Page 1 User Manual In-ear sensor: MS01 Charging box: MC01 Basic UDI (Sensor): 426046302CMED4F Basic UDI (App): 426046302CMEDAPP4R Version: V18 FCC ID: 2ATBZMS01MC01 Print date: 2023-12-04 IC-ID: 25048-MS01MC01 Doc-ID: 1604046965...
Page 2: Table Of Contents
Table of content Manufacturer information Warnings and precautions Health status � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 10 Usage and application �...
Page 3 Body temperature � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 35 Pulse rate �...
Page 4 Cosinuss GmbH� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �...
Page 5 Standards and regulations FCC / ISED according information and statements � � � � � � � � � � � � � � � � � � � � � � � � 96 Training and Supporting Instruction Customer service Unique Device Identification Sensor UDI �...
Page 6 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: User Manual A warning is issued if certain health hazards (i.e.
Page 7: Manufacturer Information
Manufacturer information This product is manufactured by Cosinuss GmbH. 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.
Page 8: Warnings And Precautions
Warnings and precautions WARNING: Measurement location Do not use the in-ear sensor on other body parts than the ear! WARNING: Prohibited usage Do not use the in-ear sensor: • If it has any visible damages. • In cases of any ear diseases or injuries. •...
Page 9 WARNUNG: Arrhythmia and Circulatory Arrest Since pulse rate measurements are based on an optical detection of a peripheral pulsatile flow, the measurement is limited in specific situations: • Certain arrhythmias may not be detected. Therefore, the pulse oximeter measurement should not be used as a substitute for ECG-based arrhythmia analysis.
Page 10: Health Status
Health status • The use of the c-med° alpha monitoring system cannot replace the consultation with your doctor� • The System is intended to be used in hospitals, clinics, long-term care, and home care environments where the variations of the measured values could not result in immediate danger to the patient.
Page 11 • Persons over 60 years of age. • Persons with diabetes mellitus or a weakened immune system (e.g. HIV positive, cancer chemotherapy, chronic steroid treatment, splenectomy). • Bedridden patients (e.g. Nursing home patients, stroke, chronic illness and/or after surgery). • Transplanted patients (e.g.
Page 12: Usage And Application
Usage and application • 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 13 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 14 accuracy of the IR-thermometer. • At ambient temperatures of 40 °C (104 °F), self-heating of 1 – 2 °C (1.8 – 3.6 °F) can increase the in-ear sensor temperature to max. 42 °C (107.6 °F). • When this instrument is operated under the minimum amplitude of 0.2 or above the maximum amplitude of 1.0 for the Perfusion-index the SpO2 results are possibly inaccurate�...
Page 15 bathing or swimming as long as there is still water inside the ear canal� • Do not use the in-ear sensor under water (bath, shower, swimming). • Do not use the in-ear sensor during a magnetic resonance imaging. • Do not use the in-ear sensor in places where electrical equipment is prohibited, e.g.
Page 16 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. Warnings and precautions...
Page 17: Usage On The Go
• Do not leave the charging cable unattended with small children, there is a danger of strangulation. • Keep the c-med° alpha out of reach from pets and pests. • Keep the c-med° alpha out of reach from children. Usage on the go •...
Page 18: Bluetooth
• When using the device on the go, be aware of any impairment of your sense of balance or hearing. Especial- ly when driving or operating machinery. • Please note that in an environment where network communication is not possible, initial connection of the device may not be possible.
Page 19 Such devices may experience interference when a Bluetooth connection is established nearby� • 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 20: Influencing Factors
Influencing factors WARNING: Influencing factors Important influencing factors that can lead to incorrect vitals signs measurements: • A dirty sensor head • A damaged sensor • Unnecessary movements • Chewing • Talking Important environmental conditions that can lead to incorrect vitals signs measurements: •...
Page 21 - be aware that this may result in less accurate body temperature measurements. If the device is used outside the specified operating conditions, cosinuss° can not guarantee the accuracy of the measured vital signs� Influencing factors...
Page 22: External Influencing Factors
External influencing factors • Direct exposure to cold, heat, wind, sun and water • Ambient temperature • Ambient light • Body Movement in general • Strong movements of the jaw due to speaking and chewing • Lying on your ear •...
