Covidien Nellcor Series Operator'S Manual Download Page 138

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Clinical Studies

A-20

Operator’s Manual

Figure A-16.

Modified Bland-Altman for Pulse Rate - D-YSE Sensor (No Motion):

ECG HR vs. (Pulse Rate - ECG HR)

Correlation plots for all the data are presented in Figure A-17 and Figure A-18 for
SpO

and pulse rate respectively.

Pulse Rate - ECG HR (BPM)

Upper 95% LoA

ECG HR (BPM)

Mean Bias

Lower 95% LoA

Summary of Contents for Nellcor Series

Page 1: ...Operator s Manual Nellcor Bedside SpO2 Patient Monitoring System TM...

Page 2: ...IDIEN COVIDIEN with logo and Covidien logo and Positive Results for Life are U S and internationally registered trademarks of Covidien AG brands are trade marks of their respective owners Other brands...

Page 3: ...Panel and Display Components 2 3 2 4 2 Rear Panel 2 7 2 4 3 Product and Carton Label Symbols 2 8 3 Installation 3 1 Overview 3 1 3 2 Safety Reminders 3 1 3 3 Unpacking and Inspection 3 2 3 4 Power 3...

Page 4: ...4 19 4 9 Menu Structure and Factory Defaults 4 20 4 10 Maintenance Reminder 4 22 5 Data Management 5 1 Overview 5 1 5 2 Tabular Trend Data 5 1 5 3 Graphical Trend Data 5 2 5 4 External Data Communicat...

Page 5: ...l Equipment 9 4 9 4 Biocompatibility Testing 9 4 10 Theory of Operations 10 1 Overview 10 1 10 2 Theoretical Principles 10 1 10 3 Automatic Calibration 10 2 10 4 Functional versus Fractional Saturatio...

Page 6: ...ety Tests 11 14 11 9 Essential Performance 11 17 A Clinical Studies A 1 Overview A 1 A 2 Methodology A 1 A 2 1 Hypoxia Methodology Accuracy Low Saturation and Motion Studies A 1 A 2 2 Low Saturation M...

Page 7: ...romagnetic Immunity Guidelines and Compliance 11 10 Table 11 8 Recommended Separation Distance Calculations 11 11 Table 11 9 Recommended Separation Distances 11 12 Table 11 10 Test Specifications for...

Page 8: ...Page Left Intentionally Blank vi...

Page 9: ...leep Study Mode 4 16 Figure 4 17 Sleep Study Mode Main Screen 4 17 Figure 4 18 Volume Menu Item 4 18 Figure 4 19 Volume Selection 4 18 Figure 4 20 Brightness Menu Item 4 19 Figure 4 21 Brightness Sele...

Page 10: ...ied Bland Altman for Pulse Rate MAXA Sensor No Motion ECG HR vs Pulse Rate ECG HR A 14 Figure A 11 Modified Bland Altman for Pulse Rate MAXN Sensor No Motion ECG HR vs Pulse Rate ECG HR A 15 Figure A...

Page 11: ...e ECG HR A 30 Figure A 25 Modified Bland Altman for SpO2 MAXA Sensor Motion SaO2 vs SpO2 SaO2 A 31 Figure A 26 Modified Bland Altman for SpO2 MAXN Sensor Motion SaO2 vs SpO2 SaO2 A 32 Figure A 27 Modi...

Page 12: ...Page Left Intentionally Blank x...

Page 13: ...e of the Nell cor bedside SpO2 Patient monitoring system Other important safety information appears throughout the manual The Nellcor bedside SpO2 patient monitoring system will be referred to as the...

Page 14: ...efully route patient cabling to reduce the possibility of patient entanglement or strangulation WARNING Do not simultaneously touch the patient and the signal input signal output or any other connecto...

Page 15: ...ded for use in a hospital or hospital type environment by trained medical personnel WARNING Failure to cover the pulse oximetry sensor site with opaque material in high ambient light conditions may re...

Page 16: ...onitoring system If fluid spills on the monitoring system remove batteries wipe dry immediately and have it serviced to ensure no hazard exists Caution Accessory equipment connected to the monitoring...

Page 17: ...nductor in the installation or its arrangement is in doubt the monitoring system operates from its battery Caution Thismonitoringsystemgenerates uses andcanradiateradiofrequencyenergyand if not instal...

