System Overview
System Symbols
User Manual
17
8.
Burns JA, Allison J, Bachelor E, Dover J, Coleman S, Fitzpatrick R, Garden J, Geronemus R, Goldberg D,
Kilmer S, Kramer S, Levinson M, Mayoral F, Okamoto E, Tanzi E, Riopelle J, Weiss R, Zelickson B.
Analysis of Side Effects of Non-Invasive Cryolipolysis for Subcutaneous Fat Layer Reduction
–
Interim
Report from Controlled Clinical Trials. Lasers Surg Med. 2010; 42(S22):21.
9.
Dover J, Burns J, Coleman S, Fitzpatrick R, Garden J, Goldberg D, Geronemus R, Kilmer S, Mayoral F,
Tanzi E, Weiss R, Zelickson B. A Prospective Clinical Study of Noninvasive Cryolipolysis for
Subcutaneous Fat Layer Reduction
–
Interim Report of Available Subject Data. Lasers Surg Med. 2009;
41(S21):43.
10.
Kaminer M, Weiss R, Newman J, Allison J. Visible Cosmetic Improvement with Cryolipolysis:
Photographic Evidence. Presented at the Annual Meeting of the American Society for Dermatologic
Surgery, 2009, Phoenix, AZ.
ZELTIQ Customer Service
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Worldwide: (+1) 925-474-8160
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U.S.A.: 1-888-935-8471 (1-888-ZELTIQ1)
System Symbols
The following symbols are used on the components of the system and on its supplies and packaging.
Manufacturer
Indicates the medical device manufacturer, as
defined in EU Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
Per ISO 15223-1
Reg. No. 3082
Authorized Representative in the European
Community
Indicates the Authorized representative in the
European Community.
Per ISO 15223-1
Refer to instruction manual/booklet
To signify that the instruction manual/booklet
must be read.
Per IEC 60878
Reg. No. M002
Consult instructions for use (user manual,
directions for use)
Indicates the need for the user to consult the
instructions for use.
Per ISO 15223-1
Reg. No. 1641
Conformité Européene or European
Conformity
Indicates manufacturer declaration that the
product complies with the essential
requirements of the relevant European
health, safety and environmental protection
legislation.
Article 17
Caution
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
that cannot, for a variety of reasons, be
presented on the medical device itself.
Per ISO 15223-1
Reg. No. 0434A
Do not reuse
Indicates a medical device that is intended for
one-time use only.
Per ISO 15223-1
Reg. No. 1051
Do not use if package is damaged
Indicates a medical device that should not be
used if the package has been damaged or
opened.
Per ISO 15223-1
Reg. No. 2606
Type BF applied part
To identify a type BF applied part complying
with IEC 60601-1.
Per IEC 60417
Reg. No. 5333
Potential for Electromagnetic Interference
Per IEC 60417
Reg. No. W005
