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ZONDAN iMD 12 Manual

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Product Information
Product model: iMD 12
Product name: Patient Monitor
Manufacturer
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd.
Registered/Production address:
Floor 14, Block D,Dianlian Technology Building,the Crossing between South Circle
Road and South Fuli Road ,Guangming District,518106 Shenzhen PEOPLE'S
REPUBLIC OF CHINA
Tel: +86 755 26865970
Edition
First Edition: May 2018
MEDHealth supplies (Pty) Ltd
All Rights Reserved.
Distributor
MEDHealth Supplies (Pty) Ltd
Corner of Barbara and North Reef Road
Elandsfontein, Henville, 1429, Germiston, Johannesburg, Gauteng, South Africa
Reg No.: 2021/385832/07
E-mail: admin@medhealthsup.com
Regulatory and Safety Specifications
Standard
The product is made under the ISO13485 quality system certified by TUV PS. The
product has passed the CE certification.
Declaration
The iMD 12 Patient Monitor is a Class IIb device and complies with the requirements of
the Council Directive 93/42/EEC concerning medical devices and carries CE-marking
accordingly.
Authorized EU Representative
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax: +86 755 26860497
Telephone: +27 10 013 3010
Fax: 0049-40-255726
I
Instructions Manual
First Edition: May 2018

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Summary of Contents for ZONDAN iMD 12

  • Page 1 The product is made under the ISO13485 quality system certified by TUV PS. The product has passed the CE certification. Declaration The iMD 12 Patient Monitor is a Class IIb device and complies with the requirements of the Council Directive 93/42/EEC concerning medical devices and carries CE-marking accordingly.
  • Page 2 Explanation of Symbols The following symbols appear on the monitor and its packaging. Table 1 Monitor and Packaging Symbols Symbol Description Symbol Description Caution, consult CE mark accompanying documents 5 5℃ Keep dry Temperature limitations -2 0℃ Atmospheric pressure Humidity limitations limitations Keep upright Fragile, handle with care...
  • Page 3 defibrillation-proof function. Instructions Manual First Edition: May 2018...
  • Page 4 Table 1 Monitor and Packaging Symbols (continue) Symbol Description Symbol Description CF applied part: including F applied part (float/insulation) Ethernet port defibrillation-proof function. Video output Fuse Protective grounding Equipotential grounding Date of manufacture Dangerous Voltage Serial Number Manufacturer address Batch code Configuration number Catalogue number EU representatives...
  • Page 5 Mode of operation Continuous Product Support and Warranty Information The manufacturer warranties the iMD 12 Patient Monitor for one year. Keep the packing case for transport, storage, or maintenance. The manufacturer is responsible for the safety, reliability, and performance of the monitor when the: •...
  • Page 6 Friday (except Chinese statutory holidays) BJT 08:30–12:00, 13:30–18:00 (GMT+8) Tel: +86 755 26865970/8037 Fax: +86 755 26860497 E-mail: service1@zondan.com Service and support are available in Chinese and English only. Before calling for service, note the following information: • Model and serial number of the monitor •...
  • Page 7 output port configures a medical system and is therefore responsible to ensure that the system complies with the requirements of standard IEC 60601-1. Never permanently install equipment connected to the signal input or output ports. If in doubt, contact MEDHealth Supplies. To avoid mixture, clear all historical data of the last patient before monitoring a new patient.
  • Page 8 The monitor must conform to the international standard IEC 60601-1-2 and other applicable EMC standards. Interference takes place when electromagnetic energy is extremely high. Ensure that any nearby instruments are also in compliance with EMC standards. Never turn on or use portable communication devices like mobile phones or portable dual-channel radios near a monitor.

  • Page 9: Table Of Contents

    Contents Contents ............................9 Chapter 1 Overview ......................... 15 1.1 Indications for Use .......................... 15 1.2 Intended Use ............................ 15 1.3 Configurations ..........................15 Chapter 2 Basic Operation ....................... 16 2.1 Before You Begin ..........................16 9.4.1 Unpacking the Equipment ..................... 16 9.4.2 Setting up the Monitor ....................
  • Page 10 3.3.2 Flashing Numeric Values ....................35 3.3.3 Alarm Messages ....................... 35 3.4 Audible Alarms ..........................35 3.4.1 Turning On/Off Audible Alarms ..................36 3.4.2 Silencing Alarms ......................37 3.4.3 Adjusting the Alarm Volume .................... 37 3.5 Setting Alarm Limits ........................37 3.5.1 Setting Individual Alarm Limits ..................
  • Page 11 6.7.2 Changing the Color of the SpO Waveform ..............54 6.8 Configuring the SpO Pulse Rate Display ..................54 6.9 Changing the SpO Alarm Settings ....................54 6.10 Changing the PR Alarm Settings ....................54 6.11 Masimo SpO Setup ........................55 6.11.1 Change Average Time .....................
  • Page 12 9.5 Exhaust gas from emission system ....................70 9.6 Setting CO2 alarm ......................... 70 9.7 Carbon dioxide safety information ....................70 Chapter 10 Monitoring Invasive Blood Pressure ..............71 10.1 Using the IBP ..........................71 10.2 Selecting a Pressure Transducer ....................71 10.3 Before Measuring Invasive Blood Pressure ..................
  • Page 13 12.2.4 TB Measurement ......................87 12.3 Changing the C.O. Alarm Settings ....................87 12.4 Safety Information ........................87 Chapter 13 Monitoring CSI (Optional) ..................88 13.1 Measurement Principle ........................88 13.2 Parameters ............................. 88 13.2.1 CSI% ........................... 88 13.2.2 CSI Scale ........................88 13.2.3 EMG ..........................
  • Page 14 17.2.4 Cleaning the Temperature Probe ................101 17.3 Disinfecting the Monitor ......................102 17.4 Sterilizing the Monitor ......................102 Chapter 18 Maintaining the Battery ..................103 18.1 Charging LED ........................... 103 18.2 Battery Indicators ........................103 18.3 Installing and Changing the Battery ..................103 18.4 Recharging the Battery ......................

