ENGLISH Instruction Manual Version: V1.
Deutsch English Manufacturer information This product is manufactured by Cosinuss GmbH. Please read the instructions for use carefully before using the device for the first time. This makes it easier for you to use the product correctly. Please keep these instructions for use in a safe place. In case of a high and long-lasting fever always consult your doctor. COSINUSS GMBH Kistlerhofstraße 60, D-81379 Munich, Germany 1234 Telefon: +49 (0)89 740 418 32 Email: info@cosinuss.com Internet: www.cosinuss.
Follow the instructions for use. The following symbols are used in this operating instructions and on the device. Product with application parts of type BF. Warning, Attention, Note. Warning and safety information on health hazards or possible damage to the device or accessories. This product contains batteries and recyclable electrical waste.
4 Warnings • Connection and transmission and precautions • Wearing comfort • Temperature display • The body temperature 63 • External influence factors 03 Manufacturer • The infrared thermometer information • The charging box Health data • The power supply and • Cosinuss GmbH Signs and Symbols Table of contents • Prepare the measurement Scope of delivery • Purpose of use 6 the wearable thermometer meter on to the ear.
Product description Check the scope of delivery for external intactness of the carton packaging and completeness of the contents. Application principle Before use, make sure that the device and accessories are free of visible damage and that all packaging material is removed. The continuous temperature measurement with the degree° is carried out with the help of two elements. In case of doubt, do not use the device and contact your salesperson or our customer service.
Purpose of use The wearable infrared ear thermometer degree° is suitable for non-invasive and continuous measurement and monitoring of human body temperature in children from 6 months, adolescents and adults.The degree° infrared thermometer is worn continuously on the ear and positioned in the outer auditory canal. It is a reusable and wearable ear thermometer intended for domestic use.
• • • • • • Measurement of body temperature in the ear canal Non-invasive and continuous measurement Reliable and stable temperature output Good readability of body temperature Biocompatibility Very low and hazard-free radiation exposure due to radio waves therefore affect the ear more quickly than other parts of the body. 1 5 7 2 3 6 4 8 9 Why inside the ear? The ear is the ideal place to measure the core body temperature. The core temperature is the temperature of the vital organs.
The infrared in-ear thermometer 1 The degree° thermometer measures and stores the temperature information and sends it via Bluetooth Low Energy to a connected receiver. Continuous temperature monitoring in the ear via infrared is a highly reliable, non-invasive monitoring method. 2 3 5 9 8 The degree° thermometer Constituents 2. 3. 4. 5. 6. 7. Product description 7 4 1.
Turn it on Take the degree° thermometer out of the charging box LED = Blue Visible for Bluetooth connections Monitoring Position the degree° thermometer in the ear and wait LED = White Low temperature 34,0° – 35,0° C LED = Green Normal temperature 35,1° – 37,5° C LED = Yellow Increased temperature 37,6° – 38,5° C LED = Red High temperature 38,6° – 43,0° C Turn it off Return the degree° thermometer back into the charging box Displayed temperature range 34,0° bis 43,0° C Radi
Download the app Navigation structure of the App The degree° App is not physically included with the degree°. It needs to be downloaded to your smartphone for Android via the Google Play Store and for iOS via the Apple App Store. You can do this free of charge and at any time. ENGLISH Before installing the degree° App, check whether it is compatible with the version of the operating system (Android or iOS) used on your smartphone.
Navigation in the App Tap on the Navigation icon , at the top left of any main screen to open the navigation of the app. Tap on a navigation point to open and edit the selected screen. 1 to go back one navigation level. to close a page.
Temperature screen Constituents of the temperature screen Navigation 1 Back to main navigation 2 Current navigation point 3 4 5 6 7 8 9 10 11 22 Product description 12 13 Temperature Curve 3 Tabs with different time units 4 Date display 5 y-axis with temperature scale 6 Temperature curve 7 Colored temperature range 8 Current point of measurement 9 x-axis with time units ENGLISH 1 2 Classic temperature display 10 Current temperature in numbers Device information of connected Thermometer 11 Blueto
ENGLISH Connect the thermometer in the app2,3 App screen - Navigation App screen - Settings App screen - Bluetooth App screen - Bluetooth Settings Bluetooth Select thermometer Successful connection Select settings in the main navigation. Select Bluetooth in the settings screen. Select your degree° thermometer from the list of available devices. With a successful Bluetooth connection, the degree° thermometer becomes the connected device. 2 The degree° must be switched on.
