Mediblink M372 Gebrauchsanweisungen

Mediblink Digital thermometer M372
EN
INSTRUCTIONS FOR USE
PLEASE READ CAREFULLY BEFORE USE
Mediblink Digital thermometer M372 provides a quick and highly accurate reading of an indi-
vidual's body temperature. To better understand its functions and to provide years of dependable
results, please read all instructions for use first.
Content: 1 Digital thermometer, 1 User's Manual, 1 Storage Case
INTENDED USE
The digital thermometers are intended to measure the human body temperature in regular mode
orally, rectally, under the arm. The devices are reusable for clinical or home use for people of all
ages, including children under 8 years old with adult supervision.
INTENDED USER/INDICATION FOR USE
Patients 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 measured.
PRODUCT ILLUSTRATION
Probe
Figure 1: Digital thermometer components
SPECIFICATIONS
Product name: Mediblink Digital thermometer M372
Type: Digital thermometer (Not Predictive)
Reference number /
Model:
M372 / DMT-2032
Measure Range:
32.0°C-42.9°C (90.0°F-109.9°F) (°C/°F chosen by manufacturer)
Accuracy:
±0.1°C (±0.2°F) during 35.5°C~42.0°C (95.9°F~107.6°F) at
18°C~28°C (64.4°F~82.4°F) ambient operating range, ±0.2°C
(±0.4°F) for other measuring and ambient operating range
Operating mode: Direct Mode
Display: Liquid crystal display, 3 1/2 digits
Memory:
For storing the last measured value
Battery:
One 1.5 V DC button battery (size LR41 or SR41, UCC 392)
Battery life:
Approx. 200 hours of continuous operation or 1 year with 3
measurements per day
Dimension: 13.8 × 2.2 × 1.2 cm (L × W × H)
Weight: Approx. 12 grams including battery
Expected service life: Three years
Ambient operating
Temperature: 5°C~40°C (41°F~104°F) Relative humidity:
range:
15%~95% RH Atmospheric Pressure: 700 hPa~1060 hPa
Storage and
Temperature: -20°C~55°C (-4°F~131°F) Relative humidity:
transportation condition: 15%~95% RH Atmospheric Pressure: 700 hPa~1060 hPa
Ingress Protection
Rating: IP 27
Classification: Type BF
Contraindications: No contraindications
Conforming to
ISO 80601-2-56 Medical electrical equipment – Part 2-56:
standards:
Particular requirements for basic safety and essential performance 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.
PRECAUTIONS
1. 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.
2. Portable and mobile RF communications can affect the device. The device needs special pre-cau-
tions regarding EMC according to the EMC information provided in the accompany documents.
WARNINGS
• Read instructions thoroughly before using digital thermometer.
• Choking Hazard: Thermometer cover and battery may be fatal if swallowed. Do not allow chil-
dren 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 in-
terpretation 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 not 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°C~40°C (41°F~104°F), leave it in 5°C~40°C
(41°F~104°F) 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 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 [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 anaesthetic
mixture with air, oxygen or nitrous oxide.
• Do not put the thermometer in direct sunlight or in cotton wool, otherwise the accuracy will be affected.
• ME equipment should not be cleaned and disinfected while in use.
˚C/˚F SWITCHABLE
Temperature readings are available in the Celsius scale (°C/°F; 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.
DIRECTIONS FOR USE
1. Press the On/Off Button next to LCD display in Figure 1. A tone will sound as the screen shows
, followed by last recorded temperature. After showing the self-test temperature, the
M
thermometer is now in the testing mode.
2. Position thermometer in desired location
(mouth, rectum, or armpit.)
a) Oral Use: Place thermometer under tongue as
indicated by " " position shown in Figure 2.
Close your mouth and breathe evenly through
the nose to prevent the measurement from
being influenced 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 armpit 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.
3. The degree sign flashes throughout the testing process. When flashing stops an alarm will beep
for approximately 10 seconds. The measured reading will appear on the LCD simultaneously.
The minimum measurement time until the signalling tone (beep) must be maintained without
exception. The measurement continues even after the buzzer notification.
IMPORTANT: in order to achieve better body temperature measurement result,
it is recommended to keep the probe in mouth and rectum about 2 minutes, or
in armpit about 5 minutes regardless of the beep sound and at least 30 seconds
measurement interval should be maintained.
* Note: Normally the buzzes are "Bi-Bi-Bi- Bi-"; alarm beeps more rapidly when temperature reaches 37.8°C
(100°F) or higher and the buzzers are "Bi-Bi-Bi----- Bi-Bi-Bi------- Bi-Bi-Bi".
Battery Cover
LCD
On/Off Button
Figure 2
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 10 minutes.
TROUBLESHOOTING
Error Problem
message
Temperature taken is lower
than 32.0°C (90.0°F)
Temperature taken is higher
than 42.9°C (109.9°F)
The system is not functioning
properly.
Dead battery: Battery icon is
flashing, can't measure.
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 3.
3. Gently pull-out plastic circuit board with battery chamber approximately 1cm (slightly less
than 1/2'') (Figure 4).
4. Use pointed object such as a pen to remove old battery. Discard battery lawfully. Replace with
new 1.5 V DC button type LR41 or SR41, UCC392, or equivalent. Be sure battery is installed with
polarity facing up (Figure 5).
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.
