Masimo RAD7CA User Manual

Download

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.

www.masimo.com 1 Masimo

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

www.masimo.com 3 Masimo

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

www.masimo.com 4 Masimo

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

www.masimo.com 5 Masimo

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.

www.masimo.com 7 Masimo

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

www.masimo.com 9 Masimo

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.

www.masimo.com 10 Masimo

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.

www.masimo.com 11 Masimo

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.

www.masimo.com 12 Masimo

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

www.masimo.com 13 Masimo

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

www.masimo.com 14 Masimo

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.

www.masimo.com 15 Masimo

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.

www.masimo.com 16 Masimo

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.

www.masimo.com 17 Masimo

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.

www.masimo.com 18 Masimo

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.

www.masimo.com 19 Masimo

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.

www.masimo.com 20 Masimo

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.

www.masimo.com 21 Masimo

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.

www.masimo.com 22 Masimo

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.

www.masimo.com 23 Masimo

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.

www.masimo.com 24 Masimo

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.

www.masimo.com 25 Masimo

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.

www.masimo.com 26 Masimo

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

www.masimo.com 27 Masimo

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.

www.masimo.com 28 Masimo

Radical-7 Chapter 1: Technology Overview

General Description for SpOC

The above approximations result in the following reduced equation for oxygen content via the Pulse CO-Oximeter:

SpOC (ml/dL*) = 1.31 (ml O2/g Hb) x SpHb (g/dL) x SpO2 + 0.3 ml/dL

*When ml O2/g Hb is multiplied by g/dL of SpHb, the gram unit in the denominator of ml/g cancels the gram unit in the numerator of g/dL resulting in ml/dL (ml of oxygen in one dL of blood) as the unit of measure for SpOC. See Safety Information, Warnings, and Cautions on page 11.

General Description for Carboxyhemoglobin (SpCO)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of carboxyhemoglobin concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpCO measurement.

The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or through an instrument patient cable.

The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as percentage value for the SpCO, which reflect blood levels of carbon monoxide bound to hemoglobin.

Successful Monitoring for SpCO

A stable SpCO reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient’s fingertip (measurement site). Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion.

General Description for Methemoglobin (SpMet)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of methemoglobin concentration (SpMet) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpMet measurement.

The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as percentage value for the SpMet.

www.masimo.com 29 Masimo

Radical-7 Chapter 1: Technology Overview

Successful Monitoring for SpMet

A stable SpMet reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient’s fingertip (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.

SpCO, SpMet, and SpHb Measurements During Patient Motion

The Radical-7 displays measurements of SpCO, SpMet, and 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 SpCO, SpMet, or SpHb displays as dashes (---) and a message (Low SpCO SIQ, Low SpMet SIQ, or Low SpHb SIQ) displays to alert the clinician that the instrument does not have confidence in the value due to poor signal quality caused by excessive motion or other signal interference.

rainbow Acoustic Monitoring (RAM) Technology

rainbow Acoustic Monitoring (RAM) continuously measures a patient’s respiration rate

based on airflow sounds generated in the upper airway. The Acoustic Sensor translates airflow sounds generated in the upper airway to an electrical signal that can be processed to produce a respiration rate, measured as breaths per minute.

Respiratory sounds include sounds related to respiration such as breath sounds (during inspiration and expiration), adventitious sounds, cough sounds, snoring sounds, sneezing sounds, and sounds from the respiratory muscles [1].

These respiratory sounds often have different characteristics depending on the location of recording [2] and they originate in the large airways where air velocity and air turbulence induce vibration in the airway wall. These vibrations are transmitted, for example, through the lung tissue, thoracic wall and trachea to the surface where they may be heard with the aid of a stethoscope, a microphone or more sophisticated devices.

rainbow Acoustic Monitoring Architecture

The following figure illustrates how a respiratory sound produced by a patient can be turned into a numerical measurement that corresponds to a respiratory parameter.

www.masimo.com 30 Masimo

Radical-7 Chapter 1: Technology Overview

Patient

The generation of respiratory sounds is primarily related to turbulent respiratory airflow in upper airways. Sound pressure waves within the airway gas and airway wall motion contribute to the vibrations that reach the body surface and are recorded as respiratory sounds.

Although the spectral shape of respiratory sounds varies widely from person to person, it is often reproducible within the same person, likely reflecting the strong influence of individual airway anatomy [2-6].

Sensor

The sensor captures respiratory sounds (and other biological sounds) much like a microphone does. When subjected to a mechanical strain, (e.g., surface vibrations generated during breathing), the sensor becomes electrically polarized.

The degree of polarization is proportional to the applied strain. The output of the sensor is an electric signal that includes a sound signal that is modulated by inspiratory and expiratory phases of the respiratory cycle.

Acquisition System

The acquisition system converts the electric signal provided by the sensor into a digital signal. This format allows the signal to be processed by a computing device.

www.masimo.com 31 Masimo

Radical-7 Chapter 1: Technology Overview

Signal Processing

The digital signal produced by the acquisition system is converted into a measurement that corresponds to the respiratory parameter of interest. As shown in the previous figure, this can be performed by, for example, determining the digital signal envelope or outline which in turn may be utilized to determine the respiratory rate. In this way, a real-time, continuous breath rate parameter can be obtained and displayed on a monitor which, in many cases, may be real-time and continuous.

The respiratory cycle envelope signal processing principle is similar to methods that sample airway gasses and subsequently determine a respiratory rate.

[1] A.R.A. Sovijärvi, F. Dalmasso, J. Vanderschool, L.P. Malmberg, G. Righini, S.A.T. Stoneman. Definition of terms for applications of respiratory sounds. Eur Respir Rev 2000; 10:77, 597-610.

[2] Z. Moussavi. Fundamentals of respiratory sounds analysis. Synthesis lectures on biomedical engineering #8. Morgan & Claypool Publishers, 2006.

[3] Olsen, et al. Mechanisms of lung sound generation. Semin Respir Med 1985; 6: 171-179.

[4] Pastercamp H, Kraman SS, Wodicka GR. Respiratory sounds – Advances beyond the stethoscope. Am J Respir Crit Care Med 1977; 156: 974-987.

[5] Gavriely N, Cugell DW. Airflow effects on amplitude and spectral content of normal breath sounds. J Appl Physiol 1996; 80: 5-13.

[6] Gavrieli N, Palti Y, Alroy G. Spectral characteristics of normal breath sounds. J Appl Physiol 1981; 50: 307-314.

www.masimo.com 32 Masimo

Chapter 2: Radical-7 Descriptions

The following chapter contains the Radical-7 descriptions, including descriptions of the Handheld monitor , the Standalone monitor, and the optional SatShare monitor interface.

General System Description

The Radical-7 system includes the following:

1. Instrument

2. Patient Cable

3. Sensor

www.masimo.com 33 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

The Handheld contains the majority of the device features. All measurements and instrument status datum are displayed on the touchscreen. All user input is performed through the touchscreen and control buttons. The sensor cable connector is located on the Handheld.

The Handheld snaps into the Docking Station to provide a fully featured standalone monitor. The Docking Station connects to AC power for standalone operation or charging of the Handheld. An optional Docking Station battery is available. The Standalone features Nurse Call, analog output, and serial output.

Utilizing a SatShare cable, the standalone Radical-7 also interfaces with the SpO2 input of a validated multi-parameter patient monitor, instantly upgrading the conventional pulse oximetry to Masimo SET pulse oximetry. The SatShare cable attaches to the back of the Radical Docking Station, and SatShare cables are available to interface with most multi-parameter patient monitors.

