I
ntroductIon
Intended Use
The intended use of the UltraFill System is to provide supplemental oxygen to patients and to supply pressurized
oxygen to fill cylinders for the patients' personal ambulatory use. The device is not intended to be life supporting or
life sustaining.
Device Description
The UltraFill System is comprised of an oxygen filling station, a compatible oxygen concentrator, one or more oxygen
cylinder(s) and an oxygen conserving device or regulator.
While the UltraFill is filling a cylinder, a 5-liter concentrator will provide patient flow up to a maximum of 3 lpm and
fill the cylinder continuously. The UltraFill cannot be used with a 5-liter concentrator when the required patient flow
is greater than 3 lpm. When the required patient flow is greater than 3 lpm, the Millennium M10 concentrator will
provide flow up to a maximum of 7 lpm.
Warnings & Cautions
CAUTION: US federal law restricts this device to sale by or on the order of a physician.
Warnings
•
If while using the system you experience any discomfort or signs of any unusual physical symptoms, contact your
physician immediately.
•
Oxygen can promote rapid burning when exposed to an open flame. Do not allow any smoking objects or open
flames near this unit.
•
Do not use any oil, grease, or petroleum-based products on or near this unit.
•
Do not smoke while the device is in use.
•
Protect the device against the spillage of fluids on or around it. Do not place drinks on it. Do not allow fluids to
come in contact with the device. If fluids do come in contact with the device, contact your service representative.
•
Do not set any objects on, or allow to be draped over, the UltraFill Station as they might block air flow into the
device. Place the unit in a ventilated location with the sides and rear two feet away from any object.
•
Do not allow minors or children to operate the UltraFill System. Do not allow unsupervised children to play on
or near the device.
•
To prevent an accidental tip over, do not attempt to move the UltraFill when it is connected to a cylinder.
UltraFill User Manual
3