VKF-RAD7CPLRadical 7R

Operator’s Manual Wireless Radio Addendum Pulse CO-Oximeter 2 Radical-7 Operator’s Manual Wireless Radio Addendum This addendum describes wireless radio licensing and specification information for the Radical-7 Pulse CO-Oximeter. This addendum is used in conjunction with the Radical-7 Operator’s Manual, part number 33975. PAGE i Wireless Radio FCC ID: VKF-RAD7CPL IC: 7362A-RAD7CPL Bluetooth FCC ID: PVH0925 IC: 5325A-0925 SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES ■ Do not place the Pulse CO-Oximeter or accessories in any position that might cause it to fall on the patient. Pulse CO-Oximeter must be placed greater than 20cm from the patient’s head or torso. ■ This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2, Medical Device Directive 93/42/EEC and Part 15, FCC Rules/USA. ■ This device complies with part 15 of the FCC Rules. Operation is subject to the fol- lowing two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. ■ The Bluetooth component in this device has been qualified according to the Blue- tooth specification 2.1+EDR ■ This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ■ Reorient or relocate the receiving device. ■ Increase the separation between the equipment. ■ Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. ■ Consult the manufacturer for help. ■ In order to connect wirelessly to a compatible interface system like Patient SafetyNet, the Radical-7 should be placed in an environment free from RF shielding, which could hinder wireless reception. ■ To minimize radio interference, other electrical equipment that emits RF transmissions should not be in close proximity to the Radical-7 1 3 ■ Changes or modifications to the wireless radio feature whether intentional or unintentional are prohibited without written approval from Masimo Corporation. SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ The Radical-7 (device with optional radio) wirelessly transmits real-time sensor connectivity status, indicating a connect and/or disconnect state. If the device is in a failure mode then the radio power is disabled and an error message is indicated on the device display. The device does not have a powered state where no information is transmitted. ■ In accordance with FCC requirements, the Radical-7 (device with optional radio) must be placed greater then 20 cm from the patient’s head or torso. ■ In accordance with FCC requirements, radio accessories on the Radical-7 (device with optional radio) cannot be attached directly to the patient using any accessory containing metal components. ■ In accordance with international telecommunication requirements, the frequency band of 5,150 MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. SECTION 7: SPECIFICATIONS Wireless Radio Specifications (if installed) Radio Modes 8802.11 a/b/g Encryption64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES Authentication Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP, TTLS, TLS, EAP-FAST Compliance USA FCC ID: VKF-RAD7CPL FCC parts 15.207, 15.209, 15.247 and 15.407 Canada IC: 7362A-RAD7CPL RSS-210 Europe EN 300 328 EN 301 893 EN 301 489-17 Bluetooth Specifications (if installed) RF output power (conducted - excluding antenna gain) Class 2 , max 4dBm (2.5mW) Output frequency2.402 - 2.480 GHz, ISM band Referenced QDIDsB016013 combined with B015102 ModulationFHSS (Frequency hopping) Compliance USAFCC ID: PVH0925 CanadaIC: 5325A-0925 Europe EN 300 328 EN 301 489-1 EN 301 489-17 EN 61000-6-2 34168/6394A - 0510 Masimo Corporation 40 Parker Irvine, CA 92618 USA www.masimo.com Manufacturer: © 2008 Masimo Corporation. EU Authorized Representative for Masimo Corporation: EC REP MDSS GmbH Schiffgraben 41 30175 Hannover, Germany

