EDAN iM3 User Manual
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EDAN iM3 User Manual

Vital signs monitor
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  • Page 2 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.
  • Page 3 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.

  • Page 4: Table Of Contents

    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 ................6 Chapter 2 Installation ........................9 2.1 Initial Inspection ........................9 2.2 Mounting the Monitor ......................
  • Page 5 Chapter 5 Ward Round Mode ......................31 5.1 Patient Information Item Management ................31 5.2 Patient Management ......................31 5.2.1 Create New Patient ....................31 5.2.2 Import Patient ......................32 5.2.3 Delete Patient ......................33 5.3 Choose Patient for Measurement ..................34 5.4 Ward Round Record ......................
  • Page 6 9.2 Technical Alarm Information ....................56 9.3 Prompts ..........................64 9.4 Adjustable Range of Alarm Limits ..................65 9.5 Known Issues and Directions ....................67 Chapter 10 User Interface ....................... 68 10.1 Setting Interface Style ......................68 10.2 Selecting Display Parameters ..................... 68 10.3 Changing Parameter and Waveform Colors ...............
  • Page 7 14.2.1 Introduction ......................90 14.2.2 Probe Covers —Applying & Removing ..............92 14.2.3 Changing Isolation Chambers and Probes .............. 92 14.2.4 Measuring Mode ..................... 93 14.2.5 Measuring Procedure ....................94 14.2.6 TEMP Setup for F3000 Module ................95 14.3 Infrared TEMP with TH Module ..................96 14.3.1 Introduction ......................
  • Page 8 19.4.2 Disinfecting the Reusable Accessories ..............122 19.5 Cleaning and Disinfecting Other Accessories ..............123 19.6 After Reprocessing ......................123 19.7 Storage and Transport ...................... 123 Chapter 20 Maintenance ....................... 124 20.1 Inspecting ......................... 124 20.2 Maintenance Task and Test Schedule ................125 Chapter 21 Warranty and Service ....................

  • Page 9: Chapter 1 Intended Use And Safety Guidance

    Vital Signs Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use/Indications for Use The monitor is 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 monitor is intended for use by trained healthcare professionals in hospital environments.
  • Page 10 IEC/EN 60601-1. If in doubt, consult our technical service department or your local distributor. Only patient cable and other accessories supplied by EDAN can be used. The performance and electric shock protection cannot be guaranteed, and the patient may be injured otherwise.
  • Page 11 Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage.
  • Page 12 The equipment can provide protective means to prevent the patient from being burned when used with HF SURGICAL EQUIPMENT. The equipment can protect against the effects of the discharge of a defibrillator. Use only EDAN-approved accessories. When the monitor is used with HF surgical equipment, the transducer and the cables must be avoided from conductive connection to the HF equipment.
  • Page 13 Remove a battery whose life cycle has expired from the monitor immediately. To ensure patient safety, use only parts and accessories manufactured or recommended by EDAN. Before connecting the monitor to the AC power, make sure the voltage and the power frequency are consistent with the requirements indicated on the device label or in this user manual.

  • Page 14: Explanation Of Symbols On The Monitor

    The monitor can only be used on one patient at a time. If the monitor gets damp or liquid pours on the monitor, please contact the service personnel of EDAN. This monitor is not a device for treatment purposes. The pictures and interfaces in this manual are for reference only.
  • Page 15 Vital Signs Monitor User Manual Intended Use and Safety Guidance Serial number Network port USB (Universal Serial Bus) Connection CE marking AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY Date of manufacture Manufacturer Part Number General symbol for recovery/recyclable Disposal method Operating instructions Refer to instruction manual/booklet (Background: Blue;...
  • Page 16 Vital Signs Monitor User Manual Intended Use and Safety Guidance Output/ Nurse call Chargeable battery Battery check Federal Communications Commission: Contains FCC ID Contains FCC ID: SMQ9113EDAN, or Contains FCC ID: 2AMWOFSC-BT836B Conforms to AAMI Std. ES60601-1,IEC Std. 80601-2-30, IEC Std. 60601-2-49, ISO Std. 80601-2-56, ISO Std. 80601-2-61 Certified to CSA Std.

  • Page 17: Chapter 2 Installation

    NOTE: Connect the power cable to the socket specialized for hospital use. Only use the power cable supplied by EDAN. 2.4 Checking the Monitor Make sure there is no damage on the measurement accessories and cables. Then turn on the monitor, check whether the monitor can start normally.

  • Page 18: Connecting Sensor To Patient

    In this case, readjust the system time after powering on. If the system time cannot be saved and resumes the default value after restart, contact the service department of EDAN to replace the button cell in main board. WARNING Changing date and time will affect the storage of trend data.

  • Page 19: Handing Over The Monitor

    Vital Signs Monitor User Manual Installation 2.8 Handing Over the Monitor If you are handing over the monitor to the end-users directly after configuration, make sure that it is in normal working status and let user know the status. The users must be adequately trained to use the monitor before monitoring a patient. To achieve this, they should have access to, and read, the following documentation delivered with the monitor: User Manual (this book) - for full operating instructions.

  • Page 20: Chapter 3 Basic Operation

    Vital Signs Monitor User Manual Basic Operation Chapter 3 Basic Operation 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. What you see on the screen, how the menus appear and so forth, depend on the way it has been tailored for your hospital and may not be exactly as shown here.
  • Page 21 Vital Signs Monitor User Manual Basic Operation Infrared TEMP Module Alarm When an alarm occurs, the alarm indicator will light or flash. The indicator/Standby color of light represents the alarm level. High level alarm: flashes indicator in red; Medium level alarm: flashes in yellow; Low level alarm: constantly yellow for physiological alarm and constantly blue for technical alarm.

  • Page 22: Rear View

    Vital Signs Monitor User Manual Basic Operation Admit/Create Admitting or creating new patient will clear the data in main interface. new patient • In Monitor mode, press the button to admit a new patient. • In Ward round mode, press the button to create a new patient. •...
  • Page 23 Vital Signs Monitor User Manual Basic Operation Portable handle/Accessory collecting: for lifting or moving the monitor or collecting the accessories Battery compartment latch: for opening or closing battery door. Equipotential grounding terminal. If the monitor is used together with other devices, connect this terminal to eliminate potential ground differences between devices.

  • Page 24: Side View

    Vital Signs Monitor User Manual Basic Operation 3.1.3 Side View Left side Right side Built-in barcode scanner window Heat sink - 16 -...

