LLC “Enterprise “Vladeks”
“Vladeks” – is the modern scientific and production enterprise, specialized in the field of development, uptake and commercialization of modern
- different high functional dressing products
- biologically active dressing materials and means
- additional attendant accessories and means
All the production is developed in association with the medical specialists of the A.V. Vishnevsky Institute of Surgery and the RF Ministry of Defense and registered in the Ministry of Public Health and Social Development. The production is certified and corresponds to the world analogue level. The developed production and its manufacturing technology hold RF patent.
LLC “Enterprise “Vladeks” is the shining example of a successful, stable developing Russian company. Within 18 years the company took all the best from the world experience and created a principally new approach to the question of the development of the ecologically harmless, mechanically fastened linen piercing and needle-punched nonwoven fabrics and combined dressing materials based on them.
The enterprise successfully combines manufacturing and scientific activities. For many years “Vladeks” is the research and development performer in different governmental programs. In 1996 the development of the sterile first-aid pack in three hardware versions became the result of the work.
According to the composition of the bolsters and their functional features the following first-aid pack brands exist:
- IDP AB-3 (noninvasive, sorption, moistureproof)
- IDP AAB-4 (noninvasive, antimicrobial, sorption, moistureproof)
- IDP AYB-4 (noninvasive, carbonaceous, moistureproof, providing the selective sorption of the wound microflora)
According to the results of the clinical tests held by the Military Medical Academy (St.Petersburg), the main military clinical hospital n.a. N.N. Burdenko and some other hospitals the recommendations to the serial production of the sterile first-aid packs for the medicine needs , RF armed forces medical service, Ministry of Internal affairs and the Ministry of Emergency Situations were given. The sterile first-aid packs consist of the noninvasive, carbonaceous, moistureproof materials (IDP AYB-4) are considered the most advanced.
In 2005 in the frames of the design and experimental work LLC “Enterprise “Vladeks” in association with the federal state unitary enterprise “State science research Institute of organic chemistry & technology” developed the integrated individual package for the decontamination.
Since 2007 the enterprise produces the following additional devices:
- Decontamination glove TOR 8397-009-17777359-2007
- Formulae-taking drape TOR 8397-010-17777359-2007
In 2007 “Vladeks” in association with the Institute of Chemistry of the Russian Academy of Sciences developed the structure of the combined dressing products on the linen fiber base. After the clinical tests of the noninvasive, antimicrobial and sorption “Biolen” fabrics and the eight hardware bandage versions of the same material the Federal Supervisory Agency for Health Care and Social Development gave the permission to the serial production of the following dressing products:
- “Biolen-X” on the basis of the linen fiber with chlorhexidine
- “Biolen-ÁÌ” on the basis of the antimicrobial linen fiber with biopag and copper salt
- “Biolen-Ì” on the basis of the antimicrobial linen fiber with miramistine
- “Biolen-Ä” on the basis of the antimicrobial linen fiber with dioksidin
- “Biolen-Ï” on the basis of the antimicrobial linen fiber with piviarghole
- “Biolen-Á” on the basis of the antimicrobial linen fiber with biopag
- “Biolen-ÁÏ” on the basis of the antimicrobial linen fiber with biopag and piviarghole
- “Biolen-T” on the basis of the antimicrobial linen fiber with tephlex
At the present time the series of the bioactive dressing products with the antimicrobial action is ready to be implemented. The dressing products are the following:
- nonwoven noninvasive combined fabrics in two brands for the nanostructural silver cover application (TOR 8397-011-17777359-2008)
- bioactive antiseptic first-aid packs on the base of the nonwoven noninvasive combined fabrics for the nanostructural silver cover application (sterile noninvasive, antimicrobial first-aid packs “AB-3 - NANO”, TOR 9393-007-17777359-2009).
All the production manufactured by the LLC “Enterprise “Vladeks” also developed in the frames of the scientific activity and design and experimental works.
In 2007 the company authorities took a strategically decision to implement the quality management system which coincides with the world standard demands ISO 9001:2000 and on the December 25,2007 the certification of conformity was gained.
The steady demand on the issued products is the best witness of the successful development of the LLC “Enterprise “Vladeks” and its leading positions on the market. Today this is a wide spectrum of the modern combined dressing products and means which are constantly widen in accordance with the technological innovations. Modern approach to work, high quality of the products achieves the authority before the leading medical institutions of Russia.
Address: 142211, Moscow region, Serpukhov, Soltsa Street, 1
Telephone Fax: (499) 270-62-01
Moscow, Varshavskoe highway, 132
Juridical address: 117534, Moscow, Chertanovskaya, 54 -1
Mail address: 142211, Moscow region, Serpukhov, Soltsa Street, 1
Official web-site: http://www.vladeks.com
E-mail: vladeks.org@mail.ru
“VLADEKS +”
Specification
(information for the consumers)
on the medical use
First-aid individual dressing package (IDP)
sterile
Description.
First-aid individual dressing packages (IDP AB-3) consist of one bolster (immovable) or two bolsters (immovable and movable) and fixing gauze or elastic bandage.
IDP AB-3 bolsters have three layers:
- Noninvasive, providing the minimal sticking to the wound on the basis of the knitted net
- Sorption (absorbent) on the basis of the bleached cotton and viscose fibers
- Defensive (moistureproof) on the basis of the nonwoven polypropylene fabric
IDP AB-3 is packed in the outer cover –the multi-layer combined material: lavsan-foil- polyethylene and the inner cover – polyethylene.
IDP AB-3 makes the conditions necessary for the primal trauma complication precautions:
- Do not damage the subiculum when taking off
- Do not cause the pain syndrome to the patient
- Prevent the outer wound contamination
- Have no contraindications
Characteristic
First-aid individual dressing packages are used for the first medical aid, self care and mutual help in case of wounds, burns on the first stages and in cases of the home, production and road-transport traumas for wounds, burns, bed sores, trophic ulcer and other damages.
Indications
First-aid individual dressing packages may be used as the primary bandage in hospitals, polyclinics, medical institutions, field conditions and household.
1. tear off the outer cover where cut
2. take off the inner cover
3. unfold the bolsters, put to the wound with the side marked with white thread, make a bandage and fasten.
Contraindications
Have no contraindications
First-aid individual dressing packages are supplied in the multi-layer combined material pack and have the following shape: length – not more 18,5 cm, width – not more 10,5 cm, thickness – not more 5,5, cm.
Shellfire and recommendations on storage
Keep in dry cold places within the temperature -50 C to +42 C, with the relative humidity not more than 80%.
Shelf life is 5 years since the sterilization date.
