Rad-87 ™ Pulse CO-Oximeter O P E R AT O R ’ S M A N U A L
The Rad-87 Operating Instructions provide the necessary information for proper operation of all models of the Rad-87 instrument. General knowledge of pulse CO-Oximetry and an understanding of the features and functions of the Rad-87 are a prerequisite for its proper use. Do not operate the Rad-87 without completely reading and understanding the instructions in this manual.
Safety Information, Warnings, Cautions and Notes The Rad-87™ 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. ■ Explosion hazard. Do not use the Rad-87 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
Safety Information, Warnings, Cautions and Notes, continued ■ ■ Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2 measurements. Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet®, SpCO, SpHb® and SpOC™ measurements. ■ Motion artifact may lead to inaccurate SpMet, SpCO, SpHb and SpOC measurements. ■ Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet measurements. ■ Severe anemia may cause erroneous SpO2 and SpOC readings.
Safety Information, Warnings, Cautions and Notes, continued 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: ■ 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.
Table of Contents Safety Information, Warnings, Cautions and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii SECTION 1 - OVERVIEW About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Warnings, Cautions and Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents SECTION 4 - OPERATION Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 General Setup and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents Download Trend Data from Rad-87. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Erasing Trend Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setup Menu Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SpO2 Averaging Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SpHb Averaging . . . . . . . . . . . . . . . . . .
Table of Contents Alarm Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8 Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9 SECTION 6 - TROUBLESHOOTING Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 viii SECTION 7 - SPECIFICATIONS Rad-87 Specifications . . . . . . . . . .
Table of Contents Sensors Licensed for Monitoring Use Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7 SECTION 10 - PART NUMBERS Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview 1 About This Manual This manual explains how to set up and use the Rad-87 Pulse CO-Oximeter containing Masimo Rainbow SET technology. Important safety information relating to general use of the Rad-87 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 Rad-87 Pulse CO-Oximeter Monitor is a noninvasive, arterial oxygen, carboxyhemoglobin, methemoglobin saturation, total hemoglobin concentration, total arterial oxygen content, pulse rate and respiration rate monitor.
1 Overview Indications for Use The Masimo Rainbow SET® Rad-87 Pulse CO-Oximeter and accessories are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration and/or respiratory rate (RRa).
Overview 1 instrument. The instrument displays the calculated data as percentage value for the SpMet. SpHb (Total Hemoglobin) General Description Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make the SpHb measurement. The measurement is taken by a sensor capable of measuring SpHb, usually on the fingertip for adults and pediatric patients.
Overview 1 Principle of Operation Pulse CO-Oximetry is governed by the following principles: 1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry, see figure below). Absorption Spectra 4.0 Carboxyhemoglobin 3.
Overview 1 Functional Saturation The Rad-87 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. Rad-87 vs.
1 Overview Rainbow Acoustic Monitoring Rainbow Acoustic Monitoring is a real time, continuous, non-invasive method for measuring respiration rate based on respiratory sounds. Respiratory sounds include sounds related to respiration such as breath sounds (during inspiration and expiration), adventitious sounds, cough sounds, snoring sounds, sneezing sounds, and sounds from the respiratory muscles [1].
Overview 1 Signal Processing The digital signal produced by the acquisition system is converted into a measurement that corresponds to the respiratory parameter of interest. As shown in the figure on the previous page, this can be performed by, for example, determining the digital signal envelope or outline which in turn may be utilized to determine the respiratory rate.
1 Overview Masimo Rainbow SET Parallel Engines This figure is for conceptual purposes only.
System Description 2 Intro d u ct io n The Rad-87 Pulse CO-Oximeters are full featured devices designed for ease of operation. All pulse CO-Oximetry measurement information, as well as instrument status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel. The sensor cable connections are located on the left side of the front panel for the Rad-87 horizontal instrument and the bottom of the front panel for the Rad-87 vertical device.
2 System Description R ad - 8 7 P u ls e C O - O x i me te r - Ho r i zo n t a l 2 1 3 4 5 7 6 8 9 10 11 DISPLAY DISPLAY APOD APOD APOD NORM NORM NORM MAX MAX MAX SENSITIVITY MODE SENSITIVITY SENSITIVITY SIQa 21 20 19 18 CONTROL / INDICATOR 2-2 1 Device Profile LED 2 Sensitivity Button/Indicator 3 LCD Display 17 16 12 RRa ENTER ENTER Rad-87 Rad-87 rbc monitor RI 15 14 13 12 DESCRIPTION The Device (instrument) Profile LED illuminates when the instrument has been set t
System Description CONTROL / INDICATOR 2 DESCRIPTION Off: No connection to Masimo Patient SafetyNet or other compatible interface system. 6 Wireless Indicator Flashing Green: Rad-87 attempts to connect to Patient SafetyNet or other compatible interface system. Solid Green: Rad-87 is connected to the Patient SafetyNet or other compatible interface system. 7 Used to enter the alarm menu to adjust Hi/Low SpO2, SpCO, SpMet, SpHb, PI, PVI, RRa and pulse rate alarm limits.
