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i n d u s t r i e s
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About this Manual P/N: 01.54.458083 MPN: 01.54.458083013 Release Date: April, 2020 © Copyright EDAN INSTRUMENTS, INC. 2018-2020. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
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Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
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Table of Contents Chapter 1 Intended Use and Safety Guidance ................................................................................ 1 1.1 Intended Use/Indications for Use ........................................................................................... 1 1.2 Safety Guidance ..................................................................................................................... 1 1.3 Explanation of Symbols on the Monitor .......................................................
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3.11 Using the Barcode Scanner ................................................................................................ 23 Chapter 4 Networked Monitoring .................................................................................................. 24 4.1 Cybersecurity Measures ....................................................................................................... 24 4.1.1 Personal Information Safety.................................................................................
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8.3 Changing Waveform Position .............................................................................................. 60 8.4 Changing Interface Layout ................................................................................................... 60 8.5 Viewing Trend Screen .......................................................................................................... 60 8.6 Viewing OxyCRG Screen .........................................................................................
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9.8.4 Adjusting ST and ISO Measurement Points.............................................................. 80 9.8.5 ST Alarm Setup ......................................................................................................... 80 9.8.6 ST View ..................................................................................................................... 81 9.9 Arrhythmia Monitoring ........................................................................................................ 81 9.
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12.4 Selecting the Active Alarm Source .................................................................................... 99 Chapter 13 Monitoring NIBP ....................................................................................................... 100 13.1 Overview .......................................................................................................................... 100 13.2 NIBP Safety Information ................................................................................
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16.2 CO2 Safety Information ................................................................................................... 116 16.3 Monitoring Procedures ..................................................................................................... 117 16.3.1 Zeroing the Sensor ................................................................................................ 117 16.3.2 Sidestream CO2 Module........................................................................................
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20.4.1 Calculation Procedure ........................................................................................... 136 20.4.2 Input Parameters.................................................................................................... 136 20.4.3 Output Parameters ................................................................................................. 136 20.5 Renal Function Calculation ..............................................................................................
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25.4 Checking Battery Performance ........................................................................................ 153 25.5 Recycling the Battery ....................................................................................................... 153 25.6 Maintaining the Battery.................................................................................................... 154 Chapter 26 Care and Cleaning ........................................................................................
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A.5 RESP ................................................................................................................................. 182 A.6 NIBP .................................................................................................................................. 182 A.7 SpO2 .................................................................................................................................. 184 A.8 TEMP ........................................................................
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Patient Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use/Indications for Use The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.
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Patient Monitor User Manual Intended Use and Safety Guidance WARNING 11 Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.
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Patient Monitor User Manual Intended Use and Safety Guidance WARNING 21 Wireless LAN equipment contains an intentional RF radiator that has the potential of interfering with other medical equipment, including patient implanted devices. Be sure to perform the electromagnetic compatibility test, before installation and any time new medical equipment is added to the Wireless LAN coverage area. 22 The device and accessories are to be disposed of according to local regulations after their useful lives.
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Patient Monitor User Manual Intended Use and Safety Guidance WARNING 38 Connecting any accessory (such as external printer) or other device (such as the computer) to this monitor makes a medical system.
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Patient Monitor User Manual Intended Use and Safety Guidance WARNING 49 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the monitor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Patient Monitor User Manual Intended Use and Safety Guidance 3 Position the device in a location where the operator can easily see the screen and access the operating controls. 4 If the monitor gets damp or liquid pours on the monitor, please contact the service personnel of EDAN. 5 The pictures and interfaces in this manual are for reference only. 6 Regular preventive maintenance should be carried out every two years. You are responsible for any requirements specific to your country.
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Patient Monitor User Manual Intended Use and Safety Guidance 12 Trend 13 Screen or video image, freeze 14 Menu 15 Video output 16 Defibrillator synchronization/Signal output port 17 Output 18 Date of manufacture 19 MANUFACTURER 20 Part Number 21 General symbol for recovery/recyclable 22 Disposal method 23 Operating instructions 24 Refer to instruction manual/ booklet (Background: Blue; Symbol: White) 25 Warning (Background: Yellow; Symbol & outline: black) 26 Gas inlet 27 Ga
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Patient Monitor User Manual Non-ionizing electromagnetic radiation 30 31 Intended Use and Safety Guidance Contains FCC ID Federal Communications Commission: Contains FCC ID: SMQ9113EDAN 32 Do not reuse 33 This way up 34 Fragile, handle with care 35 Keep dry 36 Stacking limit by number 37 Handle with care 38 Do not step on 39 CE marking 40 AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY 41 Use-by date NOTE: The user manual is printed in black and white.
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Patient Monitor User Manual Installation Chapter 2 Installation NOTE: The monitor settings must be configured by the authorized hospital personnel. 2.1 Initial Inspection Before unpacking, check the packaging and ensure that there are no signs of mishandling or damage. If the shipping cartons are damaged, contact the carrier for compensation and package them again. Open the package carefully and remove the monitor and accessories.
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Patient Monitor User Manual Installation NOTE: 1 Check all the functions of the monitor and make sure that the monitor is in good status. 2 If rechargeable batteries are provided, charge them after using the device every time, to ensure the electric power is enough. 3 After long-time continuous running, please restart the monitor to ensure the monitor’s steady performance and long lifespan. 2.
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Patient Monitor User Manual Installation interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: 1. Reorient or relocate the receiving antenna. 2. Increase the separation between the equipment and receiver. 3.
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Patient Monitor User Manual Basic Operation Chapter 3 Basic Operation This manual is for clinical professionals using the X8 X10 and X12 patient monitors. Unless otherwise specified, the information here is valid for all the above products. This user manual describes all features and options. Your monitor may not have all of them; they are not all available in all geographies. Your monitor is highly configurable.
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Patient Monitor User Manual Basic Operation 3 Power supply switch — when the monitor is connected to the AC power supply, press the key to turn the monitor on. When the monitor is turned on, press the key to turn the monitor off. 4 Battery indicator, refer to Section Battery Power Indicator for details. 5 Alternating current indicator— On: AC power is connected; Off: AC power is not connected. 6 Mute — Press it to suspend the output of all audible alarm signals.
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Patient Monitor User Manual Basic Operation 1 Accessory storage area: the accessories can be wrapped around this area to prevent the patient from being entangled or suffocated. 2 Handle: for lifting or moving the monitor, which is convenient, comfortable and fast. 3 Heat sink: Adopt No-fan design, which is dust-free, low noise and low consumption.
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Patient Monitor User Manual Basic Operation indications are alerted through the nurse call system if configured to do so. Analog output: the monitor outputs the waveform through the port. Defibrillator synchronization: the monitor outputs the defibrillator synchronization signal through the port.
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Patient Monitor User Manual 1 2 3 Basic Operation 4 5 6 17 7 16 15 14 1 Department 2 Bed number 3 Patient name 4 Patient type 5 Alarm area 6 Alarm off 7 Measurement value 8 Menu 9 Date and time 10 Scroll right to display more shortcut keys 11 Networking symbol 12 Battery status symbol - 16 - 13 12 11 10 9 8
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Patient Monitor User Manual Basic Operation 13 AC power supply symbol 14 Shortcut key area 15 Scroll left to display more shortcut keys 16 Alarm reset key 17 Parameter waveform 3.2.1 Using Keys The monitor has four different types of keys. If the key sound is enabled, the monitor gives a normal key sound when the operation is valid. 3.2.1.1 Permanent Keys A permanent key is a graphical key that remains on the screen all the time to give you fast access to functions.
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Patient Monitor User Manual Basic Operation Review the alarm event Alarm setup Access the NIBP review Change the beat volume Access the ARR review Enter standby mode Switch to the trend screen Enter night mode Switch to the vital screen Select this item by the rotary knob to enable the touch screen operation Printer Setup Enter warning score interface Enter privacy mode Start/stop recording Freeze or unfreeze waveforms Audio alarm paused/off Start or stop NIBP measurement 3.2.1.
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Patient Monitor User Manual Basic Operation WARNING Demo Mode is for demonstration purposes only. You must not change into Demo Mode during monitoring. In Demo Mode, all stored trend information is deleted from the monitor’s memory. 3.3.2 Standby Mode To enter into standby mode, select Menu > Common Function > Standby, or press the shortcut on the screen directly, the monitor enters into standby mode after user’s confirmation. key In standby mode: 1.
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Patient Monitor User Manual Basic Operation 3.3.4 Privacy Mode Only if the monitor is connected and admitted by MFM-CMS, the privacy mode can be activated. To enter into privacy mode, you can select Menu > Maintenance > User Maintain > Shortcut Setup > Privacy Mode (it is defaulted to be off). Press the shortcut key monitor enters into privacy mode after user’s confirmation. on the screen, the In privacy mode: 1.
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Patient Monitor User Manual Basic Operation automatically resume the NFC mode. After exiting NFC mode: 1. The HR physiological alarms are still on and can be set to off by the user. 2. Pause Time keeps no change and the user can set it to Permanent. 3. Symbol gets disappeared. 3.4 Changing Monitor Settings 3.4.1 Adjusting Screen Brightness To change the screen brightness: 1. Select the shortcut key on the screen directly, or 2.
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Patient Monitor User Manual Basic Operation 3.5.3 Adjusting Beat Volume Beat volume is from HR or PR, depending on your setting of the beat source. To change the beat volume: on the screen directly, or 1. Select the shortcut key 2. Select ECG Setup > Beat Volume, then select the appropriate setting for the beat volume: five bars represent the maximum volume and one bar represents the minimum volume. If none of bars are selected, the beat volume will be off.
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Patient Monitor User Manual Basic Operation calibration interface. 2 In the screen calibration interface, the screen turns gray and no measurement data can be displayed. 3.10 Disabling the Touch Screen The user can disable touch screen operation by selecting and holding the permanent key for three seconds. A message of Screen Locked and the symbol bottom of screen. To enable the touch screen operation, select the symbol will be displayed at the by using the knob. 3.
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Patient Monitor User Manual Networked Monitoring Chapter 4 Networked Monitoring Your monitor can be connected to the wired network and the wireless network. If the monitor is networked, a network symbol is displayed on the screen. NOTE: 1 Be aware that some network-based functions may be limited for monitors on wireless networks in comparison to those on wired networks. 2 When selecting dynamic IP mode, please check the IP address from MFM-CMS. 4.1 Cybersecurity Measures 4.1.
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Patient Monitor User Manual Networked Monitoring CAUTION 6 Anti-virus measures such as USB device virus scanning should be carried out prior to using USB flash drive. 7 Firewalls and/or other security devices should be in place between the medical system and any externally accessible systems. It’s recommended to use Windows defender firewall or any other firewall that can defend against DoS and DDoS attacks, and keep it up to date.
