The document provides specifications for the S8 defibrillator/monitor made by Shenzhen Comen Medical Instruments Co., including its standard configuration, optional modules, safety standards, physical characteristics, and details on its defibrillation, monitoring, and pacing functions. Key features include manual and AED defibrillation modes, 5-lead ECG, rechargeable lithium-ion batteries, a 8.4" color screen, and storage for patient data, events, and waveforms.
The document provides specifications for the S8 defibrillator/monitor made by Shenzhen Comen Medical Instruments Co., including its standard configuration, optional modules, safety standards, physical characteristics, and details on its defibrillation, monitoring, and pacing functions. Key features include manual and AED defibrillation modes, 5-lead ECG, rechargeable lithium-ion batteries, a 8.4" color screen, and storage for patient data, events, and waveforms.
The document provides specifications for the S8 defibrillator/monitor made by Shenzhen Comen Medical Instruments Co., including its standard configuration, optional modules, safety standards, physical characteristics, and details on its defibrillation, monitoring, and pacing functions. Key features include manual and AED defibrillation modes, 5-lead ECG, rechargeable lithium-ion batteries, a 8.4" color screen, and storage for patient data, events, and waveforms.
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: 7500mAh,dc.14.4V; 12-lead ECG, NIBP, TEMP, PR, EtCO2, IBP, SPO2,Pacing 5000mAh, 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(5000mAh) Respironics CAPNOSTAT5 mainstream S8_Specifications_V1.9_2022.05.1 Masimo IRMA CO2 mainstream 3 0mAh) Comen mainstream Battery backup: Specific parameters refer to the CO2 module parameter With 2 new fully charged batteries. table 7500mAh Monitoring Mode: Up to 12 hours; Safety Standards Defib Mode: Up to 420 discharges ISO 13485:2016 approved, CE marking according to (360J charge at intervals of MDD93/42/EEC, IEC 60601-1 conformity Physical Characteristics 1minute without recording); Size: 323mm×277mm×338mm Pacing Mode: Up to 9 hours (50 Ω Weight: Standard Device: 6.55 kg (without load impedance, pacing rate: battery) 80bpm, Pacing output: 60mA, Standard Device + Paddles: 7.2 kg (without battery) without recording) Standard Device + Paddles: 7.9kg (with 1 battery) 5000mAh Monitoring Mode: Up to 8 hours; Screen Size: 8.4” TFT screen Defib Mode: Up to 260 discharges Resolution 800 × 600 (360J charge at intervals of Waveforms: 5 waveforms 1minute without recording); 6 waveforms for 12-lead ECG Pacing Mode: Up to 6 hours (50 Ω Ingress Protection: IP44 (without external power) load impedance, pacing rate: Brightness: Manual from 1 to 100 80bpm, Pacing output: 60mA, without recording) 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 f 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: Not supported 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