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Summary of Contents for Masimo RAD-57C
- Page 1 O P E R A T O R ’ S M A N U A L Masimo Rainbow ® ® Signal Extraction Pulse CO-Oximeter™ Covers: Rad-57c: with SpO 2 and SpCO Rad-57m: with SpO 2 and SpMet Rad-57cm: with SpO 2, SpCO...
- Page 2 Signal Extraction Pulse CO-Oximeter™ OPERATOR'S MANUAL...
- Page 4 , SET, LNCS, LNOP, Signal IQ, Discrete Saturation Transform, DST, FastSat and SpCO are registered trademarks of Masimo Corporation. Rad-57, Rad-57c, Rad-57m, Rad-57cm, SIQ, LNOPv, SpMet, Pulse CO-Oximeter and APOD are trademarks of Masimo Corporation. Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual...
- Page 5 ■ Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to replace the batteries. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment. ■ As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
- Page 6 SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES ■ Always remove the sensor from the patient and completely disconnect the patient from the Pulse CO-Oximeter before bathing the patient. ■ Do not place the Pulse CO-Oximeter where the controls can be changed by the patient. ■...
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Page 7: Table Of Contents
Principle of Operation ....................1-6 Functional vs. Fractional Saturation ................. 1-6 Measured vs. Calculated Values ................1-7 Masimo SET Signal Extraction Technology for SpO measurements ...... 1-7 SpCO and SpMet measurements during patient motion ......... 1-7 Masimo SET Parallel Engines .................. 1-8 ®... - Page 8 SECTION 8 - SENSOR AND PATIENT CABLES Introduction ........................8-1 Selecting a Sensor ....................8-1 Sensor Application Instructions ................8-1 ® Masimo Rainbow Sensors.................... 8-2 Rainbow Reusable Sensors ..................8-2 Rainbow Adhesive Sensors ..................8-2 Masimo SpO Sensors ....................8-2 Red Reusable Sensors ...................
- Page 9 LNOPv Adhesive Sensors .................... 8-4 ™ Sensor Accuracy ..................... 8-4 Cleaning And Reuse Of Masimo Reusable Sensors and Cables ......8-4 Reattachment of Single Use Adhesive Sensors ............8-4 SECTION 9- SERVICE / MAINTENANCE Introduction ........................9-1 Cleaning ......................... 9-1 Battery Replacement ....................
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Page 10: About This 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-57c, Rad-57m and Rad-57cm Signal Extraction Pulse CO-Oximeter. These three products will be generally referred to as the Rad- 57. -
Page 11: Warnings, Cautions And Notes
o v e r v i e w W a r n i n g s , C a u t i o n s a n d N o t e s Please read and follow any warnings, cautions and notes presented throughout this manual. -
Page 12: Product Description
P r o d u c t D e s c r i p t i o n ® ® The Rad-57 Handheld Pulse CO-Oximeter with Masimo Rainbow Technology is a noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-57 features a... -
Page 13: Indications For Use
o v e r v i e w INDICATIONS FOR USE The Rad-57 and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO ), pulse rate, carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor)* and methemoglobin saturation (measured by a SpCO/SpMet sensor)*. -
Page 14: Pulse Co-Oximetry
CO-Oximetry device or through a patient cable. The sensor collects signal data from the patient and sends it to the device. 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. -
Page 15: Principle Of Operation
(7 + wavelengths) 2. Detector Once the Rad-57 receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology to calculate the patient’s functional oxygen saturation, blood levels of carboxyhemoglobin (SpCO*), methemoglobin (SpMet*) and pulse rate. The SpCO and SpMet measurements rely on a multiwavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin in arterial blood. -
Page 16: Functional Vs. Fractional Saturation
(sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. -
Page 17: Masimo Set Parallel Engines
MASIMO RAINBOW SET PARALLEL ENGINES This figure is for conceptual purposes only. R/IR Intermediate Calculations (Conventional Confidence Pulse Oximetry) ® Intermediate Calculations Adaptive Confidence Wavelengths Filter Intermediate Calculations SST ™ Confidence Confidence Post Pre-Processing &... -
Page 18: Introduction
The Rad-57 is powered by 4 “AA” alkaline batteries, which provides a minimum of 8 hours of battery life. ■ Rad-57 offers full Masimo Rainbow SET Technology in a small, hand held device. ■ Rad-57 supports the full line of Masimo sensors (see Section 8, sensors and patient cables). -
Page 19: Rad-57C Front Panel Controls
%SpCO %SpO 1.75 1.25 <3 <.1 %SpCO Rad-57c CONTROL / INDICATOR DESCRIPTION Connects to a Rainbow Sensor or Rainbow Patient Cable, Patient Cable Connector Red Sensor or a Red Patient Cable with an LNOP, LNOPv or LNCS Sensor. Slow flashing indicator: The confidence in the SpCO value obtained is low. - Page 20 s y s t e m d e s c r i p t i o n CONTROL / INDICATOR DESCRIPTION Pressing this button will display the numeric SpCO value in place of the SpO numeric value and CO in the place of Display Button pulse rate.