Page 18: ...s guide to home caregivers and recommend that they use it Nellcor Pulse Oximetry Sensor Directions for Use Guides sensor selection and usage Before attaching any of the various Covidien approved pulse...

Page 19: ...Covidien makes no warranty of any kind with regard to this material including but not limited to the implied warranties or merchantability and fitness for a particular purpose Covidien shall not be l...

Page 20: ...Introduction Page Left Intentionally Blank 1 8 Operator s Manual...

Page 21: ...gen saturation SpO2 Functional measure of oxygenated hemoglobin relative to the sum of oxyhemoglobin and deoxyhemoglobin Pulse rate PR Detected heart pulsations in beats per minute Plethysmographic wa...

Page 22: ...tion and motion conditions and for patients who are either well or poorly perfused in hospitals hospital type facilities intra hospital transport or home environments Note Hospital use typically cover...

Page 23: ...and re enabling the audible alarm Reference Menu Navigation p 4 4 3 Home button Press to display the OPTIONS Menu or to exit a menu dis played on the screen and go to the main screen Refer ence Menu...

Page 24: ...o the left of the dynamic SpO2 value 3 Time Indicates the current time in hours minutes and seconds 4 Pulse amplitude blip bar Indicates pulse beat and the relative non normalized pulse amplitude As t...

Page 25: ...the alarm Critically Low Battery A high priority alarm occurs for about five 5 minutes before the monitoring system shuts off The flashing red alarm message Critically Low Battery appears When no char...

Page 26: ...its are set to pediat ric limit values Neonatal mode Indicates alarm limits are set to neonate limit values Homecare mode Indicates operating mode for lay users Sleep Study mode Indicatesoperatingmode...

Page 27: ...Pulse rate value Black background General background Red background Flashing SpO2 High priority alarm condition Yellow background Alarm condition Green font Steady Informative message Yellow font Low...

Page 28: ...ure Prescription only device Keep dry Attention consult accompanying doc uments Fragile Atmospheric pressure limitations UL listed Humidity limitations CE Mark Temperature limitations Manufacturer Thi...

Page 29: ...o rain Such exposure may cause inaccurate performance or device failure Reference Product Specifications p 11 1 WARNING The monitoring system should not be used adjacent to or stacked with other equip...

Page 30: ...ualified service technician should verify the performance of the monitoring system following the procedures outlined in the Nellcor bedside SpO2 patient monitoring system Service Manual prior to initi...

Page 31: ...k of the equipment Reference Period ic Safety Checks p 7 4 To connect the AC power cable 1 Ensure the AC outlet is properly grounded and supplies the specified voltage and fre quency 100 240 VAC 50 60...

Page 32: ...ation or to recharge the internal battery The monitoring system has an internal battery that powers the monitoring system when AC power is not available The monitoring system cannot operate with a ful...

Page 33: ...stem battery status icon indicates the battery charge condition To charge the internal battery 1 Connect the monitoring system to AC power to charge a low or depleted battery Ref erence AC Power Conne...

Page 34: ...check of the equipment Reference Periodic Safety Checks p 7 4 Reference Nellcor Pulse Oximetry Sensors p 9 1 for details regarding sensor selection To fully connect a Nellcor pulse oximetry sensor 1...

Page 35: ...ator s Manual 3 7 A Sensor Message occurs when the device cannot obtain an SpO2 level or a pulse rate Note If the sensor is not connected firmly the monitoring system could lose signal from patient No...

Page 36: ...Installation Page Left Intentionally Blank 3 8 Operator s Manual...

Page 37: ...te as directed in the Directions for Use to ensure skin integrity correct positioning and adhesion WARNING Keep patients under close surveillance when monitoring It is possible although unlikely that...

Page 38: ...d alarm indicate the pulse oximetry sensor is either disconnected or has faulty wiring Check the connection and if necessary replace it the pulse oximetry cable or both 4 3 Apply Power to Monitoring S...

Page 39: ...battery power If the Low Battery alarm occurs charge the battery by plugging the monitoring system s power cord into a wall outlet 5 Ensure all monitoring screen elements are properly displayed Note...

Page 40: ...Power On Off button Press and hold this blue button to power on or to power off the monitoring system Home button Press this green button for less than two 2 seconds to display the Options Menu or to...

