Related Manuals for Masimo SET Rainbow SET Rad-57
Summary of Contents for Masimo SET Rainbow SET Rad-57
- Page 1 O P E R A T O R ’ S M A N U A L Masimo Rainbow ® ® Signal Extraction Pulse CO-Oximeter™...
- Page 3 The Rad-57 Signal Extraction Pulse CO-Oximeter Operating Instructions intend to provide the necessary infor- mation for proper operation of all Rad-57 Pulse CO-Oximeter models. General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of the Rad-57 Signal Extraction Pulse CO-Oximeter models are prerequisites for proper use.
- Page 4 CONTRAINDICATIONS: The Rad-57 is contraindicated for use as an apnea monitor. Safety Information, Warnings and Cautions The Rad-57™ 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. ■...
- Page 5 Safety Information, Warnings and Cautions, continued ■ Do not place the Rad-57 where the controls can be changed by the patient. ■ Do not place the Rad-57 on electrical equipment that may affect the instrument, preventing it from working properly. ■...
- Page 6 Safety Information, Warnings and Cautions, continued z Externally applied coloring (such as nail polish) z Elevated levels of bilirubin z Severe anemia z Low arterial perfusion z Motion artifact ■ Do not place the Rad-57 against a surface or cover the speaker. This can cause the system or battery (non clinical) alarm to be muffled.
- Page 7 Safety Information, Warnings and Cautions, continued ■ This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B. ■ A functional tester cannot be utilized to assess the accuracy of the Rad-57 or any sensors. ■...
-
Page 8: Table Of Contents
Principles of Operation ......................1-8 Functional vs. Fractional Saturation ..................1-9 Rad-57 vs. Drawn Whole Blood Measurements ..............1-9 Masimo SET Signal Extraction Technology For SpO Measurements .........1-9 SpMet, and SpCO Measurements During Patient Motion ............1-9 Masimo Rainbow SET Parallel Engines................1-10 Masimo SET DST ® ......................1-10 SECTION 2 - SYSTEM DESCRIPTION Introduction .......................... - Page 9 T a b l e o f C o n t e n t s Pleth Variability Index - PVI (upgraded Instrument) ..............4-8 Low Signal IQ (Low SIQ) ......................4-8 Low Perfusion........................4-8 Actions to be Taken ......................4-9 Sensitivity ..........................4-9 Battery Level Indicator ......................4-10 Low Battery Audible Alarm ....................4-10 Normal Patient Monitoring ......................4-11 Rad-57 Front Panel Control Operation ................
- Page 10 T a b l e o f C o n t e n t s Rainbow Adhesive Sensors ....................8-2 Rainbow Direct Connect Sensors ..................8-3 Rainbow Reusable Sensors ....................8-3 Rainbow Resposable™ Pulse CO-Oximeter Sensor System ..........8-3 Masimo SpO Sensors ......................8-4 Red Reusable Sensors ......................8-4 ®...
-
Page 11: About This Manual
O v e r v i e w 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-57 Instrument Signal Extraction Pulse CO-Oximeter. Important safety information relating to general use of the Rad-57 appears before this introduction. Other important safety information is located throughout the manual where appropriate. -
Page 12: 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 13: Product Description
The following list outlines the key features and benefits of the Rad-57 Handheld Pulse CO-Oximeter. Features and Benefits ® ■ Clinically proven Masimo SET technology performance ■ Proven for accurate SpO and pulse rate monitoring in motion and low perfusion environments ■... -
Page 14: Indications For Use
O v e r v i e w Indications for Use The Masimo SET® Rad-57 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and carboxyhemoglobin and methemoglobin saturation or methemoglobin (measured by an SpCO/SpMet sensor). -
Page 15: Pulse Co-Oximetry
O v e r v i e w P u l s e C O - O x i m e t r y SpO 2 General Description Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. -
Page 16: Spco General Description
O v e r v i e w 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. -
Page 17: Fastsat
O v e r v i e w FastSat FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend. When the Rad-57 is set to FastSat “On”, the averaging algorithm evaluates all the saturation values providing an averaged saturation value that is a better representation of the patient’s current oxygenation status. -
Page 18: Principles Of Operation
O v e r v i e w Principles of Operation Pulse 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). -
Page 19: 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 20: Masimo Rainbow Set Parallel Engines
O v e r v i e w Masimo Rainbow SET Parallel Engines This figure is for conceptual purposes only. Masimo SET DST ® 1-10 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual... -
Page 21: Introduction
S y s t e m D e s c r i p t i o n I n t r o d u c t i o n The Rad-57 is a full featured Pulse CO-Oximeter designed for ease of operation. All pulse oximetry measurement information, as well as instrument status data, is displayed on the front panel of the instrument. -
Page 22: Rad-57 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 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 Rad-57 CONTROL / INDICATOR... - Page 23 S y s t e m D e s c r i p t i o n Provides audible indication of alarm conditions, pulse tone and feedback Speaker for key-presses. Ensure the speaker is not covered or the Instrument is placed face-down on bedding or other sound absorbing surface.
