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149

Electromagnetic Compatibility

Changes or modifications to this system not expressly approved by GE can cause EMC issues with this or other equipment. This system is
designed and tested to comply with applicable regulation regarding EMC and must be installed and put into service according to the EMC
information stated in this section.

Guidance and manufacturer’s declaration – electromagnetic emissions

Guidance and manufacturer’s declaration – electromagnetic emissions

The monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the monitor
should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

The monitor 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 A

The monitor is suitable for use in all establishments other than domestic
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.

Hermonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Complies

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Summary of Contents for B20

Page 1: ...B40 B20 Patient Monitor User s Guide English 2081499 002 E Paper 21 November 2014 2014 General Electric Company All rights reserved ...

Page 2: ......

Page 3: ...Copyright 2014 General Electric Company All rights reserved GE Medical Systems Information Technologies Inc 8200 West Tower Avenue Milwaukee WI USA Zip 53223 Tel 1 414 355 5000 outside US 800 558 5102 US only Fax 1 414 355 3790 www gehealthcare com GE Healthcare 3F Building 1 GE Technology Park 1 Huatuo Road Shanghai PRC 201203 Tel 86 21 3877 7888 Fax 86 21 3877 7451 ...

Page 4: ...ds and Snapshot 51 Printing and recording 55 Cleaning and care 59 ECG 67 Pacemaker detection 73 Arrhythmia detection 75 ST Detection 77 Impedance respiration 79 Pulse oximetry SpO2 83 Non invasive blood pressure NIBP 89 Invasive blood pressure 95 Temperature 101 Airway gas 103 Entropy 115 Troubleshooting 121 Messages 124 Abbreviations 129 Technical specifications 135 Electromagnetic Compatibility ...

Page 5: ...eans choosing and confirming Messages alarm messages informative messages displayed on the screen are written inside single quotes Learning Note statements provide application tips or other useful information Monitor naming conventions In this manual the B40 Patient Monitor and B20 Patient Monitor are referred to as the monitor when a function or a feature applies to both For describing monitor sp...

Page 6: ...nd servicing B40 B20 Patient Monitor Technical Reference Manual Options and selections of the software B40 B20 Patient Monitor Default Configuration Worksheet Compatible supplies and accessories B40 B20 Patient Monitor Supplies and Accessories Other devices closely related to the monitor iCentral and iCentral Client User s Reference Manual CIC Pro Clinical Information Center Operator s Manual CARE...

Page 7: ...erature impedance respiration respiration rate airway gases CO2 O2 N2O anesthetic agents anesthetic agent identification and respiratory rate and Entropy Indications for use B20 This device is a portable multi parameter unit to be used for monitoring and recording of and to generate alarms for multiple physiological parameters of adult pediatric and neonatal patients in a hospital environment and ...

Page 8: ...im Knob Unity Network CARESCAPE EK Pro TruSignal Entropy GE Healthcare GE Medical system General Electric Company Responsibility of the manufacturer GE Medical Systems Information Technologies Inc is responsible for the safety reliability and performance of the equipment only if Assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by GE The el...

Page 9: ...ith CISPR 11 Group 1 Class A Group 1 contains all ISM Industrial scientific and medical equipment in which there is intentionally generated and or used conductively coupled radio frequency energy which is necessary for the internal functioning of the equipment itself Class A equipment is equipment suitable for use in all establishments other than domestic and those directly connected to a low volt...

Page 10: ...itor conforms to particular safety standard for multifunction patient monitoring equipment to IEC 60601 2 49 The invasive blood pressure parameter conforms to the IEC 60601 2 34 The ECG parameter conforms to IEC 60601 2 27 with exception of Sub clause 201 12 1 101 15 The NIBP parameter conforms to IEC 80601 2 30 EN 1060 3 ANSI AAMI ISO 81060 2 The Entropy parameter conforms to IEC 60601 2 26 The a...

Page 11: ...erformance and cause a malfunction as a result of the product being physically damaged due to cleaning disinfection re sterilization and or reuse There are hazards associated with the reuse of single use sample tubing and adapters Inspect the sensor for signs of physical damage Discard a damaged sensor immediately Never repair a damaged sensor never use a sensor repaired by others Do not sterilize...

Page 12: ...onsibility of the hospital Don t modify this device without authorization of manufacturer If this device is modified appropriate inspection and testing must be conducted to ensure continued safe use of equipment Caution safety messages The following caution safety messages apply to this monitoring system U S Federal law restricts this device to sale by or on the order of a physician SUPERVISED USE...

Page 13: ...informed experts for proper use In all cases safe and proper operation should be verified with the applicable manufacturer s instructions for use and system standards IEC 60601 1 must be complied with The medical electrical equipment or medical electrical system may be interfered with by other equipment even if that other equipment complies with CISPR EMISSION requirements BEFORE INSTALLATION Comp...

Page 14: ... view 1 Transportation handle 2 Alarm light 3 Trim knob 4 Command board keys 5 Battery compartment 6 Guide rail for GCX mounting 7 Mains power and battery LEDs 8 On Off key 9 Hemo connectors 10 E module 11 Recorder module 10 1 2 3 4 5 6 8 7 9 11 ...

Page 15: ...rs B40 back view B20 back view 1 Receptacle for power cord 2 Serial port 3 Defibrillator connector 4 Nurse call connector 5 Network connector 6 Equipotential connector 7 Multi I O connector NOTE 2 3 4 is on the multiple Input Output adapter 4 7 1 6 5 3 2 ...

Page 16: ...12 Acquisition modules B40 acquisition modules E miniC E sCO E sCAiO N CAiO E Entropy B20 acquisition modules E miniC E Entropy E miniC module 1 Water trap 2 Sample gas inlet 3 Gas outlet 1 2 3 ...

Page 17: ...ling line connector sampling gas in 3 Water trap container 4 Gas exhaust line connector sampling gas out N CAiO module 1 D fend Pro water trap 2 Gas sampling line connector sampling gas in 3 Water trap container 4 Gas exhaust line connector sampling gas out 1 2 3 4 1 2 3 4 ...

Page 18: ...14 E Entropy module 1 Module keys 2 Entropy connector 1 2 ...

Page 19: ...re Identifier ECG NIBP SpO2 IBP Temperature Hemo with GE SpO2 X X GE SpO2 X X SpO2_IBP_T Hemo with Masimo SpO2 X X Masimo SpO2 X X MasimoSpO2_IBP_T Hemo with Nellcor SpO2 X X Nellcor SpO2 X X NellcorSpO2_IBP_T Hemo with GE SpO2 without IBP X X GE SpO2 X SpO2_T Hemo with Masimo SpO2 without IBP X X Masimo SpO2 X MasimoSpO2_T Hemo with Nellcor SpO2 without IBP X X Nellcor SpO2 X NellcorSpO2_T Hemo w...

