Masimo Pronto Pulse CO-Oximeter Operator's Manual

Masimo Pronto Pulse CO-Oximeter Operator's Manual

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Pronto
®
O P E R A T O R ' S
M A N U A L
Masimo Pronto
Pulse CO-Oximeter™

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Summary of Contents for Masimo Pronto Pulse CO-Oximeter

  • Page 1 Pronto ® O P E R A T O R ’ S M A N U A L Masimo Pronto Pulse CO-Oximeter™...
  • Page 3 These operating Instructions intend to provide the necessary information for proper operation of the Masimo Pronto ® Pulse CO-Oximeter. General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of the Masimo Pronto Pulse CO-Oximeter are prerequisites for proper use.
  • Page 4: Safety Information, Warnings And Cautions

    ■ As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. ■ Do not place the Pronto or accessories in any position that might cause it to fall on the patient. Do not lift the Pronto by the cable or sensor. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 5 80s. When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. ❚ Intravascular dyes such as indocyanine green or methylene blue ❚ Externally applied coloring (such as nail polish) Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 6 ■ Do not place the Pronto face against a surface. This can cause the a system or battery (non- clinical) alarm to be muffled. ■ Additional information specific to Masimo sensors including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's Directions For Use (DFU)..
  • Page 7 ■ Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories. ■ This Class B digital apparatus complies with Canadian ICES-003. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 8: Table Of Contents

    Numeric Display - SpO 2 ..........................4-4 Numeric Display - Pulse Rate .....................4-4 Numeric Display - PI ......................4-4 Low Perfusion ........................4-4 Low Signal IQ (Low SIQ) ....................4-5 Troubleshooting Sensor Placement ..................4-5 Low Battery Audible Alarm ....................4-6 Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 9 Masimo Rainbow® Sensors ......................8-2 SpHb Rainbow Reusable and Adhesive Sensors ...............8-2 Sphb Rainbow Resposable Pulse Oximeter Sensor System ..........8-3 Sensor Accuracy .........................8-3 Cleaning and Reuse of Masimo Reusable Sensors and Cables ........8-3 Section 9 - Service and Maintenance Introduction .............................9-1 Cleaning ............................9-1 Battery Replacement ......................9-2...
  • Page 10: Section 1 Overview

    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 Masimo Pronto Pulse CO-Oximeter. Important safety information relating to general use of the device appears before this introduction. Other important safety information is located throughout the manual where appropriate.
  • Page 11: Warnings, Cautions And Notes

    Sample of Caution: CAUTION: This is a sample of a caution statement. A NOTE is provided when additional general information is applicable. Sample of Note: NOTE: This is a sample of a Note. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 12: Product Description

    ■ Automatic shutdown power conservation 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 (SpO 2 ), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse...
  • Page 13: Pulse Co-Oximetry

    The sensor connects directly to the instrument (1). The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as measurement of total hemoglobin concentration. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 14: Principle Of Operation

    ≤ 25mW. The detectors receive the light, convert it into an electronic signal and sends it to the Pronto for calculation. Once the Pronto receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology to calculate the patient’s functional oxygen saturation, (SpO 2 %), total...
  • Page 15: Functional Saturation

    O v e r v i e w at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure. Functional Oxygen Saturation The Pronto is calibrated to measure and display functional oxygen saturation (SpO 2 ): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen.
  • Page 16: Masimo Set Parallel Engines

    O v e r v i e w Masimo SET Parallel Engines SpOC Masimo SET DST ® � � Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 17 O v e r v i e w Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 18: Introduction

    Page 1 of 1 © 2001 Masimo Corporation FRM 1379 Rev A All Rights Reserved DRO 5201 Masimo Pronto Pulse CO-Oximeter Operator’s Manual CONFIDENTIAL AND PROPRIETARY Page 1 of 1 © 2001 Masimo Corporation FRM 1379 Rev A All Rights Reserved...
  • Page 19 DRO 5201 Buttons use the Up and Down arrow buttons to scroll through menu setting options. (See Section 4, Operation.) Provides audible indication of alarm conditions, pulse tone, and Speaker feedback for control button presses. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 20: Rear Panel

    R x Only UL 60601-1 UL 60601-1 Masimo, SET, , and SIQ are registered trademarks of Masimo Corporation. Rad-57 is a trademark of Masimo Corporation. Rainbow and SpCO are registered trademarks of Masimo Laboratories. Signal Extraction Pulse CO-Oximeter and SpMet are trademarks of Masimo Laboratories.
  • Page 21: Symbols

    Sensor/Cable symbols, 03/06 EU authorized representative Title: symbol, art, keep dry PCX-1044 Revision: A DRO-4150 Title: Graphics, Sensor/Cable symbols, 03/06 GR-14231 DRO-13914 Title: symbol, art, fragile PCX-1045 Underwriter's Laboratories Inc. certification Revision: A DRO-4150 Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 22: Introduction

    S e t u p I n t r o d u c t i o n Before the Masimo Pronto Pulse CO-Oximeter can be used, it needs to be inspected and properly setup, including inserting the batteries. 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 23: Initial Setup

    No other setup is required. Refer to Section 4, Operation, General Setup and Use for additional steps to verify proper functioning of the device. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 24: 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 Masimo Pronto Pulse CO-Oximeter effectively, the operator must: ■ Know how the Pulse CO-Oximeter derives its readings (see Section 1, Pulse CO-Oximetry) ■...
  • Page 25: Default Settings

    Software Version (read only) SpHb Calibration Venous (SpHb v ) Venous, Arterial Pulse Tone On, Off Grams per Deciliter SpHb Units of Measurement Grams per Deciliter Millimoles per Liter Display Low SIQ Values On, Off Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 26: Successful Sphb Spot Check