Page 41: ...desired patient mode Adult Pediatric or Neonatal To set patient mode 1 Select the Patient Mode icon 2 Select the correct patient mode type Adult Use for adults Pediatric Use for children Neonatal Use...

Page 42: ...ues to the left of the dynamic SpO2 value Reference Menu Structure and Factory Defaults p 4 20 for default alarm limit settings Pulse Rate PR numerical area Displays the pulse rate in beats per minute...

Page 43: ...Pulse Rate alarm limits Upper and lower pulse rate alarm limit thresholds Pulse rate alarm inhibition to disable audible alarms for pulse rate limit violations SatSeconds alarm management value Refere...

Page 44: ...screen A white outline appears around the area 2 Select the desired area then make the desired settings ALARM LIMITS Menu Note Reference Menu Structure and Factory Defaults p 4 20 for adult pediatric...

Page 45: ...nd select it to display the WAVEFORM Menu Figure 4 6 Waveform Display Area Highlighted Figure 4 7 SpO2 Waveform Menu 2 Set the Sweep Speed Sweep Speed is the speed at which the SpO2 waveform trace mov...

Page 46: ...s that require user attention the monitoring system enters an alarm state The monitoring system uses both visual and audible indicators to identify high prior ity medium priority and low priority alar...

Page 47: ...utton will silence all audible alarms except Battery Critically Low Audible alarm indicators include pitched tones and beeps Caregivers may choose to silence the audible alarm for the established Alar...

Page 48: ...ble the audio tones during the Alarm Silence period press the Silence Alarm button again To silence an audible alarm 1 Press the Silence Alarm button 2 To re enable press the Silence Alarm button agai...

Page 49: ...calculation of pulse rate nor does it influence the recording of trend data which occurs at one second intervals The default setting is the Normal Response Mode To set response mode 1 Access the OPTIO...

Page 50: ...e monitoring system to Homecare Mode 1 Before switching to Homecare Mode ensure that the alarm limits and patient type adult pediatric neonate are appropriate for the home patient 2 Access the OPTIONS...

Page 51: ...patient and the monitoring system the following screens appear Figure 4 12 Sensor Messages Figure 4 13 Homecare Mode Main Screen with Homecare Icon 4 7 3 Sleep Study Mode Set the monitoring system to...

Page 52: ...atient Mode then select Switch to Sleep Study Mode Figure 4 14 Switch to Sleep Study Mode 3 Confirm the entry into Sleep Study Mode or select Cancel Figure 4 15 Disabling of Alarms Message 4 Enter the...

Page 53: ...tory default operating mode If Homecare Mode or Sleep Study Mode is the current setting set the monitoring system back to Standard Mode when a clinician will be using it in a hospital or other profess...

Page 54: ...ptional Settings 4 8 1 Volume Use this option to adjust volume controls To set the desired audible tone volume 1 Access the OPTIONS Menu 2 Select Volume Figure 4 18 Volume Menu Item 3 Select and set t...

Page 55: ...4 8 2 Brightness Use this option to adjust the screen brightness To set the desired brightness 1 Access the OPTIONS Menu 2 Select Brightness Figure 4 20 Brightness Menu Item 3 Select and set the desi...

Page 56: ...1 100 100 95 Lower SpO2 alarm limit 20 99 90 85 Alarm Inhibition for SpO2 alarms Off SatSeconds alarmmanagementsetting Off 10 25 50 100 Off Pulse Rate PR Menu Upper pulse rate alarm limit 30 245 5 bpm...

Page 57: ...l Trend option Graphical trend view of trend data SpO2 On Off PR On Off SpO2 On PR On Table 4 3 Menu Structure and Factory Defaults Continued Item Available Selections Factory Default Adult Pediatric...

Page 58: ...Volume 1 Communication Settings Serial Connectivity Settings ASCII 19200 ASCII 115200 SPDout 19200 SPDout 115200 ASCII 19200 Nurse Call Settings NORMALLY NOR MALLY NORMALLY Alarm Priorities Prioritie...

Page 59: ...g alarm conditions It also saves all physiological alarm conditions and errors Trend data history remains in memory even if the monitoring system is powered off The monitoring system stores new data o...

Page 60: ...he knob again to reach the 1 to scroll through each individual event in that time period 3 After reviewing trend data press the Home button to exit the tabular trend view 5 3 Graphical Trend Data The...

