Masimo Pronto-7 Operator's Manual
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Masimo Pronto-7 Operator's Manual

Masimo Pronto-7 Operator's Manual

Spot chek pulse co-oximeter
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DRAFT 02 17 14
Pronto-7
Operator's Manual

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  • Page 1 DRAFT 02 17 14 Pronto-7 Operator's Manual...
  • Page 3 Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter, also referred to as Pronto-7, operating instructions provide the necessary information for proper operation of Pronto-7. There may be information provided in this manual that is not relevant for your system. Do not operate Pronto-7 without completely reading and understanding the instructions in this manual.
  • Page 4 © 2014 Masimo Corporation. www.masimo.com Masimo...

  • Page 5: Table Of Contents

    Signal Extraction Technology (SET) -------------------------------------------- 1515 rainbow Pulse CO-Oximetry Technology -------------------------------------- 1515 Functional Oxygen Saturation ---------------------------------------------------- 1616 Pronto-7 vs. Drawn Whole Blood Measurements --------------------------- 1616 Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods* --------------------------------------------------------------- 1717 Chapter 2: Product Description------------------------------------------------------...
  • Page 6 Chapter 6: Troubleshooting ---------------------------------------------------------- 6359 Troubleshooting ---------------------------------------------------------------------- 6359 Chapter 7: Specifications ------------------------------------------------------------- 6561 Specifications ------------------------------------------------------------------------- 6561 Calibration Verification ------------------------------------------------------------- 6864 Symbols -------------------------------------------------------------------------------- 6864 Chapter 8: Service and Repair ------------------------------------------------------ 7167 Service and Repair ------------------------------------------------------------------ 7167 Index --------------------------------------------------------------------------------------- 7973 www.masimo.com Masimo...

  • Page 7: About This Manual

    WARNING: This is an example of a warning statement. A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to Pronto-7 or damage to other property. The following is an example of a caution: CAUTION: This is an example of caution statement.

  • Page 9: Product Description

    The instrument is voice automated, provides step by step instructions when administering tests and is equipped with an interactive touchscreen for user selectable options. Contraindications The Pronto-7 is contraindicated for use as an apnea monitor. The Pronto-7 is also contraindicated for use as a continuous monitor. www.masimo.com Masimo...

  • Page 11: Safety Information, Warnings, And Cautions

    Safety Information, Warnings, and Cautions The following section lists warnings, cautions, notes, and safety information for Pronto-7. Pronto-7 is to be operated by qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. www.masimo.com...

  • Page 12: Safety Information, Warnings, And Cautions

    Safety Information, Warnings, and Cautions Safety Information, Warnings, and Cautions Always use the Pronto-7 precisely in accordance with the directions in this manual, including finger selection, finger alignment in the sensor, and subject behavior during testing. Failure to follow all of the directions in this manual could lead to inaccurate measurements.
  • Page 13 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 14: Compliance Information, Warnings And Cautions

    Excessive moisture can cause the instrument to perform inaccurately or fail. Do not place containers with liquids on or near the Pronto-7. Liquids spilled on the instrument may cause it to perform inaccurately or fail. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
  • Page 15 This Class B digital apparatus complies with Canadian ICES-003. Do not open the Pronto-7 instrument. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment.

  • Page 16: Sensor Information, Warnings And Cautions

    Safety Information, Warnings, and Cautions Sensor Information, Warnings and Cautions If using the Pronto-7 during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the instrument might read zero for the duration of the active irradiation period.

  • Page 17: Chapter 1: Technology Overview

    Chapter 1: Technology Overview Signal Extraction Technology (SET) Masimo Signal Extraction Technology's signal processing 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, however, the venous blood also moves, causing...

  • Page 18: Functional Oxygen Saturation

    This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25mW. The detectors receive the light, convert it into an electronic signal and send it to the Pronto-7 for calculation. Once the Pronto-7 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient's functional oxygen saturation (%SpO total hemoglobin concentration (SpHb [g/dL]) and pulse rate (BPM).

