DMC Bleed STP Manual Del Usuario

9. EFECTOS COLATERALES
No hay relatos de efectos colaterales de este producto.
10. CONTRAINDICACIONES
▪ No mezclar esta sustancia con vasoconstrictores: epinepherína, epine-
frina racémica, cloratos de hierro, sulfato férrico, clorato de aluminio, etc;
▪ No inyecte, ni use el Bleed STP en vasos sanguíneos, pues puede ocurrir
embolizacion u óbito;
▪ El Bleed STP no está recomendado en el tratamiento primario de distur-
bios de coagulación;
▪ No fueron realizados test con el uso de Bleed STP en superficies óseas
antes de la colocación de materiales protéticos con adhesivos; por lo tan-
to, tal utilización no es recomendada;
▪ No aplique mas de 50 g de Bleed STP en pacientes diabéticos, pues,
según los cálculos, cantidades superiores a esta pueden influencias los
niveles de glicosis.
11. CUIDADOS
▪ Utilizar el Bleed STP hasta la fecha de validad;
▪ Después de la ruptura del embalaje del papel grado quirúrgico (embalaje
estéril), utilizar el Bleed STP inmediatamente;
▪ El Bleed STP fue proyectado para ser utilizado en estado sólido, y su
eficacia hemostática disminuye cuando está en contacto con soluciones
salinas o con antibióticos antes de la hemostasia;
▪ En procedimientos urológicos, no se debe dejar el Bleed STP en la pelvis
renal o en los uréteres, a fin de eliminar posibles focos de formación de
cálculos.
12. VALIDAD
El producto posee validad de 2 años a partir de la fecha de fabricación.
Después de la abertura del embalaje papel grado quirúrgico (terciario y
secundario), el mismo deberá ser usado inmediatamente.
ENGLISH
1. BLEED STP COMPOSITION
▪ Natural vegetable polysaccharide.
2. FUNCTION AND INDICATION
Bleed STP has as function the blood natural hemostasy through hydrophi-
lic particles of natural vegetable polysaccharide. The product is indicated
for general surgical procedures.
There are not specific studies regarding the use of the product in the
ophthalmological area.
WARNING
This product is of restricted use to the surgeons dentists/doctors and
professionals of the rescue area.
OBSERVATION
The product is absorbed by the organism in a period between
24 - 48 hours.
3. ACTION MECHANISM
Bleed STP, in contact with the blood, absorbs the most fluid part of this
(plasm), forming a gel. In the extremities of this gel, platelets, red glo-
bules and the other blood constituent are concentrated, speeding up the
natural process of hemostasy
4. PRESENTATION FORMS
BLEED STP is commercialized in the following Kits:
▪ Kit 1:
- 1 applicator (wind type) with 1 or 3 or 5 grams
of Bleed STP;
- 1 User Manual.
▪ Kit 2:
- 3 applicators (wind type) with 1 or 3 or 5 grams
of Bleed STP each;
- 1 User Manual.
5. STORAGE AND TRANSPORT
Keep in place protected of direct light, heat and far from the children
reach. Store the product in ambient temperature.
6. STERILE PRODUCT
The product is supplied sterile, therefore the packing must be sealed up
before the use. Bleed STP is sterilized with gamma ray.
WARNING
The material cannot be re-sterilized. In case that it has material sur-
plus after the use, this will have to be discarded.
7. USE INSTRUCTIONS
1) Open the external packing (quaternary) and verify if the tertiary and
secondary packings (surgical degree paper) are unbroken;
2) Open the tertiary packing (surgical degree paper) at the moment of the
surgical table preparation;
3) Open the secondary packing (surgical degree paper) only at the mo-
ment of the product application;
4) Apply the product directly on the place that occurs the bleed and pres-
sure it lightly with a gauze. If the bleed persists, remove the product
excess and repeat the application;
5) After 30 seconds, remove the gauze and verify if the bleed was in-
terrupted. Use water or serum to humidify the gauze at the moment of
removing it.
WARNING
Bleed STP increases its volume when in contact with liquids. In this
way, the material excess must be removed after the hemostasy
process.
8. SECURITY GENERAL INSTRUCTIONS
▪ Restricted use of the professional Dentist Surgeon /Surgeon and profes-
sionals of the rescue area;
▪ The application of this hemostatic must be restricted to the treatment area;
▪ This product must be manipulated by the operator with protection gloves;
▪ Once the hemostasy is gotten, the excess of Bleed STP must be removed
from the application place irrigating and inhaling, mainly when used in
osseous foramen, regions of osseous confines, the spinal marrow, and/
or the nerve and optic chiasmus. The product increases its volume when
in contact with liquids. The dry and white Bleed STP that remains after
the application must be removed, therefore the removal of the dry ex-
cess material reduces the possibilities of the product to intervene in the
normal physiological functions and/or to cause necrosis for compression
of adjacent tissues;
▪ The security and the effectiveness of Bleed STP had not been tested cli-
nically in children or in pregnant women. It was observed that the amylase
activity is lower in babies born and babies until the first ten months of life;
therefore, Bleed STP can take more than 48 hours to be absorbed in this
population;
▪ Bleed STP must be used with care if there is infection or if used in con-
taminated areas of the body. If there is any signal of abscess or infection
after the application of Bleed STP, a new intervention for draining can be
necessary;
▪ Safety and effectiveness in ophthalmological procedures are not known.
▪ Bleed STP must not be used to control hemorrhage after-childbirth or
menorrhagy.
9. COLLATERAL EFFECT
There aren't stories about collateral effect of this product.
10. COUNTERINDICATION
▪ Do not mix this substance with vase-constritors: epinepherine, racemic
epinefrine, iron chlorides, ferric sulphate, aluminum chloride, etc;
▪ Do not inject, nor use Bleed STP in sanguineous vases, therefore it can
occur embolization or death;
▪ Bleed STP is not recommended in the primary treatment of coagulation
riots;
▪ Tests with the use of Bleed STP in osseous surfaces before the rank of
prosthetic materials with adhesives had not been carried through; there-
fore, such use is not recommended;
▪ Do not apply more than 50 g of Bleed STP in diabetic patients, therefore,
according to calculations, superior amounts than this can influence the
glucose levels.
11. CARES
▪ Use Bleed STP until the validity date;
▪ After the rupture of the surgical degree paper packing (sterile packing),
use Bleed STP immediately;
▪ Bleed STP was projected to be used in the solid state, and its hemostatic
effectiveness diminishes when in contact with saline solutions or antibio-
tics before the hemostasy;
▪ In urologic procedures, must not leave Bleed STP in renal pelvis or ure-
ter, in order to eliminate possible focus of calculus formation.
12. VALIDITY
The product possesses validity of 2 years from the manufacture date.
After the opening of the surgical degree paper packing (tertiary and se-
condary), the same must be used immediately.
Manual do Usuário
Manual del Usuario
User Manual