Pulse CO- Oximeter with Rainbow Technology OPERATOR’S MANUAL Radical-7R Pulse CO-Oximeter Operator’s Manual i The Radical-7R Pulse CO-Oximeter Operating Instructions provide the necessary information for proper operation of all models of the Radical-7R Pulse CO-Oximetry system. There may be information provided in this manual that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of the Radical-7R Pulse CO-Oximeter are prerequisites for its proper use.Do not operate the Radical-7R Pulse CO-Oximeter 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 patents relating to this instrument.CAUTION: Federal law (U.S.) restricts this instrument to sale by or on the order of a physician.Masimo Corporation40 ParkerIrvine, CA 92618USATel.: 949-297-7000Fax.: 949-297-7001www.masimo.comCovered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215,986, 7,215,984, 7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194, 6,684,090, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525, 6,388,240, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo.com/patents.htm. Products containing SatShare ® feature are also covered by U.S. Patent 6,770,028. Other patents pending. © 2009 Masimo Corporation, Masimo, , RadNet, Rainbow, SpCO, SpMet, SpHb, Discrete Saturation Transform, DST, DCI, FastSat, SatShare, PVI, SET, Signal IQ, LNOP and LNCS are federally registered trademarks of Masimo Corporation. Radical-7R, Patient SafetyNet, Radical Screen, LNOPv, APOD, SpOC, SpHct, Pulse CO-Oximeter, Pleth Variability Index and RRa are trademarks of Masimo Corporation. Radical-7R Pulse CO-Oximeter Operator’s Manual NON-INVASIVE TOTAL HEMOGLOBIN (SpHb) ACCURACY COMPARED TO INVASIVE LABORATORY METHODS*In 492 comparisons of non-invasive total hemoglobin (SpHb) and invasive hemoglobin (tHb)measurements from a laboratory CO-Oximeter, SpHb accuracy was as follows:■ 0.90 correlation ■ 0.95 g/dL standard deviation ■ Below 12 g/dL, 99% of SpHb readings were < 2 g/dL of the laboratory tHb value ■ At or above 12 g/dL, 94% of SpHb readings were < 2 g/dL of the laboratory value * Masimo FDA Submission DataSAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTESThe Radical-7R Signal Extraction Pulse CO-Oximeter is designed to minimize the possibility of hazards from errors in the software program by following sound engineering design processes, Risk Analysis and Software Validation.■ 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, Radical-7R 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 Pulse CO-Oximeter in the presence of fl ammable anesthetics or other fl ammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. ■ High intensity, extreme lights (including pulsating strobe lights) directed on the sensor may not allow the Pulse CO-Oximeter to obtain readings. ■ Excessive ambient noise may affect the accuracy of the respiration rate reading from the Acoustic Respiration Sensor. ■ When monitoring Acoustic Respiration, Masimo recommends minimally monitoring both oxygenation (SpO2) and respiration (RRa). ■ The Pulse CO-Oximeter is NOT intended for use as an apnea monitor. ■ Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The Pulse CO-Oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis. ■ The Pulse CO-Oximeter should be considered an early warning instrument. As a trend towards patient hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition. ■ The Pulse CO-Oximeter is to be operated by qualifi ed personnel only. This manual, accessory Directions for Use (DFU), all precautionary information, and specifi cations should be read before use. ■ Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to replace the battery of the Handheld instrument. Only a qualifi ed operator may perform maintenance procedures specifi cally described in this manual. Refer servicing to Masimo for repair of this equipment. ■ Ensure that the HF surgical neutral electrode is properly connected to help prevent unin-tended current return paths when using high frequency (HF) surgical equipment. ■ As with all medical equipment, carefully route patient cabling to reduce the ii Radical-7R Pulse CO-Oximeter Operator’s Manual possibility of patient entanglement or strangulation. ■ Use cables only from the instrument manufacturer to provide protection against the effects of discharge from a cardiac defibrillator and burns. ■ Do not place the Pulse CO-Oximeter or accessories in any position that might cause it to fall on the patient. Do not lift the Pulse CO-Oximeter by the power cord or any other cable. ■ Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. ■ SpO 2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (M…