  • Page 19: Non-Invasive Total Hemoglobin (Sphb) Accuracy Compared To Invasive

    Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods* The following is data of the sensor compatible with the Pronto-7: Rainbow 4D DC Reusable Sensor. rainbow 4D DC Reusable Sensor For Normal Sensitivity Mode in 10,253 comparisons of SpHb® and invasive...

  • Page 21: Chapter 2: Product Description

    The Test Ready screen, as seen in the following image, indicates a compatible sensor has been properly inserted into the Pronto-7 and the instrument is ready for testing. The Main Menu icon, also available on the Test Ready screen, provides access to additional icons and user configurable options.

  • Page 22: Pronto-7 Front Panel And Touchscreen

    Pronto-7 Chapter 2: Product Description Pronto-7 Front Panel and Touchscreen www.masimo.com Masimo...
  • Page 23 Description Places instrument in Power Power On/Off On and Power Off modes. Provides an interface for LCD Touchscreen user interactions. Indicates Pronto-7 is ready Test Ready Screen for testing. Provides connectivity for Connector Port rainbow 4D DC sensors. Time Displays instrument's time.

  • Page 24: Pronto-7 Back Panel

    Pronto-7 Chapter 2: Product Description Pronto-7 Back Panel Ref. Feature Description Certification Documents the instrument’s certification marks. Label Serial Number Lists unique serial number associated with the instrument. www.masimo.com Masimo...

  • Page 25: Pronto-7 Bottom Panel

    Mini USB Port Input port for mini USB cable to computer connection. Power Port Power supply connector for the Pronto-7 specific power cable. Parameter and Measurement Descriptions Total Hemoglobin (SpHb) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood.
  • Page 26 Pronto-7 Chapter 2: Product Description Arterial Oxygen Saturation (SpO2) Pulse oximetry is a noninvasive method of measuring the level of functional arterial oxygen saturation in blood. The instrument displays the calculated data as a percent value for functional arterial oxygen saturation (SpO...

  • Page 27: Chapter 3: Setup

    If anything is missing or damaged, contact the Masimo Technical Service Department, see Return Procedure on page 7369. Preparation for Use Before the Pronto-7 can be used, it needs to be properly setup and fully charged. Note: The initial battery charge can take up to 6 hours.

  • Page 29: Chapter 4: Operation

    Chapter 4: Operation The information in this chapter assumes that Pronto-7 is set up and ready for use. Do not operate the Pronto-7 without completely reading and understanding these instructions. The following sections describe how the Pronto-7 information is displayed, including available parameters, icons, features and accessing user configurable settings.

  • Page 30: Common Screens

    Chapter 4: Operation Common Screens Item Description Connect Sensor screen indicates a compatible sensor should be properly connected to the Pronto-7 in order to begin testing. Test Ready screen indicates the Pronto-7 is ready for testing. Test Results screen provides parameter and measurement test results.
  • Page 31 Pronto-7 Chapter 4: Operation Icons Description Starts a test. Provides access to additional icons and user configurable settings. Submits inputs and exits the Main Menu. Moves back one screen. Pressing and holding returns to Test Ready screen. Exits pop-up windows.

  • Page 32: Recommended Initial Testing Procedure

    Pronto-7 Chapter 4: Operation Icons Description Adds patient specific information. Discontinues test. Recommended Initial Testing Procedure SpHb Spot Check Measurement Note: Potentially inaccurate results can occur if the user does not properly follow the testing procedure. As with any diagnostic test, clinicians should always evaluate hemoglobin measurements in the perspective of the clinical context of the patient.
  • Page 33 Pronto-7 Chapter 4: Operation Sensor Selection Pronto-7 is compatible with rainbow 4D DC sensors, which has three sizes: large, medium and small. Use the Finger Size Guide attached to the sensor to ensure the correct sensor is being used. Measure the patient’s finger size (diameter) at the cuticle to determine the correct sensor size using the Finger Size Guide.
  • Page 34 Use a light shield to cover the sensor from ambient light interference. Do not perform measurements in environments with high ambient light or in front of monitors as incomplete tests may occur. In these environments, a Masimo ambient light shield should be used to limit the effect on the measurement www.masimo.com...

