FCC ID: VKF-AIRTB01 Radius PPG reusable chip

Radius PPG Chip and Receiver

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+1060 hPa - +500 hPa 795 mmHg - 375 mmHg LATEX Enthlt keinen Latex aus Naturkautschuk NON STERILE Nicht steril 5%-95% RH LATEX Non contiene lattice di gomma naturale NON STERILE Non sterile 5%-95% RH PCX-2108A 02/13 LATEX 95%

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PCX-2108A 02/13 LATEX Prior to using this product the user should read and understand the Operators Manual for the device/monitor, The Directions for Use for the sensor, and this Directions for Use. INDICATIONS Masimo Radius PPG is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR). Masimo Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin

(SpO2) and pulse rate (PR) for use with adult, pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities and home environments. Devices with Masimo technology are only to be used with Masimo sensors and cables. CONTRAINDICATIONS The Radius PPG is contraindicated for patients who exhibit allergic reactions to foam rubber products and/or adhesive tape. DESCRIPTION Radius PPG consists of three parts:

Radius PPG wireless receiver Radius PPG reusable chip Radius PPG adhesive sensor (shipped seperately, see Directions for Use for the Radius PPG Adhesive Sensor)

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Radius PPG is a wireless sensor for use with devices containing Masimo technology MX Version 7.14.8.x. or higher. Consult individual device manufacturers for compatibility of particular device and sensor models. Each device manufacturer is responsible for determining whether their device is compatible with each sensor model. WARNINGS, CAUTIONS, AND NOTES Do not leave the sensor components unattended around children. Small items may become choking hazards. To ensure continued monitoring, routinely verify the wireless connection. When using multiple Radius PPG sensors, repeat pairing before monitoring to ensure proper wireless connection. When using Radius PPG, keep it within the recommended range from the connected host (see Wireless Technology Information for details); moving outside of this range may cause a loss in connection with the host device. When using Radius PPG, relocate the devices away from sources that may interfere with the Bluetooth connection. The presence of other devices that may create radio frequency interference (RFI) may result in loss of Quality of Service (see Specifications for details) of the Bluetooth connection. Devices that may cause RFI include but are not limited to the following: electrocautery equipment, diathermy equipment, other cellular telephones, wireless PC and tablets, pagers, RFID devices, MRI, and electromagnetic security systems. INSTRUCTIONS a) Initial setup 1. Verify you have all components. Refer to Fig. 1. A. Radius PPG adhesive sensor B. Radius PPG wireless bluetooth receiver C. Radius PPG reusable chip D. Radius PPG reusable chip holder for device Turn on the patient monitor. 2. 3. Plug the cable into the patient monitor. Refer to Fig. 2. The light on wireless receiver will be white. 4. Attach the wireless receiver to the side of the patient monitor using the adhesive provided. Refer to Fig. 3. 5. Avoid covering speakers or holes used for mounting when attaching the module. Refer to Fig. 4. 6. Attach the chip holder near the receiver on the patient monitor. Refer to Fig. 5. 7. Verify that the wireless receiver is attached and plugged in to patient monitor. Verify that the chip holder is attached to patient monitor. Refer to Fig. 6. b) Pairing the reusable transmitter chip with the wireless receiver 1. Ensure the device is powered on. Refer to Fig. 7. 2. Hold the reusable chip to the indent on the wireless receiver until the Bluetooth symbol on the wireless receiver turns green. Refer to Fig. 8. Insert the reusable chip into the sensor attachment strap until there is a tactile or audible click of connection. Refer to Fig. 9. 3. 4. Verify the light on the wireless receiver turns blue. (See LIGHT INDICATOR GUIDE section.) c) Disconnecting 1. Push down on the tab to release the reusable chip from the sensor. Refer to Fig. 10. 2. After cleaning, store the reusable chip in the chip holder attached to the patient monitor. Refer back to Fig. 6. 3. Discard the adhesive sensor and strap. CLEANING WARNING: Before cleaning, make sure the device is off and is not applied to a patient. Thoroughly clean the Radius PPG reusable chip and wireless receiver before applying to a new patient. To surface clean the reusable chip and wireless receiver:

