Operators Manual
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with color display 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 a prerequisite for its proper use. Do not operate the Radical-7 Pulse CO-Oximeter without completely reading and understanding the instructions in this manual. If a Radical-7 unit has been upgraded to include the latest available parameters by utilizing the upgrade tool (sold separately), please discontinue using the previous Radical-7 manual and use the new manual provided. NOTICE: Purchase or possession of this device does not carry any express or implied license to use this device with replacement parts which would, alone or in combination with this device, fall within the scope of one of the patents relating to this device. CAUTION: Federal law (U.S.) restricts this device to sale by or on the order of a physician. Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU Authorized Representative for Masimo Corporation:
EC REP MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33 MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 606011/CAN/CSA C22.2 No. 601.1 Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,580,086, 6,501,975, 6,463,311, 6,430,525, 6,397,091, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo.com/patents. Products containing Satshare® feature are also covered by U.S. Patent 6,770,028. Other patents pending. © 2007 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, FastSat, Satshare, SET, Radical logo, Signal IQ, LNOP and LNCS are federally registered trademarks of Masimo Corporation. Rainbow and SpCO are federally registered trademarks of Masimo Laboratories. Radical-7, RadNet, RadicalScreen, LNOPv and APOD are trademarks of Masimo Corporation. SpMet and Signal Extraction Pulse CO-Oximeter are trademarks of Masimo Laboratories. Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Radical-7 Signal Extraction Pulse CO-Oximeter is designed to minimize the possibility of hazards from errors in the software program by following sound engineering design processes, Risk Analysis and Software Validation.
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For home use, ensure that the Pulse CO-Oximeter’s alarm can be heard from other rooms in the house especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios are operating.
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Always remove the sensor from the patient and completely disconnect the patient from the Pulse CO-Oximeter before bathing the patient.
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Do not place the Pulse CO-Oximeter where the controls can be changed by the patient.
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Explosion hazard. Do not use the Pulse CO-Oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygenenriched environments, or nitrous oxide.
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High intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the Pulse CO-Oximeter to obtain vital sign readings.
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The Pulse CO-Oximeter is NOT intended for use as an apnea monitor.
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The Pulse CO-Oximeter should be considered an early warning device. As a trend towards patient hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition.
Do not place the Pulse CO-Oximeter face against a surface. This will cause the alarm to be muffled.
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Do not place the Pulse CO-Oximeter on electrical equipment that may affect the Pulse CO-Oximeter, preventing it from working properly.
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The Pulse CO-Oximeter is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read before use.
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Do not expose the Pulse CO-Oximeter to excessive moisture such as direct exposure to rain. Excessive moisture can cause the Pulse CO-Oximeter to perform inaccurately or fail.
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Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to replace the battery of the Handheld unit. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment.
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Do not place containers with liquids on or near the Pulse CO-Oximeter. Liquids spilled on the Pulse CO-Oximeter may cause it to perform inaccurately or fail.
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Failure of Operation - If the Pulse CO-Oximeter fails any part of the setup procedures or leakage tests, remove the Pulse CO-Oximeter from operation until qualified service personnel have corrected the situation.
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Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
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Disposal of product - Comply with local laws in the disposal of the unit and/or its accessories.
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The Pulse CO-Oximeter can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds.
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This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC. These limits are 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 devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
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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.
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Interfering Substances: SpO2 is a functional calculation of arterial oxygen saturation. Carboxyhemoglobin and Methemoglobin may erroneously increase SpO2 readings. The level of increase is approximately equal to the amount of carboxyhemoglobin and/or methemoglobin that is present. Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.
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Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
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Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2 measurements.
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Severe anemia may cause erroneous SpO2 readings.
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Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Pulse CO-Oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.
