Pronto-7 Pulse Spot Check CO-Oximeter Operators Manual Sept 2015

For Sale in the USA These operating instructions intend to provide the necessary information for operation of the Pronto-7® Spot Check Pulse CO-Oximeter® (Pronto-7®). There may be information provided in this manual that is not relevant for your system. General knowledge of pulse 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 restricts this device to sale by or on the order of a physician. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. 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:

MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

3148433 Patents: www.masimo.com/patents.htm , Pronto-7, Masimo, Pulse CO-Oximeter, rainbow, SET, Signal Extraction Technology, Signal IQ, SpHb are federally registered trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. Printed in USA © 2015 Masimo Corporation. www.masimo.com

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Noninvasive Total Hemoglobin (SpHb®) Accuracy Compared to Invasive Laboratory Methods For Pronto-7 in Normal Sensitivity Mode in 11,335 comparisons* of total hemoglobin measured by pulse CO-Oximetry (SpHb) and invasive total hemoglobin (tHb) measurements from a laboratory reference device, SpHb accuracy was as follows: •

0.89 correlation

•

0.99 g/dL ARMS accuracy

For Pronto-7 in MAX Sensitivity Mode in 12,622 comparisons* of total hemoglobin measured by pulse CO-Oximetry (SpHb) and invasive total hemoglobin (tHb) measurements from a laboratory reference device, SpHb accuracy was as follows: •

0.88 correlation

•

1.1 g/dL ARMS accuracy

*Refer to Section 7 - Pronto-7 SpHb Accuracy Data for more details.

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Contents Noninvasive Total Hemoglobin (SpHb®) Accuracy Compared to Invasive Laboratory Methods ----------------------------------------------------------------------------------------------------------------- 3 About this Manual -------------------------------------------------------------------------------------------7 Safety Information, Warnings, and Cautions ----------------------------------------------------------- 9 Safety Warnings and Cautions ----------------------------------------------------------------------- 10 Performance Warnings and Cautions --------------------------------------------------------------- 11 Cleaning and Service Warnings and Cautions ---------------------------------------------------- 14 Compliance Warnings and Cautions ---------------------------------------------------------------- 14 Section 1 - Overview --------------------------------------------------------------------------------------- 17 Product Description ------------------------------------------------------------------------------------ 17 Pulse CO-Oximeter ------------------------------------------------------------------------------------- 19 Section 2 - System Description -------------------------------------------------------------------------- 23 Introduction --------------------------------------------------------------------------------------------- 23 Front Panel and Touchscreen ------------------------------------------------------------------------ 23 Back Panel ----------------------------------------------------------------------------------------------- 25 Bottom Panel ------------------------------------------------------------------------------------------- 26 Symbols -------------------------------------------------------------------------------------------------- 27 Section 3 - Setup------------------------------------------------------------------------------------------- 29 Introduction --------------------------------------------------------------------------------------------- 29 Unpacking and Inspection --------------------------------------------------------------------------- 29 Preparation for Use ------------------------------------------------------------------------------------ 31 Section 4 - Operation ------------------------------------------------------------------------------------ 33 Pronto-7 Operation ----------------------------------------------------------------------------------- 33 Navigating the Main Menu -------------------------------------------------------------------------- 40 Battery ---------------------------------------------------------------------------------------------------48 Key Features ------------------------------------------------------------------------------------------- 50 Section 5 - Messages --------------------------------------------------------------------------------------55 Messages ------------------------------------------------------------------------------------------------55 Error Codes ----------------------------------------------------------------------------------------------55 Section 6 - Troubleshooting ----------------------------------------------------------------------------- 57 Troubleshooting ---------------------------------------------------------------------------------------- 57 www.masimo.com

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Contents

Section 7 - Specifications -------------------------------------------------------------------------------- 59 Specifications------------------------------------------------------------------------------------------- 59 Guidance and Manufacturer's Declaration- Electromagnetic Emissions --------------------- 62 Guidance and Manufacturer's Declaration- Electromagnetic Immunity --------------------- 63 Recommended Separation Distances -------------------------------------------------------------- 65 Pronto-7 SpHb Accuracy Data ----------------------------------------------------------------------- 66 Section 8 - Service and Repair -------------------------------------------------------------------------- 79 Introduction -------------------------------------------------------------------------------------------- 79 Cleaning ------------------------------------------------------------------------------------------------- 79 Calibration Verification ------------------------------------------------------------------------------ 80 Device Software Upgrade ---------------------------------------------------------------------------- 80 Service and Repair ------------------------------------------------------------------------------------- 81 Sales & End-User License Arrangement ----------------------------------------------------------- 83 Limited Warranty -------------------------------------------------------------------------------------- 83 End-User License -------------------------------------------------------------------------------------- 84 Restrictions --------------------------------------------------------------------------------------------- 85 No Implied License ------------------------------------------------------------------------------------ 85 Sensor Licensed for Monitoring Use Only --------------------------------------------------------- 86 Index --------------------------------------------------------------------------------------------------------- 87

