Medical urinary catheter according to TU 32.50.50-004-85403248-2023

SAFETY PRECAUTIONS

USED SYMBOLS

Article number for urinators:

where:

Name

Medical urinary catheter according to TU 32.50.50-004-85403248-2023

Purpose

The medical urine collector is used to collect urine during catheterization or for continuous urine collection in people who temporarily or permanently cannot perform normal urination, including bedridden patients. The product is non-sterile and single-use.

MODELS:

1. Medical foot urine collector (NC: 156390), consisting of:

1.1. Medical foot urination device for adults (article number: MN755/1, MN759/1, MN755N/1, MN759N/1, MN755/2, MN759/2, MN755N/2, MN759N/2, MN755/1, MN759N/1, MN755N/1, MN759N/1, MN755/2, MPR759/2, MPR755N/2, MPR759N/2): with a tube length of 50 cm, 90 cm; volume of 750 ml; with or without a non–woven backing - no more than 200 pcs./pack.;

1.2. Instructions for use No. WS-004-IU – 1 copy

Accessories:

1.3. Strap for attaching the urine collection bag, item number RKM1 – no more than 200 pieces per package;

2. Bedside medical urine collector (NC: 156370), consisting of:

2.1. Medical bedside urinal for adults (article number: MP209/1, MP201/1, MP202/1, MP209/2, MP201/2, MP202/2, MPR209/1, MPR01/1, MPR202/1, MPR209/2, MPR201/2, MPR202/2, MP101/1, MP101/2, MP102/1, MP102/2, MP109/1, MP109/2): with a tube length of 90 cm, 100 cm, 120 cm; volume of 1000 ml or 2000 ml; with or without a handle – no more than 200 pcs./pack.;

2.2. Instructions for use No. WS-004-IU – 1 copy

APPEARANCE AND GENERAL DESCRIPTION

A product consisting of a urine collection bag with a measuring scale, a tube with a conical connector, a urine backflow prevention valve, and a drain valve.
It has a T-shaped drain valve.
It may have a soft non-woven backing.
It has a mounting system.
The leg urine collector should have slots on the side surfaces of the urine collector.
The bedside urine collector should have holes or a handle for mounting.
The foot-mounted urine collector can be equipped with a belt for attaching the urine collector bag

Not subject to sterilization, disinfection, maintenance, or repair.

INDICATIONS FOR USE

Chronic or acute urinary retention;

• Incontinence or urinary incontinence;

• Collecting a urine sample for analysis;

• Performing a residual urine volume measurement and monitoring diuresis;

• Urinary excretion in patients in a coma;

• Urinary excretion in patients who are unable to empty their bladders on their own; patients who are under the influence of anesthetics or sedatives during the preoperative or rehabilitation period;

• Rehabilitation process for post-operative restoration of the genitourinary system.

The product is used under the prescription of a doctor. Depending on the indications, it is administered by a medical professional or by the patient themselves.

Contraindications

Individual intolerance to materials.

SIDE EFFECTS

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

SCOPE OF APPLICATION

Departments of urology, internal medicine, surgery, oncology, obstetrics and gynecology, and therapy; rehabilitation; at home and in medical and preventive institutions.

POTENTIAL CONSUMER

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

METHOD OF APPLICATION:

1. Open the package and remove the product.
2. In the urine collector with a removable connector, shorten the discharge tube to the required length.
3. If necessary, connect the adapter to the discharge tube and connect it to the catheter.
4. Make sure that the catheter and the tube are not twisted or bent, as this may prevent urine from flowing properly.
5. Use the holes and the handle on the top of the bag to secure the urine collector. / Use the slots on the side surfaces of the urinary catheter to secure the catheter using the straps (if available).

Technical specifications

a. Geometric dimensions of urinary bags

b. Geometric dimensions of the discharge tube

c. Geometric dimensions of the belt for attaching the urine collection bag

d. Geometric dimensions of the adapter for attaching the PKK1 catheter

e. Geometric dimensions of the adapter for attaching the PKK2 catheter

h. Mass characteristics

PRODUCT MATERIALS

Type and duration of contact of a medical device according to GOST ISO 10993-1: Short-term contact medical devices that only contact the surface of intact skin.

CONDITIONS OF TRANSPORTATION, STORAGE, AND OPERATION

– temperature: from 0 to +40 ºC;
– humidity: No more than 80%.
The product should be protected from direct sunlight, and should not be exposed to heat or freezing. Store in a dry, clean place.
Keep out of reach of children.

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 in accordance with SanPiN 2.1.3684-21.
When using medical products in infectious disease departments, used products are disposed of in accordance with local regulations as Class B waste in accordance with SanPiN 2.1.3684-21.

Expiration date

Product shelf life: 5 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 conditions of use, transportation, and storage.
The product is guaranteed to remain sterile for 5 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 ISO 10993-1 Medical devices. Assessment of the biological effect of medical devices. Part 1. Assessment and research in the risk management process

SanPiN 2.1.3684-21 Sanitary and epidemiological requirements for the maintenance of urban and rural settlements, water bodies, drinking water and drinking water supply, atmospheric air, soils, residential premises, operation of production and public premises, organization and implementation of sanitary and anti-epidemic (preventive) measures