The EDAN M3A machine can be calibrated by following the procedure outlined in the manual. If the pressure difference exceeds 3 mmHg during calibration, you should contact customer service for assistance.

This answer is automatically generated

Summary of Contents for EDAN M3A

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) can not 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 1.2.1 Environment ........................ 1 1.2.2 Power Source Requirements ..................1 1.2.3 Grounding the Monitor ....................1 1.2.4 Equipotential Grounding .....................
Page 5 4.8 System Setup ........................28 4.8.1 General Setup ......................28 4.8.2 General Alarm Setup ....................28 4.8.3 Time & Date Setup ....................28 4.8.4 Default Configuration ....................29 4.9 Maintenance ......................... 29 4.10 Standby Mode ........................33 Chapter 5 Alarm ..........................34 5.1 Alarm Modes ........................
Page 6 8.3 Measurement Limitations ....................52 8.4 Assessing the Validity of a SpO Reading ................53 8.5 SpO Alarm Delays ......................53 8.6 PI (Perfusion Index)* ......................54 8.7 SpO Setup ........................... 54 8.8 Alarm ............................ 54 8.8.1 Adjustable Range of Alarm Limits ................54 8.8.2 Alarm Information and Prompts ................
Page 7 11.1 Nurse Call ........................... 82 11.2 Network ..........................82 11.3 Central Monitoring System ....................82 Chapter 12 Accessories ........................83 12.1 SpO Accessories ....................... 83 12.2 NIBP Accessories ....................... 84 12.3 TEMP Accessories ......................85 12.4 Other Accessories ....................... 86 Chapter 13 Warranty and Service ....................
Page 8: Chapter 1 Intended Use And Safety Guidance
M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use/Indications for Use This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for SpO...
Page 9: Equipotential Grounding
And they should be familiar with the contents of this user manual before operation. 4 Only qualified service personnel can install this equipment. And only service personnel authorized by EDAN can open the shell. 5 The device must be connected to the ground to avoid signal interference. - 2 -...
Page 10 Keep it away from the monitor. 16 Do not use a battery with serious scratch 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 11 All last settings used will be recovered when the power is restored. 26 The equipment can provide protective means to prevent the patient from being burned when used with HF SURGICAL EQUIPMENT. Use only EDAN-approved accessories.
Page 12 M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING 36 The medical electrical equipment needs to be installed and put into service according to the EMC Information provided in this user manual. 37 If device conflict occurs when monitor is connected to gateway, please modify the IP address of the conflicted monitor.
Page 13 M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING 49 If several items of medical equipment are interconnected, pay attention to the sum of the leakage currents, otherwise it may cause shock hazard. Consult your service personnel.
Page 14 M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance CAUTION 8 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 15: Protecting Personal Information
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 16: Explanation Of Symbols On The Monitor
M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance NOTE: Log files generated by the monitor are used for system troubleshooting and do not contain protected medical data. 1.2.8 Explanation of Symbols on the Monitor DEFIBRILLATION-PROOF TYPE BF APPLIED PART...
Page 17 M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance Date of manufacture MANUFACTURER General symbol for recovery/recyclable Disposal method Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician. Ingress Protection IPX1 (Protected against vertically...
Page 18: Chapter 2 Installation Of Monitor
