Infinium OMEGA12 User Manual Download

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User’s Manual for Omega 12Patient Monitor

OMEGA12 Patient Monitor

User’s Manual

Infinium Medical Inc.

Summary of Contents for OMEGA12

Page 1: ...User s Manual for Omega 12Patient Monitor OMEGA12 Patient Monitor User s Manual Infinium Medical Inc...

Page 2: ...e PR Non invasive Blood Pressure NIBP Respiration Rate RR Temperature Temp Invasive Blood Pressure IBP Cardiac Output C O Additionally End tidal carbon dioxide EtCO2 and Bispectral Index BIS can be mo...

Page 3: ...er without the written permission of Infinium is strictly forbidden Contents of this manual are subject to changes without prior NOTE Manufacturer Responsibility Infinium is responsible for the effect...

Page 4: ...p this manual in the vicinity of the equipment so that it can be obtained conveniently when needed Intended Audience of this Manual This manual is intended for clinical professionals Clinical professi...

Page 5: ...p 70 11 NIBP 73 12 IBP 82 13 EtCO2 88 14 BIS 95 15 C O 106 16 Managing Patients 110 17 Trends 113 18 Patient History Data 118 19 Freezing Waveforms 120 20 Pharmacy Calculations 122 21 Printing 126 22...

Page 6: ...hazard do not use the equipment in the presence of flammable anesthetics vapors or liquids Do not use monitoring sensors during magnetic resonance imaging MRI Induced current could potentially cause b...

Page 7: ...sion 1 1 2 Caution CAUTION To ensure patient safety use only parts and accessories specified in this manual Magnetic and electrical fields are capable of interfering with the proper performance of thi...

Page 8: ...be considered to ensure the precision of measurement For special safety instructions on these conditions see chapters of this manual for reference accordingly Chemical leakage from broken LCD is pois...

Page 9: ...tional errors If this occurs the working environment should be investigated to identify the source of the interference and eliminate it Turn on and off the appliances in the vicinity to find out the i...

Page 10: ...etwork Alternating current AC Battery indicator AC DC dual use Serial number Date of manufacture Manufacturer Fragile handle with care This way up Keep dry Protect from rain Stacking limit by number M...

Page 11: ...ients regularly constantly in a prolonged period This device features audio and visual alarms Trend recording and printing NIBP recording and review alarm event system pharmacy calculations and C O ca...

Page 12: ...1 HDMI connector HDMI 2 3 USB connectors upgrade firmware or importing exporting configuration USB 4 Thermal printing Infinium STR 80 thermal printing is recommended 5 Non Invasive Blood Pressure con...

Page 13: ...eaker 12 AC Power indicator ON when AC power is connected OFF when AC power is connected 13 Power ON OFF for turning ON OFF the monitor 14 Battery Indicator ON when the battery is being charged or alr...

Page 14: ...that connects the patient monitor to other devices or system to communicate between beds and upgrade system network 20 EtCO2 Sensor Connector connecting external EtCO2 sensor module EtCO2 21 BIS Sens...

Page 15: ...a This area shows physiological alarm messages When multiple alarms occur they will be displayed circularly Select this area and the physiological alarm list will be displayed 4 System Status Bar Indi...

Page 16: ...male Patient monitor has no network connection Patient monitor is connected to a wire network successfully Wireless connection is working the white bar indicates the network signal strength Alarms are...

Page 17: ...less connection and network signal strength 3 Battery status and battery level display not installed in charge failure work correctly and battery level 4 Speaker volume adjust the speaker volume in ge...

Page 18: ...Symbol Soft Keys Name Explanation Setting Enter setting menu View Layout Enter layout menu Alarm Paused Pausecurrent alarm Alarm Off Turn off the alarm Alarm Audio Paused Pause the alarm sound Alarm A...

Page 19: ...14 Trend Review Open trend review window for current patient Pharmacy Calculator Open drug concentration calculation window Alarm setting Open alarm setting menu Config Manager Open configuration mana...

Page 20: ...for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601 1 1 If you have any question please contact us If it is not evident from the equip...

Page 21: ...arrier or the manufacturer If the packing case is intact open the package and remove the equipment and accessories carefully Check all materials against the packing list and check for any mechanical d...

Page 22: ...evice or meet the requirement of this manual To avoid the risk of electrical shock Use the battery if the integrity of the protective earth ground conductor is in doubt 3 4 2 Turning Power On Before y...

Page 23: ...e power ON OFF button for above 3 seconds and confirm the operation in pop up shut down window You can unplug the monitor to cut off connection from AC power CAUTION Although not recommended you can p...

Page 24: ...4 1 Figure 4 1 General Menu You can set 1 Heartbeat Sound Select Heartbeat Sound drop down menu to set the source of the heartbeat sound choose QRS Pulse IBP1 IBP2 and OFF the default setting is QRS i...