  • Page 25: Operating And Navigating

    (don’t use wet cotton swab to clean the vent). If NIBP measurement is still affected after cleaning, please contact the service personnel of EDAN. 3.2 Operating and Navigating Everything you need to operate the monitor is contained on its screen. Almost every element on the screen is interactive.
  • Page 26 Vital Signs Monitor User Manual Basic Operation 12 13 14 15 16 18 19 Bed No. Patient name; ID number: in Monitor or Spot-checking mode, it is MRN; in Ward round mode, it is the 1 patient information item (such as MRN, Medical Card, etc.
  • Page 27 Vital Signs Monitor User Manual Basic Operation Scroll left to display more shortcut keys Shortcut key area Storage status indicator of the storage device Removable storage device symbol of USB flash disk e-link connection symbol Wi-Fi network symbol The picture sample above: single battery status symbol : dual batteries status symbol Wired network symbol Scroll right to display more shortcut keys...

  • Page 28: Using Keys

    Vital Signs Monitor User Manual Basic Operation Patient type: ADU Patient type: PED Patient type: NEO Measuring oral TEMP in ADU mode Measuring axillary TEMP in ADU mode For device with Measuring rectal TEMP in ADU mode the T2A or F3000 TEMP module only.
  • Page 29 Vital Signs Monitor User Manual Basic Operation New Patient, to create new patient for spot-checking mode only Select Patient, to select patient for Ward round mode only 3.2.1.2 Shortcut Keys A shortcut key is a configurable graphical key, located at the bottom of the main screen. It gives you fast access to functions.

  • Page 30: Work Modes

    Vital Signs Monitor User Manual Basic Operation 3.2.1.4 Pop-up Keys Pop-up keys are task-related graphical keys that appear automatically on the screen when required. For example, the confirmation pop-up key appears only when you need to confirm a change. 3.3 Work Modes The monitor offers multiple work modes, including Monitor (also called Monitoring), Ward Round, and Spot-checking.

  • Page 31: Night Mode

    Vital Signs Monitor User Manual Basic Operation Function > Standby. 2: Automatic standby: In spot-checking or Ward round mode, if there is no measurement, alarm and operation in process, the monitor can enter standby mode automatically without any operations in specified time. Please enter Menu > System Setup > General > Auto Standby to choose time from 1 min, 2 min, 5 min, 10 min, 30 min, 1 hour or Off.

  • Page 32: Changing Monitor Settings

    Vital Signs Monitor User Manual Basic Operation 3.5 Changing Monitor Settings 3.5.1 Adjusting Screen Brightness To change the screen brightness, select Menu > System Setup > General, and select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright. 3.5.2 Adjusting Volume 3.5.2.1 Adjusting Key Volume The key volume is the volume you hear when you select any field on the monitor screen or when...

  • Page 33: Disabling The Touch Screen

    (in Ward Round mode), last Name, first Name and so on. If internal scanner is configured (please contact EDAN service personnel for activation), user can choose Manual or Auto for Internal Scanner Mode in User Maintain to scan the barcode.

  • Page 34: Chapter 4 Monitor Mode

    Vital Signs Monitor User Manual Monitor Mode Chapter 4 Monitor Mode Monitor mode is used for single patient’s monitoring and management. 4.1 Admitting a Patient The monitor displays physiological data and stores it in the trends as soon as a patient is connected.

  • Page 35: Patient Category

    Vital Signs Monitor User Manual Monitor Mode NOTE: Creating new patient (admission or admission by barcode) and updating patient will clear the history data in the monitor associated with the patient. 4.1.1 Patient Category The patient category setting determines the algorithm which the monitor uses to process and calculate some measurements, the safety limits that are applied for some measurements, and the alarm limit ranges.

  • Page 36: Editing Patient Information

    Vital Signs Monitor User Manual Monitor Mode 4.4 Editing Patient Information To edit the patient information after a patient has been admitted, select Menu > Patient Management > Patient Info., and make the required changes on the popup interface. 4.5 Monitoring Data Review In monitor mode, the monitor provides 120-hour trend data of all parameters, storage of 1200 NIBP measurement results, 200 alarm events and so on.

  • Page 37: Nibp Review

    Vital Signs Monitor User Manual Monitor Mode ■ Select Interval to change the interval of the trend data. 1 s, 5 s, 30 s, 1 min, 3 min, 5 min, 10 min, 15 min, 30 min, 60 min and NIBP are optional. Select NIBP to view the trend data according to the NIBP measurement time.

  • Page 38: Technical Alarm Checking

    Vital Signs Monitor User Manual Monitor Mode 4.5.5 Technical Alarm Checking Click technical alarm area to check the current technical alarms. Technical alarms which have happened earlier and do not presently exist cannot be checked. 4.5.6 Event Marking Event mark is used to note the classified events which are related with patient or may have influence on parameters monitoring, such as take or inject medicine, or kinds of treatments.

  • Page 39: Chapter 5 Ward Round Mode

    Vital Signs Monitor User Manual Ward Round Mode Chapter 5 Ward Round Mode Ward round mode is used for parameter measurement and for multiple patients’ ward round data management (maximum 1000 patients at the same time). 5.1 Patient Information Item Management Before creating new patient, user can set the patient information item as needed.

  • Page 40: Import Patient

    Vital Signs Monitor User Manual Ward Round Mode 2. Press Admit/Create new patient hardkey on the front panel, or 3. Use Select Patient permanent key, and then click icon + in popup window, or 4. Scan patient barcode by using barcode scanning shortcut key. The barcode is based on the 1 patient info.

  • Page 41: Delete Patient

    Vital Signs Monitor User Manual Ward Round Mode bed No. first name last name patient type the 1 patient info. item Xiaoming Wang 12345 … … … … … Step 2: Save the file as CSV with comma delimiter format. The file name should be fixed as ‘ImportPatientList.csv’, and the encoding format of the file should be UTF-8.

  • Page 42: Choose Patient For Measurement

    Vital Signs Monitor User Manual Ward Round Mode This operation can only delete the patient information in Patient Management window but cannot delete patient history data. If the selected patients are in measurement, there will be a confirmation ‘Delete the currently measured patient, confirm?’.