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.
Page 19: Connecting Sensor To Patient
In this case, reset the system time after powering on. 6 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. 2.4 Connecting Sensor to Patient Connect all the necessary patient sensors between the monitor and the patient.
Page 20: Chapter 3 Introduction
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.
Page 21 M3A Vital Signs Monitor User Manual Introduction M3A with the TH TEMP Module M3A with the F3000 TEMP Module Figure 3-1 M3A Vital Signs Monitor M3A Vital Signs Monitor can monitor: Oxygen saturation of arterial blood (SpO Pulse Rate (PR);...
Page 22: Screen Display
M3A Vital Signs Monitor User Manual Introduction 3.2 Screen Display The monitor is equipped with LCD. The patient parameters, waveforms, alarm messages, patient ID, time, monitor status and other information can be reflected from the screen. If the monitor has SpO , NIBP and TEMP functions.
Page 23 M3A Vital Signs Monitor User Manual Introduction The NIBP multi-group Review and SpO waveform area is displayed as follows: Figure 3-3 NIBP Multi-group Review Change the display on the screen to trend list as follows: Figure 3-4 Display Trend List...
Page 24 M3A 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 Audio alarm off Audio alarm paused Parameter alarm off Indicates an error occurs Note...
Page 25 M3A Vital Signs Monitor User Manual Introduction Parameter Area (①) Parameter area is on the upper part of main interface, and following parameters are displayed:  SpO (Unit: %)  PR (Pulse Rate, Unit: BPM).  SpO alarm limit NIBP: ...
Page 26: Optional Displays
M3A Vital Signs Monitor User Manual Introduction 3.2.2 Optional Displays - only measuring mode Figure 3-6 Display in SpO only Mode NIBP- only measuring mode In NIBP only measuring mode, the PR from NIBP measurement is also displayed on screen.
Page 27: Button Functions
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. When the monitor is off, press this button to turn it on.
Page 28 M3A Vital Signs Monitor User Manual Introduction TREND/WAVEFORM Press this button to switch among waveform display, trend ③ list and trend graph display. AUDIO ALARM Press this button to pause or turn off the auditory alarm as PAUSED/OFF needed. ④...
Page 29: Interfaces
② Figure 3-9 Sensor Connectors Connectors for cables and sensors are as shown in Figure 3-9. sensor connector ① 1. SpO 2. NIBP cuff connector ② WARNING Only connect the device to EDAN supplied or recommended accessories. - 22 -...
Page 30 ① Equipotential grounding terminal for connection with the hospital’s grounding system. ② Power supply socket: 100 V–240 V ~, 50 Hz/60 Hz. ③ USB connecting port for USB storage. ④ Network Interface: Standard RJ45 Socket, for connecting to MFM-CMS of EDAN. - 23 -...
Page 31: Built-In Rechargeable Battery
Do not place battery in the monitor with the (+) and (-) in the wrong way around. Do not heat or throw battery into fire. Only use EDAN approved rechargeable batteries for the monitor. - 24 -...
Page 32: Battery Status On The Main Screen
M3A Vital Signs Monitor User Manual Introduction WARNING Do not use, leave battery close to fire or other places where temperature may be above +60 ℃. Do not immerse, throw, and wet battery in water/seawater. 10 Do not destroy the battery, do not pierce battery with a sharp object such as a needle;...
Page 33: Checking Battery Performance
M3A Vital Signs Monitor User Manual Introduction 3.5.3 Checking Battery Performance The performance of rechargeable batteries may deteriorate over time. Battery maintenance as recommended here can help to slow down this process. 1. Disconnect the patient from the monitor and stop all monitoring and measurement.
Page 34: Chapter 4 System Menu
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.
Page 35: Recorder
M3A Vital Signs Monitor User Manual System Menu NOTE: If data storage reaches the maximum, the monitor can’t store data; the user needs to manually delete some data to continue. It is recommended to format the USB flash drive to the FAT file type via PC prior to use.
Page 36: Default Configuration
