Operators Manual
228 Pages
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Operator's Manual
Rad-97® Pulse CO-Oximeter®
For Sale in the USA These operating instructions provide the necessary information for proper operation of all models of the Rad-97. 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 Rad-97 are prerequisites for its proper use. Do not operate Rad-97 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. 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-MWM2 | Model: Rad-97 | IC: 7362A- MWM1 or 7362A-MWM2 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,CAN/CSA C22.2 No. 60601-1:2008, and applicable Particular (EN/ISO 80601-2-61:2011 and IEC 80601-2-30:2013) 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
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®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, Kite®, Masimo®, NomoLine®, Pulse CO-Oximeter®, PVi®, Rad-97®, rainbow SET®, rainbow®, rainbow Acoustic Monitoring®, rainbow Resposable®, RAM®, RRa®, RRp®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®, and SpMet®, and X-Cal® are federally registered trademarks of Masimo Corporation. Adaptive Threshold Alarm™, In Vivo Adjustment™, ORi™, and SpOC™ 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
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Contents About This Manual-------------------------------------------------------------------------------------------7 Product Description, Features and Indications for Use----------------------------------------------- 9 Product Description ------------------------------------------------------------------------------------- 9 Indications for Use------------------------------------------------------------------------------------- 10 Contraindications -------------------------------------------------------------------------------------- 12 Safety Information, Warnings and Cautions ---------------------------------------------------------- 13 Safety Warnings and Cautions ----------------------------------------------------------------------- 13 Performance Warnings and Cautions --------------------------------------------------------------- 15 Cleaning and Service Warnings and Cautions ---------------------------------------------------- 21 Compliance Warnings and Cautions ---------------------------------------------------------------- 22 Chapter 1: Technology Overview ------------------------------------------------------------------------ 25 Signal Extraction Technology® (SET®) ------------------------------------------------------------ 25 rainbow Pulse CO-Oximetry Technology -----------------------------------------------------------28 rainbow Acoustic Monitoring™ (RAM™) ----------------------------------------------------------- 33 Chapter 2: Description ------------------------------------------------------------------------------------ 37 General System Description -------------------------------------------------------------------------- 37 Features ------------------------------------------------------------------------------------------------- 38 Chapter 3: Setting Up------------------------------------------------------------------------------------- 43 Unpacking and Inspection --------------------------------------------------------------------------- 43 Preparation for Use ------------------------------------------------------------------------------------ 43 Guidelines for Setting Up ----------------------------------------------------------------------------- 43 Powering the Rad-97 ON and OFF ------------------------------------------------------------------- 44 Initial Battery Charging ------------------------------------------------------------------------------- 44 Nurse Call Connection -------------------------------------------------------------------------------- 45 Connecting to Wireless Network -------------------------------------------------------------------- 45 Attach NIBP Cuff --------------------------------------------------------------------------------------- 45 NomoLine Capnography Sampling Line Connection -------------------------------------------- 45 Masimo Kite --------------------------------------------------------------------------------------------- 46 Video Conferencing ------------------------------------------------------------------------------------ 46 Third-Party Devices ------------------------------------------------------------------------------------ 46 Chapter 4: Operation -------------------------------------------------------------------------------------- 47 www.masimo.com
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Rad-97
Contents
Using the Touchscreen and Home Button -------------------------------------------------------- 47 About the Main Screen ------------------------------------------------------------------------------- 51 About the System Status Light ---------------------------------------------------------------------- 59 Accessing Main Menu Options --------------------------------------------------------------------- 60 rainbow Parameter Settings ------------------------------------------------------------------------- 63 Parameter Settings ------------------------------------------------------------------------------------ 64 Temperature Settings --------------------------------------------------------------------------------- 81 Noninvasive Blood Pressure (NIBP) Settings ----------------------------------------------------- 83 NomoLine Capnography Settings ------------------------------------------------------------------- 87 Sounds --------------------------------------------------------------------------------------------------- 92 Device Settings ----------------------------------------------------------------------------------------- 93 About----------------------------------------------------------------------------------------------------107 