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DRAFT 02 17 14 Pronto-7 Operator's Manual Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter, also referred to as Pronto-7, operating instructions provide the necessary information for proper operation of Pronto-7. There may be information provided in this manual that is not relevant for your system. Do not operate Pronto-7 without completely reading and understanding the instructions in this manual. Notice:
Purchase or possession of this instrument does not carry any express or implied license to use this instrument with replacement parts which would, alone or in combination with this instrument, fall within the scope of one of the relating patents. Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. 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. Masimo, SpHb and Signal I.Q. are registered trademarks of Masimo Corporation.
, Signal Extraction Pulse CO-Oximeter, rainbow, Pronto-7, SET, All other trademarks and registered trademarks are property of their respective owners. Printed in U.S.A. www.masimo.com 1 Masimo 2014 Masimo Corporation. www.masimo.com 2 Masimo Contents About this Manual -------------------------------------------------------------------------- 55 Product Description ----------------------------------------------------------------------- 77 Indications for Use --------------------------------------------------------------------- 77 Contraindications ----------------------------------------------------------------------- 77 Safety Information, Warnings, and Cautions---------------------------------------- 99 Safety Information, Warnings, and Cautions --------------------------------- 1010 Compliance Information, Warnings and Cautions --------------------------- 1213 Sensor Information, Warnings and Cautions --------------------------------- 1414 Chapter 1: Technology Overview --------------------------------------------------- 1515 Signal Extraction Technology (SET) -------------------------------------------- 1515 rainbow Pulse CO-Oximetry Technology -------------------------------------- 1515 Functional Oxygen Saturation ---------------------------------------------------- 1616 Pronto-7 vs. Drawn Whole Blood Measurements --------------------------- 1616 Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods* --------------------------------------------------------------- 1717 Chapter 2: Product Description------------------------------------------------------ 1919 Pronto-7 Description ---------------------------------------------------------------- 1919 Pronto-7 Front Panel and Touchscreen --------------------------------------- 2020 Pronto-7 Back Panel ---------------------------------------------------------------- 2222 Pronto-7 Bottom Panel ------------------------------------------------------------- 2323 Parameter and Measurement Descriptions ----------------------------------- 2323 Chapter 3: Setup ------------------------------------------------------------------------ 2525 Unpacking and Inspection the System ----------------------------------------- 2525 Preparation for Use ----------------------------------------------------------------- 2525 Chapter 4: Operation ------------------------------------------------------------------- 2727 Common Screens ------------------------------------------------------------------- 2828 Commonly Used Icons ------------------------------------------------------------- 2828 Recommended Initial Testing Procedure -------------------------------------- 3030 www.masimo.com 3 Masimo Pronto-7Pronto-7 Contents Patient Testing ----------------------------------------------------------------------- 3332 Completed Test ---------------------------------------------------------------------- 3534 Incomplete Test ---------------------------------------------------------------------- 3634 Key Features ------------------------------------------------------------------------- 3635 Main Menu Options ----------------------------------------------------------------- 5147 Battery ---------------------------------------------------------------------------------- 5854 Chapter 5: Alarms and Messages -------------------------------------------------- 6157 Messages------------------------------------------------------------------------------ 6157 Chapter 6: Troubleshooting ---------------------------------------------------------- 6359 Troubleshooting ---------------------------------------------------------------------- 6359 Chapter 7: Specifications ------------------------------------------------------------- 6561 Specifications ------------------------------------------------------------------------- 6561 Calibration Verification ------------------------------------------------------------- 6864 Symbols -------------------------------------------------------------------------------- 6864 Chapter 8: Service and Repair ------------------------------------------------------ 7167 Service and Repair ------------------------------------------------------------------ 7167 Index --------------------------------------------------------------------------------------- 7973 www.masimo.com 4 Masimo About this Manual This manual explains how to set up and use Pronto-7. Important safety information relating to general use of the product 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 and, death) to the patient or user. The following is an example of a warning:
WARNING: This is an example of a warning statement. A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to Pronto-7 or damage to other property. The following is an example of a caution:
CAUTION: This is an example of caution statement. A note is given when additional general information is applicable. The following is an example of a note:
Note: This is an example of a note. Read the entire safety information section before you operate the instrument. www.masimo.com 5 Masimo Product Description Indications for Use The Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter and Accessories are indicated for noninvasive spot check testing of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate (PR), and total hemoglobin concentration (SpHb). The Masimo rainbow SET Pronto-7 Spot Check 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). The Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter is designed to simultaneously and noninvasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb), perfusion index
(PI), and hematocrit (SpHct). Advanced features available on the Pronto-7 include SpHct access, multi test mode, low signal I.Q., measurement through motion of SpHb and SpO2, wireless download of spot check tests, SpO2 only mode and EMR connectivity for parameter and measurement download. The instrument is voice automated, provides step by step instructions when administering tests and is equipped with an interactive touchscreen for user selectable options. Contraindications The Pronto-7 is contraindicated for use as an apnea monitor. The Pronto-7 is also contraindicated for use as a continuous monitor. www.masimo.com 7 Masimo Safety Information, Warnings, and Cautions The following section lists warnings, cautions, notes, and safety information for Pronto-7. Pronto-7 is to be operated by qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. www.masimo.com 9 Masimo Pronto-7 Safety Information, Warnings, and Cautions Safety Information, Warnings, and Cautions Always use the Pronto-7 precisely in accordance with the directions in this manual, including finger selection, finger alignment in the sensor, and subject behavior during testing. Failure to follow all of the directions in this manual could lead to inaccurate measurements. The Pronto-7 should be considered an early warning device. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patients condition. Variation in hemoglobin measurements may be profound and may be affected by sample type, body positioning, as well as other physiological conditions. As with most hemoglobin tests, Pronto-7 test results should be scrutinized in light of a specific patients condition. Any results exhibiting inconsistency with the patients clinical status should be repeated and/or supplemented with additional test data. Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The Pronto-7 should not be used as a replacement or substitute for ECG based arrhythmia analysis. If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patients condition. SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). Inaccurate SpO2 readings may be caused by:
Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. 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 Motion artifact Low arterial perfusion Inaccurate SpHb readings may be caused by:
Improper sensor application Intravascular dyes such as indocyanine green or methylene blue www.masimo.com 10 Masimo Pronto-7 Safety Information, Warnings, and Cautions Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc. Low arterial perfusion Elevated PaO2 levels Elevated levels of bilirubin 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 Peripheral vascular disease EMI radiation interference Liver disease SpHct is NOT reliable in cases of abnormal blood composition and is not indicative of disease states. Abnormal values of SpHct that are displayed should warrant repeat testing by conventional laboratory methods. High intensity extreme lights (including pulsating strobe lights and direct sunlight) directed on the sensor, may not allow the Pronto-7 to obtain readings. As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Do not place the Pronto-7 or accessories in any position that might cause it to fall on the patient. Do not lift the Pronto-7 by the cable or sensor. Ensure the sensor is physically intact, with no broken or frayed wires or damaged parts. Visually inspect the sensor and discard if cracks or discoloration are found. Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. Do not use the Pronto-7 or sensor during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Pronto-7 may affect the MRI image and the MRI device may affect the accuracy of the Pulse CO-Oximetry parameters and measurements. Do not use the Pronto-7 during electrocautery. Do not use the Pronto-7 or sensor during defibrillation. Do not place the Pronto-7 where the controls can be changed by the patient. www.masimo.com 11 Masimo Pronto-7 Safety Information, Warnings, and Cautions Do not expose the Pronto-7 to excessive moisture such as direct exposure to rain. Excessive moisture can cause the instrument to perform inaccurately or fail. Do not place containers with liquids on or near the Pronto-7. Liquids spilled on the instrument may cause it to perform inaccurately or fail. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Explosion hazard. Do not use the Pronto-7 in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide. EMI radiation interference such as computer displays and / or LCD / plasma TVs can cause errors or incorrect measurements on the Pronto-7. To protect against injury from electric shock, follow the directions below:
Avoid placing the device on surfaces with visible liquid spills. Do not soak or immerse the device in liquids. Use cleaning solutions sparingly. Always remove the sensor from the patient and completely disconnect the patient from the Pronto-7 before bathing the patient. A functional tester cannot be utilized to assess the accuracy of the Pronto-7 or its rainbow 4D DC reusable sensors. Do not place the Pronto-7 on electrical equipment; it may prevent it from working properly. If Pronto-7 is used adjacent to other electrical equipment, the device should be observed to verify normal operation. Compliance Information, Warnings and Cautions Use the Pronto-7 in accordance with the Environmental Specifications in this manual. Do not incinerate device and/or battery. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the www.masimo.com 12 Masimo Pronto-7 Safety Information, Warnings, and Cautions 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. Connect the equipment into an outlet on a circuit different from that to Increase the separation between the equipment and receiver. which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the FDA, or in any manner inconsistent with the instructions for use or labeling. The device and related accessories are not intended for use in combination with other medical devices or in high-risk applications. Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories. This equipment has been tested and found to comply with Class B limits for medical devices according to the EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments. This Class B digital apparatus complies with Canadian ICES-003. Do not open the Pronto-7 instrument. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment. In accordance with international telecommunication requirements, the frequency band of 5,150 MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. Pronto-7 is provided with RF wireless capabilities. When used outside the US, consideration should be taken to account for local/ national regulations or restrictions for RF wireless technologies prior to using the wireless feature. RF Exposure: The Pronto-7 was tested for SAR compliance with a 0mm separation distance. In order to maintain FR exposure compliance, the device should not be used for any other body worn accessories. www.masimo.com 13 Masimo Pronto-7 Safety Information, Warnings, and Cautions Sensor Information, Warnings and Cautions If using the Pronto-7 during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the instrument might read zero for the duration of the active irradiation period. Failure to apply the sensor properly may lead to incorrect measurements. Do not loop the sensor cable into a tight coil or wrap around the device, as this can damage the sensor cable. Additional information specific to Masimo's rainbow 4D DC reusable sensor, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's Directions For Use
(DFU). Do not expose the rainbow 4D DC reusable sensor to moisture, liquids or a humid environment, as this may make the sensor perform inaccurately or fail. Do not use damaged sensors. Do not use a sensor with exposed optical or electrical components. Do not immerse the sensor in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Do not sterilize by irradiation, steam, autoclave or ethylene oxide unless otherwise indicated in the sensor's directions for use. See the cleaning instructions in the sensors' directions for use. Do not attempt to reprocess, recondition or recycle any Masimo sensors or patient cables as these processes may damage the electrical components, potentially leading to patient harm. www.masimo.com 14 Masimo Chapter 1: Technology Overview Signal Extraction Technology (SET) Masimo Signal Extraction Technology's signal processing differs from that of conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the venous blood also moves, causing conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform
(DST), in parallel with Fast Saturation Transform (FST), reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor. rainbow Pulse CO-Oximetry Technology 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). www.masimo.com 15 Masimo Pronto-7 Chapter 1: Technology Overview 2. The amount of arterial blood in tissue changes with a persons pulse
(photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of blood changes as well. The Pronto-7 uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood and blood plasma. The Pronto-7 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to multiple photodiodes (detectors). See the figure below. Light-Emitting Diodes (LEDs)
(7+ Wavelengths) Detectors Signal data is obtained by passing various visible and infrared lights (ranging from 500nm up to 1300nm) through a capillary bed (for example, a fingertip) and measuring changes in light absorption during the blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at 25mW. The detectors receive the light, convert it into an electronic signal and send it to the Pronto-7 for calculation. Once the Pronto-7 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient's functional oxygen saturation (%SpO2), total hemoglobin concentration (SpHb [g/dL]) and pulse rate (BPM). The SpHb measurement relies on a multiwavelength calibration equation to estimate the percentage of total hemoglobin in blood. In an ambient temperature of 95 F (35 C) the maximum skin surface temperature has been measured at less than 106 F (41 C), verified by Masimo sensor skin temperature test procedure. Functional Oxygen Saturation The Pronto-7 is calibrated to measure and display functional oxygen saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. Refer to the Safety information, Warnings and Cautions section in front of this manual for details. Pronto-7 vs. Drawn Whole Blood Measurements When SpO2 and SpHb measurements obtained from the instrument
(noninvasive) are compared to drawn whole blood measurements (invasive) www.masimo.com 16 Masimo Pronto-7 Chapter 1: Technology Overview by blood gas and/or laboratory hematology, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratory hematology measurements may differ from the SpO2 and SpHb measurements of the Pronto-7. In the case of SpO2, different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. High levels of bilirubin may cause erroneous SpO2 and SpHb readings. As blood samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a meaningful comparison can only be achieved if the oxygen saturation, carboxyhemoglobin and mehemoglobin concentration of the patient are stable and not changing over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory hematology measurements of SpO2 and SpHb may vary with the rapid administration of fluids and in procedures such as dialysis. Additionally, drawn whole blood testing can be affected by sample handling methods and time elapsed between blood draw and sample testing. Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods*