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Patient Monitor User Manual Networked Monitoring When it is set to On, the monitor can enter the normal working interface after start-up; when it is set to Off, after start-up, a password window will be displayed, and the monitor can enter the normal working interface until correct password is input. Default setting is On.  Select the minutes in User login Timeout. If there are no any operations to the monitor for XX minutes (5, 15, 30, 60 and Never), the screen will enter into the screensaver status.
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Patient Monitor User Manual Networked Monitoring 4. Choose a network from the window, in which the user can check the network’s encryption information (Security). The user will be prompted to enter the password of that network if a password is required. After entering the password and setting the IPv4 address, the user can to connect the network. click 5. Or select to connect the hidden networks. After entering Network Name, Security, to connect the hidden network.
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Patient Monitor User Manual Networked Monitoring fails to be connected, please try to restart the monitor and connect again. 4 Use the wireless device recommended by EDAN, otherwise some exceptional situations such as frequent network disconnection may occur on the monitor. 5 The wireless driver is compatible with channels 1-11 only. 6 When signal intensity is level 2 or less, signal may be unstable and quality of the signal transmission may be degraded.
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Patient Monitor User Manual Networked Monitoring monitoring system in the operating room because the ESU will interfere with a wireless network, which may cause networking failure. 2 Make sure the network connection between the monitor and MFM-CMS is in good condition when the time synchronization function on the monitor is active. (Default setting is on. Setting path: Menu > Maintenance > User Maintain > Date/Time Setup > Sync Time).
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Patient Monitor User Manual Alarms Chapter 5 Alarms WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room. 5.1 Alarm Category The monitor provides two types of alarms: physiological alarms and technical alarms. Also, the monitor provides prompts. 5.1.
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Patient Monitor User Manual Alarms 1. High level alarms A high level alarm intensively warns the operator of a high priority alarm condition which requires immediate operator response. Failure to respond to the cause of the alarm condition is likely to result in death or irreversible injury of the patient. 2. Medium level alarms A medium level alarm warns the operator of a medium priority alarm condition which requires prompt operator response.
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Patient Monitor User Manual Alarm Level Low Alarms Prompt Mode is “Di-”, which is triggered once every 30 seconds. When physiological alarm is triggered, the alarm indicator is constantly yellow. While for technical alarm, the alarm indicator is constantly blue. The alarm message flashes with yellow background, and the symbol * is displayed at the alarm area. The sound pressure range for standard audible alarm signals is from 45 dB to 85 dB, and for Mode 1 is from 30 dB to 85 dB.
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Patient Monitor User Manual Alarms corresponding parameter area. Upper arrow or lower arrow to increase or decrease the alarm limit Setting value of high alarm limit Adjustable range Setting value of low alarm limit WARNING 1 When the alarm is set to Off, the monitor won’t give an alarm prompt even if an alarm occurs. In order to avoid endangering the patient’s life, the user should use this function cautiously.
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Patient Monitor User Manual Alarms  The monitor displays the audio alarm paused icon .  The monitor displays the remaining pause time in seconds with red background. When the alarm pause time expires, the audio alarm paused status is automatically terminated and alarm is sounding. You can also terminate the alarm paused status by pressing the hardkey on the front panel or pressing shortcut key on the screen.
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Patient Monitor User Manual Alarms 5.5 Latching Alarms To configure the alarm latching setting, select Menu > Maintenance > User Maintain > Alarm Setup and choose Alarm Latch which can be set to On or Off. When it is set to Off, alarm indications end when the alarm condition ends. When it is set to On, the visual alarm indication and audio alarm indication are still displayed after the alarm condition ends; meanwhile, the alarm time is also displayed for the latched alarm for your reference.
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Patient Monitor User Manual Alarm Information Chapter 6 Alarm Information 6.1 Physiological Alarm Information WARNING Physiological alarms including Asystole, RESP APNEA, SpO2 No Pulse, SpO2 Desat, and CO2 APNEA cannot be turned off. Message Cause Alarm Level HR High HR measuring value is above the upper alarm limit. User-selectable HR Low HR measuring value is below the lower alarm limit. User-selectable ST-X High ST measuring value is above the upper alarm limit.
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Patient Monitor User Manual Message Alarm Information Cause Alarm Level not No pace pulse detected in 1.75 times RR interval after a QRS complex. Pacer Pacing User-selectable Adult: RR interval for 5 consecutive QRS complex ≤ 0.5 s. User-selectable Tachy Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≤ 0.375 s. Adult: RR interval for 5 consecutive QRS complex ≥ 1.5 s. User-selectable Brady Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≥ 1 s.
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Patient Monitor User Manual Alarm Information Message Cause Alarm Level Pauses/min High The measurement value of Pause/min is greater than high alarm limit that has been set. User-selectable PVCs High The measurement value of PVCs is greater than high alarm limit that has been set. User-selectable VEB The delayed ventricular beats detected in normal heartbeats occur more than or equal to 2 times within 30 s.
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Patient Monitor User Manual Alarm Information Message Cause Alarm Level PR Low PR measuring value is below lower alarm limit. User-selectable TEMP T1 High Measuring value of T1 channel is above upper alarm User-selectable limit. T1 Low Measuring value of T1 channel is below lower alarm User-selectable limit. T2 High Measuring value of T2 channel is above upper alarm User-selectable limit. T2 Low Measuring value of T2 channel is below lower alarm User-selectable limit.
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Patient Monitor User Manual Alarm Information Message Cause Alarm Level PA DIA Low PA DIA measuring value is below lower alarm limit. User-selectable PA MAP High PA MAP measuring value is above upper alarm limit. User-selectable PA MAP Low PA MAP measuring value is below lower alarm limit. User-selectable CVP MAP High CVP MAP measuring value is above upper alarm limit. User-selectable CVP MAP Low CVP MAP measuring value is below lower alarm limit.
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Patient Monitor User Manual Message Alarm Information Cause Alarm Level TB High TB measuring value is above upper alarm. User-selectable TB Low TB measuring value is below lower alarm. User-selectable C.O. 6.2 Technical Alarm Information NOTE: The ECG alarm information listed in the below table describes the electrode names in America. For the corresponding electrode names in Europe, please refer to the Section Installing Electrodes.
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Patient Monitor User Manual Alarm Information Message Cause ECG V2 Lead Off ECG electrode V2 falls off the skin or the ECG cable V2 falls off. Low ECG V3 Lead Off ECG electrode V3 falls off the skin or the ECG cable V3 falls off. Low ECG V4 Lead Off ECG electrode V4 falls off the skin or the ECG cable V4 falls off. Low ECG V5 Lead Off ECG electrode V5 falls off the skin or the ECG cable V5 falls off. Low ECG V6 Lead Off ECG electrode V6 falls off the skin or the ECG cable V6 falls off.
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Patient Monitor User Manual Message Cause RR measuring value is out of the measure range. RR Exceed RESP Artifact Alarm Information No RESP waveform can be Cardiac detected due to apnea or shallow breathing of the patient. Alarm Level Action Taken Medium Check whether interference to the respiratory signal exists. And check whether the patient is breathing normally; breathing too rapidly or too slowly may endanger patient’s life. High Check whether the patient is breathing normally.
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Patient Monitor User Manual Alarm Information Message Cause SpO2 Sensor Err Malfunction in the SpO2 sensor or in the extension cable. SpO2 No Sensor No SpO2 sensor was connected to the monitor. SpO2 Low Perfusion The pulse signal is too weak or the perfusion of the measurement site is too low. The SpO2 value and PR value might be inaccurate then. SpO2 Noisy Signal There is interference with SpO2 measurement signals due to patient movement, ambient light, electrical interference or else.
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Patient Monitor User Manual Message Alarm Information Cause Alarm Level NIBP pump, valve, cuff or Low tube has a leakage. NIBP Leak Excessive Pressure has exceeded the specified upper safety limit. Low NIBP Init Pressure High The initial pressure is too high during measuring Low NIBP Aux Excessive Pressure Pressure has exceeded the second safety limit as specified. NIBP Time Out Measuring time has exceeded the specified time.
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Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken NIBP Loose Cuff Cuff is not properly wrapped or no cuff is connected. Low Properly wrap the cuff. NIBP Weak Signal Cuff is too loose or patient pulse is too weak. Low NIBP Exceeded All of SYS, DIA and MAP values are beyond the measurement range. High Range SYS(NIBP) Overrange SYS (NIBP) value is beyond the measurement range. High DIA(NIBP) Overrange DIA (NIBP) value is beyond the measurement range.
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Patient Monitor User Manual Message Alarm Information Cause Alarm Level Action Taken Stop measuring function of TEMP module, and notify biomedical engineer or Manufacturer’s service staff. TEMP Comm Fail TEMP module failure or communication failure. High T1 Failed Calibration T1 calibration failed. High T2 Failed Calibration T2 calibration failed High Please check whether the module works properly.
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Patient Monitor User Manual Message Alarm Information Cause or Alarm Level Action Taken High Stop measuring of C.O. module, or notify biomedical engineer or Manufacturer’s service staff. C.O. Comm Fail C.O. module failure communication failure C.O. TEMP Out Of Range TI/TB measuring value is beyond measuring range. High Please check TI/TB sensor. CO2 Comm Fail CO2 module failure communication failure High Check if the water tray has been fixed.
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Patient Monitor User Manual Message Alarm Information Cause Battery failure or temperature protection Battery Error high Alarm Level Action Taken Low Replace the battery and restart the monitor. Or suspend charging until the battery cools and then continue charging. If the problem still exists, contact your service personnel. Battery Current Too The battery current is too Low High high.
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Patient Monitor User Manual Message Alarm Information Cause Alarm Level Action Taken 1) Check if the network cable is well connected. Network Disconnect Low 3) Check if the IP of bedside monitor and MFM-CMS are on the same network segment. High Stop using the monitor and notify the manufacturer’s service staff. traffic Abnormal network traffic has been detected. The data traffic High exceeds the limit.
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Patient Monitor User Manual Alarm Information Message Cause V-Fib/V-Tach Off V-Fib/V-Tach alarm is set to Off. ExtremeTachy Off Extreme Tachycardia alarm is set to Off. ExtremeBrady Off Extreme Bradycardia alarm is set to Off. Key ARR Alarm Off One of Key ARR alarms is set to Off. Electrode Contact Poor The electrode has bad contact with patient’s body.
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Patient Monitor User Manual Alarm Information Message Cause Venipuncture Ending Finish the assisting venipuncture and the cuff begins to deflate. NIBP Simul NIBP Simul function is turned on. Be sure the cuff is disconnected In Cleaning Mode, the user clicks the Start Cleaning button. from monitor Cleaning succeeded Cleaning finished successfully. Cleaning failed Abnormal air pressure in cleaning mode. Cleaning in progress The monitor is in cleaning progress.
