Rad-67 Pulse CO-Oximeter Operators Manual April 2019

For Sale in the USA These operating instructions provide the necessary information for proper operation of all models of the Rad-67. 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 Rad-67 are prerequisites for its proper use. Do not operate Rad-67 without completely reading and understanding these instructions. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked for noninvasive 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 directions 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Wireless Radio FCC ID: VKF-MWM1 Model Rad-67 IC: 7362A-MWM1 IC Model: MWM1 Masimo Corporation 52 Discovery 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

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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 (EN/ISO 80601-2-61:2011) and related Collateral (IEC 60601-1-8:2006) Standards for which the product has been found to comply by Intertek.

Patents: www.masimo.com/patents.htm ®, Adaptive Probe Off Detection®, APOD®, Masimo®, Pulse CO-Oximeter®, rainbow®, SET®, Signal Extraction Technology®, Signal IQ®, SpHb®, and X-Cal™ are federally registered trademarks of Masimo Corporation. Rad-67™ is a trademark of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. © 2019 Masimo Corporation

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Contents About This Manual-------------------------------------------------------------------------------------------7 Product Description, Features and Indications for Use----------------------------------------------- 9 Product Description ------------------------------------------------------------------------------------- 9 Indications for Use-------------------------------------------------------------------------------------- 9 Contraindications --------------------------------------------------------------------------------------- 9 Safety Information, Warnings and Cautions ---------------------------------------------------------- 11 Safety Warnings and Cautions ----------------------------------------------------------------------- 11 Performance Warnings and Cautions --------------------------------------------------------------- 12 Cleaning and Service Warnings and Cautions ---------------------------------------------------- 15 Compliance Warnings and Cautions ---------------------------------------------------------------- 15 Chapter 1: Technology Overview ------------------------------------------------------------------------ 19 Signal Extraction Technology® (SET®) ------------------------------------------------------------ 19 rainbow Pulse CO-Oximetry Technology® --------------------------------------------------------- 21 Chapter 2: Description ------------------------------------------------------------------------------------25 General System Description --------------------------------------------------------------------------25 Features --------------------------------------------------------------------------------------------------26 Chapter 3: Setting Up------------------------------------------------------------------------------------- 27 Unpacking and Inspection --------------------------------------------------------------------------- 27 Preparation for Use ------------------------------------------------------------------------------------ 27 Guidelines for Setting Up ----------------------------------------------------------------------------- 27 Initial Battery Charging ------------------------------------------------------------------------------- 27 Powering the Rad-67 ON and OFF -------------------------------------------------------------------28 Chapter 4: Operation --------------------------------------------------------------------------------------29 Using the Touchscreen and Home Button ---------------------------------------------------------29 About the Main Screen ------------------------------------------------------------------------------- 33 Accessing Main Menu Options ---------------------------------------------------------------------- 38 Parameter Settings ----------------------------------------------------------------------------------- 40 Additional Settings ------------------------------------------------------------------------------------43 Spot-Check Settings ----------------------------------------------------------------------------------- 44 Spot-Check Sessions ----------------------------------------------------------------------------------- 44 Sounds --------------------------------------------------------------------------------------------------- 47 www.masimo.com

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Device Settings ----------------------------------------------------------------------------------------- 47 About----------------------------------------------------------------------------------------------------- 54 Screenshot Capture ------------------------------------------------------------------------------------ 54 Chapter 5: Spot-Check ------------------------------------------------------------------------------------ 57 Performing a Spot-Check ----------------------------------------------------------------------------- 58 Spot-Check Results ------------------------------------------------------------------------------------ 61 Chapter 6: Alerts and Messages ------------------------------------------------------------------------ 63 About Alerts--------------------------------------------------------------------------------------------- 63 Messages ------------------------------------------------------------------------------------------------ 64 Chapter 7: Troubleshooting ------------------------------------------------------------------------------ 67 Troubleshooting Measurements--------------------------------------------------------------------- 67 Troubleshooting Rad-67 ------------------------------------------------------------------------------ 71 Chapter 8: Specifications -------------------------------------------------------------------------------- 75 Display Range ------------------------------------------------------------------------------------------ 75 Accuracy (ARMS*) ------------------------------------------------------------------------------------- 75 SpO2 Performance Specifications------------------------------------------------------------------- 76 SpHb Accuracy Data ----------------------------------------------------------------------------------- 77 Resolution ----------------------------------------------------------------------------------------------- 78 Electrical------------------------------------------------------------------------------------------------- 79 Environmental------------------------------------------------------------------------------------------ 79 Physical Characteristics ------------------------------------------------------------------------------ 79 Display Indicators------------------------------------------------------------------------------------- 80 Compliance -------------------------------------------------------------------------------------------- 80 Output Interface --------------------------------------------------------------------------------------- 81 Wireless Specifications ------------------------------------------------------------------------------- 81 Guidance and Manufacturer's Declaration-Electromagnetic Emissions---------------------- 83 Guidance and Manufacturer's Declaration-Electromagnetic Immunity ---------------------- 84 Recommended Separation Distances -------------------------------------------------------------- 87 Symbols--------------------------------------------------------------------------------------------------88 Citations ------------------------------------------------------------------------------------------------ 90 Chapter 9: Service and Maintenance ------------------------------------------------------------------ 93 Cleaning ------------------------------------------------------------------------------------------------- 93 Performance Verification ----------------------------------------------------------------------------- 93 www.masimo.com

