AQUISEL Tubos Instrucciones-English

8/18/2019 AQUISEL Tubos Instrucciones-English

1/20ICO-002 Rev.: C Dated 09/2006 1

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 contact 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, withan 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 unnecessaryrisks with the system of

valve-stopper


2/20ICO-002 Rev.:C Dated 09/20062

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. Thisreduces 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

contact.

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 theplunger, 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 ).

The AQUISEL tubes are prepared to be filled, place the CAP-

GALET in the first tube to be used according to the positionshowed 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.

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 shakeof 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.

Introduce the bevel parallel to thecross-cut onto stopper

Correct position Incorrect position

Filling the tube with CAP-GALET


3/20ICO-002 Rev.: C Dated 09/2006 3

TAKING SAMPLES FROM AQUISEL ® TUBES

The samples can be withdrew from AQUISEL®tubes through thestopper 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® systemopen. 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.

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-microtubes 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. Theblood 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.


4/20ICO-002 Rev.:C Dated 09/20064

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 i ts 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 dif ferents 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.

Checking Points

ASSEMBLY TUBE (AUTOMATIC)

INCOME INSPECTION - AQUISEL s.l.

CUT

STOPPER CUT

Tube Stopper cut Label Additive

TUBE STOPPER ADDITIVELABEL

TAPVALTAPVAL TubeTube

POLYPROPYLENE (PP)

INJECTION

TUBE

POLYPROPYLENE (PP)

INJECTION

TUBE

SYNTHETIC (SBES)

INJECTION

STOPPER

SYNTHETIC (SBES)

INJECTION

STOPPER

LABELLABEL ADDITIVES RAW MATERIAL

CHEMICAL ELABORATION

ADDITIVE

ADDITIVES RAW MATERIAL

CHEMICAL ELABORATION

ADDITIVE

1 111 11 22

33

44 6655

88

99

77

AQUISEL Tube


5/20ICO-002 Rev.: C Dated 09/2006 5

KINDS OFAQUISEL ® TUBESACCORDING TO THE FORMATThey 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)

(*) H1 and H2 are registred tradermarks from Tecknicon

(**) STKR is a registred tradermark Counter Coulter

(***) COVAS is a registred tradermark Roche

ACCORDING TO THE NOMINAL LENGHT OF THE CROSS-CUT VALVE

Tube

D iam e te r

C ut

Le n gh t

(n om i n al )

M a x i m u -

m

D iam e te r

o f us e ful

( m m )

U s e E x a m ple

1 6

1 0 9 G e ne ra l B lue P ip e tte Tip (8 m m )

5 4 .5T .55x16 /

V.S.G.P ipe t tt e E .S .R . (4 .5 m m )

5 4T .55x16

E D T A 3K M ach ines H 1 y H 2 T echn icon (* )

1 3

8 7 G e ne ra lYellow Pipette T ip. Ap par atus with automatic take samp le of

Hematology.

5 4T .80x13

E D T A 3K H 1 ( * ) ; H 2 ( * ) ; S T K R ( * * ) ; C O VA S ( * * * )

1 2 7 6 G e ne ra lApparatus with automatic take sample of hematology. Different kinds

of glass pipet tes . Yellow Pipette T ip

Stopper maximum Ø

Tube top internal Ø

Lenght: tube + stopper

Lenght tube without stopper

ExternalØ of tube

Volume with stopper(ml) (*)

Stopper maximum Ø

Tube top internal Ø

Lenght: tube + stopper

Lenght tube without stopper

ExternalØ of tube

Volume with stopper(ml) (*)

19.7

13.5

101.1

99.2

15.2

10

100x16

19.7

13.5

101.1

99.2

15.2

10

100x16

19.7

13.5

77

75.2

15.2

7

75x16

19.7

13.5

77

75.2

15.2

7

75x16

19.7

13.5

56.6

54.6

15

5

55x16

19.7

13.5

56.6

54.6

15

5

55x16

16.7

11

80.3

78.5

12.3

5

80x13

16.7

11

80.3

78.5

12.3

5

80x13

16.7

11

75.7

74.3

12.2

4

75x13

16.7

11

75.7

74.3

12.2

4

75x13

16.7

11

75.7

74.3

12.2-8.7

1.25ESR

75x13

Esp.ESR

16.7

11

75.7

74.3

12.2-8.7

1.25ESR

75x13

Esp.ESR

15.4

10

70.6

69

11.3

3

70x12

15.4

10

70.6

69

11.3

3

70x12

15.4

10

56

54.5

11.3

2

55x12

CAP

15.4

10

56

54.5

11.3

2

55x12

CAP

(*) ISO 6710


6/20ICO-002 Rev.:C Dated 09/20066

APPLICATIONS OF AQUISEL ® TUBES ACCORDING TO DIFFERENT ADDITIVES

K3E - EDTA 3K ( Tr ipotass ic salt of ethylenedini tr i lo tetracetic acid )) ANTICOAGULANT

