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Balloon Inflator

Inventário:
SKU: 8988898826
Modelo: BI-20A-10

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CHANGMEI Kyphoplasty
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Product Specification

TypeBalloon Kyphoplasty (PKP) AccessoriesModelBI-20A-10
ParamsModel: BI-20A-10 Device Class: Kyphoplasty Balloon Inflator / Balloon Inflation Pressure Pump (PKP accessory) Nominal Capacity: 20 cc (20 ml) Maximum Pressure: 30 atm Syringe Feature: Supplied with 10 ml syringe (preconfigured) Intended Use: Hydraulic pressurization of kyphoplasty balloon catheters (e.g., Changmei KB0210 8G) to dilate the vertebral body and form a cavity for bone cement injection in PKP/PVP. Sterilization: EO sterilized, single-use Regulatory: CE MDR certified, NMPA China Class II, FDA-cleared pathway claimed by manufacturerMaterialBarrel / outer tube / threaded sleeve / joint / three-way valve: Polycarbonate (PC) Connecting tube: Polyurethane (PU) Piston: Silicone rubber Pull rod: Polyoxymethylene (POM) Push rod: PC (main) / ABS (on syringe pusher variant) Pressure gauge: Screw-fixed, fluorescent dial for low-light OR readability Handle: Ergonomic PC/ABS blend
Applicable IndustryOrthopedic Surgery​, Spine Surgery, Pain Management, Interventional Pain Clinics

Feature

The Changmei Balloon Inflator BI-20A-10​ is a single-use, CE-MDR and ISO 13485 certified kyphoplasty balloon inflation device​ with a 20 cc nominal capacity​ and 30 atm maximum pressure, supplied preconfigured with a 10 ml syringe​ for immediate hydraulic connection to 8G PKP balloon catheters such as the Changmei KB0210. The barrel, threaded sleeve, three-way valve, and joint are molded from polycarbonate (PC), the connecting tube from polyurethane (PU), the piston from silicone rubber, the pull rod from POM, and the push rod from PC/ABS, giving the inflator high burst-safe strength and EO-sterilization compatibility. A screw-fixed fluorescent pressure gauge, O-type low-friction plunger, and ergonomic handle let surgeons build and hold 30 atm steadily while dilating the vertebral body under fluoroscopy, and the optimal head fluid channel supports quick venting before lock-in. As the inflation counterpart of the Changmei 8G Kyphoplasty System—pairing with KT-00-01 tool kit and KB0210 catheter—the BI-20A-10 is built for tertiary hospital spine ORs, ASCs, and interventional radiology suites performing percutaneous balloon kyphoplasty (PKP).

Kyphoplasty

Kyphoplasty