Page 20: ...t or stop NIBP auto cycling 9 Reset active alarms 10 Audio pause active alarms 11 Return to normal screen view 12 Start or stop local recording NOTE Functional only when recorder option is available 13 Start or stop the NIBP manual measurement 14 Take up to 10 snapshots see Take snapshots on page 53 15 Activate the Alarms Setup menu 16 View historical trends and alarm events 16 3 4 9 8 7 5 1 6 2a ...

Page 21: ... against electric shock Isolated floating applied part suitable for intentional external and internal application to the patient excluding direct cardiac application Type BF IEC 60601 1 defibrillator proof protection against electric shock Isolated floating applied part suitable for intentional external and internal application to the patient excluding direct cardiac application Type CF IEC 60601 ...

Page 22: ...rmal screen view ON OFF Fuse Gas inlet Gas outlet IP21 Degree of ingress protection Degree of protection against harmful ingress of water Components not marked with and IPX n code are rated as Ordinary no protection against fluid ingress All other IPXn rated components have the degree of protection per the n rating SN S N Serial number Date of manufacture This symbol indicates the date of manufact...

Page 23: ...by or on the order of a Physician or persons licensed by state law Fragile Handle with care Keep dry Protect from rain This way up Storage temperature Humidity limitations C US 3ZG9 Atmospheric pressure limitations Recycled materials or may be recycled Battery operation and remaining capacity The height of the green bar indicates the charging level Battery A charging white bar Battery A failure No...

Page 24: ...a battery or its packaging to advise you that the battery must be recycled or disposed of in accordance with local or country laws To minimize potential effects on the environment and human health it is important that all marked batteries that you remove from the product are properly recycled or disposed For information on how the battery may be safely removed from the device please consult the se...

Page 25: ...of frame enclosure in normal use Cautions Do not drop battery or subject to mechanical shock Use only the recommended batteries Malfunction may cause gases to vent SAFETY GROUND PRECAUTION Remove power cord from the mains source by grasping the plug DO NOT pull on the cable Inserting and removing acquisition modules To use the acquisition module your monitoring device need to be pre configured wit...

Page 26: ...ges in the user mode Please refer to Chapter Setting up the monitor before use for more details Using menus A menu is a list of functions or commands To display a menu press one of the keypad keys To select menu options with Trim Knob control 1 Rotate the Trim Knob control in either direction to move the highlighted cursor from option to option on the display 2 Press the Trim Knob control once to ...

Page 27: ... with Aware Gateway Server v1 6 compatible with CARESCAPE Gateway server v1 compatible with Mobile Care Server v6 0 compatible with S 5 Collect v4 0 On the CARESCAPE network the bedside monitor can simultaneously communicate with a maximum of 4 central stations 1 Gateway server 1 Mobile Care Server and up to 1 000 other monitoring devices The bedside monitor cannot be the Time Master on the CARESC...

Page 28: ...y Entropy alarm limits OR Displays up to 24 hours of trend data Connection to Network Ensure that the appropriate network infrastructure is in place prior to the installation of the patient monitor NOTE The network installation and configuration are performed by authorized service personnel only MC and S 5 Network Use the CAT 5 network cable to connect the monitor to the network 1 Make sure that t...

Page 29: ... frame LEDs indicate the current charging level and any possible failures You can check the battery status through Monitor Setup Battery Setup For additional information please refer to the table following this statement The battery should be used if the integrity of the PROTECTIVE EARTH CONDUCTOR in the installation is in doubt To configure to have the battery charge status visible at all time fo...

Page 30: ...on Front panel battery LEDs Monitor is battery powered Batteries are fully charged the size of the green bar indicates the charging level Orange dark Green lit Monitor is battery powered Battery A is empty battery B charge is partially charged Orange dark Green lit Monitor is battery powered Battery A failure battery B is full Orange flashing Green lit NOTE If both batteries fail the green battery...

Page 31: ...ke sure to close the battery compartment by sliding the lid back to the right until it clicks 1 Open the cover of the battery compartment located on the side of the monitor Move the latch up or down Remove the desired battery 2 Insert the new battery Ensure that the battery charging indicator is facing to the back side of the monitor then push the battery in all the way move the latch to the middl...

Page 32: ...see Conditioning the batteries and the User s Reference Manual The monitor does not start Check that the batteries are properly inserted and sufficiently charged see page 25 Check that the power cord is properly connected Check the fuses and replace them if necessary see Cleaning and care ...

Page 33: ...onfigured page is called the normal screen Any changes made to the screen setup during active monitoring are temporary unless saved to a profile All temporary changes will be discarded when the case ends or when the monitor is discharged NOTE The temporary settings are retained in the monitor s memory for 15 minutes after the power is turned off Changing waveform fields 1 Press the Monitor Setup k...

Page 34: ...lect Screen Setup 2 Select Digit Fields and change the field contents NOTE Depending on your configuration if the same measurement in the digit field that is currently in the waveform field the waveform field disappears If a digit field is turned OFF the remaining digit fields are enlarged to fill the space Changing split screen To configure the normal screen to display both real time data and Min...

Page 35: ...es better than sweep speeds set to Fast 1 Press the Monitor Setup key 2 Select Sweep Speeds 3 Select the parameter and adjust the value Parameter colors Parameter color options include yellow white green red blue orange and violet To change the color perform the following steps 1 Press the Monitor Setup key 2 Select Install Service and enter the password 3 Select Colors 4 Select the desired parame...

Page 36: ...through Admit Discharge Select Mode NOTE You need select patient type to NEO through Admit Discharge first if you want to select NEONATAL mode 2 Make necessary changes sweep speeds parameter colors report contents screen setup trends etc To change a parameter setup press a parameter key and go to the setup menu For instructions see relevant parameter sections To change alarm limits and volume pres...

Page 37: ...ettings 1 Press Monitor Setup key 2 Select Install Service and enter the password 3 Select Trends Snapshot 4 Select Snapshot Field 1 Field 6 Select to display waveform graphical trend or numerical trend Field 1 5 can be displayed on screen and Field 6 can be printed Create on Alarms Select YES default to create automatic snapshots for Tachy Brady Art high Art low alarms NOTE If you need arrhythmia...

Page 38: ...date Battery setup Through this menu you can check the battery status 1 Press the Monitor Setup key 2 Select Battery Setup Battery information is now available Changing the monitor installation settings Changing unit You can change units for height weight and blood pressure 1 Press Monitor Setup key 2 Select Install Service and enter the password 3 Select Installation Units 4 Set the units for hei...

Page 39: ...me of audible alarm tone Reminder Volume Adjust volume of audible alarm reminder tone Alarm Tones Select ISO ISO2 General or IEC tones Remote Control Select active to enable alarm remote control by central station Inactive is the default Changing the printer settings 1 Press Monitor Setup key 2 Select Install Service and enter the password 3 Select Installation Printer Snapshot Printout Select 12 ...

Page 40: ...ync options Unity is time sync to Unity Network NTP is time sync to NTP Server NTP Config to set NTP Server configuration GMT Offset Hours to set offset hours from GMT Greenwich Mean Time GMT Offset Minutes to set offset minutes from GMT Primary Server IP to set primary NTP Server IP address Secondary Serv IP to set secondary NTP Server IP address NOTES DST Offset Hour and DST Offset Minute menu a...

