Automatic catheter balloon inflation diameter device

Whats/App: +86 156 1874 6768

Web: standard-groups.com

Applications

The catheter cuff inflated diameter tester is mainly used to measure the diameter of the cuffs of medical devices such as endotracheal tubes and tracheostomy tubes after inflation. This measurement is crucial for ensuring the safety and effectiveness of medical devices during use. By accurately measuring the inflated diameter of the cuff, it can help medical staff determine the appropriate amount of inflation. This aims to effectively seal the airway, prevent gas leakage and the aspiration of secretions into the airway, while also avoiding excessive pressure on the tracheal wall. In addition, this tester also helps to reduce complications such as tracheal mucosal injury, ischemia, and necrosis caused by excessive cuff pressure, improving the safety and effectiveness of endotracheal intubation.

Standards

ISO 5367：Medical devices — Connectors for breathing system tubes

YY 0337.1-2002:Endotracheal Intubation Part 1: Common Types of Endotracheal Tubes and Connectors

GB/T 15812.1-2005:Disposable sterile catheters — Part 1: General requirements

YY 0321.1-2009:Tracheostomy Tubes Part 1: Tracheostomy Tubes for Adults

YY/T 0321.2-2021:Tracheostomy Tubes Part 2: Tracheostomy Tubes for Pediatric Use

YY 0321.3-2009:Tracheostomy Tubes Part 3: Tracheostomy Tube Caps and Plugs

YY 0285.6:Disposable sterile intravascular catheters — Part 6: Central venous catheters

Technical Parameters

Parameter	Specification
Testing Range	Usually covers a pressure range of 0 - 10 kPa (or 0 - 1.45 psi) to meet inflation requirements of different cuffs
Accuracy	High accuracy (e.g., 0.5%FS full-scale error) to ensure test result accuracy
Air Source Pressure	Generally does not exceed 0.7 MPa; air source needs to be provided by the user
Air Source Interface	Usually a Φ8 mm polyurethane tube, for easy connection to air source equipment
External Dimensions	Compact design for portability:- Main unit: ~300 mm(L)×410 mm(W)×150 mm(H)- Device: ~215 mm(L)×215 mm(W)×240 mm(H)
Weight	Moderate (about 25kg) for easy handling and operation
Testing Principle	Adopts positive-pressure testing principle: Inflates the cuff with air to stretch/unfold wrinkles (minimizing cuff wall tension), then measures the inflated diameter

Accessoriess

Standard configuration: Main unit, hydraulic tank, miniature printer, customized connectors

Note: The air source interface of this machine is a Φ8 mm polyurethane tube; the air source must be provided by the user.

Test Procedures

1. Preparation

Ensure the measuring instrument is correctly installed and calibrated, and prepare the necessary endotracheal tube and cuff.

2. Connection

Connect the endotracheal tube to the sensor of the measuring instrument, ensuring a tight, leak-free connection.

3. Inflation

Inflate the cuff while observing the diameter value displayed on the measuring instrument.

4. Adjustment

Adjust the pressure within the cuff to the appropriate range based on the displayed diameter value.

5. Use

Once the adjustment is complete, the endotracheal tube can be inserted into the patient's airway, and the appropriate procedures can be performed.

6. Recording

During use, promptly record the diameter value displayed on the measuring instrument, as well as the corresponding operating steps and time.

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