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Infinium OMEGA12 User Manual

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User's Manual for Omega 12Patient Monitor
OMEGA12 Patient Monitor
User's Manual
Infinium Medical Inc.

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  • Page 1 User’s Manual for Omega 12Patient Monitor OMEGA12 Patient Monitor User’s Manual Infinium Medical Inc.
  • Page 2 (EtCO2), and Bispectral Index (BIS) can be monitored through plug-in module, the measurement can be displayed, reviewed, stored, and printed. Product Components: Portable and all-in-one integrated, the Omega12 contains the main unit and accessories (temperature sensor, pulse oximetry sensor, disposable electrodes, ECG lead, blood pressure cuff and tubings).
  • Page 3 Infinium shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. This manual may refer to information protected by copyrights or patents.
  • Page 4 User’s Manual for Omega 12Patient Monitor Preface 【Manual Description】 This manual describes the uses, features, operations and safety messages of the patient monitor. Before using this equipment, observance of the manual is a prerequisite for proper performance and correct operation and ensures patient and user safety. Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.

  • Page 5: Table Of Contents

    User’s Manual for Omega 12Patient Monitor Content 1 Safety...........................1 2 Monitor Description....................6 3 Basic Operations......................15 4 Setup.......................... 19 5 Display Mode......................27 6 Alarm......................... 34 7 ECG........................... 41 8 Resp........................... 58 9 SpO2.......................... 63 10 Temp........................70 11 NIBP........................73 12 IBP...........................82 13 EtCO2........................

  • Page 6: Safety

    User’s Manual for Omega 12Patient Monitor 1 Safety 1.1 Safety Information WARNING  Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. CAUTION  Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.
  • Page 7 User’s Manual for Omega 12Patient Monitor electrical shock to the patient.  Do not come into contact with patients during defibrillation. Otherwise, serious injury or death could occur.  Do not use the equipment in the presence of flammable anesthetics, vapors or liquids. ...
  • Page 8 User’s Manual for Omega 12Patient Monitor  An indicated potential hazard or unsafe practice that, if not avoided, could result in minor personal injury, product malfunction, damage or property loss.  Both the monitor and the devices that connected to this equipment, must be grounded together.
  • Page 9 User’s Manual for Omega 12Patient Monitor electronic interference (such as electronic surgical equipment, cell phones, two-way radar for vehicles, electronic devices, etc.) in medical care settings. The high level of interference caused by the immediate vicinity, or strong transmitter power of the interfering sources may interrupt the normal function of this equipment.
  • Page 10 User’s Manual for Omega 12Patient Monitor Computer network 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: Maximum number is 8 for the symbol in the illustration.

  • Page 11: Monitor Description

    User’s Manual for Omega 12Patient Monitor 2 Monitor Description 2.1 Intended Use This device is intended to be used for monitoring, and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. Critical physiological parameters include ECG(Electrocardiogram), Heart Rate (HR), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Respiration Rate (RR), Temperature (Temp), Invasive Blood Pressure (IBP), Cardiac Output (C.O.).
  • Page 12 Symbol HDMI HDMI connector USB connectors: 2&3 upgrade firmware or importing/exporting configuration. Thermal printing: Infinium STR-80 thermal printing is recommended NIBP Non-Invasive Blood Pressure connector Connector for Temp probe 1 Connector for Temp probe 2 AAMI ECG cable connector SpO2 sensor connector （ sensor connector varies with SpO2 SpO2 modules）...
  • Page 13 User’s Manual for Omega 12Patient Monitor Alarm Status Symbols: LED indicators tell the priority of the technical and physiological alarm High: Red with quick flashes,2 flashes per second Medium: Yellow with slow flashes,1 flash per second Low: Solid blue without flashes Speaker AC Power indicator: ON: when AC power is connected.
  • Page 14 User’s Manual for Omega 12Patient Monitor EtCO2 Bracket: installing EtCO2 module Equipotential Grounding: connecting other instruments and equipment with equipotential grounding system to eliminate the ground potential difference between different equipment to ensure safety 100-240V AC Power Input: 50/60Hz 100~240VAC50/60Hz 1.3-0.5A 10/100M Self-Adaptive Network Interface: It is a standard RJ45 connector that connects the patient monitor to other devices or...
  • Page 15 User’s Manual for Omega 12Patient Monitor Figure 2-3 Normal Monitor View Number Explanation Patient Information Area This area shows the patient information such as patient category, name, gender, ID. Technical Alarm Area This area shows technical alarm messages and prompt messages. When multiple messages come, they will be displayed circularly.
  • Page 16 User’s Manual for Omega 12Patient Monitor Extended Soft Keys Area: Click this button, and extended soft keys area will pop up for quick function access. Parameter Area: Displaying the real-time measurement value corresponding to each parameter module. Its waveform is displayed in the same row in the waveform area.
  • Page 17 User’s Manual for Omega 12Patient Monitor Reset the alarm system Freeze: Freeze or unfreeze the waveform display Print: Start or stop the printing procedure. Start/Stop: Start/Stop measuring the non-invasive blood pressure View Layout: Set up the waveform in main display and parameter display layout. Main Menu: Configure the system parameter.
  • Page 18 User’s Manual for Omega 12Patient Monitor 10) Night Mode: Switching between "night mode" and "day mode". 11) UsageInfo: A new window will pop-up to show the current status of the monitor, including CPU usage, memory usage and runtime etc. NOTE ...
  • Page 19 User’s Manual for Omega 12Patient Monitor Open trend review Trend Pharmacy Open drug concentration window for current Review Calculator calculation window patient. Open configuration Alarm Open alarm setting Config setting menu Manager management menu Night Turn on night mode Mode...

  • Page 20: Basic Operations

    User’s Manual for Omega 12Patient Monitor 3 Basic Operations 3.1 Description The following section describes the basic operations of the monitor before it is used. 3.2 Safety Precautions WARNING  Please use the installation accessories authorized by us.  The software copyright of the equipment is solely owned by us. No organization or individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.
  • Page 21 User’s Manual for Omega 12Patient Monitor  Make sure that the operating environment of the equipment meets the specific requirements. Otherwise, unexpected consequences, e.g., damage to the equipment, could result.  Please read this manual thoroughly to ensure the proper use of the product and safety of both patient and operator.
  • Page 22 User’s Manual for Omega 12Patient Monitor 3.4 Getting Started 3.4.1 Connecting to AC Power Source The monitor is powered by AC. Before connecting the AC power source, please make sure that the voltage and frequency of the AC power source are the same as the voltage and frequency marked on the power plug.
  • Page 23 User’s Manual for Omega 12Patient Monitor Check that the patient settings such as [Alarm limit.], [Patient Cat.], [Paced], etc., are appropriate for your patient. Change setting according to your need for measurements. Start Monitoring. Refer to the appropriate measurement section for details of how to perform the measurements you require.

