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Adverse Events or Deviations

Operator’s Manual

105

Figure A-1.

Modified Bland-Altman Plot

A.5

Adverse Events or Deviations

The study was conducted as expected with no adverse events and no devia-
tions from the protocol.

Test Sensor;
Avg CO-oximeter value 70-100% SpO

Avg CO-oximeter value 70-100% SpO

Oximetry board with MAX-A sensor

Trendline of MAX-A sensor

Oximetry board with MAX-N sensor

Trendline of MAX-N sensor

Oximetry board with MAX-FAST sensor

Trendline of MAX-FAST sensor

Содержание Nellcor

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

Страница 2: ...r internationally registered trademarks of Covidien llc This document contains proprietary information that is protected by copyright All rights reserved Reproduction adaptation or translation without prior written permission is prohib ited except as allowed under the copyright laws ...

Страница 3: ... Product Views 11 2 4 1 Front Panel and Display Components 11 2 4 2 Rear Panel 15 2 4 3 Product and Carton Label Symbols 16 3 Installation 3 1 Overview 17 3 2 Safety Reminders 17 3 3 Unpacking and Inspection 18 3 4 Setup 19 3 4 1 Connecting to Power 20 3 4 2 Using the Internal Battery 21 3 4 3 Connecting a Nellcor Pulse Oximetry Sensor 22 4 Operation 4 1 Overview 25 4 2 Safety Reminders 25 4 3 Use...

Страница 4: ...aphical Trend Data 46 5 4 External Data Communication 47 5 4 1 Nurse Call Interface 48 5 4 2 Trend Data Download 49 5 4 3 Firmware Upgrades 62 6 Performance Considerations 6 1 Overview 63 6 2 Oximetry Considerations 63 6 2 1 Pulse Rates 63 6 2 2 Saturation 63 6 3 Performance Considerations 64 6 3 1 Overview 64 6 3 2 Patient Conditions 64 6 3 3 Sensor Performance Considerations 65 6 3 4 Reducing EM...

Страница 5: ...0 4 Functional Testers and Patient Simulators 82 10 5 Unique Technologies 83 10 5 1 Functional versus Fractional Saturation 83 10 5 2 Measured versus Calculated Saturation 84 10 5 3 84 10 5 4 Data Update Period Data Averaging and Signal Processing 84 10 6 SatSeconds Alarm Management Feature 85 10 6 1 First SpO2 Event 86 10 6 2 Second SpO2 Event 87 10 6 3 Third SpO2 Event 88 10 6 4 The SatSeconds S...

Страница 6: ...anufacturer s Declaration 96 11 9 1 BasicsElectromagnetic Compatibility EMC 96 11 9 2 Sensor and Cable Compliance 100 11 9 3 Safety Tests 100 A Clinical Studies A 1 Overview 103 A 2 Methods 103 A 3 Study Population 104 A 4 Study Results 104 A 5 Adverse Events or Deviations 105 A 6 Conclusion 106 ...

Страница 7: ...Table 11 1 Transport Storage and Operating Condition Ranges 92 Table 11 2 Tone Definitions 93 Table 11 3 Trends 94 Table 11 4 Pulse Oximetry Sensor Accuracy and Ranges 95 Table 11 5 Sound Pressure in Decibels 95 Table 11 6 Electromagnetic Emissions Guidelines 97 Table 11 7 Electromagnetic Immunity Guidelines 98 Table 11 8 Recommended Separation Distances 99 Table 11 9 Cables and Sensors 100 Table ...

Страница 8: ...viii ...

Страница 9: ...lar Trend Data Screen 45 Figure 5 2 Graphical Trend Data Screen 47 Figure 5 3 Nurse Call Interface Pin Layout 49 Figure 5 4 Trend Data Download Option 51 Figure 5 5 Trend Data Download Status 52 Figure 5 6 Sample Trend Data Printout 55 Figure 5 7 Sample Bridge Driver Installer window 57 Figure 5 8 Sample New Hardware Wizard Screen 57 Figure 5 9 Sample DEVICE MANAGER button under hardware tab 59 Fi...

Страница 10: ...Page Left Intentionally Blank x ...

Страница 11: ...pO2 Patient Monitoring System Other important safety information appears throughout the manual The Nellcor Bedside SpO2 Patient Monitoring System will be referred to as the monitoring system throughout this manual 1 2 1 Safety Symbols Table 1 1 Safety Symbol Definitions Symbol Definition WARNING Warnings alert users to potential serious outcomes death injury or adverse events to the patient user o...

Страница 12: ... route patient cabling to reduce the possibility of patient entanglement or strangulation WARNING Do not touch signal input signal output or other connectors and the patient simultaneously WARNING Do not lift or carry the monitoring system by the pulse oximetry sensor or pulse oximetry interface cable The cable may disconnect and cause the monitoring system to drop on a patient or cause damage to ...

Страница 13: ...toring system is intended 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 result in inaccurate measurements Pulse oximetry readings and pulse signals can be affected by certain environmental conditions pulse oximetry sensor application errors and certain...