    ■ Do not sterilize by irradiation, steam, autoclave or ethylene oxide unless otherwise indicated in the sensor's directions for use. Sensor cleaning instructions are in the Directions for Use. ■ Do not attempt to reprocess, recondition or recycle Masimo sensors as these processes may damage the electrical components, potentially leading to patient harm.
  • Page 27: Numeric Display - Spo 2

    (This may occur even with a pulse rate that correlates with the ECG heart rate.) * Severinghaus JW, Spellman MJ. Pulse Oximeter Failure Thresholds in Hypotension and Vasoconstriction Anesthesiology 1990; 73:532-537 Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 28: Low Signal Iq (Low Siq)

    O p e r a t i o n Low Signal IQ (Low SIQ) The Masimo Pronto Pulse CO-Oximeter provides a visual indicator of low signal quality through the LED when displayed SpO 2 , SpHb, PI and/or PR values are not based on adequate signal quality.
  • Page 29: Low Battery Audible Alarm

    Battery capacity is indicated in the following chart. INDICATION 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 Alarm 9% to 0% Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 30: Setup Menu

    Page 1 of 1 FRM 1379 Rev A Press SpHb DRO 5201 LF 50 Software Version HH Software (Default) Software Version to confirm your choice. MX Software SpHb v Calibration Venous(Default) SpHb Calibration Arterial Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 31 Exit the Menu and Power Off the Device To exit the menu, allow 10 minutes of inactivity, or press the Up and Down arrows simultaneously. Press the Power On/Off button for 2 seconds to turn off the instrument. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 32: Trend Setup And Use

    TrendCom Directions for Use (DFU) for detailed instructions on Download and Operation. NOTE: During download of spot check trend information, all normal Pronto functions are unavailable and the keypad is locked, except for the power button. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 33: Erasing Trend Memory

    004 = Low Perfusion Messages 400 = Low Signal IQ 800 = Masimo SET. This flag means the algorithm is running in full SET mode. It requires a SET sensor and needs to acquire some clean data for this flag to be set Sample Trend Output 11/30/11 00:09:36 SpO2=100 PR=070 PI=01.32 SpCO=00.00 Met=00.00 SpHb=15.1 PVI=000 EXC=00000000...
  • Page 34: Messages

    ReSposable Sensor Replace the Masimo ReSposable System is non- Sensor System functional. Ensure that the sensor is properly Interference detected applied, and cover the sensor site with opaque material, if required. (Blinking) outs, 10/06 Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 35 Replace the adhesive part of the ReSposable Sensor ReSposable Sensor System. System is incompatible or unrecognized. The adhesive part of the Masimo Replace the adhesive part of the ReSposable Sensor ReSposable Sensor System. System is non- functional. Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 36: Troubleshooting

    5 degrees level. If the battery capacity remains low, capacity less than Fahrenheit due to alkaline replace batteries. expected capacity battery technology Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 38: Specifications

    Refer to Safety Information, Warnings and Cautions ELECTRICAL Batteries Type 4 AA alkaline Operates continuously for up to 8 hours without changing batteries 7 Capacity Isolation No external power or ground connection, internally powered only, DC current Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 39 68% of the population. Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Fluke Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
  • Page 40: Introduction

    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. It should be used as a reference and not as a substitute for the sensor's Directions for Use (DFU).
  • Page 41: Masimo Rainbow® Sensors

    M a s i m o R a i n b o w ® S e n s o r s Masimo SpHb Rainbow sensors must be used for the Masimo Pronto Pulse CO-Oximeter parameters to enable measurement of Oxyhemoglobin (SpO2) and Total Hemoglobin (SpHb).
  • Page 42: Sphb Rainbow Resposable Pulse Oximeter Sensor System

    NOTE: If the sensor fails to track the pulse consistently, the sensor may be incorrectly positioned. Reposition the sensor or choose a different measurement site. CAUTION: Do not attempt to reprocess, recondition or recycle any masimo sensors or patient cables as these processes may damage the electrical components, potentially leading to patient harm.
  • Page 43 S e n s o r s a n d P a t i e n t C a b l e s Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 44: Introduction

    ■ Do not use petroleum-based, acetone solutions, or other harsh solvents, to clean the Pronto. These substances erode the instrument's materials and instrument failure can result. Refer to Section 8, Cleaning and Reuse of Masimo Reusable Sensors and Cables for cleaning instructions of the sensor.
  • Page 45: Battery Replacement

    1. Turn the instrument on by pressing the Power Button. For about 5 seconds all available LEDs are illuminated and a brief beep tone sounds. 2. The sensor uses remaining will display. 3. The Pronto is ready for use (the "rdY" message appears). Masimo Pronto Pulse CO-Oximeter Operator’s Manual...
  • Page 46: 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 47: 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 48: End-User License

    2. Ownership of Software: The Software is licensed not sold; all rights and interests in the Software and all copies thereof remain at all times vested in Masimo, and do not pass to Purchaser. Any references in this Agreement to the purchase or sale of the Software shall be deemed the purchase or sale of a Software License as set forth herein.
  • Page 49 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 50: Accessories

    Pronto Operator's Manual, Dutch 32907 Pronto Operator's Manual, Danish 32908 Pronto Operator's Manual, Portuguese 32909 Pronto Operator's Manual, Chinese 32910 Pronto Operator's Manual, Japanese Please visit our website, www.masimo.com, for updated information about Masimo products Masimo Pronto Pulse CO-Oximeter Operator’s Manual 10-1...
  • Page 52 Devices and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo.

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