Romed-Holland THERM-DIG Manual

Romed Digital Thermometers
(Not waterproof)
Model: THERM-DIG
ON/OFF Battery
Thermometric
compartment
sensor LCD Button
Thermometric tip
Congratulations on your purchase of this product. Please
read the instructions carefully before using the
thermometer for the first time, and keep these in a safe
place. This product is intended for the measurement of
human body temperature in people of all ages. This
product is for home and hospital use, operator shall be at
least 11 years old and patient can be operator.
Operating Instructions
Before using, please disinfect the probe at first. To switch
on, press the ON/OFF button next to the display; a short
beep will sound, indicating that the thermometer is opera-
tional. At the same time the thermometer runs a self-check
test, during which all the digital segments appear on the
LCD. When the letters "Lo" and a flashing " C" display,
o
the thermometer is now ready for use. If the ambient
tempera-ture is below 32 o C, then "Lo o C" will appear on
the LCD and if it is more than 42.9 C, then "Hi
o
appear on the LCD. During the reading, the current
temperature is displayed continuously and the "
flashes. The measurement is completed when a constant
temperature value has been reached. The temperature
value is considered constant when the temperature rises
less than 0.1 C within 16 seconds. As soon as the
o
constant temperature value is reached, a beep will sound
ten times, and the " o C" symbol will stop flashing. The
highest temperature measured appears on the LCD.
However, please note that this thermometer is a maximum
thermometer, i.e. the displayed temperature can increase
slightly if measurement continues after the beep. This is
particularly the case with axillary measurements, should a
temperature value be recorded which approximates the
core body temperature. In this instance please note the
description under "Methods of measuring temperature".
When the measurement is completed, please switch the
thermometer off by pressing the ON/OFF button. After the
temperature has been displayed, the thermometer will shut
off automatically in 10 minutes.
Memory function
Switch the thermometer on, a short beep will sound. At the
same time the thermometer runs a self-check test,
duringwhich all the digital segments appear on the LCD.
After that the last reading value with " o C" automatically on
the LCD for about 2 seconds. The reading is only over-
written when a new temperature value is recorded.
Methods of measuring temperature
It is important to remember that the body temperature
reading depends on the site where it is measured. For this
reason, the measurement site must always be specified in
0044
order to ensure that a correct temperature reading is
recorded.
In the rectum (rectal)
This is the most accurate method from a medical point of
view, because it comes closest to the core body tempera-
ture. The thermometer tip is inserted carefully into the
rectum for a maximum of 2 cm. The usual measuring time
is approximately 40 to 60 seconds.
Under the arm (axillary)
Placing the thermometer in the armpit provides a
measurement of surface temperature that can fluctuate by
around 0.5 o C to 1.5 o C from rectal temperature readings
in adults. The usual measuring time for this method is
approximately 80 to 120 seconds. It should be noted,
however, that an exact reading cannot be obtained if, for
example, the armpits have been allowed to cool. If this is
the case, we recommend extending the measuring time
by around 5 minutes in order to obtain the most precise
possible reading that corresponds as closely as possible
to the core body temperature.
In the mouth (oral)
There are different heat zones in the mouth. As a general
rule, the oral temperature is 0.3
rectal temperature. To ensure that reading is as accurate
as possible, place the thermometer tip to the left or right of
the root of the tongue. The thermometer tip must have
constant contact with the tissue during the reading and be
C" will
o
placed under the tongue in one of the two heat pockets at
the back, keep the mouth closed during the reading and
C" symbol
o
breathe evenly through the nose. Do not eat or drink
anything before the measurement. The usual measuring
time is approximately 50 to 70 seconds.
Note: We strongly recommend the rectal method as the
most accurate method for identifying the basal tempera-
ture, and advise you to extend the measuring time by 3
minutes after the beep.
Cleaning and disinfection
The best way to clean the thermometer tip is by applying a
disinfectant (e.g. 70% ethyl alcohol) with a damp cloth. It
shall be disinfected before each use. The not waterproof
thermometers can't be immersed in liquid or lukewarm
water for through cleaning and disinfection.
Summary of use specification
The usability engineering process assesses and mitigates
risks caused by usability problems associated with correct
use and use errors. The usability study shows that the
acceptance criteria documented in the usability validation
plan have been met, and the residual risks associated with
the usability of a medical device as defined in ISO 14971,
are acceptable.
