What can I do if I have irritated skin caused by Glunovo sensor adhesive?

If your have allergy reaction to your current Glunovo sensor, such as irritated skin, please consult you local healthcare professionals as soon as possible and stop using Glunovo CGM.

The adhesive tapes used by Infinovo Medical have passed relevant safety and biocompatibility tests by certified laboratories and gained the ROHS certification.

If you allergy to silicone oil or acrylic acid, we do not recommend to use the Glunovo CGM.

If you have sensitive skin, we recommend you consult healthcare professionls before using the product. For detailed step-by-step instructions please refer to User Guides.

o   If you upload the data in the APP, you can export the data after the GN-I monitoring ends, stop the probe and remove the sensor

o   Tab on [Stop Sensor], [Stop Sensor] on the main interface will change to [Start Sensor], and display "Sensor has stopped". (After stopping the sensor, readings will no longer be received)

o   Make sure the transmitter is still fixed in the sensor base

o   Pull up the edge of the sticker that fixes the sensor on the skin, and slowly tear it off from the skin

o   Place the base with the launcher on a flat surface, use the two serrations of the positioning plate to snap into the buckles on both sides of the base, press down, and the launcher will pop out automatically. You can also use your fingers to open the clips on both sides of the sensor base to remove the transmitter from the base, or use the positioning plate to remove the transmitter

o   Note: Do not remove the transmitter while the sensor base is attached to the skin. Remove the transmitter from the base after the sensor base is peeled off the body

The Glunovo i3 CGM features a small sensor that measures glucose levels just underneath the skin and a transmitter that is fastened on top of the sensor and sends data wirelessly to the compatible smart device. Out-of-range glucose alerts may be sent to the user’s smart device.

The Glunovo i3 CGM measures and sends data to a compatible device once every 3 minutes.

The Glunovo i3 CGM features Bluetooth wireless technology in the transmitter that enables direct transmission of CGM data to a compatible smart device. For a list of compatible smart devices, please refer to the Glunovo i3 CGM User Manual.

The Glunovo i3 CGM suitable for non-pregnant adult diabetics (age 18 or older) without serious complications.

Glunovo i3 CGM readings are taken from interstitial fluid, and not from blood, like fingersticks. Interstitial fluid is the fluid that surrounds the cells of the tissue below the skin, and usually, glucose moves from blood vessels and capillaries first and then into the interstitial fluid. It’s helpful to think about it like a rollercoaster where the front car is the blood glucose (BG) and the car in the back is the Glunovo i3 CGM reading: When on the rise, the BG value is greater than the Glunovo i3 CGM reading that follows behind it. But when moving down the tracks, the BG in front is now less than the Glunovo i3 CGM reading.

Not currently supported. If you want to make treatment decisions refer to meter's reading.

Sensor and Transmitter humidity and temperature control notice

Sensor

1.     Keep in a sterile package until ready for use

2.     CGM products need to be stored at a temperature between 2° C (36° F) and 25° C (77° F). Storing sensors correctly to prevent system failures. If the temperature is over 40° C (104° F) will lead the significant inaccurate readings

3.     You can store your sensors at room temperature or in your refrigerator. Store sensors in a cool, dry place. Don’t store it in a parked car on a hot day or in the freezer

4.     Storage and Transport Conditions:

     Temperature: 2° C (36° F) ~25° C (77° F)

     Humidity： RH 15% ~85%

Transmitter:

1.     Operational Conditions：

       Ambient temperature is 10° C (50° F) ~40° C (104° F)

2.     Storage and Transport Conditions：

      Temperature: 0℃ (32° F) ~45℃ (113° F)

      Humidity: RH10% ~95%

      Operating Altitude: 70kPa ~106kPa

Caution:

1.     When the session ends, please use a releaser to un-embed the transmitter from the sensor, any other items might damage the housing of the transmitter.

2.     Avoid contact with acidic substances or other corrosive solvents with metal contacts, which may lead to poor contact caused by oxidation and corrosion of metal contacts.