1. Remove the sensor from the patient and disconnect the reusable chip. 2. Wipe all surfaces of the reusable chip and wireless receiver with one of the following:

a. 70% Isopropyl alcohol b. 10% (1:10) chlorine bleach to water solution c. Quaternary ammonium chloride solution 3. Allow the reusable chip and wireless receiver to dry thoroughly before using again. CAUTIONS:

To avoid permanent damage to the reusable chip and wireless receiver, do not use undiluted bleach (5% - 5.25%

sodium hypochlorite) or any other cleaning solution not recommended. Do not immerse the reusable chip and wireless receiver in any liquid solution. Do not sterilize by irradiation, steam, autoclave or ethylene oxide. LIGHT INDICATOR GUIDE Color Wireless receiver Transmitter chip Description Next steps No light

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White solid solid

(2 seconds) Green Wireless receiver cable is not connected to host device with power Chip not connected to sensor with battery Wireless receiver is connected to host device with power ready to initiate pairing with transmitter chip Paring search period has expired Chip and receiver are linked

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(30 seconds) Pairing search period Blue solid flashing Successful pairing of receiver and chip Purple flashing flashing Battery seal tab has not been removed to activate battery Battery is obstructed Orange flashing flashing Low sensor battery Red flashing flashing Depleted sensor battery Hardware or sensor failure, chip blinking board failure code Turn on patient monitor and plug cable into patient monitor See Instructions, section a) for set up Hold reusable chip to the indent on the wireless receiver to initiate pairing See Instructions, section b) for pairing Insert reusable chip into sensor attachment strap to complete pairing See Instructions, section b) for pairing Verify sensor attachment so host device can receive data Remove tab to activate battery Refer to Directions for Use for the Radius PPG Adhesive Sensor Disconnect reusable chip from sensor, wait 30 seconds, insert chip into sensor

(Refer to Figs. 9 and 10.) Consider replacing sensor, do not discard reusable chip See Instructions, section c) for disconnecting Replace sensor, do not discard reusable chip. If issue persists, replace reusable chip See Instructions, section c) for disconnecting Contact Masimo Technical Support, or replace sensor and chip ACCURACY SPECIFICATIONS (Arms*) Oxygen Saturation (SpO2) SpO2 Accuracy, No Motion1

(70100%) SpO2 Accuracy, Motion2 SpO2 Accuracy, Low Perfusion3 Adults, Pediatrics, Infants Neonates5 All patient populations All patient populations 2%

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Pulse Rate4 (PR) 25240bpm All patient populations No Motion Motion Low Perfusion 3 bpm 5 bpm 3 bpm

*NOTE: Arms accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- Arms of the reference measurements in a controlled study. 1 The Masimo SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70%-100% SpO2 against a laboratory co-oximeter. 2 The Masimo SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70%-100%

SpO2 against a laboratory co-oximeter. 3 The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimos simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%. 4 The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator and Masimos simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%. 5 The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for the properties of fetal hemoglobin. ENVIRONMENTAL SPECIFICATIONS Storage/Transport Temperature Operating Temperature Storage/Transport Humidity Operating Humidity Atmospheric Pressure BATTERY LIFE

-40C - +70C @ ambient humidity 0C - 40C @ ambient humidity 5% - 95% non-condensing 5% - 95% non-condensing 540 to 1060 mBar @ ambient temperature and humidity Battery Life 96 hours in typical continuous usage WIRELESS TECHNOLOGY INFORMATION Bluetooth LE Wireless Technology Information Modulation Type Max. Output Power Frequency Range Antenna Peak Gain Recommended Range Quality of Service (QoS) Security GFSK

+8 dBm 2402 MHz - 2480 MHz 1 dBi 100 ft (~30 meters) line-of-sight Delay <30 seconds Proprietary binary protocol FCC ID are as follows: Chip: VKF-AIRTB01 Receiver: VKF-AIRDG01 IC IDs are as follows: Chip: 7362A-AIRTB01 Receiver: 7362A-AIRDG01 EU Radio Equipment Directive (RED 2014/53/EU) Radius PPG Receiver:

Radius PPG Chip:

EN 301 489-17 V3.1.1 EN 301 489-3 V2.1.1 EN 300 328 V2.2.1 EN 300 330 V2.1.0 EN 301 489-17 V3.1.1 EN 300 328 V2.2.1 WARNING: Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. WARNING: The frequency bands of this device (2.4 GHz) are only for indoor use, in accordance with international telecommunication requirements. CAUTION: Keep the Radius PPG away from electrical equipment that emits radio frequencies to minimize radio interference. Radio interference may result in no or inaccurate readings. Note: This device complies with part 15 of FCC Rules and Industry Canadas license-exempt RSSs. Operation is subject to the following 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. Note: When using Radius PPG consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless devices. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. 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 radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, 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 antenna. Consult the dealer or an experienced radio/TV technician for help. Increase the separation between the equipment and receiver. RF Radiation Exposure Statement: This equipment has been exempted from FCC RF radiation exposure testing set forth for an uncontrolled environment. Note: Users are advised that high-power radars are allocated as primary users (i.e. priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices RF Radiation Exposure Statement: Radius PPG Receiver has been exempted from IC RSS 102 RF radiation exposure limits set forth for an uncontrolled environment. WARRANTY Masimo warrants to the initial buyer only that these products, when used in accordance with the directions provided with the Products by Masimo, will be free of defects in materials and workmanship for a period of six (6) months. Single use products are warranted for single patient use only. THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER. MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. MASIMOS SOLE OBLIGATION AND BUYERS EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MASIMOS OPTION, TO REPAIR OR REPLACE THE PRODUCT. WARRANTY EXCLUSIONS This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product, or has been subject to misuse, neglect, accident or externally created damage. This warranty does not extend to any product that has been connected to any unintended device or system, has been modified, or has been disassembled or reassembled. This warranty does not extend to products that have been reprocessed, reconditioned or recycled. IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY THEREOF. IN NO EVENT SHALL MASIMOS LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER

(UNDER A CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN SUCH CLAIM. IN NO EVENT SHALL MASIMO BE LIABLE FOR ANY DAMAGES ASSOCIATED A PRODUCT THAT HAS BEEN REPROCESSED, RECONDITIONED OR RECYCLED. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT. NO IMPLIED LICENSE PURCHASE OR POSSESSION OF THIS PRODUCT DOES NOT CARRY ANY EXPRESS OR IMPLIED LICENSE TO USE WITH ANY DEVICE THAT IS NOT AN AUTHORIZED DEVICE OR SEPARATELY AUTHORIZED TO USE MASIMO PRODUCTS. RECOMMENDED SEPARATION DISTANCES RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATION EQUIPMENT AND THE ME EQUIPMENT The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ME Equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ME Equipment as recommended below, according to the maximum output power of the communication equipment. RATED MAXIMUM OUTPUT POWER OF TRANSMITTER (W) SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER (m) 800 MHz a 2.5 GHz d = 2.33*P 0.23 0.74 2.33 7.37 23.3 0.01 0.1 1 10 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 150 K Hz to 80 MHz d = 1.17*P 0.12 0.37 1.17 3.7 11.7 80 MHz to 800 MHz d = 1.17*P 0.12 0.37 1.17 3.7 11.7 CAUTION: FEDERAL LAW (U.S.A.) 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. The following symbols may appear on the product or product labeling:

SYMBOL DEFINITION SYMBOL DEFINITION SYMBOL DEFINITION STERILE LATEX 95%

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Follow instructions for use

(blue background) GR-10199B Separate collection for electrical and electronic equipment

(WEEE). Consult instructions for use Lot code

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+1060 hPa - +500 hPa 795 mmHg - 375 mmHg 5%-95% RH Manufacturer Date of manufacture YYYY-MM-DD Serial Number