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Northwest EMC TCB Compliance Opinion Rev. 12/08/09 MASI0057 Information about the Applicant Grantee (Company Name) Masimo Corporation FCC Contact Person Eugene Kim Address 40 Parker City, State, Zip Irvine, CA 92618 Job Number MASI0057 Model Radical 7 FCC ID VKF-RAD7CPL Agent David Mosley Approval Type Original Equipment Class DTS Digital Transmission System UNI Unlicensed National Information Infrastructure Rule Part 15.247, 15.407 Overview This application is for the certification of Masimo Corporation’s model Radical 7 CO-Oximeter , FCC ID: VKF-RAD7CPL, which contains an 802.11 a/b/g radio used for wireless transmission of data to a patient monitoring network. The radio operates in the 2.4 and 5.8 GHz bands as a DTS device and in the 5.2 GHz band as a UNII device. The device contains a previously certified Bluetooth radio, FCC ID:PVH0925. Co-located MPE estimates have been submitted showing compliance with RF Exposure requirements. Please note the cover letter and “Model Name Explanation.pdf” for a discussion of the various test reports. Confidentiality requested for allowed files. Request is properly addressed and referenced. No short term confidentiality requested. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature 6/24/2010 Dave Tolman, TCB Committee

Bointec Taiwan Corporation Limited General Office: 9F-7,800,Sec 5, Chunghsiao E. Rd., Taipei, Taiwan. ZIP:11082 Warehouse : 1F,#3, Alley20,Lane790,Sec 5, Chunghsiao E. Rd., Taipei, Taiwan. ZIP:11082 TEL:+886-2-2759-0081 FAX:+886-2-2759-1659 WEB:www.bointec.com September 11, 2008 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To whom it may concern, We Bointec Taiwan Corporation Limited hereby respectfully request that under the provision of 47 CFR 0.459, the documents listed below and attached with this application for certification be provided with confidential status. • Schematics- SX-SDWAG • Theory of Operation- SX-SDWAG • Frequency Block Diagrams- SX-SDWAG Any exhibit / information for which we have requested confidentiality, but which may not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by us. Substantial competitive harm to us could result should they be made available to the public. Sincerely, Howard Juang Project Manager Bointec Taiwan Corporation Limited 9F-7, 800, Sec.5, Chunghsiao E. Rd., Taipei, Taiwan ZIP:11082 TEL: +886-2-759-0081 ext.229

Title: Label, Radical 7, FCC, Non-UL, Non-CE, Certifications LAB-6395 Revision: A DRO-28078 05/10

Innovative Technology for a Connected World Black Chip Internal Surface Mount Antenna global solutions: local support TM Americas: +1.847 839.6907 [email protected] Europe: +1.32.80.7866.12 [email protected] Asia: +1.65.6.243.8022 [email protected] www.lairdtech.com Features • Small and lightweight • Wide bandwidth, ultra-wide band capable • Available in tape and reel packaging • SMT compatible including lead free processes • Conformance to European RoHS directive 2002/95/EC The evolution of technology has brought the need to communicate everywhere and at all times without being confined to one space. Laird Technologies’ internal wireless device antennas feature wide bandwidth to enhance the performance and application of portable wireless devices based on standards such as 802.11 and Bluetooth ® . The antennas are specifically designed to be embedded inside devices for aesthetically pleasing integration with high durability. Innovative Technology for a Connected World Black Chip Internal Surface Mount Antenna ANT-DS-BlAck-chip 0809 Any information furnished by laird Technologies, inc. and its agents is believed to be accurate and reliable. All specifications are subject to change without notice. Responsibility for the use and application of laird Technologies materials rests with the end user, since laird Technologies and its agents cannot be aware of all potential uses. laird Technologies makes no warranties as to the fitness, merchantability or suitability of any laird Technologies materials or products for any specific or general uses. laird Technologies shall not be liable for incidental or consequential damages of any kind. All laird Technologies products are sold pursuant to the laird Technologies’ Terms and conditions of sale in effect from time to time, a copy of which will be furnished upon request. © copyright 2009 laird Technologies, inc. All Rights Reserved. laird, laird Technologies, the laird Technologies logo, and other marks are trade marks or registered trade marks of laird Technologies, inc. or an affiliate company thereof. Other product or service names may be the property of third parties. Nothing herein provides a license