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Humidity:
Battery:
Pressure:
Memory size:
The expected service life of the thermometer is 5 years .
If necessary, the circuit diagram and component list can be provided for
Authorized Technician Maintenance .
The BNT100US includes the following items: Sensian™ 4 Non-contact forehead
thermometer, 2 AAA batteries, owner's manual and quick reference guide .
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, Health & Home, 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:
IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
ASTM E1965-98: Standard Specification for Infrared Thermometers for
Intermittent Determination of Patient Temperature .
ISO 80601-2-56: Particular requirements for basic safety and essential
performance of clinical thermometers for body temperature measurement .
IEC 60601-1-2: Medical electrical equipment – Part 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 .
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 15223-1: Medical devices - Symbols to be used with medical device labels,
labeling and information to be supplied - Part 1: General requirements .
ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process
IEC 62304: Medical device software – Software lifecycle processes
ISO 14971: Medical devices - Application of risk management to medical
devices
12
15–95% non-condensing
(2) AAA Batteries - at least 500
measurements
700-1060 hPA (0 .7-1 .06 atm)
10
104 °F
59 °F
Type BF Applied Part
Operating temperature
131 °F
-13 °F
(55 °C)
(-25 °C)
Storage temperature
Consult Instructions for
Protected against solid foreign
Use
objects greater than 12.5 mm
in diameter and dripping water
95%
95%
15%
Operating humidity
Storage humidity
Caution: Read all warnings and
precautions in Instructions for
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 .
Remove the batteries from the instrument if not used it is not required for
extended periods of time in order to avoid damage to the thermometer
resulting from a leaking battery .
Please do not dispose of the product in the household waste at the end
of its useful life .
English
LOT
REF
Manufacturer
Model number
Lot number
SN
Serial number
Date of
manufacturer
when tilted at 15°
use
13

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Este manual también es adecuado para:

Bnt100