Pronto-7® Spot Check Pulse CO-Oximeter® - CLIA …4495file...These operating instructions intend...

Pronto-7® Spot Check Pulse CO-Oximeter®

Operator's Manual

www.masimo.com 1 Masimo

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.


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.


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

Pronto-7 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


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.


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.

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.



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.



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:

• 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.



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.



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.



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.


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.

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.



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.



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).



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

2. 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.



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).

1Lippi G, et al. Preanalytical variability the dark side of the moon in laboratory testing. Clin Chem Lab Med 2006;44(4):358-365. 2Bonini PA, et al. Errors in laboratory medicine. Clin Chem 2002;48:691-698. 3Simundic A and Lippi G. Preanalytical phase – a continuous challenge for laboratory professional. Biochem 2012;22(2):145-149. 4Badrick T, et al. Uncertainty of Measurement: What it is and What it Should be. Commentary Clin Biochem Rev. November, 2005; 155 – 158.


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.

Pronto-7 Section 2 - System Description



5 Connector Port Provides connectivity for rainbow 4D DC sensors.

CAUTION: Use only rainbow 4D™ DC Reusable Sensors to connect to Pronto-7 Connector Port.

6 Connectivity Indicates Wi-Fi and Bluetooth status.

7 Battery Status Indicates the estimated percentage of battery power remaining.

8 Main Menu Icon Provides access to additional icons and user configurable options.

9 Action Icons Provides user selectable icons for navigation.

10 Power On/Off Turns the device On or Off.

11 Test Icon Allows for commencement of spot check test.

12 LCD Touchscreen Provides an interface for user interactions.



Back Panel

Back Panel Details


1 Certification Label Documents the device's certification marks.

2 Serial Number Lists unique serial number associated with the device.



Bottom Panel

Bottom Panel Details


1 Earphone Jack

3.5mm earphone jack.

CAUTION: Do not connect externally powered devices to earphone jack port.

2 Micro SD Card Slot

Micro SD flash memory card slot.

3 Mini USB Port

Input port for mini USB cable to computer connection.

CAUTION: Use only medical grade computer to connect with via mini USB cable.

4 Power Port Power supply connector for the Pronto-7 specific power supply.


Note: Pronto-7 can be used while the power supply is plugged into an outlet.



Symbols

Symbol Description

Follow Instructions for Use

See Instructions for Use

Separate collection for electronic waste

Mark of conformity to European Medical Device Directive 93/42/EEC

Federal law restricts this device to sale by or on the order of a licensed physician

Authorized Representative in the European Community

Storage/Transport Humidity range: 5% to 95%

Storage/Transport temperature range: +70° C to -40° C

Storage/Transport altitude range: 500 mbar to 1060 mbar

Keep dry

Fragile/breakable, handle with care

Date of Manufacture

Manufacturer

Non sterile



Symbol Description

Type BF Applied Part

IPX1 Protection against vertically falling water drops

No parameter alarms

Serial Number

ETL Certification

Non-ionizing electromagnetic radiation

Federal Communications Commission (FCC) licensing

Wireless features can be used in member states with the restriction of indoor use in France

IC Model Industry Canada Registered Model


Section 3 - Setup

Introduction

Before the Pronto-7 can be used, it needs to be inspected and properly setup, and the battery should be fully charged.

Unpacking and Inspection

Remove the device 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 8 - Service and Repair.

Included in the package:

• Pronto-7 handheld unit

• Screen cleaning cloth

• Soft carrying case

• Quick Reference Sheet- 5 Steps to a Successful and Accurate Spot Check Measurement

• AC power supply

• USB cable

• Pronto-7 Operator's Manual

To unpack and inspect the system follow the steps listed below:

1. Remove Pronto-7 and the components from the shipping carton. 2. Remove all plastic coverings off of the LCD Touchscreen. 3. Examine them for signs of shipping damage. 4. Check all materials against the packing list. 5. Save all packing materials, invoice and bill of lading. These may be required to

process a claim with the carrier.

Sensor Compatibility:

The Pronto-7 uses the rainbow 4D™ DC Reusable Sensors. The sensors come in three available sizes:

• Small: Use with finger sizes between 8mm – 12mm diameter.

• Medium: Use with finger sizes between 12mm – 16mm diameter.

• Large: Use with finger sizes between 16mm – 20mm diameter.

Pronto-7 Section 3 - Setup


Commonly Used Buttons

Button Description

Turns the device on or off.

Starts a test.

Provides access to additional icons and user configurable settings.

Submit an input and exit the menu screen.

Press and release to move back one screen. Press and hold to return to Test Ready screen.

Exit a pop-up window.

Scroll down a list or page.

Scroll up a list or page.

Displays an interactive dialogue for user options: printing, e-mailing, or deleting test results.

Add patient specific information such as ID number (#).

View Page 1.

View Page 2.

Stops test.

Pronto-7 Section 3 - Setup


Preparation for Use

Introduction

To operate the Pronto-7 effectively, the operator must:

• Know how the Pronto-7 derives its readings (refer to Section 1 - Overview).

• Be familiar with its controls and operation.

• Understand its status and messages (refer to Section 5 - Messages and Section 6 - Troubleshooting).

Initial Setup

Follow the steps below for the setting up the Pronto-7:

1. Insert the rainbow 4D™ DC sensor into the connector port. Refer to Sensor Directions for Use (DFU) for more information on the sensor.

2. Power the device on. The touchscreen will illuminate and an audible tone will sound.

3. The time and date need to be set. Enter your region's correct date and time and

press to confirm (refer to Section 4 - Settings Menu for more information). 4. Fully charge the device using the included AC power supply.

Note: The battery may take up to 6 hours to fully charge initially. It will operate for approximately 2 hours when fully charged. The battery should be recharged as needed. Refer to Section 4 - Battery for more information.

Spot Check Test System

To administer a noninvasive test using the Pronto-7, use a Masimo rainbow 4D DC reusable sensor with Spot Check tests.

To see if the rainbow 4D DC reusable sensor contains Spot Check tests, connect it to a

Pronto-7. A numeric value will appear in the top left corner of the screen, next to the icon, with the number of available Spot Check tests it contains.

If there is one (1) or more Spot Check test, the device's main screen will display the title Ready on the screen.

If no Spot Check tests are available, the device's main screen will show zero (0) Spot Check tests in the upper left corner in red and the main screen message will show No Spot Check Tests.


Section 4 - Operation The information in this chapter assumes that Pronto-7 is set up and ready for use. Refer to Section 3- Setup for more information on initial setup of Pronto-7.

Caution: Do not operate the Pronto-7 without completely reading and understanding these instructions.

Pronto-7 Operation

The following sections describe how testing is performed using the Pronto-7 including available parameters, icons, features and accessing user configurable settings.

Connecting and Testing

1. Connect a compatible sensor to the device's patient sensor connector port. Select the appropriate sensor, based on the finger and sensor size. For information on sensor compatibility and appropriate sensor size, refer to Sensor Directions for Use (DFU).