Страница 14: ... not spray pour or spill any liquid on the monitoring system its accessories connectors switches or openings in the chassis since this may cause damage to the monitoring system Never place fluids on the monitoring 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 monitor...

Страница 15: ...10993 1 The use of accessories sensors and cables other than those specified may result in inaccurate readings of the monitoring system and increased emission and or decreased electromagnetic immunity of the monitoring system Caution Where the integrity of the external protective conductor in the installation or its arrangement is in doubt the monitoring system operates from its battery Caution Th...

Страница 16: ...he monitoring system thoroughly read the this manual Nellcor Pulse Oximetry Sensor Directions for Use Guides sensor selection and usage Before attaching any of the various Covidien approved pulse oximetry sensors to the monitoring system refer to the individual Directions for Use Saturation Accuracy Grid Provides sensor specific guidance related to desired SpO2 saturation accuracy measurements Ava...

Страница 17: ...ensive changes may require a new document part number 1 5 Warranty Information The information contained in this document is subject to change without notice 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 liable for errors contained herein or for in...

Страница 18: ...Introduction 8 Operator s Manual Page Left Intentionally Blank ...

Страница 19: ... saturation SpO2 Functional measure of oxygenat ed hemoglobin relative to the sum of oxyhemoglobin and deoxyhemoglobin Pulse rate PR Detected heart pulsations in beats per minute Plethysmographic waveform Pleth A non normalized waveform that rep resents relative pulsatile strength Operating status State of the monitoring system including alarm conditions and messages Patient data Real time trend d...

Страница 20: ...m is intended for prescription use only with neonatal pediatric and adult patients and for patients who are well or poorly perfused in hospi tals hospital type facilities and intra hospital transport Note Hospital use typically covers such areas as general care floors GCFs operating rooms special procedure areas intensive and critical care areas within the hospi tal and in hospital type facilities...

Страница 21: ...ions Navigation p 4 28 3 Power On Off button Press and hold to turn on or off the monitoring system using AC power or Lithium ion batteries Ref erence Menu Options Navigation p 4 28 4 USB port USB A type Use USB interface for firmware upgrades 5 USB port mini USB B type Use mini USB interface for trend data downloads 6 Jog dial Use to navigate and control of display and monitoring system functions...

Страница 22: ...pulse becomes stronger more bars light with each pulse 5 SatSeconds icon The SatSeconds feature provides alarm management for mild or brief SpO2 limit violations When the SatSeconds feature is enabled the SatSeconds icon fills in the clockwise direction as the SatSeconds alarm management system detects SpO2 readings outside of the limits setting The Sat Seconds icon empties in the counterclockwise...

Страница 23: ... charge remains the monitoring system automatically shut down Connect the monitoring system to AC power to avoid any loss of trend data or settings 9 AC power indicator Lights continuously when connected to AC power 10 Battery charge indicator Lights when the monitoring system is charging an internal 5 or 10 hour battery 11 Interference indicator Lights when the monitoring system detects degraded ...

Страница 24: ...mit values 18 Informative message area Contains messages to notify the user of a condition or a request for action 19 Plethysmographic pleth waveform This non normalized waveform uses real time sensor sig nals reflecting relative pulsatile strength of incoming sig nals 1 Degradation can be caused by ambient light poor sensor placement electrical noise electrosurgical interference patient activity ...

Страница 25: ...Product Views Operator s Manual 15 2 4 2 Rear Panel Figure 2 3 Rear Panel Components 1 Equipotential terminal 3 Battery cover 2 Nurse call port 4 AC power connector ...

Страница 26: ...nufacture Prescription only device Keep dry Attention consult accompanying documents Fragile Atmospheric pressure limitations UL listed Humidity limitations CE Mark Temperature limitations Manufacturer This side up EU representative Must consult instructions for use Consult instructions for use Protection against fluid ingress Proper waste disposal for electrical and electronic equipment ...

Страница 27: ...n Such exposure may cause inaccurate performance or device failure Reference Product Specifications p 11 91 WARNING The monitoring system should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary observe the monitoring system to verify normal operation in the desired configuration WARNING Do not use any monitoring system pulse oximetry sensor cables or ...

Страница 28: ...ection The monitoring system is shipped in a single carton Examine the carton carefully for evidence of damage Contact Covidien Technical Services immediately if the carton appears damaged Do not return all packing material and the monitoring system prior to contacting Covidien Reference Technical Services p 1 6 Note A qualified service technician should verify the performance of the monitoring sy...

Страница 29: ... source Caution If the integrity of the AC power source is in doubt ensure the monitoring system internal battery is fully charged Table 3 1 Standard Items Item Quantity Nellcor Bedside SpO2 Patient Monitoring System 1 Nellcor pulse oximetry interface cable 1 Compact Disc CD and or Operator s Manual 1 1 Covidien provides soft copy of monitoring system manuals on a compact disc for easy access and ...

Страница 30: ...unded AC outlet 4 If necessary connect grounding wire Connect the grounding wire connector to the rear panel s equipotential terminal Attach the clip end of the grounding wire to the grounding terminal on the wall 5 Ensure the Battery Charge Indicator lights Note Even if the monitoring system is not turned on the Battery Charge Indicator lights when the AC power cord is connected into a mains outl...