Page 25: ...splayFormat Select TimeDisplayFormat drop down menu and toggle between 24h and 12h The default setting is 12h 10 AnimationSetup Select AnimationSetup drop down menu and toggle between ON and OFF the d...

Page 26: ...Monitor 21 Figure 4 2 About Window To upgrade the firmware Select Upgrade Enter password as required to choose upgrade mode Figure 4 3 Upgrade Window 16 Help Click Help Download the video online to U...

Page 27: ...ult type is Default 3 Data Interval Select Data Interval drop down menu to set the data interval of HL7 message uploading Selections are 1s 5s 10s 15s 20s 25s 30s 1min The default setting is 1s 4 Repo...

Page 28: ...nt is OFF 3 Auto Print Select Auto Print drop down menu to set the time interval of Auto Print Interval options are 5 minutes 10 minutes 20 minutes 30 minutes 60 minutes and OFF When auto print interv...

Page 29: ...nable turning ON OFF BIS module BIS password generated from KN number is required 3 HL7 Module To enable turning ON OFF HL7 module HL7 password generated from KN number is required 4 Maintain Each equ...

Page 30: ...gement window In the Figure data of each row are stored in corresponding configuration file Default configuration can only be loaded operations other than this are all disabled such as delete save as...

Page 31: ...l enter the Pause Display mode the Pause Display window will appear as illustrated in Figure 4 8 Figure 4 8 Pause Display In this page the following functions can be accessed 1 Resume Display Click Re...

Page 32: ...ew Layout configuration window as illustrated in Figure 5 1 Figure 5 1 View Layout Number Function Explanation 1 Normal Screen Layout Display current layout Normal View or Big Font View 2 View Layout...

Page 33: ...the current layout setting to the configuration file and automatically arrange the currently available waveforms and parameters to ensure the best display effect 5 2 Normal View When the monitor is t...

Page 34: ...ect parameter on the right column the corresponding waveform will appear in the left cell Vice versa select waveform on the left column the corresponding parameter will appear in the right cell If the...

Page 35: ...iew Figure 5 5 shows the layout setup of Big Font View you could select 4 parameters with waveforms and 2 parameters without waveforms in Big Font View mode This mode suits the critical monitoring sit...

Page 36: ...RR Respiratory Waveform RW Switch Select the drop down menu to switch between RR and RW display 2 Time Interval Setting Select the drop down menu to set the time interval for trend data display Time I...

Page 37: ...click to select or unselect the specified history record If selected the specified measurement record will be involved for average value calculation History measurement data is selected by default 3 F...

Page 38: ...parameter trend in line graph 2 Parameter Setting Select parameters for display from the drop down menu Options are BC EMG SQI SR 3 Time Interval Setting Select the drop down menu to set the time int...

Page 39: ...o audible alarm tones even if a new alarm occurs Therefore the user should be very careful about whether to switch off the alarm sound or not Alarms must be set according to the patient s condition fo...

Page 40: ...ators When an alarm occurs the patient monitor will indicate it to the user through visual or audible alarm indications Detailed indications are Alarm Indicator High Level Medium Level Low Level Remin...

Page 41: ...m indications circularly 6 3 4 Alarm Status Symbols Apart from the aforementioned alarm indicators the patient monitor still uses the following symbols telling the alarm status indicates alarm sound i...

Page 42: ...u You can set 1 Pause Select the drop down menu to specify the pause mode for the softkey You can toggle between Alarm Pause and Audio Pause the default setting is Alarm Pause 2 Pause Time Set the ala...

Page 43: ...e will sound And you can cancel the Alarm Pause manually by reselecting the Alarm Pause softkey The softkey s name and symbol vary with the pre defined pause function Alarm Pause or Audio Pause 6 6 2...

Page 44: ...Alarm Pause softkey 6 6 3 1 Set Alarm Sound Pause Time You can select 1min 2min 3min or Infinite The default alarm sound pause time is fixed to be 2 min To set the alarm sound pause time please refer...

Page 45: ...Alarms When the monitor starts up a self check is performed In the meantime alarm lamp is lit in red yellow and blue respectively This indicates that the alarm lamps indicators are working properly F...

Page 46: ...e patient or table or instruments during defibrillation To avoid burns to patients during high frequency surgery monitor cables sensors must avoid contact with high frequency electrosurgical equipment...

Page 47: ...Patient s Skin Skin condition of the patient directly impact the ECG signal strength and the accuracy of the collected data To properly prepare the skin avoid bleeding or broken skin and choose flat...

Page 48: ...diately once the conducting gel is unpacked Use electrodes of the same brand Using different brands with dissimilar composition can hinder an accurate ECG trace When placing electrodes choose a flat n...