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Patient Monitor User Manual Alarm Information Message Cause Unable to Calibrate in Demo Mode Perform calibration in Demo Mode. Calibrating... Calibration is in progress. C.O. Lack Param Parameter is not configured for C.O. measurement. Warm-up over The monitor displays this message after taking the sensor out of the bracket and warm-up is over. Measure over After the Predict measuring is over, the data and message display on the interface.
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Patient Monitor User Manual Alarm Information QTc and ΔQTc alarm limits are listed as follows: unit (ms) Adjustable Range QTc 200~800 ΔQTc 30~200 RESP alarm limits are listed as follows: unit (rpm) Patient Type Adjustable Range ADU 6~120 PED/ NEO 6~150 SpO2 alarm limits are listed as follows (unit %): Adjustable Range SpO2 20~100 SpO2 Desat Limits are listed as follows (unit %): Adjustable Range SpO2 Desat Limit 20~99 NOTE: User can set the range through User Maintain > Alarm Setup > SpO2 De
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Patient Monitor User Manual Alarm Information TEMP alarm limits are listed as follows: Adjustable Range T1 T2 TD 0 C (32 F)~50 C (122 F) 0 C (32 F)~50 C (122 F) High limit: 0.1 C (32.18 F)~50 C (122 F) IBP alarm limits are listed as follows: unit (mmHg) Adjustable Range 0~300 -10~40 -6~120 -50~300 Art RAP, LAP, CVP, ICP PA P1, P2 CO2 alarm limits are listed as follows: EtCO2 FiCO2 AwRR Adjustable Range 0 mmHg~150 mmHg High limit: 3 mmHg~50 mmHg 2 rpm~150 rpm C.O.
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Patient Monitor User Manual Managing Patients Chapter 7 Managing Patients 7.1 Confirming a Patient After the user switches the monitor on, the monitor will prompt “Continue monitoring the current patient or admit new patient?”. Select Current Patient to use the current configuration; Select New Patient to admit new patient. NOTE: If the user does not make a selection within 1 minute, Current Patient is selected by default. 7.
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Patient Monitor User Manual Managing Patients  Height: Enter the patient’s height, with unit: cm or inch.  Weight: Enter the patient’s weight, with unit: kg or lb. NOTE: 1 Creating new patient and updating patient will clear the history data in the monitor associated with the patient. 2 For Bed No., user can select English, Chinese, Russian through switching keyboard language, and select special characters through . 7.2.
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Patient Monitor User Manual Managing Patients To admit a patient by barcode, 1. The user can scan the barcode through scanner, then a message is displayed to ask the user to confirm the patient update. 2. Click No to cancel this operation; click Yes, the Patient Info window is displayed and the corresponding patient information is updated according to the identified MRN.
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Patient Monitor User Manual 3. Managing Patients Select a patient from the patient list, and click Admit. The corresponding patient information in the monitor will be updated after user’s confirmation. Click View to display the detailed patient information. NOTE: The user can load patient information from the network server only when ADT Query is enabled. Default setting is off. Setting path: Maintenance > User Maintain > Network Maintain > ADT Query.
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Patient Monitor User Manual User Interface Chapter 8 User Interface 8.1 Setting Interface Style The user can set the interface based on the requirement, and the set options include the following:  Sweep of the waveform.  Parameters needing to be monitored. Changing some settings may have the risk, so only the authorized person can change them. After changing the settings, please notify the operator. 8.
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Patient Monitor User Manual User Interface Select short trend to open Short Trend Setup menu, the user can set: 1. Parameter. 2. Interval: set the interval to 30 min, 1 h and 2 h. 8.6 Viewing OxyCRG Screen To view the OxyCRG screen, the user can press the shortcut key on the screen directly or select Menu > Display Setup > View Selection > OxyCRG. This interface is always used in NICU because the SpO2, HR and Resp of the neonate are different from those of adults.
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Patient Monitor User Manual User Interface 8.8 Viewing the Vital Screen To view the vital screen, the user can press the shortcut key select Menu > Display Setup > View Selection > Vital. on the screen directly or 8.9 Viewing the Bed View Window The Bed View window allows you to view one waveform, numeric information of all parameters and alarm information from another bed on the same network. The monitor enables a maximum of eight beds to be viewed.
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Patient Monitor User Manual User Interface 8.9.1 Opening the Bed View Window Before opening the Bed View window, make sure the bed view function is configured on your monitor. To open the Bed View window, select Menu > Display Setup and choose Bed View in the View Selection list. 8.9.2 Settings of the Bed View Window Click on the Bed View window to open the ViewBed Setup menu on which you can  Assign a bed to be viewed by selecting the bed No. in the Bed No. list.
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Patient Monitor User Manual User Interface NOTE: 1 2 The user cannot change timer settings when a timer is running. Do not use the timer to schedule critical patient-related tasks. 3 The timer function is not available in privacy mode and standby mode. 8.12 Profile Select Menu > Maintenance > User Maintain > Profile, enter the required password, users can save the current monitor’s configuration, delete the saved user configuration and rename it.
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Patient Monitor User Manual Monitoring ECG Chapter 9 Monitoring ECG 9.1 Overview The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric. This chapter also tells you about arrhythmia monitoring and ST monitoring. 9.2 ECG Safety Information WARNING 1 Only use the ECG electrodes supplied by the manufacturer when using the monitor for ECG monitoring.
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Patient Monitor User Manual Monitoring ECG WARNING 13 According to AAMI specifications the peak of the synchronized defibrillator discharge should be delivered within 60 ms of the peak of the R wave. The synchronization pulse output on the patient monitors is delayed by a maximum of 35 ms from the R wave peak. Your biomedical engineer should verify that your ECG/Defibrillator combination does not exceed the recommended maximum delay of 60 ms.
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Patient Monitor User Manual Monitoring ECG 9.3 ECG Display The figure below is for reference only. ③ ② ① The symbol “①”indicates lead name of display waveform: there are other leads for selection, such as I, II, III, aVR, aVF, aVL, V (for 5 Electrodes). If you want to change the lead, please refer to Section Selecting Calculation Lead. The symbol “②” indicates Filter setting, there are six options: Monitor, Surgery, Diagnosis, Enhanced, Diagnosis 1, and Customized.
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Patient Monitor User Manual Monitoring ECG 9.3.2 Changing the ECG Filter Settings The ECG filter setting defines how ECG waves are smoothed. An abbreviation indicating the filter type is shown underneath the lead label on the monitor display. Filter settings do not affect ST measurement. To change the filter setting, in the ECG Setup menu, select Filter and then select the appropriate setting. – Monitor: Use this mode under normal measurement conditions.
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Patient Monitor User Manual Monitoring ECG pace pulses.  The QRS should be tall and narrow.  The P-waves and the T-waves should be less than 0.2 mV. NOTE: Make sure you have selected the best lead with the best waveform amplitude and highest signal-to-noise ratio. Choosing the best lead is important for heart beat test, heart beat classification and ventricular fibrillation detection. 9.5 Monitoring Procedure 9.5.
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Patient Monitor User Manual Monitoring ECG 9.5.4 Installing Electrodes NOTE: The following table gives the corresponding electrodes names used in Europe and America respectively. (Electrodes names are represented by R, L, F, N, C, C1-C6 in Europe, whose corresponding electrodes names in America are RA, LA, LL, RL, V, V1-V6.
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Patient Monitor User Manual Monitoring ECG 5 Electrodes Placement Take the American standard for example, see the following figure: ■ RA placement: directly below the clavicle and near the right shoulder. ■ LA placement: directly below the clavicle and near the left shoulder. ■ RL placement: on the right hypogastrium. ■ LL placement: on the left hypogastrium. ■ V placement: on the chest, the position depends on your required lead selection.
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Patient Monitor User Manual Monitoring ECG V-Electrode Placement for 5 Electrodes 6 Electrodes Placement For the placement of 6 electrodes, please use the position of 5 electrodes in the schematic diagram to remove the two thoracic leads. The two thoracic leads Va and Vb can be placed at any two positions from V1 to V6, as shown in the following thoracic leads. To ensure that the label is correct, the selected Va and Vb placements must be set simultaneously in ECG Setup.
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Patient Monitor User Manual Monitoring ECG ■ RL placement: on the right hypogastrium. ■ V1: On the 4th intercostal space at the right sterna margin. ■ V2: On the 4th intercostal space at the left sterna margin. ■ V3: Midway between V2 and V4 electrodes. ■ V4: On the 5th intercostal space at the left clavicular line. ■ V5: On the left anterior axillary line, horizontal with V4 electrode. ■ V6: On the left middle axillary line, horizontal with V4 electrode.
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Patient Monitor User Manual Monitoring ECG WARNING ECG cables can be damaged when connected to a patient during defibrillation or using other high frequency equipment. Check cables for functionality before using them again. It is recommended to use defibrillator-proof ECG lead to avoid burn. NOTE: 1 If an ECG waveform is not accurate, while the electrodes are tightly attached, try to change the leads displayed on the screen.
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Patient Monitor User Manual  Monitoring ECG a PR source is switched on and available. If an ECG lead becomes available again, the monitor automatically uses HR as beat source and displaying in the HR parameter box the monitor gives a “Di” tone with a blinking heart when one heartbeat is detected. While a pulse is detected, the monitor gives a “Da” tone. 9.6.
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Patient Monitor User Manual Monitoring ECG default, Vb is Lead V5 by default. 4 If AUTO is selected in the ECG Setup menu, when the electrodes connected to patient is reduced from 10 electrodes to 3/5/6 electrodes, user can click Update Lead Setup button to enable the monitor to perform lead off alarm according to actual electrodes. 5 If AUTO is selected in the ECG Setup menu, Va and Vb cannot be set when the monitor recognizes the 10 electrodes system automatically.
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Patient Monitor User Manual Monitoring ECG NOTE: The patients can’t be monitored during ECG calibration. 9.6.7 ECG Waveform Settings To change this speed, select ECG Waveform Setup > Sweep, then select an appropriate setting from the pop-up list. The bigger the value is, the wider the waveform is. Select ECG Waveform Setup > Cascade: Turn on or off ECG cascade. Cascade means the ECG waveforms displayed on the screen all occupy the area of two waveforms.
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Patient Monitor User Manual Monitoring ECG automatic analysis function. To perform 12-lead analysis: 1. In the ECG Setup menu, set Electrode Type to 10 Electrodes and set Screen Layout to 12 Leads. 2. Select the shortcut key 3. The analysis results will be provided in the Analysis Review window after approximately 10 seconds. on the screen directly.
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Patient Monitor User Manual Monitoring ECG main screen. NOTE: 1 ST-segment analysis is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. For this reason, the recommended and default setting for ST analysis in neonatal and pediatric modes is Off. 2 In ST analysis, the obtained ST value and ST template are all unaffected by the selected filter mode.