Страница 31: ...charging the battery over a period of time may shorten the time between the low battery alarm and power off Have a qualified service technician periodically check the internal battery or replace it if necessary 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 fully discharged battery A lit bat...

Страница 32: ... operating on internal battery the monitoring system 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 Reference Connecting to Power p 3 20 2 Verify the Battery Charge Indicator lights 3 4 3 Connecting a Nellcor Pulse Oximetry Sensor WARNING Incorrect application or use of an SpO...

Страница 33: ...quipment Refer ence Periodic Safety Checks p 7 72 Reference Nellcor Pulse Oximetry Sen sors p 9 77 for details regarding sensor selection To fully connect an Nellcor pulse oximetry sensor 1 Select an appropriate compatible Nellcor pulse oximetry sensor for the patient and desired application When selecting a sensor consider the patient s weight and activity adequacy of perfusion availability of se...

Страница 34: ...e monitoring system could lose signal from patient Note Physiological conditions medical procedures or external agents that may interfere with the monitoring system s ability to detect and display measurements include dysfunctional hemoglobin arterial dyes low perfusion dark pigment and externally applied coloring agents such as nail polish dye or pigmented cream ...

Страница 35: ...nsor site 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 radiated electromagnetic signals from sources external to the patient and the monitoring system can cause inaccurate measurement readings Do not rely entirely on the monitoring system s reading...

Страница 36: ...he pulse oximetry cable or both 4 3 User Interface 4 3 1 Turning on the Monitoring System WARNING Ensure the speaker is clear of any obstruction Failure to do so may result in an inaudible tone Caution If any indicator or display element does not light or the speaker does not sound do not use the monitoring system Instead contact a qualified service technician Before using the monitoring system in...

Страница 37: ... system should a repeating high pitched alarm tone occur at power on Instead please contact Technical Services or a qualified service technician 4 3 2 Turning off the Monitoring System After using the monitoring system turn it off safely To turn off the monitoring system 1 Press the Power On Off button on the right of the device for approximately one second 2 Observe the message System is shutting...

Страница 38: ... at power on and remains lit until power off 3 Alarm Audio Paused button Press this orange button for less than two 2 seconds to disable or re enable audible alarms This button illuminates at power on and remains lit until power off Rotate or press the jog dial to navigate among various portions of the screen and to select menu items Note If a user presses and holds the RETURN button while accessi...

Страница 39: ...enu SatSeconds alarm management setting Off 10 25 50 100 Upper 21 100 SpO2 alarm limit Lower 20 99 SpO2 alarm limit Alarm Inhibition for SpO2 alarms 100 Depends on patient mode Ref erence Table 4 4 on page 43 PULSE RATE PR Menu Upper 30 245 pulse rate alarm limit Lower 25 240 pulse rate alarm limit Alarm Inhibition for pulse rate alarms OPTIONS Menu VOLUME Alarm Volume 1 8 5 Key Beep Volume Off 1 ...

Страница 40: ... SpO2 Menu with Audio Alarm Selected SATSECONDS option SatSeconds alarm management setting Off 10 25 50 100 100 PATIENT MODE Menu ADULT option Sets Alarm Limits to standard default thresholds for adult patients Reference Table 4 4 on page 43 PEDIATRIC option Sets Alarm Limits to standard default thresholds for pediatric patients NEONATE option Sets Alarm Limits to standard default thresholds for n...

Страница 41: ...e field 2 Press the jog dial 3 Rotate the jog dial until reaching the desired field Available SpO2 alarm limit thresholds SatSeconds alarm management values include OFF 10 25 50 100 The default value is 100 Reference SatSeconds Alarm Management Feature p 10 85 Upper and lower SpO2 alarm limit thresholds SpO2 alarm inhibition to disable audible alarms for SpO2 limit violations Pulse Rate alarm limi...

Страница 42: ...OPTIONS Menu Caregivers may choose from Volume Mode or Trend Data menu options To access the OPTIONS Menu 1 Rotate the jog dial to highlight the OPTIONS Menu icon 2 Press the jog dial to access the OPTIONS Menu Volume Access this menu option to adjust volume controls To set the desired audible tone volume 1 Access the OPTIONS Menu 2 Rotate the jog dial to highlight VOLUME Figure 4 5 Volume Selecti...

Страница 43: ...ishes the rate at which the monitor ing system responds to changes in the SpO2 data The calculation of pulse rate and the recording of trend data are not affected The response mode setting does not affect the algorithm s 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 mo...

Страница 44: ...de Menu Note When in the Fast Response Mode the monitoring system may produce more SpO2 and pulse rate alarms than expected Trend Data Download Access this menu option to download patient trend data Reference Trend Data Download p 5 49 Delete All Trend Data Access this menu option to delete all patient trend data from memory To delete all trend data 1 Access the OPTIONS Menu 2 Rotate the jog dial ...

