Aquisel Tubos Instrucciones-english o5s72
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DIRECTIONS FOR USE TUBES WITH VALVE-STOPPER
AQUISEL® TUBE For venous, arterial and capillary blood collection.
AQUISEL TUBE is an unique system for blood collection. The great difference lies in its special valve-stopper, that allows the insertion or withdrawal of blood samples without uncorking the tube, decreasing the accidental infection from with blood. Moreover the possible spillage due to breaking or uncorking the tube is prevented as well as the aerosol generation.
"AQUISEL TUBE CAN ALWAYS BE CLOSED"
AQUISEL TUBE is formed by a break resistant and transparent TUBE, and an elastic STOPPER, with an special design of cross-cut that allows access to the inside of the tube, making posible that the stopper recovers its initial closed position inmediatly after the insertion or withdrawal of the sample.
Eliminate the unnecessary risks with the system of valve-stopper ICO-002 Rev.: C Dated 09/2006
1
FILLING OF THE AQUISEL® TUBES The sample can be introduced by any of the procedures commonly used:
WITH SYRINGE Once the blood sample has been extracted from the patient, it is recommended that you inmediately remove the syringe tip and make a slight suction with the plunger in order to eliminate any possibility of blood remaining in the tip. This reduces the chance of contaminating the outside of the stopper. Nevertheless, the stopper presents some special corners that can hold small blood quantities to avoid hand . After that, and holding the syringe barrel, we can proceed to the introduction of the syringe tip through the central part of the stopper to transfer the sample, trying to hold the tube as vertical as possible, and to introduce the desired sample into the tube. Before taking the syringe out of the stopper, we recommended you to make another slight suction with the plunger, to eliminate again the blood from the syringe tip, and so on with the rest of tubes to be used with a same patient.
WITH SPECIAL CAP-GALET Specially designed for capillary blood collection, this procedure is very used at paediatrics ( AQUISEL offers theirs tubes 12x55 CAP, suitable for these volumes ). Introduce the bevel parallel to the cross-cut onto stopper
The AQUISEL tubes are prepared to be filled, place the CAPGALET in the first tube to be used according to the position showed at the picture ( introduce the bevel parallel to the stopper cut ). After that and once the area to make the punction has been chosen, previous massage, warming up, etc..., extent a light cape of lubricant hidrofuge steril, one of the market offers, like vaseline, silicone, etc.
Correct position
Incorrect position
Doing the punction and collecting the blood drops that flow sliding by the lubricant area, place the CAP-GALET some mm. under the formation of drops and so collect them. If the drops are kept in the CAP-GALET, do a slight shake of the set, in order to make easier the introduction into the tube. Once the sample has been introduced inside the tube, and removing the CAP-GALET, it would be appropiate to do a slight mixed putting the tube at downside position, in order to do better the mixed blood sample-additive. Within a same patient, use just a CAP-GALET by each tube to be filled.
Filling the tube with CAP-GALET 2
ICO-002 Rev.:C Dated 09/2006
WITH CAPILLARY TUBE The sample can be also introduced using a capillary tube, this procedure is commonly used at paediatrics or in patients who have difficulties for venous or arterial puncture (AQUISEL® offers a wide range of semi-micro tubes with a great usefulness - tubes 12x55 CAP). Doing the puncture at the patient, the capillary tube is introduced through the central part of the stopper and the drops are collected through the free capillary edge. The blood will get into the tube by gravity. When the sample has been taken, the capillary tube is taken out and discarded, it can be repeated using a new capillary tube and a new AQUISEL® tube. Always shake the sample with a slight movement of balancing and rotative movement simultaneously, if the tube has a conical bottom and contains a small sample the shaking action should be more vigorous in order to avoid foam, haemolysis, etc.
WITH OTHERS SYSTEMS The sample can be introduced also with automatic, semi-automatic or manual pipettes, introducing the pipette through the central part of the stopper and transfering the sample into the tube.
TAKING SAMPLES FROM AQUISEL® TUBES The samples can be withdrew from AQUISEL® tubes through the stopper without uncorking, by any of the procedures commonly used ( pipette, capillary tube, automatic or semi-automatic machines, etc. ). The CAP-GALET allows maintaining the AQUISEL® system open. Among others we can use this function for: -
Devices which need an open tubes due to flexible sample taken.
-
Devices which have a double bore, one of aspiration and the other one of level sensor.
-
When we need to deposit or share the sample in other containers.
ICO-002 Rev.: C Dated 09/2006
3
TECNHICAL CHARACTERISTICS OF THE MATERIALS USED The tubes are made of transparent polypropylene, and teatred suitably in order to do not interfere in the analytical valuations. The tubes have a great resistant to breakage and a resistant to the centrifugation. The stoppers are made with special elastic synthetic resin, which is suitable for the functionality of its valve. It allows to keep its functionality at temperatures between -40ºC and +50ºC, a maximum vacuum of 40cm of Hg and pressures of up to 1Kg/cm2 inside the tube. The additives have a differents formats, suitables for each determination which they are assigned. The differents characteristics are described in the specifications of the products.
CHARACTERISTICS OF MANUFACTURE The equipments are automatical, and they have available additives dispensers with high accuracy. The Quality System is according to UNE EN ISO 9001:2000. About the product follows the Norm ISO 6710:1995 about "only use containers for venous blood collection". The products comply with all essential requirements as laid out in Annex I of Real Decreto 1662/2000, transposition to the Spanish Legislation of the Directive 98/79/EC for In Vitro Diagnostic Medical Devices.
MANUFACTURE CHART OF AQUISEL TUBES - CHECKING POINTS
Aquisel s.l. POLYPROPYLENE (PP)
INJECTION
1
SYNTHETIC (SBES)
2
CHEMICAL ELAB ORATION
STOPPER
ADDITIVE
5
4
TUBE
ADDITIVES RAW MATERIAL
1
INJECTION
TUBE
3
LABEL
6
INCOME INSPECTION - AQUISEL s.l. STOPPER
CUT
LABEL
ADDITIVE
7
STOPPER CUT
8 ASSEMBLY TUBE (AUTOMATIC) Tube
Stopper cut
Additive
Label
9
AQUISEL Tube TAPVAL Tube 4
ICO-002 Rev.:C Dated 09/2006
Checking Points
KINDS OF AQUISEL® TUBES ACCORDING TO THE FORMAT They are characterized by their SIZE x DIAMETER ( mm ; approximately ). 100x16
75x16
55x16
80x13
75x13
75x13 V.S.G.
70x12
55x12 CAP
DIAGRAM OF TUBES IN THEIR SIZES (mm) AND CAPACITIES (ml) 100x16
75x16
55x16
80x13
75x13
75x13 Esp.ESR
70x12
55x12 CAP
Stopper maximum Ø
19.7
19.7
19.7
16.7
16.7
16.7
15.4
15.4
Tube top internal Ø
13.5
13.5
13.5
11
11
11
10
10
80.3
75.7
75.7
70.6
56
Lenght: tube + stopper
101.1
77
56.6
Lenght tube without stopper
99.2
75.2
54.6
78.5
74.3
74.3
69
54.5
External Ø of tube
15.2
15.2
15
12.3
12.2
12.2-8.7
11.3
11.3
10
7
5
5
4
1.25ESR
3
2
Volume with stopper(ml) (*)
(*) ISO 6710
ACCORDING TO THE NOMINAL LENGHT OF THE CROSS-CUT VALVE
Tu be D ia m e te r
C ut L e ng ht ( n o m in a l) 10
16
M a x im u m D ia m e t e r o f us e ful (m m )
Use
E x a m p le
9
G e ne r a l
B lu e P ip e tte Tip ( 8 m m )
5
4 .5
T.5 5 x1 6 / V.S .G.
P ip e ttte E .S .R . (4 .5 m m )
5
4
T.5 5 x1 6 E D TA 3 K
M a c hine s H 1 y H 2 Te c hnic o n (* )
8
7
G e ne r a l
Ye llo w P ip e tte Tip . A p p a r a tus w ith a uto m a tic ta k e s a m p le o f H e m a to lo gy.
5
4
T.8 0 x1 3 E D TA 3 K
H 1 ( * ); H 2 ( * ); S T K R ( * * ) ;C O VA S ( * * * )
7
6
G e ne r a l
A p p a ra tus w ith a uto m a tic ta k e s a m p le o f he m a to lo gy. D iffe re nt k ind s o f gla ss p ip e tte s . Ye llo w P ip e tte Tip
13
12
(*) H1 and H2 are registred tradermarks from Tecknicon (**) STKR is a registred tradermark Counter Coulter (***) COVAS is a registred tradermark Roche ICO-002 Rev.: C Dated 09/2006
5
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
K3E - EDTA 3K
ANTICOAGULANT
( Tripotassic salt of ethylenedinitrilotetracetic acid ))
Additive: Solution of EDTA 3K, it is made up of a liquid in watery base with a suitable additives to avoid the evaporation through the plastic resines tubes, in this way avoid the possible solidification at regular storage conditions more than 18 months, holding up the efficiency as the first day. Activity: Anticoagulant which binds calcium ions ( Ca++) of the blood, in order to avoid clot formation. Content: 4,11 - 6,84 micromol of EDTA / blood ml. Intention use: To do recount of blood cells, the cells structures keep stable up to 4 hours after the collection, at ambient temperature. Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position, in order to do better the mixed blood sample with additive. Stability: Guaranteed at less 18 months from their manufacture, depends on the format and volume for it is defined. Storage: Avoid exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBES according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.) Siz e of tube: lenght x diameter (mm)
K 3E
K 3E K 3E
ED TA 3K
ED TA 3K ED TA 3K
S TOPP E R COLOUR
LIQU ID
MAU VE
LIQU ID
800
1.000
55x16
80x13
70x12
55x12 C AP**
FLAT BOTTOM
K IND OF DOS AGE
LIQU ID
800
R EF
blood ml
REF
blood ml
R EF
blood ml
R EF
blood ml
1501103
4
1581104
4
1581105
3
1501106
2
1501113
2
1581114
2,5
1501116
1
1501123
4*
1581124
4*
1501126
0,5
1501133
2*
1581134
2,5*
1681154
3
MAU VE MAU VE
•
* Special for automatic machines of Haematology ( special stopper cut 5mm ). ** Special for Paediatric or small volumes of blood. Reference with stopper no cut
6
ICO-002 Rev.:C Dated 09/2006
•
C ONTEN T / AD D ITIVE
1.000
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
4NC - CITRATE 3 Na 0.106 M (3.8%) (1:4) V.S.G. / E.S.R.