2 System Description CONTROL / INDICATOR 12 Used to enter the setup menus and to select/activate certain entries within the menu/setup system. Enter Button 13 Brightness Button 14 Up Button Down Button 15 DESCRIPTION Controls the level of the brightness for the LED display by providing 4 levels of brightness. Each press of the button increases the brightness one level. Once level 4 is accessed, an additional press of the button returns the brightness to level 1.
System Description 2 R ad- 8 7 P u ls e C O - O x i me te r - V er t i c a l 11 9 10 8 4 16 SIQa NORM 8 8978 8 8768 8 8128 RRa MAX 5 15 RI 7 13 2 19 12 3 6 18 14 17 11 21 20 Rad-87 Pulse CO-Oximeter Operator’s Manual 2-5
2 System Description R ad - 8 7 R e ar Pa ne l 1 2 3 4 Nurse Call Connector Use the 1/4” round Connector to interface with a nurse call system. This is a stereo output and should be utilized with a stereo cable. All external device connections to the Nurse Call Connector must be IEC60950 compliant. Serial Output Connector Use the Serial Output Connector to connect a serial device, including a serial printer, RadNet Interface Module, or PC, to the Rad-87.
System Description 2 Sym b o ls The following symbols may be found on the Rad-87 or packaging and are defined below: RS-232 Equipotential Ground Terminal Consult accompanying documents Nurse Call Interface WEEE compliant Mark of Conformity to European Medical Device Directive 93/42/EEC Rx Only Federal law restricts this instrument to sale by or on the order of a physician (USA audiences only) Year of manufacture Storage humidity range: 10% to 95% 5%-95% RH +70 C -40 C +1060 hPa - +500 hPa 795 mmHg -
2 System Description LCD D is p lay The LCD Display shows radio communication information when radio communication is active (wireless radio model only). It also shows system information. All Rad-87 models are equipped with an LCD display which is located on the top panel of a horizontal model, or on the left side panel of a vertical model. The LCD Display illuminates upon start up and displays the installed parameter/measurement's low and high alarm limits.
Setup 3 R ad- 8 7 S e t u p Introduction Before the Rad-87 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 Rad-87 battery needs to be fully charged. To charge the internal battery, connect the AC power cord to an AC outlet and to the Power Entry Module located on the back of the Rad-87. The AC Power Indicator illuminates. The AC Power Indicator will remain illuminated while the battery is charging. The Battery Charge Level Indicator will not be illuminated unless the instrument is operating on battery power. See Section 7-2, Specifications.
Setup 3 S yst e m In t e r f a c e S e tu p Philips VueLink Setup (Also refer to the Masimo SET VueLink Module and Serial Cable Directions for Use for additional details) 1. Select the Philips VueLink selection (PHL) from the Serial Output menu on the Rad-87. After selecting, choose the preferred settings by stepping through menu options. 2. Connect one end of the VueLink cable to the Serial Output connector on the back of the Rad-87. 3. Insert the VueLink module into the monitor rack. 4.
Operation 4 Intro d u ct io n To operate the Rad-87 system effectively, the instrument must be set up correctly and the operator must: ■ Know how the Rad-87 derives its readings (see Section 1). ■ Be familiar with its controls, components and operation. ■ Understand its status and alarm messages (see Section 5, Alarm and Messages and Section 6, Troubleshooting). Basi c O p e r at i on General Setup and Use 1. Inspect the Rad-87 case for damage. If damaged, refer to Section 9, Service and Repair. 2.
4 Operation Basic Operation, continued ■ PI Low Alarm Limit and PI High Alarm Limit ■ PVI Low Alarm Limit and PVI High Alarm Limit ■ Sensor Time remaining (if applicable). 9. On the LED and the LCD displays, verify the alarm limit settings (see Setup Menu Level 1, Parameter/Measurement Alarm Limits - Screen 1, Parameter/Measurement Alarm Limits - Screen 3 in this chapter). NOTE: “- - -” initially shows in the numeric display fields for all the parameters/measurements when the Rad-87 is turned on.
Operation 4 Basic Operation, continued ■ The System Status Light flashes red. ■ The display shows "SEN OFF" message. Disconnect the sensor from the patient cable or Rad-87. ■ The alarm tone sounds. ■ The Alarm Bell flashes red. ■ The System Status Light flashes red. ■ The display shows "NO SEN" message. NOTE: "NO SEN" or "SEN OFF" conditions will only generate a high priority alarm if the Rad87 is actively monitoring a patient when the sensor is disconnected. 12.
Operation 4 Basic Operation, continued Default Settings The Rad-87 Pulse CO-Oximeter stores two types of default values that the instrument automatically retains after a power cycle. 1. Factory defaults set by Masimo. 2. Default settings that can be changed by the user will be remembered after a power cycle.
