ENGLISH
MD 950
/ NanoPak
Introduction
Chapter 1
Page GB 4
9.694.038
V 4.02
1 Introduction
1.1 Preface
First of all we would like to thank you for purchasing this sealing device.
In these instructions you will find information about using the device, servicing and care as well
as process validation.
The sealing device is a microprocessor controlled rotary sealer with a printer for packaging
sealable transparent pouches and reels (SBS = sterile barrier system).
The sealing device meets the requirements of DIN 58953-7, DIN EN ISO 11607-2 and the
resulting DGSV (German Society for Sterile Supply) guideline for validating the sealing
process.
Always keep these instructions close to the device.
1.2 Important notice
In accordance with the intended use, the CE marking is displayed based on
the following EU directives:
2006/42/EC, 2014/30/EU and 2011/65/EU.
Medical device directive 93/42/EEC is not applicable to sealing devices.
The limit values of IEC 60601-1 must not be applied in repeated electrical
inspections.
The manufacturer accepts no liability whatsoever for damage caused by tests
in accordance with standards not listed in the declaration of conformity.
Please read these operating instructions carefully before commissioning so that
you are familiar with the capabilities of the device and you can make optimum use
of its functions.
Note
We are constantly improving our products, therefore we
reserve the right to modify these operating instructions
and the functions described in them.
These operating instructions apply to products from
software version V4.02.00 onwards