ANTICOAGULANT
Additive: Watery solution of Citrate 3Na 0.106 M (is equal to 3.8% (weight/volume) with Citrate 3Na 5.5 H2O of crystallize and suitable stabilizers). Activity: Anticoagulant operates precipiting the calcium ion Ca++ of the blood, in order to avoid its clotting. Content: Solution of Citrate 3Na 0.106 mol/litre of solution. Tolerance in volume of additive +/10%. The mixing ratio is 1 part citrate solution to 4 parts blood. Intention use: For blood sedimentation rate testing, ESR measurements refer to the Westergren method ( method recommended by The International Committee of Standardization in Haematology – ICSH). Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position, in order to do better the mixed blood sample with additive. If the determination is going to carry out between 4 to 12 hours after the collection, it is recommended to keep the sample cooled (4ºC), and previously to do the determination come back the sample at ambient temperature. At right moment that the determination will carry out, mixing again with at least 12 movements putting the tube at downside position ( or with an automatic mixer ), at this way we guarantee a correct mixing between the additive and the sample. Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volume for it is defined. Storage: Avoid exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table.
Id en tify co lo ur of stop p ers Quan tity o f tub es in each extern al carto n (racks o f 100 u ts.)
1.000
800
800
1.000
S iz e o f tu be : len gh t x d ia m ete r (mm )
55x16 FL AT B OT TOM
75x13
70x12
55x12 C AP **
C ON T E N T / AD D IT IV E
K IN D OF D OS AGE
R EF
b lo o d ml
1501223
2
S T OP P E R C OL OU R
REF
b lo od ml
REF
b loo d ml
REF
b lo o d ml
1,6
1581205
1,2
1501206
1
1581204
4 NC
C ITR ATE 3 N a 0,106 M~3,8% 1:4 E SR
L IQU ID
B LAC K 1581209
1501226 1
0,32
** Special for Paediatric or small volumes of blood. The next references of tubes are recommended to be used together the next pipettes: 1.- Ref. 1501223; 1581204; 1581209; 1581205; 1501206 for AQUISEL pipette A-2 2.- Ref. 1581204 for AQUISEL pipette P-2 3.- Ref. 1561209 for AQUISEL pipette P-3 4.- Ref. 1501226 for AQUISEL pipette P4-MICRO For another trademarks see formats and volumes recommended to them.
ICO-002 Rev.: C Dated 09/2006
7
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
9NC - CITRATE 3 Na 0.106 M (3.8%) (1:9) Clotting Factors
ANTICOAGULANT
Additive: Watery solution of Citrate 3Na 0.106 M (is equal to 3.8% (weight/volume) with Citrate 3Na 5.5 H2O of crystallize and suitable stabilizers). Activity: Anticoagulant operates precipitating the calcium ion (Ca++) of the blood, in order to avoid its clotting. Content: Solution of Citrate 3Na 0.106 mol/litre of solution. Tolerance in volume of additive +/-10%. The mixing ratio is 1 part of citrate to 9 parts of blood. Intention use: For coagulation factors (protombine time, partial protombine time, cephaline time, fibrinogen, antithrombin III, etc…). The blood is stable at ambient temperature only 4 hours after the collection, once mixed the blood with the Citrate is recommended keep at 4ºC. Recomendations for use: It is very important follow the recomendations for the collection, the compression over the vain should be the minimum as possible, it is necessary insert before 30 seconds the sample into the tube to mix with the Citrate, the ratio blood / Citrate shouldn´t exceeded the filling level +/-5%, the mixing must be doing with 3 - 5 movements of balancing, invert and rotative movements simultaneously, avoid overexposure at the vacuum and make foam, etc… Protombine time without separate the blood plasma from the red blood cells: it is necessary do it before 4 hours after the collection, if have to extend its use you will separate the blood plasma from the red blood cells and keep it in refrigerator at 4ºC (recommended no more than 6 hours), for more time it must be freezed. Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volume for it is defined. Storage: Avoid exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
800
800
1.000
Size of tube: lenght x diameter (mm)
80x13
70x12
55x12 CAP**
CONTENT / ADDITIVE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
REF
blood ml
LIQUID
LIGHT BLUE
1581304
4
1581305
2
CITRATE 3 Na 9NC
0,106 M~3,8% 1:9 CLOTTING FACTORS
** Special for Paediatric or small volumes of blood.
8
ICO-002 Rev.:C Dated 09/2006
REF
blood ml
1501306
1
1501326
0,5
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
LH - Lithium Heparin
ANTICOAGULANT
Additive: Watery solution of Lithium Heparin (600.000 IU/litre solution), with suitable stabilizers. Activity: Physiological anticoagulant operates to inhibit the effect of the thrombin, it does not allow to turn the Fibrinogen into Fibrin. Content: 12 - 30 IU of Li Heparin solution /blood ml. Intention use: To do haematological recount or plasma separation inmediately, recommended to clinical biochemistry. Kinds: • With Li Heparin, to be used basically when have to do haematological recount or plasma separation inmediately. • With Li Heparin and separator gel( 1 ), to do the separation between the plasma and the red blood cells, avoiding the crossing of substances which values are much more higher inside the red blood cells than the plasma, these happen with K+, AST, ALT, LDH, etc…At this way moreover avoiding the glucolitique, the plasma keeps stable with a simple centrifugation, so it is not necessary putting into another second tube. Both are not recommended to value TDM, Li+. Don´t use at blood banks ( inhibiting PCR ). Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position, in order to do better the mixed blood sample with additive. When it is neccesary centrifuge; recommended 2200 g. / 15 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of the centrifuge ). Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volume for it is defined. When through the time the Li Heparin is going to dry up, keeps its function but interfere in its activity, is recommended to increase the mixing with 5-8 balancing and rotatives movements.. Storage: Avoid exposure to direct sunlight and it is recommended storage between 4º and 35ºC. ( 1 ) The gel is not consider an additive, after its centrifugation is placed, because of its specific weight, between cells and the plasma, an stable separator barrier is formed. If the tube is going to be carried, it is recommended to leave the tube 1 hour at veritical position, at this way the barrier become stable. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
800
1.000
Size of tube: lenght x diameter (mm)
100x16
80x13
70x12
55x12 CAP**
CONTENT / ADDITIVE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
REF
blood ml
REF
blood ml
REF
blood ml
1561401
10
1581404
4
1581405
2
1501406
1
1501416
1
LH
Li HEPARIN
LIQUID
GREEN
LH
Li HEPARIN WITH SEPARATOR GEL
LIQUID AND GEL
GREEN
** Special for Paediatric or small volumes of blood.
ICO-002 Rev.: C Dated 09/2006
9
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
ANTIGLYCOLITIC ANTICOAGULANT
MONOIODOACETATE Li + Li HEPARIN
Additive: Watery solution of Li Heparin anticoagulant and Monoiodo Acetate Li like antiglycolic, theirs concentrations are 715.000 IU of Li Heparin and 32 gr. of Monoiodoacetate Li / litre of solution. Activity: Like anticoagulant keeps stable the red blood cells, and in the other hand inhibits the glucose consumption by the red blood cells Content: 12 – 17 IU of Li Heparin and 0.5 – 0.8 mg of M.I.A. Li/ blood ml. Intention use: To get the centrifugation of some plasma without haemolysis, in abundance and fastly. With this additive gets stabilizer the glucose together the red blood cells, more than 24 hours without centrifugation, to avoid interferences in the Transaminases (GOT/ASAT – GPT/ALAT) and Creatinine, it is neccesary keep at +4ºC or the highest time as possible. This additive is recommended for urgent collections and general determinations, haematological or biochemical. It is not recommended to value Li+. Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position. Centrifugation is recommended 2200 g. - 3000 g. / 15 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of the centrifuge ). Stability: Guaranteed 12 to 15 months from theirs manufacture, depends on the format and volume for it is defined. When through the time the Li Heparin is dried up, keeps its operate but interfere in its activity, is recommended to increase the mixing with 5-8 balancing and rotative movements. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
800
1.000
Size of tube: lenght x diameter (mm)
80x13
55x12 C AP**
CONTEN T / AD DITIVE
LH
CONTEN T / ADD ITIVE
STOPP E R C OL OU R
R EF
blood ml
R EF
blood ml
LIQU ID
GR EE N
1581604
4
1501606
1
L i HEPAR IN + MON OIOD O AC E TATE Li
** Special for Paediatric or small volumes of blood.
10
ICO-002 Rev.:C Dated 09/2006
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
MONOIODOACETATE Li + CLOTTING ACCELERATOR / GRANULES PS
ANTIGLYCOLITIC
Additive: Mixing of granules PS cover with Monoiodo Acetate Li some of them and the others with clotting accelerator, all of them dried up. Activity: The Monoiodo Acetate Li operates like antiglycolitic for analyses of serum, it inhibits the glucose comsumption by the red blood cells, keep stable more than 24 hours at 4ºC without separate the serum from the red blood cells. The clotting accelerator make operate to turn the Fibrinogen into Fibrin. The granules PS make better the mixing of the additives with the blood and separate the set of red blood cells-clot from the serum. Content: Approx. 0.1 gr. of granules / blood ml. cover with Monoidoacetate Li and clotting accelerator both dried up. Intention use: To obtain serum, allowing to keep the glucose stable more than 24 hours without separate the serum from the red blood cells (clot). Recomendations for use: Recommended to determinations of glucemia, urea and other biochemical determinations with the exception of Lhitium, Al, Yodo,chemotripsine and tripsine. It is neccesary keep at +4ºC after the mixing with the blood, to get the antiglycolitic effect after 24 hours from the collection. Don´t keep more than 2 hours at ambient temperature (20-30ºC) otherwise the dosages of Creatinine, AST/GOT, ALT/GPT are increased, it could be variable depends on the time from the collection of the blood to the separation of the serum and its dosage. It is important put up in doses the suitable blood volume according to the nominal value, otherwise it can be produced a overdosage of antiglycolitics (MIA Li) by blood ml, it can inhibit the enzymatics values in general. After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position in order to improve the mixing with the additive. Centrifugation recommended: 1800 g. / 15 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of centrifugation ). Stability: Guaranteed 15 months from its manufacture. Away from the carton, avoid the exposure to direct sunlight. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. The granules are not consider an additive, which after its centrifugation and because of its specific weight between cells and the plasma, a separator barrier is formed. At this way the barrier become stable ( permeable ) Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
800
Size of tube: lenght x diameter (mm)
100x16
80x13
70x12
CONTENT / ADDITIVE
MONOIODO ACETATE Li + GRANULES ACCELERATOR
CONTENT / ADDITIVE
STOPPER COLOUR
REF
blood ml
REF
blood ml
REF
blood ml
GRANULES
LIGHT GREY
1561521
8
1581524
4
1581525
2
ICO-002 Rev.: C Dated 09/2006
11
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
ANTIGLYCOLITIC ANTICOAGULANT
Sodium FLUORIDE + Potasium OXALATE
Additive: Watery solution with 20 gr. of sodium fluoride and 34,3 gr. of potasium oxalate / litre of solution. Activity: Sodium fluoride operates inhibiting the glucose comsumption by the red blood cells and the postasium oxalate operates like anticoagulant. Content: 1 - 1.4 mg of sodium fluoride and 1.8 – 2.3 mg of potasium oxalate / blood ml. Intention use: To determinate the glucose and other biochemical determinations, and emergencies with the exception of Na and K+ determinations. The glucose keeps stable during 24 hours if the sample will be in the refrigerator at +4ºC. It is not recommended to value K+ and Na+. Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position. Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volume for it is defined. When through the time it is dried up, keeps its function but interfere in its activity, is recommended to increase the mixing with 5-8 balancing and rotative movements. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
800
800
1.000
Size of tube: lenght x diameter (mm)
80x13
70x12
55x12 CAP**
CONTENT / ADDITIVE
FX
Na FLUORIDE+ K OXALATE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
REF
blood ml
REF
blood ml
LIQUID
DARK GREY
1581704
4
1581705
2
1501706
1
** Special for Paediatric or small volumes of blood.
12
ICO-002 Rev.:C Dated 09/2006
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
Z - EMPTY ( without label )
--
Intention use: As a container of any kind of sample, whole blood, plasma, urine, etc… If would need to obtain serum, as it doesn´t have clotting accelerator, the serum will obtain by centrifugation after 2 hours from the collection. Don´t be used with organics solvents, solvents of alcholics types, terpenos, etc… Stability: Guaranteed 5 years from their manufacture. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
Size of tube: lenght x diameter (mm)
100x16
75x16
CONTENT / ADDITIVE
Z
EMPTY WITHOUT LABEL
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
--
WHITE
1561961
10
1.000 55x16 FLAT BOTTOM
REF
blood ml
1581962
7
REF
blood ml
1501963
5
800
800
1.000
80x13
70x12
55x12
REF
blood ml
1581964
5
CAP**
REF
blood ml
REF
blood ml
1581965
3
1501966
2
Volumes according to ISO 6710:1995 ** Special for Paediatric or small volumes of blood.
ICO-002 Rev.: C Dated 09/2006
13
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
Z - TUBE TREATED ( To obtain serum )
For SERUM
Additive: The inside wall of the tube is treated to get a behaviour like a glass tube (unsticking easily the clot of the wall). Activity: The treatment improves the retraction of clot, although this is produced in the time neccesary for a glass tube. Content: Moreover of the treatments of the wall, there are tubes with PS Gel or PS Granules which operate like a separation barrier (serum-clot). Intention use: To obtain serum for clinical biochemistry. Improve the blood clotting, getting the blood is clotting before 10 minutes and the clot is retracted before 60 minutes, obtainning a serum without fibrin after 60 minutes from the collection and 10 minutes after the centrifugation. These are recommended to biochemical determinations, total proteins valuations and division, differents enzymes and isoenzymes, Aldolasa, alfa-Amilasa, LDH, GOT/ASAT, GPT/ALAT, LAP, etc…(have been detected interferences in determinations of Al, Parathormona, Tripsine and Chemotripsine). Valuations of electrolytes: sodium, potasium, magnesium, lithium, calcium, etc…or oligoelements, copper, iron, PBI, etc…; hormones: T-3, T-4; pigments: bilirrubine, lipids, carontens, triglicerides, total cholesterol, HDL, LDL, VLDL, etc…; nitrogenous sustances: urea, creatinine, uric acid, etc… There are three kinds: Only with tube treated. With tube treated and separator gel, after the centrifugation is formed a separation barrier between the red blood cells-clot and the serum, it allows a clean collection and without any contamination of the serum. With tube treated and granules PS, they operate like a separation barrier between the red blood cellsclot and the serum. Recomendations for use: After inserting the sample in the tube ( following the recomendations to fill ), do 2 -3 slight mixed putting the tube at downside position. Centrifuge when the clotting have been done ( aproximately 2 hours ); recommended 1800 g. / 10 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of centrifugation ). Once the sample is centrifugated and keep at 4ºC, it can be kept for 48 hours, although some values could not stay stable. If you want to extend the conservation, separate the serum and keep at -20ºC. Stability: The kind with gel is guaranteed 2 years, the others kinds 3 years from their manufacture In all kinds the treatment lose its stability when are put to above 50ºC. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Note: The gel and the granules are not consider an additive. After its centrifugation the gel is placed, because of its specific weight, between cells and the plasma, a separator barrier is formed. If the tube is going to be carried, it is recommended to leave the tube 1 hour at veritical position, at this way the barrier become stable. When there are granules happen the same but the separator barrier is permeable.
Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
800
800
1.000
Size of tube: lenght x diameter (mm)
100x16
75x16
80x13
70x12
55x12
CONTENT / ADDITIVE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
REF
blood ml
REF
blood ml
REF
blood ml
Z
EMPTY WITH LABEL
SPRAY
WHITE
1561971
10
1581974
5
1581975
3
1501976
2
Z
SEPARATOR GEL FOR SERUM
GEL
WHITE
1561981
9
1581984
4
1501986
1.5
Z
GRANULES PS FOR SERUM
GRANULES
WHITE
1561951
9
1581954
4
1501956
1.5
REF
1581952
blood ml
6
** Special for Paediatric or small volumes of blood. 14
CAP**
ICO-002 Rev.:C Dated 09/2006
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
Z - CLOTTING ACCELERATOR ( To obtain serum )
CLOTTING ACCELERATOR
Additive: The clotting accelerator used has protein nature, it is made up by an enzyme very stable at ambient temperature. Activity: Make operate to turn the Fibrinogen into Fibrin, reducing the clotting time. Content: Clotting accelerator, or depends on the formats contain PS Gel or PS Granules. Intention use: To obtain serum for clinical biochemistry. Improve the blood clotting, getting the blood begin the process of clotting before 15 minutes and the clot is retracted before 30 minutes, obtainning a serum without fibrin after 30 minutes from the collection and 10 minutes after the centrifugation. These are recommended to biochemical determinations, total proteins valuations and division, differents enzymes and isoenzymes, Aldolasa, alfa-Amilasa, LDH, GOT/ASAT, GPT/ALAT, LAP, etc…(have been detected interferences in determinations of Al, Parathormona, Tripsine and Chemotripsine). Valuations of electrolytes: sodium, potasium, mangesium, lithium, calcium, etc…or oligoelements, copper, iron, PBI, etc…; hormones: T-3, T-4; pigments: bilirrubine, lipids, carontens, triglicerides, total cholesterol, HDL, LDL, VLDL, etc…;nitrogenous sustances: urea, creatinine, uric acid, etic… There are three kinds: Only with clotting accelerator, getting to go quick at the mixing. With liquid clotting accelerator and separator gel, moreover of reducing the clotting time, the gel forms a separation barrier between the clot and the serum, it allows obtain the serum of a clean way and without any contamination. With clotting accelerator dried up and PS granules, moreover of reducing the clotting time, the granules have two functions, one make better the mixing of the clotting accelerator with the blood and the other one operates like a separation barrier between the red blood cells-clot and the serum. Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 2 -3 slight mixed putting the tube at downside position. After 30 minutes centrifuge; recommended 1800 g. / 10 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of centrifugation ). Once the sample is centrifugated and keep at 4ºC, it can be kept for 48 hours, although some values could not stay stable. If you want to extend the conservation, separate the serum and keep at -20ºC. Stability: The kind of cloting accelerator with gel is guaranteed 15 months, the others kinds 3 years from theirs manufacture. In all kinds the accelerator could lose its stability when are put to above 50ºC. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Note: The gel and the granules are not consider an additive. After its centrifugation the gel is placed, because of its specific weight, between cells and the plasma, a separator barrier is formed. If the tube is going to be carried, it is recommended to leave the tube 1 hour at veritical position, at this way the barrier become stable. When there are granules happen the same but the separator barrier is permeable.
Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
800
800
1.000
Size of tube: lenght x diameter (mm)
100x16
75x16
80x13
70x12
55x12 CAP**
CONTENT / ADDITIVE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
Z
CLOTTING ACCELERATOR
LIQUID
RED
Z
CLOTTING ACCELERATOR AND SEPARATOR GEL
LIQUID AND GEL
RED
1561811
9
Z
CLOTTING ACCELERATOR AND GRANULES PS FOR SERUM
GRANULES
RED
1561941
9
REF
1581942
blood ml
6
REF
blood ml
1581814
4
1581944
4
REF
1581945
blood ml
3
REF
blood ml
1501806
2
1501816
1.5
1501946
1.5
** Special for Paediatric or small volumes of blood.
ICO-002 Rev.: C Dated 09/2006
15
PRODUCT PRESENTATION The AQUISEL® tubes are presented ready to be used with the suitable additive for each function and volume. They are placed in racks of 100 pcs., the racks are made in EPS, they are designed to facility their handling. Every 50 pcs. are cover with a lid that protect the stopper outside from possible contamination ( particles,... ) which could be produced during the storage and transport. Once the sample has been introduced, the tubes can be carry with the same racks, free, by pneumatic means, by post, etc...
LABEL INFORMATION ®
TUBE LABEL
LABEL OF SHIPPING CARTON
K3E / EDTA 3K IVD
2005-09
123456
1501226 000000 AAAA-MM LOT
REF
0,5 ml
K3E / EDTA 3K
IVD
EAN-128 BAR CODE IVD
Code alphanumeric / additive In vitro diagnostic medical device ( D. 98/79/CE)
Temperature limitation recommmended for storage
CE mark ( D. 98/79/CE)
Manufacturer
2
Do not reuse ( EN-980 )
!
Consult accompanying documents ( EN-980 )
Fagile - handly with care
Expiry date ( EN-980 ) REF LOT
!
Reference to request the product ( EN-980 ) Manufacture Lot ( 6 digits - the two first: the last two number of manufacture year and the rest four: a correlative number of manufacture ) / ( EN-980 )
Place the box as show the arrows
Keep dry
Level filled - guiding line to fill the tube 2.5 ml
Keep away from direct sunlight
Nominal volume - volume of blood to be introduced
PRESENTATION OF SHIPPING CARTONS
16
TUBE SIZE (mm.)
TUBES PER BOX (Uts.)
BOX DIMENSIONS (cm.) (L x D x W)
MAX. WEIGHT (Kg.)
100x16
600
47x23x34
4,3
75x16
800
47x23x36
4,3
55x16
1000
47x23x34
4
80x13
800
39x22x36
3,5
70x12
800
36x21x34
3
55x12
1000
36x21x34
3,5
ICO-002 Rev.:C Dated 09/2006
GENERAL INSTRUCTIONS FOR AQUISEL® TUBE STORAGE Storage temperature recommended: 4º - 35ºC (40º - 115ºF ) Avoid exposure to direct sunlight. If the maximum temperature recommended is exceeded, it could change the quality of the tubes ( for example: dry up the additives, discolour, ... ) The tubes with sample allow a storage up to -20ºC. PRECAUTIONS / CAUTIONS 1.- Not use tubes if foreing matter is present, or if could see the tube would have lost its phisical wellbeing. 2.- Filling the tubes according to the nominal volume shown in the label, if the ratio sample-additive is not kept this could become a bad preservation of the sample or change the results. 3.- Not shake the tubes vigorously it could produce haemolysis and change the analysis results. 4.- An insufficient mix of the sample with the additive it could become a bad preservation of the samples and because of this over the determinations. 5.- The almost additives are colourless and odourless. Don´t use the tubes where the additive has changed its colour ( exception: teatred tubes for serum and with clotting accelerator, through the time the teatred and the clotting accelerator tend towards yellow, but the product is not affected ) 6.- Not use tubes after expiration date CAUTIONS a.- Handle all biological samples and blood collection ries ( lancets, needles, luer adapters, ... ) according to the policies and procedures of your facility ( use gloves, avoid to breth aerosol,.. ) b.- Obtain appropiate medical attention in the case of any exposure to biological samples, since they may transmit HIV , hepatitis B and C or other infectious disease. c.- Additional manipulation of sharps increases the potencial for needle stick injury. d.- Wear gloves reduce the infections risk.
CENTRIFUGATION For the centrifugation you can use any centrifuge. Nevertheless, the diameter and the addapter height should be taken on, in order to avoid the unplugging of the tubes during the centrifugation. The correct way of placing the tubes inside the addapter of the centrifuge should be checked. Within kind of tube and according to the determinations to be done, the guiding recommendations are shown. 2 The general recommendations for the centrifugation are: From 1500g to 3000 g ( g = 0.00001118 x r x V ) Recommending to centrifuge with cooled centrifugates ( temperature: 15º - 24ºC ). When there is an element which function is doing a separator barrier ( Gel, PS granules ), in centrifuges with swing out rotor the separator barrier will be better defined than the centrifuges with angles rotor. Not recommended a second centrifugation. J.P. SELECTA s.a. has special addapters to centrifuge AQUISEL ® tubes with models MIXTASEL, CENTRONIC, MEDITRONIC y MEDIFRIGER. DISPOSAL The general hygiene guidelines and legal regulations for the proper disposal and infectuous material should be considered and followed ( laboratories / hospitals ).
ICO-002 Rev.: C Dated 09/2006
17
PRODUCTS TABLE AQUISEL® tubes with valve-stopper Number of tubes in the shipping boxes (racks of 100uts. )
600
800
1.000
800
800
1.000
Nominal size of the tube: L x diameter ( mm )
100x16
75x16
55x16 FLAT BOTTOM
80x13
70x12
55x12 CAP
K3E
K3E
4 NC
STOPPER COLOUR
KIND OF DOSAGE
CONTENT / ADDITIVE
EDTA3K
LIQUID
EDTA3K
blood ml
REF
blood ml
REF
blood ml
REF
blood ml
1501103
4
1581104
4
1581105
3
1501106
2
1501113
2
1581114
2,5
1501116
1
1501123
4*
1581124
4*
1501126
0,5
1501133
2*
1581134
2,5*
1501223
2
1501206
1
MAUVE
LIQUID
BLACK
1581204
º
1581209
CITRATE 3 Na 0,106 M~3,8% 1:9 CLOTTING FACTORS
LIQUID
LH
Li HEPARIN
LIQUID
GREEN
LH
Li HEPARIN WITH SEPARATOR GEL
LIQUID AND GEL
GREEN
LH
Li HEPARIN + MONOIODO ACETATE Li
LIQUID
GREEN
MONOIODO ACETATE Li + GRANULES ACCELERATOR
GRANULES
LIGHT GREY
FX
Na FLUORIDE + K OXALATE
LIQUID
DARK GREY
Z
EMPTY WITHOUT LABEL
Z
EMPTY WITH LABEL FOR SERUM
Z
9NC
REF
blood ml
REF
MAUVE
LIQUID
CITRATE 3 Na 0,106 M~3,8% 1:4 VSG/ESR
blood ml
REF
LIGHT BLUE 1561401
1561521
10
•
1
1581304
4
1581404
8
5
1501226
1581305
1581405
—
0,32
1501306
1
1501326
0,5
1501406
1
1501416
1
1501606
1
2
2
1581604
4
1581524
4
1581525
2
1581704
4
1581705
2
1501706
1
1581964
5
1581965
4
1501966
2,5
1581975
4
1501976
2,5
10
SPRAYED
WHITE
1561971
10
1581974
5
SEPARATOR GEL FOR SERUM
GEL
WHITE
1561981
9
1581984
4
1501986
2
Z
GRANULES PS FOR SERUM
GRANULES
WHITE
1561951
9
1581954
4
1501956
2
Z
CLOTTING ACCELERATOR
LIQUID
RED
1501806
2,5
Z
CLOTTING ACCELERATOR AND SEPARATOR GEL
LIQUID AND GEL
RED
1561811
9
1501816
2
Z
CLOTTING ACCELERATOR AND GRANULES PS FOR SERUM
GRANULES
RED
1561941
9
1501946
2
1581942
1501963
1,2
1561961
1581952
7
4
1581205
WHITE
Box Dimensions
1581962
1,6
6
6
1581814
4
1581944
4
1581945
3
Lenght (cm)
47
47
47
39
36
36
Width (cm)
23
23
23
22
21
21
Height (cm)
34
34
34
36
34
34
Weight (Kg)
4,3
4,3
4,0
3,5
3,0
3,5
* Special for Haematology automatic machines ( special cut of the stopper 5 mm ) Tube 75x13 for AQUISEL pipette P2. — Special tube for AQUISEL pipette P4 MICRO • Special tube for AQUISEL pipette P3
º
AQUISEL® tubes - stopper without valve CONTENT / ADDITIVE
K3E
18
EDTA 3K
KIND OF DOSAGE
LIQUID
STOPPER COLOUR
MAUVE
Nº OF TUBES PER BOX
REF
blood ml
SIZE TUBE Length x Ø mm.
BOX SIZE cm. L/W/H
WEIGHT Kg
800
1681154
3
80 x 13
39 / 22 / 36
3
ICO-002 Rev.:C Dated 09/2006
Directions for use tubes with valve-stopper AQUISEL : to subsitute ICO-002 Rev: B Dated : 10/2003 for ICO-002 Rev: C Dated 09/2006
Manufacturer :
Aquisel s.l. Crta.Nacional II, km 585,1 08630 ABRERA (Barcelona) Spain
Dealer:
J.P.Selecta s.a. Crta.Nacional II, km 585,1 08630 ABRERA (Barcelona) Spain Tf.: (34) 93 770 08 77 - Fax (34) 93 770 23 62 Web: www.jpselecta.es - @mail: [email protected]
AQUISEL® TUBE Dealer:
ICO-002 Rev.: C Dated 09/2006
19
AQUISEL® TUBE For venous, arterial and capillary blood collection.
AQUISEL TUBE is an unique system for blood collection. The great difference lies in its special valve-stopper, that allows the insertion or withdrawal of blood samples without uncorking the tube, decreasing the accidental infection from with blood. Moreover the possible spillage due to breaking or uncorking the tube is prevented as well as the aerosol generation.
