Symbol Explanations; Emc Declaration - HS AirMed 1000 Instrucciones De Uso

11.

Symbol Explanations

Consult 'Instructions for Use'
Caution
Manufacturer
Class II Equipment
Type BF applied parts
This product complies with the essential requirements of the medical
devices directive (93/42/EEC). Compliance has been verified by UK
notified body per 0120 (SGS United Kingdom Ltd).
Do not dispose of with household refuse
12.

EMC Declaration

With the increased number of electronic devices such as PCs and mobiles,
medical devices in use may be susceptible to electromagnetic interference from
these devices. Which may result in incorrect operation of the medical device
and create a potentially unsafe situation. Medical devices should also not
interfere with other devices.
In order to regulate the requirements for EMC with the aim to prevent unsafe
product situations, the EN60601-1-2 standard has been implemented. This
standard defines the levels of immunity to electromagnetic interferences as well
as maximum levels of electromagnetic emissions for medical devices.
Medical devices manufactured by Clement Clarke International Ltd conform to
this EN60601-1-2 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cables other than those specified by
Clement Clarke Int. Ltd, with the exception of cables sold by Clement Clarke
International Ltd. as replacement parts for internal components, may result
in increased emission or decreased immunity of the device.
• The medical devices should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is unavoidable, the medical device
should be seen to operate normally as it should in this situation.
Further guidance regarding the EMC environment (in accordance with
EN60601-1-2) in which the device should be used is available at
www.clement-clarke.com/medicalquality
en
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