Operators Manual
4 Pages
Preview
Page 1
MightySatTM Rx Fingertip Pulse Oximeter Operator's Manual Not for Sale in the USA - For Export Only 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. Cleared Use Only: The device and related accessories have obtained CE Mark for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the instructions for use or labeling.
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Caution: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to MightySat Rx. Caution: High ambient light sources, fluorescent lights, infrared heating lamps and direct sunlight can interfere with the performance of MightySat Rx. Caution: To prevent interference from ambient light, ensure that MightySat Rx is properly applied. Failure to take this precaution in high ambient light conditions may result in inaccurate or no measurements. Caution: When using MightySat Rx (optional Bluetooth version) with a smart device, keep both devices within the recommended range of each other (see Specifications for details); moving outside of this range may cause a loss in connection with the smart device. Note: The MightySat Rx display may be difficult to view when exposed to direct sunlight or bright lights. Note: A functional tester cannot be used to assess accuracy of MightySat Rx. Note: The MightySat Rx display will shut off automatically if there are no readings.
About this Manual
Cleaning and Service Warnings and Cautions
Do not operate the MightySat Rx Fingertip Pulse Oximeter without completely reading and understanding the instructions. Always use the MightySat Rx precisely in accordance with the directions in this manual, including site selection and sensor placement. Failure to follow all of the directions in this manual could lead to inaccurate measurements. 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 to the patient or user (for example, injury, serious adverse effect, or death). 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 instrument, or damage to other property. Caution: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note.
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Product Description and Indications Product Description The MightySat Rx Fingertip Pulse Oximeter is a noninvasive device that measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), Perfusion Index (PI), and optional Pleth Variability Index (PVI®). The MightySat Rx is available for patients who weigh more than 30 kg (66 lbs). The following key features are available for the MightySat Rx: Masimo SET® technology for SpO2 and pulse rate monitoring in motion and low perfusion environments. • Optional Bluetooth® LE wireless technology for the wireless transfer of patient data to smart devices. The MightySat Rx Fingertip Pulse Oximeter is available in the following versions: •
Product Versions
Features
MightySat Rx
Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), and Perfusion Index (PI).
MightySat Rx, Bluetooth
Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), and Perfusion Index (PI).
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Compliance Warnings and Cautions • • •
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Optional Bluetooth LE radio for transfer of parameter data to a compatible smart device. MightySat Rx, Bluetooth and PVI
Warning: Use only AAA alkaline batteries. Warning: Alkaline batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for more than 30 days. Warning: Do not mix fully charged and partially charged batteries at the same time. These actions may cause the batteries to leak. Caution: An operator may only perform maintenance procedures specifically described in the manual; otherwise, return MightySat Rx for servicing. Caution: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean MightySat Rx. These substances affect the device’s materials and instrument failure can result. Caution: Do not submerge MightySat Rx 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: Do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any cleaning solution other than those recommended here because permanent damage to MightySat Rx may occur. Caution: Never immerse MightySat Rx in water or any other liquid solution.
Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), Perfusion Index (PI), and optional Pleth Variability Index (PVI). Optional Bluetooth LE radio for transfer of parameter data to a compatible smart device.
Indications for Use
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. Caution: Disposal of Product: Comply with local laws in the disposal of the instrument and/or its accessories, including batteries. Note: When using MightySat Rx with optional Bluetooth LE, consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless devices. Note: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. Note: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. Note: This equipment has been tested and found to comply with the Class B limits for medical devices according to the IEC 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.
The MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
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Safety Information, Warnings, and Cautions
Technology Overview
Safety Warnings and Cautions
The following chapter contains general descriptions about parameters, measurements, and the technology used by Masimo products.
