Masimo iSpO2 User manual

Contents
Introducing iSpO2® ---------------------------------------------------------------------------------------------------- 1
Product Description------------------------------------------------------------------------------------------------- 2
About this Manual --------------------------------------------------------------------------------------------------2
Safety Information, Warnings, and Cautions------------------------------------------------------------------------3
Intended Use-------------------------------------------------------------------------------------------------------------5
Compatibility --------------------------------------------------------------------------------------------------------5
Accessing the iSpO2 App-----------------------------------------------------------------------------------------------6
Using iSpO2-------------------------------------------------------------------------------------------------------------- 7
About iSpO2 Screens ---------------------------------------------------------------------------------------------------9
Main Screen----------------------------------------------------------------------------------------------------------9
Signal I.Q.® Indicators------------------------------------------------------------------------------------------- 10
History Screen ----------------------------------------------------------------------------------------------------- 10
About the Trend Feature ------------------------------------------------------------------------------------------11
Options Screen -----------------------------------------------------------------------------------------------------12
Best Practices for Accurate Readings -------------------------------------------------------------------------- 13
Screen Messages -------------------------------------------------------------------------------------------------------17
Contacting Tech Support ---------------------------------------------------------------------------------------- 18
Technical Information------------------------------------------------------------------------------------------------ 19

Cleaning------------------------------------------------------------------------------------------------------------- 19
Disinfecting the Mobile Device----------------------------------------------------------------------------------20
Specifications ------------------------------------------------------------------------------------------------------ 21
Accuracy------------------------------------------------------------------------------------------------------------- 22
Citations ------------------------------------------------------------------------------------------------------------23
Symbols ------------------------------------------------------------------------------------------------------------- 24
Contacting Masimo---------------------------------------------------------------------------------------------------- 27
Warranty ------------------------------------------------------------------------------------------------------------ 27
Exclusions----------------------------------------------------------------------------------------------------------- 27
Sales & End-User License Agreement --------------------------------------------------------------------------28
Restrictions---------------------------------------------------------------------------------------------------------28

Introducing iSpO2®
Not Intended for Medical Use
The Masimo Difference
For more than 20 years, Masimo has been focused on a singular mission – to take non-invasive monitoring to new
sites and applications. Visit www.Masimo.com to learn why clinicians worldwide know and trust Masimo.
From the leaders in hospital pulse oximetry comes the world’s first pulse oximeter for select Android™-powered
devices that measures during movement and low blood flow to the finger. The iSpO2® is for noninvasive monitoring,
tracking and trending of blood oxygenation (SpO2), pulse rate, and perfusion index for sports and aviation use.
For information, updates and manuals in available languages for iSpO2 visit www.ispo2.com.

