Q6ZMHEM7145T2Blood Pressure Monitor

Introduction Important Safety Information 1. Know Your Monitor 2. Preparation 3. Using Your Monitor without a Telehealth Service Receiver 4. Using Your Monitor with a Telehealth Service Receiver 5. Using Memory Function 6. Other Settings 7. Error Messages and Troubleshooting 8. Maintenance 9. Optional Accessories 10. Specifications 11. FCC/ISED Statement 12. Limited Warranty 13. Guidance and Manufacturer’s Declaration Thank you for purchasing the OMRON BP9300T Blood Pressure Monitor. This monitor can be used by multiple users. This blood pressure monitor uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your brachial artery and converts the movements into a digital reading. Safety Instructions This instruction manual provides you with important information about the OMRON BP9300T Blood Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of these instructions. If you do not understand these instructions or have any questions, contact your Telehealth service provider or contact OMRON at 1-800-634-4350 before attempting to use this monitor. For specific information about your own blood pressure, consult with your physician. Intended Use This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and indicates this via a symbol with readings. Environments of Use: Home Patient Population: Adult Receiving and Inspection Remove this monitor and other components from the packaging and inspect for damage. If this monitor or any other components is damaged, DO NOT USE and contact your Telehealth service provider or contact OMRON at 1-800-634-4350. Symbols Glossary For symbol information, visit: OmronHealthcare.com/symbols-glossary Contraindications • This monitor is contraindicated for use in ambulatory environments. • This monitor is contraindicated for use on aircraft. Read the Important Safety Information in this instruction manual before using this monitor. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about your own blood pressure, CONSULT WITH YOUR PHYSICIAN. Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. • DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves. • 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. • DO NOT use this monitor on an injured arm or an arm under medical treatment. • DO NOT apply the arm cuff on your arm while on an intravenous drip or blood transfusion. • DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in incorrect operation of the monitor and/or cause an inaccurate reading. • DO NOT use this monitor in oxygen rich environments or near flammable gas. • Consult with your physician before using this monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease. NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the measurement reading. • NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician. • To help avoid strangulation, keep the air tube and AC adapter cable away from infants, toddlers and children. • This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers and children. Blood Pressure Monitor Model BP9300T Instruction Manual 3293795-5A Table of Contents Introduction Important Safety Information Data Transmission • This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth ® feature in this monitor, remove batteries and/or unplug the AC adapter when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC/ISED. AC Adapter (optional accessory) Handling and Usage • DO NOT use the AC adapter if this monitor or the AC adapter cable is damaged. If this monitor or the cable is damaged, turn off the power and unplug the AC adapter immediately. • Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug. • NEVER plug in or unplug the AC adapter from the electric outlet with wet hands. • DO NOT disassemble or attempt to repair the AC adapter. Battery Handling and Usage • Keep batteries out of the reach of infants, toddlers and children. Caution Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient, or cause damage to the equipment or other property. • Stop using this monitor and consult with your physician if you experience skin irritation or discomfort. • Consult with your physician before using this monitor on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow which could result in injury. • Consult with your physician before using this monitor if you have had a mastectomy. • Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising. • DO NOT take measurements more often than necessary because bruising, due to blood flow interference, may occur. • ONLY inflate the arm cuff when it is applied on your upper arm. • Remove the arm cuff if i…

