ReLeaf RESTORATIVE Basic Setup Kit Instruction Manual

Insert the larger knob into the opposing hole at the Leaf
tip.
Squeeze the two halves of the Leaf together to ensure they
securely attach to each other.

Attach the Leaf to the Restorative Adapter on the Short Hose
with the smaller leaf face facing away from the hose.
Ensure the Leaf is securely attached.

Patient Use

Attach the free end of the Short Hose to the Quick Disconnect
Adapter on the Long Hose.
Insert the coupler at the other end of the Long Hose securely
into an open HVE port.

When transitioning between patients, use cleaned and sterilized
Bite Block, Restorative Adapter, and Short Hose before attaching a
new Leaf.

Sterilization, Disposal, and Storage

All gray and white components of the ReLeafTM system are
compatible with standard dental sterilization protocols.

Wipe with dental-approved disinfectant wipes or sprays
Run through dental atomizer

Process through an ultrasonic bath
Run through a thermal washer

Run through autoclave cycle per sterilization cycle table

Leaves: One Time Use, Disposable. Dispose in a
clinical waste container after single use.

FAQ

Q: Are there any contraindications for using the ReLeaf
Restorative system?

A: No known contraindications have been identified.

Q: What precautions should be taken while using the
product?

A: Risk of allergic reactions cannot be excluded for those
predisposed to allergies.

Q: How should loose connections be addressed?

A: If you find the coupler becoming loose, it may be necessary
to replace the O-ring.

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®
RESTORATIVE — Instructions for use
https://releafdental.com/pages/releaf-restorative

PRODUCT DESCRIPTION/INTENDED USE
ReLeaf® Restorative is a hands-free, high-volume dental suction device that assists practitioners with evacuation, isolation, retraction, and maintaining a dry field during general dentistry, restorative, and hygiene procedures. ReLeaf® is for clinical use by dental professionals.
The Leaf mouthpiece comprises a soft, flexible thermoplastic elastomer that is 100% BPA and latex-free. No health hazards have been identified with the use of this material.
The ReLeaf® hoses comprise of a silicone rubber (silicone and silicon dioxide).

Restorative Adapter Restorative Leaf

Bite Block

Short Hose

HVE Adapter Long Hose

Quick Disconnect Adapter

INSTALLATION AND PATIENT USE
1. Fold the two Leaf halves together by pushing together the small protruding knob into the opposing hole at the Restorative Leaf base. Insert the larger knob into the opposing hole at the Leaf tip. Squeeze the two halves of the Leaf together to ensure each side securely attaches to the other. Attach the Leaf to the Restorative Adapter on the Short Hose (8″ Quick Disconnect Hose) with the smaller leaf face facing away from the hose. Ensure the Leaf is securely attached.
2. Insert the ReLeaf® Bite Block onto the peg closest to the Leaf on the Restorative Adapter. Making sure the concaved slope is in contact with the Restorative Leaf.

3. Attach the free end of the

Short Hose to the Quick Disconnect Adapter on the Long Hose (48″

HVE Attachment Hose). Insert the coupler at the other end of the Long

Hose securely into an open HVE port. It may be necessary to wet the

O-ring inside the unused port so the Adapter can slide in easily.

4. Place the ReLeaf® Bite Block on the opposing arch you are working on. While having the Leaf sweep in front of the tongue and wrap around the retromolar area to the opposing cheek side.

5. When transitioning between patients, a cleaned and sterilized Bite Block, Restorative Adapter, and Short Hose must be utilized before attaching a new Leaf.

CONTRAINDICATIONS
No known contraindications.

PRECAUTIONS
Risk of allergic reactions cannot be excluded for those predisposed to
allergies.

STERILIZATION, DISPOSAL AND STORAGE
All gray and white components of the ReLeafTM system are compatible with standard dental sterilization protocols. These parts can be: wiped with dental-approved disinfectant wipes or sprays, run through dental atomizer, processed through an ultrasonic bath, run through a thermal washer, and run through autoclave
cycle per sterilization cycle table.
Leaves: One Time Use, Disposable The disposable Leaves are meant for single use only. Due to the nature of the material and design of the Leaves, they should not be sterilized and reused. Leaf mouthpieces must be properly discarded in a clinical waste container to prevent transmission of infectious pathogens.
Bite Block, Restorative Adapter and Short Hose 100% Autoclavable and Reusable. Before placement in an ultrasonic cleaner, rinse the Bite Block, Restorative Adapter and Short Hose with water and brush both external and lumen surfaces with a soft bristle brush for the exterior surface and a soft bristle lumen brush or pipe cleaner for the interior surfaces. Place in an ultrasonic unit filled with enzymatic cleaner. (note: follow instructions with enzymatic cleaner for proper mixing, exposure time, etc., per manufacturer instructions). Rinse with water, place in an autoclavable pouch. Run product through a wrapped / pouched cycle in the autoclave.
Long Hose, Quick Disconnect Adapter and HVE Adapter 100% Autoclavable and Reusable. The Long Hose should stay connected to the HVE until ready for routine evacuation cleaning with an enzymatic evacuation cleaner. Running evacuation cleaners through the hose to clean out any debris at least once per week is recommended. It is not necessary to run evacuation cleaners through the hose between each patient. If running through the autoclave, follow instructions listed above for Bite Block, Restorative Adapter & Short Hose.
Storage Please ensure Releaf® is stored at room temperature. The Long Hose and Short Hose are designed to be held in the HVE Adapter when unused. (See image)

VALIDATED STERILIZATION CYCLES
Gravity Displacement Autoclave
TEMPERATURE: 121°C/250°F MINIMUM EXPOSURE TIME: 30 minutes MINIMUM DRY TIME: 30 min

VALIDATED STERILIZATION CYCLES

Gravity Displacement Autoclave

Pre-vacuum Autoclave

TEMPERATURE: 121°C/250°F

TEMPERATURE: 132°C/270°F

MINIMUM EXPOSURE TIME: 30 minutes

MINIMUM EXPOSURE TIME: 4 minutes

MINIMUM DRY TIME: 30 min

MINIMUM DRY TIME: 20 minutes

TROUBLE SHOOTING
Proper Releaf® Restorative Position Ensure the long end of the Restorative Leaf wraps around the retromolar area on the quadrant you are working on. To assist in evacuation, when a small amount of water and saliva build up behind the Restorative Leaf, have the patient slowly push their tongue against the Leaf while closing down on the Bite Block. This will evacuate any remaining water that flows behind the Leaf.
Loose connection If you find the coupler becoming loose, it may be necessary to replace the O-ring.

Releaf® is a registered trademark of Innovative Dental Technologies, Inc. Must be sold by or on the order of a dental professional only. Use of this devices is prohibited for any other purpose than recommended by the manufacturer.
50-90û F

Documents / Resources

ReLeaf RESTORATIVE Basic Setup Kit [pdf] Instruction Manual
RESTORATIVE Basic Setup Kit, RESTORATIVE, Basic Setup Kit, Setup Kit, Kit

References

User Manual

ReLeaf RESTORATIVE Basic Setup Kit Instruction Manual

RESTORATIVE Basic Setup Kit

Specifications

Product Usage Instructions

Installation