Trends-------------------------------------------------------------------------------------------------- 108 Call ----------------------------------------------------------------------------------------------------- 110 Rad-97 Screenshot Capture ------------------------------------------------------------------------ 110 Patient Admit/Discharge ---------------------------------------------------------------------------- 112 EMR Push ----------------------------------------------------------------------------------------------- 112 Chapter 5: Profiles ---------------------------------------------------------------------------------------- 113 Profiles Overview -------------------------------------------------------------------------------------- 113 Changing Profiles ------------------------------------------------------------------------------------- 113 Profiles Settings --------------------------------------------------------------------------------------- 115 Replacing Factory Default Settings for Adult, Pediatric and Neonatal Profiles ------------ 115 Chapter 6: Temperature --------------------------------------------------------------------------------- 117 Temperature Window -------------------------------------------------------------------------------- 117 Chapter 7: Noninvasive Blood Pressure (NIBP) ----------------------------------------------------- 119 Operation - NIBP -------------------------------------------------------------------------------------- 119 NIBP Display ------------------------------------------------------------------------------------------- 119 Patient Category ------------------------------------------------------------------------------------- 120 Patient Conditions ----------------------------------------------------------------------------------- 120 Cuff Selection and Placement ---------------------------------------------------------------------- 121 Blood Pressure Measurement ----------------------------------------------------------------------- 122 Chapter 8: NomoLine Capnography ------------------------------------------------------------------- 127 Overview ------------------------------------------------------------------------------------------------ 127 www.masimo.com
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Rad-97
Contents
Operation ---------------------------------------------------------------------------------------------- 128 Chapter 9: Video Conferencing ------------------------------------------------------------------------ 135 Overview ----------------------------------------------------------------------------------------------- 135 Initiate a Call From Rad-97------------------------------------------------------------------------- 137 Receive a Call From Patient SafetyNet ----------------------------------------------------------- 137 Operations Available During Call------------------------------------------------------------------ 138 Alarms During Call ----------------------------------------------------------------------------------- 139 Chapter 10: Admit to and Discharge from Patient SafetyNet-------------------------------------141 Not Admitted ------------------------------------------------------------------------------------------ 141 Admitting a Patient ---------------------------------------------------------------------------------- 141 Discharging a Patient ------------------------------------------------------------------------------- 143 Chapter 11: Electronic Medical Records (EMR) Push ---------------------------------------------- 145 Determining EMR Push is Active ------------------------------------------------------------------ 145 Sending Patient Data to the EMR ----------------------------------------------------------------- 145 Chapter 12: Third-Party Devices------------------------------------------------------------------------ 147 Connect Device to Rad-97 --------------------------------------------------------------------------- 147 Chapter 13: Alarms and Messages -------------------------------------------------------------------- 149 Alarm Interface --------------------------------------------------------------------------------------- 149 About Alarms ----------------------------------------------------------------------------------------- 150 Adaptive Threshold Alarm (ATA) Feature -------------------------------------------------------- 153 3D Alarms --------------------------------------------------------------------------------------------- 154 Rad-97 Messages ------------------------------------------------------------------------------------- 156 Noninvasive Blood Pressure (NIBP) Messages ------------------------------------------------- 161 NomoLine Capnography Messages --------------------------------------------------------------- 162 Chapter 14: Troubleshooting -------------------------------------------------------------------------- 165 Troubleshooting Measurements ------------------------------------------------------------------- 165 Troubleshooting Rad-97 ---------------------------------------------------------------------------- 167 Chapter 15: Specifications ------------------------------------------------------------------------------ 171 Pulse CO-Oximetry Specifications ------------------------------------------------------------------ 171 SpO2 Performance Specifications ----------------------------------------------------------------- 173 RRp Performance Specifications ------------------------------------------------------------------ 176 Temperature Specifications ------------------------------------------------------------------------ 184 Noninvasive Blood Pressure (NIBP) Specifications -------------------------------------------- 185 www.masimo.com
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Rad-97
Contents
