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Nonin LifeSense LS1-9R, Руководство оператора

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Contents 

Indications for Use ........................................................................................ 1

Warnings ................................................................................................................ 1
Cautions ................................................................................................................. 2

Guide to Symbols .......................................................................................... 5
Introduction.................................................................................................... 6

About LifeSense ..................................................................................................... 6
About Capnometry.................................................................................................. 6
About Pulse Oximetry............................................................................................. 6
Operator Requirements .......................................................................................... 7

Displays and Controls................................................................................... 8

Monitor Front View ................................................................................................. 8
Monitor Rear View ................................................................................................ 14
Monitor Right Side View ....................................................................................... 15

Using the LifeSense Monitor ...................................................................... 16

Stationary Operation............................................................................................. 16
Battery Operation ................................................................................................. 16
Mounting............................................................................................................... 17
Pulse Oximeter Sensor......................................................................................... 17

Intended Use..................................................................................................... 17
Applying the Sensor.......................................................................................... 17

Sample Line.......................................................................................................... 18

Intended Use..................................................................................................... 18
Applying the Sample Line ................................................................................. 18

Nafion Tubing ....................................................................................................... 19

Attaching the Nafion Tubing.............................................................................. 19

Single-Patient Use, Disposable Moisture Trap and Filters ................................... 19

Replacing the Moisture Trap/Filter .................................................................... 19

Trend Screen........................................................................................................ 20
Getting Started ..................................................................................................... 20

Preparations...................................................................................................... 20
Connect the Patient........................................................................................... 21
Turn on the Monitor........................................................................................... 21
Check the Alarm Limits ..................................................................................... 22
Disconnect the Patient ...................................................................................... 22

Connecting the Device into a Medical System ..................................................... 22

Settings and Alarms .................................................................................... 23

Touch Panel Display............................................................................................. 23
Factory Default Settings ....................................................................................... 23
Alarm Limits.......................................................................................................... 24

Pulse Limits....................................................................................................... 24
SpO

2

 Limits ....................................................................................................... 24

Respiration Limits.............................................................................................. 24

Содержание LifeSense LS1-9R

Страница 1: ...Operator s Manual LifeSense LS1 9R Vital Signs Monitor Capnography Pulse Oximeter English ...

Страница 2: ...tside USA 800 356 8874 USA and Canada Fax 1 763 553 7807 E mail info nonin com Nonin Medical B V Prins Hendriklaan 26 1075 BD Amsterdam Netherlands 31 0 13 79 99 040 Europe Fax 31 0 13 79 99 042 E mail infointl nonin com nonin com References to Nonin in this manual imply Nonin Medical Inc Nonin LifeSense TrendSense Flexi Form FlexiWrap and PureLight are registered trademarks or trademarks of Nonin...

Страница 3: ...Intended Use 17 Applying the Sensor 17 Sample Line 18 Intended Use 18 Applying the Sample Line 18 Nafion Tubing 19 Attaching the Nafion Tubing 19 Single Patient Use Disposable Moisture Trap and Filters 19 Replacing the Moisture Trap Filter 19 Trend Screen 20 Getting Started 20 Preparations 20 Connect the Patient 21 Turn on the Monitor 21 Check the Alarm Limits 22 Disconnect the Patient 22 Connecti...

Страница 4: ...he Sensor 29 Cleaning the Monitor 29 Calibration 29 Recommended Inspections and Functional Check 30 Troubleshooting 32 Fault Messages 32 Troubleshooting 33 Accessories 34 Monitor Accessories 34 Pulse Oximeter Accessories 35 Capnography Accessories 36 Technical Information 37 Operating Environment 37 Storage Environment 37 Power Requirements 37 System Specifications 38 Pulse Oximeter Specifications...

Страница 5: ... Figures Figure 1 Start up Screens 8 Figure 2 Operating Screen 10 Figure 3 Trend Screen 13 Figure 4 Rear View of Monitor 14 Figure 5 Right Side of Monitor 15 Figure 6 Replacing the Moisture Trap Filter 20 ...

