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USER MANUAL

WARMIE

WM-1020

Temperature monitoring system

Poznan, 2020-11-16

ENG

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Summary of Contents for WM-1020

Page 1: ...USER MANUAL WARMIE WM 1020 Temperature monitoring system Poznan 2020 11 16 ENG ...

Page 2: ...2 ENG READ CAREFULLY THE ENTIRE USER MANUAL BECAUSE IT CONTAINS INFORMATION THAT IS IMPORTANT FOR THE USER ...

Page 3: ...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 de...

Page 4: ...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 I...

Page 5: ... 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 temper...

Page 6: ...t 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 Sens...

Page 7: ...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 c...

Page 8: ...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 ...

Page 9: ...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 first 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 ...

Page 10: ...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 t...

Page 11: ...e 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 professi...

Page 12: ...ass 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 accompanyi...

Page 13: ...ody 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 ...

Page 14: ...eight 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 field strength within the frequency range up to 10V m in the range between 80MHz and 2 7GHz up to 3V m in the r...

Page 15: ...ght 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 ...

Page 16: ...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 Andr...

Page 17: ...mpliance is identified 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...

Page 18: ...ce 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...

Page 19: ...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...

Page 20: ...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 proc...

Page 21: ...ns the connection for approx 7 days and if not the sensor breaks the connection after about one hour 4 4 Placement of the sensor on the patient s body The only correct place for placing the sensor to monitor the body tem perature is inside the armpit see Fig 2 The sensor has been optimised for the measurement of temperatu re inside the armpit Although it is possible to measure the temperature at a...

Page 22: ...nce of maximum 3 cm 3 After placing the sensor in your armpit it is recommended that you wait for minimum 15 minutes until the sensor begins to provide the correct temperature measurement results At this time the sensor temperature rises quickly and the results provided by the device may differ from the real ones 4 In order to obtain the correct measurements it is important that the once atta ched...

Page 23: ...rt the procedure of establishing a connec tion with the WARMIE sensor 4 In the case of the first connection of the device or after a longer period of inactivity the screen will display a message about the need to activate the device see section 4 3 5 After the connection is established the application begins to display the current results of the temperature measurement this is described in section...

Page 24: ...sensor is broken the me asurement results are not lost for a certain period of time as the sensor has its own register in which the results can be collected for several hours The results will be read after reconnecting the application with the sensor 5 It is possible to start interpreting the provided results after the readings are stabilised i e after approx 15 20 minutes The previously read resu...

Page 25: ... connection notifications Download the measurements in the background Measurement settings Fig 3 Main screen of the WARMIE24 app after it is connected with the sensor and the setting screen upper and lower part not visible entirely on the screen 1 2a 2b ...

Page 26: ...change the measurement unit using the available options degrees Celsius and degrees Fahrenheit The user can also change the type of measurement between the measurement of surface temperature and body temperature In the second case the result is compensated so as to make it as close to the body temperature as possible 4 8 Measurement registration The current result of the temperature measurement is...

Page 27: ... the current value of the temperature threshold and which is below the current measurement on the main screen The temperature threshold levels may be adjusted in the following ran ges 31 0 36 5 C low temperature and 36 6 41 0 C high temperature 4 11 Export of measurement results The WARMIE24 app registers all measurements received from the WAR MIE sensor with which it is paired on a current basis ...

Page 28: ... the only result is switching to the off line mode and a change in the interval from 1 second to 1 minute Note In the off line mode the sensor can register maximum 1000 samples over 16 hours of registration After resuming the connection which takes place automatically in the majority of cases the application reads the buffer content from the sensor and adds it to its own register This way the cont...

Page 29: ... now on it is possible to establish a connection with the same or other sensor through the activation procedure described on section 4 3 5 NOTIFICATIONS Notifica tion name Notification trigger Form Possibility to use the di sable option by the user High tem perature Upper temperature threshold exceeded by default 38 C Presentation of a measurement in red on the main screen sound push notifi cation...

Page 30: ...e product at home basic rules of maintaining the hygiene of the device must be observed If used during an infection the product must be disinfected after each use using disinfectant wipes for medical devices soaked in ethyl alcohol or isopropyl alcohol During the disinfection instructions for use on the disinfectant product s label must be strictly observed When using the product in a hospital env...

Page 31: ...he casing For this purpose you can turn this part of the casing with the battery upside down and tap the casing against the table top the battery will fall onto the table top 6 Prepare the new battery and insert it in accordance with the marking on the casing and 7 Close the device by pressing together the two parts of the casing in the central part you will hear a click 8 After replacing the batt...

Page 32: ...TING 7 1 Failures damage contact with the service centre If you notice any irregularities in the operation of the medical device make sure that you act in accordance with this manual see the following subsections of this section to seek a solution for the most frequently occurring problems if you do not find the right solution contact the service centre You can send the e mail message to the servi...

Page 33: ...or enabling Bluetooth on your mobile WARMIE does not require having the Bluetooth communication launched on the phone to download the sensor s measurement results Enable Bluetooth and location services in the phone settings during the first connec tion with the device 7 2 3 Information about the lack of connection The app may display a message that the WARMIE sensor is not connec ted This happens ...

Page 34: ...uetooth 4 0 correct transmission range of up to 10 metres in free space The actual range depends on am bient conditions and a mobile phone s specifications Equipment WARMIE temperature sensor two bands sizes S M and L silicone cover casing opener user manual and warranty card Power supply CR2032 lithium battery min capacity 220mAh nomi nal voltage 3V the battery in the device is replaceable Batter...

Page 35: ...ska 62 60 316 Poznań Polska tel 48 501 647 303 The marking of this device with the symbol of the crossed out waste bin indicates that the equipment and batteries it contains must not be placed with other household waste after their useful life The user is obliged to hand them over to waste electrical and electronic equipment collection points Waste collection points including local collection poin...

Page 36: ...The project is co financed by the European Union ...

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