The P-ECP /TI External Counterpulsation with SpO2

Operation Manual
Version：V2.4

Chongqing PSK-Health Sci-Tech Development CO.,Ltd

----------------------------------Please read this carefully before operation -------------------------------
 Table of contents
CHAPTER 1 PRODUCT INTRODUCTION ............................................................................................... 1

1.1 INTRODUCTION ................................................................................................................................... 1

1.2 CHARACTERISTICS ................................................................................................................................ 2
1.3 FUNCTIONS ........................................................................................................................................ 2
1.4 INDICATIONS OF ECP............................................................................................................................ 4
1.4.2 Convalescence ......................................................................................................................... 4
1.4.3 Health care .............................................................................................................................. 4
1.4.4 Allaying tiredness .................................................................................................................... 4
1.5 CONTRAINDICATION ............................................................................................................................. 5
1.5.1 Absolute contraindications ...................................................................................................... 5
1.5.2 Relative contraindications ....................................................................................................... 5
1.6 NECESSARY CHECK-UP BEFORE THE ECP TREATMENT ................................................................................... 6
1.7 PACKING LIST ...................................................................................................................................... 6
1.8 EXPLANATIONS .................................................................................................................................... 6
1.9 PRECAUTIONS ..................................................................................................................................... 7

CHAPTER 2 INTRODUCTION OF INSTALLATION ................................................................................... 9

2.1THE COMPONENTS OF P-ECP/TI EXTERNAL COUNTERPULSATION WITH SPO2................................................... 9

2.2 STEPS OF INSTALLATION......................................................................................................................... 9

CHAPTER 3 OPERATING PROCEDURES .............................................................................................. 11

3.1 OPERATION OF TREATMENT BED SYSTEM................................................................................................. 11

3.1.1 System startup ....................................................................................................................... 11
3.1.2 System startup window ......................................................................................................... 11
3.1.3 Main screen ........................................................................................................................... 12
3.2 STEPS OF THERAPY OPERATION ............................................................................................................. 17
3.2.1 Preparation check list ............................................................................................................ 17
3.2.2 Treatment procedure ............................................................................................................. 18
3.2.3 Clean up after therapy ........................................................................................................... 21
3.3 PATIENT INFORMATION MANAGEMENT SYSTEM ....................................................................................... 22
3.3.1 Start up of Patient Information Management System .......................................................... 22
3.3.2 The main windows of software ............................................................................................. 22
3.3.3 Unfolding patient’s database ................................................................................................ 24
3.3.4 Edit Patient’ basic database .................................................................................................. 26
3.3.5 Insert Patient ......................................................................................................................... 27
3.3.6 Delete Patient ........................................................................................................................ 27

CHAPTER 4 ROUTINE MAINTENANCE ............................................................................................... 29

4.1 WARNINGS ....................................................................................................................................... 29

4.2 CAUSES AND SOLUTIONS ..................................................................................................................... 29

CHAPTER 5 APPENDIX ...................................................................................................................... 31

5.1 WORKING ENVIRONMENT ................................................................................................................... 31

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5.2 EQUIPMENT DIMENSIONS AND WEIGHT .................................................................................................. 31
5.3 OPERATING VOLTAGE REQUIREMENT ..................................................................................................... 31
5.4 DEAL WITH THE CONSUMABLES ............................................................................................................ 31
5.5 INFORMATION OF MANUFACTURER ........................................................................................................ 31

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Symbol of production

General warning, caution, risk of danger

Please read the instructions carefully before operating the product.

Type BF applied part

Type CF applied part

The symbol indicating separate collection for electrical and electronic

equipment consists of the crossed-out wheeled bin

Manufacture’s Trademark

Date of manufacture

Manufacture

FRAGILE

Contents of the transport package are fragile therefore it shall be handled

with care.

THIS WAY UP

Indicates correct upright position of the transport package.

KEEP AWAY FROM RAIN

Transport package shall be kept away from rain.

 CHAPTER 1 PRODUCT INTRODUCTION

1.1 Introduction

New external counterpulsation with SpO2 (product model: P-ECP/TI) is based on

modern medicine, biomedical engineering, gas dynamics, computer technology,
embedded technology, modern control technology and modern industrial design.
Higher precision control, greater security of the treatment and better therapeutic effect
of external counterpulsation with SpO2 are reached. The device is not only stable and
comfortable, but equipped with the characteristics of refined appearance, small size
and low noise. The device can treat the coronary heart disease. As to the mechanism
of the treatment:
1) EECP can elevate the diastolic aortic pressure and blood volume, thus more blood
perfusion to the vital organs such as heart, brain and kidney.
2) EECP can decrease the myocardial oxygen consumption, since the drastically
fallen of the peripheral resistance in systolic phase facilitates the ejection of blood
from ventricle.
3) EECP can influence the theological properties of blood and the changes of some
certain bioactive substance.
4) EECP can improve the terminal circulation by increasing the blood circulation
and promoting the opening of the collateral branches and shunts.
5) EECP can inhibit the occurrence and development of atherosclerosis by
increasing the shear stress of the blood flow and improving the function of the
endothelial cells lining on the vessels.
P-ECP/TI External counterpulsation with SpO2 is a computer-controlled system
that applies external pressure via cuffs to the patient’s lower extremities in
synchronization with the patient’s cardiac cycle. When the heart is in its relaxed state
(diastole), pressure is applied sequentially, distal to proximal, from the lower legs
(calves) to the lower thighs and then the upper thighs and buttocks, to propel blood
back to the heart. The consequence is an increase in arterial blood pressure during
diastole (diastolic augmentation) resulting in increased coronary perfusion pressure
and coronary blood flow. Compression of the extremities also results in an increase in
venous return to the heart. Just before the heart ejects blood (systole), air is released
rapidly from all of the cuffs simultaneously to release the externally applied pressure,
allowing the compressed vessels to reform to their normal shape, thereby reducing
vascular impedance. As a result, arterial pressure during systole is reduced (systolic
unloading), as is cardiac workload. All components of the type of P-ECP/TI are
integrated in counterpulsation bed, which is a non-invasive, safe and effective
treatment of ischemic diseases device.