Страница 6: ...atures and Descriptions 14 Table 5 Right Side Components and Descriptions 15 Table 6 Factory Default Settings 23 Table 7 High Priority Alarm Parameters and Causes 26 Table 8 Low Priority Alarm Parameters and Causes 27 Table 9 Electromagnetic Emissions 41 Table 10 Electromagnetic Immunity 42 Table 11 Guidance and Manufacturer s Declaration Electromagnetic Immunity 43 Table 12 Recommended Separation...

Страница 7: ...ximeter sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity Patient sensitivity to sensors and or adhesive strips may vary due to medical status or skin condition Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor Never allow liquids to enter into or to be spilled onto the monitor If ...

Страница 8: ...eep is heard each time a button is pressed If a beep is not heard do not use the device The speaker may not be functioning properly Cautions LifeSense should only be operated by trained licensed practitioners To prevent damage to the monitor operate and store the monitor in an upright position Setting alarm limits to extremes can render the alarm system useless Secure LifeSense with mounting hardw...

Страница 9: ...city before storing it in order to prevent damage to the equipment Avoid rapid temperature change or extreme temperatures This can cause malfunction Never store or transport LifeSense where condensation can occur However if this has occurred wait until all condensation has evaporated before using LifeSense Do not attempt to replace the battery inside the monitor The battery is not field replaceabl...

Страница 10: ...sampling tube may cause erroneous CO2 readings Ensure that all connections are tight leak free and properly attached If the Nafion tubing becomes contaminated or damaged during use discard it and replace it with a new one Radios and cell phones or similar devices may affect the LifeSense and should be kept at least 2 5 meters 8 feet away from the device Field strengths from fixed transmitters such...

Страница 11: ...0529 UL Mark for Canada and the United States with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 and CAN CSA C22 2 No 601 1 Manufacturer ON OFF Audible Alarm Pause Resume Charging indicator This indicator is green when the monitor is connected to a power outlet DC input Used for connecting the power supply l O l O l Serial interface for use with either Tr...

Страница 12: ...ery status and fault messages The only buttons on the monitor ON OFF and Audible Alarm Pause Resume are located on the upper right corner of the front panel Next to these buttons there is a small indicator that turns green when the monitor is connected to a power outlet LifeSense operates on battery power for approximately 8 hours About Capnometry The monitor uses sidestream non dispersive infrare...

Страница 13: ...7 Operator Requirements The LifeSense monitor is easy to operate Each operator should read this manual before using the monitor LifeSense should only be operated by licensed practitioners ...

Страница 14: ...or information on optional accessories All operator settings are adjusted using the touch panel display on the monitor Monitor Front View When the monitor is turned on it displays the start up screens figure 1 and table 1 and then the operating figure 2 and table 2 and trend figure 3 and table 3 screens The following section describes the icons on these screens as well as their functions Figure 1 ...

Страница 15: ...e default alarm limits for patients weighing 30 kg 66 lbs or less Only available if Audible Alarm Enable icon is chosen on previous screen 4 30kg 66lbs Pressing this icon selects the default alarm limits for patients weighing more than 30 kg 66 lbs Only available if Audible Alarm Enable icon is chosen on previous screen 5 LifeSense Version Shows LifeSense version If an error occurs during start up...

Страница 16: ...e 2 Limit Settings The upper figures represent the highest value set by the operator The lower figures represent the lowest value set When the parameter readings fall between the low and high settings they are treated as normal values Values outside these limits activate both audible and visual alarms The limit that triggered the alarm flashes on the display 3 Up Down Bar Control buttons for incre...

Страница 17: ...arms for 2 minutes unless the operator presses the button again This button does not disable the visual alarms The current alarm status displays on the LCD see 13 below 6 ON OFF This button turns the monitor ON or OFF Press the button for more than 1 second to turn the monitor off Briefly pressing this button will also enable or disable the audible pulse beep function NOTE When enabled the audible...

Страница 18: ... screen The trend screen remains visible until an alarm activates or until the operator touches the screen NOTE When an alarm is active this icon does not display on the monitor and the trend screen cannot be accessed 15 Pulse Oximetry Plethysmograph Displays a graph giving information on the oximetry signal plethysmograph The signal displays 25 samples per second 16 Plethysmograph Scale Factor Di...

Страница 19: ...a trend graph of the respiration rate This scale is fixed and cannot be changed 4 Trend ETCO2 Displays a trend graph of the EtCO2 values This scale is fixed and cannot be changed 5 Trend Cursor A trend cursor points out where the actual sample is in the time interval 6 Trend Timescale Timescale is presented in half hour segments 7 Trend Time The total trend time is approximately 4 hours of volatil...

Страница 20: ... is removed guide marks numbered 1 and 2 and arrows are visible on the back of the monitor These guide marks help the user insert the moisture trap 1 Slide the moisture trap into position 2 Press it down Push tab out to remove 2 Attachment Holes Dedicated holes for attaching a mounting bracket See Accessories if a mounting bracket is required 2 mm screws can be used if there is a need to attach th...

Страница 21: ... Call Accessory to add nurse call functionality 2 DC Input Used to connect the power supply to the monitor Only use Nonin specified power supplies 3 SpO2 Connector NONIN Sp02 Used to connect the PureLight pulse oximeter sensor to the monitor See Accessories for a list of pulse oximeter sensors No other sensors may be used WARNING To avoid patient injury use only Nonin branded PureLight pulse oxime...

Страница 22: ...e monitor in a position so the display can be clearly seen 2 Turn LifeSense monitor on by pressing the ON OFF button until you hear a beep The battery symbol on the touch panel display shows the battery capacity 3 Plug the LifeSense power supply into the power outlet as soon as there is no need for battery operation CAUTION To prevent damage to the monitor operate and store the monitor in an uprig...

Страница 23: ... their packaging 1 Choose the appropriate sensor for the patient that will be monitored 2 Remove nail polish or artificial fingernails if applicable 3 Insert a finger into the sensor until the end of the finger reaches the finger stop Keep the fingernail facing the sensor top Ensure long fingernails do not interfere with proper finger position 4 Position the sensor so the cable lies on top of the ...

Страница 24: ...G Misuse or improper handling of the pulse oximeter sensor could damage the sensor or the cable which may lead to inaccurate readings Never alter or modify the sensor since this may affect the performance or accuracy WARNING Inspect the pulse oximeter sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity Patient sensitivity to sensors and or adhe...

Страница 25: ... moisture traps and filters within easy reach When the moisture trap is removed guide marks numbered 1 and 2 and arrows are visible on the back of the monitor These guide marks help the operator insert the moisture trap Replacing the Moisture Trap Filter 1 Place the filter in the moisture trap as shown in figure 6 1 2 Slide the moisture trap into position figure 6 2 using the guide marks on the ba...

Страница 26: ...screen is displayed the trend screen closes and the display returns to the operating screen so the alarm condition is visible To exit the trend screen manually press anywhere on the touch panel display All trend data clears when the device is turned off Getting Started Preparations Visually inspect the monitor and make sure it has no visible signs of damage Examine the SpO2 sensor for obvious defe...

Страница 27: ...Sensor or refer to the individual sensor Instructions for Use Attach the sample line to the patient as described in Applying the Sample Line or refer to the individual sample line Instructions for Use Turn on the Monitor Turn on the monitor by pressing the ON OFF button until you hear a beep The monitor starts by running a self test this only takes a few seconds before the graphs and settings are ...

Страница 28: ...nges to the medical system after device integration could introduce new risks and will require additional analysis Changes to the medical system that must be evaluated include Changing the system configuration Adding devices to or disconnecting devices from the system Updating or upgrading equipment connected to the system Issues resulting from user initiated system changes may include corruption ...