NomoLine Capnography Specifications ---------------------------------------------------------- 186 Electrical----------------------------------------------------------------------------------------------- 190 Environmental---------------------------------------------------------------------------------------- 190 Physical Characteristics ----------------------------------------------------------------------------- 191 Alarms -------------------------------------------------------------------------------------------------- 191 Display Indicators------------------------------------------------------------------------------------ 192 Compliance ------------------------------------------------------------------------------------------- 192 Connectors -------------------------------------------------------------------------------------------- 193 Wireless Specifications ----------------------------------------------------------------------------- 194 Guidance and Manufacturer's Declaration-Electromagnetic Emissions-------------------- 196 Guidance and Manufacturer's Declaration-Electromagnetic Immunity --------------------- 197 Recommended Separation Distances ------------------------------------------------------------ 199 Symbols------------------------------------------------------------------------------------------------ 200 Citations ----------------------------------------------------------------------------------------------- 203 Chapter 16: Service and Maintenance --------------------------------------------------------------- 205 Cleaning ----------------------------------------------------------------------------------------------- 205 Performance Verification --------------------------------------------------------------------------- 205 Nurse Call Setting Connections ------------------------------------------------------------------- 207 Calibration -------------------------------------------------------------------------------------------- 208 Maintenance ------------------------------------------------------------------------------------------- 211 Repair Policy ------------------------------------------------------------------------------------------- 212 Return Procedure ------------------------------------------------------------------------------------ 213 Contacting Masimo ---------------------------------------------------------------------------------- 213 Appendix: Concepts of Alarm Response Delay ------------------------------------------------------ 217 Concepts of Alarm Response Delay ---------------------------------------------------------------- 217 Index ------------------------------------------------------------------------------------------------------- 219
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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 (SpO2), pulse rate (PR), perfusion index (Pi), and Pleth 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.
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SpO2 and pulse rate monitoring in motion and low perfusion environments.
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Continuous and non-invasive monitoring of carboxyhemoglobin (SpCO), methemoglobin (SpMet), and total hemoglobin (SpHb).
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Respiration rate can be determined by the acoustic (RRa) or plethysmographic waveform (RRp).
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Oxygen Reserve Index (ORi)*, an index to measure changes in oxygen states under hyperoxic conditions.
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Wireless radio for transfer of parameter data.
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Sleep Study and optional Home operational modes.
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Optional integrated Noninvasive Blood Pressure (NIBP) technology.
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Optional integrated NomoLine capnography technology.
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Ability to display data on a secondary display.
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Optional camera and microphone for audio/video communication with Patient SafetyNet.
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Designed for third party measurement expansion to allow for additional platform measurements.
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.
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Rad-97
Product Description, Features and Indications for Use
Regulatory Notice The following features are NOT AVAILABLE. Feature
NOT AVAILABLE in U.S.A. and territories relying on FDA market clearance
SpO2 PR Pi PVi SpHb SpCO SpOC SpMet RRa RRp ORi
X
ATA
X
In-Vivo
X
NIBP NomoLine Capnography
Indications for Use The Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices. The Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, www.masimo.com 10 Masimo
Rad-97
Product Description, Features and Indications for Use
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 Rad-97 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 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. The Rad-97 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 Rad-97 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 Rad-97 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 optional Nomoline Capnography product family is intended to be connected to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to be connected to a patient breathing circuit for 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
Devices with Masimo technology are only to be used with Masimo sensors and cables. The Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
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Rad-97
Product Description, Features and Indications for Use
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.