Operation 4 Basic Operation, continued OPTION FACTORY DEFAULTS USER CONFIGURABLE DEFAULTS 60 Hz, 50 Hz 2, 4, 8, 10, 12, 14, 16 0, 10, 20, 30, 60 On/Off Setting is retained after power cycle Line Frequency SpO2 Averaging time RRa Averaging Time SmartTone FastSat 60 Hz 8 sec 30 Off Off RRa Sensor Status Notifications Off On/Off Device Profile settings N/A Blue, green, orange, pink or white SpHb Precision 0.1 0.1/ 0.
Operation 4 M as im o P u lse C O- O x i me tr y S en s o r s Before use, carefully read the Masimo sensor Directions for Use.Use only Masimo sensors for pulse oximetry or pulse CO-Oximetry measurements. Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor's Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor.
Operation 4 leading to patient harm. • Excessive ambient noise may affect the accuracy of the respiration rate reading from the Acoustic Respiration Sensor. Sensor Time Remaining Rad-87 instruments enabled with total hemoglobin (SpHb) and used with Masimo Rainbow reusable SpHb sensors will display the time remaining on the LCD Display. In addition to the display at the 4, 2, 1 hour and 0 minute marks, an audible tone will sound.
4 Operation Message Number LCD Message Cause 4 hours, 2 hours, 1 hour remaining Press and hold Display button for 5 seconds 3† Sensor ### Hrs SpHb sensor is connected after Rad-87 is powered on Condition 120 seconds Monitoring a patient 5 Sensor ### Min Replace sensor SpHb sensor is connected after Rad-87 is powered on SpHb sensor is applied to and/ or removed from the patient Sensor is nonfunctional Incompatible sensor 6 Incompatible sensor SpHb sensor attached to Rad-87 without SpHb install
4 Operation LED Light Emitting Diodes (LED) Display APOD APOD APOD NORM NORM NORM MAX MAX MAX SENSITIVITY MODE SENSITIVITY SENSITIVITY SIQa SeN Hrs 60 DISPLAY DISPLAY ENTER ENTER Rad-87 Rad-87 rbc monitor The Rad-87 LED displays messages to communicate the remaining sensor time available to the user, as defined in the following table: Message LED Number Message 1* 2 3† 4*† SEN nin 000 SEN HrS ### SEN nin ### Rpl SEN Cause SpHb sensor is non-functional SpHb sensor is connected after Ra
Operation 4 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 Numeric Display - SpMet A stable SpMet reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient’s measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the arterial oxygen saturation, blood concentration and perfusion. Inaccurate measurements may be caused by: ■ Intravascular dyes such as indocyanine green or methylene blue.
4 Operation Numeric Display - PVI The pleth variability index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percentage (0-100%). Low Perfusion The Rad-87 indicates perfusion on a 10-bar LED indicator.
Operation 4 Low SpHb When the signal quality for SpHb is very low the accuracy of the measurement may be compromised. In a low SpHb SIQ state, the parameter label will flash and either the SpHb value will be displayed or there will be dashes depending on how the user has configured this feature. Refer to the Factory Default and User Configurable Settings section for details. Signal Indication and Quality Indicator - Acoustic (SIQa) SIQa displays the confidence level of the measured signal.
Operation 4 Rainbow SET, Masimo SET Sensor Placement If the SpO2, SpCO, SpMet or SpHb readings are questionable or unavailable, do the following: ■ Make sure the emitter and detector are aligned directly opposite each other. ■ Select a site where the distance between the emitter and detector is minimized. ■ Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (10-30% methyl salicylate and 2-10% menthol) for 20-30 seconds to increase perfusion.
Operation 4 Sensitivity The Rad-87 Pulse CO-Oximeter is equipped with 3 different SpO2 sensitivity modes. Each mode allows the clinician to change the SpO2 sensitivity settings of the instrument to meet the increased demands of the patient’s physiological condition or enable it to work during periods of low perfusion and/or motion. They are as follows: ■ Normal Sensitivity (NORM) – This is the recommended mode for patients that are experiencing some compromise in blood flow or perfusion.
Operation 4 Low Battery Audible Alarm If a low battery condition occurs the audible alarm can be silenced until power cycle by pressing the Alarm Silence Button. Refer to Setup Menu Level 2 in this section to change setting. If a low battery condition occurs while not monitoring a patient, a low priority audible alarm will sound and can be silenced by pressing the Alarm Silence Button. The audible alarm is silenced until the power is cycled or patient monitoring begins.
Operation 4 Display Screens Showing RRa on Screen 1, SpHb on Screen 2 and PVI on Screen 3 SIQa 76 12 RRa RI SIQa 13 10.1 1.6 20 3 %SpCO SIQa Display Screens Showing PVI on Screen 1 and SpHb on Screen 2 SIQa 76 3 Screen 1 Home display screen SIQa 13 10.1 Screen 2 1.6 20 SIQa Screen 3 S e tu p M e n u This section gives an overview of the Rad-87 menu selections available.
