User Manual FCC ID: ZLZ-EPM Patient Monitor ePM 15M, ePM 12M, ePM 10M, ePM 15, ePM 12, ePM 10 Mindray Shenzhen Mindray BIO-Medical electronics Co.,LTD.
Intellectual Property Statement Shenzhen Mindray BIO-Medical electronics Co.,LTD.(hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information.
Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to the product. If you have any question, please contact Mindray. This manual is an integral part of the product.
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. NOTE • 1.1.1 Provides application tips or other useful information that does not involve patient or user risk.
• • • • • 1.1.2 Do not rely exclusively on the audible alarm system for patient monitoring. Turning the alarm volume to a low level or off may result in a hazard to the patient. Always keep the patient under close surveillance. Alarm settings should be customized according to patient situations. Do not place the equipment or accessories in any position that might cause it to fall on the patient. Do not start or operate the equipment unless the setup was verified to be correct.
1.1.3 Notes NOTE • • • • • • • • • • 1.2 The equipment software copyright is solely owned by Mindray. No organization or individual shall resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission. Put the equipment in a location where it can be easily viewed and operated. The equipment uses a mains plug as isolation means to the mains power. Do not locate the equipment in a place difficult to access the mains plug.
Symbol Description Symbol Description Stop USB IBP zero key NIBP start/stop Calibration Unlocking Menu Power On/Off Graphical record Gas outlet Gas inlet Output Input/output Pushing prohibited Non-ionizing electromagnetic radiation Authorised representative in the European Community Dispose of in accordance to local requirements Conforms to ANSI Std. ES60601-1, IEC Std. 60601-1-8, IEC Std. 60601-2-25, IEC Std. 60601-2-26, IEC Std. 606012-27, IEC Std. 80601-2-30, IEC Std.
2 Equipment Introduction 2.
2.3 System Components The monitor consists of the main unit, display, external modules, input devices and output devices. NOTE • 2.3.1 The monitor may not include all these components. Contact the local service personnel for available components. Main Unit The main unit processes data from modules. 2.3.1.
(8) (9) 2.3.1.2 ◆ On: when the AC power is connected. ◆ Off: when the AC power is not connected. Battery indicator ◆ Yellow: the battery is being charged. ◆ Green: the battery is fully charged. ◆ Flashing green: the monitor operates on battery power. ◆ Off: no battery is installed, or the battery is malfunctioning, or the monitor is powered off and no power is connected. Power switch ◆ Pressing this switch turns on the monitor.
2.3.1.3 Right View (1) (2) (1) Handle (2) Recorder 2.3.1.4 Rear View (1) (2) (1) (3) (4) (5) (6) (7) Alarm lamp When a physiological alarm or technical alarm occurs, this lamp lights and flashes corresponding with the alarm priority: (2) (3) ◆ High priority alarms: the lamp quickly flashes red. ◆ Medium priority alarms: the lamp slowly flashes yellow. ◆ Low priority alarms: the lamp lights in cyan without flashing.
(4) Network Connector It is a standard RJ45 connector which connects the monitor to the central monitoring system (CMS) or other network devices. (5) USB connectors It connects USB devices, for example the barcode reader. (6) VGA Connector It connects It connects a external display, which extends the display capability of your monitor. The contents displayed on the external display screen accords with those displayed on the monitor screen.
(1) Setup hard key: enters or exits the IBP Setup menu. (2) Zero hard key: enters the Zero IBP menu. (3) Module status indicator (4) 2.3.3 ◆ On: the module works properly. ◆ Flashing: the module is initializing. ◆ Off: the module is not connected or the module fails. Patient cable connectors Input Devices The monitor allows data entry through touchscreen, remote controller, hardkey and barcode reader. You can only use Mindray specified input devices. 2.3.
3 Getting Started 3.1 Equipment Preparation Safety Information WARNING • • • Use only installation accessories specified by Mindray. Connect only approved devices to this equipment. Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment).
3.2.1 Unpacking and Checking Before unpacking, examine the packaging carefully for signs of damage. If any damage is detected, contact the carrier, distributor, or Mindray. 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 damage. Contact Mindray in case of any problems. 3.2.
3.3.2 Connecting the Input Devices Connect the barcode reader to the USB port if necessary. 3.3.3 Connecting the Parameter Module To connect the parameter module, follow this procedure: 3.3.4 1. Push the module rack door open, and then push it until you hear a click. 2. With the module properly oriented, align the module insertion guide slot with the module rack insertion guide. Push the module into the module rack until you hear a click. 3.
CAUTION • 3.4 When removing the module, be careful not to drop it. Always support with one hand while pulling out with the other. Turning on the Monitor Before beginning measurements, turn on the monitor. Perform the following inspections: 1. Check the monitor and modules for any mechanical damage. Make sure that all external cables, plug-ins and accessories are properly connected. 2. Connect the power cord to the AC power source. Pressing the power switch turns on the monitor. CAUTION • • 3.
Select the Enter key ■ 3.5.3 to confirm the entry and close the on-screen keyboard. Using the Barcode Reader The monitor supports both a linear (1D) barcode reader and two-dimensional (2D) barcode reader. The barcode reader is connected to the monitor’s USB connector. If you are using the Mindray custom 2D barcode reader (Model HS-1R or HS-1M), before using the it for the first time, clear old data formats and configure the barcode reader. NOTE • 3.5.3.
3.6.1 (1) Patient information area: displays patient information, including patient category, gender, department, room number, bed number, and so on. The displayed patient information is configurable. Selecting this area enters the Patient Management menu. For more information, see 5.3 Managing Patient Information. (2) The current configuration (3) Technical alarm information area: displays prompt messages on the above; displays technical alarm messages at the bottom.
Symbol 3.6.2 Description Symbol Description Alarms are acknowledged and the alarm system is reset. The battery is working correctly. The green portion represents the remaining charge. The battery has low power and needs to be charged. The battery has critically low charge and needs to be charged immediately. Otherwise, the monitor will soon automatically shut down soon. The battery is being charged. No battery is installed.
3.6.3.1 Available Quick Keys The following table shows available quick keys. Symbol 3-8 Label Function Main Menu Symbol Label Function Enters the main menu. More Shows more quick keys. Alarm Setup Enters the Alarm dialog. Alarm Reset Acknowledges ongoing alarms and reset the alarm system. Audio Pause Pauses alarm tone. Discharge Patient Enters the Discharge Patient dialog. Review Enters the Review dialog. Standby Enters Standby mode.
Symbol 3.6.3.2 Label Function Volume Symbol Label Function Enters the Volume dialog. Freeze Freezes waveforms. Calculations Enters the Calculations dialog. Load Config Enters the Load Config dialog. Print Starts printing a real-time report. Record Starts/Stops a recording. ECG Lead/Gain Enters the ECG Lead/Gain dialog. Call Help Sends the Call Help signal over the network. GCS Enters the GCS dialog. EWS Enters the EWS screen.
3.7.2.1 Entering Privacy Mode To enter Privacy mode, choose either of the following ways: ■ Select the Privacy Mode quick key → select OK. ■ Select the Main Menu quick key → from the Display column select Privacy Mode → select OK. The monitor has the following features after entering Privacy mode: ■ The screen turns blank. ■ Except for the low battery alarm, the monitor inactivates alarm tones and alarm lights for all other alarms.
3.7.3.2 Exiting Night Mode To cancel Night mode, follow this procedure: 1. Select the Night Mode quick key, or select the Main Menu quick key → from the Display column select Exit Night Mode. 2. Select OK. NOTE • • 3.7.4 If the monitor is connected to the CMS, it automatically exits Night mode when being disconnected from the CMS. The monitor resume the previous settings after exiting Night mode. Standby Mode Standby mode can Temporarily stop patient monitoring without switching off the monitor. 3.
3.8 Configuring the Monitor Configure the monitor before putting it in use. 3.8.1 Setting the Date and Time To set the system time, follow this procedure: 1. Select the Main Menu quick key → from the System column select Time. 2. Set Date and Time. 3. Set Date Format. 4. Switch off 24 Hour Time to use the 12-hour mode. 5. Switch on Daylight Savings Time to use daylight savings time.
3.9 General Operation This section describes the operations that are generally used when monitoring a patient. 3.9.1 Switching On or Off a Parameter You can also manually switch on or off a parameter when its module is connected. If setting parameter switches is not password protected, follow this procedure to set parameter switches: 1. 2. Access Parameters On/Off in either of the following ways: ◆ Select the Screen Setup quick key → select the Parameters On/Off tab.
■ Select the Main Menu quick key → from the Parameters column select Setup → select the desired parameter. NOTE • 3.9.5 In this manual, the first method is normally used to enter the setup dialog. But you can use any method you prefer. Changing Measurement Colors Set the color of measurement values and waveforms for each parameter by following this procedure: 3.10 1. Select Main Menu quick key → from the Parameters column select Parameter Color. 2.
3.11 Checking Software Licenses To run the following functions in the monitor, software licenses are required: ■ Early Warning Score (EWS) ■ ECG 24H Summary To check the licenses, select the Main Menu quick key → select License → Local. To install the licenses, follow this procedure: 3.12 1. Connect the USB drive with the licenses in to the monitor’s USB connector. 2. Select the Main Menu quick key →select License → select External. 3. Select Install.
3.15 Disconnecting the Wireless Network To disconnect the wireless network manually, follow this procedure: 1. Swipe the screen from top down with a single finger. 2. Select . To reconnect the wireless network after it is disconnected manually, follow this procedure: 3.16 1. Swipe the screen from top down with a single finger. 2. Select . Turning Off the Monitor Before turning off the monitor, perform the following check: 1. Ensure that patient monitoring has been completed. 2.
4 User Screens The monitor provides different user screens to facilitate patient monitoring in different departments and clinical applications. 4.1 Choosing a Screen The monitor enters the normal screen after it is powered on. The normal screen is most frequently used for patient monitoring. To select other screens, follow this procedure: 1. 2. 4.2 Access the Choose screen tab in either of the following ways: ◆ Select the Screen Setup quick key.
4.3 The Big Numerics Screen The Big Numerics screen displays parameter numerics in big font size. The Big Numerics screen displays measurement values and waveforms of up to six parameters. You can configure the parameters and their layout on the big numeric screen. 4.3.1 Entering the Big Numerics Screen To enter the big numerics screen, choose any of the following ways: 4.3.2 ■ Swipe left or right on the touchscreen with two fingers to switch to the big numerics screen.
4.4.2 The Display of Minitrends Screen The following figure shows the minitrends screen. Your display may be configured to look slightly different. (3) (1) (4) (5) (6) (2) 4.4.3 (7) (1) Scale (2) Routine Vital/Baseline button. If the department is set to OR, then the Baseline button is available. For other departments, the Routine Vital button is available.
4.4.5 Setting the Minitrend Length To set the Minitrend length, follow this procedure: 4.4.6 1. Enter the Minitrends screen. 2. Select the Setup button. 3. Set the Minitrend Length. Setting the Alarm Statistics Switch The Minitrends screen can be configured to display the statistic number of physiological alarm in its lower half screen. To set the alarm statistics switch, follow this procedure: 4.4.7 1. Enter the Minitrends screen. 2. Select the Setup button. 3.
4.4.9 Aldrete Score Select Aldrete Score to show the latest score and scoring time. To understand the current patient status, select a score for each item and then select OK to get a new score. WARNING • 4.5 The Aldrete score and recommendation is for reference only. Clinicians must make the decision of discharging the patient from recovery according to the patient’s actual condition. The OxyCRG Screen The OxyCRG screen is the default user screen when the neonatology department is selected.
4.5.4 Setting OxyCRG Parameters Select parameter trends or compressed waveform to set parameters and the compressed waveform you want to display. The selected parameters will be used for ABD event calculation. 4.5.5 Setting the Threshold of ABD Events Select any parameter trend or the compressed waveform to perform the following setup: ■ Set the threshold of ABD events. ■ Set Event Storage Format: ◆ 1 min+3 min: stores data one minute before and three minutes after the event.
4.6.2 The Display of SpO2 Screen The following figure shows the SpO2 screen. Your display may be configured to look slightly different. (1) (5) (2) (3) (4) 4.6.3 (6) (1) Tabular trend: displays trends of SpO2, PR, and PI. (2) SpO2 statistics area: displays the statistics data of each SpO2 section. (3) Temp area: displays Temp measurements and alarm limits. (4) NIBP area: displays NIBP measurements and alarm limits. (5) SpO2 area: displays measurements and alarm limits of PR, and PI.
4.7.1 Entering the Remote View Screen To enter the Remote View screen, choose one of the following ways: 4.7.2 ■ Select the Remote View quick key. ■ Select the bed at the alarm watch tile on the main screen. For more information, see 4.7.10.2 Displaying the Alarm Watch Tile on the Main Screen. ■ Select the Screen Setup quick key → select the Primary Display tab or Secondary Display tab (as available)→ select the Choose Screen tab → select Remote View.
WARNING • 4.7.3 The data presented in the Remote View screen has a delay. Do not rely on this screen for real time data. Adding a Bed After adding the desired remote devices, then the alarms from these devices can be viewed on the monitor. To add a remote device, follow this procedure: 1. Enter the Select Bed dialog. To do so, choose either of the following ways: ◆ In the Remote View screen, select Select Bed. For more information, see 4.7.1 Entering the Remote View Screen.
4.7.8 Resetting Alarms for Remote Devices You can reset the alarms on the remote devices by selecting Alarm Reset in the Remote View screen. This function needs to be enabled. For more information, see 25.3.5.1 Resetting Alarms for Remote Devices. 4.7.9 Selecting Beds By Care Group If configured, the monitor automatically selects beds in the same care group during the shift of care groups in the CMS. To enable this function, follow this procedure: 1. Enter the Select Bed window.
4.7.10.2 Displaying the Alarm Watch Tile on the Main Screen To configure the alarm watch tile to be displayed on the monitor’s main screen, follow this procedure: 1. Select the Main Menu quick key → from the Display column select Choose Screen to enter the Screen Setup dialog. 2. Select the Tile Layout tab. 3. Select the numeric area where you want to display the alarm watch tile, and then in the drop-down list, select Alarm Watch → A-W1or A-W2.
