BeneVision N1 Patient Monitor Operator’s Manual
© Copyright 2017-2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. Release time: June 2019 Revision: 7.0 WARNING • Federal Law (USA) restricts this device to sale by or on the order of a physician or other practitioner licensed by U.S. state law to use or oder the use of this device.
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 copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information.
Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
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 your product. If you have any question, please contact us. This manual is an integral part of the product.
Contents 1 Safety .................................................................................................................................................................................. 1 - 1 1.1 Safety Information ..........................................................................................................................................................................................1 - 1 1.1.1 Warnings ...............................................................................
3.4.2 Connecting the Input Devices .....................................................................................................................................................3 - 3 3.4.3 Installing the External Parameter Module ...............................................................................................................................3 - 3 3.4.4 Turning on the Monitor .................................................................................................................
3.14.4 Setting OxyCRG Parameters .................................................................................................................................................... 3 - 19 3.14.5 Setting the Threshold of ABD Events ................................................................................................................................... 3 - 19 3.14.6 Editing ABD Events ...................................................................................................................
6.5 Using the ADT Gateway ................................................................................................................................................................................6 - 2 6.6 Sending Realtime Data, Waveforms and Alarms via HL7 Protocol ...............................................................................................6 - 2 6.7 Viewing Other Patients (Only available for the independent external display) .........................................................
7.8.3 Setting Alarm Light Status on Alarm Reset .......................................................................................................................... 7 - 12 7.9 Latching Alarms ............................................................................................................................................................................................ 7 - 12 7.10 CPB Mode ........................................................................................................
8.7.2 Enabling ST Monitoring ............................................................................................................................................................... 8 - 15 8.7.3 Displaying ST Numerics ............................................................................................................................................................... 8 - 16 8.7.4 Displaying ST Segments in the Waveform Area ......................................................................
10.5.1 Setting the Resp Alarm Properties ........................................................................................................................................ 10 - 4 10.5.2 Setting the RR Source ................................................................................................................................................................ 10 - 4 10.5.3 Choosing the Respiration Lead .............................................................................................
.2 NIBP Safety Information .......................................................................................................................................................................... 13 - 1 13.3 NIBP Measurement Limitations ............................................................................................................................................................ 13 - 2 13.4 Measurement Modes ....................................................................................
.7.2 Preparing to Measure PAWP ................................................................................................................................................... 14 - 8 14.7.3 Measuring PAWP ......................................................................................................................................................................... 14 - 8 14.7.4 Setting the Waveforms of the PAWP Screen .............................................................................
16.2.1 Accessing the Review Page ..................................................................................................................................................... 16 - 1 16.2.2 Example Review Page ................................................................................................................................................................ 16 - 1 16.2.3 Symbols on Review Pages ................................................................................................
18.4 Hemodynamic Calculations ................................................................................................................................................................... 18 - 3 18.4.1 Performing Hemodynamic Calculations ............................................................................................................................. 18 - 3 18.4.2 Input Parameters for Hemodynamic Calculations ..................................................................................
20.4.4 Battery-related Alarms ............................................................................................................................................................... 20 - 2 20.4.5 Checking the Battery Information ......................................................................................................................................... 20 - 3 20.5 Charging the Battery ........................................................................................................
23.4 NIBP Accessories ........................................................................................................................................................................................ 23 - 6 23.4.1 NIBP Hoses .................................................................................................................................................................................... 23 - 6 23.4.2 Cuffs ...............................................................................
B.1 EMC ......................................................................................................................................................................................................................B - 1 B.2 Radio Regulatory Compliance ....................................................................................................................................................................B - 4 C Default Settings ...............................................................
E.2 Device Enclosure and Accessories .............................................................................................................................................................E - 1 E.2.1 Visual Inspection ................................................................................................................................................................................E - 1 E.2.2 Contextual Inspection ..............................................................................
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 to ensure that you get the most from your product.
• • 1.1.2 The equipment should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptom. If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check the equipment for proper functioning. The software equipment copyright is solely owned by Mindray.
Symbol Description Symbol Description Serial number Catalogue number Date of manufacture Manufacturer USB connector Protected against vertically falling water drops per IEC 60529 IP44: protected against ingress of foreign objects no less than 1.0 mm, and against access to hazardous parts with wire; protect against harmful effects of splashing water IP22: protected against ingress of foreign objects no less than 12.
Symbol Description Symbol Description Stand-by Input/output Humidity limitations Atmospheric pressure limitations Temperature limitations Non-ionizing electromagnetic radiation Dispose of in accordance to your country’s requirements Authorised representative in the European Community The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfil the essential requirements of Annex I of this directive.
2 Equipment Introduction 2.
(1) Alarm lamp: When a physiological alarm or technical alarm occurs, this lamp lights and flashes corresponding with the alarm priority: • (2) 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. Ambient light sensor When screen brightness is set to auto, the system automatically adjusts screen brightens according to the strength of ambient light.
2.3.3 Right View (2) (1) (3) (4) (9) (5) (8) (6) (7) 2.3.4 (1) Power switch (2) Sample line connector of the sidestream CO2 (3) Gas outlet (4) ECG cable connector (5) SpO2 sensor connector (6) NIBP cuff connector (7) Multifunctional connector: outputting analog and defib synchronization signal. (8) IBP cable connector (9) Temperature probe connector Bottom View (1) (2) (1) 2.4 (1) Clip: fasten the N1 when N1 is in use with the host monitor, Dock or Modular Rack.
2.4.1 Left View (1) (2) 2.4.2 (1) Release button: pressing this button releases the Modular Rack from the Dock. (2) Multi-pin connector: connects the Modular Rack and Dock. Right View (1) (2) (3) 2.5 (1) Multi-pin connector: connects the Modular Rack and N1. (2) Infrared filter: used for communication between the Modular Rack and external parameter module. (3) Contact: power input connector of the external parameter module. Dock Dock is used to connect the N1 or Modular Rack.
2.5.1 Left View (1) (1) 2.5.2 Symbol: indicates the direction and angle that Dock can rotate when Dock is fixed onto a transverse or a vertical rod. Right View (1) (3) (2) (1) Multi-pin connector: power input and communication connector of the N1. (2) Connection status LED: it is on when the N1 is properly connected to the Dock. (3) External power LED: it is on when the external AC power supply is connected.
2.5.3 Rear View (1) 2.6 (2) (3) (4) (5) (6) (1) AC Power input connector (2) Equipotential grounding terminal: when using the monitor together with other devices, connect their equipotential grounding terminals together to eliminate the potential difference between them. (3) VGA connector: connects the external display (4) Host monitor connector: connects the N1 to the host monitor. (5) USB connector: connects USB devices. (6) Network connector: a standard RJ45 connector.
2.7 Installlation 2.7.1 Installing the N1 or External Parameter Module into the Modular Rack You can install the N1 and an external parameter module, if needed, to the Modular Rack as indicated below: Firmly push the N1 or the external module until you hear that the clip (refer to 2.3.4 Bottom View) engages the Modular Rack. To ensure that the N1 or the external module is properly connected, try to pull the N1 or the external module outward.
2.7.3 Installing the Modular Rack to the Dock The Modular Rack can be installed to the Dock as indicated below: You hear a click when the Modular Rack is pushed into place. 2.7.4 Removing the Modular Rack from the Dock To remove the Modular Rack from the Dock, follow this procedure: 1. Press and hold down the release button at the top of the Modular Rack. 2. Pull the Modular Rack out as indicated. . 1 2 CAUTION • 2.7.
Firmly push N1 until you hear that the clip (refer to 2.3.4 Bottom View) engages the Dock. To ensure that N1 is properly connected, try to pull N1 outward. N1 properly engages the Dock if you cannot pull it out. 2.7.6 Removing the N1 from the Dock To remove the N1 from the Dock, follow this procedure: 1. Press and hold the latch at the bottom of N1. 2. Pull the N1 out as indicated. 2 1 2.
CAUTION • 2.8.1 If you need the analog signals, use the multifunctional connector of the N1 instead of the Micro-D connector of the BeneView T series monitor when the two monitors are connected. Connecting N1 to the Host Monitor through the Module Rack To connect the N1 to the module rack of the host monitor, follow this procedure: 1. Insert N1 to the host monitor’s module rack. Firmly push N1 until you hear that the clip (refer to 2.3.4 Bottom View) engages the module rack. 2.
2.9 1. Connect the N1 to the Dock. 2. Connect the host monitor connector of the Dock with the SMR connector of the host monitor using the dock data cable. N1 in Use with the Transport Dock N1can be used together with the Transport Dock to transport patient through road ambulance, airplane fuselage or helicopter fuselage. For the installation of the N1 and Transport Dock, refer to the Transport Dock Indication for Use (PN: H-046-011365-00). WARNING • • • • 2.
3 Getting Started 3.1 Equipment Preparation Safety Information WARNING • • • • • Use only installation accessories specified by Mindray. 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. Connect only approved devices to this equipment.
NOTE • 3.3 If your monitor contains the internal CO2 module, connect the CO2 adapter to the CO2 receptacle soon after you unpack the monitor to avoid losing the CO2 adapter. Environmental Requirements The operating environment of the equipment must meet the requirements specified in this manual. The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances.
• • • 3.4.2 Use the cable retainer to secure the power cord to prevent it from falling off. Use AC power source when the N1 is in use with the Dock. Use the battery if the integrity of the protective earth conductor or the protective earthing system in the installation is in doubt. Connecting the Input Devices Connect the mouse, keyboard, and barcode scanner if necessary. 3.4.3 Installing the External Parameter Module If external parameter module is needed, refer to section 2.7.
. To unlock the touchscreen, touch anywhere When the touchscreen is locked, the quick key changes to of the touchscreen and swipe the slider up as instructed. NOTE • 3.5.2 Wipe off the water on the touchscreen in case of rain or water spray. Using the Mouse You can use the mouse to select a screen element by moving the cursor on the element and then click on it.The mouse sensitivity is adjustable. To do so, follow this procedure: 3.5.3 1.
barcode, the text may read as Pediatric. You need to input Pediatric for the field Ped to establish their relationship. 3.5.4.3 Setting the Barcode Reader Information To set the barcode reader information, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2. Select the Scanner tab → Scanner Info. tab. 3.
(1) (2) (3) (5) (4) (6) (10) (7) (9) (8) 3.6.1 (1) Patient information area: displays patient category and gender. The displayed patient information is configurable. Selecting this area enters the Patient Management menu. For more information, see 4.3Managing Patient Information. (2) Patient information area: displays patient information, including department, room number, bed number, and so on. The displayed patient information is configurable.
Symbol Description Symbol Description Neonate, male Neonate, female Wireless network is connected. The solid part indicates network signal strength. Wireless network is not connected. Wired network is connected. Wired network is not connected. All the alarms are paused. Individual physiological alarms are turned off or the monitor is in the alarm off status. Audible alarm tones are paused. Audible alarm tones are turned off. Alarms are acknowledged and the alarm system is reset.
