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