Radical-7 Pulse CO-Oximeter Operators Manual March 2020

For Sale in the USA These operating instructions provide the necessary information for proper operation of all models of the Radical-7. 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 Radical-7 are prerequisites for its proper use. Do not operate Radical-7 without completely reading and understanding these instructions. If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer. Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. Wireless Radio: Contains: FCC ID: VFK-RAD7A or VFK-RAD7B | FCC Model: Radical-7 | IC ID: 7362A-RAD7A or 7362A-RAD7B | IC Model: VFK-RAD7A or VFK-RAD7B Masimo Corporation 52 Discovery Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU authorized representative for Masimo Corporation: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

3149433

MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005/A1, CAN/CSA C22.2 No. 60601-1:2014, and applicable Particular (EN/ISO 80601-2-61:2011) and related Collateral (IEC 60601-1-8:2006/AMD1:2012) Standards for which the product has been found to comply by Intertek.

Patents: www.masimo.com/patents.htm Radical-7®, ®, Adaptive Probe Off Detection®, APOD®, 3D Alarm®, Discrete Saturation Transform®, DST®, FastSat®, FST®, Masimo®, Pulse CO-Oximeter®, PVi®, Root®, rainbow®, rainbow Acoustic Monitoring®, rainbow Resposable®, RAM®, RDS®, RRa®, SatShare®, SedLine®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®, and SpMet® are federally registered trademarks of Masimo Corporation. 3D Desat Index Alarm™ and SST™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. The use of the trademark PATIENT SAFETYNET is under license from University HealthSystem Consortium. © 2020 Masimo Corporation www.masimo.com

1

Masimo

Contents About This Manual-------------------------------------------------------------------------------------------7 Product Description, Features and Indications for Use----------------------------------------------- 9 Key Features --------------------------------------------------------------------------------------------- 9 Indications for Use------------------------------------------------------------------------------------- 10 Contraindications -------------------------------------------------------------------------------------- 10 Safety Information, Warnings and Cautions ---------------------------------------------------------- 11 Safety Warnings and Cautions ----------------------------------------------------------------------- 11 Performance Warnings and Cautions --------------------------------------------------------------- 12 Cleaning and Service Warnings and Cautions ---------------------------------------------------- 19 Compliance Warnings and Cautions ---------------------------------------------------------------- 19 Chapter 1: Technology Overview ------------------------------------------------------------------------ 23 Signal Extraction Technology® (SET®) ------------------------------------------------------------ 23 rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 26 rainbow Acoustic Monitoring™ (RAM™) ----------------------------------------------------------- 30 Chapter 2: Description ----------------------------------------------------------------------------------- 33 General System Description ------------------------------------------------------------------------- 33 Functionality of the Radical-7----------------------------------------------------------------------- 33 Handheld ----------------------------------------------------------------------------------------------- 35 Docking Station ---------------------------------------------------------------------------------------- 37 Root------------------------------------------------------------------------------------------------------ 40 Monitor Interface With SatShare -------------------------------------------------------------------- 41 Chapter 3: Setup ------------------------------------------------------------------------------------------- 43 Unpacking and Inspection --------------------------------------------------------------------------- 43 Powering Radical-7 On, Standby, and Power Off -------------------------------------------------- 43 Initial Battery Charging ------------------------------------------------------------------------------- 44 Docking Station Setup -------------------------------------------------------------------------------- 44 Root Setup ---------------------------------------------------------------------------------------------- 45 SatShare Setup and Use ------------------------------------------------------------------------------ 45 Philips, Agilent, or HP VueLink Setup -------------------------------------------------------------- 46 SpaceLabs Flexport Setup ---------------------------------------------------------------------------- 46 Chapter 4: Operation -------------------------------------------------------------------------------------- 49 www.masimo.com