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Warning: Do not use MightySat Rx if it appears or is suspected to be damaged. Warning: Do not repair, open, or modify MightySat Rx. Injury or equipment damage could occur. Warning: Do not use MightySat Rx during magnetic resonance imaging (MRI) or in an MRI environment. Warning: Do not expose MightySat Rx components to excessive moisture such as direct exposure to rain. Excessive moisture can cause the components to perform inaccurately or fail. Warning: Do not place MightySat Rx or accessories in any position that might cause it to fall on the patient. Warning: Electric Shock Hazard: Do not use MightySat Rx during defibrillation. Warning: Do not to use device during electrosurgery. Warning: Do not use MightySat Rx in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. Warning: Do not use tape to secure MightySat Rx to the site; this can restrict blood flow and cause inaccurate readings. Use of tape can cause skin damage, and/or pressure necrosis or damage the sensor. Warning: Keep the oximeter away from young children. Small items such as the battery door and battery may become choking hazards. Warning: When MightySat Rx is applied for extended periods of time, the sensor site must be checked frequently to ensure adequate circulation, skin integrity, and correct optical alignment. Warning: If MightySat Rx is applied too tightly or becomes tight due to edema it will cause inaccurate readings and can cause pressure necrosis. Warning: Do not use the lanyard with MightySat Rx during activities where a risk of strangulation may exist (i.e. sleeping). Caution: Do not attempt to reprocess, recondition or recycle MightySat Rx as these processes may damage the electrical components, potentially leading to patient harm. Caution: MightySat Rx contains a magnet which may interfere with other devices, including pacemakers. Note: The maximum skin surface temperature is measured to be less than 41°C (106°F) in a 35°C (95°F) environment. This was verified by measuring the skin interface temperature with MightySat Rx operating under reasonable worst-case conditions.
Performance Warnings and Cautions • •
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Warning: MightySat Rx is not an apnea monitor and should not be used for arrhythmia analysis. Warning: The MightySat Rx 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: MightySat Rx does not include visual alerts or audible alarm features to support continuous monitoring. It is intended for spot-check use only. Warning: SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). Warning: Inaccurate SpO2 readings may be caused by: • Improper MightySat Rx placement or alignment • 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. • Patients attached to a high pressure cuff • Avoid placing the MightySat Rx on any extremity with an arterial catheter or blood pressure cuff. • Elevated levels of bilirubin • Severe anemia • Venous congestion • Venous pulsation • Low arterial perfusion • Motion artifact
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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 filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform® (DST®), in parallel with Fast Saturation Transform (FST®), reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.
Masimo SET DST This figure is for conceptual purposes only.
General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: • •
Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry). The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
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MightySat Rx Fingertip Pulse Oximeter EU authorized representative for Masimo Corporation: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany Manufacturer:
Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com © 2015 Masimo Corporation
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Successful Monitoring for SpO2, PR and PI
Installing the AAA Batteries
Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is a relative term, experience will provide a good feeling for changes that are artifactual or physiological and the speed, timing, and behavior of each. The stability of the readings over time is affected by the averaging time being used. The longer the averaging time, the more stable the readings tend to become. This is due to a dampened response as the signal is averaged over a longer period of time than during shorter averaging times. However, longer averaging times delay the response of the oximeter and reduce the measured variations of SpO2 and pulse rate.
The MightySat Rx requires two alkaline AAA batteries to operate. To install batteries, follow the instructions below: 1.
Place the MightySat Rx so that the display screen is facing downwards. Find the battery button on the front of the sensor pad. Push lightly on the battery button to release the battery cover and then remove the battery cover. Insert two new AAA alkaline batteries and match the orientation labels (+ and -). Note: MightySat Rx will not work if the batteries are inserted in the incorrect orientation. Once the batteries are correctly inserted, snap the battery door back onto the device. Warning: Ensure that the battery door is intact before use. Note: MightySat Rx will turn on automatically when the device is opened so that the sensor pads are exposed as shown in the image below.
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Functional Oxygen Saturation (SpO2) The MightySat Rx is calibrated to measure and display functional oxygen saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. Note that dyshemoglobins are not capable of transporting oxygen, but are recognized as oxygenated hemoglobins by conventional pulse oximetry.
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General Description for Perfusion Index (PI) The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue. PI thus represents a noninvasive measure of peripheral perfusion that can be and noninvasively obtained from a pulse oximeter.
General Description for Pulse Rate (PR) Pulse rate (PR), measured in beats per minute (BPM) is based on the optical detection of peripheral flow pulse.
Using MightySat Rx To take readings with the MightySat Rx, follow the instruction below: Note: Before use, ensure batteries are correctly installed in the MightySat Rx.
