Pulse CO-Oximeter with Rainbow Technology OPERATOR’S MANUAL
The Radical-7R Pulse CO-Oximeter Operating Instructions provide the necessary information for proper operation of all models of the Radical-7R 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-7R 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) possibility of patient entanglement or strangulation. ■ Use cables only from the instrument manufacturer to provide protection against the effects of discharge from a cardiac defibrillator and burns. ■ Do not place the Pulse CO-Oximeter or accessories in any position that might cause it to fall on the patient. Do not lift the Pulse CO-Oximeter by the power cord or any other cable.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ Additional information specific to Masimo sensors, including information about parameter/ measurement performance during motion and low perfusion, may be found in the sensor's Directions for Use (DFU). ■ Do not place the Pulse CO-Oximeter where the controls can be changed by the patient. ■ Do not place the Pulse CO-Oximeter on electrical equipment that may affect the Pulse CO-Oximeter, preventing it from working properly.
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 Successful Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Masimo Pulse CO-Oximetry Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Numeric Display - SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Numeric Display - Pulse Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents SECTION 8 - SENSORS & PATIENT CABLES Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Selecting a Masimo SET Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Sensor Application Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Masimo Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview 1 About This Manual This manual explains how to set up and use the Radical-7R 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-7R Pulse CO-Oximeter is a noninvasive, arterial oxygen saturation, total hemoglobin concentration and pulse rate monitor. It can be used as either a Handheld or a Standalone monitor. The Radical-7R Pulse CO-Oximeter features a backlit Liquid Crystal Display (LCD) that continuously displays numeric values for SpO2, SpMet®*, SpCO®*, SpHb®*, SpOC™*, SpHct™, respiration rate (RRa™), pulse rate, Perfusion Index (PI) and Pleth Variability Index (PVI®).
1 Overview INDICATIONS FOR USE The Radical-7R Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).
1 Overview of pulse oximetry (spectrophotometry) to make its SpMet measurement. The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or 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.
1 1 Overview the hemoglobin concentration in g/dL times three and dropping the units1,2. The hematocrit measurement is determined mathematically in this monitor as: %Hct = Hb* g/dL x 2.953 * When Hb concentrations are between 8-17 g/dL. 1 Nijboer JMM, van der Horst ICC, Hendriks HGD, Hendrik-Jan ten Duis; Mijsten MWN. Myth or Reality: Hematocrit and Hemoglobin Differ in Trauma. Journal of TRAUMA Injury, Infection, and Critical Care 2007; 62:1310-1312 2 MS, Weatherall; KM Sherry.
Overview 1 SpHb measurements rely on a multiwavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin and the concentration of total hemoglobin in arterial blood. In an ambient temperature of 35º C the maximum skin surface temperature has been measured at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure.
Overview 1 SPCO, SPMET, AND SPHB MEASUREMENTS DURING PATIENT MOTION The Radical-7R 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.
Overview 1 Acquisition System The acquisition system converts the electrical signal provided by the sensor into a digital signal. This format allows the signal to be processed by a computing device. Signal Processing The digital signal produced by the acquisition system is converted into a measurement that corresponds to the respiratory parameter of interest.
1 Overview MASIMO RAINBOW SET PARALLEL ENGINES This figure is for conceptual purposes only.
System Description 2 Introduction The Radical-7R provides the functionality of three instruments in one: ■ The Radical-7R is a fully featured Handheld Pulse CO-Oximeter. ■ The Radical-7R is a fully featured Standalone Pulse CO-Oximeter. ■ The Radical-7R 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-7R contains the majority of the Pulse CO-Oximeter features.
2 System Description Radical-7R Pulse CO-Oximeter Handheld The Handheld Radical-7R 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-7R 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 96 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) 11 17.0 10.5 The SpHb Alarm Limits Display shows the upper and lower alarm limits. SpHb ALARM When the measured value is outside of the alarm limits, the SpHb LIMITS DISPLAY measurement display flashes and an alarm will sound. 12 TOUCH KEY CONTROL BUTTONS Press a Touch Key Control Button to select the corresponding touch key icon. See Section 4, Touch Key Control Buttons and Icons for more details. 13 RESERVED Reserved for future use.