5 Managing Patients 5.1 Starting Monitoring a Patient After turning on the monitor, follow this procedure to monitor a patient: 5.2 1. Admit the patient. 2. Check patient settings. Make sure that alarm limits, patient category and paced status, and so on, are appropriate for the patient. Change them if necessary. 3. Perform desired measurements. For more information, see corresponding measurement chapters.
NOTE • 5.2.3 The monitor will reload the configuration if you changed the patient category. Loading Patient Information from the CMS If the monitor is connected to the central monitoring system (CMS). You can load patient information from the CMS to the monitor. To do so, follow this procedure: 1. Enter the Find Patient dialog in either of the following ways: ◆ Select the Main Menu quick key → from the Patient Management column select Find Patient.
4. 5.4 Select Export Data. Deleting Patient Data To delete the data of discharged patients, follow this procedure: 1. 5.5 Access the Discharged Patients dialog box by either of the following ways: ◆ Select the Discharged Patients quick key. ◆ Select the Main Menu quick key → from the Patient Management column select Discharged Patients. 2. From the patient list select desired patients. 3. Select Delete. Stopping a Parameter Measurement To stop monitoring a parameter, follow this procedure: 5.
6 Interfacing with External Devices 6.1 BeneLink Introduction BeneLink module is intended for connecting external devices, such as ventilators and anesthesia machines, to the monitor. It allows information (patient data, alarms, etc.) from external devices to be displayed, saved, recorded, or printed through the monitor. If the monitor is connected with the CMS or eGateway, information from external devices can also be transmitted to the CMS or eGateway.
6.3 Differences in Displayed Values In certain cases, there may be differences between the numerics displayed on the monitor and those on external devices. The table below lists some situations and possible reasons. Situation Possible Reasons Some parameter values are displayed as invalid values on the monitor. The patient monitor and the external device may have different parameter configuration or displaying range of values.
To connect an external device, follow this procedure: 1. Insert the BeneLink module into the module rack. 2. Connect the ID adapter that matches the external device to the BeneLink module with an RJ45 connecting cable. 3. Plug the ID adapter into the RS232 port on the external device. Some external devices may have ports incompatible with the ID adapter. In this case, a serial port adapting cable is required. 4.
■ For the parameters measured and controlled by the external device, measurements and settings are displayed after parameter labels, and settings are also enclosed in parenthesis. For example, PEEP 18 (20), in which PEEP is parameter label, 18 is the measurement, and (20) is the setting. NOTE • 6.6 Parameters in the Integrated Devices screen are displayed in the order as shown in the selection dialog.
In the main screen, the numeric area of some parameters from an external device, for example the +Paw parameter, can display multiple parameters. To select parameters for display, follow this procedure: 6.6.4 1. Select the numeric area of the parameter from the external device. 2. Select the Select Parameter tab. 3. Select the parameters for display. Setting Units for Parameters from External Devices To set units for parameters from external devices, follow this procedure: 6.6.5 1.
7 Alarms 7.1 Alarm Introduction This chapter describes alarm functions and alarm settings. 7.2 Alarm Safety Information WARNING • • • • • • • A potential hazard can exist if different alarm presets and default configuration settings are used for the same or similar equipment in the same care area, for example an intensive care unit or cardiac operating room. If the monitor is connected to the central monitoring system (CMS) or other monitors, alarms can be presented and controlled remotely.
7.3.3 ■ Low priority alarms: indicate a discomfort condition, a device malfunction, or an improper operation. Low priority alarms require you to be aware of this condition. ■ Messages: provides additional information on the patient or the equipment. Alarm Indicators When an alarm occurs, the monitor indicates it through visual or audible alarm indications. For more information, see the following table.
7.3.4 Alarm Status Symbols Apart from the alarm indicators as described in 7.3.3 Alarm Indicators, the monitor uses the following symbols to indicate the alarm status: 7.4 Alarm pause: indicates that all the alarms are paused. Alarm off: indicates that individual measurement alarms are turned off or the system is in the alarm off status. Audio pause: indicates that audible alarm tones are paused. Audio off: indicates that audible alarm tones are turned off.
7.6 Changing Alarm Settings Alarms settings can be changed by selecting Main Menu and choosing from the list in the Alarm column. 7.6.1 Setting Parameter Alarm Properties To set parameter alarm properties, follow this procedure: 1. 2. Access the Limits page in either of the following WAYS: ◆ Select the Alarm Setup quick key. ◆ Select the Main Menu quick key → from the Alarm column select Limits. Select a parameter tab and set alarm properties as desired.
• • • 7.6.3 You cannot set the volume of high priority alarms if Alarm Volume is set to 0. You can set the Alarm Volume to 0 only when your monitor is connected to the CMS. If your monitor is not connected to the CMS, the lowest setting of Alarm Volume is 1. When your monitor is connected to the CMS and Alarm Volume is set to 0, Alarm Volume automatically changes to 2 if the CMS is disconnected.
Module ECG Resp Parameter Upper Limit Auto Limit Range Adult/ pediatric Neonate Adult/ pediatric Neonate HR/PR (bpm) HR × 0.8 or 40 (whichever is greater) (HR - 30) or 90 (whichever is greater) HR × 1.25 or 240 (whichever is smaller) (HR + 40) or 200 (whichever is smaller) Adult/pediatric: 35 to 240 RR (rpm) RR × 0.5 or 6 (whichever is greater) (RR - 10) or 30 (whichever is greater) (RR × 1.
Module Parameter Lower Limit Upper Limit Adult/ pediatric Neonate Adult/ pediatric Neonate IBP: CVP/ LAP/ RAP/ UVP/P1P4 (Venous pressure) IBP-M (mmHg) Mean × 0.75 Mean × 0.75 Mean × 1.25 Mean × 1.
2. 7.6.6 Select Apnea Delay to set the zero respiration rate delay time. Switching on or off V-Tach Latching When V-Tach Latching Lock is switched on, you can switch on or off V-Tach Latching. To do so, follow this procedure: 1. 2. 7.6.7 Access the Setup page in either of the following ways in either of the following ways: ◆ Select the Alarm Setup quick key → select the Setup tab. ◆ Select the Main Menu quick key → from the Alarm column select Setup. Switching on or off V-Tach Latching.
NOTE • 7.7.1.2 Prolonging alarm pause time does not affect the setting of alarm pause time. Switching Off All Alarms If Pause Time is set to Permanent (see section 25.3.3.1 Setting the Alarm Pause Time/Alarm Tone Pause Time), Pressing the Alarm Pause quick key permanently switches off all alarms. The alarm off state has the following features: ■ Physiological alarms are switched off. The alarm lamp does not flash and alarm sound is not issued.
7.8 Resetting Alarms Press the Alarm Reset quick key to acknowledge the ongoing alarms and reset the alarm system. When the alarm system is reset, the alarm reset symbol displays in the system status information area for alarm symbols. NOTE • 7.8.1 If a new alarm is triggered after the alarm system is reset, the alarm reset icon will disappear and the alarm light and alarm tone will be reactivated.
7.10 Nurse Call The monitor provides a nurse call connector to output a nurse call signal when a user-defined alarm occurs. To obtain a nurse call signal, use the nurse call cable to connect the hospital nurse call system with the monitor’s nurse call connector. Alarms are indicated on the nurse call device only when the following conditions are met: ■ The nurse call system is enabled. ■ A user-defined alarm occurs. ■ Alarms are not paused or reset. WARNING • 7.
7.12.2 Exiting the CPB Mode To exit the CPB mode, choose either of the following ways: 7.13 ■ Select the CPB Mode quick key. ■ Select the Main Menu quick key → from the Alarm column select Exit CPB Mode. Intubation Mode Intubation mode is available for Resp, CO2, and AG monitoring. When performing intubation during general anesthesia, you can put the monitor in the intubation mode in order to inactivate unnecessary alarms.
8 Monitoring ECG, Arrhythmia, ST and QT 8.1 ECG Introduction The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as waveforms and numerics. ECG monitoring provides 3-, 5-, 6-, and 12-lead ECG monitoring, ST-segment analysis, arrhythmia analysis, QT/QTc measurements, and optional 12-lead resting analysis via the Glasgow algorithm. The associated monitor incorporating ST analysis has the ST label.
(1) ECG lead label of the displayed waveform (2) ECG waveform gain (3) ECG filter mode (4) Notch filter status (5) Paced status: If Paced is set to Yes, is displayed. If Paced is set to No, is displayed. (6) HR/PR alarm message (7) Pace pulse marker: If Paced is set to Yes, pace pulse markers “|” are displayed corresponding to detected pacer for each beat. (1) (2) (4) (3) (1) Parameter label (2) HR measurement unit (3) HR alarm limits (4) HR value 8.4 Preparing for ECG Monitoring 8.4.
on muscles of the thorax, may lead to erroneous arrhythmia alarms due to excessive muscle movement. 8.4.3 Lead Wire Color Code The following table lists the color coding of leadwires for AHA standards: 8.4.
more information, see 8.4.4.3 Chest Electrode Placement. The Va and Vb lead positions are configurable. For more information, see 8.5.3.3 Changing Va and Vb Labels. 8.4.4.3 Chest Electrode Placement The chest electrode can be placed at the following positions: ■ ■ V1 placement: on the fourth intercostal space to the right of the sternum. V2 placement: on the fourth intercostal space to the left of the sternum. V6 V1 V5 ■ V3 placement: midway between the V2 and V4 electrode positions.
WARNING • • • • 8.4.5 To reduce the hazard of burns during use of electrosurgical units (ESU), the ECG electrodes should not be located between the surgical site and the ESU return electrode. Never entangle the ESU cable and the ECG cable together. When using ESU, never place ECG electrodes near the grounding plate of the ESU, as this can cause a lot of interference on the ECG signal.
8.4.7 Enabling Pacer Rejection The pace pulse rejection function is disabled by default. To enable this function, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG dialog. 2. Select the Pacer tab. 3. Switch on Pacer Reject. NOTE • • When pace pulses are detected, the pace pulse markers “|” are shown on the ECG waveforms. Pacer Rejection setting has no impact on the display of pace pulse markers “|”.
4. If more than three ECG waveforms are to be displayed, select the More Leads tab, and then select ECG to set leads of other ECG waveforms. For optimal ECG analysis, select leads with the following characteristics: ■ The QRS complex should be either completely above or below the baseline and it should not be biphasic. ■ The QRS complex should be tall and narrow. ■ The P waves and T waves should be less than 0.2mV. CAUTION • 8.5.3.
artifacts and interference from electrosurgical units. Under normal measurement conditions, selecting Surgery may suppress certain features or details of the QRS complexes. ◆ 8.5.3.6 ST: recommended for ST monitoring. Switching On or Off the Notch Filter The notch filter removes the line frequency interference. To switch on or off the notch filter, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG dialog. 2. Select the Setup tab. 3.
• If the QRS amplitude is low, the monitor might not be able to detect the beats and false asystole calls may occur. NOTE • 8.6 The minimum QRS detection threshold can only be adjusted when the ECG filter is set to Monitor. Monitoring Arrhythmia Arrhythmia monitoring is intended for adult and pediatric patients. 8.6.1 Arrhythmia Safety Information WARNING • • • Heart rate reading may be affected by cardiac arrhythmias.
8.6.2.2 Nonlethal Arrhythmia Events Arrhythmia message Description Vent Brady The number of consecutive PVCs is greater than or equal to V brady PVC limit and the ventricular rate is less than the V-Brady Rate limit. Extreme Tachy The heart rate is greater than the extreme tachycardia limit. Extreme Brady The heart rate is less than the extreme bradycardia limit. R on T R on T PVC is detected.
2. Click the numeric area where you want to display the arrhythmia information, and then select ECG → Arrhythmia. 8.6.4 Changing Arrhythmia Settings 8.6.4.1 Changing Arrhythmia Alarm Settings To set the arrhythmia alarm properties, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG dialog. 2. Select the Arrhythmia tab→ Alarm tab. 3. Set alarm properties as desired. NOTE • • 8.6.4.
8.6.4.4 Arrhythmia Threshold Range Pause Threshold 1.5 sec, 2.0 sec, 2.5 sec, 3.0 sec AF/Irr Rhy End Time 0 min, 1 min, 2 min, 3 min, 4 min, 5 min, 10 min, 15 min, 30 min Setting Thresholds for PVC-Related Alarms PVC-related alarms are detected on the basis of the current PVC rate and the number of consecutive PVCs. To set the required thresholds for PVC-related alarms, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG dialog. 2.
8.6.5.1 Arrhythmia Alarm Chains If multiple alarms overlap, announcing all of the detected alarm conditions would be confusing, and a more serious condition might be overlooked. So arrhythmia alarms are prioritized by alarm "chains".
8.6.5.3 Arrhythmia Alarm Refractory Period For the following eight alarms in medium priority chain, there is a 30-second refractory period. That is to say, if the same alarm is not presented within 30 seconds after the previous alarm disappears. 8.7 ■ Couplet ■ R on T ■ PVCs/min High ■ Multiform PVCs ■ PVC ■ Missed Beat ■ Pacer not Capture ■ Pacer not Pacing ST Segment Monitoring ST segment analysis is intended for adult, pediatric and neonatal patients.
The ST parameter display area is configured differently according to the ECG cable used: ■ When you are using the 3-lead ECG leadwires, a separate ST numeric area does not appear on the display. The ST deviation value displays in the ECG numeric area. ■ When you are using the 5-lead ECG leadwires, the ST numeric area displays 7 ST deviation values: ST-I, ST-II, ST-III, ST-aVR, ST-aVL, ST-aVF, ST-V.
(1) ST lead (2) Current ST deviation value (3) Baseline ST deviation value (4) 1 mV scale (5) Current ST segment (green) and baseline ST segment (white) 8.7.5 Entering the ST View In ST View mode a complete QRS segment for each ST lead is displayed. The color of the current ST segments and ST deviation values is consistent with the color of the ECG waveforms, normally green. The color of the baseline ST segments and ST deviation values is white. To enter the ST View, follow this procedure: 8.7.6 1.
The following figure shows the ST Graphic when ST Alarm Mode is set to Relative. The height of grey bar indicates the baseline ST deviation value and the green bar (cyan, yellow or red if an alarm occurs) indicates relative ST from that baseline. 8.7.8 Changing ST Settings 8.7.8.1 Setting ST Alarm Properties To set ST alarm properties, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG dialog. 2. Select the ST tab→ Alarm tab. 3.