Page 61: ...unding conditions 5 4 1 Nurse Call Interface WARNING Do not use the nurse call feature as the primary source of alarm notification The audible and visual alarms of the monitoring system used in conjun...

Page 62: ...nto the nurse call port 3 Attach the alternate end of the cable into the host system To disconnect the nurse call cable 1 Grasp the RJ11 end of the cable and press down on the plastic tab on the cable...

Page 63: ...f the displayed values Connect the mini USB port to a PC for downloading trend data Any PC connected to the data port must be certified according to IEC 60950 All combinations of equip ment must be in...

Page 64: ...access to collected trend data Data transfer relies on existing communication software drivers for USB based devices already on the computer so should not require any modification of the drivers used...

Page 65: ...gain since the item highlighted is the Start option The status bar indi cating total percentage of the download appears and the Start option immediately changes to a Cancel option Note Users may choos...

Page 66: ...ck the HyperTerminal option 4 When the Connect Description window opens type in the desired file name in the Name field 5 Locate the proper icon by scrolling all the way to the far right of the icon f...

Page 67: ...e menu click New Connection and select a different COM port until data values scroll across the HyperTerminal screen To interpret downloaded trend data 1 Examine trend data on the HyperTerminal screen...

Page 68: ...er Alternatives Load the appropriate driver from the product CD or thumb drive into the connected computer The USB driver will automatically load Contact Technical Services or a local Covidien represe...

Page 69: ...computer PC 2 Copy the COVIDIEN USB to UART Bridge Driver zip file to the PC installing it in the desired program folder 3 Right click on the zipped folder 4 Select Extract All 5 Open the extracted f...

Page 70: ...the end user license agreement read it careful ly then click the button for accepting the terms of the license 13 Click Next to formally accept the agreement 14 Review the Destination Folder mapping T...

Page 71: ...tart menu click the Settings menu option and select the Control Panel option 20 Select the System option to open the System Properties window 21 Click the Hardware tab then the Device Manager button F...

Page 72: ...igure 5 10 Sample Hardware List in Device Manager Window 23 Double click the Silicon Labs CP210x USB to UART Bridge option Note The listed COM port should match the HyperTerminal COM port designation...

Page 73: ...ow 24 Click the Port Settings tab 25 Set the bits per second to one of the following baud rates 19200 or 115200 The factory default is 19200 bps Note The monitoring system s baud rate setting must mat...

Page 74: ...OK button to complete the process 27 Reference Todownloadtrenddata p 5 6 and proceed to step 8 utilizing HyperTerminal to connect to the monitoring system 5 4 3 Firmware Upgrades Contact a qualified s...

Page 75: ...res prior to initial installation in a clinical setting 6 2 Oximetry Considerations WARNING Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions pulse...

Page 76: ...emia causes decreased arterial oxygen content Although SpO2 readings may appear normal an anemic patient may be hypoxic Correcting anemia can improve arterial oxygen content The monitoring system may...

Page 77: ...nfluences the accuracy of sensor data since this may lead to adverse results WARNING Failure to cover the pulse oximetry sensor site with opaque material in high ambient light conditions may result in...

Page 78: ...roperly positioned on the patient High ambient light sources such as surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sun...

Page 79: ...em to operate correctly Caution This device has been tested and found to comply with the limits for medical devices related to IEC 60601 1 2 2007 and IEC 60601 1 2 2014 These limits are designed to pr...

Page 80: ...ed The monitoring system generates uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference with other susceptible...

Page 81: ...with a commercial nonabrasive cleaner Lightly wipe the top bottom and front surfaces of the monitoring system lightly For sensors follow cleaning instructions in the directions for use shipped with t...

Page 82: ...and negative terminals Do not charge the battery with polarities reversed Caution Covidien strongly recommends recharging the battery when it has not been recharged for six 6 or more months Caution F...

Page 83: ...e after a critically low battery alarm issues Reference the Service Manual Note Remove the battery if anticipating long periods of time between use or if storing the monitoring system Note Storing the...

Page 84: ...lly 7 6 Service WARNING Only a qualified service technician should remove the cover or access any internal components Caution Dispose of monitoring system in accordance with local requirements and reg...

Page 85: ...d service technician confirm the monitoring system is functioning correctly WARNING Only a qualified service technician should remove the cover or access any internal components If the monitoring syst...

