DriveX™ Manual

Maintenance & Sterilization

To ensure proper hygiene and patient safety, all components must be thoroughly cleaned, disinfected, and sterilized before the first use and after each subsequent use.

Important Guidelines

• Follow national and local sterilization regulations.

• Use only disinfectants approved for medical devices (VAH/DGHM listed, CE marked, FDA-approved).

• Do not lubricate the motor handpiece.

• Do not clean the contra-angle in an ultrasonic cleaner.

• Do not use bleach or chlorine-based disinfectants.

• Use clean, demineralized water for the final rinse.

The user is solely responsible for ensuring sterility prior to each use. Always wear appropriate personal protective equipment (PPE) during handling and maintenance.

Autoclavable components

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Warning

Only the components listed above are suitable for autoclaving.
Before initial use and after each subsequent use, these components must be sterilized using steam sterilization..

CLEANING AND DISINFECTING

1 Preparation

Disconnect all components from the motor handpiece. Store instruments in a dry, clean environment — not in humid surroundings.

2 Transportation

Ensure safe and protective storage of all components during transport to avoid damage or contamination.

3 Pre-Decontamination

Disassemble the device completely prior to cleaning. Only disassembled parts should be reprocessed.

4 Manual Pre-Cleaning

Visually inspect and manually clean all components. Submerge them in cleaning solution and flush lumens with a cold water jet for at least 10 seconds. Use a soft-bristle brush for external surfaces.

5 Automated Cleaning

Preferred method due to consistency and safety. Place parts in a washer-disinfector tray and run the following cycle: • 4 min pre-wash with cold water (<40°C) • 5 min wash with mild alkaline detergent at 55°C • 3 min neutralization with warm water (>40°C) • 5 min intermediate rinse with warm water (>40°C)

 6 Desinfection 

Use an automated washer-disinfector with a validated thermal disinfection cycle. The recommended cycle includes:

5 minutes at 93°C (199.4°F)

This cycle has been validated to achieve high-level microbial kill, equivalent to industry-recognized disinfection standards. Use only FDA-cleared washer-disinfectors and ensure all cycle parameters meet CDC guidelines for reprocessing reusable dental instruments.

Note: All components must be placed in the washer-disinfector in a fully disassembled state. Follow manufacturer instructions for positioning to ensure complete exposure to heat and detergent.

7 Drying

Use automatic dryer cycle in the washer/disinfector. If needed, manually dry with a lint-free towel. Use sterile compressed air to dry internal cavities.

8 Maintenance

Inspect all components for damage or wear. Clean and disinfect any visibly soiled parts again. Lubricate the contra-angle as instructed.

9 Packaging

Use approved sterilization packaging to prepare clean and dry parts for autoclaving.

10 Sterilization

Perform steam sterilization at 135°C for at least 4 minutes. Allow 10 minutes minimum drying time post-cycle.

11 Storage

Store components in their sterilization packaging in a dry, clean, and dust-free environment until next use.

Use only FDA-cleared steam sterilizers (autoclaves) that are properly maintained and validated for use with dental instruments.
Before initial use and after every procedure, all sterilizable components must undergo steam sterilization.

Allow all components to cool completely before handling.
Before use, inspect the sterilization packaging to ensure it is intact, dry, and within its expiration date.
If the packaging is damaged, wet, or expired, the components must be repackaged and sterilized again.

Note: Disinfection alone is not sufficient. Steam sterilization is required before the first use and after every use.

Disinfection of other components

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