8.7.8.3 Showing ISO Point, J Point, and ST Point Markers In the waveform area, the ISO point, J point, and ST point marker do not display on the ST segments by default. To display these markers, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG dialog. 2. Select the ST tab→ select the Setup tab. 3. Switch on Show Markers. 8.7.9 Adjusting ST Measurement Points 8.7.9.
■ 8.8 The ST point is positioned a fixed distance from the J point. Position the ST point relative to the J point at J+60/80ms, J+40ms, J+60ms or J+80ms. When J+60/80ms is selected, the ST point will be positioned 80 ms (heart rate 120 bpm or less) or 60 ms (heart rate more than 120 bpm) from the J point. QT/QTc Interval Monitoring The QT interval is the time between the beginning of the Q-wave and the end of the T-wave.
NOTE • QTc values are calculated based on the QT-HR, not the ECG HR. To view the QT-HR, open the QT View. For more information, see 8.8.4 Entering the QT View. The following picture shows the QT numeric area. The monitor screen may look slightly different: (3) (2) (4) (5) (1) (6) (1) QTc alarm limit (if QTc alarm is off, the alarm off symbol is displayed) (2) Parameter label (3) QTc value (4) ΔQTc value (the difference between the current and baseline QTc values) (5) QT value 8.8.
8.8.5 Saving the Current QTc as Baseline In order to quantify changes in the QTc value, you can set a QTc baseline. If no baseline has been set for this patient within the first five minutes after getting valid QT values, the monitor will automatically set a baseline. To set the current values as baseline, follow this procedure: 1. From the QT View, select Set Baseline. 2. From the pop-up dialog box, select OK. This baseline will then be used to calculate ΔQTc.
8.9.2 Initiating an ECG Relearning Manually If you suspect that false arrhythmia alarms are presented, you may need to manually initiate an ECG relearn. To do so, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG dialog. 2. Select Relearn. CAUTION • 8.10 Initiate ECG relearning only during periods of predominantly normal rhythm and when the ECG signal is relatively noise-free.
Problem Corrective Actions Intermittent Signal 1. Check that cables are properly connected. 2. Check that electrodes are not detached or dry. Perform skin preparation again as described in 8.4.1 Preparing the Patient Skin and apply fresh and moist electrodes. 3. Check that the patient cable or leadwires are not damaged. Change them if necessary. Excessive alarms: heart rate, lead fault 1. Check that electrodes are not dry. Perform skin preparation again and re-place the electrodes.
9 Resting 12-Lead ECG Analysis 9.1 Resting 12-Lead ECG Analysis Introduction The monitor can be configured with the Glasgow 12-lead resting ECG analysis algorithm.The monitor incorporating the Glasgow algorithm is labelled with the logo of Glasgow as shown in 8.1 ECG Introduction. The Glasgow algorithm is intended for adult, pediatric, and neonatal patients. 9.2 Entering the 12-Lead Screen To enter the 12-Lead screen, follow this procedure: 1.
9.4.2 Setting the Baseline Drift Removal Filter The baseline drift removal (BDR) filter suppresses most baseline drift interference and also is able to preserve the fidelity of the ST-segment level. BDR is switched on by default. To set the BDR, follow this procedure: 1. On the ECG 12-Lead screen, select the ECG numeric area or waveform area to enter the ECG dialog. 2. Select the Setup tab. 3. Switch on or off Baseline Drift Removal as desired. If BDR is switched off, the 0.
NOTE • • 9.4.6 The tachycardia threshold only applies to patients whose age exceeds 180 days. The bradycardia threshold only applies to patients whose age exceeds 2191 days (6 years). Setting the 12-Lead Interpretation Report To set the 12-lead interpretation report, follow this procedure: 9.5 1. On the ECG 12-Lead screen, select Setup to enter the 12-Lead Setup dialog. 2. Select the Report tab. 3. Set the format and items included in the 12-lead interpretation report.
10 Monitoring Impedance Respiration (Resp) 10.1 Resp Introduction Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Impedance respiration rate (RR) is calculated from the signal representing these impedance changes, and a respiration waveform is displayed on the patient monitor screen.
(1) Resp waveform gain (2) Resp lead label (4) Respiration rate (RR) (5) RR source (3) Alarm limits NOTE • If ESU-proof ECG cables are used, the Resp waveform area will display the message “Check Leads”. Replace the ECG cable if necessary. 10.4 Preparing for Impedance Resp Monitoring 10.4.1 Preparing the Patient Follow this procedure to prepare the patient: 1. Shave hair from skin at chosen sites. 2. Gently rub skin surface at sites to remove dead skin cells. 3.
CAUTION • • • • • Correct electrode placement can help to reduce interference from cardiac related impedance changes: avoid including the liver area and the ventricles of the heart between the respiratory electrodes. This is particularly important for neonates. Some patients with restricted movements breathe mainly abdominally. In these cases, you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory waveform.
10.5.4 Setting the Resp Waveform Size To set the Resp waveform size, follow this procedure: 10.5.5 1. Select the Resp numeric area or waveform area to enter the Resp dialog. 2. Select the Setup tab. 3. Set Gain. Setting the Resp Waveform Speed To set the Resp waveform speed, follow this procedure: 10.5.6 1. Select the Resp numeric area or waveform area to enter the Resp dialog. 2. Select the Setup tab. 3. Set Speed.
11 Monitoring Pulse Oxygen Saturation (SpO ) 11.1 SpO2 Introduction 2 Pulse Oxygen Saturation (SpO2) monitoring is a non-invasive technique used to measure the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the emitter side of the probe is partly absorbed when it passes through the monitored tissue. The amount of transmitted light is detected in the detector side of the probe.
CAUTION • • • • Change the application site or replace the sensor and/or patient cable when a persistent SpO2 Low Signal Quality message is displayed on the equipment. These messages may indicate that patient monitoring time is exhausted on the patient cable or sensor. Replace the cable or sensor when a “SpO2 Sensor Off”, “SpO2 No Sensor”, or “SpO2 Low Signal Quality” message is consistently displayed while monitoring consecutive patients after completing troubleshooting steps listed in this manual.
■ 11.4 ◆ Defibrillation (may cause inaccurate reading for a short amount of time) ◆ Excessive patient/sensor motion ◆ Electromagnetic field ◆ Arterial catheters and intra-aortic balloon Others ◆ Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor ◆ Cuff or arterial blood pressure measurement device on the same limb as the SpO2 sensor SpO2 Display (5) (4) (1) (2) (3) (1) Pleth waveform (Pleth/Plethb): visual indication of patient’s pulse.
• • Avoid placing the sensor on extremities with an arterial catheter, an NIBP cuff or an intravascular venous infusion line. For neonatal patients, make sure that all sensor connectors and adapter cable connectors are outside the incubator. The humid atmosphere inside can cause inaccurate measurements. 11.6 Changing the SpO2 Settings 11.6.1 Changing the SpO2 Alarm Settings To change the SpO2 alarm settings, follow this procedure: 1.
After approximately 11 seconds, a Sat-Second alarm would sound, because the limit of 50 SatSeconds would have been exceeded. %SpO2 Seconds Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Often, the patient SpO2 may fluctuate above and below an alarm limit, re-entering the non-alarm range several times.
CAUTION • When using the Maximum Sensitivity setting, performance of "Sensor Off" detection may be compromised. If the equipment and the sensor becomes detached from the patient, the potential for false readings may occur due to environmental noise such as light, and vibration. NOTE • 11.6.4 The settings of sensitivity in the SpO2 module and SpO2b module are linked.
11.7.2 Changing the QRS Volume If the Alarm Source is set to PR, the QRS tone is derived from PR measurements. To set the QRS volume, follow this procedure: 1. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. 2. Select the PR Setup tab. 3. Set QRS Volume. If the SpO2 value is valid, the monitor also adjusts the QRS tone (pitch tone) according to the SpO2 value. For information, see25.14.3 Setting the SpO2 Tone Mode. NOTE • 11.7.
11.9 Problem Solution Do not see SpO2 numeric area or waveform area on the main screen 1. Check that the SpO2 is set to display in the Screen Setup → → Tile Layout page. For more information, see 3.9.2 Displaying Parameter Numerics and Waveforms. 2. Check that the SpO2 parameter switch is enabled. If not, enable the SpO2 measurement.For more information, see 3.9.1 Switching On or Off a Parameter. 3. Check that the cable connections of the SpO2 sensor and the extension cable are tight.
12 Monitoring Temperature (Temp) 12.1 Temperature Introduction The monitor can continuously monitor the patient’s skin temperature and core temperature. Thermally sensitive resistors (thermistors) are used, and are based on the principle that electrical resistance of the thermistor changes as temperature changes. The resistance change of the thermistors is used to calculate the temperature.
12.5 Changing Temperature Settings 12.5.1 Setting the Temperature Alarm Properties To set the temperature alarm properties, follow this procedure: 12.5.2 1. Select the temperature numeric area to enter the Temp dialog. 2. Select the Alarm tab. 3. Enter the password if required. For more information, refer to 25.13.3 Selecting Password for User Authentication. 4. Set the alarm properties as desired. Selecting the Temperature Label Select the temperature label according to the measurement site.
Problem Solution Do not see Temp numeric area on the main screen 1. Check that if the Temp parameter switch is enabled. If not, enable the Temp measurement. For more information, see 3.9.1 Switching On or Off a Parameter. 2. Check that the connections of the temperature probe and the temperature cable are tight. Measurement fails/’--’ is displayed in the Temp numeric area 1. If using a disposable probe, check the connection between the probe and the temperature cable. 2.
13 Monitoring Noninvasive Blood Pressure (NIBP) 13.1 NIBP Introduction The monitor uses the oscillometric method for measuring Non-Invasive Blood Pressure (NIBP). NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. The oscillometric device uses a blood pressure cuff to sense these oscillations that appear as tiny pulsations in cuff pressure.
• • Never connect intra-arterial or intra-venous lines, or any other incompatible connectors to the NIBP hose. This can cause serious injury or death. NIBP diagnostic significance must be decided by the hospital’s clinician staff. CAUTION • • 13.3 Only use parts and accessories specified in this manual. Follow the instructions for use and adhere to all warnings and cautions. Accuracy of NIBP measurement depends on using a cuff of proper size.
(1) Systolic pressure alarm limits (2) NIBP unit: mmHg or kPa (3) The last NIBP measurement time (4) Time to the next measurement (for Auto mode and Sequence mode) (5) Measurement mode: for Auto NIBP, interval is displayed; for Sequence mode, the current phase and interval are displayed (6) Diastolic pressure (7) Diastolic pressure alarm limit (8) Mean pressure alarm limit (9) Mean pressure (displayed after measurement completed) or cuff pressure (displayed during the measurement) (10) Systolic pressu
d 4. Middle of the cuff should be at the level of the right atrium of the heart. If it is not, use the measurement correction formula to correct the measurement. For more information, see 13.8.7 Setting the NIBP Display Format. Connect the cuff to the air tubing. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing. CAUTION • • 13.7 Do not touch or apply external pressure against the cuff and air tubing during NIBP measurement.
13.8.2 Setting the Initial Cuff Inflation Pressure To set initial cuff inflation pressure, follow this procedure: 1. Select the NIBP numeric area to enter the NIBP dialog. 2. Select Initial Pressure, and then select the appropriate setting. NOTE • 13.8.3 For known hypertensive patients, you need to set initial cuff pressure to a higher value to reduce the measurement time. Setting the NIBP Interval For auto NIBP measurement, you need to set the interval between two NIBP measurements.
13.8.7 Setting the NIBP Display Format To set the NIBP display format, follow this procedure: 13.8.8 1. Select the NIBP numeric area to enter the NIBP menu. 2. Select the Setup tab. 3. Set Display Format. Setting the NIBP Alarm Limits Display Switch To set whether to display the alarm limits of diastolic NIBP and mean NIBP, follow this procedure: 13.8.9 1. Select the NIBP numeric area to enter the NIBP menu. 2. Select the Setup tab. 3. Switch on or off Display Alarm Limits.
Problem Solution Cannot see NIBP numeric area on the main screen 1. Check that the NIBP is set to display in the Screen Setup → Tile Layout page. For more information, see.3.9.2 Displaying Parameter Numerics and Waveforms 2. Check that if the NIBP parameter switch is enabled. If not, enable the NIBP measurement. For more information, see 3.9.1 Switching On or Off a Parameter.
14 Monitoring Invasive Blood Pressure (IBP) 14.1 IBP Introduction IBP monitoring is intended for adult, pediatric, and neonatal patients. PAWP monitoring is only intended for adult and pediatric patients. You can monitor up to 4 (using the built-in IBP module and the external IBP module together) invasive blood pressures. The following picture shows the external IBP module. (1) (2) (3) (3) (1) IBP menu hard key 14.
14.3 Preparing for IBP Monitoring 14.3.1 IBP Equipment to Patient Connection (1) (2) ｍ ｍ Ｈｇ (3) (4) (5) (5) (1) Pressure bag/Infusion pump (2) Monitor (3) IBP cable (4) IBP transducer (5) Three-way valve 14.3.2 Measuring an Invasive Blood Pressure To monitor IBP, follow this procedure: 1. Connect one end of the IBP cable to the IBP cable connector, and the other end to the IBP transducer. 2.
14.3.3 Zeroing the IBP transducer To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital policy. The IBP transducer should be zeroed in the following conditions: ■ The IBP transducer, adapter cable or module is reconnected. ■ The monitor restarts. ■ The readings are in doubt. ■ The monitor displays the prompt message Zero Required. To zero the transducer, follow this procedure: 1.
If the patient being monitored for ICP must be transported, check that the target monitor supports the Codman ICP transducer. For more information, see 14.4.1 Zeroing the Codman ICP transducer. If the target monitor does not support the Codman ICP transducer, do not use it for ICP monitoring. If the target monitor supports the Codman ICP transducer, follow this procedure to transport the patient: 1. Disconnect the ICP adapter cable from the measurement module, or remove the module from the monitor. 2.
Selecting the overlapped IBP waveforms on the main screen opens the Overlapping Waveform Setup dialog, where you can make the following settings: ■ Scale ◆ Set Left Scale for the arterial pressure. ◆ Set Right Scale for the venous pressure. ◆ Set CVP Scale individually if the CVP waveform is combined and CVP unit is different from IBP unit. ◆ Set ICP Scale individually if the ICP waveform is combined and ICP unit is different from IBP unit.
