X44-PRONTO7APronto-7 Spot Check Pulse CO-Oximeter

DRAFT 02 17 14 Pronto-7 Operator's Manual www.masimo.com 1 Masimo Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter, also referred to as Pronto-7, operating instructions provide the necessary information for proper operation of Pronto-7. There may be information provided in this manual that is not relevant for your system. Do not operate Pronto-7 without completely reading and understanding the instructions in this manual. Notice: Purchase or possession of this instrument does not carry any express or implied license to use this instrument with replacement parts which would, alone or in combination with this instrument, fall within the scope of one of the relating patents. Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU Authorized Representative for Masimo Corporation: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany 3148433 Patents: www.masimo.com/patents.htm. Masimo, , Signal Extraction Pulse CO-Oximeter, rainbow, Pronto-7, SET, SpHb and Signal I.Q. are registered trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. Printed in U.S.A. www.masimo.com 2 Masimo © 2014 Masimo Corporation. www.masimo.com 3 Masimo Contents About this Manual -------------------------------------------------------------------------- 55 Product Description ----------------------------------------------------------------------- 77 Indications for Use --------------------------------------------------------------------- 77 Contraindications ----------------------------------------------------------------------- 77 Safety Information, Warnings, and Cautions---------------------------------------- 99 Safety Information, Warnings, and Cautions --------------------------------- 1010 Compliance Information, Warnings and Cautions --------------------------- 1213 Sensor Information, Warnings and Cautions --------------------------------- 1414 Chapter 1: Technology Overview --------------------------------------------------- 1515 Signal Extraction Technology (SET) -------------------------------------------- 1515 rainbow Pulse CO-Oximetry Technology -------------------------------------- 1515 Functional Oxygen Saturation ---------------------------------------------------- 1616 Pronto-7 vs. Drawn Whole Blood Measurements --------------------------- 1616 Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods* --------------------------------------------------------------- 1717 Chapter 2: Product Description------------------------------------------------------ 1919 Pronto-7 Description ---------------------------------------------------------------- 1919 Pronto-7 Front Panel and Touchscreen --------------------------------------- 2020 Pronto-7 Back Panel ---------------------------------------------------------------- 2222 Pronto-7 Bottom Panel ------------------------------------------------------------- 2323 Parameter and Measurement Descriptions ----------------------------------- 2323 Chapter 3: Setup ------------------------------------------------------------------------ 2525 Unpacking and Inspection the System ----------------------------------------- 2525 Preparation for Use ----------------------------------------------------------------- 2525 Chapter 4: Operation ------------------------------------------------------------------- 2727 Common Screens ------------------------------------------------------------------- 2828 Commonly Used Icons ------------------------------------------------------------- 2828 Recommended Initial Testing Procedure -------------------------------------- 3030 Pronto-7Pronto-7 Contents www.masimo.com 4 Masimo Patient Testing ----------------------------------------------------------------------- 3332 Completed Test ---------------------------------------------------------------------- 3534 Incomplete Test ---------------------------------------------------------------------- 3634 Key Features ------------------------------------------------------------------------- 3635 Main Menu Options ----------------------------------------------------------------- 5147 Battery ---------------------------------------------------------------------------------- 5854 Chapter 5: Alarms and Messages -------------------------------------------------- 6157 Messages------------------------------------------------------------------------------ 6157 Chapter 6: Troubleshooting ---------------------------------------------------------- 6359 Troubleshooting ---------------------------------------------------------------------- 6359 Chapter 7: Specifications ------------------------------------------------------------- 6561 Specifications ------------------------------------------------------------------------- 6561 Calibration Verification ------------------------------------------------------------- 6864 Symbols -------------------------------------------------------------------------------- 6864 Chapter 8: Service and Repair ------------------------------------------------------ 7167 Service and Repair ------------------------------------------------------------------ 7167 Index --------------------------------------------------------------------------------------- 7973 www.masimo.com 5 Masimo About this Manual This manual explains how to set up and use Pronto-7. Important safety information relating to general use of the product appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions and notes. A warning is given when actions may result in a serious outcome (for example, injury, serious adverse…

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Connect One Ltd. FCC ID: XM5-SM2144N1, IC: 8516A-SM2144N1 Report Number: R0907162-247 Page 46 of 46 FCC Part 15.247 & IC RSS-210 Test Report 15.6 EUT Top View without shielding 15.7 EUT Bottom View ***** END OF REPORT *****

