrum analyzer to determine consistent signal strength during the test, and placed in an idle mode for non-transmit tests. Page 3 of 32EMC Report for Bayer Healthcare on the US (6211) Canada (9755) AU (6213) 09/16/2014 Report Number: 101227082ATL-002 Issued: Intertek Overview of EUT (Low Power Transmitters) (FCC 15C - EUT Overview)4.0 Method: Complete the overview spreadsheet. Related Submittal(s) Grants: This report is for use with an application for certification of a low power transmitter. One transmitter is included in the application. Bay er Healt h Care LLC 430 S. Beiger Street M is h awaka, In diana 46544 Trade Name & Model No. Contour Next (Plus) Link 2.4 Wireless Blood Glucose Monitoring System FCC Identifier VN5-N3 Trade Name & Model No. Contour Next (Plus) Link 2.4 Wireless Blood Glucose Monitoring System IC Identifier 7347A-3 Freq uen cy Ran g e (M Hz) 2420-2480 A nten na Typ e (15.203) In ternal - PCB Bay er Healt h Care LLC 430 S. Beiger Street M is h awaka, In diana 46544 Additions, deviations and exclusions from standards None This report is for use with an application for certification of a low power transmitter. One transmitter is included in the application. Applicant Manufacturer name & address Related Submittals and Grants: Data: Page 4 of 32EMC Report for Bayer Healthcare on the US (6211) Canada (9755) AU (6213) 09/16/2014 Report Number: 101227082ATL-002 Issued: Intertek Duty Cycle Determination (FCC 15A - 15.35(c))5.0 Method: (c) Unless otherwise specified, e.g. §15.255(b), when the radiated emission limits are expressed in terms of the average value of the emission, and pulsed operation is employed, the measurement field strength shall be determined by averaging over one complete pulse train, including blanking intervals, as long as the pulse train does not exceed 0.1 seconds. As an alternative (provided the transmitter operates for longer than 0.1 seconds) or in cases where the pulse train exceeds 0.1 seconds, the measured field strength shall be determined from the average absolute voltage during a 0.1 second interval during which the field strength is at its maximum value. The exact method of calculating the average field strength shall be submitted with any application for certification or shall be retained in the meas…

Text truncated - open the document above for the full version.