U7I-BP3GU1-7BDigital Blood Pressure Monitor

Microlife AFIB BT – BP A6 BT Microlife AFIB BT – BP A6 BT Microlife AFIB BT – BP A6 BT (1) START/STOP Button (2) Display (3) Cuff Socket (4) Mains Adapter Socket (5) Battery Compartment (6) Cuff (7) Cuff Connector (8) AFIB/MAM Switch (9) Time Button (10) M-button (memory) (11) - «Backward» Button (12) + «Forward» Button (13) Lock Switch (14) USB Port Display (15) Date/Time (16) Systolic Value (17) Diastolic Value (18) Pulse Rate (19) Battery Display (20) Traffic Light Display (21) Stored Value (22) Pulse Indicator (23) Cuff Check Indicator (24) Atrial Fibrillation Indicator (AFIB) (25) AFIB/MAM Mode (26) Arm Movement Indicator (27) MAM Interval Time Read the instructions carefully before using this device Type BF applied part Microlife AFIB BT – BP A6 BT Dear Customer, Your new Microlife blood pressure monitor is a reliable medical device for taking measurements on the upper arm. It is simple to use, accurate and comes highly recommended for blood pressure monitoring in your home. This device was developed in collaboration with physicians and clinical tests carried out prove its measurement accuracy to be of a very high standard.* Microlife AFIB detection is the world’s leading digital blood pres- sure measurement technology for the detection of atrial fibrillation (AFIB) and hypertension. These are the two top risk factors of getting a stroke or heart disease in the future. It is important to detect AFIB and hypertension at an early stage, even though you may not experience any symptoms. Appropriate treatment will reduce your risk of suffering a stroke. For this reason, it is recommended that you visit your doctor when the device gives an AFIB signal during your blood pressure measurement. The AFIB algorithm of Microlife has been clinically investigated by several prominent clinical investigators and showed that the device detects patients with AFIB at a certainty of 97-100%. 1,2 Please read through these instructions carefully so that you under- stand all functions and safety information. We want you to be happy with your Microlife product. If you have any questions, prob -lems or want to order spare parts please contact Microlife- Customer Service. Your dealer or pharmacy will be able to give you the address of the Microlife dealer in your country. Alternatively, visit the internet at www.microlife.com where you will find a wealth of invaluable information on our products. Stay healthy – Microlife AG *This device uses the same measuring technology as the award winning «BP 3BTO-A» model tested according to the British Hypertension Society (BHS) protocol. 1. Stergiou GS, Karpettas N, Protogerou A, Nasothimiou EG, & Kyriakidis M. Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation. J Hum Hyperten 2009; 1-5. 2. Wiesel J, Fitzig L, Herschman Y, & Messineo FC Detection of Atrial Fibrillation Using a Modified Microlife Blood Pressure Monitor. Am J Hypertens 2009; 848-852. Microlife AFIB BT – BP A6 BT Table of Contents 1. Important Facts about Blood Pressure and Self-Measurement • How do I evaluate my blood pressure? 2. Important Facts about Atrial Fibrillation (AFIB) • What is Atrial Fibrillation (AFIB)? • How does AFIB impact my family or me? • Microlife AFIB detection provides a convenient way to screen for AFIB (only in AFIB/MAM mode) • Risk factors you can control 3. Using the Device for the First Time • Inserting the batteries • Setting the date and time • Selecting the correct cuff • Select the measuring mode: standard or AFIB/MAM mode • AFIB/MAM mode (highly recommended) 4. Taking a Blood Pressure Measurement using this Device • How not to store a reading 5. Appearance of the Atrial Fibrillation Indicator for early Detection (only in AFIB/MAM mode) 6. Traffic Light Indicator in the Display 7. PC-Link Functions • Installation and data transmission 8. BT-Link Function • Installation and data transmission 9. Data Memory • Viewing the stored values • Memory full • Clearing all values 10. Battery Indicator and Battery change • Low battery • Flat battery – replacement • Which batteries and which procedure? • Using rechargeable batteries 11. Using a Mains Adapter 12. Error Messages 13. Safety, Care, Accuracy Test and Disposal • Safety and protection • Device care • Cleaning the cuff • Accuracy test • Disposal 14. Guarantee 15. Technical Specifications Guarantee Card (see Back Cover) 1. Important Facts about Blood Pressure and Self- Measurement • Blood pressure is the pressure of the blood flowing in the arteries generated by the pumping of the heart. Two values, the systolic (upper) value and the diastolic (lower) value, are always measured. • The device indicates the pulse rate (the number of times the heart beats in a minute). • Permanently high blood pressure values can damage your health and must be treated by your doctor! • Always discuss your values with your doctor and tell him/her if you have noticed anything unusual or feel unsure. Never rely on single blood pressure readings. • There are several causes of excessively high blood pressure values. Your doctor will explain them in more detail and offer treatment where appropriate. Besides medication, weight loss and exercise can also lower your blood pressure. • Under no circumstances should you alter the dosages of any drugs prescribed by your doctor! • Depending on physical exertion and condition, blood pressure is subject to wide fluctuations as the day progresses. You should therefore take your measurements in the same quiet conditions and when you feel relaxed! Take at least two readings every time (in the morning and in the evening) and average the measurements. • It is quite normal for two measurements taken in quick succession to produce significantly different results. Therefore we recommend to use the MAM technology. • Deviations between measurements taken by your doctor or in the pharmacy and those taken at home are quite normal, as these situations are completely different. • Several measureme…

