Rad-57 Pulse CO-Oximeter Operator's Manual PDF

1 overview overview 1 INDICATIONS FOR USE...

1 overview overview 1 INDICATIONS FOR USE Pulse CO-Oximetry The Rad-57 and accessories are indicated for the continuous, noninvasive monitoring of SpO2 GENERAL DESCRIPTION functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor)* and methemoglobin saturation Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial (measured by a SpCO/SpMet sensor)*. The Rad-57 and accessories are indicated for use oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, with adult, pediatric and neonatal patients during both motion and no motion conditions, usually on the fingertip for adults, and the hand or foot for neonates. The sensor connects and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile to the pulse oximetry instrument with a patient cable. The sensor collects signal data from and home environments. the patient and sends it to the instrument. The instrument displays the calculated data in two ways: 1) As a percent value for arterial oxygen saturation (SpO2) *See Model Summary for applicable unit. 2) As a pulse rate (PR) The following figure shows the general monitoring setup. 3 1. Instrument 2. Sensor 3. Patient Cable 1 2 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 Rad-57c and Rad-57cm display 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 Rad-57m and Rad-57cm display the calculated data as percentage value for the SpMet. 1-4 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 1-5  1 overview overview 1 PRINCIPLE OF OPERATION FUNCTIONAL VS. FRACTIONAL SATURATION Pulse oximetry is governed by the following principles: The Rad-57 is calibrated to measure and display functional saturation (SpO2): the amount 1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to carboxyhemoglobin (blood with carbon monoxide content) and methemoglobin transport oxygen. Note that carboxyhemoglobin is not capable of transporting oxygen, but (blood with oxidized hemoglobin content) species differ in their absorption of visible is recognized as oxygenated hemoglobin by conventional pulse oximetry. and infrared light (using spectrophotometry, see figure below). MEASURED VS. CALCULATED VALUES 8 Carboxyhemoglobin Oxyhemoglobin SpO2, SpCO* and SpMet* measurements that can be obtained from the Rad-57 are 6 Methemoglobin commonly compared to invasive measurements obtained from blood gas samples. When Absorption (mm-1) Deoxyhemoglobin comparing invasive and noninvasive measurements and interpreting values, caution 4 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 2 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 0 600 650 700 750 800 850 900 950 1000 shift the relationship between the partial pressure of oxygen (PO2) and saturation, such Wavelength (nm) as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal 2. The amount of arterial blood in tissue changes with your pulse (photoplethysography). hemoglobin. In the case of SpCO and SpMet, in addition to the effects of temperature and Therefore, the amount of light absorbed by the varying quantities of arterial blood pH, different results are also expected if concentration of methemoglobin in the blood gas changes as well. sample are abnormal (less than 90% for arterial oxygen saturation, and greater than 2% The Rad-57 Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between for methemoglobin concentration). As blood gas samples are usually taken over a period oxygenated blood, deoxygenated blood, blood with carbon monoxide content and blood of 20 seconds (the time it takes to draw the blood) a meaningful comparison can only be with oxidized hemoglobin. The Rad-57 utilizes a sensor with various light-emitting diodes achieved if the oxygen saturation, carboxyhemoglobin and methemoglobin concentration of (LEDs) that pass light through the site to a photodiode (photodetector). See figure below. the patient are stable and not changing over the period of time that the blood gas sample Signal data is obtained by passing various visible and infrared lights (LED’s, 500 to 1000nm) is taken. through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in MASIMO SET SIGNAL EXTRACTION TECHNOLOGY FOR SpO2 MEASUREMENTS 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 Masimo Signal Extraction Technology’s signal processing differs from conventional receives the light, converts it into an electronic signal and sends it to the Rad-57 for pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only calculation. 