Radical-7 Touch Pulse CO-Oximeter Operators Manual

The Radical-7 operating instructions provide the necessary information for proper operation of all models of the Radical-7 Pulse CO-Oximeter system. There may be information provided in this manual that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of the Radical-7 are prerequisites for its proper use. Do not operate the Radical-7 without completely reading and understanding the instructions in this manual. NOTICE: Purchase or possession of this instrument does not carry any express or implied license to use this instrument with replacement parts which would, alone or in combination with this instrument, fall within the scope of one of the patents relating to this instrument. Caution Federal law restricts this device to sale by or on the order of a physician. Wireless Radio FCC ID: VKF-RAD7CA, IC: 7362A-RAD7CA 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 Medical electrical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1 Patents: www.masimo.com/patents.htm © 2012 Masimo Corporation ®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, Masimo®, Pulse Oximeter®, PVI®, rainbow®, SatShare®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®, SpMet® are federally registered trademarks of Masimo Corporation. Adaptive Threshold Alarm™, In Vivo Adjustment™, Pleth Variability Index™, Radical-7™, Rainbow Acoustic Monitoring™, rainbow Resposable™, RDS™, RRa™, RRp™,SafetyNet™, SpOC™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. The use of the trademarks PATIENT SAFETYNET and PSN is under license from University HealthSystem Consortium.

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Contents About this Manual -------------------------------------------------------------------------------------------7 Product Description, Indications for Use, Contraindications, and Features ---------------------- 9 Product Description ------------------------------------------------------------------------------------- 9 Indications for Use-------------------------------------------------------------------------------------10 Contraindications --------------------------------------------------------------------------------------10 Safety Information, Warnings, and Cautions ---------------------------------------------------------- 11 Parameter Related Safety Information, Warnings, and Cautions ------------------------------ 11 Device Related Safety Information, Warnings, and Cautions----------------------------------- 14 Electrical Safety Information, Warnings, and Cautions ----------------------------------------- 17 Alarm Related Safety Information, Warnings, and Cautions ---------------------------------- 20 Sensor Related Safety Information, Warnings, and Cautions ---------------------------------- 21 Chapter 1: Technology Overview ------------------------------------------------------------------------23 Signal Extraction Technology (SET) ----------------------------------------------------------------23 rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 25 rainbow Acoustic Monitoring (RAM) Technology -------------------------------------------------29 Chapter 2: Radical-7 Descriptions --------------------------------------------------------------------- 33 General System Description ------------------------------------------------------------------------- 33 Functionality of the Radical-7------------------------------------------------------------------------34 Handheld ----------------------------------------------------------------------------------------------- 35 Standalone ---------------------------------------------------------------------------------------------- 37 Monitor Interface With SatShare ------------------------------------------------------------------- 40 Chapter 3: Setup ------------------------------------------------------------------------------------------- 41 Unpacking and Inspection --------------------------------------------------------------------------- 41 Docking Station Power Requirements -------------------------------------------------------------- 41 Setting Up the Docking Station --------------------------------------------------------------------- 41 Initial Battery Charging ------------------------------------------------------------------------------- 42 Setting Up for Philips, Agilent, or HP VueLink ---------------------------------------------------- 42 Setting Up for SpaceLabs Flexport ------------------------------------------------------------------43 Setting Up and Using SatShare --------------------------------------------------------------------- 44 Chapter 4: Operation -------------------------------------------------------------------------------------- 45 Using the Touchscreen and Buttons ---------------------------------------------------------------- 45 www.masimo.com