Page 23: Normal Body Temperature
• Poor blood circulation • Poor pulse quality • Poor Perfusion • Venous pulsations • Dark skin color • Anemia or low hemoglobin concentrations • Sickle cell anaemia • Cardiogreen and other intravascular dyes • Carboxyhemoglobin • Methemoglobin • Dysfunctional hemoglobin Normal body temperature The “normal”...
Page 24: Normal Heart Rate
NOTE: When you talk to your doctor, tell him that the temperature you have monitored with c-med° alpha is a temperature monitored continuously with an infrared thermometer in the ear. and varies throughout the day. The c-med° alpha is suitable as a continuous monitoring in-ear sensor for measuring the body temperature.
Page 25: Normal Oxygen Saturation (Spo2)
Normal oxygen saturation (SpO2) The oxygen saturation indicates the percentage of oxygen in the blood. In a healthy adult the normal oxygen saturation is 95 – 99%. Oxygen saturation can be influenced by various factors, including air pressure (different altitudes) or certain c-med°...
Page 26: Signs And Symbols
EC Directive on Electrical Waste. cosinuss° makes an annual contribution to the environmentally friendly disposal of its products.
Page 27 Question Mark: Vital signs data not valid according to quality index� Follow the instructions for use. Product with application parts of type BF (Body Floating). Product with protection class II. Manufacturer. Production batch number. Model identifier. c-med° alpha in-ear sensor. c-med°...
Page 28 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)� Language requirement English: Meets the mandatory language requirements for medical devices in English.
Page 29: Scope Of Delivery
Unique device identification (UDI): Indicates a carrier that contains Unique Device Identifier information. Serial number (SN): Indicates a carrier that contains unique serial number. Size: Small (S) (Tip size Ø 0.39 in = 10 mm). Size: Medium (M) (Tip size Ø 0.45 in = 11,5 mm). Size: Large (L) (Tip size Ø...
Page 30: Product Description
• c-med° alpha in-ear sensor (MS01) • c-med° App (Download) • c-med° charging box (MC01) • Power supply (USB charger adapter) • Charging cable (USB / Micro-USB) • User manual Product description Intended Use The c-med° alpha is intended to be used as a medical measuring in-ear device for body temperature, pulse rate and blood oxygen saturation.
Page 31: Intended Patient Population
transfers and /or visualizes the stated parameters of healthy or sick persons starting at the age of 18. As a reusable and wearable device, the intended operator is any adult person without neurodevelopmental or neurocognitive disorders. Intended operator The intended user can be any adult person without neurode- velopmental or neurocognitive disorders.
Page 32: Performance
WARNING: Vital signs Only the following vital signs can be measured using the c-med° alpha: • Body temperature • Heart rate • Blood oxygen saturation (SpO2) Performance • Measurement of body temperature in the ear canal • Measurement of heart rate in the ear canal •...
Page 33 and home care environments where the variations of the measured values could not result in immediate danger to the patient� The device can also be used outdoors given that the ambient temperature specifications are not exceeded, and the ear is covered and protected from wind and direct sun radiation�...
Page 34: Contraindication
Application Programming Interface (API) specifica- tions. For more information or if you want to integrate the c-med° alpha in your own system, contact cosinuss°. Contraindication The product c-med° alpha shall not recommend any concrete treatments and shall not be used : •...
Page 35: Alternative Measurement Methods
Alternative measurement methods Depending on the design, these other methods or devices can be applied to different parts of the body and may result in different readings. Please follow the instructions for use of the respective device. For a continuous monitoring of these vital signs each spot measurement procedure needs to be done repeatedly�...
Page 36: Pulse Rate
Pulse rate Pulse rate can be measured manually or by means of special devices. The pulse rate can be measured manually by “palpation” with the fingers at all points on the body where arteries run superficially. The best-known palpation site is in the area of the wrist (radial pulse).
Page 37: Application Principle
Application principle The in-ear sensor can only be used in combination with its charging box, a mobile device of the respective user and the installed App. The medical device is intended for the continuous and non-invasive body temperature, pulse rate and SpO2 measurement in the human auditory canal.
Page 38: Technical Principle
Application principle of the c-med° alpha. 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.