  • Page 43: Ward Round Record Confirmation

    Vital Signs Monitor User Manual Ward Round Mode 5.4.2 Ward Round Record Confirmation In main interface: User clicks Save, and the measurement data in main interface will be stored as a Ward round record in Review menu. User can Save multiple ward round records for a patient. The time of Ward round record is subject to the time of clicking Save.

  • Page 44: Ward Round Record Review

    Vital Signs Monitor User Manual Ward Round Mode sorting, the custom parameter area in the main interface will be displayed accordingly. Set detailed data information for the custom parameters Set and input detailed data information in in the main interface > click Save to store them. The saved custom parameters data details can be viewed in Review menu.

  • Page 45: Chapter 6 Spot-Checking Mode

    Vital Signs Monitor User Manual Spot-checking Mode Chapter 6 Spot-checking Mode Spot-checking mode is used for spot-checking measurement and for management of multiple patients’ spot-checking data. 6.1 Admit Patient There are following ways to admit patient. If monitor is connected to network server, the patient information can be synchronized to the network server after admission.

  • Page 46: Spot-Checking Data Trend Table

    Vital Signs Monitor User Manual Spot-checking Mode for details about uploading and exporting. 6.4 Spot-checking Data Trend Table Spot-checking Data Trend Table locates the bottom of main interface. First line is the latest data. Click triangle at the bottom to show/hide trend table. If monitor is powered off, parameters data and trend data in main interface will be cleared.

  • Page 47: Chapter 7 Networking

    Protecting personal health information is a major component of security strategy. To protect the personal information and ensure the proper device performance, the user should take necessary precautions in accordance with local laws and regulations and institution’s policies. EDAN recommends health care organizations or medical institutions to implement a comprehensive and multifaceted strategy to protect the information and systems from internal and external security threats.

  • Page 48: Network Security

    For safety consideration, please change the password periodically, and a combination of words and numbers is recommended. If Old User Password is forgotten, please contact the service personnel of EDAN. - 40 -...
  • Page 49 Vital Signs Monitor User Manual Networking NOTE: When the monitor is turned on for the first time or after upgrading software, please modify User Maintain password according to the prompts. The default initial User Maintain password is ABC. • Set CMS/Gateway Encryption to Off, AES (default) or TLS when user connects the monitor with network server (MFM-CMS or gateway).

  • Page 50: Wi-Fi

    Vital Signs Monitor User Manual Networking When it is set to On, the user can directly enter the main interface; otherwise, the user needs to enter a password for identity authentication. • Setting User Login Timeout allows the user to lock the screen when the monitor has been idle for a certain amount of time, so that others cannot access the monitor without entering the password.

  • Page 51: Network Disconnected Alarms

    The obstacle may interfere with data transmission and even cause data loss. Use the wireless device recommended by EDAN, otherwise some exceptional situations such as frequent network disconnection may occur on the monitor.

  • Page 52: E-Link Function

    In User Maintain > Network, user can set e-link Name and e-link Key. E-link name setup for monitors of same model has fixed rules. 20 characters are supported at most. For example: iM3 default e-link name “VS_3”. Connection permission (e.g. pairing code) is needed for the first connection. Pairing code supports 6 numbers at most.

  • Page 53: Connecting The Monitor To Mfm-Cms

    Vital Signs Monitor User Manual Networking 7.5 Connecting the Monitor to MFM-CMS The monitor can be connected to the central monitoring system only when it is in monitor mode and also the encryption method is not TLS. Through the network: The monitor sends patient information, real-time monitoring or measurement data to the central monitoring system.

  • Page 54: Gateway Communication

    Vital Signs Monitor User Manual Networking the same to the monitor. For detailed information, please refer to CMS-LITE Data Management Software User Manual. 7.7 Gateway Communication The monitor can be connected to the Gateway (V1.21 or above), which provides clinicians with the capability of viewing and collecting patient data remotely and the data exchange of selected clinical and administrative information between the monitor and the hospital network.

  • Page 55: Uploading Data To Network Server

    Vital Signs Monitor User Manual Networking creation according to the normal operation 7.10 Uploading Data to Network Server Ward round records and spot-checking data can be uploaded to network server. Upload manually: Click Menu > Review > Upload or click review shortcut key directly, user can choose as needed and upload the Ward round records/spot-checking data.

  • Page 56: Chapter 8 Alarms

    Vital Signs Monitor User Manual Alarms Chapter 8 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. 8.1 Alarm Category In monitor mode: the monitor provides two types of alarm, physiological alarms and technical alarms.
  • Page 57 Vital Signs Monitor User Manual Alarms 2. Medium level alarms A medium level alarm warns the operator of a medium priority alarm condition which requires prompt operator response. Failure to respond to the cause of the alarm condition is likely to result in reversible injury of the patient. 3.

  • Page 58: Controlling Alarm

    Vital Signs Monitor User Manual Alarms WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

  • Page 59: Audio Alarm Paused

    Vital Signs Monitor User Manual Alarms WARNING 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. Prior to monitoring, make sure that the alarm limit settings are appropriate for your patient.

  • Page 60: Alarm Reset

    Vital Signs Monitor User Manual Alarms Remind signal: Audio alarm off symbol and Audio Alarm off on a red colored background are displayed with an interval of 2 s during the audio alarm off status. Pressing shortcut key again can resume the audio alarm. NOTE: If a new alarm occurs during the audio alarm off period, the new alarm will not be sounding.

  • Page 61: Delete All Alarm Events

    Vital Signs Monitor User Manual Alarms 8.6 Delete All Alarm Events Select Menu > User Maintain > Alarm > Clear Alarm Log to delete. WARNING The deleted alarm events are beyond retrieve. Please use this function cautiously. 8.7 Testing Alarms When you switch the monitor on, the monitor will prompt two “Di”...

  • Page 62: Nurse Call

    Vital Signs Monitor User Manual Alarms Prior to monitoring, make sure that the limit settings are appropriate for your patient. Setting limits to extreme values may cause the alert system to become ineffective. It is recommended to use the default settings. 8.9 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.

  • Page 63: Chapter 9 Alarm Information

    Vital Signs Monitor User Manual Alarm Information Chapter 9 Alarm Information 9.1 Physiological Alarm Information WARNING During monitoring, the physiological alarms SpO No Pulse and SpO Desat are preset to be on and cannot be turned off. Message Cause Alarm level High User-selectable measuring value is above upper alarm limit.

