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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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Алла
May 31, 2025

Здравствуйте, по ошибке изменила единицу измерения, было удобнее с привычным, где значение для России с нормой до 8 моль, значение слева

User image 683a7dfc8860e
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Евгения
May 10, 2025

Как записать еду

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Сергей
May 19, 2025

Купил Ottai V 8 на озоне с китая при сканировании выдает Код 103102. что делать ?

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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 03. Product measurement results are not used as a basis for deciding and adjusting treatment plans for diabetic patients.

  • 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 the device. if the sealed bag or the device 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 proceeding to the next step. STEP 06 COVER REMOVAL 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 OVERLAY PATCH Each package has an overlay Patch to help with adhesion and stability.

  • Page 9: Connect Sensor

    STEP 11 CONNECT SENSOR STEP 12 WARM-UP A 30-minute warm-up period is required before the glucose data can be displayed.

  • 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 ensure that you have fully read and familiarized the local distributor 1. Before Use 1.1 Information on User Safety circumstances under which use of the product should yourself or damage the product.
  • Page 11 threatening environment that needs to be avoided when using the product as well as corresponding consequences and the way for danger avoidance. 1.2 Intended Use to be used as a basis for determining or adjusting the treatment plan for diabetic patients. 1.3 Contraindications caution.
  • Page 12 years of age. damaged or opened. injuries resulting from failures. 06) Do not ignore symptoms that may be caused by that do not match well with the Sensor glucose readings or suspect that your readings may be Sensor is damaged. 1.5 Precautions 02) Do not expose the Sensor to magnetic resonance...
  • Page 13 ionizing radiation. 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 frequent movement. of rubbing alcohol is allowed. mobile phone. used with other implantable medical devices (i.e.
  • Page 14 14) Do not change or modify the device. Changing or was not validated to ensure the reliability of the measurements. glucose reminder function has been evaluated through high and low glucose reminders were initially set at glucose>11.1mmol/L for high glucose reminders and glucose.
  • Page 15 1.6 RF Communication equipment. Communication between your Sensor and cause any inaccurate data or any damage to your device. suggested that the Sensor should be dried with a clean communicate properly while immerse in water since the product to water over 1.5 meter (4.92 feet) deep or for more than 30 minutes.
  • Page 16 2. Introduction to Ottai CGM System 2.1 Name and Model electrochemical sensor to monitor glucose levels in is oxidated by glucose oxidase on the sensor and the the electrochemical signal and outputs the analog signal. patient’s daily maximum and minimum glucose values as information on the orientation and rate of change of glucose trend.
  • Page 17 not be used as the basis for determining or adjusting the 2.4 Product Composition System device and Continuous Glucose Monitoring System Glucose Monitoring System device includes a Sensor (the transmitter and the sensor are integrated into one unit) and an Applicator. All for single use only. System Device 2.5 Device Installation complete and undamaged.
  • Page 18 Caution: Do not touch the button under the safety cap yet. press the launch button on the top and gently pull away the Applicator. 06) Gently press the adhesive tape on the edge of the Note:...
  • Page 19 3. Introduction to the Continuous Glucose (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 user can use the mobile computing terminal with the APP installed to connect with the Sensor via Bluetooth to obtain data.
  • Page 20 requests. management. session. management. Bluetooth 4.2 and above. 3.2 Compliance complies with the requirements of the following...
  • Page 21 3.3 Installation and Maintenance a. APP Operating Environment Android Operating Android 5.0 and iOS 13.0 and Lower than System compatible compatible AliyunOS 2.1903 1.4Ghz and 1.4Ghz and compatible versions compatible versions compatible versions compatible versions Storage 4.2 and compatible 4.2 and compatible Bluetooth versions versions...
  • Page 22 Apple App Store. from Android App Store. Note: provide professional technicians to maintain the version updating the APP. Uninstalling APP...
  • Page 23 3.4 APP Operation First Time Users account. 02) Complete personal information Follow the instructions in APP to complete your personal etc. 03) Connect the device Set the upper and lower target glucose range in order to monitoring data in real time. Note:...

  • Page 24: Glucose Statistics

    Glucose in rapid rise 0.11mmol/L per minute Glucose in slight rise Glucose in stable state 0.06mmol/L per minute Glucose in slight drop Glucose in rapid drop 0.11mmol/L per minute Arrow Sensor Connection Status minutes) 8h and 24h data graphs (default 24h view) minutes) Glucose Statistics to switch the date and view the statistics of glucose...
  • Page 25 the user. Personal Center the target glucose range. number and user agreement. User Access Control Mechanism APP only has basic access authorization users enter the software through cell phone number and SMS functions of the software. the database.
  • Page 26 3.6.1 Functionality See section 3.4 of this manual for details. Under the operating environment of the APP described APP. 3.6.3 Information Security glucose reminder and system settings is B level. 3.6.4 Compatibility old version. Only one version of the app can be installed concurrently with other software will not result in the loss of functionality or operational errors in the other software.
  • Page 27 03) Ability to read English or Arabic numerals. synchronized.' need to be granted. 3.6.6 Reliability historical data is automatically synchronized after Bluetooth is reconnected. 3.6.7 Maintainability...
  • Page 28 the APP will indicate the remaining time of product usage that you can continuously monitor your glucose changes. wear and no data can be obtained if the Sensor continues Sensor slowly and discard it safely.
  • Page 29 Note: monitoring operation early when the following recommended area. installing the Sensor.
  • Page 30 2~25 mmol/L Glucose concentration detection range Sensor power supply 14 days Stores up to 14 days of data Operating temperature Operating relative humidity Storage and shipping temperature range Storage and shipping relative humidity Atmospheric pressure 70~106KPa 60min Sensor sterilization method Sterilized using irradiation Modulation 2022DP20134...

