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Rad-97
Operator's Manual
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Masimo Rad-97 Operator's Manual

Operator's Manual
Rad-97™ Pulse CO-Oximeter
®
Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures, experiments, or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the directions for use or labeling.
Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings and precautions.
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions.
Wireless Radio Contains: FCC ID: VKF-MWM1 | Model: Rad-97 | IC: 7362A- MWM1 | IC Model: MWM1
Masimo Corporation 40 Parker Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005,CAN/CSA C22.2 No. 60601-1:2008, and
3149433
applicable Particular (EN/ISO 80601-2-61:2011) and related Collateral (IEC
60601-1-8:2006) Standards for which the product has been found to comply by
Intertek.
Patents: www.masimo.com/patents.htm
®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, Masimo®, Pulse CO-Oximeter®, PVi®, rainbow®, rainbow Resposable®, RRa®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®, and SpMet® are federally registered trademarks of Masimo Corporation.
Rad-97™, rainbow Acoustic Monitoring™, rainbow SET™, RAM™, Adaptive Threshold Alarm™, In Vivo Adjustment™, ORi™, X-Cal™, Kite™, SpOC™, and RRp™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective
www.masimo.com 1 Masimo
owners. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
All other registered trademarks and trademarks are property of their respective owners.
© 2017 Masimo Corporation
www.masimo.com 2 Masimo
Contents
About This Manual-------------------------------------------------------------------------------------------7
Product Description, Features and Indications for Use ----------------------------------------------- 9
Product Description ------------------------------------------------------------------------------------- 9
Indications for Use ------------------------------------------------------------------------------------- 10
Contraindications -------------------------------------------------------------------------------------- 11
Safety Information, Warnings and Cautions ---------------------------------------------------------- 13
Safety Warnings and Cautions ----------------------------------------------------------------------- 13
Performance Warnings and Cautions --------------------------------------------------------------- 15
Cleaning and Service Warnings and Cautions --------------------------------------------------- 20
Compliance Warnings and Cautions ---------------------------------------------------------------- 21
Chapter 1: Technology Overview ------------------------------------------------------------------------ 23
Signal Extraction Technology® (SET®) ------------------------------------------------------------ 23
rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 26
rainbow Acoustic Monitoring™ (RAM™) ------------------------------------------------------------ 31
Chapter 2: Description ----------------------------------------------------------------------------------- 35
General System Description ------------------------------------------------------------------------- 35
Features ------------------------------------------------------------------------------------------------- 36
Chapter 3: Setting Up------------------------------------------------------------------------------------ 39
Unpacking and Inspection -------------------------------------------------------------------------- 39
Preparation for Use ----------------------------------------------------------------------------------- 39
Guidelines for Setting Up ---------------------------------------------------------------------------- 39
Powering the Rad-97 ON and OFF ------------------------------------------------------------------ 40
Initial Battery Charging ------------------------------------------------------------------------------- 41
Nurse Call Connection -------------------------------------------------------------------------------- 41
Attach NIBP Cuff --------------------------------------------------------------------------------------- 42
Masimo Kite --------------------------------------------------------------------------------------------- 42
Third-Party Devices ------------------------------------------------------------------------------------ 42
Chapter 4: Operation -------------------------------------------------------------------------------------- 43
Using the Touchscreen and Home Button --------------------------------------------------------- 43
About the Main Screen --------------------------------------------------------------------------------48
About the System Status Light --------------------------------------------------------------------- 56
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Rad-97 Contents
Accessing Main Menu Options ---------------------------------------------------------------------- 57
Parameter Settings ----------------------------------------------------------------------------------- 60
Noninvasive Blood Pressure (NIBP) Settings ---------------------------------------------------- 80
Sounds --------------------------------------------------------------------------------------------------- 85
Device Settings ----------------------------------------------------------------------------------------- 86
About ----------------------------------------------------------------------------------------------------- 97
Trends ---------------------------------------------------------------------------------------------------- 97
Rad-97 Screenshot Capture -------------------------------------------------------------------------- 99
Patient Admit/Discharge --------------------------------------------------------------------------- 101
