Signal Extraction Pulse CO-Oximeter with Rainbow Technology OPERATOR’S MANUAL
Signal Extraction Pulse CO-Oximeter OPERATOR’S MANUAL
The Radical-7 Pulse CO-Oximeter Operating Instructions provide the necessary information for proper operation of all models of the Radical-7 Pulse CO-Oximetry system. There may be information provided in this manual that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of the Radical-7 Pulse CO-Oximeter are prerequisites for its proper use.
NON-INVASIVE TOTAL HEMOGLOBIN (SpHb) ACCURACY COMPARED TO INVASIVE LABORATORY METHODS* In 492 comparisons of non-invasive total hemoglobin (SpHb) and invasive hemoglobin (tHb) measurements from a laboratory CO-Oximeter, SpHb accuracy was as follows: ■ 0.90 correlation ■ 0.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ ■ Patient Safety - If a sensor is damaged in any way, discontinue use immediately. Always remove the sensor from the patient and completely disconnect the patient from the Radical-7 before bathing the patient. ■ Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. ■ Do not use the Radical-7 or sensors during magnetic resonance imaging (MRI) scanning.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ ■ ■ Severe anemia ■ Low arterial perfusion ■ Motion artifact Inaccurate SpHb and SpOC readings can be caused by: ■ Intravascular dyes such as indocyanine green or methylene blue ■ Externally applied coloring (such as nail polish) ■ Elevated levels of Bilirubin ■ Low arterial perfusion ■ Motion artifact ■ Low arterial oxygen saturation levels ■ Hemoglobin synthesis disorders ■ Hemoglobinopathy ■ Peripheral vascular disea
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other instruments in the vicinity. However, there is no guarantee that interference will not occur in a particular installation.
vi Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual
Table of Contents SECTION 1 - OVERVIEW About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Warnings, Cautions and Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents SECTION 4 - OPERATION Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 General Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Successful Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents SECTION 4 - OPERATION (CONTINUED) TrendCom Utility Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TrendCom Utility Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Erasing Trend Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Trend Data Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents SECTION 8 - SENSORS & PATIENT CABLES (CONTINUED) Masimo SpO2 Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 ReSposable Pulse CO-Oximeter Sensor System . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Red Direct Connect Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 ® LNOP Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview 1 About This Manual This manual explains how to set up and use the Radical-7™ Pulse CO-Oximeter containing Masimo Rainbow® SET® technology. Important safety information relating to general use of the Pulse CO-Oximeter appears before this introduction. Other important safety information is located throughout the manual where appropriate. Read the entire safety information section before you operate the monitor.
1 Overview Warnings, Cautions and Notes Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: A WARNING is provided when actions may result in a serious outcome (i.e., injury, serious adverse affect, death) to the patient or user. Look for text in a gray shaded box. Sample of Warning: WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.
Overview 1 Product Description The Radical-7 Pulse CO-Oximeter is a noninvasive, arterial oxygen saturation, total hemoglobin concentration and pulse rate monitor. The Radical-7 Pulse CO-Oximeter can be used as either a Handheld or a Standalone monitor. The Radical-7 Pulse CO-Oximeter features a backlit Liquid Crystal Display (LCD) that continuously displays numeric values for SpO2, SpMet®, SpCO®*, SpHb®, SpOC™*, pulse rate, Perfusion Index (PI) and Pleth Variability Index (PVI).
1 Overview INDICATIONS FOR USE The Radical-7 Pulse CO-Oximeter and accessories are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by a SpO2 sensor), carboxyhemoglobin and methemoglobin concentrations expressed in percentage (SpCO and SpMet) and total hemoglobin concentration expressed in grams per deciliter (SpHb).
1 Overview through a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as percentage value for the SpMet. SpHb GENERAL DESCRIPTION Pulse CO-Oximetery is a continuous and non-invasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make the SpHb measurement.
1 1 Overview light through the site to a diode (detector). Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25 mW.
Overview 1 temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. In the case of SpCO, different results are also expected if concentration of methemoglobin in the blood gas sample is abnormal (greater than 2% for methemoglobin concentration). High levels of bilirubin may cause erroneous SpO2, SpMet, SpCO and SpHb readings.
1 Overview SpCO, SpMet AND SpHb MEASUREMENTS DURING PATIENT MOTION The Radical-7 displays measurements of SpCO, SpMet and SpHb during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable during excessive motion.
System Description 2 Introduction The Radical-7 provides the functionality of three instruments in one: ■ The Radical-7 is a fully featured Handheld Pulse CO-Oximeter. ■ The Radical-7 is a fully featured Standalone Pulse CO-Oximeter. ■ The Radical-7 interfaces to the SpO2 input module of multiparameter patient monitors* to upgrade conventional pulse oximetry technology to Masimo SET technology. The Handheld portion of the Radical-7 contains the majority of the Pulse CO-Oximeter features.
2 System Description Radical-7 Pulse CO-Oximeter Handheld The Handheld Radical-7 Pulse CO-Oximeter provides most of the functionality of the Pulse CO-Oximeter. All user input and displays are controlled by this part of the Radical-7 Pulse CO-Oximeter system. The patient cable connects into the connector on the Handheld instrument. The Handheld is battery powered and can be used either as a transport monitor or as a Handheld Pulse CO-Oximeter for spot checks.
System Description 2 HANDHELD FRONT PANEL (CONTINUED) 1 HANDHELD RELEASE BUTTON 2 97 The functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO2. The upper and lower SpO2 alarm limits are also displayed next to the SpO2 measurement. When a sensor is not connected to a patient and SpO2 during pulse search, the display will show dashed lines and MEASUREMENT the message "Sensor Off" will appear at the top of the display DISPLAY screen.