Functionality of the Radical-7

The Radical-7 provides the functionality of three instruments in one:

Handheld Pulse CO-Oximeter

The Radical-7 is a fully featured Handheld.

Standalone Pulse Oximeter

The Radical-7 is a fully featured Standalone Pulse-Oximeter, and Acoustic Monitor.

Monitor Interface

The Radical-7 interfaces to the SpO2 input module of multi-parameter patient monitors to upgrade conventional pulse oximetry technology on the multi-parameter monitor to Masimo SET technology.

www.masimo.com 34 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

Handheld Release button

Press down the Handheld Release Button to pull the Handheld off the Docking Station.

Touchscreen Display

The Touchscreen Display refers to the interactive area on the Handheld. There are different Display Views that can appear in this area. For more about using the Touchscreen and Display Views, see Changing the Size of Parameter Values on page 51.

Profile button

The Profile button provides instant access to the Profile Screen. See Chapter 5: Configurations on page 89.

Power button

To turn on the Radical-7, press the Power button. To turn off, press and hold the button for more than 2 seconds.

Home button

The Home button provides instant access to the Display View screen.

Alarm Silence Button

The Alarm Silence button temporarily silences alarms. See Silencing the Alarms on page 95.

Speaker

The speaker indicates audio alarms. Care should be taken not to cover the speaker and muffle the audible alarm volume.

Patient Cable Connector

Connect a patient cable or a direct cable sensor into the Radical-7

Handheld

All user input and displays are controlled by this component. The patient cable connects into the connector on the Handheld instrument. The Handheld is battery powered and can be used either as a transport monitor or as a Handheld Pulse CO-Oximeter for spot checks.

Handheld Front Panel

The following figure numbers and corresponding table describes the hardware features of the Radical-7.

www.masimo.com 35 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

Item

Description

The Radical-7 Handheld interfaces with the Docking Station through this connector.

The optional Pole Clamp accessory attaches to this holder. See the Directions for Use of the Pole Clamp accessory for attachment instructions.

The Radical-7 Handheld is powered by a Lithium Ion battery located in this compartment. For battery care and replacement, see Battery Operation and Maintenance on page 127.

Handheld Back Panel

The Handheld back panel features the interconnection to the Docking Station, an accessory mount for the pole clamp accessory and access to the Handheld battery pack.

www.masimo.com 36 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

Docking Station Features

RDS-1

RDS-2

RDS-3

  

SatShare Interface



Serial RS-232 interface

 

Nurse Call/Analog Output interface

 

10-Hour Extended Battery

Automatic Display Rotation Support (Gravity Detector)

 

Docking Station Battery Charging indicator



Handheld Battery Charging indicator

  

Visual Alarm indicator

 

AC Power indicator

  

Docking indicator

 

Standalone

When the Radical-7 Handheld is placed into the Docking Station, they become a full-featured standalone system. In this manual, when the Handheld and the Docking Station are connected, they are referred to Standalone. The Standalone acts as a battery charger for the Handheld and has AC power connection capabilities. If the AC power from the wall outlet is temporarily interrupted, then the battery in the Handheld will allow continuous operation.

The Standalone can also interface with serial instruments, Nurse Call, or analog output instruments, and multi-parameter patient monitors through a SatShare cable. There are several models of Docking Stations available. The following table outlines which features are available for each model of Docking Station.

The RDS-1 and RDS-3 are optionally available with SafetyNet capability.

www.masimo.com 37 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

Item

Description

Docking Station Battery Charging Indicator

The Docking Station Battery Charging indicator is illuminated when the Docking Station battery is charging. The indicator blinks just prior to charging. The Charging Indicator does not illuminate when the battery is fully charged or when the battery is not present.

Handheld Battery Charging indicator

The Handheld Battery Charging indicator is illuminated when the Handheld battery is charging. The indicator blinks just prior to charging. The Charging Indicator does not illuminate when the battery is fully charged or when the battery is not present.

Visual Alarm Indicator

The Visual Alarm indicator is illuminated when an alarm condition is active and the Alarm Status Indicator is shown.

AC Power Indicator

The AC Power indicator is illuminated when the Radical-7 Docking Station is plugged into AC line power.

Docking Indicator

The Docking indicator is illuminated when the Handheld instrument is turned on and is properly interfaced to a Docking Station.

Standalone Front Panel

The following figure and corresponding text review the features of the Radical-7 Standalone. Note that when the Standalone is turned on, all indicator LEDs initially turn on and off at start up.

www.masimo.com 38 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

Item

Connector

Description

Serial Output connector

Use the Serial Output connector with a ferrite bead installed to connect a serial instrument, including a serial printer, a monitoring system or PC to the Radical-7. The data is provided in standard RS-232C format. All external instrument connections to the Serial Output connector must be IEC-60950 compliant.

Analog Output/Nurse Call connector

Use the Analog Output connector with a ferrite bead installed to interface with an analog output instrument, such as a chart recorder or Nurse Call system. All external instrument connections to the Analog Output/Nurse Call connector must be IEC-60950 compliant.

See Serial Interface Specifications on page 118.

SatShare Cable connector

Use the SatShare Cable connector to connect a SatShare cable to the SpO2 input connector of a multi-parameter patient monitor. All external instrument connections to the SatShare Cable Connector must be IEC-60601-1-1 compliant. SatShare cables are available to interface with most major multi-parameter patient monitors. Check the label on the SatShare cable and the SatShare Directions for Use to ensure that the correct cable is used for each type of patient monitor.

Visit www.masimo.com for the latest SatShare cables and validated instruments.

Standalone Back Panel

The following figure and corresponding text review the features of the Radical-7 Standalone.

www.masimo.com 39 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

Item

Connector

Description

Power Entry module

The Power Entry module contains the input connector for AC power and two fuses. The AC input provides power to the system from the AC line. Always connect the Radical-7 to the mains power for continuous operation and/ or battery recharging. Note: Use the power cord as the means to disconnect the instrument from the mains power supply.

Equipotential Ground connector

Use the Equipotential Ground connector for grounding.

Monitor Interface

The Radical-7 has a unique SatShare interface that links it to most existing multi-parameter patient monitors through the pulse oximetry patient cable or SpO2 input connector.

 Upgrades any approved and validated monitor to Masimo SET performance by

using the calculated SpO2 and pulse rate determined by Radical-7 to simulate an ideal plethysmograph waveform, which is sent to the validated multi-parameter patient monitor.

 Connects into the SpO2 patient cable or SpO2 input connector of the

multi-parameter patient monitor.

See Setting Up and Using SatShare on page 44.

www.masimo.com 40 Masimo

Chapter 3: Setup

The following chapter contains information about setting up the Radical-7 before use.

Unpacking and Inspection

To unpack and inspect the device

1. Remove the instrument from the shipping carton and examine it for signs of

shipping damage.

2. Check all materials against the packing list. Save all packing materials, invoice

and bill of lading. These may be required to process a claim with the carrier.

3. If anything is missing or damaged, contact the Technical Service Department.

Docking Station Power Requirements

See Safety Information, Warnings, and Cautions on page 11.

See Return Procedure on page 132.

 Always use a hospital-grade, AC power cable to connect the Docking Station to an

AC power source.

 Do not connect the Docking Station to an AC outlet that is controlled by a switch

because the power to the Docking Station may be inadvertently switched off.

 Verify the AC power voltage and line frequency before use.  Verify that the power source can provide an adequate power rating as indicated

on the rear panel of the Docking Station.

 The Radical-7 is designed to operate on 100 to 240VAC, 47-63 Hz.  The Radical-7 is rated at 55 VA max.  Connect a hospital-grade power cable (IEC-320 connector type at the

instrument) to the Power Entry module on the Docking Station.

