Additional Guidelines; Storage And Transportation - KLS Martin smartPen MD 62 Gebrauchsanweisung

Peril to life or danger of serious physical injury from prion infection!
•
Destroy the smartPen immediately after potential contact with prions
(risk of CJD contamination!) and do not use it again under any circumstances!
The temperature in the autoclave must not exceed 138°C (280.4°F) and 18 min holding time, since
otherwise the insulation and other plastic parts might be damaged.
Steam sterilization with fractionated pre-vacuum
Minimum requirement
Maximum sterilization temperature
Maximum sterilization time
Drying time
Other times and temperatures can also be used as long as they are within the appropriate range.
The operator must ensure that sterility is maintained after the sterilization process.
Follow the handling and loading recommendations by the manufacturer of the sterilization device!
5.6.2

Additional Guidelines

Cleaning, care and sterilization instructions and other regulations are available in the Red Brochure entitled
"Proper Maintenance of Instruments", published by the AKI ("Arbeitskreis Instrumentenaufbereitung"–
Instrument Processing Working Group), which can be obtained from Gebrüder Martin GmbH & Co. KG upon
request. Useful information on instrument processing is also available via our website at:
http://kls-martin.com/phnet/.
5.7

Storage and Transportation

Information on minimum and maximum temperature for storage and transportation:
Designation
Environmental conditions for
storage and for transport
•
Store the smartPen in a clean, cool and dry place.
•
Protect smartPen against mechanical damage.
• When the variant smartPen REF 80-227-00-04 is used, unplug cable.
– Store cables in such a way that the insulation is protected against mechanical damage.
•
Store and transport the smartPen in safe containers or sterile packing. Use appropriate certified
sterilization containers, e.g. according to EN 868, ISO 11607.
54
3 min at 132°C (269.6°F)
138°C (280.4°F)
18 min
according to validation/program
Monopolar electrode handle smartPen
Ambient temperature
Relative humidity (no condensing moisture!)
Air pressure
Instructions for Use
Monopolar electrode handle smartPen
-20°C to +50°C (-4°F à +122°F)
10–75%
500–1,600 mbar
Revision 04