General Description for Pleth Variability Index (PVI) The Pleth Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percentage (0-100%). Pleth Variability Index (PVI) may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions. The utility of PVI has been evaluated in clinical studies [1-11]. Technical and clinical factors that may affect PVI include probe malposition, probe site, patient motion, skin incision, spontaneous breathing activity, lung compliance, open pericardium, use of vasopressors or vasodilators, low perfusion index, subject age, arrhythmias, left or right heart failure, and tidal volume [12-14].
Citations for Pleth Variability Index (PVI) 1.
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4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.
Cannesson M., Desebbe O., Rosamel P., Delannoy B., Robin J., Bastien O., Lehot J.J. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008 Aug;101(2):200-6. Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg. 2010 Oct;111(4):910-4. Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B.M., Wiesenack C. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. Anesth Analg. The Ability of Pleth Variability Index to Predict the Hemodynamic Effects of Positive End-Expiratory Pressure in Mechanically Ventilated Patients under General Anesthesia. 2010 Mar 1;110(3):792-8. Tsuchiya M., Yamada T., Asada A. Pleth Variability Index Predicts Hypotension During Anesthesia Induction. Acta Anesthesiol Scand. 2010 May;54(5):596-602. Loupec T., Nanadoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene B., Dahyot-Fizelier C., Mimoz O. Pleth Variability Index Predicts Fluid Responsiveness in Critically Ill Patients. Crit Care Med. 2011 Feb;39(2):294-9. Fu Q., Mi W.D., Zhang H. Stroke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness during Resection of Primary Retroperitoneal Tumors in Hans Chinese. Biosci Trends. 2012 Feb;6(1):38-43. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. Anesth. 2012 Oct;26(5):696-701. Byon H.J., Lim C.W., Lee J.H., Park Y. H., Kim H.S., Kim C.S., Kim J.T. Br. J. Prediction of fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Anaesth 2013 Apr;110(4):586-91. Feissel M., Kalakhy R., Banwarth P., Badie J., Pavon A., Faller J.P., Quenot JP. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 2013 Oct;28(5):634-9. Yu Y., Dong J., Xu Z., Shen H., Zheng J. Pleth Variability Index-Directed Fluid Management in Abdominal Surgery under Combined General and Epidural Anesthesia. J Clin Monit Comput. 2014 Feb 21. Desgranges F.P., Desebbe O., Ghazouani A., Gilbert K., Keller G., Chiari P., Robin J.,Bastien O., Lehot J.J., Cannesson M. Br. J. Anaesth 2011 Sep;107(3):329-35. Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97. Takeyama M, Matsunaga A, Kakihana Y, Masuda M, Kuniyoshi T, Kanmura Y. Impact of Skin Incision on the Pleth Variability Index. J Clin Monit Comput 2011 Aug;25(4):215-21.
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To open the MightySat Rx, squeeze the back portion of the device as shown in the image above. Once the sensor pads are exposed, insert a finger (non-dominant, ring finger) so the sensor LED is above the fingernail. Note: The display screen of the MightySat Rx should be facing upwards as depicted in the image above. Once the finger is correctly positioned, gently close the MightySat Rx by releasing the pressure on the back of the device. Note: Ensure the finger is correctly positioned for accurate measurements. The tip of the finger should touch the finger stop as shown in the image below.
Once the MightySat Rx is correctly closed on the finger, the MightySat Rx will display readings. Note: If no readings are displayed, see Troubleshooting section in this manual. Warning: While on the finger, do not press the top of the device against any surface. Warning: Do not attempt to secure the MightySat Rx to the finger using external pressure. The internal spring provides the correct pressure; additional pressure may cause inaccurate readings.
Turning off MightySat Rx The MightySat Rx turns off automatically after removing the finger from the device in the absence of device interaction or connection to a smart device.
Using the Touchpad The Touchpad Note: The display is not a touch screen.
on MightySat Rx device is located below the display screen.
Action
Description
Function
Touch
Tap and release. Action will be performed once finger is released.
Select a menu item or action
Press and Hold
Press and hold. Release finger once action has been performed.
Enter and Exit the Main Screen
Swipe
Touch and slide (left, and right) and release.
Scroll through all selectable menu options.