 Connect the power cable to an AC power source.  Ensure that the instrument is adequately powered by verifying that the AC power

indicator on the Docking Station is illuminated.

www.masimo.com 41 Masimo

Radical-7 Chapter 3: Setup

Operating Environmental Conditions

Temperature

+5°C to +40°C, +41°F to +104°F

humidity

5% to 95%, non-condensing

Operating Altitude

1060 mbar to 500 mbar pressure -1000 ft to 18,000 ft (-304 m to 5,486 m)

Setting Up the Docking Station

Place the Docking Station on a stable hard flat surface near the patient. Always place the Radical-7 on a dry surface. Maintain a minimum of 3 cm (1 inch) free space around the Radical-7. Make sure that the Radical-7 speaker is not covered to avoid a muffled alarm sound.

The Radical-7 Handheld, Docking Station or Standalone should not be operated outside the following environmental conditions:

See Device Settings on page 74.

Initial Battery Charging

Before use, the Radical-7 Handheld battery and the Docking Station battery must be charged completely. See Electrical Safety Information, Warnings, and Cautions on page 18.

To charge the Handheld and Docking Station for the first time

1. Attach the Handheld to the Docking Station.

2. Plug in the AC power cord to power entry module. Make sure it is securely plugged

in.

3. Plug the AC power cord into an AC power source.

4. Verify that the batteries are charging.

 The Battery Charging indicators on the Docking Station flash prior to

charging and remain illuminated while the batteries are charging.

See Standalone Front Panel on page 38 and Battery Operation and Maintenance on page

127.

Setting Up for Philips, Agilent, or HP VueLink

To set up for use with VueLink compatible monitors (Philips, Agilent, or HP)

1. On the Radical-7, on the device output screen, for the serial option, select Hp

VueLink.

2. Connect one end of the VueLink cable to the Serial Output connector on the

Docking Station.

3. Connect the other end of the VueLink cable to the VueLink module and insert the

module into the VueLink compatible monitor rack.

www.masimo.com 42 Masimo

Radical-7 Chapter 3: Setup

The SpO2 and pulse rate values appear on the VueLink compatible monitor.

4. In order for the plethysmographic waveform to be displayed on the VueLink

compatible monitor, and for the VueLink monitor to convey alarm conditions measured by the Radical-7, the VueLink compatible monitor must be properly configured.

5. See instructions for use provided with the VueLink compatible monitor and the

VueLink module. See Device Related Safety Information, Warnings, and Cautions on page 15 and Serial Interface Specifications on page 118.

Setting Up for SpaceLabs Flexport

To set up for use with SpaceLabs Flexport

1. On the Radical-7, on the device output screen, for the serial option, select

SpaceLabs Flexport.

2. Connect one end of the Spacelabs Flexport cable to the Serial Output connector

on the Docking Station.

3. Connect the other end of the Spacelabs Flexport cable to the Spacelabs Universal

Flexport connector.

The SpO2 and pulse rate values appear on the Spacelabs screen.

4. In order for the plethysmographic waveform to be displayed on the Spacelabs

screen, and for the Spacelabs monitor to convey alarm conditions measured by the Radical-7, the Spacelabs monitor must be properly configured.

5. See instructions for use provided with the Spacelabs monitor. See Device Related

Safety Information, Warnings, and Cautions on page 15 and Serial Interface Specifications on page 118.

www.masimo.com 43 Masimo

Radical-7 Chapter 3: Setup

Setting Up and Using SatShare

Parameter values from the Radical-7 can be displayed on a multi-parameter monitor through the SatShare feature. The SatShare feature provides an ideal, simulated plethysmographic waveform that corresponds to the parameter values determined the by Radical-7. This waveform may be used to display these values on multi-parameter monitors through the multi-parameter oximetry sensor or input connector.

It is recommended that the Radical-7 be positioned near the multi-parameter monitor, with the Radical-7 screen displaying the plethysmographic waveform and the parameter values. Refer to the instructions for use provided with the multi-parameter monitor. See Device Related Safety Information, Warnings, and Cautions on page 15.

To set up for use with SatShare interface

1. Select the SatShare cable that is appropriate for the multi-parameter monitor.

For the latest list of available SatShare cables and validated instruments, see www.masimo.com.

2. Connect the labeled end of the SatShare cable to the SatShare Cable connector

on the Docking Station. See Standalone Back Panel on page 39. For a secure connection, tighten the cable connector screws.

3. Connect the other end of the SatShare cable to one of the following:

 Sensor connector of the multi-parameter monitor cable  Directly to the multi-parameter monitor

4. Verify that the Radical-7 recognizes the SatShare cable. If functional, the name of

the SatShare cable displays on the Radical-7 screen.

5. As appropriate, configure alarm limits on the multi-parameter monitor.

6. Set the averaging time for the multi-parameter monitor to its lowest setting (or

fastest response). The ideal waveform for the Radical-7 requires additional averaging by the monitor. If the averaging time of the multi-parameter monitor is not changed, the time to display physiological changes in saturation on the monitor is increased with SatShare. However, the delay can be minimized by reducing the averaging time on the multi-parameter monitor.

7. While in the SatShare mode, if there are any significant discrepancies between

the readings from Radical-7 and those on the monitor displaying the values obtained from SatShare, the values reported by the Radical-7 are to be considered the correct values.

8. It is possible to use the Radical-7 with SatShare while the Radical-7 is not

connected to AC power. However, in this configuration, battery run time is reduced. See Battery Operation and Maintenance on page 127.

9. On the Radical-7, turn on the Satshare Numbers option. See Device Output on

page 79.

10. If displaying the simulated waveform is not desirable, it is recommended to turn

off the plethysmographic waveform display of the multi-parameter patient monitor. See Serial Interface Specifications on page 118.

www.masimo.com 44 Masimo

1. Display View

To access other screens, tap a value on the Display View. See About the Display View on page 48.

2. Profiles button

To the access the Profiles screen, press Profiles. See Chapter 5: Configurations on page 89.

3. Alarm Silence button

To temporarily silence audible alarms, press Alarm Silence. See Silencing the Alarms on page 95.

4. Home button

To return to the Display View, press Home.

5. Power button

To turn on the Radical-7, press the Power button. To turn off, press and hold the button for more than 2 seconds

Chapter 4: Operation

The following chapter contains information about using the Radical-7.

Using the Touchscreen and Buttons

www.masimo.com 45 Masimo

Radical-7 Chapter 4: Operation

Using Screenlock

When turned on, the Screenlock feature may prevent accidental interaction with Display View.

Using the Screenlock feature

1. When turned on, any interaction with the Display View triggers the Screenlock

feature.

2. To bypass Screenlock when it appears, press and hold the Lock icon until it

unlocks.

3. To turn on or turn off Screenlock, see Access Control on page 77.

Using the Home Button

One option to return to Display View is by using the Home button.

To return to Display View using the Home button

 From any screen, press Home.

www.masimo.com 46 Masimo

Radical-7 Chapter 4: Operation

Navigating the Radical-7

Navigate the Radical-7 screens via the Display View or the Main Menu.

Display View

The following is the primary interactive screen that the user views.

To access the Main Menu screen

 Tap the gear icon at the lower right corner of the display.

Main Menu

The following is the Main Menu screen where users can access additional screens and information. Users can swipe the screen or tap the arrow icon to return to the Display View. See Accessing the Main Menu on page 55.

www.masimo.com 47 Masimo

Radical-7 Chapter 4: Operation

About the Display View

The Display View consists of different areas:

Status Bar See About the Status Bar on page 49.

Parameter Display See Changing the Size of Parameter Values on page 51.