2 System Description HANDHELD FRONT PANEL (CONTINUED) 50 5 11 12 10.0 The SpCO Alarm Limits Display shows the upper and lower alarm SpCO ALARM limits. When the measured value is outside of the alarm limits, the LIMITS DISPLAY SpCO measurement display flashes and an alarm will sound. SpHb ALARM LIMITS DISPLAY The measurement of total hemoglobin concentration levels is displayed in units of grams per deciliter (g/dL) or milimoles per liter (mmol/L).
System Description 2 HANDHELD FRONT PANEL (CONTINUED) 22 13 SENSOR 4 Hrs SpOC* MEASUREMENT DISPLAY SENSOR TIME 23 10/11/06 12:23:11am 24 5 25 TIME AND DATE INDICATOR The measurement of total oxygen content is displayed in units of milliliter per deciliter. Sensor Time displays the amount of time remaining (for SpHb Rainbow Reusable sensors) in the lower, right-hand corner of the screen. The Sensor Time is displayed in “X” Hrs” or “XX Min.
2 System Description MAIN SCREEN TREND GRAPH DISPLAY The Radical-7 Pulse CO-Oximeter provides a Trend Graph display function, which allows the user to quickly check the trend of each parameter/measurement. This is done by repeatedly pressing down on the Trend Graph control button to step through and select the desired parameter/measurement. Once the parameter/measurement is selected, the numeric value is highlighted and the selected parameter/measurement is displayed above the trend graph. 10.
2 System Description HANDHELD BACK PANEL The Handheld back panel features the interconnection to the Docking Station, an accessory mount for the pole clamp accessory and access to the Handheld battery pack. 1 2 3 1 DOCKING STATION CONNECTOR The Radical-7 Handheld interfaces with the Docking Station through this connector. 2 POLE CLAMP ACCESSORY HOLDER The optional Pole Clamp accessory attaches to this holder. See the Directions for Use of the Pole Clamp accessory for attachment instructions.
2 System Description Radical-7 Pulse CO-Oximeter Standalone When the Radical-7 Pulse CO-Oximeter Handheld is placed into the Docking Station, the Radical-7 Pulse CO-Oximeter becomes a full-featured standalone instrument. The Radical-7 Pulse CO-Oximeter Standalone acts as a battery charger for the Handheld instrument and has AC power connection capabilities. If the AC power from the wall outlet is temporarily interrupted, then the battery in the Handheld instrument will allow continuous operation.
System Description 2 STANDALONE FRONT PANEL The following figure and corresponding text review the features of the Radical-7 Standalone instrument. 10.0 17 7 SpHb g/dl ----- ----- 13 SpOC ml/dl 1 DOCKING STATION BATTERY CHARGING INDICATOR The Docking Station Battery Charging Indicator is illuminated when the Docking Station battery is charging. The indicator blinks just prior to charging.
2 System Description STANDALONE BACK PANEL 1 2 5 3 4 1 SERIAL OUTPUT CONNECTOR Use the Serial Output Connector with a ferrite bead installed to connect a serial instrument, including a serial printer, a monitoring system or PC to the Radical-7 Pulse CO-Oximeter. The data is provided in standard RS-232C format. See Section 7, Serial Interface Specifications. All external instrument connections to the Serial Output Connector must be IEC-60950 compliant.
System Description 2 SYMBOLS The following symbols are found on the Radical-7 Pulse CO-Oximeter, Docking Station or packaging and are defined below: NOTE: Some of the interfaces and symbols are not available on all versions of the Docking Station.
2 System Description Radical-7 Monitor Interface In addition to being a full-featured Handheld and Standalone Pulse CO-Oximeter, the Radical-7 Pulse CO-Oximeter’s unique SatShare interface links the Radical-7 Pulse CO-Oximeter to most existing multiparameter patient monitors through the pulse oximetry patient cable or SpO2 input connector. 76 97 10.
Setup 3 Introduction Before the Radical-7 Pulse CO-Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be fully charged. Unpacking and Inspection Remove the instrument 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.
3 Setup INITIAL BATTERY CHARGING Before use, the Radical-7 Pulse CO-Oximeter Handheld battery and the optional Docking Station battery need to be fully charged. To charge the batteries: 1. Attach the Handheld instrument to the Docking Station. 2. Plug in the AC power cord to power entry module. Make sure it is securely plugged in. 3. Plug the AC power cord into an AC power source. 4. Verify that the batteries are charging.
3 Setup Monitor Setup The Radical-7 Pulse CO-Oximeter maintains three types of default values, which the instrument will automatically revert to after a power cycle: ■ Factory – these options are restored to factory values. ■ Custom – these settings can be changed by the user and retained through the power cycle. ■ Adult / Neo – these settings can be selected to revert to factory or hospital-defined values (for Adult or Neonatal) after a power cycle.
3 Setup CUSTOM (USER) DEFINED SETTINGS (CONTINUED) CONFIGURABLE SETTING FACTORY DEFAULT SETTING OPTION TREND DISPLAY PARAMETERS/ MEASUREMENTS Set to %SpO2 + BPM TREND PERIOD Set to 1 Hr SpHb TREND Set to Yes LOW SpO2 ALARM LIMIT Set to 0 SpHb AVERAGING SpMet HIGH/LOW ALARM LIMIT SpCO HIGH/LOW ALARM LIMIT SpHb HIGH/LOW ALARM LIMIT PI HIGH/LOW ALARM LIMIT PVI HIGH/LOW ALARM LIMIT SMART TONE PI AVERAGING PVI AVERAGING DISPLAY MEASUREMENT SpHb PRECISION SpHb CAL Set to Medium Set to High: 3.
