GLL0285-D Flow and Pressure Tester for Intravascular Catheter Power Injection

Flow and pressure test in power injection (only for power injection products) 1.
The principle connects the catheter to the actual or simulated connection line by the catheter seat or its adjacent end, and the connecting line is then connected to a constant pressure device filled with injection or simulated injection
.

The pressure of the pressure source is set to the product's recommended syringe pressure limit, while the system flow rate should be measured
by a mass balance or other conjunctive method.

The peak pressure at the inlet of the catheter should also be recorded
via an online pressure sensor.

2.
The flow and pressure tester in the dynamic injection of the instrument GLL0285-D intravascular catheter fully meets the requirements of
Appendix G in YY0285.
1-2017 "Intravascular Catheter Disposable Sterile Catheter".

Using 5.
7 inches (320 * 240) PLC colorful LCD touch screen, Chinese menu display
.

AD acquisition speed of 500KHz, internal code of 500,000; High-precision clock chip, power-off storage; PLC control dynamic display; Overload alarm shutdown protection; Test data
can be printed.

The instrument is composed of a flow valve (high pressure liquid pressure source), a pressure system specified by the standard, etc.
, using a special pneumatic hydraulic pipeline to ensure that the components have no leakage, digital display of liquid high pressure, with zero point correction, accuracy correction and overrange alarm function, the use of mechanical measurement of flow, high
flow control accuracy.

(equipped with temperature-controlled water tank).


3.
GLL0285-D Intravascular catheter power injection flow and pressure tester Main configuration: a.
Constant pressure device, guide tube and catheter connector assembly provide simulated injection solution, while maintaining the pressure in the clinically used pressure taxi range of 5%, the temperature is within the taxi range of 2 ° C at
the desired temperature.

b.
Injection solution or simulated injection
.

(e.
g.
mixture of glycerol and water or other) mixing so that the dynamic viscosity (kinematic viscosity/fluid density) of the target injection is within the desired 5% range
.

(See standard GB/T30515 and ISO3105:1994) Actual or simulated connection tube, inner diameter and length should be in line with clinical use
.

c.
Online pressure sensor and data logger, connected analog connection pipe end and catheter header
.

d.
System flow measuring device with an accuracy of 2%, e.
g.
quality balance and timer or flow meter
.

4.
Flow and pressure tester test steps in the power injection of intravascular catheters a.
Pressure device container fills human fluid and makes the liquid reach the required temperature
.

b.
Connect the connecting tube to the pressure device
.

c.
Connect the pressure sensor to the end
of the analog connection tube.

Prepare the catheter
as directed in the instructions for use.

d.
Connect the header to the online pressure sensor
.

e.
Limit the end of the catheter as required so that the injection can
be collected safely.

Exhaust all air
from the system.

f.
Adjust the pressure generation device to the pressure
required for the test.

G.
Start letting the fluid pass through the system and give enough time for the pressure and flow to reach a plateau
.

h.
When injecting, record the steady-state pressure
at the catheter inlet.

At the time of injection, the flow rate reached is recorded as follows: a) If the measurement method of continuous monitoring of flow is used, the steady-state flow rate
is recorded.

b) If a mass balance is used, the length of the collected injection should reach at least 15s or more, and its volume should be determined by measuring cylinder or weighing, using the density measured in G22 for flow calculation
.

5.
The test report test report shall include the following contents; a) identification of test catheters; b) a description of the injection solution, the dynamic viscosity (mPa·s) and density (kg/m) of the injection solution; c) Test liquid temperature (°C); d) pressure of the pressure source (Pa); e) Connecting pipe length and inner diameter (mm); f) steady-state flow (mL/s) achieved in the system; g) Pressure at the Population Division of the Catheter (Pa
).