Masimo iSpO2 Operator'S Manual Download Page 3

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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

Summary of Contents for iSpO2

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Page 3: ...ns 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 ...

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 ...

Page 5: ...orldwide 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 av...

Page 6: ...s 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...

Page 7: ... 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 ...

Page 8: ...be 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 www masimo com 4 Masimo ...

Page 9: ...sion 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 www masimo com 5 Masimo ...

Page 10: ...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 www masimo com 6 Masimo ...

Page 11: ...vice 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 measurem...

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Page 13: ...splays 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 www masimo com 9 Masimo ...

Page 14: ...nt 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 www masimo com 10 Masimo ...

Page 15: ...ing 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 spreadsh...

Page 16: ...corded 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 ...

Page 17: ...ten 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 b...

Page 18: ...puter 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 14 Masimo ...

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Page 21: ... seconds See Best Practices for Accurate Readings on page 13 Interference detected see manual See Best Practices for Accurate Readings on page 13 Low perfusion see manual See Best Practices for Accurate Readings on page 13 Too much surrounding light Move to a location with normal or low light Low signal quality see manual See Best Practices for Accurate Readings on page 13 Connecting Please wait S...

Page 22: ...64 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 Software revision See Options Screen on page 12 Best time to call back www masimo com 18 Masimo ...

Page 23: ... the iSpO2 module to dry thoroughly prior to placement on your finger or 1 If low level disinfection is required use a 1 10 bleach water solution 2 Saturate a cloth or gauze pad with the cleaning solution and wipe all surfaces of the sensor cable and connector 3 Saturate another cloth or gauze pad with sterile or distilled water and wipe all surfaces of the sensor cable and connector 4 Dry with a ...

Page 24: ...s 1 Pre clean the outside of the device with a disinfecting wipe 2 With a new disinfecting wipe disinfect the Android powered device following the instructions below Additionally follow the instructions on the disinfecting wipe packaging for safe handling of the wipes 3 Wipe each side of the Android powered device with moderate pressure three 3 times using the following method 1 Wipe up and down t...

Page 25: ...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 21 Masimo ...

Page 26: ...perfusion conditions 3 is 2 Pulse rate accuracy4 in the range of 25 240 range 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 22 Masimo ...

Page 27: ...nduced 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 3 The Masimo SET Technology used in the iSpO2 module 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...

Page 28: ...g 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 24 Masimo ...

Page 29: ...g 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 25 Masimo ...

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Page 31: ...duct that it deems to be covered under warranty with a replacement iSpO2 Pulse Oximeter Exclusions 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 Masimo s written authorization b supplies instruments or electrical work external to the Product or not manufactured by Masimo c disa...

Page 32: ...ability 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 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...

Page 33: ...n consent except that the Software and all of Purchaser s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included Any attempt to assign any rights duties or obligations arising hereunder other than as set forth in this paragraph shall be void 4 U S Government Rights If Purchaser is acquiring Software including the r...

Page 34: ... or modified from work created and shared by Google and used according to terms described in the Creative Commons 3 0 Attribution License Android Google Google Play and other marks are trademarks of Google Inc 2013 All rights reserved All trademarks and or copyrights are properties of their respective owners 2013 Masmo Corporation www masimo com 30 Masimo ...

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Page 36: ...www masimo com 36575 LAB 7908A 0913 ...

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