Medtronic 306-05POR Instructions for Use

Heparin Assay Controls

Heparin-Assay-Gerinnungskontrollen
Controles del análisis de heparina
Contrôles de concentration d'héparine
Controlli per l'analisi dell'eparina
HPT-controlevloeistof

Instructions for Use ■ Gebrauchsanweisung ■ Instrucciones de uso ■
Mode d'emploi ■ Istruzioni per l'uso ■ Gebruiksaanwijzing

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.

Handelsmerken kunnen zijn geregistreerd en zijn het eig endom van de
desbetreffende eigenaars.

Explanation of symbols on package labeling / Erläuterung der
Symbole auf der Verpackung / Explicación de los símbolos en el
etiquetado del envase
sur l'emballage / Spiegazione dei simboli sulle etichette della
confezione / Verklaring van de symbolen op de

/ Explication des symboles des étiquettes

verpakkingslabels

1

2

Conformité Européenne (European Conformity). This
symbol means that the device fully complies with
European Council Directive IVDD 98/79/EC.
Conformité Européenne (Europäische Konformität).
Dieses Symbol besagt, dass das Gerät die
Anforderungen der Richtlinie 98/79/EG des
Europäischen Rats über Medizinprodukte für die
In-Vitro-Diagnostik (IVDD) vollständig erfüllt. /
Conformité Européene (Conformidad Europea).
Este símbolo indica que el dispositivo cumple
totalmente la Directiva 98/79/CE del Consejo Europeo
sobre productos sanitarios para diagnóstico in vitro.
Conformité Européenne. Ce symbole signifie que le
dispositif est entièrement conforme à la Directive
européenne relative aux dispositifs médicaux de
diagnostic in vitro IVDD
Européenne (Conformità europea). Questo simbolo
significa che il dispositivo è conforme alla Direttiva del
Consiglio Europeo IVDD 98/79/CE.
Européenne (Europese Conformiteit). Dit symbool
betekent dat het product volledig voldoet aan de richtlijn
van de Europese Raad IVDD 98/79/EG.

Quantity / Menge / Cantidad / Quantité / Quantità /
Aantal

98/79/CE. / Conformité

/

/

/ Conformité

Consult Instructions for Use / Gebrauchsanweisung

/ Consultar las instrucciones de uso /

beachten
Consulter le mode d'emploi / Consultare le istruzioni per

/ Raadpleeg de gebruiksaanwijzing

l'uso

In Vitro Diagnostic Medical Device / Medizinprodukt für
die In-vitro-Diagnostik / Dispositivo médico para
diagnóstico in vitro / Dispositif médical de diagnostic in

/ Dispositivo medico diagnostico in vitro / In-vitro

vitro
diagnostisch medisch apparaat

Temperature Limit / Temperaturbereich / Límite de
temperatura / Limite de température / Limiti di
temperatura

Nonsterile / Unsteril / No estéril / Non stérile /
Non sterile / Niet-steriel

Do Not Reuse / Nicht wiederverwenden / No reutilizar /
Ne pas réutiliser / Non riutilizzare / Niet opnieuw
gebruiken

For US Audiences Only / Gilt nur für Leser in den USA /
Sólo aplicable en EE.UU. / Ne s'applique qu'aux États­Unis / Esclusivamente per il mercato statunitense /
Alleen van toepassing voor de VS

/ Temperatuurbereik

3

4

Biological Risks / Biogefährdung / Riésgos biológicos /
Risques biologiques / Rischi biologici / Biologisch
gevaar

Catalog Number / Katalognummer / Número de

/ Numéro de référence / Numero di catalogo /

catálogo
Catalogusnummer

Control / Gerinnungskontrolle / Control / Contrôle /
Controllo / Controlevloeistof

Reconstitute with X mL of Deionized Water / Mit X ml
deionisiertem Wasser rekonstituieren / Reconstituir con
X mL de agua desionizada
d'eau déionisée / Ricostituire con X ml di acqua
deionizzata / Reconstitueren in X ml gedemineraliseerd
water

/ Reconstituer avec X ml

Water / Wasser / Agua / Eau / Acqua / Water

Lot Number / Losnummer / Número de lote / Numéro de
lot / Codice del lotto / Partijnummer