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, 1 because they cannot distinguish between the arterial and venous blood movement 1. Light Emitting Diodes (LEDs) (sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and (7 + wavelengths) adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the 2. Recessed Photo Detector varying physiologic signals and/or noise and separate them by looking at the whole signal 2 and breaking it down to its fundamental components. The Masimo SET signal processing Once the Rad-57 receives the signal from the sensor, it utilizes Masimo Rainbow SET algorithm, Discrete Saturation Transform® (DST)®, reliably identifies the noise, isolates it signal extraction technology to calculate the patient’s functional oxygen saturation, blood and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for levels of carboxyhemoglobin (SpCO*), methemoglobin (SpMet*) and pulse rate. The SpCO display on the monitor. and SpMet measurements rely on a multiwavelength calibration equation to quantify the SpCO AND SpMet MEASUREMENTS DURING PATIENT MOTION percentage of carbon monoxide and methemoglobin in arterial blood. The maximum of The Rad-57 displays measurements of SpCO* and SpMet* during patient motion. However, the skin surface temperature is measured at an ambient temperature of less than 106º F because of the changes in the physiological parameters such as blood volume, arterial- (41º C). This is verified by Masimo sensor skin temperature test procedures. venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be readable during excessive motion. * See Model Summary for applicable unit. * See Model Summary for applicable unit. 1-6 Rad-57cm Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 1-7  1 overview system description 2 MASIMO RAINBOW SET PARALLEL ENGINES Introduction This figure is for conceptual purposes only. The Rad-57 is a full featured Pulse CO-Oximeter designed for ease of operation. All pulse R/IR Intermediate Calculations (Conventional oximetry measurement information, as well as device status data, is displayed on the front Confidence Pulse Oximetry) panel of the device. All user input is handled by control buttons on the front panel and the DST ® Intermediate Calculations sensor cable connection is located at the top edge of the device. LED Adaptive Wavelengths Filter Confidence The Rad-57 is powered by 4 “AA” alkaline batteries, which provides a minimum of 8 hours of battery life. Intermediate Calculations SST ™ Confidence Confidence Post Rad-57 offers full Masimo Rainbow SET Technology in a small, hand held device. Pre-Processing & Based Processor Data Reduction FST: Intermediate Calculations Arbitrator Rad-57 supports the full line of Masimo sensors (see Section 8, sensors and Proprietary Confidence Digitized, Filtered & Algorithm 3 patient cables). Normalized FST: Intermediate Calculations Provides 72 hours of trending memory Proprietary Confidence Algorithm 4 %SpO2 Rainbow Intermediate Calculations %SpCO A Direct Connect Rainbow reusable sensor or patient cable or a Direct Connect Red Specific Confidence reusable sensor or patient cable attaches to the patient cable connector on the top of the Algorithms %SpMet Rad-57 unit. The Rad-57 can be used either as a transport monitor or as a handheld Pulse Intermediate Calculations PI CO-Oximeter for spot checks. Pulse Rate Confidence PR Algorithm MASIMO SET DST® 1-8 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-1  2 system description system description 2 Rad-57c Front Panel Controls DESCRIPTION CONTROL / INDICATOR 1 Pressing this button will display the numeric SpCO value in place of the SpO2 numeric value and CO in the place of 6 Display Button pulse rate. Pressing this button again will return to the SpO2 2 11 /pulse rate numeric value. rainbow 7 Used to enter the setup menus and to select/activate certain 3 Signal Extraction Pulse CO-Oximeter Mode / Enter Button SpCO 12 entries within the menu/setup system. >40 >5 4 35 30 %SpCO %SpO2 3 2 Used within the menu/setup system to move through setup 25 1.75 13 8 Next Button 20 15 12 1.5 1.25 1 options. Not active during normal patient monitoring. 5 9 6.5.25 40. select values within each menu option. Provides audible indication of alarm conditions, pulse tone The pulse rate in beats per minute (bpm). When searching for and feedback for key-presses. Ensure the speaker is not 5 Pulse Rate Display 18 Speaker a saturation and pulse, it will flash dashed lines. covered or the unit is placed face-down on bedding or other sound absorbing surface. 2-2 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-3  2 system description system description 2 Rad-57m Front Panel Controls DESCRIPTION CONTROL / INDICATOR 1 Pressing this button will display the numeric SpMet value 6 Display Button in place of the pulse rate numeric value until the SpMet button is pressed again. 