3.     The transmitter needs to avoid sharp objects from scratching, which may harm the waterproof seal.

4.     When the device is in use, the wearing location should avoid external pressure, which may cause inaccurate readings or block communication with your smartphone.

Reminder：

Before using the device, the warehousing, logistics, and storage environment before any time/place should be strictly controlled according to temperature and humidity and follow the product instructions. If you don't follow the instructions, you may have severe hypoglycemia or hyperglycemia events or cause malfunction of the product. Proper storage of CGM helps prevent system failures.

Appendix:

l  IP27: Protection Against Insertion of Large Objects and Immersion in Water

l  Keep Away from Heat

l  Temperature Limitation

l  Keep Dry

l  MR Unsafe

l  Non-Ionizing Radiation

l  Refer to Instruction Manual/Booklet

l  Do not use it if the package is damaged

l  Do not reuse

*Waterproof

The waterproof grade of the device is IPX7, the reference standard is IEC 60529-2013:

Protected against the effects of temporary immersion in clean water.

Quote:

“Ingress of water in quantities causing harmful effects shall not be possible when the enclosure is temporarily immersed in water under standardized conditions of pressure and time.

14.2.7 Test for second characteristic numeral 7: temporary immersion between 0,15 m and 1 m.

The test is made by completely immersing the enclosure in water in its service position as specified by the manufacturer so that the following conditions are satisfied:

a) the lowest point of enclosures with a height of less than 850 mm is located 1 000 mm below the surface of the water

b) the highest point of enclosures with a height equal to or greater than 850 mm is located 150 mm below the surface of the water

c) the duration of the test is 30 min

d) the water temperature does not differ from that of the equipment by more than 5 K

However, a modified requirement may be specified in the relevant product standard if the tests are to be made when the equipment is energized and/or its parts in motion”

-END-

The non-woven tape of the sensor base can be attached with medical tape to strengthen the fixation of the sensor base

No arm indications now, no relevant data

The Glunovo CGM product is based on the principle of electrochemical reaction. The probe generates an electrical signal by chemical reaction with glucose in the subcutaneous interstitial fluid of the abdomen. The transmitter analyzes and calculates the electrical signal, and the calculation result is transmitted to the mobile application software through the Bluetooth of the transmitter.

Glunovo App is compatible with the system of Android 9 and above. 

Android is compatible with:

Honor: HRY-AL00a

Huawei: Mate 20, Mate 30, P30 pro, nova 6

Red MI: K30 pro, Redmi 10 pro, Redmi 9A

Samsung: Galaxy A70, A52, S8

XIAOMI: 9, 10 pro

Glunovo App is compatible with the iOS system of iOS 14 and above.

iOS is compatible with:

iPhone 7

iPhone 8, iPhone 8 Plus

iPhone SE, iPhone X, iPhone Xs Max

iPhone 11, iPhone 11 Pro, iPhone 11 Pro Max

iPhone 12, iPhone 12 Pro, iPhone 12 Pro Max

iPhone 13, iPhone 13 Pro, iPhone 13 Pro Max

Glunovo E2 App is compatible with the system of Android 9 and above. 

Android is compatible with:

• Huawei: Mate 20
  

• Red MI: K30 pro, Redmi 10 A

• Samsung: Galaxy A53, Galaxy S8, Galaxy S21 FE, Galaxy S21(5G), Galaxy S22 Ultra 5G, Galaxy Z Flip 4

• XIAOMI: 12S pro

Glunovo E2 App is compatible with the iOS system of iOS 14 and above.

iOS is compatible with:

• iPhone X
  

• iPhone 11
  

• iPhone SE
  

• iPhone 14
  

What is status code?

To improve trouble-shooting efficiency, we add status code to Glunovo App's home screen

Please refer to table below as explanation of status code:

Link:https://www.infinovo.com/en/shows/52/61.html

You can download Glunovo APP, GN-Share, and GN-Carer from Apple Store/Google Play. 

Web Portal：http://glunovoshare.com/

You can download Glunovo APP, GN-Share, and GN-Carer from Apple Store/Google Play. 

Web Portal：http://glunovoshare.com/