nova instruments Instructions for use guidelines.

Instructions for use.

Dental Hand Instruments

New Dental Hand Instruments must be sterilized prior to patient use. The instruments are reusable and should be sterilized using steam sterilization only.

Product Description

The Dental Hand Instrument product instrument groups consist of diagnostic, periodontal and restorative hand instruments.

Intended Use

Nova Dental Hand Instruments are to be used by Dental Trained Professionals and only in professional dental settings.

The Instruments are to be used in accordance with industry standard dental practices for the instrument’s intended purpose.

Warnings and Precautions

  • Improper use of Nova Dental Hand Instruments is unsafe and may cause harm to the dental professional and/or patient.
  • Nova Dental Hand Instruments are resistant to reprocessing and the lifespan of the instrument is determined by wear and damage from use.
    Before every procedure where Nova Dental Hand Instruments are used, the trained professional must:
  • Clean off visible debris from the instrument.
  • Place in a decontamination/disinfection bath following the decontamination and disinfection procedures.
  • Use steam sterilisation via an autoclave.
  • Prior to any additional use of the Hand Instruments the trained professional must visually inspect the Dental Hand Instrument(s) for any damage, corrosion, or defects that could cause the device to be unsuitable for patient use. If any of these characteristics are found, discard the device in accordance with local regulations for possible contaminated devices if not sterilized.
  • Use only CeFDA approved medical or dental reprocessing equipment and neutral PH enzymatic cleaners.
  • It is the users responsibility to follow the manufacturer’s instruction for alternative reprocessing procedures.
  • Use of cleaning chemicals that contain Aqua Regia, iron chloride, sulfuric and hydrochloric acid, and iodine should be avoided.
  • It is the users responsibility to verify the functionality of a disinfection unit and steam autoclave at regular intervals by having it serviced and calibrated according to the manufacturer’s recommendations.
  • If a device arrives unsuitable for patient use, contact Nova Customer Service. Small tears in the instrument packaging is acceptable if the instrument is undamaged.

Reprocessing Instructions

  • Do not use an abrasive pad, metal brush, or steel wool for cleaning as they could cause micro abrasions that could damage the Dental Hand Instrument.
  • Dissimilar metals should not be processed together. If unlike metals are batched together, a potential for electrolytic reactions between dissimilar metals will exist, which can produce etching and corrosion on the instrument surfaces.
  • The devices should not contact each other to prevent contact damage and surface shielding of cleaners or steam.

Point of Use Debris Removal (Optional)

  • Remove bioburden and debris from devices as soon as possible to prevent residual adhesion.
  • If manual decontamination cannot be performed immediately, place the device in a covered container, submerged in distilled water or in a bath of neutral PH enzymic cleaner, follow the cleaner manufactures instructions. Do not soak longer than 60 minutes.

Manual Decontamination

  • In a tub, prepare a fresh bath of cleaning solution with a PH neutral enzymatic cleaner, follow the manufacturer instructions for concentration, time, and water quality.
  • Submerge the instruments and use a soft-bristled nylon brush on each device for at least 30 seconds hitting all surfaces of the device.
  • Thoroughly rinse the instrument in tap water for 30 seconds to remove visible contaminants and cleaning solution.
  • Dry with a clean cloth, inspecting the device to ensure all contaminants have been removed. Repeat as necessary if visible debris or contamination is still visible.

Manual Disinfection

  • Prepare a fresh sonic bath with a cleaner/disinfectant, follow the manufacturer instructions for concentration, time, and water quality.
  • Load instruments into a cassette or ultrasonic mesh basket. See warnings in Reprocessing Instructions section for instrument contact and reprocessing of dissimilar metals.
  • Process the devices, following the manufacturer instructions for concentration, time, temperature and water specification.
  • Remove the device from the sonic bath, for best results rinse in distilled or filtered water for 30 seconds to remove any cleaning fluids.
  • Allow the device to dry following the rinse, using a clean cloth if necessary to
  • expedite drying.
  • Place the disinfected instruments in a disinfected cassette or sterilisation pouch for sterilisation.

Auto Washer Cleaning/Disinfection Settings

  • Always follow the auto Washer/Disinfectant and sterilising equipment manufacturer’s recommendations for time, temperature and water quality.
  • Carefully load the instruments into a cassette or other container. See warnings in Reprocessing Instructions section for instrument contact and reprocessing of dissimilar metals.
  • Pre-rinse with cold tap water for 1 minute, Wash at 55°C for 5 minutes with distilled water
  • Post rinse in cold demineralized water for 2 minutes, Thermal Disinfection at 93°C for 5 minutes, use machine settings for drying.
  • Place disinfected instruments into a sterilising pouch, cassette, or other disinfected container for transfer to sterilisation.

Sterilising Settings

  • Place instruments into the steam autoclave unit and process the instruments according to the manufacturer’s recommendations.
  • A sterilisation Test Strip is recommended to be placed in each autoclave cycle to monitor the sterilisation process.
  • See Reprocessing Instructions section for warnings of instrument contact and reprocessing of dissimilar metal.

 

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