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Patient Monitor User Manual Monitoring ECG 9.8.2 ST Display Your monitor screen may be configured to look slightly different from the illustrations. 9.8.3 About ST Measurement Points The ST value for each beat complex is the vertical difference between the ISO point and the ST point, as shown in the diagram below. The isoelectric (ISO) point provides the baseline, and the ST point is at the midpoint of the ST segment.
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Patient Monitor User Manual Monitoring ECG Differential: The monitor triggers the alarm according to the change of ST. The user does not need to set alarm for each ST separately, but only need to set alarm switch, alarm level and alarm difference value (-0.1~0.1) for all ST. When ST Alarm Mode is differential, the user needs to select Delay to set the ST alarm delay time. 3 seconds and 5 seconds are optional, and the default is 3 seconds.
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Patient Monitor User Manual Monitoring ECG personnel can use arrhythmia analysis to evaluate patient’s condition (such as heart rate, PVCs frequency, rhythm and ectopic beat) and decide the treatment. Besides detecting change of ECG, arrhythmia algorithm can also monitor patients and give proper alarm for arrhythmia.
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Patient Monitor User Manual ARR Alarms Vent Pause Pauses/min High VEB Multiform PVCs Occurring Condition Atrial fibrillation alarm should meet below two conditions for 1 minute: The RR interval of normal beats must be irregular, and it can be seen that the obvious f or P waves do not exist. Afib Acc. Rhythm Monitoring ECG 5 consecutive ventricular beats, and 40 bpm ≤ ventricular HR < 100 bpm. No QRS is detected within the heartbeat pause threshold value that has been set.
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Patient Monitor User Manual Monitoring ECG arrhythmia analysis. If the ECG signal is too small, a false asystole alarm may occur. Aberrantly-Conducted Beats: As not recognizing the P waves, the monitoring system is difficult to distinguish between aberrantly-conducted beats and ventricular heartbeat. If the aberrantly-conducted beat is similar to ventricular tachycardia, it may be classified as ventricular.
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Patient Monitor User Manual      Monitoring ECG Sinus arrhythmia Atrioventricular block Frequent ventricular premature beats Myoelectric interference Electrode motion artifact 9.9.2 ARR Analysis Menu 9.9.2.1 Switching ARR Analysis On and Off To switch ARR Analysis on or off, in the ECG Setup menu, select ARR Analysis to toggle between On and Off from the popup interface. 9.9.2.
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Patient Monitor User Manual Monitoring ECG 9.9.2.3 Adjustable Range of ARR Alarm Threshold ARR Alarm Range PVCs High 1/min to 99/min Pause 2 s, 2.5 s, 3 s ExtremeTachy Adult: 120 bpm to 300 bpm; Pediatric/neonatal: 120 bpm to 350 bpm PAC Bigeminy PAC Trigeminy 3/min to 50/min Pauses/min High 1/min to 20/min Sustain VT 15 s to 45 s ExtremeBrady 15 bpm to 60 bpm Low Voltage(Limb) 0.3 mV to 0.8 mV 9.9.2.
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Patient Monitor User Manual Monitoring ECG 1) Take care that ARR selflearning may start automatically; 2) Response to electrodes off information; 3) Always check the correctness of arrhythmia alarm. 9.10 QT Analysis The QT interval is the time from the beginning of Q wave to the end of T wave. It measured the total duration of the depolarization (QRS duration) and repolarization (ST-T) phases of ventricular action potential. QT analysis can help detect extended QT interval syndrome. 9.10.
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Patient Monitor User Manual Monitoring ECG 9.10.4 Selecting QT Analysis Lead There are two modes for selection: All lead: Use all available leads (expect pressurized the limb lead) to produce an overall QT measurement, user can select ALL through ECG Setup > QT Analysis > Analysis Lead. Single lead: QT measurements were performed using all single leads available in the lead (except the pressurized limb lead). User selects any lead in Analysis Lead menu to enter into single lead mode. 9.10.
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Patient Monitor User Manual Monitoring ECG 9.10.7 QTc Alarm Setup Select ECG Setup > QT Analysis > Alarm Setup to change the following QT alarm settings:  Separately switch on or off QTc alarm and ΔQTc alarm and set the alarm level.  Set the thresholds of QTc alarm and ΔQTc alarm. When QTc value or ΔQTc value exceeds the preset thresholds, an alarm will be triggered. 9.10.8 QT View To enter QT view, please select ECG Setup > QT Analysis > QT View.
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Patient Monitor User Manual Monitoring RESP Chapter 10 Monitoring RESP 10.1 Overview The monitor measures respiration from the amount of thoracic impedance between two ECG electrodes. The change of impedance between the two electrodes, (due to the thoracic movement), produces a respiratory waveform on the screen. 10.
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Patient Monitor User Manual Monitoring RESP WARNING 10 RESP Apnea alarm is based on inadequate thoracic impedance change. 11 When ECG electrode is placed on patient’s limb, the impedance respiration may be unreliable. 12 RESP Apnea alarm should not be used or relied upon while the patient is unattended. NOTE: The RESP monitoring is not recommended to be used on patients who are very active, as this can cause false alarms. 10.
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Patient Monitor User Manual Monitoring RESP may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory wave. NOTE: Place the red and green electrodes diagonally to optimize the respiration waveform. Avoid the liver area and the ventricles of the heart in the line between the RESP electrodes so as to avoid cardiac overlay or artifacts from pulsating blood flow. This is particularly important for neonates. 10.
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Patient Monitor User Manual Monitoring SpO2 Chapter 11 Monitoring SpO2 11.1 Overview SpO2 is used to measure arterial blood oxygen saturation, which is the percentage of oxyhemoglobin in the arterial blood. SpO2 parameter can also provide pulse rate (PR) and a plethysmogram wave (Pleth). 11.2 SpO2 Safety Information WARNING 1 Do not use the SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor.
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Patient Monitor User Manual Monitoring SpO2 2 When a trend toward patient deoxygenation is indicated, analyze the blood samples with a laboratory co-oximeter to completely understand the patient’s condition. 3 SpO2 waveform is not directly proportional to the pulse volume. 4 The device is calibrated to display functional oxygen saturation. 5 A Functional tester or simulator can not be used to assess the SpO 2 accuracy.
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Patient Monitor User Manual Monitoring SpO2 whose hands are unavailable.  Place the finger into the sensor according to the direction of the symbol on the sensor. Adjust the finger to ensure that the pad of the finger completely covers the sensor detection window.  Orient the sensor so that the cable will be running towards the top of the patient’s hand.  Connect the sensor with the monitor (or with the extension cable if needed).
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Patient Monitor User Manual Monitoring SpO2 WARNING Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. For neonate, change the measuring site every 20 minutes. NOTE: 1 Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements.
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Patient Monitor User Manual Monitoring SpO2  a blood pressure cuff is inflated on the same extremity as the one with the sensor attached  there is arterial occlusion proximal to the sensor  low peripheral perfusion NOTE: 1 To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material. 2 Adjacent SpO2 sensors may interfere with each other (eg, multiple SpO 2 measurements in the same patient).
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Patient Monitor User Manual Monitoring SpO2 11.6 SpO2 Alarm Delay There is a delay between a physiological event at the measurement site and the corresponding alarm at the monitor. This delay has two components: 1. The time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing time and the sensitivity setting.
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Patient Monitor User Manual Monitoring PR Chapter 12 Monitoring PR 12.1 Overview The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute (bpm). You can obtain a pulse from any measured SpO2 signal or any arterial pressure. 12.2 Setting PR Source The monitor provides PR source options. You can select SpO2 or arterial pressure labels as the PR source in the PR Source list on the PR Setup menu. 12.
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Patient Monitor User Manual Monitoring NIBP Chapter 13 Monitoring NIBP 13.1 Overview This monitor uses the oscillometric method for measuring NIBP. It can be used for adult, pediatric and neonatal patients. It is also intended for use with pregnant, including pre-eclamptic patients. Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery.
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Patient Monitor User Manual Monitoring NIBP WARNING 11 Continuous cuff pressure due to connection tubing kinking can block the blood flow, and may result in injury to the patient. 12 Verifying the calibration is only applicable for adults, and it cannot be operated in automatic measuring interval. Continuous measuring cannot be operated in automatic measuring interval either.
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Patient Monitor User Manual Monitoring NIBP 13.4 Measurement Methods There are four methods of measuring NIBP:  Manual - measurement on demand.  Auto - continually repeated measurements (between 1 and 480 minute adjustable interval). The interval can be user defined, and the default interval of user defined is 2.5 minutes. After the first measurement starts manually, the monitor will automatically measure NIBP as preset interval.
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Patient Monitor User Manual Monitoring NIBP WARNING Prolonged non-invasive blood pressure measurements in Auto, Continuous or Sequence mode may be associated with purpura, ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed, stop the blood pressure measurements. 13.
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Patient Monitor User Manual 6. Monitoring NIBP Wait until the first reading is taken. NOTE: 1 The width of the cuff is either approximately 40% of the limb circumference or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 80%-100% of the limb. The wrong size of cuff can cause erroneous readings. If the cuff size is in question, use another cuff with suitable size to avoid errors. 2 If an NIBP measurement is suspect, repeat the measurement.
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Patient Monitor User Manual Monitoring NIBP 13.5.2 Correcting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level to the displayed value: Add 0.75 mmHg (0.10 kPa) for each Deduct 0.75 mmHg (0.10 kPa) for each centimeter higher or centimeter lower or Add 1.9 mmHg (0.25 kPa) for each inch Deduct 1.9 mmHg (0.25 kPa) for each inch higher lower 13.
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Patient Monitor User Manual 5. Monitoring NIBP Select Leakage Test. Then the prompt Leak. Test Running will appear indicating that the system has started the leakage test. The system will automatically inflate the pneumatic system to about 180 mmHg. After 20 seconds to 40 seconds, if system leakage has detected, the system will automatically open the deflating valve to stop the leak test and indicates NIBP Leak.
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Patient Monitor User Manual Monitoring NIBP 13.12 Assisting Venipuncture The user can use the NIBP cuff to cause a pressure close to diastolic pressure, so as to block the venous blood vessel and therefore help venipuncture. To assist venipuncture: 1. Select NIBP Setup > Venipuncture; 2. Select the appropriate Cuff Pressure according to the patient type; 3. Select Start, the monitor displays: Venipuncture Starting. 4. Wait until the monitor prompts In venipuncture process.
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Patient Monitor User Manual Monitoring TEMP Chapter 14 Monitoring TEMP 14.1 Overview Body temperature is measured by means of a thermistor probe (a semiconductor whose resistance changes with temperature) that is applied to the skin or to the rectum. Two TEMP probes can be used simultaneously to measure two TEMP values and get the temperature difference. The standard configuration is skin probe for adult. 14.