  • Page 35: Patient Testing

    Pronto-7 Chapter 4: Operation Patient Testing Note: The patient should be in a seated position for 2-3 minutes prior to, and during testing. Do not allow the patient to talk, laugh, cough or move during testing. If this occurs, stop and re-test.
  • Page 36 Pronto-7 Chapter 4: Operation If motion is detected, a hand icon will appear at the bottom right side of the screen. (If the motion is not stopped and Measure Through Low SIQ is not on, the test may be incomplete, in some cases, a measurement can be displayed despite low signal quality conditions).

  • Page 37: Completed Test

    Pronto-7 Chapter 4: Operation Completed Test After a successful spot check test, parameters may be seen on the Test Results screen. Additional parameters may be seen by tapping the icon when available. Detailed information about the patient can be entered by pressing the icon.

  • Page 38: Incomplete Test

    For troubleshooting, see Chapter 6: Troubleshooting on page 6359. Key Features The following section details some of the features available on the Pronto-7. See Main Menu Options on page 5147 for additional features.
  • Page 39 Pronto-7 Chapter 4: Operation Viewing Select Parameters Upon successful completion of a spot check test, the default parameters shown on the firs page of the Test Results screen are SpHb, SpO , PR, and If the user would like the Test Results screen to display specific parameters, on page 2, perform the following: Tap the Main Menu icon.
  • Page 40 Chapter 4: Operation Low Signal I.Q. (Low SIQ) The Pronto-7 provides a visual indication of low signal quality by displaying, as seen in the following image, a Low SIQ icon at the bottom of the screen during a measurement when the displayed waveforms are based on inadequate signal quality.
  • Page 41 Measure through Motion, identified on the Pronto-7 screen as measure under Low SIQ. If any of the three sensitivity modes are toggled to On, the Pronto-7 will remain in the test mode until the user manually configures the mode to Off, or if SpO only test mode is turned On, as this test mode overrides all sensitivity modes.
  • Page 42 Motion Test Mode accuracy over 6-18 g/dL: ± 1.1 accuracy g/dL Normal over any Default mode for Pronto-7 range is ± 1.5 accuracy g/dl over 8-17 g/dL: ± 1.0 g/dL MAX sensitivity mode accuracy accuracy should provide less “Test over 4.5-20...
  • Page 43 Pronto-7 Chapter 4: Operation Accuracy Accuracy under under no Measure Mode Notes motion Through conditions Motion Test Mode When SpO Only mode is accuracy On, Normal, Max and Multi over 6-18 sensitivity modes will be g/dL: ± 1.1 accuracy overridden. SpHb...
  • Page 44 To test in multi sensitivity mode upon successful completion of a spot check test: Tap the Multi icon to transition into multi test mode. The Pronto-7 will direct you to complete the following steps: • Remove the sensor completely.
  • Page 45 Pronto-7 Chapter 4: Operation Accessing SpHb in SpO2 Only Test Mode SpHb is needed after the SpO only mode test is complete the user can access SpHb, which will deduct a test credit. To access SpHb in this mode, the user can tap the SpHb icon on the left side of the screen.
  • Page 46 If registration is successful, your user name and password information is saved. Retain this information for your records. Configuring Outgoing Email Settings From the Main Menu on the Pronto-7, navigate to the Connections icon. From the Connections icon, navigate to the Outgoing Email screen.
  • Page 47 Pronto-7 Chapter 4: Operation Tap the Accept icon. www.masimo.com Masimo...
  • Page 48 To download spot check tests directly using the Pronto-7, the instrument must be connected to a wireless network. There are two ways to access wireless download of spot check tests, either from the Main Menu icon or the radical sign.
  • Page 49 Pronto-7 Chapter 4: Operation Features / Step Description Display Tests Number of tests remaining on the connected sensor. Remaining Number of tests purchased and available for Tests Available download. Quickload Selectable shortcuts to download preset quantities of Tests tests (10, 25, 50, 100, 250 or 500 tests).
  • Page 50 Using a Micro_SD Card: Connect a compatible sensor to the Pronto-7. Insert the micro SD card with spot check tests on it into the Pronto-7 micro SD card slot. Tap the Main Menu icon on the Test Ready screen.
  • Page 51 (one on the micro SD and one on the Internal Device Storage) the Pronto-7 will only allow you to load the oldest files. After the oldest file is loaded, then the next most recent spot check test file can be loaded.
  • Page 52 Populate the Server and Port settings depending on the specific EMR setup on-site. Tap the green check mark icon to accept changes. After each complete spot check test the file will be uploaded to the EMR. Consult Masimo Technical Services for EMR connectivity support and maintenance. www.masimo.com Masimo...