4 Operation Se t u p M e n u Le v e l 1 Setup Menu Level 1 contains the parameters/measurements and settings that are adjusted most often for patient monitoring; alarm limits, display brightness, and sensitivity settings. Pressing the Display Button while viewing alarm limit settings allows the user to exit the Setup Menu and return to Screen 1.
Operation 4 Setup Menu Level 1, continued Parameter/Measurement Alarm Limits - Screen 2 To access alarm limits for parameters/measurements contained on Screen 2, press the Display Button to move from Screen 1 to Screen 2. From Screen 2, press the Alarm Limits Button to access the Alarm Limits menu for Screen 2 parameters/measurements. BUTTONS SETTINGS Press once PI LO Use the Alarm Limits Button to access the alarm limits options and move between options.
4 Operation Setup Menu Level 1, continued Parameter/Measurement Alarm Limits - Screen 3 To access alarm limits for parameters/measurements contained on Screen 3, press the Display Button two times to move from Screen 1 to Screen 3. Press the Alarm Limits Button from Screen 3 to access the Alarm Limits menu for Screen 3 parameters/measurements. BUTTONS SETTINGS Press once %SpMet LO Press 2x %SpMet HI Use the Alarm Limits Button to access the alarm limits options and move between options.
Operation 4 Setup Menu Level 1, continued SpO2 Sensitivity BUTTONS SETTING Press once APOD (Default) Use the SpO2 Sensitivity Button to access the sensitivity options and move between options. Press 2x NORM Press 3x Use the SpO2 Sensitivity Button to move between menu options and accept the setting. MAX (The MAX Indicator flashes in this mode.
4 Operation S e t u p M e n u Le v e l 2 Level 2 menu contains parameters and settings that are not changed as frequently as Level 1. These include alarm volume, alarm delay, clear trend and button volume parameters. Alarm Volume BUTTONS SETTINGS Level 3 (Default) Use the Enter Button to access the Alarm Volume menu and to move between Level 2 menus. Level 4 Use Up or Down Button to move between settings and the Enter Button to accept the setting and move to the next menu screen.
Operation 4 Setup Menu Level 2, continued RRa Alarm Delay The RRa alarm delay allows the user to adjust the time in which the audible status indicator will occur after a RRa alarm condition has been initiated. BUTTONS SETTINGS 0 10 seconds Press the Enter Button again to move to the next menu. 15 seconds 30 seconds 3x (Default) Use Up or Down Button to move between settings and the Enter Button to accept the setting and move to the next menu screen.
4 Operation Setup Menu Level 2, continued Button Volume BUTTON SETTING Level 2 (Default) Press the Enter Button again to move to the next menu. Level 1 Use Up or Down Button to move between settings and the Enter Button to accept the setting and move to the next menu screen. OR Off 5x press the Display Button to exit without saving the new setting and to return to the home display screen. Level 3 FastSat FastSat enables rapid tracking of arterial oxygen saturation changes.
Operation 4 Tren d S e t u p a n d U s e Introduction The Rad-87 can store up to 72 hours of trend data captured at 2 second intervals. The trend data can then be transferred to a PC for evaluation. A serial cable is required to connect the Rad-87 to a PC. Patient monitoring is not possible while trend memory is being transferred to a PC. Trend data is stored in non-volatile memory, so it is not erased when the instrument is shut off.
4 Operation Trend Setup and Use, continued C) Start the TrendCom Utility and Initiate Download 1. Turn on the Masimo Rad-87. 2. Make sure the Rad-87 is set to ASCII 2 Output mode. 3. Open the TrendCom Software on the PC. 4. Under the “Instrument” menu in TrendCom, select “Rad-87”. NOTE: TrendCom will display an “Invalid Data” message if the incorrect instrument is selected. 5. Under the “COM Port” menu, select the appropriate COM Port (ID number from Step B). 6. Click on “Retrieve Trend”. 7. Name the file.
Operation 4 S e tu p M e n u L e v e l 3 Enter Button + Down Button The Level 3 menu contains advanced parameter/measurement settings. To access Level 3 parameters/measurements, hold down the Enter Button and press the Down Button for 5 seconds. After entering menu Level 3, use the Enter Button to save new settings and move to the next menu. The user may cycle through the menu options by continuing to press the Enter Button.
Operation 4 Setup Menu Level 3, continued SpHb Averaging BUTTONS SETTINGS Short Use Up or Down Button to move between settings Press the Enter Button again to move to the next menu. Medium (Default) AND press the Enter Button to accept the setting and move to the next menu option. OR press the Display Button to exit without saving the new setting and to return to the home display screen. Long PVI Averaging BUTTONS Press the Enter Button again to move to the next menu.
