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Table of Contents
Related Manuals for Masimo Pronto Pulse CO-Oximeter
Summary of Contents for Masimo Pronto Pulse CO-Oximeter
- Page 1 Operator's Manual ® ® Pronto Pulse CO-Oximeter...
- Page 3 80fk Patents: www.masimo.com/patents.htm © 2016 Masimo Corporation , Discrete Saturation Transform, DST, FST, Masimo, Pronto, Pulse CO-Oximeter, rainbow, rainbow ReSposable, SET, Signal Extraction Technology, Signal I.Q., and SpHb are federally registered trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners.
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Page 5: Table Of Contents
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 13 Compliance Warnings and Cautions ---------------------------------------------------------------- 14 Chapter 1: Technology Overview ------------------------------------------------------------------------ 15 Masimo Signal Extraction Technology (Masimo SET®) ----------------------------------------- 15 rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 17 Chapter 2: System Description -------------------------------------------------------------------------- 21... - Page 6 Battery Replacement ---------------------------------------------------------------------------------- 57 Performance Verification ----------------------------------------------------------------------------- 58 Service and Repair ------------------------------------------------------------------------------------- 58 Limited Warranty ------------------------------------------------------------------------------------- 60 Exclusions ---------------------------------------------------------------------------------------------- 60 Limitation of Warranty ------------------------------------------------------------------------------- 60 Sales & End-User License Agreement -------------------------------------------------------------- 61 Restrictions --------------------------------------------------------------------------------------------- 61 Index --------------------------------------------------------------------------------------------------------- 63 www.masimo.com Masimo...
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Page 7: About This Manual
CAUTION: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note. www.masimo.com Masimo... -
Page 9: Product Description, Features, And Indications For Use
Download capabilities to transfer data from the device to a computer. Indications for Use The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET® Pronto... -
Page 11: Safety Information, Warnings, And Cautions
Pronto before bathing the patient. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. CAUTION: Do not place the Pronto where the controls can be changed by the patient. www.masimo.com Masimo... -
Page 12: Performance Warnings And Cautions
• Hypocapnic or hypercapnic conditions • Severe anemia • Very low arterial perfusion • Extreme motion artifact • Abnormal venous pulsation or venous constriction • Severe vasoconstriction or hypothermia • Arterial catheters and intra-aortic balloon www.masimo.com Masimo... - Page 13 Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers. etc. • Skin color disorders • Elevated altitude • EMI radiation interference CAUTION: Do not place the Pronto on electrical equipment that may affect the device, preventing it from working properly. www.masimo.com Masimo...
- Page 14 Note: Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling. Note: Additional information specific to the Masimo sensors compatible with Pronto, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU).
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Page 15: Cleaning And Service Warnings And Cautions
1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur. Note: Excessive cleaning solution can flow into the monitor and cause damage to internal components. www.masimo.com Masimo... -
Page 16: Compliance Warnings And Cautions
Note: To satisfy RF exposure requirements, this device and its antenna must operate with a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. Note: This Class B digital apparatus complies with Canadian ICES-003. www.masimo.com Masimo... -
Page 17: Chapter 1: Technology Overview
Masimo products. Masimo Signal Extraction Technology (Masimo SET®) The signal processing in Masimo Signal Extraction Technology (Masimo SET®) differs from that of conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion,... - Page 18 Pronto Chapter 1: Technology Overview Masimo SET® DST This figure is for conceptual purposes only. General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
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Page 19: Rainbow Pulse Co-Oximetry Technology
Maximum skin-sensor interface temperature was tested to be less than 41º C (106º F) in a minimum ambient temperature of 35º C (95º F). The tests were conducted with sensors operating at reasonable worst case power. www.masimo.com Masimo... - Page 20 Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration, and perfusion. See Safety Information, Warnings, and Cautions on page 9. www.masimo.com Masimo...
- Page 21 For more information, see Low Signal I.Q. (Low SIQ) on page 40. www.masimo.com Masimo...
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Page 23: Chapter 2: System Description
A spot check sensor or patient cable attaches to the connector on the top of Pronto. Front Panel www.masimo.com Masimo... - Page 24 When in the device menu, use the Up or Up/Down Arrow Buttons Down arrow buttons to scroll through menu setting options. For more information, see Navigating the Menu on page 31. Provides audible indication of alert conditions, pulse tone, and feedback for Speaker control button presses. www.masimo.com Masimo...
