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Ottai M8 User Manual

Continuous glucose monitoring system
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CONTINUOUS GLUCOSE
MONITORING SYSTEM
User Manual

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Summary of Contents for Ottai M8

  • Page 1 CONTINUOUS GLUCOSE MONITORING SYSTEM User Manual...

  • Page 2: Important Note

    IMPORTANT NOTE 01. Please ensure you have fully read and are familiar with the User Manual before using the Ottai Continuous Glucose Monitoring System. Failure to follow instructions may result in pain or injury and may affect product performance. 02. Please remove the Sensor before performing MRI, X-ray, or CT examinations.

  • Page 3: Download App

    Ottai CGM Quick Guide STEP 01 DOWNLOAD APP Scan the QR code to download the "Ottai" App, or search for "Ottai" in the mobile App Store to download. Please make sure your mobile phone: 1. The operating system is Android 5.0 and above, or IOS 13.0 and above;...

  • Page 4: Register & Login

    STEP 02 REGISTER & LOGIN...
  • Page 5 STEP 03 TAKE OUT THE DEVICE Open the product packaging and take out the device. Caution: Do not use the device if the sealed bag or the device itself is broken. Please contact customer service. STEP 04 SELECTION OF APPLICATION SITE Choose the rear area of your upper arm as the application site.

  • Page 6: Cover Removal

    STEP 05 CLEAN APPLICATION SITE Clean the application site with alcohol pads and wait until the skin becomes dry before proceeding to the next step. STEP 06 COVER REMOVAL Rotate open the bottom cover of the Applicator.
  • Page 7 STEP 07 SAFETY CAP REMOVAL Remove the safety cap on the top of the Applicator. Caution: Do not touch the button under the safety cap yet. STEP 08 LAUNCHING Place the Applicator over the cleaned area of the arm, press the launch button on the top, and gently pull away the Applicator.
  • Page 8 STEP 09 TAPE FIXING Gently press the tape around the Sensor to attach it firmly to the skin. Once done, follow the instructions on your mobile screen to start the Sensor. STEP 10 CONNECT Please keep the back of your mobile phone close to the Sensor until you hear beep sounds or sense vibrations.
  • Page 9 STEP 11 WARM-UP A 60-minute warm-up period is required before the glucose data can be displayed. REMOVE MONITOR Your Sensor should be removed after 14 days (336 hours). When removing the Sensor, gently pull the adhesive upwards from the side, then slowly remove the Sensor from the site.

