2A92L-A101Bilimonitor Jaundice Meter

1 / 19 2 / 19 Thank you for choosing BJM-20 transcutaneous jaundice meter. This manual provides detailed instructions on the usage, functionality, and features of the BJM-20 transcutaneous jaundice meter. Please read this manual carefully before use. Product Name: Bilimonitor Jaundice Meter Model: BJM-20 Product Registration Certificate Number (China): 20212071690 Production License Number (China): 20214579 Registered/Manufacturing Company Name: E3A Healthcare Pte Ltd Registered Company Address: 83 Science Park Drive #02-03 The Curie Singapore (118258) Production Address: 2nd Floor, No.83 Pinghuan Industrial City, Pinghuan Community, Maluan Street, Pingshan District, Shenzhen City, China Production Date: As indicated on the product label or certificate of conformity Product Lifecycle: 3 years Contact Us: Customer Service Centre Hotline: +65-6236-6400 (Monday to Friday, 9:00 am to 6:00 pm) Email: [email protected] or contact your local dealer For more information, please visit E3A Healthcare's website at: www.e3ahealth.com The release date of this manual is October 2021, version V1.0.0 3 / 19 Table of Contents 1 Overview.................................................................. 4 1.1 Expected Usage and Operating Environment ................................ 4 1.1.1 Expected Usage .................................................... 4 1.1.2 Contraindications ................................................... 4 1.1.3 Intended Use ....................................................... 4 1.2 Standard Configuration List ................................................ 4 1.3 Product Dimensions ...................................................... 4 1.4 Storage Environment ..................................................... 4 1.5 Operating Environment .................................................... 5 1.6 Transportation ........................................................... 5 1.7 Warning Symbols ......................................................... 5 2 Product Introduction ........................................................ 5 2.1 Working Principle ......................................................... 5 2.2 Product Composition ...................................................... 5 2.3 Structure and Functions ................................................. 5 2.3.1 Front Panel ........................................................ 5 2.3.2 Rear Panel ........................................................ 6 2.3.3 Legend Display ..................................................... 6 2.4 Main Performance Parameters ............................................. 7 2.5 The following parameters of the instrument are considered basic performance parameters: ................................................................. 8 3 User Manual............................................................... 8 3.1 Activating the Instrument .................................................. 8 3.2 App Introduction .......................................................... 8 3.3 App Connection .......................................................... 9 3.4 Starting Measurement .................................................... 9 3.5 Powering Off ............................................................ 10 3.6 Battery Inspection and Replacement ....................................... 10 3.7 Precautions for Use ...................................................... 11 4 Maintenance and Care ..................................................... 11 4.1 Daily Inspection ......................................................... 11 4.2 Storage Method ......................................................... 12 4.3 Maintenance and Care ................................................... 12 4.4 Service Life ............................................................. 12 5 Symbol Explanation ....................................................... 12 6 After-sales Service ........................................................ 12 7 Warranty Card ............................................................ 14 8 Attachment C FCC Caution ................................................. 14 9 Attachment C ELECTROMAGNETIC COMPATIBILITY ......................... 15 C.1 Components information ................................................. 16 C.2 RF Transmitting ......................................................... 17 C.3 IMMUNITY TEST LEVELS ............................................... 17 4 / 19 1 Overview 1.1 Expected Usage and Operating Environment 1.1.1 Expected Usage Used to measure serum bilirubin levels in neonates before, during, and after phototherapy. 1.1.2 Contraindications No known contraindications. 1.1.3 Intended Use The transcutaneous jaundice meter (BJM-20) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit pro-vides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants. The device is intended for use in hospitals, clinics or doctor’s offices under a physicians supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbiliru-binemia. It is to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose the transcutaneous jaundice meter (BJM-20) test results are indicative of hy-perbilirubinemia should be evaluated by their physician(s) for appropriate patient management. Specific neonatal patient Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. The transcutaneous jaundice meter (BJM-20) is a prescription medical device The transcutaneous jaundice meter (BJM-20)is not intended for home use. The transcutaneous jaundice meter (BJM-20) may only be used at the sternum measurement site for Physician’s office applications. 1.2 Standard Configuration List Instru…