Страница 29: ... SpO2 upper limit 100 95 SpO2 lower limit 85 85 ETCO2 upper limit 7 5 kPa or 57 mmHg 7 5 kPa or 57 mmHg ETCO2 lower limit 1 5 kPa or 13 mmHg 1 5 kPa or 13 mmHg RR upper limit 28 respirations per minute RPM 80 RPM RR lower limit 6 RPM 20 RPM WARNING Verify all alarm settings and limits during system startup to ensure that they are set as intended CAUTION Setting alarm limits to extremes can render ...

Страница 30: ... used to increase an alarm limit The down arrow on the left side of a displayed parameter bar is used to decrease an alarm limit Each time the arrow is pressed it increases or decreases the alarm limit by a single digit until the maximum or minimum is reached The display scrolls through the values if the arrow is steadily pressed Upper limit 255 BPM Lower limit 0 BPM Upper limit 100 Lower limit 0 ...

Страница 31: ...or a message and audible beeping tones at different intervals If an alarm activates when the trend screen is displayed the monitor returns to the operating screen When an alarm is active the trend screen cannot be accessed Alarm Silence There are three categories of LifeSense alarms pulse oximetry capnography and system Audible alarms can be temporarily disabled using the Audible Alarm Pause Resum...

Страница 32: ...rease the alarm limit settings for individual patients If lower alarm limits are set to 0 for the capnograph and for the pulse oximeter alarms are disabled until the limits are set higher The Alarm Disabled icon appears on the touch panel display High Priority Alarm A high priority alarm calls for immediate action from the operator An alarm table 7 occurs if any of the parameters are outside the o...

Страница 33: ...Alarm Disable on the start up screen or by decreasing all lower limit settings to 0 When audible alarms are disabled the Alarm Disabled icon displays on the touch panel display Table 8 Low Priority Alarm Parameters and Causes Parameter Message Possible Cause Pulse oximetry NO PROBE Sensor is not connected to the monitor Pulse oximetry NO FINGER Sensor is not connected to the finger Pulse oximetry ...

Страница 34: ...ery symbol indicating battery capacity Approximate battery capacity is defined by the battery symbols below A filled battery symbol indicates the monitor can be used for approximately 8 hours A depleted battery symbol indicates the battery has run out of power and needs recharging immediately To check the battery s capacity time how long a fully charged battery is able to power the device When a f...

Страница 35: ...erification gas are available from Nonin see Accessories Please contact Nonin Technical Services if monitor maintenance cannot be performed at your facility Cleaning the Sensor Refer to individual sensor Instructions for Use for details Cleaning the Monitor Clean the monitor with a soft cloth moistened with isopropyl alcohol Allow the monitor to dry completely after cleaning Calibration LifeSense ...

Страница 36: ...se The T connector allows excess flow to exit into the room b Verify that the gas valve needle is in the green zone of the dial indicator If the gas valve needle is in the red zone the CO2 tank is empty and should be replaced c Release gas for 4 5 seconds until the ball rises to the top of the column and then turn off the gas valve This equals one exhale The ball should return to the bottom of the...

Страница 37: ...ero point of the CO2 graph is not elevated WARNING If the LifeSense fails to respond as described discontinue use and contact Nonin Technical Service CAUTION LifeSense should only be operated by trained licensed practitioners WARNING Never allow liquids to enter into or to be spilled onto the monitor If liquid has penetrated into the monitor it must be checked by Nonin Technical Service CAUTION Be...

Страница 38: ...nected to the moisture trap Verify connection to moisture trap NO PROBE The sensor is not connected to the monitor Check all sensor connections between patient and the monitor NO FINGER The sensor is not connected to the patient or the sensor is damaged Check sensor application site ARTIFACT A detected pulse beat did not match the detected pulse interval Check the sensor application site Reapply s...

Страница 39: ... status It is also possible to get a low reading if an air leakage has occurred in the sample line Nafion tubing moisture trap or internally Check patient status Check the moisture trap and filter Replace the moisture trap and filter if necessary Check sample line connector and visually inspect the sample line for signs of damage Check Nafion tubing connection If the problem persists contact Nonin...