Operation 4 Setup Menu Level 3, continued PI Averaging BUTTONS SETTINGS Press the Enter Button again to move to the next menu. Short Use Up or Down Button to move between settings Long AND press the Enter Button to accept the setting and move to the next menu option. OR (Default) press the Display Button to exit without saving the new setting and to return to the home display screen. RRa Averaging BUTTONS SETTINGS 0 Press the Enter Button again to move to the next menu.
Operation 4 Setup Menu Level 3, continued RRa Sensor Status Notifications BUTTONS SETTINGS Press the Enter Button again to move to the next menu. On Use Up or Down Button to move between settings Off AND press the Enter Button to accept the setting and move to the next menu option. OR (Default) press the Display Button to exit without saving the new setting and to return to the home display screen.
Operation 4 Setup Menu Level 3, continued Optical Sensor Off Audible Alarm Latch BUTTONS SETTING SEn Lch Press the Enter Button again to move to the next menu. Use Up or Down Button to move between settings AND On* press the Enter Button to accept the setting and move to the next menu. OR Off press the Display Button to exit without saving the new setting and to return to the home display screen.
4 Operation Setup Menu Level 3, continued Device Profile Setup and Use The Rad-87 can be configured to save changes to the instrument settings as a Device Profile. Using the Rad-87 button menu or an external configuration application, users can adjust Rad-87 settings and parameter/measurement alarm limits. After changing settings, the user may save the settings as a Device Profile.
Operation 4 Setup Menu Level 3, continued SmartTone On/Off The SmartTone feature uses a proprietary algorithm that will provide pulse tones during excessive motion and low perfusion conditions. The pulse tone is based on an averaged pulse rate measurement from the proprietary algorithm and may not identify irregular heart beat patterns when there is excessive artifact present.
4 Operation Setup Menu Level 3, continued Month BUTTONS SETTING Month Press the Enter Button again to move to the next menu Use Up or Down Button to adjust the setting. Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and move to the next menu. OR press the Display Button to exit without saving the new setting and to return to the home display screen. Day BUTTONS SETTING Day Press the Enter Button again to move to the next menu.
Operation 4 Setup Menu Level 3, continued Minute BUTTONS SETTING 30 minutes Press the Enter Button again to move to the next menu. (Default) Use Up or Down Button to adjust the setting. Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and move to the next menu. OR press the Display Button to exit without saving the new setting and to return to the home display screen.
Operation 4 Setup Menu Level 3, continued Interface Alarms When Rad-87 is interfaced to another system and the Interface Alarms are set to "Alarm Tones Off", all parameter audible alarms are muted at the Rad-87 and active at the interfaced system. This prevents both systems from producing audible alarms at the same time. NOTE: The Rad-87 reverts to Interface Alarms "Alarm Tones On" during power interruptions or when the interface connection is lost.
Operation 4 Setup Menu Level 3, continued Nurse Call Refer to Section 7, Nurse call specifications for additional information. BUTTONS SETTING Alarm (Default) Press the Enter Button again to move to the next menu option. Use Up or Down Button to move between settings AND Signal I.Q. press the Enter Button to accept the setting and move to the next menu option. OR Alarm and Signal I.Q. press the Display Button to exit without saving the new setting and to return to the home display screen.
4 Operation Setup Menu Level 3, continued Parameter/Measurement Select - Screen 1 BUTTONS SETTING RRa (if available) Use Up or Down Button to move between settings Press the Enter Button again to move to the next menu option. SpHb (if available) PVI (if available) AND press the Enter Button to accept the setting and move to the next menu option. OR press the Display Button to exit without saving the new setting and to return to the home display screen.
Operation 4 Setup Menu Level 3, continued Parameter/Measurement Select - Screen 3 BUTTONS SETTING RRa (if available) Press the Enter Button again to move to the next menu option. SpHb (if available) PVI (if available) (no parameter/ measurement displayed) Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and move to the next menu option. OR press the Display Button to exit without saving the new setting and to return to the home display screen.
4 Operation Setup Menu Level 3, continued LCD Language BUTTONS SETTING English Press the Enter Button again to move to the next menu option. (Default) Scrolls through available languages displayed on the LCD Use Up or Down Button to move between settings AND press the Enter Button to accept the setting and move to the next menu option. OR press the Display Button to exit without saving the new setting and to return to the home display screen.
Operation 4 Hom e M o d e O p e ra ti o n The Rad-87 can be placed into the Home Mode to protect unqualified users from changing the Rad-87 alarm settings and operation. Only the following menu and front panel functions are available: display brightness, pulse beep volume adjustment and alarm silence. Alarm volume is at highest setting. All default and user defined default settings are locked to their current values when home mode is selected and return to those values after a power cycle.
