Express analyzers (glucometers) portable Accu-Chek Active. Express analyzers (glucometers) portable Accu-Chek Active Glucometer registration certificate

Instructions for use

Accu-Chek active glucometer / set / instructions for use

Compound

Equipment:

Accu-Chek Active glucometer with battery

10 Accu-Chek Active test strips

Accu-Chek Softclix skin lancing device

10 Accu-Chek Softclix lancets

User guide

Brief instructions

Warranty card

Description

Key Features:

No coding required

Large display

Large and convenient test strip

Specifications:

Blood drop volume: 1–2 µl

Memory: 500 results

Average results for 7, 14, 30 and 90 days

Markings for results before and after meals

Measuring reminders after meals

The most popular glucose meter in the world*. Now without coding.

The Accu-Chek Active glucometer is a global bestseller** in the self-monitoring market.

More than 20 million users in more than 100 countries around the world have already chosen the Accu-Chek Active system.*

Selling Features

Without a license

Special conditions

The system is suitable for measuring blood glucose levels obtained from alternative sites. The system cannot be used to make or exclude a diagnosis of diabetes. The system can only be used outside the patient's body. The meter is not approved for use by visually impaired people. The glucometer may only be used for its intended purpose.

Indications

The blood glucose monitoring system, consisting of a glucometer and test strips, is suitable for both self-monitoring and professional use. Diabetic patients can self-monitor their blood glucose levels using this system.

Healthcare professionals can monitor patients' blood glucose levels and use the system for emergency diagnosis if diabetes is suspected.

Mode of application

Dosage

The formation of a drop of blood will be helped by stroking the finger with light pressure in the direction of the fingertip.

Place a drop of blood in the middle of the green field. Remove your finger from the test strip.

Once the meter detects that blood has been applied, a beep will sound.

The measurement begins. A flashing hourglass icon means a measurement is in progress.

If you have not applied enough blood, after a few seconds you will hear an acoustic warning in the form of 3 beeps. Then you can apply another drop of blood.

After approximately 5 seconds the measurement is completed. The measurement result is displayed on the display and a sound signal sounds. At the same time, the glucometer stores this result.

You can mark the test result, set a test reminder, or turn off the meter.

For more detailed usage information, please refer to the user manual.

Unique registry entry number

Registration number of the medical device

FSZ 2007/00817

Date of state registration of the medical device

Name of medical product

Express analyzer (glucometer) portable for determining blood sugar levels "Accu-Chek Active" with accessories
Accessories: 1. Accu-Chek Softclix Lancing Device. 2. Accu-Chek Softclix lancets, 10 pcs. (Accu-Chek Softclix Lancets, 10 pcs). 3. Accu-Chek Active test strips, 10 pcs. (Accu-Chek Active Test Strips, 10 pcs) - no more than 5 packs. 4. Accu-Chek Active test strips, 50 pcs. (Accu-Chek Active Test Strips, 50 pcs) - no more than 5 packs. 5. Test strips "Accu-Chek Active", 2x50 (100) pcs. (Accu-Chek Active Test Strips, 2x50 (100) pcs) - no more than 5 packs. 6. Carry Case.

Name of the organization - applicant of the medical device

LLC "Roche Diabetes Care Rus"

Location of the applicant organization for the medical device

115114, Russia, Moscow, st. Letnikovskaya, 2, building 2, Vivaldi Plaza Business Center

Legal address of the applicant organization for the medical device

107031, Russia, Moscow, Trubnaya Square, 2, room. I, room 42B

Name of the medical device manufacturer or medical device manufacturer

Roche Diabetes Care GmbH

Location of the organization-manufacturer of the medical device or organization-manufacturer of the medical device

Legal address of the organization-manufacturer of the medical device or organization-manufacturer of the medical device

Germany, Far Abroad, Roche Diabetes Care GmbH, Sandhofer Strasse 116, 68305 Mannheim, Germany