Страница 45: ...ial to select RETURN then press to access the OPTIONS menu Service Menu Only a qualified service technician may change Service Menu settings A pass code is required for access Refer to the Service Manual for instructions 4 4 4 ALARM LIMITS Menu WARNING Do not pause the audible alarm or decrease its volume if patient safety could be compromised WARNING Check alarm limits to ensure they are appropri...

Страница 46: ...e left of the dynamic SpO2 value Reference Factory Defaults p 4 43 for default alarm limit settings Pulse Rate PR numerical area Displays the pulse rate in beats per minute bpm The display value flashes zeros during loss of pulse alarms and flashes the pulse rate value on a yellow background when the pulse rate is outside of the alarm limits During Pulse Search the monitoring system continues to u...

Страница 47: ...it violations 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 values include OFF 10 25 50 100 The default value is 100 Reference SatSeconds Alarm Management Feature p 10 85 6 Press the jog dial to save the desired value 7 Rotate the jog dial to highlight anoth...

Страница 48: ...d pulse oximetry sensor based on body weight Reference the pulse oximetry sensor Directions for Use Adult Use for adults Pediatric Use for children Neonatal Use for newborns 4 Press the jog dial to save the desired mode 5 Press the RETURN button to exit PATIENT MODE 4 4 6 SpO2 WAVEFORM Menu Caregivers may choose to set sweep speed of the plethysmographic waveform and opt to view the tabular or gra...

Страница 49: ...Access to set the speed at which the SpO2 waveform trace moves across the screen The higher the sweep speed value the more data appears on the screen Sweep Speed options are 6 25 mm s 12 5 mm s and 25 0 mm s Tabular Trend Access to display the tabular trend view Reference Tabular Trend Data p 5 45 Graphical Trend Access to display the graphical trend view Reference Graphical Trend Data p 5 46 ...

Страница 50: ...m state The monitoring system uses both visual and audible indicators to identify high priority medium priority and low priority alarms Audible alarms include pitched tones beeps and a buzzing tone High priority alarms take precedence over medium and low priority alarms Reference Troubleshooting p 8 73 Table 4 2 Alarm Conditions Priority Rate Color Messages High Sounds every 4 s Red Steady message...

Страница 51: ...promised Audible alarm indicators include pitched tones and beeps Caregivers may choose to pause the audible alarm for the established Alarm Audio Paused period of 30 60 90 or 120 seconds Visual alarms continue during this time The factory default for audible alarm silence period is 60 seconds To set one of the listed alternate periods as an institutional default have a qualified service technicia...

Страница 52: ... tones during the Alarm Audio Paused period press the Alarm Audio Paused button again If another alarm occurs during the Alarm Audio Paused period the monitoring system re enables all audio tones To pause an audible alarm 1 Press the Alarm Audio Paused button 2 To cancel press the Alarm Audio Paused button again If the Alarm Audio Paused period is enabled the audible alarm is not active for the sp...

Страница 53: ...n Factory Default Adult Pediatric Neonatal SpO2 SpO2 Upper Alarm Limit 21 to 100 1 steps 100 95 SpO2 Lower Alarm Limit 20 to 99 1 steps 90 85 SpO2 Limit Alarm Inhibition On Off Off SatSeconds Alarm Off 10 25 50 100 100 Pulse Rate Pulse Rate Upper Alarm Limit 30 to 245 bpm 5 bpm steps 170 bpm 200 bpm Pulse Rate Lower Alarm Limit 25 to 240 bpm 5 bpm steps 50 bpm 75 bpm 100 bpm PR Limit Alarm Inhibit...

Страница 54: ...se Mode Normal Fast Normal Trend Data Download Settings1 Baud Rates 19200 38400 57600 115200 bps 19200 bps Protocol ASCII 1 ASCII 2 ASCII 1 Sweep Speed 6 25 12 5 25 0 mm s 25 0 mm s Power On Settings1 Factory default Last Settings Institu tional Defaults Last Settings Language1 Chinese Czech Danish Dutch Eng lish Finnish French German Greek Italian Japanese Korean Norwe gian Polish Portuguese Russ...

Страница 55: ...ng system begins measuring vital signs it saves data every four 4 seconds It also saves all physiological alarm conditions and errors Trend data history remains in memory even if the monitoring system is powered off The moni toring system stores new data over the oldest data when the buffer is full 5 2 Tabular Trend Data The monitoring system presents trend information in tabular format for all mo...

Страница 56: ...ll granularity more than once For instance use the 500 to scroll quickly to the desired time stamp then press the jog dial again to reach the 1 to scroll through each individual event in that time period 3 After reviewing trend data press the RETURN button to exit the tabular trend view 5 3 Graphical Trend Data The monitoring system presents trend information in a single graph for all monitored pa...

Страница 57: ... reviewing trend data press the RETURN button to exit the graphical trend view 5 4 External Data Communication WARNING Any connections between this monitoring system and other devices must comply with applicable medical systems safety standards such as IEC 60601 1 Failure to do so may result in unsafe leakage current and grounding conditions The monitoring system provides external connectors on th...

Страница 58: ...oes not function with Alarm Audio Paused Caution Test the nurse call function prior to use especially when setting up the monitoring system in a new location One way to test the nurse call function is to create an alarm condition for example sensor disconnect and verify the nurse call system properly activates Note Communication Nurse Call Interface is limited to inside a single institution The nu...