2 11 Used to enter the setup menus and to select/activate 7 Mode / Enter Button certain entries within the menu/setup system. rainbow 3 Signal Extraction Pulse CO-Oximeter 12 SpMet Used within the menu/setup system to move through setup 4 >20 15 >5 3 8 Next Button 10 7.5 %SpO2 1.75 2 options. Not active during normal patient monitoring. 5 4 3 1.5 1.25 1 13 5 2 1.5.25 Press to turn the unit on..5 %SpMet %SpMet BPM PI 5% (strong perfusion). The highest LED will Rad-57m 13 PI remain lit continuously to allow a PI level to be viewed. The Perfusion Index is the ratio of the AC (pulsatile) to DC (non- CONTROL / INDICATOR DESCRIPTION pulsatile) components of the IR (Infrared) signal where the Connects to a Rainbow Sensor or Rainbow Patient Cable, AC and DC components correspond to the pulsatile and Patient Cable non-pulsatile amounts of blood, respectively. 1 Red Sensor or a Red Patient Cable with an LNOP, LNOPv Connector or LNCS Sensor. Flashes to indicate low SpO2 Signal IQ. Refer to Section 14 Low SIQ Slow flashing indicator: The confidence in the SpMet value 4, Low Signal IQ. obtained is low. 2 SpMet indicator Flashes to indicate the alarm is temporarily silenced. Fast flashing indicator: Flashes when an SpMet alarm 15 A solid illuminated light indicates that the alarms are Alarm Silenced Indicator condition exists. permanently silenced until the power is cycled or the alarms are enabled per Setup Menu 1 in Section 4. The functional arterial hemoglobin oxygen saturation is Push once to temporarily silence the alarm for 120 Saturation (%SpO2) 3 displayed in units of SpO2. When searching for a saturation 16 Alarm Silence Button seconds. Push a second time to return the unit to standard Display and pulse, it will flash dashed lines. alarm monitoring. Illuminates when SpMet capable sensor is attached. Bar will During saturation monitoring, use these buttons to adjust flash for SpMet alarm conditions. Continuously indicates the Up button the volume of the pulse beep tone. 4 %SpMet Bar 17 concentration of Methemoglobin in increments:.5, 1-5, 7.5, Down button Within the menu/setup system, these buttons are used to 10, 15 >20%. select values within each menu option. Indicator above label will illuminate to provide an additional Provides audible indication of alarm conditions, pulse tone visual indication of the SpMet value currently being and feedback for key-presses. Ensure the speaker is not %SpMet / Pulse Rate displayed. 18 Speaker 5 covered or the unit is placed face-down on bedding or Display The pulse rate in beats per minute (bpm). When searching other sound absorbing surface. for a saturation and pulse, it will flash dashed lines. 2-4 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-5  2 system description system description 2 Rad-57cm Front Panel Controls CONTROL / INDICATOR DESCRIPTION 1 Pressing this button will display the numeric SpCO value in place of the SpO2 numeric value and the SpMet value in 2 place of the pulse rate. Pressing this button again will display 6 Display Button 11 " PI " in place of SpCO and the PI numeric value in place of rainbow the SpMet value. Pressing this button again will return to the 3 Signal Extraction Pulse CO-Oximeter 12 SpO2 and pulse rate numeric values. Low PI 4 >40 35 >20 15 Used to enter the setup menus and to select/activate certain 30 25 %SpCO %SpO2 10 7.5 7 Mode / Enter Button 20 15 12 5 4 3 13 entries within the menu/setup system. 5 9 6 2 1 20%. Patient Cable 1 Red Sensor or a Red Patient Cable with an LNOP, LNOPv Connector Indicator above label will illuminate to provide an additional or LNCS Sensor. 14 %SpMet/BPM visual indication of the value currently being displayed. The Perfusion Index (PI) LED illuminates a constant light 2 Low PI Indicator Flashes to indicate low SpO2 Signal IQ. Refer to Section 4, when aterial pulsations are very low (weak perfusions). 15 Low SIQ Low Signal IQ. Saturation The functional arterial hemoglobin oxygen saturation is Flashes to indicate the alarm is temporarily silenced. (%SpO2) and displayed in units of SpO2. When searching for a saturation Alarm Silenced A solid illuminated light indicates that the alarms are 3 16 Carboxyhemoglobin and pulse, it will flash dashed lines. Indicator permanently silenced until the power is cycled or the alarms are enabled per Setup Menu 1 in Section 4. (%SpCO) Displays See SpCO/SpMet Button description, below. Push once to temporarily silence the alarm for 120 seconds. Illuminates when SpCO capable sensor is attached. Bar will 17 Alarm Silence Button Push a second time to return the unit to standard alarm flash for SpCO alarm conditions. Continuously indicates the monitoring. 