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As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of the irradiation field. If the sensor is exposed to the irradiation, the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period. Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
■ Reorient or relocate the receiving device. ■ Increase the separation between the equipment. ■ Connect the equipment into an outlet on a circuit different from that to which
the other device(s) are connected. ■ Consult the manufacturer for help.
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A functional tester cannot be utilized to assess the accuracy of the Pulse COOximeter or any sensors.
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table of contents
SECTION 1 - OVERVIEW About This Manual... 1-1 Warnings, Cautions and Notes... 1-2 Product Description... 1-3 Features... 1-3 Indications for use... 1-3 Pulse CO-Oximetry... 1-4 SpO2 General Description... 1-4 SpCO General Description... 1-4 SpMet General Description... 1-4 Principle of Operation... 1-5 Functional vs. Fractional Saturation... 1-6 Measured vs. Calculated Saturation... 1-6 Masimo SET Signal Extraction Technology for SpO2 Measurements... 1-6 SpCO and SpMet Measurements During Patient Motion... 1-6 Masimo rainbow SET Parallel Engines... 1-7 Masimo SET DST ®... 1-7 SECTION 2 - SYSTEM DESCRIPTION Introduction... 2-1 Radical-7 Pulse CO-Oximeter Handheld... 2-2 Handheld Front Panel... 2-2 Main Screen Trend Graph Display... 2-6 Handheld Back Panel... 2-7 Radical-7 Pulse CO-Oximeter Standalone... 2-8 Standalone Front Panel... 2-9 Standalone Back Panel... 2-10 Symbols... 2-11 Radical-7 Monitor Interface... 2-12 SECTION 3 - SETUP Introduction... 3-1 Unpacking and Inspection... 3-1 Preparation for Monitoring... 3-1 Radical-7 Docking Station Power Requirements... 3-1 Initial Battery Charging... 3-2 Initial Installation... 3-2 Monitor Setup... 3-3 Factory Default Settings... 3-3 Custom (User) Defined Settings... 3-3 Adult/Neo (Hospital Defined) Settings... 3-4 Satshare Setup... 3-4 SatShare Setup... 3-5 Spacelabs Universal Flexport Setup... 3-7 RadNet Setup... 3-7
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Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
table of contents
SECTION 4 - OPERATION Introduction... 4-1 Basic Operation... 4-1 General Setup and Use... 4-1 Successful Monitoring... 4-3 Numeric Display - SpO2... 4-3 Masimo Sensors... 4-3 Numeric Display - Pulse Rate... 4-3 Numeric Display - SpCO... 4-4 Numeric Display - SpMet... 4-4 Numeric Display - PI... 4-4 Signal IQ... 4-4 Low Perfusion... 4-5 Actions To Be Taken... 4-5 Sensitivity... 4-6 Touch Key Control Button and Icons... 4-7 Traditional User Interface... 4-7 First Page... 4-7 Second Page... 4-7 Simplified User Interface... 4-8 First Page... 4-8 Second Page... 4-8 Navigating the Main Menu... 4-9 Main Menu Selection... 4-9 Menu Categories... 4-9 Editing a Parameter... 4-10 Menu Tree... 4-10 Alarms... 4-12 Rotate Screen... 4-15 Display... 4-16 General... 4-18 Clock... 4-18 About... 4-19 Config... 4-19 3D Alarm System (optional)... 4-19 Output... 4-20 Service... 4-22 Trend Display... 4-23 Navigating the Trend Display... 4-25 First Page... 4-25 Second Page... 4-25 Third Page... 4-25 Trend Setup... 4-26 Histogram... 4-27 BacklightOperation... 4-28 Satshare Operation... 4-28 Home Mode Operation... 4-30 Password Operation... 4-30
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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table of contents
SECTION 5 - ALARMS AND MESSAGES System Messages... 5-1 3D Alarm System Option... 5-3 Purpose... 5-3 3D Alarm System Overview... 5-3 Desat Index Alarm... 5-3 Perfusion Index (PI) Delta Alarm... 5-3 Desat Index Alarm... 5-4 User Interaction to Implement Desat Index Alarm... 5-5 Perfusion Index (PI) Delta Alarm... 5-6 User Interaction to Implement PI Delta Alarm... 5-6 3D Alarm menu... 5-7 SECTION 6 - TROUBLESHOOTING Troubleshooting... 6-1
table of contents
SECTION 9 - SERVICE AND MAINTENANCE Introduction... 9-1 Cleaning... 9-1 Battery Operation and Maintenance... 9-2 Performance verification... 9-5 Service and repair... 9-9 Repair Policy... 9-9 Return Procedure... 9-9 Warranty... 9-10 Exclusions... 9-10 End-user license agreement... 9-10 SECTION 10 - ACCESSORIES Accessories... 10-1
SECTION 7 - SPECIFICATIONS Radical-7 specifications... 7-1 Performance... 7-1 Accuracy... 7-1 Electrical... 7-1 Environmental... 7-2 Serial interface specifications... 7-4 Serial Interface Setup... 7-4 Serial Printer Setup... 7-5 Analog Output / Nurse Call Specifications... 7-6 Analog Output... 7-7 Calibration... 7-7 Nurse Call... 7-7 SECTION 8 - SENSORS & PATIENT CABLES Introduction... 8-1 Selecting a Masimo SET Sensor... 8-1 Sensor Application instructions... 8-1 Masimo Rainbow Sensors... 8-2 Rainbow Reusable Sensors... 8-2 Rainbow Adhesive Sensors... 8-2 Masimo SpO2 Sensors... 8-3 Red Reusable Sensors... 8-3 LNOP® Reusable Sensors... 8-3 ® LNOP Adhesive Sensors... 8-4 TM LNCS Reusable Sensors... 8-4 TM LNCS Adhesive Sensors... 8-5 TM LNOPv Adhesive Sensors... 8-5 Sensor Accuracy... 8-6 Cleaning And Reuse Of Masimo Reusable Sensors and Cables... 8-6 Reattachment of Single Use Adhesive Sensors... 8-6
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Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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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. In addition to the safety section, this manual includes the following sections: SECTION 1
OVERVIEW gives a general description of Radical-7 Pulse COOximeter.
SECTION 2
SYSTEM DESCRIPTION describes the Radical-7 Pulse COOximeter system and its functions and features.
SECTION 3
SETUP describes how to setup the Radical-7 Pulse CO-Oximeter for use.
SECTION 4
OPERATION describes the operation of the Radical-7 Pulse COOximetry system.
SECTION 5
ALARMS AND MESSAGES describes the alarm system messages.
SECTION 6
TROUBLESHOOTING describes troubleshooting information.
SECTION 7
SPECIFICATIONS gives the detailed specifications of the Radical-7 Pulse CO-Oximeter.
SECTION 8
SENSORS AND PATIENT CABLES outlines how to use and care for Masimo Rainbow SET technology sensors, Masimo Rainbow SET technology patient cables, Masimo Red sensors and Masimo Red PC cables.
SECTION 9
SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Radical-7 Pulse CO-Oximeter.
SECTION 10
ACCESSORIES lists the available Radical-7 Pulse CO-Oximeter accessories.
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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.
