Heparin Assay Cartridge
Heparin-Testkartusche
Cartucho para análisis de heparina
Cartouche test de concentration d'héparine
Cartuccia per l'analisi dell'eparina
Instructions for Use • Gebrauchsanweisung •
Instrucciones de uso • Mode d’emploi • Istruzioni per l’uso
Caution: Federal law (USA) restricts
this device to sale by or on the order of a
physician.
Trademarks may be registered and are the property of their respective owners.
Marken sind eventuell eingetragen und sind das Eigentum ihrer jeweiligen Inhaber.
Las marcas comerciales pueden estar registradas y pertenecen a sus respectivos
propietarios.
Les marques commerciales mentionnées peuvent être déposées et appartiennent à
leurs propriétaires respectifs.
I marchi di fabbrica possono essere registrati e sono di proprietà dei rispettivi titolari.
Explanation of symbols on package labeling /
Erläuterung der Symbole auf dem
Verpackungsetikett / Explicación de los símbolos
que aparecen en la documentación del envase /
Explication des symboles des étiquettes sur
l'emballage / Spiegazione dei simboli presenti sulle
etichette della confezione
Conformité Européenne (European Conformity).
This symbol means that the device fully
complies with the European Council
Directive IVDD: 98/79/EC. / Conformité
Européenne (Europäische Konformität). Dieses
Symbol besagt, dass das Produkt allen
Vorschriften der Direktive 98/79/EG des
Europäischen Parlaments und des Rates
entspricht. / Conformité Européene
(Conformidad europea). Este símbolo indica
que el dispositivo cumple totalmente la Directiva
del Consejo Europeo sobre dispositivos de
diagnóstico in vitro (DDIV): 98/79/CE. /
Conformité Européenne. Ce symbole signifie
que le dispositif est entièrement conforme à la
Directive européenne IVDD relative aux
diagnostics in vitro : 98/79/CE. / Conformité
Européenne (Conformità europea). Questo
simbolo significa che il dispositivo è pienamente
conforme alla Direttiva IVDD 98/79/CE del
Consiglio europeo.
Sterilized Using Irradiation / Mittels Strahlung
sterilisiert / Esterilizado mediante irradiación /
Stérilisation par irradiation / Sterilizzato con
radiazioni ionizzanti
Nonsterile / Unsteril / No estéril / Non stérile /
Non sterile
Do Not Reuse / Nicht wiederverwenden / No
reutilizar / Ne pas réutiliser / Non riutilizzare
Use-By Date / Zu verwenden bis einschließlich /
No utilizar después de / À utiliser jusqu'au /
Utilizzare entro
Manufactured In / Hergestellt in / Fabricado en /
Lieu de fabrication / Fabbricato in
Lot Number / Chargennummer / Número de
lote / Numéro de lot / Numero di lotto
Quantity / Menge / Cantidad / Quantité /
Quantità
Consult Instructions for Use /
Gebrauchsanweisung beachten / Consultar las
instrucciones de uso / Consulter le mode
d'emploi / Consultare le istruzioni per l'uso
1
For US Audiences Only / Gilt nur für Leser in
den USA / Solo aplicable en EE. UU. /
Uniquement pour les États-Unis /
Esclusivamente per il mercato statunitense
Temperature Limit / Temperaturbereich / Límite
de temperatura / Limite de température / Limiti
di temperatura
Fragile, Handle with Care / Vorsicht,
zerbrechlich / Frágil, manipular con cuidado /
Fragile, manipuler avec précaution / Fragile,
maneggiare con cura
Catalog Number / Katalognummer / Número de
catálogo / Numéro de référence / Numero di
catalogo
Manufacturer / Hersteller / Fabricante /
Fabricant / Fabbricante
Authorized Representative in the European
Community / Autorisierter Repräsentant in der
Europäischen Gemeinschaft / Representante
autorizado en la Comunidad Europea /
Représentant agréé dans la Communauté
européenne / Rappresentante autorizzato nella
Comunità Europea
This Way Up / Diese Seite oben / Este lado
hacia arriba / Placer ce côté vers le haut /
Questa parte rivolta verso l'alto
In Vitro Diagnostic Medical Device /
Medizinisches Gerät zur In-vitro-Diagnostik /
Dispositivo médico para diagnóstico in vitro /
Dispositif médical de diagnostic in vitro /
Dispositivo medico diagnostico in vitro
Biological Risks / Biogefährdung / Riesgos
biológicos / Risques biologiques / Rischi
biologici
2
Heparin Assay Cartridge
1. Intended Use
For use in measuring the heparin concentration of a fresh whole blood
sample by performing protamine titration.
