biodex ATOMLAB 960 - Product Certifications and Classifications; Regulatory Compliance and Certifications

X ATOMLAB 960 MEDICAL SPECTROMETER
Product Certifications and Classifications
The Atomlab 960 Thyroid Uptake System has received the following certifications, and falls
within the following classifications:
• ETL Listed Electrical Equipment, Laboratory Use; Part 1, General Requirements for Safety
conforms to IEC 60601-1-6, IEC 60601-1-6 2
nd
Ed, ANSI 60601-1 3
rd
Ed,
IEC 60601-1 3
rd
Ed, IEC 60601-1 2
nd
Ed, IEC 60601-1-4 (2000), IEC 60601-1-6 3
rd
Ed
IEC 60601-1-2: UL 60601-1 (2003) 2
nd
Ed, and IEC 60601-1-1 and CE Marked.
• FDA Class II Equipment
• EC Certificate: EC # 41313009
• Type B Applied Part
• Electromagnetic Compatibility: This equipment complies with the Medical Equipment
IEC60601-2: 2007 EMC Standard.
NOTE: Circuit diagrams for this product are provided in the Schematics section at the back
of this manual.
Authorized European Community Representative:
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands