X44-PRONTO7Pronto 7 Spot Check Pulse CO-Oximeter

OPERATOR’S MANUAL Spot Check Pulse CO-Oximeter Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter i These operating instructions intend to provide the necessary information for proper operation of the Masimo Rainbow ® SET ® Pronto-7™ Pulse CO-Oximeter. General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of the Pronto-7 are prerequisites for proper use. Do not operate the Pronto-7 without completely reading and understanding these instructions. NOTICE: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, 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 further information contact: 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: ECREP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33 Covered by one or more of the following U.S. Patents: 5919134; 6002952; 6067462; 6229856; 6388240; 6463311; 6606511; 6643530; 6684090; 6699194; 6816741; 6961598; 6979812; 7003339; 7044918; 7186966; 7215984; 7215986; 7221971; 7254433; 7489958; 7496393; 7596398; international equivalents, or one or more of the patents referenced at www.masimo.com/ patents.htm. Other patents pending. Masimo, SET, , PVI, Signal Extraction Pulse CO-Oximeter, Rainbow and Signal IQ are registered trademarks of Masimo Corporation. Pronto-7, SIQ and SpHb are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. Printed in USA © 2010 Masimo Corporation. Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter ii NON-INVASIVE TOTAL HEMOGLOBIN (SpHb) ACCURACY COMPARED TO INVASIVE LABORATORY METHODS* In 3519 comparisons of non-invasive total hemoglobin (SpHb) and invasive hemoglobin (tHb) measurements from a laboratory CO-Oximeter, SpHb accuracy was as follows : 0.91 correlation ■ 0.8 g/dL standard deviation ■ Below 12 g/dL, 99% of SpHb readings were within 2 g/dL of the laboratory tHb value ■ At or above 12 g/dL, 99% of SpHb readings were within 2 g/dL of the laboratory value ■ * Masimo FDA Submission Data CONTRAINDICATIONS: The Pronto-7 is contraindicated for use as an apnea monitor. The Pronto-7 is also contraindicated for use as a continuous monitor. Safety Information, Warnings and Cautions The Pronto-7 is designed to minimize the possibility of hazards from errors in the sofware program by following sound engineering design processes, Risk Analysis and Software Validation. The Pronto-7 is to be operated by qualified personnel only. This manual, accessories, directions ■ for use, all precautionary information, and specifications should be read before use. Variation in hemoglobin measurements may be profound and may be affected by sample ■ type, body positioning, as well as other physiological conditions. As with most hemoglobin tests, Pronto-7 test results should be scrutinized in light of a specific patient’s condition. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data. Explosion hazard. Do not use the Pronto-7 in the presence of flammable anesthetics or other ■ flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. Electric shock hazard. Do not open the Pronto-7 instrument. Only a qualified operator may ■ perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment. High intensity extreme lights (including pulsating strobe lights) directed on the sensor, may not ■ allow the Pronto-7 to obtain readings. Check for possible EMI radiation interference such as, computer displays and/or LCD/plasma ■ TVs. The Pronto-7 should be considered an early warning device. For measurements of high or low ■ SpO2 and/or SpHb readings, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition. If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to ■ completely understand the patient’s condition. Pulse rate measurement is based on the optical detection of a peripheral flow pulse ■ and therefore may not detect certain arrhythmias. The Pronto-7 should not be used as a replacement or substitute for ECG based arrhythmia analysis. Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter iii Safety Information, Warnings and Cautions, continued As with all medical equipment, carefully route patient cabling to reduce the possibility of patient ■ entanglement or strangulation. Do not place the Pronto-7 or accessories in any position that might cause it to fall on the ■ patient. Do not lift the Pronto-7 by the cable or sensor. Patient Safety - If a sensor is damaged in any way, discontinue use immediately. ■ Always remove the sensor from the patient and completely disconnect the patient from the ■ Pronto-7 before bathing the patient. Interfering Substances: Dyes, or any substance containing dyes, that change usual blood ■ pigmentation may cause erroneous readings. Do not use the Pronto-7 or sensor during magnetic resonance imaging (MRI) scanning. ■ Induced current could potentially cause burns. The Pronto-7 may affect the MRI image and the MRI device may affect the accuracy of the Pulse CO-Oximetry parameters and measurements. Do not use the Pronto-7 during electrocautery. ■ Do not use the Pronto-7 or sensors during defibrillation. ■ If using the Pronto-7 during full body irradiation, keep the sensor out of the radiation field. If the ■ sensor is exposed to the radiation, the reading might be inaccurate or the instrument might read zero for the duration of the active irradiation period. Do not place the Pronto-7 where the controls can be cha…