Touch rotates the display clockwise
Getting Started with MightySat Rx MightySat Rx Features
Navigating the Menu From the Main Screen, press and hold the Touchpad to access the Main Menu. Use the Touchpad Swipe gesture to scroll through the Main Menu Options. Use the Touch gesture to select the Main Menu Option. Use the same gestures to adjust settings. The Menu options are: Main Menu Options ID
Description
Function
1
Enclosure Clip
Clip provided for ease of lanyard attachment.
2
Bluetooth Indicator (Optional)
Indicates when Bluetooth LE is enabled on the device.
3
Battery Status Indicator
Indicates the remaining relative life of the battery.
4
Display Screen
Display for measurements and indicators. Note: Numbers will dim when confidence in the value is low.
5
Waveform and SIQ or Pulse Bar
When the waveform option is turned on, the pleth waveform and the SIQ provides an indicator of the relative signal strength.
Description
Default
Options
Back
Return to Main screen
N/A
N/A
Waveform
Allows the user to choose if the waveform will be displayed on the screen.
On
On or Off
Brightness
Change the brightness of the display screen.
100%
25%, 50%, 75% and 100%
Bluetooth (Optional)
Allows the user to connect to a smart device via Bluetooth LE.
On
On or Off
About
Hardware and software information about the device including serial number, software version, and Bluetooth LE Mac Address.
N/A
N/A
When the waveform option is turned off, the pulse bar provides a blinking graphical indicator which corresponds to the pulse rate. Additionally, the relative signal strength is depicted by the height of the pulse bar. 6
Touchpad
User interface to allow for change of settings (see Using the Touchpad section in this manual).
Display Button
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Connecting to a Smart Device via Bluetooth (Optional)
Exclusions
Note: Bluetooth LE is an optional feature available on specific versions of MightySat Rx for use with compatible smart devices. For a full list of compatible smart devices, see www.masimoprofessionalhealth.com. 1. From your compatible smart device, do one of the following:
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.
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For Android -powered devices, go to the Google Play store. SM
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• For Apple® devices, go to the App Store . Search and download the “Masimo Professional Health” app. Follow on-screen instructions in the Masimo Professional Health app to pair MightySat Rx with a compatible smart device.
Cleaning and Service Cleaning MightySat Rx Warning: Before cleaning, read Cleaning and Service Warnings and Cautions section in this manual. Warning: Before cleaning, make sure the device is off and is not applied to a finger. Note: Before cleaning, remove the batteries and make sure the battery cover is reattached correctly. To clean the MightySat Rx, follow the instructions below: The outer surfaces can be cleaned either with a soft cloth dampened with a mild detergent and warm water solution or they can be wiped down with the following cleaning solutions: • Cidex Plus (3.4% glutaraldehyde) • 10% bleach solution • 70% isopropyl alcohol solution • Allow the MightySat Rx to dry thoroughly before using again. Caution: To avoid permanent damage to the MightySat Rx, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended. •
Service Warning: Do not attempt to repair the MightySat Rx as this may cause damage to the device and prevent it from operating properly. If the device does not appear to be operating correctly, see Troubleshooting section in this manual. Note: To maintain the proper functionality of the battery compartment and avoid possible damage from alkaline batteries that may leak, remove batteries from the device when not in use for long periods of time.
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. In so far as the above warranties cannot be disclaimed, Masimo limits the duration and remedies of the warranties to the duration and to the remedies set forth above and as permitted by law. 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.
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.
Restrictions 1.
Troubleshooting Error or Error Message
Possible Causes
Recommended Solutions
A red battery symbol displays on display screen
Low battery
Replace low batteries as soon as possible. (see Installing the AAA Batteries section in this manual)
Device does not display readings
Incorrect finger placement
Wait for measurement (Optional PVI may take up to 2 minutes before initial measurement)
Incorrect battery orientation No battery Low battery Environmental influences
Reposition finger (see Using MightySat Rx section in this manual)
2.
3.
