Certifications

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

•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.

UL 2601-1

CAN/CSA C22.2

NO.601.1

E 226863

IEC 60601-1

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.

i v Inv itium Operations M anual