Provider Support Policy - CAIRE Companion 5 Provider Technical Manual

Independent Safety Testing
IEC 60601-1 :1988 + A1 :1991 + A2 :1995 + Corrigendum (6/95)
Safety
EN 60601-1(1990) + A1(1993) + A2(1995) + A12(1993) + A13(1996) + Corrigenda (7/94)
FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN61000-3-2,
Electromagnetic
EN61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, IEC61000-4-5,
Compatibility
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.
Oxygen Concentrator
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