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iv Invitium Operations Manual
European Union Declaration of Conformity for Medical Applications
A Declaration of Conformity exists for these products. To obtain a copy, contact Planar and
request the “Declaration of Conformity” document number below.
• Tk7 – 001-0014-04
• Tn4 – 001-0014-09
Certifications
• IEC/EN 60601-1:1990 + A1 + A2 for sale to the medical market
• IEC 60601-1-2:2001 as it applies to this system (informative data)
• Underwriters Laboratory to medical standards UL 2601-1 and CAN/CSA C22.2
No. 601.1 M1990 for sale in the United States and Canada
• Carries the CE mark for sale in the European Community
Symbol Explanations
This information identifies and describes the symbols found on the Invitium.
Proof of conformity to applicable European Economic Community
Council directives and harmonized standards published in the
official journal of the European Communities.
Product is certified with respect to electric shock, fire, mechanical
and other hazards only in accordance with US 2601-1 and
CAN/CSA C22.2 No. 601.1 and IEC 60601-1 for medical
equipment. If this mark appears with the indicators
C and US, the product is certified for the United States and
Canadian markets, meeting the applicable United States and
Canadian standards.
Tested to comply with FCC Class B standards.
Consult accompanying documents.
Indoor use only.
E 226863
UL 2601-1
CAN/CSA C22.2
NO.601.1
IEC 60601-1