4 %SpCO Bar concentration of carboxyhemoglobin in increments of: 3, 6, During saturation monitoring, use these buttons to adjust the 9, 12, 15, 20, 25, 30, 35, > 40. Up button volume of the pulse beep tone. The pulse rate in beats per minute (bpm). When searching 18 Pulse Rate Display Down button Within the menu/setup system, these buttons are used to 5 and Methemoglobin for a saturation and pulse, it will flash dashed lines. select values within each menu option. (%SpMet) Displays See Display button description. Provides audible indication of alarm conditions, pulse tone and feedback for key-presses. Ensure the speaker is not 19 Speaker covered or the unit is placed face-down on bedding or other sound absorbing surface. 2-6 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-7  2 system description system description 2 Rad-57 Rear Panel (all models) SYMBOLS The following symbols are found on the back of the Rad-57 Signal Pulse CO-Oximeter or packaging and are defined below: SYMBOL DESCRIPTION Caution, consult accompanying documents Type BF applied part complying with IEC 60601-1 Masimo Corporation Irvine, CA 92618 USA Rx Only Rad-57 80 FK Masimo Corporation Irvine, CA 92618 USA Rx Only Rad-57 80 FK WEEE Compliant UL 60601-1 UL 60601-1 Masimo, SET, , and SIQ are registered trademarks of Masimo Corporation. Masimo, SET, , and SIQ are registered trademarks of Masimo Corporation. Rad-57 is a trademark of Masimo Corporation. Rainbow and SpCO are Rad-57 is a trademark of Masimo Corporation. Rainbow and SpCO are registered trademarks of Masimo Laboratories. Signal Extraction Pulse registered trademarks of Masimo Laboratories. Signal Extraction Pulse CO-Oximeter and SpMet are trademarks of Masimo Laboratories. CO-Oximeter and SpMet are trademarks of Masimo Laboratories. 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 Rx ONLY (USA audiences only) Underwriter's Laboratories Inc. approved 5%-95% RH Storage humidity range: 5% to 95% +70 C Storage temperature range: +70˚C to -40˚C Storage altitude range: +1600hPa to +500hPa -40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg CONTROL / INDICATOR DESCRIPTION Keep dry 1 Serial Number Label Located on outside of case Fragile/breakable, handle with care 2 Agency Approvals Label Located on outside of case 3 Battery Cover Located on back of unit Year of Manufacture Press down and slide the battery cover off the bottom of 4 Battery Cover Release the oximeter 2-8 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-9 setup 3 Introduction Before the Rad-57 Pulse CO-Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be installed. Unpacking and inspection Remove the instrument from the shipping carton and examine 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 The following sections of the manual describe the preparation, set-up and initial installation of the Rad-57 Pulse CO-Oximeter. POWER REQUIREMENTS The Rad-57 is powered by 4 “AA” alkaline batteries. Do not use any other type of batteries or power source to run the device. The battery compartment is accessed from the back of the device. To install the batteries first remove the battery cover by depressing the small rectangular button at the bottom of the cover, and sliding the cover down off the bottom of the device. Install the batteries in the directions indicated by the battery icons inside the battery compartment. Replace the battery cover by sliding it back up from the bottom of the device until the rectangular locking button snaps back into position. WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BATTERIES MAY AFFECT THE ACCURACY OF THE BATTERY LEVEL METER. WARNING: USE OF BATTERIES WITH A CELL VOLTAGE OF MORE THAN 1.5V COULD CAUSE DAMAGE TO THE RAD-57. Battery charge level is indicated by four LED indicators at the bottom of the front panel. All four indicators will be lit when the batteries are full, with fewer indicators being lit as the batteries lose their charge. When less than ten (10) percent battery life remains, the final battery indicator will begin to flash and an audible alarm will sound. Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 3-1  3 setup operation 4 Monitor Setup Introduction To operate the Rad-57 Pulse CO-Oximeter effectively, the operator must: INITIAL SETUP Know how the oximeter derives its readings (see Section 1, Pulse CO-Oximetry) 1. Inspect the oximeter case for damage. Be familiar with its controls and operation. 2. Install 4 (four) new AA alkaline batteries. Understand its status and alarm messages (see Section 5, Alarm Identification, 3. Turn the unit on, the LEDs will scroll in the display window as the sensor calibrates, System Messages and Section 6, Troubleshooting). verify all indicators illuminate and speaker sounds a brief tone. Basic Operation 4. Configure the unit for your regional power line frequency (50 or 60 hz) if needed. GENERAL SETUP AND USE Default is 60 hz (standard for the United States). See Section 4, Special Menu, Special menu - Line Frequency Configuration. 