Page 49: ...the clavicle and near the left shoulder Red Electrode left leg LL placement on the left lower abdomen Figure 7 3 ECG Lead Placements 2 5 Leadwire Electrode Placement Following is an electrode configur...

Page 50: ...es on a surgical patient e g for open chest surgery the chest electrodes can be placed on the lateral chest or back To reduce artifacts and interference from electrosurgical units you can place the li...

Page 51: ...atient s need WARNING For paced patients you must set Pace Detection to Yes Otherwise the patient monitor could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak For pac...

Page 52: ...t ECG waveform and parameter color 32 colors are available as shown in Figure 7 5 The default color is Green Figure 7 5 ECG Color Menu 2 Speed Select Speed drop down menu you can choose 12 5 mm s 25mm...

Page 53: ...igh frequency or low frequency interference High frequency interference usually results in large amplitude spikes making the ECG signal look irregular Low frequency interference usually leads to wande...

Page 54: ...he pace pulse markers are shown on the ECG wave when a paced signal has been detected As shown in Figure 7 6 for more details please refer to 7 4 6 Figure 7 6 Pace Detection 7 5 2 ECG Alarm Setup In E...

Page 55: ...is the vertical difference between two measurement points with the R wave peak as the baseline for the measurement Figure 7 8 ST Segment 7 6 1 ST Security Information WARNING Factors such as medicati...

Page 56: ...ing ST Analysis ON OFF Select ST Analysis drop down menu and toggle between OFF and ON by default ST Analysis is OFF When ST analysis is switched on the measured ST numerics will be displayed in ECG p...

Page 57: ...as atrial fib flutter cause irregular baseline The patient is continuously ventricularly paced The patient has left bundle branch block 7 6 5 Adjusting ST Measurement Points The ST measurement i e ST...

Page 58: ...u can select the following positions J 40 J 60 J 80 or J 60 80 If the heart rate is greater than or equal to 120 bpm it is recommended that the ST point is set to J 60 ms If the heart rate is less tha...

Page 59: ...presence or absence of an arrhythmia Therefore a physician must analyze the arrhythmia information with other clinical findings CAUTION The sensitivity and specificity of the arrhythmia algorithm cann...

Page 60: ...ts 9 BGM Bigeminy 10 TGM Trigeminy 11 TAC Tachycardia 12 BRD Bradycardia 13 MIS Missed Beats 7 7 3 Changing Arrhythmia Alarm Settings To change arrhythmia alarm settings click ECG Menu select ARRAlarm...

Page 61: ...SU proof ECG cables Muscle Noise Inadequate skin preparation tremors tense subject and or poor electrode placement 1 Perform skin preparation again and re place the electrodes For more information ref...

Page 62: ...ck that the ECG gain is not set too low Adjust the gain as required 2 Check that the leadwires and patient cables are properly connected Change cable and lead wires 3 Check that the patient cable or l...

Page 63: ...th Therefore it cannot be used for diagnostic purpose If operating under conditions according to the EMC Standard EN 60601 1 2 Radiated Immunity 3V m field strengths above 1V m may cause erroneous mea...

Page 64: ...eplace the ECG cables if necessary 8 4 Preparing to Monitor Resp 8 4 1 Skin Preparation Before monitoring Resp prepare skin by the following steps Shave hair from skin at chosen sites Gently rub skin...

Page 65: ...trodes This is particularly important for neonates Some patients with restricted movement breathe mainly abdominally In these cases you may need to place the left leg electrode on the left abdomen at...

Page 66: ...r Select Color Color setting window will pop up 32 colors are available to choose The default color is Cyan 2 Resp Waveform Speed Select Speed drop down menu You can set speed to 6 25 mm s 12 5 mm s 2...

Page 67: ...ega 12Patient Monitor 62 Figure 8 3 Resp Alarm Setup NOTE Apnea Alarm is set to ON by default Change to apnea alarm is disabled 8 6 Resp Troubleshooting Please refer to Appendix C alarm messages for d...

Page 68: ...ctional oxygen saturation SpO2 measurement is applicable to adults pediatrics and neonates This monitor supports Infinium SpO2 module Nellcor SpO2 module and Masimo SpO2 module Infinium SpO2 No logo o...

Page 69: ...ctive For example High oxygen levels may predispose a premature infant to retrolental fibroplasia If this is a consideration do NOT set the high alarm limit to 100 which is equivalent to switching the...

Page 70: ...t sensor motion Others Incorrect sensor placement or incorrect SpO2 sensor is used Blood pressure cuff or other measuring sensor on the same limb as the SpO2 sensor 9 4 SpO2 Display The SpO2 waveform...

