INTENDED
USE OF THE DEVICE
Device used to prepare intra-articular injections into the knee for symptomatic treatment of articular pain and mobility improvement. Device used to prepare intra-dermal injections for hydration of dehydrated and wrinkled skin tissues.
DESCRIPTION
The BCT-HA Kit is composed of sterile and non-pyrogenic tubes designed to prepare autologous Platelet Rich Plasma (PRP) combined with Hyaluronic Acid (HA). Each BCTHA Kit contains 3 BCT-HA tubes in independent blisters. The BCT-HA tube contains: a gel of hyaluronic acid, a cellselector gel and a liquid anticoagulant. The BCT-HA tube allows the preparation of about 4 ml of PRP/HA mix (about 2 ml of PRP combined with 2 ml of HA). The BCT-HA tube is for single use only and is designed to be used with sterile and single-use phlebotomy material. We recommend the use of 21G butterfly needle with tubing and blood collection holder to have gentle blood flow for tube filling. Blood withdrawal accessories are supplied separately in Accessory Set (ref. : BCA-SET3).
COMPOSITION
The BCT-HA tube is under vacuum allowing the withdrawal
of 4 ml of blood and contains:
• 2 ml of hyaluronic acid gel (20mg/ml, 40 mg per tube)
in phosphate buffer (Sodium chloride, Dipotassium
hydrogenphosphate, Potassium dihydrogenphosphate,
Potassium chloride and water for injection). Not crosslinked
hyaluronic acid is obtained from bacterial fermentation.
• 3 g of inert cell-selector gel.
• 0.6 ml of anticoagulant (sodium citrate 4%).

