Medical urination unit according to TU32.50.50-004-85403248-2023

Manufacturer: April Limited Liability Company

Legal address: 350042, Krasnodar Krai, Krasnodar, 40 Let Pobedy Street, 14/2, room 2

Place of production:
1) Hubei Handry Medical Appliance Co., Ltd.
(Hubei Hendry Medical Appliance Co., Ltd.)
Block 1, Building 2, Yinhu Science and Technology Park, Xiaohan Avenue, Xiaonan District, Xiaogan City, Hubei Province, China
(Unit 1 Building 2, Yinhu Science and Technology Park, Xiaohan Avenue, Xiaonan District, Xiaogan City, Hubei Province, China)
2) LLC "Aprel"
353254, Krasnodar Krai, Seversky Municipal District, Smolenskoye Rural Settlement, Stanitsa Smolenskaya, M. Gorkogo Street, 43 V

Phone: 8 861-212-32-82
E-mail: torgionline@gmail.com

SAFETY PRECAUTIONS

WARNING!
For external use only.
Use with caution if you have a history of skin allergies.
Do not apply directly to open or infected wounds, ulcers, or second-degree or greater burns.
If you have open wounds or ulcers in the stoma area, use with caution and only after consulting a specialist.
Avoid contact with the eyes and mucous membranes.
Close the lid tightly after each use to prevent the product from drying out or hardening.
Keep out of reach of children.

USED SYMBOLS

Name

Medical urination unit 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 urinate normally, including bedridden patients. The product is non-sterile and single-use.
It is not subject to sterilization, disinfection, maintenance, or repair.

EXECUTION OPTION

Medical foot urination device (NC: 156390), consisting of:
Medical foot urination device for adults (article number: MN755/1, MN759/1, MN755H/1, MN759H/1, MN755/2, MN759/2, MN755H/2, MN759H/2, MN755/1, MN759/1, MPR755H/1, MPR759H/1, MPR755/2, MPR759/2, MPR755H/2, MPR759H/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.;
Instructions for use No. WS-004-IU– 1 copy.
Accessories:
A strap for attaching a urine bag, article no. PKM1– no more than 200 pcs./pack.;
Medical bedside urinal (NK: 156370), consisting of:
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 90 cm long tube, 100 cm, 120 cm; volume of 1000 ml or 2000 ml; with or without a handle
– no more than 200 pcs/pack;
Instructions for use No. WS-0

APPEARANCE AND GENERAL DESCRIPTION OF THE DESIGN VARIANT

Chronic or acute urinary retention;
•Incontinence or urinary incontinence;
•Collection of a urine sample for testing;
•Measurement of residual urine volume and monitoring of urine output;
•Management of urine output in patients in a coma;
•Management of urine output 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;
•Postoperative rehabilitation 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 at the top of the bag to secure the urine collector. / Use the slots on the side surfaces of the urine collector to secure the urine collector 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 bag

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

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

h. Mass characteristics

i. Technical specifications

Structure

CONDITIONS OF TRANSPORTATION, STORAGE, AND OPERATION

– temperature: from 0 to +40 ºC;
– humidity: Not higher 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.
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: 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, the operation of production and public premises, and the organization and implementation of sanitary and anti-epidemic (preventive) measures