3 Setup SatShare Setup The Radical-7 Pulse CO-Oximeter has been proven to be accurate during patient motion and low perfusion conditions. Saturation and pulse rate values from the Radical-7 Pulse CO-Oximeter may be displayed on a multiparameter monitor through the SatShare feature. The SatShare feature provides an ideal, simulated waveform corresponding to the measured saturation and pulse rate values determined by the Masimo SET technology.
3 Setup SATSHARE SETUP (CONTINUED) 7. While in the SatShare mode, if there are any significant discrepancies between the readings from the Radical-7 Pulse CO-Oximeter and those on the monitor displaying the values obtained from SatShare, the values reported by the Radical-7 Pulse CO-Oximeter are to be considered the correct values. 8.
Setup 3 THE RADICAL-7 REVERTS TO INTERFACE ALARM SpO2/BPM “Yes” DURING POWER INTERRUPTIONS OR WHEN THE SATSHARE CONNECTION IS LOST OR THE Instrument BECOMES SEPARATED FROM THE DOCKING STATION. THIS ENSURES THAT THE RADICAL-7 PROVIDES AUDIBLE ALARMS FOR SpO2 AND PULSE RATE WHEN THE CONNECTION TO THE INTERFACED SYSTEM BECOMES COMPROMISED. Philips VueLink Setup CAUTIONS: SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED.
3 Setup 5. In order for the plethysmographic waveform to be displayed on the Spacelabs screen and for the Spacelabs monitor to indicate the alarm conditions measured by the Pulse CO-Oximeter, the user must configure the Spacelabs monitor. Refer to the Spacelabs monitor Operator’s Manual for complete instructions. 6. The Radical-7 Pulse CO-Oximeter can be set up to audibly indicate all patient alarms while communicating with the Spacelabs Flexport module.
Operation 4 Introduction To operate the Radical-7 Pulse CO-Oximeter effectively, the instrument must be set up properly and the operator must: Know how the Pulse CO-Oximeter derives its readings (see Section 1, Pulse CO-Oximetry). Be familiar with its controls, components and operation. Understand its status and alarm messages (see Section 5, Alarm Identification, System Messages and Section 6, Troubleshooting). Basic Operation GENERAL SETUP AND USE 1. 2. 3. 4. 5. 6. 7. 8. 9.
4 Operation GENERAL SETUP AND USE (CONTINUED) 10. Verify that the patient alarms are functional by setting the high and low SpO2, SpMet, SpCO, SpHb, PI, PVI, and pulse rate alarm limits beyond the patient readings. An alarm tone sounds. The violated alarm limit and reading flash on the display. The red alarm indicator flashes on the Docking Station (standalone operation). 11. Verify the sensor alarms are functional by removing the sensor from the sensor site.
Operation 4 averaging times delay the response of the oximeter and reduce the measured variations of SpO2 and pulse rate. MASIMO SENSORS Before use, carefully read the Masimo sensor Directions for Use. Use only Masimo sensors for pulse oximetry or pulse CO-Oximetry measurements. Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly.
4 Operation SENSOR TIME REMAINING The Radical-7 displays the amount of time remaining for SpHb Rainbow Reusable sensors (refer to Section 8, Rainbow Reusable Sensors) in the lower, right-hand corner of the screen. While a patient is monitored, the amount of time decreases until the remaining time shows “0 Min”. Refer to the specific sensor DFU for additional information. NOTE: Sensor Time will not be displayed for SpHb Rainbow Adhesive Sensors because they have been designed for single patient use only.
4 Operation ■ ■ ■ ■ ■ Intravascular dyes such as indocyanine green or methylene blue. Low arterial perfusion. Low arterial oxygen saturation levels. Elevated Total Bilirubin levels. Motion artifact. NUMERIC DISPLAY - SpHb A stable SpHb reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site.
4 Operation SIGNAL INDICATION AND QUALITY INDICATOR (SIQ) The Radical-7 Pulse CO-Oximeter display provides a visual indicator of the plethysmogram signal quality and an alert when the displayed SpO2 values are not based on adequate signal quality. The signal quality indicator displayed on the Radical-7 Pulse CO-Oximeter is called the SpO2 SIQ. The SpO2 SIQ can be used to identify the occurrence of a patient’s pulse and the associated signal quality of the measurement.
Operation 4 value may be compromised. To acknowledge the Low SpHb SIQ state and display the number, icon. A numeric value will display for both SpHb and for SpOC. The “SpHb” parampress the eter label will continue to flash to indicate the monitor is in a Low SpHb SIQ state. If the user does not acknowledge the Low SpHb SIQ state, “---” will continue to be displayed instead of a number value. To access the Max/APOD button and change the Sensitivity setting in icon is displayed, press the “next page” icon.
4 Operation SENSITIVITY Three sensitivity levels enable a clinician to tailor the response of the Radical-7 to the needs of the particular patient situation. They are as follows: ■ Normal Sensitivity – This is the recommended mode for patients that are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as an intensive care unit (ICU).
4 Operation Touch Key Control Button and Icons The touch key control buttons are the four dark grey control buttons to the right of the Handheld display. To select a touch key icon, press and release the dark gray control button to the right of the icon, or below the icon in the vertical orientation.