Code of the All-Russian Product Classifier for a medical device

Class of potential risk of using a medical device in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of the Russian Federation

2a (medium risk medical devices)

Type of medical device in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of the Russian Federation

Address of the place of production or manufacture of the medical device

1. Roche Diagnostics GmbH, Sandhofer Strasse 116, 68305, Mannheim, Germany. 2. Roche Diabetes Care GmbH, Sandhofer Strasse 116, 68305, Mannheim, Germany. 3. Asahi Polyslider Company, Limited, Okayama Kuse Plant, 860-2 Misaki, Maniwa, Okayama, Japan. 4. Balda Medical GmbH & Co. KG, Bergkirchener Straß,e 228, 32549 Bad Oeynhausen, Germany. 5. Gerresheimer Regensburg GmbH, Hirtenstrasse 50, 92536 Pfreimd, Germany. 6. HTL-Strefa S.A., ul. Adamó,wek 7, 95-035 Ozorkó,w, Poland. 7. Sanmina Ireland UC, Rathealy Road, Fermoy, County Cork, Ireland. 8. Sanmina (Shenzhen) Ltd., 1 Nan Ling Road, Xin Er Industrial District, Sha Jing, Bao An, Shenzhen 518125, China.

Express analyzers (glucometers) portable Accu-Chek Active (hereinafter referred to as glucometers) are designed to measure the glucose (sugar) content in whole capillary blood using specially designed test strips.

Description

The principle of operation of glucometers is based on the photometric determination of changes in the reflectance of the analytical zone of the test strip. The code plate included in the package of test strips contains the necessary information about this lot of test strips. When a drop of blood is applied to the test field of the test strip, the reflectance on the analytical zone changes.

Using a built-in optical-electronic system, the degree of this change is measured, which is proportional to the glucose (sugar) content in the patient's blood. The measurement result is displayed on the built-in display screen in mmol/l and is automatically stored in the glucometer's memory. Glucometers are designed as portable devices, with the ability to transfer measurement results via an infrared port to a PC.

A general view of the glucometer is shown in Figure 1.

Figure 1 - Express analyzer (glucometer) portable Accu-Chek Active

Glucose meters use built-in software that is installed directly into the meters' ROM by the manufacturer.

^ Protective film with a sealing effect Model

The software is designed to control the system, the controller of the internal actuators of measuring devices and its settings, as well as to ensure the functioning of the interface, processing information obtained using measuring devices during the measurement process.

Identification data (signs) of the metrologically significant part of the glucometer software are listed in Table 1.

Table 1

Software protection from unintentional and intentional changes corresponds to level “A” according to MI 3286-2010.

Specifications

Table 2 shows the technical and metrological characteristics of the glucometer.

table 2

Type approval mark

The type approval mark is printed on the second sheet of the Operation Manual.

Completeness

I. Express analyzer (glucometer) portable Accu-Chek Active

II. Accessories:

1. Accu-Chek Softclix finger lancing device

2. Lancets "Accu-Chek Softclix" No. 10 (Accu-Chek Softclix Lancets No. 10)

3. Test strips "Accu-Chek Active" No. 10 (Accu-Chek Active 10 Strips)

4. Carry Case

5.Operation manual

Verification

carried out according to document MI 3138-2008 “Recommendation of GSOEI Portable glucometers. Verification methodology."

Verification means are standard glucose samples with a concentration of 1.7 - 22.2 mmol/l (30400 mg/dl).

Information about measurement methods

Operating manual for the portable express analyzer (glucometer) Accu-Chek Active

Regulatory documents establishing requirements for portable express analyzers (glucometers) Accu-Chek Active

1. MI 3138-2008 “Portable glucometers. Verification method"

2. ISO standard 15197-2003. In vitro diagnostic systems. Requirements for monitoring systems for monitoring blood glucose concentrations for self-monitoring in the treatment of diabetes mellitus.

3. GOST R 50444-92. Medical devices, apparatus and equipment. General technical conditions.

Carrying out activities in the field of healthcare.