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English
IP22: Protected against solid foreign objects of 12.5 mm diameter and larger. Protected
against water drops falling vertically when the device is tilted up to 15°.
This infrared thermometer meets requirements established in ASTM Standard E 1965-98
(for the thermometer system). Full responsibility for the conformance of the product to the
standard is assumed by Kaz USA, Inc., a Helen of Troy Company, 400 Donald Lynch Blvd.,
Suite 300, Marlborough, MA 01752.
ASTM laboratory accuracy requirements in the display range of 37 to 39°C (98 to 102°F)
for IR thermometers is ±0.2°C (±0.4°F), whereas for mercury-in-glass and electronic
thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is ±0.1°C
(±0.2°F).
This device conforms to the following standards:
ASTM E1965-98 - Standard Specication for Infrared Thermometers for Intermittent
Determination of Patient Temperature.
ISO 80601-2-56 – Medical electrical equipment – Part 2-56: Particular requirements for basic
safety and essential performance of clinical thermometers for body temperature
measurement.
ANSI AAMI IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance.
IEC 60601-1-2 - Medical electrical equipment - Part1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic disturbances –
Requirements and tests.
NOTE: DO NOT use this device in the presence of electromagnetic or other interference
outside the normal range specied in IEC 60601-1-2.
IEC 60601-1-11 - Medical electrical equipment - Part 1-11: General requirements for basic
safety and essential performance -- Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment.
ISO 10993-1 - Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process.
ISO 15223-1 - Medical devices - Symbols to be used with medical device labels, labeling and
information to be supplied - Part 1: General requirements.
Internally Powered Equipment
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC.
For detailed description of EMC requirements please contact Consumer Relations.
Portable and mobile RF communications equipment can aect MEDICAL ELECTRICAL
EQUIPMENT.
+1
9°F
+1
3°F
Type BF Applied Part Consult Instructions
for Use
Operating temperature Storage/Transport
temperature
Caution
LOT SN REF MD
Authorized representative in
the European Community
Lot number Serial number Catalogue number Medical device
Manufacturer Date of manufacture Storage relative
humidity
Operating relative
humidity
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