Chapter 5: Profiles --------------------------------------------------------------------------------------- 103
Profiles Overview ------------------------------------------------------------------------------------- 103
Changing Profiles ------------------------------------------------------------------------------------ 103
Profiles Settings -------------------------------------------------------------------------------------- 106
Replacing Factory Default Settings for Adult, Pediatric and Neonatal Profiles ------------107
Chapter 6: Noninvasive Blood Pressure (NIBP) ---------------------------------------------------- 109
Operation - NIBP ------------------------------------------------------------------------------------- 109
Patient Category ------------------------------------------------------------------------------------- 109
Patient Conditions ----------------------------------------------------------------------------------- 109
Cuff Selection and Placement --------------------------------------------------------------------- 110
Blood Pressure Measurement ----------------------------------------------------------------------- 112
Chapter 7: Admit to and Discharge from Patient SafetyNet -------------------------------------- 117
Not Admitted ------------------------------------------------------------------------------------------ 117
Admitting a Patient ---------------------------------------------------------------------------------- 118
Discharging a Patient ------------------------------------------------------------------------------- 120
Chapter 8: Third-Party Devices ------------------------------------------------------------------------- 121
Connect Device to Rad-97 --------------------------------------------------------------------------- 121
Chapter 9: Alarms and Messages --------------------------------------------------------------------- 123
Alarm Interface --------------------------------------------------------------------------------------- 123
About Alarms ------------------------------------------------------------------------------------------ 124
Adaptive Threshold Alarm (ATA) Feature -------------------------------------------------------- 127
3D Alarms --------------------------------------------------------------------------------------------- 128
Messages ---------------------------------------------------------------------------------------------- 130
Noninvasive Blood Pressure (NIBP) Messages ------------------------------------------------- 135
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Rad-97 Contents
Chapter 10: Troubleshooting -------------------------------------------------------------------------- 137
Troubleshooting Measurements ------------------------------------------------------------------- 137
Troubleshooting Rad-97 ---------------------------------------------------------------------------- 140
Chapter 11: Specifications ------------------------------------------------------------------------------ 145
Pulse CO-Oximetry Specifications ----------------------------------------------------------------- 145
Noninvasive Blood Pressure (NIBP) Specifications -------------------------------------------- 150
Electrical ----------------------------------------------------------------------------------------------- 151
Environmental ---------------------------------------------------------------------------------------- 152
Physical Characteristics ----------------------------------------------------------------------------- 152
Alarms -------------------------------------------------------------------------------------------------- 153
Display Indicators ------------------------------------------------------------------------------------ 153
Compliance -------------------------------------------------------------------------------------------- 154
Connectors -------------------------------------------------------------------------------------------- 155
Wireless Specifications------------------------------------------------------------------------------ 155
Guidance and Manufacturer's Declaration-Electromagnetic Emissions -------------------- 158
Guidance and Manufacturer's Declaration-Electromagnetic Immunity -------------------- 158
Recommended Separation Distances ------------------------------------------------------------ 161
Symbols ------------------------------------------------------------------------------------------------ 162
Citations ----------------------------------------------------------------------------------------------- 164
Chapter 12: Service and Maintenance --------------------------------------------------------------- 167
Cleaning ----------------------------------------------------------------------------------------------- 167
Nurse Call Setting Connections ------------------------------------------------------------------- 167
Performance Verification --------------------------------------------------------------------------- 168
Calibration -------------------------------------------------------------------------------------------- 170
Maintenance ------------------------------------------------------------------------------------------- 172
Repair Policy ------------------------------------------------------------------------------------------ 173
Return Procedure ------------------------------------------------------------------------------------- 173
Contacting Masimo ---------------------------------------------------------------------------------- 173
Appendix: Concepts of Alarm Response Delay ------------------------------------------------------- 177
Concepts of Alarm Response Delay ---------------------------------------------------------------- 177
Index ------------------------------------------------------------------------------------------------------- 179
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About This Manual