  • Page 53: Main Menu Options

    Pronto-7 Chapter 4: Operation Main Menu Options The following section outlines all Main Menu features available on the Pronto-7 and user configurable options. Main Menu Access To access the Main Menu: from any screen where it is shown. The Main Menu icon allows access to the following icons.
  • Page 54 Pronto-7 Chapter 4: Operation Test Results Icon The test results icon provides the date of patient testing, the patient ID and the results produced. Sortable by column, data can be rearranged by pressing the column header to sort. The data cannot be sorted by Results.
  • Page 55 User selectable (SSID, Security On, Off, encryption key WEP64, WEP-128, New Network WPA-TKIP, WPA2-AES, Network password key) Outgoing Email User Name Enter Masimo server name Password Enter Masimo server password Reply to Address N/A User editable (About Owner screen) www.masimo.com Masimo...
  • Page 56 Pronto-7 Chapter 4: Operation Factory Option Configurable Settings Default Attach Image Yes, No (test screen shot) Attach .CSV Yes, No (.csv data file) Bluetooth Pairing Bluetooth (2.0) On, Off Security (if On, Off Bluetooth is On) Printer Configuration Printer Address...
  • Page 57 Pronto-7 Chapter 4: Operation Device Diagnostics Icon Option Factory Default Configurable Setting Interference Scan N/A Check Environment for Interference Display Icon Option Factory Default Configurable Settings Brightness 1 - 10 SpHb Units of Measure g/dL g/dL, g/L, mmol/Ls, SpHct (%)
  • Page 58 On, Off Time Format 12 hour 12 hour, 24 hour Time hh/mm/pm User editable Date Format mm/dd/yy yy/mm/dd, mm/dd/yy, dd/mm/yy Date User editable Power Save Mode Power Save Mode On On, Off About Pronto-7 /Owner About Pronto-7 Masimo Contact www.masimo.com Masimo...
  • Page 59 Supplies access to erase all measurements and Clear Database patient/user database Allows download of latest configurations of Pronto-7 that is Device available, displays a list of features enabled based on www.masimo.com Masimo...

  • Page 60: Battery

    Battery 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 LCD touchscreen.
  • Page 61 Pronto-7 Chapter 4: Operation Checking Battery Status Tap the battery icon at any time to see the current battery status. www.masimo.com Masimo...

  • Page 63: Chapter 5: Alarms And Messages

    Chapter 5: Alarms and Messages Messages The Pronto-7 will indicate other data or system errors. Messages are: Message Possible Indication Recommendation Initiate spot check test by Ready Ready for spot check test pressing the green Test icon. Connect No compatible sensor is...

  • Page 65: Chapter 6: Troubleshooting

    Chapter 6: Troubleshooting Troubleshooting The following chart describes what to do if the Pronto-7 system does not operate properly or fails. Problem Possible Recommendation(s) Sources Ensure sensor is placed on a well perfused site. Make sure the patient's finger is all...
  • Page 66 Connection computer. included USB cable issue does not recognize If the Pronto-7 still does not appear, the Pronto-7 search your computer's User Manual for proper external drive mapping and troubleshooting. Turn off the instrument and then Touchscreen icons power it on.

  • Page 67: Chapter 7: Specifications

    4.5 - 20 g/dL: ± 1.1 g/dL Note: For all sensitivity modes under motion, A accuracy over any range is ± 1.5 g/dL. Resolution SpHb (total hemoglobin) 0.1 g/dL PR (pulse rate) 1 bpm (Arterial Oxygen Saturation) www.masimo.com Masimo...
  • Page 68 Pronto-7 Chapter 7: Specifications PI (perfusion index) 0.01% SpHct Interfering Substances Refer to Safety Information, Warnings, and Cautions on page 99. Product Test storage capacity 8000 Wireless connectivity 802.11 b/g, Bluetooth Reporting modes Print, email, audible, micro SD Report formats...
  • Page 69 Pronto-7 Chapter 7: Specifications Storage Temperature -40° F to 158° F (-40° C to 70° C) Operating Humidity 5% to 95%, non-condensing 500 mbar to 1060 mbar Operating Altitude -1000 ft to 18,000 ft (-304 m to 5,486 m) Physical Characteristics 5.1"...