2. Press to power on the device. There will be an audible tone* and the following screen will display:

*If the Sound Effects have been turned to Off, all sounds, including the initial startup tone, will be silenced.

Pronto-7 Section 4 - Operation


3. If a sensor is not attached or not connected completely, this screen displays:

Attach a sensor and continue with step 4.

4. When a sensor is attached, the following Test Ready screen displays and testing can begin:



Patient Testing

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.

CAUTION: Always use the Pronto-7 precisely in accordance with the patient testing instructions 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.

Note: For more information on sensor selection, sensor site selection and sensor placement refer to Sensor Directions for Use (DFU).

Follow the instructions listed below for testing:

1. Ensure the patient has been in the sitting or supine position for 2-3 minutes. Note: Instruct the patient not to move during testing. If this occurs, stop and re-test.

2. With the sensor properly applied, ensure the patient’s hand and arm are securely resting on a flat surface to limit movement of the patient during the testing. Refer to Sensor Directions for Use (DFU) for more information.

3. Tap the Test icon on the Test Ready screen to start the test. 4. When the test is running, there will be an indicator of progress as it relates to the

completion of a test.



5. After a successful test there will be an optional audible tone and the results screen will display. The SpHb parameter is always displayed on page-1. The device can be configured to display other parameters on either page-1 or page-2. Refer to Section 4 - Key Features for more information on displayed parameters, features and user configurable options.

6. If the test needs to be stopped, tap the button. 7. If motion is detected during testing, the screen will display a hand icon at the

bottom right side of the screen as seen below. Excessive motion may result in a Test Incomplete screen. For more information, refer to Section 4-Test Results.

CAUTION: SpO2 and SpHb measurement accuracy are not reliable during motion.



8. If low measurement confidence is detected, the screen will display a low SIQ icon as seen below. If the Low SIQ icon is displayed for a long period of time during measurement, it may result in a Test Incomplete screen. For more information, refer to Section 4- Test Results.

CAUTION: SpO2 and SpHb measurement accuracy are not reliable under low SIQ conditions.

9. After the test is completed, remove the sensor from the patient. If discontinuing

use of the device, press to power down the device.



Test Results

Completed Test

After a successful Spot Check test, parameters are displayed on the Test Results screen.

Additional parameters can be displayed by tapping the icon when available. Press the parameter name or value for more information about the measurement.

Detailed information about the patient can be entered by pressing the icon.

Completed test results can be sent to a designated printer, email address or exported as a .csv file to a micro SD card. Refer to Section 4-Key Features for more information.

Press to exit and return to the Test Ready screen.

The Pronto-7 display screen times out after 5 minutes of inactivity. To turn the screen back on, press the Power On button.

Incomplete Test

An incomplete test can occur due to excessive motion, interference to the device or if

was pressed. If an incomplete test occurs, a Test Incomplete Message as seen below is displayed on the screen.

When a test is incomplete, error code text may display at the bottom left corner of the screen. In the event of a Test Incomplete message, the user should attempt two additional readings while controlling for confounders listed in the directions for use. If the Test Incomplete message persists, then the user should contact Technical Support with the error code on the screen for further assistance. Refer to Section 5- Error Codes for more information.



Ensuring a Successful Spot Check

The following general points will aid in ensuring a successful measurement:

• Select the appropriate sensor, based on the finger and sensor size. It is recommended to use the Finger Gauge to aid in the selection of the sensor. Note: Finger Gauge is included with the rainbow 4D DC sensor.

• Place the sensor on a site that has sufficient perfusion (per the sensor's Directions for Use) and provides proper alignment of the sensor's emitter and detector.

• Place the sensor on a site that has unrestricted blood flow.

• Do not secure the sensor with tape.

• Do not test near potential electrical interference (electrosurgical device, for example).

• Read the Sensor Directions for Use (DFU) for proper sensor application.

• Ensure the patient has been in the sitting or supine position for 2-3 minutes. Instruct the patient not to move during testing. If this occurs, stop and re-test.

Low SIQ

The Pronto-7 provides a visual indication of low measurement confidence by displaying a Low SIQ icon at the bottom of the screen during a measurement when the displayed waveforms are based on inadequate signal quality. Additionally, a hand icon may be displayed as a warning when there is motion during the measurement.



In both cases, a Test Incomplete error may occur if low SIQ continues. For more information, refer to Section 4- Test Results

When a Test Incomplete error occurs due to low SIQ conditions, proceed with caution and do the following:

1. Assess the patient. 2. Check the sensor and ensure proper sensor application. The sensor should not be

placed upside down or sideways on the finger and the sensor must be well secured to the site to obtain accurate readings.

3. Determine if an extreme change in the patient’s physiology and blood flow at the measurement site occurred, e.g. an inflated blood pressure cuff, a squeezing motion, sampling of an arterial blood specimen from the hand containing the sensor, severe hypotension, peripheral vasoconstriction in response to hypothermia, medications, or an episode of Raynaud’s syndrome.

4. After performing the above, retest. An arterial blood specimen for laboratory CO-Oximetry analysis to verify the oxygen saturation and automated hematology analyzer to verify the hemoglobin values should be considered.

Navigating the Main Menu

The Main Menu can be accessed by tapping the Main Menu icon on the Test Ready Screen.



The Main Menu has the following options:

Ref Feature Description

1 Test Results Provides the date of patient testing, the patient ID and the test results.

2 Sound Provides volume, sound effect and voice controls.

3 Connections Provides options for setting up printers, email, and Wi-Fi/Bluetooth connections.

4 Device Diagnostics

Provides an Interference Scan to check environment for interference.

5 Display Provides parameter display options and brightness and finger temperature controls.

6 Settings Provides test mode options, patient settings, date, time and language options.

7 Help Provides access to quick reference guides for testing, FAQ, software updates and equipment reports.

To access each of the menus within the Main menu, tap the appropriate icon.



Test Results Menu

The Test Results Menu provides the date of patient testing, the patient ID and the results produced.

The following are the default settings and user configurable options available via the Test Results Menu:

Option Factory Default Configurable Settings

Date Descending Ascending or descending

Patient ID Patient ID Ascending or descending

Results Most recent tests N/A

Test Results are sortable by date and patient ID. Test results can be rearranged by pressing the column header to sort. The data cannot be sorted by Results.

To access the patient and test details:

1. In the Test Results Menu, tap the Patient ID for whom the test results are needed. The test results will be visible in a pop-up window.

2. Tap the Page 2 icon when available for remaining measurements or tap the

icon to return to the Test Results Menu.

From the Test Results Menu, a user can tap the Printer icon to search all tests (displays a keyboard), delete all tests, print or e-mail the test results, and export results to the Micro SD card (if Micro SD card is inserted). From an individual test result screen a user can tap the

icon to print or e-mail the test result (if those options are setup), export the test to the Micro SD card, edit patient information, delete a single test and e-mail results. Refer to Section 4-Key Features for more information on printing, emailing and exporting test results.



