Oxygen Concentrator
6
Independent Safety Testing
Safety
IEC 60601-1 :1988 + A1 :1991 + A2 :1995 + Corrigendum (6/95)
EN 60601-1(1990) + A1(1993) + A2(1995) + A12(1993) + A13(1996) + Corrigenda (7/94)
Electromagnetic
Compatibility
FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN61000-3-2,
EN61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, IEC61000-4-5,
IEC61000-4-6, IEC61000-4-8, IEC61000-4-11, IEC 60601-1-2 :2001
The CAIRE Companion 5 is designed to comply with the following standards:
•
EN 60601-1-2—Electromagnetic Compatibility
•
IEC 60601-1—General Requirement for Basic Safety of Electrical Medical Equipment
•
ISO 8359—Oxygen Concentrators For Medical Use
•
ISO 13485—Medical Device Quality System
•
UL 60601-1 – General Requirement for Basic Safety of Electrical Medical Equipment
It is classified as Class 2 Medical Device by the United States Food and Drug Administration (FDA) and as a Class IIA device by
the European Medical Device Directive (MDD).
Provider Support Policy
Objective
: As a manufacturer our organizational goal is to provide customer support and assistance to the highest level of excellence
.
Customers
are Providers (which include Dealers, Distributors and Agents).
Support
includes, but is not limited to, troubleshooting and Return Material Authorizations (RMA).
Business Hours
are Monday – Friday, 8:30am – 5:00pm EST.
CAIRE Inc. can only support customers who are recognized as Providers, Dealers, Distributors and/or Agents.
These partnerships are qualified as having an existing account or are in the process of credit application completion. All patient or
end-user inquiries including but not limited to RMA, warranty or serial number questions must be handled by their Provider.
Provider Support Policy:
CAIRE Inc. is unable to provide direct assistance, clinical advice or recommendations to a patient or
end-user. Providers have sole responsibility in assisting their patients.