"AQUISEL TUBE CAN ALWAYS BE CLOSED"
AQUISEL TUBE is formed by a break resistant and transparent TUBE, and an elastic STOPPER, with an special design of cross-cut that allows access to the inside of the tube, making posible that the stopper recovers its initial closed position inmediatly after the insertion or withdrawal of the sample.
Eliminate the unnecessary risks with the system of valve-stopper ICO-002 Rev.: C Dated 09/2006
1
FILLING OF THE AQUISEL® TUBES The sample can be introduced by any of the procedures commonly used:
WITH SYRINGE Once the blood sample has been extracted from the patient, it is recommended that you inmediately remove the syringe tip and make a slight suction with the plunger in order to eliminate any possibility of blood remaining in the tip. This reduces the chance of contaminating the outside of the stopper. Nevertheless, the stopper presents some special corners that can hold small blood quantities to avoid hand . After that, and holding the syringe barrel, we can proceed to the introduction of the syringe tip through the central part of the stopper to transfer the sample, trying to hold the tube as vertical as possible, and to introduce the desired sample into the tube. Before taking the syringe out of the stopper, we recommended you to make another slight suction with the plunger, to eliminate again the blood from the syringe tip, and so on with the rest of tubes to be used with a same patient.
WITH SPECIAL CAP-GALET Specially designed for capillary blood collection, this procedure is very used at paediatrics ( AQUISEL offers theirs tubes 12x55 CAP, suitable for these volumes ). Introduce the bevel parallel to the cross-cut onto stopper
The AQUISEL tubes are prepared to be filled, place the CAPGALET in the first tube to be used according to the position showed at the picture ( introduce the bevel parallel to the stopper cut ). After that and once the area to make the punction has been chosen, previous massage, warming up, etc..., extent a light cape of lubricant hidrofuge steril, one of the market offers, like vaseline, silicone, etc.
Correct position
Incorrect position
Doing the punction and collecting the blood drops that flow sliding by the lubricant area, place the CAP-GALET some mm. under the formation of drops and so collect them. If the drops are kept in the CAP-GALET, do a slight shake of the set, in order to make easier the introduction into the tube. Once the sample has been introduced inside the tube, and removing the CAP-GALET, it would be appropiate to do a slight mixed putting the tube at downside position, in order to do better the mixed blood sample-additive. Within a same patient, use just a CAP-GALET by each tube to be filled.
Filling the tube with CAP-GALET 2
ICO-002 Rev.:C Dated 09/2006
WITH CAPILLARY TUBE The sample can be also introduced using a capillary tube, this procedure is commonly used at paediatrics or in patients who have difficulties for venous or arterial puncture (AQUISEL® offers a wide range of semi-micro tubes with a great usefulness - tubes 12x55 CAP). Doing the puncture at the patient, the capillary tube is introduced through the central part of the stopper and the drops are collected through the free capillary edge. The blood will get into the tube by gravity. When the sample has been taken, the capillary tube is taken out and discarded, it can be repeated using a new capillary tube and a new AQUISEL® tube. Always shake the sample with a slight movement of balancing and rotative movement simultaneously, if the tube has a conical bottom and contains a small sample the shaking action should be more vigorous in order to avoid foam, haemolysis, etc.
WITH OTHERS SYSTEMS The sample can be introduced also with automatic, semi-automatic or manual pipettes, introducing the pipette through the central part of the stopper and transfering the sample into the tube.
TAKING SAMPLES FROM AQUISEL® TUBES The samples can be withdrew from AQUISEL® tubes through the stopper without uncorking, by any of the procedures commonly used ( pipette, capillary tube, automatic or semi-automatic machines, etc. ). The CAP-GALET allows maintaining the AQUISEL® system open. Among others we can use this function for: -
Devices which need an open tubes due to flexible sample taken.
-
Devices which have a double bore, one of aspiration and the other one of level sensor.
-
When we need to deposit or share the sample in other containers.
ICO-002 Rev.: C Dated 09/2006
3
TECNHICAL CHARACTERISTICS OF THE MATERIALS USED The tubes are made of transparent polypropylene, and teatred suitably in order to do not interfere in the analytical valuations. The tubes have a great resistant to breakage and a resistant to the centrifugation. The stoppers are made with special elastic synthetic resin, which is suitable for the functionality of its valve. It allows to keep its functionality at temperatures between -40ºC and +50ºC, a maximum vacuum of 40cm of Hg and pressures of up to 1Kg/cm2 inside the tube. The additives have a differents formats, suitables for each determination which they are assigned. The differents characteristics are described in the specifications of the products.
CHARACTERISTICS OF MANUFACTURE The equipments are automatical, and they have available additives dispensers with high accuracy. The Quality System is according to UNE EN ISO 9001:2000. About the product follows the Norm ISO 6710:1995 about "only use containers for venous blood collection". The products comply with all essential requirements as laid out in Annex I of Real Decreto 1662/2000, transposition to the Spanish Legislation of the Directive 98/79/EC for In Vitro Diagnostic Medical Devices.
MANUFACTURE CHART OF AQUISEL TUBES - CHECKING POINTS
Aquisel s.l. POLYPROPYLENE (PP)
INJECTION
1
SYNTHETIC (SBES)
2
CHEMICAL ELAB ORATION
STOPPER
ADDITIVE
5
4
TUBE
ADDITIVES RAW MATERIAL
1
INJECTION
TUBE
3
LABEL
6
INCOME INSPECTION - AQUISEL s.l. STOPPER
CUT
LABEL
ADDITIVE
7
STOPPER CUT
8 ASSEMBLY TUBE (AUTOMATIC) Tube
Stopper cut
Additive
Label
9
AQUISEL Tube TAPVAL Tube 4
ICO-002 Rev.:C Dated 09/2006
Checking Points
KINDS OF AQUISEL® TUBES ACCORDING TO THE FORMAT They are characterized by their SIZE x DIAMETER ( mm ; approximately ). 100x16
75x16
55x16
80x13
75x13
75x13 V.S.G.
70x12
55x12 CAP
DIAGRAM OF TUBES IN THEIR SIZES (mm) AND CAPACITIES (ml) 100x16
75x16
55x16
80x13
75x13
75x13 Esp.ESR
70x12
55x12 CAP
Stopper maximum Ø
19.7
19.7
19.7
16.7
16.7
16.7
15.4
15.4
Tube top internal Ø
13.5
13.5
13.5
11
11
11
10
10
80.3
75.7
75.7
70.6
56
Lenght: tube + stopper
101.1
77
56.6
Lenght tube without stopper
99.2
75.2
54.6
78.5
74.3
74.3
69
54.5
External Ø of tube
15.2
15.2
15
12.3
12.2
12.2-8.7
11.3
11.3
10
7
5
5
4
1.25ESR
3
2
Volume with stopper(ml) (*)
(*) ISO 6710
ACCORDING TO THE NOMINAL LENGHT OF THE CROSS-CUT VALVE
Tu be D ia m e te r
C ut L e ng ht ( n o m in a l) 10
16
M a x im u m D ia m e t e r o f us e ful (m m )
Use
E x a m p le
9
G e ne r a l
B lu e P ip e tte Tip ( 8 m m )
5
4 .5
T.5 5 x1 6 / V.S .G.
P ip e ttte E .S .R . (4 .5 m m )
5
4
T.5 5 x1 6 E D TA 3 K
M a c hine s H 1 y H 2 Te c hnic o n (* )
8
7
G e ne r a l
Ye llo w P ip e tte Tip . A p p a r a tus w ith a uto m a tic ta k e s a m p le o f H e m a to lo gy.
5
4
T.8 0 x1 3 E D TA 3 K
H 1 ( * ); H 2 ( * ); S T K R ( * * ) ;C O VA S ( * * * )
7
6
G e ne r a l
A p p a ra tus w ith a uto m a tic ta k e s a m p le o f he m a to lo gy. D iffe re nt k ind s o f gla ss p ip e tte s . Ye llo w P ip e tte Tip
13
12
(*) H1 and H2 are registred tradermarks from Tecknicon (**) STKR is a registred tradermark Counter Coulter (***) COVAS is a registred tradermark Roche ICO-002 Rev.: C Dated 09/2006
5
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
K3E - EDTA 3K
ANTICOAGULANT
( Tripotassic salt of ethylenedinitrilotetracetic acid ))
Additive: Solution of EDTA 3K, it is made up of a liquid in watery base with a suitable additives to avoid the evaporation through the plastic resines tubes, in this way avoid the possible solidification at regular storage conditions more than 18 months, holding up the efficiency as the first day. Activity: Anticoagulant which binds calcium ions ( Ca++) of the blood, in order to avoid clot formation. Content: 4,11 - 6,84 micromol of EDTA / blood ml. Intention use: To do recount of blood cells, the cells structures keep stable up to 4 hours after the collection, at ambient temperature. Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position, in order to do better the mixed blood sample with additive. Stability: Guaranteed at less 18 months from their manufacture, depends on the format and volume for it is defined. Storage: Avoid exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBES according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.) Siz e of tube: lenght x diameter (mm)
K 3E
K 3E K 3E
ED TA 3K
ED TA 3K ED TA 3K
S TOPP E R COLOUR
LIQU ID
MAU VE
LIQU ID
800
1.000
55x16
80x13
70x12
55x12 C AP**
FLAT BOTTOM
K IND OF DOS AGE
LIQU ID
800
R EF
blood ml
REF
blood ml
R EF
blood ml
R EF
blood ml
1501103
4
1581104
4
1581105
3
1501106
2
1501113
2
1581114
2,5
1501116
1
1501123
4*
1581124
4*
1501126
0,5
1501133
2*
1581134
2,5*
1681154
3
MAU VE MAU VE
•
* Special for automatic machines of Haematology ( special stopper cut 5mm ). ** Special for Paediatric or small volumes of blood. Reference with stopper no cut
6
ICO-002 Rev.:C Dated 09/2006
•
C ONTEN T / AD D ITIVE
1.000
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
4NC - CITRATE 3 Na 0.106 M (3.8%) (1:4) V.S.G. / E.S.R.