  • Page 64: Technical Alarm Information

    The pulse signal is too site. problem Low Perfusion weak or the perfusion of exists, please notify the measurement site is (EDAN SpO biomedical engineer too low. manufacturer’s service staff. There is interference with Check the condition measurement of patient and avoid...
  • Page 65 Action Taken Reduce interference of the ambient light Light Ambient light around the and avoid sensor’s Interference sensor is too strong. exposure to strong (EDAN SpO light. NIBP Stop using High (monitor measuring function mode) of NIBP module, NIBP module failure or...
  • Page 66 The cuff type used isn’t Confirm the patient NIBP Cuff Type Error consistent with the patient type and change the (EDAN NIBP) type. cuff. Check whether the Atmospheric pressure or airway is occluded system pressure or pressure sensor NIBP abnormal.
  • Page 67 Vital Signs Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken Maybe the patient blood Use other methods NIBP Range Exceeded pressure value is beyond High to measure blood the measurement range. pressure. Cuff properly Properly wrap the wrapped or no cuff is NIBP Loose Cuff cuff.
  • Page 68 Vital Signs Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken Probe Is Missing probe connected Medium Please change probe cannot be identified. contact Manufacturer’s service staff. Please wait Probe TEMP Too High The original temperature probe temp drop of sensor >+33 °C and and start measuring.
  • Page 69 Vital Signs Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken F3000 TEMP System error during TEMP Error E1 Medium synchronization. System error during Medium patient thermistor TEMP Error E2 calibration. System error during heater Medium TEMP Error E3 thermistor calibration.
  • Page 70 Vital Signs Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken Stop using measuring function of TEMP module; notify biomedical engineer Manufacturer’s service staff. Unable to pre-heat probe TEMP Error P6 NOTE: Measure tip. readings displayed on the screen unreliable when...
  • Page 71 Vital Signs Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken Others High (monitor mode) Please change the Battery Low Battery Low battery or charging. (spot-checking or Ward round mode) Replace the battery restart monitor. Battery Error problem persists, Malfunction in Battery notify...

  • Page 72: Prompts

    Vital Signs Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken 1) Check if the network cable well connected. 2) Check if the MFM-CMS turned on. 3) Check if the IP distributed alarm of bedside monitor Network Disconnect system, monitor’s and MFM-CMS are...

  • Page 73: Adjustable Range Of Alarm Limits

    Vital Signs Monitor User Manual Alarm Information Message Cause Auto Measuring In automatic measuring mode In average measuring mode AVG Measuring Press the “Start/stop NIBP measurement” button to stop Measurem. Canceled the measurement. Calibrating During calibrating Calibrat. Canceled Calibration is over. Leak.
  • Page 74 PR alarm limits are listed as follows: unit (bpm) Adjustable Range PR (SpO EDAN 30~300 Nellcor 30~300 PR (NIBP) EDAN 40~240 SunTech 30~220 NIBP alarm limits are listed as follows: EDAN module: Patient Type Adjustable Range (mmHg) 40~270 10~215 20~235 40~230 10~180 20~195 40~135 10~100 20~110 SunTech module:...

  • Page 75: Known Issues And Directions

    Vital Signs Monitor User Manual Alarm Information TEMP alarm limits are listed as follows: Patient Type Adjustable Range Step ADU/PED +35.5 °C (+95.9 ℉) ~ +42 °C (+107.6 ℉) +0.1 °C (32.2 ℉) 9.5 Known Issues and Directions Known issues Directions When recording the trend graph in Re-print trend graph, and do not...

  • Page 76: Chapter 10 User Interface

    Vital Signs Monitor User Manual User Interface Chapter 10 User Interface Changing some settings may have the risk, so only the authorized person can change them. After changing the settings, please notify the operator. 10.1 Setting Interface Style The user can set the interface based on the requirement, such as: Parameters needing to be monitored.

  • Page 77: Default Configuration

    Vital Signs Monitor User Manual User Interface To rename the user configuration: 1. Select Menu > Default Setup > User Configure. 2. Select a configuration file needed to rename from the list and click on Rename. 3. Enter a name for the configuration file and confirm it. 10.5 Default Configuration To set default configuration, select Menu >...

  • Page 78: Chapter 11 Monitoring Spo

    Use only EDAN permitted sensors and extension cables with the monitor. Other sensors or extension cables may cause improper monitor performance and/or minor personal injury.

  • Page 79: Measuring Spo

    Vital Signs Monitor User Manual Monitoring SpO When a trend toward patient deoxygenation is indicated, analyze the blood samples with a laboratory co-oximeter to completely understand the patient’s condition. waveform is not directly proportional to the pulse volume. The device is calibrated to display functional oxygen saturation. Functional tester or simulator can not be used to assess the SpO accuracy.
  • Page 80 Vital Signs Monitor User Manual Monitoring SpO whose hands are unavailable. Place the finger into the sensor according to the direction of the symbol on the sensor. The fleshiest part of digit should be covering the detector 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).

  • Page 81: Measurement Limitations

    Vital Signs Monitor User Manual Monitoring SpO NOTE: Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. Inspect the sensor to ensure that the light emitter and receiver are aligned with each other and there is no gap between the sensor and the finger.

  • Page 82: Assessing The Validity Of A Spo Reading

    CO-oximeter measurements. The volunteer population in the studies are composed of healthy men and women from age 19 to 37 (for EDAN SpO module), from 18 to 50 (for Nellcor SpO module), with various skin pigmentations.

  • Page 83: Spo Alarm Delay

    This delay is the combination of the configured alarm delay time plus the general system delay time. 11.7 Perfusion Index (PI)* * Only applicable to the EDAN SpO module. PI is a numeric value indicating perfusion level. It reflects the perfusion level at the monitoring site.

  • Page 84: Setting Sensitivity

    Vital Signs Monitor User Manual Monitoring SpO 11.9 Setting Sensitivity The different sensitivity indicates different refresh frequency. High indicates the refresh frequency of SpO value is the most frequent. To change the sensitivity, please follow the steps: Select the SpO Setup menu;...
  • Page 85 Vital Signs Monitor User Manual Monitoring SpO Where: Points = SpO percentage points outside of the limit Seconds = number of seconds that SpO remains at that point outside of the limit The alarm response time, assuming a SatSeconds limit set at 50 and a lower alarm limit set at 90, is described and illustrated below.

