Rad-67™ Pulse CO-Oximeter®

Rad-67™ Pulse CO-Oximeter® Featuring Masimo SET® Measure-through Motion* and Low Perfusion™ Pulse Oximetry and Noninvasive Total Hemoglobin (SpHb®) Spot-check Monitoring

SpO2 Oxygen Saturation*

PR Pulse Rate*

Pi Perfusion Index

SpHb® Total Hemoglobin**

More Than a Conventional Pulse Oximeter

Compatible with the Display spot-check monitoring results with Label spot-check monitoring measurements rainbow® DCI®-mini sensor signal quality indicators for signal stability, with unique patient identifiersfor convenient low perfusion, and ambient light interference historical data review directly on the device

IPX4 ISO 80601-2-61 540–1,060 mBar 0.81 lbs (0.37 kg) 32–95º F (0–35º C) 32–95º F (0–35º C) EN 60601-1-2, Class B Continuous Operation 10-95%, non-condensing10-95%, 1 Class II (Internally Powered) Type Defib BF, Proof-Applied Part This represents approximate represents This approximate No. 60601-1, IEC/EN 60601-1, 3rd Ed. 2 ANSI/AAMI ES 60601-1, CAN/CSA C22.2 of the reference measurements in 7.6” x 3.2” cm x 0.9” x 8.27.6” (19.43 cm x 2.36 cm) RMS

2 Results displayed in as few as 30 seconds ...... Masimo International Masimo Tel: +41 32 720 1111 [email protected] accuracy is a statistical calculation of the difference ...... RMS ...... A ...... 3 ...... Bright LCD, color display mode power low Automatic to conserve power sensor light Ambient automatically adjusts screen brightness to optimize visibility 6 hours charging time Li-ion Battery Up to 6 hours battery life ......

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...... HD Display HD Auto-Brightness Rechargeable BatteryRechargeable

Masimo U.S. Masimo Tel: 1 877 4 Masimo [email protected] Pulse Oximeter Standard(s) Standard(s)IEC Protection of Degree Mode of Operation (per IEC 60601-1) ...... Protection of Degree Enclosure Safety Standard(s) Type of Protection of Type Operating Humidity Dimensions Operating Temperature PressureAtmospheric Weight 4 COMPLIANCE ENVIRONMENTAL PHYSICAL CHARACTERISTICS 4

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4 2.07 -1.82 5 bpm 3 bpm 3 bpm automate workflow 70–100% 8–17 g/dL On-screen guidance to 25–240 bpm , pulse 2 ...... 3 with a slim profile design provides tactile connection proper upon feedback Redesigned sensor connector port ) ...... 3 ) RMS ...... 3 ) ...... RMS RMS DCI-mini sensor ** sensor DCI-mini ...... (Pi) using the rainbow® Measure SpHb, SpO rate (PR), and perfusion index ) Accuracy Range ...... 2 ...... allows users to 3 ) ...... 3 The differences between measurements by the two methods are used to calculate the mean and standard deviation. The lower 95% limit of agreement ) 4 RMS ...... 4 compatibility enables 4 3 ) RMS RMS No Motion (A No Motion Adults/Pediatrics/Infants (A Low Perfusion (A Motion (A Upper 95% LoA Low Perfusion Adults/Pediatrics/Infants (A Motion Adults/Pediatrics/Infants (A Lower 95% LoA Pulse Rate (PR) Accuracy Range ACCURACY Oxygen (%SpO Saturation SpHb Limits of Agreement (LoA) Total Hemoglobin (SpHb) Accuracy Range Next Generation SpHb technology in Rad-67 is available only when used with compatible sensors with Next Generation SpHb technology. Intuitive touchscreenIntuitive quickly navigate the user interface with gestures finger is the mean minus standard 1.96 deviation and the upper 95% limit of agreement is the mean subjects. sick and plus performed standard healthy was Accuracy on differences environments. SpHb testing controlled for between 1.96 between in measurements two methods the deviation. These limits are expected to contain 95% of the ** SpHb indicated for adult patients only. Rad-67 is not licensed for sale in Canada. SpHb is not intended for use on pediatric patients, pregnant patients, and patients with renal disease. Caution: Federal (USA) law restricts this device to sale by the on or order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. SpHb monitoring with Rad-67 is not intended to replace laboratory blood testing. Blood samples be should analyzed laboratory by instruments prior clinical to decision making. 1 Rad-67 Specifications Rad-67 Wireless printer clinicians to print results at the point of care Features Masimo SET® Combined with Next Generation SpHb Spot-check Monitoring Technology Monitoring Spot-check SpHb Next with Generation SET® Combined Masimo runtime at the lowest indicator brightness and wireless functionality powered off using a fully-charged battery. between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within ± A within fell measurements device the two-thirds measurements. Approximately of reference and measurements between device a controlled study.