Operator's Manual Rad-97™ Pulse CO-Oximeter®
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.
Rad-97™, rainbow SET™, 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 www.masimo.
Contents About This Manual-------------------------------------------------------------------------------------------7 Product Description, Features and Indications for Use----------------------------------------------- 9 Product Description ------------------------------------------------------------------------------------- 9 Indications for Use------------------------------------------------------------------------------------- 11 Contraindications --------------------------------------------------------
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 ---------------------------------------------------------------------- 61 rainbow Parameter Settings ----------------------------------------------------------
Rad-97 Contents Operation ---------------------------------------------------------------------------------------------- 132 Chapter 9: Video Conferencing ------------------------------------------------------------------------ 139 Overview ----------------------------------------------------------------------------------------------- 139 Initiate a Call From Rad-97-------------------------------------------------------------------------- 141 Receive a Call From Patient SafetyNet -------------------------
Rad-97 Contents Environmental----------------------------------------------------------------------------------------- 187 Physical Characteristics ---------------------------------------------------------------------------- 188 Alarms ------------------------------------------------------------------------------------------------- 188 Display Indicators------------------------------------------------------------------------------------ 189 Compliance ------------------------------------------------------
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.
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 Respirati
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 X ORi X ATA X In-Vivo X NIBP NomoLine Capnography www.masimo.
Rad-97 Product Description, Features and Indications for Use 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).
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.
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.
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.
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.
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. • Severe anemia. • Extremely low arterial perfusion. • Excessive induced motion.
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.
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.
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).
Rad-97 Safety Information, Warnings and Cautions Kite WARNING: Kite does not generate or manage alarms. The connected device's alarms, used in conjunction with clinical signs and symptoms, are the primary sources for determining that an alarm condition exists. CAUTION: Kite is not a primary display. Medical decisions should be made using data from the primary display of a device in conjunction with clinical signs and symptoms. CAUTION: Kite is intended to operate across the facility's network.
Rad-97 Safety Information, Warnings and Cautions 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.
Rad-97 Safety Information, Warnings and Cautions • 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.
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.
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. 2. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry). The amount of arterial blood in tissue changes with your pulse (photoplethysmography).
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.
Rad-97 Chapter 1: Technology Overview 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. 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. Haas S., Trepte C.
Rad-97 2. Chapter 1: Technology Overview (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry). 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.
Rad-97 Chapter 1: Technology Overview 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.
Rad-97 Chapter 1: Technology Overview fluctuations in the oxygen saturation, blood concentration and perfusion. See Safety Information, Warnings and Cautions on page 13 and Troubleshooting Measurements on page 169. General Description for Total Arterial Oxygen Content (CaO2) Oxygen (O2) is carried in the blood in two forms, either dissolved in plasma or combined with hemoglobin. The amount of oxygen in the arterial blood is termed the oxygen content (CaO2) and is measured in units of ml O2/dL blood.
Rad-97 Chapter 1: Technology Overview Successful Monitoring for SpCO A stable SpCO reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient's fingertip (measurement site). Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion.
Rad-97 Chapter 1: Technology Overview The measurement is taken by a sensor capable of measuring ORi, usually on the fingertip for adult or pediatric patients. The sensor connects directly to the Pulse CO-Oximeter or with a patient cable. The sensor collects signal data from the patient and sends it to the device. The device displays the processed data as an indicator of changes in oxygen states in hyperoxic conditions.
Rad-97 Chapter 1: Technology Overview Patient Sensor Acquisition System Respiratory airflow to sound Sound to electrical signal Electrical signal to digital signal Signal Processing Envelope Detection RRa Estimation Digital signal to respiratory measurement Patient The generation of respiratory sounds is primarily related to turbulent respiratory airflow in upper airways.
Rad-97 Chapter 1: Technology Overview The respiratory cycle envelope signal processing principle is similar to methods that sample airway gasses and subsequently determine a respiratory rate. Citations [1] A.R.A. Sovijärvi, F. Dalmasso, J. Vanderschool, L.P. Malmberg, G. Righini, S.A.T. Stoneman. Definition of terms for applications of respiratory sounds. Eur Respir Rev 2000; 10:77, 597-610. [2] Z. Moussavi. Fundamentals of respiratory sounds analysis. Synthesis lectures on biomedical engineering #8.
Chapter 2: Description This chapter contains the description of the Rad-97 physical features. General System Description The Rad-97 system includes the following: • Rad-97 Device • AC Power Cord • Patient Cable • Sensor For a complete list of compatible sensors and cables, visit http://www.masimo.com. www.masimo.
Rad-97 Chapter 2: Description Features Front View 1. Display and Touchscreen Provides a user interface to view and change settings. 2. Home Button Provides a multipurpose user interface that allows for navigation to the home screen as well as turning the device on and off. 3. Patient Cable Port Provides a connection to a patient cable or sensor. 4. Microphone* Provides sound for video conferencing. 5. Camera* Provides video for video conferencing. *Optional feature.
Rad-97 Chapter 2: Description 4. NIBP Nib* Allows connection to a cuff for blood pressure measurements. 5. NomoLine Capnography Input Connector* Allows connection to NomoLine™ for capnography measurements. LEGI Indicator provides visual indications of capnography status. See NomoLine Capnography LEGI Indicator on page 60. *Optional feature. Only available on Rad-97 equipped with NIBP or NomoLine Capnography capabilities. www.masimo.
Rad-97 Chapter 2: Description Back View 1. Nurse Call Connector Allows connection to a Nurse Call system. CAUTION: To ensure patient electrical isolation, all external device connections to the Analog Output/Nurse Call connectors must be IEC 60950-1, IEC 60601-1, or UL 1069 compliant. See Nurse Call Connection on page 45. 2. Ethernet Allows network connection to Rad-97 using an RJ-45 cable. 3. USB Provides USB 2.0 connectivity. 4.
Rad-97 Chapter 2: Description Side and Top Views 1. Speaker The speaker provides audio alarms. Care should be taken not to cover the speaker. 2. Swivel Foot Provides stability when placing Rad-97 on a surface in a vertical position. 3. Foot Pads Provides physical support to Rad-97 when placed on a surface in a horizontal position. 4. System Status Light Provides an indication of alarm status. See About the System Status Light on page 59. www.masimo.
Chapter 3: Setting Up This chapter contains information about setting up Rad-97 before use. Unpacking and Inspection To unpack and inspect the Rad-97: 1. 2. 3. Remove the Rad-97 from the shipping carton and examine it for signs of shipping damage. Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact the Masimo Technical Service Department.
Rad-97 Chapter 3: Setting Up Powering the Rad-97 ON and OFF To Power ON Rad-97 1. Press and hold the Home Button for more than two (2) seconds, until one (1) audible tone sounds. 2. The Home Button will illuminate Green and the Rad-97 will power on. To Power OFF Rad-97 When powering off the Rad-97, the device remembers the last settings if the Power on Profile is set to Previous Profile. See Access Control on page 107.
Rad-97 Chapter 3: Setting Up • 4. When Rad-97 is ON and charging, the AC Power Indicator lightning bolt icon will appear on the screen. • When Rad-97 is OFF and charging, the Home button will illuminate Orange. When the battery is fully charged: • When Rad-97 is ON and fully charged, the AC Power Indicator will change to a plug icon. Touch the AC Power Indicator icon to view battery charge details. See Rad-97 Battery on page 106.
Rad-97 Chapter 3: Setting Up Masimo Kite Masimo Kite Software Application is a passive monitoring interface to Point-of-Care (POC) Masimo medical devices (Rad-97 for example) that co-exist under the same Wi-Fi network. Kite remotely displays system and parameter status reported by the POC device on a separate monitor. Rad-97 must be on the same network as Kite.
Chapter 4: Operation The information in this chapter assumes that Rad-97 is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Rad-97 without completely reading and understanding these instructions. Using the Touchscreen and Home Button 1. Main Screen To access settings and other screens, touch a value or icon on the Display View. See About the Main Screen on page 51. 2.
Rad-97 Chapter 4: Operation Using the Touchscreen Interface Using the gestures described below, the user is able to customize the viewing experience, including displaying the highest priority parameters and measurements. Feature navigation availability is dependent on which medical devices are connected to Rad-97. Action Illustration Example Description Touch Touch and release. Action performed once finger is released. Touch and Hold Touch and hold. Action performed once hold duration is reached.
Rad-97 Control Chapter 4: Operation Applicable Actions Description Touch and slide left or right of toggle • Quickly moves knob left or right • Switches between toggle states Touch and slide left or right of toggle • Quickly moves knob left or right Touch label • Quickly moves knob left or right Labeled Toggle Touch and slide knob Spinner Slider Slider Spinner Touch center (focused) • tile • When closed, expands spinner When open, collapses spinner Swipe up or down • When open, scrol
Rad-97 Control Window Well Chapter 4: Operation Applicable Actions Description Swipe left or right (anywhere) • Scrolls icons left or right Touch bottom indicator icon • Quickly centers tile corresponding to indicator icon Touch parameter or measurement • When no parameter or measurement alarm is present, opens parameter or measurement menu • When parameter or measurement alarm is present, silences parameter or measurement alarm Touch and hold • Enables parameter and measurement drag and
Rad-97 Chapter 4: Operation Control Applicable Actions Description Alarm Silence icon Touch • Silences all alarms Audio Pause icon Touch • Enables Audio Pause Other Status Bar icons Touch • Opens relevant menu Back Arrow Touch • Exits menu, abandons any changes About the Main Screen The Main Screen consists of different areas. Ref. Feature Information 1 Status Bar See About the Status Bar on page 52. 2 Action Menu See About the Action Menu on page 55.