Page 71: ...oose a sensor may cause light leakage too tight a sensor may cause pulsation of the vein and make the measurement value inaccurate In case of high ambient temperature special attention should be paid...

Page 72: ...FastSAT You can set FastSat only when Masimo SpO2 module is used Select FastSAT drop down menu and toggle between ON and OFF The default setting is OFF 5 Sensitivity Mode You can set Sensitivity Mode...

Page 73: ...ear in Pleth waveform area Problem Corrective Action No SpO2 parameter window and waveform area are displayed 1 Check if SpO2 module is plugged properly 2 Check if the SpO2 parameter and waveform disp...

Page 74: ...more information please refer to Masimo website http www masimo com patents html No Implied License Possession or purchase of this device does not convey any express or implied license to use the dev...

Page 75: ...ature of 2 channels T1 and T2 can be displayed at the same time and the temperature difference between two channels T can be calculated and displayed Temp measurement is intended to use for adults ped...

Page 76: ...1 Temp Normal Setup In Temp Menu Select Normal Setup tab 1 Color Select Color Color setting window will pop up 32 colors are available to choose The default color is White 2 Temp Unit Select Temp Unit...

Page 77: ...for troubleshooting If the problem persists contact your service personnel Problem Corrective Method No Temp parameter area is display Check if Temp parameter is set to ON in View Layout Measurement...

Page 78: ...those obtained by a trained observer using the cuff stethoscope auscultatory method or an intra arterial blood pressure measurement device within the deviations specified by IEC 60601 2 30 NIBP measu...

Page 79: ...ic or continuous measurements If any abnormity occurs move the cuff to another site or stop the blood pressure measurements immediately The 1 and 2 minute intervals are not recommended for extended pe...

Page 80: ...en return to the previous mode 11 5 Understanding the NIBP Numerics The NIBP display shows numeric only as below Your display may be configured to look slightly different We ll explain NIBP numerics o...

Page 81: ...ure to select the correct patient category setting for your patient before measurement Verify the patient category and replace the cuff 2 Connect the NIBP cuff hose to the module s NIBP connector 3 Ch...

Page 82: ...asurement method to Manual 2 Start the measurement by selecting NIBP Start 3 Stop the measurement by selecting NIBP Stop 4 Measurement ends When the procedure is completed or measurement anomalies occ...

Page 83: ...up 32 colors are available to choose The default color is Yellow 2 Pressure Unit Select PressureUnit drop down menu and toggle between mmHg and kPa The default unit is mmHg 3 Inflation Mode Select Inf...

Page 84: ...tion which is no more than 147mmHg will start 6 Inflation Memory Select Inflation Memory drop down menu Turn ON OFF Inflation Memory When Inflation Memory is turned ON the monitor will save the inflat...

Page 85: ...splay area Enter the NIBP Tabular Trends Tab as shown in Figure 11 4 Check the data by scrolling the data list and you can manually set the number of viewable items on the current page by clicking the...

Page 86: ...at least once every two years or when you doubt the measured NIBP Leakage Test must be performed by your service personnel 11 10 2 CalibratingNIBP NIBP is not user calibrated Cuff pressure transducers...

Page 87: ...me blood pressure can be displayed Through specific calculation methods the systolic pressure diastolic pressure and mean arterial pressure can be obtained You can measure and monitor two invasive blo...

Page 88: ...cks are free of air bubbles 4 Position the transducer so that it is level with the heart approximately at the level of the midaxillary line 5 Select the appropriate pressure label for measurement 6 Ze...

Page 89: ...ted close the stopcock to the air and open the stopcock to the patient Zeroing failure may occur when pressure fluctuates or exceeds the valid range of zeroing pressure If zeroing fails try the follow...

Page 90: ...drop down menu to set speed 12 5 mm s 25 0mm s The default speed is 25 0mm s The larger the speed value is The faster the wave sweeps 4 Label Select Label drop down menu and then select your desired l...

Page 91: ...alarm levels high alarm limit and low alarm limit and alarm event recording for each parameter according to your needs 12 6 IBPTroubleshooting This section lists the problems that might occur If you...

Page 92: ...ero 4 Replace the transducer Zeroing failure 1 Make sure that the transducer is vented to air not to the patient and try again 2 Rezero the transducer and don t move the transducer and tubing when zer...

Page 93: ...sensor built into the CO2 module CO2 measurement is suitable to use for adults pediatric and neonates 13 2 EtCO2 Safety Information WARNING EtCO2 monitoring is an external function of the patient moni...

Page 94: ...ea and parameter display area are shown in Figure 13 1 Figure 13 1 EtCO2 Waveform and Parameter Display 13 5 EtCO2 Sensor Preparation 13 5 1 Preparing to Measure Mainstream CO2 You must perform a zero...