TOR 9393-001-17777359-98
Registration certificate ¹ PS 01011374/2283-05, date 22.09.05
Producer: LLC “Enterprise “Vladeks”, Moscow
(the coat of arms) (19) RU (11) 2164150 (13) Ñ2
(51) 7 A 61 L 15/00, A 61 À 13/00
Russian patent and Trade marks Agency
(12) The invention description
To the RF patent
(21) 97111387/14 (22)09.07.1997
(24) 09.07.1997
(43) 10.06.1999, bull ¹16
(46) 20.03.2001, bull ¹8
(72) Adamjn A.A., Brusov P.G., Dobish S.V., Zhiljev E.G., Matukhina U.I., Stoicheva L.A., Tolochkova O.N., Fedorov V.D., Shevereva L. G.
(71) (73) LLC “Enterprise “Vladeks”, A.V. Vishnevsky Institute of Surgery, Russia Academy of Medical Sciences
(56) SU 1635984 A, 1991, US 3421502 A, 1968, DE 3721595 A, 1988.
Address: 113811, Moscow, B. Serpukhovskaja 27, A.V. Vishnevsky Institute of Surgery, Russia Academy of Medical Sciences, patent department
(54) First-aid individual dressing package
(57) The invention belongs to the medicine, to be more concrete to the first-aid individual packages, intended to give the first medical, self care and mutual help in case of wounds, burns. First-aid individual dressing packages (IDP) consist of a cover made of a multi-layer combined material and a bandaging complex, including two multi-layer bolsters and the fixing bandage. One bolster is immovable, the other may move freely on the bandage. There are several types of the IDPs: AYB-4 – the bolsters have 4 layers - noninvasive, carbonaceous, sorption and defensive, AB-2 – the bolsters have 2 layers – noninvasive-sorption and defensive, AB-3 – the bolsters have 3 layers - noninvasive, sorption and defensive, AAB-4 - the bolsters have 4 layers - noninvasive, antimicrobial, sorption and defensive. The construction makes it possible to provide the first aid and to prevent the development of the wound infection. The construction provides the steadiness of the fixation and necessary starting pressure on the body, helping to lower the further wound damage and loss of blood.
(Picture)
1- immovable bolster
2- movable bolster
3- lap
4- bandage
5- bandage roll
RU 2164150 C2
2164150
The invention belongs to the medicine, to be more concrete to the first-aid individual packages, intended to give the first medical, self care and mutual help in case of wounds, ambustions.
We know the first-aid individual dressing package including a pack, cotton with antiseptic and a plaster for the bolster fixation on the wound surface (author’s certificate USSR 31578, A 61 F 13/02, 1932).
This pack is noninvasive due to the plaster fixation on the wound surface.
We know the first-aid individual dressing package including a gauze bandage and a compressive bolster attached to the inner side of the bandage in the middle. The outer side of the bolster has the support rod made of the tight flexible material, closing the locus. There is some glue on the inner side of the support rod. Due to this fact it is attached to the bandage and to the back side of the compressive bolster (US patent 3421502, A 61 L 15/00).
We also know the first-aid individual dressing package containing the bolster and the fixing element attached to the outer side (for example, bandage). The fixing element has two ends, one of which is of the limited length and another is in roll. The bolster has at least one loop (with the same size as the roll) situated close to the side of the limited length bandage or the cut, situated along the side part of the bolster (author certificate USSR 1635984, A 61 F 13/00, 1991).
According to the Union State Standard 1179-93 the modern first-aid individual dressing packages consist of a rubberized pack and the bandaging complex including two cotton-gauze bolsters and a gauze bandage.
The aim of the invention is to create some new noninvasive dressing products with the better functional features, which prevent the outer wound infection, the microflora development in subiculum and to provide the wound fixation steadiness.
First-aid individual dressing packages (IDP) consist of a cover made of a multi-layer combined material and a bandaging complex, including two multi-layer bolsters and the fixing bandage. One bolster is immovable, the other may move freely on the bandage. There are several types of the IDPs: AYB-4 – the bolsters have 4 layers - noninvasive, carbonaceous, sorption and defensive, AB-2 – the bolsters have 2 layers – noninvasive-sorption and defensive, AB-3 – the bolsters have 3 layers - noninvasive, sorption and defensive, AAB-4 - the bolsters have 4 layers - noninvasive, antimicrobial, sorption and defensive.
The noninvasive layer presents a net material made of knitted polyether fiber or a microfiber porous cover on the base of propylene fiber. (TOR 8390-022-05763369-95)
The carbonaceous layer consists of carbon nonwoven linen piercing fabric “KOMUPOL” (TOR 9393-132-00302327-96).
Sorption layer is the nonwoven linen piercing threadless hydroscopic fiber on the base of viscose or cotton or carbon fiber with the antimicrobial agent.
Lap 3 of the movable bolster 2 is situated along the bolster close to the side of the moistureproof (defensive) layer on the equal distance from its sides and is attached from both sides.
In the whole types of the packages the elastic medical fixation bandage “Unga-F” (TOR 9393-001-02951001) is used. For the bandage fixation the usage of the following materials are possible: safety pin, textile clasp (sticker, velkro, rubber band etc)
The unfolded end of the bandage is under the lap of the movable bolster and is attached to the unmovable bolster. The top side of the bandage is approximately on the distance of 4 cm from the top cross side of the bolster. The movable bolster should move freely on the bandage.
The lap of the movable bolster is made of unwoven polypropylene material (TOR 8390-022-05763369-95) or the medical gauze. (USS 9412-77).
The bolster surface should be even without any humps, nubs and dents.
Russian Federation (19) RU (11) 71 068 (13) U1
(the coat of arms) (51) MPK
A 61F 13/00 (2006.01)
Federal service of the intellectual property, patents and trade marks.
(12) The description of the useful model to the patent (title)
(21) (22) Request: 2007137672/22, 11.10.2007
(24) The date of the patent 11.10.2007
(46) Published: 27.02.2008 Bul. ¹ 6
Address: Moscow, Sumskoy proezd, 8, building 3, 22 floor, director general L. G. Shevereva
(72) Author (s): Shevereva Lubov Grigorjevna (RU), Efimenko Nikolay Alekseevich (RU), Adamjn Arnold Aramovich (RU), Dobish Svetlana Vasiljevna (RU), Sheverov Vladislav Vjacheslavovich (RU), Volkov Andrey Aleksandrovich (RU).
(73) Patent holder(s): LLC “Enterprise “Vladeks” (LLC “Enterprise “Vladeks”) (RU)
(54) First-aid individual dressing package (IDP)
(57) Useful model formulae
1. First-aid individual dressing packages (IDP) include two multi-layer bolsters and the fixing bandage. One bolster is immovable, the other may move freely on the bandage. The bolster have not less than 2 layers and the pack made of a multi-layer combined material. The layer which is in the contact with the skin has the additional bioactive layer, containing the metal entity from nanoparts of silver (80-99,7%), ferrum (0,1- 20%), aluminum (0,1-20%), cuprum (0,1-20%), which are applied in the vacuum camera with the help of magnetron deposition.
