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,
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.
5 .
,
,
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: ,
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: 32,0 °C – 42,9 °C (89,6 °F – 109,2 °F)
: 10 – 40 °C (50 – 104 °F)
15%~95%
: 0,1 °C °F
35,5 °C – 42 °C (95,9 °F – 107,6 °F): ± 0,1 °C (± 0,2 °F) 23±5°C
: ±0,2 °C/0,4 °F ( 32,0 °C – 42,9 °C (89,6 °F – 109,2 °F))
: 1xCR1632, 3
: 500 2
: 2000
/
-25 – 55 °C ± 2 °C 15-95% . . ± 5%
:
.
BF .
.
.
.
.
IP22: 12,5
15 .
,
(760–1060 ).
BF.
.
:
, , , EN 12470-3: 2003 Clinical thermometers – Part 3: Performance of
compact electrical thermometers (non-predictive and predictive) with maximum device. (
. 3.
( )
.)
EN 60601-1: 2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance. ( . 1.
.)
EN ISO 14971: 2012 Medical devices – Application of risk management to medical devices. (
. .)
EN ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Evaluation and Testing. (
. 1. .)
EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2 ( .
1-2): General requirements for basic safety and essential performance – Collateral standard: electromagnetic
compatibility – Requirements and tests. (
— : —
.)
EN 980: 2008 Symbols for use in labeling of medical devices. (
.)
EN 1041: 2008 Information supplied by the manufacturer of medical devices. ( ,
.)
EN 60601-1-11: 2010 Medical electrical equipment – Part 1-11 ( .
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. ( ,
.)
93/42/EEC.
.
(.
).
.
,
.
,
.
1
Herzog L, Phillips SG. Addressing concerns about fever. Clin Pediatr (Phila) 2011 May;50(5):383-90.
2
Sund-Levander M, Forsberg C, Wahren LK. Normal oral, rectal, tympanic and axillary body
temperature in adult men and women: a systematic literature review. Scand J Caring Sci 2002
June;16(2):122-8.