Masimo RainbowTM SET® Pulse CO-Oximeter OPERATOR’S MANUAL
The Rad-57 Operating Instructions intend to provide the necessary information for proper operation of all Rad-57 Pulse CO-Oximeter models. General knowledge of pulse oximetry and an understanding of the features and functions of the Rad-57 Pulse CO-Oximeter are prerequisites for proper use. Do not operate the Rad-57 Pulse CO-Oximeter without completely reading and understanding these instructions.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES The Rad-57 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 Pulse CO-Oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
table of contents SECTION 1 - OVERVIEW About this Manual................................................................................................................ 1-1 Warnings, cautions and notes ............................................................................................. 1-2 Product Description ............................................................................................................. 1-3 Features and Benefits .......................................................
table of contents TM LNCS Adhesive Sensors............................................................................................................8-3 TM LNOPv Adhesive Sensors............................................................................................. 8-4 Cleaning And Reuse Of Masimo reusable Sensors and cables .............................. 8-4 Reattachment of Single Use adhesive Sensors.......................................................
1 overview overview Warnings, cautions and notes Product Description Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: The Rad-57 Rainbow SET Pulse CO-Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor.
1 overview Pulse Oximetry 1 overview 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. SpO2 GENERAL DESCRIPTION Pulse 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.
1 overview are abnormal (less than 90% for arterial oxygen saturation, and greater than 1% 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 core oxygen saturation and carboxyhemoglobin concentration of the patient are stable and not changing over the period of time that the blood gas sample is taken.
system description 2 Introduction The Rad-57 is a full featured Pulse CO-Oximeter designed for ease of operation. All pulse oximetry measurement information, as well as device status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel and the sensor cable connection is located at the top edge of the device. The Rad-57 is powered by 4 “AA” alkaline batteries, which provide over 8 hours of battery life.
2 system description system description 2 Rad-57 front panel controls CONTROL / INDICATOR 1 2 6 SpCO Button Pressing this button will display the numeric SpCO value for 10 seconds in place of the SpO2 numeric value. Pressing the Mode/Enter or Next button during this 10second period will return to the SpO2 numeric value. 7 Mode / Enter Button Used to enter the setup menus and to select/activate certain entries within the menu/setup system.
2 system description setup 3 Rad-57 rear panel 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. FOR PLACEMENT ONLY 2XXX FOR PLACEMENT ONLY XXX XXX XXX XXX Rx Only Masimo Corporation Irvine, CA 92618 USA 2XXX Unpacking and inspection Remove the instrument from the shipping carton and examine for signs of shipping damage. Check all materials against the packing list.
3 setup operation Monitor setup Introduction INITIAL SETUP To operate the Rad-57 Pulse CO-Oximeter effectively, the operator must: 1. Inspect the oximeter case for damage. 2. Install 4 (four) new AA alkaline batteries. 3. Turn the unit on, the LEDs will scroll in the display window as the sensor calibrates, verify all indicators illuminate and speaker sounds a brief tone. 4. Configure the unit for your regional power line frequency (50 or 60 hz) if needed.
4 operation ■ An alarm tone sounds. ■ The violated alarm parameter flashes. 12. Verify the sensor alarms are functional by removing the sensor from the sensor site. ■ “SEn OFF” message appears on the display. ■ The alarm tone sounds. ■ The Visual Alarm Indicator flashes. ■ Disconnect the sensor from the patient cable or oximeter. ■ Confirm that “NO SEn” message appears on the display.
4 operation Successful SpO2 monitoring The following general points will aid in ensuring oximetry monitoring success. ■ Place the sensor on a site that is not too thick, has sufficient perfusion and provides proper alignment of the LED’s and photodetector. ■ Place the sensor on a site that has unrestricted blood flow. ■ Do not constrict the monitoring site when securing a sensor with tape. ■ Do not select a site near potential electrical interference (electrosurgical unit, for example).
4 operation NUMERIC DISPLAY - SpCO A stable SpCO reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient's fingertip (measurement site). Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. Inaccurate measurements may be caused by: ■ Significant levels of methemoglobin.
4 operation BATTERY LEVEL INDICATOR operation 4 RAD-57 FRONT PANEL CONTROL OPERATION Four LED indicators provide information on the remaining battery capacity. The operator should monitor these indicators periodically to determine remaining battery life and if the batteries should be replaced. Battery capacity is indicated in the following chart.
4 operation 4 operation SETUP MENU LEVEL 1 – ALARM VOLUME SETUP MENU LEVEL 4 - TREND SETTINGS Push the Mode/Enter button to enter menu level 1. Push the Mode/Enter button again to enter menu level 4. To enable trending of patient data, the trend feature must be enabled (set to ON), and the current date and time must be set. See Section 4, Trend setup and use. SETTING Alarm Volume Use Up or Down Arrow Keys to adjust parameter to desired setting.