  • Page 31: Maintenance And Repair

    6. Maintenance and Repair 6.1 Warranty and Maintenance product warranty applies only to new equipment and shall not be extended if the Sensor is replaced. by the requirements and does not apply to the following 01) Damage to the equipment caused by human 03) if the damage is caused by force majeure or other by the initial user shall result in the immediate termination requires no maintenance.
  • Page 32 manufacturer for consultation to obtain them.

  • Page 33: Electrical Safety

    8. Electrical Safety Safety Features of the Sensor Equipment not to be used in the presence anesthetic gases mixed with air or with oxygen or nitrous oxide. with oxygen or nitrous oxide. Continuous operation equipment equipment Does the device have a signal output or...
  • Page 34 9.1 Guidelines and Manufacturer's Instructions - such electromagnetic environment Emission Test Compliance Group 1 Emission GB 4824 electronic equipment. Continuous Glucose Monitoring Systems Class B Emission GB 4824 domestic and those not directly connected to the public low voltage supply grid of domestic GB17625.1 dwellings.
  • Page 35 be of a quality typically used in a commercial or users of the continuous glucose monitoring system require continuous operation 17626.11 then an uninterrupted power is recommended for the continuous glucose monitoring system. seconds (with 3 A/m 3 A/m Magnetic Field (50/60 17626.8 commercial or hospital environment.
  • Page 36 that it is used in such electromagnetic environment. Immunity IEC 60601 Level of Tests Test level Compliance frequency communications equipment is prohibited Conduction continuous glucose monitoring system (including cables) than their commended isolation distance is based on equations that can be applied to transmitter frequencies. 17626.3 according to the transmitter manufacturer's which should be lower than the compliance...

  • Page 37: Recommended Safety Distances

    9.3 Recommended safety distances environment where radio frequency radiation disturbances are controlled. Depending radio frequency communication equipment (transmitter) and the continuous glucose monitoring system. 0.01 0.12 0.12 0.23 0.38 0.38 0.73 corresponding transmitter frequency column. Determine where P is the maximum manufacturer.
  • Page 38 Active medical devices are subject to special EMC precautions and must therefore be installed and used in accordance with these guidelines. the other devices comply with the emission requirements of the respective national standards.
  • Page 39 Glucose reading is Continue glucose monitoring Glucose reading is Continue glucose monitoring Permission to be activated. Activate the corresponding Ottai has not been activated permissions according to on the mobile phone. the instructions. APP crashed or freezes. Open the App store and upgrade the App version.
  • Page 40 installed due to improper Use of the Sensor or contact operation. 45°C (113°F)) and turn it on again. Another situation occurs Contact the customer...
  • Page 42 12. Information on Clinical Trials product was worn on the lateral margin of the biceps the EKF glucose detector was used as the gold standard and the safety of the product was evaluated during wearing. Types of Indicators Evaluation Indicators Clinical Trial Results 20/20% concurrence with 93.3%...
  • Page 43 higher than 90% for all time staging except for the late stage (day 14) where the 20/20% concordance rate was 86.8%. Security evaluation indicators was 0.065 ± 0.085. Product Ease of Use and the average of the total score ease of use of the product is good. Sensor Life failure rate of 11.6%.
  • Page 44 glucose reminder was set to 11.1 mmol/L or 200 mg/dL. includes the success rate and failure rate of high and low the number of times the continuous glucose monitoring the above period. 02) Low glucose detection success rate and failure rate (i.e. within 30 minutes before and after the continuous glucose monitoring system prompts a continuous low within 30 minutes before and after the continuous...
  • Page 45 30 minutes before and after the continuous glucose of EKF that does not detect high glucose within 30 minutes before and after the continuous glucose monitoring system prompts a high glucose event. Success and loss Success and loss Success and loss success rate and loss Failure rate (i.e.
  • Page 46 their own glucose conditions. subgroups with glucose <3.9mmol/L or 70mg/dL measurement points falling in the A+B area of the reading measured by the system.

  • Page 47: Appendix 1: Markers And Symbols

    Appendix 1: Markers and Symbols Do not throw in trash can Keep away from Direct Sunlight Manufacture Date Manufacturer Medical Device...
  • Page 48 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 hypoglycemia that are not easy to be detected by traditional cannot be easily detected by traditional monitoring methods. Device An integrated system consisting of components such as an Applicator and a Sensor.
  • Page 49 See product label. See product label.

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