PeDIA Mission
To create a New Paradigm for pediatric induction of anesthesia.
Mailing Address
PeDIA LLC
3057 Nutley St, Suite 594
Fairfax, Virginia 22031
Phone | Email
703-966-9578
contact@pediallc.com

Instructions: Pediatric Device for Induction of Anesthesia Please read all instructions before use. PeDIA The Pediatric Device for Induction of Anesthesia (PeDIA) is a single-use, disposable, mask-free anesthetic delivery system and method used for children 3 years and older. The devices come individually packed and are not meant to be sold separately. Simply tear the individual plastic wrap and the PeDIA Balloon is ready to use. Consult instructions for use Single use; disposable Keep dry Caution No components of the PeDIA are made of latex Disposables delivered are non-sterile DO NOT send any portion of the device home with the child DO NOT use if the device is damaged DO NOT use if the packaging is damaged DO NOT use with combustible volatile anesthetics DO NOT sterilize the device DO NOT reuse the device or share between patients DO NOT separate the body of the device from the mouthpiece DO NOT use with children who cannot or will not follow directions Indications: The pediatric device for induction of anesthesia (PeDIA) is an alternative to a face mask for the inhalation induction of anesthesia and is intended for the delivery of nitrous and/or anesthetic gases to children age three years and older. It is intended to be used prior to IV insertion, LMA/endotracheal intubation, and/or conversion to a standard mask induction Restricted to sale by or on the order of a physician Manufacturer of Record Date of manufactured unit Catalog Number Lot Number Do not use if packaging is open or damaged Do perform an anesthesia machine check per ASA guidelines to include the scavenger system Do instruct the child on the proper use of the device Do inspect the device for signs of damage Do set and maintain the Adjustable Pressure Limiting Valve (APL or pop-off) to minimum Discontinue use with signs of increased pressure within the PeDIA such as: − A taut balloon or increase Peak Inspiratory Pressures (PIP). − Any signs of patient distress − The patient cannot or will not follow directions U001revF Page 1 of 2 Instructions: Pediatric Device for Induction of Anesthesia Please read all instructions before use. Mouthpiece (whistle) used by patient to inhale and exhale gases Balloon fills with anesthetic gases Universal connector attaches to anesthesia breathing circuit Instructions for the anesthesia professional: 1. Attach the universal connector of the PeDIA to the anesthesia breathing circuit as you would the anesthesia mask. 2. Turn the APL valve (pop-off) to minimum. 3. Obstruct the whistle/mouthpiece using your thumb/finger to trap gases inside balloon. 4. Turn up flows of oxygen and nitrous oxide sufficient to inflate the PeDIA. 5. Hand the child the inflated PeDIA Balloon. a. Be sure the child seals their lips around the mouthpiece. b. Be sure child inhales and exhales only through the mouth, not the nose. 6. As the child exhales and inhales, observe the system is working properly. a. PIPs remain low b. Balloon slightly inflates and deflates. 7. After 2-3 breaths, dial-in the volatile anesthetic of choice.* 8. When the child falls asleep or is too sleepy to hold a proper seal lips around whistle, take the PeDIA from the child and lay the child supine. 9. Detach PeDIA from the anesthesia circuit using a gentle pull. 10. Attach the anesthesia mask to the breathing circuit.** 11. Support patient respiration with mask-ventilation and continue induction/intubation. 12. Discard the PeDIA per facility protocol. *Noncombustible anesthetic agents should be used with gas flows and anesthetic concentrations determined by the anesthesia provider. **Before switching to a mask, the practitioner may elect to vent the gases into the circuit. U001revF Page 2 of 2