Masimo RAD7CA User Manual

Radical-7

Operator's Manual

Caution

Federal law restricts this device to sale by or on the order of a physician.

Masimo Corporation 40 Parker Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com

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

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.

Wireless Radio FCC ID: VKF-RAD7CA, IC: 7362A-RAD7CA

EU authorized representative for Masimo Corporation:

MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

Patents: www.masimo.com/patents.htm

®, 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 ------------------------------------ 15 Electrical Safety Information, Warnings, and Cautions ------------------------------------------- 18 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 -------------------------------------------------------------- 26 rainbow Acoustic Monitoring (RAM) Technology--------------------------------------------------- 30

Chapter 2: Radical-7 Descriptions ------------------------------------------------------------------------- 33

General System Description ----------------------------------------------------------------------------- 33 Functionality of the Radical-7 --------------------------------------------------------------------------- 34

Handheld ---------------------------------------------------------------------------------------------------- 35 Standalone -------------------------------------------------------------------------------------------------- 37 Monitor Interface ------------------------------------------------------------------------------------------ 40

Chapter 3: Setup ----------------------------------------------------------------------------------------------- 41

Unpacking and Inspection ------------------------------------------------------------------------------- 41 Docking Station Power Requirements----------------------------------------------------------------- 41 Setting Up the Docking Station ------------------------------------------------------------------------ 42 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

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Radical-7 Contents

Using Screenlock ------------------------------------------------------------------------------------------- 46 Using the Home Button ---------------------------------------------------------------------------------- 46 Navigating the Radical-7 --------------------------------------------------------------------------------- 47

About the Display View ----------------------------------------------------------------------------------- 48 Accessing the Main Menu -------------------------------------------------------------------------------- 55 Navigating the Main Menu ------------------------------------------------------------------------------ 56 Parameter Settings ---------------------------------------------------------------------------------------- 58 Sounds -------------------------------------------------------------------------------------------------------- 73 Device Settings --------------------------------------------------------------------------------------------- 74 Trends -------------------------------------------------------------------------------------------------------- 81 About --------------------------------------------------------------------------------------------------------- 87

Chapter 5: Configurations ----------------------------------------------------------------------------------- 89

About Profiles and Default Settings ------------------------------------------------------------------- 89 Changing Profiles Settings ----------------------------------------------------------------------------- 90 About Patient Types --------------------------------------------------------------------------------------- 92 Powering Off the Radical-7------------------------------------------------------------------------------- 93

Chapter 6: Alarms and Messages -------------------------------------------------------------------------- 95

About Alarms ----------------------------------------------------------------------------------------------- 95

Silencing the Alarms -------------------------------------------------------------------------------------- 95 Adaptive Threshold Alarm (ATA) Feature ------------------------------------------------------------ 97 3D Alarms---------------------------------------------------------------------------------------------------- 98 Messages --------------------------------------------------------------------------------------------------- 100

Chapter 7: Troubleshooting---------------------------------------------------------------------------------107

Troubleshooting Measurements -----------------------------------------------------------------------107 Troubleshooting the Radical-7 ------------------------------------------------------------------------ 109

Chapter 8: Specifications ----------------------------------------------------------------------------------- 111

Performance ------------------------------------------------------------------------------------------------ 111 Accuracy ----------------------------------------------------------------------------------------------------- 111 Resolution -------------------------------------------------------------------------------------------------- 113 Electrical ---------------------------------------------------------------------------------------------------- 113 Environmental --------------------------------------------------------------------------------------------- 114 Physical Characteristics --------------------------------------------------------------------------------- 114 Trending----------------------------------------------------------------------------------------------------- 114 Alarms ------------------------------------------------------------------------------------------------------- 115

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Radical-7 Contents

Display Indicators----------------------------------------------------------------------------------------- 116 Compliance ------------------------------------------------------------------------------------------------- 117 Output Interface ------------------------------------------------------------------------------------------ 118

Wireless Radio (If Installed)---------------------------------------------------------------------------- 118 Serial Interface Specifications ------------------------------------------------------------------------- 118 Serial Interface Setup ------------------------------------------------------------------------------------ 119 Analog Output and Nurse Call Specifications ----------------------------------------------------- 120 Symbols ----------------------------------------------------------------------------------------------------- 122 ISO Country Codes (FCC and EU) ----------------------------------------------------------------------123 Citations ---------------------------------------------------------------------------------------------------- 125

Chapter 9: Service and Maintenance -------------------------------------------------------------------- 127

Cleaning----------------------------------------------------------------------------------------------------- 127 Battery Operation and Maintenance ----------------------------------------------------------------- 127 Performance Verification------------------------------------------------------------------------------- 130 Repair Policy -----------------------------------------------------------------------------------------------132 Return Procedure -----------------------------------------------------------------------------------------132 Contacting Masimo-------------------------------------------------------------------------------------- 133

Appendix: Best Practices for Comparisons to Reference Measurements ------------------------ 137

Best Practices Checklist for Continuous SpHb Comparisons ----------------------------------- 137 Best Practices Checklist for SpCO Comparisons -------------------------------------------------- 140 Best Practices Checklist for Acoustic Respiration Rate Comparisons------------------------- 142

Index ------------------------------------------------------------------------------------------------------------- 145

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Warning

This is a sample of a warning statement.