Sound Menu

The Sound Menu provides volume, sound effect and voice controls.

The following are the default settings and user configurable options available via the Sound Menu:


Volume 10 1 - 10

Sound Effects On On, Off

Voice On On, Off

Connections Menu

The Connections Menu provides options for setting up printers, email, and Wi-Fi/Bluetooth connectivity. With an appropriately setup network, completed test results can be emailed or printed.

Printing can be done over an internet connection or via a Bluetooth printer (Bluetooth barcodes can be included in the printouts).

Note: Connections should be created or modified by an administrator familiar with wireless networking and it is recommended that the device be connected to a secure wireless network.

The following are the default settings and user configurable options available via the Connections Menu:


Wireless Network

Wireless Connection Off On, Off

LAN Configuration DHCP DHCP, Static

Available Networks Available networks list User selectable from list




New Network N/A User selectable (SSID, Security On, Off, encryption key WEP64, WEP-128, WPA-TKIP, WPA2-AES, Network password key)

Outgoing Email

User Name N/A Enter Masimo server name

Password N/A Enter Masimo server password

Reply to Address N/A User editable (About Owner screen)

Attach Image

(test screen shot) No Yes, No

Attach .CSV

(.csv data file) Yes Yes, No

Bluetooth Pairing

Bluetooth (2.0) Off On, Off

Security (if Bluetooth is On) Off On, Off

Printer Configuration

Printer Address N/A User editable

Port Number N/A User editable

Print Style Color Color, B/W (Black and White)

Include Picture Yes Yes, No

Include Barcodes No Yes, No



Device Diagnostic Menu

EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause errors or incorrect measurements on the Pronto-7. The Interference Scan in the Device Diagnostic Menu may be used to check the environment for interference.

The following are the default settings and user configurable options available via the Device Diagnostic Menu:

Option Factory Default Configurable Setting

Interference Scan N/A Check Environment for Interference

Display Menu

The Display Menu allows the user to change parameter display options and brightness and finger temperature controls.

The following are the default settings and user configurable options available via the Display Menu:


Brightness 10 1 - 10

SpHb Units of Measure g/dL g/dL, g/L, mmol/L

Display Parameters SpHb, SpO2, PR, PI SpHb, SpO2, PR, PI

Finger Temp. Off °C, °F, Off

Note: The Pronto-7 can display SpHb in g/dL, g/L and mmol/L. Check the Units of Measure before and/or after performing spot check test to avoid misinterpreting the result.

Note: The Pronto-7 can display the temperature of the sensor site, in the top right corner of the display screen if the option is turned on. This may be helpful in determining if the skin is warm or cold. The temperature displayed is the temperature of the finger where the sensor is placed. This is not the patient’s core body temperature and should not be used to make clinical decisions.



Settings Menu

The Settings Menu allows the user to select test mode, change patient settings, language, date and time.

The following are the default settings and user configurable options available via the Settings Menu:


Test Mode

Sensitivity Normal Normal, MAX (see Section 4 - Test Modes for more information)

User ID/Patient ID/PIN

User ID Required Off On, Off

Patient ID required Off On, Off

Pin# Protection Off On, Off

Test Off On, Off

Menu Off On, Off

Create/Change Pin# N/A Up to 15 digit numeric PIN, user editable

If the PIN # is forgotten, tap the Forgot Pin icon along the upper right edge of the Enter PIN keypad.

Language

Language English List available, user selectable

Date and Time

Clock Display On On, Off

Time Format 12 hour 12 hour, 24 hour

Time hh/mm/pm User editable

Date Format mm/dd/yy yy/mm/dd, mm/dd/yy, dd/mm/yy




Date N/A User editable

Power Save Mode

Power Save Mode On On, Off

About Pronto-7 /Owner

About Pronto-7 Masimo Contact Information N/A

About Owner Registered to information

Name, street address, cite, state, country, phone number, email, website

Restore Settings

Restore Default Settings N/A No, Yes

Help Menu

The Help Menu provides access to quick reference guides for testing, FAQ, software updates and equipment reports.

The following are the default settings and user configurable options available via the Help Menu:

Option Description

Quick Start Presents short slide show of basic testing operation.

Common Questions Contains list of questions and answers about the device features.

Contact Tech Support Specifies Masimo Tech Support contact information.

Equipment Report

Documents device serial number, software version, total device run time, last service/location, sensor serial #, total sensor run time, Spot Check tests administered and remaining.



Option Description

Software Update Provides access to upgrade or downgrade the software version from one of three locations: micro SD, internal mass storage, or compatible sensor.

Load Tests Allows user to view available Spot Check tests and/or load the tests into a compatible sensor.

Clear Database Supplies access to erase all measurements and patient/user database.

Device Configurations

Allows download of latest configurations of Pronto-7 that is available, displays a list of features enabled based on existing configuration of the device.

Battery

The Pronto-7 is powered by a rechargeable lithium polymer battery. It can also be powered by AC power, when used with the included AC power supply.

Battery Level Indicator

Battery charge level is indicated by the battery icon in the upper right hand corner of the LCD touchscreen. Battery conditions are:

• When the battery is fully charged, the icon will be solid green:

• When the battery is fully charged and plugged into AC power, an electrical plug

symbol displays on the battery icon:

• As the battery discharges, the capacity will be equivalent to the fraction of green

filling the icon:

• When the battery is charging, a charging symbol will display on the battery icon:



Low Battery Indicator

If the battery power level is too low, the device will not allow a test to be taken. There will be a visual display indicating that the AC power supply must be used to continue.

WARNING: Failure to plug in the AC power supply promptly after the Low Battery indicator displays may result in the device shutting down.


Checking Battery Status

Tap the battery icon at any time to see the current battery status.



Key Features

The following section details some of the key features of Pronto-7.

Viewing Select Parameters

Pronto-7 provides the following parameters:

• Total Hemoglobin (SpHb)

• Functional Arterial Oxygen Saturation (SpO2)

• Pulse Rate (PR)

• Perfusion Index (PI)

Upon successful completion of a Spot Check Test, the default parameters shown on Page 1 of the Test Results screen are SpHb, SpO2, PR, and PI. To display information about each parameter, tap on the appropriate parameter icon. A pop-up window appears for the selected parameter.

If the user would like the Test Results screen to display specific parameters, on page 2, perform the following:

1. Access the Main Menu by tapping on the Main Menu icon. 2. In the Main Menu, tap the Display icon to access the Display Menu. 3. Toggle parameters accordingly to display the parameters preferred on page 2.