3.6.3 (3) Operation buttons (4) Exit button: closes the current menu page. (5) Main body area: includes menu items and options. (6) Switch: ◆ Green: the switch is on. ◆ Gray: the switch is off. Quick Keys of the N1 The monitor provides quick keys for you to quickly access some functions. The quick key area is located at the right of the screen. The quick key area displays 5 quick keys. You can also swipe down on the quick key area for more quick keys.
Symbol Label Function NIBP Start/ Stop Label Function Starts an NIBP measurement or stops the current NIBP measurement. Manual Event Manually triggers and saves an event. NIBP Measure Enters the NIBP Measure menu. Main Menu Enters the main menu. Alarm Setup Enters the Alarm menu. More Shows more quick keys. Discharge Patient Enters the Discharge Patient dialog box. Patient Demographics Enters the Patient Management menu. Review Enters the Review menu.
Symbol 3.6.5 Label Function GCS Enters the GCS menu. Symbol Label Function Rescue Mode Enters the rescue mode. Configuring the Displayed Quick Keys (only available for the independent external display) To select the quick keys you want to display, follow this procedure: 1. 3.7 Access Quick Key in either of the following ways: ◆ Select the Screen Setup quick key → the Select Quick Keys tab. ◆ Select the Main Menu quick key → from the Display column select Quick Keys. 2.
3.7.3.1 Entering the Privacy Mode To enter the privacy mode, select the Main Menu quick key → from the Display column select Privacy Mode → select Ok. The monitor has the following features after entering the privacy mode: ■ The screen turns blank. ■ Except for the low battery alarm, the monitor inactivate alarm tone and alarm light of all other alarms. ■ The monitor suppresses all system sounds, including heart beat tone, pulse tone, and prompt tone. WARNING .
1. Select the Main Menu quick key → from the Display column select Exit Night Mode. 2. Select Ok. NOTE • • 3.7.5 If your monitor is connected to the CMS, it automatically exits the night mode when being disconnected from the CMS. The monitor resumes the previous settings after exiting the night mode. Standby Mode You can temperately stops patient monitoring without switching off the monitor by entering the standby mode. 3.7.5.1 Entering the Standby Mode 1.
3. 3.7.6.2 Set Enter Outdoor Mode to Manual or Auto. ◆ Manual: The monitor enters the outdoor mode by manually selecting the Main Menu quick key → from the Display column select Enter Outdoor Mode. ◆ Auto: The monitor enters the outdoor mode automatically if the strength of ambient light is greater than the threshold. Exiting the Outdoor Mode When Enter Outdoor Mode is set to Manual, select the Main Menu quick key → from the Display column select Exit Outdoor Mode.
NOTE • 3.8.4 If you enable Auto Daylight Saving Time, you cannot manually switch it on or off from the System Time menu. For more information, see 3.8.2Setting the Date and Time. Setting the Unit To set the unit, follow this procedure: 3.8.5 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 measurement units for each parameter.
2. ◆ Select the Screen Setup quick key → select the Parameters On/Off tab. ◆ Select the Main Menu quick key → from the Parameters column select Parameters On/Off. Switch on or off desired parameters. When a parameter is switched off, the monitor stops data acquisition and alarming for this measurement. NOTE • 3.11.2 When a parameter is manually switched off, you cannot monitor this parameter even if the related accessories of this parameter are connected.
1. 3.11.6 Access Choose screen in either of the following ways: ◆ Select the Screen Setup quick key. ◆ Select the Main Menu quick key → from the Parameter column select Choose screen. 2. Select Big Numerics. 3. Select Big Numerics tab. 4. Select a parameter numeric area or waveform area, and then from the popup list select an element you want to display in this area. Changing Measurement Colors You can set the color of measurement values and waveforms for each parameter.
3.13 Using the External Display The N1 can be connected to an external display through the VGA connector of the Dock. When the external display is connected, you can monitor a patient either through the N1 or through the external display. The external display configured as independent display can display differently with the N1. For the configuration of the independent external display, see section 3.13.2Setting the External Display.
3.13.3 External Display Troubleshooting Problem Corrective Actions Image offset Adjust the external display by using the auto adjust function or adjust the external display manually. No image or the image displays abnormally • Check that the external display is properly connected to the AC mains and is powered on. • Check that the VGA cable is properly connected. • Remove the N1 from the Dock and reconnect it if the problem persists.
3.14.3 The Display of the ABD Event Area The ABD event area displays parameter values of currently active OxyCRG events and lists the latest red ABD events. 3.14.4 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. 3.14.
4 Managing Patients 4.1 Discharging a Patient Before monitoring a new patient, discharge the previous patient. After the patient is discharged, all patient data, including patient information, trend data, and physiological alarm information is be deleted from the monitor. The technical alarms is reset, and monitor settings returns to their defaults. For more information, see 5.3 Setting Default Configuration. After a patient is discharged, the monitor automatically admit a new patient.
4.2 Admitting a Patient The monitor admits a new patient in the following situations: ■ After a patient is manually discharged, the monitor automatically admit a new patient. ■ After being switched off for the selected time period, the monitor automatically discharge the previous patient and admit a new patient at startup.
4. 4.3.4 Select a patient from the patient list, and then select Import. Corresponding patient information in the monitor will be updated. Loading Patient Information from the ADT Server If the monitor is connected with the Admit-Discharge-Transfer (ADT) server through the eGateway. You can load patient information from ADT server to the monitor. To do so, follow this procedure: 1.
4.3.8 Setting Monitor Location If your monitor is installed at a fixed position, or you do not need to frequently change the room number and bed number, you can set Monitor Location to Fixed. To set the monitor location, follow this procedure: 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. Set Location. 4. ◆ Fixed: the Patient Management menu displays Bed No. and Room No.
• After a patient is successfully transferred, check if the patient settings (especially patient category, paced status, alarm limits settings, and etc) on the monitor are appropriate for this patient. NOTE • 4.5 The system automatically switches on the HR alarm and lethal arrhythmia alarm after transferring the patient data. Setting the Dock After the N1 is transferred to the target location, connecting the N1 to a Dock enables N1 to use the settings of the Dock.
4.5.3.2 Setting the Wired Network The wired networking is available as long as N1 is connected to the Dock. To set the wired network, follow this procedure: 4.5.3.3 1. Connect the N1 to the Dock. 2. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 3. Select the Dock Setup tab→ select the Setup tab. 4. Set the Work Mode to Host Mode. 5. Select the IP tab. 6. Set Network Type to LAN1 IP. 7.
■ The monitor can transmits parameter values, waveforms, alarm settings, and events to the CMS. From the CMS, you can check the patient’s monitoring data and alarms. ■ Patient information, alarm settings, and alarm status can be synchronized between the monitor and the CMS. ■ You can start or stop NIBP measurements from the CMS. ■ In case of network disconnection, the monitor can transmit the offline data to the CMS when network is reconnected.
5 Managing Configurations 5.1 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.
To set the default configuration, follow this procedure: 5.4 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. ◆ When you select Load Specified Config, the restored configuration is subject to the patient category (adult, pediatric or neonate). This configuration can be either factory configuration or a saved user configuration.
5.6.2 Importing a Configuration To import the configuration from the USB drive to the monitor, follow this procedure: 5.7 1. Connect the monitor to the Dock. 2. Connect the USB drive to the Dock’s USB port. 3. Select the Main Menu quick key →from the Configuration column select Manage → input the required password → select . 4. Select Import Configuration. 5. Select the configurations and User Maintenance Settings to import. 6. Select Import.
6 Networked Monitoring 6.1 Network Introduction You can connect the monitor to the central monitoring system (CMS), and eGateway through wired LAN or wireless LAN. 6.2 Network Safety Information CAUTION • • • • • • • • 6.3 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.
6.4 3. Enable the Select CMS. 4. Select the system status information area at the top right corner of the screen. Connecting the eGateway You can connect the monitor to the eGateway to implement interaction between the monitor and external devices. When connected to the eGateway, the system provides the following functions: 6.5 ■ The monitor can transmit parameter values, waveforms, alarm settings, and events to the eGateway. ■ Clock can be synchronized between the monitor and the eGateway.
6.7.1 Remote View In the Remote View window, you can view real time parameters and waveforms from one specific device, and watch the alarms of other monitored devices at the same time. 6.7.1.1 Entering the Remote View Window To enter the Remote View window, choose one of the following ways: 6.7.1.2 ■ Select the Remote View quick key. ■ Select the bed at the alarm watch tile on the main screen. For more information, see 6.7.2.
(2) Main body Display the patient’s information, alarm status and messages, waveforms, measurements, etc. of the selected bed. This bed is called main bed. 6.7.1.3 Adding a Bed You need to add the desired remote devices, and then the alarms from these devices can be watched on your monitor. To add a remote device, follow this procedure: 1. Enter the Select Bed window. To do so, choose either of the following ways: ◆ In the Remote View window, select Select Bed. For more information, see 6.7.1.
6.7.2 Alarm Watch The alarm watch function provides the alarm notification by color and sound. 6.7.2.1 ■ The monitor sounds the highest priority alarm tone from all the monitored remote devices. ■ The moitor displays the highest priority alarm in corresponding background color for each bed at following areas: ◆ At the top of the Remote View. For more information, see 6.7.1.2 About the Remote View for details. ◆ On the main screen. For more information, see 6.7.2.
6.8 Configuring the Network 6.8.1 Setting the Wireless Network To set the wireless network of the N1, 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 → WLAN. 3. Input SSID, Security, and Password. 4. Select the WLAN IP tab and select how to get the IP address. ◆ Obtain IP Address Automatically: the monitor automatically gets the IP address.
3. 6.8.5 Select Certification Management from the bottom left corner of the menu. ◆ From the Local tab, select certifications you want to delete from the monitor, and then select Delete. ◆ From the USB Drive tab, select certifications you want to import from the USB memory, and then select Import. Setting Multicast Parameters Multicast helps device discovery between monitors and between monitors and CMS. Devices in the same multicast group can be mutually discovered.
6.9 MLDAP MLDAP refers to Mindray LDAP (Lightweight Directory Access Protocol). It is an independent process which can be installed on eGateway or other application server (Windows). MLDAP provides user identity and authentication. The MLDAP server is connected with the hospital LDAP server. All monitoring devices are connected to the MLDAP server to implement identity and authentication for the following operations: 6.9.
From the Others area, selecting Modify Local Password can change the monitor’s password for accessing alarm settings and arrhythmia settings. 6.9.4 Setting the Password Timeout Period If you use the password saved in the MLDAP server to access the Maintenance menu, alarm settings and arrhythmia settings, you can set the password timeout period. If the timeout period is reached, you need to reenter the password. To do so, follow this procedure: 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 your monitor is connected to the central monitoring system (CMS) or other monitors, alarms can be presented and controlled remotely.