For in vitro diagnostic use.
2. Summary
Medtronic heparin assay cartridges perform a semi-quantitative
measurement of heparin concentration in a whole blood sample. Heparin
is measured by titration against known quantities of protamine added to
the cartridge channels. The channel whose quantity of protamine
neutralizes the heparin in the test sample will have the shortest clotting
time. The concentration of heparin is calculated based on the known
amount of protamine. Dilute thromboplastin is added to heparin assay
cartridges to accelerate the reaction time. Heparin assay cartridges
measure heparin levels from 0 to 6.0 mg/kg body weight or
0 to 8.2 units/mL. Heparin assay cartridges are available as
4 or 6 channel cartridges.
3. Principles
Each heparin assay cartridge channel contains an increasing quantity of
protamine sulfate and an equal amount of dilute thromboplastin. The
protamine in each channel neutralizes a specific amount of heparin. A
fresh whole blood sample is delivered to each cartridge channel, and the
reagents are mixed with the test sample by the Medtronic HMS Plus
instrument to initiate coagulation. The first channel to clot is the channel in
which the amount of protamine most closely neutralizes all of the heparin
in the test sample without an excess of either heparin or protamine.
The end point of the test is the detection of clot formation. The HMS Plus
instrument detects clot formation by measuring the rate of fall of the
plunger contained in each cartridge channel. The plunger assembly falls
rapidly through an unclotted sample. A fibrin web formed during clotting
impedes the rate of plunger assembly descent. Clot formation is detected
by a photo optical sensor located in the actuator assembly of the
instrument.
4. Reagents
Heparin assay cartridges are formulated using United States
Pharmacopoeia (USP) grade protamine sulfate for injection. The
protamine-to-heparin neutralization ratio is precisely calibrated for each lot
of protamine. Thromboplastin diluted in a buffer is used as an activator.
Sodium azide is added as a bacteriostatic agent. Table 1 lists the quantity
of protamine in each cartridge channel for a 1:110 neutralization ratio.
Table 1. Cartridge Protamine Concentrations
Color Range CH1 CH2 CH3 CH4 CH5 CH6
Red 0-0.9 mg/kg
0-1.2 u/mL
Yellow 0-1.5 mg/kg
0-2.0 u/mL
Tan 1.5-3.0 mg/kg
2.0-4.1 u/mL
Silver 2.0-3.5 mg/kg
2.7-4.8 u/mL
Micrograms of Protamine
0 0.8 1.6 2.4 - -
0 1.4 2.7 4.1 - -
4.1 5.4 6.8 8.2 - -
5.4 6.8 8.2 9.5 - -
Instructions for Use English 3
Color Range CH1 CH2 CH3 CH4 CH5 CH6
Blue 2.5-4.0 mg/kg
3.4-5.4 u/mL
Green 3.5-5.0 mg/kg
4.8-6.8 u/mL
Orange 0-2.5 mg/kg
0-3.4 u/mL
Gold 1.5-4.0 mg/kg
2.0-5.4 u/mL
White 2.5-5.0 mg/kg
3.4-6.8 u/mL
Purple 4.5-6.0 mg/kg
6.1-8.2 u/mL
Black 3.5-6.0 mg/kg
4.8-8.2 u/mL
Micrograms of Protamine
6.8 8.2 9.5 10.9 - -
9.5 10.9 12.2 13.6 - -
0 1.4 2.7 4.1 5.4 6.8
4.1 5.4 6.8 8.2 9.5 10.9
6.8 8.2 9.5 10.9 12.2 13.6
12.2 13.6 15.0 16.3 - -
9.5 10.9 12.2 13.6 15.0 16.3
5. Storage
Refer to cartridge package labeling for specific storage conditions and
expiration dates.
Note: Do not freeze.
5.1. Room Temperature
Heparin assay cartridges may be stored at room temperature
(10°C to 25°C [50°F to 77°F]) until the Use-By Date on the cartridge box.
Cartridges should be stored in the box so that the Use-By Date can be
referenced. Cartridges should be discarded if the Use-By Date is
unknown, or if the reagent has evaporated or appears contaminated.