Rad-97 Chapter 4: Operation Ref. Feature Information 7 Main Menu See Accessing Main Menu Options on page 61. 8 Patient Admit/Discharge See Patient Admit/Discharge on page 115. 9 Call* See Call on page 113. * The Call icon does not appear until the camera is enabled. See Camera on page 101. This feature is optional on Rad-97 devices. About the Status Bar The Status Bar is visible on the top portion of the Main Screen. Ref.
Rad-97 Chapter 4: Operation Ref. Feature Description 5 Displays current status of camera operation. When selected, provides access to the Camera window to enable and disable the camera. Camera* See Camera on page 101. 6 Bluetooth Provides access to the Bluetooth screen. If this icon is visible, then Bluetooth connectivity has been enabled. See Bluetooth on page 105. 7 Wi-Fi Provides access to the Wi-Fi screen. If this icon is visible, then Wi-Fi connectivity has been enabled.
Rad-97 Chapter 4: Operation AC Power Indicator Whenever Rad-97 is connected to an AC power source and ON, the AC Power Indicator icon will appear on the display as follows: Icon Status Battery is currently charging Battery is fully charged Touch the AC Power Indicator icon to view battery charge details. See Rad-97 Battery on page 106.
Rad-97 Chapter 4: Operation About the Action Menu To expand the Action Menu, select the arrow in the upper right corner of the window. Note: After approximately 10 seconds without interaction, the Action Menu will retract. The Action Menu allows quick access to the following settings directly from the Main Screen: • Sensitivity - Selecting this option cycles through the available sensitivity modes: APOD, NORM and MAX. See Sensitivity Modes Overview on page 56.
Rad-97 Chapter 4: Operation Sensitivity Modes Overview Three sensitivity levels enable a clinician to tailor the response of Rad-97 to the needs of the particular patient situation. Sensitivity Modes are accessed through the Action Menu. See About the Action Menu on page 55. The sensitivity levels are as follows: • NORM (Normal Sensitivity) NORM is the recommended sensitivity mode for patients who are experiencing some compromise in blood flow or perfusion.
Rad-97 Chapter 4: Operation To expand a parameter or measurement Order Instruction Step 1 Touch and hold the Numeric Value until it dims. Step 2 Drag the Numeric Value over any Trend Display. Step 3 Release the Numeric Value. To minimize a parameter or measurement Order Instruction Step 1 Touch and hold the Numeric Value until it shrinks. Step 2 Drag the Numeric Value to the Well. Step 3 Release the Numeric Value. www.masimo.
Rad-97 Chapter 4: Operation Customizing Trend View There are different ways to view trend information. The following is an example of trend information for SpO2, PR, and Pi as they appear within the Main Screen with the device in the horizontal position: In Trend View, a parameter or measurement is displayed as a graph of its values over time. The following diagram and table describe key features of a parameter's trend display in Trend View. Ref.
Rad-97 Chapter 4: Operation Data can be added to or removed from Trend View in the same manner as described in Customizing Windows on page 56. Data can be manipulated using the touchscreen as follows: 1. 2. 3. 4. Swipe the trend view display left or right to scroll the Trend View data forward or backward in time. Tap the Trend View in a specific spot to view the values at that time. Touch the box in the lower right corner of the screen to change the time range of Trend View data displayed on the screen.
Rad-97 Chapter 4: Operation NomoLine Capnography LEGI Indicator The Light Emitting Gas Inlet (LEGI) Indicator provides visual indications of NomoLine capnography status. The indicator will illuminate in different colors depending on the state of the device. The LEGI Indicator is located around the Capnography connector on the front of the device.
Rad-97 Chapter 4: Operation Accessing Main Menu Options To access Main Menu options, press the Main Menu icon in the bottom left corner of the touchscreen: The Main Menu options are: rainbow Parameter Settings Displayed on devices without NIBP or NomoLine Capnography. See Parameter Settings on page 64. rainbow Parameter Settings Displayed on devices with NIBP or NomoLine Capnography. See rainbow Parameter Settings on page 64. Temperature Settings Displayed on devices with a TIR-1 Thermometer connected.
Rad-97 Chapter 4: Operation Sounds See Sounds on page 95. Device Settings See Device Settings on page 96. About See About on page 110. 3D Alarms* Displayed on devices without NIBP or NomoLine Capnography. On devices with NIBP or NomoLine Capnography, this icon is displayed under the rainbow Parameter Settings menu. See 3D Alarms on page 158. Trends* See Trends on page 110. Rad-97 This icon is displayed when the Rad-97 is in optional Home mode (when available), allowing device settings to be changed.
Rad-97 Chapter 4: Operation Navigating the Main Menu Once the Main Menu screen is displayed, users can access additional screens, information and settings. Swipe the screen left or right to pan through the menu icons. Touch the arrow icon to return to the Main Screen. Note: Non-NIBP device used in the examples below. Icons at the bottom edge of the displayed menu screen correspond to the settings. Touch an icon to jump to the setting on the displayed menu screen.
Rad-97 Chapter 4: Operation rainbow Parameter Settings On Rad-97, the rainbow menu allows the user to view and customize settings for rainbow parameters: Parameter Settings See Parameter Settings on page 64. 3D Alarms See 3D Alarms on page 158. Additional Settings See Additional Settings on page 81. Parameter Settings The following is an example of the Rad-97 Parameter Settings screen. To access any of the available parameter setting screens: 1. 2.
Rad-97 • Chapter 4: Operation See SpO2 Settings on page 66 • See PR Settings on page 68 • See Pi Settings on page 69 • See PVi Settings on page 70 • See Respiration Rate (RR) Settings on page 71 • See SpHb Settings on page 75 • See SpOC Settings on page 78 • See SpMet Settings on page 78 • See SpCO Settings on page 79 • See ORi Settings on page 80 In Vivo Adjustment Overview In Vivo is currently not available in the U.S.A. and territories relying on FDA market clearance.
Rad-97 Chapter 4: Operation In the example below, the displayed SpO2 value of 96 takes into account an offset of -1.0, and the displayed SpHb value of 16.0 takes into account an offset of +0.4. The In Vivo Adjustment feature can be set to On or Off. The factory default setting is Off. If set to On, the parameter value is adjusted and an offset value appears. The offset value is set by the user.
Rad-97 Chapter 4: Operation Options Description Alarm Priority Factory Default Settings User Configurable Settings Low Limit Low Limit is the lower threshold that triggers an alarm. High 88% 1% to 98% in steps of 1% Sets the Rapid Desat limit threshold to the selected amount below the Low Alarm Limit. When SpO2 value falls below the Rapid Desat an Rapid Desat limit the audio and NA visual alarms are immediately triggered without respect to alarm delay.
Rad-97 Chapter 4: Operation *** For the 2 and 4 second settings the averaging time may range from 2-4 and 4-6 seconds, respectively. FastSat Overview FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend.
Rad-97 Chapter 4: Operation PR Alarms From the PR Alarms screen, change any of the following options: Options Description Alarm Factory Default User Configurable Priority Settings Settings High Limit High Limit is the upper threshold High that triggers an alarm. 140 bpm 35 bpm to 235 bpm, in steps of 5 bpm Low Limit Low Limit is the lower threshold that triggers an alarm.
Rad-97 Options Chapter 4: Operation Description Low Limit Low Limit is the lower threshold that triggers an alarm. Alarm Priority Factory Default Settings User Configurable Settings Medium 0.3 Off, or 0.03 to 0.09 in steps of 0.01 0.10 to 0.90 in steps of 0.10 1 to 18 in steps of 1 Silence Duration Sets the amount of time NA that the alarm is silenced.
Rad-97 Chapter 4: Operation PVi Alarms From the Alarms screen, change any of the following options: Options Description Alarm Priority Factory Default User Configurable Settings Settings High Limit High Limit is the upper Medium threshold that triggers an alarm. 40 Low Limit Low Limit is the lower threshold that triggers an alarm. 5 Silence Sets the amount of Duration time that the alarm is silenced. Medium 2 to 99, in steps of 1, or Off When set to Off, alarms are disabled.
Rad-97 Chapter 4: Operation Additional Settings for RRa on page 73 Additional Settings for RRp on page 75 Trends on page 110 About Parameter Information on page 83 RRa Settings RRa is active when the following conditions are all met: • RRa is installed on the Rad-97. • A dual rainbow cable is connected. • An acoustic sensor is connected. Note: See the Directions for Use provided with the acoustic sensor.
Rad-97 Chapter 4: Operation Options Description Alarm Priority Factory Default Settings User Configurable Settings Low Limit Low Limit is the lower threshold that triggers an alarm. High 6 breaths per minute Off, or 5 to 118 breaths per minute in steps of 1 breaths per minute Silence Duration Sets the amount of time that the alarm is silenced. NA 2 minutes 30 seconds or 1, 2 or 5 minutes Respiratory Pause The duration of time that triggers an alarm if no breaths are detected.
Rad-97 Chapter 4: Operation When using a pulse oximetry or pulse CO-Oximetry sensor with Rad-97, respiration rate can be determined by the plethysmographic waveform (RRp). This method measures a patient's respiratory rate based on plethysmographic amplitude changes corresponding to the respiratory cycle. When using a pulse oximetry or pulse CO-Oximetry sensor, RRp alarms and RRp settings are active and the Main Screen labels respiratory rate as RRp, as shown below.