731 Enterprise Drive Lexington, KY 40510 Telephone: 859-226-1000 Facsimile: 859-226-1040 www.intertek-etlsemko.com TEST REPORT Report Number: 100724301LEX-002 Project Number: G100724301 Evaluation of Model Number: PRONTO7A FCCID: X44PRONTO7A ICID: 7362A-PRONTO7A Tested to the SAR Criteria in FCC Part §2.1093 Industry Canada RSS-102 Issue 4 For Cercacor Laboratories, Inc. Test Performed by: Test Authorized by: Intertek 731 Enterprise Drive Lexington, KY 40510 Cercacor Laboratories, Inc. 30 Fairbanks Ste 100 Irvine, CA 92618 Prepared By:_______________________________Date:____10/31/2013________ Jason Centers, Senior Project Engineer Approved By:______________________________Date:____10/31/2013_________ James Sudduth, Senior Staff Engineer This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. 731 Enterprise Drive, Lexington KY 40510 Evaluation For:Cercacor Laboratories, Inc. Model Number: PRONTO7AX44PRONTO7A Report Number: 100724301LEX-002 TABLE OF CONTENTS 1.0 DOCUMENT HISTORY ................................................................................................................ 3 2.0 INTRODUCTION ............................................................................................................................ 4 MODIFICATIONS MADE TO TEST SAMPLE .................................................................................................. 4 3.0 TEST SITE DESCRIPTION ........................................................................................................... 5 MEASUREMENT EQUIPMENT ..................................................................................................................... 6 MEASUREMENT TRACEABILITY ................................................................................................................ 6 MEASUREMENT UNCERTAINTY ................................................................................................................ 7 4.0 JOB DESCRIPTION ....................................................................................................................... 9 5.0 SYSTEM VERIFICATION .......................................................................................................... 14 SYSTEM VALIDATION.............................................................................................................................. 14 TISSUE SIMULATING LIQUID DESCRIPTION AND VALIDATION ............................................................... 15 6.0 EVALUATION PROCEDURES .................................................................................................. 16 TEST POSITIONS: ..................................................................................................................................... 16 REFERENCE POWER MEASUREMENT: ..................................................................................................... 16 AREA SCAN: ............................................................................................................................................ 16 ZOOM SCAN: ........................................................................................................................................... 16 INTERPOLATION, EXTRAPOLATION AND DETECTION OF MAXIMA: ........................................................ 17 POWER DRIFT MEASUREMENT: .............................................................................................................. 18 RF AMBIENT ACTIVITY:.......................................................................................................................... 18 7.0 TEST CONFIGURATION ............................................................................................................ 19 8.0 CRITERIA ...................................................................................................................................... 20 9.0 TABULAR TEST RESULTS ........................................................................................................ 21 CONDUCTED POWER MEASUREMENTS ................................................................................................... 21 BODY MODE SAR TEST RESULTS ........................................................................................................... 22 SIMULTANEOUS TRANSMISSION TEST RESULTS ..................................................................................... 22 10.0 REFERENCES ........................................................................................................................... 23 11.0 APPENDIX A – SAR PLOTS ................................................................................................... 24 12.0 APPENDIX B – SYSTEM VERIFICATION PLOTS ............................................................ 28 Page 2 of 29 731 Enterprise Drive, Lexington KY 40510 Evaluation For:Cercacor Laboratories, Inc. Model Number: PRONTO7AX44PRONTO7A Report Number: 100724301LEX-002 1.0 DOCUMENT HISTORY Revision/ Project Number Writer Initials Date Change 1.0 /G100724301 JC 10/31/2013 Original document Page 3 of 29 731 Enterprise Drive, Lexington KY 40510 E…

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APPENDIX A – Phantom Certificate