5.2. Refrigerated
Heparin assay cartridges are stable until the Use-By Date indicated on the
cartridge box when stored at 2°C to 10°C (35.6°F to 50°F). Once a
cartridge is removed from the refrigerator and left at room temperature, it
must be used within 1 week or by the Use-By Date, whichever occurs first.
Once removed, cartridges cannot be returned to refrigeration.
6. Instrument
Medtronic heparin assay cartridges are designed specifically for use in the
Medtronic HMS Plus instrument. For HMS Plus instrument instructions,
consult the HMS Plus instrument Operator's Manual.
7. Specimen Collection and Preparation
Blood samples that are improperly drawn and handled can yield
erroneous test results; samples must be collected carefully, and handling
techniques must be consistent.
If blood is obtained by venipuncture, the venipuncture should be clean
and the first several milliliters of blood discarded to avoid contamination of
the sample with tissue thromboplastin. Blood should not be taken from
heparinized indwelling catheters or other anticoagulated lines without
thoroughly flushing the line.
Baseline samples, which contain no anticoagulant, should be tested within
60 seconds of collection. Heparinized samples should be tested within
2 minutes of collection.
8. Instructions for Use
This product is intended for use only by trained individuals.
4 Instructions for Use English
Materials supplied:
■
heparin assay cartridge
■
3-mL Monoject™ sterile, single-use syringe
■
19-ga, 36-mm (1 7/16-in) sterile, single-use, blunt needle
Materials required, not supplied:
■
test sample, fresh whole blood
■
Medtronic HMS Plus instrument
Steps:
1. Gently tap the heparin assay cartridge and place in the HMS Plus
actuator heat block. Heparin assay cartridges do not require
prewarming.
Note: If an HR-ACT (high-range activated clotting time) is tested with
the heparin assay cartridge, the HR-ACT cartridge must be
prewarmed at least 3 minutes.
2. Fill the supplied syringe with test sample in the following quantities:
■
4 channel heparin assay cartridge: 1.5 mL
■
4 channel heparin assay cartridge with HR-ACT: 2.5 mL
■
6 channel heparin assay cartridge: 2 mL
3. Attach and prime a clean blunt tip needle.
4. Insert the syringe into the dispenser of the HMS Plus instrument. Lock
the syringe in place. The dispenser will automatically deliver the
appropriate amount of test sample to each cartridge channel.
5. Press “Start/Stop” to initiate the test.
6. If the dispenser is not functioning, the test sample may be delivered
manually into each cartridge channel (consult the HMS Plus
instrument Operator's Manual for complete instructions).
Note: It is important to accurately deliver the test sample into each
cartridge channel.
9. Results
Upon test completion, the following information can be obtained:
■
the sample heparin concentration in mg/kg, u/mL, or u/kg; the
detection channel; as well as the run time of the detection channel
■
the average HR-ACT and individual HR-ACT channel clotting times (if
an HR-ACT test is performed)
■
additional heparin required for the patient, pump, or total volume to
maintain the desired heparin level
■
the protamine sulfate dose required to neutralize the patient, pump, or
total heparin concentration
For additional information regarding heparin assay results, consult the
HMS Plus instrument Operator's Manual.
10. Limitations
Medtronic heparin assay cartridges are for in vitro diagnostic use only and
are to be used only with the Medtronic HMS Plus instrument.
Cartridges that have been used for testing should be considered
hazardous. It is the responsibility of the user to dispose of the cartridge in
accordance with local regulations and institution procedures.
The accuracy of the heparin assay is dependent on the cartridge channel
resolution. This resolution varies from 0.3 to 0.5 mg/kg (0.4 to 0.7 u/mL)
depending on the cartridge range.
The accuracy and precision of heparin measurements are dependent on
the USP tolerances for heparin and protamine sulfate.
Instructions for Use English 5
The heparin measurement obtained is considered valid as long as the
sample heparin level is within the range of the selected cartridge. For
example, when a clot is detected in channel 1 of a heparin assay
cartridge, an alert message appears, indicating the heparin concentration
may be less than the measured value. When a clot is detected in the last
channel of the cartridge, an alert message appears, indicating that the
heparin concentration may be higher than the measured value.
Measurement of heparin concentration by protamine titration is generally
not affected by hypothermia, hemodilution, or platelet inhibitory drugs.
