INDICATIONS FOR USE

ISORetract™ Mouth Retractor

Non-sterile, reusable, sterilize after each use.

USER QUALIFICATION

The ISORetract™ Mouth Retractor is a professional, reusable dental cheek retractor for use by orthodontic or dental healthcare professionals for individuals undergoing dental procedures.

DESCRIPTION

The ISORetract™ Mouth Retractor system is designed for dental procedures to retract the lips and cheeks away from the teeth, providing a clear view of the oral cavity. The tongue apparatus holds the tongue in place and features built-in suction slots that can connect to either a low or high-volume evacuator, helping to remove fluid/saliva in the mouth during dental procedures.

The system is easy to assemble and can be inserted and used by a single operator. The system is intended to be reusable. (See MAINTENANCE and STERILIZATION instructions).

INDICATIONS FOR USE

The ISORetract™ Mouth Retractor system is a saliva ejector mouthpiece intended for use by dental or orthodontic healthcare professionals during dental procedures. It is a dental accessory saliva ejector mouthpiece intended to remove saliva from the mouth through suction tubing and position patient’s lips and tongue to expose dental arches during dental and orthodontic procedures.

INSTRUCTIONS FOR USE

Read all instructions thoroughly before use.
COMPONENTS & ACCESSORIES

COMPONENTS & ACCESSORIES

Figure 3:

Component Identification Chart – A.1: Swivel Port; A.2: Cheek Retractor Notch; B.1: Retention Clip; B.2: C-shaped tube hooks; C.1: Tongue Housing Bracket; C.2: Occlusion Suction Bar; C.3: Barbed silicone tube port
ASSEMBLING THE ISORETRACT™ MOUTH RETRACTOR STEP 1

ASSEMBLING THE ISORETRACT™ MOUTH RETRACTOR INSTRUCTIONS

STEP 1.

Hold dental bar B in one hand and one Cheek retractor A in the other hand.

Connect the Retention Clip B.1 into the swivel port A.1 of the Cheek retractor A.

Rotate the cheek retractor A ¼ turn clockwise until it securely fastens.

Repeat with the second Cheek retractor component.

Figure 4: Diagram of Cheek retractor assembly.

INSERTION

Verify the suction tubing E is positioned on the silicone tube port C.3 as shown in Figure 5.

Bend the Cheek retractor/dental bar assembly and insert into patient’s mouth. Ask patient to form lips around retractor.

Position the tongue housing over tongue.

Slide tongue housing brackets C.1 into the cheek retractor notches A.2.

Instruct the patient to place his/her tongue into the tongue housing and relax the tongue. Once the patient is relaxed, the tongue housing will settle into the floor of the mouth.

Instruct the patient to rest teeth on the occlusion suction bar C.2 during use.

Guide the silicone tubes E through the C-shaped hooks B.2 as shown in Figure 5.

Connect the suction tubes to the Y-split adaptor F and attach to either a high or low-volume evacuator.

Turn on the suction evacuator. (You will hear oral suction begin)

Adjust as needed.

REMOVAL

Bring the Cheek retractors closer together and remove the entire system while still connected.

After removal, disconnect tongue housing from assembled to the cheek retractors. The Cheek retractors will eventually pull the tongue housing apart.

Disconnect silicone tubes from tongue housing.

Disconnect cheek retractors from dental bar.
ASSEMBLING THE ISORETRACT™ MOUTH RETRACTOR STEP 2

STEP 2.

Attach the silicone tubes E to the silicone tube port C.3.

Connect the two tongue housing brackets C.1 into the cheek retractor notches A.2.

Figure 5: Diagram of attaching tongue housing and silicone tubing.
INSERTION

INSERTION

Verify the suction tubing E is positioned on the silicone tube port C.3 as shown in Figure 5.

Bend the Cheek retractor/dental bar assembly and insert into patient’s mouth. Ask patient to form lips around retractor.

Position the tongue housing over tongue.

Slide tongue housing brackets C.1 into the cheek retractor notches A.2.

Instruct the patient to place his/her tongue into the tongue housing and relax the tongue. Once the patient is relaxed, the tongue housing will settle into the floor of the mouth.

Instruct the patient to rest teeth on the occlusion suction bar C.2 during use.