A CAUTION is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device or damage to other property. 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.
overview
1
Product Description The Radical-7 Pulse CO-Oximeter is a noninvasive, arterial oxygen saturation 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®*, pulse rate, Perfusion Index (PI) and Pleth Variability Index (PVI). It also provides graphical displays for plethysmographic waveform and Signal Identification and Quality Indicator (Signal IQ®). The Radical-7 Pulse CO-Oximeter can be used to interface with a multiparameter patient monitor to provide only Masimo SET SpO2 information to that monitor for display. FEATURES These features are common to the Radical-7 family: ■ Masimo SET is clinically proven to be the highest sensitivity and specificity pulse oximeter in the world. ■ Rainbow technology uses 7+ wavelengths of light to continuously and noninvasively measure carboxyhemoglobin (*SpCO®) and methemoglobin (*SpMetTM), as well as providing a more reliable probe-off detection. ■ Perfusion Index (PI) with trending capability indicates arterial pulse signal strength and may be used as a diagnostic tool during low perfusion. ■ *Pleth Variability Index (PVI): captures vital thoracic pressure changes that may compromise normal cardiac function affecting systemic circulation. ■ Accurate on cyanotic patients when used with an LNOP® Blue Sensor. ■ Signal IQ® waveform for signal identification and quality indication during excessive motion and low signal to noise situations. ■ FastSat® tracks rapid changes in arterial O2 with high fidelity unlike any other pulse oximeter. ■ Variable pitch provides tonal variance for every 1% change in saturation. ■ SatShare ® interface allows transfer of SpO2 and pulse rate to existing multiparameter monitor and allows for the reading of SpCO and SpMet on adjacent Radical-7 monitor.. ■ Automatic screen rotation provides upright display for vertical or horizontal monitor positioning. ■ Remote alarming interface. ■ Up to eighteen days of trending. ■ Detachable portable hand-held for patient transport. ■ 3D Alarm System Option: ■ Desat Index AlarmTM enables clinicians to detect an increasing quantity of smaller desaturations that may precede declining respiratory status. ■ PI Delta AlarmTM alerts clinicians to specified changes in perfusion, often a reliable indicator of illness severity. INDICATIONS FOR USE The Radical-7 Pulse CO-Oximeter and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin percentage and methemoglobin percentage (measured by a SpCO/SpMet sensor). The Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile and home environments. * Optional parameters
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overview
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overview
Pulse CO-Oximetry
PRINCIPLE OF OPERATION
SpO2 GENERAL DESCRIPTION Pulse CO-Oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for neonates. The sensor is connected to the Pulse CO-Oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data in three ways:
Pulse CO-Oximetry is governed by the following principles: 1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood) carboxyhemoglobin (blood with carbon monoxide content) and methemoglobin species differ in their absorption of visible and infrared light (using spectrophotometry, see figure below).
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2.
As a pulse rate (PR)
3.
As a plethysmographic waveform
The following figure shows the general monitoring setup.
Carboxyhemoglobin Oxyhemoglobin Methemoglobin
As a percent value for arterial oxygen saturation (SpO2) Absorption (mm-1)
1.
Absorption Spectra
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Deoxyhemoglobin
4
2
0 600
650
700
2. Patient Cable 3. Sensor
SpCO GENERAL DESCRIPTION Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels of carbon monoxide concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpCO 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 an instrument 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 SpCO, which reflect blood levels of carbon monoxide bound to hemoglobin. SpMet GENERAL DESCRIPTION Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels of methemoglobin concentration (SpMet) in arterial blood. It relies on the same basic principles 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 an instrument 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.
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Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
750
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850
900
950
1000
Wavelength (nm)
1. Instrument
2. The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well. The Radical-7 Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide content and blood with oxidized hemoglobin. The Radical-7 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a photodiode (photodetector). See figure below. Signal data is obtained by passing various visible and infrared lights (LED’s, 500 to 1000nm) 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 22mW. The photodetector receives the light, converts it into an electronic signal and sends it to the Radical-7 for calculation. 1
1. Light Emitting Diodes (LEDs) (7 + wavelengths) 2
2. Recessed Photo Detector
Once the Radical-7 receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology to calculate the patient’s functional oxygen saturation, blood levels of carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pulse rate. The SpCO and SpMet measurements rely on a multiwavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin in arterial blood. The maximum of the skin surface temperature is measured at an ambient temperature of less than 106º F (41º C). This is verified by Masimo sensor skin temperature test procedures
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1
overview
1
overview
FUNCTIONAL SATURATION
MASIMO RAINBOW SET PARALLEL ENGINES
The Radical-7 is calibrated to measure and display functional saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. Note that carboxyhemoglobin is not capable of transporting oxygen, but is recognized as oxygenated hemoglobin by conventional pulse oximetry.
This figure is for conceptual purposes only.
MEASURED VS. CALCULATED SATURATION SpO2, SpCO and SpMet measurements that can be obtained from the Radical-7 are commonly compared to invasive measurements obtained from blood gas samples. When comparing invasive and noninvasive measurements and interpreting values, caution should be used, as the calculated values obtained from the blood gas sample may differ from the SpO2, SpCO and SpMet measurements of the Pulse CO-Oximeter. In the case of SpO2, different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. In the case of SpCO and SpMet, in addition to the effects of temperature and pH, different results are also expected if concentration of methemoglobin in the blood gas sample are abnormal (less than 90% for arterial oxygen saturation, and greater than 2% for methemoglobin concentration). As blood gas samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a meaningful comparison can only be achieved if the oxygen saturation, carboxyhemoglobin and methemoglobin concentration of the patient are stable and not changing over the period of time that the blood gas sample is taken. MASIMO SET SIGNAL EXTRACTION TECHNOLOGY FOR SpO2 MEASUREMENTS Masimo Signal Extraction Technology’s signal processing differs from conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the non-arterial blood also moves, causing conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform® (DST)®, reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.
LED Wavelengths
R/IR (Conventional Pulse Oximetry)
Intermediate Calculations
DST ® Adaptive Filter
Intermediate Calculations
Confidence
Confidence
Intermediate Calculations
Pre-Processing & Data Reduction Digitized, Filtered & Normalized
SST ™
Confidence
FST: Proprietary Algorithm 3
Intermediate Calculations
FST: Proprietary Algorithm 4
Intermediate Calculations
Rainbow Specific Algorithms
Intermediate Calculations
Pulse Rate Algorithm
Intermediate Calculations
Confidence Based Arbitrator
Post Processor
Confidence
Confidence
%SpO2 %SpCO
Confidence
%SpMet
Confidence
PI PR
MASIMO SET DST ®
SpCO AND SpMet MEASUREMENTS DURING PATIENT MOTION The Radical-7 displays measurements of SpCO and SpMet 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 readable during excessive motion.
