Edan M3A Vital Signs Monitor

Description

Edan_M3A_Vital_Signs

EDAN_M3A_User_Manual-ES

Edan M3A Vital Signs Monitor

The EDAN M3A offers exceptional cost performance ratio, bringing together essential measurements such as SpO₂, NIBP, Pulse Rate and Temp in one compact unit. It gives care teams throughout the hospital most of the data they need, at the patient’s side.

It comes packaged with PatientCare Viewer PC Software, for real-time data transfer and storage of patient information. Includes 100 hours trend review of all parameters.

Features:

• 3.5” High resolution TFT LCD
• Clear LED numeric displays
• NIBP, SpO₂,(otional) Quick Temp (optionsl) vital sign measurements
• Adaptable to adult, child, paediatric & neonatal patients
• User-friendly interface with quick access to most commonly used functions
• Nurse call
• Spot-check & continual working modes with alarm system — meets most clinical needs
• Power saving design & standby mode provides up to 21 hours battery life
• Quiet operation
• High capability data storage
• Cable & wireless LAN network connectivity
• Easy mounting for different working environments
• Backlight control

NOTE: Thermometer not included

Key Specifications:

General

• Anti-electroshock Class 1 & internal powered design

NIBP

• Systolic, Diastolic & Mean pressure measurement
• Adjustable measurement ranges for Adult, Paediatric & Neonatal modes
• Pressure resolution 1mmHg
• Max Mean Error ±5mmHg
• Max Standard Deviation ±8mmHg
• SpO₂
  • Resolution 1%
  • Accuracy ±2 digits (adult/paediatric, 70/100% SpO2)
  • Pulse Measuring range 25 ~ 300 BPM

  Quick Temp (optional)

  • 25C ~ 45C Quick Temp measurement range
  • Oral/axillary/rectal probe.

Edan M3A Vital Signs Monitor Specifications

Classification Anti-electroshock type:Class I equipment and internally powered equipment
Anti-electroshock degree: SpO2, NIBP: BF TEMP: CF (T2 module) BF (TH module, F3000 module)
Ingress Protection IPX1 With T2, TH or F3000 TEMP module: Ordinary equipment (Sealed equipment without liquid proof)
Working system: Continuous operation equipment
Compliant with Safety Standards IEC 60601-1: 2005+A1:2012; EN 60601-1: 2006+A1: 2013; IEC 60601-1-2:2014; EN 60601-1-2: 2015; IEC 60601-2-49:2011

Specifications NOTE: The performance of the equipment with ☆ mark is determined to be essential performance. A1.2.1

Size and Weight Size (174±2) mm (W) × (235±2) mm (H) ×(189±2) mm (D)
Weight ≤ 3 kg (without battery)

Function Configuration Model Standard Function Optional Function M3A (SpO2), NIBP (TEMP) (Optional for this model)

Environment The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges.

M3A Vital Signs Monitor User Manual Specifications – 89 – 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 Working 0 °C ~ +40 °C
With TEMP: +10 °C ~ +40 °C
Transport and Storage -20 °C ~ +55 °C With TH module: -20 °C ~ +50 °C
Humidity Working 15% RH~ 95% RH (non- condensing)
Transport and Storage 15% RH~ 95% RH(non- condensing)
Altitude Working 86 kPa ~ 106 kPa
Transport and Storage 70 kPa ~ 106 kPa
Power Supply Voltage: 100 V–240 V
Frequency: 50 Hz/60 Hz Pmax: 70 VA FUSE: T2.0 AH/250 VP A1.2.4

Display

Multicolor LCD Resolution: 320×240, adjustable brightness
Messages 1 power supply indicator LED (Green) 1 power on indicator LED (Green) 1 alarm indicator LED (Cyan/Yellow/ Red) 1 alarm silence indicator LED (Yellow) 1 charge indicator LED (Yellow) 1 NIBP working status indicator LED (Backlight) 3 indicating modes correspond to alarm mode

Battery

Quantity 1 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, continuous SpO2 measuring, NIBP automatic measuring mode with the operating interval of 4 hours)
Maximum Rechargeable Period 2500 mAh: 4 h 5000 mAh: 6 h (Monitor is on or in standby mode.)

Recorder (optional)

Record width 48 mm
Paper speed 25 mm/s
Recording types Real-time data recording
Trend graph review recording
Trend table review recording
Alarm list recording

Data Storage

Trend data storage 12, 000 groups data

NIBP

Complies with IEC 80601-2-30: 2009+A1: 2013.
Mode: Manual, Auto, Continuous
Measuring interval in AUTO mode: unit: minute) 1/2/3/4/5/10/15/30/60/90/120/240/480 Continuous 5 min, interval is 5 s
Measuring type Systolic Pressure, Diastolic Pressure, Mean Pressure, Pulse Rate

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
NEO mode SYS 40 mmHg ~ 135 mmHg DIA 10 mmHg ~100 mmHg MAP 20 mmHg ~110 mmHg

Alarm type SYS, DIA, MAP, PR
Cuff Pressure measuring range 0 mmHg ~300 mmHg
Pressure resolution 1 mmHg ☆Maximum mean error ± 5 mmHg
Maximum standard deviation 8 mmHg

Maximum measuring time of single measurement:
ADU/PED 120 s
NEO 90 s

Typical measuring period 20 s ~ 35 s (depend on HR/motion disturbance) Overpressure protection:
ADU (297±3) mmHg
PED (245±3) mmHg
NEO (147±3) mmHg PR

Measuring range 40 bpm ~ 240 bpm
Accuracy ±3 bpm or 3.5%, whichever is greater

Pre-inflation Pressure:

Adult Mode Default: 160 mmHg Range: 80/100/120/140/150/160/180/200/220/240 mmHg
Pediatric Mode Default: 140 mmHg Range: 80/100/120/140/150/160/180/200 mmHg M3A Neonatal Mode Default: 100 mmHg Range: 60/70/80/100/120 mmHg

SpO2

Complies with ISO 80601-2-61: 2011.

Measuring Range 0% ~100%
Adjustable Range of Alarm Limits 0% ~100%
Resolution 1% Data update period 1s

Accuracy:
ADU & PED ±2% (70% – 100% SpO2) Undefined (0% – 69% SpO2)
NEO ±3% (70% – 100% SpO2) Undefined (0% – 69% SpO2)

Perfusion Index

Measuring Range 0-10. It displays 0 for invalid PI value.
Resolution 1 bpm
Sensor Red light (660±3) nm
Infrared light (905±10) nm E
mitted light energy < 15 mW

NOTE: The information about wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed)

PR

Measuring range

Accuracy Resolution
PR (SpO2) Measuring range: 25 bpm to 300 bpm Accuracy: ±2 bpm  Res: 1 bpm
PR (NIBP) Measuring range: 40 bpm to 240 bpm Accuracy ±3 bpm or 3.5%, whichever is greater Accuracy: 1 bpm

TEMP (optional)

Complies with ISO 80601-2-56: 2009.

T2 Module:
Measuring range
Monitor mode: 25 °C ~ 45 °C
Predict mode: 35.5 °C~ 42 °C
Working temperature 10 °C ~ 40 °C
Sensor type Oral /axillary /rectal
Adjustable Range of Alarm Limits 35.5 °C ~ 42 °C
Resolution 0.1 °C
Accuracy Monitor mode: ± 0.1 °C (25 °C ~ 45 °C) (not including transducer)
Response time < 60 s Update time 1 s ~ 2 s
Warm-up time < 10 s Time for predicting < 30 s
Calibration Self-test interval: ≤ 5 minutes
Measuring Mode: Direct Mode/ Adjusted Mode
Transient Response Time ≤ 30 s
Clinical Bias (-0.2 to -0.4) °C
Limits of Agreement 0.49 Stability 0.14 °C

NOTE: The direct mode refers to monitor mode, while adjusted mode refers to predict mode