  • Page 15: Chapter 1 Overview

    What you see on the screen, how the menus appear and so forth, depends on the way it has been configured for your hospital. 1.1 Indications for Use The iMD 12 Patient Monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. 1.2 Intended Use...

  • Page 16: Chapter 2 Basic Operation

    Chapter 2 Basic Operation This chapter describes how to set up and begin using the iMD 12 Patient Monitor. 2.1 Before You Begin Before patient monitoring, ensure that the monitor is in good condition and used in the proper environment.

  • Page 17: Monitor Power Supply

    Network setup of the iMD 12 Patient Monitor is not user configurable. Please contact your service personnel. 9.4.4 Monitor Power Supply You can power the monitor with either an AC power source or its internal battery. You can switch back and forth between supplies without powering off the monitor.
  • Page 18 Figure 2-1 Front Panel Figure 2-1 Front Panel The following table describes the controls on the monitor. Table 2-1 Monitor Controls Item Icon Meaning Description Number Alarm Led See chapter 3, Alarms for more information. Press and hold for two seconds to turn the monitor on or off.

  • Page 19: The Rear Panel

    Table 2-1 Monitor Controls (continue) Item Icon Meaning Description Number Waveform Press to freeze the waveforms when monitoring. Press again to unfreeze the waveforms. Freeze key When a menu is displayed, rotate and press the Navigation wheel navigation wheel to select and change the settings. Alarm pauses Start or stop the alarm Silence...

  • Page 20: The Side Panels

    Used for power supply and Module box contract date transfer 2.2.3 The Side Panels The following figure shows the left and right-side panels of the iMD 12 Patient Monitor. The following table describes the side panels iMD8/iMD12 Instructions Manual First Edition: May 2018...

  • Page 21: The Bottom Panel

    SpO2 connector Battery door Recorder door 2.2.4 The Bottom Panel The following figure shows the bottom panel of the iMD 12 Patient Monitor. iMD 8/iMD 12 Figure 2-4 The Bottom Panel 2.3 Screen Display The monitor displays parameters, waveforms, and relevant information of patient measurements.

  • Page 22: Icons On Menu Area

    The following figure shows a typical screen display. Figure 2-5 Example of Screen Display The following table describes the screen display. Table 2-4 Screen Display Description Item Item Description Description Number Number Monitor status Date and time Waveforms Patient information Menu area Technical alarm messages Numeric panes...
  • Page 23 Meaning Icon Description Interface Change screen Page Up Instructions Manual First Edition: May 2018...
  • Page 24 Table 2-5 Icons Description(continue) Meaning Icon Description Silence Press to pause or restore alarms. Record Press to start or stop recordings. All waveforms, alarm, NIBP, graphic and tabular trends Information review review Freeze Press to freeze or unfreeze waveforms. Main Pressing it will enter the main menu for monitor set up.

  • Page 25: Using The Monitor Menus

    Table 2-5 Icons Description(continue) Meaning Icon Description Record Start or stop the recorder record Lock Lock the monitor screen Alarm pauses Start or stop the alarm 2.4 Using the Monitor Menus You can configure the monitor system and measurement settings with the monitor menus. The functions can be accessed by rotate the navigation wheel or touch screen and function key.

  • Page 26: Using The Dynamic Trend Screen

    Figure 2-6a Example of Big Number Display To display Big Number screen: Enter Main menu. Enter Setup Choose to display optional at Select Interface. A List box appears. Choose and press to confirm. Big Numeric 2.5.2 Using the Dynamic Trend Screen In the dynamic trend view, the monitor displays the most recent trends.

  • Page 27: Using Standard Mode

    Figure 2-7a Example of Dynamic Trend Screen To display dynamic trend screen: Enter Main menu. Enter Setup Choose to display optional at Select Interface. A List box appears. Choose and press to confirm. Dynamic Trend 2.5.3 Using Standard Mode Figure 2-8a Example of Standard interface Screen To display Standard interface screen: Enter Main menu.

  • Page 28: Displaying The Other Bed Screen

    Figure 2-9a Example of OxyCRG Screen To display the OxyCGR screen: Enter Main menu. Enter Setup Choose to display optional at Select Interface. A List box appears. Choose and press to confirm. OxyCRG An OxyCRG screen displays a compressed RESP waveform and beat-to-beat trends for HR and SpO To configure the time span of the OxyCRG: Enter OxyCRG area, OxyCRG Setup window appears.
  • Page 29 Figure 2-10 Example of Other Bed Screen To display the Other Bed View Screen: Enter Main Menu. Enter Setup. Choose the display optional at Select Interface. A List box appears. Choose Other Bed Screen and press to confirm. You can view monitoring data from another bed monitored on the same local area network.

  • Page 30: Using Standby Mode

    Message Area: shows physiological and technical messages from the currently viewed bed. All the changes can be operated at setup menu of Other Bed Screen. Such as choose Monitor name, Bed number, patient name, and IP. Also, you can setup alarm for High, Medium, or Low. Note —...

  • Page 31: Changing The Waveform Color

    6.25mm/s,12.5mm/s,25.0mm/s RESP 6.25mm/s,12.5mm/s,25.0mm/s 6.25mm/s,12.5mm/s Multi-Gas 6.25mm/s,12.5mm/s, 6.25mm/s,12.5mm/s,25.0mm/s Note —When you change the speed of an ECG, IBP, or SpO2waveform, you also change the speed for the other waveforms. This is the same for RESP and CO waveforms. 2.5.3 Changing the Waveform Color You can configure the color of each waveform.

