Operators Manual
60 Pages
Preview
Page 1
Spot Check Pulse CO-Oximeter
Operator’s Manual
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. Do not operate the Pronto-7 without completely reading and understanding these instructions.
Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents. CAUTION: FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. For further information contact: Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU Authorized Representative for Masimo Corporation:
EC
REP
MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany
3148433 Covered by one or more of the following U.S. Patents: 5919134; 6002952; 6067462; 6229856; 6388240; 6463311; 6606511; 6643530; 6684090; 6699194; 6816741; 6961598; 6979812; 7003339; 7044918; 7186966; 7215984; 7215986; 7221971; 7254433; 7489958; 7496393; 7596398; D621516; D606659; international equivalents, or one or more of the patents referenced at www.masimo.com/patents.htm. Other patents pending. Masimo, , PVI, Signal Extraction Pulse CO-Oximeter, rainbow and Signal IQ are registered trademarks of Masimo Corporation. Pronto-7, SIQ and SpHb are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. Printed in USA © 2011 Masimo Corporation.
Masimo Pronto-7 Pulse CO-Oximeter i
Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods* For Normal Sensitivity Mode in 11,335 comparisons of SpHb and invasive hemoglobin (tHb) measurements from a laboratory reference device, SpHb accuracy was as follows: ■■ 0.89 correlation ■■ 0.99 g/dL Arms accuracy ■■ Between 6 - 12 g/dL, greater than 95% of SpHb readings were within 2 g/dL of the laboratory tHb value ■■ Between 12 - 18 g/dL, greater than 95% of SpHb readings were within 2 g/dL of the laboratory value For Maximum (MAX) Sensitivity Mode in 12,622 comparisons of SpHb and invasive hemoglobin (tHb) measurements from a laboratory reference device, SpHb accuracy was as follows: ■■ 0.88 correlation ■■ 1.1 g/dL Arms accuracy ■■ Between 4.5 - 12 g/dL, greater than 90% of SpHb readings were within 2 g/dL of the laboratory tHb value ■■ Between 12 - 20 g/dL, greater than 95% of SpHb readings were within 2 g/dL of the laboratory value * Masimo FDA Submission Data.
CONTRAINDICATIONS: The Pronto-7 is contraindicated for use as an apnea monitor. The Pronto-7 is also contraindicated for use as a continuous monitor. Safety Information, Warnings and Cautions 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. ■■ The Pronto-7 is to be operated by qualified personnel only. This manual, accessories, Directions for Use, all precautionary information, and specifications should be read before use. ■■ Variation in hemoglobin measurements may be profound and may be affected by sample type, body positioning, as well as other physiological conditions. As with most hemoglobin tests, Pronto-7 test results should be scrutinized in light of a specific patient’s condition. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data. ■■ Explosion hazard. Do not use the Pronto-7 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. ■■ Electric shock hazard. 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. ■■ High intensity extreme lights (including pulsating strobe lights and direct sunlight) directed on the sensor, may not allow the Pronto-7 to obtain readings. ■■ EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause errors or incorrect measurements on the Pronto-7.
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Masimo Pronto-7 Pulse CO-Oximeter
Safety Information, Warnings and Cautions, continued
■■ The Pronto-7 should be considered an early warning device. For measurements of high or low SpHb readings, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition. ■■ If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to completely understand the patient’s condition. ■■ Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The Pronto-7 should not be used as a replacement or substitute for ECG based arrhythmia analysis. ■■ 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. ■■ Patient Safety - If a sensor is damaged in any way, discontinue use immediately. ■■ Always remove the sensor from the patient and completely disconnect the patient from the Pronto-7 before bathing the patient. ■■ Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. ■■ Do not use the Pronto-7 or sensor during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Pronto-7 may affect the MRI image and the MRI device may affect the accuracy of the Pulse CO-Oximetry parameters and measurements. ■■ Do not use the Pronto-7 during electrocautery. ■■ Do not use the Pronto-7 or sensor during defibrillation. ■■ 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. ■■ Do not place the Pronto-7 where the controls can be changed by the patient. ■■ Do not place the Pronto-7 on electrical equipment that may affect the instrument, preventing it from working properly. ■■ Do not expose the Pronto-7 to excessive moisture such as direct exposure to rain. 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. ■■ SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). The Pulse CO-Oximeter cannot measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement. ■■ Failure to apply the sensor properly may lead to incorrect measurements. ■■ Do not loop the sensor cable into a tight coil or wrap around the device, as this can damage the sensor cable. Masimo Pronto-7 Pulse CO-Oximeter