  • Page 86: Satseconds "Safety Net

    Vital Signs Monitor User Manual Monitoring SpO 11.11.2 SatSeconds “Safety Net” The SatSeconds “Safety Net” is for patients whose saturation makes frequent excursions below or above the SpO limit but does not remain in violation long enough for the SatSeconds limit to be reached.

  • Page 87: Chapter 12 Monitoring Pr

    Vital Signs 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 SpO signal or NIBP measurement.

  • Page 88: Chapter 13 Monitoring Nibp

    Vital Signs 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.

  • Page 89: Measurement Limitations

    Vital Signs Monitor User Manual Monitoring NIBP WARNING Measuring of blood pressure can temporarily cause malfunctioning of other medical monitoring devices on the same limb. NIBP readings can be affected by the measurement site, the position of the patient, exercise, or the patient's physiologic conditions. Continuous cuff pressure due to connection tubing kinking can block the blood flow, and may result in injury to the patient.

  • Page 90: Measurement Methods

    Vital Signs Monitor User Manual Monitoring NIBP Patients with rapid blood pressure changes. Patients with severe shock or hypothermia that reduces blood flow to the peripheries. Patients with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery.
  • Page 91 Vital Signs Monitor User Manual Monitoring NIBP right atrium of the heart and the cuff is completely deflated. Apply the appropriate size cuff to the patient (About the cuff size selection, please refer to Section NIBP accessories), and make sure that the symbol "Φ" is over the artery. Ensure that the cuff is not wrapped too tightly around the limb.

  • Page 92: Operation Prompts

    Vital Signs Monitor User Manual Monitoring NIBP 13.5.1 Operation Prompts 1. Manual Measuring Access the NIBP Setup > Function menu and set the Measure Mode item to Manual. Then press the button on the front panel to start a manual measurement. During measurement, pressing this button at any time can stop measurement.

  • Page 93: Correcting The Measurement If Limb Is Not At Heart Level

    13.7 Resetting NIBP Available for EDAN module only. When the pressure does not work properly and the system fails to give a message for the problem, pick Reset in the User Maintain > NIBP menu to activate self-test procedure, and thus restore the system from abnormal performance.

  • Page 94: Calibrating Nibp

    5. Select Leakage Test in NIBP. Then the prompt Leak. Test Running will appear indicating that the system has started the leakage test. For EDAN module: 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.

  • Page 95: Setting Inflation Value

    Vital Signs Monitor User Manual Monitoring NIBP pressure level again (P2). Safety circuitry on the module only allows the pressure in the pneumatic system to remain above 10mmHg for 180 seconds. When this safety time limit is exceeded, the valves will open releasing the pressure. Subtract P2 from P1 and this is the leak rate per minute.

  • Page 96: Chapter 14 Monitoring Temp

    14.1 Quick TEMP with T2A Module 14.1.1 Introduction iM3 with the T2A module takes a temperature in either Predict or Monitor Mode. In the Predict mode, the monitor measures oral/axillary/rectal TEMP in a short time, calculates and gets the measuring results. In Monitor mode, it can monitor patient for 10 min. The Oral/Axillary sensor and Rectal sensor are of standard configuration.

  • Page 97: Measuring Procedure

    Biting the sensor tip while taking a temperature may result in damage to the sensor. Use disposable TEMP sensor covers recommended by EDAN to limit patient cross-contamination. The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings.

  • Page 98: Temp Setup For T2A Module

    14.2 Quick TEMP with F3000 Module 14.2.1 Introduction iM3 with the F3000 module measures patient temperatures by oral, axillary or rectal means. The monitor can only measure temperature of adult and pediatric patients. If the user measure temperature of neonate patient, the monitor will not display data.
  • Page 99 Vital Signs Monitor User Manual Monitoring TEMP WARNING Do not use this device near flammable anesthetics. Not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. Do not use this thermometer without first installing a new probe cover. Do not reuse the disposable probe covers.

  • Page 100: Probe Covers -Applying & Removing

    Vital Signs Monitor User Manual Monitoring TEMP Hospital Procedures Policy. When you need to calibrate the temperature measurement, please contact the manufacturer. 3. The reference body site temperature is the same as the temperature of the measuring site. 4. The cumulative use time for the oral or rectal temperature probe in a single patient should be less than 24 hours.

  • Page 101: Measuring Mode

    Vital Signs Monitor User Manual Monitoring TEMP To change probes, remove the isolation chamber as described previously. Grasp the sides of the L-shaped connector piece with one hand and then using other hand pull backward on the latch holding the end of the L-shaped connector. Once free of the latch, slide the L-shaped connector out of isolation chamber.

  • Page 102: Measuring Procedure

    Vital Signs Monitor User Manual Monitoring TEMP 14.2.5 Measuring Procedure Oral and Axillary Temperature Taking Make certain that the Blue isolation chamber /probe unit is attached. Withdraw probe and apply a probe cover. The thermometer turns on automatically and a beep will be heard when the probe completes warm-up.

  • Page 103: Temp Setup For F3000 Module

    Vital Signs Monitor User Manual Monitoring TEMP If three short beeps are heard, it means the unit switched to Monitoring Mode for this temperature only. Two beeps are sounded when measurement is complete and the final temperature is displayed. 10. Eject the used cover into a bio-waste container by pushing top button. Rectal Temperature Taking Make certain that the Red isolation chamber/probe unit is attached.

  • Page 104: Infrared Temp With Th Module

    14.3 Infrared TEMP with TH Module 14.3.1 Introduction iM3 with the TH module (Infrared Ear Temperature Module) takes a temperature in the ear. Diagram of the Infrared Ear Thermometer: WARNING The infrared ear thermometer is not intended for neonatal patients.

  • Page 105: Measuring Procedure

    Vital Signs Monitor User Manual Monitoring TEMP CAUTION Keep the probe window clean, dry, and undamaged at times to ensure accurate measurements. To protect the probe window, always keep the thermometer in the storage cover while transporting or when not in use. Proper installation of the probe cover ensures accurate measurements.
  • Page 106 Vital Signs Monitor User Manual Monitoring TEMP NOTE: If the probe cover did not install well, the icon will flash on the LCD of the thermometer, and you cannot take the ear temperature (with four beep sounds heard and without reading on the LCD when measuring). Press ON/MEM button of the thermometer.

