Microlife MT0PC1 Microlife Bluetooth Patch Thermometer User Manual OBJ BUCH 470 001
Microlife Corporation Microlife Bluetooth Patch Thermometer OBJ BUCH 470 001
user manual
IB PT 200 EN 4818
Distributed by:
Microlife USA, Inc.
1617 Gulf to Bay Blvd.,Floor 2
Clearwater, FL 33755，UNITED STATES
Toll Free Help Line:1-800-568-4147
www.microlifeusa.com
Made in China
Microlife PT 200
1 2
3
PT200
Bluetooth®
Patch Thermometer
10 x
PT 200Guarantee Card
Name of Purchaser / Nom de l'acheteur / Nome del
rivenditore / Name des Käufers / Alıcının adı /
Nombre del comprador / Nome do comprador /
Naam koper / Ονοματεπώνυμο αγοραστή /
/
Serial Number / Numéro de série / Numero di serie
/ Serien-Nr. / Seri numarası / Número de serie /
Número de série / Serienummer / Αριθμός σειράς /
/
Date of Purchase / Date d'achat / Data d’acquisto /
Kaufdatum / Satın alma tarihi / Fecha de compra /
Data da compra / Datum van aankoop / Ημερομηνία
αγοράς / /
Specialist Dealer / Revendeur / Categoria riven-
ditore / Fachhändler / Uzman satıcı / Distribuidor
especializado / Revendedor autorizado / Specialist
Dealer / Εξειδικευμένος αντιπρόσωποςa /
/
BP W100 ١٢ AR
ﺔﻟﺎﻔﻜﻟا ﺔﻗﺎﻄﺑ
(ﻲﻔﻠﺨﻟا ءﺎﻄﻐﻟا ﺮﻈﻧا) ﺔﻟﺎﻔﻜﻟا ﺔﻗﺎﻄﺑ
:يﺮﺘﺸﻤﻟا ﻢﺳا
:ﻞﻳدﻮﻤﻟا
:ﻞﺴﻠﺴﺘﻟا ﻢﻗر
:ءاﺮﺸﻟا ﺦﻳرﺎﺗ
:ﺺﺘﺨﻤﻟا ﺮﺟﺎﺘﻟا
BP W100 ١٢ AR
ﺔﻟﺎﻔﻜﻟا ﺔﻗﺎﻄﺑ
(ﻲﻔﻠﺨﻟا ءﺎﻄﻐﻟا ﺮﻈﻧا) ﺔﻟﺎﻔﻜﻟا ﺔﻗﺎﻄﺑ
:يﺮﺘﺸﻤﻟا ﻢﺳا
:ﻞﻳدﻮﻤﻟا
:ﻞﺴﻠﺴﺘﻟا ﻢﻗر
:ءاﺮﺸﻟا ﺦﻳرﺎﺗ
:ﺺﺘﺨﻤﻟا ﺮﺟﺎﺘﻟا
BP W100 ١٢ AR
ﺔﻟﺎﻔﻜﻟا ﺔﻗﺎﻄﺑ
(ﻲﻔﻠﺨﻟا ءﺎﻄﻐﻟا ﺮﻈﻧا) ﺔﻟﺎﻔﻜﻟا ﺔﻗﺎﻄﺑ
:يﺮﺘﺸﻤﻟا ﻢﺳا
:ﻞﻳدﻮﻤﻟا
:ﻞﺴﻠﺴﺘﻟا ﻢﻗر
:ءاﺮﺸﻟا ﺦﻳرﺎﺗ
:ﺺﺘﺨﻤﻟا ﺮﺟﺎﺘﻟا
BP W100 ١٢ AR
ﺔﻟﺎﻔﻜﻟا ﺔﻗﺎﻄﺑ
(ﻲﻔﻠﺨﻟا ءﺎﻄﻐﻟا ﺮﻈﻧا) ﺔﻟﺎﻔﻜﻟا ﺔﻗﺎﻄﺑ
:يﺮﺘﺸﻤﻟا ﻢﺳا
:ﻞﻳدﻮﻤﻟا
:ﻞﺴﻠﺴﺘﻟا ﻢﻗر
:ءاﺮﺸﻟا ﺦﻳرﺎﺗ
:ﺺﺘﺨﻤﻟا ﺮﺟﺎﺘﻟا
FA
FA
FA
FA
Microlife PT 200
+
2
3
4
6
5
7
1
1
Read the instructions carefully before using this device.
