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Product specifications
Displayed temperature range:
Operating ambient temperature range:
Storage temperature range:
Storage relative humidity:
Operating relative humidity:
Display resolution:
Accuracy for displayed temperature range
35 – 42 °C (95 – 107 .6 °F):
Outside this range:
Clinical repeatability:
Reference Body Site:
Battery life:
Service life:
Clinical accuracy characteristics and calibration procedures are available upon request .
This thermometer is specified to operate at a pressure of 1 atmosphere or at altitudes with an atmospheric
pressure up to 1 atmosphere . (700 - 1060 hPa) .
Type BF
Consult Instructions
Applied Part
for Use
Keep dry
Manufacturer
Subject to change without notice .
This appliance conforms to the following standards:
This infrared thermometer meets requirements established in ASTM Standard E 1965-98 as it pertains to
infrared thermometers . Full responsibility for the conformance of this product to the standard is assumed
by Kaz USA, Inc . 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) .
EN 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 .
EN IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance .
EN ISO 14971: Medical devices – Application of risk management to medical devices .
EN ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process .
EN IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests .
EN ISO 15223-1: Medical devices . Symbols to be used with medical device labels, labeling and information to
be supplied . General requirements .
EN 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 .
This product conforms to the provisions of the EC directive 93/42/EEC .
93 .2 – 108 °F
50 – 104 °F
-13 – 131 °F
Storage 15-95% RH (non-condensing)
Operating 10-95%
0 .1 °F or °C
Maximum Laboratory Error
±0 .4 °F
±0 .5 °F
±0 .26 °F
Oral Equivalent
2 years / 350 measurements
5 years
104 °F
131 °F
50 °F
-13 °F
(40 °C)
(55 °C)
(10 °C)
(-25 °C)
Operating
Storage
temperature
temperature
Date of
Attention, consult
Manufacture
Accompanying Documents
(34 – 42 .2 °C)
(10 – 40 °C)
(-25 – 55 °C)
(±0 .2 °C)
(±0 .3 °C)
(±0 .14 °C)
Storage relative
Operating relative
humidity
humidity
2
Hygienic lens filter:
Do not reuse
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