  • Page 107: Replacing The Battery

    Vital Signs Monitor User Manual Monitoring TEMP It is recommended that you measure the same ear for three times. If the three measurements are different, select the highest temperature. Remember to compare the measurement result to the regular temperature of the patient. There is no gender and age limitation for using infrared ear thermometer.
  • Page 108 Vital Signs Monitor User Manual Monitoring TEMP WARNING Keep the battery away from children. Ensure the positive (+) side is up and the negative (-) side down. - 100 -...

  • Page 109: Chapter 15 Warning-Score System

    Vital Signs Monitor User Manual Warning-Score System Chapter 15 Warning-Score System Click User Maintain > Score Type to turn on one of the warning-score function. User can use warning-score system to get score and sum up based on measurement value or input value of each vital sign.

  • Page 110: Warning-Score Criteria

    Vital Signs Monitor User Manual Warning-Score System 15.3 Warning-Score Criteria In EWS interface, select Criteria to check score criteria as following: Value HR (bpm) ≤40 41~50 51~100 101~110 111~129 ≥130 SYS (mmhg) ≤70 71~80 81~100 101~199 ≥200 RESP (rpm) ≤8 9~20 21~24 25~29...

  • Page 111: Warning-Score Result

    Vital Signs Monitor User Manual Warning-Score System The relationship between consciousness level and its display result is as below: Consciousness Displayed Result Sober Responsive to Voice Responsive to Pain Unresponsive 15.4 Warning-Score Result Warning-Score results include parameter value, score value, time and severity level. The relation for value and severity level is as following: Severity Warning-score Remindings...

  • Page 112: Warning-Score Trend Table

    Vital Signs Monitor User Manual Warning-Score System NEWS=5~6 Observing and checking should be taken every One single 1 hr at least. Or call the doctor to give Medium Amber parameter’s appropriate actions if necessary. score value=3 points Please inform medical personnel that urgent checking should be taken.

  • Page 113: Chapter 16 Storing Data In The Storage Device

    Vital Signs Monitor User Manual Storing Data in the Storage Device Chapter 16 Storing Data in the Storage Device 16.1 Setting Storage Mode (For Monitor Mode Only) NOTE: The storage time varies according to the patient's parameter data volume. When store time for single patient data reaches 240 hours, the monitor will create a new folder for continuous data store.

  • Page 114: Reviewing Data Stored In The Storage Device

    The power supply is off. CAUTION Not all the removable devices are compatible with the monitor, Use the removable devices recommended by EDAN. Do not set the read-only switch on the removable device to on when the removable device is inserted in the monitor.

  • Page 115: Exporting Data Stored In The Internal Storage Device

    Vital Signs Monitor User Manual Storing Data in the Storage Device In monitor mode: To delete data of one patient, choose the patient from the list after selecting Menu > Review > History Patient, and then click Delete data on the Review menu. Further confirmation of deletion is required.

  • Page 116: Recording Data By Recorder

    Vital Signs Monitor User Manual Storing Data in the Storage Device 16.7 Recording Data by Recorder In monitor mode: To recording the review data, please enter Menu> Review > History Patient > choose one patient data in history patient window > Review > choose your desired data to review > Record. The data to be recorded include: trend graph, trend table, NIBP review and alarm review.

  • Page 117: Chapter 17 Recording

    Vital Signs Monitor User Manual Recording Chapter 17 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. Recording indicator Paper feeding key: press this key to start or stop feeding recording paper without outputting anything on the paper Paper outlet Recorder door...
  • Page 118 Vital Signs Monitor User Manual Recording Recording Type Description/ Procedure Continual real-time In monitor mode, enter Menu > System Setup > Recorder, select recording Continual in R-T Rec Time, and press Record shortcut key to start or stop recording. 8-second real-time In monitor mode, select 8 s in R-T Rec Time, set Record Interval as recording...

  • Page 119: Recorder Operations And Status Messages

    Vital Signs Monitor User Manual Recording The recorder will stop recording in the following situations: The recording task is finished. No paper in the recorder. Malfunction stops the recorder from running properly. The monitor enters Standby mode. NOTE: You can also use the Record shortcut key to manually start or stop recording. 17.3 Recorder Operations and Status Messages 17.3.1 Record Paper Requirement Only standard thermosensitive record paper can be used: otherwise the recorder may not function,...

  • Page 120: Removing Paper Jam

    Vital Signs Monitor User Manual Recording 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. NOTE: Be careful when inserting papers.

  • Page 121: Chapter 18 Using Battery

    Vital Signs Monitor User Manual Using Battery Chapter 18 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.

  • Page 122: Battery Power Indicator

    Vital Signs Monitor User Manual Using Battery WARNING When the monitor is running on battery power, do not replace the battery during monitoring patients; or the monitor will be powered off, which may result in patient injury. Do not place battery in the monitor with the (+) and (-) in the wrong way. For the monitor equipped with dual batteries, if the battery temperature is too high during the charging process, the monitor will automatically stop charging.

  • Page 123: Replacing The Battery

    Vital Signs Monitor User Manual Using Battery recommended here can help to slow down this process. 1. Disconnect the patient from the monitor and stop all monitoring and measurement. 2. Switch the monitor power on and fully charge the battery. 3.
  • Page 124 Vital Signs Monitor User Manual Using Battery charging the battery for a longer period of time. It is recommended to check and maintain the batteries regularly every 3-6 months if they are not in use for a long time. And recharge the batteries to 40%~60% every 3-6 months when they are stored.

  • Page 125: Chapter 19 Care And Cleaning

    Vital Signs Monitor User Manual Care and Cleaning Chapter 19 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.

  • Page 126: Cleaning

    CAUTION If you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or EDAN service engineer. 19.3 Cleaning If the device or accessory has been in contact with the patient, then cleaning and disinfection is required after every use.

  • Page 127: Cleaning The Reusable Accessories

    Vital Signs Monitor User Manual Care and Cleaning If the monitor is not visually clean at the end of the cleaning steps, please repeat the cleaning steps through step 4 to step 7. Inspect the monitor to ensure that there is no damage. 19.3.2 Cleaning the Reusable Accessories 19.3.2.1 Cleaning the Blood Pressure Cuff Cleaning the Cuff:...

  • Page 128: Disinfection

    Vital Signs Monitor User Manual Care and Cleaning After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains. Wipe off residual moisture with a dry cloth. Leave the sensor to air dry. If the SpO Sensors, including cables, are not visually clean at the end of the cleaning steps, please repeat the cleaning steps through step 4 to step 6.