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1.2 Characteristics

Characteristics of the P-ECP/TI External Counterpulsation with SpO2

1) It adopts the high-tech new idea which combines the combines the
comprehensive medicine, computer, integration of machinery and industrial
design, etc.
2) It obtains the scientific data by using the blood stream dynamics technology &
drive pipe.
3) It adopts the high-tech computer technology and the digital circuit control; high
stability; strong antijamming ability.
4) The liquid-crystal display shows the ECG waveforms time to time. Automatically
adjust the time of inflation and deflation on the basis of the patient’s
physiological situation. It makes the treatment more effective and safer.
5) The computer screen showing the SpO2 waveforms reflect the treatment effect
time to time.
6) According to the patient’s actual situation, control the pressure automatically by
using the mouse.
7) The system has the patient data base; the patient’s information can be saved in the
treatment system.
8) It adopts the imported compressor and electrical magnetic valves, making the
advanced equipment smaller, low noise, low radiation and long life.
9) The design is reasonable, beautiful, direct-viewing and has the safety device.

1.3 Functions

1) Common mode rejection ratio: >80dB

2) QRS wave : < 0.20mV，
3) Automatic inflation stop and pressure release on early extra systole.
4) Automatic trace arrhythmia, keep the same pace of Counterpulsation.
5) Premature beat or deflation delay, use QRS wave trigger to deflate.
6) The simulated ECG software can make inflation and deflation automatically and
adjust the time.
7) Set treatment time from 1 to 60 minutes maximum
8) External trigger ratio: 1:1 or 1:2
9) Treatment time and left time displayed on the screen
10) A manual adjustment to Amp of ECG and SpO2
11) Inflated pressure displayed on the screen
12) Curves display panel displays ECG curve, curve of inflation and deflation and
SpO2 curve.
13) Keep the data of patients in order to be analyzed by doctor.
14) Set up the function of anti-pulsation limited inflation.
15) Automatically adjust the time of inflation and deflation.
16) Automatically air compressor stopped when treatment finished.

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17) Automatically air released when treatment finished.
18) Low-pass digital filter eliminates 50 Hz and high-frequency interference.
19) Ways of inflated pressure：arms, legs and buttocks—3 sequence；legs and
buttocks—3 sequence；legs—2 sequence（heart ratio: 120/min）.
20) Range of inflated pressure: 0～59kPa.
21) Protective function of limited pressure.
22) An emergency stop.
23) Working hours:  8 hours. Oxygen saturation LED light with wavelength of
660nm red light and 940nm infrared red light, the rated current of 30mA.
24) Oxygen saturation LED light with wavelength of 660nm red light and 940nm
infrared red light, the rated current of 30mA.
25) Keep patient quiet and remain him stationary, especially measured finger, while
operator measures the oxygen saturation.
26) Measurement range of SpO2: 70%-l00%.
27) SpO2 update time: a heart rate cycle--5 seconds
28) The time when patient wears the probe on the same finger do not exceed 2 hours.
29) The probe of the equipment has biocompatibility test report.
30) The probe uses Remo quick connector.
31) The probe is used for adult, worn on the finger—the best site monitored is index
finger, considering other fingers when the index finger is not available. Operator
cleans the measured finger and ensures it dry before wear the sensor to patient.
32) Elements affecting the measurement accuracy of SpO2: Cleanliness of
measurement site and stationary.
33) SpO2formula: :
Oxygen andhemeglobin
Spo2%  100%
Oxygen andhemeglobin  Deoxy-hemoglobin
34) Data updated time:5 seconds
35) If the data of SpO2 is less than 95%, the data shows in red, alarm indication.
36) The device is no pollution to the environment. Dispose scrap processing measures
of equipment and components in accordance with local laws and regulations.
37) When the acquisition signal is too weak, it will affect the SPO2 measurement
accuracy.
38) The equipment only uses the probe provided by our company. Operator ensures
that the probe is connected correctly before he uses.
39) Ground connection must be connected and reliable.
40) ECG electrode cable can not contact with other conductors, not with earth
contact.
41) Use medical electrodes.
42) The device can not be directly used for the heart.
43) The device can not be directly connected with other devices.
44) The device can be used for pacemaker patients.
45) Heart rate display range: Adult 30-125 ±2 bpm; Children 30-165 ±2 bpm.
46) The device has the tall T wave suppression capability.

