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N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor
Copyright
Shenzhen Comen Medical Instruments Co., Ltd.
Version: B00
Product Name: Multi-parameter Patient Monitor
Product Model: N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C
No.: 046-00000591-00
Revision Date: 06/2023
Service Life: 10 years
Software Version: V1.0
Company name: Shenzhen Comen Medical Instruments Co., Ltd.
Address: Floor 10, floor 11 and section C of floor 12 of building 1A & floor 1 to floor 5 of building 2, FIYTA Timepiece
Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, 518106, Guangdong, China.
Tel: +0086-755-26431236 Fax: +0086-755-26431232
Company name: Lotus NL B.V.
Address: Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands.
Tel: +31644168999
Statement
All rights reserved by Shenzhen Comen Medical Instruments Co., Ltd.
This manual contains confidential information. No part of this manual may be reproduced, copied or translated into
other languages in any form without written permission of Comen.
This manual is only intended for users as a reference for operation, maintenance and repair of Comen product
N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C. No one shall disclose the contents hereof to any other person.
Comen shall assume no liability for misuse of the information contained herein or any incidental or indirect damages
arising from improper operation or actual performance due to use of this manual. This Manual does not imply t he
transfer of any proprietary right under patent law to any third party. Comen shall not be liable for any legal
consequences arising out of breach of the patent law or infringement of any third-party rights.
Please note that while every effort has been made to ensure that the data provided in this document is accurate,
the information, figures, illustrations, tables, specifications, and schematics contained herein, are subject to change
without prior notice.
Warranty
Comen will be responsible for the safety, reliability and performance of the product within the warranty period, if
all of the following conditions are satisfied:
The product is used in accordance with this manual.
The product is installed, maintained or upgraded by approved or authorized pers onnel by Comen.
The storage and operating environments for the product shall comply with the recommended information and
product specifications contained in this manual.
Email: peter@lotusnl.com
I
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Table of Contents
Related Manuals for Comen N10
Summary of Contents for Comen N10
- Page 1 This Manual does not imply t he transfer of any proprietary right under patent law to any third party. Comen shall not be liable for any legal consequences arising out of breach of the patent law or infringement of any third-party rights.
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Page 2: After-Sales Service
The product will be repaired or replaced free of charge within the warranty period. After the warranty period, Comen will charge for the service and replacement parts. If the products need to be returned to Comen for s ervice, the freight charges (including the customs duty) should be on the customer’s account. - Page 3 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor Preface This manual provides details on the performance, operations, maintenance, storage and safety instructions of N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C Multi-parameter Patient Monitor (hereinafter referred to as the “monitor”). Intended Readers This manual is intended for trained professionals and personnel who are expected to have working knowledge of medical procedures, practices and terminology as required for monitoring patients.
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Page 5: Table Of Contents
N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor Contents Copyright....................................I Statement ..................................... I Warranty ....................................I Returns Process ................................... II After-Sales Service ................................II Preface ....................................III Intended Readers ................................III Illustrations..................................III Conventions ..................................III Blank Page ................................... IV Contents ....................................V Chapter 1 Safety ................................1-1... - Page 6 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 3.2.1 Connection of the AC power supply cord .....................3-2 3.2.2 Connect to DC Power Source (for N10/N10A/N10C) ...................3-2 3.2.3 Protective Grounding............................3-3 3.2.4 Equipotential Grounding ..........................3-3 3.3 Connection of Device Components ........................3-3 3.3.1 Connect the sensor ............................3-3 3.4 Startup and Shutdown ............................3-4...
- Page 7 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 4.4.1 Freeze Waveforms ............................4-9 4.4.2 View Frozen Waveforms ..........................4-9 4.4.3 Unfreeze ................................4-9 4.4.4 Print Frozen Waveforms..........................4-9 4.5 Use of Timers................................4-9 4.5.1 Timer Display ..............................4-10 4.5.2 Timer Operation ............................4-10 4.5.3 Timer Setup ..............................4-10 Chapter 5 Patient Management ...........................
- Page 8 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 7.4.4 Alarm Parameter Forms ..........................7-3 7.4.5 Alarm Status Icon ............................7-3 7.5 View Physiological Alarm conditions ........................7-4 7.6 View Technical Alarm conditions ..........................7-4 7.7 Set Alarm Limits ..............................7-4 7.7.1 Manual Adjust Alarm Limit..........................7-4 7.7.2 Set Auto Alarm Limits .............................7-4 7.8 Set Alarm Volume ..............................7-5...
- Page 9 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 7.18 Cardiopulmonary Bypass (CPB) Mode ......................7-13 7.18.1 Enter CPB Mode ............................7-13 7.18.2 Exit CPB Mode ............................7-13 7.19 Intubation Mode ............................... 7-14 7.19.1 Enter Intubation Mode ..........................7-14 7.19.2 Set Intubation Mode Time ........................7-14 7.19.3 Exit Intubation Mode ..........................
- Page 10 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 8.4.8.8 Set Heart Beat Marker.......................... 8-12 8.4.9 Set Smart Lead Off ............................8-12 8.4.10 Set Lead Off Alarm Priority........................8-12 8.5 Arrhythmia Analysis ............................8-12 8.5.1 Safety Information on Arrhythmia......................8-12 8.5.2 Arrhythmic Events............................8-13 8.5.2.1 Lethal Arrhythmia ..........................
- Page 11 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 8.8.3 Display QT/QTc Parameters and Waves..................... 8-27 8.8.4 QT View................................. 8-27 8.8.5 QT Setup ............................... 8-28 8.8.5.1 QT Alarm..............................8-28 8.8.5.2 QT Leads ..............................8-28 8.9 ECG Relearn ................................. 8-29 8.9.1 Start ECG Relearn Automatically ........................ 8-29 8.9.2 Start ECG Relearn Manually ........................
- Page 12 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 11.1 Overview................................11-1 11.1.1 Identification of SpO Type........................11-1 11.2 Safety Information ............................11-2 11.2.1 Masimo SpO2 Specific Information ......................11-5 11.3 Measurement Restrictions ..........................11-6 11.4 SpO Display ..............................11-6 11.5 Low Perfusion Accuracy Test..........................11-7 11.6 Monitoring Steps...............................
- Page 13 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 12.4 NIBP Display............................... 12-3 12.5 Display NIBP List ..............................12-4 12.6 NIBP Setup ................................. 12-4 12.6.1 Set Patient Type ............................12-4 12.6.2 Set NIBP Alarm ............................12-4 12.6.3 Set Initial Pressure ............................. 12-4 12.6.4 NIBP End Tone............................12-4 12.6.5 Set NIBP Measure Sequence ........................
- Page 14 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 14.3.2 Measurement Steps..........................14-5 14.3.3 Zero the Pressure Sensor .......................... 14-6 14.4 IBP Display ................................. 14-6 14.5 IBP Setup................................14-7 14.5.1 Set IBP Alarm .............................. 14-7 14.5.2 Set Auto Alarm Limits ..........................14-7 14.5.3 Change Pressure Label..........................14-7 14.5.4 Display Pressure Type ..........................
- Page 15 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 15.6 Zeroing the CO Sensor ............................. 15-9 15.6.1 Zeroing the Masimo CO Module......................15-9 15.6.2 Zeroing the Respironics & Comen Mainstream CO Module..............15-9 15.6.3 Zeroing the Respironics & Comen Sidestream CO Module ..............15-9 15.7 CO Setup.................................
- Page 16 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 16.5.4 Set Patient Information ..........................16-3 16.5.5 Set Interval ..............................16-3 16.5.6 Set C.O. Coefficient ............................ 16-4 16.5.7 Set Injection Temp ............................. 16-4 16.5.8 Set Inject Volume ............................16-4 16.5.9 Set Measure Mode ............................ 16-4 16.6 Cardiac Output Measurement .........................
- Page 17 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 17.8 12-Lead Report Review............................. 17-8 17.8.1 Go to the 12-Lead ECG Page ........................17-8 17.8.2 View the Average Template ........................17-8 17.8.3 Set the Waveform Displayed in 12-Lead ECG Page ................. 17-8 17.8.4 Print the 12-Lead ECG Report ........................17-8 17.9 ST ..................................
- Page 18 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 18.2.5 EWS Review ..............................18-6 18.3 Glasgow Coma Scale (GCS) ..........................18-6 18.3.1 Go to the GCS Screen..........................18-6 18.3.2 GCS Scoring..............................18-7 18.3.3 GCS Scoring Review ........................... 18-7 18.4 ECG 24H Summary ............................18-7 18.4.1 Go to the ECG 24H Summary Window .....................
- Page 19 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 19.7.2 Output Parameters ............................ 19-8 Chapter 20 Record ................................. 20-1 20.1 Description of Recorder............................ 20-1 20.2 Start Recording..............................20-1 20.2.1 Start Recording Manually .......................... 20-1 20.2.2 Start Recording Automatically ........................20-1 20.3 Stop Recording ..............................20-2 20.3.1 Stop Recording Manually ..........................
- Page 20 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor 23.1 Overview................................23-5 23.2 Cleaning of the Monitor, Plug-in Modules ...................... 23-6 23.3 Disinfection of the Monitor, Plug-in Modules ....................23-7 23.4 Cleaning and Disinfection of Accessories ......................23-7 23.4.1 Cleaning and Disinfection of NIBP Cuffs....................23-7 23.4.2 Cleaning and Disinfection of other accessories ..................
- Page 21 N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor Appendix IV Default configuration information..................IV-1 Appendix V EMC ..........................V-1 Appendix VI Glasgow 12-Lead ECG Analysis..................VI-11 VI.1 Wave measurement ............................VI-11 VI.2 ST Segment and Amplitude Measurement ..................... VI-12 VI.3 Interval Measurements ............................ VI-13 VI.4 Stability of Measurements against Noise ....................... VI-13...
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Page 22: Blank Page
N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15COperating Instructions for Patient Monitor Blank Page XXII... -
Page 23: Chapter 1 Safety
Chapter 1 Safety 1.1 Safety Information WARNING Information that alerts you to situations that may result in serious consequences or endangers personal safety. Failure to observe the warning information may cause severe injury or even death of the user or patient. - Page 24 The monitor software upgrade must be carried out by a service technician trained and authorized by Comen. If you need to upgrade the software via USB, please contact Comen. Follow the local laws and regulations or the waste disposal rules of the hospital when disposing of packaging materials.
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Page 25: Contraindications
Safety The operator must not touch any Signal Input/Signal Output connectors while simultaneously touching the patient. Do not connect electrode or sensor lead wires into electrical outlets. Lead wire contact with electrical outlets presents a serious shock hazard. ... -
Page 26: Symbols
Safety 1.3 Symbols Refer to instruction manual/ Note! Follow instructions for use Complies with Regulation (EU) European community representative 2017/745 Medical device Manufacturer Serial number Date of manufacture Type BF applied parts, with Type applied parts, with defibrillation-proof defibrillation-proof AC indicator Battery status indicator Standby Power on/off key... - Page 27 Safety Warning: Only use the cable provided by Comen. The defibrillation protection relied on accessories. This Side Up Stacking Layer Limit Fragile Keep dry Does not contain DEHP Latex free Do not re-use Use-by date Do not use if package is damaged...
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Page 28: Chapter 2 Overview
2.1.2 Intended Use of Product N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C (hereafter N series) patient monitor is a multi-parameter physiological patient monitor intended for use within a professional healthcare facility. The monitors support... - Page 29 Overview It supports the function of adult/pediatric/neonatal mode; N15A 15.6inches, wide screen Dark grey Cardio Pulmonary Bypass (CPB) mode/standby mode/privacy mode/night mode/intubation mode It supports the function of adult/pediatric/neonatal mode; N15C 15.6 inches, wide screen Dark grey Cardio Pulmonary Bypass (CPB) mode/standby mode/night mode/intubation mode/ optional privacy mode...
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Page 30: Monitor Appearance
Overview 2.2 Monitor Appearance 2.2.1 Front View (6) (5) (1) Alarm indicator (2) Display screen (3) Function keys : (Alarm reset) Press this key to reset current alarm. : (Alarm paused) Press this key to pause or resume an alarm. : (Graphical recorder) Press this key to start or stop recording. -
Page 31: Left View
Overview 2.2.2 Left View The ports shown in the figure below are located on the left side of the monitor: (1) Sensor connector 2.2.3 Right View (1) Recorder (2) Lock for battery compartment (3) Battery compartment... -
Page 32: Rear View (N10/N10A/N10C)
(3) AC power socket. (4) DC power socket (Only available for N10/N10A/N10C): It can be connected to the vehicle power source through a DC power cord for DC power supply. (5) Network port Available only when the monitor is using the Windows system for monitoring, networking to the central monitoring system (CMS) or other specified devices through a standard network cable. -
Page 33: Rear View (N12/N12A/N12C/N15/N15A/N15C)
Overview May be used as the synchronization defibrillation output port to output defibrillation synchronization signals. May be used as the analog output port to output analog signals. 2.2.5 Rear View (N12/N12A/N12C/N15/N15A/N15C) (1) Handle (2) AC power socket. (3) Equipotential conductor When another device is used together with the monitor, a wire should be used to connect the equipotential port of that device to that of the monitor, thus to eliminate the earth potential difference between different devices and ensure safety. -
Page 34: On-Screen Display (Osd)
Overview call signal will be activated to alert the nurse if an alarm is generated. May be used as the synchronization defibrillation output port to output defibrillation synchronization signals. May be used as the analog output port to output analog signals. 2.3 On-screen Display (OSD) The figure below shows a general interface: (10) -
Page 35: Interface Symbols
Overview (9). Waveform/Parameter Area: Displays parameter waveforms or parameter values, units, alarm limits, alarm states, etc.. The user can select a parameter area or waveform area to enter the corresponding parameter “Section 4.3.1 Enter the Parameter Setup Window” setup menu. See for details. -
Page 36: Menus
Quick keys refer to some graphic hot keys shown in the lower part of the screen, allowing you to quickly access some functions. Generally, 14 hot keys are displayed in the Hot Key Area (except N10/N10A/N10C displays 10 hot keys). The [Main Menu] button is always displayed at the lower right corner of the Hot Key Area, and the [More] button is always displayed at the lower left corner of the Hot Key Area. - Page 37 Overview Icon of Name of Icon of Name of Function Function Quick Key Quick Key Quick Key Quick Key Alarm Sound Pause the alarm Alarm Suspend the current Paused sound Paused alarm Alarm Audio Turn off the alarm Alarm Off Turn off the alarm sound Enter the [Review]...
