|7625 West New York Street|
|Indianapolis, Indiana 46214-4911 USA|
|Telephone: (317) 273-6960|
|Facsimile: (317) 273-6979|
|Order Desk Telephone: (800) 401-1723|
|Order Desk Facsimile: (800) 515-9254|
not replace factory installed dynamic seals on any Flotec Oxygen Regulators
with any non-Flotec washers or seals.
When the factory installed Soft Seat Yoke Washer Seal is removed and replaced with a hard non-elastomeric washer, the FDA Class I medical device (MMD directive Class IIb) has been altered without the permission of Flotec. This alteration is not endorsed under the FDA’s CGMP, ISO9001:2000, or ISO13485:2003.
In addition to the hazard of ignition of the seal, this modification of the regulator constitutes what the FDA describes as an “adulteration”. This alteration exposes the buyer to liability should ignition occur. The solution is “Do not replace Flotec factory-installed seals with any non-factory replacement parts.”
transfillers provide hard washers with each full cylinder.
When the new cylinder is put into service these hard washers are often
used in place of Flotec’s Soft Seat Yoke Washer Seal.
Because these hard washers are not elastomeric it takes a great deal of
extra torque on the T-Handle and the Dome Handle to achieve a proper
high-pressure seal. The force required to effect a high-pressure seal with the
hard washers is so great that many people use a wrench to force the T-Handle
tight. This over-torquing of the
T-handle often damages the screw threads and bends the crossbar of the T-Handle.
There are numerous reports of ignition and burning of the hard washer
seal when a proper high-pressure seal was NOT achieved.
The use of non-original
equipment seals on Flotec yoke style (CGA 870) oxygen regulators are not
approved by Flotec and Voids the Warranty.
Washer Seal (draft).doc(10-14-03)