Use-By Date / Zu verwenden bis einschließlich / No
utilizar después de
entro / Uiterste gebruiksdatum

Authorized Representative in the European
Community
Gemeinschaft / Representante autorizado en la
Comunidad Europea / Représentant agréé dans la
Communauté européenne
nella Comunità europea / Geautoriseerd
vertegenwoordiger in de Europese Gemeenschap

/ À utiliser jusqu'au / Utilizzare

/ Autorisierte Vertretung für die Europäische

/ Rappresentante autorizzato

5

6

1 Intended Use

To verify the performance of the HMS Plus and heparin assay cartridges.
For in vitro diagnostic use.

2 Summary

Heparin assay controls enable users of the HMS Plus instrument to verify the
performance of the instrument and the heparin assay cartridges.

3 Principles

Heparin assay controls contain sheep plasma and United States Pharmacopoeia
(USP) porcine heparin. The controls are designed to perform in the heparin assay
cartridges in a manner similar to a patient’s blood sample. The control contains
heparin that forms an inactive salt when combined with the protamine sulfate
(protamine) in the heparin assay cartridge. The first cartridge channel to clot indicates
the quantity of protamine that most closely matches the quantity of heparin in the
control sample. The other channels contain either an excess of heparin or an excess
of protamine, which gives an extended clotting time.

Six levels of heparinized controls are available. Table 1 shows the appropriate control
to use with each of the 4-channel heparin assay cartridges and the required
performance.
cartridges.

Table 2 shows use and performance in the 6-channel heparin assay

English Instructions for Use 7

Protamine sulfate is a weak anticoagulant in sheep plasma, therefore there may be
little difference in channels
of the 6-channel cartridges. As a result, either channel may be detected first. The USP
tolerance for protamine and heparin places limitations on the accuracy of the test. The
range of tolerances is approximately the sum of the USP tolerances for heparin and
protamine.

3 and 4 of the 4-channel cartridges and channels 5 and 6

8 English Instructions for Use

Table 1. Required Performance of the Heparin Assay Controls in 4-Channel Heparin
Assay Cartridges

Heparin
Assay

Control

Red/Yellow 0.0-0.9

Red/Yellow 0.0-1.5

Tan / Si l ve r 1.5-3.0

Tan / Si l ve r 2.0-3.5

Blue/Gold 2.5-4.0

Green/White 3.5-5.0

Purple/Black 4.5-6.0

Cartridge
Typ e
(mg/kg)

(Red)

(Yellow)

(Tan)

(Silver)

(Blue)

(Green)

(Purple)

Cartridge
Typ e
(U/mL)

0-1.2 4 <249

0-2.0 3 or 4 <249

2.0-4.1 4 <249

2.7-4.8 3 or 4 <249

3.4-5.4 3 or 4 <249

4.8-6.8 3 or 4 <249

6.1-8.2 3 or 4 <249

Required
Channel
Detection

Required
Clotting
Time (sec)

English Instructions for Use 9

Table 2. Required Performance of the Heparin Assay Controls in 6-Channel Heparin
Assay Cartridges

Heparin
Assay
Control

Orange 0.0-2.5

Blue/Gold 1.5-4.0

Green/White 2.5-5.0

Purple/Black 3.5-6.0

Cartridge
Typ e
(mg/kg)

(Orange)

(Gold)

(White)

(Black)

Cartridge
Typ e
(U/mL)

0-3.4 5 or 6 <249

2.0-5.4 5 or 6 <249

3.4-6.8 5 or 6 <249

4.8-8.2 5 or 6 <249

Required
Channel
Detection

Required
Clotting
Time (sec)

4 Reagents

Heparin assay controls are formulated from sheep plasma and USP porcine heparin.
Table 3 shows the quantity of heparin added to each control type.