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Safety Information, Warnings and Cautions, continued
■■ Inaccurate SpO2 readings may be caused by: ❚❚ Elevated levels of COHb and MetHb ❚❚ For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level of increase is approximately equal to the amount of COHb that is present. ❚❚ NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
❚❚ For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read in the low to mid 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 and texture such as nail polish, acrylic nails, glitter, etc. ❚❚ Elevated levels of bilirubin ❚❚ Severe anemia ❚❚ Low arterial perfusion ❚❚ Motion artifact ■■ Inaccurate SpHb readings may be caused by: ❚❚ Intravascular dyes such as indocyanine green or methylene blue ❚❚ Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc. ❚❚ Elevated levels of bilirubin ❚❚ Low arterial perfusion ❚❚ Motion artifact ❚❚ Low arterial oxygen saturation levels ❚❚ Elevated carboxyhemoglobin levels ❚❚ Elevated methemoglobin levels ❚❚ Difference between patient's finger skin and finger core temperature ❚❚ Hemoglobin synthesis disorders ❚❚ Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. ❚❚ Vasospastic disease such as Raynaud's ❚❚ Elevated altitude ❚❚ Peripheral vascular disease ❚❚ Liver disease ❚❚ EMI radiation interference ■■ Additional information specific to the Masimo Rainbow 4D DC reusable sensor including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's Directions For Use (DFU). iv
Masimo Pronto-7 Pulse CO-Oximeter
Safety Information, Warnings and Cautions, continued
■■ 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. ■■ For best test results, perform testing only after the patient and instrument have acclimated to the ambient temperature in which the test is to be performed. ■■ Do not expose the Rainbow 4D DC reusable sensor to moisture, liquids or a humid environment, as this may make the sensor perform inaccurately or fail. ■■ If the Pronto-7 fails any part of the setup procedures or leakage spot check, remove the instrument from operation until qualified service personnel have corrected the situation. ■■ Use the Pronto-7 in accordance with Section 7, Environmental Specifications in of this manual. ■■ Do not incinerate battery. ■■ To protect against injury from electric shock, follow the directions below: ❚❚ Avoid placing the device on surfaces with visible liquid spills. ❚❚ Do not soak or immerse the device in liquids. ❚❚ Use cleaning solutions sparingly. ■■ This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. ■■ This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ❚❚ Reorient or relocate the receiving antenna. ❚❚ Increase the separation between the equipment and receiver. ❚❚ Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. ❚❚ Consult the dealer or an experienced radio/TV technician for help. ■■ In accordance with international telecommunication requirements, the frequency band of 2.4 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. ■■ 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. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. ■■ A functional tester cannot be utilized to assess the accuracy of the Pronto-7 or its Rainbow 4D DC reusable sensor. Masimo Pronto-7 Pulse CO-Oximeter
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Safety Information, Warnings and Cautions, continued
■■ Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the FDA, or in any manner inconsistent with the instructions for use or labeling. The device and related accessories are not intended for use in combination with other medical devices or in high-risk applications. ■■ 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.
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Masimo Pronto-7 Pulse CO-Oximeter
Table of Contents
Safety Information, Warnings and Cautions... ii About this Manual...1-1
Section 1 - Overview Warnings, Cautions and Notes...1-2 Product Description...1-3 Features and Benefits...1-3 Indications for Use ...1-3 Pulse CO-Oximeter...1-4 SpO2 General Description...1-4 SpHb General Description...1-4 Principles of Operation...1-5 Functional Oxygen Saturation...1-6 Pronto-7 vs. Drawn Whole Blood Measurements...1-6 Measurements During Patient Motion...1-6
Section 2 - System Description Introduction ...2-1 Front Panel and Touchscreen...2-1 Front Panel and Touchscreen Details...2-1 Back Panel...2-2 Back Panel Details...2-2 Bottom Panel ...2-3 Bottom Panel Details...2-3 Power Port...2-3 Symbols...2-4
Section 3 - Setup Introduction...3-1 Unpacking and Inspection...3-1 Commonly Used Buttons...3-1 Preparation for Use...3-2 Introduction...3-2 Initial Setup...3-2 Spot Check Test System...3-2