7.3.2 Alarm Priorities By severity, the alarms are classified into the following priority levels: 7.3.3 ■ High priority alarms: indicates a life threatening situation or a severe device malfunction. High priority alarms require an immediate response. ■ Medium priority alarms: indicates abnormal vital signs or a device malfunction. Medium priority alarms require a prompt response. ■ Low priority alarms: indicate a discomfort condition, a device malfunction, or an improper operation.
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.
7.6.2 Setting Alarm Tone Properties 7.6.2.1 Changing the Alarm Volume To change the alarm volume, follow this procedure: 1. Select the Main Menu quick key → from the Alarm column select Setup. 2. Set Alarm Volume. The optional alarm volume is between X to 10, in which X is the minimum volume, depending on the setting of minimum alarm volume, and 10 is the maximum volume. 3. Select High Alarm Volume to set the volume of the high priority alarm. 4.
To set the reminder tone, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select 7.6.2.6 . 2. Select the Alarm tab → Pause/Reset tab. 3. Set Alarm Reset Reminder. ◆ On: the monitor issues reminder tones at a designated interval. ◆ Re-alarm: if the alarm condition persists the acknowledged alarms marked with “√” will be regenerated after the designated reminder tone interval .
Lower Limit Module ECG Resp Parameter Adult/ pediatric Neonate HR/PR (bpm) HR × 0.8 or 40 (whichever is greater) RR (rpm) Auto Limit Range Adult/ pediatric Neonate (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 × 0.5 or 6 (whichever is greater) (RR - 10) or 30 (whichever is greater) (RR × 1.
Lower Limit Module 7.6.4 Parameter Upper Limit Auto Limit Range Adult/ pediatric Neonate Adult/ pediatric Neonate IBP: CVP/ LAP/ RAP/ UVP/P1P4 (Venous pressure) IBP-M Mean × 0.75 Mean × 0.75 Mean × 1.25 Mean × 1.
7.6.5 Adjusting the Alarm Light Brightness To adjust the alarm light brightness, 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 → Other tab. 3. From the Alarm Light Brightness block, set Primary Display. If you set alarm light brightness to Auto, the monitor automatically adjusts the alarm light brightness according to the ambient light.
2. Select the Alarm tab → select the Other tab. 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 • • 7.6.10 If you switch 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. Always keep the patient under close surveillance.
When the alarm pause time expires, the alarm paused status is automatically deactivated. You can also cancel the alarm paused status by pressing the Alarm Pause quick key. 7.7.2.1 Setting the Alarm Pause Time The alarm pause time can be set to 1 min, 2 min, 3 min, or Permanent. The default alarm pause time is 2 min. To set the alarm pause time, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select 7.7.2.2 . 2.
WARNING • 7.7.3 Pausing or switching off alarms may result in a hazard to the patient. Pausing Alarm Sound If the pause function is defined as Audio Pause, pressing the Audio Pause key pauses alarm tone. When alarm tones are paused, the following rules are followed: ■ The sound of all physiological alarms and technical alarms are switched off. ■ The remaining audio pause time is displayed in the physiological alarm information area.
7.8.1 Resetting Physiological Alarms Physiological alarms give different alarm indicators when the alarm system is reset: 7.8.2 ■ The alarm sound is silenced. ■ A √ appears before the alarm message, indicating that the alarm is acknowledged. ■ The color of the parameter numeric background corresponds with the alarm priority, but the parameter numeric does not flash.
NOTE • • 7.10 Changing alarm priority may affect the latching status of corresponding alarm. Determine if you need to adjust the latching status for the specific alarm when you have changed its alarm priority. When the alarm system is reset, latched physiological alarms are cleared. CPB Mode The CPB (Cardiopulmonary Bypass) mode is activated only if you set the department to OR. In the CPB mode, all the physiological alarms and technical alarms are switched off.
7.12 Managing Alarms from Remote Devices (only available for the independent external display) You can view and manage the alarms coming from remote devices, for example bedside monitors and telemetry monitors on your monitor. 7.12.1 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.
7.12.4 Resetting Alarms for Remote Devices You can reset the alarms occuring to the remote devices at your 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’s Alarms. Then the Alarm Reset button appears on the bottom left of the Remote View window. To reset remote device alarms, select Alarm Reset.
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, and QT/QTc measurements. ECG monitoring is intended for adult, pediatric, and neonatal patients. 8.2 ECG Safety Information WARNING • • • • • • This equipment is not intended for direct cardiac application.
8.3 ECG Display The following figures show the ECG waveform and numeric areas. Your display may be configured to look slightly different. (1) (2) (3) (4) (5) (6) (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.
• 8.4.3 When applying the electrodes, avoid bony area, obvious layers of fat, and major muscles. Muscle movement can result in electrical interference. Applying electrodes on major muscles, for example on muscles of the thorax, may lead to erroneous arrhythmia alarms due to excessive muscle movement. Lead Wire Color Code The following table lists the color coding of leadwires for both AHA and IEC standards: IEC AHA Lead 8.4.
8.4.4.2 5-leadwire and 6-leadwire Electrode Placement The following is an electrode configuration when when 5-leadwires is used: ■ RA placement: directly below the clavicle and near the right shoulder. ■ LA placement: directly below the clavicle and near the left shoulder. ■ RL placement: on the right lower abdomen. ■ LL placement: on the left lower abdomen. ■ V placement: on the chest. For 6-leadwire placement, you can use the position for the 5 -leadwire placement but with two chest leads.
8.4.4.4 10-leadwire Electrode Placement 12-lead ECG uses 10 electrodes, which are placed on the patient’s four limbs and chest. The limb electrodes should be placed on the limb extremities and the chest electrodes placed according to the physician’s preference. The picture at the right shows the conventional 10-leadwire electrode placement. 8.4.4.5 Lead Placement for Surgical Patients The surgical site should be taken into consideration when placing electrodes on a surgical patient.
You can also change the patient’s paced status from the Patient Management menu. For more information, see 4.3.1 Entering the Patient Management Menu. If you did not set the paced status, the monitor issues a prompt tone when pace pulse is detected. At the same time, the paced symbol flashes and the message Please check if the patient has a pacemaker? appears in the ECG waveform area. Check and set the patient’s paced status. WARNING • • • • • 8.4.7 For paced patients, you must set Paced to Yes.
2. Select the Alarm tab. 3. Enter the password if required. For more information, refer to 6.9.3 Selecting Password for User Authentication. 4. Set alarm properties as desired. 8.5.3 Changing ECG Wave Settings 8.5.3.1 Selecting the Leads of Displayed ECG Waveforms To select the leads of displayed ECG waveforms, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG menu. 2. Select the Setup tab. 3. Select ECG to set the lead of each ECG waveform. 4.
8.5.3.5 Setting the ECG Filter To set the ECG waveform filter mode, follow this procedure: 8.5.3.6 1. Select the ECG numeric area or waveform area to enter the ECG menu. 2. Select the Setup tab. 3. Set Filter. ◆ Diagnostic: use when diagnostic quality ECG is required. The unfiltered ECG waveform is displayed so that changes such as R-wave notching or discrete elevation or depression of the ST segment are visible. ◆ Monitor: use under normal measurement conditions.
8.5.6 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. Adjusting the QRS Volume To adjust the QRS volume, follow this procedure: 1. Select the ECG numeric area or waveform area to enter the ECG menu. 2. Select the Setup tab. 3. Set QRS Volume.
8.6.1 Arrhythmia Safety Information WARNING • • • • Heart rate reading may be affected by cardiac arrhythmias. Do not rely entirely on heart rate alarms when monitoring patients with arrhythmia. Always keep these patients under close surveillance. The arrhythmia analysis program is intended to detect ventricular arrhythmias and atrial fibrillation. It is not designed to detect all the atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an arrhythmia.
Arrhythmia message Description PVC One PVC detected in between normal beats. Bigeminy A dominant rhythm of N, V, N, V, N, V. Trigeminy A dominant rhythm of N, N, V,N, N, V, N, N, V. Tachy The heart rate is greater than the tachycardia limit. Brady The heart rate is lower than the bradycardia limit. Pacer not Capture No QRS complex detected for 300 ms following a pace pulse (for paced patients only). Pacer not Pacing No pace pulse detected for 1.
NOTE • • 8.6.4.2 You can switch off lethal arrhythmia alarms only when you have enabled Lethal Arrhys Off. For more information, see 8.6.4.2 Setting the Lethal Arrhythmia Alarms Switch. The priority of lethal arrhythmia alarms is always high. It cannot be altered. Setting the Lethal Arrhythmia Alarms Switch To disable the arrhythmia alarms, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select . 2.
8.6.4.5 Arrhythmia Threshold Range Extreme Brady 15bpm to 115 bpm Multif PVCs Window 3 beats to 31 beats V-Tach Rate 100 bpm to 200 bpm V Brady Rate 15 bpm to 60 bpm V-Tach PVCs 3 beats to 99 beats V Brady PVCs 3 beats to 99 beats PVCs/min 1 to 100 Pauses/min 1 to 15 Pause Threshold 1.5sec, 2.0sec, 2.5sec, 3.
8.6.5 ■ If the number of consecutive PVCs is lower than the V-Tach PVCs limit (6) but greater than 2, and PVC rate is greater or equal to the V-Tach Rate limit (130), a Nonsus V-Tach alarm is generated. ■ If the number of consecutive PVCs is greater than or equal to the V Brady PVCs limit (5), and PVC rate is lower than the V Brady limit (40), a Vent Brady alarm is generated.
From the Other block, set Arrhy Shield Time. The arrhythmia alarm timeout period is two minutes by default. To disable this function, set Arrhy Shield Time to 0. NOTE • • • 8.6.5.3 For the following alarms, alarm light and alarm tone cannot be disabled: HR high, HR low, Tachycardia, Bradycardia, Afib End, Irr. Rhythm End. The timeout period is only applicable to the alarms in the medium priority chains and atrial fibrillation chain.
2. Select the ST tab→ select the Setup tab. 3. Switch on ST Analysis. Reliable ST monitoring cannot be ensured under the following situations: ■ You are unable to get a lead that is not noisy. ■ Arrhythmias, such as atrial fib or flutter, cause irregular baseline. ■ The patient is continuously ventricularly paced. ■ The patient has left bundle branch block. In these cases, you may consider switching off ST monitoring. 8.7.
2. Select the waveform area where you want to display the ST segments, and then select ST→ ST Segment. The waveform area displays the current and baseline ST segments. It also displays the current and baseline ST values. In the following picture, the current ST segment and value are in green, while the baseline ST segment and value are in white.