System Description 2 HANDHELD FRONT PANEL (CONTINUED) 22 SIGNAL IQ The Signal IQ shows the acquired signal quality and the timing of the pulse. 23 8 PERFUSION INDEX The Perfusion Index indicates numerically the percentage of pulsatile signal to non-pulsatile signal (pulse strength). 24 APOD SENSITIVITY The sensitivity icon is shown on the Radical-7R display to indicate if the Radical 7R is set to operate in Normal, Maximum (MAX) or Adapative Probe Off Detection (APOD) mode.
System Description 2 HANDHELD FRONT PANEL (CONTINUED) 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 2-6 2 3 1 DOCKING STATION CONNECTOR The Radical-7R Handheld interfaces with the Docking Station through this connector. 2 POLE CLAMP ACCESSORY HOLDER The optional Pole Clamp accessory attaches to this holder.
System Description 2 Radical-7R Pulse CO-Oximeter Standalone When the Radical-7R Pulse CO-Oximeter Handheld is placed into the Docking Station, the Radical-7R Pulse CO-Oximeter becomes a full-featured standalone instrument. The Radical-7R 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-7R Standalone instrument. 10.0 17 7 SpHb g/dl a a ----- ----- 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.
System Description 2 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-7R 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 may be found on the Radical-7R 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.
System Description 2 Radical-7R Monitor Interface In addition to being a full-featured Handheld and Standalone Pulse CO-Oximeter, the Radical-7R Pulse CO-Oximeter’s unique SatShare interface links the Radical-7R 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-7R 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-7R 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.
Setup 3 SatShare Setup The Radical-7R Pulse CO-Oximeter has been proven to be accurate during patient motion and low perfusion conditions. Saturation and pulse rate values from the Radical-7R 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.
Setup 3 7. While in the SatShare mode, if there are any significant discrepancies between the readings from the Radical-7R Pulse CO-Oximeter and those on the monitor displaying the values obtained from SatShare, the values reported by the Radical7R Pulse CO-Oximeter are to be considered the correct values. 8. To use the Radical-7R Pulse CO-Oximeter with SatShare while it is not connected to AC power, set the Power Save parameter in the General menu to “No” and refer to Section 4 Operation.
Setup 3 THE RADICAL-7R 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 RADICAL7R PROVIDES AUDIBLE ALARMS FOR SpO2 AND PULSE RATE WHEN THE CONNECTION TO THE INTERFACED SYSTEM BECOMES COMPROMISED.
Operation 4 Introduction To operate the Radical-7R 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) Parameter/Measurement SpO2, PI, Pulse Rate SpCO, SpMet SpHb PVI RRa Approximate Time (in seconds) until Number Stabilization 15 seconds 25 seconds 90 seconds 90 seconds 60 seconds 10. Verify that the patient alarms are functional by setting the high and low SpO2, SpMet, SpCO, SpHb, PI, PVI, pulse rate and respiration rate alarm limits beyond the patient readings. An alarm tone sounds. The violated alarm limit and reading flash on the display.
Operation 4 NOTE: When a Masimo Rainbow Sensor is properly connected to the patient, the instrument normally goes through a 20-30 second sensor calibration/pulse search routine and then displays numeric values installed on the instrument and supported by the sensor. It also provides graphical displays for plethysmographic waveform, Signal Identification and Quality Indicator (Signal IQ®).
4 Operation NUMERIC DISPLAY - SpO2 Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is a relative term, experience will provide confidence in changes that are artifactual or physiological and the speed, timing, and behavior of each. The stability of the readings over time is affected by the averaging mode being used. The longer the averaging time, the more stable the readings tend to become.