CONTRA-INDICATIONS
Absolute contraindications: Do not administer the PRP/HA preparation to patients with ascertained hypersensitivity to one of the components, including hyaluronic acid. Do not use on patients with hereditary or acquired hematologic /coagulation disorders such as  platelet dysfunction syndrome, critical thrombocytopenia, impaired coagulation or patients suffering from uncontrolled severe metabolic or systemic disorders. Do not treat patients who present septicemia or acute infection in the area of the treatment. It is recommended not to use the PRP/HA preparation in patients with partial or total knee prosthesis.
Relative contraindications: It is recommended not to use the PRP/HA preparation in patients with malignancy, particularly with hematologic or bone involvement and metastatic disease, in the previous 5 years, with autoimmune diseases with presence of antibodies and progressive (Hashimoto, rheumatoid arthritis, lupus, etc), with recent fever or illness and with platelet count less than 100’000’000/ml. Taking medication or dietary supplement which alter platelet function, within 3 days, may affect the effectiveness of the treatment. The safety and effectiveness have not been evaluated in children and
in pregnant or lactating women.
It is recommended not to use the PRP/HA preparation in patients with local dermatological diseases at the site of injection.
PRECAUTIONS
Intra-articular injections
Injections of the PRP/HA preparation into the joint cavity must be performed with the same precautions as any other intra-articular injection, and preferably using ultrasound guidance. Joint effusion, if present, must be removed before injecting the PRP/HA preparation. The physician must evaluate the physical aspect of the fluid during the puncture and, if any doubt, appropriate diagnostic testing of the fluid should be undertaken in addition to other form of investigation prior to injecting the PRP/HA preparation. Consequently, the physician must assess whether the intraarticular
injection of PRP/HA should be executed or not.
Following intra-articular injection, the patient must respect a delay of 1h without physical activity after the injection, and avoid prolonged (no more than 10 minutes) standing or walking for the first 12 hours following the intra-articular injection.
Intra-dermal injections
Injections of the PRP/HA preparation must be performed on clean skin (exempt of make-up) using the same precautions as any other intra-dermal injection. Sensitive skin may be pretreated using a local anesthetic cream. This product is intended to be injected in small doses with nappage and filler technique, micro-papula injection technique is not recommended. The patient must avoid UV rays and long exposure to the sun or to the heat (such as saunas) during 1 week after the treatment.
General precautions
The patient must be informed about the general risks
associated with the treatment and the possible adverse
effects. Before use, the physician must consider patient
medical history, especially in terms of coagulation
disorders, and in case of doubt platelet count must
be performed. Where diagnostic certainty cannot be
established, and the conditions listed as contraindicated
cannot be confidentially excluded, the physician must
perform an appropriate benefit to risk assessment to
patients, prior use of the device. The physician must be
familiar with the equipment and with the procedure before
using the kit. The preparation of PRP/HA must be performed
by a physician trained for the equipment and procedure, or
under the supervision of the physician. Injections of PRP/
HA preparation must be performed by a physician trained
and qualified for intra-articular injections and under his
responsibility. Follow the manufacturer’s instructions
when using the centrifuge. Strict aseptic technique must be
followed during phlebotomy and injection. Disinfectants
containing quaternary ammonium salts should not be used
for skin preparation before injection because hyaluronan
can precipitate in their presence. The PRP/HA preparation
must be prepared from fresh blood and must be used
within four hours (extemporaneous use only).
Use appropriate safety precautions to protect yourself
from needles. Do not re-cap the needle after use and
discard directly in the biological hazard container. Throw
away each tube after use, using the method of elimination
for potentially contaminated blood products.
Do not inject intravenously or for any other application
than described in the intended use. Do not use if the
packaging and/or tube are open or damaged. Do not use
the sodium citrate solution or other tube components
alone. Do not use after the expiration date. This product is
for single use only: do not re-use. IGF, EGF, VEGF, FGF) that promote and accelerate healing
of hard and soft tissues. When both HA and PRP are injected
intradermally, this improves firmness and elasticity of the skin
allowing wrinkles prevention and a better appearance.
In order to obtain a longer hydration of the skin, it is
recommended to inject one dose per treatment. Use of device
is restricted to injection in only one area during the same
procedure. The treatment can be repeated according to the
physician decision. See directions for use and precautions for
the manipulation of the device.
— DIRECTIONS FOR USE —
Phase 1: Collecting whole blood
1a. Open the first blister pack, then the second with
care. Write patient ID on BCT-HA tube label to provide
traceability and to ensure autologous use only.
1b. Perform the venous puncture using the necessary
phlebotomy material from Accessory Set and fill the BCTHA
tubes (55) with whole blood. The vacuum within the
tubes will enable automatic collection of the necessary
volume of blood (about 4 ml).
1c. Carefully turn the tubes upside down several times.
1d. Discard withdrawal needle using the adequate method
for elimination of contaminated blood products.
Phase 2: Centrifugation at room temperature
It is essential to correctly balance the centrifuge before
starting it. If necessary, fill the counterbalance tube
(supplied separately) with water until it reaches the same
level as the blood in the BCT-HA tube. Then, insert the
filled tubes into the centrifuge facing each other to balance
the machine.
Adjust the centrifugation values as follows:
• Time: 5 minutes
• Centrifugal force (RCF): 1500 g
(set RPM speed according to the centrifuge
manufacturer’s instructions)
Phase 3: Centrifugation results
After centrifugation, the blood is fractionated: the red blood
cells are trapped under the gel, and cellular elements settle
on the surface of the gel. Hyaluronic acid is positioned over
the plasma.
Phase 4: Homogenization
4a. Hold the tube upside down in a vertical position and
maintain it in this position until the HA detaches from the
tube walls and floats to the top of the plasma layer.
4b. Carefully invert the tube at least 20 times until the
platelets are resuspended.
4c. Roll the tube between fingers in a horizontal position
until all the HA has been removed from tube walls and the
preparation is homogeneous. About 4 ml of PRP/HA mix
will be obtained for each tube.
4d. Use the Transfer Device, from Accessory Set, for
collection of the PRP/HA mix from BCT-HA tube in the
syringe (not supplied) that will be used for injection.
Phase 5: Injection
Inject the final mix at the location required by the physician.
The partial or entire dose can be used according to the
physician decision.
The final PRP/HA mix is composed of PRP which is
diluted in the hyaluronic acid solution. It contains 40mg of
hyaluronic acid in about 4 ml. Platelet content is directly
correlated with the patient’s blood platelet concentration.
Phase 6: Elimination
Discard the withdrawal material, needles and tubes
using the adequate method for elimination of potentially
contaminated blood products.

Intra-articular injections
Hyaluronic acid is a component of synovial joints that
improves elasticity and resistance of synovial fluid to the
shocks. Platelet Rich Plasma contains growth factors
(including PDGF, TGF-ß, IGF, EGF, VEGF, FGF) that
promote and accelerate healing of hard and soft tissues.
When both HA and PRP are injected intra-articularly, pain
is decreased by improvement of joint lubrication and shock
absorption. In order to obtain the most efficient effect,
a longer pain reduction and mobility improvement, it is
recommended to inject one dose per affected joint. Use of
device is restricted to injection in only one joint during the
same procedure. The treatment can be repeated according
to physician decision. See directions for use and precautions
for the manipulation of the device.
The PRP/HA preparation can be used in the following
arthropathies: joints that have had previous surgeries,
congenital conditions leading to abnormalities or
deformities in joints, crystal arthropathies, traumatic
arthropathies, avascular necrosis, diabetic arthropathy,
neuropathic arthropathy.
Intra-dermal injections
Hyaluronic acid is a component of the cellular matrix that
provides hydration and elasticity of the skin. Platelet Rich
Plasma contains growth factors (including PDGF, TGF-ß,