  • Page 129: Disinfecting The Monitor

    Vital Signs Monitor User Manual Care and Cleaning CAUTION 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. Although the monitor chemically resistant to most common hospital cleaners, disinfectants and non-caustic detergents, unverified cleaners or disinfectants are not recommended and may stain the monitor, such as disinfectant didecyl dimethyl ammonium bromide which contains quaternary ammonium salt.

  • Page 130: Disinfecting The Reusable Accessories

    Vital Signs Monitor User Manual Care and Cleaning 19.4.2 Disinfecting the Reusable Accessories 19.4.2.1 Disinfecting the Blood Pressure Cuff Disinfecting the Cuff: Disassemble NIBP Cuff from the monitor, and take out the air bladder. Clean and dry the NIBP Cuff and air bladder according to the methods in section 19.3.2.1 prior to disinfection.

  • Page 131: Cleaning And Disinfecting Other Accessories

    Vital Signs Monitor User Manual Care and Cleaning Disassemble quick TEMP module from the monitor. Clean and dry the TEMP Sensor according to the methods in section 19.3.2.3 prior to disinfection. Prepare the disinfectant solution. Wipe the sensor with a soft cloth dampened with the disinfectant solution (ethanol or isopropanol).

  • Page 132: Chapter 20 Maintenance

    The maintenance operations like software upgrade of the device can only be completed by EDAN-qualified service professionals. The history data in monitor may be deleted due to software upgrade. Before software upgrade, please backup the data in the monitor to avoid data loss. For data backup methods, please refer to the section Exporting Data Stored in the Internal Storage Device to export the data, or refer to the section Uploading Data to Network Server to load the data to HIS system.

  • Page 133: Maintenance Task And Test Schedule

    Maintenance shall be carried out at least once every two years, or as specified by local regulations. The following tasks are for EDAN-qualified service professionals only. Contact an EDAN-qualified service provider if your monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it.

  • Page 134: Chapter 21 Warranty And Service

    EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired.

  • Page 135: Chapter 22 Accessories

    Vital Signs Monitor User Manual Accessories Chapter 22 Accessories You can order accessories from EDAN supplies at www.edan.com.cn or consult your local EDAN representative for details. WARNING 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.

  • Page 136: Nibp Accessories

    Nellcor sticking sensor, Infant, 3 kg-20 kg, foot, MAX-I 01.57.040445 Nellcor sticking sensor, Pediatric, 10 kg-50 kg, hand, MAX-P 22.2 NIBP Accessories Part Number Accessories For EDAN Module 01.57.471326 NIBP Cuff, Infant E5, 10 cm-15 cm, reusable 01.57.471327 NIBP Cuff, Small child E6, 13 cm-17 cm, reusable 01.57.471328 NIBP Cuff, Child E7, 16 cm-21.5 cm, reusable...

  • Page 137: Temp Accessories

    Vital Signs Monitor User Manual Accessories Part Number Accessories 01.57.471324 NIBP Cuff, Neonate, 6 cm-11 cm, reusable 01.57.471157 NIBP Cuff, neonatal #1, 3 cm-6 cm,disposable 01.57.471158 NIBP Cuff, neonatal #2, 4 cm-8 cm,disposable 01.57.471159 NIBP Cuff, neonatal #3, 6 cm-11 cm,disposable 01.57.471160 NIBP Cuff, neonatal #4, 7 cm-13 cm,disposable 01.57.471161...

  • Page 138: Other Accessories

    Vital Signs Monitor User Manual Accessories 02.01.110130 Temperature Probe, Rectal, FT20 01.57.471871 Disposable Probe Covers TEMP (For TH Module) 01.13.036415 Infrared Ear Thermometer Communication Cable 01.57.208057 Infrared Ear Thermometer 01.57.208058 Probe Cover 01.57.208059 Probe Cover Loader TEMP (For F3000 Module) 01.57.471312 Filac 3000 Oral Probe 4ft 01.57.471313...
  • Page 139 Vital Signs Monitor User Manual Accessories Part Number Accessories 01.23.068023 Linear Barcode Scanner 02.04.241690 Patient monitor mounting arm assembly kit (M3/iM50) 02.04.101976 Rolling Stand Basket (in the bottom) 83.60.261069 M3\iM50 Trolley, metal caster 83.60.261116 M3\iM50 Trolley, plastic caster 83.60.261648 MT-206 (S) Trolley 02.04.241699 Patient monitor mounting arm assembly kit (M3/iM50) 01.13.037122...

  • Page 140: A Product Specification

    Vital Signs 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 , NIBP, TEMP: BF Ingress Protection IPX1 With T2A, TH or F3000 TEMP module: Ordinary...

  • Page 141: Display

    Vital Signs Monitor User Manual Product Specification • When charging the monitor which is equipped with dual batteries: +0 °C to +30 °C (32 ℉~86 ℉) -20 °C to +55 °C(-4 ℉~131 ℉) Transport and Storage With TH TEMP module: -20 °C ~ +50 °C (-4 ℉~122 ℉) Humidity Working 15%RH ~ 95%RH (non-condensing)

  • Page 142: Recorder

    Vital Signs Monitor User Manual Product Specification Number Capacity ≥4800 mAh Standard configuration, at 20 °C~30 °C, with (a) new fully Condition charged battery/batteries, continuous SpO measurement and NIBP automatic measurement mode at interval of 15 minutes, recording at interval of 10 minutes Operating Time ≥8 hrs ≤20 hrs, at 20 °C~30 °C;...

  • Page 143: Nibp

    In spot-checking mode, storage data maximally contains the following information: 16 million sets of spot-checking data for multiple patients. A.3 NIBP Complies with IEC 80601-2-30: 2009+A1: 2013. EDAN Module Technique Oscillometry Mode Manual, Auto, Continuous, Average Measuring Interval in AUTO...
  • Page 144 Vital Signs Monitor User Manual Product Specification SYS: 40 mmHg to 270 mmHg ☆Adult Mode DIA: 10 mmHg to 215 mmHg MAP: 20 mmHg to 235 mmHg SYS: 40 mmHg to 230 mmHg ☆Pediatric Mode DIA: 10 mmHg to 180 mmHg MAP: 20 mmHg to 195 mmHg SYS: 40 mmHg to 135 mmHg ☆Neonatal Mode...
  • Page 145 Vital Signs Monitor User Manual Product Specification SunTech Module Method Oscillometric Mode Manual, Auto, Continuous, Average Measuring Interval in AUTO Mode 1/2/3/4/5/10/15/30/60/90/120/180/240/360/480 (unit: minute) Continuous 5 min, interval is 5 s Average measurement Interval (unit: minutes) 1/2/3/4/5 times SYS, DIA, MAP, PR ☆Measuring Parameter ☆Measuring Range SYS: 40 mmHg ~ 260 mmHg...