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Page 38: Set Quick Keys Displayed On The Screen
Overview Icon of Name of Icon of Name of Function Function Quick Key Quick Key Quick Key Quick Key Enter the [EWS] Enter the [Discharge] Discharge screen dialog box Enter the ECG 24h SepsisGuide View ECG 24h Summary [SepsisGuide] menu Summary Enter the [CCHD] CCHD... -
Page 39: Chapter 3 Installation And Preparation
Check whether all accessories are provided according to the Packing List. Check for damage. Check all exposed lead wires and connectors. For any problem or inconsistencies, contact Comen or your distributor. Keep the packaging materials for future use. 3.1.2 Environmental Requirements The operating environment for this device must conform to the environmental requirements specified in this manual;... -
Page 40: Device Preparation
3.2.2 Connect to DC Power Source (for N10/N10A/N10C) When it is used in an ambulance, the monitor N10/N10A/N10C can be connected to the vehicle DC power source: The monitor is equipped with a DC power cord. Connect one end of the power cord to the DC power outlet on the vehicle. -
Page 41: Protective Grounding
Installation and Preparation Do not use the DC power cord with any damage. 3.2.3 Protective Grounding To protect both the patient and the operator, the housing of the monitor must be grounded. The monitor is equipped with a detachable 3-wire power cord which shall be inserted into a grounded power outlet to ensure that monitor is grounded. -
Page 42: Startup And Shutdown
Installation and Preparation 3.4 Startup and Shutdown 3.4.1 Startup Prior to startup, check to see if each component of the device has any mechanical damage. Check whether the device can start up normally. After the power switch is turned on, the device enters the self-test process. The indicator illuminates red, yellow, green for one second each, and then the company logo is displayed, and with a “beep”... - Page 43 Installation and Preparation NOTE In the case of unexpected power supply interruption, if the monitor is restarted within 30min, it will load patient information, monitoring data and configuration data from before the power failure. If the power is restored after 30min, it will load the default configuration set as normal startup/shutdown.
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Page 44: Chapter 4 Basic Operations
Chapter 4 Basic Operations 4.1 Operation and Browsing 4.1.1 Use of theTouch Screen The monitor is equipped with a touch screen allowing touch operations. If you don't want to use the touch function, or to prevent misoperation, you can lock the screen. Long press the hot key [Main Menu] and slide it in the direction of the arrow to temporarily lock the screen, and then the symbol “... -
Page 45: Use Of A Scanner
4.1.4.1 Clear Data Format If you use the QR code scanner customized by Comen, it is necessary to clear the previous data format and configure the scanner before initial use. Here are the steps for clearing data format: Scan the barcode or engineering QR code for format clearing to clear the old data format. -
Page 46: Privacy Mode
Basic Operations Select the [Main Menu] hot key → select [Night Mode] from the [Display] column. Change the default settings of Night Mode. Select [Enter Night Mode] to enter this mode. CAUTION Before entering Night Mode, please confirm the settings of Brightness, Alarm Volume and QRS Volume. Please pay attention to potential risks if the settings are too low. -
Page 47: Standby Mode
Basic Operations You can exit Privacy Mode: by selecting [Exit Privacy Mode] on the screen; or by disconnecting from the CMS; or when the battery level is too low. 4.2.4 Standby Mode If patient monitoring is not needed for the time being, but you don't want to shut down the devi ce, Standby Mode can be used. -
Page 48: General Settings
Basic Operations 4.3 General Settings 4.3.1 Enter Parameter Setup Window Each parameter shown on the screen can be set. The user can enter the Setup window in the following ways: Select the waveform area or parameter area corresponding to a parameter. ... -
Page 49: The Display Of The Spo Screen
Basic Operations 4.3.2.2 The display of the SpO screen The figure below shows an illustration of SpO screen, your monitor might show a slightly different view. 4.3.2.3 Operating the SpO screen You can access the parameter setup and trend review from the SpO sceen in the following way: ... -
Page 50: Set Layout Of The Large Fonts Screen
Basic Operations 4.3.4 Set Layout of the Large Fonts Screen You can select parameters and waveforms to be displayed and their positions in the large-font screen as shown below: Enter the [Large Fonts] tab in either of the following ways: ... -
Page 51: Set Units
Basic Operations When the brightness is set to [Auto], the monitor will automatically adjust the brightness according to the intensity of ambient light. 4.3.8 Set Units Select the [Main Menu] hot key → select [Maintenance] from the [System] column → input the maintenance password →... -
Page 52: Freeze Waveforms
Basic Operations 4.4.1 Freeze Waveforms You can select the [Freeze] hot key to freeze active waveforms. Parameter data is refreshed normally. In the frozen state, the following windows and waveforms are normally displayed and refreshed: Minitrends Screen OxyCRG ... -
Page 53: Timer Display
Basic Operations 4.5.1 Timer Display You can enter the [Tile Layout] screen in either of the following ways: Select the [Screen Setup] hot key → select the [Tile Layout] tab. Select the [Main Menu] hot key → select [Tile Layout] from the [Display] column. Select the position where the timer is to be displayed in the Parameter Area;... - Page 54 Basic Operations NOTE The user cannot set the timer while it is running. The settings of [Direction], [Run Time] and [Reminder Volume] are valid only when [Timer Type] is set to [Normal], [Advanced] or [Cycled]. 4-11...
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Page 55: Chapter 5 Patient Management
Chapter 5 Patient Management 5.1 Discharging a Patient The previous patient should be discharged before monitoring a new patient. After discharge, the monitor will enter the idle state. Depending on the circumstance, you can select [Monitor] (Quick Admit) or [Patient Management] (Normal Admit) to select how to admit a patient. -
Page 56: Quick Admit
Patient Management 5.2.1 Quick Admit When the user does not have enough time to get patient info, the Quick Admit mode can be used. Later, the user must complete the other info of the patient. Here are the steps: After patient discharge, select [Monitor] to quickly admit a patient. Section 5.3.2 Edit After admitting the patient please input the patient information as fast as possible. -
Page 57: Set Items Displayed In The Patient Management Menu
Patient Management 5.3.3 Set Items Displayed in the Patient Management Menu You can set whether or not to display and edit the patient's room No., middle name, race, age and other information in the following way: Select the [Main Menu] hot key → select [Maintenance] from the [System] column → input the maintenance password →... -
Page 58: Chapter 6 Manage Configurations
Chapter 6 Manage Configurations 6.1 Summary For continuous monitoring of a patient, the user/operator may be required to adjust some settings according to the actual patient conditions. The collection of pre-set items used to operate the monitor is called a configuration. In order to configure the monitor more effectively and rapidly, this monitor provides a variety of configurations to meet the requirements of different patient types and different hospital departments. -
Page 59: Set Default Patient Category
Manage Configuration NOTE The monitor will load the factory default settings when changing Department, admitting patient and changing patient type. 6.2 Set Default Patient Category You can set the patient type when admitting a patient as follows: Click [Main Menu] hot key → [Configuration] → [Manage], enter the configuration password and click the Enter key. -
Page 60: Save Current Settings
Manage Configuration default settings and user settings can be selected under each patient type. 6.5 Save Current Settings The Current configuration of the monitor can be saved as the user configuration under the current department. Up to 25 sets of user configurations can be saved for each department. Save Current Settings in the following way: Click [Main Menu] hot key →... -
Page 61: Load Configurations
Manage Configuration Enter key. Click [Import Configuration] button. Select the settings to be imported. Click [Import] 6.9 Load Configurations Click [Main Menu] hot key → [Configuration] → [Load]. Load the settings. The current settings on the monitor are displayed on the [Local] screen. ... -
Page 62: Chapter 7 Alarms
Chapter 7 Alarms The device continuously monitors the patient and its own performance to ensure that all of the systems are functioning as intended. When an abnormality or failure occurs, the device activates auditory and visual alarm signals to remind/warn the user. The monitor provides alarm signals in the real-time monitoring mode. -
Page 63: Alarm Types
Alarms The physiological waveforms, physiological parameters, alarms and other information displayed on the screen are only for reference by doctors, which shall not be used as a basis for clinical treatment. 7.2 Alarm Types Alarms generated by the monitor are classified into physiological and technical alarms. ... -
Page 64: Sound Alarm
Alarms Low-priority alarm: Cyan, no flashing, light constantly on 7.4.2 Sound Alarm Sound alarms refer to different priorities of alarms generated by the monitor with different sound characteristics. beep-beep-beep--beep-beep----beep-beep-beep--beep-beep （two sets of five High-priority alarm: short beep tones） Medium-priority alarm: beep-beep-beep（one set of three short beep tones）... -
Page 65: View Physiological Alarm Conditions
Alarms Alarm reset: indicates that alarms are acknowledged and the alarm system is reset. 7.5 View Physiological Alarm conditions View physiological alarms as follows: Select physiological alarm area to enter [Alarm] window. Select [Physiological Alarms] Tab. The current alarms are in the displayed list. Select [Details] to get more information. -
Page 66: Set Alarm Volume
Alarms Select [Limits] at the lower right corner of [Auto Limit] page. Select [OK] on the pop-up dialog window. You can also set the auto alarm limit for one parameter from the parameter menu. The monitor calculates auto alarm limits. The user has to confirm if these limits are appropriate for the patient. Outside this range, no auto limit is calculated, and should be manually adjusted, based on the clinician’s judgement about the specific patient. -
Page 67: Set Alarm Reminder
Alarms 7.8.3 Set Alarm Reminder When the alarm volume is set to 0, or the alarm is reset, or the alarm function is turned OFF, the monitor will provide a periodic alarm mute reminder to remind the user of the situation that there is still activated alarm in the current system. -
Page 68: Alarm Pause
Alarms key. Click [Alarm] tab → [Paused/Reset] tab. Set [Pause] to [Alarm Pause] or [Alarm Audio Pause]. The default value is [Alarm Pause]. 7.9.2 Alarm Pause If the alarm function is defined as [Alarm Pause], Click [Pause] hot key to pause the alarm. This function will: ... -
Page 69: Alarms All Off
Alarms 7.9.5 Alarms All Off Section 7.9.3 Set Alarm Pause Time If [Pause Time] is set to [Permanent] (refer to “ ”), the [Alarm Pause] hot key is changed to [Alarm off] key. All alarm signals will be shut down if [Alarm Pause] hot key is pressed, that is, alarms are off, and: ... -
Page 70: Alarm Audio Off
Alarms 7.9.9 Alarm Audio Off Section 7.9.3 Set alarm pause time If [Pause Time] is set to [Permanent] (refer to " "), the [Alarm Audio Paused] hot key is changed to [Alarm Audio off] key. All alarm audio will be muted if [Alarm Audio Paused] hot key is pressed. Alarm audio off characteristics: ... -
Page 71: Set The Switch Status Of Cms Alarm System Control
Alarms Select [Alarm] tab→[Other] tab Switch ON or OFF the [CMS Disconnection Alarm]: if OFF is selected, the alarm information [CMS Disconnected] will not be generated when the monitor is disconnected from the CMS. 7.13 Set the Switch Status of CMS Alarm System Control User can choose whether to allow the CMS monitoring system to control the Monitor’s alarm system by: Select [Menu] hotkey→[System]--- [Maintenance]→input password→click Enter key Select [Alarm] tab→[Other] tab... -
Page 72: Technical Alarm Reset
Alarms 7.15.2 Technical Alarm Reset When the technical alarm is reset, For fully clearable technical alarm conditions the alarm audio will be cancelled. The monitor will give no alarm indicaitons of the cleared technical alarms. Clearable alarm conditions will be changed to prompt messages. ... -
Page 73: Remote View Reset
If Nurse Call is active the monitor will send a request signal to the Nurse Call system for calling a nurse when the user set alarm is triggered. The monitor provides a Nurse Call interface. After the monitor is connected with the hospital Nurse Call system through the dedicated Nurse Call cable (available from Comen), the Nurse Call function can be enabled. -
Page 74: Cardiopulmonary Bypass (Cpb) Mode
Alarms Select [Alarm] tab → [Nurse Call] tab. Select [Alarm Priority] to set the priority of alarm that can trigger the Nurse Call function. Select [Alarm Category] to set the type of alarm that can trigger the Nurse Call function. WARNING ... -
Page 75: Intubation Mode
Alarms 7.19 Intubation Mode The monitor provides an intubation mode when monitoring the parameters of RESP, CO , AG and RM. Intubation mode is a unique monitoring mode. In this mode, the parameters of RESP, CO , AG and RM are all blocked, and the alarm off icon appears in the parameter area. -
Page 76: Restore Alarm Defaults
Alarms 7.21 Restore Alarm Defaults Click [Main Menu] hot key → [System] → [Maintenance], enter the maintenance password and click the Enter key. Select [Alarm] tab. Press the [Defaults] button. 7.22 Alarm System Self-test Upon startup of the device the alarm system will perform a self-test of the alarm light and alarm audio. Alarm lights and alarm sound characteristics during self-test are: ... -