Type BF applied part
This Microlife thermometer is a high quality product incorporating
the latest technology and tested in accordance with international
standards. With its unique technology, this device can provide a
stable, heat-interference-free reading with each measurement.
The device performs a self-test every time it is switched on to
always guarantee the specified accuracy of any measurement.
This Microlife thermometer is intended for the periodic measure-
ment and monitoring of human body temperature.
This thermometer has been clinically tested and proven to be
safe and accurate when used in accordance to the operating
instruction manual.
Please read through these instructions carefully in order for you to
understand all functions and safety information.
Indications for Use
The device is used for the periodic measurement and monitoring
of human body temperature in the axilla for the adults, children
and neonates, the device to be used by average consumers and
healthcare professionals in both home and clinical
environments, the test data can be transferred and stored in the
APP by BT transmission.
Table of Contents
1. The Advantages of this Thermometer
• Accurate and reliable
•Safe, hygienic and biocompatible
•High temperature alarm
•Bluetooth® Function
2. Important Safety Instructions
3. Using the Device for the First Time
• Downloading the «Microlife Thermo 24» App
• Connecting the «Microlife Thermo 24» App
•App Tutorial
4. Measuring the body temperature
5. Monitoring the body temperature
6. Cleaning and Disinfecting
7. Battery Replacement
8. Guarantee
9. Technical Specifications
10. www.microlife.com
Guarantee Card (see Back Cover)
1. The Advantages of this Thermometer
Accurate and reliable
The unique assembly construction incorporates an advanced
sensor, ensuring an accurate and reliable measurement.
A measurement is taken every 5 seconds and transferred to the App.
Safe, hygienic and biocompatible
No risk of broken glass or mercury ingestion.
Completely safe for use on children.
The adhesive patches included are 100% biocompatible and do
not harm the skin cells.
Cleaning of the device can be done with an alcohol-moistened
cotton tissue, making this thermometer completely hygienic for
use by the whole family.
High temperature alarm
Continuous beeps (until the user acknowledges the alert) on the
«Microlife Thermo 24» App, alert that the body temperature is equal
to or higher than 37.5 °C. The default High temperature alarm
setting is 37.5 °C. Users can also set alarm points for high and low
temperatures indi-vidually. So when the temperature exceeds these
limits, the colour of
Microlife Bluetooth® Patch Thermometer PT 200 EN
1Measuring sensor
2ON/OFF button
3Power indicator
4Battery Compartment
5How to insert the battery
6Preparing the device for use
7Correct positioning of the device
2PT 200 EN
the displayed circle will turn red (high temperature) or blue (low
temperature) and an alarm beep will be triggered. Please consult with
your doctor if you do not know the appropriate body temperature.
Bluetooth® Function
This device connects to the «Microlife Thermo 24» App by using
Bluetooth® 4.0 and enables easy monitoring of temperature.
2. Important Safety Instructions
Follow instructions for use. This document provides important
product operation and safety information regarding this device.
Please read this document thoroughly before using the device
and keep for future reference.
This device may only be used for the purposes described in
these instructions. The manufacturer cannot be held liable for
damage caused by incorrect application.
This device only works in conjunction with a smartphone or
tablet as described in these instructions.
This device comprises sensitive components and must be
treated with caution. Observe the storage and operating condi-
tions described in the «Technical Specifications» section.
Do not scratch or press the measuring sensor.
Do not use this device if you think it is damaged or notice
anything unusual.
Never open this device.
Never immerse this device in water or other liquids. For
cleaning please follow the instructions in the «Cleaning
and Disinfecting» section.
The adhesive patches are for single use only – do not use them
repeatedly. Only use them in smooth and undamaged condition.
If the measurement result is not consistent with the patient's
finding or unusually low, double check the result by another
core body temperature measurement.
Ensure that children do not use this device unsupervised; some
parts are small enough to be swallowed.
Do not use this device close to strong electromagnetic fields.
Keep a minimum distance of 3.3 m when using this device.
Protect it from:
- extreme temperatures
- impact and dropping
- contamination and dust
- direct sunlight
- heat and cold
If the device is not going to be used for a prolonged period the
battery should be removed.
Read the additional safety information provided within the indi-
vidual sections of this instruction manual.
WARNING:
The measurement results given by this device is
not a diagnosis. It is not replacing the need for the consultation
of a physician, especially if not matching the patient’s symp-
toms. Do not rely on the measurement result only, always
consider other potentially occurring symptoms and the
patient’s feedback. Calling a doctor or an ambulance is
advised if needed.
