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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, Marlborough, MA 01752, USA.
ASTM laboratory accuracy requirements for the thermometer only in the display range of
96.8 °F to 102.2 °F (36 °C to 39 °C) for infrared thermometers is ± 0.4 °F (± 0.2 °C), whereas for
mercury-in-glass and electronic thermometers, the requirement per ASTM Standards
E 667-86 and E 1112-86 is ± 0.2 °F ( ± 0.1 °C).
This device conforms to the following standards:
IEC 60601-1: Medical electrical equipment. General requirements for basic safety and
essential performance
ISO 80601-2-56: Particular requirements for basic safety and essential performance of clinical
thermometers for body temperature measurement
ASTM E1965-98: Standard specification for infrared thermometers for intermittent
determination of patient temperature.
IEC 60601-1-2: Medical electrical equipment-Part 1-2: General requirements for basic 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 specified in IEC 60601-1-2.
ISO 15223-1: Medical device-symbols to be used with medical device labels, labelling and
information to be supplied-Part 1: General Requirements
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.
Type BF
Consult Instructions
Applied Part
for Use
Manufacturer
Date of
Manufacture
IP22: Protected against solid foreign objects greater than 12.5 mm in diameter and dripping
water when tilted at 15°.
Internally Powered ME Equipment
Continuous Operation
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 affect MEDICAL ELECTRICAL EQUIPMENT.
14
104 °F
50 °F
(40 °C)
(10 °C)
Operating
temperature
Storage relative
Operating relative
humidity
humidity
55 °C
-25 °C
(131 °F)
(-13 °F)
Storage
Attention, consult
temperature
Accompanying Documents
Catalog
Number
Lot
Serial
Number
Number
Publicidad