Page 77: Chapter 8 Ecg Monitoring
Defibrillator protection requires use of defibrillation-proof ECG cables. Use only ECG cables and electrodes specified by Comen. During defibrillation, do not contact the patient, table or equipment. -
Page 78: Ecg Display
ECG Monitoring CAUTION The clinical operator should ensure that the summation of leakage currents does not exceed the safety limits when several items of the device are interconnected. Hazards may be caused by the operation of a cardiac pacemaker or other electrical stimulators with the patient monitor. -
Page 79: Monitor Setup
ECG Monitoring (1) Lead (2) Gain (3) Filter mode (4) Notch filter frequency (5) Pacer mode icon：Set [Pacer] as yes, the icon indicates. Set [Pacer] as no, no such icon display. (6) Parameter name (7) HR unit (8) HR numerical value (9) HR alarm limit (10) 1mVscale (11) Heart beat marker（N/A/P）... -
Page 80: Install Ecg Leads
ECG Monitoring 8.3.3 Install ECG Leads The table below lists the names of leads in European and American standards. (RA, LA, RL, LL and V are used to represent leads in AHA code, whereas R, L, N, F and C are used in the European code): American code European code Electrode identifier... -
Page 81: Place 5-Lead Electrodes
ECG Monitoring Lewis LA Black (U.S.A.) L Yellow (EU) RA White (U.S.A.) R Red (EU) LL Red (U.S.A.) F Green (EU) 8.3.3.2 Place 5-lead Electrodes Refer to American and European standards for placing electrodes of a 5-lead unit: White/red (right arm) electrode — Place it below the clavicle, near the right arm. Black/yellow (left arm) electrode —... -
Page 82: Place 6-Lead Electrodes
ECG Monitoring For a 5-lead configuration, place the chest (V) lead electrode at one of the following positions: V1: 4 intercostal space, at the right sternal border. V2: 4 intercostal space at the left sternal border. V3: In the middle position between V2 and V4. V4: 5 intercostal space at the left midclavicular line. -
Page 83: Recommended Ecg Lead Connections For A Surgical Patient
ECG Monitoring There are generally six electrode positions on the chest, using intercostal gap to pinpoint the positions, V1 ~ V6: V1: 4 intercostal space, at the right sternal border. V2: 4 intercostal space at the left sternal border. V3: In the middle position between C2 and C4. V4/C4: 5 intercostal space at the left mid-clavicular line. -
Page 84: Ecg Setup
ECG Monitoring 8.4 ECG Setup 8.4.1 Set the ECG Lead Type Select the ECG parameter area or waveform area to enter [ECG] menu. Select [Setup] tab. Set [Lead Type] based on the lead used. If [Auto] is selected, the Monitor will automatically detect the type of ECG lead connected. -
Page 85: Select Ecg Screen
ECG Monitoring 8.4.4 Select ECG Screen During ECG monitoring, you can select the screen as required. When using 3-lead ECG, only the Normal Screen is available. When using 5-lead ECG, the Normal Screen, the 7-Lead Full-Screen and 7-Lead Half-Screen are available. ... -
Page 86: Set Ecg Waveform
ECG Monitoring 8.4.8 Set ECG Waveform 8.4.8.1 Set Lead for ECG Waveform Displayed Select the ECG parameter or waveform area to enter [ECG] menu. Select [Setup] tab. Select [ECG] to set the lead name for each ECG waveform. If more than 3 waveforms are displayed, select [More Leads] tab and then [ECG] to set the lead name for other ECG waveforms. -
Page 87: Set Ecg Filter Mode
ECG Monitoring Select [Setup] tab. Set [Waveform Speed]. 8.4.8.5 Set ECG Filter Mode Select the ECG parameter area or waveform area to enter [ECG] menu. Select [Setup] tab. Set [Filter]. [Diagnostic]: Select it when there is a special need for diagnostic quality. In this mode, you can see the changes in waves, such as the notch of R wave, ST segment elevation or depression. -
Page 88: Set Heart Beat Marker
ECG Monitoring 8.4.8.8 Set Heart Beat Marker User can set whether to display the heart beat marker (N indicates normal heart beat; A for abnormal heart beat and P for pacing heartbeat) above the ECG waveform. Steps are as follows: Click on ECG parameter area or waveform area to enter [ECG] menu. -
Page 89: Arrhythmic Events
ECG Monitoring patient monitor for minute-to-minute clinical decision-making. The accuracy of R on T detection might be compromised on a patient with implantable cardiac defibrillator or pacemaker. Patients with intermittent ventricular pacing often trigger false ventricular alarms, especially when the nurse has neglected to activate the Pace Mode feature. -
Page 90: Non-Lethal Arrhythmia
ECG Monitoring rate threshold. Extreme Tachycardia The heart rate is greater than or equal to the limit of extreme tachycardia. Extreme Bradycardia The heart rate is less than or equal to the limit of extreme bradycardia. 8.5.2.2 Non-lethal Arrhythmia Arrhythmic Events Description R on T R on T PVC is detected. -
Page 91: Arrhythmia Setup
ECG Monitoring 8.5.3 Arrhythmia Setup 8.5.3.1 Set Arrhythmia Alarm Select the ECG parameter area or waveform area to enter [ECG] menu. Select [Arrhythmia] tab → [Alarm] tab. Set the alarm for each kind of arrhythmia as needed. NOTE The alarm priority of lethal arrhythmia is “high” priority and cannot be modified. 8.5.3.2 Set the Switch Status of Lethal Arrhythmia Alarm Select [Main Menu] →[Maintenance] of [System] column→... -
Page 92: Arrhythmia Threshold Range
ECG Monitoring Select the ECG parameter area or waveform area to enter [ECG] menu. [Arrhythmia] tab → [Threshold] tab. Set the threshold for all kinds of arrhythmias. NOTE The setting of [Asystole Delay] is associated with ECG relearning. When HR is below 30 bpm, it is recommended to set [Asystole Delay] to 10s. -
Page 93: View Hrv Parameters
ECG Monitoring 8.6.2 View HRV Parameters Select the ECG parameter area or waveform area to enter [ECG] menu. Select [Setup] tab and then [HRV] button at the bottom of the menu to enter HRV menu. Select [Parameter] tab. HRV Parameters Description Unit MEAN... -
Page 94: View Difference Histogram R-R
ECG Monitoring 8.6.4 View Difference Histogram R-R Select the ECG parameter area or waveform area to enter [ECG] menu. Select [Setup] tab and then [HRV] button at the bottom of the menu to enter [HRV] menu. Select [Difference Histogram R-R] tab. ... -
Page 95: View R-R Trend
ECG Monitoring The x-coordinate indicates an R-R interval. The y-coordinate indicates the next R-R interval. 8.6.6 View R-R Trend Select the ECG parameter area or waveform area to enter [ECG] menu. Select [Setup] tab and then [HRV] button at the bottom of the menu to enter [HRV] menu. Select [R-R Trend] tab. -
Page 96: St Segment Analysis
ECG Monitoring Select [Setup] tab and then [HRV] button at the bottom of the menu to enter [HRV] menu. Set [HRV Time ]. 8.7 ST Segment Analysis ST segment of an ECG wave is an interval between the end of ventricular depolarization and the beginning of ventricular repolarization, or a section between the end of the QRS complex (the J point) to the beginning of the T wave. -
Page 97: Set St Alarm Delay
ECG Monitoring Select [ST] tab → [Alarm] tab. Set [ST Alarm Mode] to [Absolute] or [Relative]. If selecting [Absolute], you can set each ST value alarm separately. If selecting [Relative], you can set [Single ST Alarm] and [Multiple ST Alarms] separately. Set the properties of ST alarms as required. -
Page 98: Display St Segment In Waveform Area
ECG Monitoring (4) Lead name (5) ST value：a positive number indicates ST elevation and negative for ST depression 8.7.6 Display ST Segment in Waveform area Enter the [Tile Layout] screen in any of the following ways: Select [Screen Setup] hot key → [Tile Layout] ... -
Page 99: Locate St Point, J Point And Iso Point
ECG Monitoring 8.7.9 Locate ST Point, J Point and ISO Point ST measurement, or ST segment deviation, refers to the vertical distance between the isoelectric line (ISO) and the ST point. The isoelectric line is located between the end point of the P wave and the beginning point of the QRS complex, providing a measurement baseline. -
Page 100: St View
ECG Monitoring ST point; when the patient's heart rate is less than or equal to 120bpm the system will select J+80 to locate the ST point. 8.7.10 ST View ST View displays a complete QRS waveform segment of each ST lead. You can enter [ST View] to view these ST segments. - Page 101 ECG Monitoring The figure below shows the ST Graphic when [ST Alarm Mode] is set to [Relative]. The grey diagonal line’s drawing indicates the ST real-time value. The vertical center axis is 0mV. When the ST value is in the range of 0~2.5mV, it is drawn from the vertical center axis anticlockwise to the right.
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Page 102: Qt/Qtc Monitoring
ECG Monitoring 8.8 QT/QTc Monitoring QT interval is the time from the start of QRS complex to the end of the T wave, and it represents the total time taken for ventricular action potential depolarization (QRS interval) and repolarization (ST-T). QT monitoring is helpful to identify long QT syndrome (LQTS). -
Page 103: Display Qt/Qtc Parameters And Waves
ECG Monitoring Enable [QT Analysis]. 8.8.3 Display QT/QTc Parameters and Waves Steps to display QT/QTc parameters and waves are shown below: Enter [Tile Layout] page by any of the following ways: Select [Screen Setup] hot key → [Tile Layout] tab. ... -
Page 104: Qt Setup
ECG Monitoring The current waveform is displayed at the top of the QT View screen in the same color (usually green) as the ECG waveform. The baseline segment is displayed below and in white color. The location of QRS complex and T wave end point is marked with vertical lines. ... -
Page 105: Ecg Relearn
ECG Monitoring 8.9 ECG Relearn Changes in the ECG templates may lead to false arrhythmia alarm and / or inaccurate heart rate. This Monitor provides the function of ECG Relearn, which enables the Monitor to learn new ECG templates, thus to correct false arrhythmia alarms and inaccurate heart rate values. - Page 106 ECG Monitoring Prior to defibrillation the operator should ensure that the defibrillator and the monitor are compatible. Prior to synchronous defibrillation with a defibrillator it is necessary to ensure that the Monitor is used together with the defibrillator to send a synchronous electric shock within 60ms after detection of the next R wave, and that the ECG output signal is delayed for no more than 30 ms.
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Page 107: Chapter 9 12-Lead Resting Ecg Analysis
Chapter 9 12-Lead Resting ECG Analysis 9.1 About 12-Lead Resting ECG Analysis This Monitor can be configured with the Glasgow 12-lead ECG Analysis Algorithm. This is intended to provide an interpretation of the resting 12-lead ECG. It is capable of diagnosing commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm. -
Page 108: Input Patient Information (For Glasgow Algorithm Only)
12-Lead Resting ECG Analysis 9.4.1 Input Patient Information (For Glasgow Algorithm Only) Some of the patient information directly affects the result of 12-lead analysis, so it is essential to complete the right patient information diagnostic and medical treatment. Please input patient information before performing 12 -lead analysis. -
Page 109: Save 12-Lead Report
12-Lead Resting ECG Analysis 9.5 Save 12-Lead Report After 12-lead resting ECG analysis has been completed select [Save] on the 12-Lead Report page to save the report. Section17.8 12-Lead Report Review You can review the saved 12-Lead Report. Please refer to " "... -
Page 110: Chapter 10 Resp Monitoring
Chapter 10 Resp Monitoring 10.1 Resp(Respiration) Measurement The monitor measures the respiration based on the thoracic impedance between the two electrodes. The changes of such impedance caused by thoracic movements generate a respiratory waveform on the screen. The RR is calculated from such a waveform. -
Page 111: Resp Display
RESP Monitoring 10.3 Resp Display (1) Parameter (2) Waveform gain (3)Lead label (4) Respiration Rate（RR) (5) RR source (6) RR alarm limit 10.4 Placement of Electrodes In Resp measurement it is important to prepare the skin properly for electrode placement. Refer to the ECG measurement section or relevant information. -
Page 112: Resp Setup
RESP Monitoring Some patients may have restricted thoracic movements and rely mainly on abdominal respiration. To obtain the best Resp waveform, place the electrode LL on the left abdomen with strongest expansion, as shown below: 10.5 Resp Setup 10.5.1 Set Resp Alarm Select the respiration parameter area or waveform area to enter [Resp] menu. -
Page 113: Set Resp Lead
RESP Monitoring 10.5.4 Set Resp Lead RESP lead indicates the source of the current RESP waveform. If you select [Auto] the monitor will automatically select an appropriate respiration lead. Select the respiration parameter area or waveform area to enter [Resp] menu. Select [Setup] tab. -
Page 114: Manually Adjust Resp Wave Detection Threshold
RESP Monitoring When [Auto Threshold Detection] is [On] during Resp Monitoring and ECG Monitoring is [Off], the monitor cannot compare the heart rate and Resp rates to detect cardiovascular artifact. The respiration detection level is automatically set higher to prevent the detection of cardiovascular artifact as respiration. When [Auto Threshold Detection] is [Off], cardiovascular artifact can, in certain situations, trigger the respiration rate counter. -
Page 115: Chapter 11 Spo 2 Monitoring
The information about wavelength range and maximum optical output power of the sensor is useful to the clinician for some therapies, for example, photodynamic therapy. The Comen SpO sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED). ... -
Page 116: Safety Information
WARNING The Monitor is compatible with the SpO sensor specified by Comen only. Before monitoring the patient please check if the sensor and extension cord are compatible with the Monitor. Incompatible accessories may reduce the performance of the Monitor. - Page 117 NIBP Monitoring To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. To protect against injury, follow the directions below: Avoid placing the device on surfaces with visible liquid spills. Do not soak or immerse the device in liquids. ...