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 i t 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: seeproducts table

Identify colour of stoppers

Quantity of tubes in each external carton

(racks of 100 uts.)1.000 800 800 1.000

Size of tube:

lenght x diameter (mm)55x16

FLAT BOTTOM80x13 70x12

55x12

CAP**

CONTENT / ADDITIVEKIND OFDOSAGE

STOPPERCOLOUR

RE Fblood

mlREF

bloodml

RE Fblood

mlRE F

bloodml

K 3E EDTA 3K LIQUID MAUVE1501103 4 1581104 4 1581105 3 1501106 2

1501113 2 1581114 2,5 1501116 1

K 3E EDTA 3K LIQUID MAUVE1501123 4* 1581124 4* 1501126 0,5

1501133 2* 1581134 2,5*

K 3E EDTA 3K LIQUID MAUVE 1681154 3 •

** Special for Paediatric or small volumes of blood.

* Special for automatic machines of Haematology ( special stopper cut 5mm ).

•

Reference with stopper no cut


7/20ICO-002 Rev.: C Dated 09/2006 7

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 Citrate3Na 5.5 H2O of crystallize and suitable stabilizers).

Activity: Anticoagulant operates precipiting the calcium ion Ca++ of the blood, in order to avoid itsclotting.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 ( methodrecommended 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 betweenthe additive and the sample.Stability: Guaranteed 12 to 15 months from their manufacture, depends on the format and volumefor 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: seeproducts table.

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



Quantity of tubes in each external carton (racksof 100 uts.)

1.000 800 800 1.000

Size of tube:lenght x diameter (mm)

55x16FLAT BOTTOM

75x13 70x1255x12CAP**


STOPPERCOLOUR REF

bloodml

REFblood

mlREF

bloodml

RE Fblood

ml

4N C

CITRATE 3 N a0,106 M~3,8% 1:4

ESRLIQUID BLACK

1501223 2

1581204

1,6 1581205 1,2 1501206 1

15812091

1501226

0,32

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.


8/20ICO-002 Rev.:C Dated 09/20068

Additive: Watery solution of Citrate 3Na 0.106 M (is equal to 3.8% (weight/volume) with Citrate 3Na5.5 H2O of crystallize and suitable stabilizers).

Activity: Anticoagulant operates precipitating the calcium ion (Ca++) of the blood, in order to avoidits 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 withthe Citrate is recommended keep at 4ºC.Recomendations for use:It is very important follow the recomendations for the collection, the compression over the vain shouldbe the minimum as possible, it is necessary insert before 30 seconds the sample into the tube to mixwith the Citrate, the ratio blood / Citrate shouldn´t exceeded the filling level +/-5%, the mixing must bedoing with 3 - 5 movements of balancing, invert and rotative movements simultaneously, avoidoverexposure at the vacuum and make foam, etc…

Protombine time without separate the blood plasma from the red blood cells: it is necessary do it before4 hours after the collection, if have to extend its use you will separate the blood plasma from the redblood cells and keep it in refrigerator at 4ºC (recommended no more than 6 hours), for more time itmust 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.

9NC - CITRATE 3 Na 0.106 M (3.8%) (1:9) Clott in g Factor s ANTICOAGULANT


Presentation and references AQUISEL ®TUBE according to the different kind of analyses: seeproducts table



Quantity of tubes in each external carton(racks of 100 uts.)