Page 95: ...destream CO2 When ambient temperature change exceeds over 10 like equipment transferring Rezeroing must be performed with the instructions specified by this manual 1 Plug the sensor cable into the mon...

Page 96: ...or Select Color drop down menu to set ECG waveform and parameter color 32 colors are available as shown in Figure 13 2 The default color is Yellow 2 EtCO2 Unit Select EtCO2 Unit drop down menu to set...

Page 97: ...lt setting is 16 10 Balance Gas Select Balance Gas drop down menu to set Gas Type and toggle between Room Air Nitrogen and Helium The default balance gas is N2O 11 Anesthetic Select Anesthetic menu to...

Page 98: ...13 3 EtCO2 Alarm Setup Menu 13 7 Calibrating EtCO2 Sensor For sidestream CO2 modules a calibration should be performed once every year or when the readings go far beyond the range For mainstream CO2...

Page 99: ...values are too low 1 Check whether the CO2 concentration of the measurement site If the environmental concentration is a bit high measured value tends to be lower than expected In the worst scenario...

Page 100: ...s should not come into contact with other conductive parts including earth To reduce the hazard of burns in the high frequency surgical neutral electrode connection the BIS sensor should not be locate...

Page 101: ...use the sensor When Electroconvulsive EsCT is performed during BIS monitoring it should be NOTED that ECT electrodes should be placed as far away from the BIS sensors as possible to minimize interfer...

Page 102: ...lateral cerebral hemisphere BIS monitoring measures the following parameters Parameter Explanation BIS The BIS numeric reflects the patient s level of consciousness It ranges from 100 fully awake to 0...

Page 103: ...time over the past 63s that is the signal was inhibited for 6s When SR 100 the EEG signal is displayed as a flat line It is valuable in medical applications to brain injury coma hypoxia hypothermia p...

Page 104: ...2 Connect the patient interface cable to the BISx 3 Secure the BISx to a convenient location preferably close to the patient s head 4 Clean the application site with alcohol and let dry 5 Place the B...

Page 105: ...ad Connect the BISx adapter cable to the BIS module connector Attach the BIS sensor to the patient s head following the instructions supplied with the sensor Select BIS Menu Switch to Sensor Check tab...

Page 106: ...skin contact If necessary clean and dry skin HIGH The impedance is above the limit Check the ground electrode connection and check if the electrolyte solution expires LEAD OFF Electrode falls off and...

Page 107: ...ck in the setup menu The BISx will start monitoring only after the impedance check status of all electrodes are PASS If unsupported sensors are used Unsupport message will appear in Sensor State and w...

Page 108: ...splay in BIS parameter area You can choose SR TP SEF or BC BC is only visible when Extended sensor is used 7 EEG WaveformScale WaveformScale is shown in the form of gridlines corresponding to the magn...

Page 109: ...nt Monitor 104 11 Notch filtering Notch With BIS filters you can filter out disturbances from the EEG signal and improve the signal quality Select Notch drop down menu Select OFF 50Hz 60Hz 50 60Hz the...

Page 110: ...out Setup 2 Check the BIS module function is enabled Displayed in EEG parameter area The patient has high muscle activity in the head area or noise from some interfering equipment is coupling to elect...

Page 111: ...the measurement results as desired for therapy decisions 15 2 C O Safety Information WARNING C O monitoring is an external function of the patient monitor please read thoroughly the manual that comes...

Page 112: ...Display Please refer to Chapter 5 5 15 5 C O Measurement 15 5 1 C O Equipment to Patient Connection Figure 15 1 C O Equipment for Connection 15 5 2 Preparing the C O Measurement 1 Connect the C O cabl...

Page 113: ...ue valid range for input is 0 001 0 999 3 BT Alarm Switch Select the button to switch ON OFF BT alarm 4 BT Alarm High Select BT Alarm High menu Enter Alarm High value valid range for input is 37 0 43...

Page 114: ...f the Catheter is correct 2 Catheter constant Make sure that the catheter constant for the measurement is appropriate to the injectate volume injectate temperature and catheter type used 3 Inject solu...

Page 115: ...itored as the defaultpatient During the monitoring process touch the patient information area in the upper left corner of the main screen to view and modify the patient information as shown in Figure...

Page 116: ...t Select Pause Display in extended soft keys area In the pop up page select Create New Patient WARNING If you do not erase data from the previous patient the new patient s data will be saved into the...

Page 117: ...ormation message will appear Full Patients please go to the History Review to delete it from list then you can create new patient To delete Select the History Review in the extended softkeys area ente...

Page 118: ...rt The trend review page includes 4 tabs Graphic Trends Tabular Trends NIBP Tabular Trends and Waveform Review They demonstrate the patient trend figure in different forms 17 2 View Graphic Trends Sel...