Page 39 surrounding auditory canal. Due to the so-called thermopile sensor the incident thermal radiation can be converted into a voltage signal (principle of the thermoelectric effect). Through calibration and with the help of a proportional to absolute temperature sensor (PTAT1) element which measures the ambient sensor-temperature it is then possible to determine the absolute temperature of the measured object or, more specifically, the eardrum plus the surrounding...
Page 40: Photoplethysmography (Ppg) Sensor
Photoplethysmography (PPG) sensor The c-med° alpha measures the oxygen saturation inside the ear by pulse oximetry using a PPG sensor. Two LEDs, one with red light, one with infrared light, will be used to send light into the tissue of the ear canal. A photodiode will capture the light coming out of the skin, convert the light into electrical current.
Page 41 Accuracy of SpO2 The SpO2 shall be measured with an accuracy of ARMS ± 3% 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 42 movement in healthy volunteers (Men and women, adult age, non-smoking, normal weight, skin tone according to Fitzpatrick scale) within a range of 70%-100% SpO2 and in reference to a secondary standard pulse oximeter. In this desaturation study the c-med° alpha achieves an overall accuracy of ARMS = 3 % when compared to blood gas analysis.
Page 43: Why Inside The Ear
Why inside the ear? The ear canal is an ideal place of measurement for vital sign monitoring: Blood supply: The ear canal is part of the body core and therefore optimally supplied with blood. This is essential for all optical measure- ments on the body and ensures the possibility for a data collection of high accuracy.
Page 44 which is critical for accurate measurements with this method anywhere on the body� Dark surrounding: The place of measurement is already minimizing the ambient light that falls into the receiving photodiode. This is essential for reducing noise artefacts in the received signal and improves the overall signal quality.
Page 45: Application Environment
Application environment The optimal condition for the device use is an indoor, wind- protected environment without direct sunlight, such as in hospitals, clinics, long-term care, and home care environ- ments where the variations of the measured values could not result in immediate danger to the patient. However, the device can also be used outdoors given that the ambient temperature specifications are not exceeded, and the ear is covered and protected from wind and direct sun...
Page 46 - be aware that this may result in less accurate body temperature measurements. If the device is used outside the specified operating conditions, cosinuss° can not guarantee the accuracy of the measured vital signs� HINWEIS: If you use the c-med° alpha to measure the body temperature outdoors, please ensure that the ear (measurement site) is covered according to the temperature conditions.
Page 47: Transport And Storage Environment
Transport and storage environment For domestic use the in-ear sensor and the charging box shall be stored and transported under the following condi- tions - other environments may influence the accuracy of the IR-thermometer and PPG-sensor. Temperature Relative Humidity -25 °C – 5 °C (-13 °F – 41 °F) 5 °C –...
Page 48: Components
Components The c-med° alpha can only be used in combination with its charging box, a mobile device of the respective user and the installed App. The medical product is intended for the continuous and non-invasive body temperature, pulse rate and SpO2 measurement in the human auditory ear canal. Ort der Messung im äußeren Gehörgang.
Page 49: In-Ear Sensor
In-ear sensor 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 Components...
Page 50 Available Tip sizes The c-med° alpha in-ear sensor is available in three sizes: Small, Medium and Large. These differ only in the diameter of the sensor tip. The sensor tip is flexible and can adapt to the ear canal. The quality of the measurement depends largely on choosing the right size for your ear canal.
Page 51 In-ear sensor & LED states The LEDs of the c-med° alpha have the following possible states: Status-LED LED-behavior Description When switching on Green 100-51% Battery charge level Orange 50-26% Battery charge level 25-6% Battery charge level (blinking) < 6% Battery charge level In activated state Blau (blinking)
Page 52: Mobile Application
WARNING: Defective sensor / Hardware error Do not use the in-ear sensor, if it is defective. Hardware errors are occurring, if: • The Status-LED lights up permanently red. • The device has visible damages. Charging LED LED behaviour Description Solid red In-ear sensor is charging�...
Page 53 NOTE: The c-med° alpha is intended to be used with the c-med° App. A connection via other applications or systems is only intended if the respective second system adheres to the cosinuss° API specifications. For more information or if you want to integrate the c-med°...
Page 54 Vital signs screen The c-med° alpha in-ear sensor for vital signs monitoring. 1 Menu opening navigation drawer to 6 Heart rate value (bpm) access all app destinations 7 Quality index 2 Serial number and in-ear sensor type 8 SpO2 value (%) 3 In-ear sensor battery status 9 Perfusion index 4 Bluetooth connection status...