  • Page 24: Setup

    User’s Manual for Omega 12Patient Monitor 4 Setup To meet the patient needs in different clinical settings, you can set up the monitor accordingly in General Menu, Printer Menu, Module Menu, Config Manager. For specific parameter measurement, the related alarm setting is complex, thus we’ll introduce its setup in separate chapters.
  • Page 25 User’s Manual for Omega 12Patient Monitor Select “Temp Unit” and toggle between [ºC] and [ºF]. the default setting is ºC. Weight/HeightUnit Select “Weight/HeightUnit” to set Weight/Height Unit and toggle between kg/cm and lb/inch. The default setting is kg/cm. EtCO2 Unit Select “EtCO2 Unit”...
  • Page 26 User’s Manual for Omega 12Patient Monitor 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 USB drive  Click and play the video.
  • Page 27 User’s Manual for Omega 12Patient Monitor 4.2 HL7 Menu Select “Main Menu” → “HL7 Menu” to enter HL7 Menu, as illustrated in Figure 4-4. Figure 4-4: HL7 Menu For patient data transmission, HL7 needs to be configured: HL7 EnableService Click “HL7 Service”button to turn ON/OFF HL7 Service, the default setting is OFF. When HL7 service is OFF, you could change HL7 settings.
  • Page 28 User’s Manual for Omega 12Patient Monitor 4.3 Printer Menu Select “Main Menu” → “Printer Menu”, as shown in Figure 4-5. Figure 4-5: Printer Menu You can set: Status If the monitor is connected to the printer successfully, the status will be “Connected”;If connection fails, the status will be “Disconnected”.
  • Page 29 User’s Manual for Omega 12Patient Monitor display. 4.4 Module Menu Select “Main Menu” → “Module Menu” to enter ModuleMenu window, asillustrated in Figure 4-6. Figure 4-6: Module Menu To avoid the improper operation of the monitor due to accidentally changed configuration, some configurations require password from authorized personnel.
  • Page 30 User’s Manual for Omega 12Patient Monitor 4.5 Config Manager To meet the health care demand for different patient category, you can adjust the settings as required and then save it as a specific Config. Besides the default Config provided by default, you can create new local configurations or customize local configurations.
  • Page 31 User’s Manual for Omega 12Patient Monitor Export Select the row in configuration list (corresponding to the configuration file), click “Export” and the selected configuration will be exported to the specified USB drive. 4.6 Pause Display Select “Pause Display” in the softkeys area, the monitor will enter the Pause Display mode, the “Pause Display”...

  • Page 32: Display Mode

    User’s Manual for Omega 12Patient Monitor 5 Display Mode The Omega12 patient monitor has five display modes: Normal View, Big Font View, OxyCRG View, C.O. View,and BIS Real-time Trending View, the display format of waveforms and parameters are different from each other in different display modes. For more details, see the explanation of each display mode.
  • Page 33 User’s Manual for Omega 12Patient Monitor OK: Click the button, settings will be saved into configuration file and applied to monitor immediately, Normal Screen Layout will update. NOTE  If the measurement module is not in place, corresponding parameters and waveforms can’t be displayed.
  • Page 34 User’s Manual for Omega 12Patient Monitor Figure 5-3: Normal View Layout In this mode, the screen could display 8 waveforms at most on main page simultaneously. And you could select from 13 waveforms: ECG I, ECG II, ECG III, ECG AVR, ECG AVF, ECG AVL, ECG V, Pleth, Resp, IBP1, IBP2, EtCO2, BIS.
  • Page 35 User’s Manual for Omega 12Patient Monitor 5.3 Big Font View Swipe left and right on the touch screen using two or more fingers to switch between the Normal View and the Big Font View, as illustrated in Figure 5-4. Big Font View Layout window will In Big Font View mode, select “View/Layout”...
  • Page 36 User’s Manual for Omega 12Patient Monitor 5.4 OxyCRG View Select “OxyCRG” soft key , Enter real-time OxyCRG View display page, as shown in Figure 5-6. Figure 5-6: OxyCRG View Number Explanation Respiratory Rate (RR)/ Respiratory Waveform (RW) Switch: Select the drop-down menu to switch between RR and RW display.
  • Page 37 User’s Manual for Omega 12Patient Monitor 5.5 C.O. Measure View  Enter C.O. Measure View, as shown in Figure 5-7. Select “C.O. Measure” soft key Figure 5-7: C.O. Measure View Number Explanation Real-time Measurement Window: display the real-time measuring parameter and waveform. History Measurement Window: display history measurement data, click to select or unselect the specified history record.
  • Page 38 User’s Manual for Omega 12Patient Monitor 5.6 BIS Trend View  Enter BIS Trend View, as shown in Figure 5-8. Select “BIS Trend” Figure 5-8: BIS Trend View Number Explanation Real-time Trend Field: Display real-time specified parameter trend in line graph. Parameter Setting: Select parameters for display from the drop-down menu.

  • Page 39: Alarm

    User’s Manual for Omega 12Patient Monitor 6 Alarm 6.1 Description Alarms, triggered by a vital sign that appears abnormal or by technical problems of the patient monitor, are indicated to the user by visual and audible alarm indications. We’ll introduce alarm settings and functions in this chapter. 6.2 Safety Precautions WARNING ...
  • Page 40 Single Beep. distinct from heartbeat Alarm Double Beep. and pulse sound for easy Tones identification. Infinium Alarm message appears on the top of the screen. You can click the area to Black Text with Black Textwith Black Text with White...
  • Page 41 User’s Manual for Omega 12Patient Monitor NOTE  When multiple alarms of different levels occur simultaneously, the patient monitor will select the alarm of the highest level and give visual and audible alarm indications accordingly.  When multiple alarms of different levels occur simultaneously in the same area, only high-level alarm will be displayed.
  • Page 42 User’s Manual for Omega 12Patient Monitor 6.5 Alarm Setup Select “Alarm Setup” in the extended softkey area  Enter Alarm Setup Menu 6.5.1 Set Alarm Properties for All Parameters There are 3 ways to set alarm properties for the specified parameter: 1）Select “Alarm Setup”...
  • Page 43 User’s Manual for Omega 12Patient Monitor 6.6 PauseAlarm and Pause Audio Alarm 6.6.1 Set the Pause Function You can pause the alarm or pause the alarm sound according to your Pause setting. To set the pause function: 1）Select “Alarm Setup” in the extended softkey area  Click “General Alarm Menu” tab ...
  • Page 44 User’s Manual for Omega 12Patient Monitor 6.6.3 Silencing the Alarm Sound If the pause function is set to “Audio Pause”, selecting “Audio Pause” will silence the alarm sound. When the alarm sound is muted:  Both physiological alarms and technical alarms are off during the set alarm pause time. ...
  • Page 45 User’s Manual for Omega 12Patient Monitor 6.7 Alarm Reset Select “Alarm Reset” soft key  Reset the alarm system. When the alarm system is reset successfully, the Alarm Reset symbol will appear in the system status bar. NOTE  When monitor is in Alarm Reset state, if a new alarm occurs, the Alarm Reset symbol will disappear, alarm light and sound will be generated normally.

  • Page 46: Ecg

    User’s Manual for Omega 12Patient Monitor 7 ECG 7.1 ECG Description The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the patient monitor as a waveform and a numeric. The monitor provides 3-lead/5-lead monitoring, ST segment and arrhythmia analysis. Figure 7-1: ECG Display 7.2 ECG Safety WARNING...
  • Page 47 User’s Manual for Omega 12Patient Monitor Figure 7-2: ECG Display Number Explanation Number Explanation ECG Lead Label PVCs Label ECG Gain PVCs Value ECG Filter Label ECG 1mV Calibration Bar ECG Sweep Speed ECG Waveform ECG Name ECG Alarm Limit HR Unit ST Parameter Label Heart Beat Symbol...
  • Page 48 User’s Manual for Omega 12Patient Monitor Check whether the electrode package is intact within the expiration date.Tear off the protective paper on the back of the electrode sheet. Make sure the electrode gel is moist. Attach the clips or snaps to the electrodes before placing them. Place the electrodes on the prepared skin.
  • Page 49 User’s Manual for Omega 12Patient Monitor Chest 5 White/Black Brown/Orange Chest 6 White/Purple Brown /Purple 7.4.4 ECG Lead Placements The electrode placement illustrations in this chapter adopt the AHA standard: 3-Leadwire Electrode Placement Following is an electrode configuration when using 3 lead-wires: White Electrode （right arm）...
  • Page 50 User’s Manual for Omega 12Patient Monitor  V1 placement: on the fourth intercostal space at the right sternal border.  V2 placement: on the fourth intercostal space at the left sternal border.  V3 placement: midway between the V2 and V4 electrode positions. ...
  • Page 51 User’s Manual for Omega 12Patient Monitor symbol is displayed when the “Pace Detection” is set to ON. The pace pulse markers “|” are shown on the ECG wave when the patient has a paced signal. The paced symbol will not be displayed when the “Pace Detection” is set to OFF To change the paced status: Select ECG parameter area or waveform area...
  • Page 52 User’s Manual for Omega 12Patient Monitor 7.5 Changing ECG Settings Select ECG parameter window or waveform area  Enter “ECG Menu” page, as shown in Figure 7-4. Figure 7-4: ECG Menu 7.5.1 ECG Normal Setup In “ECG Menu” page, select “Normal Setup” tab to set: Color: Select the drop-down menu of “Color”...
  • Page 53 User’s Manual for Omega 12Patient Monitor Lead Set Select “Lead Set” drop-down menu, and toggle between 3 Leads and 5 Leads mode. The default setting is 5 Leads. HRSource Select “HR Source” drop-down menu, when lead set is 3 Leads, you can choose Lead I, Lead II or Lead III.
  • Page 54 User’s Manual for Omega 12Patient Monitor NOTE  ECG Cascade only supports the first row of ECG waveforms. Pace Detection Select “Pace Detection” drop-down menu and toggle between ON and OFF. The default setting is OFF. When “Pace Detection” is ON, the pace pulse markers “|” are shown on the ECG wave when a paced signal has been detected.
  • Page 55 User’s Manual for Omega 12Patient Monitor 7.6 ST Monitoring The ST segment is an interval between ventricular depolarization and ventricular repolarization. It is identified as the end of the QRS complex to the beginning of the T wave. ST monitoring is intended to monitor the patient's oxygen supply and myocardial function. ST segment analysis calculates ST segment elevations and depressions for a given lead.
  • Page 56 User’s Manual for Omega 12Patient Monitor Number Explanation Number Explanation ST Unit Lead Name ST Label ST Value ST parameters displayed in the ECG parameter area varies with the operating “Lead Set”: When 3-lead is used for monitoring, only one ST parameter value is displayed in ECG parameter area, No ST parameter area will appear;...
  • Page 57 User’s Manual for Omega 12Patient Monitor ST Source Select “ST Source” drop-down menu to set ST Source. When Lead Set is 3 Leads, Options are Lead I, Lead II and Lead III. The default setting is Lead II. When Lead Set is 5 Leads,Options are Lead I, Lead II, Lead III, Lead AVL, Lead AVR, Lead AVF, Lead V.
  • Page 58 User’s Manual for Omega 12Patient Monitor In “ECG Menu”, Select “ST Analysis” tab; Select corresponding setting page and then use the touchscreen to adjust the position of each point;  The ISO-point cursor (1) positions the isoelectric point relative to the R-wave peak. Position the ISO-point in the middle of the flattest part of the baseline (between the P and Q waves or in front of the P wave).
  • Page 59 User’s Manual for Omega 12Patient Monitor Arrhythmia analysis provides information on your patient's condition, including heart rate, PVC rate, rhythm, and ectopics. Healthcare professionals can use the analysis for patient treatment. 7.7.1 Safety Information WARNING  Arrhythmia may impact the Heart Rate. When patient with Arrhythmia is monitored, do not rely exclusively on the alarm messages based on HR value.
  • Page 60 User’s Manual for Omega 12Patient Monitor Irr. Rhythm Consistently irregular rhythm Ventricular Couplet Ventricular Premature Beats Bigeminy Trigeminy Tachycardia Bradycardia Missed Beats 7.7.3 Changing Arrhythmia Alarm Settings To change arrhythmia alarm settings, click “ECG Menu” select “ARRAlarm” tab Set the arrhythmia alarm for every arrhythmia condition according to your needs, as shown in Figure 7-12: Figure 7-12: Arrhythmia Alarm Setup Menu...
  • Page 61 User’s Manual for Omega 12Patient Monitor 7.8 ECG Troubleshooting This section lists the problems that might occur. If you encounter problems when using the monitor or accessories, check the table below for troubleshooting. If the problem persists, contact your service personnel. Problem Corrective Action 1.Check that electrodes are not detached or dry.
  • Page 62 User’s Manual for Omega 12Patient Monitor 1.Check that the ECG gain is not set too low. Adjust the gain as required. 2.Perform skin preparation again and re-place the electrodes. Low Amplitude ECG Signal 3.Check electrode application sites. Avoid bone or muscular area.

  • Page 63: Resp

    User’s Manual for Omega 12Patient Monitor 8 Resp 8.1 Description Respiration is measured by thoracic impedance method. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is calculated from these impedance changes, and a respiration waveform appears on the patient monitor screen.
  • Page 64 User’s Manual for Omega 12Patient Monitor 8.3 Resp Display Resp waveform area and parameter area are shown as below in Figure 8-1. Figure 8-1: Resp Parameter and Waveform Display Number Explanation Number Explanation Resp Label Alarm Limit Resp Gain Resp Rate（RR） Resp Waveform NOTE ...
  • Page 65 User’s Manual for Omega 12Patient Monitor 8.4.2 Placing Resp Electrodes As the Respiration measurement adopts the standard ECG electrode placement, you can use different ECG cables (3-lead, 5-lead). No additional electrodes are needed after ECG measurement. But the optimizing lead placement for Resp is essential. In clinical applications, some patients (especially neonates) expand their chests laterally, causing a negative intrathoracic pressure.
  • Page 66 User’s Manual for Omega 12Patient Monitor Don’t use it if electrode conducting gel has dried out. 8.5 Setting Resp Select Resp parameter area or waveform area  “Resp Menu” will pop up, as shown in Figure 8-2: Figure 8-2: Resp Setup Menu 8.5.1 Resp Normal Setup In “Resp Menu”, select “Normal Setup”...
  • Page 67 User’s Manual for Omega 12Patient Monitor 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 detailed information.

  • Page 68: Spo2

    SpO2 and pulse rate. This device is calibrated to display functional 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 on the module;...
  • Page 69 User’s Manual for Omega 12Patient Monitor  Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced current could potentially cause burns. The sensor may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. ...
  • Page 70 User’s Manual for Omega 12Patient Monitor  Interfering substances:  Intravascular dyes (such as indocyanine green, methylene blue, etc.)  Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb)and methemoglobin (MetHb)  Presence of certain dyes on the measured site, such as methylene and indigo carmine ...
  • Page 71 User’s Manual for Omega 12Patient Monitor (2) The bar graph is directly proportional to the pulse intensity and can reflect the filling state of blood. As an indication of signal integrity, there are 15 grids in total. When it is less than 3 grids, the signal is weak and the measurement result may be inaccurate.
  • Page 72 User’s Manual for Omega 12Patient Monitor 9.6 Changing SPO2 Setting Select SpO2 waveform area or parameter area  “SpO2 Menu”, as shown in Figure 9-2. Figure 9-2: SpO2 Menu 9.6.1 SpO2 Normal Setup Select “SpO2 Menu” page  select “Normal Setup” tab, to set: Color Select the drop-down menu for “Color”, 2 colors are available, as shown in Figure 9-2.
  • Page 73 User’s Manual for Omega 12Patient Monitor 9.6.2 SpO2 Alarm Setup Select “SpO2 Menu”  Select “Alarm Setup” tab, as shown in Figure 9-3. Figure 9-3: SpO2 Alarm Setup Menu You can set the following alarm parameters for SpO2 module: SpO2,PR,PI, (PI setting is enabled only when Masimo SpO2 module is used.
  • Page 74 User’s Manual for Omega 12Patient Monitor 1、NIBP cuff on the same limb as the SpO2 sensor. Change measured site if necessary. Pleth waveform size too low 2、PI value too low. Adjust the sensor position and connect to site with better perfusion. 3、Check sensor condition and sensor placement.

  • Page 75: Temp

    User’s Manual for Omega 12Patient Monitor 10 Temp 10.1 Temp Description Temperature of the human body is measured by the sensor that turns the temperature into an electrical signal, which is amplified and processed. Continuous temperature measurement uses thermistor method, based on the principle that the resistance of a thermistor changes with temperature.
  • Page 76 User’s Manual for Omega 12Patient Monitor 10.4 Temp Setting Select Temp parameter area “Temp Menu” will pop up, as shown in Figure 10-2. Figure 10-2: Temp Menu 10.4.1 Temp Normal Setup In “Temp Menu”  Select “Normal Setup” tab: Color Select “Color”...
  • Page 77 User’s Manual for Omega 12Patient Monitor Figure 10-3: Temp Alarm Setup Menu Temp alarm parameters are: T1, T2 and △T. Set T1, T2 and △T parameter according to your needs. 10.5 Temp Troubleshooting This section lists the problems that might occur. If you encounter problems when using the monitor or accessories, check the table below for troubleshooting.

  • Page 78: Nibp

    User’s Manual for Omega 12Patient Monitor 11 NIBP 11.1 NIBP Description This monitor uses the oscillometric method for measuring the non-invasive blood pressure (NIBP). It is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. Oscillometric devices use a blood pressure cuff to sense these oscillations that appear as tiny pulsations in cuff pressure.
  • Page 79 User’s Manual for Omega 12Patient Monitor  Avoid applying the cuff on the side of the mastectomy.  Cuff pressurization may cause temporary loss of the function of monitoring equipment used simultaneously on the same limb.  Kinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference and potentially resulting in injury to the patient.
  • Page 80 User’s Manual for Omega 12Patient Monitor coming from the artery  On an edematous extremity NOTE  The NIBP feature is not validated for pregnant, including preeclamptic patients use. 11.4 MeasurementMethods There are three methods of measuring NIBP:  Manual: measurement on demand. ...
  • Page 81 User’s Manual for Omega 12Patient Monitor Alarm Limits: The upper digits are systolic alarm range; the bottom digits are diastolic alarm range. Mean Pressure: Mean pressure obtained after the measurement and the real-time cuff pressure obtained during the measurement. 11.6 NIBP Measurement Preparation 11.6.1 NIBP Patient Preparation When taking routine resting blood pressure, ensure that: ...
  • Page 82 User’s Manual for Omega 12Patient Monitor Correcting the Measurement if Limb is not at Heart Level:  Add 0.9 mmHg (0.12 kPa) for each centimeter higher, or  Deduct 0.9 mmHg (0.12 kPa) for each centimeter lower. CAUTION  Improper NIBP cuff size or compression of the cuff may lead to measurement inaccuracy. ...
  • Page 83 User’s Manual for Omega 12Patient Monitor will continue the 2 measurement. The automatic NIBP measurement process will stop after 5 measurements. 4、During the measurement, Select NIBP “Stop” at any time to terminate measurement process. 11.8 Changing NIBP Settings Select the NIBP parameter area  “NIBP Menu” will pop up, as shown in Figure 11-2. Figure 11-2: NIBP Setup Menu 11.8.1 NIBP Normal Setup Select “NIBP Menu”...
  • Page 84 NIBP Module Choose Select “NIBP Module Choose”  Enter password (e.g., nbp…) to enable the drop-down menu  choose NIBP module type: Infinium, SunTechHuman or SunTechAnimal, the default setting is Infinium. 11.8.2 NIBP Alarm Setup In “NIBP Menu” window  Select “Alarm Setup” tab, as shown in Figure 11-3.
  • Page 85 User’s Manual for Omega 12Patient Monitor Figure 11-3: NIBP Alarm Setup Menu You can set NIBP parameters: SYS and DIA alarm limits according to patient category SYS Low Range DIA Low SYS High alarm DIA High alarm alarm limit alarm limit （mmHg）...
  • Page 86 User’s Manual for Omega 12Patient Monitor Figure 11-5: NIBP Tabular Trends 11.10 NIBP Maintenance 11.10.1 NIBP Leakage Test The NIBP leakage test checks the integrity of the system and of the valve. It is required at least once every two years or when you doubt the measured NIBP. Leakage Test must be performed by your service personnel.

  • Page 87: Ibp

    User’s Manual for Omega 12Patient Monitor 12 IBP 12.1 IBP Description IBP is performed when real-time monitoring of blood pressure changes is required in critically ill patients such as shock patients, some cardiac surgeries and other major procedures. Invasive blood pressure (IBP) is generally monitored for: arterial blood pressure (ABP), central venous pressure (CVP), pulmonary artery pressure (PAP), left atrial pressure (LAP), and intracranial pressure (ICP).
  • Page 88 User’s Manual for Omega 12Patient Monitor  For physiological and technical alarm message, please refer to Appendix C Alarm messages. 12.3 IBP Measurement 12.3.1 IBPDevice Connection Figure 12-1: IBP Device Connection Diagram 12.3.2 Setting up IBP Measurement. Plug the pressure cable into the IBP connector. Plug the other side of the pressure cable into the IBP module.
  • Page 89 User’s Manual for Omega 12Patient Monitor To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital policy (at least once per day). Zero whenever:  A new transducer or adapter cable is used. ...
  • Page 90 User’s Manual for Omega 12Patient Monitor 12.5 IBP Setting Select IBP waveform window or parameter area  “IBP Menu” pops up, as shown in Figure 12-3. Figure 12-3: IBP Menu 12.5.1 IBP1/IBP2 Setup In “IBP Menu” page  Select “IBP1/IBP2 Setup” tab to set: 1）...
  • Page 91 User’s Manual for Omega 12Patient Monitor 7） Zero IBP1 or IBP2 Select “Zero IBP1/IBP2” You can zero one channel at a time with selection Zero IBP1 or Zero IBP2. 8） Zero IBP1 & IBP2 Simultaneously Select “Zero IBP1& IBP2” to zero both of them. 12.5.2 IBP1/IBP2 Alarm Setup In “IBP Menu”...
  • Page 92 User’s Manual for Omega 12Patient Monitor 3、Flush and zero. 4、Replace the transducer. 1、Make sure that the transducer is vented to air, not to the patient, and try again. Zeroing failure 2、Rezero the transducer and don’t move the transducer and tubing when zeroing. 3、Replace the transducer if the rezeroing still fails.

