Pronto Pulse CO-Oximeter Operators Manual June 2016

These operating instructions provide the necessary information for proper operation of all models of the Pronto. 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 Pronto are prerequisites for its proper use. Do not operate Pronto 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 (USA) law restricts this device to sale by or on the order of a physician. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked 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 applicable regulatory authorities, or in any manner inconsistent with the directions for use or labeling. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. 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 Medical electrical equipment with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1 80fk Patents: www.masimo.com/patents.htm © 2016 Masimo Corporation , Discrete Saturation Transform, DST, FST, Masimo, Pronto, Pulse CO-Oximeter, rainbow, rainbow ReSposable, SET, Signal Extraction Technology, Signal I.Q., and SpHb are federally registered trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners.

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Contents About This Manual------------------------------------------------------------------------------------------ 5 Product Description, Features, and Indications for Use -----------------------------------------------7 Product Description and Features ---------------------------------------------------------------------7 Indications for Use---------------------------------------------------------------------------------------7 Contraindications ----------------------------------------------------------------------------------------7 Safety Information, Warnings, and Cautions ----------------------------------------------------------- 9 Safety Warnings and Cautions ------------------------------------------------------------------------ 9 Performance Warnings and Cautions --------------------------------------------------------------- 10 Cleaning and Service Warnings and Cautions ---------------------------------------------------- 13 Compliance Warnings and Cautions ---------------------------------------------------------------- 14 Chapter 1: Technology Overview ------------------------------------------------------------------------ 15 Masimo Signal Extraction Technology (Masimo SET®) ----------------------------------------- 15 rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 17 Chapter 2: System Description -------------------------------------------------------------------------- 21 Front Panel ---------------------------------------------------------------------------------------------- 21 Rear Panel ----------------------------------------------------------------------------------------------- 23 Chapter 3: Setup ------------------------------------------------------------------------------------------- 25 Unpacking and Inspection --------------------------------------------------------------------------- 25 Power Requirements ----------------------------------------------------------------------------------- 25 Initial Setup --------------------------------------------------------------------------------------------- 25 Chapter 4: Operation -------------------------------------------------------------------------------------- 27 Basic Operation ---------------------------------------------------------------------------------------- 27 Default Settings ---------------------------------------------------------------------------------------- 29 Audible Alerts ------------------------------------------------------------------------------------------ 30 Battery Level Indicator ------------------------------------------------------------------------------- 30 Navigating the Menu ---------------------------------------------------------------------------------- 31 Trend Setup and Use --------------------------------------------------------------------------------- 33 Chapter 5: Messages ------------------------------------------------------------------------------------- 35 Messages ----------------------------------------------------------------------------------------------- 35 Chapter 6: Troubleshooting ----------------------------------------------------------------------------- 39 Troubleshooting --------------------------------------------------------------------------------------- 39 www.masimo.com

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Contents

Low Perfusion ------------------------------------------------------------------------------------------- 40 Low Signal I.Q. (Low SIQ) ---------------------------------------------------------------------------- 40 Low Battery Audible Alert ---------------------------------------------------------------------------- 41 Chapter 7: Specifications --------------------------------------------------------------------------------- 43 Performance Specifications -------------------------------------------------------------------------- 43 Display Ranges ----------------------------------------------------------------------------------------- 44 Resolution ----------------------------------------------------------------------------------------------- 44 Electrical------------------------------------------------------------------------------------------------- 44 Environmental------------------------------------------------------------------------------------------ 45 Physical Characteristics ------------------------------------------------------------------------------ 45 Trend Memory ------------------------------------------------------------------------------------------ 45 Alerts ----------------------------------------------------------------------------------------------------- 45 Display Indicators-------------------------------------------------------------------------------------- 46 Compliance --------------------------------------------------------------------------------------------- 46 Citations ------------------------------------------------------------------------------------------------- 48 Symbols-------------------------------------------------------------------------------------------------- 49 Guidance and Manufacturer's Declaration - Electromagnetic Emissions -------------------- 51 Guidance and Manufacturer's Declaration - Electromagnetic Immunity -------------------- 52 Recommended Separation Distances -------------------------------------------------------------- 55 Chapter 8: Service and Maintenance ------------------------------------------------------------------ 57 Cleaning ------------------------------------------------------------------------------------------------- 57 Battery Replacement ---------------------------------------------------------------------------------- 57 Performance Verification ----------------------------------------------------------------------------- 58 Service and Repair ------------------------------------------------------------------------------------- 58 Limited Warranty ------------------------------------------------------------------------------------- 60 Exclusions ---------------------------------------------------------------------------------------------- 60 Limitation of Warranty ------------------------------------------------------------------------------- 60 Sales & End-User License Agreement -------------------------------------------------------------- 61 Restrictions --------------------------------------------------------------------------------------------- 61 Index --------------------------------------------------------------------------------------------------------- 63