Safety precautions
Do not allow the device to come into contact
with hot water.
Do not expose to high temperatures or direct sunlight.
Do not drop the thermometer. It is neither shock-proof
nor impact-resistant.
Do not modify this device without authorization of
manufacturer
Do not clean with thinners, petrol or benzenel. Only
clean with water or disinfectant.
Do not immerse the non waterproof thermometers
under water.
The thermometer contains small parts (battery, battery
compartment) which can be swallowed by children. For
this reason, do not leave the thermometer unattended in
the hands of children.
If the ambient temperature is over 40
thermometer tip which comes in contact with the patient
(with stainless steel cover) in cold water for approx. 5 to
10 seconds prior to measuring the temperature.
Persistent fever, in particular in children, has to be
treated by a doctor- please get in touch with your doctor!
Do not use near strong electromagnetic fields, i.e. keep
it away from any radio systems and mobile phones.
Battery replacement
The battery is empty and needs replacing when the "
or " " battery symbol appears on the right of the LCD.
Remove the battery cover and remove the battery by
C to 0.8 C lower than the
o o toothpick, replace it with a battery(preferably non-mercury)
of the same type. the "+" sign up and "-" sign down.
We advise you to remove the batteries if the device is not
going to be used for a longer period of time.
Product disposal
Please ensure environmental protection. Batteries do not
belong in the domestic waste. Please hand them in at
collection point or the municipal recycle material centre as
special waste.The lithium battery or fuel cell may lead to
excessive temperatures, fire or explosion.
This symbol on products and/or accompanying documents
means that consumed electronic products
must not be mixed with conventional domestic
waste.
Take these products to the corresponding collection points
for correct treatment and recycling, where they will be
accepted free of charge. For more information on the
closest collection point, Please enquire with your local
authorities.
Technical data
Type: maximum thermometer
Measurement range:(32.0~ 42.9)
Measurement accuracy:
+/- 0.1 C (35.5
o
+/-0.2 C (<35.5
o
Storage/transportation temperature: (-25~55)
Ambient temperature during use: (5~40)
Atmospheric pressure:700~1060hPa
Mode of operation of the clinical thermometer: direct mode
Transient response time: 12s
Min Scale: 0.1
Battery type: Alkaline manganese battery, type LR41,
1.5V, service life minimum 100 hours under continuous
operation.
Weight: approx. 12g
LOT
C, dip the
o
Legal requirements and guidelines
This product complies with the European Directive for
Medical Device 93/42/EEC and carries the CE mark, the
device also complies with the specifications of below
standard for:
ISO 80601-2-56-2017 AMD.1:2018,
"
EN 60601-1, EN 60601-1-11, EN 60601-1-2
The CE Marking confirms that this is a medical device with
a measuring function in the sense of the medical device
act which has undergone a conformity assessment
procedure. A Notified body confirms that this product
fulfills all the appropriate statutory regulations
Calibration check
This thermometer is initially calibrated at the time of
manufacture. If this thermometer is used according to the
operation instruction, periodic re-adjustment is not
required.
The calibration check has to be carried out immediately, if
there are indications that the product does not keep the
defined error limits or the calibration properties could have
been affected by an intervention or by any other means.
Please also observe any national statutory regulations.
The calibration check can be carried out by the competent
authorities or by authorised service providers. A test
instruction for calibration check can be provided to the
relevant authorities and authorised services providers on
request.
Limited warranty
This ROMED thermometer is guaranteed for 90 days from
o C
the date of purchase against manufacture's defect under
normal use. If your unit does not function properly due to
C~42.0 C)
o o
C,>42.0 C) defective parts of assembly, we will repair it free of
o o
charge. All parts are covered by this warranty including
o C, ≤95%RH
the battery. The warranty does not cover damage to your
o C, ≤80%RH
unit due to improperly handling.
C
o
Explanation of symbols
Manufacturer
Unique device identifier
Manufacturing date
Medical device
CE marking
EAN barcode
Lot number Caution
Follow instructions for use
Temperature limit
Humidity limitation
TypeBF equipment
The battery in this product complies with the
requirements stated in European Directives
2006/66/EEC.
or battery check
VAN OOSTVEEN MEDICAL B.V. - ROMED HOLLAND
HERENWEG 269, 3648 CH WILNIS, THE NETHERLANDS
WWW.ROMED.NL
V002,2022-08