1. Inspect the oximeter case for damage. 2. Ensure that the batteries are correctly installed. 3. Connect a Rainbow Sensor or a Red Patient Cable with an LNOP, LNOPv or LNCS CAUTION: THE UNIT MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER LINE sensor to the Patient Cable connector of the oximeter. Make sure it is a secure FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED BY connection and the cable is not twisted, sliced or frayed. See Section 5, Messages, FLUORESCENT LIGHTS AND OTHER SOURCES. to view messages that may be displayed pertaining to sensors and cables. 4. Select a sensor that is compatible with the oximeter before connecting it to the patient No other setup is required. Refer to Section 4, General Setup and Use for additional steps cable. See Section 8, Sensors and Patient Cables. If using a single patient adhesive to verify proper functioning of the unit. or disposable sensor, check that the emitter (red light) and the photodetector are properly aligned. If using a reusable sensor, make sure it opens and closes smoothly. Remove any substances that may interfere with the transmission of light between the sensor’s light source and photodetector. 5. Attach the sensor to the patient. Refer to the Directions for Use of the sensor. 6. Properly align and insert the male-connector end of the sensor into the female- connector end of unit (or patient cable). Make sure it is a secure connection. 7. Press the Power button to turn the oximeter on. 8. Verify all front-panel indicators momentarily illuminate and an audible tone is heard. 9. Verify the front panel display is free of alarm and system failure messages (see Section 5, Alarms and Messages) and the battery indicator shows sufficient charge (see Section 4, Battery Level Indicator). 10. Verify that the display shows the current device settings in the following order: SpO2 Low Alarm Limit SpO2 High Alarm Limit Pulse Rate Low Alarm Limit Pulse Rate High Alarm Limit SpCO Low Alarm Limit* SpCO High Alarm Limit* SpMet Low Alarm Limit* SpMet High Alarm Limit* Sensitivity Averaging Time FastSat: On or Off *See Model Summary for applicable unit. 3-2 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-1  4 operation operation 4 11. On the display, for each corresponding parameter and applicable unit, verify DEFAULT SETTINGS the readings for SpO2, SpCO, SpMet and pulse rate (See Model Summary for The Rad-57 is shipped configured with all values set to factory default. Adjustments made applicable unit). by the user will be retained after a power cycle for all values except alarm silence. NOTE: “- - - “ will flash on the numeric display until the SpO2, SpCO, SpMet and NOTE: Before use, confirm that the device settings are set appropriately. pulse rate readings have stabilized (less than 20 seconds for SpO2 and up to 25 sec- onds for SpCO and SpMet). The following table outlines the default values and the values the Rad-57 reverts to after a power cycle: 12. Verify that the patient alarms are functional by setting the high and low SpO2 and pulse rate alarm limits beyond the patient readings. CONFIGURABLE SETTING/ OPTION FACTORY DEFAULT SETTING BEHAVIOR AT POWER-UP An alarm tone sounds. SpO2 high alarm limit (Default is OFF) Set to Pre-Power Down Setting The violated alarm parameter flashes. See Section 5, Alarm Limits for 13. Verify the sensor alarms are functional by removing the sensor from the sensor site. SpO2 low alarm limit (Default is 90%) all settings. “SEn OFF” message appears on the display. Pulse rate high alarm limit (Default is 140 BPM) Set to Pre-Power Down Setting The alarm tone sounds. See Section 5, Alarm Limits for Pulse rate low alarm limit (Default is 50 BPM) all settings. The Visual Alarm Indicator flashes. SpCO* high alarm limit (Default is 10%) Set to Pre-Power Down Setting Disconnect the sensor from the patient cable or oximeter. See Section 5, Alarm Limits for Confirm that “NO SEn” message appears on the display. SpCO* low alarm limit (Default is OFF) all settings. NOTE: “NO SEn” and “SEn OFF” will only generate an alarm if the Rad-57 was SpMet* high alarm limit (Default is 3%) Set to Pre-Power Down Setting actively monitoring a patient when the sensor was disconnected. See Section 5, Alarm Limits for SpMet* low alarm limit (Default is OFF) all settings. 14. Verify parameter violation alarm silence operation. Set to Pre-Power Down Setting Create an alarm condition by lowering the SpO2 or pulse rate high alarm Averaging Time (Default is 8 seconds) limits beyond the patient readings. 