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Patient Monitor User Manual Monitoring TEMP 14.6 Selecting a Temperature for Monitoring Select the temperature label according to the measurement site. The label is a unique identifier for each type of temperature. To select the label, 1. Click the TEMP parameter area to enter TEMP Setup menu. 2. Select the appropriate label from the list for T1 and T2.
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Patient Monitor User Manual Monitoring IBP Chapter 15 Monitoring IBP 15.1 Overview IBP is measured by means of a catheter inserted directly into the circulatory system. A pressure transducer connected to the catheter converts the mechanical force exerted by the blood into an electrical signal, which is displayed graphically as pressure versus time on a monitor screen or numerically on digital display.
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Patient Monitor User Manual Monitoring IBP 1. Plug the pressure cable into the corresponding socket and switch on the monitor. 2. Prepare the flush solution. 3. Flush through the system, exhaust all air from the tube, and ensure that the transducer and stopcocks are free of air bubbles. 4. Connect the patient catheter to the pressure line, making sure that there is no air present in the catheter or pressure line. 5.
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Patient Monitor User Manual Monitoring IBP  Every time you reconnect the transducer cable to the monitor;  If you think the monitor’s pressure readings are not correct. When using a pressure module, the zero information is stored in the module. The zeroing procedure is listed as below: 1. Turn off the stopcock to the patient. 2. Vent the transducer to atmospheric pressure, to compensate for the static and atmospheric pressure exerted on the transducer. 3.
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Patient Monitor User Manual Monitoring IBP 15.5 IBP Waveform Overlapping The monitor can display IBP overlapped waveforms. To set IBP waveform overlapping: 1. Select Menu > Maintenance > User Maintain > Other Setups, and set IBP Wave Overlapping to On or Off. 2. Click the IBP waveform area to show the IBP Wave Setup menu. 3. Select Add IBP Waves and then select the IBP waves for overlapping from the pop-up list. A maximum of four overlapping waveforms can be displayed. 4.
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Patient Monitor User Manual Monitoring IBP 6. If you need to start a new measurement, select Remeasure. 7. Click on Exit or select Setup > PAWP Exit to exit. WARNING 1 Prolonged inflation can cause pulmonary hemorrhage, infarction or both. Inflate the balloon for the minimum time necessary to get an accurate measurement.
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Patient Monitor User Manual Monitoring IBP 15.8 Calculating PPV Pulse Pressure Variation (PPV) is calculated from the specific arterial pressure values, which reflects the variation between the maximal pulse pressure and the minimum pulse pressure in 30 seconds. Pulse pressure is affected by left ventricular-stroke volume, arterial resistance and arterial compliance. WARNING 1 The clinical value of the derived PPV information must be determined by a physician.
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Patient Monitor User Manual Monitoring CO2 Chapter 16 Monitoring CO2 16.1 Overview The monitor provides the sidestream and mainstream methods for CO2 monitoring. EDAN EtCO2 module is used for sidestream measuring. The principle of CO2 measurement is primarily based on the fact that CO2 molecule can absorb 4.3μm infrared ray. Absorption intensity is proportional to CO2 concentration of patient sample, the CO2 concentration will compute according to the detecting CO2 absorption intensity of patient sample.
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Patient Monitor User Manual Monitoring CO2 WARNING 13 Do not use the EtCO2 monitor for diagnostic purpose. 14 CO2 APNEA alarm is based on prolonged over-the-threshold EtCO2 concentration. 15 CO2 APNEA alarm should not be used or relied upon while the patient is unattended. 16 The EtCO2 reading is not always closely related to the paCO2 value, especially in neonatal patients, and patients with pulmonary disease, with pulmonary embolism or inappropriate ventilation.
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Patient Monitor User Manual Monitoring CO2 2. Connect the sampling cannula or the sampling line to the water trap. 3. Set Work Mode to Measure. 4. For intubated patients, an airway adapter is required. For non-intubated patients, place the nasal cannula or the sampling mask onto the patient. Place the Nasal Cannula CAUTION 1 The water trap collects water drops condensed in the sampling line and therefore prevents them from entering the module.
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Patient Monitor User Manual Monitoring CO2 CAUTION 6 The sample gas flowrate 50 ml/min is only applicable to patients whose respiratory rate ranges from 0 rpm to 40 rpm. NOTE: To avoid patient cross infection, do not connect the exhaust tube to the ventilator circuit. If the sampled gas is returned to the breathing system, always use the bacterial filter of the sample gas return kit. 16.3.2.
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Patient Monitor User Manual Monitoring CO2 WARNING Safety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established. 16.6 Setting CO2 Waveform Open the menu CO2 Waveform Setup by clicking on the CO2 waveform area:  Choose Mode and set it to Curve or Filled from the pop-up list;  Choose Sweep and select a suitable setting from the pop-up list.
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Patient Monitor User Manual Monitoring C.O. Chapter 17 Monitoring C.O. 17.1 Overview The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters by using the Thermodilution method. The Thermodilution method is to inject a cold solution into the blood circulation system and measure the temperature changes caused by the cold solution through the thermistor of the pulmonary artery floating catheter, and the C.O.
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Patient Monitor User Manual Monitoring C.O. 1: Monitor; 2: Thermodilution Catheter; 3: Cardiac Output Cable; 4: Injectate Sensor Housing; 5: Injectate; 6: Delivery System; 7: In-line injectate Temperature probe. C.O. Sensor Connection 3. Open the patient information window to confirm the patients’ height and weight. 4. In C.O. Setup menu, set:  C.O. Constant: The computation constant is associated with catheter and injectate volume. When the catheter is changed, please adjust Constant in the C.O.
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Patient Monitor User Manual Monitoring C.O. 2 3 4 5 6 7 1 8 10 11 9 1 Measurement curve 2 Cardiac Output 3 Cardiac Index 4 Body Surface Area 5 Blood Temperature 6 Injectate Temperature 7 Start time of the measurement 8 Prompt message area 9 Function keys 10 X axis: Change the Scale X (time) value. Two modes are available: 0 s to 30 s, 0 s to 60 s.
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Patient Monitor User Manual Monitoring C.O. the parameter area and the start measurement time (7 in the above figure). To ensure the accuracy of the measurement, it is suggested that a reasonable interval should take place between two consecutive measurements. The length of the interval can be set in the C.O. Setup menu (Time unit: second). The interval time counter is displayed on the screen.
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Patient Monitor User Manual Monitoring C.O. NOTE: 1 The blood temperature alarm will not function during C.O. measurement. It will resume automatically when the measurement is over. 2 It is strongly recommended that the user must push the injector within four seconds after pressing the Start button. 3 It is strongly recommended that you wait at least 1 minute (or longer depending on the patient’s clinical condition) before starting the next measurement. 17.
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Patient Monitor User Manual Freeze Chapter 18 Freeze 18.1 Overview When monitoring a patient, the user may freeze the waveforms and examine them. Generally, the user can review a frozen waveform of a maximum of 120 seconds. The freeze function of this monitor has the following features:  Freeze status can be activated on any operating screen.  Once entering the Freeze status, the system exits all other operating menus.
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Patient Monitor User Manual Review Chapter 19 Review The monitor provides 120-hour trend data of all parameters, storage of 1200 NIBP measurement results, 200 alarm events, 200 arrhythmia events, 24 hours OxyCRG and 50 sets of 12-lead analysis results. This chapter gives detailed instruction for review of all data. 19.1 Trend Graph Review To review the trend graph, please press the Trend Graph key Menu > Review > Trend Graph.
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Patient Monitor User Manual Review  Select beside the parameter name and choose the desired parameter from the pop-up list (as shown in red circle above).  Press the symbols and to switch parameters in batch. ■ Select Zoom to adjust the trend scale. Once the trend scale on the trend graph review interface is adjusted, the trend scale of the corresponding parameter in TrendScreen of the main interface will also change.
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Patient Monitor User Manual Review or select Menu > Review > NIBP Review. In the NIBP review window: ■ Select Unit to change the pressure unit. ■ Select ■ Select Record to print out the NIBP measurement data by the recorder. ■ Select Print to print out the NIBP review report by the printer. and to browse more NIBP measurement data. 19.4 Alarm Review To review the alarm event, please press the Alarm Review key Menu > Review > Alarm Review.
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Patient Monitor User Manual Review Rename for the arrhythmia event. Confirm the changes to make the settings take effect.  Select Delete to remove a specific arrhythmia event.  Select Alarm List or Exit to get back to the arrhythmia review interface. NOTE: 1 If there are more than 200 arrhythmia events, the monitor will only keep the recent ones. 2 The name of arrhythmia event will be shown on the alarm status area.
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Patient Monitor User Manual Calculation Chapter 20 Calculation The monitor provides calculation and record function and titration table. Calculations are patient data that are not directly measured but calculated by the monitor. The monitor can perform drug calculation, hemodynamic calculation, oxygenation calculation, ventilation calculation and renal function calculation, and also support record function. NOTE: 1 The drug calculation function acts only as a calculator.
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Patient Monitor User Manual Calculation 3. The system generates values that can’t be treated the calculation results. The user must enter the correct parameter value based on the doctor’s instruction. 4. Manually enter the value of patient weight or directly obtain the value from the monitor by selecting Get Info. 5. Enter the correct parameter value. 6. Confirm whether the calculation result is correct.
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Patient Monitor User Manual Calculation The data in the titration table will vary with the changes above. And the user can perform the following:  Select  Record the data displayed in the current window by selecting Record. and to observe more data. 20.2 Hemodynamic Calculation 20.2.1 Calculation Procedure 1. The hemodynamic calculation interface is displayed by selecting Menu > Common Function > Calculation > Hemodynamics. 2. Manually enter the values required on this interface.
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Patient Monitor User Manual Items Unit Calculation English Full Name/Description Formula CVP ) / C.O. SVRI DS·m2/cm5 Systemic vascular resistance index SVRI = SVR/ BSA PVR DS/cm5 Pulmonary vascular resistance PVR = 80* ( PA MAPPAWP ) / C.O. PVRI DS·m2/cm5 Pulmonary vascular resistance index PVRI = PVR / BSA LCW kg·m Left cardiac work LCW = 0.0136 * AP MAP* C.O. LCWI g·m Left cardiac work index LCWI= LCW / BSA RCW kg·m Right cardiac work RCW = 0.0136 *PA MAP* C.O.
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Patient Monitor User Manual Calculation Items Unit English Full Name/Description PvO2 mmHg Partial pressure of oxygen in venous blood SvO2 % Venous oxygen saturation Hb g/L Hemoglobin RQ / Respiratory quotient Height cm Height Weight kg CI L/min/m Weight 2 Cardiac index 20.3.3 Output Parameters Items Unit English Full Name/Description Formula BSA m2 BSA=Weight0.425*Height0.725*0.007184 VO2 ml/(min. m2 ) C a-v O2 ml/L O2ER % DO2 PAO2 ml/(min.