Re-orient batteries Replace with new batteries Relocate device Contact Masimo Technical Services
Device display does not turn on
Numbers appear dim
No battery
Replace with new batteries
Device damaged
Contact Masimo Technical Services
Low battery
Check battery status indicator and replace batteries if necessary
Brightness set low
Check brightness setting in menu
Exposed to bright lights or sunlight
Device keeps turning off while on the finger
Relocate device so that it is not directly under bright lights
Incorrect finger placement
Reposition finger (See Using MightySat Rx section in this manual)
Measurement site may be poorly perfused
Contact Masimo Technical Services
Incorrect finger placement
Reposition finger (See Using MightySat Rx section in this manual)
Environmental influences
Relocate device
Device damaged
Replace with new batteries Contact Masimo Technical Services
Measurement does not display on the smart device using optional Bluetooth LE
Bluetooth LE not connected Compatible app not installed on smart device
4.
Confirm Bluetooth LE is on for the MightySat Rx and the smart device Confirm a compatible app is installed on the smart device
Device damaged
Close and re-launch the compatible app on the smart device
Smart device damaged
Check that MightySat Rx is paired to the correct smart device Contact Masimo Technical Services
Product Support For additional help, contact Masimo Technical Services at (949) 297-7498. Local contact information can be found at http://service.masimo.com.
Limited Warranty Masimo warrants to the original end-user purchaser the Masimo-branded hardware product MightySat Rx Fingertip Pulse Oximeter 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 48 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. The above described warranty is in addition to any statutory rights provided to Purchaser under applicable laws and regulations of the region in which the product was sold to the extent that those rights cannot be disclaimed and are superseded by the above described warranty to the extent permitted under applicable laws and regulations of the region in which the product was sold.
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. 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. 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. 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.
Specifications Performance Specifications SpO2 Accuracy* Condition
Range
Population
ARMS
No Motion [1]
70% to 100%
Adults, Pediatrics
2%
Motion [2]
70% to 100%
Adults, Pediatrics
3%
Low perfusion [3]
70% to 100%
Adults, Pediatrics
2%
*See the SpO2 Performance Specifications section for additional SpO2 accuracy information. Pulse Rate (PR) Condition
Range
Population
ARMS
No Motion [4]
25 bpm to 240 bpm
Adults, Pediatrics
3 bpm
Motion [4]
25 bpm to 240 bpm
Adults, Pediatrics
5 bpm
Low perfusion [4]
25 bpm to 240 bpm
Adults, Pediatrics
3 bpm
Display Ranges Parameter
Display Ranges
SpO2 (Oxygen Saturation)
0% to 100%
PR (Pulse Rate)
25 bpm to 240 bpm
PI (Perfusion Index)
0.02% to 20%
Pleth Variability Index (PVI)
0% to 100%
The emitted wavelengths range from 600 nm to 1000 nm and the peak optical power is less than 15 mW. Information about the wavelength range can be especially useful to clinicians.
SpO2 Performance Specifications Table below provides ARMS (Accuracy Root Mean Square) values measured using the MightySat Rx with Masimo SET Oximetry Technology in a clinical study under no motion conditions. The below Bland-Altman plot represents the correlation of the (SpO2 + SaO2)/2 versus (SpO2 - SaO2) under no motion with an upper 95% and lower 95% limits of agreement. Measured ARMS Values Range
(ARMS)
90% – 100%
1.08%
80% – 90%
1.95%
70% – 80%
1.79%
Overall Claimed Accuracy Value Range
(ARMS)
70% – 100%
2%
37694/8721A-0215
Battery Life
Symbols
Item
Description
The following symbols may be found on the product or packaging.
Operating
1.5 Volt AAA Battery
Symbol
Battery Life
*Approximately 1800 spot checks
Definition
Symbol
Follow Instructions for Use
Definition Protection from ingress of particulates > than 12.5 mm and ingress from spraying water
IP23
*Note: Based upon 15 hours of operation with screen brightness set to 50% a spot check of 30 seconds.
