Manual
Equipment required:
Not applicable
Method:
Rinse and soak Biodentine™ Gun in a non-glutaraldehyd disinfectant
Exposure time: at least 12min
Brush manually
Rinse under water
Dry during 30 minutes
Refer to precaution for use 7
Automated
Equipment required:
Ultrasonic cleaning machine
Enzyme detergent
Brush
Method:
Maximum exposure temperature: 40°C (104°F)
Maximum exposure time: 20 minutes
Brush manually
Rinse under water
Dry during 30 minutes
Sterilization
Equipment required:
Type B vacuum autoclave
Packaging pouch compatible with type B vacuum autoclave. Refer to warning 6
Method:
Wrap Biodentine™ Gun in an appropriate pouch for sterilization
Maximum exposure temperature: 135°C (275°F)
Maximum exposure time: 18 minutes
The instructions provided above have been validated by the manufacturer as being capable of preparing a device for reuse. It is
the processor's responsability to ensure that the processing achieved the desired result whatever the method, equipment and
staff involved. This requires verification and/or validation and routine monitoring of the process.
Inspection and maintenance
Visually inspect all surfaces. If any soiling is still visible, repeat processing step.
WARNINGS AND PRECAUTIONS FOR USE
Precautions for use
1. Wear the appropriate personal protective equipment while manipulating the device.
2. All the instructions must be carried out within the working area, far from the patient.
3. Refer to Biodentine™ XP instructions for use for cartridge preparation.
4. Use Biodentine™ Gun only with Biodentine™ XP cartridges otherwise, technical performances are not guaranteed.
5. Do not prime a cartridge, which is not locked at 90° in the Biodentine™ Gun.
6. Be cautious while handling and using Biodentine™ Gun so as not to inadvertedly cause harm.
7. Oxidizing disinfector solutions are not suitable because they alter the performances of the Biodentine™ Gun.
Warnings
1. Process the Biodentine™ Gun before first use because it is delivered non sterilized.
2. Do not process for more than 325 cycles. Otherwise, technical performances are not guaranteed.
3. Do not use Biodentine™ Gun after 325 cycles. Otherwise, technical performances are not guaranteed.
4. Do not use a damaged Biodentine™ Gun; it alters the performances of the device.
5. To avoid contamination between patients, ensure to always use a processed Biodentine™ Gun.
6. Use one pouch per Biodentine™ Gun, otherwise the sterilization is not guaranteed
5