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47) Heart rate calculation accuracy and speed of response: heart rate calculation error
of ±2 per cardiac cycle response time.
48) No heart rate over speed alarm.
49) Display scan speed: 25mm / s and 50mm / s.
50) The device with analog ECG feature can automatically charge and exhaust
counterpulsation. Charging exhaust timing can be adjusted automatically and
display in real time at the interface.
51) Treatment time of 1-60 minutes is continuously adjustable.
52) Counterpulsation ratio of 1:1 (one cardiac cycle counterpulsation 1) and 1:2 (two
cardiac cycles counterpulsation 1) two tranches.
53) Treatment time or the treatment remaining time is displayed in real time on the
interface.

1.4 Indications of ECP

1.4.1 For Treatment

The product makes clinical treatment of coronary heart disease for medical units.

1.4.2 Convalescence

1) Cardiac postoperative recovery

2) Convalescence of viral myocarditis
3) Convalescence of craniocerebral trauma and operation
4) Convalescence of traumatic paraplegia
5) Postoperative recovery of limbs
6) Convalescence of hepatitis
7) Memory decrease, insomnia, lethargy caused by old age
8) Convalescence of ischemia disease caused by other insufficiency of blood supply

1.4.3 Health care

1) Over the age of 50 but without ischemia disease

2) Mental labor
3) Disable or unwilling of outdoor activity group
4) With precursory symptom of ischemia disease (or sub-health group)

1.4.4 Allaying tiredness

1) Exertional disease
2) Mental fatigue

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1.5 Contraindication

1.5.1 Absolute contraindications

1) Obvious aortic insufficiency, counterpulsation can promote aortic blood reflux to

left ventricle.
2) Patent ductus arteriosus(PDA), counterpulsation may promote aortic blood reflux
to arteria pulmonalis.
3) Aortic aneurysm , dissection or ileofemoral arterial obstruction.
4) Valvular heart disease or congenital heart diseases or accompanied by cardia
insufficiency trend, serious pulmonary hypertension.
5) Cardiomyopathy, left ventricular hypertrophy, pacemakers, bundle branch block,
uncontrolled arrhythmia or coagulopathy.
6) Hemorrhagic disease, including haemorrhage or hemorrhagic tendency of brain
or other organs.
7) Infection focus caused by thrombophlebitis on limbs.
8) Pregnancy.
9) Patients with cardiomyopathy, serious congenital heart disease, significant
valvular diseases, left ventricular hypertrophy, pacemakers, bundle branch block,
uncontrolled arrhythmia, hemorrhage, coagulopathy, significant pulmonary
disease, thrombophlebitis and peripheral vascular diseases involving iliofemoral
arterial obstruction CANNOT use this device.

1.5.2 Relative contraindications

1) Severe hypertension, BP>170/110mmHg, please control the BP in normal range

with drugs before ECP. Patients with blood pressure higher than 160/100 mmHg
or a heart rate more than 120 bpm should be controlled prior to treatment with
enhanced external counter pulsation.
2) 2、Frequent bearing premature(>10～15 times/min)or paroxysmal tachycardia,
aerial fibrillation accompanied by pyknosphygmia (>100 times /min), sinus
tachycardia(>110 times /min),all should control in normal range with drugs
before ECP.
3) Left heart insufficiency
In medical record, myocardial infarction occurred many times, with big
ventricular aneurysm, dyspneic respiration at night or finally diagnosed cardiac
asthma, ultrasound, blood pool imaging or left ventricle imaging indicated ejection
fraction less than 0.4, or breathlessness after exertion and need resting more than 10
min to slow down, all indicated potential left heart insufficiency. In this case, don’t
treat with ECP or ECP with close monitoring. Administrate 10 mg isosorbide dinitrate
before ECP and closely monitor heart rate, respiration, rale, etc. If possible, oxygen
saturation should be monitored to discover lung edema.

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 It’s necessary to administrate glycerol trinitrate and monitor hemodynamics in
patients with acute myocardial infarction accompanied by left heart insufficiency.
ECP might provoke lung edema in patients with coronary heart disease accompanied
by left heart insufficiency, but some cases showed heart function improved more than
drugs could achieve.
4) Patient with Acute Myocardial Infarction and cardiac functional insufficiency
5) It depends on physical fitness when the patient is too old ,or over the age of 80.
6) Patients with blood pressure higher than 160/100 mmHg or a heart rate more than
120 bpm should be controlled prior to treatment with enhanced external counter
pulsation.
7) It depends on physical fitness when the patient is too old, or over the age of 80

1.6 Necessary check-up before the ECP treatment

In order to master the indication and contraindication of ECP exactly，

improve the safety of counterpulsation and observe the result of therapy. There
should be some necessary check-ups as to different ischemic diseases before the
ECP treatment.
1) Over 50 years old, no matter which kind of ischemic diseases patients get，a
check of cardiograph, ultrasonic cardiograph, blood pressure and biochemical test
of blood-fat .
2) Patients with Cardiovascular Disease, an examination of cardiograph, ultrasonic
cardiograph and ECT; Patients with Cerebrovascular Disease, an examination of
head CT or MRI; Patients with Vertebrobasilar ischemia, an examination of
TCD,OPS,γ -CBF, X-ray for neck and head CT.
3) Patients with Eye Disease, an examination of ERG, VEP, FFA.
4) Patients with Ear Disease, an examination of hear ability.
5) Patients with acrodynia, an examination of Power Doppler Sonography .
6) Digestive System Disease, a gastroscope, type-B ultrasonic are necessary.
7) Other ischemia caused by insufficiency of blood supply, patient need some
special examinations.