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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. All pulse oximetry measurement information, as well as device status data is displayed on the Handheld LCD screen. All user input is performed through the control buttons on the front panel. The sensor cable connector is located on the Radical-7 Handheld Pulse CO-Oximeter. The Handheld Pulse CO-Oximeter snaps into the Radical Docking Station to provide a fully featured standalone Pulse CO-Oximeter. The Docking Station connects to AC power for standalone operation or charging of the Handheld. An optional Docking Station battery is available. The standalone Radical-7 features nurse call, analog output and interfaces to serial printers. Utilizing a SatShare® cable, the standalone Radical-7 also interfaces with the SpO2 input of a validated multiparameter patient monitor*, instantly upgrading the conventional pulse oximetry to Masimo SET pulse oximetry. The SatShare cable attaches to the back of the Radical Docking Station, and SatShare cables are available to interface with most multiparameter patient monitors*. CAUTION: ■ THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL (NON-NORMALIZED). REFER TO THE RADICAL-7 PULSE CO-OXIMETER DISPLAY FOR PATIENT WAVEFORM. ■ IF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE, IT IS RECOMMENDED TO TURN OFF THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR. ■ ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED. ■ SpCO AND SpMet CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH SATSHARE. Refer to Section 3, SatShare Setup and Section 4, SatShare Operation for additional details. *Contact Masimo for the latest list of SatShare validated multiparameter monitors. Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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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 sensor cable connects into the connector on the Handheld unit. 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
HANDHELD RELEASE BUTTON
1
SpO
2
HANDHELD FRONT PANEL The following figure and corresponding text outline all the features of the Handheld Radical7 Pulse CO-Oximeter: Pleth + Signal IQ View 3
2 97 MEASUREMENT DISPLAY
Masimo rainbow SET
99 4
85
5
Numbers View
6
1.65
3.0 7
8
9
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Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
0.3
Sensor Off
20
MASIMO SET OR MASIMO RAINBOW SET SATURATION ALARM LIMITS DISPLAY
2
Press down the Handheld Release Button and pull the Handheld device off the Docking Station. 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 during pulse search, the display will show dashed lines and the message Sensor Off will appear at the top of the display screen. When the measured value is outside of the alarm limits, the SpO2 Measurement Display flashes and an alarm will sound. The oxygen saturation is calculated and the display is updated at a frequency of once per second. The Masimo SET or Masimo rainbow SET label is shown on the Radical-7 display when either SET processing is active. NOTE: Patient information, not SET activity will be displayed when using a RadNet compatible unit connected to a RadNet central station. The Saturation Alarm Limits Display shows the upper and lower saturation alarm limits. When an alarm limit is exceeded, the SpO2 value and the violated limit flashes.
The alarm status indicator (a bell) can be shown with or without a slash. It flashes when an alarm condition is present. When the alarm is silenced using the Alarm Silence Button, ALARM STATUS an alarm status indicator with a slash and a timer is shown to indicate that the alarm is temporarily silenced. When the INDICATOR alarm is silenced through the All Mute menu selection (which is permanent until power is cycled or deselected using the menu) an alarm status indicator with a slash is shown to indicate that alarm has been silenced. The measurement of methemoglobin concentration levels is displayed in units of percentage SpMet. The upper and lower SpMet alarm limits are also displayed next to the SpMet measurement. When a sensor is not connected to SpMet* MEASUREMENT a patient and during pulse search, the display will show DISPLAY dashed lines and the message Sensor Off will appear at the top of the display screen. The methemoglobin is calculated and the display is updated at a frequency of once per second. The SpMet Alarm Limits Display shows the upper and lower SpMet ALARM alarm limits. When the measured value is outside of the LIMITS DISPLAY alarm limits, the SpMet measurement display flashes and an alarm will sound. The system messages generated by the instrument are disSYSTEM played in the System Message Area. See Section 5, System MESSAGE AREA messages.
SpCO* MEASUREMENT DISPLAY
The measurement of carbon monoxide concentration levels is displayed in units of percentage SpCO. When a sensor is not connected to a patient and during pulse search, the display will show dashed lines and the message Sensor Off will appear at the top of the display screen. The carboxyhemoglobin is calculated and the display is updated at a frequency of once per second.
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2
system description
The SpCO Alarm Limits Display shows the upper and lower alarm limits. When the measured value is outside of the alarm limits, the SpCO measurement display flashes and an alarm will sound The Pulse Waveform Display shows the acquired plethysmoPULSE graph waveform. The pleth waveform is scaled with signal WAVEFORM strength. Signal strength is defined as the relation of arterial DISPLAY pulsatile signal to the non-pulsatile signal component. The Battery Status Indicators show the capacity of the Radical-7 Handheld and optional Docking Station batterBATTERY ies. The indicator flashes when less than 15 minutes of batSTATUS tery life is left and the battery needs to be recharged. The INDICATORS Docking Station Battery Status indicator is not shown when the optional Docking Station battery is not present. TOUCH KEY Press a Touch Key Control Button to select the correspondCONTROL ing touch key icon. See Section 4, Touch Key Control BUTTONS Buttons and Icons for more details. Press the Backlight Button to change the illumination level of the backlight. With the AC line power connected, four levels of illumination are available (in addition to the no BACKLIGHT illumination level). In the Handheld mode, three levels of BUTTON illumination are available (again in addition to the no illumination level). Use the lowest illumination for most efficient battery usage. Press the Alarm Silence Button to temporarily silence patient and low battery alarms. Press the Alarm Silence Button when the SENSOR OFF message is flashing (i.e. the sensor is removed from the patient) to acknowledge the end of monitoring. In this state, all further alarms are ALARM SILENCE suspended until the Pulse CO-Oximeter starts measuring BUTTON SpO2, SpMet, SpCO and pulse rate again.