3. Using the Device for the First Time
Insert the battery as described in chapter «Battery Replacement».
Downloading the «Microlife Thermo 24» App
Download «Microlife Thermo 24» App for free from Google Play™
(Android) or App Store (iOS) and install it on your smartphone.
Connecting the «Microlife Thermo 24» App
1. Activate Bluetooth® on your smartphone.
2. Press and hold the ON/OFF button 2 for at least 3 seconds
until the power indicator 3 flashes green 3 times to activate the
Bluetooth® on the device.
3. Start the «Microlife Thermo 24» App on the smartphone and
create a profile, to establish a connection between the device and
the smartphone. A temperature display will appear on the smart-
phone, when a successful connection has been established.
Create different profiles for various patients, so they can be
tracked separately.
We recommend to activate the flight mode on the smart-
phone, while Bluetooth® is activated, to avoid disturbances
of the connection by phone calls.
App Tutorial
To access the tutorial, select «Help & About» in the menu of the
«Microlife Thermo 24» App (located in the upper left corner on the
screen) and press «Tutorial».
4. Measuring the body temperature
1. The device and the patient must remain in a stable environment
for at least 5 minutes before measuring the temperature.
2. Clean the armpit and the surrounding area.
3
3. Take one adhesive patch, remove the protective film and place
the device right in the middle of the patch 6. The battery
compartment 4 side should be stuck on the patch. The
measuring sensor 1 needs to be in contact with the skin and
as close as possible to the armpit.
4. Place the device with the adhesive patch directly on the skin
below the armpit 7.
5. Lower the arm and wait around
15
minutes until the temperature
rises to the body temperature level.
6. The temperature display will appear on the smartphone.
7. Press and hold the ON/OFF button 2 for 3 seconds to turn off
the device; otherwise the device will automatically switch off
after approx. 30 minutes, when removed from the body.
To keep a good connection, avoid distances above 5 m
between the device and the smartphone.
Obstacles (e.g. walls) may weaken the connection.
NOTE:
Regularly check for sufficient skin contact of the device, in order
to avoid measurement errors.
Sudden movements or low battery power may lead to inaccu-
rate measurement results.
The adhesive patches are for single use only – do not use them
repeatedly. Only use them in smooth and undamaged condition.
Don't use the thermometer in high humidity environments.
Doctors recommend rectal measurement for newborn infants
within the first 6 months, as all other measuring methods might
lead to ambiguous results.
Readings from different measuring sites should not be
compared as the normal body temperature varies by
measuring site and time of day, being highest in the evening
and lowest about one hour before waking up.
Normal body temperature ranges:
- Axillar: 34.7 - 37.3 °C / 94.5 - 99.1 °F
- Oral: 35.5 - 37.5 °C / 95.9 - 99.5 °F
- Rectal: 36.6 - 38.0 °C / 97.9 - 100.4 °F
- Microlife PT 200: 34.7 - 37.3 °C / 94.5 - 99.1 °F
5. Monitoring the body temperature
Monitor the body temperature for up to 72 hours, once the device
is connected to the App. A measurement is taken every 5 seconds
and transferred to the App. You can also track the temperature
trend of the past hours and the data of previous measurements.
If the device is disconnected from the App, the device will
save one measurement every minute and send the stored
results to the App, once Bluetooth® is connected again.
6. Cleaning and Disinfecting
Use an alcohol swab or cotton tissue moistened with alcohol (70%
Isopropyl) to clean the thermometer casing and the measuring
sensor. Ensure that no liquid enters the interior of the device.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the device in water or other cleaning
liquids. Take care not to scratch the measuring sensor.
7. Battery Replacement
This device is supplied with one lithium battery type CR2032. The
battery needs replacing, when the power indicator 3 is blinking
red and a notification on the smartphone App is shown.
Remove the battery cover 4 by using a coin and rotate clockwise
to open. Insert the new battery with the + at the top 5. Then posi-
tion the battery cover and rotate it counterclockwise to close.
Batteries and electronic devices must be disposed of in
accordance with the locally applicable regulations, not with
domestic waste.
8. Guarantee
This device is covered by a 5 year guarantee from the date of
purchase. The guarantee is valid only on presentation of the guar-
antee card completed by the dealer (see back) confirming date of
purchase or the receipt.
The guarantee covers the device. The battery and packaging
are not included.
Opening or altering the device invalidates the guarantee.
The guarantee does not cover damage caused by improper
handling, a discharged battery, accidents or non-compliance
with the operating instructions.