3

Masimo

Radical-7

Contents

Using the Touchscreen and Buttons --------------------------------------------------------------- 49 About the Main Screen ------------------------------------------------------------------------------- 53 Accessing Main Menu Options ---------------------------------------------------------------------- 67 Parameter Settings ------------------------------------------------------------------------------------ 69 Sounds --------------------------------------------------------------------------------------------------- 86 Device Settings ----------------------------------------------------------------------------------------- 86 About----------------------------------------------------------------------------------------------------- 95 Trends---------------------------------------------------------------------------------------------------- 95 Chapter 5: Profiles ----------------------------------------------------------------------------------------- 99 Profiles Overview --------------------------------------------------------------------------------------- 99 Changing Profiles -------------------------------------------------------------------------------------- 99 Profiles Settings -------------------------------------------------------------------------------------- 101 Replacing Factory Default Settings for Adult and Neo Profiles ------------------------------ 102 Chapter 6: Alarms and Messages --------------------------------------------------------------------- 103 About Alarms ----------------------------------------------------------------------------------------- 103 3D Alarms --------------------------------------------------------------------------------------------- 105 Radical-7 Messages -----------------------------------------------------------------------------------107 Chapter 7: Troubleshooting ----------------------------------------------------------------------------- 113 Troubleshooting Measurements-------------------------------------------------------------------- 113 Troubleshooting the Radical-7 --------------------------------------------------------------------- 116 Chapter 8: Specifications ------------------------------------------------------------------------------- 119 Display Range ----------------------------------------------------------------------------------------- 119 Accuracy (ARMS*) ------------------------------------------------------------------------------------ 119 Resolution ---------------------------------------------------------------------------------------------- 121 RRp Performance Specifications ------------------------------------------------------------------- 122 Electrical----------------------------------------------------------------------------------------------- 130 Environmental----------------------------------------------------------------------------------------- 131 Physical Characteristics ----------------------------------------------------------------------------- 131 Trending ----------------------------------------------------------------------------------------------- 132 Alarms ------------------------------------------------------------------------------------------------- 132 Display Indicators------------------------------------------------------------------------------------ 133 Compliance ------------------------------------------------------------------------------------------- 133 Output Interface ------------------------------------------------------------------------------------- 134 www.masimo.com

4

Masimo

Radical-7

Contents

Wireless Specifications------------------------------------------------------------------------------ 137 Guidance and Manufacturer's Declaration-Electromagnetic Emissions -------------------- 140 Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communication Equipment --------------------------------------------------------------------------------------------- 140 Manufacturer's Declaration-Electromagnetic Immunity -------------------------------------- 142 Recommended Separation Distances ------------------------------------------------------------ 144 Symbols ------------------------------------------------------------------------------------------------ 145 Citations ------------------------------------------------------------------------------------------------ 147 Chapter 9: Service and Maintenance----------------------------------------------------------------- 149 Cleaning ----------------------------------------------------------------------------------------------- 149 Battery Operation and Maintenance ------------------------------------------------------------- 149 Replacing the Fuses --------------------------------------------------------------------------------- 151 Performance Verification --------------------------------------------------------------------------- 151 Repair Policy ------------------------------------------------------------------------------------------ 153 Return Procedure------------------------------------------------------------------------------------- 154 Contacting Masimo ---------------------------------------------------------------------------------- 154 Appendix: Concepts of Alarm Response Delay-------------------------------------------------------157 Concepts of Alarm Response Delay ----------------------------------------------------------------157 Index ------------------------------------------------------------------------------------------------------- 159

www.masimo.com

5

Masimo

About This Manual This manual explains how to set up and use Radical-7® Pulse CO-Oximeter®. Important safety information relating to general use of 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 effect, death) to the patient or user. WARNING: This is an example of a warning statement. A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device, or damage to other property. CAUTION: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note.

www.masimo.com

7

Masimo

Product Description, Features and Indications for Use The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi), along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO®), total oxygen content (SpOC), methemoglobin (SpMet), Pleth Variability Index (PVi®), Acoustic Respiration Rate (RRa®), and Pleth Respiration Rate (RRp). The Radical-7 can be used as either a Handheld or a Standalone monitor. The Radical-7 features a touchscreen 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® technology is clinically proven to satisfy all sensitivity and specificity requirements for pulse oximetry.

