15-Inch Multi-Parameter Patient Monitor For ICU and General Diagnosis SM-PM09

1. Product Overview

• Product Name: SM-PM09 Multi-parameter Patient Monitor (15 inches)
• Technical Data Sheet Version: Release V2.4
• Applicable Environments: Adult, pediatric, and neonatal intensive care; anesthesia and peri-operative care; OR and cardiac care environments
• Certifications: CE/ISO/RoHS/CFDA

2. Core Features

2.1 Core System

• Newly advanced A9 main board with Linux OS, calculating speed is 4 times faster than traditional products
• Support storage of 2160 hours trend table and graph review, 2 hours waveform review, 2000 groups NIBP review and 2000 alarm events review

2.2 Body & Display

• 15 inch high-brightness TFT LED
• Support display 9~13 waveforms
• Support 7 channel ECG waveform display simultaneously
• Optional HDMI output

2.3 Printer (Built-in)

• Type: High-speed 50mm thermal printer
• Brand: SEIKO (Japan)

2.4 Central System

• Optional Build-in wireless network module, supporting wired or wireless connection to the central monitoring station
• Optional Support HL7 (Health Level Seven)

2.5 Alarm

• Double high light alarm light bar
• Three-level acousto-optic alarm
• Sensor-off alarm
• Paper out alarm
• Support alarm review
• Support alarm pause

2.6 Linux OS Functions

• Support operation with mouse and computer keyboard (option)
• Multi-display mode to meet different clinical requirement, including standard interface, big font, OxyCRG, trend graph, NIBP review and full leads ECG interface
• NIBP self-test mode: including overpressure test, static pressure test and air leakage test
• Generate ID automatically when register a new patient
• Support medical history search by patient ID, name and mobile number
• 18 types of Arrhythmia analysis and real-time S-T segment analysis and pacemaker detection
• Drug calculation and titration table
• Support multi-language display
• Support online software upgrading by net/USB

2.7 Service Features

• The Support Tool helps technical personnel to – carry out configuration, upgrades and troubleshooting on an individual monitor; back up the monitor settings
• The Service Mode is password-protected and ensures that only trained staff can access service tests and tasks. It includes Skin Type, Brightness Setting, Clear Data and NIBP Calibration
• The Support Tool uses the USB interface of the monitor for software upgrading

3. Performance Specifications

3.1 Dimension and Weight

• Dimension: 393mm382mm173mm
• Weight: 4.5kg (excluding accessories)

3.2 Power Supply

• Voltage: AC100~240V, 50/60HZ
• Power: ≤60W

3.3 Display

• Screen: 15″ color TFT LED
• Resolution: 1024*768 pixels

3.4 Battery (Pluggable)

• Type: Rechargeable lithium battery 14.8V/2200mAh
• Charge Cycle: ≥500 times
• Working time: 2 hours (optional larger battery for 4-5 hours)

3.5 Recorder (Option)

• Method: Thermal printer
• Paper width: 50 mm (1.97 in)
• Printing speed: 12.5/ 25/ 50 mm/s
• Trace: Max. 3 tracks
• Recording way: Real-time Recording, Review Printing, Periodic Recording, Alarm Recording

3.6 Alarm Details

• Level: Low, medium and high
• Indication: Auditory and visual
• Alarm volume: Adjustable
• Alarm pause time: 1min, 2min
• Parameter alarm type: Latch/ Unlatch

3.7 Input Device

• Knob (Standard)
• Keypad input (Standard)
• Mouse/ Keyboard input (option)

3.8 System Output & Extensible Interface

• Ethernet Network: 1 standard RJ45 socket
• USB Port: 1
• Video Output: 1 HDMI port (option)

3.9 Operating Environment

• Temperature: 5 ~ 40 ℃
• Humidity: 15% ~ 80% (non-condensing)
• Atmosphere pressure: 86 KPa ~ 110 KPa

3.10 Transportation and Storage Environment

• Temperature: -20~50 ℃
• Humidity: 10%~90% (non-condensing)
• Atmosphere pressure: 86 KPa ~ 110 KPa

3.11 Safety

• IEC60601-1 Approved, CE marking according to MDD93/42/EEC
• With reference to RoHS Directive 2011/65/EU recasting

3.12 Trend & Reviewing

• Trend: 2160 hours
• ARR events: 128 groups of ARR events and associated waveform
• NIBP measurement reviewing: 2000 groups
• Waveform review: 2 hours
• Alarm event: 2000 groups of parameter alarms events and associated parameter

4. Monitoring Parameters Specifications

4.1 ECG

• Lead mode: 3/5 Leads (I, II, III or I, II, III, AVR, AVL, AVF, V)
• Protection: Breakdown Voltage 4000VAC 50/60Hz; Defibrillator proof
• Gain: 2.5mm/mV (×0.25), 5.0mm/mV (×0.5), 10mm/mV (×1), 20mm/mV (×2), 40 mm/ mV (×4), Auto
• Sweep speed: 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s
• ECG signal range: ±12 mV (Gain × 0.25)
• Accuracy: ±1bpm/ ±1%, whichever is greater
• Resolution: 1 bpm
• Leakage Current: < 10 μA
• Baseline Recovery: ≤3s after defibrillation (Monitor mode); ≤1s after defibrillation (Surgery mode)
• Bandwidth: Surgery 1 ~ 25 Hz; Monitor 0.5 ~ 40 Hz; Diagnostic 0.05 ~ 120 Hz
• Indication of Electrode Separation: Every electrode (exclusive of RL)

4.2 Heart Rate

• Measure range: Adult: 0bpm, 10 ~ 300 bpm; Neo/Ped: 0bpm, 10 ~ 350 bpm
• Resolution: 1 bpm
• Accuracy: ± 1% or ± 1bpm, whichever is greater

4.3 ST Measurement

• Range: -2.0 ~ +2.0 mV
• Accuracy: -0.8mV ~+0.8mV: ±0.02mV or ±10%, whichever is greater; Other range: unspecified
• Resolution: 0.01mV

4.4 Respiration

• Method: Impedance between RA-LL, RA-LA
• Gain: ×0.25, ×0.50, ×1, ×2, ×4
• Respiration Rate: 0bpm, 6 ~ 150 BrPM
• Sweep speed: 6.25 mm/s, 12.5 mm/s, 25mm/s
• Resolution: 1 BrPM
• Accuracy: ±2 bpm or ±2%, whichever is greater
• Apnea Alarm: 10 ~ 60 s

4.5 NIBP

• Method: Oscillometric
• Measure mode: Manual, Auto, STAT
• Measure Interval in AUTO Mode: 1~480 min
• STAT mode cycle time: Keep 5 minutes, at 5 seconds interval
• Measure and Alarm Range:

  Group	Parameter Range
  Adult	SYS: 30 ~ 270 mmHg; DIA: 10 ~ 220 mmHg; MEAN: 20 ~ 235 mmHg
  Pediatric	SYS: 40 ~ 235 mmHg; DIA: 10 ~ 220 mmHg; MEAN: 20 ~ 225 mmHg
  Neonate	SYS: 30 ~ 135 mmHg; DIA: 10 ~ 110 mmHg; MEAN: 20 ~ 125 mmHg

• Static pressure accuracy: ±3mmHg
• Resolution: 1mmHg
• Accuracy: Maximum Mean error ±5mmHg; Maximum Standard deviation ≤8mmHg
• Over pressure Protection: Dual protection via software & hardware

4.6 Temperature

• Technique: Thermistor probe (2.25K)
• Channel: Dual-Channel, provide T1; T2; ΔT
• Measuring and Alarm Range: 0.0 ℃~ 50 ℃ (32℉~ 122℉)
• Unit: Celsius (℃), Fahrenheit (℉)
• Resolution: 0.1℃ or 1℉
• Accuracy: ±0.1℃ (exclusive probe)

4.7 SpO2 (Digital Technic)

• Measurement Range: 0 ~ 100 %
• Resolution: 1 %
• Response Modes: Low, Medium, High
• Accuracy: ±2% (70% ~ 100%); ±3 % (35% ~ 69%); Unspecified (0 ~ 34%)
• Support Pitch tone and multi-level volume

4.8 Pulse Rate

• Measuring and Alarm Range: 25~250bpm
• Accuracy: ±1% or ±1 bpm, whichever is greater
• Resolution: 1bpm

4.9 Nellcor-SpO2 (Option)

• Measurement Range: 0 ~ 100 %
• Resolution: 1 %
• Accuracy: 70% ~ 100%, ±2 % (adult); 70% ~ 100%, ±3 % (Neonate); 70% ~ 100%, ±2 % (Low Perfusion); 0% ~ 69%, unspecified
• Pulse Rate (Nellcor-SpO2):
  • Measurement range: 20 ~ 300 bpm
  • Resolution: 1bpm
  • Accuracy: ±3 bpm (20 ~ 250 bpm); unspecified (251~300 bpm)

4.10 Masimo SpO2 (Option)

• Measurement Range: 0 ~ 100 %
• Resolution: 1 %
• Accuracy: 70% ~ 100%, ±2 % (adult/ pediatric, non-motion conditions); 70% ~ 100%, ±3 % (neonate, non-motion conditions); 70% ~ 100%, ±3 % (motion conditions); 0% ~ 69% unspecified
• Pulse Rate (Masimo SpO2):
  • Measurement range: 25 ~ 240 bpm
  • Resolution: 1bpm
  • Accuracy: ±3 bpm (non-motion condition)

4.11 EtCO2 (Mainstream/ Sidestream) (Option)

• Measure method: Non-dispersive infrared (NDIR)
• Measure Range: 0 ~19.7% (0 ~ 150 mmHg), 0 ~ 20 kPa
• Resolution: 0.1 mmHg
• CO2 Accuracy: 0 ~ 40 mmHg, ±2 mmHg; 41 ~ 70 mmHg, ±5% of reading; 71 ~ 100 mmHg, ±8% of reading; 101~ 150 mmHg, ±10% of reading (at 760 mmHg, ambient temperature of 25℃)
• Respiratory Rate: Range: 3 ~150 BrPM; Accuracy: ±1 bpm

4.12 EtCO2 (Micro-stream) (Option)

• Measure method: Non-dispersive infrared (NDIR)
• Measure Range: 0 ~19.7% (0 ~150 mmHg), 0 ~ 20 kPa
• Sample Rate: 50 mL/min ±10mL/min
• Resolution: 0.1 mmHg (0 ~ 50 mmHg); 0.25 mmHg (50 ~ 114 mmHg)
• CO2 Accuracy: 0 ~ 40 mmHg, ±2 mmHg; 41 ~ 70 mmHg, ±5% of reading; 71 ~ 100 mmHg, ±8% of reading; 101~ 150 mmHg, ±10% of reading (at 760 mmHg, ambient temperature of 35℃)
• Respiratory Rate: Range: 3 ~120 BrPM; Accuracy: ±1 bpm

4.13 Depth of Anesthesia (CSI) (Option)

• EEG sensitivity: ± 400μV
• Noise: < 2μVp-p, < 0.4μV RMS, 1-250 Hz
• CMRR: > 140 dB
• Input impedance: > 50 Mohm
• Sample rate: 2000 samples/sec, (14 bits equivalent)
• BS%: 0-100, filter 1-42 Hz, 1 sec. display update
• EMG: 0-100 Logarithmic. Filter 75-85 Hz, 1 sec. update
• Alarms: High / Low with user selectable limit
• Artifact rejection: Automatic
• Sensor impedance range: 0 – 10 kOhm / measurement current 0.01 μA

4.14 Multi-gas/O2 (Anesthetic Gas) (Option)

• Method: Infrared absorption
• Gas sorts: CO2, N2O, Des, Iso, Enf, Sevo, Hal, O2 (Optional paramagnetic sensor)
• Calibration: Room air calibration performed automatically when changing airway Airway adapt (< 5 sec)
• Measurement range: CO2: 0~25%; N2O: 0~100%; O2: 0~100%; Enf, Iso, Hal: 0~25%; Sevo, Des: 0~25%
• Data output: Fi and ET values
• Respiration rate: 0~ 150 BrPM
• Other: Up to 5 waveforms displayed; Agent mixture detection; MAC value displayed

4.15 IBP (Option)

• Max Channel: 2
• Measurement way: Thermal resistance way
• Press Sensor: Sensitivity 5 uV/V/mmHg, ±2%; Impedance 300 to 3000Ω
• Resolution: 1 mmHg
• Unit: mmKg, kPa, cmH2O
• Transducer sites: Arterial Pressure (ART); Pulmonary Arterial (PA); Left Arterial (LAP); Right Arterial (RAP); Central Venous Pressure (CVP); Intracranial Pressure (ICP); P1/ P2
• Measuring and alarm range:
  • ART: 0 ~ +350mmHg
  • PA: -10 ~ +120 mmHg
  • CVP/ RAP/ LAP/ ICP: -10 ~ +40 mmHg
  • P1/ P2: -50 ~ +350mmHg
• Accuracy:
  • Static: ±1mmHg or ±2%, whichever is greater (exclusive of transducer); ±4mmHg or ±4%, whichever is greater (inclusive of transducer)
  • Dynamic: ±4mmHg or ±4%, whichever is greater

5. Model Configuration