This manual explains how to set up and use Rad-97™ Pulse CO-Oximeter®. Important safety information relating to general use of Rad-97 appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.
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Product Description, Features and Indications for Use

Product Description

Rad-97™ Pulse CO-Oximeter® is a non-invasive device intended to monitor functional oxygen saturation of arterial hemoglobin (SpO Variability Index (PVi) along with optional non-invasive measurements of total hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), Acoustic Respiration Rate (RRa), Oxygen Reserve Index (ORi)*, and Pleth Respiration Rate (RRp)*.
The following key features are available for Rad-97:
• Masimo SET and rainbow SET technology performance.
• SpO
• Continuous and non-invasive monitoring of carboxyhemoglobin (SpCO),
• Respiration Rate (RR) is measured using:
• Oxygen Reserve Index (ORi)*, an index to measure changes in oxygen states under
• Wireless radio for transfer of parameter data.
• Sleep Study and optional Home operational modes.
• Optional integrated Noninvasive Blood Pressure (NIBP) technology.
• Designed for third party measurement expansion to allow for additional platform
• Ability to display data on a secondary display.
For all prescribing information and instructions for use of the compatible medical devices connected to Rad-97, see the Operator's Manual or Instructions for Use for the specific medical device.
* Currently not available in the U.S.A. and territories relying on FDA market clearance.
and pulse rate monitoring in motion and low perfusion environments.
2
methemoglobin (SpMet), and total hemoglobin (SpHb).
• Acoustic (RRa)
• Plethysmographic waveform (RRp)*
hyperoxic conditions.
measurements.
), pulse rate (PR), perfusion index (Pi), and Pleth
2

Regulatory Notice

The following features are NOT AVAILABLE.
Feature NOT AVAILABLE in U.S.A. and territories relying on FDA market clearance
SpO2
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Rad-97 Product Description, Features and Indications for Use
Feature NOT AVAILABLE in U.S.A. and territories relying on FDA market clearance
PR
Pi
PVi
SpHb
SpCO
SpOC
SpMet
RRa
RRp X
ORi X
ATA X
In-Vivo X
NIBP

Indications for Use

The Masimo Rad-97 and Accessories are indicated for hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rad-97 and Accessories 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 addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO those devices.
) and pulse rate (PR) to multi-parameter devices for the display on
2
The Masimo Rad-97 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
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), pulse rate (PR),
2
Rad-97 Product Description, Features and Indications for Use
intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The optional Nomoline Capnography product family is intended to be connected to other medical backboard devices for monitoring of breath rate and CO Capnography product family is intended to be connected to a patient breathing circuit for
. The Nomoline
2
monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient room. The intended patient population is adult, pediatric and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NIBP module is designed to measure blood pressure for patient population described in the following table:
Patient Population Approximate Age Range
Newborn (neonate) Birth to 1 month of age
Infant 1 month to 2 years of age
Child 2 to 12 years of age
Adolescent 12-21 years of age
Adult 21 years of age and older

Contraindications

The Rad-97 is not intended for use as an apnea monitor.
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Safety Information, Warnings and Cautions

CAUTION: Rad-97 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 Patient SafetyNet and Kite for additional safety information, warnings, and cautions.