The following is data of the sensor compatible with the Pronto-7: Rainbow 4D DC Reusable Sensor. rainbow 4D DC Reusable Sensor For Normal Sensitivity Mode in 10,253 comparisons of SpHb and invasive hemoglobin (tHb) measurements from a laboratory reference device in the range of 8-17 g/dL, SpHb accuracy was as follows:
0.90 correlation 1.05 g/dL ARMS accuracy For Maximum (MAX) Sensitivity Mode in 13,205 comparisons of SpHb and invasive hemoglobin (tHb) measurements from a laboratory reference device, SpHb accuracy was as follows:
0.86 correlation 1.00 g/dL ARMS accuracy www.masimo.com 17 Masimo Chapter 2: Product Description Pronto-7 Description The Pronto-7 is designed to simultaneously and noninvasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin
(SpHb), perfusion index (PI) and hematocrit (SpHct ). The instrument is voice automated, provides step by step instructions when administering tests, and is equipped with an interactive touchscreen for user selectable options. The Test Ready screen, as seen in the following image, indicates a compatible sensor has been properly inserted into the Pronto-7 and the instrument is ready for testing. The Main Menu icon, also available on the Test Ready screen, provides access to additional icons and user configurable options. Parameters and measurements are displayed on the Test Results screen and may include functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb), perfusion index (PI), and hematocrit (SpHct). Measurements are collected through the rainbow 4D DC sensor, connected via the connector port. www.masimo.com 19 Masimo Pronto-7 Chapter 2: Product Description Pronto-7 Front Panel and Touchscreen www.masimo.com 20 Masimo Pronto-7 Chapter 2: Product Description Ref. Feature Description 1 2 3 4 5 6 7 8 9 10 11 12 Power On/Off LCD Touchscreen Test Ready Screen Connector Port Places instrument in Power On and Power Off modes. Provides an interface for user interactions. Indicates Pronto-7 is ready for testing. Provides connectivity for rainbow 4D DC sensors. Time Displays instrument's time. Battery Status Action Icons Test Icon Main Menu Icon Radical Sign Sensor Size Connectivity Indicates the estimated percentage of battery power remaining. Provides user selectable icons for navigation. Allows for commencement of spot check test. Provides access to additional icons and user configurable options. Indicates the number of spot check test credits remaining on the attached sensor. Specifies the size of the attached sensor (small, medium or large). Indicates Wi-Fi and Bluetooth status. www.masimo.com 21 Masimo Pronto-7 Pronto-7 Back Panel Chapter 2: Product Description Ref. Feature Description 1 Certification Label Documents the instruments certification marks. 2 Serial Number Lists unique serial number associated with the instrument. www.masimo.com 22 Masimo Pronto-7 Chapter 2: Product Description Pronto-7 Bottom Panel Ref. Feature Description 1 Earphone Jack 3.5mm earphone jack. 2 Micro SD Card Slot Micro SD flash memory card slot. 3 Mini USB Port Input port for mini USB cable to computer connection. 4 Power Port Power supply connector for the Pronto-7 specific power cable. Parameter and Measurement Descriptions Total Hemoglobin (SpHb) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make its SpHb measurement. The measurement is taken by a sensor capable of measuring SpHb, usually on the fingertip for adult and pediatric patients. The sensor connects directly to the Pulse CO-Oximeter or with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as measurement of total hemoglobin concentration. www.masimo.com 23 Masimo Pronto-7 Chapter 2: Product Description Arterial Oxygen Saturation (SpO2) Pulse oximetry is a noninvasive method of measuring the level of functional arterial oxygen saturation in blood. The instrument displays the calculated data as a percent value for functional arterial oxygen saturation (SpO2). A SpO2 reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site. Pulse Rate (PR) Pulse rate (PR), measured in beats per minute (BPM) is based on the optical detection of peripheral flow pulse. Perfusion Index (PI) The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue. PI thus represents a noninvasive measure of peripheral perfusion that can be continuously and noninvasively obtained from a pulse oximeter. Hematocrit (SpHct) Hematocrit (SpHct) is the fraction of whole blood volume that consists of red blood cells. In normal conditions, there is a linear relationship between hematocrit and the concentration of hemoglobin. An estimated hematocrit as a percentage may be derived by multiplying the hemoglobin concentration in g/ dL times three and dropping the units 1,2. The hematocrit measurement is determined mathematically in the instrument as*:
%SpHct = 3.0422 x SpHb 0.8059 The measurement is taken by a sensor capable of measuring SpHct, usually on the fingertip for adults or pediatric patients. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as measurement of SpHct. The hematocrit estimation is NOT reliable in cases of abnormal blood composition and is not indicative of disease states. Abnormal values of hematocrit that are displayed should warrant repeat testing by conventional laboratory methods.
*Note: This is the relationship found between tHb and SpHb for 3,226 blood samples measured on a Coulter LH 500 Hematology Analyzer. www.masimo.com 24 Masimo Chapter 3: Setup Unpacking and Inspection the System To unpack and inspect the system 1. Remove Pronto-7 and the components from the shipping carton. 2. Examine them for signs of shipping damage. 3. Check all materials against the packing list. 4. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact the Masimo Technical Service Department, see Return Procedure on page 7369. Preparation for Use Before the Pronto-7 can be used, it needs to be properly setup and fully charged. Note: The initial battery charge can take up to 6 hours. 1. Power the instrument on. The touchscreen will illuminate and a series of audible tones will sound. To change the audible tone settings, see Sound Icon on page 5249. 2. The time and date need to be set. Enter your region's correct date and time. 3. Tap the green check mark icon to accept changes. 4. Fully charge the instrument using the included AC power cable. 5. Insert the rainbow 4D DC sensor to the connector port. www.masimo.com 25 Masimo Chapter 4: Operation The information in this chapter assumes that Pronto-7 is set up and ready for use. Do not operate the Pronto-7 without completely reading and understanding these instructions. The following sections describe how the Pronto-7 information is displayed, including available parameters, icons, features and accessing user configurable settings. Pronto-7 may provide the following parameters and features:
Key Parameters:
Total Hemoglobin (SpHb) Arterial Oxygen Saturation (SpO2) Pulse Rate (PR) Perfusion Index (PI) Hematocrit (SpHct) Key Features:
Viewing Select Parameters Viewing SpHct Low Signal I.Q. (Low SIQ) Sensitivity and Test MOdes Emailing Spot Check Test Results Download of Spot Check Tests EMR Connectivity www.masimo.com 27 Masimo Pronto-7 Common Screens Item Description Chapter 4: Operation Connect Sensor screen indicates a compatible sensor should be properly connected to the Pronto-7 in order to begin testing. Test Ready screen indicates the Pronto-7 is ready for testing. Test Results screen provides parameter and measurement test results. Commonly Used Icons Icons Description Turns the instrument on/off. www.masimo.com 28 Masimo Chapter 4: Operation Pronto-7 Icons Description Starts a test. Provides access to additional icons and user configurable settings. Submits inputs and exits the Main Menu. Moves back one screen. Pressing and holding returns to Test Ready screen. Exits pop-up windows. Scrolls down the list or page. Scrolls up the list or page. Displays an interactive dialogue for user options: printing, e-mailing, or deleting test results. www.masimo.com 29 Masimo Pronto-7 Icons Description Chapter 4: Operation Adds patient specific information. Discontinues test. Recommended Initial Testing Procedure SpHb Spot Check Measurement Note: Potentially inaccurate results can occur if the user does not properly follow the testing procedure. As with any diagnostic test, clinicians should always evaluate hemoglobin measurements in the perspective of the clinical context of the patient. Sensor Site Selection 1. Assess the patients arm of the selected site for any restrictions from shoulder to fingertip. 2. Restrictive garments or accessories should be removed as it can impede blood flow to the sensor site. (Example: purse, backpacks, watches, jewelry and blood pressure cuff). Do not use sites with any of the following conditions:
An anatomically abnormal finger (e.g. damaged, clubbed, deviated, etc.) A finger or arm that has experienced previous surgical procedures A finger or arm that is currently receiving an IV infusion 3. Site should be cleaned of debris and dry prior to testing. 4. Select the patients testing finger in the following priority:
Non-dominant ring or middle finger Dominant ring or middle finger www.masimo.com 30 Masimo Pronto-7 Sensor Selection Chapter 4: Operation Pronto-7 is compatible with rainbow 4D DC sensors, which has three sizes:
large, medium and small. Use the Finger Size Guide attached to the sensor to ensure the correct sensor is being used. 1. Measure the patients finger size (diameter) at the cuticle to determine the correct sensor size using the Finger Size Guide. 2. Gently close sides of Finger Size Guide until the edges touch the outside of the finger. The arrow indicates which size of sensor should be used on the patients. If Finger Size Guide falls on the line select the smaller sensor for testing. 3. Sensor Placement 1. Rest patients hand and arm with sensor on a horizontal surface. The hand and arm should be securely resting on a flat surface to limit the movement of the patient. The patients hand should be placed on the table palm side down. 2. Ensure the test finger just touches the finger stopper at the end of the sensor without going over it, and sits in line with the finger. This allows the emitter and detector to be placed on the optimum location for monitoring. 3. Examine the finger while placed in the sensors to ensure the emitter and detector are directly aligned on top of each other. 4. Ensure the cable runs flat over the top of the hand directly in the middle of the finger with no kinks or twists so the cable does not pull on the sensor. www.masimo.com 31 Masimo Pronto-7 Performing a Test Chapter 4: Operation 1. Ensure the patient has been in the sitting or supine position for 2-3 minutes. 2. With the sensor properly applied, ensure the patients hand and arm are securely resting on a flat surface to limit movement of the patient during the reading. 3. Tap the Test icon on the Test Ready screen to commence the test. In instances of test incomplete messages, try the following to increase the probability of a successful test:
Remove Nail Polish/Acrylics as certain types of nail polish and acrylics may affect the reading. Warm Finger to increase perfusion. Use a light shield to cover the sensor from ambient light interference. Do not perform measurements in environments with high ambient light or in front of monitors as incomplete tests may occur. In these environments, a Masimo ambient light shield should be used to limit the effect on the measurement www.masimo.com 32 Masimo Pronto-7 Patient Testing Chapter 4: Operation Note: The patient should be in a seated position for 2-3 minutes prior to, and during testing. Do not allow the patient to talk, laugh, cough or move during testing. If this occurs, stop and re-test. Tap the Test test is running, there will be an indicator of progress as it relates to the completion of a test, as seen in the following image. icon on the instruments Test Ready screen. When the Successful Testing Ongoing www.masimo.com 33 Masimo Pronto-7 Chapter 4: Operation If motion is detected, a hand icon will appear at the bottom right side of the screen. (If the motion is not stopped and Measure Through Low SIQ is not on, the test may be incomplete, in some cases, a measurement can be displayed despite low signal quality conditions). See Low Signal I.Q. (Low SIQ) on page 3836. Patient Motion and Low SIQ Detected Patient Motion Detected Low SIQ Detected After a complete test there will be a series of audible tones and the Test Results screen will display. www.masimo.com 34 Masimo Pronto-7 Completed Test Chapter 4: Operation After a successful spot check test, parameters may be seen on the Test Results screen. Additional parameters may be seen by tapping the when available. Detailed information about the patient can be entered by icon pressing the icon. If the printer or email options are configured, they can be accessed through the print/email icon at the bottom of the screen. See Emailing Spot Check Test Results on page 4442 for further details. Completed test results can be sent to a designated printer, email address or exported as a .csv file, by following the on-screen instructions. The test results will dim and turn gray after 5 minutes of inactivity to indicate to the user that the numbers they are viewing are from the previous test. Tap the green check mark icon to exit the Test Results screen and return to the Test Ready screen. www.masimo.com 35 Masimo Pronto-7 Incomplete Test Chapter 4: Operation An incomplete test can occur due to excessive motion, interference to the instrument or if the red stop icon was pressed. The examples below show incomplete test message screens. When a test is incomplete, error code text may display at the bottom left corner of the screen. See the recommended initial testing procedure SpHb Spot Check Measurement on page 3030 on for proper sensor and site selection. For troubleshooting, see Chapter 6: Troubleshooting on page 6359. Key Features The following section details some of the features available on the Pronto-7. See Main Menu Options on page 5147 for additional features. www.masimo.com 36 Masimo Pronto-7 Chapter 4: Operation Viewing Select Parameters Upon successful completion of a spot check test, the default parameters shown on the firs page of the Test Results screen are SpHb, SpO2, PR, and PI. If the user would like the Test Results screen to display specific parameters, on page 2, perform the following:
1. Tap the Main Menu icon. 2. Tap the Display icon. 3. Toggle parameters accordingly to display the parameters preferred on page 1. Parameters listed under Display Parameters in green are those that may be displayed on the Test Results screen page 1, those in gray will be displayed on page 2. 4. Tap the green check mark icon to accept changes. Information about each parameter is available. Tap directly on the parameter for access. A pop-up window appears for the selected parameter. Viewing SpHct There are two ways to access SpHct. To access prior to conducting a test, perform the following:
1. Tap the Main Menu icon. 2. Tap the Display icon. 3. Toggle to SpHct under Units of Measure. 4. Tap the green check mark icon to accept changes. To access upon completion of a test, perform the following:
1. Tap the SpHb text next to the SpHb numeric result. 2. The text will spin to show the resulting SpHct measurement. Tap on the SpHct text next to the SpHct numeric result to return to SpHb. www.masimo.com 37 Masimo Pronto-7 Low Signal I.Q. (Low SIQ) Chapter 4: Operation The Pronto-7 provides a visual indication of low signal quality by displaying, as seen in the following image, a Low SIQ icon at the bottom of the screen during a measurement when the displayed waveforms are based on inadequate signal quality. Additionally, a hand icon may be displayed as a warning when there is motion during the measurement. In both cases, the test may be canceled if low signal quality continues. In some cases, a measurement can be displayed despite low signal quality conditions. If the Low SIQ icon is displayed, it indicates that the accuracy specifications claimed have not been met. When the test is canceled 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 patients 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 pulse oximetry sensor, severe hypotension, peripheral vasoconstriction in response to hypothermia, medications, or an episode of Raynauds syndrome. 