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Page 25: Rear Panel
Pronto Chapter 2: System Description Rear Panel Ref. Feature Serial Number Label Certification Label Battery Cover Battery Cover Release www.masimo.com Masimo... -
Page 27: Chapter 3: Setup
Turn on Pronto. All LEDs will briefly illuminate and an audible tone will sound. If necessary, configure the device for your regional power line frequency (LF) (50 hz or 60 hz). See Default Settings on page 29. www.masimo.com Masimo... -
Page 29: Chapter 4: Operation
During this period, the sensor is initializing and adjusting to the patient. PI, PR, and SpO2 parameters/measurements (depending on user configuration) will appear on the main display. No other quality control activities (such as calibration) are required. www.masimo.com Masimo... - Page 30 To view older readings after a reading has been performed, press the Up or Down arrow buttons to view different parameters. The parameter label blinks indicating the value obtained might be older or not correlate with the patient. Parameters display in this order: SpHb, PI, PR, and SpO2. www.masimo.com Masimo...
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Page 31: Default Settings
50, 60 Hz Software Version HH, MX (read only) SpHb Calibration Venous Venous, Arterial (SpHbv) Pulse Tone On, Off SpHb Units of Grams per Grams per Deciliter, Millimoles per Measurement Deciliter Liter Display Measurements On, Off During Low SIQ www.masimo.com Masimo... -
Page 32: Audible Alerts
Battery capacity is indicated in the following chart: LED Indicators Battery Capacity 4 LEDs 100% to 75% 3 LEDs 74% to 50% 2 LEDs 49% to 25% 1 LED 24% to 10% 1 Flashing LED with audible alert 9% to 0% www.masimo.com Masimo... -
Page 33: Navigating The Menu
Year (Current Year) Sets Year (00-99) Month (current month) Sets Month (01-12) Day (current day) Sets Day (00-31) Hour (current hour) Sets Hour (00-23) Minute (current minute) Set Minute (00-59) Clear Trend (Yes) CLR TND Clear Trend (No) (Default) www.masimo.com Masimo... - Page 34 PI Off LF 60(Default) LF 50 Software Version HH Software (Default) Software Version MX Software SpHbv Calibration Venous(Default) SpHb Calibration Arterial Pulse Tone Off (Default) Pulse Tone On Grams per Deciliter (g/dL) (Default) Milimoles per Liter (mmol/L) On (Default) www.masimo.com Masimo...
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Page 35: Trend Setup And Use
Turning Pronto off will not erase the trend data. For detailed instructions on erasing trend memory, see the TrendCom Directions for Use (DFU). Note: Do not turn off the device for at least one minute after clearing the trend. www.masimo.com Masimo... - Page 36 Exception Messages 400 = Low Signal IQ 800 = Masimo SET. This flag means the algorithm is running in full Masimo SET® mode. It requires a Masimo SET® sensor and needs to acquire some clean data for this flag to be set.
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Page 37: Chapter 5: Messages
All error codes require return of System Fault the device to an authorized service center for repair. See Return Procedure on page 59. Defective sensor Replace sensor. The Masimo ReSposable RPL SEN Replace the Masimo ReSposable sensor sensor system is system. non-functional. www.masimo.com Masimo... - Page 38 Attach new sensor. Dispose of the old sensor per local governing ordinances. Zero sensor uses remaining SEN 000 See Compliance Warnings and Cautions on page 14. Confirm sensor placement and press Spot check incomplete RE TST SpHb button again. www.masimo.com Masimo...
- Page 39 Chapter 5: Messages Message Explanation Next Steps The reusable part of the Disconnect the reusable part of the Masimo ReSposable sensor ReSposable sensor system. Assemble system is connected to the NO ADH the ReSposable sensor system and then device, but the adhesive connect to the device.