Guide the silicone tubes E through the C-shaped hooks B.2 as shown in Figure 5.

Connect the suction tubes to the Y-split adaptor F and attach to either a high or low-volume evacuator.

Turn on the suction evacuator. (You will hear oral suction begin)

Adjust as needed.

REMOVAL

Bring the Cheek retractors closer together and remove the entire system while still connected.

After removal, disconnect tongue housing from assembled to the cheek retractors. The Cheek retractors will eventually pull the tongue housing apart.

Disconnect silicone tubes from tongue housing.

Disconnect cheek retractors from dental bar.
WARNINGS AND PRECAUTIONS:

WARNINGS & PRECAUTIONS

This device is designed, intended, and distributed to be reusable. Follow the sterilization instructions to ensure proper sterilization techniques.

Proper bonding procedures and techniques are the responsibility of the dental professional. Described procedures are provided for informational purposes only. Each dental professional must determine the appropriate use of this device for each patient based on dental training, experience, the type of procedure employed, and the benefits and risks associated with device use.

Any use of this device, other than those indicated in these instructions, is not recommended.

The ISORetract™ Mouth Retractor has no user serviceable parts. DO NOT attempt to repair or alter the device.

The Cheek Retractor Notch may wear with regular use, causing the Tongue housing to slip. Replacement parts can be purchased at www.Isoretract.com

The ISORetract™ Mouth Retractor system is provided non-sterile. It must be sterilized prior to initial use and between uses. Please see STERILIZATION/ AUTOCLAVE instructions for detailed guidelines.

Proper cleaning is required prior to sterilization. Do not autoclave a visibly soiled device.

Do not use abrasive cleaners, bleach, or harsh chemicals.

Avoid arranging the ISORetract™ Mouth Retractor too close to other items in the autoclave, as this may prevent steam from reaching all surfaces.

Prevent contact with metal instruments that are in the autoclave.

Disconnect all component parts of the retractor system prior to sterilization to relieve spring tension on the tongue housing and allow steam to reach all surfaces during sterilization.

The cleaning process utilizes an enzymatic detergent (e.g., CIDEZYME® XTRA, or Micro-Scientific™) that has been validated by its manufacturer for use on polypropylene. Technical data sheets document and confirm that these detergents do not compromise the integrity or performance of polypropylene components. Copies of these documents are maintained in the device’s technical file.

Ensure proper sterilization by following the recommended autoclaving settings (typically 132ºC (270ºF) for 4 minutes or 121ºC (250ºF) for 30 minutes).

It is important to follow the sterilization guidelines provided by your autoclave manufacturer and ensure that the autoclave is properly calibrated for sterilization.
STERILIZATION – AUTOCLAVE INSTRUCTIONS

ULTRASONIC BATH PREPARATION

Rinse all parts under warm running water (30–40°C) for 30 seconds to remove visible debris.

Fill ultrasonic cleaner with distilled or purified water.

Add enzymatic detergent per the manufacturer’s recommended dilution instructions. Mix manually to ensure uniform solution-let sit for 1-2 minutes before use.

Fully submerge disassembled parts in the bath, shake for 15 min at 40-45ºC. Ensure no parts are touching or crowding each other.

Agitate gently if needed to ensure complete exposure.

Rinse thoroughly with purified water for at least 1-2 minutes to remove detergent residue, dry with lint-free towels.

STERILIZATION – AUTOCLAVE INSTRUCTIONS

Place disassembled dental bar, tongue housing, and cheek retractors in sterilization pouch.

Place silicone tube and Y-connector in separate pouch. Seal pouch properly.

Place sealed pouches in autoclave. Follow manufacturer’s instructions for autoclave settings. Autoclave at 121°C for 15-20 minutes for complete sterilization.

Allow all components to cool before handling.
CONTACT INFORMATION

CONTACT INFORMATION

ISORetract™, LLC

7533 S Center View Ct. # 5033 West Jordan, UT 84084

Phone: +1 (385) 545-7010

Web: isoretract.com

ISORetract is a registered trademark of ISORetract, LLC.
ISORetract products are protected by U.S. and foreign patents and patents
pending. Please direct any inquiries to ISORetract.