Rad-97 Chapter 4: Operation Additional Settings for RRp From the Additional Settings screen, change any of the following options: Options Description Factory Default Settings User Configurable Settings Averaging Time The length of time over which the system calculates the average of all data points. Slow No Averaging, Fast, Medium, Slow, Trending Freshness The duration of time that, during interference, the system displays the last valid reading.
Rad-97 Chapter 4: Operation SpHb Alarms From the Alarms screen, change any of the following options: Options Description High Limit High Limit is the upper threshold that triggers an alarm. Alarm Priority Factory Default Settings User Configurable Settings High 17.0 g/dL 2.0 g/dL to 24.5 g/dL in steps of 0.1 g/dL, or Off (11.0 mmol/L) (170 g/L) (2.0 mmol/L to 15.0 mmol/L in steps of 0.1 mmol/L, or Off) (20 g/L to 245 g/L in steps of 1 g/L, or Off) When SpHb Precision is set to 1.
Rad-97 Chapter 4: Operation Additional Settings for SpHb From the Additional Settings screen, change any of the following options: Options Description Factory Default Settings Averaging Time The length of time over which the system Medium calculates the average of all data points. Short, Medium, or Long Arterial/Venous Mode Provides an arterial or venous value that displays on the main screen.
Rad-97 Chapter 4: Operation SpOC Settings From the SpOC Settings screen, access the following screens: SpOC Alarms on page 78 Trends on page 110 About Parameter Information on page 83 SpOC Alarms From the Alarms screen, change any of the following options: Options Description Alarm Priority Factory Default Settings User Configurable Settings High Limit High Limit is the upper Medium threshold that triggers an alarm.
Rad-97 Chapter 4: Operation SpMet Alarms From the Alarms screen, change any of the following options: Options Description High Limit High Alarm Limit is the upper threshold that triggers an alarm. Low Limit Silence Duration Alarm Priority Factory Default User Configurable Settings Settings High 3.0 1.0% to 2.0% in steps of 0.1% 2.5% to 99.5% in steps of 0.5%, or Off Low Alarm Limit is the lower Medium Off threshold that triggers an alarm. Off, or 0.1% to 2.0% in steps of 0.
Rad-97 Chapter 4: Operation SpCO Alarms From the Alarms screen, change any of the following options: Options Description Alarm Priority Factory Default Settings User Configurable Settings High Limit High Limit is the upper threshold that triggers an alarm. High 10 2% to 98%, in steps of 1%, or Off Low Limit is the lower threshold that triggers an alarm. Medium Sets the amount of time that the alarm is silenced.
Rad-97 Chapter 4: Operation Trends on page 110 About Parameter Information on page 83. ORi Alarms From the Alarms screen, change any of the following options: Options Description Alarm Priority Factory Default Settings User Configurable Settings High Limit High Limit is the upper threshold that triggers an alarm. Medium Off 0.02 to 0.99 or Off in increments of 0.01 Low Limit Low Limit is the lower threshold that triggers an alarm. Medium Off Off, or 0.01 to 0.98 in increments of 0.
Rad-97 Chapter 4: Operation Option Description Factory Default User Configurable Settings Settings Waveform Mode Change the Waveform View. Pleth + Sig IQ + Acoustic See Waveform Mode on page 82. SmartTone Enable or disable the SmartTone. Acoustic, Pleth + Sig IQ, Pleth + Sig IQ + Acoustic, PVi Pleth + Sig IQ, or PVi Pleth + Sig IQ + Acoustic Off On, Off Off Off, 1% to 98% See Sounds on page 95. SpO2 low % limit Set the SpO2 low limit alarm. See SpO2 Settings on page 66.
Rad-97 Chapter 4: Operation Pleth + Sig IQ + Acoustic View The waveform is located above the parameter values. This view contains the Pleth waveform, signal quality indicators, and acoustic waveform (if RRa is available). About Parameter Information Additional information about each parameter is available. To access additional information about parameters: 1. From the Parameter Settings screen, touch the About icon. The following is an example for SpO2. 2.
Rad-97 Chapter 4: Operation Options Description Alarm Priority Factory Default Settings User Configurable Settings High Limit High Limit is the upper threshold that triggers an alarm. Medium Off 80.2 °F to 109.9 °F, in increments of 0.1, or Off 26.9 °C to 43.2 °C, in increments of 0.1, or Off When set to Off, alarms are disabled. Low Limit Low Limit is the lower threshold that triggers an alarm. Medium Off 80.1 °F to 109.8 °F in increments of 0.1, or Off 26.8 °C to 43.
Rad-97 Chapter 4: Operation Parameter Settings See Parameter Settings for Noninvasive Blood Pressure (NIBP) on page 85. Intervals See Intervals Settings for NIBP on page 88. Additional Settings See Additional Settings for NIBP on page 89. Calibration See Calibration for NIBP on page 89.
Rad-97 Chapter 4: Operation SYS/DIA Alarms From the Systolic/Diastolic Settings screen, touch Alarms, and then change any of the following options: Options Description Systolic High Limit High Limit is the upper threshold that triggers an alarm. Limit is the lower Systolic Low Low threshold that triggers an Limit alarm. Diastolic High Limit The High Limit is upper threshold that triggers an alarm. Diastolic Low Limit Low Limit is the lower threshold that triggers an alarm.
Rad-97 Chapter 4: Operation MAP Settings From the Mean Arterial Pressure Settings screen, access the following screens: MAP Alarms on page 87 About Parameter Information on page 83 MAP Alarms From the Mean Arterial Pressure screen, touch Alarms, and then change any of the following options: Options Description High Limit High Limit is the upper threshold that triggers an alarm. Low Limit Low Limit is the lower threshold that triggers an alarm.
Rad-97 Chapter 4: Operation Pulse Rate Alarms From the Pulse Rate Settings screen, touch Alarms, and then change any of the following options: Options Description High Limit High Limit is the upper threshold that triggers an alarm. Low Limit Low Limit is the lower threshold that triggers an alarm.
Rad-97 Chapter 4: Operation Options Description Factory Default Settings User Configurable Settings Start Auto/Start Stat Starts NIBP measurement NA NA Additional Settings for NIBP Use the Additional Settings screen to configure the following option: Options Description Factory Default Settings User Configurable Settings Measurement Timeout Set the measurement timeout value.
Rad-97 Chapter 4: Operation NomoLine Capnography Settings Note: This feature is optional on Rad-97 devices. The Capnography menu allows the user to view and customize settings for NomoLine Capnography by changing any of the following options: Parameter Settings See Parameter Settings for NomoLine Capnography on page 90. Additional Settings See Additional Settings on page 94.
Rad-97 Chapter 4: Operation EtCO2 Alarms From the End-Tidal Carbon Dioxide screen, touch Alarms, and then change any of the following options: Options Description Alarm Priority Factory Default Settings User Configurable Settings 0.2 to 24.9 vol% in steps of 0.1, or Off High Limit is the upper High Limit threshold that triggers an alarm. 7.9 vol% Medium 7.9 kPa 60 mmHg 0.2 to 29.9 kPa in steps of 0.1, or Off 2 to 224 mmHg in steps of 1, or Off When set to Off, alarm is disabled Off, or 0.1 to 24.
Rad-97 Chapter 4: Operation FiCO2 Alarms From the Inspired Carbon Dioxide screen, touch Alarms, and then change any of the following options: Options Description Alarm Priority Factory Default Settings User Configurable Settings 0.2 to 24.9 vol% in steps of 0.1, or Off High Limit is the upper High Limit threshold that triggers an alarm. 0.8 vol% Medium 0.8 kPa 6 mmHg 0.2 to 29.9 kPa in steps of 0.1, or Off 2-224 mmHg in steps of 1, or Off When set to Off, alarm is disabled Off, or 0.1 to 24.
Rad-97 Chapter 4: Operation RR Alarms From the Respiratory Rate screen, touch Alarms, and then change any of the following options: Options Alarm Priority Description High Limit is the upper High Limit threshold that triggers an alarm. High Factory Default Settings 50 User Configurable Settings 2 to 149 in steps of 1, or Off When set to Off, alarm is disabled Off, or 1 to 148 in steps of 1 Low Limit Low Limit is the lower threshold High that triggers an alarm.
Rad-97 Chapter 4: Operation Options Description Factory Default Settings User Configurable Settings RR 35 1 to 150 in steps of 1 0.0 vol% 0.0 to 24.9 vol% in steps of 0.1 0.0 kPa 0.0 to 29.9 kPa in steps of 0.1 0 mmHg 0 to 224 mmHg in steps of 1 0 0 to 149 in steps of 1 Y-Axis Min EtCO2, FiCO2 The Trend Min, indicating the lowest value that will be shown.
Rad-97 Chapter 4: Operation Sounds Use the Sounds screen to control the volume of sounds and duration of audio pause on Rad-97. Users can also access the Sounds screen by pressing the Sounds icon on the Status Bar. See About the Status Bar on page 52. Option Description Factory Default Settings User Configurable Settings Alarm Volume Sets the alarm volume level. 4 (Highest volume) 1 to 4 - Slide towards the left to decrease volume and to silence.