Parameters listed under Display Parameters in green are those that are displayed on page 1 of the Test Results screen, those in gray will be displayed on page 2

4. Tap the green check mark icon to accept changes.



Test Modes

Pronto-7 is equipped with four test modes:

• Normal Sensitivity Mode

• MAX Sensitivity Mode



Normal Sensitivity Mode

Normal is the default test mode on the Pronto-7. In the Normal Sensitivity Mode, Pronto-7 SpHb accuracy is 1.0 g/dL at 1 standard deviation in a measurement range of 6-18 g/dL. Refer to Section 7 - Pronto-7 SpHb Accuracy Data for more details.

MAX Sensitivity Mode

The MAX Sensitivity Mode allows for a wider range of acceptable test results. In the MAX Sensitivity Mode, Pronto-7 SpHb accuracy is 1.1 g/dL at 1 standard deviation in a measurement range of 4.5-20 g/dL. Refer to Section 7 - Pronto-7 SpHb Accuracy Data for more details.

To configure test modes before testing:

1. Access the Main Menu by tapping on the Main Menu icon. 2. In the Main Menu, tap the Settings icon to access the Settings Menu. 3. In the Settings Menu, tap Test Mode. 4. Toggle the mode to the desired test mode.

5. Tap the green check mark icon to accept changes.

Note: The Pronto-7 will remain in the Normal or MAX test mode until the user manually switches to the other mode. For more information on settings, refer to Section 4- Navigating the Main Menu.



Emailing Spot Check Test Results

The Pronto-7 device must be connected to a Wi-Fi network to email Spot Check Test Results. Refer to Section 4- Navigating the Main Menu for instructions on connecting to the wireless network.

The following steps should be performed to email Spot Check Test Results:

Setting up a Pronto-7.com account

1. On a computer, go to the following website: www.pronto7.com. 2. Click the New User link and enter required information. 3. In the Sponsor Key field, enter the word email. 4. If registration is successful, your user name and password information is saved.

Retain this information for your records.

Configuring Outgoing Email Settings

1. Access the Main Menu by tapping on the Main Menu icon. 2. In the Main Menu, tap the Connections icon to access the Connections Menu. 3. In the Connections Menu, navigate to the Outgoing Email screen. 4. Enter the user name and password for the Pronto7.com account. 5. In the Reply-To Address field, enter an appropriate email address for receiving

responses. 6. In the Attach Image field, choose Yes if the test results screen image needs to be

attached to an outgoing email. 7. In the Attach .CSV field, choose Yes if the test results spreadsheet need to be

attached to an outgoing email.

Emailing Results

Test results can be emailed from the Test Results screen or Test Results icon, which is accessible from the Main Menu. You can email all test results or individual test results.

To email all test results to a single email address:

1. Access the Main Menu by tapping on the Main Menu icon. 2. In the Main Menu, tap the Test Results icon to access the Test Results Menu. 3. In the Test Results Menu, tap the Email All Tests icon. 4. Enter email address to which the test results will be sent. 5. Tap the Accept icon.

To email individual test results :

1. Access the Main Menu by tapping on the Main Menu icon. 2. In the Main Menu, tap the Test Results icon to access the Test Results Menu. 3. In the Test Results Menu, select the test you wish to email. 4. Tap the Email Single Test icon. 5. Enter email address to which the test results will be sent. 6. Tap the Accept icon.



Printing Spot Check Test Results

Make sure that Pronto-7 device is connected to Bluetooth and/or Wi-Fi network, and printer configuration setting is done.

1. Access the Main Menu by tapping on the Main Menu icon. 2. In the Main Menu, tap the Test Results icon to access the Test Results Menu. 3. In the Test Results Menu, select the single test you wish to print.

4. Tap the icon and tap Print Single Test. 5. Tap Send To Wi-Fi Printer to print to a printer on the Wi-Fi network. 6. Tap Send To Bluetooth Printer to print to a printer connected via Bluetooth.

Exporting Spot Check Test Results to Micro SD Card

Make sure Micro SD card is inserted into the Micro SD card slot of Pronto-7 device.

1. Access the Main Menu by tapping on the Main Menu icon. 2. In the Main Menu, tap the Test Results icon to access the Test Results Menu.

3. Tap the icon and tap "Export All Test Results to Micro SD".


Section 5 - Messages

Messages

The Pronto-7 will indicate other data or system errors. Messages are:

Message Description Solution

Ready Ready for spot check test Initiate spot check test by pressing the green "Test" button

Connect Sensor No sensor is connected Connect a Masimo Rainbow 4D DC sensor to the device

Test Incomplete

Excessive Motion

Poor Signal Quality

Follow on-screen recommendations

Refer to Section 4-Test Results for more information

Low Battery Warning

Battery level too low at start of measurement

Plug in AC power supply

Test Stopped Occurs when the "Stop" button is pressed during a test

Initiate new spot check test by pressing the green "Test" button

Error Codes

Error codes are displayed at the bottom left corner of the Pronto-7 “Test Incomplete” screen and may consist of numbers and other characters. Tap on the error code text to see additional information to help with troubleshooting. In most cases of a Test Incomplete message, the user should repeat the measurement on another finger following the points outlined in Section 4- Ensuring a Successful Spot Check. If the Test Incomplete message persists, then the user should contact Technical Support with the error code on the screen for further assistance.


Section 6 - Troubleshooting

Troubleshooting

The following chart describes what to do if the Pronto-7 system does not operate properly or fails.

Problem Possible Cause(s)

Recommendation(s)

Incomplete Test

Sensor placement

Ensure sensor is placed on a well perfused site. Make sure the patient's finger is all the way in the sensor and touching the finger stop. Route sensor cable along the back of the patient's hand to ensure that the sensor is on in the correct orientation (see the sensor's Directions for Use (DFU)).

Excessive motion

Minimize or eliminate patient movement at the sensor site.

Signal quality Make sure measurement site is well perfused, free of debris and there is no nail polish on the patient's nail. Check the testing environment for interference using the interference scanner in the Settings menu (refer to Section 4-Navigating the Main Menu). If interference is high, shield the sensor from excessive light, modulated light sources (such as computer displays) or strobe lights.

Reflective and/or metallic nail polish

Acrylic nails

Remove all nail polish.

Remove acrylic nails.

Refer to Section 4- Ensuring a Successful Spot Check for additional information.

Device does not power on

Low battery Plug in included AC power supply, then power on the device.

Rainbow 4D DC sensor does not connect to device

Sensor orientation is incorrect

The sensor can only connect one way. Make sure the sensor connector is oriented correctly, according to the sensor's Directions for Use (DFU) and on-screen directions and diagrams.

A computer connected with the included USB cable does not

Connection issue

1. Make sure the device is powered on and plugged into AC power.

2. Check the available drives on your computer. If the Pronto-7 still does not appear, search

Pronto-7 Section 6 - Troubleshooting


Problem Possible Cause(s)

Recommendation(s)

recognize the Pronto-7

your computer's User Manual for proper external drive mapping and troubleshooting.

Touchscreen buttons do not respond when pressed

System failure

Turn off the device and then power it on. If the problem reoccurs or persists return for service (refer to Section 8- Service and Repair).


