CL006-06-3BE Bone Cement Mixing System
1. Medical Device
i) Device name. Bone Cement Mixing System
ii) Model No: CL006-03
iii)Catalogue No. (REF)E, CL006-03BE
2. Indications (Intended Use)
The Bone Cement Moxing System to for mixing of the bone cement powder and liquid monomer.
3. Working Principle
This device mixes the bone cement evenly by hand
After mising the bone cement, connect the bone cement gun (optional) and inject (or fill) the bone cement into the medullary cavity or the desired location.
Specification
1) Mixing bowl size (OD×H). About 113mm 52mm, Cartridge size (IDxH): About 38mm 153mm
2) Net weight of the product: Not more than 0.2kg.
3) Leakage: The Cartridge and Plunger have good sealing performance, no leakage phenomenon.
4) Stenlization: This device is sterilized using ethylene oxide before delivery.
5) Valid period (Shelf life): Three years.
6) This device can mix up to two units (total 80g powder) of bone cement of any viscosity
Structure and Components
1) This device consists of Mixing bowl (1), Spatula (2), Funnel (3), Plunge rod (4), and Cartridge assembly [including Cartridge (7), Plunger (6), Nozzle (5)]
2) Associated devices: The Bone cement and Bone cement gun are not including in this device.
When used, the Cartridge of this product need to be connected with the Bone cement gun.
1) This device should be operated only by qualified professionals.
2) The bone cement powder and liquid monomer are not included in this device but prepared by the hospital. The bone cement must be prepared according to the instructions for use provided by the bone cement manufacturer
3) The bone cement gun is not included in this device but prepared by the hospital. The bone cement gun must be prepared and operated according to the instructions for use provided by the bone cement gun manufacturer.
4) This device is sterilized using ethylene onde before delivery.
5) This device is for single patient use only. Do not reuse and do not re-sterilize
6) This device should not be used after the expiry date shown on the package.
7) Follow current local/national regulations to properly dispose the device after use
B) During transportalion of this device, prevent severe shock, vibration, rain/snow, direct sunlight, moist and pressure.