Rad-97 Chapter 4: Operation Device Settings The Device Settings menu allows the user to view and customize settings for Rad-97. Note: When in Home mode, items below marked with an * are displayed in the Main Menu; no other device settings are available. See Home on page 99. The Device Settings options are: Localization See Localization on page 97. Device Mode See Device Mode on page 98. Screen Orientation* See Screen Orientation on page 100. Ethernet See Ethernet on page 102.
Rad-97 Chapter 4: Operation Access Control See Access Control on page 107. Device Output See Device Output on page 109. Localization Use the Localization screen to view the current date and time and configure settings related to local time, language and geography. The user can also access the Localization screen by pressing the current time on the Status Bar. See About the Status Bar on page 52.
Rad-97 Chapter 4: Operation Device Mode The Device Mode screen allows the user to select the device operating mode. Continuous Monitoring is the default device mode. When the Rad-97 is turned off, the device mode is stored. Rad-97 will start in the same mode when turned on again. Access to the Device Mode screen is password protected. 1. 2. 3. 4. When the screen displays, press the key. Enter the following: 6 2 7 4 To undo an entry, press the Backspace key.
Rad-97 Chapter 4: Operation Home In Home mode, Rad-97 operates using the Continuous Monitoring settings in effect at the time Home mode is enabled (Profiles, Alarms, Trends, etc.). Rad-97 operation changes as follows when in Home mode: • Alarm tone volume is set to the highest level and cannot be changed. • Pulse tone volume can be changed; however, all other sound settings are disabled. • The Alarm Silence button is not included on the Main Screen. See About Alarms on page 154.
Rad-97 Chapter 4: Operation • Visual alarms display. If the display is off when an alarm triggers, the display wakes and displays the visual alarm until the alarm event is resolved. • Sounds are disabled and cannot be changed. • Profile settings are not available (device operates in the profile set during Continuous Monitoring mode). • Home button illumination turns off. • SpO2 averaging time defaults to 2-4 seconds and cannot be changed. See Additional Settings for SpO2 on page 67.
Rad-97 Chapter 4: Operation Camera Note: This feature is optional on Rad-97 devices. Use the Camera screen to enable or disable camera connectivity. The camera icon appears in the Status Bar regardless of camera settings. The user can also access the Camera screen by touching the camera icon on the Status Bar. See About the Status Bar on page 52. Option Description Factory Default User Configurable Setting Settings Video Conferencing Enabled Enables or disables video conference capabilities.
Rad-97 Chapter 4: Operation Ethernet Use the Ethernet screen to enable or disable Ethernet connectivity. When Ethernet connectivity is enabled, the Ethernet icon will appear in the Status Bar. The user can also access the Ethernet screen by pressing the Ethernet icon on the Status Bar. See About the Status Bar on page 52. Option Description Factory Default Settings User Configurable Settings Ethernet Enables or disables Ethernet connectivity.
Rad-97 Chapter 4: Operation Option Description Factory Default User Configurable Settings Settings Status Displays connected wireless network status. NA Change Network* Allows device to be connected to a NA different wireless network. See Status on page 103. See Change Network on page 104. * If the wireless network is changed for a device that is connected to Patient SafetyNet, that device will no longer be connected to Patient SafetyNet when connected to a different wireless network.
Rad-97 Chapter 4: Operation Option* Description Factory Default Setting User Configurable Settings Network Name SSID for the wireless network. NA Alphanumeric Security Allows the wireless network security to be set. None None, WPA, or WPA2 Password Password for the wireless network. NA Alphanumeric Save NA Press/select to save. Saves any changes to the fields. * Not all options listed may be displayed on the device.
Rad-97 Chapter 4: Operation * Displays when WPA Enterprise or WPA2 Enterprise is selected for security. ** Displays when any of the security options are selected. Network Scan To scan for and connect to an available wireless network, perform the following: 1. 2. 3. 4. Press/select the search icon next to Manual Setup to display the Select a Network screen. A network search is automatically performed and displays a list of available wireless networks.
Rad-97 Option Pair Chapter 4: Operation Description Factory Default Settings Allows specific devices to be paired to Rad-97. User Configurable Settings Select to Pair a device. NA See Chapter 12: Third-Party Devices on page 151. Additional fields in the Bluetooth screen display read-only settings about the Bluetooth connection that cannot be configured by the user. Your Masimo sales representative can provide necessary information regarding an initial Bluetooth connection.
Rad-97 Chapter 4: Operation Brightness Use the Brightness screen to adjust the brightness of Rad-97's display. Option Description Factory Default Settings Auto Brightness Allows automatic adjustment of display brightness based on the ambient light Off level. On or Off Brightness Adjust the brightness level of the display manually.
Rad-97 Chapter 4: Operation Option Description Factory Default Settings User Configurable Settings Power on Profile Sets the profile used when the device is powered on. See Chapter 5: Profiles on page 117. Previous Profile Previous Profile, Adult, Pediatric, Neonatal, or User defined profile (up to 8) All Mute Enabled Enables parameter Alarm Silence menu option. See Sounds on Off page 95. On or Off Lock Alarm Volume Sets the lowest alarm volume level.
Rad-97 Chapter 4: Operation Device Output The Device Output screen allows the user to configure additional data output options. A Nurse Call can be triggered based on alarm, low Signal IQ events, or both. In addition, Nurse Call Polarity can be inverted to accommodate local Nurse Call station requirements. The Device Output screen can also be accessed by selecting the Device Output icon on the Status Bar. See About the Status Bar on page 52.
Rad-97 Chapter 4: Operation About For information about individual parameters, see About Parameter Information on page 83. Use the About screen to view the serial number as well as Rad-97 software and hardware version information. These details may be helpful during troubleshooting. Option * Description Serial Number Displays the serial number for the device. MCU Displays the version number of the device board software. Processor Displays the version number of the system level software.
Rad-97 Chapter 4: Operation Option Description Factory Default Settings User Configurable Settings Clear Trends Deletes all stored trend data. N/A Press Clear to delete all stored trend data. Y-axis Min 50 0 to 95 in steps of 5 Y-axis Max 100 5 to 100 in steps of 5 Y-axis Min 25 25 to 235 in steps of 5 Y-axis Max 200 30 to 240 in steps of 5 Y-axis Min 5.0 g/dL 0.0 to 24.9 g/dL in increments of 0.1 Y-axis Max 20.0 g/dL 0.1 to 25.0 g/dL in increments of 0.1 Y-axis Min 3.
Rad-97 Option Chapter 4: Operation Description Factory Default Settings User Configurable Settings Y-axis Max 15.0 1.0 to 100.0 in increments of 0.5 Y-axis Min 0.0 0.0 to 19.0 in increments of 1.0 Y-axis Max 20.0 1.0 to 20.0 in increments of 1.0 Y-axis Min 0 0 to 99 in steps of 1 Y-axis Max 30 1 to 100 in steps of 1 Y-axis Min 0 0 to 34 in steps of 1 Y-axis Max 20 1 to 35 in steps of 1 Y-axis Min 0.00 0.00 to 0.99 in increments of 1.0 Y-axis Max 1.00 0.01 to 1.
Rad-97 Chapter 4: Operation Call The Call icons on the Main Screen allow video conferencing to be established between the Patient SafetyNet View Station and Rad-97. The Call icon does not appear on the Main Screen until the camera is enabled. See Camera on page 101. A white Call icon initiates a call to Patient SafetyNet. See Initiate a Call From Rad-97 on page 141.
Rad-97 Chapter 4: Operation Capturing Screenshots To take a screenshot, swipe across the Rad-97 screen from right to left using 2 or more fingers simultaneously. • A confirmation flash will appear on the entire screen and a status message will be displayed briefly at the top of the Rad-97 screen. • The status message indicates the filename of the screenshot taken. Note: Any clinician or patient related names, IDs or identifiers are not captured and are replaced with "*****".
Rad-97 Chapter 4: Operation Patient Admit/Discharge When configured, this function allows the user to admit and discharge a patient through Patient SafetyNet. Depending on patient status, different icons display on the Main Screen. Icon Name Description Admit Select to admit a patient. Discharge Indicates a patient is currently admitted. Select to discharge admitted patient.
Chapter 5: Profiles The following chapter contains information about profiles and profile settings. Profiles Overview Note: When in Sleep Study mode or optional Home mode (when available), Profiles settings are not available. The device operates in the profile set during Continuous Monitoring mode. See Sleep Study on page 99 and Home on page 99. Rad-97 contains a Profiles screen which lets the user customize settings for different patient populations: • Adult Adult profile is the factory default profile.
Rad-97 • Chapter 5: Profiles Select Profiles from the Main Menu as shown below. Once the Profiles screen displays you can switch to a different profile or choose a different patient category (Adult, Pediatric, Neonate) for the selected profile. To switch to a different profile: From the Profiles screen, touch the Profile Name field. 1. Select the desired profile by scrolling up or down. 2. When finished, touch OK. To confirm selection, check the Status Bar.
Rad-97 Chapter 5: Profiles • Neonatal = Purple • If the profile is displayed with an asterisk*, Home button illumination is turned Off. To choose a different category for the selected patient profile: From the Profiles screen, touch the Configure Profile Edit button. 1. 2. 3. Select the desired patient category by scrolling up or down. When finished, touch OK. To confirm selection, check the Status Bar.
Rad-97 Chapter 5: Profiles The user can also load preferred profile settings into the Rad-97 using a separate tool. To change the factory default settings for Adult, Pediatric or Neonatal profile settings 1. 2. 3. Change Rad-97 settings to the desired configuration. Navigate to the Access Control screen. See Access Control on page 107. Touch Save to save the change to the default profile. 4. 5. Touch Ok to confirm the change.