Page 41: ...lance with correct operation of monitoring equipment After connecting the monitor to the central station and or nurse call system verify the function of the alarm system The functions of the alarm system for monitoring of the patient must be verified at regular intervals Make sure alarms are active and set according to patient condition Only the latest and highest priority alarm is sent to CARESCA...

Page 42: ...he alarm level 5 High and medium priority physiological alarms medium priority technical alarms will be stored in alarm history NOTE If the monitor is connected to the network it also sends alarms to the central station NOTE If the monitor is connected to the nurse call system the high and medium priority alarms will trigger the nurse call system NOTE If the alarms are off on the monitor the alarm...

Page 43: ...t in Message Field Solid red background with audio pause symbol Yellow boundary blue gray background with audio pause symbol Cyan boundary blue gray background with audio pause symbol No Physiological data values in Digit Field Flashing red physiological alarms only Flashing yellow physiological alarms only No No Alarm light Flashing red Flashing yellow Solid Cyan No Alarm tone ISO pattern 10 beep...

Page 44: ...ult Configuration Worksheet Two or more alarms of equal priority are ranked according to the generated time The latest alarm displays on the left Alarm priority escalation An escalating alarm starts at a designated priority level low or medium and will escalate to the next higher priority level of alarm after a set number of seconds if the alarm condition has not been resolved It is important to n...

Page 45: ...he digit field with the correct color An alarm printout if enabled 3 Audio pause the alarms and confirm that the alarms are paused and that the left side of the alarm indicator light is a correct color 4 Return the parameter alarm limit to the original value Parameter Physiological alarm activation criteria ECG Active measurement for 30 seconds Impedance respiration Active measurement for 30 secon...

Page 46: ... monitored parameters based upon the current physiological value 1 Select Alarms Setup from the monitor s main menu 2 Select Auto Limits Limits are calculated from the displayed patient reading at the point of time when auto limits are selected Returning alarm limits to their default settings 1 Select Alarms Setup from the monitor s main menu 2 Select Default Limits The factory default alarm limit...

Page 47: ...te EtCO2 and FiCO2 limit alarms except the related technical alarms Silence ECG Turns off audible alarms for all HR source ECG Art and Pleth limit and arrhythmia alarms except the related technical alarms Silence Apn ECG Turns off audible alarms for apnea respiration rate EtCO2 FiCO2 all HR source limit and arrhythmia alarms except the related technical alarms Silence ALL Turns off all audible ala...

Page 48: ...alarms for example V Tach See the Default configuration worksheet for details about breakthrough alarm Cease all latched alarms including message and light Alarm light Yes Alarm message Yes and has the audio pause countdown icon Alarm audio No except breakthrough alarms Press audio pause key second time during audio paused period Cease the audio pause state Remove alarms listed below Alarm light Y...

Page 49: ... array overheat No battery backup Showing alarm history 1 Press the Pt Data Trends key 2 Select Alarm History a list of the last 20 alarms are displayed for 24 hours Latched Alarms When alarms are latched the alarm messages stay on the screen even if the initial alarm condition goes away You will also hear a reminder beep every 10 seconds To clear the message field of the no longer active alarm me...

Page 50: ...dio Off or a 2 minute alarm audio pause condition See Changing alarm options in Setting up the monitor before use chapter for how to turn on off breakthrough alarms feature See the Default configuration worksheet delivered with the monitor for details of which alarms and conditions are enable for breakthrough feature ...

Page 51: ...ting monitoring 1 Prepare the patient connections according to the setup picture in the measurement section Use only approved supplies and accessories see the Supplies and Accessories catalog The alarms and parameter settings become active 2 Enter or load patient data by pressing the Admit Discharge key according to the instructions given later in this chapter 3 Start the measurement according to ...

Page 52: ...iefly in Modifying the screen setup NOTE Changing the mode also changes settings such as the alarm limits For the details of factory default settings see the Default Configuration Worksheet The monitor automatically reconfigures the display when module are inserted Reconfiguration of the display may take up to five seconds Loading patient data If the patient has already been admitted on the same m...

Page 53: ...guration Ending monitoring 1 Print necessary data press the Print Record key 2 Wait until the printing is finished Then clear the patient data and return the settings including alarm limits to their defaults through Admit Discharge Discharge YES 3 Turn off the monitor from the ON OFF key if the monitor will not be used NOTE A message Monitor is shutting down will be on the screen 4 Clean the monit...

Page 54: ...for the use of training and demo of operation It is not intended for clinical use or patient monitoring and diagnosis The Demo Mode menu is under service menu of the monitor it s need password to enter Please consult the qualified service personnel to open and close the Demo Mode Troubleshooting The measured values are not displayed Check that you have selected the desired parameter to a waveform ...

Page 55: ...waveform data from realtime graph strips Trends view 1 Measurement trend field 2 Real time ECG 3 Numerical value of a measurement at the trend cursor point 4 Time and marker field 5 Trend page number Symbols Trend bar the gap shows the blood pressure mean value NIBP trend bar Indicator of change for example ST relearning or zeroing of an invasive blood pressure channel changing a label ...

Page 56: ...varies from 20 minutes to 72 hours With the 20 minute trend length the displayed time period is 30 minutes and the resolution 10 seconds With trend lengths from one to 72 hours the displayed time period is 72 hours and the resolution is one minute To print graphical trends 1 Press the Pt Data Trends key 2 Select Trends Graphical 3 Select Print Page NOTE Network laser printer only Viewing and print...

Page 57: ...ing snapshots To view snapshots 1 Press the Pt Data Trends key 2 Select Trends Snapshot Next Snapshot Turn the Trim knob to move to the next snapshot In the waveform field you can see the time the snapshot was created Five fields can be displayed on the snapshot page and six fields can be printed In the trend field the graphical trend view or the numerical trends view are displayed according to th...

Page 58: ... Snapshot creation To display the OCRG snapshot record 1 In NEONATAL mode press the Pt Data Trends key 2 Select OCRG Snapshots You can select Scroll Snapshots and scroll left and right with the Trim Knob to see the earlier OCRG snapshots The trigger time and condition also showed on the left menu area You can select Remove Menu to hide the left side menu Press the Trim Knob to show the menu View r...

Page 59: ...directly see following instruction Selecting a printer 1 Press the Print Record key 2 Select Printer Connection 3 Select the printer from the list Printing graphical trends To print graphical trends 1 Press the Print Record key 2 Select Print Graphical 3 Setup the printing settings Page X which page of the trends to be printed Hours Page how many hours trends in one page this is used to setting up...

Page 60: ... by following alarms reach the red level Asystole Tachy Brady Art Sys Dia Mean high Art Sys Dia Mean low V Fib V Tach Delay record from 12 seconds prior the events or record from current time Paper Speed set up the paper speed to adjust the recorded waveforms more clearly or more generally Length set up the length of the recording 3 To start the recording press the Recorder Start Stop key or Selec...

Page 61: ...select Stop Numerical Recording graphical trends 1 Press the Print Record key select Record Trends 2 Select Graphic Trend 1 or Graphic Trend 2 to set up parameters of graphical trends 3 To start the recording select Record Graphical 4 To stop recording select Stop Graphical Trends are recorded for the time period that corresponds to the time scale of the graphical trends To choose the time scale 1...

Page 62: ...ossible Check the printer setting through Print Record Printer Connection Check that the printer is connected to the network Check the network cable Recording is not possible Check the Central recorder if you are recording through network ...

Page 63: ...SENSOR AFTER CARE Do not immerse sensors or patient cables in water solvents or cleaning solutions Do not reuse sensors intended for single patient use Do not sterilize sensors or patient cables by irradiation steam or ethylene oxide Clean the surface of the probe before and after each patient use Allow sensor and cable to dry completely after cleaning Moisture and dirt on the connector can affect...

Page 64: ...companying the accessory Daily and between patient Wipe the monitor and module surfaces with permitted cleaning agents Wipe the ECG trunk cable NIBP cuff and cables and SpO2 sensors with permitted cleaning agents Avoid excessive use of liquids Change or sterilize all airway and other invasive patient accessories Clean disinfect or sterilize reusable temperature probes Empty the water trap Use a ne...

Page 65: ...or 2 Disconnect the power cord 3 Remove all cables and batteries if applicable and close battery door s 4 Use a soft lint free cloth with one of permitted cleaning agents to wipe the exterior surface 5 Wipe off the cleaning solutions with a clean lightly moistened cloth 6 Dry thoroughly with a dry lint free cloth and let air dry for at least 30 minutes 7 Reconnect the power cord 8 Turn on the moni...

Page 66: ...mperature sensors catheters pulse oximetry probes and other reusable accessory parts see the manufacturer instructions for cleaning sterilization or disinfecting methods Gas module water trap cleaning instructions Empty the water trap container when it is more than half full With a sample gas temperature of 37 C a room temperature of 23 C and sample gas relative humidity of 100 RH the water trap s...

Page 67: ...eries can be found in the User s Reference Manual Power interruption NOTE Always use the monitor with batteries inserted If the monitor is turned off trend data and the temporary settings are remained for 15 minutes even if the mains power is interrupted After 15 minutes trend data is lost and the monitor returns to the user default settings startup mode Recycling the batteries When the battery no...

Page 68: ...t the acquisition module is connected to the monitor After installing the module check that the message Calibrating gas sensor displays in gas waveform field for about 1 minute Entropy Check that the acquisition module is connected to the monitor After connecting the Entropy sensor cable to the module check that the message No sensor displays Functioning of the alarm Check that the red yellow and ...

Page 69: ...k D Fend and or Check sample gas out Resolve the alarm condition before starting calibration Starting calibration 1 On the monitor select Airway Gas Gas Calibration 2 The monitor will start automatic zeroing the gas sensors Wait until the message Zeroing is replaced by the message Zero OK for all measured gases 3 Open the regulator after the message Feed gas displays for all measured gases The mea...

Page 70: ...ils due to a large gain adjustment NOTE If zeroing or calibration failed select Recalibrate to restart the calibration procedure Checking temperature NIBP and invasive blood pressure calibration Checking temperature NIBP and invasive blood pressures calibration should be performed at least once a year by qualified service personnel as a part of the Planned Maintenance for more information see the ...

Page 71: ...onitor Do not use equipment for positioning floating temporary pacemaker leadwires performing pericardiocentesis or other internal applications HEART RATE ALARM INTERFERENCE Poor cable positioning or improper electrode preparation may cause line isolation monitor transients to resemble actual cardiac waveforms and thus inhibit heart rate alarms To minimize this problem follow proper electrode plac...

Page 72: ...ble lead set and module connectors dry Avoid excessive use of liquids when cleaning cables and connectors NOTE In 5 lead ECG place the 5th electrode C V in one of the six places indicated and select the corresponding V lead label L L R L R A I I I III L A R L R A L A 2 LEAD I LE AD III LEAD II L LA R RA F LL 1 3 R RED IEC RA WHITE AAMI L YELLOW IEC LA BLACK AAMI R RED IEC RA WHITE AAMI L YELLOW IE...

Page 73: ...ad skin cells and oil 4 Dry the skin completely before applying the electrodes NOTE Do not use the electrodes with dissimilar metals Applying the electrodes to the patient 1 Place the electrodes on the prepared sites 2 Stabilize the electrode and leadwire with a leadwire stress loop near the electrode 3 Tape the stress loop to the patient excluding neonates A secured stress loop prevents leadwire ...

Page 74: ... ECG and select ECG2 Lead ECG3 Lead Casc To increase ECG amplitude press ECG and select ECG Size To change the waveform sweep speed press Monitor Setup select Sweep Speeds Hemodynamics and adjust the value NOTE The module input circuits are protected against the effects of electrosurgery and defibrillation However the ECG waveform on the monitor screen may be disturbed during electrosurgery Select...

Page 75: ...at is displayed with heart rate 1 Press the ECG key 2 Select ECG Setup Display with HR and select the appropriate option PR PVC None Displaying the ECG grid 1 Press the ECG key 2 Select ECG Setup Select Grid and select the appropriate option ON To view ECG wavefroms over gridlines OFF To view ECG wavefroms without gridlines Adjusting the beat sound volume 1 Press the ECG key 2 Select ECG Setup Bea...

Page 76: ...72 For your notes ...

Page 77: ...LS False low heart rate indicators or false Asystole calls may result with certain pacemakers because of pacemaker artifact such as electrical overshoot of the pacemaker overlapping the true QRS complexes Monitoring pacemaker patients 1 Press the ECG key 2 Select ECG Setup Pacemaker and select the appropriate option Show Pacemaker spike is displayed on the ECG waveform Sensit Sensitive pacemaker d...

Page 78: ...74 For your notes ...

Page 79: ...entís predominant morphology it is possible for those events remain undetected by the system SUSPENDED ANALYSIS Certain conditions suspend arrhythmia analysis When suspended arrhythmia conditions are not detected and alarms associated with arrhythmias do not occur The messages which alert you to the conditions causing suspended arrhythmia analysis are Arrhythmia Paused Leads off and Patient discha...

Page 80: ...changes considerably the monitor automatically relearns the new ECG pattern To manually relearn the ECG pattern through ECG Relearn Start Selecting arrhythmia alarm for snapshots 1 Press the ECG key 2 Select ECG Alarms Arrh Alarms Adjust 3 Select YES default or NO for each alarm Detecting arrhythmia alarms NOTE Arrhythmia alarms are not to be used for diagnosis A physician must analyze the arrhyth...

Page 81: ... distance between the ST and J point is set according to the heart rate If the heart rate is less than 120 bpm the ST point is set at J 80 ms If the heart rate is more than or equal to 120 bpm the ST point is set at J 60 ms Manually adjusting ST measurement points The J ISO and ST measurement points can also be selected manually If any the measurement points are manually selected the other two mea...

Page 82: ...gorithms of monitor search the J and isoelectric ISO points The system learns the ECG and stores the reference QRST complex The algorithm sets the ISO and J points Due to the large variation with QRST complexes the user has possibility to adjust the ST measurement points manually The QRS analysis classifies each beat by using several criteria and rejects distorted complexes from the ST calculation...

Page 83: ...his use another form of respiration monitoring for instance the E miniC module Electrical interference Electrical devices such as electrosurgery units and infrared heaters that emit electromagnetic disturbance may cause artifacts or disable the respiration measurement completely Movement artifacts Changing position moving the head moving the arms or shivering may result in movement artifacts Also ...

Page 84: ... value the larger the waveform size Selecting the respiration rate source 1 Press the Others key 2 Select Resp Setup Resp Rate Source 3 Select the appropriate option AUTO CO2 Imped NOTE The AUTO selection lets the monitor choose the respiration rate source If CO2 is monitored it is chosen to be used If not then impedance respiration is chosen as the respiration rate source Adjusting the respiratio...

Page 85: ... the Others key 2 Select Resp Setup Resp Rate Alarm To set up the limits select Adjust Limits To OFF ON the limits select RR Alarm 3 You can also select Alarms Setup to adjust RESP or related alarms Troubleshooting Measurement fails Check the electrode quality and positioning Adjust the detection limits During ventilator supported breathing the respiration calculation may count only ventilator pro...

Page 86: ...82 For your notes ...

Page 87: ...t likely to be encountered when the monitor is used on neonates or infants These same conditions in adults do not impact the SpO2 values to the same extent We recommend the application of the following criteria when using the pulse oximetry function on neonates and infants The peripheral pulse rate PPR as determined by the SpO2 function must be within 10 of the heart rate and The SpO2 signal stren...

Page 88: ...hecking probe site every four hours more frequently for poor perfusion or neonate Refer to instructions supplied with sensor Measurement limitations The pulse oximeter cannot distinguish between oxyhemoglobin and dyshemoglobins Poor perfusion may affect the accuracy of measurement when using the ear probe To avoid erroneous readings do not use a blood pressure cuff or arterial blood pressure measu...

Page 89: ...ect cable 3 Reusable sensors 4 Disposable sensors NOTE For a comprehensive list of accessories see the Supplies and Accessories catalog delivered with the monitor NOTE For each SpO2 accessory refer to the instructions for use in the accessory package for patient weight limits 3 1 2 4 ...

Page 90: ...which patient or any other person may come into contact Selecting the SpO2 heart rate The heart rate can originate from various sources Displaying the pulse rate measured with pulse oximetry 1 Press the SpO2 key 2 Select HR Source Pleth NOTE Art ABP UAC is visible when a related label is selected NOTE The AUTO selection priorities for heart rate calculation are ECG the lead with highest R wave pre...

Page 91: ...patient monitoring purposes Use the Maximum sensitivity setting for improved poor perfusion performance and for faster tracking of rapid SpO2 saturation changes Stopping the SpO2 measurement 1 Remove the SpO2 sensor from the patient 2 Disconnect the sensor cable from the monitor 3 Select Audio Pause key to close the SpO2 probe off alarm Setting SpO2 alarms 1 Press the SpO2 key 2 Select SpO2 Alarm ...

Page 92: ...0 g The skin tones included in the study were light to dark For neonatal study the Arms of the collected convenience samples are 2 7 Oxy AF sensor in the SaO2 range of 87 100 collected 52 data points Oxy SE sensor in the SaO2 range of 81 100 collected 53 data points Troubleshooting SpO2 signal is poor Check the sensor and sensor positioning If in GE SpO2 configuration change the SpO2 Response aver...

Page 93: ...ate an oscillometric signal that may not be interpreted causing NIBP to time out The patient blood pressure can be monitored from the balloon pump device GE Healthcare monitors are designed for use with dual hose cuffs and tubing The use of single hose cuffs with dual hose tubing can result in unreliable and inaccurate NIBP data If a patient s beat to beat pulse amplitude varies significantly e g ...

Page 94: ...or in monitor 2 Cuff hose 3 Cuff of correct size 4 Brachial artery arrow printed on cuff 5 Cuff index line printed on cuff NOTE For a comprehensive list of accessories see the Supplies and Accessories catalog delivered with the monitor 2 1 4 5 3 ...

Page 95: ...ure is according to the cuff size you use When the neonatal cuff size is in use only NEO option is available NOTE If the cuff hoses can t be detected automatically the monitor will go to this selection automatically when you try to start the NIBP measurement You must set the inflation limits manually With these hoses AUTO option is not available 7 Verify or select the suitable measurement unit The...

Page 96: ...e steps for auto NIBP determinations by setting the time interval and how many times this interval is repeated 1 Press the NIBP key 2 Select Custom Setup 3 Set up time interval and repeat times for every series The cycle time can be set to 1 to 120 min or OFF The repeat option can be set to 1 to 25 times or OFF or cont Starting and stopping NIBP Auto From the keyboard Press the NIBP Auto On Off bu...

Page 97: ...ed by a change in the patient s position The NIBP feature is not validated for pregnant including pre eclamptic patients use When 1 hour has passed from the latest NIBP measurement the numeric value digits turn gray When 4 hours has passed from the latest NIBP measurement the gray numeric value digits are replaced by a dashed line NOTE For the NIBP trends the displayed and printed value is an aver...

Page 98: ...o determine the mean pressure and calculate the systolic and diastolic pressures During an NIBP determination the parameter deflates the cuff one step each time it detects two pulsations of relatively equal amplitude The time between deflation steps depends on the frequency of these matched pulses pulse rate of the patient However if the monitor is unable to find any pulse within several seconds i...

Page 99: ...Mechanical shock to the invasive blood pressure transducer may cause severe shifts in zero balance and calibration and cause erroneous readings When initializing the IBP parameter Invasive blood pressure alarm activation criteria may result in inactive limit alarms When using the electrosurgery unit ensure proper contact of the ESU return electrode to the patient to avoid possible burns at monitor...

Page 100: ... infusor 3 Flushing set 4 Disposable catheter 5 Transducer 6 Adapter cable for the IBP transducer 7 Adapter cable for dual IBP measurement You can monitor up to two pressure channels by using a dual cable NOTE For a comprehensive list of sensors and accessories see the Supplies and Accessories catalog 3 5 4 7 2 6 1 ...

Page 101: ...nel has not been zeroed the message InvBP s not zeroed appears The invasive pressure alarms advance to medium and high priority levels regardless of the zeroing NOTE IBP transducers must comply with the requirements of IEC 60601 2 34 must be provided with defibrillator protection have a frequency response exceeding 15Hz and contribute not more than 2mmHg to the overall measurement error Set up ven...