To obtain accurate and consistent heparin measurements, the following
must be observed:
1. Blood samples must be representative of the patient’s circulating
heparin.
2. To optimize precision, all technique variables should be held constant.
3. Patient diagnosis and medications should be noted. Tests should be
repeated if unexplained values are obtained. If necessary, a sample
can be citrated and sent to the laboratory for further analysis.
For HMS Plus instrument precautions and limitations, consult the
HMS Plus Operator's Manual.
11. Heparin Assay Cartridge Ranges
The following table lists the available heparin assay cartridges, the
measurement range for each cartridge, and the channel resolution.
Table 2. Cartridge Ranges
Color Units CH1 CH2 CH3 CH4 CH5 CH6 Reso-
Red mg/kg 0.0 0.3 0.6 0.9 - - 0.3
u/mL 0.0 0.4 0.8 1.2 - - 0.4
Yellow mg/kg 0.0 0.5 1.0 1.5 - - 0.5
u/mL 0.0 0.7 1.4 2.0 - - 0.7
Tan mg/kg 1.5 2.0 2.5 3.0 - - 0.5
u/mL 2.0 2.7 3.4 4.1 - - 0.7
Silver mg/kg 2.0 2.5 3.0 3.5 - - 0.5
u/mL 2.7 3.4 4.1 4.8 - - 0.7
Blue mg/kg 2.5 3.0 3.5 4.0 - - 0.5
u/mL 3.4 4.1 4.8 5.4 - - 0.7
Green mg/kg 3.5 4.0 4.5 5.0 - - 0.5
u/mL 4.8 5.4 6.1 6.8 - - 0.7
Purple mg/kg 4.5 5.0 5.5 6.0 - - 0.5
u/mL 6.1 6.8 7.5 8.2 - - 0.7
Orange mg/kg 0.0 0.5 1.0 1.5 2.0 2.5 0.5
u/mL 0.0 0.7 1.4 2.0 2.7 3.4 0.7
Gold mg/kg 1.5 2.0 2.5 3.0 3.5 4.0 0.5
u/mL 2.0 2.7 3.4 4.1 4.8 5.4 0.7
White mg/kg 2.5 3.0 3.5 4.0 4.5 5.0 0.5
u/mL 3.4 4.1 4.8 5.4 6.1 6.8 0.7
Black mg/kg 3.5 4.0 4.5 5.0 5.5 6.0 0.5
u/mL 4.8 5.4 6.1 6.8 7.5 8.2 0.7
lution
12. Specific Performance Characteristics
Heparin assay cartridges are designed to provide results within
30 to 249 seconds from the time of test initiation. Clotting in all channels
within 30 seconds of test initiation may indicate an activated test sample.
6 Instructions for Use English
Heparin assay run times greater than 249 seconds may indicate that
heparin levels exceed the cartridge range.
When 2 channels of the same cartridge clot simultaneously, the HMS Plus
instrument will display the result at the lower heparin concentration.
If the heparin concentration in a test sample is between the measured
value of 2 cartridge channels, the sample may clot in either of the
2 channels.
Table 3 shows accuracy and precision obtained with the heparin assay
cartridges. Tests were run on heparinized, recalcified plasma. The data
shows the results of 6 to 9 sequential heparin assay cartridges run on the
HMS Plus instrument.
Table 3. Cartridge Performance Characteristics
Heparin Level of
Plasma
Mean Measured Heparin Level
n
SDaCV
b
0.7 u/mL 0.7 u/mL 6 0 0
2.0 u/mL 2.0 u/mL 7 0 0
3.4 u/mL 3.4 u/mL 8 0 0
4.1 u/mL 4.1 u/mL 9 0 0
4.8 u/mL 4.8 u/mL 6 0 0
5.4 u/mL 5.3 u/mL 6 0.2 4.6%
a
Standard deviation
b
Coefficient of variation
The precision and accuracy of the heparin assay cartridges are
dependent on the USP and IU tolerances for heparin. The accuracy is
within the resolution of the applicable cartridge. The test accuracy is within
±½ channel (±0.2, or 0.4 u/mL for red, and ±0.35, or 0.7 u/mL for the other
cartridges). Precision for the heparin assay cartridges is illustrated in the
resolution column of Table 4.