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Using Screen Lock ------------------------------------------------------------------------------------- 46 Using the Home Button ------------------------------------------------------------------------------ 46 Navigating the Radical-7 ----------------------------------------------------------------------------- 47 About the Display View ------------------------------------------------------------------------------- 48 Sensitivity Modes Overview -------------------------------------------------------------------------- 55 Changing Sensitivity Modes ------------------------------------------------------------------------- 56 Accessing the Main Menu ---------------------------------------------------------------------------- 57 Navigating the Main Menu--------------------------------------------------------------------------- 57 Parameter Settings ------------------------------------------------------------------------------------ 59 Sounds --------------------------------------------------------------------------------------------------- 74 Device Settings ----------------------------------------------------------------------------------------- 75 Trends ---------------------------------------------------------------------------------------------------- 81 About----------------------------------------------------------------------------------------------------- 91 Chapter 5: Profiles ----------------------------------------------------------------------------------------- 93 Profiles Overview --------------------------------------------------------------------------------------- 93 Changing Profiles -------------------------------------------------------------------------------------- 94 Replacing Factory Default Settings for Adult and Neo Profiles -------------------------------- 97 Powering Off the Radical-7 --------------------------------------------------------------------------- 98 Chapter 6: Alarms and Messages ----------------------------------------------------------------------- 99 About Alarms ------------------------------------------------------------------------------------------- 99 Silencing the Alarms ---------------------------------------------------------------------------------- 99 Adaptive Threshold Alarm (ATA) Feature ------------------------------------------------------- 101 3D Alarms --------------------------------------------------------------------------------------------- 102 Messages ---------------------------------------------------------------------------------------------- 104 Chapter 7: Troubleshooting ----------------------------------------------------------------------------- 111 Troubleshooting Measurements-------------------------------------------------------------------- 111 Troubleshooting the Radical-7 --------------------------------------------------------------------- 113 Chapter 8: Specifications ------------------------------------------------------------------------------- 115 Measurement Range --------------------------------------------------------------------------------- 115 Accuracy ------------------------------------------------------------------------------------------------ 115 Resolution ---------------------------------------------------------------------------------------------- 117 Electrical------------------------------------------------------------------------------------------------ 117 Environmental----------------------------------------------------------------------------------------- 118 Physical Characteristics ----------------------------------------------------------------------------- 118 www.masimo.com

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Trending ----------------------------------------------------------------------------------------------- 118 Alarms-------------------------------------------------------------------------------------------------- 119 Display Indicators ------------------------------------------------------------------------------------ 120 Compliance---------------------------------------------------------------------------------------------121 Output Interface -------------------------------------------------------------------------------------- 122 Wireless Radio (If Installed) ----------------------------------------------------------------------- 122 Serial Interface Specifications --------------------------------------------------------------------- 122 Serial Interface Setup ------------------------------------------------------------------------------- 123 Analog Output and Nurse Call Specifications --------------------------------------------------- 124 Symbols ------------------------------------------------------------------------------------------------ 126 Country Codes (FCC and EU) ------------------------------------------------------------------------127 Citations ----------------------------------------------------------------------------------------------- 129 Chapter 9: Service and Maintenance----------------------------------------------------------------- 131 Cleaning ----------------------------------------------------------------------------------------------- 131 Battery Operation and Maintenance ------------------------------------------------------------- 131 Performance Verification --------------------------------------------------------------------------- 134 Repair Policy ------------------------------------------------------------------------------------------ 136 Return Procedure ------------------------------------------------------------------------------------- 136 Contacting Masimo ---------------------------------------------------------------------------------- 137 Appendix: Best Practices for Comparisons to Reference Measurements----------------------- 139 Best Practices Checklist for Continuous SpHb Comparisons --------------------------------- 139 Best Practices Checklist for SpCO Comparisons ------------------------------------------------ 142 Best Practices Checklist for Acoustic Respiration Rate Comparisons ----------------------- 144 Index ------------------------------------------------------------------------------------------------------- 149

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About this Manual This manual explains how to set up and use the Radical-7 Pulse CO-Oximeter. Important safety information relating to general use of the Radical-7 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 affect, death) to the patient or user. The following is an example of a warning: Warning This is a sample 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 instrument or damage to other property. The following is an example of a caution: Caution This is a sample of caution statement. A note is given when additional general information is applicable. The following is an example of a note: Note: This is a sample of a note.

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Product Description, Indications for Use, Contraindications, and Features The following chapter contains the Radical-7 product description, key features and benefits, indications for use, contraindications, and safety information, including cautions, warnings, and notes.

Product Description The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI), along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), Pleth Variability Index (PVI), Acoustic Respiration Rate (RRa), and Pleth Respiration Rate (RRp). The Radical-7 can be used as either a Handheld or a Standalone monitor. The Radical-7 features a touchscreen Liquid Crystal Display (LCD) that continuously displays numeric values for all parameters. The Radical-7 provides graphical displays for plethysmographic waveform, respiratory waveform, Signal Identification and Quality Indicator (Signal IQ). The Radical-7 can also be used to interface with a multi-parameter patient monitor to send Masimo SET pulse oximetry information to that monitor for display. The Radical-7 has an embedded 802.11 wireless radio that can be used for connectivity.

