Environmental Conditions; Symbol Legend - Bellus Medical SkinPen Precision Manual Del Usuario

14. ENVIRONMENTAL CONDITIONS

Operating conditions:
Transportation conditions:
The EMISSIONS characteristics of the SkinPen
suitable for use in industrial areas and hospitals (CISPR 11 class A).
This device complies with Industry Canada's license-exempt RSS. Operation
is subject to the following two conditions: (1) This device may not cause
interference; (2) This device must accept any interference, including interference
that may cause undesired operation of the device.
This user manual is valid for SkinPen Precision
Precision Charger Base (with AC adapter), SkinPen
SkinPen® Precision Treatment Kit.
Refer to the SkinPen Precision Instructions for Use for additional information on
®
the Procedure Instructions.
This user manual is published by Bellus Medical, LLC. Bellus Medical, LLC. Does
not guarantee its contents and reserves the right to improve and amend it at
any time without prior notice. Amendments will however be published in a new
edition of this manual.
Declaration of Conformity
Bellus Medical, LLC. Declares that the SkinPen
charger base complies with the following normative documents:
IEC 62133, IEC 60601-1, IEC 60601-1-2, IEC 62366, ISO 14971:2012,
IEC 62304, MDD 93/42/EEC, RoHS, IEC 60601-1-6, IEC 60529, ISO 10993-1.
This device complies with Part 15 of the FCC Rules.
We Bellus Medical, LLC. accept not having the ETL Mark on the SkinPen
Precision device label, but our product is 60601 certified.
Conforms to AAMI STD ES 60601-1, Certified to CSA STD C22.2 #60601-1.
16 PN#16130015 | Rev. C | International
Temperature: 17-30°C
Relative humidity: 30-75%
relative humidity non-condensing
Atmospheric Pressure: 70 -106 kPa
Temperature: -20-60°C
Relative humidity: 10-98%
relative humidity non-condensing
Precision & Charger Base make it
®
handpiece, the SkinPen
® ®
Precision BioSheath and
®
Precision and SkinPen Precision
® ®
®

SYMBOL LEGEND

Manufacturer's
trade name
and address
Serial Number
Authorized
Representative
in the European
Community
Do not re-sterilize
Sterilized using
ethylene oxide
Caution
Temperature
shipment limits
Keep dry
This device includes
RF transmitters
Positive Polarity
Manufacturer's
catalouge code
Batch code
CE mark (made in
compliance with
93/42EEC Directive
on class I medical
devices)
Do not re-use
Consult Instructions
for Use
Do not use if
package
is damaged
Humidity limitation
Not for
general waste
Direct Current
Use-by date
PN#16130015 | Rev. C | International 17