Biltema 84-177 Bedienungsanleitung
Biltema
Thermometer
84-177
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© 2024-05-21 Biltema Nordic Services AB
Art. 84-177
DIGITAL FEBERTERMOMETER
DIGITALT FEBERTERMOMETER
DIGITAALINEN KUUMEMITTARI
DIGITALT FEBERTERMOMETER
20 sek/sek.
Biltema, Garnisonsgatan 26, 2nd FL, SE-254 66 Helsingborg. www.biltema.com
JOYTECH HEALTHCARE CO. LTD.
No.365 Wuzhou Road, 311100 Zhejiang Province,
PEOPLE’S REPUBLIC OF CHINA
Shanghai International Trading Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
0197
Tillverkat för Biltema, Garnisonsgatan 26, 2nd FL, 254 66 Helsingborg.
www.biltema.com
Manual version: 1.0

v
2
© 2024-05-21 Biltema Nordic Services AB
Art. 84-177
SE
DIGITAL FEBERTERMOMETER
SYMBOLER PÅ PRODUKTEN
Läs manualen
0197
Produkten överensstäm-
mer med kraven i MDR
(EU) 2017/745, "0197"är det
anmälda organets identika-
tionsnummer.
Tillverkare
Auktoriserad representant i
EU.
Typ BF tillämpad del.
El-avfall
Förbrukade elektriska och
elektroniska produkter, däri-
bland alla typer av batterier,
ska lämnas till avsett insam-
lingsställe för återvinning.
(Enligt direktiv 2012/19/EU och
2006/66/EC).
LOT-numret har fem siffror och
ger tillverkningsinformation.
Första siffran anger årtal (0–9)
och andra siffran anger månad
(1–9, jan – sep, och A – C,
okt – dec). Tredje och fjärde
siffran anger datum (1–31) och
femte siffran anger månadens
batchnummer.
För fler symboler, se sidan 14.
DETALJFÖRKLARING
124mm
380mm
PLEASE READ CAREFULLY BEFORE USING
SPECIFICATIONS
℃/℉
SWITCHABLE
Temperature readings are available in the Celsius or Fahrenheit scale (℃/℉; located in the
upper right corner of LCD.) With the unit off, press and hold the On/Off Button for
approximately 2 seconds to change the current setting.
32.0℃-43.9℃(90.0℉-111.9℉ )( ℃ /℉ chosen by manufacturer)
±0.1℃(±0.2℉) during 35.5℃~42.0℃(95.9℉~107.6℉) at
18℃~28℃ (64.4℉~82.4℉ ) ambient operating range
±0.2℃(±0.4℉) for other meas
uring and ambient operating range
Measure Range:
Ambient operating range:
Storage and transportation
condition:
Liquid crystal display, 3 1/2 digits
For storing the last measured value
One 1.5 V DC. button battery (size LR41or SR41, UCC 392)
Temperature: ( )5℃~40℃ 41℉~104℉
Relative humidity: 15%~95%RH
Atmospheric Pressure : 70kPa ~ 106kPa
Temperature: ( )-20℃~55℃ -4℉~131℉
Relative humidity: 15%~95%RH
Atmospheric Pressure : 70kPa ~ 106kPa
Classification:
Type:
Digital Th
ermometer (Predictive)
Type BF
Ingress Protection Rating:
Accuracy:
Display:
Memory:
Battery:
Battery life:
Dimension:
Weight:
Expected service life: Three years
Operating mode: Adjusted mode: mode
Predictive
Approx. 200hours of continuous operation or 1 year with 3
measurements per day
CONTENTS
1 Thermometer, 1 Owner s Manual, 1 Storage Case
’
PRECAUTION
*The performance of the device may be degraded should one or more of the following occur:
- Operation outside the manufacturer’s stated temperature and humidity range.
- Storage outside the manufacturer’s stated temperature and humidity range.
- Mechanical shock (for example, drop test) or degraded sensor.
- Patient temperature is below ambient temperature.
*Portable and mobile RF communications can affect the device. The device needs special pre-cautions
regarding EMC according to the EMC information provided in the accompany documents.