Operation 4 caused by fluctuations in the oxygen saturation, blood concentration and perfusion. Inaccurate measurements may be caused by: ■ ■ ■ ■ ■ Intravascular dyes such as indocyanine green or methylene blue. Low arterial perfusion. Low arterial oxygen saturation levels. Elevated Total Bilirubin levels. Motion artifact.
4 Operation SIGNAL INDICATION AND QUALITY INDICATOR (SIQ) The Radical-7R 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-7R 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 SIGNAL INDICATION AND QUALITY INDICATOR - ACOUSTIC (SIQa) SIQa displays the confidence level of the measured signal. A high confidence level displays as a high percentage. When the SIQa is high and the parameter label flashes, there may be interference from excessive ambient or environmental noise. A low confidence level displays as a low percentage. A very small signal, with a red bar, may indicate that the acuracy of the respiration rate measurement may be compromised.
4 Operation NUMERIC DISPLAY - (PI) The perfusion index (PI) display provides a relative numeric indication of the pulse strength at the monitoring site. It is a calculated percentage of the pulsatile signal to non-pulsatile signal of arterial blood moving through the site. PI may be used to find the best perfused site and to monitor physiological changes in the patient. It displays an operating range of 0.01 percent to 20.00 percent. A percentage greater than 1.00 percent is desired.
Operation 4 significant immunity to ambient or strobing light, excessive ambient or excessive strobing light may cause readings to be incorrect. CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE PATIENT’S VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE CO-OXIMETER FOR PROPER FUNCTIONING. SENSITIVITY Three sensitivity levels enable a clinician to tailor the response of the Radical-7R to the needs of the particular patient situation.
4 Operation Touch Key Control Buttons and Icons On the Radical-7R Pulse CO-Oximeter display, four icons are shown on the right side of the LCD display. These icons can be selected either by using the touch key control buttons or the touchscreen. The touch key control buttons are the four dark grey control buttons to the right of the Handheld display. To select an icon, press and release the touch key control button to the right of the icon, or touch it on the touchscreen.
4 Operation 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 MAIN MENU ALARM LIMITS MENU 4-12 Radical-7R Pulse CO-Oximeter Operator’s Manual
Operation 4 GENERAL MENU ABOUT MENU CONFIGURATION MENU Radical-7R Pulse CO-Oximeter Operator’s Manual 4-13
Operation 4 AVERAGING MENU OUTPUT MENU FACTORY DEFAULTS MENU 4-14 Radical-7R Pulse CO-Oximeter Operator’s Manual
Operation 4 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.
Operation 4 MENU ITEMS PI HIGH LIMIT PI LOW LIMIT PVI HIGH LIMIT PVI LOW LIMIT RRa HIGH LIMIT RRa LOW LIMIT DELAY 4-16 DESCRIPTION The PI high alarm limit can be set anywhere between 0.04 and 19, then “---” with a 0.01 step size between 0.04 and 0.10, a 0.10 step size between 0.10 and 1.0, and a 1.0 step size between 1.0 and 19. In the “---” (off) setting, the PI High Alarm Limit Alarm is disabled.
Operation 4 General MENU ITEMS DESCRIPTION FASTSAT Select Yes to activate the FastSat algorithm. In the 2 and 4 seconds averaging mode, the FastSat algorithm is automatically enabled. SMART TONE Select Yes to activate the SmartTone function. This will allow the audible pulse to continue to beep when the pleth graph shows signs of motion. Select NO to turn off SmartTone. PULSE TONE Select YES to activate the Pulse Tone function.
Operation 4 Output NOTE: The output menu selections are only available when the Radical -7 Handheld is interfaced to the Docking Station. MENU ITEMS DESCRIPTION ALARMS The nurse call output will be activated based on alarm events. LOW SIGNAL IQ NURSE CALL The nurse call output will be activated based on Low Signal IQ events. ALARM & SIGNAL IQ The nurse call ouput will be activated based on alarm and Low Signal IQ events. NORMAL Standard polarity. See Section 7, Nurse Call specifications.