10 English Instructions for Use

Table 3. Concentration of Heparin in Heparin Assay Controls

Heparin Assay Control Heparin (U/mL)

Red/Yellow 1.6
Orange 4.1
Tan / Si l ve r 5.2
Blue/Gold 6.5
Green/White 8.2
Purple/Black 9.8

5 Storage

Lyophilized heparin assay controls must be refrigerated (2°C to 10°C [35.6°F to 50°F])
until use. The controls are stable until the expiration date noted on the control vial.
Once reconstituted, controls are stable for 2
(2°C

to 25°C [35.6°F to 77°F]).

hours at refrigerated or room temperature

6 Procedure

1. Bring controls to room temperature. Each vial contains enough control sample to
run 1 cartridge. Use the control/cartridge combinations shown in Tables
The control type will be indicated by the HMS

2. Using a syringe, add 2.5 mL of deionized water (packaged with the controls) to
each control vial. Do not shake.

Plus instrument when the test is run.

1 and 2.

3. Allow the control sample to rehydrate for at least 3 minutes.

4. Invert gently 2 to 3 times to thoroughly mix.

English Instructions for Use 11

5. Insert the heparin assay cartridge into the HMS Plus instrument.

6. From the “Main Menu:”
a. Select “Quality Control.”
b. Fill a clean 3-mL Monoject syringe and blunt tip needle (packaged with the

cartridges) with the control sample.
c. Prime the needle, then insert the syringe and needle into the dispenser.
d. Press “Start/Stop.” The display will confirm the appropriate control to be

used. Verify that the control being used matches the display.
e. Press “Start/Stop” again to start the test.
f. When the test is complete, the detected heparin concentration and run time

will be displayed.
g. Press “Print” to generate a printout of the results. The printout will indicate

that the test is a Quality Control test. The test will also be stored in

the

Note: The heparin assay control cannot be run at the same time as the

Quality Control Test History.

HR-ACT

control, due to the incubation period for the HR-ACT control.

7 Results

The HMS Plus instrument display and printout will indicate “PASS” or “FAIL.”
Detection in an incorrect channel or a clot time >249 seconds will result in a failed test.
Refer to Tables 1 and 2 for performance criteria.

12 English Instructions for Use

8 Limitations

Heparin Assay Controls are for in vitro diagnostic use only and are to be used only with
the HMS Plus instrument. Even though the controls are of nonhuman origin, all
biological samples should be considered potentially hazardous and should be handled
according to institution procedures.

The results are dependent on good technique and proper adherence to protocol. Strict
adherence to rehydration requirements is recommended.

The clotting time and channel detected are valid only when the control and cartridge
have been stored as indicated.

The deionized water is nonsterile.
To ensure that the control performs properly, reconstitution should be achieved using

only the enclosed deionized water.
If the results do not agree with those stated in Tables 1 and 2, perform the following

steps:

1. Determine if the HMS Plus instrument temperature is properly adjusted according
to the procedures given in the HMS

Plus instrument operator’s manual.

2. Determine that neither the cartridge nor the control has expired.

3. Inspect the vial for visible clot formation. If clots are present in the vial, the control
may have deteriorated.

4. Repeat the test with a new vial of control.

5. Report any unresolved problems to Medtronic.

English Instructions for Use 13

9 Disclaimer of Warranty

THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO UNITED STATES
CUSTOMERS ONLY:

DISCLAIMER OF WARRANTY

ALTHOUGH THE HEPARIN ASSAY CONTROLS, 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.

14 English Instructions for Use

THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO CUSTOMERS
OUTSIDE THE UNITED STATES:

DISCLAIMER OF WARRANTY

ALTHOUGH THE HEPARIN ASSAY CONTROLS, HEREAFTER REFERRED TO
AS “PRODUCT,” HAVE BEEN CAREFULLY DESIGNED, MANUFACTURED AND
TESTED PRIOR TO SALE, THE PRODUCT MAY FAIL TO PERFORM ITS
INTENDED FUNCTION 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.

English Instructions for Use 15

16 English Instructions for Use

1 Verwendungszweck

Zur Kontrolle der ordnungsgemäßen Funktion der HMS Plus- und Heparin-Assay­Kartuschen.

Zur In-vitro-Diagnostik.

2 Kurzbeschreibung

Heparin-Assay-Gerinnungskontrollen ermöglichen die Überprüfung der einwandfreien
Funktion des Gerinnungszeitmessgeräts HMS
Kartuschen.

