B.Well MED-3000, User Manual

Page: 6 / 8

Memory Deletion
1. Remove one of the batteries, long press the ON Button.
2. Reload the battery until “
” on the LCD screen.
Automatically on the 26th measurement: when the 25 memories have
been used up, any new measurement will be recorded and the oldest
memory deleted without you having to do anything.
NOTE:
All the readings will be cleared no matter record in Body Mode or
Object Mode.
15. CLEANING INSTRUCTIONS
For the device disinfection, 75% alcohol (available in the pharmacy)
can be used.
Measurement Sensor:
Please wipe with a clean and dry cotton swab to clean the Sensor on
the inside. Do not use water, the Sensor is not waterproof.
Thermometer:
Use a soft and dry cloth to clean the thermometer body. Do not use
abrasive cleaners. The body of the thermometer is not water-resistant.
Never put the thermometer under a running tap or submerge it into
water.
Store the thermometer in a cool and dry location. Free from dust and
away from direct sunlight. Do not expose the thermometer to extreme
temperatures, humidity, or shock.
16. TROUBLESHOOTING
FAULT OR
FAULT SYMBOL
FAULT DESCRIPTION
CORRECTIIVE
MEASURE
No display On
the LCD pane.
The battery has run
out. Incorrect battery
polarity.
Replace the
battery.
Please note:
The (+) side of
the battery must
face Positive (+)
indication on the
device.
Measurement
not possible (or
an abnormal
value is
displayed).
The thermometer is not
ready.
Wait until
the °C symbol is
displayed.
An abnormal
temperature
value is
displayed.
The Sensor is dirty or
damaged.
Clean the Sensor
or get it repaired.
The thermometer was
removed too early
(before the beep sound).
Wait until you
hear the beep
before removing
the thermometer
from the forehead.
or
symbol is
displayed.
The temperature
measured is outside the
measuring range.
Body Mode:
LO – temperature
<32°C (89.6°F).
HI – temperature
≥42,9°C (109.3°F)
Object Mode:
LO – temperature
<0°C (32°F).
HI – temperature
≥100°C (212°F).
Check that the
probe tip is clean
and that the
thermometer is
properly placed
on the forehead.
Symbol is
displayed.
The battery has run out.
Replace the
battery.
Err
Symbol is
displayed.
The ambient
temperature is
outside the operating
temperature range or is
changing too fast.
To ensure accurate
measurement, let
the thermometer
rest at operating
temperature for
30 minutes prior
to use.
22. SYMBOL INFORMATION
IP20
FOLLOW INSTRUCTIONS BEFORE USE
MANUFACTURER’S NAME
ARTICLE NUMBER
SERIAL NUMBER
TYPE BF EQUIPMENT
DISPOSAL FOR SEPARATE COLLECTION
CE MARK (0044)
OPERATING CONDITION,
TEMPERATURE 5˚C ~ 40˚C
STORAGE CONDITION,
TEPERATURE -25˚C ~ 70˚C
KEEP DRY
HOUSING INGRESS PROTECTION RATE: IP20
0044
40
5
-25
70
17. APPLIED STANDARDS
Device Standards:
Device Corresponds to the requirements of the standard for infrared
thermometers
IEC 60601-1:2012
IEC 60601-1-2:2014
ISO 80601-2-56:2009
Classifi cation:
Anti-electric Shock Type: Internally powered equipment
Applied part: Type BF
Mode of operation: Continuous Operation
EMC: type B class I
Electromagnetic Compatibility:
Device fulfi lls the stipulations of the standard IEC 60601-1-2
The stipulations of EU-Directive 93/42/EEC for Medical Devices
Class Ila have been fulfi lled.
18. PRODUCT SPECIFICATIONS
Measurement range:
Human Body:
Object:
32,0 ~ 42,9°C (89,6°F ~ 109,3°F)
0,0°C ~ 100°C (32,0°F ~ 211,8°F)
Accuracy:
For Body mode:
For Object mode:
±0,2°C (±0,4°F):
36,0°C ~ 39,0°C (96,8°F ~ 102,2°F)
±0,3°C (±0,5°F): out of the range
±1°C (±2°F):
0°C ~ 60,0°C (32,0°F ~ 140,0°F)
±4°C (±7,2°F): out of the range
Display resolution: 0,1°C or 0,1°F
Temperature unit: Default °C or Default °F
Operation Distance: 3 cm
Traffi c lights backlight
(Body mode), Indicator
light range:
Green: <37,5°C (<99,5°F);
Yellow: ≥37,5°C - ≤37,9°C (≥99,5°F -
≤100,2°F);
Red: > 37,9°C ( > 100,2°F)
Beeps defi nition: Power on and ready for working: a
short beep
Measurement fi nished:
1 long beep ≤37,9°C (100,2°F)
6 short beeps >37,9°C (100,2°F)
Memory: 25 mesurements
Auto shut-off: about 10 seconds after no using
Batteries: 2 x 1.5V AAA size alkaline batteries
Dimensions (L×W×H): 142,5 mm × 38 mm × 40 mm
Weight: 76g (Net: 54g)
Operating environment: Temperature:
+5°C ~ +40°C (41°F ~ 104°F);
Humidity:
15% ~ 93 % RH (non-condensing);
70Kpa-106Kpa.
Transport and Storage
environment:
Temperature:
-25°C ~ +70°C (-13°F ~ 158°F);
Humidity:
15% ~ 93% RH (non-condensing).
19. THERMOMETER SET
Thermometer set:
1. Thermometer
2. Battery 2 x 1.5V AAA size alkaline batteries
3. Soft bag
4. Instructions for use
20. UTILIZATION
The unit must be utilized in accordance with current standards
separately from domestic wastes. For utilizing it is necessary to
contact special organizations licensed to make utilization.
21. WARRANTY
Warranty period is 2 years from the date of purchase.
This warranty doesn’t cover any damages caused by improper
using, and also battery, protective cover and packaging. When a
manufacturing defect is revealed during the warranty period a faulty
unit would be repaired or, if repairing is impossible, replaced with
another one.
Manufacturing date is on the unit in a serial number: last 2 fi gures of
the year, then month number.
The manufacturer may change units partially or completely if
necessary, without prior notice.
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Manufacturer’s Declaration of the Electromagnetic
Compatibility
Table 1
Guidance and manufacturer’s declaration –
еlectromagnetic emissions
Emissions test Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not application
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not application
Table 2
Guidance and manufacturer’s declaration –
еlectromagnetic immunity
Immunity test
IEC 60601-1-2
Test level
Compliance level
Electrostatic discharge
(ESD)
IEC 61000-4-2 ±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air ±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Electrical fast transient/
burst
IEC 61000-4-4
Power supply lines: ±2 kV
input/output lines: ±1 kV
Not application
Surge
IEC 61000-4-5
line(s) to line(s): ±1 kV.
line(s) to earth: ±2 kV.
100 kHz repetition
frequency
Not application
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
0% 0.5 cycle
At 0°, 45 °, 90 °,
135 °, 180 °, 225 °, 270 °
and 315 °
0% 1 cycle
And
70% 25/30 cycles
Single phase: at 0
0% 300 cycle
Not application
Power frequency
magnetic fi eld
IEC 61000-4-8
30 A/m
50Hz/60Hz 30 A/m
50Hz/60Hz
Conduced RF
IEC 61000-4-6
150KHz to 80MHz:
3Vrms
6Vrms (in ISM and
amateur radio bands)
80% Am at 1kHz
Not application
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz 10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
NOTE U
T
is the a.c. mians voltage prior to application of the test level.
Remark In the presence of strong electromagnetic fi eld (Horizontal/Vertical,
80MHz~180MHz and 1.4GHz~2GHz, 10V/m applied on the product), it will have
a change from 0.1°C to 0.3°C of the measured value. In case of malfunction due
to these strong electromagnetic fi elds, user need to wait till resume normal
operation without intervene.
IM_MED-
3000_EN_5
120
B.Well Swiss AG
Bahnhofstr. 24, 9443 Widnau, Switzerland
www.bwell-swiss.ch
Table 3
Guidance and manufacturer’s declaration –
electromagnetic Immunity
Radiated RF
IEC61000-4-3
(Test
specifi cations
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Test
Frequency
(MHz)
Band
(MHz)
Service
M
odulation
M
odulation
(W)
Distanc
e
(m)
IMMUNITY
TEST
LEVEL
(V/m)
385
380 –
390
TETRA 400
Pulse
modulation
18 Hz
1,8 0.3 27
450
380 –
390
GMRS 460,
FRS 460
FM
± 5 kHz
deviation
1 kHz sine
2 0.3 28
710
704 –
787
LTE Band
13, 17
Pulse
modulation
217 Hz
0,2 0.3 9 745
780
810
800 –
960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
18 Hz
2 0.3 28
870
930
1720
1 700 –
1 990
GSM 1800;
CDMA
1900;
GSM 1900;
DECT;
LTE Band 1,
3, 4, 25;
UMTS
Pulse
modulation
217 Hz
2 0.3 28
1845
1970
Last revision 2020-W51