signal extraction pulse oximeters O P E R A T O R ’ S M A N U A L...
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Signal Extraction Pulse Oximeter OPERATOR’S MANUAL...
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The Rad-5 and Rad-5v Operating Instructions intend to provide the necessary information for proper opera- tion of all Rad-5 and Rad-5v pulse oximeter models. There may be information provided in this manual that is not relevant for your pulse oximetry system.
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SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES The Rad-5/5v Handheld Pulse Oximeter’s software program is designed to minimize the pos- sibility of hazards from errors by following sound engineering design processes, Risk Analysis and Software Validation. ■ Explosion hazard. Do not use the Pulse Oximeter in the presence of flammable anes- thetics or other flammable substance in combination with air, oxygen-enriched environ- ments, or nitrous oxide.
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■ Reorient or relocate the receiving device. ■ Increase the separation between the equipment. ■ Consult the manufacturer for help. Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual...
A b o u t t h i s M a n u a l This manual explains how to set up and use the Rad-5/5v Handheld Pulse Oximeter. Important safety information relating to general use of the Rad-5/5v Pulse Oximeter appears before this introduction.
Sample of Caution: CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A NOTE is provided when extra general information is applicable. Sample of Note: NOTE: This is a sample of a Note. Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual...
P r o d u c t D e s c r i p t i o n The Rad-5 family of Handheld Pulse Oximeters are noninvasive, arterial oxygen saturation and pulse rate monitors. The Rad-5 family features a multicolored LED display that con- tinuously displays numeric values for SpO and pulse rate, as well as LED indicator bars for Perfusion Index (PI) and Signal Identification and Quality Indicator (Signal IQ ®...
This information may be useful to clinicians. The radiant power of the light is rated at 0.79mW (max.). See figure below. The Rad-5/5v utilizes a sensor with red and infrared light-emitting diodes (LEDs) that pass light through the site to a photodiode (detector).
1. Light Emitting Diodes (LEDs) 2. Recessed Detector Once the Rad-5/5v receives the signal from the sensor, it utilizes Masimo SET signal extrac- tion technology for calculation of the patient’s functional oxygen saturation and pulse rate. FUNCTIONAL VS. FRACTIONAL SATURATION The Rad-5/5v is calibrated to measure and display functional saturation: the amount of oxy- genated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen.
A Red Direct Connect Spot Check Sensor or Masimo Patient Cable and Masimo sensor attach to the connector on the top of the Rad-5/5v unit. The Rad-5/5v can be used either for spot checks or continuous (Rad-5) SpO 2 monitoring.
Used to enter the setup menus and to select/activate certain Mode / Enter Button entries within the menu/setup system. Used within the menu/setup system to move through setup Next Button options. Not active during normal patient monitoring. Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual...
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Provides control of the front panel indicator brightness. Cycles through four brightness levels. At the brightest level, pressing the Display Brightness Display Brightness button will return the display to the lowest brightness setting. Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual...
Located inside battery compartment and on back Serial Number Label of device Agency Approvals Label Battery Cover Press down and slide the battery cover off the Battery Cover Release bottom of the oximeter Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual...
SYMBOLS The following symbols are found on the Rad-5/5v or on the packaging and are defined below. Consult accompanying documents WEEE compliant Mark of Conformity to European Medical Device Directive...
Rad-5/5v Handheld Pulse Oximeter. POWER REQUIREMENTS The Rad-5 and Rad-5v are 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.
Turn the unit on, verify all indicators illuminate and speaker sounds a brief tone. No other setup is required. Refer to Section 4, General Setup and Use for additional steps to verify proper functioning of the unit. Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual...
I n t r o d u c t i o n To operate the Rad-5 or Rad-5v Pulse Oximeters effectively, the operator must: ■ Know how the oximeter derives its readings (see Section 1, Pulse Oximetry) ■...
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Disconnect the sensor from the patient cable or oximeter. ■ Confirm that “NO SEn” message appears on the display. NOTE: “NO SEn” and “SEn OFF” will only generate an alarm if the Rad-5/5v was actively monitoring a patient when the sensor was disconnected. 14. Rad-5 only: Verify parameter-violation alarm silence operation.
THE SENSOR IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE SEN- SORS AND CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE. SEE THE CLEAN- ING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS. ■...
The signal quality indicator displayed on the Rad-5/5v is called the Signal IQ. The Signal IQ can be used to identify the occurrence of a patient’s pulse and the associated signal quality of the measurement.
LOW PERFUSION The Rad-5/5v indicates perfusion on a 10-bar LED indicator. The lower two segments of the bar will turn red when the amplitude of the arterial pulsations is very low (low perfusion).
