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UMD-0001 REV D

DEVICE PERFORMANCE, CONT.

Oxygen saturation Bland-Altman plot from induced

hypoxia study with human subjects

100

-10

-8

-6

-4

-2

)

(SpO2+SaO2)/2 (%)

Linear
regression

Upper 95%
agreement

Lower 95%
agreement

Содержание Oxxiom

Страница 1: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D oxxiom Wireless Disposable Single Use Pulse Oximetry System Made in USA User Guide Requires Oxxiom Rx App for iOS devices...

Страница 2: ...nd the products described herein at any time without notice or obligation True Wearables Oxxiom and the True Wearables logo are registered trademarks of True Wearables Inc The other trademarks mention...

Страница 3: ...STEM SYMBOLS IN THE OXXIOM RX APP GUIDED ACCESS MODE OXXIOM WARNING SYSTEM MORE INFORMATION ON OXXIOM RX APP CARE AND MAINTENANCE TROUBLESHOOTING DEVICE PERFORMANCE OXXIOM DEVICE TECHNICAL SPECIFICATI...

Страница 4: ...splaying and storing functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate PR It may be used for spot checking intermittent monitoring and or data collection of patients 12 years and...

Страница 5: ...sive atmosphere 3 Do not use Oxxiom in the presence of flammable anesthetics or gases 4 Oxxiom is intended for single use only Do not gas sterilize or autoclave Oxxiom Do not expose or immerse Oxxiom...

Страница 6: ...ion with other methods of assessing clinical signs and symptoms 3 Do not modify Oxxiom in any way Maintenance is not required 4 The operation of this device may be affected when near an electrosurgica...

Страница 7: ...perly Batteries can leak or explode if used or disposed of improperly Follow local ordinances for disposal 9 Battery life may be significantly shortened by being in stand by mode for an extended amoun...

Страница 8: ...d other interference sources in the environment of operation high interference levels might occur and disrupt the operation of this device 2 If Oxxiom appears damaged or if Oxxiom fails to respond as...

Страница 9: ...the extremity to increase circulation 7 Finger deformities and calluses may cause inaccurate readings 8 Inspect the measurement site at least every 8 hours to ensure correct device placement following...

Страница 10: ...True Wearables Inc UMD 0001 REV D 10 9 Excessive pressure to the measurement site may damage tissue or make measurements inaccurate 10 Some patients skin may be sensitive to the Oxxiom tape and or ad...

Страница 11: ...the Oxxiom device hardware device and the Oxxiom Rx App Oxxiom does not have a dedicated display or alarm system It requires a handheld iOS device for use The iOS device can be an iPhone iPad or iPod...

Страница 12: ...are applied to the measurement site by the light emitter The red and infrared light rays penetrate the blood perfused dermis and interact with the heart s pulsatile signal in order to create red and i...

Страница 13: ...lude the following Wireless measurement of oxygen saturation of arterial hemoglobin SpO2 pulse rate PR and pulse amplitude PA Warnings visual and audible Voice based measurements for SpO2 PR and PA ev...

Страница 14: ...f heartbeats per minute Pulse Amplitude PA is the normalized peak to peak amplitude of the pulsatile signals plethysmographs generated at the measurement site by the heart activity and detected by an...

Страница 15: ...supine position Higher perfusion in warm environment Strong vasoconstrictor response to cold Skin callouses and deformities may cause false readings Proper pressure from tape wrapped around finger is...

Страница 16: ...hree items 1 Oxxiom device 2 Self adhering breathable gentle tape for application to finger 3 Label with 2 dimensional UDI and QR barcodes In addition to the three items from the package the Oxxiom Pu...

Страница 17: ...True Wearables Inc UMD 0001 REV D 17 PACKAGE LAYOUT AND CONTENTS CONT Blister pack Anti tamper tab Front view Back view Isometric view Oxxiom device Self adhering breathable gentle tape roll Blister...

Страница 18: ...t App Store ii Search for Oxxiom Rx in the App Store iii Select Oxxiom Rx to download App The Oxxiom Rx App will be now available in your iOS device USING THE OXXIOM PULSE OXIMETRY SYSTEM Download the...

Страница 19: ...tab You may also use scissors to cut off tab USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT Open the blister pack containing the device and self adhering tape for finger application Keep the blister pack...