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About This Manual This manual explains how to set up and use Pronto® Pulse CO-Oximeter®. Important safety information relating to general use of Pronto 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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Product Description, Features, and Indications for Use Product Description and Features Pronto® Pulse CO-Oximeter® is a noninvasive device intended to monitor functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), perfusion index (PI), and total hemoglobin (SpHb®). The following key features are available for Pronto: •

Masimo SET® and rainbow® SET technology performance.

•

SpO2 and pulse rate monitoring in motion and low perfusion environments.

•

Noninvasive spot-checking of total arterial hemoglobin concentration (SpHb).

•

Download capabilities to transfer data from the device to a computer.

Indications for Use The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric individuals during both no motion and motion conditions, and for individuals who are well or poorly perfused in clinical and nonclinical settings (e.g., hospitals, hospital-type facilities, mobile environments, homes, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

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

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Safety Information, Warnings, and Cautions Caution: Pronto 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.

Safety Warnings and Cautions WARNING: Do not use the Pronto if it appears or is suspected to be damaged. WARNING: Do not start or operate Pronto unless the setup was verified to be correct. WARNING: Do not use Pronto during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Explosion hazard: Do not use the Pronto in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. WARNING: Do not place the Pronto or accessories in any position that might cause it to fall on the patient. WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. WARNING: 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 Pronto while monitoring patient.

WARNING: To protect from electric shock, always remove the sensor and completely disconnect Pronto before bathing 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 where the controls can be changed by the patient.

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Pronto

Safety Information, Warnings, and Cautions

Performance Warnings and Cautions WARNING: Pronto should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. 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. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition. WARNING: If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check Pronto for proper functioning. WARNING: Do not use Pronto for continuous monitoring. WARNING: Pronto is not an apnea monitor. WARNING: Pronto should not be used for arrhythmia analysis. WARNING: Do not use Pronto during defibrillation. WARNING: Do not use Pronto during electrocautery. WARNING: Do not place containers with liquids on or near Pronto. Liquids spilled on Pronto may cause it to perform inaccurately or fail. WARNING: Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. WARNING: SpO2 and SpHb are empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). WARNING: Inaccurate SpO2 readings may be caused by: •

Improper sensor application and placement

•

Elevated levels of COHb or 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.

•

Elevated levels of bilirubin

•

Elevated levels of dyshemoglobin

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Vasospastic disease, such as Raynaud’s, and peripheral vascular disease

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Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc.

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Hypocapnic or hypercapnic conditions

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Severe anemia

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Very low arterial perfusion

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Extreme motion artifact

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Abnormal venous pulsation or venous constriction

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Severe vasoconstriction or hypothermia

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Arterial catheters and intra-aortic balloon

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Pronto

Safety Information, Warnings, and Cautions

•

Intravascular dyes, such as indocyanine green or methylene blue

•

Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.

•

Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers. etc.

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Skin color disorders

Warning: Inaccurate SpHb readings may be caused by: •

Improper sensor application and placement

•

Low arterial oxygen saturation levels

•

Elevated carboxyhemoglobin levels

•

Elevated methemoglobin levels

•

Elevated levels of bilirubin

•

Elevated levels of dyshemoglobin

•

Elevated PaO2 levels

•

Vasospastic disease, such as Raynaud’s, and peripheral vascular disease

•

Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc.

•

Hypocapnic or hypercapnic conditions

•

Peripheral vascular disease

•

Liver disease

•

Severe anemia

•

Low arterial perfusion

•

Motion artifact

•

Abnormal venous pulsation or venous constriction

•

Severe vasoconstriction or hypothermia

•

Arterial catheters and intra-aortic balloon

•

Intravascular dyes, such as indocyanine green or methylene blue

•

Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.

