Q6ZHEM6321TBlood Pressure Monitor

SAFETY INFORMATION INTENDED USE The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. To assure the correct use of the product, basic safety measures should always be followed including the warnings and cautions listed in this instruction manual. GENERAL USAGE Contact your physician for specific information about your blood pressure. Self-diagnosis and treatment using readings may be dangerous. Follow the instructions of your physician or licensed healthcare provider. DO NOT adjust medication based on readings from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat High Blood Pressure. The monitor is not intended to be a diagnostic device. Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases. Note that PATIENT motion, trembling, shivering may affect the reading. Do not use the device on the injured wrist or the wrist under medical treatment. Do not apply the wrist cuff on the arm while being on an intravenous drip or blood transfusion. Contains small parts that may cause a choking hazard if swallowed by infants. Consult your physician before using the device on the wrist with an arterio-venous (A-V) shunt. Do not use the device with other medical electrical (ME) equipment simultaneously. Do not use the device in the area the high frequency (HF) surgical equipment, magnetic resonance imaging (MRI), or computerized tomography (CT) scanner exists, or in the oxygen rich environment. BATTERY USAGE Keep the batteries out of the reach of young children. DATA TRANSMISSION Do not use this product on aircraft or in hospitals. Please remove the battery from the unit. This product emits radio frequencies (RF) in the 2.4 GHz band, use of this product in locations where RF is restricted is not recommended. The use of RF in this product is licensed for use by the FCC/IC, for further information on any potential restrictions refer to documentation on Bluetooth ® usage by the FCC/IC. GENERAL USAGE Consult your physician before using the device for any of the following conditions: • If you have had a mastectomy. • If you have a condition that may compromise circulation, you may get an inaccurate reading with this device. • People with severe blood flow problems or blood disorders as cuff inflation can cause bruising. Do not take measurements more than necessary. It may cause bruising due to blood flow interference. Read all of the information in the instruction manual and any other literature in the box before operating the unit. Do not use this device on infants or persons who cannot express their intentions. Operate the device only as intended. Do not use the device for any other purpose. Do not use a mobile phone or other devices that emit electromagnetic fields near the device except when in use for wireless communications. This may result in incorrect operation of the device. Do not use the device in a moving vehicle (car, airplane). Use only Omron authorized parts and accessories. Parts and accessories not approved for use with the device may damage the unit. Although this device is waterproof (IP22), please be careful about the operating environment. BATTERY USAGE Use only 1.5V Alkaline batteries with this device. Do not use other types of batteries. This may damage the device. Do not replace the batteries while the data is transferred. SAFETY SYMBOLS USED IN THIS INSTRUCTION MANUAL WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. BEFORE TAKING A MEASUREMENT To ensure a reliable reading, follow these recommendations: 1. Avoid eating, drinking alcohol, smoking, exercising, and bathing for 30 minutes before taking a measurement. Rest for at least 5 minutes before taking the measurement. 2. Stress raises blood pressure. Avoid taking measurements during stressful times. 3. The cuff can be applied to your left or right wrist. 4. Measurements should be taken in a quiet place. 5. Position the unit at heart level throughout the measurement. 6. Remain still and do not talk during the measurement. 7. Keep a record of your blood pressure and pulse readings for your physician. A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency. INTRODUCTION Thank you for purchasing the OMRON BP654 Wrist Blood Pressure Monitor. Fill in for future reference. DATE PURCHASED: __________________ SERIAL NUMBER: ____________________ • Staple your purchase receipt here • Register your product on-line at www.register-omron.com SAVE THESE INSTRUCTIONS INSTRUCTION MANUAL Model BP654 3200764-8A Wrist Blood Pressure Monitor UNIT DISPLAY DISPLAY SYMBOLS HEARTBEAT SYMBOL ( ) The Heartbeat symbol flashes on the display at every heartbeat during the measurement. AVERAGE READING SYMBOL ( ) The Average Reading Symbol is displayed when you press and hold the button for more than 2 seconds. The most recent average reading appears on the display screen. IRREGULAR HEARTBEAT SYMBOL ( ) When the monitor detects an irregular rhythm two or more times during the measurement, the Irregular Heartbeat Symbol will appear on the display with the readings. An irregular heartbeat r…

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Label Design and Location 51.5 18.0 4 ‐ R1 Unit[mm] ・ It is difficult to put a printed label on the cuff, because it is bent when it is wrapped one's arm for measuring blood pressure . Therefore the following notice is described in the user manual. 「 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. 」 ・ It is extremely difficult for users to remove the cuff by using a screwdriver. The main reasons are as follow; ‐ The screw is located between the cuff and the chassis on the back side of main screen, so usually users don't see it. ‐ In order to remove the screw, user needs to keep to push the flipped cuff. ‐ Used cannot know that this screw fixes the cuff, so it is considered as dismantling BP monitor itself to remove this screw. ‐ The cuff is fixed not only with the screw but also with tubes and stoppers, so it is difficult to remove. 1/1

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UL Japan, Inc. Ise EMC Lab 4383-326 Asama-cho, Ise-shi, Mie 516-0021 Japan T:: +81.596.24.8999 / F:: +81.596.24.8124 / W:: ul.com/jp March 5, 2015 UL Japan, Inc. 4383-326 Asama-cho, Ise-shi, Mie 516-0021 Japan FCC ID: Q6ZHEM6321T To whom it may concern, We, UL Japan, Inc, hereby declare that Blood Pressure Monitor, model: HEM-6320T-Z (BP654) (FCC ID: Q6ZHEM6321T) of Omron Healthcare Co., Ltd. is exempt from RF exposure SAR evaluation as its output power meets the exclusion limits stated in KDB 447498D01(V05). KDB 447498D01(V05) has the following exclusion for portable devices: The 1g and 10g 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. This device has f = 2.48 GHz and distance = 5 mm (minimum separation distance: 5mm was used in the calculation) and the maximum average output power was 1 mW So for this device: 1 mW[maximum average output power]/5 mm[minimum separation distance]*√2.48 = 0.3 *This is less than 3.0, so no SAR is required. Even taking into account the tolerance, this device can be satisfied with the limits. Thank you for your attention to this matter. Takayuki Shimada Engineer of Ise EMC Lab. Consumer Technology Division UL Japan, Inc.

