Related Manuals for cosinuss c-med alpha
Summary of Contents for cosinuss c-med alpha
- Page 1 User manual c-med° alpha* Version: V08 DOC ID: 1604046957 FCC ID: 2ATBZMS01MC01 IC-ID: 25048-MS01MC01 Typ: In-ear sensor: MS01 Charging box: MC01 Languages available Deutsch English...
-
Page 2: Table Of Contents
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... - Page 3 Quality index Perfusion index Shutdown Close the App Turn in-ear sensor off and storage Charging Health data Cosinuss GmbH Data privacy and data security Troubleshooting Switching on and off, charging Connection and transmission Vital signs display Wearing comfort Care and cleaning...
- Page 4 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...
-
Page 5: Important
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. ●... -
Page 6: Usage / Application
Do not try to open the housing or repair electronic components. Opening the housing may damage the in-ear sensor whereby the liability for material defects becomes void. Repairs may only be carried out by trained cosinuss° personnel. ● Don’t make any modifications to the in-ear sensor or any other parts of the scope of delivery, as these will affect the performance of the c-med°... -
Page 7: Bluetooth
● As with all medical devices, lay cables and connections carefully, so that you or the monitored person cannot become entangled in it and possibly be strangled or injured. ● Use only power supplies approved by cosinuss° for in-ear sensor and c-med° alpha charging box. -
Page 8: Influencing Factors
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. -
Page 9: Normal Body Temperature
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. 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. -
Page 10: Manufacturer Information
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... -
Page 11: Signs And Symbols
EC Directive on Electrical Waste. cosinuss° makes an annual contribution to the environmentally friendly disposal of its products. CE 0123: The CE marking and the number of the notified body must attest... -
Page 12: Scope Of Delivery
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). -
Page 13: Product Description
● 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. -
Page 14: Contraindication
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). ●... -
Page 15: Technical Principle
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. -
Page 16: Accuracy Of Spo2
Accuracy of SpO The SpO 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). -
Page 17: Application Environment
● 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. -
Page 18: In-Ear Sensor
Place of measurement in the external auditory canal. Auricle rim Entrance to the auditory canal Antitragus Earlobe Hypothalamus Middle ear Auricle Outer auditory canal Blood vessels Eardrum In-ear sensor... -
Page 19: In-Ear Sensor & Led States
The c-med° alpha in-ear sensor for vital signs monitoring. Sensor neck Red/Infrared LED Contact thermometer Infrared thermometer Photodiode Antitragus curve Pickaxe Status LED Circuit board and battery Charging LED Charging contacts In-ear sensor & LED states The LEDs of the c-med° alpha has the following possible states: Status LED LED behaviour Description... -
Page 20: Charging Led
Blinking green Connected. (a short blink every 2.5 seconds) The in-ear sensor is working properly. Blinking red Connected. (a short blink every 2.5 seconds) The in-ear sensor is working properly, but the battery is low. Solid red Connected. (only applicable if sensor is But the in-ear sensor is probably damaged, placed in the ear) due to improperly working sensors and circuits. - Page 21 Vital signs monitoring screen of the c-med° App. Serial number and in-ear sensor type In-ear sensor battery status Bluetooth connection status Current body temperature value (°C) Current heart rate value (bpm) Quality index Current SpO value (%) Perfusion index Sensor Firmware Version App Version...
-
Page 22: Accessories
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. -
Page 23: The Power Supply And Charging Cable
The c-med° alpha charging box. Recess Charging contacts Micro USB socket The power supply and charging cable The power supply and the charging cable. USB socket Power supply Euro plug USB plug Micro USB plug Charging cable Operation Preconditions These preconditions are best practice to ensure before operation. -
Page 24: Initial 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. ●... -
Page 25: Identify The In-Ear Sensor
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 ●... -
Page 26: Apply The In-Ear Sensor To The Ear
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. ●... -
Page 27: Monitoring
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. -
Page 28: Vital Sign Cards Specification
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. -
Page 29: Check Signal Quality
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. -
Page 30: Quality Index
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 SpO values. -
Page 31: Turn In-Ear Sensor Off And Storage
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. -
Page 32: Health Data
Please use only trustworthy and secure devices and services. Cosinuss GmbH has no access to your data via the c-med° App and will not transfer any data to third parties without your prior consent. -
Page 34: Troubleshooting
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°... -
Page 35: Vital Signs Display
Vital signs display Problem Indicator Reason Solution No vital signs are The value shows no No in-ear sensor Connect your value (--.-) connected. sensor. displayed. No in-ear sensor in See chapter: Bluetooth range. Warnings and precautions > Bluetooth No new values Check Bluetooth incoming since 30 connection. -
Page 36: Care And Cleaning
Before and after each use clean the in-ear sensor as shown in the following instructions. For disinfection and cleaning Cosinuss GmbH recommends the use of ‘Schülke mikrozid® AF liquid’ as an alcohol-based cleaning agent. Alternatively, any other disinfectant with the following composition can be used: 35% (w/w) 1-propanol, 25% (w/w) ethanol, no fragrances, undiluted application. - Page 37 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.
-
Page 38: Charging Box
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. -
Page 39: Product Specifications
Product specifications General MS01 Generation 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 (SpO ), core body temperature. Status indicators RGB-LEDs Vital signs display Smartphone application (App): Current temperature (°C),... -
Page 40: Radio Data Transmission
Type of applied part 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°... -
Page 41: Sensor Technology
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, SpO Photoplethysmography (PPG) sensor Type Red LED, infrared LED and photodiode Method... -
Page 42: Vital Signs
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 0.1 Hz Heart rate Type Measuring range 35 bpm –... -
Page 43: Power Supply
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 Socket Micro-USB B Power supply Model FJ-SW2050501000E (Type C), FJ-SW2050501000U (Type A) -
Page 44: Smartphone Application (App)
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. -
Page 45: Fcc According Information And Statements
If you are experiencing any unexpected operation or event, or if you need help or assistance in applying the c-med° alpha monitoring system, please contact our customer service with a detailed description of your concern: Cosinuss GmbH Kistlerhofstraße 60 D-81379 Munich, Germany... -
Page 46: Unique Device Identification
It contains the following information of the c-med° alpha. Serial number The serial number consists of the last 6 digits of the UID. cosinuss° uses this number to verify the c-med° alpha monitoring system during its usage. Where to find Labeling information? -
Page 47: Where To Find The Udi And Serial Number
● IP class ● CE marking ● LOT, TYP/Model ● Charging information ● Safety information ● UDI ● Manufacturer information ● Date of manufacturing SALES LABEL: ● Production QR-code ● Medical class ● Size ● TYP/Model ● CE marking ● GTIN barcode ●... -
Page 48: Statement
Cosinuss GmbH is not liable for any misuse or unauthorized use of the product. Cosinuss GmbH is not liable for the loss or misuse of personal data or the product. There are no replaceable parts in the in-ear sensor. Components supplied must not be exchanged.
Need help?
Do you have a question about the c-med alpha and is the answer not in the manual?
Questions and answers