Name

Absorbent disposable diapers according to the 32.50.50-006-85403248-2024

EXECUTION OPTION

1. Disposable diapers "Normal"
composition:
- Disposable diapers "Normal": three-layer, size range: 60×40 cm; 60×60 cm; 60×90 cm; 90×180 cm – 10 pcs./pack., 30 pcs./pack.;
- Instruction for use No. 1 – 1 copy.
2. Disposable diapers "Extra"
composition:
- Disposable Extra diapers: three-layer, with absorbent, size range: 60×40 cm; 60×60 cm; 60×90 cm – 10 pcs./pack., 30 pcs./pack.;
- Instruction for use No. 1 – 1 copy.
3. Disposable Extra+ diapers
composition:
- Extra+ disposable diapers: three-layer, with absorbent, with Velcro, size range: 60×40 cm; 60×60 cm; 60×90 cm – 10 pcs./pack., 30 pcs./pack.;
- Instruction for use No. 1 – 1 copy.

Technical specifications

Structure

There are no drugs or materials of animal or human origin in the medical device.

Purpose

For use in the care of bedridden, post-operative patients, people with limited mobility, during medical examinations, manipulations, and procedures in medical facilities, social institutions, at home, during transportation, and as an additional protection when using diapers in the care of patients with urinary and fecal incontinence.
The product is non-sterile and single-use.
It is not subject to sterilization, disinfection, maintenance, or repair.

Classification

Class depending on the potential risk of use – 1, according to the nomenclature classification of medical devices (Order of the Ministry of Health of the Russian Federation dated 06.06.2012 No. 4n), a non-invasive medical device according to the classification of GOST 31508.
Type of medical device: 320550 Absorbent diaper

APPEARANCE AND GENERAL DESCRIPTION OF THE DESIGN VARIANT

Diapers are absorbent linen, structurally consisting of several layers (starting from the layer in contact with the user): the upper covering (covering), absorbent, lower protective (protective). The product may be equipped with Velcro.

INDICATIONS FOR USING THE IMPLEMENTATION OPTION

incontinence of urine and feces;
partial or complete immobility.;

Contraindications

Individual intolerance to materials.

SIDE EFFECTS

When used, it may cause skin redness, rash, peeling, itching, and burning.

SCOPE OF APPLICATION

In medical and social institutions, at home, and during transportation.

POTENTIAL CONSUMER

Patients, patient relatives, care specialists, and medical professionals.

METHOD OF APPLICATION:

1. Open the package and remove the product.
2. Unfold the diaper with the absorbent surface facing up, and place it where needed.
3. Change the diaper as needed.
4. Here is the recommended procedure for changing the diaper:
5. Gently move the patient to one side to expose the dirty diaper. Support their back with your hand.
6. Carefully remove the used diaper.
7. Clean the patient's skin with wet wipes to remove any remaining dirt. Pat the skin dry.
8. Place a new, clean diaper under the patient. Move the patient back, carefully placing them on the new diaper.
9. Make sure the diaper is flat and without wrinkles or lumps under the patient.
10. Wash your hands and put on new gloves.
11. Dispose of the used diaper and gloves properly.
12. It is important to be as gentle as possible to avoid causing discomfort or pain to the bedridden patient during the procedure. 13. If necessary, use an assistant.

DISPOSAL OF A MEDICAL PRODUCT

At home:

After use, dispose of it with solid household waste.
In medical and preventive institutions
Unused products and packaging are disposed of in accordance with local regulations as Class A waste.
When using medical products in infectious disease departments, used products are disposed of in accordance with local regulations as Class B waste.

Expiration date

Product shelf life: 4 years from the date of manufacture indicated on the packaging.
Do not use the product after the expiration date.

MANUFACTURER'S GUARANTEES

The manufacturer guarantees that the product meets the declared characteristics if the consumer follows the operating, transportation, and storage conditions.
The product has a warranty period of 4 years from the date of manufacture indicated on the packaging.

INFORMATION ABOUT COMPLAINTS

Claims are made in accordance with the established procedure at the manufacturer's address
APRIL LLC, Russia