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

Introduction Important Safety Information 1. Know Your Monitor 2. Preparation 3. Using Your Monitor without a Telehealth Service Receiver 4. Using Your Monitor with a Telehealth Service Receiver 5. Using Memory Function 6. Other Settings 7. Error Messages and Troubleshooting 8. Maintenance 9. Optional Accessories 10. Specifications 11. FCC/ISED Statement 12. Limited Warranty 13. Guidance and Manufacturer’s Declaration Thank you for purchasing the OMRON BP9310T Blood Pressure Monitor. This monitor can be used by multiple users. This blood pressure monitor uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your brachial artery and converts the movements into a digital reading. Safety Instructions This instruction manual provides you with important information about the OMRON BP9310T Blood Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of these instructions. If you do not understand these instructions or have any questions, contact your Telehealth service provider or contact OMRON at 1-800-634-4350 before attempting to use this monitor. For specific information about your own blood pressure, consult with your physician. Intended Use This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and indicates this via a symbol with readings. Environments of Use: Home Patient Population: Adult Receiving and Inspection Remove this monitor and other components from the packaging and inspect for damage. If this monitor or any other components is damaged, DO NOT USE and contact your Telehealth service provider or contact OMRON at 1-800-634-4350. Symbols Glossary For symbol information, visit: OmronHealthcare.com/symbols-glossary Contraindications • This monitor is contraindicated for use in ambulatory environments. • This monitor is contraindicated for use on aircraft. Read the Important Safety Information in this instruction manual before using this monitor. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about your own blood pressure, CONSULT WITH YOUR PHYSICIAN. Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. • DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves. • 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. • DO NOT use this monitor on an injured arm or an arm under medical treatment. • DO NOT apply the arm cuff on your arm while on an intravenous drip or blood transfusion. • DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in incorrect operation of the monitor and/or cause an inaccurate reading. • DO NOT use this monitor in oxygen rich environments or near flammable gas. • Consult with your physician before using this monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease. NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the measurement reading. • NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician. • To help avoid strangulation, keep the air tube and AC adapter cable away from infants, toddlers and children. • This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers and children. Blood Pressure Monitor Model BP9310T Instruction Manual 3293798-0A Table of Contents Introduction Important Safety Information Data Transmission • This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth ® feature in this monitor, remove batteries and/or unplug the AC adapter when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC/ISED. AC Adapter (optional accessory) Handling and Usage • DO NOT use the AC adapter if this monitor or the AC adapter cable is damaged. If this monitor or the cable is damaged, turn off the power and unplug the AC adapter immediately. • Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug. • NEVER plug in or unplug the AC adapter from the electric outlet with wet hands. • DO NOT disassemble or attempt to repair the AC adapter. Battery Handling and Usage • Keep batteries out of the reach of infants, toddlers and children. Caution Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient, or cause damage to the equipment or other property. • Stop using this monitor and consult with your physician if you experience skin irritation or discomfort. • Consult with your physician before using this monitor on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow which could result in injury. • Consult with your physician before using this monitor if you have had a mastectomy. • Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising. • DO NOT take measurements more often than necessary because bruising, due to blood flow interference, may occur. • ONLY inflate the arm cuff when it is applied on your upper arm. • Remove the arm cuff if i…

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

External Photos BP9300T and BP9310T Front side Back side Left side Right side Top Bottom

Condential B *Due to the size of product, the statement required by FCC 15.19(a) will be printed on users manual. IC: XXXXX-XXXXXXXX will be replaced by IC:10623A-HEM7145T2. FCC ID: XXX-XXXXXXX will be replaced by FCC ID: Q6ZMHEM7145T2. Condential B IC: XXXXX-XXXXXXXX will be replaced by IC:10623A-HEM7145T2. FCC ID: XXX-XXXXXXX will be replaced by FCC ID: Q6ZMHEM7145T2. **Due to the size of product, the statement require by FCC 15.19(a) will be printed on users manual.

Internal Photos BP9300T and BP9310T Antenna BLE-IC

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 January 24, 2022 FCC ID: Q6ZMHEM7145T2 To whom it may concern, We, UL Japan, Inc, hereby declare that Blood Pressure Monitor, model: BP9300T (FCC ID: Q6ZMHEM7145T2) of OMRON HEALTHCARE Co., Ltd. is exempt from RF exposure SAR evaluation as its output power meets the exclusion limits stated in KDB 447498D01(v06). KDB 447498D01(v06) 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)] ꞏ[√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: 5 mm was used in the calculation) and the maximum average output power was 0.8 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 Leader