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DATE :Aug. 19, 2015 Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCCID: U7I-BP3GU1-7B Product Name: Digital Blood Pressure Monitor RequestforConfidentiality Pursuant to Sections 0.457 and 0.459 of the commissions rules, we hereby request that the following documents be held confidential: (List here the documents for which you are seeking confidentiality – for example ...)  Sch ematics  Block diagram Op eration description These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Dated this Agency agreement expiration date:Aug. 19, 2015 toAug. 18, 2016 By:Jimmy Deng SignaturePrinted Title:manager Onbehalf of :Microlife Corporation Telephone:886-2-87971288

Labelinformation: Label FCCID: U7I-BP3GU1-7B

RF Exposure evaluation report RF Exposure Compliance Requirement 1. Standard Requirement 15.247(b)(4) requirement: The conducted output power limit specified in paragraph (b) of this section is based on the use of antennas with directional gains that do not exceed 6dBi. Except as shown in paragraph (c) of this section. if transmitting antennas of directional gain greater than 6dBi are used. the conducted output power from the intentional radiator shall be reduced below the stated values in paragraphs (b)(1). (b)(2). and (b)(3) of this section. as appropriate. by the amount in dB that the directional gain of the antenna exceeds 6dBi. 2. Limits According to KDB447498 General RF Exposure Guidance v05 The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances
50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)]  [  f(GHz)]
3.0 for 1-g SAR and
7.5 for 10-g extremity SAR, where  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation  The result is rounded to one decimal place for comparison The test exclusions are applicable only when the minimum test separation distance is
50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. 3. EUT RF Exposure The Max Conducted Peak Output Power is6.006dBm (3.99mW) in low channel and the Max Conducted Average Output Power is less than 3.99mW. The best case gain of the antenna is 0dBi. 3.99 /5*  2.402=1.24
3.0 Conclusion: No SAR is required.