  • Page 32: System Maintenance Menu

    CHINESE ENGLISH 2.6.2 System Maintenance Menu Only service personnel are authorized to configure the monitor for troubleshooting, service or restoring factory settings. The System Maintenance menu for factory password is protected and not available to the user. 2.6.3 Changing the Date and Time Warning Changing the Date and Time deletes all data at the bedside (including stored trends and events).
  • Page 33 – : selects Male Female – : select edi. or Type Adult Neo. – Pace: Pacemaker Detect, select ON or OFF. – : selecting clears patient data. Ensure that all necessary reports New Patient are printed before selecting . Selecting keeps the current measurement data.

  • Page 34: Chapter 3 Alarms

    Chapter 3 Alarms This chapter describes how to configure alarms, including alarm levels and alarm limits. The alarm information in this chapter applies to all measurements. Alarms for specific measurements are described in their respective chapters. Alarms sound when the monitor senses an irregular condition either in monitor operation or alarm limits.

  • Page 35: Flashing Numeric Values

    Table 3-1 Alarm LEDs Light Color High priority alarm Red, fast flicker Table 3-1 Alarm LEDs (continue) Light Color Medium priority alarm Yellow, slow flicker Yellow, keep lighting without Low priority alarm flicker Reminder light Blue, flicker Note — If more than one alarm condition is active, the monitor signals the most severe. 3.3.2 Flashing Numeric Values When a parameter value exceeds the preset alarm limits, the corresponding numeric flashes.

  • Page 36: Turning On/Off Audible Alarms

    Medium Three short beeps repeat every 25 seconds, DU-DU-DU Two short beeps repeat every 25 seconds. Warning Do not rely exclusively on the audible alarm system for patient monitoring. Changing the alarm volume to a low level or turning it off during patient monitoring could result in patient danger.

  • Page 37: Silencing Alarms

    3.4.2 Silencing Alarms To silence all audible alarms, press the Alarm Silence menu. Audible alarms silence for two minutes and resume when the timeout counter reaches 00:00. When all audible alarms are silenced, the monitor displays the Alarm Silence icon Alarm Silence remind area.

  • Page 38: Restoring Default Alarm Limits

    Choose Alarm Level, High and Medium are options. Set up alarm limit at Alarm High Limit and Alarm Low Limit. Exit the menu. Method 2: Enter Alarm Setup at menu area ECG, SpO , TEMP, NIBP, RESP Alarm Setup are options. Choose one parameter and press to confirm.

  • Page 39: Chapter 4 Monitoring Ecg

    Chapter 4 Monitoring ECG This chapter describes ECG monitoring on the iMD 12 Patient Monitor. An electrocardiogram (ECG) monitors the electrical activity of the heart. The Monitor processes these electrical signals and displays an ECG waveform on the screen with its numeric on the numeric pane.
  • Page 40 Table 4-1 Lead Description (continue) AAMI Lead Color Lead Color Black Yellow Green Green Black Brown White Brown/Red White/Red Brown/Yellow White/Yellow Brown/Green White/Green Brown/Blue White/Brown Brown/Orange White/Black Brown/Violet White/Violet When placing electrodes, choose a flat, non-muscular site where the signal will not be affected by movement or bones.

  • Page 41: Changing A Lead Set

    Figure 4-1 Three-Lead Locations The following figure shows the 5-lead ECG electrode locations: Figure 4-2 Five-Lead Locations The following figure shows the modified 12-lead ECG electrode placement: Figure 4-3 12-Lead Locations 4.1.1 Changing a Lead Set A pair of electrodes forms a lead. Each lead provides a different view of the same cardiac activity.

  • Page 42: Lead Recommendations For Surgical Patients

    Note — When Three Lead is selected, only one ECG waveform channel displays on the screen. To select an ECG lead: Enter ECG Setup menu at numeric panes. Choose ECG 1 or ECG 2. A lead set option (see Table 4-2) appears. Choose one lead and confirm.

  • Page 43: Ecg Waveform And Numeric Pane

    numeric values. The monitor can display up to 7 ECG waveforms at the same time on the screen. 4.2.1 ECG Waveform and Numeric Pane The following figure shows a typical ECG waveform (ECG1, for example) and numeric pane: Figure 4-3 Typical ECG Waveform and numeric pane 1 = 1 mV calibration bar 2 = ECG lead 3 = ECG gain...

  • Page 44: Displaying Twelve Ecg Waveforms

    Enter ECG numeric pane ECG Setup window appears. Enter Other Setup, ECG Other Setup windows appears. Press ECG Display, a List box appear. Choose Multi-Lead Display. Exit the menu. 4.2.3 Displaying twelve ECG Waveforms Depending on options, the monitor can display twelve ECG waveforms at the same time and the heart rate value in ECG numeric pane.

  • Page 45: Changing The Ecg Waveform Speed

    addition, a 1 mV calibration bar displays on the left of the ECG1 channel. The following table describes the ECG scale: Table 4-3 ECG Scale When the ECG Gain is The scale height X0.25 is 2.5 mm. X0.5 is 5 mm. is 10 mm.

  • Page 46: Changing The Ecg Mode

    4.5 Changing the ECG Mode The monitor has three ECG modes for different monitoring environments: Monitor . The current ECG mode displays on top of the ECG1 channel. Operation Diagnostic To change the ECG mode: Enter ECG Setup menu at numeric panes. Press filter, a List box appears.

  • Page 47: The Arrhythmia Display

    4.7.3 The Arrhythmia Display The following figure shows an example of the ARR waveform and the numeric pane: Figure 4-6 ARR Waveform and Numeric Pane 1 = 1 mV calibration bar 2 = ECG lead of ARR occurrence 3 = ECG gain of ARR occurrence 4 = ECG mode of ARR occurrence 5 = ARR waveform 6 = ECG numeric pane label...
  • Page 48 Ensure that the ECG connectors or electrodes never meet other conductive parts, or with ground. Ensure that all of the ECG electrodes are attached to the patient. For pacemaker patients, the monitor can continue to count pacemaker rate during cardiac arrest or some arrhythmias. Do not rely entirely upon the monitor’s alarm. Keep pacemaker patients under close surveillance.