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

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 copy or distribute 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 Telephone: 859-226-1000 Facsimile: 859-226-1040 www.intertek-etlsemko.com TEST REPORT Report Number: 3195108LEX-001 Project Number: 3195108 Evaluation of Model Number: Pronto-7 Pulse CO Oximeter FCCID: X44PRONTO7 IC ID: 7362C-PRONTO7 Tested to the SAR Criteria in FCC OET Bulletin 65, Supplement C (Edition 01-01) Industry Canada RSS-102 Issue 3 For Masimo Labs Test Performed by: Test Authorized by: Intertek 731 Enterprise Drive Lexington, KY 40510 Masimo Labs 30 Fairbanks Suite 100 Irvine, CA 92618 Prepared By:_______________________________Date:____1/17/2010________ Jason Centers, Senior Project Engineer Approved By:______________________________Date:____1/17/2010_________ Bryan Taylor, Team Leader – Engineering 731 Enterprise Drive, Lexington KY 40510 Evaluation For:Masimo Labs Model Number: Pronto-7X44PRONTO7 Report Number: 3195108LEX-001 Page 2 of 77 TABLE OF CONTENTS 1.0 DOCUMENT HISTORY ................................................................................................................ 4 2.0 REFERENCES................................................................................................................................. 5 3.0 INTRODUCTION............................................................................................................................ 6 MODIFICATIONS MADE TO TEST SAMPLE.................................................................................................. 6 4.0 TEST SITE DESCRIPTION........................................................................................................... 7 MEASUREMENT EQUIPMENT..................................................................................................................... 8 MEASUREMENT TRACEABILITY................................................................................................................ 8 MEASUREMENT UNCERTAINTY................................................................................................................ 9 5.0 JOB DESCRIPTION ..................................................................................................................... 10 6.0 SYSTEM VERIFICATION .......................................................................................................... 15 SYSTEM VALIDATION.............................................................................................................................. 15 TISSUE SIMULATING LIQUID DESCRIPTION AND VALIDATION............................................................... 16 7.0 EVALUATION PROCEDURES .................................................................................................. 18 TEST POSITIONS: ..................................................................................................................................... 18 REFERENCE POWER MEASUREMENT: .....................................................................................................18 COARSE SCAN: ........................................................................................................................................ 18 ZOOM SCAN: ........................................................................................................................................... 18 DATA EXTRAPOLATION: ......................................................................................................................... 19 REFERENCE POWER MEASUREMENT: .....................................................................................................19 RF AMBIENT ACTIVITY:.......................................................................................................................... 19 8.0 TEST CONFIGURATION............................................................................................................ 20 9.0 CRITERIA...................................................................................................................................... 24 10.0 TABULAR TEST RESULTS .................................................................................................... 25 CONDUCTED POWER MEASUREMENTS................................................................................................... 25 BODY MODE SAR TEST RESULTS........................................................................................................... 25 11.0 GRAPHICAL SAR SCAN RESULTS...................................................................................... 28 12.0 DIPOLE VALIDATION SCANS.............................................................................................. 51 13.0 PROBE CERTIFICATE............................................................................................................ 57 14.0 DIPOLE CERTIFICATE .......................................................................................................... 68 731 Enterprise Drive, Lexington KY 40510 Evaluation For:Masimo Labs Model Number: Pronto-7X44PRONTO7 Report Number: 3195108LEX-001 Page 3 of 77 15.0 PHANTOM CERTIFICATE ..................…

