14
Standards and warnings
14.1
Definition of symbols
MADSEN Zodiac
Complies with Type BF requirements of IEC60601-1.
Follow instructions for use.
Consult user manual for warnings and cautions.
Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).
Complies with the Radio Equipment and Telecommunications Terminal Equipment Directive 1999/5/EC.
MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accord-
ance with UL 60601-1, first edition, 2003 CAN/CSA-22.2 No. 601.1-M90.
OR
MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accord-
ance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), IEC 60601-1-6, CAN/CSA-C22.2 No. 60601-1
(2014) and CAN/CSA-C22.2 No. 60601-1-6 (2011).
In France, it is only permitted to use the device indoors.
This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:
•
This device must not cause harmful interference.
•
This device must accept any interference received, including interference that may cause undesired
operation.
The term”IC” before the certification/registration number signifies that the Industry Canada technical spe-
cifications were met.
Electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment
(WEEE).
All electrical and electronic products, batteries, and accumulators must be taken to separate collection at
the end of their working life. This requirement applies in the European Union. Do not dispose of these
products as unsorted municipal waste.
You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also con-
tact your local authorities for advice on disposal.
37
User Guide
Otometrics - MADSEN Zodiac