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+1060 hPa - +500 hPa 795 mmHg - 375 mmHg NON STERILE LATEX LATEX Non-Sterile 5%-95% RH Not made with natural rubber latex Catalogue number (model number) Masimo reference number Light Emitting Diode (LED) LED emits light when current flows through X Greater than Less than Caution: Federal law (USA) restricts this device to sale by or on the order of a physician Mark of conformity to European Medical Device Directive 93/42/EEC Authorized representative in the European community Body weight Storage temperature range Keep dry Do not use if package is damaged Storage humidity limitation Atmospheric pressure limitation 95%

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Fragile, handle with care Protected against solid foreign objects of 1.0 mm diameter and greater and protected against the effects of temporary immersion in water. Federal Communications Commission (FCC) Licensing Protected against solid foreign objects of 12.5 mm diameter and greater and protection against vertically falling water drops when enclosure is tilted at 15 degrees. Identifies unit has been registered as a radio device Instructions/Directions for Use/

Manuals are available in electronic format @ http://www.Masimo.com/

TechDocs Note: eIFU is not available in all countries. Patents: http://www.masimo.com/patents.htm Radius PPG is a trademark of Masimo Corporation. Masimo, SET, X-Cal, and are federally registered trademarks of Masimo Corporation. es

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Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5 Fig. 6 Fig. 7 Fig. 8 Fig. 9 Fig. 10 Radius PPG Chip and Receiver EU Authorized Representative for Masimo Corporation:

MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany Manufacturer:

Masimo Corporation 52 Discovery Irvine, CA 92618 USA www.masimo.com 2019 Masimo Corporation 300633/10353BC-101219 Radius PPG Chip and Receiver sv Radius PPG Chip and Receiver nl Radius PPG Chip and Receiver da Radius PPG Chip and Receiver pt B R U K S A N V I S N I N G

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+1060 hPa - +500 hPa 795 mmHg - 375 mmHg Reusable LATEX Doal kauuk lateks ile retilmemitir NON STERILE Steril deildir 5%-95% RH PCX-2108A 02/13 LATEX 95%

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Date: 11/20/2019 To whom it may concern, Masimo Corporation is submitting the Radius PPG reusable chip for FCC original certification. Radius PPG reusable chip is 1.23 by 1.18 by 0.26 inches. With these dimensions, Masimo is planning to include the details of FCC ID in the user manual only. We would like to submit this letter to FCC to grant us exception from requiring to place the FCC ID on the Radius PPG chip reusable enclosure. Sincerely, Anamidevi Joshi EMC Project Manager Masimo Corporation

Antenna Info Radius PPG reusable chip has below antenna Item Radio Type Manufacturer Model Peak Gain (dBi) Description 1 Bluetooth Low Energy N/A Number N/A 1 Printed inverted-F antenna Printed Inverted-

F BT Antenna size demonstrated Figure 1: Bluetooth antenna located within the PCB Figure 2: Assembly drawing of Radius PPG reusable chip showing item # 3 that has Bluetooth antenna located within the outer housing indicated by item #1. The antenna is permanently attached and is non-replaceable. Figure 3: F-type antenna demonstatrated Figure 4: Other side of the chip

Cover letter for FCC application Masimo Corporation is submitting the Radius PPG reusable chip for FCC original certification. Radius PPG reusable chip utilizes below radio:

Bluetooth: utilizes nRF52840 radio with printed inverted-F antenna Radius PPG reusable chip pairs up with Radius PPG wireless receiver using NFC radio to establish communication over Bluetooth Low Energy to support continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and perfusion index (Pi). NFC is used only for pairing (MAC address transfer) the Radius PPG wireless receiver with Radius PPG reusable chip. After pairing, BLE communication is established. NFC radio and BLE radio do not transmit at the same time. Radius PPG reusable chip has been tested to 47 CFR FCC 15.247.Its FCC ID is VKF-AIRTB01. During radio testing the product was labelled as AIR01 Technology Board however during later phase of product release it has been re-named as Radius PPG reusable chip. But none the less both the names refer to same product. Respectfully, Anamidevi Joshi EMC Project Manager Masimo Corporation

Request for Confidentiality Letter-FCC Date: 12/06/2019 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality FCC ID: VFK-AIRTB01 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, Anamidevi Joshi EMC Project Manager Masimo Corporation