•

Masimo 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. [The utility of PVi is unknown at this time and requires further clinical studies. Technical factors that may affect PVi include probe malposition and patient motion.]

•

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

•

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 adjacent Radical-7 monitor.

www.masimo.com

9

Masimo

Radical-7 •

Product Description, Features and Indications for Use Automatic screen rotation provides upright display for vertical or horizontal monitor positioning.

•

Multi-gesture touchscreen interface.

•

Detachable portable Handheld for patient transport.

•

Remote alarm interface.

•

Ability to display data on a secondary display.

Indications for Use The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from the pleth (RRp) for adult and pediatrics during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

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

www.masimo.com

10

Masimo

Safety Information, Warnings and Cautions CAUTION: Radical-7 is to be operated by, or under the supervision of, qualified personnel only. Read the manual, accessories directions for use, all precautionary information, and specifications before use. Refer to Operator’s Manuals of Root, Patient SafetyNet and Kite for additional safety information, warnings, and cautions.

Safety Warnings and Cautions WARNING: Do not use the Radical-7 if it appears or is suspected to be damaged. Damage to the device can result in exposed electrical circuits that may cause patient harm. WARNING: Do not adjust, repair, open, disassemble, or modify the Radical-7. Damage to the device may result in degraded performance and/or patient injury. WARNING: Do not start or operate Radical-7 unless the setup was verified to be correct. Improper set-up of this device may result in degraded performance and/or patient injury. WARNING: Do not place the Radical-7 or accessories in any position that might cause it to fall on the patient. WARNING: Only use Masimo authorized devices with Radical-7. Using unauthorized devices with Radical-7 may result in damage to the device and/or patient injury. WARNING: All sensors and cables are designed for use with specific devices. Verify the compatibility of the device, cable, and sensor before use; otherwise degraded performance and/or patient injury can result. WARNING: Do not use the Radical-7 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide to avoid risk of explosion. WARNING: Do not use Radical-7 during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Radical-7 may be used during defibrillation. However, to reduce the risk of electric shock, the operator should not touch the Radical-7 during defibrillation. WARNING: When positioned on a flat surface, the device should be secured with a mounting system recommended by Masimo. WARNING: To reduce the risk of explosion, only replace battery with Masimo supplied parts. WARNING: To protect against injury, follow the directions below: •

Avoid placing the device on surfaces with visible liquid spills.

•

Do not soak or immerse the device in liquids.

•

Do not attempt to sterilize the device.

•

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

•

Do not attempt to clean Radical-7 while monitoring patient.

WARNING: To protect from electric shock, always remove the sensor and completely disconnect Radical-7 before bathing the patient. www.masimo.com

11

Masimo

Radical-7

Safety Information, Warnings and Cautions

WARNING: To ensure safety, avoid placing anything on the device during operation. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. CAUTION: Do not place the Radical-7 where the controls can be changed by the patient. CAUTION: Electric shock hazard: Do not open the Radical-7 cover except to replace the battery or batteries. CAUTION: To ensure patient electrical isolation, only dock to Masimo devices that have been designed for Radical-7. CAUTION: Do not place Radical-7 where the appliance inlet or the AC power plug cannot be readily disconnected. CAUTION: Use a grounded outlet for proper equipment grounding. A hospital-grade outlet is required. CAUTION: To avoid risk of electrical shock, this equipment must only be connected to a supply mains with a protective earth connection. Do not under any circumstances remove the grounding conductor from the power plug. CAUTION: Only use the AC power cable provided by Masimo. Using a different AC power cable could cause damage to Radical Docking Station. Check the power cord and plug to ensure that it is intact and undamaged. CAUTION: To ensure patient electrical isolation, all external device connections to the Data Output/Nurse Call connectors must be IEC 60950-1, IEC 60601-1, or UL1069 compliant. 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: Disconnect the device from AC mains by removing the AC power cord connector from the appliance inlet. Note: Do not monitor more than a single patient at a time on Radical-7. Note: Use and store the Radical-7 in accordance with specifications. See the Specifications chapter in this manual.

