Instructions for Use

Document: 107-000500e

Indications for Use

AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen delivery and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. It is not indicated for sue during procedures that are expected to require deep sedation.

Device Description

AIM is a non-sterile, single-use, disposable intraoral device that combines three functions:

  • Bite block to maintain oral opening and provide airway access
  • Oxygen delivery channel directed to the oropharynx
  • CO2 sampling port for connection to capnography monitoring equipment

Instructions

Device Preparation

1. Evaluate AIM for damage or defects. Defective devices should not be used.

2. Attach oxygen supply tube to oxygen source and luer connector to CO2 monitor.

3. Ensure oxygen is flowing through the device before use on patient.

To Insert

4. Insert the bite block into either the right or left side of the patient's mouth. If used in lateral position, AIM should be placed on the top side of patient.

5. Seat the biting surface against the lower molars or pre-molars (See B and C).

6. Check the position of the bite block and adjust as required.

7. Check Capnography. If no waveform is present, ask patient to breathe through the mouth. Ensure baseline capnography before administering sedatives or narcotics to the patient.

8. Secure AIM with tape (See D).

During Use

- If capnography waveform is lost during the procedure:

a. Evaluate for apnea or airway obstruction.

b. If patient is breathing and oxygen saturation is adequate, begin using a secondary capnography device (e.g. sampling nasal cannula).

c. Continue oxygen delivery via AIM while sampling via the second capnography method.

- If AIM is dislodged during use, reposition as needed.

To Remove

9. Remove the tape securing AIM.

10. Slide the bite block out using atraumatic technique.

Warning

    AIM is not intended for use in procedures requiring deep sedation. Only use AIM as directed for procedures involving minimal or moderate sedation in patients 18 years and older

CAUTION

  • Do not use AIM as a lever to pry open a patient's mouth
  • Do not use in edentulous patients or those with signs of altered oral anatomy
  • Use of sterilization or cleaning solutions may leave this device nonfunctional
  • O2 flow greater than 8LPM may cause CO2 washout that underestimates EtCO2 values
  • AIM should be used for less than 24 hours
  • AIM is not recommended for use in the prone position

Storage

Store in a clean, dry environment at room temperature. Protect from direct sunlight and extreme temperatures. See packaging for expiration date.

Download

Download the complete Instructions for Use.

Download IFU (PDF)

Questions?

Contact us at info@macmodule.com for technical support or additional information.