4 Operation LCD Display Function with Radio Configured and Enabled When the Radio feature is enabled (set to "On") and configured with the required network information, the LCD Display shows the following information for 20 seconds: 4-42 ■ Network Mode ■ Radio Mode ■ Channel ■ SSID ■ IP address ■ Subnet ■ Gateway ■ MAC Address ■ Encryption ■ Authentication ■ Destination IP ■ Destination Port ■ Signal Strength ■ Connected Access Point ■ Radio Diagnostics ■ Radio Error ■ Er
Alarms and Messages 5 Al ar m Id e n t if i c a ti o n The Rad-87 identifies alarms visually and audibly based on alarm conditions that the system detects. The 'system' includes the instrument, cables and sensors. Alarm conditions that occur depend upon the parameters monitored on the patient. Audible alarms will continue to sound until a valid parameter value is displayed on the instrument.
Alarms and Messages 5 Alarm Category Table, continued CATEGORY CHANNEL Optical ALARM Incompatible Sensor Replace Sensor Sen 000 Incompatible Adhesive Replace Adhesive Adh 000 Incompatible Cable Replace Cable Cbl 000 Interference Detected System Function Alarms Acoustic Instrument Error/Warning Alarms N/A RRa Sensor Status Notifications Acoustic Incompatible Sensor Replace Sensor Sen 000 Incompatible Cable Replace Cable Cbl 000 Err ## Low Battery No Sensor Interference Detected
Alarms and Messages 5 Alarm Limit: User Configurable Settings FACTORY DEFAULT RANGE INCREMENTS High SpO2 Limit "---" Off 2% - 99% 1% Low SpO2 Limit 90% 1% - 98% 1% High Pulse Rate Limit 140 BPM 35 BPM - 235 BPM 5 BPM Low Pulse Rate Limit 50 BPM 30 BPM - 230 BPM 5 BPM SETTING High SpCO Limit 10 2% - 98% 1% Low SpCO Limit "---" Off 1% - 97% 1% High SpMet Limit 3 1% - 99.5% Low SpMet Limit "---" Off 0.1% - 99% High SpHb Limit 17 2 g/dl - 24.
Alarms and Messages 5 Al ar m P r io r i t i e s The Rad-87 has three levels of alarm priority implemented: high, medium and low. The alarm priorities reflect how the instrument will behave when an alarm is present. The following table outlines instrument attributes within the alarm priorities.
Alarms and Messages 5 The Rad-87 offers the ability to monitor multiple 'channels' on a patient. The Rad-87 has an optical based channel and an acoustic based channel. The optical based channel provides SpO2, pulse rate, SpCO, SpMet, SpHb, SpOC, PI and PVI. The acoustic based channel provides respiration rate (RRa). When both the optical and acoustic channels are monitoring the patient together, the optical channel is considered 'primary' and the acoustic 'secondary'.
5 Alarms and Messages Audible alarms may be silenced, while visual alarms remain active. The alarm silence function is controlled by pressing the Alarm Silence button. The Alarm Bell and the System Status Light provide visual feedback when the Rad-87 audible alarms are silenced. When monitoring a patient with both the optical and acoustic channels present Action: Alarm event occurs; press Alarm Silence button once (audible alarms silenced for configured Alarm Silence period. Default is 120 seconds.
Alarms and Messages Action: State: 5 Removal of both patient cables/sensors Alarms active ALARM PRIORITY ALARM BELL SYSTEM STATUS LIGHT High Flashing Red Flashing Red Action: Press Alarm Silence button State: Alarms silenced ALARM PRIORITY ALARM BELL SYSTEM STATUS LIGHT Any Off Solid Yellow When not monitoring a patient Action: Press Alarm Silence button State: Alarms silenced ALARM PRIORITY ALARM BELL SYSTEM STATUS LIGHT Low Off Solid Yellow this State remains until active patient m
5 Alarms and Messages Alarm Mute When the Rad-87 is set to Interface Alarms "Alarm Tones Off" and an alarms condition occurs, the Alarm Bell flashes red and the System Status Light is solid yellow for low priority alarms, flashes yellow for medium priority alarms or flashes red for high priority alarms. The audible alarm activates at the interfaced system while the audible alarm is muted at the device.
Alarms and Messages 5 M e s s ag e s The Rad-87 Pulse CO-Oximeter will indicate other data or system errors. LED messages for the optical channel occupy the top two LED segments on the instrument. LED messages for the acoustic channel occupy the third LED segment. Message conditions for the Rad-87 follow: MESSAGE/DISPLAY POSSIBLE CAUSE(S) RECOMMENDATION(S) LCD: Replace Sensor LED: SEN SpHb reusable sensor is nonfunctional. Replace sensor. Sensor is non-functional. Emitter temperature out of range.