•

Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers. etc.

•

Skin color disorders

•

Elevated altitude

•

EMI radiation interference

CAUTION: Do not place the Pronto on electrical equipment that may affect the device, preventing it from working properly. www.masimo.com

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Pronto

Safety Information, Warnings, and Cautions

CAUTION: The device must be configured to match your local power line frequency to allow for the cancelation of noise introduced by fluorescent lights and other sources. CAUTION: If the Low SIQ Indicator illuminates frequently, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. CAUTION: If using pulse oximetry 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: If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. Note: A functional tester cannot be used to assess the accuracy of the Pronto. Note: It is recommended that Pronto battery is fully charged prior to use. 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: Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling. Note: Additional information specific to the Masimo sensors compatible with Pronto, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU). Note: High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the Pronto to obtain vital sign readings.

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Pronto

Safety Information, Warnings, and Cautions

Cleaning and Service Warnings and Cautions WARNING: Do not adjust, repair, open, disassemble, or modify Pronto. Injury to personnel or equipment damage could occur. Return Pronto for servicing. WARNING: Electrical Shock Hazard: The battery should be installed and/or removed from the Pronto by qualified personnel only. WARNING: Do not incinerate battery. WARNING: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Pronto. These substances affect the device’s materials and device failure can result. WARNING: 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: An operator may only perform maintenance procedures specifically described in the manual. Refer servicing to qualified service personnel trained in the repair of this equipment. CAUTION: Do not submerge Pronto in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage Pronto. CAUTION: Electric shock hazard: Do not open the Pronto cover except to replace the battery or batteries. CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn off the device and remove batteries. 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. Note: Excessive cleaning solution can flow into the monitor and cause damage to internal components.

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Pronto

Safety Information, Warnings, and Cautions

Compliance Warnings and Cautions WARNING: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. CAUTION: Disposal of product - Comply with local laws in the disposal of the device and/or its accessories. CAUTION: Dispose of used batteries according to country or regional regulations. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Pronto. Note: Use the Pronto in accordance with Environmental Specifications section in this manual. 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: 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 a typical medical installation. Note: In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and TV reception. The user is cautioned that changes and modifications made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment. 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: This Class B digital apparatus complies with Canadian ICES-003.

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Chapter 1: Technology Overview The following chapter contains general descriptions for the parameters, measurements, and technology used within Masimo products.

Masimo Signal Extraction Technology (Masimo SET®) The signal processing in Masimo Signal Extraction Technology (Masimo SET®) 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 conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET® pulse oximetry utilizes parallel engines and adaptive filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET® signal processing algorithm, Discrete Saturation Transform® (DST®), in parallel with Fast Saturation Transform (FST®), reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.

Masimo SET® Parallel Engines This figure is for conceptual purposes only.

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Pronto

Chapter 1: Technology Overview

Masimo SET® DST This figure is for conceptual purposes only.

General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: 1. 2.

Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry). The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

Functional Oxygen Saturation (SpO2) The Pronto 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. Note: Dyshemoglobins are not capable of transporting oxygen, but are recognized as oxygenated hemoglobins by conventional pulse oximetry.

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

General Description for Perfusion Index (PI) 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 continuously and noninvasively obtained from a pulse oximeter.

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Pronto

Chapter 1: Technology Overview

rainbow Pulse CO-Oximetry Technology rainbow Pulse CO-Oximetry technology is governed by the following principles: 1.

2.

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). The amount of arterial blood in tissue changes with pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

Pronto uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood, and blood plasma. Pronto utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a diode (detector). Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) 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 ≤ 25 mW. The detector receives the light, converts it into an electronic signal, and sends it to Pronto for calculation. 1. 2.

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

Once the Pronto 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 (PR). The SpHb measurement relies on a multi-wavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin and the concentration of total hemoglobin in arterial blood. Maximum skin-sensor interface temperature was tested to be less than 41º C (106º F) in a minimum ambient temperature of 35º C (95º F). The tests were conducted with sensors operating at reasonable worst case power. www.masimo.com

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Pronto

Chapter 1: Technology Overview

Pulse CO-Oximetry vs. Drawn Whole Blood Measurements When SpO2 and SpHb measurements obtained from Pronto (noninvasive) are compared to drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry methods, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO2 and SpHb measurements of Pronto. Any comparisons should be simultaneous, meaning the measurement on the device should be noted at the exact time that blood is drawn. 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. In the case of SpHb, 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, a laboratory blood sample should be analyzed prior to clinical decision making. 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 methemoglobin 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 CO-Oximetry 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 with Low Signal IQ should not be compared to laboratory measurements.