1.7 Packing list

1) A set of treatment bed

2) A Touch Screen Monitor.
3) Operation Manual, Certificate of Quality and Warranty Card.

1.8 Explanations

1) P-ECP/TI means that External Counterpulsation with SpO2 is designed and

manufactured by PSK-Health Sci-Tech Development Co., LTD.
2) Operating environment：

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 a. Temperature: 10 ℃~30℃ , when temperature is over 28 ℃, An air
conditioner should be installed to protect patients from skin hurt.
b. Relative Humidity: ＜70%.
c. Atmospheric Pressure: ordinary pressure
d. Dust-free, non-corrosive gases, and a well-ventilated, no strong
electromagnetic interference.
3) Power conditions: single-phase AC: 120V±12V 60Hz Power consumption:
2600VA
4) Safe and protective function：
a. ECG electrodes ≥ 4000V isolation, the pulse probe ≥ 2500V
isolation.
b. Function of pressure protection, working pressure≤59kPa。
c. Set up 2nd level inflated & deflated device when heart ration ＞120
d. Heart rate automatically stop counterpulsation in the following states,
tolerance of 2 times / min:
a) Adult: ＜35 times/min, ＞125times/min;
b) Child ( under 10 years old) ＜35 times/min, ＞165times/min
e. Automatically set up deflated protection when premature beat happened.
f. A function of emergency stop for counterpulsation.

1.9 Precautions

1) ECG waveform displayed on the interface should be used for counterpulsation

charge and exhaust trigger signal and the heart rate calculation ,but it cannot be
used as the basis of the doctor diagnosed ECG, using normal ECG diagnosis of
patient heart or cardiovascular situation.
2) Counterpulsation cannot use electrosurgical equipment.
3) The patient wearing a pacemaker can use this device under the patient medical
supervision.
4) Network power transient changes would interfere with the acquisition of the ECG.
ECG Cable should stay away from power lines.
5) Using silver / silver chloride ECG electrodes requires the AC resistance of the
electrode pads less than 3K, DC offset voltage of less than 100mv,the bias
currents tolerance less than 100mv.
6) ECG Cable with 6-pin 3-lead AHA type, demanding to register with the FDA.
7) When the input amplitude (ap) from ± 2 mV to ± 700mV,pulse width (dp) from
0.1ms to 2 ms pacing pulse, the device displays heart normal rate. Adult 30-125;
children 30-165.
8) Emergency stop button and power switch may exist leakage current , it can be
ignored in normal use. But the operator and the patient do not simultaneously
contact the emergency stop button and power switch.
9) Use of the product, the external components need to be inserted in accordance

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 with the marking on the instrument.
10) The oxygen probe optical probe should be demanded to register with the FDA.
11) Product warranty period of one year, the service life of 10 years; the oxygen
probe, ECG lines consumables according to manufacturer requirements.
12) Products and components over the life of the period,our company does not
undertake any responsibility.
13) Product maintenance need specially trained personnel to do.
14) Please run the device at least 30 minutes a week in order to protect the normal use
of the product.

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 CHAPTER 2 INTRODUCTION OF INSTALLATION

2.1The components of P-ECP/TI external counterpulsation with

SpO2

Fig.2.1 Sketch map of the whole machine

Explanation of Symbols ：
1.bed 2.indicator light 3.the total power jack 4.casters 5.air switch 6.refers to the pulse
line 7.the heart wires 8.fixed base 9.fixed trestle 10.touch screen monitor 11.backrest
12.emergency stop switch 13.power switch 14.bed surface 15.the leg pipe joints
16.the thigh joint trachea 17.the hip joints trachea 18.lower arm pipe joints 19.upper
arm pipe joints

2.2 Steps of installation

Caution:
Please ensure the working environment reaches the requirements of The P-ECP /TI External
Counterpulsation with SpO2 before installation.

Caution：
Read the contents of this part carefully before installation.

Step 1:
Open the packing box of treatment bed and then push to its right position. Please

ensure to loosen the caster’s brake of bed.

Step 2：
Adjust the position of the bed properly and then put on the brakes of caster

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(Explanation of Symbols :4 ).
Step 3：
Fixed base(Explanation of Symbols :8) with four screws is fixed on the bed (1). Pierce
the laptop (10)power cord and USB cable from the fixed trestle(9) and install it in a
fixed base (8).
Step 4：
Connect the power cord and USB to serial cable to the laptop, and the laptop is fixed
to the fixed trestle 8, according to the operator habits to choose USB mouse or the
computer touch keyboard.
Step 5：
Crush capsule set, thigh the capsule set, buttocks the capsule set and Forearm capsule
set are inserted respectively from 15 to 17 fast interface. Note that the capsule set
have left side and right side, to install the set should inward bandage. (Note: when
installing the set may need tools: beak clamp)
Step 6：
Take out the line of the finger pulse probe and plug it into the finger pulse
probe socket.
Step 7：
Take out the ECG cable and plug it into the Nihon Konden socket.
Step 8：
Insert the total power cord into the total power jack ( 3).
Step 9：
Make sure that the emergency stop switch 12 is in the unlocked position.
Step 10：
Open air switch, power indicator 2 lit.
Step 11：
Press the power switch (13), open the laptop power supply, and wait for the system
start-up.
Step 12：
Adjustable backrest comfort demand by the patient before the treatment can also be
adjusted by remote control or handle.