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Page 21: Rad-57M Front Panel Controls
s y s t e m d e s c r i p t i o n R a d - 5 7 m F r o n t P a n e l C o n t r o l s r a i n b o w Signal Extraction Pulse CO-Oximeter SpMet... - Page 22 s y s t e m d e s c r i p t i o n CONTROL / INDICATOR DESCRIPTION Pressing this button will display the numeric SpMet value Display Button in place of the pulse rate numeric value until the SpMet button is pressed again.
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Page 23: Rad-57Cm Front Panel Controls
s y s t e m d e s c r i p t i o n R a d - 5 7 c m F r o n t P a n e l C o n t r o l s r a i n b o w Signal Extraction Pulse CO-Oximeter Low PI... - Page 24 s y s t e m d e s c r i p t i o n CONTROL / INDICATOR DESCRIPTION Pressing this button will display the numeric SpCO value in place of the SpO numeric value and the SpMet value in place of the pulse rate.
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Page 25: Rad-57 Rear Panel (All Models)
s y s t e m d e s c r i p t i o n R a d - 5 7 R e a r P a n e l ( a l l m o d e l s ) DESCRIPTION CONTROL / INDICATOR Serial Number Label... -
Page 26: Symbols
s y s t e m d e s c r i p t i o n 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 WEEE Compliant... -
Page 28: Introduction
s e t u p I n t r o d u c t i o n 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. U n p a c k i n g a n d i n s p e c t i o n Remove the device from the shipping carton and examine for signs of shipping damage. -
Page 29: Monitor Setup
s e t u p M o n i t o r S e t u p INITIAL SETUP 1. Inspect the oximeter case for damage. 2. Install 4 (four) new AA alkaline batteries. 3. Turn the device on, the LEDs will scroll in the display window as the sensor calibrates, verify all indicators illuminate and speaker sounds a brief tone. -
Page 30: Introduction
o p e r a t i o n I n t r o d u c t i o n To operate the Rad-57 Pulse CO-Oximeter effectively, the operator must: ■ Know how the oximeter derives its readings (see Section 1, Pulse CO-Oximetry) ■... - Page 31 o p e r a t i o n GENERAL SETUP AND USE (CONTINUED) 11. On the display, for each corresponding parameter and applicable unit, verify the readings for SpO , SpCO, SpMet and pulse rate (See Model Summary for applicable unit).