Page 86: ...rosurgical device cell phone Replace the cable and or sensor Clean site MAXR No response to Power On Off button press Press the Power On Off button for more than one 1 second Ensure the power cord is...

Page 87: ...g date and time even after power reset it means inter nal battery for power backup is dead If the error continues contact Technical Services or a qualified service technician System consumes battery p...

Page 88: ...appropriate packing material to protect it during shipping Return the monitoring system by any shipping method that provides proof of deliv ery Data port does not function properly Ensure USB cable fi...

Page 89: ...nnector Connecting any other cable or sensor influences the accuracy of the sensor data which may lead to adverse results WARNING Do not use a damaged pulse oximetry sensor or pulse oximetry cable Do...

Page 90: ...SC PR 1 5 kg Nellcor neonatal SpO2 sensor non adhesive single patient use SC NEO 1 5 to 5 kg Nellcor adult SpO2 sensor non adhesive single patient use SC A 40 kg Nellcor adult neonatal SpO2 sensor wi...

Page 91: ...nonsterile DS 100A 40 kg Nellcor SpO2 sensor multi site reusable nonsterile D YS 1 kg Nellcor SpO2 ear sensor clip reusable nonsterile D YSE 30 kg Nellcor pediatric SpO2 sensor clip reusable nonsteril...

Page 92: ...to the adapter plate which attaches to the M Series arm The arm slides into the wall mount channel GCX roll stand The GCX roll stand attaches to the adapter plate 9 4 Biocompatibility Testing Biocompa...

Page 93: ...ability of the pulse oximeter to accurately measure SpO2 Reference Performance Considerations p 6 1 Pulse oximetry is based on two principles oxyhemoglobin and deoxyhemoglobin differ in their absorpt...

Page 94: ...D these coefficients are then used to determine SpO2 Additionally to compensate for differences in tissue thickness the light intensity of the sensor s LEDs is adjusted automatically Note During certa...

Page 95: ...s when saturation calculations exclude corrections for the effects of variables such as pH temperature the partial pressure of carbon dioxide PCO2 and 2 3 DPG that shift the relationship between PO2 a...

Page 96: ...nds each time it violates the alarm threshold SatSec onds monitors both degree and duration of desaturation as an index of desaturation severity Thus the SatSeconds feature helps distinguish clinicall...

Page 97: ...the duration of the event is two 2 seconds before saturation again exceeds the lower alarm threshold of 85 Because the SatSeconds alarm limit is set to 25 and the actual number of SatSec onds equals 1...

Page 98: ...e duration of the event is 15 seconds before saturation again exceeds the lower alarm threshold of 85 Because the SatSeconds alarm limit is set to 25 and the actual number of SatSec onds equals 15 the...

Page 99: ...lower alarm threshold of 85 Since the patient s saturation does not return to a value over the lower alarm threshold within 2 5 seconds an alarm sounds At this level of saturation the event cannot exc...

Page 100: ...ty Net is for patients with saturation levels frequently below the limit but not staying below the limit long enough for the SatSeconds time setting to be reached When three or more limit violations o...

Page 101: ...6 kg 3 5 lbs including battery Dimensions 255 82 155 mm 10 04 x 3 23 x 6 10 in Display Screen size 109 22 mm 4 3 in measured diagonally Screen type TFT LCD white LED backlight viewing cone of 30 and...

Page 102: ...ep the SatSeconds feature enabled with no external communication no audible alarms and at 25 C 5 C 10 8 V 2200 mAh Voltage and capacity of Li Ion 10 hour1 10 8 V 4400 mAh Compliance 91 157 EEC Fast ac...

Page 103: ...table level 1 8 Pitch 20Hz 697 Hz Effective pulse duration td 180 msec IEC 60601 1 8 Number of pulses in burst 3 interburst interval of 8 sec IEC 60601 1 8 Repetitions Continually Low Priority Alarm T...

Page 104: ...ume level Not changeable Pitch 20Hz 780 Hz Pulse width 20msec 1500 msec Number of pulses N A Repetitions No repeat Table 11 2 Tone Definitions Continued Tone Category Description Table 11 3 Trends Typ...

Page 105: ...ries by sensor type Refer to the Sensor Accuracy Grid at www covidi en com rms 2 Accuracy specifications were validated using measurements of healthy non smoking adult vol unteers during controlled hy...