Страница 59: ...r both relays To connect the nurse call cable 1 Grasp the RJ11 end of the cable 2 Firmly insert into the nurse call port 3 Attach the alternate end of the cable into the host system 5 4 2 Trend Data Download Caution Anyone who connects a PC to the data output port configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of IEC Standard 60...

Страница 60: ... do so users must export trend data using the ASCII 2 format option Have a qualified service technician set this option prior to attempting a data download System Compatibility Prerequisites Windows Vista XP Server 2003 2000 Pentium 100 MHz CPU 256 MB RAM HyperTerminal or equivalent software Hardware Mini USB data download cable CD if USB driver required The COM port on the side of the monitoring ...

Страница 61: ...IONS Menu 4 Rotate the jog dial to select the TREND DATA DOWNLOAD submenu option Figure 5 4 Trend Data Download Option 5 Press the jog dial to access the TREND DATA DOWNLOAD Menu 6 Connect a mini USB cable from the monitoring system to the computer a Grasp the mini USB end of the cable b Firmly insert into the bottom mini USB data port c Firmly insert the USB end of the cable into a USB port on th...

Страница 62: ...computer screen for a scrolling trend data record If no trend data values appear check connectivity and ensure the personal computer con tains HyperTerminal software If this is all operational verify patient trend data history exists on the monitoring system Contact Technical Services or a qualified service technician for assistance 11 Wait for the OUTPUT COMPLETE message to indicate the download ...

Страница 63: ...ble to the monitoring system the proper COM port option will not appear in the list 8 When the Connect To window opens find the CONNECT USING option and click the down arrow to identify possible modem options 9 Select the desired COM port 10 Click the OK button 11 In the COM PROPERTIES window set the appropriate values a Set the baud rate bits per second to match the monitoring system The factory ...

Страница 64: ... spreadsheet or on a print out from the personal computer Table 5 1 Operating Status Codes Code Definition Code Definition AO Alarm off PH Pulse rate upper limit alarm AS Alarm silence PL Pulse rate lower limit alarm BU Battery in use PS Pulse search LB Low battery SD Sensor disconnect LM Loss of pulse with signal artifact SH Saturation rate upper limit alarm LP Loss of pulse SL Saturation rate lo...

Страница 65: ...R column until reaching the events of interest 4 Match the operating status codes to the following table for pertinent system infor mation Reference Operating Status Codes p 5 54 1 Product column headings Data source firmware version and system settings 2 Patient data column headings Lists appropriate time and data headings 3 Time column Real time clock date and time stamp 4 Output Complete Messag...

Страница 66: ... operating system languages may vary To install a USB driver from the compact disc 1 Insert the Nellcor Bedside SpO2 Patient Monitoring System compact disc CD into the designated personal 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 folder 6 Launc...

Страница 67: ...firmly engaging the USB end to the PC and the mini USB to the monitoring system 10 Allow the PC to sense the new hardware and load the InstallShield Wizard which guides users through the entire setup process Do not click the CANCEL button Figure 5 8 Sample New Hardware Wizard Screen 11 At the prompt from the InstallShield Wizard click on the NEXT button to copy the driver to the PC ...

Страница 68: ...T to formally accept the Destination Folder mapping 16 Click INSTALL in the resulting driver installer window Do not click the CANCEL button Note If Windows Security pops up select the option to install the driver anyway 17 Click the OK button to complete the installation in the resulting Success window 18 Reboot the PC for changes to take effect 19 From the START menu click the Settings menu opti...

Страница 69: ...External Data Communication Operator s Manual 59 Figure 5 9 Sample DEVICE MANAGER button under hardware tab 22 Select the Ports option from the resulting list ...

Страница 70: ...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 Reference To launch HyperTerminal p 5 52 ...

Страница 71: ...ator s Manual 61 Figure 5 11 Sample Initial USB to UART Bridge Properties Window 24 Click the Port Settings tab 25 Set the bits per second to one of four possible baud rates 19200 38400 57600 or 115200 The factory default is 19200 bps ...

Страница 72: ... button to complete the process 27 Reference To download trend data p 5 51 and proceed to step 8 utilizing HyperTerminal to connect to the monitoring system 5 4 3 Firmware Upgrades Contact a qualified service technician to perform any firmware upgrade to the monitoring system as described in the Service Manual ...

Страница 73: ...es 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 oximetry sensor application errors and certain patient conditions 6 2 1 Pulse Rates The monitoring system only reports pulse rates between 20 and 250 bpm Detected pulse rates above 250 bpm appear as 25...

Страница 74: ...nemia 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 fail to provide an SpO2 reading if hemoglobin levels fall below 5 gm dl Dysfunctional hemoglobins Dysfunctional hemoglobins such as carboxyhemo globin methemoglobin and sulphemoglobin are unable to c...

Страница 75: ...sor influences 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 inaccurate measurements Inaccurate Sensor Measurement Conditions A variety of conditions can cause inaccurate Nellcor pulse oximetry sensor measurements Incorrect application of the pulse oximet...

