3M ESPE Elipar DeepCure-L, Руководство по эксплуатации

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SEITE 13 - 148 x 210 mm - 3100021788/01 - SCHWARZ - 20-052 (kn)
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Symbol Glossary
Information valid as of January 2020
Reference Num-
ber and Symbol
Title Symbol Description of Symbol
ISO 15223-1
5.1.1
Manufacturer Indicates the medical device
manufacturer as defined in EU
Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
ISO 15223-1
5.1.3
Date of Manufacture Indicates the date when the
medical device was manufac-
tured.
ISO 15223-1
5.1.5
Batch code Indicates the manufacturer's
batch code so that the batch or
lot can be identified.
ISO 15223-1
5.1.6
Catalogue number Indicates the manufacturer's
catalogue number so that the
medical device can be identified.
ISO 15223-1
5.1.7
Serial number Indicates the manufacturer's se-
rial number so that a specific
medical device can be identified.
ISO 15223-1
5.3.7
Temperature limit Indicates the temperature limits
to which the medical device can
be safely exposed.
ISO 15223-1
5.3.8
Humidity limitation Indicates the range of humidity
to which the medical device can
be safely exposed.
ISO 15223-1
5.3.9
Atmospheric
pressure limitation Indicates the range of atmos-
pheric pressure to which the
medical device can be safely
exposed.
ISO 15223-1
5.4.4
Caution Indicates the need for the user to
consult the instructions for use
for important cautionary informa-
tion such as warnings and pre-
cautions that cannot, for a variety
of reasons, be presented on the
medical device itself.
CE Mark Indicates conformity to European
Union Medical Device Regulation
or Directive.
Medical Device Indicates the item is a medical
device.
Follow instructions
for use To signify that the instructions
for use must be followed.
Rx Only Indicates that U.S. Federal Law
restricts this device to sale by or
on the order of a dental profes-
sional. 21 Code of Federal Regu-
lations (CFR) sec. 801.109(b)(1).
Reference Num-
ber and Symbol
Title Symbol Description of Symbol
Type B applied part To identify a type B applied part
complying with IEC 60601-1.
Class II equipment To identify equipment meeting
the safety requirements for Class
II equipment per IEC 61140.
Use Indoors Indicates medical device be used
indoors
Regulatory
Compliance Mark Indicates product complies with
applicable Australian regulatory
requirements.
Battery Battery power level
PAP 20/21 Indicates paper material is
recyclable.
Recycle electronic
equipment DO NOT throw this unit into a
municipal trash bin when this
unit has reached the end of its
lifetime. Please recycle.
Green Dot Indicates a financial contribution
to national packaging recovery
company per European Directive
No. 94/62 and corresponding
national law. Packaging Recov-
ery Organization Europe.