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About this Manual This manual explains how to set up and use the Pronto-7® Spot Check Pulse CO-Oximeter®. Important safety information relating to general use of the Pronto-7 appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user. 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 this device or damage to other property. 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.

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Safety Information, Warnings, and Cautions CAUTION: Pronto-7 is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. CAUTION: Always use the Pronto-7 precisely in accordance with the directions in this manual, including site selection, sensor placement, and subject behavior during testing. Failure to follow all of the directions in this manual could lead to inaccurate measurements. CAUTION: Prior to using this device, the user should read and understand the Operator’s Manual and Directions for Use. Laboratory diagnostic tests using blood samples should be conducted prior to clinical decision making to completely understand the patient’s condition. Comparisons between SpHb measurements and laboratory diagnostic hemoglobin measurements may be affected by sample type, collection technique, physiology, and other factors.

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Pronto-7

Safety Information, Warnings, and Cautions

Safety Warnings and Cautions WARNING: Do not use Pronto-7 if it appears or is suspected to be damaged. WARNING: Do not adjust, repair, open, disassemble, or modify the Pronto-7. Injury to personnel or equipment damage could occur. WARNING: Do not start or operate the Pronto-7 unless the setup was verified to be correct. WARNING: To ensure safety, only use Masimo authorized devices with Pronto-7. WARNING: All sensors and cables are designed for use with specific devices. Verify the compatibility of the device, cable, and sensor before use; otherwise degraded performance and/or patient injury can result. WARNING: Only use the AC power supply provided by Masimo. Using a different AC power supply could result in degraded performance and/or patient injury, and cause damage to Pronto-7. Check the power cord and plug to ensure that it is intact and undamaged. WARNING: 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. WARNING: Do not replace battery. Replacement of battery by inadequately trained personnel could result in risk of explosion. WARNING: Do not use the Pronto-7 during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Do not remove the back panel of the device. This could cause injury to personnel or device damage. WARNING: Electrical Shock Hazard: To protect against injury, follow the directions below: • • • • •

Avoid placing the device on surfaces with visible liquid spills. Do not soak or immerse the device in liquids. Do not attempt to sterilize the device. Use cleaning solutions only as instructed in this Operator's Manual. Do not attempt to clean the Pronto-7 while monitoring patient.

WARNING: Electrical Shock Hazard: Injury to personnel could occur. Do not plug in or remove the power supply with wet hands. Ensure that your hands are clean and dry before touching the power supply. WARNING: Do not connect the USB cable to the computer while the sensor is applied to the patient. WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. WARNING: Do not place the Pronto-7 or accessories in any position that might cause it to fall on 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-7 where the controls can be changed by the patient.

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Pronto-7

Safety Information, Warnings, and Cautions

CAUTION: Equipment intended to be connected to signal input/signal output ports should comply with applicable electrical safety standards to further minimize the risk of electric shock. Only devices that have been configured to operate with Pronto-7 may function properly when connected. CAUTION: Do not place Pronto-7 where the appliance inlet or the AC power supply cannot be readily disconnected. CAUTION: To protect the device, connect only to a medical grade computer. Use only the included mini USB to USB cable. Note: Disconnect the device from AC mains by removing the AC power supply from the device inlet. Note: Use and store the Pronto-7 in accordance with specifications. See the Specifications section in this manual.

Performance Warnings and Cautions WARNING: Pronto-7 is not an apnea monitor. WARNING: Pronto-7 should not be used as a replacement or substitute for ECG-based arrhythmia analysis. WARNING: Do not use during defibrillation. This may affect the accuracy or availability of the parameters and measurements. WARNING: Do not use during electrocautery. This may affect the accuracy or availability of the parameters and measurements. WARNING: Pronto-7 is intended only as an adjunct device in patient assessment. It should not be used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check Pronto-7 for proper functioning. WARNING: Pronto-7 is intended to be used only for spot checking. Pronto-7 has no audible alarms and should not be used for continuous monitoring. WARNING: Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff. This may cause incorrect measurements. WARNING: Failure to apply sensor properly may cause incorrect measurements. WARNING: Misapplied sensor or sensors that become partially dislodged may cause incorrect measurements. WARNING: With very low perfusion at the monitored site, the reading may read lower than core arterial oxygen saturation. WARNING: Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from monitored site. WARNING: Excessive venous pulsations may cause erroneous low SpO2 readings (e.g. tricuspid valve regurgitation, Trendelenburg position). WARNING: Interfering Substances: Dyes or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. www.masimo.com