under any laird Technologies or any third party intellectual property rights. ModEL NuMBER PART NuMBERdESCRiPTioNCoNNECToR Wic2452-A MAF95029 Tape and reel N/A Wic2452-A-SM MAF95032Ultrawide-band on eval board SMA-female edgemount SPECifiCATioNS Frequency range 2.4 – 2.5 Ghz 4.9 – 6.0 Ghz peak gain > 2 dBi > 3 dBi polarization linear Nominal impedance 50 ohms SWR (min. performance) <2.0:1 Temperature range -40° to +85°c Vibration6G RMS (9.04g2/hz) for 15 minutes each in vertical and horizontal. No appearance or functional change Thermal shock Four repeated cycles of 1 hr. at +85°c and 1 hr. at -40°c. No appearance or functional change. Radiating element size 8 x 6 x 2.5 mm (l x W x h) physical mass 0.21 grams length w/ solder tabs 12mm

Masimo Corporation Rad 7C+ Report No. MASI0057.1 Report Prepared By www.nwemc.com 1-888-EMI-CERT © 2010 Northwest EMC, Inc 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Test Last Date of Test: May , 2010 Masimo Corporation Model: Rad 7C+ Emissions Test Description Specification Test Method Pass/Fail Maximum Permissible Exposure FCC 2.1091:2009 OET Bulletin 65, Supplement C Ed 01-01 Pass Modifications made to the product See the Modifications section of this report Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 41 Tesla Ave. Irvine, CA 92618 Phone: (503) 844-4066 Fax: 844-3826 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834B-2). Approved By: Don Facteau, IS Manager NVLAP Lab Code: 200676-0 This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Northwest EMC Revision History Revision 05/05/03 Revision Number Description Date Page Number 00 None Accreditations and Authorizations FCC Accredited by NVLAP for performance of FCC radio, digital, and ISM device testing. Our Open Area Test Sites, certification chambers, and conducted measurement facilities have been fully described in reports filed with the FCC and accepted by the FCC in letters maintained in our files. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by the FCC as a Telecommunications Certification Body (TCB). This allows Northwest EMC to certify transmitters to FCC specifications in accordance with 47 CFR 2.960 and 2.962. NVLAP Northwest EMC, Inc. is accredited under the United States Department of Commerce, National Institute of Standards and Technology, and National Voluntary Laboratory Accreditation Program for satisfactory compliance with the requirements of ISO/IEC 17025 for Testing Laboratories. The NVLAP accreditation encompasses Electromagnetic Compatibility Testing in accordance with the European Union EMC Directive 2004/108/EC, and ANSI C63.4. Additionally, Northwest EMC is accredited by NVLAP to perform radio testing in accordance with the European Union R&TTE Directive 1999/5/EEC, the requirements of FCC, and the RSS radio standards for Industry Canada. NVLAP LAB CODE 200629-0 NVLAP LAB CODE 200630-0 NVLAP LAB CODE 200676-0 NVLAP LAB CODE 200761-0 NVLAP LAB CODE 200881-0 Industry Canada Accredited by NVLAP for performance of Industry Canada RSS and ICES testing. Our Open Area Test Sites and certification chambers comply with RSS-Gen, Issue 2 and have been filed with Industry Canada and accepted. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by NIST and recognized by Industry Canada as a Certification Body (CB) per the APEC Mutual Recognition Arrangement (MRA). This allows Northwest EMC to certify transmitters to Industry Canada technical requirements. (Site Filing Numbers - Hillsboro: 2834D-1, 2834D-2, Sultan: 2834C-1, Irvine: 2834B-1, 2834B-2, Brooklyn Park: 2834E-1) CAB Designated by NIST and validated by the European Commission as a Conformity Assessment Body (CAB) to conduct tests and approve products to the EMC directive and transmitters to the R&TTE directive, as described in the U.S. - EU Mutual Recognition Agreement. NEMKO Assessed and accredited by NEMKO (Norwegian testing and certification body) for European emissions and immunity testing. As a result of NEMKO's laboratory assessment, they will accept test results from Northwest EMC, Inc. for product certification (Authorization No. ELA 119). Accreditations and Authorizations Australia/New Zealand The National Association of Testing Authorities (NATA), Australia has been appointed by the ACA as an accreditation body to accredit test laboratories and competent bodies for EMC standards. Accredited