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Patient Monitor User Manual CvO2 ml/L Calculation Calculated venous oxygen content CvO2=(Hb)*1.34*SvO2/100%+(0.0031*PvO2) 20.4 Ventilation Calculation 20.4.1 Calculation Procedure 1. Select Menu > Common Function > Calculation > Ventilation. 2. Manually enter the values required on this interface. You can also directly obtain the values of FiO2, RR, PIP and PEEP if they are available from the monitor by selecting Get Info. 3. Select Calculate to output parameter value. 20.4.
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Patient Monitor User Manual Calculation Items Unit English Full Name/Description Formula VD/VT % VD/VT=(PaCO2-PeCO2)/PaCO2 VA L/min Physiological dead space in percent of tidal volume Alveolar volume Cdyn ml/cmH2O Compliance dynamic VA=(VT-VD)*RR/1000 Cdyn=VT/(Ppeak-PEEP-PEEPi) 20.5 Renal Function Calculation 20.5.1 Calculation Procedure 1. Select Menu > Common Function > Calculation > Renal Function. 2. Manually enter the values required on this interface. 3.
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Patient Monitor User Manual Calculation Items Unit English Full Name/Description Formula URKEx mmol/24h URKEx= URK* Urine/1000 Na/K % CNa ml/24h CCr ml/min CUUN ml/min FENa % FEUr % Cosm ml/min CH2O ml/24h U/P osm / Urine potassium excretion Sodium potassium ratio Clearance of sodium Creatinine clearance rate Urine urea nitrogen clearance rate Fractional excretion of sodium Fractional Excretion of Urea Osmolar clearance Free water clearance Urine to plasma osmolality ratio Blood u
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Patient Monitor User Manual Warning-Score System Chapter 21 Warning-Score System User can use warning-score system to get an early warning score based on measurement value or input value of each vital sign. Depending on the score calculated, an action list with appropriate recommendations is displayed. Warning-score system includes NEWS (National Early Warning Score System) and MEWS (Modified Early Warning Score) system.
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Patient Monitor User Manual Warning-Score System 21.3 Warning-Score Criteria In NEWS interface, select Criteria to check score criteria as following: Value 3 2 RESP (rpm) ≤8 SpO2 (%) ≤91 TEMP (℃) ≤35.0 SYS (mmHg) ≤90 HR (bpm) ≤40 92~93 91~100 1 0 1 9~11 12~20 94~95 ≥96 35.1~36.0 36.1~38.0 38.1~39.0 101~110 111~219 41~50 51~90 Consciousness 2 3 21~24 ≥25 ≥39.
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Patient Monitor User Manual Warning-Score System for value and severity level is as following: NEWS Severity Level Color NEWS=0 Non-urgent Green 17 NOTE: The score result can be displayed on the main screen through
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Patient Monitor User Manual Recording Chapter 22 Recording A thermal dot matrix recorder is used for the monitor and can support many recording types and output patient information, measurement data, review data waveform and so forth. 2 1 3 4 4 1 Recording indicator 2 Paper feeding key: press this key to start or stop feeding recording paper without outputting anything on the paper 3 Paper outlet 4 Recorder door 22.1 Performance of the Recorder  Waveform record is printed at the rate of 12.
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Patient Monitor User Manual Recording procedure below: Recording Type Description/ Procedure Continual real-time recording Select at least one Rec waveform in Recorder Setup (A maximum of three waveforms can be selected), select Continual in R-T Rec Time. Press shortcut key on the screen to start the recording. Press the shortcut again to stop recording.
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Patient Monitor User Manual Recording Type Renal Function result recording Recording Description/ Procedure Calculation Select Menu > Common Function > Calculation > Renal Function, click Record to start recording. 12-lead analysis recording Select ECG Setup > 12-L Review, click Record to start recording. C.O. measurement recording Select C.O. Option > C.O. Measure, click Record to start recording. Frozen waveform recording In the Freeze window, click Record to start recording.
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Patient Monitor User Manual Recording 22.3.3 Paper Out When the Recorder Out OF Paper alarm is displayed, the recorder cannot start. Please insert record paper properly. 22.3.4 Replacing Paper 1. Pull outwards the upper arc part of the recorder casing to release the casing, shown in the following figure. 2. Insert a new roll of paper into the paper cassette, printing side facing upwards. 3. Ensure proper position and tidy margin. 4. Pull about 2 cm of the paper out, and close the recorder casing.
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Patient Monitor User Manual Printing Patient Reports Chapter 23 Printing Patient Reports Patient reports can be printed out by an HP series laser printer connected with the monitor. NOTE: Use the printer HP Laser Jet P2055dn, HP LaserJet Pro 400 M401n and HP LaserJet 600 M602, which are tested to be compatible with the monitor. 23.1 Printer Settings You can configure the printer settings on the monitor before printing out patient reports.
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Patient Monitor User Manual Printing Patient Reports Report Type Procedure 12-lead analysis report In the Analysis Review window, click Print to start printing. 12-lead report analysis waveform In the 12-Lead Analysis Waveform Review window, click Print to start printing. Drug calculation titration report In the Titration window, click Print to start printing. Oxygenation calculation report In the Oxygenation window, click Print to start printing.
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Patient Monitor User Manual Other Functions Chapter 24 Other Functions 24.1 Nurse Call The monitor provides dedicated nurse call port which is connected to nurse call system through the nurse call cable to perform the nurse call function. You should activate the function following the steps below: 1. Select Menu > Maintenance > User Maintain, and input the password; 2. Select Other Setups > Aux Output; 3. Choose On in the Nurse Call list.
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Patient Monitor User Manual Other Functions Store and set Threshold Detection to On. When the removable device is newly inserted and selected as storage device, and its remaining storage space is less than 300 M, the monitor will not store data, prompting The space in U disk is less than 300 M. Please clean it up. The user needs to clean up the space manually till the remaining space is more than 300 M, thus the monitor will keep storing data.
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Patient Monitor User Manual Other Functions CAUTION 1 Not all the removable devices are compatible with the monitor, Use the removable devices recommended by EDAN. 2 Do not set the read-only switch on the removable device to on when the removable device is inserted in the monitor. 3 It is recommended to format the USB flash drive to the FAT file type via PC prior to use. 24.3.
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Patient Monitor User Manual Other Functions 24.3.7 Formatting the Internal Storage Device To format the internal storage device, select Menu > Maintenance > User Maintain > Other Setups > Format internal storage device. Further confirmation is required. After Formatting, the monitor displays result including Format Succeeded or Format Failed, Please Retry! NOTE: 1 As soon as the internal storage device is formatted, all the data will be cleared.
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Patient Monitor User Manual Using Battery Chapter 25 Using Battery This monitor can run on battery power, which ensures its uninterrupted operation even when AC power supply is interrupted. The battery recharges whenever the monitor is connected to the AC power source. During monitoring, if the AC power is interrupted, the monitor will take power from the internal battery. If the monitor is powered by battery, the monitor will switch off automatically before the battery is completely depleted. 25.
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Patient Monitor User Manual Using Battery 25.2 Battery Power Indicator The indicator labeled Battery on the front panel of the monitor illuminates in green when the monitor is battery powered and illuminates in yellow when battery is being charged. The indicator is not illuminated when the monitor is not powered or fully powered, or when AC power is applied. 25.3 Battery Status on the Main Screen Battery status symbols show the status of each battery detected and the combined battery power remaining.
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Patient Monitor User Manual Using Battery WARNING Do not disassemble batteries, put them into fire or cause them to short circuit. They may ignite, explode or leak, causing personal injury. 25.6 Maintaining the Battery Batteries should be conditioned regularly to maintain their useful life. Remove the batteries from the monitor if they are not used for a longer period of time. And recharge the batteries to 40%~60% every 6 months when they are stored.
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Patient Monitor User Manual Care and Cleaning Chapter 26 Care and Cleaning Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. EDAN Instruments has validated the cleaning and disinfection instructions included in this User Manual.
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Patient Monitor User Manual Care and Cleaning 26.2.1 Cleaning the Monitor WARNING Before cleaning the monitor, make sure that the monitor is switched off and disconnected from the power line. To surface-clean the monitor, follow these steps: 1. Switch off the monitor and disconnect it from the power line. 2. Wipe the entire exterior surface, including the screen, of the equipment using a soft cloth dampened with the cleaning solution thoroughly until no visible contaminants remain. 3.
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Patient Monitor User Manual Care and Cleaning 2. Thread the hose from within the cuff and out through the small hole at the top of the cuff. 3. Adjust the bladder until it is in position. 26.2.2.3 Cleaning the SpO2 Sensor 1. Wipe the surfaces of the sensor and cable using a soft cloth dampened with the cleaning solution until no visible contaminants remain. 2. Wipe the patient contact area of the sensor with the cotton swab dampened with the cleaning solution until no visible contaminants remain.
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Patient Monitor User Manual Care and Cleaning WARNING The monitor and reusable accessories shall be disinfected to avoid patient cross infection. CAUTION 1 2 Do not use any disinfectant containing additional active ingredients other than those listed, such as disinfectant didecyl dimethyl ammonium bromide which contains quanternary ammonium salt.
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Patient Monitor User Manual Care and Cleaning 2. Wipe the cuff and the air bladder with a soft cloth dampened with the disinfectant solution. 3. Leave the cuff and air bladder to air dry for at least 30 minutes. Replacing the Air Bladder: After disinfection, replace the air bladder into the cuff. Refer to Cleaning the Blood Pressure Cuff for more information. NOTE: Prolonged use of disinfectant may cause discoloration of the cuff. 26.3.2.3 Disinfecting the SpO2 Sensor 1.
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Patient Monitor User Manual Maintenance Chapter 27 Maintenance WARNING 1 Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. 2 If you discover a problem with any of the equipment, contact your service personnel, or your authorized supplier.
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Patient Monitor User Manual Maintenance and Test Schedule Maintenance Frequency Safety checks. Selected tests on At least once every two years, or as needed, after any the basis of IEC60601-1 repairs where the power supply is removed or replaced, or if the monitor has been dropped. Check all monitoring functions At least once every two years, or as needed.
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Patient Monitor User Manual Warranty and Service Chapter 28 Warranty and Service 28.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) damage caused by mishandling during shipping. b) subsequent damage caused by improper use or maintenance. c) damage caused by alteration or repair by anyone not authorized by EDAN.
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Patient Monitor User Manual Accessories Chapter 29 Accessories You can order accessories from EDAN supplies at www.edan.com.cn or consult your local EDAN representative for details. WARNING 1 Never reuse disposable transducers, sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard. 2 Use only EDAN-approved accessories.