3. From the bottom of the menu, select ST Graphic.The following figure shows the ST Graphic when ST Alarm Mode is set to Absolute. The height of the bar indicates the ST value of corresponding ST lead. The color of the bar indicates ST alarm status: green indicates that corresponding ST value is within alarm limits; cyan, yellow and red indicate that the ST value exceeds the alarm limits. The color matches ST alarm priority. The following figure shows the ST Graphic when ST Alarm Mode is set to Relative.
3. 8.8.1.2 Set ST Alarm Delay. Changing Leads for ST Display The monitor automatically selects the three most deviated leads for ST display. You can also manually select the leads. To do so, follow this procedure: 8.8.1.3 1. Select the ST numeric area, ECG numeric area or ECG waveform area to enter the ECG menu. 2. Select the ST tab → select the Setup tab. 3. Set ST Segment. You can select up to 3 leads.
8.8.2.2 Setting ST Point, ISO Point, and J Point CAUTION • • You need to adjust the ST points before starting monitoring, or if the patient's heart rate or ECG morphology changes significantly, as this may affect the size of the QT interval and thus the placement of the ST point. Artifactual ST segment depression or elevation may occur if the isoelectric point or the ST point is incorrectly set. Always make sure that the positions of ST points are appropriate for your patient.
If the heart rate is extremely high (over 150bpm for adults and over 180bpm for pediatrics and neonates), QT will not be measured. When the heart rate changes, it can take several minutes for the QT interval to stabilize. For reliable QTc calculation it is important to avoid measurements when the heart rate is changing. 8.9.2 Enabling QT/QTc Monitoring The QT monitoring function is disabled by default. Before you start QT monitoring, enable the QT function. To do so, follow this procedure: 8.9.3 1.
The following picture shows the QT view. ■ The current waveform is shown in the upper half in green. ■ The baseline waveform is shown below in white. ■ The start of QRS complex and the end of the T wave are marked with a vertical line. ■ In some conditions, no QT measurement can be calculated. Then the cause of failed QT measurement is shown at the bottom of the QT numerics area and the message “Cannot Analyze QT” is shown in the technical alarm area. Select the left or right arrow to switch leads.
8.9.6.3 2. Select the QT tab→ select the Setup tab. 3. Set QT Leads. All is selected by default. This means all leads are used for QT calculation. Changing the QTc Formula The monitor uses the Hodges correction formula by default to correct the QT interval for heart rate. To select the QTc formula, follow this procedure: 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. Set QTc Formula.
8.12 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 menu select Calibrate. Defibrillation Synchronization Pulse Output The monitor provides an multifunctional connector to output defibrillation synchronization pulse.
Problem Corrective Actions Excessive alarms: heart rate, lead fault 1. Check that electrodes are not dry. Perform skin preparation again and re-place the electrodes. For more information, see 8.4.1 Preparing the Patient Skin and 8.4.2 Applying Electrodes. 2. Check for excessive patient movement or muscle tremor. Reposition the electrodes. Replace with fresh and moist electrodes if necessary. Low Amplitude ECG Signal 1. Check that the ECG gain is not set too low. Adjust the gain as required.
9 Resting 12-Lead ECG Analysis 9.1 Resting 12-Lead ECG Analysis Introduction The monitor can be configured with either Glasgow 12-lead ECG analysis algorithm or Mindray 12-lead ECG analysis algorithm. The Glasgow algorithm is intended for adult, pediatric, and neonatal patients. The Mindray algorithm is intended for adult patients only. The monitor providing the 12-lead ECG analysis function has a 12-lead label. The monitor incorporating the Glasgow algorithm is labelled with the logo of Glasgow.
9.4.2 Setting the Baseline Drift Removal The baseline drift removal (BDR) 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 menu. 2. Select the Setup tab. 3. Switch on or off Baseline Drift Removal. If BDR is switched off, the 0.05 Hz high pass filter is used. NOTE • 9.4.
9.5.2 Setting Tachycardia and Bradycardia Thresholds (For Glasgow Algorithms) To set tachycardia and bradycardia thresholds, follow this procedure: 1. On the ECG 12-Lead screen, select Setup to enter the 12-Lead Setup menu. 2. Select the Setup tab. 3. Set Tachy and Brady. NOTE • • 9.5.3 The tachycardia threshold only applies to patients whose age exceeds 180 days. The bradycardia threshold only applies to patients whose age exceeds 2191 days.
10 Monitoring 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. Respiration rate (RR) is calculated from these impedance changes, and a respiration waveform appears on the patient monitor screen. Respiration monitoring is intended for adult, pediatric and neonatal patients. 10.
10.3 Resp Display (1) (2) (3) (1) Resp waveform gain (2) Resp lead label (4) Respiration rate (RR) (5) RR source (4) (5) (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 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.
10.4.2 Placing the Electrodes As the Respiration measurement adopts the standard ECG electrode placement, you can use different ECG cables. Since the respiration signal is measured between two ECG electrodes, if a standard ECG electrode placement is applied, the two electrodes should be RA and LA of ECG Lead I, or RA and LL of ECG Lead II. For more information, see 8.4.4 ECG Electrode Placements.
10.5 Changing Resp Settings 10.5.1 Setting the Resp Alarm Properties To set the Resp alarm properties, follow this procedure: 10.5.2 1. Select the Resp numeric area or waveform area to enter the Resp menu. 2. Select the Alarm tab. 3. Enter the password if required. For more information, refer to 6.9.3 Selecting Password for User Authentication. 4. Set alarm properties as desired. Setting the RR Source To set RR source, follow this procedure: 1.
10.5.6 Setting the Auto Detection Switch To set the auto detection switch, follow this procedure: 1. Select the Resp numeric area or waveform area to enter the Resp menu. 2. Select the Setup tab. 3. Switch on or off Auto Threshold Detection. ◆ If Auto Threshold Detection is switched on, the monitor automatically adjusts the Resp waveform detection level, or threshold. ◆ If Auto Threshold Detection is switched off, you have to manually adjusts the Resp waveform threshold.
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 haemoglobin 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 ◆ Electrosurgery equipment ◆ 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) (1) (2) (3) (4) (1) Pleth waveform (Pleth): visual indication of patient’s pulse.
• • • At elevated ambient temperatures be careful with measurement sites that are not well perfused, because this can cause burns after prolonged application. Avoid placing the sensor on extremities with an arterial catheter, an NBP 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.
fluctuation, the monitor integrates the number of SpO2 points, both positive and negative, until either the SatSeconds limit is reached, or the patient SpO2 re-enters the non-alarm range and remains there. NOTE • 11.6.3 The SpO2 Too Low or SpO2 Too High alarm is presented in the case that SpO2 value violates the alarm limits for 3 times within one minute even if the setting of Sat-Seconds is not reached. Setting the Nellcor SpO2 Sat-Seconds To set the Sat-Seconds, follow this procedure: 11.6.4 1.
11.6.6 Displaying SIQ (for Masimo SpO2) The signal quality indicator (SIQ) displays below the Pleth waveform. The SIQ is conveyed by vertical bars. The height of the bar provides an assessment of the confidence in the displayed SpO2 value. The SpO2 SIQ can also be used to identify the occurrence of a patient ‘s pulse. The following picture shows the SpO2 SIQ: (1) (1) Signal quality indicator (SIQ) To show SpO2 SIQ, follow this procedure: 11.6.7 1.
3. Set SpO2 Sensor Off. 11.6.11 Setting the SpO2 Tone Mode The monitor adjusts the QRS tone (pitch tone) according to the SpO2 values. To set the SpO2 tone mode, 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 SpO2 Tone. . CAUTION • The same SpO2 tone mode shall be used for the same monitors in a single area. 11.7 Changing the PR Settings 11.7.
11.8 SpO2 Troubleshooting This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting for services. If the problem persists, contact your service personnel. NOTE • 11.9 For the physiological and technical alarm messages, see D Alarm Messages. 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 menu.
11.9.1 Masimo Information ■ Masimo Patents This posting serves as notice under 35 U.S.C.§287(a) for Masimo patents: http://www.masimo.com/patents.htm. ■ No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
12 Monitoring Temperature (Temp) 12.1 Temperature Introduction You can continuously monitor the patient’s skin temperature and core temperature by the monitor. Thermally sensitive resistors (thermistors) are used. They are based on the principle that electrical resistance of the thermistor changes as temperature changes. Thermistors measure the resistance change and use it 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 menu. 2. Select the Alarm tab. 3. Enter the password if required. For more information, refer to 6.9.3 Selecting Password for User Authentication. 4. Set the alarm properties. Selecting the Temperature Label Select the temperature label according to the measurement site.
13 Monitoring Noninvasive Blood Pressure (NIBP) 13.1 NIBP Introduction The monitor uses the oscillometric method for measuring the 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.
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. It is essential to measure limb circumference and choose a cuff with proper size. NIBP Measurement Limitations Measurements are impossible with heart rate extremes of less than 30 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine.
(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 pressure NOTE • • If NIBP measurement fails, “XX” is displayed; if NIBP measurement is not taken, “--” is displayed.
4. Connect the cuff to the air tubing. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing. CAUTION • • • 13.7 A wrong cuff size and a folded or twisted bladder can cause inaccurate measurements. Do not touch or apply external pressure against the cuff and air tubing during NIBP measurement. This may cause inaccurate blood pressure values. Use care when placing the cuff on an extremity used for monitoring other patient parameters.
2. 13.8.3 Select Initial Pressure, and then select the appropriate setting. Setting the NIBP Interval For auto NIBP measurement, you need to set the interval between two NIBP measurements. To set the NIBP interval, follow this procedure: 13.8.4 1. Select the NIBP numeric area to enter the NIBP menu. 2. Set Interval. Selecting Manual switches to manual mode. Selecting NIBP Start Mode Start mode defines how NIBP auto mode works. To set the start mode, follow this procedure: 13.8.5 1.
◆ 2. 13.8.9 Select Main Menu quick key → from the Display column select Tile Layout. In the desired numeric area, select NIBP → NIBP List. Correcting the NIBP Measurements The middle of the cuff should be at the level of right atrium. If the limb is not at the heart level, you need to correct the measurement: 13.9 ■ Add 0.75 mmHg (0.10 kPa) to the displayed value for each centimetre higher. ■ Deduct 0.75 mmHg (0.10 kPa) to the displayed value for each centimeter lower.
14 Monitoring Invasive Blood Pressure (IBP) 14.1 IBP Introduction This patient monitor can monitor up to four invasive blood pressures. IBP monitoring is intended for adult, pediatric, and neonatal patients. PAWP monitoring is available only for the external display. PAWP monitoring is only intended for adult and pediatric patients. (2) (3) (1) (1) (1) (1) IBP cable connector (2) IBP dialog hard key (3) Zero IBP hard key WARNING • 14.
