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

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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 classication........................................................................................ 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 notications ...................................... 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 specied 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 GooglePlay
store / AppStore and installed on the user’s mobile phone.
The mobile phone must meet specic 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 specic WARMIE Sensor and a
specic 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.