800 800 1.000


80x13 70x1255x12CAP**


STOPPERCOLOUR REF

bloodml

REFblood

mlREF

bloodml

9NCCITRATE 3 Na0,106 M~3,8% 1:9

CLOTTING FACTORS

LIQUIDLIGHTBLUE

1581304 4 1581305 2

1501306 1

1501326 0,5


9/20ICO-002 Rev.: C Dated 09/2006 9

LH - Li th ium Hepar in 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 plasmaseparation inmediately.• With Li Heparin and separator gel( 1 ), to do the separation between the plasma and the redblood cells, avoiding the crossing of substances which values are much more higher inside the red bloodcells than the plasma, these happen with K+, AST, ALT, LDH, etc…At this way moreover avoiding theglucolitique, the plasma keeps stable with a simple centrifugation, so it is not necessary putting intoanother second tube.Both are not recommended to value TDM, Li+. Don´t use at blood banks ( inhibiting PCR ).Recomendations for use:


tube at downside position, in order to do better the mixed blood sample with additive. When it is neccesarycentrifuge; 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 itsactivity, 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.


Presentation and references AQUISEL ®TUBE according to the different kind of analyses: see

products table


( 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 isrecommended to leave the tube 1 hour at veritical position, at this way the barrier become stable.



(racks of 100 uts.)600 800 800 1.000


100x16 80x13 70x1255x12CAP**

CONTENT / ADDITIVE KIND OFDOSAGE

STOPPERCOLOUR REF bloodml

REF bloodml

REF bloodml

REF bloodml

LH Li HEPARIN LIQUID GREEN 1561401 10 1581404 4 1581405 2 1501406 1

LH Li HEPARIN

WITH SEPARATOR GEL

LIQUID

AND GELGREEN 1501416 1


10/20


11/20ICO-002 Rev.: C Dated 09/2006 11

MONOIODOACETATE L i + CLOTTING ACCELERATOR / GRANULES PS ANTIGLYCOLITIC

Additive: Mixing of granules PS cover with Monoiodo Acetate Li some of them and the others withclotting accelerator, all of them dried up.Activity: The Monoiodo Acetate Li operates like antiglycolitic for analyses of serum, it inhibits theglucose comsumption by the red blood cells, keep stable more than 24 hours at 4ºC without separate theserum 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 redblood 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 serumfrom the red blood cells (clot).Recomendations for use:Recommended to determinations of glucemia, urea and other biochemical determinations with theexception 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 hoursfrom 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 theblood 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 itcan be produced a overdosage of antiglycolitics (MIA Li) by blood ml, it can inhibit the enzymaticsvalues in general.


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 todirect 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 weightbetween cells and the plasma, a separator barrier is formed. At this way the barrier become stable (permeable )




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 / ADDITIVECONTENT /ADDITIVE

STOPPERCOLOUR REF

bloodml

REFblood

mlREF

bloodml

MONOIODO ACETATE Li +

GRANULES ACCELERATORGRANULES

LIGHT

GREY1561521 8 1581524 4 1581525 2


12/20ICO-002 Rev.:C Dated 09/200612

Sodium FLUORIDE + Potasium OXALATE ANTIGLYCOLITIC

- ANTICOAGULANT

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 thepostasium oxalate operates like anticoagulant.Content: 1 - 1.4 mg of sodium f luoride 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 exceptionof Na and K+ determinations. The glucose keeps stable during 24 hours if the sample will be in therefrigerator at +4ºC.It is not recommended to value K+ and Na+.Recomendations for use:


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, isrecommended 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






(racks of 100 uts.)800 800 1.000

Size of tube:lenght x diameter (mm) 80x13 70x12

55x12CAP**


STOPPERCOLOUR

REFblood

mlREF

blood

mlREF

blood

ml

FXNa FLUORIDE+

K OXALATELIQUID

DARKGREY

1581704 4 1581705 2 1501706 1


13/20ICO-002 Rev.: C Dated 09/2006 13

Z - EMPTY ( with out 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.





(racks of 100 uts.)600 800 1.000 800 800 1.000

Size of tube:

lenght x diameter (mm)100x16 75x16

55x16FLAT BOTTOM

80x13 70x1255x12CAP**


STOPPERCOLOUR

REFblood

mlREF

bloodml

REFblood

mlREF

bloodml

REFblood

mlREF

bloodml

Z

EMPTY

WITHOUT

LABEL

-- WHITE 1561961 10 1581962 7 1501963 5 1581964 5 1581965 3 1501966 2

Volumes according to ISO 6710:1995


14/20ICO-002 Rev.:C Dated 09/200614

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 timeneccesary for a glass tube.Content: Moreover of the treatments of the wall, there are tubes with PS Gel or PS Granules whichoperate like a separation barrier (serum-clot).Intention use:To obtain serum for clinical biochemistry. Improve the blood clotting, getting the blood is clotting before10 minutes and the clot is retracted before 60 minutes, obtainning a serum without fibrin after 60minutes 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 andChemotripsine).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 thered blood cells-clot and the serum, it allows a clean collection and without any contamination of theserum.With tube treated and granules PS, they operate like a separation barrier between the red blood cells-clot 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 manufactureIn 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 specificweight, between cells and the plasma, a separator barrier is formed. If the tube is going to be carried, it is recommended toleave the tube 1 hour at veritical position, at this way the barrier become stable. When there are granules happen the samebut the separator barrier is permeable.





