User manual c-med° alpha* Version: V08 DOC ID: 1604046957 FCC ID: IC-ID: 2ATBZMS01MC01 25048-MS01MC01 Typ: In-ear sensor: MS01 Charging box: MC01 Languages available Deutsch English
User manual c-med° alpha* Languages available Important Warnings and precautions Health status Usage / application Bluetooth Influencing factors External influencing factors Internal influencing factors Normal body temperature Normal heart rate Normal oxygen saturation (SpO2) Manufacturer information Signs and symbols Scope of delivery Product description Intended use Intended operator Essential performance Use and indication Contraindication Application principle Technical principle Infrared temperature se
Charging and safe keeping The charging box The power supply and charging cable Operation Preconditions Initial operation Turn in-ear sensor on Open the App Identify the in-ear sensor Connect the in-ear sensor Clean the in-ear sensor Apply the in-ear sensor to the ear Leave the in-ear sensor gently hanging on top of your ear.
Rechargeable battery Sensor technology Photoplethysmography (PPG) sensor Thermometer Accelerometer Vital signs Body temperature Heart rate Oxygen saturation (SpO2) Accessories Charging box Power supply Charger cable Smartphone application (App) Standards and directives FCC according information and statements Customer service Unique Device Identification Serial number Where to find the UDI and serial number? Liability for material defects Statement Disclaimer 38 39 39 39 39 40 40 40 40 41 41 41 42 42 42 43
Important ● Please read the instructions for use carefully before using the c-med° alpha monitoring system 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. ● Warning: A warning is issued if certain health hazards (i.e. injury, serious undesirable side effects) or possible damage to the in-ear sensor or accessories are possible. ● Note: A note is displayed if additional general information is available.
● Under certain circumstances, it is possible that the in-ear sensor may erroneously consider a movement as good pulse quality interpreted. Therefore keep movement during the measurement to a minimum. Usage / application ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Only use the c-med° alpha in the ear. The measurement at rest provides the best results.
● ● ● ● ● ● ● ● ● ● ● ● ● ● Do not use the in-ear sensor under water (bath, shower, swimming). To avoid inaccurate monitoring, always clean the c-med° alpha after usage according to the cleaning instructions in this document (See chapter: Care and cleaning). Pay attention to disturbed fitting due to jewelry, glasses or other objects. Make sure that your or the monitored person’s ear canal is free of any disturbing objects.
● this reason, these devices may experience interference when a Bluetooth connection is established near such products. cosinuss° is not responsible for any loss of data sent or received using the Bluetooth function. For example, through improper interception of the data. Influencing factors Multiple factors can influence the vitals signs measurement inside the ear: NOTE: ● Only use the c-med° alpha in the ear. ● The measurement at rest provides the best results.
Normal body temperature The “normal” body temperature is not a fixed number but a temperature range. In a healthy adult the normal temperature ranges from 36.5 °C – 37.4 °C.1 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. The c-med° alpha is suitable as a continuous monitoring in-ear sensor for measuring the body temperature.
Manufacturer information This product is manufactured by Cosinuss GmbH. 0123 COSINUSS GMBH Kistlerhofstraße 60, D-81379 Munich, Germany Telefon: +49 (0)89 740 418 32 Email: info@cosinuss.com Internet: www.cosinuss.com Patents: DE 102 011 081 815 B4, DE102013222131A1, US10478123B2, CA2966232A1, CA2875901C, DK2717756T3, ES2728673T3 Designed in Germany.
Signs and symbols The following symbols are used in the operating instructions and on the in-ear sensor. WARNING: Warning and safety information on health hazards (i.e. injury, serious undesirable side effects, death) or possible damage to the in-ear sensor or accessories. NOTE: A note is displayed if additional general information is available. Not be disposed of with household waste: This product contains batteries and recyclable electrical waste.
c-med° alpha in-ear sensor. c-med° alpha charging box. Universal Serial Bus (USB). Bluetooth Low Energy (BLE): Radio data transmission by means of electromagnetic radiation. FCC: American seal, confirms electromagnetic compatibility. Direct Current (DC) voltage. Plug type C: European power plug type for small consumers. (without earthing contact). Plug type A: North American power plug type for small consumers (without earthing contact).