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Maintenance --------------------------------------------------------------------------------------------94 Repair Policy ------------------------------------------------------------------------------------------- 95 Return Procedure -------------------------------------------------------------------------------------- 95 Contacting Masimo ----------------------------------------------------------------------------------- 95 Index -------------------------------------------------------------------------------------------------------- 99

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About This Manual This manual explains how to set up and use Rad-67™ Pulse CO-Oximeter®. Important safety information relating to general use of Rad-67 appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user. WARNING: This is an example of a warning statement. A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device, or damage to other property. CAUTION: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note.

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Product Description, Features and Indications for Use Product Description The Rad-67™ Pulse CO-Oximeter® is a non-invasive device intended to measure functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and perfusion index (Pi), along with optional non-invasive measurement of total hemoglobin (SpHb®). The following key features are available for Rad-67: 

Masimo® SET® and rainbow® SET technology performance.

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SpO2 and pulse rate measuring in motion and low perfusion environments.

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Spot-Check monitoring of total hemoglobin (SpHb).

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Wireless radio for transfer of parameter data.

Indications for Use The Masimo Rad-67™ Pulse CO-Oximeter® and Accessories are intended for use in clinical and non-clinical settings. The Masimo Rad-67™ Pulse CO-Oximeter® and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions. The Masimo Rad-67™ Pulse CO-Oximeter® and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb) for adult patients.

Contraindications The Rad-67 is not intended for use as an apnea monitor. The Rad-67 is not intended to measure hemoglobin (SpHb) on pregnant women.

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Safety Information, Warnings and Cautions CAUTION: Rad-67 is to be operated by, or under the supervision of, qualified personnel only. Read the manual, accessories directions for use, all precautionary information, and specifications before use.

Safety Warnings and Cautions WARNING: Do not use Rad-67 if it appears or is suspected to be damaged. Damage to the device can result in exposed electrical circuits that may cause patient harm. WARNING: Do not adjust, repair, open, disassemble, or modify the Rad-67. Damage to the device may result in degraded performance and/or patient injury. WARNING: Do not start or operate the Rad-67 unless the setup was verified to be correct. Improper set-up of this device may result in degraded performance and/or patient injury. WARNING: Do not place the Rad-67 or accessories in any position that might cause it to fall on the patient. WARNING: Only use Masimo authorized devices with Rad-67. Using unauthorized devices with Rad-67 may result in damage to the device and/or patient injury. WARNING: All sensors and cables are designed for use with specific devices. Verify the compatibility of the device, cable, and sensor before use; otherwise degraded performance and/or patient injury can result. WARNING: Do not use the Rad-67 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide to avoid risk of explosion. WARNING: Do not use the Rad-67 during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Rad-67 may be used during defibrillation. However, to reduce the risk of electric shock, the operator should not touch the Rad-67 during defibrillation. WARNING: To protect against electrical shock injury, follow the directions below: 

Avoid placing the device on surfaces with visible liquid spills.

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Do not soak or immerse the device in liquids.

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Do not attempt to sterilize the device.

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Use cleaning solutions only as instructed in this Operator's Manual.

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Do not attempt to clean the Rad-67 while monitoring patient.

WARNING: To ensure safety, avoid placing anything on the device during operation. WARNING: As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. CAUTION: Do not place the Rad-67 where the controls can be changed by the patient. CAUTION: Do not place Rad-67 where the AC power supply cannot be readily disconnected when used on AC power. www.masimo.com

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Safety Information, Warnings and Cautions

CAUTION: To ensure patient electrical isolation, all external device connections to the output interface port must be done using only authorized data cables. Note: Disconnect the device from AC mains by unplugging the AC power supply from the Rad-67. Note: Use and store the Rad-67 in accordance with specifications. See the Specifications section in this manual.