NOTE • 14.6.3 The same label cannot be selected for different pressures. When two pressures are detected having the same label, the monitor automatically changes one pressure label to a currently unused one. Setting the Pressure Type for Display For the non-specific pressure (P1, P2, P3 or P4), the displayed pressure type is configurable. To set the displayed pressure type, follow this procedure: 14.6.4 1.
14.6.8 Setting the Use PA-D as PAWP Switch The PA-D value can be configured to replace the PAWP value for hemodynamic calculation. To do so, follow this procedure: 1. Select the PA numeric area or waveform area to enter the PA dialog. 2. Select the Setup tab. 3. Switch on or off Use PA-D as PAWP. For more information on hemodynamic calculation, see 20.4 Hemodynamic Calculations. 14.6.9 Enabling PPV Measurement PPV indicates pulse pressure variation.
14.7.1 PAWP Equipment to Patient Connection (1) (2) (3) (4) (6) (7) (8) (5) 14.7.2 (1) MPM/IBP module (2) Flush bag (3) IBP transducer (4) Three-way valve (5) PA distal port (6) Balloon inflation syringe (7) Thermodilution catheter (8) Balloon Preparing to Measure PAWP To prepare to monitor PAWP, follow this procedure: 14.7.3 1. Connect the IBP transducer, the IBP cable and the module. For more information, see 14.3.2 Measuring an Invasive Blood Pressure. 2.
2. Wedge the flotation catheter into the pulmonary artery by observing the PA waveform changes on the screen, referring to the following figure. 3. Select Start. 4. Inflate the balloon and pay attention to PA waveform changes on the screen when the prompt message Ready For Balloon Deflation appears. 5. Deflate the balloon when the prompt message Ready For Balloon Deflation appears.
WARNING • • • Prolonged inflation can cause pulmonary hemorrhage, infarction or both. Inflate the balloon for the minimum time necessary to get an accurate measurement. If the PAWP is greater than the PA (systolic), deflate the balloon and report the incident in accordance with hospital policy. Because the pulmonary artery could be accidentally ruptured, and the PAWP value derived will not reflect the patient’s hemodynamic state, but will merely reflect the pressure in the catheter or balloon.
(1) External IBP module (2) Camino ICP cable (3) ICP adapter (4) ICP connector (5) Camino cable (6) Camino monitor WARNING • • 14.9 Refer to the Camino Operator’s Manual to adjust settings and connect the monitor with the patient. ICP alarm settings on the Mindray patient monitor are independent of the Camino monitor alarm settings, and thus may be different. Please pay special attention to the alarms on the Camino monitor. IBP Troubleshooting This section lists the problems that might occur.
15 Monitoring Cardiac Output (C.O.) 15.1 C.O. Introduction The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart (atria) thermodilution method. A cold solution of known volume and temperature is injected into the right atrium through the proximal port of a pulmonary artery (PA) catheter.
15.3 C.O. Measurement Limitations The following factors may influence the accuracy of C.O. measurement: ■ temperature of injectate solution ■ volume of injectate solution ■ baseline of patient’s blood temperature ■ patient’s inspiratory/expiratory cycle ■ placement of catheter with relation to proximity of lung field ■ the catheter itself ■ patient’s heart rate and hemodynamic status ■ any solution infused with intravenous injection during the C.O. measurement To obtain accurate C.O.
15.5 C.O. Equipment to Patient Connection (1) Monitor (2) 12-pin C.O. cable (Model: CO7702) (3) TI cable connector (4) In-line probe (5) Injectate solution (6) Injectate syringe (7) Three-way valve (8) Proximal injectate port (9) Balloon inflation valve (10) Thermistor connector (11) PA distal port (12) Thermodilution catheter (13) Thermistor 15.6 Performing C.O. Measurement 15.6.1 Preparing for C.O. Measurement 1. Connect the C.O. cable to the C.O.
To change the computation constant, select Comp Const and then input the correct value. When a new catheter is used, the computation constant should be adjusted in accordance with the manufacturer’s instructions for use. 15.6.3 ◆ Switch on or off Auto TI. If Auto TI is switched on, the system automatically detects the injectate temperature, and TI setting is disabled. If Auto TI is switched off, you need to input the injectate temperature at TI. ◆ Switch on or off Auto Start.
The button area also provides you with the following functions: ■ Select Stop to stop the current measurement. Select Setup to enter the C.O. dialog. ■ Select Hemo Calcs to enter the Calculations dialog. NOTE • • • Starting a measurement without blood temperature being stable may cause measurement failure. The TB alarms are inactivated during a C.O. measurement, and will be reactivated automatically after the completion of C.O. measurement.
15 - 6 Problem Solution C.O. measurement fails 1. Inject more volume, or inject colder solution. Make sure that the injectate temperature is at least 10°C colder than the patient blood temperature. 2. Finish injection within four to five seconds. 3. Check the connection of C.O. cable, thermodilution catheter and TI sensor.
16 Monitoring Carbon Dioxide (CO2) 16.1 CO2 Introduction CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2 in the patient’s airway by measuring the absorption of infrared (IR) light of specific wavelengths. CO2 has its own absorption characteristic and the amount of light passing the gas probe depends on the concentration of the measured CO2.
To measure CO2 using the AG module, see 17 Monitoring Anesthetic Gas (AG). 16.3 CO2 Safety Information WARNING • Route all tubing away from the patient’s throat to avoid strangulation. CAUTION • • • • Shaking the CO2 module during O2 measurement may lead to a distorted O2 waveform or inaccurate O2 measurement Remove the airway sample line from the patient’s airway while nebulized medications are being delivered. Measuring CO2 during nebulization may lead to inaccurate CO2 readings.
If the sidestream CO2 module is configured with the oxygen sensor, O2 waveform and parameters can be displayed in an O2 numeric and waveform area as follows: (3) (2) (1) (1) O2 waveform (2) FiO2 measurement (3) EtO2 measurement 16.6 Measuring CO2 Using the Sidestream/Microstream CO2 Module 16.6.1 Preparing to Measure CO2 Using the Sidestream CO2 Module To prepare the CO2 module for measurement, follow this procedure: 1.
◆ 4. For non-intubated patients, place the nasal cannula onto the patient. Connect the gas outlet to the scavenging system using an exhaust tube. After the CO2 module is connected, it enters measure mode by default and the monitor displays CO2 Starting. CO2 can be measured after the start-up sequence is complete. WARNING • • Do not use the adult or pediatric watertrap with a neonate patient. Otherwise, patient injury could result.
16.6.2 Preparing to Measure CO2 Using the Microstream CO2 Module To prepare the CO2 module for measurement, follow this procedure: 1. Connect one end of the sample line to the microstream CO2 module. (1) (2) (1) Sample line connector 2. 3. (2) Sample line Connect the other end of the sample line to the patient. ◆ For intubated patient requiring an airway adapter, install the airway adapter between the patient circuit and the ventilator Y-piece.
16.7 Measuring CO2 Using Mainstream CO2 Module 16.7.1 Preparing to Measure CO2 Using Mainstream CO2 Module To prepare the CO2 module for measurement, follow this procedure: 1. Connect the airway adapter to the sensor head. (2) (1) (3) (1) Sensor (2) Connect to module (3) Airway adapter 2. Attach the sensor connector to the CO2 connector on the mainstream CO2 module. 3. Zero the sensor after the warm-up is finished. For details, see 16.7.2 Zeroing the Mainstream CO2 sensor. 4.
16.7.2 Zeroing the Mainstream CO2 sensor For mainstream CO2 modules, the sensor should be zeroed in the following conditions: ■ Before each measurement. ■ A new adapter is used. ■ Reconnect the sensor to the module. ■ The message CO2 Zero Required displays. In this case, check the airway adapter for any blockage, e.g. mucus, etc. If a blockage is detected, clear or replace the adapter. To zero the sensor, follow this procedure: 1. Connect the sensor to the module. 2.
When you select Auto, the system automatically selects the RR source according to the priority. The priority of RR source is first CO2, and then ECG. When the current RR source does not have valid measurement, the system automatically switches the RR Source to Auto. 16.8.4 Entering the Standby Mode Set the CO2 module to one of the following modes according to the module status: ■ Select Measure mode when using the CO2 module for monitoring.
◆ Switch off for ATPD. 16.9 Changing Settings for Sidestream and Microstream CO2 Module 16.9.1 Setting the Auto Standby The monitor enters standby mode automatically after the configured period of time if no breath is detected since the last detected breath. To set the auto standby, follow this procedure: 16.9.2 1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select the Setup tab. 3. Set Auto Standby.
16.10.2 Setting the O2 Waveform To set the O2 waveform, follow this procedure: 16.11 1. Select the CO2 numeric area or waveform area to enter the CO2 dialog. 2. Select the Setup tab. 3. Set Speed and O2 Scale of the O2 waveform. Setting the Gas Compensation The presence of interfering gas affects the CO2 measurement. To get the best possible measurement result, it is recommended to set the gas compensation.
This indicates that the module does not leak. If the alarm message disappears, or the flow rate is equal to 10ml/min or greater, it indicates that the module leaks. Perform the leakage test again. If the problem remains, contact your service personnel for help. 16.14 CO2 Calibration For sidestream and microstream CO2 modules, a calibration is needed every year or when the measured values have a great deviation. To calibrate the CO2 module, contact your service personnel. CAUTION • 16.
17 Monitoring Anesthetic Gas (AG) 17.1 AG Introduction The anesthetic gas (AG) module measures the patient’s anesthetic and respiratory gases by connecting to the airway of intubated patients or collecting the gases with specified accessories. It also incorporates the features of the O2 module. The AG module determines the concentration of certain gases using the infrared (IR) light absorption measurement. The gases that can be measured by the AG module absorbing IR light.
17.2 AG Safety Information WARNING • • • To avoid explosion hazard, do not use flammable anesthetic agent such as ether and cyclopropane for this equipment. Using high-frequency electrosurgical units may increase the risk of skin burn. In this case, do not use antistatic or conductive respiratory tubing. Route all tubing away from the patient’s throat to avoid strangulation. CAUTION • • Perform the measurement in a well-ventilated environment.
If only one anesthetic agent is used, the AA waveform area displays the waveform of this anesthetic agent. If several anesthetic agents are used, the AA waveform area displays the waveform of the primary anesthetic agent. 17.5 AG Equipment to Patient Connection (4) ( ) (5) 17.
• • The watertrap collects water drops condensed in the sample line and therefore prevents them from entering the module. To avoid blocking the airway, empty the watertrap container whenever half full. The watertrap has a filter preventing bacterium, water and secretions from entering the module. After long-term use, dust or other substances may compromise the performance of the filter or even block the airway. In this case, replace the watertrap. Replacing the watertrap once a month is recommended.
17.8 Changing AG Settings 17.8.1 Changing AG Alarm Settings To change the AG alarm settings, follow this procedure: 17.8.2 1. Select the AG numeric area or waveform area to enter the Gas dialog. 2. Select the desired gas tab. 3. Select the Alarm tab. 4. Enter the password if required. For more information, refer to 25.13.3 Selecting Password for User Authentication. 5. Set alarm properties as desired.
4. 17.8.6 Set the speed and scale of gas waveforms. For CO2, set Waveform Type. Setting the RR Source To set the RR (respiration rate) source, follow this procedure: 1. Select the AG numeric area or waveform area to enter the Gas dialog. 2. Select the desired gas tab. 3. Select the Setup tab. 4. Set RR Source. When the current RR source does not have valid measurement, the system will automatically switch RR Source to Auto. 17.8.
This indicates that the module does not leak. If the alarm message disappears, or the flow rate is equal to 10ml/min or greater, it indicates that the module leaks. Perform the leakage test again. If the problem remains, contact your service personnel for help. 17.11 Calibrating the AG Module Calibrate the AG module every year or when the measured value is outside the specification. To calibrate the AG module, contact the service personnel. CAUTION • 17.
18 Review 18.1 Review Overview Trends are patient data collected over time and displayed in graphic, tabular, or other forms to give you a picture of how the patient's condition is developing. You can review the trend data in the Review dialog, minitrends screen, or OxyCRG screen. The Review dialog also enables access to review the events, 12-lead ECG analysis results and waveforms, full disclosure waveforms, and so on. 18.
(4) Time line: indicates the entire time length. : indicates the time length of trend data. ■ ■ ■ 18.2.3 : indicates the time length of no trend data. can be moved within this time length. cannot be moved within this time length. Different color blocks along the time line indicate events of different types. See the color definition for the event type indicator. (5) Event area: displays the event of the cursor time. Selecting the event access the event list.
Events are displayed in a chronological order. The most recent event is displayed at the top. The number of asterisk symbols before an event indicates alarm priority as follows: 18.2.5 ■ ***: high priority alarm ■ **: medium priority alarm ■ *: low priority alarm Tabular Trends Review Page The tabular trends review page displays trend data in a tabular form. 18.2.5.1 Entering the Tabular Trends Review Page Choose one of the following methods to enter the tabular trends review page: 18.2.5.
1. Enter the tabular trends review page. 2. Select Interval. ◆ 5 sec or 30 sec: select to view up to 4 hours of tabular trends at an interval of 5 seconds or 30 seconds. ◆ 1 min, 5 min, 10 min, 15 min, 30 min, 1 hr, 2 hrs, or 3 hrs: select to view up to 120 hours of tabular trends at selected interval. ◆ Select parameters, such as NIBP, or C.O., to view the tabular trends when these parameter measurements are acquired. NOTE • 18.2.5.
18.2.6.3 Editing the Graphic Trend Group 1. Enter the graphic trends review page. 2. Select Group Setup. For more information, see 18.2.5.3 Editing the Tabular Trend Group for detail on how to edit the group. 18.2.6.4 Changing the Resolution of Trend Data To change the length of trend data displayed on the current screen, follow this procedure: 18.2.6.5 1. Enter the graphic trends review page. 2. Select Zoom. ◆ 8 min: the screen displays eight minutes of trend data.
■ Red: high priority alarm event ■ Yellow: medium priority alarm event ■ Cyan: low priority alarm event ■ Green: manual event ■ White: operation-related event, such as accepting a C.O. average. The number of currently selected events and the total number of events are displayed at the top right corner of the event list. For example, 2/4 indicates that the selected event is the second event in the filtered events and the total number of filtered events is 4.