- Page 118 NIBP Monitoring accurate, and the operator should additionally validate the values and the patient’s status. CAUTION Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any power source. When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy.
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Page 119: Masimo Spo2 Specific Information
NIBP Monitoring The pulse oximeter device is calibrated to display functional blood oxygen saturation. Validation of the accuracy of SpO measurement: The accuracy of Masimo SpO has been validated in comparison with the reference value of arterial blood samples measured by CO-oxygen manometers in clinical investigation. -
Page 120: Measurement Restrictions
NIBP Monitoring 11.3 Measurement Restrictions Inaccurate SpO readings may be caused by the following factors: High-frequency radio interference, whether from the host system or from the electrosurgical equipment connected to the host system. To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to the instrument. -
Page 121: Low Perfusion Accuracy Test
(ΔSpO (8) SpO sensitivity. (9) Bar graph (Signal Identification and Quality) (For Masimo and Comen SpO ): Proportional to the pulse intensity. Bar graph can reflect the filling state of blood. When the signal quality is low, the accuracy of SpO measurement maybe compromised. -
Page 122: Placement Of The Spo 2 Sensor
NIBP Monitoring 11.7 Placement of the SpO Sensor WARNING Check the patient’s skin every two hours to ensure good skin quality and lighting. In case of any skin change, move the sensor to another location. Change the sensor location at least every four hours. ... -
Page 123: Placement Of A Disposable Spo Sensor
NIBP Monitoring 11.7.3 Placement of a Disposable SpO Sensor Fig. 1 Fig. 2 Fig. 3 Fig. 4 For fragile skin, the stickiness of the medical grade adhesive can be diminished or eliminated by daubing the adhesive areas with a cotton ball or with gauze (Refer to Fig. 1). Direct the sensor cable so that it either points away from the patient or runs along the bottom of the foot. -
Page 124: Set Spo Sensor Off
NIBP Monitoring NOTE Only when the [SpO Desat Alarm Off] is set to [Enable], can you turn off SpO Desat Alarm. Please Section7.10 Set SpO Desat Alarm refer to " " for more information. 11.8.2 Set SpO sensor off You can set SpO sensor off Alarm Priority by the following steps: Select [Main Menu] hot key →... -
Page 125: Set Sensitivity (For Masimo Spo Only)
NIBP Monitoring Calculation method: Percentage points × seconds = SatSeconds (integer) The calculated SatSeconds is displayed as follows: %SpO Seconds SatSeconds （90%-80%） × 3 = （90%-78%） × 2 = Total SatSeconds = 54 In the above SatSeconds example: About 4.9s later, the Monitor will report a SatSeconds alarm because you've set [SatSeconds] to [50], smaller than The SpO value may fluctuate in seconds rather than remain unchanged. -
Page 126: Set Average Time (Not For Nellcor Spo )
] menu. Select [SpO Setup] tab. Set [Average Time] to [2-4], [4-6], [8], [10], [12], [14] or [16], the unit is s. 11.8.7.2 Average Time for Comen SpO Select the SpO parameter area or waveform area to enter [SpO ] menu. -
Page 127: Set Signal Iq (Not For Nellcor Spo )
NIBP Monitoring To set [Smart Tone]: Select the SpO parameter area to enter [SpO ] menu. Turn on or off [Smart Tone]. 11.8.10 Set Signal IQ (Not for Nellcor SpO The magnitude of the SpO SIQ waveform provides an assessment of the confidence in the measurement. A higher value indicates higher confidence in the measurement whereas a smaller value indicates lower confidence. -
Page 128: Set Pulse Volume
NIBP Monitoring Select [PR Source], and select an appropriate PR source in the drop-down list. The drop-down list of [PR Source] shows the currently valid PR sources by their priority. If you select [Auto] the system will automatically use the first option in the list as the PR source. If the PR source you set doesn't exist, the system will automatically switch [PR Source] to [Auto]. -
Page 129: Chapter 12 Nibp Monitoring
NIBP Monitoring Chapter 12 NIBP Monitoring 12.1 Overview The Monitor uses the oscillometric method to measure the non-invasive blood pressure (NIBP). The cuff pressure at the highest oscillation amplitude is the mean pressure. The systolic pressure and diastolic pressure are calculated from the mean pressure. -
Page 130: Measurement Restrictions
NIBP Monitoring NOTE If you have any doubt about the reading accuracy, check the patient's vital signs first before checking the Monitor's functions. When unexpected values measured, check potential causes, such - the incorrect cuff size was used or the cuff is not placed at heart level. - excessive patient movement. -
Page 131: Nibp Display
NIBP Monitoring Adjust his/her sitting posture until: He/she sits comfortably; His/her legs are not crossed; His/her feet are laid flat on the ground; He/she leans his/her back against the chair and puts his/her hands on the desk; ... -
Page 132: Display Nibp List
NIBP Monitoring 12.5 Display NIBP List You can display multiple sets of NIBP results measured recently in the parameter area by the following steps: Enter [Tile Layout] in any of the following ways: Select [Screen Setup] hot key → [Tile Layout] ... -
Page 133: Set Nibp Measure Sequence
NIBP Monitoring 12.6.5 Set NIBP Measure Sequence NIBP measure sequence includes up to five measurement cycles: A, B, C, D and E. You can separately set the times and interval for each measurement cycle in the following way: Select the NIBP parameter area to enter [NIBP] menu. Select [Sequence] tab. -
Page 134: Start Nibp Measurement
NIBP Monitoring you fail to do so, use the following methods to correct the measurement result: Make sure the mark “φ” is located at an appropriate artery. Do not wrap or secure the cuff too tightly, or the distal extremity may suffer from discoloration or ischemia. Regularly check the skin condition of the contact part and the color, temperature and feeling of the limb which wears the cuff. -
Page 135: Start Nibp Stat
NIBP Monitoring Select [Setup] tab. Set [Start Mode] to [Clock]. Select the drop-down list on the right of [Interval] and set the specific measurement interval. Select [NIBP Start/Stop] hot key or select [Start NIBP] in [NIBP] menu to start the first measurement. Or you can select [Clock], and then [NIBP Setup] →... -
Page 136: Stop Nibp Measurement
NIBP Monitoring 12.7.3 Stop NIBP measurement 12.7.3.1 Stop Ongoing Measurement You can stop the ongoing NIBP measurement in any of the following ways: Select [NIBP Start/Stop] hot key. Select the NIBP parameter area to enter [NIBP] menu → select [Stop NIBP]. 12.7.3.2 Stop NIBP STAT You can stop NIBP STAT in any of the following ways: ... -
Page 137: Nibp Analysis
NIBP Monitoring 12.9 NIBP Analysis At the NIBP analysis interface you can review the patient's systolic pressure and diastolic pressure, the percentage of higher/lower values and the average, maximum and minimum systolic pressure and diastolic pressure within the measurement time. Select the NIBP parameter area to enter [NIBP] menu. - Page 138 NIBP Monitoring Blank Page 12-10...
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Page 139: Chapter 13 Temp Monitoring
Chapter 13 TEMP Monitoring 13.1 TEMP Overview The monitor uses temperature probes to measure the body temperature and supports two temperature measurement channels. By placing the temperature probe under the patient’s axilla or rectal, the monitor displays the temperature directly measured at the measurement site. . TEMP measurement is intended for adult, pediatric and neonatal patients. -
Page 140: Temperature Setup
TEMP Monitoring Place the temperature sensor on the measurement site reliably. Section 13.5.3 Set Temp Type Set the temperature sensor type; please refer to “ ” for more information. WARNING Before temperature measurement ensure that the temperature probe cable is in good condition. Remove the temperature sensor cable from connector, and the monitor displays the prompt message [T1 (T2) sensor off] and triggers an audio alarm. -
Page 141: Set Temp Sensor Type
TEMP Monitoring Set [ΔT] to On. 13.5.3 Set Temp Sensor Type Select [Main Menu] → [System] → [Maintenance], enter the maintenance password and click the Enter key. Select [Other] tab. Set [Temp Sensor Type] based on the type of Temp sensor used. 13.5.4 Turn Off Dual Temp Display [Dual Temp Display] defaults to [On];... -
Page 142: Chapter 14 Ibp Monitoring
Chapter 14 IBP Monitoring 14.1 Overview This monitor supports 2-channel invasive blood pressure (IBP) measurement, and can be directly used to measure IBP. IBP measurement is intended for adult, pediatric and neonatal patients. 14.2 Safety Information WARNING Do not touch the metal parts connected to electrical equipment when connecting or using any accessory. ... -
Page 143: Monitoring Steps
IBP Monitoring 14.3 Monitoring Steps 14.3.1 IBP Assembly (1) Pressure sensor (2) Pressure sensor interface cable (3) Monitor (4) Three-way switch (5) Pipette (6) Valve (7) Solution 14.3.2 Measurement Steps Insert the IBP module into the monitor. Insert one end of the IBP sensor cable into the IBP connector, and connect the other end to the IBP transducer. -
Page 144: Zero The Pressure Sensor
IBP Monitoring NOTE Once the monitor detects a disconnected arterial catheter it will activate a high priority alarm condition “XX (IBP label) pulse not found”. Once the monitor detects a transduce wire or IBP cable fault (opened or shorted), or transducer connector unplugged, it will activate a technical alarm condition. -
Page 145: Ibp Setup
IBP Monitoring (6) (7) (1) Parameter (2) Systolic pressure alarm limit (3) Systolic pressure (4) Diastolic pressure (5) Diastolic pressure alarm limit (6) Mean Pressure (7) Mean pressure alarm limit 14.5 IBP Setup 14.5.1 Set IBP Alarm Select the IBP parameter area or waveform area to enter the corresponding IBP menu. Select [Alarm] tab. -
Page 146: Display Pressure Type
IBP Monitoring Label Description Label Description Cerebral perfusion Left ventricular pressure pressure NOTE Do not select the same label for IBP channels. 14.5.4 Display Pressure Type If the current pressure is an expansion pressure (P1, P2, P3 or P4) you can select the pressure type displayed in the parameter area by the following method: Select the expansion pressure parameter area or waveform area to enter the corresponding pressure menu. -
Page 147: Set Ibp Sensor Type
IBP Monitoring 14.5.8 Set IBP Sensor Type Select [Main Menu] hot key → [System] → [Maintenance], enter the maintenance password and click the Enter key. Select [Module] tab → [IBP] tab. Select [Sensor Type]. 14.5.9 Change Pressure Unit Select [Main Menu] hot key → [System] → [Maintenance], enter the maintenance password and click the Enter key. -
Page 148: Set Filter Mode
IBP Monitoring NOTE CVP scale unit is consistent with CVP parameter unit. 14.5.11 Set Filter Mode Select [Main Menu] hot key → [System] → [Maintenance], enter the maintenance password and click the Enter key. Select [Module] tab → [Other] tab. Set [IBP Filter]: ... -
Page 149: Pawp Measurement Screen
IBP Monitoring PAWP reflects the changes of intracranial pressure during the whole respiratory cycle. When the airway pressure and valvular function normally, PAWP is the left ventricular end-diastolic pressure. The PAWP value measured at the end of a respiratory cycle is the most accurate since the intracranial pressure is fairly constant. 14.6.1 PAWP Measurement Screen Select [Screen Setup] →[Choose Screen] →[PAWP] into the PAWP measurement interface. -
Page 150: Pawp Equipment Assembly
IBP Monitoring 14.6.2 PAWP Equipment Assembly (1) IBP Module (2) Solution (3) IBP Sensor (4) Three-way Switch (5) Remote PA Interface (6) Balloon Charge Valve (7) Swan-Ganz Catheter (8) Balloon 14.6.3 Preparations for Measurement WARNING Before measurement, please read the instructions for the Swan-Ganz catheter and IBP sensor. Connect the IBP sensor, IBP cable and module;... -
Page 151: Measurement Steps
IBP Monitoring 14.6.4 Measurement Steps 1. Select PA parameter area or waveform area. Wedge the tip of the Swan-Ganz catheter into the patient's pulmonary arteriole properly and then inflate the balloon, and the PA waveform displayed by the monitor will change. Please pay close attention to the change of PA waveform, shown as the figure below: 2. -
Page 152: Hemodynamic Calculation
IBP Monitoring Reference All available ECG leads Select an ECG waveform to display in PAWP Waveform1 waveform area as the first reference waveform. Reference Resp; CO Select a respiration waveform or CO Waveform2 waveform t displayin PAWP waveform area as the second reference waveform Speed 12.5mm/s;25mm/s;50mm/s... -
Page 153: Chapter 15 Co 2 Monitoring
Chapter 15 CO Monitoring 15.1 Overview The monitor uses the CO gas analyzer to monitor the patient’s respiration gas and control patient’s ventilation. There are two methods of measuring the CO in the patient’s airway: Sidestream measurement method: portion of a patient’s respired gases from the sampling site, through a sampling tube, to the sensor within CO module for analysis. -