Table 4. Cartridge Test Precision Example
Color Units CH1 CH2 CH3 CH4 CH5 CH6 Resolu-
tion
Red u/mL 0.0 0.4 0.8 1.2 - - 0.4
Yellow u/mL 0.0 0.7 1.4 2.0 - - 0.7
White u/mL 3.4 4.1 4.8 5.4 6.1 6.8 0.7
13. Quality Control
Heparin assay controls are used to verify instrument and cartridge
performance. Pass/fail criteria for the controls tests are programmed into
the HMS Plus instrument.
Note: If using only liquid controls, control tests must be performed every
8 hours of patient testing.
The HEPtrac electronic quality control is used to supplement liquid
controls and does not replace them. Refer to the current regulatory
agency guidelines on the acceptability and use of electronic controls.
14. References
1. Anido G, Freeman DJ. Heparin assay and protamine titration. Am J
Clin Pathol. 1981;76:410.
2. Bowie JE, Kemna GD. Automated management of heparin
anticoagulation in cardiovascular surgery. Proc Amer Acad Perfus.
1985;6:85.
3. Despotis GJ, et al. Comparison of activated coagulation time and
whole blood heparin measurements with laboratory plasma anti-xa
heparin concentration in patients having cardiac operations. J Thorac
Cardiovasc Surg. 1994;108:1076-82.
Instructions for Use English 7
4. Donahoo KM, et al. A promising new multi-functional instrument for
monitoring heparin therapy. Adv Therapy. 1985;2:150.
5. Fox DJ, et al. Vehicles of heparin management: A comparison. J
Extracorp Tech. 1979;11:137.
6. Hill AG, Lefrak EA. Monitoring heparin and protamine therapy during
cardiopulmonary bypass procedures. AMSECT Proceedings.
1978;6:8.
7. Kemna GD, Bowie JE. Heparin protamine management for
cardiopulmonary bypass patients with abnormal heparin dose
response. Proc Amer Acad Perfus. 1985;6:89.
8. NCCLS Document H21-A. 1986;6(20):596-597.
9. Pifarré R, et al. Management of postoperative heparin rebound
following cardiopulmonary bypass. J Thorac Cardiovasc Surg.
1981;81:378.
10. Triplett DA, Smith C. Sensitivity of the activated partial thromboplastin
time. Results of the CAP survey and a series of mild and moderate
factor deficiencies. In: Triplett DA, ed. Standardization of Coagulation
Assays: An Overview. Coll Am Pathol; 1981:142.
15. Disclaimer of Warranty
THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES
TO UNITED STATES CUSTOMERS ONLY:
ALTHOUGH THE HEPARIN ASSAY CARTRIDGES, HEREAFTER
REFERRED TO AS “PRODUCT,” HAVE BEEN MANUFACTURED
UNDER CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC HAS
NO CONTROL OVER THE CONDITIONS UNDER WHICH THIS
PRODUCT IS USED. MEDTRONIC, THEREFORE, DISCLAIMS ALL
WARRANTIES, BOTH EXPRESS AND IMPLIED, WITH RESPECT TO
THE PRODUCT, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BE LIABLE TO
ANY PERSON OR ENTITY FOR ANY MEDICAL EXPENSES OR ANY
DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED
BY ANY USE, DEFECT, FAILURE, OR MALFUNCTION OF THE
PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES IS BASED
UPON WARRANTY, CONTRACT, TORT, OR OTHERWISE. NO
PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY
REPRESENTATION OR WARRANTY WITH RESPECT TO THE
PRODUCT.
The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty is held to
be illegal, unenforceable, or in conflict with applicable law by a court of
competent jurisdiction, the validity of the remaining portions of this
Disclaimer of Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.
16. Disclaimer of Warranty
THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES
TO CUSTOMERS OUTSIDE THE UNITED STATES:
ALTHOUGH THE HEPARIN ASSAY CARTRIDGES, HEREAFTER
REFERRED TO AS “PRODUCT,” HAVE BEEN CAREFULLY
DESIGNED, MANUFACTURED, AND TESTED PRIOR TO SALE, THE
PRODUCT MAY FAIL TO PERFORM ITS INTENDED FUNCTION
8 Instructions for Use English
SATISFACTORILY FOR A VARIETY OF REASONS. THE WARNINGS
CONTAINED IN THE PRODUCT LABELING PROVIDE MORE
DETAILED INFORMATION AND ARE CONSIDERED AN INTEGRAL
PART OF THIS DISCLAIMER OF WARRANTY. MEDTRONIC,
THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESS AND
IMPLIED, WITH RESPECT TO THE PRODUCT. MEDTRONIC SHALL
NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL
DAMAGES CAUSED BY ANY USE, DEFECT, OR FAILURE OF THE
PRODUCT, WHETHER THE CLAIM IS BASED ON WARRANTY,
CONTRACT, TORT, OR OTHERWISE.