2. IDP (point 1) differs by the fact that the shape of the nanoparts is not more than 0,1 m
3. IDP (point 1) differs by the fact that the bolsters contain noninvasive-sorption (in contact with the wound surface) and defensive layers.
4. IDP (point 1) differs by the fact that the bolsters contain noninvasive (in contact with the wound surface), sorption and defensive layers.
5. IDP (point 1) differs by the fact that the bolsters contain noninvasive (in contact with the wound surface), antimicrobial, sorption and defensive layers.
6. IDP (point 5) differs by the fact that the antimicrobial layer contains medicinal substance.
7. IDP (point 6) differs by the fact that it contains antiseptic and antimicrobial components as medicinal substance.
8. IDP (point 6) differs by the fact that it contains herbals extracts as medicinal substance.
9. IDP (point 6) differs by the fact that it contains vitamins as medicinal substance.
10. IDP (point 6) differs by the fact that it contains antifungal agent as medicinal substance.
RU 71068 U1
LLC “Enterprise “Vladeks”
Juridical address: 117534, Moscow, Chertanovskaya Street, 54, 1
Factual address: 117519, Moscow, Varshavskoe highway, 132
Plant: 142211, Moscow region, Serpukhov, Soltsa Street, 1
Telephone Fax: (499) 270-62-01
Official web-site: http://www.vladeks.com
E-mail: vladeks.org@mail.ru
We produce modern first-aid individual dressing packages of a new generation!!!!
According to the RF Government statement, dated by 10.11.07 ¹ 775-35, in 2010 we designed and produced the bioactive wound covers with silver nanoparts.
The unique features of the products with silver covering are in the following:
- Silver parts have the antimicrobial activity to 152 types of the pathogenic microflora. The high chemical and biological activity of the nanoparts was proved during the different scientific and biological researches.
- The covering on the medical materials are highly active to the pathogenic microflora of both types (gram-positive and gram-negative), they do not cause any allergy and promote the wound and burns healing.
- They are noninvasive (as can be easily removed from the wound) due to the usage of the net knitted fabric, preserving its permeability and absorbability.
- The active action and curable effect of the silver nanoparts appear without any additional medicinal substances.
On the 14th of October, 2010 the Federal Supervisory Agency for Health Care and Social Development issued the Registration Certificate ¹ ÔÑÐ 2010/09024, which allows the serial production, sale and usage of the Individual noninvasive antimicrobial sterile first-aid packs “AB-3-NANO” and its types on the territory of Russia.
Prescription
Åðó first-aid individual dressing packages are used for the first medical aid, self care and mutual help. The first-aid individual dressing packages may be used as the primary bandage in hospitals, polyclinics, medical institutions, field conditions and household. IDP “AB-3-NANO” makes the necessary conditions for the primal trauma complication precautions. They may be used as the first and curable bandage.
There are no analogues in Russia. The analogues of the foreign companies (“Hartman”, “Johnson and Johnson”) cost 5 times higher.
Director general LLC “Enterprise “Vladeks” L.G. Shevereva
ITN 7726338321 IEC 772601001 OKVED 24.42.2, 73.10 NCBO 17777359
à/ñ 40702810740400101329
In Serpukhov Sberbank Department OJSC, Moscow
ñ/à 30101810400000000225 BIC 044525225
Specification
First-aid individual noninvasive antimicrobial sterile dressing packages“AB-3-NANO”
TOR 9393-012-17777359-2010
Prescription
The first-aid individual dressing packages are used for the first medical aid, self care and mutual help. The first-aid individual dressing packages may be used as the primary bandage in hospitals, polyclinics, medical institutions, field conditions and household. IDP “AB-3-NANO” makes the necessary conditions for the primal trauma complication precautions. They may be used as the first and curable bandage.
The first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3-NANO” (IDP“AB-3-NANO”) produced by the LCC “Enterprise “Vladeks”, consist of one bolster (immovable) or two bolsters (immovable and movable) and fixing gauze or elastic bandage. IDP“AB-3-NANO” is the combined bandage including: noninvasive layer with the nanostructural silver covering, sorption layer on the basis of the nonwoven linen piercing fabric from the mixture of cotton, linen and viscose fabric and defensive (waterproof) layer on the basis of nonwoven hydrophobic material.
Depending on the type of the noninvasive layer there are three types of the bandages:
1. The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the net fabric with the nanostructural silver covering. (“AB-3-NANO-1”)
2. The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the two-layer nonwoven fabric on the basis of polypropylene fibers with the nanostructural silver covering. “AB-3-NANO-2”
3. The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the three-layer nonwoven fabric with the covering on the basis of polypropylene fibers, armored net fabric and nanostructural silver covering. “AB-3-NANO-3”
The packages have the outer cover made of the polyethylene (USS 10354) and the individual pack of a combined material on the basis of aluminum foil (TOR 2245-041-00203536-97 or USS P 52145). The package sterilization is made with the traditional method with the dose of 2,0+/-0,5 millirad.
The packages meet the medical practice demand and are recommended to the production and medical use including the RF Ministry of Defense.
The first-aid individual noninvasive antimicrobial sterile dressing packages closely adjoin to the wound surface and provide the normal condition of the wound surface. The packages are plastic and soft enough and do not cause the pain syndrome to the patients while dressing.
Usage
The first-aid individual dressing packages are delivered in the hermetic pack, they are sterile. Before the bandage use it is necessary to wash the wound with the help of the antiseptic solution. The pack should be opened with sterile scissors, the bolster should be taken with the pincers. The bolster may be cut according to the wound shape and form. The bandage should be accurately pressed to the bottom of the wound. No sorption layer is needed. The bandage fixation is made by the standard method with the help of the gauze elastic sterile fixing bandage. The dressing should be made not less than one time a day. When the application as a net fabric with nanostructural covering is used it is possible to get the opportunity of the wound revision after taking off the sorption layer. In the case of the normal condition of the wound it is recommended to change the sorption layer without taking off the noninvasive one.
Do not afraid of water.
Any antiseptics are acceptable (for the skin around the wound surface)
Have no contraindications. No allergy.
Usage boundary conditions
It is forbidden to use “AB-3-NANO” with any ointments, alcohol solutions and aseptic means. It is forbidden to delete the silver parts from the wound surface after taking off the bandage.
