Helmer Scientific i.Series
®
Platelet Incubator
Operation Manual
360388/A
16
7 Compliance
7.1
Safety Compliance
This device complies with the requirements of directive 93/42/EEC concerning Medical Devices, as amended
by 2007/47/EC.
This product is certified to applicable UL and CSA standards by a NRTL.
This product is IECEE CB Scheme certified and complies with national differences for safety certification beyond
IEC 61010-1-12 3rd edition.
7.2
Environmental Compliance
This device complies with the 2011/65/EU Directive for the Restriction of Hazardous Substances (RoHS).
This device falls under the scope of Directive 2102/19/EU Waste Electrical and Electronic Equipment (WEEE) .
When disposing of this product in countries affected by this directive:
♦
Do not dispose of this product as unsorted municipal waste.
♦
Collect this product separately.
♦
Use the collection and return systems available locally.
For more information on the return, recovery, or recycling of this product, contact your local distributor.
7.3
Electromagnetic Compliance
Helmer Scientific Incubators meet the applicable requirements of IEC61326 and EN55011 and are intended for use in the
electromagnetic environment specified in 6.1 Operating Standards. The customer or the user of these devices should assure they
are used in such environment.
This device complies with FCC Radiated and Conducted Emissions Approval to CFR47, Part 15; Class A levels
Helmer Scientific
14400 Bergen Blvd.
Noblesville, Indiana 46060 USA
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
0086
EC REP