50 10
SpCO ALARM LIMITS DISPLAY
5
11
12
13
14
15
16
SPEAKER
17
PATIENT CABLE CONNECTOR
18
POWER/ON/OFF BUTTON
19
20
2-4
MAX
TREND
APOD
GRAPH
10/11/06 12:23:11am
TOUCH KEY ICONS TIME AND DATE INDICATOR
NOTE: System failure alarms can be silenced by pressing the Power/Standby or Alarm Silence Button. If the Power/ Standby Button does not silence the system fault alarm, press the Alarm Silence Button The speaker indicates audio alarms. Care should be taken not to cover the speaker and muffle the audible alarm volume. Connect a patient cable or a direct cable sensor into the Handheld Radical-7 by plugging the cable into the Patient Cable Connector. Use only Masimo compatible sensors and cables with this oximeter. See Section 8, Sensors and Patient Cables for more details. Press the Power/On/Off Button to turn the instrument on. Press, hold the button for more than 2 seconds and then release the button to turn the instrument off. The Touch Key Icons indicate the software menu items that can be selected through the Touch Key Control Buttons. Pressing a Touch Key Control Button next to an icon selects the option. The Time and Date Indicator displays the current time and date. The time is displayed in 12 or 24 hour format. The date is displayed in dd/mm/yy or mm/dd/yy format. Select the date and time display formats in the Clock menu.
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
system description
21
SIGNAL IQ
The Signal IQ shows the acquired signal quality and the timing of the pulse. A tall vertical line indicates a high quality signal, while a small vertical line indicates a low quality signal. The Signal IQ may will be displayed as a single, pulsating bar in the Numbers mode.
22
BRIGHTNESS LEVEL
The Brightness level icon displays when utilizing the Backlight/Contrast button.
23
3.00 PERFUSION
24
APOD
SENSITIVITY
140
PULSE RATE ALARM LIMITS DISPLAY
25
26
PI
50
FastSat
INDEX
FASTSAT
27
76 PULSE RATE
28
Philips VueLink
29
5
2
The Perfusion Index indicates numerically the percentage of pulsatile signal to non-pulsatile signal (pulse strength). The MAX or APOD™ sensitivity icon is shown on the Radical-7 display to indicate if the Radical-7 is set to operate in Normal sensitivity, Maximum sensitivity or Adaptive Probe Off Detection mode The Pulse Rate Alarm Limits Display shows the upper and lower pulse rate alarm limits. When an alarm limit is reached or exceeded, the pulse rate value and the violated limit flashes. The FastSat® label is shown on the Radical-7 display whenever the Radical-7 is set to operate in the FastSat mode. The Pulse Rate Measurement Display shows the patient’s pulse rate in beats per minute. The upper and lower pulse rate alarm limits are also displayed next to the pulse rate measurement. The pulse rate is calculated and the display is updated at a frequency of once per second.
SERIAL OUTPUT MODE
The Serial Output Mode displays the selected output interface when interfaced with the Docking Station. and connected to the serial port with the selected Satshare cable.
PLETH VARIABILITY INDEX
The Pleth Variability Index indicates numerically the percentage of variation in the pleth waveform as a result of a inhalation and exhalation cycle.
* For instruments that include SpMet and SpCO parameters: the SpMet and SpCO parameters will be grayed out in the display screen if a patient cable is not attached or a non-Rainbow sensor is being used. NOTE: The Pulse CO-Oximeter display view will be different without the optional SpCO and SpMet options.
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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
1
The first top line of the trend graph display shows the time scale of the trend graph followed by the selected parameter. The parameter’s numeric value is highlighted.
2
The second top line of trend graph display shows the minimum, maximum and average measurement of the selected parameter contained in the displayed data set (excluding zero measurements).
3
The Trend Graph control button initates the trend graph display. Repeatedly pressing down on the button will step through each parameter, highlighting the numeric value and displaying the parameter above the trend graph.
4
The lines on the trend graph indicate the minimum and maximum values of the parameter.
5
The trend graph shows the desired parameter measurements displayed versus time and the accuracy range
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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1251 0000 536
11328/2269M-0805
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 by allowing to step through and selecting the desired parameter. This is done by repeatedly pressing down on the Trend Graph control button. Once the parameter is selected, the numeric value is highlighted and the selected parameter is displayed above the trend graph.
2
system description
Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo.com/patents. Products containing Satshare® feature are also covered by U.S. Patent 6,770,028. Other patents pending.
system description
MEDICAL ELECTRICAL EQUIPMENT UL 2601-1/CAN/CSA C22.2 No. 601.1 80FK
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 accessories for attachment instructions.
3
BATTERY PACK
The Radical-7 Handheld is powered by a NiMH battery located in this compartment. For battery care and replacement please see Section 9, Replacing the Batteries.
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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 device. The Radical-7 Pulse CO-Oximeter Standalone acts as a battery charger for the Handheld device and has AC power connection capabilities. If the mains supply is temporarily interrupted, then the battery in the Handheld device will allow continuous operation. The Standalone can also interface to serial devices, nurse call or analog output devices, and multiparameter patient monitors through a SatShare cable.
system description
2
STANDALONE FRONT PANEL The following figure and corresponding text review the features of the Radical-7 Standalone device.
There are several models of Docking Stations available. The following table outlines which features are available for each model of Docking Station. RDS-1
RDS-1B
AC Power Input
DOCKING STATION FEATURES
RDS-2
RDS-3
SatShare Interface
Serial RS-232 Interface
Nurse Call/Analog Output Interface
The Docking Station Battery Charging Indicator is illuminated when the Docking Station battery is charging. The indicator blinks just prior to charging. The charging indicator does not illuminate when the battery is fully charged or when the battery is not present.