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Page 41: Chapter 6: Troubleshooting
5ºF (-15ºC) due to indicator level. If the battery capacity than expected alkaline battery remains low, replace batteries. See Battery Replacement on page 57. capacity. technology www.masimo.com Masimo... -
Page 42: Low Perfusion
Read Safety Information, Warnings, and Cautions on page 9 and the sensor Directions for Use (DFU). After performing the above, perform another spot check. An arterial blood specimen for laboratory CO-Oximetry analysis may be considered to verify the oxygen saturation and hemoglobin values. www.masimo.com Masimo... -
Page 43: Low Battery Audible Alert
WARNING: Use of batteries with a cell voltage of more than 1.5V could cause damage to the device. WARNING: Effective battery life will be reduced when operating the device below 5ºF (-15ºC) due to alkaline battery technology. Note: Remove batteries when storing device for prolonged periods to maintain battery life. www.masimo.com Masimo... -
Page 45: Chapter 7: Specifications
No Motion 8 g/dL - 17 g/dL 1 g/dL *The A Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68% of the measured values fell within +/- the A value when compared to the reference device under a controlled study. www.masimo.com Masimo... -
Page 46: Display Ranges
0.1 g/dL Pulse Rate 1 bpm Electrical Battery Type Four (4) AA alkaline Capacity Operates continuously for up to eight (8) hours without changing batteries [7] Isolation No external power or ground connection, internally powered only, DC current www.masimo.com Masimo... -
Page 47: Environmental
13oz. (0.37 kg) Trend Memory Trending Stores a minimum of 10,000 time-stamped spot check result data in trend Memory memory Alerts Audible Alerts Low Battery, System Failure Audible Tone 500 Hz tone, three (3) pulse burst, repeat time: 5s www.masimo.com Masimo... -
Page 48: Display Indicators
Low Signal IQ Indicator, Battery Level Indicator, Spot Check Progress Indicator, Indicators Pulse Indicator, and Sensor Use Indicator Type Compliance Safety Compliance UL 60601-1 CSA C22.2 No. 601.1 IEC/EN 60601-1, 2nd Ed. IEC/EN 60601-1, 3rd Ed. IEC 60601-1-11 IEC 62366 ISO 80601-2-61 www.masimo.com Masimo... - Page 49 EN 60601-1-2, Class B Equipment Classification per IEC 60601-1 Type of Protection Internally powered (battery powered) Degree of Protection Against Electric Type BF-Applied Part Shock Not for use in the presence of flammable Environment anesthetics Mode of Operation Continuous Operation www.masimo.com Masimo...
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Page 50: Citations
60% - 100% SpO2, against a laboratory CO-Oximeter. Contact Masimo for testing specifications. The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. -
Page 51: Symbols
Mark of Conformity to European Medical Device Directive 93/42/EEC Federal law (USA) restricts this device to sale by or on the order of a physician Manufacturer Date of Manufacture Product contains no natural rubber latex Product contains no PVC (polyvinyl chloride) material www.masimo.com Masimo... - Page 52 Storage Temperature Range Storage/Transport Relative Humidity Range Keep Dry Fragile/Breakable, Handle with Care Authorized representative in the European community UL, LLC. Certification Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs Note: eIFU is not available for CE mark countries. www.masimo.com Masimo...
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Page 53: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Therefore, its RF emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment. RF Emissions Suitable for use in all establishments, including domestic Class B environments. CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 www.masimo.com Masimo... -
Page 54: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
[ME EQUIPMENT or ME SYSTEM] be powered from an 70 % UT (30 % uninterruptible power supply or a dip in UT) for battery. 25 cycles <5 % UT (>95 % dip in UT) for 5 s www.masimo.com Masimo... - Page 55 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol: www.masimo.com Masimo...
- Page 56 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. www.masimo.com Masimo...
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Page 57: Recommended Separation Distances
(W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. www.masimo.com Masimo... -
Page 59: Chapter 8: Service And Maintenance
(+ and -) 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. For more information about battery disposal, see Compliance Warnings and Cautions on page www.masimo.com Masimo... -
Page 60: Performance Verification
Service and Repair Repair Policy Masimo or an authorized service department must perform warranty repair and service. Do not use malfunctioning equipment. Have the device repaired. Clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning on page 57. Make sure the equipment is fully dry before packing. - Page 61 Clean contaminated/dirty equipment before returning, following instructions in Cleaning on page 57. Make sure the equipment is fully dry before packing. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA number. Package the equipment securely, in...
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Page 62: Limited Warranty
Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software. -
Page 63: Sales & End-User License Agreement
Sales & End-User License Agreement 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”) except as otherwise expressly agreed in a separate contract for the acquisition of this Product, the following terms are the entire agreement between the parties regarding your purchase of this Product. -
Page 65: Index
Cautions • 13 Initial Setup • 25 Compliance • 46 Compliance Warnings and Cautions • 14, 36, 57 Limitation of Warranty • 60 Contacting Masimo • 59 Limited Warranty • 60 Contraindications • 7 Low Battery Audible Alert • 41 www.masimo.com Masimo... - Page 66 Safety Warnings and Cautions • 9 Sales & End-User License Agreement • 61 Masimo SET® DST • 16 Service and Repair • 58 Masimo SET® Parallel Engines • 15 SpO2 and SpHb Measurements During Masimo Signal Extraction Technology Patient Motion • 19 (Masimo SET®) •...
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