Chapter 6: Temperature Rad-97 can connect with the TIR-1 Thermometer though the Bluetooth connection. See Third-Party Devices. For performing temperature measurements using the TIR-1 Thermometer, refer to the Operator's Manual, TIR-1 Thermometer. Temperature Window The Temperature Window displays on the Main Screen ONLY when a TIR-1 Thermometer is paired to Rad-97. The temperature measurement taken using the TIR-1 Thermometer displays in the Temperature Window.
Chapter 7: Noninvasive Blood Pressure (NIBP) Operation - NIBP Note: This feature is optional on Rad-97 devices. Rad-97 works by noninvasively monitoring the amplitude of cuff pressure changes during cuff deflation to determine arterial blood pressure. The cuff pressure is first elevated above the patient's systolic blood pressure level. The cuff will then begin to deflate at a certain rate.
Rad-97 Chapter 7: Noninvasive Blood Pressure (NIBP) Ref.* Feature Information 7 Parameter Window See Parameter Settings on page 64. 8 Main Menu See Accessing Main Menu Options on page 61. * For information about the icons not mentioned in this table, see About the Main Screen on page 51. ** Optional feature on Rad-97. Patient Category The below table provides a method for selecting the appropriate Noninvasive Blood Pressure (NIBP) patient category.
Rad-97 Chapter 7: Noninvasive Blood Pressure (NIBP) Note: It is recommended that the clinician ask the patient to relax and not speak during measurement. Note: It is recommended that 5 minutes elapse before the first reading is taken. Cuff Selection and Placement Rad-97 uses a bayonet hose with a blood pressure cuff to measure NIBP. For a list of compatible NIBP patient hoses and cuffs, visit http://www.masimo.com/. To ensure the correct cuff size Wrap the cuff around the arm.
Rad-97 Chapter 7: Noninvasive Blood Pressure (NIBP) Blood Pressure Measurement Spot Check NIBP Measurement 1. Ensure that the correct patient profile is selected before measurement. WARNING: Only use Rad-97 in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. Note: The Patient Category determines the initial inflation pressure of NIBP. Ensure that the proper patient profile and associated patient category are appropriate for the intended patient. 2.
Rad-97 6. Chapter 7: Noninvasive Blood Pressure (NIBP) Wait for measurement values to appear to ensure that the NIBP measurement is complete. Automatic Interval Measurement Automatic Interval Measurement mode will take blood pressure measurements once every desired interval. To measure blood pressure in Automatic Interval Measurement Mode 1. Ensure that the correct patient profile is selected before measurement.
Rad-97 Chapter 7: Noninvasive Blood Pressure (NIBP) 6. The device will begin the Automatic Interval Measurement and display the specified interval designated by the clinician (15 minutes in the example below). Wait for measurement to complete or touch the Stop button to stop the measurement. 7. Note: Once finished measuring, values will appear and the next measurement will begin after the specified interval.
Rad-97 4. 5. 6. Chapter 7: Noninvasive Blood Pressure (NIBP) To enable Stat mode, touch the Main Menu icon , then select NIBP Settings . On the Intervals screen, change Set Mode to Stat, and then select the desired Stat Duration. See Intervals Settings for NIBP on page 88. The measurement site can also be changed using the action menu. WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference.
Chapter 8: NomoLine Capnography Overview Note: This feature is optional on Rad-97 devices. NomoLine capnography is available as an optional built-in addition to Rad-97, allowing monitoring of CO2, EtCO2, FiCO2, and RR. NomoLine capnography computes and analyzes the parameters based on the samples gathered from the patient's breathing circuit, via the NomoLine sampling line.
Rad-97 Chapter 8: NomoLine Capnography Figure 2. For optimal water handling, always use T-adapters with the sampling point in the center of the adapter, as shown above. Note: Using sample tubes or cannulas with an inner diameter greater than 1mm will increase NomoLine capnography’s total system response time. For ordering information about NomoLine sampling lines, cannulas, and related consumables, visit www.masimo.com.
Rad-97 Chapter 8: NomoLine Capnography Two different ways of scavenging the exhaust gas; through a ventilator reservoir (Figure 1) and directly to a scavenging system (Figure 2). In both cases, generate a deliberate leakage to avoid vacuum in the ISA’s exhaust gas tube. 3. 4. 5. 6. 7. Note: Returning the NomoLine capnography exhaust gas to the patient circuit is not allowed in the USA (Figure 3). Power up Rad-97. See Powering the Rad-97 ON and OFF on page 44.
Rad-97 Chapter 8: NomoLine Capnography Capnography Display Parameters and measurements may display in the Capnography window. NomoLine capnography parameters display by default as numeric values and as a graphical representation of the information acquired (a capnogram). Ref.* Feature Information 1 Capnography Action Menu See About the Action Menu on page 55. 2 Capnogram See Capnogram Display on page 135. 3 FiCO2 Display See FiCO2 Settings on page 91.
Rad-97 Chapter 8: NomoLine Capnography Action Menu To modify the capnography window options, select the Action Menu to toggle between Numeric and Trend display options. In Trend View, a parameter or measurement is displayed as a graph of its values over time. Below is an example of Capnography trend view: Capnogram Display The capnogram display is a waveform representation of a patient’s CO2 levels throughout inhalation and exhalation.
Rad-97 Chapter 8: NomoLine Capnography The FiCO2 display consists of two areas: Numeric Value FiCO2 is represented by a numeric value that ranges from 1 to 224 mmHg. When an FiCO2 value is not available, the value displays dashes (--). The FiCO2 value displays in conjunction with two smaller numeric values, the high alarm limit and low alarm limit. Trend FiCO2 values are represented by a trend that ranges from 0 to 225.
Rad-97 Chapter 8: NomoLine Capnography Numeric Value RR is represented by a numeric value that ranges from 1 to 149 breaths per minute (bpm). When an RR value is not available, the value displays dashes (--). The RR value displays in conjunction with two smaller numeric values, the high alarm limit and low alarm limit. Trend RR values are represented by a trend that ranges from 0 to 150.
Chapter 9: Video Conferencing Overview Note: This feature is optional on Rad-97 devices. When Rad-97 is connected to Masimo Patient SafetyNet, the optional camera and microphone located on the front panel (see Front View on page 38) allows Rad-97 to communicate both audibly and visually with Patient SafetyNet through video conferencing. This enables the clinician to communicate with the patient without being in the same room.
Rad-97 Control Chapter 9: Video Conferencing Description Touch the green Call button to: • Place call to Patient SafetyNet. • Accept call from Patient SafetyNet. Touch the red Call button to: • Reject call from Patient SafetyNet. • End call with Patient Safetynet. Touch the Minimize button to minimize the Video Call window (active call). The Call icon on the Main Screen changes from white to blue when minimized. • Indicates Patient SafetyNet is attempting to call Rad-97 (call not active).
Rad-97 Chapter 9: Video Conferencing Initiate a Call From Rad-97 1. 2. Touch the Call icon in the lower left corner of the Rad-97 Main Screen. See Controls on page 139. When the Video Call window appears, touch the green Call button to call Patient SafetyNet. 3. When the clinician accepts the call on the Patient SafetyNet view station, the video feeds appear for both the Patient SafetyNet station and Rad-97. Audio for both the Patient SafetyNet station and Rad-97 is provided.
Rad-97 Chapter 9: Video Conferencing Receive a Call From Patient SafetyNet 1. When Patient SafetyNet initiates a call to Rad-97, the Call icon on the Main Screen 2. turns Blue . Touch the Blue Call icon and the Video Call window appears. • 3. 4. Touch the green Call button to accept the call. • Touch the red Call button to reject the call. When a call is accepted, the Video feeds appear for both the Patient SafetyNet station and Rad-97 just as when placing a call, described earlier.
Rad-97 Chapter 9: Video Conferencing Alarms During Call When an alarm is active on Rad-97 while attempting, connecting, or during a call, an audible tone sounds and the status light illuminates relating to the severity of the alarm. See Chapter 13: Alarms and Messages on page 153 and About the System Status Light on page 59. To address the alarm, the Video Call window must be minimized. Touch the Minimize icon to minimize the Video Call window, and address the alarm. www.masimo.
Chapter 10: Admit to and Discharge from Patient SafetyNet The Admit/Discharge icon is located in the bottom left of the screen and allows clinicians to admit or discharge patient's on Masimo Patient SafetyNet directly from Rad-97. Icon Description Admit - Select to admit a patient. Discharge - Indicates a patient is currently admitted. Select to discharge admitted patient. Note: In order to use this feature, Masimo Patient SafetyNet software V5.0.6.5 or higher is required.
Rad-97 Chapter 10: Admit to and Discharge from Patient SafetyNet Fig. 1 4. Fig. 2 In the assignment section of the Patient menu (see Fig. 3), select the primary pager, then press Admit. Fig. 3 www.masimo.
Rad-97 Chapter 10: Admit to and Discharge from Patient SafetyNet Not Monitoring Message When the sensor is off the patient for an extended period of time, a Not Monitoring message will appear on the screen. Acknowledge the message by pressing Cancel or Discharge. Press Discharge to discharge the patient that is currently admitted on Rad-97, or press Cancel to keep the same patient admitted.