2, 4, 8, 10, 12, 14, or 16 seconds Set to Pre-Power Down Setting Press the Alarm Silence button. FastSat (Default is OFF) Off/On The alarm tone ceases for 120 seconds. Set to Pre-Power Down Setting Sensitivity (Default is Normal) 15. To begin patient monitoring: Normal, MAX or APOD Set to Pre-Power Down Setting Adjust the alarm limits. Display brightness (Default is level 2) Levels 1 through 4 Adjust the alarm volume. Set to Pre-Power Down Setting Pulse tone volume (Default is level 4) Adjust the pulse beep volume. Levels 1 through 7 Set to Pre-Power Down Setting 16. Verify the sensor is applied correctly and that the measured data is appropriate, see Alarm Volume (Default is level 1) Section 4, Successful SpO2 Monitoring. Levels 1 through 4 Set to Pre-Power Down Setting 17. Monitor the patient. Line Frequency (Default is 60 Hz) 50 Hz/ 60 Hz 18. After monitoring is complete, remove the sensor from the patient and store or Set to Pre-Power Down Setting dispose of the sensor according to governing rules. See the Directions for Use of Trend Active (Default is ON) Off/On the sensor. Set to All Alarms Active Alarm Silence (Default is All Alarms Active) 19. Press and hold the Power On/Off button for 2 seconds to turn the oximeter off. Alarm on/off *For each corresponding parameter, refer to the applicable unit. 4-2 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-3  4 operation operation 4 Successful SpO2 Monitoring NUMERIC DISPLAY - PULSE RATE The following general points will aid in ensuring oximetry monitoring success. The Pulse Rate displayed on the Rad-57 may differ slightly from the heart rate displayed Place the sensor on a site that is not too thick, has sufficient perfusion and provides on ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation. Significant differences proper alignment of the LED’s and photodetector. may indicate a problem with the Signal IQ due to physiological changes in the patient or Place the sensor on a site that has unrestricted blood flow. one of the instruments or application of the sensor or patient cable. The pulsations from Do not secure a sensor with tape. intra-aortic balloon support can be additive to the pulse rate displayed on the Pulse CO- Do not select a site near potential electrical interference (electrosurgical unit, for Oximeter. example). NUMERIC DISPLAY - SpCO (for applicable models) Read the sensor Directions for Use for proper sensor application. A stable SpCO reading is associated with correct sensor placement, small physiological MASIMO SENSORS changes during the measurement and acceptable levels of arterial perfusion at the measurement site. Physiological changes at the measurement site are mainly caused by Before use, carefully read the LNOP, LNOPv, LNCS and Rainbow series sensor Directions fluctuations in the oxygen saturation, blood concentration and perfusion. for Use. Use only Masimo oximetry sensors for SpO2 measurements. Inaccurate measurements may be caused by: Tissue damage can be caused by incorrect application or use of an LNOP, LNOPv, LNCS Significant levels of methemoglobin. or Rainbow sensor, for example by wrapping the sensor too tightly. Inspect the sensor site Intravascular dyes such as indocyanine green or methylene blue. as directed in the sensor Directions for Use to ensure skin integrity and correct positioning Abnormal hemoglobin levels. and adhesion of the sensor. Abnormally low arterial perfusion. CAUTIONS DO NOT USE DAMAGED LNOP, LNOPv, LNCS OR RAINBOW SENSORS. DO NOT NUMERIC DISPLAY - SpMet (for applicable models) USE AN LNOP, LNOPv, LNCS OR RAINBOW SENSOR WITH EXPOSED OPTICAL A stable SpMet reading is associated with correct sensor placement, small physiological OR ELECTRICAL COMPONENTS. DO NOT IMMERSE THE SENSOR IN WATER, changes during the measurement and acceptable levels of arterial perfusion at the SOLVENTS, OR CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS measurement site. Physiological changes at the measurement site are mainly caused by ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, fluctuations in the oxygen saturation, blood concentration and perfusion. AUTOCLAVE OR ETHYLENE OXIDE (UNLESS OTHERWISE INDICATED ON THE SENSOR DIRECTIONS FOR USE). SEE THE CLEANING INSTRUCTIONS IN Inaccurate measurements may be caused by: THE DIRECTIONS FOR USE FOR REUSABLE MASIMO LNOP, LNOPv, LNCS OR Intravascular dyes such as indocyanine green or methylene blue. RAINBOW SENSORS. Abnormal arterial perfusion DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT CABLES IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT CABLE CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY NUMERIC DISPLAY - PI (for applicable models) IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE. The Perfusion Index (PI) display provides a relative numeric