Trend Field See Waveform and Trend Views on page 52.

www.masimo.com 48 Masimo

Radical-7 Chapter 4: Operation

Small Parameter View. The gear icon on the right of the Small Parameter View is one way to access the Main Menu. See Accessing the Main Menu on page 55.

About the Status Bar

The Status Bar is visible on the top portion of the Display View.

Status Bar

Access additional screens, more information, or toggle features by tapping directly on any of the following indicators in the Status Bar.

 Sensitivity Modes. See Overview of Sensitivity Modes on page 50.  Messages on page 100. (read only)  WiFi on page 76.  Battery on page 77.  Sounds on page 73.  Time settings. See Localization on page 75.

www.masimo.com 49 Masimo

Radical-7 Chapter 4: Operation

Overview of Sensitivity Modes

Three sensitivity levels enable a clinician to tailor the response of the Radical-7 to the needs of the particular patient situation. Access the menu by tapping on the indicator in the upper left corner of the Display View.

The sensitivity levels are as follows:

 Normal Sensitivity

This is the recommended mode for patients that are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as an intensive care unit (ICU).

 Adaptive Probe Off Detection (APOD) Sensitivity

This is the recommended monitoring mode where there is a high probability of the sensor becoming detached. It is also the suggested mode for care areas where patients are not visually monitored continuously. This mode delivers enhanced protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient due to excessive movement.

 Maximum Sensitivity (MAX)

This mode is recommended for patients with low perfusion or when the low perfusion message is displayed on the screen in APOD or normal sensitivity mode. This mode is not recommended for care areas where patients are not monitored visually, such as general wards. It is designed to interpret and display data at the measuring site when the signal may be weak due to decreased perfusion. When a sensor becomes detached from a patient, it will have compromised protection against erroneous pulse rate and arterial saturation readings.

Toggle between the sensitivity modes by pressing the indication on the top left of the Display View. The sensitivity mode also can be changed in the Profile menu which is accessible from the Main Menu.

Note that the device will revert to APOD mode after a power cycle.

See Changing Profiles Settings on page 90.

www.masimo.com 50 Masimo

Radical-7 Chapter 4: Operation

Changing the Size of Parameter Values

To change the size of parameter values on the Display View

1. On the Small Parameter view, press and hold any one of the active parameters

(shown above).

2. When the parameter value dims, shakes, and grows in size, drag and drop that

parameter onto the center of the screen.

3. The parameter value appears on the screen in a larger format.

Note that the device automatically configures the screen for optimal display of the parameter values.

4. To remove parameter values from the larger format display, press and hold the

larger parameter value. Then drag and drop the parameter value back to the Small Parameter view.

5. When you finish making changes, you can lock the customized format. See

Parameter Layout.

Trend Field

The Trend Field allows users to access various customizable views. See Trends on page 81.

www.masimo.com 51 Masimo

Radical-7 Chapter 4: Operation

To access trend, waveform, or customize the views on the Display View screen

1. Tap the Trend Field.

2. The following screen appears.

3. Swipe up or swipe down the available options.

4. Tap on the desired option.

5. The Trend Field displays trend data specific to the selected option.

Waveform and Trend Views

The following section contain information about trends and waveforms available from the Trend Field on the Display View screen. The following are examples of some of the views that are available.

www.masimo.com 52 Masimo

Radical-7 Chapter 4: Operation

Pleth + Siq IQ + Acoustics View

Shows the parameter values on the top of the screen. The waveform is located below the parameter values. The Small Parameter view is located along the bottom of the screen. This view contains the Pleth Waveform with signal quality indications superimposed on top of the acoustic waveform.

Signal Quality (Sig IQ) Indicators

The signal quality, on each individual pulsation, is conveyed by vertical bars, as shown below. The height of the bar indicates signal quality. The higher the bar, the better the signal quality.

www.masimo.com 53 Masimo

Radical-7 Chapter 4: Operation

Pleth + Sig IQ View

RRa Waveform View

Shows the parameter values on the top of the screen. The RRa waveform is located below the parameter values. The Small Parameter view is located along the bottom of the screen. Acoustic Respiratory Rate (RRa) must be available for this feature to be shown. This view contains acoustic respiratory rate waveform only.

www.masimo.com 54 Masimo

Radical-7 Chapter 4: Operation

Parameter Quick Trend View

This view displays the quick trend of the selected parameter over an adjustable period of time. The default is 1 hour. Expand the quick trend to the full trend view by tapping the expand icon of the waveform display.

Using two fingers, the user can expand and zoom the information that is inside this Trend Field.

Accessing the Main Menu

To access Main Menu from the Display View, tap the gear icon on the bottom right corner of the Small Parameter View.

www.masimo.com 55 Masimo

Radical-7 Chapter 4: Operation

Device Settings

See Device Settings on page 74.

Parameter Settings

See Parameter Settings on page 58.

Profiles

See Changing Profiles Settings on page 90.

3D Alarms

See 3D Alarms on page 98.

Navigating the Main Menu

 From the Main Menu screen, tap the icons for any of the following screens:

www.masimo.com 56 Masimo

Radical-7 Chapter 4: Operation

Trends

See Trends on page 81 and Trend Field on page 51.

Sound

See Sounds on page 73.

About

See About on page 87.

www.masimo.com 57 Masimo

Radical-7 Chapter 4: Operation

Parameter Settings

The following is an example of the Parameter Settings screen. Only parameters that have been loaded onto your system will be visible.

To access any of the available parameter setting screens

1. From the Parameter Settings screen, to access your desired parameter, flick the

on-screen icons left or right.

2. Tap the icon of your desired parameter. For details, see any of the following

sections.

SpO2 Settings on page 61.

RRa Settings on page 66.

RRp Settings on page 67.

SpHb Settings on page 62.

PVI Settings on page 69.

SpCO Settings on page 70.

SpMet Settings on page 71.

SpOC Alarms on page 72.

www.masimo.com 58 Masimo

Radical-7 Chapter 4: Operation

Accessing Parameter Information

Additional information about each parameter is available.

To access additional information about parameters

1. From the parameter settings screen, tap the About icon. The following is an

example for SpHb.

2. An About screen appears for the selected parameter.

www.masimo.com 59 Masimo

Radical-7 Chapter 4: Operation

Overview of In Vivo Adjustment

The In Vivo Adjustment feature lets clinicians manually adjust one or more clinical parameters to match that of a corresponding laboratory reference for continuous trending. To remind clinicians that the feature is active, an offset value displays alongside the adjusted parameter value.

When the In Vivo Adjustment is set to Yes, the feature is active (turned on) and a positive or a negative offset value appears, as shown in the following illustration.

In Vivo offset is set to zero for any of the following:

 Cable or sensor disconnect from instrument.  Sensor goes off patient causing a sensor initialization to occur.  8 hours has elapsed since the In Vivo value was activated.  The user turns off In Vivo.

Offset value

Offset value appears and indicates that In Vivo Adjustment is active. A positive value means that the value is increased (according to a laboratory reference value as entered by a clinician) and a negative value means the value is decreased (according to a laboratory reference value as entered by a clinician).

In the example below, the SpO2 value is offset (highlighted) by -1.0 and SpHb is offset by +0.4.

The In Vivo Adjustment feature can be set to Yes or No. the factory default setting is No. If set to Yes, the parameter value is adjusted and an offset value appears. The offset value is set by the user.

The feature applies to any of the following parameters:

In Vivo for SpO2 on page 62.

In Vivo for SpHb on page 64.

In Vivo for SpCO on page 71.

