iCheck.PRO Test Strips No. 50

Intended Use and Scope of Application
The test strips are intended for use with the iCheck.PRO and iCheck.RU rapid capillary blood glucose meters according to TS 21.20.23-002-18023326-2018, as well as with the iCheck glucose meter, for in vitro diagnostics — quantitative determination of glucose in a clinical blood sample (fresh capillary whole blood) obtained from the finger, palm, forearm, or upper arm. The product serves as an adjunct tool for monitoring the effectiveness of glycemic control, both by healthcare professionals in clinical settings and for self-testing at home. The device is not intended for the diagnosis of diabetes mellitus or for testing neonatal cord blood samples.

Indications for Use of the Medical Device
Determination and monitoring of glucose levels in capillary blood, including in individuals with diabetes mellitus, as an adjunct tool for monitoring the effectiveness of glycemic control.

Type of Analyzed Sample
The test strips are intended for use only with fresh capillary whole blood; use with plasma or serum is not supported.

Operating Principle
The enzyme contained in the test strip converts glucose in the blood sample to gluconolactone. The result of this reaction is a harmless direct-current electrical signal in the rapid glucose meter, which is used to calculate the blood glucose concentration. Sample characteristics and measurement environment parameters are monitored using both direct-current and alternating-current signals.

Product Specifications
The test strip is a small, dense rectangle with rounded edges and consists of three plastic (PET) layers of varying thickness. Between these layers, a thin coating of silver and conductive carbon ink, as well as a biochemical material, is applied. The plastic layers feature an adhesive coating (acrylic adhesive). Longitudinal black lines are printed on the surface of the test strip to indicate the edge that should be inserted into the slot of the rapid analyzer. On the side of the test strip, there is a rectangular area for applying a drop of blood.
The biochemical material consists of: Glucose oxidase enzyme — 11%, Phosphate buffer — 34%, Potassium ferricyanide — 23%, Stabilizer — 3%, Inactive ingredients — 29%
Test strips are packaged in a hermetically sealable vial, containing either 25 or 50 strips.
The overall dimensions and weight of the test strip shall correspond to 37 × 10 × 0.6 mm and 0.238 mg, with permissible dimensional deviations of no more than ±1%.

Important
iCheck.RU test strips are intended solely for in vitro diagnostics and are not used for direct impact on the human body. Measurement results do not replace medical consultation and should be interpreted taking into account the clinical situation and specialist recommendations.
Advantages of the iCheck.PRO System

• Ease of use: Test strips do not require the user to code the glucose meter before using a new pack.
• Small sample volume: Only 0.6 µL of blood is required for analysis.
• Speed: Rapid result delivery — testing time is up to 9 seconds.
• Compatibility: Compatible with multiple devices, such as the iCheck.PRO and iCheck.RU rapid capillary blood glucose meters according to TS 21.20.23-002-18023326-2018, as well as with the iCheck glucose meter.

- The capillary test strip automatically draws in the required blood volume in approximately 1 second.

• “Sip-in” technology: The test strip automatically draws in the required blood volume when the drop contacts the edge of the reaction zone (capillary diffusion).
• Protection and safety: A special protective layer allows the user to touch any part of the test strip without compromising the functionality of the reaction zone.
• Fill control: A control field on the test strip changes color to indicate whether sufficient blood has been applied for an accurate measurement.
• Accuracy: According to clinical and laboratory studies, the diagnostic accuracy of the assay is 94%, meeting the requirements for professional-grade equipment.
• Versatility: Suitable for use both in hospital settings and for home self-monitoring.

Technical Specifications

• Measurement method: Electrochemical
• Calibration: Plasma-referenced
• Measurement range: 1.3 to 41.7 mmol/L
• Measurement time: 9 seconds
• Blood sample volume: 0.6 µL
• Test strips: Packaged in vials of 25 or 50 strips

Package Contents — Configuration Option 2

• Test strips — 50 pcs
• Vials for test strips — 2 pcs
• User manual — 1 pc

Storage and Handling

• Shelf life of test strips: 24 months from the date of manufacture
• Period of use after opening: 120 days from the first opening of the vial
• Storage conditions: At temperatures from +2°C to +30°C and relative humidity below 80%

Care
No special care measures are required for the test strips, other than complying with storage conditions and handling the packaging with care.

Warning!
The device is intended for in vitro diagnostics. Before use, it is recommended to consult with hotline specialists at 8 (800) 555-49-00 and with your treating physician, as well as to carefully read the instructions for use.

Precautions and Disposal Information

1. Carefully read the instructions before using the device.
2. Perform testing in strict accordance with every step of the instructions, without deviations.
3. All components of the device are non-toxic.
4. Keep the device out of reach of children.

When using the device, comply with the following requirements:

• Do not use the device if the packaging integrity is compromised.
• Do not use the device after its expiration date.
• The device is for single use only: each test strip is intended for testing one biological sample. Reuse is not permitted.
• Before testing, thoroughly wash your hands with warm water and soap.
• Disinfect the puncture site with an appropriate antiseptic.
• Device components consist of small parts that may be attractive to young children. Ensure that children do not inhale, swallow, or play with the device. Seek medical attention if necessary.
• Use the test strip within three minutes after removal from the vial; otherwise, it may absorb moisture and yield an inaccurate result.
• Do not use test strips that are wet, scratched, or damaged.
• Do not smear the blood drop across the reaction zone of the test strip.
• Self-obtained results are for informational purposes only. Do not change your diabetes management program based on the results without prior consultation with your physician.
• If your blood glucose readings are too high or too low (the display shows [HI] or [Lo]), repeat the measurement with a new test strip. If you again obtain a [HI] or [Lo] result, contact your physician immediately.
• If you have doubts about the accuracy of the results, repeat the measurement with a new test strip. If the results remain the same, contact your physician immediately.
• If sugar gets on your fingers, the results may be inaccurate.

For safe use, follow these recommendations:

1. Do not wash or spill liquids on the test strips.
2. Do not leave test strips in high-humidity environments such as bathrooms, kitchens, etc.
3. Do not allow dust to accumulate.
4. For safety reasons, test strips are intended for individual use only.