Performance Warnings and Cautions WARNING: Rad-67 is intended for spot-check monitoring only, no physiological alarms are provided. WARNING: Rad-67 should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: Do not utilize SpHb spot-check measurements as the sole basis for clinical decisions on blood transfusions. The SpHb spot-check accuracy range does not include values below 8 g/dL, which may be important for determining the need for transfusions. WARNING: If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check Rad-67 for proper functioning. WARNING: SpHb is not intended for use in pediatrics, pregnant patients, and patients with renal disease. WARNING: Variation in hemoglobin measurements may be profound and may be affected by sample type, body positioning, as well as other physiological conditions. Any results exhibiting inconsistency with the patient's clinical status should be repeated and/or supplemented with additional data. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition. WARNING: Rad-67 should not be used as a replacement or substitute for ECG-based arrhythmia analysis. WARNING: Rad-67 may be used during defibrillation. This may affect the accuracy or availability of the parameters and measurements. WARNING: Rad-67 may be used during electrocautery. This may affect the accuracy or availability of the parameters and measurements. WARNING: Properly apply sensors according to sensor's directions for use. Misapplied sensor or sensors that become partially dislodged may cause no or incorrect readings. WARNING: Select a well perfused site for monitoring, very low perfusion at the monitored site may result in no or incorrect readings. WARNING: Do not use Rad-67 on patients that have been injected with dyes or any substance containing dyes, the change in usual blood pigmentation may cause no or incorrect readings. WARNING: Displayed parameter(s) may not be accurate when a low SIQ message is provided. Clinicians should consider additional information to supplement values to completely understand the patient’s condition. WARNING: If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. www.masimo.com

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WARNING: Optical, pleth-based measurements (e.g. SpO2 and SpHb) can be affected by the following: 

Improper sensor application or use of use of incorrect sensor.

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Blood pressure cuff applied to the same arm as the sensor site.

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Intravascular dyes such as indocyanine green or methylene blue.

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Venous congestion.

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Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position).

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Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.).

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Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.

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Moisture, birthmarks, skin discoloration, nail aberration, deformed fingers, or foreign objects in the light path.

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Elevated levels of bilirubin.

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Physiological conditions that can significantly shift the oxygen disassociation curve.

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A physiological condition that may effect vasomotor tone or changes in vasomotor tone.

WARNING: Inaccurate SpO2 readings may be caused by: 

Elevated levels of COHb and/or MetHb.

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Severe anemia.

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Extremely low arterial perfusion.

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Excessive induced motion.

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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias).

WARNING: Inaccurate SpHb readings may be caused by: 

Low arterial perfusion.

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Motion induced artifact.

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Low arterial oxygen saturation levels.

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Elevated COHb and/or MetHb levels.

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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias).

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Severe anemia.

CAUTION: If using Rad-67 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 device might read zero for the duration of the active irradiation period.

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Rad-67

Safety Information, Warnings and Cautions

CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy. CAUTION: High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor. CAUTION: To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate measurements. CAUTION: When using a compatible sensor, ensure the gender has been entered correctly. Entering an incorrect gender may affect measurement performance of the device. CAUTION: If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Rad-67. CAUTION: Do not place the Rad-67 near electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Rad-67 promptly after a Low Battery alarm may result in the device shutting down. CAUTION: Do not connect the AC power supply to an electrical outlet controlled by a wall switch or dimmer. CAUTION: In order to establish and maintain Rad-67’s minimum Quality of Service, the following network specifications should be met before and after installation: 

Wired Network Connection During Ping Test, passing result if: a. At least 98% of packets have latency ≤ 30 milliseconds, and b. No more than 2 % packets loss.

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Wireless Network Connection During Ping Test, passing result if: a. At least 98% of packets have latency ≤ 100 milliseconds, b. No more than 2 % packets loss, and c. Primary access point signal strength at least -67 dBm.

CAUTION: The wireless quality of services may be influenced by the presence of other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID, MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices, consideration should be taken to maximize separation distances and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength. CAUTION: Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently displayed while monitoring consecutive patients after completing the low SIQ troubleshooting steps listed in the troubleshooting section.