-
Page 24: Rad-57 Rear Panel
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 GR-10887 GRAPHIC DOCUMENTATION AND APPROVAL DRO-8890 GR-10887 GRAPHIC DOCUMENTATION AND APPROVAL Approvals DRO-8890 GR-10887... -
Page 25: Symbols
S y s t e m D e s c r i p t i o n Symbols The following symbols may be found on the back of the Rad-57 Signal Pulse CO-Oximeter or packaging and are defined below: SYMBOL DESCRIPTION Caution, consult accompanying documents Follow Instructions for Use... - Page 26 S y s t e m D e s c r i p t i o n Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual...
-
Page 27: 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 instrument from the shipping carton and examine for signs of shipping damage. -
Page 28: 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 Instrument on, the LEDs will scroll in the display window as the sensor calibrates, verify all indicators illuminate and speaker sounds a brief tone. -
Page 29: 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 30 O p e r a t i o n ■ Sensitivity Setting ■ Averaging Time ■ FastSat: Setting *available in upgraded Instrument 10. On the display, for each corresponding parameter/measurement, verify the readings (depending on the sensor used), for , PVI*, SpCO*, SpMet* NOTE: “- - - “...
-
Page 31: 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 instrument settings are set appropriately. - Page 32 O p e r a t i o n FACTORY DEFAULT CONFIGURABLE SETTING/BEHAVIOR AT OPTION SETTING POWER-UP Set to Pre-Power Down Setting Alarm Volume (Default is level 1) Levels 1 through 4 Set to Pre-Power Down Setting Line Frequency (Default is 60 Hz) 50 Hz/ 60 Hz Set to Pre-Power Down Setting Trend Active...
-
Page 33: Successful Spo Monitoring
O p e r a t i o n S u c c e s s f u l S p O M o n i t o r i n g The following general points will aid in ensuring oximetry monitoring success. ■... -
Page 34: Numeric Display - Pulse Rate
O p e r a t i o n ■ Externally applied coloring (such as nail polish) ■ Elevated levels of bilirubin ■ Severe anemia ■ Low arterial perfusion ■ Motion artifact Numeric Display - Pulse Rate The Pulse Rate displayed on the Rad-57 may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times. -
Page 35: Numeric Display - Spco (Upgraded Instrument)
O p e r a t i o n Numeric Display - SpCO (upgraded Instrument) stable SpCO reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. -
Page 36: Numeric Display - Pi
O p e r a t i o n Numeric Display - PI The Perfusion Index (PI) display provides a relative numeric indication of the pulse strength at the monitoring site. It is a calculated percentage between the pulsatile signal and nonpulsatile signal of arterial blood moving through the site. -
Page 37: Actions To Be Taken
O p e r a t i o n Actions to be Taken If the SpO readings show significant differences, do the following: ■ Make sure the emitter and photodetector are aligned directly opposite each other. ■ Select a site where the distance between the emitter and photodetector is minimized. ■... -
Page 38: Battery Level Indicator
O p e r a t i o n Battery Level Indicator 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. Low Battery Audible Alarm If a low battery condition occurs during patient monitoring, a medium priority alarm will sound, and can be acknowledged by pressing the Alarm Silence Button. -
Page 39: Normal Patient Monitoring
GR-11085 APHIC DOCUMENTATION AND APPROVAL O p e r a t i o n s, 4/05 DRO-11386 Approvals GR-11085 D APPROVAL Date Marketing Communications Date DRO-11386 N o r m a l P a t i e n t M o n i t o r i n g 4/1/05 The following sections describe the function of the Rad-57 front panel controls during normal patient monitoring. -