4 Operation Simplified User Interface By enabling the Simplified User Interface, users are exposed to only the most common Pulse CO-Oximeter features, while all the remaining settings remain available behind password protection. FIRST PAGE NEXT MENU PAGE Press the Next Menu Page button to access the second page of selections. Press and hold the button for 8 seconds to toggle between Traditional User Interface and the Simplified User Interface.
Operation 4 Navigating the Main Menu When the main menu is accessed, the plethysmographic and Signal IQ waveform displays are replaced with the main menu items. The touch key icons, displayed along the right edge of the LCD display, are also replaced by the menu access icons. When the main menu is accessed, the monitor remains functional and the saturation and pulse rate numbers will continue to be displayed.
4 Operation MENU TREE SpO2 High/Low limit Pulse rate High/Low limit (bpm) SpMet High/Low limit SpCO High/Low limit SpHb High/Low limit ALARMS PI High/Low limit PVI High/Low limit Silence Volume Delay (volume delay) Mode Landscape 1 ROTATE SCREEN Vertical 1 Landscape 2 Vertical 2 View Trend DISPLAY Language Default Vertical Layout Time (hour/minute/seconds) Time display format Day CLOCK Month Year Format (mm/dd/yy) Display Clock Software Versions ABOUT 4-12 More Line Frequency Sensor Time NAC LM
4 Operation Line Frequency (50 Hz, 60 Hz) Rapid Desat Limit (Off, -5, -10) Display Measurement (SpOC, None) CONFIG Enter password (refer to Section 4 Password Operation) SpHb Unit of Measurement (g/dL, mmol/L) SpHb Precision (0, 0.1 or 0.
4 Operation Alarms Check alarm limits each time the Pulse CO-Oximeter is used to ensure that they are appropriate for the patient being monitored. An audible alarm and a flashing alarm icon (and indicator light) will occur when an alarm limit is exceeded. It is best that the operator be within a minimum of 10 feet from the instrument. MENU ITEMS SpO2 HIGH LIMIT DESCRIPTION The SpO2 high alarm limit can be set anywhere between 2% and 99%, then “---” with a 1% step size.
4 Operation MENU ITEMS DESCRIPTION The SpCO low alarm limit can be set as “---”, or anywhere between 1% and 97%, with a 1% step size. In the “----” (off) setting, the alarm can be turned off completely. SpCO LOW LIMIT SpHb HIGH LIMIT SpHb LOW LIMIT PI HIGH LIMIT PI LOW LIMIT NOTE: The low alarm limit must be set below the high alarm setting.
Operation 4 Alarms (continued) MENU ITEMS DESCRIPTION This menu allows the user to set the alarm silence period for SpO2, SpMet, SpCO, SpHb, PI, PVI and pulse rate. An alarm is silenced by pressing the Alarm Silence button on the front panel. 30, 60, 90,120 SECONDS The alarm silence can be set for these durations. As an indicator that the alarm system is silenced, the Alarm Status Indicator is shown as a bell with a slash through it.
4 Operation Alarms (continued) This menu allows the users to set an audible saturation delay. The delay can be set to either 0, 5,10 or 15 seconds. The delay setting only affects saturation alarms indications. DELAY NOTE: In “Custom” mode (see Section 4, Operation) the instrument will retain the Alarm Delay setting after a power cycle. In “Neo” or “Adult” mode (see Section 4, Operation) the instrument will reset the Alarm Delay to the hospital specified setting after a power cycle.
4 Operation Rotate Screen MENU ITEMS DESCRIPTION LANDSCAPE 1 The viewing screen will be in a horizontal fashion when the Radical-7 is in the upright, horizontal position. VERTICAL 1 The viewing screen will be in a vertical fashion when the Radical-7 is in the upright, vertical position. LANDSCAPE 2 The viewing screen will be in an inverted horizontal fashion (rotated 180o) when the Radical-7 is in the upright, horizontal position.
4 Operation MENU ITEMS TREND DESCRIPTION This allows the user to select and view the Trend data between: ■ %SpO2 ■ Pulse Rate (BPM) ■ Perfusion Index (PI) ■ Pleth Variability Index (PVI) ■ Methemoglobin (MET) ■ Carboxyhemoglobin (CO) ■ Total Hemoglobin (HB) ■ SpOC (OC) NOTE: These parameters/measurements are viewed when utilizing the Trend Display function and not the Trend Graph function. LANGUAGE Allows the user to select the language displayed on the screen.
4 Operation Clock MENU ITEMS TIME TIME FORMAT DAY MONTH YEAR DAY FORMAT DISPLAY CLOCK DESCRIPTION Set the time - hour, minutes and seconds - in 24 hour format. Set the format of the time display as it will be shown on the front panel. Available options are 12 hour (default) and 24 hour display. Set the numerical day. Set the numerical month. Set the numerical year. Set the format of the date display as it will be shown on the front panel. Available options are mm/dd/yy (default) and dd/mm/yy.
Operation C o n f i g MENU ITEMS 4 DESCRIPTION SpHb Precision Set to 0 (whole numbers), 0.1 or 0.5 increments. This feature allows the user to set the decimal for SpHb. Factory default is 0.1. SpHb Cal Set to SpHb or SpHbV. This feature provides an Arterial (SpHb) or Venous (SpHbV) value that displays on the main screen. NOTE: The hemorheologic profile of arterial and venous blood samples can vary1.