Key Features The following features are available for the Radical-7. Some features are optional: 

Masimo SET is clinically proven to satisfy all sensitivity and specificity requirements for pulse oximeter technology.

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Rainbow technology uses 7+ wavelengths of light to continuously and noninvasively measure carboxyhemoglobin (SpCO), methemoglobin (SpMet), and total hemoglobin (SpHb), as well as providing a more reliable probe-off detection.

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Total oxygen content (SpOC) provides a calculated measurement of the amount of oxygen in arterial blood, which may provide useful information about oxygen both dissolved in plasma and combined with hemoglobin.

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Perfusion Index (PI) with trending capability indicates arterial pulse signal strength and may be used as a diagnostic tool during low perfusion.

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Pleth Variability Index (PVI) may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions. [The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe malposition and patient motion.]



Respiration rate can be determined by the acoustic (RRa) or plethysmographic waveform (RRp).

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Product Description, Indications for Use, Contraindications, and Features

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Signal IQ waveform for signal identification and quality indication during excessive motion and low signal to noise situations.

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FastSat tracks rapid changes in arterial O2.

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Variable pitch provides tonal variance for every 1% change in saturation.

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SatShare interface allows transfer of SpO2 and pulse rate to an existing multi-parameter monitor and allows for the reading of SpCO, SpMet, SpHb, and SpOC on adjacent Radical-7 monitor.

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Automatic screen rotation provides upright display for vertical or horizontal monitor positioning.

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Multi-gesture touchscreen interface.

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Detachable portable Handheld for patient transport.

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Remote alarm interface.

Indications for Use The Masimo Radical-7 and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 and accessories have been validated and are indicated 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 hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo rainbow SET Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display of those devices.

Contraindications The Radical-7 is not intended for use as an apnea monitor.

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Safety Information, Warnings, and Cautions The following section lists warnings, caution, notes, and safety information. The Radical-7 is designed to minimize the possibility of hazards from errors in the software program by following sound Engineering Design Processes, Risk Analysis and Software Validation. The Radical-7 is to be operated by qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. Always use the Radical-7 precisely in accordance with the directions in this manual, including finger selection, finger alignment in the sensor, and subject behavior during testing. Failure to follow all of the directions in this manual could lead to inaccurate measurements. Caution For SpHb, the Radical-7 should be considered an early warning device. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition. Caution Variation in hemoglobin measurements may be profound and may be affected by sample type, body positioning, as well as other physiological conditions. As with most hemoglobin tests, Radical-7 test results should be scrutinized in light of a specific patient’s condition. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data.

Parameter Related Safety Information, Warnings, and Cautions This section contains parameter related safety information. Warning Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. Warning SpO2, SpCO, SpMet, and SpHb are empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). www.masimo.com

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Safety Information, Warnings, and Cautions Warning The Radical-7 cannot measure elevated levels of COHb or MetHb. Warning Inaccurate SpO2 readings may be caused by: 

Elevated levels of COHb and MetHb 

For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level of increase is approximately equal to the amount of COHb that is present.



Note: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.



For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.

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Intravascular dyes such as indocyanine green or methylene blue

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

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Elevated levels of bilirubin

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Severe anemia

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Low arterial perfusion

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Motion artifact

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Safety Information, Warnings, and Cautions Warning Inaccurate SpHb and SpOC readings may be caused by: 

Intravascular dyes such as indocyanine green or methylene blue

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

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Elevated levels of bilirubin

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Low arterial perfusion

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Motion artifact

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Low arterial oxygen saturation levels

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Elevated carboxyhemoglobin levels

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Elevated methemoglobin levels

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Difference between patient's finger skin and finger core temperature

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Hemoglobin synthesis disorders

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Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc.