ANTICOAGULANT
Additive: Watery solution of Citrate 3Na 0.106 M (is equal to 3.8% (weight/volume) with Citrate 3Na 5.5 H2O of crystallize and suitable stabilizers). Activity: Anticoagulant operates precipiting the calcium ion Ca++ of the blood, in order to avoid its clotting. Content: Solution of Citrate 3Na 0.106 mol/litre of solution. Tolerance in volume of additive +/10%. The mixing ratio is 1 part citrate solution to 4 parts blood. Intention use: For blood sedimentation rate testing, ESR measurements refer to the Westergren method ( method recommended by The International Committee of Standardization in Haematology – ICSH). Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position, in order to do better the mixed blood sample with additive. If the determination is going to carry out between 4 to 12 hours after the collection, it is recommended to keep the sample cooled (4ºC), and previously to do the determination come back the sample at ambient temperature. At right moment that the determination will carry out, mixing again with at least 12 movements putting the tube at downside position ( or with an automatic mixer ), at this way we guarantee a correct mixing between the additive and the sample. Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volume for it is defined. Storage: Avoid exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table.
Id en tify co lo ur of stop p ers Quan tity o f tub es in each extern al carto n (racks o f 100 u ts.)
1.000
800
800
1.000
S iz e o f tu be : len gh t x d ia m ete r (mm )
55x16 FL AT B OT TOM
75x13
70x12
55x12 C AP **
C ON T E N T / AD D IT IV E
K IN D OF D OS AGE
R EF
b lo o d ml
1501223
2
S T OP P E R C OL OU R
REF
b lo od ml
REF
b loo d ml
REF
b lo o d ml
1,6
1581205
1,2
1501206
1
1581204
4 NC
C ITR ATE 3 N a 0,106 M~3,8% 1:4 E SR
L IQU ID
B LAC K 1581209
1501226 1
0,32
** Special for Paediatric or small volumes of blood. The next references of tubes are recommended to be used together the next pipettes: 1.- Ref. 1501223; 1581204; 1581209; 1581205; 1501206 for AQUISEL pipette A-2 2.- Ref. 1581204 for AQUISEL pipette P-2 3.- Ref. 1561209 for AQUISEL pipette P-3 4.- Ref. 1501226 for AQUISEL pipette P4-MICRO For another trademarks see formats and volumes recommended to them.
ICO-002 Rev.: C Dated 09/2006
7
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
9NC - CITRATE 3 Na 0.106 M (3.8%) (1:9) Clotting Factors
ANTICOAGULANT
Additive: Watery solution of Citrate 3Na 0.106 M (is equal to 3.8% (weight/volume) with Citrate 3Na 5.5 H2O of crystallize and suitable stabilizers). Activity: Anticoagulant operates precipitating the calcium ion (Ca++) of the blood, in order to avoid its clotting. Content: Solution of Citrate 3Na 0.106 mol/litre of solution. Tolerance in volume of additive +/-10%. The mixing ratio is 1 part of citrate to 9 parts of blood. Intention use: For coagulation factors (protombine time, partial protombine time, cephaline time, fibrinogen, antithrombin III, etc…). The blood is stable at ambient temperature only 4 hours after the collection, once mixed the blood with the Citrate is recommended keep at 4ºC. Recomendations for use: It is very important follow the recomendations for the collection, the compression over the vain should be the minimum as possible, it is necessary insert before 30 seconds the sample into the tube to mix with the Citrate, the ratio blood / Citrate shouldn´t exceeded the filling level +/-5%, the mixing must be doing with 3 - 5 movements of balancing, invert and rotative movements simultaneously, avoid overexposure at the vacuum and make foam, etc… Protombine time without separate the blood plasma from the red blood cells: it is necessary do it before 4 hours after the collection, if have to extend its use you will separate the blood plasma from the red blood cells and keep it in refrigerator at 4ºC (recommended no more than 6 hours), for more time it must be freezed. Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volume for it is defined. Storage: Avoid exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
800
800
1.000
Size of tube: lenght x diameter (mm)
80x13
70x12
55x12 CAP**
CONTENT / ADDITIVE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
REF
blood ml
LIQUID
LIGHT BLUE
1581304
4
1581305
2
CITRATE 3 Na 9NC
0,106 M~3,8% 1:9 CLOTTING FACTORS
** Special for Paediatric or small volumes of blood.
8
ICO-002 Rev.:C Dated 09/2006
REF
blood ml
1501306
1
1501326
0,5
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
LH - Lithium Heparin
ANTICOAGULANT
Additive: Watery solution of Lithium Heparin (600.000 IU/litre solution), with suitable stabilizers. Activity: Physiological anticoagulant operates to inhibit the effect of the thrombin, it does not allow to turn the Fibrinogen into Fibrin. Content: 12 - 30 IU of Li Heparin solution /blood ml. Intention use: To do haematological recount or plasma separation inmediately, recommended to clinical biochemistry. Kinds: • With Li Heparin, to be used basically when have to do haematological recount or plasma separation inmediately. • With Li Heparin and separator gel( 1 ), to do the separation between the plasma and the red blood cells, avoiding the crossing of substances which values are much more higher inside the red blood cells than the plasma, these happen with K+, AST, ALT, LDH, etc…At this way moreover avoiding the glucolitique, the plasma keeps stable with a simple centrifugation, so it is not necessary putting into another second tube. Both are not recommended to value TDM, Li+. Don´t use at blood banks ( inhibiting PCR ). Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position, in order to do better the mixed blood sample with additive. When it is neccesary centrifuge; recommended 2200 g. / 15 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of the centrifuge ). Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volume for it is defined. When through the time the Li Heparin is going to dry up, keeps its function but interfere in its activity, is recommended to increase the mixing with 5-8 balancing and rotatives movements.. Storage: Avoid exposure to direct sunlight and it is recommended storage between 4º and 35ºC. ( 1 ) The gel is not consider an additive, after its centrifugation is placed, because of its specific weight, between cells and the plasma, an stable separator barrier is formed. If the tube is going to be carried, it is recommended to leave the tube 1 hour at veritical position, at this way the barrier become stable. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
800
1.000
Size of tube: lenght x diameter (mm)
100x16
80x13
70x12
55x12 CAP**
CONTENT / ADDITIVE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
REF
blood ml
REF
blood ml
REF
blood ml
1561401
10
1581404
4
1581405
2
1501406
1
1501416
1
LH
Li HEPARIN
LIQUID
GREEN
LH
Li HEPARIN WITH SEPARATOR GEL
LIQUID AND GEL
GREEN
** Special for Paediatric or small volumes of blood.
ICO-002 Rev.: C Dated 09/2006
9
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
ANTIGLYCOLITIC ANTICOAGULANT
MONOIODOACETATE Li + Li HEPARIN
Additive: Watery solution of Li Heparin anticoagulant and Monoiodo Acetate Li like antiglycolic, theirs concentrations are 715.000 IU of Li Heparin and 32 gr. of Monoiodoacetate Li / litre of solution. Activity: Like anticoagulant keeps stable the red blood cells, and in the other hand inhibits the glucose consumption by the red blood cells Content: 12 – 17 IU of Li Heparin and 0.5 – 0.8 mg of M.I.A. Li/ blood ml. Intention use: To get the centrifugation of some plasma without haemolysis, in abundance and fastly. With this additive gets stabilizer the glucose together the red blood cells, more than 24 hours without centrifugation, to avoid interferences in the Transaminases (GOT/ASAT – GPT/ALAT) and Creatinine, it is neccesary keep at +4ºC or the highest time as possible. This additive is recommended for urgent collections and general determinations, haematological or biochemical. It is not recommended to value Li+. Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position. Centrifugation is recommended 2200 g. - 3000 g. / 15 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of the centrifuge ). Stability: Guaranteed 12 to 15 months from theirs manufacture, depends on the format and volume for it is defined. When through the time the Li Heparin is dried up, keeps its operate but interfere in its activity, is recommended to increase the mixing with 5-8 balancing and rotative movements. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
800
1.000
Size of tube: lenght x diameter (mm)