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 CHAPTER 3 OPERATING PROCEDURES

3.1 Operation of treatment bed system

3.1.1 System startup

Three ways to start up the system
1. Double click the icon” ECP-PSK For Adult” on the desktop to start up the
software.
2. Click “Start” → ”All program” → “ ECP-PSK” → ”ECP-PSK For
Adult” to start up the software.
3. Double click the Ecp.exe which is in the install directory(D:\ECP-PSK) to
start up the software.

3.1.2 System startup window

When software is startup, there is a flash about product and company on the
screen and then startup window(Fig.3.1) displays on the screen.

Fig.3.1 System startup window

Click button to start up the system and enter the adult mode which

is applied to treatment for adult patient, Click button to start up the

system and enter the emulated demonstrated mode which is applied to train operation
staff. Forbid use the Demonstration mode to treat any patient, otherwise
company has no responsibility for any accident.
According to the different mode, system would configure the proper parameter.
Under the treatment mode, system collects the physiological information of ECG and
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SpO2 Sensor, and as to the simulated feature of the patient’s ECG signals controls
valve system to continue the counterpulsation therapy. Under the demonstrated mode,
system generates simulated physiological information of ECG and SpO2 Sensor, and
as to the simulated feature of the patient’s ECG signals controls valve system to
continue the counterpulsation therapy.
Click button to shut down the software and exit.

Caution：
The Demonstration mode is only applied for demonstration and debug. It can not
to be used for real treatment. Or there should be bad effects on patients.In that
case ,hospitals or users should take all the responsibilities for it.

3.1.3 Main screen

The main screen of demonstration mode like fig.3.2. It’s the same with treatment
mode expect the “NOT for patients” caution.

Fig. 3.2 Demonstration Screen

1) Curves display area
Curves display area includes three panels. Curves display panel displays ECG
curve and SpO2 curve. Button panel include ten keys (one highlight), which allows
the operator to select (by clicking) one of the options described below. Right panel
include some information well be explained following.ECG Curve (first row): display

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the patient’s ECG signal. During the treatment (Fig. 3.3), the beginning of reading line
displays the inflation point. The end of reading line displays the deflation point. SpO2
signal (third row): display the patient’s SpO2 signal.

Fig. 3.3 during the treatment

2) Control area

“Stop” means the system is in Stop-Status and the curve is green as well as both
of the compressor and solenoid valves are stopped.
Double clicking this button under different 3 situations: 1. if system is
originally in Stop-status, then nothing happen; 2. if system is in Standby-Status, it will
cause system return to Stop-Status; 3. if system is in Treatment-Status, it will stop the
treatment and return to Stop-Status.

“Standby” means double clicking this button will change system into
Standby-Status with the solenoid valves start working, but the compressor is NOT
working. If system is originally in Standby-Status, double clicking this nothing will
happen
If system is in Treatment-Status, the text on this button will change to “Pause”.
Double clicking this button now will stop the work of compressor, but system is still
in Treatment-Status, and then the text on the button will change to “Come back”.
Double click this button again, the compressor will restart working, and the text will
change to “Pause” again.

When system is in Standby-Status, double click this button and system will
change to Treatment-Status. Both of the compressor and solenoid valves are start
working, and this means system start ECP treatment. In this case, this button becomes

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to show a clock of treatment time, just like: .

When double clicking Stop button or the treatment is completed, system returns to
Stop-Status with the compressor and solenoid valves stop working.Then the text of
this button returns back to “Start”.

1:1 or 1:2 stands for the immediate counterpulsation-rate during the ECP
treatment. (System default rate 1:1) “1:1” means one complete counterpulsation will
be triggered by one cardiac cycle (identified R-wave). “1:2” means one complete
counterpulsation will be triggered by two cardiac cycles (identified R-wave).

This button controls the inflation mode. (System default : 3 Steps)

The calf, thigh and buttocks are inflated-deflated orderly and sequently. Double
click “3 Steps” button, the mode changes to “2 Steps”, it means only the calf and thigh
are working, buttocks stop working.

After system startup, the display area is unfrozen and system keep drawing ECG
curve, Inflation-Deflation curve and SPO2 curve with keep changing all parameters.
After double clicking this button, the system stop drawing curves and parameters
changing stop. Double click this button again, the screen will return to unfrozen
status.

This button will be enabled when system works with database and system is in
the treatment-status. It will start the save after double click [Save] button (usually,
each saving lasts for 10 seconds) with the button disabled. After the save, the button
will turn back to be enabled again and you can repeat the save.You can save data
many times in each treatment, but just need to save a typical data is recommended.

Double click [Patient] button to access Patients Information Management System

(See Section 3.3). This button will be disabled when system without setting database
or when system is currently running.

