VKF-RADIUSRadius-7

Radius-7™ Wearable Pulse CO-Oximeter Operator's Manual www.masimo.com 3 Masimo These operating instructions intend to provide the necessary information for proper operation of the Radius-7 Wearable Pulse CO-Oximeter. The Operator's Manual describes how Radius-7 information is displayed when used with Root, including display details as well as accessing and changing user-configurable settings. For additional information related to Root, refer to the Operator's Manual for Root. 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 Radius-7 Wearable Pulse CO-Oximeter are prerequisites for proper use. Do not operate the Radius-7 Wearable Pulse CO-Oximeter without completely reading and understanding these instructions. Cleared Use Only: The device and related accessories are CE Marked for non-invasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the instructions for use or labeling. 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. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. 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: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany E357969 MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005, CAN/CSA C22.2 No. 60601-1:2008, and applicable Particular (IEC 60601-2-49:2011, EN/ISO 80601-2-61:2011 and related Collateral (ANSI/AAMI/IEC 60601-1-8:2006) Standards for which the product has been found to comply by UL. Patents: www.masimo.com/patents.htm. ®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, Masimo®, Pulse CO-Oximeter®, PVI®, rainbow®, rainbow Resposable®, RRa®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®, SpMet® are federally registered trademarks of Masimo Corporation. Radius-7™, rainbow Acoustic Monitoring™, RAM™ Adaptive Threshold Alarm™, In Vivo Adjustment™ and RRp™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. © 2014 Masimo Corporation. Radius-7 Contents www.masimo.com 4 Masimo Contents About this Manual ------------------------------------------------------------------------------------------- 7 Product Description, Features and Indications for Use ---------------------------------------------- 9 Product Description ------------------------------------------------------------------------------------ 9 Indications for Use ------------------------------------------------------------------------------------- 9 Safety Information, Warnings and Cautions ---------------------------------------------------------- 11 Safety Warnings and Cautions----------------------------------------------------------------------- 11 Performance Warnings and Cautions--------------------------------------------------------------- 12 Cleaning and Service Warnings and Cautions ---------------------------------------------------- 16 Compliance Warnings and Cautions---------------------------------------------------------------- 16 Chapter 1- Technology Overview ------------------------------------------------------------------------ 19 Signal Extraction Technology® (SET®) ------------------------------------------------------------ 19 rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 22 rainbow Acoustic Monitoring™ (RAM™) ------------------------------------------------------------ 25 In Vivo Adjustment™ ---------------------------------------------------------------------------------- 27 Signal IQ® (SIQ) --------------------------------------------------------------------------------------- 28 Adaptive Threshold Alarm (ATA)-------------------------------------------------------------------- 29 FastSat® (FST®) --------------------------------------------------------------------------------------- 29 Sensitivity Modes ------------------------------------------------------------------------------------- 30 Chapter 2- System Components ------------------------------------------------------------------------ 31 General System Description ------------------------------------------------------------------------- 31 Radius-7 Instrument Module------------------------------------------------------------------------- 31 Radius-7 Battery Module ------------------------------------------------------------------------------ 33 Radius-7 Armband ------------------------------------------------------------------------------------- 34 Battery Charging Adapter ---------------------------------------------------------------------------- 34 Chapter 3- Setup------------------------------------------------------------------------------------------- 35 Unpacking and Inspection --------------------------------------------------------------------------- 35 Preparation for Use ------------------------------------------------------------------------------------ 35 Charging the Radius-7 Battery Module ------------------------------------------------------------- 36 Connecting Radius-7 to Root via Bluetooth ------------------------------------------------------- 36 Securing Radius-7 to Patient ------------------------------------------------------------------------ 37 Removing Radius-7 from P…

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FCC Compliance Opinion 2015-1-14 MASI0214 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 MASI0214 Model RADIUSL-7 FCC ID VKF-Radius Agent Michael Clark Approval Type Original Equipment Class DSS Direct Sequence Spread Spectrum Transmitter Rule Part 15.247 Overview The Radius is a pulse CO-Oximeter which contains a bluetooth radio to allow connecting to a Model RDS-7/ROOT general floor monitor in hospital environments. 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 Dave Tolman, TCB Committee 4/21/2015

July 22-2014 Dear Application Examiner: Masimo Corporation is submitting this application for the certification of their model Radius-7 Pulse CO-Oximeter. It is an LCD screen based display body worn, battery operated, pulse CO-Oximeter with a patient sensor for arterial oxygen saturation, pulse rate, perfusion index and a patient sensor for acoustic respiration rate. It contains a radio interface to allow Bluetooth wireless connection to Model RDS-7/ROOT general floor monitor in the hospital. The technical reports and exhibits demonstrate compliance with FCC Part 15.247. The applicant’s radio is compliant with FCC Part 15.247. FCC ID: VKF-Radius Please treat the contents of this application in a confidential manner. Your efforts in reviewing this application are greatly appreciated. Regards, Michael Clark