  • Page 49: Chapter 5 Monitoring Respiration

    Chapter 5 Monitoring Respiration Respiration can be measured using one of the following methods: • ECG. The monitor measures the thoracic impedance between two ECG electrodes on the patient’s chest. Changes in the impedance due to thoracic movement produce the Resp waveform on the monitor screen. The monitor counts the waveform cycles to calculate the respiration rate (RR).

  • Page 50: Changing The Respiration Display

    1 = Resp waveform label 2 = Resp lead 3 = Resp waveform 4 = Resp numeric pane label (respiration rate unit) 5 = Resp rate Note — If the detected respiration rate is close to the heart rate, the alarm message Beat displays.

  • Page 51: Changing The Respiration Alarm Settings

    required for use if electro-surgery is being performed. Implanted pacemakers which can adapt to the Minute Volume may occasionally react on the Impedance measurement used by patient monitors for the determination of the Resp value and execute pacing with the maximum programmed rate.

  • Page 52: Chapter 6 Monitoring Spo2

    Chapter 6 Monitoring SpO2 Pulse oximetry uses a motion-tolerant signal processing algorithm. It provides these measurements: • Oxygen saturation of arterial blood (SpO ) percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin. • Pleth waveform – A visual indication of a patient’s pulse. •...

  • Page 53: Measuring Spo

    6.4 Measuring SpO Note — Clean the sensor surface with 70% ethanol before and after use. Never immerse the sensor in liquid. To start monitoring SpO Select a sensor of the correct type and size and attach it to the patient site. Connect the SpO cables and ensure a good connection.

  • Page 54: Changing The Spo

    Figure 6-1 Pleth Wave and SpO Numeric Pane 1 = SpO waveform label 2 = Pleth wave 3 = SpO numeric label 4 = SpO unit 5 = PR numeric label 6 = PR value 7 = Perfusion numeric label 8 = SIQ label 9 = SpO Alarm high and low limit...

  • Page 55: Masimo Spo Setup

    Method 2: Enter Alarm Setup menu at menu area. Enter SpO Alarm Setup. Set up PR limits at PR High Limit and PR Low Limit. Exit the menu. 6.11 Masimo SpO Setup Press SpO Setup Menu enter into Masimo Setup, you can: ⚫...

  • Page 56: Change Pi Alarm High/Low Limit

    6.11.5 Change PI alarm high/low limit Change PI alarm high/low limit: Enter Masimo Setup menu Select alarm high/low limit, High limit is 3-20; Low limit is 0-18. Exit the menu. Note — Only Masimo SpO has the functions included in 6.11 Masimo Setup menu 6.12 Safety Information Warning Continuous monitoring might make skin red, blistered, or cause compression...

  • Page 57: Chapter 7 Monitoring Nibp

    Chapter 7 Monitoring NIBP The monitor uses the oscillometric method for measuring NIBP. The principle of the Oscillometric method of measuring blood pressure is stopping the arterial blood stream with the pressure of the inflation cuff. As the cuff pressure decreases, the air pressure oscillation wave caused by the blood stream can be measured in the cuff.

  • Page 58: Measurement Limitations

    Do not re-use disposable NIBP cuffs. For more information on NIBP cuffs, see NIBP Accessories on page 96. 7.2 Measurement Limitations NIBP measurements are impossible with heart rate extremes of less than 40 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible: •...

  • Page 59: Selecting The Nibp Interval Time

    The monitor inflates the cuff at the start of each measurement cycle and collects NIBP values. In mode, if the patient blood pressure is high, the monitor adjusts the Auto maximum inflation pressure by re-inflating the cuff. The NIBP measurement automatically stops if NIBP values cannot be correctly collected in the mode.

  • Page 60: Viewing Nibp Measurement Data

    parameters are displayed on the monitor. 7.7 Viewing NIBP Measurement Data After a complete NIBP measurement, the NIBP measurement value displays in the NIBP numeric pane. When no menu is on the monitoring screen, choose NIBP Review menu or Review menu to view the data in the NIBP list.
  • Page 61 Never apply the blood pressure cuff to the same extremity as the one to which an sensor is attached because the cuff inflation disrupts SpO monitoring and leads to nuisance alarms. Select an appropriate cuff and ensure that the correct patient type is selected before monitoring.

  • Page 62: Chapter 8 Monitoring Temperature

    Chapter 8 Monitoring Temperature This chapter describes how to monitor body temperature. The monitor measures temperature through the sensor temperature and electrical impedance. The monitor can measure two temperatures simultaneously, TEMP1 and TEMP2. The monitor displays the temperature values and the difference between these two temperatures in the numeric panes.

  • Page 63: The Temperature Display

    The temperature parameter value stabilizes and displays in the temperature numeric panes. 8.4 The Temperature Display The monitor displays two temperature values in the numeric pane. The following figure shows an example of a temperature numeric pane. Figure 8-1 Temperature Numeric Pane 1 = TEMP Numeric Pane label 2 = TEMP value 3 = T1 label...

  • Page 64: Safety Information

    8.8 Safety Information Warning The disposable probes are sterile and should be handled accordingly. See the probe package for a Use by date. Use only the specified probes for your monitor. When the probe is disconnected or loose, the monitor stops measuring the temperature with no audible alarm.

  • Page 65: Chapter 9 Monitoring Co2

    Chapter 9 Monitoring CO2 9.1 Brief introduction CO2 monitoring is based on the principle that some gases absorb infrared radiation. It can measure the patient's carbon dioxide (ETCO2 and inco2) and respiratory rate. CO2 is measured by infrared absorption of gas Each gas has its own unique absorption characteristics.

  • Page 66: Measurement Of Co2

    Figure 9-1 nasal tube connection diagram For patients who prefer oral breathing, oral nasal tube can be used. Trim the tip of the sampling tube according to the need to meet the needs of patients. It should go down through the teeth and be placed in the mouth. If the tip needs to be corrected, remove the catheter from the patient's face.