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Vasospastic disease such as Raynaud's

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Elevated altitude

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Peripheral vascular disease

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Liver disease

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EMI radiation interference

Warning Inaccurate SpCO and SpMet readings can be caused by: 

Intravascular dyes such as indocyanine green or methylene blue

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Abnormal hemoglobin levels

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Low arterial perfusion

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Low arterial oxygen saturation levels including altitude induced hypoxemia

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Elevated total bilirubin levels

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Motion artifact

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SpCO readings may not be provided if SpO2 readings are less than 90%

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SpCO readings may not be provided if SpMet readings are greater than 2%

Inaccurate SpCO readings can be caused by: 

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Levels of methemoglobin approximately 1.5% or above

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Safety Information, Warnings, and Cautions Warning Inaccurate respiration rate measurements may be caused by: 

Low arterial perfusion



Motion artifact

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Low arterial oxygen saturation

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Excessive ambient or environmental noise



Improper sensor placement

Caution If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to completely understand the patient’s condition. Caution Confirm offset values(s) periodically as the difference between the displayed parameter value and the laboratory reference value may vary over time. Caution Do not use In Vivo Adjustment if the monitor displays a Low SpHb SIQ message. 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 Changing the SpHb Cal, the date and time of the system clock, or the trend period clears the data in the trend memory. Caution Excessive ambient noise may affect the accuracy of the respiration rate reading from the Acoustic Respiration Sensor.

When monitoring acoustic respiration, Masimo recommends minimally monitoring both oxygenation (SpO2) and respiration (RRa).

Device Related Safety Information, Warnings, and Cautions This section contains device related safety information.

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Radical-7

Safety Information, Warnings, and Cautions Warning Explosion hazard: Do not use the Radical-7 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. Warning Do not use the Radical-7 or sensor during magnetic resonance imaging (MRI) scanning. Warning Do not place the Radical-7 or accessories in any position that might cause it to fall on the patient. Warning During SatShare operation, do not use the plethysmographic waveform display on the multi-parameter monitor for diagnostic purposes. Instead, use the plethysmographic waveform displayed on the Radical-7 screen. Warning Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The Radical-7 should not be used as a replacement or substitute for ECG-based arrhythmia analysis. Warning The Radical-7 can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds. Warning Do not place containers with liquids on or near the Radical-7. Liquids spilled on the instrument may cause it to perform inaccurately or fail. Warning EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause error or incorrect measurements on the Radical-7. Warning If the Radical-7 fails any part of the setup procedures or leakage spot check, remove the instrument from operation until qualified service personnel have corrected the situation. Warning A functional tester cannot be used to assess the accuracy of the Radical-7.

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Radical-7

Safety Information, Warnings, and Cautions Warning Do not autoclave, pressure sterilize, or gas sterilize the Radical-7. Warning 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 panel. Warning Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Radical-7. These substances affect the device’s materials and instrument failure can result. Warning An operator may only perform maintenance procedures specifically described in the manual. Refer servicing to qualified service personnel trained in the repair of this equipment. Warning SatShare signals are ideal simulated waveforms corresponding to the calculated saturation and pulse rate values and do contain all of the information contained in physiological waveforms. The multi-parameter patient monitor decodes these signals into saturation and pulse rate values. Warning Simultaneous use of SatShare and serial port is not supported. Caution Do not place the Radical-7 where the controls can be changed by the patient. Caution Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories.

Only SpO2 and pulse rate can be displayed on the multi-parameter monitor with Flexport. If the Radical Docking Station is compatible with SafetyNet, Vuelink is not supported. Use the Radical-7 in accordance with Environmental Specifications section in of this manual.

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Radical-7

Safety Information, Warnings, and Cautions

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. Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) 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 FDA, or in any manner inconsistent with the instructions for use or labeling. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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. 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.



Increase the separation between the equipment and receiver.



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



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

This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This Class B digital apparatus complies with Canadian ICES-003.

Electrical Safety Information, Warnings, and Cautions This section contains electrical related safety information. Warning Fire Hazard: To protect against fire hazard, replace only with fuses of same type, current rating, and voltage rating.

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Radical-7

Safety Information, Warnings, and Cautions Caution Do not place the Radical-7 on electrical equipment that may affect the instrument, preventing it from working properly. Caution Dispose of used batteries according to required country or regional instructions. Caution Risk of explosion if battery is replaced with an incorrect type. Replace with Masimo supplied parts only. Caution At Low Battery, connect the Radical-7 to AC power to prevent loss of power. Caution Do not incinerate battery. Caution Electric shock hazard: Do not open the Radical-7 cover except to replace the battery or batteries. Caution To protect against injury from electric shock, follow the directions below: 

Avoid placing the device on surfaces with visible liquid spills.