Page 106: ...own true saturation and pulse rate of the input signals 7 Motion performance was validated during a controlled hypoxia blood study over an SaO2 span of 70 to 98 and a convenience sample heart rate ran...

Page 107: ...adings of the monitoring system and increased EMI emissions or decreased electromagnetic immunity of the monitoring system Standards Compliance EN ISO 80601 2 61 Edition 1 0 EN IEC 60601 1 Edition 3 1...

Page 108: ...nce with ISO 10993 1 The monitoring system is suitable for prescription use only in the specified electro magnetic environments in accordance with the IEC 60601 1 2 2007 and IEC 60601 1 2 2014 standar...

Page 109: ...fied below The cus tomer or the user of the monitoring system should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emission CISPR 11 G...

Page 110: ...ality should be that of a typical commercial or hospital environment Surge IEC EN 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should b...

Page 111: ...smitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the com pl...

Page 112: ...ed Maximum Output Power P of Transmitter in Watts Separation Distance According to Frequency of Transmitter in Meters 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 7 GHz 0 01 0 12 0 02 0 04 0 10 0...

Page 113: ...70 GMRS 460 FRS 460 FM 5kHz deviation 1 kHz sine 2 0 3 28 710 704 to 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 to 960 GSM 800 900 TETRA 800 iDEN820 CDMA 850 LTE Band 5 Pulse...

Page 114: ...creased electromagnetic immunity of the monitoring system 11 8 3 Safety Tests Ground Integrity 100 milliohms or less Leakage Current The following tables display the maximum earth and enclosure leakag...

Page 115: ...ormal Normal Closed Closed 5 mA Single Fault Open Closed 10 mA Closed Open Normal Reversed Closed Closed 5 mA Single Fault Open Closed 10 mA Closed Open Touch Current Condition AC Line Polarity Neutra...

Page 116: ...ANSI AAMI ES 60601 1 Normal Normal Closed Closed 100 A Single Fault Open Closed 500 A Closed Open Normal Reversed Closed Closed 100 A Single Fault Open Closed 500 A Closed Open Patient Leakage Current...

Page 117: ...s p 4 10 Audible Alarm Indicators p 4 11 and Tone Definition p 11 3 Physiological alarms and priorities Reference Manage Alarms and Alarm Limits p 4 10 Visual indicator of power source Reference Front...

Page 118: ...Product Specifications Page Left Intentionally Blank 11 18 Operator s Manual...

Page 119: ...surements of blood SaO2 by a CO oximeter and ECG heart rate This is achieved through paired observations of SpO2 and SaO2 values over the SaO2 accuracy range of 70 to 100 on a group of healthy adult v...

Page 120: ...ubject was instructed to tap with finger tips to maintain consistency of area of effect on the pressure pad and to prevent resting hand on pressure pad between motions so that only qualified taps are...

Page 121: ...enrolled into the study The mean age of study participants was 30 36 7 85 years with a range of 22 to 46 years of age Three subjects had dark pigmentation dark olive to extremely dark Weight ranged fr...

Page 122: ...r on the plots Subject identification numbers are indicated in the legend to the left of each plot Table A 2 Pulse Rate Accuracy Results No Motion Sensor Motion of Data Points ARMS BPM Pulse Rate Acce...

Page 123: ...Results Operator s Manual A 5 Figure A 1 Modified Bland Altman for SpO2 All Data No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 3 Upper 95 LoA 2 SaO2 4 Mean Bias 5 Lower 95 LoA...

Page 124: ...land Altman for Pulse Rate All Data No Motion ECG HR vs Pulse Rate ECG HR Modified Bland Altman plots for the SpO2 data by sensor type are presented in Figure A 3 through Figure A 9 1 Pulse Rate ECG H...

Page 125: ...Results Operator s Manual A 7 Figure A 3 Modified Bland Altman for SpO2 MAXA Sensor No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 3 Upper 95 LoA 2 SaO2 4 Mean Bias 5 Lower 95 LoA...

Page 126: ...Clinical Studies A 8 Operator s Manual Figure A 4 Modified Bland Altman for SpO2 MAXN Sensor No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 3 Upper 95 LoA 2 SaO2 4 Mean Bias 5 Lower 95 LoA...