Kite WARNING: Do not adjust, repair, open, disassemble, or physically modify the Kite host device. Injury to personnel or equipment damage could occur. Return the Kite host device for servicing.

Performance Warnings and Cautions WARNING: Radical-7 should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: The Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. www.masimo.com

12

Masimo

Radical-7

Safety Information, Warnings and Cautions

WARNING: If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check Radical-7 for proper functioning. WARNING: 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 data, Radical-7 trend data should be scrutinized in light of a specific patient condition. Any results exhibiting inconsistency with the patient's clinical status should be repeated and/or supplemented with additional data. WARNING: Do not use Radical-7 as an apnea monitor. Radical-7 does not have alarms to alert you when you are not breathing properly. WARNING: Radical-7 should not be used used as a replacement or substitute for ECG-based arrhythmia analysis. WARNING: Radical-7 may be used during defibrillation; however, the display may require up to 15 seconds to return to normal operation. WARNING: Radical-7 may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements. WARNING: Radical-7 may be used during electrocautery, but this may affect the accuracy or availability of the parameters and measurements. WARNING: Avoid placing Radical-7 against a surface that may cause the alarm to be muffled. This may result in the inability to detect the audible alarms. WARNING: Radical-7 may not fully charge in a high ambient temperature environment. WARNING: Do not place containers with liquids on or near Radical-7. Liquids spilled on Radical-7 may cause it to perform inaccurately or fail. WARNING: Properly apply sensors according to sensor's directions for use. Misapplied sensor or sensors that become partially dislodged may cause no or incorrect readings. WARNING: Select a well perfused site for monitoring, very low perfusion at the monitored site may result in no or incorrect readings. WARNING: Do not use Radical-7 on patients that have been injected with dyes or any substance containing dyes, the change usual blood pigmentation may cause no or incorrect readings. WARNING: Display parameter may not be accurate when a low SIQ message is provided. Clinicians should consider additional information to supplement values to completely understand the patient’s condition. WARNING: If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. WARNING: SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). WARNING: Optical, pleth-based measurements (e.g. SpO2, SpHb, SpOC, SpMet, SpCO, and RRp) can be affected by the following: •

Improper sensor application or use of use of incorrect sensor.

•

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

•

Intravascular dyes such as indocyanine green or methylene blue.

•

Venous congestion.

www.masimo.com

13

Masimo

Radical-7

Safety Information, Warnings and Cautions

•

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

•

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

•

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

•

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

•

Elevated levels of bilirubin.

•

Physiological conditions that can significantly shift the oxygen disassociation curve.

•

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

•

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

WARNING: No or inaccurate SpO2 readings may be caused by: •

Improper sensor application.

•

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

•

Arterial catheter

•

Elevated levels of COHb and/or MetHb. Note: High levels of COHb or MetHb may occur with a seemingly normal SpO2.

•

Intravascular dyes such as indocyanine green or methylene blue.

•

Venous congestion.

•

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

•

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

•

Moisture, birthmarks, skin discoloration, or foreign objects in the light path.

•

Elevated levels of bilirubin.

•

Severe anemia.

•

Very low arterial perfusion.

•

Hypocapnic or Hypercapnic conditions.

•

Excessive motion.

•

Vasospastic disease such as Raynaud's.

•

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

•

Peripheral vascular disease.

•

EMI radiation interference.

WARNING: Inaccurate SpHb and SpOC readings may be caused by: •

Intravascular dyes, such as indocyanine green or methylene blue.

www.masimo.com

14

Masimo

Radical-7

Safety Information, Warnings and Cautions

•

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

•

Elevated PaO2 levels.

•

Elevated levels of bilirubin.

•

Low arterial perfusion.

•

Motion artifact.

•

Low arterial oxygen saturation levels.

•

Elevated COHb and/or MetHb levels.

•

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

•

Vasospastic disease such as Raynaud's.

•

Peripheral vascular disease.

•

Liver disease.

•

EMI radiation interference.

WARNING: Inaccurate SpCO and SpMet readings may be caused by: •

Improper sensor application.