About degree° Support On the About degree° screen you will find: Tap Support to visit the external link to the online help section: support.cosinuss.
The charging box The degree° charging box is used for charging the degree° thermometer as well as for safe storage and transport. 4 As soon as you remove the sensor from the box, it switches on automatically. Put the sensor back into the box after use and it will switch off automatically. ENGLISH 1 2 3 To charge the degree° thermometer, put it into the charging box, connect the charging box to a power supply using the supplied accessories, USB charging cable and mains adapter.
The degree° power supply and the USB charging cable that are in the scope of delivery must be used for the safe power supply of the charging box and thus for charging the thermometer. 1 4 5 2 6 3 The degree° power supply and charging cable Constituents Warning: The use of power supplies and charging cables other than the ones in the scope of delivery is not permitted and unsafe, as they cannot guarantee electromagnetic compatibility.
Prepare the measurement Technical parts Ensure the following technical basics before starting the measurement: • The latest version of the degree° App is installed on your mobile phone. • The degree° and your smartphone are appropriately charged. • Disturbing influencing factors for the Bluetooth connection are minimized. • Factors influencing the accuracy of the monitoring process are minimized. Hygiene • • • Use a clean sensor with a cleaned sensor head.
Start the app and connect the wearable thermometer. Select the degree° thermometer from the list of available devices in the app on the Settings > Bluetooth page. ENGLISH Activate the Bluetooth service on your smartphone. The degree° thermometer now connects to the degree° app. Start the degree° app on your smartphone. Follow the instructions on the screen and finally select the profile of the person whose temperature you want to measure. Select Temperature in the main navigation.
Guide the rear part of the thermometer behind the auricle. The neck sensor lies over the edge of the auricle and leads to the external auditory canal. Hang the thermometer gently over your ear. Eventually you want to pre-bend the sensor neck to direct the sensor head into the ear canal. Carefully insert the sensor head into the outer ear canal. The lens of the sensor head now points towards the eardrum. 36 Application The sensor head may just disappear into the auditory canal.
The display of the first temperature values may take a short moment. Any change in temperature is then detected in real time. Once the degree° thermometer has detected a valid temperature of over 34.0° C in the ear canal, the color of the LED on the device itself changes and the information is sent to the app.
First, make sure that the sensor is connected to the app so that currently missing data points can be transmitted to the app. Put the sensor back into the charging box. It then switches itself off automatically. ENGLISH End the measurement You can now close the app completely. Remove the sensor from the ear. The temperature values will drop quickly below 34° C. The LED on the device will turn white and the app will not display any temperature anymore.
Warnings and precautions temperature range of every one. This will help you to determine not normal values later on. Normal body temperature External factors can influence the temperature measured in the ear: The “normal” body temperature is not a fixed number but a temperature range. It varies depending on the location of the measurement, age and external factors. It also varies from person to person and varies throughout the day. Therefore, it is important to determine individual temperature ranges.
• degree° is intended for use in a domestic environment only. This product is not suitable for diagnosing disease or assessing hypothermia, but it is a useful tool for monitoring the temperature. • Please contact your doctor if the monitored temperature is elevated for more than two days already. • The use of this device cannot replace your attention for your child or consultation with your doctor.
• Infants and young children under 3 months • Patients over 60 years of age • Patients with diabetes mellitus or a weakened immune Health Data Cosinuss GmbH Cosinuss Gmbh is a certified medical device manufacturer and meets all requirements for quality management and the harmonized standard ISO 13485. system (e.g. HIV positive, cancer chemotherapy, chronic steroid treatment, splenectomy) • Bedridden patients (e.g. secret patients, stroke, chronic illness, after surgery) • Transplanted patients (e.
We take the protection of your personal data very seriously. We treat your personal data confidentially and according to the legal data protection regulations as well as our data protection declaration. This privacy statement applies to our mobile iPhone and Android apps. It explains the type, purpose and scope of data collection in the context of app usage.
received with the Bluetooth function, for example by abusive interception of the data. There should be no people, buildings, walls or other obstacles between your degree° thermometer and the other connected device as these may affect the connection quality. Data handling Please use only trustworthy and properly secured devices. If there are obstacles between the devices, the 10 m range may be reduced. The use of the Bluetooth function for unlawful purposes is prohibited: piracy, eavesdropping, etc.