4 Operation MENU ITEMS DESCRIPTION INTERFACE ALARMS SpO2/BPM During SatShare, Patient SafetyNet, Philips Vuelink, Spacelabs Flexport and RadNet operation, the audible alarms for SpO2 can be enabled or disabled by selecting Yes or No. All other parameters/measurements will be actively monitored by the instrument. The Rainbow parameters/measurements cannot be turned off with this feature. Yes setting: allows SpO2 and pulse rate audible alarms at the Radical-7 and the interfaced system.
Operation 4 3D ALARM Refer to Section 5, 3D ALARM. Output NOTE: The output menu selections are only available when the Radical-7 Handheld is interfaced to the Docking Station. MENU ITEMS DESCRIPTION The following serial output modes are supported. All serial output is RS-232 based. See the interface specifications in Section 7, Specifications. ASCII 1 ASCII text data is sent to the serial interface at one-second intervals.
4 Operation Output (continued) MENU ITEMS ANALOG1 OR ANALOG 2 (CONTINUED) NURSE CALL DESCRIPTION 0V OUTPUT A 0 Volt calibration signal is mapped to the analog output. Use this signal for calibration of recording instruments. (0 Volts represents a saturation of 0% and a pulse rate of 0 bpm). 1V OUTPUT A 1 Volt calibration signal is mapped to the analog output. Use this signal for calibration of recording instruments. (1 Volt represents a saturation of 100% and a pulse rate of 250 bpm).
4 Operation Service NOTE: The Service menu selections are only available when the Radical-7 Pulse CO-Oximeter Handheld is interfaced to the Docking Station. Only qualified Biomedical or Clinical Engineering department personnel should access the service menu. See Section 4, Password Operation, on how to enter the password. MENU ITEMS DESCRIPTION HANDHELD BATTERY DISCHARGE To deep discharge the Handheld battery, select this menu item.
4 Operation Trend Display Once the Trend Display touch key icon is selected, the trend data is displayed on the main screen. The Radical-7 Pulse CO-Oximeter stores one data set of SpO2, pulse rate, SpMet, SpCO, SpHb, SpOC, PI, PVI and system messages in a dedicated memory area. Depending on the Trend Period, a setting for how often the data is stored in the trend memory, the Radical-7 Pulse CO-Oximeter can store between 72 hours and > 10 days of trend data.
Operation 4 TREND DISPLAY SCREEN (CONTINUED) 1 The top line on the trend display shows the time scale of the trend graph, followed by the starting date, starting time and end time of the data set that is displayed on the screen. 2 The second line of the display shows the minimum, maximum and average SpO2, SpMet, SpCO, SpHb, SpOC, PI, pulse rate or PVI measurements contained in the displayed data set (excluding zero measurements).
4 Operation SECOND PAGE NEXT MENU PAGE Press the Next Menu Page button to access the next page of menu selections. ZOOM Press the Zoom button to change the time scale of the trend view. The available time scales are 24 hrs, 12 hrs, 8 hrs, 4 hrs, 2 hrs, 1 hr, 30 minutes, 10 minutes, 1 minute and 20 seconds. The Zoom button uses the last recorded data point as the zoom reference point. The last recorded data point is always shown as the right-most data point on the display.
Operation 4 TREND SETUP This menu allows the user to set the default trend settings or download the trend data. The default settings are used to scale the trend graphs when the trend data button, located on the main display, is accessed. MENU ITEMS DESCRIPTION %SpO2 MAX SCALE %SpO2 MIN SCALE PR AUTO SCALE (BPM) Sets the %SpO2 scale to automatically adjust to the data presented. Sets the maximum scale of the SpO2 trend graph. Sets the minimum scale of the SpO2 trend graph.
4 Operation TREND SETUP (CONTINUED) MENU ITEMS DESCRIPTION SERIAL DUMP To send all the data that is stored in trend memory to the serial port select the Serial Dump option. Use this option to communicate the stored data set to trend graphing software applications. TREND ACTION TREND PERIOD SpHb TREND ANALOG DUMP To send all the data that is stored in the trend memory to the analog output select the Analog Dump option. Use this option to print the trend information on an analog chart recorder.
Operation 4 Trend Setup and Use INTRODUCTION The Radical-7 can store up to 72 hours of trend data captured at 2 second intervals. The trend data can then be transferred to a PC for evaluation. A serial cable is required to connect the Radical-7 to a PC. Trend data is stored in non-volatile memory, so it is not erased when the instrument is shut off. A trend data download is initiated using the TrendCom utility which downloads the trend data and saves it to an ASCII text (.
Operation 4 6. Name the file. 7. Save the file to the appropriate folder. Radical-7 trend information will consist of Date, Time, SpO2, Pulse Rate and Perfusion Index. Trend information will include Pleth Variability Index, SpCO, SpMet and/or SpHb, if the parameters are installed. D) Disconnecting the Cable 1. Disconnect the USB-Serial or Serial-Serial cable from the instrument and PC. (See the specific cable's Directions for Use for instructions on attaching the patient cable to the instrument.
4 Operation SAMPLE TREND OUTPUT 07/21/08 07/21/08 07/21/08 07/21/08 07/21/08 07/21/08 07/21/08 07/21/08 09:56:08 09:56:10 09:56:12 09:56:14 09:56:16 09:56:18 09:56:20 09:56:22 SpO2=000 SpO2=000 SpO2=097 SpO2=096 SpO2=098 SpO2=000 SpO2=000 SpO2=096 PR=000 PR=000 PR=069 PR=074 PR=078 PR=000 PR=000 PR=078 PI=00.00 PI=00.00 PI=04.69 PI=02.28 PI=03.64 PI=00.00 PI=00.00 PI=02.
