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
- This device is designed, intended, and distributed as a reusable medical device. Strictly follow sterilization instructions to ensure proper sterilization.
- Proper bonding procedures and techniques are the responsibility of the dental professional.
- The procedures described are for informational purposes only. Each dental professional must determine appropriate use based on training, experience, procedure type, and patient factors.
- Use only as indicated in these instructions. Any other use is not recommended.
- The device is one universal size, intended for adolescents and adults with adequate oral cavity dimensions. Not recommended for pediatric patients or those with limited mouth opening.
The ISORetract‚ Mouth Retractor has no user-serviceable parts. DO NOT attempt to repair or alter the device.
STERILIZATION – AUTOCLAVE INSTRUCTIONS
ULTRASONIC BATH PREPARATION
Rinse all parts under warm running water (30–40°C) for 30 seconds to remove visible debris.
Fully submerge disassembled parts in the bath, shake for 15 min at 40-45ºC. Ensure no parts are touching or crowding each other.
STERILIZATION – AUTOCLAVE INSTRUCTIONS
Disassemble the system and place each individual piece in a separate autoclave
sterilization pouch.
Seal each pouch securely, Pre-vacuum
cycle at 132ºC (270ºF) for 4 minutes, or Gravity cycle at 121ºC (250ºF) for 30 minutes,
followed by a 30-minute drying cycle.
Compliant with US FDA GMP (21 CFR Parts 210, 211, 820)
Sterilization validated per ANSI/AAMI/ISO 17665-1, ISO 17665:2024, and ANSI/AAMI/ISO 14937
Meets Sterility Assurance Level (SAL) requirements
Validated for pre-vacuum steam sterilization at 132°C, 4 minutes, 30-minute dry time
CONTACT INFORMATION
ISORetract™, LLC
7533 S Center View Ct. # 5033 West Jordan, UT 84084
Email: info@isoretract.com
Phone: 1-385-545-7010
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.
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