Section 7 - Specifications

Specifications

Performance

Measurement Range

SpO2 (Arterial Oxygen Saturation) 0 - 100%

PR (Pulse Rate) 30 - 250 bpm

SpHb (Total Hemoglobin) 2 - 25 g/dL

PI (Perfusion Index) 0.02% - 20%

Accuracy

SpO2, ARMS accuracy over 70%- 100% 1 2%

PR, ARMS accuracy over 30 - 250 bpm 2 3 bpm

SpHb, ARMS accuracy over 6 - 18 g/dL 3 1.0 g/dL at 1 SD, Normal Sensitivity Mode

SpHb, ARMS accuracy over 4.5 - 20 g/dL 3 1.1 g/dL at 1 SD, MAX Sensitivity Mode

Resolution

SpO2 1%

PR 1 bpm

SpHb 0.1 g/dL

Product

Type of Use Spot Checking

Pronto-7 Section 7 - Specifications


Test storage Capacity 8000 results

Wireless Connectivity 802.11 b/g, Bluetooth

Reporting Modes Display, Print, Email, Audible

Report Formats Single Test, Multiple Tests, Device Summary

Reporting Devices Optional Bluetooth thermal printer, USB 802.11 wireless (PCL5, 5e 6), or Bluetooth printing to validated printers

Electrical

Battery Rechargeable lithium polymer

Capacity Approximately 2 hours after full charge

Number of spot check tests on fully charged battery

Approximately 140 tests

Battery charging time Approximately 5 hours when powered off

Approximately 6 hours when powered on

Isolation Medical Grade AC/DC Adapter

AC Power 100-240V, 50-60 Hz, 0.6A

Environmental

System Operating Temperature 41°F to 104°F (5°C to 40°C)

Storage/Transport Temperature -40°F to 158°F (-40°C to 70°C)

Operating Humidity 5% to 95%, non-condensing

Operating Air Pressure 500 mbar to 1060 mbar

Physical Characteristics

Dimensions 5.1” x 2.8” x 1” (13cm x 7.2cm x 2.5 cm)

Weight 10.5 oz (296.4 g)

Display/Indicators



Data display: SpO2 %,PR bpm, SpHb g/dL, PI %, battery level indicator, pulse plethysmograph waveform

Type 3.7" Resistive Touchscreen

Visual Indicators Low Battery, System Failure

Compliance

EMC Compliance EN60601-1-2, Class B

Safety Standards Compliance UL 60601-1

CSA/CAN C22.2 No. 601.1

IEC 60601-1, 2nd Edition

IEC 60601-1, 3rd Edition

ISO 9919

ISO 80601-2-61

Equipment Classification per IEC 60601-1

Type of Protection (Battery Power)

Internally powered

Type of Protection (AC Power) Class II

Degree of Protection against Electrical Shock

Type BF-Applied Part

Protection against harm from water

IPX1 (Protection against vertically falling water drops)

Mode of Operation Continuous

Environment Not suitable for use in the presence of flammable anesthetics



1The SpO2 accuracy has been validated in human blood studies on healthy adult male and female subjects with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation, which encompasses 68% of the population. 2Masimo sensors have been validated for pulse rate accuracy for the range of 30-250 bpm in bench top testing against a Fluke Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population. 3The SpHb accuracy has been validated with (arterial/ venous) blood from healthy adult male and female subjects and on patients with light to dark skin pigmentation against a laboratory hematology analyzer. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.

Guidance and Manufacturer's Declaration- Electromagnetic Emissions

Guidance and Manufacturer's Declarations - Electromagnetic Emissions

The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.

Emission Test Compliance Electromagnetic Environment - Guidance

RF Emissions

CISPR 11 Group 1

ME Equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions

CISPR 11 Class B

Suitable for use in all establishments, including domestic environments.



Guidance and Manufacturer's Declaration- Electromagnetic Immunity

Guidance and Manufacturer's Declaration - Electromagnetic Immunity


Immunity Test IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

+6 kV contact

+8 kV air

+6 kV contact

+8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Power frequency (50 / 60 Hz) magnetic field.

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of typical location in a typical hospital environment.

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the ME Equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters



Guidance and Manufacturer's Declaration - Electromagnetic Immunity


Immunity Test IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

(m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ME Equipment is used exceeds the applicable RF compliance level above, the ME Equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.



Recommended Separation Distances

Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment

The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ME Equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ME Equipment as recommended below, according to the maximum output power of the communication equipment.

Rated maximum output power of transmitter (W)

Separation Distance According to Frequency of Transmitter (m)

150 K Hz to 80 MHz

d = 1.17*Sqrt (P)

80 MHz to 800 MHz

d = 1.17*Sqrt (P)

800 MHz to 2.5GHz

d = 2.33*Sqrt (P)

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.7 3.7 7.37

100 11.7 11.7 23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.



Pronto-7 SpHb Accuracy Data

The data in this section describes the accuracy of SpHb measurements by Pronto-7.

Pronto-7 SpHb Accuracy Data - Normal Sensitivity Mode

The data in this section describes the accuracy of SpHb measurements by Pronto-7 in the Normal Sensitivity Mode.

Pronto-7 Performance Summary

Number of Subjects

Number of Data Points Range Correlation Bias ARMS

1,445 11,335 6-18 g/dL

0.89 0.02 g/dL

0.99 g/dL

Subject Demographics

Note: Subject Demographics are grouped by gender, skin tone, study sites and disease/diagnosis.

Clinical Site/ Diagnosis # Points Male Female Light Medium Dark

Hemodilution Procedure/Healthy Adults 2295 24 25 34 12 3

Nephrology: Chronic Kidney Disease Site 1 782 63 76 23 111 5

Nephrology: Chronic Kidney Disease Site 2 549 33 50 42 40 1

Hematology/Oncology: Various Carcinomas 361 8 40 41 7 0

Community Health Fair: Varied Pathology Site 1 89 18 26 38 6 0

Primary Care: Varied Adult Pathology (HTN, DM, etc.) Site 1 433 36 61 97 0 0




OB/GYN: Parturients and Gen Gyn 466 1 67 61 7 0

ED: Critically Anemic Patients 301 18 28 33 13 0




Pediatric: Gen Peds 76 6 14 2 13 5

Community Health Fair: Varied Pathology Site 2 74 18 23 0 41 0

Desaturation Procedure: Healthy Adults 1360 10 8 18 0 0

Total 11443 571 874 1103 320 22

Percentage 100% 39.5% 60.5% 76.3% 22.1% 1.5%

Reference tHb Distribution

The reference tHb distribution in the samples are as seen below:



Pronto-7 SpHb Arms Accuracy

SpHb Performance by tHb Range

Note: 11,443 samples were between 4.5-20 g/dL. Of the 11,443 samples, 11,335 were in Masimo's accepted test range of 6-18 g/dL. The calculation of accuracy was performed on the 11,335 samples in the range of 6-18 g/dL.