Operation 4 SatShare Operation When the SatShare cable is connected to the Radical-7 Pulse CO-Oximeter and to a multiparameter patient monitor, the Radical-7 Pulse CO-Oximeter automatically starts to operate in the SatShare mode. In the SatShare mode, Radical-7 Pulse CO-Oximeter operates as follows: 4-34 ■ All visual alarms remain active. ■ All audible alarms may be disabled by software configuration of the Radical-7 Pulse CO-Oximeter. Refer to Section 4, Alarms.
Operation 4 SatShare Operation (continued) CAUTIONS: ■ SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS CORRESPONDING TO THE CALCULATED SATURATION AND PULSE RATE VALUES AND DO NOT CONTAIN ALL OF THE INFORMATION CONTAINED IN PHYSIOLOGICAL WAVEFORMS. THE MULTIPARAMETER PATIENT MONITOR DECODES THESE SIGNALS INTO SATURATION AND PULSE RATE VALUES. ■ DURING SATSHARE OPERATION, THE AUDIBLE ALARMS MAY BE MUTED ON THE RADICAL-7 PULSE CO-OXIMETER.
4 Operation Home Mode Operation The Radical-7 Pulse CO-Oximeter can be placed into the Home Mode to protect unqualified users from changing the Radical-7 Pulse CO-Oximeter alarm settings and operation. Entering a password does not automatically reset the Radical-7 Pulse CO-Oximeter to the Normal operating mode. In the Home Mode, a password is required to access the menu system and the touch key control buttons and icons.
5 Alarms and Messages Alarm Identification The Radical-7 visually and audibly indicates alarm conditions that the system detects. Audible alarms may be silenced, without affecting the operation of visual alarms. Three levels of alarm priority are implemented: high, medium and low priority. The following table outlines the alarm priority specifications.
Alarms and Messages 5 System Messages The following chart alphabetically lists all system messages displayed on the LCD screen. The cause of the message, and the action(s) to be taken are also shown. The operator should become thoroughly familiar with this information before using the Pulse CO-Oximeter for patient monitoring. MESSAGE REPLACE SENSOR POSSIBLE CAUSE(S) SpHb reusable sensor has used all its available monitoring time. RECOMMENDATION Replace sensor. Sensor is non-functional.
Alarms and Messages MESSAGE 5 POSSIBLE CAUSE(S) RECOMMENDATION REPLACE ADHESIVE When a single patient use sensor is used, the adhesive portion of the sensor is non-functional, or the life of the adhesive portion of the sensor has expired. (Applies to Rainbow ReSposable CO-Oximeter Sensor Systems, or ReSposable Pulse Oximeter Sensor Systems only.) Replace the adhesive portion of the sensor. REPLACE REUSABLE The reusable sensor (i.e.
Alarms and Messages 5 MESSAGE POSSIBLE CAUSE(S) RECOMMENDATION LOW SIGNAL IQ Low signal quality. Ensure proper sensor application. Move sensor to a better perfused site. Refer to Section 4, Signal IQ. LOW SpCO SIQ SpCO measurement reading is obscured. Ensure proper sensor application. Check sensor to see if it is working properly. If not, replace the sensor. Refer to Section 4, Numeric Display - SpCO. LOW SpMet SIQ SpMet measurement reading is obscured. Ensure proper sensor application.
Alarms and Messages 5 3D ALARM Overview The Radical-7 Pulse CO-Oximeter includes user-selectable High and Low alarm limits for SpO2 and pulse rate to provide audible and visual indication of specific levels of these vital signs that the clinician has determined merits their attention as described in Section 5 of this manual. The 3D ALARM enables clinicians to be alerted to changes in multiple interacting factors to provide an additional level of vigilance and flexibility to manage their patients.
5 Alarms and Messages Desat Index Alarm Traditional high and low SpO2 alarm limits alert clinicians to saturation levels that exceed userselected thresholds, and these thresholds are typically established at a considerable change from the patients’ baseline saturation level.
Alarms and Messages 5 USER INTERACTION TO IMPLEMENT DESAT INDEX ALARM The Desat Index Alarm function is enabled in the Radical-7 by the following method: 1. Select the 3D ALARM menu from the main menu page. 2. Select Desat Index. 3.
5 Alarms and Messages Perfusion Index (PI) Delta Alarm Perfusion Index gives an indication of the level of perfusion at the monitored site. The Radical-7 measures perfusion at the SpO2 site by comparing the pulsatile signal to the non-pulsatile signal, and expressing that ratio as a percentage.
Alarms and Messages 5 USER INTERACTION TO IMPLEMENT PI DELTA ALARM (CONTINUED) If the PI Delta measurement is greater (more negative) than the configured PI Delta Alarm, then the Radical-7 will make a MEDIUM priority alarm tone, and post an alarm message as follows: PI DELTA = ##% where ## is equal to the current PI Delta percentage and updates real time. The PI trend graph will also display.
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6 Troubleshooting Troubleshooting The following chart describes what to do if the Radical-7 Pulse CO-Oximeter system does not operate properly or fails. PROBLEM POSSIBLE CAUSE(S) INSTRUMENT DOES NOT POWER ON One or both of the fuses are not operating properly. INSTRUMENT POWERS ON BUT THE GRAPHIC DISPLAY IS BLANK The viewing contrast is not correct. CONTINUOUS SPEAKER Internal failure. TONE BUTTONS DON’T WORK WHEN PRESSED Internal failure. RECOMMENDATION Replace the fuses.