1. The name of the organization or the surname and name of the individual entrepreneur who accepted the declaration of conformity:
LLC “Enterprise “Vladeks”
2. The information of the registration of the company or the individual entrepreneur (the name of the registration authority, the date of the registration, registration number)
Registered by the RF Federal Tax Service inspection ¹ 26, Moscow, 04.07.2005, registration number 1057726029877
3. Address, telephone, fax
Juridical address: 117534, Moscow, Chertanovskaya Street, 54, 1
Factual address: Moscow region, Serpukhov, Soltsa Street, 1
Telephone Fax: (499) 270-62-01
4. The post, the surname and the name of the director of the organization
In the person of director general Shevereva Lubov Grigorjevna
5. Declare that the first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3-
NANO”, TOR 9393-012-17777359-2010 in the three hardware versions: “AB-3-NANO-1”, “AB-3-
NANO-2” and “AB-3-NANO-3”
6. Producer : Produced by the LLC “Enterprise “Vladeks”, juridical address: 117534, Moscow, Chertanovskaya Street, 54, 1
7. The name, type and the brand of the service
FEACN 3005905500 RCP code 939300 TOR 9393-012-17777359-2010
8. The list of the documents the conformity with which proved by the declaration with the points of the documents which consist the demands for the mentioned products
Meet the demands of USS 1179-93 (points 1.2.2., 1.3.3., 1.3.4.), USS P ISO 10993.1-99, USS P ISO 10993.5-99, USS P ISO 10993.10-99, USS P ISO 10993.11-99, USS P ISO 10993.12-99.
9. Information of the documents which are the basis for the accepting of the declaration
The declaration is accepted on the basis of: the technical acceptance inspection act ¹ GTS 533/2010 dated by 18.06.2010, A.V. Vishnevsky Institute of Surgery and the RF Ministry of Public Health and Social Development (¹ FS 11-PTI-05, dated by 01.06.05), registration certificate of the Supervision Federal Serviceó in the field of Public Health and Social Development (¹FSR 2010/09024, dated by 14.10.2010). Validity date: unlimited. Toxicological conclusion ¹ 197-10Ï, dated by 02.11.2009, central commission of “OSC n.a. N.N. Blokhin”, attestation ¹ROSS RU.0001.21 FM69, dated by 06.07.2007, FS 04-PTI-04), TOR 9393-012-17777359-2010
10. The declaration is accepted on the 04.04.2011
11. The declaration of conformity is legal till 03.04.2014
(round stamp with the following text: LLC “Enterprise “Vladeks”)
Signature (signed) L. G. Shevereva
Information of the declaration of conformity registration
The name and the address of the certification authorities
The authorities on the certification of the bandaging, sutural and polymeric materials of the Federal State Institution “A.V. Vishnevsky Institute of Surgery of the RF Ministry of Public Health and Social Development”. The accreditation certificate is under ¹ ROSS RU. 0001.11IM09, dated by 26.08.2010, address 117997, Moscow B. Serpukhovskaja Street, 27 Tel/Fax (499) 236 50 54
Registration date: 04.04/2011 Declaration registration number: ROSS RU. IM09 Â 00013
Signature (signed) A.A. Adamjn
(round stamp with the following text: Authorities on the certification of the bandaging, sutural and polymeric materials of the Federal State Institution “A.V. Vishnevsky Institute of Surgery, ROSS RU. IM09 Â 00013)
Testing Laboratory
LLC “Quality Control Centre OSC n.a. N.N. Blokhin RAMS”
115478, Moscow, Kashirskoe highway, 24, tel.: 499 503-96-05, 8 499 503-93-19
The protocol of the toxicological tests of the medical materials on their biological safety.
¹ 197-10Ï November 2, 2009
|
The name of the material |
The first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” in the three hardware versions: “AB-3-NANO-1”, “AB-3- NANO-2” and “AB-3-NANO-3” |
|
Producer |
LLC “Enterprise “Vladeks”, Russia |
|
Declarant |
LLC “Enterprise “Vladeks”, Russia |
The tests are held in accordance with (the number and the name of the standard and other normative documents)
|
Standard series: USS P ISO 10993.1-99, 10993.10-99, 10993.11-99, 10993.5-99, 10993.12. “Characterization of the biological activity of the medical materials” “Digest of the leading methodical materials on the toxicological and hygienic researches of the polymer material and medical equipment on its base” USSR,1987 USS P 52770-2007. Medical products. Safety requirements. Methods of the sanitary-chemical and toxicological researches USS P ISO 11737-1-200 “Sterilization of the medical products. Microbiological methods” USS P 51148-98 “Medical products. Demands to the samples and documentation, presented to the toxicological and hygienic researches and researches on the sterility and pyrogenicity” |
Test results
|
¹ |
Index name |
Acceptable value |
Test results |
Conclusions |
|
1.1 |
Reparative additives, ml |
Not more 1,0 (0,02N natrium thiosulfate solution) |
0,28 |
correspond |
|
1.2 |
pH changes - humor |
Not more + 1,0 |
0,38 |
correspond |
|
1.3 |
Ultraviolet absorption |
Not more 0,3 (230-360 nm) |
0,225 |
correspond |
|
1.4 |
Formalin, mg/l |
0,100 |
0,011 |
correspond |
|
2. |
Toxicological tests results |
|||
|
2.1 |
Irritation effect on the animal’s skin and mucosal |
|||
|
|
Eye mucosal of a rabbit |
0 |
0 |
correspond |
|
|
Skin |
0 |
0 |
correspond |
|
2.2 |
Cytotoxicity |
|||
|
|
Cytotoxicity on the suspended short-term culture of the mobile cell |
Toxicological index is 70-120% |
103,1% |
correspond |
|
2.3 |
Sterility |
|||
|
|
Sterility |
sterile |
sterile |
correspond |
|
Conclusions on test results The samples correspond to the demands imposed on the medical products; their humor did not exert the harmful influence on the biological objects. |
Conclusion
|
The first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” in the three hardware versions: “AB-3-NANO-1”, “AB-3- NANO-2” and “AB-3-NANO-3”, produced by LLC “Enterprise “Vladeks” are nontoxic, sterile and meet the normative documents demand. |
They are recommended to the usage by the nontoxic index.
Responsible for the tests (signed) Pavlenko E.N.