  • Page 10: Before Use

    User Manual Thank you for your trust in the Ottai CGM product. We hope to present you the best experience and service with our Continuous Glucose Monitoring (CGM) System. Before using the CGM System, please ensure that you have fully read and familiarized yourself with the Instructions for Use.
  • Page 11 04) Warnings: to remind you of any severe or life- threatening environment that needs to be avoided when using the product as well as corresponding consequences and the way for danger avoidance. Upon unpacking the product, check whether the product is intact. If any parts are missing or damaged, please contact customer service at 400-0860-509.
  • Page 12 only when supervised by a caregiver who is at least 18 years of age. 1.4 Warnings 01) Do not use the Sensor if the packaging has been damaged or opened. 02) Do not use the damaged or broken Sensor for fear of any potential electrical safety hazards or electric shock injuries resulting from failures.
  • Page 13 ionizing radiation. 03) Do not reuse this single-use product or share it with others. 04) Do not freeze this product. 05) Do not expose this product to direct sunlight or high temperature. 06) Do not apply the Sensor onto sites that may be frequently rubbed by clothing, have scars, or with frequent movement.
  • Page 14 14) Do not change or modify the device. Changing or modifying the device can result in improper insertion, pain, or injury. 15) The accuracy of glucose monitoring in patients with severe anemia and abnormal erythrocyte pressures was not validated to ensure the reliability of the measurements.
  • Page 15 1.6 RF Communication The Continuous Glucose Sensor will generate, use, and radiate RF energy and may cause harmful interference to radio communications. So, interference may be inevitable in a particular usage environment. The Sensor uses RF energy only for its internal communication with the smart device.
  • Page 16 2. Introduction to Ottai CGM System 2.1 Name and Model Name: Continuous Glucose Monitoring System Model: M8 Trade name: Ottai 2.2 Working Principle The Continuous Glucose Monitoring System uses electrochemical sensor to monitor glucose levels in interstitial fluid. Based on the electrochemical reaction...
  • Page 17 indicated for measuring interstitial fluid glucose levels in intended adult users and can provide users with real- time glucose readings, glucose trend and fluctuation characteristics, and alert information such as high/low glucose alerts. The results measured by the product should not be used as the basis for determining or adjusting the treatment regimens for patients with diabetes.
  • Page 18 rotating it counterclockwise. 04) Remove the safety cap on the top of the Applicator. Caution: Do not touch the button under the safety cap yet. 05) Place the Applicator on the cleaned area of the arm, press the launch button on the top and gently pull away the Applicator.
  • Page 19 3. Introduction to the Continuous Glucose Monitoring System Software 3.1 Functional Overview The Continuous Glucose Monitoring System Software (hereinafter referred to as APP) is a component of the Continuous Glucose Monitoring System and can only be used in conjunction with the Continuous Glucose Monitoring System device.
  • Page 20 provide an application program interface for external requests. 02) Network Interface - Intended User: Individuals who use CGMS for glucose management. - Intended use: To export glucose reports at the end of the session. - Technical features: The Continuous Glucose Monitoring System software uses the https network protocol to communicate securely with the server.
  • Page 21 the Administration of Registration and Filing of Medical Devices", "Rules for Naming the Common Names of Medical Devices", "Provisions on the Administration of Instructions and Labeling of Medical Devices", "Guidelines for Technical Review of the Registration of Medical Device Software", "Guidelines for Technical Review of the Registration of Medical Devices for Cybersecurity", and "Guidelines for Technical Review of the Registration of Mobile Medical...
  • Page 22 APP which can be maintained by our company, and our company reserves the right to interpret this. Ottai Technology Wuxi Pty., Ltd. will maintain the product by updating the APP. Uninstalling APP Long press the icon of APP on the desktop of the mobile computing terminal where APP is installed, and "Uninstall"...
  • Page 23 3.4 APP Operation First Time Users 01) Registration and Login After installing the APP according to the requirements, open the APP on the desktop of the mobile computing terminal, register a new account and log in to the APP account. 02) Complete personal information Follow the instructions in APP to complete your personal information, including date of birth, gender, height, weight,...
  • Page 24 Glucose Change Indicator Arrow The change in glucose is greater than 2mg/dL or ↑ Glucose in rapid rise 0.11mmol/L per minute The change in glucose varies in the range of 1-2mg/ ↗ Glucose in slight rise dL or 0.06-0.11mmol/L per minute The change in glucose is less than 1mg/dL or →...
  • Page 25 target glucose range, the APP sends an alert message to the user. Personal Center In the "App - My" section, you can view my device, device status and remaining time. Tap the arrow on the right side of your avatar to view your personal information, including nickname, date of birth, gender, height and weight.
  • Page 26 Operating Environment Please refer to 3.1 Interface Description in this manual. 3.6 Software Quality 3.6.1 Functionality See section 3.4 of this manual for details. 3.6.2 Performance efficiency Under the operating environment of the APP described in these instructions, new glucose data can be displayed every 5 minutes on the "Monitoring"...
  • Page 27 03) Ability to read English or Arabic numerals. Prompt messages in the app include: 01) If users enter an incorrect verification code during login, a prompt will display 'Incorrect verification code.' 02) If Bluetooth is turned off, a prompt will indicate 'Bluetooth is not enabled;...
  • Page 28 4. Termination of Glucose Monitoring (removal, replacement of Sensors) When using the Continuous Glucose Monitoring System, the APP will indicate the remaining time of product usage on the homepage, you can purchase or replace the Sensor in advance according to the remaining time of usage, so that you can continuously monitor your glucose changes.
  • Page 29 Note: You can take action to terminate the glucose monitoring operation early when the following situations occur: 01) The Sensor is not in its normal service life; 02) The Sensor is detached or the adhesive is detached; 03) Other objects are rubbing against the Sensor (e.g., seat belt, etc.);...

  • Page 30: Sensor Specifications

    5. Sensor Specifications 2~25 mmol/L Glucose concentration detection range Sensor size (Diameter*Height) 24mm*3.5mm Insertion depth of Sensor Sensor power supply lithium battery (3V) 14 days Sensor service life Transmitter memory Stores up to 14 days of data Operating temperature 5~40 ℃, no freezing Operating relative humidity 10 %~85 % RH, no condensation Storage and shipping temperature range...

  • Page 31: Maintenance And Repair

    6. Maintenance and Repair 6.1 Warranty and Maintenance This product is warranted to be free from defects in material and workmanship for 12 months from the date of manufacture. During the warranty period, this product will be replaced at the discretion of the equipment. This product warranty applies only to new equipment and shall not be extended if the Sensor is replaced.
  • Page 32 7. Circuit Diagrams and Component Lists All parts in the composition of this product can only be returned to the factory or by the company's designated professionals to repair, non-professionals may not repair this equipment. If the user needs technical information such as circuit diagrams, component lists and diagram notes from the manufacturer, it is necessary to contact the manufacturer for consultation to obtain them.

  • Page 33: Electrical Safety

    8. Electrical Safety Safety Features of the Sensor Classification by type of protection against Internal power supply units electric shock Classification by degree of protection BF-type application sections against electric shock Classification by the degree of protection IPX8 against incoming fluids Classification by degree of safety when Equipment not to be used in the presence used in the presence of flammable...