4. After performing the above, retest. An arterial blood specimen for laboratory CO-Oximetry analysis may be considered to verify the oxygen saturation and hemoglobin values. www.masimo.com 38 Masimo Pronto-7 Modes Chapter 4: Operation Pronto-7 is equipped with five modes; three sensitivity modes and two test modes. The sensitivity modes include normal, max and multi. The test modes include SpO2 only and Measure through Motion, identified on the Pronto-7 screen as measure under Low SIQ. If any of the three sensitivity modes are toggled to On, the Pronto-7 will remain in the test mode until the user manually configures the mode to Off, or if SpO2 only test mode is turned On, as this test mode overrides all sensitivity modes. Measure through Motion test mode can be turned on and used simultaneously with any of the four other modes. If either of the two test modes is toggled to On, the Pronto-7 will remain in this test mode until the user manually configures the mode to off. All modes can be accessed from the Main Menu icon. Some modes can be accessed in additional ways. Sensitivity Modes Details Normal is the default sensitivity mode for the Pronto-7. Max sensitivity mode should provide fewer Test Incomplete messages compared to normal sensitivity mode. Multi test mode provides an averaged result based upon three tests. Pronto-7 will perform multiple individual tests until three quality samples are obtained which will be averaged for the single test result. Test Modes Details SpO2 only test mode displays SpO2, PI and PR only. Using this mode does not consume a spot check test. If SpHb is needed after the SpO2 only mode test is complete the user can access SpHb, which will deduct a spot check test. See Accessing SpHb in SpO2 Only Test Mode on page 4341 for details. If SpO2 only test mode is on, the Pronto-7 will remain in this test mode until the user manually configures the mode to off. See Accessing Sensitivity and Test Modes on page 4139 for details. Measure through Motion mode allows for fewer incomplete tests and can be enabled from the Test Mode icon. If Measure through Motion test mode is on, the Pronto-7 will remain in this test mode until the user manually configures the mode to off. See Accessing Sensitivity and Test Modes on page 4139 for details. www.masimo.com 39 Masimo Pronto-7 Chapter 4: Operation Mode Accuracy under no motion conditions Accuracy under Measure Through Motion Test Mode Notes Normal ARMS accuracy over 6-18 g/dL: 1.1 g/dL ARMS accuracy over 8-17 g/dL: 1.0 g/dL ARMS accuracy over any range is 1.5 g/dl Default mode for Pronto-7 MAX ARMS accuracy over 4.5-20 g/dL: 1.1 g/dL ARMS accuracy over any range is 1.5 g/dl MAX sensitivity mode should provide less Test Incomplete messages compared to the Normal Sensitivity Mode Multi ARMS accuracy over 6-18 g/dL: 1.1 g/dL ARMS accuracy over 8-17 g/dL: 1.0 g/dL ARMS accuracy over any range is 1.5 g/dl
- In multi test mode, Pronto-7 will perform multiple individual tests until three quality samples are obtained which will be averaged for a single test result. www.masimo.com 40 Masimo Pronto-7 Chapter 4: Operation Mode Accuracy under no motion conditions Accuracy under Measure Through Motion Test Mode Notes SpO2 Only ARMS accuracy over 6-18 g/dL: 1.1 g/dL ARMS accuracy over 8-17 g/dL: 1.0 g/dL ARMS accuracy over any range is 1.5 g/dl When SpO2 Only mode is On, Normal, Max and Multi sensitivity modes will be overridden. SpHb measurements are only accessible by pressing SpHb measurement following SpO2 Only measurement. Accessing Sensitivity and Test Modes All modes can be accessed from the main menu. To access modes;
1. Tap the Main Menu icon. 2. Tap the Settings icon. 3. Tap the Test Mode icon. 4. Toggle the mode to the desired test mode 5. Tap the green check mark icon to accept changes www.masimo.com 41 Masimo Pronto-7 Chapter 4: Operation Accessing Multi Sensitivity Mode In addition to accessing multi sensitivity mode from the main menu, it can also be accessed directly from a Test Results screen upon completion of a spot check test. To test in multi sensitivity mode upon successful completion of a spot check test:
1. Tap the Multi icon to transition into multi test mode. 2. The Pronto-7 will direct you to complete the following steps:
Remove the sensor completely. Reattach the sensor to the same finger and verify correct positioning. Tap Continue to conduct the second of three tests. Repeat steps 2-3 for the final third test. www.masimo.com 42 Masimo Pronto-7 Chapter 4: Operation Accessing SpHb in SpO2 Only Test Mode SpHb is needed after the SpO2 only mode test is complete the user can access SpHb, which will deduct a test credit. To access SpHb in this mode, the user can tap the SpHb icon on the left side of the screen. This will provide the SpHb reading, and a spot check credit will be deducted. If www.masimo.com 43 Masimo Pronto-7 Chapter 4: Operation Emailing Spot Check Test Results In order to email spot check test results, the user must first have an online account for the Pronto-7. 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. 4. In the Sponsor Key field, enter the word email. If registration is successful, your user name and password information is saved. Retain this information for your records. Configuring Outgoing Email Settings 1. From the Main Menu on the Pronto-7, navigate to the Connections icon. 2. From the Connections icon, navigate to the Outgoing Email screen. 3. Enter the user name and password for the Pronto7.com account. 4. In the Reply-To Address field, enter an appropriate email address for receiving responses. In the Attach Image field, choose Yes if the test results screen image should be attached to an outgoing email. In the Attach .CSV field, choose Yes if the test results spreadsheet should be attached to an outgoing email. 5. 6. 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 send all test results to a single email address icon. 1. Tap the 2. Tap the Email All Tests icon. 3. Enter email address to which the test results will be sent. 4. Tap the Accept icon. To send individual test results Tap the icon. 1. Tap the Email Single Test icon. 2. Enter email address to which the test results will be sent. www.masimo.com 44 Masimo Pronto-7 Chapter 4: Operation 3. Tap the Accept icon. www.masimo.com 45 Masimo Pronto-7 Chapter 4: Operation Download of Spot Check Tests Purchased spot check tests can be wirelessly or non-wirelessly downloaded to the Pronto-7 sensor. The number next to the radical sign indicates the quantity of remaining tests left on the sensor. To download spot check tests directly using the Pronto-7, the instrument must be connected to a wireless network. There are two ways to access wireless download of spot check tests, either from the Main Menu icon or the radical sign. Main Menu:
1. Connect Pronto-7 to a wireless network by accessing the Connections icon from the Main Menu icon, see Main Menu Access on page 5148. 2. Connect the sensor to the Pronto-7. 3. Tap the Main Menu icon. 4. Tap the Help icon. 5. Tap the Load Tests icon. 6. Tap the Download icon. Radical Sign:
1. Connect Pronto-7 to a wireless network by accessing the Connections icon from the Main Menu icon, see Main Menu Access on page 5148. 2. Connect the sensor to the Pronto-7. 3. Tap the radical sign at the top left corner of the Test Ready screen. 4. Tap the Download icon. The following image and table explains the various features and displays of wireless spot check test download once the Download icon is accessed. www.masimo.com 46 Masimo Pronto-7 Chapter 4: Operation Step Features /
Display Description 1 2 Tests Remaining Number of tests remaining on the connected sensor. Tests Available Number of tests purchased and available for download. 3 Quickload Tests Selectable shortcuts to download preset quantities of tests (10, 25, 50, 100, 250 or 500 tests). 4 Manual Load Download user-specified quantities of tests. 5 Automation Settings Auto downloads a minimum quantity of tests based on a user-specified threshold. To begin the download, using either Quickload or Manual Load:
1. Select one of the following:
Quickload: Tap on one of the quantity icons to indicate the quantity of tests to download. Manual Load: Tap the Manual Load icon, enter a specific quantity of tests to download in the new screen and tap Accept. 2. When prompted to verify the number of tests to be downloaded, if the number is correct, tap Yes. 3. When the tests are being downloaded, the message Please Wait displays in the bottom-left corner of the screen. When the tests are www.masimo.com 47 Masimo Pronto-7 Chapter 4: Operation downloaded, the message Download Complete appears. To close this message, tap
. Using a Micro_SD Card:
1. Connect a compatible sensor to the Pronto-7. 2. Insert the micro SD card with spot check tests on it into the Pronto-7 micro SD card slot. 3. Tap the Main Menu icon on the Test Ready screen. 4. Tap the Help icon. 5. Tap the Load Tests icon, and finally tap the micro SD Load icon. After pressing the Load icon a dialog will appear confirming the tests have been successfully loaded. Using a USB Cable:
1. Connect a compatible sensor to the Pronto-7. 2. 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). 3. When the Pronto-7 is visible as a drive, drag the purchased spot check tests file into the Pronto-7 drive. 4. Once the file has completed downloading to the Pronto-7 drive, follow the computer's standard procedure to eject an external mass storage device. 5. After the file has downloaded to the instrument successfully and the Pronto-7 has been correctly ejected as a mass storage device, the USB cable can be disconnected from the instrument and the computer. 6. Tap the Main Menu icon on the Test Ready screen. 7. Tap the Help icon. 8. Tap the Load Tests icon, and then tap the Internal Mass Storage Load icon. After pressing the Load icon a dialog will appear confirming the tests have been successfully loaded.
