Regulations, Standards, And Codes; Device Classification - Dräger JM-103 Instructions Manual

available and can be affected by variables such as infant developmental
age, ethnicity, etc. Therefore, we recommend that the JM-103 be used in
conjunction with other clinical signs and laboratory measurements.
"Specific Bilirubin Measurement" should be confirmed by other
methods such as laboratory blood serum analysis.

Regulations, Standards, and Codes

In North America, with respect to electrical shock, fire, and mechanical
hazards only, this instrument complies with UL 60601-1 and CAN/CSA
C22.2 No. 601.1.
In Europe, this instrument complies with EN60601-1, EN60601-1-2,
and EN ISO13485, and EN ISO14971.
Directive 2002/96/EC of the European Parliament and of the Council of
2003-01-27 on Waste Electrical and Electronic Equipment (WEEE)
Annex IV, prEN 50419 applies.

Device Classification

The Jaundice Meter (JM-103) meets the requirements for the following
classifications:
• Protection against electrical shock: Internally powered
• Type of applied part: BF
• IPX0—ordinary equipment (Degree of protection against harmful
ingress of water: Not applicable.)
• Not suitable for use in the presence of flammable anesthetic mixture
with air or oxygen or nitrous oxide.
• Mode of operation of equipment: Continuous while in use (IEC
60601-1)
• Classification in accordance with EU Directive 93/42/EEC: IIa
• UMDNS code/GMDN code: 16-166/35475
Jaundice Meter Instructions for Use (MU01380)
DRAFT 20 June 2005
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