B.Well WF-4000 Nstructions For Use

WF-4000
Medical digital infrared thermometer
EN Instructions for Use
1. INTRODUCTION
Thank you for choosing the contact-free infrared thermometer WF-4000. The medical digital infrared
thermometer WF-4000 is intended for contact-free measurements of the temperature of body, air and objects.
Scope of use: infrared thermometers are intended for personal use. In addition, the said thermometers can be
used in healthcare institutions and services of healthcare delivery at home.
The operating principle of the thermometer is based on the measurement of infrared radiation, which is emitted by
the surface of a human body or object, by converting it to a value of temperature.
Measurement without touching – unique property of a contact-free thermometer!
The thermometer is characterized by the following advantages:
1. 3-in-1 thermometer – measurement of the temperature of a human body, ambient air and of the surface
temperature of objects.
2. Instant measuring
Thanks to infrared technology users are able to determine the precise temperature of a body instantly and
accurately.
3. Memory recall of 32 saved readings.
The function of memory recall of 32 previously recorded measurement results.
4. Sound signals can be turned off.
5. Elevated temperature warning in the mode of measuring the temperature of a human body.
6. Switch function ° /°F (Celsius/Fahrenheit scale)
7. Automatic shut-off
For saving battery power, the device is automatically switched off if not used for more than 10 seconds.
8. Large LCD display
The device is equipped with a large LCD display, so the results are easy to read.
9. Compliance with hygiene standards.
The contact-free medical thermometer provides for determining temperature based on the requirements
of following the sanitary standards. Just bring the thermometer to the person's forehead at a distance and
measure temperature.
10. Comfortable and easy to use.
The ergonomic design ensures simple and easy use of the thermometer.
2. HIGH TEMPERATURE
High temperature is a symptom, not a disease. As a rule, this means that your organism is fighting an infection. In
fact, this is a defense reaction of our body, which is characterized by an increase in body temperature above 37°C,
heart rate and breathing.
The normal temperature of our body is about 37.5°C, when measured intrarectally, temperature in the mouth is
lower by about 0.5°C (37°C), and temperature in the axillary region is lower by about 1°C (36.5°C).
Therefore, it is very important to measure temperature correctly in the most effective way, and it is advisable not
to do it when the body temperature can be higher (when walking, after eating).
The temperature of a healthy person is influenced by the following factors:
Metabolic individual characteristics
Age (body temperature is higher in infants and young children, and it decreases with age; more significant
temperature fluctuations occur faster and more often in children)
Clothes
Ambient temperature
The time of day (in the morning body temperature is lower, and by the end of the day it becomes higher)
Prior physical activity
Method of measurement
Phase of the menstrual cycle
Skin secretions or sweat on the forehead (when temperature measuring on the forehead)
Remember that the thermometer shall be kept in the room where temperature will be measured for at least half
an hour, otherwise a measurement result may be inaccurate.
METHOD OF MEASUREMENT
Axillary
Orally
Intrarectally
All temperature values displayed in the mode of forehead temperature measurement with an infrared
thermometer are approximately the same as when measured orally with an electronic thermometer.
3. PRECAUTIONS
When using this device, please follow all the specified instructions. If you do not follow the rules below, you can
harm your health or affect the accuracy of measurement.
1. Before measurement, patients and the thermometer should be in the environment with a constant room
temperature for at least 30 minutes.
2. Take a measurement no earlier than 30 minutes after exercising, bathing or being outdoors.
3. Make sure that the forehead is clean and there are no traces of sweat, cosmetics, cream, etc. If necessary, clean
the forehead and wait a few minutes before measuring.
4. When measure somebody continuously, the temperature should be measured every minute, if you need to
measure yourself continuously for a short time, It is a normal phenomenon that there are some slight errors
when you read the temperature. We recommend that you measure yourself continuously maximum of three in a
unit of time then figure out the average and choose it because the temperature of the human will conduct to the
thermometer, it may affect the accuracy of measurement.
5. Please collect the record of Individual temperature under the good condition of body in usual days as a reference
for checking fever or not.
6. Avoid direct contact of fingers with the measuring sensor.
7. The temperature of a human body is constantly changing and depends on various factors.
8. Use the thermometer only for its intended purpose.
9. Using this thermometer is not intended as a substitute for consultation with your physician. It is dangerous for
users to perform a self-evaluation and self-treatment based on the measuring result. please follow doctors
instruction.
10. To protect the environment, dispose the used batteries in accordance with national or local regulations.
CONTRAINDICATIONS: none found
PRECAUTIONS:
1. Keep the thermometer out of reach of children, please consult the doctor at once if the children accidental
swallow of battery or other component.
2. The thermometer shall only be used under the supervision of adults.
3. Do not repair or modify the device.
4. Do not disassemble the device, except for the case of battery replacement.
5. Any modification of the thermometer is not allowed.
6. Do not use the thermometer in a high humidity environment (above 85%) or in direct sunlight, and to measure
very high temperature (above 42°C in the Forehead Temperature Measurement Mode, above 110°C in the Object
Temperature Measurement Mode).
7. Avoid storing the device in damp places, at elevated temperatures, and in direct sunlight.
8. Avoid strong shaking or dropping of the device.
9. Don't throw the battery into fire.
10. Use the thermometer only for its intended purpose.
11. Do not measure the site of forehead temperature if patient has trauma on forehead.
12. Do not measure if patient is treated with certain drug therapies because body temperature may increase in the
drug within the effort time limit.
13. Do not use a mobile or cordless phone near the thermometer when measuring.
14. Please don't measure body temperature in strong electromagnetic interference environment (such as microwave,
high frequency equipment operation environment) to ensure the accuracy of measurement data.
15. This thermometer only a personal device, please do not share with others. lean the appliance as described in
the user manual before using it by other users.
16. Do not touch the battery output when measuring.
17. Please store the thermometer according to the technical specifications.
18. The materials (ABS) of expect contact with patient has passed the ISO 10993-5 and ISO 10993-10 standard test,
no toxicity, allergy and irritation reaction. They are compliant with the MDD requirements based on the current
science and technology, and other potential allergic reactions are unknown.
19. The patent is an intended operator. The patient can measure, read data and replace battery under normal
circumstances and maintain the device and its accessories according to the user manual.
RECOMMENDATIONS
1) Don't use this thermometer for other purposes.
2) lt is forbidden to leave the product exposed to any chemical solvent, direct sunshine or high temperature in case
of damaging the product or the battery
3) Do not measure while talking on the phone.
4) Please report to MANUFACTURER if any unexpected operation or events occurs.
4. CONTROLS AND INDICATORS OF THE THERMOMETER
Control panel
Measurement
LCD sensor
display
Power/
Measurement
button
Battery
cover
Fig. 1.1
Buttons Description
Mode switch Switch measurement mode between a human body and an object
Menu Holding the button down activates the menu and saves settings
Menu/
Memory button
Memory Viewing the memory for up to 32 previously recorded measurements
When viewing the memory: values are scrolled forward
Forward button
When setting: parameters are switched or values are increased
When viewing the memory: values are scrolled back
Backward button
When setting: parameters are switched or values are decreased
5. DESCRIPTION OF THE DISPLAY
Object Temperature
Mode
Body
Temperature Mode
Temperature
value
Sound On
6. INSTALLATION AND REPLACEMENT OF BATTERIES
Low battery warning:
When the battery symbol appears on the screen
When the battery symbol flashes on the display
measurement.
Battery replacement:
1. Slide the battery cover carefully (Fig. 3).
2. Carefully remove old batteries and dispose them properly.
3. Insert new batteries (two 1.5 V AA batteries) observing polarity.
4. Slide the battery cover back.
NOTE:
Keep batteries out of reach of children and away from heat sources.
It is recommended to remove batteries if the device will not be used for a long time.
7. TEMPERATURE MEASUREMENT
7.1 Body temperature measurement:
1. Press the Power/Measurement button to switch on the thermometer.
2. After switching on, the device immediately starts automatic testing with all screen elements displayed, and then
operational readiness is displayed (Fig. 4.1).
3. Make sure the device is in the Body Temperature Mode (Body temp) as shown in the figure. If necessary, switch
the mode.
4. Point the front end of the thermometer at the forehead. Keep the thermometer about 5-8 cm away from the
forehead (Fig. 4.4).Press and release the Power/Measurement button. You will hear a short sound signal indicating
that a measurement has been taken. The recorded temperature will be displayed on the screen (Fig. 4.2).
If temperature exceeds 37.5°C, three sound signals will be heard indicating that your temperature is elevated.
5. After measurement, if the thermometer is not used for 10 seconds, OFF (i. e. switched off) will be displayed
(Fig. 4.3), a sound signal will be given, and the thermometer will switch off automatically.
Fig. 4.1 Fig. 4.2
REFERENCE TEMPERATURE VALUES
35,2 - 36,7°
35,7 - 37,3°
36,2 - 37,7°
Object Temperature Mode
Mode (Object temp) switch
Menu/ Forward
Memory button button
Fig. 1.2
Celsius scale
Fahrenheit scale
Memory symbol
Low battery warning
Fig. 2
, batteries will soon require replacement.
, batteries need to be replaced before the next
5-8 m
Fig. 4.3
7.2 Measuring the temperature of water, air and surface of objects:
1. Press the Power/Measurement button to switch on the thermometer.
2. After switching on, the device immediately starts automatic testing with all screen elements displayed, and then
operational readiness is displayed (Fig. 5.1).
3. Make sure the device is in the Object Temperature Mode (Object temp) as shown in the figure. If necessary,
switch the mode.
4. Point the front end of the thermometer at a point in space, surface of water or at an object. Bring the
thermometer to an object at a distance about 5 to 8 cm (Fig. 5.4). Press and release the Power/Measurement
button. You will hear a short sound signal indicating that a measurement has been taken. The measured
temperature will be displayed on the screen (Fig. 5.2).
5. After measurement, if the thermometer is not used for 10 seconds, OFF (i. e. switched off) will be displayed
(Fig. 5.3), a sound signal will be given, and the thermometer will switch off automatically.
Fig. 5.1
8. USE OF SETUP FUNCTIONS:
By activating the settings menu, users can select certain functions (F1/F2/F3/F4) and configure them as required.
8.1 Switching between Body and Object Temperature Measurement Modes:
1. Press the Power/Measurement button to switch on the thermometer.
2. After switching on, the device immediately starts automatic testing
with all screen elements displayed, and then operational readiness
is displayed (Fig. 6.1).
3. When the thermometer is switched on, the current measurement mode
is displayed. If you need to change a measurement mode, use the Mode
Switch button to switch to the Body Temperature Mode (Body temp)
or the Object Temperature Mode (Object temp) (Fig. 6.2).
8.2 Switching between Celsius and Fahrenheit scales: F-1
1. To activate the settings menu, press and hold the Menu/Memory button.
2. F-1 setting will be displayed on the screen.
3. Press "+" to select the Fahrenheit scale (˚F symbol will flash on the
screen), or press "-" to select the Celsius scale (˚ symbol will flash on
the screen) (Fig. 7).
8.3 Sound settings: F-2
1. Press the Menu/Memory button again after F1 setting
to display F-2 setting. The sound signal is set to OPEN
(i. e. enabled) by default.
2. Press "+" to switch on a sound signal, and OPEN
will be displayed (i. e. enabled). Press "-" to switch
off a sound signal, and CLOS will be displayed
(i. e. disabled) (Fig. 8).
8.4 Setting a signal indicating elevated
temperature: F-3
If ≥37.5°C is measured, the thermometer will sound 3 beeps. The default
temperature is set to 37.5°C. You can change this temperature value
using the setting:
1. Press the Menu/Memory button again after F-2 setting to display
F-3 setting. By default, the temperature will be displayed at 37.5°C.
(Fig. 9)
2. Press "+" or "-" to increase or decrease the value of elevated
temperature. The value will increase or decrease in increments of 0.1°C.
8.5 Setting of a deviation value: F-4
Some people have individual characteristics when measuring body
temperature. For example, if the forehead temperature measurement
is significantly different from the oral temperature measurement,
a deviation setting can be used.
1. Press the Menu/Memory button again after F-3 setting to display
F-4 setting. The default deviation is 0.8°C (Fig. 10).
2. Press "+" or "-" to increase or decrease the deviation value. The value will
increase or decrease in increments of 0.1°C.
8.6 Save values and exit (automatic shut-off):
1. Press the Menu/Memory button again after F-4 setting to save settings,
SAVE will be displayed (i. e. to save).
2. All settings will be saved, and the thermometer will switched off
automatically (Fig. 11).
NOTE: New settings will not be saved if the thermometer is switched off
during the setup procedure.
After the settings menu activation, the thermometer cannot measure temperature. When the Power/
Measurement button is pressed, the thermometer will not switch to measurement mode.
9. MEMORY FEATURE
Recall memory:
You can recall 32 previously recorded measurements to show them to your doctor or a qualified health care
professional.
1. When the device is on, press the Menu/Memory button. The Memory button will display the previously recorded
measurement, which will be accompanied by displaying the "M" symbol.
2. Press "+" or "-" to scroll 32 previously recorded measurement results.
3. Press the Power/Measurement button to exit the Memory Function and change to the Temperature
Measurement Mode.
10. TROUBLESHOOTING
11. CARE AND MAINTENANCE
Measurement sensor
Carefully clean with an alcohol-soaked swab. Do not use water for
cleaning the lens.
Thermometer housing
Clean with a soft dry cloth. Do not use water for cleaning the device.
12. SPECIFICATIONS AND PACKAGE CONTENTS
Dimensions
Weight
Temperature range
Body temperature
Object temperature
Measurement accuracy
Body temperature
Object temperature
Resolution
Operation conditions
Storage temperature
Memory capacity
Battery
Body Temperature
PACKAGE CONTENTS
Mode (Body temp)
Medical digital infrared thermometer;
Batteries: 1.5 V AA batteries (2 pcs.);
Case bag;
Instructions for Use.
13. STANDARD COMPLIANCE
ISO 15223-1: Symbols for use in the labeling of medical devices.
EN 1041: Information supplied by the manufacturer with medical devices.
EN 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
Backward EN 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential
button performance – Collateral standard: Electromagnetic compatibility-Requirements and tests.
EN 60601-1-6: Medical electrical equipment – Part1-6: General requirements for basic safety and essential
performance – Collateral standard: Usability.
EN 60601-1-11: 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 home healthcare environment.
EN 12470-5: Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with maximum device).
ISO 80601-2-56: Medical electrical equipment part 2-56: particular requirements for basic safety and essential
performance of clinical thermometers for body temperature measurement.
EN 62304: Medical device software – Software life-cycle processes.
EN 62366: Medical devices – Application of usability engineering to medical devices.
EN ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process.
14. STORAGE
Storage temperature: –25°C to 55°C (–13°F to 131°F).
Relative humidity should not exceed 85%.
Protect the thermometer against falls and bumps.
Protect the thermometer against direct sunlight.
15. DISPOSAL
The device shall be disposed in accordance with the accepted regulations and shall not be disposed with household
wastes.
16. DESIGNATION OF SYMBOLS
Refer to the Instructions
for Use
BF type device
Do not dispose with
household wastes
MANUFACTURER
SERIAL NUMBER
17. 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.
The manufacturer may change units partially or completely if necessary, without prior notice.
The date of manufacture of the device is specified in the serial number indicated on the device. The first two digits
indicate the year, and the following two digits indicate the month of production.
Fig. 3
18. EMC DECLATION
1. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
2. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
the Infrared Thermometer could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation
3. Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the Infrared Thermometer, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Last revision 2020-W50
B.Well Swiss AG
Bahnhofstrasse 24, 9443 Widnau, Switzerland
Fig.4.4
www.bwell-swiss.ch
Fig. 5.2 Fig. 5.3
Cause
The measured temperature is lower than the following
values:
1. 32.0°C (89.6°F) if the thermometer is in the Body
Temperature Measurement Mode.
2. 0°C (32.0°F) if the thermometer is in the Object
Temperature Measurement Mode.
The measured temperature is higher than the following
values:
1. 42°C (107.6°F) if the thermometer is in the Body
Temperature Measurement Mode.
2. 110°C (230.0°F) if the thermometer is in the Object
Temperature Measurement Mode.
The ambient temperature is outside the range of
16°C ~ 40°C (60.8°F to 104°F).
93 41 153 mm
95 g (without batteries)
32°C~42°C (89,6°F - 107.6°F)
0°C~110°C (42°F - 230°F)
32°C~42°C : ± 0,2°C (89,6°F~107,6°F : ± 6,76 °F)
0°C~110°C : ± 1°C (32°F ~ 230°F: ±8 °F)
0,1°C
16°C to 40°C (60.8°F to 104°F) (at a relative humidity of not more than 85%)
–25°C to 55°C (–13°F to 131°F) (at a relative humidity of not more than 85%)
32 measurements
1.5 V AA batteries (2 pcs.)
MODEL
CE certification
0044
Housing Ingress Protection rate: IP22
(Protected from the penetration of solid bodies
with dimension greater than 12.5 mm. Protected
from the penetration of vertically falling
water drops)
40
16
Operating temperature limit
55
Storage temperature limit
-25
5-8 m
Fig. 5.4
Fig. 6.1 Fig. 6.2
Fig. 7
Fig. 8
Fig. 9
Fig. 10
Fig. 11
Solution to the problem
Use the thermometer
only within the specified
temperature ranges.
If necessary, clean the
sensor tip.
If you receive a repeated
error message, contact
your service center.
Use the thermometer
only in rooms with an air
temperature of 16°C to
40°C (60.8°F to 104°F).