Caution

This is a sample of caution statement.

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:

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:

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, and perfusion index (PI), along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO), 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.

 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.

 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.

 Perfusion Index (PI) with trending capability indicates arterial pulse signal

strength and may be used as a diagnostic tool during low perfusion.

 Pleth Variability Index (PVI) may show changes that reflect physiologic factors

such as vascular tone, circulating blood volume, and intrathoracic pressure excursions.

 Respiration rate can be determined by the acoustic (RRa) or plethysmographic

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waveform (RRp)

Radical-7 Product Description, Indications for Use, Contraindications, and Features

 Signal IQ waveform for signal identification and quality indication during

excessive motion and low signal to noise situations.

 FastSat tracks rapid changes in arterial O2.  Variable pitch provides tonal variance for every 1% change in saturation.  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 the monitor.

 Automatic screen rotation provides upright display for vertical or horizontal

monitor positioning.

 Multi-gesture touchscreen interface.  Detachable portable Handheld for patient transport.  Desat Index Alarm may help clinicians to detect an increasing quantity of smaller

desaturations that may precede declining respiratory status.

 Perfusion Index (PI) Delta Alarm alerts clinicians to possible changes in

perfusion, often a reliable indicator of illness severity.

 Advanced Threshold Alarms to dynamically adjust alarm thresholds that are

tailored specifically to the patient.

 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, 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 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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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.

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.

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.

Parameter Related Safety Information, Warnings, and Cautions

This section contains parameter related safety information.

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Radical-7 Safety Information, Warnings, and Cautions

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.

Note: Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.

Note: Inaccurate SpCO and SpMet readings can be caused by:

 Levels of methemoglobin approximately 1.5% or above  Intravascular dyes such as indocyanine green or methylene blue  Abnormal hemoglobin levels  Low arterial perfusion  Low arterial oxygen saturation levels including altitude induced hypoxemia  Elevated total bilirubin levels  Motion artifact  SpCO readings may not be provided if SpO2 readings are less than 90%  SpCO readings may not be provided if SpMet readings are greater than 2%

Note: SpO2, SpCO, SpMet, and SpHb are empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).

Note: The Radical-7 cannot measure elevated levels of COHb or MetHb.

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Radical-7 Safety Information, Warnings, and Cautions

Note: 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.

Note: Inaccurate SpO2 readings may be caused by:

 Intravascular dyes such as indocyanine green or methylene blue  Externally applied coloring and texture such as nail polish, acrylic nails, glitter,

etc.

 Elevated levels of bilirubin  Severe anemia  Low arterial perfusion  Motion artifact

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Radical-7 Safety Information, Warnings, and Cautions

Note: Inaccurate SpHb and SpOC readings may be caused by:

 Intravascular dyes such as indocyanine green or methylene blue  Externally applied coloring and texture such as nail polish, acrylic nails, glitter,

etc.

 Elevated levels of bilirubin  Low arterial perfusion  Motion artifact  Low arterial oxygen saturation levels  Elevated carboxyhemoglobin levels  Elevated methemoglobin levels  Difference between patient's finger skin and finger core temperature  Hemoglobin synthesis disorders  Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,

sickle cell, etc.

 Vasospastic disease such as Raynaud's  Elevated altitude  Peripheral vascular disease  Liver disease  EMI radiation interference

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Radical-7 Safety Information, Warnings, and Cautions

Note: Inaccurate SpHb readings may be caused by:

 Intravascular dyes such as indocyanine green or methylene blue  Externally applied coloring and texture such as nail polish, acrylic nails, glitter,

etc.

sickle cell, etc.

 Vasospastic disease such as Raynaud's  Elevated altitude  Peripheral vascular disease  Liver disease  EMI radiation interference

Note: Inaccurate SpCO and SpMet readings can be caused by:

Note: Only SpO2 and pulse rate can be displayed on the multi-parameter monitor with Flexport.

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 use the Radical-7 during electrocautery.

Warning

Do not use the Radical-7 or sensor during defibrillation.

Warning

Do not place the Radical-7 or accessories in any position that might cause it to fall on the patient.

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.

Caution

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.

Caution

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.

Note: 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.

Note: EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause error or incorrect measurements on the Radical-7.

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Radical-7 Safety Information, Warnings, and Cautions

Note: 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.

Note: A functional tester cannot be used to assess the accuracy of the Radical-7.

Note: Do not autoclave, pressure sterilize, or gas sterilize the Radical-7.

Note: 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.

Note: 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.

Note: 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.

Note: 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.

Note: Simultaneous use of SatShare and serial port is not supported.

Note: 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.

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.

