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Specifications: S8

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

2022V 1.8
Defibrillator/Monitor
S8

Standard Configuration Operation Environment


Manual defibrillation, AED, 5-lead ECG, RESP, Thermal Temperature: 0~45℃
Recorder Atmospheric pressure: 570hpa-1060hpa
Application Humidity: 10%~95%, non-condensation
For use in the ICU, surgical rooms, emergency area or during Power
emergency life threatening situations. For adults and Power requirement: 100-240V~, 50/60Hz
pediatrics Battery type: Rechargeable Lithium-ion battery
Optional Battery capacity: 5000mAh,dc.14.4V;
12-lead ECG, NIBP, TEMP, PR, EtCO2, IBP, SPO2,Pacing 7500mAh, d.c.14.8V
Respironics LoFlo CO2 Battery number: Max 2
Respironics CapnoTrak CO2 Battery recharging Less than 1.5 hours to 80% and
Masimo Nomoline ISA sidesdream Time: less than 2.5 hours to 100% with
EtCO2 Comen sidestream equipment power off(500mAh)
Respironics CAPNOSTAT5 mainstream Battery backup:
Masimo IRMA CO2 mainstream With 2 new fully charged batteries.
Comen mainstream 7500mAh Monitoring Mode: Up to 12 hours;
Specific parameters refer to the CO2 module parameter Defib Mode: Up to 420 discharges
table (360J charge at intervals of
Safety Standards 1minute without recording);
ISO 13485:2016 approved, CE marking according to Pacing Mode: Up to 9 hours (50 Ω
MDD93/42/EEC, IEC 60601-1 conformity load impedance, pacing rate:
Physical Characteristics 80bpm, Pacing output: 60mA,
Size: 323mm×277mm×338mm without recording)
Weight: Standard Device: 6.55 kg (without 5000mAh Monitoring Mode: Up to 8 hours;
battery) Defib Mode: Up to 260 discharges
Standard Device + Paddles: 7.2 kg (360J charge at intervals of
(without battery) 1minute without recording);
Standard Device + Paddles: 7.9kg Pacing Mode: Up to 6 hours (50 Ω
(with 1 battery) load impedance, pacing rate:
Screen Size: 8.4” TFT screen 80bpm, Pacing output: 60mA,
Resolution 800 × 600 without recording)
Waveforms: 5 waveforms
6 waveforms for 12-lead ECG
Ingress Protection: IP44 (without external power)
Brightness: Manual from 1 to 100
Indicators Defibrillation
Two alarm indicators Operating mode: Manual Mode, AED Mode,
Power indicator Synchronous defibrillation
Battery indicator Waveform: Biphasic truncated exponential
Maintain indicator waveform, with impedance
Error indicator compensation
QRS beep and alarm sound Defibrillation pathway: External defibrillation
Operating key sound Electrode type: External defibrillation paddles,
Interfacing multifunctional electrode (adult
USB interface and pediatric)
RJ45 interface External defibrillation Supports charging, discharging and
AC power input electrode paddles: energy selection; Charging
VGA interface completion indicator
Multi-functional connector Charge Time:
Data storage With new, fully charged battery.
Alarm Event: 200 groups DC Charge Time Less than 3 seconds to 200 Joules.
Patient profiles: 100 groups (Battery Power): Less than 7 seconds to 360 Joules.
Patient Events 1000 groups AC Charge Time Less than 4 seconds to 200 Joules.
Wave Review: 16.6 hours (Battery power): Less than 8 seconds to 360 Joules.
NIBP Review: 2000 groups Energy accuracy: ±1.5J or ±10% of setting,
Trend Graph: 160 hours whichever is greater, at 50 Ω
Trend Table: 160 hours impedance
ECG report: 500 cases of 12-lead ECG diagnosis ±2J or 15% of setting, whichever is
report (Up to 5 case reports per greater, at 25 Ω, 75 Ω, 100 Ω, 125
patient) Ω, 150 Ω, 175 Ω impedance
Voice recording: Max 240 min in total; Patient Impedance 20~300 Ω for external
(Up to 60 min for each patient) Range: defibrillation
Marked events Available Defibrillation proof: Type CF: ECG, RESP, SpO2, NIBP,
Power-off storage: Yes IBP, TEMP, PR;
Alarm: User-adjustable High and Low 3- Type BF: CO2
level Limits; Manual Mode
Prioritized audible and visual External defibrillators: 1J~360J, 25 types
alarm (1/2/3/4/5/6/7/8/9/10/15/20/30/
Network: Connected to Central Monitoring 50/70/100/120/150/170/200/220/
System by hardwire/wireless 250/270/300/360J)
Recorder Synchronous Energy transfer begins within
Type: Built-in; Thermal array Cardioversion: 60ms of the R wave
Channel: 4 channel waveforms Energy transfer begins within
Real-time recording: 3s, 5s, 8s, 16s, 32s, Continual 25ms of the External Sync signal
Speed: 25mm/s, 50mm/s
Record width: 80mm
Resolution: 8dot/mm (Horizontal and vertical)
Background grid: Configurable
External printer: Yes
AED High limit: (low limit+2bpm) ~
Output Energy: Adjustable:100-360J 300bpm
Number of electric Adjustable: once, twice, 3 times Low limit: 15bpm~ (high limit-
shocks: 2bpm)
Maximum time required for cardiac rhythm analysis to be Pediatric:
ready for discharge: High limit:(low limit+2bpm) ~
Battery power supply: 18s 300bpm
AC power supply: 21s Low limit: 15bpm~(high limit-
Arrhythmia types: VF & VT 2bpm)
Resolution: 1 bpm
Noninvasive Pacing Accuracy: ±1% or ±1bpm (whichever is
Waveform: Monophasic square wave pulse greater)
Pulse Width: 20 ms or 40ms
Accuracy: ±5% Bandwidth: Monitoring: 0.5~40Hz (-
Pacing Mode: On-demand or fixed 3.0dB~+0.4dB)
Pacing frequency: 30 ppm to 210 ppm Diagnosis: 0.05~150Hz (-
Accuracy: ±1ppm or ±1.5% (whichever is 3.0dB~+0.4dB)
greater) Surgery: 1~20Hz (-3.0dB~+0.4dB)
Pacing output: 0 mA to 200 mA ST: 0.05~40Hz(-3.0dB~+0.4dB)
Accuracy: ±5% or ±5mA, whichever is greater CMRR: Monitoring: >105dB
Speed-down pacing: Pacing pulse frequency reduced to Diagnosis: >90dB
25% of original value. Surgery: >105dB
Monitoring ST: >105dB
ECG (leads) Input Impedance: ≥5MΩ
Lead Type: 3 leads ECG, 5 leads ECG, 12 leads Input signal range: ±8mV
ECG, AUTO HR trigger threshold 200μV
Lead selection: 12-Lead: I; II; III; aVR; aVL;aVF; Lead off detection Measuring electrode: <0.1μV
V1~V6 current:
5-lead: I; II; III; aVR; aVL; aVF; V Driving electrode: <1μV
3-lead: I; II; III Pacemaker pulse Manual selection when the
Multi-lead suppression switch: pacemaker is turned on
synchronization Available Analog output: Magnification: 1:1000;
analysis: Accuracy: ±5%
ECG wave gain: Auto, 1.25 mm/mV (×0.125), Bandwidth: 0.5Hz~40Hz
2.5 mm/mV (×0.25), 5 mm/mV Delay: ≤35ms
(×0.5), 10 mm/mV (×1), ST Detection: -2.0mV~+2.0mV
20 mm/mV (×2), 40 mm/mV (×4) Resolution: 0.01mV
Accuracy: Less than ±5% Accuracy: -0.8mV ~ +0.8mV: ±0.02mV or
Sweep speed: 6.25 mm/s, 12.5 mm/s, 25 mm/s, ±10%; Others: Unspecified
50 mm/s ST analysis review 20 groups
Accuracy: Less than ±10% System noise: Less than 25μV
Heart Rate: Adult: 15~300bpm Calibration voltage 1 mV; Accuracy: ±5%
Pediatric:15~350bpm Arrhythmia Analysis: 26 Types
Accuracy: ±1bpm Pacemaker detection: Detectable
Alarm limit range Adult:
ECG (paddles) MASIMO SpO2
Lead Type: Single lead ECG Monitoring & alarm
Heart Rate Adult: 15~300bpm range: 1~100%
measurement & alarm Pediatric:15~350bpm Monitoring
range: Resolution: 1%
Resolution: 1 bpm Monitoring Accuracy: ±2% (70~100%, Ped/Adu, non-
Accuracy: ±1% or ±1bpm (whichever is motion)
greater) ±3% (70~100%, non-motion);
Bandwidth: Defib: 1~20Hz 1~69% unspecified
CMRR: Defib: >105dB Alarm range: 1~100%
Input Impedance: ≥5MΩ PR Measurement
Input signal range: ±8mV range: 25~240bpm
HR trigger value 200μV PR Resolution: 1bpm
Arrhythmia Analysis: 5 Types, ASY, VF, VT, PNC, and PNP PR Accuracy: ±3% (non-motion)
±5% (motion);
RESP Alarm range: 20~350bpm
Method: Thoracic Impedance Method PI value range: 0.02~20%
RR measurement Adult: 0~120bpm
PI Resolution: 0.01% (0.02%~9.99%)
range: Pediatric: 0 ~150bpm
0.1% (10.0%~20.0%)
Accuracy: 7~150bpm: ±2bpm or ±2%
PI Accuracy: Unspecified
(whichever is greater)
SIQ: Available
0~6bpm: unspecified
Apnea Alarm: Adult: 10s~60s Ped: 10s~40s
COMEN Sure-Oxi™ SpO2
Accuracy: ±5s
Monitoring & alarm
Alarm: Audible and visual alarms;
range: 0~100%
Alarm events reviewable
Monitoring
Resolution: 1%
Nellcor SpO2
Monitoring Accuracy: ±2% (70~100%, Ped/Adu, non-
Measurement range: 0~100%
motion)
Resolution: 1%
0~69% unspecified
Accuracy: ±2% (70~100%, Adu/Ped, non-
PR Measurement
motion)
range: 20~254bpm
1~69% unspecified
PR Resolution: 1bpm
Alarm range: 20~100%
PR Accuracy: ±2bpm
PR Measurement
Alarm range: 20~350bpm
Range: 20~300bpm
PI value range: 0.05~20%
PR Resolution: 1bpm
PI Resolution: 0.01% (0.05%~9.99%)
PR Accuracy: ±3bpm (20~250bpm)
0.1% (10.0%~20.0%)
Unspecified (251~300bpm)
PI Accuracy: Unspecified
Alarm range: 20~350bpm
SIQ: Available
Respironics EtCO2 (Sidestream) NIBP
Measurement range: 0~150mmHg, 0to 25% (at Method Automatic oscillometry
760mmHg) Work mode: Manual/Automatic/Continuous
Accuracy: ± 2 mmHg (0 – 40 mmHg)
Interval Time: Adjustable
± 5% of reading (41 – 70 mmHg)
1/2/2.5/3/4/5/10/15/30/60/90/12
± 8% of reading (71 –100 mmHg)
0/180/240/480/720 min
±10% of reading (101~150 mmHg)
Maximum Adu/Ped: 120s
Resolution: 1mmHg
measurement cycle
awRR Range: 0~150rpm
Measurement Unit: mmHg / kPa selectable
awRR Accuracy: ±1rpm
Pressure types: Systolic, Diastolic, Mean
Response time: <240msec (10% to 90%)
Delay time: <2s Range of systolic Adult Mode: 5.3~36kPa
pressure: (40~270mmHg)
IBP Pediatric Mode: 5.3~26.7kPa
Channel: 2 Channels (40~200mmHg)
Measured Pressure: ART, PA, CVP, RAP, LAP, ICP, LV, Range of diastolic Adult Mode:1.3~28.7kPa
AO, UAP, BAP, FAP, UVP, IAP, P1, pressure: (10~215mmHg)
P2, P3, P4 Pediatric Mode: 1.3~20kPa
Measurement Unit: mmHg/ kPa/ cmH2O selectable (10~150mmHg)
Measurement range: ART: 0~300mmHg Range of mean Adult Mode: 2.7~31.3kPa
PA: -6~120 mmHg pressure: (20~235mmHg)
CVP: -10~40mmHg Pediatric Mode: 2.7~22kPa
RAP: -10~40mmHg (20~165mmHg)
LAP: -10~40mmHg Over pressure Adult: 297mmHg
ICP: -10~40mmHg protection: Pediatric: 240mmHg
LV: 0~300mmHg Tolerance: ±3mmHg
AO: 0~300mmHg Accuracy: Maximum average deviation:
UAP: 0~300mmHg Resolution: ±5mmHgO(±0.667Kp)
BAP: 0~300mmHg Maximum standard deviation:
FAP: 0~300mmHg ±8mmHg(±1.607kPa)
UVP: -10~ 40mmHg Alarm limit: Same as the range of
IAP: -10~40mmHg measurement
P1, P2,P3,P4: -50~300mmHg PR from NIBP: 40bpm~240bpm
Accuracy: ±2% or ±1mmHg (whichever is Resolution: 1bpm
greater) Accuracy: ±3% or ±3bpm, whichever is
Resolution: 0.1kPa or 1mmHg greater
(-50mmHg~+300mmHg)
Alarm Range: -50mmHg~+300mmHg
PR from IBP: 20bpm~350bpm
Resolution:
Accuracy: ±1% or ±1bpm, whichever is
greater
PPV/SPV Available
measurement:
PAWP measurement: Available
Temperature (Dual Channel) MSB Electrodes for 1bpm
Measurement & alarm Adult(pack)
range: 0~50°C Recorder Paper
TEMP sensor: Standard configuration-skin TEMP Defibrillation
sensor Extension Cable
Resolution: 0.1°C Electrode Extension
Accuracy: ±0.1°C (exclusive of error of Wire (For stress
sensor) testing)
Channel type: T1, T2, TD (Temperature Conductive Gel
Difference) Operation guide
User Manual
Cart Power Cord
COMEN Universal Cart
Warranty
Accessories COMEN provides the following warranties.
12Pin 5Lead Clip Comprehensive Warranty: 2 years
Connector ECG Spare parts after Warranty
5 years
Cable/Lead period:
replaceable Anti- Annual maintenance.
Defibrillation/IEC

*Notice: Specifications subject to change without prior


notice. All rights reserved by COMEN

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