Page 154: Safety Information
Monitoring 15.2 Safety Information WARNING When placing a sampling line and other wires, take care to prevent the patient from strangulation or asphyxiation Never use this device in an environment with inflammable anesthetic gases. Only trained professionals familiar with this Manual are allowed to operate the device. ... -
Page 155: Co Display
Monitoring The total pressure of the gas mixture is measured by a cuvette pressure sensor. To convert into any other unit, use the actual barometric pressure sent from the ISA sidestream (IRMA mainstream). (mmHg) = (CO Concentration) x (Barometric Pressure from ISA (kPa)) x (750 / 100). Take 5.0 vol% CO @ 101.3kPa as an example: 0.05 x 101.3 x 750 / 100 = 38 (mmHg). -
Page 156: Co Measurement
Connect the mainstream sensor to the CO interface of the monitor. Wait for 10s (Masimo CO module) or 2min (Respironics and Comen CO module) until the module reaches its working temperature and a stable thermal state. Place the airway adapter on the mainstream CO module. -
Page 157: Preparations For Sidestream Co Sensor Connection
Plug-in module Insert the plug-in module to the monitor's interface. Wait for 10s (Masimo CO module) or 2min (Respironics and COMEN CO module) until the sensor reaches its working temperature and a stable thermal state. Insert the sampling line into the interface of the CO module securely until you hear a "click"... -
Page 158: Preparations For Respironics Sidestream Co Module (Other Than Plug-In Module)
Monitoring (1) Sampling line (2) Y-shaped tube (3) Airway adapter (4) Respiration circuit port (5) Elbow tube Placement of the nasal cannula for the patient without tracheal cannula: place the nasal or oral-nasal with O cannula onto the patient's face, connect the O therapy tube to the O supply system and set the O flow as... -
Page 159: Preparations For Masimo Sidestream Co Module (Other Than Plug-In Module)
Monitoring patient's face. Connect an exhaust pipe to the vent on the sensor so as to exhaust waste gases into the waste gas treatment system. Start the measurement after confirming the airway tightness. 15.5.2.3 Preparations for Masimo Sidestream CO Module (other than plug-in module) Connect one end of the Masimo patch cable with the CO sensor cable. -
Page 160: Preparations For Comen Sidestream Co Module (Other Than Plug-In Module)
Monitoring 15.5.2.4 Preparations for Comen Sidestream CO Module (other than plug-in module) Insert the CO module to the monitor's CO interface. Wait for 2min until the sensor reaches its working temperature and a stable thermal state. Insert the sampling line into the interface of the CO sensor securely until you hear a "click"... -
Page 161: Zeroing The Co Sensor
24 hours. The Masimo CO sensor finishes auto zeroing within 3s. 15.6.2 Zeroing the Respironics & Comen Mainstream CO Module In order to eliminate the effect of baseline drift on measurement results and obtain accurate measurement results,... -
Page 162: Co Setup
Monitoring NOTE For the best zeroing result, please zero the Respironics CO sensor after preheating for 5min. 15.7 CO Setup 15.7.1 Set CO Alarm Select the CO parameter area or waveform area to enter [CO ] menu. Select [Alarm] tab. Set the alarm as required. -
Page 163: Set Scale
O Compensation]: set as required. RESPIRONICS CO Module: Compensation]: Choose the appropriate value according to the O content in the measured gas. COMEN CO Module: Compensation]: Choose the appropriate value according to the O content in the measured gas. WARNING ... -
Page 164: Set Balance Gas
Monitoring 15.7.8 Set Balance Gas Manual setup of balance gas is available for RESPIRONICS and COMEN CO modules only, and balance gas is set automatically for the MASIMO CO module. Select the CO parameter area or waveform area to enter [CO ] menu. - Page 165 Monitoring 2,000 609.6 2,500 3,000 914.9 3,500 1066.8 4,000 1219.2 4,500 1371.6 5,000 1524 5,500 1676.4 6,000 1828.8 6,500 1981.2 7,000 2133.6 7,500 2286 8,000 2438.4 8,500 2590.8 9,000 2743.2 10,000 3048 10,500 3200.4 11,000 3352.8 11,500 3505.2 12,000 3657.6 12,500 3810 13,000...
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Page 166: Enter Intubation Mode
Monitoring WARNING Set the correct altitude before using the CO measurement function for the first time. Incorrect altitude causes incorrect CO reading (5% CO error per 1,000m altitude difference). 15.7.11 Enter Intubation Mode. If the currently monitored patient is under the intubation process of a general anesthesia surgery, the monitor can be set to Intubation Mode to shield unnecessary alarms. -
Page 167: Irma Mainstream Gas Module
Monitoring Dispose of Nomoline Family sampling lines in accordance with local regulations for biohazardous waste. Use only airway T-adapters with the sampling point in the center of the adapter. Do only use sample lines intended for anesthetic agents if N O and/or anesthetic agents are being used. -
Page 168: Airway Obstruction
Monitoring infection. Used airway adapters shall be disposed of in accordance with local regulations for biohazardous waste. Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml dead space to the patient circuit. ... -
Page 169: Safety Symbols
Monitoring 15.9.4 Safety Symbols Text, Color Code and Text Symbol Description Format “Warning” indicates the hazardous conditions causing Warning: additional possible personal injuries or death. The warning symbol information. should comply with ISO 7010-W001. User’s Manual Refer to the User’s Manual. Reference No. -
Page 170: Patents And Trademarks
Monitoring Illustrates the connection between the Nomoline and Connect to patient circuit patient circuit. Connect to ISA Illustrate the connection between Nomoline and ISA. Not sterile, latex free The Monitor is latex free and not sterile. 15.9.5 Patents and Trademarks Patent Statement Masimo Sweden AB owns the following patents for relevant products described in this operating instruction manual: SE519766;... -
Page 171: Irma Airway Adapter
Monitoring Figure 1.The disposable Nomoline Airway Adapter Set is an alternative to using a combination of the multiple patient use Nomoline Adapter and a disposable Nomoline Extension / T-adapter. The Nomoline Adapter may be used with other third party sampling lines and cannulas. Please however note that the Nomoline Family of sampling lines are designed for optimal performance and measurement fidelity when used with the ISA gas analyzers. -
Page 172: Maintenance
Monitoring WARNING Replace the airway adapter if rainout/condensation occurs inside the airway adapter. The IRMA airway adapter is designed as a non-sterile single patient use disposable for both Adult/Pediatric and Infant applications. The IRMA Infant airway adapter has specially designed connectors for minimizing the dead space and can be used even for very small patients. -
Page 173: Chapter 16 C.o. Monitoring
Chapter 16 C.O. Monitoring 16.1 Overview C.O. (cardiac output) measurement uses the regular thermodilution method to measure the C.O. and other hemodynamic parameters in an invasive way. The monitor can measure the blood temperature, and calculate cardiac output and hemodynamics. Place the drift catheter into the vein and then let the tube reach the pulmonary artery. -
Page 174: Measurement Limitations
C.O. Monitoring Please use the accessories specified herein, and avoid contact with conductive metal parts during connection and use of accessories. 16.3 C.O. Measurement Limitations Factors causing measurement error: Patient movements in the measurement; Anxious patient; ... -
Page 175: Setup
C.O. Monitoring 16.5 C.O. Setup 16.5.1 Set BT Alarm Select the C.O. parameter area to enter [C.O.] menu. Select [Alarm] tab. Set the alarm as required. 16.5.2 Set TEMP Unit Select [Main Menu] hot key → [System] → [Maintenance], enter the maintenance password and click the Enter key. -
Page 176: Set Injection Temp
C.O. Monitoring Set [Interval (s)]: the minimum time interval between two measurements; the next measurement will not be carried out until the set interval is reached. 16.5.6 Set C.O. Coefficient Select the C.O. parameter area to enter [C.O.] menu. Select [Setup] tab. Set [C.O. -
Page 177: Preparations For Measurement
C.O. Monitoring Do not touch any conductive metal when an accessory is used. Select an injection solution volume and computation coefficient for the drift catheter. Enter the computation coefficient as instructed in the User’s Manual of the drift catheter after replacement. ... -
Page 178: Measure
C.O. Monitoring 16.6.3 C.O. Measure Set C.O. Measure as follows: Select the C.O. parameter area to enter [C.O.] menu. Select [Measure] tab. If [Auto Start] is disabled, select [Start] to start fast injection (do not exceed 4s). The Thermodilution curve will be displayed in the C.O. - Page 179 C.O. Monitoring (3) Average (4) C.O. Coefficient and BSA (5) Currently measured values and C.O. curve (6) Functional keys NOTE If the blood temperature (BT) is unstable during measurement, it may lead to measurement failure. BT alarm is not available during C.O. measurement. After the measurement, the BT alarm becomes available automatically.
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Page 180: Chapter 17 Data Review
Chapter 17 Data review 17.1 Overview On the Review screen, you can view the trend data, alarm event records and waveform information. You can also go to the Minitrends screen or OxyCRG screen to view trend data. Here we explain how to view such stored data. 17.2 Review Screen 17.2.1 Go to the Review Screen Follow any path described below to go to the Review screen:... -
Page 181: Icons On The Review Screen
Clinical Assistant Assessment (CAA) (5) Button area. (6) Slider: indicates the position of the current screen as part of the full time period. You can move the slider left or right to locate the trend data at a specific time, and the trend data displayed in the current screen will be updated accordingly. -
Page 182: Change The Time Step Of Tabular Trends
Clinical Assistant Assessment (CAA) 17.4.3 Change the Time Step of Tabular Trends Time step refers to the time interval of the trend data displayed on the screen. You can select a larger time step for neonatal patients as their clinical conditions may change rapidly, and select a smaller time step for adult patients as their clinical conditions will change relatively slowly. -
Page 183: Set The Window Time
Clinical Assistant Assessment (CAA) 17.5.2 Set the Window Time You can follow the steps below to set the time length of the trend data displayed in each screen: Go to the Graphic Trends page; Set [Zoom] to: [8min]: to display 8min trend data in each screen (you can view the trends of the last 1h); ... -
Page 184: Go To The Events Page
Clinical Assistant Assessment (CAA) NOTE The stored events will never be lost due to power failure. When exceeding 2000, the earliest record will be overwritten by the latest event. The system will save the logs before the power is cut off normally. When the power is cut off abnormally, ensure that the logs are saved 3s before the power cut. -
Page 185: Edit Events
Clinical Assistant Assessment (CAA) 17.6.3 Edit Events On the Events page, check the events to be edited; Click [...] to edit the checked events: [Select All]: check the whole event list. [Note]: enter a note to the event. ... -
Page 186: Select Compressed Waveforms
Clinical Assistant Assessment (CAA) 17.7.2 Select Compressed Waveforms To review compressed waveforms you must first follow the steps below to select the parameter waveforms to be stored and displayed: Go to the Full-Disclosure Waveforms page; Click [Setup] tab and select the waveforms to be stored; Click [Waveform] and select the stored waveforms to be displayed. -
Page 187: 12-Lead Report Review
Clinical Assistant Assessment (CAA) 17.8 12-Lead Report Review On the 12-Lead Report Review page, you can review the last 20 12-lead ECG events and their analysis and diagnosis Section 9 12-Lead Resting ECG Analysis” results. See “ for more 12-lead ECG information. 17.8.1 Go to the 12-Lead ECG Page Follow any path described below to go to the 12-Lead ECG page: ... -
Page 188: Go To The St Page
Clinical Assistant Assessment (CAA) 17.9 ST If the ST Analysis option is enabled the Monitor will save the ST-segment data and waveforms at a 5min interval. You can go to the ST page to view such data and waveforms. 17.9.1 Go to the ST Page Follow either path described below to go to the ST page: ... -
Page 189: Minitrends
Clinical Assistant Assessment (CAA) Click " ". 17.10 Minitrends The Minitrends window is located in the left of the waveform area and displays the trends of a series of parameters in the most recent period. If the Monitor is integrated with an external device, you can also view the Minitrends of the external device in the Minitrends window. -
Page 190: Oxycrg