Страница 76: ...hts infrared heating lamps and direct sunlight can interfere with the performance of a Nellcor pulse oxime try sensor To prevent interference from ambient light ensure that the sensor is properly applied and cover the sensor site with opaque material If patient activity presents a problem try one or more of the following remedies to correct the problem Verify the Nellcor pulse oximetry sensor is p...

Страница 77: ...ce measurements may seem inappropriate or the monitoring system may not seem 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 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation Because of the proliferation of radio frequency transmitti...

Страница 78: ...ifferent from that to which the other device s are connected 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 devices in the vicinity Contact Technical Services for assistance 6 4 Obtaining Technical Assistance For technical information and assistance...

Страница 79: ...and front surfaces of the monitoring system lightly Disinfection Use a soft cloth saturated with a solution of 10 chlorine bleach in tap water lightly wiping the surface of the monitoring system For sensors follow cleaning instructions in the directions for use shipped with those components Before attempting to clean a Nellcor pulse oximetry sensor read the Directions for Use enclosed with the sen...

Страница 80: ... 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 Follow local government ordinances and recycling instructions regarding disposal or recycling of device components including batteries Caution Do not short circuit the battery as it may generate heat To av...

Страница 81: ...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 monitoring system for a long period without charging the battery may degrade battery capacity A full charge of a depleted battery takes over four 4 or eight 8 hours depending on the battery Regularly...

Страница 82: ... 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 regulations The monitoring system requires no routine service other than cleaning battery maintenance and service activity mandated by the institution For more infor mation reference the Service Manual The mo...

Страница 83: ...ed 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 system detects an error it displays an appropriate error code The Service Manual lists all error codes If an error occurs check and reseat all power connections and ensure the battery is fully charged If...

Страница 84: ...surgical device cell phone Replace the cable and or sensor Clean site MAX R 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 properly connected to the outlet Ensure AC indictor blinks Ensure it does not share the same AC power source with other equipment If the error continues contact Technical Services or a qualified servic...

Страница 85: ...ices or a qualified service tech nician Date and Time incorrect Set the time in the Options Menu Check if date setting format follows locale If the system displays wrong date and time even after power reset it means internal battery for power backup is dead If the error continues contact Technical Services or a qualified service tech nician System consumes battery power even with AC power connecti...

Страница 86: ...adouts of patient physiological measure ments wrongly tagged or missing patient data Reference Performance Considerations p 6 63 Check patient status Replace sensor or cable if necessary Check all connections and reposition if necessary Remove sources of electromagnetic interference Remove excessive ambient light Data port does not function properly Ensure USB cable firmly connected Disconnect USB...

Страница 87: ... connecting to the sensor connector 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 not use a sensor with exposed optical components WARNING Tissue damage can be caused by incorrect application or duration of use of a pulse oximetry sensor Inspect the sens...

Страница 88: ...ensor SKU Patient Size Nellcor Preemie SpO2 Sensor non adhesive Single patient use 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 with Wraps Reusable with adhesive OXI A N 3 or 40 kg Nellcor Pediatric Infant SpO2 Sensor with Wraps Reusable with adhes...

Страница 89: ...nal equipment for use with the monitoring system Nellcor Adult SpO2 Nasal Sensor Sterile single use only MAX R 50 kg Nellcor Forehead SpO2 Sensor MAX FAST 10 kg Nellcor Adult SpO2 Sensor Reusable Nonsterile DS 100A 40 kg Nellcor SpO2 Sensor Multisite Reusable Nonsterile D YS 1 kg Nellcor SpO2 Ear Clip Reusable Nonsterile D YSE 30 kg Nellcor Pediatric SpO2 Clip Reusable Nonsterile D YSPD 3 to 40 kg...

Страница 90: ... The pulse oximetry sensors have passed the recommended biocompatibility testing and are therefore in compli ance with ISO 10993 1 GCX Wall Mount Arm and Channel Attaches to the adapter plate which attaches to the arm GCX Roll Stand Attaches to the adapter plate Covidien Technical Services Patient Monitoring 15 Hampshire Street Mansfield MA 02048 USA 1 800 635 5267 1 925 463 4635 or contact a loca...

Страница 91: ...e ability of the pulse oximeter to accurately measure SpO2 Reference Perfor mance Considerations p 6 63 Pulse oximetry is based on two principles oxyhemoglobin and deoxyhemoglo bin differ in their absorption of red and infrared light measured using spectro photometry and the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse registered using plethy...

Страница 92: ...pO2 Additionally to compensate for differences in tissue thickness the light inten sity of the sensor s LEDs is adjusted automatically Note During certain automatic calibration functions the monitoring system may briefly display a flat line on the plethysmographic waveform This is a normal operation and does not require any user intervention 10 4 Functional Testers and Patient Simulators Some mode...

Страница 93: ... properly functioning monitoring system this difference will be reproducible over time and from monitoring system to monitoring system within the performance specifications of the test device 10 5 Unique Technologies 10 5 1 Functional versus Fractional Saturation This monitoring system measures functional saturation where oxygenated hemoglobin is expressed as a percentage of the hemoglobin that ca...