Request for Confidentiality Letter-FCC 6-26-2014 NWEMCTCB To whom it may concern, We hereby respectfully request that under the provision of 47 CFR 0.459 and 0.457(d) the documents listed below and attached with this application for certification be provided with confidential status.  Schematics.pdf  Operational Description.pdf  Frequency Block Diagrams.pdf 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, Michael Clark Engineer Senior Test R&D Instruments

Ethertronics’ Prestta series of Isolated Magnetic Dipole™ (IMD) trace antennas address the challenges facing today’s product designers. IMD’s high perfor- mance and isolation characteristics offer better con- nectivity and minimal interference. IMD antennas can be used in a variety of devices:  Notebook Computers  Access Points  WiFi enabled Televisions & Monitors PRODUCT: WLAN Prestta TM WLAN Embedded Antenna 2.4/4.9/5.2/5.8 GHz (802.11 a/b/g/n + Japan) Part No. 9000129 & 9000130 TECHNOLOGY ADVANTAGES Prestta WLAN antennas use patented IMD technology in a trace configuration to provide high performance. IMD antennas requires a smaller design keep-out area, carry lower program development risk which yields a quicker time-to-market, without sacrificing RF performance. Stays in Tune IMD antenna technology provides superior RF field containment, resulting in less interaction with surrounding components. Ethertronics IMD antennas resist de-tuning; providing a robust radio link regardless of the usage position. KEY BENEFITS SERVICE AND SUPPORT Extensive RF Experience  Our WLAN antennas are supported by documentation, and when needed, by the expertise of RF engineers who have integrated hundreds of antenna designs into wireless devices. Global Operations & Design Support  Ethertronics’ global operations supports an integrated network of design centers that can take projects from concept to production. END USER ADVANTAGES Unique Form Factors Support Advanced Industrial Designs  Smaller, more efficient IMD embedded antennas break through restrictive design rules and provide new free- dom in component placement. Superior Range & Signal Strength  Better antenna function means longer range and great- er sensitivity to critically precise signals—delivering greater customer satisfaction while building brand loy- alty. DESIGN ADVANTAGES Quicker Time-to-Market  By optimizing antenna size, performance and emis- sions, customer and regulatory specifications are more easily met. Greater Flexibility  Ethertronics’ first-in-class IMD technology enables you to develop concept designs that are more advanced and that deliver superior performance in reception- critical applications.  Multiple cable lengths to fit a variety of devices. RoHS Compliant  Ethertronics’ antennas are fully compliant with the European RoHS Directive 2002/95/EC. ETHERTRONICS 5501 Oberlin Drive, Suite 100, San Diego, CA. 92121, USA www.ethertronics.com Tel +(1) 858.550.3820 | fax +(1) 858.550.3821 | contact: [email protected] PRODUCT: WLAN a/b/g/n + Japan - P/N 9000129 & 9000130 Dimensions 42.0 x 8.0 x 0.8 mm Weight 0.4 g Cable / Connector U.fl Connector, 1.13mm diameter coaxial cable. Cable Length 100mm cable Main Antenna Substrate P/N 9000129: Based on PCB substrate P/N 9000130: Based on FPC substrate Mechanical Specification Ethertronics’ Internal (Embedded) Antenna Specifications. Below are the typical specs for a WLAN application. Electrical Specification Typical Characteristics (In reference device housing made of PC/ABS plastic) WLAN a/b/g/n + Japan Antenna (GHz) 2.390-2.490 b, g 4.900-5.100 Japan 5.150-5.350 a 5.35-5.90 a Peak Gain in dBi 2.0 4.0 5.0 6.0 Efficiency 65% 72% 72% 65% Return Loss in dB < -10.0 < -10.0 < -10.0 < -10.0 Feed Point Impedance 50 Ω unbalanced (other if required) Return Loss in dB Efficiency in % ETHERTRONICS 5501 Oberlin Drive, Suite 100, San Diego, CA. 92121, USA www.ethertronics.com Tel +(1) 858.550.3820 | fax +(1) 858.550.3821 | contact: [email protected] Ethertronics’ Internal (Embedded) Antenna Specifications. Below are the typical specs for a WLAN application. 2.4GHz 5GHz © 2013 Ethertronics. All rights reserved. Ethertronics, the Ethertronics logo, shaping antenna technology, Prestta, Savvi, Tavvel, Isolated Magnetic Dipole and the iMD logo are trademarks of Ethertronics. All other trademarks are the property of their respective owners. Specifications subject to change and are dependent upon actual implementation. 9000129 & 9000130 1May2013 PRODUCT: WLAN a/b/g/n + Japan - P/N 9000129 & 9000130

