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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.
See Instructions for Use
-25°C
(-13°F)
+55°C
(131°F)
Storage /
Transport
Temperature
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°.
Type BF Applied Part
15°C
(59°F)
40°C
(104°F)
Operating
Temperature
Содержание BNT300CA
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