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Product specifications
Displayed temperature range:
Operating ambient temperature range:
Storage temperature range:
Operating and storage relative humidity:
Display resolution:
Accuracy for displayed temperature range
35 – 42 °C (95 – 107.6 °F):
Outside this range:
Clinical repeatability:
Battery life:
Service life:
This thermometer is specified to operate at 1 atmospheric pressure or at altitudes with an atmospheric
pressure up to 1 atmospheric pressure (700 - 1060 hPa).
40 °C
10 °C
Equipment with
See Instruction for use
Operating temperature
type BF applied parts
Subject to change without notice.
This appliance conforms to the following standards:
Standard Reference Edition Title:
EN 12470-5: 2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with
maximum device).
EN 60601-1: 2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
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 within a risk
management process.
EN 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.
EN 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 your authorized local Service Centre (See guarantee card).
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.
Please do not dispose of the product in the household waste at the end of it useful life.
To protect the environment, dispose of empty batteries at appropriate collection sites according to
national or local regulations.
10
All manuals and user guides at all-guides.com
34 – 42.2 °C
(93.2 – 108 °F)
10 – 40 °C
(50 – 104 °F)
-25 – 55 °C
(-13 – 131 °F)
10-95% RH (non condensing)
0.1 °C or °F
Maximum Laboratory Error
±0.2 °C
(±0.4 °F)
±0.3 °C
(±0.5 °F)
±0.14 °C
(±0.26 °F)
2 years / 350 measurements
5 years
Storage temperature
Keep it dry
Guidance and manufacturer's declaration – electromagnetic emissions
The IRT6520LA equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the IRT6520LA should ensure that it is used in such an environment.
Emissions Test
Compliance
The ME equipment uses RF energy only for its internal
RF Emissions
function. Therefore, its RF emissions are very low and are not
Group 1
CISPR 11
likely to cause any interference in nearby electronic
RF Emissions
Class B
CISPR 11
Harmonic emissions
Not
IEC 61000-3-2
Applicable
Voltage fluctuations /
Not
flicker emissions
Applicable
Non-Life Support Equipment Separation Distance Calculation
(3Vrms / 3V/m compliance)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
Rated maximum output
in ISM bands
power of transmitter (W)
3,5
d = [
] P
V
1
0.01
0.12
0.1
0.37
1
1.17
10
3.69
100
11.67
Electromagnetic environment – guidance
equipment.
Complies
The ME equipment is
solely battery powered.
80 MHz to
800 MHz to 2.5 GHz
800 MHz
3,5
7
d = [
] P
d = [
] P
E
E
1
1
0.12
0.23
0.37
0.74
1.17
2.33
3.69
7.38
11.67
23.33
11
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