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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 - General requirements for basic safety and essential performance – Collateral
Standard: Electromagnetic disturbances – Requirement 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 devices - Symbols to be used with medical device labels, labeling
and information to be supplied - Part 1: General requirements.
EN 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.
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°.
104 °F
50 °F
(40 °C)
(10 °C)
40 °C
10 °C
-25 °C
(104 °F)
(50 °F)
(-13 °F)
Operating
temperature
temperature
Storage relative
Operating relative
humidity
humidity
55 °C
(131 °F)
Storage
Attention, consult
Accompanying Documents
English
Catalog
Number
Lot
Serial
Number
Number
13
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