Chapter 11: Electronic Medical Records (EMR) Push The Electronic Medical Record (EMR) Push feature allows clinicians to send validated patient vitals data from Rad-97 directly to a Patient Data Management System, such as an Electronic Medical Record (EMR). Determining EMR Push is Active The EMR Push icon appears at the bottom of the Rad-97 main screen when the EMR Push feature is active. The EMR Push feature is active when a Rad-97 patient profile is connected to a Patient SafetyNet server.
Chapter 12: Third-Party Devices Bluetooth Flexible measurement expansion is possible through the Rad-97 Bluetooth connection. Rad-97 can display parameters and measurements captured by third-party technologies in an all-in-one view on Rad-97. When a third-party device is connected, Rad-97 automatically creates a window that displays all the data from that device on the Main Screen. USB To connect a USB device such as a barcode scanner, connect the device to the USB port on the rear of Rad-97.
Chapter 13: Alarms and Messages The following chapter contains information about alarms and messages. For more information, see Chapter 14: Troubleshooting on page 169. Alarm Interface Rad-97 alarms are presented to the user both audibly and visually. Alarms have different priority levels and come from different sources. Audible Alarms The following table describes audible alarm behaviors.
Rad-97 Chapter 13: Alarms and Messages Alarm Source/Example Explanation Window Level: The example shown here is an alarm in the lower NIBP Window. Note that the border of the Window illuminates yellow, and the explanation of the alarm is shown at the top of the Window (Systolic High). System Level: The example shown here is a "No Cable Connected" alarm. Note that the border of the entire Rad-97 display is illuminated, and the explanation of the alarm is shown in the Status Bar (No Cable Connected).
Rad-97 Chapter 13: Alarms and Messages Icon Appearance Description Visual Alarms There are currently no active alarms, but at least one alarm has been and is still silenced. No There is currently at least one active alarm that has not been Yes silenced. There is currently at least one active alarm, but all active alarms are silenced. Yes Silencing Alarms Alarms are conveyed in several ways: audibly, visibly, or both ways simultaneously.
Rad-97 Chapter 13: Alarms and Messages The following is an example of a typical medium priority alarm due to parameter limit violation. To silence audible alarms Touch the Alarm Silence icon or the highlighted value once to silence the audible alarm. The audible alarm is silenced for the Silence Duration. A countdown timer will display as shown below.
Rad-97 Chapter 13: Alarms and Messages Audio Pause Audio Pause temporarily suspends all audible alarms on Rad-97. When it is active, visual alarms are not impacted and will still display. The Audio Pause icon is located on the left side of the Status Bar; do not confuse it with the Sounds icon on the right side of the Status Bar. See About the Status Bar on page 52. By default, Audio Pause is inactive (alarms audible), and the icon appears in as follows: To activate Audio Pause, press the icon.
Rad-97 Chapter 13: Alarms and Messages a visual alert will display and a reminder tone will repeat every 15 minutes as long as the condition persists. If the SpO2 value drops below the ATA low alarm limit, an audible alarm will activate. Rapid Desat Alarm Protection The Rapid Desat feature is always active when ATA is enabled. This means that deep desaturations (5% or 10%) from the standard SpO2 low alarm limit generate audible and visual alarms.
Rad-97 Chapter 13: Alarms and Messages changes from patients’ baseline saturation levels. However, in select patient populations, substantial desaturation events that remain above a typical low alarm limit threshold may be preceded by a cycle of smaller transient desaturations over a limited period of time.
Rad-97 Chapter 13: Alarms and Messages *De Felice C, Latini G, Vacca P, Kopotic RJ. The pulse oximeter perfusion index as a predictor for high illness severity in neonates. Eur J Pediatr. 2002;161:561-562. Pi Delta From the Pi Delta menu screen, change any of the following options: Options Description Factory Default Settings Set Baseline Sets the Perfusion Index (Pi) value to be Off used as the baseline.
Rad-97 Chapter 13: Alarms and Messages Message Potential Causes Next Steps (Pulse CO-Ox) No Cable Connected • Cable not attached or not fully • inserted into the connector. (Pulse CO-Ox) Incompatible Cable • Not a proper cable. • Replace with a proper cable. (Pulse CO-Ox) Replace Sensor • Reusable sensor has used all its available patient monitoring time. • Replace sensor. • Sensor is non-functional. • Defective sensor.
Rad-97 Chapter 13: Alarms and Messages Message Potential Causes (Pulse CO-Ox) Replace Adhesive Sensor • When a single-patient-use • sensor is used, the adhesive portion of the sensor is non-functional, or the patient monitoring time of the adhesive portion of the sensor has expired. • Disposable sensor has less than 10% patient monitoring time remaining. • Replace with new disposable sensor. • When a single-patient-use sensor is used, the adhesive portion of the sensor is not connected.
Rad-97 Chapter 13: Alarms and Messages Message Potential Causes Next Steps (RAM) RAM Check Sensor • RAM unable to collect data through RAM Sensor. • Ensure proper sensor application. Check that no object is pulling on the sensor cable, which may cause the sensor to peel off. (RAM) Sensor Initializing • Device is checking the sensor for proper function and performance. • If values are not displayed within 30 seconds, disconnect and reconnect sensor.
Rad-97 Chapter 13: Alarms and Messages Message Potential Causes Next Steps Low SpCO SIQ • Indicates low signal confidence in the SpCO measurement displayed. • Ensure proper sensor application. Check sensor to see if it is working properly. If not, replace the sensor. See Successful Monitoring for SpCO on page 32. Low SpMet SIQ • Indicates low signal quality of SpMet measurement. • Ensure proper sensor application. Check sensor to see if it is working properly. If not, replace the sensor.
Rad-97 Chapter 13: Alarms and Messages Noninvasive Blood Pressure (NIBP) Messages The following section lists common NIBP messages, their potential causes, and next steps. Message Potential Causes Check Cuff (Weak Signal) • Weak or no signal measured during blood pressure measurement. Check Cuff (Artifact) • Motion may be affecting ability to take measurement. • Check that the hose is connected. Check Cuff (Out of Range) • Measurement is out of range.
Rad-97 Chapter 13: Alarms and Messages NomoLine Capnography Messages The following section lists common NomoLine capnography messages, their potential causes, and next steps. Message Potential Causes No Breath Detected • • Replace Sampling Line Next Steps Indicates no breath is detected within selected apnea timeout setting. • Confirm patient is properly connected to sampling line. • Check patient breathing circuit. • Replace sampling line.
Rad-97 Message www.masimo.com Chapter 13: Alarms and Messages Potential Causes atmospheric pressure is needed. 167 Next Steps • Verify gas reading with reference instrument or with calibration gas. • Ensure Rad-97 is placed in a well ventilated area. • Contact Masimo Technical Support. See Chapter 16: Service and Maintenance on page 203.
Chapter 14: Troubleshooting Troubleshooting Measurements The following section lists possible measurement symptoms, the potential cause, and next steps. For additional information, see Safety Information, Warnings and Cautions on page 13. Symptom Potential Causes Low SIQ message displayed (Low signal quality). • Sensor is damaged • or not functioning. • Improper sensor type or application. • • Excessive motion. • Low perfusion. www.masimo.
Rad-97 Chapter 14: Troubleshooting Symptom Potential Causes Next Steps Difficulty obtaining a reading. • Inappropriate sensor or sensor size. • Allow time for parameter reading to stabilize. • Improper sensor type or application. • Verify sensor type and size and re-apply sensor. See Directions for Use for sensor. • Low perfusion. • • Excessive motion artifact. Check if blood flow to the sensor site is restricted. • • Excessive ambient or strobing light.
Rad-97 Chapter 14: Troubleshooting Symptom Potential Causes Dimly Lit Parameters • Parameter Values Do Not • Correlate With Clinical • Assessment or Arterial Blood Gas Measurements Unexpected Parameter Readings www.masimo.com Next Steps Low signal quality. • Low perfusion. Sensor displacement. • Low SIQ or Pi values. • Inappropriate sensor size or sensor measurement location. 171 Assess the patient. • Verify sensor type and size and re-apply sensor. See Directions for Use for sensor.
Rad-97 Chapter 14: Troubleshooting Troubleshooting Rad-97 The following section lists possible Rad-97 symptoms, potential causes, and next steps. For more information, see Chapter 13: Alarms and Messages on page 153. Symptom Potential Causes Next Steps Device does not turn on • Depleted Battery. • • Internal failure. Check AC Power connection. • Contact Masimo Service. See Contacting Masimo on page 211. System failure technical alarm • active Internal failure. • Turn Rad-97 Off and On.
Rad-97 Chapter 14: Troubleshooting Symptom Potential Causes Touchscreen/Buttons do not respond when pressed • EMI (Electro Magnetic • Interference). • Internal failure. Battery run time significantly reduced Device does not detect that patient cable is connected Check device AC power is properly grounded. • Relocate the device from other devices that may cause electromagnetic interference. • Contact Masimo service. See Contacting Masimo on page 211. • Battery not fully charged.
Rad-97 Chapter 14: Troubleshooting Symptom Potential Causes Next Steps Nurse Call does not work • Nurse call connector not properly connected to the device. • Check Nurse call connector is fully connected to the device. • Nurse call port not configured correctly. • • Nurse call system not available. Check Nurse call port configuration. See Device Output on page 109. • • Internal failure. Check Nurse call system availability. • Contact Masimo service. See Contacting Masimo on page 211.