5 Alarms and Messages MESSAGE/DISPLAY POSSIBLE CAUSE(S) RECOMMENDATION(S) LCD: No Sensor No sensor connected. Connect sensor to patient. LCD: Check Sensor LED: CHc SEN Sensor is not connected firmly into patient cable or the instrument. Reconnect sensor firmly into patient cable, or to the instrument. LCD: No Adhesive Reconnect* LED: NO AdH* When using the Masimo Connect the ReSposable adhesive ReSposable Sensor System, the to the ReSposable reusable adhesive part is not connected. sensor.
Alarms and Messages MESSAGE/DISPLAY POSSIBLE CAUSE(S) 5 RECOMMENDATION(S) LCD: No Cable LED: No cable is connected. Reconnect cable. Incompatible or unrecognized cable. Connect appropriate cable to instrument. Improperly applied sensor. Reapply the sensor according to the sensor’s Directions for Use.
5 Alarms and Messages MESSAGE/DISPLAY 5-12 POSSIBLE CAUSE(S) RECOMMENDATION(S) Rule out occusion of blood flow. Attempt to warm patient. Move sensor to better perfused site. Bottom Two Segments of Perfusion Bar (PI) are Red Low Perfusion. Parameter/Measurement Label and Number Flash Alarm Limit Exceeded. Assess/address patient condition. Reset alarms limits, if indicated. Refer to Section 4 for instructions. Single Battery Level Indicator Flashes (With Audible Alarm) Battery level too low.
Troubleshooting 6 Troub le s h o o t i ng The following chart describes what to do if the Rad-87 system does not operate properly. PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION(S) Instrument does not power on Low battery/ not plugged into AC power supply. Connect the AC power cord to the Rad-87 and to an AC outlet. Make sure that the AC power indicator light is on. Battery run-time Is significantly reduced Low battery Contact Technical Services or your local Masimo representative.
Troubleshooting 6 PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION(S) Low confidence in RRa value (Last confident value displayed). May occur during patient activity (e.g. talking). Check for proper sensor placement. Low SIQa and flashing RRa parameter* Improperly applied sensor. Patient may have shallow breathing. Assess the patient. Low RI Reduce patient activity. Reduce excessive ambient or environmental noise. SpO2 values do not correlate with clinical assessment Or abgs.
Specifications 7 R ad- 8 7 S p e ci f i c a t i on s PERFORMANCE Measurement Range SpO2: SpMet: SpCO: SpHb SpOC Pulse Rate: RRa (Respiration Rate): SIQa Perfusion Index: Pleth Variability Index: Accuracy: Arterial Oxygen Saturation Accuracy1 Saturation No Motion Adults, Infants, Pediatrics Saturation No Motion2 Adults, Infants, Pediatrics Neonates* Motion3 Adults, Infants, Pediatrics, Neonates Low Perfusion4 Adults, Infants, Pediatrics, Neonates Pulse Rate Accuracy5 Pulse Rate: No Motion Adults, Infants,
7 Specifications Respiration Rate (RRa) Pulse Rate (bpm) 1 breath per minute 1 bpm * Only Rainbow sensors provide ± 2% for Neonates ELECTRICAL AC Power requirements: Power consumption: Batteries Type: Capacity (battery life)6: Rad-87 (stand-alone) Rad-87 with Rainbow Acoustic Monitoring Rad-87 with wireless radio and Rainbow Acoustic Monitoring Charging time: 100 - 240 VAC, 47-63 Hz 20 VA max.
Specifications 7 Display/Indicators Type: LED Display Language Data display: English (default) %SpO2, %SpCO, %SpMet, SpHb g/dl, SpOC ml/dl, pulse rate, pleth variability index (PVI), RRa, alarm status, status messages, Signal I.Q. (SIQ), acoustic Signal I.Q. (SIQa), perfusion index (PI),Respiration Indicator (RI), sensitivity modes, wireless radio connection, system status light.
7 Specifications S e r ial In t e r fa c e S p e c i f i c a t i on s The digital interface for serial communication is based on the standard RS-232 protocol. The Rad-87 Pulse CO-Oximeter by default always outputs ASCII 1 text data through the serial port, unless the user selects a different output mode in the Output menu. To interface with the Rad-87 and receive serial text data, simply connect a serial interface cable with a serial output connector located on the back of the Rad-87.
Specifications 7 N urs e Call S p e c i f i c a t i on s The nurse call features are accessible via the 1/4” round female connector on the back of the device. Nurse Call The nurse call feature on the Rad-87 Pulse CO-Oximeter is based on the relay closing or opening depending on alarm, Low Signal I.Q. events or both. In addition the nurse call polarity can be inverted to accommodate various nurse call stations requirements.
Sensors & Patient Cables 8 Intro d u ct io n 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 Rad-87 Pulse CO-Oximeter. Other transducers, sensors and cables may affect Rad-87's 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 M as im o Acou s t i c R e s p i r a t i on Sen s o r Acoustic Respiration Sensor, Acoustic Respiration Patient Cable and Dual Rainbow Cable The Acoustic Respiration Sensor and Rainbow acoustic cables are indicated for continuous, noninvasive monitoring of respiration rate (RRa) for adult patients, in hospitals, hospital-type facilities, mobile and home environments.