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Page 32: Default Settings
o p e r a t i o n DEFAULT SETTINGS The Rad-57 is shipped configured with all values set to factory default. Adjustments made by the user will be retained after a power cycle for all values except alarm silence. NOTE: Before use, confirm that the device settings are set appropriately. -
Page 33: Successful Spo Monitoring
AUTOCLAVE OR ETHYLENE OXIDE (UNLESS OTHERWISE INDICATED ON THE SENSOR DIRECTIONS FOR USE). SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO LNOP, LNOPv, LNCS OR RAINBOW SENSORS. 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). -
Page 34: Numeric Display - Pulse Rate
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 percent on the Rad-57cm. A percentage greater than 1.00 percent is desired. Extreme changes in the display number are due to changes in physiology and blood flow. -
Page 35: Low Perfusion
Low Perfusion is indicated when the arterial pulsations are very low (weak perfusion). Low 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 light is illuminated continuously or a PI value of <... -
Page 36: Sensitivity
o p e r a t i o n SENSITIVITY Three sensitivity levels enables a clinician to tailor the response of the Rad-57 to the needs of the particular patient situation. They are as follows: ■ Normal Sensitivity – This is the recommended mode for typical monitoring purposes. -
Page 37: Low Battery Audible Alarm
o p e r a t i o n LOW BATTERY AUDIBLE ALARM If a low battery condition occurs during patient monitoring, a low priority alarm will sound, and can be silenced for 120 seconds by pressing the Alarm Silence Button. 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. -
Page 38: Normal Patient Monitoring
Pulse Rate (in beats per minute) on the lower number. On each model, a 10-LED bar displays the following parameters: ■ Carboxyhemoglobin saturation (%SpCO) and Perfusion Index (PI) on the Rad-57c. ■ Methemoglobin saturation (%SpMet) and Perfusion Index (PI) on the Rad-57m. -
Page 39: Setup Menu
o p e r a t i o n S e t u p M e n u This section gives an overview of the Rad-57 menu selections available. To navigate through the menus, use the Mode/Enter, Next, Up and Down keys located on the front panel of the Pulse CO-Oximeter, below the LED display. -
Page 40: Setup Menu Level 4 - Trend Settings
o p e r a t i o n SETUP MENU LEVEL 3 – AVERAGING AND SENSITIVITY Push the Mode/Enter button again to enter menu level 3. BUTTON SETTING Sensitivity. HI = Maximum Use Up or Down Arrow Keys Nor = Normal to adjust parameter to desired APO = APOD setting. -
Page 41: Setup Menu Level 5 - Led Brightness And Factory Defaults
o p e r a t i o n SETUP MENU LEVEL 4 - TREND SETTINGS (CONTINUED) NOTE: The date and time must be set before trending will be enabled. The Rad-57 will automatically ‘time out’ of the setup menu after 10 seconds with no key presses. If the Rad- 57 should time-out of the Trend Settings menu, the trend will not be enabled. -
Page 42: Special Menu
o p e r a t i o n S p e c i a l M e n u This section gives an overview of the Rad-57 special menu selection available. To navigate through the menu, use the Power, Next, Up and Down keys located on the front panel of the oximeter. -
Page 43: Trend Setup And Use
PC and TrendCom software is required to download the trend data on to the PC. Refer to Section 10 - Accessories and contact Masimo to acquire these optional items. Patient monitoring is not possible while trend memory is being transferred to a PC. -
Page 44: Erasing Trend Memory
200 = reserved 400 = Low Signal IQ 800 = Masimo SET. This flag means the algorithm is running in full SET mode. It requires a Masimo sensor and needs to acquire some clean data for this flag to be set. -
Page 45: Sample Trend Output
o p e r a t i o n SAMPLE TREND OUTPUT 02/08/06 16:40:50 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000001 No Cable 02/08/06 16:40:52 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000001 No Cable 02/08/06 16:40:54 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:40:56 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:40:58 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:00 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor... -
Page 46: Alarm Indication
a l a r m s / m e s s a g e s A l a r m I n d i c a t i o n An alarm condition is indicated by: ■ Audible alarm tone ■... - Page 47 a l a r m s / m e s s a g e s ALARM LIMITS (CONTINUED) SETTING RANGE The SpMet high alarm limit can be set anywhere between .5% and 30% with a .5% SpMet* High Limit step size. In the “----“ (off) setting, the SpMet High Alarm Limit Alarm is disabled. Factory default setting is 3%.
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Page 48: Alarm Silence
a l a r m s / m e s s a g e s ALARM SILENCE Audible alarms may be suspended, while visual alarms may not. The alarm suspension setting is controlled by the Alarm Silence Button. Pressing the Alarm Silence Button will suspend the alarm for 120 seconds. -
Page 49: Messages
2. Attempt to warm patient. (PI) BAR* TURNS RED 3. Move sensor to better perfused site. (Bottom two LEDs only.) Low Signal Strength NOTE: Masimo recommends using OR LOW PI LED IS an adhesive sensor whenever low FLASHING perfusion is expected or evident. - Page 50 a l a r m s / m e s s a g e s MESSAGES CONTINUED DISPLAY TYPE SOLUTION Continuously indicates the concentration of Methemoglobin in the following increments: .5, 1, 2, 3, 4, 5, 7.5, 10, 15 % SpMet* BAR GRAPH Alarm Condition and >20%.