Страница 20: ...e Wearables Inc UMD 0001 REV D 20 Pull out Oxxiom and self adhering breathable gentle tape roll from blister pack Save label with barcodes for later use USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT Fro...

Страница 21: ...ndicates Oxxiom is activated It blinks once every 10 seconds Oxxiom is ready for placement on measurement site i e finger Pull tab 2 USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT Activate the Oxxiom dev...

Страница 22: ...p with green light facing down Take 6 8 inches of self adhering tape from the roll provided and wrap it around fingertip and Oxxiom Aim for a comfortable snug fit USING THE OXXIOM PULSE OXIMETRY SYSTE...

Страница 23: ...tooth USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT Activate Bluetooth capability on iOS Device Make sure the iOS device s battery is properly charged before use Internet access is not required for oper...

Страница 24: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D 24 Turn on Bluetooth USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT...

Страница 25: ...earables 2016 2020 True Wearables Inc UMD 0001 REV D 25 Start the Oxxiom Rx App The Oxxiom Rx App launch screen will be briefly displayed USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT Start the Oxxiom R...

Страница 26: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D 26 Select the Scan button Select Dismiss USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT Scan QR barcode on blister pack label...

Страница 27: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D 27 Select OK Scan QR barcode USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT...

Страница 28: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D 28 Visual and audible warnings will be active until Oxxiom connects to iOS device Select Done USING THE OXXIOM PULSE OXIMETRY SYSTEM CONT...

Страница 29: ...on as Oxxiom connects with iOS device waveforms are displayed Visual and audible warnings will be active until measurements are displayed After approximately 15 seconds SpO2 PR and PA measurements are...

Страница 30: ...ice has a red light it is on and connected to the iOS device operation mode Oxxiom is ready for placement on measurement site Oxxiom is connected to the iOS device USING THE OXXIOM PULSE OXIMETRY SYST...

Страница 31: ...e Wearables Inc UMD 0001 REV D 31 Description Symbol Side Drawer menu Start screen Settings screen Share Data screen About Oxxiom screen Visual warning Oxxiom s battery Audible warning Oxxiom Rx App S...

Страница 32: ...es 2016 2020 True Wearables Inc UMD 0001 REV D 32 Description Symbol Audible warnings active Audible warnings disabled SYMBOLS IN THE OXXIOM RX APP CONT Audible warning status is shown with the follow...

Страница 33: ...ription Symbol Oxxiom s battery full Oxxiom s battery 3 4 full Oxxiom s battery 1 2 full Oxxiom s battery 1 4 full Oxxiom s battery low blinking red bar Oxxiom s battery empty SYMBOLS IN THE OXXIOM RX...

Страница 34: ...are available Use Guided Access Mode to turn the iOS device into a dedicated display monitor During Guided Access Mode some Oxxiom Rx App features are disabled including termination Side Drawer menu...

Страница 35: ...ue Wearables Inc UMD 0001 REV D 35 Steps to set up Guided Access Mode on an iOS device GUIDED ACCESS MODE CONT Tap Settings General Accessibility Guided Access to set up Guided Access Turn Guided Acce...

Страница 36: ...rue wearables 2016 2020 True Wearables Inc UMD 0001 REV D 36 GUIDED ACCESS MODE CONT Set a passcode that controls the use of Guided Access and prevents unauthorized users from leaving an active sessio...

Страница 37: ...S device a session can begin Ensure the Oxxiom Rx App is active and connected to the Oxxiom device before starting a Guided Access Mode session Triple click the Home button and then tap Start Make sur...

Страница 38: ...UMD 0001 REV D 38 To end a Guided Access session on an iOS device first triple click the Home button enter the Guided Access passcode and then tap End GUIDED ACCESS MODE CONT Tap End Triple click the...

Страница 39: ...nings will issue continuously in these situations Battery in the Oxxiom device is empty Battery in iOS device is low Wireless connection between Oxxiom device and iOS device is not reliable System is...

Страница 40: ...ave crossed either upper or lower limits SpO2 and PR warnings SpO2 and PR gauges blink in red Beep Voice message Saturation and Pulse Rate warnings SpO2 measurement has crossed either upper or lower l...

