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Summary of Contents for Masimo iSpO2
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Page 3: Table Of Contents
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... - Page 4 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...
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Page 5: 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. -
Page 6: Product Description
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. -
Page 7: Safety Information, Warnings, And Cautions
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. - Page 8 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.
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Page 9: Intended Use
(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. -
Page 10: Accessing The Ispo2 App
Accessing the iSpO2 App To access the iSpO2 App Before using the iSpO2 for the first time, download the iSpO2 app from the Google Play Store. 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. -
Page 11: Using Ispo2
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. - Page 12 Masimo...
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Page 13: About Ispo2 Screens
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. -
Page 14: Signal I.q.® Indicators
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. www.masimo.com Masimo... -
Page 15: About The Trend Feature
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. www.masimo.com Masimo... -
Page 16: Options Screen
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. -
Page 17: Best Practices For Accurate Readings
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. - Page 18 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. www.masimo.com Masimo...
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Page 21: Screen Messages
Screen Messages Message Potential Resolution Ensure cable is connected Make sure the iSpO2 is securely connected. See Contacting Tech Support on page 18. Sensor not working Place sensor on properly See Best Practices for Accurate Readings on page 13. Searching for pulse (for > 30 seconds) See Best Practices for Accurate Readings on page 13. -
Page 22: Contacting Tech Support
Contacting Tech Support If there is an issue and assistance is needed, call 1-877-964-8378 or e-mail TechSupport-US@Masimo.com with the following information: • Name • Phone number and e-mail address • Problem description • iSpO2 serial number (found on the back of the iSpO2 cable) •... -
Page 23: Technical Information
Android-powered device. Disinfecting the iSpO2 Remove the sensor from your finger and disconnect the iSpO2 module from the Android-powered device. Clean the sensor, cable and connector by wiping with a 70% isopropyl alcohol pad. Allow the iSpO2 module to dry thoroughly prior to placement on your finger. -
Page 24: Disinfecting The Mobile Device
Avoid getting the disinfectant inside the dock connector or port. After wiping, allow the device to air dry. If the cleaned area of the device becomes dry before the recommended drying time (2 minutes), re-wipe. Refer to the disinfectant wipe's packaging for hand-cleaning and wipe disposal instructions. www.masimo.com Masimo... -
Page 25: Specifications
Specifications Measurement Display Ranges SpO2 (Blood Oxygenation) 0% to 100% PR (Pulse Rate) 25 bpm to 240 bpm PI (Perfusion Index) 0.02% to 20% www.masimo.com Masimo... -
Page 26: Accuracy
Under no motion conditions, is ± 3 bpm Under motion conditions, is ± 5 bpm The emitted wavelengths range from 600 to 1000 nm and the peak optical power is less than 15 mW. For more information and updates about iSpO2, visit www.ispo2.com. www.masimo.com Masimo... -
Page 27: Citations
This variation equals plus or minus one standard deviation which encompasses 68% of the population. The Masimo SET Technology used in the iSpO2 module has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population. -
Page 28: Symbols
Symbols The following symbols may be found on the product or packaging. Symbol Definition See Instructions for Use Follow Instructions for Use Manufacturer Date of Manufacture Do not use if package is damaged or opened www.masimo.com Masimo... - Page 29 Not for Continuous Monitoring (No Alarm for SpO2) Protection against liquid drops falling vertically Conforms to UL STD 60601-1 and certified to CAN/CSA STD C22.2 No. 601.1 Mark of Conformity to European Medical Device Directive 93/42/EEC WEEE Compliant www.masimo.com Masimo...
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Page 31: Contacting Masimo
Fax:+1 949 297 7001 Warranty 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. -
Page 32: Sales & End-User License Agreement
Products or Software. In no event shall Masimo’s 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. - Page 33 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.
- Page 34 Patents: www.Masimo.com/patents.htm Masimo, , iSpO2, SET and Signal I.Q. are federally registered trademarks of Masimo Corporation. The Android robot is reproduced or modified from work created and shared by Google and used according to terms described in the Creative Commons 3.0 Attribution License.
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