Page 1
Pulse CO-Oximeter with Rainbow Technology OPERATOR’S MANUAL...
Page 2
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.
Page 3
Variation in hemoglobin measurements may be profound and may be affected by sample type, body positioning, as well as other physiological conditions. As with most hemoglobin tests, Radical-7R test results should be scrutinized in light of a specific patient’s condition. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data.
Page 4
■ Always remove the sensor from the patient and completely disconnect the patient from the Pulse CO-Oximeter before bathing the patient. Radical-7R Pulse CO-Oximeter Operator’s Manual...
Page 5
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ Additional information specifi c 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.
A b o u t T h i s M a n u a l 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.
Sample of Caution: CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A NOTE is provided when extra general information is applicable. Sample of Note: NOTE: This is a sample of a Note. Radical-7R Pulse CO-Oximeter Operator’s Manual...
Pleth Variability Index (PVI ® ). It also provides graphical displays for plethysmographic waveform and Signal Identifi cation and Quality Indicator (Signal IQ ® ). The Radical-7R Pulse CO-Oximeter can be used to interface with a multiparameter patient monitor to provide Masimo SET SpO 2 and pulse rate information to that monitor for display.
O v e r v i e w 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).
Hematocrit is the fraction of whole blood volume that consists of red blood cells. In nor- mal conditions, there is a linear relationship between hematocrit and the concentration of hemoglobin. An estimated hematocrit as a percentage may be derived by multiplying Radical-7R Pulse CO-Oximeter Operator’s Manual...
(7 + wavelengths) 2. Detector Once the Radical-7R receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology to calculate the patient’s functional oxygen saturation (SpO 2 (%)), blood levels of carboxyhemoglobin (SpCO (%)), methemoglobin (SpMet (%)), Total Hemoglobin concentration (SpHb (g/dl)) and pulse rate (PR (BPM)).
In an ambient temperature of 35º C the maximum skin surface temperature has been measured at less than 106º F (41º C), verifi ed by Masimo sensor skin temperature test procedure.
O v e r v i e w 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...
Page 17
[5] Gavriely N, Cugell DW. Airflow effects on amplitude and spectral content of normal breath sounds. J Appl Physiol 1996; 80: 5-13. [6] Gavrieli N, Palti Y, Alroy G. Spectral characteristics of normal breath sounds. J Appl Physiol 1981; 50: 307-314. Radical-7R Pulse CO-Oximeter Operator’s Manual...
O v e r v i e w MASIMO RAINBOW SET PARALLEL ENGINES This fi gure is for conceptual purposes only. SpOC ® MASIMO SET DST 1-10 Radical-7R Pulse CO-Oximeter Operator’s Manual...
■ The Radical-7R is a fully featured Standalone Pulse CO-Oximeter. ■ The Radical-7R interfaces to the SpO 2 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.
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.
Page 21
“Sensor Off” will appear at DISPLAY the top of the display screen. The display will show dashed lines during pulse search. The total hemoglobin is calculated and the display is updated at a frequency of once per second Radical-7R Pulse CO-Oximeter Operator’s Manual...
Page 22
Connect a patient cable or a direct cable sensor into the Handheld PATIENT CABLE Radical-7R by plugging the cable into the Patient Cable Connector. Use CONNECTOR only Masimo compatible sensors and cables with this Pulse CO-Oximeter.
Page 23
The Perfusion Index indicates numerically the percentage of INDEX pulsatile signal to non-pulsatile signal (pulse strength). 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 APOD SENSITIVITY Adapative Probe Off Detection (APOD) mode.
See the Directions for Use of the Pole Clamp accessory for ACCESSORY attachment instructions. HOLDER The Radical-7R Handheld is powered by a NiMH battery BATTERY PACK located in this compartment. For battery care and replacement please see Section 9, Replacing the Batteries.
R a d i c a l - 7 R P u l s e C O - O x i m e t e r S t a n d a l o n e 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.
S y s t e m D e s c r i p t i o n STANDALONE FRONT PANEL The following figure and corresponding text review the features of the Radical-7R Standalone instrument. 10.0 SpHb g/dl SpOC ml/dl DOCKING...
STANDALONE BACK PANEL 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 SERIAL OUTPUT CO-Oximeter. The data is provided in standard RS-232C CONNECTOR format.
S y s t e m D e s c r i p t i o n 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.
R a d i c a l - 7 R M o n i t o r I n t e r f a c e 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 SpO input connector.
S e t u p I n t r o d u c t i o n 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.
Place the Docking Station on a stable hard flat surface near the patient. Always place the Radical-7R Pulse CO-Oximeter instrument on a dry surface. Maintain a minimum of 3 cm (1 inch) free space around the Radical-7R Pulse CO-Oximeter Standalone instrument. Make sure that the Radical-7R speaker is not covered to avoid a muffled alarm sound.
S e t u p S a t S h a r e S e t u p 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.
Page 33
AC power, set the Power Save parameter in the General menu to “No” and refer to Section 4 Operation. Please note that if the Radical-7R Pulse CO-Oximeter is used in this mode, the length of time the Radical-7R Pulse CO-Oximeter can operate on battery power will be significantly diminished.