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 When system is stopped, double click [Exit] button to exit this main screen and
enter into start interface. If system is in Standby or Treatment status, a dialog like
Fig3.4 will be displayed when double click [Exit] button. It will remind the operator
to stop the system first and then double click to exit.

Fig3.4 Dialog when click Exit button in Non-stop state

3) Parameter displayed and adjusted area

Inflation and deflation control area

Caution：
R-I and R-D is automatically set and safe range is fixed. So it will
not exceed safe limits.

Fig. 3.5 Inflation and deflation controlled area

Use the time adjust key to set the beginning of the red line

( start of inflation) directly on the ECG waveform by clicking the or key.

Each click on the / key advances/delays the beginning of inflation by 10

ms.

Use the time adjust key to set the beginning of the red line

(start of deflation) directly on the ECG waveform by clicking the or key.

Each click on the / key advances/delays the beginning of deflation by

10 ms.

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ECG parameter displayed and adjusted control area

Fig. 3.6 ECG parameter displayed and adjusted control area

Observe the ECG waveform on the top of screen. If a good quality ECG
signal is obtained (see Fig. 3.3), you should see the patient’s heart rate shown on
the screen, generated by the System in synchronization with the patient’s ECG.

Use the box to adjust the amplitude of the ECG waveform by

clicking the button or while observing the results on the screen. The
R-wave of the QRS complex should be about 1/2 to 1-inch in height.

SpO2 waveform displayed and adjusted control area

Fig. 3.7 SpO2 waveform displayed and adjusted control area

Use the SpO2 box to adjust the amplitude of the SpO2 waveform by clicking

the button or while observing the results on the screen. The amplitude
should be about 1/2 to 1-inch in height.

Pressure displayed and adjusted control area

Use this box to gradually adjust inflation pressure to the recommended by

click or key. Each click on the key increases/reduces the pressure of

0.001MPa. Greater pressure usually results in greater augmentation. As the
cylinder pressure control system is a high-inertia system, click the button to
increase or decrease the cylinder pressure, it will require a period of time to reach
the set pressure value. During the stable operation of the system, the deviation
between the current cylinder pressure and the set pressure value will not be more
than 0.003MPa.

Fig. 3.8 Pressure displayed and adjusted control area

Current time and working hour of air compressor displayed area

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 Fig. 3.9 Current time and working hour of air compressor displayed area
In this area, the first line displays the current date, the second line is the time.
The last line in this area shows the accumulative working hour of air compressor.

3.2 Steps of therapy operation

Caution：
1. Before the operating, please ensure both of the P-ECP/TI hardware and soft
ware installed
2. The therapy strictly rules to the EECP’s indication and contraindication.
3. During the therapy, do not keep away from the patient. The emergency-switch
button is beside the bed.
4. Before the operating, please read this manual.

3.2.1 Preparation check list

Caution：
Before EECP therapy, ask your patient go to the restroom if necessary .

Step1：
Laid the patient in bed, then adjusting the bed for the best comfortable and
convenient position.

Caution：
Avoiding hurt skin, we demand the patient wear cotton underwear.

Step2：
ECG electrodes positions: The red electrode is placed at the standard V4 position,
the fifth intercostals space on the left mid-clavicle line. The White electrode is placed
between the left clavicle and the first rib at the right sternal border. The Black
electrode is placed at the standard V4R position, on the right side of the chest at the
same height as the red electrode.
Check reliable link of ECG Cable and interface every time.

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 Caution：
Place the electrodes on a flat site over bone to minimize muscle artifact on the
ECG. Placement of the electrodes may be varied if the ECG waveform is weak or
motion artifact is encountered. Prominent R-waves are necessary to trigger
Inflation/Deflation. Dry shaving is recommended, as it removes excess hair and
surface residue from the skin.

Step3：
Apply (clip) the SpO2 Sensor Probe to the patient’s forefinger or middle finger
tip, placing the diodes against the finger pad. Position the patient’s arm pointing
upward in a resting position while keeping the elbow and wrist bent and the finger
curled in order to minimize motion artifact.

Caution：
The patient should be positioned supine in the centre of the Treatment Table.

Step4：
Before treatment, select the Cuff Set size that will fit the patient properly.
Selection of the Cuff Set size should be based on the patient’s waist-to-ankle
measurement.

Step5：
Cuffs should be wrapped in the following order: calf cuffs, lower thigh cuffs and
upper thigh/buttocks cuffs (see Fig. 3.3) and should be wrapped tightly to obtain
optimal diastolic augmentation with minimal skin irritation. However, do not wrap the
cuffs so tightly as to harm the patient

Caution：
Ask a male patient to hold his scrotum up against the lower abdomen, clear of
the lower thigh cuff, which must fit snugly high into the joint.

Step6：
Put the patient’s forefinger into the spO2 Sensor Probe placing the diodes against
the finger pad. If the red light is flashing, please adjust the probe or change another
finger.

