Instructions For Use PEDIA Anesthesia Balloons

Please Read All Descriptions, Indications and Warnings Before Use

DESCRIPTION

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.

Please Read All Descriptions, Indications and Warnings Before Use

Instructions for the anesthesia professionals:

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.
   1. Be sure the child seals their lips around the mouthpiece.
   1. 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.
   1. PIPs remain low
   1. 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.

Instructions: Pediatric Device for Induction of Anesthesia Please read all instructions before use.

WARNINGS:

Warnings:

	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

	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