Page 119: ...soft keys area to enter the Trend review page Select TabularTrends tab to switch to the Tabular Trends window as shown in Figure 17 3 Figure 17 2 Tabular Trends Tabular Trends supports thermal printin...

Page 120: ...saved periodically the NIBP trend curve is different from the other parameters trend curves Select a row of data in the NIBP tabular list the red time line will navigate to the corresponding time poi...

Page 121: ...Time Select the record in Time list to load the saved data into waveform area and parameter area for display 2 Waveform This page can display 3 waveforms simultaneously Toselect the parameters whose...

Page 122: ...ct the number value on the right of Number label Set the maximum number of Waveform records displayed on the current page 7 Print Record By selecting the Print button in the bottom you can print out t...

Page 123: ...and export the historical data for analysis 18 2 History Data Select History Review in the extended soft keys area to enter History Data page as shown in Figure 18 1 Figure 18 1 History Data You can...

Page 124: ...tor 119 drive 4 Open Select Open in the bottom of the page The selected data will be loaded into Trend Review display as shown in Figure 18 2 For the page operations please refer to Chapter 17 Trend R...

Page 125: ...l time alarm messages will continue updating in the alarm area Therefore no alarm will be missed and loss of monitoring data will not happen during the freezing operation 19 3 Viewing Frozen Waveforms...

Page 126: ...rint In the Freeze menu select Wave 1 Wave 2 and Wave 3 drop down menu respectively and then select your desired waveforms for each Wave Select the Print button The selected waveforms and all numerics...

Page 127: ...al intravenous drip method can hardly ensure the accuracy and constancy of the dose The monitor provides a Drug Calculator for concentration calculation to aid medical care Therefore reference drug do...

Page 128: ...ceive of a drug at different infusion rates To see the Titration Table 1 Select Pharmacy Calculator in the extended soft keys area Enter Pharmacy Calculator window Select Titration Table tab Titration...

Page 129: ...em Unit Formula Amount Amount g series mcg mg g unit series unit KU MU mEq series mEq Amount Dosage Infusion Time Amount Weight dependent Amount Weight dependent Dosage Infusion Time Weight Volume Vol...

Page 130: ...usion Rate Weight dependent ml h Infusion Rate Dosage Weight Concentration 20 2 5 Titration Table Calculation Formula Item Unit Formula Infusion Rate ml h Infusion Rate Dosage Concentration Infusion R...

Page 131: ...at preset intervals If the Alarm is set on an alarm recording will be triggered automatically as alarms occur 21 3 Stop Printing You can manually stop a recording or recording stop automatically 21 3...

Page 132: ...r the current page will be printed including Patient Name Patient ID Date Time NIBP SYS DIA SpO2 HR PR Resp Temp ST segment etc Parameter Printing example is shown in Figure 21 2 For illustration only...

Page 133: ...elect Printer Menu Set Alarm Print ON The automatic alarm printing is turned ON For automatic printing alarm setting please refer to 4 3 Printer Menu 21 7 NIBP List Printing 21 7 1 Printing Content NI...

Page 134: ...g Paper Jam If the recorder works incorrectly or produces unusual sounds check if there is a paper jam first If a paper jam is detected follow this procedure to remove it 1 Open the recorder door 2 Ta...

Page 135: ...ery out of children s reach Use only batteries specified in the chapter on Accessories Use of a different battery may present a risk of fire or explosion Keep batteries in their original package until...

Page 136: ...attery Status Battery Power Indicators On screen battery symbols and battery alarm message indicate the current status of the battery 22 4 1 Battery Power Indicators Solid Green Indicates that the bat...

Page 137: ...ery needs at least two conditioning cycles when it is put into use for the first time A battery conditioning cycle is one complete uninterrupted charge of the battery followed by an uninterrupted disc...

Page 138: ...onitor when it is not used for a longer period of time to avoid potential damage caused by battery leakage Storing batteries in high temperatures for long periods of time will significantly reduce the...

Page 139: ...infection For the method to control infection consult your hospital s Infection Control Officer or Epidemiologist The responsible hospital or institution shall carry out all cleaning and disinfection...

Page 140: ...and disconnect it from the power line 2 Clean the display screen using a soft clean cloth dampened with a glass cleaner 3 Clean the exterior surface of the equipment using a soft cloth dampened with t...

Page 141: ...are not allowed when the patient is monitored If you discover a problem with any of the equipment contact your service personnel or us Do not use or store equipment outside the specified temperature...

Page 142: ...e that the batteries meet the performance requirements Make sure that the patient monitor is in good working condition Make sure that the grounding resistance and leakage current meet the requirement...

Page 143: ...accessories or contact us to confirm the compatibility of the accessories with the device prior to use Failure to do so may cause injury to patient Single use accessories are not designed to be reuse...