(round stamp with the following text: LLC “Enterprise “Vladeks”)
(round stamp with the following text: LLC “Quality Control Centre OSC n.a. N.N. Blokhin RAMS”, Moscow, RF )
“Approve”
The head of the FSI “3 CMH n.a. A.A. Vishnevsky”,
RF Ministry of Defense,
major-general of the medical service
(round stamp) (signed) S.A. Beljkin
March 15, 2011
The protocol
regarding the state clinical tests of the following medical products: the first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” with the nanostructural silver covering, produced by LLC “Enterprise “Vladeks”
According to the Instruction “Regarding the order of the preclinical researches of the medical means, clinical researches of the medical specimens, medical products and medical techniques sample tests”, approved by the head of the Main Military Medical Department, RF (30.10.2010) and the MMMD permission ¹161/1/6/56 (17.01.2011) the state clinical tests of the following medical products: First-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” with the nanostructural silver covering, produced by LLC “Enterprise “Vladeks” were held. The tests were held in the department of the purulent surgery of the FSI “3 CMH n.a. A.A. Vishnevsky”, RF Ministry of Defense in the period of February 1, 2011 till March 5, 2011.
Test purpose
The test purpose is to prove that the first-aid individual noninvasive antimicrobial sterile dressing packages “AB-3- NANO” correspond to the technical characteristics of TOR 9393-012-17777359-2010 and to prove their biological activity and medical effectiveness.
Tests reason
- The permission ¹161/1/6/56 of the head of the Main Military Medical Department, RF, dated by 17.01.2011
The following documents were represented for the state tests:
- The file of the documents including the normative document, product certificate, description , program of the clinical tests
- Toxicological conclusion ¹ 197-10 P dated by 2.11.2009 given by the LLC “Quality Control Centre OSC n.a. N.N. Blokhin RAMS”
- Technical tests protocol ¹ ÃÖ 533/2010 dated by 18.07.2010, given by A.V. Vishnevsky Institute of Surgery
- Registration certificate ¹ ÔÑÐ 2010\09024 dated by 14.10.2010
- The samples of the medical products – the first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO”
The short technical characteristic of the test product and its prescription.
For the state tests the samples of the first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” were presented. The first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” consist of bolsters and a bandage. The first-aid individual dressing packages (IDP AB-3) consist of one bolster (immovable) or two bolsters (immovable and movable), the shape of the bolsters is 25 to 15 cm. The bolsters are combined and include: the noninvasive layer with the nanostructural silver covering, the sorption layer on the basis of the nonwoven linen piercing fabric from the mixture of cotton, linen and viscose fabric and the defensive (waterproof) layer on the basis of the nonwoven hydrophobic material.
Depending on the type of the noninvasive layer there are three types of the bandages:
1. The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the net fabric with the nanostructural silver covering. (“AB-3-NANO-1”)
2. The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the 2-layer nonwoven fabric on the basis of polypropylene fibers with the nanostructural silver covering. “AB-3-NANO-2”
3. The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the 3-layer nonwoven fabric with the covering on the basis of polypropylene fibers, armoured net fabric and nanostructural silver covering. “AB-3-NANO-3”
For the noninvasive bolster layer the noninvasive antimicrobial fabric with the nanostructural silver covering is used. The fabric “Nano-Aceptic” has three variants of the performance (TOR 9393-003-98187390-2009). The packages are produced with gauze or elastic fixing bandages. For the fastening of the bandage the safety pin is used. The fixing elastic bandages have the clasp “Contact”.
The packages have the outer cover made of polyethylene (USS 10354-82) and the individual pack of a combined material on the basis of aluminum foil (TOR 2245-041-00203536-97)
For state tests the packages were represented in sterile packs.
Test results
The packages were used for the treatment of the 17 patients with granulating wounds of different etiology and location in the regeneration stage. Two patients had surface burns, five patients were after autodermoplasty. The packages were also used for the covering of the operating wounds with rhaphes (10 patients) and for the covering of the traumatic injuries of the skin (2 patients). The age of the patients varied from 22 to 60 years.
Before the usage of the bandage the wound surface was treated with the antiseptic solutions. The outer package was torn up, the polyethylene cover was removed. Then the bolsters were unfolded and put to the wound with the silver cover side. The bolsters were accurately pressed to the bottom of the wound. The bolsters’ fixation was made by the standard method with the help of the gauze or elastic fixing bandage. The dressing was held every day or in a day depending on the quantity of the traumatic discharge.
The packages “AB-3- NANO” were used for the covering of the skin donor site (5 patients). The gauze drape was put on the top of the net fabric. The gauze drape was changed during the dressing. After the full adhesion of the wound the net base was easily removed. The packages “AB-3- NANO” were also used as a cover on the transferred skin flap. The control for the wound process was made through the net fabric.
The packages “AB-3- NANO” were used for the granulating wound treatment of different etiology, posttraumatic and thermal wounds. The control for the wound process was made with the help of the microbiological tests, wound adhesion period and the involution of the wound surface.
The bolsters were easily molded on the plain wounds. The taking off of the bandage was easy and practically painless, without any traumatizing of the granulating skin, except the wounds with little discharge. The net fabric was not removed from the wound until the full adhesion. The noninvasive features are worse in the packages “AB-3- NANO-2”. (a thicker noninvasive layer).
The sorption capacity is the same in all the types and it is enough for the granulating and post traumatic wound treatment.
The bandages can be easily fixed on different parts of the body, including diarthroses. The bolster form and shape is enough for the first medical aid. 4 patients have the pain syndrome in upper limbs when fixing with the elastic bandage because of the compression of the soft tissues.
There was no reinfection of the wounds. This is explained by the fact that the packages produced by LLC “Enterprise “Vladeks” possess the antimicrobial features. According to the dynamic bacteriological tests the better antibacterial effect was in the group were the packages“AB-3- NANO-3” were used. The decrease of the bacteria quantity lower the “critical point” was gained on the third day and was 1,5x104 m.t. in 1 gram of the skin.
The wound surface involution speed was 2,8 +0,3 % a day which coincides the course of the wound process with the help of traditional means. There was no maturation of donor and operation wounds. 3 patients had the full engraftment of the skin (the whole wound surface), 2 patients had 80% engraftment of the skin.
The results of the research are the following:
1. The first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” have the comfortable pack; the shape of the packages coincides with the acceptable samples.
2. The sorption qualities are the same in all variants and are enough for the first medical aid, self care and mutual help and also for the treatment of granulating wounds of different etiology and location.
3. The antimicrobial activity is enough to prevent the recontamination. The packages “AB-3- NANO-3” have better antimicrobial activity.
4. All the bandages are noninvasive when taking off. The noninvasive features are a worse in the packages “AB-3- NANO-2”.
5. The regeneration and adhesion processes on the second stage of the wound process are equal to the processes happen with the help of traditional means.
6. The samples cause no allergy reactions and changes of the skin.
7. The bandages can be easily put on residual limbs, breast and other parts of the body, It is necessary to dose the tension while using the elastic bandage. Gauze bandage are faster to fix.
Conclusion.
