Regulations; Description Of Symbols - B.A. International Powersurge LED Manuel D'utilisation

26
E
w The use of this device must stay in the context of the operation for which it was designed.
w No changes, extensions and settings must be made by third parties or any other individual.
w Opening and repairs can only be carried out by individuals trained by
w Only
B.A. INTERNATIONAL
w The product must be used in accordance with the assembly, service and maintenance instructions..
w All the instructions contained in this document must be followed.

15. Regulations

According to ISO11498 and ISO7494 standards, the device is in the category of dental treatment devices.
This medical device is classed IIa as per the European directive 93/42/CE.
This equipment is manufactured in compliance with the following current standard IEC60601-1.
This equipment was designed and manufactured according to ISO 13485 quality assurance system.
As an electric and electronic equipment, the disposal of the product must be done by a specialised collection facility for the removal and
recycling or destruction (in particular in the European market, with reference to directive2002/96/CE dated January 23rd, 2003).
When the product becomes obsolete, we recommend you contact your supplier of dental equipment to determine the action to take.

16. Description of symbols

n
B
M
c
A
G
0476
NM05
f
g
X
Y
k
h
original replacement parts must be used.
Alternative voltage.
BF type device.
Attention : follow the instructions for use.
Class II device.
Manufacturer.
Class I or IIa medical device compliant with European directive 93/42CEE.
Gost certifi cation.
Thermodisinfectable device.
Sterilisation in an autoclave except for packaging.
Do not use if package is damaged.
Protect from light.
Authorised temperature limit.
Fragile.
and who have been accredited.
B.A. INTERNATIONAL