3. 4. 18.2.7.6 Select the desired options. ◆ Print All Event List: print the entire event list. ◆ Print List of Selected Events: print the list of selected events. ◆ Print Detail of Selected Events: print the details of selected events. ◆ Print Displayed Event Detail: print the waveforms and parameters of the currently displayed event. Select Print. Recording Event Details To print events details via a recorder, follow this procedure: 18.2.8 1. Enter the events review page. 2.
18.2.8.4 3. Select Duration to set the length of displayed waveforms. 4. Select the parameter label beside the waveforms to set scale for each parameter. Viewing Details of Compressed Waveforms To view the full waveforms and numeric values, follow this procedure: 1. Enter the full disclosure review page. 2. Select Detail. You can perform the following operations on the this page: 18.2.8.5 ■ Switch on Beat Anno. For more information, see 18.2.7.4 Viewing Event Details.
18.2.10.1 Entering the OxyCRG Review Page Choose one of the following methods to enter the OxyCRG review page: ■ From the OxyCRG screen, select the ABD events list area. ■ Select the Review quick key → select the OxyCRG tab. ■ Select the Main Menu quick key → from the Review column select OxyCRG. 18.2.10.
18.2.11 12-Lead ECG Review Page When 12-lead ECG analysis is performed, you can review the most recent 20 events of 12-lead analysis. For more information, see 9 Resting 12-Lead ECG Analysis. 18.2.11.1 Entering the 12-Lead Review Page Choose one of the following methods to enter the 12-lead ECG review page: ■ Upon completion of 12-lead ECG analysis, select Review from the 12-Lead Interpretation page. For more information, see 9 Resting 12-Lead ECG Analysis.
18.2.12.2 Setting the ST Reference You can set the currently displayed ST as reference. To do so, follow this procedure: 1. Enter the ST review page. 2. Select Set Reference. NOTE • The ST baseline is used as ST reference by default. 18.2.12.3 Displaying/Hiding the ST Reference To display or hide ST reference, follow this procedure: 1. Enter the ST review page. 2. Select Display Reference or Hide Reference. 18.2.12.4 Displaying/Hiding Markers To display or hide markers, follow this procedure: 1.
19 Clinical Assistive Applications (CAA) The Clinical Assistive Applications (CAA) function integrates some commonly used clinical guidelines and tools into the monitor. It puts the currently monitoring parameter measurements together and provides comprehensive analysis results. CAA can improve the clinician’s working efficiency. However, it is not directly used for diagnosis and cannot not replace the clinician’s judgement. 19.
19.1.1 Displaying the EWS Numerics Area To display the EWS numerics area, follow this procedure: 1. 2. Access Tile Layout in either of the following ways: ◆ Select the Screen Setup quick key → select the Tile Layout tab. ◆ Select the Main Menu quick key → from the Display column select Tile Layout. Select the parameter area where you want to display the EWS score, and then from the popup list select EWS. (8) (7) (1) (6) (2) (3) (4) 19.1.2 (5) (1) EWS protocol label (2) Total score.
(10) (9) (8) (7) (1) (6) (2) (5) (3) (4) 19.1.3 (1) Total score. The color of the circle indicates the level of risk. (2) Risk level indicator. The level of risk increases from top down. The current level is enclosed by a white frame. (3) Parameter area: display the subscore and parameter value of each parameter. The keyboard symbol indicates that the parameter value is manually entered.
CAUTION • The decision to use Scale 2 of the SpO2 Scale should be made by a competent clinical decision maker and should be recorded in the patient’s clinical notes. NOTE • • • Before calculating the score, select Reset to clear the previous score. The keyboard symbol at the right of the parameter value indicates that the value is manually entered. You can get the score only when all required parameters have been measured or entered. 19.1.4 Changing EWS Settings 19.1.4.
19.1.4.5 19.1.4.6 Setting Auto Scoring Interval 1. From the EWS page select Setup. 2. Set Interval: ◆ By Score: the monitor automatically starts scoring as per the interval selected for corresponding total score. ◆ 5 min - 24 h: If Auto Scoring is set to Interval, the monitor automatically starts scoring as per the selected interval. If Auto Scoring is not set to Interval, the countdown timer of manual scoring is selected. Managing Operator ID To manage the Operator ID, follow this procedure: 1.
(1) GCS label (2) Total score and level of consciousness. The color of the circle indicates the level of risk. (3) Scoring time (4) Scoring countdown: time to the next scoring (5) Scoring interval (6) Subscores ◆ E: eye opening ◆ V: verbal response ◆ M: motor response 19.2.2 Accessing the GCS Dialog Enter the GCS dialog in any of the following ways: ■ Select the GCS parameter area ■ Select the GCS quick key. ■ Select the Main Menu quick key → from the CAA column select GCS.
NOTE • 19.2.4 The GCS score range is adjustable. Refer to 25.4.2 Setting GCS Threshold for Each Consciousness Level for the method of changing the high limit and low limit of each consciousness level. Setting GCS Scoring Interval From the GCS dialog, select Interval to set GCS scoring interval. When the scoring interval is reached and you do not perform another scoring, the score will be invalidated and displayed as outline fonts. 19.2.
19.3.3 Reviewing ECG Summary From the ECG 24h Summary dialog, you can review corresponding trends and events. 19 - 8 ■ Select the Heart Rate area to review HR graphic trends. ■ Select the Max ST/Min ST area to review the current ST reference and ST graphic trends. ■ Select the Pace area to review historic pace events. ■ Select the QT area to review QT/QTc graphic trends. ■ Select the Arrhythmia area to review arrhythmia statistics. For more information, refer to 18.2.
20 Calculation 20.1 Calculation Overview The monitor provides calculation functions. The calculated values, which are not directly measured, are computed based on the values you provide. The calculation function is independent of other monitoring functions and can therefore be used for patients being monitored by other monitors. Any operation in a calculation dialog does not affect the patient monitored by the current monitor. You can perform the following calculations: 20.
20.3.2 Checking the Titration Table The titration table shows information on the currently used drugs. Use the titration table to see what dose of a drug your patient will receive at different infusion rates. To access the titration table, follow this procedure: 1. Access drug calculator by either of the following ways: ◆ Select the Calculations quick key. ◆ Select the Main Menu quick key → from the Calculations column select Drug. 2. Select the Titration Table tab. 3.
20.4 Hemodynamic Calculations The monitor provides the hemodynamic calculation function and can save the results of up to 10 calculations, which are displayed in groups. 20.4.1 Performing Hemodynamic Calculations To perform hemodynamic calculation, follow this procedure: 1. Access hemodynamic calculation by either of the following ways: ◆ Select the Calculations quick key → Hemodynamics tab. ◆ Select the Main Menu quick key → from the Calculations column select Hemodynamics. 2.
Calculated Parameters Label Unit Formula pulmonary vascular resistance PVR DS/cm5 P VR (DS/cm5) = 79.96 × [PAMAP (mmHg) - PAWP (mmHg)]/C.O. (L/min) pulmonary vascular resistance index PVRI DS•m2/cm5 PVRI (DS•m2/cm5) = PVR (DS/cm5)× BSA (m2) left cardiac work LCW kg•m LCW (kg•m) = 0.0136 × APMAP (mmHg) × C.O. (L/ min) left cardiac work index LCWI kg•m/m2 LCWI (kg•m/m2) = LCW (kg•m)/BSA (m2) left ventricular stroke work LVSW g•m LVSW (g•m) = 0.
20.5.2 20.5.3 Input Parameters for Oxygenation Calculations Input Parameter Label Unit cardiac output C.O.
20.6 Ventilation Calculations The monitor provides the ventilation calculation function and can save the results of up to 10 calculations, which are displayed in groups. 20.6.1 Performing Ventilation Calculations To perform ventilation calculations, follow this procedure: 1. Access ventilation calculation by either of the following ways: ◆ Select the Calculations quick key → Ventilation tab. ◆ Select the Main Menu quick key → from the Calculations column select Ventilation. 2.
20.7 Calculated Parameters Label Unit Formula volume of physiological dead space Vd ml Vd (ml) = TV (ml) × [1 - PeCO (mmHg)/PaCO (mmHg)] 2 2 physiologic dead space in percent of tidal volume Vd/Vt % Vd/Vt (%) = 100 × Vd (ml)/TV (ml) alveolar volume VA L/min VA (L/min) =[TV (ml) - Vd (ml)] × RR (rpm)/1000 Renal Calculations The monitor provides the renal calculation function and can save the results of up to 10 calculations, which are displayed in groups. 20.7.
20.7.
21 Recording 21.1 Recorder The thermal recorder records patient information, measurement data, and up to three waveforms. The monitor is configured with a built-in recorder. (1) (2) (3) (5) (4) 21.2 (1) Start/Stop key: press to start a recording or stop the current recording. (2) Module status indicator ◆ On: when the recorder works correctly. ◆ Off: when the monitor is switched off. ◆ Flashes: if an error occurred to the recorder.
21.3 Stopping Recordings Recordings can be stopped manually or automatically. 21.3.1 Stopping Recordings Manually To manually stop a recording, press the 21.3.2 hardkey while the recorder is creating a strip. Stopping Recordings Automatically Recordings stop automatically in the following conditions: 21.4 ■ The recording is completed. ■ The recorder runs out of paper. ■ The recorder has an alarm condition. ■ The recorder module is removed from the monitor. ■ The monitor is turned off.
21.7 Loading Paper To load paper, follow this procedure: 1. Use the latch at the upper right of the recorder door to pull the door open. 2. Insert a new roll into the compartment as shown below. Feed the paper through and pull some paper out from the top of the roller. 3. Close the recorder door. CAUTION • • • 21.8 Use only specified thermal paper. Otherwise, it may cause damage to the recorder’s printhead, the recorder may be unable to print, or poor print quality may result.
22 Printing 22.1 Supported Printer The monitor can output patient reports via a connected network printer. The monitor supports the following printers: ■ HP LaserJet Pro M202dw ■ HP LaserJet Enterprise M605 ■ HP LaserJet P4015n ■ HP LaserJet Pro 400 M401n ■ HP LaserJet 600 M602 ■ HP LaserJet Enterprise M608 NOTE • For more details about the printer, refer to the document accompanying the printer. With product upgrades, the monitor may support additional printers without prior notice.
22.2.3 Configuring End Case Reports To configure end case reports, follow this procedure: 22.2.4 1. Select the Main Menu quick key → from the Report column select End Case Report. 2. From the Report Setup page, set the following end case reports: ◆ Select the Tabular Trends Report, Graphic Trends Report, Realtime Report, and ECG Report tab, and set these end case report by referring to section 22.7 Viewing Printer Status. ◆ Select the Event Report tab, and select the event that needs to be printed.
22.4 Automatically Printing Reports When a parameter alarm switch is set to on and an alarm is triggered for this parameter, you can set the monitor to automatically print a Print on Alarm Report. To do so, follow this procedure: 1. 2. 22.5 Access alarm related tabs such as the Alarm tab for a parameter in one of the following ways: ◆ Select the Alarm Setup quick key at the bottom of the screen. ◆ Select the parameter or waveform area of the desired parameter → select the Alarm tab.
Menu item Function Description Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 Select the lead that will be used as Rhythm Lead 1, 2, or 3. I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Note: This setting is only relevant when 6×2+1,3×4+1, or 3×4+3 is selected for 12-Lead Format. Format sequence Select the recording method of ECG report generated by auto measurement Sequential: 12-lead ECG data are recorded sequentially and displayed in 3 lines and 4 columns with 2.
Menu Item Function Description Interval Select the resolution of the tabular trends printed on a report. NIBP, EWS, GCS, C.O.: at an interval of acquiring the values of selected parameter. Auto: using the Interval setting of the Tabular Trends review page. 5 sec to 3 hrs: the tabular trends will be printed at the interval of 5 sec to 3 hrs. Report Format Select the printing principle.
22.9 List of Reports The printer can output the following reports: ■ 22 - 6 Realtime reports ◆ Realtime Report ◆ Freeze Report ◆ ECG Report (5-lead, 6-lead, 12-lead) ◆ 12-Lead Interpretation Report (realtime) ◆ Print on Alarm Report ◆ Alarm Limits Report ◆ Titration Table Report ◆ Hemodynamic Calculation Report ◆ Oxygenation Calculation Report ◆ Ventilation Calculation Report ◆ Renal Calculation Report ◆ ST Report (Realtime) ◆ QT Report (Realtime) ◆ OxyCRG Report ◆ C.O.
23 Using the On-Screen Timers The monitor has a Timer function to notify you when a preset time period is expired or how much time has elapsed. You can simultaneously display up to four timers. 23.1 Displaying Timers To display a timer, follow this procedure: 1. 2. 23.2 Access Tile Layout in either of the following ways: ◆ Select the Screen Setup quick key → select the Tile Layout tab. ◆ Select the Main Menu quick key → from the Display column select Tile Layout.
24 Managing Configurations 24.1 Configuration Introduction When performing continuous monitoring on a patient, the clinical professional often needs to adjust the monitor’s settings according to the patient’s condition. The collection of all these settings is called a configuration. The system configuration items can be classified as: parameter configuration items, conventional configuration items, and user maintenance items.
24.4 Setting Default Configuration The monitor will load the pre-set default configuration in the following cases: ■ A patient is admitted. ■ A patient is discharged. ■ Patient category is changed. To set the default configuration, follow this procedure: 24.5 1. Select the Main Menu quick key → from the Configuration column select Manage → input the required password → Select . 2. Select Select Default Config. 3. Select Load the Latest Config or Load Specified Config.
24.7 Transferring a Configuration When installing several monitors with identical user configurations, it is not necessary to set each unit separately. Use a USB drive to transfer the configuration from monitor to monitor. 24.7.1 Exporting a Configuration To export the current monitor’s configuration, follow this procedure: 24.7.2 1. Connect the USB drive to the monitor’s USB port. 2.
24.9 Modifying Configuration Password To modify the configuration password, follow this procedure: 24 - 4 1. Select the Main Menu quick key → from the Configuration column select Manage → input the required password → Select . 2. Select Modify Password. 3. Respectively input the old password and new password. 4. Select OK.