Страница 94: ...in Dissociation Curve 10 5 3 10 5 4 Data Update Period Data Averaging and Signal Processing The advanced signal processing of the OxiMax algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate depending on the measurement conditions The OxiMax algorithm automatically extends the dynamic averaging time required beyond seven 7 seconds during degraded or dif ficu...

Страница 95: ...onds Alarm Management Feature The monitoring system monitors the percentage of hemoglobin binding sites saturated with oxygen in the blood With traditional alarm management upper and lower alarm limits are set to alarm at specific SpO2 levels When the SpO2 level fluctuates near an alarm limit the alarm sounds each time it violates the alarm threshold SatSeconds monitors both degree and duration of...

Страница 96: ...ation 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 Sat Seconds equals 12 there is no audible alarm Figure 10 3 First SpO2 Event No SatSeconds Alarm 6 drop below the lower alarm limit threshold x 2 second duration below the lower threshold 12 SatSeconds no alarm ...

Страница 97: ... and the 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 Sat Seconds equals 15 there is no audible alarm Figure 10 4 Second SpO2 Event No SatSeconds Alarm 1 drop below the lower alarm limit threshold x15 second duration below the lower threshold 15 SatSeconds no alarm ...

Страница 98: ...arm 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 exceed 2 5 seconds without invok ing a SatSeconds alarm Figure 10 5 Third SpO2 Event Triggers SatSeconds Alarm 10 drop below the lower alarm limit threshold x2 5 second duration below the lower threshold 25 SatS...

Страница 99: ...ds Safety Net is for patients with saturation levels frequently below the limit but not staying below the limit long enough for the SatSec onds time setting to be reached When three or more limit violations occur within 60 seconds an alarm sounds even if the SatSeconds time setting has not been reached ...

Страница 100: ...Page Left Intentionally Blank 90 Operator s Manual Theory of Operations ...

Страница 101: ... lbs including battery Dimensions 255 82 165 mm 10 04 x 3 23 x 6 50 in Display Screen size 109 22 mm 4 3 in measured diagonally Screen type TFT LCD white LED backlight viewing cone of 30º and optimal viewing distance of 1 meter Resolution 480 272 pixel Controls Dial Jog dial control Buttons Power On Off Alarm Audio Paused Return Alarms Categories Patient status and system status Priorities Low med...

Страница 102: ...econds feature enabled with no external communication no audible alarms and at 25 ºC 5ºC 10 8 V 2200 mAh Voltage and capacity of Li Ion 10hour1 10 8 V 4400 mAh Compliance 91 157 EEC Fast acting fuse 2A 32VAC DC Fast acting fuse 500 mA 32VAC 50DC Table 11 1 Transport Storage and Operating Condition Ranges Transport and Storage Operating Conditions Temperature 20 ºC to 60 ºC 4 ºF to 140 ºF 5 ºC to 4...

Страница 103: ...evel Adjustable level 1 8 Pitch 20Hz 697 Hz Pulse width 20msec 150 msec IEC60601 1 8 Number of pulses in burst 3 interburst interval of 8 sec IEC60601 1 8 Repetitions Continually Low Priority Alarm Tone Volume level Adjustable level 1 8 Pitch 20Hz 488 Hz Pulse width 20msec 250 msec IEC60601 1 8 Number of pulses 1 interburst interval of 16 sec IEC60601 1 8 Repetitions Continually Alarm Reminder Ton...

Страница 104: ...ume level Not changeable Pitch 20Hz 813 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 Types Graphical and Tabular Memory Saves total 88000 data events Saves date and time alarm conditions pulse rate and SpO2 measurements Graphical Format Total 2 graphs A graph for SpO2 parameters A graph ...

Страница 105: ...acy ARMS range Reference the Clinical Studies section for test results For a complete listing of SpO2 accuracy across the full line of available Nellcor sensors contact Covidien a local Covidien representative or locate it online at www covidien com 70 to 100 2 digits neonates 3 digits Operating Range and Dissipation Red Light Wavelength Approximately 660 nm Infrared Light Wavelength Approximately...

Страница 106: ...th ISO10993 1 The use of accessories sensors and cables other than those specified may result in inaccurate readings of the monitoring system and increased emission and or decreased electromagnetic immunity of the monitoring system Standards Compliance EN ISO 9919 2009 EN ISO 80601 2 61 2011 EN IEC 60601 1 2005 EN IEC 60601 1 2 2nd edition EN IEC 60601 1 1998 A1 1991 A2 1995 EN 60601 1 1990 A11 19...

Страница 107: ...cribed Electromagnetic Emissions Table 11 6 Electromagnetic Emissions Guidelines Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 Class B The oximeter is suitable for use in all establishments Harmonic emissions IEC EN 61000 3 2 Class A The oximeter is suitable for use in all establishments Voltage fluctuation flicker emissions IEC EN 61000 3 3 Complies ...

Страница 108: ...environment Surge IEC EN 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differen tial mode 2 kV common mode Mains power quality should be that of a typical commercial and or hospital environment Voltage dips short interruptions and voltage variations on power supply IEC EN 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 5 UT 95 dip in UT for 0 5 cycle Mains power quality should be that of a typ...