Safety Warnings and Cautions

WARNING: Do not use Rad-97 if it appears or is suspected to be damaged. Damage to the device can result in exposed electrical circuits that may cause patient harm.
WARNING: Do not adjust, repair, open, disassemble, or modify the Rad-97. Damage to the device may result in degraded performance and/or patient injury.
WARNING: Do not start or operate the Rad-97 unless the setup was verified to be correct. Improper set-up of this device may result in degraded performance and/or patient injury.
WARNING: Do not place the Rad-97 or accessories in any position that might cause it to fall on the patient.
WARNING: Only use Masimo authorized devices with Rad-97. Using unauthorized devices with Rad-97 may result in damage to the device and/or patient injury.
WARNING: All sensors and cables are designed for use with specific devices. Verify the compatibility of the device, cable, and sensor before use; otherwise degraded performance and/or patient injury can result.
WARNING: Do not use the Rad-97 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide to avoid risk of explosion.
WARNING: Do not use the Rad-97 during magnetic resonance imaging (MRI) or in an MRI environment.
WARNING: Rad-97 may be used during defibrillation. However, to reduce the risk of electric shock, the operator should not touch the Rad-97 during defibrillation.
WARNING: Electrical Shock Hazard: 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 the Rad-97 while monitoring patient.
WARNING: To ensure safety, avoid placing anything on the device during operation.
WARNING: As with all medical equipment, carefully route patient cables to reduce the
possibility of patient entanglement or strangulation.
CAUTION: Do not place the Rad-97 where the controls can be changed by the patient.
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Rad-97 Safety Information, Warnings and Cautions
CAUTION: Do not place Rad-97 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 Rad-97. 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 Rad-97 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 Rad-97.
Note: Use and store the Rad-97 in accordance with specifications. See the Specifications
section in this manual.

Noninvasive Blood Pressure

WARNING: Only use Rad-97 in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates.
WARNING: Neonatal blood pressure measurements must always use a 3 meter hose in order to avoid overpressure error caused by lack of air volume within the overall pneumatic system.
WARNING: Frequently check the blood pressure monitoring site to ensure adequate circulation.
WARNING: Do not apply the cuff to a limb that is on the same side of a mastectomy.
WARNING: Do not use or stop blood pressure measurements if the patient appears to be
affected by the pressurization of the cuff due to a physical condition (i.e. pregnant, pre-eclamptic, etc.)
WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference.
WARNING: Do not attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arterio-venous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient.
CAUTION: Applying the blood pressure cuff over a wound can cause further injury.
CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure
resulting in blood flow interference and potentially harmful injury to the patient.
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Rad-97 Safety Information, Warnings and Cautions