•

Intravascular dyes such as indocyanine green or methylene blue.

•

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

•

Elevated PaO2 levels.

•

Elevated methemoglobin levels.

•

Abnormal hemoglobin levels.

•

Low arterial perfusion.

•

Low arterial oxygen saturation levels including altitude induced hypoxemia.

•

Elevated total bilirubin levels.

•

Motion artifact.

•

Vasospastic disease such as Raynaud's.

•

Peripheral vascular disease.

•

Liver disease.

•

EMI radiation interference.

WARNING: SpCO readings may not be provided if there are Low arterial oxygen saturation levels or elevated methemoglobin levels. WARNING: Inaccurate RRa measurements may be caused by: •

Improper sensor application or use of incorrect sensor.

•

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

www.masimo.com

15

Masimo

Radical-7

Safety Information, Warnings and Cautions

•

Motion artifact.

•

Excessive ambient or environmental noise.

WARNING: Inaccurate RRp measurements may be caused by: •

Low arterial perfusion.

•

Motion induced artifact.

•

Severe anemia.

•

Arrhythmia

WARNING: Wireless communication of alarms to a secondary monitoring station should not be relied upon as a primary alarm. WARNING: A functional tester cannot be used to assess the accuracy of the Radical-7. CAUTION: The RRp value may be inaccurate under conditions where the pulse rate is less than two times the respiration rate. The following conditions may include, but it’s not limited to: patients with high respiration rate and low heart rate, or patients with specific medical conditions such as sick sinus syndrome, bradycardia due to any primary cardiac conditions as well as secondary condition from beta blockers, digoxin etc. CAUTION: Respiration rate provides an indicator of central ventilatory drive and not a direct indication that air is moving through the upper airway. CAUTION: If using 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 device might read zero for the duration of the active irradiation period. CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy. CAUTION: The device must be configured to match your local power line frequency to allow for the cancelation of noise introduced by fluorescent lights and other sources. CAUTION: High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor. CAUTION: To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate measurements. CAUTION: For home use, ensure that the Radical-7 alarm can be heard from other rooms in the house, especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios are operating. CAUTION: When Silence Duration is set to All Mute or All Mute with Reminder on Radical-7, there will be no audible alarms on Radical-7 or Patient SafetyNet; however, there will be visual alarms displayed on Radical-7 and Patient SafetyNet view. CAUTION: If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Radical-7. www.masimo.com

16

Masimo

Radical-7

Safety Information, Warnings and Cautions

CAUTION: Do not place the Radical-7 on electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Radical-7 promptly after a Low Battery alarm may result in the device shutting down. CAUTION: To minimize electromagnetic interference, only use a SatShare cable that has a ferrite bead installed. CAUTION: During SatShare operation, alarms may be muted on the Radical-7. Use the multi-parameter monitor for audible alarms during SatShare operation. CAUTION: Ensure Radical Docking Station is connected to AC power source when charging Radical-7. CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer. CAUTION: In order to establish and maintain Radical-7’s minimum Quality of Service, the following network specifications should be met before and after installation: •

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

•

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

CAUTION: The wireless quality of services may be influenced by the presence of other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID, MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices, consideration should be taken to maximize separation distances and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength. CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time the Radical-7 is used. CAUTION: Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently displayed while monitoring consecutive patients after completing the low SIQ troubleshooting steps listed in the troubleshooting section. Note: Cables and sensors are provided with X-Cal® technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of patient monitoring time. Note: If the Radical-7 stops communicating with Root, parameters and measurements will not show on the Root display; however, this will not affect Radical-7's ability to monitor the patient. Note: It is recommended that Radical-7 battery is fully charged prior to use. Note: Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling. www.masimo.com

17

Masimo

Radical-7

Safety Information, Warnings and Cautions

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: Physiological conditions that result in loss of pulsatile signal may result in no PaO2, SpHb, SpOC, SpCO, SpMet, and RRp readings. Note: Radical-7 is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication. Note: Radical-7’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Radical-7’s primary alarms. Note: Always charge Radical-7 when it is not in use to ensure that the Radical-7 battery remains fully charged. Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the Battery Module. Note: The 3D Desat Index™ alarm is intended as an adjunct alarm rather than in place of the Low SpO2 alarm. Note: When monitoring acoustic respiration, Masimo recommends minimally monitoring both oxygenation (SpO2) and respiration (RRa). 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. 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.