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Pronto-7

Safety Information, Warnings, and Cautions

WARNING: SpO2 and SpHb are empirically calibrated in healthy adult subjects with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). WARNING: If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. WARNING: Inaccurate SpO2 readings may be caused by: • •

• • • • • •

Improper sensor application. Elevated levels of COHb and MetHb: High levels of COHb or MetHb may occur with a seemingly normal SpO2. When elevated levels of COHb or 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.

WARNING: Inaccurate SpHb readings may be caused by: • • • • • • • • • • • • • • • •

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Improper sensor application. Intravascular dyes, such as indocyanine green or methylene blue. Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc. Elevated PaO2 levels. Elevated levels of bilirubin. Low arterial perfusion. Motion artifact. Low arterial oxygen saturation levels. Elevated carboxyhemoglobin levels. Elevated methemoglobin levels. 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.

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Pronto-7

Safety Information, Warnings, and Cautions

WARNING: Variation in hemoglobin measurements may be profound and may be affected by sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data. As with most hemoglobin tests, confirmation by conventional laboratory methods may be necessary prior to clinical decision making. WARNING: EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause errors or incorrect measurements on the Pronto-7. CAUTION: Do not place the Pronto-7 on electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Pronto-7 promptly after a Low Battery display indicator may result in the device shutting down. CAUTION: If using 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 device might read zero for the duration of the active irradiation period. CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy. CAUTION: High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor. CAUTION: To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate measurements. CAUTION: If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Pronto-7. CAUTION: The wireless quality of services may be influenced by the presence of other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID, MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices, consideration should be taken to maximize separation distances and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength. Note: Pronto-7 is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication. Note: Before using Pronto-7, make sure the battery is sufficiently charged. Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the battery. Note: A functional tester cannot be used to assess the accuracy of Pronto-7.

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Pronto-7

Safety Information, Warnings, and Cautions

Cleaning and Service Warnings and Cautions WARNING: Do not attempt to reprocess, recondition or recycle the Pronto-7 as these processes may damage the electrical components, potentially leading to patient harm. WARNING: Electrical Shock Hazard: The Pronto-7 battery should be installed and/or removed from Pronto-7 only by qualified personnel. WARNING: Electric Shock Hazard: The battery should not be removed from the Pronto-7. WARNING: Do not incinerate the Pronto-7 battery. CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the Pronto-7 for servicing. CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any AC power source. CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-applied circuits and the system are within acceptable limits as specified by the applicable safety standards. The summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting external equipment to the system. When an event such as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur. CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the display. CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Pronto-7. These substances affect the device’s materials and device failure can result. CAUTION: Do not submerge the Pronto-7 in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device. CAUTION: To prevent damage, do not soak or immerse Pronto-7 in any liquid solution. Note: Excessive cleaning solution can flow into the device and cause damage to internal components.

Compliance Warnings and Cautions WARNING: Changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. CAUTION: Connecting Pronto-7 to the wireless network could affect the network. CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories. Note: Use Pronto-7 in accordance with the Environmental Specifications section in the Operator's Manual. www.masimo.com

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Pronto-7

Safety Information, Warnings, and Cautions

Note: 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. Note: 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.

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: When using the Pronto-7’s wireless features outside the United States, consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless devices. Note: This equipment has been tested and found to comply with the Class B limits for medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments. Note: This Class B digital apparatus complies with Canadian ICES-003.

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Section 1 - Overview Product Description The Pronto-7 Spot Check Pulse CO-Oximeter is developed to noninvasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb) and perfusion index (PI). The device has a single on/off button and an interactive touchscreen for administering spot check tests along with user selectable options.

Features and Benefits Noninvasive Measurement and Display of Functional Arterial Oxygen Saturation (SpO2) and Pulse Rate (PR) The device uses multiple wavelengths of light and proprietary algorithms to obtain functional arterial oxygen saturation (SpO2) and pulse rate (PR) readings. Total Hemoglobin (SpHb) The device measures total hemoglobin (SpHb) using pulse oximetry principles with additional wavelengths of light and proprietary algorithms to obtain the measurements. Perfusion Index (PI) The device measures Perfusion Index (PI). This indicates arterial pulse signal strength.