Sensors & Patient Cables 8 SpO2, SpMet, SpHb and pulse rate accuracy for the Rainbow sensors is specified in the following table. Rainbow Direct Connect sensors connect to the instrument directly.
8 Sensors & Patient Cables Rainbow ReSposable™ Pulse CO-Oximeter Sensor System SpO2, SpMet, SpHb and pulse rate accuracy for the Rainbow sensors is specified in the following table. The R2-25a must be used with a R2-25r and the R2-20a must be used with a R2-20r.
8 Sensors & Patient Cables LNOP® Reusable Sensors LNOP reusable sensors must be used in conjunction with PC or Red PC cables. Sensor Weight Range Saturation Accuracy No Motion Motion Pulse Rate Accuracy No Motion Motion Low Perfusion Accuracy Saturation Pulse Rate LNOP DCI > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm LNOP DCIP 10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm LNOP YI > 1 kg ± 2% ± 3% ± 3 bpm ± 5 bpm N/A N/A LNOP TC-I > 30 kg ± 3.5% N/A ± 3 bpm N/A ± 3.
8 Sensors & Patient Cables NOTE: The M-LNCS/LNCS TF-I and TC-I sensors were not validated under motion conditions. M-LNCS™/LNCS® Adhesive Sensors M-LNCS sensors must be used in conjuction with M-LNC or Rainbow patient cables or M-LNC adapter cables. LNCS sensors must be used in conjunction with LNC or Red LNC cables.
Sensors & Patient Cables 8 S e ns o r Accu r a c y Refer to Section 7, Specifications for SpO2, SpMet, SpCO, SpHb, RRa and pulse rate accuracy unless otherwise specified in the previous tables: Complete accuracy specifications are located in the sensor's Directions For Use and are specific for the type of Masimo sensor used. Cl ean in g An d R e u s e O f M a s i m o Reu s a b l e S e ns o r s an d C a bl e s Reusable sensors and patient cables can be cleaned per the following procedure: 1.
Service & Maintenance 9 Intro d u ct io n This chapter covers how to test the operation, properly clean and how to obtain service for the Rad-87 Pulse CO-Oximeter. 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 Service WARNING: THE BATTERY SHOULD BE INSTALLED AND/ OR REMOVED FROM THE RAD-87 BY QUALIFIED PERSONNEL ONLY. P e r f o r m an ce V e r i f i c a ti o n To test the performance of the Rad-87 after repairs or during routine maintenance, follow the procedure outlined in this section. If the Rad-87 fails any of the described tests, discontinue its use and correct the problem before returning the instrument back to the user.
Service & Maintenance 9 Testing the Rad-87 with Masimo Set Tester (Optional): 1. Turn the Rad-87 off and then on again. 2. Connect the Masimo SET Tester to the Pulse CO-Oximeter Patient Cable Connector. 3. Verify that within 20 seconds all available pulse bars display. 4. Verify that the SpO2 measurement is between 79% and 84%. 5. Verify that the pulse rate measurement is between 55 bpm and 65 bpm. 6.
9 Service & Maintenance WARNING: AN OPERATOR MAY ONLY PERFORM MAINTENANCE PROCEDURES SPECIFICALLY DESCRIBED IN THIS MANUAL. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL TRAINED IN THE REPAIR OF THIS EQUIPMENT. Please clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Section 9, Cleaning. Make sure the equipment is fully dry before packing. To return the Rad-87 Pulse CO-Oximeter for service, please follow the Return Procedure.
Service & Maintenance 9 S al es & E n d - U s e r Li c e n s e A g r e em en t 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.
9 Service & Maintenance NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT CANNOT LEGALLY BE DISCLAIMED BY CONTRACT. End-User License 9-6 1.
Service & Maintenance 9 Re st r ict io n s 1. Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden. Purchaser may be held legally responsible for any copyright infringement that is caused or incurred by Purchaser’s failure to abide by the terms of this Agreement.
Section 10 Part Numbers Part Numbers 10 P art Nu m b e r s PART NUMBER 34156 34157 34158 34159 34165 34160 34162 34161 34163 34164 DESCRIPTION Rad-87 Operator's Manual (SpHb), French Rad-87 Operator's Manual (SpHb), German Rad-87 Operator's Manual (SpHb), Italian Rad-87 Operator's Manual (SpHb), Spanish Rad-87 Operator's Manual (SpHb), Japanese Rad-87 Operator's Manual (SpHb), Dutch Rad-87 Operator's Manual (SpHb), Portuguese Rad-87 Operator's Manual (SpHb), Danish Rad-87 Operator's Manual (SpHb), Swed
33611/5727K-1210 www.masimo.com Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo.