  • Page 34: Electromagnetic Compatibility

    9. Electromagnetic Compatibility 9.1 Guidelines and Manufacturer's Instructions - Electromagnetic Emissions Guidelines and Manufacturer's Declarations - Electromagnetic Emissions The Continuous Glucose Monitoring System is intended for use in the electromagnetic environment specified below, and the purchaser or user shall warrant that it is used in such electromagnetic environment Emission Test Compliance Electromagnetic Environment - Guidelines...
  • Page 35 Power Input Line <5%UT, lasting 0.5 The net power supply should Voltage weeks (with be of a quality typically used in a commercial or Dips, Short-term >95% temporary hospital environment. If reduction in UT) Interruptions and users of the continuous Voltage 40%UTT, lasting 5 glucose monitoring system...
  • Page 36 Guidelines and Manufacturer's Declarations - Electromagnetic Immunity The Ottai Continuous Glucose Monitoring System is intended for use in the electromagnetic environment specified below, and the purchaser or user shall ensure that it is used in such electromagnetic environment. Immunity IEC 60601...
  • Page 37 9.3 Recommended safety distances Recommended Isolation Distances for Portable and Mobile RF Communications Equipment and Ottai Continuous Glucose Monitoring Systems The Continuous Glucose Monitoring System is intended for use in an electromagnetic environment where radio frequency radiation disturbances are controlled. Depending...
  • Page 38 Active medical devices are subject to special EMC precautions and must therefore be installed and used in accordance with these guidelines. Portable and mobile communication RF equipment may affect the use of medical electrical equipment. The device or system may be interfered with by other devices, even if the other devices comply with the emission requirements of the respective national standards.
  • Page 39 Permission to be activated. Required permission for Activate the corresponding Ottai has not been activated permissions according to on the mobile phone. the instructions. APP crashed or freezes. Smart device system crash.
  • Page 40 Device start-up failed The device is not properly Check the Instruction For installed due to improper Use of the Sensor or contact operation. the customer service. Check if the device is outside Relocate the Sensor to the specified temperature. the specified operating temperature (2°C (36°F) - 45°C (113°F)) and turn it on again.
  • Page 41 11. Basic EMC performance The Continuous Glucose Monitoring System provides real-time monitoring of glucose.
  • Page 42 12. Information on Clinical Trials Clinical Trial Overview This product has been evaluated through clinical trials. The clinical trial was designed with a prospective, multicenter, single-group target value method. The experimental range was adult diabetic patients, and the product was worn on the lateral margin of the biceps muscle on the back of the upper arm, making the use period 14 days.
  • Page 43 The Sensor Stability The 20/20% concurrence rate was higher than 90% for all time staging except for the late stage (day 14) where the 20/20% concordance rate was 86.8%. The mean MARD values for the anterior (day 1), anterior- intermediate (days 2-5), intermediate (days 6-9), middle- late (days 10-13), and late (day 14) phases were 8.591% ±...
  • Page 44 to 4.4 mmol/L or 79 mg/dL, and the range for the high glucose reminder was set to 11.1 mmol/L or 200 mg/dL. The performance evaluation of high and low glucose alerts includes the success rate and failure rate of high and low glucose alerts (i.e.
  • Page 45 alert during the above period. 04) High glucose detection success rate and failure rate (i.e. specificity). High glucose detection success rate is the proportion of EKF also detecting high glucose within 30 minutes before and after the continuous glucose monitoring system prompts a high glucose event. The high glucose detection failure rate is the proportion of EKF that does not detect high glucose within 30 minutes before and after the continuous glucose...
  • Page 46 high/low glucose alert thresholds according to their own glucose conditions. 03) In the clinical trial of this product, in the subgroups with glucose <3.9mmol/L or 70mg/dL and <4.4mmol/L or 79mg/dL, the proportion of measurement points falling in the A+B area of the Clarke error grid analysis was less than 90%.

  • Page 47: Appendix 1: Markers And Symbols

    Appendix 1: Markers and Symbols Single use only. Do not re-use Do not use if package is damaged Attention! See Instructions for Use Radiation Sterilization Type BF Applied Part Do not throw in trash can Non-Ionizing Radiation Keep Dry Keep away from Direct Sunlight Temperature Limit Humidity Limit Serial Number...
  • Page 48 Annex 2: Glossary of Terms CGMS Continuous Glucose Monitoring System (CGMS) is a monitoring technology that indirectly reacts to blood glucose level by monitoring the glucose concentration of subcutaneous interstitial fluid through glucose sensors, which can provide continuous, comprehensive, and reliable information on blood glucose throughout the day, understand the characteristics of blood glucose fluctuations, and detect hidden hyperglycemia and hypoglycemia that are not easy to be detected by traditional...
  • Page 49 Production / Expiry date See product label. Date of manufacture / Expiry date See product label. Registrant / Manufacturer's Name Ottai Technology Wuxi Pty., Ltd. Registrant's residence Building 530, 18 Qingyuan Road, Xinwu District, Wuxi, P.R.CHINA Manufacturing Address Room 210, East 2F, Building 3, No.58 Jinghai Road, Beijing...
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