Page 40: Setup Menu Level 1 - Alarm Volume And Alarm Silence
GRAPHIC DOCUMENTATION AND APPROVAL Buttons, 4/05 DRO-11386 Approvals Date Marketing Communications Date O p e r a t i o n 4/1/05 itle Program Setup Menu Level 1 – Alarm Volume and Alarm Silence lustration, Rainbow, Buttons, 6/05 Adobe Illustrator 10.0 (.eps) Push the Enter button to enter menu level 1. -
Page 41: Setup Menu Level 3 - Sensitivity, Averaging, Fastsat, Smarttone
GR-11085 GRAPHIC DOCUMENTATION AND APPROVAL O p e r a t i o n uttons, 4/05 DRO-11386 Approvals GR-11085 GRAPHIC DOCUMENTATION AND APPROVAL Date Marketing Communications Date uttons, 4/05 Setup Menu Level 3 – Sensitivity, Averaging, FastSat, SmartTone DRO-11386 4/1/05 GR-11085 GRAPHIC DOCUMENTATION AND APPROVAL Push the Enter button again to enter menu level 3. -
Page 42: Setup Menu Level 4 - Trend Settings
O p e r a t i o n Setup Menu Level 4 - Trend Settings Push the 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. -
Page 43: Setup Menu Level 5 - Led Brightness And Factory Defaults
GR-11085 RAPHIC DOCUMENTATION AND APPROVAL tons, 4/05 DRO-11386 O p e r a t i o n Approvals Date Marketing Communications Date 4/1/05 GR-11085 RAPHIC DOCUMENTATION AND APPROVAL Setup Menu Level 5 - LED Brightness and Factory Defaults tons, 4/05 DRO-11386 Program Push the Enter button again to enter menu level 5. -
Page 44: 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. The oximeter has options that allow user configuration to suit specific needs. -
Page 45: Trend Setup And Use
O p e r a t i o n T r en d S e t u p a n d U s e Introduction The Rad-57 can store 72 hours of SpO Pulse Rate (PR), PVI*, SpCO*, SpMet* and Perfusion Index trend data, captured at 2 second intervals. - Page 46 200 = 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 47: Alarm Indication
A l a r m s a n d 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 48 A l a r m s a n d M e s s a g e s SETTING RANGE The SpO 2 high alarm limit can be set to “----” (Off)or anywhere between 2% and 99%, with a 1% step size. In the “----” (off) setting, the SpO 2 High Limit alarm is SpO 2 High Limit disabled.
-
Page 49: Alarm Silence
A l a r m s a n d 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 50: Messages
A l a r m s a n d M e s s a g e s Messages The Rad-57 will indicate other data or system errors. Message conditions for the Rad-57 follow: DISPLAY REASON SOLUTION Assess /address patient condition. NUMERIC VALUE Parameter alarm FLASHES... - Page 51 A l a r m s a n d M e s s a g e s DISPLAY REASON SOLUTION Return for service. There are several error codes. All error codes require return of the Instrument to an System Fault authorized service center for repair.
- Page 52 A l a r m s a n d M e s s a g e s DISPLAY REASON SOLUTION Temporary blinking message: Cable life expired Replace cable as soon as possible Temporary blinking message: Sensor life expired Replace sensor as soon as possible Temporary blinking message: Adhesive sensor life Replace adhesive sensor as soon as possible...
-
Page 53: 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. PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION... - Page 54 T r o u b l e s h o o t i n g PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION Check for error messages. See section 5=Messages for recommended corrections. SpO 2 VALUES DO Check placement of sensor or if it is too tight. NOT CORRELATE Low perfusion or sensor Reapply sensor or select a new site.
