EDAN M3 User Manual
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EDAN M3 User Manual

Vital signs monitor
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About this Manual
P/N: 01.54.109395-16
Release Date: January 2012
© Copyright EDAN INSTRUMENTS, INC. 2008-2012. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User's operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.
I

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Summary of Contents for EDAN M3

  • Page 1 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) can not be held liable.
  • Page 2 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 3: Table Of Contents

    Table of Contents Chapter 1 Intended Use and Safety Guidance ................1 1.1 Intended Use...........................1 1.2 Safety Guidance ........................1 1.2.1 Environment........................1 1.2.2 Power Source Requirements ..................1 1.2.3 Grounding the Monitor ....................1 1.2.4 Equipotential Grounding.....................2 1.2.5 Condensation.......................2 1.2.6 Safety Precautions.......................2 1.2.7 Explanation of Symbols on the Monitor ..............5 Chapter 2 Installation of Monitor ....................7 2.1 Opening the Package and Checking..................7 2.2 Connecting the Power Cable....................7...
  • Page 4 4.8 NIBP Setup...........................34 4.9 TEMP Setup .........................35 4.10 Alarm Setup........................35 4.11 Maintain ..........................36 4.12 Data Storing ........................42 4.13 Sleep Mode.........................46 Chapter 5 Alarm..........................47 5.1 Alarm Modes........................47 5.1.1 Alarm Level.......................47 5.1.2 Alarm Modes......................47 5.1.3 Alarm Setup.......................49 5.2 Alarm Cause .........................50 5.3 Silence ..........................50 5.4 Parameter Alarm........................51 5.5 When an Alarm Occurs ......................51 5.6 Testing Alarms........................51...
  • Page 5 9.2 NIBP Safety Information .....................65 9.3 NIBP Monitoring........................66 9.4 NIBP Setup Menu ........................69 9.4.1 NIBP Setup........................69 9.4.2 NIBP Unit Setup......................70 9.4.3 NIBP Alarm Setup.....................71 9.5 NIBP Alarm Message and Prompt Message ................73 9.6 Maintenance and Cleaning....................75 Chapter 10 TEMP Monitoring (Optional) ..................77 10.1 TEMP Monitoring with T2 Module ...................77 10.1.1 Introduction ......................77 10.1.2 Measuring Procedure ....................78...
  • Page 6 A1.2.6 Review........................99 A1.2.7 NIBP (Optional) .....................99 A1.2.8 SpO (Optional)....................100 A1.2.9 TEMP (Optional)....................102 A1.2.10 Wirless Network....................102 Appendix EMC Information - Guidance and Manufacture’s Declaration ......104 A2.1 Electromagnetic Emissions - For all EQUIPMENT and SYSTEMS ......104 A2.2 Electromagnetic Immunity - For all EQUIPMENT and SYSTEMS ......104 A2.3 Electromagnetic Immunity - For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING........................106 A2.4 Recommended Separation Distances ................107...

  • Page 7: Chapter 1 Intended Use And Safety Guidance

    M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use The Vital Signs Monitor (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).

  • Page 8: Equipotential Grounding

    Only qualified service engineers can install this equipment. And only service engineers authorized by EDAN can open the shell. EXPLOSION HAZARD-Do not use the monitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.
  • Page 9 Keep it away from the monitor. 16 Do not use a battery with serious scar or deformation. 17 Only patient cable and other accessories supplied by EDAN can be used. Or else, the performance and electric shock protection can not be guaranteed, and the patient may be injured.
  • Page 10 M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING 23 When the monitor and electrosurgical device are used together, the user (physician or nurse) should guarantee the safety of patient. 24 Please disinfect timely to prevent cross infection between patients.

  • Page 11: Explanation Of Symbols On The Monitor

    M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance CAUTION 11 If the monitor gets damp, put it in dry circumstance to dry it until it can work normally. If liquid pours on the monitor, please contact the service personnel authorized by EDAN.
  • Page 12 M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance Caution Consult Instructions for Use Equipotentiality Stand-by. It designates that the switch or switch position which one part of the monitor has been switched on, while the monitor is at the status of stand-by.

  • Page 13: Chapter 2 Installation Of Monitor

    M3 Vital Signs Monitor User Manual Installation of Monitor Chapter 2 Installation of Monitor NOTE: To ensure that the monitor works properly, please read Chapter1 Intended Use and Safety Guidance, and follow the steps before using the monitor. 2.1 Opening the Package and Checking Visually examine the package prior to unpacking.

  • Page 14: Connecting Sensor To Patient

    M3 Vital Signs Monitor User Manual Installation of Monitor NOTE: Check all the functions of the monitor and make sure that the monitor is in good condition. If rechargeable batteries are provided, recharge them after using the monitor every time to ensure the electric power is enough.

  • Page 15: Chapter 3 Introduction

    M3 Vital Signs Monitor User Manual Introduction Chapter 3 Introduction 3.1 General Information The monitor integrates the function of parameter measurement modules, display, recording and output to compose a compact, portable device. Its built-in replaceable battery provides convenience for patient movement. On the LCD display screen, SpO waveform and all the monitoring parameters can be displayed clearly.

  • Page 16: Screen Display

    M3 Vital Signs Monitor User Manual Introduction The monitor provides extensive functions such as visual and audible alarms, recording and storage for trend data, SpO /NIBP/TEMP measurements review, net connection, nurse call, alarm events and so on. Recording and mobile storage are optional functions for monitor.
  • Page 17 M3 Vital Signs Monitor User Manual Introduction The Waveform area can display parameter trend list or alarm list. It displays as follows: Figure 3-3 Main display with alarm list The display on the screen can be changed to a trend graph as follows:...
  • Page 18 M3 Vital Signs Monitor User Manual Introduction The icons on the interface and their meanings are as follows: Battery status indicator Connected to mains power supply Network connection indicator Network connection off Medium/Low alarm High alarm icon Audio system off...
  • Page 19 M3 Vital Signs Monitor User Manual Introduction Measuring oral TEMP in ADU mode Measuring axillary TEMP in ADU mode For device with the T2 TEMP module Measuring rectal TEMP in ADU mode only. Measuring oral TEMP in PED mode Measuring axillary TEMP in PED mode...

  • Page 20: Double-Parameter Mode

    M3 Vital Signs Monitor User Manual Introduction including the following data: ⎯ Patient type and ID; ⎯ NIBP measuring mode; ⎯ Signs indicating the net connection status; ⎯ Signs indicating the battery or mains power supply status; ⎯ Current time;...
  • Page 21 M3 Vital Signs Monitor User Manual Introduction Figure 3-6 SpO as the Main Parameter NIBP+TEMP Interface Figure 3-7 NIBP+TEMP Interface - 15 -...

  • Page 22: Single Parameter Mode

    M3 Vital Signs Monitor User Manual Introduction 3.2.3 Single Parameter Mode only measuring mode Figure 3-8 Display in SpO only mode - 16 -...
  • Page 23 M3 Vital Signs Monitor User Manual Introduction NIBP only measuring mode In NIBP only measuring mode, the PR from NIBP measurement is also displayed on screen. Figure 3-9 Display in NIBP only mode - 17 -...

  • Page 24: Button Functions

    M3 Vital Signs Monitor User Manual Introduction 3.3 Button Functions Figure 3-10 Buttons All the operations to the monitor can be finished by several buttons. ON/OFF When the monitor is off, press this button to switch on the monitor. When the monitor is on, press this button and ①...
  • Page 25 M3 Vital Signs Monitor User Manual Introduction NIBP START/STOP To inflate the cuff and start blood measuring. During the measuring process, press the button to stop measuring. (For the monitor with NIBP function). ③ ALARM LIMIT For SpO only monitor, the NIBP STASRT/STOP button is changed to ALARM LIMIT button.

  • Page 26: Interfaces

    M3 Vital Signs Monitor User Manual Introduction 3.4 Interfaces For the convenience of operator, interfaces of different functions are in different sites of the monitor. There is a USB port on rear panel for Data storing function. Left side of the monitor...
  • Page 27 M3 Vital Signs Monitor User Manual Introduction With T2 TEMP Module: T2 TEMP thermometer T2 TEMP thermometer housing With Intrared Ear Temperature Module: TH TEMP thermometer TH TEMP thermometer holder Figure 3-12 Right Panel - 21 -...
  • Page 28 ① Equipotential grounding terminal for connection with the hospital’s grounding system. ② Power supply socket: 100V–240V ~, 50Hz/60Hz. ③ USB connecting port for USB storage. ④ Network Interface: Standard RJ45 Socket, for connecting to MFM-CMS of EDAN. Bottom panel There are battery compartment and fuse box on the bottom panel.

  • Page 29: Built-In Rechargeable Battery

    M3 Vital Signs Monitor User Manual Introduction Battery compartment cover Fuse box Figure 3-14 Bottom panel 3.5 Built-in Rechargeable Battery The monitor is equipped with a built-in rechargeable battery. When switching on AC power supply, the battery will be recharged automatically until full electric energy. There is a sign in the bottom right corner of screen.
  • Page 30 M3 Vital Signs Monitor User Manual Introduction WARNING Do not take off the battery when monitoring. The unexpected power supply off can not impact the monitor normal working, if it has battery for standby. Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal condition is detected during use, recharge, or storage.

  • Page 31: Chapter 4 System Menu

    M3 Vital Signs Monitor User Manual System Menu Chapter 4 System Menu The monitor features in flexible configurations. You can configure various aspects of the monitor, including the parameters to be monitored, audio signal volume, and output content. Press MENU on the front panel to open SYSTEM MENU. You can perform the following operations in this menu.

  • Page 32: Default Setup

    M3 Vital Signs Monitor User Manual System Menu PAT TYPE: Patient type; ADU, PED, or NEO. Press the UP/DOWN button on the front panel to select the items; then press the OK button to confirm. Pick EXIT to return to the previous menu.
  • Page 33 M3 Vital Signs Monitor User Manual System Menu Figure 4-4 System Setup ALARM VOL: Set alarm volume to HIGH, MED or LOW. STANDBY: Set it to ON or OFF to enable or disable the Sleep Mode function (Refer to 4.12 Sleep Mode).

  • Page 34: Selection

    M3 Vital Signs Monitor User Manual System Menu 4.4 Selection For the monitor outfitted with SpO , NIBP and TEMP modules, you may select SELECTION in SYSTEM MENU to access this submenu, in which six selections are available: NIBP TREND...
  • Page 35 M3 Vital Signs Monitor User Manual System Menu TREND TAB: to display SpO trend table; Figure 4-7 SpO Trend Table TEMP TREND TAB: to display TEMP trend table; Figure 4-8 SpO Trend Table - 29 -...
  • Page 36 M3 Vital Signs Monitor User Manual System Menu ALARM LIST: to display alarm list. Figure 4-9 Alarm List TREND GRAPH: to display the trend graph. Figure 4-10 Trend Graph - 30 -...
  • Page 37 M3 Vital Signs Monitor User Manual System Menu PARAMETER TAB: to display SpO and NIBP parameters in the area; Figure 4-11 Parameter Table You can shift the data list to waveform display by pressing the TREND/WAVEFORM button on front panel. The waveform displays as shown in the following figure.
  • Page 38 M3 Vital Signs Monitor User Manual System Menu Figure 4-12 Waveform Display For Single display mode, the Selection menus are different, see the following menu: Figure 4-13 Selection for SpO - 32 -...

  • Page 39: Deleting Data

    M3 Vital Signs Monitor User Manual System Menu Figure 4-14 Selection for NIBP 4.5 Deleting Data If you press the button when a trend list or an alarm list is displayed onscreen, the following menu will pop up: Figure 4-15 Delete Data DELETE ID: Entirely delete the trend and alarm data of the current monitored patient.

  • Page 40: Nibp Setup

    M3 Vital Signs Monitor User Manual System Menu day, hour, minute and second. Pick the item you want to modify and confirm it by pressing OK. Select EXIT item to save the setup and return to the previous menu. If you want to exit the menu without saving it, press the MENU on front panel.

  • Page 41: Temp Setup

    M3 Vital Signs Monitor User Manual System Menu 4.9 TEMP Setup Click on TEMP SETUP in SYSTEM MENU to open the following menu: Figure 4-18 TEMP Setup MEASURE MODE: Set this item to PREDICT or MONITOR. MEASURE POS: Set this item to ORAL, AXILLARY or RECTA. The axillary sensor can be used for measuring oral/axillary temperature, while the rectal sensor for measuring rectal temperature.

  • Page 42: Maintain

    Select MAINTAIN item in SYSTEM MENU to open ENTER MAINTAIN PASSWORD dialog box, in which you can enter password and then customize maintenance settings. Factory maintenance function is only available for the service engineers of EDAN or representative authorized by EDAN.
  • Page 43 SERVER IP: The default server IP is 202.114.4.119. It can be changed by the user according to the IP of PC installed with MFM-CMS of EDAN. SERVER PORT: Set server port. PRES UNIT: Set the pressure unit to mmHg or kPa.
  • Page 44 M3 Vital Signs Monitor User Manual System Menu COLOR SELECT: Set the color of displayed waveforms. 16 kinds of colors can be selected. Click on DEFAULT to return to the default configuration. Figure 4-22 Color Select OTHER SETUP SETUP: Access SpO...
  • Page 45 M3 Vital Signs Monitor User Manual System Menu NIBP SETUP: Access NIBP SETUP and you can see the menu as follows: Figure 4-24 NIBP Setup RESET: Select it to reset the NIBP module. - Restore measurement status. - Pick this item to restore initial settings of the pressure pump.
  • Page 46 M3 Vital Signs Monitor User Manual System Menu of the monitor will not exceed 3 mmHg. Otherwise, please contact our customer service. Figure 4-25 NIBP Calibration LEAK TEST This item is used for an air leakage test. Select this item to start the air leakage test. Then the item will change into STOP LEAK TEST.
  • Page 47 M3 Vital Signs Monitor User Manual System Menu Figure 4-26 Diagram of NIBP Air Leakage Test NIBP MEMORY You can set this item to ON or OFF. If the item is ON, the monitor will automatically memorize the initial measurements of the patient when measuring his or her blood pressure.

  • Page 48: Data Storing

    EXIT: Exit the menu. Factory Maintain Factory maintenance function is only available for the service engineers of EDAN or representative authorized by EDAN. 4.12 Data Storing The monitor can support the USB storage for the Data Store function. Enter the menu by SYSTEM MENU >...
  • Page 49 M3 Vital Signs Monitor User Manual System Menu Figure 4-27 Data Store ON/OFF: set the Data Store function to ON or OFF. WARNING If you want to stop the data storing function, you should set this item to OFF before unplugging the USB disk.
  • Page 50 M3 Vital Signs Monitor User Manual System Menu Figure 4-28 Data Browser DELETE ALL: select this item to delete all the data stored before. The following dialog box displays: Figure 4-29 Data Browser Select YES to delete all the data.
  • Page 51 M3 Vital Signs Monitor User Manual System Menu RETURN: select this item to return to the previous menu. Select the single item data in DATA BROWSER menu, press OK to display the following menu: Figure 4-31 Menu The user can select to browse TREND TABLE or ALARM LIST of NIBP, or select to browse the TREND TABLE, TREND GRAPH or ALARM LIST of SpO .

  • Page 52: Sleep Mode

    M3 Vital Signs Monitor User Manual System Menu The data which is being stored can not be browsed in real time. Before searching data, you should turn off the Data Store function at first. 4.13 Sleep Mode Entering the Sleep Mode Select SYSTEM MENU >SYSTEM SETUP >STANDBY and configure the item to ON.

  • Page 53: Chapter 5 Alarm

    M3 Vital Signs Monitor User Manual Alarm Chapter 5 Alarm This chapter gives general information about the alarm and measures to be taken accordingly. Alarm setup and prompt messages are provided in respective parameter setup sections. WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area, e.g.
  • Page 54 M3 Vital Signs Monitor User Manual Alarm NOTE: The concrete presentation of each alarm prompt is related to the alarm level. Screen Display When the measured parameter exceeds its alarm limits and triggers a physiological alarm, the monitor will give alarm prompt on the screen indicating the occurrence of alarm.

  • Page 55: Alarm Setup

    M3 Vital Signs Monitor User Manual Alarm The sound pressure range for audible alarm signals is from 45 dB to 85 dB. 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.

  • Page 56: Alarm Cause

    M3 Vital Signs Monitor User Manual Alarm For example: Method to set systolic blood pressure alarm limit for SYS alarm: Step 1: Set the SYS alarm to ON; Step 2: Select the ALM HI (higher alarm limit of SYS), ALM LO (lower alarm limit of SYS).

  • Page 57: Parameter Alarm

    M3 Vital Signs Monitor User Manual Alarm Press the SILENCE button for more than 2s, the audio system is turned off, including the audible alarm, key volume and pulse tone. Pressing SILENCE again can turn on the audio system. 5.4 Parameter Alarm...

  • Page 58: Chapter 6 Trend And Recording

    M3 Vital Signs Monitor User Manual Trend and Recording Chapter 6 Trend and Recording The monitor provides 72-hour trend data of all parameters (SYS, MAP, DIA, PR, SpO ), storage of 30, 000 NIBP measurement results, 5-hour SpO waveform and 800 alarm events.
  • Page 59 M3 Vital Signs Monitor User Manual Trend and Recording Inserting Paper Pull outwards the upper arc part of the recorder casing to release the casing. Insert a new roll of paper into the paper cassette, printing side facing upwards. Ensure proper position and tidy margin.

  • Page 60: Chapter 7 Maintenance/ Cleaning

    If you find any damage on the monitor, stop using the monitor on patient, and contact the biomedical engineer of the hospital or EDAN immediately. The overall check of the monitor, including the safety check, should be performed only by qualified personnel once every 24 months, and each time after fixing up.

  • Page 61: Sterilization

    M3 Vital Signs Monitor User Manual Maintenance/ Cleaning CAUTION Do not let the cleaning agent enter into the chassis of the system. Do not leave the cleaning agents at any part of the equipment. The monitor, cables and accessories must be kept dust-free.

  • Page 62: Disinfection

    M3 Vital Signs Monitor User Manual Maintenance/ Cleaning CAUTION Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest effective concentration. Do not let liquid enter the monitor. No part of this monitor can be subjected to immersion in liquid.

  • Page 63: Cleaning Battery And Battery Compartment Cover

    M3 Vital Signs Monitor User Manual Maintenance/ Cleaning 7.6 Cleaning Battery and Battery Compartment Cover Use only non-caustic detergents such as soap and warm water (40℃/104℉ maximum) to clean the battery. Do not use strong solvent to clean battery, and do not dip the battery in liquid.

  • Page 64: Chapter 8 Spo 2 Monitoring (Optional)

    M3 Vital Signs Monitor User Manual Monitoring (Optional) Chapter 8 SpO Monitoring (Optional) 8.1 What is SpO Monitoring The monitor uses oximetry to measure functional oxygen saturation in the blood. SpO Plethysmogram measurement is employed to determine the functional oxygen saturation of hemoglobin in the arterial blood.

  • Page 65: Precautions During Spo /Pulse Monitoring

    M3 Vital Signs Monitor User Manual Monitoring (Optional) 8.2 Precautions during SpO /Pulse Monitoring WARNING Verify sensor cable fault detection before beginning of monitoring phase. Unplug the sensor cable from the socket, the screen will display the error message SpO SENSOR OFF and the audible alarm is activated.

  • Page 66: Limitations Of Measurement

    M3 Vital Signs Monitor User Manual Monitoring (Optional) Figure 8-1 Mounting of the Sensor 8.4 Limitations of Measurement In operation, the accuracy of oximetry readings can be affected by: High-frequency electrical noise, including noise created by the host system, or noise from external sources, such as electrosurgical apparatus, which is admitted by the host system.
  • Page 67 M3 Vital Signs Monitor User Manual Monitoring (Optional) Figure 8-2 Alarm setup In the menu, the alarm for SpO or PR can be turned on or off, and the alarm limits can be adjusted. Select ON to enable alarm during SpO monitoring;...

  • Page 68: Alarm Description

    M3 Vital Signs Monitor User Manual Monitoring (Optional) Default PR alarm limits: Max. Upper Limit Min. Lower Limit Step / PR alarm range: Parameter Max. Upper Limit Min. Lower Limit Step 8.6 Alarm Description Tables below describe the possible physiological alarms, technical alarms occurring during SpO measurement.

  • Page 69: Maintenance And Cleaning

    M3 Vital Signs Monitor User Manual Monitoring (Optional) Technical alarms: Alarm Message Cause What to do Level Make sure the sensor is The SpO sensor may be High/ Low attached to the patient’s SENSOR OFF disconnected from (Configured finger another patient.
  • Page 70 M3 Vital Signs Monitor User Manual Monitoring (Optional) For cleaning: Use a cotton ball or a soft mull moistened with hospital-grade ethanol to wipe the surface of the sensor, and then dry it with a cloth. This cleaning method can also be applied to the luminotron and receiving unit.

  • Page 71: Chapter 9 Nibp Monitoring (Optional)

    M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) Chapter 9 NIBP Monitoring (Optional) 9.1 Overview This monitor uses the oscillometric method for measuring NIBP. It can be used for adult, pediatric and neonatal patients. Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure.

  • Page 72: Nibp Monitoring

    M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) NOTE: The equipment is suitable for use in the presence of electrosurgery. The continuous measuring, automatic measuring and calibration can not be operated on neonate or pediatric patient. Please use the proper type of cuff as recommended in this manual, or the wrong type may lead to injury on patient, especially when measuring neonate.
  • Page 73 M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) Size of reusable cuff for neonate/pediatric/adult: Patient Type Limb perimeter Cuff width Hose Infant 10 cm ~19 cm 8 cm Child 18 cm ~ 26 cm 10.6 cm Adult 25 cm ~ 35 cm 14 cm 1.5 m or 3 m...
  • Page 74 M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) WARNING Prolonged non-invasive blood pressure measurements in automatic mode may be associated with purpuric, ischemic and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth and sensitivity.

  • Page 75: Nibp Setup Menu

    M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) NOTE: If you are in doubt about the accuracy of any reading(s), check the patient's vital signs by an alternative method before checking the functioning of the monitor. Initial Inflation Pressure...

  • Page 76: Nibp Unit Setup

    M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) Figure 9-2 NIBP SETUP INTERVAL: Set it to MANUAL, or 1/2/3/4/5/10/15/30/60/90/120/240/480 min. STAT Once this itme is selected, the menu will automatically exit from the screen and the monitor will perform continuous measurement immediately.

  • Page 77: Nibp Alarm Setup

    M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) PRES UNIT You may set the pressure unit to mmHg or KPa. The selected unit will present itself on the main interface. 9.4.3 NIBP Alarm Setup Enter SYSTEM MENU >ALARM SETUP: Figure 9-4 Alarm Setup Set the SYS, DIA, MAP alarm to turn on or off the alarm.
  • Page 78 M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) Default NIBP alarm limits: ADU (mmHg) PED (mmHg) NEO (mmHg) Lower Upper Lower Upper Lower Upper Limit Limit Limit Limit Limit Limit The adjusting range of NIBP alarm limits: Adult Mode...

  • Page 79: Nibp Alarm Message And Prompt Message

    M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) 9.5 NIBP Alarm Message and Prompt Message Tables below describe the possible physiological alarms, technical alarms and prompt messages occurring during NIBP measurement. Physiological alarms: Message Cause Alarm Level NIBP SYS measuring value is above upper...
  • Page 80 M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) MOTION noise is too large or pulse under monitoring rate is not regular. motionless. Measure again, if failure persists, stop using OVER Pressure has exceeded the measuring function of NIBP PRESSURE specified upper safety limit.

  • Page 81: Maintenance And Cleaning

    M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) 9.6 Maintenance and Cleaning WARNING Do not squeeze the rubber tube on the cuff. Do not allow liquid to enter the connector socket at the front of the monitor. Do not wipe the inner part of the connector socket when cleaning the monitor.
  • Page 82 M3 Vital Signs Monitor User Manual NIBP Monitoring (Optional) it into the opening on the long side of the cuff. Hold the tubes and the cuff and shake the complete cuff until the bag is in position. Thread the rubber tubes from inside the cuff, and out through the small hole under the internal flap.

  • Page 83: Chapter 10 Temp Monitoring (Optional)

    10.1 TEMP Monitoring with T2 Module 10.1.1 Introduction M3 with the T2 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 84: Measuring Procedure

    WARNING 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 85: Temp Setup Menu

    M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) If the predict measuring is successfully finished, the monitor enters MONITOR mode after 30s; otherwise the monitor enter MONITOR mode immediately after the predict measuring. The monitoring state lasts for 10 min, and then the monitor enters waiting state.
  • Page 86 M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) Figure10-3 System Setup TEMP UNIT: You may set the TEMP unit to ℃ or ℉. The selected unit will present itself on the main interface. 10.1.3.3 TEMP Alarm Setup Click on ALARM SETUP in the SYSTEM MENU, and set the alarm higher limit or lower limit...
  • Page 87 M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) Figure 10-4 Alarm Setup Menu ALM: pick ON to enable prompt message during the TEMP alarm; pick OFF to disable the alarm function, and display the symbol besides TEMP numeric. WARNING In order to avoid endangering the patient’s life, the user should use this function...

  • Page 88: Temp Alarm Message

    M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) The alarm limits are as follows: Patient Type Measure position ALM HI ALM LO Step +42 ℃ (+107.6 ℉) +35.5 ℃ (+95.9 ℉) +0.1 ℃ Oral/Axillary/Rectal +42 ℃ (+107.6 ℉) +35.5 ℃ (+95.9 ℉) +0.1 ℃...
  • Page 89 M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) Probe data error Offline: Put the sensor into the sensor resistance >R 0 ℃; bracket, take measure again. If the problem Short:NTC resistance persists, stop using measuring ℃ <R+100 function of TEMP module, notify biomedical engineer or Manufacturer’s service staff.

  • Page 90: Care And Cleaning

    M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) 10.1.5 Care and Cleaning WARNING Before cleaning the monitor or the probe, make sure that the equipment is switched off and disconnected from the power line. Reusable TEMP Probes The TEMP probe should not be heated above +100 ℃ (+212 ℉). It should only be briefly exposed to temperatures between +80 ℃...

  • Page 91: Temp Monitoring With Th Module

    M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) 10.2 TEMP Monitoring with TH Module 10.2.1 Introduction M3 with the TH module (Intrared Ear Temperature Module) takes a temperature in the ear. Diagram of the Intrared Ear Thermometer Batter Cover Pin Hole WARNING Keep the probe covers away from children.

  • Page 92: Measuring Procedure

    M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) CAUTION Check whether the thermometer is damaged once it drops. If you cannot make sure of it, send the complete device to your local dealer for recalibration. Keep the unit dry and away from any liquids and direct sunlight.
  • Page 93 M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) For children over two-year old and adults: pull the ear straight up and back as shown below: Press the “Scan” button for one second until you hear a long beep sound which signals the end of the measurement, and rusults will be shown on the display of the monitor.

  • Page 94: Alarm

    M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) 10.2.3 Alarm The alarm limits are as follows: Patient Type Measure ALM HI ALM LO Step position +42 ℃ (+107.6 ℉ +35.5 ℃ (+95.9 ℉ +0.1 ℃ ADU/PED/NEO Physiological alarms: Message...

  • Page 95: Maintenance And Cleaning

    M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) Hold the thermometer and flip the battery out with a small screwdriver. Insert the new battery under the metal hook on the left side and press the right side of the battery down until the it clicks in place.
  • Page 96 M3 Vital Signs Monitor User Manual TEMP Monitoring (Optional) Please send the complete device to the dealers or nearest service address. However, if this device is used according to the operation instructions, periodic re-calibration is not required. Cleaning The probe is the most delicate part of the thermometer. Use it with care when cleaning the lens to avoid damage.

  • Page 97: Chapter 11 Other Functions

    M3 Vital Signs Monitor User Manual Other Functions Chapter 11 Other Functions 11.1 Nurse Call The monitor provides dedicated nurse call port which is connected to nurse call system through the nurse call cable to perform the nurse call function.

  • Page 98: Chapter 12 Accessories And Ordering Information

    M3 Vital Signs Monitor User Manual Accessories and Ordering Information Chapter 12 Accessories and Ordering Information WARNING The specification of accessories recommended is listed below. Using other accessories may damage the monitor. The following accessories are recommended when using this monitor.
  • Page 99 M3 Vital Signs Monitor User Manual Accessories and Ordering Information NELLCOR SPO Nellcor Reusable Adult SpO Sensor (DS-100A OxiMax) (Weak Perfusion 11.15.30043 Resistance) 11.15.40096 Nellcor Reusable Adult/Neonate SpO Sensor (OXI-A/N OxiMax) Nellcor SpO Extension cable (Compatible with Nellcor OXI-Max SpO 11.13.30131-11...
  • Page 100 M3 Vital Signs Monitor User Manual Accessories and Ordering Information OTHERS 01.57.78035 Printing paper 12.01.109480 Trolley 02.01.109481 Wall hanger 02.01.109592 Pole Clamp /1 piece 02.01.109636 Pole Clamp /4 pieces 01.13.36014 Power cable (EUR standard) 220V 11.13.36015 Power cable (USA standard) 21.21.064167...

  • Page 101: Chapter 13 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 102: Appendix Specifications

    M3 Vital Signs Monitor User Manual Specifications Appendix Specification s A1.1 Classification Anti-electroshock type Class equipment and internal powered equipment EMC type Class A Anti-electroshock degree , NIBP: BF Defibrillation type; TEMP: CF type (T2 module) BF type (TH module)

  • Page 103: A1.2.3 Display

    M3 Vital Signs Monitor User Manual Specifications Temperature +5 °C ~ +40 °C Working With TEMP: +10 °C ~ +40 °C -20 °C ~ +55 °C Transport and storage With TH module: -20 °C ~ +50 °C Humidity Working 25% ~ 80% (non-condensing)

  • Page 104: A1.2.4 Battery

    M3 Vital Signs Monitor User Manual Specifications 3 indicating modes correspond to Alarm Mode NURSE CALL Drive mode Relay ≤ 1A, ≤125V ~, ≤110V DC Electronic Isolated voltage 1500V ~ Action Normal open A1.2.4 Battery Quantity Type Li battery Power-off delay...

  • Page 105: A1.2.6 Review

    M3 Vital Signs Monitor User Manual Specifications A1.2.6 Review Trend list recall 72 hours, 1 min Resolution NIBP measurement recall 30, 000 NIBP measurement data Alarm list recall 800 groups A1.2.7 NIBP (Optional) Method Oscillometric Mode Manual, Auto, Continuous Measuring interval in AUTO mode...

  • Page 106: A1.2.8 Spo (Optional)

    M3 Vital Signs Monitor User Manual Specifications Maximum standard deviation 8 mmHg Maximum measuring time of single ADU/PED 120s measurement Typical measuring period 30s ~ 45s (depend on HR/motion disturbance) Overpressure protection Dual overpressure protection (297±3) mmHg (240±3) mmHg (147±3) mmHg...
  • Page 107 M3 Vital Signs Monitor User Manual Specifications Red light 660±3 nm Infrared light 905±5 nm Emitted light energy Less than 15 mW Nellcor module (optional) Measuring Range 1% ~ 100% Alarm Range 1% ~ 100% Resolution Data update period Sensor Type...

  • Page 108: A1.2.9 Temp (Optional)

    M3 Vital Signs Monitor User Manual Specifications A1.2.9 TEMP (Optional) T2 Module: Measuring range 25°C ~ 45°C Working temperature 10°C ~ 40°C Sensor type Oral /axillary /rectal Alarm range 35.5°C ~ 42°C Resolution 0.1°C ±0.1°C (25°C ~ 45°C) Accuracy Response time <...
  • Page 109 M3 Vital Signs Monitor User Manual Specifications Working frequency segment Ch1 ~ 11 (America) Ch1 ~ 14 (Japan) Ch1 ~ 13 (ETSI) - 103 -...

  • Page 110: Appendix Emc Information - Guidance And Manufacture's Declaration

    SYSTEMS Guidance and manufacture’s declaration-electromagnetic emission The M3 is intended for use in the electromagnetic environment specified below, The customer or the user of the M3 should assure that it is used in such and environment. Emission test Compliance Electromagnetic environment-guidance The M3 uses RF energy only for its internal function.
  • Page 111 M3 Vital Signs Monitor User Manual EMC Information ±2 kV contact ±2 kV contact 30%. ±4kV air. ±4kV air. Electrical fast ±2kV for power ±2 kV for power Mains power quality should transient/burst supply lines; supply lines; that typical commercial...

  • Page 112: A2.3 Electromagnetic Immunity - For Equipment And Systems That Are Not Life-Supporting

    Guidance and manufacturer’s declaration – electromagnetic immunity The M3 is intended for use in the electromagnetic environment specified below. The customer or the user of M3 should assure that it is used in such an environment. Immunity IEC/EN 60601 test...

  • Page 113: A2.4 Recommended Separation Distances

    Recommended separation distances between portable and mobile RF communications equipment and the M3 Vital Signs Monitor The M3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the M3 can help prevent...

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