  • Page 67: Setting Co2

    ⚫ Fluid pollution ⚫ Reuse disposable catheters ⚫ The position of catheter is not correct To measure CO2, the steps are as follows: 1. Plug the sensor cable into the CO2 interface and allow the sensor to warm up for 2 minutes. 2.

  • Page 68: Change Of Measurement Mode

    2. Select the unit, mmHg, kPa and%. 3. Exit the menu. Note - when the CO2 unit is changed, the pressure units of other monitoring parameters will also change. 9.4.3 Change of measurement mode The measurement mode of CO2 is divided into measurement and standby. In standby mode, the module is in a low power consumption state.

  • Page 69: Change O2 Compensation

    The calculation cycle of CO2 is selected as follows: 1. Enter another CO2 settings menu. 2. Select the calculation cycle, you can select a breath, 10 seconds, and 20 seconds. 3. Exit the menu. 9.4.7 Change O2 compensation To change O2 compensation, the steps are as follows: 1.

  • Page 70: Select The Default Configuration

    1. Enter another CO2 settings menu. 9.4.11 Select the default configuration. select Yes to save all configurations of the current patient type as the factory default configuration. if no is selected, the current operation will be abandoned, and the original configuration content will remain unchanged.

  • Page 71: Chapter 10 Monitoring Invasive Blood Pressure

    Chapter 10 Monitoring Invasive Blood Pressure Invasive blood pressure (IBP), or direct blood pressure measurement, provides accurate blood pressure values of the cardio-artery area. IBP monitoring can track transient variations of arterial blood pressure; however, a catheter must be inserted through the skin into the blood vessel where skin damage can occur.

  • Page 72: Zeroing The Pressure Transducer

    To select a pressure: Enter IBP Setup at numeric pane. Choose Channel 1 or Channel 2 at IBP Setup Menu. Choose the needful pressure label; refer to table 10-1. Exit the menu. Table 10-1 IBP Pressure Labels Label Description Label Description Arterial blood pressure Pulmonary artery pressure...

  • Page 73: Changing The Invasive Blood Pressure Waveform Display

    Figure 10-1 IBP Waveform and Numeric Pane 1 = calibration bar 2 = CH1 pressure type 3 = IBP1 waveform 4 = IBP Numeric Pane label 5 = IBP unit 6 = Systolic pressure (CH1 in this example) 7 = Mean arterial pressure (CH1 in this example) 8 = Diastolic pressure (CH1 in this example) 10.7 Changing the Invasive Blood Pressure Waveform Display You can configure the monitor IBP display by changing the IBP settings.

  • Page 74: Changing The Ibp Alarm Settings

    Choose Unit. IBP unit have mmHg and kPa. Exit the menu. Note — When you change the IBP unit, the change displays wherever pressure parameters are. 10.9 Changing the IBP Alarm Settings IBP alarms include alarms for SYS, DIA, and MAP. IBP default alarm limits are different according to the IBP pressure type.

  • Page 75: Chapter 11 Monitoring Gases (Optional)

    Chapter 11 Monitoring Gases (Optional) 11.1 Anesthesia gas overview 11.1.1 Principle of measurement of anesthesia gas module Anesthesia module is used to measure the patient's anesthesia and respiratory gases and could integrated oxygen module. Anesthesia modules use the characteristics that gases could absorb the infrared light to measure the concentration of the gases.

  • Page 76: Connect The Accessory

    Blinking red light Check sampling line 11.2 Connect the accessory Figure 11-1（Gas sampling line) Connect the end of other sampling line to the patient through the gas adapter Use an emission tube to connect with the vent of the module, transport the sample gas to the exhaust gas treatment system Figure11-2.

  • Page 77: Multi-Gas Setup

    to prevent condensation water blocking the sampling line. Cistern is used to collect condensing water drop inside the sampling line, prevent water droplets into modules. When sinks the collected water reached a certain amount, the water must be poured out again after continuing to use, avoid causing gas road congestion.

  • Page 78: Changing Fin2O Alarm On/Off

    Exit the menu. 11.3.4 Changing FiN2O Alarm On/Off: To change FiN2O High Alarm On/Off: Enter Multi-Gas Setup menu at numeric panes. Choose FiN2O High Alarm On/Off, On or Off are options. Exit the menu. 11.3.5 Other Setup of Multi-Gas • Changing Waveform Gain •...

  • Page 79: Changing The Oxygen Compensation

    if the monitor cannot detect any respiration activity within a certain period, the monitor sounds an apnea alarm. The apnea alarm settings for multi-Gas are configured in the same manner. To turn on or off the audible apnea alarm for multi-Gas measurements: Enter Multi-Gas Setup menu at numeric panes.

  • Page 80: Changing Multi-Gas Alarm Setting

    Figure11-3 The Multi-Gas Display ble 11-2Waveform and label description Name Name N2O unit end tidal CO2 label tidal AA label waveform N2O label AA Value N2O waveform AA unit AA label AA2 label AA waveform AA2 Value AA2 label AA2 unit AA2 waveform O2 label O2 label...

  • Page 81: Safety Information

    11.4 Safety Information Warning Disinfect reusable accessories before reusing them. The water trap collects water droplets from the gas sampling line to prevent liquid from entering the multi-Gas module. Empty the water trap when the liquid inside reaches a certain volume to prevent airway blockage. Position the airway adapter with the spirometry tubing pointing upwards to avoid water droplets entering and blocking the gas sampling line.

  • Page 82: Chapter 12 Co Monitoring (Optional)

    Chapter 12 CO Monitoring (Optional) 12.1 General Information C.O. is short for Cardiac output measurement. It uses regular thermodilution method to measure “Blood Temperature (TB)”, “C.O. calculation” and “hemodynamics calculation”. 12.1.1 Measurement Theory Cardiac output measurement is to place a special floating vessel into pulmonary artery through the peripheral vein.