IGF, EGF, VEGF, FGF) that promote and accelerate healing
of hard and soft tissues. When both HA and PRP are injected
intradermally, this improves firmness and elasticity of the skin
allowing wrinkles prevention and a better appearance.
In order to obtain a longer hydration of the skin, it is
recommended to inject one dose per treatment. Use of device
is restricted to injection in only one area during the same
procedure. The treatment can be repeated according to the
physician decision. See directions for use and precautions for
the manipulation of the device.
— DIRECTIONS FOR USE —
Phase 1: Collecting whole blood
1a. Open the first blister pack, then the second with
care. Write patient ID on BCT-HA tube label to provide
traceability and to ensure autologous use only.
1b. Perform the venous puncture using the necessary
phlebotomy material from Accessory Set and fill the BCTHA
tubes (55) with whole blood. The vacuum within the
tubes will enable automatic collection of the necessary
volume of blood (about 4 ml).
1c. Carefully turn the tubes upside down several times.
1d. Discard withdrawal needle using the adequate method
for elimination of contaminated blood products.
Phase 2: Centrifugation at room temperature
It is essential to correctly balance the centrifuge before
starting it. If necessary, fill the counterbalance tube
(supplied separately) with water until it reaches the same
level as the blood in the BCT-HA tube. Then, insert the
filled tubes into the centrifuge facing each other to balance
the machine.
Adjust the centrifugation values as follows:
• Time: 5 minutes
• Centrifugal force (RCF): 1500 g
(set RPM speed according to the centrifuge
manufacturer’s instructions)
Phase 3: Centrifugation results
After centrifugation, the blood is fractionated: the red blood
cells are trapped under the gel, and cellular elements settle
on the surface of the gel. Hyaluronic acid is positioned over
the plasma.
Phase 4: Homogenization
4a. Hold the tube upside down in a vertical position and
maintain it in this position until the HA detaches from the
tube walls and floats to the top of the plasma layer.
4b. Carefully invert the tube at least 20 times until the
platelets are resuspended.
4c. Roll the tube between fingers in a horizontal position
until all the HA has been removed from tube walls and the
preparation is homogeneous. About 4 ml of PRP/HA mix
will be obtained for each tube.
4d. Use the Transfer Device, from Accessory Set, for
collection of the PRP/HA mix from BCT-HA tube in the
syringe (not supplied) that will be used for injection.
Phase 5: Injection
Inject the final mix at the location required by the physician.
The partial or entire dose can be used according to the
physician decision.
The final PRP/HA mix is composed of PRP which is
diluted in the hyaluronic acid solution. It contains 40mg of
hyaluronic acid in about 4 ml. Platelet content is directly
correlated with the patient’s blood platelet concentration.
Phase 6: Elimination
Discard the withdrawal material, needles and tubes
using the adequate method for

POSSIBLE SIDE EFFECTS
Possible side effects of blood collection

Blood collection may cause damage of blood vessels, hematomas, superficial phlebitis, delayed wound healing and / or infections, temporary or permanent nerve damage that may result in pain or numbness and early or late infections. Possible side effects of intra-articular injections When injected intra-articularly, local secondary inflammatory reactions may occur at the site of injection. This may result in temporary pain, feeling of heat, redness and swelling in the joint or area treated with the PRP/HA preparation. Icepacks application in the minutes following the injection, or oral analgesic treatment (acetaminophen) the day following the injection may decrease these inconveniences. The intake of non-steroidal anti-inflammatory drugs (NSAID) must be avoided. Following injection with HA, there have also been occasional reports of hyper-sensitivity, including, rarely, anaphylaxis. The administration of HA was also reported to provoke pronounced inflammatory reactions. Injection may lead to infection if general precautions for injection and asepsis are not respected.
Possible side effects of intra-dermal injections
Following injection with HA, there have also been occasional reports of hyper-sensitivity, including, rarely, anaphylaxis. The administration of HA was also reported to provoke pronounced inflammatory reactions. Reversible inflammatory reactions have been observed 1 or 2 weeks after micro-papular injections Injection may lead to infection if general precautions for injection and asepsis are not respected.
 

STORAGE
Storage of the tubes must be in a range between +5°C to +30°C, keep away from humidity.