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: Rad-97 should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms.
WARNING: The Rad-97 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.
WARNING: If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check Rad-97 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, Rad-97 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: Rad-97 is not an apnea monitor.
WARNING: Rad-97 should not be used as a replacement or substitute for ECG-based
arrhythmia analysis.
WARNING: Rad-97 may be used during defibrillation. This may affect the accuracy or availability of the parameters and measurements.
WARNING: Rad-97 may be used during electrocautery. This may affect the accuracy or availability of the parameters and measurements.
WARNING: Avoid placing Rad-97 against a surface that may cause the alarm to be muffled. This may result in the inability to detect the audible alarms.
WARNING: Rad-97 may not fully charge in a high ambient temperature environment.
WARNING: Properly apply sensors according to sensor's directions for use. Misapplied sensor
or sensors that become partially dislodged may cause no or incorrect readings.
WARNING: Select a well perfused site for monitoring, very low perfusion at the monitored site may result in no or incorrect readings.
WARNING: Do not use Rad-97 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.
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Rad-97 Safety Information, Warnings and Cautions
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. SpO and ORi) can be affected by the following:
, SpHb, SpOC, SpMet, SpCO, RRp,
2
• 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.
• 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.
WARNING: Inaccurate SpO
readings may be caused by:
2
• Elevated levels of COHb and/or MetHb.
• Severe anemia.
• Extremely low arterial perfusion.
• Excessive induced motion.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (Quantitative defects such as Thalassemias).
WARNING: Inaccurate SpHb and SpOC readings may be caused by:
• Low arterial perfusion.
• Motion induced artifact.
• Low arterial oxygen saturation levels.
• Elevated COHb and/or MetHb levels.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (quantitative defects such as Thalassemias).
• Severe anemia.
WARNING: Inaccurate SpCO readings may be caused by:
• Elevated methemoglobin levels in the range of >15%.
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Rad-97 Safety Information, Warnings and Cautions
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias).
• Extremely elevated hemoglobin levels.
• Low arterial perfusion.
• Low arterial oxygen saturation levels including altitude induced hypoxemia.
• Motion induced artifact.
• Severe anemia.
WARNING: SpCO readings may not be provided if there are Low arterial oxygen saturation levels or elevated methemoglobin levels.
WARNING: Inaccurate SpMet readings may be caused by:
• Elevated carboxyhemoglobin levels in the range of > 3%.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (quantitative defects such as Thalassemias).
• Extremely elevated hemoglobin levels.
• Low arterial perfusion.
• Low arterial oxygen saturation levels including altitude induced hypoxemia.
• Motion induced artifact.
• Physiological conditions that can significantly shift the oxygen disassociation
curve.
• Severe anemia.
WARNING: Inaccurate RRa measurements may be caused by:
• Improper sensor application or use of use of incorrect sensor.
• Abnormal pulse rhythms due to physiological conditions or induced through
external factors (e.g. Cardiac arrhythmias, intra-aortic balloon, etc.).
• Motion artifact.
• Excessive ambient or environmental noise.
WARNING: Inaccurate RRp readings may be caused by:
• Low arterial perfusion.
• Motion induced artifact.
• Severe anemia.
WARNING: Inaccurate ORi readings may be caused by:
• Low arterial perfusion.
• Motion induced artifact.
• Elevated COHb and/or MetHb levels.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (Quantitative defects such as Thalassemias).
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Rad-97 Safety Information, Warnings and Cautions
• Hypotension, severe vasoconstriction, severe anemia, or hypothermia.
WARNING: ORi is not intended as a replacement for SpO2 monitoring, PaO2 monitoring, or as a sole indicator of the patient condition.
WARNING: Wireless communication of alarms to a secondary monitoring station should not be relied upon as a primary alarm.
CAUTION: ORi may not indicate additional changes in oxygen states above 200 mmHg of
.
PaO
2
CAUTION: If using Rad-97 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: 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: If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means.
CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Rad-97.
CAUTION: Do not place the Rad-97 near electrical equipment that may affect the device, preventing it from working properly.
CAUTION: Failure to charge Rad-97 promptly after a Low Battery alarm may result in the device shutting down.
CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer.
CAUTION: In order to establish and maintain Rad-97’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,
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Rad-97 Safety Information, Warnings and Cautions
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 Rad-97 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: SpHb readings may be inaccurate for patients with conditions that may cause edema at the measurement site (eg. kidney disease, pregnancy, etc.).
Note: Physiological conditions that result in loss of pulsatile signal may result in no SpO SpHb, SpOC, SpCO, SpMet, RRp, and ORi readings.
,
2
Note: Rad-97 is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication.
Note: Rad-97’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Rad-97's primary alarms.
Note: Always charge Rad-97 when it is not in use to ensure that the Rad-97 Battery Module remains fully charged.
Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the Battery Module.
Note: A functional tester cannot be used to assess the accuracy of Rad-97.
Note: When monitoring acoustic respiration, Masimo recommends minimally monitoring
both oxygenation (SpO
) and respiration (RRa).
2
Note: When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be compromised. If the Rad-97 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.

Noninvasive Blood Pressure

WARNING: Before applying the cuff on the patient, confirm the cuff size is appropriate.
WARNING: When a blood pressure measurement error code occurs, any blood pressure values
reported should be disregarded.
CAUTION: If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse oximeter probe), the pressurization within the cuff can cause temporary loss of function of the monitoring equipment.
CAUTION: Blood pressure measurements can be affected by the patient's position, physiological condition, and environmental factors.
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Rad-97 Safety Information, Warnings and Cautions
Note: Physiological conditions that can affect blood pressure measurements include, but are not limited to, cardiac arrhythmias, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, trembling, and shivering.

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. All medical decisions should be made using data on the connected Masimo medical device primary display.
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 Rad-97 and Patient SafetyNet is displayed by Patient SafetyNet.