-
Page 55: Rad-57 Specifications
S p e c i f i c a t i o n s R a d - 5 7 S p e c i f i c a t i o n s PERFORMANCE Measurement Range 0 -100% SpMet*: 0 - 99.9% SpCO*: 0 - 99%... -
Page 56: Electrical
S p e c i f i c a t i o n s Interfering Substances Carboxyhemoglobin and methemoglobin will erroneously alter oxygen saturation readings. The level of increase is approximately equal to the amount of carboxyhemoglobin and/or methemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings. - Page 57 S p e c i f i c a t i o n s Compliance EMC Compliance: EN60601-1-2, Class B Equipment Classification: IEC 60601-1 Type of Protection: Internally powered (on battery power) Degree of Protection-Patient Cable: Type BF-Applied Part Mode of Operation: Continuous 1 SpO 2, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% - 100% SpO 2, 0% - 40% SpCO and 0% - 15% SpMet against a laboratory CO-Oximeter.
- Page 58 S p e c i f i c a t i o n s Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual...
-
Page 59: Introduction
S e n s o r s a n d 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 60: Masimo Rainbow ® Sensors
S e n s o r s a n d P a t i e n t C a b l e s Masimo Rainbow ® Sensors Masimo Rainbow sensors must be used with the Rad-57 to enable measurement of Carboxyhemoglobin (SpCO), and/or Methemoglobin (SpMet). -
Page 61: Rainbow Direct Connect Sensors
S e n s o r s a n d P a t i e n t C a b l e s Rainbow Direct Connect Sensors SpO 2 and SpMet and pulse rate accuracy for the Rainbow sensors is specified in the following table. Rainbow Direct Connect sensors connect to the instrument directly. -
Page 62: Masimo Spo Sensors
The Rad-57 may also use standard Masimo LNOP, LNOPv and LNCS SpO sensors, when used with Red PC and LNCS Cables respectively. This will allow the Rad-57 to work as a Masimo SET pulse oximeter without the carboxyhemoglobin or methemoglobin measurement. -
Page 63: Lnop ® Specialty Sensors
S e n s o r s a n d P a t i e n t C a b l e s LNOP ® Specialty Sensors LNOP sensors must be used in conjunction with Red PC cables. Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy Sensor... -
Page 64: M-Lncs ™ /Lncs ® Specialty 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 65: Introduction
S e r v i c e a n d M a i n t e n a n c e I n t r o d u c t i o n This chapter covers how to test the operation of the Rad-57, how to properly clean the Rad-57 Pulse CO-Oximeter, how to replace the batteries and how to obtain service. -
Page 66: Battery Replacement
S e r v i c e a n d 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 instrument. -
Page 67: Alarm Limit Test
S e r v i c e a n d M a i n t e n a n c e Alarm Limit Test 1. With the monitor turned on, select the Menu Access key and enter the Alarm menu. Change the High Saturation Alarm parameter to a value two points below the currently selected value, and accept the change. - Page 68 S e r v i c e a n d M a i n t e n a n c e ■ Warranty information – a copy of the invoice or other applicable documentation must be included. ■ Purchase order number to cover repair if the oximeter is not under warranty, or for tracking purposes if it is.
-
Page 69: Sales & End-User License Agreement
S e r v i c e a n d M a i n t e n a n c e L i c e n s e A g r e e m e n t S a l e s & E n d - u s e r 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"). -
Page 70: End-User License
S e r v i c e a n d M a i n t e n a n c e L i c e n s e E n d - U s e r 1. Grant of License: In consideration of payment of the Software license fee, which is part of the price paid for the Product, Masimo grants to Purchaser a nonexclusive, nontransferable (except as set forth below) license ("License"), without right to sublicense, to use the copy of the Software in connection with Purchaser's use of the Product for its labeled purpose as set forth in these... -
Page 71: 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 73 www.masimo.com Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo.
Need help?
Do you have a question about the Rainbow SET Rad-57 and is the answer not in the manual?
Questions and answers