indication of the pulse strength DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE MASIMO at the monitoring site. It is a calculated percentage between the pulsatile signal and SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE nonpulsatile signal of arterial blood moving through the site. PI may be used to find the best ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO PATIENT HARM. perfused site and to monitor physiological changes in the patient. It displays an operating range of <.1 percent to > 5 percent on the Rad-57c and Rad-57m and 0.1 percent to 20.0 NUMERIC DISPLAY - SpO2 percent on the Rad-57cm. A percentage greater than 1.00 percent is desired. Extreme Stability of the SpO2 readings may be a good indicator of signal validity. Although stability changes in the display number are due to changes in physiology and blood flow. is a relative term, experience will provide a good feeling for changes that are artifactual or LOW SIGNAL IQ (LOW SIQ) 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 Rad-57 display provides a visual indicator Signal IQ and an alert when the displayed the more stable the readings tend to become. This is due to a dampened response as SpO2 values are not based on adequate Signal IQ. The Signal IQ indicator is displayed on the signal is averaged over a longer period of time than during shorter averaging times. the Rad-57 as “Low SIQ”. However, longer averaging times delay the response of the oximeter and reduce the measured variations of SpO2 and PR. 4-4 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-5  4 operation operation 4 The Low SIQ indicator flashes when the SpO2 measurement may be compromised. When SENSITIVITY the Low SIQ indicator is flashing, proceed with caution and do the following: Three sensitivity levels enables a clinician to tailor the response of the Rad-57 to the needs Assess the patient. of the particular patient situation. They are as follows: Check the sensor and ensure proper sensor application. The sensor must be well Normal Sensitivity – This is the recommended mode for typical monitoring secured to the site for the Rad-57 to maintain accurate readings. Also, misalignment purposes. It is advisable for care areas where patients are observed frequently, of the sensor’s emitter and detector can result in smaller signals. such as ICU’s. Determine if an extreme change in the patient’s physiology and blood flow at the Adaptive Probe Off Detection (APOD™) – This is the recommended monitoring monitoring site occurred, (e.g. an inflated blood pressure cuff, a squeezing motion, mode where there is a high probability of the sensor becoming detached. It is sampling of an arterial blood specimen from the hand containing the pulse oximetry also the suggested mode for care areas where patients are not visually monitored sensor, severe hypotension, peripheral vasoconstriction in response to hypothermia, continuously. This mode delivers enhanced protection against erroneous pulse medications, or a spell of Raynaud’s syndrome.) rate and arterial oxygen saturation readings when a sensor becomes inadvertently With neonates or infants, check that the peripheral blood flow to the sensor site has detached from a patient due to excessive movement. not been interrupted. For example, as may occur while lifting or crossing their legs during a diaper change. Maximum Sensitivity (MAX) - This mode is recommended for patients with low perfusion or when the low perfusion message is displayed on the screen in APOD After performing the above, if the “Low SIQ” indication occurs frequently or continuously, or normal sensitivity mode. This mode is not recommended for care areas where obtaining an arterial blood specimen for CO-Oximetry analysis may be considered to verify patients are not monitored visually, such as general wards. It is designed to the oxygen saturation value. interpret and display data at the measuring site when the signal may be weak due to decreased perfusion. When a sensor becomes detached from a patient, it will LOW PERFUSION have compromised protection against erroneous pulse rate and arterial saturation Low Perfusion is indicated when the arterial pulsations are very low (weak perfusion). Low readings Perfusion is shown when the PI LED indicator bar does not exceed 0.25 on the Rad-57c and Rad-57m. Low Perfusion on the Rad-57cm is shown when the Low PI LED indicator CAUTION: WHEN USING THE MAXIMUM SENSITIVITY SETTING, THE PERFORMANCE light is illuminated continuously or a PI value of < 0.25 is displayed. OF THE SENSOR OFF DETECTION MAY BE COMPROMISED. IF THE UNIT IS IN THIS SETTING AND THE SENSOR BECOMES DISLODGED FROM CAUTION: IF LOW PERFUSION INDICATION IS FREQUENTLY DISPLAYED, FIND A THE PATIENT, THE