FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use

  • Audited Supplier
  • 7 yrs

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Product Highlights

  • Comprehensive Monitoring: Supports ECG, RESP, SpO2, PR, NIBP, dual-channel TEMP, and optional IBP/CO2.
  • FDA & CE Certified: FDA-approved with CE and ISO13485 certifications for home and hospital use.
  • Advanced ECG Analysis: Features arrhythmia, ST-segment analysis, and pacemaker detection with 5-lead options.
  • Flexible NIBP Modes: Supports Manual, AUTO, and STAT modes with intervals from 1 to 960 minutes.
  • Safety & Reliability: Class I, type CF defibrillation-proof applied part with audible/visual alarms.
  • Data Storage & Output: Includes trend data storage, output capabilities, and alarm event marking.
  • Versatile Power Supply: Operates on 100-240V~, 50/60Hz, suitable for global hospital and home environments.

Product Images of FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use

FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use pictures & photos
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use pictures & photos
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use pictures & photos
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use pictures & photos
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use pictures & photos
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use pictures & photos
FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
  • FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
  • FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
    FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
  • FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
    FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
  • FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
    FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
  • FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
    FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
  • FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
    FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
  • FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use
    FDA-Approved Portable ECG Patient Monitor for Home and Hospital Use

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Product Description

MODEL:CMS8000 
Functions
Standard parameters: ECG, RESP, SpO2, PR, NIBP, dual-channel TEMP
1)ECG Heart rate(HR)
ECG waveform
Arrhythmia and ST-segment analysis
2)RESP Respiration rate(RR)
Respiration waveform
3)SpO2 Oxygen saturation(SpO2)
Plethysmogram(PLETH) waveform
Pulse rate(PR)
Bar graph
4)NIBP Systolic pressure(SYS), Diastolic pressure(DIA), Mean pressure(MEAN)
5)TEMP T1, T2, TD
6)IBP(optional) CH1:SYS,DIA,MAP
CH2:SYS,DIA,MAP
IBP waveform
7)CO2(optional) EtCO2
InsCO2:Inspired Minimum CO2
AwRR:Air Way Respiration
It has abundant functions, such as audible and visual alarm, trend data storage and output, NIBP
measurement, alarm event marking and drug concentration calculation, etc.
Performance
ECG Multi-parameter Portable Cardiac Patient Monitor FDA
Lead selection: I, II, III, aVR, aVL, aVF, V
Waveform: 5-lead, dual-channel
3-lead, single-channel
Gain: 2.5mm/mV, 5.0mm/mV, 10mm/mV, 20mm/mV, 40mm/mV
Scan speed: 12.5mm/s, 25 mm/s, 50 mm/s
HR: Measurement and alarm range: 15~350 bpm
Accuracy: ±1 % or ±1 bpm, whichever is greater
Alarm accuracy: ± 2 bpm
Resolution: 1 bpm
ST-segment monitoring:
Measurement and alarm range: -2.0 mV ~ +2.0 mV
Accuracy: -0.8 mV~+0.8 mV ±0.04 mV or ±10%, whichever is greater
Other range: unspecified
Arrhythmia analysis: ASYSTOLE, VFIB/VTAC, COUPLET, BIGEMINY, TRIGEMINY, R ON T, VT>2,
PVC, TACHY, BRADY, MISSED BEATS, PNP, PNC
Pacemaker: yes
RESP Method: R-F(RA-LL) Impedance
Respiration rate:Measurement and alarm range: 0~150 rpm
Resolution: 1 rpm
Measurement accuracy: ±2 rpm
Alarm accuracy: ±3 rpm
Apnea alarm: 10~40s
Scan speed: 6.25 mm/s, 12.5 mm/s, 25 mm/s
NIBP Method: Oscillometry
Mode: Manual/AUTO/STAT
Measurement interval in AUTO mode: 1/2/3/4/5/10/15/30/60/90/120/240/480/960 minutes
Measurement period in STAT mode: 5 minutes
Measurement and alarm range: 10 ~ 270 mmHg
Resolution: 1 mmHg
Cuff pressure accuracy: ±3 mmHg
Measurement accuracy:
Maximal mean deviation: ±5 mmHg
Maximal standard deviation: 8 mmHg
Over-pressure protection:
Adult mode: 297±3 mmHg
Pediatric mode: 240±3 mmHg
Neonatal mode: 147±3 mmHg
Spo2 Measurement and alarm range: 0 ~ 100%
Resolution: 1%
Measurement accuracy: 70%~100%: ±2%;
0%~69%: unspecified
PR Measurement and alarm range: 30 ~ 250 bpm
Measurement accuracy: ±2 bpm or ±2%, whichever is greater
TEMP Channel: dual-channel
Measurement and alarm range: 0 ~ 50ºC
Resolution: 0.1 ºC
Accuracy: ±0.1 ºC
EtCO2 Method: Sidestream or Mainstream
Measuring Range: 0~150mmHg
Resolution:0~69 mmHg, 0.1 mmHg
70~150 mmHg, 0.25 mmHg
Accuracy:0~40 mm Hg ±2 mm Hg
41~70 mm Hg ±5%
71~100 mm Hg ±8%
101~150 mm Hg ±10%
AwRR Range: 2~150 rpm
AwRR Accuracy: ±1BPM
Apnea Alarm: Yes
IBP Channel: dual-channel
Label: ART, PA, CVP, RAP, LAP, ICP, P1, P2
Measuring and Alarm Range: -10~300 mmHg
Resolution 1 mmHg
Accuracy: ±2% or 1mmHg, whichever is greater
Power supply: 100-240V~, 50/60Hz
Safety classification: Class I, type CF defibrillation-proof applied part
FDA-Approved Portable ECG Patient Monitor for Home and Hospital UseFDA-Approved Portable ECG Patient Monitor for Home and Hospital UseFDA-Approved Portable ECG Patient Monitor for Home and Hospital UseFDA-Approved Portable ECG Patient Monitor for Home and Hospital Use

About the Supplier

This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR244057". Items marked "verified" are certified.

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Yangzhou Kindsway Biotech Co., Ltd.
Yangzhou Kindsway Biotech Co., Ltd.
Yangzhou Kindsway Biotech Co., Ltd.
Yangzhou Kindsway Biotech Co., Ltd.
Yangzhou Kindsway Biotech Co., Ltd.
Yangzhou Kindsway Biotech Co., Ltd.
Yangzhou Kindsway Biotech Co., Ltd.
Yangzhou Kindsway Biotech Co., Ltd.

About Our Factory & Business Background

Address
198# North Shuangxian Road Xiannv Town Jiangdu District, Yangzhou
Terms of Payment
T/T, Western Union
International Commercial Terms(Incoterms)
FOB, CIF, EXW
Average Lead Time
Peak Season Lead Time: within 15 workdays
Off Season Lead Time: within 15 workdays
Nearest Port
Shanghai

Our Production Capability & Technical Expertise

Main Products
Ventilator, X-ray, Ultrasound, C-Arm, Slippers, Dr System, Cr System, Test Kit, Medical Equipment, Ambulance

Our Industry Experience & Global Business Record

Export Year
2011-09-27
Main Markets
North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe

FAQ

What monitoring parameters does the CMS8000 support?
It supports ECG, RESP, SpO2, PR, NIBP, dual-channel TEMP, and optional IBP and CO2 monitoring.
Is this device suitable for home use?
Yes, it is FDA-approved and designed for both home and hospital use.
What certifications does the monitor have?
The device holds FDA, CE, and ISO13485 certifications.
Can the NIBP measurement be automated?
Yes, it supports Manual, AUTO, and STAT modes with adjustable intervals in AUTO mode.
What are the ECG lead options available?
It supports 5-lead, dual-channel 3-lead, and single-channel configurations.
Does the device have alarm functions?
Yes, it features audible and visual alarms for various parameters and alarm events.
What is the power supply requirement?
It requires 100-240V~, 50/60Hz power supply.
Is data storage and output supported?
Yes, it includes trend data storage, output capabilities, and alarm event marking.

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