Test report No. : 14091895H-A-R1 Page : 1 of 38 Issued date : February 3, 2022 FCC ID : Q6ZMHEM7145T2 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 Report Cover Page - 13-EM-F0429 Issue # 19.0 RADIO TEST REPORT Test Report No. : 14091895H-A-R1 Applicant : OMRON HEALTHCARE Co., Ltd. Type of EUT : Blood Pressure Monitor Model Number of EUT : BP9300T FCC ID : Q6ZMHEM7145T2 Test regulation : FCC Part 15 Subpart C: 2021 Test result : Complied (Refer to SECTION 3) Date of test: November 25 to December 14, 2021 Representative test engineer: Kiyoshiro Okazaki Engineer Approved by: Takayuki Shimada Leader CERTIFICATE 5107.02 The testing in which "Non-accreditation" is displayed is outside the accreditation scopes in UL Japan, Inc. There is no testing item of "Non-accreditation". 1. This test report shall not be reproduced in full or partial, without the written approval of UL Japan, Inc. 2. The results in this report appl y only to the sample tested. 3. This sample tested is in compliance with the limits of the above re gulation. 4. The test results in this test report are traceable to the national or international standards. 5. This test report must not be used by the customer to claim product certification, approval, or endorsement by the A2LA accreditation bod y. 6. This test report covers Radio technical requirements. It does not cover administrative issues such as Manual or non-Radio test related Requirements. (if applicable) 7. The all test items in this test report are conducted b y UL Japan, Inc. Ise EMC Lab. 8. The opinions and the interpretations to the result of the description in this report are outside scopes where UL Japan, Inc. has been accredited. 9. The information provided from the customer for this report is identified in Section 1. 10. This report is a revised version of 14091895H-A. 14091895H- A is replaced with this report. Test report No. : 14091895H-A-R1 Page : 2 of 38 Issued date : February 3, 2022 FCC ID : Q6ZMHEM7145T2 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.: 14091895H-A Revision Test report No. Date Page revised Contents - (Ori ginal) 14091895H-A January 24, 2022 - - 1 14091895H-A-R1 February 3, 2022 P.9 Addition of note sentence *1) in clause 4.1 1 14091895H-A-R1 February 3, 2022 P.10 Correction of the model number of the AC Adapter used in Conducted emission and Radiated emission tests of Configuration and peripherals in Clause 4.2 1 14091895H-A-R1 February 3, 2022 P.25 Addition of "* 1)" to 2484 MHz Remarks in Radiated Spurious Emission test data. Test report No. : 14091895H-A-R1 Page : 3 of 38 Issued date : February 3, 2022 FCC ID : Q6ZMHEM7145T2 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 Reference: Abbreviations (Including words undescribed in this report) A2LA The American Association for Laboratory Accreditation LIMS Laboratory Information Management System AC Alternating Current MCS Modulation and Coding Scheme AFH Adaptive Frequency Hopping MRA Mutual Recognition Arrangement AM Amplitude Modulation N/A Not Applicable Amp, AMP Amplifier NIST National Institute of Standards and Technology ANSI American National Standards Institute NS No signal detect. Ant, ANT Antenna NSA Normalized Site Attenuation AP Access Point OBW Occupied BandWidth ASK Amplitude Shift Keying OFDM Orthogonal Frequency Division Multiplexing Atten., ATT Attenuator P/M Power meter AV Average PCB Printed Circuit Board BPSK Binary Phase-Shift Keying PER Packet Error Rate BR Bluetooth Basic Rate PHY Physical Layer BT Bluetooth PK Peak BT LE Bluetooth Low Energy PN Pseudo random Noise BW BandWidth PRBS Pseudo-Random Bit Sequence Cal Int Calibration Interval PSD Power Spectral Density CCK Complementary Code Keying QAM Quadrature Amplitude Modulation Ch., CH Channel QP Quasi-Peak CISPR Comite International Special des Perturbations Radioelectriques QPSK Quadrature Phase Shift Keying CW Continuous Wave RBW Resolution BandWidth DBPSK Differential BPSK RDS Radio Data System DC Direct Current RE Radio Equipment D-factor Distance factor RF Radio Frequency DFS Dynamic Frequency Selection RMS Root Mean Square DQPSK Differential QPSK RNSS Radio Navigation Satellite Service DSSS Direct Sequence Spread Spectrum RSS Radio Standards Specifications DUT Device Under Test Rx Receiving EDR Enhanced Data Rate SA, S/A Spectrum Analyzer EIRP, e.i.r.p. Equivalent Isotropically Radiated Power SG Signal Generator EMC ElectroMagnetic Compatibility SVSWR Site-Voltage Standing Wave Ratio EMI ElectroMagnetic Interference TR, T/R Test Receiver EN European Norm Tx Transmitting ERP, e.r.p. Effective Radiated Power VBW Video BandWidth ETSI European Telecommunications Standards Institute Vert. Vertical EU European Union WLAN Wireless LAN EUT Equipment Under Test Fac. Factor FCC Federal Communications Commission FHSS Frequency Hopping Spread Spectrum FM Frequency Modulation Freq. Frequency FSK Frequency Shift Keying GFSK Gaussian Frequency-Shift Keying GNSS Global Navigation Satellite System GPS Global Positioning System Hori. Horizontal ICES Interference-Causing Equipment Standard IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronics Engineers IF Intermediate Frequency ILAC International Laboratory Accreditation Conference ISED Innovation, Science and Economic Development Canada ISO International Organization for Standardization JAB Japan Accreditation Board LAN Local Area Network Test report No. : 14091895H-A-R1 Page : 4 of 38 Issued date : February 3, 2022 FCC ID : Q6ZMHEM7145T2 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 ...................…

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

Test report No. : 14091895H-A-R1 Page : 35 of 38 Issued date : February 3, 2022 FCC ID : Q6ZMHEM7145T2 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 Conducted Emission Photo 1 Photo 2 Test report No. : 14091895H-A-R1 Page : 36 of 38 Issued date : February 3, 2022 FCC ID : Q6ZMHEM7145T2 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 Radiated Spurious Emission Photo 1 Photo 2 Test report No. : 14091895H-A-R1 Page : 37 of 38 Issued date : February 3, 2022 FCC ID : Q6ZMHEM7145T2 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 Below 1 GHz: (Horizontal: X-axis / Vertical: X-axis) Above 1 GHz: (Horizontal: Z-axis / Vertical: Y-axis) X-axis Y-axis Z-axis Test report No. : 14091895H-A-R1 Page : 38 of 38 Issued date : February 3, 2022 FCC ID : Q6ZMHEM7145T2 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 Antenna Terminal Conducted Tests Photo 1 Photo 2 End of Report