Page 55: 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°...
Page 56: The Charging Box
electromagnetic compatibility. • 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.
Page 57: The Power Supply And Charging Cable
The power supply and charging cable The c-med° alpha charging box. 1 USB socket 4 USB plug 2 Power supply 5 Micro USB plug 3 Euro plug 6 Charging cable Accessories...
Page 58: Operation
Operation Before initial operation These preconditions are best practice to ensure before operation� • Check for physical damage of device and accessories. • Charge the c-med° alpha in-ear sensor to full capacity. • Charge your mobile device to full capacity. •...
Page 59 Open the App • Turn ON Bluetooth on your mobile device. • Start the c-med° App on your mobile device. Identify the in-ear sensor • Find the serial number labeled on your in-ear sensor� • Enter the serial number in the App. •...
Page 60 NOTE: In-ear sensor and mobile device must be within the Bluetooth maximum range of 10 meters. See chapter: Warnings and precautions > Bluetooth Follow instructions on screen. • Follow the instructions on screen� • The app will guide you through all steps needed to receive and monitor your data.
Page 61: 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. Operation...
Page 62 • Adapt the neck of the in-ear sensor to the shape of the ear. WARNING: Sensor Size • A wrong sensor size can lead to incorrect measurements. • Avoid excessive and deep pressure during application� NOTE: • The sensor head may just disappear into the auditory canal. •...
Page 63: Monitoring Vital Signs
Monitoring vital signs Status bar specification The c-med° App shows the in-ear sensor information of current battery level and the current Bluetooth connection status in the status bar on top of the vital signs monitoring screen� Concept of the status bar. Status bar behavior After verifying your in-ear sensor the status bar shows the serial number and sensor type in the status bar in order to...
Page 64 During an active Bluetooth connection the in-ear sensor information of battery level and connection status are dynamically updated. Battery 20 – 100 % Battery 0 – 20 % Battery level unknown Bluetooth connected Searching for Bluetooth connection Bluetooth disabled/disconnected WARNING: Bluetooth •...
Page 65: Vital Sign Cards Specification
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.
Page 66 If the displayed value is not reliably determined due to a signal insufficiency, a question mark is displayed. Value is valid. Value: High emphasis. Perfusion index: Low emphasis. Value is not valid. Notification: Question mark. Value: Low emphasis. Perfusion index: High emphasis. No value In case of: •...
Page 67 WARNING: Thresholds and indicators Update of vital signs Every 1 second Expiration of vital signs Every 1 second Poor Quality of Heart Quality lower than 30 Rate (Question mark) Poor Quality of SpO2 Perfusion lower than 0.2 (Question mark) Perfusion higher than 1.0 NOTE: The measurement at rest provides the best results.
Page 68 Check signal quality • Check quality index and perfusion index • Assess if the vital signs calculation is reliable. • Improve the signal quality by avoiding • influential factors. See chapter: Warnings and precautions Quality index Quality index for the Photoplethysmography (PPG) signal is an indicator for the reliability of the currently calculated heart rate values�...
Page 69: Shutdown
NOTE: • The reliability of the signal can also be an indicator for a good fitting sensor size. • The reliability of the signal is also affected by different influencing factors. See chapter: Warnings and precautions Shutdown Close the App •...
Page 70: Charging
Charging 1� Put the in-ear sensor into its charging box� 2� The in-ear sensor turns OFF� 3� Connect the charging cable to the charging box� 4� Connect the power supply to the charging cable� 5� Plug the power supply into a power socket. 6�...
Page 71: Health Data
Health data Cosinuss GmbH Cosinuss Gmbh is a certified medical device manufacturer and meets all requirements for quality management of the harmonized standard ISO 13485. The c-med° alpha and the associated software is a class IIa medical device and conforms to the MDR 2017/745/EU - Medical Device Regulations and IEC 62304.
Page 72: Data Privacy And Data Security
Cosinuss GmbH assures that it will always strive to improve its products in terms of quality, usability and safety. Data privacy and data security We take the protection of your personal data very seriously.
Page 73 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 74: 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 75: Connection And Transmission
Connection and transmission PROBLEM INDICATOR REASON SOLUTION The c-med° alpha The sensor stays The Bluetooth Turn ON Bluetooth does not connect in advertising function of the on the mobile to the app. mode. Status LED mobile device is device and retry� blinks blue.