Cleaning and Service Warnings and Cautions

WARNING: Do not attempt to remanufacture, recondition or recycle the Rad-97 as these processes may damage the electrical components, potentially leading to patient harm.
WARNING: To avoid electric shock, always turn off the Rad-97 and physically disconnect the AC power and all patient connections before cleaning.
WARNING: To avoid electric shock, do not attempt to replace or remove the Battery from the Rad-97. Service of Rad-97 should be done by qualified personnel only.
WARNING: Do not incinerate the Rad-97 Battery. The battery should be properly disposed according to local laws and regulations.
CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the Rad-97 for servicing.
CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the display.
CAUTION: To avoid permanent damage to the Rad-97, do not use undiluted bleach (5% -
5.25% sodium hypochlorite) or any other cleaning solution not recommended.
CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Rad-97. These substances affect the device’s materials and device failure can result.
CAUTION: Do not submerge the Rad-97 in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device.
CAUTION: To prevent damage, do not soak or immerse Rad-97 in any liquid solution.
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Rad-97 Safety Information, Warnings and Cautions
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: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories.
CAUTION: Device contains an internal battery. Dispose of the battery according to required country or regional requirements.
Note: Use Rad-97 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
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Rad-97 Safety Information, Warnings and Cautions
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 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 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 (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.
®
pulse oximetry utilizes parallel engines and adaptive filtering. Adaptive filters
®
signal processing algorithm, Discrete Saturation Transform
®
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Rad-97 Chapter 1: Technology Overview

Masimo SET® DST

This figure is for conceptual purposes only.

General Description for Oxygen Saturation (SpO2)

Pulse oximetry is governed by the following principles:
1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (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.
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.
Functional Oxygen Saturation (SpO2)
The Rad-97 is calibrated to measure and display functional oxygen saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen.
Note: Dyshemoglobins are not capable of transporting oxygen, but are recognized as oxygenated hemoglobins by conventional pulse oximetry.
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Rad-97 Chapter 1: Technology Overview

General Description for Pulse Rate (PR)

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

General Description for Perfusion Index (Pi)

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

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%).
PVi may show changes that reflect physiological factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions.
The utility of PVi has been evaluated in clinical studies [1-11]. Technical and clinical factors that may affect PVi include probe malposition, probe site, patient motion, skin incision, spontaneous breathing activity, lung compliance, open pericardium, use of vasopressors or vasodilators, low perfusion index, subject age, arrhythmias, left or right heart failure, and tidal volume [12-14].
Citations for Pleth Variability Index (PVi)
1. Cannesson M., Desebbe O., Rosamel P., Delannoy B., Robin J., Bastien O., Lehot J.J.
Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008 Aug;101(2):200-6.
2. Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse
Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg. 2010 Oct;111(4):910-4.
3. Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B.M., Wiesenack C.
Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. Anesth Analg. The
Ability of Pleth Variability Index to Predict the Hemodynamic Effects of Positive End-Expiratory Pressure in Mechanically Ventilated Patients under General Anesthesia. 2010 Mar 1;110(3):792-8.
5. Tsuchiya M., Yamada T., Asada A. Pleth Variability Index Predicts Hypotension
During Anesthesia Induction. Acta Anesthesiol Scand. 2010 May;54(5):596-602.
6. Loupec T., Nanadoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene
B., Dahyot-Fizelier C., Mimoz O. Pleth Variability Index Predicts Fluid Responsiveness in Critically Ill Patients. Crit Care Med. 2011 Feb;39(2):294-9.
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Rad-97 Chapter 1: Technology Overview
7. Fu Q., Mi W.D., Zhang H. Stroke Volume Variation and Pleth Variability Index to
Predict Fluid Responsiveness during Resection of Primary Retroperitoneal Tumors in Hans Chinese. Biosci Trends. 2012 Feb;6(1):38-43.
8. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. Anesth. 2012 Oct;26(5):696-701.
9. Byon H.J., Lim C.W., Lee J.H., Park Y. H., Kim H.S., Kim C.S., Kim J.T. Br. J.
Prediction of fluid Responsiveness in Mechanically Ventilated Children Undergoing
Neurosurgery. Anaesth 2013 Apr;110(4):586-91.
10. Feissel M., Kalakhy R., Banwarth P., Badie J., Pavon A., Faller J.P., Quenot JP.
Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 2013 Oct;28(5):634-9.
11. Yu Y., Dong J., Xu Z., Shen H., Zheng J. Pleth Variability Index-Directed Fluid Management in Abdominal Surgery under Combined General and Epidural Anesthesia. J Clin Monit Comput. 2014 Feb 21.
12. Desgranges F.P., Desebbe O., Ghazouani A., Gilbert K., Keller G., Chiari P., Robin J.,Bastien O., Lehot J.J., Cannesson M. Br. J. Anaesth 2011 Sep;107(3):329-35.
13. Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97.
14. Takeyama M, Matsunaga A, Kakihana Y, Masuda M, Kuniyoshi T, Kanmura Y. Impact of Skin Incision on the Pleth Variability Index. J Clin Monit Comput 2011 Aug;25(4):215-21.