Data will be stored in the internal flash memory of the degree° device: • • • in case of longer interruptions of the Bluetooth connection in case the buffer is filled up completely, in the event of a critical battery charging status If there is a new Bluetooth connection, the data will be sent again and transmitted to your smartphone. Deletion of data Switch off the degree° Put the device back into the charging box to switch it off.
If a problem occurs with your degree°, please follow these troubleshooting information first. If this does not solve the problem, please contact Cosinuss GmbH customer service. Switching on and off, charging The degree° thermometer does not switch on. If the degree° does not switch on after removal from the box, either the battery is empty and needs to be charged or the device is defective. Please charge the device for one hour and try again afterwards.
The app signals connection interrupts. The Bluetooth connection between your degree° and smartphone is not stable. Please see the notes on data transmission via Bluetooth. The degree° is located outside the reception or transmission radius to your smartphone. The data transmission via Bluetooth Low Energy has a radius of max. 10 m. Make sure that degree° and smartphone are within this radius.
Check the correct fit of the sensor, the sensor head and its alignment of the sensor lens. The sensor head must point in direction of the ear drum. The sensor should lie on the auricle.See also > Applying degree° on the ear. Pay particular attention to the external influencing factors in the warning notices. These can influence the measurement results.
Care and cleaning The thermometer hurts in the ear The sensor head and the sensor lens are the most sensitive parts of the device. Thy should be always clean and faultless to ensure accurate monitoring. Check the correct fit of the degree° in the ear. Try to adjust the sensor where it hurts. Take special care that the sensor head does not press too deeply into the ear canal. If the ears are very sensitive to pressure, adjust the sensor more often and pause the monitoring from time to time.
Product specifications degree° thermometer LED = Green Normal temperature LED = Yellow Increased temperature LED = Red High temperature Temperatur anzeige II Smartphone Anwendung (App) colored temperature curve Modell DS02 Type Infrared temperature monitor, direct reading Use Can be worn on the ear Place of monitoring Ear, external auditory canal, eardrum Parameter Core body temperature Temperature display I LED = White 62 ENGLISH Current Temperature in numbers, General Colored LED o
Minimum 2 years Memory Buffer Flash Memory 18 kB RAM 512 kB Firmware The version of the installed firmware can be viewed any time in the app under the following menu item: degree° > About this degree°. Updates reserved. Temperature sensor Typ Infrared sensing element Displeayed temperature range 34° C – 43° C (93.2°F – 109.
Typ Bluetooth Version Low Energy, Spezifikation Version 4.2 Frequency ISM band 2.4 - 2.
PC+ABS V0 UL-94 Bayblend FR3010 Protection type IP21 Objects bigger than 12,5 mm, waterdrops Protection class II Power supply Model FJ - SW 266 050 1000 E Application Power supply, voltage transformer Input 100 - 240 V ~ 50 / 60 Hz, 0,35 A Max.
EN ISO 80601-2-56 Particular requirements for the safety, including essential performance, of medical thermometers for measuring body temperature. EN 60601-1: 2006 Medical electrical equipment - Part 1: General requirements for safety, including essential performance. EN ISO 14971:2012 Medical devices - Application of risk management to medical devices. EN ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Assessment and verification under a risk management system.
AND STATEMENTS User Information according to FCC 15.21: Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Statement according to. FCC 15.19 This device contains license-exempt transmitter(s)/ receiver(s) that complies with FCC Part 15 and Innovation, Science and Economic Development Canada’s license-exempt RSS.
Please always quote the unique identity number of your degree° when making enquiries. You will find this 28-digit number on the back of the packaging, on the bottom of the charging box and in the app. It contains the manufacturer information, article-, model-, batch-, and identity number of the degree°.
Statement Disclaimer Cosinuss GmbH can only offer these services for products sold directly by cosinuss° or by salespersons authorized by cosinuss°. If you have purchased from another seller, please contact them for any claims. For questions about health and for medical advice, please always consult your doctor. ENGLISH Cosinuss GmbH does not make any medical recommendations. Bluetooth® is a registered trademark of Bluetooth SIG Inc.
ENGLISH Notes 78 Inhaltsverzeichnis Inhaltsverzeichnis 79
80
