Braun ThermoScan 5 Mode D'emploi page 12

Product specifications
Displayed temperature range:
Operating ambient temperature range:
Display resolution:
Accuracy for displayed temperature range
95 °F – 107.6 °F (35 °C – 42 °C):
outside this range:
clinical repeatability:
Long term storage ranges
Storage/transport temperature:
Humidity:
Battery life:
Service life:
This thermometer is specified to operate at 1 atmospheric pressure (700-1060hPA) or at altitudes with an
atmospheric pressure up to 1 atmospheric pressure (700-1060hPA).
Equipment with type See instruction for use
BF applied parts
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 requirementsin the display range of 98 to 102 °F (37 to 39 °C) for IR
thermometers is +0.4 °F (+0.2 °C), whereas for mercury in- glass and electronic thermometers, the
requirement per ASTM Standards E 667-86 and E 1112-86 is +0.2 °F (+0.1°C).
Standard Reference Edition Title:
EN 12470-5: 2003 Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum
device).
IEC 60601-1: 2006, ANSI/AAMI ES 60601-1:2006 Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance.
ISO 14971: 2012 Medical devices – Application of risk management to medical devices.
ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Evaluation and Testing within a risk
management process.
IEC 60601-1-2: 2007 Medical electrical equipment – part 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.
IEC 60601-1-11: 2010 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.
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed description of
EMC requirements please contact Customer Service.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.
10
93.2 – 108 °F
50 – 104 °F
0.1 °F or °C
Maximum Laboratory Error
± 0.4 °F
± 0.5 °F
± 0.26 °F
-13 °F to 131 °F
15-95% non condensing
2 years / 350 measurements
5 years
104 °F
50 °F
(40 °C)
(10 °C)
Operating temperature
Keep it dry
(34 – 42.2 °C)
(10 – 40 °C)
± 0.2 °C
± 0.3 °C
± 0.14 °C
(-25 °C to 55 °C)
Attention, consult
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