Section 4 - Operation Pronto-7 Operation...4-1 Connecting and Testing ...4-1 Patient Testing...4-2 Test Results...4-3 Ensuring a Successful Spot Check...4-4 Masimo Sensors...4-4 Numeric Display - SpO2...4-5 Numeric Display - SpHb...4-5 Numeric Display - Pulse Rate...4-5 Numeric Display - PI...4-6 Low Perfusion...4-6 Low Signal I.Q. (Low SIQ)...4-6 Masimo Pronto-7 Pulse CO-Oximeter
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Table of Contents
Correct Sensor Placement...4-7 Main Menu Screen...4-9 Menu Options Table...4-9 Battery Level Indicator...4-12 Low Battery Alarm...4-12 Checking Battery Status ...4-12
Section 5 - Alarms / Messages Messages...5-1 Error Codes...5-1
Section 6 - Troubleshooting Troubleshooting...6-1
Section 7 - Specifications Specifications...7-1 Pronto-7 Accuracy Data...7-3 Normal Sensitivity Mode...7-3 Max Sensitivity Mode...7-8
Section 8 - Sensor Introduction...8-1 Masimo Rainbow 4D DC Reusable Sensor...8-2 Sensor Accuracy...8-2 Cleaning and Reuse of the Rainbow 4D DC Reusable Sensor...8-2
Section 9- Service and Repair Introduction...9-1 Cleaning...9-1 Ordering Spot Check Tests...9-2 Installing Spot Check Tests...9-2 Service and Repair...9-3 Repair Policy...9-3 Return Procedure...9-3 Sales & End-User License Agreement...9-4 Warranty...9-4 Exclusions...9-4 End-User License...9-5 Restrictions...9-5 No Implied License ...9-6 Sensors Licensed for Monitoring Use Only ...9-6
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Masimo Pronto-7 Pulse CO-Oximeter
Overview
1
About this Manual 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. Read the entire safety information section before you operate the instrument. In addition to the safety section, this manual includes the following sections: ■■ Section 1
Overview
■■ Section 2 System Description ■■ Section 3 Setup ■■ Section 4
Operation
■■ Section 5
Messages
■■ Section 6
Troubleshooting
■■ Section 7
Specifications
■■ Section 8
Sensor
■■ Section 9
Service and Repair
Masimo Pronto-7 Pulse CO-Oximeter
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1
Overview Warnings, Cautions and Notes Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: A WARNING is provided when actions may result in a serious outcome (i.e., injury, serious adverse affect, death) to the patient or user. Look for text in a box. WARNING: THIS IS A SAMPLE 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 this instrument or damage to other property. CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A Note is provided when additional general information is applicable. Note: This is a sample of a Note.
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Masimo Pronto-7 Pulse CO-Oximeter
Overview
1
Product Description The Masimo Pronto-7 Pulse CO-Oximeter (instrument) is developed to simultaneously and noninvasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb) and perfusion index (PI). The instrument has a single on/off button and an interactive touchscreen for administering tests along with user selectable options.
Features and Benefits Accurate and Non-invasive Measurement and Display of Functional Arterial Oxygen Saturation (SpO2) and Pulse Rate (PR) The instrument uses multiple wavelengths of light and proprietary algorithms to obtain functional arterial oxygen saturation (SpO2) and pulse rate (PR) readings. Total Hemoglobin (SpHb) The instrument measures total hemoglobin (SpHb) using similar principles as pulse oximetry with additional wavelengths of light and proprietary algorithms to obtain the measurements. Perfusion Index (PI) The instrument measures Perfusion Index (PI). This indicates arterial pulse signal strength. Useful Features Include: ■■ Lightweight, ergonomic handheld design ■■ Interactive color touchscreen interface ■■ Audible voice guided feedback ■■ Prompt spot check test results ■■ Test countdown timer ■■ Plethysmograph display ■■ Real time feedback of patient motion ■■ Review and sort previous test results ■■ Optional password protection for Spot check tests ■■ Optional input for patient identification number, name and other details ■■ Interference Scanner mode for detecting interference in testing environments ■■ 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 (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospitals, hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).
Masimo Pronto-7 Pulse CO-Oximeter
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1
Overview
Pulse CO-Oximeter
SpO2 General Description Pulse oximetry is a noninvasive method of measuring the level of functional arterial oxygen saturation in blood. The measurement is taken by placing a sensor 2 on a patient, usually on the finger for adults and pediatric patients. The sensor connects to the pulse oximetry instrument 1 . The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as a percent value for functional arterial oxygen saturation (SpO2).
Instrument
1 2
Sensor
SpHb General Description Pulse CO-Oximetry instruments 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 2 on a patient, usually on the finger as shown in the figure above. 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 grams/deciliter (g/dL) for SpHb (with different units of measure available in the display menu).