Please contact Microlife-service.
4
PT 200 EN
9. Technical Specifications
10. www.microlife.com
This equipment generates uses and can radiate radio frequency
energy and, if not used in accordance with the instructions, may
cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be
determined by turning the equipment on and off, the user is
encouraged to try to correct the interference by increasing the
distance between the product and the affected device,can by
one or more of the following measures
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
– Consult the dealer or an experienced radio/TV technician for
help.
This device complies with FCC radiation exposure limits set
forth for an uncontrolled environment. End users must follow the
specific operating instructions for satisfying RF exposure
compliance. This transmitter must not be co-located or operating
in conjunction with any other antenna or transmitter.
Electromagnetic compatibility: This device fulfills the stipulations
of the standard IEC 60601-1-2 (EMC).
Technical alterations reserved.
According to the Medical Product User Act a biennial technical
inspection is recommended for professional users. Please
observe the applicable disposal regulations.
The Bluetooth
®
word mark and logos are registered trademarks
owned by Bluetooth SIG, Inc. and any use of such marks by Microlife
Corp. is under license. Other trademarks and trade names are those
of their respective owners.
Portable and mobile RF communications equipment can affect the
device
NOTE: Do not use this device in the presence of electromagnetic
or other interference outside the normal range specified in
IEC60601-1-2.
Type:
Patch Thermometer PT 200
Measurement Operation
: Direct Mode
Measurement range:
32.0 - 43.0 °C / 89.6 - 109.4 °F
Resolution:
0.1 °C / °F
Measurement
accuracy:
Laboratory:
± 0.1 °C / ± 0.2 °F
Memory:
4320 readings if not linked to the smartphone
Operating
conditions:
10 - 40 °C / 50 - 104 °F
15-95 % relative maximum humidity
Storage conditions:
-25 - +60 °C / -13 - +140 °F
15-95 % relative maximum humidity
Automatic
Switch-off:
Automatic switch off after 30 minutes, when
removed from the body.
Communication:
Bluetooth
®
4.0
10 m valid transmission distance in free space
Compatibility:
iOS: iOS 8.0 or newer
Android: Android 5.0 or newer
Battery:
1 x CR2032 battery 3V
Battery lifetime:
approx. 9 days when used 8 hours per day
Dimensions:
Weight:
IP Class:
Reference to
standards:
Expected
service life:
(using a new battery)
53 x 31.5 x 8
mm
11 g (with battery), 8 g (w/o battery)
IP22
ISO80601-2-56, ASTM E1112; IEC 60601-1
;
IEC 60601-1-2 (EMC); IEC 60601-1-11
5 years
Detailed user information about our thermometers and
blood pressure monitors as well as services can be found
at www.microlife.com.
This device complies with part 15 of the FCC Rules. Operation is
subject to the following two condition s: (1) This device may not
cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation. Changes or modifications to the product are not
approved by Microlife USA and could void the user's authority to
operate the equipment under FCC jurisdiction.
Note:This equipment has been verified to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules.These
limits are designed to provide reasonable protection.against harmful
interference in a residential installation.
5
Appendix
Guidance and manufacturer’s declaration – electromagnetic emissions
The model PT 200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the model PT 200 should assure that it is used in such an environment.
Emissions
Compliance
Electromagnetic environment-- guidance
RF emissions
CISPR 11
Group 1
The model PT 200 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
The model PT 200 is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
N/A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
N/A
6
1.
Guidance and manufacturer’s declaration – electromagnetic immunity
The model PT 200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the model PT 200 should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment
--guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines and
patient coupled
lines
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s)
and neutral
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5s
N/A
Mains power quality should be
that of a typical commercial or
hospital environment. If a dips or
an interruption of mains power
occurs, the current of the model
PT 200 may be dropped off from
normal level, it may be necessary
to use uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level
7
2.
Guidance and manufacturer’s declaration – electromagnetic immunity
The model PT 200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the model PT 200 should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
N/A
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the model
PT 200, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
Distance in metres (m).b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
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.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the model PT 200 is used exceeds the applicable RF compliance
level above, the model PT 200 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the model PT 200.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
8
3.
Recommended separation distances between
portable and mobile RF communications equipment and the model PT 200
The model PT 200 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the model PT 200 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the model PT 200 as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
/
0.12
0.23
0.1
/
0.38
0.73
1
/
1.2
2.3
10
/
3.8
7.3
100
/
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.