● ● Charging cable (USB / Micro-USB) User manual Product description Intended use The c-med° alpha is intended to be used as a medical measuring device in applications in a home healthcare environment. The c-med° alpha can continuously measure and visualize core body temperature, heart rate and blood oxygen saturation of healthy or sick persons starting at the age of 18. Intended operator Intended operator can be every adult person without mental restriction.
Contraindication Do not use the in-ear sensor: ● ● ● ● ● ● ● In cases of any ear diseases. Outside or under windy conditions. In cases of CO intoxication. On children younger than 18 years. On any other measure site (only in the ear canal). In a magnetic resonance tomography room. In potentially explosive areas. Application principle The in-ear sensor can only be used in combination with its charging box, a mobile device (smartphone) of the respective user and the installed App.
Technical principle Two different sensor types within the c-med° alpha will be used to get the relevant raw data: An infrared temperature sensor and an optical Photoplethysmography (PPG) sensor, consisting of two LEDs and one photodiode. Infrared temperature sensor A thermal infrared sensor is used to make raw temperature measurements. This sensor passively measures the heat radiation of the eardrum plus the radiated heat of the surrounding auditory canal.
Accuracy of SpO2 The SpO2 shall be measured with an accuracy of rms +/- 4% within the range of 70% – 100%. Functional oxygen saturation Functional oxygen saturation is the percentage of saturation given by the concentration of oxyhemoglobin (cO2Hb) divided by the sum of the concentrations of oxyhemoglobin and deoxyhemoglobin (cHHb). 100 × 𝑐𝑂2𝐻𝑏 𝑐𝑂2𝐻𝑏 + 𝑐𝐻𝐻𝑏 According to the Clinical Laboratory Standards Institute (CLSI), the term for this ratio is hemoglobin-oxygen saturation, and its designation is SO2.
● ● ● ● Temperature: The body temperature can be measured at various places in and outside of the body. The core temperature refers to the temperature of the vital organs. The temperature in the ear correlates with the body core temperature, because the eardrum (the place where c-med° alpha monitors) and the hypothalamus (the temperature control center in the brain) have the same blood supply. Changes in this core temperature therefore affect the ear more quickly than other parts of the body.
Place of measurement in the external auditory canal.
The c-med° alpha in-ear sensor for vital signs monitoring. 1 Sensor neck 2 Red/Infrared LED 3 Contact thermometer 4 Infrared thermometer 5 Photodiode 6 Antitragus curve 7 Pickaxe 8 Status LED 9 Circuit board and battery 10 Charging LED 11 Charging contacts In-ear sensor & LED states The LEDs of the c-med° alpha has the following possible states: Status LED LED behaviour Description Blinking blue (a short blink every 2.5 seconds) Advertising.
Blinking green (a short blink every 2.5 seconds) Connected. The in-ear sensor is working properly. Blinking red (a short blink every 2.5 seconds) Connected. The in-ear sensor is working properly, but the battery is low. Solid red (only applicable if sensor is placed in the ear) Connected. But the in-ear sensor is probably damaged, due to improperly working sensors and circuits. LED is OFF In-ear sensor is turned OFF. In-ear sensor is positioned correctly in the charging box.
Vital signs monitoring screen of the c-med° App.
Accessories Charging and safe keeping A charging box is used for charging and safe keeping of the in-ear sensor. A docking station within the charging box allows the charging of the in-ear sensor’s battery through its charging connections. In that way it is impossible to charge the c-med° alpha while wearing it. The in-ear sensor can only be connected to a power supply through the charging box, which connects to power via an USB cable. For charging put the in-ear sensor into the charging box.
The c-med° alpha charging box. 1 Recess 2 Charging contacts 3 Micro USB socket 4 Lid The power supply and charging cable The power supply and the charging cable. 1 USB socket 2 Power supply 3 Euro plug 4 USB plug 5 Micro USB plug 6 Charging cable Operation Preconditions These preconditions are best practice to ensure before operation.
● ● ● ● ● ● ● Charge the c-med° alpha in-ear sensor to full capacity. Charge your smartphone to full capacity. Install the c-med° App on your smartphone. Establish network connection. Turn ON Bluetooth on your smartphone Read and understand the user manual. Read and understand warnings and precautions. Initial operation Turn in-ear sensor on ● ● ● Take the c-med° alpha out of its charging box. The in-ear sensor will turn ON automatically.