FCC CFR47 PART 15 SUBPART C CLASS II PERMISSIVE CHANGE CERTIFICATION TEST REPORT FOR BLUETOOTH SERIAL PORT MODULE MODEL NUMBER: LMX9838SB FCC ID: ED9LMX9838 REPORT NUMBER: 07U11080-1 ISSUE DATE: AUGUST 31, 2007 Prepared for NATIONAL SEMICONDUCTOR 2900 SEMICONDUCTOR DR. SANTA CLARA, CA 95052, USA Prepared by COMPLIANCE CERTIFICATION SERVICES 47173 BENICIA STREET FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 2 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of CCS. Revision History Rev. Issue Date Revisions Revised By --- 08/31/07 Initial Issue T. Chan REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 3 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of CCS. TABLE OF CONTENTS 1. ATTESTATION OF TEST RESULTS............................................................................................. 4 2. TEST METHODOLOGY .................................................................................................................. 5 3. FACILITIES AND ACCREDITATION .......................................................................................... 5 4. CALIBRATION AND UNCERTAINTY.......................................................................................... 5 4.1. MEASURING INSTRUMENT CALIBRATION ............................................................................. 5 4.2. MEASUREMENT UNCERTAINTY ............................................................................................... 5 5. EQUIPMENT UNDER TEST............................................................................................................6 5.1. DESCRIPTION OF EUT ..............................................................................................................6 5.2. CLASS II PERMISSIVE CHANGE DESCRIPTION ..................................................................... 6 5.3. MAXIMUM OUTPUT POWER .................................................................................................... 6 5.4. DESCRIPTION OF AVAILABLE ANTENNAS ............................................................................. 6 5.5. SOFTWARE AND FIRMWARE .................................................................................................... 6 5.6. WORST-CASE CONFIGURATION AND MODE......................................................................... 6 5.7. DESCRIPTION OF TEST SETUP ................................................................................................ 7 6. TEST AND MEASUREMENT EQUIPMENT ................................................................................ 9 7. LIMITS AND RESULTS ................................................................................................................. 10 7.1. AVERAGE POWER..................................................................................................................... 10 7.2. RADIATED EMISSIONS.............................................................................................................11 7.2.1. TRANSMITTER RADIATED SPURIOUS EMISSIONS ................................................. 11 7.2.2. TRANSMITTER RADIATED EMISSIONS ABOVE 1 GHZ .......................................... 14 7.2.3. WORST-CASE RADIATED EMISSIONS BELOW 1 GHz ............................................. 23 7.3. POWERLINE CONDUCTED EMISSIONS ................................................................................ 25 8. SETUP PHOTOS .............................................................................................................................. 29 REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 4 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of CCS. 1. ATTESTATION OF TEST RESULTS COMPANY NAME: NATIONAL SEMICONDUCTOR 2900 SEMICONDUCTOR DR. SANTA CLARA, CA 95052, USA EUT DESCRIPTION: BLUETOOTH SERIAL PORT MODULE MODEL: LMX9838SB SERIAL NUMBER: QS0714303 DATE TESTED: AUGUST 21-22, 2007 APPLICABLE STANDARDS STANDARD TEST RESULTS FCC PART 15 SUBPART C NO NON-COMPLIANCE NOTED Compliance Certification Services, Inc. tested the above equipment in accordance with the requirements set forth in the above standards. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. Note: The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. This document may not be altered or revised in any way unless done so by Compliance Certification Services and all revisions are duly noted in the revisions section. Any alteration of this document not carried out by Compliance Certification Services will constitute fraud and shall nullify the document. No part of this report may be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any government agency. Approved & Released For CCS By: Tested By: THU CHAN THANH NGUYEN EMC SUPERVISOR EMC ENGINEER COMPLIANCE CERTIFICATION SERVICES COMPLIANCE CERTIFICATION SERVICES REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 5 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510)…