Rad-97 Chapter 14: Troubleshooting Symptom Potential Causes Next Steps Poor Video Quality (Camera) • • Verify network connection quality. If signal is poor, relocate the device for better signal strength. • Retry the call. • Toggle Wi-Fi Off and On. • Turn Rad-97 Off and On. • Verify network connection quality. If signal is poor, relocate the device for better signal strength. • Retry the call. • Toggle Wi-Fi Off and On. • Turn Rad-97 Off and On. • Enable video output on Rad-97.
Chapter 15: Specifications The following chapter contains specifications for the Rad-97. Pulse CO-Oximetry Specifications Display Range Measurement Display Range SpO2 (Functional Oxygen Saturation) 0% to 100% PR (Pulse Rate) 0 bpm to 240 bpm Pi (Perfusion Index) 0.00 to 20 PVi (Pleth Variability Index) 0 to 100 RRa (Respiration Rate) 0 rpm to 120 rpm SpHb (Hemoglobin) 0.0 g/dL to 25.0 g/dL 0 g/L to 250 g/L 0.0 mmol/L to 15.5 mmol/L SpCO (Carboxyhemoglobin) 0% to 99% SpMet (Methemoglobin) 0.
Rad-97 Chapter 15: Specifications Accuracy (ARMS*) [1] Oxygen Saturation (SpO2) No Motion [2] Adults, Pediatrics, Infants 3% Adults, Pediatrics, Infants 2% Neonates 3% (SpO2 from 60% to 80%) No Motion [3] (SpO2 from 70% to 100%) Motion [4] (SpO2 from 70% to 100%) All patient populations 3% Low perfusion [5] (SpO2 from 70% to 100%) All patient populations 2% Pulse Rate (PR) Range 25 to 240 bpm No motion All patient populations 3 bpm Motion [6] All patient populations 5 bpm Low Perfusion
Rad-97 Chapter 15: Specifications Total Hemoglobin (SpHb) [8] Range of 8 g/dL to 17 g/dL Adults, Pediatrics 1 g/dL Respiratory Rate (RRa) [9] Range of 4 to 70 bpm*** Adults, Pediatrics 1 bpm Range of 4 to 120 bpm*** Infants, Neonates 1 bpm Respiratory Rate (RRp)**** [10] Range of 4 to 70 rpm Adults, Pediatrics 1 rpm * ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements.
Rad-97 Chapter 15: Specifications Measurement ARMS Values for Disposable (RD SET Series) Sensors SpO2 Accuracy Range (%) ARMS (%) 90-100 1.53 70-100 1.15 The table below provides the upper 95% and lower 95% limits of agreement. The differences between measurements by the two methods are used to calculate the mean and standard deviation. The lower 95% limit of agreement is the mean minus 1.96 standard deviation and the upper 95% limit of agreement is the mean plus 1.96 standard deviation.
Rad-97 Chapter 15: Specifications Resolution Parameter Resolution SpO2 1% PR 1 BPM RRa 1 RPM* SpHb 0.1 g/dL 0.1 mmol/L 1 g/L SpCO 1% SpMet 0.1% SpOC 1.0 ml/dL RRp** 1 RPM * Breaths per minute is denoted as rpm on device display. ** Parameter currently not available in the U.S.A. and territories relying on FDA market clearance. Temperature Specifications Display Range Measurement Display Range Temperature 80.0 °F to 110.0 °F 26.7 °C to 43.3 °C www.masimo.
Rad-97 Chapter 15: Specifications Noninvasive Blood Pressure (NIBP) Specifications Display Range Measurement Patient Population Display Range Systolic Adult 40-260 mmHg Pediatric 40-230 mmHg Neonatal 40-130 mmHg Adult 20-200 mmHg Pediatric 20-160 mmHg Neonatal 20-100 mmHg Adult 26-220 mmHg Pediatric 26-183 mmHg Neonatal 26-110 mmHg Diastolic MAP Pulse Rate (PR) All 30-220 bpm Accuracy Pressure Transducer Between 0 mmHg and 300 mmHg ±3 mmHg Blood Pressure Meets ANSI/AAMI SP10 and
Rad-97 Chapter 15: Specifications Pressure Range Weight Patient Category Initial Pressurization Maximum Pressure Greater than 75 lbs (34 kg) Adult 160 mmHg 280 mmHg Between 15.4 - 75 lbs (7 - 34 kg) Pediatric 140 mmHg 280 mmHg Less than 15.4 lbs (7 kg) Neonatal 90 mmHg 140 mmHg NomoLine Capnography Specifications Display Range Measurement Display Range EtCO2 0% to 25% 0 kPa to 32.5 kPa 0 mmHg to 244 mmHg FiCO2 0% to 25% 0 kPa to 32.
Rad-97 Chapter 15: Specifications Standard Conditions The following accuracy specifications are valid for dry single gasses at 22 ± 5 °C and 1013 ± 40 hPa: Gas Range* Accuracy CO2 0 to 15 vol% ±(0.2 vol% + 2% of reading) 15 to 25 vol% Unspecified *All gas concentrations are reported in units of volume percent and may be translated into mmHg or kPa by using the reported atmospheric pressure.
Rad-97 Chapter 15: Specifications Data Output Specifications Fi and ET** Fi and ET are displayed after one breath and have a continuously updated breath average. The following method is used to calculate end-tidal (ET) values: The highest concentration of CO2 during one breathing cycle with a weight function applied to favor values closer to the end of the cycle.
Rad-97 Chapter 15: Specifications Gas or Vapor Gas Level CO2 4 vol% _1 ENF, ISO, SEV 4 5 vol% +8% of reading 3 DES 4 15 vol% +12% of reading 3 Xe (Xenon) 4 80 vol% -10% of reading 3 He (Helium) 4 50 vol% -6% of reading 3 HAL 4 Metered dose inhaler propellant 4 Not for use with metered dose inhaler propellants C2H5OH (Ethanol) 4 0.3 vol% _1 C3H7OH (Isopropanol) 4 0.
Rad-97 Chapter 15: Specifications Effects from Water Vapor Partial Pressure on Gas Readings When the breathing gas flows through the sampling line, the gas temperature will adapt to the ambient temperature before reaching the gas analyzer. The measurement of all gases will always show the actual partial pressure at the current humidity level in the gas sample. As the NOMO section removes all condensed water, no water will reach the NomoLine Capnography gas analyzer.
Rad-97 Chapter 15: Specifications Environmental Conditions Non-NIBP and Non-NomoLine Capnography models 10% to 95%, non-condensing NIPB and NomoLine Capnography models 15% to 95%, non-condensing Storage/Transport Humidity Non-NIBP and Non-NomoLine Capnography models 10% to 90%, non-condensing NIPB and NomoLine Capnography models 15% to 90%, non-condensing Operating Atmospheric Pressure 540 mbar to 1,060 mbar (540 hPa to 1060 hPa) Physical Characteristics Physical Characteristics Dimensions 22.
Rad-97 Chapter 15: Specifications Alarm Priority Alarm Status Color Audio Alarm Description Low Priority Solid yellow No audible alarms Alarm Characteristic Alarm Volume* Description High Priority: 75 dB (min) Medium Priority: 70 dB (min) * When volume is set to the highest level.
Rad-97 Chapter 15: Specifications Safety Standards Compliance ANSI/AAMI SP10 (NIBP) CAN/CSA C22.2 No.
Rad-97 Chapter 15: Specifications Connectors Connector Type Ethernet 10/100 Mbps Nurse Call 1/4 inch round female USB USB 2.0 NIBP Nib Male Bayonet NomoLine Capnography Gas Inlet Connector Wireless Specifications Communication (Wi-Fi) Type WLAN Radio: IEEE 802.11a/b/g/n Frequency 2.4 GHz - 802.11b/g/n: 2412-2472 MHz 5.0 GHz - 802.
Rad-97 Chapter 15: Specifications Communication (Bluetooth) Type Bluetooth Frequency 2402-2480 MHz Max Peak Output Power 12dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types DH5 Modulation Signals Analog and Digital Available Data Rates 1, 2, 3 Mbps Security and Authentication Encryption 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES Open System, Shared Key, Pre-Shared Key (PSK), 802.
Rad-97 Chapter 15: Specifications Radio Compliance Japan TELEC Article 2-1-19 Article 2-1-19-3 Article 2-1-19-3-2 Korea KN 301 489-1 V2.2.0 KN 301 489-17 V3.1.1 Guidance and Manufacturer's Declaration-Electromagnetic Emissions Guidance and Manufacturer's Declarations - Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.
Rad-97 Chapter 15: Specifications Guidance and Manufacturer's Declaration-Electromagnetic Immunity Guidance and Manufacturer's Declaration - Electromagnetic Immunity The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.
Rad-97 Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Power frequency (50 / 3 A/m 60 Hz) magnetic field. 3 A/m Power frequency magnetic fields should be at levels characteristic of typical location in a typical hospital environment.
Rad-97 Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Rad-97 Chapter 15: Specifications 100 11.7 1.8 3.5 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations.
Rad-97 Symbol Chapter 15: Specifications Description Symbol Description Non-Sterile Separate collection for electrical and electronic equipment (WEEE) CO2 Multigas Gas inlet Gas outlet Use-by date YYYY-MM-DD Body Weight Do not re-use/Single patient use only.