SENSITIVITY The Rad-5 is equipped with 3 different sensitivity modes. Each mode allows the clinician to change the sensitivity settings of the device to meet the increased demands of the patient’s physiological condition or enable it to work during periods of low perfusion and/or motion.
WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BAT- TERIES 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 DEVICE. Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual...
During normal operation, the Rad-5/5v Display shows oxygen saturation (as % Sp0 ) on the upper number and Pulse Rate (in beats per minute) on the lower number. The following sections describe the function of the Rad-5/5v front panel controls during normal patient monitoring. RAD-5v FRONT PANEL CONTROL OPERATION...
S e t u p M e n u ( R a d - 5 o n l y ) This section gives an overview of available Rad-5 menu selections. These selections DO NOT apply to the Rad-5v. To navigate through the menus, use the Mode/Enter, Next, and Up and Down keys located on the front panel of the oximeter below the LED display.
Trend ON / OFF Use Down key to turn Trend OFF Set Year Set Month Use Up or Down Arrow Keys to Set Day adjust parameter to desired setting. Set Hour Set Minute Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-11...
■ PR alarm keys up / down will scroll numbers. NOTE: The date and time must be set before trending will be enabled. The Rad-5 will automatically ‘time out’ of the setup menu after 10 seconds with no key presses. If the Rad-5 should time-out to the Trend Settings menu, the trend will not be enabled.
A special serial cable (see Section 10, Accessories) is required to connect the sensor con- nector of the Rad-5 to the PC. Patient monitoring is not possible while trend memory is being transferred to a PC.
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-5 off or replacing the batteries will not erase the trend data. Turn trending off before storing the unit for any length of time.
SLEEP MODE OPERATION The Rad-5 can be placed into the Sleep Mode to allow the unit to capture normal and abnormal data without triggering alarms. This mode will blank out the unit display with the exception of the Battery Level Indicator and the Alarm Silenced Indicator and disable the alarms even after a power cycle.
An alarm condition is indicated by an audible alarm tone and visual alarm indicator. An out-of-limit parameter will flash on the Rad-5 only. “SEn OFF” and “nO SEn” will only generate an alarm condition after a pulse has been found.
Push 3rd time - Return to Audible Alarm Active. ALARM SILENCED INDICATOR The Alarm Silenced Indicator provides visual feedback when illuminated, the Rad-5 audible alarms are muted. While monitoring a patient, acknowledging an alarm condition by pressing the Alarm Silence Button (one time) will silence the alarm tone for 120 seconds and the Alarm Silenced Indicator will flash.
MESSAGES The Rad-5/5v will indicate other data or system errors. Message conditions for the Rad-5 follow: DISPLAY TYPE SOLUTION Assess /address patient condition.
32°F to 122°F (0°C to 50°C) Transportation/Storage Temperature: -40°F to 158°F (-40°C to +70°C) Storage Humidity: 5% to 95%, non-condensing 500 mbar to 1060 mbar pressure, Operating Altitude: -1000 ft to 18,000 ft (-304 m to 5,486 m) Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual...
70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population. 4 Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator.
Rad-5/5v Handheld Pulse Oximeter performance. Tissue damage can be caused by incorrect application or use of a Masimo sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor.
USE SENSORS ON THE SAME PATIENT M a s i m o S E T P a t i e n t C a b l e s Reusable patient cables of various lengths are available. Only use appropriate Masimo oximetry patient cables for SpO measurements.
BATTERY REPLACEMENT The Rad-5 and Rad-5v are 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 replace 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.
To test the performance of the Rad-5/5v pulse oximeter following repairs or during routine maintenance, follow the procedure outlined in this section. If the Rad-5/5v fails any of the described tests, discontinue its use and correct the problem before returning the unit back to the user.
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/ m a i n t e n a n c e LED Brightness: Rad-5: with the monitor turned on, select menu level 3 (see Section 4, Setup Menu Level 3 - LED Brightness and Factory Defaults) and use the Up and Down Arrow keys to cycle through all 4 brightness levels.
Section 9, Cleaning. Make sure it is fully dry before packing the equip- ment. To return the Rad-5/5v unit for service, please follow the Return Procedure. WARNING: DO NOT REMOVE THE COVER OF THE MONITOR EXCEPT FOR BATTERY REPLACEMENT.
W a r r a n t y Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: (i) each new Product and the Software media as delivered are free from defects in workmanship or materials, and (ii) the Product and Software will perform substantially as labeled in the directions for use.
Ownership of Software/Firmware: Title to, ownership of, and all rights and interests in, any MASIMO software and/or firmware and the documentation, and all copies thereof, remain at all times vested in MASIMO Corporation, licensor to MASIMO, and they do not pass to Purchaser.
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