  • Page 70: Calibration Verification

    In this case, contact your Masimo representative and return the device for service. Symbols The following symbols may be found on the Pronto-7 or packaging and are defined below: Symbol Description Caution, consult accompanying documents www.masimo.com...
  • Page 71 Pronto-7 Chapter 7: Specifications Symbol Description Follow Instructions for Use Type BF applied part complying with IEC 60601-1 Separate collection for electrical and electronic equipment (WEEE) Mark of Conformity to European Medical Device Directive 93/42/EEC Federal law restricts this device to sale by or on the order of a...
  • Page 72 Pronto-7 Chapter 7: Specifications Symbol Description MDSS GmbH, Schiffgraben 41, D-30175 Hannover, Germany Manufacturer Wireless features can be used in member states with the restriction of indoor use in France Federal Communications Commission (FCC) licensing Non-ionizing electromagnetic radiation Protection against vertically falling water drops No parameter alarms www.masimo.com...

  • Page 73: Chapter 8: Service And Repair

    The Pronto-7 is a reusable instrument. The instrument is supplied non-sterile. Cleaning 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.
  • Page 75 5147 ). Please clean contaminated/dirty equipment (See Cleaning on page 7167) before returning and make sure it is fully dry before packing the equipment. Call Masimo Technical Services to request return authorization (RMA), at the phone number below. Package the equipment securely – in the original shipping container if possible –...
  • Page 76 Product. If you do not agree to the terms of this agreement, promptly return the entire Product, including all accessories, in their original packages, with your sales receipt to Masimo for a full refund. www.masimo.com...
  • Page 77 Chapter 8: Service and Repair Warranty Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: each new Product and the Software media as delivered are free from defects in workmanship or materials.
  • Page 78 Masimo shall not be liable for any incidental, special or consequential loss, damage or expense directly or indirectly arising from the use or loss of use of any Products or Software. In no event shall Masimo’s liability arising from any Product and Software (under contract, warranty, tort, strict liability or other claim) exceed the amount paid by purchaser for the Products giving rise to such claim.
  • Page 79 Software License as set forth herein. This Software is proprietary and owned by Masimo or its third party suppliers and can be used solely in connection with the monitor described herein.
  • Page 80 Sensors Licensed for Monitoring Use Only Sensors designated for monitoring only are licensed to you under patents owned by Masimo to be used for patient monitoring, in an unmodified form as originally received from Masimo, and no license is granted to have Masimo’s sensors reprocessed or otherwise modified, unless specifically authorized by Masimo.

  • Page 81: Index

    Hematocrit (SpHct) • 24 Alarms and Messages • 57 Chapter 6 Troubleshooting • 34, 59 Chapter 7 Incomplete Test • 34 Specifications • 61 Indications for Use • 7 Chapter 8 Introduction • 67 Service and Repair • 67 www.masimo.com Masimo...
  • Page 82 Pronto-7Pronto-7 Index Pronto-7 vs. Drawn Whole Blood Measurements • 16 Key Features • 35 Pulse Rate (PR) • 24 Low Battery Alarm • 55 rainbow 4D DC Reusable Sensor Low Signal I.Q. (Low SIQ) • 33, 36 • 17 rainbow Pulse CO-Oximetry Technology •...
  • Page 83 Total Hemoglobin (SpHb) • 23 Troubleshooting • 59 Unpacking and Inspection the System • 25 Using a Micro_SD Card: • 44 Using a USB Cable: • 45 Viewing Select Parameters • 35 Viewing SpHct • 35 Warranty • 70 www.masimo.com Masimo...
  • Page 88 33492/LAB-5621S 0214...

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