Страница 41: ...o iOS device Oxxiom not connected Dashed gauges blinking in red Beep Voice message Oxxiom not connected Oxxiom s battery is empty Battery empty Gauges blink in red dashed or not Beep Voice message Oxx...

Страница 42: ...t Warning description Visual warning Audible warning Oxxiom wireless connection with iOS device is not reliable Poor connection All gauges blink in red Beep Voice message Poor connection iOS device s...

Страница 43: ...ed either upper or lower limits Has PR measurement crossed either upper or lower limits Have SpO2 and PR measurements crossed either upper or lower limits Is iOS device s battery low Generate warnings...

Страница 44: ...Factory default Oxxiom is not connected to iOS device Not adjustable Not applicable Enabled Oxxiom s battery is empty Not adjustable Not applicable Enabled Oxxiom is searching for a valid signal Not...

Страница 45: ...limits Upper limit range 85 to 100 Lower limit range 50 to 95 1 Enabled Upper limit setting 100 Lower limit setting 89 PR measurement has crossed either upper or lower limits Upper limit range 75 bpm...

Страница 46: ...ce is not reliable 1 2 3 SpO2 and PR measurements have crossed either upper or lower limits 8 12 12 21 15 30 SpO2 measurement has crossed either upper or lower limits 8 12 12 21 15 30 PR measurement h...

Страница 47: ...or a period of time silence period In order to start a silence period the user should tap any one of the linear measurement gauges bars The silence period can be set by the user in the Settings menu S...

Страница 48: ...arables Inc UMD 0001 REV D 48 Activating silence period Bell with slash indicates audible warnings are disabled Select silence period in Settings Tap any linear measurement gauge to activate silence P...

Страница 49: ...s user to enable or disable audible warnings measurements via a toggle switch in Settings The user can set the audible warning measurement volume via the iOS device s hardware buttons i e volume Use t...

Страница 50: ...le warnings from being disabled the iOS device Guided Access Mode MUST be enabled and used Follow the steps below to prevent disabling of audible warnings Start and connect the Oxxiom Rx App to Oxxiom...

Страница 51: ...uge displays numerical value for PR and blue bar in proportion to value 25 250 bpm 3 PA gauge displays numerical value for PA and blue bar in proportion to value 0 20 4 Side Drawer menu gives access t...

Страница 52: ...6 2020 True Wearables Inc UMD 0001 REV D 52 MORE INFORMATION ON OXXIOM RX APP CONT 2 PR gauge 3 PA gauge 5 Waveform Photoplethysmograph 4 Side Drawer menu 6 Audible warning status 7 Oxxiom s battery s...

Страница 53: ...in the iOS device Control Center is disabled The following are the trend charts available in landscape mode 1 SpO2 trend chart Tap SpO2 gauge blue bar on right to display the gauge in bold and the re...

Страница 54: ...rables Inc UMD 0001 REV D 54 MORE INFORMATION ON OXXIOM RX APP CONT Gauge in bold indicates active trend Touch gauge bar to switch trends Touch gauge bar to switch trends 1 SpO2 trend chart 2 PR trend...

Страница 55: ...play a menu to access the following screens 1 Start allows user to scan the Oxxiom QR barcode to enable iOS device to connect wirelessly to Oxxiom device 2 Settings allows user to change settings of O...

Страница 56: ...0001 REV D 56 MORE INFORMATION ON OXXIOM RX APP CONT Select to display Side Drawer menu Select to access 1 Start screen Select to access 2 Settings screen Select to access 3 Share Data screen Select t...

Страница 57: ...code will scan successfully Any other barcode will produce an error After a valid QR barcode has been scanned it cannot be deleted This prevents unintentional disconnection of the iOS device and Oxxio...

Страница 58: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D 58 MORE INFORMATION ON OXXIOM RX APP CONT Select to scan QR Barcode Select to make changes effective and return to main screen...

Страница 59: ...igures how trend data is displayed and stored 2 Chart Configures memory of trend chart displayed when iOS device screen is in landscape mode Chart memory can be set to 2 5 10 30 or 60 minutes 3 Store...

Страница 60: ...time interval for muting active audible warnings Options are 30 60 90 or 120 seconds 7 Voice Gap Defines periodicity of voice based measurements Options are 30 60 120 seconds or never 8 SpO2 Warning...