25 Password-protected User Settings This chapter describes the password-protected functions accessed in the Maintenance dialog. 25.1 Setting the Device Location 25.1.1 Setting Monitor Information To set monitor information, follow this procedure: 25.1.2 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2. Select the Device Location tab. 3. Input monitor name, facility name and department name.
25.2.2 Auto Discharging a Patient after Monitor Power Off You can let the monitor automatically discharge after the monitor has been switched off for a period of time. To set the time period of discharging a patient, follow this procedure: 25.2.3 1. Select the Main Menu quick key → from the System column select Maintenance → input the required . password → select 2. Select the Patient Management tab→ select the Discharge tab. 3. Select a time for Auto Discharge When Power Off.
◆ Prompt on patient auto deleted: an alarm is issued when the monitor automatically deletes earlier discharged patients. ◆ Alarm on storage is nearly full: selects whether an alarm is issued when the monitor memory is very low and the priority of this alarm. 25.3 Changing the Alarm Settings 25.3.1 Setting Alarm Tone Properties 25.3.1.1 Setting the Minimum Alarm Volume To set the minimum alarm volume, follow this procedure: 1.
◆ 4. Off: if an alarm is not reset within the designated delay time after the alarm occurs, the volume of the alarm tone does not change. Select Increase Volume Delay to set the delay time of alarm volume escalation. NOTE • The alarm volume escalation function is not applied to the latched alarms. 25.3.2 Setting Alarm Pausing and Resetting Properties 25.3.3 Defining the Pause Function You can either pause alarms or pause alarm tones. This depends on the pause setting.
25.3.3.4 Setting Alarm Light Status on Alarm Reset When the alarm system is reset, the monitor presents the alarm light by default , but you can switch off the alarm light. To change the alarm light setting, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select 25.3.3.5 . 2. Select the Alarm tab → Pause/Reset tab. 3. Set Alarm Light.
25.3.5 Changing Remote Alarm Settings 25.3.5.1 Resetting Alarms for Remote Devices You can reset the alarms occurring on the remote devices that are viewed on the Remote View screen of the monitor. To enable this function, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2. Select the Alarm tab → Remote View tab. 3. Switch on Reset Remote Bed Alarms.
25.3.5.5 Setting the Tone Pattern for Alarms from Remote Devices The monitor provides the same alarm tone pattern for the remote device alarms as those for your monitor alarms. For more information on alarm tone pattern, see 7.3.3 Alarm Indicators. To set the alarm tone pattern for the remote device alarms, follow this procedure: 25.3.5.6 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2.
25.3.7 Changing Alarm Priority Settings 25.3.7.1 Setting the Priority of the ECG Lead Off Alarm To set the priority of the ECG lead off alarm, follow this procedure: 25.3.7.2 1. Select the Main Menu quick key → from the System column select Maintenance → input the required . password → select 2. Select the Alarm tab→ select the Other tab. 3. Set the priority of ECG Lead Off.
3. Set SpO2 Desat Alarm Off. ◆ ◆ Disable: the SpO2 Desat alarm is always on. You cannot switch it off. Enable: you can switch off the SpO2 Desat alarm. For more information, see 11.6.1 Changing the SpO2 Alarm Settings. WARNING • 25.3.7.7 If a clinician switches off the SpO2 Desat alarm, the monitor will not alarm when the patient’s SpO2 is extremely low. This may result in a hazard to the patient.
25.3.9 Changing Other Alarm Settings 25.3.9.1 Setting the Lethal Arrhythmia Alarms Switch To allow a clinician to disable the lethal arrhythmia alarms, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required . password → select 2. Select the Alarm tab→ select the Other tab. 3. From the Other block, set Lethal Arrh Alarms Off as follows. ◆ Lethal Arrh Alarms Off is set to Disable by default.
• • The arrhythmia alarm timeout period is only applied to the medium priority chains and atrial fibrillation chain. For the alarms in the high priority chain, alarm tone and alarm light are presented as soon as the alarm condition is detected. Refer to 8.6.5.1 Arrhythmia Alarm Chains for more information on the arrhythmia alarm chain. Alarm indication rules for alarms in the atrial fibrillation chain are the same with those for the medium priority chains. 25.4 Changing CAA Settings 25.4.
25.4.3 Defining the Hours of Nighttime for the ECG 24h Summary To define the nighttime for heart rate statistics, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2. Select the CAA tab → ECG 24h Summary tab. 3. Select From and To to define the beginning and end of Nighttime. 25.5 Changing Module Settings 25.5.1 Selecting the ECG Standard Select the ECG standard according to the leadwires you are using.
25.5.5 1. Select the Main Menu quick key → from the System column select Maintenance → input the required . password → select 2. Select the Module tab → ECG tab. 3. From the bottom left corner of the dialog select Calibrate. Setting Parameter Measurement Timeout NIBP measurements become outline fonts after a preset time. This feature prevents older values being misinterpreted as current measurements. To adjust the timeout period for PAWP, C.O., and NIBP, follow this procedure: 25.5.6 1.
◆ Select Paper Size. ◆ Select Resolution. After finishing configurations, you can select the Print Test Page button to verify that the printer works properly. 25.7.2 Setting Patient Information on General (Non-12-lead) Reports To set the patient information you want to display on general reports, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select 25.7.3 . 2. Select the Print tab. 3.
3. 25.7.7 Enable or disable Arrhy Settings (Recorder). Setting Parameter Unit To set parameter unit, follow this procedure: 25.8 1. Select the Main Menu quick key → from the System column select Maintenance → input the required . password → select 2. Set the Unit tab. 3. Set unit for each parameter. Enabling Auto Daylight Savings Time By default, daylight savings time is disabled. You need to manually enable the daylight savings time.
3. Establish the relationship between the monitor data and hospital’s barcode data for selectable patient demographics. For example, the monitor has an option of Ped for patient category. In your hospital barcode, the text may read as Pediatric. So input Pediatric for the field Ped to establish their relationship. 25.11.2 Setting the Barcode Reader Information To set the barcode reader information, follow this procedure: 1.
25.12 Configuring the Network You can connect the monitor to the central monitoring system (CMS), eGateway, and other monitors through wired LAN or wireless LAN. 25.12.1 Network Safety Information CAUTION • • • • • • • • Wireless network designing, deploying, debugging, and maintenance should be executed by Mindray service personnel or authorized technicians. Always set the wireless network according to local wireless regulations.
3. Input SSID, Security, and Password. 4. Select the WLAN IP tab and select how to get the IP address. 5. ◆ Obtain IP Address Automatically: the monitor automatically gets the IP address. ◆ Use the Following Address: you need to input the IP address, Subnet Mask, and Gateway. Select how to get the DNS address: ◆ Obtain DNS Address Automatically: the monitor automatically gets the DNS address.
3. Select Add Central Station, and then input the CMS name and IP address of this department. 25.12.9 Setting Multicast Parameters Multicast helps device discovery between monitors and other devices on the network. Devices in the same multicast group can be mutually discovered. To set multicast parameters, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2. Select the Network Setup tab→Device Discover tab. 3.
ADT Query is switched off by default. You can load patient information to the monitor from the ADT server only when this function is enabled. After configuring the ADT gateway, select Network Test to verify that the ADT server is properly connected. 25.12.13 Sending Realtime Data, Waveforms and Alarms via HL7 Protocol You can send the realtime data, waveforms, and alarms from the monitor to the hospital servers via HL7 protocol. To do so, follow this procedure: 1.
25.13.1 Setting MLDAP To access the MLDAP server, you should set your monitor as follows: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2. Select the Network Setup tab→ MLDAP tab. 3. Set Server address and port of the MLDAP server. 25.13.2 Testing MLDAP Server Connection To test whether the monitor is properly connected with the MLDAP server, follow this procedure: 1.
25.14 Defining Other Functions 25.14.1 Setting Notch Filter Frequency Set notch filter frequency according to the power line frequency of your country. To set notch filter frequency, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2. Select the Other tab. 3. Set Notch Frequency to 50 Hz or 60 Hz according to the power line frequency. 25.14.2 Setting Mouse Sensitivity The mouse sensitivity is adjustable.
25.14.4 Selecting the Language To set the user interface (UI) language, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2. Select the Other tab 3. Set Language. 25.14.5 Switching On or Off a Parameter If there is no Parameters On/Off tab in the Screen Setup dialog then setting parameter switches is password protected. Follow this procedure to set parameter switches: 1.
26 Battery 26.1 Battery Introduction This monitor is designed to operate on battery power when the mains power is not available. The monitor uses mains power as primary power source. In case of mains power failure, the monitor automatically runs on the battery power. NOTE • 26.2 If the mains power fails and the monitor runs on battery power, the display brightness automatically lowers to the value of Brightness on Battery (set in Screen Setup → Display).
WARNING • • • 26.3.1 Lithium batteries replaced by inadequately trained personnel could result in a hazard (such as excessive temperatures, fire or explosion). Only the smart rechargeable lithium-Ion battery can be installed in the external battery compartment. Ensure that compatible batteries are used for your monitor. For more information, see 26.3.1 Identifying the Battery Type. Otherwise, the monitor may be damaged or cannot work properly.
26.3.3 4. Insert the battery into the battery compartment with the battery terminal inwards. For ePM 15M, you can insert a second battery into the other battery compartment. You can also insert a second battery into the other battery compartment. 5. Turn the latch back to the middle position. 6. Close the battery door.
indicates that no battery is installed or the battery has failed. ■ 26.4.3 Battery-related Alarms When the battery level is low, the monitor presents the Low Battery alarm, the alarm lamp flashes, and the monitor produces an alarm sound. If the battery is almost depleted, the monitor presents the Critically Low Battery alarm. In this case, immediately connect the AC mains to power the monitor and charge the battery. Otherwise, the monitor will automatically shut down soon.
26.7 Storing Batteries When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If batteries are stored for an extended period of time, place the batteries in a cool place with a partial charge of 40% to 60% capacity. Condition the stored batteries every three months. For more information, see 26.6.1 Conditioning the Battery. NOTE • • • 26.
27 Care and Cleaning 27.1 Care and Cleaning Introduction In this chapter we only describe cleaning and disinfection of the main unit, modules and certain accessories. For the cleaning and disinfection of other reusable accessories, refer to their instructions for use of the corresponding accessories. Keep your equipment and accessories clean. To avoid damage to the equipment, follow these guidelines: 27.2 ■ Always follow the manufacturer’s instructions for each cleaning / disinfecting agent.
27.3 Cleaning and Disinfecting the Equipment and Mounting Kits Use approved cleaning and disinfecting agents for cleaning or disinfecting the main unit and modules. 27.3.1 Approved Cleaning and Disinfecting Agents The following table lists approved cleaning and disinfecting agents: Product Name Product Type Active Ingredients Sodium hypochlorite bleach Liquid Sodium hypochlorite bleach 0.
Product Name Product Type Active Ingredients PDI Sani-Cloth® Plus Germicidal Disposable Cloth Wipes n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.125%, n-Alky dimethyl benzyl ammonium chlorides 0.125% PDI Super Sani-Cloth® Germicidal Disposable Wipe n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.25%, n-Alkyl dimethyl benzyl ammonium chlorides 0.25%, Isopropyl Alcohol 55.0% VIRAGUARD Hospital Surface Disinfectant Towelettle Isopropanol 70%, Other ingredients 30% : NOTE • 27.3.
• • 27.4.1 Use only Mindray approved cleaners and disinfectants and methods listed in this section to clean or disinfect the accessories. Warranty does not cover damage caused by unapproved substances or methods. To avoid long term damage, the accessories should be disinfected only when necessary as determined by your hospital’s policy.
The following table lists approved Masimo SpO2 cable cleaning and disinfecting agents: : Product Name Product Type Active Ingredients Isopropanol Liquid Isopropanol 70% The following table lists approved Nellcor SpO2 cable cleaning and disinfecting agents: : 27.4.2 Product Name Product Type Active Ingredients Sodium hypochlorite bleach Liquid Sodium hypochlorite bleach 0.5% Isopropanol Isopropanol 70% 1-Propanol 1-Propanol 50% Virex® TB n-Alkyl dimethyl benzyl ammonium chlorides 0.
27.5 Sterilization Sterilization is not recommended for this equipment, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the products, accessories or supplies.
28 Maintenance 28.1 Maintenance Introduction Regular maintenance is essential to ensure that the equipment continues to function properly. This chapter contains information on periodic testing and maintenance. 28.2 Maintenance Safety Information WARNING • • • • • • • To avoid electric shock, stop using the equipment if you find the housing is damaged, and contact the service personnel.
28.3 Maintenance and Testing Schedule Follow the maintenance and testing schedule or local regulations to perform testing and maintenance such as defined in section 28.5 Testing Methods and Procedures. Follow your hospital policy on cleaning and disinfecting the equipment before testing and maintenance. The following table lists the maintenance and testing schedule: Test/Maintenance Item Recommended Frequency Performance Tests Visual inspection Every day, before first use.
If your monitor needs a safety test and performance test, contact the service personnel. 28.5.1 Performing Visual Inspection Visually inspect the equipment before its first use every day. If you find any signs of damage, remove your monitor from use and contact the service personnel. Verify that the equipment meets the following requirements: 28.5.2 ■ Environment and power supply specifications are met. ■ The monitor housing and display screen are free from cracks or other damage.
28.7 Disposing of the Monitor Dispose of the monitor and its accessories when its service life is reached. Follow local regulations regarding the disposal of such product. WARNING • 28 - 4 For disposal of parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste.
29 Accessories The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the patient monitor. The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. For details about the accessories, refer to the instructions for use provided with the accessory. WARNING • • Use accessories specified in this chapter.
29.1.2 12-Pin Trunk Cables Available for Purchase Model Part No. Description Usage Applicable patient EV6206 009-005266-00 ECG cable, 10' (3.1 m), defibrillationproof, for N/T Reusable Adult/Pediatric EV6207 009-005267-00 ECG cable, 20' (6.2 m), defibrillationproof, for N/T Reusable Adult/Pediatric EV6216 009-005268-00 ECG cable, 10' (3.1 m), ESU-proof, for N/T Reusable Adult/Pediatric EV6217 009-005269-00 ECG cable, 20' (6.
29.1.6 29.1.7 29.1.8 29.1.9 Model Part No. Description Usage Applicable patient EL6301B 0010-30-42734 3-Lead leadset, AHA, snap Reusable Adult/Pediatric EL6311B 040-000146-00 3-Lead leadset, AHA, snap Disposable Pediatric/Neonate EL6311A 040-000148-00 3-Lead leadset, AHA, clip Disposable Pediatric/Neonate 5-lead ECG Leadwires Available for Purchase Model Part No.