Rad-97 Symbol Chapter 15: Specifications Description Symbol Description Caution Not made with natural rubber latex Manufacturer Catalog number (model number) Date of manufacture Lot Code YYYY-MM-DD Number of Units Masimo reference number Storage temperature range Serial number Keep dry Fragile, handle with care Storage humidity limitation Do not use if package is damaged Atmospheric pressure limitation Equipotential Ground Terminal Nurse Call Interface SatShare Interface AC current
Rad-97 Symbol Chapter 15: Specifications Description Symbol Description RS-232 Interface Ethernet Analog Out Interface USB port Greater than China Restriction of Hazardous Substances Less than The names and content of the toxic and hazardous substances or elements shall be provided in the product instruction manual Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs Note: eIFU is not available in all countries.
Rad-97 Chapter 15: Specifications [6] Masimo rainbow SET technology with Masimo sensors has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. [7] The differences between measurements by the two methods are used to calculate the mean and standard deviation. The lower 95% limit of agreement is the mean minus 1.96 standard deviation and the upper 95% limit of agreement is the mean plus 1.96 standard deviation.
Chapter 16: Service and Maintenance The following chapter contains information about cleaning, battery operation, performance verification, service, repair, and warranty. Cleaning The Rad-97 is a reusable device. The device is supplied and is intended to be used non-sterile. WARNING: To avoid electric shock, always turn off the Rad-97 and physically disconnect the AC power and all patient connections before cleaning. CAUTION: To avoid permanent damage to the Rad-97, do not use undiluted bleach (5% 5.
Rad-97 Chapter 16: Service and Maintenance Before performing the following tests, do the following: • Connect the Rad-97 to AC power and fully charge the battery. • Disconnect any patient cables or pulse oximetry probes from the front of the Rad-97. • Disconnect nurse call, ethernet or USB cable from the rear of the Rad-97. Power-On Self-Test To conduct a Power-On Self-Test 1. 2. Power on the device by pressing the home button.
Rad-97 Chapter 16: Service and Maintenance Testing with the optional Masimo SET Tester To conduct a test with the optional Masimo SET® Tester 1. 2. 3. Turn off and then turn on the Rad-97. Use the Patient Cable connector on the Rad-97 to connect the Masimo SET® Tester to the Rad-97. See the directions for use that were provided with the Masimo SET® Tester. Nurse Call Setting Connections For maximum flexibility, either normally open or normally closed signals are available.
Rad-97 Chapter 16: Service and Maintenance 6. Connect the common lead of a digital multi-meter to contact 2 of the of the Nurse Call interconnection cable phone plug (as shown in the table). 7. Connect the positive lead of the digital multi-meter to contact 1 of the of Nurse Call interconnection cable phone plug (as shown in the table). Verify that the resistance is as shown in the table. 8. Trigger an alarm on the Rad-97 (for example, by connecting and disconnecting a sensor while measuring data).
Rad-97 Chapter 16: Service and Maintenance Procedure 1. 2. 3. 4. 5. 6. Enter NIBP menu, select "Calibration". Enter password: 4258 and touch "Calibration Test". Connect a manometer, volume and the hand bulb to the Module using "T" adapters and connection tubing. Touch the "Test" button on the display to start the calibration. Apply various pressures (between 0 mmHg and 280 mmHg) to the Module with the hand bulb. Verify that the Module pressure is equal to the manometer pressure (±3mmHg).
Rad-97 7. Chapter 16: Service and Maintenance Calibration is completed. Span Point Calibration Note: This section is provided as a reference and intended for qualified service professionals only. Calibration Steps 1. 2. 3. 4. 5. 6. 7. Enter NIBP menu and select "Calibration". Enter password: 4258 and select "Span Point Calibration". Connect a manometer, volume and the hand bulb to the Module using "T" adapters and connection tubing. Apply 250 mmHg to the module.
Rad-97 8. Chapter 16: Service and Maintenance If one of the overpressure values is not within the pass criteria above, return the module for service to an authorized service center. Maintenance Battery Operation and Maintenance The Rad-97 includes a lithium ion rechargeable battery. Before using the Rad-97 without the AC power connected, check the battery status indicator and ensure that the battery is fully charged. See Battery Charge Status Indicator on page 54.
Rad-97 1. 2. 3. Chapter 16: Service and Maintenance Empty the gas bottle completely. Once the gas bottle is empty, drill a hole in the bottle. CAUTION: Ensure that the bottle is completely empty of gas before drilling into the bottle. Write "Empty" on the bottle and follow local regulations for disposal of metallic (metal) gas bottles. Leakage Check To perform a leakage check, follow the steps below. 1. 2. 3. 4. 5. 6. 7.
Rad-97 Chapter 16: Service and Maintenance Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning on page 203. Make sure the equipment is fully dry before packing. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA number.
Rad-97 Chapter 16: Service and Maintenance Exclusions The warranty does not apply to any non-Masimo branded product or any software, even if packaged with the Product, or any Product that was: (a) not new or in its original packaging when supplied to purchaser; (b) modified without Masimo’s written permission; (c) supplies, devices, or systems external to the Product; (d) disassembled, reassembled, or repaired by anyone other than a person authorized by Masimo; (e) used with other products, like new senso
Rad-97 3. 4. Chapter 16: Service and Maintenance Purchaser may not disclose, publish, translate, release, distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Software or the written materials. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise dispose of the Product or the Software on a temporary basis.
Appendix: Concepts of Alarm Response Delay Concepts of Alarm Response Delay As with any pulse oximeter equipment, the audible and visual alarms are subject to alarm response delay, which is composed of Alarm Condition Delay and Alarm Signal Generation Delay. Alarm Condition Delay is the time from the occurrence of the triggering event to when the alarm system determines the alarm condition exists.
Additional Settings for RRp • 72, 74, 75 Additional Settings for SpHb • 75, 77 Additional Settings for SpO2 • 66, 67, 100 Admitting a Patient • 145 Alarm Interface • 153 Alarm Limit Test • 204 Alarms • 188 Alarms During Call • 143 Appendix Index 3 3D Alarms • 62, 64, 158 A About • 62, 110 About Alarms • 51, 99, 154, 158 About Desat Index • 66, 158 About Parameter Information • 66, 68, 69, 70, 72, 75, 78, 79, 81, 83, 85, 87, 90, 91, 92, 99, 110 About Pi Delta • 158, 159 About the Action Menu • 51, 55, 56,
Rad-97 Index Connecting to Wireless Network • 45 Connectors • 191 Contacting Masimo • 172, 173, 174, 211 Continuous Monitoring • 98 Contraindications • 11 Controls • 101, 139, 141 Cuff Selection and Placement • 125, 126, 127, 128 Customizing Trend View • 55, 56, 58, 110 Customizing Windows • 56, 59 Chapter 11 Electronic Medical Records (EMR) Push • 115, 149 Chapter 12 Third-Party Devices • 46, 106, 151 Chapter 13 Alarms and Messages • 143, 153, 171, 172 Chapter 14 Troubleshooting • 153, 169, 204 Chapt
Rad-97 Index H Features • 38 FiCO2 Alarms • 91, 92 FiCO2 Display • 135 FiCO2 Settings • 90, 91, 134 Front View • 38, 132, 139 Functional Oxygen Saturation (SpO2) • 26 Home • 62, 96, 99, 112, 117 I In Vivo Adjustment Overview • 65, 68, 77, 79, 80 In Vivo for SpCO • 66, 79, 80 In Vivo for SpHb • 66, 75, 77 In Vivo for SpMet • 66, 78, 79 In Vivo for SpO2 • 66, 68 Indications for Use • 11 Initial Battery Charging • 43, 44, 209 Initiate a Call From Rad-97 • 113, 141 Interfering Gas Vapor Effect • 185 Interv
Rad-97 Index N P Navigating the Main Menu • 63 NIBP Air Leak Test • 207 NIBP Display • 123 NIBP Module Calibration • 206 NomoLine • 131 NomoLine Capnography • 15, 20, 22, 23, 209 NomoLine Capnography LEGI Indicator • 39, 60, 133, 137 NomoLine Capnography Messages • 166 NomoLine Capnography Sampling Line Connection • 45 NomoLine Capnography Settings • 61, 90 NomoLine Capnography Specifications • 183 Noninvasive Blood Pressure • 14, 20, 206 Noninvasive Blood Pressure (NIBP) Messages • 165 Noninvasive Bloo
Rad-97 Index R Screen Orientation • 96, 100 Selected Network • 102, 103 Sending Patient Data to the EMR • 149 Sensitivity Modes Overview • 55, 56, 81, 169, 171 Sensor • 34 Side and Top Views • 41, 43, 59 Signal Extraction Technology® (SET®) • 25 Signal IQ • 28 Signal IQ Indicators • 82, 163 Signal Processing • 34 Silencing Alarms • 52, 155 Sleep Study • 67, 99, 117 Sounds • 53, 62, 82, 95, 108, 157, 204 Span Point Calibration • 208 SpCO Alarms • 79, 80 SpCO Settings • 65, 79 SpCO, SpMet, and SpHb Measure
Rad-97 Index Successful Monitoring for SpO2, PR and Pi • 26 Symbols • 197 SYS/DIA Alarms • 85, 86 SYS/DIA Settings • 85, 123 System Setup • 132 Wi-Fi • 45, 53, 96, 102, 174 Wireless Specifications • 191 Z Zero Point Calibration • 207 Zeroing • 60, 210 T Temperature Alarms • 83 Temperature Settings • 61, 83, 121 Temperature Specifications • 181 Temperature Window • 121 Testing with the optional Masimo SET Tester • 205 Third-Party Devices • 46 Touchscreen Function Test • 204 Trend Settings • 110 Trends •
www.masimo.