Test report No. : 10699546H-A-R1 Page : 2 of 27 Issued date : March 5, 2015 Revised date : March 16, 2015 FCC ID : Q6ZHEM6321T UL Japan, Inc. Ise EMC Lab. 4383-326 Asama-cho, Ise-shi, Mie-ken 516-0021 JAPAN Telephone : +81 596 24 8999 Facsimile : +81 596 24 8124 REVISION HISTORY Original Test Report No.: 10699546H-A Revision Test report No. Date Page revised Contents - (Original) 10699546H-A March 5, 2015 - - 1 10699546H-A-R1 March 16, 2015 P. 4 Addition of note about model number. Test report No. : 10699546H-A-R1 Page : 3 of 27 Issued date : March 5, 2015 Revised date : March 16, 2015 FCC ID : Q6ZHEM6321T UL Japan, Inc. Ise EMC Lab. 4383-326 Asama-cho, Ise-shi, Mie-ken 516-0021 JAPAN Telephone : +81 596 24 8999 Facsimile : +81 596 24 8124 CONTENTS PAGE SECTION 1: Customer information ......................................................................................................... 4 SECTION 2: Equipment under test (E.U.T.) ........................................................................................... 4 SECTION 3: Test specification, procedures & results ............................................................................ 5 SECTION 4: Operation of E.U.T. during testing .................................................................................... 8 SECTION 5: Radiated Spurious Emission .............................................................................................. 9 SECTION 6: Antenna Terminal Conducted Tests ................................................................................ 10 APPENDIX 1: Data of EMI test .............................................................................................................. 11 6dB Bandwidth ................................................................................................................................. 11 Maximum Peak Output Power .......................................................................................................... 13 Average Output Power ...................................................................................................................... 14 Radiated Spurious Emission ............................................................................................................. 15 Conducted Spurious Emission .......................................................................................................... 19 Power Density ................................................................................................................................... 22 99%Occupied Bandwidth ................................................................................................................. 24 APPENDIX 2: Test instruments ............................................................................................................. 25 APPENDIX 3: Photographs of test setup ............................................................................................... 26 Radiated Spurious Emission ............................................................................................................. 26 Worst Case Position .......................................................................................................................... 27 Test report No. : 10699546H-A-R1 Page : 4 of 27 Issued date : March 5, 2015 Revised date : March 16, 2015 FCC ID : Q6ZHEM6321T UL Japan, Inc. Ise EMC Lab. 4383-326 Asama-cho, Ise-shi, Mie-ken 516-0021 JAPAN Telephone : +81 596 24 8999 Facsimile : +81 596 24 8124 SECTION 1: Customer information Company Name : Omron Healthcare Co., Ltd. Address : 53 Kunotsubo, Terado-cho, Muko, Kyoto 617-0002 Japan Telephone Number : +81-75-925-2012 Facsimile Number : +81-75-925-2013 Contact Person : Hirokazu Furukawa SECTION 2: Equipment under test (E.U.T.) 2.1 Identification of E.U.T. Type of Equipment : Blood Pressure Monitor Model No. : HEM-6320T-Z (BP654) Serial No. : Refer to Section 4, Clause 4.2 Rating : DC 2.1-3.6V Receipt Date of Sample : February 7, 2015 (for Radiated Spurious Emission) February 26, 2015 (for Antenna Terminal Conducted Tests) Country of Mass-production : Vietnam Condition of EUT : Production prototype (Not for Sale: This sample is equivalent to mass-produced items.) Modification of EUT : No Modification by the test lab 2.2 Product Description General Specification Clock frequency(ies) in the system : 32.768kHz, 26MHz, 16MHz The EUT has two model numbers: HEM-6320T-Z and BP654. HEM-6320T-Z is for internal use. Also, BP654 is for user. Variant model: HEM-6321T-Z For HEM-6321T-Z, following functions are added from to the base model (EUT). - User exchange switch to Circuit board. (A raw circuit board is the same.) - Backlight on display. (Displays of each model are different. HEM-6321T-Z uses a transmissive-type display.) Radio Specification Bluetooth (Low Energy) Radio Type : Transceiver Frequency of Operation : 2402-2480MHz Modulation : GFSK Bandwidth & Channel Spacing : 1MHz & 2MHz Power Supply (radio part input) : DC 3.4-3.6V Antenna type : Chip Antenna Antenna Gain : 2.72dBi Test report No. : 10699546H-A-R1 Page : 5 of 27 Issued date : March 5, 2015 Revised date : March 16, 2015 FCC ID : Q6ZHEM6321T UL Japan, Inc. Ise EMC Lab. 4383-326 Asama-cho, Ise-shi, Mie-ken 516-0021 JAPAN Telephone : +81 596 24 8999 Facsimile : +81 596 24 8124 SECTION 3: Test specification, procedures & results 3.1 Test Specification Test Specification : FCC Part 15 Subpart C: 2015, final revised on January 21, 2015 Title : FCC 47CFR Part15 Radio Frequency Device Subpart C Intentional Radiators Section 15.207 Conducted limits Section 15.247 Operation within the bands 902-928MHz, 2400-2483.5MHz, and 5725-5850MHz 3.2 Procedures and results Item Test Procedure Specification Worst margin Results Remarks Conducted Emission FCC: ANSI C63.4:2009 7. AC powerline Conducted Emission measurements FCC: Section 15.207 N/A *1) N/A - IC: RSS-Gen 8.8 IC: RSS-Gen 8.8 6dB Bandwidth FCC: "Guidance for Performing Complianc…

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Test report No. : 10699546H-A-R1 Page : 26 of 27 Issued date : March 5, 2015 Revised date : March 16, 2015 FCC ID : Q6ZHEM6321T UL Japan, Inc. Ise EMC Lab. 4383-326 Asama-cho, Ise-shi, Mie-ken 516-0021 JAPAN Telephone : +81 596 24 8999 Facsimile : +81 596 24 8124 APPENDIX 3: Photographs of test setup Radiated Spurious Emission Photo 1 Photo 2 Test report No. : 10699546H-A-R1 Page : 27 of 27 Issued date : March 5, 2015 Revised date : March 16, 2015 FCC ID : Q6ZHEM6321T UL Japan, Inc. Ise EMC Lab. 4383-326 Asama-cho, Ise-shi, Mie-ken 516-0021 JAPAN Telephone : +81 596 24 8999 Facsimile : +81 596 24 8124 Worst Case Position (Horizontal: X-axis/ Vertical:Z-axis) X-axis Y-axis Z-axis End of Report