Product Description
•The iSpO2 system includes the following:
•Sensor (with cable)
There are two iSpO2 sizes:
•Small if you have slender fingers and/or weigh under 110 lbs. (50 kg).
•Large if you weigh more than 66 lbs. (more than 30 kg).
•App
The Masimo iSpO2 app may be downloaded from the Google Play™ Store.
About this Manual
This manual explains how to set up and use the iSpO2. Important safety information relating to general use of the
iSpO2 module appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this
manual. The following are explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death)
to the user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the user to avoid injury to the user, 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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Safety Information, Warnings, and Cautions
The manual including all precautionary information, and specifications should be read before use.
Always use the iSpO2 precisely in accordance with the directions in this manual, including finger selection and
finger alignment in the sensor. See Best Practices for Accurate Readings on page 13.Failure to follow all of the
directions in this manual could lead to inaccurate measurements.
WARNING: To avoid the risk of electrical shock, when using the iSpO2 do not plug anything else into any port of the
Android-powered device, including a headphone jack or docking port.
WARNING: To avoid the risk of electrical shock, do not use the iSpO2 when the Android-powered device is plugged
into an AC power outlet.
WARNING: Carefully route cabling to reduce the possibility of your entanglement or strangulation.
WARNING: Do not adjust, repair, open, disassemble, or modify this unit. Injury or equipment damage could occur.
Return unit for servicing.
WARNING: Inaccurate SpO2 readings may be caused by:
•Intravascular dyes such as indocyanine green or methylene blue
•Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
•Elevated levels of bilirubin
•Severe anemia
•Low arterial perfusion
•motion artifact
CAUTION: Do not use a sensor or cable with exposed optical or electrical components.
CAUTION: Do not use damaged sensors or cables.
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CAUTION: Do not autoclave or submerge the equipment in any cleaning solution. This will seriously damage the
unit.
CAUTION: High-intensity extreme lights (including pulsating strobe lights and direct sunlight) directed on the
sensor, may not allow the iSpO2 to obtain readings.
CAUTION: Do not attempt to reprocess, recondition or recycle any Masimo sensors or cables as these processes may
damage the electrical components, potentially leading to user harm.
CAUTION: Failure to apply the sensor properly may lead to incorrect measurements.
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Intended Use
The iSpO2 by Masimo is for use by sports and aviation users who are interested in knowing their blood oxygenation
level (SpO2), pulse rate (PR) and perfusion index (PI). The results will display on an Android-powered device. The
iSpO2 is not intended for medical use. The iSpO2 can be used in a wide range of settings, including extreme sports,
and for passengers and pilots.
Compatibility
For select Android-powered devices.
See the product's box label or visit www.iSpO2.com for device compatibility.
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Accessing the iSpO2 App
To access the iSpO2 App
1. Before using the iSpO2 for the first time, download the iSpO2 app from the Google Play Store.
2. Install the app on the Android-powered device. See Compatibility on page 5.
If the app does not recognize iSpO2 module as an accessory, remove and reconnect the module. See
Contacting Tech Support on page 18.
3. When prompted to connect the app with the iSpO2 module, select Allow.
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Using iSpO2
Before you begin, see Safety Information, Warnings, and Cautions on page 3.
1. Insert the iSpO2 connector into the dock connector port of the Android-powered
device.
To avoid electrical shock, do not use the iSpO2 when the Android-powered
device is plugged into an AC power outlet.
To avoid electrical shock when using the iSpO2, do not plug anything else
into any port of the Android-powered device, including a headphone jack or
docking port.
2. Select a finger for monitoring. See Best Practices for Accurate Readings on page
13.
3. Place your finger in the iSpO2.
The measurements will display on the Android-powered device as a waveform measurement
and numeric display.
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About iSpO2 Screens
Main Screen
SpO2 (Oxygen Saturation)
Displays functional oxygen saturation of arterial hemoglobin
PR (Pulse Rate)
Displays PR as beats per minute (BPM)
PI (Perfusion Index)
Displays arterial pulse signal strength (Perfusion Index)
Waveform
Displays arterial pulsations as a waveform.
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Signal I.Q.® Indicators
The Signal I.Q.® (SIQ) provides an indicator of the assessment of the confidence in the displayed SpO2 value. The
height of the vertical line of the SpO2 SIQ provides an assessment of the confidence in the measurement displayed.
A high vertical line indicates higher confidence in the measurement. A small vertical line indicates lower confidence
in the displayed measurement.
SIQ Indicators with high vertical lines
History Screen
The History screen allows you to access customizable Trend views. Press History on the screen to see detailed
information.
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About the Trend Feature
Expand and contract trend views
You can expand or contract the trend data display by using a pinch
gesture with two fingers.
Trend time views
Three separate times are shown at the bottom of the screen. Visible
from the left, they are: the beginning time of the trend, the
midpoint (stationary white line highlighted shown), and the time of
the last data point within the trend. You can view trend data and
increase or decrease the amount of trending time by swiping the
display to the left or to the right.
Track and email trend data
The Trend feature shows several readings. You can track the data,
email it and then display it in any .csv file spreadsheet program.
See Options Screen on page 12.
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Options Screen
Sound
To turn on or turn off, slide the Sound button.
E-Mail CSV
Measurement trend history can be compiled into a .csv file and emailed.To email trend history, touch E-Mail CSV,
and enter desired email address. The e-mail can be saved as a draft, deleted, or sent. All stored trend history will be
sent in one e-mail.
Auto-Remove Old Data
The iSpO2 can store up to 12 (twelve) hours of oxygen saturation (SpO2) and pulse rate (PR) data. Select the amount
of measurement history to store in the device (between 1 and 12 hours). Any data beyond this range will overwrite
previously recorded measurements. For instance, if you record one hour of measurement data and then go beyond
the one hour, the new data beyond the 1 hour mark will overwrite a portion of the previously recorded data. A 12 hour
setting is recommended unless the device memory is full. Clear existing measurement history at any time by
pressing "Clear All History".
Clear History
Stored measurement history and trend data can be deleted. To delete all stored data, touch Clear All History.
Module Info
The information here may be helpful for troubleshooting.
About
A general definition of Pulse Oximetry and a description of theiSpO2 measurements.
Support
Website links, and contact information for support and customer service.
Tutorial
A graphic explanation on how to use theiSpO2.
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Best Practices for Accurate Readings
•Ensure that your finger and the sensor are aligned (i.e. the iSpO2 is parallel to the finger). Ensure that
the iSpO2 cable is not twisted, as that can cause incorrect alignment.
•Ensure that your finger is inserted correctly and completely into the iSpO2. The tip of your finger should
be touching the soft rubber stop inside the sensor.
•Select your testing finger, in the following priority:
1. Non-dominant ring finger (non-dominant is the hand used less often).
2. Non-dominant middle finger
3. Dominant ring finger (dominant is the hand used more often).
4. Dominant middle finger
•Do not use on an anatomically incorrect finger (e.g. damaged, clubbed, deviated, etc.).
•If artificial nails or excessive fingernail polish are present, select another site or remove the
polish/artificial nails.
•Do not use on a finger with occlusive jewelry, such as a ring.
•Your finger should be cleaned of debris and dry prior to sensor placement.
•Do not expose the iSpO2 to moisture, humid environments or liquids.
•If possible, ensure that the iSpO2 is placed in a location with low ambient light. Excessive ambient light
may cause readings to be incorrect.
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•Check for possible EMI radiation interference such as computer displays and/or LCD/plasma TVs.
•Failure to apply the sensor properly may lead to incorrect measurements.
•The iSpO2 has no alarms and is not designed for continuous monitoring. It should be removed and
repositioned after each session.
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