2
HANDHELD BATTERY CHARGING INDICATOR
The Handheld Battery Charging Indicator is illuminated when the Handheld battery is charging. The indicator blinks just prior to charging. The Charging Indicator does not illuminate when the battery is fully charged or when the battery is not present.
3
VISUAL ALARM INDICATOR
The Visual Alarm Indicator is illuminated when an alarm condition is active and the Alarm Status Indicator is shown.
4
AC POWER INDICATOR
The AC Power Indicator is illuminated when the Radical7 Docking Station is plugged into AC line power.
5
DOCKING INDICATOR
The Docking Indicator is illuminated when the Handheld unit is turned on and is properly interfaced to a Docking Station.
10-hour Extended Battery Automatic Display Rotation Support (Gravity Detector)
Docking Station Battery Charging Indicator
Handheld Battery Charging Indicator
Visual Alarm Indicator
AC Power Indicator
Docking Indicator
Handheld Battery Deep Discharge Support
Docking Station Battery Deep Discharge Support
The RDS-1 and RDS-3 are optionally available with RadNet capability. (Refer to Section 3 RadNet Setup for details)
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1
DOCKING STATION BATTERY CHARGING INDICATOR
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
NOTE: When the Radical-7 Pulse CO-Oximeter Standalone is turned on, all indicator LEDs initially turn on and off at start up.
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system description
STANDALONE BACK PANEL 1
2
SYMBOLS The following symbols are found on the Radical-7 Pulse CO-Oximeter, Docking Station or packaging and are defined below:
3
2
system description
NOTE: Some of the interfaces and symbols are not available in all versions of the Docking Station. P1
P2
P3
SYMBOLS
MEDICAL ELECTRICAL EQUIPMENT UL 60601-1/CAN/CSA C22.2 No. 601.1 80FK
Rx Only
DEFINITION
RS-232
Manufactured by: Masimo Corporation Irvine, CA 92618 USA Made in USA
SatShare Interface
Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo.com/patents. Products containing Satshare®
Equipotential Ground Terminal 5
See Instructions for Use
4
Fuse Replacement
1
2
3
4
SERIAL OUTPUT CONNECTOR
ANALOG OUTPUT / NURSE CALL CONNECTOR
Use the Analog Output Connector with a ferrite bead installed to interface with an analog output device, such as a chart recorder or nurse call system. All external device connections to the Analog Output / Nurse Call Connector must be IEC60950 compliant.
SATSHARE CABLE CONNECTOR
Use the SatShare Cable Connector to connect a SatShare cable to the SpO2 input connector of a multiparameter patient monitor. All external device connections to the SatShare Cable Connector must be IEC-60601-1-1 compliant. SatShare cables are available to interface with most major multiparameter patient monitors. Check the label on the SatShare cable and the SatShare Directions for Use to ensure that the correct cable is used for each type of patient monitor. Refer to Section 10 - Accessories of this manual or the Masimo web site at www.masimo.com for the latest SatShare cables and validated instruments.
POWER ENTRY MODULE
Analog Out Interface
Use the Serial Output Connector with a ferrite bead installed to connect a serial device, including a serial printer, RadNet Interface Module 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 device connections to the Serial Output Connector must be IEC-60950 compliant.
The power entry module contains the input connector for AC power and two fuses. The AC input provides power to the system from the AC line. Always connect the Pulse CO-Oximeter to the mains power for continuous operation and/or battery recharging.
Nurse Call Interface WEEE Compliant
Rx ONLY
Mark of Conformity to European Medical Device Directive 93/42/EEC Federal law restricts this device to sale by or on the order of a physician (USA audiences only) Underwriter's Laboratories Inc. approved
5%-95% RH
+70 C
-40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg
Storage humidity range: 5% to 95% Storage temperature range: +70˚C to -40˚C Storage altitude range: +1600hPa to +500hPa Keep dry Fragile/breakable, handle with care Year of Manufacture
IPX1
Protection against liquid drops falling vertically. Defibrillation Proof Type BF
NOTE: Use the power cord as the means to disconnect the device from the mains power supply. 5
2-10
EQUIPOTENTIAL GROUND CONNECTOR
Use the Equipotential Ground Connector for grounding.
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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system description
setup
Radical-7 Monitor Interface
Introduction
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 COOximeter to most existing multiparameter patient monitors through the pulse oximetry patient cable or SpO2 input connector.
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.
3
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. If anything is missing or damaged, contact the Technical Service Department. The contact address and phone numbers are listed in Section 9, Service and Repair. Preparation for Monitoring
■
Upgrades any approved and validated monitor to Masimo SET performance by using the calculated SpO2 and pulse rate determined by Radical-7 to simulate an ideal waveform, which is sent to the validated multiparameter patient monitor.
■
Connects into the SpO2 patient cable or SpO2 input connector of the multiparameter patient monitor.
Refer to Section 3, SatShare Setup and Section 4, SatShare Operation for additional details. CAUTIONS: ■
2-12
THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL (NON-NORMALIZED). REFER TO THE RADICAL-7 PULSE CO-OXIMETER DISPLAY FOR PATIENT WAVEFORM.
■
IF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE, IT IS RECOMMENDED TO TURN OFF THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR
■
ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.
■
SpCO AND SpMet CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH SATSHARE.
