Product specifications
Displayed temperature range:
93.2 – 108 °F
(34 – 42.2 °C)
Operating ambient temperature range:
50 – 104 °F
(
10 – 40 °C)
Display resolution:
0.1 °F or °C
Accuracy for displayed temperature range
Maximum Laboratory Error
95 °F – 107.6 °F (35 °C – 42 °C):
± 0.4 °F
± 0.2 °C
outside this range:
± 0.5 °F
± 0.3 °C
clinical repeatability:
± 0.26 °F
± 0.14 °C
Long term storage ranges
Storage/transport temperature:
-13 °F to 131 °F
(-25 °C to 55 °C)
Humidity:
15-95% non condensing
Battery life:
2 years / 600 measurements
Service life:
5 years
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).
See instruction for use
Equipment with type
BF applied parts
50 °F
(10 °C)
104 °F
(40 °C)
Operating temperature
Keep it dry
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 Customer Service.
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.
Attention, consult
ACCOMPANYING
DOCUMENTS
Guidance and manufacturer’s declaration – electromagnetic emissions
The ME equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME equipment should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment – guidance
RF Emissions
CISPR 11
Group 1
The ME equipment uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B
Complies
Harmonic emissions IEC
61000-3-2
Not Applicable
The ME equipment is
solely battery powered.
Voltage fluctuations /
flicker emissions
Not Applicable
Non-Life Support Equipment Separation Distance Calculation (3Vrms / 3V/m compliance)
Rated maximum output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz in ISM bands
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
Guidance and manufacturer’s declaration – electromagnetic immunity
The ME equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME equipment should ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6kV Contact
±8kV Air
Complies
Floors should be wood, concrete, or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30%.
Radiated RF
IEC 61000-4-3
3 V/m 80MHz to 2.5GHz
Complies
Field strengths outside the shielded location from
fixed RF transmitters, as determined by an
electromagnetic site survey, should be less than 3
V/m.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Separation distance calculation provided above. If a
known transmitter is present the specific distance
can be calculated using the equations.
Conducted RF
IEC 61000-4-6
3Vrms 150kHz to 80MHz
Not Applicable
(no electrical cabling)
Electrical fast transient
IEC 61000-4-4
±2kV power line
±1kV I/O lines
Not Applicable
The ME equipment
is solely battery powered.
Surge
IEC 61000-4-5
±1kV differential
±2kV common
Not Applicable
Power frequency magnetic field
IEC 61000-4-8
3 A/m
Complies
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
>95% dip 0.5 cycle
60% dip 5 cycles
70% dip 25 cycles
95% dip 5 sec.
Not Applicable
The ME equipment
is solely battery
powered.
d
= [
3,5
V
]
P
1
d
= [
3,5
E
]
P
1
d
= [
7
E
]
P
1