80x13
55x12 C AP**
CONTEN T / AD DITIVE
LH
CONTEN T / ADD ITIVE
STOPP E R C OL OU R
R EF
blood ml
R EF
blood ml
LIQU ID
GR EE N
1581604
4
1501606
1
L i HEPAR IN + MON OIOD O AC E TATE Li
** Special for Paediatric or small volumes of blood.
10
ICO-002 Rev.:C Dated 09/2006
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
MONOIODOACETATE Li + CLOTTING ACCELERATOR / GRANULES PS
ANTIGLYCOLITIC
Additive: Mixing of granules PS cover with Monoiodo Acetate Li some of them and the others with clotting accelerator, all of them dried up. Activity: The Monoiodo Acetate Li operates like antiglycolitic for analyses of serum, it inhibits the glucose comsumption by the red blood cells, keep stable more than 24 hours at 4ºC without separate the serum from the red blood cells. The clotting accelerator make operate to turn the Fibrinogen into Fibrin. The granules PS make better the mixing of the additives with the blood and separate the set of red blood cells-clot from the serum. Content: Approx. 0.1 gr. of granules / blood ml. cover with Monoidoacetate Li and clotting accelerator both dried up. Intention use: To obtain serum, allowing to keep the glucose stable more than 24 hours without separate the serum from the red blood cells (clot). Recomendations for use: Recommended to determinations of glucemia, urea and other biochemical determinations with the exception of Lhitium, Al, Yodo,chemotripsine and tripsine. It is neccesary keep at +4ºC after the mixing with the blood, to get the antiglycolitic effect after 24 hours from the collection. Don´t keep more than 2 hours at ambient temperature (20-30ºC) otherwise the dosages of Creatinine, AST/GOT, ALT/GPT are increased, it could be variable depends on the time from the collection of the blood to the separation of the serum and its dosage. It is important put up in doses the suitable blood volume according to the nominal value, otherwise it can be produced a overdosage of antiglycolitics (MIA Li) by blood ml, it can inhibit the enzymatics values in general. After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position in order to improve the mixing with the additive. Centrifugation recommended: 1800 g. / 15 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of centrifugation ). Stability: Guaranteed 15 months from its manufacture. Away from the carton, avoid the exposure to direct sunlight. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. The granules are not consider an additive, which after its centrifugation and because of its specific weight between cells and the plasma, a separator barrier is formed. At this way the barrier become stable ( permeable ) Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
800
Size of tube: lenght x diameter (mm)
100x16
80x13
70x12
CONTENT / ADDITIVE
MONOIODO ACETATE Li + GRANULES ACCELERATOR
CONTENT / ADDITIVE
STOPPER COLOUR
REF
blood ml
REF
blood ml
REF
blood ml
GRANULES
LIGHT GREY
1561521
8
1581524
4
1581525
2
ICO-002 Rev.: C Dated 09/2006
11
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
ANTIGLYCOLITIC ANTICOAGULANT
Sodium FLUORIDE + Potasium OXALATE
Additive: Watery solution with 20 gr. of sodium fluoride and 34,3 gr. of potasium oxalate / litre of solution. Activity: Sodium fluoride operates inhibiting the glucose comsumption by the red blood cells and the postasium oxalate operates like anticoagulant. Content: 1 - 1.4 mg of sodium fluoride and 1.8 – 2.3 mg of potasium oxalate / blood ml. Intention use: To determinate the glucose and other biochemical determinations, and emergencies with the exception of Na and K+ determinations. The glucose keeps stable during 24 hours if the sample will be in the refrigerator at +4ºC. It is not recommended to value K+ and Na+. Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 3 -5 slight mixed putting the tube at downside position. Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volume for it is defined. When through the time it is dried up, keeps its function but interfere in its activity, is recommended to increase the mixing with 5-8 balancing and rotative movements. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
800
800
1.000
Size of tube: lenght x diameter (mm)
80x13
70x12
55x12 CAP**
CONTENT / ADDITIVE
FX
Na FLUORIDE+ K OXALATE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
REF
blood ml
REF
blood ml
LIQUID
DARK GREY
1581704
4
1581705
2
1501706
1
** Special for Paediatric or small volumes of blood.
12
ICO-002 Rev.:C Dated 09/2006
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
Z - EMPTY ( without label )
--
Intention use: As a container of any kind of sample, whole blood, plasma, urine, etc… If would need to obtain serum, as it doesn´t have clotting accelerator, the serum will obtain by centrifugation after 2 hours from the collection. Don´t be used with organics solvents, solvents of alcholics types, terpenos, etc… Stability: Guaranteed 5 years from their manufacture. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
Size of tube: lenght x diameter (mm)
100x16
75x16
CONTENT / ADDITIVE
Z
EMPTY WITHOUT LABEL
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
--
WHITE
1561961
10
1.000 55x16 FLAT BOTTOM
REF
blood ml
1581962
7
REF
blood ml
1501963
5
800
800
1.000
80x13
70x12
55x12
REF
blood ml
1581964
5
CAP**
REF
blood ml
REF
blood ml
1581965
3
1501966
2
Volumes according to ISO 6710:1995 ** Special for Paediatric or small volumes of blood.
ICO-002 Rev.: C Dated 09/2006
13
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
Z - TUBE TREATED ( To obtain serum )
For SERUM
Additive: The inside wall of the tube is treated to get a behaviour like a glass tube (unsticking easily the clot of the wall). Activity: The treatment improves the retraction of clot, although this is produced in the time neccesary for a glass tube. Content: Moreover of the treatments of the wall, there are tubes with PS Gel or PS Granules which operate like a separation barrier (serum-clot). Intention use: To obtain serum for clinical biochemistry. Improve the blood clotting, getting the blood is clotting before 10 minutes and the clot is retracted before 60 minutes, obtainning a serum without fibrin after 60 minutes from the collection and 10 minutes after the centrifugation. These are recommended to biochemical determinations, total proteins valuations and division, differents enzymes and isoenzymes, Aldolasa, alfa-Amilasa, LDH, GOT/ASAT, GPT/ALAT, LAP, etc…(have been detected interferences in determinations of Al, Parathormona, Tripsine and Chemotripsine). Valuations of electrolytes: sodium, potasium, magnesium, lithium, calcium, etc…or oligoelements, copper, iron, PBI, etc…; hormones: T-3, T-4; pigments: bilirrubine, lipids, carontens, triglicerides, total cholesterol, HDL, LDL, VLDL, etc…; nitrogenous sustances: urea, creatinine, uric acid, etc… There are three kinds: Only with tube treated. With tube treated and separator gel, after the centrifugation is formed a separation barrier between the red blood cells-clot and the serum, it allows a clean collection and without any contamination of the serum. With tube treated and granules PS, they operate like a separation barrier between the red blood cellsclot and the serum. Recomendations for use: After inserting the sample in the tube ( following the recomendations to fill ), do 2 -3 slight mixed putting the tube at downside position. Centrifuge when the clotting have been done ( aproximately 2 hours ); recommended 1800 g. / 10 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of centrifugation ). Once the sample is centrifugated and keep at 4ºC, it can be kept for 48 hours, although some values could not stay stable. If you want to extend the conservation, separate the serum and keep at -20ºC. Stability: The kind with gel is guaranteed 2 years, the others kinds 3 years from their manufacture In all kinds the treatment lose its stability when are put to above 50ºC. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Note: The gel and the granules are not consider an additive. After its centrifugation the gel is placed, because of its specific weight, between cells and the plasma, a separator barrier is formed. If the tube is going to be carried, it is recommended to leave the tube 1 hour at veritical position, at this way the barrier become stable. When there are granules happen the same but the separator barrier is permeable.
Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
800
800
1.000
Size of tube: lenght x diameter (mm)
100x16
75x16
80x13
70x12
55x12
CONTENT / ADDITIVE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
REF
blood ml
REF
blood ml
REF
blood ml
Z
EMPTY WITH LABEL
SPRAY
WHITE
1561971
10
1581974
5
1581975
3
1501976
2
Z
SEPARATOR GEL FOR SERUM
GEL
WHITE
1561981
9
1581984
4
1501986
1.5
Z
GRANULES PS FOR SERUM
GRANULES
WHITE
1561951
9
1581954
4
1501956
1.5
REF
1581952
blood ml
6
** Special for Paediatric or small volumes of blood. 14
CAP**
ICO-002 Rev.:C Dated 09/2006
APPLICATIONS OF
AQUISEL
® TUBES ACCORDING TO DIFFERENT ADDITIVES
Z - CLOTTING ACCELERATOR ( To obtain serum )
CLOTTING ACCELERATOR
Additive: The clotting accelerator used has protein nature, it is made up by an enzyme very stable at ambient temperature. Activity: Make operate to turn the Fibrinogen into Fibrin, reducing the clotting time. Content: Clotting accelerator, or depends on the formats contain PS Gel or PS Granules. Intention use: To obtain serum for clinical biochemistry. Improve the blood clotting, getting the blood begin the process of clotting before 15 minutes and the clot is retracted before 30 minutes, obtainning a serum without fibrin after 30 minutes from the collection and 10 minutes after the centrifugation. These are recommended to biochemical determinations, total proteins valuations and division, differents enzymes and isoenzymes, Aldolasa, alfa-Amilasa, LDH, GOT/ASAT, GPT/ALAT, LAP, etc…(have been detected interferences in determinations of Al, Parathormona, Tripsine and Chemotripsine). Valuations of electrolytes: sodium, potasium, mangesium, lithium, calcium, etc…or oligoelements, copper, iron, PBI, etc…; hormones: T-3, T-4; pigments: bilirrubine, lipids, carontens, triglicerides, total cholesterol, HDL, LDL, VLDL, etc…;nitrogenous sustances: urea, creatinine, uric acid, etic… There are three kinds: Only with clotting accelerator, getting to go quick at the mixing. With liquid clotting accelerator and separator gel, moreover of reducing the clotting time, the gel forms a separation barrier between the clot and the serum, it allows obtain the serum of a clean way and without any contamination. With clotting accelerator dried up and PS granules, moreover of reducing the clotting time, the granules have two functions, one make better the mixing of the clotting accelerator with the blood and the other one operates like a separation barrier between the red blood cells-clot and the serum. Recomendations for use: After inserting the sample into the tube ( following the recomendations to fill ), do 2 -3 slight mixed putting the tube at downside position. After 30 minutes centrifuge; recommended 1800 g. / 10 minutes / 15ºC - 24ºC ( these parameters are guiding, depends on the format and the characteristics of centrifugation ). Once the sample is centrifugated and keep at 4ºC, it can be kept for 48 hours, although some values could not stay stable. If you want to extend the conservation, separate the serum and keep at -20ºC. Stability: The kind of cloting accelerator with gel is guaranteed 15 months, the others kinds 3 years from theirs manufacture. In all kinds the accelerator could lose its stability when are put to above 50ºC. Storage: Avoid the exposure to direct sunlight and it is recommended storage between 4º and 35ºC. Note: The gel and the granules are not consider an additive. After its centrifugation the gel is placed, because of its specific weight, between cells and the plasma, a separator barrier is formed. If the tube is going to be carried, it is recommended to leave the tube 1 hour at veritical position, at this way the barrier become stable. When there are granules happen the same but the separator barrier is permeable.
Presentation and references AQUISEL®TUBE according to the different kind of analyses: see products table
Identify colour of stoppers Quantity of tubes in each external carton (racks of 100 uts.)
600
800
800
800
1.000
Size of tube: lenght x diameter (mm)
100x16
75x16
80x13
70x12
55x12 CAP**
CONTENT / ADDITIVE
KIND OF DOSAGE
STOPPER COLOUR
REF
blood ml
Z
CLOTTING ACCELERATOR
LIQUID
RED
Z
CLOTTING ACCELERATOR AND SEPARATOR GEL
LIQUID AND GEL
RED
1561811
9
Z
CLOTTING ACCELERATOR AND GRANULES PS FOR SERUM
GRANULES
RED
1561941
9
REF
1581942
blood ml
6
REF
blood ml
1581814
4
1581944
4
REF
1581945
blood ml
3
REF
blood ml
1501806
2
1501816
1.5
1501946
1.5
** Special for Paediatric or small volumes of blood.
ICO-002 Rev.: C Dated 09/2006
15
PRODUCT PRESENTATION The AQUISEL® tubes are presented ready to be used with the suitable additive for each function and volume. They are placed in racks of 100 pcs., the racks are made in EPS, they are designed to facility their handling. Every 50 pcs. are cover with a lid that protect the stopper outside from possible contamination ( particles,... ) which could be produced during the storage and transport. Once the sample has been introduced, the tubes can be carry with the same racks, free, by pneumatic means, by post, etc...
LABEL INFORMATION ®
TUBE LABEL
LABEL OF SHIPPING CARTON
K3E / EDTA 3K IVD
2005-09
123456
1501226 000000 AAAA-MM LOT
REF
0,5 ml
K3E / EDTA 3K
IVD
EAN-128 BAR CODE IVD
Code alphanumeric / additive In vitro diagnostic medical device ( D. 98/79/CE)
Temperature limitation recommmended for storage
CE mark ( D. 98/79/CE)
Manufacturer
2
Do not reuse ( EN-980 )
!
Consult accompanying documents ( EN-980 )
Fagile - handly with care
Expiry date ( EN-980 ) REF LOT
!
Reference to request the product ( EN-980 ) Manufacture Lot ( 6 digits - the two first: the last two number of manufacture year and the rest four: a correlative number of manufacture ) / ( EN-980 )
Place the box as show the arrows
Keep dry
Level filled - guiding line to fill the tube 2.5 ml
Keep away from direct sunlight
Nominal volume - volume of blood to be introduced
PRESENTATION OF SHIPPING CARTONS
16
TUBE SIZE (mm.)
TUBES PER BOX (Uts.)
BOX DIMENSIONS (cm.) (L x D x W)
MAX. WEIGHT (Kg.)
100x16
600
47x23x34
4,3
75x16
800
47x23x36
4,3
55x16
1000
47x23x34
4
80x13
800
39x22x36
3,5
70x12
800
36x21x34
3
55x12
1000
36x21x34
3,5
ICO-002 Rev.:C Dated 09/2006
GENERAL INSTRUCTIONS FOR AQUISEL® TUBE STORAGE Storage temperature recommended: 4º - 35ºC (40º - 115ºF ) Avoid exposure to direct sunlight. If the maximum temperature recommended is exceeded, it could change the quality of the tubes ( for example: dry up the additives, discolour, ... ) The tubes with sample allow a storage up to -20ºC. PRECAUTIONS / CAUTIONS 1.- Not use tubes if foreing matter is present, or if could see the tube would have lost its phisical wellbeing. 2.- Filling the tubes according to the nominal volume shown in the label, if the ratio sample-additive is not kept this could become a bad preservation of the sample or change the results. 3.- Not shake the tubes vigorously it could produce haemolysis and change the analysis results. 4.- An insufficient mix of the sample with the additive it could become a bad preservation of the samples and because of this over the determinations. 5.- The almost additives are colourless and odourless. Don´t use the tubes where the additive has changed its colour ( exception: teatred tubes for serum and with clotting accelerator, through the time the teatred and the clotting accelerator tend towards yellow, but the product is not affected ) 6.- Not use tubes after expiration date CAUTIONS a.- Handle all biological samples and blood collection ries ( lancets, needles, luer adapters, ... ) according to the policies and procedures of your facility ( use gloves, avoid to breth aerosol,.. ) b.- Obtain appropiate medical attention in the case of any exposure to biological samples, since they may transmit HIV , hepatitis B and C or other infectious disease. c.- Additional manipulation of sharps increases the potencial for needle stick injury. d.- Wear gloves reduce the infections risk.
CENTRIFUGATION For the centrifugation you can use any centrifuge. Nevertheless, the diameter and the addapter height should be taken on, in order to avoid the unplugging of the tubes during the centrifugation. The correct way of placing the tubes inside the addapter of the centrifuge should be checked. Within kind of tube and according to the determinations to be done, the guiding recommendations are shown. 2 The general recommendations for the centrifugation are: From 1500g to 3000 g ( g = 0.00001118 x r x V ) Recommending to centrifuge with cooled centrifugates ( temperature: 15º - 24ºC ). When there is an element which function is doing a separator barrier ( Gel, PS granules ), in centrifuges with swing out rotor the separator barrier will be better defined than the centrifuges with angles rotor. Not recommended a second centrifugation. J.P. SELECTA s.a. has special addapters to centrifuge AQUISEL ® tubes with models MIXTASEL, CENTRONIC, MEDITRONIC y MEDIFRIGER. DISPOSAL The general hygiene guidelines and legal regulations for the proper disposal and infectuous material should be considered and followed ( laboratories / hospitals ).
ICO-002 Rev.: C Dated 09/2006
17
PRODUCTS TABLE AQUISEL® tubes with valve-stopper Number of tubes in the shipping boxes (racks of 100uts. )
600
800
1.000
800
800
1.000
Nominal size of the tube: L x diameter ( mm )
100x16
75x16
55x16 FLAT BOTTOM
80x13
70x12
55x12 CAP
K3E
K3E
4 NC
STOPPER COLOUR
KIND OF DOSAGE
CONTENT / ADDITIVE
EDTA3K
LIQUID
EDTA3K
blood ml
REF
blood ml
REF
blood ml
REF
blood ml
1501103
4
1581104
4
1581105
3
1501106
2
1501113
2
1581114
2,5
1501116
1
1501123
4*
1581124
4*
1501126
0,5
1501133
2*
1581134
2,5*
1501223
2
1501206
1
MAUVE
LIQUID
BLACK
1581204
º
1581209
CITRATE 3 Na 0,106 M~3,8% 1:9 CLOTTING FACTORS
LIQUID
LH
Li HEPARIN
LIQUID
GREEN
LH
Li HEPARIN WITH SEPARATOR GEL
LIQUID AND GEL
GREEN
LH
Li HEPARIN + MONOIODO ACETATE Li
LIQUID
GREEN
MONOIODO ACETATE Li + GRANULES ACCELERATOR
GRANULES
LIGHT GREY
FX
Na FLUORIDE + K OXALATE
LIQUID
DARK GREY
Z
EMPTY WITHOUT LABEL
Z
EMPTY WITH LABEL FOR SERUM
Z
9NC
REF
blood ml
REF
MAUVE
LIQUID
CITRATE 3 Na 0,106 M~3,8% 1:4 VSG/ESR
blood ml
REF
LIGHT BLUE 1561401
1561521
10
•
1
1581304
4
1581404
8
5
1501226
1581305
1581405
—
0,32
1501306
1
1501326
0,5
1501406
1
1501416
1
1501606
1
2
2
1581604
4
1581524
4
1581525
2
1581704
4
1581705
2
1501706
1
1581964
5
1581965
4
1501966
2,5
1581975
4
1501976
2,5
10
SPRAYED
WHITE
1561971
10
1581974
5
SEPARATOR GEL FOR SERUM
GEL
WHITE
1561981
9
1581984
4
1501986
2
Z
GRANULES PS FOR SERUM
GRANULES
WHITE
1561951
9
1581954
4
1501956
2
Z
CLOTTING ACCELERATOR
LIQUID
RED
1501806
2,5
Z
CLOTTING ACCELERATOR AND SEPARATOR GEL
LIQUID AND GEL
RED
1561811
9
1501816
2
Z
CLOTTING ACCELERATOR AND GRANULES PS FOR SERUM
GRANULES
RED
1561941
9
1501946
2
1581942
1501963
1,2
1561961
1581952
7
4
1581205
WHITE
Box Dimensions
1581962
1,6
6
6
1581814
4
1581944
4
1581945
3
Lenght (cm)
47
47
47
39
36
36
Width (cm)
23
23
23
22
21
21
Height (cm)
34
34
34
36
34
34
Weight (Kg)
4,3
4,3
4,0
3,5
3,0
3,5
* Special for Haematology automatic machines ( special cut of the stopper 5 mm ) Tube 75x13 for AQUISEL pipette P2. — Special tube for AQUISEL pipette P4 MICRO • Special tube for AQUISEL pipette P3
º
AQUISEL® tubes - stopper without valve CONTENT / ADDITIVE
K3E
18
EDTA 3K
KIND OF DOSAGE
LIQUID
STOPPER COLOUR
MAUVE
Nº OF TUBES PER BOX
REF
blood ml
SIZE TUBE Length x Ø mm.
BOX SIZE cm. L/W/H
WEIGHT Kg
800
1681154
3
80 x 13
39 / 22 / 36
3
ICO-002 Rev.:C Dated 09/2006
Directions for use tubes with valve-stopper AQUISEL : to subsitute ICO-002 Rev: B Dated : 10/2003 for ICO-002 Rev: C Dated 09/2006
Manufacturer :
Aquisel s.l. Crta.Nacional II, km 585,1 08630 ABRERA (Barcelona) Spain
Dealer:
J.P.Selecta s.a. Crta.Nacional II, km 585,1 08630 ABRERA (Barcelona) Spain Tf.: (34) 93 770 08 77 - Fax (34) 93 770 23 62 Web: www.jpselecta.es - @mail: [email protected]
AQUISEL® TUBE Dealer:
ICO-002 Rev.: C Dated 09/2006
19
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