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Page 52: Troubleshooting
t r o u b l e s h o o t i n g T r o u b l e s h o o t i n g The following chart describes what to do if the Rad-57 system does not operate properly or fails. - Page 53 PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION Improper sensor type or application. Check and see if blood flow to the site is LOW SIGNAL Excessive motion relative restricted. QUALITY to perfusion. Check the placement of the sensor. Re-apply sensor or move to a different site. Sensor is damaged or not functioning.
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Page 54: Rad-57 Family Specifications
s p e c i f i c a t i o n s Rad-57 Family Specifications PERFORMANCE Measurement range Oxygen Saturation (%SpO 1-100% Carboxyhemoglobin Saturation (%SpCO*) 0 - 99% Methemoglobin Saturation (%SpMet*) 0 - 99.9% Pulse Rate (bpm): 25-240 beats per minute Perfusion Index: 0.02 - 20% ACCURACY... -
Page 55: Electrical
s p e c i f i c a t i o n s ACCURACY (CONTINUED) Interfering Substances Carboxyhemoglobin and methemoglobin may erroneously increase oxygen saturation readings. The level of increase is approximately equal to the amount of carboxyhemoglobin and/or methemoglobin present. - Page 56 3 Masimo Rainbow SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
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Page 58: Introduction
& p a t i e n t c a b l e s I n t r o d u c t i o 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. -
Page 59: Masimo Rainbow ® Sensors
S e n s o r s ® Masimo Rainbow sensors must be used with the Rad-57 to enable measurement of Carboxyhemoglobin (SpCO) and Methemoglobin (SpMet). Rainbow sensors will only function with instruments containing Masimo Rainbow SET Technology or licensed to use Rainbow compatible sensors. -
Page 60: Lnop ® Reusable Sensors
s e n s o r s & p a t i e n t c a b l e s M a s i m o S p O S e n s o r s c o n t i n u e d ®... -
Page 61: Lncs ® Adhesive Sensors
Accuracy specified when used with Masimo Rainbow SET technology pulse CO-Oximetry monitors or with licensed Masimo SET pulse oximetry modules during no motion. Numbers represent ± 1 standard deviation. Plus or minus one standard deviation represents 68% of the population. -
Page 62: Introduction
HARSH SOLVENTS, TO CLEAN THE OXIMETER. THESE SUBSTANCES ATTACK THE DEVICE’S MATERIALS AND DEVICE FAILURE CAN RESULT. Refer to Section 8, Cleaning and Reuse of Masimo Reusable Sensors and Cables for cleaning instructions of the sensor and patient cables. Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual... -
Page 63: Battery Replacement
s e r v i c e / m a i n t e n a n c e BATTERY REPLACEMENT 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. -
Page 64: Performance Verification
s e r v i c e / m a i n t e n a n c e P e r f o r m a n c e V e r i f i c a t i o n To test the performance of the Rad-57 Pulse CO-Oximeter following repairs or during routine maintenance, follow the procedure outlined in this section. -
Page 65: Service And Repair
Please clean contaminated/dirty equipment before returning and make sure it is fully dry before packing the equipment. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA number. Package the equipment securely – in the original shipping container if possible –... -
Page 66: Sales & End-User License Agreement
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. -
Page 67: End-User License
2. Ownership of Software: Software is licensed not sold. All rights and interests in the Software and all copies thereof, remain at all times vested in Masimo and they do not pass to Purchaser. Any references in this Agreement to the purchase of sale of the Software shall be deemed the purchase of the sale of a Software License as set forth herein. -
Page 68: Restrictions
License, in whole or in part, by operation of law or otherwise without Masimo's prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included. -
Page 70: Accessories
a c c e s s o r i e s A c c e s s o r i e s PART NUMBER DESCRIPTION 1842 Rubber protective boot, Grey 1980 Rubber protective boot, Yellow 1981 Rubber protective boot, Red 1982 Rubber protective boot, Orange 2097... - Page 71 Devices and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo.
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