YTKPC-68AWrist Oximeter

User Manual for OW1.0 Wrist Oximeter I User Manual Wrist Oximeter Model: PC-68A Brand: Boston Life Labs User Manual for OW1.0 Wrist Oximeter II Instructions to User OW1.0 Wrist Oximeter is a precision measuring device, please read the manual very carefully before using this device. Failure to follow these instructions may cause measuring abnormality or device damage. The Manual is published in English and Boston Life Labs LLC. has the ultimate right to explain the Manual. No part of this manual may be photocopied, reproduced or translated into another language without the prior written consent. Boston Life Labs LLC. reserves the right to improve and amend it at any time without prior notice. Version of This Manual: Ver 1.0 All rights reserved. User Manual for OW1.0 Wrist Oximeter III Notes z The contents contained in this manual are subject to change without prior notice. z Information furnished by Boston Life Labs is believed to be accurate and reliable. However, no responsibility is assumed by us for its use, or any infringements of patents or other rights of third parties that may result from its use. Instructions for Safe Operations 0 Check the device to make sure that there is no visible damage that may affect user’s safety or measurement performance with regard to sensors and clips. It is recommended that the device should be inspected minimally once a week. When there is obvious damage, stop using the device. 0 Necessary maintenance must be performed only by qualified service technicians. Users are not permitted to maintain it by themselves. 0 The oximeter cannot be used together with devices not specified in User Manual. Cautions 0 Explosive hazard—DO NOT use the oximeter in environment with inflammable gas such as some User Manual for OW1.0 Wrist Oximeter IV ignitable anesthetic agents. 0 DO NOT use the oximeter while the testee is under MRI or CT scanning. Warnings 0 An uncomfortable or painful feeling may appear if using the oximeter continuously on the same place for a long time, especially for poor microcirculation patients. It is recommended that the oximeter should not be applied to the same location for longer than 2 hours. If any abnormal condition is found, please change the position of oximeter. 0 DO NOT clip this device on edema or tender tissue. 0 The light (the infrared light is invisible) emitted from the device is harmful to the eyes, so service technician or testee should not stare at the light. 0 The local law must be followed when disposing of the device. Attentions  Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.  The device should be kept out of the reach of children. User Manual for OW1.0 Wrist Oximeter V  If the oximeter gets wet, please stop using it and do not resume operation until it is dry. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately.  DO NOT operate the button on the front panel with sharp materials.  High temperature or high pressure steam disinfection to the oximeter is not permitted. Refer to related chapter for instructions of cleaning and disinfection. User Manual for OW1.0 Wrist Oximeter VI Table of Contents 1 OVERVIEW .................................................................... 1 1.1 Appearance................................................................ 1 1.2 Name and Model....................................................... 2 1.3 Conformation............................................................ 3 1.4 Features...................................................................... 3 1.5 Intended Use.............................................................. 4 1.6 Key of Symbols.......................................................... 4 2 BATTERY INSTALLATION......................................... 5 3 OPERATION................................................................... 6 3.1 Measuring Operation................................................ 6 3.2 Alarm Limit Settings.............................................. 11 3.3 Upload Data.............................................................14 3.4 Low Battery Indication..........................................15 4 ADDITIONAL ADVICE FOR OPERATION............16 5 TECHNICAL SPECIFICATIONS..............................17 6 ACCESSORIES.............................................................19 7 REPAIR AND MAINTENANCE ................................19 7.1 Maintenance............................................................19 7.2 Cleaning and Disinfecting Instruction..................20 8 TROUBLESHOOTING ...............................................21 9 APPENDIX ....................................................................22 Common Knowledge for SpO 2 Measurement............22 B Wristband Installation and Disassembly................25 User Manual for OW1.0 Wrist Oximeter -1- 1 Overview 1.1 Appearance Figure 1 Front View 1. LCD screen 2. Set key: shift display modes, confirm the operation etc. 3. Scroll key: move display cursor, modify parameter values etc. User Manual for OW1.0 Wrist Oximeter -2- Figure 2 Frontal Side View 4. Buzzer 5. Data interface 6. Wristband Underlay Figure 3 Right Side View 7. SpO 2 probe receptacle 1.2 Name and Model Name: Wrist Oximeter Model: OW1.0 User Manual for OW1.0 Wrist Oximeter -3- 1.3 Conformation It comprises the main unit and SpO 2 probe. 1.4 Features Wrist Oximeter can be used to monitor pulse oxygen saturation (SpO 2 ) and pulse rate accurately. Simply put your finger into sensor, SpO 2 value and pulse rate value will be displayed on screen and stored in the device. y It is lightweight, small in size and easy to carry; y Segment LCD display; y Automatic starts to measure SpO 2 and Pulse Rate(PR) and display pulse intensity bar graph as well; y Numerical value flash alarm function; y Data storage and transmission to PC for viewing and analysis; y Smart battery power managemen…

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Jan.4, 2011 Federal Communication Commission Authorization and Evaluation Division FCC ID: YTKPC-68A Re: Confidentiality Request Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, the applicant hereby requests confidential treatment of information applied this application as outlined below: 1: Block Diagram 2: Circuit Diagram 3: Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rules 0.457, disclosure of this Application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Boston Life Labs LLC. Contact person: Olivier de La Bastide Title: CTO Tel: +1617440427