Figure 3 Figure 4
CALIBRATION
The thermometer is initially calibrated at the time of manufacture. If the thermometer is used ac-
cording to the instruction of use, periodic readjustment is not required. However, we recommend
checking calibration every two years or whenever clinical accuracy of the thermometer is in ques-
tion. Set the temperature of the high-precision water bath temperature bath to 33.00°C, 37.00°C,
42.00°C. Turn on the thermometer and insert into the high-precision 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.
CLEANING AND DISINFECTION
1. Pre-clean the surface of the thermometer probe using potable water or wipe it with a clean,
soft cloth dampened with potable water to remove surface dirt.
2. Immerse the thermometer probe completely in high-purity water for at least 1 minute.
3. Gently wipe the thermometer with a dry, clean, soft cloth to remove any residue.
4. Repeat steps 2 and 3 three times until no dirt is visible upon visual inspection after cleaning.
5. Disinfect the probe:
• After use in the armpit, mouth, or rectum:
Method A (High-level disinfection): Immerse the thermometer probe in 0.55% OPA
(Ortho-phthalaldehyde), such as CIDEX OPA, for at least 12 minutes at 20°C (68°F).
Use this method before oral or rectal use.
Method B (Intermediate disinfection): Using a clean soft cloth dipped in 70%
isopropanol, wipe the probe three times, for at least one minute each time.
6. Repeat steps 2 to 4 to remove any disinfectant residue.
7. After cleaning and disinfection are complete, check that the product appears normal. Then,
place the thermometer in its dust cover (if available) and store it in a cool, dry, clean environ-
ment, away from high temperatures and corrosive substances.
Precautions:
1. The device must be cleaned and disinfected before and after each use.
2. For oral or rectal measurements, advanced disinfection is strongly recommended.
3. For the disinfectants or cleaning agents mentioned above, always follow the manufacturers'
instructions.
4. The water temperature used in any of the above processes should not exceed 45°C (113°F).
5. Do not use benzene, paint thinner, gasoline, or other strong solvents to clean the thermometer.
6. Do not attempt to disinfect the sensing probe (tip) of the thermometer by immersing it in 70%
isopropanol, OPA, or hot water (above 45°C / 113°F) for extended periods.
7. Do not use ultrasound or any automatic/semi-automatic cleaning methods on the thermometer.
8. Do not use any disinfection methods other than the recommended ones. Unapproved methods
may cause permanent damage to the equipment.
9. During its service life, the product can be reused approximately 3,000 times if the above clean-
ing and disinfection procedures are followed.
ELECTROMAGNETIC COMPATIBILITY INFORMATION
The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The re-
quirements are satisfied under conditions described in the table below. The device is an electrical
medical product and is subject to special precautionary measures with regard to EMC which must
be published in the instructions for use. Portable and mobile HF communications equipment can
affect the device. Use of the unit in conjunction with non-approved accessories can affect the de-
vice negatively and alter the electromagnetic compatibility. The device should not be used directly
adjacent to or between other electrical equipment.
Electromagnetic Compatibility Information – electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Emission test
Conducted emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / flicker emissions IEC 61000-3-3
Electromagnetic Compatibility Information – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic discharge (ESD) IEC ±8 kV contact
61000-4-2
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Electrical transient/burst IEC ±2 kV for power supply lines
61000-4-4
100 kHz repetition frequency
±1 kV for input/output lines
Surge IEC 61000-4-5 ±0.5 kV, ±2 kV differential
mode line-line
Voltage dips, short interruptions 0% U
and voltage variations on power for 0.5 cycle at 0°, 45°, 90°,
supply input lines IEC 61000-4-11 135°, 180°, 225°, 270° and 315°
0% U
for 1 cycle at 0°
70% U
for 25/30 cycles at 0°
0% U
for 250/300 cycles at 0°
Power frequency (50/60 Hz) 30 A/m, 50/60 Hz
magnetic field IEC 61000-4-8
NOTE: U is the a. c. mains voltage prior to application of the test level.
T
Electromagnetic Compatibility Information – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Conducted RF IEC 61000-4-6 3 Vrms, 150 kHz to 80 MHz
6 Vrms, 150 kHz to 80 MHz
ISM bands
Radiated RF IEC 61000-4-3 10 V/m
80 MHz to 2.7 GHz
Proximity magnetic fields IEC 30 kHz, 8 A/m, CW 134.2 kHz,
61000-4-39 65 A/m, Pulse modulation 2.1 kHz
13.56 kHz, 7.5 A/m, CW 134.2
kHz, 65 A/m, Pulse modulation
50 kHz
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to
a
6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz,
5.3 MHz to 5.4 MHz, 7.0 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to
18.17 MHz, 21 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28 MHz to 29.7 MHz and 50 MHz to 54 MHz.
Solution
Turn off, wait one minute and take a
new temperature via close contact and
sufficient rest.
Turn off, wait one minute and take a
new temperature via close contact and
sufficient rest.
Unload the battery, wait for 1 minute
and repower it. If the message reappears,
contact the retailer for service.
Replace the battery.
Figure 5
Compliance
Not applicable
Group 1, Class B
Not applicable
Not applicable
Compliance level
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable
Not applicable
(100% dip in U ) Not applicable
T T
(100% dip in U )
T T
(30% dip in U )
T T
(100% dip in U )
T T
30 A/m, 50/60 Hz
Compliance level
Not applicable
10 V/m
30 kHz, 8 A/m, CW 134.2 kHz, 65
A/m, Pulse modulation 2.1 kHz
13.56 kHz, 7.5 A/m, CW 134.2
kHz, 65 A/m, Pulse modulation
50 kHz