29.2 SpO2 Accessories Wavelength emitted by the sensors is between 600 nm and 1000 nm. The maximum photic output consumption of the sensor is less than 18 mW. The information about the wavelength range and maximum photic output consumption can be especially useful to clinicians, for example, when photodynamic therapy is performed. 29.2.1 29.2.2 29.2.3 29 - 4 Extension Cables and Adapter Cables Available for Purchase Model Part No.
29.2.4 29.2.5 29.2.6 Masimo SpO2 LNCS Sensors Also Compatible Model Part No.
Model Part No.
29.4 NIBP Accessories 29.4.1 NIBP Hoses Available for Purchase 29.4.2 Model Part No. Description Usage Applicable patient CM1903 6200-30-09688 NIBP hose, inbuilt connector, 3m Reusable Adult/Pediatric CM1901 6200-30-11560 NIBP hose, inbuilt connector, 3m Reusable Neonate Cuffs Available for Purchase Model Part No.
29.5 IBP Accessories 29.5.1 IBP Accessories Available for Purchase 29.5.2 29.5.3 29.6 29 - 8 Model Part No. Description Usage Applicable patient IM2202 001C-30-70757 12 Pin IBP cable, Argon Reusable / IM2201 001C-30-70759 12 Pin IBP cable, ICU Medical Reusable / IM2211 0010-21-12179 12 Pin IBP cable, Edwards Reusable / IM2204 040-001029-00 IBP extended cable with dualreceptacle Reusable / IBP Accessories Also Compatible Model Part No.
29.7 CO2 Accessories 29.7.1 Sidestream CO2 Accessories Available for Purchase 29.7.2 Model Part No. Description Usage Applicable patient 4000 M02A-10-25937 CO2 Nasal sample cannula, 7'’ line Disposable Adult 4100 M02A-10-25938 CO2 Nasal sample cannula, 7'’ line Disposable Pediatric 4200 M02B-10-64509 CO2 Nasal sample cannula, 7'’ line Disposable Neonatal 60-15200-00 9200-10-10533 Sampling line, 2.5 m Disposable Adult/Pediatric 60-15300-00 9200-10-10555 Sampling line, 2.
29.7.3 29.8 29.9 29 - 10 Mainstream CO2 Accessories Model Part No.
29.10 29.11 Part No. Description 047-004857-00 ID adapter label 047-004859-00 Network line label 009-001770-00 RJ45 connecting cable External Modules Module Part No. Comments C.O. module 115-047283-00 Supports C.O.
29.12 29 - 12 Miscellaneous Accessories Part No. Description 009-001075-00 Power cord, 250 V, 10 A, 3 m, Brazil 009-001791-00 Power cord, 250 V, 16 A, 3 m, South Africa 009-002636-00 Power cord, 10 A, 1.5 m, Australia standard 009-007190-00 Power cord, 3 m, India 009-007191-00 Power cord, 1.8 m, Switzerland 509B-10-05996 Power cord, 10 A, 250 V, 1.
A Product Specifications A.1 Monitor Safety Specifications The monitor is classified, according to IEC 60601-1: A.2 A.3 Degree of protection against electrical shock Type CF defibrillation proof for ECG, Resp, SpO2, NIBP, Temp, IBP, C.O.
NOTE • The environmental specification of unspecified parameter modules are the same as those of the main unit. Main Unit Item Temperature (ºC) Relative humidity (noncondensing) (%) Barometric Operating Condition 0 to 40 15 to 95 427.5 to 805.5 mmHg (57 to 107.4 kPa) -20 to 60 10 to 95 120 to 805.5 mmHg (16 to 107.4 kPa) Item Temperature (ºC) Relative humidity (noncondensing) (%) Barometric Operating Condition 0 to 40 15 to 95 430 to 790 mmHg (57.3 to 105.
A.4 Power Supply Specifications A.4.1 External Power Supply Specifications AC Power A.4.2 Input voltage 100 to 240 VAC (±10%) Input current 2.0 to 0.9 A Frequency 50/60 Hz (± 3 Hz) Battery Specifications Battery LI13I001A Battery LI23S002A Battery LI23I003A Maximum number of batteries configured Run time Type Rechargeable lithium-Ion battery (non-smart battery) Voltage 10.95V Capacity 2600 mAh Type Rechargeable lithium-Ion battery (non-smart battery) Voltage 10.
Charge time Battery LI13I001A (one battery connected) • Battery LI23S002A (one battery connected) • Battery LI23I003A (one battery connected) • Battery LI23I003A (two batteries connected) A.5 A.
A.8 Audio Indicator Speaker A.9 A.10 Give alarm tones (45 to 85 dB), reminder tones, key tones, QRS tones; support PITCH TONE and multi-level tone modulation; alarm tones comply with IEC 60601-1-8. Monitor Interface Specifications AC power input 1 Network connector 1, standard RJ45 connectors, 100 Base-TX, IEEE 802.3 USB connector 2, USB 2.
Amplitude High level: 3.5 to 5 V, ±5%, providing a maximum of 10 mA output current; Low level: < 0.5 V, receiving a maximum of 5 mA input current. Pulse width 100 ms ±10% maximum rising and falling time 1 ms Alarm Output A.11 Alarm delay time from the monitor to remote equipment The alarm delay time from the monitor to remote equipment is ≤2 seconds, measured at the monitor signal output connector.
A.12.2 Wireless baud rate IEEE 802.11b: 1 Mbps to 11 Mbps IEEE 802.11g: 6 Mbps to 54 Mbps IEEE 802.11n: 6.5 Mbps to 72.2 Mbps IEEE 802.11a: 6 Mbps to 54 Mbps Output power <20dBm (CE requirement, detection mode: RMS) <30dBm (FCC requirement: detection mode: peak power) Operating mode Infrastructure Data security Standards: WPA-PSK, WPA2-PSK, WPA-Enterprise,WPA2-Enterprise EAP method: EAP-FAST.
A.12.2.3 Distinct Vision Distance The distinct vision distance between the monitor and the AP is no less than to 50 meters. A.13 Measurement Specifications The adjustable range of alarm limits is the same with the measurement range of signals unless otherwise specified. A.13.1 ECG Specifications ECG A-8 Standards Meet standards of IEC 60601-2-27: 2011 and IEC 60601-2-25: 2011 Lead set 3-lead: 5-lead: 6-lead: 12-lead: ECG standard AHA, IEC Display sensitivity 1.25 mm/mV (×0.125), 2.5 mm/mV (×0.
ESU protection Cut mode: 300 W Coagulate mode: 100 W Recovery time: ≤10 s In compliance with the requirements in clause 202.6.2.101 of IEC 60601-2-27 Pace Pulse Pace pulse markers Pace pulses meeting the following conditions are labelled with a PACE marker: Amplitude: Width: Rise time: No overshoot Pace pulse rejection ±2 to ±700 mV 0.1 to 2 ms 10 to 100 μs (no greater than 10% of pulse width) When tested in accordance with the IEC 60601-2-27: 201.12.1.101.
Tall T-wave rejection capability When the test is performed based on Clause 201.12.1.101.17 of IEC 60601-227, the heart rate calculation is not affected for QRS of 1 mV amplitude and 100 ms duration, T-wave duration of 180 ms and amplitude lower than 1.2 mV, and QT interval of 350 ms. Arrhythmia Analysis Classifications Asystole, V-Fib/V-Tac, V-tac, Vent-.
Differential input impedance >2.5 MΩ Bandwidth 0.2 to 2.5 Hz (-3 dB) Sweep speed 3mm/s, 6.25 mm/s, 12.5 mm/s, 25 mm/s or 50 mm/s, less than 10% error Recovery time <15 s (after defibrillation) Respiration Rate Measurement range 0 to 200 rpm Resolution 1 rpm Accuracy 0 to 120 rpm: ±1 rpm 121 to 200 rpm: ±2 rpm Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s Alarm limit Range (rpm) RR High Adult, Pediatric: RR≤20 RR>20 Neonate: RR≤20 RR>20 RR Low A.13.
PI measurement range 0.02 to 20% 1 The Masimo pulse oximeter with sensors have been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
Response time ≤30 s (normal perfusion, no disturbance, SpO2 value sudden change from 70% to 100%) Recovery time <15 s (after defibrillation) Accuracy 70 to 100%: ±2% (adult/pediatric) 70 to 100%: ±3% (neonate) 0% to 69%: Not specified. When the SpO2 sensor is applied for neonatal patients as indicated, the specified accuracy range is increased by ±1%, to compensate for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. A.13.
Measurement range 30 to300 bpm Resolution 1 bpm Accuracy ±3bpm or ±3%, whichever is greater PR from IBP Module A.13.5 A.13.6 Measurement range 20 to 350 bpm Resolution 1 bpm Accuracy ±1 bpm or ±1%, whichever is greater Temp Specifications Standard Meet the standard of ISO 80601-2-56: 2009 Technique Thermal resistance Operating mode Direct mode Measurement range 0 to 50 °C (32 to 122 °F) Resolution 0.1°C Accuracy ±0.1 °C or ±0.
Accuracy Max mean error: ±5 mmHg Max standard deviation: 8 mmHg Resolution 1mmHg Initial cuff inflation pressure range (mmHg) Adult: 80 to 280 Pediatric: 80 to 210 Neonate: 60 to 140 Default initial cuff inflation pressure (mmHg) Adult: 160 Pediatric: 140 Neonate: 90 Software overpressure protection Adult: 297±3 mmHg Pediatric: 297±3 mmHg Neonate: 147±3 mmHg Static pressure measurement range 0 mmHg to 300 mmHg Static pressure measurement accuracy ±3 mmHg Recovery time <15 s (after defibrillat
Recovery time <10 s (after defibrillation) PPV Measurement range 0% ~ 50% Pressure transducer Excitement voltage 5 VDC, ±2% Sensitivity 5 μV/V/mmHg Zero adjustment range ±200 mmHg Impedance range 300 to 3000Ω Volume displacement <0.
A.13.
Response time For CO2 measurement (without O2 measurement): Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line: ≤5.0 s @ 70 ml/min ≤4.5 s @ 90 ml/min Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line: ≤5.0 s @ 120 ml/min For CO2 measurement (with O2 measurement): Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line: ≤4.5 s@90 ml/min. Measured with a DRYLINE II adult watertrap and a 2.
O2 ≤100 N2O ≤60 Hal ≤4 Sev ≤5 Iso ≤5 Enf ≤5 Des ≤15 ±1 mmHg ±2 mmHg *: means an extra error should be added in case of gas interference when CO2 measurements are performed between 0 to 40mmHg. Effect of interference gases on O2 measurements Gas Quantitative effect CO2 0.2% N2O 0.
Mainstream CO2 Module Standard Meet the standard of ISO 80601-2-55: 2011 CO2 Measurement range 0 to 150 mmHg Accuracy 0 to 40 mmHg: 41 to 70 mmHg: 71 to 100 mmHg: 101 to 150 mmHg: Accuracy drift Meet the requirement for measurement accuracy within 6 hours Resolution 1 mmHg Recovery time <15 s (after defibrillation) Rise time <60 ms Data sample rate 100 Hz awRR measurement range 0 to 150 rpm awRR measurement accuracy ±1 rpm awRR resolution 1 rpm ±2 mmHg ±5% of the reading ±8% of the rea
Full accuracy Gases Range (%REL)1 Accuracy (%ABS) CO2 0≤CO2≤1 110 ±0.1 ±0.2 ±0.3 ±0.5 Not specified N2 O 0 to 20 20 to 100 ±2 ±3 O2 0 to 25 25 to 80 80 to 100 ±1 ±2 ±3 Des 0 to 1 1 to 5 5 to 10 10 to 15 15 to 18 >18 ±0.15 ±0.2 ±0.4 ±0.6 ±1 Not specified Sev 0 to 1 1 to 5 5 to 8 >8 ±0.15 ±0.2 ±0.4 Not specified Enf, Iso, Hal 0 to 1 1 to 5 >5 ±0.15 ±0.
Response time Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line: 120 ml/min: CO2: N2O: O2 : Hal, Iso, Sev, Des, Enf: ≤4 s ≤4.2 s ≤4 s ≤4.4 s Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line: 200 ml/min: CO2: N2O: Hal, Iso, Sev, Des, Enf: O2 : Anesthetic agent limit ≤4.2s ≤4.3s ≤4.5s ≤4s Primary anesthetic agent In full accuracy mode: 0.
EtCO2 High (low limit + 2) to 99 mmHg EtCO2 Low 1 to (high limit - 2)mmHg FiCO2 High 1 to 99 mmHg EtO2 High (low limit + 2%) to 100% EtO2 Low 18% to (high limit - 2)% FiO2 High (low limit + 2%) to 100% FiO2 Low 0% to (high limit - 2)% EtN2O High (low limit + 2) to 100% EtN2O Low 0 to (high limit - 2)% FiN2O High (low limit + 2) to 100% FiN2O Low 0 to (high limit - 2)% EtHal/Enf/Iso High (low limit + 0.2) to 5.0% EtHal/Enf/Iso Low 0 to (high limit - 0.
B EMC and Radio Regulatory Compliance B.1 EMC The device meets the requirements of IEC 60601-1-2: 2014. WARNING • • • • • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. The non-ME EQUIPMENT (e.g.
NOTE • • • • • If the essential performance is lost or degraded, it may be necessary to take mitigation measures, such as re-orienting or relocating the ME EQUIPMENT or ME SYSTEM or shielding the location or stopping using the monitor and contact the service personnel. 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 interfere with this device even though they meet the requirements of CISPR.
Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Conducted disturbances induced by RF fields IEC61000-4-6 3 Vrms 150 kHz to 80 MHz 80% AM at 1 kHz 3Vrms 6 Vrms in ISM bands between 0.
WARNING • The device is configured with a wireless network connector to receive wireless signal. Other devices may interfere with this device even though they meet the requirements of CISPR. Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
WARNING • Changes or modifications not expressly approved by the party responsible compliance could void the user’s authority to operate the equipment.
C Default Settings C.1 ECG, Arrhythmia, ST and QT Default Settings C.1.
C.1.2 Arrhythmia Default Settings C.1.2.