POTENTIAL FOR FALSE READINGS MAY OCCUR BETTER PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION STATUS THROUGH OTHER MEANS. DUE TO ENVIRONMENTAL ‘NOISE’ SUCH AS LIGHT, VIBRATION AND EXCESSIVE AIR MOVEMENT. ACTIONS TO BE TAKEN BATTERY LEVEL INDICATOR If the SpO2 readings show significant differences, do the following: Four LED indicators provide information on the remaining battery capacity. The operator Make sure the emitter and photodetector are aligned directly opposite each other. should monitor these indicators periodically to determine remaining battery life and if the Select a site where the distance between the emitter and photodetector is minimized. batteries should be replaced. Battery capacity is indicated in the following chart. Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (10- INDICATION BATTERY CAPACITY 30% methyl salicylate and 2-10% menthol) and allow to dry for 20-30 seconds. 4 LEDs 100% to 75% Strong vasodilator creams, such as nitroglycerin paste, are not recommended. 3 LEDs 75% to 50% If possible, remove electrical noise sources such as electrosurgical units or other electrical/electronic equipment. 2 LEDs 50% to 25% 1 LED 25% to 10% If artificial nails or excessive fingernail polish are present, select another site or remove the polish/artificial nails. 1 FLASHING LED WITH AUDIBLE ALARM 10% to 0% If possible, ensure that the sensor is placed in a location with low ambient light. CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE PATIENT’S VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE CO- OXIMETER FOR PROPER FUNCTIONING. 4-6 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-7  4 operation operation 4 LOW BATTERY AUDIBLE ALARM Normal Patient Monitoring During normal operation, the Rad-57 Display shows oxygen saturation (as % SpO2) on the If a low battery condition occurs during patient monitoring, a low priority alarm will sound, upper number and Pulse Rate (in beats per minute) on the lower number. and can be silenced for 120 seconds by pressing the Alarm Silence Button. On each model, a 10-LED bar displays the following parameters: If a low battery condition occurs while not monitoring a patient, pressing the Alarm Silence Button will suspend the the alarm until the power is cycled or patient monitoring begins. Carboxyhemoglobin saturation (%SpCO) and Perfusion Index (PI) on the Rad-57c. Methemoglobin saturation (%SpMet) and Perfusion Index (PI) on the Rad-57m. If a low battery condition occurs, immediately discontinue patient monitoring and replace the batteries. Carboxyhemoglobin saturation (%SpCO) and Methemoglobin saturation (%SpMet) on the Rad-57cm. Low Perfusion Index (PI) is displayed with a single LED on this NOTE: Remove batteries when storing unit for prolonged periods to maintain battery life. model or the numeric value may be viewed by pressing the Display button. The following sections describe the function of the Rad-57 front panel controls during WARNING: FAILURE TO REPLACE BATTERIES PROMPTLY AFTER A LOW normal patient monitoring. BATTERY ALARM MAY RESULT IN THE CO-OXIMETER SHUTTING DOWN AND RAD-57 FRONT PANEL CONTROL OPERATION LEAVING THE PATIENT IN AN UNMONITORED CONDITION. BUTTON FUNCTION WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE Rad-57c and Rad-57m: BATTERIES MAY AFFECT THE ACCURACY OF THE BATTERY LEVEL METER. Pressing this button will display the numeric SpCO/SpMet value in place of the SpO2/pulse rate numeric value. Pressing this button again will return to WARNING: USE OF BATTERIES WITH A CELL VOLTAGE OF MORE THAN 1.5V the SpO2/pulse rate numeric value. Rad-57c COULD CAUSE DAMAGE TO THE RAD-57. NOTE: If any parameter breaches its pre-set alarm limit, the Rad-57 will automatically display the alarming parameter. Pressing Display during an alarm condition will enable the display of other parameters for 10 seconds. In WARNING: EFFECTIVE BATTERY LIFE WILL BE REDUCED WHEN OPERATING Rad-57m the event of a multi-parameter alarm condition, the SpO2 / Pulse Rate display THE INSTRUMENT BELOW 5ºF (-15º C) DUE TO ALKALINE BATTERY will take priority. TECHNOLOGY. Rad-57cm: Pressing this button will display the numeric SpCO value in place of the SpO2 numeric value and the SpMet value in place of the pulse rate. Pressing this button again will display the PI numeric value in place of the SpMet value. Pressing this button again will return to the SpO2 and pulse rate numeric value. Rad-57cm NOTE: If any parameter breaches its pre-set alarm limit, the Rad-57 will automatically display the alarming parameter. Pressing Display during an alarm condition will enable the display of other parameters for 10 seconds. In the event of a multi-parameter alarm condition, the SpO2 / Pulse Rate display