Clinical Assistant Assessment (CAA) 17.11 OxyCRG Follow either path described below to go to the OxyCRG screen: Click [Screen Setup] hot key → [OxyCRG]; or Click [Main Menu] hot key → [Display] → [Choose Screen] → [OxyCRG]. Two trend curves and one compressed waveform are displayed on the OxyCRG screen. 17.11.1 Select Parameters and Scale Go to the [OxyCRG] screen;... -
Page 191: Chapter 18 Clinical Assistant Assessment (Caa)
Clinical Assistant Assessment (CAA) Chapter 18 Clinical Assistant Assessment (CAA) 18.1 SepsisGuide The SepsisGuide function provides sepsis screening and treatment tracking tools according to Sepsis -3 (Third Surviving Sepsis Campaign - International International Consensus Definitions for Sepsis and Septic Shock) and the Guidelines for Treatment of Severe Sepsis and Septic Shock - 2012 ("SSC Guidelines"), for the user to screen patients for sepsis at the bedside and track sepsis patients for achievement of resuscitation goals and completion of therapy. -
Page 192: Sofa Scoring
Clinical Assistant Assessment (CAA) NOTE If the score value is a question mark "?", that means more parameter values are needed for scoring. 18.1.2.2 SOFA Scoring The SOFA score is the score of systemic infection-related organ failure or the score of sequential organ failure. Check each scoring item or enter the parameter value of each scoring item manually, and the Monitor will automatically calculate the total score. -
Page 193: Ssc Setup
Clinical Assistant Assessment (CAA) general therapy item. Select [Reset] to clear the records. 18.1.4 SSC Setup In the SepsisGuide menu, click [Setup] to set the following parameters: In the [Screening] area, set the positive threshold of RR and BP-S (qSOFA scoring parameters). ... -
Page 194: Score Calculation
Clinical Assistant Assessment (CAA) Select [Screen Setup]→[Choose Screen] tab→[EWS] Click [Main Menu] hot key → [Display] → [Choose Screen] → [EWS]. Take MEWS as an example, the EWS screen is illustrated below. The actual EWS screen may be different, depending on the selected scoring system and settings. -
Page 195: Auto Scoring
Clinical Assistant Assessment (CAA) patients with hypercapnic respiratory failure). Measure the values of other parameters or enter them manually. Click [Calculate] to obtain the score results. NOTE The decision to use Scale 2 of the SpO Scale should be made by a competent clinical decision maker and should be recorded in the patient’s clinical notes. -
Page 196: Set The Timeout Of Parameters
Clinical Assistant Assessment (CAA) 18.2.4.3 Set the Timeout of Parameters You can follow the steps below to set the timeout of manually entered parameter values: On the EWS screen, click [MEWS] tab → [Setup]. Set the [Manual Data Timeout]. 18.2.5 EWS Review On the EWS screen, click [Tabular Trends] or [Graphic Trends] tab to view the measured/entered values and scores of all involved parameters.. -
Page 197: Gcs Scoring
Clinical Assistant Assessment (CAA) (1) Individual Score (2) Total Score 18.3.2 GCS Scoring On the GCS screen, check an option in the [Eye Opening], [Verbal Response] and [Motor Response] area respectively based on the patient's actual condition. Click [OK] to confirm the score results. The score range and background color of each score level are listed in the table below: Level Score Range... -
Page 198: Go To The Ecg 24H Summary Window
Clinical Assistant Assessment (CAA) Statistics of maximum and minimum ST values for each lead; Pacer statistics; Typical ECG waveforms. NOTE ECG 24H Summary only applies to the current patient, not historical patients. Pacer statistics only apply to patients wearing pacemakers. ... -
Page 199: Access To Pacer View Window
Clinical Assistant Assessment (CAA) A license is required for the Pacer View function. The Pacer View function can only be activated and used when the admitted patient’s paced status [Pacer] is set to [Yes]. If [Pacer] is set to [No] or unspecified, this function cannot be used 18.5.1 Access to Pacer View Window You can use either of the following options to open the Pacer View: ... -
Page 200: Cchd (Critical Congenital Heart Disease) Screening
Clinical Assistant Assessment (CAA) 18.6 CCHD (Critical Congenital Heart Disease) Screening The pulse-oximetry monitoring can be used for screening for critical congenital heart disease (CCHD). CCHD screening primarily targets seven specific lesions: hypoplastic left heart syndrome, pulmonary atresia, Tetralogy of Fallot (TOF), total anomalous pulmonary venous return, transposition of the great arteries, tricuspid atresia and truncus arteriosus. - Page 201 Clinical Assistant Assessment (CAA) Newborn in well-infant nursery 24-48h of age or shortly before discharge if < 24h of age Screen 90%-95%SpO in RH or F or＞3% ≥ 95%SpO in RH or F and ≤3% ＜ 90%SpO in RH (Right difference between RH and F difference between RH and F hand）or F (Foot)
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Page 202: Select Cchd Screening Rule
Clinical Assistant Assessment (CAA) Another screening rule of CCHD is Two Standards (SpO and Heart Murmur), which follows the procedure as shown below: Newborn in well-infant nursery 6-7h of age Heart Murmur ≥ 2 level 90%-94%SpO in RH or F or＞3% ＜90%SpO in RH (Right difference between RH and F... -
Page 203: Access To The Cchd Screening
Clinical Assistant Assessment (CAA) American Standard Two Standard (1) SpO measurement values and measuring time (2) SpO value measured on the right hand (3) SpO value measured on one foot (4) Click on this icon to switch the SpO measurement values between right hand and foot if required (5) Set heart-murmur level (6) Screening results and recommended actions 18.6.3 Access to the CCHD Screening... -
Page 204: Start Cchd Screening
Clinical Assistant Assessment (CAA) 18.6.4 Start CCHD Screening If the monitor you purchased is configured with two kinds of SpO module (KPM module and SpO plug-in module), you can measure the SpO in the right hand and foot simultaneously to detect CCHD. If only one SpO module is configured, you can measure the SpO on the right hand first and then change to the foot. -
Page 205: Chapter 19 Calculation
The meditation dose must be decided by the attending physician. Please check the correctness of entered parameter values and the suitability of calculation results carefully when performing calculations. Comen is not responsible for any consequences caused by incorrect inputs or operations. 19.3 Drug calculation The monitor provides the calculation and titration display functions for 15 kinds of meditations. -
Page 206: View The Titration Table
Calculation Click [Main Menu] hot key → [Calculations] → [Drug]. Set the [Drug Name], [Patient Type] and [Weight]. Enter the values of Amount, Drop Size and Dose. Click [Calculate] to start the calculation. NOTE When you arrive at the Drug Calculate page for the first time, the values of Patient Category and Weight recorded in the Patient Management menu will be automatically transferred into the Drug Calculation menu. -
Page 207: Hemodynamic Calculation
Calculation 19.4 Hemodynamic Calculation 19.4.1 Calculation Steps Follow either step described below to go to the Hemodynamic page: Click [Calculations] hot key → [Hemodynamic] tab; or Click [Main Menu] hot key → [Calculations] → [Hemodynamic]. Enter the correct value of each parameter. For the patient being monitored the Monitor will take the measured value as the input value and import the height and weight value from the entered patient information. - Page 208 Calculation Stroke volume ml/m Stroke index DS/cm Systemic vascular resistance SVRI DS.m Systemic vascular resistance index DS/cm Pulmonary vascular resistance PVRI DS.m Pulmonary vascular resistance index Kg.m Left cardiac work LCWI Kg.m/m Left cardiac work index LVSW Left ventricular stroke work LVSWI g.m/m Left ventricular stroke work index...
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Page 209: Input Parameters
Calculation 19.5.1 Input Parameters Abbreviation Unit Full Name C.O. l/min Cardiac output Percentage fraction of inspired oxygen Partial pressure of carbon dioxide in the PaCO mmHg arteries mmHg Partial pressure of oxygen in the arteries Arterial oxygen saturation 3+Partial pressure of oxygen in venous mmHg blood Venous oxygen saturation... -
Page 210: Ventilation Calculation
Calculation Qs/Qt Venous admixture C.O. Calc l/min Calculated cardiac output 19.6 Ventilation Calculation Follow either path described below to go to the Ventilation page: Click [Calculations] hot key → [Ventilation] tab; or Click [Main Menu] hot key → [Calculations] → [Ventilation]. Enter the correct value of each parameter. -
Page 211: Output Parameters
Calculation 19.6.2 Output Parameters Abbreviation Unit Full Name mmHg Partial pressure of oxygen in the alveoli AaDO mmHg Alveolar-arterial oxygen difference Pa/FiO mmHg Oxygenation ratio a/AO Arterial to alveolar oxygen ratio l/min/m Minute volume Volume of physiological dead space Physiologic dead space in percent of tidal Vd/Vt volume l/min... -
Page 212: Output Parameters
Calculation mOsm/kgH Uosm Urine osmolality SerNa mmol/l Serum sodium mol/l Creatinine mol/l Urine creatinine mmol/l Blood urea nitrogen Height Height Weight Weight 19.7.2 Output Parameters Abbreviation Unit Full Name URNaEx mmol/24h Urine sodium excretion URKEx mmol/24h Urine potassium excretion Na/K Sodium potassium ratio ml/24h Clearance of sodium... -
Page 213: Chapter 20 Record
Chapter 20 Record 20.1 Description of Recorder This monitor uses a thermal array recorder to record and print patient information, measurement data, reviews and maximum 3 waveforms. (1) Fault alarm light (2) On/Off latch lock (3) Recorder door (4) Power indicator 20.2 Start Recording 20.2.1 Start Recording Manually ... -
Page 214: Stop Recording
Record 20.3 Stop Recording 20.3.1 Stop Recording Manually During the recording process, click " " to stop recording. Go to the [Record Setup] menu to click [Clear Record Task]. 20.3.2 Stop Recording Automatically The Recorder will stop recording automatically in the following cases: ... -
Page 215: Clear Record Task
Record Click [Alarm Setup] hot key; Click the corresponding parameter area or waveform area → [Alarm] tab; or Click [Parameters Setup] hot key, select the desired parameter and then click [Alarm] tab. Enable [Alarm Output]. 20.6 Clear Record Task Click [Main Menu] hot key →... - Page 216 Record Prior to cleaning, measures like wearing an antistatic strap should be taken to prevent the device from being damaged by static electricity. Open the recorder door; take out the record paper, and use a cotton ball to dip an appropriate amount of alcohol.
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Page 217: Chapter 21 Print
Chapter 21 Print 21.1 Printer The Monitor can output patient reports through a USB cable connected to a printer or networked printer. Currently, the monitor supports the following types of printers that comply with IEC 60950-1 and relevant safety standards. Specification of reports printed by the printer: ... -
Page 218: Manual Printing
Print Set the [Paper Size]. Then you can click [Print Test Page] to start printing in order to verify whether the printer works properly. 21.4 Manual Printing 21.4.1 Start Printing on the Current Page To print the real-time report, click [Realtime Print] hot key or go to the [Normal Report] page to click [Realtime Section 21.4.2 Print Normal Reports”... -
Page 219: Set The Printed Report
Print 21.6 Set the Printed Report 21.6.1 Set the ECG Report Click [Main Menu] hot key → [Report] →[Normal Report]. Click [ECG Report]. Set the desired menu items. Part of menu items are described in the table below. Menu Item Function Description Amplitude... -
Page 220: Set The Graphic Trends Report
Print Click [Tabular Trends Report]. Set the desired menu items. Part of menu items are described in the table below. Menu Item Function Description Period Print the tabular trends report The print time period can be set as: [30min], [1h], [2h] and of a specific time period. -
Page 221: Chapter 22 Battery
Battery Chapter 22 Battery 22.1 Overview The monitor is equipped with a built-in rechargeable battery. When the AC power supply is connected the battery can be charged automatically until full regardless of whether the device is turned on or not. In the event of unexpected power outage the system will automatically use the battery to supply voltage, thus avoiding interruption of device operation. -
Page 222: Installing The Battery
Battery 22.2 Installing the Battery The Monitor's battery must be installed and replaced by trained and authorized maintenance personnel. The battery is not installed when the Monitor leaves the factory. Please contact a maintenance engineer for battery installation before using the Monitor for the first time. WARNING ... -
Page 223: Battery Recycling
Battery must be performed every three months. When you suspect a battery fault, you will also need to perform a battery performance check. Section 22.4.1 Optimize Battery Performance” For the battery performance check procedure, see steps 1 to 4 in “ The length of discharge time reflects the performance of the battery. - Page 224 Battery Blank Page 22-4...