PHOTOGRAPHS OF THE EUT TOP VIEW OF EUT BOTTOM VIEW OF EUT RIGHT VIEW OF EUT LEFT VIEW OF EUT

FCC ID Label Location

INTERNAL VIEW OF EUT-1 INTERNAL VIEW OF EUT-2 INTERNAL VIEW OF EUT-3 INTERNAL VIEW OF EUT-3

FCC Test Report Report No.: AGC10091010SZ01F1 FCC ID : YTKPC-68A PRODUCT DESIGNATION : Wrist Oximeter BRAND NAME : Boston Life Labs MODEL NAME : PC-68A CLIENT : Boston Life Labs LLC DATE OF ISSUE : Dec.23, 2010 STANDARD(S) : FCC Part 15 Rules Attestation of Global Compliance Co., Ltd. 1. CAUTION: This report shall not be reproduced except in full without the written permission of the test laboratory and shall not be quoted out of context. TABLE OF CONTENTS TABLE OF CONTENTS.................................................................................................................................................... 1 1. VERIFICATION OF COMPLIANCE............................................................................................................................ 2 2. PRODUCT INFORMATION.......................................................................................................................................... 3 3. TEST FACILITY.............................................................................................................................................................. 4 4. TEST EQUIPMENT LIST.............................................................................................................................................. 5 5. SUPPORT EQUIPMENT LIST..................................................................................................................................... 6 6. SYSTEM DESCRIPTION.............................................................................................................................................. 6 7. FCC RADIATED EMISSION TEST............................................................................................................................. 7 7.1 LIMITS OF RADIATED EMISSION TEST................................................................................................................ 7 7.2 BLOCK DIAGRAM OF RADIATED EMISSION TEST............................................................................................ 7 7.3 PRELIMINARY PROCEDURE OF RADIATED EMISSION TEST....................................................................... 7 7.4 FINAL PROCEDURE OF RADIATED EMISSION TEST....................................................................................... 8 7.5 TEST RESULT OF RADIATED EMISSION TEST.................................................................................................. 9 8 FCC LINE CONDUCTED EMISSION TEST............................................................................................................. 11 8.1 LIMITS OF LINE CONDUCTED EMISSION TEST............................................................................................... 11 8.2 BLOCK DIAGRAM OF LINE CONDUCTED EMISSION TEST........................................................................... 11 8.3 PRELIMINARY PROCEDURE OF LINE CONDUCTED EMISSION TEST...................................................... 12 8.4 FINAL PROCEDURE OF LINE CONDUCTED EMISSION TEST...................................................................... 12 8.5 TEST RESULT OF LINE CONDUCTED EMISSION TEST................................................................................. 13 APPENDIX 1...................................................................................................................................................................... 15 PHOTOGRAPHS OF TEST SETUP.............................................................................................................................. 15 APPENDIX 2...................................................................................................................................................................... 17 PHOTOGRAPHS OF EUT.............................................................................................................................................. 17 Report No.: AGC10091010SZ01F1 Page2of20 1. VERIFICATION OF COMPLIANCE Product Designation: Wrist Oximeter Brand Name: Boston Life Labs Model Name: PC-68A Applicant: Boston Life Labs LLC. Cambridge Innovation Center,One Broadway 14th, Cambridge,MA 02142,USA Manufacturer: Boston Life Labs LLC.(Shenzhen) 2017S,Building C,Tiley Plaza(II) ,Nanshan Central District,Shenzhen,518067, China. Type of Test: FCC Class B Measurement Procedure: ANSI C63.4: 2003 File Number: AGC10091010SZ01F1 Date of test: Dec.22 ,2010 Deviation: None Condition of Test Sample: Normal The above equipment was tested by Attestation of Global Compliance Co., Ltd. for compliance with the requirements set forth in the FCC Rules and Regulations Part 15, the measurement procedure according to ANSI C63.4:2003 This said equipment in the configuration described in this report shows the maximum emission levels emanating from equipment are within the compliance requirements. The test results of this report relate only to the tested sample identified in this report. Checked By: Forrest Lei Dec.23, 2010 Authorized By King Zhang Dec.23, 2010 Report No.: AGC10091010SZ01F1 Page3of20 2. PRODUCT INFORMATION Housing Type: Plastic EUT Rating Voltage: DC3V supply by battery Voltage During Test: DC3V I/O Ports of EUT I/O Port Type Q’TY Cable Tested with USB 1 N/A 1 Signal Port 1 0.2m,unshield 1 Report No.: AGC10091010SZ01F1 Page4of20 3. TEST FACILITY Facility Attestation of Global Compliance Co., Ltd. Location: 1F, No.2 Building, Huafeng No.1 Technical,Industrial Park, Sanwei, Xixiang, Baoan District,Shenzhen,China Description: The test site is constructed and calibrated to meet the FCC requirements in documents ANSI C63.4: 2003 Site Filing: The FCC Registration Number is 259865 The IC Number is 9083A Instrument Tolerance: All measuring equipment is in accord with ANSI C63.4 requirements that meet industry regulatory agency and accreditation agency requirement. Report No.: AGC10091010SZ01F1 Page5of20 4. TEST EQUIPMENT LIST Equipment used during the tests: Description Manufacturer Model…

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Report No.: AGC10091010SZ01F1 Page15of20 APPENDIX 1 PHOTOGRAPHS OF TEST SETUP TEST SETUP OF RADIATED EMISSION Report No.: AGC10091010SZ01F1 Page16of20 TEST SETUP OF CONDUCTED EMISSION