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- The electrical fittings in the room comply with all regulatory
requirements;
- The unit is operated according to these Operating Instructions.
Plastic cartridges are subject to wear depending on the material and
frequency of use and are therefore not covered by the warranty for this
unit. They should be regularly checked for signs of wear (e.g., fissures)
and replaced with new Penta cartridges for Pentamix Lite two years after
initial operation at the very latest. The use of worn or defective cartridges
can have adverse effects on the evenness of the mixture, reducing the
quality of the impression.
8. Customer Information
No person is authorized to provide any information that deviates from the
information provided in this instruction sheet.
8.1 Warranty
3M Deutschland GmbH warrants this product to be free from defects
in material and manufacture. 3M Deutschland GmbH MAKES NO
OTHER WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. User is
responsible for determining the suitability of the product for user's
application. If this product is defective within the warranty period, your
exclusive remedy and 3M Deutschland GmbH's sole obligation shall be
repair or replacement of the 3M Deutschland GmbH product.
8.2 Limitation of Liability
Except where prohibited by law, 3M Deutschland GmbH will not be liable
for any loss or damage arising from this product, whether direct, indirect,
special, incidental or consequential, regardless of the theory asserted,
including warranty, contract, negligence or strict liability.
Symbol Glossary
Reference Num-
Symbol
Description of Symbol
ber and Symbol
Title
ISO 15223-1
Indicates the medical device manufacturer as defined
5.1.1
in EU Directives 90/385/EEC, 93/42/EEC and
Manufacturer
98/79/EC.
ISO 15223-1
Indicates the date when the medical device was man-
5.1.3
ufactured.
Date of Manufacture
ISO 15223-1
Indicates the manufacturer's batch code so that the
5.1.5
batch or lot can be identified.
Batch code
ISO 15223-1
Indicates the manufacturer's catalogue number so
5.1.6
that the medical device can be identified.
Catalogue number
ISO 15223-1
Indicates the manufacturer's serial number so that a
5.1.7
specific medical device can be identified.
Serial number
ISO 15223-1
Indicates a medical device that can be broken or dam-
5.3.1
aged if not handled carefully.
Fragile, handle with
care
ISO 15223-1
Indicates a medical device that needs to be protected
5.3.4
from moisture.
Keep dry
ISO 15223-1
Indicates a medical device that is intended for one use
5.4.2
or for use on a single patient during a single proce-
Do not re-use
dure.
ISO 15223-1
Indicates the need for the user to consult the instruc-
5.4.4
tions for use for important cautionary information such
Caution
as warnings and precautions that cannot, for a variety
of reasons, be presented on the medical device itself.
ISO 7000-0623
Indicates to orientation to store and handle product.
This way up
CE Mark
Indicates conformity to European Union Medical De-
vice Regulation or Directive.
Medical Device
Indicates the item is a medical device.
Rx Only
Indicates that U.S. Federal Law restricts this device to
sale by or on the order of a dental professional. 21
Code of Federal Regulations (CFR) sec. 801.109(b)(1).
PAP 20
Indicates paper material is recyclable.
Low-density poly-
Indicates plastic component made of low-density poly-
ethylene
ethylene is recyclable.
Recycle electronic
DO NOT throw this unit into a municipal trash bin
equipment
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 Recovery
Organization Europe.
Information valid as of June 2020
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