Page 34
S e t u p THE RADICAL-7R REVERTS TO INTERFACE ALARM SpO 2 /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- 7R PROVIDES AUDIBLE ALARMS FOR SpO 2 AND PULSE RATE WHEN THE CONNECTION TO THE INTERFACED SYSTEM BECOMES COMPROMISED.
NOTE: “- - -” initially shows in the numeric display fields for all the parameters/measurements when the Radical-7R is turned on. As the system starts monitoring, the numeric display fields update (refresh). The numeric display fields for the parameters/measurements begin to show numbers during the refresh cycles even though the numbers have not stabilized;...
Place the sensor on a site that has unrestricted blood flow. ■ Do not secure a sensor with tape. ■ Do not select a site near potential electrical interference (electrosurgical unit, for example). ■ Read the sensor Directions for Use for proper sensor application. Radical-7R Pulse CO-Oximeter Operator’s Manual...
■ Turn the power off and on at the instrument. If a Masimo Rainbow Adhesive Sensor is being used and “SpO2 Only Mode” appears on the display screen, perform one of the following steps to to obtain Rainbow values: ■...
Motion artifact. NUMERIC DISPLAY - PULSE RATE The Pulse Rate displayed on the Radical-7R Pulse CO-Oximeter may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with the signal quality due to physiological changes in the patient or one of the instruments or application of the sensor or patient cable.
When the SpHb signal quality is very low, the accuracy of the SpHb measurement may be compromised. A Low SpHb SIQ message is displayed in the message area on the Radical-7R Pulse CO-Oximeter display, and the parameter/measurement value will display dashes (“---”) instead of a number value for SpOC and SpHct.
■ Check the Acoustic Respiration sensor and ensure proper sensor application. The Acoustic Respiration sensor must be well secured to the site for the Radical-7R to maintain accurate readings. Refer to the Acoustic Respiration sensor's Directions for Use for proper sensor placement.
PVI is displayed as a percentage (0-100%). LOW PERFUSION The Radical-7R Pulse CO-Oximeter displays a “Low PI” message when there are very low amplitude arterial pulsations. It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation 3 .
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. They are as follows: ■...
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.
Select the Accept icon to save the changes. ACCEPT Select the Previous icon to increase or toggle the parameter/ PREVIOUS measurement settings. Select the Next icon to decrease or toggle the parameter/ NEXT measurement settings. Radical-7R Pulse CO-Oximeter Operator’s Manual 4-11...
NOTE: The low alarm limit must be set below the high alarm setting. If the high alarm limit is set below the low alarm limit, the low alarm limit will automatically adjust to the next setting below the newly entered high alarm limit setting. Radical-7R Pulse CO-Oximeter Operator’s Manual 4-15...
Page 50
This menu allows the users to set an audible saturation delay. The delay DELAY can be set to either 0, 5,10 or 15 seconds. The delay setting only affects saturation alarms indications. 4-16 Radical-7R Pulse CO-Oximeter Operator’s Manual...
NOTE: The hemorheologic profi le of arterial and venous blood samples can vary 1 . To accommodate this difference, the SpHb Cal Radical-7R provides the option of displaying a SpHb parameter that is based on either Arterial or Venous SpHb laboratory blood sample draw.
Closed contacts. See Section 7, Nurse Call specifi cations. CAUTION: TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY EQUIPMENT TO THE SERIAL PORT ON THE BACK PANEL UNLESS THE RADICAL-7R IS CONNECTED TO THE AC POWER FROM THE WALL OUTLET. 4-18...
S a t S h a r e O p e r a t i o n 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.
Page 54
SatShare interface if the perfusion index drops below 0.1% while the sensitivity is set to Max sensitivity. To enable the SatShare interface again, set the Radical-7R Pulse CO-Oximeter to the Normal or APOD sensitivity mode, increase the perfusion at the measurement site (by warming the patient or sensor site), or move the sensor to a site with better perfusion.
A l a r m I d e n t i f i c a t i o n 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.
Correct the correct adhesive por- REPLACE unrecognized. (Applies to Rainbow tion of the sensor. ADHESIVE ReSposable CO-Oximeter Sensor Systems, or ReSposable Pulse Oximeter Sensor Systems only) Radical-7R Pulse CO-Oximeter Operator’s Manual...
Page 57
"SpO 2 Only Mode" message for Use instructions, Section occurs during an unsucessful SPO 2 ONLY MODE 4, Sucessful Monitoring, and sensor calibration/pulse search Section 8, Selecting a Masimo routine, or during monitoring. SET Sensor. Radical-7R Pulse CO-Oximeter Operator’s Manual...
Page 58
Not a proper cable. Section 8. May be an incorrect cable, or a defective NO AC CABLE AC Cable not detected. cable. Disconnect and reconnect the cable. Refer to instructions for the cable being used. Radical-7R Pulse CO-Oximeter Operator’s Manual...
Page 59
Disconnect and reconnect into the connector. sensor. Refer to the instructions for the sensor being used. INCOMPATIBLE AC Replace with a proper Masimo sensor. Refer Not a proper Masimo sensor. SENSOR to Section 8. Pulse CO-Oximeter Inoperative or faulty AC sensor; Replace...