Page 127: ...Results Operator s Manual A 9 Figure A 5 Modified Bland Altman for SpO2 MAXFAST Sensor No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 3 Upper 95 LoA 2 SaO2 4 Mean Bias 5 Lower 95 LoA...

Page 128: ...Clinical Studies A 10 Operator s Manual Figure A 6 Modified Bland Altman for SpO2 SC A Sensor No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 3 Upper 95 LoA 2 SaO2 4 Mean Bias 5 Lower 95 LoA...

Page 129: ...Results Operator s Manual A 11 Figure A 7 Modified Bland Altman for SpO2 DS 100A Sensor No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 3 Upper 95 LoA 2 SaO2 4 Mean Bias 5 Lower 95 LoA...

Page 130: ...Clinical Studies A 12 Operator s Manual Figure A 8 Modified Bland Altman for SpO2 OxiCliq A Sensor No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 3 Upper 95 LoA 2 SaO2 4 Mean Bias 5 Lower 95 LoA...

Page 131: ...ified Bland Altman for SpO2 D YSE Sensor No Motion SaO2 vs SpO2 SaO2 Modified Bland Altman plots for the pulse rate data by sensor type are presented in Figure A 10 through Figure A 16 1 SpO2 SaO2 3 U...

Page 132: ...Studies A 14 Operator s Manual Figure A 10 Modified Bland Altman for Pulse Rate MAXA Sensor No Motion ECG HR vs Pulse Rate ECG HR 1 Pulse Rate ECG HR BPM 3 Upper 95 LoA 2 ECG HR BPM 4 Mean Bias 5 Lowe...

Page 133: ...lts Operator s Manual A 15 Figure A 11 Modified Bland Altman for Pulse Rate MAXN Sensor No Motion ECG HR vs Pulse Rate ECG HR 1 Pulse Rate ECG HR BPM 3 Upper 95 LoA 2 ECG HR BPM 4 Mean Bias 5 Lower 95...

Page 134: ...tudies A 16 Operator s Manual Figure A 12 Modified Bland Altman for Pulse Rate MAXFAST Sensor No Motion ECG HR vs Pulse Rate ECG HR 1 Pulse Rate ECG HR BPM 3 Upper 95 LoA 2 ECG HR BPM 4 Mean Bias 5 Lo...

Page 135: ...lts Operator s Manual A 17 Figure A 13 Modified Bland Altman for Pulse Rate SC A Sensor No Motion ECG HR vs Pulse Rate ECG HR 1 Pulse Rate ECG HR BPM 3 Upper 95 LoA 2 ECG HR BPM 4 Mean Bias 5 Lower 95...

Page 136: ...tudies A 18 Operator s Manual Figure A 14 Modified Bland Altman for Pulse Rate DS 100A Sensor No Motion ECG HR vs Pulse Rate ECG HR 1 Pulse Rate ECG HR BPM 3 Upper 95 LoA 2 ECG HR BPM 4 Mean Bias 5 Lo...

Page 137: ...Operator s Manual A 19 Figure A 15 Modified Bland Altman for Pulse Rate OxiCliq A Sensor No Motion ECG HR vs Pulse Rate ECG HR 1 Pulse Rate ECG HR BPM 3 Upper 95 LoA 2 ECG HR BPM 4 Mean Bias 5 Lower...

Page 138: ...ltman for Pulse Rate D YSE Sensor No Motion ECG HR vs Pulse Rate ECG HR Correlation plots for all the data are presented in Figure A 17 and Figure A 18 for SpO2 and pulse rate respectively 1 Pulse Rat...

Page 139: ...Results Operator s Manual A 21 Figure A 17 Correlation Plot for SpO2 All Data No Motion SaO2 vs SpO2 1 SpO2 2 SaO2...

Page 140: ...ta below is presented to show each decade which includes the RMSD root mean square difference and N values RMSD and ARMS are the same ARMS is used for pooled data across the whole study to represent a...

Page 141: ...e criteria for the MAXA MAXN and MAXFAST sensors during non motion conditions Table A 4 RMSD of SpO2 per Plateau No Motion SpO2 Range Room Air Plateau 90 Plateau 80 Plateau 70 Plateau N 978 1102 1034...

Page 142: ...plots Subject identification numbers are indicated in the legend to the left of each plot Figure A 19 Modified Bland Altman for SpO2 All Data Low Saturation SaO2 vs SpO2 SaO2 MAXFAST No 281 0 81 3 0 P...

