The Changmei Balloon Inflator BI-20A-10 is a single-use, CE-MDR certified, ISO 13485 certified kyphoplasty balloon inflation device. It features a 20 cc nominal capacity and a maximum pressure of 30 atm, supplied preconfigured with a 10 ml syringe for immediate connection to 8G PKP balloon catheters such as the Changmei KB0210. Engineered for precise hydraulic pressurization, the inflator enables controlled dilation of the vertebral body and cavity formation for bone cement injection in PKP/PVP procedures.
Key Features
20cc Capacity – Nominal 20ml volume provides sufficient contrast medium for balloon inflation.
30atm Max Pressure – Build and hold pressure up to 30 atm to effectively dilate compressed vertebrae.
Preconfigured 10ml Syringe – Ready for immediate hydraulic connection, saving OR setup time.
Robust Materials – PC barrel and valves, PU connecting tube, silicone piston, and POM pull rod ensure burst safety and smooth operation.
Fluorescent Pressure Gauge – Screw-fixed dial readable in low-light OR conditions.
Ergonomic Handle – PC/ABS blend for comfortable one-hand pressure control.
Technical Specifications
Specification
Detail
Model
BI-20A-10
Nominal Capacity
20 cc (20 ml)
Maximum Pressure
30 atm
Syringe Supplied
10 ml, preconfigured
Intended Use
Hydraulic pressurization of kyphoplasty balloon catheters
Sterilization
EO sterilized, single-use
Regulatory
CE MDR, NMPA China Class II, FDA-cleared pathway
Models and Options
Standard configuration: BI-20A-10 with 20cc capacity, 30atm max, 10ml syringe. Custom configurations available upon request via OEM/ODM.
Orthopedic Surgery, Spine Surgery, Pain Management, Interventional Pain Clinics. Specifically for percutaneous balloon kyphoplasty (PKP) to treat vertebral compression fractures, restore vertebral height, and stabilize the spine.
Customization
OEM/ODM support available – can customize label, packaging, syringe size, and other specifications based on partner requirements. Minimum order negotiable.
Case Study
In a Kuwait clinical case implementing the egg shell technique, Changmei PKP systems demonstrated effective vertebral height restoration and kyphosis correction. The system's balloon inflator delivered reliable pressure, contributing to successful outcomes.
FAQ
1. What is the maximum pressure of the BI-20A-10? The maximum pressure is 30 atm, allowing controlled inflation of kyphoplasty balloons.
2. What is the nominal capacity? The nominal capacity is 20 cc, sufficient for balloon inflation in most PKP procedures.
3. Is the inflator supplied with a syringe? Yes, it comes preconfigured with a 10 ml syringe.
4. What sterilization method is used? The product is EO sterilized and designed for single use.
5. Which regulatory certifications does it hold? It is CE MDR certified, NMPA China Class II, and has an FDA-cleared pathway.
6. What materials are used in the inflator? Key components are made from polycarbonate, polyurethane, silicone rubber, POM, and PC/ABS.
7. Can we get OEM customization? Yes, OEM/ODM customization is available with negotiable MOQ.
8. How does the inflator benefit PKP procedures? It provides reliable pressure delivery, helping to dilate the vertebral body and form a cavity for cement injection, thus reducing pain and restoring height.
Inquiry Information
For orders and inquiries, contact Mark: cyz@czmed.com, Tel/WhatsApp: +86 138-1368-7682
Image: Kyphoplasty-10.jpg – Alt: Changmei BI-20A-10 balloon inflator with syringe and pressure gauge for kyphoplasty