4.9 Maintenance Select Maintenance in Main Menu to open the menu. Factory Maintenance is only available for the service personnel of EDAN or representatives authorized by EDAN. User Maintenance Input the user password 9 9 8 1 in the Enter Password box and press Confirm: User Maintenance menu will pop up, in which you can set the following items.
Page 37 M3A Vital Signs Monitor User Manual System Menu When the pressure pump does not work properly and the system fails to give message for the problem, pick this item to activate self-test procedure, thus restore the system from abnormal performance.
Page 38 M3A Vital Signs Monitor User Manual System Menu  Setup Sensitivity The SpO 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 monitor responds to the changes in the patient’s oxygen saturation level.
Page 39  Exit: Exit the menu. Factory Maintenance Factory maintenance function is only available for the service personnel of EDAN or representative authorized by EDAN. Calibrating NIBP NIBP is not user-calibrated. NIBP pressure transducers must be verified at least once every two years by a qualified service professional, and calibrated, if necessary.
Page 40: Standby Mode
M3A Vital Signs Monitor User Manual System Menu 4.10 Standby Mode Entering Standby Mode When the monitor is on, and Main Menu > System Setup > General Setup > Standby Mode is set to ON, press the ON/OFF button, the dialog box displays: Sure to enter standby mode? (Press any key to return).
Page 41: Chapter 5 Alarm
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.
Page 42 M3A Vital Signs Monitor User Manual Alarm 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.
Page 43: Alarm Setup
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.
Page 44: Audio Alarm Paused
M3A Vital Signs Monitor User Manual Alarm Upon the system error, the monitor prompts alarm immediately.  C. General alert In some circumstances, alerts will behave as physiological alarms in normal senses; we do not regard them as real patient health related items.
Page 45: Alarm Reset
M3A Vital Signs Monitor User Manual Alarm  Other audible signals are not affected, including beat volume, key volume. Pressing the button again can resume the audio alarm. When Audio Alarm Off is set to OFF, this function is inactivated. The monitor has no response...
Page 46: When An Alarm Occurs
M3A Vital Signs Monitor User Manual Alarm 5.7 When an Alarm Occurs NOTE: When an alarm occurs, you should always check the patient's condition first. The alarm message appears in Information area of the screen. It is needed to identify the alarm and act appropriately, according to the cause of the alarm.
Page 47: Chapter 6 Trend And Recording
M3A Vital Signs Monitor User Manual Trend and Recording Chapter 6 Trend and Recording 6.1 Trend List The NIBP Multi-Group list is displayed as follows: Figure 6-1 NIBP Multi-Group Review Press TREND/WAVEFORM button to change the waveform to trend list.
Page 48: Recording
M3A Vital Signs Monitor User Manual Trend and Recording You can set the items below the trend graph. Item: you can set the display parameter to NIBP, SpO or PR. Y: it stands for the ordinate which indicates the displayed data range.
Page 49: Outputing The Monitoring Data
M3A Vital Signs Monitor User Manual Trend and Recording Do not leave the recorder door open unless when replacing paper or removing fault. Removing Paper Jam If the recorder works improperly or produces unusual sound, open the recorder door and check whether there is a paper jam.
Page 50: Chapter 7 Maintenance And Cleaning
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 51: General Cleaning
M3A Vital Signs Monitor User Manual Maintenance and Cleaning Maintenance and Test Schedule Frequency Check all monitoring functions At least once every two years, or as needed. and measuring functions 7.3 General Cleaning If the device or accessory has been in contact with the patient, then cleaning and disinfection is required after every use.
Page 52: Cleaning The Dust-Proof Filter Assembly
M3A Vital Signs Monitor User Manual Maintenance and Cleaning tap water after cleaning until no visible cleaning agent remains. Wipe off with a dry cloth to remove residual moisture Air dry the cuff thoroughly after cleaning. Replacing the Air Bladder:...