  • Page 93: Etco2

    User’s Manual for Omega 12Patient Monitor 13 EtCO2 13.1 EtCO2 Description End-tidal CO2 or partial pressure (EtCO2) reflects pulmonary ventilation and also pulmonary blood flow. When no significant cardiopulmonary disease exists and V/Q ratio is normal, EtCO2 reflects PaCO2 (arterial blood carbon dioxide), with a normal EtCO2 value of 5% corresponding to 5KPa (38mmHg).
  • Page 94 User’s Manual for Omega 12Patient Monitor  Failure of operation: if the measurement or a sensor fails to respond as described, do not use it until the situation has been corrected by qualified personnel. 13.3 Measurement Influencing Factors The following factors may influence the accuracy of measurement: •...
  • Page 95 User’s Manual for Omega 12Patient Monitor temperature and a stable thermal condition. 3.Choose the appropriate airway adapter and connect it to the sensor head. The airway adapter clicks into place when seated correctly. 4. To zero the sensor: – Expose the sensor to room air and keep it away from all sources of CO2 including theventilator, the patient's breath and your own.
  • Page 96 User’s Manual for Omega 12Patient Monitor  Place the sensor and adapter close to the patient to avoid blockage in airway.  EtCO2 sensors are external module, thus please strictly adhere to the module manual for measurement operation. 13.6 EtCO2 Setup Select EtCO2 waveform area parameter area on monitoring screen ...
  • Page 97 User’s Manual for Omega 12Patient Monitor Select “Waveform Scale” drop-down menu to change the size of the CO2 waveform. You can choose “0-75mmHg” or “0-150mmHg”. EtCO2 Period Select “EtCO2 Period” drop-down menu to set EtCO2 Period for calculation and toggle between 1Breath,10s and 20s.
  • Page 98 User’s Manual for Omega 12Patient Monitor 13.6.2 EtCO2 Alarm Setup In “EtCO2 Menu” Page, select “Alarm Setup” tab, as shown in Figure 13-3.Set EtCO2 and awRR alarm value as you desired. Figure 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.
  • Page 99 User’s Manual for Omega 12Patient Monitor 13.8 CO2 Troubleshooting This section lists the problems that might occur. If you encounter problems when using the monitor or accessories, check the table below for troubleshooting. If the problem persists, contact your service personnel. Problem Corrective Method 1、Check whether the CO2 concentration of the...

  • Page 100: Bis

    User’s Manual for Omega 12Patient Monitor 14 BIS 14.1 Description Bispectral Index monitoring helps to monitor the level of consciousness of a patient under general anesthesia or sedation in the OR and ICU. By measuring the ECG signal, use of BIS monitors the patient’s brain activity to help reduce the incidence of awareness with recall during general anesthesia or sedation.
  • Page 101 User’s Manual for Omega 12Patient Monitor  The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.  Clinical judgment should always be used when interpreting BIS in conjunction with other available clinical signs.
  • Page 102 User’s Manual for Omega 12Patient Monitor NOTE  This monitor uses a component modular device in deriving the Bispectral index (BIS) purchased from Covidien. It is important to recognize this index is derived using solely that company’s proprietary technology. It is recommended that clinicians have reviewed applicable information on its utility and/or risks in published articles and literature/web site information from Covidien (www.covidien.com) or contact that company itself if they have clinical-based BIS questions relating to this module portion of the patient monitor.
  • Page 103 User’s Manual for Omega 12Patient Monitor BIS value, it may cause the BIS value or other Parameter not being displayed. The EMG numeric reflects the electrical power of muscle activity and high frequency artifacts. The larger the value, the greater the EMG interference: EMG >...
  • Page 104 User’s Manual for Omega 12Patient Monitor Figure 14-1: EEG Waveform Area and Parameter Area Number Explanation Number Explanation EEG Lead Label SQI Signal Strength Bar Graph BIS Waveform Display EMG Strength Bar Graph EEG Sweep Speed Related Parameter Value BIS Label Related Parameter Unit BIS Alarm Limits EEG Waveform Scale...
  • Page 105 User’s Manual for Omega 12Patient Monitor and impedance values.  Do not use the BIS sensor if the sensor gel is dry. To avoid dryout, do not open the pack until you are ready to use the sensor.  Since the BIS sensor is in close contact with the skin, Reuse may cause a risk of contamination.
  • Page 106 User’s Manual for Omega 12Patient Monitor Normal dual channel Quatro sensor for adults Extended sensor for adults Extend requiring long-term monitoring of brain activity Pediatric Sensors for pediatrics Demo Sample demonstration Simulator Simulation demonstration BIS Sensor Status The monitor can automatically identify the Sensor Status: Status Explanation Action...
  • Page 107 User’s Manual for Omega 12Patient Monitor the function by selecting “StartCheck”. NOTE  Make sure the patient’s skin is dry. A wet sensor or a salt bridge could result in erroneous BIS and impedance values.  Ensure that the BISx does not come into prolonged contact with your patient's skin, as it may generate heat and cause discomfort.
  • Page 108 User’s Manual for Omega 12Patient Monitor default speed is 12.5mm/s. The larger the value, the faster the wave sweeps. Display Select “Display” drop-down menu to set BIS waveform type for display. BISx is a dual-channel EEG signal monitoring device for unilateral cerebral hemisphere BIS monitoring. Waveform display options are EEG I, EEG II, and Trend.
  • Page 109 User’s Manual for Omega 12Patient Monitor 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 default notch filtering is OFF.
  • Page 110 User’s Manual for Omega 12Patient Monitor 14.7.2 BIS Alarm Setup In “BIS Menu” page  Select “Alarm Setup” tab to set BIS alarm according to your needs. 14.8 BIS Troubleshooting This section lists the problems that might occur. If you encounter problems when using the monitor or accessories, check the table below for troubleshooting.
  • Page 111 User’s Manual for Omega 12Patient Monitor 15 C.O. 15.1 C.O. Description The Cardiac Output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using a technique called thermodilution. This can be used to determine the flow rate of a system by introducing a cold solution into the system and measuring the resulting drop in temperature at a downstream site.
  • Page 112 User’s Manual for Omega 12Patient Monitor performed. The following are suggestions about technique that can help obtain accurate cardiac output:  The temperature of the injectate should always be 10℃ lower than blood temperature.  Inject solution rapidly and smoothly. ...
  • Page 113 User’s Manual for Omega 12Patient Monitor 15.6 C.O. Setup In “C.O. Measure” window Select “Setup” Enter “C.O. Setup”, as shown in Figure 15-2. You can set: Figure 15-2: C.O. Setup IT Source Select “IT Source” drop-down menu and toggle between Auto and Manual. The default setting is Auto.
  • Page 114 User’s Manual for Omega 12Patient Monitor 15.7 C.O. Troubleshooting This section lists the problems that might occur. If you encounter problems when using the monitor or accessories, check the table below for troubleshooting. If the problem persists, contact your service personnel. Problem Corrective Method C.O.

  • Page 115: Managing Patients

    User’s Manual for Omega 12Patient Monitor 16 Managing Patients 16.1 Patient Information Setup When you turn on the monitor and enters the normal screen, a prompt window will appear. Select "Create New Patient"  Enter the patient information according to instructions shown on screen.
  • Page 116 User’s Manual for Omega 12Patient Monitor Gender Set patient gender. The default setting is Male Birthday Set patient birthday. The default setting is 01/01/2020. Height cm Set patient height, the input range is 50～250cm. Weight kg Set patient weight, the input range is 1～300kg. Patient Type Set patient type: adult, pediatric or neonatal.
  • Page 117 User’s Manual for Omega 12Patient Monitor 16.4 Deleting Patient Information This monitor can save up to 20 patients’ information. When trying to save more than 20 patients’ information, 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"...