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Page 225: Chapter 23 Cleaning And Disinfection
Please keep the device and its accessories dust free. After cleaning, please check the device carefully. If there is any evidence of ageing or damage, please stop using it immediately. If it is necessary to send back the device to Comen for repair, first clean it. -
Page 226: Cleaning Of The Monitor, Plug-In Modules
Cleaning and Disinfection containing acetone). In order to prevent the entry of cleaning solution and dust into the ISA gas analyzer via the LEGI port, the Nomoline sampling line should always be connected when cleaning the ISA analyzer. Never soak the ISA sidestream gas analyzer in any liquid for disinfection. -
Page 227: Disinfection Of The Monitor, Plug-In Modules
Cleaning and Disinfection 23.3 Disinfection of the Monitor, Plug-in Modules The device, Plug-in Modules are disinfected only when it is considered necessary in the hospital’s maintenance plan. Please clean them before disinfection. Recommended disinfectants are as follows: OPA (5.5g/L), 70% isopropanol, 70% n-propanol, 2% glutaraldehyde, 3% hydrogen peroxide, 0.5% sodium hypochlorite solution. -
Page 228: Cleaning And Disinfection Of Other Accessories
Detergent ECG cable, Temperature sensor, IBP cable extender, CO extended cable, C.O. cable, Water, alcohol (75%) and O cable Comen SpO , Masimo SpO and Nellcor Water, alcohol (75%) sensor and cable extender Water, alcohol (75%) NIBP pneumatic tubing 23.4.2.2 Disinfection Disinfection steps: 1) Dampen a soft cloth with disinfectant and wipe the accessories. -
Page 229: Sterilization
3% hydrogen peroxide, 0.5% sodium extended cable, C.O. cable, and O cable hypochlorite solution. OPA (5.5g/L), 70% isopropanol, 70% n-propanol, 2% Comen SpO , Masimo SpO and Nellcor SpO glutaraldehyde, 3% hydrogen peroxide, 0.5% sodium sensor and cable extender hypochlorite solution OPA (5.5g/L), 70% isopropanol, 70% n-propanol, 3%... -
Page 230: Chapter 24 Maintenance
Upon request by the user, Comen will conditionally provide relevant circuit diagrams to help the user to repair user - serviceable components of the device by appropriate and qualified technicians. -
Page 231: Maintenance Plan
Maintenance 24.2 Maintenance Plan The following tasks can be fulfilled only by professional maintenance personnel recognized by the Company. If the following maintenance is required, please timely contact the maintenance personnel. Prior to test or maintenance, the device must be cleaned and disinfected. Test and Maintenance Items Frequency Visual inspection and performance inspection... -
Page 232: Service Life Of Reusable Accessories
Maintenance 24.3 Service life of Reusable accessories Name Service life ECG lead cable Two years Comen SpO sensor Two years Nellcor/Masimo SpO sensor 6 months Reusable BP cuff 18 months TEMP sensor Two years module, CO sensor,AG module 5 years C.O. -
Page 233: Startup Inspection
Maintenance No dirt on the outer shell of the device; no crack or damage on the panel or screen. The power cord is not worn out and has a good insulation performance. The connector, plug and cable are not damaged or entangled. ... -
Page 234: Nibp Leakage Test
Maintenance 24.6 NIBP leakage test The test is used to ensure the airtightness of the NIBP gas circuit by detecting whether the NIBP measurement pump is leaking. The NIBP leakage test should be performed once every two years or if the NIBP readings seem to be incorrect. -
Page 235: Chapter 25 Other Functions
Chapter 25 Other functions 25.1 Network connection WARNING Use only secure Local Area Network connection. Make sure your hospital’s firewall software is configured correctly, thus blocking incoming connection requests from the Internet. Improper use of network connection may cause virus infections of the Windows system and eventually malfunctions may occur. -
Page 236: Set Network Protocol
25.1.4 Set wireless network Set the network accoding to “ ” or “ ” to connect Central Monitoring Sytem Refer to Comen Central Monitoring System Instructions Manual for detailed function descriptions when the connection to the central monitoring system is established. 25-2... -
Page 237: Connection To The Hospital's Information System By Hl7 Protocol
Other functions NOTE The Net Bed on the monitor must be unique to avoid conflicts with other Net Beds connecting to the central monitoring system. Refer to the instruction manual of our central monitoring system for details. [Time Setup] on the monitor will turn grey and cannot be operated when it is connected to the central monitoring system. -
Page 238: Appendix I Accessories
Appendix I Accessories Here we recommend the following accessories for the Monitor. WARNING In order to avoid damage to the instrument and ensure the safety of the patient, please use accessories specified in this manual or conforming to relevant standards. ... - Page 239 Accessories A4020-EE0 ECG lead A600C-EK2D ECG lead A6196-EL1 ECG lead A6096-EL1 ECG lead CM-M01-001 ECG lead Shenzhen Comen Medical Instruments Co., Ltd. CM-M01-002 ECG lead CM-M01-003 ECG lead CM-M01-004 ECG lead CM-M01-005 ECG lead CM-M01-006 ECG lead CM-M01-007 ECG lead...
- Page 240 Accessories accessories Comen SpO Specifications Models Part body Intended patient Remarks applied population Comen SpO2 cable Reusable SLZ122 extender Comen SpO2 Finger Adult Reusable probe (Adult use, SAL104 finger clip type) Comen SpO2 Finger Adult Reusable probe (Adult use, SAS104...
- Page 241 Accessories Comen SpO2 CM-M02-009 Finger Adult Reusable probe (Adult use, finger wrap type) Comen SpO2 CM-M02-010 Finger Pediatric Reusable probe (Pediatric use, finger wrap type) Comen SpO2 CM-M02-011 Finger Pediatric Reusable probe (Pediatric use, finger wrap type) Comen SpO2 CM-M02-012...
- Page 242 Co. Ltd. Temp sensor /Neonate/ intracavity TPE03-01 Temp sensor /Neonate / body surface TPS03-01 Temp sensor/Adult/Pediatric/body surface TAS03-09 Shenzhen Comen Medical Temp sensor/reusable / body surface CM-M03-001 Instruments Co., Ltd. Temp sensor/reusable / intracavity CM-M03-002 Temp sensor/disposable / body surface...
- Page 243 Blood pressure cuff for infants, 10-19cm, reusable CM-M04-006 Blood pressure cuff for infants, 7-13cm, reusable CM-M04-007 Blood pressure cuff for adults, 46-66cm, reusable Shenzhen Comen Medical CM-M04-008 Instruments Co., Ltd. Blood pressure cuff for adults, 33-47cm, reusable CM-M04-009 Blood pressure cuff for adults, 33-47cm, reusable...
- Page 244 Accessories Blood pressure cuff for neonates, 3.1-5.7cm, CM-M04-015 disposable Blood pressure cuff for neonates, 4.3-8.0cm, CM-M04-016 disposable Blood pressure cuff for neonates, 5.8-10.9cm, CM-M04-017 disposable Blood pressure cuff for neonates, 7.1-13.1cm, CM-M04-018 disposable Blood pressure cuff for neonates, 8.0-15.0cm, CM-M04-019 disposable IBP accessories Description...
- Page 245 Sidestream CO /AG Sampling tube 3837 Sidestream CO /AG Sampling tube 3838 Sidestream CO /AG Sampling tube 3839 Comen mainstream CO module M-01 Shenzhen Comen Medical Instruments Co., Ltd. Comen sidestream CO module F-02 Respironics Novametrix LLC Respironics mainstream CO...
- Page 246 Accessories Sampling tube 1103414 Sampling tube 1103415 C.O. accessories Description Models Manufacturer Shenzhen LAUNCH Electrical C.O. cable CM10-2P4-L30 Co. Ltd.
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Page 247: Appendix Ii Product Specifications
Appendix II Product Specifications 1) Monitor Type Classified by Type Protection against electric Class I; defibrillation-proof devices with internal power supply; shock Degree of protection against Defibrillation-proof type CF: ECG/RESP, TEMP, SpO , NIBP, IBP, C.O.; electrical shock Defibrillation-proof type BF: CO Operation mode Continuous operation equipment. - Page 248 1 (lowest level): a) Single battery (10.8V 5000mAh ): N10/N10A/N10C: no less than 6 hours, N12/N12A/N12C/N15/N15A/N15C: no less than 4.5 hours Battery operation time b) Single battery (10.8V 2500mAh ):...
- Page 249 Product Specifications Memory card—standard capacity： Trend data 120h NIBP measurement 1000 groups Alarm Event 1000 groups Waveform length Arrhythmia Statistics OxyCRG events 400 events 12-lead ECG analysis 20 groups ST review 120h Memory card—large capacity： Trend data 240h NIBP measurement 3500 groups Alarm Event 2500 groups...
- Page 250 Product Specifications interval range Width range (ADU) 70ms~120ms Width range (NEO/PED) 40ms~120ms a) Signals with amplitude (p-v RTI) ≤ 0.15mV No response for the signals (except PED mode); below: b) Signals with 1mV amplitude and 10ms width (except NEO/PED mode). 200µV (lead II) Trigger amplitude Power frequency tolerance...
- Page 251 Product Specifications c) In Surgery mode: >106dB; d) In ST mode: >106dB. Recovery time after reset Drift rate within 10s 10µV/s Baseline control and stability Baseline drift within 1h No more than 500µV Baseline drift under normal No more than 50µV/°C operating temperature a) Power frequency interference rejection ≥...
- Page 252 Product Specifications Extreme Tachy: 60 bpm～300 bpm Extreme Brady: 15bpm～120 bpm Step 1 bpm for the range of 15bpm~40bpm, 5 bpm for 41bpm～300bpm 1.2mV Tall T-wave rejection As required in Section 201.7.9.2.9.101 b) 3) of IEC 60601-2-27, the average HR is calculated as follows.
- Page 253 When the HR rate is consistent with RESP rate, the monitor should generate an (CVA) Identification alarm and display a corresponding alarm message. 9) SpO specifications Comen, Masimo and Nellcor SpO module Name Specification Meets the requirements of ISO 80601-2-61:2017 Displayed measurements Pulse waveform;...
- Page 254 Perfusion Index (PI) 0.05% - 9.99%, resolution: 0.01%, 10.0% - 20.0%, resolution: 0.1%. Masimo SpO 0.02% - 9.99%, resolution: 0.01%. 10.0% - 20.0%, resolution: 0.1%. Signal IQ (SIQ) indicator Masimo SpO and Comen SpO modules have the SIQ feature. II-8...
- Page 255 Product Specifications 10) PR specifications Item Specification Comen SpO Measurement range: 20bpm-300bpm; resolution: 1bpm; measurement error: ±2bpm. Masimo SpO Measurement range: 25bpm-240bpm; resolution: 1bpm; measurement error: ±3bpm (non-motion) or ±5bpm (during motion). Nellcor SpO Measurement range: 20bpm-300bpm;...
- Page 256 Product Specifications 12) CO Specifications Name Specification Meets the requirements of ISO 80601-2-55:2018 Measurement Infrared radiation absorption characteristics method Displayed measurements waveform; EtCO /Fi CO , respiratory rate (awRR) Masimo EtCO module (Mainstream) Masimo EtCO module(Sidestream) EtCO Measurement 0 - 190mmHg / 0 - 25.3 kPa / 0 - 0 - 190mmHg / 0 - 25.3 kPa/ 0 - 25.0% (at range 25.0% (at 760mmHg)
- Page 257 O (non-condensing) (95 %RH at 30 ° C); (95 %RH at 30 °C); Comen/Respironics EtCO (Mainstream) Comen/Respironics EtCO (Sidestream) 0 - 150 mmHg /0% - 19.7%/ Comen: 0 - 150 mmHg: Measurement Range 0 - 20.0kPa (at 760mmHg) 0% - 19.7%: 0 - 20.0kPa (at 760mmHg) II-11...
- Page 258 Sampling Rate 50 ml/min Sampling rate accuracy ±10 ml/min Data sampling rate 100Hz Comen sidestream: Less than 3 seconds (with dehumidification and extension tubing). Respironics CapnoTrak sidestream: Less than 5 Total system response <60 ms seconds (with dehumidification and extension time tubing).
- Page 259 Lower limit: 0mmHg ~ (upper limit - 2mmHg). Step: 1mmHg Upper limit: 0mmHg ~ 76mmHg; lower limit: N/A FiCO alarm limit setting Step: 1mmHg Comen: 0 - 150rpm awRR measurement Comen: 0 - 150rpm Respironics: 0rpm, 2rpm range...
- Page 260 Product Specifications Systole pressure (SYS), Diastolic pressure (DIA), Mean pressure (MAP) Displayed measurement Pulse Rate (PR) in NIBP list COMEN NIBP 25mmHg - 290mmHg (3.33kPa-38.7kPa) Measurement 10mmHg - 250mmHg (1.3kPa-33.3kPa) range in ADU mode 15mmHg - 260mmHg (2.0kPa-34.7kPa) 25mmHg - 250mmHg (3.33kPa-33.3kPa) Measurement 10mmHg - 200mmHg (1.3kPa-28.0kPa)
- Page 261 Product Specifications Upper limit set range: 27mmHg - 285mmHg Lower limit set range: 26mmHg - 280mmHg Extreme low limit set range: 25mmHg - 275mmHg Extreme high limit set range: 13mmHg - 250mmHg Upper limit set range: 12mmHg - 245mmHg Lower limit set range: 11mmHg - 240mmHg Extreme low limit set range: 10mmHg - 235mmHg Extreme high limit set range: 18mmHg - 260mmHg Upper limit set range: 17mmHg - 255mmHg...
- Page 262 Product Specifications Extreme low limit set range: 15mmHg - 110mmHg Manual, auto (periodic), sequence, hourly and continuous mode 1min, 2min, 2.5min, 3min, 4 min, 5 min, 10 min, Measuring interval in 15 min, 30 min, 60 min, 90min, 120 min, 180 min, 240 Blood measurement mode auto mode min, 480 min, 720min...
- Page 263 Product Specifications a) 4 types of alarm limits, including extreme high limit, upper limit, lower limit, and extreme low limit. b) Step: 20mmHg - 50mmHg: 1mmHg. 50mmHg - 260mmHg: 5mmHg Extreme high limit set range: 43mmHg - 260mmHg Upper limit set range: 42mmHg - 255mmHg Lower limit set range: 41mmHg - 250mmHg Extreme low limit set range: 40mmHg - 245mmHg Extreme high limit set range: 23mmHg - 200mmHg...
- Page 264 Product Specifications Upper limit set range: 22mmHg - 95mmHg Lower limit set range: 21mmHg - 90mmHg Extreme low limit set range: 20mmHg - 85mmHg Extreme high limit set range: 29mmHg - 110mmHg Upper limit set range: 28mmHg - 105mmHg Lower limit set range: 27mmHg - 100mmHg Extreme low limit set range: 26mmHg - 95mmHg Manual, auto (periodic), sequence, hourly 1min, 2min, 2.5min, 3min, 4 min, 5 min, 10 min,...
- Page 265 Product Specifications ±1mmHg or ±2%, whichever is greater (sensor error excluded); the accuracy of CPP: Pressure measurement not defined. accuracy ± 4 % of reading or ± 0,5 kPa (± 4 mmHg), whichever is greater (combined effects of sensitivity, repeatability, non-linearity, drift and hysteresis of transducer sensor) Alarm limit rules: a) ART has four alarm limits, namely Extreme upper limit, Upper limit, Lower limit and Extreme Lower Limit, while other pressure has two, namely Upper limit and...