GR-16547B
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Masimo Pronto-7 Pulse CO-Oximeter
1
Overview Principles of Operation Pulse CO-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). Absorption Spectra 4.0
Carboxyhemoglobin
3.5
Oxyhemoglobin Methemoglobin
Absorption (1/mm)
Deoxyhemoglobin
3.0
Plasma
2.5 2.0 1.5 1.0 0.5 0 600
800
1000
1200
1400
1600
Wavelength (nm)
2. The amount of arterial blood in tissue changes with a person’s pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of blood changes as well. The Pronto-7 uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood and blood plasma. The Pronto-7 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to multiple photodiodes (detectors). See the figure below. Light-Emitting Diodes (LEDs) (7+ wavelengths) Detectors
Signal data is obtained by passing various visible and infrared lights (ranging from 500nm up to 1300nm) through a capillary bed (for example, a fingertip) and measuring changes in light absorption during the blood pulsatile cycle. 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 (%SpO2), total hemoglobin concentration (SpHb [g/dl]) and pulse rate (BPM). The SpHb measurement relies on a multiwavelength calibration equation to estimate the percentage of total hemoglobin in blood. In an ambient temperature of 95º F (35º C) the maximum GR-16535B
Masimo Pronto-7 Pulse CO-Oximeter
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Overview
1
skin surface temperature has been measured at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure.
Functional Oxygen Saturation The Pronto-7 is calibrated to measure and display functional oxygen saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. Refer to the Safety information, Warnings and Cautions section in front of this manual for details.
Pronto-7 vs. Drawn Whole Blood Measurements When SpO2 and SpHb measurements obtained from the instrument (noninvasive) are compared to drawn whole blood measurements (invasive) by blood gas and/or laboratory hematology, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratory hematology measurements may differ from the SpO2 and SpHb measurements of the Pronto-7. In the case of SpO2, different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. High levels of bilirubin may cause erroneous SpO2 and SpHb readings. As blood samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a meaningful comparison can only be achieved if the oxygen saturation, carboxyhemoglobin and mehemoglobin concentration of the patient are stable and not changing over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory hematology measurements of SpO2 and SpHb may vary with the rapid administration of fluids and in procedures such as dialysis. Additionally, drawn whole blood testing can be affected by sample handling methods and time elapsed between blood draw and sample testing.
Measurements During Patient Motion SpO2 and SpHb measurement accuracy may not be reliable during excessive motion because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion. When motion or low signal quality are detected during a test, the screen will display a hand icon at the bottom right side of the screen (See example below).
A Test Incomplete message will display with information describing the problem encountered and if any corrective course of action is needed (refer to Test Results later in this chapter for screen examples).
1-6
Masimo Pronto-7 Pulse CO-Oximeter
2
System Description Introduction The Pronto-7 is a Spot Check Pulse CO-Oximeter which provides functional arterial oxygen saturation (SpO2) and non-invasive total hemoglobin (SpHb) measurements. The instrument is designed for accuracy and ease of operation. All pulse CO-Oximetry measurement information, as well as instrument status data, is displayed on the front panel's touchscreen. A Masimo rainbow 4D DC reusable sensor attaches to the top of the Pronto-7. The Pronto-7 is powered by a rechargeable lithium polymer battery. Front Panel and Touchscreen Rainbow 4D DC Connector Port
Spot Checks Tests remaining
LCD Touchscreen
Battery Status 20
12:23 P.M.
14.2
99 71
5 .2
Current Time SpHb g/dL
SpO2 %
PR
Parameters and Measurements
BPM
PI %
Action Buttons 20
12:23 P.M.
14.2
99 71
SpHb g/dL
SpO2 %
PR BPM
Power On/Off
5 .2 Front Panel and Touchscreen Details PI %
Power On/Off Press (power) to turn the instrument on or off. The factory default power save mode automatically powers off the Pronto-7 when button presses and patient monitoring are absent for the time noted on-screen (refer to Section 4, Menu Options Table for options). LCD Touchscreen The touchscreen is interactive. Touch to move through screens, select options, enter information and view instrument specific messages. Spot Check Tests Remaining Displays the number of spot check tests remaining. Press the number to see details and how to order more spot check tests. Rainbow 4D DC Connector Port Connect a rainbow 4D DC reusable sensor to enable spot checks and instrument capability.
Masimo Pronto-7 Pulse CO-Oximeter
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2
System Description Battery Status Displays the battery power remaining. Press the battery icon to see details about the current battery. Use only the included power cable to recharge. Current Time Displays the current time. Press the time to see detailed information. Parameters and Measurements Display Default parameters and meaurements are displayed. Action Buttons Refer to Chapter 3, Commonly Used Buttons for details about the action buttons.
