Name

Disposable absorbent diapers according to TU 32.50.50-006-85403248-2024

USED SYMBOLS

Name

Disposable absorbent diapers according to TU 32.50.50-006-85403248-2024

MODELS

1. Disposable absorbent diapers "Normal", consisting of:
1.1. Disposable absorbent diapers "Normal": three-layer diapers, size range: 60×40 cm; 60×60 cm; 60×90 cm – 10 pcs./pack., 30 pcs./pack.;
1.2. Instructions for use (access via the QR code on the consumer packaging label)
2. Disposable Extra diapers, consisting of:
2.1. Disposable Extra diapers: three-layer diapers, available in sizes: 60×40 cm; 60×60 cm; 60×90 cm – 10 pieces per pack, 30 pieces per pack;
2.2. Instructions for use (accessible via the QR code on the consumer packaging label)
3. Disposable Extra+ diapers, consisting of:
3.1. Disposable Extra+ diapers: three-layer diapers with Velcro straps, available in the following sizes: 60×40 cm, 60×60 cm, and 60×90 cm – 10 pieces per pack, 30 pieces per pack;
3.2. Instructions for use (accessible via the QR code on the consumer packaging label)

Technical specifications

Diapers are absorbent linen, structurally consisting of three 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. The scheme of the layers:
 There are no medicines and materials of animal or human origin in the medical device.

Diagram 1 – Layer arrangement diagram, where:

1) Velcro (if available);
2) protective layer;
3) absorbent layer;
4) covering layer.

The difference between models

PRODUCT MATERIALS

Non-woven fabric, dissolved cellulose, base paper, pet film, silicone paper (for the Extra+ disposable absorbent diaper model), thermoforming glue
 There are no drugs or materials of animal or human origin in the medical device.

Purpose

For use in the care of bedridden, postoperative patients, people with limited mobility, during medical examinations, manipulations, and procedures in medical and preventive institutions, social institutions, at home, during transportation, and as an additional protection when using diapers in the care of patients suffering from 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

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 USE

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.
It is important to be as gentle as possible to avoid causing discomfort or pain to the patient during the procedure. 13. If necessary, use an assistant.

CONDITIONS OF TRANSPORTATION, STORAGE, AND OPERATION

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 specifications 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

LIST OF STANDARDS

GOST 31508-2012 Medical products. Classification according to the potential risk of use. General requirements
GOST R 57762-2021 Absorbent underwear. General technical conditions