6 Troubleshooting Troubleshooting (continued) PROBLEM POSSIBLE CAUSE(S) Improper sensor type or application. Excessive motion relative to perfusion. Sensor is damaged or not functioning. LOW SIGNAL QUALITY SpO2 VALUES DO NOT CORRELATE WITH CLINICAL ASSESSMENT OR ABGs PULSE SEARCH MESSAGE UNEXPECTED SpO2, SpCO, SpMet OR SpHb READING UNEXPECTEDLY HIGH SpCO READING RECOMMENDATION Check and see if blood flow to the site is restricted. Check the placement of the sensor.
Troubleshooting 6 Troubleshooting (continued) PROBLEM PRINT FUNCTION DOES NOT WORK LED LIGHTS ON LEFT SIDE OF DOCKING STATION CONTINUOUSLY FLASH BATTERY RUN-TIME IS SIGNIFICANTLY REDUCED POSSIBLE CAUSE(S) RECOMMENDATION Make sure a null modem cable is Wrong serial cable is used used. Incompatible version of Upgrade to current software versions. software on Radical-7 Match handheld to docking station handheld and docking with compatible software versions station. Battery Memory effects.
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7 Specifications Radical-7 Specifications PERFORMANCE Measurement Range SpO2: 0 -100% SpMet: 0 - 99.9% SpCO: SpHb SpOC Pulse Rate: Perfusion Index: Pleth Variability Index: 0 - 99% 0 - 25 g/dl 0 - 35 ml of O2/dl of blood 25 - 240 (bpm) 0.
7 Specifications Radical-7 Specifications (continued) ELECTRICAL Standalone AC Power requirements: Power consumption: Fuses: 100-240 VAC, 47-63 Hz 55 VA 1 Amp, Fast Acting, Metric, (5x20mm), 250V Batteries Handheld: Type: Capacity: Charging time: Docking Station (RDS-1B): Type: Capacity: Charging time: NiMH 4 hours7 3 hours NiMH 10 hours7 6 hours ENVIRONMENTAL Operating Temperature: Transport/Storage Temperature: 41°F to 104°F (5°C to 40°C) -40°F to 158°F (-40°C to +70°C)8 Operating Humidity: 5% to
7 Specifications Radical-7 Specifications (continued) Sensor condition, system failure and low battery alarms High Priority: 571 Hz tone, 5 pulse burst, pulse spacing: 0.250s, 0.250s, 0.500s, 0.250s, repeat time:10s Medium Priority: 550 Hz tone, 3 pulse burst, pulse spacing: 0.375s, 0.375s, repeat time: 7s Low Priority: 500 Hz tone, 1 pulse burst, repeat time: 5s Alarm Muted reminder: 500Hz tone, 2 pulse burst, pulse spacing 0.375s, repeat time: 3min.
7 Specifications Radical-7 Specifications (continued) 4 The Radical-7 has been validated for low perfusion accuracy in bench-top testing against a Biotek Index 2TM* simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70-100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
7 Specifications SERIAL INTERFACE SETUP (CONTINUED) The pin-outs for the RS-232 connector are shown in the following table: PIN SIGNAL NAME 1 No Connection 2 Receive data – RS-232 ±9 V (±5 Vmin) 3 Transmit data – RS-232 ±9 V (±5 Vmin) 4 No Connection 5 Signal Ground Reference for COM signals 6 No Connection 7 No Connection 8 No Connection 9 No Connection SERIAL PRINTER SETUP To print the SpO2 and pulse rate data in ASCII 1 format on a serial printer, simply connect the serial printer t
7 Specifications PIN SIGNAL NAME 7 Nurse Call (Normally Closed) 8 Ground 9 Analog 1 10 Ground 11 Ground 12 Nurse Call – Common 13 Ground 14 Ground 15 Analog 2 ANALOG OUTPUT The Radical-7 Pulse CO-Oximeter can interface with various analog recording instruments and/or strip chart recorders through its Analog Output connector located on the back of the Docking Station.
7 Specifications The nurse call relays have the following electrical specifications per switch: PARAMETER SPECIFICATION MAX VOLTAGE 100VDC or AC peak MAX CURRENT 100mA WARNING: THE NURSE CALL FEATURE IS DISABLED WHEN THE AUDIBLE ALARMS ARE SILENCED WHILE THE NURSE CALL SETTING IN THE OUTPUT MENU IS SET TO “ALARMS”.
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Sensors & Patient Cables 8 Introduction This section covers the use and cleaning of Masimo sensors and patient cables. Before use of any sensor, carefully read the sensor’s Directions for Use. Use only Masimo sensors and cables with the Radical-7 Pulse CO-Oximeter. Other transducers, sensors and cables may affect the Radical-7 Pulse CO-Oximeter performance. Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly.
8 Masimo Sensors The following sensors are compatible for use with the Radical-7 Pulse CO-Oximeter. See the sensor directions for use for full sensor specifications, including accuracy. MASIMO RAINBOW SENSORS Masimo Rainbow sensors must be used for the Radical-7 Pulse CO-Oximeter parameters to enable measurement of Oxyhemoglobin (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet) and Total Hemoglobin (SpHb).
8 Masimo Sensors (continued) MASIMO SPO2 SENSORS The Radical-7 may use standard Masimo LNOP, LNOPv and LNCS SpO2 sensors, when used with Red PC or Red LNC Patient Cables respectively. Select the appropriate patient cable to attach the LNOP or LNCS sensor to the instrument. ReSposable™ Pulse CO-Oximeter Sensor System The Rainbow ReSposable Sensors are used as a system.