  • Page 83: Measurement

    Figure 11-1 C.O. accessories connection 12.2 C.O. Measurement Influencing Factors: • Injection Temperature • Injection Volume • Patient Blood Temperature Baseline • Patient Inspiration/Expiration Circle. • Contact Area between Floating Vessel Terminal and Pulmonary • Catheter • Patient HR and Hemodynamics Status •...

  • Page 84: Setup

    Figure 11-2 C.O. Interface Table 11-1 Screen Display Description Item Item Description Description Number Number Current Measurement Previous Measurement Value and Curve Window Injection Temperature Information Remind Parameter Display Function Key Current Measurement Value and Curve Current display area shows current monitoring value and curve which include C.O., C.I., TB, and TI.
  • Page 85 Warning Inject vol and Calculation constant must match the requirement of catheter used. When catheter changed, please renew calculation constant according to the vessel manual 12.2.2.2 Auto TI To setup the mode of TI: 1. Enter C.O. Setup menu. 2. Select Auto TI, Manual and Auto are options. Under Auto mode, injection temperature will be measured automatically.

  • Page 86: Hemodynamics Calculation

    – Yes, save current patient information as factory default configuration. – No, give up current operation and default configuration will be the same. 3. Exit the menu. 12.2.3 Hemodynamics Calculation Through Hemodynamic and input parameters to calculate output parameters. At C.O. Interface, press “Calculation” enters “Hemodynamics Calculation” menu, In Hemodynamics Calculation menu, input parameters and press “calculation”...

  • Page 87: Tb Measurement

    Note —In hemodynamics calculation, parameters are necessary. There will not be calculation results if relevant parameters are not input. 12.2.4 TB Measurement When C.O. is not measured, TB can be monitored. The thermistor at the end of the vessel in the pulmonary artery is used to monitor the blood temperature. During C.O. monitoring, TB alarm will be shield in case of mis-alarm, after monitoring the TB alarm will auto recovery.

  • Page 88: Chapter 13 Monitoring Csi (Optional)

    Chapter 13 Monitoring CSI (Optional) 13.1 Measurement Principle The monitor is intended to monitor the hypnotic state of brains by EEG signals data acquisition from anaesthetized or sedated patients in all areas of the hospital. The monitor is a non-invasive measurement tool operated by a trained professional to measure consciousness level during general anesthesia and sedation using frequency content variations of the spontaneous EEG.

  • Page 89: Emg

    13.2.3 High levels of facial muscular or electromyographic (EMG) activity can interfere with the CSI under certain circumstances. The monitor incorporates an EMG filter that removes most of the potential interfering EMG activity. The EMG bar shows the energy of the EMG level in the 75–85 Hz frequency band (0–100 logarithmic). The bar is located on the right side of the display.

  • Page 90: Before Monitoring

    (high sensor impedance or disconnection of sensor leads). Should any of these situations occur, the Red Error light (2) will turn on. The CSI is not calculated during these periods, and the main unit have middle alarm also. 13.3 Before Monitoring 13.3.1 Skin Preparation Dry-abrade the skin gently using the skin prep product or with a dry washcloth or gauze,...

  • Page 91: Changing The Waveform Gain

    the screen. For more information on changing the speed of the waveform, see Changing the Waveform Speed on page 22. The options for IOC waveform speeds are: 25.0 mm/s, 12.5 mm/s and 6.25 mm/s. 13.6 Changing the Waveform Gain. If the IOC waveform is too small or too big, use the IOC Gain menu to adjust the size of the waveform.

  • Page 92: Chapter 14 Review

    Chapter 14 Review 14.1 Trend Table display The Trend Table window displays patient data in a list format. To Trend Table: Enter Trend Table Menu at menu area. Or Enter Review Menu at menu area, press Trend Table comes to menu. Choose RES, a List box appears.

  • Page 93: Nibp Review

    14.3 NIBP Review By NIBP Recall, each measured NIBP result and the corresponding time can be displayed. The patient monitor can display the most recent 1500 NIBP measurement data in the NIBP retrospection. The recall screen may display 10 sets of measurement data. To NIBP Review: Enter NIBP Review Menu at menu area.

  • Page 94: Technical Alarm Event Recall

    Note —The system will automatically keep the alarm event records when its power cut off. But if the power cut is caused by the un-normal ways such as lightning stroke or artificially damaged, the system can’t ensure to keep records. 14.6 Technical Alarm Event Recall The steps of checking the technical alarm event recall: Press the area of alarm to enter technical alarm recall menu.

  • Page 95: Chapter 15 Drug Calculation

    Chapter 15 Drug Calculation The monitor provides a Drug Calculation window to let you calculate a drug concentration, infusion rate, titration rate, and dosage calculation. You can also generate a titration chart for infusion speed and time. 15.1 Calculating the Drug Concentration Enter the following information before calculation: –...

  • Page 96: Using The Titration Chart

    To calculate the titration rate: Enter Drug Calculation menu at menu area. Choose Volume per drop from GTT/ml or GTT/ml, then confirm. The monitor generates and displays the titration rate. Note — If the Drug name, Weight, Total Dose, SOL Volume and is changed, Drop Volume the monitor re-calculates the Infusion Rate...

  • Page 97: Chapter 16 Recording

    Chapter 16 Recording 16.1 About the Recorder The recorder can: ⚫ Could choose the type and amount of parameter to print. ⚫ The real-time parameters and waveform record. 16.2 Loading the Recorder Note —Use only manufactured-supplied thermal paper with a width of 50 mm. using the wrong paper can damage the recorder or cause it not to print Open paper warehouse, insert the paper with spindle.