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

Cert. No. 1152.01 Electrical (EMC) APPLICANT: MOTOROLA INC FCC ID: IHDP6JF1 Test Report E83850.03 MOTOROLA INC. Page 1 of 131 FCC ACC M Ver 1.1 05Mayl 2000 DATE: 20 August 2008 I.T.L. (PRODUCT TESTING) LTD. FCC Radio Test Report for MOTOROLA INC. Equipment under test: W24 Wi-Fi Module W24 Written by: _____________________________ D. Shidlowsky, Documentation Approved by: _____________________________ A. Sharabi, Test Engineer Approved by: _____________________________ I. Raz, EMC Laboratory Manager This report must not be reproduced, except in full, without the written permission of I.T.L. (Product Testing) Ltd. This report relates only to items tested. Cert. No. 1152.01 Electrical (EMC) APPLICANT: MOTOROLA INC FCC ID: IHDP6JF1 Test Report E83850.03 MOTOROLA INC. Page 2 of 131 FCC ACC M Ver 1.1 05Mayl 2000 Measurement/Technical Report for MOTOROLA INC. W24 Wi-Fi Module W24 FCC ID: IHDP6JF1 20 August 2008 This report concerns: Original Grant x Class II change Class B verification Class A verification Class I change Equipment type: Direct Sequence Spread Spectrum Transmitter Request Issue of Grant: x Immediately upon completion of review Limits used: CISPR 22 Part 15 x Measurement procedure used is ANSI C63.4-2003. Application for Certification Applicant for this device: prepared by: (different from "prepared by") Ishaishou Raz Steve Gump ITL (Product Testing) Ltd. MOTOROLA Inc. Kfar Bin Nun 1301 E Algonquin D.N. Shimshon 99780 Schaumburg Illinois 60196-1078 Israel USA e-mail [email protected] Tel: +1-847-576-5000 e-mail: [email protected] APPLICANT: MOTOROLA INC FCC ID: IHDP6JF1 Test Report E83850.03 MOTOROLA INC. Page 3 of 131 FCC ACC M Ver 1.1 05Mayl 2000 TABLE OF CONTENTS 1. GENERAL INFORMATION ------------------------------------------------------------------------------- 5 1.1 Administrative Information.................................................................................5 1.2 List of Accreditations .........................................................................................6 1.3 Product Description ...........................................................................................7 1.4 Test Methodology..............................................................................................7 1.5 Test Facility .......................................................................................................7 1.6 Measurement Uncertainty .................................................................................7 2. SYSTEM TEST CONFIGURATION--------------------------------------------------------------------- 8 2.1 Justification........................................................................................................8 2.2 EUT Exercise Software .....................................................................................8 2.3 Special Accessories ..........................................................................................8 2.4 Equipment Modifications ...................................................................................8 2.5 Configuration of Tested System ........................................................................8 3. THEORY OF OPERATION ------------------------------------------------------------------------------10 4. SET UP PHOTOGRAPHS -------------------------------------------------------------------------------11 5. CONDUCTED EMISSION TEST DATA --------------------------------------------------------------13 5.1 Test Specification ............................................................................................13 5.2 Test Procedure................................................................................................13 5.3 Test Data .........................................................................................................14 5.4 Test Instrumentation Used, Conducted Measurement ...................................19 6. SPURIOUS RADIATED EMISSION BELOW 1 GHZ WITH ANTENNA ---------------------20 6.1 Test Specification ............................................................................................20 6.2 Test Procedure................................................................................................20 6.3 Test Data .........................................................................................................21 6.4 Test Instrumentation Used, Radiated Measurements ....................................22 6.5 Field Strength Calculation ...............................................................................23 7. SPURIOUS RADIATED EMISSION ABOVE 1 GHZ WITH ANTENNA ----------------------24 7.1 Radiated Emission Above 1 GHz....................................................................24 7.2 Test Data .........................................................................................................25 7.3 Test Instrumentation Used, Radiated Measurements Above 1 GHz ..............32 8. ANTENNA INFORMATION ------------------------------------------------------------------------------33 9. 26 DB BANDWIDTH 802.11 B/G SIGNALS--------------------------------------------------------35 9.1 Test procedure ................................................................................................35 9.2 Test Equipment Used......................................................................................42 10. MAXIMUM TRANSMITTED PEAK POWER OUTPUT 802.11 B/G SIGNALS -------------43 10.1 Test procedure ................................................................................................43 10.2 Results table....................................................................................................50 10.3 Test Equipment Used......................................................................................51 11. PEAK POWER OUTPUT OUT OF 2400-2483.5 MHZ BAND 802.11 B/G SIGNALS ----52 11.1 Test procedure ...............................................................................…

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

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)…

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