  • Page 118: Trends

    User’s Manual for Omega 12Patient Monitor 17 Trends 17.1 Description During the patient monitoring process, the monitor will periodically collect current measurement data of each parameter and save it on the internal memory for data review, to help understand the patient's condition and health trend over a period of time. This monitor can save up to 120 hours (5 days, 24 hours per day) of monitoring data for a single patient, and display trend in graphic or tabular form to give you a picture of how your patient's condition is developing.
  • Page 119 User’s Manual for Omega 12Patient Monitor Touch and select the parameter area on the right side of the screen  In the pop-up window, choose parameters for monitor display as you required. Trend Interval Select the Time Interval (“5s” button in Figure 17-1) in the bottom of the page  Set the Time Interval in the pop-up window as you required, there are 12 options: 5s, 10s, 20s, 30s, 40s, 50s, 1min, 2min, 4min, 6min, 8min, 10min.
  • Page 120 User’s Manual for Omega 12Patient Monitor the pages. There are 24 pages in total, you can Select on the bottom to scroll left or right to navigate through the trend database. Print/ Record By selecting the Print button, you can print out the currently displayed tabular trends. 17.4 View NIBP Tabular Trends Select “Trend Review”...
  • Page 121 User’s Manual for Omega 12Patient Monitor By selecting the “Print” button, you can print out the currently displayed data in NIBP tabular list. 17.5 Waveform Review Select “Trend Review” in the extended soft keys area to enter the Trend review page  Select “Waveform Review”...
  • Page 122 User’s Manual for Omega 12Patient Monitor Maximum Number of Records for Display Select the number value (on the right of “Number” label)  Set the maximum number of Waveform records displayed on the current page. Print/ Record By selecting the Print button in the bottom, you can print out the waveform, parameter value and event description corresponding to the selected time point.

  • Page 123: Patient History Data

    User’s Manual for Omega 12Patient Monitor 18 Patient History Data 18.1 Description Patient History Data refers to the monitoring data of previous sessions when a new monitoring session starts. This monitor can save the data of the last 8 monitoring sessions at most, and you can select to view each session in the form of GraphicTrends, Tabular Trends or Waveform Review, and export the historical data for analysis.
  • Page 124 User’s Manual for Omega 12Patient Monitor drive. 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 Review.

  • Page 125: Freezing Waveforms

    User’s Manual for Omega 12Patient Monitor 19 Freezing Waveforms 19.1 Description During patient monitoring, the freeze feature allows you to freeze the currently displayed waveforms on the screen so that you can have a close examination of the patient’s status. Besides, you can select any frozen waveform for thermal printing.
  • Page 126 User’s Manual for Omega 12Patient Monitor by thermal print. 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 at the frozen time are printed out by the thermal printer.

  • Page 127: Pharmacy Calculations

    Decisions on the choice and dosage of drugs administered to patients must always be made by the physician in charge.  Always cautiously check the input correctness and calculation plausibility. Infinium Medical Inc. is not liable for any consequences out of input and operation errors. 20.2...
  • Page 128 User’s Manual for Omega 12Patient Monitor Figure 20-1: Pharmacy Calculator Window 20.2.2 Using the Titration Table Titration table indicates the information regarding current drugs in use. Use the Titration Table to see at a glance what dose your patient would receive of a drug at different infusion rates. To see the Titration Table: in the extended soft keys area ...
  • Page 129 User’s Manual for Omega 12Patient Monitor 20.2.3 Drug Name You can select 15 drugs as you desired. Among them, you can customize drug name of A, B, C, D, E.  Oxytocin  Nitroglycerin  Nipride  Lidocaine  Isoproterenol ...
  • Page 130 User’s Manual for Omega 12Patient Monitor mEq/ml Infusion Time Infusion Time = Amount / Dosage Infusion Time Infusion Time（Weight-dependent） = Amount / （Dosage × Weight） (Weight-dependent) Infusion Rate ml/h Infusion Rate = Dosage / Concentration Infusion Rate Infusion Rate = Dosage × Weight / ml/h Concentration (Weight-dependent)

  • Page 131: Printing

    User’s Manual for Omega 12Patient Monitor 21 Printing 21.1 Use a Recorder This monitor uses the thermal recorder to print patient information, measurement numerics, waveforms (Up to 3 waveforms per printing) etc. 21.2 Start Printing You can manually start a recording or automatic recording will be triggered in certain conditions.
  • Page 132 User’s Manual for Omega 12Patient Monitor Printing example is shown in Figure 21-1. (For illustration only) Figure 21-1: Real-time Waveform Printing Report 21.4.2 Printing Procedure Select “Print” in soft keys area to start printing  Text on the soft key will change to “StopPrinting”...
  • Page 133 User’s Manual for Omega 12Patient Monitor The printing content includes information such as patient name, patient ID, alarm time, heart rate (HR), blood oxygen (SpO2), pulse rate (PR), NIBP (systolic blood pressure (SYS)/diastolic blood pressure (DIA)), respiratory rate (Resp), temperature (Temp), ST segment, alarm type, and hospital name.
  • Page 134 User’s Manual for Omega 12Patient Monitor 21.8 Loading Paper Press the door latch to open the recorder door. Remove the paper core. Place a new paper roll between the tabs of the paper holder. Make sure the paper unrolls from underneath the paper roll. Close the recorder door, make sure the new paper roll fits snugly into its housing and the paper end is feeding from the top.

  • Page 135: Internal Batteries

    User’s Manual for Omega 12Patient Monitor 22 Internal Batteries 22.1 Description The number of Lithium battery charge and discharge is more than 300 times (300-500 times, depending on the use of the situation). Battery lifespan depends on how frequent and how long it is use.
  • Page 136 User’s Manual for Omega 12Patient Monitor  Do not open batteries, heat above 60°C (140°F), incinerate batteries, or cause them to short circuit. They may ignite, explode, leak or heat up, causing personal injury. CAUTION  Take out the battery before the monitor is transported or will not be used for a long time. ...
  • Page 137 User’s Manual for Omega 12Patient Monitor 22.4.3 Battery Alarm If the battery capacity is too low, a technical alarm will be triggered and the [Battery Too Low] message displayed. At this moment, apply AC power to the patient monitor. Otherwise, the patient monitor will power off automatically in 15s.
  • Page 138 User’s Manual for Omega 12Patient Monitor NOTE  The operating time depends on the configuration and operation. For example, Screen brightness too high or monitoring NIBP repeatedly will all shorten the operating time of the batteries. 22.7 Storing a Battery When storing the battery, make sure the electrodes of the battery are not in contact with metal objects.

  • Page 139: Care, Cleaning And Maintenance

    User’s Manual for Omega 12Patient Monitor 23 Care, Cleaning and Maintenance 23.1 Description In this chapter we only describe cleaning and disinfection of the main unit. For the cleaning and disinfection of reusable accessories, refer to instructions for use of corresponding accessories. 23.2 Safety Information WARNING ...
  • Page 140 User’s Manual for Omega 12Patient Monitor 23.3 Cleaning Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of dust and sand in your place, the equipment should be cleaned more frequently. Before cleaning the equipment, consult your hospital’s regulations for cleaning the equipment.
  • Page 141 User’s Manual for Omega 12Patient Monitor 23.5 Maintenance WARNING  Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure, possible health hazards, and may endanger personal safety. ...
  • Page 142 User’s Manual for Omega 12Patient Monitor  Make sure that the recorder functions correctly and the recorder paper meets the requirements.  Make sure that the batteries meet the performance requirements.  Make sure that the patient monitor is in good working condition. ...