T r o u b l e s h o o t i n g T r o u b l e s h o o t i n g The following chart describes what to do if the Radical-7R Pulse CO-Oximeter system does not operate properly or fails.
Page 61
OF DOCKING STATION Match handheld to docking station with handheld and docking CONTINUOUSLY FLASH compatible software versions. station. BATTERY RUN-TIME IS Use Battery Discharge function as Battery Memory effects. SIGNIFICANTLY REDUCED described in Section 4, Service. Radical-7R Pulse CO-Oximeter Operator’s Manual...
Page 62
SpCO/SpMet/SpHb READING Excessive ambient or Shield the sensor from excessive or strobing light. strobing light. Minimize or eliminate motion at the Excessive motion. monitoring site. Also, see Section 4, Successful Monitoring for additional information. Radical-7R Pulse CO-Oximeter Operator’s Manual...
4.11 lbs (1.86 kg) Standalone (RDS-1, RDS-2, RDS-3): 3.8 lbs. (1.73 kg) Standalone (RDS-1B): 5.4 lbs. (2.45 kg) Mode 2, 4, 8,10, 12, 14 or 16 seconds 10 Averaging mode: Normal and Maximum 11 and APOD Sensitivity: Alarms Radical-7R Pulse CO-Oximeter Operator’s Manual...
Page 65
0.9% SpMet. Contact Masimo for testing specifications. 2 The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO 2 against a laboratory CO-Oximeter and ECG monitor.
68% of the population. 5 Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
0.0V to 1.0V. A variance of ± 40 mV is acceptable. NURSE CALL The nurse call feature is available when Radical-7R Pulse CO-Oximeter is operating in its standalone configuration. The nurse call feature on the Radical-7R Pulse CO-Oximeter is based on the relay closing or opening depending on alarm, Low Signal IQ events or both.
To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with a Masimo Optical Shield, if required. Failure to take this precaution in excessive ambient light conditions may result in inaccurate measurements.
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). Acoustic Respiration Sensor The Acoustic Respiration sensor must be used in conjunction with the Acoustic Respiration PC and Dual Rainbow Cable.
• S2-20a with S2-20r Red Direct Connect Sensors Masimo Red sensors can be used with the Radical-7R to enable measurement of SpO 2 and pulse rate only. Red sensors will only function with Pulse CO-Oximeter instruments equipped with Masimo Rainbow SET technology. Red Direct Connect sensors connect to the instrument directly.
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 Radical-7R Pulse CO-Oximeter Operator’s Manual...
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. • Newborn Infant/Pediatric Radical-7R Pulse CO-Oximeter Operator’s Manual...
See Sensor Directions for Use (DFU) for sensor accuracy specifications for: SpO 2 , 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: Remove the sensor from the patient.
DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER HARSH SOLVENTS, TO CLEAN THE PULSE CO-OXIMETER. THESE SUBSTANCES ERODE THE INSTRUMENT’S MATERIALS AND INSTRUMENT FAILURE CAN RESULT. Refer to Section 8, Cleaning and Reuse of Masimo Sensors for cleaning instructions of the sensor. Radical-7R Pulse CO-Oximeter Operator’s Manual...
IT IS NOT IN USE TO ENSURE THAT THE BATTERY REMAINS FULLY CHARGED. The following tables outline the estimated run times of the battery powered Radical-7R Pulse CO-Oximeter. The time estimates are based on a Radical-7R Pulse CO-Oximeter with fully charged batteries.
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. Although it is possible to operate the entire Standalone...
Before performing the following tests place the Radical-7R Pulse CO-Oximeter Handheld into the Docking Station, connect the Radical-7R to AC power and fully charge the Radical-7R Pulse CO-Oximeter Handheld battery. Also disconnect any patient cables or pulse oximetry probes,...
Page 78
Masimo SET Tester's Directions for Use for further instructions. Nurse Call Test: Disconnect the Red patient cable or the Masimo SET Tester from the Radical-7R and turn the instrument on. Ensure that there are no audible alarms and that the audible alarms are not silenced.
Please clean contaminated/dirty equipment before returning. 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. Package the equipment securely – in the original shipping container if possible – and enclose or include the following information and items: ■...
Page 80
S e r v i c e / M a i n t e n a n c e Return Radical-7R Pulse CO-Oximeter to the following shipping address: For USA, Canada & Asia Pacific: For Europe: All other locations: Masimo Corporation Contact your Masimo International Sàrl...
W a r r a n t y 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.
Ownership of Software: The Software is licensed not sold; all rights and interests in the Software and all copies thereof remain at all times vested in Masimo, and do not pass to Purchaser. Any references in this Agreement to the purchase or sale of the Software shall be deemed the purchase or sale of a Software License as set forth herein.
Masimo. There is no license, implied or otherwise, that would allow use of licensed sensors beyond their intended duration. After use of sensors through their designated duration, there is no further license granted by Masimo to use the sensors and the sensors must be discarded or returned to Masimo for reprocessing.
Need help?
Do you have a question about the Radical-7R and is the answer not in the manual?
Questions and answers