Identify the in-ear sensor ● ● ● Find the serial number of your in-ear sensor on the bottom of the charging box. Enter the serial number in the App. The App automatically verifies your in-ear sensor. Connect the in-ear sensor ● ● The App establishes a Bluetooth connection automatically. The App receives the incoming data from the in-ear sensor. Clean the in-ear sensor ● ● Clean the in-ear sensor before and after each use. Follow the instructions on screen.
Apply the in-ear sensor to the ear ● Guide the rear part of the c-med° alpha behind the auricle. ● Leave the in-ear sensor gently hanging on top of your ear. ● Carefully guide the in-ear sensor head into the entrance of the outer ear canal. ● Adapt the neck of the in-ear sensor to the shape of the ear.
WARNING: Avoid excessive and deep pressure. NOTE: ● The sensor head may just disappear into the auditory canal. ● The sensor head must point towards the eardrum. ● A reinforced shaped wire in the sensor neck helps to maintain the individual positioning. ● Eventually you want to pre-bend the sensor neck for easier application.
Battery level unknown Bluetooth connected Searching for Bluetooth connection Bluetooth disabled NOTE: ● In-ear sensor and smartphone must be within the Bluetooth maximum range of 10 meters. See chapter: Warnings and precautions > Bluetooth. Vital sign cards specification The c-med° App shows the current vital signs values. Each vital sign is displayed in its own card. Concept of vital sign cards. Vital sign cards behaviour The vital signs values will be updated every second.
Value is valid. Value: High emphasis. Quality index: Low emphasis. Value is not valid. Notification: Question mark. Value: Low emphasis. Quality index: High emphasis. No value. NOTE: ● Only use the c-med° alpha in the ear. ● The measurement at rest provides the best results. Avoid unnecessary movements, chewing and talking during the measurement as they can influence the quality of the ppg signal and lead to inaccurate readings of SpO2 and heart rate.
Quality index Quality index for the Photoplethysmography (PPG) signal is an indicator for the reliability of the currently calculated heart rate values. Less than 30 Unreliable heart rate 30 – 100 Reliable heart rate Perfusion index The Perfusion index for the Photoplethysmography (PPG) signal is an indicator for the reliability of the currently calculated SpO2 values. 0 – 0.2 Unreliable SpO2 0.2 – 1.0 Reliable SpO2 more than 1.
Turn in-ear sensor off and storage ● ● ● Put the in-ear sensor back into its charging box. The in-ear sensor turns OFF. Store the in-ear sensor safely within the charging box. Charging 1. Put the in-ear sensor into its charging box. The in-ear sensor turns OFF. 2. Connect the charging cable to the charging box. 3. Connect the power supply to the charging cable. 4. Plug the power supply into a power socket. The in-ear sensor is now charging (LED solid red).
● ● Do not touch the charging contacts or the USB interface simultaneously with the monitored person. The charging box must not be placed in such a way that it is difficult to disconnect it from the mains by unplugging the power supply from the socket. 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.
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Troubleshooting If a problem occurs with your c-med° alpha, please follow these troubleshooting information first. If this does not solve the problem, please contact Cosinuss GmbH customer service. See chapter: Customer service. Switching on and off, charging Problem Indicator Reason Solution The c-med° alpha does not switch ON. Status LED does not Battery is empty. turn ON. Charge in-ear sensor. The c-med° alpha does not turn OFF. Status LED does not The sensor is not turn OFF.
Vital signs display Problem Indicator Reason Solution No vital signs are displayed. The value shows no value (--.-) No in-ear sensor connected. Connect your sensor. No in-ear sensor in Bluetooth range. See chapter: Warnings and precautions > Bluetooth No new values incoming since 30 seconds. Check Bluetooth connection. Measured values are out of range. See chapter: Product specifications Quality index and/or Perfusion index are low. Minimize influencing factors.
See chapter: Warnings and precautions Sensor mechanically broken. Cancel the measurement. See chapter: Warnings and precautions The monitored person’s ear is injured. Cancel the measurement. See chapter: Warnings and precautions Care and cleaning Care Take good care of your c-med° alpha to ensure a long lasting performance. The sensor head and the sensor lens are the most sensitive parts of the c-med° alpha. They should always be clean and faultless to ensure accurate monitoring.