In Vivo for SpMet on page 72.

www.masimo.com 60 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

Configurable Options

High Limit

High Limit is the upper threshold that triggers an alarm.

Off

2% to 99% in steps of 1, or Off

When set to Off, alarms are disabled

Low Limit

Low Limit is the lower threshold that triggers an alarm.

88%

1% to 98% in steps of 1

Rapid Desat

Sets the Rapid Desat limit threshold to the selected amount below the Low Alarm Limit. When SpO2 value falls below rapid desat limit the audio and visual alarm are immediately triggered without respect to the alarm delay.

-10%

Off, -5%, or -10%

Alarm Delay

When an alarm condition is met, this feature delays the audible part of an alarm.

5 seconds

0, 5, 10, or 15 seconds

Adaptive Threshold Alarm (ATA)

ATA establishes patient-specific limit thresholds based upon the baseline value of the parameter.

See Adaptive Threshold Alarm (ATA) Feature on page 97.

Off

Off or On

SpO2 Settings

Access any of the following options:

Alarms for SpO2.

Additional Settings for SpO2 on page 62.

Accessing Parameter Information on page 59.

Alarms for SpO2

From the Alarms screen, change any of the following options:

www.masimo.com 61 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

Averaging Time

The length of time over which the system calculates the average of all data points.

8 seconds

2-4, 4-6, 8, 10, 12, 14, or 16 seconds

FastSat

See Overview of FastSat on page

62.

Off

On or Off Options

Description

Factory Default Settings

User Configurable Settings

Enabled

See Overview of In Vivo Adjustment on page 60.

Yes or No Offset Amount

See Overview of In Vivo Adjustment on page 60.

0 when turned on

%SpO2 can be adjusted to a difference of ± 6%

Additional Settings for SpO2

From the Additional Settings screen, you change any of the following options:

Overview of FastSat

FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend.

When the Radical-7 is set to FastSat On, the averaging algorithm evaluates all the saturation values providing an averaged saturation value that is a better representation of the patient’s current oxygenation status. With FastSat, the averaging time is dependent on the input signal.

In Vivo for SpO2

From the In Vivo screen, you change any of the following options:

SpHb Settings

From the SpHb Settings screen, you access any of the following screens:

SpHb Alarms on page 63.

Additional Settings for SpHb on page 63.

Accessing Parameter Information on page 59.

www.masimo.com 62 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

High Limit

The High Limit is upper threshold that triggers an alarm.

17.0 g/dL

(11.0 mmol/L)

2.0 g/dL to 24.5 g/dL in steps of 0.1 g/dL, or Off

(2.0 mmol/L to 15.0 mmol/L in steps of 0.1 mmol/L, or Off)

When SpHb Precision is set to 1.0, the values are rounded down.

When set to Off, alarms are disabled.

Low Limit

The Low Limit is lower threshold that triggers an alarm.

7.0 g/dL

(4.0 mmol/L)

Off, or 1.0 g/dL to 23.5 g/dL in steps of 0.1 g/dL

(Off, or 1.0 mmol/L to 14.5 mmol/L, in steps of 0.1 mmol/L)

When SpHb Precision is set to 1.0, values are rounded down.

When set to Off, alarms are disabled.

Options

Description

Factory Default Settings

User Configurable Settings

Averaging Time

The length of time over which the system calculates the average of all data points.

Medium

Short, Medium, or Long

Calibration

Provides an Arterial (SpHb) or Venous (SpHbv) that displays on the main screen.

Venous

Arterial or Venous

SpHb Alarms

From the Alarms screen, change any of the following options:

Additional Settings for SpHb

From the Additional Settings screen, you change any of the following options:

www.masimo.com 63 Masimo

Radical-7 Chapter 4: Operation

Precision

Allows the user to set the decimal for SpHb.

0.1

0.1, 0.5, or 1.0 (whole numbers)

Unit of Measure

Displays total hemoglobin (SpHb) as g/dL (grams per deciliter) or mmol/L (milimoles per liter).

g/dL

mmol/L or g/dL

Options

Description

Factory Default Settings

User Configurable Settings

In Vivo Calibration

Enable/Disable

See Overview of In Vivo Adjustment on page 60.

Yes or No In Vivo

Calibration Offset

See Overview of In Vivo Adjustment on page 60.

0.0

SpHb (± 3 g/dL with steps of ± 0.1 g/dL)

Options

Description

Factory Default Settings

Options

High Limit

The High Limit is upper threshold that triggers an alarm.

140 BPM

35 to 235 BPM, in steps of 5 BPM

Low Limit

The Low Limit is lower threshold that triggers an alarm.

50 BPM

30 to 230 BPM, in steps of 5 BPM

In Vivo for SpHb

From the In Vivo screen, change any of the following options:

PR Settings

From the Additional Settings screen, you change any of the following options:

PR Alarms on page 64.

Accessing Parameter Information on page 59

PR Alarms

From the PR Alarms screen, change any of the following options:

www.masimo.com 64 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

High Limit

The High Limit is upper threshold that triggers an alarm.

Off

Step Size:

0.04 to 0.09 in steps of

0.01

0.10 to 0.90 in steps of

0.10

1 to 19 in steps of 1, or Off

Low Limit

The Low Limit is lower threshold that triggers an alarm.

Off

Step Size:

Off, or 0.03 to 0.09 in steps of 0.01

0.10 to 0.90 in steps of

0.10

1 to 18 in steps of 1

Options

Description

Factory Default Settings

User Configurable Settings

Averaging Time

The length of time over which the system calculates the average of all data points.

Long

Short or Long

Perfusion Index (PI) Settings

From the PI Settings screen, access any of the following screens:

PI Alarms on page 65.

Additional Settings for PI on page 65.

Accessing Parameter Information on page 59.

PI Alarms

From the Alarms screen, change any of the following options:

Additional Settings for PI

From the Additional Settings screen, change any of the following options:

www.masimo.com 65 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

Configurable Options

High Limit

The High Limit is upper threshold that triggers an alarm.

30 breaths per minute

5 to 69 breaths per minute in steps of 1, or Off

Low Limit

The Low Limit is lower threshold that triggers an alarm.

4 breaths per minute

4 to 68 breaths per minute in steps of 1

Respiratory Pause

The duration of time that triggers an alarm if no breaths are detected.

15 seconds

20, 25, 30, 35, 40, or 15 seconds

Alarm Delay

When a High or Low alarm condition occurs, this feature delays the audible part of an alarm.

30 seconds

60, 0, 10, 15, or 30 seconds

RRa Settings

From the RRa Settings screen, access any of the following screens:

RRa Alarms on page 66.

Additional Settings for RRa on page 67.

Accessing Parameter Information on page 59.

RRa Alarms

From the Alarms screen, change any of the following options:

www.masimo.com 66 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

Averaging Time

The length of time over which the system calculates the average of all data points.

Slow

Trending, No Averaging, Fast, Medium, or Slow

Freshness

The duration of time that, during interference, the system displays the last valid reading.

5 minutes

10, 15, 0, 1, or 5 minutes

Additional Settings for RRa

From the Additional Settings screen, change any of the following options:

RRp Settings

If RRa is loaded on the Radical-7, RRp alarms and RRp settings are used instead of RRa. There are no separate screens for RRp.

From the RRp Settings screen, access any of the following screens:

RRp Alarms on page 68.

Additional Settings for RRp on page 69.

www.masimo.com 67 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default

Configurable Options

High Limit

The High Limit is upper threshold that triggers an alarm.

5 to 69 breaths per minute, or Off

Low Limit

The Low Limit is lower threshold that triggers an alarm.

4 to 68 breaths per minute, or Off

Alarm Delay

When an alarm condition is met, this feature delays the audible part of an alarm.