Back Panel
Certification Label Serial Number
Back Panel Details Certification Label The instrument’s certification marks are displayed. Serial Number The Pronto-7 serial number can be used to uniquely identify the instrument and will be needed if Masimo Service is called.
R-16531A
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Masimo Pronto-7 Pulse CO-Oximeter
System Description
2
Bottom Panel Micro SD Card Slot
Mini USB Port
Earphone Jack
Power Port
Bottom Panel Details Earphone Jack To listen to the parameter or measurement results of a successful spot check, plug a standard earphone into the 3.5mm earphone jack. Micro SD Card Slot A micro SD flash memory card is optional. To use, insert the card into the micro SD card slot until you feel a click. This ensures the card is securely connected. The micro SD card can be used to upload new software or additional spot check test credits. Mini USB Port A mini USB to USB cable is included with the instrument. To connect the instrument to a computer, plug the mini USB cable into the port on the instrument and plug the USB cable to the USB port on a computer. Use the mini USB to USB cable to download data to the instrument or upload information to the computer. To protect the instrument, connect only to a medical grade computer to ensure grounding is sufficient. Use only the included mini USB to USB cable. ■■ Do not connect the mini USB to USB cable during a test. ■■ The USB port does not provide power to the sensor. ■■ To prevent possible data loss or interruption, plug the instrument into an AC power supply while uploading or downloading files. ■■ The sensor cannot be charged through the USB port. ■■ Do not disconnect the USB cable from the instrument or the computer while a file transfer is in place. ■■ Eject the instrument as you would any other external drive, per the recommended requirements of your computer manufacturer.
Power Port To charge the instrument, plug the included medical grade +5V/3A power cable into the power port of the instrument and plug the other end into an 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 Pronto-7 Pulse CO-Oximeter
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System Description
2
Symbols The following symbols may be found on the Pronto-7 or packaging and are defined below: Symbol
Description Caution, consult accompanying documents Type BF applied part complying with IEC 60601-1 WEEE Compliant Mark of Conformity to European Medical Device Directive 93/42/EEC
Rx Only
Federal law restricts this device to sale by or on the order of a physician (USA audiences only)
+70 C
-40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg
NON STERILE 5%-95% RH
+70 C
LATEX -40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg
95%
%
NON STERILE 5%-95% RH
Year of manufacture Storage humidity range: 5% to 95% Storage temperature range: +70˚C to -40˚C Storage altitude range: 500 mbar to 1060 mbar Keep dry
5%
LATEX
Title: Graphics, Sensor/Cable symbols, 03/06 GR-14231 DRO-13914
Fragile/breakable, handle with care
95%
%
t, 6/04
5%
EC
REP
EU authorized representative
Title: symbol, art, keep dry
Title: Graphics, Sensor/Cable symbols, 03/06 PCX-1044 GR-14231 Revision: A DRO-13914
DRO-4150
Manufacturer Title: symbol, art, fragile PCX-1045 Revision: A DRO-4150
ETL 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
IPX1
Protection against vertically falling water drops No parameter alarms
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Masimo Pronto-7 Pulse CO-Oximeter
3
Setup Introduction
Before the Pronto-7 can be used, it needs to be inspected, properly setup and the battery should be fully charged. Unpacking and Inspection Remove the instrument from the shipping carton and examine for signs of shipping damage. Check all materials against the packing list. Save the invoice, bill of lading and all packing materials. These may be required if it is necessary to process a claim with the carrier. If anything is missing or damaged, contact the Technical Service Department. The contact address and phone numbers are listed in Section 9, Service and Repair. Included in the package: 1 Masimo Pronto-7 Pulse CO-Oximeter (instrument) 1 AC power cable 1 mini USB to USB cable 1 LCD cleaning cloth 1 Pronto-7 Operator's Manual 1 Rainbow 4D DC Sensor Directions for Use (DFU) with finger gauge Rainbow 4D DC reusable sensor(s) may be included with the instrument.
Commonly Used Buttons Button
Description Turn the instrument on or off. Start a test. Go to the Main menu screen. Submit inputs and exit the menu screen. Press and release to move back one screen. Press and hold to return to "Ready" screen.
623A
Exit a screen. Scroll down a list or page.
GR-16809A
Scroll up a list or page.
GR-16623A
GR-16623A
Displays an interactive dialogue for user options: printing, e-mailing, or deleting test results. Add patient specific information such as name or ID number (#).
Masimo Pronto-7 Pulse CO-Oximeter GR-16623A
3-1