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Rad-67

Safety Information, Warnings and Cautions

Note: Cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor Directions for Use for the specified duration of patient monitoring time. Note: Physiological conditions that result in loss of pulsatile signal may result in no SpO 2 or SpHb readings. Note: Rad-67 is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication. Note: Always charge Rad-67 when it is not in use to ensure that the battery remains fully charged. Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the Battery Module. Note: A functional tester cannot be used to assess the accuracy of Rad-67. Note: When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be compromised. If the Rad-67 is in this setting and the sensor becomes dislodged from the patient, the potential for false readings may occur due to environmental "noise" such as light, vibration, and excessive air movement. Note: Additional information specific to the Masimo sensors compatible with Rad-67, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU).

Cleaning and Service Warnings and Cautions WARNING: Do not attempt to remanufacture, recondition or recycle the Rad-67 as these processes may damage the electrical components, potentially leading to patient harm. WARNING: To avoid electric shock, do not attempt to replace or remove the Battery from the Rad-67. Service of Rad-67 should be done by qualified personnel only. CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the Rad-67 for servicing. CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the display. CAUTION: To avoid permanent damage to the Rad-67, do not use undiluted bleach (5% 5.25% sodium hypochlorite) or any other cleaning solution not recommended. CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Rad-67. These substances affect the device’s materials and device failure can result. CAUTION: Do not submerge the Rad-67 in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device. CAUTION: To prevent damage, do not soak or immerse Rad-67 in any liquid solution.

Compliance Warnings and Cautions WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. www.masimo.com 15 Masimo

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WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. WARNING: Per RSS-Gen, Section 8.4 This device complies with Industry Canada licenseexempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Per RSS-Gen, Radio apparatus shall comply with the requirements to include required notices or statements to the user of equipment with each unit of equipment model offered for sale. CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories. CAUTION: Device contains an internal battery. Dispose of the battery according to required country or regional requirements. Note: Use Rad-67 in accordance with the Environmental Specifications section in the Operator's Manual. Note: This device complies with part 15 of the FCC Rules. 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: 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.

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Increase the separation between the equipment and receiver.

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Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

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Consult the dealer or an experienced radio/TV technician for help.

Note: This equipment has been tested and found to comply with the Class B limits for medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments. Note: In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and TV reception. The user is cautioned that changes and modifications made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment. Note: To satisfy RF exposure requirements, this device and its antenna must not be colocated or operating in conjunction with any other antenna or transmitter. Note: This Class B digital apparatus complies with Canadian ICES-003. www.masimo.com

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Note: This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

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Chapter 1: Technology Overview The following chapter contains general descriptions about parameters, measurements, and the technology used by Masimo products.

Signal Extraction Technology® (SET®) Masimo Signal Extraction Technology's signal processing differs from that of conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the venous blood also moves, causing conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET® pulse oximetry utilizes parallel engines and adaptive filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET® signal processing algorithm, Discrete Saturation Transform® (DST®), in parallel with Fast Saturation Transform (FST®), reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.

Masimo rainbow SET® Parallel Engines This figure is for conceptual purposes only.

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Chapter 1: Technology Overview

Masimo SET® DST This figure is for conceptual purposes only.

General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: 1. 2.

Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry). The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

Successful Monitoring for SpO2, PR and Pi Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is a relative term, experience will provide a good feeling for changes that are artifactual or physiological and the speed, timing, and behavior of each. The stability of the readings over time is affected by the averaging time being used. The longer the averaging time, the more stable the readings tend to become. This is due to a dampened response as the signal is averaged over a longer period of time than during shorter averaging times. However, longer averaging times delay the response of the oximeter and reduce the measured variations of SpO2 and pulse rate.

Functional Oxygen Saturation (SpO2) The Rad-67 is calibrated to measure and display functional oxygen saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. Note: Dyshemoglobins are not capable of transporting oxygen, but are recognized as oxygenated hemoglobins by conventional pulse oximetry.

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Rad-67

Chapter 1: Technology Overview

General Description for Pulse Rate (PR) Pulse rate (PR), measured in beats per minute (BPM) is based on the optical detection of peripheral flow pulse.

General Description for Perfusion Index (Pi) The Perfusion Index (Pi) is the ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue. Pi thus represents a noninvasive measure of peripheral perfusion that can be continuously and noninvasively obtained from a pulse oximeter.

Signal IQ The Signal IQ provides an indicator of the assessment of the confidence in the displayed SpO2 value. The SpO2 SIQ can also be used to identify the occurrence of a patient’s pulse. With motion, the plethysmographic waveform is often distorted and may be obscured by noise artifact. Shown as a vertical line, the SpO2 SIQ coincides with the peak of an arterial pulsation. Even with a plethysmographic waveform obscured by artifact, the Signal IQ identifies the timing that the algorithms have determined for the arterial pulsation. The pulse tone (when enabled) coincides with the vertical line of the SpO2 SIQ. The height of the vertical line of the SpO2 SIQ provides an assessment of the confidence in the measurement displayed. A high vertical bar indicates higher confidence in the measurement. A small vertical bar indicates lower confidence in the displayed measurement. When the Signal IQ is very low, this suggests that the accuracy of the displayed measurement may be compromised. See About the Status Bar on page 34.

rainbow Pulse CO-Oximetry Technology® rainbow Pulse CO-Oximetry technology is governed by the following principles: 1.

2.

Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry). The amount of arterial blood in tissue changes with pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

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Rad-67

Chapter 1: Technology Overview

Rad-67 uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma. Rad-67 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a diode (detector). Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25 mW. The detector receives the light, converts it into an electronic signal and sends it to the Rad-67 for calculation. 1. 2.

Light Emitting Diodes (LEDs) (7 + wavelengths) Detector

Once Rad-67 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient’s functional oxygen saturation (SpO2 [%]), total hemoglobin concentration (SpHb [g/dL]) and pulse rate (PR). The SpHb measurements rely on a multiwavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin and the concentration of total hemoglobin in arterial blood. Maximum skinsensor interface temperature was tested to be less than 41º C (106º F) in a minimum ambient temperature of 35º C (95º F). The tests were conducted with sensors operating at reasonable worst case power.

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Chapter 1: Technology Overview

Pulse CO-Oximetry vs. Drawn Whole Blood Measurements When SpO2 and SpHb measurements obtained from the Rad-67 (noninvasive) are compared to drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry methods, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO2 and SpHb measurements of the Rad-67. Any comparisons should be simultaneous, meaning the measurement on the device should be noted at the exact time that blood is drawn. In the case of SpO2, different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (pO 2) and saturation, such as: pH,temperature, the partial pressure of carbon dioxide (pCO2), 2,3-DPG, and fetal hemoglobin. In the case of SpHb, variation in hemoglobin measurements may be profound and may be affected by sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patient's clinical status should be repeated and/or supplemented with additional test data. As with most hemoglobin tests, a laboratory blood sample should be analyzed prior to clinical decision making. High levels of bilirubin may cause erroneous SpO2 and SpHb readings. As blood samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a meaningful comparison can only be achieved if the oxygen saturation (SaO2), levels of carboxyhemoglobin (COHb), and MetHb of the patient are stable and not changing over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory CO-Oximetry measurements of SpO2 and SpHb may vary with the rapid administration of fluids and in procedures such as dialysis. Additionally, drawn whole blood testing can be affected by sample handling methods and time elapsed between blood draw and sample testing. Measurements with Low Signal IQ should not be compared to laboratory measurements.

General Description for Total Hemoglobin (SpHb) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make its SpHb measurement.

Successful Monitoring for SpHb A stable SpHb reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. See Safety Information, Warnings and Cautions on page 11 and Troubleshooting Measurements on page 67.

General Description for Total Arterial Oxygen Content (CaO2) Oxygen (O2) is carried in the blood in two forms, either dissolved in plasma or combined with hemoglobin. The amount of oxygen in the arterial blood is termed the oxygen content www.masimo.com

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Chapter 1: Technology Overview

(CaO2) and is measured in units of ml O2/dL blood. One gram of hemoglobin (Hb) can carry 1.34 ml of oxygen, whereas 100 ml of blood plasma may carry approximately 0.3 ml of oxygen*. The oxygen content is determined mathematically as: CaO2 = 1.34 (ml O2/g) x Hb (g/dL) x HbO2 + PaO2 (mmHg) x 0.003 (ml O2/dL/mmHg) Where HbO2 is the fractional arterial oxygen saturation and PaO2 is the partial pressure of arterial oxygen. For typical PaO2 values, the second part of the above equation is approximately 0.3 ml O2/dL based on PaO2 being approximately 100 mmHg. Furthermore, for typical carboxyhemoglobin and methemoglobin levels, the functional saturation (SpO 2) as measured by a pulse oximeter is given by: SpO2 = 1.02 x HbO2 *Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second Edition. New York: Lippincott Williams & Wilkins, 1999.

SpHb Measurements During Patient Motion The Rad-67 displays measurements of SpHb during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable during excessive motion. In this case, the measurement value for SpHb displays as dashes (---) and a message (Low SpHb SIQ) displays to alert the clinician that the device does not have confidence in the value due to poor signal quality caused by excessive motion or other signal interference.

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