SEITE 13 - 148 x 210 mm - 3100021789/01 - SCHWARZ - 20-053 (kn)
Symbol Glossary
Reference Num-
Symbol
ber and Symbol
Title
ISO 15223-1
5.1.1
Manufacturer
ISO 15223-1
5.1.3
Date of Manufacture
ISO 15223-1
5.1.5
Batch code
ISO 15223-1
5.1.6
Catalogue number
ISO 15223-1
5.1.7
Serial number
ISO 15223-1
5.3.7
Temperature limit
ISO 15223-1
5.3.8
Humidity limitation
ISO 15223-1
5.3.9
Atmospheric
pressure limitation
ISO 15223-1
5.4.4
Caution
CE Mark
Medical Device
Follow instructions
for use
Rx Only
Description of Symbol
Indicates the medical device
manufacturer as defined in EU
Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
Indicates the date when the
medical device was manufac-
tured.
Indicates the manufacturer's
batch code so that the batch or
lot can be identified.
Indicates the manufacturer's
catalogue number so that the
medical device can be identified.
Indicates the manufacturer's se-
rial number so that a specific
medical device can be identified.
Indicates the temperature limits
to which the medical device can
be safely exposed.
Indicates the range of humidity
to which the medical device can
be safely exposed.
Indicates the range of atmos-
pheric pressure to which the
medical device can be safely
exposed.
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.
Indicates conformity to European
Union Medical Device Regulation
or Directive.
Indicates the item is a medical
device.
To signify that the instructions
for use must be followed.
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-
Symbol
ber and Symbol
Title
Type B applied part
Class II equipment
Use Indoors
Regulatory
Compliance Mark
Battery
PAP 20/21
Recycle electronic
equipment
Green Dot
Information valid as of January 2020
Description of Symbol
To identify a type B applied part
complying with IEC 60601-1.
To identify equipment meeting
the safety requirements for Class
II equipment per IEC 61140.
Indicates medical device be used
indoors
Indicates product complies with
applicable Australian regulatory
requirements.
Battery power level
Indicates paper material is
recyclable.
DO NOT throw this unit into a
municipal trash bin when this
unit has reached the end of its
lifetime. Please recycle.
Indicates a financial contribution
to national packaging recovery
company per European Directive
No. 94/62 and corresponding
national law. Packaging Recov-
ery Organization Europe.
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