Страница 109: ...ation appropriate for the frequency of the transmitter Table 11 8 Recommended Separation Distances Immunity Test IEC EN 60601 1 2 Test Level Compliance Level Electromagnetic Environ ment Guidance Frequency of Transmitter Equation for Separation Distance d Conducted RF IEC EN 61000 4 6 3 Vrms 150 kHz 80 MHz 3 Vrms 150 kHz 80 MHz 150 kHz to 80 MHz Radiated RF IEC EN 61000 4 3 3 V m 80 MHz 800 MHz 3 ...

Страница 110: ...d emission of the monitoring system 11 9 3 Safety Tests Ground Integrity 100 milliohms or less Leakage Current The following tables display the maximum earth and enclosure leakage current allowed as well as patient leakage Table 11 9 Cables and Sensors Item Maximum Length Sensors Pulse oximetry sensor cable 1 6 ft 0 5 m Cables Power cable 10 0 ft 3 0 m Nurse call cable 5 9 ft 1 8 m Pulse oximetry ...

Страница 111: ...al Closed Closed 500 µA 300 µA Single Fault Open Closed 1000 µA Closed Open Normal Reversed Closed Closed 500 µA 300 µA Single Fault Open Closed 1000 µA Closed Open Enclosure Leakage Current Condition AC Line Polarity Neutral Line Cord Power Line Ground IEC 60601 1 ANSI AAMI ES 60601 1 2005 Normal Normal Closed Closed 100 µA Single Fault Open Closed 500 µA Closed Open Normal Reversed Closed Closed...

Страница 112: ...ble IEC 60601 1 ANSI AAMI ES 60601 1 2005 Normal Normal Closed Closed 100 µA Single Fault Open Closed 500 µA Closed Open Normal Reversed Closed Closed 100 µA Single Fault Open Closed 500 µA Closed Open Patient Isolation Risk Current Condition AC Line Polarity Neutral Line Power Line Ground Cable IEC 60601 1 ANSI AAMI ES 60601 1 2005 Single Fault Normal Closed Closed 5000 µA Reversed Closed Closed ...

Страница 113: ...nsors were rotated on digits and brow to provide a balanced study design SpO2 values were continuously recorded from each instrument while inspired oxygen was controlled to produce five steady state plateaus at target saturations of approx imately 98 90 80 70 and 60 Six arterial samples were taken 20 seconds apart at each plateau resulting in a total of approximately 30 samples per sub ject Each a...

Страница 114: ...ian 8 Hispanic 2 African American 1 Asian 0 Age 19 48 Weight 108 250 Skin pigment Very light 2 Olive 5 Dark olive Medium black 3 Extremely dark Blue black 1 Table A 2 SpO2 Accuracy for Nellcor Sensors vs CO oximeters SpO2 Decade MAX A MAX N MAX FAST Data Points Arms Data Points Arms Data Points Arms 60 70 71 3 05 71 2 89 71 2 22 70 80 55 2 35 55 2 32 55 1 28 80 90 48 1 84 48 1 73 48 1 48 90 100 11...

Страница 115: ...cted as expected with no adverse events and no devia tions from the protocol 1 Test Sensor Avg CO oximeter value 70 100 SpO2 2 Avg CO oximeter value 70 100 SpO2 Oximetry board with MAX A sensor Trendline of MAX A sensor Oximetry board with MAX N sensor Trendline of MAX N sensor Oximetry board with MAX FAST sensor Trendline of MAX FAST sensor ...

Страница 116: ... indicate that for a saturation range of 60 80 for SpO2 the acceptance criterion was met for the monitoring system when tested with MAX A MAX N and MAX FAST sensors The pooled results indicate that for a saturation range of 70 1 00 for SpO2 the acceptance criterion was met ...

Страница 117: ...99 Electromagnetic Interference 67 F Feature Nurse call interface 48 SatSeconds Alarm Management 85 Trend data download 49 Fractional Saturation 83 Front Panel 11 12 96 Functional Saturation 83 G Ground Integrity Specification 100 I Indicator AC power 13 Battery charge 13 20 22 Interference 13 Sensor disconnect 13 Sensor message 13 Sensor off 13 Intended Use 10 M Measured Saturation 84 Message Sen...

Страница 118: ...representative 16 Fragile 16 Humidity limitations 16 Keep dry 16 Manufacturer 16 Prescription only 16 Temperature limitations 16 This side up 16 Type BF 16 UL listed 16 T Tabular Trend Data 46 Technical Assistance 6 Transport Altitude 92 Relative humidity 92 Temperature 92 Troubleshooting Technical Assistance 6 W Warning Broken LCD panel 2 Explosion hazard 2 High ambient light conditions 3 Liquid ...

Страница 119: ......

Страница 120: ...rt No 10006048 Rev B A7213 1 07 2012 2012 Covidien Covidien llc 15 Hampshire Street Mansfield MA 02048 USA Covidien Ireland Limited IDA Business Technology Park Tullamore www covidien com T 1 800 NELLCOR ...

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