14.3 Preparing for IBP Monitoring 14.3.1 IBP Equipment to Patient Connection (1) (2) (3) (4) (5) (5) 14.3.2 (1) Pressure bag (2) N1 monitor (4) IBP transducer (5) Three-way valve (3) IBP cable Measuring an Invasive Blood Pressure To monitor IBP, follow this procedure: 1. Connect one end of the IBP cable to the IBP cable connector on the monitor, 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 or adapter cable is reconnected. ■ The monitor restarts. ■ You doubt the readings. ■ The monitor displays the prompt message Zero Required. To zero the transducer, follow this procedure: 1.
1. Disconnect the ICP adapter cable from the measurement module, or remove the module from the monitor. 2. Connect the ICP adapter cable, measurement module, and the target monitor, or insert the measurement module into the target monitor. 3. Check that the zero reference value displayed on the monitor is consistent with that recorded on the ICP transducer. ◆ Consistent: select Accept. ◆ Inconsistent: input the zero reference value recorded on the ICP transducer, and select Accept. CAUTION • 14.
3. Set IBP1 Label or IBP2 Label.
14.6.6 Setting the Use PA-D as PAWP Switch (only available for the independent external display) You can set whether PA-D value is used to replace PAWP value for hemodynamic calculation. To do so, follow this procedure: 1. Select the PA numeric area or waveform area to enter the PA menu. 2. Select the Setup tab. 3. Switch on or off Use PA-D as PAWP. For more information on hemodynamic calculation, see 18.4 Hemodynamic Calculations. 14.6.
Selecting the overlapped IBP waveforms on the main screen opens the Overlapping Waveform Setup menu, 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. ◆ Set PA Scale individually if the PA waveform is combined.
14.7.1 PAWP Equipment to Patient Connection (1) (2) (3) (4) (6) (7) (8) (5) 14.7.2 (1) N1 monitor (2) Flush bag (3) IBP transducer (4) Three-way valve (5) PA distal port (6) Balloon inflation valve (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 monitor. For more information, see 14.3.2 Measuring an Invasive Blood Pressure. 2.
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. If the PA waveform is stable yet the monitor still not show the prompt message Ready For Balloon Deflation, select the Freeze to freeze the waveform, and deflate the balloon. 6. Select Accept to save the PAWP value. 7.
14.7.5 Performing Hemodynamic Calculation (only available for the independent external display) On the PAWP screen, select Hemo Calcs to enter the Hemo Calcs menu. For more information, see 18.4 Hemodynamic Calculations. 14.8 IBP Troubleshooting This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting for services. If the problem persists, contact your service personnel.
15 Monitoring Carbon Dioxide (CO ) 15.1 CO2 Introduction 2 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.
(7) (1) CO2 menu hard key (2) CO2 Measure/standby hard key (3) CO2 watertrap seat (4) Gas outlet (5) Sample line connector (6) CO2 sensor connector (7) CO2 adapter connector 15.2 CO2 Safety Information WARNING • Route all tubing away from the patient’s throat to avoid strangulation. CAUTION • • • Remove the airway sample line from the patient’s airway while nebulized medications are being delivered. EtCO2 values measured from the CO2 module may differ from those of from the blood gas analysis.
15.4 CO2 Display The CO2 numeric and waveform area provide FiCO2 measurement, EtCO2 measurement, awRR measurement, and a CO2 waveform. (4) (1) (2) (1) CO2 waveform (2) End tidal CO2 value (EtCO2) (3) Airway respiration rate (awRR) (4) Fraction of inspired CO2 (FiCO2) (3) If your sidestream CO2 module is configured with the oxygen sensor, O2 waveform and parameters can be displayed as follows: (3) (2) (1) (1) O2 waveform (2) FiO2 measurement (3)EtO2 measurement 15.
(1) (2) (3) (1) Watertrap receptacle (2) DRYLINE II watertrap (3) Gas sample line ◆ If you’re using the N1 monitor for CO2 measure, connect the one end of the gas sample line to the CO2 adapter. Refer to the CO2 Adapter User Manual (PN: H-046-009994-00) for the connection of the CO2 adapter and the gas sampling line. (1) (2) (1) CO2 adapter 3. (2) Gas sample line Connect the other end of the gas sample line to the patient.
4. 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 is complete. WARNING • • Do not apply adult or pediatric watertrap to the neonate patient. Otherwise, patient injury could result. Connect the gas outlet to the scavenging system when measuring CO2 using the sidestream 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. ◆ For non-intubated patient, place the nasal cannula onto the patient. ◆ For patient prone to mouth breathing, place the oral-nasal cannula onto the patient. Connect the gas outlet to the a scavenging system using an exhaust tube.
(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 15.6.2Zeroing the Mainstream CO2 sensor. 4. After the zero calibration is finished, connect the airway as shown below. (5) (4) (4) Connect to patient 5. (5) Connect to ventilator Make sure that no leakages are in the airway and then start a measurement. NOTE • • • 15.6.
3. Set the Operating Mode to Measure. The message CO2 Sensor Warmup is displayed. 4. After warm-up is finished, connect the sensor to a clean, dry airway adapter. The adapter should be vented to the air and isolated from CO2 sources, such as ventilator, the patient’s breathing, your own breathing, etc. 5. Select Zero in the CO2 menu. The message Zeroing is displayed. It takes about 15 to 20 seconds. The message disappears when the zero calibration is completed.
■ Select Standby mode when you does not use the CO2 module to prolong the serviec life of the CO2 module. The default operating mode is Measure. If you are not using the CO2 module, you can proceed as follows to enter the Standby mode: 15.7.6 1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select the Setup tab. 3. Set Operating Mode to Standby.
1. Select the Main Menu quick key → from the System column select Maintenance → input the required . password → select 2. Select the Module tab → Other tab. 3. Set CO2 Flow Rate For Neo. 15.9 Changing O2 Settings (For Sidestream CO2 Module Integrating O2) 15.9.1 Changing O2 Alarm Settings To change the O2 alarm settings, follow this procedure: 15.9.2 1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select the Alarm tab. 3. Set alarm properties as desired.
■ ■ 15.11 ◆ Select Room Air when air predominates in the ventilation gas mixture. ◆ Select N2O when N2O predominates in the ventilation gas mixture. ◆ Select He when He predominates in the ventilation gas mixture. O2 Compensation ◆ Select Off when the amount of O2 is less than 30%. ◆ Select an appropriate setting according to the amount of O2 in the ventilation gas mixture. AG Compensation: enters the concentration of anesthetic gas present in the ventilation gas mixture.
4. Select the Main Menu quick key → from the System column select Maintenance → input the required . password → select 5. Select the Module tab → CO2 tab. 6. Check that the current flow rate is less than 10ml/min, and the alarm message “CO2 Airway Occluded” does not disappear. 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.
15.16.2 Troubleshooting the Mainstream CO2 Module 15.17 Problem Solution Elevated baseline 1. Check the patient status. 2. Check the sensor. Oridion Information This trademark is registered in Israel, Japan, German and America. Oridion Patents The capnography component of this product is covered by one or more of the following US patents: 6,428,483; 6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending.
16 Review 16.1 Review Overview Trends are patient data collected over time and displayed in graphic, tabular, or other forms to give you a picture of how your patient's condition is developing. You can review the trend data in the review page, minitrends window, or OxyCRG window (minitrends window and OxyCRG window are only available for the independent external display). You can also review the events, 12-lead ECG analysis results and waveforms, full disclosure waveforms, and so on. 16.
(4) Time line: indicates the entire time length. ■ : indicates the time length of reviewable trend data. time length. : indicates the time length of no trend data. ■ can be moved within this cannot be moved within this time length. Different color blocks at the time line indicate events of different types. See the color definition for the event type indicator. 16.2.3 (5) Event area: displays the event of the cursor time. Selecting the event access the event list.
16.2.5 ■ ***: high priority alarm ■ **: medium priority alarm ■ *: low priority alarm Reviewing the Tabular Trends The tabular trends review page displays trend data in a tabular form. To enter the tabular trends review page, select the Main Menu quick key → from the Review column select Tabular Trends. 16.2.5.1 Changing the Trend Group To change the trend group, follow this procedure: 16.2.5.2 1. Enter the tabular trends review page. 2. Set Trend Group.
16.2.6.1 Changing the Trend Group To change the trend group, follow this procedure: 16.2.6.2 1. Enter the Graphic trends review page. 2. Select and set Trend Group. Editing the Trend Group The setting of the Trend Group defines the contents of displayed and printed trends. You can edit the trend group. To do so, follow this procedure: 1. Enter the Graphic trends review page. 2. Select and select Group Setup. NOTE • • 16.2.6.3 You cannot edit the trend groups labeled All or Standard.
• 16.2.7.1 Earlier events will be overwritten by later ones if the capacity is reached. Entering the Events Review Page To enter the events review page, select the Main Menu quick key → from the Review column select Events. The Event page displays event list. Events are displayed in descending chronological order. The most recent event is displayed at the top.The number of asterisk symbols before an event indicate alarm priorities.
2. Select 3. Select the desired options. 4. 16.2.8 at the upper left corner of the review page. ◆ 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.
16.2.9 2. Select and set the time range for printing. 3. Select Print. OxyCRG Review Page (available for the independent external display) You can review up to 48 hours of trend curves on the OxyCRG review page. The OxyCRG review functionality is available for neonatal monitoring only. NOTE • 16.2.9.1 OxyCRG Review Page is available only when Patient Category is set to Neo. Entering the OxyCRG Review Page Choose one of the following methods to enter the OxyCRG review page: 16.2.9.
NOTE • 16.2.9.4 If the Zoom is set for a large duration (for example, 8 hrs), the screen may show "No Patient Data" for the first several minutes of data collection (for example, 6 minutes), but data will be shown after enough data has been collected. Printing an OxyCRG Review Report To print an OxyCRG review report, follow this procedure: 1. Enter the OxyCRG review page. 2. Select 3. Select Print. The report duration corresponds to the duration of data shown on the screen.
■ Select the Minitrends quick key. ■ Select the Screen Setup quick key → select Minitrends. ■ Select the Main Menu quick key → from the Display column select Choose Screen → select Minitrends. For adult and pediatric patients, when the Minitrends screen is hidden as following methods to quickly enter the Minitrends screen. , you can also choose one of the ■ Swipe left or right across the touchscreen with two fingers until you switch to the Minitrends screen.
17 Clinical Assistive Applications (only available for the independent external display) 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. 17.
(8) (7) (1) (6) (2) (3) (5) (4) 17.1.2 (1) EWS label (2) Total score. The color of the circle indicates the level of risk. (3) Single parameter whose score reaches 3 (4) Latest history total score (5) Risk level indicator. The level of risk increases from top down. (6) Scoring interval (7) The scoring time (8) Scoring countdown: time to the next scoring.
Z (12) (11) (10) (9) (1) (8) (2) (7) (6) (3) (4) (5) 17.1.3 (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.
