Mediblink M377 Gebrauchsanweisungen

Mediblink Digital thermometer Duck M377
EN
INSTRUCTIONS FOR USE
PLEASE READ CAREFULLY BEFORE USE
Mediblink Digital thermometer Duck M377 provides a quick and highly accurate reading of an in-
dividual'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 Flexible Tip
Figure 1: Digital thermometer components
SPECIFICATIONS
Product name: Mediblink Digital thermometer Duck M377
Type: Digital thermometer (Not Predictive)
Reference number /
Model:
M377 / DMT-427
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:
14.4 x 2.5 x 2.1 cm (L x W x H)
Weight: Approx. 11 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.
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
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.
Battery Cover
LCD
On/Off Button
Figure 2
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"
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. Immerse the thermometer probe in distilled water for at least 1 minute.
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 thorough cleaning and disinfection, please use method A or B:
• Method A (High level disinfection): immerse the thermometer probe in 0.55% OPA
(O-Phthalaldehyde), such as CIDEX OPA, for at least 12 minutes under temperature at 20°C;
• Method B (Low level disinfection): Using a clean soft cloth dipped in 70% medical alcohol,
wipe the probe 3 times, at least one minute for each time.
5. Repeat step 1 to 3 to remove OPA residuals.
Note 1: 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.
Note 2: 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 immersing in alco-
hol, OPA or in hot water (water over 122°F/50°C) for long time.
• Do not use ultrasonic washing to clean the thermometer.
ELECTROMAGNETIC COMPATIBILITY INFORMATION
The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements
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 instruc-
tions 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 device 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.
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