Страница 40: ...2 0 in diameter poles TrendSense TrendSense W Data memory modules Dimensions 38x32x17mm The module does not contain a battery it draws power from the host PC software and cable included TrendSense logs EtCO2 respiration rate pulse and oxygen saturation once per second for more than 72 hours TrendSense W logs EtCO2 respiration rate pulse and oxygen saturation four times per second for up to 36 hour...

Страница 41: ...placeable adhesive FlexiWrap Optimal performance in motion situations Comfortable for extended monitoring Durable and easy to clean Adult Flex Sensor 20 kg 44 lb for fingers Infant Flex Sensor 2 20 kg 4 4 44 lb Adult FlexiWrap Pack of 25 for index middle or ring finger Infant FlexiWrap Pack of 25 for toe thumb hand 6000CA 6000CP 6000CI PureLight Value Line Sensor Single Use Ideal for extended moni...

Страница 42: ...ds Straight T Connector Single use disposable gas sampling port 15 and 22 mm connector ends For use with CO2 sample line to connect monitor to a main stream PermaPure Nafion Tubing Single use disposable Nafion tubing to remove water vapor from the sample line Verification Gas Verification gas and tubing Contains 5 Vol of CO2 equals 38 mmHg or 5 3 kPa To be used with a gas valve Gas Valve for Verif...

Страница 43: ...ted to the serial port of this device must be certified according to at least IEC Standard EN 60950 or UL 1950 for data processing equipment CAUTION Portable and mobile RF communications equipment can affect medical electrical equipment CAUTION If LifeSense is intended to be stored for longer periods of time always charge the battery to full capacity before storing it in order to prevent damage to...

Страница 44: ... to 104 F 5 C to 40 C Device temperature will not exceed 41 C as measured during a controlled environment test Humidity 10 to 90 non condensing Atmospheric Pressure 720 to 1060 hPa 540 to 795 mmHg Altitude Up to 9 000 ft 2 740 m Storage Temperature 40 F to 158 F 40 C to 70 C Humidity 10 to 90 non condensing Pump Pump Flow 75 ml min Flow Accuracy 15 ml min Alarms Sound Pressure Level 65 dBa maximum...

Страница 45: ...gen SaO2 value determined from blood samples with a laboratory co oximeter The accuracy of the sensors in comparison to the co oximeter samples measured over the SpO2 range of 70 100 Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 80601 2 61 Standard Specification for Pulse Oximeters for Accuracy Displayed Oxygen Saturation Range SpO2 0 to 100 Displayed ...

Страница 46: ... 2 kPa 2 mmHg 8 of reading 540 795 mmHg EtCO2 CO2 reading reaches its steady state accuracy 10 minutes after power up Update Frequency Once every breath No Breath alarm after 25 seconds Sampling Rate 4 Hz 4 times per second Total System Response Time 4 seconds includes delay time and rise time Drift of Measurement Within CO2 accuracy specifications for 6 hours of continuous monitoring Measurement ...

Страница 47: ...is used in such an environment RF Emissions CISPR 11 Group 1 This device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B This device is suitable for use in all establishments including domestic and those directly connected to the public low voltage power s...

Страница 48: ... differential mode 2 kV for common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 cycles 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT...

Страница 49: ...han the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 Professional Transport 20 V m 80 AM 1 kHz modulation 80 MHz to 2 5 GHz 20 V m Notes At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absor...

Страница 50: ...Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the t...

Страница 51: ...se Rate 75 BPM Specific to this example the response of the 4 beat average is 1 5 seconds SpO2 Values Average Latency Standard Fast Averaged SpO2 4 beat exponential 2 beats Pulse Rate Values Average Latency Standard Fast Averaged Pulse Rate 4 beat exponential 2 beats Equipment Delays Delays Display Update Delay 1 5 seconds Alarm Signal Generation Delay 0 seconds CAUTION A functional tester cannot ...

Страница 52: ...by the purchaser by serial number that there is a defect provided said notification occurs within the applicable warranty period This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any LifeSense delivered to the purchaser which is found to be defective in any manner whether such remedies be in contract tort or by law This warranty excludes cost of delivery to and fr...

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