- Page 266 Product Specifications BT upper limit (lower limit+0.1)-43.0°C BT Alarm limits BT lower limit 23.0-(upper limit-0.1) °C Resolution 0.1°C 16) Alarm system Name Specification The alarm system meets the requirements of IEC 60601-1-8. II-20...
- Page 267 Appendix III System Alarm Messages Here we list some of the most important physiological and technical alarm messages. If the problem still exists after you implement the relevant solution provided below, please contact our maintenance engineers. Technical alarm types: A fully clearable, B the alarm sound and light are clearable or C Not clearable. The level of each technical alarm is not adjustable (Except for ECG and SpO 1) Physiological Alarm Messages: 1.1) General Physiological Alarm...
- Page 268 System Alarm Messages Vent Rhythm Pauses/min Too High VT>2 Heart Pause Pacer Not Capture Prompt Pacer Not Pacing Prompt Missed Beats Prompt Couplet Prompt Prompt A-Fib Prompt Irr Rhythm Prompt Irr Rhythm End Prompt A-Fib End Prompt 1.3) ECG Physiological Alarm Alarm Message Alarm Level Cause...
- Page 269 System Alarm Messages 1.5) SpO Physiological Alarm Alarm Message Alarm Level Cause Solution Check the patient's condition. The value of patient’s SpO Confirm that the patient type Extreme Low High below the alarm lower limit. and alarm limits are appropriate to the patient.
- Page 270 System Alarm Messages lead wires well connected. 2) Technical Alarm Major technical alarms are listed here, including their alarm levels, methods of alarm clearing, and the corresponding causes and solutions. Technical alarms respond differently when the alarm system is reset. For easy clarification, in this section the technical alarms are classified into three categories of response when the alarm system is reset: Fully clearable: the technical alarms will be completely cleared.
- Page 271 System Alarm Messages The alarm sound he ECG lead wire is not ECG Lead Off High/Med/Low light or poorly connected clearable Check the connection of ECG electrodes, lead wire Electrode is not or The alarm sound poorly connected to or cable wires. ECG XX Lead Off High/Med/Low light...
- Page 272 System Alarm Messages /SpO the manufacturer for Fully clearable Sensor Off The SpO sensor is maintenance. /SpO b Low connected unreliably. Not clearable Signal If system resetting fails, or the error still exists There is a NELLCOR /SpO bNellco after you restart the Not clearable module error.
- Page 273 System Alarm Messages Ensure the cable is well /SpO The Power cable is not connnected; if the error Fully clearable Cable connected. still exists, please replace the sensor. /SpO An incompatible cable Not clearable Incompatible cable is used. /SpO An unknown cable is Not clearable Check the cable, and Unknown Cable...
- Page 274 System Alarm Messages It needs to check the Please check Check SpO /SpO Not clearable connection connection Sensor Connection /SpO _2 sensor. /SpO _2 sensor. /SpO _2 Sensor /SpO Prompt Initializing Sensor Initializing prompted. Only SpO /SpO Only SpO /SpO _2 is Not clearable Reliable...
- Page 275 System Alarm Messages NIBP cuff is poorly Cuff Inflation Tube connected, or a leak Fully clearable Leak exists in the NIBP gas circuit. An error occurs during measuring the curve, and the system cannot Air Pressure Error Fully clearable perform measurement analysis calculation.
- Page 276 System Alarm Messages connection of each part or replace the cuff with a new one. If the error still exists, contact manufacturer maintenance. Check whether blockage exists in the gas An illegal reset is circuit; then remeasure NIBP Reset Error Fully clearable performed during the it.
- Page 277 System Alarm Messages Alarm Clearance Alarm Message Alarm Level Cause Solution Mode work mode is Set CO work mode to Standby Prompt standby measuring mode. Contact Span Not clearable Span Calibrating. manufacturer Calibrating... maintenance. Check and replace the sampling line; if the error Sampling Line Sampling Line...
- Page 278 System Alarm Messages 1. Confirm the current ambient baropressure does not exceed the environmental specifications required The ambient pressure by this monitor, and exceeds the allowed Atm Pressure the baropressure is not Not clearable module working Overrange affected by external pressure range or the interference sources.
- Page 279 System Alarm Messages The monitor and C.O. It may be disturbed by Sensor should not be CO Baseline Big high-frequency placed in close proximity Not clearable Noise electrosurgical high-frequency equipment. electrosurgical equipment. Cool down the injection in a proper way. For injection example, place...
- Page 280 System Alarm Messages Alarm Clearance Alarm Message Alarm Priority Possible cause Solution Mode and the viewed bed is disrupted. The connection between monitor Viewed by XX YY- Check the network Fully clearable being viewed and the ZZ, disconnected connection. primary monitor is disrupted.
- Page 281 System Alarm Messages 2.12) Technical Alarms of Printer Alarm Message Alarm Priority Alarm Clearance Possible cause Solution Mode Printer No The printer is not Check the printer is Prompt Connected properly connected. correctly connected. The printer has no No Paper Prompt Load the printer paper.
- Page 282 Appendix IV Default configuration information Parameters Settings ECG default settings Name Default setting Filter Monitor QRS Volume Alarm Source Auto Lead Set Auto ECG1 ECG2 (5-Lead, 6-Lead, 12- Lead) Notch Filter Weak Waveform Speed 25 mm/s ECG Gain ECG2 Gain Alarm On/Off Alarm Auto Print Alarm Level...
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Page 283: Appendix Iv Default Configuration Information
Default configuration information Arrhythmia default settings Arrhythmia Alarm default settings Name Alarm Alarm Level Alarm Outputs R on T Bigeminy Trigeminy Nonsus V-Tach Vent Rhythm PVCs/min High Asystole High V-Fib/V-Tach High V-Tach High Vent Brady High Extreme Tachy High Extreme Brady High Run PVCs Couplet... - Page 284 Default configuration information Tachy (The HR upper limit) (bpm) Brady (The HR lower limit) (bpm) Ventricular bradycardia Rate (bpm) Ventricular bradycardia PVCs V-Tac Rate (bpm) V-Tac PVCs Multi PVCs Window PVCs/min A-Fib/Irr Rhy End Time (s) Pauses/min ST default settings Name Default settings ST Alarm Mode...
- Page 285 Default configuration information Show Markers ST Point J+60ms ST Point Adjustment ISO Point -80ms J Point 48ms QT/QTc default settings Name Default settings Alarm On/Off ADU: 500 Alarm Upper Limit (ms) PED: 480 NEO: 460 Alarm Level Alarm Auto Print Alarm On/Off Alarm Upper Limit (ms) Alarm Level...
- Page 286 Default configuration information default settings Masimo, Nellcor and Comen SpO Name Default settings Alarm On/Off ADU: 90-100 Alarm Limits (%SpO PED: 90-100 NEO: 90-100 Alarm Level Alarm Auto Print Alarm On/Off Alarm Lower Limit (%) Alarm Level High Desat Alarm Auto Print Masimo SpO : ADU/PED: normal;...
- Page 287 Default configuration information Alarm Level Alarm Auto Print Alarm On/Off ADU: 50-90 Alarm Limits (mmHg) PED: 40-70 NEO: 30-60 Alarm Level NIBP-D Alarm Auto Print Alarm On/Off ADU: 60-110 Alarm Limits (mmHg) PED: 50-90 NEO: 35-70 Alarm Level NIBP-M Alarm Auto Print Alarm On/Off ADU: 75-175 Alarm Limits (mmHg)
- Page 288 Default configuration information Measurement Times Phase C Measurement Interval Measurement Times STAT Phase D Measurement Interval 1.5h Measurement Times Phase E Measurement Interval 1.5h TEMT default settings Name Default settings Alarm On/Off Alarm Limits (°C) 36.0-39.0 Alarm Level Alarm Auto Print Alarm On/Off Alarm Limits (°C) 36.0-39.0...
- Page 289 Work Mode Measurement Compensation (Respironics/Comen) Compensation (Masimo) O Compensation (Masimo) Waveform Speed 6.25mm/s Scale Waveform Type Line Balance gas (Comen/ Respironics) Room air Altitude unit Altitude(Comen, Respironics) Barometric Pressure 760mmHg 10. IBP default settings Name Default settings Alarm On/Off Art/AO/UAP/BAP/FAP/LV/P1-P4...
- Page 290 Default configuration information ADU: 0-20; PED: 12-26; NEO: 12-26 CVP/ICP/RAP/LAP/UVP/P1-P4 venous pressure: ADU: 0-10; PED: 0-4 NEO: 0-4 Alarm Level Alarm Auto Print Alarm On/Off ADU: 75-175 Alarm Limits (mmHg) PED: 60-130 NEO: 50-95 Alarm Level High Art-S Extreme Alarm Auto Print Alarm On/Off ADU: 35-105 Alarm Limits (mmHg)
- Page 291 Default configuration information 11. C.O. default settings Name Default settings Alarm On/Off Lower/Upper Alarm Limits (°C) 36/39 Alarm Level Alarm Outputs C.O. Coefficient 0.542 Injection temperature (°C) Inject Volume (ml) Interval time (s) Auto Measure Auto T1 C.O. Timeout 15min General Settings Alarm Name...
- Page 292 Default configuration information Alarm Delay Lethal Arrythmia Alarm Off Disabled Desat. Alm Off Disabled Apnea Alarm Off Disabled Intubation Mode Duration 2min Print Option Printer Review Name Default settings Review window duration Channel of waveform Tubular trend time setting 5 min Screen Setup Name Default settings...
- Page 293 Default configuration information Printer Type Printer IP Address 200.200.200.200 Paper Size Manage Name Default settings Department General monitoring Default configuration Load the Latest Configuration Time Name Default settings Date YYYY-MM-DD Time 12-hour IV-12...
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Page 294: Appendix V Emc
Appendix V EMC NOTE The monitor N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C complies with the applicable EMC requirements in IEC 60601-1-2:2014, IEC 60601-2-25:2011, IEC 60601-2-27:2011, IEC 80601-2-30:2018, IEC 60601-2-34:2011, ISO 80601-2-55:2018, ISO 80601-2-56:2017+A1:2018, ISO 80601-2-61:2017. Please follow the EMC instructions in the User’s Manual to install and use the Monitor. - Page 295 Name Cable length (m) With shielding ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable...
- Page 296 Name Cable length (m) With shielding ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable ECG Cable Temp sensor cable Temp sensor cable Temp sensor cable Temp sensor cable Temp sensor cable...
- Page 297 Braun Invasive Pressure Cable BD invasive pressure cable CO2 module cable CO2 module cable CO2 module cable CO2 module cable Comen mainstream CO2 module cable Comen sidestream CO2 module cable C.O. (cardiac output) adapting cable Power Cable Ground cable Essential Performance Under the normal condition or single fault condition, the monitor provided the essential performance listed below, or their failure is readily identifiable by the user.
- Page 298 4. Pulse Rate Measurement Accuracy; 5. Body Temperature Measurement Accuracy; 6. NIBP Measurement Accuracy; 7. IBP Measurement Accuracy; 8. EtCO Measurement Accuracy; 9. C.O. Measurement Accuracy;...
- Page 299 Guidance and manufacturer’s declaration –electromagnetic emission N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C monitor is intended for use in the electromagnetic environment specified below. The customer or the user of NC8/NC8A/NC10/NC10A/NC12/NC12Amonitor should assure that it is used in such an environment. Electromagnetic environment - guidance Emissions test...
- Page 300 AC voltage when the test voltage is not applied yet. Guide and Manufacturer’s Statement – Electromagnetic Immunity N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C monitor is intended for use in the electromagnetic environment specified below. The customer or the user of NC8/NC8A/NC10/NC10A/NC12/NC12Amonitor should assure that it is used in such an environment.
- Page 301 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) The field intensity of fixed RF transmitters measured surveying...
- Page 302 0.01 0.12 0.12 0.23 0.73 0.38 0.38 In case of any maximum rated output power other than listed above, use the formula (“ ” refers to the transmitter’s maximum rated output power (W) learnt from the transmitter manufacturer) in the relevant transmitter frequency column to calculate the recommended isolation distance “d”...
- Page 303 Note * - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal. V-10...
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Page 304: Appendix Vi Glasgow 12-Lead Ecg Analysis
Appendix VI Glasgow 12-Lead ECG Analysis VI.1 Wave measurement From the 12 average beats, a single combined function is formed and a provisional overall QRS onset and termination is determined by thresholding techniques. The provisional onset and termination are then used as starting points for a search for QRS onset and termination within each individual lead. -
Page 305: Vi.2 St Segment And Amplitude Measurement
VI.2 ST Segment and Amplitude Measurement ST segment (Figure 4) shows the ST onset as used in the diagnosis of ST elevation myocardial infarction. However, measurements are also made at equal intervals throughout the ST segment. Figure 4 ST segment P and T waves A search for the P wave is made in the interval preceding the QRS complex. -
Page 306: Vi.3 Interval Measurements
VI.3 Interval Measurements With respect to intervals, the global QT interval is measured from the global QRS onset to the global T end. On the other hand, because the P onset is taken as being simultaneous in all 12 leads, the global PR interval measurement is from the P onset to the global QRS onset. -
Page 307: Vi.5 Analyzing Electrocardiograph Intended Use
QT-interval High-frequency -0.7 3.38 QT-interval Line-frequency (50Hz) -2.4 4.57 QT-interval Line-frequency (60Hz) -2.7 6.58 QT-interval Baseline 8.24 VI.5 Analyzing Electrocardiograph Intended Use Diagnostic application The Glasgow Program is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether this be in a hospital or primary care setting.
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