1. Medical Device
i) Device Name: Bone Mixing System
ii) Model No.: CL006-03
iii)Catalogue No. (REF): CL006-03AE
2. Indications (Intended Use)
The Bone Cement Mixing System is for mixing of the bone cement powder.
3. Working Principle
This device mixes the bone cement evenly by hand.
1. Mixing bowl size (ODxH): About 113mm x 52mm; Cartridge size (IDxH): About 38mm x 153mm.
2. Net weight of the product: Not more than 0.2kg.
3. Sterilization: This device is sterilized using sthylene oxide before delivery.
4. Valid period (Shelf life): Three years.
5. This device can mix up to two units (total 80g powder) of bone cement of any viscosity.
Operating Instructions
1. Inspect the package prior to each use. Do not use the device if package is damaged.
2. Read the instructions for use, attached documents and labels.
3. Open the package, take out the product and operate the device according to following process.