Operation 4 SatShare Operation When the SatShare cable is connected to the Radical-7R Pulse CO-Oximeter and to a multiparameter patient monitor, the Radical-7R Pulse CO-Oximeter automatically starts to operate in the SatShare mode. In the SatShare mode, Radical-7R Pulse CO-Oximeter operates as follows: ■ All visual alarms remain active. ■ All audible alarms may be disabled by software configuration of the Radical-7R Pulse CO-Oximeter. Refer to Section 4, Alarms.
Operation 4 SatShare Operation (continued) ■ While operating in the SatShare mode, the Radical-7R Pulse CO-Oximeter may automatically disable the SatShare interface if the perfusion index drops below 0.1% while the sensitivity is set to Max sensitivity.
Alarms and Messages 5 Alarm Identification The Radical-7R 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 POSSIBLE CAUSE RECOMMENDATION REPLACE SENSOR SpHb reusable sensor has used all of its available monitoring time. Replace sensor. Sensor is non-functional.
Alarms and Messages 5 System Messages (continued) MESSAGE REPLACE ADHESIVE POSSIBLE CAUSE RECOMMENDATION 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 sen- Replace the adhesive portion of sor has expired. (Applies to Rainbow the sensor. ReSposable CO-Oximeter Sensor Systems, or ReSposable Pulse Oximeter Sensor Systems only) LOW BATTERY Battery charge is low.
5 Alarms and Messages System Messages (continued) 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.
Alarms and Messages 5 System Messages (continued) MESSAGE POSSIBLE CAUSE(S) RECOMMENDATION INCOMPATIBLE AC CABLE Not a compatible cable. Replace with a proper cable. Refer to Section 8. REPLACE AC CABLE Pulse CO-Oximeter cannot identify the connected cable or the cable has failed. Inoperative or faulty cable; Replace cable. Refer to the Directions for Use of the cable being used. REPLACE AC CABLE Not a proper AC cable. Replace with proper AC cable. Refer to Section 8.
Troubleshooting 6 Troubleshooting The following chart describes what to do if the Radical-7R Pulse CO-Oximeter system does not operate properly or fails. PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION INSTRUMENT DOES NOT POWER ON One or both of the fuses are not operating properly. Replace the fuses. INSTRUMENT POWERS ON BUT THE GRAPHIC DISPLAY IS BLANK The viewing contrast is not correct. Instrument requires service. CONTINUOUS SPEAKER TONE Internal failure. Instrument requires service.
Troubleshooting 6 Troubleshooting (continued) PROBLEM LOW SIGNAL QUALITY SpO2 VALUES DO NOT CORRELATE WITH CLINICAL ASSESSMENT OR ABGs PULSE SEARCH MESSAGE UNEXPECTED SpO2, SpCO, SpMet OR SpHb READING POSSIBLE CAUSE(S) Improper sensor type or application. Excessive motion relative to perfusion. Sensor is damaged or not functioning. RECOMMENDATION Check and see if blood flow to the site is restricted. Check the placement of the sensor. Re-apply sensor or move to a different site.
Troubleshooting 6 Troubleshooting (continued) PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION Insert handheld into docking station, verify Low battery/ not plugged docking station power cord plugged in into AC power supply. and docking station power indicator light is illuminated. Interference from line- Verify/set 50/60hz menu setting. Refer to frequency induced noise. Section 3, Initial Setup for details.
7 Specifications Radical-7R specifications PERFORMANCE Measurement Range SpO2: 0 -100% SpMet: 0 - 99.9% SpCO: 0 - 99% SpHb SpOC 0 - 25 g/dl 0 - 35 ml of O2/dl of blood SpHct Pulse Rate: RRa (Respiration Rate) SIQa 0 - 75% 25 - 240 (bpm) 0-70 breaths per minute 0-100% Perfusion Index: Pleth Variability Index: 0.