Page 143: ...for Pulse Rate All Data Low Saturation ECG HR vs Pulse Rate ECG HR Correlation plots for all the data are presented in Figure A 21 and Figure A 22 for SpO2 and pulse rate respectively 1 Pulse Rate EC...

Page 144: ...Clinical Studies A 26 Operator s Manual Figure A 21 Correlation Plot for SpO2 All Data Low Saturation SaO2 vs SpO2 1 SpO2 2 SaO2...

Page 145: ...l Data Low Saturation ECG HR vs Pulse Rate 1 Pulse Rate BPM 2 ECG HR BPM Table A 7 RMSD of SpO2 per Decade Low Saturation SpO2 Range 80 70 69 60 N 637 569 RMSD 1 73 2 69 Table A 8 RMSD of SpO2 per Pla...

Page 146: ...on are presented in Table A 9 and Table A 10 As shown in the tables both SpO2 and pulse rate meet the acceptance criteria for both the MAXA and MAXN sensor during motion Modified Bland Altman plots fo...

Page 147: ...epresented by a unique color on the plots Subject identification numbers are indicated in the legend to the left of each plot Figure A 23 Modified Bland Altman for SpO2 All Data Motion SaO2 vs SpO2 Sa...

Page 148: ...d Bland Altman for Pulse Rate All Data Motion ECG HR vs Pulse Rate ECG HR Modified Bland Altman plots for the SpO2 data by sensor type are presented in Figure A 25 and Figure A 26 1 Pulse Rate ECG HR...

Page 149: ...Results Operator s Manual A 31 Figure A 25 Modified Bland Altman for SpO2 MAXA Sensor Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 3 Upper 95 LoA 2 SaO2 4 Mean Bias 5 Lower 95 LoA...

Page 150: ...A 26 Modified Bland Altman for SpO2 MAXN Sensor Motion SaO2 vs SpO2 SaO2 Modified Bland Altman plots for the pulse rate data by sensor type are presented in Figure A 27 and Figure A 28 1 SpO2 SaO2 3...

Page 151: ...ults Operator s Manual A 33 Figure A 27 Modified Bland Altman for Pulse Rate MAXA Sensor Motion ECG HR vs Pulse Rate ECG HR 1 Pulse Rate ECG HR BPM 3 Upper 95 LoA 2 ECG HR BPM 4 Mean Bias 5 Lower 95 L...

Page 152: ...Altman for Pulse Rate MAXN Sensor Motion ECG HR vs Pulse Rate ECG HR Correlation plots for all the data are presented in Figure A 29 and Figure A 30 for SpO2 and pulse rate respectively 1 Pulse Rate...

Page 153: ...rator s Manual A 35 Figure A 29 Correlation Plot for SpO2 All Data Motion SaO2 vs SpO2 Figure A 30 Correlation Plot for Pulse Rate All Data Motion ECG HR vs Pulse Rate 1 SpO2 2 SaO2 1 Pulse Rate BPM 2...

Page 154: ...w is presented to show each decade which includes the RMSD and N values There is no acceptance criteria associated with decade levels of hypoxia In Table A 12 SpO2 RMSD is presented per decade RMSD fo...

Page 155: ...sted with the Nellcor bedside SpO2 patient monitoring system during non motion conditions across the SaO2 saturation range of 60 to 100 A 4 2 Motion The pooled results indicate that the observed SpO2...

Page 156: ...Clinical Studies Page Left Intentionally Blank A 38 Operator s Manual...

Page 157: ...rence 6 5 F Feature Nurse call interface 5 3 SatSeconds alarm management 10 4 Trend data download 5 5 Fractional Saturation 10 2 Front Panel 2 3 2 4 11 7 Functional Saturation 10 2 G Ground Integrity...

Page 158: ...agile 2 8 Humidity limitations 2 8 Keep dry 2 8 Manufacturer 2 8 Prescription only 2 8 Temperature limitations 2 8 This side up 2 8 Type BF 2 8 UL listed 2 8 T Tabular Trend Data 5 2 Technical Assista...

Page 159: ......

Page 160: ...onally registered trademarks of Covidien AG brands are trademarks of their respective owners Other brands are trademarks of a Covidien company 2014 Covidien All rights reserved Covidien llc 15 Hampshi...

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