About this Manual P/N: 01.54.112593-13 Release Date: April 2012 © Copyright EDAN INSTRUMENTS, INC. 2010-2012. 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.
Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
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........................................................................
4.10 Standby Mode ....................................................................................................................33 Chapter 5 Alarm...............................................................................................................................35 5.1 Alarm Modes........................................................................................................................35 5.1.1 Alarm Level...........................................................................
10.3 NIBP Setup Menu ..............................................................................................................61 10.3.1 NIBP Setup..............................................................................................................61 10.3.2 NIBP Alarm Setup...................................................................................................61 10.4 NIBP Alarm Message and Prompt Message ......................................................................63 10.
A2.3 Electromagnetic Immunity - For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING.........................................................................................................93 A2.4 Recommended Separation Distances ................................................................................
M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use The M3A Vital Signs Monitor (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of arterial blood), NIBP (non-invasive blood pressure) and TEMP (temperature). The monitor is intended to be used only under regular supervision of clinical personnel.
M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance 1.2.4 Equipotential Grounding Protection class 1 instruments are already included in the protective grounding (protective earth) system of the room by way of grounding contacts in the power plug. For internal examinations on the heart or the brain, the Monitor must have a separate connection to the equipotential grounding system.
M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING 6 SHOCK HAZARD- the power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug of the monitor to fit a two-slot outlet. 7 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN60950 for data processing equipment and IEC/EN60601-1 for medical equipment).
M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING 21 The simultaneous use of cardiac pacemaker and other patient-connected equipment may cause safety hazard. 22 Please disinfect timely to prevent cross infection between patients. 23 This monitor is not a device for treatment purposes. 24 Only NIBP and SpO2 applied parts of the monitor are defibrillation-proof. When a defibrillator is applied, keep other accessories away from the patient.
M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance CAUTION 9 Before use, the equipment, patient cable and sensor should be checked. Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or performance. 10 The disposable accessories can not be reused. 11 Avoid liquid splash and excessive temperature. The temperature must be kept between +5℃ and +40℃ while working.
M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance This symbol indicates that the instrument is IEC/EN60601-1 Type BF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock. It is not suitable for use during defibrillation. This symbol indicates that the instrument is IEC/EN60601-1 Type CF equipment.
M3A Vital Signs Monitor User Manual P/N Intended Use and Safety Guidance Part Number Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Rx only Federal law (U.S.) restricts this device to sale by or on the order of a physician.
M3A Vital Signs Monitor User Manual Installation of Monitor Chapter 2 Installation of Monitor NOTE: To ensure that the monitor works properly, please read Chapter 1 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. If any signs of mishandling or damage are detected, contact the carrier to claim for damage. Open the package and take out the monitor and accessories carefully.
M3A Vital Signs Monitor User Manual Installation of Monitor NOTE: 1 During POST, make sure all the seven segments are bright, which indicates the seven segments function well. 2 Check all the functions of the monitor and make sure that the monitor is in good condition. 3 If rechargeable batteries are provided, recharge them after using the monitor every time to ensure the electric power is enough. 4 The interval between double presses of the ON/OFF button should be more than 1 second.
M3A Vital Signs Monitor User Manual Introduction Chapter 3 Introduction 3.1 General Information The monitor integrates the function of parameter measurement modules, display and output to compose a compact, portable device. Its built-in replaceable battery provides convenience for patient movement. The monitor is a user-friendly device with operations conducted by a few buttons on the front panel. Refer to section 3.3 Button Functions for more details.
M3A Vital Signs Monitor User Manual Introduction M3A Vital Signs Monitor can monitor: SpO2: Oxygen saturation of arterial blood (SpO2); Pulse Rate (PR); SpO2 PLETH (Plethysmogram); NIBP: Systolic Pressure (SYS); Diastolic Pressure (DIA); Mean Pressure (MAP); Pulse Rate (PR). TEMP: Temperature. The monitor provides extensive functions such as visual and audible alarms, storage for data, SpO2/NIBP/TEMP measurements review, nurse call and so on. 3.2 Screen Display The monitor is equipped with LCD.
M3A Vital Signs Monitor User Manual Introduction ① ④ ③ ② ③ Figure 3-2 Main display The NIBP multi-group Review and SpO2 waveform area is displayed as follows: Figure 3-3 NIBP Multi-group Review Change the display on the screen to Trend list as follows: - 12 -
M3A Vital Signs Monitor User Manual Introduction Figure 3-4 Display trend list Change the display on the screen to Trend graph as follows: Figure 3-5 Display SpO2 trend graph The icons on the interface and their meanings are as follows: Battery status indicator Connected to mains power supply Audio system off Audio alarm pause Parameter alarm off - 13 -
M3A Vital Signs Monitor User Manual Introduction Indicates an error occurs Note Warning Password protection Patient type: ADU (adult) Patient type: PED (pediatric) Patient type: NEO (neonatal) Measuring TEMP oral Measuring axillary TEMP Measuring TEMP rectal Measuring TEMP ID 23：31：08 For device with the T2 TEMP module only. ear For device with the Intrared Ear Temperature module only.
M3A Vital Signs Monitor User Manual Introduction NIBP: ⎯ SYS, DIA, MAP (Unit: mmHg or kPa). ⎯ Pulse Rate (Pulse Rate, Unit: BPM) TEMP: ⎯ Temperature (Unit: ℃ or ℉). The PR signal from SpO2 measuring takes priority to be displayed. Waveform/Trend List ( ②) It can display SpO2 waveform, NIBP multi-group review, trend list or trend graph. Information Area ( ③ ④) The Information Area is at the right and bottom parts of the screen, displaying operating status of the monitor and condition of the patient.
M3A Vital Signs Monitor User Manual Introduction 3.2.
M3A 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.
M3A Vital Signs Monitor User Manual Introduction 3.3 Button Functions ④ ⑤ ⑥ ⑦ ⑧ ⑨ ① ② ③ Figure 3-8 Buttons All the operations to the monitor can be finished by several buttons. ON/OFF When the monitor is off, press this button to turn it on. When the monitor is on, press this button and hold for 2s to turn off the monitor; or press this button for less than 1s, the menu for entering Standby Mode is displayed. NIBP START/STOP To inflate the cuff and start blood measuring.
M3A Vital Signs Monitor User Manual TREND/WAVEFORM ③ Introduction Press this button to switch among waveform display, trend list and trend graph display. Press this button for less than 2s to silence the audible displays in the alarm for a period; the icon information area and the indicator beside the button flashes. When pressing it again or the pause time is over, the audible alarm will resume to the normal monitoring status, and the indicator is off.
M3A Vital Signs Monitor User Manual Introduction The LED beside this icon indicates the power condition. When the monitor connects to the mains power supply, the LED is bright. ⑨ POWER Indicator 3.4 Interfaces For the convenience of operator, interfaces of different functions are in different sites of the monitor. Sensor port on the front panel ① ② Figure 3-9 Sensor Connectors Connectors for cables and sensors are as shown in Figure 3-9. 1. SpO2 sensor connector ① 2.
M3A Vital Signs Monitor User Manual Introduction Rear Panel ① ③ ② Figure 3-10 Rear Panel Sockets on the rear panel are shown in the above figure: ① Equipotential grounding terminal for connecting to the hospital’s grounding system. ② Power supply socket: 100V–240V ~, 50Hz/60Hz. ③ The port can be used as the Nurse Call connector and serial port (or as the interface to the Ethernet).
M3A Vital Signs Monitor User Manual Introduction Bottom panel There are battery compartment and fuse box on the bottom panel. Battery compartment cover Fuse box Figure 3-11 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 or in the bottom right corner of screen.
M3A Vital Signs Monitor User Manual Introduction Replace Battery In monitoring or communication state, the battery status indicator will flash when the battery is low or empty. When the lifespan of battery is over, foul odor or leakage is detected, please contact the manufacturer or local distributor for replacement of battery. WARNING 1 Do not take off the battery when monitoring. The unexpected power supply off can not impact on the normal monitor working, if it has battery for standby.
M3A 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 the MENU button on the front panel to open Main Menu. You can perform the following operations in this menu. Figure 4-1 System Memu 4.1 Patient Setup Click on Patient Setup in Main Menu to open the following menu.
M3A Vital Signs Monitor User Manual System Menu 4.3 SpO2 Setup Please refer to 9.5.1 SpO2 Setup for more information. 4.4 TEMP Setup Please refer to 11.1.3.1 or 11.2.3 TEMP Setup for more information. 4.5 Alarm Setup Select Alarm Setup in Main Menu to open submenu as shown below, in which the user may turn on or off alarm or set the upper alarm limit or lower alarm limit. Set the item to ON, the alarm system is turned on.
M3A Vital Signs Monitor User Manual System Menu Start Data Transmission: select this item to start transmitting data from monitor to data management software. 4.7 Recorder Select Recorder in Main Menu to open the following menu. Figure 4-5 Recorder Record Realtime Data: Select it to output the real time data from the monitor. Record Trend Graph: Select it to output the trend graph. Record Trend Table: Select it to output the trend table. Please refer to Chapter 7 Recording for more information.
M3A Vital Signs Monitor User Manual System Menu Figure 4-7 General Setup Key Volume: set key volume to level 0 ~ 5. LCD Brightness: set LCD brightness to level 1 ~ 5. Standby Mode: set to ON or OFF. If you set this item to ON, when pressing ON/OFF button for less than 1s, the monitor will enter Standby Mode. (Please refer to 4.10 Standby Mode for more information.) Work Mode: set to Spot or Monitor. 4.8.
M3A Vital Signs Monitor User Manual System Menu Figure 4-9 Time Setup 4.8.4 Default Configuration NOTE: Select any item in this submenu to cancel the current setup and use the selected default setup.
M3A Vital Signs Monitor User Manual System Menu User Maintenance Input the user password 9 9 8 1 in the Enter Password box and press Confirm: Figure 4-12 Enter the Password User Maintenance menu will pop up, in which you can set the following items. Figure 4-13 User Maintenance Language: Set the displaying language. NOTE: The user should restart the monitor after changing the displaying language. Nurse Call: Turn on or off the nurse call.
M3A Vital Signs Monitor User Manual System Menu 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. Then the monitor will inflate the cuff according to the previous memorized measurements. This function accelerates the measuring of the patient’s blood pressure. NIBP Reset: select it to reset the NIBP module. - Restore measurement status.
M3A Vital Signs Monitor User Manual System Menu Leak Test This item is used for air leakage test. Press this item to start the air leakage test. Then the item will change into Stop Leakage Test. If it is picked again, the system will stop air leakage test. WARNING This leakage test other than being specified in the IEC/EN1060-1 standard is to be used by the user to simply determine whether there are air leaks in the NIBP airway.
M3A Vital Signs Monitor User Manual Sensitivity System Menu Figure 4-17 SpO2 Setup The SpO2 reading is the average of data collected within a specific time. You can set Sensitivity to Low, Medium or High via the menu. The higher the sensitivity is, the quicker the pulse oximeter responds to the changes in the patient’s oxygen saturation level.
M3A Vital Signs Monitor User Manual System Menu Net Setup Access Net Setup and you can see the menu below: Figure 4-19 Net Setup Bed No.: Set the bedside monitor number to a value from 1~64. 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 the server port. Exit: Exit the menu.
M3A Vital Signs Monitor User Manual System Menu Figure 4-21 2. If the battery is low, press the ON/OFF button for less than 2 seconds, the following dialog box displays: Figure 4-22 Quitting Standby Mode In Standby Mode, press any button on the front panel to quit standby mode.
M3A 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. an intensive care unit or cardiac operating room. 5.1 Alarm Modes 5.1.
M3A 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 alarm prompt will display on the screen of the monitor. The description will display in Information area, such as “**SYS TOO HIGH” to indicate the low-medium level alarm. Technical alarm will not prompt * signal.
M3A Vital Signs Monitor User Manual Alarm 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. NOTE: 1 The monitor does not have alarm condition delay or alarm signal generation delay.
M3A Vital Signs Monitor User Manual Alarm 5.2 Alarm Cause Alarm occurs when: 1. Physiological alarm is evoked; 2. Alarm for error of the system (technical alarm) is evoked; 3. General alert occurs. A. Conditions that activate the parameter alarms: The measurement value exceeds the alarm limit and the alarm is set to ON. Alarms will not be activated if the alarm is set to OFF. B.
M3A Vital Signs Monitor User Manual Alarm 5.4 Parameter Alarm WARNING 1 2 Prior to monitoring, make sure that the alarm limit settings are appropriate for your patient. Setting alarm limits to extreme values may cause the alarm system to become ineffective. In Main Menu > Alarm Setup, you can check and set the alarm limit or alarm status. The setup is isolated from each other. When a parameter alarm is OFF, an icon displays near the parameter.
M3A Vital Signs Monitor User Manual Trend Chapter 6 Trend The monitor provides 100-hour trend data of all parameters (SYS, MAP, DIA, PR, SpO2, TEMP), 2-hour trend graph of NIBP/SpO2/PR/TEMP, storage data of 12, 000 NIBP measurement results and 200 Patient IDs. 6.
M3A Vital Signs Monitor User Manual Trend Select one data file and press the OK button, the following menu and deleting process are displayed: Figure 6-3 Delete Data in Trend List When deleting data, the process bar is diaplayed: Figure 6-4 Deleting process 6.
M3A Vital Signs Monitor User Manual Trend Figure 6-6 NIBP Trend Graph You can set the items below the trend graph. Item: you can set the display parameter to NIBP, SpO2 or PR. Y: it stands for the ordinate which indicates the displayed data range. X: it stands for the abscissa which indicates the displayed time range.
M3A Vital Signs Monitor User Manual Recording Chapter 7 Recording 7.1 Recorder A thermal dot matrix recorder is used for the monitor. It supports the printout of real time data, trend graph and trend table. 7.1.1 Performance of the Recorder Waveform record is printed at the rate of 25 mm/s 48mm wide printout papaer A real time waveform onscreen can be printed out 7.1.2 Operations Requirement for the Recording Paper Use only specified thermal paper.
M3A Vital Signs Monitor User Manual 1. 2. 3. Recording Cut the paper from the feeding edge. Open the recorder door. Reload the paper and close the recorder door. 7.2 Outputing the Monitoring Data By selecting the items on Main Menu > Recorder (Figure 7-1), you can output the real time data, trend graph and trend table. Figure 7-1 Record Realtime Data: Select this item, and the recorder will output the real time data including measurements and SpO2 waveforms.
M3A Vital Signs Monitor User Manual Maintenance and Cleaning Chapter 8 Maintenance and Cleaning 8.1 System Check Before using the monitor, do the following: ■ Check if there is any mechanical damage; ■ Check if all the outer cables, inserted modules and accessories are in good condition; ■ Check all the functions of the monitor to make sure that the monitor is in good condition.
M3A Vital Signs Monitor User Manual Maintenance and Cleaning CAUTION Please pay special attention to the following items: 1 Most cleaning agents must be diluted before use. Follow the manufacturer's directions carefully to avoid damaging the monitor. 2 Do not use the grinding material, such as steel, wool etc. 3 Do not let the cleaning agent enter into the chassis of the system. 4 Do not leave the cleaning agents at any part of the equipment. The monitor, cables and accessories must be kept dust-free.
M3A Vital Signs Monitor User Manual Maintenance and Cleaning 8.3 Sterilization To avoid extended damage to the equipment, sterilization is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Sterilization facilities should be cleaned first. Recommended sterilization material: Ethylate, and Acetaldehyde. Appropriate sterilization materials for blood pressure cuff are introduced in relative chapters respectively.
M3A Vital Signs Monitor User Manual Maintenance and Cleaning 8.5 Replacement of Fuse Unscrew the fuse cap anticlockwise, replace the fuse (protector tube) and screw down the fuse cap clockwise. Fuse size: Ф5×20, Rated value: T 1.6 AL /250 V. NOTE: Switch off the power of the monitor before examining the fuse. 8.6 Cleaning Battery and Battery Compartment Cover Use only non-caustic detergents such as soap and warm water (+40℃/+104℉ maximum) to clean the battery.
M3A Vital Signs Monitor User Manual SpO2 Monitoring (Optional) Chapter 9 SpO2 Monitoring (Optional) 9.1 What is SpO2 Monitoring The monitor uses oximetry to measure functional oxygen saturation in the blood. SpO2 Plethysmogram measurement is employed to determine the functional oxygen saturation of hemoglobin in the arterial blood. For example, if 97% hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has an SpO2 oxygen saturation of 97%.
M3A Vital Signs Monitor User Manual SpO2 Monitoring (Optional) 9.2 Precautions During SpO2/PR Monitoring WARNING 1 Verify sensor cable fault detection before beginning of monitoring phase. Unplug the SpO2 sensor cable from the socket, the screen will display the error message SpO2 SENSOR OFF and the audible alarm is activated. 2 If the SpO2 sensor can not work properly, please reconnect the sensor or change a new one.
M3A Vital Signs Monitor User Manual SpO2 Monitoring (Optional) 9.3 Monitoring Procedure SpO2 plethysmogram measurement 1. Connect the SpO2 sensor and extension cable to the SpO2 sensor port of monitor. 2. Switch on the monitor. 3. Enter Patient Setup menu to set Patient Type as required. 4. Attach the sensor to the appropriate site of the patient finger. 5. The measured SpO2 is displayed on screen. Figure 9-1 Mounting of the Sensor 9.
M3A Vital Signs Monitor User Manual SpO2 Monitoring (Optional) 9.5 SpO2 Setup Menu 9.5.1 SpO2 Setup Click on SpO2 Setup in Main Menu to open the following menu: Figure 9-2 SpO2 Setup Pulse Volume: Set it to level 0 ~ 5. Pitch Tone: set it to ON or OFF. PI: If it is set to ON, the perfusion index will be presented on the main interface. If it is set to OFF, the perfusion index is unavailable onscreen. 9.5.
M3A Vital Signs Monitor User Manual SpO2 Monitoring (Optional) WARNING In order to avoid endangering the patient’s life, the user should use this function cautiously. The range of SpO2 alarm limit is: 0 ~ 100. Default SpO2 alarm limits: Max. Upper Limit Min. Lower Limit Step ADU 100 90 1 PED 100 90 1 NEO 95 90 1 Max. Upper Limit Min. Lower Limit Step ADU 120 50 1 PED 160 75 1 NEO 200 100 1 The range of PR alarm limit is: 30 ~300. Default PR alarm limits: 9.
M3A Vital Signs Monitor User Manual SpO2 Monitoring (Optional) Message Cause Alarm Level SpO2 NO PULSE Sphygmic signal from the measured position is too weak; the monitor does not detect any sphygmic signal. High Technical alarms: Message Cause SpO2 MODULE ERR What to do High Stop using measuring function of SpO2 module, notify biomedical engineer or manufacturer’s service staff. The sensor or connector has shortcut. High Change the sensor.
M3A Vital Signs Monitor User Manual SpO2 Monitoring (Optional) Prompt message: Message Cause Searching pulse SpO2 sensor may be disconnected from the patient or the monitor. SpO2 ALARM OFF The alarm of SpO2 is turned off. 9.7 Maintenance and Cleaning WARNING 1 Before cleaning the monitor or the sensor, make sure that the equipment is switched off and disconnected from the power line. 2 Do not subject the sensor to autoclaving. 3 Do not immerse the sensor into any liquid.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) Chapter 10 NIBP Monitoring (Optional) 10.1 Introduction 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. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) 4 It is suggested that the user should not start NIBP measuring when the low battery displays, or the monitor may be turned off automatically. 10.2 NIBP Monitoring WARNING 1 Before starting a measurement, verify that you have selected a setting appropriate for your patient (adult, pediatric or neonatal.) 2 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) NOTE: The width of the cuff should be either 40 % of the limb circumference (50% for neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 50% ~ 80% of the limb. The wrong size of cuff can cause erroneous readings. If the cuff size is in question, then use a larger cuff.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) WARNING Prolonged NIBP 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. If any abnormality is observed, stop the blood pressure measurements.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) WARNING If liquid is inadvertently splashed on the equipment or its accessories, or it may enter the conduit or inside the monitor, contact local Customer Service Center. 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.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) 10.3 NIBP Setup Menu 10.3.1 NIBP Setup In Main Menu, open the NIBP Setup menu shown as below: Figure 10-2 NIBP SETUP Interval: Set it to Manual, or 1/2/3/4/5/10/15/30/60/90/120/240/480 min. Unit: Set the pressure unit to mmHg or KPa. The setting unit will display on the main interface. Continual: select it to do NIBP measuring continuously within 5min. 10.3.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) WARNING In order to avoid endangering the patient’s life, the user should use this function cautiously. Set High for the higher alarm limit, and set Low for the lower alarm limit. If the measured value is higher than High or lower than Low, the monitor will give an alarm. The adjusting range of NIBP alarm limits is: 0 mmHg ~ 300 mmHg.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) Default PR alarm limit: Max. Upper Limit (BPM) Min. Lower Limit (BPM) Step (BPM) ADU 120 50 1 PED 160 75 1 NEO 200 100 1 Max. Upper Limit (BPM) Min. Lower Limit (BPM) Step (BPM) 300 0 1 The range of PR alarm limit: PR 10.4 NIBP Alarm Message and Prompt Message Tables below describe the possible physiological alarms, technical alarms and prompt messages occurring during NIBP measurement.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) Technical alarms: (display in the area below the NIBP value): Message Cause Alarm Level What to do NIBP COMM STOP NIBP module failure or communication failure. High Stop using measuring function of NIBP module, notify biomedical engineer or manufacturer’s service staff. NIBP ILLEGAL RESET The hardware pressure is too high High NIBP MODULE ERR The NIBP module has failure.
M3A Vital Signs Monitor User Manual Message MEASURE TIMEOUT NIBP Monitoring (Optional) Cause Alarm Level What to do Measuring time has exceeded 120s (adult) or 90s (neonatal). Low Measure again or use other measuring methods. INIT PRESSURE TOO HIGH The initial pressure is too high during measuring Low Measure again, if failure persists, stop using measuring function of NIBP module and notify biomedical engineer or manufacturer’s service staff.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) 10.5 Maintenance and Cleaning WARNING 1 Do not squeeze the rubber tube on the cuff. 2 Do not allow liquid to enter the connector socket at the front of the monitor. 3 Do not wipe the inner part of the connector socket when cleaning the monitor. 4 When the reusable cuff is not connected with the monitor, or being cleaned, always place the cover on the rubber tube to avoid liquid permeation.
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) To replace the rubber bag in the cuff, first place the bag on top of the cuff so that the rubber tubes line up with the large opening on the long side of the cuff. Now roll the bag lengthwise and insert 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.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) Chapter 11 TEMP Monitoring (Optional) 11.1 TEMP Monitoring with T2 Module 11.1.1 Introduction M3A 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.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) WARNING 7 Biting the sensor tip while taking a temperature may result in damage to the sensor. 8 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. TEMP measurement isn’t suitable for use during defibrillation. 9 11.1.2 Measuring Procedure 1 Ensure the sensor are well installed.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) monitoring state lasts for 10 min, then the monitor enters waiting state. — — — displays in the TEMP parameter area on interface. Put the sensor back into the sensor bracket. 7 If necessary, repeat the measurement according to the procedure above. NOTE: 1 After one measurement, the user should put the sensor back to the sensor bracket and then take it out for starting a new measurement.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) Figure 11-3 Alarm Setup Menu TEMP: set it to ON to enable prompt message during the TEMP alarm, while set to 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 cautiously. Set High for the higher alarm limit, and set Low for the lower alarm limit.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) Technical alarms: Message Cause TEMP COMM STOP TEMP module failure or communication failure. TEMP EXCCED LIMIT The TEMP value is beyond the range of +25℃ ~ +45℃. TEMP NO SENSOR TEMP sensor is not connected to the TEMP module. AMBIENT TEMP HIGH The Sensor temperature is higher than +40℃ AMBIENT TEMP LOW The Sensor temperature is lower than +10℃ TEMP SENSOR ERR Offline: NTC resistance >R 0 ℃; Short:NTC
M3A Vital Signs Monitor User Manual Message TEMP MODULE ERR TEMP Monitoring (Optional) Cause Alarm Level What to do High Put the sensor into the sensor bracket, take it out and measure again. If the problem persists, stop using measuring function of TEMP module, notify biomedical engineer or Manufacturer’s service staff. TEMP module self check failure Prompt: Message Cause What to do Ready to TEMP predict The monitor prompts it after taking the sensor out of the bracket and warm-up is over.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) 4 Any residue should be removed from the probe before being disinfected and sterilized, and avoid contacting corrosive solvent. Dipping the cable into alcohol or alkalescent solvent for a long time may reduce the flexibility of the scarfskin of the cable. Also, the connector should not be dipped. 5 After monitoring, disinfect the probe according to the instruction described in the user manual.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) 11.2 TEMP Monitoring with TH Module 11.2.1 Introduction M3A with the TH module (Intrared Ear Temperature Module) takes a temperature in the ear. Diagram of the Intrared Ear Thermometer Batter Cover Pin Hole 1 2 3 4 1 2 3 4 WARNING Keep the probe covers away from children. Do not resue the disposable probe covers. Only use the disposable probe covers supplied or recommended by EDAN.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) CAUTION 5 Holding the thermometer too long may cause a higher ambient temperature reading of the probe, which could make the body temperature measurements lower than usual. 6 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. 7 Keep the unit dry and away from any liquids and direct sunlight. 8 The probe should not be submerged into liquids.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) NOTE: For children over two-year old and adults: pull the ear straight up and back as shown below: 5. 6. 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. Before starting another measurement, wait until all icons stop flashing and two beep sounds are heard.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) 11.2.3 TEMP Setup Menu Click on the TEMP Setup in the Main Menu to display the following figure: Figure11-2 TEMP Setup TEMP Unit: Set temperature unit to ℃ or ℉. For information about alarm setup, refer to section 11.1.3.2 TEMP Alarm Setup. 11.2.4 Alarm Message The alarm limits are as follows: Patient Type ADU/PED Measure position Ear ALM HI ALM LO Step +42 ℃ (+107.6 ℉) +35.5 ℃ (+95.9 ℉) +0.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) The infrared ear thermometer will also give error messages on its screen. For details about the error messages, refer to the accompanying operating instructions of the thermometer. NOTE: If the infrared ear thermometer frequently signals ERR alarms, the insulated board inside the thermometer housing is malfunctioning or the ambient temperature changes, the monitor will delete the measurement values onscreen to avoid misoperation. 11.2.
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) 11.2.6 Maintenance and Cleaning Calibration Mode To switch to calibration mode, follow the steps below: a Press the ON/MEM button to turn the thermometer on. The display of the thermometer shows symbols and functions. b Keep pressing the ON/MEM button for five seconds and you will see the “OFF” symbol on the display. Do not release the button until you see a dot onscreen.
M3A 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. Standard configuration including: Part Number Accessories 02.01.210119 EDAN SH1 adult reusable SpO2 sensor (Only compatible with EDAN SpO2 module). 01.57.
M3A Vital Signs Monitor User Manual Accessories and Ordering Information 12.01.110515 EDAN SH4 adult silicone soft-tip SpO2 sensor (Only compatible with EDAN SpO2 module and extension cable). 02.01.110531 EDAN SH4 adult silicone soft-tip SpO2 sensor (Immersion disinfection). 02.01.210121 EDAN SH5 pediatric Silicone Soft-tip SpO2 Sensor ( DB9) (Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable), 1m 01.57.040196 Adult disposable SpO2 sensor/ SESI001B. 01.57.
M3A Vital Signs Monitor User Manual Accessories and Ordering Information 01.57.471158 Neonatal #2 Disposable Blood Pressure Cuff (4-8cm) (Only compatible with Connecting Tube for Neonatal Cuff) 01.57.471159 Neonatal #3 Disposable Blood Pressure Cuff (6-11cm) (Only compatible with Connecting Tube for Neonatal Cuff) 01.57.471160 Neonatal #4 Disposable Blood Pressure Cuff (7-13cm) (Only compatible with Connecting Tube for Neonatal Cuff) 01.57.
M3A Vital Signs Monitor User Manual Warranty and Service Chapter 13 Warranty and Service 13.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) damage caused by mishandling during shipping. b) subsequent damage caused by improper use or maintenance. c) damage caused by alteration or repair by anyone not authorized by EDAN.
M3A Vital Signs Monitor User Manual Specifications AppendixⅠSpecifications A1.
M3A Vital Signs Monitor User Manual Transport and Storage Specifications -20 °C ~ +55 °C With TH module: -20 °C ~ +50 °C Humidity Working 25% ~ 80% (non- condensing) Transport and Storage 25% ~ 93% (non- condensing) Altitude Working 860hPa ~ 1060hPa Transport and Storage 700hPa ~ 1060hPa Power Supply Voltage: 100V–240V ~ Frequency: 50Hz/60Hz Input power: 70VA Battery: 14.8 V/4.4 Ah; 14.8 V/2.2 Ah. A1.2.
M3A Vital Signs Monitor User Manual Specifications Electronic ≤1A, ≤125V ~, ≤110V DC Isolated voltage 1500V ~ (line to ground) Action Normal open A1.2.4 Battery Quantity 1 Type Li battery Power-off delay 5 min ~ 15 min (After the low battery alarm) Voltage 14.8 VDC Capacitance 2.2 Ah 4.4 Ah (optional) Working period 2.2 Ah: 8.5 hours 4.4 Ah: 17 hours (At +25℃, continuous SpO2 measuring, automatic NIBP measuring per 15min) Rechargeable period 2.2 Ah: 180 min 4.4 Ah: 360 min A1.2.
M3A Vital Signs Monitor User Manual Specifications A1.2.6 Review Trend List Review 100 hours, 30 seconds Resolution Measurement Review 12, 000 groups measuring data A1.2.
M3A Vital Signs Monitor User Manual Specifications ADU (297±3) mmHg PED (240±3) mmHg NEO (147±3) mmHg PR Measuring range 40 bpm ~ 240bpm Accuracy The maximum of ±3bpm or 3.5% A1.2.
M3A 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 Accuracy ±0.1°C (25°C ~ 45°C) Response time < 60s Update time 1s ~ 2s TH Module: Measuring range 34°C ~ 42.2°C Working temperature 10°C ~ 40°C Alarm range 35.5°C ~ 42°C Resolution 0.1°C Accuracy ±0.2°C (35.5°C ~ 42°C) ±0.
M3A Vital Signs Monitor User Manual EMC Information AppendixⅡ EMC Information Manufacture’s Declaration - Guidance and A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration-electromagnetic emission The M3A is intended for use in the electromagnetic environment specified below, the customer or the user of the M3A should assure that it is used in such an environment.
M3A Vital Signs Monitor User Manual Electrical fast transient/burst IEC 61000-4-4 EMC Information power ±2 kV for power Mains power quality should be that of a typical commercial or supply lines; hospital environment. With TH module: With TH module: ±2kV for supply lines; ±1 kV for power supply lines. ±1 kV for power supply lines.
M3A Vital Signs Monitor User Manual EMC Information A2.3 Electromagnetic Immunity - For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The M3A is intended for use in the electromagnetic environment specified below. The customer or the user of M3A should assure that it is used in such an environment.
M3A Vital Signs Monitor User Manual EMC Information NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