On the basis of the state tests we consider the first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” with the nanostructural silver covering, produced by LLC “Enterprise “Vladeks” coincide the demand of the state technical conditions (TOR 9393-012-17777359-2010). The first-aid individual noninvasive antimicrobial sterile dressing packages “AB-3-NANO” have enough biological activity and may be recommended for the serial production for medicine aims (including the RF Ministry of Defense).
The commission chairman:
Deputy manager on the medical service, (signed) B.L. Shklovskii
medical service colonel,
master of medical sciences
The members of the commission:
The head of the scientific-methodical department (signed) M.N. Frolkin
The head of the purulent surgery department,
doctor of medical sciences (signed) I.N. Shandurenko
The head of the scientific-medical branch
of the scientific-methodological department (signed) O.I. Sheikina
“Approve”
The chief medical officer of SCH ¹15 n.a. O.M. Filatov
Professor: Tjulkin E.E.
(round stamp)
The protocol of the clinical tests
First-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO”
In the clinic of hospital surgery ¹1 SEI HVE of the Russian State Medicine University on the base of town clinical hospital ¹15 n.a. O.M. Filatov since 22.06.10 till 12.07.10 the medical tests of the first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” with the nanostructural silver covering, produced by LLC “Enterprise “Vladeks” were held.
The tests were held for:
Variant 1.
The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the net fabric with the nanostructural silver covering. (“AB-3-NANO-1”) (01-a OÏ)
Variant 2.
The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the 2-layer nonwoven fabric on the basis of polypropylene fibers with the nanostructural silver covering. (“AB-3-NANO-2”) (02-a OÏ)
Variant 3.
The first-aid individual noninvasive antimicrobial sterile dressing packages with the noninvasive layer on the basis of the 3-layer nonwoven fabric with the covering on the basis of polypropylene fibers, armored net fabric and nanostructural silver covering. (“AB-3-NANO-3”) (03-a OÏ)
Technical documentation:
1. The technical tests act of the first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” held in the A.V. Vishnevsky Institute of Surgery (act ¹ 533/2010, dated by 18.06.10)
2. The toxicological tests conclusion held in the LLC “Quality Control Centre OSC n.a. N.N. Blokhin RAMS” (¹97-10P, dated by 02.11.10)
3. The clinical tests program approved by V.D. Fedorov, the head on the scientific work of A.V. Vishnevsky Institute of Surgery.
The medical tests were held in accordance with the program and methodic of the medical tests (USS R.15.013-94). The first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” with the nanostructural silver covering, produced by LLC “Enterprise “Vladeks” were used for the treatment of the patients in the purulent surgery department of SCH ¹15 n.a. O.M. Filatov after the preliminary oral agreement of the patients. There were no patients’ complaints and claims during the tests.
The existence of the sharp and chronic infected wounds of different origin became the evidence to the usage of the packages. There were no patients with purulent-necrotic and coagulation necrosis wounds.
22 patients took part in the tests; ten of them were with the wounds after surgical phlegmon treatment of different location (hip, forearm, lower leg and foot. 5 patients had the infected venous ulceration of the lower leg, 2 patients had wound and ulceration defects with the neuropathic form of the diabetic foot syndrome, 2 patients with burns of the II and III stages, 2 patients with the rump bedsores and 1 patient had the sharp surface wounds of the hip after taking the skin flap.
There were 50% of men and 50% of women.
The average patient age was 56,1+/- 6,3 years.
The surface of the wound defects was from 70 to 280 sm2. The length of the package usage was from 4 till 11 days.
It was stated that the packages have the outer cover of the polyethylene and an individual pack made of the combined material on the basis of aluminum foil. There is full information about the product on the pack. The pack contains the sterile wound cover (2 bolsters connected with the elastic bandage with the clasp “Contact”). There were no damages of the packs.
The methodology of the application was standard for all the patients. After the wound sanitation made with antiseptic solutions the bolsters were put to the wound with the silver covered side and fixed with the help of the elastic bandage. If necessary the additional fixation was made. The dressing was held every day.
The packages of the “variant 1 ”were used on the weak and normal exude wounds, including the patients with donor wounds, burns of the II stage and venous ulceration of the lower leg, in the II and III stages. The packages had a good adhesion to the wound surface and a good modeling of the wound surface including the diarthroses. The removal of the bandage was easy and practically painless, without any traumatizing of the granulating skin. There was no reinfection of the wounds. In case of the surface wounds the adhesion came in 7-10 days.
The packages of the “variant 2 and 3” were used on the normal and high exude wounds, which were in the I and II stages of the wound process. The packages had a good modeling of the wound surface but there were some difficulties when it was used on the wounds of complicated shape that fact had the connection to the bandage structure rigidity. The compression therapy with the usage of the elastic bandages was used on the patients with venous ulceration. The taking off of the bandage was easy and practically painless, without any traumatizing of the granulating skin. The wound covering had the good absorption for the wounds with normal and high exudation. The outer layer remained dry. The removal of the bandage was easy and practically painless, without any traumatizing of the granulating skin. There was no reinfection of the wounds. All the patients showed the positive dynamic of the wound process with the fast abort of the inflammatory processes. When achieving the abort of the inflammatory processes in the wound the bandage may be changed in a day. After the microbiological researches it became clear that 14 patients have the decrease of the bacterial content in 2-3 order happened during 5-7 days (lower the critical level (1g5 COE/ä). 6 patients had no microflora growth. 2 patients had the healed wounds on the moment of the research.
The tests proved that the wound covers do not have any damaging and annoying effect on the skin, cause no allergy and comfortable in usage. There was no any allergy on them. There were no any complications or negative development of the process. The existence of the fixing elastic bandage helps to deal without any additional fixation in most cases. Taking into account the structure of the packages we can consider that they are intended for the wounds localized on the upper and lower limbs. The packages need some additional fixation in cases with another localization of the wound.
Conclusion:
The first-aid individual noninvasive antimicrobial sterile dressing packages“AB-3- NANO” with the nanostructural silver covering, produced by LLC “Enterprise “Vladeks” meet the medico-technical demand and may be recommended to the wide clinical usage. The bandages may be used in polyclinic, general health institutions and in cases of the home, field or other conditions for the treatment of the green and infected sharp and chronicle wounds of different origin.
The head of the septic surgery department
Lecturer of the hospital surgery department ¹1 (signed) Gorunov S.V.
Deputy Chief Doctor on surgery
Professor of the hospital surgery department ¹1 (signed) Abramov I.S.
24.08.10
“VLADEKS +” LLC “Enterprise “Vladeks”
“Vladeks” – is the modern scientific and production enterprise, specialized in the field of development, uptake and commercialization of modern different high functional dressing products.
All the production is developed in association with the medical specialists of the A.V. Vishnevsky Institute of Surgery and the RF Ministry of Defense and registered in the Ministry of Public Health and Social Development. The production is certified and corresponds to the world analogue level. The developed production and its manufacturing technology hold RF patent.
