2AFB3WA-WEC100RetinaVue 100 Imager Kit

Welch Allyn RetinaVue™ 100 Imager Directions for use Software version 4.6.XX © 2016 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual. Prescription only or "For Use by or on the order of a licensed medical professional." Software in this product is Copyright 2015 Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse- engineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors. For information about any Welch Allyn product, contact Welch Allyn Technical Support: http://www.welchallyn.com/ support. 411492, (printed copy) DIR 80019780 Ver. C Revision date: 2016-01 This manual applies to the 901103 Fundus Camera Manufactured for Welch Allyn, Inc. Medimaging Integrated Solution Inc. (MiiS) 1F, No. 7, R&D Rd II, Hsinchu Science Park, Hsinchu, TAIWAN 30076, R.O.C. Obelis S.A. Bd. General Wahis 53,1030, Brussels, Belgium Made in Taiwan Contents Symbols ................................................................................................... 1 Introduction ............................................................................................. 5 Intended use ........................................................................................................ 5 About warnings and cautions ............................................................................... 5 General warnings and cautions ............................................................................ 5 Controls and connectors ...................................................................................... 7 RetinaVue 100 Imager Home screen ................................................................... 8 Using the RetinaVue 100 Imager ......................................................... 17 Unpack the system ............................................................................................ 17 Docking station .................................................................................................. 23 Patient data management .................................................................................. 25 Perform an eye exam using the Auto exam mode ............................................ 28 Perform a manual image capture while in Auto exam mode ............................. 34 Skip an image capture while in Auto exam mode .............................................. 35 Perform a manual image capture while in Manual exam mode ......................... 36 Update the RetinaVue 100 Imager software ..................................................... 38 Viewing or changing the RetinaVue 100 Imager settings .................................. 39 Troubleshooting .................................................................................... 41 Maintenance .......................................................................................... 45 Clean and disinfect ............................................................................................. 45 Specifications ........................................................................................ 47 Device radio ........................................................................................... 49 General compliance and standards ..................................................... 51 General radio compliance ................................................................................... 51 Approved accessories ........................................................................... 57 Accessories ....................................................................................................... 57 Warranty ................................................................................................ 59 iii iv ContentsWelch Allyn RetinaVue™ 100 Imager Symbols Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning symbols will appear with a grey background in a black and white document. Caution The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. Consult Directions for Use Power symbols Power button Direct current (DC) Rated power input, DCRated power output, DC FuseRechargeable battery Battery Charging - Non-AC powered Connectivity symbols USB Wireless signal strength (requires optional software) •Best (4 bars) •Good (3 bars) •Fair (2 bars) •Weak (1 bar) •No signal (no bars) 1 • No connection (X) Shipping, storing, and environment symbols Temperature limit Keep Dry Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste. Fragile Humidity limitation Atmospheric pressure limitation This way upStacking limit by number Recyclable Miscellaneous symbols Product Identifier Reorder Number Global Trade Item NumberFor indoor use…

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

Report No.：T150917S01 Page 1 of 7 External Photo Report No.：T150917S01 Page 2 of 7 Report No.：T150917S01 Page 3 of 7 Report No.：T150917S01 Page 4 of 7 Report No.：T150917S01 Page 5 of 7 Power Cable Report No.：T150917S01 Page 6 of 7 Power Adapter (Model : 3A-10AWU05) Report No.：T150917S01 Page 7 of 7

Label location of Unit Label location of package

Report No.：T150917S01 Page 1 of 11 Internal Photo Report No.：T150917S01 Page 2 of 11 Report No.：T150917S01 Page 3 of 11 Report No.：T150917S01 Page 4 of 11 Report No.：T150917S01 Page 5 of 11 Report No.：T150917S01 Page 6 of 11 Report No.：T150917S01 Page 7 of 11 Report No.：T150917S01 Page 8 of 11 Report No.：T150917S01 Page 9 of 11 Report No.：T150917S01 Page 10 of 11 Report No.：T150917S01 Page 11 of 11