test reports or assessments by competent bodies must carry the NATA logo. Test reports made by an overseas laboratory that has been accredited for the relevant standards by an overseas accreditation body that has a Mutual Recognition Agreement (MRA) with NATA are also accepted as technical grounds for product conformity. The report should be endorsed with the respective logo of the accreditation body (NVLAP). VCCI Accepted as an Associate Member to the VCCI, Acceptance No. 564. Conducted and radiated measurement facilities have been registered in accordance with Regulations for Voluntary Control Measures, Article 8. (Registration Numbers. - Hillsboro: C-1071, R-1025, G-84, C-2687, T-1658, and R-2318, Irvine: R-1943, G-85, C- 2766, and T-1659, Sultan: R-871, G-83, C-1784, and T-1511, Brooklyn Park: R-3125, G-86, G-141, C-3464, and T-1634). BSMI Northwest EMC has been designated by NIST and validated by C-Taipei (BSMI) as a CAB to conduct tests as described in the APEC Mutual Recognition Agreement (US0017). License No.SL2-IN-E-1017. GOST Northwest EMC, Inc. has been assessed and accredited by the Russian Certification bodies Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC, to perform EMC and Hygienic testing for Information Technology Products. As a result of their laboratory assessment, they will accept test results from Northwest EMC, Inc. for product certification KCC Northwest EMC, Inc is a CAB designated by MRA partners and recognized by Korea. (Assigned Lab Numbers: Hillsboro: US0017, Irvine: US0158, Sul…

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Masimo Rad-87 Report No. MASI0009 Rev 01 Report Prepared By www.nwemc.com 1-888-EMI-CERT © 2008Northwest EMC, Inc 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Test Last Date of Testing: September 17, 2008 Masimo Model: Rad-87 Emissions Test Description Specification Test Method Pass/Fail Spurious Radiated Emissions FCC 15.247 (DTS):2007 ANSI C63.4:2003 KDB No. 558074 Pass Spurious Conducted Emissions FCC 15.247 (DTS):2007 ANSI C63.4:2003 KDB No. 558074 Pass Band Edge Compliance FCC 15.247 (DTS):2007 ANSI C63.4:2003 KDB No. 558074 Pass Power Spectral Density FCC 15.247 (DTS):2007 ANSI C63.4:2003 KDB No. 558074 Pass Output Power FCC 15.247 (DTS):2007 ANSI C63.4:2003 KDB No. 558074 Pass Occupied Bandwidth FCC 15.247 (DTS):2007 ANSI C63.4:2003 KDB No. 558074 Pass AC Powerline Conducted Emissions FCC 15.207:2007 ANSI C63.4:2003 Pass Modifications made to the product See the Modifications section of this report Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 41 Tesla Ave. Irvine, CA 92618 Phone: (503) 844-4066 Fax: 844-3826 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada(Site filing #2834B-2). Approved By: Don Facteau, IS Manager NVLAP Lab Code: 200676-0 This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Northwest EMC Revision History Revision 05/05/03 Revision Number Description Date Page Number 01 Corrected cable information 9/24/08 12 Northwest EMC Accreditations and Authorizations Revision 03/18/05 FCC: Accredited by NVLAP for performance of FCC radio, digital, and ISM device testing. Our Open Area Test Sites, certification chambers, and conducted measurement facilities have been fully described in reports filed with the FCC and accepted by the FCC in letters maintained in our files. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by the FCC as a Telecommunications Certification Body (TCB). This allows Northwest EMC to certify transmitters to FCC specifications in accordance with 47 CFR 2.960 and 2.962. NVLAP: Northwest EMC, Inc. is accredited under the United States Department of Commerce, National Institute of Standards and Technology, and National Voluntary Laboratory Accreditation Program for satisfactory compliance with the requirements of ISO/IEC 17025 for Testing Laboratories. The NVLAP accreditation encompasses Electromagnetic Compatibility Testing in accordance with the European Union EMC Directive 2004/108/EC, and ANSI C63.4. Additionally, Northwest EMC is accredited by NVLAP to perform radio testing in accordance with the European Union R&TTE Directive 1999/5/EEC, the requirements of FCC, and the RSS radio standards for Industry Canada. NVLAP LAB CODE 200629-0 NVLAP LAB CODE 200630-0 NVLAP LAB CODE 200676-0 NVLAP LAB CODE 200761-0 Industry Canada: Accredited by NVLAP for performance of Industry Canada RSS and ICES testing. Our Open Area Test Sites and certification chambers comply with RSS-Gen, Issue 2 and have been filed with Industry Canada and accepted. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by NIST and recognized by Industry Canada as a Certification Body (CB) per the APEC Mutual Recognition Arrangement (MRA). This allows Northwest EMC to certify transmitters to Industry Canada technical requirements. ( Site Filing Numbers - Hillsboro: 2834D-1, 2834D-2, Sultan: 2834C-1, Irvine: 2834B-1, 2834B-2) CAB: Designated by NIST and validated by the European Commission as a Conformity Assessment Body (CAB) to conduct tests and approve products to the EMC directive and transmitters to the R&TTE directive, as described in the U.S. - EU Mutual Recognition Agreement. TÜV Product Service: Included in TUV Product Service Group's Listing of Recognized Laboratories. It qualifies in connection with the TUV Certification after Recognition of Agent's Testing Program for the product categories and/or standards shown in TUV's current Listing of CARAT Laboratories, available from TUV. A certificate was issued to represent that this laboratory continues to meet TUV's CARAT Program requirements. Certificate No. USA0604C. TÜV Rheinland: Authorized to carryout EMC tests by order and under supervision of TÜV Rheinland. This authorization is based on "Conditions for EMC-Subcontractors" of November 1992. Northwest EMC Accreditations and Authorizations Revision 03/18/05 NEMKO: Assessed and accredited by NEMKO (Norwegian testing and certification body) for European emissions and immunity testing. As a result of NEMKO's laboratory assessment, they will accept test results from Northwest EMC, Inc. for product certification (Authorization No. ELA 119). Australia/New Zealand: The National Association of Testing Authorities (NATA), Australia has been appointed by the ACA as an accreditation body to accredit test laboratories and competent bodies for EMC standards. Accredited test reports or assessments by competent bodies must carry the NATA logo. Test reports made by an overseas laboratory that has been accredited for the relevant standards by an overseas accreditation body that has a Mutual Recognition Agreement (MRA) with NATA are also accepted as technical grounds for product conformity. The report should be endorsed with the respective logo of the accreditation bod…

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NORTHWEST EMC TEST EQUIPMENT IDInterval AAX12 MEASUREMENT UNCERTAINTY TEST DESCRIPTION 10/1/2007 DescriptionManufacturerModel Measurement uncertainty is used to reflect the accuracy of the measured result as compared with its "true" or theoretically correct value. Our measurement data meets or exceeds the measurement uncertainty requirements of CISPR 16-4. In the case of transient tests our test equipment has been demonstrated by calibration to provide at least a 95% confidence that it complies with the test specification requirements. The measurement uncertainty for any test is available upon request. Power Spectral Density XMit 2007.06.13 Last Cal. Testing was performed using the mode(s) of operation and configuration(s) noted within the report. The individuals and/or the organization requesting the test provided the modes, configurations and settings used to complete the evaluation. The actual test parameters are specified in the test data, this includes items such as investigated frequency range (scanned) and test levels. The testing methods and performance specifications, as well as the test site used for the evaluation are indicated in the test data. Spectrum AnalyzerAgilentE4440A The peak power spectral density measurements were measured with the EUT set to low, mid, and high transmit frequencies. The measurement was made using a direct connection between the RF output of the EUT and the spectrum analyzer. The EUT was transmitting at its maximum data rate for each modulation type available. Per the procedure outlined in FCC KDB 558074, March 23, 2005, the spectrum analyzer was used as follows: The emission peak(s) were located and zoom in on within the passband. The resolution bandwidth was set to 3 kHz, the video bandwidth was set to greater than or equal to the resolution bandwidth. The sweep sp…

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