7 Specifications Radical-7R specifications (continued) Arterial Oxygen Saturation (%SpO2) Carboxyhemoglobin Saturation (%SpCO) Methemoglobin Saturation (%SpMet) Total Hemoglobin (SpHb g/dl) Respiration Rate (RRa) Pulse Rate (bpm) 1% 1% 0 .1% 0.
7 Specifications Radical-7R specifications (continued) Audible and visual alarms for high low saturation and pulse rate (SpO2 range 1% - 99%, SpCO range 1% - 98%, SpMet range 1% - 99.5%, SpHb range1 g/dl - 24.5 g/dl, RRa range 4 - 70 breaths per minute, PI range 0.03% - 19%, PVI range 1% - 99%, pulse rate range 30 - 235 BPM) 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.
7 Specifications Radical-7R specifications (continued) of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
7 Specifications ANALOG OUTPUT The Radical-7R Pulse CO-Oximeter can interface with various analog recording devices and/or strip chart recorders through its Analog Output connector located on the back of the Docking Station. Depending on the configuration of the Output menu, the following parameters are output continuously on the Analog 1 and Analog 2 channels: ■ SpO2 ■ Pulse rate ■ Plethysmographic waveform ■ Signal IQ The output signals vary from approximately 0 to 1 volt in a linear fashion.
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-7R Pulse CO-Oximeter. Other transducers, sensors and cables may affect the Radical-7R 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 Sensors & Patient Cables Masimo Sensors The following sensors are compatible for use with the Radical-7R Pulse CO-Oximeter. See the sensor directions for use for full sensor specifications, including accuracy. MASIMO ACOUSTIC RESPIRATION SENSOR The Acoustic Respiration sensor must be used with the Radical-7R Pulse CO-Oximeter to enable monitoring of respiration rate (RRa).
Sensors & Patient Cables 8 Masimo Sensors continued Rainbow Direct Connect Sensors Rainbow Direct Connect sensors connect to the instrument directly. • DCI-dc3 • DCI-dc8 • DCI-dc12 • DCIP-dc3 • DCIP-dc8 • DCIP-dc12 • DC-3 SC360 • DC-12 SC360 • DCP-3 SC360 • DCP-12 SC360 • DC-3 SC200 • DCP-3 SC200 MASIMO SPO2 SENSORS The Radical-7R may use standard Masimo LNOP, LNOPv and LNCS SpO2 sensors, when used with Red PC or Red LNC Patient Cables respectively.
8 Sensors & Patient Cables • DCP-3 • DCP-12 Masimo Sensors continued LNOP® Reusable Sensors LNOP sensors must be used in conjunction with Red PC cables. • DCI • DCIP • YI • TC-I • DC-195 • TF-I LNOP® Adhesive Sensors LNOP sensors must be used in conjunction with Red PC cables. • Adt/Adtx • Pdt/Pdtx • Inf • Neo • NeoPt TM LNOPv Adhesive Sensors LNOPv sensors must be used in conjunction with Red PC cables. • In • Ne • Ad LNOP® Specialty Sensors LNOP sensors must be used in conjunction with Red PC cables.
Sensors & Patient Cables 8 • TC-I • TF-I Masimo Sensors continued M-LNCS™/LNCS® Adhesive Sensors LNCS sensors must be used in conjunction with Red LNC cables. • Adtx • Pdtx • Inf • Neo • NeoPt • NeoPt-500 M-LNCS™/LNCS® Specialty Sensors LNCS specialty sensors must be used in conjunction with Red LNC cables.
8 Sensors & Patient Cables • Newborn Neonatal • Trauma Masimo Sensors continued SENSOR ACCURACY See Sensor Directions for Use (DFU) for sensor accuracy specifications for: SpO2, SpMet, SpCO, SpHb, pulse rate and respiration rate. CLEANING AND REUSE OF MASIMO REUSABLE SENSORS AND CABLES Reusable sensors and patient cables can be cleaned per the following procedure: 1. Remove the sensor from the patient. 2. Disconnect the sensor from the patient cable. 3. Disconnect the patient cable from the monitor.