General Description for Total Hemoglobin (SpHb) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make its SpHb measurement. The measurement is taken by a sensor capable of measuring SpHb, usually on the fingertip for adults and pediatric patients. The sensor connects directly to the Pulse CO-Oximeter or with a patient cable. The sensor collects signal data from the patient and sends it to the device. The device displays the calculated data as measurement of total hemoglobin concentration.

Successful Monitoring for SpHb A stable SpHb reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration, and perfusion. See Safety Information, Warnings, and Cautions on page 9.

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Pronto

Chapter 1: Technology Overview

SpO2 and SpHb Measurements During Patient Motion Pronto displays measurements of SpO2 and may display SpHb during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable during excessive motion. In this case, the Low SIQ indicator illuminates to alert the clinician that the device does not have confidence in the value displayed due to poor signal strength caused by excessive motion or other signal interference. For more information, see Low Signal I.Q. (Low SIQ) on page 40.

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Chapter 2: System Description Pronto is a Spot Check Pulse CO-Oximeter that includes noninvasive total hemoglobin (SpHb) measurement. All hemoglobin pulse oximetry measurement information, as well as device status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel, and the sensor cable connection is located at the top edge of the device. Pronto is powered by four (4) AA alkaline batteries to provide up to eight (8) hours of continuous use when used with new, fresh batteries. Continuous use is defined as consecutive spot check tests with each consecutive spot check test initiated immediately upon the conclusion of the previous spot check test. A spot check sensor or patient cable attaches to the connector on the top of Pronto.

Front Panel

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Pronto

Ref. Feature

Chapter 2: System Description

Description

1

Parameter/ Measurement Numeric Display

Displays parameter/measurement numeric values once a spot check test is complete.

2

Pulse Indicator

Flashes with patient's pulse reading (PR) during spot check test period.

3

Incrementally illuminates upward after a SpHb spot check has been initiated. Spot Check indicates progress towards completion of a SpHb spot check. A fully Progress Indicator This illuminated spot check progress indicator indicates a competed spot check.

4

Parameter/ Measurement Label Display

Displays parameter/measurement label once a spot check test is complete.

5

Power Button

Powers the device on or off. Press the button once to power on. Press and hold the button for two (2) seconds to power off.

6

Battery Level Indicator

Battery charge level is indicated by four LED indicators. All four indicators will be lit when the batteries are full, with fewer indicators being lit as the batteries lose their charge. For more information, see Battery Level Indicator on page 30.

7

Patient Cable / Sensor Connector

The Patient Cable/Sensor connector is where a compatible sensor is connected to the device.

8

Low SIQ Indicator

This illuminates to indicate low confidence in the measurement displayed. For more information, see Low Signal I.Q. (Low SIQ) on page 40.

9

Sensor Use Indicator

This illuminates to display the approximate number of uses remaining for the attached sensor. The bottom LED will turn red when the remaining uses for the connected sensor are low. The approximate number of sensor uses remaining is displayed upon power up (if a sensor is attached) and when a sensor is connected.

10

SpHb Button

Press to initiate total hemoglobin (SpHb) spot check information on display or to display a total hemoglobin (SpHb) spot check test. When navigating the device menu, pressing this button will move to the next menu option and will confirm a setting change. For more information, see Navigating the Menu on page 31.

11

Up/Down Arrow Buttons

Use the Up or Down arrow buttons to scroll between parameter or measurement spot check results. When in the device menu, use the Up or Down arrow buttons to scroll through menu setting options. For more information, see Navigating the Menu on page 31.

12

Speaker

Provides audible indication of alert conditions, pulse tone, and feedback for control button presses.

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Pronto

Chapter 2: System Description

Rear Panel

Ref. Feature 1

Serial Number Label

2

Certification Label

3

Battery Cover

4

Battery Cover Release

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