600 800 800 800 1.000


100x16 75x16 80x13 70x12 55x12CAP**

CONTENT / ADDITIVEKIND OF

DOSAGE

STOPPER

COLOURREF

blood

mlREF

blood

mlREF

blood

mlREF

blood

mlREF

blood

ml

ZEMPTY WITH

LABELSPRAY WHITE 1561971 10 1581974 5 1581975 3 1501976 2

ZSEPARATOR

GEL FORSERUM

GEL WHITE 1561981 9 1581984 4 1501986 1.5

ZGRANULES PS

FOR SERUMGRANULES WHITE 1561951 9 1581952 6 1581954 4 1501956 1.5


15/20ICO-002 Rev.: C Dated 09/2006 15

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 atambient 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 theprocess of clotting before 15 minutes and the clot is retracted before 30 minutes, obtainning a serumwithout 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 andChemotripsine).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, totalcholesterol, 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 aseparation 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 granuleshave two functions, one make better the mixing of the clotting accelerator with the blood and the other oneoperates like a separation barrier between the red blood cells-clot and the serum.Recomendations for use:


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 yearsfrom 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 thetube 1 hour at veritical position, at this way the barrier become stable. When there are granules happen the same but theseparator barrier is permeable.




600 800 800 800 1.000


100x16 75x16 80x13 70x12 55x12CAP**

CONTENT / ADDITIVEKIND OF

DOSAGE

STOPPER

COLOURREF

bloodml

REFblood

mlREF

bloodml

REFblood

mlREF

bloodml

Z CLOTTING ACCELERATOR LIQUID RED 1501806 2

ZCLOTTING ACCELERATOR AND

SEPARATOR GEL

LIQUID

AND GELRED 1561811 9 1581814 4 1501816 1.5

ZCLOTTING ACCELERATOR AND

GRANULES PS FOR SERUMGRANULES RED 1561941 9 1581942 6 1581944 4 1581945 3 1501946 1.5



16/20ICO-002 Rev.:C Dated 09/200616

TheAQUISEL® 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...

PRESENTATION OF SHIPPING CARTONS

TUBESIZE

(mm.)

TUBESPER 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

PRODUCT PRESENTATION

Fagile - handly with care

123456 2005-09

IVD !

K3E / EDTA 3K Code alphanumeric / additive

In vitro diagnostic medical device ( D. 98/79/CE)

CE mark ( D. 98/79/CE)

Do not reuse ( EN-980 )

Consult accompanying documents ( EN-980 )

Expiry date ( EN-980 )

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 )

Level filled - guiding line to fill the tube

Nominal volume - volume of blood to be introduced

IVD

2!

REF

LOT

Temperature limitation recommmended for

storage

Manufacturer

Place the box as show the arrows

Keep dry

Keep away from direct sunlight2.5

ml

LABEL OF SHIPPING

CARTON

TUBE LABEL

LABEL INFORMATION

EAN-128 BAR CODE

K3E / EDTA 3K

0,5

ml

®

IVD

1 5 0 1 2 2 6

0 0 0 0 0 0

A A A A - M M

L O T

R E F


17/20ICO-002 Rev.: C Dated 09/2006 17

GENERAL INSTRUCTIONS FORAQUISEL® 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 al low 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 i t 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

CAUTIONSa.- Handle all biological samples and blood collection accesories ( 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.

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.

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.

CENTRIFUGATION

DISPOSAL

The general hygiene guidelines and legal regulations for the proper disposal and infectuous

material should be considered and followed ( laboratories / hospitals ).

2


18/20


19/20ICO-002 Rev.: C Dated 09/2006 19

Dealer:

AQUISEL ® TUBE

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]

http://www.jpselecta.es/mailto:[email protected]:[email protected]://www.jpselecta.es/


20/20

AQUISEL Tubos Instrucciones-English

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