1. Fixate the sensor head between your fingers. 2. Clean the sensor head with a cotton swab soaked in disinfectant. 3. Distribute disinfectant evenly over the entire in-ear sensor. 4. Let the disinfectant work for about 1 minute.
5. Dry the in-ear sensor with a disposable cloth. 6. The in-ear sensor is now ready for use. NOTE: ● Do not use the in-ear sensor until the alcohol has completely evaporated and the in-ear sensor is in a dry state. Charging box 1. Clean the charging box with a simple wipe disinfection. WARNING: Never connect the charging box to any power supply during cleaning. Disconnect the charger before cleaning.
Product specifications General Typ MS01 Generation 1 Device type Continuous vital signs monitor Usage Measuring key vital signs continuously in the outer ear canal. Measuring position Outer ear canal Measured values (parameters) Heart rate, oxygen saturation (SpO2), core body temperature. Status indicators RGB-LEDs Vital signs display Smartphone application (App): Current temperature (°C), heart rate (bpm) and SpO2 (%) in numbers.
Type of applied part BF Service life 2 years (also applies to all supplied parts and accessories) Scope of delivery c-med° alpha in-ear sensor, charging box, charging cable, power supply, manual Firmware The version of the installed firmware can be viewed any time in the c-med° App under About / c-med° App. Updates reserved. Radio data transmission Radio data transmission Type Bluetooth Low Energy (BLE) Version 5.0 (backwards compatible to 4.2) Frequency ISM band 2.4 – 2.
Sensor technology Sensor types Infrared and contact thermometer, optical measurement (LEDs and photodiode), accelerometer Raw data PPG (red, infrared and ambient light), acceleration Quality indices Quality index, Perfusion index Vital signs Heart rate, core body temperature, SpO2 Photoplethysmography (PPG) sensor Type Red LED, infrared LED and photodiode Method Photoplethysmography (PPG) Resolution 24 bit Sampling rate Variable, standard 200 Hz Wavelength range and max.
Vital signs Body temperature Type Infrared thermometer, direct reading Measuring range 34 °C – 43 °C Resolution 0.1 °C Accuracy Inside of the measuring range ± 0.3 °C Outside of the measuring range (--.-) Interval Variable, standard 0.
Usage Storage, transport and charging of the c-med° alpha. Also switches it on and off. Material PC and ABS blend, flame retardant UL 94 V-0 Protection type IP21 Objects bigger than 12,5 mm, waterdrops Protection class II Socket Micro-USB B Power supply Model FJ-SW2050501000E (Type C), FJ-SW2050501000U (Type A) Usage Power supply, voltage transformer Input 100 – 240 V ~ 50/60 Hz, 0.35 A Max.
Usage Connecting charging box and power supply. Socket USB A to Micro-USB B Smartphone application (App) Name c-med° Usage Digital display of the c-med° alpha in-ear sensor. Operating system Android 5 and higher. iOS 9 and higher. Download and installation The software download is free with the purchase of the hardware product. ● ● Version Google Play Store for Android Apple App Store for iOS The version of the installed app can be viewed at any time in the app page About c-med°.
This product complies with the provisions of the EC Directive 93/42/EEC. 2014/53 EV Radio equipment directive. IEC 62304 - Medical device software - Software life cycle processes. FCC / ISED according information 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 complies with Part 15 of the FCC rules.
Phone: +49 (0)89 740 418 32 Email: support@cosinuss.com Internet: www.cosinuss.com Online Support: support.cosinuss.com We will answer your request within 48 hours and do our best to provide you with a viable solution. If you have any health questions, please always consult your doctor. Unique Device Identification The Unique Device Identification (UDI) is a machine-readable tag that serves as a key to a UDI database.
SALES LABEL: ● ● ● ● ● ● ● ● IP class CE marking LOT, TYP/Model Charging information Safety information UDI Manufacturer information Date of manufacturing ● ● ● ● ● ● ● ● ● ● ● ● ● Production QR-code Medical class Size TYP/Model CE marking GTIN barcode UDI FCC ID, IC ID Operating, transport and storage ambiance, Safety information Charging adapter type Manufacturer information Date of manufacturing Where to find the UDI and serial number? Both numbers can be easily found: ● ● ● On the packaging label.
● Compensation (for futile expenses) Statement 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. Bluetooth® is a registered trademark of Bluetooth SIG Inc. Metrological control (infrared thermometer): A metrological control can be required at intervals of 2 years.