Physical Characteristics Item
Description
Dimensions
2.9” x 1.6 ” x 1.2” (7.4 cm x 4.1 cm x 3.0 cm)
Weight without Battery
0.11 lbs. (51g)
Weight with Battery*
0.16 lbs. (73g)
*Note: Weight is dependent on batteries used
Consult Instructions for Use
ETL Intertek certification. Conforms to ANSI/AAMI ES 60601-1 and certified to CAN/CSA STD C22.2 No. 60601-1
Manufacturer
Mark of Conformity to European Medical Device Directive 93/42/EEC
Date of Manufacture
Wireless features can be used in member states with the restriction of indoor use in France
Not for Continuous Monitoring (No Alarm for SpO2)
Not made with natural rubber latex
Type BF Applied Part
Polypropylene
Separate collection for electrical and electronic equipment (WEEE)
Storage/transport temperature and air pressure range
Bluetooth LE Wireless Technology Information Bluetooth Wireless Technology Information Modulation Type
GFSK
Max. Output Power
-1 dBm
Frequency Range
2402 MHz - 2480 MHz
Antenna Peak Gain
-7 dBi
Recommended Range
~10 feet (~3 meters) line-of-sight
FCC ID, IC, IC Model
Non-Sterile
Identifies unit has been registered as a radio device
Federal Communications Commission (FCC) licensing
Radio Compliance Radio Modes
Bluetooth LE
USA
FCC ID: VKF-MSAT01A FCC parts 15.207 and 15.247
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Canada
IC-7362A-MSAT01A RSS-210
Guidance and Manufacturer's Declarations - Electromagnetic Emissions
Europe
EN 300 328
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.
EN 301 489-17
Emission Test
Environment
RF Emissions CISPR 11
Item
Description
Operating Temperature Range
5°C to 40°C
Operating Humidity
10% to 95% RH
Storage/Transport Temperature
-40°C to 70°C
Atmospheric pressure
540 mBar to 1060 mBar
RF Emissions CISPR 11
Compliance
Electromagnetic Environment - Guidance
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.
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
Compliance
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.
Safety Compliance ANSI/AAMI 60601-1 CSA C22.2 No. 60601-1 IEC 60601-1
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment - Guidance
Electrostatic discharge (ESD)
+6 kV contact
+6 kV contact
+8 kV air
+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%.
3 A/m
3 A/m
IEC 61000-4-2
EN 60601-1
Power frequency (50 / 60 Hz) magnetic field.
IEC 60601-1-6 IEC 60601-1-11
Power frequency magnetic fields should be at levels characteristic of typical location in a typical hospital environment.
IEC 61000-4-3
ISO 80601-2-61
Recommended separation distance EMC Compliance IEC 60601-1-2, Class B Radiated RF
ISO 80601-2-61: Clause 202, 20 V/m radiated immunity
IEC 61000-4-3
20 V/m 80 MHz to 2.5 GHz
20 V/m
80 MHz to 800 MHz
ISO 80601-2-61, Clause 202
Equipment Classifications per IEC 60601-1 Degree of Protection against electric shock
Type BF applied part
Mode of Operation
Continuous
Degree of Protection from Liquid Ingress
IP23, Protection from ingress of particulates > than 12.5 mm and ingress from spraying water.
Environment
Not for use in the presence of flammable anesthetics
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 (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic b site survey, should be less than the compliance level in each frequency range . 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.
Citations
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1.
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.
2.
3.
4.
The Masimo SET Technology used in the MightySat Rx Fingertip Pulse Oximeter has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70%-100% SpO2 against a laboratory co-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The Masimo SET Technology used in the MightySat Rx Fingertip Pulse Oximeter has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70%-100% SpO2 against a laboratory co-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The Masimo SET Technology used in the MightySat Rx Fingertip Pulse Oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The Masimo SET Technology used in the MightySat Rx Fingertip Pulse Oximeter has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.This variation equals plus or minus one standard deviation which encompasses 68% of the population.
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
80 MHz to 800 MHz
d = 1.17*Sqrt (P)
d = 0.18*Sqrt (P)
800 MHz to 2.5GHz d = 0.35*Sqrt (P)
0.01
0.12
0.018
0.035
0.1
0.37
0.057
0.11
1
1.17
0.18
0.35
10
3.7
0.57
1.1
100
11.7
1.8
3.5
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.
MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK,FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH 3148433
ANSI/AAMI ES 60601-1:2005,CAN/CSA C22.2 No. 60601-1:2008, and applicable Particular, (ISO 80601-2-61:2011) and related Collateral (IEC 60601-1-11:2010) Standards for which the product has been found to comply by Intertek.
© 2015 Masimo Corporation Patents: www.masimo.com/patents.htm. Masimo, Signal Extraction Technology, SET, and Signal I.Q. are federally registered trademarks of Masimo Corporation. MightySat is a trademark of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners.
37694/8721A-0215