C.1.2.2 C.1.3 Arrhythmia Threshold Default Settings Item Adult Pediatric Neonate Asystole Delay 5 sec 5 sec 5 sec Tachy 120 bpm 160 bpm 200 bpm Brady 50 bpm 75 bpm 100 bpm Extreme Tachy 160 bpm 180 bpm 220 bpm Extreme Brady 35 bpm 50 bpm 60 bpm Multiform PVCs Window 15 beats 15 beats 15 beats PVCs/min 10 10 10 Pause/min 8 8 8 Pause Threshold 2.0 sec 2.0 sec 2.
C.1.4 QT Default Settings Item QTc ΔQTc C.1.
C.2 Respiration Default Settings Item RR Apnea C.3 Default Setting Alarm switch On High limit Adult: 30 Pediatric: 30 Neonate: 100 Low limit Adult: 8 Pediatric: 8 Neonate: 30 Priority Med Alarm Outputs Off Alarm switch On Priority High, unadjustable Alarm Outputs Off Apnea Delay Adult: 20 sec Pediatric: 20 sec Neonate: 15 sec RR Source Auto Resp Lead Adult: Auto Pediatric: Auto Neonate: II Gain ×2 Speed 6.
Item PR Default Setting Alarm switch On High limit Adult: 120 Pediatric: 160 Neonate: 200 Low limit Adult: 50 Pediatric: 75 Neonate: 100 Priority Med Alarm Outputs Off Alarm Source Auto PR Source Auto QRS Volume General, OR: 2 Other departments: 0 Display PR OR: On Other departments: Off C.4 Temperature Default Settings Item TXX (XX refers to temperature site) ΔT C.5 Default Setting Alarm switch On High limit 38.0 °C Low limit 35.
Item NIBP-D NIBP-M NIBP-S Extreme Default Setting Alarm switch On High limit Adult: 90 mmHg Pediatric: 70 mmHg Neonate: 60 mmHg Low limit Adult: 50 mmHg Pediatric: 40 mmHg Neonate: 20 mmHg Priority Med Alarm Outputs Off Alarm switch On High limit Adult: 110 mmHg Pediatric: 90 mmHg Neonate: 70 mmHg Low limit Adult: 60 mmHg Pediatric: 50 mmHg Neonate: 25 mmHg Priority Med Alarm Outputs Off Alarm switch ICU, OR, CCU: On Other departments: Off NIBP-D Extreme High limit Adult: 175 mmH
Item NIBP-M Extreme Default Setting Alarm switch ICU, OR, CCU: On Other departments: Off High limit Adult: 125 mmHg Pediatric: 100 mmHg Neonate: 75 mmHg Low limit Adult: 45 mmHg Pediatric: 40 mmHg Neonate: 20 mmHg Priority High Alarm Outputs Off Initial Pressure Adult: 160 mmHg Pediatric: 140 mmHg Neonate: 90 mmHg Interval OR: 5 min NICU: 30 min Other departments: 15 min Start Mode Clock NIBP End Tone Off Venipuncture Pressure Auto Display Format Sys/Dia (Mean) Nighttime Start Time 22
C.
Item IBP-M Default Setting Alarm switch On High limit ■ Art/Ao/UAP/BAP/FAP/LV/P1-P2 arterial pressure ■ Adult: 110 mmHg Pediatric: 90 mmHg Neonate: 70 mmHg PA ■ Adult: 20 mmHg Pediatric, Neonate: 26 mmHg ICP/RAP/LAP/UVP/P3-P4 venous pressure ■ Adult: 10 mmHg Pediatric, Neonate: 4 mmHg CVP Adult: 14 mmHg Pediatric, Neonate: 5 mmHg Low limit ■ Art/Ao/UAP/BAP/FAP/LV/P1-P4 arterial pressure ■ Adult: 70 mmHg Pediatric: 50 mmHg Neonate: 35 mmHg PA ■ Adult: 0 mmHg Pediatric, Neonate: 12 mmHg CV
Item Art-M Extreme CPP Default Setting Alarm switch Off High limit Adult: 125 mmHg Pediatric: 100 mmHg Neonate: 75 mmHg Low limit Adult: 55 mmHg Pediatric: 40 mmHg Neonate: 30 mmHg Priority High Alarm Outputs Off Alarm switch On High limit Adult: 130 mmHg Pediatric: 100 mmHg Neonate: 90 mmHg Low limit Adult: 50 mmHg Pediatric: 40 mmHg Neonate: 30 mmHg Priority Med Alarm Outputs Off Measure (for P1, P2) All Measure (for P3, P4) Mean only Sensitivity Med Speed 25 mm/sec Scale (
C.7 Item Default Setting Alarm Limit Display On Use PA-D as PAWP Off C.O. Default Settings Item TB Default Setting Alarm switch On High limit 39.0 °C Low limit 36.0 °C Priority Med Alarm Outputs Off Comp const 0.542 Auto Start On Auto TI On C.8 CO2 Default Settings C.8.
C.8.2 Sidestream CO2 Default Settings Item EtO2 FiO2 C.8.3 C.8.
C.
Item EtHal/EtEnf/EtIso FiHal/FiEnf/FiIso EtSev FiSev EtDes FiDes Default Setting Alarm switch On High limit 3.0% Low limit 0.0% Priority Med Alarm Outputs Off Alarm switch On High limit 2.0% Low limit 0.0% Priority Med Alarm Outputs Off Alarm switch On High limit 6.0% Low limit 0.0% Priority Med Alarm Outputs Off Alarm switch On High limit 5.0% Low limit 0.0% Priority Med Alarm Outputs Off Alarm switch On High limit 8.0% Low limit 0.
C.10 C.11 Item Default Setting Scale O2: 400 mmHg CO2: 50 mmHg N2O: 50% Hal, Enf, and Iso: 2.5% Sev: 4.0% AA and Des: 9.
D Alarm Messages D.1 Physiological Alarm Messages This section lists physiological alarms, their default priority, and the actions that can be taken when an alarm occurs. D.1.1 General Physiological Alarm Messages Alarm messages Default priority Cause and solution XX High Med XX Low Med XX value has risen above the high alarm limit or fallen below the low alarm limit. Check the patient’s condition and check if the patient category and alarm limit settings are correct.
Alarm message Default priority Missed Beats Prompt A-Fib Prompt Note: When arrhythmia alarms occur, check the patient’s condition and the ECG connections. D.1.3 D.1.4 D.1.5 D.1.6 D.1.7 D-2 Resp Physiological Alarm Messages Alarm message Default priority Cause and solution Resp Aritifact High The patient’s heartbeat has interfered with his respiration. Check the patient’s condition and the Resp connections.
D.1.8 D.1.9 D.1.10 CO2 Physiological Alarm Messages Alarm message Default priority Cause and solution FiO2 Shortage High FiO2 concentration is less than18%. Check the patient’s condition, the ventilated O2 content and the CO2 connection. AG Physiological Alarm Messages Alarm message Default priority Cause and solution FiO2 Shortage High Check the patient’s condition, the ventilated O2 content and the AG connections.
D.2.2 ECG Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution ECG Noisy Low/Prompt A The ECG signal is noisy. Check for any possible sources of signal noise around the cable and electrode, and check the patient for excessive motion. ECG Amplitude Too Small Low C The ECG amplitude does not reach the detected threshold. Check for any possible source of interference around the cable and electrode.
D.2.5 Alarm message Default priority Indication on alarm reset Cause and solution SpO2 No Pulse Low C The SpO2 sensor failed to obtain pulse signal. Check the patient’s condition and replace the sensor application site. If the alarm persists, replace the sensor. SpO2 Sensor Incompatible Low C Incompatible or an unspecified SpO2 sensor is used. Use specified sensors. SpO2 Low Signal Quality Low C 1. Check the sensor and sensor position. 2. Make sure the patient is not shivering or moving. 3.
D.2.7 Alarm message Default priority Indication on alarm reset Cause and solution NIBP Cuff Overpressure Low A The NIBP airway may be occluded. Check the airway and measure again. If the alarm persists, contact your service personnel. NIBP Timeout Low A The measurement time exceeds 120 seconds in the adult or pediatric mode, or exceeds 90 seconds in the neonatal mode, and the BP value cannot be obtained. Check the patient’s condition and NIBP connections, or replace the cuff and measure again.
D.2.9 CO2 Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution CO2 Module High Temp Low C Ambient temperature is too high or there is a module failure. 1. Lower the operating temperature. 2. Replug the module. 3. If the alarm persists, the CO2 module may fail, contact your service personnel. CO2 Module Low Temp Low C Ambient temperature is too low or there is a module failure. 1. Raise the operating temperature. 2. Replug the module. 3.
D.2.10 Alarm message Default priority Indication on alarm reset Cause and solution CO2 Airway Occluded Low C 1. Check if the sample line is kinked or occluded. 2. Replace the sample line. 3. Replug the module. 4. If the alarm persists, contact your service personnel. CO2 No Filterline Low A Make sure that the filterline is connected. CO2 Calibration Required Low C Perform a calibration. CO2 Airway Error Low C 1. Check if the sample line is kinked or occluded. 2. Replace the sample line.
D.2.11 EWS Technical Alarms Alarm message Default priority Indication on alarm reset EWS param XX is timeout Low A The manually input parameter is timeout. Input a parameter numeric again. EWS score needs to be confirmed Low A Confirm to save or give up current score. Cause and solution XX represents RR, SpO2, Supp. O2, Temp, BP, HR, Consciousness, Blood Sugar, Urine Output, Catheter, Pain Score, Pain, EtCO2, FiO2, Airway, or Customer defined parameter. D.2.
D.2.14 D.2.15 Printer Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution Printer Buffer Full Prompt / The printer buffer is full. Wait till the printer finishes the printing task. Fail Prompt / The printer runs out of paper or cannot be connected. Check the printer. Printing Stopped Prompt / Printing is manually stopped. Printer Unavailable Prompt / The printer may fail. Check the printer.
D.2.16 Other System Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution Storage Card Error High C The storage card fails or files are damaged. Restart the monitor to format the storage card. If the alarm persists, contact your service personnel. Loading Default Config Failed Low A The default configuration is not correctly loaded. The monitor will restore to the factory default configuration for the current patient category.
E SpO2 Sensor Accuracy E.1 The Accuracy of Masimo SpO2 Sensors Table information for the plots below show ARMS values measured with Masimo SET Oximetry Technology in a clinical study.
DCI/DCIP/4050/4051 LNCS YI 4053 E-2
E.2 The Accuracy of Nellcor SpO2 Sensors SpO2 Accuracy for Nellcor Sensors vs. Co-Oximeters (Arms) SpO2 Range 100% to 70% 100% to 90% 90% to 80% 80% to 70% DS-100A 1.64% 1.16% 1.67% 2.25% D-YS, OXI-P/I, OXI-A/N 2.41% 1.38% 2.50% 3.60% MAXAI, MAXPI, MAXII 1.62% 1.49% 1.57% 2.50% MAXNI 1.85% 1.71% 1.51% 1.59% Modified Bland-Altman for SpO2 - MAXAI, MAXPI, MAXII, MAXNI Sensors: (SpO2 - SaO2) vs.SaO2 Modified Bland-Altman for SpO2 - DS-100A Sensors: (SpO2 - SaO2) vs.
Modified Bland-Altman for SpO2 - D-YS, OXI-A/N, OXI-P/I Sensors: (SpO2 - SaO2) vs.
F Units, Symbols and Abbreviations F.
F.
F.
Abbreviation In Full COHb carboxyhemoglobin Compl compliance COPD chronic obstructive pulmonary disease CPI cardiac power index CQI CPR quality index CPO cardiac power output CVP central venous pressure DC direct current Des desflurane Dia diastolic dpi dot per inch dPmx left ventricular contractility DVI digital video interface DO2 oxygen delivery DO2I oxygen delivery index ECG electrocardiograph EDV end-diastolic volume EE energy expenditure EEC European Economic Com
Abbreviation In Full ELWI extravascular lung water index EWS Early Warning Score FAP femoral arterial pressure FCC Federal Communication Commission FDA Food and Drug Administration Fi fraction of inspired FiAA inspired anesthetic agent FiDes inspired anesthetic agent FiEnf FiHal FiIso FiSev FiCO2 fraction of inspired carbon oxygen FiN2O fraction of inspired nitrous oxide FiO2 fraction of inspired oxygen FPGA field programmable gate array FV flow-volume GCS Glasgow Coma Scale GE
F-6 Abbreviation In Full ITBV intrathoracic blood volume LA left arm LAP left atrial pressure LCD liquid crystal display LCW left cardiac work LCWI left cardiac work index LDAP Lightweight Directory Access Protocol LED light emitting diode LL left leg LVET left ventricular ejection time LVSW left ventricular stroke work LVSWI left ventricular stroke work index MAC minimum alveolar concentration MAP mean arterial pressure Mb myoglobin MetHb methemoglobin MEWS Modified Earl
Abbreviation In Full PEF peak expiratory flow PEP pre-ejection period PIF peak inspiratory flow PIP peak inspiratory pressure Pleth plethysmogram Pmean mean pressure PO2 oxygen supply pressure Pplat plateau pressure PPV pulse pressure variation PR pulse rate PVC premature ventricular contraction PVPI pulmonary vascular permeability index PVR pulmonary vascular resistance PVRI pulmonary vascular resistance index qSOFA quick Sepsis-Related Organ Failure Assessment RA right arm
F-8 Abbreviation In Full SSI signal strength index STR systolic time ratio SV stroke volume SVI stroke volume index SVR systemic vascular resistance SVRI systemic vascular resistance index SVV stroke volume variation SvO2 venous oxygen saturation Sync synchronization Sys systolic pressure TB blood temperature tcpCO2 transcutaneous carbon dioxide partial pressures tcpO2 transcutaneous oxygen partial pressures TD temperature difference Temp temperature TFC thoracic fluid cont
Abbreviation In Full VO2I oxygen consumption index VPB ventricular premature beat per minute WOB work of breathing F-9
Caution: This device complies with Part 15 of the FCC rules and Industry Canada license‐exempt RSS standard(s). 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 undesired operation. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications or change to this equipment.
Caution: This device complies with Part 15 of the FCC rules and Industry Canada license‐exempt RSS standard(s). 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 undesired operation. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications or change to this equipment.