Compliance Certification Services Inc. Report No: T151012S01-SF Note: This report shall not be reproduced except in full, without the written approval of Compliance Certification Services Inc. This document may be altered or revised by Compliance Certification Services Inc. personnel only, and shall be noted in the revision section of the document. Page 1 Total Page: 35 Rev. 01 ANSI/IEEE Std. C95.1-2005 in accordance with the requirements of FCC Report and Order: ET Docket 93-62 FCC TEST REPORT For RetinaVue 100 Imager Kit Model: RetinaVue 100 Imager Issued to Medimaging Integrated Solution Inc. 1F,No.7, R&D Rd. II, Hsinchu Science Park, Hsinchu, Taiwan 30076, R.O.C. Issued by Compliance Certification Services Inc. No.11, Wugong 6th Rd., Wugu Dist., New Taipei City 24891, Taiwan. (R.O.C.) http://www.ccsrf.com [email protected] Issued Date: 2015/12/29 Compliance Certification Services Inc. Report No: T151012S01-SF Page 2 Rev. 01 Revision History Rev. Issue Date Revisions Effect Page Revised By 00 2015/11/19 Initial Issue ALL Tony Liao 01 2015/12/29 Revise date of test Revise summary of highest SAR values Revise summary of SAR test exclusion configurations Add simulating liquids parameter check results Add system performance check results Add SAR measurements results 4, 6,22, 23, 27, 29, 32 Tony Liao Compliance Certification Services Inc. Report No: T151012S01-SF Page 3 Rev. 01 Table of Contents 1 Certificate of Compliance (SAR Evaluation) ............................................................... 4 2 Description of Equipment Under Test ...................................................................... 5 2.1 Revise Summary of Highest SAR Values .............................................................................................. 6 3 Requirements for Compliance Testing Defined .......................................................... 7 3.1 Requirements for Compliance Testing Defined by the FCC ................................................................. 7 4 Dosimetric Assessment System ................................................................................ 8 4.1 Measurement System Diagram ........................................................................................................... 9 4.2 System Components .......................................................................................................................... 10 5 Evaluation Procedures ........................................................................................... 13 6 SAR Measurement Procedures ............................................................................... 15 6.1 Normal SAR Test Procedure ............................................................................................................... 15 7 Measurement Uncertainty ..................................................................................... 17 8 Device Under Test ................................................................................................. 18 8.1 Wireless Technologies ....................................................................................................................... 18 8.2 Maximum Tune-up Power ................................................................................................................. 19 8.3 Simultaneous Transmission ............................................................................................................... 20 9 Summary of SAR Test Exclusion Configurations ....................................................... 21 9.1 Standalone SAR Test Exclusion Calculations ...................................................................................... 21 9.1.1 Revise Calculations Threshold for Wi-Fi Antenna < 50mm from the User ........................................ 22 9.1.2 Revise of SAR Required Test Configuration ....................................................................................... 23 10 Exposure Limit ...................................................................................................... 24 11 Tissue Dielectric Properties .................................................................................... 25 11.1 Test Liquid Confirmation ................................................................................................................... 25 11.2 Typical Composition of Ingredients for Liquid Tissue Phantoms ....................................................... 26 11.3 Addition Simulating Liquids Parameter Check Results ...................................................................... 27 12 System Performance Check .................................................................................... 28 12.1 Revise System Performance Check Results ....................................................................................... 29 13 RF Output Power Measurement ............................................................................. 30 13.1 Wi-Fi (2.4GHz Band) ........................................................................................................................... 31 14 Revice SAR Measurements Results ......................................................................... 32 15 Equipment List & Calibration Status ....................................................................... 33 16 Facilities ............................................................................................................... 34 17 Reference ............................................................................................................. 34 18 Attachments ......................................................................................................... 35 Compliance Certification Services Inc. Report No: T151012S01-SF Page 4 Rev. 01 1 Certificate of Compliance (SAR Evaluation) Applicant Medimaging Integrated Solution Inc. 1F,No.7, R&D Rd. II, Hsinchu Science Park, Hsinchu, Taiwan 30076, R.O.C. Equipment Under Test: …