Страница 61: ...ue Visual and audible warnings will issue if PR measurement is above this value Lower Defines minimum normal value Visual and audible warnings will issue if PR measurement is below this value 10 Wavef...

Страница 62: ...Default 5 Select to enable or disable audible warnings measurements Default enabled Select to make changes effective and return to main screen Select to set trend data maximum storage time Default 24...

Страница 63: ...XXIOM RX APP CONT Select to set upper and lower SpO2 warning limits Defaults 100 0 89 Select to set upper and lower PR warning limits Defaults 187 35 Select to enable or disable waveform storage for 1...

Страница 64: ...le spreadsheet format through the Oxxiom Rx App This CSV filed can be view directly by the iOS device or other spreadsheet software such as Excel Numbers etc The CSV file has 5 columns Date Time Date...

Страница 65: ...database file WaveformsDB db This data can only be shared by the user True Wearables Inc does not collect store or analyze waveform data To Share Data 1 Select one of the two types of data and then ta...

Страница 66: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D 66 MORE INFORMATION ON OXXIOM RX APP CONT Select to return to main screen Select to choose the type of data to be shared Select to share data...

Страница 67: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D 67 MORE INFORMATION ON OXXIOM RX APP CONT Progress indicator...

Страница 68: ...true wearables 2016 2020 True Wearables Inc UMD 0001 REV D 68 MORE INFORMATION ON OXXIOM RX APP CONT Select to choose sharing method AirDrop Message Mail iCloud Print etc...

Страница 69: ...umber barcode lot number expiration date model and version of both the Oxxiom device and Oxxiom Rx App The Hardware Diagnostics section provides the following parameters reported at Time Stamp 1 LED1...

Страница 70: ...initial activation 7 Usage Time Amount of time Oxxiom device has been connect to iOS device since initial activation 8 Time Stamp Date and time when hardware diagnostic parameters were reported Techn...

Страница 71: ...er Guide 3 Website Access the True Wearables website 4 Regulatory Section Contains the Oxxiom FCC ID and adopted standards for SpO2 and PR accuracy general safety and essential performance electromagn...

Страница 72: ...iPad or iPod touch 1 Press and hold the Top or Side button 2 Immediately click the Volume up button on the left side then release the buttons 3 The screenshots will be available on the iOS Photos App...

Страница 73: ...xxiom device is not functioning properly please refer to the TROUBLESHOOTING section of this User Guide or contact the manufacturer s technical support at contact truewearables com For surface cleanin...

Страница 74: ...iOS device to its charger and charge for at least one hour The iOS device should turn on 3 If the iOS device does not turn on contact the manufacturer s technical support Oxxiom device does not turn...

Страница 75: ...within the specified maximum wireless range of 10 meters 33 feet of the iOS device 4 Make sure the QR barcode has been successfully scanned 5 Terminate the Oxxiom Rx App iPhone 8 or earlier by double...

Страница 76: ...adhering tape is wrapped around both the Oxxiom device and the finger The self adhering tape can be applied removed and repositioned 3 Please note that the Oxxiom device will not work well if the skin...

Страница 77: ...ypoxia study that compared SpO2 to SaO2 Arterial Blood CO Oximetry measurements on 10 healthy adult male and female subjects ranging in pigmentation from light to dark and wearing 40 Oxxiom devices in...

Страница 78: ...ms Spec 3 5 for range of 70 100 points n 943 307 364 272 Pass Bias 0 1 0 1 0 4 0 3 Arms 3 4 1 7 3 0 4 9 Notes The range of 70 to 100 includes reference data down to 67 4 pts 70 Tested on a Population...

Страница 79: ...T 60 65 70 75 80 85 90 95 100 60 65 70 75 80 85 90 95 100 Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 Subject 6 Subject 7 Subject 8 Subject 9 Subject 10 SpO2 SaO2 Oxygen saturation scatter plot...

Страница 80: ...0001 REV D 80 DEVICE PERFORMANCE CONT Oxygen saturation Bland Altman plot from induced hypoxia study with human subjects 65 70 75 80 85 90 95 100 10 8 6 4 2 0 2 4 6 8 10 SpO2 SaO2 SpO2 SaO2 2 Linear r...