  • Page 98: Recording

    Put the recorder into slot, when you heard "Ka", the recorder set well. Show in figure 16-3. Power Indicator Close the recorder door Figure 15-3 Fix recorder Note — The recorder has 2 indicators. Generally, “Power” indicator is on when monitor has power;...
  • Page 99 • Avoid exposure to: – High temperature, humidity, direct sunshine, and fluorescent lighting and radiation. – Ambient temperatures over 50℃. – Liquids. – Starch, adhesive agent, oily paper, or carbon paper. – Ethane, oxide, plastic rubber, adhesive tape, fluorescent ink, or red inks. •...

  • Page 100: Chapter 17 Cleaning And Care

    Chapter 17 Cleaning and Care This chapter gives general guidelines on the cleaning and care of your monitor and accessories. Use only the approved cleaning methods and agents listed in this chapter. The warranty does not cover damage caused by using unapproved substances. Cleaning methods described in this chapter have been tested by the manufacturer.

  • Page 101: Cleaning The Accessories

    17.2 Cleaning the Accessories When possible, clean the accessories according to the manufacturer’s instructions. Use the general guidelines in this chapter if you do not have specific product cleaning instructions. 17.2.1 Cleaning the Cables Dampen a soft cloth with one of the following cleaning agents: •...

  • Page 102: Disinfecting The Monitor

    for a short time . 17.3 Disinfecting the Monitor To avoid long-term damage to the equipment, do not disinfect unless directed by the hospital. Warning Never mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result . Clean the equipment before disinfecting.

  • Page 103: Chapter 18 Maintaining The Battery

    Chapter 18 Maintaining the Battery You can power the monitor with either an AC power source or its optional Lithium-ion battery. Warning Only use batteries specified by the manufacturer. Other batteries can cause monitor damage or personal injury. 18.1 Charging LED A battery symbol on the front panel indicates the charging LED.

  • Page 104: Recharging The Battery

    To remove the battery: Power off the monitor, unplug the power cable or other wires. Lay the monitor, keep its screen up, and open the battery cover by screwdriver. Push the battery holders to the side and pull the battery strap to release the battery. To install the battery：...

  • Page 105: Chapter19 Maintenance And Troubleshooting

    Chapter19 Maintenance and Troubleshooting Warning Failure to implement a satisfactory maintenance schedule for this equipment may cause undue equipment failure and potential health hazards. If you meet a problem with any of the equipment, pls contact professional service personnel . 19.1 Inspecting the Equipment and Accessories Perform a visual inspection before every use.
  • Page 106 Use the following tables to troubleshoot problems with the monitor and accessories. Table 19-2 ECG Problems Problem Solution • Check the patient’s ECG signal • Check/adjust the lead position • Check/reclean skin HR or ARR measurements inaccurate • Check/replace ECG electrode •...
  • Page 107 • Check the extension tube for breakage and if the tube is damaged, replace it. Table 19-4 NIBP Problems (continue) Problem Solution displays in the A blood pressure reading has exceeded the pressure Pressure Range Exceeded NIBP numeric pane. range. The monitor cannot take any more NIBP readings until the alarm is acknowledged.

  • Page 108: Disposing Of The Monitor

    Problem Solution No C.O. catheter is detected. No C.O catheter displays. No Injection temperature sensor is detected. No Injection temperature sensor The Injection temperature is over 30 C. Change the Injection temperature too high Injection solution and perform the measurement again. The injection began 10 seconds after you pressed Start in the Cardiac Measurement window.

  • Page 109: A Accessories

    A Accessories This appendix describes the accessories that are compatible with the iMD 12 Patient Monitor. Table A-1 Accessories list Accessories Specification ECG cable Integrated 5-leads Cable, clasp type, A5038-EC1 NIBP cuff Adult. M5124 A1802-SA126PV probe Reusable Adult Clip Sensor,...

  • Page 110: B Specifications

    B Specifications This appendix describes the specifications of the iMD 12 Patient Monitor. B.1 ECG/ST/Arrhythmia Specifications The following table describes the ECG/ST/arrhythmia specifications. Table B-1 ECG Specifications Parameter Specifications CMRR (Common mode rejection CMRR≥90 dB ratio) Adult/Pedi: 15bpm - 300bpm...

  • Page 111: Respiration Specifications

    Table B-1 ECG Specifications (continue) Parameter Specifications Ventricular bigeminy: 80 bpm±2bpm Slow alternating ventricular bigeminy: 60 bpm ±2bpm Heart ratemeter accuracy response to irregular rhythm Rapid alternating ventricular bigeminy: 120 bpm ±2bpm Bidirectional systoles: 90 bpm±2bpm ≤ HR change from 80 bpm to 120 bpm: 8 s maximum -Response time of heart rate meter ≤...

  • Page 112: Temperature Specifications

    two-thirds of pulse oximeter equipment measurements can be expected to fall within the Arms value measured by a CO-oximeter. Note — It is not necessary to have a SpO calibration when the monitor is in use. The following table describes the SpO specifications.

  • Page 113: Non-Invasive Blood Pressure Specifications

    B.5 Non-invasive Blood Pressure Specifications The following table describes the NIBP specifications. Table B-5 NIBP Specifications Parameter Specification Measuring method Oscillometric method Measuring parameter SYS, DIA, MAP, Unit mmHg or kPa Work mode Manual, Auto, Stat Cycle time 1-5,10, 15, 30, 60, 90, 120, 180, 240, 480 minutes Adult: 40 mmHg -270mmHg (5.3 kPa - 36.0kPa) SYS range Pediatric: 40 mmHg - 200mmHg (5.3kPa - 26.7kPa)

  • Page 114: Invasive Blood Pressure Specifications

    Specifications (continue) Table B-6 CO Parameter Specification Waveform speed 6.25 mm/s, 12.5 mm/s Alarm delay <10s B.7 Invasive Blood Pressure Specifications The following table describes the IBP specifications. Table B-7 IBP Specifications Parameter Specification ART 0 - 300 mmHg PA -6 - 120 mmHg CVP -10 - 40 mmHg IBP range RAP -10 - 40 mmHg...
  • Page 115 CO2：250ms（Decrease Time 200ms） N2O：250ms Increase Time O2 ： Refer to Specification of Oxygen Sensor HAL, ISO,SEV,DES：300ms ENF：350ms Alarm delay < 4s 5Vol% ～ 100 Vol% O2 Measure range O2 Accuracy ±3vol% 0 Vol% ～ 5 Vol% Enflurane Measure range Enflurane Accuracy ±（0.15 vol%+15% rel）...

  • Page 116: Csi Specification

    CSI Specification Table B-9 CSI Specifications Parameter Specification CSI and upgrade 0-100, Filter 6-42Hz，1 sec. upgrade EMG and upgrade 0-100 logarithmic. Filter 75-85Hz，1 sec. upgrade 0-100%，Filter 2-42Hz，1 sec. upgrade Accuracy ±2 or ±10%, which is greater Waveform Speed 6.25mm/s、12.5 mm/s、25mm/s Waveform Gain 10、20、40、80、100、150、200 EEG Sensitivity...

  • Page 117: Display Specifications

    the monitor powers off if the battery power is almost depleted. B.11 Display Specifications The following table describes the display specifications. Table B-11 Display Specifications Parameter Description Type Color TFT LCD iMD 8 display Size 8.4” iMD12 display Size 12.1” B.12 Recorder Specifications The following table describes the recorder specifications.

  • Page 118: Interface Specifications

    B.14 Interface Specifications The following table describes the interface specifications. Table B-14 Interface Specification Parameter Specification Isolation 1.5 kV Delay time <0.5 s Data output Via Ethernet port Defib sync 0 to 5V pulse Software upgrade USB port Instructions Manual First Edition: May 2018...

  • Page 119: C Alarm

    C Alarm C.1 The physiological alarm information Table C-1 Physiological alarm information Alarm Source Level Reason and Solution information XX value has exceeded the high alarm XX Too High HIGH or MED limit or below the low alarm limit. Check the patient physiological status, XX Too Low HIGH or MED patient type and alarm limit setup.

  • Page 120: The Technical Alarm Information

    system cannot analyze the data. Check the patient, electrodes, cables and leads. Table C-1 Physiological alarm information (continue) Alarm Source Level Reason and Solution information The patient RR cannot measure since Resp Cardiac RESP HIGH heartbeat interrupts RESP. Check the (continue) Overlay patient, electrodes, cables and leads.
  • Page 121 ST1 Exceed ST2 Exceed...
  • Page 122 Table C-2 Technical alarms information (continue) Source Alarm information Level Reason and Solution ST3 Exceed ST4 Exceed ST5 Exceed ECG parameter value is over range; please (continue) contact your service representative. ST6 Exceed ST7 Exceed ST8 Exceed Probe Off The SpO sensor disconnected from the patient No Sensor or monitor or module.
  • Page 123 monitor specification, if any special cause impact Table C-2 Technical alarm information (continue) Source Alarm information Level Reason and Solution The patient PR is too weak or cuff loose, Low Signal check the patient and replace the cuff site. If it fails replace the cuff.
  • Page 124 IBP parameter alarm limit is accidental IBP1 Alarm Limit Error modified; please contact your service IBP2 Alarm Limit Error representative. Table C-2 Technical alarm information (continue) Source Alarm information Level Reason and Solution IBP1 SYS Exceed IBP1 DIA Exceed IBP1 MEAN Exceed IBP parameter value is over range;...
  • Page 125 Check sensor connection. Table C-2 Technical alarms information (continue) Source Alarm information Level Reason and Solution Module Initialization Error1 Module Initialization Error2 There is a module error, or communication Module Initialization between the module and main board has Error3 failed, restart. Module Initialization Error4...

  • Page 126: D Glossary

    D Glossary This appendix defines some terminology and abbreviations. D.1 Terminology Definitions Table D Terminologie Définitions Term Definition a/AO2 Alveolar-arterial oxygen AaDO2 Alveolar-arterial oxygen difference Anesthetic gas Aortic pressure Arrhythmia Arterial pressure Left arm augmented lead Right arm augmented lead Body surface area Blood temperature C.O.
  • Page 127 End-tidal oxygen Table D Terminologie Definitions (continue) Term Definition Femoral artery pressure Gas parameter Halothane Heart rate Invasive blood pressure Intracranial pressure InCO Inspired carbon dioxide In N2O Inspired nitrous oxide Inspired oxygen Invasive blood pressure Isoflurane Left arm Left cardiac work LCWI Left cardiac work index Left leg...
  • Page 128 Right cardiac work Table D Terminology Definitions (continue) Term Definition RCWI Right cardiac work index RESP Respiration Right leg Respiration rate RVSW Right ventricular stroke work RVSWI Right ventricular stroke work index Sevoflurane Stroke index Arterial oxygen saturation from pulse oximetry Stroke volume Stroke volume index Systemic vascular resistance...

  • Page 129: E Electromagnetic Compatibility

    E Electromagnetic Compatibility This appendix lists the tests and compliance levels that make the iMD 12 Patient Monitor suitable for use in the specified electromagnetic environment according to IEC 60601-1- 2: 2014 E.1 Instructions for Use Medical electrical equipment can either generate or receive electromagnetic interference.

  • Page 130: Guidance And Manufacturer's Emc Declaration

    E.2 Guidance and Manufacturer's EMC Declaration The iMD 12 Patient Monitor is intended for use in the electromagnetic environment specified in the following tables. The customer or the user of the iMD 12 Patient Monitor should assure that it is used in such an environment.

  • Page 131: Electromagnetic Immunity For Equipment And Systems Not Life-Supporting

    IEC60601 Test Compliance Test Level Level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the iMD 12 Patient Monitor, including cables, than recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 132: Recommended Separation Distances For Equipment And Systems Not Life-Supporting

    Life-Supporting The iMD 12 Patient Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the iMD 12 Patient Monitor can help prevent electromagnetic interference by maintaining a...

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