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Radical-7 Safety Information, Warnings, and Cautions

Warning

Fire Hazard: To protect against fire hazard, replace only with fuses of same type, current rating, and voltage rating.

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.

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.

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Radical-7 Safety Information, Warnings, and Cautions

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.

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.

Note: All external instrument connections to the Analog Output/Nurse Call connector must be IEC-60950 compliant.

Note: 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.

Note: External instrument connections to the SatShare port must be IEC-60601-1 compliant.

Note: Only use a SatShare cable that has a ferrite bead installed.

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Radical-7 Safety Information, Warnings, and Cautions

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.

Note: Use the power cord as the means to disconnect the instrument from the main power supply.

Note: If the Radical-7 Handheld has not been used or charged within seven (7) days or more, then recharge the battery prior to use.

Note: 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.

Note: 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.

Note: 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.

Note: Only SpO2 and pulse rate can be displayed on the multi-parameter monitor with SatShare.

Note: The battery should be installed and/or removed from the Radical-7 by qualified personnel only.

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.

Note: All external device connections to the RS-232 serial port must be IEC-60950 compliant.

Note: The Docking Station battery should be installed and/or removed from the Docking Station only by qualified personnel.

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.

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Radical-7 Safety Information, Warnings, and Cautions

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

Alarms are disabled in Sleep Mode.

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.

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.

Warning

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

Note: 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.

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Radical-7 Safety Information, Warnings, and Cautions

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.

Note: Do not loop the sensor cable into a tight coil or wrap around the device, as this can damage the sensor cable.

Note: Patient Safety - If a sensor is damaged in any way, discontinue use immediately.

Note: Failure to apply the sensor properly may lead to incorrect measurements.

Note: 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).

Note: 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.

Note: High-intensity extreme lights (including pulsating strobe lights and direct sunlight) directed on the sensor, may not allow the Radical-7 to obtain readings.

Note: 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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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 digital 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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Radical-7 Chapter 1: Technology Overview

Masimo SET DST

This figure is for conceptual purposes only.

General Description for Oxygen Saturation (SpO2)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for neonates.

The sensor is connected to the Pulse CO-Oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data in three ways:

1. As a percent value for arterial oxygen saturation (SpO2)

2. As a pulse rate (PR)

3. As a plethysmographic waveform

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 mode 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.

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Radical-7 Chapter 1: Technology Overview

Functional Oxygen Saturation

The Radical-7 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 that carboxyhemoglobin is not capable of transporting oxygen, but is recognized as oxygenated hemoglobin by conventional pulse oximetry.

General Description for Pulse Rate (BPM)

Pulse rate, 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.

General Description for Pleth Variability Index (PVI)

The pleth variability index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percentage (0-100%).

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.

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Radical-7 Chapter 1: Technology Overview

rainbow Pulse CO-Oximetry Technology

rainbow Pulse CO-Oximetry technology is governed by the following principles:

1. 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).

2. 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.

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Radical-7 Chapter 1: Technology Overview

1. Light Emitting Diodes (LEDs)

(7 + wavelengths)

2. Detector

The Radical-7 uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma.

The Radical-7 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 Radical-7 for calculation.

Once the Radical-7 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient’s functional oxygen saturation (SpO2 [%]), blood levels of carboxyhemoglobin (SpCO [%]), methemoglobin (SpMet [%]), total hemoglobin concentration (SpHb [g/dL]) and pulse rate (BPM). The SpCO, SpMet and SpHb measurements rely on a multi-wavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin and the concentration of total hemoglobin in arterial blood. In an ambient temperature of 35º C the maximum skin surface temperature has been measured at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure.

Pulse CO-Oximetry vs. Drawn Whole Blood Measurements

When SpO2, SpCO, SpMet, and SpHb measurements obtained from the Radical-7 (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, SpCO, SpMet, SpHb, and SpOC measurements of the Radical-7. 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 (PO2) and saturation, such as: pH,temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. In the case of SpCO, different results are also expected if concentration of methemoglobin in the blood gas sample is abnormal (greater than 2% for methemoglobin concentration).

High levels of bilirubin may cause erroneous SpO2, SpMet, SpCO, 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, carboxyhemoglobin, and methemoglobin concentration 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, SpCO, SpMet, SpHb, and SpOC may

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Radical-7 Chapter 1: Technology Overview

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. The measurement is taken by a sensor capable of measuring SpHb, usually on the fingertip for adult and pediatric patients.

The sensor connects directly to the Pulse CO-Oximeter or with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as measurement of total hemoglobin concentration.

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 107.

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 (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 Hb) x Hb (g/dL) x HbO2 + PaO2 (mm Hg) x (0.3 ml O2/100 mm Hg/dL)

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 (PaO2 [mm Hg] x [0.3 ml O2/ 100 mm Hg/dL]) is approximately 0.3 ml/dL. Furthermore, for typical carboxyhemoglobin and methemoglobin levels, the functional saturation (SpO2) 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.

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