*Do not use the devices in the MR environment.
beep for approximately 10 seconds. The measured reading will appear on the LCD
simultaneously. Th e min imu m measurement time until the signaling tone (beep) must be
maintained without exception.The temperature will enter the state of maximum update
after the buzzer notification. So that in order to achieve better body temperature
measurement result, recommend to keep the probe in mouth and rectum about 2 minutes,
or in armpit about 5 minutes regardless of the beep sound.
4. To prolong battery life, press the On/Off Button to turn unit off after testing is complete
. If no action
is taken, the unit will automatically shut off after around 15 minutes.
5. Store the thermometer in its protective case.
3. The degree sign flashes throughout the testing process. When flashing stops an alarm will
*Note: Normally Alarm b eeps m ore ra pidl y w hen te mperature
reaches 37.8 (100.0 ) or higher ,and t
the buzzes are“ Bi-Bi-Bi- B i-”;
℃ ℉ he buzzesare“ Bi-Bi-Bi----- Bi-Bi-Bi------- Bi-Bi-Bi”
Figure 4
LIMITED WARRANTY
The thermometer is guaranteed for one year from the date of purchase. If the thermometer does not
function properly due to defective components or poor workmanship, we will repair or replace it free of
charge. All components are covered by this warranty excluding the battery. The warranty does not cover
damages to your t
hermometer due to improper handling. To obtain warranty service, an original or copy
of the sales receipt from the original retailer is required.
CLEANING AND DISINFECTION
2)Using a clean, soft cloth to wipe the thermometer down to remove any residue;
3)Repeat step 1 and 2 for three times until no soil is seen with visual inspection after cleaning;
4)For thoroughly clean and disinfection, please use method A or B:
Method A(High level disinfection): immerse the thermometer probe in 0.55% OPA(O-Phthaldehyde),
such as CIDEX OPA, for at least 12 minutes under temperature at 20℃(68℉) ;
Method B(Low level disinfection): Using a clean soft cloth dipped in 70% medical alcohol, wipe the probe
3 times, at least on
e minute for each time.
5)Repeat step 1 to 3 to remove OPA residuals;
Note1: Rectal use is not recommended for home use as OPA will not be readily available outside of a hospital.
If rectal measurement is necessary, we strongly recommend high level disinfection.
Note2: Please operate according to the manual of OPA for reference.
To prevent damage to the thermometer please note and observe the following:
-Do not use benzene, paint thinner, gasoline or other strong solvents to clean the thermometer.
-Do not attempt to disinfect the sensing probe (tip) of the thermometer by immer
sing in alcohol, OPA
or in hot water (water over 50℃(122℉)) for long time.
-Do not use ultrasonic washing to clean the thermometer.
1)Immerse the thermometer probe in distilled water for at least 1 minute;
Average measure time: 20 seconds
BATTERY REPLACEMENT
1. Replace battery when the symbol“ ”in the lower right corner of the LCD display starts flashing.
2. Pull battery cover off as shown in Figure 5.
3. Gently pull out plastic circuit board with battery chamber approximately 1 cm (slightly less than1/2
".)
(See Figure 6)
4. Use pointed object such as a pen to remove old battery. Discard battery lawfully. Replace with new
1.5V DC button type LR41 or SR41,UCC392, or equivalent. Be sure battery is installed with “+”
polarity facing up. (See Figure 7)
5. Slide battery chamber back into place and attach cover.
Note:
The following schematic diagram of battery replacement is from the back of the thermometer
TROUBLESHOOTING
Problem Solution
Error message
The system is not
functioning properly.
Unload the battery, wait for 1 minute and repower
it. If the message reappears, contact the retailer
for service.
Temperature taken is
lower than 32.0°C(90.0°F)
Turn off, wait one minute and take a new temperature
via close contact and sufficient rest.
Temperature taken is
higher than 43.9°C(111.9°F)
Dead battery: Battery icon is
flashing, can’t be measurable.
Replace the battery.
Turn off, wait one minute and take a new temperature
via close contact and sufficient rest.
DIRECTIONS
After showing the , the thermometer will enter into the testing mode(See
Figure 3).
