[Intended Use]
NiTi Brush for peri-implantitis is intended for mechanical debridement and cleaning of titanium dental implant surface contaminated by osseous defect of plague, calculus or any other foreign body materials resulted from peri-implantitis, and NiTi Brush for peri-implantitis is designed for use in dental office by dentists, dental hygienists and trained dental assistants.

[Indication] : Peri-implantitis disease

[Side Effects] : Redness, Discomfort, Swelling

[Contraindications]
- It is contraindicated in young patient with poor attention and it can’t be used in non-implant surgery patients.
- Usage of the device for pregnant, pediatric or elder patient, there is no safety information, please consult to specialist

[Patient Population]
- Ages : adult
- Weight : Multiple
- Race : Multiple
- Patient condition : The NiTi Brush is used for patients who have dental implants.

[Intended Operator]
- Education : Expert trained who can use this medical device.
- Knowledge : Medical Knowledge
a) Read and understand ‘westernized Arabic’ numerals when written in Calibri font
b) Can distinguish: left arm, right arm
c) Understand hygiene
- Language : English or German (Languages offered in the instruction for use)
- Experience : Use by dentists, dental hygienists and trained dental assistants

[Checklist before Use]
- Recommended temperature for operation room is 15℃~30℃.
- The reactions of patient against or incompatibility with titanium or nickel.
- Visual inspection for breakage of package.
- Visually inspect the damage, breakage, deformation, pollution from any foreign material in NiTi Brush
- Sterilization the NiTi Brush according to the appointed sterilization method
- Preparing recommended handpiece for NiTi Brush.
- Preparing sterile saline solution(NaCl) for irrigation and cooling.
- Preparing 3% hydrogen peroxide solution for the multiple use in one patient using one NiTi Brush
- Understanding of instruction for use.

[How to Use]
- Open the outer box and pick the inner plastic box up.
- Open the inner plastic box and pick the NiTi Brush up
- Inspect the NiTi Brush for defects
- Pack the NiTi brush into the sterilization pouch
- Sterilize the NiTi Brush using autoclave.
- Attach the NiTi Brush in sterilized handpiece.
- Position the NiTi Brush to clean the targeted dental implant then clean the dental implant.
- Rinse extensively with sterile saline solution throughout the whole brushing time.
- In case of multiple use in one patient using one NiTi Brush, it is recommended to immerse the NiTi Brush in a 3% hydrogen peroxide solution and rinse with sterile saline before clean or debride another implant.

[How to connect between NiTi brush and Dental Handpiece]
- Recommended handpiece for NiTi Brush is the CE marked rotating implant motor(handpiece).
- Any handpiece that has the deceleration rate of “20:1” is recommended.
- Recommended RPM for operation is 600RPM ~ 1,200RPM.



[Caution]
- Only use by dentist or dental hygienist and trained dental assistants

[Warning]
- NiTi Brush must not be used in patients reporting reactions against or incompatibility with titanium or nickel.
- Do not use the brush in the broken inner plastic box.
- In case of damage, breakage, deformation, pollution from any foreign material in NiTi Brush, do not use it.
- NiTi Brush is non-sterile product.
- NiTi Brush must be sterilized according to the sterilization method & condition of instruction for use.
- After sterilization, use the NiTi Brush without re-packing or re-storage.
- Because of the risk for cross infection from patient to patient, NiTi Brush should be discarded after use.
- NiTi Brush is for single-use only. Do not re-use the NiTi Brush.
- Do not use if expiration date has been exceeded.
- NiTi Brush must be used in accordance with the instructions for use provided by the manufacturer.

[Sterilization Method & Condition]
- Preparing the sterilization of NiTi Brush and sterile the NiTi Brush in accordance with bellow condition.
- Autoclaving Procedure
 

- Keep the NiTi Brush in the sterilization pouch (or Sterilization Wrap) to keep it clean until you use it.

[How to Disposal]
- Manage the NiTi Brush according to the rules and guidance of the disposal for disposable medical device.

[How to Storage]
- Recommended temperature for storage is 15℃~30℃.
- Recommended humidity is 1% ~ 75%
- Keep away from the sunlight.
- Do not load or store any other materials on the NiTi Brush package.

[Expiry date]: 5 years from manufactured date.


■ PICTOGRAM

SYMBOL	DEFINITION	SYMBOL	DEFINITION
	MANUFACTURER		AUTHORISED REPRESENTATIVE IN THE    EUROPEAN COMMUNITY
	BATCH CODE (LOT NO.)		CATALOGUE NUMBER (MODEL NAME)
	CAUTION		CONSULT INSTRUCTIONS FOR USE
	DATE OF MANUFACTURE		DO NOT REUSE
	NON STERILE		USE-BY DATE
	KEEP AWAY FROM SUNLIGHT		KEEY DRY
	DO NOT USE IF PACKAGE IS DAMAGED

◆ Document No.: HKIFU-001
◆ Revision date: 2022.10.21 (Rev. 6)