3. Measure or manually enter other required parameters and observations. 4. If enabled, select the clinician ID 5. Select Calculate to get the total score. 6. If Score Confirmation is enabled, select Confirm to save current scoring, or select Cancel to give up current scoring. Refer to section 17.1.4.2 Setting the Scoring Confirmation Switch for more information. .
◆ 17.1.4.5 17.1.4.6 If no option is selected, the monitor does not initiate auto scoring. 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.
(4) (1) (5) (2) (6) (3) 17.2.2 (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 Accessing the GCS Menu Enter the GCS menu in any of the following ways: ■ Select the GCS parameter area ■ Select the GCS quick key.
17.2.4 Level Range Color Mild damage 12 to15 White Moderate damage 5 to 11 Yellow Severe damage 3 to 4 Red Setting GCS Scoring Interval From the GCS menu, select Interval to set GCS scoring interval. When the scoring interval is reached and you do not perform another scoring, the score will be invalid and displayed as outline fonts. 17.2.5 Setting Threshold and Color for Each Consciousness Level You can configure the threshold and color of each consciousness level.
• • 17.3.1 Due to space limitations on the screen, the recommendations cannot always be reproduced in the full detail available in the printed and on-line guidelines. SepsisSight is intended for patients suffering from sepsis or suspicion of sepsis. Accessing the SepsisSight Dialog Enter the SepsisSight dialog in any of the following ways: 17.3.2 ■ Select the SepsisSight quick key. ■ Select the Main Menu quick key → from the CAA column select SepsisSight.
17.3.3.2 Marking Implemented Items Check off implemented items. Then the time and date are automatically recorded and displayed. 17.3.4 ■ You can select the symbol to change the date and time. ■ Select Reset to clear the current results. Reviewing SepsisSight Trend Data Select the Graphic Trends tab to view the trend of parameters of resuscitation. When a recommended treatment is checked off on the Part I page and Part II page, relevant event is marked in the tabular trend.
17.4.2.1 Accessing the CPR Dashboard If you are entering the rescue mode for the first time, the CPR Dashboard opens automatically. If you have closed the CPR Dashboard, to open it, select the Main Menu quick key → from the CAA column select CPR Dashboard. 17.4.2.2 Recording the Rescue Process To record the rescue process using the CPR Dashboard, do as follows: 17.4.2.3 ■ To record the rescue start time: select Start Rescue.
18 Calculation (only available for the independent external display) 18.1 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 feature is independent of other monitoring functions and can be therefore used for patients being monitored by other monitors. Any operation in a calculation window does not affect the patient monitored by the current monitor.
18.3.2 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.
18.4 Hemodynamic Calculations The monitor provides the hemodynamic calculation function. The monitor can save the results of up to 10 calculations, which are displayed in groups. 18.4.1 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 systemic vascular resistance index SVRI DS•m2/cm5 SVRI (DS•m2/cm5) = SVR (DS/cm5) × BSA (m2) 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.
18.5.2 18.5.3 Input Parameters for Oxygenation Calculations Input Parameter Label Unit cardiac output C.O.
18.6 Ventilation Calculations The monitor provides the ventilation calculation function. The monitor can save the results of up to 10 calculations, which are displayed in groups. 18.6.1 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.
18.7 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. The monitor can save the results of up to 10 calculations, which are displayed in groups. 18.7.
Calculated Parameters Label Unit Formula urine potassium excretion URKEx mmol/24 hrs URKEx (mmol/24 hrs) = Urine (ml/24 hrs) × URK (mmol/L)/1000 sodium potassium ratio Na/K % Na/K (%) = 100 × URNa (mmol/L)/URK (mmol/ L) clearance of sodium CNa ml/24 hrs CNa (ml/24 hrs) = URNa (mmol/L) × Urine (ml/ 24 hrs)/SerNa (mmol/L) creatinine clearance rate Clcr ml/min Clcr (ml/min) = Ucr (μmol/L) × Urine (ml/24 hrs)/[Cr (μmol/L) × (BSA (m2)/1.
19 Printing 19.1 Printer The monitor can output patient reports via a connected network printer. So far, the monitor supports the following printer: ■ HP LaserJet Pro M202dw ■ HP LaserJet Enterprise M605 ■ HP LaserJet P4015n ■ HP LaserJet Pro 400 M401n ■ HP LaserJet 600 M602 NOTE • 19.2 For more details about the printer, see the document accompanying the printer. With product upgrades, the monitor may support more printers and no prior notice will be given.
19.3.2 Setting Patient Information on Other Reports To set the patient information you want to display on other reports, follow this procedure: 1. Select the Main Menu quick key → from the System column select Maintenance → input the required password → select 19.4 . 2. Select the Print tab. 3. Select the Report Layout tab. 4. Select the desired items under Report Name. N/A indicates that this item is not displayed on a report.
◆ 2. 19.7 Select the Main Menu quick key → from the Parameters column select Setup→ select the desired parameter → select the Alarm tab. Switch on On/Off and Alarm outputs for desired parameters. Stopping a Printing Task To stop a printing task, follow this procedure: 19.8 1. Select the Main Menu quick key → from the Report column select Print Queue. 2. Select desired printing tasks and then select Delete. Selecting Delete All to stop all the printing tasks.
19.8.2 Setting Realtime Reports To set tabular realtime reports, follow this procedure: 1. Select the Main Menu quick key → from the Report column select Normal Report. 1. Select Realtime Report. 2. Set the desired options. The following table only list some of the options. Menu item Function Description Select Waveform Select the desired waveform to print waveforms.
19.10 1. Select the Main Menu quick key → from the Report column select Print Queue. 2. View the status of printing tasks in the Print Queue window. Each printing task includes a report title, printing time and the printing status. The printing statuses are printing, failed, retrying, and waiting. Printer Out of Paper When the printer runs out of paper, the print request will not be responded. If there are too many print jobs that are not responded, a printer error may occur.
20 Battery 20.1 Battery Introduction This monitor is designed to run on rechargeable Lithium-ion battery power when the external power is not available. The monitor can switch between battery power and the external power without interrupting patient monitoring. If both the external power and the battery power are available, the monitor uses the external power in preference to the battery power. 20.2 Battery Safety Information WARNING • • • • • • • • • • Keep the battery out of children’s reach.
20.4 Battery Indications The battery LED, on-screen battery symbol, battery power indicator, and related alarm messages indicate the battery status. 20.4.1 Battery LED The battery LED lies on the lower right corner of the monitor front panel. BeneVision N1 Battery LED The battery LED indications are as follows: 20.4.2 ■ Yellow: the battery is being charged. ■ Green: the battery is fully charged. ■ Flashing green: the monitor runs on battery power.
If the battery is almost depleted, the monitor presents the Critically Low Battery alarm. In this case, immediately connect the external the monitor and charge the battery. Otherwise, the monitor will automatically shut down soon. If the battery has been used for a prolonged period of time, the battery will be aged and its runtime may be significantly less than the specification.
See steps 1 to 5 of 20.6.1 Conditioning the Battery to check battery performance. The operating time of the battery reflects their performance directly. If the operating time of a battery is noticeably shorter than that stated in the specifications, the battery may reach its service life or malfunction.If the battery performance meets the requirement, fully charge the battery again for use or charge it to 40 – 60% for storage. NOTE • 20.
21 Care and Cleaning 21.1 Care and Cleaning Introduction In this chapter we describe how to clean and disinfect the equipment. 21.2 Care and Cleaning Safety Information WARNING • • • • • Use only Mindray approved cleaners and disinfectants and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by unapproved substances or methods. We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection.
Product Name Product Type Ingredients Rely+OnTM Virkon® Powder Used as 1% solution* Biocidal active: Pentapotassium bis (peroxymonosulphate) bis (sulphate) (500g/kg) Contains dipotassium peroxodisulphate. 1-Propanol Liquid 1-Propanol 50% Dismozon® plus Powder Used as 0.
21.7 Cleaning, Disinfecting and Sterilizing Monitoring Accessories To clean, disinfect and sterilize reusable transducers, sensors, cables, leadwires, and so forth, refer to the instructions delivered with the accessory. If no instructions are delivered with the accessory, the instructions given in this chapter for cleaning, disinfecting and sterilizing the monitor are applicable. 21.
22 Maintenance 22.1 Maintenance Introduction Regular maintenance is essential to ensure that the equipment functions properly. This chapter contains information on periodic testing and maintenance. 22.2 Maintenance Safety Information WARNING • • • • • • • To avoid electric shock, stop using N1 if you find the housing of N1 has signs of broken. Contact the service personnel for help in that case.
22.3 Maintenance and Testing Schedule Follow the maintenance and testing schedule or local regulations to perform testing and maintenance. Make sure to clean and disinfect the equipment before taking any tests 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. Measurement module performance test and calibration 1.
22.5.1 Performing Visual Inspection Visually inspect the equipment before its first used 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: 22.5.2 ■ Environment and power supply specifications are met. ■ The monitor housing and display screen are free from cracks or other damages ■ The power cord is not damaged and the insulation is in good condition.
23 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.
23.1.3 23.1.4 23 - 2 Model Part No. Description Usage Applicable patient EV6211 0010-30-42723 12Pin 3/5-Lead ECG trunk cable, ESU-proof Reusable Adult/Pediatric EV6212 0010-30-42724 12Pin 3-Lead ECG trunk cable, ESUproof Reusable Pediatric/Neonate EV6222 040-000754-00 12Pin 3-Lead trunk cable, defibrillation-proof, DIN Conn Reusable Pediatric/Neonate EV6206 009-005266-00 ECG Cable, 10'(3.1 m), Def-P, for N/T Reusable Adult, pediatric EV6207 009-005267-00 ECG Cable, 20'(6.
23.1.5 23.1.6 23.2 Model Part No. Description Usage Applicable patient EY6507B 009-004790-00 5-Lead, New Telemetry, AHA, snap, 24’’ Disposable Adult/Pediatric 6-lead ECG Leadwires Model Part No.
23.2.2 23.2.3 23 - 4 Mindray SpO2 Sensors Model Part No.
23.2.4 Model Part No.
Model Part No. Description Usage Applicable patient / 0206-03-0118-02 PROBE，D TEMP，ES400-18 (box of 20) Disposable Adult / 0206-03-0209-02 PROBE，D TEMP，ER400-9 (box of 20) Disposable Adult / 0206-03-0212-02 PROBE，D TEMP，ER400-12 (box of 20) Disposable Adult / 0206-03-0300-02 PROBE，D TEMP，STS-400 (box of 20) Disposable Adult 23.4 NIBP Accessories 23.4.1 NIBP Hoses 23.4.2 23 - 6 Model Part No.