Page 144: ...Wavelength emitted by pulse oximetry probe is 600 1000nm The maximum photic output consumption of the sensor is less than 18 mW The information about the wavelength range and maximum photic output co...

Page 145: ...ingress of water IPX2 A 1 2 Environmental Specifications Item Temperature Relative humidity Barometric kPa Operatingconditions 5 40 15 95 80kPa 105kPa Storageconditions 20 55 10 95 80kPa 105kPa WARNIN...

Page 146: ...charge battery with ambient temperature 25 Charge Time Monitor ON or OFF Charge 90 within 4 hours and full within 5 hours A 3 Hardware Specification A 3 1 Display Specification Screen Type TFT LCD Scr...

Page 147: ...o 12 physiological parameters supported 2 Waveform parameter customization 3 Waveform area dynamic setup 4 32 sets of colors 5 6 display modes Normal View Big Font View OxyCRG View BISTrend View C OMe...

Page 148: ...meter data saving Waveform recording ECG SpO2 IBP RESP etc 16s duration per waveform Patient Review Patient information display supported Sorting by time supported Data Export USB FlashDisk exportatio...

Page 149: ...hysiological Parameters HR PVCs ST ARR RR TP SpO2 PR PI Masimo NIBP SYS NIBP DIA IBP ART SYS IBP ART DIA IBP PA SYS IBP PA DIA IBP CVP MAP IBP RAP MAP IBP LAP MAP IBP ICP MAP B T C O EtCO2 AWRR BIS Ph...

Page 150: ...tory Patient Data Export Installation of our DataManager software on PC allows you to view historical patient data stored in different devices within the LAN When the DataManager Service is enabled on...

Page 151: ...very Time 5s Patient Leakage Current 10uA Calibration Signal 1mV peak to peak value 10 ESU Protection Cut mode 300W Coagulate mode 100W Recovery time 10s PACE Pulse Pace Pulse Markers Pace pulses meet...

Page 152: ...lar bigeminy 3c 120 1 bpm Bidirectional systoles 3d 90 2 bpm Response Time to Heart Rate Change From 80 to 120bpm less than 12 s From 80 to 40bpm less than 12s Response to Tachycardia 12s Tall T Wave...

Page 153: ...limit 2 bpm Default value 50bpm Adult 75bpm Pediatric 100 bpm Neonate ST Alarm High Low limit 0 20 2 00mV Default value 0 30mV ST Alarm Low 2 00 high limit 0 20 mV Default value 0 30mV A 5 2 Resp Resp...

Page 154: ...tance Measurement range 0 50 32 122 Resolution 0 1 Unit Error Temp range Error 0 34 9 0 2 35 0 39 9 0 1 40 0 44 9 0 2 45 0 50 0 0 3 Channel 2 channels Minimum time for accuratemeasurement Body surface...

Page 155: ...e 85 0 PR Alarm High High limit 2 300bpm PR Alarm Low 15 low limit 2 bpm PI Alarm High Masimo Low limit 0 2 20 0 Default value 20 0 PI Alarm Low Masimo 0 0 high limit 0 2 Default value 0 3 SpO2 Alarm...

Page 156: ...0 02 20 Pulse Rate Measurement Range 20bpm 250bpm Resolution 1bpm Accuracy 20bpm 250bpm 3bpm A 5 5 NIBP General Specification Standard ISO 80601 2 30 2019 Measurement Method Oscillometry Mode of Opera...

Page 157: ...t 120mmHg Pediatric 90mmHg Neonate Sys Low 40 high limit 5 mmHg Default value 90mmHg Adult 70mmHg Pediatric 40mmHg Neonate D a High Adult low limit 5 210mmHg Pediatric low limit 5 150mmHg Neonate low...

Page 158: ...mmHg Software Overpressure Protection Adult Pediatric 297mmHg 3mmHg Neonate 147mmHg 3mmHg PR Measurement Range 40 240bpm PR Accuracy 2 or 3bpm whichever is greater SunTechModule Human Standard ISO8060...

Page 159: ...er 10mmHg 3mmHg or 4 whichever is greater Number Of Channels 2Channels Zeroing Range 120mmHg Excitement Voltage 5VDC 2 Sensitivity 5uV V mmHg Impedance Range 300 3K Sweep Speed 12 5mm s 25 0mm s Wavef...

Page 160: ...whichever is greater BT IT 0 1 C O Graphical Trends Capacity 256 sets Alarm Limit Range BT Alarm High Low limit 1 43 0 Default value 39 0 BT Alarm Low 23 0 high limit 1 Default value 36 0 A 5 8 EtCO2...

Page 161: ...0 hours Noise At 5 CO2 concentration the Root Mean Square RMS of sensor noise is not greater than 0 25 mmHg Frequency 100Hz awRR Measurement Range 2 150 min rpm awRR Measurement Precision 1rpm Alarm L...

Page 162: ...ndwidth 0 25 100Hz 3dB High Filter Cut Off Frequencies 15 Hz 65 dB octave 30 Hz 75 dB octave 50 Hz 85 dB octave Low FilterCut Off Frequencies 0 5 1 0 2 0 and 5 0 Hz 12 dB octave Measurement Parameter...

Page 163: ...diatric 75bpm Neonate 100bpm Alarm Level Medium Alarm Record OFF Alarm Source HR Color Speed 25 0 mm s ECG Gain 1 0 Lead Set 5 lead ECG Filter Monitor ECG Notch 50Hz 60Hz ECG Cascade ON Paced OFF B 1...

Page 164: ...dium Alarm Record OFF ST Analysis ON ST Segment Auto ST Point J 40ms ST Point adjustment ON ISO Point 105ms J Point 180ms B 2 Resp Setup Item Factory Default Settings RR Alarm ON OFF ON Alarm High Adu...

Page 165: ...igh Adult 130bpm Pediatric 160bpm Neonate 200bpm Alarm Low Adult 50bpm Pediatric 75bpm Neonate 100bpm Alarm Level Medium Alarm Record OFF Color Speed 12 5mm s PR Source SpO2 B 4 Temp Setup Item Factor...

Page 166: ...BP DIA Alarm ON OFF ON Alarm High Adult 90mmHg Pediatric 70mmHg Neonate 60mmHg Alarm Low Adult 50mmHg Pediatric 40mmHg Neonate 20mmHg Alarm Level Medium Alarm Record OFF Color Pressure Unit mmHg Mode...

Page 167: ...Alarm ON OFF ON CVP RAP LAP ICP Alarm High 30 mmHg Alarm Low 10 mmHg Alarm Level Medium Alarm Record OFF Color Pressure Unit mmHg Speed 25 0mm s Parameter Label IBP1 ART IBP2 PA Parameter Ruler IBP1 1...

Page 168: ...um Alarm Record OFF awRR Alarm ON OFF ON Alarm High Adult 30 Pediatric 30 Neonate 100 Alarm Low Adult 8 Pediatric 8 Neonate 30 Alarm Level Medium Alarm Record OFF Color Unit mmHg Speed 12 5mm s Wavefo...

Page 169: ...S Setup Item Factory Default Settings BIS Alarm ON OFF ON Alarm High 70 Alarm Low 20 Alarm Level Medium Alarm Record OFF Color Speed 25mm s Display EEG1 Parameter1 SEF Parameter2 SR Scale 50 V Smoothi...

Page 170: ...the respiration signal was so weak that the monitor cannot perform respiration analysis Check the patient s Condition electrode placement and the Resp connections Note XXX represents Physiological par...

Page 171: ...e patient or the module check the connection If the alarm persists replace it with a new sensor SpO2 Sensor Fault Low Troubleshoot the problem with instructions specified by the manual that comes with...

Page 172: ...r Leak Low Check the NIBP cuff and pump for leakages NIBP System Error Low Re plug the module or restart the monitor NIBP Timeout Low An error occurred during NIBP measurement and therefore the monito...

Page 173: ...ow Check the sensor connection and reconnect the sensor If the alarm persists replace it with a new sensor BIS Error Low Check or replace the sensor BIS REF Node Off Low Check electrode placement repo...

Page 174: ...ation in which it will be used The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below Other devices may affec...

Page 175: ...ment Guidance Radio frequency RF emissions CISPR 11 1 Group The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interferenc...

Page 176: ...geIEC 61000 4 5 1 kV differentialMode 2 kV differentialMode 1 kV differentialMode 2 kV differentialMode Mains power quality should be that of a typical commercial or hospital environment Voltage dips...

Page 177: ...nce which can be calculated using the formula applicable to the frequency of the transmitter The formulas for calculating the recommended separation distance are as follows P d 2 1 P d 2 1 80 MHz to 8...

Page 178: ...n which radiated RF disturbance are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF com...

Page 179: ...4G Operating Frequency IEEE 802 11b g n HT20 2412MHz to 2462MHz IEEE 802 11n HT40 2422MHz to 2452MHz Modulation IEEE for 802 11b DSSS CCK DQPSK DBPSK IEEE for 802 11g OFDM 64QAM 16QAM QPSK BPSK IEEE...

Page 180: ...an radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interferen...

Page 181: ...Patient Monitor 176 Infinium Medical Inc Website www infiniummedical com Address 12151 62nd St North 5 Largo Fl 33773 USA Toll Free US call only 866 918 8434 International 1 727 531 8434 Fax 1 727 531...

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Infinium OMEGA12, User Manual

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