Specification: K1

SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD

Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to
Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue,
Matian Sub-district, Guangming District, Shenzhen, Guangdong,
518106,P.R. China
Tel: +86-755-26408879
Fax:+86-755-26431232
Email: info@szcomen.com
Web: www.comen.com

2021 V 1.3
 Transport Monitor
K1

Physical Characteristics Defib. recovery ≤ 5 seconds

Size 148.4mm×79.2mm×96.5mm time
Weight About 2.5Kg (with Portable Plug-in ESU recovery time ≤ 10 s
Box and Docking Station) Response time to
Display HR changes
Type Medical-grade color TFT LCD, Provide Glasgow resting 12-lead ECG algorithm.
capacitive touch screen, support Heart Rate
multi-touch operation. HR range Adult: 15~300bpm
Screen Size 5.5-inch TFT touch screen Pediatric/Neonate: 15~350bpm
Resolution 1280 × 720 HR accuracy ±1% or ±1bpm, whichever is greater
Waveforms 5 waveforms HR resolution 1 bpm
Brightness Level 1~10 Arrhythmia Analysis
ECG Intended use for adult, pediatric and neonate
Meet standards of IEC 60601-2-27 and IEC 60601-2-25. Multi-lead ECG monitoring analysis algorithm
Lead Type 3-Lead: I; II; III 27 classifications including:
Asystole, Vfib/Vtac, PVCs/min too high, R on T, VT>2, Run
5-Lead: I; II; III; aVR; aVL; aVF; V
PVCs, Couplet, PVC, Bigeminy, Trigeminy, Tachy, Brady,
6-Lead: I; II; III; aVR; aVL; aVF; Va; Vb
Extreme Tachy, Extreme Brady, extreme bradycardia, Missed
12-Lead: I; II; III; aVR; aVL; aVF; V1-V6
beats, multiform PVC, V-Tach, Nonsus V-Tach, Vent Rhythm,
Auto
Heart Pause, Pause/min high, Irr Rhythm, Vent Brady, A-Fib,
Sweep Speed 6.25,12.5, 25, 50mm/s, error≤±10%
Pacer Not Capture, Pacer Not Pacing, Irr Rhythm End and A-
Gain X0.125, X0.25, X0.5, X1, X2, X4, auto,
Fib End.
error≤±5%
ST Segment Analysis
Waveform format Standard, Cabrera
Intended use for adult, pediatric and neonate
Input signal range ±10mV (p-p)
ST range -2.5mV ~ +2.5mV (Automatic)
Electrode offset ±850mV
ST accuracy ±0.02mV or ±10%, whichever is greater
potential
(- 0.8 mV ~ + 0.8 mV)
tolerance
ST resolution 0.01 mV
CMRR Diagnostic mode: >90dB
QT/QTc Analysis
Monitor, Surgical, ST mode: >106dB
Intended use for adult, pediatric and neonate
Bandwidth Monitor mode: 0.5~40Hz
Parameters QT, QTc, ∆QTc
(Frequency) Diagnosis mode: 0.05~150Hz
QTc formula Bazett, Fridericia, Framingham, or
Surgery mode:1~20Hz
Hodges
ST mode: 0.05~40Hz
QT/QTc range 200~800ms
Pace detection Amplitude: ± 2 mV ~ ± 700 mV
QT accuracy ± 30ms
(without Width: 0.1~2ms
QT resolution 4 ms
overshoot) Rise time: 10~100μs
QTc resolution 1 ms
Defib. Protection Withstand 5000VAC (360J)
QT-HR range QT-HR: Adult 15~150bpm
defibrillation
 Pediatric/Neonate: 15~180bpm Suntech NIBP
Respiration Max Adult: 130s
Lead I, II, or auto (default: lead II) measurement Pediatric: 90s
Method RA-LL Impedance Method time Neonate: 75s
RR range 0~200bpm Suntech Adult Mode: 40~260mmHg
RR accuracy 0~120r Systolic range Pediatric Mode: 40~160mmHg
RR resolution 1 rpm Neonate Mode: 40~130mmHg
Apnea Alarm Time Adult: 10~60s, resolution 5s Suntech Adult Mode: 20~200mmHg
Pediatric/Neonate: 10~40s, resolution Diastolic range Pediatric Mode: 20~120mmHg
5s Neonate Mode: 20~100mmHg
Sweep speed 3, 6.25, 12.5, 25, 50mm/s Suntech Adult Mode:26~220mmHg
NIBP Mean range Pediatric Mode:26~133mmHg
Meet standard of ISO 80601-2-30. Neonate Mode 26~110mmHg
Method Automatic oscillation Suntech Adult/Pediatric Mode:
Work mode Manual, Auto(Periodic), Over-pressure 297mmHg±3mmHg
continuous(STAT), Sequence, Hourly protection Neonate Mode:
Parameters Systolic, Diastolic, Mean 147mmHg±3mmHg
Measurement 1-720min (Adjustable) Suntech Adult: 120~280 mmHg
Time Initial pressure Pediatric: 80~170 mmHg
Measurement mmHg / kPa selectable range(mmHg) Neonate:60~140 mmHg
Unit SpO2
Static range 0~300mmHg(0kPa~40.0kPa) Meet standard of ISO 80601-2-61.
NIBP accuracy ±3mmHg(±0.4kPa) SpO2 module Comen, Masimo, Nellcor SpO2
NIBP resolution 1 mmHg Range 0~100%
Venous Puncture Yes Resolution 1%
Comen NIBP Accuracy Ped/Adu: ±2% (70~100%)
Max Adult/ Pediatric: 120s Neo: ±3% (70~100%)
measurement Neonate: 85s Alarm range 1~100%
time Perfusion Index Yes, for Comen and Masimo SpO2
Comen Adult Mode: 25~290mmHg Pitch tone Yes
Systolic range Pediatric Mode: 25~250mmHg Response time <30s
Neonate Mode: 25~140mmHg
Data update time 1s
Comen Adult Mode: 10~250mmHg
Dual-SpO2 Yes, SpO2, SpO2b, ΔSpO2
Diastolic range Pediatric Mode: 10~210mmHg
Neonate Mode: 10~115mmHg PR
PR range 30-310bpm (Comen NIBP)
Comen Adult Mode:15~260mmHg
Mean range Pediatric Mode:15~225mmHg 30-220bpm (Suntech NIBP)
Neonate Mode 15~125mmHg 20-300pm (Comen SpO2)
Comen Adult/ Pediatric Mode: 25-240pm (Masimo SpO2)

Over-pressure 297mmHg±3mmHg 20-300bpm (Nellcor SpO2)

protection Neonate Mode: 20-350bpm (IBP)

147mmHg±3mmHg Accuracy ±3bpm or ±3%, whichever is greater

Comen Adult: 80~290 mmHg (Comen NIBP)

Initial pressure Pediatric: 80~240 mmHg ±3bpm or ±2%, whichever is greater
range(mmHg) Neonate:60~140 mmHg (Suntech NIBP)
±2bpm (Comen SpO2)
 awRR range 0~150rpm
awRR accuracy ±1rpm
±3bpm (Masimo SpO2 non-motion) Sampling rate 50ml/min
±5bpm (Masimo SpO2 motion) Sampling rate ±10 ml/min
±3bpm (Nellcor SpO2) accuracy
±1bpm or ±1%, whichever is greater Data sampling 20Hz/each channel
(IBP) rate
Temperature (Dual Channel) System total <3s (2m sampling line)
Meet standard of ISO 80601-2-56. response time
Technique Thermal resistance IBP
Channels 2 channels Meet standard of IEC 60601-2-34.
Temp range 0~50°C Channel Up to 4 Channels
Temp accuracy ±0.1°C or ±0.2°F Sensitivity 5 µV/V/mmHg
Temp resolution 0.1°C Impedance range 300 to 3000Ω
Refreshing rate 1s IBP Range -50mmHg~370mmHg
Sensor type CY, YSI IBP accuracy ±2% or ±1mmHg (whichever is
EtCO2 greater)
Meet standard of ISO 80601-2-55. IBP resolution 1mmHg
EtCO2 module Comen, Masimo, Respironics PPV range 0~50%
Unit mmHg, kPa
SPV range 0-50mmHg
Comen/Respironics Mainstream EtCO2 (only for
PAWP Yes
Portable Plug-in Box)
Measured ART, PA, CVP, RAP, LAP, ICP, LV, AO,
Rise time <60ms
Pressure UAP, BAP, FAP, UVP, IAP, CPP, P1, P2,
CO2 range 0mmHg~150mmHg
P3, P4
CO2 resolution 1mmHg or 0.1kPa or 0.1%
Cardiac Output (C.O.) (only for Portable Plug-in Box)
CO2 accuracy 0mmHg ~40mmHg should be±2mmHg
Method Thermodilution
41mmHg ~70mmHg should be±5%
Measurement C.O.: 0.1~20L/min
71mmHg ~100mmHg should be±8%
range BT: 23~43℃(73℉～109℉)
101mmHg~150mmHg should be±10%
IT: 0~27℃
awRR range 0~150rpm
Accuracy C.O.: ±5% or ±0.1L/min, whichever is
awRR accuracy ±1rpm
greater
sample rate 50ml/min
BT: ±0.1℃(±0.2℉)
Accuracy ±10 ml/min
IT: ±0.1℃
Masimo Mainstream EtCO2 (only for Portable Plug-in Box)
C.O. measure Auto, Manual
CO2 range 0mmHg~190mmHg, 0vol%~ 25vol%
mode
(at 760mmHg)
IT source Auto, Manual
CO2 Accuracy 0mmHg ~114mmHg, ± (2.25 mmHg
BT alarm range: 23~43℃
+4%xreading)
resolution: 0.1℃
115~190mmHg: undefined
Impedance Cardiograph (ICG)
awRR range 0~150rpm
Technique impedance cardiogram
awRR accuracy ±1rpm
Masimo Capno Sidestream EtCO2 Parameters ACI, VI, PEP, LVET, TFI, TFC, HR, C.O.,
C.I., SV, SVI, SVR, SVRI, PVR, PVRI,
CO2 range 0~190mmHg, LCW, LCWI, LVSW, LVSWI, STR, VEPT.
0%~25% (at 760mmHg) C.O. range HR: 40 to 250 bpm
CO2 accuracy 0~114mmHg: ± (2.25 mmHg C.O: 0 to 30L/min
SV: 5 to 250mL
+4%xreading)
Accuracy HR: ±2bpm
115~190mmHg: undefined C.O.: Unspecified
SV: unspecified
CO2 range 0~25% The concentration of any identified
CO2 accuracy ±(2%+reading×2%), 15~25%: anesthetic gas will be reported, even if
undefined it is lower than 0.15 vol%.
N2O range 0~100 % BIS (only for Portable Plug-in Box)
N2O accuracy ±(2%+reading×3%) Measurement BIS: 0~100, accuracy: 1
O2 range 0~100 % range SQI: 0~100%, accuracy: 1%
O2 accuracy ±(1%+reading×3%) EMG: 0~100dB, accuracy: 1dB
ENF/ISO range 0~8% ESR: 0~100%, accuracy: 1%

ENF/ISO accuracy ±(0.2%+reading×5%) Resolution 1

SEV range 0~8% Alarm range BIS: 0~100; resolution: 5

SEV accuracy ±(0.15%+reading×5%) RM (Respiratory mechanics) (only for Portable Plug-in

Box)
DES range 0~16%
Measured Paw(airway pressure):
DES accuracy ±(0.15%+reading×8%)
Parameters PIP, Pplat, PEEP, Pmean
HAL range undefined
Flow(airway flow):
HAL accuracy undefined
PIF, PEF
awRR range 0~150rmp
VOL(airway volume):
awRR resolution 1rpm TVi, TVe, MVi, MVe
Multi-gas (Masimo) Sidestream (only for Portable Plug- Others:
in Box) RR, I:E, Compl, FEV1.0, RSBI, WOB, Raw
Method Infrared Gas Measurement PIP, PEEP, Pplat, -20~100cmH2O
Data Output Pmean accuracy: ±1cmH2O/±5%xreading,
Fi/Et value CO2, O2, N2O, anesthetic gas (ENF, ISO, whichever is greater
SEV, HAL, DES) TVi Adu 150~2000ml, Ped 15~300ml
Waveform Up to 4 gas concentration waveforms accuracy: ±15ml/±10%xreading,
displayed simultaneously whichever is greater
Diagnostic Atmospheric pressure TVe Adu 150~2000ml, Ped 15~3000ml
parameter accuracy: ±10ml/±10%xreading,
Gas analyzer whichever is greater
ISA sensor NDIR-type gas analyzer, with 2~9 PIF, PEF Adu 0.5~30LPM Ped 1.5~120LPM
channels, measuring range: 4~10µm accuracy: ±1LMP/±10%xreading,
Preheat time: ISA CO2: <10s whichever is greater
ISA OR+/AX+: <20s MVi, MVe Adu 2~20l/min Ped 0.5~5l/min
Gas accuracy: ±1l/m/±10%xreading,
Rising time CO2: ≤250ms whichever is greater
N2O: ≤350ms RR Adu 4~35bpm Ped 4~50bpm
Anesthetic gases: ≤350ms accuracy: ±1bpm
O2: ≤450ms I:E 1:4.5~2:1
System total <3s (2m sampling line) Coml Adu 4~100 m/cmH2O
response time Ped 1~100 ml/cmH2O
RESP detection Adaptive threshold; minimum 1 vol% FEV1.0 0~100%
CO2 concentration change RSBI 0~200 bpm/L
RESP frequency 0~150 times/min WOB 0~1 J/L
Anesthetic gas Main AG threshold (ISA OR+/AX+): Raw 0~40 cmH2O/L/s
threshold 0.15 vol% Alarm PIP:
 -20~100 cmH2O, resolution: 1cmH2O Early Warning Modified early warning score (MEWS)
PEEP: Score (EWS) Total score system
-20~200 cmH2O, resolution: 1cmH2O Glasgow Coma For adult and pediatric
MVe: Scale (GCS) eye opening, verbal response, motor
Adu 2~20 L/min Ped 0.5~5 L/min, response
resolution: 0.5L/min ECG 24H the current patient’s ECG activity
Respiratory Loops PV loop(pressure-volume) Summary statistics for the last 24 hours
FV loop(flow-volume) Waveform Freezing (only for external display)
PF loop(pressure-flow) Timer
Apnea Time Adu 15~60s Ped/Neo 15~40s External Display (Mirror-screen display, Independent-screen
resolution:5s display)
Rainbow SpO2 (only for Portable Plug-in Box) Environmental requirements
SpO2 Range: 40~100% Temperature Operating: 0-40℃
Accuracy: Storage: -20-70℃
Ped/Adu: ±2% (70~100%) Humidity Operating: 5~95%
Neo: ±3% (70~100%) Storage: 5~93%
SpCO Range: 0~42% Barometric Operating: 57.0~107.4mmHg
Accuracy: Storage: 5~93%
Adu/Ped/Neo: ±5% (1~40%) External Power Supply
Resolution: 0.1% Main Unit 100-240V~, 50/60Hz; 1.0~0.5A
SpMet Range: 0~18% Docking Station 100-240V~, 50/60Hz; 1.0~0.5A
Accuracy: ±1.5% (0~15%) Adapter
Resolution: 0.1% & Main Unit 15V DC; 2A
SpHb Range: 0~25g/dL Battery
Accuracy: Type Rechargeable Lithium-ion battery
Ped/Adu: ±2g/dL (8~17g/dL) Capacity DC 10.8V/3350mAh
Resolution: 0.1g/dL Run time Not less than 10 hours
PVI Range: 0~100% (New fully charged battery, room
SPOC Range: 0~35ml/dl temperature 25℃±5℃, simulated
Resolution: 1ml/dl SpO2, 3/5 lead ECG, NIBP starts
Perfusion Index Range: 0~20% measurement every 15 min, connects
SpO2 probe, connects 5 lead ECG
Apnea wake-up function (only for Portable Plug-in Box)
cable, screen brightness of level 1.)
Stimulus mode The beater vibrates
Charging time In power-off state: 3 hours
Stimulus intensity 15000±800 rpm
(to 90%) In power-on state: 4.5 hours
Stimulus cycle 5s (3s on, 2s off)
Date storage
Respond time 0-20s
Alarm Event 2000 groups
Special Functions NIBP 2000 groups
Clinical Assistant Assessment (CAA) Trend Graph 160 hours
(only for external display) Trend Table 160 hours
SpesisSight Sepsis screening: Full Disclosure 48 hours (Holographic waveforms)
qSOFA score, SOFA score ARR Event 48 hours
Treatment tracking tools: Alarm
SSC Bundle Therapy, Supportive Meet standard of IEC60601-1-8.
Therapy Audible Indicator 3 different alarm tones
Visible Indicator Red/Yellow/Cyan light Multi-function connector
Prompt message (For Defib Sync and Analog Output)
Volume Level 1~10 USB connectors 4
Wi-Fi communications (For external printer, keyboard,
Protocol IEEE 802.11a/b/g/n mouse, barcode reader, etc.)
Modulation Mode DSSS and OFDM Print
Operating IEEE 802.11b/g/n (2.4G): The monitor can output patient reports through USB cable
Frequency ETSI/FCC/KC: 2.4~2.483 GHz connected printer or networked printer.
MIC: 2.4~2.495 GHz Paper A4
IEEE 802.11a/n (5G): Resolution 300dpi
ETSI: 5.15~5.35 GHz, 5.47~5.725 GHz Reliability
FCC: 5.15~5.35 GHz, 5.47~5.725 GHz, Type of Protection Class I
5.725~5.82 GHz, Degree of ECG/RESP/TEMP/SpO2/IBP/NIBP/C.O.:
MIC: 5.15~5.35 GHz, 5.47~5.725 GHz Protection CF
KC: 5.15~5.35 GHz, 5.47~5.725 GHz, CO2/BIS/AG/RM/O2: BF
5.725~5.82 GHz Ingress protection Main Unit: IP44
Output Power < 20dBm (CE requirement: detection Portable Plug-in Box: IP11
mode- RMS) Docking Station: IP11
< 30dBm (FCC requirement, detection SP02: IPX2
mode- peak power) BIS: IPX4
Interfacing Safety standards IEC60601-1, IEC 60601-2-27, IEC
Main Unit 80601-2-30, IEC 60601-2-34, ISO
DC power connector (15V) 80601-2-25, ISO 80601-2-56, ISO
Multi-function connector 80601-2-61, IEC 60601-2-26, IEC
(For connecting the Host, Portable 80601-2-49, IEC 60601-1-8, IEC 60601-
Plug-in Box or Docking Station; Defib 1-2
Sync; Analog Output) Out-of-hospital EN1789: Medical vehicles and their
Portable Plug-in Box transshipment equipment-Road ambulances
Multi-function connector standards Free fall test: EN60068-2-332
(For connecting the docking station) (height: 1.2m)
Plug-in slot 1 Impact test: IEC/EN60068-2-27

Docking Station (maximum peak acceleration 100g)

Random vibration: IEC/EN60068-2-64
AC power connector
(RMS: 5g)
Equipotential Grounding Terminal
Sinusoidal vibration: IEC/EN60068-2-6
VGA connector
(maximum amplitude: 2g)
(For external display)
Network connector (RJ45) Collision test: IEC/EN60068-2-29
(peak acceleration 15g, 1000 times)

*Notice: Specifications subject to changes without prior notice. All rights reserved by Comen