Service / Maintenance 9 Introduction This section covers: ■ How to properly clean the Radical-7R 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. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations.
9 Service / Maintenance Battery Operation and Maintenance The Radical-7R Pulse CO-Oximeter Handheld includes a 1.5 Amp-Hour Nickel Metal Hydride battery. The Radical-7R Pulse CO-Oximeter Docking Station may include the optional 6.5 AmpHour Nickel Metal Hydride battery. Before using the Radical-7R 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) CONFIGURATION #1: Radical-7R Pulse CO-Oximeter configured to only include the Handheld battery (standard configuration); the Docking Station battery is excluded. NOTE: For this configuration, it is advisable to operate only the Radical-7R Handheld instrument when running on battery power.
9 Service / Maintenance To replace the fuse(s), you will need a flat-blade screwdriver (5mm; 3/16”). To replace the fuses: 1. 2. 3. 4. 5. 6. 7. 8. 9. Disconnect instrument from AC power. Remove AC power cord from the power entry module at the rear of the docking station. Use the small flat-blade screwdriver and gently pry loose the fuse cover in the left portion of the power entry module, exposing the fuse holder. Using the small flat-blade screwdriver, gently remove the fuse holder.
Service / Maintenance 1. 2. 3. 4. With the monitor turned on, select the Menu Access key and enter the Alarm menu. Change the High SpO2 Alarm parameter to a value two points below the currently selected value, and accept the change. Verify that the newly set parameter is shown on the Saturation Alarm Limit Display, next to the SpO2 or pulse rate measurement display. Return the High Saturation Alarm parameter to its original setting.
Service / Maintenance 9 6. Connect a patient cable and sensor and verify that the voltage on pins 9 and 15 are between 0V and 1.0V while measuring a saturation and pulse rate. Battery Test: 1. 2. 3. Fully charge the Radical-7R by placing the Handheld into the Docking Station and connecting the AC power. Verify that the green Handheld Battery Indicator LED is illuminated. When the Radical-7R is fully charged the green Handheld Battery Indicator turns off. 4.
Service / Maintenance 9 Return Radical-7R Pulse CO-Oximeter to the following shipping address: For USA, Canada & Asia Pacific: For Europe: All other locations: Masimo Corporation 40 Parker Irvine, California 92618 949-297-7000 FAX 949-297-7001 Masimo International Sàrl Puits-Godet 10 2000 Neuchatel SWITZERLAND Tel: +41 32 720 1111 Fax.: +41 32 724 1448 Contact your local Masimo Representative.
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.
Service / Maintenance 9 End-User License Agreement 1. Grant of License: In consideration of payment of the Software license fee, which is part of the price paid for the Product, Masimo grants to Purchaser a nonexclusive, nontransferable (except as set forth below) license (“License”), without right to sublicense, to use the copy of the Software in connection with Purchaser’s use of the Product for its labeled purpose as set forth in these directions for use.
9 Service / Maintenance Sensors Licensed for Monitoring Use Only Sensors designated for monitoring only are licensed to you under patents owned by Masimo to be used for patient monitoring, in an unmodified form as originally received from Masimo, and no license is granted to have Masimo’s sensors reprocessed or otherwise modified, unless specifically authorized by Masimo. There is no license, implied or otherwise, that would allow use of licensed sensors beyond their intended duration.
Part Numbers PART NUMBER 10 DESCRIPTION 2386 REPLACEMENT BATTERY, RADICAL-7R HANDHELD 1317 RADICAL-7R POLE CLAMP 2350 RADICAL-7R HANDHELD LOCK 2351 RADICAL-7R HANDHELD LOCK KEY 2368 MASIMO SET TESTER - 20 PIN 1584 RADICAL-7R POWER CORD LOCK, 5/PACK Please visit our website, www.masimo.com, for updated information about Masimo products.
Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo. 33975/6189A-1209 www.masimo.