tHb Range N Bias (g/dL)

Standard Deviation (g/dL)

Difference Between SpHb and tHb

<1.0 g/L <1.5 g/dL <2.0 g/dL

6-7.9 g/dL 112 0.13 1.18 71% 86% 96%

8 to 9.9 g/dL 653 0.31 0.88 78% 91% 99%

10 to 11.9 g/dL 2,758 0.52 0.94 67% 86% 96%

12 to 13.9 g/dL 3,214 0.14 0.88 83% 94% 99%

14 to 15.9 g/dL 3,242 -0.26 0.89 92% 98% 100%

16-18 g/dL 1,356 -0.74 0.95 97% 99% 100%

6-11.9 g/dL 3,523 0.47 0.94 69% 87% 96%

12-18 g/dL 7,812 -0.18 0.95 89% 97% 99%

Total 11,335 0.02 1.0 84% 94% 99%



SpHb Performance by Site

Note: All the data points in the 6-18 g/dL range (11,335) were analyzed from all the subjects from fourteen different sites. Site specific calculation of accuracy was performed on the 11,335 samples in the range of 6-18 g/dL.

Clinical Site/Site Diagnosis tHb Span (g/dL) Correlation Bias

(g/dL) ARMS Accuracy (g/dL)

Hemodilution Procedure/Healthy Adults

8.3 0.85 0.2 0.9

Nephrology: Chronic Kidney Disease Site 1

9.3 0.85 0.2 1.0


8.7 0.87 -0.3 1.1

Hematology/Oncology: Various Carcinomas

6.8 0.75 0.6 1.2

Community Health Fair: Varied Pathology Site 1

7.0 0.78 -0.1 1.1

Primary Care: Varied Adult Pathology (HTN, DM, etc.) Site 1

7.2 0.81 -0.1 1.0

OB/GYN: Parturients and Gen Gyn 4.9 0.66 0.8 1.2

ED: Critically Anemic Patients 6.2 0.79 0.2 1.1


6.3 0.78 -0.5 1.1


9.1 0.85 -0.2 1.0


9.2 0.85 -0.3 1.0

Pediatric: Gen Peds 2.9 0.56 -0.1 0.8


5.0 0.78 0.1 0.9

Desaturation Procedure: Healthy Adults 6.7 0.91 0.4 0.9



Predicted measurements of Pronto-7 with respect to Invasive tHb Measurements on Whole Blood

(X axis – invasive tHb measurement (g/dL); Y axis- predicted SpHb value (g/dL))



Statistical Results per Subject Demographics

Note: Thirty-four subjects (206 data points) were excluded from the data analysis because of missing demographic information (gender or skin color).

Pronto-7 on Finger: Analysis of Calibration Subject Data by skin pigmentation and gender

tHb Span (g/dL) Correlation Standard Deviation (g/dL)

Light 15.4 0.90 1.00

Medium 14.2 0.91 0.99

Dark 6.0 0.76 1.02

Male 14.4 0.89 0.97

Female 15.4 0.86 1.00

Pronto-7 SpHb Accuracy Data - MAX Sensitivity Mode

The data in this section describes the accuracy of SpHb measurements by Pronto-7 in the MAX Sensitivity Mode.

Pronto-7 Performance Summary

Number of Subjects

Number of Data Points Range Correlation Bias ARMS

1,473 12,662 4.5-20 g/dL

0.88 0.01 g/dL

1.1 g/dL



Subject Demographics

Note: Subject Demographics are grouped by gender, skin tone, study sites and disease/diagnosis.



2400 24 25 34 12 3


957 64 76 23 111 6


690 36 54 45 44 1


413 8 40 41 7 0


99 20 29 42 7 0


470 37 61 98 0 0

OB/GYN: Parturients and Gen Gyn 493 1 69 63 7 0

ED: Critically Anemic Patients 353 18 30 35 13 0


658 40 56 82 14 0


2226 148 199 314 25 8


2324 151 203 322 32 0

Pediatric: Gen Peds 90 7 13 3 13 4


91 21 25 0 46 0

Desaturation Procedure: Healthy Adults

1358 10 8 18 0 0




Total 12622 585 888 1120 331 22

Percentage 100% 39.71% 60.29% 76.04% 22.47% 1.49%

Reference tHb Distribution

The reference tHb distribution in the samples are as seen below:



Pronto-7 SpHb Arms Accuracy


Note: The calculation of accuracy was performed on the 12,622 samples in the range of 4.5-20 g/dL.


tHb Range N Bias (g/dL)

Standard Deviation (g/dL)

Difference Between SpHb and tHb

<1.0 g/L <1.5 g/dL <2.0 g/dL

<8 g/dL 162 0.08 1.54 70% 80% 87%

8 to 9.9 g/dL 742 0.50 1.02 71% 84% 92%

10 to 11.9 g/dL 3,021 0.58 1.02 65% 83% 93%

12 to 13.9 g/dL 3,543 0.15 0.97 82% 92% 97%

14 to 15.9 g/dL 3,476 -0.29 0.99 91% 97% 99%

≥16 g/dL 1,678 -0.87 1.07 96% 99% 100%

<12 g/dL 3,925 0.54 1.06 66% 83% 93%

≥12 g/dL 8,697 -0.22 1.06 88% 95% 98%

Total 12,622 0.01 1.0 81% 91% 96%

SpHb Performance by Site

Note: All the data points (12,622) were analyzed for all the subjects from fourteen different sites. Site specific calculation of accuracy was performed on 12,622 samples in the range of 4.5-20 g/dL.




8.3 0.83 0.2 1.0






9.3 0.79 0.4 1.2


11.6 0.83 -0.3 1.3


6.8 0.71 0.7 1.3


7.0 0.75 -0.1 1.1


7.2 0.75 -0.2 1.1

OB/GYN: Parturients and Gen Gyn 4.9 0.59 0.8 1.4

ED: Critically Anemic Patients 7.7 0.81 0.3 1.4


8.3 0.80 -0.8 1.4


9.1 0.81 -0.2 1.1


9.5 0.83 -0.3 1.1

Pediatric: Gen Peds 2.9 0.45 -0.2 0.8


5.0 0.70 0.1 1.1

Desaturation Procedure: Healthy Adults 6.7 0.90 0.4 0.9



Predicted measurements of Pronto-7 with respect to Invasive tHb Measurements on Whole Blood

(X axis – invasive tHb measurement (g/dL); Y axis- predicted SpHb value (g/dL))



Statistical Results per Subject Demographics

Note: Thirty-four subjects (214 data points) were excluded from the data analysis because of missing demographic information (gender or skin color).

Pronto-7 on Finger: Analysis of Calibration Subject Data by skin pigmentation and gender

tHb Span (g/dL) Correlation Standard Deviation (g/dL)

Light 15.4 0.88 1.11

Medium 15.1 0.88 1.12

Dark 6.0 0.57 1.29

Male 15.2 0.86 1.12

Female 15.4 0.84 1.10


Section 8 - Service and Repair This chapter covers how to properly clean and obtain service for the Pronto-7.