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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
NomoLine Capnography WARNING: Carefully route the sampling line to reduce the risk of patient entanglement or strangulation. WARNING: Do not lift the Rad-97 by the NomoLine capnography sampling line as it could disconnect from the Rad-97, causing the device to fall on the patient. WARNING: Measurements can be effected by mobile and portable RF communications equipment. Make sure the Rad-97 is used in the electromagnetic environment specified in this manual. WARNING: Use of high-frequency electrosurgical equipment in the vicinity of Rad-97 may product interference and cause incorrect measurements. WARNING: Do not use the NomoLine Infant Airway Adapter Set with adult/pediatric patients. WARNING: Do only use sample lines intended for anesthetic agents if N2O and/or anesthetic agents are being used. WARNING: Exhaust gases should be returned to the patient circuit or to a scavenging system. WARNING: Due to the risk of patient cross-infection, always use a bacteria filter on the exhaust port side if sampled gas is intended to be re-breathed. WARNING: Do not re-use disposable single-patient use NomoLine Family sampling lines due to the risk of cross contamination.
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: Always ensure settings including alarm limits and alarm speaker volume are appropriate for each patient and facility's protocol and environment prior to use. Devices in which the alarm speaker is not working or the alarm speaker volume setting is not distinguishable from the facilities ambient noise should not be used. 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. Any results exhibiting inconsistency with the patient's clinical status should be repeated and/or supplemented with additional data. Blood samples should be analyzed by laboratory www.masimo.com
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Rad-97
Safety Information, Warnings and Cautions
instruments prior to clinical decision making to completely understand the patient’s condition. 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: Always check that speaker is functional prior to use. 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. 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, RRp, and ORi) can be affected by the following: •
Improper sensor application or use of incorrect sensor.
•
Blood pressure cuff applied to the same arm as the sensor site.
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Intravascular dyes such as indocyanine green or methylene blue.
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Venous congestion.
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Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position).
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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.
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Rad-97
Safety Information, Warnings and Cautions
•
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 SpO2 readings may be caused by: •
Elevated levels of COHb and/or MetHb.
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Severe anemia.
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Extremely low arterial perfusion.
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Excessive induced motion.
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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.
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Motion induced artifact.
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Low arterial oxygen saturation levels.
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Elevated COHb and/or MetHb levels.
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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias).
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Severe anemia.
WARNING: Inaccurate SpCO readings may be caused by: •
Elevated methemoglobin levels in the range of >15%.
•
Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias).
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Extremely elevated hemoglobin levels.
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Low arterial perfusion.
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Low arterial oxygen saturation levels including altitude induced hypoxemia.
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Motion induced artifact.
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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.
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Low arterial perfusion.
• Low arterial oxygen saturation levels including altitude induced hypoxemia. www.masimo.com 17 Masimo
Rad-97
Safety Information, Warnings and Cautions
•
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.
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Excessive ambient or environmental noise.
WARNING: Inaccurate RRp readings may be caused by: •
Low arterial perfusion.
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Motion induced artifact.
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Severe anemia.
WARNING: Inaccurate ORi readings may be caused by: •
Low arterial perfusion.
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Motion induced artifact.
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Elevated COHb and/or MetHb levels.
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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (Quantitative defects such as Thalassemias).
•
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 PaO2. 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. www.masimo.com
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Rad-97
Safety Information, Warnings and Cautions
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, 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 SpO2, SpHb, SpOC, SpCO, SpMet, RRp, and ORi readings. 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. www.masimo.com 19 Masimo
Rad-97
Safety Information, Warnings and Cautions
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 (SpO2) and respiration (RRa). 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. 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.
NomoLine Capnography WARNING: Use only airway T-adapters with the sampling point in the center of the adapter. WARNING: Do not use T-adapter with infants, as this adds 7 ml dead space to the patient circuit. WARNING: Do not use the NomoLine capnography with metered-dose inhalers or nebulized medications as this may clog the bacteria filter. WARNING: Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2), ensure that the Rad-97 is placed in a well ventilated place. Avoid breathing near the NomoLine capnography sidestream gas analyzer before or during the zeroing procedure. WARNING: The NomoLine capnography is intended only as an adjunct in patient assessment. It must be used in conjunction with other assessments of clinical signs and symptoms. WARNING: Replace the sampling line if the sampling line input connector starts flashing red, or Rad-97 displays a “Check sampling line” message. WARNING: Too strong positive or negative pressure in the patient circuit might affect the sample flow. www.masimo.com
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