Page 76: Vital Signs Display
Vital signs display PROBLEM INDICATOR REASON SOLUTION No vital signs are The app shows no No in-ear sensor Connect your displayed. value (--�-)� connected� sensor� No in-ear sensor in See chapter: Bluetooth range� Warnings and precautions > Bluetooth No new values Check Bluetooth incoming since 30 connection�...
Page 77: Wearing Comfort
Wearing comfort PROBLEM INDICATOR REASON SOLUTION The in-ear sensor Individual Wrong fitting. Check the correct hurts. perception� fitting of the in-ear sensor� See chapter: Apply the in-ear sensor to the ear Wrong in-ear Check the long sensor size. term behavior of the quality indices�...
Page 78: Care And Cleaning
PROBLEM INDICATOR REASON SOLUTION The in-ear sensor Individual The monitored Cancel the hurts. perception� person’s ear is measurement. injured. See chapter: Warnings and precautions Care and cleaning Care Take good care of your c-med° alpha to ensure a long lasting performance.
Page 79: 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’ and wipes as an alcohol-based cleaning agent� Alternatively, any other disinfectant/disinfectant wipes based on a total of 60% (w/w) alcohol with no fragrances can be used in undiluted application�...
Page 80 • Fixate the sensor head between your fingers. • Clean the sensor head with a cotton swab soaked in disinfectant (Schülke Mikrozid® AF liquid). • Remove other visible dirt with a disinfectant wipe (Schülke Mikrozid®). • Distribute disinfectant evenly over the entire in-ear sensor�...
Page 81 • Let the disinfectant work for about 1 minute • Take another disinfectant wipe (Schülke Mikrozid®). • Rub the surface well in all areas to mechanically clean the surface. • To disinfect the area under the sensor head, you should use a cotton swab to guide the disinfectant wipe under the head and carry out the disinfection while...
Page 82 Charging box • Clean the charging box with • a disinfectant wipe (Schülke Mikrozid®). Care and cleaning...
Page 83: 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 Heart rate, oxygen saturation (SpO2), (parameters) body temperature. Status indicators RGB-LEDs Vital signs display Mobile application (App): Current temperature (°C / °F), heart rate (bpm) and SpO2 (%) in numbers.
Page 84 Tip sizes available Small (S) (Tip size Ø 0.39 in = 10 mm) Medium (M) (Tip size Ø 0.45 in = 11,5 mm) Large (L) (Tip size Ø 0.49 in = 12,5 mm) Weight Approx� 7 g Material Silicone rubber, medical grade - ISO 10993-5 /-6 /-11 - USP class VI Color White...
Page 85 5 °C – 35 °C (41 °F – 95 °F) | 0% – 95% rH (non-condensing); 35 °C – 70 °C (95 °F – 158 °F) | at a water vapor pressure up to 50 hPa Protection type IP47 solid foreign bodies with diameter ≥ 1.0 mm, submersible to a depth of 1 m Type of applied part Service life...
Page 86 Radio data transmission Type Bluetooth Low Energy (BLE) Version 5.0 (backwards compatible to 4.2) Frequency ISM band 2.4 – 2.485 GHz Transmitting power ≤ 0 dBm Supported services Battery Service, Device Information Service, Health Thermometer Service, Heart Rate Service, Pulse Oximeter Service, Custom Profile Encryption Advanced Encryption Standard (AES)
Page 87: 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 Pulse rate, body temperature, SpO2 Photoplethysmography (PPG) sensor Type Red LED, infrared LED and photodiode Method Photoplethysmography (PPG)
Page 88 Infrared temperature sensor Type Infrared temperature sensor, contactless Measuring range Calibrated in the ambient temperature range from 15 - 40 °C (59 - 104 °F). Resolution 0.01 °C (0.05 °F) Technical accuracy ±0.2 °C (±0.4 °F) within 35.0 – 42.0 °C (95 – 107.6 °F) Sampling rate Variable, standard 0.1 Hz Accelerometer...