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
The following sections of the manual describe the preparation, set-up and initial installation of the Radical-7 Pulse CO-Oximeter. RADICAL-7 DOCKING STATION POWER REQUIREMENTS Always use a hospital grade, AC power cable to connect the Radical-7 Pulse COOximeter to an AC power source. Do not connect the Radical-7 Docking Station to an AC outlet controlled by a switch because the power to the instrument may be inadvertently be switched off. Verify the AC power voltage and line frequency before use. Verify that the power source can provide adequate power rating as indicated on the rear panel of the Radical-7 Docking Station. The Radical-7 Pulse CO-Oximeter is designed to operate on 100 to 240VAC, 47-63 Hz. The device is rated at 55 VA max. Connect a hospital grade power cable to the power entry module of the Radical-7 unit (IEC-320 connector type at the unit). Connect the power cable to an AC power source. Ensure that the unit is adequately powered by verifying that the AC power indicator on the Docking Station is illuminated. CAUTION: ■ DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUNDING CONDUCTOR FROM THE POWER PLUG. ■ DO NOT USE EXTENSION CORDS OR ADAPTERS OF ANY TYPE. THE POWER CORD AND PLUG MUST BE INTACT AND UNDAMAGED. ■ USE THE POWER CORD AS THE MEANS TO DISCONNECT THE DEVICE FROM THE MAINS POWER SUPPLY ■ IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE EARTH CONDUCTOR ARRANGEMENT, OPERATE THE OXIMETER ON INTERNAL BATTERY POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS FULLY FUNCTIONAL. ■ TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS. ■ DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL SWITCH OR DIMMER. Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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setup
INITIAL BATTERY CHARGING Before use, the Radical-7 Pulse CO-Oximeter Handheld battery and the optional Docking Station battery needs to be fully charged. To charge the batteries: 1.
Attach the Handheld unit 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.
The battery charging LED indicators on the Docking Station flash prior to charging and remain illuminated while the batteries are charging. Refer to Section 9, Battery Operation and Maintenance, for proper battery charging. INITIAL INSTALLATION Place the Docking Station on a stable hard flat surface near the patient. Always place the Radical-7 Pulse CO-Oximeter unit on a dry surface. Maintain a minimum of 3 cm (1 inch) free space around the Radical-7 Pulse CO-Oximeter Standalone unit. Make sure that the Radical-7 loudspeaker is not covered to avoid a muffled alarm sound. The Radical-7 Pulse CO-Oximeter Handheld, Docking Station or Standalone should not be operated outside the following environmental conditions: OPERATING ENVIRONMENTAL CONDITIONS TEMPERATURE
Monitor Setup The Radical-7 Pulse CO-Oximeter maintains three types of default values which 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. FACTORY DEFAULT SETTINGS The following outlines the Radical-7 Pulse CO-Oximeter option settings that can be changed by the user but will revert back to after a power cycle. OPTION LCD SCREEN ILLUMINATION AC Power Battery Power
Set to maximum, level 4 Set to minimum, level 1
SENSITIVITY
Set to APOD mode
DEFAULT SETTING
CUSTOM (USER) DEFINED SETTINGS This mode is indicated by “Mode Custom” on the Alarms menu. The following table outlines the options that may be changed by the user and the Radical-7 Pulse CO-Oximeter will remember after a power cycle. The default settings listed below are those set at the factory and will revert back to if the user chooses to recall the factory settings. (see Section 4, Display). OPTION
+5°C to +40°C, +41°F to +104°F
FACTORY DEFAULT SETTING
CONFIGURABLE SETTING
DISPLAY VIEW
Set to Pleth + SigIQ
AVERAGING TIME
Set to 8
FASTSAT
Set to No
Pleth + SigIQ, Pleth Only, Numbers 2, 4, 8, 10, 12, 14, or 16 seconds Yes/No
Configure the unit for your regional power line frequency (50 or 60 hz) if needed. Default is 60 hz (standard for the United States). See Section 4, Operation, Config.
HOME USE
Set to No
Yes/No
INTERFACE ALARMS
Set to Yes
Yes/No
CAUTION: THE UNIT MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER LINE FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED BY FLUORESCENT LIGHTS AND OTHER SOURCES.
SATSHARE NUMBERS
Set to Yes
Yes/No
POWER SAVE DATE FORMAT TIME FORMAT
Set to No Set to mm/dd/yy Set to 12 hr.
Yes/No mm/dd/yy and dd/mm/yy 12 and 24 hour
LANGUAGE
Set to English
HUMIDITY
5% to 95%, non-condensing
OPERATING ALTITUDE
1060 mbar to 500 mbar pressure -1000 ft to 18,000 ft (-304 m to 5,486 m)
ANALOG OUTPUT
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setup
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
See Section 4, Display for all settings Set to Analog 1: SpO2 0-100% See Section 4, Display for all Set to Analog 2: Pulse Rate settings
SERIAL OUTPUT PORT MODE
Set to Binary
ASCII 1, ASCII 2, Binary, Philips Vuelink, Spacelabs Flexport
PULSE BEEP VOLUME ALARM VOLUME
Set to Level 4 Set to Level 3
Level 1 to 7 Level 1 to 4
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setup
OPTION
FACTORY DEFAULT SETTING
TREND DISPLAY PARAMETERS
Set to %SpO2 + BPM
TREND PERIOD
Set to 1 Hr.
LOW SpO2 ALARM LIMIT
Set to 0
SpMet HIGH/LOW ALARM LIMIT SpCO HIGH/LOW ALARM LIMIT SMART TONE
Set to High: 3.0/Low: --Set to High: 10/Low: --Set to No
CONFIGURABLE SETTING
SATSHARE SETUP
See Section 4, Display for all settings. See Section 4, Trend Setup for all settings. (Refer Section 4, Display for details on this user adjustable feature)
1.
SPO2 HIGH/LOW ALARM LIMIT PULSE RATE HIGH/LOW ALARM LIMIT SpMet HIGH/LOW ALARM LIMIT SpCO HIGH/LOW ALARM LIMIT ALARM SILENCE
CUSTOM SETTING (DEFAULT)
Connect the other end of the SatShare cable either to the sensor connector of the multiparameter monitor’s SpO2 cable or directly to the SpO2 connector on the monitor.
4.
Verify that the Radical-7 Pulse CO-Oximeter recognizes the correct cable. The name of the SatShare cable will be displayed on the LCD screen when the SatShare mode is functional.
5.
Set the multiparameter monitor’s high and low saturation and pulse rate alarm limits as appropriate.