Report No. :EED32H000773Page 1 of 59 1COVER PAGE TEST REPORT Product:Digital Blood Pressure Monitor Trade mark: Model/Type reference :BP3GU1-7B(BP A6 BT) Serial Number:N/A Report Number:EED32H000773 FCC ID:U7I-BP3GU1-7B Date of Issue:Aug. 20, 2015 Test Standards:47 CFR Part 15 Subpart C (2014) Test result:PASS Prepared for: Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei 11492, Taiwan, R.O.C. Prepared by: Centre Testing International (Shenzhen) Corporation Building C, Scientific Innovation Park, Tiegang Reservior, Xixiang, Baoan District, Shenzhen, China TEL: +86-755-3368 3668 FAX: +86-755-3368 3385 Tested by:Reviewed by: Approved by:Date:Aug. 20, 2015 Sheek Luo Lab supervisor CheckNo.: 1996296977 Report No. :EED32H000773Page 2 of 59 2Version Version No.DateDescription 00 Aug. 20, 2015 Original Report No. :EED32H000773Page 3 of 59 3 Test Summary Test ItemTest RequirementTest methodResult Antenna Requirement 47 CFR Part 15 Subpart C Section 15.203/15.247 (c) ANSI C63.10-2013 PASS AC Power Line Conducted Emission 47 CFR Part 15 Subpart C Section 15.207 ANSI C63.10-2013 PASS Conducted Peak Output Power 47 CFR Part 15 Subpart C Section 15.247 (b)(1) ANSI C63.10-2013 PASS 20dB Occupied Bandwidth 47 CFR Part 15 Subpart C Section 15.247 (a)(1) ANSI C63.10-2013 PASS Carrier Frequencies Separation 47 CFR Part 15 Subpart C Section 15.247 (a)(1) ANSI C63.10-2013 PASS Hopping Channel Number 47 CFR Part 15 Subpart C Section 15.247 (b) ANSI C63.10-2013 PASS Dwell Time 47 CFR Part 15 Subpart C Section 15.247 (a)(1) ANSI C63.10-2013 PASS Pseudorandom Frequency Hopping Sequence 47 CFR Part 15 Subpart C Section 15.247(b)(4)&TCB Exclusion List (7 July 2002) ANSI C63.10-2013 PASS RF Conducted Spurious Emissions 47 CFR Part 15 Subpart C Section 15.247(d) ANSI C63.10-2013 PASS Radiated Spurious emissions 47 CFR Part 15 Subpart C Section 15.205/15.209 ANSI C63.10-2013 PASS Test according to ANSI C63.4-2014 & ANSI C63.10-2013. Report No. :EED32H000773Page 4 of 59 4 Content 1 COVER PAGE...............................................................................................................................................................1 2 VERSION....................................................................................................................................................................... 2 3 TEST SUMMARY......................................................................................................................................................... 3 4CONTENT......................................................................................................................................................................4 5 TEST REQUIREMENT.................................................................................................................................................5 5.1T EST SETUP........................................................................................................................................................... 5 5.1.1 For Conducted test setup.............................................................................................................................. 5 5.1.2 For Radiated Emissions test setup.............................................................................................................. 5 5.1.3 For Conducted Emissions test setup...........................................................................................................6 5.2T ESTENVIRONMENT..............................................................................................................................................6 5.3T ESTCONDITION....................................................................................................................................................6 6 GENERAL INFORMATION.........................................................................................................................................7 6.1C LIENTINFORMATION............................................................................................................................................7 6.2G ENERALDESCRIPTION OFEUT......................................................................................................................... 7 6.3P RODUCTSPECIFICATION SUBJECTIVE TO THIS STANDARD...............................................................................7 6.4D ESCRIPTION OFSUPPORTUNITS....................................................................................................................... 8 6.5T ESTLOCATION.....................................................................................................................................................8 6.6T ESTFACILITY....................................................................................................................................................... 8 6.7D EVIATION FROMSTANDARDS..............................................................................................................................9 6.8A BNORMALITIES FROMSTANDARDCONDITIONS.................................................................................................9 6.9O THERINFORMATIONREQUESTED BY THECUSTOMER..................................................................................... 9 6.10 M EASUREMENTUNCERTAINTY(95%CONFIDENCE LEVELS,K=2)...................................................................10 7 EQUIPMENT LIST......................................................................................................................................................11 8 RADIO TECHNICAL REQUIREMENTS SPECIFICATION.................................................................................13 Appendix A) 20dB Occupied Bandwidth................................................................................................................. 14 Appendix B) Carrier Frequency Separation...........................................…

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