  • Page 143: Accessories

    User’s Manual for Omega 12Patient Monitor 24 Accessories All accessories listed in this chapter meet the requirements of IEC 60601-1-2 when used with a monitor. Accessory materials in contact with the patient have been tested for biocompatibility and verified to meet the requirements of ISO 10993-1. Detailed information on accessories can be found in the relevant accessory manual.
  • Page 144 User’s Manual for Omega 12Patient Monitor 24.2 SpO2 Accessories Name Model Type Remark Manufacturer 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 consumption canbe especially useful to clinicians, for example, clinicians performing photodynamic therapy.

  • Page 145: A Specifications

    User’s Manual for Omega 12Patient Monitor A Specifications A.1 Safety Specifications A.1.1 Classifications The patient monitor is classified, according to IEC60601-1: Type protectionagainst electricalshock CF：ECG、NIBP、TEMP、IBP、C.O. Degree of protection against electrical shock BF：SpO2、ETCO2、BIS Mode of operation Continuous Degree protectionagainst IPX2 harmfulingress of water A.1.2 Environmental Specifications Temperature（℃）...
  • Page 146 User’s Manual for Omega 12Patient Monitor A.2 Power Supply Specifications A.2.1 External AC Power Input Voltage 100 ~ 240V Input Current 1.3 ~ 0.5A Input Line Frequency 50/60 Hz A.2.2 Battery W ×D × H 145mm × 64mm×21.5mm Weight 340g Type Lithium-ion battery, rechargeable Rated Voltage...
  • Page 147 User’s Manual for Omega 12Patient Monitor Battery Status Indicator 1（green） A.3.4 Interface Power 1 AC power connector Ethernet Port 1 1000M Ethernet port 2 USB2.0 port HDMI Port 1 HDMI 1.4 port Equipotential End WIFI Standard IEEE 802.11 a/b/g/n Bluetooth Standard BT2.0 &...
  • Page 148 User’s Manual for Omega 12Patient Monitor Default setting is 2. 24H/12H format supported: 24H: YYYY/MM/DDHH:MM System Time 12H: YYYY/MM/DDH:MM AM/PM Turn on automatic synchronization, when the monitor is connected to WLAN. Time is automatically synchronized with network time. USBKeyboard USBMouse USB Flash Disk USB Extension ...
  • Page 149 User’s Manual for Omega 12Patient Monitor Configuration Export/Import IPv4 address supported, DHCP and Static IP supported. Ethernet Setup The system default is DHCP. WIFI SSID Scanning WIFI non-encryption/encryption connection supported, security certificates are:  WPA-PSK（recommended） WIFI  WPA2-PSK.recommended）  Once connected, the system will save the password and connect tothe WIFI automatically.
  • Page 150 User’s Manual for Omega 12Patient Monitor Data Communication Searching and remote view patient monitors within the same network View Other Monitored are supported Patients PatientMonitor ←→ PatientMonitor 1、 HL7 two-way communication supported 2、 HL7 patient management supported Health Level 7 3、...
  • Page 151 User’s Manual for Omega 12Patient Monitor Common Mode Rejection Ratio >90dB (With Notch Off) Diagnostic mode: Notch is 50/60Hz, nonadjustable Notch Monitor and surgical mode:50Hz/60 Hz/OFF, manual adjustment Differential Input Impedance ≥5MΩ Accuracy of Reappearing Input Use A and B methods based on EC13 or IEC60601-2-27 Signal to determine system total error and frequency response.
  • Page 152 User’s Manual for Omega 12Patient Monitor In compliance with the requirements in Clause 4.1.2.1 d)ofANSI/AAMI EC13-2002, the following method is used: HR Averaging Method the 4 most recent RR intervals are averaged to compute the HR. The HR value displayed on the monitor screen is updated everysecond.
  • Page 153 User’s Manual for Omega 12Patient Monitor Bigeminy（BGM） Trigeminy（TGM） Tachycardia（TAC） Bradycardia（BRD） Missed Beat（MIS） Alarm Limit Range (Low limit + 2) ~300 bpm Default value: HR Alarm High 130 bpm (Adult) 160bpm (Pediatric) 200bpm (Neonate) 15~ (high limit - 2) bpm Default value: HR Alarm Low 50bpm (Adult) 75bpm (Pediatric)
  • Page 154 User’s Manual for Omega 12Patient Monitor (Low limit + 2) ~120 rpm RR High Default value: 30rpm 0~ (high limit -2) rpm RR Low Default value: 6rpm A.5.3 Temp Temp Standard ISO 80601-2-56:2018 Measurement method Thermal Resistance Measurement range 0℃~50℃（32℉~122℉） Resolution 0.1℃...
  • Page 155 Infinium module, Nellcormodule, Masimomodule Alarm Limit Range (Low limit + 1) ~100% SpO2 Alarm High Infinium/Nellcor module: Default value: 99% Masimomodule: Default value: 99.9% 0~ (high limit - 1) % SpO2 Alarm Low Infinium/Nellcor module: Default value: 85% Masimomodule: Default value: 85.0%...
  • Page 156 User’s Manual for Omega 12Patient Monitor Refreshing rate Low Perfusion Conditions Pulse Rate Measurement Range 20bpm~250bpm Resolution 1bpm Accuracy 20bpm~250bpm: ±3bpm Masimo Module Measurement Range 0%~100% Resolution 0.1% Adult/Pediatric70%~100%: ≤±2% Accuracy Neonate70%~100%: ≤±3% 1%~69%: Not specified Refreshing rate Low Perfusion Conditions 0.02%~20% Pulse Rate Measurement Range...
  • Page 157 70mmHg (Pediatric) 60mmHg (Neonate) 10~ (high limit - 5) mmHg Default value: Dia Low 50mmHg (Adult) 40mmHg (Pediatric) 20mmHg (Neonate) Infinium Module Standard ISO80601-2-30:2019 Measurement Method Upper arm, Oscillometry Mode of Operation Manual, Auto and STAT Max Measurement Time 180s (Adult/Pediatric)
  • Page 158 User’s Manual for Omega 12Patient Monitor 90s (Neonate) Static Pressure Measurement 0~300mmHg Range Accuracy ±3mmHg Adult: SYS: 40mmHg~270mmHg DIA: 10mmHg~210mmHg Pediatric: Dynamic Pressure SYS: 40mmHg~200mmHg Measurement Range DIA: 10mmHg~150mmHg Neonate: SYS: 40mmHg~135mmHg DIA: 10mmHg~95mmHg Max mean error: ±5mmHg Dynamic Pressure Accuracy Max standard deviation: 8mmHg Resolution 1mmHg...
  • Page 159 User’s Manual for Omega 12Patient Monitor DIA: 20mmHg~100mmHg Dynamic Pressure Accuracy ±3mmHg Resolution 1mmHg Software Overpressure Adult/Pediatric: 300mmHg±10mmHg Protection Neonate: 150mmHg±10mmHg PR Measurement Range 30~220bpm PR Accuracy 2% or ±3bpm, whichever is greater A.5.6 IBP General Specification Standard IEC 60601-2-34:2011 Measurement Method Direct invasive measurement Measurement Range...
  • Page 160 User’s Manual for Omega 12Patient Monitor Default value: 90mmHg -30~ (high limit - 2) mmHg PA Alarm Low Default value: 60mmHg CVP/RAP/LAP/ICP (Low limit + 2) ~60mmHg Alarm High Default value: 30mmHg CVP/RAP/LAP/ICP -30~ (high limit - 2) mmHg Alarm Low Default value: 10mmHg A.5.7 C.O.
  • Page 161 User’s Manual for Omega 12Patient Monitor 在 0 - 69mmHg: 0.1mmHg Co2 Resolution 在 70 - 150mmHg: 0.25mmHg 0 - 40mmHg: ±2mmHg 41 - 70mmHg: ±5% 71 - 100mmHg: ±8% Accuracy* 101 - 150mmHg: ±10% respiration rate> 80/min: ±12% *NOTE: the above data is based on gas temperature of 25℃. Short-term drift:<...
  • Page 162 User’s Manual for Omega 12Patient Monitor EEG General Specification Standard IEC 60601-2-26:2012 Patient Leakage Current <=10μA (AC: 110V) Calibration Signal 1mV (peak to peak value） Differential Input Impedance >15MΩ @ 10 Hz Max. DC Input Offset Voltage ±320 mV Input Protection Against defibrillation (5kV) and electrosurgery Common Mode Rejection Ratio >...

