Chapter 10
Specifications
REF 1029568 Rev B
BiPAP Focus Ventilator Service Manual © Respironics, Inc.
10-9
10.6 Compliance
International Standards
• EN60601-1 1988
Medical Electrical Equipment Part 1: General Requirements for Safety
,
plus 1st and 2nd Amendments to the standard
• EN 60601-1-2 + A1:2000, Second Edition
Medical Electrical Equipment - Electromagnetic Compatibility
Requirements and Tests
• EN ISO 10651-6:2004
Lung Ventilators for Medical Use - Particular Requirements for Basic
Safety and Essential Performance
IEC 601-1 Classification
Class I, Type BF, internally powered, drip-proof equipment, continuous
operation.
WEEE/RoHS Recycling Directive
W
ASTE
E
LECTRICAL
AND
E
LECTRONIC
E
QUIPMENT
AND
R
ESTRICTION
OF
THE
U
SE
OF
C
ERTAIN
H
AZARDOUS
S
UBSTANCES
IN
E
LECTRICAL
AND
E
LECTRONIC
E
QUIPMENT
(WEEE/R
O
HS) R
ECYCLING
D
IRECTIVES
Compliant with the WEEE/RoHS recycling directives.
If you are subject to the WEEE/RoHS directives, refer to www.respironics.com
for the passport for recycling this product.
NOTE:
The backlight display includes a cold cathode fluorescent light (CCFL),
which contains mercury. Follow all applicable regulations for disposal.
Electromagnetic Emissions
WARNING: Using cables other than those supplied by Respironics may result
in increased emissions and/or decreased immunity of the BiPAP Focus
System.
Guidance and manufacturer’s declaration: electromagnetic emissions, IEC
60601-1-2 + A1:2000.
The BiPAP Focus System is suitable for use in the specified electromagnetic
environment. The customer and/or the user of the BiPAP Focus System should
ensure that it is used in an electromagnetic environment as described below:
Emissions Test/Compliance
Electromagnetic Environment
Guidance
RF emissions CISPR 11/Group 1
The BiPAP Focus System uses RF
energy only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
