Q6ZHWZ1000TWheezeScan

Wheeze Detector WheezeScan (HWZ-1000T) Instruction Manual NO WHEEZE WHEEZE Rx ONLY 1 Table of Contents Introduction .......................................................................................................2 Safety Instructions .....................................................................................................................................................2 Intended Use ...............................................................................................................................................................2 Receiving and Inspection .......................................................................................................................................2 Important Safety Information ...............................................................................................................................3 1. Know Your Device ..........................................................................................7 1.1 Contents ..................................................................................................................................................................7 1.2 Part Names ............................................................................................................................................................8 2. Installing Batteries ........................................................................................9 3. Detecting Wheeze .......................................................................................10 3.1 Taking a Measurement ....................................................................................................................................10 3.2 Checking Result .................................................................................................................................................14 4. Managing Results with Your Smart Device ...............................................15 5. Maintenance ................................................................................................16 5.1 Maintenance .......................................................................................................................................................16 5.2 Storage ..................................................................................................................................................................16 5.3 Cleaning ...............................................................................................................................................................16 5.4 Disposal ................................................................................................................................................................16 6. Troubleshooting ..........................................................................................17 7. Specifications ...............................................................................................19 8. FCC Statement .............................................................................................21 9. Limited Warranty .........................................................................................22 10. Guidance and Manufacturer’s Declaration .............................................23 11. How the Device Works ...............................................................................25 2 Introduction Thank you for purchasing the OMRON WheezeScan. WheezeScan uses innovative listening technology to identify "wheeze" or "no wheeze" quickly and accurately. WheezeScan is a convenient tool to help parents to manage their children's asthmatic symptoms at home. The cause of these symptoms can be bronchitis, bronchiolitis or bronchial asthma. Safety Instructions This instruction manual provides you with important information about WheezeScan. To ensure safe and proper use of this device, READ and UNDERSTAND all of these instructions. If you do not understand these instructions or have any questions, contact 1-800- 634-4350 before attempting to use this device. Intended Use The OMRON WheezeScan is intended to detect the presence of wheezing in infants, toddlers and children from 4 months to 7 years of age. The WheezeScan shows “Wheeze” or “No Wheeze” as the result of measurement. The obtained results should be discussed with your physician. Environment of use: home, clinic Receiving and Inspection Remove this device and other items from the packaging and inspect for damage. If this device or any other items are damaged, DO NOT USE and contact 1-800-634-4350. 3 Important Safety Information Read the Important Safety Information in this instruction manual before using this device. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about patient’s symptoms, CONSULT WITH A PHYSICIAN. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. WARNING • NEVER diagnose or treat a patient based only on the result from this device. ONLY a physician is qualified to diagnose and treat patient’s respiratory disease. • ONLY apply this device on a patient whose illness was diagnosed as bronchitis, bronchiolitis or bronchial asthma. • Consult with a physician before using this device. This device is intended to be used under the direction of a physician or licensed healthcare professional. • If a patient is having signs and symptoms of chest tightness, shortness of breath, coughing or wheezing, a wheeze may not be detected because: - the breathing sound is too loud or too soft; - the wheeze is at extremely small amplitude, extremely short duration, extremely high frequency or extremely low frequency; - an asthma attack occurs without wheezing. Always take action as prescribed by a physician, no matter what the result from this device is. This device also may incorrectly detect any noise as a wheeze…

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4-1.External Photos 4-1.External Photos4-1.External Photos 4-1.External Photos FRONTRIGHT(*) BACKLEFT TOPBOTTOM ＊In the mass product,all characters and marks are displayed fill, not outline. 121.5mm

6.Label Design and Location FCC ID:Q6ZHWZ1000T Approx.dimensions 1.4mm Areafor displaying standards

4-2.Internal Photos FRONT BACK RF-ICAntenna

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 April 22, 2020 FCC ID: Q6ZHWZ1000T To whom it may concern, We, UL Japan, Inc, hereby declare that WheezeScan, model: RE-W100 (FCC ID: Q6ZHWZ1000T) 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 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 Leader of Ise EMC Lab. Consumer Technology Division UL Japan, Inc.

Test report No. : 13280770H-A Page : 1 of 33 Issued date : April 22, 2020 FCC ID : Q6ZHWZ1000T 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 # 16.0 RADIO TEST REPORT Test Report No. : 13280770H-A Applicant : OMRON HEALTHCARE Co., Ltd. Type of EUT : WheezeScan Model Number of EUT : RE-W100 FCC ID : Q6ZHWZ1000T Test regulation : FCC Part 15 Subpart C: 2019 Test Result : Complied (Refer to SECTION 3.2) Date of test: March 23 and April 2, 2020 Representative test engineer: Hiroyuki Furutaka Engineer Consumer Technology Division Approved by: Takayuki Shimada Leader Consumer Technolo gy Division This report contains data that are not covered by the NVLAP accreditation. 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 apply only to the sample tested. 3. This sample tested is in compliance with the limits of the above regulation. 4. The test results in this test report are traceable to the national or international standards. 5. This test report covers Radio technical requirements. It does not cover administrative issues such as Manual or non-Radio test related Requirements. (if applicable) 6. The all test items in this test report are conducted by UL Japan, Inc. Ise EMC Lab. 7. This test report must not be used by the customer to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. 8. The information provided from the customer for this report is identified in SECTION 1. This laboratory is accredited by the NVLAP LAB CODE 200572-0, U.S.A. The tests reported herein have been performed in accordance with its terms of accreditation. *As for the range of Accreditation in NVLAP, you may refer to the WEB address, http://japan.ul.com/resources/emc_accredited/ Test report No. : 13280770H-A Page : 2 of 33 Issued date : April 22, 2020 FCC ID : Q6ZHWZ1000T 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.: 13280770H-A Revision Test report No. Date Page revised Contents - (Ori ginal) 13280770H-A April 22, 2020 - - Test report No. : 13280770H-A Page : 3 of 33 Issued date : April 22, 2020 FCC ID : Q6ZHWZ1000T 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 MCS Modulation and Coding Scheme AC Alternating Current MRA Mutual Recognition Arrangement AFH Adaptive Frequency Hopping N/A Not Applicable AM Amplitude Modulation NIST National Institute of Standards and Technology Amp, AMP Amplifier NS No signal detect. ANSI American National Standards Institute NSA Normalized Site Attenuation Ant, ANT Antenna NVLAP National Voluntary Laboratory Accreditation Program AP Access Point OBW Occupied Band Width 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 Quadri-Phase Shift Keying CW Continuous Wave RBW Resolution Band Width 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 RSS Radio Standards Specifications DSSS Direct Sequence Spread Spectrum 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 Test Receiver EN European Norm Tx Transmitting ERP, e.r.p. Effective Radiated Power VBW Video BandWidth EU European Union Vert. Vertical EUT Equipment Under Test WLAN Wireless LAN 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 LIMS Laboratory Information Management System Test report No. : 13280770H-A Page : 4 of 33 Issued date : April 22, 2020 FCC ID : Q6ZHWZ1000T 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 ....................................................................................................... 5 SECTION 2: Equipment under test (EUT) ............................................................................................ 5 SECTION 3: Test specification, procedures & results .......................................................................... 6 SECTION 4: Operation of EUT during testing ................................................…

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Test report No. : 13280770H-A Page : 32 of 33 Issued date : April 22, 2020 FCC ID : Q6ZHWZ1000T 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. : 13280770H-A Page : 33 of 33 Issued date : April 22, 2020 FCC ID : Q6ZHWZ1000T 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