*To protect the instrument, connect only to a medical grade computer to ensure grounding is sufficient. Use only the included mini USB to USB cable. Note: If multiple Spot Check test files have been purchased, it is important to load the test files in sequential order (i.e. test files purchased April 3, 2010 prior to test files purchased April 15, 2010). Non-sequential loading of test files www.masimo.com Masimo 48 Pronto-7 Chapter 4: Operation will obsolete any skipped test files. If test files are available in different locations (one on the micro SD and one on the Internal Device Storage) the Pronto-7 will only allow you to load the oldest files. After the oldest file is loaded, then the next most recent spot check test file can be loaded. To confirm that new tests have been downloaded to the sensor, the test count in the upper-left corner of the screen should be automatically increased by the number of tests downloaded. EMR Connectivity The Pronto-7 can wirelessly connect to compatible EMR systems, allowing test results to be sent to onsite EMR systems automatically. EMR connectivity is supported by Telcor and Apex. Contact your local Masimo sales representative for available EMR system compatibility. To enable this feature, Pronto-7 must be connected to a wireless network and EMR Connectivity settings must be configured in the EMR Connectivity icon as seen in the following image. www.masimo.com 49 Masimo Pronto-7 Chapter 4: Operation Uploading of files to the EMR can be performed manually or automatically. Manual Upload:
1. Tap the Main Menu icon. 2. Tap the Connections icon. 3. Tap the EMR Connectivity icon. 4. Populate the Server and Port settings depending on the specific EMR setup on-site. 5. Tap Send Results. 6. Tap the green check mark icon to accept changes. Automatic Upload:
1. Tap the Main Menu icon. 2. Tap the Connections icon. 3. Tap the EMR Connectivity icon. 4. Toggle the EMR Connection to On. 5. Populate the Server and Port settings depending on the specific EMR setup on-site. 6. Tap the green check mark icon to accept changes. After each complete spot check test the file will be uploaded to the EMR. Consult Masimo Technical Services for EMR connectivity support and maintenance. www.masimo.com 50 Masimo Pronto-7 Main Menu Options Chapter 4: Operation The following section outlines all Main Menu features available on the Pronto-7 and user configurable options. Main Menu Access To access the Main Menu:
1. Tap 2. The Main Menu icon allows access to the following icons. from any screen where it is shown. Test Results Sounds Connections Device Diagnostics Display Settings Help 3. To access these icons, tap the needed icon. www.masimo.com 51 Masimo Pronto-7 Test Results Icon Chapter 4: Operation The test results icon provides the date of patient testing, the patient ID and the results produced. Sortable by column, data can be rearranged by pressing the column header to sort. The data cannot be sorted by Results. Option Factory Default Configurable Settings Date Descending Ascending or descending Patient ID Patient ID Ascending or descending Results Most recent tests N/A To access the patient and test details:
1. Tap the row of the patient in which data is needed. The details will be visible in a pop-up window. 2. Tap the Page 2 icon where available for remaining measurements or tap the icon to return to the Test Results icon details. From the test results icon a user can tap the 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. Sound Icon The sound icon provides volume, sound effect and voice controls. Option Factory Default Configurable Settings Volume 10 Sound Effects On www.masimo.com 1 - 10 On, Off 52 Masimo Pronto-7 Chapter 4: Operation Option Factory Default Configurable Settings Voice On On, Off Connections Icon Connections should be created or modified by an administrator familiar with wireless networking and it is recommended that the instrument be connected to a secure wireless network. With an appropriately setup network, completed test result screens can be emailed or printed and spot check tests can be downloaded. Printing can be done over an internet connection or through a Bluetooth printer (Bluetooth barcodes can be included). Option Factory Default Wireless Network Configurable Settings Wireless Connection LAN Configuration Off On, Off DHCP DHCP, Static Available Networks Available networks list User selectable from list New Network N/A Outgoing Email User Name Password N/A N/A User selectable (SSID, Security On, Off, encryption key WEP64, WEP-128, WPA-TKIP, WPA2-AES, Network password key) Enter Masimo server name Enter Masimo server password Reply to Address N/A User editable (About Owner screen) www.masimo.com 53 Masimo Pronto-7 Option Chapter 4: Operation Factory Default Configurable Settings Attach Image
(test screen shot) Attach .CSV
(.csv data file) No Yes, No 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 EMR Connectivity EMR Connection Off On, Off Server Port Upload all test results N/A N/A N/A www.masimo.com User editable User editable Tap to send all pending results to EMR. 54 Masimo Pronto-7 Device Diagnostics Icon Chapter 4: Operation Option Factory Default Configurable Setting Interference Scan N/A Display Icon Check Environment for Interference Option Factory Default Configurable Settings Brightness 10 1 - 10 SpHb Units of Measure g/dL g/dL, g/L, mmol/Ls, SpHct (%) Display Parameters SpHb, SpO2, PR, PI SpHb, SpO2, PR, PI, SpHct
*Finger Temp. Off C, F, Off
*Note: The temperature displayed is the temperature of the finger where the sensor is placed. This is not the patients core body temperature and should not be used to make clinical decisions. Settings Icon Option Factory Default Configurable Settings Test Mode Measure under Low SIQ No Yes, No Sensitivity Normal MAX, Normal, Multi SpO2 Test Mode Off On, Off User ID/Patient ID/PIN www.masimo.com 55 Masimo Pronto-7 Option User ID Patient ID Pin# Protection Test Menu Chapter 4: Operation Factory Default Configurable Settings Off Off Off Off Off On, Off On, Off On, Off On, 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 N/A www.masimo.com 56 Masimo Pronto-7 Option Chapter 4: Operation Factory Default Configurable Settings Information About Owner Registered to information Name, street address, cite, state, country, phone number, email, website Restore Settings Restore Default Settings N/A Help Icon No, Yes Option Description Quick Start Presents short slide show of basic testing operation Common Questions List of questions and answers about the instrument features Contact Tech Support Equipment Report Software Update Load Tests Specifies Masimo Tech Support contact information Documents device serial number, software version, total device run time, last service/location, sensor serial #, total sensor run time, spot checks administered and remaining Provides access to upgrade or downgrade the software version from one of four locations: micro SD, internal mass storage, compatible sensor or wireless network Provides access Load Tests - Select to view available spot check test files and/or load them in to the a compatible sensor Clear Database Supplies access to erase all measurements and patient/user database Device Allows download of latest configurations of Pronto-7 that is available, displays a list of features enabled based on www.masimo.com 57 Masimo Pronto-7 Chapter 4: Operation Option Configurations Description existing configuration of the instrument Battery Battery Level Indicator The Pronto-7 is powered by a rechargeable lithium polymer battery. It can also be powered by AC power, when used with the included AC power cable. Battery charge level is indicated by the battery icon in the upper right hand corner of the LCD touchscreen. 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 Alarm If the battery power level is too low, the instrument will not allow a test to be taken. There will be a visual display, indicating the AC power cable must be used to continue. WARNING: Failure to plug in the AC power cable promptly after a low battery alarm may result in the instrument shutting down. WARNING: Only use the included AC power cable. Using a different AC power cable could cause damage to the Pronto-7. www.masimo.com 58 Masimo Pronto-7 Checking Battery Status Chapter 4: Operation Tap the battery icon at any time to see the current battery status. www.masimo.com 59 Masimo Chapter 5: Alarms and Messages Messages The Pronto-7 will indicate other data or system errors. Messages are:
Message Possible Indication Recommendation Ready Ready for spot check test Initiate spot check test by pressing the green Test icon. Connect Sensor No compatible sensor is connected Connect a compatible sensor to the instrument. Test Incomplete Sensor disconnect or interference Check sensor connection or perform interference scan. Low Battery Warning Pronto-7 battery is too low at start of measurement Plug in Pronto-7 AC power cord. Test Stopped Stop icon is pressed during test Initiate new spot check test by pressing the green Test icon. www.masimo.com 61 Masimo Chapter 6: Troubleshooting Troubleshooting The following chart describes what to do if the Pronto-7 system does not operate properly or fails. Problem Possible Sources Recommendation(s) 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 sensor DFU figure). Excessive motion Minimize or eliminate patient movement at the sensor site. Incomplete test or no reading 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 Main Menu (see Device Diagnostics Icon on page 5551). 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 or acrylic nails Remove all nail polish. Remove acrylic nails. www.masimo.com 63 Masimo Pronto-7 Problem Device does not power on Possible Sources Low battery Compatible sensor does not connect to instrument Sensor orientation is incorrect A computer connected with the included USB cable does not recognize the Pronto-7 Connection issue Chapter 6: Troubleshooting Recommendation(s) Plug in included AC power cable, then power on the instrument. The sensor can only connect one way. Make sure the sensor plug is oriented correctly, according to the sensor DFU and on-screen directions and diagrams. Make sure the instrument is powered on and plugged into AC power. Check the available drives on your computer. If the Pronto-7 still does not appear, search your computer's User Manual for proper external drive mapping and troubleshooting. Touchscreen icons do not respond when pressed System failure Turn off the instrument and then power it on. If the problem reoccurs or persists return for service. See Service and Repair on page 7167. www.masimo.com 64 Masimo Formatted Table Chapter 7: Specifications Specifications Measurement Range SpHb (total hemoglobin) 2 - 25 g/dL PR (pulse rate) 30 - 240 bpm SpO2 (arterial oxygen saturation) 0 - 100%
PI (perfusion index) 0.02 - 20%
SpHct (hematocrit) 5 - 75%
Accuracy Arterial Oxygen Saturation, 70%
to 100% [1]
2% ( 3% under motion) Pulse Rate [2]
3 bpm ( 5 bpm under motion) Total Hemoglobin Concentration
(SpHb g/dL) for 4D DC Sensor
[3]
Normal and Multi Sensitivity Modes ARMS accuracy over 6-18 g/dL: 1.1 g/dL ARMS accuracy over 8-17 g/dL: 1.0 g/dL MAX Sensitivity Modes ARMS accuracy over 4.5 - 20 g/dL: 1.1 g/dL Note: For all sensitivity modes under motion, ARMS accuracy over any range is 1.5 g/dL. Resolution SpHb (total hemoglobin) 0.1 g/dL PR (pulse rate) SpO2 (Arterial Oxygen Saturation) www.masimo.com 1 bpm 1 %
65 Masimo Chapter 7: Specifications Pronto-7 PI (perfusion index) SpHct 0.01%
1 %
Interfering Substances Refer to Safety Information, Warnings, and Cautions on page 99. Product Test storage capacity 8000 Wireless connectivity 802.11 b/g, Bluetooth Reporting modes Print, email, audible, micro SD Report formats Single test, multiple test, device summary Reporting devices Electrical Battery Power Capacity Optional Bluetooth thermal printer, USB 802.11 wireless (PCL5, 5e 6), or Bluetooth printing to validated printers Rechargeable lithium polymer Approximately 2 hours after full charge Number of spot checks on fully charged battery 140 Battery charging time Isolation AC Power Environmental 5 hours when powered off 6 hours when powered on Medical Grade AC/DC Adapter 100-240V, 50-60 Hz, 15VA max. System Operating Temperature 41F to 104F (5C to 40C) www.masimo.com 66 Masimo Pronto-7 Chapter 7: Specifications Storage Temperature
-40F to 158F (-40C to 70C) Operating Humidity 5% to 95%, non-condensing Operating Altitude 500 mbar to 1060 mbar
-1000 ft to 18,000 ft (-304 m to 5,486 m) Physical Characteristics Dimensions 5.1" x 2.8" x 1"
(13 cm x 7.2cm x 2.5 cm) Weight 10.5 oz (296.4 g) Visual Alarm Low Battery, System Failure Display / Indicators Data display: SpO2%, PR beats per minute, SpHb g/dL, PI%, SpHct %, wifi status, Bluetooth status, time, date, spot check tests remaining, sensor size, battery level indicator, pulse plethysmograph waveform, action icons. Type 3.7" Resistive Touchscreen Compliance EMC Compliance EN60601-1-2, Class B Equipment Classification IEC 60601-1 Type of Protection (battery power) Internally Powered Type of Protection (AC Power) Class 2 Degree of Protection-Sensor Type BF-Applied Part Mode of Operation Spot Check www.masimo.com 67 Masimo Pronto-7 Chapter 7: Specifications
[1] The SpO2 accuracy has been validated in human blood studies on healthy adult male and female volunteers 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.
[2] Masimo sensors have been validated for pulse rate accuracy for the range of 30-240 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.
[3] The SpHb accuracy has been validated with (arterial / venous) blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation in the range of 4.5 20 g/dL, - 6-18 g/dL and 8-17 g/dLSpHb against a laboratory CO-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. Calibration Verification Pronto-7 does not require calibration during clinical use. The calibration coefficients are embedded in the software and validated during manufacturing testing in compliance with Masimos 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. If any component of the system is not operating within specification, the monitor will not allow a test to be performed and will alarm and display an error code message. In this case, contact your Masimo representative and return the device for service. Symbols The following symbols may be found on the Pronto-7 or packaging and are defined below:
Symbol Description Caution, consult accompanying documents www.masimo.com 68 Masimo Chapter 7: Specifications Pronto-7 Symbol Description Follow Instructions for Use Type BF applied part complying with IEC 60601-1 Separate collection for electrical and electronic equipment
(WEEE) Mark of Conformity to European Medical Device Directive 93/42/EEC Federal law restricts this device to sale by or on the order of a physician (USA audiences only) Date of manufacture Storage humidity range: 5% to 95%
Storage temperature range: +70C to -40C Storage altitude range: 500 mbar to 1060 mbar Keep dry Fragile/breakable, handle with care www.masimo.com 69 Masimo Pronto-7 Symbol Description Chapter 7: Specifications MDSS GmbH, Schiffgraben 41, D-30175 Hannover, Germany Manufacturer ETL Wireless features can be used in member states with the restriction of indoor use in France Federal Communications Commission (FCC) licensing Non-ionizing electromagnetic radiation Protection against vertically falling water drops No parameter alarms www.masimo.com 70 Masimo Chapter 8: Service and Repair Service and Repair Introduction This chapter covers how to properly clean and obtain service for the Pronto-7. Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only. The Pronto-7 is a reusable instrument. The instrument is supplied non-sterile. Cleaning The outer surface of the Pronto-7 can be cleaned with a soft cloth dampened with a mild detergent and warm water solution. Do not allow liquids to enter the interior of the instrument. The outer surface of the instrument can also be wiped down using the following solvents: Cidex Plus (3.4% Glutaraldehyde), 0.25% Ammonium Chloride, 10% Bleach, 70% Isopropyl Alcohol. WARNING: Before cleaning the instrument, always turn it off. CAUTIONS:
1. Do not sterilize the Pronto-7. 2. Do not soak or immerse the Pronto-7 in any liquid. 3. Use the cleaning solution sparingly. Excessive solution can flow into the Pronto-7 and cause damage to internal components. 4. Do not touch, press, or rub the display panels with abrasive cleaning compounds, devices, brushes, rough-surface materials, or bring them into contact with anything that could scratch the panel. 5. Use the included LCD cleaning cloth to remove fingerprints from the touchscreen. 6. Do not use petroleum-based, acetone solutions, or other harsh solvents, to clean the Pronto-7. 7. These substances erode the instruments materials and instrument failure can result. For cleaning instructions of the sensor, refer to the appropriate sensor Directions for Use. www.masimo.com 71 Masimo Repair Policy Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the instrument repaired prior to use. WARNING: An operator may only perform maintenance procedures specifically described in this manual. Refer servicing to qualified service personnel trained in the repair of this equipment. To return the Pronto-7 for service, please follow the Return Procedure. Return Procedure Remove all saved patient identifying data by deleting all tests (For configuration details, see Main Menu Options on page 5147 ). Please clean contaminated/dirty equipment (See Cleaning on page 7167) before returning and make sure it is fully dry before packing the equipment. Call Masimo Technical Services to request return authorization (RMA), at the phone number below. Package the equipment securely in the original shipping container if possible and enclose or include the following information and items:
1. A letter describing in detail any difficulties experienced with the Pronto-7. Please include the RMA number in the letter. 2. Warranty information a copy of the invoice or other applicable documentation must be included. 3. Purchase order number to cover repair if the instrument is not under warranty, or for tracking purposes if it is. 4. Ship-to and bill-to information. 5. Person (name, telephone / telex / fax number, and country) to contact for any questions about the repairs. 6. A certificate stating the Pronto-7 has been decontaminated for bloodborne pathogens. www.masimo.com 73 Masimo Pronto-7 Chapter 8: Service and Repair All other locations Contact your local Masimo Representative Return the Pronto-7 to the following shipping address:
USA, Canada, Asia Pacific (except Japan) Japan Europe Masimo Corporation 40 Parker Irvine, California 92618 Tel: 949-297-7498, or 800-326-4890 (option 2) Fax: 949-297-7499 Masimo International Srl Puits-Godet 10 2000 Neuchatel Switzerland Tel: +41 32 720 1111 Fax: +41 32 724 1448 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 Sales & End-User License Agreement 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. www.masimo.com 74 Masimo Pronto-7 Warranty Chapter 8: Service and Repair Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: each new Product and the Software media as delivered are free from defects in workmanship or materials. Batteries are warranted for six (6) months. To request a replacement under warranty, Purchaser must contact Masimo for a returned goods authorization. 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 shall be the responsibility of Purchaser. Masimos sole obligation under this warranty is to repair or replace any Product or Software that is covered under warranty. www.masimo.com 75 Masimo Pronto-7 Exclusions Chapter 8: Service and Repair The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or maintenance needed because of: a) modification of the Product or Software without Masimos written authorization; b) supplies, instruments or electrical work external to the Product or not manufactured by Masimo; c) disassembly or reassembly of the Product by anyone other than an authorized Masimo agent; d) use of the Product with Sensors or other accessories other than those manufactured and distributed by Masimo; e) use of the Product and Software in ways or in environments for which they are not labeled; and f) neglect, misuse, improper operation, accident, fire, water, vandalism, weather, war, or any act of God. This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product. This warranty does not extend to any Product that has been reprocessed, reconditioned or recycled. This warranty also does not apply to any Products provided to Purchaser for testing or demonstration purposes, any temporary Products Modules or any Products for which Seller does not otherwise receive a usage or purchase fee;
all such Products are provided AS-IS without warranty. This warranty, together with any other express written warranty that may be issued by Masimo is the sole and exclusive warranty as to the Product and Software. This warranty is expressly in lieu of any oral or implied warranties, including without limitation any implied warranty of merchantability or fitness for a particular purpose. Masimo shall not be liable for any incidental, special or consequential loss, damage or expense directly or indirectly arising from the use or loss of use of any Products or Software. In no event shall Masimos liability arising from any Product and Software (under contract, warranty, tort, strict liability or other claim) exceed the amount paid by purchaser for the Products giving rise to such claim. The limitations in this section shall not be deemed to 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 Purchasers 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 www.masimo.com 76 Masimo Pronto-7 Chapter 8: Service and Repair 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 Purchasers 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 instrument. 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 Purchasers 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. www.masimo.com 77 Masimo Pronto-7 No Implied License Chapter 8: Service and Repair 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. Sensors Licensed for Monitoring Use Only Sensors designated for monitoring only are licensed to you under patents owned by Masimo to be used for patient monitoring, in an unmodified form as originally received from Masimo, and no license is granted to have Masimos 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 www.masimo.com 78 Masimo Index A About this Manual 5 Accessing Multi Sensitivity Mode 40 Accessing Sensitivity and Test Modes 37, 39 Accessing SpHb in SpO2 Only Test Mode 37, 41 Arterial Oxygen Saturation
(SpO2) 23 B Battery 54 Battery Level Indicator 54 C Calibration Verification 64 Chapter 1 Technology Overview 15 Chapter 2 Product Description 19 Chapter 3 Setup 25 Chapter 4 Operation 27 Chapter 5 Alarms and Messages 57 Chapter 6 Troubleshooting 34, 59 Chapter 7 Specifications 61 Chapter 8 Service and Repair 67 www.masimo.com Checking Battery Status 55 Cleaning 67, 69 Common Screens 28 Commonly Used Icons 28 Completed Test 34 Compliance Information, Warnings and Cautions 13 Connections Icon 50 Contraindications 7 D Device Diagnostics Icon 51, 59 Display Icon 51 Download of Spot Check Tests 43 E Emailing Spot Check Test Results 34, 42 EMR Connectivity 46 End User License 71 Exclusions 70 F Functional Oxygen Saturation 16 H Help Icon 53 Hematocrit (SpHct) 24 I Incomplete Test 34 Indications for Use 7 Introduction 67 79 Masimo Pronto-7Pronto-7 K Key Features 35 L Low Battery Alarm 55 Low Signal I.Q. (Low SIQ) 33, 36 M Main Menu Access 43, 48 Main Menu Options 35, 47, 69 Messages 57 Modes 37 N No Implied License 72 Non-Invasive Total Hemoglobin
(SpHb) Accuracy Compared to Invasive Laboratory Methods*
17 P Parameter and Measurement Descriptions 23 Patient Testing 32 Performing a Test 31 Perfusion Index (PI) 24 Preparation for Use 25 Product Description 7 Pronto-7 Back Panel 22 Pronto-7 Bottom Panel 23 Pronto-7 Description 19 Pronto-7 Front Panel and Touchscreen 20 www.masimo.com Index Pronto-7 vs. Drawn Whole Blood Measurements 16 Pulse Rate (PR) 24 R rainbow 4D DC Reusable Sensor 17 rainbow Pulse CO-Oximetry Technology 15 Recommended Initial Testing Procedure 30 Repair Policy 69 Restrictions 71 Return Procedure 25, 69 S Safety Information, Warnings, and Cautions 9, 10, 62 Sales & End-User License Agreement 70 Sensor Information, Warnings and Cautions 14 Sensor Placement 31 Sensor Selection 30 Sensor Site Selection 30 Sensors Licensed for Monitoring Use Only 72 Service and Repair 60, 67 Settings Icon 52 Signal Extraction Technology
(SET) 15 Sound Icon 25, 49 Specifications 61 SpHb Spot Check Measurement 30, 34 80 Masimo Index Pronto-7Pronto-7 Symbols 64 T Test Results Icon 48 Total Hemoglobin (SpHb) 23 Troubleshooting 59 U Unpacking and Inspection the System 25 Using a Micro_SD Card: 44 Using a USB Cable: 45 V Viewing Select Parameters 35 Viewing SpHct 35 W Warranty 70 www.masimo.com 81 Masimo www.masimo.com 33492/LAB-5621S 0214
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2014-02-24 | 2412 ~ 2462 | DSS - Part 15 Spread Spectrum Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2014-02-24
|
||||
1 | Applicant's complete, legal business name |
Cercacor Laboratories, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0019504166
|
||||
1 | Physical Address |
189 Technology Dr
|
||||
1 |
Irvine, California 92618
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@intertek.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
X44
|
||||
1 | Equipment Product Code |
PRONTO7A
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
H**** C****
|
||||
1 | Telephone Number |
949-6********
|
||||
1 | Fax Number |
949-6********
|
||||
1 |
h******@cercacor.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DSS - Part 15 Spread Spectrum Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Pronto-7 Spot Check Pulse CO-Oximeter | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power output listed is conducted. SAR compliance for portable use conditions has been evaluated as described in this filing. This device must not be co-located or operating in conjunction with any other antenna or transmitter except as described in this composite filing. End-users must be informed of the operating requirements for satisfying RF exposure compliance. The highest reported SAR value is 0.011 W/kg. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Intertek Testing Services NA
|
||||
1 | Name |
J**** S****
|
||||
1 | Telephone Number |
859-2********
|
||||
1 | Fax Number |
859 2********
|
||||
1 |
j******@intertek.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412 | 2462 | 0.03 | ||||||||||||||||||||||||||||||||||||
1 | 2 | 15C | 2412 | 2462 | 0.017 | ||||||||||||||||||||||||||||||||||||
1 | 3 | 15C | 2402 | 2480 | 0.00163 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC