P-ECP/TI EECP

Product Dimensions and Weight （P-ECP/TI）

Physical dimensions: length × width × height = 2070mm × 1120mm × 1100mm

Net weight: 220kg

Gross weight: 300kg

Certifications

U.S. Federal Drug Administration (FDA) cleared

-EC Certificate of Conformity (CE)

-ISO 13485: 2016

KF DA cleared/Korea

GOST R cleared/Russia

MDA/Malaysia

KEMENKES RI AKL/Indonesia

INVIMA registered/Colombia

Operation Environment

Ambient temperature: 10°C~30°C;

Relative humidity: less than 85%;

Atmospheric pressure (absolute pressure): 70kPa~106kPa;

Well ventilated and free of dust, corrosive gases and strong electromagnetic interference.

Power Requirements

AC single phase: 220V 50Hz/60Hz

Maximum power: 2.6KVA

Triggering Method

External trigger: R-wave of patient ECG

External trigger ratio: 1:1 or 1:2

ECG triggers range: 35~ 125 +2 bpm for adults

Pressure

Pressure setting range: 1kPa～50kPa

Pressure display range: 0kPa～60kPa

Blood Oxygen

Blood oxygen saturation monitoring range: 75% ~ 100%

Horizontal scanning speed: 25mm/s and 50mm/s

ECG Amplifier

Input impedance: >2 MΩ

Common mode rejection ratio: >80db

Heart Rate Measurement Range: 35bpm~165bpm

Adjustable gain range of ECG waveform: 1~32 steps

Heart rate protection range: For adults, lower than 40bpm or higher than 120bpm.

Inflation and Deflation

Minimum inflation start time is greater than 100ms at the heart rate of 40bpm~160bpm;

Maximum deflation start time is not greater than 700ms at the heart rate of 60bpm;

Inflation time difference between two adjacent sequences: children: 27ms±10ms; adults:

55ms±10ms.

Cuffs and Bladders

Six sizes fit all patients' types: XS, S, M, L, XL, XXL

Calf, upper thigh, buttocks are integrated

Backrest of the bed

Adjustable angle range: 0°~38°

Safe working load: 105KG

Remote control adjustable

Other

Treatment time setting range: 1min~60min

Solenoid valve response time: ≤50ms

Noise: ≤67dB

Safety protection function

ECG applied part24000V of high-voltage isolation

finger pulse probe 2500V of high-voltage isolation

Heart rate automatically stops counterpulsation in the following conditions: (Max: 165bpm) a) Adults: <35 bpm, > 125bpm b) Children (under the age of ten): <35bpm, > 165bpm

Automatic exhaust protection while premature beat

Hand-operated emergency button to stop counterpulsation

System protection function

ON/OFF switch on the machine is fused

Air/Vacuum Pump relay is overload protected

Functions and Characteristic

1. ECG and blood oxygen data collection

2. ECG waveform and numerical display

3. Only trigger wave can respond to counter-pulsation

4. ECG electrode detachment alarming

5. Heart rate protection

6. Premature beat protection

7. Suppression of tall T waves

8. Common mode rejection

9. SpO2 waveform and numerical display

10. Blood oxygen saturation over-limit reminding

11. Adjustable gain for ECG and SpO2 waveforms

12. Pressure adjustment

13. Operating pressure protection

14. Inflation/deflation time adjustment

15. Inflation/deflation time adjustment protection

16. Emergency stop

17. Mechanical restraint removing

18. Braking function

19. Real-time display of SpO2 waveform, D/S peak ratio, heart rate value, ECG waveform, inflation state, deflation state, treatment pressure and time

20. Selectable counter-pulsation ratio of 1:1 or 1:2

21. Manually adjustable mode of sequence

22. When the heart rate is too high, the sequential mode starts the 2 steps sequence function automatically

23. Selectable horizontal scanning speed

24. Patient information management function

25. Demonstration function

26. Adjustable lifting of bed backrest

Product structure and composition

The air-bag type sequential external counter-pulsation device (hereinafter referred to as counter-pulsation device) consists of control part (including control software), air circuit system, power supply system.

Treatment

After more than 20 years of clinical practice, indications of external counter-pulsation have developed from ischemic heart disease (IHD) to a wide range of ischemic diseases of brain, eyes, ears, limbs and other internal organs

Necessary examinations before counter-pulsation

Necessary and relevant examinations should be done for different ischemic diseases before counter-pulsation to know well the scope of application and contraindications of counterpulsation, increase its safety and observe its effects.

1. ECG, ultrasonic cardiogram, blood pressure, complete lipid, complete blood biochemistry should be checked for patients over 50 years old no matter what ischemic diseases they are suffering from.

2. ECG, exercise test (or ECT), ultrasonic cardiogram and heart functions should be checked for patients with cardiovascular diseases.

3. ECG and ultrasonic cardiogram should be checked for patients with cerebrovascular diseases. Cranial CT or MRI should be done for patients with cerebral thrombosis or cerebral infarction. Transcranial doppler (TCD), oscillatory potentials (OPs), local cerebral blood flow (γ-CBF), cervical vertebra X-ray and cranial CT should be done for patients with insufficiency of blood supply to their brain.

4. Examinations like vision, visual field, electroretinogram (ERG), visual evoked potential (VEP), fundus fluorescein angiography (for a few), and intraocular pressure (if necessary) should be done for patients with eye diseases.

5. Electroaudiometry should be done for patients with ear diseases.

6. Lower limb TCD should be done for patients with limb diseases.

7. Gastroscope, helicobacter pylori (Hp) respiration test (if necessary) and barium meal radiography (seldom used) should be done for patients with digestive ulcers. Liver function examination and B-ultrasonography should be done for patients with viral hepatitis.

8. For patients with the following diseases, such as long-term hypertension, ECG should be checked, blood pressure monitored for 24h and blood pressure measured before each counter-pulsation; for patients with frequent premature beats, ECG and 24h Holter should be done; for patients with diabetes, blood glucose should be checked; for patients with potential bleeding, thrombocyte and PT APTT should be checked.

9. Relevant special examinations should be done for patients with other ischemic diseases.

Precautions and warnings

1. It is the responsibility of the product owner to ascertain that all users are fully aware of all warnings and precautions for this product, and use the product in strict accordance with the operation manual.

2. The ECG waveforms displayed on the screen are only used for calculation of inflation and deflation trigger signals and heart rate during counter-pulsation, and cannot be used as the basis for doctors to diagnose the ECG. Please use specialized ECG monitors to diagnose the heart or cardiovascular conditions of patients. No waveforms other than trigger wave shall be used to respond to the counter-pulsation signal.

3. In case silver/argentic chloride ECG electrodes are used, the AC resistance, DC offset voltage and bias current tolerance shall be less than 3K, 100mV and 100mV respectively.

4. The ECG cables shall be of 6-pin 3-lead AHA Type.

5. The SpO2 probe is of photoelectric type.

6. This product is powered only via one power distribution unit and external power supply is not allowed.

7. Externally connected components should be well plugged as indicated by the marks on the device.

8. The operator and the patient should not touch the emergency stop button and the power switch at the same time.

9. Electrosurgery equipment shall not be used during counter-pulsation.

10. Patients using a cardiac pacemaker may use this product only subject to the decision of doctor.

11. The counter-pulsation device can support a maximum weight of 150kg. Please use it correctly.

12. To guarantee the normal operation of the product, please start it up and operate it for at least 30 minutes every week.

13. The product has a warranty period of 1 year and a service life of 10 years from the production date which is shown on the nameplate. The warranty period and service life of SpO2 cables, ECG cables and other consumables are subject to the provisions of other documents.

14. The Company assumes no responsibility for the product and its components used longer than their service life.

15. This product can be maintained only by professional personnel authorized by the Company.

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