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Pronto-7

Section 1 - Overview

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 and other details.

•

Interference Scanner mode for detecting interference in testing environments.

•

Print, export 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 SET 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, and ambulatory surgery centers).

Contraindications The Pronto-7 is contraindicated for use as an apnea monitor. The Pronto-7 is also contraindicated for use as a continuous monitor.

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Pronto-7

Section 1 - Overview

Pulse CO-Oximeter The following chapter contains general descriptions about parameters, measurements, and the technology used by Masimo products.

General Description for Oxygen Saturation (SpO2) 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 device (1). The sensor collects signal data from the patient and sends it to the device. The device displays the calculated data as a percent value for functional arterial oxygen saturation (SpO2).

Functional Oxygen Saturation The Pronto-7 is calibrated to measure and display functional arterial 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.

General Description for Total Hemoglobin (SpHb) Pulse CO-Oximetry devices offer a noninvasive method of measuring the levels of total hemoglobin in blood (SpHb). It relies on pulse oximetry principles to make SpHb measurements. The device displays the data as grams/deciliter (g/dL) for SpHb (with different units of measure available in the display menu).

Pulse Rate (PR) Pulse rate (PR), measured in beats per minute (bpm) is based on the optical detection of peripheral flow pulse.

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Pronto-7

Section 1 - Overview

Perfusion Index The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue. PI thus represents a noninvasive measure of peripheral perfusion that can be noninvasively obtained from a pulse oximeter.

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).

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Pronto-7

Section 1 - Overview

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. 1. 2.

Light Emitting Diodes (LEDs) (7 + wavelengths) Detector

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 arterial oxygen saturation (%SpO2), total hemoglobin concentration (SpHb [g/dL]) and pulse rate (bpm). The SpHb measurement relies on a multi-wavelength calibration equation to estimate the total hemoglobin concentration in the blood. The maximum skin surface temperature is measured to be less than 106º F (41º C) in a minimum 95º F (35º C) ambient. This is verified by Masimo sensor skin temperature test procedures.

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Pronto-7

Section 1 - Overview

Pronto-7 vs. Drawn Whole Blood Measurements It is important to recognize all measuring devices and processes have an inherent level of variability. SpO2 and SpHb measurements obtained from the device (noninvasive) when compared to drawn whole blood measurements (invasive) by blood gas and/or automated laboratory hematology analyzer may differ. There are a variety of factors that may significantly impact the difference. For noninvasive SpO2 and SpHb measurements, the factors are described as part of the Safety Information, Warnings and Cautions. For invasive blood test, error and/or variability may occur at three separate phases1-4: •

Pre-analytical - patient preparation, sample collection, transportation, storage, and processing before analysis.

•

Analytical - sample analysis.

•

Post-analytical - report generation, delivery and interpretation.

Each phase is susceptible to some level of error and/or variability that can impact the accuracy and precision of the measurement. Some of the most common sources of variability in invasive measurements are: •

Sample Integrity - sample type (arterial, venous, or capillary), collection technique, timing between measurements, tourniquet release time.

•

Physiological - body position, homeostasis, hydration, blood source, and site of blood draw.

•

Biological – gender, age, ethnicity, and rhythms (circadian).

1 Lippi G, et al. Preanalytical variability the dark side of the moon in laboratory testing. Clin Chem Lab Med 2006;44(4):358-365. 2

Bonini PA, et al. Errors in laboratory medicine. Clin Chem 2002;48:691-698.

3

Simundic A and Lippi G. Preanalytical phase – a continuous challenge for laboratory professional. Biochem 2012;22(2):145-149. 4

Badrick T, et al. Uncertainty of Measurement: What it is and What it Should be. Commentary Clin Biochem Rev. November, 2005; 155 – 158.

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Section 2 - System Description Introduction The Pronto-7 is designed to noninvasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb) and perfusion index (PI). The Pronto-7 is powered by a rechargeable lithium polymer battery and uses a Masimo rainbow 4DTM DC Reusable Sensor which connects to the top of the device.

Front Panel and Touchscreen

Front Panel and Touchscreen Details Ref. Feature

Description

1

Spot Check Tests

The number next to the icon indicates the number of spot check tests remaining on the attached sensor.

2

Test Ready Screen

Indicates Pronto-7 is ready for testing.

3

Sensor Size

Specifies the size of the attached sensor (small, medium or large).

4

Time

Displays device's time.

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