Page 89: Vital Signs
Vital signs Body temperature Type Infrared thermometer, Direct mode (no Adjusted mode available) Measuring range 34 °C – 43 °C (93.2 °F – 109.4 °F) Resolution 0.1 °C (0.2 °F) Accuracy (Laboratory) ± 0.3 °C (± 0.5 °F) within 34.0 – 35.0 °C (93.2 – 95 °F) ±...
Page 90: Accessories
Heart rate Type Measuring range 35 bpm – 220 bpm Resolution 1 bpm Accuracy ± 4 bpm Interval Variable, standard 1 Hz Oxygen saturation (SpO2) Type Measuring range 70 % – 100 % Resolution Accuracy ± 3 % Interval Variable, standard 1 Hz Accessories Charging box MC01...
Page 91 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 Socket Micro-USB B Power supply Model FJ-SW2050501000E (Type C), FJ-SW2660501000E (Type C) Protection class...
Page 92 Model M050120-S86EUU (Plug-type C), M050120-S86BSU (Plug-type G), M050120-S86USU (Plug-type A) Protection class Usage Power supply, voltage transformer Input 100 – 240 V ~ 50/60 Hz, 0.5 A Max.. Output 5 V, 1200 mA Plug Plug-type C (CEE 7/16), Plug-type G (BS 1363), Plug-type A (NEMA 1) Socket USB A...
Page 93 Mobile 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 The software download is free with the purchase of installation the hardware product� • Google Play Store for Android •...
Page 94 Standards and regulations DIN EN ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. EN ISO 80601-2-56: Particular requirements for the safety, including essential performance, of medical thermometers for measuring body temperature. EN 60601-1: Medical electrical equipment - Part 1: General requirements for safety, including essential performance.
Page 95 DIN EN ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied� EN 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for safety, including essential perfor- mance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems for household medical use.
Page 96 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 responsi- ble for compliance could void the user’s authority to operate the equipment.
Page 97 contains license-exempt transmitter(s)/ receiver(s) that comply with Innovation, Science and Economic Development Canada’s license-exempt RSS. Operation is subject to the following two conditions: L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique Canada applicables aux appareils radio exempts de licence.
Page 98 Training and Supporting Instruction The manufacturer recommends completing and conducting training in accordance with §4 MPBetreibV (applicable in Germany). In order to make this easier, cosinuss° provides supporting instructions: https://training.cosinuss.com/en If you have any questions regarding the correct use of the product please contact cosinuss°...
Page 99 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�...
Page 100 Unique Device Identification The Unique Device Identification (UDI) is a machine-readable tag that serves as a key to a UDI database.The Cosinuss GmbH as manufacturer identifies the entire product and associated parts with this code. This allows cosinuss° to trace back the origin of the product in case of a malfunction, defect or recall.
Page 101 Sensor UDI PART NUMBER IDENTIFIER LENGTH DESCRIPTION GTIN (country prefix, (01) 13+1 Contains information manufacturer number, regarding the product article number, check and manufacture digit) (+country) to identify the product worldwide Manufacturing date (11) Format: yymmdd (10) Model of sensor device (e�g�: MS01) (10) Identification to track...
Page 102 App UDI PART NUMBER IDENTIFIER LENGTH DESCRIPTION GTIN (country prefix, (01) 13+1 Contains information manufacturer number, regarding the product article number, check and manufacture digit) (+country) to identify the product worldwide Application identifier (8012) c-med° App version (Software version) X�xx will update with number) every new release Unique device identification...
Page 103 Serial number The serial number consists of the last 6 digits of the UDI. cosinuss° uses this number to verify the c-med° alpha monitoring system during its usage. Where to find the serial number? The serial number can be easily found: •...
Page 104 To claim the warranty please address your seller. If the purchased item is defective, you are entitled to the following rights, whereby supplementary performance has priority: • Supplementary performance • Reduction of price • Withdrawal • Compensation (for futile expenses) WARNING: Disposal This product contains batteries and recyclable electrical waste: •...
Page 105 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.
Page 106 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 person- al data or the product� There are no replaceable parts in the in-ear sensor. Compo- nents supplied must not be exchanged.
Page 107 Where to find labeling information? Sensor: • CE marking, • LOT number, • TYP/Model number • Serial number • Size indicator • 2D data matrix Charging box: • Serial number • 2D data matrix • IP class • CE marking •...
Page 108 Sales Label: • 2D data matrix • 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 •...
Page 109 www.cosinuss.com...

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