We offer a new unique innovation project!!!!
New IDP AYB-4
On the order of the RF Ministry of Defense we developed and implemented a unique first aid individual sterile dressing package with the carbon sorbent - IDP AYB-4. This package provides the antimicrobial action due to the carbon fiber which can actively remove the pathologic microflora out of the wound.
The main indications to the usage of the composite carbon sorbents in IDP AYB-4 are the following:
- The treatment of the surface and rudimentary wounds including burns
- The treatment of the infected wounds with limited discharge
- The preparation of the granulating wounds to the autodermoplasty
The unique features of the IDP AYB-4 are the following:
- The bandage has the good ability to absorb the wound secretion, providing good sorption effect, it lowers the bacterial contamination of wounds and trophic ulcers. Remove the exudates odour.
- The first aid individual sterile dressing package with the carbon sorbent is invasive due to the usage of the net knitted fabric, preserving its hygroscopic properties.
- The first aid individual sterile dressing package with the carbon sorbent may stay for 7 days on the wound
- Effectively used on the patients with allergy to the medical products
In July 2010 the Ministry of Public Health and Social Development issued the registration certificate ¹ ÔÑÐ 2010/08170, which allows the serial production, sale and usage of the first aid individual sterile dressing packages in different versions on the territory of the RF.
Prescription:
The first-aid individual dressing packages are used for the first medical aid, self care and mutual help in hospitals, polyclinics, in cases of home, production and road-transport traumas. The carbon sorbent provides necessary conditions for the prevention of the primal traumas complications. The package may be used as the first aid medical bandages.
There are no analogues in Russia.
Address: 142211, Moscow region, Serpukhov, Soltsa Street, 1
Telephone Fax: (499) 270-62-01
Juridical address: 117534, Moscow, Chertanovskaya, 54 -1
Mail address: 142211, Moscow region, Serpukhov, Soltsa Street, 1
Official web-site: http://www.vladeks.com
E-mail: vladeks.org@mail.ru
Certification system USS P
Federal Agency for Technique Regulation and Metrology
(stamp) USS Russia Certificate of Conformity
¹ÐOÑÑ RU.ÈÌ09.Â02664
Period of validity since 31.08.2010 till 30.08.2013
¹0302337
Certification authorities of the bandaging, sutural and polymer materials of the Federal State Institution “A.V. Vishnevsky Institute of Surgery” of the federal agency on the highly technologicalmedical aid, ¹ÐOÑÑ RU.ÈÌ09.Â02664, dated by 26.06.2009.
117997, Moscow, B.Serpukhovskaya Street, 27, telephone/fax (495) 236-50-54
The production the first-aid individual dressing packages RC code 005 (RCP)
9393000
The serial production TOR 9393-01-1777359-98 (not. of changes ¹ 1, 2, 3, 4)
Coincide with the demands on the normative documents:
USS P ISO 10993.1-99, USS P ISO 10993.4-99, USS P ISO 10993.5-99, USS P ISO 10993.10-99, USS P ISO 10993.12-99, USS P ISO 11737-2000, USS P 51148-98; “Digest of the leading methodical materials on the toxicological and hygienic researches of the polymer material and medical equipment on its base” USSR,1987
Producer: LLC “Enterprise “Vladeks”, 117534, Moscow, Chertanovskaya, 54 -1, ITN 7726338321
The certificate issued: LLC “Enterprise “Vladeks”, 117534, Moscow, Chertanovskaya, 54 -1, ITN
7726338321, Telephone Fax: (499) 270-62-01
On the basis of:
- The protocol of the certification tests ¹4122, dated by 30,08.2010 ÈÖ of the bandaging, sutural and polymer materials (accreditation certificate ¹ÐÎÑÑ RU.0001.21 ÔÂ01, dated by 05.03.2008)
- The registration Certification of the Ministry of Public Health and Social Development ¹ÔÑÐ 2010/08170, dated by 07.07.2010., period of validity is unlimited
- The protocol of the toxicological tests ¹ 222-09Ï, dated by 10.09.2008 , LLC “Quality Control Centre OSC n.a. N.N. Blokhin RAMS” ,(accreditation certificate ÃÑÝÍ.RU.ÖÎÀ.495, dated by 17.07.2008)
Additional information: The labeling of the production with the conformity mark is made by USS P 50460-92. Scheme certification number is 3. The control is to be held once a year.
(round stamp with the following text: Certification authorities of the bandaging, sutural and polymer materials of the Federal State Institution “A.V. Vishnevsky Institute of Surgery” of the federal agency on the highly technology medical aid ROSS RU.0001.11IM09)
The head of the agency (signed) A.A. Adamjn
Expert (signed) L.A. Blinova
(round stamp with the following text: LLC “Enterprise “Vladeks”)
The certificate has the juridical force on the whole territory of the Russian Federation
“Approve”
The head of the State Military Clinical Hospital n.a. N.N. Burdenko
Master of the medical science (signed) V. Kluzhev
May 21, 1998
(round stamp with the coat of arms)
Report
on the clinical tests of the first aid bandaging means
According to the program and the methodic of the clinical tests of the A.V. Vishnevsky Institute of Surgery, the clinical tests of the first aid bandaging means were held in the State Military Clinical Hospital n.a. N.N. Burdenko in the period of March-April 1996.
Four types of the first aid bandaging means took part in the tests:
- The first aid noninvasive carbon waterproof dressing packages and the first aid noninvasive carbon dressing packages (AYÂ-1, AYÂ-2, AY)
- The first aid noninvasive waterproof dressing packages and the first aid noninvasive dressing packages (AÂ-1, AÂ-2)
- The first aid noninvasive antimicrobial waterproof dressing packages (AAÂ-3 with defensive layer and without it)
- The first aid noninvasive dressing packages (A)
The clinical tests were held on 15 patients within the age from 20 to 85 years. The most patients had the comorbidity including oncological diseases. 50 dressings were made on the clear postoperative wounds, donor surfaces after the dermanaplasty, slow granulating wounds and infected wounds. The dressing packages were used in combination with sorbents, antiseptics, ointments, gels and collagen preparations and also without any additions.
The clinical tests proved the following:
1. All the variants of the dressing packages meet the demand:
- No remarks on the construction
- The material is comfortable for the making the bandages of smaller shape, can be easily cut with the scissors
- The bandages model well to the wound surface
- The preparation and the dressing of the package do not take much time (time-saving)
- The material has good absorption characteristics and do not detain the outflow of the wound discharge.
- The material structure stays the same before and after the usage
2. The material is noninvasive. The most preferable is the noninvasive layer in the form of net fabric on the basis of polyester fiber.
The optimal time for the bandage standing on the wound is 1-2 days. Then the bandage soaks in the wound discharge and hurt the patient during the removal.
3. The bandages have the optimal sorption; they are water and microbial proof.
The bandage has the good sorption of the wound discharge; the top layer stays dry even if the wound discharge is high. When staying on the wound during 5-7 days the dressing become too hard because of the sorption of the wound discharge.
4. The high adhesive features and vapour permeability of the material make the wound staying for several days possible without any decline of the characteristics. The full adhesion of the donor wounds happen during 14 days. (the bandages were not changed)
5. There was no contamination of the “tidy” wounds. The bandages with the antimicrobial and carbon layers also gave the clearing effect and stimulated the granulation of the wound. According to the microbiological tests there was no any increase of the microflora under the bandages.
6. The bandages of “A” and “AB” types were used in the combination with sorbents, antiseptics and collagen preparations. The bandages without the defensive layer have the good drainage capacity of the material.
7. The bandages of “AA”, “AY” and “AB” types preserve the wound discharge well that fact makes possible to do the dressing in 1-2 days.
The conclusion.
The dressing bandages meet the modern demand, they are comfortable in the usage, better the treatment results, have good appearance and create comfortable conditions for the patients.
We consider it is effectually to create the individual dressing pack consisting of two bolsters. One bolster is with the carbon bandages, another – with the antimicrobial layer or (with a view to economy) the noninvasive layer.
The dressing bandages may be recommended for the wide medical usage and commercial exploitation.
The final conclusion can be done after the tests in the field conditions.
Surgeon-in-chief of the State Military Clinical Hospital n.a. N.N. Burdenko,
Professor, the doctor of the medical sciences (signed) N. Efimenko
The head of the free and sealed isotopes cabinet
of the ratio surgical department
Master of the medical sciences (signed) O. Nuzhdin
IDP AYÂ-4
The first aid individual noninvasive carbon waterproof dressing package, providing the elective sorption of the wound microflora.
(picture)
1. The knitted net fabric
2. The carbon layer
3. The sorption layer (linen piercing and needle-punched hydroscopic medical fabric)
4. The loops of the fibers of the hydroscopic fabric (mechanical fastening)
5. The defensive layer (nonwoven polypropylene material)
“VLADEKS +” Production assortment
Dressing materials and means
For the providing of the optimal cure and prophylactic effect the first aid dressing product must meet the following special demands including: they must be noninvasive to the wound surface during the laying on and the removal, to have the optimal sorption ability, to prevent from the outer contamination of the wounds, to show the antimicrobial activity, providing the adhesion of the wounds.
1. The nonwoven and needle-punched sorption medical fabric is the basis for the widening of the assortment of the biologically active compositions. It effectively substitutes the cotton and gauze in the modern dressing means and has a high sorption ability regarding the wound discharge. The method of the mechanical fastening of the fabric on the base of the cotton and viscose fibers is in the base of the fabric production.
The two-layer nonwoven hygroscopic medical fabric forê the production of the dressing means “Mediteks”.
The fabric has high sorption ability. The knitted net fabric is used as a noninvasive layer, contacting with the wound surface. This fabric provides painless removal of the dressing (the same principle is used in production of the sorption noninvasive combines dressing etc.)
The modern medicine should have the wide assortment of the effective dressing materials and means with different medical formulae and their combinations for the first aid help.
The unwoven sorption noninvasive antimicrobial unsterile fabric.
The fabric consists of three layers: antimicrobial, sorption and noninvasive. The fabric is used in the production of the antimicrobial sorption noninvasive combined bandages. The following healing forms are used as antimicrobial components: chlorhexidine, miramistine, dioksidin.
2. The nonwoven sorption noninvasive antimicrobial sterile first aid bandages used on thermal burns, surface wounds and granulating wounds ÏAA – “Mediteks” with the healing components in the sorption layer: chlorhexidine, miramistine, dioksidin.
The noninvasive layer consists of the knitted net of the medical purpose. The bandages are sterile and of several shapes: 6x10 cm, 10x10 cm, 10x20 cm, 15x25 cm, 50x50 cm. The bandages are in the individual packs made of laminated paper or combined stretch materials.
3. Individual sterile dressing packages (IDP AÂ-3)
Indication: The first-aid individual dressing packages are used for the first medical aid, self care and mutual help in case of wounds, ambustions on the first stages and in cases of the home, production and road-transport traumas for wounds, ambustions, bed sores, trophic ulcer and other damages.
IDP bolsters consist of two bolsters (immovable and movable) and fixing gauze or elastic bandage. They have three or four layers: noninvasive (made on the basis of the knitted net providing the minimal adhesion to the wound) sorption (on the basis of the bleached cotton viscose or cotton linen and viscose fibers) and defensive (on the basis of nonwoven fabric).
The production of the other variants of the packages is also possible:
- IDP AAÂ-4 (noninvasive, antimicrobial, sorption, waterproof)
- IDP AYÂ-4 (noninvasive, carbon, waterproof, providing the selective sorption of the wound microflora )
All the IDPs have a high sorption ability and are noninvasive (do not glue to the wound surface and may be painlessly removed). They are water and microbial proof.
4. The noninvasive two layers drapes “Mediteks” made of the knitted medical net material and the fiber sorption fabric. They are sterile and may be used as a first aid and healing bandages on wound and burns treatment.
The drapes are intended for the first aid treatment of different traumas and infected wounds. They may be used in hospitals, polyclinics, medical institutions, field conditions and household.
The drapes are sterile and are produced of different shapes: 6õ10 cm, 6õ15 cm, 10õ10 cm, 10õ15 cm, 10õ20 cm, 15õ15cm, 15õ25 cm, 50õ50 cm.
5. The combined noninvasive sorption compression sterile bandages.
The bandages are made of the basis of the “Mediteks” fabric and represent a drape with the shape of 10õ10 cm, linked with the elastic bandage; the length of the bandage is not more than 3 sm. The bandage is used for the creation of the necessary pressure in the contact zone of the patient body.
6. The nonwoven sorption noninvasive antimicrobial sterile first aid bandages for thermal burns, surface wounds and granulating wounds ÏAA – “Mediteks”
Indication: The laying for the breast splits
In 2010 the enterprise started the production of the new materials. The assortment is well known and is in high demand due to the low price.
7. Nonwoven bandage under plaster.
The bandage is made of the needle-pinched material on the base of the polythereal fabric. The bandage is used as a defensive layer before the plaster or syntactical bandages. The bandages are produced in rolls:
- Width (cm) 10,0+1,0, length (m) 1,0 +0,1
- Width (cm) 10,0+1,0, length (m) 3,0 +0,2