CE-MDR Certified Kyphoplasty Balloon Inflator (Model BI-20A-10)
Product Summary
The Changmei Balloon Inflator BI-20A-10 is a single-use, hydraulic pressure pump designed for kyphoplasty balloon inflation. With a 20 cc nominal capacity and a 30 atm maximum pressure, it provides controlled inflation to dilate the vertebral body and create a cavity for bone cement injection. Supplied preconfigured with a 10 ml syringe, it is compatible with 8G balloon catheters such as the Changmei KB0210. The device is EO sterilized and CE-MDR certified, ensuring safety and regulatory compliance for use in spine surgeries.
Key Features
- 20 cc capacity: Sufficient volume for kyphoplasty balloon inflation, reducing the need for multiple refills.
- 30 atm maximum pressure: Enables effective vertebral body dilation under fluoroscopy.
- Preconfigured 10 ml syringe: Ready for immediate connection to 8G balloon catheters, streamlining the surgical workflow.
- Polycarbonate and PU construction: High burst-safe strength and EO-sterilization compatibility.
- Fluorescent pressure gauge: Screw-fixed, ensuring clear readability in low-light OR environments.
- CE-MDR and ISO 13485 certified: Meets European regulatory standards for sterile medical devices.
Technical Specifications
| Model | BI-20A-10 |
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| Capacity | 20 cc (20 ml) |
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| Maximum Pressure | 30 atm |
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| Syringe | 10 ml (preconfigured) |
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| Sterilization | EO sterilized, single-use |
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| Regulatory | CE MDR, NMPA Class II, FDA-cleared pathway |
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| Materials | PC, PU, silicone rubber, POM, PC/ABS |
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Models and Options
This is the standard model BI-20A-10. Other models in the series may offer different syringe sizes or pressure ratings. Please contact our sales team for custom configurations.
Materials and Structure
The barrel, threaded sleeve, three-way valve, and joint are molded from polycarbonate (PC). The connecting tube is made of polyurethane (PU). The piston is silicone rubber, and the pull rod is acetal (POM). The push rod is PC, with an ABS option on the syringe pusher variant. The pressure gauge is screw-fixed with a fluorescent dial. The handle is ergonomic, made from a PC/ABS blend.
Applications
This balloon inflator is specifically designed for use in percutaneous kyphoplasty (PKP) procedures. It is used in orthopedic spine surgery, interventional radiology, and pain management centers. It is intended for the treatment of vertebral compression fractures caused by osteoporosis, trauma, or neoplasia. The device is also used in procedures for symptomatic vertebral hemangiomas. It is suitable for both hospital ORs and ambulatory surgical centers (ASCs).
Customization
Changmei offers OEM/ODM customization options for the balloon inflator, including branding, packaging, and minor specification adjustments. Minimum order quantity for customized products is negotiable. Please contact us to discuss your requirements.
FAQ
What is the maximum pressure rating of the BI-20A-10?
The maximum pressure is 30 atm (approximately 441 psi).
Is the balloon inflator reusable?
No, it is a single-use device. It is EO sterilized to ensure sterility and prevent cross-contamination.
What balloon catheters are compatible with this inflator?
It is designed to work with 8G balloon catheters, such as the Changmei KB0210. It can also be used with other compatible 8G systems.
What is the intended use of this device?
It is intended for hydraulic pressurization of kyphoplasty balloon catheters to dilate the vertebral body and create a cavity for bone cement injection in PKP/PVP procedures.
Is the device certified for use in the European market?
Yes, it is CE-MDR certified under Regulation (EU) 2017/745, issued by TUV SUD.
What materials are used in the construction?
The main components are made from polycarbonate, polyurethane, silicone rubber, and acetal (POM), all of which are compatible with EO sterilization.
Are there any specific storage requirements?
Store in a cool, dry place, avoid direct sunlight, and keep in its original packaging until use.
Can I request a sample before placing a bulk order?
Yes, samples are available upon request. Please contact our sales team for more details.
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