Plus und der Heparin-Assay-

3 Anwendungsprinzip

Heparin-Assay-Gerinnungskontrollen enthalten Plasma vom Schaf und USP-(United
States Pharmacopoeia-)Heparin vom Schwein in einer solchen Zusammensetzung,
dass sie in Heparin-Assay-Kartuschen ein einer Blutprobe vom Patienten vergleich­bares Verhalten zeigen. Das in der Gerinnungskontrolle enthaltene Heparin reagiert
mit dem in der Heparin-Assay-Kartusche enthaltenen Protaminsulfat zu einem
stabilen Salz. Der Kartuschenkanal, in dem zuerst Gerinnung auftritt, gibt den
Protamingehalt an, der dem Heparingehalt in der Kontrollprobe am ehesten
entspricht. Die anderen Kanäle enthalten einen Überschuss an Heparin oder
Protamin, der zu einer verlängerten Gerinnungszeit führt.

Es stehen sechs heparinisierte Gerinnungskontrollen zu Verfügung. Tabelle 1 gibt die
jeweils mit den einzelnen 4-Kanal-Heparin-Assay-Kartuschen zu verwendende
Gerinnungskontrolle und das geforderte Ergebnis an.
und das geforderte Ergebnis für 6-Kanal-Heparin-Assay-Kartuschen an.

Tabelle 2 gibt die Verwendung

Deutsch Gebrauchsanweisung 17

Protaminsulfat wirkt in Plasma vom Schaf schwach antikoagulierend. Daher kann es
in den Kanälen
6-Kanal-Kartuschen zu geringen Unterschieden kommen. Dies führt dazu, dass die
erste Gerinnung wahlweise in einem der beiden genannten Kanäle auftritt. Die USP­Toleranzbereiche für Protamin und Heparin bedingen Einschränkungen der Test­genauigkeit. Der Toleranzbereich entspricht ca. der Summe der USP-Toleranzbereiche
für Heparin und Protamin.

3 und 4 der 4-Kanal-Kartuschen und in den Kanälen 5 und 6 in den

18 Deutsch Gebrauchsanweisung

Tabelle 1. Gefordertes Ergebnis von Heparin-Assay-Gerinnungskontrollen für
4-Kanal-Heparin-Assay-Kartuschen

Heparin­Assay-

Gerinnungs­kontrolle

Rot/Gelb 0,0-0,9

Rot/Gelb 0,0-1,5

Gelbbraun/
Silber

Gelbbraun/
Silber

Blau/Gold 2,5-4,0

Grün/Weiß 3,5-5,0

Violett/Schwarz 4,5-6,0

Kartuschen­typ
(mg/kg)

(Rot)

(Gelb)
1,5-3,0

(Gelbbraun)
2,0-3,5

(Silber)

(Blau)

(Grün)

(Violett)

Kartuschen­typ
(E/mL)

0-1,2 4 <249

0-2,0 3 oder 4 <249

2,0-4,1 4 <249

2,7-4,8 3 oder 4 <249

3,4-5,4 3 oder 4 <249

4,8-6,8 3 oder 4 <249

6,1-8,2 3 oder 4 <249

Gerinnungs­kanal

Erforderte
Gerinnungszeit
(s)

Deutsch Gebrauchsanweisung 19

Tabelle 2. Gefordertes Ergebnis von Heparin-Assay-Gerinnungskontrollen für 6-Kanal­Heparin-Assay-Kartuschen

Heparin­Assay­Gerinnungs­kontrolle

Orange 0,0-2,5

Blau/Gold 1,5-4,0

Grün/Weiß 2,5-5,0

Violett/
Schwarz

Kartuschen­typ
(mg/kg)

(Orange)

(Gold)

(Weiß)
3,5-6,0

(Schwarz)

Kartuschen­typ
(E/mL)

0-3,4 5 oder 6 <249

2,0-5,4 5 oder 6 <249

3,4-6,8 5 oder 6 <249

4,8-8,2 5 oder 6 <249

Gerinnungs­kanal

Erforderte
Gerinnungszeit
(s)

4 Reagenzien

Heparin-Assay-Gerinnungskontrollen enthalten Plasma vom Schaf und USP-Heparin
vom Schwein. In
angegeben.

Tabelle 3 wird die jedem Kontrolltyp hinzugefügte Heparinmenge

20 Deutsch Gebrauchsanweisung