Helmer iBX020, Руководство по техническому обслуживанию

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General Information
3 Compliance
3 .1 Regulatory Compliance
Pollution degree: 2 (for use in USA and Canada only)
This product is certified to applicable UL and CSA standards by a NRTL.
This device complies with the requirements of directive 93/42/EEC concerning
Medical Devices, as amended by 2007/47/EC.
Sound level is less than 70 dB(A).
EC
REP
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
3 .2 WEEE Compliance
The WEEE (waste electrical and electronic equipment) symbol (right) indicates compliance
with European Union Directive WEEE 2012/19/EU and applicable provisions. The directive
sets requirements for the labeling and disposal of certain products in affected countries.
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
3 .3 Electromagnetic Compliance
This device is suitable for use in a specific electromagnetic environment. The end user of this device is
responsible for ensuring the device is used in compliance with the following European Union directives and
standards regarding EMC (electromagnetic compliance):
EMC Directive 2004/108/EC
► EN 55011:2015 ► EN 61000-3-3:2013
► EN 61000-3-2:2014 ► EN 61326-1:2013
3 .4 Manufacturer
Helmer Scientific is the manufacturer as defined in 93/42/MDD of the iBX020 and for which the CE mark on the
cover of this manual applies.
Haemonetics Corporation is the manufacturer as defined in 93/42/MDD of the BloodTrack Courier
®
software and
maintains sole responsibility for placing the HaemoBank™ in its final configuration on the market.