Masimo PRONTO-7 Operator's Manual
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Masimo PRONTO-7 Operator's Manual

Spot check pulse co-oximeter
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Spot Check Pulse CO-Oximeter
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Summary of Contents for Masimo PRONTO-7

  • Page 1 Spot Check Pulse CO-Oximeter O P E R A T O R ’ S M A N U A L...
  • Page 3 These operating instructions intend to provide the necessary information for proper operation of the Masimo Rainbow ® SET ® Pronto-7™ Pulse CO-Oximeter. General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of the Pronto-7 are prerequisites for proper use.

  • Page 4: Safety Information, Warnings And Cautions

    S a f e t y I n f o r m a t i o n , W a r n i n g s a n d C a u t i o n s The Pronto-7 is designed to minimize the possibility of hazards from errors in the sofware program by following sound engineering design processes, Risk Analysis and Software Validation.
  • Page 5 As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. ■ Do not place the Pronto-7 or accessories in any position that might cause it to fall on the patient. Do not lift the Pronto-7 by the cable or sensor. ■...
  • Page 6 EMI radiation interference ❚ Motion artifact ■ Do not place the Pronto-7 against a surface. This can cause the a system or battery (non- clinical) alarm to be muffled. ■ Additional information specific to the Masimo Rainbow PDC-SC reusable sensor including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's Directions For Use (DFU).
  • Page 7 ■ A functional tester cannot be utilized to assess the accuracy of the Pronto-7 or its PDC-SC reusable sensor. ■ Cleared Use Only: The device and related accessories are cleared by the Food and Drug...
  • Page 8 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...

  • Page 9: Table Of Contents

    General Description..................1-4 SpHb General Description ..................1-4 Principles of Operation ..................... 1-5 Functional Saturation ....................1-5 Pronto-7 vs. Drawn Whole Blood Measurements ............. 1-5 SpHb Measurements During Patient Motion ............1-6 SECTION 2 - SYSTEM DESCRIPTION Introduction ......................... 2-1 Front Panel and Touchscreen ....................
  • Page 10 Specifications ........................7-1 SECTION 8 - SENSOR Introduction .......................... 8-1 Masimo Rainbow PDC-SC (Pronto-7 Direct Connect-Spot Check) Reusable Sensor ..8-2 Sensor Accuracy ...................... 8-2 Cleaning And Reuse of a Masimo Reusable Sensor ..........8-2 SECTION 9- SERVICE / MAINTENANCE Introduction ..........................

  • Page 11: 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 Pronto-7. Important safety information relating to general use of the instrument appears before this introduction. Other important safety information is located throughout the manual where appropriate.

  • Page 12: Warnings, Cautions And Notes

    CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A Note is provided when extra general information is applicable. Note: This is a sample of a Note. Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...

  • Page 13: Product Description

    Print and email options INDICATIONS FOR USE The Masimo Rainbow SET Pronto-7 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 Pronto-7 Pulse...

  • Page 14: Pulse Co-Oximeter

    Sensor SpHb GENERAL DESCRIPTION Instruments containing Masimo Rainbow SET Technology offer a non-invasive method of measuring the levels of total hemoglobin in blood (SpHb). It relies on the same principles of pulse oximetry to make SpHb measurements. The measurements are taken by placing a sensor on a patient, usually on the fingertip for adults as shown in the figure above.

  • Page 15: Principles Of Operation

    (SpHb [g/dl]). The SpHb measurement relies on a multiwavelength calibration equation to quantify the percentage of total hemoglobin in blood. In an ambient temperature of 95º F (35º C) the maximum skin surface temperature has been measured at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure.
  • Page 16 If this bar fills completely the test will not be able to complete. (See example below) motion bar A Test Incomplete message will display with information describing the problem encountered and if any corrective course of action is needed. Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...

  • Page 17: Introduction

    A Masimo Rainbow Pronto-7 Direct Connect-Spot Check (PDC-SC) reusable sensor attaches to the top of the Pronto-7. The Pronto-7 is powered by a rechargeable lithium polymer battery. F r o n t P a n e l a n d T o u c h s c r e e n...

  • Page 18: Front Panel And Touchscreen Details

    Serial Number BACK PANEL DETAILS Certification Label The instrument’s certification marks are displayed. Serial Number This number can be used to uniquely identify the instrument and will be needed if Masimo Service is called. Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...

  • Page 19: Bottom Panel

    AC power outlet. Use only the included power cable. Spot check tests can be run while the power cable is plugged into an outlet. Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...

  • Page 20: Symbols

    S y m b o l s The following symbols may be found on the Pronto-7 or packaging and are defined below: SYMBOL...

  • Page 21: Introduction

    I n t r o d u c t i o n Before the Pronto-7 can be used, it needs to be inspected, properly setup and have the battery fully charged. 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 22: Preparation For Use

    To see if the PDC-SC reusable sensor contains spot check credits, connect it to a Pronto-7. A numeric value will appear in the top left corner of the screen, next to the Masimo icon, with the number of available spot check credits it contains (e.g. 200).

  • Page 23: Pronto-7 Operation

    If a sensor is not attached or not connected completely, this screen displays: Attach a sensor and continue with step 4. When a sensor is attached, the following screen displays and testing can begin Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...
  • Page 24 If the test needs to be interrupted, press After a successful test there will be an audible tone and the results screen will display: Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...

