Warranty; Technical Information - Novo Nordisk NovoPen 6 User Manual

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Warranty

NovoPen® 6 comes with a 3-year guarantee,
which also includes the dose memory.
If you find that your NovoPen® 6 is faulty,
Novo Nordisk will replace it. Return it to your
supplier for inspection within three years of
receiving it. Enclose the receipt you were given
when you received your NovoPen® 6.
For customers in the European Union; if, in the
course of use of NovoPen® 6, you have reason
to believe that a serious incident occurred,
please report it to Novo Nordisk A/S and to your
national authority.
The manufacturer cannot be held responsible for
any problems with your NovoPen® 6 if the
instructions have not been followed.
If you find that the information provided in this
user guide is incorrect, contact your supplier to
clarify the issue.
If you need your pen's LOT number, you will find
it on the dose button as shown in the diagram
on the inside cover.
NovoPen®, Penfill®, NovoFine® and NovoTwist®
are registered trademarks owned by
Novo Nordisk A/S, Denmark.
The N Mark is a trademark or registered
trademark of NFC Forum, Inc. in the United
States and in other countries.

Technical information

The CE mark on a medical device indicates that
the product conforms with the provisions in the
EC Directive for Medical Devices 93/42/EEC.
Novo Nordisk A/S, hereby declares that the radio
equipment type NovoPen® 6 is in compliance
with Directive 2014/53/EU. The full text of the
EU declaration of conformity is available at the
following internet address: http://bit.ly/NovoPen6
NovoPen® 6 fulfils the specification limits for
dose accuracy (essential performance) according
to ISO 11608-1 Pen-Injectors for Medical use,
Part 1: Requirements and test methods.
Storage and operational conditions
– Without an insulin cartridge inserted:
Temperature: 5 °C to 40 °C
Humidity: 15% RH to 93% RH
Atmosphere: 700 hPa to 1060 hPa.
– With an insulin cartridge inserted:
See the instructions in the Penfill® cartridge
3 ml leaflet that comes with the Penfill®
cartridge 3 ml package.
Mode of operation
Continuous Operation.

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