The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty is held by
any court of competent jurisdiction to be illegal, unenforceable, or in
conflict with applicable law, the validity of the remaining portion of the
Disclaimer of Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.
Instructions for Use English 9
Heparin-Testkartusche
1. Vorgesehener Verwendungszweck
Für die Verwendung zur Bestimmung der Heparinkonzentration einer
frischen Vollblutprobe nach der Protamintitrationsmethode.
Nur für die Verwendung in der In-vitro-Diagnostik.
2. Kurzbeschreibung
Medtronic Heparin-Testkartuschen führen eine semiquantitative
Bestimmung der Heparinkonzentration in einer Vollblutprobe durch. Die
Bestimmung der Heparinkonzentration erfolgt durch Titration gegen
bekannte Mengen Protamin, das den Kartuschenkanälen zugegeben wird.
Der Kanal, dessen Menge Protamin das Heparin in der Probe
neutralisiert, hat die kürzeste Gerinnungszeit. Die Heparinkonzentration
wird auf Grundlage der bekannten Protaminmenge berechnet. Zur
Beschleunigung der Reaktionszeit wird den Heparin-Testkartuschen
Thromboplastinverdünnung zugegeben. Heparin-Testkartuschen messen
Heparinspiegel von 0 bis 6,0 mg/kg Körpergewicht bzw. von 0 bis 8,2
E/ml. Heparin-Testkartuschen sind als 4- oder 6-Kanal-Kartuschen
erhältlich.
3. Anwendungsprinzip
Jeder Kanal der Heparin-Testkartusche enthält Protaminsulfat in
zunehmender Menge und eine gleichbleibende Menge
Thromboplastinverdünnung. Das Protamin in den einzelnen Kanälen
neutralisiert eine bestimmte Menge Heparin. Jedem Kartuschenkanal wird
eine frische Vollblutprobe zugegeben, und die Reagenzien werden durch
das Medtronic HMS Plus-Gerät mit der Testprobe vermischt, um die
Koagulation einzuleiten. Der erste Kanal, bei dem eine Gerinnung auftritt,
ist der Kanal, dessen Protaminmenge am besten die in der Testprobe
enthaltene Heparingesamtmenge neutralisiert, ohne dass ein Überschuss
an Heparin oder Protamin vorliegt.
Der Test endet, sobald eine Gerinnungsbildung erkannt wird. Das HMS
Plus-Gerät erkennt die Gerinnung an der Senkgeschwindigkeit des in
jedem Kartuschenkanal enthaltenen Kolbens. Bei einer nicht geronnenen
Probe senkt sich der Kolben schnell. Bei der Gerinnung bildet sich ein
Fibrinnetz, wodurch der Kolben mit geringerer Geschwindigkeit sinkt. Die
Gerinnung wird von einem fotooptischen Sensor im Betätigungselement
des Geräts registriert.
4. Reagenzien
Heparin-Testkartuschen enthalten Protaminsulfat für Injektionszwecke in
USP-Qualität (United States Pharmacopoeia). Das Protamin-zu-HeparinNeutralisierungsverhältnis ist für jede Protamincharge exakt kalibriert. Als
Aktivator wird Thromboplastinverdünnung in einem Puffer verwendet. Als
Bakeriostatikum wird Natriumazid zugesetzt. Tabelle 1 führt die
Protaminmenge in den einzelnen Kartuschenkanälen für ein
Neutralisierungsverhältnis von 1:110 auf.
Tabelle 1. Protaminkonzentrationen der Kartusche
Farbe Bereich KA1 KA2 KA3 KA4 KA5 KA6
Rot 0–0,9 mg/kg
0–1,2 E/ml
Gelb 0–1,5 mg/kg
0–2,0 E/ml
Protamin [Mikrogramm]
0 0,8 1,6 2,4 – –
0 1,4 2,7 4,1 – –
10 Gebrauchsanweisung Deutsch
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