Do not soak or immerse the device in liquids.



Use cleaning solutions sparingly.

Caution Electrical shock and flammability hazard: Before cleaning the Radical-7, always turn it off and disconnect the power cord from the AC power supply. Caution Do not under any circumstances remove the grounding conductor from the power plug. Caution Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged.

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Radical-7

Safety Information, Warnings, and Cautions Caution To ensure patient electrical isolation, connect only to other equipment with electrically isolated circuits. Caution Do not connect to an electrical outlet controlled by a wall switch or dimmer.

All external instrument connections to the Analog Output/Nurse Call connector must be IEC-60950 compliant. It is recommended that the Radical-7 Handheld is docked to the Docking Station that is attached to an AC power source when it is not in use to ensure that the battery remains fully charged. External instrument connections to the SatShare port must be IEC-60601-1 compliant. Only use a SatShare cable that has a ferrite bead installed. Use the power cord as the means to disconnect the instrument from the main power supply. If the Radical-7 Handheld has not been used or charged within seven (7) days or more, then recharge the battery prior to use. The instrument must be configured to match your local power line frequency to allow for the cancelation of noise introduced by fluorescent lights and other sources. If there is any doubt about the integrity of the protective earth conductor arrangement, operate the Radical-7 on internal battery power until the AC power supply protective conductor is fully functional. To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize by irradiation, steam, autoclave or any method other than ethylene oxide as indicated. Only SpO2 and pulse rate can be displayed on the multi-parameter monitor with SatShare. The battery should be installed and/or removed from the Radical-7 by qualified personnel only. All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the battery. All external device connections to the RS-232 serial port must be IEC-60950 compliant. The Docking Station battery should be installed and/or removed from the Docking Station only by qualified personnel. www.masimo.com

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Radical-7

Safety Information, Warnings, and Cautions

To conserve battery power, keep the frequency of the audible alarms to a minimum and the volume to a minimum. To conserve battery power, keep the back-lit LCD screen at minimum illumination. When using the SatShare feature, to conserve battery power, always keep the Radical-7 on AC line power.

Alarm Related Safety Information, Warnings, and Cautions This section contains alarm related safety information. Caution For home use, ensure that the Radical-7 alarm can be heard from other rooms in the house, especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios are operating. Caution Do not place the Radical-7 against a surface that may cause the alarm to be muffled. Caution To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time the Radical-7 is used. Caution The Nurse Call feature is disabled when the Audible Alarms are silenced and Nurse Call setting is set to Alarms. Caution When the Radical-7 is placed in All Mute, the patient alarms will not audibly sound on the Radical-7 or the SafetyNet. The SafetyNet View will display a visual alarm. Caution During SatShare operation, the audible alarms may be muted on the Radical-7. When the audible alarm is muted (indicated by a bell with a slash through it) on the Radical-7, use the multi-parameter monitor for audible alarm indication.

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Radical-7

Safety Information, Warnings, and Cautions Caution If an alarm condition occurs while the Alarm Silence period is set to All Mute, the only alarm indications will be visual display and symbols related to alarm condition. No alarm will sound.

The Desat Index alarm is intended as an adjunct rather than in place of the Low Saturation alarm.

Sensor Related Safety Information, Warnings, and Cautions This section contains sensor related safety information. Warning As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Warning Always remove the sensor from the patient and completely disconnect the patient from the Radical-7 before bathing the patient. Caution If using the Radical-7 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 instrument might read zero for the duration of the active irradiation period.

Do not loop the sensor cable into a tight coil or wrap around the device, as this can damage the sensor cable. Patient Safety - If a sensor is damaged in any way, discontinue use immediately. Failure to apply the sensor properly may lead to incorrect measurements. Additional information specific to the Masimo sensors compatible with Radical-7, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU). Do not expose the Masimo sensors used with Radical-7 to moisture, liquids or a humid environment, as this may make the sensor perform inaccurately or fail. High-intensity extreme lights (including pulsating strobe lights and direct sunlight) directed on the sensor, may not allow the Radical-7 to obtain readings.

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Radical-7

Safety Information, Warnings, and Cautions

When using the Maximum Sensitivity setting, performance of the Sensor Off detection may be compromised. If the Radical-7 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.

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