0, 10, 15, 30, 45

Overview of RRp

Respiration rate can be determined by the plethysmographic waveform (RRp) using a SpO2 sensor. Respiration rate monitoring, derived from the plethysmographic waveform, measures a patient's respiratory rate based on amplitude changes that correspond to the respiratory cycle.

Inaccurate measurements may be caused by:

 Low arterial perfusion  Motion artifact  Low arterial oxygen saturation  Excessive ambient or environmental noise  Improper sensor placement

The device can display respiration rate derived from the plethysmographic waveform under the following conditions:

 Respiration rate parameter installed on the instrument  Active optical channel  Dual Rainbow cable is disconnected

RRp Alarms

From the Alarms screen, change any of the following options:

www.masimo.com 68 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

Averaging

The length of time over which the system calculates the average of all data points.

Slow

No, Fast, Medium, Slow, Trending

Freshness

The duration of time that, during interference, the system displays the last valid reading.

5 minutes

0, 1, 5, 10, 15 minutes

Options

Description

Factory Default Settings

User Configurable Settings

High Limit

The High Limit is upper threshold that triggers an alarm.

Off

2 to 99, in steps of 1, or Off

When set to Off, alarms are disabled.

Low Limit

The Low Limit is lower threshold that triggers an alarm.

Off

Off, 1 to 98 in steps of 1

When set to Off, alarms are disabled.

Additional Settings for RRp

From the Additional Settings screen, change any of the following options:

PVI Settings

From the PVI Settings screen, access any of the following options:

PVI Alarms on page 69.

Additional Settings for PVI on page 70.

Accessing Parameter Information on page 59

PVI Alarms

From the Additional Settings screen, change any of the following options:

www.masimo.com 69 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

Averaging Time

The length of time over which the system calculates the average of all data points.

Long

Short or Long Options

Description

Factory Default Settings

User Configurable Settings

High Limit

The High Limit is the upper threshold that triggers an alarm.

2% to 98%, in steps of 1%, or Off

When set to Off, alarms are disabled.

Low Limit

The Low Limit is the lower threshold that triggers an alarm.

Off

Off, 1% to 97%, in steps of 1%

When set to Off, alarms are disabled.

Additional Settings for PVI

From the Additional Settings screen, change any of the following options:

SpCO Settings

From the SpCO Settings screen, you can access the following screens:

SpCO Alarms on page 70.

Accessing Parameter Information on page 59.

SpCO Alarms

From the SpCO Settings screen, access the following screens:

www.masimo.com 70 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings Enabled

See Overview of In Vivo Adjustment on page 60.

Yes, No

Offset Amount

See Overview of In Vivo Adjustment on page 60.

Yes, No

± 9% in steps of ± 1%

Options

Description

Factory Default Settings

User Configurable Settings

High Limit

The High Alarm Limit is upper threshold that triggers an alarm.

3.0

1.0% to 2.0% in steps of 0.1

2.5% to 99.5% in steps of 0.5%, or Off

Low Limit

The Low Alarm Limit is lower threshold that triggers an alarm.

Off

Off, 0.1% to 2.0% in steps of 0.1%

2.5% to 99%, in steps of 0.5%

In Vivo for SpCO

From the In Vivo screen, access the following screens:

SpMet Settings

From the SpMet Settings screen, access the following screens:

SpMet Alarms on page 71.

Accessing Parameter Information on page 59.

SpMet Alarms

From the Alarms screen, change any of the following options:

www.masimo.com 71 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

Enabled

Match the corresponding laboratory reference for continuous trending.

Yes or No

Offset Amount

Helps offset individual patient bias that is expected when comparing a noninvasive measurement to a laboratory reference.

---

±3.0% in steps of ± 0.1%

Options

Description

Factory Default Settings

User Configurable Settings

High Limit

The High Limit is the upper threshold that triggers an alarm.

Off

2% to 34% in steps of 1, or Off

Low Limit

The Low Limit is the lower threshold that triggers an alarm.

Off

Off, or 1% to 33% in steps of 1

In Vivo for SpMet

From the In Vivo screen, access the following screens:

SpOC Settings

From the SpOC Settings screen, access the following screens:

SpOC Alarms on page 72.

Accessing Parameter Information on page 59.

SpOC Alarms

From the SpOC Alarms screen, access the following screens:

www.masimo.com 72 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

Alarm Volume

Sets the alarm volume and provides a sample of the alarm volume.

Level 4

Level 1 to 4 Pulse Tone Volume

Sets the volume of the tone that conveys the pulse rate.

Level 3

Off, Level 1 to 4

Silence Duration

Length of time that the audible alarm remains muted.

120 second

30, 60, 90, or 120 seconds

Sounds

From the Sounds screen, change any of the following options:

www.masimo.com 73 Masimo

Radical-7 Chapter 4: Operation

Device Settings

The following is an example of the Device Settings screen

From the Device Settings screen, you access any of the following options:

Screen Orientation on page 75.

Localization on page 75.

WiFi on page 76.

Battery on page 77.

Brightness on page 77.

Parameter Layout.

Access Control on page 77.

Device Output on page 79.

www.masimo.com 74 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

Auto Orientation

Allows the device to automatically adjust the Display screens depending on orientation.

Off or On

Orientation

Rotates the viewing screens depending on device orientation.

Landscape

Landscape: rotates the screen to horizontal viewing position

Inverted Landscape: rotates the screen to (180 degree) viewing position

Portrait: rotates the screen to vertical viewing position

Inverted Portrait: rotates the screen to vertical (180 degree) viewing position

Options

Description

Factory Default Settings

User Configurable Settings

Current Date

Default date

N/A

N/A Current Time

Default time

N/A

Language

Language in which the screens display.

English

Choose from available languages.

Screen Orientation

From the Screen Orientation screen, change any of the following options:

Localization

From the Localization screen, change any of the following options:

www.masimo.com 75 Masimo

Radical-7 Chapter 4: Operation

Time Zone

Setting based on Coordinated Universal Time (UTC).

A (UTC+1hr)

Choose your local time zone settings.

Date Format

Set the format of the date display on the Display View.

MM/DD/YYYY

DD/MM/YYYY

Time Format

Set the format of the time display as it will be shown on the Display View.

12 hour

24 hour or 12 hour

Line Frequency

Set to match regional power line frequency to allow for cancelation of noise introduced by fluorescent lights and other sources.

60 Hz

50 Hz or 60 Hz

Auto Set Date/Time

When connector to a WiFi network, automatically sets date and time.

Off

On or Off

Date

Manually set the numerical date if Auto Set Date/Time is Off.

MM/DD/YYYY

Choose month, date, and year.

Time

Manually set the hour and minute, AM or PM, if Auto Set Date/Time is Off.

12-hour format

Choose hour and minute.

Options

Description

Factory Default Settings

User Configurable Settings

WiFi

Enables or disables the wireless connection

Off

On or Off

Additional fields in the Wifi screen provide information about WiFi connection. These additional fields are read only and not configurable.

WiFi

When the Radical-7 is connected to a WiFi network, the Wifi icon located on the Status Bar conveys the strength of the Wifi connection. See About the Status Bar on page 49.

From the Wifi screen, change any of the following options:

www.masimo.com 76 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

Brightness

The slider option adjusts the brightness level of the display and provides a sample of the brightness level.

Level 1 to 4

Battery

From the Battery screen, view the following information:

 Battery icon that conveys remaining battery charge as a green color.  Battery icon that conveys that battery charging status. See About the Status Bar

on page 49.

 Battery time remaining conveyed as a percent value.

See Battery Operation and Maintenance on page 127.