3.2.2 Treatment procedure

Step1：Set-up

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 1-1：Press the System Power Button in the Console, the computer will start
automatically and enter the Main Menu Screen.
1-2：According to the methods in Item 3.1.2,start the hardware of EECP.(Before
the therapy, please click the music tag to choose music as you want.)
1-3：After log in, choosing the type of the therapy.
Step2：ECP Therapy
2-1：Observe the ECG waveform on the top of screen. If a good quality ECG
signal is obtained you should see the patient’s heart rate shown on the screen,
generated by the System in synchronization with the patient’s ECG. If the ECG
R-wave height (amplitude) is very low or very high, the red and/or white electrodes
may be relocated to yield the best ECG signal possible to satisfy stable triggering. If
excessive artifact is degrading the ECG signal, the heart rate will not be indicated on
the screen.
2-2：Observe the Sop2 waveform on the top of screen. Apply (clip) the SpO2
Sensor Probe to the patient’s forefinger or middle finger tip, placing the diodes against
the finger pad. Position the patient’s arm pointing upward in a resting position while
keeping the elbow and wrist bent and the finger curled in order to minimize motion
artifact.

2-3：Click the key to start the valve. The key will become
highlighted. The sound of the valves should be rhythmic and have a characteristic
pattern: three short beats-one longer, three short beats-one longer, etc.

2-4：Click the . A dialog box like Fig. 3.10 will appear.

Fig. 3.10 treatment information setting dialog box

Click the numeric keys on the right side of dialog box to input the Patient-ID.
Click button to clear Patient-ID. Click button to delete the last digit of

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 Patient-ID. Click the button on the right side of Treatment Time to adjust the

treatment time. Click button to start treatment. During treatment, Patient-ID

and patient’s name will be displayed on the top of the curve-display-area. (Fig. 3.11).

Fig. 3.11 displayed information during patient treatment

When operator inputs a wrong Patient-ID, a warning dialog like Fig 3.12 will be
displayed.

Fig 3.12 Dialog where input wrong Patient-ID

Click button to cancel the treatment and return back to Standby-Status.

If there is no use or setting of patient database, a dialog box like Fig 3.13 will
pop up. Input or choose the Therapy time and then click to treatment. Click

and get back to Standby-Status.

Fig 3.13 Treatment information setting dialog box without database

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 2-5：When treatment is finished or operator stop the machine, automatically
system is back to stop.

Step3：Power off
3-1：If there’s no further patient scheduled for the day, rotate the System Power
Switch to OFF position.
3-2：If the System Power Switch indicator light goes off, it indicates that the
System is shut-down.
3-3：Power supply is off.
Caution：
If you clicked the emergency-switch button when some incidents appeared,

please stop the therapy by clicking the , back to the beginning and
restart it.

3.2.3 Clean up after therapy

Step1：
Take off patient’s sensor cable, clean and reserve it well.

Step2：

In sequence take off the red, black and white electrodes from patient .Clean the
coupling agent which is from electrodes on the body of patient with a small amount of
alcohol.

Step3：
In sequence take off the buttocks cuffs, thigh cuffs and shank cuffs from patient.

Step4：
Help the patient get off the bed.

Step5：

Clean and reserve the cuffs well.

The equipment is not in direct contact with the body, so it need not disinfection.
Equipment maintenance personnel need only routine maintenance - sweep the dust.

Clean up / Disinfect the appliance after therapy

Step one:
Take off the three disposable electrodes from the patient and throw them into
trash bin.

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Step two:
Swab the coupling agent on the body which electrodes come with a small amount
of.

Step three:
Use alcohol spray to sprinkle to the area where electrodes pasted.

Step four:
Swab with a clean dry tissue on the area where electrodes pasted.

Step five:
Only link new disposable electrodes to the ECG cables for the next use.

Step six:
Use alcohol spray to sprinkle SpO2 sensors and wipe away the sebum from the
finger of patient who took treatment before with a cotton swab.

3.3 Patient Information Management System

3.3.1 Start up of Patient Information Management System

After the treatment, there are 3 methods you will find the Patient Information
Management System.

1. When the system under stop condition. click button.

2. Click “Start” “All programs” “ECP-PSK” “Patients
Information Management System”
3. Find the D:\ECP-PSK, and double click “PatientInfoManageApp.exe”

3.3.2 The main windows of software

After started the software, it appears a main windows(Fig 3.14).Patients’ basic
information are on the upper area and treatment records are on the lower. The
right-top corner are the operating buttons. Click the button on
the bottom-right corner to quit.

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 Fig. 3.14 Starting Screen of Patient Database

In this system, whenever or whatever you want to input, a soft-keyboard will pop
up (Fig 3.15. For example, when you input Patient-ID (Fig 3.16), or input patient
information(Fig 3.17), or input patient name in a popup dialog(Fig 3.18), the
soft-keyboard will be helpful.

Fig 3.15 Soft Keyboard

Patient ID

图 3.16 Left-Up corner of starting screen

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 Fig 3.17 Insert Patient Screen

Fig 3.18 Search Patient Screen

3.3.3 Unfolding patient’s database

Unfolding patient’s database
Unfolding it depend on patient’s number
Put patient’s number in to the main windows, you’ll find corresponding information.
Nothing appears means no existence. If it appears near the name (See fig. 3.16),
you should check the form.

Browse Patient

Click button, you will find the picture as follow(Fig. 3.19).

Click the gray block on the left of patient records to select a patient, the record will be
highlighted in blue, and a right triangle will appear. After selected a patient,
click button to close this dialog and display information of this patient.

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 Fig. 3.19 Browsing Screen of Patient Database
Search Patient
Click button to find out the patient’s information by his
name as shown in Fig. 3.20. In the text box, enter all or part of the patient's name (not
case-sensitive), then click button to start searching. If there is no result, no
information will be displayed on the main screen. If there is only one result,
information of this patient will be displayed. If there are more than one result, a dialog
similar to Fig. 3.21 will be popped up. Select one patient and click button
to display information of this selected patient.

Fig. 3.20 Finding Dialog

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 Fig. 3.21 Search and Select Patient Dialog

3.3.4 Edit Patient’ basic database

You should see the window shows patient information, Click
button pop up a Edit Patient Information as shown in Fig.

3.22. Edit whatever you want to edit, then click button to save the

edited information to database. Click button to cancel this operation

and return to main screen without save.

Fig. 3.22 Editing Screen of Patient Database

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3.3.5 Insert Patient

Click button pop up a Edit Patient Information as shown in

Fig 3.23. Input information of the patient, then click button to save the

information to database and return to main screen. Click button to cancel

this operation and return to main screen without save.

Fig 3.23 Insert patient

3.3.6 Delete Patient

Click button pop up YES or NO. Click button

to delete all information of this patient. Click to cancel this delete

operation and return to main screen.

3.3.7 Print Report

Click button pop up Patient Detail Report as shown in Fig.

3.24. You can input the hospital name, set date range of treatment record and copies
number. Then, click button to print information of this patient and brief
information of selected treatment record. The system uses the A4-size paper.

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 Fig.3.24 Print Report

3.3.8 Treatment Record Detail

If there has selected a patient, the treatment records should be listed in the lower
part of the main screen. Click the gray block on the left of treatment records to select
a record. The selected record will be highlighted in blue, and a right triangle will

appear. Then click the button on the bottom of main screen to

open a treatment record detail dialog like Fig. 3.25.

Fig.3.25 Detail Information of Treatment Record

Click button to close the window. Click button to

print the detail information of this treatment record.

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Delete Treatment Record
If there has selected a patient, the treatment records should be listed in the lower
part of the main screen. Click the gray block on the left of treatment records to select
a record. The selected record will be highlighted in blue, and a right triangle will
appear. Click the button on the bottom of main screen, a confirm
dialog will appear. Click button to delete this record, and click
button to cancel this operation.

CHAPTER 4 ROUTINE MAINTENANCE

4.1 Warnings

Due to violation of the the following precautions, our company does not
undertake any responsibility.
1. Without permission Do not disassemble P-ECP/TI.

2. You cannot install the irrelevant software and hardware in the treatment
system.

3. Bed, mattress surface as well as the capsule sets of surface dirt can be wiped
off with furniture care dedicated solvent, but never on the monitor screen.
4. Minimize the number of the starting up and shutdown,ensure that its interval is
more than 5 minutes.

4.2 Causes and solutions

Causes Reason Solutions

Bad contact both of the power Check and repair the power
Laptop cannot startup
supply and the switch supply and the switch
No signals of
Bad contact between the Check Serial Port Line and
ECG,Spo2 and
laptop and control panel panels
Pressure
Special valves out of Special valves broken/Bad Check 24 v power supply,

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working under the contact of Serial Port Line/ indicator light and the
condition of standby Bad contact of 24 v power special valves
supply
Bad contact between
Rejoin
electrodes and ECG’ s wires
No ECG’ s Bad contact between patient’s Clean electrodes and put it in
display ,or ECG’ s skin and electrodes accurate place.
display trouble Electrodes are in wrong places Put it in accurate place
ECG’ s wires are not
Rejoin
connected with control panel
All /Some of the
Check the control panel and
Cuffs have No Bad contact of the gas circuit
the gas circuit
Inflation & Deflation and the control panel
in the EECP Therapy
Some of cuffs have
Bad contact between cuffs and
no pressure in the Rejoin
hoses
EECP Therapy
All of cuffs have no
Bad contact between pump
pressure in the EECP Rejoin
and hoses
Therapy
RD point exceeds P wave’s
Adjust RD point by using the
Troubles in deflations peak and close to R
laptop/Clean it.
wave/Block in the deflation

If the problems cannot be solved, please contact us with service number

023-63830528

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 CHAPTER 5 APPENDIX

5.1 Working environment

Work temperature 10℃~30℃

Relative humidity ≤70%
Atmospheric pressure 86 to 106 kPa
Atmosphere Free of corrosive gas

5.2 Equipment dimensions and weight

Dimension:
Length×Width×Height: 2050mm×760mm×600mm

Net weight: 178kg

5.3 Operating Voltage Requirement

single-phase AC: 220V±22V 50Hz

consumed power: 2600VA

5.4 Deal with the Consumables

Sort out the used Consumables such as: Electrode Slice, Broken Cuffs and Hoses.
Broken ECG and Finger wires should get back to our company.

5.5 Information of manufacturer

Chongqing PSK-Health Sci-Tech Development CO.,Ltd

2nd Floor, Building H, #67 Keyuan 3rd Rd., Jiulongpo Dist., Chongqing China
Tel: 86-23-63833477
Fax: 86-023-63834594
Email: info@eecp.com.cn
Website: www.eecp.com.cn

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