  • Page 163: B Factory Defaults

    User’s Manual for Omega 12Patient Monitor B Factory Defaults Factory Default Settings B.1 ECG, Arrhythmia, ST B.1.1 ECG Setup ECG Setup Factory Default Settings Alarm ON/OFF Adult 130bpm Alarm High Pediatric 160bpm Neonate 200bpm Adult 50bpm Alarm Low Pediatric 75bpm Neonate 100bpm Alarm Level...
  • Page 164 User’s Manual for Omega 12Patient Monitor Medium Medium B.1.3 ST Segment Setup Item Factory Default Settings ST Alarm Mode Real-time Alarm ON/OFF Alarm High 0.30mV ST-I, ST-II, ST-III, ST-aVR Alarm Low -0.30mV ST-aVL, ST-aVF, ST-V Alarm Level Medium Alarm Record ST Analysis ST Segment Auto...
  • Page 165 User’s Manual for Omega 12Patient Monitor B.3 SpO2 Setup Item Factory Default Settings Alarm ON/OFF Alarm High SpO2 Alarm Low Alarm Level Medium Alarm Record Alarm ON/OFF Adult 130bpm Alarm High Pediatric 160bpm Neonate 200bpm Adult 50bpm Alarm Low Pediatric 75bpm Neonate 100bpm...
  • Page 166 User’s Manual for Omega 12Patient Monitor B.5 NIBP Setup Item Factory Default Settings Alarm ON/OFF Adult 160mmHg Alarm High Pediatric 120mmHg Neonate 90mmHg NIBP-SYS Adult 90mmHg Alarm Low Pediatric 70mmHg Neonate 40mmHg Alarm Level Medium Alarm Record Alarm ON/OFF Adult 90mmHg Alarm High Pediatric...
  • Page 167 User’s Manual for Omega 12Patient Monitor Alarm ON/OFF Alarm High 90 mmHg Alarm Low 60 mmHg IBP-DIA Alarm High 75 mmHg Alarm Low 45 mmHg Alarm Level Medium Alarm Record Alarm ON/OFF CVP, RAP Alarm High 30 mmHg IBP-MAP LAP, ICP Alarm Low 10 mmHg Alarm Level...
  • Page 168 User’s Manual for Omega 12Patient Monitor B.8 EtCO2 Setup Item Factory Default Settings Alarm ON/OFF Alarm High EtCO2 Alarm Low Alarm Level Medium Alarm Record Alarm ON/OFF Adult Alarm High Pediatric Neonate awRR Adult Alarm Low Pediatric Neonate Alarm Level Medium Alarm Record Color...
  • Page 169 User’s Manual for Omega 12Patient Monitor B.9 BIS Setup Item Factory Default Settings Alarm ON/OFF Alarm High Alarm Low Alarm Level Medium Alarm Record Color Speed 25mm/s Display EEG1 Parameter1 Parameter2 Scale 50μV Smoothing Rate Filter Auto Impedance Inspection...

  • Page 170: C Alarm Messages

    User’s Manual for Omega 12Patient Monitor C Alarm Messages C.1 Physiological Alarm Messages General Physiological Alarm Default Alarm Messages Cause and Solution Level XX value has risen above the high alarm limit XXX Too High Medium or fallen below the low alarm limit. Check the patient’s condition and check if the patient XXX Too Low Medium...
  • Page 171 User’s Manual for Omega 12Patient Monitor ECG Lead LA Off detached from the patient or the lead wire has become ECG Lead RA Off disconnected from the adapter ECG Lead LL Off cable. Check the connections of ECG Lead V Off the electrodes andleadwires.
  • Page 172 User’s Manual for Omega 12Patient Monitor condition and change the cuff application site. The measured NIBP value is not NIBP Overrange within the specified range. Check the patient’s condition. NIBP Excessive Motion Please keep quiet and remeasure. NIBP airway occluded. Check the airway and NIBP Overpressure measure again.If...
  • Page 173 User’s Manual for Omega 12Patient Monitor Check the CO2 connections. After sensor’stemperature EtCO2 Zero Failed becomes stabilized, perform a zerocalibration again. EtCO2 Overrange Check, clean or replace the EtCO2 Airway Adapter Error adapter. EtCO2 Pump Life Expired Replace the pump. BIS Sensor Expired Replace the sensor.

  • Page 174: D Emc And Radio Regulatory Compliance

    User’s Manual for Omega 12Patient Monitor D EMC and Radio Regulatory Compliance The product is in radio-interference protection class A in accordance with EN55011. The product complies with the requirement of standard EN60601-1-2:2007“Electromagnetic Compatibility – Medical Electrical Equipment”. NOTE  Using accessories, transducers and cables other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the patient monitoring equipment.
  • Page 175 User’s Manual for Omega 12Patient Monitor Resp Measurement Range: 0~120rpm Temp Measurement Range: 0~50℃ Measurement Range: 30~250bpm Display 12.5-inch multi-colored display, Resolution: 1366*768 Operation method Use touchscreen Alarm Indicator Audio alarm, Lamp alarm Data Communication Ethernet supported AC power: 100~220V, 50/60Hz, 1.3~0.5A Power Supply DC power: Battery power supplied 10.89V/5200mAh Lithium chargeable battery...
  • Page 176 User’s Manual for Omega 12Patient Monitor Guidance and Declaration - Electromagnetic Immunity The device is suitable for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Electromagnetic Environment - Immunity Test IEC 60601 Test Level...
  • Page 177 User’s Manual for Omega 12Patient Monitor Guidance and Declaration - Electromagnetic Immunity The device is suitable for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation...
  • Page 178 User’s Manual for Omega 12Patient Monitor and 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 and TV broadcasters cannot be accurately predicted theoretically. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be conducted.
  • Page 179 User’s Manual for Omega 12Patient Monitor Radio Management Compliance RF Parameter Project IEEE 802.11b/g/n (2.4G) IEEE 802.11b/g/n(HT20): 2412MHz to 2462MHz Operating Frequency IEEE 802.11n(HT40): 2422MHz to 2452MHz IEEE for 802.11b: DSSS(CCK, DQPSK, DBPSK) IEEE for 802.11g :OFDM(64QAM, 16QAM, QPSK, BPSK) Modulation IEEE for 802.11n(HT20 and HT40) : OFDM (64QAM, 16QAM, QPSK,BPSK)
  • Page 180 User’s Manual for Omega 12Patient Monitor FCC WARNING Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause...
  • Page 181 User’s Manual for Omega 12Patient Monitor 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: 1-727-531-8436 Infinium Medical Inc.

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