Kite WARNING: Kite does not generate or manage alarms. The connected device's alarms, used in conjunction with clinical signs and symptoms, are the primary sources for determining that an alarm condition exists. CAUTION: Kite is not a primary display. Medical decisions should be made using data from the primary display of a device in conjunction with clinical signs and symptoms. CAUTION: Kite is intended to operate across the facility's network. Unanticipated failure or alteration of network components (including but not limited to: disconnection or malfunctioning of a networking device/switch/router/ethernet cable) may result in loss of connectivity of Kite to other hospital systems. Altering or making changes to the hospital network should be done with proper knowledge.

Patient SafetyNet Note: The wireless communication status between Radical-7 and Patient SafetyNet is displayed by Patient SafetyNet.

www.masimo.com

18

Masimo

Radical-7

Safety Information, Warnings and Cautions

Cleaning and Service Warnings and Cautions WARNING: Do not attempt to remanufacture, recondition or recycle the Radical-7 as these processes may damage the electrical components, potentially leading to patient harm. WARNING: To avoid electric shock, always turn off the Radical-7 and physically disconnect the AC power and all patient connections before cleaning. WARNING: Electrical Shock Hazard: The battery should be installed and/or removed from the Radical-7 by qualified personnel only. WARNING: Do not incinerate the Radical-7 Battery. The battery should be properly disposed according to local laws and regulations. WARNING: Fire Hazard: To protect against fire hazard, on docking station replace only with fuses of same type, current rating, and voltage rating. WARNING: Electrical Shock Hazard: The Docking Station battery if provided should be installed and/or removed from the Docking Station only by qualified personnel. CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the Radical-7 for servicing. CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the display. CAUTION: To avoid permanent damage to the Radical-7, do not use undiluted bleach (5% 5.25% sodium hypochlorite) or any other cleaning solution not recommended. CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Radical-7. These substances affect the device’s materials and device failure can result. CAUTION: Do not submerge Radical-7 in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage Radical-7. CAUTION: To prevent damage, do not soak or immerse Radical-7 in any liquid solution. CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-applied circuits and the system are within acceptable limits as specified by the applicable safety standards. The summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting external equipment to the system. When an event such as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur.

Compliance Warnings and Cautions WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. CAUTION: Dispose of used batteries according to required country or regional instructions.

www.masimo.com

19

Masimo

Radical-7

Safety Information, Warnings and Cautions

CAUTION: Disposal of product: Comply with local laws in the disposal of the device and/or its accessories. CAUTION: External device connections to the SatShare port must be IEC-60601-1 compliant. Note: Cleared Use Only: The device and related accessories have obtained CE Mark for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the instructions for use or labeling. Note: Use Radical-7 in accordance with the Environmental Specifications section in the Operator's Manual. Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: •

Reorient or relocate the receiving antenna.

•

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.

Note: This equipment has been tested and found to comply with the Class B limits for medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments. Note: In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and TV reception. The user is cautioned that changes and modifications made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment. Note: To satisfy RF exposure requirements, this device and its antenna must operate with a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. Note: This Class B digital apparatus complies with Canadian ICES-003. Note: This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

www.masimo.com

20

Masimo

Radical-7

Safety Information, Warnings and Cautions

Note: Users are advised that high-power radars are allocated as primary users (i.e. priority users) of the bands 5.25-5.35 GHz and 5.65-5.85 GHz and that these radars could cause interference and/or damage to LE-LAN devices. Note: In accordance with FCC requirements, radio accessories on Radical-7 cannot be attached directly to the patient using any accessory containing metal components. Note: Change or modifications that are not expressly approved by the manufacturer could void the user’s authority to operate the equipment.

www.masimo.com

21

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 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