6.
Set the multiparameter monitor’s averaging time to the lowest setting (i.e. fastest response). The Radical-7 Pulse CO-Oximeter’s ideal waveform necessitates the need for additional averaging by the monitor. If the multiparameter monitor’s averaging time is not changed, the time to display physiological changes in saturation on the monitor will be increased with SatShare. However, the delay can be minimized by reducing the multiparameter monitor’s averaging time.
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.
To use the Radical-7 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. Please note that if the Radical-7 Pulse CO-Oximeter is used in this mode, the length of time the Radical-7 Pulse CO-Oximeter can operate on battery power will be significantly diminished.
Same settings Set to High: 10/Low: --Set to 120 seconds Set to 3 Set to 5
The SatShare feature provides an ideal, simulated waveform corresponding to the measured saturation and pulse rate values determined by the Masimo SET technology. This waveform may be used to display these values on multiparameter monitors through the multiparameter ’s oximetry sensor or input connector. It is recommended that the Radical-7 Pulse CO-Oximeter is positioned close to the multiparameter monitor with the Radical-7 Pulse CO-Oximeter screen visibly displaying the plethysmographic waveform and the saturation and pulse rate measurements. CAUTION: SIMULTANEOUS USE OF SATHSARE AND SERIAL PORT IS NOT SUPPORTED. Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
list of available SatShare cables and validated instruments. Connect the labeled end of the cable to the SatShare Cable Connector port on the back of the Docking Station. Tighten the connector screws for a secure connection.
3.
Set to High: 3.0/Low: ---
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.
3-4
2.
ADULT / NEO SETTING (PRE DEFINED)
Set to High: 140/Low: 50 BPM
ALARM DELAY
Select the SatShare cable that is appropriate for the multiparameter monitor that is being connected. Check the Masimo web site at www.masimo.com for the latest
Yes/No
Set to High: ---/Low: 90
ALARM VOLUME
3
See Section 4, Alarms for all settings.
ADULT/NEO (HOSPITAL DEFINED) SETTINGS The following table outlines settings that may be defined by the hospital. If enabled (via a password protected screen, see Section 4 Password Operation), these settings will return to pre defined values after a power cycle. This mode is indicated by “Mode Adult” or “Mode Neo” on the Alarms menu. See Section 4, Operation for details on enabling and setting these parameters. OPTION
setup
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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setup
9.
setup
Set the SatShare Numbers and the Interface Alarms parameters in the General menu according to Customer preference. The Interface Alarms cannot be disabled if the SpCO and SpMet parameters are present in the Radical-7.
3.
of the Docking Station. Connect the other end of the VueLink cable to the VueLink module and insert the module into the Philips monitor rack.
10. If displaying the simulated waveform is not desirable, it is recommended to turn off the pleth waveform display of the multiparameter patient monitor.
4.
The SpO2 and pulse rate values will automatically appear on the Philips monitor.
5.
In order for the pleth waveform to be displayed on the Philips monitor and for the Philips monitor to indicate the alarm conditions measured by the Pulse CO-Oximeter, the user must configure the Philips monitor. Refer to the Philips Operator’s Manual for complete instructions.
6.
The Radical-7 can be set up to audibly indicate all patient alarms while communicating with the Philips VueLink module. Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical-7.
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. WHEN THE AUDIBLE ALARM IS MUTED (INDICATED BY THE BELL WITH A SLASH THROUGH IT) ON THE RADICAL-7 PULSE CO-OXIMETER, USE THE MULTIPARAMETER MONITOR FOR AUDIBLE ALARM INDICATION. THE AUDIBLE ALARMS CANNOT BE MUTED IF THE SpCO AND SpMet PARAMETERS ARE PRESENT IN THE RADICAL-7. DURING SATSHARE OPERATION DO NOT USE THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC PURPOSES. INSTEAD, USE THE PLETH WAVEFORM DISPLAYED ON THE RADICAL-7 PULSE CO-OXIMETER SCREEN. TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL-7 PULSE CO-OXIMETER IS CONNECTED TO THE AC MAINS POWER SUPPLY. ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED. SpCO AND SpMet CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH SATSHARE. Philips VueLink Setup CAUTIONS:
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Spacelabs Universal Flexport Setup CAUTIONS:
SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED. SpMet AND SpCO CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH FLEXPORT.
1.
Select the Spacelabs Flexport selection from the Output menu on the Radical-7.
2.
Connect one end of the Spacelabs Flexport cable to the Serial Output connector on the back of the Docking Station.
3.
Connect the other end of the Spacelabs Flexport cable to the Spacelabs Universal Flexport connector.
4.
The SpO2 and pulse rate values will automatically appear on the Spacelabs screen.
5.
In order for the pleth 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. Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical-7 Pulse CO-Oximeter.
WARNING: EXTERNAL DEVICE CONNECTIONS TO THE SATSHARE PORT MUST BE IEC-60601-1-1 COMPLIANT.
RadNet Setup
SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED.
IF THE RADICAL DOCKING STATION IS COMPATIBLE WITH RADNETTM, VUELINK IS NOT SUPPORTED.
SpCO AND SpMet CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH VUELINK.
1.
Select the Philips VueLink selection from the Output menu on the Radical-7 Pulse CO-Oximeter. Refer to Section 4, Output. Connect one end of the VueLink cable to the Serial Output connector on the back
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Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
CAUTIONS:
SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED. SpMet AND SpCO CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH RADNET. NOTE: Confirm that the Radical Docking Station is RadNet Ready before preceeding. This is done by pressing the Menu button then selecting About. Confirm that the “D-Station” software displays (RadNet) next to the version number.
1.
Select the ASCII 2 selection from the Serial options on the Output Menu on the Radical-7 Pulse CO-Oximeter.
Radical-7 Color Display Signal Extraction Pulse CO-Oximeter Operator’s Manual
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