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Note: This test report is for the customer shown above and their specific product only. It may not be duplicated or used in part without prior written consent from Bay Area Compliance Laboratories Corp. This report must not be used by the customer to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government . FCC PART 15.247 INDUSTRY CANADA RSS-210, ISSUE 7, JUNE 2007 MEASUREMENT AND TEST REPORT For Wi2Wi, Inc. 2107 N. First Street, Ste. 540 San Jose, CA 95131, USA FCC ID: U9R-W2SW0001 IC ID: 7089A-W2SW0001 Model: W2SW0001 Report Type: Original Report Product Type: 802.11b/g Module Test Engineer(s): James Ma Report Number: R0708036 Report Date: 2007-09-26 Reviewed By: RF Engineering Lead: Daniel Deng Prepared By: (J8) Bay Area Compliance Laboratories Corp. (BACL) 1274 Anvilwood Ave. Sunnyvale, CA 94089, USA Tel: (408) 732-9162 Fax: (408) 732-9164 Wi2Wi, Inc. FCC ID: U9R-W2SW0001, IC: 7089A-W2SW0001 Report No.: R0708036 Page 2 of 62 FCC Part 15.247 and IC RSS-210 TABLE OF CONTENTS 1 GENERAL INFORMATION .......................................................................................................................................4 1.1 PRODUCT DESCRIPTION FOR EQUIPMENT UNDER TEST (EUT) ............................................................................. 4 1.2 MECHANICAL DESCRIPTION OF EUT ................................................................................................................... 4 1.3 ANTENNA DESCRIPTION....................................................................................................................................... 4 1.4 EUT PHOTOGRAPH.............................................................................................................................................. 5 1.5 OBJECTIVE........................................................................................................................................................... 5 1.6 RELATED SUBMITTAL(S)/GRANT(S)..................................................................................................................... 5 1.7 TEST METHODOLOGY.......................................................................................................................................... 5 1.8 MEASUREMENT UNCERTAINTY............................................................................................................................ 6 1.9 TEST FACILITY..................................................................................................................................................... 6 2 SYSTEM TEST CONFIGURATION ..........................................................................................................................7 2.1 JUSTIFICATION..................................................................................................................................................... 7 2.2 EUT EXERCISE SOFTWARE.................................................................................................................................. 7 2.3 SPECIAL ACCESSORIES......................................................................................................................................... 7 2.4 EQUIPMENT MODIFICATIONS...............................................................................................................................7 2.5 LOCAL SUPPORT EQUIPMENT LIST AND DETAILS................................................................................................ 7 2.6 TEST SETUP BLOCK DIAGRAMS........................................................................................................................... 8 3 SUMMARY OF TEST RESULTS ...............................................................................................................................9 4 FCC §15.203, IC RSS-Gen §7.1.4 – ANTENNA REQUIREMENT ..........................................................................10 4.1 APPLICABLE STANDARD.................................................................................................................................... 10 4.2 RESULT.............................................................................................................................................................. 10 5 FCC §15.207, IC RSS-Gen §7.2.2 - CONDUCTED EMISSIONS .............................................................................11 5.1 SECTION 15.207 & RSS-GEN 7.2.2 CONDUCTED LIMITS:................................................................................... 11 5.2 TEST SETUP....................................................................................................................................................... 11 5.3 TEST EQUIPMENT LIST AND DETAILS................................................................................................................. 11 5.4 TEST PROCEDURE.............................................................................................................................................. 12 5.5 ENVIRONMENTAL CONDITIONS.......................................................................................................................... 12 5.6 SUMMARY OF TEST RESULTS............................................................................................................................. 12 6 FCC §2.1051 & §15.247(d), RSS-210 § A8.5 & RSS-Gen 7.2 - SPURIOUS EMISSIONS AT ANTENNA TERMINALS ..........................................................................................................................................................................15 6.1 APPLICABLE STANDARD.................................................................................................................................... 15 6.2 MEASUREMENT PROCEDURE.............................................................................................................................. 15 6.3 EQ…

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REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 29 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of CCS. 8. SETUP PHOTOS RADIATED RF MEASUREMENT SETUP RADIATED X POSITION REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 30 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of CCS. Y-POSITION PHOTO REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 31 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of CCS. Z-POSITION PHOTO REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 32 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of CCS. POWERLINE CONDUCTED EMISSIONS MEASUREMENT SETUP EUT LINE CONDUCTED FRONT PHOTO REPORT NO: 07U11080-1 DATE: AUGUST 31, 2007 EUT: BLUETOOTH SERIAL PORT MODULE FCC ID: ED9LMX9838 Page 33 of 33 COMPLIANCE CERTIFICATION SERVICES DOCUMENT NO: CCSUP4031A 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 771-1000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of CCS. END OF REPORT EUT LINE CONDUCTED BACK PHOTO

Wi2Wi, Inc. FCC ID: U9R-W2SW0001, IC: 7089A-W2SW0001 Report No.: R0708036 Page 67 of 72 FCC Part 15.247 and IC RSS-210 14 EXHIBIT B - TEST SETUP PHOTOGRAPHS 14.1 Conducted Emissions –Front View 14.2 Conducted Emissions – Side View Wi2Wi, Inc. FCC ID: U9R-W2SW0001, IC: 7089A-W2SW0001 Report No.: R0708036 Page 68 of 72 FCC Part 15.247 and IC RSS-210 14.3 Receiver Radiated Emissions – Front View 14.4 Receiver Radiated Emissions – Rear View Wi2Wi, Inc. FCC ID: U9R-W2SW0001, IC: 7089A-W2SW0001 Report No.: R0708036 Page 69 of 72 FCC Part 15.247 and IC RSS-210 14.5 Transmitter Radiated Spurious Emissions – Front View 14.6 Transmitter Radiated Spurious Emissions – Rear View