Model Part No. Description Usage Applicable patient CM1500B 001B-30-70678 Cuff, 4.3-8.0 cm Disposable Neonate CM1500C 001B-30-70679 Cuff, 5.8-10.9 cm Disposable Neonate CM1500D 001B-30-70680 Cuff, 7.1-13.1 cm Disposable Neonate CM1500E 001B-30-70681 Cuff, 5# Disposable Neonate 23.5 IBP Accessories 23.5.1 IBP Accessories 23.5.2 Model Part No.
23.6.2 23 - 8 Model Part No. Description Usage Applicable patient 60-15300-00 9200-10-10555 Sampling line, 2.
23.6.3 Model Part No.
A Product Specifications A.1 Monitor Safety Specifications The monitor is classified, according to IEC 60601-1: Degree of protection against electrical shock Type CF defibrillation proof for ECG, TEMP, IBP, SpO2,and NIBP Type of protection against electrical shock Class I Ingress Protection N1 monitor: IP44 (protected against ingress of foreign objects no less than 1.
A.3 Environmental Specifications WARNING • • • The monitor may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges. If the performance of the equipment is degraded due to aging or environmental conditions, contact your service personnel. When the monitor and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products.
Transient operating conditions The monitor is operated in normal use for a period not less than 20 minutes when moved from room temperature (20°C ± 2°C) to an environment of a temperature range from - 20 °C to 50 °C, and relative humidity range from 15% to 95% (non-condensing). The monitor is operated in normal use for a period not less than 20 minutes when moved from storage temperature (range from - 30 °C to 70 °C) to room temperature (20°C ± 2°C), and started up within 10 minutes after the movement. A.
Charge time For the monitor without internal CO2 module: no more than 6 hours to 90% when the monitor is off. no more than 10 hours to 90% when the monitor is on. For the monitor with internal CO2 module: no more than 3 hours to 90% when the monitor is off. no more than 5 hours to 90% when the monitor is on. A.5 Display Specifications N1 main unit Screen type Color TFT LCD Screen Size (diagonal) 5.5 inches Resolution 1280 x 720 pixels Pixel per inch (PPI) 269 External display A.
A.7.4 AC Adapter Power-on LED A.8 1 (green) Audio Indicator Speaker 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. A.9 Monitor Interface Specifications A.9.1 Interface Specifications of the Main Unit A.9.
A.10 Signal Outputs Specifications ECG Analog Output Bandwidth Diagnostic mode: 0.05 to 150 Hz (-3dB; reference frequency: 10Hz) Monitor mode: 0.5 to 40 Hz Surgical mode: 1 to 20 Hz ST mode: 0.05 to 40 Hz Maximum QRS delay 25 ms (in diagnostic mode, and non-paced) Gain (reference frequency 10Hz) 1V/mV (±5%) Pace enhancement Signal amplitude: Voh≥2.
A.12 Out-Of-Hospital Transport - Standards Compliance ■ Shock Tests according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN60068-2-27 (peak acceleration up to 100g). ■ Random Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-264 (RMS acceleration 5g). ■ Sinusoidal Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 600682-6 (acceleration up to amplitude 2g).
A.13 Wi-Fi Specifications A.13.1 Wi-Fi Technical Specifications Protocol IEEE 802.11a/b/g/n Modulation mode DSSS and OFDM Operating frequency IEEE 802.11b/g/n (at 2.4G) IEEE 802.11a/n (at 5G) ETSI: 2.4 GHz to 2.483 GHz ETSI: 5.15 GHz to 5.35 GHz, 5.47 GHz to 5.725 GHz FCC: 2.4 GHz to 2.483 GHz FCC: 5.15 GHz to 5.35 GHz, 5.725 GHz to 5.85 GHz MIC: 2.4 GHz to 2.495GHz MIC: 5.15GHz to 5.35 GHz KC: 2.4 GHz to 2.483 GHz KC: 5.15 GHz to 5.35 GHz, 5.47 GHz to 5.725 GHz, 5.725 GHz to 5.
■ A.13.2.2 The distance between the interfering devices and the monitor is greater than 20 cm. A Wi-Fi interference (no greater than -85 dBm) in the same channel and a Wi-Fi interference (no greater than -50 dBm) in an adjacent-channel are presented synchronously. The interfering devices include, but are not limited to, 2.4 G wireless devices, cellular mobile networks, microwave ovens, interphones, cordless phones, and ESU equipment. The interfering devices do not include Wi-Fi devices.
Input signal range ±8 mV (peak-to-peak value) Accuracy of signal reproduction Use A and D methods based on IEC 60601-2-25 2011 to determine frequency response. Electrode offset potential tolerance ±500 mV Lead-off detection current Measuring electrode: <0.1 μA Drive electrode: <1 μA Input offset current ≤0.
Response to irregular rhythm In compliance with the requirements in Clause 201.7.9.2.9.
HR High HR Low HR≤40bpm: (low limit + 2 bpm) to 40 bpm HR≤40bpm: 1 bpm HR > 40 bpm: (low limit + 5 bpm) to 295 bpm HR > 40 bpm: 5 bpm HR≤40bpm: 16 bpm to (HR high - 2 bpm) HR > 40 bpm: 40 bpm to (HR high - 5 bpm) ST High (low limit + 0.2 mV) to 2.0 mV (absolute) 0.05 mV 0 mV to 2.0 mV (relative) A.14.2 ST Low -2.0 mV to (high limit - 0.2 mV) (absolute)-2.
A.14.3 SpO2 Specifications Refer to F SpO2 Sensor Accuracy for the clinical study results of SpO2 sensor accuracy.
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.
PR from Nellcor SpO2 Module Measurement range 20 to 300 bpm Resolution 1 bpm Response time ≤30 s (normal perfusion, no disturbance, PR value sudden change from 25 to 250 bpm) Accuracy 20 to 250 bpm: ±3 bpm 251 to 300 bpm, not specified Refreshing rate ≤1 s PR from Masimo SpO2 Module Measurement range 25 to 240 bpm Resolution 1 bpm Response time ≤20 s (normal perfusion, no disturbance, PR value sudden change from 25 to 220 bpm) Accuracy ±3 bpm (without motion) ±5 bpm (with motion) Refreshin
A.14.5 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 ±0.2 °F (excluding probe error) Refreshing rate ≤1 s Minimum time for accurate measurement Body surface: <100 s Alarm limit Range Step T1/T2 High (low limit +1.0) to 50.0 °C 0.1 °C (low limit +2.0) to 122.0 °F 0.1 °F T1/T2 Low Body cavity: <80 s 0.1 to (high limit - 1.
Static pressure measurement range 0 mmHg to 300 mmHg Static pressure measurement accuracy ±3 mmHg Alarm limit Range (mmHg) Step (mmHg) NIBP-S High Adult: (low limit + 5) to 265 NIBP ≤ 50: 1 Pediatric: (low limit + 5) to 195 NIBP > 50: 5 Neonate: (low limit + 5) to 130 NIBP-S Low Adult: 41 to (high limit - 5) Pediatric: 41 to (high limit - 5) Neonate: 40 to (high limit - 5) NIBP-M High Adult: (low limit + 5) to 225 Pediatric: (low limit + 5) to 160 Neonate: (low limit + 5) to 105 NIBP-M Low
Accuracy ±2% or ±1 mmHg, whichever is greater (excluding sensor error) Refreshing rate ≤1s 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.
Sidestream CO2 Module Standard Meet the standard of ISO 80601-2-55 2011 CO2 Measurement range 0 to 150mmHg CO2 absolute accuracy* Full accuracy mode: 0≤CO2 concentration≤40 mmHg ± 2mmHg 41mmHg≤CO2 concentration<76 mmHg: ±5% of reading 77mmHg≤CO2 concentration<99 mmHg: ±10% of reading 100 mmHg≤CO2 concentration<150 mmHg: ±(3mmHg + 8% of reading) > 150 mmHg Unspecified Inaccuracy specifications are affected by the breath rate and I:E.
Response time For CO2 measurements (using external CO2 module without O2 sensor): Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line: ≤5.0 s @ 70 ml/min 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 2.5-meter adult sampling line: ≤5.0 s @ 120 ml/min For CO2 measurements (using external CO2 module with O2 sensor): Measured with a DRYLINE II neonatal watertrap and a 2.
Effect of interference gases on CO2 measurements Gas Concentration (%) Quantitative effect* N2O ≤60 ±1 mmHg Hal ≤4 Sev ≤5 Iso ≤5 Enf ≤5 Des ≤15 ±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 Concentration (%) CO2 0.2 N2O 0.2 HAL, DES, SEV, ISO, ENF 1.
CO2 Measurement range Accuracy A - 22 0 to 150 mmHg 0 to 40 mmHg: ±2 mmHg 41 to 70 mmHg: ±5% of the reading 71 to 100 mmHg: ±8% of the reading 101 to 150 mmHg: ±10% of the reading Accuracy drift Meet the requirement for measurement accuracy within 6 hours Resolution 1 mmHg 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 BeneVision N1 Patient Monitor Operator’s Manual
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 device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation. Use of this device adjacent to or stacked with other device should be avoided because it could result in improper operation.
• • • When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result. The EMISSIONS characteristics of this device make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this device might not offer adequate protection to radio-frequency communication services.
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.
Guidance and Declaration - Electromagnetic Immunity a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
Any changes or modifications to this equipment not expressly approved by Mindray may cause harmful radio frequency interference and void your authority to operate this equipment. The maximum antenna gain permitted complies with the e.i.r.p. limits as stated in RSS-210. The maximum antenna gain permitted complies with the e.i.r.p.
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 Arrhythmia Threshold Default Settings Default Setting Item C.1.3 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 PVC Window 15 beats 15 beats 15 beats PVCs/min 10 10 10 Pauses/min 8 8 8 Pause Threshold 2.0 sec 2.0 sec 2.
C.1.4 QT Default Settings Item QTc ∆QTc C.1.5 C.
Item Zero RR C.3 Default Setting Alarm switch On Priority High, unadjustable Alarm Outputs Off Zero RR 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 C.4 Temperature Default Settings C.4.1 Temperature Default Settings Item T1, T2 ∆T C.5 Default Setting Alarm switch On High limit 38.0 °C Low limit 35.0 °C Priority Med Alarm Outputs Off Alarm switch On High limit 2.
Item NIBP-D NIBP-M NIBP-S Extreme NIBP-D Extreme NIBP-M 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 Off High limit Adult: 175 mmHg Pediatric: 130 mm
C.