8 Masimo Sensors (continued) LNOP® Specialty Sensors LNOP sensors must be used in conjunction with Red PC cables. • • • • Newborn Infant/Pediatric Newborn Neonatal Trauma Blue M-LNCS™/LNCS® Reusable Sensors LNCS sensors must be used in conjunction with LNC cables. • • • • • DCI DCIP YI TC-I TF-I M-LNCS™/LNCS® Adhesive Sensors LNCS sensors must be used in conjunction with Red LNC cables.
8 Masimo Sensors (continued) REATTACHMENT OF SINGLE USE ADHESIVE SENSORS Single use sensors may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin. NOTE: If the sensor fails to track the pulse consistently, the sensors may be incorrectly positioned. Reposition the sensor or choose a different monitoring site.
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Service / Maintenance 9 Introduction This section covers: ■ How to test the operation of the Radical-7 Pulse CO-Oximeter and the SatShare interface. ■ How to properly clean the Radical-7 Pulse CO-Oximeter. ■ How to recharge and replace the batteries. ■ How to replace the fuses. ■ How to obtain service. Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only.
9 Service / Maintenance Battery Operation and Maintenance The Radical-7 Pulse CO-Oximeter Handheld includes a 1.5 Amp-Hour Nickel Metal Hydride battery. The Radical-7 Pulse CO-Oximeter Docking Station may include the optional 6.5 AmpHour Nickel Metal Hydride battery. Before using the Radical-7 Pulse CO-Oximeter as a Handheld or transport monitor, the Handheld battery and the optional Docking Station battery need to be fully charged.
9 Service / Maintenance Battery Operation and Maintenance (continued) The following tables outline the estimated run times of the battery powered Radical-7 Pulse CO-Oximeter. The time estimates are based on a Radical-7 Pulse CO-Oximeter with fully charged batteries. The time estimates are also based on a Radical-7 with and without the backlight lit, and the power save feature enabled and disabled. The Radical-7 Pulse CO-Oximeter is always configured to include the Handheld battery.
9 Service / Maintenance REPLACING THE BATTERIES Before installing or removing the battery, make sure the AC power cord is removed and power to the Pulse CO-Oximeter is turned off. To replace the Handheld battery, follow these instructions: 1. Turn the Radical-7 Pulse CO-Oximeter Handheld off and remove the patient cable connection. Detach the Radical-7 Pulse CO-Oximeter Handheld from the Docking Station (if docked). 2. Loosen the closure screw on the battery compartment door and lift out the battery. 3.
Service / Maintenance 9 Performance Verification To test the performance of the Radical-7 Pulse CO-Oximeter following repairs or during routine maintenance, follow the procedure outlined in this section. If the Radical-7 Pulse CO-Oximeter fails any of the described tests, discontinue its use and correct the problem before returning the instrument back to the user.
9 Service / Maintenance Testing with Masimo SET Tester (Optional): 1. 2. Turn the Radical-7 off and then on again. Connect the Masimo SET Tester to the Pulse CO-Oximeter Patient Cable Connector. Refer to the Masimo SET Tester's Directions for Use for further instructions. Nurse Call Test: 1. 2. 3. Disconnect the Red patient cable or the Masimo SET Tester from the Radical-7 and turn the instrument on. Ensure that there are no audible alarms and that the audible alarms are not silenced.
9 Service / Maintenance Service and Repair REPAIR POLICY Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the instrument repaired. WARNING: DO NOT REMOVE THE COVER OF THE MONITOR EXCEPT FOR BATTERY REPLACEMENT. AN OPERATOR MAY ONLY PERFORM MAINTENANCE PROCEDURES SPECIFICALLY DESCRIBED IN THIS MANUAL. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL TRAINED IN THE REPAIR OF THIS EQUIPMENT.
9 Service / Maintenance Warranty Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: (i) each new Product and the Software media as delivered are free from defects in workmanship or materials, and (ii) the Product and Software will perform substantially as labeled in the directions for use. Masimo’s sole obligation under this warranty is to repair or replace any Product or Software that is covered under warranty. Batteries are warranted for six (6) months.
Service / Maintenance 9 Sales & End-User License Agreement THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU (“PURCHASER”) AND MASIMO CORPORATION (“MASIMO”) FOR THE PURCHASE OF THIS PRODUCT (“PRODUCT”) AND A LICENSE IN THE INCLUDED OR EMBEDDED SOFTWARE (“SOFTWARE”). EXCEPT AS OTHERWISE EXPRESSLY AGREED IN A SEPARATE CONTRACT FOR THE ACQUISITION OF THIS PRODUCT, THE FOLLOWING TERMS ARE THE ENTIRE AGREEMENT BETWEEN THE PARTIES REGARDING YOUR PURCHASE OF THIS PRODUCT.
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Accessories PART NUMBER 10 DESCRIPTION 2386 REPLACEMENT BATTERY, RADICAL-7 HANDHELD 1317 RADICAL-7 POLE CLAMP 2350 RADICAL-7 HANDHELD LOCK 2351 RADICAL-7 HANDHELD LOCK KEY 2368 MASIMO SET TESTER - 20 PIN 1584 RADICAL-7 POWER CORD LOCK, 5/PACK 1908 TRENDCOM SOFTWARE 1595 SATSHARE CABLE, AT01 1324 SATSHARE CABLE, DO01 1326 SATSHARE CABLE, DO02 1528 SATSHARE CABLE, DO03 1533 SATSHARE CABLE, DO04 2023 SATSHARE CABLE, DO05 1325 SATSHARE CABLE, DS01 1539 SATSHARE CABLE, DS02 1528
Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo. 32218/4742F-0410 www.masimo.