Introduction

The Pronto-7 is a reusable device. The device is supplied and used non-sterile.

Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only.

Cleaning

The outer surface of the Pronto-7 can be cleaned with a soft cloth dampened with a mild detergent and warm water solution. Do not allow liquids to enter the interior of the device. The outer surface of the device can also be wiped down using the following solvents: Cidex Plus (3.4% Glutaraldehyde), 0.25% Ammonium Chloride, 10% Bleach, 70% Isopropyl Alcohol. Use the included LCD cleaning cloth to remove fingerprints from the touchscreen.

CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any AC power source.

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: Use the cleaning solution sparingly. Excessive solution can flow into the Pronto-7 and cause damage to internal components.

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.

Note: Excessive cleaning solution can flow into the device and cause damage to internal components.

Note: Refer to Sensor Directions for Use (DFU) for cleaning instructions of the sensor.

Pronto-7 Section 8 - Service and Repair


Calibration Verification

Pronto-7 does not require any internal adjustment or calibration during clinical use. The calibration coefficients are embedded in the software and validated during manufacturing testing in compliance with Masimo’s ISO-certified quality system procedures. Once the systems have been placed into clinical use, both monitors automatically perform a system verification (self-check) every time the monitors are powered up and at the beginning of every measurement cycle. No other calibration or quality control verification is required.

Safety tests and internal adjustments should be done by qualified personnel only. If any component of the system is not operating within specification, the monitor will not allow a test to be performed and a visual indicator will display with an error code message. In this case, contact your Masimo representative and return the device for service.

Device Software Upgrade

The device software can be upgraded in two ways:

1. Using a Micro SD Card. 2. Using an Internal Storage Device via USB cable.

Using a Micro SD Card to Upgrade Device

1. Insert the Micro SD card with software upgrade file named PRONTO7.BIN into the Micro SD card slot of Pronto-7 device

2. Tap the Main Menu icon on the Test Ready Screen and select the Help Menu icon.

3. In the Help Menu, tap Software Update. 4. If the button next to Micro SD label is enabled, tap it to start the upgrade process.

After several minutes, the device will restart by itself with new software successfully upgraded.

5. If the button next to Micro SD label is disabled and is labeled as Current your device software is up-to-date and no upgrade is needed.



Using an Internal Storage Device to Upgrade Device

1. Connect the Masimo supplied USB cable to a computer. The Pronto-7 should appear as a mass storage device (such as a USB drive on a computer).

2. When the Pronto-7 is visible as a drive, drag the PRONTO7.BIN file provided my Masimo into the Pronto-7 drive.

3. Once the file has completed downloading to the Pronto-7 drive, follow the computer's standard procedure to eject an external mass storage device.

4. After the file has downloaded to the device successfully and the Pronto-7 has been correctly ejected as a mass storage device, the USB cable can be disconnected from the device and the computer.

5. Tap the Main Menu icon on the Test Ready Screen and select the Help Menu icon.

6. In the Help Menu, tap Software Update. 7. If the button next to Internal Mass Storage label is enabled, tap it to start software

upgrade. After several minutes, the device will restart by itself with new software successfully upgraded.

8. If the button next to Internal Mass Storage label is disabled and is labeled Current, your device software is up-to-date and no upgrade is needed.

CAUTION: To protect the device, connect only to a medical grade computer to ensure grounding is sufficient. Use only the included mini USB to USB cable.

Service and Repair

Repair Policy

Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the device repaired prior to use.

CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the Pronto-7 for servicing.

To return the Pronto-7 for service, please follow the Return Procedure.



Return Policy

Remove all saved patient identifying data by deleting all tests (refer to Section 4-Navigating the Main Menu). Please clean contaminated/dirty equipment (refer to Section 8 - Cleaning) before returning and make sure it is fully dry before packing the equipment. Call Masimo Technical Services to request return authorization (RMA), at the phone number below. Package the equipment securely – in the original shipping container if possible – and enclose or include the following information and items:

• A letter describing in detail any difficulties experienced with the Pronto-7. Please include the RMA number in the letter.

• Warranty information – a copy of the invoice or other applicable documentation must be included.

• Purchase order number to cover repair if the device is not under warranty, or for tracking purposes if it is.

• Ship-to and bill-to information.

• Person (name, telephone/telex/fax number, and country) to contact for any questions about the repairs.

• A certificate stating the Pronto-7 has been decontaminated for bloodborne pathogens.

Return the Pronto-7 to the following shipping address:

USA, Canada & Asia Pacific (except Japan): Japan: Europe: All other locations:

Masimo Corporation

40 Parker

Irvine, California 92618

Tel: 949-297-7498, or 800-326-4890 (option 2)

Fax: 949-297-7499

Masimo Japan Corporation

Kojimachi Office

World Time Bldg. 4F

10-7, Ichiban-cho, Chiyoda-ku,

Tokyo 102-0082 Japan

Tel: 03 3237 3057, Fax: 03 3238 1110

Masimo International Sàrl

Puits-Godet 10

2000 Neuchatel

Switzerland

Tel: +41 32 720 1111

Fax.: +41 32 724 1448

Contact your local Masimo Representative



Sales & End-User License Arrangement

This document is a legal agreement between you ("Purchaser") and Masimo Corporation ("Masimo") for the purchase of this product ("Product") and a license in the included or embedded software ("Software"). Except as otherwise expressly agreed in a separate contract for the acquisition of this product,the following terms are the entire agreement between the parties regarding your purchase of this product. If you do not agree to the terms of this agreement, promptly return the entire product, including all accessories, in their original packages, with your sales receipt to Masimo for a full refund.

Limited Warranty

Masimo warrants to the original end-user purchaser the Masimo-branded hardware product (“Product”) and any software media contained in the original packaging against defects in material and workmanship when used in accordance with Masimo’s user manuals, technical specifications, and other Masimo published guidelines for a period of 12 months and any batteries for six (6) months from the original date the Product was obtained by the end-user purchaser.

Masimo’s sole obligation under this warranty is the repair or replacement, at its option, of any defective Product or software media that is covered under the warranty.

To request a replacement under warranty, Purchaser must contact Masimo and obtain a returned goods authorization number so that Masimo can track the Product. If Masimo determines that a Product must be replaced under warranty, it will be replaced and the cost of shipment covered. All other shipping costs must be paid by purchaser.

Exclusions

The warranty does not apply to any non-Masimo branded product or any software, even if packaged with the Product, or any Product that was: (a) not new or in its original packaging when supplied to purchaser; (b) modified without Masimo’s written permission; (c) supplies, devices, or systems external to the Product; (d) disassembled, reassembled, or repaired by anyone other than a person authorized by Masimo; (e) used with other products, like new sensors, reprocessed sensors, or other accessories, not intended by Masimo to be used with the Product; (f) not used or maintained as provided in the operator’s manual or as otherwise provided in its labeling; (g) reprocessed, reconditioned, or recycled; and (h) damaged by accident, abuse, misuse, liquid contact, fire, earthquake or other external cause.

