LAS_500_eng
page 9
18. Safety:
•
DIN EN 60601-1:2001 + A1:2006
•
DIN EN 60601-1-2:1990 + A1:1993 + A2:1995 + A13:1996 (EMV)
•
2006/95/EG
•
California – Fire test Class 1 (for cover)
•
Bend-proof supply tubes
•
CPR – emergency valve
•
Acoustic power failure alarm
19. Testing for toxicological harmlessness
and Bio-compatibility
•
DIN EN ISO 10993-1:1998
•
ASTM F 963-96a
20. EMC
Electric devices may interact due to electro-magnetic radiation. We recommend
a safety distance of at least 1 meter distance especially for sensitive equipment.
Upon request we will provide you with a table for more detailed information
21. Maintenance / Inspection
The
novacare
LAS 500 low air loss therapy system
is a Medical product in
accordance with RL 93/42/EWG. Use and applications are subject to these legal
foundations.
Systems are suitable for reuse. However, hygiene directives must be observed and
flawless operation must be ensured.
Maintenance at regular intervals (mandatory every 2 years) is necessary to
preserve the function of the
novacare
LAS 500 low air loss therapy system.
Used filters must be exchanged within this period.
Maintenance / inspection is conducted by the producer or a firm authorized by the
producer at the client’s expense.
If maintenance / inspection is not conducted at all or in due time or not by an
authorized firm, then the guarantee or warranty claims are not longer valid.
Damages or any other loss of function arising from lack of maintenance or untimely
maintenance / inspection or interferences by an unauthorized party, likewise lead to
loss of guarantee and warranty claims (see warranty, paragraph 28).