WARMIE WM-1020 User manual
USER MANUAL
WARMIE
WM-1020
Temperature monitoring system
Poznan, 2020-11-16
ENG
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ENG
READ CAREFULLY THE ENTIRE USER
MANUAL, BECAUSE IT CONTAINS
INFORMATION THAT IS IMPORTANT FOR THE
USER
3
Spis treści
1 INTRODUCTION ��������������������������������������������������������������������������������������������������5
1.1 About this manual ............................................................................................... 5
1.2 Index of changes ................................................................................................. 6
1.3 Scope of application............................................................................................ 6
1.4 Symbols, markings and terms used in the manual.............................................. 6
2 PRODUCT CHARACTERISTICS����������������������������������������������������������������������������8
2.1 Intended use........................................................................................................ 8
2.2 Indications........................................................................................................... 8
2.3 Counterindications .............................................................................................. 8
2.4 Possible undesirable effects and product safety ................................................ 8
2.5 Precautions and warnings................................................................................... 9
2.6 Additional information....................................................................................... 11
2.7 Product classication........................................................................................ 12
2.8 Marking ............................................................................................................. 12
2.9 Product label ..................................................................................................... 14
2.10 Environmental working, storage and transport conditions ............................. 14
2.10.1 Working conditions....................................................................................... 14
2.10.2 Storage and transport conditions................................................................. 15
3 DESIGN AND OPERATION ��������������������������������������������������������������������������������� 15
3.1 Equipment ......................................................................................................... 15
4 INSTALLATION AND OPERATION OF THE PRODUCT����������������������������������������� 16
4.1 Supported operating systems of smartphones ................................................ 16
4.2 WARMIE24 application ..................................................................................... 17
4.3 Activation, deactivation of the connection – pairing of devices....................... 19
4.3.1 Activation of the connection – pairing of devices ......................................... 19
4.3.2 Deactivation of the connection....................................................................... 20
4.4 Placement of the sensor on the patient’s body................................................. 21
4.5Connection of the WARMIE sensor with the WARMIE24 app in the smartphone23
4.6 Measurement of temperature and collection of results ................................... 23
Contents
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ENG
4.7 User settings..................................................................................................... 24
4.7.1 Enable disconnection and connection notications ...................................... 26
4.7.2 Download measurements in the background ................................................ 26
4.7.3 Measurement settings................................................................................... 26
4.8 Measurement registration ................................................................................ 26
4.9 Measurement viewing ...................................................................................... 26
4.10 Temperature threshold settings ..................................................................... 27
4.11 Export of measurement results ...................................................................... 27
4.12 Deletion of measurements and deactivation of the connection..................... 28
5 NOTIFICATIONS�����������������������������������������������������������������������������������������������29
6 MAINTENANCE������������������������������������������������������������������������������������������������ 30
6.1 Cleaning and disinfection ................................................................................. 30
6.2 Battery replacement ......................................................................................... 30
7 TROUBLESHOOTING ���������������������������������������������������������������������������������������� 32
7.1 Failures, damage, contact with the service centre............................................ 32
7.2 Messages when the device is being switched on............................................. 33
7.2.1 Request for granting authorisations.............................................................. 33
7.2.2 Request for enabling Bluetooth on your mobile ............................................ 33
7.2.3 Information about the lack of connection ..................................................... 33
8 SPECIFICATION OF TECHNICAL PARAMETERS������������������������������������������������� 34
9 MANUFACTURER���������������������������������������������������������������������������������������������� 35
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1 INTRODUCTION
1.1 About this manual
This manual is an integral part of the WARMIE WM-1020 temperature
monitoring system.
WARMIE Sp. z o.o. shall not bear any liability nor grant any warranties in
connection with the damage (also indirect damage) which occurred as a consequence
of failure to observe this user manual.
• Before using the medical device, please read this manual carefully, paying par-
ticular attention to issues related to the product’s safety.
• Keep the manual in a safe place throughout the period of use of the device.
• The user manual must be delivered to each subsequent owner or user of the
device.
• This manual must be updated on the basis of every supplement received from
the manufacturer.
The aim of this manual is the description of a medical device, that is, the
WARMIE temperature measuring system, with a particular consideration of:
• the operation of the device in accordance with its intended use,
• the safety of use,
• the troubleshooting
• the maintenance and disposal.
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ENG
1.2 Index of changes
Table 1.1:
Version of the application Date of issue
1.5.X/Y 30 July 2020
1.3 Scope of application
This manual applies to the WARMIE temperature monitoring system, in
the version specied in table 1.1.
1.4 Symbols, markings and terms used in the manual
Warnings and safety measures, non-compliance with which may result
in personal harm, including serious injuries.
Warnings and safety measures, non-compliance with which may cause
damage to the device or its malfunctioning.
Guidelines or information useful to the user.
The meaning of the terms frequently used in this manual has been provided below
WARMIE System,
Medical device,
product
The system which is the subject of this manual, and which
consists of the WARMIE Sensor and the WARMIE24 appli-
cation delivered by the manufacturer and activated on the
user smartphone. This manual is also a part of the product.
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WARMIE sensor,
sensor,
device,
thermometer
An electronic device used to measure temperature and
to transmit the results into the WARMIE application. The
sensor is attached to the user’s body using a band. After
the sensor is activated, it transmits the temperature measu-
rement results to the WARMIE application
WARMIE appli-
cation,
WARMIE24,
application
The software that is used to collect, process and display
the results of measurements carried out by the WARMIE
Sensor. The software is downloaded from the GooglePlay
store / AppStore and installed on the user’s mobile phone.
The mobile phone must meet specic requirements.
activation A simple activity which is aimed at putting the WARMIE
Sensor into the state in which it performs measurements
and transmits the results to the WARMIE Application. The
sensor is delivered to the user in a non-active state and may
be activated and deactivated by the user. It may also deacti-
vate itself, if it is not in use for a longer period of time.
pairing A sequence of activities which creates a permanent
connection between a specic WARMIE Sensor and a
specic WARMIE24 application on the user’s smartphone.
The paired elements – the sensor and the application – are
capable of reconstructing the connection after it is broken,
e.g. because of the loss of coverage.
probe The metal element on the casing of the device, under which
there is a transmitter which measures the temperature.
manufacturer WARMIE Sp. z o.o.
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ENG
2 PRODUCT CHARACTERISTICS
2.1 Intended use
The WARMIE medical device is a battery-powered wireless thermometer
designed for the continuous measurement and monitoring of the human body tempe-
rature. The measured temperature value is transmitted wirelessly to the application
installed on a user’s smartphone, which enables the reading of the temperature and
the registration of its changes. The battery life allows for the continuous temperature
monitoring for many weeks.
2.2 Indications
An indication for using the product is:
a) monitoring of the body temperature:
• in the course of systemic infections,
• in the course of parasitic infestations,
• in the course of the menstruation cycle,
b) telehealth monitoring.
2.3 Counterindications
Do not use the device, if wounds or abrasions are present at the applica-
tion site.
2.4 Possible undesirable effects and product safety
Pay attention to the effects of the prolonged contact between the sensor
and the skin, especially if you are allergic to nickel and chromium – the
metals included in the sensor probe material. In the case of an allergic
reaction, stop using the device and seek medical attention.
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Leaving the device on your body for a period longer than 30 days may lead
to the development of pressure sores. Control the condition of your body
at the site where the product comes into contact with the skin and change
the application site maximum every 7 days.
2.5 Precautions and warnings
The product must be used in accordance with this manual. Read the
manual before you start using the product.
Using the device does not replace an appointment with the doctor.
The device contains small parts which may be swallowed or cause
choking. The swallowing of the battery may result in dangerous internal
injuries, developing within a few hours.
If you swallow the sensor or its parts, you must contact seek medical at-
tention immediately. In the case of choking, provide rst aid immediately.
Because of the risk of swallowing, the device is intended for children
above the age of 3, however, special attention and constant supervision
are also recommended for older children.
If the device is used in children or persons with reduced cognitive abilities
or consciousness, maintain particular caution and ensure constant
supervision of an adult person.
Make sure that the band is not attached to the limb too tightly as this may
lead to a reduction in the blood supply to the distal part of the limb.
Before using the device in patients with a pacemaker, consult your doctor.
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ENG
The device functions properly only with the WARMIE24 app installed on
the mobile provided with a compliant operating system. List of systems –
see section 4.1. Combination with other applications – see section 4.2.
The radio transmitter emits electromagnetic waves. Before using the
device in patients with a pacemaker, consult your doctor.
Do not use either near devices which produce strong electromagnetic
interferences or near devices which are particularly sensitive to such
interferences. Other radio devices (including their antennas) should not be
placed closer than 30 cm to the WARMIE sensor.
The battery may only be replaced with a battery of the type indicated by
the manufacturer. The use of different battery type may lead to a short-cut
or improper operation of the device. See table 6.1 for a list of approved
batteries.
Use the device at an ambient temperature ranging between 0°C and 50°C.
Do not expose the device to temperatures above 60°C or below -25°C.
Do not use the device when relative humidity is higher than 95% RH.
Do not expose the device to any chemicals which have not been listed in
this manual, to direct sunlight and high temperatures.
Do not modify or open the thermometer for purposes other than battery
replacement.
Do not immerse the device in water or other liquids. The casing of the
device is water-proof only to a limited extent.
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Protect the device against shocks and falls.
Store the product in a clean and dry place.
Store the product in its original, closed packaging, out of reach and sight
of children.
If you notice any irregularities in the operation of the thermometer or that
it is damaged, stop using the device and contact the authorised service
centre indicated by the manufacturer - see section 9.
Do not repair and/or modify the product on your own. Any repairs must
be performed by the service centre indicated by the manufacturer – see
section 9.
If leaking electrolyte comes into contact with mucosa (e.g. eye mucosa),
wash it with plenty of water for at least 15 minutes. If the electrolyte
comes into contact with skin, wash it with water and soap and wipe dry.
2.6 Additional information
The medical device is designed for repeated use.
The device is designed both for domestic and professional use.
The device is not sterile and must not be sterilised. The casing of the
device may only be disinfected with agents indicated by the manufacturer
– see section 6.
The device does not contain any parts which the user may replace on their
own, except the battery.
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ENG
Keep this manual for future reference, if necessary.
In the case of any doubts related to the use of the product, contact the
manufacturer (see section 9).
The device cannot recharge the battery.
2.7 Product classication
Classication Class
Class according to MDD 93/42/EEC Class IIb, rule 10
Power supply Internal battery supply, replaceable battery
Type of used application parts BF type
Ingress protection rating for solids
and water IP54
Sterility Non-sterile product
not intended for sterilisation
Operating mode continuous
2.8 Marking
The meaning of symbols marked on the device as well as used on the
packaging and in the accompanying documentation has been presented below.
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Manufacturer
Before using the device, read the user manual thoroughly.
Batch number
The CE mark which conrms the compliance of the product with
the principal requirements of EU Directives regarding the product,
including the number of the Notied Body which participated in the
compliance assessment process.
CAUTION! IMPORTANT!
Warnings against risks described in the accompanying text.
Disposal of waste electrical and electronic equipment – the
product must be disposed of in accordance with the national regu-
lations concerning the waste electrical and electronic equipment.
BF application parts
Ingress protection rating for water and solids
Storage temperature range
Usage temperature range
Non-sterile
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ENG
2.9 Product label
2.10 Environmental working, storage and transport conditions
2.10.1 Working conditions
Ambient temperature from 0°C to 50°C
Relative humidity from 5% to 90% RH
Atmospheric pressure
(corresponds to the height above
sea level)
700 hPa ~ 1060 hPa
(up to 2000 m above sea level)
Required time of acclimatisation of
the device after its application on
skin and before commencing the
interpretation of the read results
until the device reaches the body tempera-
ture (at least 15 minutes).
Electromagnetic eld strength
(within the frequency range)
up to 10V/m, in the range between
80MHzand2.7GHz
up to 3V/m, in the range between 2.7and
6GHz
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2.10.2 Storage and transport conditions
Ambient temperature from -25˚C to 60˚C
Relative humidity from 5% to 90 %
(without condensation)
Atmospheric pressure
(corresponds to the height above
sea level)
700 hPa ~ 1060 hPa
(up to 3000 m above sea level)
3 DESIGN AND OPERATION
3.1 Equipment
The WARMIE system consists of:
• the device per se - the WARMIE temperature sensor, Fig. 5a
• the band (size: S/M and L) - a silicone cover is provided on a single band, Fig. 5b
• the user manual
• the warranty card
Fig. 5 WARMIE sensor with the marked temperature transmitter probe
Fig. 5a Fig. 5b
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ENG
4 INSTALLATION AND OPERATION OF THE PRODUCT
The elements necessary for the operation of the WARMIE medical device
are as follows:
• the WARMIE sensor with a clamping band,
• the mobile (smartphone) and the Android or iOS operating system,
• the free WARMIE24 app installed and activated on the smartphone.
The WARMIE sensor with the armband measures the temperature and
registers the results for a short time. Then, these results are transmitted through
Bluetooth to the WARMIE24 app installed on the user’s smartphone, with which it is
paired.
