Digitally signed by Antonova Anna

Date: 2021.07.05 14:03:13 EEST

Reason: MoldSign Signature
Location: Moldova

Specification: C86

SHENZHEN COMEN MEDICAL INSTRUMENT CO.,LTD

No.2 of FIYATA Timepiece Building, Nanhuan Avenue, Gongming
sub-district, Guangming New District, Shenzhen, P.R. China
Tel: +86-755-26408879
Fax: +86-755-26431232
Email: infoatszcomen.com
Web: en.comen.com

2020 V 1.3
Patient Monitor
C86

Standard Configuration: QRS beep and alarm sound

5-lead ECG, RESP, Temp (Single Channel), COMEN SpO2, Operating key sound
NIBP, HR
Optional Configuration: Interface:
Dual-IBP, EtCO2, AG, ICG, C.O., BIS, Nellcor/Masimo SpO2, Parameter cable interface
3/12-lead ECG, Thermal Recorder, Dual-Temp, Suntech NIBP, AC power input socket
Trolley, Wall mount, Ground wire Two USB port
Safety Standards: RJ45 port
IEC 60601-1 IEC 60601-1-8 IEC 60601-2-27 EN 1060-3 IEC Optional Multi-functional interface
80601-2-30 IEC60601-2-34 IEC60601-2-49 ISO 80601-2-56 ISO VGA output
80601-2-61 Data storage
Physical Characteristics: Alarm Event Recall: 200 groups
Product Size: 344mm*291mm*165mm Wave Recall: 6 hours (8 waves)
Weight: 4.1kg NIBP Recall: 2000 groups
Display: 15” color TFT touch screen Trend Graph: 160 hours
Resolution: 1024*768 Trend Table: 160 hours
IP grade IPX1 Power-off Yes
Trace: 8 waveforms storage：
Operation Environment: Alarm: User-adjustable High and Low 3-level
Working Limits;
Temperature 5-40°C Prioritized audible and visual alarm
Humidity: ≤93% Network: Connected to Central Monitoring
Power Supply 100-240V~, 50/60Hz±1Hz System by hardwire/wireless
Battery Type: Rechargeable Lithium-ion battery Recorder:
Battery Capacity: 2200mAh (optional: 4400mAh) Type: Built-in; Thermal array
Battery Recharging Channel: 3 channel waveforms
Time: Maximum 5.5 hours for charging; Speed: 25mm/s,50mm/s
Battery backup: 2 hours for continuous working Record width: 50mm
Indicator: Real-time record
One alarm indicator time 8s, 16s, 32s or continual
Power indicator Alarm record Yes
Battery indicator Respiration:
Method: RA-LL Impedance Method ST SEGMENT
RR measurement detection: -2.0mV~+2.0mV (Automatic)
Range Adult: 0-120rpm Arrhythmia
Pediatric/Neonate:0-150rpm Analysis: 26 types
Accuracy: 7~150rpm: ±2rpm or 2%, whichever is Pacemaker
greater detection: Detectable
0-6rpm: unspecified Alarm: Yes, audible and visual alarm, alarm
Resolution: ±1 rpm events reviewable
RESP Apnea 10s-60s (Adu); 10s-40s (Ped/Neo) 12 lead ECG
Alarm: Audible and visual alarm; alarm events Analysis: Yes
reviewable NIBP:
Sweep Speed: 6.25,12.5,25mm/s Method Automatic oscillation
Gain Selection: X0.25, X0.5, X1, X2, X4 Work mode: Manual / Automatic/Continual (5min,
ECG: not applicable to neonates)
TM
Lead Type： CardioTec 5-leads ECG Analysis, 12- Measurement time: Adjustable(1-480min)
Lead and 3-leads electable Maximum
Lead selection 12-Lead I; II; III; aVR; aVL; aVF; V1-V6. measurement time Adu/Ped: 120s; Neo: 85s
5-lead: I; II; III; aVR; aVL; aVF; V Measurement Unit: mmHg / kpa selectable
3-lead: I; II; III Measurement
Waveform 5-lead: 2 -channel types: Systolic, Diastolic, Mean
3-lead: 1 -channel Range of systolic
Gain Selection: X0.125, X0.25, X0.5, X1, X2, X4, auto pressure: Adult Mode: 40-270mmHg
error＜±5% Pediatric Mode: 40-200mmHg
Sweep Speed: 6.25,12.5, 25, 50mm/s, error≤±10% Neonate Mode: 40-135mmHg
Resp, lead Range of diastolic
disconnection pressure: Adult Mode: 10-215mmHg
detection and AC waveform: Pediatric Mode: 10-150mmHg
active noise Current :<0.1µA; Neonate Mode: 10-100mmHg
control: Frequency 64kHz, ±10% Range of mean
CMRR ≥105 dB pressure: Adult Mode:20-235mmHg
Heart Rate Pediatric Mode:20-165mmHg
measurement Neonate Mode 20-110mmHg
Range: Adult: 15~300bpm Static pressure
Pediatric/Neonate:15~350bpm range and accuracy:
Accuracy: ±1% or ±1bpm (whichever is greater) 0~300mmHg(0kPa~40.0kPa)
Protection: Withstand 4000VAC/50Hz voltage in ±3mmHg(±0.4kPa)
isolation, Again electrosurgical Over-pressure
interference and defibrillation protection: Adult Mode: 297mmHg
Accuracy: ±1% or ±1bpm (whichever is greater) Pediatric Mode: 240mmHg
Band width: Monitoring Mode: 0.5-40Hz Neonate Mode: 147mmHg
Diagnosis mode: 0.05-150Hz Accuracy: ±3mmHg
Surgery mode:1-20Hz Initial pressure
ST mode: 0.05-40Hz range(mmHg): Adult: 80~240；Pediatric: 80~200；
Neonate:60~120
Alarm: Systolic, Diastolic, Mean ±3% (70-100%, Neo, non-motion)
PR from NIBP: Measurement & alarm range: 40- Unspecified (1-69%)
240bpm Data averaging and
Resolution: 1bpm other signal
Accuracy: ±3bpm or ±3%, whichever is processing time: 2s
greater Data refresh rate: 8s
Nellcor SpO2: PR Measurement
Measurement Range: 20--254bpm
Range 0-100% Resolution: 1bpm
Alarm Range 20-100% Accuracy: ±2bpm
Resolution: 1% Alarm range: 20~254bpm
Accuracy: ±2% (70-100%, Adu/Ped, non-motion) Perfusion index: 0.05%~20%
±3% (70-100%, Neo, non-motion) Resolution: 0.01% (within
1-69% unspecified 0.05%~9.99% range) or 0.1% (within
Alarm Range: 20-100% 10.0%~20.0% range)
PR Measurement Temperature (Dual Channel)
Range: 20-300bpm Range: 0-50°C
Resolution: 1bpm TEMP sensor: Skin/rectal TEMP sensor
Accuracy: ±3bpm (20-250bpm); Resolution: 0.1°C
Unspecified (251-300bpm) Accuracy: ±0.1°C (exclusive of error of sensor)
Alarm Range: 20~300bpm Channel: T1, T2, TD (Temperature Difference)
Masimo SpO2: EtCO2
Measurement & Unit: mmHg, kPa
alarm Range 1~100% Measurement
Resolution: 1% range: 0mmHg~150mmHg
Accuracy: ±2% (70-100%, Adu/Ped, non-motion) Resolution 1mmHg or 0.1kPa or 0.1%
±3% (70-100%, Neo, non-motion) Accuracy 0mmHg ~40mmHg should be±2mmHg;
1-69% unspecified 41mmHg ~70mmHg should
Alarm range 1~100% be±5%×reading;
PR Measurement 71mmHg ~100mmHg should
Range 25~240bpm be±8%×reading;
Resolution: 1bpm 101mmHg~150mmHg should
Accuracy: ±3bpm (non-motion) be±10%×reading
±5bpm (motion); Oxygen
Alarm range: 25~240bpm compensation 0～100 mmHg
Perfusion index: 0.02~20% Equilibrium gas Helium, room air, nitrous oxide
Resolution: 0.01% (within IBP
0.02%~9.99% range) or 0.1% (within Channel: 2 Channels
10.0%~20.0% range) Measured Pressure: ART, PA, CVP, RAP, LAP, ICP, LV, AO,
COMEN SpO2: UAP, BAP, FAP, UVP, IAP, P1, P2, P3, P4
Measurement Measurement Unit: mmHg/ kPa selectable
& alarm Range 0~100% Measurement
Resolution: 1% Range: ART: 0~300mmHg
Accuracy: ±2% (70~100%, Adu/Ped, non-motion) PA: -6~120 mmHg
 CVP: -10~40mmHg Data output: Fi and Et values
RAP: -10~40mmHg AG resolution: CO2: 1mmHg
LAP: -10~40mmHg awRR: 1rpm
ICP: -10~40mmHg Accuracy: For all measured values complies with
LV: 0~300mmHg EN ISO 21647:2004 and EN 864:1996
AO: 0~300mmHg Alarm: EtCO2: 0mmHg~190mmHg
UAP: 0~300mmHg Fi CO2: 0mmHg~190mmHg
BAP: 0~300mmHg AwRR: 2mmHg~150mmHg
FAP: 0~300mmHg EtO2: 18% ~ 100%
UVP: -10~ 40mmHg FiO2: 18% ~ 100%
IAP: -10~40mmHg EtN2O: 0% ~ 100%
P1, P2, P3, P4: -50~300mmHg FiN2O: 0% ~ 82%
Accuracy: ±2% or ±1mmHg, whichever is greater EtHal/EtEnf/EtIso/EtSev/EtDes: 0% ~
Resolution: 0.1kPa or 1mmHg 25%
(-50mmHg~300mmHg) FiHal/FiEnf/FiIso/FiSev/FiDes: 0% ~
Alarm Range: -50mmHg~300mmHg 25%
Pressure sensor: sensitivity: 5 V/V/mmHg Others: Up to 4 waveforms displayed
Impedance range: 300~3000Ω MAC value displayed
PR from IBP: Measurement & alarm range: ISATM (AG) Sidestream Gas Analyzer
20bpm~350bpm Method: Infrared gas measurement
Resolution: 1bpm No Breaths
Accuracy: ±1bpm or ±1%, whichever is Timeout range Adult: 10s, 15s, 20s, 25s, 30s, 35s,
greater 40s ,45s, 50s, 55s or 1min;
Pediatric and neonate: 20s, 25s, 30s,
AG 35s or 40s
AG (complies with ISO 80601-2-55) Accuracy: ±5s
Method: Infrared Radiation Absorption No Breath Alarm
Characteristics Delay: 10s, 15s, 20s, 25s, 30s, 35s, 40s, 45s,
AG preheating time 50s, 55s, 1min or Off
<20s Working
Gas sorts: CO2, N2O, DES, ISO, ENF, SEV, HAL, O2 conditions: ISA AX+: 0~50°C (32~122°F); ISA OR+:
(optional paramagnetic sensor) 5~50°C (41~122°F)
Measurement Storage conditions -40~70°C (-40~158°F)
range: CO2: 0~15%: ±(0.2kPa+reading×2%), RH <4kPa H2O (non-condensing) 95% RH,
15~25%: unspecified 30°C
N2O: 0~100 %: ±(2kPa+reading×2%) Barometric
HAL, ISO, ENF: 0~8%: ± pressure 52.5~120kPa (4572m)
(0.15%+reading×5%); 8~25vol%: Water treatment Sampling tube: patented dehydration
unspecified tube
SEV: 0~10%: ± (0.15%+reading×5%); Data output: Fi and Et values
10~25vol %: unspecified Waveform: Display up to 4 gas concentration
DES: 0~22%: ± (0.15%+reading×5%); waveforms at a time
22~25%: unspecified Diagnostic
O2: 0-100%: ± (1%+reading×2%) parameter: Barometric pressure
ISA sensor: 2~9-channel NDIR gas analyzer Step: 0.1°C
(measurement range: 4~10µm) Impedance Cardiography (ICG)
Compensation: CO2 broadening effect
Calibration No calibration is required. The Monitor Method: Indirect measurement by the
will auto perform zeroing when impedance cardiogram
powered on and perform auto zeroing Measurement
every 24h (ISACO2) or 8h (ISA range: SV: 5~250 ml/ beat
AX+/OR+) subsequently. HR: 40~250 bpm
Preheating time ISA CO2: <10s; ISA OR+/AX+: < 20s C.O.: 1.4~15 L/min
Rise time CO2: ≤250ms; N2O: ≤ 350ms; Accuracy: HR: ±2bpm
anesthetic gases: ≤ 350ms; O2: ≤ C.O.: Unspecified
450ms SV: unspecified
Overall system Alarm range: C.I.:0~15.0L/min/m2
response time <3s (2m sampling tube) TFC:10~150KΩ
Respiration
Alarm Deviation C.I.: ±0.1L/min/m2
detection Self-adaptive threshold (minimum CO2
TFC: ±1k Ω
concentration change: 1 vol%)
RR 0~150 breaths/min BIS
Anesthetic gas Measurement
threshold Threshold of main anesthetic gases range: BIS: 0~100; Accuracy: 1%
(ISA OR+/AX+): 0.15 vol%. The SQI: 0~100%; Accuracy: 1%
concentration of any identified EMG: 0~100dB; Accuracy: 1%
anesthetic gas will be reported, even if ESR: 0~100%; Accuracy: 1%
it is lower than 0.15 vol% Resolution: 1
Cardiac Output (C.O.) Alarm range: BIS: 0~99
Method: Thermodilution Wall Mounting
Range: C.O.: 0.1~20L/min Net weight: 3.1kg
BT: 25~43°C Bracket: 275*150*165mm
IT: 0~25°C Length 330mm
Resolution: C.O.: 0.01L/min (Support Arm)
BT, IT: 0.1°C Max. Slip 140mm
Accuracy: C.O.: ±5% or ±0.1 L/min，whichever is Rotation 180°
greater
BT, IT: ±0.1°C (no sensor) *Notice: Specifications subject to changes without
Alarm Range: BT Hi limit: (LO limit +0.4)-43°C prior notice. All rights reserved by COMEN
BT Lo limit:25.0～(Hi limit-0.4) °C