Brightness

From the Brightness screen, change any of the following options:

Access Control

The Access Control screen is protected by a Password screen.

Password Screen

www.masimo.com 77 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Factory Default Settings

User Configurable Settings

All Mute

All patient alarm conditions are silenced. Only system alarms will be indicated by an audible alarm.

Off

On or Off

Lock Alarm Volume

When set to 3 or 4, 3 or 4 shows dimly lit in the Alarm Volume section of the Alarms Menu screen and cannot be changed.

Off

3, 4, or Off

SpO2 Low % Limit

Threshold at which SpO2 Low Alarm Limit cannot be reduced.

Off

1% to 98% in steps of 1, or Off

Lock Layout

Prevents the user from making changes to the parameter layout.

Off

On or Off

Screen Lock

Prevents the user from interacting with the device.

Off

On or Off

Legacy Mode

Changes the Display View from color to simplified monochrome.

Color

Mono or Color

Using the Password screen

1. On the Password screen, enter the following numbers:

6 2 7 4

2. Tap Enter.

3. To undo numbers, tap Backspace.

Access Control Screen

From the Access Control screen, change any of the following options:

www.masimo.com 78 Masimo

Radical-7 Chapter 4: Operation

Save as Adult

Saves pre-configured profiles for adult patients.

N/A

Press Save to load all device configuration settings to adult profile.

Save as Neo

Saves pre-configured profiles for neonatal patients

N/A

Press Save to load all device configuration settings to neonatal profile.

Factory Defaults

Options are restored to factory values.

N/A

Press Restore to return to factory default values.

Options

Description

Factory Default Settings

User Configurable Settings Serial

All serial output is RS-232 based.

ASCII 1

ASCII 1, IAP, HP Vuelink, and SpaceLabs Flexport

Analog 1

An interface with various analog recording instruments and/or strip chart recorders through connector located on Docking Station.

Depending on the configuration, the following parameters are output continuously on the Analog 1 and Analog 2. SpO2 0% to100%

SpO2 50% to 100%, Pulse rate, Pleth, SIQ, 0V Output, 1V Output, SpO2 0% to 100%

Analog 2

Pulse Rate

Pleth, SIQ, 0V Output, 1V Output, SpO2 0% to 100%, SpO2 50% to 100%, or Pulse rate

Nurse Call Trigger

The nurse call output will be activated based on the alarm events. The nurse call with be activated based on Low Signal or Alarm and Low Signal IQ events.

Alarms

Alarms + SIQ, Low SIQ, Alarms

Device Output

From the Device Output screen, change any of the following options:

www.masimo.com 79 Masimo

Radical-7 Chapter 4: Operation

Nurse Call Polarity

Can be inverted to accommodate various nurse call station requirements.

Normal

Normal or Inverted

www.masimo.com 80 Masimo

Radical-7 Chapter 4: Operation

Trends

The following sections describe Trend Views and how to adjust trend settings.

About Trend Views

There are different ways to view trend information. The following is an example of trend information for SpO2 as it appears within the Display View screen.

The following is an example of trend information for SpO2 as it appears in the Full Trend screen.

www.masimo.com 81 Masimo

Radical-7 Chapter 4: Operation

Changing Between Trend Views

To toggle between Display View and Full Trend

From the Display View, in the Trend Field, tap the icon as shown below.

From the Full Trend screen, tap the icon as shown below.

Manipulating Trend Data

To manipulate the view of trend data

On the Full Trend screen, using two fingers, the user can zoom in or zoom out of the trend time scale.

www.masimo.com 82 Masimo

Radical-7 Chapter 4: Operation

The user can add parameters to the trend view by dragging and dropping parameters from the Small Parameter view.

To view past patient trend data, swipe the trend display to the left or to the right.

www.masimo.com 83 Masimo

Radical-7 Chapter 4: Operation

To exit a trend view, press the Home button.

www.masimo.com 84 Masimo

Radical-7 Chapter 4: Operation

Changing Trend Settings

Change the maximum value and the minimum value of the Y axis for any of the available parameters.

To adjust the trend settings for any of the available parameters

1. From the Main Menu screen, tap the Trends icon.

2. From the Trends screen, tap any of the available parameters.

From the Parameter Trends screen, tap the slider for the Y-axis maximum or the Y-axis minimum.The following is an example of the SpO2 Trend screen.

www.masimo.com 85 Masimo

Radical-7 Chapter 4: Operation

4. Select the desired setting by scrolling up or down.

5. When finished, select OK. The following example shows the Y axis range for

SpO2.

www.masimo.com 86 Masimo

Radical-7 Chapter 4: Operation

Options

Description

Serial Number

Displays the serial number of the Handheld.

MCU

Displays the version number of the instrument board software.

MX Board

Displays the version number of the technology level software.

Processor

Displays the version number of the system level software.

Docking Station

If docked, displays the current software version of the Docking Station.

About

From the About screen, access any of the following options:

www.masimo.com 87 Masimo

Chapter 5: Configurations

The Radical-7 can be configured for various patient populations.

About Profiles and Default Settings

The Radical-7 contains a Profiles feature. Profiles are custom settings for different patient populations. These settings can be changed and the Radical-7 remembers the preferred settings after a power cycle. The default settings are settings that are pre-loaded as the device is initially powered on.

There are different ways to access the Profiles settings. The first way is by the tapping the Profiles shortcut that is located in the Status Bar, as show below.

Another way to access Profiles feature is by pressing the Profile button, as shown below.

www.masimo.com 89 Masimo

Radical-7 Chapter 5: Configurations

Options

Description

Factory Default Settings

User Configurable Settings

Patient Type

Defines the patient population for which the device will operate. See About Patient Types on page 92.

Custom

Neonatal, Adult, Custom, or Custom 1 to 5

Sensitivity Modes

Defines the sensitivity level for which the device will operate. See Overview of Sensitivity Modes on page

50.

APOD

MAX, APOD, or NORM

A third way, from the Main Menu screen, is by tapping the Profiles icon.

The Radical-7 stores three types of Profiles:

 Custom (Default)

Any changes to Alarm settings are retained after a power cycle.

 Adult

Any changes to Alarm settings are reset to pre-defined settings. The Adult profile is the default profile after a power cycle.

 Neonatal

Any changes to Alarm settings are reset to pre-defined Neonatal defaults after a power cycle.

After Custom values are changed by the user, the Radical-7 retains these values after a power cycle. The Adult profile and the Neonatal profile can be changed to meet specific hospital or instrument requirements. If the Alarm settings are changed by the user, then these settings return to the instrument default values after it is powered down. A user can also load configurations to the device, which can be enabled by using the Profile button.

Changing Profiles Settings

From the Profiles screen, change any of the following options:

www.masimo.com 90 Masimo

Radical-7 Chapter 5: Configurations

Silence Duration

The amount of time for which the audible part of an alarm will be silenced.

120

30, 60, 90, 120 seconds

Smart Tone

Allows the audible pulse to continue to beep when the pleth graph shows signs of motion.

Off

On or Off

www.masimo.com 91 Masimo

Radical-7 Chapter 5: Configurations

Patient Type

Example of Profile button

Adult (blue) Neonatal (purple)

Custom (colors vary depending on the selected custom setting)

About Patient Types

The Patient Type option defines the patient population for which the device will operate. As a safety measure, one of the ways the Radical-7 conveys the active patient type is by changing the color of the Profiles button. The following lists three examples of patient types and their respective colors.

www.masimo.com 92 Masimo

Radical-7 Chapter 5: Configurations

Powering Off the Radical-7

When turning off the Radical-7, the device remembers the preferred settings.