No warranty applies to any Product provided to Purchaser for which Masimo, or its authorized distributor, is not paid; and these Products are provided AS-IS without warranty.



Limitation of Warranty

Except as otherwise required by law or altered by the purchase agreement, the above warranty is the exclusive warranty that applies to the Product and software media, and Masimo does not make any other promises, conditions, or warranties regarding the Product. No other warranty applies, express or implied, including without limitation, any implied warranty of merchantability, fitness for a particular purpose, satisfactory quality, or as to the use of reasonable skill and care. See the licensing terms for the terms and conditions that apply to and Software accompanying the Product.

Additionally, Masimo will not be liable for any incidental, indirect, special, or consequential loss, damage, or expense arising from the use or loss of use of any Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software. The above limitations do not preclude any liability that cannot legally be disclaimed by contract.

End-User License

1. Grant of License: In consideration of payment of the Software license fee, which is part of the price paid for the Product, Masimo grants to Purchaser a nonexclusive, nontransferable (except as set forth below) license (“License”), without right to sublicense, to use the copy of the Software in connection with Purchaser’s use of the Product for its labeled purpose as set forth in these directions for use. Masimo reserves all rights not expressly granted to Purchaser.

2. Ownership of Software: The Software is licensed not sold; all rights and interests in the Software and all copies thereof remain at all times vested in Masimo, and do not pass to Purchaser. Any references in this Agreement to the purchase or sale of the Software shall be deemed the purchase or sale of a Software License as set forth herein.

3. This Software is proprietary and owned by Masimo or its third party suppliers and can be used solely in connection with the monitor described herein.



Restrictions

1. Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden. Purchaser may be held legally responsible for any copyright infringement that is caused or incurred by Purchaser’s failure to abide by the terms of this Agreement. Nothing in this License provides any rights beyond those provided by 17 U.S.C. §117.

2. Use Restrictions: Purchaser may physically transfer the Product from one location to another provided that the Software is not copied. Purchaser may not electronically transfer the Software from the Product to any other device. Purchaser may not disclose, publish, translate, release, distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Software or the written materials.

3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise dispose of the Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo's prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included. Any attempt to assign any rights, duties or obligations arising hereunder other than as set forth in this paragraph shall be void.

4. U.S. Government Rights: If Purchaser is acquiring Software (including the related documentation) on behalf of any part of the United State Government, the following provisions apply: the Software and documentation are deemed to be “commercial software” and “commercial computer software documentation,” respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the Software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this Agreement.

No Implied License

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables that would, alone, or in combination with the device, fall within the scope of one or more of the patents relating thereto. By acceptance or use of this device, you acknowledge your acceptance of these terms.



Sensor Licensed for Monitoring Use Only

Sensors designated for monitoring only are licensed to you under patents owned by Masimo to be used for patient monitoring, in an unmodified form as originally received from Masimo, and no license is granted to have Masimo’s sensors reprocessed or otherwise modified, unless specifically authorized by Masimo. There is no license, implied or otherwise, that would allow use of licensed sensors beyond their intended duration. After use of sensors through their designated duration, there is no further license granted by Masimo to use the sensors and the sensors must be discarded or returned to Masimo for reprocessing.

Additional typefaces for this product can be obtained at www.fonts.com.


Index

A About this Manual • 7

B Back Panel • 25

Back Panel Details • 25 Battery • 48

Battery Level Indicator • 48 Bottom Panel • 26

Bottom Panel Details • 26

C Calibration Verification • 80 Checking Battery Status • 49

Cleaning • 79 Commonly Used Buttons • 30

Connecting and Testing • 33 Connections Menu • 43

Contraindications • 18

D Device Diagnostic Menu • 45 Device Software Upgrade • 80

Display Menu • 45

E Emailing Spot Check Test Results • 53 End-User License • 84

Ensuring a Successful Spot Check • 39 Error Codes • 55

Exclusions • 83 Exporting Spot Check Test Results to

Micro SD Card • 54

F Features and Benefits • 17 Front Panel and Touchscreen • 23

Front Panel and Touchscreen Details • 23 Functional Oxygen Saturation • 19

G General Description for Oxygen

Saturation (SpO2) • 19 General Description for Total

Hemoglobin (SpHb) • 19 Guidance and Manufacturer's

Declaration- Electromagnetic Emissions • 62

Guidance and Manufacturer's Declaration- Electromagnetic Immunity • 63

H Help Menu • 47

I Indications for Use • 18 Initial Setup • 31

Introduction • 23, 29, 31, 79

K Key Features • 50

L Limitation of Warranty • 84

Limited Warranty • 83

Low Battery Indicator • 49 Low SIQ • 39

M Messages • 55

Pronto-7 Index


N Navigating the Main Menu • 40

No Implied License • 85 Noninvasive Total Hemoglobin (SpHb®)

Accuracy Compared to Invasive Laboratory Methods • 3

P Patient Testing • 35

Perfusion Index • 20 Preparation for Use • 31

Principles of Operation • 20 Printing Spot Check Test Results • 54

Product Description • 17 Pronto-7 Operation • 33

Pronto-7 SpHb Accuracy Data • 66 Pronto-7 SpHb Accuracy Data - MAX

Sensitivity Mode • 71

Pronto-7 SpHb Accuracy Data - Normal Sensitivity Mode • 66

Pronto-7 SpHb Arms Accuracy • 68, 74 Pronto-7 vs. Drawn Whole Blood

Measurements • 22 Pulse CO-Oximeter • 19

Pulse Rate (PR) • 19

R Recommended Separation Distances •

65

Reference tHb Distribution • 67, 73 Repair Policy • 81

Restrictions • 85 Return Policy • 82

S Safety Information, Warnings, and

Cautions • 9 Sales & End-User License Arrangement •

83

Section 1 - Overview • 17

Section 2 - System Description • 23 Section 3 - Setup • 29

Section 4 - Operation • 33 Section 5 - Messages • 55

Section 6 - Troubleshooting • 57 Section 7 - Specifications • 59

Section 8 - Service and Repair • 79 Sensor Licensed for Monitoring Use Only

• 86 Service and Repair • 81

Settings Menu • 46 Sound Menu • 43

Specifications • 59 Spot Check Test System • 31

Subject Demographics • 66, 72 Symbols • 27

T Test Modes • 51

Test Results • 38 Test Results Menu • 42

Troubleshooting • 57

U Unpacking and Inspection • 29 Using a Micro SD Card to Upgrade Device

• 80 Using an Internal Storage Device to

Upgrade Device • 81

V Viewing Select Parameters • 50

www.masimo.com

33492/5621T-0915

Date post:	06-May-2018
Category:	Documents
Upload:	hathuy
View:	215 times
Download:	2 times