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

Test Laboratory: Compliance Certification Service Inc. SAR Lab 02 Date/Time: 12/29/2015 Wi-Fi 2.4GHz Band Frequency: 2412 MHz; Duty Cycle: 1:1; Room Ambient Temperature: 24.0C; Liquid Temperature: 23.0C Medium parameters used: f = 2412.7 MHz; σ = 1.93 mho/m; ε r = 52.2; ρ = 1000 kg/m 3 ; DASY4 Configuration: - Area Scan setting - Find Secondary Maximum Within: 2.0 dB and with a peak SAR value greater than 0.0012W/kg - Electronics: DAE4 Sn558; Calibrated: 7/16/2015 - Probe: EX3DV4 - SN3554; ConvF(6.1, 6.1, 6.1); Calibrated: 10/1/2015 - Sensor-Surface: 2mm (Mechanical Surface Detection) - Phantom: Flat Phantom ELI4.0; Type: QDOVA001BA; Serial: SN: 1052 Front/Main Ant/802.11b/ch1_Repeat/Area Scan (6x7x1): Measurement grid: dx=12mm, dy=12mm Maximum value of SAR (measured) = 1.29 mW/g Front/Main Ant/802.11b/ch1_Repeat/Zoom Scan (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm, dz=5mm Reference Value = 19.3 V/m; Power Drift = -0.008 dB Peak SAR (extrapolated) = 1.96 W/kg SAR(1 g) = 0.945 mW/g; SAR(10 g) = 0.425 mW/g Maximum value of SAR (measured) = 1.43 mW/g Test Laboratory: Compliance Certification Service Inc. SAR Lab 02 Date/Time: 12/29/2015 Wi-Fi 2.4GHz Band Frequency: 2412 MHz; Duty Cycle: 1:1 Front/Main Ant/802.11b/ch1_Repeat/Z Scan (1x1x21): Measurement grid: dx=20mm, dy=20mm, dz=5mm Maximum value of SAR (measured) = 0.685 mW/g

Test Laboratory: Compliance Certification Service Inc. SAR Lab 02 Date/Time: 11/19/2015 20151119_System Check_Dipole2450 sn728 Frequency: 2450 MHz; Duty Cycle: 1:1; Room Ambient Temperature: 24.0C; Liquid Temperature: 23.0C Medium parameters used (interpolated): f = 2450 MHz; σ = 1.88 mho/m; ε r = 52.3; ρ = 1000 kg/m 3 ; DASY4 Configuration: - Area Scan setting - Find Secondary Maximum Within: 2.0 dB and with a peak SAR value greater than 0.0012W/kg - Electronics: DAE4 Sn558; Calibrated: 7/16/2015 - Probe: EX3DV4 - SN3554; ConvF(6.1, 6.1, 6.1); Calibrated: 10/1/2015 - Sensor-Surface: 2mm (Mechanical Surface Detection) - Phantom: Flat Phantom ELI4.0; Type: QDOVA001BA; Serial: SN: 1052 Body/Pin=100mW, d=10mm/Area Scan (8x9x1): Measurement grid: dx=15mm, dy=15mm Info: Interpolated medium parameters used for SAR evaluation. Maximum value of SAR (measured) = 5.60 mW/g Body/Pin=100mW, d=10mm/Zoom Scan (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm, dz=5mm Reference Value = 63.5 V/m; Power Drift = 0.038 dB Peak SAR (extrapolated) = 9.88 W/kg SAR(1 g) = 5.05 mW/g; SAR(10 g) = 2.4 mW/g Info: Interpolated medium parameters used for SAR evaluation. Maximum value of SAR (measured) = 7.43 mW/g 0 dB = 7.43mW/g Test Laboratory: Compliance Certification Service Inc. SAR Lab 02 Date/Time: 11/19/2015 20151119_System Check_Dipole2450 sn728 Frequency: 2450 MHz; Duty Cycle: 1:1 Body/Pin=100mW, d=10mm/Z Scan (1x1x21): Measurement grid: dx=20mm, dy=20mm, dz=5mm Info: Interpolated medium parameters used for SAR evaluation. Maximum value of SAR (measured) = 5.58 mW/g

Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 1 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. FCC 47 CFR PART 15 SUBPART C AND ANSI C63.10:2013 TEST REPORT For RetinaVue 100 Imager Kit Model: RetinaVue 100 Imager Trade Name: Welch Allyn Issued for Medimaging Integrated Solution Inc. 1F,No.7, R&D Rd. II, Hsinchu Science Park, Hsinchu, Taiwan 30076, R.O.C. Issued by Compliance Certification Services Inc. Hsinchu Lab. No.989-1, Wenshan Rd., Shangshan Village, Qionglin Township, Hsinchu County 30741, Taiwan (R.O.C.) TEL: +886-3-5921698 FAX: +886-3-5921108 http://www.ccsrf.com E-Mail: [email protected] Issued Date: December 23, 2015 Note: This report shall not be reproduced except in full, without the written approval of Compliance Certification Services Inc. This document may be altered or revised by Compliance Certification Services Inc. personnel only, and shall be noted in the revision section of the document. The client should not use it to claim product endorsement by TAF or any government agencies. The test results of this report relate only to the tested sample identified in this report. Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 2 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. Revision History Rev. Issue Date Revisions Effect Page Revised By 00 12/18/2015 Initial Issue All Page 93 Gloria Chang 01 12/23/2015 Added KDB Rule in Report P.8 Gloria Chang Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 3 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. TABLE OF CONTENTS TITLE PAGE NO. 1. TEST REPORT CERTIFICATION ................................................................................... 4 2. EUT DESCRIPTION ........................................................................................................ 5 3. DESCRIPTION OF TEST MODES .................................................................................. 7 4. TEST METHODOLOGY .................................................................................................. 8 5. FACILITIES AND ACCREDITATION .............................................................................. 8 5.1 FACILITIES ............................................................................................................... 8 5.2 ACCREDITATIONS ................................................................................................... 8 5.3 MEASUREMENT UNCERTAINTY ............................................................................ 9 6. SETUP OF EQUIPMENT UNDER TEST ........................................................................ 10 7. FCC PART 15.247 REQUIREMENTS ............................................................................. 12 7.1 6dB BANDWIDTH ..................................................................................................... 12 7.2 MAXIMUM PEAK OUTPUT POWER ........................................................................ 22 7.3 AVERAGE POWER ................................................................................................... 25 7.4 POWER SPECTRAL DENSITY ................................................................................. 27 7.5 CONDUCTED SPURIOUS EMISSION ..................................................................... 38 7.6 RADIATED EMISSION .............................................................................................. 51 7.7 CONDUCTED EMISSION ......................................................................................... 85 8. APPENDIX SETUP PHOTOS ......................................................................................... 90 Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 4 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. 1. TEST REPORT CERTIFICATION Applicant ： Medimaging Integrated Solution Inc. Address ： 1F,No.7, R&D Rd. II, Hsinchu Science Park, Hsinchu, Taiwan 30076, R.O.C. Equipment Under Test ： RetinaVue 100 Imager Kit Model ： RetinaVue 100 Imager Trade Name ： Welch Allyn Tested Date ： September 17 ~ November 09, 2015 APPLICABLE STANDARD Standard Test Result FCC Part 15 Subpart C AND ANSI C63.10:2013 PASS WE HEREBY CERTIFY THAT: The above equipment has been tested by Compliance Certification Services Inc., and found compliance with the requirements set forth in the technical standards mentioned above. The results of testing in this report apply only to the product/system, which was tested. Other similar equipment will not necessarily produce the same results due to production tolerance and measurement uncertainties. Approved by: Reviewed by: Sb. Lu Gundam Lin Sr. Engineer Sr. Engineer Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 5 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. 2. EUT DESCRIPTION Product Name RetinaVue 100 Imager Kit Model Number RetinaVue 100 Imager Identify Number T150917S01 Received Date September 17, 2015 Frequency Range IEEE 802.11b/g, 802.11gn HT20 Mode: 2412MHz ~ 2462MHz IEEE 802.11gn HT40 Mode: 2422MHz ~ 2452MHz Transmit Power IEEE 802.11b Mode: 19.19 dBm (0.0830 W) IEEE 802.11g Mode: 23.67 dBm (0.2328 W) IEEE 802.11gn HT20 Mode: 22.63 dBm (0.1832 W) IEEE 802.11gn HT40 Mode: 22.01 dBm (0.1589 W) Channel Spacing 5MHz Channel Number IEEE 802.11b/g, 802.11gn HT20 Mode: 11 Channels IEEE 802.11gn HT40 Mode: 7 Channels Transmit Data Rate IEEE 802.11b Mode: up to 11 Mbps IEEE 802.11g Mode: up to 54 Mbps IEEE 802.11gn HT20 Mode (8…

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

Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 90 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. 8. APPENDIX SETUP PHOTOS RADIATED EMISSION SETUP Below 1GHz Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 91 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. Above 1GHz Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 92 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. ANTENNA PORT CONDUCTED RF MEASUREMENT SETUP Compliance Certification Services Inc. FCC ID: 2AFB3WA-WEC100 Report No.：T150917S01-RP1 Page 93 / 93 This report shall not be reproduced, except in full, without the written approval of Compliance Certification Services Inc. CONDUCTED EMISSION SETUP

Compliance Certification Services Inc. Report No.: T151012S01-SF Rear Surface45.4 Front Surface5.7 WLAN Antenna Separation Distance (mm) WLAN Ant 45.4 mm 93.53 mm 5.7mm mm 11.67mm mm SETUP PHOTOS Rear Front Test Mode Photos