To turn off the Radical-7

1. Press and hold the button for more than 2 seconds.

2. To confirm the shutdown process, the following screen appears.

www.masimo.com 93 Masimo

Chapter 6: Alarms and Messages

The following chapter contains information about alarms and messages.

For more information, see Chapter 7: Troubleshooting on page 107.

About Alarms

The Radical-7 visually and audibly indicates alarm conditions that the system detects. Audible alarms may be silenced, without affecting the operation of visual alarms. See Safety

Information, Warnings, and Cautions on page 11 and Alarm Related Safety Information, Warnings, and Cautions on page 20.

There are three priorities for alarms:

 High  Medium  Low

Alarm Delay

When an alarm condition is met, this feature delays the audible part of an alarm.

Silencing the Alarms

Alarms are conveyed in ways: audible, visual, or both.

The following is an example of a visual alarm for an exception message:

www.masimo.com 95 Masimo

Radical-7 Chapter 6: Alarms and Messages

The following is an example of a typical alarm.

To silence or dismiss alarms:

 Tap Silence (the highlighted area of the Status Bar).

Audible alarms can be temporarily suspended. With the exception of Sleep mode, there are two audible alarm suspension settings, all controlled by the Alarm Silence button. Repeated pressing of the Alarm Suspend button will cycle through two alarm suspend options.

To silence audible alarms

When an audible is active, push Alarm Silence one time.

1. The audible alarm will be silenced for 120 seconds.

2. Pushing the button a second time restores the previous alarm settings.

www.masimo.com 96 Masimo

Radical-7 Chapter 6: Alarms and Messages

Adaptive Threshold Alarm (ATA) Feature

The Adaptive Threshold Alarm (ATA) feature is an optional feature that provides continuous SpO2 surveillance while allowing the clinician a useful tool to help reduce the frequency of audible alarms.

ATA establishes the alarm limit threshold based upon the patient-specific baseline value of the SpO2 parameter which is determined from the recent history of SpO2 values. An Adaptive Threshold Limit is continuously determined for the patient and SpO2 values outside the Adaptive Threshold Limit trigger an audible alarm. The Adaptive Threshold Limit is bound by the standard SpO2 low alarm limit and the Rapid Desat low alarm limit. SpO2 values that exceed the Rapid Desat limit, whether it occurs rapidly or not, will activate an audible alarm.

Prior to activating ATA, please review and select the appropriate standard low alarm limit and other alarm settings. Once ATA is selected, the Rapid Desat Alarm protection is always active. If the ATA low alarm limit is violated, ATA generates an audible alarm.

It is important to note that once activated, ATA has the following automatic safety features:

Reminder Tones If an SpO2 value from a patient drops below the standard low alarm limit set by the user, a visual alert will display and a reminder tone will repeat every 15 minutes as long as the condition persists. If the SpO2 value drops below the ATA low alarm limit, an audible alarm will be activated.

Rapid Desat Alarm Protection The Rapid Desat feature is always active when ATA is turned on. This means that deep desaturations (5% or 10%) from the standard SpO2 low alarm limit immediately generate an audible alarm. When used with ATA, it also serves as absolute low alarm limit protection. SpO2 values exceeding the Rapid Desat low alarm limit, whether rapid or not, will activate an audible alarm. You can change the Rapid Desat default setting from 5% to 10%. ATA does not allow a Rapid Desat default setting of 0%.

When ATA is turned Off, the instrument uses the standard alarm limits and standard alarm delays.

About Alarms on page 95.

Alarms for SpO2 on page 61.

www.masimo.com 97 Masimo

Radical-7 Chapter 6: Alarms and Messages

3D Alarms

3D Alarms include the Desat Index Alarm and the PI Delta Alarm.

Overview of Desat Index Alarm on page 98.

Overview of Perfusion Index (PI) Delta Alarm on page 99.

Overview of Desat Index Alarm

The Desat Index Alarm is a user-selectable feature which allows a clinician to request an audible and visual alarm if a patient experiences a specified number of desaturations over a specific period of time.

Traditional high and low SpO2 alarm limits alert clinicians to saturation levels that exceed user selected thresholds, and these thresholds are typically established at a considerable

change from the patients’ baseline saturation level. However, in select patient populations,

substantial desaturation events that exceed a typical low alarm limit threshold may be preceded by a cycle of transient desaturations over a limited timeframe, and the ability to alert clinicians to a cycle of these smaller desaturations may provide an earlier indication of a potential significant decline in the patient’s status and the need for more focused monitoring and/or a change in treatment.

To address patient populations at risk for cyclic, moderate desaturations, the option includes a user-selectable Desat Index Alarm which allows the clinician to request an audible and visual alarm in the event the patient experiences a specified number of

desaturations beyond a defined level from the patient’s baseline saturation over a specific

window of time, with each of these variables selectable by the user within established ranges as noted in Desat Index Settings on page 98.

Desat Index Settings

From the Desat Index Settings screen, access the following screens:

Desat Index Alarms on page 99.

Accessing Parameter Information on page 59.

www.masimo.com 98 Masimo

Masimo RAD7CA User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

About this Manual

Product Description, Indications for Use, Contraindications, and Features

Product Description

Key Features

Indications for Use

Contraindications

Safety Information, Warnings, and Cautions

Parameter Related Safety Information, Warnings, and Cautions

Device Related Safety Information, Warnings, and Cautions

Electrical Safety Information, Warnings, and Cautions

Alarm Related Safety Information, Warnings, and Cautions

Sensor Related Safety Information, Warnings, and Cautions

Chapter 1: Technology Overview

Signal Extraction Technology (SET)

Masimo rainbow SET Parallel Engines

Masimo SET DST

General Description for Oxygen Saturation (SpO2)

Successful Monitoring for SpO2, PR, and PI

Functional Oxygen Saturation

General Description for Pulse Rate (BPM)

General Description for Perfusion Index (PI)

General Description for Pleth Variability Index (PVI)

rainbow Pulse CO-Oximetry Technology

Pulse CO-Oximetry vs. Drawn Whole Blood Measurements

General Description for Total Hemoglobin (SpHb)

Successful Monitoring for SpHb

General Description for Total Arterial Oxygen Content (CaO2)

General Description for SpOC

General Description for Carboxyhemoglobin (SpCO)

Successful Monitoring for SpCO

General Description for Methemoglobin (SpMet)

Successful Monitoring for SpMet

SpCO, SpMet, and SpHb Measurements During Patient Motion

rainbow Acoustic Monitoring (RAM) Technology

rainbow Acoustic Monitoring Architecture

Patient

Sensor

Acquisition System

Signal Processing

Chapter 2: Radical-7 Descriptions

General System Description

Functionality of the Radical-7

Handheld

Handheld Front Panel

Handheld Back Panel

Standalone

Standalone Front Panel

Standalone Back Panel

Monitor Interface

Chapter 3: Setup

Unpacking and Inspection

Docking Station Power Requirements

Setting Up the Docking Station

Initial Battery Charging

Setting Up for Philips, Agilent, or HP VueLink

Setting Up for SpaceLabs Flexport

Setting Up and Using SatShare

Chapter 4: Operation

Using the Touchscreen and Buttons

Using Screenlock

Using the Home Button

Navigating the Radical-7

About the Display View

About the Status Bar

Overview of Sensitivity Modes

Changing the Size of Parameter Values

Trend Field

Waveform and Trend Views

Pleth + Siq IQ + Acoustics View

Signal Quality (Sig IQ) Indicators

Pleth + Sig IQ View

RRa Waveform View

Parameter Quick Trend View

Accessing the Main Menu

Navigating the Main Menu

Parameter Settings