RF Exposure Evaluation FCC ID: VKF-RADIUS The device is excluded from SAR evaluation and therefore deemed compliant with FCC RF exposure requirements as described below: FCC KDB 447498 D01 v05r02 Section 4.3.1 “The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, where  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation  The result is rounded to one decimal place for comparison  3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion.” The device has a maximum conducted output power of 11.9 mW at 2441 MHz. The EUT has an antenna gain of 2 dBi for a maximum EIRP of 18.9 mW. The closest spacing of the antenna to the user’s extremity is 6mm. Per the following description provided by the manufacturer, the maximum duty cycle is 6%, and the closest spacing is 6mm: “The software sends 120 bytes @ 62.5 Hz for 7500 bytes per second or 60K bits/sec. Worst duty cycle will be when in 1 Mbit/sec mode which is 60K/1 M for a duty cycle of about 6%. The wireless transmission is for patient telemetry data only. The thickness of the enclosure from where antenna is located to the bottom of the enclosure is 3.15 mm, the thickness of the armband strap is 3 mm.” . The table below shows the results of the calculation. The value of 0.186 is well below the exclusion threshold of 3.0, therefore the unit is excluded from SAR evaluation and deemed compliant with FCC RF exposure requirements. Output Power Duty Cycle Test Separation Transmit Frequency Exclusion Threshold Specification (mW) (mm) (GHz) 11.9 0.06 6 2.44 0.186 <=3.0

Masimo Corporation Radius-7 FCC 15.247:2014 Report #: MASI0214 Rev. 1 Report Prepared By Northwest EMC Inc. NORTHWEST EMC – (888) 364-2378 – www.nwemc.com California – Minnesota – Oregon – New York – Washington WTD 12.5.23 CERTIFICATE OF TEST Last Date of Test: June 18, 2014 Masimo Corporation Model: Radius-7 Emissions Test Description Specification Test Method Pass/Fail Duty Cycle FCC 15.247:2014 ANSI C63.10:2009 Pass Occupied Bandwidth FCC 15.247:2014 ANSI C63.10:2009 Pass Output Power FCC 15.247:2014 ANSI C63.10:2009 Pass Spurious Conducted Emissions FCC 15.247:2014 ANSI C63.10:2009 Pass Band Edge Compliance FCC 15.247:2014 ANSI C63.10:2009 Pass Band Edge Compliance Hopping Frequency FCC 15.247:2014 ANSI C63.10:2009 Pass Channel Separation FCC 15.247:2014 ANSI C63.10:2009 Pass Number of Hopping Channels FCC 15.247:2014 ANSI C63.10:2009 Pass Dwell Time FCC 15.247:2014 ANSI C63.10:2009 Pass Spurious Radiated Emissions FCC 15.247:2014 ANSI C63.10:2009 Pass Deviations From Test Standards None Approved By: Victor Ratinoff, Operations 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. REV 2012.08.02 REVISION HISTORY Revision Number Description Date Page Number 00 None 01 Corrected mistake on configurations page. Changed to no ferrite use. 7-15-14 8 Barometric Pressure The recorded barometric pressure has been normalized to sea level. REV 2012.05.24 ACCREDITATIONS AND AUTHORIZATIONS United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea KCC / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. Russia GOST – Accredited by Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC to perform EMC and Hygienic testing for Information Technology products to GOST standards. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ REV 2013.03.8 MEASUREMENT UNCERTAINTY Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document WP 342. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) for each test is listed below. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-1 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests that may be contained in this report. Test + MU - MU Frequency Accuracy (Hz) 0.12 -0.01 Amplitude Accuracy (dB) 0.49 -0.49 Conducted Power (dB) 0.41 -0.41 Radiated Power via Substitution (dB) 0.69 -0.68 Temperature (degrees C) 0.81 -0.81 Humidity (% RH) 2.89 -2.89 Field Strength (dB) 3.80 -3.80 AC Powerline Conducted Emissions (dB) 2.94 -2.94 REV 2013.06.28 FACILITIES Oregon Labs EV01-12 22975 NW Evergreen Pkwy Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs NY01-04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs NC01-05,SU02,SU07 19201 120 th Ave. NE Bothell, WA 98011 (425) 984-6600 VCCI A-0108 A-0029 A-0109 A-0110 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834F-1 NVLAP NVLAP Lab Code: 200630-0 NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200761-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200629-0 WTD 12.5.23 PRODUCT DESCRIPTION Client and Equipment Under Test (EUT) Information Company Name: Masimo Corporation Address: 40 Parke…