Item IBP-D Default Setting Alarm switch On High limit ■ Art/pArt/Ao/UAP/BAP/FAP/LV/P1-P4 arterial pressure Adult: 90 mmHg Pediatric: 70 mmHg Neonate: 60 mmHg ■ PA Adult: 16 mmHg Pediatric and neonate: 4 mmHg Low limit ■ Art/pArt/Ao/UAP/BAP/FAP/LV/P1-P4 arterial pressure Adult: 50 mmHg Pediatric: 40 mmHg Neonate: 20 mmHg ■ PA Adult: 0 mmHg Pediatric and neonate: -4 mmHg IBP-M Priority Med Alarm Outputs Off Alarm switch On High limit ■ Art/pArt/Ao/UAP/BAP/FAP/LV/P1-P4 arterial pressure
Item Art-S Extreme Art-D Extreme Art-M Extreme CPP Default Setting Alarm switch Off High limit Adult: 175 mmHg Pediatric: 130 mmHg Neonate: 95 mmHg Low limit Adult: 75 mmHg Pediatric: 60 mmHg Neonate: 50 mmHg Priority High Alarm Outputs Off Alarm switch Off High limit Adult: 105 mmHg Pediatric: 80 mmHg Neonate: 65 mmHg Low limit Adult: 35mmHg Pediatric: 30 mmHg Neonate: 15 mmHg Priority High Alarm Outputs Off Alarm switch Off High limit Adult: 125 mmHg Pediatric: 100 mmHg Neonat
Item Scale(mmHg) Default Setting CVP/pCVP/ICP/RAP/ LAP/UVP venous pressure 0-20 Art/pArt/Ao/BAP/FAP/ LV/P1/P2 arterial pressure 0-160 UAP/P3/P4 venous pressure 0-80 PA 0-30 PPV Measure Off PPV Source Auto PAWP Overlapping Waveform Setup Reference Waveform 1 II Reference Waveform 2 Resp Speed 12.5 mm/sec PA Scale(mmHg) 0-30 Left Scale(mmHg) 0-160 Right Scale(mmHg) 0-20 CVP Scale(mmHg) 0-20 ICP Scale(mmHg) 0-20 PA Scale(mmHg) 0-30 Speed 25 mm/sec Gridlines Off C.
C.7.2 Item Default Setting Speed 6.25 mm/s Scale 50 mmHg Waveform Type Draw Sidestream CO2 Default Settings Item EtO2 FiO2 C.7.3 C.7.
C.
D Alarm Messages D.1 Physiological Alarm Messages This section lists major physiological alarms, their default priority, and the actions that can be taken when an alarm occurs. Some of alarms may not be included. D.1.1 General Physiological Alarm Messages Alarm messages Default priority Cause and solution XX High High/Med, configurable XX Low High/Med, configurable XX value has risen above the high alarm limit or fallen below the low alarm limit.
Alarm message Default priority Pacer Not Capture Prompt 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.2 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 airway connection. Technical Alarm Messages This section lists major technical alarms, their default priority, indication on alarm reset, and the actions that can be taken when an alarm occurs. Some of alarms may not be included.
Alarm message Default priority Indication on alarm reset Cause and solution Cannot Analyze QT Prompt / / Note: XX represents ECG lead name, for example RL, LL, V, Va, Vb, and so on. D.2.3 D.2.4 D-4 Resp Technical Alarm Messages Alarm message Default priority Indication on alarm reset Resp Interference Prompt / The respiration circuit is disturbed. Check for any possible sources of signal noise. Electrode Poor Contact Prompt / Check the electrode application.
D.2.5 D.2.6 D.2.7 Temp Technical Alarm Messages Alarm message Default priority Indication on alarm reset T1/T2 Sensor Off Low A Cause and solution Check the sensor connection and reconnect the sensor. NIBP Technical Alarm Messages Alarm message Default priority Indication on alarm reset NIBP Cuff Loose Low A There is a leak in the cuff or air tubing. Use a cuff of correct type based on the patient size. Apply the cuff and connect the air tubing as instructed in the manual.
Alarm message Default priority Indication on alarm reset XX No Pulse Low A The catheter may be occluded. Please flush the catheter. XX Disconnected High C The liquid way is disconnected from the patient, or the three-way valve is open to the air. Check the connection of the liquid way, or check the valve is open to the patient. If the alarm persists, contact your service personnel. Cause and solution Note: XX represents an IBP label, for example PA, CVP, FAP, P1, and so on. D.2.
D.2.9 Alarm message Default priority Indication on alarm reset CO2 Low Barometric Low C The ambient pressure exceeds the operating pressure range or CO2 module fails. 1. Make sure that the ambient pressure meets the specifications, and check for sources that affect the ambient pressure. 2. Replug the module. If the alarm persists, contact your service personnel. 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.
Alarm message Default priority Indication on alarm reset XX V Too High High C XX V Too Low High C Cause and solution There is a problem with the system power supply. Restart the monitor. Note: XX represents 2.5 V, 3.3 V,5 V, or 12 V. D.2.10 D.2.11 Printer Technical Alarm Messages Alarm message Default priority Indication on alarm reset Printer Buffer Full Prompt / The printer buffer is full. Wait till the printer finishes the printing task.
Alarm message Default priority Indication on alarm reset 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. Read dock E2PROM error! High C 1. Check if you’re using the specified external display. • If you’re using the specified external display, remove the N1 from the Dock, and reconnect the N1 and the Dock.
E Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations. All tests can be performed using commercially available safety analyzer test equipment.
E.2.2 Contextual Inspection Test Item Acceptance Criteria The enclosure and accessories No unusual noises (e.g., a rattle inside the case). No unusual smells (e.g., burning or smoky smells, particularly from ventilation holes). No taped notes that may suggest device deficiencies or operator concerns. E.3 Device Labeling Check the labels provided by the manufacturer or the healthcare facilities are present and legible. E.
E.6 Patient Leakage Current Patient leakage currents are measured between a selected applied part and mains earth. All measurements have a true RMS only The following outlet conditions apply when performing the Patient Leakage Current test. ■ normal polarity (Normal Condition); ■ reverse polarity (Normal Condition), ■ normal polarity with open neutral (Single Fault Condition); ■ reverse polarity with open neutral (Single Fault Condition).
E.8 Patient Auxiliary Current Patient Auxiliary currents are measured between any selected Applied Part connector and the remaining Applied Part connector s. All measurements may have a true RMS only response. The following outlet conditions apply when performing the Patient Auxiliary Current test. ■ normal polarity (Normal Condition); ■ reverse polarity (Normal Condition), ■ normal polarity with open neutral (Single Fault Condition); ■ reverse polarity with open neutral (Single Fault Condition).
F SpO2 Sensor Accuracy F.1 The Accuracy of Mindray SpO2 Sensors Sensor Measurement range(%) Accuracy 520A 70~100 1.3188 90~100 1.2538 80~90 1.0394 70~80 1.7183 70~100 1.4844 90~100 1.1488 80~90 1.5224 70~80 1.7336 70~100 1.2520 90~100 1.0370 80~90 1.1660 70~80 1.5222 70~100 1.4023 90~100 1.3253 80~90 1.2187 70~80 1.7246 70~100 1.3518 90~100 1.2644 80~90 1.2367 70~80 1.5493 70~100 1.3644 90~100 1.0298 80~90 1.0584 70~80 1.8796 70~100 1.1510 90~100 1.
Sensor Measurement range(%) Accuracy 518B, 518C 70~100 1.8380 90~100 1.2487 80~90 1.6938 70~80 2.4207 90~100 1.4192 80~90 1.5238 70~80 2.
The Linear Matching Graph of 520P SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 520P SpO2 sensor and the reference equipment The Linear Matching Graph of 520N SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 520N SpO2 sensor and the reference equipment F-3
The Linear Matching Graph of 512H SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 512H SpO2 sensor and the reference equipment The Linear Matching Graph of 512E SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 512E SpO2 sensor and the reference equipment F-4
The Linear Matching Graph of 512F SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 512F SpO2 sensor and the reference equipment The Linear Matching Graph of 512G SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 512G SpO2 sensor and the reference equipment F-5
The Linear Matching Graph of 518B/518C SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 518B SpO2 sensor and the reference equipment The Linear Matching Graph of 512FLH SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 512FLH SpO2 sensor and the reference equipment F-6
F.2 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 F-8
F.3 The Accuracy of Nellcor SpO2 Sensors Sensor Motion # of Data Points ARMS (%) SpO2 Acceptance Criteria 70% - 100% (%) Pass/Fail MAX-A, MAX-P No 976 1.54 ≤2.0 Pass MAX-I, MAX-N No 723 1.41 ≤2.0 Pass DS-100A No 411 2.16 ≤3.0 Pass D-YS, OXI-P/I, OXI-A/N No 458 1.96 ≤3.5 Pass Modified Bland-Altman for SpO2 - MAX-A, MAX-P Sensors (No Motion): SaO2 vs. (SpO2 SaO2) 1. SpO2 - SaO2 (%) 2. SaO2 (%) 3. Upper 95% LoA 4. Mean Bias 5.
Modified Bland-Altman for SpO2 - MAX-I, MAX-N Sensors (No Motion): SaO2 vs. (SpO2 SaO2) 1. SpO2 - SaO2 (%) 2. SaO2 (%) 3. Upper 95% LoA 4. Mean Bias 5. Lower 95% LoA Modified Bland-Altman for SpO2 - DS-100A Sensor (No Motion): SaO2 vs. (SpO2 - SaO2) 1. SpO2 - SaO2 (%) F - 10 2. SaO2 (%) 3. Upper 95% LoA 4. Mean Bias 5.
Modified Bland-Altman for SpO2 - D-YS, OXI-A/N, OXI-P/I Sensors (No Motion): SaO2 vs. (SpO2 - SaO2) 1. SpO2 - SaO2 (%) 2. SaO2 (%) 3. Upper 95% LoA 4. Mean Bias 5.
G Units, Symbols and Abbreviations G.
G.
G.
Abbreviation In Full 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 Community EEG electroencephalogram EMC electromagnetic compatibility EMG electromyograph EMI electromagnetic interference Enf enflurane ESU electrosurgical unit Et end-tidal EtAA end-tidal anesthetic age
Abbreviation In Full 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 GEDV global end diastolic volume GEDI global end diastolic volume index GEF global ejection fraction Hal halothane Hb hemoglobin Hct haematocrit HIS hospital information system HR heart rate IBP invasive blood pres
G-6 Abbreviation In Full 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 MetHb methemoglobin MEWS Modified Early Warning Score MRI magnetic resonance imaging MV minute volume MValv Alveolar Minute Volume MVCO2 CO2 minute production MVe expiratory minute volume MVi inspiratory minute volume MVO2 O2 minute consumption N/A not applied N2 ni
Abbreviation In Full 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 RAP right atrial pressure Raw airway resistance Rec record, recording Res
G-8 Abbreviation In Full SVRI systemic vascular resistance index SVV stroke volume variation SvO2 venous oxygen saturation Sync synchronization Sys systolic pressure TB Blood Temperature TD temperature difference Temp temperature TFT thin-film technology TI injectate temperature TRC tube resistance compensation UAP umbilical arterial pressure UPS uninterruptible power supply USB universal serial bus UVP umbilical venous pressure VAC volts alternating current VEPT volume o
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.