1. Press the On/Off Button next to LCD display. A tone will sound as the screen shows(See Figure 2).
last recorded temperature
2. Position thermometer in desired location (mouth, rectum, or armpit.)
a) Oral Use: Place thermometer under tongue as indicated by
position shown in Figure 4. Close your mouth and breathe evenly
through the nose to prevent the measurement from being inf
luenced
by inhaled/exhaled air.
b) Rectal Use: Lubricate silver probe tip with petroleum jelly for easy insertion.
Gently insert sensor approximately 1cm (less than 1/2 ) into rectum.
c) Armpit Use: Wipe armpi t dry. Place probe in armpit and keep arm pressed firmly
at side. From a medical viewpoint, this method will always provide inaccurate
readings, and should not be used if precise measurements are required.
“√ ”
"
PRODUCT ILLUSTRATION
Clinical accuracy
Clinical bias
Clinical repeatability
Limits of agreement
-0.21℃ -0.20℃
0. 04℃
0. 52℃
0. 08
0. 47℃
0. 09
0. 38℃
0. 08
Oral Use
Rectal Use
Armpit Use
OWNER S M ANUAL
’
Instant Flexible Digital Thermometer
Model:DMT-4333p
Battery Cap
On/Off Button
LCD
Probe
Figure 1
IP 27
Approx. 12 grams including battery
13.9cm×2.2cm×1.2cm(L×W×H)
Document No.: -108
Article No.: 001
Version: A
Date of Issue: 2021.04
JDMT-5204
Figure 2
Figure 3
Figure 6 Figure 7Figure 5
Shanghai International Holding Corp.GmbH(Europe) Eiffestrasse 80, 20537
Hamburg, Germany
EC REP
Disposal of this product and used batteries should be carried out
in accordance with the national regulations forthe disposal of
electronic products.
JOYTECH Healthcare Co., Ltd.
No.365, Wuzhou Road,311100 Hangzhou, Zhejiang Province,PEOPLE'S REPUBLIC OF CHINA
Tel:+86-571-81957767
0123
The product is in compliance with the requirements
of MDR(EU)2017/745,"0123" is the identification
number of notify body.
Importer:
Warning :
Read instructions thoroughly before using digital thermometer.
Choking Hazard: Thermometer cap and battery may be fatal if swallowed. Do not allow children
to use this device without parental supervision.
Do not use thermometer in ear. Designed use is for oral, rectal, and armpit (axilla) readings only.
Do not place thermometer battery near extreme heat as it may explode.
Remove battery from the device when not in operation for a long time.
The use of temperature readings for self-diagnosis is dangerous. Consult your doctor for the
interpretation of results. Self
-diagnosis may lead to the worsening of existing disease conditions.
Do not attempt measurements when the thermometer is wet as inaccurate readings may result.
Do not bite the thermometer. Doing so may lead to breakage and/or injury.
Do not attempt to disassemble or repair the thermometer. Doing so may result in inaccurate readings.
After each use, disinfect the thermometer especially in case the device is used by more than one person.
Do not force the thermometer into the rectum. Stop insertion and abort the measurement when pain is
present. Failure to do so may lead to injury.
Do no
t use thermometer orally after being used rectally.
For children who are two years old or younger, please do not use the devices orally.
If the unit has been stored at temperatures over 5℃ ~40℃(41℉ ~104℉) , leave it in 5℃ ~40℃
(41℉ ~104℉) ambient temperature for about 15 minutes before using it.
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.
PORTABLE RF communications eq
uipment (including peripherals such as antenna cables and external
antennas)should be used no closer than 30 cm (12 inches) to any part of the [ME EQUIPMENT or ME
SYSTEM],including cables specified by the MANUFACTURER. Otherwise, degradation of the
performance of this equipment could result.
It is not intended for use in the oxygen rich environment and presence of flammable anesthetic mixture
with air, oxygen or nitrous oxide.
Do not put the thermometer in direct sunlight or with cotton wool, otherwise the accuracy will be affected.
ME equipment should not be cleane
d and disinfected while in use.
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/ or patient
is established.
INTENDED USE
INTENDED USER/INDICATION FOR USE
Patient or healthy people who want to measure their body temperature, and medical workers who want to
measure the patient's body temperature.
Patient target group :Patients or healthy people who need or want to have their temperature taken.
The digital thermometers are intended to measure the human body temperature in regular mode orally, rectally and
under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under
8 years old with adult supervision.
SYMBOL EXPLANATION
IP27
Authorized representative in the European Community
The first num.2:Protected against solid foreign objects of 12.5 mm and greater. The second num.7:Protected
against the effects of temporary immersion in water.
General symbol for
recovery/ recyclable
106kPa
70kPa
Atmospheric pressure limitation
Storage and Transportation Humidity limitation: 15%~95%RH
Caution
Batch Code
Refer to instruction
manual/ booklet
Manufacturer
Date of manufacture
Disposal of this product and used batteries should
be carried out in accordance with the national
regulations for the disposal of electronic products.
TYPE BF APPLIED PART
95%
15%
Medical Device
EC REP
CE conformity marking 0123 represent
Notified Body identification number
01 2 3
Storage and Transportation Temperature Limit: -20℃~55℃(-4℉~131℉)
-20℃
55℃
MR Unsafe
CALIBRATION
The thermometer is initially calibrated at the time of manufacture. If the thermometer is used according to
the use instruction, periodic readjustment is not required. However, we recommend checking calibration
every two years or whenever clinical accuracy of the thermometer is in question.
water bath Turn on the thermometer and
insert into the water bath and then check the laboratory accuracy of thermometer. Repeat the
previous measurement process after it is stable for 10 minutes.
Please send the complete device to the dealers or manufacturer.
The above recommendations do not supersede the legal requirements. The user must always comply with
legal requirements for the control of the measurement, functionality, and accuracy of the device which
are required by the scope of relevant laws, directives or ordinances where the device is used.
Set the temperature of
the high-precision temperature bath to 33.00℃,37.00℃,42.00℃.
high-precision
Contraindication:
No contraindication
body temperature. Predictive-read thermometers are quicker than actual read thermometer.
Therefore, users only need about 20 seconds to take the temperature readings. Due to measurement
sites of predict thermometer are different, the reading time also may be different, but most people's
actual time is usually between 12 and 30 seconds.
The predictive digital thermometer provides a quick and highly accurate reading of an individual's
ISO 80601-2-56 Medical electrical equipment —Part 2-56:Particular requirements for basic
safety and essential p
erformance of clinical thermometers for body temperature measurement,
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 the home healthcare environment and
complies with the requirements of EN 60601-1-2(EMC), IEC/EN60601-1(Safety) standards.
And the manufacturer is ISO 13485 certified.
This appliance conforms to the following standards:
1. Mätsond
2. Display
3. På/av-knapp
4. Batterilucka
INTRODUKTION
Denna digitala termometer är avsedd att mäta den
mänskliga kroppstemperaturen i följande lägen; oralt,
rektalt och under armen. Enheten är återanvändbar
för klinisk användning eller för hemmabruk på männ-
iskor i alla åldrar, inklusive barn under 8 år under
tillsyn av en vuxen person.
SÄKERHETSFÖRESKRIFTER
• Termometern kan inte ersätta konsultation med
läkare.
• Läs denna manual noga innan termometern
används.
• Kvävningsrisk, termometerns lucka och batteri
kan innebära livsfara. Termometern förvaras utom
räckhåll för barn.
• Termometern ska inte användas av barn utan
vuxens överinseende.
• Använd inte termometern i utrymmen med hög
störningsnivå
• Vänta 30 minuter med febermätning efter träning,
dusch eller måltid.
• Termometerns prestanda bör kontrolleras vartan-
nat år.
• Utsätt aldrig termometern för direkt solljus.
• Mät temperaturen vid samma tidpunkt på dygnet
för korrekt jämförelse av mätvärde.
• Tappa inte termometern och utsätt den inte för
kraftiga slag. Den är inte slagtålig.
• Koka inte termometern, utan rengör den med en
trasa och sterilisera den sedan med desinfek-
tionsmedel.
• Låt inte termometern komma i kontakt med thin-
ner eller andra kemiska lösningsmedel.
• Förvara inte termometern i direkt solljus eller
vid hög temperatur, inte heller i en fuktig eller
dammig miljö. Felaktig förvaring kan ge sämre
funktion.
• Ta inte isär termometern, utom när batteriet ska
bytas.
Produktspezifikationen
Marke: | Biltema |
Kategorie: | Thermometer |
Modell: | 84-177 |
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