  • Page 146: Spo

    Neonatal Mode 60 mmHg, 70 mmHg, 80 mmHg, 90 mmHg, 100 mmHg, 120 mmHg, 140 mmHg Default: 90 mmHg A.4 SpO Complies with ISO 80601-2-61: 2017. EDAN Module Measuring Range 0% to 100% Resolution ☆Data Update Period ☆Accuracy ±2% (70% to 100% SpO ☆Adult /Pediatric...
  • Page 147 A.5 PR Measuring range Accuracy Resolution ±2 bpm PR (SpO EDAN 25 bpm to 300 bpm 1 bpm ±3 bpm (20 bpm to 250 bpm) Nellcor 20 bpm to 300 bpm 1 bpm PR (NIBP)

  • Page 148: Temp

    Vital Signs Monitor User Manual Product Specification A.6 TEMP Complies with ISO 80601-2-56: 2017+A1:2018. T2A Module: Monitor mode: 25 °C~45 °C ☆Measuring range Predict mode: 35.5 °C~42 °C 10 °C ~40 °C Working temperature Transport and Storage -20 °C ~ 55 °C Sensor type Oral /axillary /rectal 35.5 °C ~42 °C...
  • Page 149 Vital Signs Monitor User Manual Product Specification Measuring Mode Adjusted Mode ±0.2 °C (0.4 °F) (35.5 °C ~42 °C) (95°F ~107.6°F) Clinical Accuracy ±0.3 °C (0.5°F) (out of the range mentioned above) ±0.2 °C Laboratory Accuracy F3000 Module: 30 °C~43 °C ☆Measuring range 35 °C~43 °C Prediction measurement range...

  • Page 150: Adjustable Range Of Alert Limits

    Vital Signs Monitor User Manual Product Specification A.7 Adjustable Range of Alert Limits 20% ~ 100% 30 bpm ~ 300 bpm NIBP mmHg EDAN NIBP Patient Type High Limit Low Limit SunTech NIBP Patient Type High Limit Low Limit TEMP...

  • Page 151: Wi-Fi

    Vital Signs Monitor User Manual Product Specification A.8 Wi-Fi IEEE 802.11a/b/g/n Frequency Band 2.4 GHz & 5 GHz ISM band Modulation OFDM with BPSK, QPSK, 16-QAM, and 64-QAM 802.11b with CCK and DSSS Max. Transmit Power 2.4 GHz 17 dBm for 802.11b DSSS (±2 dBm) 17 dBm for 802.11b CCK 17 dBm for 802.11g OFDM...

  • Page 152: Interfaces

    Vital Signs Monitor User Manual Product Specification A.10 Interfaces A.10.1 Nurse Call Drive Mode Voltage output Power Supply 3.14 V ~ 3.46 V, 8 mA MAX Interface Signal 3.3 V power supply and PWM waveform Interface Type Micro USB A.10.2 USB Interfaces Number of USB Interfaces Standard:1 Drive Mode...

  • Page 153: B Emc Information

    B.1 Electromagnetic Emissions Guidance and manufacture’s declaration – electromagnetic emission iM3 is intended for use in the electromagnetic environment specified below. The customer or the user of iM3 should assure that they are used in such an environment. Emission test Compliance Electromagnetic environment –...
  • Page 154 135°, 180°, 225°, 315° on power supply hospital environment. If 270° and 315° input lines the user of iM3 requires continued operation IEC/EN 0 % UT; 1 cycle 0 % U ; 1 cycle during...

  • Page 155: Electromagnetic Immunity

    B.3 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity iM3 is intended for use in the electromagnetic environment specified below. The customer or the user of iM3 should assure that they are used in such an environment. IEC/EN 60601 test...
  • Page 156 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which iM3 is used exceeds the applicable RF compliance level above, iM3 should be observed to verify normal operation.

  • Page 157: Recommended Separation Distances

    Recommended separation distances between portable and mobile RF communications equipment and iM3 iM3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of iM3 can help prevent electromagnetic interference...
  • Page 158 Vital Signs Monitor User Manual EMC Information Rated maximum Separation distance according to frequency of transmitter(m) output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz transmitter 0.01 0.12 0.12 0.23 0.38 0.38 0.73 For transmitters rated at a maximum output power not listed above, the recommended...

  • Page 159: C Default Settings

    Vital Signs 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.

  • Page 160: Pr Default Settings

    Alarm Level Medium Alarm High Limit (SYS) Alarm Low Limit (SYS) Alarm High Limit (MAP) Alarm Low Limit (MAP) Alarm High Limit (DIA) Alarm Low Limit (DIA) EDAN Module Inflation value SunTech Module Inflation value Unit mmHg Interval (Auto) 1 minute...

  • Page 161: Temp Default Settings

    Vital Signs Monitor User Manual Default Settings Auto Recording Alert Switch Alert High Limit（SYS） Alert Low Limit（SYS） Alert High Limit（MAP） 110 Alert Low Limit（MAP） Alert High Limit（DIA） Alert Low Limit（DIA） C.6 TEMP Default Settings TEMP Settings Alarm Switch Alarm Record Alarm Level Medium Measurement Mode...

  • Page 162: D Abbreviations

    Vital Signs Monitor User Manual Abbreviations D Abbreviations Abbr English Full Name/Description Alternating current Adult Arterial Blood pressure BTPS Body temperature and pressure, saturated Cardiac index CISPR International Special Committee on Radio Interference Central monitoring system COHb Carboxyhemoglobin Direct current Diastolic European Economic Community Electromagnetic compatibility...
  • Page 163 Vital Signs Monitor User Manual Abbreviations Abbr English Full Name/Description Magnetic resonance imaging Not applied Neonate NIBP Non-invasive blood pressure Oxygen Pediatric Pleth Plethysmogram Pulse rate Premature ventricular complex Right Right arm Right atrial pressure Reduced hemoglobin Right leg Respiration Rate Sevoflurane Systolic pressure Blood Temperature...

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