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DUTY CYCLE XMit 2014.02.07 NORTHWEST DUTY CYCLE PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG DUTY CYCLE DUTY CYCLE XMit 2014.02.07 NORTHWEST DUTY CYCLE PsaTx 14.04.29.1 EMC Dir Conn (3).JPG DUTY CYCLE OCCUPIED BANDWIDTH XMit 2014.02.07 NORTHWEST OCCUPIED BANDWID PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG OCCUPIED BANDWIDTH OCCUPIED BANDWIDTH XMit 2014.02.07 NORTHWEST OCCUPIED BANDWID PsaTx 14.04.29.1 EMC Dir Conn (3).JPG OCCUPIED BANDWIDTH OUTPUT POWER XMit 2014.02.07 NORTHWEST OUTPUT POWER PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG OUTPUT POWER OUTPUT POWER XMit 2014.02.07 NORTHWEST OUTPUT POWER PsaTx 14.04.29.1 EMC Dir Conn (3).JPG OUTPUT POWER SPURIOUS CONDUCTED EMISSIONS XMit 2014.02.07 NORTHWEST SPURIOUS CONDUCT PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG SPURIOUS CONDUCTED EMISSIONS SPURIOUS CONDUCTED EMISSIONS XMit 2014.02.07 NORTHWEST SPURIOUS CONDUCT PsaTx 14.04.29.1 EMC Dir Conn (3).JPG SPURIOUS CONDUCTED EMISSIONS BAND EDGE COMPLIANCE XMit 2014.02.07 NORTHWEST BAND EDGE COMPLI PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG BAND EDGE COMPLIANCE BAND EDGE COMPLIANCE XMit 2014.02.07 NORTHWEST BAND EDGE COMPL PsaTx 14.04.29.1 EMC Dir Conn (3).JPG BAND EDGE COMPLIANCE BAND EDGE COMPLIANCE XMit 2014.02.07 NORTHWEST BAND EDGE COMPLI PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG BAND EDGE COMPLIANCE BAND EDGE COMPLIANCE XMit 2014.02.07 NORTHWEST BAND EDGE COMPLI PsaTx 14.04.29.1 EMC Dir Conn (3).JPG BAND EDGE COMPLIANCE CHANNEL SEPERATION XMit 2014.02.07 NORTHWEST CHANNEL SEPERATI PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG CHANNEL SEPERATION CHANNEL SEPERATION XMit 2014.02.07 NORTHWEST CHANNEL SEPERATI PsaTx 14.04.29.1 EMC Dir Conn (3).JPG CHANNEL SEPERATION NUMBER OF HOPPING FREQUENCIES XMit 2014.02.07 NORTHWEST NUMBER OF HOPPIN PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG NUMBER OF HOPPING FREQUENCIES NUMBER OF HOPPING FREQUENCIES XMit 2014.02.07 NORTHWEST NUMBER OF HOPPIN PsaTx 14.04.29.1 EMC Dir Conn (3).JPG NUMBER OF HOPPING FREQUENCIES DWELL TIME XMit 2014.02.07 NORTHWEST DWELL TIME PsaTx 14.04.29.1 EMC Dir Conn (1).JPG Dir Conn (2).JPG DWELL TIME DWELL TIME XMit 2014.02.07 NORTHWEST DWELL TIME PsaTx 14.04.29.1 EMC Dir Conn (3).JPG DWELL TIME photo SEB, EUT Horiz, FCC (1).JPG SEB, EUT Horiz, FCC (2).JPG SPURIOUS RADIATED EMISSIONS PSA-ESCI 2014.04.28 photo SEB, EUT Horiz, FCC (3).JPG SEB, EUT on Side, FCC (1).JPG SPURIOUS RADIATED EMISSIONS PSA-ESCI 2014.04.28 photo SEB, EUT on Side, FCC (2).JPG SEB, EUT on Side, FCC (3).JPG SPURIOUS RADIATED EMISSIONS PSA-ESCI 2014.04.28 photo SEB, EUT Vert, FCC (1).JPG SEB, EUT Vert, FCC (2).JPG SPURIOUS RADIATED EMISSIONS PSA-ESCI 2014.04.28 photo SEB, EUT Vert, FCC (3).JPG SPURIOUS RADIATED EMISSIONS PSA-ESCI 2014.04.28