The WARMIE24 app may be started on any type of a smartphone provi-
ded by any manufacturer, if the smartphone works under the control of the operating
system mentioned in table 4.1 below.
4.1 Supported operating systems of smartphones
Table 4.1: Supported operating systems of smartphones
Operating system The lowest compliant
version
The highest compliant
version
Android 5 10
iOS 13 13
WARMIE Sp. z o.o. shall not guarantee the proper operation of the WAR-
MIE24 app. on devices with an incompatible version of the operating system. The
application will not operate properly, if the version of the operating system is lower
than the one given in the second column of the table.
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The third column contains the highest number of the system’s version
with which the manufacturer has tested the device. The application should also work
properly with higher versions of the system, but the manufacturer cannot guaran-
tee this. The manufacturer will conduct tests for each newly appearing version of
the system and will publish information about its compliance on the manufacturer’s
website www.warmie.eu. If any non-compliance is identied, the manufacturer will try
to introduce the necessary improvements and make its newer version available.
If the version of the system on your smartphone is higher than the one
listed in the column entitled The highest tested version, check the up-to-
-date information at www.warmie.eu or contact the manufacturer.
4.2 WARMIE24 application
1. Before using the thermometer, download the WARMIE24 app from:
• the Google Play store, and then install it on your mobile with the Androdid 5.0
system or any other higher version, or
• the AppStore, and then install it on your mobile with the iOS 13 system or any
other higher version
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ENG
The use of the WARMIE sensor with the applications whose manufac-
turers have not obtained a written conrmation from WARMIESp.zo.o.
regarding their compliance means that the medical device is used in a
manner that does not comply with its intended use. The manufacturer
shall not be held liable for the consequences of such use.
2. Before starting the application, activate the WARMIE sensor and put it into the
pairing state - this is described in section 4.3 below.
3. During the rst start-up, the WARMIE24 app performs the Bluetooth scan in
search of Bluetooth Low Energy devices which communicate the data that
identify the device as the WARMIE sensor - especially the string of WARMIE
characters.
4. The scan is carried out until the device which was put into the pairing state or
the previously connected device saved in the application’s memory is detected.
5. After the successful pairing, the application automatically shows the current
temperature on the main screen, transmitted by the sensor with which it is
connected. If the pairing is unsuccessful, the screen will keep showing the
information about the missing connection until it is established.
The established connection is maintained until it is broken as a result of
losing radio coverage, or switching off the device. If the connection is bro-
ken by a system event, the application automatically seeks to resume it.
The device, which is not used to perform measurements for a period lon-
ger than 7 days, is automatically deactivated and its repeated activation in
a manner described in 4.3 is required.
The application will signal such a necessity by a message on the screen
just as is the case with the rst use of the device.
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4.3 Activation, deactivation of the connection – pairing of devices
The proper operation of the device requires the establishment of a per-
manent Bluetooth radio connection between the WARMIE sensor and the smartpho-
ne, on which the WARMIE24 app is installed, i.e. the pairing of the WARMIE sensor
with the smartphone. The user performs the pairing of these two devices in a simple
manner described below. If the sensor is used continuously, or with short breaks, the
pairing procedure is only conducted before the rst use, then the devices establish the
connection automatically each time it is broken.
The repeated pairing of the devices by the user is necessary only after
the manual deactivation of the connection or a very long period when the communi-
cation between the devices is not available (lack of coverage).
4.3.1 Activation of the connection – pairing of devices
Before the connection between the sensor and the smartphone is ac-
tivated, start the WARMIE24 application on your smartphone. The application must
not be paired with any sensor. Whether the application is paired, can be checked in
the “Settings” menu: the number of the sensor with which the application is paired is
displayed on the DATA bar in the menu. In such a case, the current connection must
be broken in a manner described in section 4.3.2.
In order to activate the connection, press the centre of the casing with
your nger. The easiest way in which this can be done is to grab the casing between
your thumb and index nger and press the casing with your ngers.
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ENG
The activation of the device will be conrmed by a short ash of the LED
installed inside the casing. Note! The ash will be invisible in strong light.
4.3.2 Deactivation of the connection
The connection of the smartphone with the sensor may be interrupted
manually from the level of the WARMIE24 app, e.g. in order to establish a connection
with another sensor or to stop the measurements for a longer period of time. The
connection is interrupted (deactivated) from the following menu: Settings >> Clear
PROBE
DIODE LIGHT SQUEEZE THE DEVICE IN THE CEN-
TRAL PART
Fig. 1: Activation of
the device to start
the pairing process
and measurements
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