Dräger Medical JM-103, Руководство по эксплуатации

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DRAFT 20 June 2005
Page 2 - 10 Jaundice Meter (Model JM-103) User Manual (usr070)
clinical data available. On average, 66% of results fall within this range,
and the remainder fall outside this range. This value can be affected by
variables such as age, skin color, and preformance of the device in the
hands of the user. Refer to Appendixes A and B for a detailed
description of results by clinical site, measurement location, and patient
demographics. The SEE shown above are based on the clinical data
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
• 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)