Page 102: ...ern is irregular The cursor is not available for pressures shown with a combined scale 1 Press the IBP key 2 Select IBP1 Setup IBP1 Cursor and IBP2 Setup IBP2 Cursor 3 Move the cursor up or down by turning the Trim Knob Every time the cursor is moved the time hours and minutes and pressure values appear on the screen In this way you can keep track of the changes made 4 You can remove the cursor by...

Page 103: ...elect Alarms Setup to adjust IBP or related alarms Troubleshooting Readings seem unstable Make sure that there are no air bubbles in the transducer system Flush and zero Place the transducer on the patient s mid heart level and zero Invasive blood pressure waveform is displayed but no numeric values are displayed Zero the channel Invasive blood pressure numerical values are displayed only for succ...

Page 104: ...100 ...

Page 105: ...ible burns at monitor measurement sites Also ensure that the ESU return electrode is near the operating area NOTE Temperature measurement response time is affected by use of esophogeal stethoscope with certain temperature sensors Temperature equipment to patient connection 1 Compatible temperature measurement capability 2 Adapter cable for temperature probes 3 Reusable temperature probe 4 Adapter ...

Page 106: ...or can display the delta value between different temperatures if they are displayed in the same digit field For example to display T2 T1 1 Press the Monitor Setup key 2 Select Screen Setup 3 Select Digit Fields 4 Select T1 T2 to one of the lower fields Setting temperature alarms 1 Press the Others key 2 Select Temp Setup choose Temp Alarms 3 Select Adjust Limits to set up the limits 4 Select T1 Al...

Page 107: ...the room Connect the exhaust to a scavenging system to prevent exposure to anesthetic agents Always ensure the correct size and fit of accessories according to patient type and application especially when monitoring pediatric and neonatal patients The size and fit of accessories may impact the measured gas concentration values at low tidal volumes It is recommended to have the gas sampling port cl...

Page 108: ... If a bacterial breathing system filter is not used a failure in the D Fend Pro water trap may cause a risk of patient crossinfection PATIENT CROSS INFECTION If the sampled gas is returned to the patient circuit ensure the protective function of the D Fend Pro water trap by replacing it at least once a week or immediately in case of a defective or missing bacterial breathing system filter Otherwis...

Page 109: ...e for N2O in realtime The E miniC requires manual selection from the monitor menu to compensate for N2O NOTE When monitoring neonatal or other patients that have high respiration rate or low tidal volume The CARESCAPE Respiratory Module and Airway Gas Option shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy NOTE The monitor also is comp...

Page 110: ...ent connection 1 E miniC module 2 Gas sampling line 3 Airway adapter with sampling line connector 4 Sampling line connector on the water trap NOTE For a comprehensive list of accessories see the Supplies and Accessories catalog ...

Page 111: ...E sCAiO or N CAiO module 2 Gas sample gas sampling line connector on the water trap 3 Gas sampling line 4 Gas sampling line connector on the airway adapter place the connector upwards 5 Airway adapter with sampling line connector 6 Heat and moisture exchanger with filter HMEF optional ...

Page 112: ...re set NOTE Check that the sample line is connected to the water trap before connecting the module to the monitor or turning on the monitor NOTE To minimize the amount of dust drawn into the gas sampling system always keep the water trap connected to the module When gas measurement is not in use you can disconnect the module from the monitor to eliminate the operating sound of the gas pump CO2 mea...

Page 113: ... measured CO2 OFF ON the CO2 measurement 1 Press the Airway Gas key 2 Select CO2 Setup Measurement 3 Choose OFF or ON Setting alarms Setting CO2 alarms 1 Press the Airway Gas key 2 Select CO2 Setup CO2 Alarm 3 Select Adjust Limits to set up the limits 4 Select EtCO2 Alarm FiCO2 Alarm to OFF ON the limits 5 You can also select Alarms Setup to adjust CO2 or related alarms Setting respiration rate al...

Page 114: ...FF ON the limits 5 You can also select Alarms Setup to adjust O2 or related alarms Anesthetic agent and N2O measurement NOTE B40 only NOTE The E sCAiO and N CAiO modules automatically identify the agent being used If the agent value is out of measurment range will be displayed on screen which means the value is invalid Selecting the agent scale 1 Press the Airway Gas key 2 Select Agent N2O Setup A...

Page 115: ...rature into account End tidal balance gas EtBal is the percentage of gas concentration not measured by the gas sensors An increased balance gas value may indicate the amount of nitrogen flushed out from the patient into the circuit The increase may be due to an accumulation of nitrogen during low flow anesthesia The MAC MACage and balance gas can be selected during digit fields set up and are disp...

Page 116: ...OTE B40 only The modules with agent identification option will automatically identify and select Isoflurane Desflurane Sevoflurane Enflurane and Halothane The E sCAiO module is able to identify two agents simultaneously and displaying them as primary and secondary agents The N CAiO module is able to identify and display one agent The inspiratory and expiratory concentrations of the agent are displ...

Page 117: ... sample gas flow is within 120 20 ml min for E sCO E sCAiO and N CAiO 150 25 ml min for E miniC Place the airway adapter between the HME and Y piece Place the airway adapter with all sampling ports upwards Always check the tightness of all connections Make sure that the gas sampling line is properly connected to the water trap and the water trap is properly connected to the airway gas module Gas l...

Page 118: ...thesia machine s user documentation to find out where and how the sample gas can be connected Connecting directly to the scavenging system 1 Connect the exhaust line to the monitor s sample gas outlet 2 Connect the exhaust line only to an open scavenging system where gas is removed at room pressure NOTE Do not connect the monitor directly to a strong vacuum scavenging system NOTE If the E miniC is...

Page 119: ...nical judgements Entropy values are not to be used as sole indicators of the patient status Check the sensor expiration date on the sensor package Do not use expired sensors Do not use a sensor for more than 24 hours Note Automatic sensor check may need to be disabled if the 70 Hz impedance check signal interferes with other equipment such as EEG module with evoked potentials measurement The devic...

Page 120: ...is derived from the RSA Data Security Inc MD5 Message Digest Algorithm NOTE Entropy sensors are latex and PVC free disposable and for single patient use only NOTE For a comprehensive list of accessories see the Supplies and Accessories catalog Entropy module keys There are two keys on the module Entropy Opens or closes the Entropy menu on the screen Check Sensor Starts the manual sensor check ...

Page 121: ...the entropy function will be disabled and the related menu is gray Entropy measurement checks Check that the sensor electrode passes the sensor electrode check when you are starting to monitor a new patient Selecting the EEG scale This selection affects the Entropy waveform and snapshots 1 Press the Entropy module key or press the Others key select Entropy 2 Select Entr EEG Scale 3 Select a value ...

Page 122: ...sensor does not pass the impedance check this option becomes selectable It allows you to start the measurement without completing the sensor check NOTE In this case the measurement may be unreliable 1 Press the Entropy module key or press the Others key select Entropy 2 Select Bypass Check Using the automatic Entropy sensor check To take the automatic sensor check into use the monitor will check t...

Page 123: ...ues seem unstable Check that the sensor is not dried out Check the sensor attachment and placement Check the patient status Entropy EEG signal is noisy Remove disturbing equipment from the proximity of the Entropy module or sensor Check the sensor s contact with skin Check electrodes Entropy EEG signal is poor Check the sensor s contact with skin Check electrodes Entropy waveform and numbers do no...

Page 124: ...120 For your notes ...

Page 125: ...ling line is connected to the water trap Arrhythmia Extra arrhythmias are detected Start relearning manually through ECG Relearn Extra Ventricular Fibrillations are detected Check the patient Check that the amplitude signals are sufficient Leads I and II Select the one with the largest amplitude to ECG 1 After selecting the leads start relearning manually Batteries Battery operation time is marked...

Page 126: ...ation calculation may count only ventilator produced inspirations and expirations Other electrical devices may interfere with the measurement Invasive pressures Readings seem unstable Make sure that there are no air bubbles in the transducer system Flush and zero Place the transducer on the patient s mid heart level and zero Invasive blood pressure waveform is displayed but no numeric values are d...

Page 127: ...lected the inflation limits in the NIBP Setup menu see Non invasive blood pressure NIBP Prevent motion artifacts Use cuffs of correct size Pulse oximetry SpO2 signal is poor Check the sensor and sensor positioning If in GE SpO2 configuration change the SpO2 Response averaging time to Normal Note that skin pigment causes differences Make sure that the patient is not moving Temperature Measurement f...

Page 128: ... patient status Check the ventilator and breathing circuit Arrhythmia Paused ECG Check the patient status Check the electrodes Art disconnect ABP disconnect UAC disconnect IBP Check the patient status Check the Art ABP UAC line Asystole Check the patient status Check the electrodes Battery A temperature high Battery B temperature high Replace the battery If the problem persists contact authorized ...

Page 129: ...hat the sensor is properly attached to the patient Entropy sensor check failed Check sensor placement and attachment Press each electrode in the sensor Replace the sensor Frame temperature high Make sure there is sufficient ventilation If the problem persists contact authorized service personnel Turn off the monitor wait for it cool down Freq PVCs Check the patient status Incompatible SpO2 Probe R...

Page 130: ... Try to re establish the connection Contact authorized service personnel Network recording Network recorder has been started Please wait until the recording is finished NIBP call service error NIBP Contact authorized service personnel NIBP manual Check the cuff and cuff hose NIBP cuff overpressure Check NIBP cuff hose and tubes Restart measurement NIBP cuff loose Check the cuff and cuff hose NIBP ...

Page 131: ...nished Recorder out of paper Add paper Recorder cover open Close the recorder cover Recorder input voltage high Recorder input voltage low Contact authorized service personnel Recorder thermal array overheat Contact authorized service personnel Recorder module removed Reconnect the recorder module if you need a recorder Recorder system error 29 The message rarely appear when the record information...

Page 132: ...Temp sensor error Contact authorized service personnel T1 temperature error T2 temperature error Check the probe whether is set to 400 Contact authorized service personnel V Fib Check the patient status V Tach Check the patient status Weak pulsation Check the patient status Check the NIBP cuff position and attachment Check that the cuff is not damaged Repeat the measurement and check the patient s...

Page 133: ...ed lead aVR right arm augmented lead Axil axillatory temperature BAEP brainstem auditory evoked potential Bal balance gas bar 1 atmosphere Beta BE beta frequency band Bigem bigeminy BIS bispectral index Blad bladder temperature Blood blood temperature C O measurement Body body temperature BP blood pressure Brady bradycardia BSA body surface area BSR burst suppression ratio B TO B beat to beat BTPS...

Page 134: ...volume index EE energy expenditure kcal 24h EEG electroencephalogram EEG1 first EEG waveform EEG2 second EEG waveform EEG3 third EEG waveform EEG4 fourth EEG waveform EEMG evoked electromyogram EEtot total energy expenditure elect electrode elev elevation EMC electromagnetic compatibility EMG electromyogram Enf enflurane Entr entropy EP evoked potential ESD electrostatic discharge Eso esophageal t...

Page 135: ...IEC International Electrotechnical Comission Imped impedance impedance respiration in inch Inf inferior Infl inflation limit insp inspiratory Inv invasive InvBP invasive blood pressure Irreg irregular ISM Industrial Scientific and Medical ISO International Standards Organisation Iso isoflurane ITBV intrathoracic blood volume IVR idioventricular rhythm J joule K kelvin kcal kilocalorie kJ kilojoule...

Page 136: ... BTPS pressure in BTPS conditions P g a CO2 difference between gastrointestinal carbon dioxide and arterial blood carbon dioxide concentration P g ET CO2 difference between gastrointestinal carbon dioxide and end tidal carbon dioxide concentration P STPD pressure in STPD conditions IBP1 IBP2 invasive pressure channel identification on module PA pulmonary arterial pressure PA pulmonary artery Pa Pa...

Page 137: ...t RF radio frequency RMS average root mean square power Room room temperature RQ respiratory quotient RR respiration rate total measured rtm rhythm RV residual volume RVEDV right ventricular end diastolic volume RVESV right ventricular end systolic volume RVP right ventricular pressure RVSW right ventricular stroke work RVSWI right ventricular stroke work index s second SA sinoatrial SaO2 arterial...

Page 138: ...volume TVexp expired tidal volume ml TVinsp inspired tidal volume ml Tx temperature label x being 1 2Tymptympanic temperature V Fib ventricular fibrillation V Run ventricular run V Tachy ventricular tachycardia v venous V ventricular V volume V Q ventilation perfusion ratio V0 5 volume expired during the first 0 5 seconds V1 0 volume expired during the first second VA alveolar ventilation VC vital...

Page 139: ...e and transport temperature 20 to 60 C 4 to 140 F Operating humidity 20 to 90 noncondensing Storage and transport humidity 10 to 90 noncondensing Operating atmospheric pressure 700 to 1060 hPa 525 to 795 mmHg Storage and transport atmospheric pressure 700 to 1060 hPa 525 to 795 mmHg E miniC module Environment Operating temperature 10 to 40 C 50 to 104 F Non operating temperature 25 to 70 C 13 to 1...

Page 140: ... to the alternate voltage 13 A 125 V or 6 A 250 V Fuse 250 V 2 5 Ah Battery Exchangeable lithium ion 2 pcs max Battery life 300 cycles minimum to 50 capacity Battery information model SM 201 6 11 1 V 3 52 Ah Charging time 2 hours to 90 per battery pack Operation time Up to 4 5 hours Recorder Power comsumption Standby 1 2 W Printing 10 W Recorder type Thermal array Resolution Vertical 8 dots mm 200...