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Patient Monitor User Manual Accessories Part Number Accessories 01.57.471227 ECG trunk cable, 5-lead, 12-pin, ESU-proof, AHA/IEC, 5.0 m, reusable 01.57.471228 5-lead, 12-pin, Defib-proof, Adult/pediatric 01.57.471229 5-lead, 12-pin, Defib-proof, Adult/pediatric, Extended 01.13.036620 5-lead, Clip, AHA, Adult/pediatric, Extended 01.13.036621 5-lead, Clip, AHA, Adult/pediatric 01.13.036622 5-lead, Snap, AHA, Adult/pediatric, Extended 01.13.036623 5-lead, Snap, AHA, Adult/pediatric 01.13.
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Patient Monitor User Manual Accessories Part Number Accessories 01.57.471464 ECG limb wires, 3-lead, snap, AHA, 1.0 m, reusable 01.57.471465 5-lead, 12-pin, Defib-proof, Clip, IEC, 3.4 m, Reusable 01.57.471466 5-lead, 12-pin, Defib-proof, Clip, AHA, 3.4 m, Reusable 01.57.471467 5-lead, 12-pin, Defib-proof, Snap, IEC, 3.4 m, Reusable 01.57.471468 5-lead, 12-pin, Defib-proof, Snap, AHA, 3.4 m, Reusable 01.57.471473 5-lead, 12-pin, ESU-proof, Clip, IEC, 3.4 m, Reusable 01.57.
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Patient Monitor User Manual Accessories Part Number Accessories 01.57.471276 Disposable ECG Electrodes 01.57.471056 Disposable ECG Electrodes 01.57.471057 Disposable ECG Electrodes 01.57.471060 Disposable ECG Electrodes 29.2 SpO2 Accessories Part Number Accessories SpO2 Sensor 02.57.225029 7-pin SH1 Adult Reusable SpO2 Sensor /adult, 2.5 m 02.01.210120 SH1 Adult Reusable SpO2 Sensor (DB9) 02.01.210673 SH3 Neonate Wrap SpO2 Sensor 02.01.210122 SH4 Adult Silicone Soft-tip SpO2 Sensor 02.
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Patient Monitor User Manual Accessories Part Number Accessories 01.57.471328 NIBP Cuff, E7, Child, 16-21.5 cm, reusable 01.57.471329 NIBP Cuff, E8, Small adult, 20.5-28 cm, reusable 01.57.471330 NIBP Cuff, E9, Adult, 27-35 cm, reusable 01.57.471331 NIBP Cuff, E10, Large adult, 34-43 cm, reusable 01.57.471396 NIBP Cuff, E11,Thigh, 42-54 cm, reusable 01.57.471323 NIBP Cuff, Neonate, 10 cm-15 cm, reusable 01.57.471324 NIBP Cuff, Neonate, 6 cm-11 cm, reusable 01.57.
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Patient Monitor User Manual Accessories 29.5 IBP Accessories Part Number Accessories IBP Transducer 01.57.471070 IBP Pressure transducer interface cable/Interface model BD 01.57.471172 IBP Pressure transducer interface cable/EDWARD type interface 01.57.471173 IBP Pressure transducer interface cable/Hospira type interface 01.57.471166 IBP Pressure transducer interface cable/the UTAH type interface 01.57.471836 IBP Pressure transducer interface cable/12 pin,B.Braun type interface 01.57.
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Patient Monitor User Manual Accessories Part Number Accessories 01.57.471284 All Purpose Sampling Cannula without filter (Non Sterile). Size: Neonate 01.57.471285 Duo Flow O2+CO2 Sampling Cannula (Non Sterile). Size: Adult 01.57.471286 Duo Flow O2+CO2 Sampling Cannula (Non Sterile). Size: Child 01.57.471287 Capnomask O2+CO2 Sampling Cannula (Non Sterile). Size: Adult 01.57.471288 Capnomask O2+CO2 Sampling Cannula (Non Sterile). Size: Child 29.7 C.O. Accessories* *Only applicable to X12.
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Patient Monitor User Manual Part Number Accessories Accessories 01.13.114214 Ground Cable 01.18.052245 Netac USB flash disk (U208, 4G, USB2.0) 02.01.210633 Unicode recorder, Serial/parallel port 01.17.052452 SD Memory Card (8GB, Class4) 01.21.064380 Rechargeable Lithium-Ion Battery, 2550 mAh, 10.8 V 01.21.064381 Rechargeable Lithium-Ion Battery, 5100 mAh, 10.8 V 02.01.211226 Patient monitor mounting arm assembly kit 02.01.211225 Patient monitor mounting arm assembly kit 02.04.
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Patient Monitor User Manual Product Specification A Product Specification NOTE: The performance of the equipment with ☆ mark is determined to be essential performance. A.1 Classification Anti-electroshock type Class I equipment and internal powered equipment Anti-electroshock degree CF Ingress Protection IPX1 Disinfection/sterilization method Refer to Chapter Care and Cleaning for details.
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Patient Monitor User Manual Product Specification A.2.3 Environment Specification The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges. When the monitor and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products.
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Patient Monitor User Manual Product Specification A.2.5 Battery Specification Operating Time 2550 mAh (standard) ≥4h 5100 mAh (optional) ≥8h Condition At 20 C ~30 C, with (a) new fully charged battery/batteries, continuous SpO2 measurement and NIBP automatic measurement mode at interval of 15 minutes, brightness set to “1”. Charge Time 2550 mAh (standard) ≤ 3.5 h, 90% charge 5100 mAh (optional) ≤ 6.5 h, 90% charge Condition Environment temperature: 20 C ~30 C. And the monitor is off. A.
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Patient Monitor User Manual Product Specification 120 hrs, at 1 min. Resolution Alarm/Monitoring Event data Up to 200 sets NIBP Measurement Review 1200 sets Arrhythmia events Up to 200 sets 12-lead analysis Review Up to 50 sets Refer to Chapter Review for more information about data review.
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Patient Monitor User Manual Product Specification 17 dBm for 802.11b DSSS 17 dBm for 802.11b CCK 17 dBm for 802.11g OFDM 16 dBm for 802.11n OFDM 5 G: 10 dBm for 802.11a OFDM 9 dBm for 802.11n OFDM A.3.2 Wi-Fi Performance Specifications System Capacity and Resistance to When the following conditions are present, Wireless Interference ■ Quantity of the monitors supported by a single AP: ≤ 8. ■ Each monitor can communicate with MFM-CMS.
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Patient Monitor User Manual Product Specification works normally requirements: and meets the following ■ Total delay time for data transmission from the monitors to MFM-CMS: ≤ 2 s. ■ Total delay time of data transmission from one monitor to other monitors: ≤ 2 seconds. ■ Effective time of alarm reset configured on another monitor ≤ 2 s. ■ Effective time for monitor-related settings configured on the MFM-CMS: ≤ 2 s. ■ No communication loss between all the monitors.
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Patient Monitor User Manual Product Specification Electrode Standard AHA, IEC ☆Display Sensitivity (Gain Selection) 1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1), 20 mm/mV (×2), 40 mm/mV (×4), AUTO gain ☆Sweep 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s Bandwidth (-3dB) Diagnosis: 0.05 Hz to 150 Hz Diagnosis 1: 0.05 Hz to 40 Hz Monitor: 0.
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Patient Monitor User Manual ☆Multichannel Crosstalk Product Specification ≤ 5% of the input signal Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.5. ☆Frequency and Impulse Frequency response: Input a 5 Hz, 1 mV sine wave signal, and the output signal Response amplitude remains within the range of 71 % to 110 % at 0.67 Hz and 40 Hz. Input a 1 Hz, 1.5 mV 200 ms triangular wave input signal, and the output shall be within 11.25 mm~15 mm. Impulse response: Displacement value: ≤ 0.1 mV Slope: ≤ 0.
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Patient Monitor User Manual Product Specification Heart Rate HR Calculation ☆Range ADU: 15 bpm to 300 bpm PED/NEO: 15 bpm to 350 bpm ☆Accuracy ±1% or 1 bpm, whichever is greater Resolution 1 bpm Sensitivity ≥ 300 μVPP ☆QRS Detection Range The detection range has exceeded the requirement described in the standard: Width: 70 ms~120 ms for adult, 40 ms~120 ms for Pediatric/neonate. Amplitude: 0.5 mv~5 mv In adult mode, these two signals are not responded: 1. when QRS amplitude of 0.
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Patient Monitor User Manual Product Specification QTc measurement Range 200ms ~ 800 ms Resolution 1 ms ΔQTc measurement Range -600 ms ~ 600 ms Resolution 1 ms HR Averaging Method Method 1 Heart rate is computed by excluding the minimum and maximum values from the 12 most recent RR intervals and averaging the residual 10 RR intervals. Method 2 If each of three consecutive RR intervals is greater than 1200 ms, then the four most recent RR intervals are averaged to compute the HR.
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Patient Monitor User Manual Product Specification Maximum Start-up Alarm Time for Tachycardia Ventricular Tachycardia Gain 0.5: 10 s Gain 1.0: 10 s 1 mV 206 bpm Gain 2.0: 10 s Ventricular Tachycardia Gain 0.5: 10 s Gain 1.0: 10 s 2 mV 195 bpm Gain 2.0: 10 s Response Time of Heart HR range: 80 bpm to 120 bpm Rate Meter to Change in Range : Within 11 s HR HR range: 80 bpm to 40 bpm Range : Within 11 s Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.17 ☆Tall T-wave Rejection minimum recommended 1.
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Patient Monitor User Manual Product Specification PR interval (ms) QRS interval (ms) QT/QTC (ms) P-QRS-T AXIS A.5 RESP Method Impedance between RA-LL, RA-LA Measurement lead Options are lead I and II. The default is Lead II. Calculation Type Manual, Automatic Baseline Impedance Range 200 Ω to 2500 Ω (with ECG cables of 1 KΩ resistance) Measuring Sensitivity Within the baseline impedance range: 0.3 Ω Waveform Bandwidth 0.2 Hz to 2.5 Hz (-3 dB) Respiration Waveform Excitation Sinusoid, 45.
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Patient Monitor User Manual Mode Product Specification Manual, Auto, Continuous, Sequence Measuring Interval in AUTO 1/2/3/4/5/10/15/30/60/90/120/180/240/360/480 Mode (unit: minutes) and User Define Continuous 5 min, interval is 5 s Measuring Parameter SYS, DIA, MAP, PR Pressure Unit kPa, mmHg, cmH2O ☆Measuring Range ☆Adult Mode SYS: 25 mmHg to 290 mmHg DIA: 10 mmHg to 250 mmHg MAP: 15 mmHg to 260 mmHg SYS: 25 mmHg to 240 mmHg DIA: 10 mmHg to 200 mmHg MAP: 15 mmHg to 215 mmHg SYS: 25 mmHg to 140
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Patient Monitor User Manual Product Specification Venipuncture pressure Adult Default: 60 mmHg Options: 20 mmHg, 30 mmHg, 40 mmHg, 50 mmHg, 60 mmHg, 70 mmHg, 80 mmHg, 90 mmHg, 100 mmHg, 110 mmHg, 120 mmHg Pediatric Default: 40 mmHg Options: 20 mmHg, 30 mmHg, 40 mmHg, 50 mmHg, 60 mmHg, 70 mmHg, 80 mmHg Neonatal Default: 30 mmHg Options: 20 mmHg, 30 mmHg, 40 mmHg, 50 mmHg A.7 SpO2 Complies with ISO 80601-2-61: 2017.