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EXTERNAL PHOTOS

INTERNAL PHOTOS

FCC ID: 2A92L-A101 RF Exposure Evaluation REQUIREMENT KDB447498 D01 General RF Exposure Guidance v06, Clause 4.3.1(a) [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 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 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 according to 4.1 f) is applied to determine SAR test exclusion. TEST RESULT Passed Not Applicable Radio Type Frequency range (MHz) Conducted Peak Power (dBm) Maximum Tune-up (dBm) Calculating data Limit Result BLE 2402-2480 -2.38 -2.00 0.1960 3.00 Pass Note: 1) The maximum antenna gain is 1.8dBi 2) The exposure evaluation safety distance is 5mm.

Page: 1 of 30 TEST REPORT For Bluetooth-LE Report No. ...................................... : CHTEW23020002 Report Verification: Project No.................................： SHT2211065401EW FCC ID ............................................. : 2A92L-A101 Applicant’s name ........................... : E3A Healthcare Pte Ltd Address ............................................. : 83 SCIENCE PARK DRIVE #02-03 THE CURIE SINGAPORE (118258) Product Name ................................ : Bilimonitor Jaundice Meter Trade Mark ....................................... : - Model No. ......................................... : BJM-20 Listed Model(s) ................................. : - Standard ......................................... : FCC CFR Title 47 Part 15 Subpart C Section 15.247 Date of receipt of test sample..........: Jan. 05, 2023 Date of testing.............................: Jan. 06, 2023- Jan. 31, 2023 Date of issue...............................: Feb. 01, 2023 Result .................. ........................: PASS Compiled by ( Position+Printed name+Signature): File administrator Silvia Li Supervised by (Position+Printed name+Signature): Project Engineer Kiki Kong Approved by (Position+Printed name+Signature): RF Manager Hans Hu Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................. : 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd. takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. The test report merely correspond to the test sample. Report No.: CHTEW23020002 Page: 2 of 30 Date of issue: 2023-02-01 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) Contents 1. TEST S T AN D AR D S A N D R E P O R T VERS I O N 3 1.1. Test Standards 3 1.2. Report version 3 2. TEST DESCRIPTION 4 3. SUMMARY 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Radio Specification Description 5 3.4. Testing Laboratory Information 6 4. TEST CONFIGURATION 7 4.1. Test frequency list 7 4.2. Descriptions of Test mode 7 4.3. Test sample information 7 4.4. Support unit used in test configuration and system 8 4.5. Testing environmental condition 8 4.6. Statement of the measurement uncertainty 8 4.7. Equipment Used during the Test 9 5. TEST CONDITIONS AND RESULTS 10 5.1. Antenna Requirement 10 5.2. AC Conducted Emission 11 5.3. Peak Output Power 12 5.4. Power Spectral Density 13 5.5. 6dB bandwidth 14 5.6. 99% Occupied Bandwidth 15 5.7. Duty Cycle 16 5.8. Conducted Band edge and Spurious Emission 17 5.9. Radiated Band edge Emission 18 5.10. Radiated Spurious Emission 20 6. TEST SETUP PHOTOS 25 7. EXTERNAL AND INTERNAL PHOTOS 27 8. APPENDIX REPORT 30 Report No.: CHTEW23020002 Page: 3 of 30 Date of issue: 2023-02-01 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 1. TEST STAND ARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: ‒ FCC Rules Part 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation within the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz ‒ ANSI C63.10:2013: American National Standard for Testing Unlicensed Wireless Devices ‒ KDB 558074 D01 15.247 Meas Guidance v05r02: Guidance for Compliance Measurements on Digital Transmission System, Frequency Hopping Spread Spectrum System, and Hybrid System Devices Operating under Section 15.247 of The FCC Rules 1.2. Report version Revision No. Date of issue Description N/A 2023-02-01 Original Report No.: CHTEW23020002 Page: 4 of 30 Date of issue: 2023-02-01 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 2. TEST DESCRIPTION Report clause Test Items Standard Requirement Result Test Engineer 5.1 Antenna Requirement 15.203/15.247(c) PASS Xiaoxiao Li 5.2 AC Conducted Emission 15.207 N/A N/A 5.3 Peak Output Power 15.247(b)(3) PASS Xiaoxiao Li 5.4 Power Spectral Density 15.247(e) PASS Xiaoxiao Li 5.5 6dB Bandwidth 15.247(a)(2) PASS Xiaoxiao Li 5.6 99% Occupied Bandwidth - PASS *1 Xiaoxiao Li 5.7 Duty cycle - PASS *1 Xiaoxiao Li 5.8 Conducted Band Edge and Spurious Emission 15.247(d)/15.205 PASS Xiaoxiao Li 5.9 Radiated Band Edge Emission 15.205/15.209 PASS Jianquan Wu 5.10 Radiated Spurious Emission 15.247(d)/15.205/15.209 PASS Jianquan Wu Note: ‒ The measurement uncertainty is not included in the test result. ‒ *1: No requirement on standard, only report these test data. Report No.: CHTEW23020002 Page: 5 of 30 Date of issue: 2023-02-01 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 3. SUMMARY 3.1. Client Information Applicant: E3A Healthcare Pte Ltd Address: 83 SCIENCE PARK DRIVE #02-03 THE CURIE SINGAPORE (118258) Manufacturer: E3A Healthcare Pte Ltd Address: 83 SCIENCE PARK DRIVE #02-03 THE CURIE SINGAPORE (118258) 3.2. Product Description Main unit information: Product Name: Bilimonitor Jaundice Meter Trade Mark: - Model No.: BJM-20 Listed Model(s): - Power supply: DC 3.0V from Battery Hardware version: V2.1 Software version: V1.2.6 3.3. Radio Specification Description Bluetooth version: V4.0 Support function *2 : BLE Modulation: GFSK Operation frequency: 2402MHz~2480MHz Channel number: 40 Channel separation: 2MHz Antenna type: PCB Antenna Antenna gain: 1.8dBi Note: *2: only show the RF function associated with this report. Report No.: CHTEW23020002 Page: 6 of 30 Date of issue: 2023…

