Cardioplegic solution administration sets – five design options for blood and crystalloid cardioplegia during operations with сardiopulmonary bypass
Instruction
CSP Perfusion sets
01
General information
CSP perfusion sets are cardioplegic solution administration sets designed to deliver cardioplegia during cardiac surgery with сardiopulmonary bypass. Each component is designed for safety—from the air trap to the universal connectors for the oxygenator and roller pumps
Characteristics of the CSP delivery systems
Select a version to view the set contents
02
Scope of application
For use by trained medical personnel in healthcare settings
Field of application: transfusiology
TypeMI: 191430 "Set for administration of cardioplegic solution"
The medical device is sterile, single-use, category A (less than 24 hours), indirectly contacts the bloodstream
Risk class 2a
03
Purpose
Delivery of a cardioplegic solution to protect the heart from ischemia and reperfusion injury. The method (hypothermic, moderately hypothermic, normothermic, blood, or crystalloid) is determined by the treatment plan. This product is single-use, non-toxic, non-pyrogenic, and sterilized with ethylene oxide.
Design options
The choice of one method or another is determined by the type of cardioplegia
CSP.1 - for delivery of normothermic and moderately hypothermic blood cardioplegic solution
CSP.2 is similar to KSF.1, except for the built-in heat exchanger, which is used to cool the blood cardioplegic perfusate
CSP.3 is similar to KSF.1, but supports only a single cardioplegic solution container connection
CSP.4 - for crystalloid cardioplegia, does not contain a blood supply line
CSP.6 - is similar to KSF.4 in composition and purpose, except that it accommodates only one cardioplegic solution container
04
Indications and contraindications
Indications
Cardiac surgery with сardiopulmonary bypass and on a clamped aorta
Contraindications
Dissection of vessels depending on the area of perfusion
Side effects
Postperfusion syndrome
Insufficient anticoagulation → obstruction of the extracorporeal circuit and the patient circuit, which can lead to hemolysis, thrombus formation
05
Operating procedure
1
It's important to check the expiration date and the packaging for leaks. When removing the line from the packaging, it's important to observe aseptic technique.
2
Next, connect the silicone tubing of the common cardioplegia line to the roller pumps of the cardioplegia attachment. For blood cardioplegia, the line is connected to both roller pumps (options KSF.1, KSF.2, KSF.3); for crystalloid cardioplegia, the line isconnected to only one roller pump (options KSF.4 and KSF.6).
3
The common cardioplegia line is connected to the main solution container using a two-channel polymer needle (or, if necessary, to an additional container in the KSF.1, KSF.2, and KSF.4 variants). In the case of blood cardioplegia (KSF.1, KSF.2, and KSF.3), the blood supply line is connected to the coronary perfusion port of the oxygenator via a connector (1/4" x 1/16" connecting tube). The port and tube ends are pre-treated with an antiseptic solution. The line is then filled with perfusate.
4
After the line is filled and air is removed, the roller pumps are stopped and a clamp is applied to the main line. If necessary, connect an external invasive pressure monitoring line.
5
Remove the solution supply line from the bag, connect it to the main line, turn on the roller pumps, and fill the lines with the mixture, removing any air bubbles. Clamp the end of the solution supply line.
6
The cardiac surgeon connects the solution supply line to the cardioplegic cannula and removes air bubbles.
7
To administer cardioplegia, remove the clamp from the line and turn on the roller pump at a speed in accordance with the selected technique.
8
At the end of cardioplegia, a clamp is applied to the line leading to the cannula and the roller pumps are stopped.
06
Warnings
Do not use the product if the packaging is damaged
Avoid kinking the line and do not use lubricants
It is important to ensure that perfusion meets the required parameters; excess pressure can cause vascular damage or insufficient perfusion
It is necessary to control the liquid level in the bubble trap and in the containers with the solution
If air gets in, repeat the procedure to remove it
This is a single-use product; re-sterilization and repair are not possible
The manufacturer is not responsible for use of the product for other purposes or in violation of the instructions
07
Storage and transportation
Transportation: from –50 to +50 °C, humidity up to 98% at 25 °C
Storage: from +5 to +40 °C, humidity up to 80% at 25 °C, on shelves, no closer than 1 m from heaters
Protect from moisture, high temperatures and direct sunlight
Shelf life: 5 years
08
Warranty and disposal
The guaranteed shelf life is equal to the expiration date
Complaints are sent to the manufacturer
Dispose of used products as Class B waste (yellow packaging, disinfection, thermal destruction). Unused products are treated as Class A waste
09
Manufacturer’s contact information
Manufacturer
JSC KARDIOSYSTEMFARMA (JSC KSF)
141401, Moscow Region, Khimki, Khimki, Rabochaya St., 2A, building 1, floor 5, office 93
Place of production
LLC "Savga MD"
350072, Krasnodar region, Krasnodar, st. Moskovskaya, 96/1
Place of production (sterilization)
STERIPAK SERVICE LLC
117246, Moscow, Nauchny proezd, 10, rooms 303, 316
JSC "CARDIOSYSTEMPHARMA"
Owner LP-No.(015032)-(RG-RU)
2a-1, Rabochaya, St. Khimki, Moscow Region, 141401 Russia
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