4 operation operation 4 Trend Setup and Use MENU TIMEOUT INTRODUCTION Additionally, the Rad-57 will automatically return to patient monitoring display from any menu level/setting after a 10 seconds with no key presses. The Rad-57 can store 72 hours of SpO2, Pulse Rate, SpCO and Perfusion Index trend data, captured at 2 second intervals. This trend data can then be transferred to a PC for evaluation.
4 operation alarms / messages ERASING TREND MEMORY Alarm Indication To erase (clear) the trend memory, turn the trend off and back on again. Enabling trend (setting Trend to “ON”) will erase all trend data. An alarm condition is indicated by: Note: Turning trend off will not erase trend memory. You may turn trending off and still retrieve the trend data using TrendCom. Turning the Rad-57 off or replacing the batteries will not erase the trend data.
5 alarms / messages ALARM SILENCE 5 alarms / messages MESSAGES Audible alarms may be suspended, while visual alarms may not. There are three audible alarm suspension settings, all controlled by the Alarm Silence Button. Repeated pressing the Alarm Silence Button will cycle though all three Alarm Silence options. Power-On – Alarms are active and Alarm Silenced Indicator is off. Push Once – Alarm is silenced for 120 seconds and Alarm Silenced Indicator flashes.
5 alarms / messages MESSAGES CONTINUED DISPLAY Troubleshooting TYPE SOLUTION No Cable Connected Connect appropriate cable to unit. The following chart describes what to do if the Rad-57 system does not operate properly or fails. PROBLEM There are several error codes. All error codes require return of the unit to an authorized service center for repair. See Section 9, Service and Repair. POSSIBLE CAUSE(S) Interference from linefrequency induced noise. Return for service.
7 specifications Rad-57 family specifications PERFORMANCE measurement range Oxygen Saturation (%SpO2): 1-100% Carboxyhemoglobin Saturation (%SpCO ) 1 - 99% Pulse Rate (bpm): Perfusion Index: 25-240 beats per minute 0.
7 specifications ELECTRICAL Batteries Type: 4 “AA” Alkaline5 Capacity: over 8 hours4 Isolation: No external power or ground connection, internally powered only. ENVIRONMENTAL Operating Temperature: 41°F to 104°F (5°C to 40°C) -40°F to 158s°F (-40°C to +70°C)5 Storage Temperature: Operating Humidity: 5% to 95%, non-condensing Operating Altitude: 500 mbar to 1060 mbar pressure, -1000 ft to 18,000 ft (-304 m to 5,486 m) PHYSICAL CHARACTERISTICS Dimensions: 6.2” x 3.0” x 1.4” (15.8 cm x 7.
sensors & patient cables 8 Introduction This section covers the use and cleaning of Masimo sensors and patient cables. Before use of any sensor, carefully read the sensor’s Directions for Use. Use only Masimo oximetry sensors for SpO2 and SpCO measurements. Other oxygen transducers or sensors may cause improper Rad-57 Pulse CO-Oximeter performance. Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly.
8 sensors & patient cables 8 sensors & patient cables ® M a s i m o R a i n b o w TM s e n s o r s LNOP ADHESIVE SENSORS (LNOP sensors must be used in conjunction with Red PC cables) Masimo Rainbow sensors must be used with the Rad-57 to enable measurement of Carboxyhemoglobin (SpCO). Rainbow sensors will only function with oximeter devices equipped with Masimo Rainbow SET Technology. SENSOR LNOP Adt Rainbow sensors connect to the device directly or with a patient cable.
8 sensors & patient cables TM LNOPv ADHESIVE SENSORS (LNOPv sensors must be used in conjunction with Red PC cables) SENSOR LNOPv In Weight Range 3 - 20 kg LNOPv Ne < 3 kg Saturation Accuracy No Motion Motion ± 2% ± 3% ± 3% ± 3% Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm ± 3 bpm ± 5 bpm Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm ± 3% ± 3 bpm LNOPv Ad > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm LNOPv Ne > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm 10
9 service / maintenance the device. Remove the batteries and install new 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.
9 service / maintenance Service and repair Warranty REPAIR POLICY Masimo warrants to the initial purchaser that each new Pulse CO-Oximeter will be free from defects in workmanship or materials for a period of one (1) year from the date of purchase. Masimo’s sole obligation under this warranty is to repair or replace any product that Masimo deems to be covered under warranty with a repaired or a replacement Pulse CO-Oximeter.
9 service / maintenance accessories 10 Accessories 3. Assignment: Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise, without MASIMO's prior written consent; any attempt without such consent, to assign any rights, duties or obligations arising hereunder shall be void. 4. Copy Restrictions: The software/firmware and the accompanying written materials are copyrighted.
www.masimo.com Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo. © 2005 Masimo Corporation. Masimo, SET, LNOP, Radical, Signal IQ and FastSat are registered trademarks of Masimo Corporation. LNCS, Rad, Rad-57, SIQ, FastStart and APOD are trademarks of Masimo Corporation. Rainbow, SpCO and Pulse CO-Oximeter are trademarks of Masimo Laboratories.