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Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 1 of 14 APPENDIX REPORT Project No. SHT2211065401EW Radio Specification Bluetooth BLE Test sample No. YPHT22110654005 Model No. BJM-20 Start test date 2023-01-09 Finish date 2023-01-09 Temperature 24.1°C Humidity 54% Test Engineer Xiaoxiao Li Auditor Appendix clause Test item Result A Peak Output Power PASS B Power Spectral Density PASS C 6 dB Bandwidth PASS D 99% Occupied Bandwidth PASS E Duty cycle PASS F Band edge and Spurious Emissions (conducted) PASS Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 2 of 14 Appendix A：Peak Output Power Type Channel Peak Output power (dBm) Average Output power (dBm) Limit (dBm) Result BT-BLE 00 -2.86 -2.90 ≤ 30.00 Pass 19 -2.38 -2.69 39 -3.02 -3.03 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 3 of 14 CH00 Date: 9.JAN.2023 13:57:24 CH19 Date: 9.JAN.2023 14:00:28 CH39 Date: 9.JAN.2023 14:02:32 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 4 of 14 Appendix B：Power Spectral Density Type Channel Power Spectral Density(dBm/3KHz) Limit (dBm/3KHz) Result BT-BLE 00 -17.89 ≤8.00 Pass 19 -18.07 39 -18.50 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 5 of 14 CH00 Date: 9.JAN.2023 13:58:25 CH19 Date: 9.JAN.2023 14:01:04 CH39 Date: 9.JAN.2023 14:03:21 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 6 of 14 Appendix C：6dB bandwidth Type Channel 6dB Bandwidth(kHz) Limit (kHz) Result BT-BLE 00 796.00 ≥500 Pass 19 782.00 39 792.00 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 7 of 14 CH00 Date: 9.JAN.2023 13:57:03 CH19 Date: 9.JAN.2023 14:00:11 CH39 Date: 9.JAN.2023 14:02:15 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 8 of 14 Appendix D：99% Occupied Bandwidth Type Channel 99% Occupied Bandwidth(MHz) Limit (kHz) Result BT-BLE 00 1.04 - Pass 19 1.05 39 1.05 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 9 of 14 CH00 Date: 9.JAN.2023 13:57:15 CH19 Date: 9.JAN.2023 14:00:19 CH39 Date: 9.JAN.2023 14:02:23 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 10 of 14 Appendix E：Duty cycle Test Frequency （MHz） T on time for single burst (ms) T period (ms) Duty cycle 1/T on time (kHz) 2440 0.39 0.62 62.9% 2.6 Date: 9.JAN.2023 13:59:58 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 11 of 14 Appendix F：Band edge and Spurious Emissions (conducted) Test Item: Band edge CH00 Date: 9.JAN.2023 13:58:35 CH39 Date: 9.JAN.2023 14:03:31 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 12 of 14 Test Item: SE CH00 Reference level Date: 9.JAN.2023 13:58:43 CH00 30MHz~1000MHz Date: 9.JAN.2023 13:58:59 CH00 1GHz~26GHz Date: 9.JAN.2023 13:59:16 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 13 of 14 CH19 Reference level Date: 9.JAN.2023 14:01:10 CH19 30MHz~1000MHz Date: 9.JAN.2023 14:01:26 CH19 1GHz~26GHz Date: 9.JAN.2023 14:01:43 Project No.: SHT2211065401EW Radio Specification: Bluetooth BLE Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 14 of 14 CH39 Reference level Date: 9.JAN.2023 14:04:56 CH39 30MHz~1000MHz Date: 9.JAN.2023 14:05:12 CH39 1GHz~26GHz Date: 9.JAN.2023 14:05:28 --------End of Report--------