  • Page 25: Test Results

    Incomplete Test An incomplete test can occur due to excessive motion, interference to the instrument or if was pressed. The examples below show incomplete test message screens. Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...

  • Page 26: Ensuring A Successful Spot Check

    ■ Read the sensor's Directions for Use for proper sensor application. MASIMO SENSORS Before use, carefully read the Masimo Rainbow PDC-SC reusable sensor's Directions for Use. Use only a PDC-SC reusable sensor for spot checking measurements. CAUTIONS ■ DO NOT USE DAMAGED SENSORS. DO NOT USE A SENSOR WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS.

  • Page 27: Numeric Display - Pulse Rate

    Hemoglobin synthesis disorder. NUMERIC DISPLAY - PULSE RATE The Pulse Rate displayed on the Pronto-7 may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation.

  • Page 28: Main Menu Screen

    On, Off Voice On, Off Settings Date & Time Clock Display On, Off 12 hour 12 hour, 24 hour Time Format hh/mm/pm user editable Time Date Format yy/mm/dd yy/mm/dd, mm/dd/yy, dd/mm/yy user editable Date Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...
  • Page 29 (About Owner screen) User Name enter Masimo server name Password enter Masimo server password Attach Image (test Yes, No screen shot) Attach .CSV (.csv Yes, No data file) Bluetooth Pairing On, Off Bluetooth (2.0) Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...
  • Page 30 Contact Tech Support Masimo Tech Support contact information Device Serial #, Software Version, Total Device Run Time, Last Service/ Equipment Report which Location, Sensor Serial #, Total Sensor Run Time, Spot Checks Obtained, includes: Event History Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...
  • Page 31 BATTERY LEVEL INDICATOR The Pronto-7 is powered by a rechargeable lithium polymer battery. It can also be powered by AC power, when used with the included AC power cable. Battery charge level is indicated by the battery icon in the upper right hand corner of the touchscreen.
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  • Page 33: Messages

    M e s s a g e s The Pronto-7 will indicate other data or system errors. Message conditions follow: MESSAGE TYPE SOLUTION Initiate spot check by pressing the green Ready Ready for spot check "Test"...
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  • Page 35: Troubleshooting

    T r o u b l e s h o o t i n g The following chart describes what to do if the Pronto-7 system does not operate properly or fails. PROBLEM...
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  • Page 37: Specifications

    500 mbar to 1060 mbar pressure Operating altitude -1000 ft to 18,000 ft (-304 m to 5,486 PHYSICAL CHARACTERISTICS 5.1” x 2.8” x 1” (13cm x 7.2cm x 2.5 cm) Dimensions 10.5 oz (296.4 g) Weight Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...
  • Page 38 Plus or minus one standard deviation encompasses 68% of the population weight. 2. Masimo sensors have been validated for pulse rate accuracy for the range of 30-250 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 39: Section 8 - Sensor

    Do not attempt to reprocess, recondition or recycle any Masimo sensors as these processes may damage the electrical components, potentially leading to patient harm. ■ The PDC-SC reusable sensor is designed for use with the Pronto-7. Verify the compatibility of the instrument and sensor before use, otherwise patient injury can result. ■...

  • Page 40: Masimo Rainbow Pdc-Sc (Pronto-7 Direct Connect-Spot Check) Reusable Sensor

    Complete accuracy specifications are located in the sensor's DFU and are specific for the type of Masimo sensor used. CLEANING AND REUSE OF A MASIMO REUSABLE SENSOR Reusable Rainbow sensors can be cleaned per the following procedure: Remove the sensor from the patient.

  • Page 41: Introduction

    C l e a n i n g The outer surface of the Pronto-7 can be cleaned with a soft cloth dampened with a mild detergent and warm water solution. Do not allow liquids to enter the interior of the instrument. The outer surface of the instrument can also be wiped down using the following solvents: Cidex Plus (3.4%...

  • Page 42: Ordering Spot Check Credits

    Using a MicroSD card to load spot check credits* Connect the PDC-SC reusable sensor to the Pronto-7 instrument. Take the MicroSD card with spot check credits on it and insert it into the Pronto-7 MicroSD card slot. After a few seconds, look in the upper left hand corner of the instrument's display to verify the number of credits now available on your sensor.

  • Page 43: 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 to request an RMA number. Package the equipment securely – in the original shipping container if possible – and enclose or include the following information and items: ■...
  • Page 44 Tel: 03 3237 3057, FAX: 03 3238 1110 For Europe: Masimo International Sàrl Puits-Godet 10 2000 Neuchatel - SWITZERLAND Tel: +41 32 720 1111 Fax.: +41 32 724 1448 All other locations: Contact your local Masimo Representative Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter...

  • Page 45: Sales & End-User License Agreement

    W a r r an ty 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 46: End-User License

    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 47: No Implied License

    Masimo. There is no license, implied or otherwise, that would allow use of licensed sensors beyond their intended duration. After use of sensors through their designated duration, there is no further license granted by Masimo to use the sensors and the sensors must be discarded or returned to Masimo for reprocessing.
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  • Page 50 www.masimo.com...

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