Signal IQ

The Signal IQ provides an indicator of the assessment of the confidence in the displayed SpO2 value. The SpO
SIQ can also be used to identify the occurrence of a patient’s pulse.
2
With motion, the plethysmographic waveform is often distorted and may be obscured by noise artifact. Shown as a vertical line, the SpO pulsation. Even with a plethysmographic waveform obscured by artifact, the Signal IQ
SIQ coincides with the peak of an arterial
2
identifies the timing that the algorithms have determined for the arterial pulsation. The pulse tone (when enabled) coincides with the vertical line of the SpO
SIQ.
2
The height of the vertical line of the SpO2 SIQ provides an assessment of the confidence in the measurement displayed. A high vertical bar indicates higher confidence in the measurement. A small vertical bar indicates lower confidence in the displayed measurement. When the Signal IQ is very low, this suggests that the accuracy of the displayed measurement may be compromised. See About the Status Bar on page 49.

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).
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Rad-97 Chapter 1: Technology Overview
2. The amount of arterial blood in tissue changes with pulse
(photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
The Rad-97 uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma.
The Rad-97 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a diode (detector). Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25 mW. The detector receives the light, converts it into an electronic signal and sends it to the Rad-97 for calculation.
1. Light Emitting Diodes (LEDs) (7 + wavelengths)
2. Detector
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Rad-97 Chapter 1: Technology Overview
Once Rad-97 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient’s functional oxygen saturation (SpO carboxyhemoglobin saturation (SpCO [%]), methemoglobin saturation (SpMet [%]), total
[%]), blood levels of
2
hemoglobin concentration (SpHb [g/dL]) and pulse rate (PR). 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. Maximum skin-sensor interface temperature was tested to be less than 41º C (106º F) in a minimum ambient temperature of 35º C (95º F). The tests were conducted with sensors operating at reasonable worst case power.

Pulse CO-Oximetry vs. Drawn Whole Blood Measurements

When SpO2, SpCO, SpMet, and SpHb measurements obtained from the Rad-97 (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 SpO SpMet, SpHb, and SpOC measurements of the Rad-97. 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 SpO the calculated measurement is not appropriately corrected for the effects of variables that
, different results are usually obtained from the arterial blood gas sample if
2
shift the relationship between the partial pressure of oxygen (pO2) and saturation, such as: pH,temperature, the partial pressure of carbon dioxide (pCO
), 2,3-DPG, and fetal hemoglobin.
2
In the case of SpCO, different results are also expected if the level of methemoglobin (MetHb) in the blood gas sample is abnormal (greater than 2% for MetHb).
In the case of SpHb, variation in hemoglobin measurements may be profound and may be affected by sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patient's clinical status should be repeated and/or supplemented with additional test data. As with most hemoglobin tests, a laboratory blood sample should be analyzed prior to clinical decision making.
High levels of bilirubin may cause erroneous SpO samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a
, SpMet, SpCO, and SpHb readings. As blood
2
meaningful comparison can only be achieved if the oxygen saturation (SaO2), levels of carboxyhemoglobin (COHb), and MetHb of the patient are stable and not changing over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory CO-Oximetry measurements of SpO administration of fluids and in procedures such as dialysis. Additionally, drawn whole blood
, SpCO, SpMet, SpHb, and SpOC may vary with the rapid
2
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.
, SpCO,
2

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.
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