BJM-20 Antenna Specification 1. Antenna description: Antenna plate Monopole antenna Make name/model name YSJ-20-MAIN-V2.1 Antenna gain 1.8dBi Frequency range 2.4GHZ-2.483GHZ Connector type direct Location of measurement (company name) SHENZHEN JLC ELECTRONICS CO.,LTD. 2. External view drawing: Picture of antenna (TOP view) 3. Antenna Radiation Pattern 1) Main antenna : 2402 MHz a) Horizontal Frequency(MHZ) 2402 Antenna Polarity Horizontal Maximum Value(dBi) 1.8 Average Gain(dBi) -1.42 Minimum Gain(dBi) -61.26 b) Vertical Frequency(MHZ) 2402 Antenna Polarity Vertical Maximum Value(dBi) -2.99 Average Gain(dBi) -11.5 Minimum Gain(dBi) -63.1 2) Main antenna : 2441 MHz a) Horizontal Frequency(MHZ) 2441 Antenna Polarity Horizontal Maximum Value(dBi) 1.59 Average Gain(dBi) -1.41 Minimum Gain(dBi) -57.8 b) Vertical Frequency(MHZ) 2441 Antenna Polarity Vertical Maximum Value(dBi) -3.9 Average Gain(dBi) -11.5 Minimum Gain(dBi) -55.3 3) Main antenna : 2480MHz a) Horizontal Frequency(MHZ) 2480 Antenna Polarity Horizontal Maximum Value(dBi) 1.43 Average Gain(dBi) -2.44 Minimum Gain(dBi) -53.04 b) Vertical Frequency(MHZ) 2480 Antenna Polarity Vertical Maximum Value(dBi) -5.38 Average Gain(dBi) -12.61 Minimum Gain(dBi) -50.12

TEST SETUP PHOTOS Radiated Emission