Page 141: ...urement accuracy 5 or 5 bpm whichever is greater resolution 1 bpm Heart rate response time IEC 60601 2 27 201 7 9 2 9 101 b 5 Step increase from 80 to 120 bpm average 6 9 s 6 5 to 7 5 s Step decrease from 80 to 40 bpm average 8 2 s 7 6 to 10 0 s The heart rate calculation operates with irregular rhythms of IEC 60601 2 27 201 7 9 2 9 101 b 4 the heart rate after a 20 second stabilization period is ...

Page 142: ...ns Figure 4b halved amplitude 7 0 s 6 1 to 7 5 s Figure 4b normal amplitude 5 8 s 4 5 to 7 4 s Figure 4b doubled amplitude 6 1 s 5 1 to 7 0 s ST ST numeric range 9 to 9 mm 0 9 to 0 9 mV ST numeric accuracy 0 2 mm or 10 whichever is greater within the range of 8 to 8 mm ST numeric resolution 0 1 mm Pacemaker detection Input voltage range 2 to 700 mV Input pulse width 0 5 to 2 ms Input overshoot Spe...

Page 143: ...0 to 70 without motion 3 digits with motion 3 digits Adult Pediatric Neonatal 69 to 1 unspecified Wavelength of SpO2 probe LEDs Infrared LED 940 nm RedLED 660 nm Maximum energy of SpO2 probe LEDs Infrared LED 42 µJ pulse Red LED 62 µJ pulse NOTE This information may be useful to clinicians such as those performing photodynamic therapy Pulse rate Measurement range 30 to 250 bpm Display resolution 1...

Page 144: ...ubjects comprised both adult men and women and spanned a range of skin pigmentation GE TruSignal technology have been validated for low perfusion SpO2 accuracy over the specified range in a bench top testing against BioTek Index 2 patient simulator with 0 3 signal amplitude GE SpO2 Sensor Non motion 70 100 Motion 70 100 Low perfusion 70 100 Neonatal 70 100 TS E D TS E2 GE TS E4 GE 3 digits unspeci...

Page 145: ... equivalent to TS AF 10 TS AF 25 The sensors were clinically tested for neonatal accuracy with the following sensors OXY SE equivalent to TS SE 3 OXY AF equivalent to TS AF 10 TS AF 25 For supplemental data analysis presented in a format of Bland Altman in User s Reference Manual 2081504 001 please check the accompanying document or CD GE SpO2 Sensor 70 80 80 90 90 100 OXY E 2 3 digits 1 4 digits ...

Page 146: ...EDs less than 15 mW This information may be useful to clinicians such as those performing photodynamic therapy Measurement range 1 to 100 Display range 0 to 100 Calibrated against functional oxygen saturation Measurement accuracy Without motion Adult Pediatric 100 to 70 2 digits Neonate 100 to 70 3 digits With motion Adult Ped Neo 100 to 70 3 digits Low perfusion 100 to 70 2 digits 0 69 unspecifie...

Page 147: ... time less than 85 s Measurement ranges Systolic Adult Pediatric 30 to 290 mmHg Neonate 30 to 140 mmHg MAP Adult Pediatric 20 to 260 mmHg Neonate 20 to 125 mmHg Diastolic Adult Pediatric 10 to 220 mmHg Neonate 10 to 110 mmHg Accuracy According to AAMI SP10 2002 4 4 5 2 B accuracy of NIBP parameter was validated against the intra arterial method 1 Default initial inflation pressure Adult Pediatric ...

Page 148: ...probe 12F 5 to 8 s Disposable central temperature probe 9F 5 to 8 s Accuracy specifications apply in normal conditions after a 30 min warm up period Ambient temperature 18 to 28 C within 5 C of calibration Ambient pressure 660 to 1060 hPa 67 hPa of calibration Ambient humidity 20 to 80 within 20 RH of calibration Sampling rate E miniC module E sCO E sCAiO N CAiO module 150 25 ml min sampling line ...

Page 149: ...racy is specified in simulated ventilation With higher respiration rates and with varying ventilation methods the specifications may not be met 0 2 vol 2 of reading CO2 display resolution 0 1 0 1kpa or 1 mmHg CO2 total system response time E miniC module E sCO E sCAiO N CAiO module 2 4 seconds with a 3m sampling line 3 3 seconds with a 2 or 3m sampling line CO2 rise time E miniC module E sCO E sCA...

Page 150: ... sampling line 3 8 for Hal Anestheticagentsrisetime Hal Enf Iso Des 420 ms with a 3 m sampling line Hal 800 ms with a 3 m sampling line Hal Enf Iso Des 700 ms with a 6 m sampling line Hal 1800 ms with a 6 m sampling line Hal drift 0 1 vol Enf drift 0 1 vol Iso drift 0 1 vol Sev drift 0 1 vol Des drift 0 3 vol The E sCAiO N CAiO modules automatically identify the anesthetic agent present in the sam...

Page 151: ...soflurane 5 increases CO2 5 vol 0 4 vol Enflurane 5 increases CO2 5 vol 0 4 vol Desflurane 24 increases CO2 5 vol 1 2 vol Sevoflurane 6 increases CO2 5 vol 0 4 vol N2O 40 increases CO2 5 vol 0 4 vol Helium 50 decreases CO2 5 vol 0 3 vol If O2 compensation is not activated O2 40 95 decreases 0 3 vol If O2 compensation is activated O2 40 95 error 0 15 vol If N2O compensation is not activated N2O 40 ...

Page 152: ...e measured gas concentrations CO2 0 2 vol N2O 2 vol O2 2 vol Anesthetic agents 0 15 vol Gas cross effects Helium 50 vol Decreases CO2 5 vol readings 0 5 vol Decreases O2 50 vol readings 2 vol Xenon 80 vol Decreases CO2 5 vol readings 0 5 vol Decreases O2 14 vol readings 1 5 vol Display range Response Entropy RE State Entropy SE Burst Supression Ratio BSR 0 to 100 0 to 91 0 to 100 Display accuracy ...

Page 153: ...onment specified below The customer or the user of the monitor should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The monitor 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 CISP...

Page 154: ...nce Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transients bursts IEC 61000 4 4 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospita...

Page 155: ...sec Mains power quality should be that of a typical commercial or hospital environment If user of the equipment requires continued operation during power mains interruptions it is recommended that the equipment be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic field should be at levels characteris...

Page 156: ...IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrm...

Page 157: ...d reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be consider...

Page 158: ...ower of transmitter W Separation distance according to frequency of transmitter m 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 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 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 t...

Page 159: ......

Page 160: ...Milwaukee WI 53223 USA Tel 1 414 355 5000 1 800 558 5120 US only Fax 1 414 355 3790 GE Medical Systems Information Technologies GmbH Munzingerstrasse 5 79111 Freiburg Germany Tel 49 761 45 43 0 Fax 49 761 45 43 233 Asian Headquarters GE Medical Systems Information Technologies Asia 1 Huatuo Road Zhangjiang Hi tech Park Pudong Shanghai P R China 201203 Tel 86 21 3877 7888 Fax 86 21 3877 7451 0459 ...

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