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Patient Monitor User Manual Product Specification A.8 TEMP Complies with ISO 80601-2-56: 2018. Technique Thermal resistance Position Skin, oral cavity, rectum Measure Parameter T1, T2, TD (the absolute value of T2 minus T1) Channel X8: 1 X10/X12: 2 Sensor Type YSI-10K and YSI-2.252K Unit C, F Measuring Range 0 C to 50 C (32 ºF to 122 ºF) Resolution 0.1 C (0.1 ºF) ☆Accuracy1 0.
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Patient Monitor User Manual IBP Measure ☆Measuring Range Product Specification Art (0 to +300) mmHg PA/PAWP (-6 to +120) mmHg CVP/RAP/LAP/ICP (-10 to +40) mmHg P1/P2 (-50 to +300) mmHg Resolution 1 mmHg ☆Accuracy (not including sensor)  2 % or 1 mmHg, whichever is greater ICP: 0 mmHg to 40 mmHg:  2 % or 1 mmHg, whichever is greater; -10 mmHg to -1 mmHg: undefined Pressure Unit kPa, mmHg, cmH2O Pressure sensor Sensitivity 5 μV/V/mmHg Impedance Range 300 Ω to 3000 Ω Filter DC~ 12.
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Patient Monitor User Manual Product Specification  2 mmHg, 0 mmHg to 40 mmHg ☆Accuracy EtCO2 Typical conditions:  5% of reading, 41 mmHg to Ambient temperature: (25  3) C 70 mmHg Barometric pressure: (760  10)  8% of reading, 71 mmHg to mmHg Balance gas: N2 100 mmHg Sample gas flowrate: 100 ml/min  10% of reading, 101 mmHg to 150 mmHg ± 12% of reading or ± 4 All conditions mmHg, whichever is greater AwRR  1 rpm Drift of Measure Meets the requirements of the measure accuracy Accuracy Sample Gas
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Patient Monitor User Manual Product Specification Zero Calibration Support Calibration Support (It is recommend to be operated by trained personal.) ☆Alarm EtCO2, FiCO2, AwRR ☆ Apnea delay Data Sample Rate EtCO2 Change1 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s; default value is 20 s.
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Patient Monitor User Manual Product Specification Ethanol 0.1% None Isopropanol 0.1% None Acetone 0.1% None Methane 1% None NOTE: Respiration Rate accuracy was verified by using a solenoid test setup to deliver a square wave of known CO2 concentration to the device. 5% and 10% CO2 concentrations were used. Respiration rate was varied over the range of the device. Pass/Fail criteria was comparison of the respiratory rate output from the sensor to the frequency of the square wave. A.12 C.O.
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Patient Monitor User Manual Product Specification A.13 Interfaces A.13.1 Analog Output (Optional) Bandwidth (-3 dB; frequency: 10 Hz) reference Monitor: 0.5 Hz to 40 Hz Diagnosis/Diagnosis 1: 0.05 Hz to 40 Hz Surgery: 1 Hz to 20 Hz Enhanced: 2 Hz ~18 Hz Customized: When Low-pass Filter < 40 Hz, Bandwidth is High-pass Filter ~ Low-pass Filter; When Low-pass Filter > 40 Hz, Bandwidth is High-pass ~40 Hz.
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Patient Monitor User Manual Product Specification Minimum Required R-wave Amplitude 0.3 mV Pulse Width 100 ms±10% Limited Current 15 mA rating Rising and Falling Time < 1 ms Interface Type PS2 connector A.13.3 Nurse Call (Optional) Drive Mode Voltage output Power Supply ≤ 12.6 VDC, 200 mA Max. Interface Signal 12 V power supply and PWM waveform Interface Type PS2 connector PS2 connector Definition for Analog Output/Defibrillator Synchronization/Nurse Call PIN.NO.
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Patient Monitor User Manual Product Specification A.13.5 VGA Interface (Optional) Number of VGA Interface 1 Horizontal Refreshing Rate (30-94) KHZ Video Signal 0.7 Vpp @ 75 Ohm, HSYNC/VSYNC signal TTL Interface Type DB-15 female receptacle A.13.6 Wired Network Interface Specification 100-Base TX (IEEE802.
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Patient Monitor User Manual EMC Information B EMC Information - Guidance and Manufacture’s Declaration B.1 Electromagnetic Emissions Guidance and manufacture’s declaration – electromagnetic emission X8 X10 and X12 are intended for use in the electromagnetic environment specified below. The customer or the user of X8/X10/X12 should assure that they are used in such an environment.
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Patient Monitor User Manual Immunity test Electrostatic discharge (ESD) EMC Information IEC/EN 60601 test level Compliance level 8 kV contact 8 kV contact 15 kV air 15 kV air IEC/EN 61000-4-2 Electrical fast 2 kV for power supply transient/burst lines 1 kV for line to line IEC/EN 61000-4-5 2 kV for line to ground 1 kV for line to line Mains power quality should be that of a typical commercial or hospital environment. 30 A/m 30 A/m 0 % UT; 0.
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Patient Monitor User Manual EMC Information B.3 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity X8 X10 and X12 are intended for use in the electromagnetic environment specified below. The customer or the user of X8 X10 and X12 should assure that they are used in such an environment.
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Patient Monitor User Manual EMC Information manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
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Patient Monitor User Manual EMC Information Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequenc y (MHz) 385 450 Band a) (MHz) 0.3 27 430-470 GMRS 460, FRS 460 FM c) ±5 kHz deviation 1 kHz sine 2 0.3 28 704-787 LTE Band 13, 17 Pulse modulation b) 217 Hz 0.2 0.3 9 800-960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation b) 18 Hz 2 0.
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Patient Monitor User Manual EMC Information a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) 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. B.
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Patient Monitor User Manual Default Settings C Default Settings This appendix documents the most important default settings of your monitor as it is delivered from the factory. Note: If your monitor has been preconfigured according to your requirements, the settings at delivery will be different from the default settings listed here. C.1 Patient Information Default Settings Patient Information Settings Patient Type Adult Pace Off C.
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Patient Monitor User Manual Alarm Switch Off Alarm Level Medium Alarm Record Off Alarm High Limit (ST-X) 0.2 Alarm Low Limit (ST-X) -0.2 QT Analysis Off QTc 500 ΔQTc 60 Default Settings 480 460 X stands for I, II, III, aVR, aVL, aVF, V, V1, V2, V3, V4, V5 or V6.
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Patient Monitor User Manual Default Settings ExtremeBrady On High (non-adjustable) Off V-Tach On High (non-adjustable) Off Wide QRS Tachy On Medium Off Non-Sustain VT On Medium Off Afib On Medium Off Acc.
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Patient Monitor User Manual Default Settings Alarm Low Limit 8 Apnea delay 20 s Calculation Type Auto Resp Type II Sweep 12.5 mm/s Amplitude 1 8 30 PED NEO C.5 SpO2 Default Settings SpO2 Settings ADU Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 100 100 95 Alarm Low Limit 90 90 88 Pitch Tone On Sweep 12.5 mm/s SpO2 Desat Limit 80% PED NEO C.
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Patient Monitor User Manual Default Settings Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit (SYS) 160 120 90 Alarm Low Limit (SYS) 90 70 40 Alarm High Limit (Map) 110 90 70 Alarm Low Limit (Map) 60 50 30 Alarm High Limit (DIA) 90 70 60 Alarm Low Limit (DIA) 50 40 20 Venipuncture pressure 60 40 30 Inflation value 160 140 100 Unit mmHg Interval Manual PED NEO C.
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Patient Monitor User Manual Filter Default Settings 12.5 Hz SYS, DIA, MAP SYS, DIA, MAP SYS, DIA, MAP Alarm High Limit (ART, P1, P2) 160, 90, 110 120, 70, 90 90, 60, 70 Alarm Low Limit (ART, P1, P2) 90, 50, 70 70, 40, 50 55, 20, 35 Alarm High Limit (PA) 35, 16, 20 60, 4, 26 60, 4, 26 Alarm Low Limit (PA) 10, 0, 0 24, -4, 12 24, -4, 12 MAP MAP MAP Alarm High Limit (CVP, RAP, LAP, ICP) 10 4 4 Alarm Low Limit (CVP, RAP, LAP, ICP) 0 0 0 PED NEO C.
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Patient Monitor User Manual Amplitude Default Settings Low C.11 C.O. Default Settings C.O. Settings ADU Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit (TB) 40.0 Alarm Low Limit (TB) 30.0 Injective Temperature Source Auto Temperature Unit C Interval 30 Constant 0.
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Patient Monitor User Manual Abbreviation D Abbreviations Abbr English Full Name/Description AC Alternating current Acc.
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Patient Monitor User Manual Abbreviation Abbr English Full Name/Description EEC European Economic Community EEG Electroencephalogram EMC Electromagnetic compatibility EMG Electromyelogram EMI Electromagnetic interference Enf Enflurane ER Emergency room ESU Electrosurgical unit Et End-tidal EtCO2 End-tidal carbon dioxide EtN2O End-tidal nitrous oxide Eto Ethylene oxide EtO2 End-tidal oxygen ExtremeTachy Extreme Tachycardia ExtremeBrady Extreme Bradycardia FCC Federal Commun
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Patient Monitor User Manual Abbreviation Abbr English Full Name/Description IEEE Institute of Electrical and Electronic Engineers IPVC Inserted Premature Ventricular Contraction Irr Rhythm Irregular Rhythm Iso Isoflurane LA Left arm LAP Left atrial pressure LCD Liquid crystal display LED Light emitting diode LL Left leg Low Voltage(Limb) Low QRS Voltage MAP Mean arterial pressure MDD Medical Device Directive MetHb Methemoglobin MRI Magnetic resonance imaging Multiform PVCs M
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Patient Monitor User Manual Abbreviation Abbr English Full Name/Description PR Pulse rate PVC Premature ventricular contraction R Right RA Right arm RAP Right atrial pressure Resp Respiration RHb Reduced hemoglobin RL Right leg RM Respiration mechanics RR Respiration Rate Run PVCs Run premature Ventricular Contractions SEF Spectral edge frequency Sev Sevoflurane SpO2 Pulse Oxygen Saturation Sustain VT Sustained Ventricular Tachycardia SQI Signal quality indicator SR Supp
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