Страница 81: ...System was evaluated with an electronic pulse simulator and during induced hypoxia study on 10 healthy adult male and female subjects The PR accuracy for the Oxxiom Pulse Oximetry System was calculat...

Страница 82: ...ompared with 4 different reference pulse oximetry systems largest Arms reported Tested on a Population of 10 adult subjects and 40 Oxxiom devices 4 Oxxiom devices per subject Subjects with normal perf...

Страница 83: ...t1 2 General Requirements for basic safety and essential performance Collateral Standard Electromagnetic Compatibility Requirements and Tests ANSI AAMI ES 60601 1 2005 R 2012 Medical electrical equipm...

Страница 84: ...ADA ICES 003 ISSUE 6 JAN 2016 CLASS B Wireless compliance with the FCC Rules for Class B Devices IEC 61000 4 3 2006 A2 2010 EN 61000 4 3 2006 A2 2010 Wireless coexistence Radiated Electromagnetic Fiel...

Страница 85: ...s Range 1 33 ft 10 m Battery Life 2 24 h SpO2 Accuracy 3 70 to 100 3 5 PR Accuracy 4 25 to 250 bpm 3 bpm Safety Standards 5 ANSI AAMI ES 60601 1 IEC 60601 1 2 2014 FCC ID 6 7 2ALHN282203 Wireless Prot...

Страница 86: ...Range 490 1000 nm Ingress Protection IPX1 Dripping water Operating Temperature 5 40 41 104 Operating Humidity 95 RH max at 40 104 Operating Altitude Up to 3 012 m 9 882 ft Storage Temperature 15 30 59...

Страница 87: ...and device stand by operation time affect battery life Tests conducted in laboratory conditions have shown that the battery life may be significantly shortened depending on the aforementioned changes...

Страница 88: ...etry guidelines of ISO 80601 2 61 2011 applicable sections Please refer to DEVICE PERFORMANCE section in this guide for a detailed description regarding Oxxiom s PR accuracy evaluation 5 The Oxxiom Pu...

Страница 89: ...System Notes Wireless continuous fully disposable single use pulse oximeter Date of Grant 04 07 2017 Frequency range 2402 2480 MHz Output power 1 mW conducted 7 Complies with FCC PART 15 SUBPART C IC...

Страница 90: ...PR and PA Waveform Chart Near infrared photoplethysmograph SpO2 PR and PA Voice Based Measurements Once every 30 60 or 120 seconds or never SpO2 Display Range 1 100 PR Display Range 25 250 bpm PA Disp...

Страница 91: ...nnected Oxxiom s battery is empty searching signal poor wireless connection iOS device s battery is low Warning Silence 30 60 90 or 120 seconds Waveform Storage 12 hours Data Sharing SpO2 PR and PA tr...

Страница 92: ...r to calculate SpO2 PR and PA measurements These algorithms produce an effective data processing time delay that is less than or equal to 12 seconds Motion in the measurement site and or interferences...

Страница 93: ...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 int...

Страница 94: ...the patient Measurement waveform data can only be shared by the user Any data sharing transaction with third parties through the Oxxiom Rx App must be started by the user The user is not required to...

Страница 95: ...ed the Oxxiom Rx App from the Apple App Store and the email App service is available and functional 1 Go to About Oxxiom screen Technical Support section 2 Select Contact Us and an email message is pr...

Страница 96: ...s Symbols to be used with medical device labels labelling and information to be supplied Serial number Indicates the manufacturer s serial number so that a specific medical device can be identified IS...

Страница 97: ...ult the instructions for use ISO 15223 1 Clause 5 1 1 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Manufacturer This symbol shall be accompani...

Страница 98: ...no presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device IEC 60417 5840 To identify a type B applied part...

Страница 99: ...ient during a single procedure IEC 60601 1 2 Clause 5 1 1 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic comp...

Страница 100: ...or important cautionary information such as warnings and precautions that cannot for a variety of reasons be presented on the medical device itself IPX1 IEC 60529 Degrees of protection provided by enc...

Страница 101: ...8 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Do not use if package is damaged Indicates a medical device that should not be used if the pack...

Страница 102: ...l rights reserved This User Guide is for the purpose of Oxxiom s operation and reference only All rights reserved No part of this User Guide may be reproduced distributed or transmitted in any form or...

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