Page 53: Disinfection
NOTE: 1 The dust proof filter assembly is designed in the device, users can’t disassemble the device to clean. 2 If you need to replace the dust proof filter assembly, please contact EDAN’s service personnel. 7.4 Disinfection For devices or accessories that have been in contact mucosal surface, High Level disinfection...
Page 54: Disinfecting The Monitor
M3A Vital Signs Monitor User Manual Maintenance and Cleaning must occur, for all other accessories, low level disinfection is appropriate. Clean the monitor and reusable accessories before they are disinfected. The validated disinfectants for cleaning the monitor and reusable accessories are: ...
Page 55: Disinfecting The Reusable Accessories
M3A Vital Signs Monitor User Manual Maintenance and Cleaning 7.4.2 Disinfecting the Reusable Accessories 7.4.2.1 Disinfecting the Blood Pressure Cuff Disinfecting the Cuff: Take out the air bladder before disinfection. Wipe the cuff and the air bladder with a soft cloth dampened with the disinfectant solution.
Page 56: Cleaning Battery And Battery Compartment Cover
M3A Vital Signs Monitor User Manual Maintenance and Cleaning NOTE: Switch off the power of the monitor before examining the fuse. 7.6 Cleaning Battery and Battery Compartment Cover Use only non-caustic detergents such as soap and warm water (40 C /104 ℉ maximum) to clean the battery.
Page 57: Chapter 8 Spo 2 Monitoring (Optional)
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 58: Measuring Spo
M3A Vital Signs Monitor User Manual Monitoring (Optional) The device is calibrated to display functional oxygen saturation. A Functional tester or simulator cannot be used to assess the SpO accuracy. However, it can be used to demonstrate that a particular monitor reproduces a calibration curve that has been independently demonstrated to meet a particular accuracy.
Page 59: Measurement Limitations
M3A Vital Signs Monitor User Manual Monitoring (Optional) 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. All the light emitted by the light emitter must pass through the patient's tissue.
Page 60: Assessing The Validity Of A Spo Reading
M3A Vital Signs Monitor User Manual Monitoring (Optional) Move the sensor to a less active site, and keep the patient still, if possible. 8.4 Assessing the Validity of a SpO Reading You can check the quality of the pleth wave and the stability of the SpO...
Page 61: Pi (Perfusion Index)
M3A Vital Signs Monitor User Manual Monitoring (Optional) 8.6 PI (Perfusion Index)* PI is a numeric value indicating perfusion level. It reflects the perfusion level at the monitoring site. As the measurement of SpO is based on the pulsation caused by the blood flow through the vessel, PI is in relation to the strength of the pulse.
Page 62: Alarm Information And Prompts
M3A Vital Signs Monitor User Manual Monitoring (Optional) Max. Upper Limit Min. Lower Limit Step 8.8.2 Alarm Information and Prompts When there is no SpO or PR input, it prompts weak signal. Physiological alarms: Message Cause Alarm Level HIGH Medium measuring value is above upper alarm limit.
Page 63 M3A Vital Signs Monitor User Manual Monitoring (Optional) Message Cause Alarm Level What to do sensor was not Make sure the monitor and SENSOR connected well, or the sensor well connected, connection is loose. reconnect the sensor. There is interference...
Page 64: Chapter 9 Nibp Monitoring (Optional)
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) Chapter 9 NIBP Monitoring (Optional) 9.1 Introduction 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 65: Measurement Limitations
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) WARNING 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 66: Nibp Monitoring
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional)  Patients with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery.  Patients on an edematous extremity. 9.4 NIBP Monitoring To obtain accurate measurements, the following operating steps need to be observed: 1.
Page 67: Operation Prompts
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) 4. Wait until the first reading is taken. NOTE: The width of the cuff is either approximately 40% of the limb circumference or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 80%-100% of the limb.
Page 68: Correcting The Measurement If Limb Is Not At Heart Level
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional)  To stop measuring: During measuring press the NIBP START/STOP on the front panel at any time to stop measurement. 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.
Page 69: Alarm Information And Prompts
M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) 10 mmHg ~180 mmHg 20 mmHg ~195 mmHg Neonatal Mode 40 mmHg ~ 135 mmHg 10 mmHg ~ 100 mmHg 20 mmHg ~ 110 mmHg Default NIBP alarm limits: ADU (mmHg)
Page 70 M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) Technical alarms: (display in the area below the NIBP value): Alarm What to do Message Cause Level Stop using measuring function of NIBP COMM NIBP module failure or NIBP module; notify biomedical...
Page 71 M3A Vital Signs Monitor User Manual NIBP Monitoring (Optional) Alarm What to do Message Cause Level Measuring time MEASURE Measure again or use other exceeded 120 s (adult) TIMEOUT measuring methods. or 90 s (neonatal). Measure again, if failure persists,...
Page 72: Chapter 10 Temp Monitoring (Optional)
10.1 TEMP Monitoring with T2 Module 10.1.1 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.
Page 73: Measuring Procedure
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) WARNING 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. 10 Make sure you have set the correct measuring position before you start a measurement, or the result will be inaccurate.
Page 74: Temp Setup
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) After Predict measuring is over, the measuring result displays, and MEASURE OVER appears on the interface. 6 If the predict measuring is successfully finished, the monitor enters monitor mode after 30s;...
Page 75 M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) 10.1.4.2 Alarm Information and Prompts WARNING In monitoring mode, no physiological alarms are available. Physiological alarms: Message Cause Alarm Level TEMP HIGH Measuring value of TEMP is above upper alarm limit.
Page 76: Temp Monitoring With Th Module
The alarm of TEMP is turned off. 10.2 TEMP Monitoring with TH Module 10.2.1 Introduction M3A with the TH module (Infrared Ear Temperature Module) takes a temperature in the ear. Diagram of the Infrared Ear Thermometer Batter Cover Pin Hole WARNING Keep the probe covers away from children.
Page 77: Measuring Procedure
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) WARNING Only use the disposable probe covers supplied or recommended by EDAN. Use of other manufacturer’s probe covers, reuse of disposable probe covers or absence of probe covers may produce temperature measurement errors and/or inaccuraies.
Page 78 M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) 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).
Page 79: Temp Setup
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) The device must stay in stable ambient (room) temperature for 30 minutes before operation. Before the measurement, please stay in a stable environment for five minutes and avoid exercise or bath for 30 minutes.
Page 80: Replacing The Battery
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) Technical alarms: Message Cause Alarm Level What to do Check the integrity of the The TEMP value is TEMP EXCEED probe cover, make sure it is beyond the range of Medium...
Page 81: Temp Monitoring With F3000 Module
10.3 TEMP Monitoring with F3000 Module 10.3.1 General Information M3A with the F3000 module measures patient temperatures by oral, axillary or rectal means. The electromagnetic compatibility of this device has been verified by test according to the EN60601-1-2: 2015 requirements.
Page 82: Probe Covers -Applying & Removing
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) NOTE: 1 Even though this device has been designed to minimize the effects of electromagnetic interference, it does generate radio frequency energy. If not used in accordance with the instructions, the device could cause interference in other equipment operating within its vicinity.
Page 83: Measuring Mode
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) Oral and Axillary temperature taking. The Red probe and Red isolation chamber must only be used for Rectal temperature taking. Do not attach a Red probe to a Blue isolation chamber or vice-versa.
Page 84: Measuring Procedure
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) stabilizes: When the monitor operates in Predictive Mode, no measurement site is detected or the temperature does not stabilize. When the monitor operates in Predictive Mode or Quick Predictive Mode, the ambient temperature is greater than 35 °...
Page 85 M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) the arm as shown. 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.
Page 86: Temp Setup For F3000 Module
M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) 10.3.7 TEMP Setup for F3000 Module Click TEMP Setup in the Main Menu, and the following settings are available: Mode: Set the measuring mode to Predict, Quick Predict or Monitor. Position: Set the measuring position to Oral, Axillary or Rectal.
Page 87 M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) Technical alarms: Message Cause Alarm Level What to do Stop using measuring function TEMP module TEMP module; notify Temp COMM failure High STOP biomedical engineer communication Manufacturer’s service staff. failure. The TEMP value is...
Page 88 M3A Vital Signs Monitor User Manual TEMP Monitoring (Optional) Message Cause Alarm Level What to do out of range. Temp Error P04 Temp Error P03 Predict Mode heater thermistor unstable or out of range. Temp Error P05 Prompts: Message Cause...
Page 89: Chapter 11 Other Functions
M3A 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 90: Chapter 12 Accessories
M3A Vital Signs Monitor User Manual Accessories Chapter 12 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 their casing that are intended for single use; or only use them on a single patient. Reuse may compromise device functionality and system performance and cause a potential hazard.
Page 91: Nibp Accessories
M3A Vital Signs Monitor User Manual Accessories Part Number Accessories 01.57.471235 SHD-A SpO Sensor, adult, disposable 01.13.036336 SpO adapter cable, extended (Lemo to DB9) 02.01.210673 SH3 Neonate Wrap SpO Sensor 12.2 NIBP Accessories Part Number Accessories 01.57.471326 NIBP Cuff, E5, Infant, 10-15 cm, reusable 01.57.471327 NIBP Cuff, E6, Small child, 13-17 cm, reusable...
Page 92: Temp Accessories
M3A Vital Signs Monitor User Manual Accessories 12.3 TEMP Accessories Part Number Accessories T2 Module 02.01.110130 Temperture Probe, Rectal, FT20 02.01.110131 Temperture Probe, Oral/Axillary, FT10 01.57.110159 Probe Covers, WelchAllyn REF #05031 TH Module 01.13.036415 Infrared Ear Thermometer Communication Cable 01.57.208057 Infrared Ear Thermometer 01.57.208058...
Page 93: Other Accessories
M3A Vital Signs Monitor User Manual Accessories 12.4 Other Accessories Part Number Accessories 01.57.78035 Printing Paper 01.13.36014 Power Cable (IEC Standard) ,1.8 m 01.13.036106 Power cord (USA), 1.8 m 01.21.064142 Rechargeable Lithium-Ion Battery/ TWSLB-002 (14.8 V, 2500 mAh) 01.21.064143 Rechargeable Lithium-Ion Battery/ TWSLB-003 (14.8 V, 5000 mAh) 01.13.01950...
Page 94: 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 95: Appendix I Specifications
M3A Vital Signs Monitor User Manual Specifications Appendix I Specifications A1.1 Classification Anti-electroshock type Class equipment internally powered equipment Anti-electroshock degree , NIBP: BF TEMP: CF (T2 module) BF (TH module, F3000 module) Ingress Protection IPX1 With T2, TH or F3000 TEMP module: Ordinary...
Page 96: A1.2.4 Display
M3A Vital Signs Monitor User Manual Specifications When the monitor and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products. Temperature 0 C ~ +40 C (32 ℉~104 ℉) Working With TEMP: +10 C ~ +40 C (50℉~104℉)
Page 97: A1.2.5 Battery
M3A Vital Signs Monitor User Manual Specifications A1.2.5 Battery Quantity Type Li battery Capacitance Standard: 2500 mAh; Optional: 5000 mAh Typical Working Period 2500 mAh: 9 h; 5000 mAh: 18 h (With a new fully charged battery, at 20 C~30 C,...
Page 98 M3A Vital Signs Monitor User Manual Specifications ☆Measuring range ADU mode SYS 40 mmHg ~270 mmHg DIA10 mmHg ~ 215 mmHg MAP 20 mmHg ~235 mmHg PED mode SYS 40 mmHg ~230 mmHg DIA 10 mmHg ~180 mmHg MAP 20 mmHg ~195 mmHg...
Page 99: A1.2.9 Spo
M3A Vital Signs Monitor User Manual Specifications Neonatal Mode Default: 100 mmHg Range: 60/70/80/100/120 mmHg A1.2.9 SpO Complies with ISO 80601-2-61: 2011. ☆Measuring Range 0% ~100% ☆Adjustable Range of Alarm Limits 0% ~100% Resolution Data update period ☆Accuracy 2% (70% - 100% SpO ADU &...
Page 100: A1.2.11 Temp
M3A Vital Signs Monitor User Manual Specifications A1.2.11 TEMP Complies with ISO 80601-2-56: 2009. T2 Module: Monitor mode: 25 C ~ 45 C ☆Measuring range Predict mode: 35.5 C~ 42 C 10 C ~ 40 C Working temperature Sensor type Oral /axillary /rectal 35.5 C ~ 42 C...
Page 101 M3A Vital Signs Monitor User Manual Specifications Response time  0.2 C (0.4 °F) (35.5 C ~42 C) (95°F ☆Clinical Accuracy -107.6 °F)  0.3 C (0.5 °F) (out of the range mentioned above) Measuring Mode Adjusted Mode F3000 Module: 30 C~43 C...
Page 102: Appendixⅱ Emc Information - Guidance And Manufacture's Declaration
A2.1 Electromagnetic Emissions Guidance and manufacture’s declaration – electromagnetic emission 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. Electromagnetic environment – guidance...
Page 103 M3A Vital Signs Monitor User Manual EMC Information Electromagnetic Immunity test IEC/EN 60601 test level Compliance level environment guidance  8 kV contact  8 kV contact Electrostatic Floors should be wood, discharge (ESD) concrete or ceramic tile.  15 kV air ...
Page 104: A2.3 Electromagnetic Immunity
A2.3 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity 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. IEC/EN 60601 test...
Page 105 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which M3A is used exceeds the applicable RF compliance level above, M3A should be observed to verify normal operation.
Page 106 M3A Vital Signs Monitor User Manual EMC Information Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Service Modulation Maximum Distance Immunity frequency (MHz) power test level (MHz) (V/m) Pulse 380-390 TETRA 400 modulation 18 Hz ±...
Page 107: A2.4 Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and M3A M3A is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of M3A can help prevent electromagnetic interference...
Page 108: Appendix Iii Abbreviation
M3A Vital Signs Monitor User Manual Abbreviation Appendix III Abbreviation Abbr English Full Name/Description Alternating current Adult Arterial Left foot augmented lead Left arm augmented lead Right arm augmented lead Burst count Blood pressure BTPS Body temperature and pressure, saturated...
Page 109 M3A Vital Signs Monitor User Manual Abbreviation Abbr English Full Name/Description End-tidal oxygen Federal Communication Commission Food and Drug Administration Fraction of inspired FiCO Fraction of inspired carbon dioxide Fraction of inspired nitrous oxide Fraction of inspired oxygen Halothane Hemoglobin...
Page 110 M3A Vital Signs Monitor User Manual Abbreviation Abbr English Full Name/Description NIBP Non-invasive blood pressure Oxygen Operating room oxyCRG Oxygen cardio-respirogram Pulmonary artery PACU Post-anaesthesia care unit PAWP Pulmonary artery wedge pressure Pediatric Pleth Plethysmogram Pulse rate Premature ventricular complex...

EDAN M3A User Manual

Chapter 1 Intended Use and Safety Guidance

Chapter 2 Installation of Monitor

Chapter 3 Introduction

Chapter 4 System Menu

Chapter 5 Alarm

Chapter 6 Trend and Recording

Chapter 7 Maintenance and Cleaning

Chapter 8 Spo 2 Monitoring (Optional)

Chapter 9 NIBP Monitoring (Optional)

Chapter 10 TEMP Monitoring (Optional)

Chapter 11 Other Functions

Chapter 12 Accessories

Chapter 13 Warranty and Service

Appendix I Specifications

Appendixⅱ EMC Information - Guidance and Manufacture's Declaration

Appendix III Abbreviation

Quick Links

Need help?

Questions and answers

Related Manuals for EDAN M3A

Summary of Contents for EDAN M3A

Table of Contents